[Senate Hearing 117-497]
[From the U.S. Government Publishing Office]
S. Hrg. 117-497
Senate Hearings
Before the Committee on Appropriations
_______________________________________________________________________
Departments of Labor,
Health and Human Services,
and Education, and Related
Agencies Appropriations
Fiscal Year 2022
117th Congress, First Session
H.R. 4502
DEPARTMENT OF EDUCATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
DEPARTMENT OF LABOR
NONDEPARTMENTAL WITNESSES
S. Hrg. 117-497
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2022
=======================================================================
HEARINGS
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
ON
H.R. 4502
AN ACT MAKING APPROPRIATIONS FOR THE DEPARTMENTS OF LABOR, HEALTH AND
HUMAN SERVICES, AND EDUCATION, AND RELATED AGENCIES FOR THE FISCAL YEAR
ENDING SEPTEMBER 30, 2022, AND FOR OTHER PURPOSES
__________
Department of Education
Department of Health and Human Services
Department of Labor
Nondepartmental Witnesses
__________
Printed for the use of the Committee on Appropriations
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
_________
U.S. GOVERNMENT PUBLISHING OFFICE
44-181 PDF WASHINGTON : 2023
COMMITTEE ON APPROPRIATIONS
PATRICK LEAHY, Vermont, Chairman
PATTY MURRAY, Washington RICHARD C. SHELBY, Alabama, Vice
DIANNE FEINSTEIN, California Chairman
RICHARD J. DURBIN, Illinois MITCH McCONNELL, Kentucky
JACK REED, Rhode Island SUSAN M. COLLINS, Maine
JON TESTER, Montana LISA MURKOWSKI, Alaska
JEANNE SHAHEEN, New Hampshire LINDSEY GRAHAM, South Carolina
JEFF MERKLEY, Oregon ROY BLUNT, Missouri
CHRISTOPHER A. COONS, Delaware JERRY MORAN, Kansas
BRIAN SCHATZ, Hawaii JOHN HOEVEN, North Dakota
TAMMY BALDWIN, Wisconsin JOHN BOOZMAN, Arkansas
CHRISTOPHER MURPHY, Connecticut SHELLEY MOORE CAPITO, West
JOE MANCHIN, III, West Virginia Virginia
CHRIS VAN HOLLEN, Maryland JOHN KENNEDY, Louisiana
MARTIN HEINRICH, New Mexico CINDY HYDE-SMITH, Mississippi
MIKE BRAUN, Indiana
BILL HAGERTY, Tennessee
MARCO RUBIO, Florida
Charles E. Kieffer, Staff Director
Shannon Hutcherson Hines, Minority Staff Director
------
Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
PATTY MURRAY, Washington, Chairman
RICHARD J. DURBIN, Illinois ROY BLUNT, Missouri, Ranking
JACK REED, Rhode Island RICHARD C. SHELBY, Alabama
JEANNE SHAHEEN, New Hampshire LINDSEY GRAHAM, South Carolina
JEFF MERKLEY, Oregon JERRY MORAN, Kansas
BRIAN SCHATZ, Hawaii SHELLEY MOORE CAPITO, West
TAMMY BALDWIN, Wisconsin Virginia
CHRISTOPHER MURPHY, Connecticut JOHN KENNEDY, Louisiana
JOE MANCHIN, III, West Virginia CINDY HYDE-SMITH, Mississippi
PATRICK J. LEAHY, Vermont, (ex MIKE BRAUN, Indiana
officio) MARCO RUBIO, Florida
Professional Staff
Alex Keenan
Kelly Brown
Michael Gentile
Mark Laisch
Megan Mott
Kathryn Toomajian
Laura A. Friedel (Minority)
Anna Lanier Fischer (Minority)
Ashley Palmer (Minority)
Emily Slack (Minority)
Administrative Support
Fiona O'Brien
Sydney Crawford (Minority)
C O N T E N T S
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HEARINGS
Wednesday, May 19, 2021
Page
Review of the Fiscal Year 2022 Budget Blueprint for the Centers
for Disease Control and Prevention............................. 1
Wednesday, May 26, 2021
Department of Health and Human Services: National Institutes of
Health......................................................... 69
Wednesday, June 9, 2021
Department of Health and Human Services: Office of the Secretary. 155
Wednesday, June 16, 2021
Department of Education: Office of the Secretary................. 247
Wednesday, July 14, 2021
Department of Labor: Office of the Secretary..................... 365
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BACK MATTER
Departmental Witnesses........................................... 435
America's Public Television Stations and the Public
Broadcasting Service....................................... 435
National Public Radio........................................ 440
List of Witnesses, Communications, and Prepared Statements....... 857
Nondepartmental Witnesses........................................ 443
Subject Index.................................................... 863
America's Public Television Stations and the Public
Broadcasting Service....................................... 863
Department of Education: Office of the Secretary............. 863
Department of Health and Human Services...................... 864
National Institutes of Health............................ 864
Office of the Secretary.................................. 865
Department of Labor: Office of the Secretary................. 866
Review of the Fiscal Year 2022 Budget Blueprint for the
Centers for Disease Control and Prevention................. 867
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2022
----------
WEDNESDAY, MAY 19, 2021
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10 a.m. in room SD-138, Dirksen
Senate Office Building, Hon. Patty Murray (chairwoman)
presiding.
Present: Senators Murray, Durbin, Reed, Shaheen, Merkley,
Schatz, Baldwin, Murphy, Manchin, Blunt, Shelby, Graham, Moran,
Capito, Kennedy, Hyde-Smith, Braun, and Rubio.
REVIEW OF THE FISCAL YEAR 2022 BUDGET BLUEPRINT FOR THE CENTERS FOR
DISEASE CONTROL AND PREVENTION
opening statement of senator patty murray
Senator Murray. Good morning. The Senate Appropriations
Subcommittee on Labor, Health and Human Services, Education,
and Related Agencies will come to order.
Today we are having a hearing on the Biden administration's
fiscal year 2022 Budget request for the Centers for Disease
Control and Prevention. It is our first subcommittee hearing
this Congress, and our first hearing on the CDC's annual
funding request since 2014.
Senator Blunt and I look forward to continuing to work with
you and our colleagues on both sides of the aisle, to build on
the progress we have made previously, and help families in
Washington State, Missouri, and across the country.
And I intend to follow the example you set when it came to
chairing hearings, Senator Blunt, and making sure that every
member has an opportunity to ask a question.
Senator Blunt and I will each have an opening statement.
And then I will introduce our witnesses, Director Walensky, and
Principal Deputy Director Schuchat. And after the witness'
testimony, Senators will each have 5 minutes for a round of
questions.
Before we begin, I do want to walk through the COVID-19
safety protocols in place. We are all very grateful to our
clerks, and everyone who has worked hard to get this set up and
help everyone stay safe and healthy.
Given the new guidance from the Centers for Disease Control
and Prevention and the Office of the Attending Physician, I
will be working with Senator Blunt, committee members and
staff, going forward, to follow the new guidance.
For today, we will be conducting this hearing following
similar COVID protocols to what we have used in the past.
Committee members are seated at least 6 feet apart. Some
Senators are participating by video conference, and while we
are unable to have the hearing fully open to the public, or
media for in-person attendance, live video is available on our
committee website.
And if you are in need of accommodations, including closed
captioning, you can reach out to the committee or the office of
Congressional Accessibility Services.
I always say a budget is a reflection of your values and
your priorities. And I think Americans can breathe a sigh of
relief knowing this budget shows they have a President who
values science and public health. COVID-19 has offered a stark
reminder of why we must make and maintain robust investments in
public health.
Experts at CDC (Centers for Disease Control and Prevention)
have been on the frontlines of this crisis from day one, and
every day since. We have seen first-hand how critical it is CDC
be equipped to effectively collect and analyze data in real
time, communicate science-based public health guidance, help
communities across the country get tests, and vaccines, and
clear, reliable information to people, and address inequities
that undermine the health of people of color, people with
disabilities, rural communities, and others.
That is why I have pushed for more funding for public
health throughout this crisis. The tens of billions of dollars
we have provided through six COVID bills so far, are supporting
invaluable public health work at every level so we can finally
end this pandemic.
It has helped update and modernize data systems needed to
track infections, variants, tests, vaccines, and inequities
among demographic groups. It has helped fight misinformation
and promote simple protective measures that have saved
countless lives, like wearing masks and social distancing.
It has helped expand our testing efforts, get vaccines into
arms, and build partnerships with trusted voices in hard-to-
reach communities. And I was pleased to hear the Biden
administration announced last week, it was investing over $7
billion from the American Rescue Plan, through CDC, to create
tens of thousands of jobs in public health at the State and
local level to fight COVID-19, and to help transition some of
those workers to permanent careers as public health
professionals.
With new cases and deaths both down over 80 percent from
their winter peaks, nearly three in five Americans vaccinated
with their first dose, and over a third of Americans fully
vaccinated, we can see the light at the end of the tunnel. But
even as we get closer to ending this crisis, we know we are not
there yet, and we cannot afford to come up short. That is why
after years of underinvestment in CDC and attempted cuts to CDC
by President Trump, this budget request is such a breath of
fresh air.
President Biden's request of $8.7 billion would increase
CDC's budget authority by nearly a quarter. I have been pushing
for more public health funding for years now. And I am excited
to say this would be the largest budget authority increase for
CDC in nearly two decades. These investments will help us
finish strong when it comes to this pandemic, prepare for the
next one, and make progress on other public health challenges.
Investments in CDC, as well as requested increases for the
Substance Abuse and Mental Health Services Administration will
help address the record number of drug overdose deaths, and the
spike in mental health issues, we have seen as a result of this
pandemic. COVID-19 has also put a painful spotlight on how
racism, sexism, ableism and bigotry hurt so many people in this
country.
CDC's recent announcement of a 2-year plan to invest more
than $2 billion to work on COVID-19-related health disparities
was an important step towards addressing this reality, and the
administration's request to dramatically increase the social
determinants of health program, Congress established at CDC
last year from 3 million to 153 million will help make sure our
response to health inequities is truly comprehensive, because
there are so many challenges we need to tackle head-on.
For example, Black, American Indian, and Alaska Native
women are two to three times more likely to die from pregnancy-
related causes than White women. And our overall maternal
mortality rate is the worst in a developed country, so I am
glad the administration budget request includes $200 million to
reduce maternal mortality nationwide, and address disparities,
an increase of 140 million.
It also invests in other public health threats that have
gone too long with too little attention. It doubles funding for
gun violence prevention research, and establishes a new 100
million community-based violence intervention program between
CDC and the Department of Justice. And it increases funding for
CDC's climate and health program by $100 million dollars.
Of course, the challenges we face are bigger than any one
budget. Before this pandemic hit, only half of Americans were
served by a comprehensive public health system. Our public
health workforce has lost 56,000 people, and State health
officials estimated a quarter of their workforce was eligible
to retire.
So we have a lot of work ahead, not just to end this
pandemic, but to build and maintain a public health system
capable of addressing other pressing public health challenges
and, of course, preparing for future ones.
That is why earlier this year I reintroduced the Public
Health Infrastructure Saves Lives Act, which would finally end
the dangerous cycle of crisis and complacency in public health
funding by providing dedicated annual investments in public
health.
Director Walensky, Principal Deputy Director Schuchat, I
look forward to hearing from both of you about how investments
like this, and like those put forward in the administration's
budget request, can help families and States across the
country. And I look forward to working with my colleagues to
make the investments we need a reality.
Finally, Dr. Schuchat, I understand you are leaving CDC
this summer after 30 years with the agency. And I know I speak
for absolutely everyone on this committee, when I say I am
grateful, grateful that we have had your expertise and
leadership, helping to see our Nation through so many public
health challenges. Thank you for your service, from all of us.
And with that, I will turn it over to Senator Blunt for his
remarks.
statement of senator roy blunt
Senator Blunt. Well, thank you, Chair Murray. This is your
first hearing as the Labor, Health and Human Services chair. I
certainly look forward to working with you in this role. We
have had a lot of success working together in the past 6 years
on this subcommittee, and I am sure we can continue with that
this year.
I also want to share your welcome to the CDC director and
the principal deputy director.
Dr. Schuchat, thanks for your service to our country, and
your incredible time at CDC. As I mentioned to you earlier as
we were visiting, I am sure there is not a single person who
knows as much about CDC as you do. And there may never be a
person who knows as much as you do after a 33-year career
there, and that long list of things that we have worked
together on in the last several years, but a list that goes
beyond that.
So Dr. Walensky, Dr. Schuchat, this is really an important
opportunity for us to hear about the CDC's budget proposal, and
understand more about CDC's priorities for this year. I don't
think there has been a year that CDC got more attention than it
got in the last year. And so the profile of CDC, the
understanding of the importance of CDC I think, is at a high
point.
I want to recognize the tireless efforts of the CDC staff,
working across the country during the pandemic. It has been a
challenging year for all Americans, but particularly for those
in public health.
Dr. Walensky, I look forward to hearing your testimony
today on the administration's fiscal year 2022 Budget.
Unfortunately, your comments will be limited somewhat by the
fact that we are really waiting for more information about that
budget. But from what we do know from the limited details
released last month, there are several areas of alignment where
we can work together.
For example, addressing the needs of the hard-hit public
health infrastructure, responding to the opioid crisis, which
has been exacerbated during the pandemic, along with other
mental health and behavioral health challenges, and continuing
the Ending the HIV Epidemic Initiative are important to both of
us.
These are critical areas that may need even more attention
as we emerge from the pandemic and gain an understanding of the
full impact, of the health impact, and the behavioral health
impact that the pandemic has had.
It also appears that Global Health Security and
Preparedness programs will continue as a priority for this
administration, as it has been for this subcommittee over the
past 6 years. During that time the subcommittee invested
heavily in these programs, increasing funding across the
department of HHS (Department of Health and Human Services) by
46 percent. Unfortunately, the so-called ``skinny budget'' also
includes what I believe are excessive areas of increases in
areas that are extremely partisan. I hope we can set those
issues aside and invest in areas of common ground that benefit
all Americans.
As this subcommittee thinks about the priorities for fiscal
year 2022, I hope we can spend time learning from the lessons
of the pandemic.
In 2020, Congress passed five bipartisan COVID relief
bills, total more than $16 billion for CDC. During the
infectious disease pandemic, that funding was critical for
State and local public health preparedness and response. I
think we would all agree that our focus on local public health
in this country is not what it was just a few decades ago, and
we can do better. Certainly those agencies and State
governments, generally, have been critical in the vaccine
distribution and planning.
Now, the other point to make is that $16 billion is a lot
of funding to absorb. To put it in perspective that is about
double your annual budget, or more than $50 million per day for
the CDC's response efforts last year.
Pretty hard to spend all of that as effectively as this
committee would like, but I think we understood that when we
were sending money to CDC to try to respond to a pandemic that
was unlike anything we had dealt with before.
We also really need to incorporate the lessons learned from
the pandemic, moving forward. It is important we highlight what
went right, when communities stepped up, when neighbors helped
neighbors, when innovators came forward to provide novel
solutions to some of the problems that plagued the pandemic.
Senator Durbin, and I, and seven of our colleagues went out
Monday to NIH (National Institutes of Health), and we saw what
happened there with testing and other things that, clearly, I
think as we look down the road, those are going to be great
advantages for us. In Missouri we saw a lot of those unique
things happen.
For example, the pandemic brought out innovation with
Washington University in St. Louis--Dr. Walensky, where you got
one of your degrees--developing their own COVID test, when
there was a nationwide shortage of testing, there was a test
that was developed at the Washington University campus to be
used on that campus.
Other resilience came through, other resourcefulness came
through. Throughout Missouri, independent and rural pharmacists
would drive 200 miles, some of them, to be sure they had the
vaccine that would be available at their location the very next
day, literally, going the extra mile, and the University of
Missouri developed a cutting-edge technology to track COVID
variants through wastewater epidemiology.
So I am proud of Missourians. I am proud of Americans
across the country, as we reached out to deal with this. We are
clearly not out of the woods yet. We need to continue to
understand and learn from the mistakes we made to figure out
where we fell short or missed the mark.
Also to understand, frankly, that there were lots of things
we know now that we did not know then. And looking back at
decisions where you don't have the same information, or
anything like it that we did now is a challenge. We need to
figure out what we learned from that, how we could have found
out more, earlier. I expect the budget to do just that. I want
to work with Senator Murray and others on this committee to do
that.
But under your leadership Dr. Walensky, I hope the agency
will make the difficult decisions necessary to make great
strides toward the enormous opportunity that I think public
health has at this moment, for the rest of this century. So
thank you for being with us today.
Chair, again, let me say, I look forward to your leadership
and the things that we can do together, and I really appreciate
where we are now compared to where we were 6 years ago. And I
think our partnership was an important part of that.
[The statement follows:]
Prepared Statement of Senator Roy Blunt
Thank you, Chair Murray. This is your first hearing as the Labor/
HHS Chair and I look forward to working with you in this role. We have
had a lot of success the past six years working together on this
Subcommittee and I'm sure it will continue this year. I also want to
share your welcome to the CDC Director and the Principal Deputy
Director.
Dr. Walensky and Dr. Schuchat, this is an important opportunity for
us to hear about the CDC's budget proposal and understand more about
the CDC's priorities for this year. I also want to recognize the
tireless efforts of the CDC staff working across the country during the
pandemic. This has been a challenging year for all Americans, but
especially those who work in public health.
Dr. Walensky, I look forward to hearing your testimony today on the
Administration's fiscal year 2022 budget. Unfortunately, I think your
comments will be limited because we are still waiting for the
Administration to release their budget. What we do know, from the
limited details released last month, is that there are several areas of
alignment where we can work together. For example, addressing the needs
of the hard hit public health infrastructure; responding to the opioid
crisis, which has been exacerbated during the pandemic; and continuing
the Ending the HIV Epidemic initiative, are important to both of us.
These are critical areas that may need even greater attention as we
emerge from the pandemic and gain a better understanding of its full
impact on our nation's public health.
It also appears that global health security and preparedness
programs will continue as a priority for this Administration, as it was
for the Labor/HHS Subcommittee over the past six years. During that
time, this Subcommittee invested heavily in these programs, increasing
funding across the Department of Health and Human Services by 46
percent.
Unfortunately, the so-called ``skinny'' budget also includes
excessive increases in areas that are extremely partisan. I hope we can
set those issues aside and invest in areas of common ground that
benefit all Americans.
As this Subcommittee thinks about priorities for fiscal year 2022,
I hope we will spend time learning from the lessons of the pandemic. In
2020, Congress passed five bipartisan COVID relief bills, totaling more
than $16 billion for the CDC. During a global infectious disease
pandemic, that funding was critical for state and local public health
preparedness and response; for public health data modernization; and
for COVID-19 vaccine distribution.
However, $16 billion is a lot of funding for the CDC to absorb. To
put it in perspective, that is about double your annual budget or more
than $50 million per day for the CDC's response efforts last year. Our
Subcommittee has a responsibility to provide oversight and ensure
accountability of that funding for the taxpayers.
We also must incorporate the lessons learned during the pandemic
moving forward. But as important, we should highlight what went right.
When communities stepped up. When neighbors helped neighbors. And when
innovators came forward to provide novel solutions to some of the
problems that plagued the pandemic.
And in Missouri, we saw a lot of that.
For example, the pandemic brought out innovation, with Washington
University in St. Louis developing their own COVID-19 diagnostic test
when there was a nationwide testing shortage.
It brought out resilience and resourcefulness. Throughout Missouri,
independent and rural pharmacists will drive 200 miles a day to provide
vaccines to vulnerable and underserved populations. They are literally
going the extra mile to ensure communities and rural areas across our
state have access to the vaccine.
And it brought out ingenuity. The University of Missouri is
developing cutting-edge technology to track COVID variants through
wastewater epidemiology.
I am proud of how Missourians, and Americans across the country,
stepped up to respond during this crisis.
But, we are not out of the woods yet. We need to continue to
understand and learn from the mistakes we made. Figure out where we
fell short or missed the mark. And I would expect the CDC's fiscal year
2022 budget to do just that. This is the time to think about a long-
term strategy and not continue to jump from one disease outbreak to the
next.
The CDC is facing unprecedented challenges, but the agency is also
presented with an enormous opportunity to bring public health into the
21st Century. Under your leadership, Dr. Walensky, I hope the agency
will make the difficult decisions necessary to make great strides to
that end. Thank you for being with us today and I look forward to your
testimony.
Thank you.
Senator Murray. Thank you, Senator Blunt. And yes, I do
look forward to working with you on this as we always have. So
I appreciate it.
I want to welcome both of our witnesses again. Thank you
for being here.
Dr. Rochelle Walensky is the director of the Centers for
Disease Control and Prevention, and the administrator of the
Agency for Toxic Substances and Disease Registry.
Dr. Anne Schuchat is the principal deputy director of CDC,
and has twice served as acting director of the agency. Welcome
to you both.
Dr. Walensky, we will begin with you for your opening
remarks.
STATEMENT OF DR. ROCHELLE WALENSKY, DIRECTOR, CENTERS
FOR DISEASE CONTROL AND PREVENTION
Dr. Walensky. Chairman Murray, Ranking Member Blunt, and
everyone on the committee, I am grateful for the committee's
support of the CDC.
I am here today, as you noted, with Dr. Anne Schuchat,
CDC's principal deputy director. I have enormous gratitude for
Dr. Schuchat's leadership and contributions over three decades,
as well as during this very challenging period during our--for
our country, and for her rock-solid support of me in my
transition into this role.
Anne embodies selfless public service, the pinnacle of
scientific and intellectual standards, and has given her heart
to our agency and the public health community. I will be
forever grateful that our paths crossed even for such a short
period of time.
The COVID-19 pandemic threw the United States and the world
into a health, economic, and humanitarian crisis. As the crisis
unfolded, it put a spotlight on the fragility of our public
health infrastructure. It illuminated great disparities in
health outcomes by race and ethnicity; reminding us that--thus
far--we have failed to address the systemic racism that results
in poorer health for people of color in the United States.
I am committed to working with you, the administration, and
our public health partners to ensure that every lesson from
this horrible crisis is used to build a better, stronger,
healthier America.
I also commit to using our public health expertise and
experience in partnership with the global community to move the
world into a safer, healthier future. CDC's fiscal year 2022
Discretionary Budget Request of $8.7 billion is an increase of
$1.6 billion over fiscal year 2021--the largest increase CDC
has received in nearly 20 years.
The increase is focused on four critical areas: building
public health infrastructure, reducing health disparities,
using public health approaches to reduce violence, and
defeating diseases and epidemics.
These increases build on the investments made in the COVID-
19 supplementals, and are an important first step in addressing
deficits in the public health infrastructure. COVID-19 not only
exposed the vulnerabilities within the United States public
health infrastructure, but also how underlying chronic
conditions and lack of access to healthcare, put too many
Americans at great risk.
Across the globe we see billions of people without access
to vaccines and medical care, which means that SARS-CoV-2, its
variants, and other infectious disease threats will continue to
threaten us all. Experts had warned for years that a pandemic
of this scale was coming, and we must expect additional
diseases to emerge.
We need to ask ourselves, are we ready? We must have a
strong infrastructure that can identify and detect outbreaks at
their source and can take quick action before diseases take
hold.
Over the last 12 years, the United States has faced four
significant emerging infectious disease threats: the H1N1
influenza pandemic, Ebola, Zika, and COVID-19; we also
confronted a drug overdose epidemic with nearly 500,000 people
dying from an opioid-related overdose between 1999 and 2019.
This increase continued into 2020 and appeared to accelerate
during the COVID-19 pandemic.
These experiences show that public health emergencies are
here to stay. Each of those threats demanded a rapid and unique
response, but none resulted in a sustained public health
improvement. Long-term investments in flexible infrastructure
will save lives and avert economic losses caused by public
health emergencies and chronic public health problems.
The fiscal year 2022 request makes initial investments to
continue public health data modernization, build the public
health workforce, enhance global health security, and
strengthen our immunization infrastructure.
In addition, we are requesting funds to help states and
communities be climate-ready and prepare to confront new health
risks, such as those associated with vector-borne diseases. The
fiscal year 2022 Budget Request also makes specific investments
in programs that work to improve health equity, such as
maternal mortality review committees. With these new outlined
resources in this request, CDC will also significantly expand
efforts to address the social determinants of health.
Proposed increases will address public health problems that
have been exacerbated by this pandemic, such as opioids,
violence, HIV, and sexually-transmitted diseases.
We, at CDC, are grateful for your support and look forward
to working together to build a sustainable and resilient public
health system that can respond effectively to emerging threats,
and meet the public health needs of every American. We will
work tirelessly to ensure the health of this Nation and the
world.
Thank you. Dr. Schuchat and I look forward to your
questions.
[The statement follows:]
Prepared Statement of Rochelle P. Walensky, M.D., M.P.H. and
Anne Schuchat, M.D.
Chairwoman Murray, Ranking Member Blunt, and distinguished members
of the Committee, it is an honor to appear before you today to discuss
how investments in the Centers for Disease Control and Prevention (CDC)
are protecting American's health, now and in the future. I am grateful
for this opportunity to address this committee, as well as for your
long-standing and consistent leadership on issues of critical
importance to the health of Americans, and the world.
It is my privilege to represent CDC at this hearing. CDC is
America's health protection agency. For 75 years, CDC has been trusted
to carry out its mission to protect America's safety, health, and
security. Even during the unprecedented circumstances of the past year,
CDC's scientific expertise, determination, selflessness, and innovation
has helped the agency continue to advance its mission. We work 24/7 to
prevent illness, save lives, and protect America from threats to our
health, safety, and security. Addressing infectious diseases and
pandemics, like COVID-19, is central to our mission. CDC's expertise
lies in our ability to study emerging pathogens like SARS-CoV-2, to
understand how they are transmitted, and to translate that knowledge
into timely action to protect the public's health. CDC identifies and
mitigates other causes of morbidity and mortality beyond infectious
diseases, such as environmental and workplace hazards and intentional
and unintentiona l injuries (such as those from falls, violence, or
overdose). CDC promotes healthy behaviors, such as exercise and
nutrition, to prevent chronic diseases such as diabetes and heart
disease, and to prevent outcomes such as stroke. We promote healthy
communities by increasing access to nutritious food and safe walking
and green space.
By deploying experts on the ground to support our state, Tribal,
local, territorial and global partners, we translate science into
implementing guidance that protects individua ls, communities, and
populations. In our work with other Federal agencies we ensure the safe
and appropriate use of medical countermeasures, including vaccines, and
collaborate with the academic and private sector to further our
understanding of new diseases and problems that affect health.
The COVID-19 pandemic threw the United States and the world into a
health, economic, and humanitarian crisis. As the crisis unfolded, it
put a spotlight on pre-existing weaknesses and gaps that threaten the
health of Americans. It brought into stark light the great disparities
in health outcomes by race and ethnicity. We must acknowledge the long-
standing and too often unstated impact that racism has on public
health. The pandemic has also highlighted our frail public health
infrastructure, and the way that frailty impacted our ability to
respond at thenecessary scale and speed.
Experts had warned for years that a pandemic of this scale was
coming. Today, we know to expect additional novel and currently rare
diseases to emerge and gain footing as a result of our changing
climate, closer interaction with animals, and globalization. Over the
last 12 years, the United States has faced four significant emerging
infectious disease threats--the H1N1 influenza pandemic, Ebola, Zika,
and COVID-19. These experiences show that public health emergencies
and, specifically, infectious disease threats, are here to stay. While
urgency demanded rapid and unique responses to each of these threats,
none resulted in the sustained improvements needed in our nation's
public health infrastructure. This lack of robust public health
infrastructure continues to present significant challenges in our
ongoing fight against COVID-19. In fact, emergencies have resulted in
the rapid build-up of infrastructure needed to address the emergency,
then dissolution of that infrastructure, often leaving no sustainable
infrastructure in place to address the next threat. This lack of robust
public health infrastructure continues to present significant
challenges in our ongoing fight to tackle COVID-19.
World-wide, billions of people do not and will not have immediate
access to COVID-19 vaccines. Cases will continue to increase, and
variant COVID-19 strains are likely to emerge, persist, and cause
outbreaks. As this becomes more common, our public health system at
home and abroad must be ready with highly sophisticated detection and
sequencing, combined with a rapid response at the source. The
unprecedented investments provided to CDC through COVID-19 supplemental
appropriations have helped our efforts to control COVID-19, and will
also go a long way toward addressing deficits in the core components of
the public health infrastructure that has long been ignored. Our
ability to respond to the next public health crisis will depend on
whether we invest in a public health system that is highly functional
on a day-to-day basis and pivots to meet new threats, rather than
continue our partial defense, which ramps up in response to an urgent
and often short-term event.
A resilient public health system can be realized with careful
planning that builds on the gains made with COVID-19 emergency
supplementals and incorporates lessons learned as a result of this
crisis, including reliable, flexible funding. The FY 2022 Discretionary
Budget Request for CDC and ATSDR includes a total funding request of
$8.7 billion, an increase of $1.6 billion over FY 2021 Enacted. This is
the largest increase in budget authority for CDC in nearly two decades
and defends Americans' health in four ways: 1) building public health
infrastructure, 2) reducing health disparities, 3) using public health
approaches to reduce violence, and 4) defeating other diseases and
epidemics.
First, building the public health infrastructure. CDC's FY 2022
request prioritizes foundational funding to rebuild the public health
infrastructure needed to safeguard the Nation's health and economic
security. Drawing on lessons learned, as well as the latest information
and technologies, CDC will begin to address long-standing
vulnerabilities in the U.S. public health network by training a larger
cadre of experts who can deploy and support public health efforts, and
building capacity to detect and respond to emerging global biologica l
threats.
Public health action is driven by data. Earlier improvements in our
systems for collecting information after other public health
emergencies, including Ebola and EVALI, facilitated exchange of health
information, linking local, state, and federal public health systems
with healthcare systems and the public. With investments in public
health data modernization in the FYs 2020 and 2021 appropriations and
the COVID-19 supplementals, CDC increased the scale and speed of these
systems during the COVID-19 response to protect people who are at risk
for severe illness (such as older Americans), those with chronic
medical conditions, and those from racial and ethnic minorities. These
advancements must be applied across the public health system and at all
levels of government. The funds requested in FY 2022 will be used to
continue building a modern disease surveillance system at CDC, which
will catalyze a multi-sectoral, comprehensive, and cohesive approach to
documenting evidence, using state-of-the-art technology and analytical
tools. CDC will continue working diligently to ensure its research and
data are of the highest quality and are disseminated nationally to
inform decision-making throughout the public health system, while
supporting advances in data systems at all levels.
The COVID-19 pandemic made clear the role that CDC labs and public
health labs across the nation play in conducting critical surveillance
and responding to outbreaks and emerging threats. CDC and state
laboratories were required to flex and surge during peak periods of
illness, far beyond routine clinical testing. In FY 2019, CDC was only
able to meet 50% of state and local health departments' stated needs
for epidemiology and laboratory capacity funding, with personnel
support being the biggest unfunded need, followed by equipment and
supplies.
The FY 2022 request will foster innovation, collaboration with the
clinical system, and a commitment to quality. Improving technologies at
the state and local levels would enable public health labs to quickly
utilize and scale up essential laboratory analyses. In a post-COVID-19
world, investments to maintain and improve laboratories will help
prevent the failures we experienced while trying to address COVID-19.
The U.S. needs a workforce of qualified public health professionals
who will prepare for, respond to, and prevent public health crises.
Physicians working for states often earn less than$150,000 per year.
This is after having taken on medical school debt of $200,000 on
average. The FY 2022 request includes an increase to build a diverse
and culturally competent workforce who can rapidly develop innovative
approaches in surveillance and detection, risk communications,
laboratory science, data systems, and disease containment. With this
funding, CDC will support critical training programs for public health
professionals that develop strategic and systems thinking, data
science, communication, and policy evaluation. Existing cooperative
agreement mechanisms will be leveraged to support public health jobs
that meet current needs and attract new personnel to work in
underserved and rural areas.
Addressing gaps in capacity across levels of government to detect
and respond to outbreaks while maintaining and surging in other problem
areas requires investments to be disease-agnostic and flexible. With FY
2022 funding, CDC will provide support to health departments to meet
national quality standards, conduct performance improvement activities,
increase communication and collaboration across the public health
system, and reshape health departments to meet changing conditions and
needs. Funding will help health departments strengthen their abilities
to effectively respond to a range of public health threats, such as
COVID-19, and build capacities that do not currently exist.
COVID-19 is a sobering reminder that a disease threat anywhere is a
disease threat everywhere. Or as stated by WHO: no one is safe unless
everyone is safe. We cannot adequately protect American lives and the
U.S. economy without addressing global disease threats wherever they
may arise. CDC's strategic investments in global health security are
critical to U.S. health security by building sustainable global
capacity to prevent, detect, and respond to emerging infectious disease
threats. CDC works in more than 60 countries on more than 150 projects
and is a key implementing agency for the U.S. Government's leadership
role in the Global Health Security Agenda. With additional resources
requested in FY 2022, CDC will build on existing partnerships with
Ministries of Health, public health agencies, infectious disease
research institutions, and international organizations to strengthen
global laboratory capacity for early disease detection, enhance disease
surveillance for accurate data to drive decision making, and foster
effective regional and global coordination.
Next, I'd like to talk about reducing health disparities. The
disparities seen over the past year among communities of color were not
a result of COVID-19. In fact, the pandemic illuminated inequities that
have existed for generations and revealed a known, unaddressed, and
serious public health threat: racism. The well-being of our entire
nation will be compromised as long as we fail to address this.
Racism is not just discrimination against one group based on the
color of their skin or their race or ethnicity, but the structural
barriers that impact racial and ethnic groups differently to influence
where a person lives, where they work, where their children play, and
where they worship and gather in community. The social determinants of
health (SDOH)--such as high-quality education, stable and fulfilling
employment opportunities, safe and affordable housing, access to
healthful foods, commercial tobacco-free policies, and safe green
spaces for physical activity--are critical drivers of health inequities
in this country. CDC is building the evidence-base for collaborative
approaches to SDOH through community accelerator planning and expanding
a network of community health workers to develop a sustainable
infrastructure to improve health equity. CDC's FY 2022 budget request
includes an increase of $150 million to use a social determinants of
health approach to improve health equity and health disparities in
racial and ethnic minority communities and other disproportionately
affected communities around the country.
This budget directly responds to health disparities recorded in our
public health data. For example, about 700 women die each year in the
U.S. as a result of pregnancy or delivery complications, and American
Indian, Alaska Native, and Black women are two to three times more
likely to die than White women. Data show that about 2/3 of these
deaths may be preventable. Children from lower-income and racial and
ethnic minority households experience a disparate, increased risk for
lead exposure.
Achieving health equity is central to addressing the HIV epidemic.
The U.S. government spends $20 billion per year in direct health
expenditures for HIV care and treatment. An estimated 1.2 million
persons have HIV and approximately 15% are unaware they have it. With
recent advancements in antiretroviral therapy and biomedical
advancements in HIV prevention, such as pre-exposure prophylaxis
(PrEP), along with effective care and treatment, we have the tools to
end the HIV epidemic. An increased investment requested in FY 2022 for
the Ending the HIV Epidemic (EHE) initiative will enable CDC to advance
the four key strategies needed to end the epidemic in the 57 EHE focus
jurisdictions. In addition, CDC will address health equity in the
entire HIV prevention portfolio, test innovation in service delivery
models to increase access to prevention services, use syndemic
approaches to broaden reach to key populations and create efficiencies,
and strengthen engagement of grassroots community-based organizations
in implementing EHE initiative.
Third, the budget request also addresses the public health epidemic
of violence. We know too well how this epidemic permanently alters the
lives of its victims and their families and puts enormous strain on our
communities and local economies. Increases in CDC's FY 2022 budget
request will help address violence through public health approaches,
which include improving reporting systems that provide the data needed
to understand and address violent deaths and injuries in the United
States.
And fourth, we must defeat other diseases and epidemics. Just as
racism underlies a number of public health issues, climate issues
underlie a number of infectious diseases and have significant health
impacts. Climate changes are associated with changes in the
geographical range of mosquitos, ticks, and other disease vectors.
Climate-related events impact a wide range of health outcomes. Some of
the most significant climate-related events--such as heat waves,
floods, droughts, and extreme storms--affect everyone. These climate
events compromise our access to clean air, clean water, and a reliable
food supply. In addition, climate events can impact the presence of
allergens and vectors, like ticks and mosquitoes, and the subsequent
health outcomes that can result from these changes in exposures. We
know that a changing climate can intensify existing public health
threats, and that new health threats will emerge: unequally distributed
risks (age, economic resources, location), increased respiratory and
cardiovascular disease, injuries and premature deaths related to
extreme weather events, changing prevalence and geography of foodborne
and waterborne illnesses and other infectious diseases, and threats to
mental health as people feel less safe.
CDC works with states, cities, and tribes to apply the best climate
science available, predicting health impacts, and preparing public
health programs to protect their communities. To do this, CDC developed
the Building Resilience Against Climate Effects (BRACE) framework to
help communities prepare for the health effects of climate change by
anticipating climate impacts, assessing vulnerabilities, projecting
disease burden, assessing public health interventions, developing
adaptation plans, and evaluating the impact and quality of activities.
With the requested increase in FY 2022, we can further expand the
Climate and Health Program by providing a larger number of health
departments with technical assistance and funding and finding
innovative ways to protect health via climate adaptations. As with
every other public health threat, we will inform our effort by building
and examining systems that collect data on conditions related to
climate, including asthma and vector-borne diseases, and coordinate
programs and communication that improve health outcomes.
The opioid epidemic has shattered families, claimed lives, and
ravaged communities across the Nation--and the COVID-19 pandemic has
only deepened this crisis. Addressing the current overdose epidemic
remains a priority for CDC. The Administration's strategy brings
together surveillance, prevention, treatment, recovery, law
enforcement, interdiction, and source-country efforts to address the
continuum of challenges facing this country due to drug use. CDC's role
is to prevent drug-related harms and overdose deaths.
The additional funding requested in FY 2022 to address the opioid
epidemic will enable CDC to provide more funding to all States,
Territories, and select cities/counties. CDC will prioritize support to
collect and report real-time, robust overdose mortality data and to
move from data to action, building upon the work of the Overdose Data
to Action (OD2A) program. To do so, CDC will partner with funded
jurisdictions to implement surveillance strategies that include
contextual information alongside data, as well as increase surveillance
capabilities for polysubstance use and emerging substance threats such
as stimulants. The additional resources requested will enable CDC to
support investments in prevention efforts for people put at highest
risk, for example, supporting risk reduction and access to medications
for opioid use disorder for people transitioning from alternate
residence (jail/prison, treatment facility, homeless shelter). CDC will
also address infectious disease consequences, such as viral hepatitis,
of the opioid epidemic.
I look forward to working together to address both the immediate
challenges ahead in our fight against COVID-19, as well as the
weaknesses in the public health infrastructure that left our country
vulnerable to this pandemic. We at CDC are grateful for your support.
We will continue to work tirelessly to ensure the health of this nation
and the world. Together, we can build a sustainable and resilient
public health system that can respond effectively to emerging threats
and also to ongoing public health needs of every American.
Senator Murray. Thank you very much. And we will now begin
a round of 5-minute questions of our witnesses. And I do ask my
colleagues to keep track of the clock, and if you can stay
within those 5 minutes.
Dr. Walensky, COVID has really exposed the importance of
having a robust and well-funded public system before a crisis
strikes; which is why I said it is so important that we make
sustained investments in public health infrastructure and
workforce a priority, including in CDC.
Over the last year Congress provided more than $8 billion
to support public health data modernization and expand the
public health workforce through six COVID supplemental bills.
What more needs to be done to sustain our public health
infrastructure and our workforce, so we don't lose gains when
the funding runs out?
Dr. Walensky. Thank you so much, Senator, for that
question.
INFRASTRUCTURE AFTER EMERGENCY
You have highlighted that we have had challenges with our
public health workforce, indeed. We have 56,000--we are down
56,000 jobs just in the last decade. We need to train and
upskill that workforce, in addition to bolster that workforce
over the years ahead. We need to keep them trained because the
science continues to evolve, we need training in
bioinformatics, in genomic epidemiology, and all of that needs
to live in our State and localities so that they are well
informed and trained over time, not just in creating a
workforce, but in keeping them skilled.
We need to do data modernization, as you noted, an initial
investment in data modernization. When I spoke early on in my
tenure to State and local health officials, I was hearing about
faxes of test results for COVID, and then manual data entry of
those results, and that those results were not received with
racial and ethnic data in them. So we had no way of tracking
how we were doing with racial and ethnic diversity across this
pandemic.
And then we need to build our public health labs. We don't
have--did not have the capacity to do genomic sequencing in all
of these labs, we have had to scale that up. And there is many
more, and in the infrastructure in the machinery, in the
technology that we need to put and deploy, not just at CDC, so
we are ready at CDC for this, but also in our public health and
localities.
Senator Murray. So I am curious; if we had had all that in
place before this pandemic, how would have things been
different?
Dr. Walensky. I think they would have been extraordinarily
different. We would have had contact tracers on the ground
ready to go. We would have been able to identify cases quickly.
We would have been able to see single, single outbreaks than in
clusters that we might have been able to pin down to contact
trace and not have outbreaks expand. I think we would not have
seen the diverse--the racial discrepancy and what happened with
this pandemic that----
Senator Murray. Because we would have known prior and made
more of a focus?
Dr. Walensky. Exactly. We would have been able to find it.
I think the testing, the inability of our public health systems
to be able to conduct these tests in massive scale up, did not
allow us to find the disease where it was, certainly, we had
not done genomic sequencing until January, we did not know
anything about the variants that were circulating here. There
are numerable ways that this could have gone better if we had
had a more robust public health infrastructure across all of
those domains.
Senator Murray. Thank you. That is a lot to think about. We
should all remember. We have now seen a lot of encouraging
progress against COVID over the last several months, and as
more people get vaccinated, and case counts, and
hospitalization, deaths are falling.
PANDEMIC TRAJECTORY
Dr. Walensky, speak to us about where we are in this fight.
How the funds Congress has provided have helped? And what we
need to focus on next to bring this crisis to an end?
Dr. Walensky. Today, I am cautiously optimistic. We have,
in the last several weeks, seen a stark downward trend in
cases. The last 2 days we have had case rates that have been
less than 20,000 per day. Our case rates now are around 30,000
per day, on average, for the last seven days; death rates, we
have been seeing at around 500 a day, still too high, but the
lowest we have seen since this pandemic began.
We have over 86 percent of Americans over the age of 65 who
have received their first dose of vaccine. And just yesterday--
today we have now 60 percent of Americans over the age of 18
having received their first dose of vaccine. I think that we
have had extraordinary progress, and we have needed the
resources to get here.
Senator Murray. So what do we need to focus on next?
Dr. Walensky. Certainly, a sustainable public health
infrastructure that is not necessarily just tied to one
disease, to one outbreak, to one disaster. We need longitudinal
money so that we are able to have sustainable infrastructure
that is up to date with the times. We need to focus on our
racial and ethnic minority groups.
They were previously under-vaccinated. We have made a huge
amount of strides just in the last 2 weeks in getting those
groups vaccinated. But we need to--and we need to get into the
communities. We need to have a public health infrastructure
that looks like the communities that they serve, and that
serves those communities a lot.
Senator Murray. Should we be worried about the variants?
Dr. Walensky. I think we would be remiss to say that we are
out of the woods. This pandemic, this virus has sent us too
many curve balls to say that we--too early to declare victory.
Certainly, with the virus circulating in other parts of the
world that is in high degree that it gives the opportunity for
more variants to emerge, so I still am--it is among the things
that keeps me up at night. But right now the variants that we
see here and we are doing a lot of sequencing now, demonstrate
that our current vaccines are working.
Senator Murray. Okay. Thank you very much.
Senator Blunt.
Senator Blunt. Thank you, Chair.
CHANGES TO MASK GUIDANCE AND REOPENING
Let's talk about the guidance that came out last week on
masks for people who have been fully vaccinated. There seems to
be some concern about how that would be applied. I listened
this morning to the CEO (Chief Executive Officer) at Target,
who was on CNBC, and he said that--they had followed all the
CDC guidance up till now, which meant until last week people in
their stores had a mask on, this week people in their stores
don't have a mask on unless they want to have a mask on.
In the Capitol, the attending physician, who has been the
person we look to, put out guidance last week that said: on the
Capitol grounds you would not need to wear a mask if you were
vaccinated, but the Speaker decided that she was going to keep
the mask mandate in place for the House until everyone was
vaccinated.
What are you seeing there? And what kind of further
direction have you been able to give? I know just yesterday the
President had his mask on part of the time, largely based, it
seemed to me, on what other people around him were comfortable
with. But give us some more thoughts on that.
Dr. Walensky. Thank you, Senator, for that question. I
think the first thing that we should do is celebrate where we
are in this pandemic, that we can even be having this
conversation, that cases are now down to 19,000 a day, reported
this morning. As those cases are coming down, people are
longing to understand what this means next.
How do we open up again? How do we take our masks off? With
those cases coming down, and now the fact that every American
who wants a vaccine has access to one, if you have not texted,
text your zipcode to GETVAX (438829), you can find vaccine
wherever you are in the country. Five pharmacies will show up
so you can get the vaccine.
So we now have cases coming down and access to vaccines for
everyone who wants one. Just in the last 2 weeks, we had
scientific data emerge in three important areas, (1) that the
vaccines are working in the public the way they worked in the
clinical trials. That doesn't always happen, but it happened
here. And we had one of the largest studies published on Friday
in the MMWR (Morbidity and Mortality Weekly Report).
(2) That the vaccines are working against the variants we
have here circulating in the United States. There have been
data, neutralizing data that demonstrates against B.1.1.7,
against B.1.351. These vaccines are working.
And (3), something that was not studied in the clinical
trials is, can you--if you were to get infection with SARS-CoV-
2 and were vaccinated, could you give it to somebody else? Were
you silently able to spread it? Those data were not covered in
the clinical trials, but now data have emerged again, that have
demonstrated, even if you were to get infected during post-
vaccination, that you cannot give it to anyone else.
Senator Blunt. Yes.
Dr. Walensky. So that scientific data was enough for us to
move forward. People had said we moved too slowly, people have
said we have moved too fast, we moved at the speed that the
science gave us.
Senator Blunt. Well, I think that is right. I do think on
the last topic if we--not evaluating, whether we could have
made that decision quicker. But I do think that decision that
you don't have to wear a mask once you have been fully
vaccinated, will encourage people to get vaccinated. I think
the fact that that is out there is good. I hope we got it out
there as quick as you were comfortable having it out there.
RACIAL DISPARITIES
On your comments about racial health disparities which, of
course, I am not for racial health disparities, and more than
happy to look at that; what about the other obvious health
disparities, like how low income, health disparities regardless
of race, or rural health disparities? Are we just going to
focus on racial health disparities, and leave those others
behind? Or why were those the disparities you specifically
mentioned in your comments?
Dr. Walensky. We have seen a lot of data on racial health
disparities in this pandemic. But, Senator, you are absolutely
right. Twenty percent of Americans live in rural areas. As we
talk about social determinants of health, this is not just
racial--on racial lines, this is urban and rural.
We just, yesterday, had an MMWR come out that demonstrated
that rural Americans were getting vaccinated around 39 percent,
while non-rural counties were at 46 percent. So we are intent,
and our values are going to be, to have public health reach all
areas, all Americans.
Senator Blunt. I am glad to hear that. My last question
here before I run out of time would be on drug overdose deaths.
You know, we saw this committee work really hard on this topic
for about four straight years, and we felt we were making some
real progress. And I think we were, the numbers were going down
every year, but in 2020 we had the highest number to date of
drug overdose deaths. Just comment briefly on that before my
time is up here.
Dr. Walensky. It is tragic. Before being here, I was an
infectious disease doc on the wards at Mass General, and while
we were talking about deaths, the people on the wards were also
talking about chronic infections, endocarditis, epidural
abscesses, leaving young people paralyzed.
So we were making some progress, and this pandemic hindered
that progress. And we, again, need to address this issue.
Senator Blunt. Thank you.
Senator Murray. Thank you.
Senator Durbin.
Senator Durbin. Thank you, Madam Chairman.
And Dr. Schuchat, let me join the chorus. Thank you for 33
years of remarkable service. I have a question for you in a
minute, but I wanted to start with a little different approach.
LESSONS LEARNED
And let me say that I think this pandemic has not broken
us, but it has taught us where our system is broken, and there
are many areas we need to look at seriously. If you take a look
at the public health scorecard and try to find an objective
measure, the one that I return to frequently is the fact that
the United States has less than 5 percent--has less than 5
percent of the world's population, yet 20 percent of the COVID-
19 infections and deaths. And that tells us we can improve
dramatically.
Where did we shine in this effort? Certainly vaccines, the
quick response as we learned again this week, and the visit to
the NIH, was because we were prepared, and we had the science
ready, and we had good fortune in identifying the culprit, and
in devising an effective strategy to go after it with vaccines.
I would also add that the Warp Speed program appears to
have dedicated and invested funds in a dramatic way at a time
when it was very important. And I think that accelerated the
availability of the mass vaccines, and I give the Biden
administration credit for administering them, and distributing.
So those are the positive sides.
But one of the messages learned, that I learned out at NIH,
was now let's get honest about this. We not only have to bring
this pandemic to an end, we have to prepare for the next
pandemic, which may be 5 years away or 15 years away. We don't
know. But history tells us there will be another one. And the
question is: will we be ready for it?
The CDC is going to play a critical role in this. And the
first question I have to ask is to Dr. Schuchat. After 33 years
of observing this agency and its role in the American scene
when it comes to public health, there is a fear that it has
been politicized in the last 4 years, or maybe even before.
That now public health issues are so political, with the
division on whether to get a vaccine, or a vaccination or not,
seems to break out on party lines and political lines. We have
reached a new stage.
What is your thinking? And having observed and worked with
the CDC all these years, about this politicization--if that is
the word--of public health?
Dr. Schuchat. Thank you so much for your comments and your
question. The viruses don't vote, and the pandemic has really
told us that everyone is vulnerable, everyone in America, and
everyone around the world. And CDC is a science-based agency,
and we lead from science. We are data-driven, and we work
together with State and local partners who reflect the values
of their communities. So I think that focusing on the science
and the service mission of the agency is what we need to do.
Senator Durbin. Have you noticed any change, recent change
in terms of the political image of CDC, which tries to be
apolitical?
Dr. Schuchat. You know, this pandemic has been so difficult
for--you know, for the Nation, I think for all of us in public
health, and certainly for our colleagues around the world. The
messaging has really been difficult, you know, very conflicting
messages that left Americans confused.
And so I think we are committed to clear, honest
communication of what we know, and what we don't know, and what
we recommend people do. So I do think the messaging environment
during this pandemic has been really tough.
Senator Durbin. I would agree with that.
GUN VIOLENCE
Dr. Walensky, I am worried about gun violence. I believe it
is a public health issue because I represent the State of
Illinois and the City of Chicago. And we have the equivalent of
a mass shooting every weekend in Chicago. It is a disaster in
terms of its impact on the lives of many people, and the life
of the city.
You have a proposal to make a-hundred-million-dollar
investment through the CDC, in community-based violence
intervention, working with neighborhood organizations and
hospitals to deliver services. I recommend to you a program,
which we started in Chicago called the HEAL Initiative. I will
send you some information on it. But I would like for you to
say a few words about what you anticipate that $100 million is
going to be used for.
Dr. Walensky. Thank you, Senator. Our intent here is to
look for areas in high-violence cities, where we can accumulate
data, we can get accurate information, where we have actionable
interventions to prevent all areas of violence, community
violence, domestic violence, suicide, to increase public health
using those resources in areas that have been highly impacted.
We want actionable interventions for prevention.
Senator Durbin. Thank you.
CHILD MENTAL HEALTH
Madam Chair, I would just say in closing, you are in a
unique position being on the Authorizing and Appropriating
Committee, but one element I hope we don't overlook, and I know
you feel sensitive to this as I do, is the need in schools to
have access to counselors, mental health counselors, and maybe
traditional school nurses, so that any public health effort,
which should focus first on our children, has the wherewithal
to do that effectively. I find that we have allowed that to
lapse in many areas of my State.
Senator Murray. Thank you, Senator Durbin.
Senator Hyde-Smith.
Senator Hyde-Smith. Thank you, Chairwoman Murray, and
Ranking Member Blunt for having this hearing. And I certainly
appreciate the speakers that are here today.
And Dr. Walensky, I appreciate being able to visit with you
last week to discuss your work as director at the CDC. I
thought we had a very good conversation, I certainly admire the
work that you have done.
And Dr. Schuchat, I certainly admire the work that you have
done over the past many years.
RURAL HEALTH DISPARITIES
I will be brief with my questions, but one thing that I am
really concerned about is rural healthcare. I had the
opportunity this past Saturday morning to visit with David
Ready. He is a pharmacist in a town in Mississippi, Monticello,
Mississippi; that has less than 1,500 people, and the concerns
that he has about them being able to get their medicines. The
reimbursements they get, because they are so small, they don't
buy in bulk.
So those are things that I am sure that we will be having
other conversations about. But the COVID-19 pandemic has
highlighted numerous aspects, obviously, of our healthcare
system that need improvements. One of them that we all
recognize is the disparities of Americans living in rural
health areas.
Addressing health infrastructure in rural areas is a
serious concern, and as I said, one of my top priorities, and
while the CDC has undertaken efforts to address that, there is
no entity within the CDC tasked specifically with this work.
And that is concerning to me.
I believe establishing a new Office of Rural Health within
the Center of Disease Control would be an important way to
support rural communities through the end of this pandemic, and
to prepare for any other future public health crises that we
could be faced with.
And, you know, I just envision this office to be empowered
to look across CDC programs, to ensure the work of the agency
is properly addressing the health needs of the 57 million
Americans who live in rural communities.
Director Walensky, how strongly do you support establishing
an official Office of Rural Health within the CDC? And how can
we work together to get this done, if you see that the way that
I see this?
Dr. Walensky. Thank you, Senator. As you noted, we have 20
percent of Americans, 57 million Americans living in rural
areas. Part of the deep need for investment in a public health
infrastructure is to develop a workforce that looks like the
community, that is from these communities, that knows how to
access and reach these communities, which is exactly one of the
challenges that has that has occurred during this pandemic. And
one of the reasons we had a differential distribution of
vaccines between rural and non-rural communities.
We also know that there are other issues, outside of COVID,
where we have learned from COVID, such as telehealth. We had a
previous MMWR that demonstrated, ironically, that telehealth
was not reaching rural communities. And that is, in fact, one
of the areas that we should be using telehealth. So why was it
not reaching their rural communities? CDC is investigating this
just by virtue of the fact that they have had several MMWRs in
the last 2 weeks examining these issues.
So as part of the public health infrastructure and the
disease agnostic infrastructure that works on labs, that works
on workforce that works on data; we are invested in urban
communities as well as rural communities.
FUNDING FLEXIBILITY
Senator Hyde-Smith. And I think a lot of that is broadband
issues as well, that we have to get addressed. But I understand
the CDC has a highly categorical manner for providing funding
to State health departments, with most funding tightly tied to
specific diseases, or specific purposes. And I am concerned
that restricting CDC money to specified activities prevents
States from being able to address issues that vary from State
to State, because all of them are different, and it makes it
difficult to respond efficiently to emerging challenges like
COVID-19.
And I have always been big on flexibility because the
States really know where their needs are, and I believe greater
flexibility on funding might allow States to better target
resources. So I just wanted to mention that to you, of the need
for flexibility there, that we sure saw that our hands were
tied in some cases during COVID. So I just wanted to address
that with you.
Dr. Walensky. I would just echo your thoughts and say, yes.
That one of the things that has been challenging for us at CDC
is the line items that have to go to X or Y, when in fact what
we need is the infrastructure, the disease agnostic
infrastructure, so that when we see community--this community
needs this, but they may both need to establish a lab, but one
needs broadband and the other needs a genomic sequencer that
we--it is flexible enough to be able to make sure that each of
the communities can scale up for what they need. Absolutely.
Senator Hyde-Smith. Thank you. That is very encouraging.
Thank you.
Dr. Walensky. Thank you.
Senator Murray. Senator Reed.
Senator Reed. Well, thank you, Madam Chairwoman; and thank
you Director for your extraordinary work.
317 IMMUNIZATION PROGRAM
I have been now working and trying to bolster the Section
317 Immunization Program for many years. And as we recognize
this year, because of the pandemic, there has been significant
increases in vaccination funding going out, and building an
infrastructure. But I don't want to take our eyes off the long-
term need for Section 317 programs to sustain improvements that
have been made in terms of routine immunization, which must be
given.
And so will the CDC be requesting an increase in funding
for the 317 Program this year, Madam Director?
Dr. Walensky. I am going to let Dr. Anne Schuchat take that
question.
Dr. Schuchat. I want to thank you for your long-time
support for the immunization needs of the Nation, and the
incredible progress we have been able to make, particularly
among children. COVID, the pandemic, has really highlighted
that we are not where we needed to be with adults. And that was
part of the slow start that we had in terms of getting--you
know, having the scale up of vaccination.
So there is a lot more work to do to catch up for the
vaccines that were not given during the pandemic, in children,
and to strengthen our infrastructure for adults going forward.
And so that work is part of the priorities for the agency.
Senator Reed. Thank you very much.
SUICIDE PREVENTION
Dr. Walensky, this is not the first time I think this
thought has been bridged, but the suicide epidemic has been
startling across the country related to the pandemic, and
perhaps related to other factors, and CDC has released some
startling statistics recently about suicide. And I know that
the CDC has launched some new suicide prevention efforts over
the last couple of years, and let me you to continue to do
that. But I understand only a handful of grant applications
were able to be funded. And one of those that were not funded
was from my State, but we were not alone. And what are you
intending to do with respect to the overall suicide epidemic
and also the more robust funding for prevention?
Dr. Walensky. Thank you, Senator. This is such a
challenging area it was--we had scale-up of mental health
challenges before the pandemic, right? So these were issues
that we really needed to tackle before the pandemic. And we saw
during the pandemic that these have only gotten worse, among
our youth, among our middle aged, we have seen challenges even
since the pandemic began.
So part of our resources that we are requesting are to
scale up these efforts. Again, we need surveillance data. We
need to understand how much this is a challenge. How many
people are presenting to the emergency room. We need toolkits
to deliver to States, to physicians, organizations, so that
they can--they are empowered as to how to prevent it. And then
we need actionable implementation that we can do for prevention
in areas of mental health.
LEAD POISONING PREVENTION
Senator Reed. Thank you. One final topic is lead exposure,
which I have been working on through my responsibilities on the
Banking Committee, and also the Appropriations Subcommittee on
Housing and Urban Development, over the last year rates of
screening for lead poisoning have decreased, obviously, as you
know, movement and these types of activities have been
curtailed. And then I think the statistics, although it would
probably be very dubious coming out of the last year because of
all these other factors, but it is a continuing problem.
And right now the CDC's Lead Poisoning Prevention Program
is at a high mark of $39 million. But we know more funding is
needed, and we also know that this initiative
disproportionately impacts lower-income communities because of
the housing circumstances, generally.
And I would hope that the President's CDC budget will
prioritize this work, keep increasing funding and focus. I
would note, he is going after the lead pipes, which I applaud.
But in many respects, particularly in older communities like
mine, the issue is not lead pipes, it is housing and lead
paint, and it is a whole series of issues.
Dr. Walensky. Thank you. I think this raises a very similar
point, as was previously raised by Senator Hyde-Smith, that
each community needs individual things to improve the health of
their community, which is why the public infrastructure
flexibility, the funding to be able to get the resources that
you need in individual communities.
One will be--you know, we need resources for broadband, but
one will be, we need resources for lead. And as you note we,
again, had an MMWR that demonstrated exactly what you said.
Screening for lead this past year has gone down. We know we
have missed lead toxicity that we really need to make up for.
Senator Reed. Thank you very much.
Thank you, Madam Chairwoman.
Senator Murray. Thank you.
Senator Moran.
Senator Kennedy.
Senator Kennedy. Thank you. Madam Chair.
Madam Director, thank you for being here today; I know how
busy you are. I have been in my office listening to some of the
testimony of both of you. And I am a little uncertain about
some of the answers, which is probably a shortcoming on my
part.
MASK GUIDANCE
Madam Director, could you, in one minute, summarize for me
what the recommendations are today from your agency about
wearing masks?
Dr. Walensky. Absolutely. First of all, can I just say,
thank you for your YouTube video, for promoting vaccines, which
I just adored.
Senator Kennedy. Did you like my singing?
Dr. Walensky. Yes, I did. Thank you very much for doing
that.
Senator Kennedy. You are under oath, now, madam.
[Laughter.]
Dr. Walensky. Yes, I did--even so, I did.
Senator Kennedy. Thank you for that.
Dr. Walensky. Last Thursday, we released guidance that
demonstrated for an individual who is able--who is fully
vaccinated and not immunocompromised, that they are able to
safely unmask with the exceptions--certain exceptions, of
course, in travel corridors, healthcare settings, that if you
are an individual you can safely unmask if you are fully
vaccinated.
Senator Kennedy. Inside and outside?
Dr. Walensky. Inside and outside.
Senator Kennedy. Okay. What role do the State regulations
play with respect to that?
Dr. Walensky. We are working now to update all areas of
guidance, but here is what is really, I think, important to
understand. We are not a homogeneous United States. We have
counties that have less than 20 percent vaccinated.
Senator Kennedy. Yes, ma'am. But I don't want to get too
off, off the question here. If I walk over to the House of
Representatives, do I have to wear a mask?
Dr. Walensky. Those are locally-driven policies, but we
felt that it was important for the science to--for us to convey
the science of what is safe for individuals.
Senator Kennedy. Well, I am trying to understand the CDC
recommendations, and I appreciate it. Based on the CDC
recommendations, if I walk over to the House, are you
recommending I wear a mask?
Dr. Walensky. If you are--if you are by yourself walking
over to the House and you are fully vaccinated?
Senator Kennedy. No, ma'am. Once I am over there. I am
vaccinated. Once I am over there and I am talking to some of my
colleagues?
Dr. Walensky. We have really encouraged that the policies
of mask-wearing be locally driven. And the reason for that is
because every community, every county, has different rates of
disease and different rates of vaccination. And that is really
what----
Senator Kennedy. What is different about the House? Do you
know?
Dr. Walensky. I don't actively--I don't know the rate of
vaccination around the Capitol, nor the rate of disease around
the Capitol off the top of my head.
Senator Kennedy. Okay. What about airplanes?
Dr. Walensky. What is the policy on airplanes? Currently,
the policy on airplanes is to wear a mask.
Senator Kennedy. Okay. And why is it different on an
airplane as opposed to a restaurant?
Dr. Walensky. So the CDC provides guidance for what is safe
to do. The Federal policy is obviously an interagency policy
that we need to look at across different agencies. What I will
say though, is that there is very little choice when you board
an airplane as to----
Senator Kennedy. Right.
Dr. Walensky [continuing]. Who is going to be sitting next
to you, who is around you. And also, airplanes may be a place
where we have more variants, because of the travel from
international places.
VIRUS ORIGINS
Senator Kennedy. Okay; last question. What, in your
opinion, was the origin of the virus?
Dr. Walensky. This has been studied by the WHO----
Senator Kennedy. Ma'am, I am asking your opinion.
Dr. Walensky. I don't believe I have seen enough data,
individual data, for me to be able to comment on that.
Senator Kennedy. What are the possibilities?
Dr. Walensky. Certainly, the possibility is that most
coronaviruses that we know of are of origin from--that have
infected the population, SARS-CoV-1, MERS, generally come from
an animal origin, and----
Senator Kennedy. Are there any other possibilities?
Dr. Walensky. Certainly, a lab-based origin is one
possibility.
Senator Kennedy. Okay. Is the United States funding gain-
of-function research?
Dr. Walensky. Not to my knowledge.
Senator Kennedy. Okay. Can you give an answer to that for
me, and let us know, let the committee know?
Dr. Walensky. Dr. Fauci would be the one who knows best,
and he testified last week----
Senator Kennedy. Dr. Fauci seems confused. I am asking--
with all due respect--I am asking you to get us that
information. Where throughout the world, including, but not
limited to the United States of America, are we doing research
on these viruses to make them contagious in order to study
them? That is what I mean by gain-of-function.
Dr. Walensky. I understand. I understand. We certainly can
have our staff look into this. I don't know that we have access
to labs across the world, just the ones that are funded here in
the U.S.
Senator Kennedy. Yes. But you are the Head of the CDC. I
bet if you--I bet that you get your phone calls returned.
Dr. Walensky. Okay.
Senator Kennedy. Would you get us that information?
Dr. Walensky. I would be happy to give you the information
to the best of my ability.
Senator Kennedy. Okay. And I am going to do long--a
complete album of my singing. I will send you--I will send you
a courtesy----
Dr. Walensky. Would you sign that, please?
Senator Kennedy. Sure. Thank you. Thank you, both, for
being here.
Thank you, Madam Chair.
Senator Murray. Senator Baldwin.
Senator Baldwin. Thank you. Madam Chair.
MASKS IN WORKPLACES
I want to pursue a similar line of questioning that we just
heard from Senator Kennedy, with regard to masking guidance.
And when I reflect from the period of time when the pandemic
was first identified, the Department of Labor and the agency
charged with occupational safety and health, did not issue any
sort of emergency temporary standard with regard to workplaces
relating to this pandemic.
And, frankly, while there has been much work done on that
in this new administration, we don't have one yet, and so I am
just delighted by the progress we are seeing. Generally, I see
that light at the end of the tunnel, getting brighter, and
brighter, and brighter, and certainly the CDC's updated mask
guidance for those who are vaccinated is a reflection of that
progress.
But I am concerned about the impact of this guidance on
workers, and particularly those who work in crowded conditions,
such as meat-packing facilities, where we have seen horrendous
outbreaks in the past year.
So, Dr. Walensky, I am wondering when we can expect perhaps
more detailed guidance for workplaces, such as meat-packing
plants, and other crowded facilities where there is going to be
a mix of vaccinated and unvaccinated workers? And how that is
going to interact with the very recent CDC guidance on mask use
for those who are vaccinated? What should workplaces be doing
right now?
Dr. Walensky. Thank you so much, Senator Baldwin. The meat-
packing situation was really, really difficult, so many, people
affected and lives lost. And a real challenge for the Nation to
react to that.
Updating guidance for workplaces, including the higher-risk
ones is a high priority for us that we are actively working on.
As you know, the initial individual guidance came out last
week, but updating guidance for particular settings is
critical. Our National Institute of Occupational Safety and
Health is working closely with OSHA around getting the best
science to the Department of Labor who has regulatory
authority, but we are at CDC, updating our guidance for the
particular settings in light of the newer science.
Senator Baldwin. I appreciate that.
PUBLIC HEALTH COMMUNICATION
I want to ask a question of you, Dr. Schuchat, about the
importance of communication in public health. Early in the
pandemic, again, we had to get out a lot of information on what
COVID-19 is, how it is spread, what precautions people can
take. And, likewise, now we are in the vaccination phase, and
we have to communicate about its safety, efficacy,
availability, et cetera.
Last year, I wrote the CDC requesting that they provide
information on the spread of COVID-19 in Hmong language. The
CDC later updated their material, which was extremely helpful
for Wisconsin's vibrant Hmong community. But we also need to
make sure that we are doing exactly the same to make
information on the COVID-19 vaccine accessible and available
for all communities.
So, Dr. Schuchat, how is the CDC using what it learned from
sharing information about the spread of COVID-19 to communicate
the importance of getting vaccinated, to those who have limited
English proficiency? And will the CDC be making information on
the COVID-19 vaccine, and how to get vaccinated available in
more languages?
Dr. Schuchat. Yes. Thank you so much for that set of
questions. I think that communication has never been more
important, nor more difficult than the past year, and reaching
people with limited English proficiency has been really
important.
We have a toolkit available in 34 languages, and our
vaccine information, including our V-safe, the little app that
helps people follow side effects after getting vaccinated, is
available in multiple languages. But it is not just what we
say, it is how we say it, and who says it; and so one of our
strategies is working through trusted messengers and partners
of the community, from the community, who work with groups day
in and day out, and so part of our strategy is funding of
jurisdictions for them to have community-based groups really
get that message out in ways that are accessible.
These are really important issues, as we know. You know,
back to the meat-packing outbreaks, we had people speaking
multiple languages in very close quarters at risk for spread,
but also not necessarily knowing who they could trust in what
they should do. So we clearly want to get the vaccine
information to them.
Another thing I would mention is the partnership that CDC
and the administration has had with HRSA (Health Resources and
Services Administration), around the federally-qualified health
programs, because they have--the federally-qualified health
centers have a real concentration of patients served with
limited English proficiency, in both mobile clinics for
vaccination, and through community clinicians--community
vaccination sites. They have been able to reach those groups.
Senator Baldwin. And Senator, if I am might add, just real
briefly. One of the things that would be really helpful for us,
is working with those industries to encourage employers to get
their employees vaccinated, that time off, paid time off, to
ensure that they--when they returned to work they are
vaccinated.
Senator Murray. Thank you, Senator.
Senator Braun.
Senator Braun. Thank you, Madam Chair.
MASK GUIDANCE FOR VACCINATED INDIVIDUALS
Dr. Walensky, I am glad that the recent ruling was made
that if you are vaccinated, you don't need to wear a mask. I
think it was getting very confusing for not only getting more
people vaccinated because they were saying, well, why should I
get vaccinated if I still have to wear a mask? So thank you for
that.
But I do have a question. I know that on March 29, the
President was criticizing some governors about removing mask
mandates. And of course that now has changed. And I think the
reason is what I have just said. But what about, since the
science now, and the guidance is clear, what about local mayors
and governors that are not following the science, when that has
kind of been ballyhooed as the thing to do. I believed in that
from the get-go as well, especially when the tools were very
uncertain, distancing and all that stuff, made sense. And I
thought you were silly not to abide by it.
What about now? For the places that are--I think there is a
liberation feeling out there, and thank goodness for the Warp
Speed, and getting the vaccines in the arms. Is this
unnecessary for governors and mayors across the country to
still keep a mask mandate in place?
Dr. Walensky. Thank you for that question, Senator. We
released guidance on Thursday that said for individuals, if you
are vaccinated, fully vaccinated, you can take off your mask
with several exceptions. One of the things I think that is
really key in this is to recognize that we are not a
homogeneous country.
That there are some areas that--some counties that still
have less than 20 percent of people vaccinated. There are some
counties that still have greater than a hundred cases per
hundred thousand in a seven-day period of time. And so I
actually think, as I look at the map, a very heterogeneous map
of how we are doing with cases, how we are doing with
vaccinations, the decisions about whether to take off a mask
mandate will have to be made at the local level, have to be
made at the community level.
There are still some communities who are suffering. We know
African-Americans lost 2.9 years of life compared to White
Americans losing 0.8 years of life. And they are probably the
communities that got access to vaccines last. We are working on
that. We have had extraordinary improvements in our access to--
in our racial and ethnic minorities having access to vaccines.
But I do think that these need to be made at the local and
community level for exactly that reason.
Senator Braun. Do you think it will be confusing though,
even for those places that have lagged in getting their
citizens vaccinated to see that there is not that incentive in
place, even in the places that have been slower to do it, that
would be an encouragement. If they see people without a mask
and they say, well, they are vaccinated. I want to get one.
Dr. Walensky. I think it would be really amazing if our new
guidance got more people vaccinated, and was an incentive for
more people to get vaccinated. But I don't make CDC guidance,
my whole agency does not make CDC guidance based on what it
will help people do. We have to do it based on the disease that
is out there, the access to vaccines, and based on the science
that has emerged.
I really am hopeful that that will help to incentivize
people to get vaccinated, but that was not the reason for our
guidance.
COVID IN INDIA
Senator Braun. Okay. Another subject, since we are kind of
at least ebbing into a situation, it looks like here in the
U.S., other countries, some places it is still running rampant
like India. When do we turn the focus? And I think we have been
lucky that vaccinations have come this quickly, but
therapeutics would seem to be that final defense for anyone
that did not have a vaccination available. And now for the few
cases that could still slip through the cracks to where it is
impacted with so much data, such a small portion of the
population, disproportionately, and horrifically, elderly
predisposed with other conditions.
COVID THERAPEUTICS
When do we start turning our attention to helping them once
they get it? Because we are going to still have cases,
depending on variants, how strong they are, to where the
emphasis goes to therapeutics, and not vaccinations, especially
for places where the vaccine is generally working, but you
still want to have tools to help those who get it?
Dr. Walensky. Absolutely. And I know--first of all, I think
we are--you know, we are working now, we have said, if anyone
is not safe, then no one is safe. We really do need to make
sure that we have resources to other places, if variants emerge
they will come to our shores. So we have to be able to do that.
I also know that NIH has invested in making sure that we
have therapeutics. One of the first things that we had when I
was rounding on the wards last May, was Remdesivir. And that
was the first sign of an antiviral.
We don't have anything really that we can give quickly over
the--you know, by prescription to outpatients. Right now we are
relying on monoclonal antibodies. They are hard, they are
clumsy, they take a lot of resources, and they are expensive.
And so I do believe that we need, in this next phase, after we
get the majority of Americans vaccinated, we do need to turn to
antivirals that are able to be easily administered in an
outpatient setting.
Senator Braun. And a final comment. I think that is going
to be important because we don't know how much variants will
become an issue. And at some point when we have generally
tamped it down, I think it is incumbent on us to put focus on
how to help those that end up getting it, especially that are
so predisposed with bad outcomes. Thank you.
Dr. Walensky. Thank you.
Senator Murray. Thank you.
Senator Manchin.
Senator Manchin. Okay. Thank you, Madam Chairwoman.
Appreciate it very much. And I want to thank all of you for
being here.
Dr. Schuchat, first of all, thank you for your service,
many, many years of service. And I appreciate very much, what
you have done. And my first question would go to you because
you probably have the historical knowledge of how we got to
where we are.
VULNERABLE PUBLIC HEALTH SYSTEM
Over the last decade, the United States has lost over
50,000 public health jobs. And during that time we have faced
the H1N1 flu outbreak, Ebola, Zika, and now COVID, within the
last 5 years alone, West Virginia has lost nearly 30 percent of
our public health workforce. One thing we know from this
pandemic is that we were not prepared. While we have been able
to hire temporary public health workers in the last year, as
these positions they were not permanent, and are at risk of
disappearing after the public emergency, health emergency is
over.
So can you speak to how we became so vulnerable and fell
behind the curve in our ability to respond to this pandemic,
and how can we keep it from not happening again? I know you
have all touched on it, but I just cannot believe we were
this--we were this unprepared.
Dr. Schuchat. Yes. I think the state of our preparedness
was a real tragedy. And part of that relates to the public
health infrastructure over and over, we invest in response to a
crisis, but in ways that haven't provided sustainable capacity
at that frontline where the problems happen, so----
Senator Manchin. But these decisions made higher up within,
whoever the administration may have been, whether they were
Republican or Democrat. Was it made at that level? Or was it
made at the Head of the CDC?
Dr. Schuchat. The biggest funding increases we have gotten
have been emergency funds from Congress that, you know, happily
supported response for H1N1, and Ebola, and Zika, and COVID.
But the dollars that were there day in and day out to provide
reliable jobs for the local public health workforce were not
there. And whether it was State budgets or Federal budgets
that, you know, you cited the statistics of the job loss.
Beyond that, the jobs were not the same anymore. You know,
we talked about the data. Our data systems have really not kept
up with the times. We have very fragmented data systems that
have not been modernized.
Senator Manchin. And my time--my time is limited, and I
want to ask Dr. Walensky this question.
But on this Dr. Schuchat, what type of time basis would you
say that we should be looking at for funding? I mean, to have
confidence in the funding, permanent funding, over what, a 5-
year, a 10-year period? So it is consistent you know what you
can do and be prepared?
Dr. Schuchat. You know, I think the approach that was taken
for NIH to strengthen their capacity for vital biomedical
research is what needs to happen for the vital public health
infrastructure in the country, where it is not a feast and
famine.
Senator Manchin. Sure.
Dr. Schuchat. But that local, State, and Federals can plan.
Senator Manchin. And now will be the time to do it. If we
are ever going to do it, we should do it now, since it is all
very fresh in what we have been able to endure.
OPIOIDS IN WEST VIRGINIA
Dr. Walensky, as you are aware, we are facing an epidemic
within the pandemic, West Virginia is ground zero for the drug
epidemic, with the highest rate of drug overdose deaths in the
country. To make matters worse, 2020 was the worst year yet
with over 90,000 deaths, and we saw at least 47 percent
increase in the State of West Virginia with overdose deaths. So
what resources is CDC providing to States to combat the
epidemic?
Dr. Walensky. Thank you, Senator, for that question.
Senator Manchin. And also, I would have made--and the
second part of that would be: in working on helping--what CDC
is--are working on helping increasing the testing for viral
hepatitis and HIV? We have had a tremendous--horrendous
situation with that.
Dr. Walensky. I can tell you, just before coming here, I
spoke to one of my infectious disease colleagues in West
Virginia, and she was telling me that they have opened neonatal
detox units, I understand, that it is unbelievable.
Senator Manchin. Unbelievable, unbelievable.
Dr. Walensky. It is unbelievable. And so we know that we
need to tackle this. We need to counter this. We need accurate
data. We need interventions that can--and we need resources to
be able to invest in Opioid Naloxone Programs that are reaching
the community. Community health workers that can do the
outreach to talk to people and intervene at the local level
where these are happening, we need toolkits, we need
information, and mental health support services to intervene.
AMERICAN MEDICAL MANUFACTURING
Senator Manchin. Right. My time is running out. I want to
ask you that one other thing that--we produce very little of
the things that we basically needed for medicine, penicillin,
do you think penicillin should be produced in America? Do you
think doxycycline should be produced, an antibiotic in America?
And if so, what should we do in order to do that? Or stockpile
strategically for our own protection?
Dr. Walensky. I think we need to have a public health
infrastructure and a pipeline that allows us to respond to
pandemics, and to epidemics, and to infectious threats.
Senator Manchin. Do we have any manufacturers that are
producing these in America?
Dr. Walensky. There are limited manufacturers producing
penicillin, that I can talk to. Because, in fact, we have had
penicillin shortages, penicillin has gotten extraordinarily
expensive. And in fact, some colleagues of mine have once said,
it should be cheaper than the pipe--than the tubing it runs
through. And in fact, it is not.
Senator Manchin. Should the CDC basically--I mean, your
recommendation would be for production. We should be producing
these in America. You know, we need to have something from a
professional, like yourself, to get back to producing things in
American, and not depending on supply chains.
Dr. Walensky. So one of the things I can just mention for
penicillin specifically, is it is particularly hard given the
allergies related to penicillin. It is actually, particularly
hard to do. There are limited plants that make penicillin. But
your point is well taken.
Senator Manchin. Thank you.
Thank you, Madam Chair.
Senator Murray. Thank you.
Senator Moran.
Senator Moran. Chairwoman, thank you. Thank you and Senator
Blunt for this hearing. And welcome to our two Doctors, thank
you for service.
COLLABORATION ON BIODEFENSE FACILITIES
I have four questions I am going to try to accomplish in 5
minutes. Let me first highlight something that is occurring in
my home State. Kansas will soon be the home to the National Bio
and Agro-Defense Facility. It is a $1.25 billion research
facility, nearing completion. Its mission is to--or the
facility is to protect U.S. livestock from foreign animal
diseases, including zoonotic diseases that can pose significant
threats to human health. NBAF (National Bio and Agro-Defense
Facility) will be the first bio containment facility in the
U.S. where there is a BSL4 laboratory, which zoonotic pathogens
for which there no treatments, currently, exist.
NBAF is operated by the U.S. Department of Agriculture with
cooperation from the Department of Homeland Security, right, so
truly going to be as a state-of-the-art facility, COVID-19,
which possibly is a zoonotic disease, has only highlighted the
importance for the U.S. to invest in this type of research.
Are you engaged with USDA (U.S. Department of Agriculture)
or Homeland Security on future research that could be conducted
at NBAF in regard to the zoonotic diseases? What kind of
research NBAF would be able to provide you with benefits in
your mission of protecting human life?
Dr. Schuchat. Let me just say that what we call One Health,
the idea of human and animal health, and the environment has
been a global issue for preparedness and response. We have seen
so many terrible diseases emerge from the animals, and we have
not been sufficiently ready for them.
Whether we are dealing with the genetic sequencing of
strains, and whether the animals' strains have adapted better
to humans, or research into containment interventions, it is
really important. And so our principle of collaboration between
Health and Human Services, and the Department of Agriculture,
and Department of Homeland Security is very important.
I can say that the CDC and USDA both have oversight over
select agents that, you know, are evaluated in those BSL4
facilities. And we work very closely with them to make sure
that animal health is protected, and that human health is
protected, and laboratories that are sending these pathogens do
so safely without risk to the surrounding community.
As to exactly where we are with collaboration, I think we
will have to get back to you, but it's a--congratulations on
the facility. And I think we will look forward to working
together.
Senator Moran. This is a post\1/1\1 development, and
designed to replace the Plum Island and the research done there
on a new advanced laboratory. I would welcome the opportunity
to connect you and the folks at either Agriculture or--and
those in Kansas as well.
INTERNATIONAL COLLABORATION
What, if anything, is steps that CDC, or perhaps broader,
the Federal Government should do to bring China into this world
of helping us combat diseases, the spread of viruses? Is there
any opportunity for us to get better information, in any way
that we can insist, encourage or demand that China behave
differently than what they did, after the arrival of this--the
evidence of this disease in China?
Dr. Walensky. I think that we are all a global community at
this point, and that when there is a threat anywhere, there is
a threat everywhere. And so when it comes to our health, when
it comes to science, it is helpful to have these connections we
have in office, our regional office in China, where we exchange
scientific information. So I think around the global community,
it is important that we--that we convey scientific inference.
Senator Moran. What is your evaluation of what cooperation
occurred between China and the United States in regard to
COVID-19? And has anything changed to increase or decrease that
cooperation now?
Dr. Walensky. The WHO (World Health Organisation) has done
a study--has numerous interactions to evaluate this. My
understanding is that there is another phase of that study
underway. And I think that that is really critically important,
because quite honestly, and in my review of that study, and
many have spent many hours reviewing this study--these studies,
there was not a lot of transparency in line-level data that is
able--that we are able to use to interpret.
Senator Moran. Dr. Walensky, there is probably a longer
answer than that. And maybe we can have that when you and I
have a chance to have a conversation.
A couple of things in the 30 seconds I have left. I would
highlight that you and I have had this conversation, Dr.
Frieden encouraged me in regard to the Global Health Security
Program, and I have tried to be an advocate for that program in
this appropriations subcommittee, with some success.
And I just would--I am interested now, you don't have to
answer this question in the lack of time that I have for you to
do so, but I would love an answer that tells me how I should
prioritize. You have said it, what happens elsewhere matters to
us, and absolutely the truth and we have known that for a long
time, but how do we prioritize now with the consequences of
this pandemic in the United States?
How do we prioritize the appropriations that will go to
programs that are outside the United States, that are
protecting us as well as citizens of the world, as compared to
things that need to be done domestically, which are
significant? So I would love to have a broader discussion about
where those priorities should lie.
LEARNING LESSONS FROM COVID
And finally, I would indicate, I am reading a book, which I
do regularly, The Premonition, and I don't know whether you
have read it, but I am two-thirds the way through. It is not
terribly derogatory, but not terribly complimentary of the CDC.
And I would welcome any suggestions you have of what the
takeaway should be for the CDC, or if it is a book that is
worthy of learning something from.
Dr. Walensky. Thank you, Senator. I would be happy to
engage in those conversations. I have not read The Premonition,
although I know of it, and I know many people who are in it.
And what I will say is, there are many lessons that we can
learn, some things that we have to do better at the CDC, and
some things that we have to do better as a country, and
investing in multiyear public health infrastructure.
I think among the comments in the book that I am familiar
with was one of the issues that I heard firsthand, you know,
labs receiving results by fax and, you know, people working in
data entry to do that. That is not a public health
infrastructure of the future. It is not a way to respond to a
pandemic.
And so I think the lessons to be learned from the book, are
yes, we have to understand where things could have gone better
at CDC, and we need multi-year infrastructure resources to make
sure that we have, you know, work force, and data, and labs up
to snuff to tackle whatever they need to tackle in the future.
Senator Moran. It seems well written to me, and by a
credible author. And I would encourage you to learn from it, as
I am trying to.
Madam Chairwoman, the last comment I would make is. One of
the things, my takeaway is the failure for CDC to authorize
testing early on in circumstances in which it appears to me,
testing should have been occurring.
Senator Murray. Thank you.
Senator Shaheen.
Senator Shaheen. Thank you, Madam Chairman. And thank you,
Dr. Walensky, and Dr. Schuchat, for your service to the
country, and for being here this morning.
OPIOIDS IN NEW HAMPSHIRE
Dr. Walensky, I very much appreciated our conversation
earlier this week. And one of the things we talked about is the
continuing challenge of the opioid epidemic that we are facing
in this country. New Hampshire, like West Virginia, has been
very hard hit. We are one of the 10 States in the country that
has been hardest hit by the epidemic.
And I was pleased that Congress provided some new
flexibility to deal with the epidemic last year, by including
meth and cocaine as part of the drugs that could be included in
programs to address opioid--the opioid epidemic. But can you
talk--one of the things we discussed was the challenge that I
have heard from providers in New Hampshire that we don't have a
response for those overdosing on meth in the same way that we
have Narcan for those who have overdosed on opioids.
Can you talk about what the CDC is doing to approach this
issue and what kind of help you might have available for States
like New Hampshire?
COMMUNITY HEALTH WORKERS
Dr. Walensky. Thank you, Senator. You know, I am thinking
back to, sort of, 6 months ago and what we needed to do when we
knew that one of our patients had relapsed, and how we get them
into care. And it was our community health workers that knew
where to find them. They knew where they were getting their
drugs, and they knew where to find them, and to say, somebody
cares for you, and brought them back.
And that, I think, is what we need in our public health
infrastructure. We need the community workers who live in the
community, who are from the community to make those
interventions, to find the people. And that is really among the
things that I think this public health infrastructure is going
to be able to do. Certainly, we don't have something like
Naloxone for meth overdose and that, you know, is unfortunate
right now, and we need to address that.
And then quite honestly, we have statistics of the
overdoses and the lethal overdoses. They are terrible. And yet
we also have statistics of, you know, all these
hospitalizations that are happening among young people that I
was taking care of just 6 months ago, 30-year-olds getting
their second valve replacement.
So this is something that we have to tackle, and it is not
just that we have to tackle it with Narcan in a given
community. We have to tackle it community by community, because
there are all different kinds of communities, and we need the
workers to be able to do so.
Senator Shaheen. Well, thank you. I hope that--and I know
this is not a CDC issue--but I hope that you will weigh in, if
you have the opportunity, with the administration on the
importance of the set-aside funding for States like New
Hampshire that have been hardest hit, because that has allowed
us to up a real statewide response to the epidemic.
PFAS CONTAMINATION
I want to go on to PFAS, which is an emerging contaminant
until we get the EPA (Environmental Protection Agency) to
designate it as something else. But it is one that we have seen
very directly in New Hampshire, and especially appreciate the
response from the Agency for Toxic Substances and Disease
Registry, which has been so helpful in undertaking a
comprehensive health study in New Hampshire, Portsmouth, and
Pease former Air Force base, have been one of the sites
designated.
But one of the things we have learned is that too many of
our members of the medical community don't have any idea about
PFAS. They don't know what it is. They don't know how to
respond to it. They don't know whether testing is appropriate
or not.
And I worked with Chairman Murray and Ranking Member Blunt
last year to fund a grant program to help educate our
physicians. And I am very interested in how that unfolds, and
the work that the CDC might be doing to help an ATSDR (Agency
for Toxic Substances and Disease Registry) to educate our
medical community.
So I don't know if either of you can speak to that on the
update on where that effort stands.
Dr. Schuchat. This has been such a complex and challenging
area, and I really appreciate the leadership that you have
shown, and the----
Senator Shaheen. Thank you.
Dr. Schuchat [continuing]. Support you have given, and also
the advocacy for us to learn what we need to learn so that
people who have been exposed, and the clinicians that they see
know what to do to get a result, and then not know what it
means and what you are supposed to do about it is challenging.
So we really are incredibly grateful for the resources that are
letting us begin to pave the way to get those answers.
I don't have specifics on the results of studies yet, but I
know it is a very high priority for ATSDR and the leadership
here.
Senator Shaheen. And do you know that, at one point in the
last year, there was a suggestion that there was a connection
between exposure to PFAS and severity of COVID-19. Do we have
any more information about that?
Dr. Schuchat. You know, I know that question came up and
that we were looking into it. I don't believe we have a final.
But we can get back to you if we do.
Senator Shaheen. That would be great. Thank you. If you
could just let me know, either way, what we know about that, I
would appreciate it. Thank you.
Thank you, Madam Chair.
Senator Murray. Senator Capito.
Senator Capito. Thank you, Madam Chair. And thank you for
our witnesses today. Both of, Dr. Walensky and Dr. Schuchat,
and I wish you the best in your--we won't call it retirement--
in your repurposing. How about that? Wherever you may land?
Let me ask specifically. Senator Shaheen and Senator
Manchin mentioned, obviously, the overdose rates in the State
of West Virginia, so I won't go back through that. But I am
concerned.
HIV IN WEST VIRGINIA
Dr. Walensky, I know you have a focus on ending the HIV
epidemic. I know this is in your academic career as well. You
mentioned it in the President's budget. West Virginia received
a grant in the Integrated Viral Health--or Hepatitis, excuse
me, Surveillance targeted funds to help us address certain
areas, hotspots, I guess you would call them. But we are not--
we are not in ending HIV epidemic focused jurisdiction, nor any
of our counties. And in your testimony, you state that
increased funding in the budget is for four key strategies in
the focus areas, but not to increase the amount of focus areas.
So my question is, I think we need to be a focus area
because we have some of the highest incidence. And how do you
expand that footprint? Or, how can you help me with that?
Dr. Walensky. Thank you, Senator. As I think you noted, my
20-year career prior to January 20 was in doing exactly that.
And I was really encouraged by ending the--the mission to end
the HIV epidemic, really through a diagnosis, prevention,
treatment and response. And, you know, when the initial tranche
of HIV and the HIV epidemic money went out, it was to areas
with the highest numbers, with truly a multi-year plan to
expand to other areas that we needed to really curb things in
the areas with the highest numbers.
Take some of the lessons that we learned and expand to some
of the other areas. And so I have a vision, and hope that we
will be able to do that in the--in the years ahead, and to
continue that expansion.
Senator Capito. Thank you. Thank you. So expansion into
areas such as ours, I think that would be welcome. I would make
note that in the initial disbursement of the vaccine, our State
of West Virginia did an incredible job working with our public
health infrastructure. But I think one of the lessons that we
learned, and that I hope this becomes part of a manual to
address future issues, is public health infrastructure cannot
do this by themselves, not to what we saw at the--the breadth
of what we saw.
So what happened? We had volunteers, we had county city
governments, and we had our National Guard. And so I would
encourage you while, I think, increasing our public health
infrastructure is absolutely essential. I think growing those
partnerships could be even more essential because there is a
roadmap there to success. And so I just put that on your radar
screen, as you are--as you are looking to expand.
MASK POLICY JURISDICTION
One thing I would like to ask, and Senator Blunt and I were
in the Oval Office when the announcement was made with the
President that we were going to lift the mask mandate. And I
cannot tell you how joyful we all were as we ripped our masks
off and had a great meeting after that.
But there is confusion still. And, you know, if we are
going to get more people vaccinated, which is the ultimate goal
all the way down through the age levels, we cannot have this
confusion, because it is just: should I get my child
vaccinated? You know, should I--how old can my child be to get
vaccinated?
Does my child need to wear a mask at school? Who is the
ultimate decider here? Is that the CDC? Is it the President? Is
the governor? Is it the NIH? I mean, there is just too much
coming at young families in particular, I think, to be able to
feel, number one; that their child is safe, and they are doing
the right thing for them to go to school. But also to get rid
of that, I would say not anti-vaxxer, but vaccine hesitation. I
think that is a large part of the people that are left as yet
to be vaccinated. So how would you respond to that question?
Dr. Walensky. Thank you. The guidance that we put out on
Thursday was individual guidance for people who are fully
vaccinated can take off their masks.
Senator Capito. Right. Right.
COVID-19 VACCINES FOR CHILDREN AND ADOLESCENTS
Dr. Walensky. I have--or I was pleased actually the day
before that the FDA (Food and Drug Administration) had
authorized and the CDC had recommended vaccination with Pfizer
vaccine for individuals as young as 12 years old, that is now
recommended. And my 16-year-old has been vaccinated, and we
have a lot of community workers out there encouraging
vaccination of youth.
And, in fact, over 600,000 people between the ages of 12
and 15 have been vaccinated just in this last week. In terms of
guidance, the CDC provides science-based, evidence-based
guidance to anybody who is the consumer of said guidance,
whether it be industries, jurisdictions, importantly the
country is not uniform. And so I think you really do need to
interpret our guidance in the context of what is happening in
your community. And that is really important in the context of
a transmissible agent.
Why is that important? Because the virus is going to be an
opportunist, if you have a county that has low vaccination
rates and high rates of disease, that county may interpret our
guidance differently than a county that has high vaccination
rates, and low incidence of disease.
So we really do have to do this at the local level because,
in fact, the virus will--where there is less vaccination, the
virus will emerge.
Senator Capito. So what do you say to the under-12
population, elementary school? The parents of those children
who have low vaccination rates, which is probably close to
nothing, they have low incident of infection and, you know, all
the studies that show the younger generation is not as affected
as older and even more senior. What do you--what do you tell
them? Listen to your governor? Listen to your school Board?
Dr. Walensky. So what we would say is, vaccines are coming
for youth. We are hopeful to have, they are doing dose de-
escalation studies now down to 9 years old, soon thereafter
down to six, soon thereafter down to three, and then down to 6
months. So we are working towards getting a vaccine that will
be available for all people.
Senator Capito. So when would that be?
Dr. Walensky. Well, some of it depends on how much disease
is out there in the community. So we cannot exactly predict,
but we are hoping to have more available in late fall, and by
the end of the year but through dose de-escalation studies.
And then of course, I think that the guidance that we have
had for schools has actually demonstrated that even in the
absence of vaccinations schools can be a very safe place, given
the guidance that we have. We have recommended that schools not
change anything for this school year, because it will be hard
for our youth to get fully vaccinated before the end of this
school year. We will be updating that soon. And then given that
guidance it will be--there will be policies at the local and
jurisdictional levels.
Senator Capito. Well, I still think it--I mean, I know you
probably would agree that it is a bit confusing to folks all
around the country who have children in school. I would just--
just be as clear, and concise, and definitive, when this
science comes forward and more vaccinations come forward,
because I think it really is--it is really difficult, I think,
for parents to decide how to do the right thing. Thank you.
Senator Murray. Thank you. That ends our first round of
questions. And I will start a second round for any Senators who
wish to ask additional questions.
RACIAL AND ETHNIC DISPARITIES
And Dr. Walensky, I will begin with you. You know, the
pandemics deadly impact on communities of color show we do have
a long way to go to address systemic racism and health
inequities. Black and Latino populations are receiving
vaccinations at disproportionally low rates, even as some of
our recent polls suggest both groups are more likely than White
people to say they want to get vaccinated.
And according to the CDC website data on race and ethnicity
is available for just over half of vaccinated people. How is
CDC working to improve vaccination access and collect more data
on these demographic issues that we need to see in front of us?
Dr. Walensky. Thank you very much for that question,
because we are working hard. We have placed our community
vaccination centers, or mass vaccination centers in areas that
have high Social Vulnerability Index, they are doing an
extraordinarily good job in getting our minority communities.
Our Federal Retail Pharmacy Program sites were selected
initially, in collaboration with the State, to see how we could
get vaccine to the most vulnerable communities, to Black and
Brown communities. And just this last 2 weeks, Federal Retail
Pharmacy Programs, 47 percent of vaccines that they delivered
were to minority communities.
And then our federally-qualified healthcare centers, in
collaboration with HRSA, we have been delivering to people who
are migrant workers, to people in rural communities, and people
who have less access. One of the things we have been able to do
to improve our race and ethnicity data, and this has been
challenging because some people are electing not to report it,
is to use HIPAA (Health Insurance Portability and
Accountability Act)-compliant electronic case reporting, so
that we can use cases--or this is on the case level, not the
vaccine level, but looking at cases and then match it medical
records via Cerner, via Epic, to be able to get case-level
data.
We are working really hard with the counties to get both
racial and ethnic minority data at the case and disease level,
but then also the vaccination level. And this is, again, one of
the areas where data has--you know, our data infrastructure has
not been robust enough to deliver this to us in real time.
Senator Murray. Are you seeing any political ideology plan
to this decision to get vaccinated?
VACCINE HESITANCY
Dr. Walensky. This is a personal choice. I think once we
start saying: this group wants vaccine, this group doesn't,
then we start telling the wrong message. When I was taking care
of patients with HIV, and I was told--the new patient I had to
deliver a new diagnosis. They always said to me, you deliver
the diagnosis and then you pause, and you see what means to
them, right?
Could it mean that they are worried about their baby, they
are going to lose their job, they think they are going to die,
they can't afford their meds? I think vaccines hesitancy is
exactly this.
What is it about the vaccine that is making you hesitant?
Is it that you are scared? Do you have to take the day off of
work to get it? Is it that you saw a friend get it and they had
a reaction? Is it that, wow, how did the science come so fast?
And so this is not about politics, this is about
understanding where individuals are, meeting them where they
are, and understanding what it is that is making them--making
them hesitant.
Senator Murray. Okay. Thank you.
VACCINES IN PREGNANCY
Dr. Schuchat, recent research on the impact COVID-19
infection has on pregnant women is really alarming. One study
last month showed pregnant women with COVID-19 are 22 times
more likely to die compared to women who are not pregnant who
contract the virus. What is the latest vaccine guidance for
pregnant women?
Dr. Schuchat. Yes. Thanks so much for that issue. COVID
complicates pregnancy, so women who are pregnant and get COVID
have worse experiences with the infection, than do non-pregnant
women. More time in the intensive care unit, more risk of
severe outcomes, including those rare deaths. COVID also
complicates pregnancy by increasing the risk of prematurity,
and leading to other types of complications.
While, as you know, clinical trials rarely enroll pregnant
women, we are fortunate that there has been intense effort to
get data about women who do get vaccinated while pregnant, to
understand what happens, so that other women can learn from
that.
Based on what we know right now, we recommend that women be
offered vaccines during pregnancy, that they are eligible to
get them, and that they make a choice about it; that choice
might be based on how they value that risk or that unknown. But
we do have reassuring data right now about vaccines given,
particularly in the third trimester that have been followed and
reported. We are continuing to follow and working closely with
FDA on that. And so we will be expecting this summer to have
even more data, particularly about vaccines given earlier in
pregnancy.
Senator Murray. Is there any research about pregnant or
lactating women who are vaccinated--who are vaccinated,
transferring antibodies to their infants?
Dr. Schuchat. We have emerging data that the antibody is
transferred. And so we hope it will be like the influenza,
where, getting vaccinated during pregnancy against influenza is
really important because newborns and young children are very
high risk for influenza complications. So, good news so far,
and continuing to follow that.
Senator Murray. Thank you.
Senator Blunt.
Senator Blunt. Thank you, Chair.
VACCINE BOOSTERS
The issue of a booster vaccine obviously is out there, so
far most of the people that have said they think we are going
to need it are from the companies that are making the vaccine.
Dr. Fauci, former CDC Director Tom Frieden, others have said
there is growing evidence that there will be enduring
protection with the vaccine we have.
Now, I have been a big supporter of the Warp Speed effort
to invest early in vaccines that were not approved yet, which I
think made a big difference in availability. I do question the
BARDA (Biomedical Advanced Research and Development Authority)
decision to purchase 400 million doses of Moderna and Pfizer as
a booster dose.
Were you asked about whether that was the right decision to
make or not? And if you weren't, should CDC be involved in a
$7.9 billion decision about a booster before we know whether we
need one or not?
Dr. Walensky. Thank you, Senator. I think the first thing
to recognize, and this has been miscommunicated, so I think it
is very important, in the media, is that if you have received
two doses of your Pfizer and Moderna vaccine, you are right now
protected.
Senator Blunt. Right.
Dr. Walensky. What we are looking at is whether we will
need boosters over time. And I think that this is really--given
how hard we were hit by this pandemic, I think it is really
important to understand where we will be with that. Data
suggest from SARS, not SARS-CoV-2, but from SARS, that is
similar to coronavirus, that people have waning immunity over
time.
And if you looked at what happened in the SARS outbreak
several years ago, you saw that people were eligible for
reinfection. So there is biologic plausibility that there would
be waning immunity after you were infected. And we just don't
know when that will be.
One of the concerns has been that if we first vaccinated
our very most vulnerable, our people in nursing homes, that
they may not have had as robust a response, and that they might
be the first to--they would be a first who would need a booster
anyway, because they were vaccinated first. But in fact that
they may not have had a robust response is in----
Senator Blunt. If we spend $7.9 billion, which I guess we
did decide to do on May the 2nd, do we think those vaccines
last for some time?
Dr. Walensky. I am not under the impression those are being
made right now. I think part of the issue is what do they need
to look like? Are we going to boost with the exact same mRNA
structure as we do now? Or might we want to boost with a
variant structure? And I think those are all conversations that
are happening.
Senator Blunt. Yes. Well, I think that is a pretty big
spending decision to make based on the information we have. But
we can talk about that more, later. If we do go forward with
booster vaccines, are you all working to see if in an adult
immunization program, we would try to combine more things with
that booster? A flu shot, or whatever other shot that an adult
might need at this point?
Dr. Walensky. I think it is pretty clear that we have had
an immunization program for adults that was not prepared for
what we needed in this, in this structure.
Senator Blunt. Right.
Dr. Walensky. And yes, I think it would be advantageous.
Currently, we don't have data as to whether you can co-
administer vaccines, those data we are looking for. And in
fact, the ACIP (Advisory Committee on Immunization Practices)
just opined on this last week, because we are so behind on
childhood immunizations, 11 million behind on childhood
immunizations. So those are all the data that we are looking
for, because I think it would be really great to be able to
leverage what we are doing for COVID for influenza as well, and
vice versa.
DATA MODERNIZATION
Senator Blunt. Exactly. And I hope you will keep us posted
on that as that happens. On data, that was actually where I was
going next. You know, the data, we obviously had a data
shortage, a shortage and some confusion about what data to
input, which was not as helpful as it might have been.
Now, the committee, in what was then a fairly controversial
decision, even among our colleagues, we decided, before COVID,
to invest $50 million in base funding over the last 2 years for
data. When COVID occurred, you know, and the numbers we were
suddenly looking at and dealing with, we did another $500
million.
Dr. Schuchat, tell me where you think we are on better data
preparation in the future? Or being better ready in the future
to have data, and the tracking that comes with data? Where are
we, and where would you think--that had CDC in the next fiscal
year, for instance?
Dr. Schuchat. This is essential. The $50 million base
appropriations were vital, but you saw how behind we were. This
is critical. We are so far behind, even with the increased
resources. This is a long-term need; we are better, but we are
not where we need to be. We have made huge progress this past
year with electronic lab reporting of enormous numbers in terms
of how many people were being tested, and getting us daily
data. But the data were not necessarily complete, and as you
heard the race/ethnicity data often missing.
We have a need to move to the cloud for many of our
systems. We have a need to become--have a workforce that can
handle the data at the local level, at the State level, that
can use these sophisticated tools and not just react, but
predict. So we still have a long way to go, but COVID, we have
made a lot of progress on. We need to make that progress across
the spectrum of public health issues.
Senator Blunt. Well data, and tracking, and other things I
think are an important part of the future of health. And we
want to be helpful. And I would hope that the $550 million,
collectively, in the last couple of years has made a
substantial difference in where we are headed.
Thank you, Chair.
Senator Murray. Senator Blunt. Thank you.
I have one additional question for you. The CDC faced
unexpected difficulties, as we all remember during those
opening phases of the pandemic, especially around testing, and
delays in establishing a large-scale testing, likely allowed
the virus to spread undetected, as we know, one of the several
factors that really hampered our efforts to contain that
outbreak.
EARLIEST COVID LESSONS
Dr. Walensky, I just wanted to ask you today, what lessons
has CDC learned from the experience in those first few weeks?
Dr. Walensky. There has been a lot of research going into
what we could have done better during that period of time. My
responsibility is to own that and to make sure that we are
better. Among the challenges were quality--assurance quality
control programs that were not in place the way they should
have been. And in fact, among the things that we are doing is
to ensure that all labs, research and diagnostic labs are fully
accredited.
So we are learning those lessons. Those were hard lessons
to learn. I do also think that we need to recognize that among
CDC's responsibilities is that when we have a new infectious
pathogen, we are responsible for creating the diagnostics for
that pathogen. Once we have done so, we need interagency
collaboration with ASPER, with FDA to make--with the private
sector to ensure that we can bring it to scale.
We are now at 1.1--we did one million tests yesterday, we
are testing one to two million a day. That scale up has to be
interagency. And so, yes, we have a lot of lessons that we can
learn from what occurred, and we are learning them and taking
resources that have been provided to us so that we can, not
just take a line--a line item and improve X-lab, but we can
improve all of the labs and through this accreditation process,
for example, but then also to be able to scale at the national
level.
Senator Murray. Okay. Thank you. Thank you very much. That
will end our hearing today.
But I do want to thank both Director Walensky, and
Principal Deputy Director Schuchat for joining us.
Thank you to all of our colleagues on the committee who
participated as well.
ADDITIONAL COMMITTEE QUESTIONS
For any Senators who wish to ask additional questions,
questions for the record will be due one week after the
President's budget is delivered at 5:00 p.m. The hearing record
will also remain open until then for members who wish to submit
additional material for the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted to Dr. Rochelle Walensky
Questions Submitted by Senator Patty Murray
Question. Researchers in the United States continue to discover new
variants of the coronavirus that are spreading throughout the country.
Congress provided $1.75 billion in the American Rescue Plan for CDC to
increase genomic sequencing of SARS-CoV2 to identify emerging variants.
President Biden's fiscal year 2022 budget proposal includes $8.7
billion for the CDC, a $1.6 billion increase from fiscal year 2021's
budget.
How will the CDC's budget be used to help state and local public
health offices expand their surveillance capabilities to keep pace with
new and emerging variants?
Answer. In May 2021, CDC awarded $240 million in American Rescue
Plan (ARP) funds to state and local health jurisdictions to build
sequencing and analytic capacity for all pathogens of interest,
including SARS-CoV-2. CDC plans to fund these state and local labs for
additional years, with ARP funds, to continue and to build on these
activities, including funding support for equipment, supplies, and
staffing. These activities build on expertise gained through the
Advanced Molecular Detection (AMD) program. In addition, CDC is
currently soliciting proposals for construction and renovation costs
necessary to modernize the sequencing units of the nation's public
health labs, which will also be funded through ARP funds. All of these
labs are currently sequencing bacterial foodborne pathogens, and at
last count, more than 60 labs were sequencing SARS-CoV-2. A subset of
these labs are sequencing other pathogens, such as antimicrobial-
resistant bacteria and fungi, influenza virus, and the agents of
tuberculosis and Legionnaire's disease. The number of labs sequencing
these pathogens, as well as the number of pathogens they are
sequencing, is expected to increase with the availability of these
funds. CDC is also providing technical assistance, as well as support
in planning and administration.
Question. How long will it take to revitalize all state and local
jurisdictions so they are equally equipped to help stop the spread of
COVID-19 and other future disease outbreaks?
Answer. All state public health laboratories, and an increasing
number of county/local public health laboratories, have the potential
to perform next-generation sequencing. At the beginning of the
pandemic, the main limiting factors were (1) limited staffing; (2) the
large number of competing priorities in responding to the pandemic; (3)
a lack of bioinformatics capacity; and (4) limited experience and
knowledge among epidemiologic staff in how to use genomic data as part
of the response. With the long-term investments to strengthen public
health infrastructure as proposed in the fiscal year 2022 Budget,
including public health laboratories, we will be in a better position
to respond and control future outbreaks. With experience from COVID-19,
these organizations are already in a better position to apply genomic
epidemiology during the next public health emergency. But over the next
three to 5 years, with both the investments above as well as
investments in the sequencing Centers of Excellence (also supported by
the ARP funds) and large increases in training, state and local
jurisdictions will be in a much better position to apply genomics to
intervene at the start of a public health emergency.
Question. Thus far, the available COVID-19 vaccines protect against
most of the variants currently circulating. A group of biostatisticians
at Fred Hutchinson Cancer Research Center, based in Seattle, WA, are
studying breakthrough infections of COVID-19 following full vaccination
to determine which variants are able to evade the body's immune
response. By understanding the correlation between needed level of
protection and infection prevention, they hope to simplify the process
of booster shots or vaccines against new variants.
What other research or studies would the CDC conduct to make sure
the United States can quickly and proactively protect people from new,
and potentially more dangerous, variants?
Answer. CDC has monitored for variant viruses since the beginning
of the pandemic and continues to monitor for variants nationwide, in
support of ongoing efforts by the SARS-CoV-2 Interagency Group. We use
genomic information in combination with hospitalization and other case
and outcomes data to identify the spread of, and potential consequences
of, variants of concern.
CDC leads the National SARS-CoV-2 Strain Surveillance (NS3)
program, which identifies new and emerging SARS-CoV-2 variants to
determine implications for COVID-19 diagnostics, treatments, and
vaccines authorized for use in the United States. Genomic sequencing
allows scientists to identify SARS-CoV-2 and monitor how it changes
over time into new variants, understand how these changes affect the
characteristics of the virus, and use this information to better
understand how it might impact health. A notable strength of NS3 is the
regular collection of specimens from across the United States to
support variant characterization efforts, which provides important data
to inform public health decision-making.
Since January 2021, CDC has significantly increased domestic
genomic surveillance platforms to monitor circulating viruses. NS3 was
scaled up to process 750 specimens per week from public health
laboratories across the U.S. CDC also is contracting with large
commercial diagnostic laboratories to sequence samples. CDC has
commitments from these laboratories to sequence more than 20,000
samples per week, pending the availability of SARS-CoV-2 positive
specimens, with the capacity to scale up in response to the nation's
needs.
Since 2014, CDC's Advanced Molecular Detection Program has been
integrating next-generation sequencing and bioinformatics capabilities
into the U.S. public health system. Many state and local health
departments have been applying these resources as part of their
response to COVID-19. Public health departments support local
investigations, conduct studies, and make genomic data available to
public databases. To further support these efforts, on December 18,
2020, CDC released $15 million from COVID supplemental funds through
the Epidemiology and Laboratory Capacity Program.
In May 2021, CDC made available $240 million in American Rescue
Plan funds to state and local health jurisdictions through the
Epidemiology and Laboratory Capacity for Prevention and Control of
Emerging Infectious Diseases (ELC) cooperative agreement. These funds
are to be used over 3 years to build sequencing and analytic capacity
for all pathogens of interest, including SARS-CoV-2. In addition, CDC
plans to fund these state and local labs for at least an additional 3
years, with ARP funds, to continue and to build on these activities,
including funding support for equipment, supplies, and staffing. These
activities build on expertise gained by the Advanced Molecular
Detection (AMD) program since 2014 in the application of pathogen
genomics to public health.
Furthermore, we have issued 29 awards, totaling approximately $37
million, as part of the SARS-CoV-2 Sequencing for Public Health
Emergency Response, Epidemiology, and Surveillance (SPHERES)
Initiative. These awards are intended to fill knowledge gaps and
promote innovation in the U.S. response to the COVID-19 pandemic and
will help integrate next-generation genomic sequencing technologies
with bioinformatics and epidemiology expertise across the US public
health system.
As CDC and our public health partners sequence more SARS-CoV-2
genomes, we will continually improve our understanding of which
variants are circulating in the US, how quickly variants emerge, and
which variants are of most concern to public health, and thus the most
important to characterize and track.
Question. Is the CDC continuing to monitor other public health
concerns such as influenza?
Answer. Yes, CDC has continued to maintain and strengthen its
surveillance systems during the COVID-19 pandemic. For example, in
preparation for the 2021-2022 influenza season, CDC made several
enhancements to influenza surveillance systems, which improve detection
of influenza circulation and illness, to differentiate influenza from
COVID-19, and support COVID-19 surveillance. Data enhancements include
adding more than 1,000 emergency departments to the U.S. Outpatient
Influenza-like Illness Surveillance Network (ILINet), adding new data
sources from the National Long Term Care Facility Surveillance system
that reports data from approximately 15,400 facilities weekly, and
integrating HHS Protect hospital data from approximately 6,000
hospitals. Differentiation between influenza and COVID-19 is supported
by the CDC-developed multiplex assay for use by CDC-supported public
health laboratories, which simultaneously tests for type A and B
seasonal influenza viruses and SARS-CoV-2. These and other updates have
further strengthened the U.S. influenza surveillance system.
Question. I am alarmed by increasing antimicrobial resistance, and
the fact that high levels of antibiotic use during the COVID-19
pandemic have likely driven the development of new resistance threats
that have not yet been identified. The 2020-2025 National Action Plan
for Combating Antibiotic Resistant Bacteria calls for expanded efforts
that will only be possible with significant new Federal resources.
Addressing AMR is central to preparedness, as resistant secondary
infections complicate public health emergencies.
How does the President's Budget Proposal support the CDC Antibiotic
Resistance Solutions Initiative in fiscal year 2022 to expand efforts
to preserve the effectiveness of antibiotics, reduce inappropriate
antibiotic use, increase surveillance and ensure that we are prepared
to address this public health threat, as outlined in the 2020-2025
National Action Plan for Combating Antibiotic Resistant Bacteria?
Answer. The fiscal year 2022 President's Budget has $172 million
for the Antibiotic Resistance Solution Initiative, consistent with the
fiscal year 2021 appropriation. CDC is working to effectively leverage
resources and invest in key prevention strategies, such as early
detection and containment, infection prevention, and ensuring the
appropriate use of antibiotics. The availability of safe, effective,
and quality-assured antibiotics underlies much of modern medicine, and
the emergence and spread of AR threatens to undo this progress at
enormous human and economic cost.
COVID-19 has potentially created a perfect storm for antibiotic
resistance (AR) infections in healthcare settings, with longer lengths
of stay, crowding, severely ill patients, antibiotics frequently
prescribed upon admission, and infection control challenges like PPE
shortages. CDC supports a robust domestic infrastructure through its AR
Solutions Initiative to respond to emerging threats wherever they occur
across healthcare, the community, and the environment while building
key capacity to address AR internationally. CDC continues to use a One
Health approach to tackle AR and to gain a better understanding of AR
transmission, interactions, and impact between humans, animals, and the
environment.
CDC has also proposed ambitious plans to strengthen international
public health infrastructure as outlined in the 2020-2025 National
Action Plan for Combating Antibiotic-Resistant Bacteria (CARB). Over
the next 5 years of the plan, it proposes that CDC would establish two
networks--the Global Action in Healthcare Network and Global
Antimicrobial Resistance Laboratory & Response Network, which would
expand CDC's surveillance efforts globally.
Working together, these new global networks would enhance detection
and response to infectious disease threats internationally, and
implement prevention and containment strategies at local, national, and
regional levels. CDC also has proposed plans to expand surveillance of
AR threats in the environment, domestically and globally. These
activities would help to better understand resistance in the
environment, the connections between resistance in healthcare,
agriculture, and environmental settings, and its impact on human
health. CDC is piloting investments in these activities in fiscal year
2021.
Question. The COVID-19 pandemic laid bare the gaps resulting from
decades-long erosion of support for the public health workforce, which
did not have the people or resources needed to surge to meet the
demands of the emergency response. Strategic investments in a diverse,
robust, well-trained public health workforce at the community level are
critical to ensure that we are able to tackle local public health
challenges and be prepared for the next infectious disease outbreak.
President Biden's fiscal year 2022 budget proposal includes a request
for $106 million, a $50 million increase above fiscal year 2021, to
develop the next generation of essential public health workers.
How does CDC envision this proposed investment in fellowship and
training programs will translate in rebuilding the public health
workforce of epidemiologists, contact tracers, lab scientists,
community health workers, data analysts, behavioral scientists, and
communicators?
Answer. The COVID-19 response shone a stark light on deficiencies
in the nation's investment in its public health workforce, which did
not have the people or resources to surge to meet the demands of a
pandemic emergency response. Strategic investments in a diverse, well-
trained public health workforce are needed. CDC's fellowships and
training programs continue to supply a competent and sustainable
workforce capable of surging in response to imminent public health
threats.
CDC hosts approximately 300 fellows across seven fellowship
programs each year in 45 U.S. states and five territories. In fiscal
year 2021, all 137 EIS officers and Laboratory Leadership Services
(LLS) fellows contributed to the COVID-19 response, leading COVID-19
responses in their assigned states and publishing key findings in the
MMWR leading to actionable recommendations around mitigating the spread
of disease. CDC designs its fellowships and curricula to meet the
evolving needs of the public health workforce. A survey of human
resources directors identified the highest priority workforce needs as
epidemiologists, laboratory scientists, and public health informatics
specialists. CDC's fellowships are a pathway for training the next
generation of public health leaders.
Actions taken now to invest in developing the next generation of
essential public health workers will better position our communities
and the nation to respond to the current pandemic and to build back a
better workforce to safeguard Americans' health. With the fiscal year
2022 request of $106,000,000 for Public Health Workforce, CDC will
rebuild the workforce of epidemiologists, contact tracers, lab
scientists, community health workers, data analysts, behavioral
scientists, and communicators who can help protect America's health.
While health departments are the frontlines of emergency response,
Federal investment in workforce development is essential to a
coordinated national health workforce strategy. In fiscal year 2022 CDC
will:
--Expand the pathway of critical public health workers through
fellowship programs; assisting state, tribal, and local health
departments to conduct barrier assessments and implement best
practices for recruitment, hiring, and retention, and
publishing training materials for state, tribal, and local use
and STEM resources highlighting pathways to careers in public
health.
--Modernize workforce development information technology systems.
--Increase participants in CDC fellowship programs and place them in
areas of critical need.
CDC will invest in understanding barriers and facilitating
solutions around matching graduates in critical discipline areas with
positions serving local, tribal, and state communities. Developing
robust pathways to attract graduates to public health is essential to
future health security of the United States.
CDC will expand fellowship opportunities, from the Public Health
Associate Program to Epidemic Intelligence Officers. CDC will enhance
recruitment efforts and pave pathways for careers in public health at
the Federal, state, tribal, and local levels. Increasing the cohort of
EIS officers will provide critical applied learning and pathways for
the next generation of public health leaders. CDC will increase the
number of fellows in the field that provide essential assistance and
expertise to CDC and state, local, territorial, and tribal health
departments.
CDC will also strengthen the laboratory workforce to support
clinical and public health laboratory practice. Of the 800,000
laboratory professionals who work across 295,000 CLIA-certified
laboratories, less than 10 percent of the nation's clinical laboratory
professionals currently access CDC training and workforce development
resources. CDC will:
--Expand the reach of CDC's training and workforce development
resources beyond the public health laboratory community into
the broad clinical laboratory community, including those who
perform point-of-care testing, building critical bridges
between healthcare and public health.
--Continue data-driven development, promotion, and dissemination of
laboratory capacity- building initiatives and resources that
enhance the laboratory community's ability to combat emerging
threats, learn evolving practices, and stay current with the
newest standards and technologies
--Formalize partnerships to expand its reach and accessibility of its
training products and resources to the laboratory community
through its learning course syndication system.
--Expand development of its virtual reality training portfolio to
meet the evolving needs of laboratory professionals.
Question. How will state and local health departments benefit from
an expansion of these training programs?
Answer. With investment in CDC's fellowship and training programs,
CDC will rebuild the workforce of epidemiologists, contact tracers, lab
scientists, community health workers, data analysts, behavioral
scientists, and communicators who can help protect America's health.
These investments are essential to build a competent and empowered
public health workforce prepared to respond to future public health
emergencies. CDC will work with state, tribal, local, and territorial
health departments to rebuild the workforce and support these partners
to assist in hiring and recruitment; identify and address barriers to
hiring at the state and local levels; address workforce gaps; and build
capacity to respond to current and future public health threats. These
funds will support recruitment and training of public health leaders
through Epidemic Intelligence Services (EIS), Laboratory Leadership
Service fellowship programs, and Public Health Associate Program
(PHAP). They will complement other initiatives including:
--Public Health AmeriCorps, a new public health workforce program in
partnership with AmeriCorp, supported by investment from the
American Rescue Plan, will deploy a nationwide cohort of
workers, who will receive applied learning training and a
stipend in non-Federal term positions.
--Modernization of the public health workforce in which CDC will work
with public health leaders across Federal, state, local, and
territorial jurisdictions to create a new grant program to
provide under-resourced health departments with the support
they need to hire staff and build a public health workforce for
the future.
______
Questions Submitted by Senator Jeanne Shaheen
Question. Given that diabetes is one of the co-morbid conditions
that puts patients with COVID-19 at highest risk, I was pleased to see
CDC guidance that recommended prioritization of both Type 1 and Type 2
diabetes patients for vaccination. With 34 million Americans currently
living with diabetes, the economic cost of the condition now exceeds
$300 billion per year. Now more than ever, we need to do more to help
prevent Type 2 diabetes where possible and help people with diabetes
improve their management of the condition, so that we can see improved
outcomes.
How is CDC approaching the rapid growth in diabetes prevalence in
this country and what can we do in Congress to help?
Answer. CDC established the National Diabetes Prevention Program
(National DPP) to address the growing epidemic of type 2 diabetes. The
National DPP lifestyle change program is led by trained coaches who
facilitate participants' strategies for eating a healthy diet,
increasing physical activity, and developing coping skills. The
Diabetes Prevention Program clinical trial showed that participants who
engage in these lifestyle changes through a structured program can lose
five to 7 percent of their body weight and reduce development of type 2
diabetes by as much as 58 percent (71 percent for those 60 years of age
and older).
CDC supports state health departments and other stakeholder
organizations in expanding access to the National DPP for populations
at greatest risk for type 2 diabetes. Achieving insurance coverage is a
critical step for increasing access to this highly effective program.
Based on recipient reported data from September 30, 2018 to June 30,
2019, state health departments and other partners have secured health
insurance coverage for the National DPP for more than 1 million public
employees and their dependents in 24 states. In addition, the National
DPP lifestyle change program is currently a covered benefit for more
than 2.2 million private sector employees and their dependents across
21 states, a 61 percent increase from 2018. More than 1.4 million
Medicaid beneficiaries have the National DPP lifestyle change program
as a covered benefit, which includes participation from 30 states.
In March 2016, the Centers for Medicare & Medicaid Services (CMS)
certified the expansion of the National DPP into the Medicare program.
This was the first preventive service model from the CMS Innovation
Center to become eligible for expansion into the Medicare program--a
landmark for public health. The future of the MDPP as a covered service
will be determined by the outcome of the CMS Innovation Center's
expanded model evaluation. However, based on findings from the original
DPP research trial, subsequent translation studies demonstrating the
program's effectiveness in non-clinical settings, and the 15-year
results of the DPP Outcomes Study, this intervention has been studied
extensively and already has substantial evidence supporting its
effectiveness across settings and populations.
Question. Can you provide an update on CDC's investments in the
Division of Diabetes Translation (DDT) and the National Diabetes
Prevention Program (NDPP)? How is CDC measuring success for those
programs?
Answer. More than 550,000 people at high risk for developing type 2
diabetes have participated in the National DPP lifestyle change program
across the U.S. Evaluated participants have lost an average of 5.5
percent of their body weight. To date, there are almost 1,900 CDC-
recognized organizations offering the program in-person, virtual and
through distance learning. CDC aims to enroll 1 million participants
into the National DPP lifestyle change program by 2025.
Since the onset of the COVID-19 pandemic, a majority of the CDC-
recognized organizations are offering virtual (telehealth) options for
the National DPP lifestyle change program, an especially critical
feature to ensure participant safety. A 2017 study (Vadheim, L.M, et
al., 2017) found that participants who received the National DPP
lifestyle change program through telehealth videoconferencing (distance
learning) had similar rates of participation and achieved similar
weight loss as participants who attended the program in-person.
Through implementation of the National DPP, CDC aims to reduce the
number of adults newly diagnosed with type 2 diabetes. The national
rate of diabetes incidence (6.4 new cases per 1,000 adults in 2018) has
successfully moved below the Healthy People 2020 target (7.2 new cases
per 1,000 adults). The continued growth of the diabetes burden in terms
of absolute prevalence, lifetime risk, years spent with diabetes, and
the incidence rate remaining considerably higher than it was in the
1990s, are all contributing factors indicating a need for continued
prevention efforts like the National DPP.
Question. The COVID-19 pandemic has exacerbated challenges in our
response to the substance use disorder epidemic. As you know, the 2020
state-level CDC data on opioid overdose deaths will also dictate the
distribution of Federal opioid response dollars through the State
Opioid Response (SOR) grant program administered by the Substance Abuse
and Mental Health Services Administration (SAMHSA).
When does CDC expect to publish state-level data for 2020 on drug
poisoning deaths per capita? When CDC does publish the data, please
keep my office informed.
Answer. The National Center for Health Statistics provides
provisional drug overdose death data by state: Products--Vital
Statistics Rapid Release--Provisional Drug Overdose Data (cdc.gov).
Provisional data currently provides information on drug overdose deaths
occurring through October 2020. Final drug overdose death data for 2020
will be available in late 2021.
Question. Often there are discrepancies in state rankings on opioid
overdose deaths per capita compared to overall drug poisoning deaths
per capita. For instance, in examining CDC's WONDER data on 2018 opioid
overdose deaths per capita, as reported by the National Institute on
Drug Abuse (NIDA), compared to CDC's publication of 2018 overall drug
poisoning deaths per capita, New Hampshire ranks third in opioid
overdose deaths per capita and sixth in overall drug poisoning deaths
per capita. Will CDC publish data on opioid specific overdose deaths
per capita by state for 2020, as a supplement to its publication of
overall state-by-state drug poisoning deaths per capita in 2020?
Answer. Yes. In addition to drug overdose death data (including
deaths attributed to opioids) CDC provides analyses on final drug
overdose death data, including deaths related to prescription opioids,
heroin, synthetics opioids, and psychostimulants. CDC will update the
data once final 2020 overdose data are available.
CDC currently funds 47 states and the District of Columbia to
improve the timeliness and comprehensiveness of unintentional/
undetermined drug overdose mortality data. The State Unintentional Drug
Overdose Reporting System (SUDORS) captures detailed information on
toxicology, death scene investigations, route of administration, and
other risk factors that may be associated with a fatal overdose from
funded recipients. CDC continues to release analyses of data received
through this program. For example, CDC published a report describing
decedent demographic characteristics and circumstances surrounding
overdose deaths during January--June 2019 among 25 jurisdictions
participating in SUDORS, and it highlights the involvement of opioids
and stimulants, separately and in combination.
Question. I was pleased to see that the administration's budget
proposal calls for a continued commitment to efforts to defeat HIV in
this country. At the same time, we are also seeing significant
increases in the spread of sexually-transmitted diseases, including a
heartbreaking 40 percent increase in congenital syphilis passed from
mother to child during pregnancy in recent years. I have been concerned
that we have underfunded state and local STD prevention efforts for a
long time, which may impede our abilities to stop the spread of STDs.
Can you discuss how CDC is addressing growing rates of STD
infections, and congenital syphilis infections in particular?
Answer. CDC provides national leadership, research, policy
assessment, and scientific information about STDs to the medical
community and the public. CDC coordinates and publishes national STI
Treatment Guidelines and Recommendations, which translates research
into practice and serves as the gold standard for STI care in the
United States. Further, CDC supports health departments in all 50
states, Washington, D.C., and select cities and territories to conduct
core and essential STD prevention work through our flagship STD
prevention program, totaling $95.5million in 2020. CDC also has seventy
field staff embedded in state and local STD programs around the
country, who provide technical assistance and capacity building in
disease investigation to support communities and public health
partners, including investigating STDs in the community through field
testing, public health detailing, outbreak response, and contact
tracing.
COVID-19 mitigation necessitated innovative approaches to
delivering STD care that may prove to be valuable investments into the
infrastructure for STD care in the U.S. for years to come, including
(but not limited to):
--STD express clinics, which provide walk-in testing & treatment
without a full clinical exam
--Partnerships with pharmacies & retail health clinics, which can
provide new access points for STD services (e.g., on-site
testing and treatment)
--Telehealth/telemedicine, which can close gaps in testing and
treatment, ensure access to healthcare providers, support self-
testing or patient-collected specimens, and is especially
critical in rural areas
These strategies and more are outlined in HHS's first ever STI
Federal Action Plan, which provides a roadmap to develop, enhance, and
expand prevention and care programs at the national, state, tribal and
local levels over the next 5 years to reverse the course of the STD
epidemic.
Further, through its flagship STD prevention program, CDC supports
state and local public health departments to prioritize and strengthen
their efforts to eliminate congenital syphilis by matching syphilis
surveillance data with birth and mortality data and strengthening
congenital syphilis morbidity and mortality case review boards. On July
13, CDC funded four state STD programs, working in cooperation with the
state epidemiologist, to ensure that the implementation of congenital
syphilis projects prioritize sustainable system level or policy level
interventions in alignment with local epidemiology.
Finally, CDC is working diligently to support the Disease
Intervention Specialists (DIS) Workforce with funding from the American
Rescue Plan. For many years, DIS have provided invaluable support to
prevent and control STDs, tuberculosis, HIV, and other infectious
diseases. More recently, DIS were called to support the COVID-19
response, conducting case investigation and contact tracing in a
variety of community settings. CDC is making a $1.13 billion investment
over a five-year period to continue supporting the COVID-19 response
and other infectious disease prevention and response, by:
1. Expanding and enhancing frontline public health staff
2. Conducting DIS workforce training and skills building
3. Building organizational capacity for outbreak response
4. Evaluating and improving recruitment, training, and outbreak
response efforts
In addition to helping to contain and prevent COVID-19, we expect
that this cadre of culturally competent and experienced DIS will be
able to address STDs, such as congenital syphilis, as well as other
infectious diseases.
Question. In 2016, the New Hampshire Department of Health & Human
Services requested that the CDC's Agency for Toxic Substances and
Disease Registry (ATSDR) conduct health consultations for the public
water systems and private wells in the Merrimack-area of southern New
Hampshire after the discovery of per- and polyfluoroalkyl substances
(PFAS) contamination in drinking water. It is my understanding that
these health consultations remain ongoing, and I am concerned that
residents are still waiting and wondering about their exposure risks.
Can you provide an update on the status of these health
consultations and when you expect they will be concluded and released?
Answer. ATSDR continues to work on the private well and public
water health consultations. ATSDR received comments on the private well
health consultation from the state environmental department through our
data validation review process and is working to address those
comments. After the comments are addressed the document is reviewed
through CDC's clearance process, it will be released for public
comment.
In addition, ATSDR is currently completing a draft of the public
water health consultation and preparing for internal review and
clearance.
Question. The last thing firefighters should have to worry about is
the safety of the equipment they wear while in the line of duty. Yet
many active and retired firefighters are deeply concerned about
exposure to harmful PFAS chemicals from their protective gear. I was
proud to include my bipartisan Guaranteeing Equipment Safety for
Firefighters Act provisions in the fiscal year 2021 National Defense
Authorization Act (NDAA), which as you know, includes collaborative
efforts at the National Institute of Standards and Technology (NIST)
and National Institute for Occupational Safety & Health (NIOSH) to
study of the personal protective equipment worn by firefighters. I have
also worked through the Appropriations process to kick start this
research at NIST.
Can you discuss the CDC's current collaboration with NIST as they
work to identify a firefighter's relative risk of exposure to PFAS
released from their protective gear? How will NIST's study inform the
CDC's work--within both ATSDR and NIOSH--to better understand the
health effects of PFAS exposure?
Answer. CDC's collaborates with NIST, sharing information,
presentations, and collaborating on research activities such as
characterizing PFAS in turnout gear textiles. In 2021, NIST and NIOSH
provide overviews of PFAS activities and identified three topics for
further discussion, analytical and collection methodologies, selection
of and access to turnout gear textiles, and PFAS toxicity testing.
Meetings on these topics were conducted with smaller groups to help
facilitate targeted discussions.
NIST's research into PFAS in firefighter turnout gear is
anticipated to provide valuable information on potential exposures for
firefighters by identifying PFAS present in textiles and the conditions
contributing to the release of PFAS from said material. The analytical
methods included in NIST's study comprise a larger panel of PFAS than
is currently used in many studies of human exposure. Results from this
expanded panel will help guide future PFAS analyses of serum collected
from this occupationally exposed population as well as inform future in
vivo and in vitro studies of toxicity. When paired with studies of
dermal absorption and exposure assessments of firehouse air or dust,
NIST's research will also provide insight into the contribution of PFAS
from gear to a firefighter's total exposure, providing a more complete
understanding of the relevant pathways and routes of exposure in this
population.
NIOSH's National Personal Protective Technology Laboratory (NPPTL)
has been collaborating with NIST to determine which PFAS compounds are
on firefighter turnout gear and if they are released through
laundering. NPPTL collaborated with NIST, providing 20 different
textile swatches laundered using current fire service protocols. These
samples will undergo additional aging and stressing techniques to
measure PFAS release from textiles by NIST researchers.
NPPTL's comprehensive laundry study to identify and quantify the
individual PFAS compounds on firefighter textiles and to measure their
release through a series of washings, supplements the ongoing NIST work
. Additional NPPTL research studies the ability of PFAS compounds to
migrate through the 3-layered garment to be in direct contact with a
wearer's skin.
The NIST-NIOSH research collaboration will provide valuable
information regarding possible PFAS exposures related to firefighter
PPE and will yield time and monetary cost savings to both institutes.
Question. The Firefighter Cancer Registry Act, which was passed by
Congress and signed by the President in 2018, directed the CDC to
establish and maintain a voluntary National Firefighter Registry to
better understand the link between on-the-job exposure to toxic
substances and cancer in firefighters. The National Firefighter
Registry will be used to track and analyze cancer trends and risk
factors among firefighters. I have heard from firefighters in my state
interested in volunteering to participate. It is my understanding that
at this time, however, enrollment for the National Firefighter Registry
is not yet open.
Can you provide an update on the work being done to establish the
registry and a timeline of when it will be open for enrollment? When
the registry is opened for enrollment, will you work with my office to
provide information to active and retired firefighters about how to
participate if they so choose?
Answer. The National Firefighter Registry (NFR) has made
substantial progress in developing a rigorous scientific protocol,
enrollment questionnaire, and consent form. These documents have been
posted publicly at www.cdc.gov/niosh/bsc/nfrs. The enrollment
questionnaire has been submitted to OMB for review under the Paperwork
Reduction Act. The NFR program has also drafted an Assurance of
Confidentiality (AoC), which provides additional protection for
identifying information.
The NFR program has also made progress on the online NFR
Registration System. However, any public-facing data collection portal
must meet numerous Federal data security regulations and requirements--
some of which are relatively new and costly. NIOSH is working closely
with our IT and security specialists to ensure that the NFR
Registration System is compliant with these requirements. This has
extended the original timeline for the launching of the NFR. NIOSH also
recognizes that the registration system not only needs to be highly
secure, but also needs to be relatively easy for firefighters to
complete in order to maximize voluntary participation across the United
States.
The NFR team has been working closely with key scientific and fire
service stakeholders to determine the optimal design of the NFR
Registration System and what data must be collected. Launching of the
NFR Registration System is one step in many that will be needed over
the next several years to ensure the success of the program and meet
the requirements under the Firefighter Cancer Registry Act of 2018.
Once the NFR opens for registration, NIOSH will work with numerous
fire service organizations and other stakeholder groups to encourage
firefighters throughout the country, including career and volunteer,
active and retired, and firefighters with and without cancer, to enroll
in the NFR. The NFR team has developed a robust communications plan and
strong connections to fire service organizations such as the
International Association of Fire Fighters (IAFF) and National
Volunteer Fire Council (NVFC), which are the two largest organizations
representing career and volunteer firefighters, respectively. We
welcome opportunities to work with congressional offices to reach
firefighters within your state or district.
Question. Can you discuss how you expect this epidemiological
information and analysis will help public safety officials,
researchers, scientists and medical professionals find better ways to
protect those in the fire service?
Answer. The enrollment questionnaire will serve as the primary data
collection instrument when firefighters initially register collecting
information about work history (including large or unusual responses),
implementation of control measures, family history of cancer, and
healthy behaviors. The questionnaire will also ask for identifying
information, such as name and date of birth, which can be used to make
linkages to state cancer registries. Collecting identifying information
will allow NIOSH to periodically link to existing cancer diagnosis
databases to detect new cases of cancer long-term that may not have
been reported.
Additional follow up questionnaires will allow for analysis of
specific workplace factors as well as topics of special interest to the
public safety community. The NFR program also plans to work with fire
departments to capture fire and incident information to build an
exposure profile for the NFR participants. Over time and with broad
participation, all this data can be used to better understand the
amount and types of cancer among firefighters; the prevalence of cancer
risk factors and healthy behaviors among firefighters; and the
relationship between firefighter cancer and workplace characteristics,
exposures, and practices. We will explore cancer risk among
understudied firefighter groups including women, minorities,
volunteers, and firefighters in sub-specialty assignments like wildland
firefighters or fire-cause investigators. We will also evaluate how the
adoption of certain control measures, like routine laundering of
turnout gear, affects cancer risk. These analyses will help scientists
at CDC/NIOSH identify the most important factors associated with
firefighters' risk of specific types of cancer, including rare forms of
cancer. Results can then be used by public safety officials to
implement new evidence-based policies or procedures to reduce
firefighters' cancer risk. Medical professionals will also have more
knowledge about the types of cancer that are most elevated among the
different groups of firefighters, which could assist them in providing
advanced screening and healthcare for firefighters.
______
Questions Submitted by Senator Joe Manchin, III
Question. The Food and Drug Administration reports that nearly 40
percent of finished drugs and roughly 80 percent of active
pharmaceutical ingredients are manufactured abroad. During the COVID-19
pandemic we saw factories shut down in order to prevent spread of the
virus, drug supply chains disrupted, and drug shortages increase. As a
result American's access to essential medicines was put into jeopardy.
To avoid future shortages of essential medicines, domestic
manufacturing is key to shoring up our supply chain.
How important is a strong domestic supply chain for essential
medicines?
Answer. Ensuring a safe and consistent public health supply chain
for medical materials, ingredients, and supplies is critical for any
national response to public health emergencies.
Question. How can we ensure we don't experience future drug
shortages when global supply chains are disrupted?
Answer:
--Investments in securing the industrial base and domestic supply
chain require dedicated and persistent management and
engagement.
--Throughout the COVID-19 response, ASPR has leveraged the
authorities delegated to the Secretary under the Defense
Production Act (DPA) to issue 62 priority ratings for United
States Government (USG) contracts for health resources, eight
priority ratings for USG contracts for industrial expansion,
three priority ratings for non-USG contracts to support the
production of resins for both diagnostics and infusion pumps,
and the manufacture of closed suction catheters for treatment
of patients with COVID-19--all to ensure private sector
partners making life-saving products are able to acquire the
raw materials, components, and products requisite to deliver
for the response.
--Also under the DPA, ASPR is strengthening the industrial base to
secure and develop domestic capacity, retool and expand
industry machinery, scale production facilities, train
workforces, and ultimately infuse the supply chain and
marketplace with products the US needs to contain further
pandemic waves. ASPR continues to invest in critical funding in
expanding domestic manufacturing including investments of: $250
million in manufacturing PPE; $268 million in manufacturing of
testing consumables; $14.8M in vaccine raw material
manufacturing; $160 million in fill finish capacity; $65
million in vaccine vial manufacturing; $168 million in
manufacturing capacity for at home and point of care tests;
and, $53.8M in testing raw materials. Each of these domestic
manufacturing initiatives meets current, as well as future
COVID-19 needs, and seeks to create or sustain high-value
domestic jobs.
Question. Last week, the CDC announced $7.4 billion from the
American Rescue Plan to support the public health workforce and the
response to the COVID pandemic. This funding included $2 billion for
state health departments. This will go a long way to shoring up our
public health workforce as you outlined, in particular the requirement
for at least 40 percent of the funding to support local hiring through
local health departments or community-based organizations. West
Virginia led the country in vaccination rates in large part due to our
local health departments and health centers across the state
establishing Local Leadership Planning teams to roll out vaccination
plans in all 55 counties. These teams are multisector,
multidisciplinary local health leaders. They know their communities,
and have stepped up to respond to this virus.
In addition to this funding, what is CDC doing to support local
initiatives like West Virginia's Local Leadership Planning teams?
Answer. Partnerships and trusted community members have been
critical to reaching communities disproportionately affected by the
pandemic. Community health workers (CHW) are frontline public health
workers who have a trusted relationship with the community and are able
to facilitate access to a variety of services and resources for
community members. Scaling up and sustaining a nationwide program of
CHWs who support populations hit hardest by COVID-19 is critical. In
addition to the $7.4 billion to support the public health workforce
awarded from the American Rescue Plan, CDC also plans to provide $300
million to jurisdictions for CHW services to support COVID-19
prevention and control. CDC plans to provide an additional $32 million
for training, technical assistance, and evaluation. CDC expects to
award funds to approximately 75 organizations through the ``Community
Health Workers for COVID Response and Resilient Communities.'' Notices
of awards will be issued in the summer, with the amount each
jurisdiction receives determined by population size, poverty rates, and
COVID-19 statistics.
CDC also provided funding with specific guidance to focus on
reaching disproportionately affected communities, including:
--$3 billion to strengthen vaccine confidence (awarded early April
2021): Funding focuses on reaching 64 communities hit hardest
by the pandemic, including those in rural areas, to ensure
greater equity and access to vaccine and expand COVID-19
vaccine programs. To ensure health equity and expanded access
to vaccines, 75 percent of funding must focus on specific
programs and initiatives intended to increase vaccine access,
acceptance, and uptake among racial and ethnic minority
communities, and 60 percent must go to support local health
departments, community-based organizations, and community
health centers.
--$3 billion in cooperative agreements to support broad-based
distribution, access, and vaccine coverage (awarded Jan. 2021):
A minimum of 10 percent to jurisdictions must be allocated for
high-risk and underserved populations, including rural
communities.
--75 percent of the total funding must focus on specific programs
and initiatives intended to increase vaccine access,
acceptance, and uptake among racial and ethnic minority
communities; and,
--60 percent must go to support local health departments,
community-based organizations, and community health
centers.
--$2.25 billion in grant funding to states and localities
(anticipated to be awarded June 2021) to address COVID-19 in
high-risk and underserved communities, including rural
communities and communities with large populations of racial
and ethnic minorities. Recipients are strongly encouraged to
collaborate with and provide funding and resources to reach
organizations such as community-based and civic organizations,
faith-based organizations, non-governmental organizations, and
state offices of rural health or their equivalent such as state
rural health associations.
Question. How can we maintain local efforts like these to ensure
they continue to operate after the public health emergency?
Answer. CDC must build on initial investments and lessons learned
from COVID-19 with sustained, flexible investments in the nation's
public health infrastructure as proposed in the fiscal year 2022
Budget. This work must include public health workforce development, as
well as public health data modernization and epidemiology and
laboratory capacities, so that we can address the broader public health
consequences of the pandemic such as opioids, injuries, violence,
immunization, and chronic disease control. It will also help us prepare
for the future, because there are and will be more public health
threats.
Question. Just last week the CDC updated its guidelines in regards
to people who have been fully vaccinated. One guideline has caused
confusion in my state, specifically in regards to reporting and the
quarantining of people who have been vaccinated with a known exposure
to COVID. Currently, the guidelines require a fully vaccinated person
to quarantine for 10 days only if they develop symptoms. However, there
does not appear to be a clear reporting requirement for persons who
have been exposed and develop minor symptoms. Nor is there flexibility
for a fully vaccinated person to quarantine for a shorter period of
time if their symptoms disappear. Tracking these breakthrough cases is
important to ensure we know if and when a booster may be needed to
ensure protection for our population, and tracking potentially
problematic COVID variants.
How does the CDC plan to effectively monitor breakthrough cases?
Answer. The goal of national surveillance for COVID-19 vaccine
breakthrough infections is to identify unusual patterns, such as trends
in age or sex, the vaccines involved, underlying health conditions, or
which of the SARS-CoV-2 variants made people sick. To date, CDC's
monitoring of breakthrough cases shows there are no unusual patterns in
cases that have been detected in the data CDC has received. Despite the
high level of vaccine efficacy, it is expected that a small percentage
of fully vaccinated persons will develop symptomatic or asymptomatic
infections (i.e. breakthrough infections) with SARS-CoV-2, the virus
that causes COVID-19.
Vaccine breakthrough surveillance focuses on those cases resulting
in hospitalization or death. CDC coordinates with state and local
health departments to investigate vaccine breakthrough cases and
identify patterns or trends. Health departments report breakthrough
cases to CDC on a voluntary basis. However, it is important to note
that tracking and publicly reporting vaccine breakthrough via national
surveillance is just one way CDC measures vaccine effectiveness. CDC is
leading multiple vaccine effectiveness studies, some of which include
information on vaccine breakthrough infections, to ensure COVID-19
vaccines are working as expected. Through these studies in various
populations, locations, and settings, CDC can obtain more
representative, scientifically valid, and complete information about
these types of infections.
CDC is also using the Coronavirus Disease 2019 (COVID-19)-
Associated Hospitalization Surveillance Network (COVID-NET) to track
and analyze breakthrough infections. This population-based surveillance
system includes data on laboratory-confirmed COVID-19- associated
hospitalizations in 99 counties in 14 states, representing
approximately 10 percent of the U.S. population. COVID-NET cases are
hospitalizations occurring in residents of a designated COVID-NET
catchment area who are admitted within 14 days of a positive SARS-CoV-2
test. COVID-NET personnel collect COVID-19 vaccination status (doses,
dates administered and product) from state Immunization information
systems (IIS) for all sampled COVID-NET cases in 13 sites, which also
include information on clinical outcome. Some sites have expanded
collection of vaccination status to non-sampled cases, which were
included for analysis if all cases in a single month had vaccination
status available.
Question. Is the CDC considering reducing the required isolation
period for fully vaccinated persons after their symptoms disappear?
Answer. CDC data indicates that vaccinated people are less likely
to contract COVID-19 and are much safer from having serious outcomes if
they do contract it. If they become infected, they can spread the virus
to others. Moreover, if the infection is caused by the Delta variant,
based on what we know at this time, they can likely spread it as easily
as unvaccinated people who are infected, at least initially. As
infection progresses, vaccinated persons with COVID-19, including
COVID-19 caused by the Delta variant, appear to be infectious for a
shorter period of time than infected unvaccinated people.
CDC is reviewing all the emerging evidence and will continue to
monitor the data on duration of infectiousness for breakthrough cases.
Throughout the pandemic, CDC has updated guidance to reflect the latest
available information about COVID-19 and would consider changing
recommendations for isolation periods for vaccinated people who have
breakthrough infections if the accumulating science indicates such a
change were both safe and reasonable.
Question. As you are aware we are facing an epidemic within a
pandemic. West Virginia is ground zero for the drug epidemic, with the
highest rate of drug overdose deaths in the country. To make matters
worse, 2020 was the worst year for drug overdoses, with over 90,000
deaths. West Virginia saw at least a 47 percent increase in overdose
deaths last year. The drug epidemic has led to a sharp increase in
opioid-related infectious diseases, including HIV and viral hepatitis.
This has stretched the resources of our public health departments and
health providers even further.
What resources is the CDC providing to states to combat this
epidemic?
Answer. CDC is providing resources to states through Overdose Data
to Action (OD2A), a cooperative agreement that began in September 2019.
It combines strategies from previous surveillance and prevention
funding agreements to address the complex and changing nature of the
drug overdose epidemic. Through OD2A, 47 states, Washington D.C., 16
localities, and two territories are receiving almost $300 million in
funding.
CDC is also addressing the infectious disease consequences of the
opioid epidemic. Nearly $13 million of combined fiscal year 2019 and
fiscal year 2020 funding was awarded through the Infectious Disease and
the Opioid Epidemic initiative to state and local health departments
and national organizations to address the infectious disease
consequences of drug use.
In light of the COVID-19 pandemic, CDC has worked to provide
flexibilities to the 66 grantees by extending the funding for an
additional year and providing additional guidance and assistance as
needed. We have also engaged grantees to identify innovative ways to
respond during the pandemic. We are also using COVID-19 funding to:
--Understand how substance use patterns and attitudes among youth
have changed due to COVID-19 and disseminate tailored public
health messaging and interventions to help address increased
substance use during this period of time and prevent
detrimental long-term consequences.
--Identify innovative harm reduction practices to assess the extent
to which these strategies can be sustained and scaled. CDC
plans to summarize these strategies and disseminate them to
state, local, and Federal partners.
In addition, CDC is Combating Opioid Overdose Through Community-
level Intervention Initiatives (COOCLI). CDC, through its Opioid
Response Strategy partnership, provided funding to the Office of
National Drug Control Policy to create public health/public safety
interventions at the local level. COOCLI sub-awards funded pilot
programs to implement innovative, evidence- based, community-level
interventions.
Question. Is the CDC working on helping increase testing for viral
hepatitis and HIV as well as linking patients to care?
How can CDC help improve testing and surveillance of opioid-related
infectious diseases with our current substance use treatment programs
and recovery facilities?
Answer. Our nation has seen steady increases in infectious
diseases--including viral hepatitis and HIV--among people who use drugs
since the start of the opioid crisis over a decade ago. Making testing
for viral hepatitis and HIV accessible, convenient, and routine is
critical, especially in populations disproportionately affected by
these diseases, including people who inject drugs (PWID). CDC developed
programs to increase infectious disease testing among PWID and
continues to invest in these programs through state and local health
departments and through community-based organizations. Specifically,
CDC is focusing investments on scaling up HIV self-testing--like the
Take Me Home self-testing program that provides free HIV self-tests--
making HIV screening a regular part of healthcare, and delivering viral
hepatitis and HIV testing in non- traditional settings, such as
correctional facilities and syringe services programs (SSPs).
As viral hepatitis, HIV, and substance use disorders continue to
impact communities throughout the United States, CDC is not only
increasing support for testing, but also diagnosis, linkage to care,
and treatment. CDC is also improving implementation of and access to
high-quality SSPs across the country, where legal, through
dissemination of best practices and providing technical assistance.
CDC's core Integrated HIV Surveillance and Prevention for Health
Departments program (PS18-1802) supports the implementation of
comprehensive SSPs as part of a key community-level HIV prevention
strategy. In addition, CDC's National HIV Behavioral Surveillance
system collects important data among persons at high risk for HIV
infection, including persons who inject drugs. These programs work to
ensure the provision of high-quality, comprehensive harm reduction
services, which include testing for infectious diseases, linking
patients to opioid use disorder treatment, and providing infectious
disease care for clients of syringe services programs.
In addition to testing and treatment for infectious diseases, CDC
works to increase linkage to substance use disorder treatment within
SSPs and during healthcare encounters for PWID.
Question. The COVID-19 pandemic has revealed public health data
infrastructure shortcomings within both our Federal and state
institutions. West Virginia's response to the COVID-19 pandemic,
however, shows our ability to adapt in times of crisis. In addition to
the strong leadership of our National Guard, our local health
information exchange stepped up to track important health data, such as
hospitalization and vaccination rates, demographic data, and much more.
Most importantly, our health information exchange helped us build out
systems so that West Virginia health providers were able to fully
utilize the CDC's Vaccine Administration Management System (VAMS). As
outlined in President Biden's national strategy, we need improved
systems for public health data exchange and surveillance. This will
allow us to better track outbreaks, testing, vaccination rates and much
more.
How will you ensure Federal investments into public health data
will support data sharing between public health and healthcare
delivery, such as the West Virginia's health information exchange?
Answer. The success of CDC's Data Modernization Initiative (DMI) is
critical for our nation's response to COVID-19 and beyond. Improving
data sharing between public health and healthcare delivery is key to
realizing the full potential of public health data modernization.
Monitoring and evaluation are how we make sure we are delivering on the
promise of data to protect America's health. The need for modernization
never stops. Within DMI, we are monitoring progress on a growing suite
of modernization projects. These investments touch nearly every part of
the public health data ecosystem.
All of CDC's data modernization investments are guided by a Roadmap
of Activities and Expected Outcomes that guides all current and future
investments in data modernization. This strategic roadmap lays out our
priorities and keeps our end goals in front of us. It ensures work
going on through any given stream ties into and benefits the others--
and that we are moving toward the same definition of success. The
roadmap is the basis for our DMI monitoring and evaluation framework.
Robust monitoring and evaluation will maximize our impact on public
health. This is where we track our progress consistently and
scientifically to see what our investments have produced. We can also
see which solutions are working well and which may need additional
support to reach their goals.
Electronic case reporting (eCR) has demonstrated success in
improving data sharing between public health and healthcare. eCR is the
automated, real-time exchange of case report information between
electronic health records (EHRs) and public health agencies for review
and action. It moves data quickly, securely, and seamlessly from EHRs
in healthcare facilities to state or local health departments. All 50
states, D.C., and 11 large local jurisdictions are now capable of
receiving COVID-19 electronic case reports, up from only a handful of
jurisdictions in late 2019. As of May 15, more than 8.1 million COVID-
19 reports have been sent to 61 public health agencies and more than
7,900 healthcare facilities in all 50 states can send COVID-19
electronic case reports. There are currently 236 facilities in West
Virginia actively using eCR, including West Virginia University.
CDC is actively working to expand the number of healthcare
organizations implementing eCR and support public health agencies to
fully use the case reports within their data ecosystem. This includes
collaboration with healthcare systems, EHR vendors, and with the Office
of the National Coordinator for Health Information Technology (ONC) to
improve exchange of health information.
Question. Will you work with state partners like WVU Health
Sciences to continue to improve data analytics?
Answer. Support and engagement with partners to improve data and
analytics is an important component of the CDC Data Modernization
Initiative (DMI). Data modernization requires an ongoing commitment and
partnership across the public health sector--and especially with our
state, tribal, local, and territorial partners. CDC will continue to
support and engage with partners to improve data collection,
interoperability and data analytics. CDC is working closely with public
health partners to provide technical assistance focused on:
--Developing interoperable data systems to reduce the burden on
healthcare systems, facilities and laboratories that report
critical data to jurisdictions
--Increasing the overall efficiency of public health data systems at
the state level
CDC also supports public health partners like the Association of
Public Health Laboratories (APHL) and the Council of State and
Territorial Epidemiologists (CSTE). These partners are providing
technical assistance to jurisdictions focused on improving data
sharing, accelerating use of shared decision support services, data
science upskilling of the public health workforce, and developing and
increasing use of standards to improve quality and timeliness of
reported data.
______
Questions Submitted by Senator Roy Blunt
Question. Dr. Walensky, several of the COVID-19 vaccine developers
have indicated we may need a vaccine booster. To that end, BARDA
notified an intent to purchase 400 million doses of COVID-19 vaccine
from Moderna and Pfizer for $7.9 billion on May 2nd as booster shots.
Was that the right decision? Because many public health experts
indicate, including former CDC Director Tom Frieden, that there is
growing evidence that a first round of global vaccinations may offer
enduring protection. What is your opinion here? What I think could be
very dangerous is if vaccine companies, rather than public health
experts, are setting the public's expectations around COVID-19
boosters.
Answer. CDC will update its recommendations on re-vaccination or
additional doses of COVID-19 vaccines when additional information is
available. CDC is closely collaborating with Federal partners and the
global science and public health community to determine next steps on
COVID-19 vaccine boosters. Currently, there is not enough data to
support recommending boosters.
Question. Adult immunization programs are not typically done well
in the U.S.
Should we face the prospect of COVID-19 boosters next year, what is
CDC doing now to plan for that possibility?
Answer. CDC will update its recommendations on re-vaccination or
additional doses of COVID-19 vaccines when additional information is
available. CDC is closely collaborating with Federal partners and the
global science and public health community to determine next steps on
COVID-19 vaccine boosters. CDC works continuously with our state and
local immunization programs to strengthen their capacity to deliver
vaccines, monitor their safety and effectiveness and address identified
gaps.
The fiscal year 2022 budget request includes nearly a $100 million
increase to expand existing efforts to enhance the adult immunization
infrastructure to increase routine vaccination rates, detect and
respond to outbreaks of VPDs, and address vaccine hesitancy. Adult
immunization program funding will build on recent investments in the
COVID-19 vaccine program to support essential activities aimed at
strengthening the safety net for uninsured adults, addressing
disparities in adult vaccine coverage, and supporting vaccine efforts
across the lifespan.
Question. Will you try to team other adult vaccinations with the
COVID vaccination?
Answer. COVID-19 vaccines were previously recommended to be
administered alone, with a minimum interval of 14 days before or after
administration of any other vaccines. This was out of an abundance of
caution and not due to any known safety or immunogenicity concerns.
However, substantial data have now been collected regarding the safety
of COVID-19 vaccine currently authorized by FDA for use under Emergency
Use Authorization. Although data are not available for COVID-19
vaccines administered simultaneously with other vaccines, extensive
experience with non-COVID-19 vaccines has demonstrated that
immunogenicity and adverse event profiles are generally similar when
vaccines are administered simultaneously as when they are administered
alone.
COVID-19 vaccines and other vaccines may now be administered
without regard to timing. This includes simultaneous administration of
COVID-19 vaccine and other vaccines on the same day, as well as
coadministration within 14 days. When deciding whether to co-administer
vaccine(s) with COVID-19 vaccine, vaccination providers should consider
whether the patient is behind or at risk of becoming behind on
recommended vaccines, their risk of vaccine-preventable disease (e.g.,
during an outbreak or occupational exposures), and the reactogenicity
profile of the vaccines.
Question. There are reports, many of which the CDC has published,
highlighting the toll this pandemic has had on our nation's public
health. And there's an increasing number of reports that the overall
health of Americans has suffered as a result of the pandemic. It is
increasingly evident that in the coming months, as we emerge from under
the shadow of this pandemic, existing and emerging public health
challenges will have to be addressed.
How are you planning to address these challenges and how does the
fiscal year 2022 budget reflect those needs?
Answer. CDC is committed to upgrading the public health system so
the nation is ready for whatever may come next by building on
investments and lessons learned during the pandemic. Key priorities
include modernizing our public health data systems, supporting a
diverse and skilled public health workforce, enhancing laboratory
capacity, and promoting global health security. We now know that long-
term and flexible funding--as proposed in the fiscal year 2022 budget--
will be required to sustain improvements and address broader
consequences of the pandemic and historical underinvestment in areas
like health equity, opioid use and misuse, injuries and violence,
immunization planning, and hypertension control.
Question. What are the areas where this budget request may fall
short--perhaps because we're only just beginning to understand the vast
impact of the pandemic in areas such as chronic conditions, delayed
care and immunizations, or reemerging infectious diseases, such as STDs
and hepatitis?
Answer. The nation's public health system has not recovered from
the economic downturn in 2008, which resulted in significant reductions
in public health staffing at the state and local level. Similarly, CDC
has become increasingly reliant on infusions of supplemental funds to
address specific health crises. Building back a robust public health
infrastructure will take sustained investments over time to address
both foundational needs like data, lab capacity and workforce as well
as strategic investments to address health equity and social
determinants of health. The fiscal year 2022 President's budget
includes request for increased funding needed to address some of the
consequences of the pandemic including mental health, opioids, and
prevention of chronic and infectious diseases.
Question. Conversely, our nation has made great strides these last
several months against the COVID pandemic and we've gained a greater
understanding as to what is needed for a robust public health system--
from the public health laboratories to health statisticians and
academic researchers to private enterprise--advancements have been made
across the board.
How does the fiscal year 2022 budget request account for the
lessons learned over the last year to improve our public health
infrastructure?
Answer. The ability to respond to a public health emergency
requires a strong day-to-day public health system, supported by
infrastructure that is not highly segmented by disease, condition, or
activity. In addition to the COVID-19 pandemic, over the past 24
months, CDC has also responded to diverse public health threats from E-
cigarette or Vaping Product Use-Associated Lung Injuries (EVALI),
Ebola, complex multi-state food-borne disease outbreaks, wildfires, and
hurricanes. Responding to the unique characteristics of each of these
public health emergencies has required deep scientific expertise to
deploy a specialized approach and called for a robust public health
system with world-class infrastructure nationwide to stop disease at
its source. Unfortunately, this recent history has revealed the effects
of inadequate public health infrastructure. Ongoing health disparities
made us as a nation more vulnerable to pandemics and large-scale public
health emergencies, as well as burdening large segments of our
population with chronic public health concerns. Additional investment
in both domestic and global public health infrastructure is needed as
requested in the fiscal year 2022 Budget.
With investments requested in fiscal year 2022, CDC will begin to
address mission-critical gaps in public health infrastructure and
capacity nationwide. Transitioning from sporadic influxes of
supplemental funding tied to a specific emergency to flexible funding
that can prevent another crisis will strengthen the current public
health system. Flexible, sustainable investments in infrastructure and
capacity are critical for saving lives and averting economic losses
caused by public health emergencies and chronic public health problems.
In fiscal year 2022, CDC will prioritize funding to rebuild the most
critical public health infrastructure needed to safeguard the nation's
health and economic security.
Question. The budget includes $400 million for Public Health
Infrastructure Capacity.
How does this request account for the flexibility needed to scale
certain functions or respond in the future to a wholly different public
health threat?
Answer. CDC will expand its ability to leverage public health
infrastructure to address emerging and longstanding issues by providing
direct funding for capacity-building resources, guidance, and
collaboration to states, localities, and territories. These resources
will be disease-agnostic investments in core public health
infrastructure and capacity to expand programs and systems that address
long-standing public health issues and support public health response.
Question. How, specifically, will this $400 million be divided
between the different activities outlined in the budget?
Answer. This investment must be flexible, stable, and keep pace
with inflation and technological advancements in order for states,
localities, and territories to address their most urgent needs, such
as: a diverse, data-savvy workforce with secure funding that attracts
the best talent to public health; robust technological infrastructure
that is nimble and scalable; innovations and collaborations with
multiple sectors; and programs that address disparities during and
after the COVID-19 pandemic.
Question. Unfortunately, there is no question that the pandemic has
been challenging for many people--our nation has faced an unprecedented
mental health crisis and a rise in overdoses. CDC's provisional data
shows a 28 percent increase in overdose deaths in the 12-month period
ending in October 2020. More than 88,000 lives were lost to an overdose
during that period, the highest number of fatal overdoses ever recorded
in the U.S. in a single year, three-quarters of which were opioid-
related. Throughout my time on this Subcommittee, I made it a priority
to combat the opioid crisis and I'm concerned we have suffered a
significant setback. We need to better understand the impact that the
pandemic has had on overdoses and substance abuse.
What can you say about these trends in fatal overdoses and what are
some of the immediate needs to combat them?
Answer. Provisional 2020 data reveal that over 93,000 people died
of an overdose in 2020, a nearly 30 percent increase over 2019. The
recent increase in drug overdose mortality began in 2019 and continued
into 2020, prior to the declaration of the COVID-19 National Emergency
in the United States in March.
There are many factors that can be driving the increase in overdose
deaths including:
--The changing illicit drug marketplace and the wider availability of
illicitly manufactured fentanyl and fentanyl analogs,
--Co-use of illicitly manufactured fentanyl with other drugs such as
cocaine and methamphetamine, and
--Mixing of illicitly manufactured fentanyl into the drug supplies of
methamphetamine and cocaine
CDC's Overdose Data to Action (OD2A) funds health departments in 47
states, the District of Columbia, two territories, and 16 cities and
counties to obtain high-quality, comprehensive, and timely data on
fatal and nonfatal drug overdoses to inform prevention and response
efforts. To help curb this epidemic, Overdose Data to Action strategies
focus on enhancing linkage to and retention in substance use disorder
treatment, improving prescription drug monitoring programs,
implementing post-overdose protocols in emergency departments,
including naloxone provision to patients who use opioids or other
illicit drugs, and strengthening public health and public safety
partnerships, enabling data sharing to help inform comprehensive
interventions.
The President's Budget for fiscal year 2022 includes a requested
increase of $237.8 million for opioid overdose prevention and
surveillance. Immediate needs to combat the acceleration in overdoses
include:
--Expanding the provision and use of naloxone and overdose prevention
education;
--Expanding access to and provision of treatment for substance use
disorders;
--Intervening early with individuals at the highest risk for
overdose; improving detection of overdose outbreaks due to
fentanyl, novel psychoactive substances (e.g., fentanyl
analogs), or other drugs to facilitate an effective response;
--Continued partnerships with public safety to monitor trends in the
illicit drug supply, including educating the public that drug
products might be adulterated with fentanyl or fentanyl analogs
unbeknownst to users.
A comprehensive and coordinated approach from clinicians, public
health, public safety, community organizations, and the public must
incorporate innovative and established prevention and response
strategies, including those focused on polysubstance use.
Question. The Labor/HHS bill provides funding for opioid-related
programs at the CDC, and a particular area of focus addresses
infectious diseases associated with the opioid epidemic. Those
resources help strengthen our understanding of the full scope of the
burden of infectious diseases associated with substance use disorders.
As a result of the pandemic, many public health departments' staff that
would normally work on surveillance and prevention of infectious
diseases, such as hepatitis, have been detailed to work on the COVID
response.
What do we know about the impact of the pandemic on surveillance
and prevention of infectious diseases associated with the opioid
crisis?
Answer. The COVID-19 pandemic has deepened the opioid crisis and is
having a profound impact on the fight against infectious diseases
associated with this epidemic. We don't yet know the full impact but we
are concerned that the major disruptions in access to prevention
services and deferral of healthcare services during the pandemic may
result in more infections and lead to severe health consequences in the
long run. Deferral of healthcare services ultimately delays diagnosis
and treatment, leaving people living with Hepatitis C and/or HIV
unaware of their status and vulnerable to disease progression while
also increasing the risk of spreading the viruses. Available data from
CDC's funded programs also indicates that 50 percent of syringe
services programs (SSPs) have reduced operations and 25 percent have
closed further impacting opportunities for hepatitis testing and
linkage to care. The closures of these SSPs severely limited access to
vital hepatitis C virus and HIV prevention services, including
referrals to treatment services as well.
In October 2020, CDC released a health advisory about the
possibility of new injection-related HIV infections and outbreaks and
noted how prevention efforts could be hindered because of the COVID-19
pandemic. Many HIV and viral hepatitis program staff were reassigned to
support the COVID-19 response which further hindered prevention
efforts. In the context of the pandemic, ongoing delivery of core
public health services to address the injection drug use crisis and the
infectious diseases associated with this epidemic, like hepatitis C and
HIV are essential. CDC is committed to helping states build capacity to
combat both epidemics and will continue to provide guidance as we
address new and evolving challenges.
Question. In response to the COVID pandemic, states have received
billions of dollars in aid, with the intent of giving them maximum
flexibility to respond to their unique needs and challenges. Congress
passed five bipartisan emergency supplemental funding bills last year,
four of which included funding specifically for CDC activities totaling
$16.25 billion for the agency. The vast majority of the funding,
roughly 75 percent, is to support state and local public health
preparedness and response, laboratory capacity, and surveillance. It is
my understanding there is a sizable portion of unobligated funds
remaining from the bipartisan emergency supplemental bills. And now
there is even more funding provided as part of the American Rescue Plan
reconciliation bill for the same purpose. While it is important to know
how fast CDC is getting this funding into the hands of the frontline
responders on the state level, it is just as important to know if
they're spending the money.
What are the spend rates that CDC is seeing at the state level?
Answer. States have multiple funding sources, including
disbursements from the treasury, that are used for public health
purposes. The amounts and purposes vary greatly by state and it is not
possible to generalize about spend rates. Recipient cash drawdowns are
a lagging indicator of recipient performance because the recipient
draws down cash to reimburse at the time of, or after, they pay their
bills. In addition, as recipients have their own project plans and cash
management processes, cash drawn totals provide a high-level picture
for that recipient and are generally not comparable across a cohort of
recipients in the same program.
Question. What accountability do the States have to tell you how
they have used the funds?
Answer. Recipients regularly report on their use of funds and the
outcomes they achieved per the terms of the funding agreement by which
they are awarded the funds.
Question. Given the unprecedented volume of funding going out from
the CDC as a result of the partisan reconciliation bill--can you
explain CDC's decisionmaking infrastructure, process, and planning
mechanisms for deploying unprecedented sums of money in such a short
period of time? How does CDC plan for states and the public health
infrastructure to sustain these advancements when the supplemental and
mandatory funding runs out?
Answer. CDC is allocating funding to states based on the provisions
included in the statute. CDC uses funding mechanisms available to fit
the purpose outlined in the statute, and where needed, has developed
new ones.
The ability to respond to a public health emergency requires a
strong day-to-day public health system, supported by infrastructure
that is not highly segmented by disease, condition, or activity. In
addition to the COVID-19 pandemic, over the past 24 months, CDC has
also responded to diverse public health threats from E-cigarette or
Vaping Product Use-Associated Lung Injuries (EVALI), Ebola, complex
multi-state food-borne disease outbreaks, wildfires, and hurricanes.
Responding to the unique characteristics of each of these public health
emergencies has required deep scientific expertise to deploy a
specialized approach and called for a robust public health system with
world-class infrastructure nationwide to stop disease at its source.
Unfortunately, this recent history has revealed the effects of
inadequate public health infrastructure. Ongoing health disparities
made us as a nation more vulnerable to pandemics and large-scale public
health emergencies, as well as burdening large segments of our
population with chronic public health concerns. Additional investment
in both domestic and global public health infrastructure is needed as
proposed in the fiscal year 2022 Budget.
With investments requested in fiscal year 2022, CDC will begin to
address mission-critical gaps in public health infrastructure and
capacity nationwide. Transitioning from sporadic influxes of
supplemental funding tied to a specific emergency to flexible funding
that can prevent another crisis will strengthen the current public
health system. Flexible, sustainable investments in infrastructure and
capacity are critical for saving lives and averting economic losses
caused by public health emergencies and chronic public health problems.
In fiscal year 2022, CDC will prioritize funding to rebuild the most
critical public health infrastructure needed to safeguard the nation's
health and economic security.
Question. The Administration has placed an emphasis on addressing
health equity, especially as it relates to the pandemic response
efforts.
What trends are you seeing in rural communities right now with
regard to the pandemic?
Answer. Data continue to show the disproportionate impact of COVID-
19 on population groups, including people living in rural or frontier
areas. CDC's publication examining disparities in COVID-19 vaccination
coverage found COVID-19 vaccination was lower in rural counties (38.9
percent) than in urban counties (45.7 percent). These data are
available on the county tracker, which provides an integrated, county-
level view of key data for monitoring the COVID-19 pandemic in the
United States. It allows for the exploration of standardized data
across the country. The footnotes describe each data source and the
methods used for calculating the metrics. For the most complete and up-
to-date data for any particular county or state, visit the relevant
health department website.
Question. How does the CDC's health equity work account for the
needs of rural communities?
Answer. Rural areas face unique challenges both during the COVID-19
pandemic and when confronting ongoing public health challenges. The CDC
COVID-19 Response Health Equity Strategy, developed under the
leadership of the Chief Health Equity Officer Unit, affords a robust
platform from which CDC and its partners are pursuing deeper
engagements of diverse communities, stronger infrastructures to better
support data-driven action, and culturally responsive approaches
optimized for serving diverse, differentially impacted populations in
different areas, including rural and frontier populations. CDC has
provided historic funding to address health disparities, including
support for rural areas, as follows:
--$3.0 billion to strengthen vaccine confidence (awarded early April
2021): Funding will focus on reaching communities hit hardest
by the pandemic, including those in rural areas.
--$3.0 billion to ensure broad-based distribution, access and vaccine
coverage (awarded Jan. 2021): A minimum of 10 percent to
jurisdictions must be allocated for high- risk and underserved
populations, including rural communities.
--$2.25 billion to states and localities to address COVID-19 in
medically underserved communities including rural communities
and communities with large populations of racial and ethnic
minorities
Additionally, the Federal Retail Pharmacy Program continues to be
an important component in our commitment to address the
disproportionate and severe impact of COVID-19 on communities of color
and other underserved populations, including rural populations. From
February 10 to May 19, 2021, 46,811,020 vaccine doses had been
administered and reported by retail pharmacies across programs in the
U.S. A total of 21 retail pharmacy partners are participating in the
program, with more than 41,000 locations online and administering doses
nationwide.
CDC has numerous initiatives working to reduce disparities in rural
populations. A few examples include:
--Community Health Workers for Covid Response and Resilient
Communities (CCR) supports the training and deployment of
community health workers (CHWs) to response efforts and by
building and strengthening community resilience to fight COVID-
19 through addressing existing health disparities. Priority
populations are those with increased prevalence of COVID-19 and
are disproportionately impacted by long-standing health
disparities. Recipients to be announced at the end of August
2021.
--Racial and Ethnic Approaches to Community Health (REACH) program
works to reduce racial and ethnic health disparities, including
those found in rural communities. Interventions focus on proper
nutrition, physical activity, tobacco use and exposure, and
chronic disease prevention, risk reduction, and management.
--The Healthy Tribes Program funds tribal communities across the
country to strengthen connections to culture to promote healthy
lifestyles and reduce risk factors for chronic diseases. These
programs together support community-developed strategies that
work in rural settings to address the unique challenges that
contribute to health disparities for these communities.
--Scaling the National Diabetes Prevention Program in Underserved
Areas funds 10 national organizations to expand the reach of
the National Diabetes Prevention Program lifestyle change
program to underserved areas and populations, including hard-
to-reach rural regions of the US with fewer resources to
address health disparities. Priority populations include
Hispanic/Latino, African American, American Indian/Alaska
Native, and Asian American persons; Pacific Islanders; and
noninstitutionalized people with visual impairments or physical
disabilities.
Question. Dr. Walensky, as more Americans are vaccinated, there are
certainly going to be more ``breakthrough'' cases--individuals who test
positive for COVID-19 even after being fully vaccinated. This is to be
expected since no vaccine is 100 percent effective. What concerns me is
that while we're seeing breakthrough cases, for example the New York
Yankees reported a staggering number of breakthrough cases in the
spring, the CDC announced it will no longer track all breakthrough
cases.
Are we letting down our guard--should all COVID-19 cases continue
to be counted?
Answer. Despite the high level of vaccine efficacy, a small
percentage of fully vaccinated persons will develop symptomatic or
asymptomatic infections (i.e. breakthrough infections) with SARS-CoV-2,
the virus that causes COVID-19. The goal of national surveillance for
COVID-19 vaccine breakthrough infections is to identify unusual
patterns, such as trends in age or sex, the vaccines involved,
underlying health conditions, or which of the SARS-CoV-2 variants made
these people sick. To date, no unusual patterns in cases have been
detected in the data CDC has received.
Question. Can you explain why the change was made and exactly what
CDC is now tracking with regard to breakthrough cases?
Answer. State and local health departments report COVID-19 vaccine
breakthrough cases to CDC voluntarily. The number of COVID-19 vaccine
breakthrough infections reported to CDC likely are an undercount of all
SARS-CoV-2 infections among fully vaccinated persons. Reports may not
be complete and because not all infected persons get tested, not all
breakthrough cases will be identified. This is particularly true in
instances of asymptomatic or mild illness. The shift to focus on
hospitalized or fatal cases will help maximize the quality of the data
collected on cases of greatest clinical and public health importance,
while representative, scientifically valid data on vaccine
effectiveness comes from studies CDC is leading across the country.
Reporting vaccine breakthrough cases through national surveillance
is only one of the ways CDC measures COVID-19 vaccine effectiveness.
CDC continues to lead studies in multiple U.S. sites to evaluate
vaccine effectiveness and to collect information on COVID-19 vaccine
breakthrough infections from these sites regardless of clinical status.
For example, CDC is working with Emerging Infection Program (EIP) sites
in nine states to compare SARS-CoV-2 sequence data from vaccinated and
unvaccinated cases, regardless of clinical severity. CDC also is
working on more than 30 ongoing studies to assess vaccine
effectiveness, some of which include information on vaccine
breakthrough infections in patients with asymptomatic and milder
illness. Through these studies in various populations, locations, and
settings, CDC can obtain more representative, scientifically valid, and
complete information about these types of infections.
CDC is also using the Coronavirus Disease 2019 (COVID-19)-
Associated Hospitalization Surveillance Network (COVID-NET) to track
and analyze breakthrough infections. This population-based surveillance
system includes data on laboratory-confirmed COVID-19-associated
hospitalizations in 99 counties in 14 states, representing
approximately 10 percent of the U.S. population. COVID-NET cases are
hospitalizations occurring in residents of a designated COVID-NET
catchment area who are admitted within 14 days of a positive SARS-CoV-2
test. COVID-NET personnel collect COVID-19 vaccination status (doses,
dates administered and product) from state Immunization information
systems (IIS) for all sampled COVID-NET cases in 13 sites, which also
include information on clinical outcome. Some sites have expanded
collection of vaccination status to non-sampled cases, which were
included for analysis if all cases in a single month had vaccination
status available.
This strategic, deliberative approach will yield better information
on vaccine effectiveness and provide critical insight on cases of
greatest concern.
Question. Related, there is increasing concern about the public
health impact of long-term symptoms weeks or months after an individual
has had COVID-19.
What monitoring or tracking is the CDC undertaking with regard to
COVID ``long-haulers''?
Answer. CDC is spearheading rapid and multi-year studies to further
investigate post-COVID conditions (PCC), also known as ``long COVID''
or ``long-haul COVID.'' These studies will help us better understand
post-COVID conditions and how to treat patients with these longer-term
effects. For example, ongoing studies will follow patients for up to 3
years and provide information on the percent of persons who develop
post-COVID conditions, assess risk factors for development of post-
COVID conditions, and evaluate different virus strains and antibody
responses.
Question. How many long-haulers would you estimate are living with
post-COVID related symptoms?
Answer. At this time, we do not have a precise way to measure and
capture the prevalence of persons living with post-COVID-19 related
symptoms, but we know there are many people who are suffering from
this.
Currently, CDC and its Federal partners have proposed a new PCC
ICD-10 code and are looking at all considerations on how this may
impact the final version of this new code. The new ICD-code could
potentially be used for a range of conditions, including subsequent
chronic respiratory failure to help track and monitor people living
with PCC. CDC's National Center for Health Statistics (NCHS) presented
a proposal for public input to implement the code U09.9, post-COVID-19
condition, based on a proposed international classification of
diseases, tenth revision (ICD-10) code from the World Health
Organization (WHO) last year. This proposal is expected to move forward
after public input and may be implemented in October 2021 (as part of
the regular ICD-10 code process/timelines) to allow clinical data
systems and health insurers to adapt and fully implement it. We hope
this will provide us with a better estimate of those who may be living
with PCC.
Question. How does CDC plan to continue to monitor and track the
long-term impacts of COVID?
Answer. CDC is using multiple de-identified electronic health
record (EHR) databases to examine persistence of symptoms and incidence
of post-COVID conditions. CDC has also partnered with health systems to
perform in-depth medical record reviews, which can provide insight into
the patterns of health effects that patients are experiencing.
Question. Dr. Walensky, CDC has received a lot of criticism
throughout the pandemic. A lot of it is justified. And most of it
transcends political leadership at the agency. There are a lot of
lessons to be learned from what we did right and what we did wrong. As
I said in my opening statement, we did a lot right--so much so, in
fact, that we have three FDA authorized vaccines that are getting into
Americans' arms as we speak. But we also must recognize the missteps
when they happen as well. That is how we learn and how we become better
for the next public health emergency. Unfortunately, much of the
criticism about our pandemic response, that continues to this day,
revolves around the CDC. As Chair Murray and Senator Burr work on a
pandemic reform bill in the health authorizing Committee, I think it
would be a benefit to this Subcommittee to hear from you on these
issues as well. Can you please respond to the comments below:
Answer. First, CDC is risk adverse. I think that we have seen that
in several cases, from mask mandates for campers to discouraging travel
for the fully vaccinated.
Question. Second, CDC guidelines are impractical. The agency simply
doesn't issue guidelines that are clear and straightforward enough to
be useful. What I continually heard is that Federal guidance needs to
be practical for implementers on the ground or the American people to
follow it.
Answer. Since the early days of the pandemic, scientists at CDC
have been using evidence from systematic reviews and expert judgement
to develop guidance that informs various populations on how to slow the
spread of COVID-19 and protect their health and their communities. The
process and information communicated can be complex and evolves as our
understanding of the virus increases. CDC's group of multidisciplinary
stakeholders assesses the benefits and risks informed by data from the
field and issues evidence-based guidelines. State and local health
departments then decide how the research and guidance is implemented.
Question. Third, CDC has an entrenched bureaucracy that is
unwilling or unable to think big or implement on a large scale. The
perfect, and befuddling, example is why CDC didn't engage with private
sector partners like Abbott or Roche to commercialize their assay.
Testing was one of the early failures. Was this the reason why?
Further, at the outset, lab testing followed the flu model.
Asymptomatic spread requires significant testing, but this was low-
balled and kept in-house which could only produce about 100,000 tests
when what needed to happen was to engage the private sector labs to get
1-2 million higher volume throughput.
Answer. CDC aids and equips state and public health laboratories in
diagnostic testing for novel pathogens. When a new virus emerges or a
public health need for a new diagnostic tool arises, CDC may develop a
new diagnostic tool and, in partnership with state and local public
health partners and non-governmental organizations, strategize
distribution. This process is intended to fulfill needs within the
public health scope of outbreaks or new technologies. It is not
currently intended to replace or fulfill testing that may need to be
developed or distributed by commercial vendors to meet broader health
sector needs.
Furthermore, the EUA process for diagnostic (IVD) test development
and analysis/validation follows a predetermined framework at CDC, as
does deployment of the test after FDA authorization.
Question. Lastly, the Center structure at CDC is stove piped and
hampered the response. As a result, response efforts were locked into
the flu center, which treated COVID-19 like the flu--which spreads
symptomatically. Is this the reason we missed asymptotic spread?
Because we didn't have the right experts in charge or a CDC-wide body
responsible?
Answer. On January 7, 2020, the Director of the National Center for
Immunization and Respiratory Diseases (NCIRD) issued the directive
authorizing a Center Level Response, Novel Coronavirus (nCoV) 2019
Response, for the pneumonia outbreak in Wuhan, China in consultation
with the CDC Director. This Directive was effective January 6, 2020. As
the situation evolved, CDC escalated its response from the Center and
activated its Emergency Operations Center facilitating a CDC-wide
response on January 20, 2020.
When reports of asymptomatic spread first emerged, CDC's guidance
addressed the current circumstances. CDC proactively and aggressively
investigated evidence from the field, and updated its guidance
accordingly based on the best available data.
Question. Dr. Walensky, the Influenza Hospitalization Surveillance
Network (FluSurv-Net) is a population-based surveillance system that
collects laboratory confirmed influenza associated hospitalizations
from 14 states. The coverage area for FluSurv-Net is roughly 29 million
people, or 9 percent of the U.S. population. There is no site in
Missouri and the Midwest is not represented at all, except for Iowa.
How can the CDC accurately track an influenza outbreak without
real-time data from 36 states?
Answer. CDC's influenza surveillance systems are a collaborative
effort between CDC and its many partners in state, local, and
territorial health departments, public health and clinical
laboratories, vital statistics offices, healthcare providers, clinics,
and emergency departments. The system consists of complementary
components that capture virologic surveillance, outpatient illness
surveillance, hospitalization surveillance, and mortality surveillance.
This comprehensive surveillance infrastructure is used to identify when
and where influenza activity is occurring, determine which influenza
viruses are circulating, detect changes in influenza viruses, and
measure the impact influenza is having on outpatient illness,
hospitalizations, and deaths. Surveillance is performed continuously
throughout the year and data are presented in FluView, a weekly
influenza surveillance report, and FluView Interactive, an online
application which allows for more in-depth exploration of influenza
surveillance data, which are updated weekly.
Additionally, the HHS Protect Hospital Data reporting system
provides daily information on the number of patients hospitalized with
influenza-related and COVID-related illnesses from over 6,000 hospitals
in all 50 states and U.S. territories. This system provides situational
awareness of severe respiratory illness and local hospitalization
trends for influenza and COVID-19 on a daily basis that is beneficial
for monitoring severe illness during an outbreak.
Question. And how did the lack of real-time data stymy the response
to COVID-19?
Answer. COVID-19 highlighted the importance of real-time data
needed to get ahead and stay ahead of the disease. CDC must build on
initial investments and lessons learned from COVID-19 by investing in
the nation's public health infrastructure. The ability to respond to a
public health emergency requires a strong day-to-day public health
system, including efficient data sharing, and supported by
infrastructure that is not highly segmented by disease, condition, or
activity. With investment in fiscal year 2022, CDC will begin to
address mission-critical gaps in public health infrastructure and
capacity nationwide. Transitioning from sporadic influxes of
supplemental funding tied to a specific emergency to flexible funding
that can prevent another crisis will strengthen the current public
health system. Flexible, sustainable investments in infrastructure and
capacity are critical for saving lives and averting economic losses
caused by public health emergencies and chronic public health problems.
Question. Reports are already speculating that the next flu season
may be bad after a year of hardly any flu cases.
How concerned should we be that many Americans are left without an
immunity to flu--especially children--who may be more susceptible than
any other recent year?
Answer. A flu vaccine is the best way to protect children from flu.
CDC recommends that everyone 6 months and older should get a flu
vaccine every season. Annual vaccination is important to protect both
yourself and to provide protection for those who are more vulnerable to
serious flu illness, including children, older adults, and people with
certain chronic health conditions.
The flu can be dangerous for children. During the 2019--2020
season, nearly 200 flu deaths in children were reported to CDC in the
United States, which was the highest reported number of pediatric
influenza deaths on record. About 80 percent of those children were not
vaccinated. Last year, childhood influenza vaccination coverage is
estimated to have dropped 4.1 percentage points from 62 percent during
2019-2020 to 58 percent.
CDC is working diligently to support the vaccination of as many
Americans as possible during the upcoming influenza season. Vaccine
manufacturers have projected that they will supply 188 to 200 million
doses of influenza vaccine for the 2021-2022 season. CDC will continue
to emphasize the importance of influenza vaccination through targeted
communication outreach. CDC will build off its 2020-2021 communication
campaign, which was estimated to have been seen more than 5 billion
times. This year's media campaign will include population-wide outreach
and will have a special emphasis on targeting disproportionately
affected audiences, including people ages 40-64 with chronic medical
conditions, African American and Hispanic persons, essential workers,
pregnant women, and parents.
______
Questions Submitted by Senator Richard C. Shelby
Question. The Alabama Department of Public Health saw a delay in
the reporting of vaccine distributions upon the initial allocation of
vaccine allotments to states. Ultimately, there was not a delay in the
distribution of the vaccine, but in the reporting of administered
vaccines. In the last 15 months, Congress has appropriated $1.1 billion
to the CDC for the purpose of public health data modernization and
addressing public health data reporting issues that were experienced in
Alabama. In 2019, CDC stakeholders requested $1 billion over a ten-year
period to tackle public health data modernization, which CDC has
indicated is needed and Congress has far surpassed to this point. $500
million was appropriated through both the CARES Act and the American
Rescue Plan Act of 2021, and $50 million was appropriated for both
fiscal years 2020 and 2021 annual appropriations for the funding of
public health data modernization through the CDC.
Could you give a detailed description of how that $1.1 billion has
been used to date, who that funding has gone to (e.g., through
contracts, cooperative agreements, and grants), and for how much?
Please also provide a detailed plan for the remaining funds.
Answer:
ANNUAL APPROPRIATIONS
Table 1. Budget Plan for Annual Appropriations \1,2\
------------------------------------------------------------------------
Fiscal Year
Major Activity -------------------------------
2020 2021
------------------------------------------------------------------------
Partnering with State and Local Public $32.5M $32.5M
Health, Partners, and Health Care
Systems................................
Accelerating Public Health Data for $15.5M $15.5M
Action.................................
Sustaining Innovation................... $2 million $2 million
Total............................... $50 million $50 million
------------------------------------------------------------------------
\1\ Working Capital Fund and program support costs are spread across all
activities.
\2\ Amounts per activity are based on current information and may
require adjustment.
Data Modernization Base Funding
Congress recognized the need to modernize CDC's data systems and
provided funding in fiscal year 2020 dedicated specifically to data
modernization. DMI base funding is focused on strengthening and
sustaining the core foundational surveillance systems that state, local
and territorial jurisdictions use every day. These systems benefit all
of public health and serve as ``early warning signals'' for our biggest
threats--systems that handle emergency room visits, case reporting,
notifiable diseases, lab results, and death data. Investments to date
have laid the groundwork and spurred real progress, but much work
remains to be done.
In fiscal year 2020, CDC focused on solutions for the timely,
secure, and accurate flow of health data from electronic health
records, laboratories, and other primary data sources to state and
local jurisdictions and the multi-directional data flows between these
jurisdictions and CDC. The focus of these efforts has been on the
following:
--Expanded use of eCR and connectivity to Electronic Health Records
(EHR)
--Increasing the number of emergency departments and use of syndromic
and disease surveillance data through the NSSP
--Enhancing automated electronic laboratory reporting (ELR) and
implementation of Electronic Test Orders and Results (ETOR) at
clinical and public health laboratories
--Implementing improvements to birth and death reporting in NVSS
--Modernization of disease reporting through NNDSS and of states'
National Electronic Disease Surveillance System (NEDSS) Base
System (NBS)
CDC has continued to reimagine what its core surveillance systems
could deliver in fiscal year 2021. CDC works closely with public health
partners to reduce their reporting burden and make sure everyone has
the capacity to connect with each other. The pandemic drove huge leaps
in electronic case reporting (eCR), with thousands of healthcare
facilities now exchanging automated, real-time health information. All
50 states, D.C., and 11 large local jurisdictions are now capable of
receiving COVID-19 electronic case reports, up from only a handful of
jurisdictions in late 2019. The National Vital Statistics System (NVSS)
expanded its modernization community and began delivering provisional
COVID-19 death data and new data on excess deaths. Currently, 67
percent of deaths are reported electronically in less than 10 days, up
from 7 percent in 2010. CDC has dramatically improved the quality of
laboratory report data received by public health through nationwide use
of standardized messaging with Electronic Laboratory Reporting (ELR),
with 56 jurisdictions reporting lab data directly to CDC, up from zero
in 2019. Data from 70 percent of all U.S. emergency departments is
reported to CDC through the National Syndromic Surveillance Program
(NSSP), with 75 percent of emergency department data received in less
than 24 hours of a visit. As a result, more early warning signals from
systems that track emergency department visits and notifiable diseases
were and are being captured.
In fiscal year 2020, approximately $22.5 million was distributed
through a cooperative agreement to 58 awardees, including states,
cities, and territories, with an average award of $391,417. These funds
supported specific strategies, activities, and outcomes to improve
health information systems infrastructure, workforce development, and
public health laboratories. States have used these funds to conduct
needs assessments, strengthen technical and informatics skills,
streamline changes to surveillance systems, and identify a lead person
in each jurisdiction to support data modernization.
CDC is continuing to improve core public health data systems,
enhance data science and informatics workforce capabilities across the
public health systems, improve interoperability and innovation through
adoption of new standards and approaches for public health reporting
such as Fast Healthcare Interoperability Resources (FHIR) standards,
and support ongoing data modernization at CDC and with its partners.
Our focus in fiscal year 2021 has been on providing technical
assistance to state and local jurisdictions to leverage progress made
at the Federal, state, and local levels on electronic case reporting
(eCR) and Electronic Test Orders and Results (ETOR), as well as other
core systems and processes for data exchange. Technical assistance is
being provided by CDC and through a cooperative agreement with public
health partners like the Association of Public Health Laboratories
(APHL) and the Council of State and Territorial Epidemiologists (CSTE).
These partners are providing technical assistance to jurisdictions
focused on improving data sharing, accelerating use of shared decision
support services, data science upskilling of the public health
workforce, and developing and increasing use of standards to improve
quality and timeliness of reported data. Focus on continuing to improve
core public health data systems, enhance data science and informatics
workforce capabilities across the public health systems, improve
interoperability and innovation through adoption of new standards and
approaches for public health reporting (such as FHIR standards) and
support of ongoing data modernization at CDC and with its partners
CDC also provided funding through a cooperative agreement to three
tribal health entities to focus on three activity areas: augmenting
workforce development and capacity, identifying and deploying specific
enhancements in public health data and health information systems, and
employing shared services to improve data quality, exchange, and
management. CDC has provided funding to tribal entities in fiscal year
2021 to focus on the improving access to data, modernizing
infrastructure for data collection and analysis, and expanding
workforce data skills.
To keep CDC at the forefront of innovative, data-driven public
health solutions, we are strengthening skills for a state-of-the-art
data science workforce by supporting workforce development to assure
capable data scientists and informatics-skilled staff are available to
state, territorial, local, tribal, and Federal public health agencies.
In fiscal year 2020, CDC completed a pilot cohort of team training
through the Data Science Upskilling (DSU), which included 79 unique
learners on 18 teams. DSU is a new model of team training using
experiential learning tailored to agency priorities. Teams include both
CDC staff and fellows from the Public Health Informatics Fellowship
Program utilizing curated online courses and in-depth, boot-camp-style
training on topics like machine learning. Team projects align with
agency DMI priorities, CDC's winnable battles, or COVID-19 response.
CDC also funded the Council of State and Territorial Epidemiologists
(CSTE) to implement a similar program, Data Science Team Training
(DSTT).
DSTT was designed as a replica to CDC's Data Science Upskilling
program, with modifications to better meet state, tribal, local, and
territorial, needs. Training activities began in January 2021 with 20
teams and 86 learners. There is representation from a mix of state,
local, tribal, and territorial health departments.
cares act funds
Together with base funding, the Coronavirus Aid, Relief, and
Economic Security (CARES) Act extended and accelerated CDC's data
modernization goals for the nation. CARES funding focuses on
infrastructure, innovations, and connecting systems and data sources.
Rather than discrete, one-off projects or a narrow focus on individual
capacities, we have looked at the entire surveillance and data
ecosystem and identified the areas most in need of investment and
modernization. While COVID-19 is the priority, the end goal of DMI is
to create lasting, adaptable solutions that will make public health
more responsive and resilient in the future.
CARES funding is being invested across three major areas:
--Data Sharing across the Public Health Ecosystem
--Modernizing critical tracking capabilities and core surveillance
systems
--Extending data lakes and services that support electronic
laboratory reporting and immunization information
--Expanding the type, variety, and quality of data available to CDC
programs and STLT
--Automating the flow of data from electronic health records and
other sources
--CDC Systems and Service Enhancements for Ongoing Data Modernization
--Expanding enterprise cloud services to bring in and use large
datasets from partners in new ways
--Expanding CDC's enterprise data hub, orchestration, warehouse,
lake, analytics, and visualization capacity
--Building a state-of-the-art data science workforce
--Ensuring open and accessible data while protecting privacy and
security
--New Standards and Approaches for Public Health Reporting
--Implementing new standards and approaches, such as FHIR across the
public health ecosystem
--Assessing policy/legal barriers to sharing data, including STLT
data
Our work focused on data sharing across the public health ecosystem
includes modernizing critical tracking capabilities and surveillance
systems, such as the National Healthcare Safety Network (NHSN), Public
Health Environmental Tracking Network, the National Electronic Injury
Surveillance System-All Injuries Program (NEISS-AIP), and the National
Vital Statistics System (NVSS). We are also rapidly expanding
electronic case reporting (eCR) from healthcare to public health. We
have rapidly extended data lakes and services that support electronic
laboratory reporting and immunization information, including the
creation of a new immunization data lake that is now actively receiving
and making available 3.1M administration records per day. Funding has
also supported the creation of the Pan Respiratory Surveillance
Initiative, informing our knowledge of molecular surveillance, viral
evolution, and helping track trends in emerging variants.
Enhancements to CDC systems and service enhancements for ongoing
data modernization include deploying cloud-based technology to bring in
and use large data sets from partners in new ways, while also providing
highly scalable data analytic and visualization capabilities. This is
already strengthening our data sharing capabilities. For example, we
modernized data sharing with Homeland Security to ingest daily
international passenger arrival contact tracing information, parse it,
and provide it overnight to states through a secure, cloud-based file
transport system for STLTs to ingest into their individual tracking
systems. In the past year, the percentage of usable data has improved
to over 95 percent and time to transmit to STLTs has decreased from
days to overnight. Ongoing work to expand CDC's enterprise data hub,
orchestration, warehouse, lake, analytics, and visualization capacity
makes us better able to support modernization project needs across the
agency. We have streamlined identity proofing and access management,
use of enterprise code repositories, and enterprise security and code
complexity scanning. The CDC Data Hub actively continues to ensure that
analytics, including machine learning and artificial intelligence, are
enabled in cloud-based data pipelines. At the same time, we have
Initiated training opportunities to build a state-of-the-art data
science workforce, including CDC's Data Academy, which has delivered
more than 1000 hours of free training.
Our modernization efforts include developing new standards and
approaches for public health reporting. We are preparing CDC and our
STLT and healthcare partners to implement technologies and standards
that make systems interoperable and help these systems ``speak the same
language.'' Federal policies and advancements in technologies are
opening doors to make new connections for exchanging public health
data, and a major focus is on implementing Fast Healthcare
Interoperability Resources, or ``FHIR,'' across the public health
ecosystem. FHIR application programming interfaces (APIs) can help
public health to access detailed and timely data from EHRs while
lowering burden on and delivering greater value to data providers. We
are also working closely with jurisdictions and research partners to
innovate toward FHIR-based interoperability at every level. This will
give us more complete data and surveillance capabilities nationwide.
Our goal is to take what works and scale nationwide, through pragmatism
and collaboration to realize significant benefits to the way we use and
share data across all of public health.
Table 2. Budget Plan for CARES Act Appropriations \1,2\
------------------------------------------------------------------------
Funding Levels
Thematic Area for Fiscal Year
2020-2021
------------------------------------------------------------------------
Data Sharing Across the Public Health Ecosystem....... $140.55M
CDC Systems and Service Enhancements and Ongoing Data $120.62M
Modernization........................................
New Standards and Approaches for Public Health $13.83M
Reporting............................................
Additional fiscal year 2020 funding for Emergency $41.44M
Operations Center public health surveillance
activities...........................................
Future fiscal year 2022-2023 funding.................. $183.56M
TOTAL............................................. $500 million
------------------------------------------------------------------------
\1\ Working Capital Fund and program support costs are spread across all
activities.
\2\ Amounts per activity are based on current information and may
require adjustment.
american rescue plan funds
CDC appreciates further appropriations in data modernization
awarded through The American Rescue Plan Act. Where possible CDC is
evaluating recent investments made in national data infrastructure and
working with states to understand the gaps that still exist and
barriers to modernizing to further drive the best practices for
efficient and effective data modernization across the public health
ecosystem. Planning is currently underway to apply ARP data
modernization resources to drive a flexible, responsive, and modern,
response- ready data infrastructure.
______
Questions Submitted by Senator Jerry Moran
Question. In February, the CDC issued an order requiring face masks
on conveyances and at transportation hubs. Last week, you updated your
guidance for fully vaccinated individuals, saying they can stop wearing
masks indoors and outdoors. However, the CDC has not taken any steps to
update the February transportation order.
When can we expect such an update?
Answer. While those who are fully vaccinated may resume many
activities without wearing a mask, the travel environment presents a
unique set of circumstances based on the number and close interaction
of travelers (both vaccinated and unvaccinated). Traveling on public
transportation increases a person's risk of getting and spreading
COVID-19 by bringing people in close contact with others, often for
prolonged periods. Staying 6 feet away from others is often difficult
on public transportation conveyances. People may not be able to
distance themselves by the recommended minimum of 6 feet from other
people seated nearby or from those standing in or passing through the
aisles on airplanes or buses, for example.
Correct and consistent use of masks on public transportation
conveyances and at transportation hubs protects travelers and workers,
enables safe and responsible travel during the pandemic, and helps to
reduce the spread of coronavirus disease 2019 (COVID-19).
CDC will update the Order and other recommendations as more people
get vaccinated, as rates of COVID-19 change, and as additional
scientific evidence becomes available.
Question. Given the different risk levels of COVID transportation
across the transportation network, for instance traveling on public
transportation verses operating a freight locomotive, can we expect
different guidance?
Answer. CDC will continue to evaluate the requirements of its Order
and determine whether other changes are warranted by examining
characteristics like the transportation environment as well as indoor
and outdoor locations. CDC will update the Order and other
recommendations as more people get vaccinated, as rates of COVID-19
change, and as additional scientific evidence becomes available.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. There are two FDA-approved buprenorphine products for the
treatment of moderate to severe chronic pain. Both buprenorphine-based
products have been classified by the U.S. Drug Enforcement
Administration (DEA) as Schedule III meaning they have less abuse and
addiction potential compared to Schedule II drugs like oxycodone,
fentanyl, and oxymorphone. Furthermore, buprenorphine provides an
important safety advantage as it is the only opioid with a demonstrated
ceiling effect on respiratory depression, which is what typically leads
to death in an opioid overdose. In addition, there are several
buprenorphine-based products approved to treat opioid addiction. This
means that one of the same drug compounds that help millions of
Americans curb their addiction to illicit and prescription opioids can
also be used effectively to treat chronic pain with a lower chance of
addiction, abuse and overdose. However, it's my understanding that the
CDC's Guideline for Prescribing Opioids for Chronic Pain, which was
published in 2016, doesn't include any language about the benefits of
Schedule III buprenorphine products, even though they have less
potential for addiction and abuse, for the treatment of chronic pain.
Instead, the Guideline recommends starting opioid therapy with
immediate release Schedule II opioids, which have been shown to have
higher rates of addiction, abuse and overdose.
Do you know why the Guideline doesn't differentiate between
Schedule II and Schedule III opioids and recommend the use of Schedule
III opioids given their enhanced safety profile and lower risk of
abuse, addiction and overdose?
Answer. The evidence reviews informing the 2016 Guideline found
evidence of increased risks from extended-release/long acting (ER/LA)
full agonist opioids but did not identify other differences in safety
or effectiveness by type of opioid, including by schedule. Therefore,
there was no evidence on which to base recommendations to use different
types of opioids (except recommendations on ER/LA vs. short-acting
opioids).
Question. Can you provide an update on the process and timing of
the CDC's efforts to update the Guideline? Do you expect the updated
Guideline to consider DEA scheduling and recommend prescribers begin
opioid therapy with Schedule III drugs, when clinically appropriate,
before advancing to a Schedule II Drug?
Answer. CDC funded the Agency for Healthcare Research & Quality
(AHRQ) to conduct systematic reviews of the scientific evidence that
has been published since the Guideline's release in March 2016. These
reviews are the following:
--Noninvasive Nonpharmacological Treatment for Chronic Pain (An
Update)
--Nonopioid Pharmacologic Treatments for Chronic Pain
--Opioid Treatments for Chronic Pain
--Treatments for Acute Pain: A Systematic Review
--Acute Treatments for Episodic Migraine
Based on AHRQ's completed reviews, CDC has determined that an
update to the Guideline and an expansion of the Guideline to certain
acute conditions is warranted.
On December 4, 2019, the Board of Scientific Counselors of the
National Center for Injury Prevention and Control (BSC/NCIPC)
established the Opioid Workgroup (OWG). The OWG will report to the BSC/
NCIPC, a Federal advisory committee. The primary purpose of the OWG is
to review the updated draft Guideline for opioid prescribing (as
prepared by CDC) and to develop a report that will provide the
workgroup's findings and observations about the draft GL to the BSC/
NCIPC.
The OWG began reviewing a draft Guideline for opioid prescribing
(as prepared by CDC) in March 2021. The OWG met for a total of 11 times
since October 2020 and developed a report of findings and observations
about the draft Guideline update (prepared by CDC). The OWG presented
its findings at the July 2021 BSC/NCIPC meeting. The BSC/NCIPC will
then review the OWG's report and provide recommendations for CDC to
consider as part of the Guideline update process.
It is anticipated that a revised Guideline will be posted in the
Federal Register for a 60-day public comment in late 2021, which will
provide a critical opportunity for diverse input from the public.
Release of a final updated Guideline is anticipated to occur in
late 2022.
On opioid therapy--there are very limited clinical trial data
comparing safety and efficacy of partial agonist buprenorphine with
full agonist/schedule II opioids for chronic pain. In order to ensure
that the updated guideline would be informed by available clinical
evidence on types of opioids, CDC asked AHRQ to specifically address,
in its evidence review on opioids for chronic pain to inform CDC's
guideline update, the following questions on effectiveness and safety
of opioids by type of opioid:
``Key Question 1. Effectiveness and Comparative Effectiveness . . .
. b. How does effectiveness vary depending on . . . (4) the
type of opioids used (e.g., pure opioid agonists, partial
opioid agonists such as buprenorphine or drugs with mixed
opioid and nonopioid mechanisms of action such as tramadol or
tapentadol)?''
``Key Question 2. Harms and Adverse Events . . . . b. How do harms
vary depending on . . . (5) the mechanism of action of opioids
used (e.g., are there differences between pure opioid agonists
and partial opioid agonists such as buprenorphine or drugs with
opioid and nonopioid mechanisms of action such as tramadol and
tapentadol) . . . ?''
The AHRQ evidence review published in 2020 found very limited
evidence on comparative safety or effectiveness of opioids for chronic
pain by type of opioid. Please see the report for additional detail,
which can be found at https://effectivehealthcare.ahrq.gov/sites/
default/files/pdf/opioids-chronic-pain.pdf.
CDC is considering all findings from the AHRQ evidence reviews in
developing updated recommendations.
SUBCOMMITTEE RECESS
Senator Murray. The committee we will next meet in Dirksen
562, Wednesday, May 26 at 10 a.m., for a hearing on the Biden
Administration's Budget Request for the National Institutes of
Health.
Thank you very much.
[Whereupon, at 11:50 a.m., Wednesday, May 19, the
subcommittee was recessed, to reconvene at 10 a.m., Wednesday,
May 26.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2022
----------
WEDNESDAY, MAY 26, 2021
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:01 a.m., in room SD-562, Dirksen
Senate Office Building, Hon. Patty Murray (chairwoman)
presiding.
Present: Senators Murray, Reed, Shaheen, Schatz, Baldwin,
Murphy, Manchin, Blunt, Shelby, Graham, Moran, Kennedy, Hyde-
Smith, Braun, and Rubio.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
STATEMENT OF FRANCIS S. COLLINS, M.D., PH.D., DIRECTOR
ACCOMPANIED BY:
DIANA BIANCHI, M.D., DIRECTOR, EUNICE KENNEDY SHRIVER NATIONAL
INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY
AND INFECTIOUS DISEASES
GARY GIBBONS, M.D., DIRECTOR, NATIONAL HEART, LUNG, AND BLOOD
INSTITUTE
ELISEO PEREZ-STABLE, M.D., DIRECTOR, NATIONAL INSTITUTE ON
MINORITY HEALTH AND HEALTH DISPARITIES
NED SHARPLESS, M.D., DIRECTOR, NATIONAL CANCER INSTITUTE
BRUCE TROMBERG, PH.D., DIRECTOR, NATIONAL INSTITUTE OF
BIOMEDICAL IMAGING AND BIOENGINEERING
OPENING STATEMENT OF SENATOR PATTY MURRAY
Senator Murray. Good morning. The Senate Appropriations
Subcommittee on Labor, Health and Human Services, Education and
Related Agencies will please come to order.
Today, we are having a hearing on the Biden
Administration's fiscal year 2022 Budget Request for the
National Institutes of Health. Senator Blunt and I will each
have an opening statement, and then I will introduce our
witnesses. And after the witness testimony, Senators will each
have 5 minutes for a round of questions.
Before we begin, I do want to walk through the COVID-19
safety protocols that are in place today. And again, I really
want to thank all of our clerks and everyone who has really
worked hard to get this set up and help us all stay safe and
healthy. So, thank you to them.
For today, we are going to be conducting this hearing
following similar COVID protocols to what we have used in the
past. Committee members are seated at least 6 feet apart. Some
Senators are participating by videoconference. However, I do
expect that this will be our final hybrid hearing, and we will
be able to return to regular, in-person hearings at our next
hearing.
Consistent with CDC guidance, those who are fully
vaccinated do not need to wear a mask, though they may still
choose to do so. And while we are unable to have the hearing
fully open to the public or media for in-person attendance,
live video is available on our committee website. And if you
are in need of accommodations, including closed captioning, you
can reach out to the committee or the Office of Congressional
Accessibility Services.
As of today, almost half of U.S. adults are fully
vaccinated. And while we have a lot of work left yet to do to
reach communities who still cannot get vaccines and reassure
people who still have many questions about them, we can see the
light at the end of the tunnel. And, I really want to thank all
of our witnesses, especially Dr. Collins and Dr. Fauci, for
putting in long hours and putting science first.
Where we are at today is a testament to the tireless work
scientists at NIH have been doing to study this disease and how
we can best fight it, and oversee clinical trials for vaccines
and therapeutics and more, to ensure they are safe and
effective. And, of course, as our witnesses know, our
historically fast progress in fighting COVID-19 and developing
safe and effective vaccines was actually years in the making.
The pace of discovery we have seen this past year was made
possible by research into mRNA vaccines we funded in response
to Ebola and other viruses, and biomedical research enterprise
that has been built over decades to become one of the most
cutting edge in the world.
This should be an important reminder when it comes to
biomedical research. You can never fully predict how the
discoveries of today will prepare you for the challenges of
tomorrow. That is why you have to build the robust research
enterprise and recruit diverse, world class talent, and make
sure scientists can do their work free from political
interference.
And President Biden's budget, which proposes over $40
billion for NIH (National Institutes of Health), the largest
increase in the agency's history, will go a long ways towards
making sure we can continue to prioritize this. This budget
will reinforce our work to fight COVID-19, along with many
other diseases and disorders that threaten families in my home
State of Washington, or Missouri, or across the Country.
It includes funding to improve treatments for addiction and
substance use disorders, and funding to aid the fight against
cancer, Alzheimer's disease, and rare diseases families across
the Country are grappling with.
President Biden's budget request will also fund research to
help us study the health effects of climate change, which may
be increasing the number of infectious disease outbreaks;
identify solutions to gun violence, which continues to claim
tens of thousands of lives each year in this Country; and root
out the health inequities in our Country, which are undermining
the health of people of color, people with disabilities, rural
communities, those paid low incomes, and more.
The President has also proposed $6.5 billion for a new
initiative--the Advanced Research Projects Agency for Health.
Like the defense initiative it is inspired by, ARPA-H is
envisioned as breaking the mold for how cutting-edge research
is conducted, speeding up the development of medical treatments
by funding innovative projects. I am interested to hear more
about how it can add to NIH's work and operate as something
truly distinct from its other traditional, biomedical research
programs.
Of course, at the end of the day, innovation is not just
driven by new programs and new investments. It is driven by
people, which is why with as much as we invest in NIH each
year, and as important as its work to its families, our
families, we cannot afford to have this agency's potential
limited or its success threatened by bias, discrimination,
harassment, or assault in the workplace.
Unfortunately, we know that in the biomedical research
community, the prevalence of researchers of color is too low,
and the prevalence of sexual harassment is too high. These are
real problems with real consequences for biomedical research
and the people who do the lifesaving work we are all
benefitting from today.
I commend NIH for the efforts it has taken on both of these
fronts so far. NIH has done work to examine barriers to
diversity among its researcher ranks and how its own practices
have reinforced structural biases that allow discrimination to
persist. But, more work remains to tear down barriers and
create lasting change.
And when it comes to sexual assault, Director Collins, I am
glad you have taken some forceful action to address the problem
among the NIH workforce, but NIH must do more to use its
enormous influence with the research community to enforce
change in the Nation's universities and research institutions.
I expect NIH to continue building on its efforts so far to
remove racism, discrimination, and harassment from research,
and I will continue to follow up on that progress.
Finally, as proud as we all are of our Nation's biomedical
research institutions, we do not invest billions of dollars in
biomedical research out of pride, nor do we invest in them to
help pharmaceutical companies make astronomical profits. We do
it to bring new treatments, cures, and hope to people across
the Country and across the world. It is important that we never
lose sight of this because even the most brilliant miracle cure
can only save people if they can actually get it.
Just as I hope to work with my colleagues on both sides of
the aisle to make lifesaving investments in biomedical research
like those proposed in the President's budget, I also hope we
can work together to bring down the cost of healthcare,
especially for prescription drugs; keep working towards
universal health coverage; and bring the cures we are investing
in to the families who need them.
With that, I will turn it over to Senator Blunt for his
remarks.
STATEMENT OF SENATOR ROY BLUNT
Senator Blunt. Well, thank you, Chair Murray. I appreciate
having this hearing today and appreciate being able, again, to
start this process with you as we did last week on our first
hearing.
I am certainly glad that Dr. Collins and the Institute
directors are here with us today. I think two of the directors
are testifying before the committee for the first time, and,
so, welcome to the two of you. And this is a helpful
relationship for us, and hopefully for you.
Certainly, the challenges we have faced over the past year
have been unanticipated and significant. I think the global
pandemic reinforced the importance of the National Institutes
of Health. In less than a year, NIH was able to take this novel
coronavirus and help develop two FDA (Food and Drug
Administration)-authorized vaccines, two FDA-authorized
therapeutics, and 16 rapid diagnostic tests, including the
first FDA-authorized point-of-care diagnostic test for COVID-19
to combat its spread and its effects.
A year ago, when we would have had a similar discussion,
one of the big topics would be, why can't we get enough tests?
NIH stepped up and really played a big role in seeing that we
had enough tests. We have not heard that discussion for a long
time. And that does not mean that millions of tests are not
being taken every day. It just means we figured out at this
committee and NIH to be part of meeting that need.
It was revolutionary to watch NIH work, but it did not just
happen. In a time of crisis, during shutdowns, during social
distancing, dealing with a disease that has never been seen
before, the system and its nationwide grantees were able to use
their expertise and infrastructure to, again, develop tests,
treatments, and vaccines. Our research infrastructure was
tested like never before and, in my opinion, it succeeded in
remarkable ways.
I believe there are really three reasons for that. First,
in the past 6 years, this committee and the Congress, in a
bicameral, bipartisan way have prioritized and invested in NIH.
Within that 6-year timeframe, funding for medical research
increased by almost $13 billion, or nearly 43 percent over that
6 years after a decade at virtually level funding. This
investment encouraged young scientists, young researchers, and
mid-career researchers that were leaving the field before that
to stay in the field. And, with your insistence, Dr. Collins,
some of that money every time was set aside to be sure that it
was going to first-time grantees.
We were able to shore up the research infrastructure across
the Country and provide research into mRNA, an idea that had
never produced a vaccine before and, of course, became the
foundation for the two principal vaccines that were developed
very much with the involvement of NIH.
Our ability to pivot so quickly and so successfully to
fighting COVID-19 could not have been accomplished had we
stayed at the funding levels we were at 7 years ago. The buying
power was not where it needed to be. Young researchers were
leaving the field. Tough budgetary decisions meant that people
were not only getting their applications rejected at
significant levels; they just, frankly, stopped making a lot of
applications. That is not your problem, by the way, today.
Second, at the height of the pandemic, Congress gave the
Department of Health and Human Services significant funding and
flexibility to create Operation Warp Speed. It was successful
in developing two FDA-authorized COVID-19 vaccines and
commercializing another with the help of NIH because we united
in our effort to make that happen.
One of the things we did was to really invest in vaccines
that we did not think were certain to work, but thought were
likely to work, and that meant that vaccines were available
when they got FDA authorization rather than months after they
got FDA approval. Because of that, fully half of all adults
have been vaccinated now in the United States as we work toward
a bigger number than that.
We pushed private industry and worked with private industry
in ways we had not before. I have said at the time, one way to
win the horse race is to bet on all the horses. And I think to
a great extent we did in the vaccine effort, bet on all the
horses we thought had a chance to finish the race, and it made
a difference.
Finally, one of the most important lessons learned from the
pandemic is the value of having the Federal Government, on
occasion, as a more active partner in research and development
instead of just a sponsor. The ambitious speed and goals that
pushed private companies to research, develop, and manufacture
a COVID-19 vaccine, along with what we did in testing, really
created the kind of breakthroughs we needed.
RADx and Warp Speed, I think put us in a different place
than we would have been 2 years ago in thinking about how we
can look at some of our research efforts in another way. That
is why I want to work with the Administration to support the
ARPA-H initiative. This will be a new institute, or is proposed
to be a new institute, and I think that is what should be the
case. They will have the flexibility and tools necessary to
both nimbly and innovatively respond to both the next pandemic
and also some of the big health issues we face today.
This is a critical moment in a rapidly changing healthcare
world. Finding those things that the kind of Warp Speed, Shark
Tank, RADx relationship could enhance in cancer, in
Alzheimer's, in every disease where there is an opportunity;
where we see that moment and know that this is something that
does not necessarily call for a 5-year research grant, but some
sort of partnership different than that that moves toward a
real conclusion sooner than we might otherwise be able to do
that.
ARPA-H should not do what the other institutes do, but it
should do what the other institutes cannot do in a crosscutting
way that goes throughout the institutes, looking for
opportunities, frankly, in the other institutes where there is
a breakthrough moment that we could look at differently. I
think we can help fill gaps here that otherwise would not be
filled and look forward to that discussion.
Now, also, as someone working with Senator Murray for the
last 6 years to increase the funding and the focus in what NIH
has been doing, we clearly want to be sure that this somehow
does not take away from the solid research that proves so
effective in getting us ready for what we just saw.
So, Dr. Collins, I look forward to working with you and
Chair Murray and the Administration in making ARPA-H a reality.
I think the moment is ready for that. I think because of what
has happened in the last 2 years, NIH is ready for that, and
look forward to the discussion today.
[The statement follows:]
Prepared Statement of Senator Roy Blunt
Thank you, Chair Murray. I appreciate Dr. Collins and the other
Institute Directors for being here today.
The challenges we have faced over the past year in a global
pandemic reinforced the importance of the National Institutes of
Health.
In less than a year, NIH was able to take this novel coronavirus
and develop two FDA-authorized vaccines, two FDA-authorized
therapeutics, and 16 rapid diagnostic tests, including the first FDA-
authorized point-of-care diagnostic test for COVID-19, to combat its
spread and effects.
This was revolutionary, and it didn't happen without decades of
preparation.
In a time of crisis, during shutdowns and social distancing, for a
disease never seen before, the NIH and their nationwide system of
grantees were able to use their expertise and infrastructure to develop
tests, treatments, and vaccines for COVID-19. Our research
infrastructure was tested like never before, and it succeeded. And I
believe there were three key reasons behind this success.
First, for the past six years, this Committee and Congress have
prioritized and invested in NIH. Within this timeframe, funding for
medical research increased by $12.85 billion, or nearly 43 percent,
after having spent the previous decade at virtually level funding.
This investment encouraged young and mid-career scientists in the
field, who often have the most novel and innovative research ideas,
shored-up the research infrastructure across the country, and provided
research into mRNA, which is the foundation for two of the COVID-19
vaccines.
Our ability to pivot so quickly and so successfully to fighting
COVID-19 could not have been accomplished had this Committee let NIH
funding stagnate for another decade, dragging down its buying power,
and letting young researchers leave the field. Making the tough
budgetary decisions necessary to prioritize the NIH paid off.
Second, at the height of the pandemic, Congress gave the Department
of Health and Human Services significant funding and flexibility to
create Operation Warp Speed. It was successful in developing two FDA-
authorized COVID-19 vaccines and commercializing another, with the help
of NIH, because it united the federal government, private companies,
and researchers around a common goal.
The reason that we have been able to fully vaccinate half of all US
adults is because there was a deliberate strategy in the last
Administration to focus and provide funding for any COVID-19 vaccine or
therapeutic that had the likelihood to work. We took financial risks to
manufacture vaccines as the development process was still underway.
We pushed private industry to innovate their own approaches. And we
forever changed the drug approval process. As I have said before, the
way to win a horse race is to bet on all the horses. That is what this
Committee and the previous Administration did.
Finally, one of the most important lessons learned from the
pandemic is the value of having the Federal Government become a more
active partner in research and development, instead of just a sponsor.
The ambitious speed and goals that pushed private companies to
research, develop, and manufacture a COVID-19 vaccine through Operation
Warp Speed demonstrated that active collaboration in public-private
partnerships, in conjunction with significant funding, are game
changers in creating scientific breakthroughs.
Now we must learn from these lessons. There is an opportunity to
build upon Operation Warp Speed and NIH's RADx diagnostic testing
program to leverage public-private partnerships to dramatically
accelerate the development and approval of new treatments and
technologies. What two years ago would have been termed risky and
financially unpalatable now is possible.
And that is why I want to work with this Administration to support
the ARPA-H initiative. This will be a new Institute that will have
flexibility and tools necessary to nimbly and innovatively respond to
both the next pandemic and also to some of the biggest health issues
Americans face today, like cancer and Alzheimer's disease.
ARPA-H should do what other NIH Institutes cannot. It needs to be
cross-cutting throughout all the NIH Institutes and collaborative both
internally with NIH and HHS and externally with partners. It needs to
be innovative. And it should help fill the gaps we clearly saw during
the pandemic between basic science and commercialization of COVID-19
vaccines and therapeutics.
Simply put, there are aspects of NIH research that could move much
faster outside the traditional NIH grant cycle. The NIH peer review
process is the gold standard, but we also need to recognize that it
doesn't work for all research at all times.
I look forward to working with you, Dr. Collins, and you, Chair
Murray, on making ARPA-H a reality.
It will take collaboration between the Administration, NIH, and
Congress. But as we work toward a new Institute to accelerate the
application and implementation of health discoveries, we must make sure
that basic science is not abandoned. ARPA-H should not be the shiny new
toy we all focus on, especially not to the detriment of the NIH
research community as a whole.
If there is one lesson we must take from this pandemic, it is that
our nation's success depends on the medical research infrastructure
across this country supported by the NIH. Now is not the time to
abandon it. Now is the time to make it even stronger.
Thank you.
Senator Murray. Thank you very much, Senator Blunt.
I will now introduce our witnesses.
Dr. Francis Collins is the director for the National
Institutes of Health.
Dr. Diana Bianchi is the director of the Eunice Kennedy
Shriver National Institute of Child Health and Human
Development.
Dr. Anthony Fauci is the director of the National Institute
of Allergy and Infectious Diseases.
Joining us virtually is Dr. Gary Gibbons. He is the
director of the National Heart, Lung and Blood Institute.
Dr. Eliseo Perez-Stable is the director of the National
Institute on Minority Health and Health Disparities.
Dr. Ned Sharpless is the director of the National Cancer
Institute.
And, finally, Dr. Bruce Tromberg is the director of the
National Institute of Biomedical Imaging and Bioengineering.
So, Dr. Collins, we will turn to you for your opening
remarks.
SUMMARY STATEMENT OF DR. FRANCIS S. COLLINS
Dr. Collins. Thank you, Chair Murray and Ranking Member
Blunt and distinguished members of the subcommittee. I am
honored to be here today with my colleagues representing the
National Institutes of Health, the NIH.
I could spend hours describing the exciting work the
President's budget is proposing for NIH, including major
investments to address impacts of the COVID-19 pandemic, reduce
health disparities in maternal mortality, improve mental
health, broaden approaches to pain and opioid addiction, and
establish a bold, new agency within NIH called ARPA-H.
But, in our brief time together, it is also important to
emphasize how steady funding increases that you have provided
to NIH, starting well before the pandemic, made it possible for
NIH to meet the challenges of the pandemic and to prepare for
what comes next.
Often at these hearings, I share a story of a patient whose
life has been saved by NIH research, but in this uniquely
challenging year, it is hard to single out any one person. In
fact, all of the more than 160 million Americans who have
received COVID-19 vaccines as of today are success stories made
possible by the sustained investment that this committee made
years ago to basic biomedical research.
The road to these mRNA vaccines actually started back in
the 1960s when the function of messenger RNA was first
understood. These messengers carry instructions from the cell's
DNA manual to produce the proteins that do the work. Now, for
vaccines, we knew that certain proteins, like the spike
proteins on the coronavirus, could spur an immune response.
But, might it be safer and just as effective to use the RNA,
the codes for those spike proteins, to instruct the patient's
body to produce them? And it took a lot of obstacles to
surmount to get there over more than 20 years, but we are blown
away by how well it works.
In parallel, other NIH-supported scientists, including some
at our own Vaccine Research Center, learned that locking those
spike proteins into the right configuration could make an even
better vaccine. So, when COVID hit, we knew exactly what to do,
but we needed the help of the American people enrolling in
clinical trials to finish the job. To facilitate that, NIH
opened a dialogue with communities disproportionately affected
by COVID to ensure that they had access to the vaccine trials.
The Community Engagement Alliance, or CEAL, c-e-a-l,
Initiative built on some existing, long-term partnerships with
trusted leaders in underserved communities to engage directly
on trial enrollment, and later with hesitant individuals on
issues related to vaccine safety and efficacy.
We were able to use the enrollment techniques we learned in
the large, longitudinal studies, such as All of Us, that you
have championed. The result is that all Americans can look at
the major vaccine trials and see that people like them were
included.
While the vaccines were in early trials, the world was
clambering for rapid diagnostics to understand and manage our
risks. Members of this committee, most notably Senator Blunt,
asked what NIH could do to ramp up innovation. And thanks to
your support, and using a novel Shark Tank approach, NIH took
on a new role as a venture capitalist through the Rapid
Acceleration of Diagnostics, or RADx program.
Today, there are 33 novel testing platforms helping perform
just today, millions of tests daily, due to RADx. This program
demonstrated the remarkable innovations that are possible when
NIH brings together experts in engineering, business, and
manufacturing to fund big ideas.
Now, the President's budget proposes a major investment to
build on this momentum the Advanced Research Projects Agency
for Health, or ARPA-H. This new agency within NIH will catalyze
novel strategies to speed transformational and innovative
ideas, ideas such as simple blood tests to detect free-floating
DNA or protein markers that signal a cancer is growing
somewhere in the body; a micro needle patch that delivers a
vaccine to hard-to-reach communities in the mail; using an
innovation funnel to recruit, test, and scale up new
technologies for ambulatory blood pressure measurement with the
potential to transform the management of hypertension.
These are just a few of the bold ideas that ARPA-H could
tackle, but they are not science fiction. With standard
approaches, well, they might happen in a decade or two. With
ARPA-H, we believe it could take half that time.
The President believes that with your help, we can learn
from the lessons of pandemic and transfer this scientific
momentum into big improvements in the health of all Americans.
I do, too.
My colleagues and I would be pleased to answer your
questions.
[The statement follows:]
Prepared Statement of Francis S. Collins, M.D., Ph.D., Diana W.
Bianchi, M.D., Anthony S. Fauci, M.D., Gary H. Gibbons, M.D., Eliseo J.
Perez-Stable, M.D., Norman E. Sharpless, M.D., and Bruce J. Tromberg,
Ph.D.
Good morning, Chairwoman Murray, Ranking Member Blunt, and
distinguished Members of the Subcommittee. I am Francis S. Collins,
M.D., Ph.D., and I have served as the Director of the National
Institutes of Health (NIH) since 2009. It is an honor to appear before
you today.
First, I want to thank this Subcommittee for your commitment to
NIH, which allowed the biomedical research enterprise to respond
quickly to the greatest public health crisis in our generation over the
past year. We mounted vigorous research efforts to understand the viral
biology and pathogenesis of the coronavirus disease 2019 (COVID-19),
develop vaccines in record time, support and commercialize diagnostics
at the point of care, and test therapeutics for both outpatient and
inpatient settings. This work is far from finished.
The President's Discretionary Request proposes budget authority of
$51 billion for NIH in fiscal year (FY) 2022. The Biden Administration
places great emphasis on research and development in general. At NIH in
particular, the Request proposes to build on the successes of pandemic
era research and to put the research enterprise to work on some of our
Nation's most persistent and perplexing health challenges, including
cancer, Alzheimer's disease, opioid use disorder, health disparities,
maternal mortality, HIV/AIDS, gun violence, climate change, and other
areas with major implications for our Nation's health.
First and foremost, the President's Request proposes $6.5 billion
to establish the Advanced Research Projects Agency for Health--ARPA-H
to drive transformational innovation in health research and speed
application and implementation of health breakthroughs. ARPA-H will
tackle bold challenges requiring large scale, cross-sector
coordination, employing a non-traditional and nimble approach to high
risk research, modeled after DARPA in the Department of Defense. To
achieve this, ARPA-H will invest in emergent opportunities by
conducting advanced systematic horizon scans of academic and industry
efforts, leveraging novel public-private partnerships, recruiting
visionary program managers, and using directive approaches that provide
quick funding decisions to support projects that are results-driven and
time-limited. Potential areas of transformative research driven by
ARPA-H include: the use of the mRNA vaccines to teach the immune system
to recognize any of the 50 common genetic mutations that drive cancer;
development of a universal vaccine that protects against the 10 most
common infectious diseases in a single shot; development of wearable
sensors to measure blood pressure accurately 24/7; and leveraging of
artificial intelligence technology to advance care for individual
patients and improve detection of early predictors of disease.
ARPA-H represents the kind of transformative idea for biomedical
research that only comes along once in a long while. Our confidence
that NIH is ready has been greatly advanced by our experience in
addressing the COVID-19 pandemic--developing vaccines in record time,
establishing an unprecedented public-private partnership on
therapeutics that has made it possible to test more than a dozen
possible therapeutics in rigorous trials, and building a venture
capital model for assessing SARS-CoV-2 diagnostic technologies that has
yielded millions of daily tests in just months.
But while we begin to imagine a life after COVID-19, we must
acknowledge that there are COVID-related impacts that we have yet to
understand and address, including the full impact of the pandemic on
children. Children were largely spared from COVID-19 but for some
children, exposure to the COVID-19 virus led to Multisystem
Inflammatory Syndrome in Children (MIS-C), a severe and sometimes fatal
inflammation of organs and tissues. The Eunice Kennedy Shriver National
Institute of Child Health and Human Development (NICHD) is leading a
multi-institute initiative known as the Collaboration to Assess Risk
and Identify loNG-term outcomes for Children with COVID (CARING for
Children with COVID), which will assess both short-term and long-term
effects of MIS-C and other severe illness related to COVID-19 in
children, including cardiovascular and neurodevelopmental
complications.
For many Americans, this pandemic and its related socioeconomic
effects have had an overwhelming impact on their mental health. Prior
research on disasters and epidemics has shown that in the immediate
wake of a traumatic experience, large numbers of affected people report
distress, including new or worsening symptoms of depression, anxiety,
and insomnia. To aid in mental health recovery from the COVID-19
pandemic, NIH will continue to focus on research in this area. This
will be done, in part, by utilizing participants in existing cohort
studies, who will be surveyed on the effect of the pandemic and various
mitigation measures on their physical and mental health.
The COVID-19 pandemic has brought into sharp focus the dramatic
health disparities that exist across the American population. In
addition, the Nation has been shaken by the killing of George Floyd and
other attacks on people of color, forcing a recognition that our
country is still suffering the consequences of centuries of racism. NIH
will continue to address these disparities, specifically through
research managed by the National Institute on Minority Health and
Health Disparities (NIMHD), the National Heart, Lung, and Blood
Institute (NHLBI), the National Institute of Nursing Research (NINR)
and the Fogarty International Center (Fogarty).
NIMHD looks to better understand the human biological and
behavioral mechanisms and pathways that affect disparity populations,
better understand the long-term effects of disasters on health care
systems caring for populations with health disparities and research
focusing on the societal-level mechanisms and pathways that influence
disease risk, resilience, morbidity and mortality. NINR and Fogarty
both look to better understand and reduce rural health disparities in
low-income counties in the southern United States, support nursing
science focused on racial, ethnic, and socioeconomic health
disparities, with the goal of closing the gap in health inequities and
increase health disparity research in low and middle income countries.
In addition to the core health disparities research, the
President's Request puts an additional specific focus on maternal
morbidity and mortality (MMM), which disproportionately affect specific
racial and ethnic minority populations. Black and American Indian/
Alaska Native individuals are two to four times more likely to die from
pregnancy-related or pregnancy-associated causes compared to white
individuals. Furthermore, Black, Hispanic and Latina Americans, Asian,
Pacific Islander, and American Indian/Alaska Native individuals all
have higher incidence of severe maternal morbidity (SMM) compared to
white individuals. The Implementing a Maternal Health and Pregnancy
Outcomes Vision for Everyone (IMPROVE) initiative supports research on
how to mitigate preventable MMM, decrease SMM, and promote health
equity in maternal health in the United States.
As the climate continues to change, the risks to human health will
grow, exacerbating existing health threats and creating new public
health challenges. Major scientific assessments document a wide range
of human health outcomes associated with climate change. While all
Americans will be affected by climate change, underserved populations
are disproportionately vulnerable. These populations of concern include
children, the elderly, outdoor workers, and those living in
disadvantaged communities. NIH is poised to lead new research efforts
to investigate the impact of climate on human health, with the goal to
understand all aspects of health-related climate vulnerability.
Therefore, the President's Request includes a $100 million increase for
research on the human health impacts of climate change.
The FY 2022 President's Discretionary Request makes a major
additional investment to address the opioid crisis. The crisis of
opioid misuse, addiction, and overdose in the United States is a
rapidly evolving and urgent public health emergency that has been
exacerbated by the coronavirus pandemic. Since the declaration of a
public health emergency for COVID, illicit fentanyl use and heroin use
have increased, and overdoses in May 2020 were 42 percent higher than
in May 2019.
The use of opioids together with stimulants, such as
methamphetamine, is increasing; and deaths attributed to using these
combinations are likewise increasing. Taking note of these trends, FY
2021 appropriation language expanded allowable use of Helping to End
Addiction Long-term (HEAL) funds to include research related to
stimulant misuse and addiction. Identifying how opioids and stimulants
interact in combination to produce increased toxicity will enhance our
ability to develop medications to prevent and treat comorbid opioid and
stimulant use disorders and overdoses associated with this combination
of drugs.
Finally, I'd like to take a moment to thank this Subcommittee for
its recognition over the last two years that America's continuing
leadership in biomedical research requires infrastructure and
facilities that are conducive to cutting-edge research. With your
support, we will break ground in the near future on a new Surgical,
Radiological, and Laboratory Medicine division of our Clinical Center,
which will replace severely outdated and deteriorating operating suites
and lab space with state-of-the-art facilities. NIH continuously works
to ensure that the buildings and infrastructure on its campuses are
safe and reliable and that these real property assets evolve in support
of science--but NIH's backlog of maintenance and repair is now nearly
$2.5 billion. The President's FY 2022 Discretionary Request includes
$250 million to make progress on reducing this backlog and requests
flexibility for Institutes and Centers to fund construction, repair,
and improvement projects.
COVID-19 compelled us to perform a stress test on biomedical
research enterprise. The enterprise performed nobly. We found what
worked, and also identified barriers we hadn't fully appreciated
before, and invented new ways around them. The President's FY 2022
Discretionary Request is a roadmap for how to build on the successes of
research, address our gaps, and apply our insights to the most
important problems we face as a nation. With your support, the future
is filled with opportunity. My colleagues and I look forward to
answering your questions.
Senator Murray. Thank you very much, Director Collins. I
have to say, I have always loved your success stories. They are
usually really beautiful. But, I will say, I think many of us
in this room are grateful to be your success story this time.
So, thank you.
We will now begin our 5-minute rounds of questions, and Dr.
Collins, I will start with you.
As you just talked about, the President's budget includes
$6.5 billion to create the ARPA-H within NIH that is modeled
after DARPA. DARPA is a small, $3.5 billion agency that is
composed mostly of program managers and empowered to push the
limits of their disciplines and shape some milestone-driven
breakthrough technologies in short 3- to 5-year stints.
Given that the nature of NIH's work is different, relying
on a peer review system or multi-year grants that is
traditionally risk-adverse, where progress is often measured in
decades, how do you envision ARPA-H fitting into the NIH
ecosystem?
ARPA-H STRUCTURE
Dr. Collins. Senator, it is a great question. I think you
are right that much of what NIH does requires this kind of
careful, deliberative, investigator-initiated, hypothesis-
driven research, and that is going to be the mainstay of what
we do going forward. That has been the success story of NIH for
many decades.
But, there are opportunities, as we have seen happen during
COVID, such as the need to develop diagnostics in a hurry, to
develop vaccines in a hurry, that are not really amenable to
that approach, where you need to have program managers that are
empowered to move things swiftly and have the flexibility and
the resources to do so. And that is the DARPA model. We have
studied that closely, and we do think that there are projects
in biomedicine now that would be greatly advantaged by that.
That is not the typical peer review process that may take a
year from the idea to the first award. With RADx, we made those
first awards 5 days after the Congress gave us the budget for
it, and that played out really well.
So, we want to incorporate that mindset, and we want to
bring on perhaps a hundred of these program managers, give them
the opportunity to build the kind of collaborative ventures
that include such organizations as small businesses that might
otherwise not be likely to write an NIH grant.
Ride herd over these things carefully so that if they are
not doing well, they get basically stopped immediately. We
expect there will be failures--this is high risk--but identify
the areas of greatest opportunity. And every Institute at NIH
is now coming forward saying, I have at least five ideas of
what I would like to do with ARPA-H that I cannot do right now.
So, this should not be seen as competing with the
Institutes. It is going to be a synergistic relationship that
will allow us to do things otherwise that would take a very
long time.
Senator Murray. Okay. Well, you have said that it should be
within the office of the director. In that structure, how would
decisions be made about what projects to fund?
Dr. Collins. So, we will need to hire a director for ARPA-
H, who will need to be a visionary person, and the idea is to
bring on somebody who is not probably going to be doing this as
their long-term career, but maybe for one term, 5 years, with
one possible renewal.
That person will be very much engaged then in bringing
onboard these very creative program managers who have to make a
pitch about what kind of projects they think are worth
investing in and convince the director that that is the case.
And, then, they are given the flexibilities to go out and find
the right partners and see what can happen. But, that is all
going to be done in a way that is quite nimble. It is not going
to involve our traditional peer review process.
Senator Murray. Okay.
STRUCTURAL RACISM AND HEALTH EQUITY
Dr. Perez-Stable, your career has really focused on
improving the health of communities of color and underserved
populations. And NIH recently released a $30 million funding
opportunity to study the impact of structural racism and
discrimination in order to promote health equity and eliminate
health disparities. Can you talk to us a little bit about what
more can NIH, and particularly NIMHD (National Institute on
Minority Health and Health Disparities), be doing to address
those issues, and what would be the benefit of making
additional investments?
Dr. Perez-Stable. Thank you, Senator Murray, for that
question. So, first of all, we had to recognize that structural
racism could be operationalized as a research construct and not
just an organizational construct, and we went through a
workshop and scientific reflection on this. I think the moment
earlier this year for all of the NIH Institutes and Centers
agreed that this was an area that we needed to move on and
advance more quickly in the research side. And, so, we had a
commitment from all the institutes that do this, although NIMHD
was leading it from the beginning.
We believe that two areas are susceptible for improvement.
One would be the healthcare setting, where I think through
interventions at the structural, as well as the clinician and
the patient level will help. And, also, in promoting healthy
communities so that we can have easier access to green space,
to healthy food, accessible healthcare in community health
centers.
These are two areas that we believe are susceptible for
improvement, although we will depend on our scientific
community to promote and submit ideas that will be reviewed and
hopefully funded within fiscal year 2022.
Senator Murray. Okay. Thank you very much. I look forward
to working with you and hearing more about that.
Senator Blunt.
Senator Blunt. Thank you, Chairman.
ARPA-H FUNDING LEVEL
Dr. Collins, on the ARPA-H budget request, $6.5 billion,
one part of the question will be, how do you think that number
was arrived at, and is that a realistic number to commit in
year one?
And two, our concern would also be that we do not get in a
position that--we have already given NIH $6.5 billion and level
fund everything else. I do like the President's $2.5 billion. I
am sure you could figure out how to spend more than that in the
other institutes. That is pretty close to the average of the
last 6 years from our committee. I would certainly like to stay
at least at that level.
But, how do you think those two numbers compete with each
other? And how do you feel about actually being able to commit
$6.5 billion in that first fiscal year of ARPA-H?
Dr. Collins. That is a great question, Senator, and we have
thought a lot about it. I am pleased the President's budget
proposes that this would be 3-year money because, obviously,
you are going to start from a standing start whenever the
budget actually gets approved for fiscal year 2022. We hope
that will be September 30th, right? Well, it might not be. So,
at any rate, we would then really be benefitted by being able
in that first year to stretch those dollars over a little bit.
I do think we could, with a hundred program managers,
readily come up with a number of projects that would fit within
that envelope on an annual basis. But, I hear what you are
saying about a concern because I have heard it also that this
might in some way compromise the interest of the Institutes. I
guess I would look at it a different way, though.
As I said earlier, every one of the Institutes is coming
forward with great ideas about how they would like to use ARPA-
H. They think of this as an augmentation of their capabilities,
not a subtraction. And, so, they will be feeding ideas into
this and have a lot to do about how those are chosen. So, even
though the base number that is being proposed, $2.5 billion for
the ICs (NIH Institutes and Centers), may sound like a sort of
average one, in terms of the science they can do, ARPA-H is
going to add to that.
Senator Blunt. All right. Thank you.
ARPA-H AND CANCER RESEARCH
Well, Dr. Sharpless, one of the things the President, of
course, talks about in this issue, in this topic, is more
rapidly moving toward ending cancer. Obviously, we want to do
that. We also want to make the point that that is not the only
thing that ARPA-H would be focused on, nor would it just be
cancer or Alzheimer's. But, on that topic, how do you envision
the ARPA-H role in cancer research and what might you be able
to do with ARPA-H that you are not able to do in the
traditional restraints of the National Cancer Institute?
Dr. Sharpless. Thank you for the question, Senator Blunt.
It is great to be testifying in front of this committee again.
Good to see you virtually, at least, today.
Yes, as the President has said, ending cancer as we know it
is a top domestic priority for this Administration. We are
obviously, the cancer research community, is galvanized by this
notion and very excited.
I think, as you know, the National Cancer Institute does
some things really well. You know, we fund basic foundational
science very well. We can do clinical trials quite well. But,
there are some areas where we are challenged, where we have
struggles, and I think the scale and nimbleness and ability to
interact with industry is very appealing about ARPA-H for
certain kinds of cancer projects.
I think a good example of that is this blood-based cancer
detector technology that Dr. Collins mentioned in his opening
statement where you can, you know, find cancers at a very early
stage in otherwise asymptomatic, healthy people, and that could
have a profound effect on cancer mortality.
So, you know, getting up a huge trial of that technology as
quickly as possible is the kind of thing that I think would be
a good fit for ARPA-H.
Senator Blunt. Okay. Thank you, Dr. Sharpless.
RADX PARTNERSHIPS
Dr. Tromberg, let me see if I can get one more question in.
I think what you were part of at RADx is one of the reasons
that gives me real optimism about new kinds of relationships
that we might develop at ARPA-H. But, would you talk just a
little bit about RADx and how that partnership continued right
through the entire process of these companies that you were
choosing to invest money with, going ahead and making the first
home-based test, and I think producing well over two million
tests every day now, in addition to the tests that would have
come through the regular process?
Dr. Tromberg. Yes. Thank you so much, Senator Blunt, and
thank you for your question and for your generous support of
the RADx program.
The bioengineering-technology community has formed
partnerships all across the government. That has included
working with BARDA, FDA, DOD (Department of Defense), CDC
(Centers for Disease Control and Prevention), HHS (Department
of Health and Human Services), and the White House Testing
Board. More than 900 scientists are working across government,
academia, and the private sector in a very unique way to make
this work.
And, as you have mentioned, if we fast-forward to now,
about 1 year later, we now have 33 RADx-supported companies
that have increased the Nation's testing capacity by more than
300 million new tests, and there have been 23 new FDA
authorizations. And we have really changed the dialogue from
laboratory testing of symptomatic folks to over-the-counter,
widely available tests, point-of-care tests that are accessible
to all. Greater choice and greater capabilities. And this has
really happened because of all of these partnerships that we
formed, the accelerated innovation.
We have brought out new technologies. About 20 percent of
our portfolio actually--not many people know about--has been
based in nanoscience and nanotechnology.
Senator Blunt. Good.
Dr. Tromberg. So it has been a tremendous surge for
innovation.
Senator Blunt. Thank you, Doctor.
Thank you, Chairman.
Senator Murray. Yes. Senator Reed.
Senator Reed. Thank you very much.
I want to welcome all the panelists and thank them for
their distinguished service to the Nation, particularly during
this difficult and challenging COVID pandemic.
Dr. Collins, one of the things that is becoming
unfortunately and painfully obvious is the increase in
suicides, and this is very disturbing. And we are concerned,
also, about the impact of COVID-19 on accelerating, perhaps,
that phenomenon.
SUICIDE PREVENTION
So, the question I would have is, what research is NIH
doing on suicide prevention so that we can recognize the
warning signs, better communicate with friends and family, and
also give healthcare providers more insight? I am told that
many suicide victims visit emergency rooms frequently before
their suicide and those signs are not picked up. So, your
comments would be appreciated.
Dr. Collins. Well, I appreciate the question, Senator, and
it is a source of great concern and obviously great heartache
for the way in which this is taking a toll amongst people
across our Nation, and certainly at a time where mental health
issues have been even further heightened by all the stresses of
COVID-19. One can see this also becoming even more of a threat
to people who have lost hope.
NIH is deeply engaged in trying to understand ways to
prevent this terrible outcome, and the National Institute of
Mental Health has in fact invested in a number of new
initiatives as a result of that concern.
One that I would point to that has turned out to be a
pretty encouraging development is the recognition that the drug
Ketamine, which is used in anesthesia and sometimes used as a
party drug, unfortunately. It also turns out to have benefits
for people with serious depression, including people with
suicidal ideation. Now approved by FDA, and the drug
Esketamine, this is now available and it is being used in those
acute situations of acute suicidal threat.
You also mentioned that many people who are on the brink do
end up visiting healthcare facilities. We have worked hard to
try to make sure that this idea of having a screening tool that
was used in emergency rooms for individuals who are there, even
if they do not appear to be there for psychiatric reasons, gets
used to identify, particularly with adolescents, whether they
might be in a situation of contemplating self-harm.
On top of that, certainly NIMH is investigating other means
of treating depression, and also thinking hard about other
interventions that might be beneficial here in terms of
cognitive behavioral therapy combined with pharmacotherapy to
try to assist those individuals who are in this difficult
place. But, it is a terribly difficult problem.
I will say, it is interesting, but it is not necessarily
that encouraging, the actual suicide rate, as best we know, in
the course of the last year has not gone up. It has actually
gone down slightly, and that has tended to be the case in
national crises before. But, what I worry about is what happens
when we seem to be getting past the crisis, is there a pent up
backup there that might in fact result in an even greater risk
in the coming months.
I would be glad to give you more information. I am sure Dr.
Gordon would, as well, in terms of all the things that we are
doing.
Senator Reed. Thank you very much.
LONG COVID
Very quick question to both--to Dr. Fauci. The long haul
COVID-19 is beginning to trouble a lot of people. They never
seem to be able to recover from it and recurrences. What
attention are we paying to that issue?
Dr. Fauci. Thank you for that question, Senator. We are
paying a considerable amount of attention to it. In fact, we
have a program to the tune of $1.15 billion, looking at
developing cohorts of individuals so that we can study them for
the incidence, the prevalence, underlying pathogenesis, and, if
possible, if we can find this out, anything that we can do from
an intervention. So, the NIH is taking this very seriously.
Thank you.
Senator Reed. Thank you very much.
I have to commend Dr. Sharpless for his efforts on
childhood cancer. I was teamed up with Senator Capito. We
passed the Childhood Cancer STAR Act. We have been funding it,
thanks to the Chairwoman, at $30 million a year, and I want to
commend NIH on its renewed emphasis on childhood cancer, not
only treatments, but also gathering data about these victims as
they age so that we can see if there is any interventions that
we can use later on. So, thank you, Dr. Sharpless, and thank
you, panelists. Thank you very much.
Senator Murray. Thank you. Senator Graham.
Senator Graham. Thank you, Madam Chairman.
VACCINE DEVELOPMENT
The vaccine, developing the vaccine as fast as we did, what
is your biggest takeaway, Dr. Collins? How did we do that? And
how can we do it again if we have to?
Dr. Collins. It is really important to look and see that
this was built upon decades of research in basic science that
many people might have said would not probably end up being as
relevant as it turned out to be.
Senator Graham. So, all of our money in the past paid off
here, right?
Dr. Collins. Absolutely. This committee, and then the
Congress, especially over the course of the last 6 years where
you have increased the NIH support by 40 percent, has made it
possible for us to do a lot of things that otherwise we would
still not have been able to start. So, yes, it is all built
upon that foundation.
Senator Graham. Do you feel like the budget request being
made is enough to continue to build on what we have done?
Dr. Collins. I am very supportive of the President's budget
request, as you might expect I would be. And I am particularly
excited about this new proposal of ARPA-H, a new component of
NIH that would give us kind of a DARPA attitude that we could
bring to projects that are waiting for that kind of
opportunity.
Senator Graham. Well, I just hope we can memorialize what
we did to get the vaccine out so quickly.
GLOBAL VACCINE DISTRIBUTION
The developing world--Dr. Fauci, one thing I worry about is
getting the vaccine out into the developing world, particularly
Africa. What can we do better in that regard? And why should
we?
Dr. Fauci. Well, first of all, the answer to your second
question, which is very relevant, Senator, is why should we?
And the reason we should is that a global pandemic requires a
global response. And even though, as you well know from the
numbers, we are doing extremely well in this Country--we now
have over 60 percent of adults having at least one dose, and
about almost 50 percent of the adult population in this Country
fully vaccinated.
However, even if we get this pandemic under control, which
I believe we will within a period of a few months, there is
always the danger, when you have viral dynamics in other parts
of the world, for the generation of variants that might
actually undermine the protectiveness of the vaccines that we
have.
Senator Graham. So, it is in America's interest to get the
vaccine out to as many people as possible?
Dr. Fauci. It is absolutely to our interest. I believe--not
only do I think it is a humanitarian, moral responsibility, but
it is in what I call enlightened self-interest for us to do
that.
ORIGIN OF COVID-19
Senator Graham. So, let's talk about our enlightened self-
interest for a moment. Has there ever been a pandemic that we
know of that started in a laboratory somewhere?
Dr. Fauci. To our knowledge, no.
Senator Graham. Okay. If this were in fact a breach of
protocols in China, if it did come out of a lab, that would be
a first for the world; is that right?
Dr. Fauci. I believe so. There was a situation with an
influenza where there was a suspicion that it might have
escaped from a laboratory in Russia.
Senator Graham. But this----
Dr. Fauci. But that has never been validated or confirmed.
Senator Graham. So, have we found any animals that carry
COVID-19 that could have been the source of the transmission to
humans thus far?
Dr. Fauci. Thus far, not. I mean, if what you are referring
to, Senator, is an intermediate host----
Senator Graham. Right.
Dr. Fauci [continuing]. We know clearly, for example, with
SARS-CoV-1 that a bat virus went into a civet cat, which then
transmitted it into the human population. With MERS, it was a
bat to a camel to human.
The intermediate host, if there is one, has not yet been
found.
Senator Graham. And we have been looking for that
intermediate host; is that fair to say?
Dr. Fauci. That is fair to say, sir.
Senator Graham. At what point in time would it become more
likely it came from the lab if we do not find an intermediate
animal host? How much longer?
Dr. Fauci. I do not think we can give a time element on
that, Senator, for the simple reason we still have not yet
confirmed what the host is from Ebola. We know that Ebola jumps
from an animal reservoir to human, and it has been many years
now since the original Ebola outbreaks, and we have not yet
nailed that down.
Senator Graham. But we believe that Ebola did not come from
a lab?
Dr. Fauci. Yes.
Senator Graham. Okay.
Dr. Fauci. Yes.
Senator Graham. So, I guess my point is, who should look,
what should we be doing to make sure we find out how it
started?
Dr. Fauci. Right.
Senator Graham. And finally, what should be the
consequences to any country, China included that allowed this
to happen? What should the world expect of a country if they in
fact allowed this virus to come from one of their labs through
negligence?
Dr. Fauci. Well, first of all, when you said, who should,
you know, the WHO (World Health Organization) did what they are
referring to now as phase one of an investigation, which they
felt was not completely adequate, as you know. You have heard
me and Dr. Collins and others in the Administration calling for
a continuation of the investigation.
I do not think I can comment on your second question. It
would have to be the circumstances under which something like
that happened, if indeed it happened.
Senator Graham. Well, just very briefly--I know my time is
out--I think we should send a clear signal to China--seems to
be a source of a lot of pandemics--that if this did occur in
the lab, expect something to happen because if we do not, we
are just going to reinforce this in the future. And what that
something is, I am open-minded to, but I am closed-minded to
the idea of doing nothing.
Senator Murray. Thank you. Senator Shaheen.
Senator Shaheen. Thank you, Madam Chairman, and thank you
to you, Dr. Collins, and everyone at NIH for all of your hard
work over the last very difficult year and for everything else
you are doing.
ARPA-H AND DIABETES
As you are aware, diabetes is one of the most expensive and
pervasive of our chronic diseases, and I was pleased that in
the authorization at the end--re-authorization at the end of
the year, we funded the Special Diabetes Program for 3 years
and the work that is being done to advance treatment for Type
1.
But, can you talk about this new ARPA-H agency and to what
extent it might be looking at ways to help address diabetes?
Dr. Collins. I would love to, and thank you for the
question, Senator. This is the hundredth anniversary year of
the discovery of insulin, so we have come a long way in those
hundred years, but we are not where we really need to be to say
we have conquered this one.
ARPA-H, because of its ability to tackle problems in a
team-oriented, nimble way, offers us some new opportunities
here. Certainly, one of the ones that the Diabetes Institute
has been promoting to me of late, sending me ideas, is to
transform the way that we actually develop and test
therapeutics, shouldn't we at this point be able to come up
with therapeutics for diabetes that do not require injections.
A totally new approach to how we would treat this disease.
Another one that I am excited about, and I know you have
done a lot of encouragement about this, is the artificial
pancreas.
Senator Shaheen. Right.
Dr. Collins. And we have made real progress there, Senator.
But, I think we could go a lot faster if we had this
coordinated, ARPA X kind of attitude brought to this, both for
artificial pancreases that are built on engineering and sort of
a feedback loop that gives insulin when it needs to, but maybe
even more so the ones that built upon the patient's own stem
cells that can be converted into that.
Senator Shaheen. And how do we make sure that diabetes is
one of those diseases that ARPA-H addresses?
Dr. Collins. Well, fortunately, because I think we do have
a pretty good budget being proposed here, and diabetes is
already mentioned by the President as one of the three areas of
interest, I think diabetes is extremely likely to be on the
list.
Senator Shaheen. Good. Thank you. I am glad to hear that.
COVID-19 VACCINE BOOSTER SHOTS
Dr. Fauci, the question that everybody is asking is, are we
going to need a booster shot to complement our COVID
vaccination? Do you have any sense of that and what the timing
might be for that?
Dr. Fauci. Two parts to that question, and they are
separate but important. I do not anticipate that the durability
of the vaccine protection is going to be infinite. It is just
not.
Senator Shaheen. Right.
Dr. Fauci. So, I would imagine we will need at some time a
booster. What we are figuring out right now is what that
interval is going to be. We know from studies following people
from the original clinical trials that the protection goes out
at least 6 months, and likely a year. But, we do not know right
now how long that will be.
So, what we are doing is we are following those cohorts
because there is a level of protection that is called a
correlate of immunity, and we know that if you are above that
level, you are in quite good shape to be protected.
The vaccine itself gives you a level up here. So, how long
it takes to start coming back down, we are following it, and
two ways of understanding that. One, does, from a lab
standpoint, it get below a certain level; or, do we start
seeing a lot more breakthrough infections. Either of those
would be a trigger. But, we are following that very carefully.
So, in answer to your first part of your question, I
believe we will need a booster. I am not exactly sure when.
Senator Shaheen. Thank you.
SUBSTANCE USE DISORDER AND METHAMPHETAMINE RESEARCH
And, Dr. Collins, you may remember that New Hampshire is
one of the hardest hit States by the substance use disorder
epidemic. And we have seen a decline over the last year because
of the pandemic, but we have also seen a replacement of many of
those opioids by meth. I think there is a belief among some
people who use substances that meth cannot kill you in the same
way that an opioid can. And, yet, as I talk to providers, they
tell me there are very few treatments that they have available
to them to deal with meth.
So, can you tell me what the National Institute on Drug
Abuse is doing to try and address the meth piece of substance
misuse?
Dr. Collins. Absolutely. This is an area of intense
interest and concern because what was primarily an opioid
crisis is now very much becoming a mixed crisis of opioids and
stimulants, and particularly methamphetamine.
I was pleased to see that NIDA (National Institute on Drug
Abuse) ran a trial, a phase three trial, on treatment for
methamphetamine addiction, which is a combination of injectable
Naltrexone and oral Bupropion, and showed benefit. We have not
previously had anything to offer to help people who are
addicted to meth. That is one step forward.
We also now are running this effort to vaccinate people
against methamphetamine. I know that sounds odd, but you could
immunize against that compound in a way that it would no longer
provide anybody much of a benefit if they decided to use it
anyway. We are doing that for heroin and Fentanyl, and we are
doing it for meth. But it is very helpful.
Senator Shaheen. Excuse me for interrupting. Does that work
if people have already been users?
Dr. Collins. It will. So, basically, getting your immune
system to make an antibody so that in the future, if you
encounter that drug, it cannot get to your brain because the
antibodies grab onto it.
Senator Shaheen. I will have to learn more about that.
Thank you. My time is up.
Thank you, Madam Chair.
Senator Murray. That is very interesting. Thank you.
Senator Kennedy.
Senator Kennedy. Thank you, Madam Chairman, Chairwoman.
GAIN-OF-FUNCTION RESEARCH IN CHINA
Dr. Fauci, I believe you have testified that you did not
give any money to the Wuhan lab to conduct gain-of-function
research. Is that right?
Dr. Fauci. That is correct.
Senator Kennedy. How do you know they did not lie to you?
Dr. Fauci. Excuse me, sir?
Senator Kennedy. How do you know they did not lie to you
and use the money for gain-of-function research anyway?
Dr. Fauci. Well, we have seen the results of the
experiments that were done and that were published and that the
viruses that they studied are on public databases now. So, none
of that was gain-of-function, so----
Senator Kennedy. How do you know they did not do the
research and not put it on their website?
Dr. Fauci. There is no way of guaranteeing that, but in our
experience with grantees, including Chinese grantees, which we
have had interactions with for a very long period of time, they
are very competent, trustworthy scientists. I am not talking
about anything else in China. I am talking about the
scientists. That you would expect that they would abide by the
conditions of the grant, which they have done for the years
that we have had interactions.
Senator Kennedy. So you do not think the Chinese would lie
to you?
Dr. Fauci. Well, when you say the Chinese, the Chinese are
a rather broad group. I know the scientists that we have dealt
with have been trustworthy.
Senator Kennedy. You think all the scientists have told the
truth in terms of the origin of the Wuhan virus and not been
influenced by the communist party of China, do you?
Dr. Fauci. I do not have enough insight into the communist
party in China to know the interactions----
Senator Kennedy. Right.
Dr. Fauci [continuing]. Between them and the scientists,
sir.
Senator Kennedy. Right. Why are we giving them money in the
first place?
Dr. Fauci. Well, that is a very good question, and thank
you for giving me the opportunity to----
Senator Kennedy. You are welcome.
Dr. Fauci [continuing]. Answer it. Well, SARS-CoV-1 started
in China in Guangdong Province, and it went from a bat to a
civet cat to a human.
Senator Kennedy. Yes, and excuse me, Doc, for interrupting
you, but our time is so limited.
Dr. Fauci. No, no. I am going to be real quick.
Senator Kennedy. Our time is so limited. Why are we giving
money to the labs in China to study virology?
Dr. Fauci. Well, I am going to give you a rather succinct
answer to that, sir.
Senator Kennedy. I would appreciate that.
Dr. Fauci. And that is why I was saying the SARS-CoV-1,
clearly the bats that have the viruses that are the
coronaviruses are in China. As I said a couple of times, it is
not in Fairfax County, Virginia or is it in New York. It is in
China. So, if you want to show and study importantly the
animal-human interface, the viral----
Senator Kennedy. Because that is where the bats are?
Dr. Fauci. Yes, the bats.
Senator Kennedy. Okay. I got it.
Dr. Fauci. That is where the bats are.
Senator Kennedy. I want to be sure I understand your
testimony. You did not give money to the Wuhan lab to do gain-
of-function research?
Dr. Fauci. That is correct.
Senator Kennedy. And you believe they did not do gain-of-
function research because they told you they did not?
Dr. Fauci. We have seen the results of the studies that
they conducted and they were not gain-of-function.
Senator Kennedy. Including any private studies?
Dr. Fauci. Excuse me? Including?
Senator Kennedy. Any private studies.
Dr. Fauci. I am not sure what you are getting at, sir.
Senator Kennedy. Here is what I am getting at. You gave
them money and you said, don't do gain-of-function research.
Dr. Fauci. Correct.
Senator Kennedy. And they said, we won't?
Dr. Fauci. Correct.
Senator Kennedy. And you have no way of knowing whether
they did or not except you trust them; is that right?
Dr. Fauci. Well, we generally always trust the grantee to
do what they say, and you look at the results----
Senator Kennedy. Have you ever had a grantee lie to you?
Dr. Fauci. I cannot guarantee that a grantee has not lied
to us because you never know.
Senator Kennedy. Yes. Can we agree that if you took
President Xi Jinping and turned him upside down and shook him,
the World Health Organization would fall out of his pocket?
Dr. Fauci. I do not think I can answer that question, sir.
I am sorry.
Senator Kennedy. Well, do you think President Xi Jinping
has undue influence over the World Health Organization, do you?
Dr. Fauci. I have no way of knowing the influence of the
president of China over the WHO.
Senator Kennedy. Okay. So you think the WHO is a completely
independent body and level playing field, call-it-like-you-see-
it, and they really want to get to the bottom of the origin of
the virus? Do you believe that?
Dr. Fauci. My interaction with the WHO and for Dr. Tedros,
the Director General, has been one----
Senator Kennedy. Okay.
Dr. Fauci [continuing]. That I do believe he is a person of
high degree of integrity.
INVESTIGATION INTO ORIGIN OF COVID-19
Senator Kennedy. I got it. I want to ask one last question.
Why did you guys spike--not guys, and ladies. Why did you all
spike the prior administration's investigation into the origins
of the coronavirus and whether it could have come out of the
Wuhan lab?
Dr. Fauci. Sir, I--we did not spike anything in the prior
administration. I am not sure what you mean by spike. But, we
have no influence----
Senator Kennedy. The State Department spiked the prior
administration's study.
Dr. Fauci. But that has nothing to do with the National
Institutes of Health.
Senator Kennedy. So they did not consult with you all?
Dr. Fauci. They did not.
Senator Kennedy. Did they consult with you, Dr. Collins?
Dr. Collins. I read about it in the press this morning.
Senator Kennedy. Doc.
Dr. Bianchi. No.
Senator Kennedy. They just spiked it without talking to
their experts?
You do not want to answer that one, do you?
Dr. Collins. I just read about it.
Senator Kennedy. Thank you, Madam Chair.
Senator Murray. Senator Murphy.
Senator Murphy. Thank you very much, Madam Chair.
Listen, the World Health Organization is the most
influential global public health institution in the world,
whether my friends like it or not. They have more people and
more influence on the ground across the world than anybody
else, including the United States.
And, so, if the complaint is that any country, including
China, has too much influence, the answer is not for the United
States to walk away. The answer is for the United States to
double down and make sure that any grievances we have are
addressed. Otherwise, the problem for which you are identifying
is exacerbated by the United States not being at the table with
the WHO.
And while the major donors to that organization certainly
have lots of influence, as is the case with every international
organization, it is an oversimplification to suggest that they
are in the pocket of the Chinese government. China has
influence. The United States has influence, as well, so long as
we are at the table.
FIREARMS RESEARCH
I have two areas to cover, and the first I wanted to raise
with you, Dr. Collins, and that is around the budget request to
double the firearm injury and mortality prevention research
account. Let me place myself solidly behind that request. Thank
you for making it, and I was hoping you might--I apologize if
you have gotten a question on this already. I have been
listening but in and out a bit.
I am hoping that you might be able to talk a little bit
about how you might prioritize that additional funding,
especially as it might relate to research on community-based
interventions and what works and what does not. And, then, you
know, how to make sure that all that information gets out to
community partners, folks who are boots on the ground, maybe
not the exact set of players that NIH is used to disseminating
information to.
Dr. Collins. Well, I appreciate the question, and we are
enthusiastic about expanding our approach and the amount of
funds we can put into research on firearm violence. After all,
some 40,000 deaths happen each year from firearms. About 60
percent of those are suicides, which is another topic that came
up earlier and is also part of our suicide prevention, is to
think about availability of guns.
I think you are right, though, that community approaches
are very much ripe for this kind of approach, where you might
not just try to change one thing in the community, but see if
by coordinating the efforts across multiple different ways in
terms of making sure that firearms are not accessible to those
people who might misuse them; in terms of particularly
adolescent and youth risks of violence and how to intervene.
Maybe we could take an approach that would be more holistic
as opposed to trying to fix one thing at a time. With a larger
amount of funding here and a community focus, I think we might
be able to do that.
Senator Murphy. The President has proposed, I think, $5
billion to support these community-based interventions. Maybe
some of that will be used for assessment and study. But, given
the fact that I think we probably can get bipartisan agreement
about supporting these investments in prevention, it really
would be helpful to use some of this increased funding to
assess which ones work and which ones do not.
SOCIAL DETERMINANTS OF HEALTH
Second broad topic, and maybe I will address this both to
Dr. Collins and I think, via video, Dr. Perez-Stable, is on the
topic of social determinants of health. And I am just
interested to hear a little bit about how we have adjusted
research based upon our growing understanding that people's
health is dictated by where they live and how much money they
make and how close they are to pollution sources.
My sense is that, you know, this is not an easy sort of
thing to incorporate into a research community that is sort of
used to working in labs and not always used to thinking about
how factors outside the body impact health. What have we
learned? How has that changed the way that we fund research and
encourage applications to come to NIH that might support social
determinant research?
Dr. Collins. I am going to ask Dr. Perez-Stable to respond.
Dr. Perez-Stable: Thank you, Dr. Collins, and thank you,
Senator Murphy, for that important question.
At the National Institute on Minority Health and Health
Disparities, and throughout NIH, the topics of social
determinants of health have always been present. We consider
self-identified race and ethnicity and socioeconomic status
standard measures to be fundamental factors that influence
health in ways that we do not really understand, and that is
why we believe that all research with human beings should
measure these routinely and follow them.
In addition to these two, though, there are other
demographic and individual social determinants of health, of
which many are issues related to age and gender, sexual
orientation, but then structural social determinants of health
that you refer to. Where one lives, plays, and prays, relate to
both transportation, housing, and issues around green space
and, of course, Internet access, which has become incredibly
important, as we know, in the last year. So, we have these
fundamentally incorporated into our standard research, and
community engagement is really part of everything that we do at
NIMHD, and increasingly across the Agency.
Senator Murphy. Well, thank you for that. I appreciate the
new focus you are putting on this. Again, this is an area of
potential bipartisan agreement. Senator Sullivan and I have
legislation in this space and look forward to working with you
on it.
Thank you, Madam Chair.
Senator Murray. Thank you. Senator Shelby, are you ready?
You want me to----
Senator Shelby. Yes, I am ready.
Senator Murray. Okay.
Senator Shelby. I just got here. Thank you. I have been at
another hearing, and this question may have been asked.
Dr. Collins, always good to see you.
Dr. Collins. Likewise.
Senator Shelby. I agree with a lot of people on this
committee that the money we put in to biomedical research
benefits mankind, period. Not just our people, but the world,
what it has taught.
AUTOIMMUNE RESEARCH BREAKTHROUGHS
Two or three promising areas, biomedical research in the
area of autoimmune--that is a big, big topic. You know it
better than anybody. What are we--what are the breakthroughs
there, the hopes, in two or three of those top areas?
Dr. Collins. Well, thank you, Senator. It is good to see
you, and I know you are running from one place to another. I am
glad you are here.
I just had a wonderful experience yesterday afternoon
listening to presentations from a consortium of researchers
that we have funded jointly with industry. So, this is called
the Accelerating Medicines Partnership, and it is focused on
rheumatoid arthritis and lupus.
What they have done is to take this field, which was
looking at immunology in a way that was pretty cutting edge 5
years ago, and now completely transformed it by looking at
individual immune cells in the synovium of people with
rheumatoid arthritis--the lining of the joint--and say, what
are you doing there, immune cells, and how does that teach us
what the real pathogenesis about----
And for lupus, they are looking at kidney biopsies,
because, of course, lupus affects the kidney and that is one of
its serious consequences. Same thing, looking at individual
cells.
It has completely revamped our understanding of these
diseases. We have learned, for instance, that the pericyte,
which was just sort of a cell that we thought was hanging out
watching in the kidney of somebody with lupus, might be the
driver of what is really happening there as far as the immune
response. This is not p-a-r-a. This is p-e-r-i, cyte, in case
that is not clear. For rheumatoid arthritis, it is the
fibroblasts.
And we are so excited about this. We are now planning to
expand that same approach to other autoimmune diseases, to
psoriasis, to psoriatic arthritis, to Sjogren's Syndrome, and
maybe others, as well.
So, you hit me at a great moment. I was so jazzed yesterday
to see what has been possible.
Senator Shelby. All based on bacteria, is it?
Dr. Collins. It is all based on this ability to look at
single cells, one at a time. We have not really been able to do
that until about 5 years ago. We would have to look at
thousands of cells and try to infer what was there, and now you
can ask each one. And the cell is, after all, the basic unit of
all life, and it has been outside of our reach, but not
anymore.
Senator Shelby. What could that do for the autoimmune area?
Dr. Collins. I think it can have a huge impact because we
now have new targets coming out of this recognition that I
think in the next 4 or 5 years, we are going to see a whole new
generation of drugs for autoimmune diseases based upon that
insight that is just now emerging.
CYSTIC FIBROSIS RESEARCH
Senator Shelby. I brought this up many a time, but in the
area of cystic fibrosis, there have been so many breakthroughs
in that area, extending children's lives, adults' lives, and
everything. Where are we going there? We have come a long way,
but we are not there yet.
Dr. Collins. We are not completely there, but, oh, boy,
have we come a long way, especially in the last 2 years now
with this 30-year effort, and I have been deeply engaged in
this having had a role in----
Senator Shelby. I know.
Dr. Collins [continuing]. Discovering the gene back in
1989. And, now, we have this triple drug therapy, which for 90
percent of patients with cystic fibrosis is dramatically
beneficial. I get messages almost every week from somebody who
was really in tough shape, and now they are back at work; or
somebody who was on a transplant list, and now they were taken
off of it because their lungs are doing so much better.
But, there is still that 10 percent. This is where I think
the gene-editing approach, where you actually figure out how to
fix that misspelling of the cystic fibrosis gene in the lungs
of somebody who is affected, might be the way to get to 100
percent, and there is a lot of work going on that.
LUPUS RESEARCH
Senator Shelby. What promises are out there that you have
talked about before dealing in lupus, which is an autoimmune
disease?
Dr. Collins. Well, as I mentioned, we have this ability now
to be able to see individual immune cells, what are they up to
in lupus, both in the kidney and in other areas, as well. I
think that is teaching us some new things about what the real
fundamental cause is. And it will tell us that some of the
treatments we have been giving, like steroids, are kind of a
little bit too much of a sledgehammer, and what we need now is
something much more subtle to go after the fundamental problem.
We have a better chance at that now.
PANCREATIC CANCER RESEARCH
Senator Shelby. What about the area of pancreatic cancer?
That is a fast-moving thing, I know.
Dr. Collins. It is, indeed. And if Dr. Sharpless is
listening, maybe he would like to quickly give a response since
that is his area at the Cancer Institute. Ned, are you there?
Dr. Sharpless. Sure. Yes. Thank you, Francis.
Pancreatic cancer is an area where we have not seen the
success that we have seen in other cancers, but it is not for
lack of good ideas. So, there are a number of----
One of the realizations is that pancreatic cancer comes in
lots of flavors, and each one needs its own treatment. So, now
we are working on the subset approach to pancreatic cancer. I
think there is also a real opportunity to detect pancreatic
cancer earlier at a more curable stage.
So, I think those are the exciting areas of pancreatic
cancer research.
Senator Shelby. Thank you. I would like to get in--I know
my time is moving on. The chairperson has been very kind.
CTSA PROGRAM
Dr. Collins, in the area of the CTSA Program, the Clinical
and Translational Science Award Program. The CTSA hubs and
their partners, I think, have done a lot of good work in that
area, and valuable work, especially during the COVID-19 thing.
It is my understanding that the NIH, National Institutes of
Health that you head, is considering significant changes to
that program that would discourage hubs, like UAB, for example,
in Birmingham, from forming partnerships with certain non-
clinical universities in research questions.
Is this true, and why is that?
Dr. Collins. That is not a correct assumption. I know there
are some rumors flying around about that, and there will be a
public announcement about this.
Basically, just, without trying to get too far ahead of
what has not been revealed publicly, I think we are trying to
simplify the application process to make it easier for those
hubs, and we intend to keep them going in vigorous ways; to
apply when they are up for renewal in a way that does not
require an application of 2,000 pages, which is what it has
been. But, we would not want to do anything to discourage these
collaborations that you are mentioning. Take that from me.
Senator Shelby. Thank you. Madam Chair, thank you.
Senator Murray. Thank you. Senator Manchin.
Senator Manchin. Thank you, Madam Chairman, and thank all
of our presenters. I appreciate very much them being here.
DOMESTIC DRUG SUPPLY CHAIN
My first question will go to Dr. Fauci. The Food and Drug
Administration reports that nearly 40 percent of finished drugs
and roughly 80 percent of active pharmaceutical ingredients are
manufactured abroad. During the COVID-19 pandemic, we saw
factories shut down in order to prevent the spread of virus,
drug supply chains disrupted, and drug shortages increase. As a
result, America's access to essential medicines was really put
into jeopardy.
As a preeminent infectious disease doctor, you know better
than anyone how important it is to have access to essential
medicines. So, my question will be, Doctor, can you comment on
the importance of a strong domestic supply chain for essential
medicines? And how can we ensure we do not experience future
drug shortages when the global supply chains are disrupted?
Dr. Fauci. Thank you very much for the question, Senator
Manchin. I think it is absolutely critical that we have the
capability, independent of supplies from foreign countries, to
be able to supply the necessary medicines that we need in the
United States. I have been of that opinion for a very long
period of time.
The solution to the problem is to be doing much less of the
outsourcing to foreign countries for the important ingredients
of many of our medications. So, right now, we are not in that
good position, and I believe, particularly since the
disruptions of the supply chain that have occurred with the
COVID-19 pandemic, that this might be a good lesson for us for
the future to make sure we have much more dependency on what we
can do domestically as opposed to in foreign nations.
Senator Manchin. Doctor, have you all looked at why? Why
has most of the manufacturing left the United States and why
are we not able to manufacture? Are we at a disadvantage in the
United States for other reasons, cost wise, or basically
different types of things, that we make people jump through
hoops and everything else as far as permitting and all that?
What would be the cause?
Dr. Fauci. You know, Senator, to be honest with you, I do
not know why that has happened. I think it was because it was
felt it would be much less expensive to get this done outside,
but I do not really know the answer to your question of why we
have so much of a dependency of important materials outside of
the Country. But, certainly, whatever the reason, I believe it
needs to be corrected.
Senator Manchin. Well, I need to work with you on that,
Doctor, if I can, basically, in making sure this
Administration--I think they understand the urgency we need to
start basically manufacturing again, not only just our drugs,
but so many things in our Country. So, I look forward to your
support on that.
RURAL HEALTH OUTCOMES
Dr. Collins, West Virginia is constantly ranked last in the
Nation for health outcomes. In 2020, the America's Health
Rankings reported my State of West Virginia 50th for premature
deaths, frequent mental distress, and multiple chronic
conditions. We also ranked last in life expectancy.
What is the NIH doing to bridge this gap in health
outcomes? And how do you ensure that the medical research that
you do benefits people in poor, rural communities?
Dr. Collins. Well, it is very troubling to see the fact
that you have just cited that health outcomes are not what we
would all want them to be. And, of course, there are many
factors that play into that, Senator, and we are deeply engaged
in research in trying to identify the ones that are
addressable.
Certainly, one of the things I might point to is the
increasing focus we have on disease prevention. If we simply
are limiting ourselves to trying to help people who have
already developed a serious disease, we have kind of missed the
opportunity. Unfortunately, our healthcare system does not do a
great job in that situation of providing support for disease
prevention, and it seems happier to pay for things once people
are already quite ill, so there is additional work that needs
to be done there.
One of the things that I think I would point to is a series
of large-scale efforts to really understand what are the
factors that play out in people staying healthy or getting a
chronic disease or how you manage that.
The All of Us Program, which this Congress has supported,
on the way to enrolling a million participants, including in
West Virginia, is a way in which we can collect that kind of
evidence, including their electronic health records and lots of
information about their environmental exposures, and try to
figure out in a holistic way, how can we take that information
and bring forward a better chance for people to live not just a
good lifespan, but a good health span. So, we are----
Senator Manchin. Thank you, Doctor.
Dr. Collins [continuing]. Deeply engaged.
Senator Manchin. Thank you, sir.
Dr. Fauci, finally, you know, my home State of West
Virginia is battling an epidemic during the middle of a
pandemic. We have been devastated by the drug epidemic, COVID-
19, and now--we now lead the Nation in new HIV infection rates.
You spent much of your career focused on prevention, diagnosis,
and treatment of HIV/AIDS, and your research has been
instrumental in saving countless lives in the United States and
around the world.
INFECTIOUS DISEASE SURVEILLANCE EFFORTS
So, Doctor, what is being done to replicate testing and
surveillance efforts we saw put into place for COVID-19 for
other infectious disease, like HIV/AIDS? And what public health
infrastructure would be required to bring better infectious
disease testing and surveillance to fruition?
Dr. Fauci. Thank you for that question, Senator. The HIV
testing situation, unfortunately, has been somewhat interrupted
by the COVID-19 pandemic because of the interruption of
multiple services.
But, as you know, we have a 10-year plan to end HIV as an
epidemic in the United States, and that is going to require
access to testing for those who are not infected to put them
on, if they are at risk, to pre-exposure prophylaxis; and those
who are infected to immediately put them on antiretroviral
therapy. Because, as we know, when you bring the level of virus
to below detectable, not only do you save the life of the
individual, but you make it essentially impossible for that
individual to infect someone else.
So, testing is really at the fundamental basis of how you
address the epidemic and, for that reason, it is going to be
extremely important to get our testing capabilities back up to
snuff once we get the Country back on a degree of normality
following control of the COVID-19 pandemic.
Senator Manchin. Thank you. Thank you, Madam Chairman.
Senator Murray. Thank you. Senator Braun.
Senator Braun. Thank you, Madam Chair.
Dr. Fauci, I was listening with interest in Senator
Kennedy's line of questioning, which probably was asking you to
maybe answer some things based upon what the WHO should do or
not.
INVESTIGATION INTO ORIGIN OF COVID-19
I would like to discuss something that is probably a little
simpler to answer in terms of transparency in general. From the
time I have known you and Dr. Collins, it has generally been in
this seat, and we have been talking about something related to
COVID. Would you agree that in the whole process of--now that
there are second thoughts on how this thing derived, that it
may have come from a lab, that we should emphasize as much
transparency as possible in pursuit of getting the answer?
Dr. Fauci. Without a doubt, Senator. No doubt.
Senator Braun. And the next logical question would be that
we do not know what we are going to get from the communist
regime or the WHO, but we do know that through our Director of
National Intelligence and probably DHS (Department of Homeland
Security), from Haines and Mayorkas, that they have probably
got information there. And, so, since you believe in
transparency, wouldn't you think that we should declassify all
the information that we own so that you, Americans, independent
researchers, can see what we have got to sort through how this
thing started?
Dr. Fauci. Well, Senator, I have said publicly and most
recently that I believe that there should be transparency, and
open, fair, and independent, continue to look. As I have said,
I still believe that the most likely scenario is that this was
a natural occurrence, but no one knows that 100 percent for
sure. And since there is a lot of concern, a lot of
speculation, and since no one absolutely knows that, I believe
we do need the kind of investigation where there is open
transparency and all the information that is available to be
made available to scrutinize.
Senator Braun. So, since you have been the point person on
just a variety of topics through the COVID saga, does that mean
then that you will ask President Biden to declassify that
information?
Dr. Fauci. I do not think I can promise you----
Senator Braun. But, I mean, would you ask him since you
believe in transparency? Wouldn't it make sense that we get the
information that we have? And I think if it does not come from
you, Dr. Collins, someone that has been in the mix from the
get-go, that we will not see it. And we owe it to the American
people with what we have been through to at least look at the
information that we have.
Dr. Fauci. Yes. I am not sure the information we have,
but--I am not sure if it is my place to tell the President of
the United States to declassify----
Senator Braun. But you have been very engaging on a wide
range----
Dr. Fauci. Right.
Senator Braun [continuing]. Of topics, and I think he would
respect your opinion as much as anyone.
Dr. Collins, where are you at on that subject of giving the
American people the information that we house?
Dr. Collins. Well, I am very much where Dr. Fauci is with
the desire to be as transparent as possible in this situation
and really try to find out what happened. I agree with him that
it is most likely that this is a virus that arose naturally,
but we cannot exclude the possibility of some kind of a lab
accident. That is why we have advocated very strongly that WHO
needs to go back and try again after the first phase of their
investigation really satisfied nobody, and this time we need a
really expert-driven, no-holds-barred collection of
information, which is how we are mostly really going to find
out what happened.
I am just not in a position to know what might be in the
classified documents and what else might be there that would
not be relevant to this and might actually be harmful to
national security. I get--I take your point. But, I know the
President is very interested, also, in seeing truth come out
here, so it may not require Tony or me to tell him that this
would be good, to make this as visible as possible.
Senator Braun. Well, I think for the American public, if we
are relying on the WHO to do it again, even though it seems
like they have had somewhat of an epiphany that we need to dig
deeper. I think if it does not come from the two of you to ask
for simply the release of information, of course, keeping
hidden anything that would be something that could not be
exposed. But, I am guessing there is a good bulk of that that
would be benign in terms of just the information we have about
the origin of the disease.
So, I think for many of us, many Americans, with what we
have gone through, we ought to at least be willing to look at
the information that we have to get people satisfied that we
are getting to the bottom of it. So, I would ask each one of
you to think about that and see if it makes sense, have our
President declassify it so we can see it.
Dr. Collins. Thank you.
Senator Braun. Thank you.
Senator Murray. Thank you. Senator Moran.
Senator Moran. Chairman, thank you.
Dr. Collins--well, Doctors, welcome. Good to be here with
you, and I appreciate your presence and your work.
Let me talk about clinical and translational science, if I
could. Under Dr. Austin's prior leadership, the National Center
for Advancing Translational Science at NIH has been essential
in facilitating clinical and translational research, and I have
seen it in Kansas. In fact, I have seen it with the director of
that directorate.
CTSA PROGRAM
In Kansas, NCATS' Clinical and Translational Science Award
Program has served for a catalyst to bring lots of
organizations in the research community and community partners
together to advance research.
I have concerns with potential changes that are under
consideration for the CTSA Program. In particular, changes that
would lower hub awards and limit CTSA partners.
Moving forward, will there continue to be consideration for
ensuring that CTSA centers are located in regions in the U.S.
which do not already have those hubs? There is already a
limited number in the Mid-West, and I would be concerned if any
new changes to the program that would make it more difficult
for these hubs to compete.
And, then, I would ask the question about partners. At the
University of Kansas, for example, they partner with Children's
Mercy, Kansas City University of Medicine and Biosciences,
Kansas State University, St. Luke's Health, University of
Kansas Health System, KU Office of Research, KU School of
Medicine in Wichita, and University of Missouri in Kansas City.
Since the CTSA Program is focused on partnerships between
regional research hubs and community partners, why would NCATS
limit the ability of the program, in my view, to accomplish its
goal?
Dr. Collins. Well, Senator, thank you for the question. I
am a big fan of the CTSA Program and enjoyed my opportunity to
travel to Kansas with you and see some of the things they were
doing a few years ago.
And this is, I think, one of those circumstances where
there seems to be some anxiety in the CTSA community about
something that has not actually been announced yet, and I would
like to be reassuring about this. The real intention of the
change that is being proposed is to de-complicate the renewal
process, which currently requires an application of about 2,000
pages that I do not think anybody enjoys putting together, and
to try to make this more straightforward.
There is no intention to reduce the number of hubs.
Certainly, every hub has to compete to show that they are
actually using the funds wisely, and we will continue that
process. And this notion that somehow the new process will
discourage collaborations with other institutions I find a
little hard to understand because I have no knowledge that that
is at all intended to be the case, and I would personally
oppose that.
Senator Moran. Thank you for your reassurance. My question
was more complicated than I wanted it to be, but your answer
was very comforting.
Let me ask just a couple of specific questions.
NCATS RARE DISEASE RESEARCH
What can this committee do to support NCATS' efforts to
enable and facilitate advanced important research in rare
diseases for patients living particularly in rural communities?
Dr. Collins. Well, the NCATS is deeply engaged in rare
diseases. Our former director, Chris Austin, not only was a
personal promoter of that; he was the head of the international
committee for rare diseases, and that tradition will continue
under Acting Director, Dr. Rutter.
Certainly, the support that this committee has provided to
NCATS to make it possible for that kind of investment to happen
in rare diseases, for which companies probably are not going to
make an investment because the market is too small, is one of
the reasons that we have now made really significant progress
in dozens of these rare diseases.
We are also engaged right now in a serious conversation
with industry about whether there is a way, with gene therapy
emerging as an even more attractive opportunity for rare
diseases, to make sure that we move that forward at all due
speed and not have it held up by such things as a limitation in
manufacturing of viral vectors.
So, they are right in the middle of that, and the support
that you all have provided has made that possible, particularly
through the Cures Acceleration Network, which is part of NCATS.
ALZHEIMER'S DISEASE RESEARCH
Senator Moran. Can one of the directors talk about the
improved science this additional investment in Alzheimer's
research will help fund, including a better understanding of
risks and protective factors in individuals, again perhaps with
a focus on rural populations?
Dr. Collins. That is probably me because Dr. Hodes is not
here. So, yes, this committee, this Congress, has increased
funding for Alzheimer's research by five-fold over the course
of the last 7 or 8 years, and that has made possible all kinds
of bold approaches we otherwise would not have had.
We now have dozens of new drug targets that have emerged
from the very careful analysis of who gets Alzheimer's and who
does not. Of course, we are all waiting to see what happens
maybe next month when FDA makes a review decision about the
monoclonal antibody from Biogen, Aducanumab, and that will make
a big difference if they decide there is something there. But,
we are not depending on that.
So, yes, I might add, this ARPA-H proposal, which is part
of the President's budget, specifically calls out Alzheimer's
as an area of great opportunity to do some of these very bold,
aggressive, and nimble approaches that would probably not
happen so easily by our standard grant mechanism.
Senator Moran. Dr. Collins, I was confused by what I
thought was all the directors were appearing, although just not
all of them in person. But, thank you. You can pinch-hit for
each and every one of them and you did it----
Dr. Collins. I will try.
Senator Moran [continuing]. This morning. I am going to see
if I can get Dr. Sharpless to come to Kansas and join us again
on a visit.
Dr. Collins. Well, he is listening, so he heard you.
Dr. Sharpless. Oh, I look forward to that.
Senator Moran. All right. Consider yourself invited, and I
consider you just accepted.
[Laughter]:
Senator Murray. Thank you. Senator Schatz.
Senator Schatz. Thank you, Chair Murray and Ranking Member.
PSYCHEDELIC DRUG THERAPIES
Dr. Collins, in 2019, I wrote to you and the then-FDA
commissioner requesting an update on efforts by NIH and FDA to
research psychedelic drugs to treat mental health illnesses.
Since then, there have been a number of potentially promising,
peer-reviewed clinical research on this topic. Can you give me
an update on what the next steps may be?
Dr. Collins. I appreciate the question. Yes, there has been
a resurgence, I think, of interest in psychedelic drugs, which
for a while were sort of considered like not an area that
researchers legitimately ought to go after. And I think as we
have learned more about how the brain works, we have begun to
realize that these are potential tools for research purposes
and might be clinically beneficial.
I will just mention one, which is Psilocybin, which has now
been tried in no less than three randomized, controlled trials
for depression, and is showing a signal there of potential
interest, and that could be quite exciting because we are
looking for new approaches to that.
But, there are other trials going on with MDMA, even with
Psilocybin--with LSD. I think at the moment, it is the
Psilocybin that has gotten the greatest attention.
Senator Schatz. And what are your next steps?
Dr. Collins. I have been talking with the Drug Abuse
Institute--and I am sorry they are not here--and the Mental
Health Institute--and they are not here, so I am pinch-hitting
for them, as well--about whether it is a good moment to
consider having perhaps a workshop to say, okay, what have we
learned so far, and what more might we want to do as far as
designing the next generation of clinical trials, to see where
these provide benefit going beyond depression to such things as
PTSD (Post-Traumatic Stress Disorder).
So, I think over the course of the next year, we are going
to want to have a hard look at this.
MARIJUANA RESEARCH
Senator Schatz. Thank you. In 2019, you wrote to me that
the NIH is committed to advancing research on the risks and
potential benefits of marijuana for therapeutic uses. In that
letter, you cited a number of barriers to advancing this type
of research. Are we making any progress?
Dr. Collins. We are making some progress. You may know
that, in the past, researchers who wanted to do a clinical
study on marijuana had all kinds of limitations. It took
generally at least a year to get through the process of
paperwork to be allowed to utilize marijuana because it is a
Schedule 1 agent.
But, it was also an issue that there was only one source,
which was our marijuana farm in Mississippi. When I became NIH
director, I was told, hey, you are running a marijuana farm.
Who knew? And that, of course, is an issue because it is a
limited opportunity for access. DEA (Drug Enforcement
Administration) has now given permission to expand the number
of suppliers. That will help.
But, frankly, what we really need is to moderate the
Schedule 1 limitation. Dr. Volkow and I have been proposing for
a while something called Schedule 1-R, which would be basically
a different pathway if you are going to use this material for
research.
Senator Schatz. So, I have a bill with Senators Feinstein
and Grassley, which passed the Senate, did not pass the House,
to address some of these barriers. Do I have your commitment to
work with my office on this legislation?
Dr. Collins. I would be glad to.
NON-OPIOID ALTERNATIVES TO CHRONIC PAIN
Senator Schatz. Thank you. I want to talk to you finally
about chronic pain and non-opioid alternatives. I passed a
couple of laws in this area to enable research. And I think
when people think about alternatives to opioids, they move
right to--in their mind, they move right into alternative
medicine. And, what I am talking about is a non-opioid,
pharmaceutical solution to chronic pain, and I am wondering
whether we are making progress in that space.
Because, certainly, if people find other ways to alleviate
their pain--physical therapy, yoga, whatever, mindfulness--I am
for all of it. But, there is still a space here for a pill that
you can take to alleviate chronic pain without getting you
hooked on an opioid. Where are we with this?
Dr. Collins. That is a critical issue, and this Congress
has supported NIH in something we call the HEAL Initiative,
which is--stands for Helping End Addiction Long Term. Part of
that is about how to better treat people who are addicted to
opioids, but a big part of it is coming up with alternatives
for chronic pain management that are not addictive, that are
not opioids.
As a result of that, we have partnered up with industry to
basically identify promising therapeutics that attack different
targets in the pain mechanism that might, therefore, be
beneficial. Such things as a sodium channel, for instance,
called Nav1.7, that is involved in the pain transmission. But,
if you block that, it should not give you any risk of
addiction. We are making real progress there.
We have something called EPPIC-Net, which is bringing
onboard promising compounds, getting them into Phase 2 trials
as part of the HEAL Initiative. I could give you a lot more
information about that if you would like.
Senator Schatz. Thank you. And I will just submit this one
that you can consider for the record.
The U.S. has the same Federal trust responsibility for
native Hawaiians as it applies to Alaska natives and American
Indians, and I am hoping that you will consider expanding the
scope of the Tribal Health Research Office to include native
Hawaiians. I will get you a more full question for the record
and look forward to your response. Thank you.
Dr. Collins. Glad to look at that.
Senator Murray. Thank you. Senator Hyde-Smith.
Senator Hyde-Smith. Thank you, Madam Chairman. Thank you
for holding the hearing, and thanks to all the witnesses who
are participating today, and I certainly appreciate your
willingness to serve. That is not lost here, for sure, with the
past year that we have had.
FIREARMS RESEARCH AND FIREARM REGISTRIES
Dr. Collins, I wrote to you last November to express my
concerns that projects recently funded by NIH disregard the
spirit, long-established policies against creation of a Federal
firearms registry. And particularly, an NIH grant to Northwell
Health of New York provided Federal funds for the hospital to
ask the questions about lawful gun ownership of every patient
seeking healthcare for any reason whatsoever at the hospital's
emergency department.
Even more concerning, every member of the advisory
committee overseeing the grant has been a very outspoken
advocate for expansive gun control, including bans on large
classes of common and popular firearms.
I have long been concerned about how firearm registries can
undermine the ability of law-abiding citizens to exercise their
Second Amendment rights. Several provisions of Federal law
already prohibit data collection related to lawful gun
ownership, and I have introduced legislation to strengthen
these provisions even further.
Dr. Collins, given that President Biden is seeking
increased funding for grants like the one awarded to Northwell,
how are you making sure that such projects do not infringe on
Americans' constitutional gun rights or violate Federal
statutory prohibitions on gun registries as they stand right
now?
Dr. Collins. Senator, I recall your letter, and we looked
closely at that particular grant from Northwell and what they
were proposing to do.
First of all, I think we can all agree that gun violence,
which takes about 40,000 lives every year, is something that
does deserve close attention and scrutiny as far as the
research that we might be able to do to understand what are the
causes and how to save those lives if it is possible to do so.
So, we will actually be glad to pursue those opportunities.
But, we are mindful of the prohibition that Congress has
put forward many years ago about not advocating for gun
control, and we have been pretty careful about that. I think in
that instance, the particular grant, while you are right that
they were asking for this information, it fell somewhat short
of what most people would have called a broad concept of a gun
registry. And I think that is, if I remember, what we said in
the letter in response to you.
But, I want to promise you, we are going to be very
sensitive to those issues, as we now, with the President's
budget, seek to see if we can do more to try to identify
reasons that gun violence is so prominent and what research
might teach us about how to save lives.
Senator Hyde-Smith. Thank you. I appreciate your
consciousness of that.
ORIGIN OF COVID-19
And this question may have been asked before. I have been
in another hearing. I hope I am not being redundant. But, like
many of my colleagues, I firmly believe we need to get to the
bottom of the origin of COVID-19, and this seems even more
important after this week's Wall Street Journal report that
three researchers from China's Wuhan Institute of Virology
sought hospital care in November 2019--for symptoms consistent
with COVID-19.
First, I want to go down the line for all of our witnesses
of how strongly do you believe that it is possible that the
origin of the COVID-19 pandemic resulted from a leak of the
virus from the Chinese lab?
And second, Dr. Fauci, I would like to ask you
specifically, how is your institute working to get to the
bottom of the origins of COVID-19, including exploring the
laboratory leak theory?
So, I am going to start with the entire panel for the first
question of, how strongly do you believe that this is possible?
Dr. Collins. Well, I will start, and then others can
respond. Again, I will say, I think the most likely reason,
mechanism, by which SARS-CoV-2 arose was a natural process of
transfer from an animal to humans, but it is certainly possible
that other options might have occurred, including a possible
lab leak. We just do not have evidence to be able to say what
that likelihood is.
Dr. Bianchi.
Dr. Bianchi. Yes. So, I would agree with Dr. Collins. We
have no personal knowledge of anything that might have happened
in China at the National Institute of Child Health and Human
Development, but we fully support a full investigation of
getting at the facts.
Dr. Collins. Dr. Gibbons. Dr. Gibbons, are you there?
Dr. Gibbons. Yes. I concur with my colleagues in terms of
transparency is a critical part of this.
Dr. Collins. Dr. Sharpless, I think I saw you on the
screen.
Dr. Sharpless. Sure. Yes, Senator Hyde-Smith, I saw the
same report and I found that concerning. I think lab accidents
happen and we need to investigate the possibility. Although I
think many of us feel zoonotic transfer is perhaps more likely,
I think we should investigate all possible explanations.
Dr. Collins. Dr. Perez-Stable.
Dr. Perez-Stable. I concur with my colleagues. I think of
concern, but certainly we need evidence.
Dr. Collins. And Dr. Tromberg.
Dr. Tromberg. Yes, I agree with my colleagues, as well, and
would like to see more investigation.
Dr. Collins. Dr. Fauci.
Dr. Fauci. Yes. As I have said many times, I feel the
likelihood is still high that this is a natural occurrence.
But, since we cannot know 100 percent whether it is or is not,
other possibilities exist and, for that reason, I and my
colleagues have been saying that we are very much in favor of a
further investigation to the next phase from the WHO, who has
already done a phase one. And, we are strongly in support of
continuing that to a phase two investigation.
Senator Hyde-Smith. Thank you----
Senator Murray. Thank you.
Senator Hyde-Smith [continuing]. Very much, and I yield my
time.
Senator Murray. Thank you so much. Senator Baldwin.
Senator Baldwin. Thank you, Madam Chair.
Last week, I had the privilege of joining some of my
colleagues on a visit to the National Institutes of Health.
While much of our discussion was centered on the response to
the COVID-19 pandemic, I was struck by the broad applications
of the innovation that we have seen during this time.
ADVANCES IN VACCINE AND THERAPEUTIC DELIVERY SYSTEMS
(RADX PROGRAM)
And, I have often spoken about the Wisconsin-based company,
FluGen, which is working to make vaccines that can be
administered as a nasal spray. I also believe that this type of
innovation is key in terms of how we think about our ability to
respond to future pandemics.
Dr. Tromberg, it was great to see you on that trip to NIH.
I wonder if you could describe how engineering advancements
have contributed to our response to COVID-19. And, how are you
thinking about the future of delivery and administration of
vaccines and therapeutics? And, how will these advancements
help us prepare for the future?
Dr. Tromberg. Thank you, Senator Baldwin, for the question,
and it was great to meet you last week, or I guess it was 2
weeks ago when you came to visit.
So, for COVID, we have supported a wide range of
technologic advances in medical imaging and artificial
intelligence, digital health platforms, PPE (Personal
Protective Equipment), ventilators, new therapeutic approaches.
Of course, the biggest probably and most impactful has been the
RADx testing program, which has delivered, as you have seen,
more than 300 million tests, including over-the-counter tests
with very advanced technologies from nanoscience.
In terms of vaccines, this is a very exciting area. Another
one that we have had in our portfolio, one of the strategies
that we have been supporting, are micro needle patches. So,
imagine a dime-sized micro needle patch that has got--the
needles are entirely soluble in water, and as soon as you put
them into your skin, they start to deliver the vaccine. After
the delivery, the needles are all gone, and you throw the patch
away. You get a new one in the mail. So, this has moved into
Phase 1 clinical trials. Efficacy has been shown.
I might, if you have a moment, toss it over to Dr. Fauci
because we have collaborated with his institute in the
development of these new delivery approaches and they may have
some other approaches, as well.
Senator Baldwin. Please. Dr. Fauci.
Dr. Fauci. Thank you, Bruce. Yes. We have an active
collaboration with Dr. Tromberg's Institute and we are looking
towards the future about how we can make it much easier to get
people vaccinated. This is of particular relevance right now
because, with COVID-19, even though we are doing really very
well with vaccination, we still have a group of individuals who
were really difficult to get to. And hopefully, when we have a
much easier way to administer the way Dr. Tromberg has
mentioned, that will make it easier for us.
Senator Baldwin. Excellent. In April, the University of
Wisconsin launched the Center for Health Disparities Research
Center, which has a leadership team comprised entirely of
women, will focus on how physical environment and social
conditions intersect to influence an individual's health.
Their first initiative, funded by the NIH, will use data
from 22 Alzheimer's disease research centers throughout the
U.S. to examine how social determinants of health throughout a
person's lifetime impact their brain health.
The pandemic has made it clear that we need to do more
research like this to better understand and respond to health
inequities, and I applaud the work of Dr. Amy Kind and the
University of Wisconsin. It is imperative that we maintain our
commitment to this into the future.
COVID-19 AND HEALTH DISPARITIES
So, Dr. Perez-Stable, how has the impact of the COVID-19
pandemic on communities of color informed how NIH thinks about
studying health disparities going forward? And what additional
investments are needed to fill these gaps?
Dr. Perez-Stable. Thank you, Senator Baldwin, for that
question. I think a year ago, when we understood the dimension
of the dramatic, disproportionate burden by race, ethnicity,
and socioeconomic status on the population, there was sort of
an aha moment for all of NIH to say, this problem has been with
us for a long time. We have made limited progress. It is time
we put our innovation, our efforts, to address this.
Out of this effort, we created the Community Engagement
Alliance Against COVID-19. Dr. Gibbons and I are co-chairing
that. Dr. Collins mentioned it in his opening statement. And I
think to heighten the importance of community engagement, so
talk to the people that are affected, bring them in as full
partners, identify the problems, and then mobilize all sectors
that we can mobilize. Not just the researchers and the
healthcare clinicians, but also the housing, transportation,
zoning, all the different sectors of society, to see how we can
begin to make a difference in this setting.
And I applaud the effort of Dr. Kind. She was a grantee of
ours, as well as others, and also applaud the effort of looking
at existing data with standardized measures to address problems
of this kind, like Alzheimer's disease.
Senator Baldwin. Yes. Thank you so much.
Madam Chair, I yield back.
Senator Murray. Thank you. Senator Rubio.
Senator Rubio. Thanks, all of you, for being here.
I think I will direct this to Dr. Fauci, but I welcome
everybody's answer. I just want to go through, so, what we do
know. We have heard a lot about what we do not know.
So, here are the things that we do know, okay?
ORIGIN OF COVID-19
So, SARS-1, we identified the host animal within 4 months.
MERS, I believe, we identified the host animal within 9
months.
It has now been 15 and a half, 16 months, we have still not
seen and China has not produced any evidence of the host animal
that transmitted COVID-19 to a human.
We know that China has a history of lab accidents. I think,
Dr. Fauci, you answered Senator Graham's question. I think he
phrased it as, has there ever been a pandemic that came out of
a laboratory, and the answer was no.
But, we know of outbreaks that came out of a laboratory. I
believe back in 2004, two researchers in Beijing were infected
doing research on SARS and it led to an outbreak. China has a
history of lab accidents.
This outbreak happened in a city that happened to be the
home, coincidentally, of a lab which we know is involved in
extensive research. And, what they do is they take this
naturally-occurring virus and they manipulate it and they
change it to make it infectious to humans. We know that they do
that there. They have published about it.
And, it also happened in a city in a lab where a Rutgers
biosecurity expert raised concerns about its safety, and our
diplomats in 2018 were cabling back to Washington expressing
concern about the safety.
So, I take all those facts together, right?
SARS, we knew the host in 4 months.
MERS we knew the host in 9.
We still do not know the host in--for COVID, even though--
and China is not being transparent about it even though they
have a vested interest in producing the host so they can put
all this down.
In a lab that we know is involved in changing viruses
synthetically so that they become infectious for humans.
In a lab that diplomats have told us is unsafe.
In a country that had history of lab leaks.
And, by the way, in a virus that we know can be
synthetically-created because the Swiss did it. The Swiss
created an exact replica of this virus in the lab for purposes
of answering it.
All of these facts were available to us last May, last
April. Why--I will start with Dr. Fauci. Why did you dismiss
the lab leak theory as credible?
Dr. Fauci. I have always said that the high likelihood is
that this is a natural occurrence. I did not dismiss anything.
I just said it is a high likelihood that this is a natural
occurrence from the environment of an animal reservoir that we
have not yet identified, and I still maintain that.
But, as I just mentioned in response to other questions,
that since you do not know 100 percent about that, because no
one knows, including me, 100 percent what the origin is, is the
reason why we are in favor of further investigation.
Senator Rubio. Well, given everything I have just cited--
and if anything I just cited is incorrect, I hope I will be
corrected. I am relying--obviously, not my field of study, so I
am relying on what other experts have published. What is the
basis for this high likely--what is the basis for the
conclusion that it is likelier to have been naturally occurring
than a lab accident?
I asked a specific question to the Director of National
Intelligence, and how I posed it is, is it not true that it is
the assessment that they are equally likely, based on our
information that we have.
So, as I outline all of these things here, is she wrong
when she answered me yes? And, based on everything I have just
cited, why the--what is it that we are basing the higher
likelihood of naturally occurring? Is it simply because that is
all we have ever seen in the past?
Dr. Fauci. Well, we have historical experience that
happened with SARS-CoV-1. It happened with MERS. It happened
with HIV. It happened with virtually all the influenza
pandemics. So, the historical basis for pandemics evolving
naturally from an animal reservoir is extremely strong, and it
is for that reason that we felt that something similar like
this has a much higher likelihood.
But, again, getting back to what I said--and let me repeat
so there is no lack of clarity in that. No one knows, not even
I, 100 percent at this point, which is the reason why we are in
favor of further investigation.
Senator Rubio. But, going back to precedent, precedents
require them to be similar. The difference between this one and
that one is--as I said, 4 months we knew the host for SARS, at
9 months we knew the host for MERS. China has all the incentive
in the world to produce this host and has not done so. And,
then, you add up all these other things, I mean, is it just a
coincidence it happened in the city that is doing this kind of
research, which, by the way, is controversial? I know you and
others have been supportive of it, but it is controversial. It
is not widely accepted as good.
My whole point is there are people out there who had
Facebook posts taken down. They are called kooks, conspiracy
theorists, for saying publically a year ago what we now say may
be possible. I think those people deserve an apology, at a
minimum.
Thank you.
Senator Murray. Thank you.
COVID-19 AND MIS-C
Dr. Bianchi, thank you. NICHD (National Institute of Child
Health and Human Development) is trying to develop ways to
identify children at high risk for multi-system inflammatory
syndrome in children. It is a rare and life-threatening after
effect of COVID-19. Now, while most children who become
infected, I know, have mild or no symptoms, some do go on to
develop this severe and sometimes fatal condition. I know your
research is still in the early stages, but could you describe
the NICHD's efforts to develop clinical, predictive models
using machine learning to identify children at risk and how
physicians are using this testing device and data?
Dr. Bianchi. Thank you very much for your question, Senator
Murray. As you know, there are almost four million children who
have been infected with SARS-CoV-2, but the key is to figure
out which is the one-in-a-thousand child who is going to get
very sick with this MIS-C, and that child could get critically
ill, although most do recover. So, as a parent, you would want
to know if my child tests positive, what is going to happen.
And, so, as part of the RADx RAD program--NIH is supporting
this. It is four different programs CARING for Children with
COVID, but the predictive one that is using artificial
intelligence and machine learning is called the PreVAIL Kids
Program. And what that is, is it is eight different programs
around the Country, with some international partners, that are
using existing cohorts, as well as prospectively enrolled
cohorts, to collect biospecimens and use artificial
intelligence in conjunction with the electronic health records.
The program started within the past few months, so we do
not have evidence yet. But, the enrollments are on target, and
we are expecting to enroll about 12,000--actually, we have
already enrolled about 12,000 children out of 16,000 that are
expected.
A.I. DETECTION OF CANCERS
Senator Murray. Okay. And Dr. Sharpless, artificial
intelligence has been shown to help improve the detection of
breast cancer in mammograms, and lung cancer in CT scans. And
suggesting that AI appears well suited for imaging, are you
looking at the potential for AI to help early detection of
other cancers?
Dr. Sharpless. Oh, yes. This is a very important topic. I
think artificial intelligence has really the ability to
transform cancer research and cancer clinical care in dramatic
ways.
We have a very lively set of collaborations going on with
the Department of Energy that has extensive expertise in this
topic. To use, you know, AI to try and identify drug targets
for medicinal chemistry, or to use AI to read 600,000 pathology
reports that we get for the SEER database every year, or to use
artificial intelligence for image analysis, both pathology
images and radiology images.
So, I think this is a tremendously exciting technology that
has real opportunities to advance cancer research and cancer
care in many important ways.
I think we were also worried about the ethical issues of
AI, and we want to make sure that we use practices that will
not reinforce biases that are latent in some of our data sets.
But, overall, I think the promise of AI is very exciting
for cancer research.
Senator Murray. Interesting. Okay.
CLIMATE CHANGE AND HEALTH
Dr. Gibbons, the request, budget request, includes $110
million to study the impact climate change is having on health.
Talk to us about what kind of serious effects have we been
seeing from climate change, and what kinds of research do you
expect NHLBI (National Heart, Lung, and Blood Institute) to
support with this kind of funding?
Dr. Gibbons. Yes. Thank you for that question. As we know,
climate change often involves these changes in our air, in our
air quality, particularly it is likely to promote more air
pollution. Certainly, the constituents on the West Coast are
familiar with the impact of wild fires on air quality.
And although air is all around us, air pollution tends to
concentrate and have its greatest impact on certain
communities, particularly communities in which those
neighborhoods are closer to sources of air pollution, and
therefore, the impact is also inequitable in terms of the
health consequences of air pollution, and that is falling on
the most vulnerable.
We know that it exacerbates certain chronic conditions,
certainly cardiopulmonary ones like chronic obstructive
pulmonary disease, asthma, heart failure. Heart attacks are
increased in the context of higher air pollution promoted by
climate change.
And, we anticipate that there will be a need to not only
mitigate the impact of climate change, but also to enhance
resilience to the effects of air pollution on health, and we
anticipate that that will involve enhancing healthy communities
that are disproportionately affected by the consequences of air
pollution derived from climate change. And our programs that
are community-engaged research with that health equity lens
should be promising in that regard.
Senator Murray. Okay. I think this is really important, and
I think we all should recognize that this is an area we need to
look at, so I appreciate your work on this and we will be
following it closely.
I will turn to----
SEXUAL HARASSMENT AT NIH
Okay. I have one additional question and that is for Dr.
Collins. In 2018, the National Academies, as you know, released
a report that found that nearly 60 percent of women in academia
have experienced--60 percent--have experienced sexual
harassment on the job and recommended that Federal research
agencies require institutions to notify them when individuals
on grants have violated harassment policies or put on
administrative leave due to harassment allegation. And other
science agencies, like National Science Foundation, have
implemented these changes.
Tell me, what is NIH doing to require its research
institutes to do the same?
Dr. Collins. Senator, I share the sense that this is an
extremely important issue. The National Academy report that you
mentioned I think really got everybody to recognize how
pervasive sexual harassment is and what a significant negative
it has been for far too long for women in our scientific
workforce.
We conducted our own working group in the Advisory
Committee to the Director that reported to me in December of
2019 and made a series of very significant recommendations
about how we might change our approach to this. We have been
working through those and have already implemented a
significant fraction of them. There are some that still require
some additional legal authority that is hard for us to be able
to do at the present time.
In terms of what you are particularly pointing to, we have
had now more than 300 allegations that have been brought to us
about sexual harassment in our grantee institutions; others
within our own intramural program. Of those 300, about 30
percent of them have turned out to be actually entirely
validated. That has resulted in a hundred different changes in
grants that--particularly, removal of principal investigators
and replacement of those with other individuals.
One hundred and twenty-five individuals have been taken out
of our pool of peer reviewers because of this kind of concern
about the bias that they bring to that experience.
And we have made it very clear to our institutions that we
expect them to report any circumstance----
Senator Murray. Well, expecting them does not require them
to.
Dr. Collins. And, Senator, you and I are in an interesting
discussion here that I agree--I wish we were able to simply say
require. At the present time, legally, we are told we do not
have that authority. We would have to go through a 2-year
rulemaking effort, or we would need statutory assistance.
Senator Murray. Well, okay. This is really important, and
whatever we need to do, I do not--you know, I know you have
worked on it, I know you have focused on it, but I know of
women who have left our scientific research institutes because
of this. We cannot afford to have that happen for a thousand
reasons. So, whatever it is we need to do here, we need to know
what it is so we can do it.
Dr. Collins. I am so with you. And if there is another
iteration we can take at this to try to figure out--I will say
that what we have said in terms of the expecting response from
our institutions has gotten their attention in a pretty
remarkable way. Even without requiring it, we are seeing
reporting coming through.
Senator Murray. Well, to every one of them that is
listening, I am not done with this.
Dr. Collins. Okay.
Senator Murray. Senator Blunt.
Senator Blunt. Thank you, Chair.
I have three or four questions. Let me eliminate a couple
of other topics by just making a couple of comments on some
things that have already been said, one, and one thing that has
not been, I do not believe, brought up today.
One is on the CTSA awards. None of the people talking to us
that are current recipients think that this simplifying the
process makes it more likely that they will get the research
bench-to-bedside result that they think you want and they think
is the key to this award.
And, you have heard a number of schools mentioned, and
University of Washington would be one of them that Senator
Murray would be very familiar with. Washington University in
St. Louis collaborates through this program with Saint Louis
University and the University of Missouri to get to more rural
hospital settings and do things. So, I suspect you have heard a
number of concerns about that today.
I have not heard brought up one of my concerns, which I am
just going to mention. I do not think you need to respond to
it. I do think that waiving the intellectual property rights on
COVID-19 vaccines is a problem. I think it is a problem because
I do not think it actually would increase the number of
vaccines, the capacity to produce a vaccine that has efficacy,
in the timeframe we need to make it. It probably is not
benefitted much by waiving the rights to the research. The WTO
(World Trade Organization) has to unanimously agree, which I do
not think they do. But, if they do, we give our research to
everybody.
And third, when this comes up again, companies would have
less willingness, I think, to step forward. At least one of the
companies, Dr. Collins that we dealt with in Warp Speed, there
was no agreement at all that if they were not successful--we
had a contract. We would buy 100,000 doses, but only if they
were FDA authorized. So, they were out there totally on their
own, as these companies you would expect to be.
I do not think this is likely to happen because of the WTO,
but I have some concerns that I suspect are shared by others at
NIH.
IMPACT OF COVID-19 PANDEMIC ON CHILDHOOD DEVELOPMENT
Dr. Bianchi, just the title--let's just take the title of
your Institute and look at COVID. What do you think the impact
on child health and development of COVID and the COVID
environment, the pandemic environment, the quarantine
environment, has been? And how are we going to be looking at
what the long-term ramifications of that might be and what
advice we may be able to give to schools and moms and dads and
behavioral health and other health providers as it relates to
child development impacted by this?
Dr. Bianchi. Thank you so much for that question, Senator
Blunt, because children, you know, have not--I think they are
so important in terms of our Nation's future, first of all.
But, the fact that children have been home from school has
affected the entire family, has affected the workforce, et
cetera.
But, because children in general have been asymptomatic or
mildly symptomatic, they have not gotten as much attention, and
yet being at home, being away from in-person schooling, I think
may have significant impact for years to come. And, for that
reason, we are trying to get the kids back to school as soon as
possible.
And as part of the RADx Underserved Population program, we
are also leading an initiative to really develop, evaluate, and
implement testing, along with mitigation, of, you know, hand
washing, social distancing, et cetera, to get evidence to
reassure people to get kids back to school. Two of the sites
are actually in Missouri, and one is in Washington State. There
is a program in Yakima, and there is a special program in
Missouri that is looking at how you deal with kids who have
intellectual disabilities and cannot mitigate in the same way.
So, to answer your question, I think there will be long-
term effects. I think the answer is to get kids back to school
safely, with evidence. And, this program is based on a funded
project that was very successful in North Carolina that showed
with all the mitigation, with the work with the superintendents
of schools, that the secondary infection rate in schools was
extremely low compared to the community.
Senator Blunt. Yes. I would think here that some of the
developmental issues, and they will be different with 4 and 5
year olds and kindergarten and first grade than they will
people in seventh grade, and those may be different than
people----
Dr. Bianchi. Absolutely.
Senator Blunt [continuing]. In the eleventh and twelfth
grade and how--you know, I think we are going to have to watch
this carefully and try to get data and then share that data.
FUTURE OF MRNA TECHNOLOGY
On vaccines--actually, on--maybe more on mRNA than
vaccines, what do we think the impact may be as it relates to
cancer, to HIV? We will start, Dr. Fauci, with you. Can we look
at the flu shot in a different way? And what do we think the
mRNA impact, now that we know this different use for it, may
have on other healthcare settings? And Dr. Sharpless, I am
going to come to you second on this.
Dr. Fauci. It is going to--I believe, and many of my
colleagues believe, that the mRNA technology, as it has been so
spectacularly successful with SARS-CoV-2 to develop a vaccine
against COVID-19, is already being pursued for other
infections, including HIV and including influenza. So, there
are a couple of things that are going on now. Even as we see
the successes with COVID-19 in using the mRNA technology for
the development, for example, of universal flu vaccines, as
well as now having HIV vaccine researchers now looking at the
possibility of an mRNA platform technology to use for HIV. So,
it is already happening.
Senator Blunt. Dr. Sharpless, on mRNA, I mean, we know the
impact in just the last half dozen years of immunotherapy on
cancer treatment. What about this mRNA intervention and how it
might impact the way we look at fighting cancer?
Dr. Sharpless. Yes, this is a very exciting topic. You
know, people interested in this space have been working on
this, you know, long before the pandemic. So, using mRNA for
cancer therapy has many potential applications because you can
really get the body to make a protein, and that protein could
have a desirable effect against cancer, for cancer therapy, in
a lot of ways.
The furthest advance, as you mentioned, is the use of mRNA
vaccines, you know, cancer vaccines. And clearly, they tend to
be highly personalized, the ideas that you can sequence
someone's own tumor and then make the vaccine to their very own
tumor in a way that will not cause them autoimmune side
effects, and this is an idea to augment other kinds of
autoimmune cancer--or anti-immune cancer therapies.
So, it is a very promising area. It is in clinical trials,
and we just need to see how this develops.
Senator Blunt. Thank you. My last question, Chair.
IMPACT OF COVID-19 PANDEMIC ON RESEARCH AND RESEARCHERS
Dr. Collins, in the pandemic, particularly with lab
closings, we obviously lost some time, and lost research that
is going to take a long time to recreate. Are the lab
reopenings happening in the way they need to? And, do you have
the flexibility to extend a grant to overcome the disruption?
And probably just not this disruption of the time closed, but
the research lost by closing, as well.
Dr. Collins. I am glad you are asking because this is yet
another of the terrible casualties of this terrible pandemic.
It has been very hard on researchers, especially those who need
a laboratory to do their work or who were running a clinical
trial that was very hard to enroll participants. And, yes, we
did have to have many of those folks staying away from the
workplace for their own safety.
They are coming back. Our own program at NIH, our
intramural program, now is up to about 50 percent occupancy,
but it is not anywhere near where it was pre-pandemic. We have
done everything we can with our flexibilities to try to make
sure, particularly, that trainees and early-stage investigators
do not get further injured by this by extending the periods of
their training; or by allowing grants if they are able to put
forward a special request to be extended for an extra year,
either without extra funds, or with, if the case is strong.
And yes, I also think we need to be cognizant of the way in
which this is affecting people in other ways. We have now come
up with a way to provide childcare support for our trainees who
otherwise have not had that, and that has been one additional
burden on their shoulders.
Our estimates are that it is about a $16 billion loss that
has occurred because of the way in which this has affected
research in our extramural institutions; that they are in a
tough place to try to make up. So, I appreciate your asking the
question.
We are going to have a really big challenge getting
ourselves back into the place that we were before this
happened.
Senator Blunt. Well, let us know what we need to be
thinking about as we think about the rest of this bill on that
topic. And thank you, Chair.
Senator Murray. Thank you very much. And I want to thank
all of our witnesses today for their really--for a really
productive hearing. I think we all learned a lot. So, thank you
very much.
ADDITIONAL COMMITTEE QUESTIONS
For any Senators who wish to ask additional questions,
questions for the record will be due one week after the
President's budget is delivered at 5 p.m. The hearing record
will also remain open until then for members who wish to submit
additional materials for the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted to Dr. Francis Collins
Questions Submitted by Senator Patty Murray
Question. The President's fiscal year 2022 skinny budget proposed a
major new biomedical research effort by establishing ARPA-H. While the
skinny budget was light on details regarding the structure of the
program, the Administration's statement indicated that the initial
focus of ARPA-H would be `on cancer and other diseases such as diabetes
and Alzheimer's.'
Assuming Congress and the Administration work together to establish
ARPA-H, how would you envision ARPA-H setting priorities for research
into additional diseases?
Answer. Over the long term, the proposed structure for the Advanced
Research Projects Agency for Health (ARPA-H) is intended to empower the
ARPA-H leadership and staff to set and execute on research priorities
for a variety of high-risk, high-reward, milestone-driven projects that
can lead to novel capabilities, platforms, and resources that are
applicable to a range of diseases.
For the initial direction, the Administration is working to set up
multiple pathways, both within the government and the broader
stakeholder community, for priority setting and for exploring new areas
ripe for research at ARPA-H. At the time of this hearing, the White
House Office of Science and Technology Policy (OSTP) and the National
Institutes of Health (NIH) are in the planning phases of convening
multiple listening sessions with key stakeholder groups including
patient organizations, industry, venture capitalists and
philanthropists, and others from the academic and research communities.
During these sessions, stakeholders will be asked to offer their
perspective on what they see as the greatest research challenges and
opportunities that could be addressed using the ARPA-H model. This
input will help refine the scope and provide a wealth of ideas for the
first ARPA-H director to consider as they develop the agency's vision.
In mid-July, the Administration established a Joint Fast Track
Action Committee (FTAC) to help steer the creation of ARPA-H and lay
the groundwork for strong interagency coordination. OSTP and NIH serve
as co-chairs of this committee that includes representatives from
Department of Agriculture, DARPA, Office of the Under Secretary of
Defense for Research & Engineering, ARPA-E, BARDA, CDC, CMS, FDA, VA,
EPA, NSF, and the Smithsonian Institution, among others.
Question. Some of the greatest advances in medical innovation in
the last decade have been brought on through genetic analyses and use
of sophisticated computer programs that can shorten the time taking
drug candidates through clinical studies. In fact, the development of
COVID-19 vaccines benefited from the use of 21st century technology
like cloud computing and AI to help stop the virus' spread and save
lives.
How will the President's budget build on the use of modern tools
like cloud computing, AI, and genetic analyses to further accelerate
the delivery of cures to patients?
Answer. Over the last decade, pharmacogenetics has advanced the
frontier of personalized medicine such that drug therapeutics are
developed based on the genetic aberrations of disease. This approach is
most notably applied for cancer treatments and also other diseases.
Cancers of various types are treated by first knowing the genetic
mutations and/or deletion of genes. Then drug candidates are screened
and developed by computer modeling of the target sites along with
potential drug candidates. Such modeling requires various large
datasets and analytics that, if stored in the cloud and interoperable,
can be mined to find the best drug candidates that bind to the target
sites for treatment. Storing large datasets in the cloud is only the
first requirement for cloud computing. Such computation requires new
tools, and support for tool development is essential to realize the
opportunities for cloud computing.
Artificial intelligence (AI) has advanced the pace of drug
discovery and development via predictive models of drug/target
interactions and also facilitates clinical trial design based on
algorithms for go/no go decisions during the trials.
The President's Budget Request supports the application of AI to
improve diagnostics for diseases as diverse as coronavirus disease 2019
(COVID-19) and cancer. In each case, information-rich data sources that
are stored, aggregated together, and analyzed in the cloud are used to
rapidly train and test these new capabilities. New programs like the
Artificial Intelligence/Machine Learning Consortium to Advance Health
Equity and Researcher Diversity program, or AIM-AHEAD, and Bridge2AI
will harness AI for health by generating AI-ready datasets and best
practices for machine learning. This will allow researchers to
accelerate data-driven discovery for grand challenges in biomedicine
using AI-based technologies. Additionally, NIH's partnership with cloud
services providers--Google, AWS and now Microsoft Azure--further
enhances researchers' abilities to leverage industry technologies and
utilize AI-ready data for drug discoveries and therapeutic treatments.
______
Questions Submitted by Senator Richard J. Durbin
Question. I have worked with the Subcommittee Chair and Ranking
Member for years on sustained, predictable increases to the NIH
budget--with the goal of providing at least 5 percent real growth year-
over-year. We have had success, leading to a 42 percent increase over
the past 6 years, along with supplemental funding in COVID-19 relief
packages. The President's fiscal year 22 budget calls for a 19 percent
increase to the NIH overall budget. The vast majority of that comes
from the proposed creation of a new advanced research effort, called
ARPA-H. When I toured the NIH campus recently with many members of this
Subcommittee, you discussed how innovative efforts during the
pandemic--such as with the RADx testing program or Warp Speed vaccine
development--align with the ARPA-H proposal, incorporation closer
partnerships with industry and coordination at different stages in the
research and development of promising breakthroughs. Your testimony
discusses application of this nimble ARPA-H proposal for cancer,
infectious diseases, and autoimmune diseases.
As we evaluate this proposal, what are the core aspects of this
ARPA-H policy that you want us to keep in mind?
Answer. We envision that the Advanced Research Projects Agency for
Health (ARPA-H) will be able to tackle large-scale challenges using a
proven high-risk, high-reward approach that embraces nimbleness and
flexibility with the broader goal of delivering rapid breakthroughs
that serve all patients. Being successful in this endeavor requires
close communication and collaboration across government and with key
stakeholders in the external biomedical community. This could include
undertaking projects with Federal agencies, private companies,
independent research institutes, medical centers, as well as academic
institutions--all collaborating to advance innovative health research.
NIH deployed similar approaches in response to the COVID-19 pandemic
(Accelerating COVID-19 Therapeutic Interventions and Vaccines, or ACTIV
and Rapid Acceleration of Diagnostics, or RADx)--which yielded life-
saving results for Americans, and also served as a learning opportunity
to appreciate further the value of employing a DARPA--like model to
support research. With Congressional support, we believe we can
leverage these models in other areas of health research to drive
transformative change and impact.
Question. We have spoken in the past about two seemingly divergent
issues. On one hand, we talk about the need to invest in medical
research to find breakthroughs and cures for patients, so we rightfully
appropriate billions into NIH-funded research--sign me up for that. But
then these drugs come to market--the vast majority of them benefitting
from NIH research (e.g. a study finding that all 210 drugs approved by
FDA between 2010 and 2016 benefitted from NIH-funded research in some
form)--and too many of them with exorbitant price tags. Recent studies
show that high costs contribute to poor medication adherence, including
with one-quarter of cancer patients choosing not to fill a prescription
due to cost. I know Dr. Sharpless has talked about the ``financial
toxicity'' for cancer patients. Americans pay the highest prices for
medications in the world, with a recent GAO report finding that the
U.S. pays two- to four-times more for certain medications than other
developed countries. It is counterintuitive and an outrage that
taxpayers fund cutting-edge research, which leads to drugs, that we
often cannot afford once they hit the market. I understand NIH does not
set drug prices and does not want to limit the handoff or development
of its research to stakeholders that commercialize the discoveries. But
the current system does not maximize the benefits for patients.
Given the role of NIH research in contributing to FDA-approved
medications, many of which come with extremely high price tags, what
specific steps can NIH take to ensure that patients are able to afford
the incredible discoveries made at NIH?
The NIH has received several petitions to exercise march-in rights
(35 U.S.C. Sec. 203), but has never done so.
--Under what circumstances would NIH consider doing so?
--Under that statutory authority, how does NIH define and evaluate
the term ``practical application'' for the purposes of how a
contractor or assignee makes a subject invention funded by NIH
available to the public on reasonable terms?
--What are the factors used in such definition and evaluation?
--Can you provide an example of the analysis undertaken in evaluation
of a previously filed march-in-petition?
Answer. The National Institutes of Health (NIH) shares your concern
about the high price of drugs and the impact on public health. The
article you reference shows that all of the 210 drugs approved by U.S.
Food and Drug Administration from 2010 to 2016 were based on at least
one scientific publication reporting on research funded by the NIH.\1\
The researchers reported that 96 percent of the NIH funded projects
were identified based on a search for the ``target'' rather than the
drug itself. Identifying a drug target, meaning a protein in a cell
that has a function in a disease process, opens the door for any
researcher in industry or academia to screen for drugs that bind to the
target to slow or arrest disease processes. This research is key to a
vibrant drug discovery process in the United States and does not limit
discovery to one drug for each target. The development of multiple
drugs for a particular disease allows the patient and physician to
choose the best one for them and can lead to price competition in the
market. Drug pricing is a complex problem that involves various
segments of the market, much of which NIH has no control over. A
smaller number of important drugs utilize patented inventions funded by
the NIH. When NIH has been asked to consider march-in under the Bayh-
Dole Act based on the price of such drugs, NIH has stated that the
issue of drug pricing is one that should be address by Congress, as it
considers these matters in a larger context.\2\
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\1\ Cleary et al., 2018, www.ncbi.nlm.nih.gov/pmc/articles/
PMC5878010/.
\2\ NIH march-in responses from 1997-2013 at ott.nih.gov/policy/
policies-reports under ``NIH March-In Response''.
---------------------------------------------------------------------------
The Bayh-Dole march-in provision (See 35 U.S.C. 203) allows a
government funding agency to require a grantee to grant a license to a
patent of an invention made under that agency's awarded grants or
contracts and allows other ``responsible applicants'' to obtain the
license if one of four circumstances are met:
1. the contractor or assignee has not taken, or is not expected to
take within a reasonable time, effective steps to achieve practical
application of the subject invention in such field of use
2. to alleviate health or safety needs which are not reasonably
satisfied by the contractor, assignee, or their licensees
3. to meet requirements for public use specified by Federal
regulations and such requirements are not reasonably satisfied by the
contractor, assignee, or licensees
4. the agreement required by section 204 [a requirement that
patented products be manufactured substantially in the United States
unless a waiver is granted]
The first two criteria are typically cited in petitions to consider
a march-in by the National Institutes of Health (NIH). For example, if
a company has rights to a government funded patent for a drug candidate
but is not making reasonable efforts to bring it to market, the company
may be failing to meet the requirements to achieve practical
application of the invention. These criteria are considered on a case-
by-case basis by the agency in view of the facts presented in each
case.
If NIH were to march-in, the grantee could appeal that decision
through the Federal courts. Only after the company had lost all legal
appeals could NIH grant a license to a second company, should there be
one interested in developing a new version. Additionally, the drug
could be covered by other patents that cover certain aspects of the
drug, such as methods of making and administering it. In such
instances, the march-in could be ineffective, because the original
company could stop a new company from making the generic until the
other patents expire.
After the court appeals and expiration of any other patents, a
company would typically have to conduct clinical trials or otherwise
establish equivalency with the brand drug to obtain U.S. Food and Drug
Administration approval. The entire process, including administrative
hearings, court appeals and new clinical trials, could take years
before the new product reached the market. In the meantime, alternative
therapies may have become available or the patent subject to march-in
may have expired.
NIH has considered march-in on several occasions and was either
able to work with parties to reach an agreement to address the issues
raised, such as the case with CellPro and Fabrazyme, or decided that
the march-in legal requirements were not met to march-in to address the
public health and safety issues raised, such as was the case with
Norvir.\3\
---------------------------------------------------------------------------
\3\ See ott.nih.gov/policy/policies-reports under NIH March-In
Response.
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Question. The COVID-19 pandemic has impacted every major sector of
the economy of the United States, including our nation's biomedical
research. I have heard from countless universities across the state of
Illinois about the impact that this pandemic has had on the medical
research pipeline. From shuttered labs, to interrupted or delayed
clinical trials, to unforeseen pandemic-related costs, they have
estimated that this pandemic has caused over $10 billion in lost
research. Last year, Senator Moran and I sent a bipartisan letter to
Senate leadership, requesting at least $10 billion in additional
funding to help make-up for the unforeseen disruptions and costs to
medical research nationwide.
Dr. Collins, I am wondering if you can speak to the toll that the
pandemic has taken on medical research nationwide and what Congress
might be able to do to help.
Answer. The National Institutes of Health (NIH) remains deeply
concerned and mindful about how the spread of coronavirus disease 2019
(COVID-19) has negatively affected the biomedical research
enterprise.\4\ Last summer, the NIH estimated it would cost at least
$10 billion to restart labs which were forced to rapidly close. That
original estimate proved overly optimistic as the pandemic subsequently
continued, and as such, the NIH now estimates the financial impacts to
be approximately $16 billion on the biomedical and behavioral research
enterprise.
---------------------------------------------------------------------------
\4\ https://nexus.od.nih.gov/all/2020/11/04/continued-impact-of-
covid-19-on-biomedical-research/.
---------------------------------------------------------------------------
The estimates considered many factors:
--Key resources, such as animal colonies, cell lines and expired
reagents that need to be re-established.
--Access to core facilities that was limited due to a backlog of
requests.
--Delicate and complicated equipment that required recalibration and
quality control testing prior to returning to routine use.
--Requirements for social distancing to protect staff and clinical
trial participants coupled with anticipated reluctance by
participants to travel, which slowed the rate of clinical trial
accrual and progress and increased the cost of conducting
trials.
In addition to the financial estimates, the NIH fielded two online
surveys to objectively document COVID-19's impact on the extramural
research workforce.\5\ The main finding from the surveys was that the
majority of respondents noted concerns about research functions,
research productivity, and financial status.\6\ Well into the pandemic,
many NIH-supported research labs enforced social distancing, inherently
restricting access and severely limiting the ability to generate
research results and preliminary data at a crucial time in career
development of early stage investigators and trainees. Junior faculty,
often with only a single NIH award and unable to access their labs to
generate additional data, are at risk of losing all funding and may
have insufficient data to write papers while working from home. Some
investigators, especially women with dependent care responsibilities,
are more negatively affected. Investigators supported by training or
career development awards are experiencing hiring freezes and job
revocations, jeopardizing the ability of early-stage career
investigators to transition to independence, particularly as they come
to the end of their current funding. Clinical investigators have been
diverted from their research labs to meet the clinical demands of
COVID-19 patient care.
---------------------------------------------------------------------------
\5\ https://nexus.od.nih.gov/all/2020/10/05/encouraging-
participation-in-upcoming-nih-surveys-to-identify-impacts- of-covid-19-
on-extramural-research/.
\6\ https://nexus.od.nih.gov/all/2021/03/25/the-impact-of-the-
covid-19-pandemic-on-the-extramural-scientific-workforce-outcomes-from-
an-nih-led-survey/.
---------------------------------------------------------------------------
Considering these effects, the NIH is concerned about potential
pandemic-related losses of scientists exiting the biomedical research
workforce and abandoning scientific careers to seek alternative
employment. In an effort to address the unanticipated impacts of the
pandemic on the career trajectories of early career scientists, the NIH
has provided several policy flexibilities, including grant award
extensions (both funded and un-funded), opportunities for investigators
to extend the timeline for early career status, provided administrative
supplements, and more.
______
Questions Submitted by Senator Brian Schatz
Question. At the hearing, we discussed psychedelic drug research
and the potential of these drugs to treat mental health illness. You
stated that the NIH would consider having a workshop on this subject.
What is the current status of NIH-funded clinical trials involving
human subjects on the potential benefits of psychedelics combined with
psychotherapy?
Are there statutory or regulatory barriers to NIH pursuing or
funding human subject research on psychedelic drugs?
When does NIH plan to convene a workshop on psychedelic drug
research?
Answer. The National Institutes of Health (NIH) supports research
on the development and testing of pharmacological interventions--
including the use of hallucinogens such as ketamine, and psychedelic
drugs such as psilocybin--for the treatment of illnesses. In
particular, the National Institute of Mental Health (NIMH) requires an
experimental therapeutic approach for the development and testing of
therapeutic interventions for mental illnesses, in which the studies
not only evaluate the clinical effect of an intervention, but also
generate information about the mechanisms underlying a disorder or an
intervention response. Research on psychedelic drugs holds promise for
uncovering mechanisms of mental illnesses and possible interventions,
ultimately leading to novel treatments with fewer side effects and
lower abuse potential. Further research is needed to examine the
efficacy and long-term safety of psychedelic drugs, including with
repeated exposure and potential interactions with existing treatments.
The dissociative anesthetic ketamine has recently emerged as an
effective fast-acting antidepressant.\7\ The NIMH Director's Message,
``New Hope for Treatment-Resistant Depression: Guessing Right on
Ketamine,'' describes the role of NIMH and other researchers in the
development of esketamine, a U.S. Food and Drug Administration-
approved, rapid-acting medication that targets treatment-resistant
depression.\8\ Within the NIMH Intramural Research Program, Dr. Carlos
Zarate is now conducting clinical trials to better understand how
ketamine rapidly reduces depressive symptoms in people with treatment-
resistant depression or bipolar depression.\9,10\
---------------------------------------------------------------------------
\7\ pubmed.ncbi.nlm.nih.gov/27839782/.
\8\ www.nimh.nih.gov/about/director/messages/2019/new-hope-for-
treatment-resistant-depression-guessing-right-on- ketamine.
\9\ clinicaltrials.gov/ct2/show/NCT03065335.
\10\ clinicaltrials.gov/ct2/show/NCT03973268.
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The National Institute on Drug Abuse (NIDA) currently supports a
clinical trial which aims to assess the efficacy of ketamine, in
combination with behavioral therapy, in the treatment of cocaine use
disorders.\11\
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\11\ clinicaltrials.gov/ct2/show/NCT03344419.
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Additionally, a privately funded clinical trial is assessing the
potential efficacy of the psychedelic drug psilocybin for the treatment
of obsessive-compulsive disorder.\12\ While the NIH is not directly
funding this trial, NIMH does support the trial's principal
investigator through a Mentored Patient-Oriented Career Development
Award.\13\
---------------------------------------------------------------------------
\12\ clinicaltrials.gov/ct2/show/NCT03356483.
\13\ reporter.nih.gov/project-details/10127338.
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Further, a number of NIH-funded researchers are conducting basic
and preclinical research to investigate the use of psychedelic drugs as
potential therapeutic interventions for mental illnesses. For example,
NIMH-funded researchers are examining the mechanisms underlying the
antidepressant effects of psychedelic drugs in an effort to develop
novel, non-hallucinogenic treatment strategies that are both safer and
more effective than existing treatment options.\14\
---------------------------------------------------------------------------
\14\ reporter.nih.gov/project-details/10003396.
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As with all human subjects research, clinical research on
psychedelic drugs is governed by several statutes, regulations, and
policies intended to protect the rights and welfare of research
participants. For example, NIH has specific requirements for research
staff and policies regarding research conduct, safety monitoring, and
reporting of information about research progress.\15\ In accepting an
award that supports human subjects research, the recipient institution
assumes responsibility for all research conducted under the award,
including protection of human subjects at all participating and
consortium sites.\16\ All human subjects research must also be
reviewed, approved, and monitored by an Institutional Review Board.\17\
---------------------------------------------------------------------------
\15\ grants.nih.gov/policy/humansubjects/policies-and-
regulations.htm.
\16\ grants.nih.gov/grants/policy/nihgps/html5/section_4/
4.1.15_human_subjects_
protections.htm.
\17\ www.fda.gov/regulatory-information/search-fda-guidance-
documents/institutional-review-boards-frequently-asked-questions.
---------------------------------------------------------------------------
Because psychedelic drugs are controlled substances, clinical
research using psychedelic drugs must also follow Drug Enforcement
Administration requirements, including registration, inspection, and
certification of the drugs.\18\
---------------------------------------------------------------------------
\18\ grants.nih.gov/grants/policy/nihgps/html5/section_4/
4.1.5_controlled_substances.htm.
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From April through June 2021, the Trans-NIH Integrative Medicine
Course Organizing Committee hosted a series of research talks on
psychedelic drugs.\19\ Building on these research talks, NIMH and NIDA
are now working together to convene a scientific workshop in winter
2021. This workshop will bring together leading researchers to examine
the state of the evidence for the use of psychedelics in the treatment
of mental illnesses.
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\19\ events.cancer.gov/nci/psilocybinresearch/agenda.
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Question. The United States shares a unique political relationship
with the Native Hawaiian community. Different Federal agencies within
HHS are responsible for the administration of Native healthcare
programs, but the same Federal trust responsibility requires the
provision of comprehensive, quality healthcare to Native Hawaiians,
Alaska Natives and American Indians. In 2015, NIH established the
Tribal Health Research Office within the Office of the Director to
coordinate tribal health research activities across NIH. However, no
such research office exists for Native Hawaiians.
Would you consider expanding the scope of the Tribal Health
Research Office to include Native Hawaiians? Would this help to
increase the number of Native Hawaiian researchers and the amount of
Native Hawaiian research being conducted across the country?
Has NIH set any goals for the Tribal Health Research Office, and
how will you measure its success and impact across NIH's Institutes and
Centers?
Some funding opportunities at NIH, such as the Native American
Research Centers for Health program, do not permit entities serving
Native Hawaiian communities to apply. Why are these entities excluded,
and would NIH consider including these entities in the eligibility for
these grant opportunities?
Answer. The National Institutes of Health (NIH) Tribal Health
Research Office (THRO) does not conduct disparity research on Native
American populations. THRO ensures that the NIH fulfills its
obligations to Indian Tribes as federally recognized sovereign nations,
conducts government to government interactions appropriately, and holds
formal Consultations with Tribal governments on policy, regulatory, and
legislative issues that have a significant direct impact on Indian
Tribes.
The National Institutes of Health (NIH) published the NIH Strategic
Plan for Tribal Health Research with input from American Indian/Alaska
Native (AI/AN) Communities and the NIH Tribal Advisory Committee (TAC).
The plan includes four agency-wide strategic goals: enhancing
communication and collaboration; building research capacity for AI/AN
communities; expanding research; and enhancing cultural competency and
community engagement. The Tribal Health Research Office (THRO), along
with the NIH Institutes and Centers (ICs), developed processes and
metrics for evaluating progress on the strategic objectives and their
supporting action items to achieve these goals. THRO regularly collects
data on AI/AN health research activities from all ICs through an
automated process to analyze the NIH research portfolio, assess
progress towards the strategic goals, and measure impact across NIH.
The National Institute of General Medical Sciences in conjunction
with multiple NIH Institutes, Centers, and Offices (ICOs) partner with
Indian Health Service (IHS) to support the Native American Research
Centers for Health (NARCH). NARCH grant applications are submitted by
and awarded to a tribe or tribal organization, who are sovereign
nations with distinct governing bodies. Awarding the grant directly to
the tribe or tribal organization allows for the community to dictate
and oversee research priorities, while drawing upon necessary expertise
from the research community to accomplish its scientific goals.
______
Questions Submitted by Senator Joe Manchin, III
Question. West Virginia is consistently ranked last in the nation
for health outcomes. In 2020, the America's Health Rankings Report
ranked West Virginia 50th for premature deaths, frequent mental
distress, and multiple chronic conditions. We also rank last in life
expectancy. West Virginia has, in many ways, been left behind as
medical advances have saved lives in other places.
What is NIH doing to bridge this gap in health outcomes?
How do you ensure that the medical research that you do benefits
people in poor, rural communities?
How can we better expand the access rural Americans have to
successful medical treatments, particularly in states like mine where
the disease burden is so high?
Answer. The National Institutes of Health (NIH) recognizes the
unique health disparities that rural communities face, and as such,
rural health is an important area of research for the agency.
Through diverse collaborations and partnerships with communities,
academic institutions, and state agencies, NIH supports and conducts
rural health research to improve health outcomes and reduce rural
health disparities with a special emphasis on the poor in rural
communities. In fiscal year 2020, NIH supported more than 1,000 rural
health-related grants for approximately $728 million. In 2020, West
Virginia received approximately $45.7 million in funding from NIH, of
which about $6.4 million supported research and research capacity-
building activities related to rural health.
In 2019, NIH held the Inaugural NIH Rural Health Seminar, a
collaboration of several NIH Institutes and Centers to explore topics
in rural health and opportunities for research collaborations to
improve rural health outcomes. In 2020, NIH hosted a virtual rural
health conference entitled, NIH Rural Health Seminar: Challenges in the
Era of COVID-19. In October 2021, NIH will host the Pathways to
Prevention Workshop: Improving Rural Health Through Telehealth-Guided
Provider-to-Provider Communication, a virtual event to identify
research gaps, explore barriers, and facilitate successful, sustainable
implementation of provider-to-provider telehealth in rural settings.
NIH's rural health research focuses on key areas aimed at
addressing health disparities that rural populations in West Virginia
and around the United States experience. In fiscal year 2020, in
response to the disproportionate impact of coronavirus disease 2019
(COVID-19) on racial and ethnic minority, and other vulnerable
communities including rural populations, NIH established the Rapid
Acceleration of Diagnostics for Underserved Populations (RADx-UP)
initiative. The overreaching goal of the RADx-UP initiative is to
understand the factors associated with disparities in COVID-19
morbidity and mortality and to lay the foundation to reduce disparities
for those underserved and vulnerable populations more impacted by
COVID-19. One example of a RADx-UP project in your state, is the
Developing Novel Strategies to Increase COVID-19 Testing among
Underserved and Vulnerable Populations in West Virginia through
Community and State Partnerships. This project will implement
collaborative strategies to increase availability and uptake of severe
acute respiratory syndrome coronavirus 2 (SARS CoV-2) testing among the
medically underserved, rural West Virginia population that includes
multiple vulnerable groups at risk for severe COVID-19 and death. This
initiative will test whether those implemented strategies, including
home test kit and mobile unit mechanisms, successfully increase
testing, and if not, determine why the interventions did not work to
inform future sustainable testing policy.
In addition, NIH supports the West Virginia University Health
Sciences TME CoBRE project, which focuses on the microenvironment of
different tumor types, including cancers initiating in the bone marrow,
head and neck, breast, and brain. This project will increase
understanding of the constant interaction between the tumor and its
environment, provide diverse training opportunities and mentoring
strategies for junior faculty, and develop critical infrastructure and
recruit additional tumor microenvironment focused scientists to West
Virginia. Another project, the West Virginia Clinical and Translational
Science Institute: Improving Health through Partnerships and
Transformative Research (WVCTSI), leads statewide collaborations and
innovation in clinical and translational research. This project will
build sustainable research infrastructure, recruit clinician scientists
and translational researchers that excel in team science, and actively
engage with multiple stakeholders that include communities, medical
providers, and policy makers to improve the health of West Virginians.
NIH is committed to ensuring that there are opportunities for poor
rural Americans to access the benefits of research and that research
addresses the unique strengths and challenges of rural communities by
supporting several initiatives focused on human immunodeficiency virus
(HIV), cardiovascular disease, cancer, drug addiction, and other
chronic diseases disproportionately affecting rural communities. First
announced in April 2018, the NIH Helping to End Addiction Longterm\SM\
Initiative, or NIH HEAL\SM\ Initiative, is an expansive agency-wide
effort. It spans basic, translational, clinical, and implementation
science and promotes collaborations of all types of research to address
the crises of opioid misuse, addiction, and overdose in the United
States. Launched in fiscal year 2020, Strategies to Improve Health
Outcomes and Reduce Disparities in Rural Populations supports research
to promote a greater understanding of the challenges faced by rural
populations in developing or adapting evidence-based interventions that
can reduce health risks faced by rural Americans. A total of eight
awards were funded including: Harnessing the Power of Peer Navigation
and mHealth to Reduce Health Disparities in Appalachia which is using a
community-based approach to integrate peer navigation and mobile health
strategies to develop a culturally congruent, bilingual intervention to
increase the use of HIV, sexually transmitted infection, and Hepatitis
C prevention and care services among individuals with health
disparities living in rural Appalachia. Another study, Heart of the
Family: A Cardiovascular Disease and Type 2 Diabetes Risk Reduction
Intervention in High-Risk Rural Families is examining the effects of a
family focused, lifestyle intervention that is culturally tailored for
use with rural Hispanic or Latino and non-Hispanic or Latino adults. In
2020, the National Institute on Minority Health and Health Disparities
(NIMHD) funded four rural Resource Hubs to focus on rural health
research. These hubs will involve coalitions of researchers and
community partners to build research capacity in an identified rural
catchment area and offer opportunities to share resources and data
across collaborators.
NIH continues to support the Accelerating Colorectal Cancer
Screening and Follow-Up Through Implementation Science (ACCSIS)
Program, a Cancer Moonshot? Initiative, designed to reduce cancer
screening disparities. The aim is to identify evidence-based
interventions and identify promising approaches for bringing these
interventions to unscreened populations. Researchers test interventions
such as mailing programs for home testing, provider education, and
clinic-based patient navigation among Medicaid, rural, and racial and
ethnic minority groups. In fiscal year 2020, NIH reissued and released
the Pragmatic Research in Healthcare Settings to Improve Diabetes and
Obesity Prevention and Care funding opportunity announcement. This
initiative aims to improve diabetes and obesity prevention and/or
treatment that are adapted for implementation in healthcare settings
where individuals receive routine medical care. One of the funded
grants, Telemedicine for Reach, Education, Access, Treatment and
Ongoing Support (TREAT-ON), is a diabetes educator-driven, primary
care-based telemedicine model that redesigns primary care practice to
provide access to real-time ongoing support and help high risk
participants in an underserved rural community to achieve and sustain
improvements in clinical, psychosocial and behavioral outcomes. The NIH
Minority Health and Health Disparities Strategic Plan 2021-2025 aims to
test best practices for dissemination and implementation of minority
health and health disparities research in diverse diseases and
conditions into rural communities.
Continued collaborations and partnerships with scientists and
organizations from rural communities, such as West Virginia, will
contribute to NIH's reach in rural communities and support our work to
combat rural health disparities.
Question. The NIH funds the WV Clinical and Translational Science
Institute at West Virginia University through a 5-year $20 million
grant. The Institute provides critical health research across West
Virginia and has successfully mentored early career investigators,
established pilot project funding, and created a research network
across 27 primary care sites. Their research has focused on important
health issues in my state including lung disease in coal miners, opioid
addiction, and the hepatitis C epidemic, as well as cancer, heart
disease, and stroke. Most recently, the Institute has been on the front
line of COVID-19 research, having received a $1.5 million NIH Grant to
lead an 8-state effort so that data from COVID-19 patients could be
analyzed to develop the most impactful COVID-19 research. They're also
responsible for utilizing the NIH RADx grant to scale up COVID-19
testing in WV Communities.
Can you comment on the importance of continued collaboration
between the NIH and research institutions like the WV Clinical and
Translational Science Institute at West Virginia University?
What more can we be doing to support young researchers, such as
those mentored through this Institute?
Answer. One of the core programs supported by the National
Institute of General Medical Sciences (NIGMS) Institutional Development
Award (IDeA) is the IDeA Networks for Clinical and Translational
Research (IDeA-CTRs), which includes the West Virginia Clinical and
Translational Science Institute (WV CTSI). The IDeA-CTR network aims
to:
--Support the development and/or enhancement of infrastructure and
human resources required to address clinical and translational
research needs in IDeA-eligible states and jurisdictions;
--Strengthen clinical and translational research that addresses the
broad spectrum of health challenges faced by populations in
IDeA-eligible regions; and
--Foster and coordinate collaboration in clinical and translational
research within an IDeA-CTR network and with other
institutions.
Strengthening and expanding the capacity for clinical and
translational research in IDeA-eligible states is a pressing need,
since health conditions such as obesity, diabetes, cardiovascular
diseases, cancer, infectious diseases, chronic obstructive pulmonary
disease, maternal health issues, and substance use disorders are
disproportionally present in and borne by communities in these states.
The IDeA-CTR networks support health research professionals who have
first-hand knowledge of these challenges in order to understand and
improve the health outcomes of residents in affected jurisdictions.
Having the WV CTSI in place during the coronavirus disease 2019 (COVID-
19) pandemic, for instance, has allowed it to act as a springboard for
West-Virginia-based research aimed at studying and addressing the
virus. The $1.5 million supplemental award referenced in this question
facilitated the development of an eight-state consortium that created
an IDeA State COVID-19 Patient Registry. Through the collaboration
between the NIH and WVU, the Registry has become a key component of the
National COVID Cohort Collaborative, making important contributions in
addressing the unique challenges brought by COVID-19 to traditionally
underserved groups such as rural populations. Another supplement to the
WV CTSI supports a network for conducting COVID-19 testing in West
Virginia that includes the state health department, the national guard,
and rural clinics. This collaborative effort is playing a major role in
facilitating the state's testing efforts. Finally, the WV CTSI is also
a key participant of an NIH-sponsored multi-site Post-Acute Sequelae of
SARS-CoV-2 (PASC) study of ``Long COVID'' patients who continue to
experience symptoms long after initial infection.
Both NIGMS and NIH remain committed to supporting IDeA-CTR networks
like the WV CTSI, given the very important role that such networks play
in developing research infrastructure and improving health outcomes
within IDeA states.
The National Institutes of Health (NIH) believes that supporting
early career researchers is crucial to maintaining a productive,
innovative, and diverse biomedical research workforce that can continue
to advance the vitality of the scientific research enterprise. NIH's
Next Generation Researchers Initiative (NGRI) is developing and
implementing strategies to identify, support and retain investigators
across early career stages.
As part of the NGRI, NIGMS has prioritized and included several
strategies for supporting trainees and early-stage investigators (ESIs)
within its 2021-2025 Strategic Plan, along with targets for
implementing those strategies that provide accountability and the
ability to measure progress. Career development initiatives such as the
recently launched Maximizing Opportunities for Scientific and Academic
Independent Careers (MOSAIC) program focus on retaining and supporting
postdoctoral scholars from diverse backgrounds through the critical
point of transitioning them into independent faculty careers.
Cooperative agreements with professional organizations support
educational activities that equip MOSAIC scholars with professional
skills, mentoring, and career networks. At the individual level, grants
such as NIGMS' Maximizing Investigators' Research Award (MIRA) offer
support to early-stage investigators (ESIs) by providing them both the
opportunity to perform creative and ambitious research as well as the
flexibility to follow important new research directions and scientific
insights. Since launching this award mechanism in 2015, MIRA has
supported 628 early-stage investigators (ESIs), at least two of whom
were in West Virginia. In fiscal year 2020 alone, NIGMS funded 200 ESIs
through MIRA. As these examples illustrate, both the NIGMS and NIH
remain committed to supporting promising early career investigators in
every state in the nation.
______
Questions Submitted by Senator Roy Blunt
Question. Dr. Collins, I am a big supporter of the Clinical and
Translational Science Award (CTSA) program. I believe we should look
for ways to strengthen the CTSA program and reinforce the hubs around
the country. That is why I am troubled to hear about a possible CTSA
reorganization that will be announced in June. This reorganization
comes with limited discussion and consultation with the CTSA directors.
I am concerned, specifically, with the proposal to break up hub awards
into smaller pieces, requiring CTSAs to write several grant
applications instead of just one. Dr. Collins, I have two questions.
First, as you know, this Committee pays a lot of attention to CTSAs and
has been concerned in the past about communication between NCATS and
the CTSA community. For example, NCATS emailed relevant stakeholders to
combat the rumors about changes to the CTSAs, but did not provide any
relevant data to explain what they want to do and why they want to do
it. That did nothing but add to the concerns and speculation in the
community.
Why haven't these specific changes been discussed broadly within
the CTSA community? I believe if there was open dialogue and a stronger
partnership between NCATS and CTSAs, there would likely be more buy-in
from the community.
Two, how does cutting the hub award and requiring CTSAs to compete
for multiple awards strengthen the program? It appears to me that this
change would bring uncertainty to the program and jeopardize the
stability of the hubs.
Answer. The Clinical and Translational Sciences Award (CTSA)
program is indeed a very valuable and important program for the
National Center for Advancing Translational Sciences (NCATS), NIH, and
the nation. NCATS understands that there are often concerns when there
are planned updates to a program, particularly one as large and
impactful as the CTSA Program. The planned updates are part of the
regular NIH business process for reissuing Funding Opportunity
Announcements (FOAs), which is required because FOAs expire after 3-4
years. The planned updates will maintain the structure of the program
and reflect the public input received--much of which was provided by
the CTSA hub institutions and investigators. The planned updates are
designed to strengthen the program, by prioritizing hub strengths,
streamlining the overall application process, emphasizing clinical
partnerships which are critical to achieving the objectives of this
national program, and stabilizing the funding provided to the hub
institutions by allowing up to 7 years of funding (rather than the
typical five-year award period for NIH awards).
How NCATS Engages with the CTSA Community: NCATS agrees that a
strong partnership is extremely important and works closely with the
CTSA community on a regular basis.
--Regular Meetings: A CTSA Steering Committee \20\ including
leadership from NCATS and the CTSA Principal Investigator
community, meets monthly. A monthly webinar for all CTSA
Program investigators also shares information about the
program. NCATS CTSA leadership and program officers also
routinely engage with investigators and institutional
leadership across the CTSA Program as part of their regular
duties for implementing a program of this size and complexity.
In addition, there are yearly multi-day conferences where the
CTSA investigators and NCATS staff engage deeply on important
issues related to the CTSA program.
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\20\ clic-ctsa.org/groups/steering-committee.
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--Engaging the Community on Updates to the Planned FOA: To maintain
fair and open competition for funding opportunities, NCATS
cannot discuss specific details about a draft FOA with select
groups of the public, particularly those who already have
funding and would be re-competing for the funds. The level of
engagement must be framed to ensure that all investigators and
institutions, not only the current awardees, have an equal
opportunity to compete for the program funds and that NCATS
officials act impartially and not give preferential treatment
to any organization or individual.\21\ In following these NIH
policies, NCATS provided multiple opportunities to ask for and
receive input from the broader public, including the CTSA
community, on how to improve the CTSA Program.
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\21\ ethics.od.nih.gov/principles-ethical-conduct-government-
officers-and-employees.
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--A key approach for input was a Request for Information (RFI)
released in the Fall of 2019. The comments received, many
from the CTSA community, significantly influenced the
updates to the CTSA Program that NCATS is planning. (RFI;
NOT-TR-19-027 \22\)
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\22\ grants.nih.gov/grants/guide/notice-files/NOT-TR-19-027.html;
(see this video,www.youtube.
com/watch?v=LDBJSl-_QbQ, for an overview presentation of feedback
received).
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--General feedback was sought from CTSA application peer reviewers
over multiple study sections; many of whom are also CTSA
investigators.
--Informal discussions occurred with CTSA Program consortium
members, individually and in small group settings, over the
course of typical program oversight and interactions.
--Often the first public discussion about a future FOA occurs when
NCATS, like other NIH Institutes and Centers, seeks concept
approval from its Advisory Council during a session open to
the public. This occurs on June 11, 2021. Of note, the
NCATS Advisory Council includes three members that are
Principal Investigators from the CTSA Program.
--In addition, NCATS has built in additional time after the release
of the new FOA--6 months, instead of 2-4 months, prior to
the first application receipt date--to familiarize all
potential applicants with the new FOA, including hosting of
webinars to provide technical assistance to the applicant
community.
--NCATS widely shared a communication to address inaccuracies and
rumors about changes to the CTSA Program FOA. The letter
did not discuss planned changes to the CTSA Program nor
provide data, as sharing details about the FOA in a non-
public manner prior to its posting is not permissible.
--Summary of Stakeholder Feedback: From the input received through
the multiple approaches described above, stakeholder
feedback centered around four distinct areas: (1)
decreasing application administrative burden, (2)
increasing Hub flexibility and Hub specialization
opportunities, (3) expanding Hub funding options, and (4)
preserving partnerships and collaborations. Three
additional areas were identified by NCATS for improvement:
(1) ensuring the CTSA Program's sustainability (in terms of
avoiding the need to reduce the number of hubs or cut
budgets), which requires updates to budget formulas and
calculations; (2) increased emphasis towards addressing
health disparities; and (3) strengthening clinical research
capabilities, which have been critical to the national
responses to the opioid epidemic and the coronavirus
disease 2019 (COVID-19) pandemic.
Hub Budgeting: NCATS takes the proper stewardship of taxpayer funds
very seriously. NCATS does not intend to change the number of hubs or
the amount of funding dedicated to the hub core awards. Future award
amounts will be based on the amount requested by each applicant and
will follow a revised formula for classifying the size of awards from
what is currently used. In addition to incorporating feedback from
different stakeholders, one of NCATS' objectives is to ensure the long-
term sustainability of the program while avoiding a reduction in the
number of hubs or reducing hub budgets to stay within the appropriated
budget for the program. Requested budgets for CTSA awardees have been
increasing to the highest award size under the CTSA graduated award
structure, which is not sustainable under current funding for the
program, so a restructured award calculation is needed. The total award
size of future hubs is anticipated to be similar to the current awards
for the vast majority of awardees.
Structure of the Program Applications: NCATS considered extensive
public feedback, outlined above, in updating the CTSA Program FOA,
including how these updates could contribute to stabilization for the
awardees and to sustainability of the program. To date, the application
process for institutions applying for CTSA hub awards has been
complicated and burdensome, linking up to three separate activities
together into one package, the U54 application. Linking the Hub, Career
Development, and Training activities together for application
submission and peer review is primarily for the benefit of NIH in being
able to track these activities. However, based on feedback, it places
substantial burden on the applying institution in the form of
developing large, complex applications, often containing several areas
of duplicate information. The review of three separate activities in
one application risks pulling an institution out of funding range, due
to one of the activities not faring well in peer review. Applicants
that do not successfully compete face a prolonged period of uncertainty
for funding, while having to address, revise, and resubmit the entire
U54 application package for a subsequent review cycle. These factors
combined with the duration of the awards--five years --raises the
stakes of each application and contributes to an environment where
applying and awarded institutions are in a constant state of
application preparation.
Stakeholder concerns about the complexity of the current
application are an important and consistent piece of feedback NCATS
received. Separating the applications will streamline the submission
process for each component, will reduce duplication of information in
an application, will result in less reliance on the success of one part
of the application, will avoid the risk of significant delays in
awarding a hub if the Training or Career Development components are not
strong, and may allow better alignment of Training and Career
Development awards with the clinical training calendar. Separating the
Hub application from the training and career development applications
will also allow the Hub application, which is the key institutional
award, to be awarded for up to 7 years, more than the standard 5 years.
With this strategy, NCATS intends to provide further stability to an
institution's funding by extending the Hub award. Combining all
applications together does not allow for that seven-year Hub award
option, as NIH limits training and career development awards to 5
years. Separating the applications and providing the additional planned
funding opportunities will also give the institutions more control over
where they place their priorities based on their own strengths, another
key piece of feedback received through stakeholder input.
In closing, we hope that these responses have addressed your
concerns. If not, NCATS is happy to provide additional information.
NCATS recognizes the significance of the CTSA Program. The pandemic has
further served to highlight the importance of this program in
responding to emerging clinical and translational needs at local,
regional, and national levels. NCATS' intent with the proposed updates
to the CTSA FOA is to strengthen the program, provide additional
funding stability, and continue to incorporate research to tackle
health disparities through this program. NCATS also wants to address
important concerns raised by the CTSA community to streamline
application and award preparation processes, continue to emphasize the
importance of partnerships, and allow institutions more flexibility to
leverage their strengths in contributing to this important national
resource.
Question. Dr. Collins, the impact of COVID-19 has been
significant--both to Americans physical health, but also to their
mental health. The fiscal year 2022 budget includes $25 million for
focused research on the impact of the pandemic on mental health.
Can you discuss what research areas this funding will be focused on
and how the All of Us research initiative will play a role in
understanding the full impact of the pandemic?
Answer. The All of Us Research Program's participants come from
diverse communities across the United States and generously donate
their data and time to drive a wide range of biomedical discoveries,
which are vital for informing public health strategies and
preparedness. Due to the diverse nature of the program, the All of Us
Research Program will play a vital role in understanding the mental and
physical impact of the pandemic across the United States and within
some of the hardest-hit communities. All of Us began to address the
challenge of the coronavirus disease 2019 (COVID-19) pandemic in May
2020 by leveraging its significant and diverse participant base to seek
new insights into COVID-19 and its impact through an online COVID-19
Participant Experience (COPE) survey.\23,24\ The COPE surveys focused
on understanding the mental and physical impacts of the COVID-19
pandemic on participants and included questions on symptoms, stress,
social distancing, social determinants of health, and economic impacts.
Participants were invited to take the survey in May, June, July,
November, and December 2020, and February 2021. This multi-pronged
assessment will enable researchers to study the effects of COVID-19
over time and better understand how COVID-19 affects people's mental
and physical health differently. To date, over 10,000 participants
completed all six COPE surveys and over 100,000 completed at least one
COPE survey during the pandemic, with 70 percent of those participants
coming from a community that is historically underrepresented in
biomedical research.
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\23\ allofus.nih.gov/news-events-and-media/announcements/all-us-
research-program-launches-covid-19-research- initiatives.
\24\ www.nlm.nih.gov/dr2/
COPE_Survey_NIH_All_of_Us_Clean_4.27.20.pdf.
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In addition to COPE, All of Us tested blood samples from over
24,000 participants collected between January 2 and March 18, 2020, for
the presence of SARS-CoV-2 antibodies, which provided evidence of
infection in five states prior to initial reports. The program
anticipates making the full results of this study available in June
2021.\25\ Additionally, All of Us is collecting relevant electronic
health record (EHR) information from more than 246,000 participants,
some of whom have been diagnosed with COVID-19 or sought healthcare for
related symptoms, to help researchers look for patterns and learn more
about the physical and mental health impacts of COVID-19 and the
effects of different medicines and treatment. As data are made
available from all of these efforts, researchers will look for new
leads that may bring greater precision to the diagnosis, treatment, and
prevention of COVID-19, including those communities that have been hit
the hardest. The program will make data gathered through these
activities broadly accessible to approved researchers on a rolling
basis, in future releases of its secure data platform, the Researcher
Workbench.\26\ The program will continue to explore additional ways it
can leverage its unique and diverse dataset to answer critical research
questions to enhance our understanding about the full impact of the
pandemic, especially with a focus on mental health.
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\25\ The results of this study were announced on June 15, 2021;
complete details at: allofus.nih.gov/news-events-and-media/
announcements/nih-study-offers-new-evidence-early-sars-cov-2-
infections-us.
\26\ www.researchallofus.org/.
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Question. Dr. Collins, the COVID-19 pandemic highlighted the need
to use non-human primates (NSP) in research. The budget requests $30
million for NSP infrastructure.
Can you provide further details to the Committee on the need for
this funding and details on how this funding would be allocated and to
whom?
What types of research would be at jeopardy if NSPs were not
replaced or expanded?
Answer. The National Institutes of Health (NIH) remains committed
to protecting animal welfare while, at the same time, advancing
biomedical research and human health. The budget request for $30
million for nonhuman primate infrastructure would cover facilities used
to house nonhuman primates which require continual updates and
maintenance to ensure responsible stewardship over these invaluable
resources. The funds in the budget request would be distributed by
soliciting applications from NIH grantees to improve existing
facilities, not to establish new nonhuman primate facilities. Several
nonhuman primate facilities have existed for over 60 years and housing
enclosures require frequent repair and replacement. New construction
for research facilities would include animal holding rooms, necessary
equipment such as surgical tables, centrifuge, ultrasound, clinical
analyzer, procedure, and veterinary clinical support in order to meet
or exceed the current high-level care of the nonhuman primates.
Additionally, the COVID-19 pandemic highlighted the need for new
construction to expand animal biosafety level 3 areas in order to have
biocontainment facilities associated with nonhuman primate facilities.
In addition to ethically appropriate housing, nonhuman primates require
a proper diet, clinical/veterinary care as well as psychological and
environmental enrichment, which necessitates skilled staff and
additional resources including supplemental produce, various enrichment
devices such as foraging devices for food, various toys, and puzzles.
NIH would support expansion at existing NIH-supported facilities to
leverage the investment. The NIH Office of Research Infrastructure and
Programs (ORIP) supports a well-coordinated national consortium of
seven National Primate Research Centers (NPRCs) and other breeding
colonies that collectively address research needs and trends, best
husbandry practices, maintenance of genetic diversity, standardization
of models, ethics, rigor, and reproducibility. NPRCs are national
resources serving not only NIH-funded investigators but other federally
funded investigators, foundations, and industry, including many SARS-
CoV-2 projects in the last year.
Research with animal species, including nonhuman primates, remains
critical for modeling human physiology and is essential for developing
new prevention strategies, treatments, and cures for disease beyond the
need for responding to emerging infectious diseases. Nonhuman primates
have been essential for understanding human biology and developing
treatments for diseases, mostly because of our shared anatomy,
physiology, and behavior. Importantly, the genetic sequence
similarities between nonhuman primates and humans can reach up to 98.77
percent, which has made nonhuman primates models critical for studying
neurobiology, transplant tolerance and rejection, infectious diseases,
reproductive biology, and regenerative medicine. More recent
applications have been in regenerative medicine and gene therapy and
editing. There is a rapidly emerging need for marmosets in the
neurosciences where recent National Academies of Sciences, Engineering,
and Medicine (NASEM) reports and the Brain Research Through Advancing
Innovative Neurotechnologies (BRAIN) Initiative community have pointed
out that demand far exceeds supply.\27\ Another critical area of
intense need and research development is nonhuman primate models of
Alzheimer's disease to develop therapies. Nonhuman primate models are
commonly used for studies of visual systems, auditory systems,
cognitive function, and brain connectivity. The single largest
application of nonhuman primates continues to be in developing vaccines
and therapies for HIV/AIDS.
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\27\ www.nap.edu/read/25356/chapter/7.
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Research using animal models, including nonhuman primate models,
has led to tremendous advances critical for saving countless lives and
extending human life expectancy around the world. Until suitable non-
animal models are developed, the complexity of human systems, both in
health and in disease, can only be truly understood through
complementary model systems with sufficient complexity, and nonhuman
primates remain invaluable for this effort. When animal models are
required, NIH will only conduct and support research in accordance with
the highest scientific and ethical principles. To uphold these
principles, the NIH budget includes investments in nonhuman primate
facilities, resources, and enrichment.
Question. Dr. Collins, how much funding, broken down by Institute
or Center, has NIH repurposed for COVID-19 related lab reopenings or
lost research activities?
Answer. To support our recipients affected by the pandemic, the
National Institutes of Health (NIH) provided extensions, both funded
and unfunded, as well as administrative supplements, to address the
unanticipated impacts of the pandemic. The NIH has also issued multiple
funding opportunities for current recipients to repurpose existing
awards and expand the scope of ongoing research to include coronavirus
disease 2019 (COVID-19) research activities.\28\ Continued support for
these projects is contingent on satisfactory progress, the availability
of funds, and NIH Institute and Center (IC) funding priorities, which
continue to change as the pandemic, and research on COVID-19
progresses.
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\28\ grants.nih.gov/grants/guide/COVID-Related.cfm.
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Decisions related to individual awards are made by the funding NIH
IC on a case-by-case basis, taking into account those critical factors.
All requests to change the scope of an NIH grant award require prior
approval from the awarding NIH IC, as stipulated in the NIH Grants
Policy Statement, section 8.1.2.5.\29\
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\29\ grants.nih.gov/grants/policy/nihgps/HTML5/section_8/
8.1.2_prior_approval_
requirements.htm#Change4.
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The NIH continues to analyze the data on the impact of COVID-19 on
the biomedical research community, and its potential impact on NIH
budget and grant activities.
Question. It is my understanding that one of the main issues NIH
faced related to COVID-19 expenses was for post-doctoral candidates
finishing their training, research, or fellowship.
How has this issue been addressed and do you expect to see a
funding issue related to the extension of some of these grant awards
into fiscal year 2022?
Answer. The coronavirus disease 2019 (COVID-19) pandemic, along
with extensive mitigation measures, has adversely affected progress in
many biomedical research settings. Evidence from multiple sources,
including results from a survey during the fall of 2020, indicates
legitimate concerns about career trajectory for early career
scientists.\30\ Hearing these concerns, the National Institutes of
Health (NIH) issued a Guide Notice detailing our approach to support
early career scientists whose career trajectories may have been
significantly affected by the pandemic.\31\ Specifically, NIH is
providing an opportunity for recipients in their last year of NIH
Fellowship (F) and NIH Career Development (K) awards who have been
impacted by COVID-19 to request extensions.\32\ Such extensions will be
considered on a case-by-case basis, within the existing availability of
funds.
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\30\ nexus.od.nih.gov/all/2021/03/25/the-impact-of-the-covid-19-
pandemic-on-the-extramural-scientific-workforce-outcomes-from-an-nih-
led-survey/.
\31\ grants.nih.gov/grants/guide/notice-files/NOT-OD-21-052.html.
\32\ https://nexus.od.nih.gov/all/2021/02/08/extensions-for-early-
career-scientists-whose-career-trajectories-have-been-significantly-
impacted-by-covid-19/.
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Generally speaking, the NIH typically makes between 500 to 600 F
and K extensions per year, the vast majority (more than 95 percent) of
which are no-cost extensions. Only seven funded extensions were awarded
in fiscal year 2019. In fiscal year 2020, the NIH awarded 548
extensions, with 75 (14 percent) of these being funded extensions. Thus
far in fiscal year 2021, 15 funded extensions are linked to NOT-OD-21-
052, but we will have a much better sense of uptake as the fiscal year
concludes. Though there appears to be a relative increase in the number
of funded extensions commensurate with the pandemic, the absolute
numbers remain low.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. What is the fully intended scope of ARPA-H? Will it
address diseases beyond cancer, diabetes, and Alzheimer's, such as ones
with more challenging markets? Do you have examples?
Answer. The scope of the Advanced Research Projects Agency for
Health (ARPA-H) is intended to be broad and, indeed, stretch beyond the
areas initially identified by the President. There are a number of
areas with substantial unmet needs--some examples include emerging
infectious disease, rare and ultra-rare disease, and antimicrobial
resistance--and, with targeted investments over time, breakthrough
progress could be made. In addition to specific disease areas, ARPA-H
intends to build capabilities and explore various platform
technological approaches which may have broad applicability across a
range of diseases and conditions. A recent commentary in Science \33\
outlined some exciting concepts such as developing mRNA vaccines to
prevent most cancers; creating molecular ``zip codes'' to more
precisely target tissues and cell types while minimizing side effects;
deploying holistic interventions that identify those at high-risk and
leverage new telehealth approaches to eliminate racial disparities in
maternal morbidity and mortality rates and premature births; and
developing small, highly accurate, inexpensive, non-intrusive, wearable
24/7 monitors for blood pressure and blood sugar. While these examples
are meant to illustrate the breadth of potential projects that ARPA-H
could support, we believe it is projects like these that can have a
significant impact for patients who are relying on biomedical research
and innovation to live longer, healthier lives.
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\33\ science.sciencemag.org/content/373/6551/165.
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Question. Additionally, how will ARPA-H fit into the larger health
focused R&D structure? How will its role be defined as unique among the
various funding programs, and will there be coordination with other
entities such as BARDA to ensure cooperation and avoid duplication?
Answer. The Advanced Research Projects Agency for Health (ARPA-H)
is meant to become an integral component of the constellation of
agencies focused on promoting health and research and development--both
within and beyond NIH and HHS. As described in a recently published
commentary in Science,\34\ ARPA-H should be housed as a new entity
within NIH. The rationale for this organizing principle is two-fold.
First, the goals of ARPA-H fall squarely within the mission of the NIH,
which is ``to seek fundamental knowledge about the nature and behavior
of living systems and the application of that knowledge to enhance
health, lengthen life, and reduce illness and disability.'' Second, the
NIH offers a rich source of fundamental health research that will be
foundational for a constructive, collaborative, and productive
relationship with ARPA-H. We envision robust collaborations on
synergistic topics with the existing NIH Institutes and Centers, along
with organizations both outside and within the government. The added
benefit of housing ARPA-H within NIH is that it will create
administrative efficiencies so that more resources can be directed
toward the mission and help avert duplication of effort.
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\34\ science.sciencemag.org/content/373/6551/165.
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In mid-July, the Administration launched a Federal Joint Fast Track
Action Committee (FTAC) intended to help steer the creation of ARPA-H
and lay the groundwork for strong interagency coordination. OSTP and
NIH serve as co-chairs of this committee that includes representatives
from the Department of Agriculture, DARPA, Office of the Under
Secretary of Defense for Research & Engineering, ARPA-E, BARDA, CDC,
CMS, FDA, VA, EPA, NSF, and the Smithsonian Institution, among others.
Bringing these entities together at an early stage will help ensure
strong collaboration and coordination among the various research-
focused organizations throughout the Federal Government. The agency
personnel who sit on the FTAC will also be a valuable source of insight
and advice as ARPA-H is launched.
______
Questions Submitted by Senator Patrick J. Leahy
Question. I strongly support the Administration's renewed approach
to innovation in medical research through the establishment of the
Advanced Research Projects Agency for Health (ARPA-H). COVID-19 has
shown that a commitment to breakthrough innovation, directed allocation
of resources, and collaborative approaches can accelerate how
scientific breakthroughs can be transitioned to treatments and cures.
The administration has proposed that the agency will focus on
innovative treatments in cancer, Alzheimer's disease, and opioid
disorders. Several institutions in Vermont are national leaders in
these stated research fields despite their smaller and more rural
nature. While I strongly support any efforts to accelerate innovation,
I am concerned that valuable collaborators could be left out or lose
out on Federal funding, particularly if there is no traditional grant
application process.
What role will smaller and more rural research institutes play in
ARPA-H? If projects are funded outside a grant application process,
will there be established guidelines to include collaborators from
rural or traditionally underrepresented areas?
Answer. Over the long term, the proposed structure for the Advanced
Research Projects Agency for Health (ARPA-H) is intended to empower the
ARPA-H leadership and staff to set and execute on research priorities
for a variety of high-risk, high-reward, milestone-driven projects that
can lead to novel capabilities, platforms, and resources that are
applicable to a range of diseases. These priorities include the
opportunity to fund smaller and more rural research institutes.
For the initial direction, the Administration is working to set up
multiple pathways, both within the government and the broader
stakeholder community, for priority setting and for exploring new areas
ripe for research at ARPA-H. At the time of this hearing, the White
House Office of Science and Technology Policy (OSTP) and the National
Institutes of Health (NIH) are in the planning phases of convening
multiple listening sessions with key stakeholder groups including
patient organizations, industry, venture capitalists and
philanthropists, and others from the academic and research communities.
During these sessions, stakeholders will be asked to offer their
perspective on what they see as the greatest research challenges and
opportunities that could be addressed using the ARPA-H model. This
input will help refine the scope and provide a wealth of ideas for the
first ARPA-H director to consider as they develop the agency's vision.
In mid-July, the Administration established a Joint Fast Track
Action Committee (FTAC) to help steer the creation of ARPA-H and lay
the groundwork for strong interagency coordination. OSTP and NIH serve
as co-chairs of this committee that includes representatives from
Department of Agriculture, DARPA, Office of the Under Secretary of
Defense for Research & Engineering, ARPA-E, BARDA, CDC, CMS, FDA, VA,
EPA, NSF, and the Smithsonian Institution, among others.
Soliciting a diversity of perspectives and approaches will be a key
tenet of the Advanced Research Projects Agency for Health (ARPA-H).
Much like DARPA and ARPA-E, it will do so by supporting the best
strategies to solve an identified challenge and by pursuing multiple
approaches. Program managers will also have the authority to combine
proposals from different institutions to assemble the boldest, most
innovative portfolio, allowing each team to build on their strengths
while benefiting from the knowledge, expertise, and resources from
other institutions. ARPA-H will also provide awards that range in size
and mechanism--from smaller, pilot projects to develop a prototype, to
complex multi-site trials, to prizes that stimulate healthy competition
and ingenuity. Further, ARPA-H will support a Small Business Innovation
Research (SBIR) and Small Business Technology Transfer (STTR) program
with business development, commercialization, and other resources to
provide small businesses with the tools they need to be successful.
These approaches are examples of mechanisms that ARPA-H will utilize to
support a range of organizations across the country which may include
small and/or rural institutions, and its portfolio will be regularly
evaluated to ensure there is diversity of perspective. Because ARPA-H
will be a nimble, dynamic organization, it will be able to readily
pivot to experiment with new approaches.
Question. Chronic pain is a significant public health issue
affecting an estimated 50.2 million Americans each year. Based on data
from the National Health Interview Survey (NHIS), the total value of
lost productivity due to chronic pain is estimated to be nearly $300
billion annually. With little known about alternatives for treating and
managing relief from pain, medical providers are often limited to
prescribing highly addictive opioids or muscle relaxants to help
patients mitigate symptoms from pain. Scientific research suggests that
long term use of such medications can result in the body's reduction of
its own ability to fight pain. Even for patients who do not experience
direct abuse or addiction with long term use, scientists have found
that withdrawal symptoms are present when patients stop taking these
medications. Unfortunately, research into addiction and alternatives to
treatment has historically lagged at NIH. Enhanced research on chronic
pain management and treatment, other than through the use of highly
addictive opioid painkillers, has the potential to reduce substance
abuse and promote better methods for addressing pain.
I strongly support the NIH Heal Initiative to find solutions to
curb the national opioid public health crisis by understanding,
managing, and treating pain. Please describe any progress made by the
HEAL Initiative on medication development to alleviate pain and to
treat addiction. What remains the biggest barrier to research to
investigate new and alternative options to treat chronic pain?
Answer. The National Institutes of Health (NIH) recognizes the need
to improve pain management without risk of addiction and other serious
side effects. NIH is taking a multi-pronged approach to develop safe
and effective therapies to reduce our reliance on opioids and treat
addiction. The NIH Helping to End Addiction Long-term (HEAL) Initiative
launched in 2018 has awarded over $1.5 billion for research to discover
and accelerate development of non-addictive pharmacological and non-
pharmacological pain treatments, as well as treatments for opioid use
disorder (OUD) and overdose.
Through the HEAL Initiative, NIH supports over 70 targeted studies
to accelerate the development of treatments for OUD, including novel
medications and biologic agents, as well as novel formulations of
approved medications to treat OUD and prevent opioid overdose. To date,
16 Investigational New Drug Applications were filed with the U.S. Food
and Drug Administration and authorized to proceed for human studies.
These studies focus on a variety of drug targets, as well as vaccines
that could prevent opioids from entering the brain. HEAL currently
funds nine opioid vaccine projects including vaccine candidates
targeting oxycodone,\35\ fentanyl \36\ and heroin.\37\ This strategy
could offer more accessible, manageable treatment through longer-
lasting vaccines to reduce the risk of relapse.
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\35\ reporter.nih.gov/search/Pcd2IghkPU6lnJkOT7FlFQ/project-
details/9778811.
\36\ reporter.nih.gov/search/Wp_sHzUhIUuYqDimSa90iw/project-
details/9737173.
\37\ reporter.nih.gov/search/GNnJWbYvQUeIlbwhgFofXA/project-
details/9734921.
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HEAL-supported work also includes studies to identify, optimize and
test promising molecules, biologics, and devices for treating pain that
target non-opioid pathways in the nervous system. Biomarker studies to
enhance clinical trials and improve best practices are moving forward.
In addition, non-pharmacological approaches to manage many different
pain conditions are being evaluated through effectiveness and
implementation research approaches.
In these ways, HEAL is providing much needed resources to advance
research on new and safe alternatives to opioids for chronic pain. The
complexity and diverse nature of chronic pain itself along with a high
prevalence of other co-occurring chronic conditions such as diabetes,
depression, and autoimmune disorders create an enormous challenge for
advancing research.
Mechanisms for the causes of different pain conditions vary,
biomarkers for patient response to treatment and likelihood for
progression of disease also are characteristic of the disease
condition. In addition, treatments for co-morbidities require careful
balancing and often long- term multidisciplinary care. These and other
factors require an expanded breadth and scope of pain research to
better provide personalized care for those with chronic pain. The
Federal Pain Research Strategy \38\ describes research priorities to
relieve the burden of pain. The NIH HEAL initiative provided support to
move many of the report's recommendations forward.
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\38\ www.iprcc.nih.gov/federal-pain-research-strategy-overview.
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Specifically, the NIH HEAL initiative established essential pain
research infrastructure to accelerate development of new medications
and devices to treat pain. An analgesic screening platform uses animal
and human cell-based models such as neural tissue chips for rapid
screening of molecules or devices for analgesic-relevant biological and
pain behavioral activity. HEAL, with input from academic and industry
partners, established an Early Phase Pain Investigation Clinical
research network (phase 2 studies) to test safety and efficacy of novel
therapeutics and a later stage pain management Effectiveness Research
Network (ERN) to compare effectiveness of pharmacological and non-
pharmacological approaches in many different pain conditions. The
Pragmatic and Implementation Studies for the Management of Pain to
Reduce Opioid Prescribing (PRISM) network focuses on clinical trials of
non- pharmacologic pain therapies in healthcare systems. The Phase 2
network will launch trials on two new analgesics in late 2021. The ERN
is supporting eight large trials for various pain management
strategies. PRISM is supporting six large trials in healthcare systems.
In addition, HEAL established an analgesic development pipeline to
accelerate the development and testing of novel drugs and devices. This
comprehensive program uses team-based science coupled with a
comprehensive set of research resources to bring new therapeutics
rapidly to the clinic. To advance the discovery and validation of new
drug targets, HEAL has funded over 30 projects to discover and verify a
diverse set of drug target types across multiple pain conditions, six
drug optimization studies on new safe and effective pain treatments,
and 11 projects to test the effectiveness of implanted devices and
noninvasive stimulation of nerves in the brain or throughout the body
to reduce perception of pain. In addition, to improve the efficacy of
clinical trials for pain treatments, and to increase the chance that
new therapeutics will advance along the regulatory path to approval,
HEAL tests the development of biomarkers to objectively measure pain,
including pain associated with sickle cell disease, musculoskeletal
disease, nerve pain and headache. Promising biomarkers identified
through this program may advance to clinical validation through the
Early Phase Pain Investigation Clinical Network (EPPIC-Net). Findings
from these studies could improve quality of life for millions of people
in the United States who experience pain daily. Recent HEAL
accomplishments toward new therapeutics include two patent filings for
small molecule modulators of pain receptors involved in chronic pain
and migraine.
New directions for HEAL will also continue to pursue goals laid out
in the Federal Pain Research Strategy,\39\ including demonstration
projects to aid in the development of a coordinated approach to pain
management in healthcare systems. This effort would assess multi-
disciplinary and multimodal approaches to pain management embedded in
healthcare systems. Research within systems of pain care would allow
for effective interventions to be adopted into the healthcare system
and improve access for patients. Focused discussion with select
healthcare program leadership would identify pain conditions of
greatest opportunity, with an emphasis on effectiveness research,
quality management and team-based care. This effort would seek to
leverage existing infrastructure through ongoing collaborative and
interagency efforts.
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\39\ www.iprcc.nih.gov/federal-pain-research-strategy-overview.
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Another specific effort in development aims to advance health
equity to address the wide disparities in care and treatment for pain
and addiction, known to result in both the undertreatment and
overtreatment with opioids, increased risk of addiction and overdose,
lack of access to effective non-pharmacological options for pain
treatment, and lack of access to evidence-based addiction care.
Disparities in pain management exist across multiple levels: pain
assessment, treatment, and management at the patient, provider,
community, and healthcare system levels. Planned expansion to HEAL
includes the development and implementation of culturally appropriate
interventions for the prevention and management of pain and addiction
in diverse populations, with a focus on sustainable and scalable
interventions that can be rapidly implemented by healthcare systems.
In addition, recent discoveries in human genetics and molecular
biology will be incorporated into the development of a novel team-based
platform to rapidly test targets and candidate therapeutics for diverse
human pain conditions and share findings with the wider pain research
community. This research will address pain systems and allow for a
variety of research questions including conditions of chronic analgesic
use, other drug use, substance use disorders (SUDs) and other co-morbid
conditions, and will enable and accelerate human gene- and cell- based
validation of pain therapeutic targets through the HEAL initiative and
other pipelines. This will build on existing HEAL research on
preclinical and translational research in pain, and ongoing efforts to
accelerate the development of novel treatments for pain. Through these
and other efforts at HEAL and across the NIH, we aim to continue to
improve our understanding of pain and develop non-addictive, effective
therapies.
Question. Migraine is currently the second leading cause of all
global disability. Unfortunately, due in part to limited research and
treatment, inappropriate opioid prescriptions for migraine present
Americans with ongoing risks of opioid use disorders and have worsened
outcomes in patients. Overall, 6 million Americans living with
migraines are active opioid users. I strongly support the NIH Heal
Initiative to find solutions to curb the national opioid public health
crisis by understanding, managing, and treating pain. While migraine
grant proposals are eligible for consideration under the HEAL request
for applications (RFAs) issued for pain research, less than 1 percent
of HEAL Initiative appropriations have funded headache disorders
research--the least funded NIH area among all the nation's burdensome
diseases. I am very concerned about the failure to attract enough
investigators to this historically under-funded research area.
Does NIH have plans to issue specific RFA programs for headache
disorders research, comparable in scope to the Back Pain Consortium
(BACPAC) group of RFAs for research on back pain?
Answer. The National Institutes of Health (NIH) recognizes the
burden of pain at the individual and population levels and that
headache disorders are prevalent and disabling conditions which affect
millions of Americans. The NIH launched the HEAL Initiative (Helping to
End Addiction Long-term) to improve pain care and better prevent and
treat opioid use disorder. Priorities of the HEAL initiative, developed
with our stakeholders with expertise in pain research and care, include
enhanced understanding of pain, discovery and validation of novel pain
therapeutic targets, testing therapies in clinical settings, and
accelerating the process to bring new therapies to patients. The
initiatives are, or were, open to all pain conditions. The HEAL
initiative also established much needed research infrastructure to
support innovative science. Headache research fits within the scope of
all these initiatives and will benefit from the enhanced
infrastructure.
HEAL funding solicitations call for proposals across all pain
conditions. NIH staff recognizes the low submission rate of headache
applications and broadly disseminates information on HEAL and other
funding announcements to the research community to encourage
submissions. Most funding announcements specifically cite headache as
an area of interest and others are inclusive of headache. Low back pain
is an exception among pain conditions in that it has unique research
gaps such as lack of diagnostic tools and technologies, no accepted
common data elements, poor diagnostic criteria, complex etiology, and
lack of an adequate evidence base for effective practice guidelines.
The HEAL Back Pain Consortium (BACPAC) initiative was launched to fill
these extensive gaps to improve pain care across the spectrum of low
back pain.
Migraine and other headache disorders have good classification
schemas, a range of effective treatment therapies whose development was
supported by NIH research, and evidence-based diagnostic categories and
treatment protocols (International Headache Society). Our understanding
of migraine etiology is more advanced than that for back pain. NIH has
supported transformative basic research that advanced our knowledge of
migraine mechanisms, causes, and predictors, biomarker identification,
and new therapy development. For example, NIH supported investigators
provided the foundation for development of CGRP antibodies now used
widely for migraine therapy. NIH sponsored research also contributed to
understanding how migraine auras activate nociceptors and initiate a
migraine, and the mechanism of action for new migraine therapies such
as vagus nerve stimulation. Basic research on potassium channels,
delta, or kappa opioid receptors, and TRP channels fundamentally
increased our understanding of trigeminal nociceptors and their
involvement in initiating a migraine, giving us new targets for
potential treatments. An NIH sponsored pivotal pediatric migraine
clinical trial changed clinical practice for children with chronic
daily headaches.
NIH and HEAL leadership recognize that far too many headache
sufferers are prescribed opioids despite clear clinical practice
guidelines that call for non-opioid effective alternatives rather than
opioids. This practice reflects the sparsity of headache specialists
and the lack of and education of our primary care providers who are
often the first to treat those with disabling migraines. NIH also
recognizes the need to expand the headache research workforce. The HEAL
initiative recently released funding announcements to support training
and mentorship of early and mid- career researchers in the field of
basic, translational, and clinical pain research. We encourage those
interested in headache research to benefit from these opportunities.
______
Questions Submitted to Dr. Anthony Fauci
Questions Submitted by Senator Richard J. Durbin
Question. I have received a lot of questions from Illinois
families, who are hoping for more clarity on the CDC's most recent mask
guidelines. Many vaccinated parents--with unvaccinated children at
home--are wondering if they should be wearing masks when out in public.
What advice would you give to vaccinated parents who have
unvaccinated children at home?
When do you think we will have a COVID vaccine approved for
children younger than 12 years of age?
Answer. Currently authorized coronavirus disease 2019 (COVID-19)
vaccines meet the U.S. Food and Drug Administration's (FDA's) rigorous
standards for safety and effectiveness, and current data suggest that
fully vaccinated people are less likely to transmit severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) to others. According to
the Centers for Disease Control and Prevention (CDC), fully vaccinated
people--including those living with unvaccinated children or
adolescents--can resume activities without wearing masks or physically
distancing, except where required by Federal, state, local, tribal, or
territorial laws, rules, and regulations. Individuals ages 2 and older
who are unvaccinated, however, should continue to wear masks in public
and when around people who do not live in their household, except when
eating or sleeping. CDC will continue to evaluate and update public
health recommendations for fully vaccinated people as more information,
including on Delta and other new variants, becomes available.
Efforts to evaluate COVID-19 vaccines in children under age 12
currently are underway, and a COVID-19 vaccine may be available for
this age group by the end of 2021. On March 16, 2021, Moderna, in
collaboration with the National Institute of Allergy and Infectious
Diseases (NIAID) and the Biomedical Advanced Research and Development
Authority (BARDA), launched KidCOVE, a Phase 2/3 study to evaluate the
safety and efficacy of the Moderna COVID-19 vaccine in children ages 6
months to less than 12 years. Pfizer also is conducting a Phase 1/2/3
trial to evaluate its COVID-19 vaccine in this age group. In addition,
other vaccine developers are planning to begin trials to test their
vaccine candidates in children. Until a COVID-19 vaccine is available
for children under age 12, it will be important for all individuals,
especially children and other unvaccinated individuals, to continue to
follow all public health measures for COVID-19 advised by the CDC,
including frequent hand washing and the use of masks and social
distancing in certain settings.
______
Questions Submitted by Senator Joe Manchin, III
Question. My home state of West Virginia is battling an epidemic
during the middle of a pandemic. My state has been devastated by the
drug epidemic, COVID-19, and we now lead the nation in new HIV
infection rates. You have spent much of your career focused on the
prevention, diagnosis, and treatment of HIV/AIDS. Your research has
been instrumental in saving countless lives in the United States and
around the world. The National Institute of Allergy and Infectious
Diseases supports initiatives focused on diagnosing, treating,
preventing and responding to the HIV epidemic in the United States.
These efforts represent steps in the right direction, but will not
alone end West Virginia's increasing numbers of new HIV infections and
other opioid-related infectious diseases.
What is being done to replicate testing and surveillance efforts we
saw put into place for COVID-19 for other infectious diseases, like
HIV/AIDS?
What public health infrastructure would be required to bring better
infectious disease testing and surveillance to fruition?
Answer. The Federal response to coronavirus disease 2019 (COVID-19)
relied heavily on the utilization and expansion of existing resources
for human immunodeficiency virus (HIV) and other infectious diseases.
By leveraging available resources, we have been able to accelerate the
development of diagnostic tests and other medical countermeasures, as
well as surveillance and community engagement efforts. In turn,
knowledge gained from the COVID-19 response may inform strategies to
address other infectious diseases such as HIV. This includes efforts
undertaken by the U.S. Department of Health and Human Services (HHS) to
end HIV in the United States by 2030 through the Ending the HIV
Epidemic in the U.S. (EHE) initiative. EHE is coordinating across HHS
agencies and with patient, community, academic, and other partners to
plan, design, and deliver local HIV prevention and care services. This
``whole-of-society'' approach is a model for ending both the HIV
epidemic as well as the COVID-19 pandemic. Proper diagnosis and
treatment of HIV are key components of this initiative, and efforts to
improve testing and surveillance for HIV are ongoing.
An important aspect of the response to the COVID-19 pandemic as
well as the HIV epidemic is community engagement. The National
Institute of Allergy and Infectious Diseases (NIAID), in cooperation
with the Department of Defense, established the COVID-19 Prevention
Network (CoVPN) by leveraging existing NIAID-funded clinical trials
networks, including networks focused on HIV treatment and prevention.
The CoVPN built on existing community relationships to enhance trust
and meaningful engagement in key racial and ethnic minority communities
throughout the United States to promote diverse participation in
clinical trials for COVID-19. The community relationships enhanced by
the CoVPN may be further leveraged to advance efforts, including
testing and surveillance, for HIV and other infectious diseases.
The National Institutes of Health (NIH) also anticipates that the
rapid establishment of COVID-19 testing and surveillance may help to
address HIV and other infectious diseases. NIH launched the Rapid
Acceleration of Diagnostics (RADx) initiative to speed innovation in
technologies to test for severe acute respiratory syndrome coronavirus
2 (SARS-CoV-2), in partnership with the Biomedical Advanced Research
and Development Agency (BARDA), the Centers for Disease Control and
Prevention (CDC), the U.S. Food and Drug Administration (FDA), and the
Defense Advanced Research Projects Agency (DARPA). As part of RADx, NIH
and CDC are evaluating whether frequent self-administered, at-home
SARS-CoV-2 testing helps reduce community transmission of SARS-CoV-2.
Efforts to develop and deploy rapid, point-of- need diagnostics for
SARS-CoV-2--including at-home testing kits--may inform community-based
testing and surveillance strategies for other infectious diseases,
including HIV.
NIH and NIAID will continue to build on investments in improved
diagnostic tests for SARS- CoV-2 to support the development of novel
diagnostic tests for other infectious diseases such as HIV. In
addition, lessons learned on the best way to integrate and expand on
existing research efforts and infrastructure will be invaluable as we
continue to prepare for--and respond to-- other existing and emerging
infectious disease threats.
As discussed in response to part a of this question, the Federal
response to the COVID-19 pandemic has strengthened existing
partnerships and coordination mechanisms, as well as established new
partnerships that will inform the response to future infectious disease
pandemics and existing epidemics, such as the HIV/AIDS epidemic in the
United States. The coordinated efforts through RADx and the CoVPN
allowed us to leverage the intrinsic strengths from public and private
sector partners to achieve an unprecedented level of scientific
achievement and community engagement. When the COVID-19 pandemic ends,
lessons learned from our experiences with RADx and the CoVPN will
continue to help inform efforts to address other infectious disease
threats.
NIH and NIAID will continue to work with HHS Operating Divisions
and other Federal agencies to identify the actions that were most
effective in responding to the COVID-19 pandemic. This information may
result in new initiatives, strategic plans, and/or formal assessments
of pandemic preparedness.
______
Questions Submitted by Senator Richard C. Shelby
Question. As America begins to assist the world to vaccinate all
who want it, the current vaccine options can be problematic for
countries without the infrastructure to store vials in a cooled or
frozen environment.
How beneficial could an effective, intranasal vaccine option be for
developing countries that cannot store the current vaccines at frigid
temperatures or produce the healthcare workers to give the shot?
Do you see this option benefitting Americans who may be hesitant to
receive the current vaccine dosage in a shot?
Answer. Global access to safe, effective vaccines will be critical
to address the coronavirus disease 2019 (COVID-19) pandemic. Limiting
the spread of the severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) virus in foreign countries helps to control the pandemic
in those countries while also limiting the development and spread of
variants that could eventually be introduced into the United States. To
enhance vaccine availability in foreign countries, the Biden
Administration has supported and contributed to COVAX, a global
mechanism for equitable access to COVID-19 vaccines. COVAX has
delivered COVID-19 vaccines to more than 100 countries, the majority of
which have lower-income economies. The United States also has made
millions of doses of COVID-19 vaccines available to other countries to
support vaccination campaigns around the world.
Existing COVID-19 vaccines are being successfully administered
globally, and several COVID-19 vaccines authorized for emergency use or
in clinical testing in the United States can be shipped and stored at
refrigerator temperatures (2-8 degrees Celsius). Still, the development
of vaccines that can be administered with less skill and/or stored at
warmer temperatures have the potential to expand vaccination efforts
both in the United States and abroad. The National Institute of Allergy
and Infectious Diseases (NIAID) is supporting the development of
vaccine candidates and platforms that may be more accessible and
convenient than currently available COVID-19 vaccines, including a
single-dose intranasal SARS-CoV-2 vaccine candidate called ChAd-SARS-
CoV-2-S. NIAID scientists and collaborators recently showed that the
intranasal ChAd-SARS-CoV-2-S vaccine candidate limited infection in
non-human primates. Novel vaccines with alternative administration
strategies, such as intranasal vaccines, may reduce barriers to
transporting and administering vaccines in developing countries. It is
important to note, however, that these vaccines may still need to be
kept at low temperatures or may require administration by a healthcare
provider with specialized training to ensure accurate dosing and
administration. For example, FluMist Quadrivalent--a U.S. Food and Drug
Administration-approved intranasal vaccine against influenza--must be
administered by a healthcare provider in the United States.
In addition, National Institutes of Health (NIH) scientists and
NIH-supported researchers are studying additional vaccine delivery
technologies, including vaccines that can be orally administered or
that utilize microneedles in patches placed on the skin to deliver the
vaccine. For example, NIH scientists have begun preclinical evaluation
of a virus-like-particle-based vaccine candidate for SARS-CoV-2 that
can be administered orally, and NIH-supported researchers are
evaluating a patch-based vaccine for SARS-CoV-2. An NIH-supported Phase
I trial of a patch-based vaccine candidate for influenza showed that
individuals that received the vaccine had a similar immune response to
those receiving the influenza vaccine via intramuscular injection. NIH
also is supporting the development of another promising patch-based
vaccine candidate for influenza that uses biodegradable microneedles
originally developed through NIH-supported research to stabilize
vaccines and antibiotics outside of the cold chain. Although additional
testing will be necessary, orally administered and patch-based vaccines
may prove to be an invaluable tool in resource-limited settings as they
may require little to no refrigeration, as well as less training to
administer correctly.
As we work to address the COVID-19 pandemic, as well as other
infectious disease threats, recent innovations in vaccine technology
will help make it easier to get vaccines to areas that can be difficult
to serve with traditional vaccines. NIH continues to support research
on intranasal, oral, and patch-based vaccine platforms, all of which
could be highly adaptable for use against a number of infectious
pathogens.
Vaccines that can be administered intranasally may be considered
less invasive than those that require an injection. Such an option may
encourage individuals who are hesitant to receive the COVID-19 vaccines
currently authorized for emergency use in the United States, which are
all administered via intramuscular injection, to become vaccinated.
Additional vaccine delivery technologies, such as oral or patch-based
vaccines may also provide additional flexibilities when trying to reach
individuals in resource-limited areas or who are vaccine hesitant or
needle adverse. As noted in the response to part a of this question,
NIAID is supporting and will continue to support the development of
vaccine candidates with different delivery technologies to reduce
vaccine hesitancy as well as barriers to vaccine access.
______
Questions Submitted to Dr. Diana Bianchi and Dr. Eliseo Perez-Stable
Questions Submitted by Senator Richard J. Durbin
Question. Our nation continues to struggle with racial disparities,
especially in maternal health. The U.S. is one of only 13 countries
where our nation's maternal mortality rates are worse now than they
were 25 years ago. Every year, 700 women in the U.S. die as a result of
their pregnancy--and more than 60 percent of these deaths are
preventable. Tragically, African American and Hispanic women are three
times as likely as White women to die from pregnancy-related issues.
For years, I have introduced the MOMMA's Act with Rep. Robin Kelly, and
I'm so pleased that a major component of our bill was recently signed
into law as part of the American Rescue Plan. Now states can follow in
Illinois' footsteps by allowing new moms to keep their Medicaid
coverage for a full year, versus just 60 days.
What research NIH is doing in this space?
How is NIH working to actually improve maternal and infant
healthcare?
Answer. Maternal health is a priority for the National Institutes
of Health (NIH) and multiple NIH institutes have heavily invested in
research to prevent maternal morbidity and mortality (MMM) and improve
health for women, before, during, and after pregnancy. In fiscal year
2020 NIH supported $407 million in research on maternal health and $224
million in research on MMM.
In a year that was dominated by both the coronavirus disease 2019
(COVID-19) pandemic and renewed calls to combat health disparities and
inequities, NIH ensured these challenges were integrated into efforts
to reduce MMM. In March 2020, researchers in the Eunice Kennedy Shriver
National Institute of Child Health and Human Development's (NICHD)
Maternal-Fetal Medicine Units Network designed the Gestational Research
Assessments for COVID-19 (GRAVID) study, which evaluated data from more
than 1,200 pregnant women at 33 hospitals across the country and found
that pregnant COVID-19 patients with severe disease are at higher risk
for cesarean delivery, postpartum hemorrhage, hypertensive disorders of
pregnancy, and preterm birth. Data from the study is being shared with
a larger registry to inform future studies of COVID-19's effects on
pregnancy and maternal health.
Tackling the challenge of reducing maternal MMM requires strong
partnerships with and among local communities and resources,
particularly with racial and ethnic minority populations that
experience stark health disparities. To that end, several NIH
Institutes, Centers, and Offices (ICOs) held community engagement
activities to hear first-hand how patient communities can inform future
research and what engagement strategies might enhance local efforts to
improve maternal health. A common refrain was that research conducted
in a community should be developed with and vetted by the community to
ensure success and improved outcomes. These engagement activities
informed the development of the IMPROVE (Implementing a Maternal health
and PRegnancy Outcomes Vision for Everyone) Initiative, which aims to
build an evidence base that will improve maternal care and outcomes
from pregnancy through 1 year postpartum. IMPROVE is co-led by NICHD
and the NIH Office of Research on Women's Health and engages over 30
ICOs to research the leading causes of maternal mortality in the United
States--cardiovascular disease, infection, and immunity--as well as
contributing health conditions or social factors, such as mental health
disorders, diabetes, obesity, substance use disorders, and structural
and healthcare system issues that disproportionately affect Black
pregnant and postpartum women. IMPROVE prioritizes comprehensive,
interdisciplinary research that engages communities with high rates of
maternal deaths and complications. This work will help create tailored,
evidence-based solutions for pregnant and postpartum women.
NIH research on MMM generates evidence that improves outcomes and
clinical care, and several NIH Institutes have strong investments in
this space. For example, an NICHD-funded study demonstrated that when
hospitals implemented evidence-based recommendations for clinical
practice there was a reduction in the risk of severe maternal morbidity
from obstetric hemorrhage, a common complication of childbirth. The
reduction was more dramatic for Black women more than for White women,
reducing disparities and improving outcomes. NICHD is also supporting a
machine learning framework to predict severe maternal morbidity.
Researchers aim to analyze population-based data from Maryland state
databases and hospital surveys to develop techniques that can predict
maternal risks early. Identifying key predictors of severe maternal
morbidity can help ascertain health disparities, strengths and
weaknesses in obstetric care, and prevent adverse maternal and neonatal
outcomes.
In fiscal year 2020, the National Institute on Minority Health and
Health Disparities (NIMHD) started an initiative entitled Addressing
Racial Disparities in Maternal Mortality. This initiative supports
multidisciplinary research projects that examine the clinical, social,
behavioral, and healthcare system interventions to address racial
disparities in MMM in the United States. Additionally, NIMHD funded the
Maternal and Developmental Risks from Environmental and Social
Stressors (MADRES) project in collaboration with the National Institute
on Environmental Health Sciences, to examine prenatal environmental
exposures and social stressors in relation to depression and
cardiovascular risk factors postpartum.
The National Heart, Lung, and Blood Institute (NHLBI) is weaving
together a network of community-engaged researchers who will not only
work to improve women's heart health and reduce maternal mortality, but
will also address other health disparities. For example, NHLBI's new
Maternal Health Community Implementation Program, will fund three or
four regional coalitions to pilot test community-based strategies in
areas where maternal death rates are high, particularly in the
southeast. Additionally, NHLBI's Early Intervention to Promote
Cardiovascular Health of Mothers and Children (ENRICH) will tap into
existing Federal home health/wellness programs that serve at-risk
families to determine if adding a cardiovascular intervention will
enhance maternal and early childhood outcomes. Approximately 3,000
mother- child pairs across various sites will be reached as part of
this effort.
These are just a few examples of how NIH's broad investment in
addressing MMM is improving maternal and infant care.
______
Questions Submitted by Senator Jeanne Shaheen
Question. I am hopeful that our continued investment in the Special
Diabetes Program, and diabetes research at NIH as a whole, can help
spur a new wave of breakthroughs, and maybe one day a cure for
diabetes.
Now that Congress has secured longer-term funding for the Special
Diabetes Program, can you please provide information on NIH's priority
areas for Special Diabetes Program research in the years to come?
Answer. The National Institutes of Health (NIH) appreciates the
recent extension of the Special Diabetes Program, which will allow us
to continue critical ongoing research programs and to support new
research to improve the health and quality of life of people with or at
risk for type 1 diabetes and its complications. For example, the recent
extension will allow the National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK) to continue the Human Islet Research
Network, which is working to better understand how insulin-producing
cells are lost in type 1 diabetes and to find strategies to replace or
protect them in people, toward curing the disease. NIDDK plans to begin
new clinical trials through the Type 1 Diabetes TrialNet network,
testing agents to prevent onset of clinical type 1 diabetes. Such
research will build on the landmark success of previous TrialNet
research demonstrating for the first time ever that early preventive
treatment can delay onset of clinical type 1 diabetes in high-risk
individuals. NIDDK also plans to support research building on the
tremendous recent progress in developing transformative diabetes
management technologies, such as artificial pancreas devices. For
example, future research is needed to improve components of artificial
pancreas devices (e.g., glucose sensors, hormone formulations), develop
simpler and more user-friendly devices, and test devices in
understudied populations (e.g., older adults, pregnant women, people
with poorly controlled blood glucose levels). This type of research
will move us closer to our goal of developing multiple different
artificial pancreas technologies for people of all ages so that they
can choose the technology best suited to their clinical needs. NIDDK
also plans to support new research to identify novel ways to detect and
monitor type 1 diabetes onset and progression, such as by determining
whether ``extracellular vesicles'' that originate from pancreatic
tissue may be useful to detect earlier stages of type 1 diabetes than
currently possible. NIDDK is collaborating with the National Heart,
Lung, and Blood Institute on new research toward reducing
cardiovascular disease in people with type 1 diabetes, as very little
is known about how best to prevent and treat this life-threatening
complication. To inform other future research directions, NIDDK is
spearheading a planning meeting in spring 2022 under the auspices of
the statutory Diabetes Mellitus Interagency Coordinating Committee to
obtain input from external scientific and lay experts on critical new
and emerging research opportunities that could be supported by the
Special Diabetes Program.
Question. New Hampshire continues to be one of the hardest-hit
states in the substance use disorder epidemic, with one of the highest
overdose death rates in the country. I am very supportive of the
ongoing work at the National Institute on Drug Abuse (NIDA) to research
potential non-addictive alternatives to opioids for pain management.
Could you discuss progress on any research within NIDA to study
these types of alternatives?
Answer. The National Institutes of Health (NIH) recognizes the need
to improve pain management without risk of addiction and other serious
side effects. NIH is taking a multi-pronged approach to develop safe
and effective therapies to reduce our reliance on opioids.
To avoid replay of the spike in opioid deaths related to over-use
of medical opioids for pain management we need more effective, non-
addictive pain medications and data that can inform best practices in
pain care. The NIH Helping to End Addiction Long-term (HEAL) Initiative
was launched in 2018 and significantly expanded research to discover
and accelerate development of non-addictive pharmacological and non-
pharmacological pain treatments. HEAL has awarded over $1.5 billion for
research to improve pain management and address opioid use disorder and
overdose. Studies supported by HEAL, the Blueprint Neurotherapeutics
Program, and multiple NIH Institutes, in particular the National
Institute for Neurological Disorders and Stroke (NINDS), are underway
to identify, optimize and test promising molecules, biologics, and
devices that target non-opioid pain pathways in the nervous system.
Biomarker studies to help with diagnosis of pain conditions and to
identify patients most likely to respond to a particular treatment will
enhance pain clinical trials and improve best practices are moving
forward. In addition, non-pharmacological approaches to manage many
different pain conditions are being evaluated through effectiveness and
implementation research approaches.
The NIH HEAL initiative established essential pain research
infrastructure to accelerate development of new medications and devices
to treat pain. An analgesic screening platform uses animal- and human
cell-based models such as neural tissue chips for rapid screening of
molecules or devices for analgesic relevant biological and pain
behavioral activity. HEAL, with input from academic and industry
partners, established an Early Phase Pain Investigation Clinical
research network (phase 2 studies) to test safety and efficacy of novel
therapeutics and a later stage pain management Effectiveness Research
Network (ERN) to compare effectiveness of pharmacological and non-
pharmacological approaches in many different pain conditions. The ERN
is supporting eight large trials for various pain management
strategies. The Pragmatic and Implementation Studies for the Management
of Pain to Reduce Opioid Prescribing (PRISM) network focuses on
clinical trials of non-pharmacologic pain therapies in healthcare
systems.
The Phase 2 network will launch trials on two new analgesics in
2021. The ERN is supporting eight large trials for various pain
management strategies. PRISM is supporting six large trials in
healthcare systems. In addition, HEAL established an analgesic
development pipeline to accelerate the development and testing of novel
drugs and devices. This program uses team-based science coupled with a
comprehensive set of research resources to bring new therapeutics
rapidly to the clinic. To advance the discovery and validation of new
drug targets, HEAL has funded over 30 projects to discover and verify a
diverse set of drug target types across multiple pain conditions, six
drug optimization studies on new safe and effective pain treatments,
and 11 projects to test the effectiveness of implanted devices and
noninvasive stimulation of nerves in the brain or throughout the body
to reduce perception of pain. This effort greatly expands on NINDS
supported studies in these areas.
Recent HEAL accomplishments toward new therapeutics include two
patent filings for small molecule modulators of pain receptors involved
in chronic pain and migraine. One ongoing study received
Investigational New Drug (IND) approval for use of buprenorphine with
nonpharmacological treatment to relieve pain in patients undergoing
kidney dialysis. Through the NIH Blueprint Neurotherapeutics Program
researchers are developing non-addictive kappa opioid receptor
antagonists for treatment of migraine and a safe, non-opioid epoxide
hydrolase inhibitor to reduce diabetic nerve pain. Earlier, NIH
supported basic science research led to calcitonin gene-related peptide
therapy for migraine and nerve growth factor therapy for inflammatory
pain. Drugs that target these molecules are now approved by the U.S.
Food and Drug Administration to treat migraine and osteoarthritis pain.
Through the Brain Research through Advancing Innovative
Neurotechnologies (BRAIN) Initiative, which is a major effort to
develop tools to map, monitor, and modulate neural circuits, NIH has
supported studies that will enhance diagnostics and therapies for
chronic pain and other neural circuit disorders.
Question. The Institutional Development Award (IDeA) program at NIH
has proven critical in funding New Hampshire researchers, including
especially the innovative work at Dartmouth College and Dartmouth-
Hitchcock Health. I am hopeful that Congress can continue to support
funding for this program.
Can you provide any insight into how NIH is currently making use of
Institutional Development Award funds and whether more funding for the
program would be helpful?
Answer. The Institutional Development Award (IDeA) supports basic,
clinical, and translational research, faculty development, and
infrastructure improvements at institutions in states and territories
that have historically received a lower aggregate level of NIH funding.
The program aims to strengthen biomedical research capacity, enhance
the competitiveness of investigators in securing research funding, and
enable clinical and translational research that addresses the specific
needs of rural and medically underserved communities. Currently,
institutions in 23 States and Puerto Rico are eligible for funding
through the IDeA Program, the various components of which include:
--IDeA Networks of Biomedical Research Excellence (INBRE). INBRE
enhances, extends, and strengthens the research capabilities of
biomedical research faculty in IDeA states through a statewide
program that links a research-intensive institution with
primarily undergraduate institutions. INBRE supports
institutional research and infrastructure development; research
by faculty, postdoctoral scientists, and students at
participating institutions; and targeted outreach to build
science and technology knowledge within a state's workforce.
Only one INBRE award is made per IDeA-eligible state. The New
Hampshire INBRE, which is led by Dartmouth and co-led by the
University of New Hampshire, is in its twelfth year of
operation and has used the program's support to improve and
expand research capacity at all eight of its partner
institutions, including adding additional labs, cores and
instrumentation/infrastructure; establishing fully functional
Office of Sponsored Programs for faculty members to
competitively seek extramural grants; training and mentoring of
both faculty and students; and enhancing a vibrant
institutional research culture. In fiscal year 2020, the
National Institute of General Medical Sciences (NIGMS)
supported 24 INBRE awards.
--Centers of Biomedical Research Excellence (COBRE--Phases I, II, and
III). COBRE supports the establishment and development of
innovative, state-of-the-art biomedical and behavioral research
centers at institutions in IDeA-eligible states that: (a)
galvanize multidisciplinary research to develop a critical mass
of investigators that are competitive for peer-reviewed
research funding; (b) provide improvements to research
infrastructure; and (c) maintain research cores to sustain a
collaborative, multidisciplinary research environment that
includes pilot project programs, mentoring, and workforce
training. In fiscal year 2020, NIGMS supported 112 COBRE
awards. One such example, a Phase I COBRE at Dartmouth's Geisel
School of Medicine called iTarget (Institute for Biomolecular
Targeting), aims to catalyze the development of new therapeutic
approaches to address cancer, chronic obstructive pulmonary
disease, and respiratory syncytial virus, a common viral
infection that can be dangerous to young children and the
elderly. This COBRE is providing unique resources to
investigators at Dartmouth and its IDeA partners, thus
enhancing research productivity and funding competitiveness
across the region.
--IDeA Networks for Clinical and Translational Research (IDeA-CTR).
IDeA-CTRs develop a network infrastructure and capacity in
IDeA-eligible states to conduct clinical and translational
research focused on health concerns that disproportionately
affect rural and medically underserved populations and/or that
are prevalent in IDeA states. IDeA-CTR awards support mentoring
and career development activities in clinical and translational
research. In fiscal year 2020, NIGMS supported 12 IDeA-CTR
awards.
--Regional Technology Transfer Accelerator Hubs. NIGMS established
the Regional Technology Transfer Accelerator Hubs for IDeA
states in each of the four IDeA regions (central, northeast,
southeast, and western regions). The hubs provide both
consulting services and skills development in entrepreneurship,
technology transfer, small business finance, and other areas
needed to transform important discoveries made in the
laboratory into potentially viable commercial products that
address human health. In fiscal year 2020, NIGMS supported four
accelerator hubs. The northeast hub is located at Celdara
Medical in Lebanon, New Hampshire.
--Research Co-Funding. NIGMS provides co-funding for applications
from IDeA state institutions that have been judged meritorious
by NIH peer-review committees and national advisory councils
but that may also fall outside the usual range of support by a
given NIH Institute or Center (IC). In fiscal year 2020, NIGMS
co-funded 42 research project grants at 20 NIH ICs; one of
these was at Dartmouth College.
______
Questions Submitted to Dr. Ned Sharpless
Questions Submitted by Senator Patty Murray
Question. The American Cancer Society's Annual Report to the Nation
on the Status of Cancer highlighted that we are making good progress in
the battle against cancer, with the incidence and mortality rates for
most cancers have dropped significantly. However, among the 20 most
common cancers, relative survival for patients significantly improved
since the mid-1970s except for those with uterine cancer.
What plans does the NCI have in fiscal year 2022 to develop a
paradigm of increased research to improve hope for survival for
patients with uterine cancer?
Answer. The National Cancer Institute (NCI) shares the committee's
commitment to research on uterine cancers, including endometrial cancer
(cancer of the inner lining of the uterus), and improving outcomes for
patients.
Today, nearly 40 percent of adults are obese, and without
intervention, the obesity epidemic will result in more cancers. Uterine
cancer incidence and mortality have increased in recent years,\40\
believed to be partially associated with rising rates of obesity.\41\
Women who are obese or overweight are approximately two to four times
as likely as normal weight women to develop uterine cancer, including
endometrial cancer, making interventions to address weight and obesity
vital to combatting uterine cancer incidence and mortality. Examples of
NCI-supported research on this topic include a study of how changes in
body composition following weight loss impact inflammatory biomarkers
in biopsy-collected endometrial tissue and blood samples and whether
these processes differ between Black and White women; \42\ the
development of a weight loss intervention among Appalachian residents;
\43\ and a study of the Deep South Interactive Voice Response (IVR)-
supported Active Lifestyle (DIAL) Intervention to increase physical
activity levels among residents of the Deep South.\44\
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\40\ pubmed.ncbi.nlm.nih.gov/30521505/,seer.cancer.gov/
report_to_nation/statistics.html#
factors.
\41\ www.cancer.gov/about-cancer/causes-prevention/risk/obesity/
obesity-fact-sheet.
\42\ reporter.nih.gov/project-details/10129305.
\43\ reporter.nih.gov/project-details/10065366.
\44\ reporter.nih.gov/project-details/10163139.
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Researchers at the University of North Carolina Lineberger
Comprehensive Cancer Center are directly examining the metabolic and
molecular differences of endometrial tumors in obese and non-obese
women. In addition, this research team is exploring how metformin,
widely used to treat type II diabetes, may also exhibit anti-tumor
activity through its effects on a patient's metabolism.\45\
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\45\ reporter.nih.gov/project-details/10104456.
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Translational research to bridge the gap between basic research on
endometrial cancer and potential therapies is also essential to
improving outcomes for patients. NCI supports a Specialized Program of
Research Excellence (SPORE) focused on translational research for
endometrial cancer at the University of Texas/MD Anderson Cancer
Center. This SPORE is conducting research aimed at developing
therapeutic strategies for advanced/recurrent endometrial cancer and
aggressive subtypes, addressing unmet clinical needs in prevention and
conservative therapy of high-risk precancerous lesions and low-grade
endometrial cancer, and incorporating molecular diagnostics into
clinical decisionmaking.\46\
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\46\ trp.cancer.gov/spores/endometrial.htm.
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As of July 2021, NCI is supporting over 150 clinical trials with a
primary focus on uterine (including endometrial) cancer. Examples of
these projects include studies of the use of an immunotherapy agent, in
combination with other cancer therapies, to treat high risk endometrial
cancer; \47,48\ a trial examining a combination therapy to treat
endometrial cancers that express the HER2 protein; \49\ and a study
evaluating the use of the experimental therapy triapine to treat
endometrial serous adenocarcinoma, a difficult to treat subtype of
uterine cancer.\50\ Clinical trials are an integral part of advancing
research in this important topic area, and NCI is committed to reaching
out to disparate, at-risk communities to explain, educate, and
encourage clinical trial participation.
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\47\ clinicaltrials.gov/ct2/show/NCT04214067.
\48\ clinicaltrials.gov/ct2/show/NCT03914612.
\49\ clinicaltrials.gov/ct2/show/NCT04585958.
\50\ clinicaltrials.gov/ct2/show/NCT04494113.
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As part of the National Institutes of Health (NIH) efforts to
identify future research directions, NCI and the Eunice Kennedy Shriver
National Institute of Child Health and Human Development (NICHD)
explored research opportunities into the progression of benign
gynecologic conditions to cancers through a collaborative workshop in
April 2019. Currently, NICHD funds research on benign gynecologic
conditions such as endometriosis and uterine fibroids, while NCI funds
research on women's cancers. The workshop sought to bridge the two
research areas and identify gaps in the biologic, epidemiologic, and
clinical understanding of progression from benign conditions to cancer.
The workshop addressed three gynecologic disease types: (1)
endometriosis or endometrial cancer and endometrial-associated ovarian
cancer, (2) uterine fibroids (leiomyoma) or leiomyosarcoma, and (3)
denomyosis or adenocarcinoma. Working groups were formed for each
disease type, and key questions and current challenges that emerged
from the discussions, along with potential research opportunities to
advance understanding of progression of gynecologic benign conditions
to cancer, were published. Specific research questions and gaps were
identified in all three focus areas, and several cross-cutting topics
emerged. The results of this workshop, as well as ongoing horizon-
scanning activities, will continue to inform NIH's next steps to
address uterine cancer.
Question. Non-Hispanic Black women are two time as likely as non-
Hispanic White women to die from uterine or cervical cancer (https://
www.ajog.org/article/S0002-9378(16)46212- 5/pdf).
Can NIH/NCI please share with the Committee the research activities
the NCI is supporting to address this disparity, particularly with
regards to access to care, prevention, early diagnosis, treatment
completion and developmental therapeutics?
Answer. The National Cancer Institute (NCI) shares the Committee's
concern regarding cervical and uterine/endometrial cancer disparities
and is working to support research to eliminate these disparities, as
well as cancer disparities more broadly. Examples of research aimed at
addressing disparities in uterine and cervical cancer outcomes are
provided below.
NCI is a leader in developing and supporting definitive, practice-
changing gynecologic (GYN) clinical trials, as well as responding to
areas of scientific inquiry that are unaddressed by private industry.
The NCI GYN Cancers Steering Committee sets clinical trials strategic
priorities that address areas of unmet clinical need, important
unanswered clinical questions, and potential new approaches to disease
treatment.\51\ The Institute has supported and advanced GYN cancer
research that will provide greater insight into these cancers,
additional options for drug therapies, and improved surgical techniques
with the intent of increasing survivorship and quality of life. As of
July 2021, NCI is supporting over 150 interventional clinical trials
with a primary focus on uterine (including endometrial) cancer, two
trials on the rare uterine sarcoma, and nearly 100 trials for cervical
cancer patients. NCI also has several trials that are ``disease
agnostic,'' meaning that they are open to patients with certain genetic
alterations rather than traditional cancer types, creating
opportunities for patients to potentially benefit from precision
medicine and targeted therapy.
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\51\ www.cancer.gov/about-nci/organization/ccct/steering-
committees/nctn/gynecologic.
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A recent study led by NCI intramural researchers used population
data from NCI's Surveillance, Epidemiology, and End Results (SEER)
database to evaluate trends of hysterectomy-corrected uterine cancer
incidence rates for women overall and by race and ethnicity, geographic
region, and histologic subtype. Correct estimation of these rates
requires accounting for hysterectomy prevalence, which varies by race,
ethnicity, and region. The researchers found that incidence rates of
common subtypes of uterine cancer were stable in non-Hispanic White
women over the study period and increased in women of other racial/
ethnic groups. By contrast, incidence rates of aggressive subtypes have
been increasing dramatically over time in all racial/ethnic groups; in
particular, much higher rates of these aggressive subtypes were
observed in Black women than in other racial/ethnic groups. The
researchers also observed that survival rates were lower among all
women with aggressive subtypes than among women with common subtypes,
and Black women had the lowest survival rates within each stage at
diagnosis or histologic subtype.
Uterine serous carcinoma (USC) is a rare but aggressive type of
endometrial cancer. In about one-third of women with USC, their tumor
cells overproduce a protein called HER2 (human epidermal growth factor
receptor 2), which is associated with poor prognosis in women with
endometrial cancer. Black women with endometrial cancer are more likely
than White women to be diagnosed with UCS and are more likely than
women of other races/ethnicities to have HER2 overproducing UCS tumors.
NCI clinical studies for patients with HER2 overproducing uterine
serous cancer and carcinosarcoma are currently in development.
NCI-supported researchers are working to describe additional
differences in subtypes of uterine and endometrial cancers, with the
eventual goal of targeting therapies to treat each disease subtype. For
example, investigators at Brigham and Women's Hospital, using data from
the NCI-supported Epidemiology of Endometrial Cancer Consortium
(E2C2),\52\ are studying genomic variation across the full spectrum of
endometrial tumors, distinct risk factor profiles across tumor types,
and the role of underlying tumor biology to better understand the
disparities in outcomes between African-American and non-African-
American women.\53\ NCI-supported investigators at Wayne State
University are examining aggressive subtypes of high-grade endometrial
tumors, including endometrioid, serous, clear cell and mixed
carcinomas, by analyzing both clinical and genetic data in 500 women
(250 African-American, 250 White) diagnosed with these cancers.\54\ In
addition, NCI is supporting a planning grant to establish a Specialized
Program of Research Excellence (SPORE) at Northwestern University
focused on gynecologic cancer disparities. One of the pilot projects
will focus on the tumor genomics of endometrial cancer.\55\
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\52\ epi.grants.cancer.gov/eecc/.
\53\ reporter.nih.gov/search/o5KPkwNzZUavBogOfHXfCgproject-details/
10156374.
\54\ reporter.nih.gov/search/frdhnx_EQkONjxE8GPyxvQ/project-
details/9916725.
\55\ reporter.nih.gov/search/-UP_KUgEu0G9_0Zt655Nsg/project-
details/9961257.
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To more accurately evaluate the risk of cervical precancer and
study novel biomarkers in women undergoing cervical cancer screening,
intramural researchers in NCI's Division of Cancer Epidemiology and
Genetics have partnered with the University of Mississippi Medical
Center and the Mississippi State Department of Health in the STRIDES
Study (Studying Risks to Improve Disparities of cervical cancer in
Mississippi). This study, based in one of the top five states for
cervical cancer incidence and mortality, combines the expertise of
clinicians, laboratory scientists, epidemiologists, and implementation
scientists to address all aspects of cervical cancer prevention and
control.\56\
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\56\ dceg.cancer.gov/research/cancer-types/cervix/cervix-
mississippi.
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In 2020, NCI launched the ``Last Mile Initiative,'' with the goal
of improving cervical cancer screening coverage to underserved, never
screened, and under-screened women. This initiative will evaluate an
alternative cervical cancer screening approach: self-collection of
samples (self- sampling) by women, which are then sent to labs for
human papillomavirus (HPV) testing. This approach aims to identify
cervical cancer cases in these groups of women, which account for over
half of cervical cancer cases in the United States each year. Self-
sampling offers several benefits, including ease of collection at the
time and place of the patient's choosing, without the need for a clinic
appointment or speculum exam. To conduct this assessment, NCI
established a public-private partnership between Federal agencies,
industry partners, and professional societies/clinical guidelines
organizations, and will support a nationwide, multicentric screening
trial in diverse settings, the Last Mile Initiative Self-sampling for
HPV Testing to Improve Cervical Cancer Prevention Trial (LMI-SHIP
Trial).\57\
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\57\ prevention.cancer.gov/major-programs/nci-cervical-cancer-last-
mile-initiative.
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Additionally, NCI is collaborating with the NIH Office of Research
on Women's Health (ORWH) and other NIH Institutes and Centers to
participate in an ORWH Advisory Committee on Research on Women's Health
Consensus Conference to be held in October 2021. The conference will
include a focus on cervical cancer disparities and research
opportunities to continue to address disparities in incidence and
mortality.
NCI will continue to identify opportunities to better understand
and address cancer health disparities, including for cervical and
uterine/endometrial cancers.
______
Questions Submitted by Senator Richard J. Durbin
Question. Approximately 20,000 people in the United States have
germline mutations in the gene RUNX1. Patients with RUNX1-familial
platelet disorder are at a heightened risk for developing blood
cancers. NCI supports a longitudinal natural history study of patients
with such germline mutations and their families. While germline RUNX1
mutations are rare, I understand that NIH-funded research in this area
holds promise for the fields of hematology and oncology.
How can deepening our understanding of, and ultimately developing
cancer prevention strategies for, inherited blood cancer predisposition
syndromes like RUNX1 familiar platelet disorder advance the entire
cancer research field forward?
Answer. The RUNX1 gene regulates the development of blood cells
(hematopoiesis), controlling other genes that help determine the fate
of hematopoietic stem cells, which have the potential to develop into
all types of mature blood cells, including platelets. Platelets are
cells that help blood to clot. Inherited mutations in the RUNX1 gene
cause familial platelet disorder with associated myeloid malignancies
(RUNX1-FPDMM) and predispose individuals to some types of blood
cancers. Although genetic predisposition to solid tumors such as breast
and colon cancers has been widely recognized over the past several
decades, the contribution of inherited genetic disorders related to
blood cancer is a more recent field of study.
There are many instances where understanding the molecular basis
for a rare inherited disease has provided insight into more common
forms of a particular disease. For example, BRCA1 and BRCA2 mutations
were discovered as hereditary breast cancer genes but are also relevant
to sporadic (non-hereditary) breast cancers, ovarian cancers, and some
hereditary forms of colon cancer. Similarly, understanding the blood
cancers associated with RUNX1-FPDMM may lead to improved understanding
of other types of blood cancers as well.
Research efforts across the National Institutes of Health (NIH) are
underway to better understand RUNX1-FPDMM. Investigators funded by the
National Heart, Lung, and Blood Institute (NHLBI) are studying cells
from people with this disorder to better understand key target genes
regulated by RUNX1 and their role in hematopoiesis.\58\ This work could
also yield a better understanding of genetic pathways that lead to
blood cancers, as well as the blood clotting mechanisms that contribute
to cardiovascular disease. Investigators at the National Human Genome
Research Institute (NHGRI), along with intramural scientists at the
National Cancer Institute (NCI), are conducting a natural history study
at the NIH Clinical Center that is intended to identify and follow
patients with RUNX1 mutations to hopefully identify biomarkers that can
predict which patients will develop cancers.\59\ To date, the study has
enrolled 198 patients from 55 families, representing the largest FPDMM
cohort being followed prospectively at a single institution in the
world.
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\58\ reporter.nih.gov/project-details/10083753.
\59\ www.genome.gov/Current-NHGRI-Clinical-Studies/hematologic-and-
premalignant-conditions-associated-with-RUNX1-
mutation;clinicalstudies.info.nih.gov/ProtocolDetails.
aspx?id=2019-HG-0059; clinicaltrials.gov/ct2/show/NCT03854318.
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Studying RUNX1-FPDMM will have broader significance than just this
rare disease. Germline (inherited) predisposition to hematopoietic
malignancies is often under-diagnosed, with recent studies indicating
that 10-30 percent of RUNX1 mutations detected in acute myeloid
leukemias are inherited, which is much more common than previously
appreciated.\60\ In addition, FPDMM can serve as a model to study the
development of leukemia, since researchers can monitor individuals with
the RUNX1 mutation before they develop leukemia to identify factors
associated with cancer risk and to map tumor evolution.
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\60\ pubmed.ncbi.nlm.nih.gov/32315381/.
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______
Questions Submitted by Senator Jack Reed
Question. The fiscal year 2021 Appropriations law included full
funding--$30 million--for the Childhood Cancer STAR Act, which I
authored.
Could you provide an update on how that funding will be spent in
the coming year?
How will that work be coordinated with the childhood cancer data
initiative?
Answer. NCI is supporting several new and ongoing Childhood Cancer
STAR Act research projects in fiscal year 2021, for a total planned
investment of $28 million. The Centers for Disease Control and
Prevention continues to support enhancements to expand capacity within
the National Program of Cancer Registries (NPCR) to help cancer
registries collect and make the data on pediatric cancer cases
available more rapidly, a $2 million effort in fiscal year 2021.
Consistent with provisions in Section 101 of the STAR Act, NCI's
fiscal year 2021 appropriation for STAR Act activities is supporting
new and expanded projects focused on the collection and storage of
biospecimens for future research. Several projects are conducted
through the NCI-supported Children's Oncology Group (COG) to focus
additional attention to rare cancer subtypes that are currently
underrepresented in NCI-supported biorepositories, as well as tumor
types with a high risk of treatment failure. For example, particularly
rare subtypes of pediatric cancers for which COG does not have open
clinical trials, tumor tissue collection options are limited. STAR Act
appropriations are supporting the COG Rare and Under-Represented Cancer
Tissue Banking project to enable tumor tissue and associated germline
(e.g., blood) sample collection for specific groups of patients for
which current tumor tissue collection is lacking or inadequate, with
priority for tumor types such as sarcomas and brain and central nervous
system (CNS) tumors, which have high risk of treatment failure.
The COG Rare and Under-Represented Cancer Tissue Banking project
was launched in fiscal year 2020 and is expanding in scope in fiscal
year 2021. This initiative is collaborating closely with CCDI, and with
the use of fiscal year 2021 CCDI funds, tumor tissue will undergo
clinically-relevant molecular profiling through the CCDI Molecular
Characterization Protocol. The data generated will be returned to
treating physicians to help guide the diagnosis and treatment of
patients, and the data will additionally be stored and made available
to the research community through CCDI data platforms. In addition to
rare cancer populations, the CCDI Molecular Characterization Protocol
will initially support characterization of tumors from children with
CNS tumors and from children with soft tissue sarcomas. The Protocol
aims to collect, store, and make available detailed clinical and
molecular information for each child participating in the study,
including data that will help a pediatric oncologist treat that patient
and help researchers learn more about childhood cancers.
NCI is continuing support in fiscal year 2021 for other STAR Act
biobanking projects launched in fiscal year 2020. Through the COG Rapid
Autopsy Specimen Collection project, NCI and COG are working with
patient organizations to support rapid autopsy collection of tumor
samples from children and adolescents and young adults (AYAs) who have
died of their disease. Foundations and families within the pediatric
brain tumor community have been leaders in such programs, and NCI
continues to learn from their experiences to expand this model to other
childhood cancers. We are incredibly grateful to these parents and
caregivers, who amidst unimaginable grief and loss, contribute to
future research to advance science and help other families.
NCI is also supporting the COG to continue to expand the collection
of specimens taken at the time of relapse, as well as collecting
diagnostic samples for children and AYAs who have already submitted
samples at relapse through NCI's Pediatric Molecular Analysis for
Therapy and Choice (MATCH) Precision Medicine Trial. An important
impediment to understanding mechanisms of treatment failure for
childhood solid tumors is the limited numbers of paired specimens from
both diagnosis and relapse that are available for researchers to study.
Specimens at relapse are critical for evaluating biological changes
between diagnosis and relapse that can lead to the identification of
mechanisms of treatment failure and to the development of strategies
for circumventing these mechanisms. Through CCDI, Pediatric MATCH tumor
specimens from diagnosis and from relapse are being molecularly
characterized to identify the changes in gene mutations and gene
expression that occur between diagnosis and relapse, which could inform
better treatments.
Consistent with Section 202 of the STAR Act, in fiscal year 2021,
NCI will continue to conduct and support childhood cancer survivorship
research. NCI has supported two new Requests for Applications (RFAs)
since fiscal year 2019 that are directly aligned with survivorship
research areas emphasized in the STAR Act. Issued in fiscal year 2019,
RFA CA-19-033: \61\ Improving Outcomes for Pediatric, Adolescent and
Young Adult Cancer Survivors focused on projects to develop and test
interventions that prevent, mitigate or manage adverse outcomes in
pediatric and/or AYA cancer survivors and/or evaluate models of care
that strengthen coordination, continuity, and quality, or that reduce
access barriers to needed services including follow-up care, and that
improve outcomes across the survivor's lifespan. Development of
interventions to address disparities in outcomes and/or access to
needed care, and to address the needs of minority or medically
underserved pediatric and/or AYA populations were also prioritized. NCI
is supporting seven awards in response to this RFA, and the awards will
focus on various patient sub-populations (e.g. disease site),
developmental groups, specific late and long-term effects, and the
types of interventions (both preventive and supportive care).
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\61\ grants.nih.gov/grants/guide/rfa-files/RFA-ca-19-033.html.
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Issued in fiscal year 2020, RFA CA-20-027 \62\ and RFA CA-20-028:
\63\ Research to Reduce Morbidity and Improve Care for Pediatric, and
Adolescent and Young Adult (AYA) Cancer Survivors invite applications
for research projects to improve care and health-related quality of
life for childhood and AYA cancer survivors, with a focus on six key
domains that align with research priorities emphasized in the STAR Act:
(1) disparities in survivor outcomes; (2) barriers to follow-up care
(e.g. access, adherence); (3) impact of familial, socioeconomic, and
other environmental factors on survivor outcomes; (4) indicators for
long-term follow-up needs related to risk for late effects, recurrence,
and subsequent cancers; (5) risk factors and predictors of late/long-
term effects of cancer treatment; and (6) development of targeted
interventions to reduce the burden of cancer for pediatric/AYA
survivors.
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\62\ grants.nih.gov/grants/guide/rfa-files/RFA-CA-20-027.html.
\63\ grants.nih.gov/grants/guide/rfa-files/rfa-ca-20-028.html.
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In fiscal year 2021, NCI will support subsequent years for grants
initially awarded in fiscal year 2019 and fiscal year 2020, as awards
were made for five-year terms, and the Institute will be making several
new grant awards through the RFA launched in fiscal year 2020. The
first round of applications is in the final stages of review, and
awards will be made before the close of fiscal year 2021. The second
round of applications are due on July 30, 2021, and awards are
anticipated to be made in fiscal year 2022.
NCI also continues to make additional investments in childhood
cancer survivorship research beyond the STAR Act appropriation, funding
several notable initiatives and projects with resources provided
through the Institute's general appropriation. For example, NCI
continues to fund long-standing investments in the Childhood Cancer
Survivor Study (CCSS),\64\ which the Institute has supported
continuously since establishing CCSS in 1994. This cohort of more than
38,000 childhood cancer survivors diagnosed between 1970 and 1999 (and
5,000 siblings of survivors who serve as the comparison group for the
study) serves as a foundational resource for the survivorship research
community.
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\64\ cancer.gov/types/childhood-cancers/ccss.
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Additionally, NCI continues to support research projects that
investigators develop and submit independent of specific childhood and
AYA cancer survivorship funding opportunities such as the STAR Act RFAs
described above. These investigator-initiated research projects provide
critical contributions to this field, and awards made to date in fiscal
year 2021 include a project to compare symptom burdens (toxicity),
neurocognitive change, and functional outcomes in children with
pediatric brain tumors treated with proton versus photon radiotherapy.
Proton beam radiotherapy (PBRT) is often thought to be a promising
treatment for children with brain tumors as it may preserve cognitive
functioning without sacrificing disease control. This will be the first
large-scale study to prospectively compare the two therapies to assess
important measures of daily functioning that will quantify the clinical
significance of any differences identified between groups in
survivorship. This project aims to help physicians and families better
understand the relative effect of PBRT on symptoms and neurocognitive
functioning to inform treatment decisions.\65\ Another award is
supporting further study of psychosocial risk in young survivors of
pediatric cancer diagnosed in early childhood, including the role of
both physical and neurocognitive late effects. This project aims to
identify specific medical and neurocognitive late effects that increase
psychosocial morbidity, as well as protective factors, to inform more
effective interventions to optimize quality of life in children
affected by cancers diagnosed in early childhood.\66\ In addition, the
NCI-supported ASPIRES (Activating cancer Survivors and their Primary
care providers to Increase coloREctal cancer Screening) study aims to
prevent the development of subsequent cancers among childhood cancer
survivors treated with abdominal or pelvic radiotherapy, who are almost
four times more likely to develop colorectal cancer (CRC) compared to
the general population. The study will test a remote intervention aimed
at promoting early CRC screening and detection.\67\
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\65\ reporter.nih.gov/search/kPIDddsyREmcoShhVEYN4Q/project-
details/10146799.
\66\ reporter.nih.gov/search/5Nb7PgFn7kyHJnjYOFzMQA/project-
details/10122486.
\67\ reporter.nih.gov/search/5Nb7PgFn7kyHJnjYOFzMQA/project-
details/10096080.
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NCI remains committed to implementing the research sections of the
STAR Act directed toward the Institute, and to ensuring that these
efforts continue to complement the Institute's broader portfolio of
childhood and AYA cancer research. This includes CCDI, the COG, the
CCSS, and many other research programs and projects working together to
support much needed progress for children with cancer and their
families, including survivors and caregivers facing the challenges of
managing the late effects of cancer and its treatments.
______
Questions Submitted by Senator Roy Blunt
Question. Dr. Sharpless, one of the goals I had when I was Chairman
of this Subcommittee was to increase NIH funding, in an effort to
increase the success rates of grants--meaning more research grants
would be funded. This is important because the NIH peer review system
does not always reward high-risk science or young researchers' grant
applications. But, if you have additional funding, you can fund more
than just the `safest' science grants from the most established
researchers. NCI has seen an increase of more than 50 percent in the
number of grant applications since 2013, keeping your success rates and
paylines lower than most NIH Institutes. While the positive aspect of
this statistic is that the cancer research community is energized and
applying for NCI funding, you can only fund a certain amount of
applications because of the significant increase in grant applications.
The last two LHHS bills have included specific funding for NCI to
increase their Research Project Grants.
How has this allowed you to increase success rates, raise the
payline, and make more awards?
Answer. The intense competition and demand for NCI funding reflects
incredible scientific opportunities in cancer research and presents a
major challenge for the NCI to carefully balance increasing demand for
competing grant funding while sustaining previous years' commitments to
multi-year grants.
Investigator-initiated research has proven itself to be one of the
biggest drivers of progress in cancer research, and accordingly is the
biggest driver of NCI's budget, with long-term investments into funding
new and continuing awards constituting more than 40 percent of NCI's
annual budget. These awards have been the source of some of the most
innovative and transformative ideas in cancer research, leading to
direct benefits for patients in the form of new oncology drug
approvals, the development of immune checkpoint inhibitor therapy
(Nobel Laureate Jim Allison), CAR-T (chimeric antigen receptor-T) cell
immunotherapy (Carl June), and novel drug design strategies such as
PROTACs (proteolysis targeting chimeras) \68\ that use normal cellular
processes to identify and destroy proteins in cancer cells that drive
cancer growth (Raymond DeShais and Craig Crews).
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\68\ www.cancer.gov/research/annual-plan/scientific-topics/protac-
infographic.
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Considering all funding mechanisms, NCI supported 109 additional
awards in fiscal year 2020 as compared to fiscal year 2019 (from 6,053
in fiscal year 2019 \69\ to 6,162 in fiscal year 2020 \70\). Across
fiscal year 2020 and 2021, the successive funding increases allowed NCI
to increase the R01 payline from the 8th percentile in fiscal year 2019
to the 11th percentile in fiscal year 2021. With the fiscal year 2020
budget increase, NCI increased R01 paylines by 25 percent compared to
fiscal year 2019 and restored continuing grants to 100 percent of their
committed level, providing researchers the full fiscal year 2020 budget
approved during the initial grant award. Funding increases in fiscal
year 2021 allowed NCI to further raise the payline for R01 research
awards, for an overall 35 percent increase compared to 2019, as well as
to keep funding continuing awards at 100 percent. In addition, for
those two consecutive years (fiscal year 2020 and fiscal year 2021),
NCI also raised the payline for Early-Stage Investigators, reflecting
NCI's commitment to developing and supporting early career scientists
to build the next generation of cancer researchers.
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\69\ www.cancer.gov/about-nci/budget/congressional-justification/
fy2021-nci-congressional-justification.pdf.
\70\ www.cancer.gov/about-nci/budget/congressional-justification/
fy2022-nci-congressional-justification.pdf.
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We have the final success rate and total number of awards results
for fiscal year 2020, the year when Congress targeted an additional
$212.5 million for new and continuing grants, but we will not have
final results for fiscal year 2021 until after the first quarter of
fiscal year 2022. Our fiscal year 2020 results show that NCI increased
the number of competing R01s we issued within the payline by more than
100 awards, a jump of more than 15 percent from the prior year. The
funding increase also allowed us to pay other meritorious R01
applications that scored just outside the payline. Overall, our success
rate for fiscal year 2020 rose to 12.7 percent, from 11.6 percent in
the prior year.
The targeted increases that Congress has provided allows NCI to
increase paylines, achieve a corresponding increase in the overall NCI
application success rate, and issue more grant awards. This funding has
been critical to awarding new grants, while also allowing NCI to
support ongoing research and the breadth of core NCI research
investments, such as NCI's designated cancer centers, Specialized
Programs of Research Excellence (SPOREs), and large national networks
of clinical trials. All of these awards and programs will continue to
fuel broad, sustained progress that serves the needs of individuals
with cancer and those at risk of cancer, leading to a deeper
understanding of the biology of cancer and new strategies to prevent,
screen, diagnose, and treat cancer, in all its forms.
______
Questions Submitted by Senator Shelley Moore Capito
Question. The NCI is doing tremendous work in implementing the new
Childhood Cancer Data Initiative, which holds the promise of vastly
improving the treatment of childhood cancer and the quality of life for
survivors. The Childhood Cancer STAR Act calls for a major investment
in biorepository and bio-specimen collection.
Can you tell us how these two vital initiatives are working
together? NIH Response:
Answer. The National Cancer Institute (NCI) agrees that it is vital
for biospecimen collection and storage efforts supported through the
STAR Act and data generation, analysis, and sharing supported through
Childhood Cancer Data Initiative (CCDI) to continue to contribute to
and enhance each initiative's progress in a complementary manner. To
that end, NCI is utilizing STAR Act appropriations to support the
Children's Oncology Group (COG) Rare Tumor Populations Biobanking
project, which enables tumor tissue and germline (e.g., blood)
collection for specific groups of patients for which current tumor
tissue collection is lacking or inadequate, with priority for tumor
types such as sarcomas and brain and central nervous system tumors,
which often have the highest risk of treatment failure.
The COG Rare Tumor Populations Biobank was launched in fiscal year
2020 and is expanding in scope in fiscal year 2021. This initiative is
collaborating closely with CCDI, and with the use of fiscal year 2021
CCDI funds, tumor tissue will undergo clinically-relevant molecular
profiling through the CCDI Molecular Characterization Protocol. The COG
Rare Tumor Populations Biobank provides a critical foundation for these
characterization efforts within CCDI. The data generated will be
returned to treating physicians to help guide the diagnosis and
treatment of patients, and the data will be stored and made available
to the research community through CCDI data platforms. In addition to
rare cancer populations, the CCDI Molecular Characterization Protocol
will initially support characterization of tumors from children with
Central Nervous System (CNS) tumors and from children with soft tissue
sarcomas. The Protocol aims to collect, store, and make available
detailed clinical and molecular information for each child
participating in the study, including data that will help a pediatric
oncologist treat that patient and help researchers learn more about
childhood cancers.
NCI is also supporting a STAR Act biobanking project through the
COG to continue to expand the collection of specimens taken at the time
of relapse, as well as collecting diagnostic samples for children and
adolescents and young adults (AYAs) who have already submitted samples
at relapse through NCI's Pediatric Molecular Analysis for Therapy and
Choice (MATCH) Precision Medicine Trial. An important impediment to
understanding mechanisms of treatment failure for childhood solid
tumors is the limited numbers of paired specimens from both diagnosis
and relapse that are available for researchers to study. Specimens at
relapse are critical for evaluating biological changes between
diagnosis and relapse that can lead to the identification of mechanisms
of treatment failure and to the development of strategies for
circumventing these mechanisms. Through CCDI, Pediatric MATCH tumor
specimens from diagnosis and from relapse are being molecularly
characterized to identify the changes in gene mutations and gene
expression that occur between diagnosis and relapse, which could inform
better treatments.
These are specific examples of early and ongoing collaboration
between STAR Act and CCDI- supported projects, and more broadly, there
will be additional opportunities for data generated through STAR Act
specimen collection and survivorship research efforts to contribute to
the CCDI data ecosystem. For example, other STAR Act biobanking
projects have supported additional biospecimen collection within the
NCI-supported Childhood Cancer Survivor Study (CCSS), focused on
subsequent cancers and chronic health conditions. CCDI funds were used
to molecularly characterize specimens from patients who developed
second cancers to enhance understanding of the genetic factors that
lead to increased risk of second malignant tumors. Additionally, CCDI
funds have supported submission and management of CCSS data to NCI and
other NIH repositories so that they can be linked within the CCDI data
ecosystem and more easily shared with the broader research community.
As NCI's CCDI continues to link data resources across the childhood
cancer research field, we envision these linkages and the data
ecosystem they create serving as a resource for continued research, and
as a growing repository for all types of data generated through NCI and
other funded childhood and AYA cancer research. Similar to the CCSS,
individual research projects, including preclinical studies and
clinical trials, will have the opportunity to contribute data to CCDI,
linking this additional data to CCDI resources such as the Molecular
Characterization Protocol and the National Childhood Cancer Registry,
two foundational CCDI initiatives.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. I, along with many members of the committee remain
concerned with the lack of targeted therapies for rare cancer patients.
It is my understanding that rare cancers account for 380 of 400
distinct forms of cancer and almost 1/3 of all diagnoses and include
all pediatric cancers. A recent analysis showed that 80 percent of all
patients who lacked an FDA-targeted therapy were rare cancer patients.
In addition, of the 3,994 clinical trials in phases 1, 2, and 3 from
January 1, 2012 to January 1, 2017, almost 75 percent did not include a
rare cancer by name. While rare cancer affects every population,
translational research and commercial drug development has
traditionally neglected small patient populations. Each subtype of
cancer requires a targeted therapy in order to save a life or to
significantly improve lifespan.
What is NIH's plan to ensure there are adequate investments for
treatments for rare cancer patients and what can Congress and this
committee do to help?
Answer. The National Institutes of Health (NIH) remains committed
to supporting research to advance the understanding of all cancers,
including rare cancers, and to inform the development of targeted
cancer therapies for rare cancers and rare subtypes of cancers,
including pediatric cancers (all types and subtypes of pediatric
cancers are considered ``rare'' by definition).
The cancer research community--thanks to NIH-supported developments
in understanding the specific genes, proteins, and other unique
molecular characteristics driving certain cancer subtypes--continues to
recognize that cancer is made up of a collection of hundreds, if not
thousands, of subtypes defined by these characteristics. As a result of
National Cancer Institute (NCI)-supported efforts and other relevant
research, ``cancer'' is increasingly becoming a collection of rare
cancer subtypes.
This evolved understanding of cancer is reflected in NCI's current
clinical trials portfolio and investments in translational and basic
research, including several initiatives in the intramural Center for
Cancer Research (CCR).
Increasingly, clinical trials are examining targeted therapies
based on molecular subtypes. For example, NCI's National Clinical
Trials Network (NCTN) is currently supporting trials assessing
therapies to treat gliomas with certain genetic alterations \71\ and
pancreatic cancers with specific gene alterations.\72,73\ NCI also
supports trials that are dedicated to patients with rare tumors,
including the NCTN-supported Dual Anti-CTLA-4 and Anti-PD1-Blockade in
Rare Tumors (DART) Trial \74\ and the Rapid Analysis and Response
Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE
CANCER) Trial,\75\ which is supported by NCI's Experimental
Therapeutics Clinical Trials Network.
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\71\ www.clinicaltrials.gov/ct2/show/NCT00887146.
\72\ www.clinicaltrials.gov/ct2/show/NCT04858334.
\73\ www.clinicaltrials.gov/ct2/show/NCT04548752.
\74\ www.clinicaltrials.gov/ct2/show/NCT02834013.
\75\ www.clinicaltrials.gov/ct2/show/NCT04449549.
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To ensure that researchers have a strong pipeline of therapy
candidates to consider for use in clinical trials, NCI supports several
initiatives to support the preclinical stage of development of
therapeutics to treat rare cancers, including the NCI Experimental
Therapeutics (NeXT) Program and the Pediatric Preclinical Testing
Consortium (PPTC). The mission of NeXT is to advance clinical practice
and bring improved therapies to patients with cancer by supporting the
most promising new drug discovery and development projects. The PPTC
addresses key challenges associated with the development of new
therapies for children with cancer by developing reliable preclinical
testing data for pediatric drug candidates that can be used to inform
new agent prioritization decisions.
The first step in identifying new therapeutic targets, however, is
elucidating the basic biological mechanisms that give rise to cancers.
To further these research efforts, NCI supports the development of
resources for broad use across the cancer research community. These
resources include cell lines, organoid models, patient derived
xenograft (PDX) models, biospecimens, and other biological samples. NCI
makes drug information summaries available on its website, along with
extensive cancer treatment summaries. Additional resources include the
Developmental Therapeutics Program, the National Clinical Trials
Network (NCTN) Navigator, Patient-Derived Xenograft (PDX) Centers, PDX
Finder, the NCI Mouse Repository, and the Physician Data Query (PDQ)
Database.\76\
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\76\ A more extensive list is available at www.cancer.gov/research/
resources/.
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The Rare Tumor Patient Engagement Network, launched in fiscal year
2018 and part of NCI's CCR, leverages the resources of the NCI
intramural research program and the NIH Clinical Center to bring
together investigators, patients, and advocacy groups to study rare
tumors. Under the umbrella of this effort, NCI launched the My
Pediatric, Adolescent, and Adult Rare Tumor (MyPART) Network, a
collaboration of scientists, patients, family members, advocates, and
healthcare providers to find treatments for rare cancers. The MyPART
Network collects samples like blood, saliva, and archived biopsy tissue
from people with rare solid tumors as part of the Natural History Study
of Rare Solid Tumors. The purpose of the study is to engage rare tumor
patients and their families in the research process, study how rare
tumors grow, track participants' health history over a long period of
time, share data with other scientists, build new ways of testing new
treatments, and design new clinical trials for rare cancers. MyPART
scientists also hold clinics on rare tumors to facilitate
collaborations between researchers, patients, and advocacy
organizations; to date, MyPART has hosted clinics on chordomas, SDH-
deficient gastrointestinal stromal tumors, and medullary thyroid
cancer, and more clinics are in the planning stages. Additionally, the
NCI Comprehensive Oncology Network Evaluating Rare CNS Tumors (NCI-
CONNECT) program aims to advance the understanding of rare adult
central nervous system (CNS) cancers by establishing and fostering
patient-advocacy-provider partnerships and networks to improve
approaches to care and treatment; seven clinical studies and trials are
currently open through NCI-CONNECT.\77\
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\77\ www.cancer.gov/rare-brain-spine-tumor/refer-participate/
clinical-studies.
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Because of these and similar investments, the U.S. Food and Drug
Administration (FDA) has approved a number of therapies in recent years
for patients with rare cancer subtypes and related conditions. For
example, in May 2021, the FDA granted accelerated approval to sotorasib
(Lumakras) for patients with locally advanced or metastatic non-small
cell lung cancer (NSCLC) with alterations in the KRAS G12-C gene, a
mutation which is present in only 13.8 percentsa of NSCLC patients.
Similarly, the FDA approved selumetinib (Koselugo) in 2020 for the rare
tumor condition neurofibromatosis type 1, in patients over the age of
two, as the first approved treatment for this condition. In 2018, the
FDA granted accelerated approval to larotrectinib (Vitrakvi) for adult
and pediatric patients with solid tumors with a neurotrophic receptor
tyrosine kinase (NTRK) gene fusion. NTRK gene fusions are prevalent in
nearly all cases of certain rare cancer subtypes, including secretory
carcinoma of the breast or salivary gland and infantile fibrosarcoma;
they have also been observed in some patients with more common types of
cancer, such as glioma, melanoma, and carcinomas of the thyroid, lung,
and colon.\78\
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\78\ www.ncbi.nlm.nih.gov/pmc/articles/PMC6859817/.
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NIH will continue to support research efforts that reflect the
scientific understanding of the many subtypes of cancers, including
work that will enable the development of therapies for rare tumor
subtypes.
______
Questions Submitted to Dr. Gary Gibbons
Questions Submitted by Senator Roy Blunt
Question. Dr. Gibbons, we have all heard about the plight of COVID-
19 ``long-haulers'' who have symptoms after their acute COVID-19
infection has subsided. A growing number of studies suggest that many
patients experience some type of heart damage after contracting the
infection, even in those not sick enough to be hospitalized. According
to the American Heart Association, nearly one-fourth of those
hospitalized with COVID-19 have been diagnosed with cardiovascular
complications. A study in the Journal of the American Medical
Association stated that researchers found abnormalities in the hearts
of 79 percent of recovered patients and ``ongoing myocardial
inflammation'' in 60 percent.
Who is most at-risk of this type of heart damage, and is there
indication that this damage is permanent?
With heart damage appearing to be widespread, will screenings to
detect cardiovascular damage be included as routine follow-up care for
COVID-19 patients?
Do you have any sense of how long longitudinal studies should last
to follow long-haulers?
Answer. While severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) enters the body through the respiratory tract, the virus
also infects many other cell types and can damage multiple organs and
tissues, including the heart and blood vessels. In rare cases, acute
infection has been associated with cardiovascular complications
including acute myocardial injury, myocarditis (heart inflammation),
and arrhythmias (irregular heartbeat). This is not surprising given
that viruses frequently trigger inflammation, and as the body's immune
system fights off the virus, the inflammatory process can damage
healthy tissues, including the heart. Many different viruses are known
to cause myocardial injury and myocarditis.
Many patients with coronavirus disease 2019 (COVID-19) experience
damage to their blood vessels, leading to the formation of blood clots
(thrombosis) that can develop in or travel to vital organs, including
the heart. Blood clots in the coronary arteries can starve the heart of
oxygen and damage the heart muscle. NIH's ACTIV-4 Antithrombotics
adaptive master protocols have made progress in evaluating the safety
and effectiveness of various types of blood thinners (e.g., aspirin,
heparin, apixaban) for treating adults with signs of blood vessel
damage and thrombosis from COVID-19, known as COVID-19-associated
coagulopathy.\79\ Clinical trials are ongoing across three patient
populations (inpatient, outpatient, and convalescent or patients
recovering from COVID-19). These trials are providing valuable
information about how to help prevent moderately ill patients with
COVID-19 from progressing to intensive care, and could perhaps help
mitigate future cardiac complications. For example, ACTIV-4 has shown
that full-dose heparin is safe and effective at preventing blood clots
in moderately ill hospitalized patients and reduced the need for life
support.
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\79\ www.nih.gov/research-training/medical-research-initiatives/
activ/covid-19-therapeutics-prioritized-testing-clinical-trials#activ4.
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Studies have shown that patients with COVID-19 may show signs of
cardiac injury, detected by a release of the cardiac muscle protein
troponin into the bloodstream.\80\ Such injury is associated with worse
short-term outcomes and higher mortality. An analysis of more than 40
studies involving more than 8,000 COVID-19 patients found that venous
thromboembolism (VTE; blood clots originating in a vein) occurred in
approximately 21 percent of patients.\81\ Among COVID-19 patients
admitted to intensive care, the VTE rate was as high as 31 percent. A
review of myocarditis associated with acute COVID-19 estimated that the
incidence is less than five percent; although less than previously
thought, this could still mean a large number of patients with acute
myocarditis given that COVID-19 cases in the United States have
surpassed 33 million.
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\80\ www.heartrhythmjournal.com/article/S1547-5271(20)30625-1/
fulltext#tbl1.
\81\ pubmed.ncbi.nlm.nih.gov/33251499/.
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The incidence of continuing or new cardiac problems after COVID-19
or asymptomatic SARS-CoV-2 infection remains unknown. Although most
people with COVID-19 get better within weeks of illness, some people
experience post-acute sequelae, including chest pains, shortness of
breath, exhaustion, heart palpitations, and chest pain. In addition,
patients diagnosed with cardiac injury, thrombosis, or myocarditis
during acute COVID-19 could sustain damage to the heart that persists
long after the acute illness has passed. There is still much to be
learned about the long-term cardiovascular consequences of SARS-CoV-2
infection.
NIH's Researching COVID to Enhance Recovery (RECOVER) initiative
seeks to understand, and ultimately to prevent and treat, long COVID
and other post-acute sequelae of SARS-CoV-2 (PASC) across the
lifespan.\82\ At the center of the Initiative is an observational study
that will include adults and children recruited from ongoing studies of
COVID-19, long COVID clinics, and other cohorts. RECOVER is designed to
significantly expand both our knowledge about the full clinical
spectrum, long term outcomes, and underlying biology of PASC; as well
as our ability to provide safe and effective therapeutic interventions.
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\82\ recovercovid.org/.
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Current diagnostic protocols generally include physical, cognitive,
and psychological assessments. The evaluation of patients hospitalized
with COVID-19 includes elements of a cardiovascular evaluation,
including assessment of known cardiovascular disease and risk factors
for cardiovascular disease, assessment of symptoms that may be caused
by respiratory or cardiac disease, laboratory testing (including a
complete blood count and complete metabolic panel), chest radiograph,
electrocardiogram (ECG), and troponin testing (which is followed if
elevated). A more targeted cardiac evaluation may be needed depending
on the patient's symptoms. Patients who develop new onset heart
failure, for example, may need an echocardiogram (echo) to determine
the best course of action. One of the goals of the RECOVER meta-cohort
study is to develop core defining characteristics and diagnostic
criteria for long COVID and other forms of post-acute sequelae of SARS-
CoV-2 infection (PASC), including understanding the impact the virus
has on the cardiovascular system.
NIH plans to, and has support to follow the RECOVER meta-cohort for
at least 3 years. In addition to addressing the public health impact of
SARS-CoV-2 infection, RECOVER also has the potential to enhance our
understanding of other chronic syndromes theorized to have a viral
origin, at least in some individuals, such as chronic fatigue syndrome
and postural orthostatic tachycardia syndrome (POTS).
______
Questions Submitted by Senator Shelley Moore Capito
Question. Pulmonary fibrosis (PF) means scarring in the lungs. Over
time, the scar tissue can destroy the normal lung and make it hard for
oxygen to pass through the walls of the air sacs into the bloodstream.
PF is not just one disease--it is a group of more than 200 different
lung diseases that all look very much alike.
The most recent studies show that more than 200,000 Americans are
living with PF today. Approximately 50,000 new cases are diagnosed each
year and as many as 40,000 Americans die each year. With no known cure,
certain forms of PF, such as idiopathic pulmonary fibrosis, (IPF), may
take the lives of patients within three to 5 years from diagnosis.
PRECISIONS is the first-ever clinical trial to apply the principles
of precision medicine to the diagnosis and treatment of idiopathic
pulmonary fibrosis. PRECISIONS is supported by a $22 million grant from
the National Institutes of Health (NHLBI grant number HL145266) and
Three Lakes Foundation, a philanthropic organization.
PRECISIONS is designed as a double-blind, multi-center, randomized,
placebo-controlled trial investigating the safety and efficacy of NAC
in patients with IPF who have a specific genetic variant which is
present in 25 percent of IPF patients. The trial will enroll 200
patients from approximately 20 PFF Care Center Network (CCN) sites.
Initial recruitment into the study is being facilitated by looking at
phenotypic data from patients that are enrolled in the PFF Registry.
Can you provide an update on the NHLBI-funded PRECISIONS grant,
which seeks to shed more light on the role of genetics in pulmonary
fibrosis?
How has the COVID pandemic affected this study?
Answer. The National Heart, Lung, and Blood Institute (NHLBI) is
committed to supporting research on pulmonary fibrosis, which leads to
progressive scarring of the lungs that makes it increasingly more
difficult to breathe. PRECISIONS \83\ is a five-year study that aims to
enroll 200 patients with idiopathic pulmonary fibrosis (IPF) and use
genetic testing to identify those patients most likely to respond to an
experimental treatment, an antioxidant known as N-acetylcysteine or
NAC. This first-of-its-kind precision medicine trial builds on an
earlier study suggesting that a gene called TOLLIP influences how
patients respond to NAC, such that it might be helpful only for a
subgroup of patients who have a particular version of the gene. The
trial will enroll only that subgroup, in order to increase the
likelihood of detecting a benefit.
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\83\ reporter.nih.gov/project-details/9822535.
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PRECISIONS is co-funded by the Three Lakes Foundation, a non-profit
philanthropy that supports education and research efforts to improve
the time to diagnosis and accelerate new therapies for IPF. The study
also involves a partnership with the Pulmonary Fibrosis Foundation,
whose patient registry is being leveraged to perform molecular analyses
on biospecimens obtained from patients with IPF. These analyses are
intended to uncover novel genetic risk factors that will improve IPF
diagnosis, predict its clinical course, and understand its underlying
disease mechanisms--all of which could yield further insight into
potential targeted therapies.
The study was delayed in the latter half of fiscal year 2020 due to
COVID-19-related institutional research restrictions, which led to
NHLBI approval of a six-month interim no-cost extension. By December
2020, the investigators had successfully completed all pre-specified
project milestones for the first phase of their biphasic research plan,
including enrollment of the first study participant. NHLBI approved the
transition to the second phase of the project in March 2021. To date,
six study sites have been activated, the percentage of eligible
participants who meet the study's genotype inclusion criteria has been
exactly as expected, and recruitment has proceeded on target.
During COVID-19-related delays and uncertainty regarding the
feasibility of in-person lung function assessments (spirometry),
PRECISIONS initiated an ancillary study to understand the utility of
home spirometry to monitor patients with IPF. The study also intends to
add a COVID-19--specific questionnaire to baseline and follow-up visits
in the clinical trial as a means of leveraging this existing patient
cohort to capture additional data on the epidemiological and clinical
characteristics of COVID-19.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. Concerned about other countries' ability to obtain
vaccines quickly for their populations, the Administration recently
announced that it will support a waiver of the World Trade Organization
TRIPS Agreement, which would waive intellectual property protections
for COVID-19 vaccines. It is my understanding, however, that there are
no guarantees that the companies or countries who seek to use vaccine
manufacturer's intellectual property to make copies will be able to
deliver safe and effective vaccines, or that their manufacturing
processes will meet the strict regulatory standards necessary for
authorization. Furthermore, there are already reports of counterfeit
vaccines being used to exploit vulnerable populations in the U.S. and
around the world.
Are you concerned that giving away intellectual property via a
TRIPS waiver could make worse the problem of counterfeit and low-
quality vaccines in the market? What effect could this have on
endangering lives and undermining public confidence in the vaccines
that have been proven safe and effective?
Answer. The National Institutes of Health (NIH) is concerned about
counterfeit and low-quality vaccines; however, NIH does not have the
expertise or authority to investigate these matters. The degree to
which any TRIPS waiver addresses these issues of concern will not be
known unless and until the terms are agreed upon.
Question. The Administration recently endorsed the idea of waiving
intellectual property (IP) protections for COVID-19 vaccines, in the
hopes that it will speed up manufacturing of the vaccines around world.
However, it is my understanding that some vaccine developers are
already experiencing constraints in everything from raw materials to
fill-finish capacity critical to producing and administering vaccines.
Are you concerned that diverting critical supplies from
manufacturers with proven track records for delivering high-quality,
safe and effective vaccines could actually worsen the supply chain
constraints we're currently seeing, and not just for COVID vaccines,
but also non-COVID-19 medicines such as oncology and other infectious
diseases?
Answer. The National Institutes of Health (NIH) fully supports
efforts to ensure reliable supply chains for vaccines and other
medicines; however, NIH is not directly involved in these efforts.
______
Questions Submitted to Dr. Perez-Stable
Questions Submitted by Senator Roy Blunt
Question. Dr. Perez-Stable, we typically talk about getting
researchers into the NIH field and staying there as a pipeline.
However, when we look at the pipeline for minority researchers, it can
easily be called a funnel. We have a lot of work to do in increasing
the diversity of NIH researchers. And as the COVID-19 pandemic has
highlighted, NIH must also focus on health disparities research. The
problems to these two solutions may go hand-in-hand. I know that Dr.
Collins has started the UNITE program to look at racial inequities
within the NIH community and has started a Common Fund program to fund
transformative research into health disparities. While I commend these
steps, many of the fundamental issues these programs are trying to
address are reasons we started the Institute you fund--the National
Institute for Minority Health and Health Disparities.
Can you provide your perspective on how we get more minority
scientists into the NIH community?
And, specifically, what role should NIH take in making sure
minorities have the educational background necessary to go into STEM
fields--which often starts at the high school level, if not earlier?
Answer. The National Institutes of Health (NIH) is committed to
diversifying the research workforce and will continue to identify
opportunities to increase its focus on building and supporting a
diverse scientific workforce. The NIH UNITE initiative was developed to
address inequity in biomedical research and will help NIH to identify
more strategies and opportunities to strengthen its efforts to
diversify the research workforce and attract and prepare more students
from underrepresented backgrounds for STEM careers. The NIH already has
several efforts to diversify the STEM pipeline and to train students at
all levels of education as described below.
NIH supports several initiatives to attract and recruit more
minority scientists into the NIH intramural community. For example, the
NIH Equity Committee systematically tracks and evaluates diversity,
inclusion, and equity metrics in the intramural research program. In
addition, the Distinguished Scholars Program (DSP) enhances the
diversity of principal investigators in the NIH Intramural Research
Program (IRP) by supporting first year tenure-track investigators with
supplemental funds to start their research lab and engaging in
activities designed to foster a sense of belonging and to promote
research and career success. Moreover, the IRP provides a diverse
environment for NIH-wide scientific recruitments through the Stadtman
Tenure-Track Investigators, Lasker Clinical Research Scholars, and
Early Independent Scientists recruitment programs. This approach has
led to a greater proportion of women and scientists from
underrepresented backgrounds recruited to NIH. The 2019 DSP cohort was
comprised of approximately 7 percent Hispanics or Latinos, 27 percent
African Americans or Blacks, 27 percent Asians, 40 percent White, and
73 percent female. Among the fiscal year 2020 cohort, 21 percent was
African American or Black, 21 percent Hispanic or Latino, 21 percent
Asian, 36 percent White, and 50 percent female. Of the 15 Distinguished
Scholars selected in the 2019 cohort, nine were Stadtman Tenure-Track
Investigators, and two were Lasker Clinical Research Scholars. Of the
14 Distinguished Scholars selected in the 2020 cohort, 10 were Stadtman
Investigators, and three were Lasker Scholars.
Extramurally, NIH has dedicated efforts to recruit diverse
scientists from underrepresented groups to prepare successful NIH
grants. NIH provides Diversity Research Supplements to enhance the
diversity of the research workforce by recruiting and supporting
graduate students, post-doctoral fellows, and eligible investigators
from diverse backgrounds, including those from groups that have been
shown to be underrepresented in health-related research. These
supplements to existing grants provide a pathway to career success for
scientists from diverse backgrounds and remains relatively
underutilized. There are several other NIH programs that promote
diversifying the research workforce and some are highlighted below.
First, the NIH/National Institute on Minority Health and Health
Disparities Loan Repayment Program (NIMHD LRP), which aims to increase
the pool of qualified researchers who conduct health disparities
research. Over a 15-year period, recipients of an LRP award from NIMHD
are more likely to be awarded a subsequent NIH grant than their
counterparts who were not successful. The LRP Health Disparities
applications have now been extended to all NIH Institutes as of 2019.
Second, the Native American Research Centers for Health promote a cadre
of scientists and health research professionals interested in American
Indian/Alaska Native health research. Third, NIMHD established the
NIMHD Health Disparities Research Institute to support the research
career development of promising early-career minority health and health
disparities research scientists. Fourth, the NIH's Faculty
Institutional Recruitment for Sustainable Transformation (FIRST)
program, announced in 2020, will increase the participation of
researchers dedicated to inclusive excellence, including minority
researchers, in biomedical research at NIH-funded institutions. The aim
of the program is to enhance institutional inclusive excellence, with
diversity and equity at its core enabling biomedical research
institutions to hire a diverse cohort of early-stage research faculty
committed to inclusive excellence and diversity. The current pipeline
of underrepresented scientists is not empty with about 14 percent of
new U.S.-granted Science, Technology, Engineering and Math (STEM) PhDs
awarded to underrepresented groups and similarly 14 percent of current
medical students are from these groups.Lastly, the Science Education
Partnership Award (SEPA) Program funds innovative pre-kindergarten to
grade 12 science, technology, engineering, and mathematics (STEM) and
Informal Science Education (ISE) educational projects. SEPA projects
create partnerships among biomedical and clinical researchers and
teachers and schools, museums and science centers, media experts, and
other educational organizations. The NIH will continue to identify
opportunities to increase its focus on building and supporting a
diverse scientific workforce.
SUBCOMMITTEE RECESS
Senator Murray. The meeting is adjourned. Thank you.
[Whereupon, at 12:08 p.m., Wednesday, May 26, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]
DEPARTMENT OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2022
----------
WEDNESDAY, JUNE 9, 2021
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:02 a.m., in room SD-124, Dirksen
Senate Office Building, Hon. Patty Murray (chairwoman)
presiding.
Present: Senators Murray, Reed, Shaheen, Schatz, Baldwin,
Murphy, Manchin, Blunt, Capito, Hyde-Smith, Braun, and Leahy.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
STATEMENT OF HON. XAVIER BECERRA, SECRETARY
OPENING STATEMENT OF SENATOR PATTY MURRAY
Senator Murray. Good morning. The Senate Appropriations
Subcommittee on Labor, Health and Human Services, Education,
and Related Agencies will come to order. Today, we are having a
hearing on the Biden administration's fiscal year 2022 budget
request for the Department of Health and Human Services.
Senator Blunt and I will each have an opening statement, then I
will introduce our witness, Secretary Becerra. After his
testimony, Senators will each have 5 minutes for a round of
questions, and before we begin, I do want to walk through the
COVID-19 safety protocols in place today, and I want to thank
all of our clerks and everyone who has worked really hard to
get this set up and help everyone stay safe and healthy.
As I mentioned before the break, with the change in
guidance from the Office of the Attending Physician, the
committee is now returning to requiring in-person attendance by
witnesses and members who wish to make statements or ask
questions. However, social distancing remains in effect, and
those who have not been fully vaccinated are strongly
encouraged to wear masks.
While we are unable to have the hearing fully open to the
public or media for in-person attendance, live video is
available on our committee website, and if you are in need of
accommodations, including closed captioning, you can reach out
to the committee or the Office of Congressional Accessibility
Services.
Secretary Becerra, I am pleased to say this budget
represents a world of change from the past few years on
healthcare, and a road map on progress for years to come. It
proposes increasing the Centers for Disease Control and
Prevention's budget by nearly a quarter, which, as we discussed
in our hearings with Director Walensky, will not only help see
our Nation through this pandemic, but help us rebuild our
public health system, and better prepare for the next one.
It also proposes serious investments to tackle other
ongoing public health crises. Healthcare providers across my
State have reported a sharp uptick in youth mental health
emergencies during this pandemic, and the national suicide rate
has been climbing for years. This budget builds on the
resources we've provided for mental health and substance use
services in our COVID-19 bills with an additional $9.7 billion
for the Substance Abuse and Mental Health Services
Administration, and an increase of $3.7 billion over fiscal
year 2021 levels.
Washington State also saw drug overdoses increase by 38
percent over the first half of 2020, and our Nation saw a
record-breaking number of overdose deaths last year. President
Biden is proposing an historic investment of $10.7 billion
across HHS (Department of Health and Human Services) programs
to end the opioid epidemic, and he is proposing we continue the
progress we've seen towards ending another epidemic by
investing $670 million in the HIV/AIDS elimination initiative.
And to aid the fight against cancer, Alzheimer's, long-term
COVID-19, and countless other diseases, President Biden is
calling for the largest budget increase for the National
Institutes of Health in the agency's history.
In the fight against systemic racism, he has proposed new
investments across the department to reduce health disparities,
and after years of relentless attacks on women's healthcare and
reproductive rights, President Biden is charting a clear path
in a new direction, one that puts women's health first, and
puts patients, not politicians, in charge of their own
healthcare decisions.
I am pleased to see this budget call for $340 million for
the Title X Family Planning Program, which helps so many
patients, particularly women of color, get birth control,
cancer screening, STD screenings, and other essential care.
This funding will build on the administration's recent progress
to restore the Title X Family Planning Program with a new
proposed rule.
The budget would also eliminate the Hyde Amendment, which
is a critical step towards ensuring every person is trusted to
make their own individual choices about their life and future,
based on their own values, no matter who they are, where they
live, or how much money they make. I do recognize that is an
area of strong disagreement among members of this committee,
but for too long, Hyde has made abortion accessible only to
those with means, while women of color and women who are paid
low incomes struggle to get care.
This budget also takes other important steps to prioritize
women's health. Our maternal death rate is the highest in the
developed world, and two in three of those deaths is
preventable. The death rate for rural mothers is 50 percent
higher, and black and native women are two to three times more
likely to die from a pregnancy-related cause than white women.
This budget will invest $220 million to combat our maternal
mortality crisis.
Domestic violence is another longstanding and urgent
problem, and one made more challenging by a pandemic that makes
it even harder for people to get away from their abusers. This
budget proposes doubling Federal funding for programs that
provide shelter and support for survivors of domestic violence.
We've also seen throughout this pandemic how the childcare
crisis has grown worse, and been particularly hard on women,
and hardest of all on women of color, and women who are paid
low wages. This budget acknowledges the importance of investing
in a bright future for every child in our Nation, and proposes
to increase funding for childcare and development block grants
by $1.5 billion in addition to the bold investments proposed in
the American Families Plan, and provide an increase of over $1
billion for Head Start and pre-school development grants.
It also acknowledges our moral obligation to provide relief
to some of the world's most vulnerable populations, including
making sure the children in our Nation's custody are treated
with decency, humanity, and kindness by calling for $1 billion
in funding for refugee programs, and $3.3 billion for the
unaccompanied children program, which has been stretched thin
by this pandemic. These funds will help ensure children in HHS
custody are quickly and safely placed in appropriate homes,
provide care and services for them while they are in HHS
custody, and provide social and legal services after they leave
HHS custody.
Secretary Becerra, I look forward to hearing more from you
on how the department is prioritizing the health and well-being
of these children, and how this funding will help that work.
I always say a budget is a reflection of your values, and
all-in-all, this budget paints a clear, encouraging picture of
President Biden's values on healthcare. It shows he values
public health, science, equity, women, children, families, and
critically, the health and well-being of every single American,
and that he believes healthcare must truly be a right in this
country, not a privilege. I look forward to working with him
and Secretary Becerra and my Senate colleagues to pass
investments like those outlined in this budget into law to take
bold steps to lower healthcare costs, and expand coverage, and
apply lessons learned from the COVID-19 pandemic. With that, I
will turn it over to Senator Blunt for his remarks.
STATEMENT OF SENATOR ROY BLUNT
Senator Blunt. Thank you, Senator Murray. Appreciate
Secretary Becerra being here today. We spent several years
working together in the House before I came to the Senate, and
you went home to become the Attorney General of California, and
I look forward to what we can do together over the next couple
of years.
Certainly, over the past year, we've faced a global
pandemic that nobody would have anticipated, and nobody was
trained for. You said in the House hearing in May that the
fight against COVID-19 isn't over yet, and certainly, I agree
with that. While the vaccination rates are going up, and the
cases are going down, we still have a lot to finish to win this
fight.
Many public experts have stated, and that includes those
within the administration, that we really do have to achieve a
certain vaccination level necessary to reach the kind of
immunity where the virus ceases to spread, and we would hope,
when it had no opportunity to spread, it would then cease to be
something we need to be concerned about right now.
But we also are going to be looking carefully to see if a
booster is going to be required, and, of course, if a booster
is required to maintain that level of immunity, it's going to
be a great obligation on you, and the administration, and the
Congress to see that we have a plan that makes that work.
We also really need to have a clear strategy to provide
vaccines to developing nations. We've seen in the past that
outbreaks like Ebola, the one thing we know is that the next
sick patient is only a plane ride away from here, and so, what
we can do to help there ultimately protects us, as well.
I'm particularly concerned about what we're doing and the
strategy we have for unaccompanied alien children. You and I
have talked about that even yesterday, and I look forward to
chances to talk about that more. Many people think that this
unaccompanied children issue has nothing to do with COVID, but,
of course, how you deal with individuals coming in from another
country does have something to do with COVID, and it also has
something to do with COVID when you're taking money from our
COVID-19 funds to deal with this problem that has to be dealt
with.
So far, the department's transferred $2.98 billion to the
unaccompanied children account to deal with the fallout of
border policies that just simply aren't working. This includes
funding specifically that came out of COVID-19 relief, out of
the American Rescue Plan. I want to remind the committee than
only a few short months ago, President Biden felt it was so
imperative to pass a COVID-19 supplemental bill that the
administration pushed a $1.9 trillion bill through on a totally
partisan vote, with no real input from my side of the aisle,
and then, immediately, almost immediately, transferred $850
million of that funding that was going to go for COVID-19
relief to this fund for unaccompanied children.
Just last week, the administration transferred another $846
million to the unaccompanied children program from COVID-19
funding. That money in the bill was intended to fund community
health centers, behavioral health centers, workforce training,
public health workforce, and other programs. Well, you know, $3
billion of that money won't be allowed to do that because we're
having to deal with a policy at the border that has to be dealt
with, with even the vice president, in the last week, trying to
do things to tell people to stop coming to the border. We have
to have a policy that works better there.
The supplemental passed in December that was written by
this committee included, and it was a bipartisan vote, included
critical resources for the Strategic National Stockpile. We saw
the problems during the pandemic of what happened if the
Stockpile wasn't there. The department already has taken $850
million from the Stockpile fund to, again, the unaccompanied
children program. I will remind all of us that we've all had
questions over the last year of why didn't we do a better job
having the Stockpile money being used for the Stockpile. We
don't want to see the Stockpile again become a fund that is
easily transferred.
Finally, the department transferred $426 million from
fiscal year Labor/HHS funds for programs like--children's
hospitals, graduate medical education, the Ryan White HIV/AIDS
Program, medical research, childcare. One of the problems in
this last bill that was passed--I hope we don't repeat this in
a bill that comes through our committee.--I don't believe we
will, but unlike language we had normally had, there was no
real restraint on transfers, no restriction on those transfers,
no requirement to justify to the committee the transfers, no
notification of the transfers.
Those things were in every other bill we passed last year.
They were not in the first bill that was passed this year, and
so, the department hasn't given us notice on all of those
transfers in a timely way, but the bill didn't require them to
give us notice in a timely way. The members on my side of the
aisle want to have discussions about how we deal with this
ongoing in a better way.
Without a dialogue with this committee, I would hope again
that we don't have the flexibility next year that we have
insisted on, like reporting and things, in the past. While we
may disagree, and I may disagree with the Department's
transfers, or even the way the Unaccompanied Children Program
has been managed, there are certainly significant areas where I
do agree.
I support the National Institutes of Health increases. I
think the new research institute at NIH (National Institutes of
Health), ARPA-H (Advanced Research Projects Agency for Health),
is in the right place at the right time with the right focus,
and I announced in our hearing last week, you remember, Chair,
that I intend to be supportive of that, and I believe we can
make it work in a way we wouldn't have envisioned before the
last couple of years, and the new things we did to step up to
the pandemic.
I certainly agree with the expansion of the Certified
Community Behavioral Health Clinics to help address the mental
health crisis. I agree with efforts to end the HIV pandemic and
bring additional resources to bear on the opioid epidemic. The
devil's always in the details, but I hope we can move forward
on those things and others, but the administration is obviously
requesting a huge increase in nondefense discretionary funding.
In the Department of Health and Human Services alone, a 23
percent increase, or an increase of $23 billion. That's
compared to a defense department budget that the increase of
1.6 percent doesn't even keep up with inflation.
For the last several years, our friends on the other side
of this dais have pushed for parity between defense and
nondefense when Republicans were in charge and were advocating
defense spending. I hope we can have, and I expect, frankly,
will have a similar discussion this year.
Finally, I wholeheartedly disagree with the
administration's removal of the longstanding Hyde Amendment.
One of things I've had a chance to do in both House and Senate
is count, and I don't believe we can get a bill out of this
committee without having the Hyde Amendment in that bill. It's
been in the Appropriations Bill for 40 years. Every person on
this committee who has ever voted for a final Labor/HHS bill
has voted for Hyde since it first appeared in 1976. I don't
think this year should be or, frankly, at the end of the day,
will be different, but it is clearly, as the chair's already
pointed out, going to be an issue we're going to vigorously
discuss.
This committee, Mr. Secretary and Chair, have been
successful over the past 6 years with passing the bill, because
we've really done things that, while they move things in a
great direction, in the right direction, I think, didn't do it
in a way that made drastic policy changes. I look forward to
that same kind of incremental approach, and look forward to
working with you, Mr. Secretary, as we move forward to continue
to head your critically important department in the right
direction, because it serves the American people, and in many
ways, serves people all over the world. Thank you, Chairman.
[The statement follows:]
Prepared Statement of Senator Roy Blunt
Thank you, Chair Murray. I appreciate Secretary Becerra
(pronounced: ba-serra) for being here today to discuss the
Administration's fiscal year 2022 budget request.
Over the past year, we have faced the challenges of a global
pandemic. At a hearing in the House in May, you testified that, ``The
fight against COVID-19 is not yet over.'' I agree. While vaccination
rates are going up and cases are going down, we're still not finished
with the fight. First, as many public health experts have stated, even
those within the Administration, there is a certain vaccination level
necessary to reach herd immunity and we're not there quite yet. Second,
we may or may not need COVID-19 boosters at some point in the future
and if we do, that will require further outreach and vaccination
campaigns. Finally, we need to have a clear strategy to provide
vaccines to developing nations. As we have seen with past infectious
disease outbreaks like Ebola, the next sick patient is only a plane
ride away.
That is why I have been particularly concerned with the
Administration's strategy on Unaccompanied Alien Children. Many may
think that one issue has nothing to do with the other. But when the
Administration is robbing Peter to pay Paul, they become inextricably
linked.
Mr. Secretary, over the past three months the Department has
transferred $2.98 billion to the Unaccompanied Children account to deal
with the fallout of the Administration's failed border policies. This
includes funding specifically for COVID-19 relief from the American
Rescue Plan. I want to remind the Committee that only a few short
months ago, President Biden felt it was so imperative to pass a COVID-
19 supplemental bill that the Administration pushed through a $1.9
trillion partisan bill, with no input from Republicans, and then almost
immediately transferred $850 million from funding that should have gone
to additional COVID-19 testing to fund additional unlicensed shelter
beds for Unaccompanied Alien Children. And just last week, the
Administration transferred an additional $846.5 million to the
Unaccompanied Children program from their partisan COVID-19 bill
intended to fund Community Health Centers, behavioral health workforce
training, public health workforce, among other programs.
Second, the bipartisan COVID-19 supplemental passed in December
that was written by this Committee included critical resources for the
Strategic National Stockpile--which has proven essential during this
pandemic, and for future crises. The Department took $850 million from
this vital stockpile under the guise that the Unaccompanied Children
program needed money due to COVID-19 and not failed border policies.
Finally, the Department transferred $426 million from fiscal year
2021 Labor/HHS funds, from programs like Children's Hospitals Graduate
Medical Education, Ryan White HIV/AIDS, medical research, and child
care. Prior to making these choices, none of these decisions were
discussed with this Committee. In fact, Members on my side of the aisle
have had no substantive discussions with you about the crisis at the
border, even though the Administration has transferred or reprogrammed
almost $3 billion of funding to address it.
I understand that the Department is not in charge of our
immigration laws and that the Department has to care for unaccompanied
children that cross the border, regardless of where they come from or
how they arrive. But without a dialogue with this Committee on how to
do so, I suspect you will not have the flexibility to run this program
next year as you have had this year. The Appropriations Committee
appropriates funding based on the budget request, through arduous
negotiations between the Senate and House, between Republicans and
Democrats. I do not think the Administration should simply ignore that.
While we may disagree on the Department's management of the
Unaccompanied Children program, there are significant places where we
agree. I support the increase to the National Institutes of Health and
think that the new research Institute at NIH is coming at the right
time with the right focus. I agree with expansion of Certified
Community Behavioral Health Clinics to help address the mental health
crisis, efforts to end the HIV epidemic, and bringing additional
resources to bear to end the opioid epidemic.
However, this is going to be a difficult year and the devil is
always in the details. For example, the Administration is requesting a
15.9% increase for non-defense discretionary funding, and the
Department of Health and Human Services is requesting a 23% increase or
an increase of $23 billion. That is significant, especially when
compared to the Defense Department's budget request doesn't even keep
up with inflation. Over the last several years, the other side of the
aisle has pushed for parity between defense and non-defense funding and
that is where we have ended up. I would expect a similar outcome this
year.
Finally, I wholeheartedly disagree with the Administration's
removal of the longstanding Hyde Amendment. The Hyde Amendment prevents
the Department from using federal taxpayer dollars to fund elective
abortions. Hyde has been included in every government funding bill for
more than 40 years. Every person on this Committee who has ever voted
for a final Labor/HHS bill has voted for Hyde since its first
appearance in 1976. And I do not think this year should be any
different.
Mr. Secretary, this Committee has been successful over the last six
years with passing a bill because we haven't made fundamental, drastic
policy changes. That is the position I took as Chairman and it will
continue to be my position this year. I hope the Department will set
aside its partisan policies to support programs that benefit all
Americans instead.
Thank you, again, for being here today.
Senator Murray. Thank you very much, Senator Blunt. I will
now introduce our witness today. It's Xavier Becerra, the
Secretary of the Department of Health and Human Services. Thank
you for joining us today. And at this point, I'm going to turn
the gavel over to Senator Reed. Thank you for being here. I
have to go introduce three constituents at another committee
meeting. I will return, but until that time, Senator Reed will
hold the gavel, and Secretary Becerra, you can begin your
testimony. Thank you.
SUMMARY STATEMENT OF HON. XAVIER BECERRA
Secretary Becerra. Madam Chair, thank you. Ranking member
Blunt, members of the committee, thank you again. The
Department of Health and Human Services is at the center of
many challenges facing our country today. The COVID-19 pandemic
has shed light on how inequities and inefficient Federal
funding can leave communities vulnerable to crisis. Now, more
than ever, we must ensure that the Department has the resources
to achieve its mission, and to build a strong public health
system, and a healthier America.
For HHS, the budget proposes $131 billion in discretionary
budget authority, and $1.5 trillion in mandatory funding. This
budget underscores the administration's commitment to prepare
the Nation for the next public health crisis, to expand access
to affordable healthcare, to address health disparities, to
tackle the opioid and other drug crises, and to invest in other
priority areas, like maternal health, Tribal health, and early
childhood education.
We know the fight against COVID-19 is not yet over, but
even as HHS works to beat the pandemic, we must also prepare
for the next public health challenge. To start, the budget
makes significant investments in our preparedness and response
capabilities, including by investing in the Strategic National
Stockpile, and the public health workforce. It provides a new
mandatory funding stream for the manufacture of medical
countermeasures here at home, to protect Americans from future
pandemics, and create U.S. jobs.
The budget includes the largest fiscal year investment in
the CDC (Centers for Disease Control and Prevention) in almost
two decades. The budget reflects the president's commitment to
expand access to quality, affordable healthcare for all
Americans. It builds on the groundbreaking reforms introduced
in the American Rescue Plan by permanently extending the
enhanced premium subsidies that put affordable healthcare
coverage within reach for millions more Americans.
The budget also expands access to home and community-based
services under Medicaid, critical services that allow older
Americans and our loved ones with disabilities to live
independently in their homes and communities. And the budget
calls for Congress to take additional steps this year to lower
the costs of prescription drugs, and further expand and improve
health coverage through additional benefits and public coverage
options.
Healthcare must be a right, not a privilege, and I will
work hard to ensure that families across the Nation are able to
secure the healthcare that they need. And as we work to expand
access to affordable healthcare and address the challenges of
COVID-19 and future pandemics, we need to address public health
crises that are already here. Like violence in our communities
and climate change.
The President's budget increases funding to support
domestic violence survivors. It addresses gun violence by
doubling funding for firearm violence prevention research and
allows HHS to play a major role in the administration's
government-wide effort to tackle the climate crisis, by
supporting research and programs identifying the human health
impacts of the climate change and establishing an Office of
Climate Change and Health Equity.
To ensure that HHS is equitably serving all Americans, the
budget invests in reducing maternal mortality and morbidity
that disproportionately impacts women of color. It builds on
the American Rescue Plan's State option to extend Medicaid
postpartum coverage, it funds a range of rural healthcare
programs, and expands the pipeline for rural health providers.
It includes a dramatic funding increase in advance
appropriations for the Indian Health Services, and it invests
in improving access to vital reproductive and preventative care
services through Title X.
To support families and build the best possible future for
our children, the budget makes major investments to ensure high
quality childcare is affordable for low- and middle-income
families, and to provide high-quality pre-K for all 3- and 4-
year-olds. We know our experiences as children shape the adults
we become. Support in childhood leads to success in the future.
To address COVID-19's unprecedented acceleration of
substance use and mental health disorders, the budget makes
historic investments in SAMHSA (Substance Abuse and Mental
Health Services Administration) to support research,
prevention, treatment, and recovery services. To support
innovation in research, the budget increases funding for NIH by
$9 billion, $6.5 billion of which will go to establish the
advanced research project agency for health, ARPA-H, with an
initial focus on cancer and other diseases such as diabetes and
Alzheimer's.
This major investment in Federal research and development
will leverage ambitious ideas to build transformational
innovation through health research and the application and
implementation of health breakthroughs.
Finally, to ensure our funds are used appropriately, the
budget invests in program integrity, including efforts to
combat fraud, waste and abuse in Medicare, Medicaid, and
private insurance.
Madam Chair, I'd like--and Mr. Chairman, I'd like to close
by recognizing the women and men at HHS for their outstanding
and tireless work fighting COVID-19 to protect the health of
their fellow Americans. To build back a prosperous America, we
need a healthy America. We've taken important steps over the
past few months to expand access to quality, affordable
healthcare, to lower healthcare premiums, and to protect
women's health at home and abroad. President Biden's budget
request builds on that progress. Thank you.
[The statement follows:]
Prepared Statement of Hon. Xavier Becerra
Chair Murray, Ranking Member Blunt, and Members of the Committee,
thank you for the opportunity to discuss the President's Fiscal Year
(FY) 2022 Budget for the Department of Health and Human Services (HHS).
I am pleased to appear before you, and I look forward to continuing to
work with you.
HHS is at the center of many challenges facing our country today--
the COVID-19 pandemic, safely caring for unaccompanied children at our
southern border, the overdose and the addiction epidemic gun violence,
racial inequality, and more--and we are rising to meet those
challenges. I am honored to be given the responsibility to lead HHS at
this time.
COVID-19 has shed light on how health inequities and insufficient
Federal funding can leave communities vulnerable to crises. The
President's Budget invests in America, demonstrates a conscious effort
to address racial disparities in health care, tackles the opioid and
other drug crises, and puts us on a better footing to take on the next
public health crisis.
Now more than ever, we must ensure that HHS has the resources to
achieve its mission and tackle these challenges after years of
underfunding. The President has put forward a budget that does just
that. The FY 2022 budget proposes $131.8 billion in discretionary
budget authority and $1.5 trillion in mandatory funding. The Labor-HHS
total is $119.5 billion, an increase of $23 billion. Investments in the
budget support families in areas such as behavioral health (mental
health and substance use), maternal health, emerging health threats,
science, data and research, tribal health, early child care and
learning, and child welfare.
To build back a prosperous America, we need a healthy America, and
President Biden's budget builds on that vision while investing in the
many programs housed at HHS to save lives.
preparing for and responding to public health crises
The fight against COVID-19 is not yet over. Even as HHS works to
beat this pandemic, we are also preparing for the next public health
crisis. The FY 2022 budget makes significant investments in our
preparedness and response capabilities.
The Strategic National Stockpile, within the HHS Office of the
Assistant Secretary for Preparedness and Response, has served a
critical role in the COVID-19 response, permitting rapid deployment of
personal protective equipment, ventilators, and medical supplies to
states, cities, tribes, and territories across the country. The budget
provides $905 million for the stockpile, $200 million above FY 2021, to
ensure that the stockpile is ready to respond to future pandemic events
and any other public health threats while maintaining a robust
inventory of critical medical supplies, enhancing visibility of the
domestic supply chain, and modernizing the stockpile's distribution
model. In addition, the budget provides $823 million, $227 million
above FY 2021, for the Biomedical Advanced Research and Development
Authority, which has supported the development of new vaccines,
therapeutics, and diagnostics for the COVID-19 response. Additional
resources will support improved medical countermeasure platforms that
will enable quicker, more effective detection and public health and
medical responses to health security threats. The budget also supports
a strong public health workforce, and addresses gaps in the existing
public health infrastructure, including at the state and local levels.
In addition to discretionary investments, the budget includes $30
billion over four years in mandatory funding for HHS, the Department of
Defense, and the Department of Energy to protect Americans from future
pandemics and create U.S. jobs through major new investments in medical
countermeasures manufacturing; research and development; and related
biopreparedness and biosecurity investments.
During this pandemic, we have seen the critical role of the Centers
for Disease Control and Prevention (CDC). To ensure that CDC is well
positioned to address current and emerging public health threats, the
budget restores capacity to the world's preeminent public health agency
by investing an additional $1.6 billion over the FY 2021 level for a
discretionary funding total of $8.7 billion. This is the largest budget
authority increase for CDC in almost two decades. A core function of
CDC is partnering with state, tribal, local, and territorial entities,
and this funding will enhance those partnerships. The budget will also
provide CDC with additional resources to further develop and expand
teams of highly trained and deployable public health experts to support
preparedness at the local level.
The COVID-19 pandemic has also shown the importance of producing
reliable data. Bad inputs lead to bad outputs, and without good data,
CDC cannot effectively prepare for, or respond to, public health
threats and make well-informed decisions to protect the American
people. With funding provided in the FY 2022 budget, CDC will build
upon previous investments in the data infrastructure to date and
continue efforts to modernize public health data collection and
analysis nationwide.
Public health threats know no borders, and CDC is working to
prevent, detect, and respond to epidemic threats at home and abroad.
With CDC experts embedded in countries around the world, CDC is
supporting global COVID-19 response by leveraging core public health
capacities and relationships built through decades of CDC global health
activities. As we continue to confront new and emerging COVID-19
variants, as well as a surge of cases in India, support for CDC's work
is even more important. CDC is working closely with U.S. government
agencies, ministries of health, and other partners to assist countries
in responding to COVID-19, while simultaneously developing and
implementing adaptations to interventions for malaria, HIV, and
vaccine-preventable diseases. With the President's proposed FY 2022
investments, CDC will not only address preparedness within the United
States, but will also support core public health capacity improvements
overseas and strengthen global health security by improving our ability
to deploy experts internationally and support efforts to prevent,
detect, and respond to emerging global biological threats. CDC will
invest in global health security and continue to fight health threats
worldwide while simultaneously enhancing domestic preparedness to
address threats here at home. Domestic health is increasingly impacted
by global factors and CDC's global health security efforts include
conducting research to ensure efficient disease response.
The Assistant Secretary for Preparedness and Response (ASPR) and
CDC investments complement preparedness activities across HHS including
basic and clinical research within National Institutes of Health (NIH)
and activities within the Food and Drug Administration (FDA) to advance
regulatory science and mitigate potential supply or drug shortages.
While we prepare for future pandemic threats, we are also facing a
public health crisis that is already here: violence in our communities.
The current public health emergency has shone a light on the issue of
domestic and gender-based violence. More than 1 in 4 women and more
than 1 in 10 men have experienced contact sexual violence, physical
violence, or stalking by an intimate partner and reported significant
impacts. The budget provides $489 million for the Administration for
Children and Families (ACF) to support and protect domestic violence
survivors, which is more than double the FY 2021 enacted levels. The
budget also provides $66 million for victims of human trafficking and
survivors of torture, more than 45 percent above FY 2021 enacted
levels.
We have also seen the devastating impact of gun violence in
communities across the country. Almost 40,000 people die as a result of
firearm injuries in the United States every year, while homicide is the
third leading cause of death for people ages 10-24. This is a public
health issue, and one that disproportionately impacts communities of
color. The budget addresses this crisis by doubling CDC and NIH funding
for firearm violence prevention research. The budget provides $100
million in discretionary funding to CDC to start a new Community
Violence Intervention initiative, in collaboration with the Department
of Justice, to implement evidence- based community violence
interventions at the local level. In addition to the discretionary
investment for the Community Violence Intervention initiative, the
budget includes a total of $5 billion in mandatory funding for CDC and
the Department of Justice, beginning in FY 2023 and continuing through
FY 2029.
The climate crisis has real public health impacts, and the HHS'
mission depends on healthy and sustainable environments. HHS thus has a
major role to play in the Administration's government-wide effort to
tackle this crisis. HHS' investments to combat climate change in the FY
2022 Budget will advance health equity, lay the foundations for
economic growth, and ensure that benefits from tackling the climate
crisis accrue to tribal communities, communities of color, low-income
households, and disadvantaged communities that have been marginalized
or overburdened. The budget includes a $100 million increase in NIH
funding to support research aimed at understanding the health impacts
of climate change, as well as an additional $100 million investment in
CDC's Climate and Health program to support efforts to understand and
identify potential health effects, including children's environmental
health considerations associated with climate change and implement
plans to adapt to a changing environment. The American Jobs Plan also
would invest $1.5 billion to increase the resilience of hospitals and
critical infrastructure, fund health emergency preparedness cooperative
agreements, and build resilience including in relation to the effects
of a changing climate.
caring for all americans through health and human services
Central to the HHS mission is the charge to enhance the health and
well-being of all Americans. The budget invests in areas across HHS to
ensure that we are equitably serving the American people. As Secretary,
I will ensure that this focus is fundamental to all of our work.
A critical part of this is investing in civil rights enforcement to
ensure that all people receiving services from HHS-conducted or HHS-
funded programs, no matter who they are, or where they live, can
receive health care free from discrimination.
The FY 2022 Budget makes expanding affordable health care access a
priority across Centers for Medicare & Medicaid Services programs. A
recently released report titled ``Health Coverage Under the Affordable
Care Act: Enrollment Trends and State Estimates'' shows that the
Affordable Care Act (ACA) has expanded health insurance coverage to
millions of Americans, and the budget goes even further. It builds on
the groundbreaking reforms introduced in the American Rescue Plan Act
by extending the enhanced premium subsidies that put affordable health
care coverage within reach of millions more Americans. These
improvements in the American Rescue Plan Act are lowering premiums for
more than nine million current enrollees by an average of $50 per
person per month. In addition, due to the COVID-19 pandemic, an ongoing
opportunity to apply for enrollment in Marketplace health care coverage
is available on HealthCare.gov through August 15. This extension
provides individuals and families a desperately needed opportunity to
get quality, affordable health insurance coverage. As of May 10, over 1
million additional Americans have signed up for health insurance
through the Marketplace, and an additional 2 million obtained improved
benefits through the Marketplace, benefitting from both reduced
premiums and more affordable cost sharing.
The FY 2022 Budget also expands access to critical home- and
community-based services (HCBS) under Medicaid, critical health care
services that allow older people and people with disabilities to live
independently in their homes and communities. The budget builds on the
additional Medicaid funding included in the American Rescue Plan that
not only expands access to these important services but also
strengthens state HCBS programs by allowing states to use the
additional money to, for example, provide additional benefits, like
mental health and substance use services, to beneficiaries, as well as
to raise wages and provide paid leave for home care workers.
I look forward to working with the Congress to achieve the
Administration's goal of lower costs and expanded and improved coverage
for all Americans. This includes reforms to lower the costs of
prescription drugs, such as allowing Medicare to negotiate payment for
certain high-cost drugs, and requiring manufacturers to pay rebates
when drug prices rise faster than inflation. We will also work to
improve Medicare, Medicaid, CHIP, and private insurance coverage, by
pursuing changes such as improving access to dental, hearing, and
vision coverage in Medicare, making it easier for eligible people to
get and stay covered in Medicaid, promoting Early and Periodic
Screening, Diagnostic and Treatment (EPSDT) requirements for eligible
youth, and reducing out-of-pocket costs for individuals in private
insurance coverage obtained through the Marketplace. The Administration
also supports additional public coverage options, including a public
option that would be available through the insurance marketplaces.
Health care is a right, not a privilege, and I will work to ensure that
families across the nation are able to secure this right.
The United States has the highest maternal mortality rate among
developed nations, with an unacceptably high mortality rate for Black
and American Indian/Alaska Native women. Addressing this critical
public health issue is a major priority of this Administration, as
evidenced by the American Rescue Plan's state option to extend Medicaid
postpartum coverage. Building on HHS's longstanding efforts to improve
maternal health, including the Department's recent Medicaid postpartum
waiver approvals, the budget provides more than $220 million in
discretionary funding to reduce maternal mortality and morbidity by
implementing evidence-based interventions to address critical gaps in
maternity care service delivery and improve maternal health outcomes.
This includes increased funding to CDC's Maternal Mortality Review
Committees and the Health Resources and Services Administration's
(HRSA) Rural Maternity and Obstetrics Management Strategies program.
HRSA also prioritizes maternal health through its Title V Maternal and
Child Health Block Grant and Alliance for Innovation on Maternal Health
programs. As with all our public health work, collecting good data will
be critical. In addition to these discretionary resources, the budget
includes $3 billion in mandatory funding over five years, to invest in
maternal health and reduce the maternal mortality rate and end race-
based disparities in maternal mortality.
HRSA's work is central to our focus on serving all Americans, given
their mission to improve health outcomes and address health
disparities. HRSA-funded Health Centers provide access to care for low-
income and marginalized populations, and they serve 1 in 11 people in
the nation. The President's Budget increase to workforce diversity
programs, highlights HRSA's commitment to supporting health care
providers dedicated to working in underserved areas and building toward
a workforce that reflects the communities it serves and is able to
provide culturally relevant care.
The budget provides $670 million across HHS to continue efforts to
end the HIV epidemic in the United States by working closely with
communities that have high rates of HIV transmission to implement
effective prevention, diagnosis, and treatment strategies, including
ones that address the disproportionate impact of HIV and Hepatitis C
infections in Tribal communities. HHS programs have already made major
progress in combating the HIV epidemic. HRSA ensures equitable access
to services and supports for low-income people with HIV through Health
Centers as well as the Ryan White HIV/AIDS Program. In 2019, 88.1
percent of those served under the Ryan White HIV/AIDS Program had
achieved viral suppression, a record level that exceeds the national
average of 64.7 percent. HHS will build on this work to end the
epidemic once and for all.
Also, directly connected to the HHS mission is the need to provide
access to high-quality care, no matter where you live. HHS will
continue to focus on the unique needs of rural communities. HHS
administers a range of programs that address rural health, from those
that serve large populations such as Health Centers, to those serving
targeted populations such as the Black Lung Clinics Program. The FY
2022 budget serves active, inactive, retired, and disabled coal miners
and their families through high-quality medical, outreach, educational,
and benefits counseling services. It also provides funding to increase
the number of individuals receiving training and serving in health
professions in rural communities, as research has shown that providers
are likely to remain in the communities where they train as residents.
HHS will also address the stark health disparities that persist in
Tribal communities by investing in the Indian Health Service (IHS),
which serves over 2.6 million American Indians and Alaska Natives. The
COVID-19 pandemic's devastating impact on Tribal communities has
demonstrated the real human toll of these disparities. The budget
provides a $2.2 billion, or 36 percent, increase for IHS in order to
take a historic step to address chronic underfunding, expand access to
high-quality health care, and address critical facilities and
information technology infrastructure deficiencies across Indian
Country. For the first time, the budget also proposes advance
appropriations for IHS to provide stability for the Indian Health
system and parity with how other Federal health agencies are funded. I
am committed to strengthening the Nation-to-Nation relationship between
the United States and Indian Tribes. To this end, the budget supports
self-determination through a consultative process to consider long-term
solutions, including mandatory funding, to ensure adequate and stable
funding for IHS.
The budget also provides an 18.7 percent increase to the Title X
Family Planning program to improve access to vital reproductive and
preventive care and to advance gender equity. Over the last two years,
nearly half of the programs supported by Title X lost providers as a
result of the 2019 regulation which added burdensome restrictions
inconsistent with quality care guidelines and ultimately resulted in
many highly qualified, longstanding healthcare entities to exit Title
X. The budget allows Title X to not only restore highly qualified
providers, but also to expand its essential services to meet increased
demand as a result of the global pandemic and resulting recession. In
2019, Title X-funded clinics served almost 3.1 million Americans, 66
percent of whom had incomes at or below the federal poverty level and
41 percent of whom were uninsured. This is nearly 1 million fewer
people served than in 2018.
investing in children's futures
Our experiences as children shape the adults we become, and support
in childhood can mean success in the future. As Frederick Douglass
wrote, ``It is easier to build strong children than to repair broken
men.'' High-quality early care and education lay a strong foundation so
that children can take full advantage of education and training
opportunities later in life. The American Jobs Plan and the American
Families Plan invest in school and child care infrastructure and
workforce training, and ensure that low and middle-income families pay
no more than 7 percent of their income on high-quality child care.
These investments include $200 billion over ten years for a national
partnership with states to offer free, high-quality, accessible, and
inclusive preschool to all three- and four-year-olds, benefitting five
million children. The budget also invests $250 billion over ten years
to make child care affordable.
The budget also provides $19.8 billion in discretionary funding for
the Department's early care and education programs in ACF, $2.8 billion
over FY 2021 enacted. This includes $11.9 billion for Head Start, which
helps young children enter kindergarten ready to learn. Head Start
programs deliver services through 1,600 agencies in local communities,
and they provide services to more than a million children and pregnant
women every year, in every U.S. state and territory. In addition, the
budget provides $7.4 billion for the Child Care and Development Block
Grant, $1.5 billion over FY 2021 enacted, to expand access to high-
quality child care for families in all corners of the country. Over a
million children receive child care subsidies every month funded by the
Child Care and Development Fund, and nearly half of the families
receiving child care subsidies reported income below the Federal
Poverty Level. These investments will improve outcomes for children
across the country.
The budget also invests in improvements to the child welfare
system, particularly to address its racial inequity. The budget
provides $100 million in new competitive grants for states and
localities to advance reforms that would reduce the overrepresentation
of children and families of color in the child welfare system and
address the disparate experiences and outcomes of these families. This
funding will also give more families the support they need to remain
safely together. The budget also provides $200 million for states and
community-based organizations to respond to, and prevent, child abuse,
over 30 percent above FY 2021 enacted.
combating mental health and substance use crises
HHS must address the public health crises associated with mental
health and substance use disorders. This need is especially urgent
given that both crises have accelerated during the COVID-19 pandemic.
Calls to mental health helplines have increased across the country as
Americans struggle with increased anxiety, depression, risk of suicide,
and trauma-related disorders resulting from the pandemic. Younger
adults, racial minorities, essential workers, and unpaid adult
caregivers are particularly impacted. Similarly, preliminary data from
2020 suggests that overdose deaths, which were already increasing,
accelerated at an unprecedented rate during the pandemic. Provisional
data suggest that over 90,000 drug overdose deaths occurred in the
United States in the 12 months ending in September 2020. That
represents a year-over-year increase of close to 29 percent.\1\ This
crisis is also evolving--overdose deaths involving substances other
than opioids are also increasing. HHS will ensure that our work is
responsive to the needs of communities across the country.
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\1\ Centers for Disease Control and Prevention. (2021). Vital
Statistics Rapid Release: Provisional Drug Overdose Death Counts.
Retrieved May 6, 2021 at https://www.cdc.gov/nchs/nvss/vsrr/drug-
overdose-data.htm.
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The budget addresses these crises through investments in the
Substance Abuse and Mental Health Services Administration.
In a historic investment, the budget provides $1.6 billion to the
Community Mental Health Services Block Grant to respond to the systemic
strain on our country's mental health care system--more than double the
FY 2021 level. To address the undeniable connection between the
criminal justice system and mental health, the discretionary request
will also invest in programs for people involved in the criminal
justice system. HHS will also focus on the behavioral impact of COVID-
19, including on children. When children and young people face Adverse
Childhood Experiences (ACEs) such as trauma, it can continue to affect
them across their lifespan, so it is critical we intervene now to
support their social, emotional, and mental well-being.
The budget also takes action to address addiction and the overdose
epidemic, investing $11.2 billion across HHS, $3.9 billion more than in
FY 2021, including $3.5 billion for the Substance Abuse Prevention and
Treatment Block Grant, which has historically failed to keep up with
increases in the cost of providing substance use care to America's
neediest citizens. For the first time, the budget includes a 10 percent
set aside for recovery support services, a critical step for building
and sustaining the nation's recovery support services infrastructure.
The Block Grant remains a critical source of funding for states,
tribes, and territories to provide prevention, treatment, and recovery
support services to their citizens. The impact of this epidemic is felt
in our communities, and the budget will direct funding to states and
Tribes to increase community-level response. The budget will also
increase access to medications for opioid use disorder and expand the
behavioral health provider workforce, particularly in underserved
areas. I greatly appreciate the investments the American Rescue Plan
Act provided to the Substance Abuse Prevention and Treatment Block
Grant, Mental Health Block Grant, and Certified Community Behavioral
Health Centers, and HHS will continue to build on these efforts.
promoting biomedical research
HHS' work is responsible for major scientific breakthroughs, and we
are committed to supporting innovative science and research in order to
advance the health and well-being of our nation. As the world's premier
biomedical research agency, NIH will continue to be at the forefront of
scientific advancements. The budget includes $52 billion for NIH, a $9
billion increase or 21 percent increase over FY 2021 enacted. Included
in this increase is $6.5 billion to establish the Advanced Research
Projects Agency for Health (ARPA-H). With an initial focus on cancer
and other diseases such as diabetes and Alzheimer's, this major
investment in Federal research and development will leverage ambitious
ideas to build transformational platforms, capabilities, and resources
to speed the application and implementation of health breakthroughs and
shape the future of health and medicine in the U.S.
This bold new approach will complement NIH's existing research
portfolio, which is a vital contributor to longer and healthier lives,
supports and trains world-class scientists, and drives economic growth.
Outside of ARPA-H, the remaining $2.5 billion increase will allow NIH
to continue investing in basic research and translating research into
clinical practice to address the most urgent challenges, such as HIV/
AIDS and ending the opioid crisis.
restoring america's promise to refugees
HHS plays a critical role in promoting the wellbeing of those
seeking refuge or relief in the U.S. The FY 2022 budget provides over
$4.4 billion to the Office of Refugee Resettlement (ORR)--an increase
of over $2.5 billion above FY 2021 enacted. This funding would allow
ORR to support an increase in the refugee admissions ceiling to 62,500
this fiscal year and to continue to rebuild the resettlement
infrastructure in order to resettle up to 125,000 refugees in FY 2022.
This funding increase also reflects a commitment to ensuring that
unaccompanied children are provided with care and services that align
with child welfare best practices while they are in ORR's custody, and
unified with relatives and sponsors as safely and quickly as possible.
Despite significant challenges posed by COVID-19 and policies from the
previous administration, HHS is humanely caring for unaccompanied
children while working to unite them with a vetted sponsor. Working
across government and in close partnership with the Department of
Homeland Security, we have substantially increased our ability to
quickly facilitate the transfer of children out of U.S. Customs and
Border Patrol custody and into child-appropriate settings, including
with fully vetted sponsors.
funding core program operations
It is simply not possible to meet the HHS mission and address all
these key changes without sufficient funding to cover our operational
needs. The FY 2022 budget invests to bolster operations. It strengthens
administrative and operational resources throughout the Department
needed to ensure proper stewardship of resources entrusted to HHS by
Congress.
providing oversight and program integrity
Given the magnitude of HHS's work-and the taxpayer dollars used to
fund it-it is critical that we ensure that our funds are used
appropriately. The budget invests in program integrity, including
efforts to combat fraud, waste, and abuse in Medicare, Medicaid, and
Private Insurance.
conclusion
I want to thank the Committee again for inviting me to discuss the
President's FY 2022 Budget for HHS, which offers a comprehensive fiscal
vision for the nation that reinvests in America's health, supports
future growth and prosperity, and meets U.S. commitments in a fiscally
sustainable way. I look forward to continuing to show how HHS helps
fulfill that vision.
Senator Reed [presiding]. Thank you very much, Mr.
Secretary. Chairwoman Murray has allowed me to go first, and
then I'll recognize Senator Blunt. Like Senator Blunt, one of
the privileges of my life in public service is having served
with you in the House of Representatives, and congratulations,
Mr. Secretary, on your well-deserved position.
NATIONAL SUICIDE PREVENTION LIFELINE
One of the legislative initiatives that I was involved with
was the National Suicide Prevention Lifeline. I worked together
with Senators Gardner, Baldwin, and Moran. We've changed the
ten-digit number to a three-digit number, and several States
have already adopted the number. Everyone has to adopt it by
next year, but the reality is we'll need more funding, because,
as more people use this number, we'll need more counselors and
more capacity.
We asked that SAMHSA provide a cost estimate to Congress on
Lifeline in early April. Could you give us an update on the
cost estimate, Mr. Secretary?
Secretary Becerra. Senator, thank you for the question,
because this one is important. Even though it's not one of the
bigger items, it is crucial for a lot of people. Just as 911
has become indispensable, 988, I believe, will become
indispensable for those who need some help in crisis.
And where we are right now, Senator, is we have had some
briefings with members on the Hill. We're trying to follow up
with those. We're hoping to move as quickly as possible. You
may have seen in the budget, the President has quadrupled the
amount of money that he would allocate for this particular 988
program and so, we would hope to receive funding for--about a
year's worth of funding of about $102 million over the 24 or so
million that there was before.
We're hoping to move quickly, but I think you're right. To
do this well, and to do it throughout the country, we may need
to come back to you.
Senator Reed. Well, thank you, Mr. Secretary, but I think
we all recognize there's been an incredible increase in
suicides, and particularly disturbing, among young people, also
among service members, and so, I appreciate your efforts to get
this thing done.
LOW INCOME HOME ENERGY ASSISTANCE PROGRAM
Turning to another issue, LIHEAP (Low Income Home Energy
Assistance Program). It's a critical program, long supportive
of it. The resources in the budget are impressive, and I
appreciate it, but one of the issues we have is getting the
word out, if you will. There are many individuals who could
participate, but they're not aware of the program. Can you
share the steps the agency is taking to conduct outreach and
make sure that eligible individuals get their LIHEAP?
Secretary Becerra. Senator, on top of increasing the budget
for the LIHEAP program, because, like you, I have been a
fighter for this program for quite some time, and we're also
reaching out. We're reaching out to the utility companies,
we're reaching out to local governments, we're trying to have
them help us reach out to people who qualify for these
services, and so, we don't want to just wait and believe that
people will hear that we're increasing the funding for LIHEAP.
We're going to try to work with our local partners, private
sector and public, to try to reach those families that really
need this funding to help them survive, and make sure, monthly-
wise they're covered.
Senator Reed. Well, thank you, Mr. Secretary. One of the
agencies that has been very effective are the community action
agencies. They have roots in the community, so, I'm sure
they're on your list, but I just wanted to mention that for the
record.
PERSONAL PROTECTIVE EQUIPMENT MANUFACTURERS
We all are concerned about PPE (Personal Protective
Equipment). We had a wake-up call during the pandemic, and we
are concerned about how you're stockpiling it in terms of
prioritizing U.S. manufacturers, or at least manufacturers that
are consistent allies of the United States, and not potential
competitors. But can you comment?
Secretary Becerra. Here I have to thank you all for the
work you did to help us stand up a sizeable pot of money, $10
billion, that will help us make sure that we're doing all we
can to increase domestic manufacturing of that. Not just the
PPE, but the types of material, and the types of product that
we need in the event of a future pandemic, or a future crisis.
And so, we're trying to adapt. The stockpile has to enter
the 21st century. We have to make sure that what we do have
stored actually will work once we need it, and we have to make
sure that what we are storing is what we need to be equipped
for the crises of the 21st century. But thank you for that
support.
Senator Reed. Well, thank you very much, Mr. Secretary, and
again, thank you for your service, and I'm extremely pleased
that you're the Secretary. Thank you.
Secretary Becerra. Thank you, Senator.
Senator Reed. Senator Blunt, please.
Senator Blunt. Thank you, Senator. Secretary, the Congress
has provided $178 billion over the course of the last year for
the Provider Relief Fund. There's another $8.5 billion in
addition to that for rural hospitals in the American Rescue
Plan that passed in January. I think most of that money has to
be spent by June 30.
You answered some questions on that at the Ways and Means
Hearing yesterday. You said we're trying to make sure we don't
make the mistakes of the past. What are a couple of those
mistakes, and how are you trying to move forward without
continuing what you think was a mistake?
Secretary Becerra. Senator, I think we would all agree that
we want to know where and why taxpayer dollars are going to
particular item or cause, and I think most people will tell
you--at least the comments that we're seeing are that there
wasn't enough transparency in the process. How the money was
allocated. Why was one provider provided dollars, in some
cases, quite a bit of money, and in other cases, other
providers who were also in need, didn't?
And so, what we want to do is provide that transparency. At
the same time, we understand that there were a number of
providers who were left behind because of the formula that was
used to disperse the dollars, based on Medicare claims.
And in many cases, if you happened to be a provider that
relied a lot on, say, Medicaid or other sources, or you
provided a lot of charity care, you might not have had the same
level of claims. That doesn't mean you didn't have the COVID
patients. So, we're trying to provide the transparency, make
sure we direct the money where it's needed, and with the money
that's still left, we want to make sure that you all can look
at this and say, we get it.
Senator Blunt. So, I think there's approximately $50
billion left. I also believe that money, most of it, needs to
be spent by June 30. What are you doing to get that money out,
and when you do get it out, what are you doing to make it more
likely that the hospitals will be able to spend that money
before the deadline?
Secretary Becerra. Senator, there's a tranche of money that
has not yet been allocated, and so the deadline for spending
that has not yet been determined, but there is money that did
go out that does have a deadline, and what we're trying to do
is, over the next few weeks, make sure we provide some guidance
so people understand how we can make sure that everyone
fulfills their commitments in getting these dollars.
We want to make sure we provide some flexibility. We also
want accountability. We want to make sure folks understand that
when they got these taxpayers dollars to help Americans in
need, that taxpayers expect that it went to help those families
in need. And so, what we'll try to do is--understand that we
can't change the process that began before, but what we can try
to do is make sure we get the accountability while trying to
provide some flexibility.
Senator Blunt. So, advice I gave the previous
administration on this in a letter I wrote last fall was, don't
make it needlessly difficult by continuing to change the
guidelines that you've giving hospitals on how they can spend
the money. So, I hope as you allocate this last amount of
money, or put out whatever guidance you need, that it doesn't
suddenly restrict what they were earlier told they could do,
but more importantly, it does let them know that you're going
to have guidelines out there that they can rely on if they
spend the money that way, that it meets the guidelines.
UNACCOMPANIED CHILDREN
On the unaccompanied children issue, Secretary, I think you
have an average of about 400 children coming in every day. You
can verify that, if you know, and how many children do you have
leaving the program every day?
Secretary Becerra. It's a number, Senator, as you know,
that fluctuates. A couple months ago, the average was probably
closer to 600, maybe above that. Today, you're probably right.
It hovers somewhere between 3 to 5 hundred a day, but we can't
predict it.
Senator Blunt. Well, the average is kind of what I'm
wondering about, both on children coming in and then children
leaving the program.
Secretary Becerra. Yes, again, right now, and what we do at
the department, my team, we try to use a week average. We go
week by week to see the trends, but I'd say you're probably
accurate. Somewhere between 3 to 5 hundred a day, over the last
week, two weeks coming in.
Those that we are discharging to a responsible sponsor,
after checking the background of those individuals, somewhere
between, probably between 4 to 6 hundred, probably closer to
the higher range of 600 than 400.
Senator Blunt. And who checks the background on the
individuals that these children are given responsibility for?
Secretary Becerra. We have a dedicated team of people
who've been trained to do background checks.
Senator Blunt. And they work for you? HHS team, or a----
Secretary Becerra. It's an HHS team. We pay for all the
services that are provided. In many cases, we've been
fortunate, the Department of Homeland Security has been very
generous in providing us with some of their personnel who have
been trained in doing intake work and processing. We have
others within the Federal Government who have volunteered, and
certainly we have folks from within HHS who are doing this.
We had to substantially increase the number of caseworkers
that we use so we could make sure we process in a timely
fashion those children's record to see if they could be
discharged to a responsible custodian.
Senator Blunt. Well, when 400 are coming in, or 500 or
coming in, but more importantly, when say, 500-600 are going
out, I know you don't want, and I don't want any of those
children to go to a place where they're less safe, where
they're going to be exploited or taken advantage of, and I
would hope you're doing everything you can dealing with those
big numbers to be sure that that does not happen.
Secretary Becerra. Senator, I can assure you, the reason
back in March and April we were looking at this and really
seeing it as a major challenge in CBP, that's Customs and
Border Protection, was having these large number of children in
their adult detention facilities, where they should not be, is
because we wanted to make sure before we took that child, we
could provide exactly what you just said.
The safety, the health requirements, wherever we are going
to place that child. We ran out of the licensed care facilities
that we typically would send these kids to a substantial time
ago. We've had to stand up a number of emergency shelters to be
able to properly house these children, and where possible, we
try to move them as quickly as we can to a safe home once we've
gone through the vetting process.
It is tough, it's challenging, and it's expensive, but
we're going to do it right.
Senator Blunt. Thank you, Mr. Secretary, thanks.
Senator Reed. Thank you very much, Senator Blunt. And now,
on behalf of Chairwoman Murray, let me recognize Senator
Schatz.
TELEHEALTH
Senator Schatz. Thank you Mr. Chairman, Ranking Member.
Thank you, Secretary. Last month, Mr. Secretary, you said that
telehealth can be a godsend. I agree. 55 senators on a
bipartisan basis who cosponsored my telehealth bill agree, but
we're facing a telehealth cliff, because your current authority
to expand Medicare's coverage of telehealth expires when the
public health emergency ends.
Unless Congress acts, we will go back to the Dark Ages,
with very limited access to telehealth. So, Secretary, do you
believe that Medicare beneficiaries should have access to
telehealth, no matter whether they live in rural or urban
areas?
Secretary Becerra. Absolutely. Telehealth is something that
we have to move towards. We learned lessons from COVID, and I
hope that you all are able to agree on legislation that gives
us more authority.
Senator Schatz. Do you think that it's important that
Medicare beneficiaries are able to use telehealth in their
homes?
Secretary Becerra. We want to make sure telehealth reaches
every part of the beneficiaries' surroundings. I want to be
careful here, because we want to make sure there's
accountability, and there are some proposals that would show
that accountability. But we want to make sure that, in fact, if
we're going to provide reimbursement for that service, that
those beneficiaries are receiving real service.
Senator Schatz. Are you satisfied that the current law that
we're utilizing under this public health emergency is working,
and that there's sufficient accountability?
Secretary Becerra. Thank you for asking it that way. I
think we need better authority.
Senator Schatz. Thank you. Do you believe that federally
qualified health centers and rural health clinics should be
able to provide telehealth services to their patients?
Secretary Becerra. Again, with accountability, yes.
Senator Schatz. Do I have your commitment to work with
Congress to provide the necessary data and technical assistance
that we need to enact these telehealth policies this year?
Secretary Becerra. You have me at hello on that one.
NATIVE HAWAIIAN HEALTH
Senator Schatz. All right. Great. Let me just talk to you a
little bit about issues of native Hawaiian health. The U.S.
shares a unique political relationship with the native Hawaiian
community. Different Federal agencies within HHS are
responsible for the administration of native healthcare
programs, but the same Federal trust responsibility requires
the provision of comprehensive, quality healthcare to native
Hawaiians, Alaska natives, and American Indians.
But native Hawaiians are often overlooked or left out of
HHS initiatives, and it does not always seem that HHS staff
understand the Federal trust responsibility to native
Hawaiians, and I don't think this is anybody's fault. We do
oftentimes fall under a different statutory architecture
because there's not a treaty relationship, there's a trust
relationship, and so, what I'm really asking is if you would
lay eyes on this particular relationship.
The way the statutory architecture works is sort of, in my
view, immaterial to whether or not we're going to recognize
this trust responsibility, and then in its implementation as we
do native Hawaiian health programs, and other dollars that flow
through HHS, we want to make sure that we are on equal footing
with all native people. Do I have your commitment for that?
Secretary Becerra. Absolutely.
PUBLIC HEALTH EMERGENCY FUND
Senator Schatz. Thank you very much. We have seen a--I want
to talk to you about one final thing, and this is the Public
Health Emergency Fund. We've seen a pattern where every few
years, when an infectious disease outbreak or public health
emergency occurs, we're taken by surprise, totally flat-footed.
The Federal Government cobbles together funding, and then
Congress appropriates.
But often, these are delayed, and they're delayed for
idiosyncratic reasons, whether the particular disease resonates
with the public, whether or not Congress is in session, and so,
you know, the idea here is to establish a reserve fund so that
you don't have to come back to Congress in order to respond to
a public health emergency.
Do you think it would be helpful for Federal response
agencies such as CDC, FDA (Food and Drug Administration), and
NIH to be able to respond proactively and get ahead of these
public health emergencies before they get out of control, and
then you have to come to Congress and ask for not a few
billion, but a few hundred billion?
Secretary Becerra. Senator, I think I have to hire you, but
yes, the answer is yes.
Senator Schatz. Well, I'm often told if this doesn't work
out, I'd be an okay staffer.
[Laughter.]
Senator Schatz. Thanks very much.
Secretary Becerra. Thank you.
Senator Murray [presiding]. Senator Manchin is next, I
believe. He is not down there? Okay, we'll turn to Senator
Baldwin.
SHORT TERM PLANS
Senator Baldwin. Thank you, Madam Chair. A record 31
million Americans have obtained coverage through the Affordable
Care Act, and that's in part thanks to this administration's
efforts to stand up a special enrollment period, and increase
funding for the Navigator Program, which assists people in
searching for a plan that's right for them. These are two of my
top priorities that I called for at the very beginning of the
pandemic, but obviously didn't occur until this year.
I know that these actions have made a huge difference in
people's lives. Unfortunately, under the previous
administration, there were rules changes that allowed the
proliferation of plans that I would refer to as junk insurance
plans, that don't have to provide the same protections based on
pre-existing conditions, et cetera.
Secretary Becerra, does the administration have any way of
knowing how many Americans have signed up for these junk
insurance plans?
Secretary Becerra. Senator, I don't know if we can give a
precise number, but we do know that the number of people who've
signed up for these plans has increased, and it is very
troublesome, because now we see the consequences when you think
you have insurance, and you go and use services, and lo and
behold, you're going to pay out-of-pocket a whole lot of money.
Senator Baldwin. Yes. We also know that many of these plans
engage in deceptive or misleading marketing practices kind of
aimed at confusing customers during both special enrollment
periods and open enrollment. At a time when comprehensive
coverage is more affordable than ever, and the administration
is working to get more Americans covered, why hasn't there been
any sort of action taken to combat these junk plans and their
practices?
Secretary Becerra. Probably the best answer there, Senator,
is stay tuned. We are looking to do some things. We want to
make sure whatever we do withstands any legal challenge, but we
are taking a close look at these plans that are really offering
no real benefit or service to the people who are paying money.
And so, I'd look forward to working with you on that, because
it is a development that is alarming, especially during this
time of pandemic when everyone needs to know what they actually
have access to.
MEDICAID REENTRY ACT
Senator Baldwin. Exactly. I look forward to working with
you on that. Incarcerated and newly released individuals who
have substance use disorder are at significant risk of overdose
and death, as well as recidivism. And during the pandemic,
these individuals have been at a substantially higher risk of
contracting and dying from COVID-19. I was proud to introduce a
bipartisan measure called the Medicaid Reentry Act, which would
allow States to restart Medicaid coverage for eligible
individuals 30 days prior to their release from a jail or
prison. This coverage is really vital to facilitating what we
might call a warm hand-off to addiction treatment and other
healthcare services. Mr. Secretary, can you speak to the
importance of providing comprehensive care for reentering
individuals, and will you commit to working with me to pass and
implement the Medicaid Reentry Act?
Secretary Becerra. Senator, not only do I want to be
supportive, we want to help get this through quicker than you
think, because so many people are falling through the cracks,
and we know that there is a way to help many of these folks.
We just put out, about 2 or 3 weeks ago, we announced $3
billion that we were putting out as a result of your good work
on the American Rescue Plan. $3 billion, half of which is going
to go towards substance use disorder services, and the other
half for mental health issues, and so, we want to get out there
quickly, and so, we look forward to working with you on this,
because this is a major endeavor.
We have money in the budget to help us deal with folks who
are reintegrating back into the community, and so, very much
prepared to do that work with you.
STRATEGIC NATIONAL STOCKPILE
Senator Baldwin. Yes. I believe you've been asked some
questions, significant questions, on the Strategic National
Stockpile already in this hearing. I just wanted to note that I
spent much of last year writing letters to the previous
administration to ensure that my State, the State of Wisconsin,
received the supplies that it needed from the Strategic
National Stockpile to combat COVID-19. And unfortunately, it
often took you know, public pleas from governors and Senators,
and letters from congressional delegations as a whole for
States to obtain the supplies that they needed during this
crisis in its early days.
And that's unacceptable. The President's fiscal year 2022
budget calls for an increase of $200 million for the Strategic
National Stockpile, including for modernizing the Stockpile's
distribution model, and increasing visibility of the domestic
supply chain to improve our response capabilities.
So, can you describe how HHS has worked to increase the
supplies available in the Stockpile? And why it's important for
us to prioritize this funding for distribution and oversight
improvements.
Secretary Becerra. Senator, first I want to thank you for
the good work that you've done here. This probably looks very
familiar, what you see in the budget, because it really follows
much of what you were proposing and calling for. And so, we do
want to increase the transport of supplies, the capabilities.
We want to refine and modernize our inventory. We want to be
able to track our supplies better. We want to be able to expand
domestic manufacturing. The $10 billion that was made available
for us to really focus on domestic manufacturing will be
critical.
All that's going to get underway. More will be done if we
get a budget that reflects those priorities. If we can move the
budget from $900 million to $1.1 billion, that's significant.
And if that is included, then we can really launch in ways that
really let us make sure that we tell the American people we're
stockpiling for what you need to get ready for in the future,
and not say, ``Oops, we didn't realize we'd need that,'' when
it finally hits us.
Senator Baldwin. Thank you.
Senator Murray. Thank you. Senator Shaheen.
Senator Shaheen. Thank you, Madam Chairman. Mr. Secretary,
we're delighted to have you in front of us this morning, and
congratulations on your new role. You are in a position that
touches the lives of the majority of Americans, and so, we
appreciate your good work.
EXCESS VACCINES
I wanted to first ask you about a news report I heard this
morning on the number of States that have excess vaccines,
coronavirus vaccines that are going to expire if we don't
figure out some way to use them. Estimates I've seen say that
as many as 500 million excess vaccines could be available by
fall.
I just came back from a trip to Eastern Europe, where they
are desperate for vaccines. While I was there, we were able to
announce the decision to provide vaccines to the country of
Georgia, and they were very pleased to hear that.
Are we considering doing more to make those excess vaccines
available to countries that are really in need?
Secretary Becerra. Senator, thank you for the question.
Obviously troubling if we do see vaccines expire, but we are
working with our state partners. The difficulty is we have to
make sure there's a process that's orderly, that we could
ensure the utility of the vaccine, and that people can have
confidence that it is still a viable vaccine.
And so, there are a number of things that we have to do if
we're going to move that vaccine, because you need to have that
chain of custody in place. And so, we're absolutely working
with our state partners on this.
We want to make sure our state partners understand that, as
much as they may want to just get out there and help somebody,
we have to do it the right way, because we have to have the
confidence that the vaccines still work.
Senator Shaheen. Well, I appreciate that. I agree that's
very important, but we know that China is doing this very well.
In fact, when I was at a dinner in Georgia, I sat next to a
woman who had just had her second vaccine from China. And so,
if they can do it, we ought to be able to do it, and we should
make this a priority. So, I hope you will agree to do your part
to help make that happen.
Secretary Becerra. We'll make it a priority, but we'll do
it our way, not China's way.
STATE OPIOID RESPONSE GRANTS
Senator Shaheen. That's appropriate. New Hampshire's one of
those States that's been very hard hit by the substance misuse,
and the opioid epidemic has hit us very hard. The decision by
the previous administration to provide set-aside funding to
help the hardest hit States was very helpful to us, those State
opioid response grants that came to us, and the support in so
many other ways.
We have gotten much better at saving people's lives through
Narcan and other means, but we're seeing people migrate to
other substances, methamphetamines, cocaine, heroin, and I hope
that you will commit to work with our office and some of those
other States that have been so hard hit so that even though our
overdose death rate may be flat, we don't see a dramatic drop
in funding because of that.
Secretary Becerra. Senator, as you probably saw in our
budget, we actually try to increase the amount of money there
is----
Senator Shaheen. Which I appreciate.
Secretary Becerra. Yes, the State opioid response grants
that are out there. And so, we hope to work with New Hampshire
and all the States. Quite honestly, there's not a State in the
country that isn't being impacted by opioids. Some, however,
like your State, more impacted than others.
And so, definitely looking forward to working with you.
This is one issue where I did a lot of work as State AG
(Attorney General). I would have thought by now we might have
heard, but I know there is a settlement in the making that will
help supplement what the Federal Government is doing, and I
hope together, with what the States acquire through a
settlement, and what we're able to do working with you, we can
actually tackle this in a meaningful way.
Senator Shaheen. Well, now that we are seeing COVID in our
rear-view mirror, it will really be important to get back to
some of those programs so that we can reach people, so that we
can make progress, and I appreciate the commitment that you
have.
CHILDCARE PROVIDERS
One of the other areas that has been heavily impacted
because of the coronavirus has been childcare. We've seen the
reports of what's happened to women because they can't get
childcare anymore. In meeting with childcare providers in New
Hampshire, they have had a very difficult time, and continue to
have, as people try and come back, and they try and provide
coverage for families. But one challenge has been expediting
the funds that are going out to States, and it's an issue for
us at the State level, as well, because of the challenge of
making sure people understand the guidance and are very clear.
What I heard from childcare providers is that they don't
want to spend money and then find out later that they haven't
complied with the rules and have to give it back. So, will you
work with New Hampshire and other States to make sure that that
guidance and assistance is there for our childcare providers,
who are really struggling at this time?
Secretary Becerra. Absolutely. Absolutely, and I look for
your guidance, and any member who wishes to make sure that we
are working closely with your state partners.
HEALTH INSURANCE SUBSIDIES
Senator Shaheen. Thank you. Finally, I've only got a few
seconds left, but if I could, Madam Chair, just ask a final
question about health insurance, because we have a chart here
that shows what would happen if we are able to address
deductibles in a way that does what the American Rescue Plan
did to help expand coverage. And what this shows is--I have
legislation that would tie the plans and deductibles to the
Gold plan rather than the Silver plan. And so, this shows what
happens for a family making $25,000 or less, in terms of the
impact of expanding the help so that they could get additional
assistance with their deductibles if we peg it to the Gold plan
rather than the Silver plan.
And you can see the numbers behind me for medium cost-
sharing assistance is $800. For the highest cost-sharing
assistance right now, it's $177. So, it would be really helpful
to families to be able to expand, thus, to help with those
deductible costs, and I hope we can work with you to do that.
Secretary Becerra. Senator, I'd only add--I know time has
expired--I'd only add that President Biden made a very strong
commitment here, and the fact that we are trying to extend
permanently the increase in subsidies that families get would
be tremendously important, because all those families who
you're pointing to who fall off that cliff, that fiscal cliff,
when they hit that point in their income, where they no longer
get the subsidies.
Senator Shaheen. Right.
Secretary Becerra. Wow. All of a sudden, they can't afford
the care, and President Biden wants to extend the good work
that you all did to provide additional subsidies for those
middle-class families. So, we want to work with you.
Senator Shaheen. Thank you, I appreciate it. Thank you,
Madam Chair.
Senator Murray. Thank you. Thank you. We have been honored
to be joined by the Chair of the full committee, Senator Leahy.
Thank you for being here. Turn to you.
Senator Leahy. Thank you very, very much. Thank you and
Senator Blunt for having this hearing. I appreciate having the
Secretary here. I should note for the record, the Secretary and
I have known each other for years. We've worked together at the
Smithsonian as regents, and he knows that I'm a huge fan of
his, and I look forward to working with him on this.
I was glad to see a large increase in funding to support
research and prevention treatment. Recovery support services,
as you can tell from Senator Shaheen's question and others, and
your own experience, really concerns all of us. We see the
fatalities in opioid overdoses going up. We tried a lot of
innovative, community-based approaches in my State of Vermont,
and with your own experience in the Congress, you know that
it's not unusual for local issues to come up among the members
of the Appropriations Committee.
ALTERNATIVES TO OPIOIDS FOR TREATMENT OF CHRONIC PAIN
But I think that research to addiction alternatives has
lagged at the Federal level. I think we have to have more
research on chronic pain management and treatment, other than
through the use of opioid painkillers, and I think that is
extremely important, because we're going to need to help people
with the chronic pains. Will your budget support funding for
alternatives to opioids for treatment of chronic pain?
Secretary Becerra. Mr. Chairman, first, great to see you,
and thank you for your concern and the work that you've done.
We're going to try to be as flexible as we can, because the
solutions to opioids will not come from Washington, D.C., the
support will, and we can provide some resources, so there are
any number of ways to tackle substance abuse disorders, and,
quite honestly, and one of the things I found when I was the
attorney general of California is that even the medications
differ in their utility State by State.
And so, we have to be able to provide our state partners,
local partners the flexibility. They're the ones that are going
to do the work. They're the ones who have the know-how. We want
to provide the support and be a partner.
Senator Leahy. I know that the University of Vermont, their
Center of Rural Addiction helps rural counties, and the budget
includes a request increase of $55 million for rural
communities' opioid response programs. And I hope we can use
that to train, recruit, retain addiction specialists to serve
in rural areas, because obviously, a State like mine, and
actually every State here, has rural areas, and I would hope
that you could look at what they're doing in the Center of
Rural Addiction that we have. There could be similar ones in
other States, and I just want you to think about how we can
most effectively use that funding.
Secretary Becerra. And Senator, again, having come from a
position as a leader in my State of California, I want to now,
as Secretary at the Federal level, make sure that I'm listening
as closely as I can to the local leaders. And so, what we try
to do should be to try to support the innovation, the best
practices locally.
Opioids is going to be very difficult, and even with all
the resources that we're providing, and that this future
settlement may provide with the attorneys general, it's still a
bear. And we've learned many things about how to deal with
opioids, but it's still going to be a bear, and so, whether
it's rural or inner city urban, there are people doing this on
the ground, and we should go with the most effective best
practices that are out there.
TELEHEALTH
Senator Leahy. Well, and I will make sure I get to you some
of the things that we're doing, because the rural health
programs are much needed. Telehealth is very needed, but then
you have the problem that many of us find in rural areas,
broadband connectivity and all these others, it's not the
medication, it's getting the telehealth there in the first
place. So, I hope your budget will address some of these
issues.
Secretary Becerra. Yes. And Senator, we spoke a little
earlier about telehealth, and one of the things you want to do
with telehealth as you learn from what COVID has taught us is
to make sure that we expand access to that Internet service, to
that technology. And it would be a shame, especially in rural
communities that you just mentioned, and its poor rural and
urban communities, if we expand telehealth but forget them
because they can't get it because they lack good broadband.
Senator Leahy. Thank you. Thank you, Madam Chairman.
Senator Murray. Thank you, Mr. Chairman. Senator Capito.
Senator Capito. Thank you, Chair Murray. I appreciate the
hearing, and thank you, Secretary Becerra, who we served
together, and congratulations on your new position. Before I
begin to ask questions, I just wanted to echo the theme that I
know Ranking Member Blunt had conveyed, and I share.
I am the ranking member on Homeland Security, and so I have
a particular interest in this, and I am, Mr. Secretary, I can't
decide if I'm frustrated or grateful, but you have overseen the
transfer and reprogramming of almost $3 billion within your
department from COVID-related purposes. I believe testing and
strategic reserve is where those dollars came from, to address
the migrant crisis at the border.
So, I'm frustrated you ignored the intent of the funds, but
I appreciate that your action signals to your own
administration something that we have been calling for months,
and that is that billions of unspent COVID funds can and should
be used for a more pressing need.
My question is--I'm very interested, obviously, as a
citizen and a representative from West Virginia, on the opioid
and overdose issue, but I think you've answered that, and we
certainly want to be a partner. When you mentioned that the
answers are local, can be found locally, I think our State in
many sections of our State, and Senator Manchin I think would
agree here, have come forth with some tremendous ideas to be
solutions to the problem that are community based, that are
widespread within the community, and that lift those
communities.
Unfortunately, the pandemic--there's a lot of backsliding,
as you know, so we've got to get this right back on the screen.
And we also have along with that an increase in my own home
county of HIV, which is very concerning to me, and I'm hoping
that the CDC, while they're in our State right now on this
issue, can be a bit more aggressive there.
ALZHEIMER'S DISEASE
What I wanted to ask, then, I'll move to another area of
passion for me, and that's the Alzheimer's disease. We saw most
recently that a new treatment that emerged and was approved,
tentatively, I think, is targeted for people at early stages of
Alzheimer's disease. And it is the only drug on the market that
aims to slow the brain's deterioration instead of just treating
the symptoms.
But along with this comes an effort that we've had,
bipartisan here in the Senate, which is this new--not new, but
the existing welcome to Medicare initial exam, where we are
empowering and trying to empower our medical professionals to
begin asking questions early to try to meet the challenges that
not just that particular Medicare patient could have, but also
the family. As you know, caring for the folks afflicted with
Alzheimer's is very intense, and very, very difficult for
families. And expensive.
But in those visits, we encourage screen detection,
diagnosis, and other things of related dementia. I think what
we have here is, if we have this progression of a possibility
of a drug that can help, we need to merge this with the welcome
to Medicare exam so that we are expanding the possibilities
that a welcome to Medicare exam could do, and sort of heading
off what could be the later ravages of Alzheimer's.
I don't know if you all have thought about that, in terms
of Medicare, what your perspectives might be there.
Secretary Becerra. Senator, you've hit on something that's
crucial as we continue to see innovation in new medicines, and
that is how do we incorporate them, because these are not
inexpensive medicines.
Senator Capito. Right.
Secretary Becerra. And so, to your point, the earlier we
start in the process of trying to detect conditions that a
person might present with, the sooner we'll know if we have to
provide these types of medicines. And it's going to save us a
lot of money if we get them upfront versus later stages when
it's extremely expensive to treat some of these very difficult,
devastating diseases.
So, I think you're absolutely right. It's the preventative
model. It's approaching folks early. It's trying to do the
intervention while you can, and maybe have a chance to either
slow, or maybe in some cases cure the condition. But certainly,
we should not be waiting until it's at its worst point.
Senator Capito. Right. I agree with that. This one is a
particular challenge, as you know, because it's not something
that maybe is apparent in your blood count, or you know, you
can physically see it. It's something that those of us who have
experienced, and comes on very gradually in some cases, and
before you know it, you can't ask that last question. So, I
thank you for your dedication here. I want to work with your
department to see if we can enhance that welcome to Medicare
wellness check so we can prevent on the front end. Thank you.
Secretary Becerra. Thank you.
Senator Murray. Senator Manchin.
DOMESTIC MANUFACTURING
Senator Manchin. Thank you, Madam Chairman. Secretary, the
Food and Drug Administration reports that nearly 40 percent of
finished drugs, and roughly 80 percent of active pharmaceutical
ingredients are manufactured abroad. Widespread shortages of
personal protective equipment, the PPEs as we know, and other
medical equipment at the beginning of the COVID-19 had a
disastrous impact on all of us, in hospitals and consumers
especially.
While global shortages of semiconductors in recent months
forced U.S. manufacturers to slow or halt production lines.
Just yesterday, President Biden directed Federal agencies to
institute whole of government efforts to strengthen domestic
competitiveness, and supply chain resilience, important to
supporting domestic manufacturing of generic essential
medicines.
So, how is HHS responding to this directive to strengthen
our domestic supply chain?
Secretary Becerra. Senator, we've had conversations on
this. And thank you, first, for providing us with some
resources. The American Rescue Plan does provide us several
billion dollars to try to move towards more domestic
manufacturing. We've also seen as a result of COVID and the
Strategic Stockpile how we lack the kinds of product and
medicines that we needed.
And so, what we're trying to do is, working within ASPR,
(Assistant Secretary for Preparedness and Response) the agency
within HHS that would deal with this, we're trying to move as
quickly as we can to start having a stockpile that really will
have us ready for the 21st century. We know COVID's not the
last pandemic, and so we want to be ready. This report that was
just issued yesterday that speaks to these issues on domestic
manufacturing will go a long way in directing all of us in how
we do this. But, no doubt, when it comes to anything related to
health, HHS has to be on top of it.
Senator Manchin. Has HHS done any type of an inventory,
looking at what manufacturing facilities might be able to be
restarted if or if not, or basically put into production for
the needs of our country?
Secretary Becerra. I'd say that's underway----
Senator Manchin. Okay.
Secretary Becerra [continuing]. Nowhere near completion.
Senator Manchin. If you can, whenever you can have your
people working on that, or we can work with them or something--
--
Secretary Becerra. Yes.
Senator Manchin [continuing]. Identifying those facilities.
Secretary Becerra. Absolutely.
OPIOIDS
Senator Manchin. Sir, also, we had 90,000 Americans die
from overdose last year. My State's been hit the hardest. We
have an average of about 70 to 75 thousand every year. We had a
spike because of the COVID. The problem that I have seen is
that basically they're putting more and more products on the
market. Manufacturers are producing larger and larger volumes.
It just doesn't stop, and I've never seen any of us being able
to stop that or thwart that, so, if we know that these opioids
are causing the problem, we need treatment centers, and we have
not enough.
I look at domestic shelters we have. When we identified
domestic violence as really an epidemic in our country, we put
domestic shelters in about every neighborhood. This is an
epidemic. Overdose. So, I've had a piece of legislation called
Lifeboat, and all we're doing is saying you will pay one penny
per milligram production fee if you're going to make opioids.
We never had opioids when you and I were growing up in it,
okay? So, if this is what they think that they need, and that's
their model business model, then you're going to pay for one
penny per milligram, and every penny of that goes into
treatment centers. So, every part of our Nation, any part of
our Nation will have treatment centers to help people. Is it
something you all think you could support, or have you heard
much about it, or can we set with yours?
Secretary Becerra. We look forward to working with you on
that because we agree. In fact, just two or three weeks ago--I
already mentioned this earlier--we put out grant funding of $3
billion, half of which----
Senator Manchin. You went $3.7. I applaud you all on the
three and a half billion.
Secretary Becerra. Yes. We're still----
Senator Manchin. But still yet, it kind of goes you know,
we hit these ebbs. This would be consistent. $2 billion a year.
One penny is $2 billion a year.
Secretary Becerra. Yes.
Senator Manchin. Unbelievable. It doesn't hurt anybody.
Secretary Becerra. Go to it. We'll offer you whatever
technical assistance and whatever else we can, because what
we're putting in our budget and we've already done through the
American Rescue Plan, what you all have been working on, we're
still not keeping pace with this epidemic.
340B
Senator Manchin. With the need. I agree with you. Thank
you. And then also, my final question. The 340B program is
essential for providing access to safe and affordable
medications for low-income West Virginians, and low-income all
over our country. Recently, HHS determined that six
pharmaceutical companies have violated the program by
restricting access to contract pharmacies.
The undermining of the 340B program by pharmaceutical
companies and pharmacies' benefit managers has taken its toll
on my West Virginia hospitals, community health centers, and
their contract pharmacy partners, and I'm sure in every State
every one of us have been hit with this. What are the next
steps that you will take as the head of HHS to ensure the
integrity of the 340B program?
Secretary Becerra. Well, Senator, as you just said, we just
put out, in writing, we didn't just say it verbally, we put
out, in writing, a clear message to these six manufacturers
that we believe that they're violating the law. You violate the
law, you pay the consequences, and so----
Senator Manchin. Has it been turned over to DOJ (Department
of Justice)?
Secretary Becerra. We're waiting for responses.
Senator Manchin. Okay.
Secretary Becerra. Some have responded, but we're waiting
for full responses. By the way, our budget also does increase
funding in this area. I think we provide almost a doubling, not
quite a doubling of the money that is available to make sure
that we can do the grant rule-making that we need. I hope what
you'll do is you'll give us more authority to actually give
clear guidance on what can be done and can't be done on 340B
because----
Senator Manchin. And I really think we could do that in a
bipartisan way, because I tell you, we're all being affected.
Every one of us.
Secretary Becerra. That would be helpful, because this way
the manufacturers can't sort of play this shell game with us.
Senator Manchin. Okay.
Secretary Becerra. They'd know what their responsibility
is.
Senator Manchin. Well, I look forward to working with you,
and thank you for your service, Secretary.
Secretary Becerra. Thank you.
Senator Manchin. Thank you, Madam Chairman.
Senator Murray. Thank you. Senator Hyde-Smith.
Senator Hyde-Smith. Thank you, Madam Chairman. Mr.
Secretary, I recently visited the border with several of my
colleagues a few months ago, and we just saw how many children
were down there. The issue that's going on. The possibility of
thousands of illegal immigrants crossing the Southern border
and being transported to our State and housed in facilities in
Mississippi is what the concern is.
UNACCOMPANIED CHILDREN
But I understand that your department reached out to many
States, including Mississippi, to identify potential housing
locations for these unaccompanied migrant children, and when
Mississippi declined to participate, your office sidestepped
State and local governments by asking private organizations and
nonprofits to house the immigrant children.
And I've been getting several calls on this. I mean, from a
friend who said the local caterer just had a called asking,
``can you put in a bid of feeding 200 seven days a week, three
times a day?'' Where is this coming from, Mr. Secretary? What
do you know about this? Do we need to get our local resources
ramped up for these children coming in? And I said, I know
nothing about this.
But this action, you know, just ignored the elected
officials, who said that they were not going to participate,
and they're not being notified or given up-to-date information.
We just have to rely on these calls that we get. But you know,
there's just no transparency whatsoever in the last few weeks,
other than calls from my local sheriff saying, ``I heard this
is happening,'' because of the inquiries being made in the
community.
It is of great concern to me and my constituents that HHS
would send distressed children to States without the
involvement or approval of those States and communities and
without the resources and security that we would need to care
for such a large influx of migrants.
But I firmly believe this administration's misguided
actions have created a humanitarian crisis on the Southern
border, and you know, they're looking for the States to pick up
the pieces, to make this happen if those children get
transported without our knowledge into our State.
Does your department plan to continue on this path and to
circumvent the will of the State governments? Do they plan to
continue that if we know best what the capabilities of us
serving those children are, and how do you plan to improve
communications with the States and provide up-to-date
transparent information on the UC (unaccompanied children)
program?
Secretary Becerra. Senator, thank you for the question.
Very important. And by the way, I hope in the future you feel
comfortable reaching out to me. I'd like to develop that
relationship with you so that your team and my team can work
together on some of these issues. On this particular matter, my
sense is that some of the information that you've been given is
not only incorrect, but it's disturbing.
We never make any approach into a State without talking to
the State's leadership, and local leadership. As you just
mentioned yourself that some of the State officials said that
they were approached and they rejected the opportunity to have
some of these migrant kids go into their State.
We have an obligation to provide a safe place for these
children. We typically look for licensed care facilities,
people who are licensed and trained to do this. They're
children. And so, we go wherever we can. We do reach out to the
State leadership to see if they will help us, but if the State
leadership doesn't want to help us with children who are in
distress, we still have an obligation to find a place for these
kids.
We do nothing behind anyone's back, because all these
facilities are licensed by the very State. And so, whoever is
telling you that they don't know anything about this is either
being disingenuous or they're not interested in helping us make
sure we take care of children. We don't offer them luxury, we
try to provide them with the basics. And we look for licensed
care facilities. We're not going to put them in a facility
where we don't have people who are trained to care for kids,
and we have to search far and wide throughout the United
States, because we don't just use facilities that are near the
borders where these kids cross.
And so, I would hope to be able to work with you and your
team to show you how we do this, because we're not hiding
anything. What I can guarantee you is that we're going to
provide a safe place for these kids while they're in our care.
However temporary it is, while they're in our care, we're going
to do this the right way. I suspect you have kids or grandkids.
I have children. No grandkids yet. I would expect whoever has
my child to take the best care they can with what they've got.
Senator Hyde-Smith. But you do understand the concerns of
the local medical facilities and law enforcement if we were to
overnight get 200 children in a small area.
Secretary Becerra. Certainly, if that were the case. But
that never happens, because we don't do something overnight.
You can't, not with 200 kids. There's nothing you can do with
200 kids that is just done overnight. We have to go through the
process of establishing the relationship. Remember, most of
these licensed facilities can't accommodate more than just a
handful of kids.
The emergency intake sites that we have stood up,
principally in places like Texas and in California, those are
large. But those take months. In some cases, maybe weeks, but
months to stand up. And there's no way to hide when you have a
facility that's holding maybe three or 400 kids, or more from
the sight of any official.
But the licensed care facilities are typically 10, 12, 20
kids, and the State knows about it because these folks, these
facilities have to seek a license from the State in order to
operate. These are facilities that operate for these migrant
children, unaccompanied migrant children. We don't take money
from the foster care program to do this. It is a separate
stand-alone program, because there are special circumstances.
These kids are here under temporary--not even status--they
are requesting asylum, and so we have to process them. That's
done by DOJ and DHS (Department of Homeland Security), but we
have the responsibility, HHS, to provide them with the care,
either under our custody, or if we're able to find a
responsible custodian, temporarily in that custodian's care.
And the only activity that might occur in your State is
only the result of having worked with that licensed care
facility to reach an arrangement to have some of these kids
housed temporarily there.
Senator Hyde-Smith. Well, we may be contacting you, because
it was a large number of calls. It was a couple hundred all in
one, and the locals--and, of course we called everybody we knew
in Mississippi, and no one knew anything about it. So, we may
be contacting you on that, because----
Secretary Becerra. Please do so.
Senator Hyde-Smith [continuing]. You know, we just
definitely want to be prepared and know those things.
Secretary Becerra. Please, I invite you to.
FETAL TISSUE RESEARCH
Senator Hyde-Smith. Another concern I have is funding
research that uses fetal tissue from unborn children who have
been aborted, I believe that science is best when it's ethical
and respects the dignity of life. I also believe that the
Americans who object to abortion should not have their taxpayer
dollars going toward purchasing fetal tissue from abortionists
like Planned Parenthood.
Furthermore, even the American Medical Association has
raised concerns regarding the serious ethical problems created
by the financial benefits to those involved in the sale of
fetal tissue. And I'm over my time, but I just want to make a
couple of points here. Is----
Senator Murray. If the Senator could be concise, we've got
another Senator waiting quite a bit of time, and you are way
over time.
Senator Hyde-Smith [continuing]. We are concerned about
that, and that the justification rule from 1995 is still being
used, and we know that science has changed a lot since 1995,
and so we may want to have another discussion about that. Thank
you, Madam Chairman.
Secretary Becerra. Look forward to it.
Senator Murray. Thank you. Senator Murphy.
Senator Murphy. Thank you very much, Madam Chair. Let me
just underscore the Secretary's remarks about these kids and
the facilities they're in. These are State-licensed facilities,
as the Secretary said repeatedly. These are not federally
licensed facilities. And so every State knows where these kids
are, and they all have the opportunity, if they want to, to
pull the license, modify the license, do whatever they need to
do.
But, let's be honest, these kids are not security concerns.
I mean, I understand there's a logistical effort necessary to
care for these kids, and I would hope that notwithstanding
folks' political opposition to the President, we would all
agree that if these kids are here applying for asylum, we
should you know, all be in the business of trying to you know,
make sure that they have a roof over their head. But they're
not a security concern. These are you know, 13-, 14-, 15-year-
old kids who you know, fled destitute poverty and violence to
come to a better life, and are temporarily in our care until
they get connected with a relative. So, I just don't want to
overstate the danger or the impact that these young people
have.
Let me just, Mr. Secretary, associate myself with the
remarks of Senator Baldwin on the short-term, limited duration
plans. I wasn't here for your answer, but I heard that you said
we should wait and stay put for additional announcements. I
hope that that is coming shortly. These plans you know, they're
just frauds. They're sold a bill of goods, these folks who pick
them up, and then find out that they actually have no
insurance, and I hope that we can get those out of the
marketplace as quickly as possible.
My question to you is around the proposal for additional
ACA (Affordable Care Act) premium subsidies, about $60 billion
in the President's budget over the next 4 years to continue the
increased subsidies, and I thank Senator Shaheen for her
advocacy and her leadership on this. I'm very supportive of
that proposal, but I just want to point out that that is $60
billion not necessarily going to consumers. That's $60 billion
that's going to the for-profit healthcare industry. That's $60
billion that's going to end up in the pockets of insurance
companies, and drug companies, medical device companies, for-
profit hospitals. You know, all sorts of entities that are just
making a king's ransom off of our healthcare system today.
I'm very glad that Senator Murray and Chairman Pallone have
kicked off a process by which we're going to, I gather, start
to come up with a path forward on a public option. The ability
to put a Medicare, Medicare-like plan on these exchanges that
does not have the kind of profit motive that private insurance
plans do, and, if done right, will provide some real price
pressure on the private sector.
PUBLIC OPTION
For instance, Senator Merkley and I have introduced what we
believe to be the sort of most aggressive public option, and in
it would be included bulk purchasing authority for you or for
CMS (Centers for Medicare and Medicaid Services) that would
result in a lower price for the Medicare-like plan. But it
would also create pressure that would have benefits to private
sector plans, as well.
What do you think of the process that has been announced in
the Senate and the House to begin conversations about public
option legislation? Do you see this as part of the answer on
price moving forward? Because my only worry about a strategy on
affordability that is predicated mostly on subsidy for the
exchanges is that that ends up just feeding the for-profit
health insurance and medical industry machine, which you know,
ends up doing very well for them, ends up in increased coverage
for Americans, but doesn't get at the price question.
Secretary Becerra. So, Senator, having served with you as
we were going through the process of passing the Affordable
Care Act, and having pushed for many of the things that you're
discussing, what I can tell is now, in this position, I just
want you all to get something done, because, give me some
authority to do something to lower costs, give me the ability
to try to drive down the cost of those services, and to expand
coverage.
Any number of good ideas, but I know that you all have to
go through this process and figure out how to get to the right
number to get something passed. The President has publicly
stated he is supportive of the public option, we have dollars
in this budget to try to support movement towards getting more
Americans onto coverage, and I would simply tell you, we're
ripe to get something done. The American public wants to see us
do something, and so, it's almost--yes to all of the above.
Just let's see something cross over the finish line.
Senator Murphy. I appreciate that the administration and
you have a lot on your plate right now, but at some point, some
leadership to point us and others in the right direction on
this question on how we construct a public option would
probably be helpful, but I thank the Chair for her leadership
on this. Thank you.
Senator Murray. Thank you. Senator Braun.
Senator Braun. Thank you, Madam Chair. Good to be talking
to you again----
Secretary Becerra. Thank you.
PARTIAL-BIRTH ABORTIONS
Senator Braun. February 23, in your nomination hearing, I
asked will you follow the law, and it was in reference to the
Hyde Amendment back then and some other things. Recently, you
were testifying in a House committee, and the subject of
partial-birth abortions came up, and I think there was some
confusion as to whether there was a law on the books or not,
and I assume that you of course now know there is.
I think what I'm interested in is not so much what you're
going to do to enforce existing law, what you might be
proposing or pushing when it comes to, you know, the issue of
abortion, sanctity of life. So, is there any interest in your
office pushing or trying to get legislation out there that
would overturn the ban on partial-birth abortions?
Secretary Becerra. Senator, thanks for the question, and
thanks for following up from our previous discussion on this. I
think the President has been fairly clear, and maybe if I
wasn't so clear in my previous testimony, I could try to
elaborate a bit. We're going to do what the law permits us to
do. We're going to follow the law. This is a subject that,
obviously, people differ on. These issues usually are premised
on very deeply held beliefs. But what I can tell you is that if
I'm doing my job, I'm following the law, and right now, Roe v.
Wade is the law of the land.
We're going to do everything we can to protect a woman's
reproductive rights, to have healthcare. We want everyone to
have access equitably to healthcare, and so, we're going to do
everything we can to make sure that whether you're rich, poor,
young, old, tall, short, you're going to have access to the
care you need.
HYDE AMENDMENT
Senator Braun. So, the current law incorporates the Hyde
Amendment, and in the President's budget, that is a clear
omission. So, does that mean that, and were you part of the
formulation of the budget you know, that would have that not as
part of it? And that's been around since 1977. So, when you
hear statements that would be unclear about an existing law of
partial-birth abortions, which you actually voted against that
law, the one banning it, it would give many of us pause in
terms of what might be done.
You're clear that you're going to respect the law, but I
think I'm more interested in what you might be interested in
doing to change the law. And the fact that the Hyde Amendment
is not part of the budget, is that something more ominous on
the horizon that it would be incorporated into law, at least
it's reflected in the proposed budget, and were you part of
crafting that omission?
Secretary Becerra. Remember, Senator that President Biden,
before he became president, said that he would be against
maintaining the Hyde Amendment, and so, the budget is a
reflection of what the President has said in the past. I have
thousands of votes in my 24 years in the House of
Representatives. I think my record's pretty clear where I stand
on this issue, as well.
But, as you just said, my obligation is to respect the law,
and the law is not established by the executive, it is
established by Congress. And so, we will respect and follow
whatever the law is that you all pass.
Senator Braun. Well, I'm glad to hear you're going to
respect the law. I think that would be the minimum that we'd
require out of anyone here in any capacity, and I think that
what you're saying is that you may be trying to change the law,
and President Biden has been clear, according to you, that he
does not want the Hyde Amendment to be part of what ideally
would be part of law in that area.
And then, what would worry some of us is that then the next
step might be taken to where partial-birth abortions come into
play, and I think it just good to be honest about what one's
intentions are, and we're in a climate right now when it looks
like there's a lot out there legislatively, and for any of us
that are passionate about the sanctity of life, it is
something--obviously, we would love to know clearly you know,
what the intentions of the administration would be. Your
intentions and lawmakers, as well. So, I think that we're not
going to get any further on that topic here today, but I
thought it was definitely worth mentioning.
Secretary Becerra. Senator, I look forward to working with
you. The art of compromise and the ability to come together is
what makes this democracy work, and so, we don't have to have
the exact same views to be able to get things done for the
country.
Senator Braun. Thank you.
Secretary Becerra. Thank you.
MATERNAL MORTALITY
Senator Murray. Thank you. Mr. Secretary, the U.S. is the
only industrialized nation where the maternal death rate is
rising. Each year, 700 women die due to pregnancy, childbirth,
or subsequent complications, according to the CDC, and the vast
majority of those deaths are preventable. Black, Tribal, and
women who live in rural areas are at much greater risk, so we
need to address the gaps in care for pregnant and postpartum
women and root out bias and discrimination in maternity care
settings.
So, I was really pleased to see your budget build on some
of our bipartisan investments that we've been making in recent
years to combat this crisis with $220 million across several
agencies within HHS. I want you to talk to us about how this
new funding will address the problems driving these disparities
for women of color and women who live in rural areas, and maybe
what lessons you've learned from the committee's initial
investments.
Secretary Becerra. Senator, thank you. This one is
important, not only because it's the right thing to do, but, as
you said, we as a country, as a Nation, a leading Nation are
doing something totally wrong when it comes to protecting
women, women who are going to help us move the next generation
of leaders. And so, it's time, and I'm thrilled that the
President saw the need to make a substantial investment here.
Not only is it the $3 billion to improve the maternal
health programs that we have under the American Families Plan
that he has proposed, but it's the $223 million that I hope we
get in funding, that's in this budget for a program that he
wants to start to help improve maternal health programs around
the country.
It is the challenge to States to say, under Medicaid, we
right now provide a woman 60 days of postpartum care after
she's delivered. We're saying, guess what? You join in, and
we'll give you--we'll help you pay for a full year's, 12
months' worth of care for that woman. Because it's not just the
delivery and the recuperation from the delivery, it's making
sure the woman is ready to move forward in that first year of
life of that child.
And so, this one's critical, and, as I've always mentioned,
this is something my wife, as an OBGYN has always talked so
much about. How we don't really care too much except for making
sure that we see the delivery go well. There's so much that
goes on before the delivery, and so much that has to go on
after. And to have in our own country, pockets of America where
women are still dying, or their children are dying at birth,
it's just incredible.
So, these are the investments that we need to make, and
it's unacceptable to not do otherwise.
Senator Murray. Well, thank you. I look forward to working
with you on that. Mr. Secretary, the number of migrant children
referred to HHS's care began steadily increasing last year,
including after courts enjoined the prior administration's
policy of applying Title 42 restrictions to unaccompanied
children. And at the same time, as you well know, COVID-related
limitations significantly reduced HHS's capacity in its entire
network of State licensed shelters.
UNACCOMPANIED CHILDREN EMERGENCY INTAKE SITES
And as a result of that, this administration inherited a
system already approaching a breaking point, and the use of
emergency intake sites has, thankfully, gotten a lot of our
kids out of CBP facilities, and the department has made some
progress in a very short period of time, I know, to reduce the
number of kids at these emergency sites.
But those sites do not provide the same level of care or
services that HHS's other facilities, and their extended use
really raises concerns. I wanted to ask you what is HHS doing
to phase out of these emergency sites as quickly as possible by
placing more kids into these State licensed facilities, and
with appropriate families and sponsors as soon and safely as
possible?
Secretary Becerra. Well, Senator, as you may have heard in
my discussion with Senator Hyde-Smith, we reach out to every
facility we can, in any part of the country. Because you're
right, while these emergency intake sites have done the job of
providing these kids with the care that you would expect, far
more than the Custom and Border Protection Service could, we
know that it's better to have them in a facility that is
licensed to provide that care.
There are any number of licensed facilities, but very few
of them we haven't already approached, and so, we're going
everywhere we can, and we have been able to expand the number
of licensed beds that have been available. There was a point
where we had more kids in emergency intake centers than we had
in licensed care facilities, when our census numbers were
really high. But we have now flipped that, and there are more
kids today in licensed care facilities than we have in these
emergency intake sites.
Senator Murray. Okay, and are you addressing the emergency
intake sites, and what are we doing there to improve the level
of care? Because they still do exist and will for a time.
Secretary Becerra. Substantial amount. Today, those intake
sites offer behavioral health services to kids, which we know
that is important for so many of these kids because they come--
--
Senator Murray. At all of the emergency intake sites?
Secretary Becerra. I think we have it at all of the sites
now. We do have behavioral health specialists who are there to
provide for their needs. We've always provided the medical
care. We were never sure when we first started standing up
these sites how long they would be around, and so, we made sure
we had the medical services. But getting behavioral health
specialists is obviously a little bit extra. It's a tougher
thing. But now, we do, because we've seen how we've had to open
a number of them.
We also now do discharge work. We actually do the process
of doing the intake, getting the information, doing the
background checks on potential custodians, sponsors. And that
wasn't done at the beginning either, because they were just
emergency intake sites to help us deal with the overflow.
But we've seen that so many of these kids would end up
staying in these sites for weeks, and so, we decided, no, let's
start doing the work now of finding a responsible sponsor that
can hold them, versus keeping them in one of these sites.
So, it's almost a full service--it is a full service. If
you go to Long Beach, California, not only is it a full-service
site, several hundred kids, but the community has so much
gotten involved that they ended up getting, and this was about
a month or so ago, 70,000 toys and books donated by the
community. Several hundred kids, but they got 70,000 gifts from
the community, which now is making it possible for us to send
some of these things to some of the other kids in some of these
other sites.
And so, it's a whole of agency approach, because we want to
make sure that we provide the right service. Again, I have to
acknowledge, this is expensive stuff. It is not easy. And we
are not going to let a child go to someone unless we feel
confident that they're going to be responsible caregivers. And
so, it's very difficult, but these are kids.
Senator Murray. Yes. Okay, thank you. Senator Blunt.
COVID-19 VACCINE GOALS
Senator Blunt. Thank you, Chair. Mr. Secretary, are we
going to reach the White House goal of 70 percent of all U.S.
adults with at least one shot by July 4, and for 160 million
Americans to be fully vaccinated by that date?
Secretary Becerra. I would not bet against this President,
Senator, because he's so far done a pretty good job of hitting
his marks, and I know he's determined, and we're working with
him to get to that 70 percent. But, quite honestly, it
shouldn't be just a goal of the President. It should be a goal
of every American to try to help us get to that 70 percent
threshold and beyond, because it's for the good of the people,
not just for the President.
Senator Blunt. Well, I agree with that. I guess we'll see
if there are enough donuts, and enough cans of beer, and
whatever else is being offered as the incentive to get people
to take that vaccine. It's really important to get this done,
and I hope we meet that goal. I'd be pleased if we exceeded it.
Who's taking principal responsibility for that?
Secretary Becerra. The President has thought it so
important that he established, even before he came into office,
this working group. Jeffrey Zients has been leading that group
for some time, and over the course, it's gone mostly from
trying to address to combat the pandemic and COVID-19, to now
making sure folks are getting vaccinated.
We're still doing all of the other things. But the major
focus has been now getting that vaccine out as best we can, and
I'm waiting for the invite, Senator, so that we can go to your
State and see the pockets that still have to get vaccinated,
and we'll do what we can.
Senator Blunt. Well, good. We'd be glad to have you, and
we're trying to do that. I think one of the lessons we learned
early on in this is you don't want to make it too complicated.
Hopefully, we won't face this situation again in a hurry, but
we might with the booster shots and, you know, the more people
that can, without wondering if they qualify, can line up and
get their vaccination, the better off we are, I think.
GRADUATE MEDICAL EDUCATION
I noticed in your budget submission that there is no
increase in children's hospitals graduate medical education. As
you know, that's the one part of medical education that's not
funded out of Medicare. We've made an increase every year in
the last 6 years. I hope you'll help us look at that again and
find an increase. There are accounts really close to that that
have increases. You know, if you don't have the opportunities
to go into children's hospitals and get your specialty that
way, you wind up going somewhere else, and I think we'd all
agree that we don't benefit from having a lack of people
focused on children's healthcare.
Secretary Becerra. GME (graduate medical education)
programs are critical. When I was in the House, I fought very
hard. LA obviously has a number of facilities, and at one
point, we almost lost MLK hospital in Los Angeles, which was
one of the safety net providers, and we fought really hard to
preserve the GME slots that we had for MLK, so that once it got
back into business, we'd still be able to bring in graduate
medical students, and so, I absolutely agree with you. We have
to do everything we can to try to increase the number of, and
supply of these doctors. Especially because, as you know, we
lack those physicians and in those specialties for children.
Senator Blunt. I'd like to figure out some way we could do
with children's medical education what we've done with all
other medical education for all other specialties. Maybe we can
work together and figure out if there is a way in some other
fund we could fund this like we fund everything else.
ACA/UNINSURED NUMBER
How many people--I know it was mentioned earlier that I
think 31 million people have insurance through the Affordable
Care Act. How many people do we believe don't have insurance
now?
Secretary Becerra. There are still probably tens of
millions. I don't want to give you a number off the top of my
head.
Senator Blunt. Will you get back to us with a number on
that?
Secretary Becerra. Absolutely.
Senator Blunt. I think when we started down this road a
decade ago, it was 30 million we thought didn't have insurance.
I'm afraid it's still about 30 million, but I'll let you take
that for the record.
Secretary Becerra. Will do, Senator.
Senator Blunt. Okay. Thank you, Chair.
Secretary Becerra. Thank you.
CHILDCARE
Senator Murray. Thank you. Mr. Secretary, the pandemic
really exposed what many of us have known for a very long time
that the childcare system in our country is really broken. And
childcare is just such an essential of our infrastructure. It's
really key to our economy, and during the pandemic, we saw four
times as many women leave the labor force as men, in large part
due to increased caregiving and distance learning
responsibilities. And the problem was even worse for Black and
Latina mothers.
So, I'm really glad to see your budget propose large
investments in childcare, including a $1.5 billion increase to
the Child Care and Development Block Grant. Prior to the
pandemic, CCDBG (Child Care and Development Block Grant)
programs served just one in seven eligible children, and the
need for the services is now expected to rise significantly
given the economic turmoil that's been created by this
pandemic.
So, talk to us about how this funding will improve access
to childcare.
Secretary Becerra. Madam Chair, you've said it. I mean, our
economy will not fully recover until we address the childcare
needs, especially for women, single women. And so, it is
important for us to make these kinds of investments. But it
still doesn't take us where we need to go. As you just
mentioned, just for those who were eligible, we were only
providing services to one in seven.
It's unfortunate that we look at it this way. Maybe it's
our tradition that we think that we could take care of our kids
ourselves, but today, that's not the reality. More often than
not, even if it's a two-parent household, both parents have to
work. And no one wants to see a scenario--I grew up being a
latchkey kid. No one wants to see a scenario where we damage
our future because we didn't think of investing in our kids.
The President's proposals to provide full-time pre-K for 3-
and 4-year-olds would be a tremendous help for a lot of
families. Providing the childcare tax credit that I know is
before you, a tremendous help. But investments in these block
grants that help those families is critical, especially for
middle and low-income families.
Senator Murray. Well, you know, there's a recent report
that showed nationwide the cost of childcare jumped, on
average, 47 percent during the pandemic. We now have people
trying to go back to work, and they're going, I couldn't afford
this before, now what am I going to do?
And another problem we're seeing is the wages for childcare
providers and early educators is abysmal, and yet these
operators are now trying to operate on extremely thin margins,
like everyone else. They can accept fewer kids, they have to
have all of the sanitation equipment. It is much harder to run
these businesses. So, I wanted to ask you how the budget
requests address the funding gap that now exists between what
parents can afford to pay and what high-quality childcare
providers need so they can operate?
Secretary Becerra. Madam Chair, probably the best way to
say it is this is what happens when you fail to invest for a
long time. It all starts to come at you, it hits you in your
face, and what we're finding is that the costs will continue to
increase, families will have a harder time, but quite honestly,
we should not be paying the dirt low wages that so many of
these childcare workers have been receiving. They deserve to be
paid for the work they do. They're taking care of our most
precious assets.
And so, we need to see them receive a decent wage and
salary, which will cost more in terms of the service for the
parents, but we have failed for so long to really invest in
taking care of our kids and helping our brothers and sisters in
America care for their kids that things are coming home to
roost. We have to make the investments. Fortunately, President
Biden wants to make those investments. I know that there's a
great deal of support in the House and in the Senate to do
something serious when it comes to childcare, whether it's the
tax credit or major direct investments, we need to do it,
because----
Senator Murray. Well, this is a top priority for me, and I
know it is for pretty much every working parent out there so,
we will work with you on that.
Secretary Becerra. Amen.
HEALTH DISPARITIES
Senator Murray. I wanted to ask you one last question. The
pandemic's deadly impact on communities of color really shows
that we have a long way to go to address systemic racism and
health inequities, and there's factors from housing to food
deserts to access to health services that can really have an
impact on somebody's health. So, I was really pleased to see
the budget focus on addressing those problems, including an
increase of $150 million for CDC's social determinates of
health activities. Can you talk a little bit about what those
initiatives will do to reduce health disparities?
Secretary Becerra. Madam Chair, the most important things
is that we're now recognizing--the fact that we're using the
words social determinants of health show how far we've come as
a Nation and as a policy-making body that we recognize that, in
so many ways, your health is determined by your background, too
often by your ZIP code, and we have to change those things,
because there are people in America who are left out. There are
places, the pockets in America where the services don't reach
them, whether it's rural America or whether it's inner-city
America.
And the President has made equity one of the prominent
features of his administration, and we will do the same at HHS.
Senator Murray. Well, thank you very much, and that will
end our hearing today. I do want to thank all of our fellow
committee members and Secretary Becerra for a very thoughtful
discussion today about the President's budget request and how
we can work together to really address some of these really
critical issues of lowering healthcare costs, and helping
families across the country get covered, address inequities,
respond to public health crisis, childcare. So much more that
is within your jurisdiction. So, really appreciate your
testimony today.
Secretary Becerra. Thank you.
ADDITIONAL COMMITTEE QUESTIONS
Senator Murray. For any Senators who wish to ask additional
questions, questions for the record will be due June 18 at 5
p.m. The hearing record will also remain open until then for
members who wish to submit additional material for the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted to Secretary Xavier Becerra
Questions Submitted by Senator Patty Murray
Question. The past year has been particularly devastating for
children and young adults' mental health. The CDC found the proportion
of emergency room mental health visits increased by a quarter from
April to October last year for children ages 5 and 11, and by nearly a
third for those between ages 12 and 17. Suicide attempts and
psychiatric help calls for children are also on the rise. Seattle
Children's Hospital in Washington is seeing 170 children with mental
health emergencies a week--compared to 50 before the pandemic. Sacred
Heart Children's Hospital in Spokane saw admissions to its adolescent
psychiatric unit and its pediatric floor for behavioral health issues
both rise by around 70 percent.
How does the budget request target mental health services
specifically to children and young adults?
How does the request address the ability for children to access
mental health services within their communities?
Answer. HHS is committed to providing mental health services that
address the needs of children and young adults. SAMHSA supports school-
based programming in part through Project AWARE (Advancing Wellness and
Resilience in Education). The purpose of this program is to build or
expand the capacity of State Educational Agencies, in partnership with
State Mental Health Agencies (SMHAs), to increase awareness, provide
training and promote connection to services for youth with behavioral
health needs. From October, 2016 to September, 2020, Project AWARE
trained over 56,000 providers and ensured that more than half a million
school-aged youth had access to and were referred to mental health
services.
School-based health centers (SBHC) are typically funded by U.S
DHHS-Health Resources and Services Administration (HRSA; https://
www.hrsa.gov/our-stories/school-health-centers/index.html) and/or by
individual State Departments of Health. SBHCs provide students with a
variety of age-appropriate health services, including, but not limited
to, primary medical care, health education, and nutrition education.
SBHCs are increasingly offering behavioral healthcare services such as
mental health and substance use screening, counseling, and case
management/referral services. SBHCs are often operated as a partnership
between the school and a community health organization, such as a
community health center (FQHC) or local health department; and for
behavioral health services, SBHCs often partner with local community
mental health centers.
SAMHSA has continued to expand the Certified Community Behavioral
Health Clinics (CCBHCs) through expansion grants, awarding 134 grants
in early 2021 through recent emergency funding, with up to 74
additional grants being awarded in summer of 2021 as part of the
regular appropriations process. 166 CCBHC grantees were awarded in
fiscal year 2020. SAMHSA is also planning a formal technical assistance
arrangement to support organizations in implementation and
sustainability. The CCBHC programs provide an array of critical,
integrated services to meet the behavioral health needs of communities.
CCBHCs provide a full continuum of timely, person and family-centered
services, including access to crisis services 24/7, and are
particularly focused on the needs of individuals with serious mental
illness (SMI), serious emotional disturbance (SED) and/or substance use
disorder (SUD). The program is designed to support individuals and
families who are uninsured or underinsured and who may otherwise lack
access to effective screening and treatment. The program encourages use
of telehealth and other modalities to increase reach of services and to
address barriers to care access.
Question. The fiscal year 2021 Labor-HHS bill included a new, 5
percent set aside in the Mental Health Block Grant for states to
develop crisis systems to improve their ability to respond to
individuals experiencing a mental health crisis. These systems are
intended to connect people with appropriate services, rather than
referring them to law enforcement or emergency rooms.
How does the request build on the crisis response set aside created
in the fiscal year 2021 bill and how does HHS plan to work with states
to ensure these systems are fully accessible with adequate coordination
between mental health and law enforcement?
Answer. The Community Mental Health Services Block Grant received
an increase of $825 million in the fiscal year 2022 President's Budget,
for a total of $1.6 billion, to expand access to behavioral healthcare.
Within the total, $75 million is directed to the crisis services set-
aside. This investment in crisis services will direct funding to states
to build much needed crisis systems that will provide high quality,
expeditious mental healthcare. This funding also will support the
partnering of behavioral health providers with law enforcement.
SAMHSA has been actively engaging with states on the use of MHBG
funds, including this crisis set-aside ($75 million in fiscal year 2022
President's Budget). This coordination has included technical
assistance on the use of funds, requests for information on specific
allocations of funding across the crisis continuum of care, and
recommended changes to the data reporting system. States are at
different stages in their implementation of core crisis services and
currently use the funds to expand existing core services or develop new
services. Funding regional or statewide crisis centers is an allowable,
but not required, use of the funds. There is significant variation in
the degree to which states are using MHBG funds to support activities
such as the Lifeline crisis call centers. The fiscal year 2022
President's Budget includes funds for SAMHSA to further expand the
capacity of the call centers to ensure they can respond to the expected
increase in call volume accompanying the transition to 988.
Beyond the current Lifeline functionality, it is critical that
individuals experiencing a behavioral health emergency have access to a
coordinated crisis system of care. Effectively responding to people in
crisis who are experiencing a behavioral health emergency has three
main components as outlined in SAMHSA's National Guidelines for
Behavioral Health Crisis Care: providing someone to talk to, providing
in-person response, and providing a place to go. Implementing 988
successfully will be a critical first step in the crisis response.
Current research suggests that many crises can be effectively addressed
through a call alone. In addition, call centers that have follow-along
capacity and/or access to local outpatient treatment resources can
provide enhanced crisis care. A robust crisis system, including 988
access through the Lifeline network, will decrease suicides, reduce
arrests and criminal justice involvement for individuals with
behavioral health needs, and will facilitate linkages to care to reduce
unnecessary emergency department boarding and hospitalization.
Implementation of the Lifeline, partnered with the development of a
coordinated and comprehensive behavioral health crisis services system
across the United States, will save lives.
The fiscal year 2022 President's Budget further supports local
communities in meeting the mental health needs of people who are
incarcerated by investing $45 million more in these programs for a
total of $51 million to support the needs of those who are involved in
the criminal and juvenile justice system(s) providing funding for
partnerships between mental health providers and law enforcement.
SAMHSA will award a new cohort of grants to community-based behavioral
health providers that focus specifically on the delivery of mental
disorder treatment while in jail and provide linkages to care post-
incarceration.
Question. The President's budget request includes a $77.6 million
increase for the National Suicide Prevention Lifeline in order to help
build the infrastructure necessary to make a smooth transition to the
new three-digit code (9-8-8) as required by the National Suicide
Hotline Designation Act.
Please describe how this funding will strengthen the existing
infrastructure of the Lifeline and better prepare local centers to
respond to the increase in calls expected once the transition to 9-8-8
occurs.
Answer. The creation of 988 is a once-in-a-lifetime opportunity to
strengthen and expand the Lifeline and transform America's behavioral
health crisis care system to one that saves lives by serving anyone, at
any time, from anywhere across the nation. Preparing the Lifeline for
full 988 operational readiness will require a bold vision for a system
that provides direct, life-saving services to all in need and links to
community-based providers uniquely positioned to deliver a full range
of crisis care services. SAMHSA sees 988 as the linchpin and catalyst
for a transformed behavioral health crisis system in much the same way
that, over time, 911 spurred the growth of emergency medical services
in the United States.
SAMHSA envisions a multi-phase approach to making 988 operational
and effective. SAMHSA is committed to using this investment to
strengthen the existing infrastructure and prepare for the launch of
988. The first phase is focused on increasing the capacity and
operational readiness for the National Suicide Prevention Lifeline to
accept 988 calls, chats, and texts by July of 2022. This includes
support to ensure a national back-up system or safety net. SAMHSA has
reviewed modeling estimates to anticipate the expected call volumes
with 988 rollout. The President's Budget includes funds to support the
resources needed for network and telephony infrastructure expansion,
training to harmonize protocols across all local centers, and staffing
to increase the capacity of the Lifeline to respond to the anticipated
increase in calls expected with the 988 transition.
An ideal crisis system would include state and regional crisis
hubs, which can be fully integrated with mobile crisis response, crisis
receiving facilities and follow up care. SAMHSA believes that the
crisis system will be critical to make 988 optimally effective in
addressing behavioral health crisis needs and reducing unnecessary
hospitalizations and law enforcement involvement.
Question. The budget request notes that this funding will be used
to increase the capacity to respond to text messages and to those who
need specialized services. Does the Department plan on leveraging
existing infrastructure rather than recreating these capabilities?
Answer. Yes, leveraging existing infrastructure will be
instrumental in the success of 988. Initially established by Congress
in 2005, the Lifeline is a national network of over 180 independently
operated crisis call centers, three Spanish language centers, and the
Veterans Crisis Line (VCL). The network is currently linked by the
toll-free telephone number, 1-800-273-TALK, which is available 24 hours
a day, 7 days a week. The Lifeline network also consists of 9 national
backup and 38 chat/text centers. The backup and chat/text core network
centers operate under contractual obligations through the Lifeline
Administrator, who oversees the current Lifeline cooperative agreement
from SAMHSA.
Until recently, funding for the National Suicide Prevention
Lifeline was only $7 million. This funding along with limited state
investments has been insufficient to pay local centers to answer
Lifeline calls. With the President's Budget request, as well current
state investments in the answering of Lifeline calls, important
progress is being made.
It is critical to invest in strengthening Lifeline network
operations. While further system transformation will require additional
capacities (e.g., substance use integration, coordination across the
crisis continuum, etc.), the immediate priority is ensuring the
Lifeline has sufficient resources to address the scope of contacts
addressed directly in the National Suicide Hotline Designation Act,
including individuals in suicidal or mental health crisis. In the near
term, efforts should be made to map available local resources so that
facilitated transfers and referrals can be made to support individuals
with additional needs.
SAMHSA recognizes the need for a multi-pronged approach to address
the needs of populations at higher risk of suicide. This includes both
leveraging existing technologies as well as piloting and developing
novel approaches to enhance access to crisis care.
Question. When does the Department intend to provide the
Subcommittee with the report on the costs associated with a transition
to 9-8-8?
Answer. SAMHSA has been working diligently on three important
reports to Congress--the 988 Appropriations Report, the Report on
Training and Access to 988 for High Risk Populations, and the Report on
988 Resources. SAMHSA worked collaboratively with the VA to develop the
Resources report to Congress. All three reports are in the final stages
and will be submitted to the respective Committees and your
Subcommittee shortly.
Question. The pandemic's impact on child-care has been especially
hard on communities of color, undermining parents' economic stability
and children's school readiness. Virtually all child-care workers are
women, disproportionately women of color and immigrant women who do not
receive adequate wages or benefits. COVID has only made these
inequities worse. Additionally, even before the pandemic, children of
color were less likely to attend a high- quality early learning program
than their white peers, and entered kindergarten 9 months behind their
white non-Hispanic peers in math and almost 7 months behind in reading,
on average. Furthermore, Center closures because of the pandemic have
threatened an already limited supply of care for infants and toddlers
and made it even harder for families of color to get quality,
affordable child-care. I am concerned these closures will deepen racial
and socioeconomic inequities in access to high-quality early learning
opportunities that promote kindergarten readiness for children.
What role is HHS playing in addressing the racial inequities in
child-care for families and providers?
Answer. The HHS Office of Child Care (OCC) is providing guidance,
technical assistance, and oversight to assist states, tribes, and
territories with administering the multiple rounds of COVID-19 child
care supplemental funding, including the $39 billion in child care
funding provided by the American Rescue Plan Act consisting of $24
billion in child care stabilization funds and $15 billion in
supplemental Child Care and Development Fund (CCDF) awards. This
funding is helping to stabilize and improve the child care sector and
improve access for all children and families, including addressing
racial and ethnic inequities.
The American Rescue Plan Act child care stabilization funds are
providing immediate financial relief to child care providers facing
increased costs and declining revenue. Our guidance on these funds
(Information Memorandum CCDF-ACF-IM-2021-02) indicates that
applications, technical assistance, and written resources should be
available in multiple languages, and that states are encouraged to work
with culturally relevant organizations to meet the ongoing needs of
providers receiving grants. We are also collecting data on the race,
ethnicity, and location of child care providers to track the equitable
distribution of resources.
The CCDF supplemental funds in the American Rescue Plan Act are an
unprecedented opportunity to expand access to high-quality child care
and move toward a more equitable child care system by assisting many
families and providers who have not previously participated in the
child care subsidy system--including families and providers from
communities of color. Our guidance (Information Memorandum CCDF-ACF-IM-
2021-03) strongly recommends that states prioritize increasing provider
payment rates and workforce compensation so that child care providers
can retain a skilled workforce and deliver higher-quality care to
children receiving subsidies. These steps will advance equity for
women, particularly women of color, lift families out of poverty, boost
the broader economy, increase women's labor force participation, and
improve outcomes for children. Our guidance also encourages states to
pursue opportunities to build the supply of child care--including the
use of grants and contracts--for historically-underserved populations.
The guidance also encourages states to use some of the funds for
outreach activities to underserved populations, including to
disseminate materials in multiple languages, and to fund partners and
organizations trusted by families and child care providers--including
culturally relevant organizations.
OCC has developed a number of technical assistance (TA) resources
to help state, territory, and tribal CCDF administrators and other
systems-level professionals assess and ensure equitable child care
service delivery to racially disadvantaged communities. These resources
encompass all child care settings, e.g., center-based care, family
child care, and family, friend, and neighbor care; as well as the range
of age groups served by CCDF. Our TA system embeds racial equity
considerations in the planning, development, and evaluation of new
resources to ensure they are inclusive of diverse perspectives and
responsive to disadvantaged community's needs.
--The National Center on Early Childhood Quality Assurance (ECQA) has
developed resources on considerations for leadership in early
childhood systems development and for child care licensing
systems, as well as other health equity resources to help
grantees develop integrated strategies to support the social
and emotional wellness of children by highlighting promising
strategies used by CCDF grantees. See for example Kickoff:
Office of Child Care Initiative to Improve the Social-Emotional
Wellness of Children and A Resource Guide for Developing
Integrated Strategies to Support the Social and Emotional
Wellness of Children.
--Our TA Center for the Preschool Development Grants, Birth to Five
(PDG B-5)--which supports early childhood systems development,
including child care--recently delivered a webinar on building
state capacity to consider equity in data collection,
specifically administrative data, to improve equitable access
and outcomes through data collection and analysis. The Center
also developed a research to practice brief that highlights
current research trends and implications for racial and ethnic
disparities related to early childhood, including policy
choices to reduce disparities and set children and families on
more favorable trajectories. TA website users have demonstrated
a strong interest in this equity content and it is among the
PDG B-5 TA Center's most popular links: https://
childcareta.acf.hhs.gov/improving-equity-services.
--In recognition of the disproportionate impact of the COVID-19
pandemic on indigenous communities, OCC has made a focused
effort over the last year to identify ways to support Tribal
CCDF programs' response and recovery. Understanding that
cultural connection is a strength and resiliency factor in
tribal children and families, the National Center on Tribal
Early Childhood Development (NCTECD) has developed a number of
resources to support grantees with culturally relevant quality
improvement activities, including resources focused on CCDF
quality requirements; ideas and innovations for quality
improvement activities that meet community needs; support with
planning, including prioritization and budgeting; and
developing clear and strong policies and procedures. See
https://childcareta.acf.hhs.gov/quality-improvement- resource-
page.
In addition, our TA providers regularly refer states and other TA
recipients to resources published by national organizations (such as
the Annie Casey Foundation and Child Trends) that center racial equity
in the development and implementation of child care policies and
practices. These resources are used in the provision of intensive/
individualized, targeted/group, and universal TA strategies depending
on grantee need and readiness.
Looking ahead, the Biden-Harris Administration's Build Back Better
vision for early childhood would add substantial ongoing investments to
early learning services and infrastructure and continue the momentum
created by the American Rescue Plan Act--to benefit all children,
families and providers--including in communities of color. The
President's fiscal year 2022 Budget includes $250 billion over 10 years
to make child care affordable and to modernize and expand child care
facilities. High-quality early care and education opportunities lay a
strong foundation so that children can take full advantage of education
and training opportunities later in life. The President's Build Back
Better invests in child care infrastructure and workforce training and
ensures that low and middle-income families pay no more than 7 percent
of their income on high-quality child care. The Build Back Better also
proposes $200 billion for a national partnership with states to offer
free, high-quality, accessible, and inclusive prekindergarten to all
three- and four-year-olds. The proposed universal prekindergarten
program is designed to give states incentives to build out their
existing pre-k programs to reach more 3- and 4 -year-olds and to
increase program quality by building on what has already been
established in states. The Budget also proposes increased funding
levels for existing early care and education programs, including nearly
$11 billion for CCDF and a total of $11.9 billion for Head Start.
Question. Title X is the only Federal program dedicated to
providing family planning services for people who are paid low incomes.
It disproportionately serves communities of color, where the pandemic
has hit the hardest and exposed sharp disparities in access to care.
Sadly, this critical program has been chronically underfunded for too
long. The President's Budget proposes to increase the program by $54
million, its first increase in nearly a decade. Yet, research shows
Title X would need hundreds of millions more annually to provide family
planning services to all women without insurance and who are paid low
incomes in the United States.
Please explain how HHS plans to use this increase to help increase
access for women of color and women who are paid low incomes?
Answer. HHS agrees the nation must take swift action to prevent and
remedy stark racial and ethnic disparities in health and healthcare
delivery in America, including advancing equity and reducing health
disparities in all healthcare programs. As you noted, the budget
provides a 19 percent increase to the Title X Family Planning program
for a total of $340 million to support family planning services for
approximately 3.5 million persons, with approximately 90 percent having
family incomes at or below 200 percent of the Federal poverty level and
a disproportionate number of clients served identify as a person of
color. The Office of Population Affairs (OPA), part of the Office of
the Assistant Secretary for Health (OASH), advises the HHS Secretary on
a range of public health priorities including quality family planning
and adolescent health and serves as a key stakeholder on HHS' effort to
advance health equity.
OPA administers the Title X family planning program, the only
Federal program devoted solely to the provision of family planning and
related preventive healthcare. By law, under the Title X program,
priority is given to individuals from low-income families, which
include many communities of color. On January 28, 2021, President Biden
issued a ``Memorandum on Protecting Women's Health at Home and Abroad''
directing the Department to review the 2019 Title X Final Rule and
``consider, as soon as practicable, whether to suspend, revise, or
rescind, or publish for notice and comment proposed rules suspending,
revising, or rescinding, those regulations, consistent with applicable
law, including the Administrative Procedure Act.'' The memorandum
specifically directed the Department to ensure that undue restrictions
are not put on the use of Federal funds or on women's access to medical
information. After reviewing the 2019 rule, the Department went through
notice-and-comment rulemaking and finalized a regulation to revoke the
2019 rules and restore the 2000s regulation that successfully guided
the program for decades with several modifications needed to strengthen
the program and ensure access to equitable, affordable, client-
centered, quality family planning services for all clients.
Question. Chairman Pallone and I recently wrote a letter to
interested parties requesting input on how best to write legislation
establishing a public health insurance option. The objective is to
create a strong Federal public option that makes healthcare more
accessible, more affordable, and simpler for patients and families. In
addition to policies like permanently extending the increased premium
tax credits in the American Rescue Plan, a public option would go a
long way towards ensuring every person has quality, affordable coverage
regardless of income, age, race, disability, or zip code. We were
pleased that the budget expressed the President's support for a public
option available through the ACA marketplaces.
How would a public option help expand coverage, bring down
healthcare costs, and make healthcare easier to access for patients and
families?
Answer. The President supports providing Americans with additional,
lower-cost coverage choices by creating a public option that would be
available through the ACA marketplaces and giving people age 60 and
older the option to enroll in the Medicare program with the same
premiums and benefits as current beneficiaries, but with financing
separate from the Medicare Trust Fund. . President Biden has been clear
that his goals for improving the American healthcare system begin with
building on the successes of the Affordable Care Act, and HHS is
committed to working toward that goal.
Question. The Affordable Care Act (ACA) authorized $30 million for
Consumer Assistance Programs (CAPs) to provide a dedicated Federal
funding stream to help health insurance consumers effectively steer
their way through our nation's complex health insurance system and to
avail themselves of new consumer protections in the ACA. In 2010, HHS
awarded nearly $30 million in CAP grants to 40 states, territories, and
the District of Columbia. Regrettably, efforts to overturn and then
weaken the ACA resulted in blocking additional funding after the first
year. Many states--including New York, Massachusetts, Maine,
Connecticut, Rhode Island, Vermont, the District of Columbia, Maryland
and more--maintained CAPs with limited state funds, but others closed
altogether for lack of funding. These programs help consumers
understand and use their insurance plans, resolve medical billing
problems, and appeal insurance denials. As the Biden Administration
joins Congress to provide support to individuals who are underinsured
or who have lost their jobs and healthcare coverage due to the economic
downturn caused by the COVID-19 pandemic, assistance is needed to help
consumers navigate and understand their healthcare options.
Does the Administration support the resumption of the ACA CAP
programs to sufficiently meet the demand for such assistance?
How does the Administration plan to prioritize the provision of
services provided in the CAP programs to people across the nation?
Answer. HHS is committed to using all available tools to strengthen
the ACA Marketplaces, making it easier for people to get and keep
health insurance, and making sure more Americans know about their
options and are supported in their enrollment.
Question. In December 2018, the bipartisan 21st Century IDEA (PL
115-336) was signed into law. It requires agencies to modernize their
websites, intranets and digitize their paper-based forms with the goal
of improving the Federal Government's customer experience and digital
service delivery. Since Congress passed the 21st Century IDEA, the
nature of how individuals engage with the government has fundamentally
changed--in large part because of the COVID- 19 pandemic. These changes
underscore an even stronger need to implement the 21st Century IDEA and
allow Federal agencies to deliver an excellent customer experience from
anywhere, to anyone, on any device.
Has CMS fully implemented the 21st Century IDEA Act (Public Law No:
115-336)? What barriers has CMS faced in implementing this law and
modernizing its digital services?
The law required each executive agency to digitize and ensure any
paper- based form was made available to the public in a fully usable
mobile friendly option. Where does CMS stand in ensuring its forms can
be filled out and submitted electronically on all digital devices?
Who is responsible inside CMS for ensuring the agency fully
implements PL 115-336?
Answer. CMS is committed to making sure beneficiaries, enrollees,
providers, and other stakeholders have access to the information they
need to make important decisions about their healthcare. The 21st
Century IDEA provided CMS with valuable resources and guidance that
bolstered its ongoing efforts to modernize its websites. CMS has
implemented the 21st Century IDEA for all of its public websites, and
many CMS forms are available for beneficiaries, enrollees, providers,
and other stakeholders to fill out and submit online. The CMS Office of
Communications continues to make updates that make it easier to access
and submit these forms from a mobile device.
Question. HRSA's C.W. Bill Young Cell Transplantation Program,
along with its nonprofit partner the National Marrow Donor Program
(NMDP), provides support and access for patients who need lifesaving
bone marrow transplants. The President's budget request proposes to
combine the Cell Transplantation/National Registry Program with the
National Cord Blood Inventory (NCBI) Program. It also appears to
request an increase of $7 million for the Cell Transplantation/National
Registry Program.
Please provide greater detail than what was included in the HRSA
Congressional Justification (CJ) on the proposed consolidation and how
HHS plans to spend the proposed increase.
Answer. In fiscal year 2022, HHS will use approximately $49.2
million in consolidated funds from the C.W. Bill Young Cell
Transplantation Program (CWBYCTP) and the National Cord Blood Inventory
(NCBI) to support the common legislative and therapeutic functions of
both programs (i.e. bone marrow functions, cord blood functions, single
point of searching access, stem cell therapeutic outcomes database, and
patient advocacy) outlined in the TRANSPLANT ACT of 2021.
In fiscal year 2022, HHS expects to award approximately $10 million
to licensed cord blood banks to continue banking high-quality, diverse
cord blood units. HHS also plans to provide approximately $7 million to
examine ways to optimize cord blood utilization. The remaining $32.2
million will support the five legislative functions described above
through one or more contracts. HHS will obligate these funds primarily
for contract-supported initiatives (i.e. adult donor recruitment and
tissue typing, searches for stem cell sources through a single point of
electronic access, patient education, case management, donor advocacy,
public outreach, professional development, and data collection). HHS
will use a small portion for administrative costs.
Question. In addition, this Committee provided increases for this
program in both fiscal year 2200 and fiscal year 2021, yet the CJ
includes little detail on how HRSA plans to use these resources. Please
provide execution detail for each of these fiscal year increases and
the total amount that was obligated and applied to HRSA's partners who
run the program.
Answer. In fiscal year 2020, HRSA provided an increase in funding
to support new and existing activities under the Single Point of
Access-Coordinating Center contract. The activities for the Office of
Patient Advocacy and Stem Cell Therapeutic Outcomes Database contracts
remained unchanged. The funding provided for each CWBYCTP contractor is
outlined below:
--National Marrow Donor Program--
--Single Point of Access-Coordinating Center (SPA-CC)--$21.8
million used to support the SPA-CC contract, which carries
out three legislative functions (i.e., bone marrow, cord
blood, single point of access);
-- This funding included an additional $5.4 million, which
increased existing support for adult donor recruitment and
tissue typing; high-resolution tissue typing of cord blood
units and collaboration with cord blood banks to enhance
cord blood operations. The funding also supported new
activities under the contract, including: cytomegalovirus
testing of adult donors; COVID-19 related increases
including donor and courier costs; and cryopreservation of
blood stem cell products.
--Office of Patient Advocacy (OPA)--$877,000 used to support the
Office of Patient Advocacy; and
--Medical College of Wisconsin's Center for International Blood and
Marrow Transplant Research--
--Stem Cell Therapeutic Outcomes Database--$4.6 million used to
collect outcomes data on blood stem cell transplants using
bone marrow and cord blood.
In fiscal year 2021, HRSA plans to fund existing and enhanced
activities carried out by the following CWBYCTP contractors:
--Single Point of Access-Coordinating Center (SPA-CC)--$29.8 million
used to support the SPA-CC contract.
--HHS will fund many of the same activities, including adult donor
recruitment and tissue typing, high-resolution tissue typing of
cord blood units, and collaboration with cord blood banks.
Also, HHS will fund donor advocacy and contingency planning
activities.
--The additional $7 million will support existing NCBI cord blood
banks; raise physician awareness of all cellular therapy
treatment options, including cord blood; and support
engagement with the cord blood community.
--Office of Patient Advocacy (OPA)--$903,000 used to support the
patient advocacy and case management. The scope for this
contract has not increased in recent years.
--Stem Cell Therapeutic Outcomes Database--$4.7 million used to
collect outcomes data on blood stem cell transplants using bone
marrow and cord blood. The scope for this contract has not
increased in recent years.
Question. The Committee included language in the fiscal year 2021
Conference Agreement that encouraged HHS to ``review the accreditation
and eligibility requirements for the Public Health Service Corps and
behavioral health workforce programs to allow access to the best
qualified applicants, including those who graduate from Psychological
Clinical Science Accreditation System (PCSAS) programs''. This review
and these changes are necessary to update Department policy that was
adopted prior to the establishment of PCSAS to permit the graduates of
the current 44 PCSAS University accredited doctoral programs in
psychological clinical science to be eligible to compete.
Please provide an update on progress to update these Department
policy and regulation.
Answer. As of December 2020, the Public Health Service Commissioned
Corps includes the Psychological Clinical Science Accreditation System
programs in the Category Specific Appointment Standards. This means
that individuals with such accreditation are permitted into the Corps.
HRSA is currently exploring options to include PCSAS doctoral
programs as eligible entities in the upcoming fiscal year 2022 Graduate
Psychology Education competition. HRSA will continue to explore options
to include such programs in other future competitions, including, but
not limited to, the Behavioral Health Workforce Education and Training
program, and the Geriatric Academic Career Awards. HRSA currently
anticipates posting the Notice of Funding Opportunity for the Graduate
Psychology Education program in November 2021.
Question. The Centers for Medicare & Medicaid Services (CMS) posted
a final rule for Medicare's radiation oncology alternative payment
model (RO APM) on September 18, 2020. Implementation of the model has
been delayed by Congress until January 2022.
Is the Biden Administration reviewing and planning to issue an
updated RO APM?
Will HHS commit to working with both Congress and stakeholders to
improve the RO APM and ensure that a transition to new value-based
models does not result in reduced patient access to innovative cancer
treatments?
Answer. Since 2014, CMS has explored potential ways to test an
episode-based payment model for radiotherapy (RT) services. In December
2015, Congress passed the Patient Access and Medicare Protection Act,
which required the Secretary of Health and Human Services to submit to
Congress a report on ``the development of an episodic alternative
payment model'' for RT services. The report was published in 2017 and
identified three key reasons why RT is ready for payment and service
delivery reform: the lack of site neutrality for payments; incentives
that encourage volume of services over the value of services; and
coding and payment challenges.
The Radiation Oncology (RO) Model, implemented through the CMS
Innovation Center, aims to improve the quality of care for cancer
patients receiving RT and move toward a simplified and predictable
payment system. The RO Model tests whether prospective, site neutral,
modality agnostic, episode-based payments to physician group practices,
hospital outpatient departments, and freestanding radiation therapy
centers for RT episodes of care reduces Medicare expenditures while
preserving or enhancing the quality of care for Medicare beneficiaries.
I am happy to work with Congress and other stakeholders to address any
concerns about this model.
The Consolidated Appropriations Act, 2021 enacted on December 27,
2020 included a provision that prohibits implementation of the
Radiation Oncology Model prior to January 1, 2022, effectively delaying
the start date by at least 6 months. CMS intends to address the delay
and make other modifications to the RO Model through notice and comment
rulemaking.
Question. Analysis of CDC data and other reports indicate a
reduction in routinely recommended vaccination of children and youth
last year resulting from the disruption to routine healthcare caused by
the COVID-19 pandemic. Lack of proper vaccinations could provide an
additional challenge to the return to in-person learning in the fall.
How is HHS working with the Department of Education to support the
vaccination of children and youth needed for school enrollment for in-
person learning?
Answer. CDC issued a Call to Action in April 2021 encouraging
healthcare providers to identify and follow up with families whose
children have missed doses, and to schedule appointments for those
children. CDC encouraged schools and state and local government
agencies to use the state's immunization information system's reminder-
recall capacity to notify families whose children have fallen behind on
routine vaccines and encourage compliance with vaccination
requirements. In June 2021, CDC issued an MMWR article describing the
decrease in routine childhood and adolescent immunizations in 10 U.S.
jurisdictions during March-September 2020 as compared with the same
period in 2018 and in 2019.
______
Questions Submitted by Senator Richard J. Durbin
Question. Secretary Becerra, the budget proposes $767 billion for
Medicare. One of the greatest drivers of outlays by the Medicare
program is the cost of chronic conditions, including tobacco-related
costs. By some estimates, 10 percent of Medicare spending is
attributable to smoking and the health harms it causes. So it would
seem that the Department would want to be doing everything it can to
prevent tobacco use, especially among youth. As you know, youth e-
cigarette use has skyrocketed over the past decade. Four million kids
are now vaping--one in every five high school students.
And for years, the Federal Government failed to regulate these
addictive, kid-friendly products. Nine months ago, e-cigarette
companies were required to submit applications to the FDA in order to
stay on the market. This is a momentous time for the FDA, as it will
evaluate whether these e-cigarettes are ``appropriate for the
protection of public health.'' That is a high bar. But the FDA's
priority should be protecting our youth and preventing a lifetime of
addiction. I am deeply concerned that the FDA will let a product such
as JUUL--which has partnered with Marlboro-maker Altria and had a
years-long documented campaign of hooking our kids on nicotine--to
remain on the market. In particular, I am worried that FDA will allow
flavored products--which we know are meant to target kids--to
proliferate.
Can you commit to me that HHS and FDA will not authorize any vaping
products that will lead to more youth use, including flavored products?
Answer. FDA has a very important responsibility to review new
tobacco products before they can be legally marketed. FDA determines if
a new tobacco product may be legally marketed by assessing whether the
marketing of the product meets the applicable standard Congress set in
the law to protect the public health.
As required by statute, a key consideration in our review of
premarket tobacco product applications submitted for products like e-
cigarettes is to determine whether permitting the marketing of the
product would be ``appropriate for the protection of the public
health,'' taking into account the risks and benefits to the population
as a whole. This determination includes consideration of how the
products may impact youth use of tobacco products and the potential for
the products to completely move adult smokers away from use of
combustible cigarettes. Importantly, we know that flavored tobacco
products are very appealing to young people. Therefore, assessing the
impact of potential or actual youth use is a critical factor in our
determination as to whether the statutory standard for marketing is
met.
Looking forward, FDA continues to work expeditiously to complete
review of the remaining pending applications. While the Agency cannot
prejudge applications or categorically deny marketing authorization
based on certain characteristics, such as flavors, be assured that HHS
and FDA share your concern about youth initiation and use of tobacco
products, and we will continue to keep you updated as reviews continue.
Question. Two decades ago, a CDC study came out that changed the
way we think about public health. It was called the Adverse Childhood
Experiences or ``ACEs'' study, and it established the link between
exposure to trauma--things like witnessing violence or an overdose--and
our long-term health, education, and economic outlook. We now
understand how trauma and ACEs harm brain development, and how these
emotional scars can lead to lower life expectancy, and a higher
likelihood of suicide or drug use.
When you look at the public health crisis of gun violence--along
with the mental health and addiction--it's clear we must focus on the
root issue of trauma. So Senator Capito and I teamed up in 2018 to pass
legislation that created an ACEs program at CDC, and I am pleased to
have secured $10 million over the past 2 years for this work. We also
passed provisions creating the Interagency Task Force on Trauma-
Informed Care that brings our Federal agencies around the table to
promote this understanding of trauma in every Federal grant program,
increasing the authorization for the National Child Traumatic Stress
Network, and authorizing a $50 million trauma and mental health
services grant program for schools, which we have not yet been able to
fund. This grant program--Section 7134 of the SUPPORT for Families and
Communities Act--would assist schools in adopting trauma-informed
practices, training more staff, engaging families, and forging
partnerships with clinical mental health professionals.
Now, the 2022 budget proposes a $61 million increase to SAMHSA's
Project AWARE mental health funding, and a $100 million investment at
CDC in community-based violence interventions, working with
neighborhood organizations and hospitals to deliver services. Chicago
is home to many of these programs--including street outreach efforts,
trauma programming in schools, and hospital programs that pair victims
of violence with social workers to address their trauma and reduce the
current 50 percent re-injury rate.
Secretary Becerra, can you explain how this new CDC community-
violence proposal can support programs like those in Chicago, and how
you envision this constellation of programs working together?
Secretary Becerra, in addition to, or as part of, the proposed
increase to Project AWARE, would you also support appropriations for
this already-authorized Sec. 7132 program to address the breadth of
trauma needs in schools--setting up comprehensive plans, trainings, and
partnerships?
Answer. The Community Violence Initiative (CVI) proposal would help
CDC address the root causes of community violence and support systemic
approaches to violence prevention. CDC would prioritize implementing
evidence-based, community strategies to reduce rates of violence;
expand our prevention data surveillance, conduct research to address
critical gaps; and enhance what is known about what works to prevent
community violence. This approach includes prevention strategies that
address the structural determinants of health that contribute to
violence inequities within and across communities, such as those
currently implemented in Chicago. In addition, Hospital-Community
Partnerships, such as HEAL, represent an important type of strategy to
prevent and reduce community violence and could be supported under the
proposed Community Violence Initiative.
A comprehensive approach is critically important to achieving and
sustaining long-term reductions in community violence. A strong and
growing research base demonstrates that there are multiple prevention
strategies that are scientifically proven to reduce violence
victimization and perpetration. Many of these strategies are upstream
approaches that have yielded community savings that far outweigh
implementation costs. These upstream approaches, coupled with programs
like hospital-community partnerships, can create safe, healthier, and
more resilient communities.
In addition to funding 25 cities with the highest overall number of
homicides and the 25 cities with the highest number of homicides per
capita, the CVI proposal would also fund up to five non-governmental
organizations that have expertise in partnering with communities most
impacted by community violence. Doing so will build a network of
violence prevention efforts, from local health departments to community
organizations. The CVI proposal will also help modernize data systems
like the National Violent Death Reporting System (NVDRS) to provide
more timely data on causes of violence in communities.
SAMHSA is also committed to effective school based mental health
services that address the needs of children and families. Project AWARE
grantees have established mechanisms to provide tiered services in
school settings. This tiered system has three main components. One pays
attention to the overall school climate and promotes social and
emotional learning opportunities and supports for all children. The
next tier has special programming for children at risk for the
development of behavioral health conditions. The third and final tier
is comprehensive services for children and their family with serious
emotional disturbance (SED). A comprehensive approach to behavioral
healthcare in schools is critical to build resilience in our children
and youth include building trauma-informed school systems and providing
training and community partnerships in trauma-informed care. Building
in trauma-informed care to AWARE projects and augment that work with
additional partnerships to address the breadth of need in schools is
critical to meet the mental health needs of our children and youth.
Several programs funded by HRSA are focused on measuring and
addressing the impact of ACEs, as well as providing trauma-informed
care in schools.
national coordinating committee on school health and safety
HRSA in collaboration with CDC leads the National Coordinating
Committee on School Health and Safety (NCCSHS) to support student well-
being and ensure school facilities are healthy and safe environments.
Since its inception in 1996, NCCSHS aims to support communication among
governmental agencies and national non-governmental organizations in
order to share resources and disseminate information about school
health and safety to local and state partners. NCCSHS members are
working to coordinate communication and encourage uptake at the state/
local levels of school-based approaches that protect student's mental
health and well-being through expanding comprehensive, trauma-informed
mental health services in schools and the Whole School, Whole
Community, Whole Child model (WSCC). NCCSHS includes 170 members
including eight Federal agencies and non-governmental organizations
such as the American Academy of Pediatrics, American Psychological
Association, and Council of Chief State School Officers.
collaborative improvement and innovation network for school-based
health services
The Collaborative Improvement and Innovation Network for School-
Based Health Services (CoIIN-SBHS) provides trauma-informed, behavioral
health technical assistance to state partners (e.g., Title V Maternal
and Child Health programs, state Medicaid programs, child mental health
agencies, education agencies, state-level non-profit organizations),
school districts, comprehensive school mental health systems and
school- based health centers. This program is in its fifth of 5 years
of funding and is administered by the School Based Health Alliance in
partnership with the National Center for School Mental Health.
adverse childhood experiences (aces) in primary care settings
demonstration project
The newly awarded Adverse Childhood Experiences (ACEs) in Primary
Care Settings Demonstration Project will study how best to implement,
in primary care settings, screening protocols and evidence-based
interventions for children and adolescents who have experienced ACEs.
The goal of this program is to yield a model for integrating ACEs
screening and strength-based, trauma-informed services into primary
care settings. This three-year demonstration project aims to:
--Study how primary care settings can best screen and provide care to
children impacted by ACEs, including strengths, limitations,
and implementation challenges; and
--Produce a scalable model that can help pediatric providers
effectively integrate screening with strength-based, trauma-
informed care and services in primary care settings.
National Survey of Children's Health:
The National Survey of Children's Health (NSCH), funded and
directed by HRSA's Maternal and Child Health Bureau, is the nation's
largest annual survey of children's health at the state and national
levels.
This parent-reported survey includes questions to assess a range of
Adverse Childhood Experiences (ACEs) among U.S. children.
Data from 2019-2020, show that 21.7 percent of U.S. children ages
0-17 had experienced one ACE in their lifetime, while 18.1 percent had
experienced two or more ACEs. Data from the 2021 NSCH will be released
on October 3rd, 2022.
Question. Secretary Becerra, the United States is world's largest
importer of personal protective equipment. Three-quarters of N95 masks
in the U.S. are produced overseas, the majority from China. And from
2019 to 2020, American imports of PPE from China skyrocketed from $2
billion to $14 billion. This created shortages and price spikes--
resulting in those horrific images of our health heroes wearing garbage
bags to stay safe. 80 percent of nurses reported re-using masks meant
for single use. When it came to our prized Federal backstop--the
Strategic National Stockpile--the supply was inadequate. 5 million N95
masks in the Stockpile were expired. Governors only got a fraction of
the masks, gowns, and gloves they asked for.
Senator Cassidy and I have introduced the PPE in America Act to
boost domestic manufacturing of PPE and medical supplies so we no
longer have to rely on China and others to keep our health workers
safe. Our bill would use the purchasing power of the Stockpile as an
engine to sustain domestic PPE manufacturers. And it would enable a
replenishable, churning mechanism for the Stockpile to routinely sell
supplies to other agencies, states, and the commercial market . . . and
re-stock equipment from domestic producers. This arrangement will
provide predictability that domestic PPE manufacturers can depend on .
. . and will improve their coordination with the Stockpile to avoid
expiration of supplies.
Secretary Becerra, I'm pleased to see the budget proposes a $200
million increase for the Stockpile. Do you support policies that boost
domestic PPE production, mitigate risk for expiration, and provide
sustainability for manufacturers, including through replenishing
mechanisms for the SNS?
Answer. The global pandemic has highlighted the vulnerabilities of
the global supply chain. It is critical that steps are taken to invest
in expansion of U.S. domestic manufacturing capacity. To that end, the
Office of the Assistant Secretary for Preparedness and Response (ASPR)
is leveraging the authorities delegated to the Secretary under the
Defense Production Act (DPA) to ensure that private sector partners
making life-saving products are able to acquire raw materials, retool
their machinery, scale their production facilities, train their
workforces, and ultimately deliver their product. Throughout the COVID-
19 response, ASPR has used the DPA authority to issue 46 priority
ratings for United States Government (USG) contracts for health
resources, eight priority ratings for USG contracts for industrial
expansion, and 3 priority ratings for non-USG contracts to indirectly
support COVID-19 and/or mitigate the potential stockout of critical
lifesaving therapies. Going forward, ASPR will continue to build
capacity and partnerships with private industry toward the shared goal
of ending the COVID-19 pandemic and preparing for future pandemics.
ASPR is also working to support efforts in expanding the domestic
industrial base. These industrial base expansion (IBx) efforts seek to
reduce supply chain vulnerabilities and generate a domestic ``warm-
base'' for manufacturing that can be leveraged in a crisis. During the
COVID-19 pandemic, all contracts--competitive and sole-sourced--awarded
by the Department of Health and Human Services for N95 respirators were
for U.S.-produced supplies. A total of approximately 800 million
domestically produced N95 respirators were procured for the Strategic
National Stockpile. Contracting actions executed in March 2020 were
intended to encourage manufacturers to immediately increase production
of N95 respirators, and these manufacturers with domestic production
capabilities stepped up to support the nation with quality products at
the best prices for the USG. Furthermore, with $10 billion received for
emergency medical supplies enhancement, ASPR has been establishing and
maintaining domestic capacity for critical supplies.
Lastly, ASPR's Hospital Preparedness Program (HPP) included two
requirements in the fiscal year 2019-2023 funding opportunity
announcement to help address supply chain vulnerabilities. First, HPP
recipients and their healthcare coalitions must conduct a supply chain
integrity assessment to evaluate equipment and supplies that will be in
demand during emergencies and develop mitigation strategies to address
potential shortfalls. Second, each healthcare coalition must update and
maintain a regional resource inventory assessment.
ASPR will continue to assess and monitor domestic manufacturing
capabilities going forward. As the COVID-19 pandemic continues, we will
modify and refine efforts, as needed, to ensure they do not interfere
with the private sector but support efforts to maintain and build a
robust domestic capability.
Question. One of the major lessons learned from the pandemic was
the need to bolster our healthcare workforce. But this is not a new
problem. Even before COVID-19, our nation faced a shortfall of 120,000
doctors and a quarter-million nurses, with many rural and urban areas
facing recruitment challenges. Across Illinois, 5 million people live
in shortage areas for mental health providers, 3 million with too few
primary care doctors. The problem starts with medical education in
America. We take promising students, put them through years of rigorous
education and training, and license them on one condition: student loan
debt that can average more than $200,000. The burden of paying off
these loans steers our brightest minds into higher- paying specialties
and more affluent communities. This is especially true for healthcare
providers of color. You may be aware there are fewer Black men entering
medical school today than there were in the 1970s. Black and Latinx
Americans make up 31 percent of the nation's population, yet just 6
percent of doctors. We know that this discrepancy leads to worse care
and outcomes for patients of color.
Thankfully, the National Health Service Corps helps to address
these gaps by providing scholarship or loan repayment for healthcare
workers who commit to serve in urban and rural areas with shortages.
President Biden's American Rescue Plan included a provision I authored
with Senator Rubio to provide $1 billion in loan repayment and new
scholarship awards to the National Health Service and Nurse Corps. It
will help surge tens of thousands of new clinicians into under-served
areas, representing the largest single-year appropriation to our
healthcare pipeline in history. We know that scholarship-based awards
can make a particularly meaningful difference when it comes to
emphasizing recruitment from under-represented populations.
The pandemic has also magnified acute workforce shortages in
communities facing natural disasters or other public health
emergencies. The GAO has recently reported on how the National Disaster
Medical Service--which activates health personnel from private
practices for deployment intermittent Federal employees--does not have
the planning in place to ensure a workforce capable of responding to
nationwide or multiple concurrent health events, and that its workforce
is only a fraction of its target level. I have introduced legislation
with Senator Rubio (S.54, the Strengthening America's Health Care
Readiness Act), to test a pilot program that provides supplemental loan
repayment for NHSC alumni who continue to practice in a shortage area,
and current NHSC clinicians, who concurrently serve in the NDMS and are
available for rapid, short-term deployment for health emergencies.
Under this pilot program, HRSA and ASPR would have the authorities and
directive to coordinate to ensure adherence to their core missions and
the appropriate application of NHSC contract requirements and covered
benefits/protections of NDMS employment. I have also introduced
legislation with Senator Blackburn (S.924, Rural America Health Corps
Act), to increase recruitment and retention of NHSC clinicians in rural
areas, given the fact that only 5 percent of incoming medical students
hail from rural areas and one-third of placements are in rural
communities. This legislation would test a pilot program to explore
whether an elongated service commitment and increased loan repayment
award--5 years and $200,000--could enhance recruitment and retention in
rural America.
Secretary Becerra, your budget proposes a $47 million increase to
the National Health Service Corps. Do you support using appropriations
for certain pilot program approaches that test and evaluate new
strategies to address specific nuances and acute gaps in our country's
health workforce needs, including in health preparedness, health
disparities, and in rural America?
Answer. HRSA will implement the programs that Congress enacts. The
aim of National Health Service Corps (NHSC) is to address the primary
care needs of underserved populations and to provide them with access
to quality healthcare. The $47 million request for the NHSC will be
dedicated to bolstering the health workforce in rural and underserved
communities where there is an existing shortage of primary care
providers. Similar, in part, to the goals of the Rural America Health
Corps Act, the proposed funding will expand access to primary care
services to vulnerable populations, specifically those areas facing
barriers to obtaining evidence-based substance use disorder (SUD)
treatment services. The NHSC Rural Community Loan Repayment Program
(LRP), SUD Workforce LRP, and the traditional NHSC LRP will serve as
the mechanisms for distributing this requested funding, as these
programs have proven their effectiveness in mobilizing and retaining
providers in the areas where they are needed most. A total of 28,405
clinicians in the NHSC and Nurse Corps completed their service between
2012 and 2019; of these, 80 percent continue to serve in Health
Professional Shortage Areas (HPSAs) after their service obligation is
completed. One out of three of those NHSC alumni work in rural
communities. Over the same timeframe, 78 percent of the NHSC
participants who completed their service obligation at a site in a
rural area continue to work in a rural area, with over 50 percent
continuing to work in a HPSA in the same county where they completed
their NHSC service.
The Hospital Preparedness Program (HPP) supports efforts to
strengthen healthcare sector readiness to provide coordinated, life-
saving care in the face of emergencies and disasters. The HPP portfolio
supports a comprehensive, national network for healthcare preparedness
and response. The programs and activities within the HPP portfolio are
coordinated to address the many, complex facets of the nation's
healthcare system, creating mechanisms and infrastructure to improve
coordination between localities, states, and regions, as well as
developing new capabilities (e.g., telemedicine, specialty healthcare,
etc.) specific to key challenges within the modern threat landscape
(e.g., highly pathogenic disease; biological/chemical incidents, etc.).
As the primary source of Federal funding for healthcare system
preparedness and response, HPP promotes a consistent national focus to
improve patient outcomes during emergencies and to enable rapid
healthcare service resilience and recovery. Since 2002, investments
administered through HPP have improved individual healthcare entities'
preparedness and have built a system for coordinated healthcare system
readiness and response through healthcare coalitions (HCCs) and other
partnerships, such as the Regional Disaster Health Response System
(RDHRS) demonstration project. With respect to infrastructure needs,
recipients of funding are expected to consider how to provide and plan
for uninterrupted care when faced with damaged or disabled healthcare
infrastructure during an emergency response; however, the HPP
cooperative agreement does not allow for construction or major
renovation costs.
HPP provides cooperative agreement funding to states to support
healthcare system preparedness efforts. Specific to Colorado, if
appropriated at the requested level in fiscal year 2022, it is
estimated that Colorado will receive $3,584,461 via the HPP cooperative
agreement. Colorado will delegate this funding within the state to
support such efforts, including enhancing rural capabilities.
--Additional ASPR Programs and Tools Concerning Colorado and Rural
Health:
--The Denver Health and Hospital Authority was also recently
awarded the Partnership for Disaster Health Response System
Cooperative Agreement to establish the Region 8 Mountain
Plains RDHRS demonstration site. To address gaps in
regional healthcare delivery during disasters, ASPR
developed the RDHRS: a tiered system that builds upon and
unifies existing healthcare and ASPR assets within states
and across regions that supports a more coherent,
comprehensive, and capable healthcare disaster response
system able to respond to health security threats. The
RDHRS helps improve disaster readiness capabilities and
capacity, increase medical surge capacity, and extend
provision specialty care--including trauma, burn and
infectious disease, among others--during large-scale
disasters or public health emergencies.
--Additionally, the Rural Health Care Surge Readiness Portal was
established in 2020 to provide the most up-to-date and
critical resources for rural healthcare systems preparing
for and responding to a COVID-19 surge. The resources span
a wide range of healthcare settings (including EMS,
inpatient and hospital care, ambulatory care, and long-term
care) and cover a broad array of topics ranging from
behavioral health to healthcare operations to telehealth.
This portal was developed by the COVID-19 Healthcare
Resilience Working Group, a partnership with the U.S.
Department of Health & Human Services, the U.S. Department
of Homeland Security, and other Federal agencies, to
provide support and guidance for healthcare delivery and
workforce capacity and protection.
______
Questions Submitted by Senator Jack Reed
Question. My colleague on the LHHS Subcommittee, Sen. Capito, and I
authored the Childhood Cancer Survivorship, Treatment, Access, and
Research (STAR) Act--the most comprehensive childhood cancer bill in
history--which was signed into law on June 5, 2018 (Public Law No: 115-
180). Every year since becoming law, Congress has provided full funding
($30 million) to support the programs created by the STAR Act. However,
two provisions remain to be implemented: Title 2, Section 201(a), which
requires the Secretary of Health and Human Services to make awards to
establish pilot programs to develop, study, or evaluate model systems
for monitoring and caring for childhood cancer survivors throughout
their lifespan, including evaluation of models for transition to adult
care and care coordination; and Title 2, Section 201(b), which requires
the Secretary to conduct a review of HHS activities related to
workforce development for healthcare providers who treat pediatric
cancer patients and survivors and to report the findings within 2 years
of the enactment of the STAR Act.
Could you provide a status update on the implementation of these
two key provisions of the STAR Act?
Answer. Senator Reed, first, thank your sponsorship of the
Childhood, Cancer Survivorship, Treatment, and Research Act (STAR Act).
The STAR Act enhances the research on the late effects of childhood
cancers and is a critical step toward improving the quality of life for
survivors of childhood cancer. The Agency for Healthcare Research and
Quality (AHRQ) has partnered with the National Cancer Institute (NCI)
to commission three evidence reports as part of the Department's
response to the two provisions of the Act that you reference: Section
201(a) and 201(b).
--Disparities and Barriers to Pediatric Cancer Survivorship Care
(https://effectivehealthcare.ahrq.gov/products/pediatric-
cancer-survivorship/research). The report was posted on the
AHRQ for public comment in October 2020, with simultaneous peer
review and the final report was published March 1, 2021.
--Findings from the report were presented on April 20, 2021 on a
free NCI- sponsored webinar. The recording can be found at
https://cancercontrol.cancer.gov/ocs/events/disparities-
and-barriers.
--A manuscript titled ``Interventions to address disparities and
barriers to pediatric cancer survivorship care: a scoping
review'' derived from the report was published in the
Journal of Cancer Survivorship on June 16, 2021.
--Findings from the technical brief were presented at University of
Cincinnati Hematology-Oncology Grand Rounds (5/28/2021); MD
Anderson Cancer Survivorship Grand Rounds (6/18/2021);
Cancer Support Community Seminar (7/27/2021); and the
University of Kentucky Markey Cancer Center Affiliate
Network's 15th Annual Cancer Care Conference (9/30/2021).
The NCI used the findings of the report to provide administrative
supplements for the ``NCI P30 Cancer Center Support Grants'' to support
research to understand and address organizational factors that
contribute to disparities in outcomes among childhood cancer survivors.
Additionally, this report has already begun to inform the broader
cancer survivorship research community and survivorship care providers
based on dissemination of the review findings.
--Models of Care That Include Primary Care for Adult Survivors of
Childhood Cancer (https://effectivehealthcare.ahrq.gov/
products/pediatric-adolescent-cancer-survivorship/protocol).
This report was posted on the AHRQ website for four weeks of
public comment in June 2021, with simultaneous peer review. The
report is now being finalized. The final report is expected to
be shared with NCI and publicly posted by the end of 2021.
AHRQ and NCI expect to widely disseminate this report to the
research community and the general public once it can be
publicly posted to raise awareness of the role that primary
care providers can play in the care of adult survivors of
childhood cancer. The NCI also plans to use the findings of
this report to evaluate its current grant portfolio, to
identify and assess potential gaps and opportunities for
additional research on this topic.
Transitions of Care from Pediatric to Adult Services for Children
with Special Healthcare Needs (https://
effectivehealthcare.ahrq.gov/products/transitions-care-
pediatric-adult/protocol). The draft report was posted on
AHRQ's website in September 2021 for four weeks of public
comment and simultaneously underwent peer review. A final
report will be shared with NCI and posted publicly in 2022.
Similar to the Models of Care report, AHRQ and NCI expect to widely
disseminate this report to the research community and the
general public once it can be publicly posted to raise
awareness of challenges in transitioning care from pediatric to
adult services for children with special healthcare needs. This
report is expected to serve as a resource for those with
interests related to a number of serious healthcare diseases
and conditions including cancer. The NCI also plans to use the
findings of this report to evaluate its current grant
portfolio, to identify and assess potential gaps and
opportunities for additional research on this topic.
______
Questions Submitted by Senator Jeanne Shaheen
Question. While I am pleased that we've made so much progress on
vaccinations and getting through this pandemic, I continue to hear from
hospitals and nursing homes in New Hampshire that are running on tight
budgets after significant financial losses due to the pandemic. In
particular, many of these hospitals and nursing homes are located in
southern New Hampshire counties that were left behind in previous
rounds of the Provider Relief Fund. These providers did not qualify for
previous rural-focused rounds of the grants, despite treating
significant portions of patients from surrounding counties that are
rural. To help address that, we worked to give HHS more flexibility to
make these types of hospitals and nursing homes eligible for the $8.5
billion in Provider Relief Fund grants from the American Rescue Plan
Act of 2021.
Do you have an update that you can share on the plans that HHS has
for the remaining Provider Relief Fund grants that have not yet been
awarded?
Answer. HHS is committed to distributing the remaining provider
relief payments as quickly, transparently, and equitably as possible
while utilizing effective safeguards to protect taxpayer dollars. HHS
is planning for future Provider Relief Fund (PRF) allocations,
including the $8.5 billion from American Rescue Plan Act and Phase 4 of
the General Distribution.
HHS is actively considering feedback from stakeholders, as well as
operational lessons learned from prior PRF payments, as part of the
planning process. The feedback from Members of Congress and other
stakeholders informs HHS' ability to administer the PRF in a manner
that bolsters the healthcare system and helps providers experiencing
COVID-related financial hardships during this crisis. HHS will publish
additional information on future distributions on the Health Resources
and Services Administration's PRF webpage, at www.hrsa.gov/provider-
relief, as soon as it becomes available.
Question. I am pleased that the President has announced his
intention to resettle 62,500 refugees in the second half of this fiscal
year. However, the enormous cuts to refugee resettlement over the past
4 years under the previous Administration have severely decimated the
U.S. Refugee Admissions Program's capacity to provide local support for
newly arrived refugees. Local resettlement agencies face substantial
challenges as they work to restore their staffing and the services they
provide, and they need timely support in order to hire and train the
new staff necessary to meet the needs of increased numbers of newly-
arrived refuges.
What specific measures are you taking to help resettlement agencies
bolster capacity and prepare for the increased rate of refugee arrivals
in the second half of this fiscal year?
Answer. The President's fiscal year 2022 budget request includes an
increase of $515 million over the fiscal year 2021 enacted level for
Refugee and Entrant Assistance programs to accommodate the expected
increase in arrivals through the end of this calendar year and beyond.
This request would support a total of up to approximately 214,000
arrivals in fiscal year 2022, including up to 125,000 refugees as well
as other entrants, such as asylees, Cuban and Haitian entrants, and
Special Immigrant Visa holders.
This includes more than doubling the Refugee Support Services
program, from $207 million in fiscal year 2021 to $450 million in the
fiscal year 2022 Budget. This is one of the major sources of funding
for resettlement agencies to bolster their capacity.
In addition to the potential budgetary support, ORR has taken
several programmatic steps to ensure that the resettlement network is
prepared for an increase in refugee and other ORR-eligible arrivals.
ORR conducted listening sessions in the spring of 2021 to better
understand current state and local capacity to resettle refugees, plans
to increase resettlement capacity, and barriers to such growth. ORR and
the Department of State/PRM conducted a joint training for State
Refugee Coordinators to ensure understanding of their role in local
capacity planning.
ORR and PRM are exploring options to strengthen policy and practice
for the required community consultations, as well as private
sponsorship. ORR staff are conducting coordinated outreach with other
Federal agencies to ensure access to mainstream benefits and services.
We are also planning for enhancements to existing services such as
mental health, employer engagement, youth and family literacy,
Preferred Communities and Matching Grant in anticipation of increased
arrivals.
Question. Does ORR anticipate being able to provide forward funding
to refugee resettlement agencies, so they have the advance funding
necessary to build capacity in anticipation of the increased rate of
refugee arrivals?
Answer. ORR continues to provide support and guidance to its
partners and anticipates being able to provide sufficient forward
funding through the President's fiscal year 2022 budget request.
______
Questions Submitted by Senator Brian Schatz
Question. In the hearing, you agreed that Congress should move
forward with legislation to expand telehealth coverage in Medicare and
committed that you would work with Congress to provide the necessary
data and technical assistance to enact telehealth legislation this
year. You also stated that you need ``greater accountability'' and
``better authority.''
What authority to ensure accountability and put safeguards into
place for telehealth services does HHS need that it does not already
have?
What measures to ensure accountability does HHS plan to put into
place when Congress expands coverage of telehealth services?
What has the HHS Office of Inspector General determined about
concerns related to fraud, waste, and abuse associated with expanded
utilization of telehealth during the COVID-19 pandemic?
Last July, ASPE released early data on Medicare beneficiary use of
telehealth. Is HHS planning to release additional data on the use of
telehealth in Medicare during the pandemic?
What is the expected timeframe on the study that CMS has
commissioned on the telehealth flexibilities during the COVID-19
pandemic?
What Center for Medicare and Medicaid Innovation (CMMI) models
include telehealth waivers, and what are those waivers for? For each
waiver, please specify how many model participants have elected the
waiver and how many beneficiaries have used telehealth services under
the waiver.
In which CMMI models have waivers enabled healthcare professionals
other than physicians and practitioners to furnish telehealth services,
and how many participants have used those waivers?
A 2018 OIG report recommended that CMS offer education and training
sessions to practitioners on Medicare telehealth requirements. How has
CMS addressed this recommendation?
Answer. Telehealth is an important tool to improve health equity
and improve access to healthcare. Healthcare should be accessible, no
matter where you live. HHS continues to examine the telehealth
flexibilities developed for the current public health emergency and
determine how we can build on this work to improve health equity and
improve access to healthcare. An HHS study released by ASPE has shown
that massive increases in the use of telehealth helped maintain some
healthcare access for Medicare beneficiaries during the pandemic. CMS
also released a data snapshot showing increases in Medicare
telemedicine utilization during the pandemic. Lessons learned from CMS
Innovation Center models also provide valuable insight into how
providers furnish high-value care and innovate in care delivery,
including the use of telehealth. In addition to looking at which
flexibilities HHS can and should continue administratively, I look
forward to working with Congress to address changes that may need to be
done through legislation.
HHS is also dedicated to making sure providers are aware of the
telehealth options available to them as they treat their patients. CMS
routinely educates practitioners through various channels, including
the Medicare Learning Network, weekly electronic newsletters, and
quarterly compliance newsletters. CMS will continue to use channels
such as these to educate and provide training sessions for
practitioners on Medicare telehealth requirements and related
resources.
ASPE/HHS is currently preparing a follow-up issue brief on Medicare
FFS beneficiary use of telehealth compared with in-person visit trends
in 2020 which will examine telehealth use by beneficiary
characteristics including race/ethnicity, urban/rural geography, state,
visit type (primary care, specialist, mental health. The brief will
also examine various telehealth modalities, including audio-only
visits, telecommunications in addition to two-way interactive video-
based telehealth visits and whether the beneficiary was located at home
or in a health-care setting for the telehealth visit. This issue brief
is anticipated to be published later this fall.
OIG is conducting significant oversight work (8 ongoing audits and
studies) assessing telehealth services during the public health
emergency. Once complete, these reviews will provide objective,
independent findings and recommendations to policymakers and other
stakeholders regarding the effect that the public health emergency
flexibilities had on telehealth. This work will help HHS ensure the
potential benefits of telehealth are realized for patients, providers,
and HHS programs without being compromised my fraud, abuse, or misuse.
OIG anticipates the first telehealth work products to be published this
fall.
Question. The Bipartisan Budget Act of 2018 authorized Medicare
Advantage plans to offer additional telehealth benefits in their annual
bid amount beyond eligible telehealth services under Medicare fee-for-
service.
What percentage of plans have offered additional telehealth
benefits?
What type of additional telehealth benefits have been offered
(i.e., types of services, types of healthcare professionals, etc.)?
Has HHS determined if there are any concerns related to fraud,
waste, and abuse associated with additional telehealth benefits in
Medicare Advantage plans?
Answer. Beginning in plan year 2020, Medicare Advantage plans have
been permitted, but not required, to offer additional telehealth
benefits as part of the basic benefit package beyond what is allowable
under the original Medicare telehealth benefit. These benefits can be
available in a variety of places, and people with Medicare Advantage
plans can use them at home instead of going to a healthcare facility.
For plan year 2021, over 94 percent of Medicare Advantage plans offered
additional telehealth benefits reaching 20.7 million beneficiaries.
Medicare Advantage plans have the flexibility to determine which
services are clinically appropriate to furnish through additional
telehealth benefits on an annual basis, consistent with the limits in
statute and regulations. For example, a Medicare Advantage plan may
offer a dermatology exam using store-and-forward technology.
All Medicare Advantage plans are required to have an effective
program to prevent, detect, and correct Medicare Advantage
noncompliance and fraud, waste, and abuse. HHS is committed to
oversight of plan compliance with this requirement while ensuring
access to care for Medicare Advantage enrollees through additional
telehealth benefits.
Question. In January, HHS said that the COVID-19 public health
emergency declaration would likely be in place for all of 2021.
As we are now halfway through 2021, does HHS have an updated
expectation for how long the public health emergency will last?
What are the factors you are considering for when the public health
emergency could be declared over (i.e., vaccination rates, daily cases,
etc.)?
Answer. The Secretary of Health and Human Services may, under
section 319 of the Public Health Service (PHS) Act, determine that: (a)
a disease or disorder presents a public health emergency (PHE); or (b)
that a public health emergency, including significant outbreaks of
infectious disease or bioterrorist attacks, otherwise exists. If and
when declared, a PHE lasts until the Secretary declares that the
emergency no longer exists or for 90 days, whichever comes first, but
it may be extended for additional 90-day periods as needed and as
determined by the Secretary.
HHS will continue to evaluate the infection rate of COVID-19 and
will modify the PHE, as needed, when cases decrease and the authorities
under a PHE are no longer needed to support response operations.
Question. In the hearing, you agreed that it would be helpful for
Federal response agencies, such as CDC, FDA, and NIH to be able to
respond proactively to public health emergencies before they get out of
control.
Would automatic funding to the Public Health Emergency Fund upon
the declaration of certain public health emergencies--including
infectious disease outbreaks--modeled after FEMA's Disaster Relief
Fund, be helpful to ensure a quick and effective response to public
health emergencies?
Answer. A key lesson learned during the ongoing COVID-19 pandemic
is that having available funding in the Public Health Emergency Fund
would ensure that HHS can immediately respond while working in
partnership with Congress on broader supplemental needs. For example,
during the initial days of the COVID-19 pandemic, the Biomedical
Advanced Research and Development Authority (BARDA) shifted program
funds and redirected contracts from some of its investments in emerging
infectious diseases (Zika and Ebola contracts) and leveraged pandemic
influenza preparedness contracts to support vaccine and therapeutic
development efforts. The funds were used to start a few critical
programs early on; however, there were insufficient funds available to
start the multi-pronged approach that led to success in both the
vaccine and therapeutic development efforts. Using funds planned for
other programs impacted the long-term investments that were in place
for other identified threats, and there is no guarantee in a future
public health emergency, that it would be possible to similarly shift
program funds.
If funded, the Public Health Emergency Fund would ensure that HHS
could take immediate action to respond to a public health emergency
before Congress enacts supplemental funding legislation. Immediate
action can reduce the overall societal and economic impact of the
public health emergency, reduce the lead time for development of
supporting resources (e.g., medical countermeasure development if
needed), and ultimately result in less overall expenditures if
potential threats are quickly contained.
Question. The pandemic has illustrated that Native communities
often do not have access to the same resources that other communities
do. For example, IHS-funded Tribal epidemiology centers are public
health authorities, but do not have access to CDC public health
authority data. And HHS agencies do not often work with states and
other public health authorities to improve data collection to allow for
disaggregation of American Indian/Alaska Native/Native Hawaiian
information.
How will you ensure that Native health systems, especially Native
public health systems, have parity access to HHS resources going
forward?
What steps is HHS taking to include Native Hawaiians, who are too
often overlooked and left out, in HHS programs and initiatives?
Answer. Regarding your question about Native health systems, the
HRSA funding opportunities for which tribes and tribal organizations
were eligible to compete, as well as awards to tribes and tribal
organizations have expanded.
HRSA's Office of Intergovernmental and External Affairs leads the
agency's Tribal Affairs, participates in HHS Tribal Consultations, and
collaborates with IHS and other Federal and community stakeholders to
address tribal issues. In response to tribal requests, the HRSA Tribal
Advisory Council is being established to provide advice on how HRSA
programs can better address tribal needs. HRSA IEA regional offices
regularly communicate with tribal leaders to respond to issues and
ensure they are aware of HRSA funding opportunities, program updates,
and technical assistance.
In fiscal year 2020, tribes and tribal organizations were awarded
more than $16 million from Rural Tribal COVID-19 Response Program. The
awards were distributed to 57 recipients across 22 states.
Additionally, in fiscal year 2020, the Health Center Program
awarded grant funding as further described below for Tribal/Urban
Indian health center organizations.
--Awarded nearly $88 million in annual operational grant funding to
35 health center organizations operating over 250 service
delivery sites serving Native communities across the U.S.
--Awarded over $2.3 million to Tribal/Urban Indian health centers to
support infrastructure needs related to disaster response and
recovery efforts.
--Awarded $31 million in Health Center Program supplemental funding
to Tribal/Urban Indian health centers to support efforts to
address the impact of the COVID-19 pandemic.
Below are fiscal year 2021 Health Center Program actions related to
health centers that are tribes or tribal organizations providing health
services within Native American communities:
--Continued annual health center operating grants, totaling
approximately $88 million for 35 health center organizations.
--Awarded $60 million to 35 Tribal/Urban Indian health centers, as
part of the American Rescue Plan Act awards. Health centers use
the funds to support and expand COVID-19 vaccination, testing,
and treatment for vulnerable populations; deliver needed
preventive and primary healthcare services to those at higher
risk for COVID-19; and expand health centers' operational
capacity during the pandemic and beyond, including modifying
and improving physical infrastructure and adding mobile units.
This investment will help increase access to vaccinations among
hard- hit populations, and increase confidence in the vaccine
by empowering local, trusted health professionals in their
efforts to expand vaccinations.
--In fiscal year 2021, HRSA and the Centers for Disease Control and
Prevention launched the Health Center COVID-19 Vaccine Program
to allocate COVID-19 vaccines to HRSA-supported health centers
directly. The program ensures our nation's underserved
communities and those disproportionately affected by COVID-19
are equitably vaccinated against COVID-19. HRSA invited all
HRSA funded health centers to participate in the program,
including the 35 Tribal/Urban Indian health centers. Eight
tribal organizations have set up accounts to participate in the
Health Center COVID-19 Vaccine Program. Six of the eight tribal
organizations have placed at least one order through the
program.
--In late September 2021, HRSA expects to announce approximately $1
billion in awards supporting health center construction,
expansion, alteration, renovation, and other capital
improvements to modify, enhance, and expand healthcare
infrastructure.
HRSA projects that 32 grants totaling approximately $18 million
will be awarded to Tribal/Urban Indian health centers through this
funding opportunity.
native hawaiian health care systems
In fiscal year 2021, HRSA provided $20.5 million in grants and
scholarship awards to Native Hawaiian Health Care Systems to improve
the provision of comprehensive disease prevention, health promotion,
and primary care services to Native Hawaiians.
Additionally, in fiscal year 2021, HRSA provided $20 million under
the American Rescue Plan Act to Native Hawaiian Health Care Systems to
aid their response to COVID-19. The awards provided six Native Hawaiian
Health Care Improvement Act (NHHCIA) recipients resources to strengthen
vaccination efforts, respond to and mitigate the spread of COVID-19,
and enhance healthcare services and infrastructure in their
communities.
technical assistance--health centers located in hawaii
HRSA continues to make technical assistance available for Hawaii
health centers to identify and address the primary healthcare needs of
their target communities and populations, and to aid in identifying
Federal programs to support those efforts. HRSA IEA Region 9 Office can
assist Hawaii stakeholders with technical assistance and other HRSA
resources.
______
Questions Submitted by Senator Joe Manchin, III
Question. Secretary Becerra, as you may be aware, Federal data
shows that more than 1.5 million students experienced homelessness in
the 2017-2018 school year, and in my home state of West Virginia, we
had well over 10,000 students identified as homeless during the 2019-
2020 school year alone. Unfortunately, identification and reporting
challenges have existed for years, and when you couple those existing
challenges with the COVID-19 pandemic- we can only expect these numbers
will be far greater than pre-pandemic levels. The Administration of
Children and Families (ACF) is tasked with promoting the economic and
social well-being of families and children, including those
experiencing homelessness. That is why, in the height of the pandemic,
I worked alongside Senator Murkowski and others to introduce the
Emergency Family Stabilization Act; that would have created a dedicated
funding stream through ACF to assist children, youth, and families
experiencing homelessness during the COVID-19 pandemic. While I was
able to work with my colleagues to secure dedicated funding through the
Department of Education for identifying and assisting children and
youth experiencing homelessness, it is not a permanent solution and
does not incorporate the all the needed resources to address the issue.
In recognizing the pandemic has greatly increased the need for
better access to services for children, youth, and families
experiencing homelessness; how does the President's budget further
improve resources for those charged with identifying and connecting our
children and youth experiencing homelessness with the services provided
by ACF?
Answer. The Administration for Children and Families receives
funding, through the Runaway and Homeless Youth Act (RHYA), to provide
services and resources to youth experiencing homelessness. Through the
Family and Youth Services Bureau (FYSB), ACF funds a National
Communications System (NCS), which is a national, toll-free, runaway
and homeless youth crisis hotline to assist runaway and homeless youth,
and those at risk of running away, in communicating with their families
and with service providers. The NCS includes telephone, Internet,
mobile applications, and any technology-driven services used for
runaway and homeless youth or youth who are at risk of running away.
The NCS provides crisis intervention, referral services, information,
and prevention resources to youth at risk of separation from their
families, runaway and homeless youth, their families, legal guardians,
and service providers.
The RHYA also authorizes the Runaway and Homeless Youth Training &
Technical Assistance Center (RHYTTAC) to provide training and technical
assistance to RHY program-funded grantees and allied professionals.
RHYTTAC assists these organizations in developing effective approaches
for serving runaway and homeless youth, accessing new resources to
enhance their ability to serve these youth, and establishing linkages
with other programs with similar interests and concerns. RHYTTAC also
helps to ensure that grantees have effective interventions in place to
build skills and capacities that contribute to the healthy, positive,
and productive functioning of children and their successful transition
from youth into adulthood.
The President's fiscal year 2022 Budget proposed to fund RHY
programs at a level of $144,987,000, which would be an increase of
$8.2M from the fiscal year 2021 appropriation level. With the proposed
increase, ACF/FYSB will seek to increase the number of RHY grantees and
continue to support training and technical assistance. ACF commits to
working with other Federal youth-serving agencies to increase awareness
of resources available through RHY Programs, and to further develop
coordinated efforts to support prevention, outreach, engagement, and
timely referral to ACF services as well as services available from
other Federal agencies. Additionally, Head Start and Child Care
Development Fund (CCDF) Block Grants also serve families with young
children experiencing homelessness.
Question. During the COVID-19 pandemic, rural health providers have
been hit hard. Last year alone, West Virginia had three hospitals
close, putting patients at risk of accessing care. In response Congress
passed $8.5 billion in the American Rescue Plan aimed at supporting
rural health providers. Since this was signed into law, HHS has made no
announcements on the plan to distribute this funding, yet rural health
providers remain at risk.
When will this funding begin to be allocated to our rural
communities?
Answer. HHS is working to finalize the $8.5 billion in American
Rescue Plan Act of 2021 funding for rural Medicare and Medicaid
providers and suppliers. HHS is considering operational lessons learned
from prior Provider Relief Fund (PRF) payments, as well as feedback
from Members of Congress and other stakeholders.
Question. During the previous Administration, determining the
status of the Provider Relief Fund was nearly impossible to do. Will
you commit to ensuring transparency when distributing this $8.5 billion
for rural providers?
Answer. HHS is committed to an equitable, transparent, and
responsive approach when distributing future provider relief payments.
HHS has listened to stakeholder input and feedback and is committed to
ensuring equity in future PRF distributions, better support to
providers applying for funds, and transparency in communication to
providers. Furthermore, the Administration is committed to building a
strong working relationship with Congress going forward and plans to
provide periodic updates on the distribution of $8.5 billion for rural
providers.
Question. The COVID-19 pandemic had significant impacts on rural
communities in West Virginia, who were already at a disadvantage when
it comes to accessing healthcare services. We have seen exponential
growth in telehealth adoption across Americans of all ages, locations,
and conditions to help address these disparities. Telehealth is a
lifeline to countless patients and their doctors in my state of West
Virginia. Telehealth among Medicare beneficiaries has been made
possible by temporary flexibilities in place for the duration of the
public health emergency. You have previously committed to work to
expand certain telehealth policies after the end of the public health
emergency. And we have learned and seen in practice that telehealth has
saved lives throughout this pandemic.
Secretary Becerra, how do we ensure that there is equitable access
to telehealth services, particularly for individuals who lack a
connection to broadband and rely on audio-only methods to communicate
with their doctors?
Answer. Telehealth is an important tool to improve health equity
and improve access to healthcare. Healthcare should be accessible, no
matter where you live. HHS continues to examine the telehealth
flexibilities developed for the current public health emergency and
determine how we can build on this work to improve health equity and
improve access to healthcare.
There are a number of efforts underway to help underserved
communities and individuals, particularly rural and tribal communities,
utilize telehealth services through access to broadband Internet
connections. HRSA's Office for the Advancement of Telehealth serves as
HHS's focal point on telehealth, which includes the management of the
Telehealth.HHS.gov website and improving collaboration across HHS and
Federal agencies. For example, HRSA's Office for the Advancement of
Telehealth leads a Rural Telehealth Initiative, established through a
memorandum of understanding with HHS, the Federal Communications
Commission, and the
U.S. Department of Agriculture, to increase access to affordable
broadband services, which is the foundation for improving access to
telehealth services. HRSA's Office for the Advancement of Telehealth
also supports grants such as a Telehealth Broadband Pilot Program to
measure access to high speed Internet in rural and underserved
communities as well as programs to support the provision of direct
telehealth services, telementoring, research, licensure portability,
and technical assistance to providers and patients through the
Telehealth Resource Center Programs.
Question. What steps is the Department of Health and Human Services
taking to ensure that Americans who have come to rely on telehealth
services don't lose access when the public health emergency ends?
Answer. Telehealth services are an important tool to improve health
equity and access to healthcare. Throughout the pandemic, telehealth
services have filled an urgent need to maintain access to care while
social distancing was necessary. For example, federally Qualified
Health Centers and Rural Health Clinics were able to be paid by
Medicare as distant site telehealth service providers, which had not
been permitted outside of the COVID-19 public health emergency. After
the pandemic, HHS will continue to support telehealth services. HHS is
currently reviewing the telehealth flexibilities developed for the
current public health emergency to determine which can and should
continue after the public health emergency has ended. HHS plans to
continue to support telehealth after the pandemic through resources
like the Telehealth.HHS.gov website and the Telehealth Resource Centers
so patients and providers have access to telehealth technical
assistance.
Question. The 340B program is essential for providing access to
safe and affordable medications for low-income West Virginians.
Recently HHS determined that six pharmaceutical companies have violated
the program, by restricting access to contract pharmacies. The
undermining of the 340B program by pharmaceutical companies and
pharmacy benefit managers has taken its toll on West Virginia's
hospitals, community health centers and their contract pharmacy
partners.
What are the next steps HHS will be doing to ensure the integrity
of the 340B program?
Answer. On May 17, 2021, HRSA sent letters to six pharmaceutical
manufacturers stating that HRSA has determined that their policies
placing restrictions on 340B Program pricing to covered entities that
dispense medications through pharmacies under contract have resulted in
overcharges and are in direct violation of the 340B statute. In
addition, the letters explain that the 340B Program Ceiling Price and
Civil Monetary Penalties final rule (CMP final rule) states that any
manufacturer participating in the 340B Program that knowingly and
intentionally charges a covered entity more than the ceiling price for
a covered outpatient drug may be subject to a Civil Monetary Penalty
(CMP) not to exceed $5,000 for each instance of overcharging. Any
assessed CMPs would be in addition to repayment for each instance of
overcharging.
In its letters, HRSA informed the pharmaceutical manufacturers that
continued failure to provide the 340B price to covered entities
utilizing contract pharmacies, and the resultant charges to covered
entities of more than the 340B ceiling price, may result in CMPs as
described in the CMP final rule. While there is ongoing litigation on
these matters, HRSA is actively reviewing each manufacturer's response
to its May 17, 2021, letter to determine whether subsequent action,
such as referral to the HHS Office of the Inspector General for the
imposition of CMPs is warranted.
______
Questions Submitted by Senator Roy Blunt
covid-19 boosters
Question. Mr. Secretary, at our last two hearings--one with the CDC
Director and one with the NIH Director--the issue of whether we need
vaccine boosters was raised. Even from our own officials, there seems
to be a divide as to whether they'll be necessary. In early May, BARDA
notified the Subcommittee that they intend to purchase 400 million
vaccine doses for boosters for $7.9 billion. Does that notification
mean that you believe boosters are necessary? Even though neither the
Directors of CDC or NIH have officially said the same? My concern is
that it could be very dangerous if vaccine companies, rather than
public health experts, are stetting the public's expectations around
COVD-19 boosters.
Answer. Throughout the COVID-19 pandemic, BARDA has worked to
develop and ensure that once authorized and/or approved by the FDA
medical countermeasures (including vaccines) would be available to the
American public immediately or with minimal delay. This has meant,
contracting with companies to purchase millions of doses of vaccines
prior to FDA authorization based on the lead time for vaccine
manufacturing to ensure doses are available. Further, many
manufacturers require orders to be placed several months ahead of the
expected delivery date. Placing the order after a need is identified
would result in a lapse/gap in production and ultimate delivery.
Supporting the early manufacturing of countermeasures ensures that
once the FDA issues an EUA, vaccine doses are immediately available. It
has also meant that, if a vaccine we invested in failed, the USG would
have realized the financial risk associated with the aggressive
development strategy underlying Operation Warp Speed which is now
called the Countermeasures Acceleration Group or CAG. BARDA is taking
the same approach to purchasing additional vaccine doses to be
available immediately if/when the FDA authorizes/approves boosters.
covid-19 vaccines donated internationally
Question. Secretary Becerra, on June 3, 2021, the Administration
announced it would donate 80 million vaccines to the international
community by the end of June. Did the Department of Health and Human
Services fund the vaccines that are being donated?
Specifically, which vaccines are being donated? Please provide
estimates based on vaccine producer and number of doses.
Answer. All vaccine doses the Department of Health and Human
Services has purchased to date were ordered for domestic use. However,
international donations have been made available from amounts that have
been in excess of demand once vaccines were available for use.
barda misused funds
Question. In January, the Office of Special Counsel investigated
the misuse of funds appropriated to BARDA. The Special Counsel found
that at least since fiscal year 2010, the Office of Assistant Secretary
for Preparedness and Response misused funds appropriated for BARDA and
failed to accurately report this mismanagement to Congress. In fact,
the practice of using BARDA funding by ASPR for non-BARDA purposes was
so common that it was referred to in the agency as the ``Bank of
BARDA.'' Mr. Secretary, has the Department determined whether these
actions violated the Anti-deficiency Act and what steps has HHS taken
to address this issue?
Answer. HHS/ASPR is committed to ensuring taxpayers dollars are
used in the most judicious manner and in accordance with statutory
obligations. In response to the HHS Inspector General's report, HHS's
Office of Finance is undertaking an internal review of the HHS
Assistant
Secretary for Preparedness and Response (ASPR)'s use of advanced
research and development funding from the Public Health and Social
Services Emergency Fund for fiscal years 2015 through 2019 to identify
any potential Anti-deficiency Act violations. HHS also hired an outside
accounting firm which is auditing ASPR's use of these funds. Both
reviews are estimated to be completed in 2021.
disease x
Question. The COVID-19 pandemic has highlighted the need for the
Federal government to respond rapidly to the next fast-moving, novel
infectious disease. The fiscal year 2021 LHHS bill included language
that encouraged the Department of Health and Human Services to work
with the Department of Defense to implement a program focused on
developing flexible vaccines and antiviral treatments to address
emerging and previously unidentified infectious disease threats,
referred to as Disease X. Mr. Secretary, what progress has the
Department made in implementing such a program and how is the
Department planning to develop countermeasures for previously
unidentified viral threats?
Answer. While no specific Disease X program has been established,
BARDA does have processes and capabilities to prepare to respond to
various disease threats. While BARDA has a mandate to develop medical
countermeasures against emerging infectious disease threats, these
efforts cross over and could support a robust and effective response to
any rapidly emerging infectious disease event, subsequent to funding
availability. One example is BARDA's support of platform technologies
to develop vaccines and therapeutics for Ebola Zaire virus (Merck,
Janssen, Regeneron) and Zika (Moderna). When COVID-19 outbreaks began,
BARDA was able to pivot these efforts to develop medical
countermeasures to aid the response to the emerging threat.
unaccompanied children
Question. Mr. Secretary, while your Department has no role in
setting border policy or enforcing border security, HHS is responsible,
by law, for the safety and well-being of the unaccompanied children
referred to its care. And this fiscal year, HHS is on track to have the
highest number of referrals of unaccompanied children on record, with
almost 69,000 referrals already. Instead of working to open multiple
Influx facilities that provide an equivalent standard of care for
children as the shelters in the permanent network, HHS created a new
concept of Emergency Intake Sites that do not have the same
accountability requirements as Influx facilities and provide children
with only a minimal level of care. Why, months after this crisis began,
have you not opened additional Influx facilities or transitioned some
of these Emergency Intake Sites into Influx facilities?
Answer. ORR's preference is to place unaccompanied children into
state-licensed care provider facilities, including transitional foster
homes while their sponsorship suitability determinations or immigration
cases are adjudicated (in cases when a child has no viable sponsor).
ORR has prioritized increasing its network of state licensed beds by:
(1) safely bringing back online beds that were impacted by COVID-19
restrictions, (2) partnering with current providers to provide
additional bed capacity through recipient-initiated supplements, and
(3) engaging non-governmental organizations and governmental
jurisdictions to identify ways to expand bed capacity. However, during
a time of sustained high referrals, ORR activates and operates Influx
Care Facilities and Emergency Intakes Facilities (EIS) to meet its
statutory obligations to care for unaccompanied children (UC)
transferred from the Department of Homeland Security (DHS) and ensure
that children are not waiting in CBP custody for longer than 72 hours.
Since March 2021, ORR has activated a total of 14 EISs, and to date,
ORR operates only one ICF and three EIS. At a minimum, these EISs
provide lifesaving services, consistent with best practices in
humanitarian and disaster response efforts. In addition, ORR has been
working diligently to ramp up services including wrap-around services,
where possible, to ensure the safety and well-being of the children in
ORR care and custody.
Question. When do you expect to ensure that every unaccompanied
child in the care of HHS receives the required standard of care?
Answer. ORR recognizes that children who enter ORR care may have
experienced significant trauma not only in their home countries but
also during their journey to the United States, and ensures that ORR's
continuum of care remains rooted in trauma-informed care, and
prioritizes the best interest of each child across its network of care
provider facilities, including Carrizo ICF and the EISs.
Question. HHS has transferred or reprogramed almost $3 billion to
cover the costs of the influx of unaccompanied children crossing at the
southern border. Do you expect that the transferred amount will cover
the costs of the UC program for the remainder of the fiscal year?
Answer. Yes. HHS anticipates that the allocated amount will cover
the costs of the UC program through the end of the fiscal year.
Question. Do you anticipate that your request of $3.3 billion for
the program in fiscal year 2022 accurately reflects the amount needed
for the next fiscal year?
Answer. HHS strongly supports the President's budget request.
However, given the ever- evolving situation at the southern border, it
can be challenging to predict medium-to-long term funding needs with
any degree of certainty. HHS continues to gather data and employ
rigorous evaluation methods to inform its budgetary requests and
decisionmaking, and will continue to update the Office of Management
and Budget (OMB) and both the House and Senate Appropriations
Committees on the dynamic situation at the southern border and the
resultant resource requirements. HHS remains committed to working with
Congress to ensure all relevant funding needs are communicated in a
timely manner.
Question. What are the key assumptions behind both of those cost
estimates?
Answer. To arrive at its cost estimates, ORR considers a variety of
factors such as external political events, natural disasters, and other
issues that may impact the number of referrals from DHS.
Additionally, cost estimates for fiscal year 2022 includes
expanding the scope of post-release services and the number of children
who receive them, as well as other critical programmatic reforms such
as improving case management and implementing policies and procedures
intended to reduce the time it takes to unify children with their
sponsors.
organ transplantation
Question. Mr. Secretary, I was pleased to see the Administration
move forward with finalizing the Centers for Medicare and Medicaid
Services' (CMS) rule to improve oversight and accountability of organ
procurement organizations (OPOs) (CMS-3380-F2).
Related, a government contractor, the United Network for Organ
Sharing (UNOS), has great influence over the protocols and processes
for organ procurement and allocation. UNOS has held the government
contract to run the Organ Procurement and Transplantation Network
(OPTN) for roughly 35 years and appears to operate with little to no
oversight by HHS. Over the course of the last few years, UNOS policies
have had the effect of redistributing donated organs from the Midwest
and South to more urban and coastal areas. In addition to the CMS OPO
accountability rule, what more can the Department do to bring
accountability and oversight to the organ procurement process and to
hold the OPTN contractor accountable to actually improve the organ
transplantation system in the U.S.?
Answer. HRSA provides oversight of the OPTN and the OPTN
contractor. HRSA exercises its oversight according to statutory
requirements, regulatory requirements, and through the OPTN contract.
The OPTN Board of Directors develops organ allocation policies with the
advice of the OPTN membership and other interested parties The OPTN
contractor neither develops nor approves OPTN policies. HRSA staff are
ex-officio members of OPTN committees and the OPTN Board of Directors
and attend all OPTN business meetings.
HRSA currently works closely with CMS on CMS' regulation of organ
procurement and transplantation services. Additionally, HRSA and CMS
collaborated to establish a new Affinity Group on Organ Procurement and
Transplantation to improve oversight by the two agencies.
Question. The fiscal year 2021 Appropriations Joint Explanatory
Statement encouraged CMS to consider removing the disincentive for
Medicare Certified Transplant Centers to transfer patients suffering
from complete loss of brain function to organ recovery centers operated
by organ procurement organizations. What is the status of this work at
CMS?
Answer. CMS published a final rule \1\ on December 2, 2020 that
updates the OPO Conditions for Coverage to change the way OPOs are held
accountable for their performance. The final rule improves the current
measures by using objective and reliable data, incentivizes OPOs to
ensure all viable organs are transplanted, and holds OPOs to greater
oversight while driving higher OPO performance. Under new outcome
measures introduced in this final rule, except for pancreas procured
for research (which is required by law to be counted), an OPO will not
receive credit for procuring an organ if the organ is not transplanted,
creating greater incentive for OPOs to place all organs for transplant
that they procure. Following review, the final rule went into effect
March 30, 2021 (except for amendment 3).\2\
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\1\ https://www.Federalregister.gov/documents/2020/12/02/2020-
26329/medicare-and-medicaid-programs-organ-procurement-organizations-
conditions-for-coverage-revisions-to.
\2\ The January 20, 2021 memorandum from the Assistant to the
President and Chief of Staff, entitled ``Regulatory Freeze Pending
Review,'' instructed Federal agencies to delay the effective date of
rules published in the Federal Register, but which have not yet taken
effect, for a period of 60 days. The effective date of the final rule,
except for amendment number 3, which would have been February 1, 2021,
became March 30, 2021. CMS also included a 30-day public comment period
on the rule to allow interested parties to provide comments about
issues of fact, law and policy raised by the rule. The 60-day delay in
effective date was necessary to give Department officials the
opportunity for further review of the issues of fact, law, and policy
raised by this rule.
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mental health
Question. The pandemic has exacerbated the children's mental health
crisis across the country and we are seeing alarming increases in
children presenting in emergency rooms in severe crisis. Could you
comment on how your budget addresses this crisis and ensures that
children can get access to mental and behavioral health services
earlier, closer to home, and in their communities?
What are your thoughts on further efforts we should consider to
direct funding to address this crisis, such as Children's Hospital
Graduate Medical Education which helps train frontline professionals
focused on treating children's mental and behavioral health?
Answer. HHS is committed to improving access to mental and
behavioral healthcare services for children and families. The fiscal
year 2022 President's Budget requests includes an additional $756
million for SAMHSA to increase access to children's behavioral health
services, which includes $473 million for mental health, $281 million
for substance use treatment, and $2 million for substance use
prevention related services and activities.
Within HRSA, the Budget provides $10 million for pediatric mental
healthcare access to increase access to behavioral health. This
investment promotes behavioral health integration in pediatric primary
care by supporting the development of new, or the improvement of
existing, statewide or regional pediatric mental healthcare telehealth
access programs.
The Children's Hospitals Graduate Medical Education (CHGME) Program
is a formula based payment program that helps eligible hospitals
maintain Graduate Medical Education (GME) programs to support graduate
training for physicians to provide quality care to children. As such,
the program supports the training of pediatric psychiatrists and other
pediatric physician behavioral subspecialists. In Academic Year 2019-
2020, 199 Child and Adolescent Psychiatry fellows received training
through the CHGME Program. In addition, CHGME-funded hospitals served
as sponsoring institutions for 42 residency programs and 252 fellowship
programs, and also served as major participating rotation sites for 628
additional residency and fellowship programs. The CHGME Program also
supported the training of 5,433 Pediatric residents that included
General Pediatrics residents, as well as residents from seven types of
combined pediatrics programs (e.g., Internal Medicine/Pediatrics). In
total, 3,055 Pediatric Medical Subspecialists, including 199 Child and
Adolescent Psychiatry fellows, received training.
hyde amendment
Question. Mr. Secretary, for more than forty years, Democrat and
Republican-led Administrations, as well as Democrat and Republican-led
Congresses have supported the principle that taxpayer dollars should
not fund elective abortions. As members of Congress, President Biden,
Vice President Harris, and you, Mr. Secretary, all voted in favor of
funding bills year after year that included this prohibition. It
remains unclear why this radical change in public policy is suddenly an
imperative for the Biden Administration to fund elective abortions with
taxpayer dollars. Further, your request does not detail the cost this
change will have on the U.Ss taxpayer. Can you please provide an
estimate of how many abortions would receive Federal funding, and what
amount of Federal expenditures would be incurred to pay for abortions,
relative to current law for this fiscal year and the next ten?
Answer. The Hyde Amendment disproportionately impacts the growing
number of low- income, women of color who are enrolled in Medicaid, and
is a barrier to expanding access to healthcare. That is why the
President's first budget calls for Congress to remove the restriction
from government spending bills.
The Department of Health & Human Services implements the laws that
Congress passes. Implementation of any changes in coverage related to
the President's Budget would depend on the final language Congress
passes. After passage of any legislation, agency staff and counsel
review the language to determine the agency's authority and options for
implementation action, such as initiating notice and comment rulemaking
or issuing guidance documents.
Question. HHS issued a proposed rule in April that would allow
Title X grantees to promote abortion as a form of family planning. The
preamble of the proposed rule cites ``that Planned Parenthood conducted
a major fundraising campaign with the 2019 Title X regulatory changes
as its key motivating message. If funds are more efficiently gathered
and distributed via a program such as Title X than through such private
campaigns, the efficiency would represent a cost savings attributable
to the proposed rule.'' It is widely known that Planned Parenthood
walked away from the Title X program in 2019, so I am troubled by the
fact that HHS' proposal implies that Planned Parenthood is somehow
entitled to taxpayer funding. This notion and the rush to finalize the
proposed rule also raises questions about your agency's ability to be
impartial in awarding of future Title X grants. How is this proposed
rule not a kickback to Planned Parenthood?
Answer. On January 28, 2021, President Biden issued a ``Memorandum
on Protecting Women's Health at Home and Abroad'' directing the
Department to review the 2019 Title X Final Rule and ``consider, as
soon as practicable, whether to suspend, revise, or rescind, or publish
for notice and comment proposed rules suspending, revising, or
rescinding, those regulations, consistent with applicable law,
including the Administrative Procedure Act.'' The memorandum stated
that undue restrictions on the use of Federal funds have made it harder
for women to access medical information.
After conducting an extensive review and consideration of the 2019
Title X Final Rule (84 Fed. Reg. 7714) pursuant to the Presidential
memorandum, the Department published a Notice of Proposed Rulemaking
(NPRM) entitled ``Ensuring access to equitable, affordable, client-
centered, quality family planning services'' in the Federal Register
that was open for public comment from April 15, 2021 to May 17, 2021.
As outlined by the Title X statute and reinforced in its
regulations, ``None of the funds appropriated under this title shall be
used in programs where abortion is a method of family planning.''
Consistent with the program's statute and regulations, any public or
private nonprofit organizations, including faith-based organizations,
state, county, local, and tribal governments, school districts, and
public and state higher education institutions are eligible to apply
for Title X grant funds. Title X's regulations, in the NPRM, also
clearly define the criteria the Department uses to decide which family
planning services projects to fund and in what amount.
psychological clinical science accreditation system
Question. The fiscal year 2021 Appropriations Joint Explanatory
Statement encouraged HHS to ``review the accreditation and eligibility
requirements for the Public Health Service Corps and behavioral health
workforce programs to allow access to the best qualified applicants,
including those who graduate from Psychological Clinical Science
Accreditation System (PCSAS) programs.'' Currently, there are more than
40 PCSAS University accredited doctoral programs in psychological
clinical science, including Washington University in St. Louis, but the
Department's guidance and regulations were adopted prior to the
establishment of PCSAS and do not permit the graduates of PCSAS
programs to be eligible to compete for these funding opportunities.
What is the status of this review and updates at the Department and
within the Health Resources and Services Administration, as it relates
to the behavioral health workforce programs?
If this process has not yet started, please provide an explanation,
an estimated start date, and any additional information that may be
necessary to proceed.
Answer. HRSA is currently exploring options to include PCSAS
doctoral programs as eligible entities in the upcoming fiscal year 2022
Graduate Psychology Education competition. HRSA will continue to
explore options to include such programs in other future competitions,
including, but not limited to, the Behavioral Health Workforce
Education and Training program, and the Geriatric Academic Career
Awards. HRSA currently anticipates posting the Notice of Funding
Opportunity for the Graduate Psychology Education program in November
2021.
provider relief fund (prf)
Question. Mr. Secretary, Congress provided $178 billion over the
course of the last year for the Provider Relief Fund, and the American
Rescue Plan included an additional $8.5 billion for rural providers.
How is HHS planning to distribute the approximately $50 billion
remaining, and when can we expect to see the distribution?
Answer. HHS is committed to distributing the remaining provider
relief payments as quickly, transparently, and equitably as possible
while utilizing effective safeguards to protect taxpayer dollars.
HHS is planning for future Provider Relief Fund (PRF) allocations,
including the $8.5 billion from American Rescue Plan Act and Phase 4 of
the General Distribution.
HHS is actively considering feedback from stakeholders, as well as
operational lessons learned from prior PRF payments, as part of the
planning process. The feedback from Members of Congress and other
stakeholders informs HHS' ability to administer the PRF in a manner
that bolsters the healthcare system and helps providers experiencing
COVID-related financial hardships during this crisis. HHS will publish
additional information on future distributions on the Health Resources
and Services Administration's PRF webpage, at www.hrsa.gov/provider-
relief, as soon as it becomes available.
Question. How are you planning to account for the ongoing needs of
rural hospitals and rural healthcare providers in the distribution of
the $8.5 billion?
Answer. HHS is working to finalize the $8.5 billion in American
Rescue Plan Act of 2021 funding for rural Medicare and Medicaid
providers and suppliers. HHS will publish additional information on
future distributions on the Health Resources and Services
Administration's PRF webpage, at www.hrsa.gov/provider-relief, as soon
as it becomes available.
opioids
Question. There is no question that the pandemic has been
challenging for many people and the data shows an unprecedented rise in
opioid overdose deaths in 2020. What can you say about the latest
trends in opioid overdoses and what we need to do to build on the
investments of the last 6 years to combat the opioid epidemic?
Answer. The overdose crisis has certainly worsened in the face of
the COVID-19 public health emergency. Estimates from the CDC find that
more than 90,000 drug overdose deaths have occurred in the 12 months
ending in September 2020. That represents a year-over-year increase of
close to 29 percent. For the last few years, this increase in lives
lost is principally driven by synthetic opioids like fentanyl, but
increasingly, we are seeing stimulants, including methamphetamine and
cocaine also involved. HHS is investing $11.2 billion in programs
responding to the overdose crisis, an increase of $3.9 billion over
fiscal year 2021 Enacted, with the goal of ending the crisis of opioids
and other substance use by increasing funding for States and Tribes for
medication-assisted treatment, and by expanding the behavioral health
provider workforce. Of the $11.2 billion, $6.6 billion is from SAMHSA's
prevention and treatment activities that address the substance use and
opioid crisis, an increase of $2.6 billion over Fiscal year 2021
enacted. HHS is committed to investments in the Substance Abuse
Prevention and Treatment Block grant to expand implementation of
evidence-based prevention, treatment and recovery support services for
individuals, families, and communities across the nation. The budget
includes a new 10 percent set-aside to direct funds to states for
recovery support services, which can be provided prior to, during,
after, and in lieu of treatment. This funding will allow SAMHSA to
serve 2.1 million people in fiscal year 2022 and to significant
strengthen the Nation's recovery support services infrastructure. The
fiscal year 2022 President's Budget also makes significant investments
in First Responder Training programs to train first responders to
respond to and prevent opioid overdose deaths, as well as expanding
treatment for SUD for pregnant and post-partum women.
HHS is committed to continued support for efforts to increase
access to SUD and broader behavioral healthcare services through the
Rural Communities Opioid Response Program (RCORP). The budget includes
a total of $165 million to support prevention, treatment, and recovery
services for opioids and other SUDs in the highest-risk rural
communities. Through RCORP, more than 23,000 individuals received
medication-assisted treatment; and the number of DATA-waivered
providers serving rural communities was increased. In fiscal year 2019
and 2020, the National Health Service Corps Rural Community Loan
Repayment Program (NHSC RC LRP) also served to further increase access
to behavioral healthcare workforce services in rural communities with
651 providers working in rural communities, and 118 of those working
specifically at RCORP service sites.
Other considerations to address the overdose epidemic include:
Treatment Capacity: The SAMHSA-HRSA Workforce projections report
indicates a shortage of over 10,000 full time equivalents for child
psychiatrists and master's level mental and SUD counselors by the year
2025. The report also highlights the need for peer specialists in a
wide variety of integrated and specialty care settings. Peers, as
members of integrated healthcare teams, support all team members in
working at the top of their scope of practice, improving efficiency and
maximizing skill utilization.
Decreasing Barriers: Research reveals geographic and
sociodemographic barriers to receiving treatment.\3\ Indeed, many
treatment facilities are found in urban and suburban areas, and there
is disparity in access to buprenorphine providers and Opioid Treatment
Programs (OTPs).\4\ Recent policy changes, such as The Practice
Guidelines for the Administration of Buprenorphine for Treating Opioid
Use Disorder, remove perceived barriers to obtaining a DATA-2000 Waiver
and expand access to this treatment.. New flexibilities enable more
OTPs to establish mobile medication units (e.g., vans), which can
improve geographic access and expand the provision of opioid use
disorder treatment to disparate populations. Grants such as the State
Opioid Response (SOR), Medicated Assisted Treatment for Prescription
Drug and Opioid Addiction (MAT-PDOA), Targeted Capacity Expansion-
Special Projects (TCE-SP), and Screening, Brief Intervention and
Referral to Treatment (SBIRT) will be used to address this need. The
fiscal year 2022 President's Budget Request proposes increases for each
of these programs.
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\3\ Sharma RN, Casas RN, Crawford NM, Mills LN. Geographic
distribution of California mental health professionals in relation to
sociodemographic characteristics. Cultur Divers Ethnic Minor Psychol.
2017 Oct;23(4):595-600.
\4\ Goedel WC, Shapiro A, Cerda M, Tsai JW, Hadland SE, Marshall
BDL. Association of Racial/Ethnic Segregation With Treatment Capacity
for Opioid Use Disorder in Counties in the United States. JAMA Netw
Open. 2020;3(4):e203711. Published 2020 Apr 1. doi:10.1001/
jamanetworkopen.2020.3711.
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Wrap Around Services Addressing Social Determinants of Health:
These services not only improve the treatment experience, but also
provide support to clients during their recovery. For example, research
demonstrates that women's SUD treatment outcomes are improved when
women-specific needs are addressed through wraparound services, such as
the provision of childcare, employment assistance, or mental health
counseling.\5\ Additionally, the receipt of basic needs, child care,
educational, family, and medical services is associated with
improvements in several outcomes.\6\ These services represent an
important opportunity to support clients and to ameliorate many of
those social determinants of health that precipitate substance misuse.
That is why the fiscal year 2022 President's Budget Request proposes
increase for programs such as the Pregnant & Postpartum Women,
Treatment, Recovery, and Workforce Support, Adult and Family Treatment
Drug Courts.
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\5\ Oser C, Knudsen H, Staton-Tindall M, Leukefeld C. The adoption
of wraparound services among substance abuse treatment organizations
serving criminal offenders: The role of a women-specific program. Drug
Alcohol Depend. 2009;103 Suppl 1(Suppl 1):S82-S90. doi:10.1016/
j.drugalcdep.2008.12.008.
\6\ Pringle, J, et al. The Role of Wrap Around Services in
Retention and Outcome in Substance Abuse Treatment: Findings From the
Wrap Around Services Impact Study. Addict Disord Their Treatment
2002;1:109--118.
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Telehealth: The recent pandemic has demonstrated the utility of
telehealth in reaching disparate populations. Telehealth is a mode of
service delivery that has been used in clinical settings for over 60
years and empirically studied in the mental health space for over 20
years.\7\ Telehealth is not an intervention itself, but rather a mode
of delivering services. This mode of service delivery increases access
to screening, assessment, treatment, recovery supports, crisis support,
and medication management \8\ across diverse behavioral health and
primary care settings. Practitioners can offer telehealth through
synchronous and asynchronous methods. The increase requested under
SAMHSA's SOR grants can be used to address this need.
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\7\ Bashshur, R. L., Shannon, G. W., Bashshur, N., & Yellowlees, P.
M. (2016). The empirical evidence for telemedicine interventions in
mental disorders. Telemedicine and e-Health, 22(2), 87-113.
\8\ Substance Abuse and Mental Health Services Administration.
(2015). Using technology-based therapeutic tools in behavioral health
services. Treatment Improvement Protocol (TIP) Series 60.
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Evidence Based Practice: There is a need for combining leadership
development with organizational strategies to support a climate
conducive to evidence based practice implementation.\9\ This represents
an opportunity to promulgate the evidence and best practices through
SAMHSA publications, reports, and announcements. Beyond this, SAMHSA
will work with grantees to consider implementation science strategies
that support program sustainability and fidelity to the evidence base.
The Evidence-Based Practice Center and Technical Assistance Grants will
be used to address this need. Additionally, the Prevention Technology
Transfer Center Network and the Addiction Technology Transfer Network
will continue to help states develop capacity through training,
consultation, and technical assistance and SAMHSA's new Peer Recovery
Center of Excellence, authorized under Section 7152 of the SUPPORT Act
for Patients and Communities, will continue to provide training and
technical assistance to support integration of peer support workers
into non-traditional settings, build and strengthen recovery community
organizations, a key component of recovery support services
infrastructure. It will also enhance the professionalization of peers
through workforce development, providing evidence-based and practice-
based toolkits and resources to diverse stakeholders.
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\9\ Aarons GA, Ehrhart MG, Moullin JC, Torres EM, Green AE. Testing
the leadership and organizational change for implementation (LOCI)
intervention in substance abuse treatment: a cluster randomized trial
study protocol. Implement Sci. 2017 Mar 3;12(1):29.
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Harm Reduction Activities: The promotion and distribution of
naloxone and fentanyl test strips, similar to the existing syringe
services programs, represents an opportunity to not only promote life-
saving interventions, but to also provide education on drug potency and
mortality.\10\ This might be achieved in partnership with public safety
agencies, providers, community organizations and the public.
Additionally, syringe services programs reduce transmission of HIV and
viral hepatitis within the community. A comprehensive and coordinated
approach must incorporate innovative and established prevention and
response strategies, including those focused on polysubstance use.
Among the programs that can support these efforts are the Treatment
Systems for Homeless and Minority AIDS program, both of which request
an increase in funding.
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\10\ Han JK, Hill LG, Koenig ME, Das N. Naloxone Counseling for
Harm Reduction and Patient Engagement. Fam Med. 2017 Oct;49(9):730-733.
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Education: Medical school graduates play a pivotal role in
educating their patients and colleagues; screening, diagnosing, and
treating patients; and modeling positive attitudes to reduce the stigma
attached to SUDs. Research demonstrates that SUD educational
interventions, using various approaches and durations, produce a
positive impact on medical students' knowledge, skills, and
attitudes.\11\ Studies also reveal that simply increasing exposure to
patients with addiction does not provide the formative knowledge
required to identify, treat or even prevent SUDs without the presence
of a concurrent, comprehensive didactic curriculum.\12\ Even as the
overdose crisis deepens, there remains wide heterogeneity in SUD
curricula across medical schools.\13\ This adversely impacts patient
care--a lack of preparedness has been identified as a barrier in the
provision of buprenorphine to patients with opioid use disorder by
early career family physicians.\14\ Moreover, a lack of appropriate
education has also been shown to foster negative attitudes towards the
treatment of SUD with buprenorphine.\15\ Such negative attitudes
adversely impact patient-physician dialogues and contribute to the
under treatment of SUDs by primary care and specialty providers.\16\
Comprehensive and uniform medical school teaching on SUDs, addiction,
and treatment modalities has the potential to overcome these deficits
and to positively impact all graduates and their patients. It also
represents an important area of engagement with academic institutions.
The Provider's Clinical Support System--Universities (PCSS-
Universities) grant will be used to address this need and would be
further supported by the increase proposed in the fiscal year 2022
President's Budget Request.
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\11\ Muzyk A, Smothers ZPW, Akrobetu D, Ruiz Veve J, MacEachern M,
Tetrault JM, Gruppen L. Substance Use Disorder Education in Medical
Schools: A Scoping Review. Acad Med. 2019 Nov;94(11):1825-1834. doi:
10.1097/ACM.0000000000002883. PMID: 31663960.
\12\ Tetrault, J. Improving Health Professions Education to Treat
Addiction: The Time Has Come. The Josiah Macy Jr Foundation, News and
Commentary. May 2018.
\13\ Blanco, C., Wiley, T.R.A., Lloyd, J.J. et al. America's opioid
crisis: the need for an integrated public health approach. Transl
Psychiatry 10, 167 (2020). https://doi.org/10.1038/s41398-020-0847-1.
\14\ DeFlavio JR, Rolin SA, Nordstrom BR, Kazal LA Jr. Analysis of
barriers to adoption of buprenorphine maintenance therapy by family
physicians. Rural Remote Health. 2015;15:3019.
\15\ Tong ST, Hochheimer CJ, Peterson LE, Krist AH. Buprenorphine
Provision by Early Career Family Physicians. Ann Fam Med.
2018;16(5):443-446. doi:10.1370/afm.2261
\16\ Kennedy-Hendricks A, Busch SH, McGinty EE, et al. Primary care
physicians' perspectives on the prescription opioid epidemic. Drug
Alcohol Depend. 2016;165:61-70.
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Reducing Stigma: Stigma can reduce willingness of policymakers to
allocate resources, reduce willingness of providers in non-specialty
settings to screen for and address substance misuse , and may limit
willingness of individuals with SUDs to seek treatment.\17\ Negative
attitudes toward patients with substance use disorder are common among
health professionals, who generally lack adequate education, training
and support structures to effectively serve patients with SUD. Health
professionals' negative attitudes reduced patients' feelings of
empowerment and diminished treatment outcomes. These attitudes resulted
in less provider engagement, a more task-oriented approach to care
delivery, and diminished empathy.\18\ All of these factors may help
explain why so few individuals with SUDs receive treatment. Public
education that reduces stigma and provides information about treatment
is needed. This represents an opportunity to engage across multiple
disciplines and modalities. Among others, PCSS-U and SOR grants seek to
overcome stigma. The fiscal year 2022 President's Budget requested
increases for both programs.
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\17\ Yang LH, Wong LY, Grivel MM, Hasin DS. Stigma and substance
use disorders: an international phenomenon. Curr Opin Psychiatry.
2017;30(5):378-388.
\18\ van Boekel LC, Brouwers EPM, van Weeghel J, Garretsen HFL.
Stigma among health professionals towards patients with substance use
disorders and its consequences for healthcare delivery: Systematic
review. Drug and Alcohol Dependence. 2013;131(1):23-35.
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Partnering With Public Safety Officials And Community
Organizations: Working with law enforcement, community groups,
patients, and treatment teams to address the growing overdose epidemic
has the potential to channel new ideas, data sources, and efforts
towards reducing mortality and use of illicit substances. Such
engagement promotes cross collaboration and encourages the creation of
innovative and community focused interventions, such as pre- and post-
arrest deflection to treatment. Increases proposed to SAMHSA grants
such as the First Responder Training/Rural Emergency Medical Services
can help address this need.
Question. This Subcommittee has worked in a bipartisan fashion to
provide $4 billion in fiscal year 2021 to address the opioid epidemic,
including $1.5 billion for State Opioid Response grants. This is a
flexible grant provided directly to states to use funds as they see
fit. Unfortunately, we continue to hear that states are not spending
those funds in a timely manner. Does HHS know why this is the case?
Answer. The State Opioid Response (SOR) grants give states
flexibility in providing a range of prevention, treatment, and recovery
support services for opioid and stimulant use disorders. The grants
also support infrastructure development to enhance/expand systems of
care. One of the most common reasons grantees attribute spending
challenges to is state procurement processes. Procurement challenges
include state legislative timelines that do not align with Federal
appropriation cycles; reluctance from contract bidders because of the
short duration of the grant (i.e., 2 years); and delays that result
from contract negotiations. Grantees have also cited challenges related
workforce shortages. Additionally, the COVID-19 pandemic has also
impacted states' ability to spend funds.
Question. How does this trend align with the 50 percent budget
increase for SOR?
Answer. The fiscal year 2022 President's Budget increased the State
Opioid Response grant program to allow grantees to enhance and expand
evidence-based opioid and stimulant use disorder prevention, treatment
and recovery support activities currently underway. Additionally,
grantees will have the ability to increase their focus and efforts on
continued areas of need such as workforce development, harm reduction
and public education and training. This will also increase access to
opioid and stimulant use disorder treatment services in states,
territories, and tribes. Within this total, SAMHSA will direct $75
million to the Tribal Opioid Response grant program to specifically
address the opioid substance use needs in tribal communities. This
critical investment will drive funding to States and Tribes to increase
community-level response to the opioid crisis, expand access to
evidence-based treatment and recovery services, and provide targeted
investment to crisis services and recovery support services. HHS is
committed to working to ensure that the SOR program supports states in
addressing and investing in evidence-based treatment and recovery
services for the ongoing opioid and substance use epidemic. SAMHSA is
committed to providing technical assistance to ensure states understand
how they can utilize these funds, as well as oversight to ensure funds
are spent appropriately in a timely manner.
Question. What can be done to increase the spending rates by
states?
Answer. Currently, SAMHSA monitors grantees' program implementation
activities and provides feedback to states when benchmarks are not
being met. SAMHSA also has a wealth of general and targeted technical
assistance resources that SOR grantees may access. For example, the
Addiction Technology Transfer Center (ATTC) Network is a
multidisciplinary resource for professionals in the addiction treatment
and recovery services field. The ATTC Network's mission and vision are
to: accelerate the adoption and implementation of evidence-based and
promising addiction treatment and recovery-oriented practices and
services; heighten the awareness, knowledge, and skills of the
workforce that addresses the needs of people with substance use or
other behavioral health disorders; and foster regional and national
alliances among culturally diverse practitioners, researchers, policy
makers, funders, and the recovery community. SAMHSA also funds the
Opioid Response Network (ORN) which was designed to provide training
and other resources in efforts to address the opioid crisis. The ORN
has local consultants in all 50 states and nine territories to respond
to local needs by providing free educational resources and training to
states, communities and individuals in the prevention, treatment and
recovery of opioid use disorders and stimulant use. SAMHSA has also
extended flexibilities to grantees considering the COVID-19 pandemic
including granting no-cost extensions to give grantees up to an
additional 12 months to use any unexpended funds from the official
grant period.
Question. To respond to the changing nature of the opioid epidemic,
the fiscal year 2020 LHHS bill expanded the State Opioid Response grant
authority to allow states to use funds on stimulants, like cocaine and
methamphetamine. Mr. Secretary, how is the rising use of stimulants
impacting the ability for state and local communities to provide
effective treatment for opioid use disorders?
Answer. The Department has no evidence to suggest that the rise in
use of stimulants is impacting states' ability to provide effective
treatment for opioid use disorders.
It is important to consider stimulant misuse in the context of
polysubstance misuse--increasingly, substances are not used in
isolation. Individuals with polysubstance misuse involving alcohol,
marijuana, opioids, and/or stimulants receive care in a variety of
settings, and often require withdrawal management, psychological and
FDA-approved pharmacological treatment, and monitoring as part of their
care plan.
SAMHSA recently created an Evidence-Based Practice Guide to address
polysubstance misuse. Through a literature review and consensus from
technical experts, SAMHSA identified three effective practices used to
treat polysubstance misuse in adults. These are (1) FDA-approved
pharmacotherapy with counseling; (2) Contingency management (CM) with
FDA-approved pharmacotherapy and counseling, and (3) Twelve-step
facilitation (TSF) therapy with FDA-approved pharmacotherapy. These
treatments should be delivered in a patient-centered and integrated
manner in order to achieve the best outcomes. Many facilities offer
such treatments, and they demonstrate a high level of success.
There currently are no Food and Drug Administration-approved
medications specific for stimulant use disorders, making it important
that behavioral health and healthcare service providers understand and
offer (or offer referrals for) CM or other psychosocial treatments.
Despite an increase in research into psychosocial treatments for people
with stimulant use disorders, currently the only treatment with
significant evidence of effectiveness is CM. Other psychosocial
treatments that have some support (especially if used in combination
with CM) are cognitive--behavioral therapy/relapse prevention,
community reinforcement, and motivational interviewing. These
interventions demonstrate efficacy in treating stimulant use disorder
across age ranges. SAMHSA's State Opioid Response grants allow the use
of Federal funds to provide CM. In treating stimulant use disorder,
clinicians also are recommended to promote harm reduction (especially
because of the high level of contamination of the drug supply with
fentanyl and analogs) through educating about needle exchange programs,
offering naloxone, and encouraging the use of fentanyl test strips, as
these strategies can help save lives.
``ending hiv'' initiative
Question. I was pleased to see the fiscal year 2022 budget increase
of $267 million for the Ending the HIV Epidemic initiative, started by
this Subcommittee in fiscal year 2020. The Trump Administration,
however, was notably more aggressive in their funding requests to
address the HIV epidemic, requesting $716 million in the second year of
the initiative. After the challenging year of the pandemic, where do we
stand as a nation in combatting new HIV infections?
Answer. Although it is too early to assess quantitatively the full
impact of COVID-19 on HIV research, based on listening sessions
conducted by the NIH OAR across the United States, the COVID-19
pandemic has placed a tremendous strain on sustaining research in
general. Basic and translational research unrelated to COVID-19 in
academic settings was suspended for months, severely delaying progress
for trainees and principal investigators. Healthcare workers and
clinical researchers were diverted to the care of COVID-19 patients,
while clinical research resources had to be redirected to COVID-19.\19\
Recruitment and staffing for HIV and other clinical trials was halted
due to distancing, travel restrictions and ``lockdown'' measures.
Broadly, public health measures required to control the spread of
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have led
to societal restrictions that have negatively impacted the economy and
limited access to routine non-emergency healthcare. Specifically, the
COVID-19 pandemic has had a negative effect on HIV testing, linkage to
care, and access to treatment and HIV research laboratories and
investigation sites.
---------------------------------------------------------------------------
\19\ nature.com/articles/s41581-020-00336-9.
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Preliminary reports suggest that COVID-19 is likely to affect key
HIV study outcomes. For example, adverse events may be caused by SARS-
CoV-2 infection or by deferral of care for other health issues due to
fear of contracting SARS-CoV-2 infection. Research study participants
likely changed their lifestyles to minimize contact with others, which
may affect research outcomes. SARS-CoV-2 infection could worsen HIV
comorbidities, such as glycemic control in persons with diabetes, blood
pressure control in those with hypertension, or accelerate progression
of chronic kidney disease.\20\
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\20\ academic.oup.com/jid/advance-article/doi/10.1093/infdis/
jiab114/6167835.
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The impact of COVID-19 on HIV research has been bidirectional.
Contributions by the HIV researchers and community to COVID-related
efforts are significant: from the successful mRNA vaccine platform, to
clinical trials networks for testing candidate vaccines, to rapid
testing and molecular epidemiology for tracking--the HIV research
footprint is widely recognized in the response to COVID-19. In
addition, there have been some positive aspects related to the COVID-19
response, such as the accelerated innovations that have advanced the
way we conduct clinical research overall. These include new approaches
to conduct remote visits by telehealth, use home-based testing or
monitoring technologies. The NIH OAR HIV and COVID-19 Taskforce is
meeting to discuss further impacts of the COVID-19 pandemic on HIV
research progress and investigator retention within the NIH extramural
community.
Question. What factors were considered for the fiscal year 2022
funding request? Please provide an updated cost estimate of resources
needed over the next 5-years, by fiscal year and Operating Division for
the Ending the HIV Epidemic initiative.
Answer. The Centers for Disease Control and Prevention (CDC)
developed a methodology to estimate the number of people who need to be
tested, diagnosed, and provided HIV medical care and treatment or PrEP.
The CDC's methodology then informed the initial EHE budget for HRSA,
which was developed to meet the EHE goal of enrolling newly diagnosed
and people with HIV no longer in care into EHE-funded medical,
treatment, and support services.
CDC provided data to HRSA on the number of diagnosed people with
HIV in each Eligible Metropolitan Area, Transitional Grant Area, or
State (not just the county of interest). HRSA then used CDC estimates
for the percent of people with HIV who are undiagnosed in each state to
calculate estimated undiagnosed. Using this data, overall cost
estimates were then developed using the average RWHAP costs per person
served.
The HRSA cost estimates for the EHE initiative are outlined in the
table below. The Health Center fiscal year 2022 budget request for the
EHE Initiative was developed in the context of increasing participation
in the Phase I targeted areas. The estimated number of clients served
(reflected below) through the EHE were adjusted from the initial
estimates for the EHE initiative to align with appropriated funds.
Projections for fiscal year 2023 and beyond are under development.
[Dollars in millions]
------------------------------------------------------------------------
Fiscal Year
-------------------------------
2021 Enacted 2022 Budget
------------------------------------------------------------------------
Health Centers.......................... $102.25 $152.25
HAB EHE................................. $105.00 $190.00
-------------------------------
Total............................... $207.25 $342.25
-------------------------------
Estimated Clients:
Budget Health Centers (PrEP)............ 285,000 425,000
HAB EHE................................. 27,000 50,000
------------------------------------------------------------------------
Question. The jurisdictions involved in the Ending the HIV Epidemic
program have invested significant resources. Do you anticipate any
changes to the geographic distribution of the funding?
How does the initiative account for new HIV outbreaks, such as
what's happening in West Virginia, which wasn't one of the seven
targeted states?
Answer. No, HRSA does not anticipate any changes to the geographic
distribution of funding in fiscal year 2022.
HRSA health centers continue to make HIV prevention technical
assistance and training available nationwide, including those centers
with increasing HIV prevalence in their communities. In total for
fiscal year 2020, health centers across the U.S. reported providing
approximately 2.5 million HIV tests and PrEP related services to
389,000 health center patients.
HRSA also responds to HIV outbreaks through the RWHAP's established
care, treatment and support systems in partnership with the CDC. Since
2015, HRSA's RWHAP has worked closely with CDC to address HIV outbreaks
that have resulted from injection drug use, such as what is happening
in West Virginia. This collaboration has been crucial in helping states
and local communities identify those at risk for HIV due to injection
drug use, getting at-risk individuals tested for HIV and hepatitis C,
and getting people linked to and engaged in services for HIV and
hepatitis care or for pre-exposure prophylaxis, substance use disorder
treatment and other needed services.
supplemental and reconciliation funding
Question. In response to the COVID-19 pandemic, states have
received billions of dollars in aid, with the intent of giving them
maximum flexibility to respond to their unique needs and challenges. It
is my understanding there is a sizable portion of unobligated funds
remaining from the bipartisan emergency supplemental bills. And now
there is even more funding provided for similar activities as part of
the partisan reconciliation bill. While it is important to know how
fast HHS is getting this funding into the hands of the frontline
responders on the state level, it is just as important to know if the
states are actually spending the money. What are the spend rates that
HHS is seeing at the state level?
Answer. HHS has awarded over $146 billion to states across six
supplemental appropriations. In many cases, funds were directed to
states by Congress in the COVID supplemental appropriations. As of
early November, award recipients have drawn down $29.5 billion, or
twenty percent, of the total funding awarded. When examining the first
four supplementals, state recipients have drawn down at least 50
percent or significantly higher percentages for resources appropriated
at the earliest stages of the pandemic. Evaluating how the funds are
being used cannot be achieved by examining draw down data alone since
it is not a good indicator of how much jurisdictions have spent. States
and jurisdictions are able to bill again their awards through the end
of the established period of performance for that specific award.
Funding recipients will typically draw down funds as expenses are
incurred or after activities are executed and invoices are reconciled
to confirm reimbursement totals. Drawdowns may occur monthly,
quarterly, or at another frequency depending on the awardee. As a
result there can be a significant time lag in the draw down data since
actual state and jurisdiction expenditures are usually greater than the
amount reflected in our draw down data. HHS grants policies and
regulations require monitoring and award recipient reporting and HHS
agencies closely monitor award recipient performance, activities, and
progress through regular engagement.
Question. What accountability do the states have to tell the
Department how they used the funds?
Answer. With respect to Centers for Disease Control and Prevention
(CDC) grant awards, HHS awarding agencies adhere to HHS Grant Policies
and Regulations, which detail required monitoring and reporting for
award recipients. These may differ in frequency by type of award or
program.
CDC for example continuously and closely monitors recipient/
jurisdiction performance, activities, and progress through regular
engagement. Monitoring activities include routine and ongoing
communication between CDC and recipients, site visits, and recipient
reporting (including work plans, performance, and financial reporting).
Monitoring includes tracking recipient progress in achieving the
desired outcomes, ensuring the adequacy of recipient systems that
underlie and generate data reports, and creating an environment that
fosters integrity in program performance and results.
Monitoring may also include the following activities deemed
necessary to monitor an award.
--Ensuring that work plans are feasible based on the budget and
consistent with the intent of the award.
--Ensuring that recipients are performing at a sufficient level to
achieve outcomes within stated timeframes.
--Working with recipients on adjusting the work plan based on
achievement of outcomes, evaluation results and changing
budgets.
--Monitoring performance measures (both programmatic and financial)
to assure satisfactory performance levels.
CDC complies with HHS requirements to implement internal tracking
methods for issued Federal awards. Award recipients report expenditures
into HHS' Payment Management System (PMS) quarterly and submit a Final
Financial Report 90 days after the end of the budget period. All awards
have assigned budget activity codes that are used to track and monitor
funding
Question. Given the unprecedented amount of funding going out from
HHS as a result of the partisan reconciliation bill, can you explain
HHS' decisionmaking process and planning mechanisms for deploying such
large sums of money in such a short period of time?
How does HHS plan for states and the public health infrastructure
to sustain these advancements when the funding runs out?
Answer. The American Recuse Plan provided over $160 billion for
activities across HHS agencies. The legislation identified specific
purposes for the resources appropriated to HHS agencies and many were
intended to support states public health. In many cases, HHS was able
to leverage existing program mechanisms to efficiently and quickly
execute funding. For example, the American Rescue Plan appropriated
substantial resources for existing block grants within ACF for child
care development, and for mental health and to prevent substance abuse
within SAMHSA. HHS was able to leverage existing program mechanisms to
rapidly award funds when they were needed most by the population served
by these critical programs. These large infusions of funds are
supporting state implemented programs to meet both demands and other
challenges presented during the COVID pandemic. Looking forward, HHS
will work within the Administration to identify future investments in
public health programs through the annual budget process taking into
consideration experiences from the COVID response.
Question. The Administration has placed an emphasis on addressing
health equity, especially as it relates to the pandemic response
efforts. What trends are you seeing in rural communities right now with
regard to the pandemic?
How does the HHS' health equity work account for the needs of rural
communities?
Answer. COVID had a disproportionate impact in rural areas given
limited clinical infrastructure (for example, fewer number of beds,
workforce staffing issues already a challenge pre-pandemic, challenges
accessing PPE). Rural communities suffered with high case rates and
high mortality rates, often worse than in urban areas.
HHS has been intentional about targeting COVID relief to rural
communities (and those populations with at higher risk within rural)--
for example HRSA provided funding to grantees in the Mississippi Delta
Region to promote the vaccine, supported regional trainings for
community health workers in that region as well as the region along the
U.S.--Mexico border, programs that have been proven effective in
populations of racial and ethnic minorities that often face even higher
health disparities than the broader rural populations.
Programs this year targeted Rural Health Clinics and small rural
hospitals to support testing and mitigation activities for these key
providers of the rural health safety net. Additionally, funding to
support vaccine distribution and confidence was distributed to Rural
Health Clinics--getting funding to trusted community providers.
We are enhancing our focus on the need to look at rural health
issues through the lens of health equity; expanding the use of our
research centers to gather more data to inform future work in this
area; and providing targeted outreach to key underserved communities
and populations to help them leverage our funding.
Question. Throughout the pandemic, and to date, we have heard
concerns about the impact to the NIH research community. For example,
scientists who had to close their labs and cull their animals lost
valuable research data and post-doctoral candidates couldn't finish
their research in time to get jobs in September. What is the strategy
for using fiscal year 2021 or fiscal year 2022 dollars for COVID-19
related expenses and how much of non-emergency supplemental funding has
been used by agencies to address these concerns?
Answer. As noted in the question, research on many NIH grants was
impacted by the pandemic, causing delays in research activities and
outcomes. NIH is considering various strategies to address these
coronavirus disease 2019 (COVID-19) related expenses to support our
recipients, such as:
--Providing extensions, both funded and un-funded, for recipients of
NIH Fellowship (F) and NIH Career Development (K) awards who
have been impacted by COVID-19 \21\
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\21\ grants.nih.gov/grants/guide/notice-files/NOT-OD-21-052.html.
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--Supporting administrative supplements, competitive revisions, and
extensions to existing grants
--Allowing extensions to one's early-stage investigator status due to
effects related to pandemic shutdowns \22\
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\22\ nexus.od.nih.gov/all/2020/04/09/can-esi-status-be-extended-
due-to-disruptions-from-covid-19/.
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--Temporary extensions of eligibility for select NIH programs,
including the NIH K99/R00 Pathway to Independence Award \23\
---------------------------------------------------------------------------
\23\ NOT-OD-21-158 and NOT-OD-21-106, and those listed on
grants.nih.gov/policy/natural-disasters/corona-virus.htm under
Temporary Extension of Eligibility.
---------------------------------------------------------------------------
--Flexibilities for NIH-funded clinical trials and human subjects for
the duration of the declared public health emergency \24\
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\24\ NOT-OD-20-087 and grants.nih.gov/sites/default/files/
Considerations-New-Ongoing-Human-Subjects-Research-During-the- COVID-
19-Public-Health-Emergency.docx.
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--Flexibilities for assured institutions for activities of
institutional animal care and use committees \25\
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\25\ 25 NOT-OD-20-088.
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The budgetary impact of these flexibilities and additional funding
on new grants funded is not yet fully known. NIH will continue to
analyze the data on the impact of COVID-19 on the biomedical research
community, and its potential impact on our budget and grant activities.
NIH received the authority in Section 152 of the Continuing
Resolution signed into law in September 2020 to extend multi-year
funded grants awarded in fiscal year 2015, specifically for those
active when the COVID-19 public health emergency was declared.\26\ The
project period end dates for those limited number of awards were
extended through August 31, 2021. NIH is also requesting a similar
extended disbursement authority for certain amounts available for
obligation through fiscal year 2016 that were obligated for multi-year
research grants, such that those amounts would continue to be available
through fiscal year 2022.
---------------------------------------------------------------------------
\26\ 26 Section 152. (a) Funds made available in Public Law 113--
235 to the accounts of the National Institutes of Health that were
available for obligation through fiscal year 2015 and were obligated
for multi-year research grants shall be available through fiscal year
2021 for the liquidation of valid obligations incurred in fiscal year
2015 if the Director of the National Institutes of Health determines
the project suffered an interruption of activities attributable to
SARS--CoV--2. (b)(1) This section shall become effective immediately
upon enactment of this Act.
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influenza
Question. Influenza occurs seasonally each year, and has on
occasion caused devastating pandemics in the past. Reports are already
speculating that the next flu season may be bad after a year of hardly
any flu cases. The budget requests an increase of $25 million for CDC
Influenza Planning and Response and an increase of $48 million for
ASPR's Pandemic Flu program. Are these resources sufficient to meet the
needs outlined in the U.S. National Influenza Vaccine Modernization
Strategy, which projected far greater needs over 10 years?
How will the budget request advance the National Strategy?
Answer. The budget request aligns with and supports the pandemic
influenza strategy. The key investments you note are also critical down
payments to incorporate what we are learning in the ongoing COVID-19
response. Specifically, the budget provides $335 million, an increase
of $48 million above fiscal year 2021 enacted, for pandemic influenza
preparedness activities carried out by ASPR and the Office of Global
Affairs (OGA). ASPR will continue to support priorities in the 2019
Executive Order, ``Modernizing Influenza Vaccines in the United States
to Promote National Security and Public Health,'' and apply lessons
learned from the COVID-19 response to improve pandemic influenza
response capabilities. Through established public-private partnerships,
ASPR will advance non-egg-based vaccine platforms, including more
flexible manufacturing technologies (e.g., cell-based and recombinant
technologies) that can produce influenza vaccine more quickly in the
event of a pandemic. The budget also supports the development of
alternative devices for vaccine administration to allow for rapid,
large-scale vaccinations. The COVID-19 pandemic response has
demonstrated the importance of therapeutics that can prevent
progression to severe disease and treat severely ill individuals.
ASPR will continue to support the advanced development of new
influenza therapeutics and diagnostic platforms to allow for earlier
detection and, subsequently, faster treatment of influenza infections.
OGA will continue to enhance international influenza preparedness by
providing strategic coordination and technical expertise on health
policy development and diplomacy to global partners, including nearly
200 Ministries of Health.
In addition, CDC provides technical expertise, resources, and
leadership to support diagnosis, prevention, and control of influenza
domestically and to address the threat posed by seasonal and pandemic
influenza. The fiscal year 2022 Centers for Disease Control and
Prevention budget request invests an additional $25 million to continue
supporting implementation of the influenza planning and response
activities outlined in the 2020-2030 National Influenza Vaccination
Modernization Strategy. These activities include expanding vaccine
effectiveness monitoring and evaluation, enhancing virus
characterization, and expanding vaccine virus development for use by
industry, increasing genomic testing of influenza viruses, and
increasing influenza vaccine use.
______
Questions Submitted by Senator Richard C. Shelby
Question. On August 2, 2019, the Centers for Medicare and Medicaid
Services (CMS) finalized the Inpatient Prospective Payment System
(IPPS) payment rule, which updated Medicare payment policies for
hospitals in states with a low Area Wage Index (AWI). CMS's AWI
calculation has plagued states like Alabama since its inception. Prior
to the IPPS rule being finalized in August 2019, Alabama had the lowest
AWI floor and ceiling of any state in the country, around .66 and .8
respectively. The IPPS rule made formula changes to Medicare's AWI for
fiscal years 2020--2024, which have benefitted several states to this
point, including Alabama, by boosting annual hospital revenue for
Alabama hospitals collectively by $35--$40 million annually, which
saved many rural hospitals from closing their doors prior to the COVID-
19 pandemic.
This is an important issue to all residents of Alabama. The ability
to deliver healthcare in small towns maintains their ability to recruit
businesses to the area. What are your thoughts on the AWI changes that
were made in the fiscal year 2020 IPPS final rule?
Answer. The Inpatient Prospective Payment System (IPPS) pays
hospitals for services provided to Medicare beneficiaries using a
national base payment rate, adjusted for a number of factors that
affect hospitals' costs, including the cost of hospital labor in the
hospital's geographic area. This adjustment, or Area Wage Index, is
updated by CMS annually.
In the fiscal year 2020 IPPS Final Rule,\27\ to help mitigate wage
index disparities between high wage and low hospitals, CMS adopted a
policy to increase the wage index values for certain hospitals with low
wage index values (the low wage index hospital policy). This policy was
adopted in a budget neutral manner through an adjustment applied to the
standardized amounts for all hospitals. CMS also indicated that this
policy would be effective for at least 4 years, beginning in fiscal
year 2020, in order to allow employee compensation increases
implemented by these hospitals sufficient time to be reflected in the
wage index calculation. For fiscal year 2022, CMS is continuing the low
wage index hospital policy.
---------------------------------------------------------------------------
\27\ Final Rule (CMS-1716-F) and Correction Notice (CMS-1716-CN2)
available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-
Payment/AcuteInpatientPPS/fiscalyear2020-
IPPS-Final-Rule-Home-Page-Items/fiscalyear2020-IPPS-Final-Rule-
Regulations.
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Question. I understand that the pending fiscal year 2022 IPPS rule
includes some significant policy changes regarding organ
transplantation, which could yield a significant negative impact to
transplant centers. Constituents have told me that the rule was written
without input from stakeholders in the transplant community, without
adequate analysis of the impact to patients' access to transplantation,
and without consideration of budgetary impact, if any, on state
Medicaid/CHIP programs. I am concerned about unintended consequences if
this rule were to go into effect, including to access to care,
especially for the children.
Will you ensure that my concerns will be addressed before this rule
is finalized? Will you also engage with all stakeholders on the issues
I've raised?
Answer. The Medicare Program supports organ transplantation by
providing an equitable means of payment for the variety of organ
acquisition services. I can assure you that CMS will take all comments
and concerns into consideration before issuing a final decision on the
proposed Medicare usable organ counting policy.
Question. The overall budget requests $10.7 billion to fight the
opioid epidemic. Previous Administrations have spent billions of
dollars on all aspects of the epidemic including prevention, research,
education, and treatment and there are still severe issues.
Please provide details as to how the Department plans to spend this
money and how it will have a different impact than the money spent
before.
Answer. The budget takes action to address the epidemic of opioids
and other substance use, investing $11.2 billion, including $10.7
billion in discretionary funding, across HHS, $3.9 billion more than in
fiscal year 2021. The impact of this epidemic is felt in our
communities, and the budget will direct funding to states and Tribes to
increase community-level response. The budget will also increase access
to medications for opioid use disorder and expand the behavioral health
provider workforce, particularly in underserved areas. HHS will
continue to build on the investments the American Rescue Plan provided
to the Substance Abuse Prevention and Treatment Block Grant, Community
Mental Health Services Block Grant, and Certified Community Behavioral
Health Centers. This crisis is evolving--overdose deaths involving
substances other than opioids are also increasing. HHS will ensure our
work is responsive to the needs of communities across the country.
Specifically, the $3.9 billion increase in funding includes:
--FDA: +$38 million above fiscal year 2021, for a total of $113
million, to develop opioid overdose reversal treatments and
treatments for opioid use disorder and continue to support
opioid research efforts.
--HRSA: +$190 million above fiscal year 2021, for a total of $1.1
billion to increase behavioral health workforce grant programs
and expand response to the opioid crisis in rural communities.
--IHS: +$27 million above fiscal year 2021, for a total of $42
million to expand activities that increase access to culturally
appropriate opioid use interventions, including medication-
assisted treatment, for American Indians and Alaska Natives
($15 million) and improve prevention and treatment of Hepatitis
C and HIV in tribal communities ($27 million). The prevalence
of Hepatitis C and HIV in Indian Country is closely linked to
rates of injection drug use.
--CDC: +$244 million above fiscal year 2021, for a total of $733
million to address infectious diseases associated with
injection drug use and expand opioid overdose prevention
programs to communities heavily impacted by the overdose
crisis. The additional resources will support collection and
reporting of real-time, robust mortality data and investments
in prevention for people put at highest risk as well as for
testing, diagnosis, linkage to care, and treatment for
infectious diseases related to injection drug use.
--NIH: +$627 million above fiscal year 2021, for a total of $2.2
billion to increase opioid, stimulant, and substance use
research. Within this total, $811 million supports the Helping
to End Addiction Long-term (HEAL) Initiative, NIH's aggressive,
trans-agency effort to provide scientific solutions to the
opioid crisis. Over $1.4 billion supports ongoing research in
this critical area.
--SAMHSA: +$2.7 billion above fiscal year 2021, for a total of $6.8
billion to increase funding for SAMHSA block grants and grant
programs directing funding to local public health response to
the substance use and opioid crisis, including Certified
Community Behavioral Health Clinics. This increase also will
expand access to treatment for pregnant and post-partum women,
access to medication-assisted treatment, access to recovery
support services, and access to drug treatment activities.
--AHRQ: +$7 million above fiscal year 2021, for a total of $10
million for new research grants to increase equity in substance
use disorder (SUD) treatment access and outcomes, accelerate
the implementation of effective evidence-based care in primary
and ambulatory care, and develop whole person models of care
that address the social factors that shape SUD treatment
adherence and long-term recovery.
--CMS: +$12.9 million above fiscal year 2021, for a total of $16.3
million, to increase opioid activities, including funding
certain SUPPORT Act provisions. The funding requested will be
used for data and information technology needs, provider
education, monitoring and auditing, performance measurement,
and claims analysis. CMS will continue to provide technical
assistance to states on behavioral health, developing an
updated opioid and SUD Action Plan, working with the Office of
National Drug Control Policy on the National Drug Control
Strategy, and collaborate with other HHS operating divisions on
opioid and SUD actions, behavioral health, and pain
initiatives.
--ACF: +$40 million above fiscal year 2021, for a total of $140
million to increase state child abuse prevention grant funding
focusing on developing infant safe care plans and expansion of
kinship navigator and regional partnership grants which assist
families at risk due to substance use of a family member.
--ACL: +$1 million above fiscal year 2021, for a total of $3 million
to increase grants for adult protective services and opioid-
related activities to maximize the impact on direct services to
the most affected clients.
The fiscal year 2022 President's Budget provides $713 million for
CDC's opioid overdose prevention and surveillance activities, which is
an increase of $239 million from fiscal year 2021. With the support of
Congress and increases in appropriations in previous years, CDC has
scaled its overdose surveillance and prevention program from 5 states
in 2014 to 47 states, 16 localities, and two territories today.
With the fiscal year 2022 increased funding request, CDC would
continue improving the timeliness and comprehensiveness of drug
overdose data and scaling overdose prevention strategies, evaluation,
and applied research. Because successful response strategies must be
tailored to local communities, CDC would also use the increased funding
to scale local investments so more local communities can quickly
identify changes in local drug supply and prevent overdoses. The
increased funding would also support states and communities that
require additional resources to respond to an increase in overdoses due
to the COVID-19 pandemic.
Question. After significant investment over the past several years,
state Prescription Drug Monitoring Programs (PDMPs) are still not real-
time, not interoperable, and are not incorporated into a provider's
workflow, yet the technology exists to fix all these issues. How does
your budget support improvements to PDMPs and will any funds
specifically support upgrading these systems to address the concerns
I've outlined?
Answer. CDC's goal is to maximize interconnectivity of all
resources within this space. CDC's Overdose Data to Action (OD2A)
program expanded previous Prescription Drug Monitoring Program (PDMP)
investments and has worked to make PDMPs easier to use and more
accessible to both clinicians and under-resourced communities. Under
OD2A, required activities related to PDMPs include:
--Universal use among providers within a state
--Inclusion of more timely or real-time data contained within a PDMP
--Actively managing the PDMP in part by sending proactive or
unsolicited reports to providers to inform prescribing
--Ensuring that PDMPs are easy to use and access by providers
--Propose activities to enhance and maximize the use of PDMPs, such
as moving towards real-time data collection
In addition to the base OD2A funding provided to recipients to
implement required PDMP activities, states were provided with the
option to apply for additional funds to make PDMP data more actionable
both within and across state borders. Activities under this
supplemental funding include integrating state PDMPs with other health
systems data and integrating the PDMP across state lines/interstate
operability.
With Federal funding and substantial technical assistance provided
by CDC, the Bureau of Justice Administration (BJA), the Centers for
Medicaid & Medicare Services (CMS),SAMHSA, and the Office of the
National Coordinator for Health Information Technology (ONC), states
have made significant strides in reporting data faster and achieving
interstate and intrastate PDMP operability, most commonly via the
RxCheck hub or PMP Interconnect. As of May 2021, there are 46
jurisdictions that are live on the RxCheck hub and actively able to
share data across state lines. PMP Interconnect, from the National
Association of Boards of Pharmacy, currently includes 51 participating
jurisdictions. In addition to those jurisdictions sharing data across
states, 45 states and territories are also engaged in intrastate
integration with electronic health records (EHRs), Health Information
Exchanges (HIEs), and Pharmacy Dispensing Systems. CDC collaborated
with other Federal partners to support PDMP/EHR integration in states
through several different projects, including OD2A. CDC also
collaborated with Office of the National Coordinator for Health
Information Technology to select three states (Kentucky, Utah, and
Illinois) as pilots to demonstrate how to integrate PDMP data with EHR
information through the RxCheck Hub.
Currently, only the Oklahoma PDMP has real-time data reporting.
However, 49 state, district, and territory PDMPs have daily or next day
reporting. CDC and BJA funds continue to help states report data
faster. For example, Maine is moving towards real-time PDMP reporting
by using CDC funds to support reporting dispensed controlled substances
no later than the next business day. With fiscal year 2022 funds, CDC's
OD2A program will continue supporting states to improve PDMPs and
maximize interconnectivity. CDC will also support states to increase
data sharing within states, particularly increasing PDMP data within
EHRs and HIEs.
Question. What are your thoughts on continuing the CMS issued
flexibilities around telehealth once the Public Health Emergency has
ended?
Answer. Telehealth is an important tool to improve health equity
and improve access to healthcare. Healthcare should be accessible, no
matter where you live. HHS continues to examine the telehealth
flexibilities developed for the current public health emergency and
determine how we can build on this work to improve health equity and
improve access to healthcare. In addition to looking at which
flexibilities HHS can and should continue administratively, I look
forward to working with Congress to address changes that may need to be
done through legislation.
______
Questions Submitted by Senator Jerry Moran
Question. Before turning to the fiscal year 2022 budget request, I
would like to discuss the remaining money in the Provider Relief Fund.
According to May data from the Health Resources and Services Agency,
there is around $24 billion left in the PRF plus the additional $8.5
billion allocated to rural healthcare providers in the American Rescue
Plan. While HHS has rolled out programs using some of the remaining PRF
funding, I want to ensure the PRF is still serving its original purpose
of protecting healthcare facilities.
Are you considering allocating any of the remaining PRF funds to
assist rural hospitals who may still be struggling in the aftermath of
the pandemic?
Answer. HHS is committed to distributing the remaining provider
relief payments as quickly, transparently, and equitably as possible
while utilizing effective safeguards to protect taxpayer dollars. HHS
is planning for future Provider Relief Fund (PRF) allocations,
including the $8.5 billion from American Rescue Plan Act and Phase 4 of
the General Distribution.
HHS is actively considering feedback from stakeholders, as well as
operational lessons learned from prior PRF payments, as part of the
planning process. The feedback from Members of Congress and other
stakeholders informs HHS' ability to administer the PRF in a manner
that bolsters the healthcare system and helps providers experiencing
COVID-related financial hardships during this crisis. HHS will publish
additional information on future distributions on the Health Resources
and Services Administration's PRF webpage, at www.hrsa.gov/provider-
relief, as soon as it becomes available.
Question. The CARES Act established the PRF to prevent hospitals
from closing during the most severe pandemic mitigation measures and
rural hospitals in particular needed this financial assistance. While
the PRF was largely successful, hospitals that opened in late 2019 did
not receive enough relief and are now strapped for cash. Rock Regional
in Derby, Kansas, which opened just months before the pandemic in 2019,
is one such hospital that deserves more PRF funding under the
guidelines of the Consolidated Appropriations Act of 2021.
Would you consider reopening Phase 3 PRF applications to accept
updated documentation consistent with guidelines of the Consolidated
Appropriations Act?
Answer. In processing PRF applications, HHS has sought to make
payments as quickly and equitably as possible while taking appropriate
precautions to safeguard taxpayer dollars. HHS recognizes that
providers may have questions regarding the accuracy of their PRF
payments. HHS will provide any updates on Phase 3 payments on the
Health Resources and Services Administration's PRF webpage, at
www.hrsa.gov/providerrelief, as soon as they becomes available.
Question. Given the purpose of the PRF, if hospitals are still
struggling, that ought to lead to consideration of a Tranche 4
targeting such healthcare facilities, especially those that opened in
2019.
Is this something you will consider as you look at allocating the
remaining PRF funding?
Answer. As HHS plans for future Provider Relief Fund (PRF)
allocations, including the $8.5 billion from American Rescue Plan Act
and Phase 4 of the General Distribution, we are cognizant that
hospitals that began operating in 2019 and 2020 are facing unique
financial burdens related to the pandemic. Under the previous PRF
distribution payment methodology, HHS paid new providers based on the
average lost revenues and increased expenses for their provider type to
avoid disadvantaging these entities.
As we move forward, HHS is actively considering feedback from
stakeholders, as well as operational lessons learned from prior PRF
payments, as part of the planning process for future funding. The
feedback from Members of Congress and other stakeholders informs HHS'
ability to administer the PRF in a manner that bolsters the healthcare
system and helps providers experiencing COVID-related financial
hardships during this crisis.
HHS will publish additional information on future distributions on
the Health Resources and Services Administration's PRF webpage, at
www.hrsa.gov/provider-relief, as soon as it is available.
Question. I have been concerned with the challenges that the senior
living community has faced throughout the duration of the pandemic.
Long-term care and assisted living facilities were tasked with caring
for the population most vulnerable to COVID-19. In caring for the over
two million seniors across the country, these facilities faced
increasing costs in protecting residents and their staff. As you have
heard me mention before, these senior living facilities have not been
receiving enough support from HHS and are in need of assistance.
Can you confirm that senior and assisted living facilities will
actually see meaningful financial support from the remaining Provider
Relief Fund money in a timely manner?
Answer. As of June 4, 2021, over 10 percent of the total PRF
payments made and kept by providers were directed to nursing homes,
assisted living facilities, and skilled nursing facilities, including
more than $9 billion in PRF Targeted Distribution payments and over $3
billion in PRF General Distribution payments to provider organizations
with at least one nursing home, skilled nursing facility, assisted
living facility, or long term care facility.
HHS appreciates the care being given to seniors across the nation
and recognizes that some assisted living facilities are still
experiencing financial burdens related to the pandemic. HHS is
committed to distributing the remaining provider relief payments as
quickly and equitably as possible while utilizing effective safeguards
to protect taxpayer dollars. At present, HHS is planning a Phase 4 of
the General Distribution. Congress also appropriated an additional $8.5
billion, which has not yet been obligated, in the American Rescue Plan
Act for Medicare and Medicaid providers and suppliers in rural areas or
who serve rural patients.
HHS is actively considering feedback from stakeholders, as well as
operational lessons learned from prior PRF payments, as part of the
planning process. The feedback from Members of Congress and other
stakeholders informs HHS' ability to administer the PRF in a manner
that bolsters the healthcare system and helps providers experiencing
COVID-related financial hardships during this crisis. HHS will publish
additional information on future distributions on the Health Resources
and Services Administration's PRF webpage, at www.hrsa.gov/provider-
relief, as soon as it becomes available.
Question. I would like to ask about your approach to Community
Health Centers. Health Centers in Kansas have been among the leaders in
responding to the COVID-19 pandemic. Since the beginning of the year,
Kansas Health Centers have tested nearly 20,000 patients and
administered vaccines for over 48,000 patients. The fiscal year 2022
budget request mentions the Administration looks forward to working
with Congress to advance the President's goal of doubling the Federal
investment in community health centers. However, the budget also
included a $45 million cut to the overall program due to budget
sequestration.
Could you please discuss HHS' support for greater health center
funding and how you intend to work with Congress to double Federal
investments in community health centers?
Answer. HRSA supports the President's goal to double the Federal
investment in community health centers and looks forward to working
with Congress to expand the Health Center Program to: (1) increase
access to primary medical care services in the high need communities;
(2) ensure that health center patients receive a full range of
comprehensive primary healthcare services; (3) improve health outcomes
and reduce health disparities through new, evidence-based and
innovative approaches to care; and (4) invest in local healthcare
infrastructure and expand employment opportunities in medically
underserved communities.
Question. As I'm sure you're aware, the Children's Hospital
Graduate Medical Education (CHGME) program supports the specialized
training that occurs in many children's hospitals. For example,
Children's Mercy in Kansas City trains the majority of pediatricians
that serve the state of Kansas, instructing nearly 230 pediatric
residents and fellows annually. The fiscal year 2022 budget request
included $350 million for CHGME, marking the first time since fiscal
year 2021 the budget request included a separate request for CHGME.
Could you expand on HHS' goals for the separate funding request and
fiscal year 2022 increase for the CHGME?
Answer. The budget requests $350 million for CHGME to provide
continued support for the pediatric workforce. The funding amount of
$350 million aligns with the fiscal year 2021 enacted funding level and
is expected to support approximately 7,700 resident full-time
equivalents (FTEs). CHGME payments are for direct and indirect medical
expenses for medical residency training programs. The funding will also
support contracts to meet legislative requirements such as the FTE
reconciliation which ensures correct reporting and that residents are
not funded by other Federal programs to prevent duplicate payments.
______
Questions Submitted by Senator John Kennedy
Question. A recent report indicated that HHS has approximately $24
billion in unspent CARES funding. Many healthcare providers are still
working their way through the financial effects of the COVID-19
pandemic, and this funding is crucial.
Can you indicate if healthcare providers, including air ambulances,
can expect to see this funding made available, or will you be returning
unspent CARES funding so that we can reduce the overall financial
impact of spending related to the pandemic response?
Answer. HHS is committed to distributing the remaining provider
relief payments as quickly, transparently, and equitably as possible
while utilizing effective safeguards to protect taxpayer dollars. HHS
is planning for future Provider Relief Fund (PRF) allocations.
HHS is actively considering feedback from stakeholders, as well as
operational lessons learned from prior PRF payments, as part of the
planning process. The feedback from Members of Congress and other
stakeholders informs HHS' ability to administer the PRF in a manner
that bolsters the healthcare system and helps providers experiencing
COVID-related financial hardships during this crisis. HHS will publish
additional information on future distributions on the Health Resources
and Services Administration's PRF webpage, at www.hrsa.gov/provider-
relief, as soon as it becomes available.
Question. If HHS is going to retain unspent CARES Act funds, can it
be used to waive recoupment of Medicare Advanced Payments?
Answer. HHS is committed to distributing the remaining provider
relief payments as quickly, transparently, and equitably as possible
while utilizing effective safeguards to protect taxpayer dollars. HHS
is planning for future Provider Relief Fund (PRF) allocations.
As we move forward, HHS is actively considering feedback from
stakeholders, as well as operational lessons learned from prior PRF
payments, as part of the planning process for future funding. The
feedback from Members of Congress and other stakeholders informs HHS'
ability to administer the PRF in a manner that bolsters the healthcare
system and helps providers experiencing COVID-related financial
hardships during this crisis.
HHS will publish additional information on future distributions on
the Health Resources and Services Administration's PRF webpage, at
www.hrsa.gov/provider-relief, as soon as it is available.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. Secretary Becerra, new data has just been released by
NORC at the University of Chicago finding that nearly two-thirds of
assisted living facilities reported no deaths from COVID-19 in 2020.
Despite this positive data, some have expressed concerns assisted
living providers caring for nearly 2 million elderly individuals have
received less than 1 percent of all provider relief funding to date. It
is my understanding that assisted living providers expended a great
deal of capital in order to ensure COVID-19 safety in their facilities,
as well as to compete for staffing in a tight nursing labor market. I
have been informed that assisted living caregivers will suffer $30
billion in losses through June 2021 due to these efforts and that over
half of assisted living facilities nation-wide are operating at a loss
currently.
How can HHS help support these assisted living providers, through
the PRF and otherwise?
Answer. As of June 4, 2021, over 10 percent of the total PRF
payments made and kept by providers were directed to nursing homes,
assisted living facilities, and skilled nursing facilities, including
more than $9 billion in PRF Targeted Distribution payments and over $3
billion in PRF General Distribution payments to provider organizations
with at least one nursing home, skilled nursing facility, assisted
living facility, or long term care facility.
HHS appreciates the care being given to seniors across the nation
and recognizes that some assisted living facilities are still
experiencing financial burdens related to the pandemic. HHS is
committed to distributing the remaining provider relief payments as
quickly and equitably as possible while utilizing effective safeguards
to protect taxpayer dollars.
HHS is actively considering feedback from stakeholders, as well as
operational lessons learned from prior PRF payments, as part of the
planning process. The feedback from Members of Congress and other
stakeholders informs HHS' ability to administer the PRF in a manner
that bolsters the healthcare system and helps providers experiencing
COVID-related financial hardships during this crisis. HHS will publish
additional information on future distributions on the Health Resources
and Services Administration's PRF webpage, at www.hrsa.gov/provider-
relief, as soon as it becomes available.
Question. Your budget calls for the elimination of the Hyde
Amendment to allow taxpayer funding of abortion through Medicaid,
Medicare, and other programs under Labor/HHS appropriations.
Why is this Administration insistent on reversing four decades of
bipartisan precedent and ignoring the will of most Americans who object
to their tax dollars funding the destruction of human life?
Answer. The Hyde Amendment disproportionately impacts the growing
number of low-income, women of color who are enrolled in Medicaid, and
is a barrier to expanding access to healthcare. That is why the
President's first budget calls for Congress to remove the restriction
from government spending bills.
The Department of Health & Human Services implements the laws that
Congress passes. Implementation of any changes in coverage related to
the President's Budget would depend on the final language Congress
passes. After passage of any legislation, agency staff and counsel
review the language to determine the agency's authority and options for
implementation action, such as initiating notice and comment rulemaking
or issuing guidance documents.
Question. Your budget proposes a 19 percent increase in funding for
the Title X family planning program by $53.521 million to $340 million
from $286.479 million. I am concerned that Title X will be a slush fund
for Planned Parenthood and the abortion industry.
Can you ensure that these new funds will not be used to bolster
abortion giant Planned Parenthood and its cohorts?
Answer. The Title X program does not provide abortion services.
Section 1008 of the Public Health Service Act specifically states that
``None of the funds appropriated under this title shall be used in
programs where abortion is a method of family planning.'' Consistent
with the program's statute and regulations, any public or private
nonprofit organizations, including faith-based organizations, state,
county, local, and tribal governments, school districts, and public and
state higher education institutions are eligible to apply for Title X
grant funds. Title X's regulations, in the NPRM, also clearly define
the criteria the Department uses to decide which family planning
services projects to fund and in what amount.
Question. As you know, the previous administration disallowed $200
million in Medicaid funds from California because it was literally
forcing nuns to buy abortion insurance in violation of conscience
protection laws.
Will you commit to not reversing the findings made by career
professionals supporting the disallowance and not otherwise restoring
the money to California?
Answer. In my ethics agreement signed on January 17, 2021, and the
subsequent authorization issued on March 31, 2021, I have agreed not to
participate in any litigation involving the State of California that
was pending during my tenure as Attorney General. I understand that
there has been no litigation on this matter, however, as Attorney
General I did issue a public statement on the matter. After consulting
with the HHS Acting Designated Agency Ethics Official, I have
determined that it is prudent for me to recuse myself from this
Medicaid financing matter to avoid even an appearance of impropriety. I
trust that the very talented employees of the Department who, at the
working level, handle the vast amounts of work, including specific
enforcement and program financing matters, will resolve this matter in
a manner that is consistent with the Department's obligations and in
the best interest of the American people. If leadership input is
required, the Chief of Staff will either handle the case without any
input from me or will refer the case to the appropriate person for
decision.
Question. Your budget asks for a $9 million increase for the Office
for Civil Rights (OCR), yet OCR inherited over $60 million in
enforcement settlement funds that you are free to use right now to
support the bulk of OCR operations.
Do you think it is appropriate for you to ask Congress for more
taxpayer money for an Office that is sitting on such a huge sum of
money?
Answer. The Health Insurance Portability and Accountability Act of
1996 ( HIPAA) law requires the Office for Civil Rights (OCR) to spend
any money that it collects in HIPAA settlements on HIPAA enforcement
only. This means that these funds are limited in their use as directed
by Congress.
The proposed increase in OCR's budget would support civil rights
authorities and operations, specifically working on improving overall
enforcement stemming from OCR's authority over healthcare.
Question. Will you commit to preserving the Conscience and
Religious Freedom Division as a Division within OCR?
Answer. HHS will continue to protect the religious, civil, and
constitutional rights of all Americans. This means that we will
continue to enforce conscience and religious freedom protections,
including receiving complaints, investigating cases, and making
findings consistent with the law.
Question. A few weeks ago you announced that HHS will interpret
prohibitions on sex discrimination in healthcare to include ``sexual
orientation and gender identity.''
As I read your announcement, male or female are no longer to be
understood as being based on biology. What does it mean to be a man or
a woman going forward under these laws?
Under your announcement, do doctors, who receive HHS funding, have
a right to decline to perform procedures that violate their religious
beliefs or conscience?
Do you favor HHS funds being available for sex-reassignment
surgeries in minors? If so, please explain your justification under
current Federal law.
Do you favor HHS funds being available for puberty blockers and
cross-sex hormones for young children? If so, please explain your
justification under current Federal law.
Answer. HHS will continue to protect the religious, civil,
constitutional rights of all Americans.
Question. As of this week over 60 percent of Americans have
received at least one dose of the COVID-19 vaccine. This extraordinary
milestone was made possible by the unprecedented speed of developing a
vaccine less than 1 year after the start of the COVID-19 pandemic.
However, when the next pandemic hits, the U.S. will need to move even
faster. With the frequency of epidemics and pandemics increasing, the
next fast-moving, novel infectious disease pandemic could occur within
the next 10 years. In addition to naturally occurring threats, rapid
advances in biotechnology increase the chance that novel pathogens
could be created with the potential to start major outbreaks. Given the
uncertainty about how the next pandemic will arise, we must harness
innovative technologies, outside the box thinking, and game changing
science to develop countermeasures that are pathogen-agnostic. In the
fiscal year 2021 House and Senate Committee Reports we included
language that encouraged the Department to work with the Department of
Defense to implement a dedicated medical countermeasures program
focused on developing flexible vaccines and antiviral treatments to
address emerging and previously unidentified infectious disease
threats, referred to as Disease X.
Mr. Secretary, what progress has the Department made in
implementing such a program?
How is the Department planning to develop countermeasures for
previously unidentified viral threats?
Answer. The U.S. Department of Health and Human Services recognizes
the importance of developing flexible, broadly applicable technologies
for the development of medical countermeasures, especially vaccines, to
be able to respond quickly to emerging infectious diseases. The
development of highly adaptable vaccine platforms and structural
biology tools enabling the design of novel and improved immunogens have
helped usher in a new era of vaccinology. In addition, the development
of broadly acting antivirals and other therapeutics will be critical as
we prepare to respond to a future Disease X.
The National Institute of Allergy and Infectious Diseases (NIAID)
at the National Institutes of Health (NIH) supports and conducts
research to both identify previously unidentified viral threats and to
develop medical countermeasures that can be used to respond to them. On
August 27, 2020, NIAID established the Centers for Research in Emerging
Infectious Diseases (CREID), a multidisciplinary global network that
seeks to identify how and where viruses and other pathogens emerge from
wildlife and spillover to cause disease in people. The CREID network,
along with other U.S. Government funded global surveillance efforts,
will enable early warnings of emerging diseases wherever they occur,
facilitate a coordinated outbreak response to an emerging virus, and
may be a crucial tool in early identification of a future Disease X
with pandemic potential. This program will build upon prior U.S.
Government efforts in global disease surveillance and complement
important ongoing activities supported by Federal partners.
NIAID supports basic, translational, and clinical research to
develop novel medical countermeasures, including novel vaccine
platforms, adjuvants, and directly acting oral antivirals. These
medical countermeasures are often developed for broad pathogen families
and can be quickly modified for efficacy against related emerging
pathogens with pandemic potential. NIAID also makes available to the
broader research community a suite of preclinical services that can
help lower the risk to developers and help to advance novel
diagnostics, therapeutics, and vaccines. In addition, NIAID has
leveraged and strengthened global and domestic clinical research
networks to facilitate preparedness for rapid launch of clinical trials
in outbreak situations. These long-standing NIAID investments were
crucial to the response to the emergence of severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19.
For example, the NIAID Vaccine Research Center played a key role in
both the development of novel vaccine platforms and the design of the
stabilized prefusion spike protein immunogen used in all three of the
COVID-19 vaccines currently authorized under an Emergency Use
Authorization from the FDA. The development--in record time--of these
highly efficacious vaccines with the potential for saving millions of
lives was only possible through an extraordinary multidisciplinary
effort leveraging decades of basic, preclinical, and clinical science.
NIH- and NIAID-supported advances in medical countermeasure
research and development, as well as other efforts across HHS to
prepare for novel disease threats, were vital to the Federal response
to COVID-19. Throughout the COVID-19 pandemic, NIH has supported HHS'
efforts to leverage highly productive public-private partnerships with
industry, academia, and the public-sector; utilize longstanding
relationships with community partners to facilitate the biomedical
research response; and engage existing domestic and international
research infrastructure to respond to COVID-19. The whole-of-government
approach that began under Operation Warp Speed and has continued under
the current HHS and Department of Defense Countermeasure Acceleration
Group partnership has efficiently supported the development of safe and
effective COVID-19 medical countermeasures. This effort led to the
rapid identification and clinical testing of candidate therapeutics for
the treatment of COVID-19, as well as multiple COVID-19 vaccine
candidates that progressed in record time from concept to FDA emergency
use authorization. Lessons learned from the Federal response to COVID-
19 will be used to inform future pandemic preparedness efforts at NIH
and across HHS.
In addition to developing platforms that allow for the accelerated
development of vaccines for emerging pathogens, there is a need to move
beyond chasing the different viral strains or variants as they emerge.
NIAID is leading efforts to develop ``universal'' influenza vaccines to
protect against multiple strains of seasonal and pandemic influenza
viruses that may emerge. NIAID also is conducting early-stage research
on the development of pan-coronavirus vaccines designed to provide
broadly protective immunity against multiple coronaviruses, especially
SARS-CoV-2 and others with pandemic potential. New viral threats will
continue to emerge, and the development of universal influenza vaccines
and pan-coronavirus vaccines will help us be better prepared for future
infectious disease threats.
Gaining a deeper understanding of the interplay between pathogens
and the human immune system also could expedite the development of
medical countermeasures against emerging pathogens. NIAID supports a
number of research initiatives to define human immune mechanisms that
provide protective anti-viral immunity or contribute to disease
pathogenesis. For example, the NIAID Vaccine Research Center is
establishing the Pandemic Response Repository through Microbial/Immune
Surveillance and Epidemiology (PREMISE) program. This program will use
data from T and B cell immune surveillance to inform diagnostic,
prophylactic, and therapeutic countermeasures and accelerate the global
response to pandemic threats. NIAID anticipates the research conducted
by PREMISE, and other similar NIAID initiatives, will advance our
knowledge of the immune response to vaccination and infection and help
inform the response to future pandemic threats.
The COVID-19 pandemic is an important reminder of the value of
sustained and robust support for the U.S. biomedical research
enterprise, which continues to accelerate the development of medical
countermeasures to protect against emerging and re-emerging infectious
diseases. NIH remains committed to working with our partners across the
Federal Government to continue advancing the research that will help us
respond to future pandemic threats from Disease X. NIAID will continue
to support the development of flexible vaccine platforms, novel
adjuvants, and antiviral treatments to address emerging and previously
unidentified infectious disease threats. NIAID also anticipates
launching new initiatives focused on preparing for future pandemic
threats from Disease X. These initiatives will continue to build on
long-standing NIAID efforts in this area, as well as lessons learned
from the research response to COVID-19.
Question. As you know from your previous role as a Member of the
Ways and Means Committee, chronic kidney disease (CKD) is unique to
Medicare in that individuals with irreversible kidney failure are
eligible for Medicare regardless of age or other disability. Over its
nearly 50-year existence, this unique coverage has saved tens of
thousands of lives, including 750,000 Americans who currently are on
dialysis or who have a functioning kidney transplant. Individuals with
chronic kidney disease cost Medicare $130 billion in fee-for-service
spending per year, almost $50 million of which is for patients with
irreversible kidney failure. Kidney failure patients represent 1
percent of Medicare beneficiaries but 7 percent of FFS expenditures.
Improving detection and care of early stage CKD can help reduce health
expenditures and improve patients' lives, yet an estimated 90 percent
of our nation's 37 million adults with CKD are unaware they have it.
How will you prioritize changes at your Department to expand the
focus on awareness, early detection, and early treatment to help
prolong kidney function and help ensure the solvency of Medicare?
Nearly 20 years ago, the CDC created the Chronic Kidney Disease
Initiative to increase awareness of the disease and expand public
health surveillance activities. Unfortunately, funding has been mostly
stagnant throughout its history, and it currently receives only $2.6
million, despite the tremendous cost of CKD to society, Medicare, and
Medicaid. The previous Administration created the Advancing American
Kidney Health Initiative, which was very favorably received by the
kidney community. One of the most important goals of AAKH, correlating
to the CDC kidney initiative, was to increase awareness and early
detection of kidney disease via a national kidney disease awareness
public health initiative.
Please comment on efforts to expand the Chronic Kidney Disease
Initiative to meet this awareness and early detection need.
COVID-19 has disproportionately affected kidney patients, who have
experienced some of the highest rates of hospitalization and mortality
from the pandemic. Additionally, COVID-19 is linked to acute kidney
injury (AKI) and to kidney disease in recovering COVID-19 patients who
have no prior history of kidney disease. A March 2021 study from Yale
University indicates that AKI occurred in up to 57 percent of COVID-19
hospitalizations and 78 percent of intensive care unit admissions. In
addition, reports from early in the pandemic indicate that barely a
third of patients who developed AKI had not yet recovered baseline
kidney function at a median of 21 days after leaving the hospital.
(https://www.ajmc.com/view/study-illustrates-kidney-impact-after-covid-
19-resolves)
Without intervention, these patients could develop chronic kidney
disease. What steps will HHS take to ensure COVID-19 patients have
access to the kidney services and care they need going forward?
Answer. Many beneficiaries with end-stage renal disease (ESRD)
suffer from poor health outcomes and face increased risk of
complications with underlying diseases. For example, people with ESRD
who get coronavirus disease 2019 (COVID-19) have higher rates of
hospitalization. Last year, CMS established the End-Stage Renal Disease
(ESRD) Treatment Choices (ETC) Model, a mandatory Medicare payment
model tested under the authority of section 1115A of the Social
Security Act. The ETC Model tests the use of payment adjustments to
encourage greater utilization of home dialysis and kidney transplants,
in order to preserve or enhance the quality of care furnished to
Medicare beneficiaries while reducing Medicare expenditures. This
payment model is expected to encourage participating healthcare
providers to invest in and build their home dialysis programs, allowing
patients to receive care in the comfort and safety of their home. Home
dialysis gives patients the freedom to choose the therapy that works
best with their lifestyles, without being tied to the dialysis
facility's schedule. The ETC Model also includes financial incentives
for participating ESRD facilities and clinicians to encourage
transplantation based on their transplant rate, calculated as the sum
of the transplant waitlist rate and the living donor transplant rate.
Increasing access to affordable coverage will increase access to
care, including preventive services and treatments that prolong kidney
function. The President's fiscal year 2022 Budget includes numerous
provisions that would work together to give Americans additional,
lower-cost coverage options. One provision would give people age 60 and
older the option to enroll in the Medicare program with the same
premiums and benefits as current beneficiaries, but with financing
separate from the Medicare Trust Fund. In States that have not expanded
Medicaid, the President has proposed extending coverage to millions of
people by providing premium-free, Medicaid-like coverage through a
Federal public option.
Question. Sec Becerra, as you know, influenza occurs seasonally
each year and throughout history has caused devastating pandemics--
including the 1918 pandemic that killed an estimated 675,000 Americans.
While this year's flu season was extremely mild, next year's could be
much worse. The U.S. National Influenza Vaccine Modernization Strategy
was released 1 year ago, with an ambitious vision of a domestic
influenza vaccine enterprise that is highly responsive, flexible,
scalable, and more effective at reducing the impact of seasonal and
pandemic influenza viruses. The HHS Budget included a $25 million
increase within CDC's Influenza Division and a $48 million increase for
ASPR Pan Flu.
Are these resources sufficient? The previous administration
estimated $1billion over 10 years would be needed to sufficiently
resource the Strategy.
Answer. ASPR/BARDA has a long and successful history of focused
efforts to invest in increasing influenza vaccine production capacity
in preparation for a pandemic influenza response. While these efforts
benefit seasonal influenza (e.g., cell-based vaccine, recombinant
protein vaccine), they are not specific for seasonal influenza. In
2020, ASPR/BARDA also worked with industry to develop respiratory panel
diagnostics that test for influenza and SARS-CoV-2 infection
simultaneously. ASPR/BARDA looks forward to continuing these efforts as
part of the National Influenza Vaccine Modernization Strategy and
working with our colleagues at NIAID supporting early development of a
universal influenza vaccine.
Question. Sec Becerra, the Administration has requested $30 billion
over 4 years in mandatory funding to protect Americans from the next
pandemic. According to the latest budget request, $24 billion of that
would be allocated to HHS for medical countermeasures manufacturing and
other initiatives.
Please elaborate on the need for this $30 billion investment.
Answer. The President's request for $30 billion over 4 years would
help protect Americans from future pandemics through major new
investments in medical countermeasures manufacturing; research and
development; and related biopreparedness and biosecurity. This includes
investments to shore up our nation's strategic national stockpile;
accelerate the timeline to research, develop and field tests and
therapeutics for emerging and future outbreaks; accelerate response
time by developing prototype vaccines through Phase I and II trials,
test technologies for the rapid scaling of vaccine production, and
ensure sufficient production capacity in an emergency; enhance U.S.
infrastructure for biopreparedness and investments in biosafety and
biosecurity; train personnel for epidemic and pandemic response; and
onshore active pharmaceutical ingredients. COVID-19 has claimed
hundreds of thousands of American lives and cost trillions of dollars,
demonstrating the devastating and increasing risk of pandemics and
other biological threats. The American Rescue Plan serves as an initial
investment of $10 billion. With this new major investment in preventing
future pandemics, the United States will build on the momentum from the
American Rescue Plan, bolster scientific leadership, create jobs,
markedly decrease the time from discovering a new threat to putting
shots in arms, and prevent or mitigate future biological catastrophes.
Question. Will any of these funds be targeted at influenza, which
has the potential for a pandemic even more devastating than Covid-19?
Answer. HHS will follow the requirements spelled out in statute and
follow the latest science in directing resources toward current and
future pandemics.
Question. Please also provide greater clarity into how those funds
would be allocated within HHS.
Answer. HHS is thankful for the resources provided by Congress to
address the COVID-19 pandemic. We will follow the statutory
requirements for use of funds appropriated to HHS and take a broad
approach to addressing COVID-19 by continuing to support research on
prevention, therapeutics, and vaccines; supporting workforce expansion
to ensure equitable distribution of vaccines and therapeutics;
investing in testing and screening to allow our schools and businesses
to remain open; addressing our supply chain and manufacturing
challenges; as well as addressing the mental health of those affected
by COVID-19 whether they lost a family member or friend, suffered
COVID-19, or lost the ability to fully participate in significant life
events over the past 18 months or more. We will invest in the science
and follow the science during this unprecedented time and do our best
to address the challenges it has brought to our public health
infrastructure.
Question. One of the silver linings of this pandemic has been the
wide-spread adoption of technology to bring people together, whether it
be families scattered across the nation or patients and their
providers. We have seen exponential growth in telehealth adoption
across Americans of all ages, locations, and conditions. Telehealth
among Medicare beneficiaries has been made possible by temporary
flexibilities in place for the duration of the public health emergency.
These include allowing Medicare beneficiaries to have telehealth
visits from their home, regardless of where they live across the
country. This has also allowed new types of providers, such as physical
therapists and speech pathologists to practice via telehealth.
Sec. Becerra, do you agree that access to telehealth has been
critical to protecting patients and providers during the nation's
response to COVID-19? b.Sec. Becerra, do you agree that providers and
beneficiaries have seen immense value from expanded access to
telehealth over the past year? Do you agree that Americans have been
overwhelming satisfied with care received virtually during the
pandemic?
Sec. Becerra, can you tell us where telehealth ranks in terms of
your priorities? d.Sec. Becerra, how can Congress ensure that Medicare
beneficiaries do not lose access to telehealth after the public health
emergency expires?
Will you commit to working with Congress to ensure that the
millions of Medicare beneficiaries enrolled in fee-for-service Medicare
do not face a telehealth service coverage cliff when the public health
emergency expires?
Sec. Becerra, as Congress considers permanent telehealth reform, we
will need your support, including an evidence-based assessment of how
many of the telehealth flexibilities extended in response to the
pandemic impacted both the Medicare program and beneficiaries. With
that said, do you believe that there are some telehealth regulatory
restrictions that Congress and HHS can work together to address in the
near term that do not require additional data?
About 46 million Americans, nearly 15 percent of the U.S.
population live in rural areas. Those living in rural areas are more
likely to die prematurely and face higher risks for chronic conditions
like heart disease and diabetes. Americans living in rural communities
face 17 percent higher prevalence of diabetes than those living in
urban areas and may have to wait months before needing to travel great
distances to see an endocrinologist to help manage their condition.
This scenario is not uncommon and instead is the reality of rural
Americans that routinely encounter not just a lack of specialty care,
but in my cases, primary care. Digital health tools, including
telehealth and remote monitoring, have the potential to relieve some of
the key healthcare challenges facing rural America.
Sec. Becerra, can you speak to the promise and value of telehealth
and digital health more broadly to rural communities?
Answer. Telehealth is an important tool to improve health equity
and improve access to healthcare. Healthcare should be accessible, no
matter where you live. HHS continues to examine the telehealth
flexibilities developed for the current public health emergency and
determine how we can build on this work to improve health equity and
improve access to healthcare. In addition to looking at which
flexibilities HHS can and should continue administratively, I look
forward to working with Congress to address changes that may need to be
done through legislation.
Throughout the pandemic, telehealth services have filled an urgent
need to maintain access to care while social distancing was necessary.
For example, federally Qualified Health Centers and Rural Health
Clinics were able to be paid by Medicare as distant site telehealth
service providers, which had not been permitted outside of the COVID-19
public health emergency. After the pandemic, HHS will continue to
support telehealth services. HHS is currently reviewing the telehealth
flexibilities developed for the current public health emergency to
determine which can and should continue after the public health
emergency has ended. HHS plans to continue to support telehealth after
the pandemic through resources like the Telehealth.HHS.gov website and
the Telehealth Resource Centers so patients and providers have access
to telehealth technical assistance.
Question. More than 147 million Americans are living with chronic
conditions. It's estimated that 180 million Americans are living with
mental health challenges. According to a 2017 RAND Corporation Study,
90 percent of the US healthcare spend is on chronic conditions, this
includes $327 billion on diabetes and $131 billion for the treatment of
hypertension. These are staggering figures. I believe that technology
has the potential to empower patients, improve access and allow those
Americans already living with these chronic conditions a chance at a
happier, healthier life. Unfortunately, Medicare has been slow to adopt
innovative digital health tools, some of which has been limited by
outdated statutory limitations.
Beyond telehealth, can you speak to the Administration's efforts to
enable Medicare beneficiaries to leverage digital health tools for the
prevention and treatment of disease?
Are their limitations in your ability to expand access to these
valuable resources for those that want to use them within Medicare?
What do you see CMMI's role to be in facilitating the demonstration
and evaluation of virtual care solutions and digital health tools?
Could you discuss how remote patient monitoring is used today in
Medicare and Medicaid today, in addition to telehealth, to help in the
care of those living with chronic conditions like diabetes,
hypertension, asthma or kidney disease?
Remote patient or physiologic monitoring (RPM) has shown great
value in facilitating the management of both acute and chronic
conditions. Using connected devices, individuals can, in real time,
have data shared back with their care team to allow for intervention
and ultimately prevention of more severe health outcomes. While HHS has
begun to allow for the reimbursement of RPM, use of the codes in
Medicare fee-for-service remains rather low.
Do you see value in enabling adoption of additional virtual care
technologies, such as remote monitoring, for Medicare beneficiaries?
From a health equity perspective, what more can be done to make
resources like remote monitoring tools available to all Americans,
especially those living with chronic conditions?
RPM solutions, which for someone with diabetes, may be leveraged
for years, warrants a recurring monthly 20 percent copay. Is there
value in revisiting copay structures for remote monitoring and chronic
care management services?
Answer. Innovation is important to advancing goals in healthcare,
including by learning how to better leverage digital health tools for
the prevention and treatment of disease. Individuals with chronic
disease benefit from access to comprehensive and coordinated care to
manage and treat their chronic conditions and prevent the need for more
costly care. Ensuring access to remote patient monitoring services,
including through evaluating the adequacy of payments, will be
important to beneficiaries who may benefit from these and other virtual
services that allow their physicians to help manage and treat their
health conditions outside of regular office visits. The CMS Innovation
Center is integral to the Administration's efforts to promote high-
value care and encourage healthcare provider innovation, including
virtual and digital health innovation. I look forward to hearing from
Congress on ideas to change coinsurance for Medicare covered services.
______
Questions Submitted by Senator Marco Rubio
Question. I am incredibly concerned about the Biden
Administration's decision to upend decades of bipartisan agreement by
failing to include the Hyde Amendment in the proposed budget.
Does the Administration support taxpayer-funded abortion?
When Congress likely rejects this radical proposal and includes the
Hyde Amendment in future spending bills--will the Administration follow
the law and ensure that Federal Medicaid dollars are not used to
finance abortions?
Answer. The Hyde Amendment disproportionately impacts the growing
number of low- income, women of color who are enrolled in Medicaid, and
is a barrier to expanding access to healthcare. That is why the
President's first budget calls for Congress to remove the restriction
from government spending bills.
The Department of Health & Human Services implements the laws that
Congress passes.
Question. Of additional concern, the NIH announced that it will end
its Ethics Advisory Board for reviewing external research applications
for Federal funding involving the use of human fetal tissue.
Why has the NIH moved to end the Ethics Advisory Board?
What plan does the NIH have in place to provide adequate oversight
and ensure Federal laws are followed?
Answer. NIH's mission is to seek fundamental knowledge about the
nature and behavior of living systems and apply that knowledge to
enhance health, lengthen life, and reduce illness and disability. Under
its broad research mission, and as authorized by the Public Health
Service Act, NIH conducts and funds biomedical research involving the
study, analysis, or use of human fetal tissue for a range of diseases
and conditions. NIH also funds research to develop, demonstrate, and
validate experimental models that are alternatives to the use of human
fetal tissue.
Given the current administration taking a different position on the
merit of this research, the U.S. Department of Health and Human
Services decided to rescind the 2019 decision that all research
applications for NIH grants and contracts proposing the use of human
fetal tissue from elective abortions will be reviewed by an Ethics
Advisory Board. So on April 16, 2021, NIH published an Update on
Changes to NIH Requirements Regarding Proposed Human Fetal Tissue
Research (NOT-OD-21-111),\28\ stating that HHS was reversing its 2019
decision that all research applications for NIH grants and contracts
proposing the use of human fetal tissue from elective abortions will be
reviewed by an Ethics Advisory Board. Accordingly, HHS/NIH will not
convene another NIH Human Fetal Tissue Research Ethics Advisory Board.
Please note that all other requirements described in NOT-OD-19-128 \29\
and updated in NOT-OD-19-137 \30\ for extramural research remain
unchanged. Furthermore, NIH reminded the scientific research community
of expectations to obtain informed consent from the donor for any NIH-
funded research using human fetal tissue, and of continued obligations
to conduct such research only in accord with any applicable Federal,
state, or local laws and regulations, including prohibitions on the
payment of valuable consideration for such tissue.\31\ The same
requirements apply to the NIH intramural research program.
---------------------------------------------------------------------------
\28\ grants.nih.gov/grants/guide/notice-files/NOT-OD-21-111.html.
\29\ grants.nih.gov/grants/guide/notice-files/NOT-OD-19-128.html.
\30\ grants.nih.gov/grants/guide/notice-files/NOT-OD-19-137.html.
\31\ grants.nih.gov/grants/guide/notice-files/not-od-16-033.html.
---------------------------------------------------------------------------
All NIH-supported organizations certify that they will comply with
the NIH Grants Policy Statement,\32\ which summarizes NIH policies
regarding the use of human fetal tissue in research and incorporates
Federal statutory requirements for research with human fetal tissue
(sections 498A and 498B of the PHS Act, 42 U.S.C. 298g-1 and 298g-2).
---------------------------------------------------------------------------
\32\ grants.nih.gov/grants/policy/nihgps/HTML5/introduction.htm.
---------------------------------------------------------------------------
Question. With much of the country finally moving to pre-pandemic
operations, and as Americans are taking flights, riding trains, and
generally living their lives, all without a Federal vaccine
requirement, there is one industry that the CDC continues to treat
differently.
The White House Press Secretary has stated: ``The government is not
now, nor will we be supporting a system that requires Americans
to carry a credential. There will be no Federal vaccinations
database and no Federal mandate requiring everyone to obtain a
single vaccination credential . . . Our interest is very simple
from the Federal Government, which is American's privacy and
rights should be protected so that these systems are not used
against people unfairly,''
Mr. Secretary, if this were true, then the CDC would not be
restricting cruise activities, and would not be putting unfair guidance
in place that essentially requires that a minimum number of cruise
passengers be vaccinated.
If the Biden Administration wants to protect the rights of
Americans and ensure that policies do not discriminate against certain
Americans, then why does the Biden Administration support vaccine
requirements for cruises that discriminate against families with young
children?
Answer. The Conditional Sail Order (CSO) is a phased approach for
the resumption of passenger operations on cruise ships in the U.S. The
timing of these phases depends on cruise ship operators' demonstrated
ability to mitigate COVID-19 risk on board their ships with crew.
Phases can also be adjusted based on lessons learned from the previous
phases.
Under the CSO, cruise ships are not mandated to require cruise
passengers to be vaccinated. CDC recommended that cruise operators
incorporate COVID-19 vaccination strategies to maximally protect
passengers and crew in the maritime environment, seaports, and land-
based communities to further reduce spread of SARS-CoV-2.
CDC is committed to ensuring that cruise ship passenger operations
are conducted in a way that protects crew members, passengers, and port
personnel, particularly with emerging COVID-19 variants of concern.
Question. When does the Biden Administration plan to end
discriminatory policies that make it more difficult for families with
children to go on vacation?
Answer. CDC currently recommends people delay travel until they are
fully vaccinated. Fully vaccinated travelers are less likely to get and
spread COVID-19 and can now travel at low risk to themselves within the
United States. If people are traveling with children who cannot get
vaccinated at this time, CDC recommends choosing safer travel options.
Question. I assume the vaccine mandate is based on science? If so,
can you elaborate on that science?
Answer. Under the CSO, cruise ships are not mandated to require
cruise passengers to be vaccinated. CDC recommended that cruise
operators incorporate COVID-19 vaccination strategies to maximally
protect passengers and crew in the maritime environment, seaports, and
land-based communities to further reduce spread of SARS-CoV-2. COVID-19
vaccinations significantly reduce the risk of severe illness,
hospitalization, and death.
Question. Does this science also apply to airlines, busses, or
trains?
Why or why not?
Answer. Yes, CDC's science applies in all travel settings. CDC's
current domestic and international travel recommendations suggest
people delay travel until they are fully vaccinated. Fully vaccinated
travelers are less likely to get and spread COVID-19 and can travel at
lower risk to themselves.
______
Questions Submitted by Senator Patrick Leahy
Question. The COVID-19 pandemic has disproportionately impacted
rural hospitals and healthcare providers that were already operating on
shrinking margins. The Department has proposed an increase of $71
million for Rural Health programs to ensure access to high-quality care
that caters to the unique needs of rural communities. This funding is
vital to ensure that our rural providers remain viable.
The COVID-19 pandemic has also exposed serious inequities in
healthcare for BIPOC and underserved populations. Rural communities
have been no exception to this issue. How can any funding proposed for
rural health programs help improve outcomes for BIPOC patients in rural
areas?
Answer. This is an important issue; one fifth of rural Americans
are from a racial or ethnic minority group. The Federal Office of Rural
Health Policy has added language in Notices of Funding Opportunity.
Applicants for rural health grants will be expected to address issues
of equity by targeting underserved communities and populations to
ensure program dollars can reach the people most in need to improve
their health outcomes.
While rural Americans face a range of disparities in terms of
mortality, life expectancy and chronic disease burden, those gaps are
even more pronounced for members of racial and ethnic groups who live
in rural communities, and ensuring the data analysis disaggregates race
and ethnicity, when possible, helps monitor progress toward eliminating
disparities. We will continue to do all we can to make sure rural
communities with populations adversely affected by persistent poverty
or inequality are leveraging our grant programs.
SUBCOMMITTEE RECESS
Senator Murray. This committee will next meet in Dirksen
138 Wednesday, June 16 at 10 a.m. for a hearing on the Biden
administration's budget request for the Department of
Education. The hearing is adjourned.
[Whereupon, at 11:48 a.m., Wednesday, June 9, the
subcommittee was recessed, to reconvene at 10 a.m., Wednesday,
June 16.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2022
----------
WEDNESDAY, JUNE 16, 2021
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10 a.m., in room SD-138, Dirksen
Senate Office Building, Hon. Patty Murray (chairwoman)
presiding.
Present: Senators Murray, Durbin, Reed, Shaheen, Manchin,
Blunt, Moran, Hyde-Smith, and Braun.
DEPARTMENT OF EDUCATION
Office of the Secretary
STATEMENT OF HON. MIGUEL CARDONA, SECRETARY
OPENING STATEMENT OF SENATOR PATTY MURRAY
Senator Murray. Good morning. The Senate Appropriations
Subcommittee on Labor, Health and Human Services, Education and
Related Agencies will please come to order.
Today we are having a hearing on the Biden administration's
fiscal year 2022 budget request for the Department of
Education. Senator Blunt and I will each have an opening
statement. And then I will introduce our witness, Secretary
Cardona. After his testimony, Senators will each have 5 minutes
for a round of questions. And while we are unable to have the
hearing fully open yet to the public or media for in-person
attendance, live video is available on our committee website.
And if you are in need of accommodations, including closed
captioning, you can reach out to the committee or the office of
congressional accessibility services.
Secretary Cardona, after years of proposed budget cuts and
school privatization from your predecessor, this budget would
increase education funding by 40 percent to $103 billion, and
it is a much-needed breath of fresh air. It proposes bold
investments to help our schools and students as they respond to
and recover from this pandemic, and addresses long-standing
inequities in education, which COVID-19 has made even more
damaging.
LOST LEARNING TIME AND DISPARITIES
One of the biggest issues facing our Nation is getting our
students back on track and addressing the lost learning time
that they have experienced. We know students of color, students
with disabilities, students in rural and Tribal communities,
and students from families with low incomes have borne the
brunt of this pandemic.
One study, for example, found the pandemic set students of
color back 3 to 5 months from where they would be in a typical
year, and set white students back 1 to 3 months. We need to
make sure every student, no matter who they are, or where they
live, or how much money they or their family make, can receive
the supports they need to thrive despite this pandemic.
So I am glad this budget takes the task of reckoning with
these inequities seriously, with investments across a range of
programs to help ensure all students can get a quality public
education. It invests $20 billion in a new initiative intended
to reduce disparities in public, elementary, and secondary
education in our country, and proposes to use this funding to
help public schools address a variety of issues, including
inequities in State and local education funding, expanding high
quality preschool programs, and improving outcomes for all of
our students.
INDIVIDUALS WITH DISABILITIES EDUCATION ACT
Of course, improving outcomes for students means we must
also do more to support students with disabilities. This budget
takes an historic step on that front by proposing a $3 billion
increase for the Individuals with Disabilities Education Act.
Over the years, Congress has fallen short of its promise to use
40 percent of the funding to support the education of students
with disabilities through IDEA (Individuals with Disabilities
Education Act).
Currently only 13 percent is provided and struggling States
and districts have been left to fill in the gaps. President
Biden's proposal will help us better keep this promise and help
schools across the country, address the shortage of teachers
for students with disabilities, and provide early intervention
services so students can get the support they need to succeed
as soon as possible.
And when it comes to supporting students' academic, social,
emotional, and mental health needs, this budget proposes a $413
million increase for full-service community schools, an
increase of $120 million for English Language Acquisition
Grants, and a new $1 billion initiative to ensure students have
access to school counselors, nurses, and mental health
professionals.
This is especially critical, given the mental health
challenges students, educators, and school staff have faced
during the pandemic. These challenges will persist well into
the next school year. We need to make investments to support
student and staff wellbeing, and we need to bring in more
counselors, nurses, and psychologists. In Washington State we
only have one school psychologist for every 1,000 students.
This budget will help us tackle inequities in higher education
as well, and significantly expand support for students pursuing
a postsecondary education, including by increasing the maximum
Pell Grant by almost a third.
HIGHER EDUCATION
This is so important. Federal support like Pell Grants
allowed my six brothers, and sisters, and I, to all go to
college. But Pell has gone from covering 75 percent of the
average cost of a 4-year degree at its peak to less than 30
percent today. We have to strengthen and expand Pell. And this
budget is a clear step in the right direction. Ultimately, we
need to do even more to double the maximum Pell award over the
next 6 years, protect Pell from being cut by budget shortfalls,
and expand Pell Grants to more students.
Today, I join colleagues in the House and Senate to
introduce legislation to accomplish all of that. And I hope to
work with you, Secretary Cardona, and my colleagues here in
Congress to get this done. And increased Pell Grants are just
one of several investments, this budget proposes to make higher
education more accessible and affordable for all students,
provides funding to help implement the Bipartisan FAFSA (Free
Application for Federal Student Aid) Simplification Bill I
worked to pass last December.
This will make it easier for all students to apply for
financial aid, including Pell Grants, expand the number of
students eligible for support, and increase financial aid to
students with low incomes. It increases funding for TRIO
programs, which help first-generation college students,
students with disabilities, and students from families with low
incomes to get to and go through college successfully.
It nearly doubles funding for quality campus-based
childcare to support student and parents under the CCAMPIS
(Child Care Access Means Parents in School) Program. And it
provides increased funding for historically under-resourced
colleges and universities, including $345 million, which is a
44 percent increase, in funding for minority serving
institutions, like Historically Black Colleges, and
Universities, and other institutions predominantly serving low-
income students, like community colleges. And finally, this
budget increases funding for the Department's Office for Civil
Rights.
TITLE IX
Between this budget and the public hearings, the Department
started last week on the previous administration's inadequate
Title IX Rule, it is clear we have a President who is focused
on protecting students, no matter their race, ethnicity,
religion, sex, including sexual orientation, and gender
identity, or disability.
I will be watching your work in this space closely, and
encourage the Department to continue its efforts, to hear,
acknowledge and address the stories and concerns of survivors
of sexual assault.
EDUCATION FOR HOMELESS CHILDREN AND YOUTHS
I will say, one area where I would like to see an increased
investment, is funding to support education for children and
youth who are experiencing homelessness. But overall, this
budget is night-and-day different from the previous
administration. I always say a budget is a reflection of your
values. And this budget shows President Biden understands the
money we spend on schools, students, and public education is an
investment in our future. What our Nation accomplishes in the
years ahead will be determined by the opportunities and support
we are able to give children across the country, now.
I look forward to working with the administration and with
my colleagues on this committee to make the investments in
education we need to make so we have a brighter future for our
families.
With that, I will turn it over to Senator Blunt for his
remarks.
STATEMENT OF SENATOR ROY BLUNT
Senator Blunt. Well, thank you, Senator Murray. And welcome
to the hearing, Secretary Cardona. I know this is your first
time to appear before this committee, and I am sure by the end
of the hearing, you will be looking forward to next year when
you get to come back, and the other discussions we will have
between now and then. I am just glad we had a chance to talk,
not only during the confirmation process, but again yesterday,
and look for more opportunities to do that.
Certainly, the last year has been one of the most
challenging years for students, for parents, for school
administrators, for teachers, for everybody in the education
field, including cafeteria workers, and bus drivers who, in a
virtual setting, wound up without a job while everybody else's
jobs became maybe even longer in a day to get ready for the new
challenges of virtual education, where that occurred, and to
try to get back to school, as quickly as they could.
You know, you and I are both first-generation college
graduates, and we have both been classroom teachers, and so I
think because of that, hopefully, we have an understanding of
just how important education is, and what a difference, just a
slight change it points along the way of your trajectory of
where you think your life can take you, can make for the people
we taught, just like we both saw happen with us.
We also understand the critical role education plays in our
society. Our ability to compete around the world, the values
that we transmit from one generation to another, all very
important. I am a proud supporter of many of the programs we
are going to be talking about today, career and technical
education, state grants, IDEA, Title I, the TRIO Programs,
school-based mental health, that you and I talked about
yesterday.
Now I am concerned about the spending level. I just heard
the Chair mentioned the importance of this huge increase of
about 41 percent in spending. I think that increase on top of
the $280 billion in COVID-19 supplemental funding for
education, last year, is a lot of input into the system in a
very short period of time. In fact, last year's spending was
about four times as much as the Department normally receives in
annual appropriations each year. This year the request is
$102.8 billion, which is almost $30 billion, or 41 percent
greater than last year's spending.
It is a lot of money to try to put into the system all at
once. I look forward to hearing your plans and, hopefully, some
of your concerns about how that much new funding going into the
system would go in, in the best possible way. As a former
university president, I am particularly concerned about the
proposal to make community college tuition free for all
students. As, you know, my view is if you want to make a
college education really expensive, make it free, but we will
talk about that.
We will talk about what we are doing now to make it
possible for people to go to college and what you are proposing
in terms of making those first 2 years free at community
colleges. I would point out that in the average community
college in America, if you qualify for the full Pell Grant, you
have more money in that grant than books, fees, and tuition. I
think the average Pell Grant recipient was $3,946, the average
tuition and fees at community colleges was $3,700. I think
there may be other ways to make it possible for more people to
go to community college, and all other schools without cost.
But we are going to talk about that today, and as we move
forward with this budget.
Many States across the country already have programs that
make up the difference, and at a community college in Missouri
the A+ scholarship pays the community college tuition for
eligible students for up to 2 years. I do think those colleges
play an incredibly important role in the country. Both as an
access point for education, but also as a way to get people
ready for jobs that are available, or could be available, in a
specific community.
I am concerned that free community college for everybody
unfairly subsidizes higher-income students. And if it is
community college only, it creates an incentive for students to
attend schools that may not be the best fit for them. Through
the Pell Grant limited taxpayer dollars have targeted students
in the most need. It maintains the ability of students to Pell
Grant, and most of our other programs, to pick institutions
that best meet their individual needs.
Since this committee worked to reinstate year-round Pell
Grants, with Senator Murray and I working hard to lead on that
effort, students have the flexibility to accelerate their post-
secondary studies and complete their programs more quickly.
I am pleased to see that the budget does not include
widespread loan forgiveness. However, the Department has not
outlined a plan at the same time for borrowers to get back into
the repayment process. Federal student loan borrowers have gone
for over a year without being required to make a payment on
their loans. And I think it is important that the Department
begins communicating to those borrowers early and often to
ensure that all borrowers understand their responsibilities,
and their repayment options when a payment or a loan comes due
October 1 of this year. I don't see any discussion about that
in the comments you are making today, and something I would
like to see more thought given to.
I am also concerned that the Department has not announced
how long the student loan servicing will be handled moving
forward, once the legacy servicing contracts end later this
year. We have spent a lot of time in this committee looking at
past proposals on changing that system. As you and I discussed
yesterday, I look forward to hearing your thoughts as to how
that system moved forward.
We both support increased educational opportunities in
every State, such as Title I and IDEA. It is my goal to find
ways we can work together. This budget proposes a 10 percent
increase, or $120 million in discretionary funding for career
and technical education, teamed with $1 billion in mandatory
funding for a New Career Pathways Program. I do think it is
critically important we provide students with meaningful
information about the jobs that are out there with the work-
based learning opportunities and exposure to different career
paths early in high school.
We have been talking about that for some time. There is a
lost decade for so many people from the time they graduate
until the time they really settle in, to the career that
provides the most promise and the most satisfaction for them.
So I look forward to working together on this. I know we
are going to have a number of questions and concerns about this
budget, but it is a critically important part of how people
move forward in our country, giving them those opportunities
and the information they need. And I look forward to working
with you to find the appropriate balance between fiscal
responsibility and meaningful investment that supports access
to quality education for all students.
Thank you, Chair.
[The statement follows:]
Prepared Statement of Senator Roy Blunt
Good morning. Thank you, Chair Murray. And thank you, Secretary
Cardona, for appearing before the Subcommittee today to discuss the
Department of Education's FY2022 budget request.
This has been a long and challenging year for all Americans, but it
has been particularly difficult for students, parents, teachers, school
administrators, and all those in the education field. You and I are
both first generation college graduates and classroom teachers, we know
how much education can change the trajectory of a person's life,
because we saw it in our own lives and in the lives of the people we
taught. We also understand the critical role education plays in our
society and its impact on our nation's ability to compete in a global
economy.
Because of that, I am proud to support key programs that the
Department of Education administers such as career and technical
education state grants, IDEA, and Title I, Part A. However, I am
concerned with the unprecedented level of spending proposed in this
budget request, particularly at a time when Congress has already
provided almost $280 billion in COVID-19 supplemental funding for
education in the last year. For reference, that is about four times as
much as the Department receives in annual appropriations each year.
The FY2022 budget request for the Department of Education is $102.8
billion, which is $29.8 billion, or 41 percent, more than FY2021.
Future generations can't afford this budget. It also invests the
majority of new funding in new programs--and the budget provides few
details on how these programs will work and who will benefit.
As a former university president, I am particularly concerned about
the proposal to make community college tuition ``free'' for all
students. As the saying goes, if you think college is expensive now,
wait until you see what it costs when it's free.
First, for most low-income students who receive a Pell Grant,
community college tuition is already free. Last school year, the
average Pell Grant recipient at a community college received $3,946,
while the average tuition and fees at these schools were only $3,700.
Second, many states across the country already have programs to
make up the difference between a student's Pell Grant and the cost of
community college if there is one. In Missouri, the A+ Scholarship pays
the community college tuition for an eligible student for up to two
years.
Finally, while community colleges play a crucial role in our
diverse higher education system in America, they may not be the best
choice for every student.
Rather than subsidizing higher income students and incentivizing
students to attend schools that may not be the best fit for them, we
should instead focus our investments in programs that make a student's
choice in college affordable. And the best way to do so is through the
Pell Grant program and other programs like the GI bill, work study and
SEOG.
Through the Pell Grant program, limited taxpayer dollars are
targeted toward students most in need. It maintains the ability of
students to pick the institutions that best meets their individual
needs. And since this Subcommittee reinstated year-round Pell Grants in
FY2017, students have the flexibility to accelerate their postsecondary
studies and complete their programs more quickly. This Subcommittee has
boosted the maximum Pell Grant award for the past four years, and I
hope we can do so again this year.
While I am pleased to see that the budget request does not include
widespread loan forgiveness, I am concerned that the Administration has
not outlined a plan to transition borrowers back into repayment when
the student loan pause ends this fall. Federal student loan borrowers
have gone over a year without making a payment on their loans.
It is absolutely imperative that the Department begins
communicating with borrowers early and often to ensure that all
borrowers understand their responsibilities and their repayment options
when a payment or loan come due on October 1, 2021.
As borrowers begin to repay their loans after such a long pause,
student loan servicing will be more important than ever. However, I am
concerned that the Department has not announced how student loan
servicing will be handled moving forward once legacy servicing
contracts end later this year and early next year. This Subcommittee
has worked closely with the Department over the past several years as
it continues to reform and modernize the Federal student loan servicing
system, and I hope that will continue.
Mr. Secretary, while there are issues on which we disagree, we have
many shared priorities that are reflected in the budget request. I know
we both share a strong desire to fund programs that are proven and
benefit all students, and I know we both support increased educational
opportunities in every state, such as Title I and IDEA. It is my goal
for us to work together on many of these and other important issues.
In particular, the budget proposes a 10 percent increase, or $128
million, in discretionary funding for career and technical education,
teamed with $1 billion in mandatory funding for a new career pathways
program. While this Subcommittee will only consider the discretionary
request, I am interested in your ideas for how this and other efforts
could improve educational opportunities for students beginning in high
school, or earlier, to pursue the full-range of post-secondary college
and career opportunities.
Providing students meaningful work-based learning opportunities and
exposure to different career paths early in high school, or even middle
school, can help them identify interests that lead to well-paying jobs
and careers. Too often individuals only find opportunities through
apprenticeships or high-quality credential programs later in life, in
their late twenties or thirties.
I call this the Lost Decade and have provided the Department $10
million each of the past two years to work toward addressing these
issues. I think giving more students access to these opportunities
earlier on is an area of interest for us both, and I hope it is
something we can work on together.
Mr. Secretary, I look forward to working with you this year to find
the appropriate balance between fiscal responsibility and meaningful
investments that support access to quality education for all students.
Thank you again for being here today.
Senator Murray. Thank you, Senator Blunt.
Our witness is today, is Miguel Cardona, Secretary of the
Department of Education. Secretary Cardona, thank you for
joining us today. And I am so glad you could be here. I look
forward to your testimony, and you may begin now.
SUMMARY STATEMENT OF HON. MIGUEL CARDONA
Secretary Cardona. Thank you. Good morning, Chairwoman
Murray, Ranking Member Blunt, and distinguished members of the
subcommittee.
I recently attended an International Thespian Induction
ceremony at a high school where students were being inducted
for their commitment to theater after this long year. My
daughter was one of those students. I can tell you, it was the
first time we came together as a school community in over a
year. So the room was filled with a lot of emotion.
FULFILLING OUR ROLES TO IMPROVE THE EDUCATION SYSTEM
One thing caught my eye, there was a banner hanging that
had a quote from the renowned poet, Alexander Pope, and the
banner read, ``Act well your part, there all the honour lies.''
In other words, do your part, and that is where you will find
the honor.
I come to you today representing the Department of
Education, as we boldly do our part to serve the students
across the country. That is our responsibility and our
privilege. And that is where our collective honor lies.
To that end, I am proud to testify today about President
Biden's fiscal year 2022 budget request for the Department of
Education, because it makes good on the President's campaign
commitment to invest in education. It also begins to address
the significant inequities that students, primarily students of
color, confront every day in schools, in pursuit of higher
education, and career technical education. I want to thank
members of the subcommittee and your staff who have helped
ensure the passage of the American Rescue Plan, bringing vital
resources to our schools and colleges across the country. The
American Rescue Plan funds will ensure that school buildings
reopen for full-time in-person instruction safely and quickly.
EDUCATION AS AN EQUALIZER
I come to you today with a great sense of urgency about the
work we have to do. Generations of inequity have left far too
many students without equitable access to high-quality,
inclusive learning opportunities, including in our rural
communities. Education can be the great equalizer like it was
for me and for many of you, but we have to prioritize,
replicate, and invest in what works for all students. Not just
some.
We must do more to level the playing field, including
providing a strong foundation from birth, improving diversity
among the teacher workforce, creating learning pathways that
work for all students. To that end, the budget proposal calls
on Congress to invest nearly $103 billion in the Department of
Education's programs, a 41 percent increase over the fiscal
year 2021 appropriation to support students' success.
OVERVIEW OF THE BUDGET REQUEST
The fiscal year 2022 request also makes a meaningful down
payment toward the Biden-Harris administration's goal of
reversing inequities. That is what is at stake here, reversing
inequities. The centerpiece is a proposal for a new $20 billion
Title I equity grants program that would address inequities and
disparities between under-resourced schools and their wealthier
counterparts.
It would support competitive compensation for teachers and
Title I schools, expand access to pre-kindergarten, and
increase preparation for, access to, and success in rigorous
coursework. Our requests would put the Nation on a path to
double the number of school counselors, nurses, and mental
health professionals in our schools, and significantly expand
support for community schools to help increase the availability
of wraparound service services to students and families in
underserved schools and communities.
The pandemic reinforced the need for this. We also think it
is past time for the Federal Government to make good on its
commitment to students with disabilities, and their families,
and the request makes a significant move toward full funding of
IDEA, proposing a 20 percent increase for IDEA State grants of
$2.6 billion.
Turning to higher education, an area that needs immediate
attention. Our budget proposal begins the Biden-Harris
administration's critical work to increase access and
affordability for students. The budget proposal coupled with
increased proposals--proposed in the American Families Plan
would be the largest increase to Pell Grant ever, helping
millions of students and families pursue their goals.
Importantly, our proposal would ensure that Dreamers may also
receive Pell Grants if they meet current eligibility
requirements.
The fiscal year 2022 request paints a bold picture for the
future of our institutional and student support programs. The
budget increases institutional capacity and student supports at
minority-serving institutions, with additional funding for
HBCUs (Historically Black Colleges and Universities), Hispanic-
Serving Institutions, Asian-American, and Native-American
Pacific Islander-serving Institutions, and Tribally Controlled
Colleges and Universities, as well as our beloved TRIO and GEAR
UP programs to help ensure underserved students succeed and
graduate from college.
Finally, we would prioritize efforts to enforce civil
rights laws related to education through a 10 percent increase
for the Office for Civil Rights, to protect students and
advance equity and educational opportunity, and delivery in
preschool through college. This is a fundamental right we are
committed to for all students.
Working together with stakeholders, including students and
educators, we can and will heal, learn, and grow together,
during this challenging time. I am committed to working
collaboratively with each of you to strengthen our schools, and
campuses, and to help improve opportunities, pathways, and
outcomes for students across the country, including students in
our rural communities.
Thank you. And I look forward to answering any questions
you may have.
[The statement follows:]
Prepared Statement of Hon. Miguel Cardona
Good morning Chairwoman Murray and Ranking Member Blunt.
I am pleased to join you today, and I am proud to testify on behalf
of President Biden's fiscal year 2022 Budget Request for the Department
of Education. The full fiscal year 2022 Budget Request, which was
released a little over two weeks ago, makes good on President
Biden's campaign commitment to reverse years of underinvestment in
Federal education programs and would begin to address the significant
inequities that millions of students--primarily students of color--and
teachers confront every day in underserved schools across America.
These inequities in opportunity and access continue to be experienced
by students pursuing higher education and career and technical
education credentials as well.
american rescue plan act
Before I begin, I want to thank the Members of the Subcommittee--
and your staff--who helped carry the American Rescue Plan Act to the
finish line. I can tell you from immediate experience that the ARP
funds will make all the difference in ensuring that schools re-open for
full-time, in-person instruction as safely and soon as possible. In
addition, ARP funds will enable schools to address the mental health,
social, and emotional needs of students that the pandemic has laid
bare, and to fully recover from the massive impact of lost
instructional time on student achievement during the pandemic.
The plans to reopen are bold--and will require coordination among
key stakeholders at the Federal, State, and local levels. But they
match the urgency the challenges before us demand. It's important to
remember that once we fully reopen schools, we still have work to do.
Our job will not be done. Generations of inequity have left far too
many students without equitable access to high-quality, inclusive
learning opportunities. Education can be the great equalizer--it was
for me--if we prioritize, replicate, and invest in what works for all
students, not just some.
We must do more to level the playing field, including providing a
strong foundation from birth, improving diversity among the teacher
workforce, and creating learning pathways that work for all students.
To that end, the fiscal year 2022 budget proposal for the Department of
Education provides strong investments in key areas to ensure students
of all ages have what they need to succeed.
department of education funding levels
The President's fiscal year 2022 request calls for a significant
and long-overdue increase in Federal support for education from birth
through college and career. The proposed discretionary request of $103
billion for Department of Education programs, an increase of almost $30
billion over the fiscal year 2021 enacted level, would be complemented
by additional mandatory investments under the American Jobs Plan and
the American Families Plan. We understand that some have raised
questions about the unprecedented increase in Federal education funding
proposed by President Biden, particularly coming on top of emergency
appropriations over the past year to address the impact of the COVID-19
pandemic on our schools. However, it's important to recognize that
these bold proposals follow a decade of virtually no funding growth in
real terms for Department programs, a significant under-investment in
light of the rising needs of students and families.
The $73.5 billion that Congress appropriated for the Department for
the current fiscal year, fiscal year 2021, is about 8 percent more than
the fiscal year 2011 total of $68.3 billion. Title I funding did a
little better, up 10 percent, or 1 percent a year, over the same period
of time. The total Federal investment in elementary and secondary
education grew at the same rate--just 1 percent annually over the past
10 years--not even keeping up with inflation.
funding inequities in state and local education systems
This underinvestment in K-12 education matters because of the
dramatic and longstanding inequities in State and local education
funding systems, which despite more than half a century of litigation
and reform, too often continue to provide significantly less funding
for high-poverty districts and schools, which are more likely to serve
students of color, resulting in a disproportionate impact on these
students. Reversing these funding inequities, as well as immediately
addressing the negative impact of those inequities in service of
students, are critical goals of the Biden-Harris Administration's
racial equity agenda, and the President's fiscal year 2022 request for
the Department of Education would make a meaningful down payment toward
these goals. Addressing these inequities are critical to our nation's
future. Our country and our economy will be stronger when every child
is prepared to succeed in tomorrow's economy, regardless of race, zip
code, their family's income, or disability.
investment in title i grants to local educational agencies
The centerpiece of that request is $20 billion for a new Title I
Equity Grants program--part of the President's commitment to
dramatically increase funding for Title I schools--that would help
address long-standing funding disparities between under-resourced
school districts and their wealthier counterparts; ensure teachers in
Title I schools are paid competitively; support expanded access to
preschool; and increase preparation for, access to, and success in the
rigorous coursework needed to prepare for postsecondary education and
high-paying, in-demand careers. This proposal will further the goals of
Title I as outlined by President Johnson in partnership with Congress
back in 1965 as part of the War on Poverty, to help ensure that all
students--especially students from low-income backgrounds and students
of color in underserved communities--receive the high-quality education
they need to thrive and achieve their dreams.
investment in improving students' physical and mental health
Long before the COVID-19 pandemic there was increasing evidence
that the conditions of poverty--especially concentrated poverty--take a
tragic toll on the physical and mental health of students. This
warrants significant investments in mitigating the impact of this toll
in order to improve student outcomes. Congress recognized this problem,
in part, through the creation and rapid increase in funding for the
Title IV-A Student Support and Academic Enrichment program. Our request
would build on these efforts through a $1 billion investment for a new
School-Based Health Professionals program to support the mental health
needs of our students by increasing the number of counselors, nurses,
and mental health professionals in our schools, and building the
pipeline for these critical staff, with an emphasis on underserved
schools.
community-based programs
In addition, the President's request would help increase the
availability of a broad range of wrap-around services to students and
families in underserved schools and communities through a significant
expansion of the Full-Service Community Schools program, from $30
million in fiscal year 2021 to $443 million in fiscal year 2022. This
program recognizes the role of schools as the centers of our
communities and neighborhoods, and funds efforts to identify and
integrate the wide range of community-based resources needed to support
students and their families, expand learning opportunities for students
and parents alike, support collaborative leadership and practices, and
promote the family and community engagement that can help ensure
student success. The request would support implementation of the
community schools model at roughly 800 additional schools serving up to
2.4 million students, family members, and community members.
Our request also would help strengthen communities by fostering
diverse schools through renewed efforts to improve school racial and
socioeconomic diversity. We would provide $100 million for a new
Fostering Diverse Schools program that would help communities develop
and implement strategies that will build more racially and
socioeconomically diverse schools. Research suggests that diverse
learning environments benefit all students and can improve student
achievement, serve as engines of social and economic mobility, and
promote school improvement. Our proposal also would build evidence
around effective practices for addressing the growing concern that our
Nation's schools are becoming less diverse and more segregated each
year.
support for special education
We also think it is past time for the Federal Government to make
good on its commitment to students with disabilities and their
families, as expressed in the Individuals with Disabilities Education
Act. The President's request makes a significant move toward full
funding of the IDEA with a $2.6 billion, or 20 percent, increase for
IDEA Part B Grants to States above the regular fiscal year 2021
appropriation, for a total of $15.5 billion. Notably, this increase
would raise the Federal share of the excess cost of serving students
with disabilities for the first time in 8 years-demonstrating that IDEA
has been yet another casualty of the Federal underinvestment in
education over the past 10 years.
In addition, we would increase funding for the IDEA Part C Grants
for the Infants and Families program by more than 50 percent, or $250
million above the regular fiscal year 2021 appropriation level, for a
total of $732 million to expand access to early intervention services
for infants and toddlers with disabilities. We would pair this
increased funding with reforms to strengthen the Part C program,
particularly for children who have been historically underrepresented
in the program, including children of color.
The President's Request would also boost the Preschool Grants
program by $105 million over the 2021 appropriation, to aid in the
provision of special education and related services for children with
disabilities aged 3 through 5.
teacher training and support
The Title I Equity Grants proposal is just one demonstration of
President Biden's strong commitment to teachers. Other key investments,
split between discretionary and mandatory American Families Plan
funding, include $412 million ($132 million in discretionary funding
and an additional $280 in mandatory authority for fiscal year 2022) for
Teacher Quality Partnerships to address teaching shortages, improve
training and supports for teachers, and boost teacher diversity,
particularly through investment in teacher residencies and Grow Your
Own programs; $340 million ($250 million in discretionary funding and
an additional $90 million in mandatory authority for fiscal year 2022)
for Special Education Personnel Preparation to ensure that there are
adequate numbers of personnel with the skills and knowledge necessary
to help children with disabilities succeed educationally; and $60
million ($20 million in discretionary funding and an additional $40 in
mandatory authority for fiscal year 2022) to fund for the first time
the Hawkins Centers of Excellence program designed to increase the
quality and number of new teachers of color. In addition, the American
Families Plan would make a one-time mandatory investment of $1.6
billion to support additional certifications at no cost for more than
100,000 educators in high-demand areas like special education,
bilingual education, career and technical education, and science,
technology, engineering, and mathematics. We are also requesting,
through the American Families Plan, $200 million in mandatory authority
for a new Expanding Opportunities for Teacher Leadership and
Development program to support opportunities for experienced and
effective teachers to lead and have a greater impact on their school
community while remaining in the classroom (and be compensated for
additional responsibilities) through such activities as high-quality
teacher mentorship programs and job-embedded coaching. Lastly, the
American Families Plan would double TEACH Grants from $4,000 to $8,000
for future teachers while earning their degrees.
improving career pathways
The President's Request also recognizes that a skilled workforce is
critical for both strong communities and a strong economy by proposing
to make targeted investments that would help build the capacity of our
workforce development system. These investments include an increase of
$108 million in Career and Technical Education National Programs to
support an innovation grants initiative focused on youth work-based
learning and industry credential attainment, along with a $25 million
increase under Adult Education National Leadership Activities to expand
college bridge programs for low-skilled adults without a high school
degree. In addition, the American Jobs Plan would provide $1 billion in
mandatory funding in fiscal year 2022 ($10 billion total over 10 years)
to expand career pathways for underserved middle and high school
students that include partnerships with employers, community colleges
and other partners and allow students to earn credentials or college
credit while still in high school; and also would invest $100 million
annually over the next 10 years to help connect job-seeking adults to
employment opportunities by focusing on foundational skills and
embedded career services.
postsecondary education investments
Turning to higher education, our budget proposal would make
postsecondary education more affordable for students from low-income
households through a $400 increase to the maximum Pell Grant. In
combination with the $1,475 increase to the maximum Pell Grant proposed
in the American Families Plan, the increase in 2022 would be the
largest increase to the Pell Grant ever. This historic increase is just
a first step in a more comprehensive proposal to double the grant.
Importantly, our proposal also would ensure that postsecondary students
who are DACA recipients may receive Pell Grants and other federal aid
if they meet current eligibility requirements.
Through the American Families Plan, our budget proposal would
provide two years of free community college to first-time students and
those wishing to reskill. It would also make college more affordable
for low- and middle-income students at four-year Historically Black
Colleges and Universities (HBCUs), Tribal Colleges and Universities
(TCUs), and Minority Serving Institutions (MSIs) such as Hispanic-
Serving Institutions (HSIs) and Asian American and Native American
Pacific Islander-Serving Institutions (AANAPISIs).
The fiscal year 2022 request also would increase institutional
capacity and student supports at HBCUs, TCUs, and MSIs, and other
under-resourced institutions, such as community colleges. The
discretionary request includes more than $600 million in additional
funding for institutional supports programs and programs like TRIO and
GEAR UP, to help ensure underserved students succeed in and graduate
from college. The American Families Plan also provides historic
mandatory investments over ten years in college access and success,
including $46 billion for HBCUs, TCUs, and MSIs, and $62 billion for a
new Completion Grants program that would make formula grants to States
to support the use of evidence-based strategies to strengthen
completion and retention rates at institutions that serve students from
our most disadvantaged communities like community colleges.
school infrastructure
Too many students attend schools and child care centers that are
run-down, unsafe, and pose health risks. These conditions are dangerous
for our kids and exist disproportionately in schools with a high
percentage of low-income students and students of color. We can't close
the opportunity gap if low-income kids go to schools in buildings that
undermine health and safety, while wealthier students get access to
safe buildings with labs and technology that prepare them for the jobs
of the future. Accordingly, the American Jobs Plan would provide $10
billion in mandatory funding in 2022, and $50 billion over five years,
for grants to upgrade existing school facilities and build new public
elementary and secondary schools. Outside of the Department of
Education, funding would leverage an additional $50 billion in
investments in school infrastructure through bonds. The American Jobs
Plan would also provide $2.4 billion in mandatory funding in 2022, and
$12 billion over five years, for grants to invest in community college
facilities and technology in order to help protect the health and
safety of students and faculty, address education deserts (particularly
for rural communities), grow local economies, improve energy efficiency
and resilience, and narrow funding inequities.
student aid administration
In addition to making college more affordable, our budget proposal
will improve the services we provide students and families to help them
pay for college. We are requesting $2.1 billion to administer the
Federal student aid programs in fiscal year 2022, an increase of $200
million over the fiscal year 2021 appropriation. The requested funds
are necessary to implement the FAFSA(r) Simplification Act and FUTURE
Act, which together will greatly ease the process of applying for
student aid and accessing affordable, income-driven repayment options;
provide high-quality loan servicing to more than 40 million student
loan borrowers; and protect the personally identifiable information of
around 75 million students and parents.
enforcement of civil rights laws
Finally, we would prioritize efforts to enforce the Nation's civil
rights laws, as they relate to education, through a 10 percent increase
for the Office for Civil Rights to protect students, providing a total
of $144 million to advance equity in educational opportunity and
delivery at Pre-K through 12 schools and at institutions of higher
education.
closing remarks
Thank you again for this opportunity to share more about the
President's plan to invest in students of all ages and the institutions
that serve them. I look forward to hearing your reactions to this
historic budget request, and to learning more about your individual
interests and priorities related to Department of Education programs
and activities. I am committed to working collaboratively with each of
you, to the greatest extent possible, to help improve educational
opportunities and outcomes for all students.
Thank you, and I will do my best to respond to any questions you
may have.
RESOURCE ALLOCATION
Senator Murray. Thank you so much, Mr. Secretary. We will
now begin around a 5-minute questions of our witness, and I ask
our colleagues to, please, keep track of your clock. Stay
within those 5 minutes.
Mr. Secretary, the President's budget calls for major
investments in our Nation's public schools, acknowledging the
significant resource disparities between schools serving more
students from families with low incomes and their wealthier
peers. These resource discrepancies contribute to the
achievement gap between students of color who represent more
than half of our students served in Title I schools and white
students. One of the key provisions we included in the
Reauthorization of the Elementary and Secondary Education Act,
is a requirement to review the resource inequities in schools
which have been identified for support and improvement.
And we also included a requirement for per pupil
expenditure reporting for all States and school districts in
the Nation, a requirement that still has not been fully
implemented years after we passed the law. I believe that
combination of additional Federal education investments,
accurate and timely reporting, and thoughtful review of how all
education funds are being allocated and used in schools needing
additional support would improve the quality of education
services for all of our students and families.
I know the pandemic has likely impacted the implementation
of these resource allocation reviews, but can you share your
plans for supporting and monitoring State and local agencies
conducting these reviews, as well as your plans for ensuring
States and school districts do comply with the SEA's (State
Educational Agencies) fiscal equity reporting requirements?
Secretary Cardona. Thank you, Senator Murray. And you start
with an issue that is critically important that we must address
together. The opportunity gaps and achievement disparities and
outcomes are significant, so much so that I have been an
educator for over 20 years, it has almost become normalized.
And we have an opportunity here to address it, with the budget
proposal, and the American Families Plan, there is a
transformational opportunity for our country, to not only
recover from the pandemic, but to be better than we ever were
before in education.
And I look forward to ensuring that every penny that is
allocated is used to support our students in a way that is
equitable. You know, we talk a lot about education being the
great equalizer, well, this budget proposes strategies to get
there. And it is important for me to make sure that while the
resources are there, we have equal amounts of accountability to
make sure that the funds are being used for what they were
intended.
So, absolutely, to me, the work that we do at the agency to
ensure that the funds are being used for what they were
intended for is critically as important as providing resources.
We can't get to equalizing the playing field if the resources
are not being used where they are supposed to.
So I, and the team at the Department of Education, will be
very vigilant, especially with this new American Rescue Plan,
and the funding that has been provided over the last year. We
are going to be vigilant to make sure that the funds are being
used for what they are intended to be used for. And I will add
that as we rolled out the American Rescue Plan, we required
States to provide transparent reports on how they were going to
use the money, and engage stakeholders, so they are a part of
the process early and ensure that equity is at the heart of the
plan.
I envision this being something that is going to help lift
our students. And I look forward to working with you and others
to make sure it happens.
INVESTMENTS TO SUPPORT HIGHER EDUCATION
Senator Murray. Okay. Thank you. And on higher Ed, the
pandemic really exacerbated, as we know, the financial
challenges a lot of our students face pursuing a post-secondary
education. Congress, as you know, responded by providing
significant relief to students and borrowers, including
flexible funding to address students' basic needs during this
pandemic. But as our country begins to recover from this
pandemic, many of the financial strains that are facing
students who are low-income, students of color, student
parents, and first-generation students are really out there for
them.
This is not just the cost of tuition and fees I am talking
about, but housing, food, childcare, unexpected bills that can
quickly derail a student's plans. And as we turn this corner on
COVID, we should redouble our efforts to help all students
pursuing a post-secondary education. And this budget I think is
a positive step in that direction. But can you speak for a
moment about the increases for Pell Grants, and childcare, for
students, parents, TRIO, why those investments are so critical
right now?
Secretary Cardona. Thank you, Senator. We recognize now
that if we don't act with urgency, we are going to lose many of
our students who are thinking about higher education as an
opportunity to continue their growth. The increase in Pell
Grants, which is significant under the American Families Plan,
$1,400, and $400 increase here in this budget show the
commitment that the President has toward ensuring equitable
access to higher education for our students.
And we recognize that that, with other supports, are going
to allow for our students to continue to engage in college,
free community college for students, talk about giving an
opportunity to students who might not even think of higher
education, because it is too far off, or the fear of being in
debt for the rest of their lives. With that said, the pause on
loan repayment has provided--saved over $5 billion a month for
over 41 million borrowers. So we know how critically important
that is. It has covered 1.1 million borrowers in the process,
but programs like the Pell increase provide access to college
for many more students. And we were confident with support of
programs like that, and programs like TRIO, more and more
students will look at higher education as an option for
themselves.
Senator Murray. Okay. Thank you very much.
Senator Blunt.
Senator Blunt. Thank you, Chairman.
FREE COMMUNITY COLLEGE
Secretary, let's talk a little about the first 2 years of
college education being free, or at least if you choose to go
to a community college. I am much more inclined to be receptive
to your arguments about increasing the Pell Grant, increasing
even the level of maybe whether you qualify for that maximum
Pell sooner. What are you thinking about in terms of 2 years of
free community college education?
I am a big supporter of the community college system, every
community college in my State, I believe, understands that, but
I don't quite understand, one, why we want to make community
college free for everybody regardless of need. And then my
second question is going to be: Why just community colleges?
But how do you expect this plan to work? And would all students
who choose the community college have no cost of going to that
college?
Secretary Cardona. Thank you, Senator. I recognize that
there are many States that are doing amazing work providing
access to higher education institutions. I was in Michigan
recently, and I saw amazing efforts there to make college
affordable and accessible to students in Michigan. But this
plan would allow 5.5 million students to have access to higher
education who might not have had it previously.
And we know that not only is it a benefit for these
students, but it is a benefit for their families, their
community, and there is an economic benefit. Graduates of 2-
year colleges, on average, earn 21 percent more than students
with a high school diploma. We know that the skills that are
needed in the workforce today are skills that would require
some level of training.
So with good coordination, our free community colleges
connecting with our high schools, connecting with the workforce
and 4-year colleges, which stand to gain because there is going
to be a wider net of students seeking higher education. We do
feel that this is a step forward for the country.
Senator Blunt. Good. I don't disagree with any of those
thoughts, except your point that there would be, I think you
said 5 million students that would not have access to community
college, otherwise. What about all the students that could go
to community college, otherwise, that we are--are we now paying
that tuition as well?
Secretary Cardona. Many of those students are benefiting
from supports now. What we are doing is leveling.
Senator Blunt. No, no. That is not what I am asking. What I
am asking is if any student at any income level wants to go to
community college, can they go for free under this program?
Secretary Cardona. Yes, it would be accessible to all who
want to study in a community college.
EXPANDING FREE COLLEGE PROPOSAL TO ALL ACCREDITED INSTITUTIONS
Senator Blunt. So why would--so let's go to a second
question. Why would you focus that first 2 years on a community
college when students might want--that even qualify for, for
instance, the Pell Grant now, they can take that Pell Grant
money and go to any college, any accredited institution, public
or private, they want to, and many of those institutions now
with fully qualified Pell students, figure out how there is no
other costs beyond Pell. Why would you not allow them to
continue to have that same ability to go free to those schools
as well, if they are students in real economic need?
Secretary Cardona. Under this proposal, students will still
have the choice to attend the college that they would like,
benefiting from Pell Group programs if they are eligible. So it
does not limit options. If anything it provides more options,
and provides more opportunity for students who might not have
considered higher education an option for them due to the
costs.
Senator Blunt. What about, generally, to continue this
discussion, we should have free first 2 years of college, or
free college for everybody, but that almost always talks about
a college in a public school setting, as opposed to an
accredited school setting. I think one of the real strengths of
the American higher education system since World War II has
been virtually all of our programs, whether they were the GI
benefit, or Pell Grants, or any other Federal Government
program, you had the ability to use that at any accredited,
post-secondary institution.
What is your view on that? As we continue to discuss how
access to various levels of grants and fundings public--versus
both public and private competing with each other after high
school?
Secretary Cardona. Thank you, Senator. You know, I look
forward to continuing conversations with you and others to find
the right pathway. What we want to do is provide access to
higher education for students across the country; we know that
access to higher education affords students the opportunities
to better options in life, higher earning potential. And that
is good, not only for the student, but for the community and
the economy, as I said earlier. So I am a big proponent of
providing options for students who want to pursue different
careers, or different educational institution based on their
choice. And I would be in support of exploring options to make
sure that that is accessible under this plan.
Senator Blunt. Well, the current system, as you know,
creates lots of options to accredited institutions. I hope that
continues to be the case, and certainly something you and I
will continue to talk about. Thank you, Secretary.
Secretary Cardona. Thank you.
Senator Blunt. Thank you, Chair.
Senator Murray. Senator Shaheen.
Senator Shaheen. Thank you, Madam Chairwoman.
ACCESS TO AND USE OF COVID RELIEF FUNDS
Mr. Secretary, we are delighted to have you here today. I
want to start with a challenge that we are having in New
Hampshire. As you know, Congress has provided nearly $200
billion for emergency relief for elementary and secondary
schools as a result of the COVID pandemic. This funding was
intended to assist schools during this emergency, and Congress
was very clear when we passed that legislation, that the intent
of these funds is to be--allow them to be at the school's
discretion to meet a wide variety of local needs, including for
construction projects, such as HVAC (Heating, Ventilation, and
Air Conditioning) repairs and improvements.
I am very concerned about the delays that many New
Hampshire schools have experienced when trying to access this
relief funding. And I have been troubled by the Department's
delay in issuing clear implementation guidance that regards
regulatory requirements on States and school districts. Now I
appreciate the guidance that was just provided to--by the
Department to New Hampshire yesterday.
I hope it resolves some of this uncertainty, but there are
still questions that schools have, and in order for them to
benefit from this money, we have a limited time for
construction during the summer, and so it would be really
important to have the Department be very clear on the use of
these funds. So can you talk a little bit about how the
Department is working to allow expeditious access to the funds
that have been approved and appropriated by Congress?
Secretary Cardona. Thank you, Senator. You are absolutely
right. The importance of being expedient in the use of funds to
get them into the schools, to provide the resources that are
needed, to get the students what they need to be in the
classroom quickly and as safely as possible. And with the
distribution of funds, we recognize that different parts of the
country have different needs. I was in Philadelphia recently,
and I learned how the ventilation issues in those schools
prevented students from coming in at the same rate as
communities that had schools that were a bit newer and had
better ventilation. So in that particular area, the issue was
ventilation.
So what we want to do is balance flexibility around how the
funds are used with ensuring that the funds are being used to
safely reopen schools, and address inequities that were
exacerbated during the pandemic. And by the strategies that we
are taking is becoming accessible, and making sure we are
working with States on their individual needs, and their
individual challenges. We worked closely with various States,
meeting with them and having conversations with not only their
educators, but their elected officials, to ensure that
maintenance of effort is being kept, and that the funds are
being moved quickly to help the schools, and getting out to the
LEAs (Local Education Agency) as soon as possible, and we will
continue to do that.
Senator Shaheen. Well, I appreciate that, but that hasn't
happened as expeditiously in New Hampshire, as the school
districts really need it to happen. The ventilation systems,
the HVAC systems are clearly an issue in many of our schools,
and again, when Congress passed these funds, we tried to make
it very clear that we wanted them to be as flexible as possible
for use by the schools. So as you point out, the more the
Department can be accommodating, and working with States on
their needs as quickly as possible, the better.
Secretary Cardona. Thank you, Senator.
Senator Shaheen. So do I have your commitment that the
Department will continue to work with the State of New
Hampshire?
Secretary Cardona. We will be on the phone with New
Hampshire today, Senator.
STUDENT LOAN REPAYMENT
Senator Shaheen. Thank you. All right. I am going to hold
you to that. You and Senator Murray talked a little bit about
the student loan program, and the effort to help address the
challenge that many students are facing. This moratorium is
scheduled to end September 30. I just wonder if the Department
considers the final date of the moratorium, are you looking at
a further extension? One of the challenges we have heard from
people is needing certainty, as they are thinking about going
back to school, and both loan agencies and students themselves.
Secretary Cardona. Yes. You know, we are aiming to provide
as much of an on-ramp for these borrowers as possible. And the
date in September payments are--we are starting in October is
something that we have, but we are continuing conversations
about if that is the best time. No announcements today, but we
continue to have those conversations. We recognize that for
many families the recovery of this pandemic will come around
the same time. Students are going to be returning to schools,
mortgages have to start getting paid, and loans have to start
getting paid. So we want to make sure we are sensitive to the
needs of the borrowers and aware of the other challenges that
they have.
We are going to continue to do as much as we can with our
authorities. Just today we are announcing $500 million in new
discharges for, over 18,000 borrowers who attended ITT
technical college just to make--technical institutes, excuse
me, just to make sure that every authority that we have
currently, we are taking advantage of it to support our
borrowers who are in need. And we do want to provide timely
information, as Senator Blunt also mentioned, and make sure we
have as long an on ramp for these borrowers to start repayment.
Senator Shaheen. Well, thank you. I appreciate that. And I
know that it is a huge concern for borrowers, but the sooner
decisions can be made, I think the better people can plan.
Secretary Cardona. Thank you.
Senator Shaheen. So thank you. Thank you, Madam Chair.
Senator Murray. Thank you.
Senator Moran.
Senator Moran. Thank you, Chairwoman.
INDIVIDUALS WITH DISABILITIES ACT
Mr. Secretary, thank you for your presence today. Let me
just highlight a couple of things that I am pleased with, and
that would be IDEA. The increased funding support for that is
valuable, commitments were made a long time ago, and those
commitments have not been kept for a long time. And a
significant component of our success in education will be our
ability to educate those who need the IDEA aspect of our public
education system.
IMPACT AID
And I look forward to working with you to see that we
continue to provide additional support for those students. I
also want to highlight the importance of Impact Aid; Kansas
with Fort Riley and Fort Leavenworth, they are hugely important
to assist our school districts that have a large presence of
public lands. And I look forward to working with you to see we
support Impact Aid and its ability to level the playing field
in the finance of education in my State.
TRIO
Let me ask a question about TRIO. The Biden Administration
proposed investing $62 billion in new college retention and
completion services. This, to me, seems unnecessary spending on
a duplicative program when we have TRIO programs. And I noticed
in your comments you bragged about the significance and value
of TRIO, but what is the circumstance that suggests that this
is not duplicative or that the resources that you are putting
into new programs could not be utilized in the TRIO programs to
achieve the same outcome?
Secretary Cardona. Thank you, Senator. And I do agree that
the investment in special education is so needed. I have spoken
to families of children with disabilities, in particular,
families with children with autism, who have said, ``you know,
the laptop alone is not going to cut it.'' So I am hopeful that
our students with disabilities are going to get the support
that they need, and that we are on a path to fully funding it.
With regard to the TRIO programs, you know, one thing we
have heard is, students who are in our community colleges or in
our 4-year colleges, due to the pandemic have had to leave. And
there is a lot of concern whether or not they are going to be
able to come back. And we also know that this translates into
high school students who were maybe once thinking about going
to college, not having that opportunity, or having to work now
to supplement the income of the home, and have other factors
that are pulling them in a different direction.
So the $200 million increase in the TRIO programs, to me,
addresses what we know to be the case. What we are hearing from
educators, what we are hearing from families, what we are
hearing from students is that going to college for some
students who might have been considering it, it seems a little
bit further removed. And we want to make sure we are addressing
that, so that we do continue to have students in colleges
across the country.
Senator Moran. Well, my concern is not that you are
increasing the TRIO program by $200 million; it is if TRIO is a
valuable program, which I believe it is, why would we create
new programs with new funding, the $62 billion, without further
utilizing the TRIO programs that already exist? We have a habit
I think in Congress, and I can't imagine that is--an
administration that is immune. We in politics and public policy
have a habit, when we try to highlight the value or the
importance we place on something, we create a new program.
And my suggestion is, my request is an understanding of why
current programs, such as TRIO, would not be the vehicle by
which you deliver new assistance. There are lots of schools in
Kansas and across the country that would love to have a TRIO
program, would love to expand the number of TRIO programs they
have. Those are restrained in many instances because of lack of
funding, and yet we are putting significant new dollars into a
new program, which I would suggest has a pretty similar
objective as TRIO.
Secretary Cardona. Thank you, Senator. Well, we want to
make sure we have opportunities for all students. And I agree
with you, the TRIO program is successful when it is able to get
students into college. And I hear your question. You are
saying, why are we duplicating services if TRIO does similar? I
look forward to working with you to discuss this further. And
we would be happy to have conversations about where you feel we
should be looking at things, and combining them instead of
setting a new programs.
Senator Moran. I look forward to working with you. And I
was particularly interested in your response to Senator Blunt's
question, which I--the answer at least to me, was incomplete.
And I would be welcoming to see why, that the ideas that
Senator Blunt suggested are ones that don't, in your view, have
merit. Thank you.
Secretary Cardona. Thank you.
Senator Murray. Senator Durbin.
Senator Durbin. Thanks Madam Chairman.
Mr. Secretary, thanks for being here.
Secretary Cardona. Glad to be here.
FOR-PROFIT COLLEGES
Senator Durbin. This is not a trick question, but do you
have any idea what percent of post-secondary students in
America enroll in for-profit colleges and universities?
Secretary Cardona. Off the top of my head, sir, I don't,
but I can get you that information.
Senator Durbin. I will tell you what it is. I will give you
the answer, and it is not to trick you. It is 8, 8 percent
post-secondary students in America enroll in for-profit
colleges and universities.
Next question, what percent of student loan defaults in
America are accounted for by for-profit college students?
Secretary Cardona. I have a feeling you are going to share
that answer with me, sir. So, I will, turn it back to you.
Senator Durbin. As I said, I am not trying to trick you,
30.
Secretary Cardona. Thirty.
Senator Durbin. Eight percent of the students, 30 percent
of the student loan defaults. What does it tell us? It tells us
they are enrolling students who cannot finish, won't finish. It
tells us also they are charging money that students cannot
repay even if they are employed, 8 percent, 30 percent. As
often as I meet you here each year, I am going to ask you the
same question, because the numbers don't change.
But here is what is interesting, in the COVID-19 situation,
colleges and universities across America are generally
struggling for enrollment, except for the for-profit schools.
They have seen a 3 percent increase in students. How can that
be? Are they that good? They market and advertise constantly.
You don't have to turn on television, or look into the news
except to see the latest ad for them. Now, the reason I raise
that is because I think that raises a serious policy question
about a branch of higher education that is failing so many
students and yet receives such a handsome Federal subsidy.
Now you have many roles, a Secretary of Education,
educator, principal, president of the university, all these
things, all of the above, and you certainly have the background
for it, but there is one aspect of your responsibility then I
want to delve into that is not often brought up. You are the
Nation's--one of the Nation's biggest bill collectors. You are
a credit agency, you are a banker. And I want to tell you the
record that was written by your predecessor in this field is
not one that I think we want to see continue. For example, if I
might. Public service loan forgiveness. Are you familiar with
it?
Secretary Cardona. Sure.
STUDENT LOANS
Senator Durbin. Do you know what the DeVos administration
did with public service loan forgiveness? I will tell you. 99
percent of those who applied were denied, that is just
outrageous. And then Congress tried to extend the program with
a new version. That was ignored as well. So Secretary DeVos was
channeling Henry Potter and not George Bailey many, many times.
When it came to borrower defense of 108,000 students who
applied, and said that they were the victims of fraud by for-
profit colleges and universities, the DeVos Education
Department, as they were leaving town, denied 80,000 of them
after waiting month after month, and year after year. The lives
of these borrowers have been compromised.
Now, I don't know how familiar you are with ECMC
(Educational Credit Management Corporation). Has your staff
given you a briefing on your collection agency?
Secretary Cardona. Yes. I have heard it.
Senator Durbin. They have?
Secretary Cardona. Yes.
Senator Durbin. Well, I will tell you, the last point I
want to make before I turn it over for your response is this.
They are outrageous. The policies that they use to collect on
student loans, I don't think any of us want to try to defend in
public. If someone goes into bankruptcy court and tries with
the one narrow exception to the bankruptcy code for student
loans, undue hardship, they don't have a chance. ECMC is going
to beat them back, whether or not you are dealing with
veterans, who are so disabled that they can't pay back their
loans, people subsisting on Social Security Disability, people
with terminal illness, they are all beaten back and denied by
your collection agency. So, open question: What would you like
to do about it?
Secretary Cardona. Thank you, Senator Durbin, for bringing
out the facts, on something, that I will be very frank with you
is the top priority at the agency. We have done a disservice
and it is time to act. It is time to have our students at the
center of the conversations there. It is a high priority for me
to make sure that we correct that, it is unacceptable to have a
98-99 percent refusal with public service loan forgiveness.
I had a conversation with students who had to go through
that process and were given the run around. I was frustrated
after that call. They had to hold on and go through different
hoops to try to get an answer. And then the answers were not
accurate, and they had to go somewhere else. So, there is a lot
of work that has to be done.
I recently hired Richard Cordray. He was recently appointed
by the President. And we need to have a consumer protection
mentality, we need to put the students at the center of the
conversation, and we need to make sure that what we are doing
at the agency, is a model for what we expect. And we have to
put our loan providers on notice that we are going to put the
students first.
We have not been sitting around waiting either though, we
have provided a $1.5 billion in relief through borrower
defense, by delivering a billion in full relief to 72,000
borrowers, and approving 500 million in discharges, as I
mentioned with ITT. So, we are taking every opportunity now to
change the culture there. And the message is very clear to
Richard. Fix this. Fix this, and move quickly, and be
transparent, and change the culture that people perceive.
As you pointed out, we have a culture to change and we have
better--we have to implement strategies better. Our students
cannot wait, and we are contributing to the problem, you will
see a turnaround in that. That is a priority for me.
Senator Durbin. Thank you. Channel George Bailey. Thank you
very much.
Senator Murray. Thank you.
I will turn to myself, and then Senator Blunt for a second
round. I would just notify all committee--members and staff to
please tell your members to be here, because if there is no one
else to present at after that time we will wrap up this
hearing. I know Mr. Secretary, you are sad to hear that.
Secretary Cardona. I know.
RATIONALE FOR ADDITIONAL FUNDING
Senator Murray. Mr. Secretary, the President's budget calls
for major new investments in our Nation's public, elementary,
and secondary schools, totaling $66 billion. That is an
increase of $25 billion more than last year's, LHHS (Labor,
Health and Human Services) bill, now Republican and Democrats
were able to work together on COVID relief in our regular
appropriations bills last year. The $125 billion in K-12
education investments included in the American Rescue Plan Act
passed earlier this year did not have bipartisan support. And
some of our Republican colleagues expressed concern that those
funds would not be spent quickly or were unnecessary.
Tell us why you think the additional K-12 investments
proposed in the President's budget are needed on top of the
significant COVID supplemental appropriations that are already
enacted into law?
Secretary Cardona. The technical support that the
allocations provide are critical, and I will get into that, but
let me first talk about how important it is that the President
signal a transformational change in how we view education as
the foundation of our country's growth.
As the First Lady said, any country that out-educates us
outperforms us. So, this administration understands the
important investment in education. And I don't have to remind
you, because you mentioned it in your opening comments, years
of underinvestment in education. I have seen that. I was a
principal when we were asked to do more with less. I had class
sizes that were very high, with teachers who were doing their
very best to meet the needs of students, and those needs kept
increasing, but the funds kept decreasing.
There is a realization here, that if we don't get this
right, so much else is going to suffer. So, when we talk about
what this investment can turn into, it can turn into smaller
class sizes. It can turn into better teacher preparation.
Students are coming back from a trauma-filled year. I spoke to
a student at Harvey Milk School 2 days ago, in New York, who
told me his grandmother and his significant other died in the
last year.
This student is going back to school. If we are not
investing in additional trauma support, training to make sure
everyone, including our school bus drivers, our cafeteria aides
who have been heroes this past year, have the support and
training to help meet the needs of these students when they
come in, then we don't stand a chance. If we are not providing
funds to give students access to digital devices and broadband
so that they can have access to learning wherever they are,
then we lost an opportunity.
The pandemic exacerbated the need. You mentioned it in your
opening comments, the impact that it is having on our poor
communities, in our rural communities students didn't have
access to broadband during the entire pandemic. We cannot
continue under-investing in education and think that we are
going to continue to produce students that are going to lead
the world. We have an opportunity here, an obligation, a
privilege to make sure we are funding our schools, and giving
our educators the tools that they need to be successful. More
importantly, giving our students the tools that they need to be
successful.
Imagine our country, when students don't have to worry
about not having a teacher in front of their classroom, enough
materials, or access to technology so that they could get
access to basic deliverables in education. That is where we are
going. And this bill does that. The American Family Plan boldly
communicates that. And I am excited about supporting it moving
forward.
SIMPLIFICATION OF FREE APPLICATION FOR FEDERAL STUDENT AID
Senator Murray. Thank you. I really appreciate that
response. Mr. Secretary, too many students miss out on college
financial aid that they are eligible for, like Pell Grants, in
part because the application process has been so cumbersome.
Last December we were able to finally reach a bipartisan
agreement to significantly simplify the Federal Student Aid
Application process with the passage of FAFSA Simplification
Act, and that law, by the way, also expands eligibility for
Federal financial aid.
The administration's budget request does include a
significant increase in funding to implement those and other
related changes. But unfortunately, the Department announced
last week, as you know, that some of those changes cannot be
implemented quite as fast as all of us had really hoped. This
is not a criticism of the Department. Everyone wants the law
implemented as quickly as possible, but tell us what the
Department is doing to implement FAFSA as quickly as possible,
including moving forward with key benefits for students on
time?
Secretary Cardona. Thank you. And I recognize it is not a
criticism, but, but we need to get moving on this. And I thank
you, and Senator Blunt, and others who have really pushed this,
and understand the importance of that simplification process. I
have talked to students who said, you know what, that is too
much. Or families, I can't do that. And they have missed out on
opportunity.
So, the simplification process is critically important, but
the reality is we walked into a system that doesn't have the
capacity. As I mentioned in the previous statement, you know,
under-investment leads to results. Well, we have a 45-year-old
computer system that can't handle the changes that are needed,
and that you voted for.
So, we need to move quickly, swiftly, to make sure we are
prioritizing that, that is critically important, the FAFSA
simplification. We are on it. We are going to prioritize that,
again, another area that Richard is really prioritizing. And we
are going to keep you updated. You deserve to be updated on
what progress we are making, what challenges we have, that is a
priority for the agency, and for me as Secretary.
Senator Murray. Thank you very much.
Senator Blunt.
TRANSPARENCY OF COVID RELIEF SPENDING
Senator Blunt. Thank you. Thank you, Chair. On the topic of
new money to schools, Congress provided in the American Rescue
Plan and the COVID supplementals, a total of $190 billion to K
through 12 education. Data provided to us by the Department as
of June 4, less than $9 billion of that has actually been spent
by schools. What can we do to ensure that that money gets
spent, and there is more transparency about how and where it is
being spent?
Secretary Cardona. Thank you for that question. And it
gives me an opportunity to share that as the commissioner of
education, during the beginning of the pandemic and throughout
most of the pandemic, we also had to develop systems that did
not exist before, to distribute money in this unprecedented
time, to make sure that LEAs had the support they needed. And
as the Senator mentioned earlier, in some places that process
is slower than we would like.
So we are in communication with our districts, our State
LEAs, and we recognize, however, and I can tell you from
experience that, you know, a good portion, sometimes 80 percent
of budget is human resources, right? So that money is drawn
down as the contract, or the year goes by. And we recognize
also that this is a 3- to 4-year process where the funds are
going to be used to provide services for multiple years. Also,
contracts that are signed off on are not paid for until the
services are provided. And in many cases that extends years.
So, we recognize the need. I think the transparency, what
you brought up is critically important. We asked that any
planning that is being done for funds with the American Rescue
Plan have transparency that are posted on websites and that
engage stakeholders, so that folks know how the money is being
used. We have a responsibility to ensure every dollar of
taxpayer money is being used to support what it was intended to
use.
Senator Blunt. Right. Now I certainly agree with that. And
I think we actually assumed that more of that money would be
spent on technical support and things that wouldn't have been
part of the normal education system that districts had in
place, as opposed to long-term contracts with individuals, and
things that probably were in their normal and regular budget.
IN-PERSON INSTRUCTION
I hope we are looking carefully to see that that money is
spent, to be more ready for virtual education when we need it,
and different kinds of communication when we need it.
Obviously, as Senator Murray has pointed out, and others have,
the loss of learning in many cases to people who couldn't go to
school, either they didn't engage in a virtual class, or that
wasn't the right way for them to learn. Where do you think we
are going to be in the fall in terms of in-person learning?
What percentage of American public school students do you think
we will be back in school in the fall in person?
Secretary Cardona. Some of the expenditures that take time,
as you mentioned, are critical, virtual learning access,
broadband access, and that does take some time. With that said,
I do expect 100 percent of the students across the country to
have access to in-person learning. April data shows that 96
percent of the K-8 students had an opportunity to learn in
person. But I would argue that hybrid isn't a great option.
In many cases families can't do the hybrid option because
parents have to work. It is all or nothing. I am pushing really
hard to make sure that we are addressing, and we are working
with States, and local LEAs to address whatever factors might
be preventing them from offering full in-person learning, full-
time for all students in the fall.
That is my expectation. And we are having conversations
regularly with different State leaders, and local education
leaders to make sure that that is--the message is clear, and
that the expectation is there. The funds are there. We have to
make it happen for our students, Senator.
STUDENT LOAN SERVICING
Senator Blunt. Let's talk about loan servicing for just a
minute. Certainly, as you pointed out, and I was pleased to be
in involved in trying to simplify those loan forms. Senator
Murray and Senator Alexander and the Authorizing Committee,
last year, did a great job of leading there. Now there has been
a discussion with the Title IV additional servicers, how we
connect better with students--with individuals who have student
loans.
This committee was not supportive of the last plan for the
next generation of student loans. We are about to run out of
the current framework of contracts. I think the current not-
for-profit servicers contracts, and between December of this
year and March of next year, there appears to be no plan to
replace the current system. What I am asking is: Will you use
the authority you have in the fiscal year 2021 labor bill to
extend these legacy of servicing contracts while you work on a
long-term servicing solution? Or do you expect to have a long-
term service solution in place by December of this year?
Secretary Cardona. We are working aggressively to make sure
we have a system that has very high standards for loan
servicers. We have to put the students at the center, while I
don't have an announcement to make today, I will tell you that
we plan on having an update, and we will update you within the
next month or so to share what the plans are with that.
Senator Blunt. Well, I will tell you. I have been very
involved in this discussion. I would like to be updated, and
would hope to be updated before you absolutely have a plan you
are ready to announce. And then if, for whatever reason, that
plan can't be put in place by the time these servicing and
agreements run out I hope you are thinking about the authority
that we gave you to extend those agreements if that was the
best thing to do.
Thank you, Chair.
Secretary Cardona. Thank you, Senator. We will be in touch.
Senator Murray. Thank you.
Senator Braun.
Senator Braun. Thank you, Madam Chair. I remember in our
first or second conversations along the way, we have had a--
kind of a spirited discussion on resources that we put beyond
education, in general. And in my opinion education, along with
one's healthcare, we ought to be doing that as well as
possible, not only through public, but through the private
arena as well.
RETURN ON INVESTMENT IN POST-SECONDARY EDUCATION
And post-secondary education now has the dubious
distinction of being the place where costs are going up more
per year than any other significant sector of our economy. Just
eclipsed a few years ago, the rate of increase in healthcare,
which is a place I have, since I have been here wanted to
reform and try to fix, because I think it is a broken system
there in terms of what we do through the private sector, and
through government, because we have got the entity itself, the
system that doesn't deliver, it has cost us in healthcare twice
as much as what it does in other countries.
So, I think it is silly to pour more resources in anything
that is not delivering outcomes that look like they are at
least headed in the right direction. So do you think when it
comes to the results, and let us look at post-secondary
education, I will come back to secondary in a moment. Do you
think we have been getting a good bang for our buck?
Secretary Cardona. There is always room for improvement,
Senator. And I can assure you that the team that we are
assembling recognizes the importance, and the moment that we
have to make sure we are improving access and affordability.
Again, I mentioned earlier, the American Families Plan provides
opportunities for students to access community colleges for
free. We know how important that is to give them an opportunity
to join the workforce with skills that they need to be
successful. And that the earning potential of graduates of
community colleges can be up to 21 percent higher.
We have work to do and we are going to be aggressive to
make sure that students are getting a good return on investment
in post-secondary education. And we are addressing the issues
that exist, where students are being taken advantage of, or
sold a bill of goods and never delivered on. We are on that.
And that is a priority for me.
Senator Braun. So my observation before I got here is that
you generally don't pour resources into something until you
look at what you have got, that you are trying to rebuild, re-
energize, or make better. And 41 percent increase over fiscal
2021 levels is embedded in this budget proposal. And my
observation, from being on a school Board for 10 years, to
wrestling with education at the State level as a State
legislator, it is not about spending more money, it is really
more about finding how we change the system.
To me it is analogous to healthcare. And as long as we are
here, since we live with no constraints, now added in the two-
and-a-half years I have been here, nearly $10 trillion in
national debt. The need to be a little more entrepreneurial, a
little more concerned about changing the paradigm. And here I
see most of this just pouring more resources into something
that doesn't need to tell us any more clearly, that it is not
delivering the goods.
SECONDARY EDUCATION ALIGNMENT WITH JOB MARKET
Before I run out of time, let me pivot back to, the same
point would be made in secondary education, before you get to
college. College is runaway with costs that even parents are
really scratching their heads. Is it worth it to send my kid
into a system that 50 percent of the kids that go there don't
pursue it, and many get a misguided degree, and employers don't
have a market for?
Why don't we try to get it better at the secondary level
and match training and skills with the high-demand, high-wage
jobs that all of us have out there? My State of Indiana,
checked with my kids, I think we have got 70 to 80 job openings
in our own company, out of a total employment of 1200. We don't
need any more 4-year degrees, because the jobs that we have in
a State like Indiana, where we ship out twice as many 4-year
degrees as we use in the State, we need better skills that are
being delivered out of high school.
I look at a place like Garrett High School, west of Fort
Wayne that catches kids and, obviously, parents, when they are
fifth graders, before they go to middle school. That is
something that would cost no more money, but would change the
dynamic of where we need to change our emphasis in how we do
things. And until education does that, until healthcare does
that, I really think we are just going to be borrowing more
money and putting it down a dubious hole. I won't refer to the
word that comes to mind. So, a quick comment on that.
Secretary Cardona. Thank you. I agree with you. If we do
what we have done, we are going to get what we have gotten. So,
you know, the plans discussed CTE (Career and Technical
Education) changes. We really, if you recall, my hearing, one
of my goals as Secretary of Education is to make sure we evolve
our secondary schools to meet the demands of the workforce, and
the careers that are available today, as you mentioned, in your
own community.
So, this is something that I am eager to work with. Not
only in the budget do we see that in there. And it is not just
resources, it is the change in mindset. We are going to get
there. And I look forward to working with you on that. I know
the Jobs Plan has funds for that, the Families Plan. I know the
President gets it, it is in the budget, and we are going to
make it happen. And I look forward to working with you on that.
Senator Braun. Thank you. And I would invite you to take a
road trip to Indiana and visit some of the places that are
setting the trend on what we, as employers, need which is a
better elementary and especially secondary education, before
you start pushing kids into a broken system after that. Thank
you.
Secretary Cardona. Look forward to working with you on
that.
Senator Murray. Senator Reed.
Senator Reed. Thank you very much, madam Chairwoman.
SCHOOL INFRASTRUCTURE
Welcome, Mr. Secretary. Your experience as a State
Commissioner of Education is, I think, invaluable because you
have seen these issues up close and personal, as they used to
say on television. And one of the issues I hope is not
debatable is the poor status of school infrastructure, and this
is not just an urban issue, it is a national issue.
I have been working very hard to get resources in for
infrastructure repairs in schools, and also in the context of
infrastructure repairs, you can do a lot of things like, change
the heating system to be more efficient. We discovered in the
pandemic, in Providence they had to teach all winter with the
windows open, because the HVAC system, and you probably had the
same situation in Connecticut, the HVAC system would not
support a safe instruction, and was probably built in 1930, et
cetera.
I am pushing very hard to get $100 billion in the Jobs Plan
for the schools. And I hope you can assist me in doing that,
with the President and with my colleagues.
Secretary Cardona. Thank you, Senator. Part of the ``Help
Is Here Tour'' we visited about nine or ten different States,
and visited about ten different schools. And as I mentioned in
an earlier response, the needs in different communities, post-
pandemic, were different. And one really stood out to me. I was
in Philadelphia, and I visited schools that were over 120 years
old. You know, where the windows are shut with paint.
Senator Reed. Lead paint?
Secretary Cardona. Yes. The students, they need better. And
it really just brought to the surface what educators have known
for years; that facilities do matter, but what is the first
thing that goes in local budgets when there is not enough
funds, the facilities' maintenance. I remember as commissioner
of education, talking to district leaders who said, our system
hasn't been touched in years, the maintenance of the system
hasn't been touched in years, the filters haven't been changed
out.
I learned more about MERV 13, MERV 15, more than I ever
thought I needed to know. But the point is there has been
negligence on facilities for years. And what we are finding is,
in order to get students back into school safely and ensure a
safe learning environment where the community could feel
confidence in their schools. When we talk about reopening
schools, we have to take that into account. So, I agree with
you. Part of the Jobs Plan has the upgrade and building new
public schools where it is needed, the $50 billion over 5
years.
But the community colleges also need the support, and the
$12 billion over 5 years there, is a commitment to making sure
that our facilities are safe places for our learners, for our
educators. So that kids go to school, they attend regularly,
and they have a learning environment where they can grow. So, I
agree with you there, wholeheartedly, Senator.
Senator Reed. Well, thank you. And I must confess part of
my passion is the fact that my father was a school custodian.
And so he would get to--in fact supervisor custodian--so he
would get those calls in the middle of a winter night to go fix
the boiler that was installed in 1927 or something like that.
Secretary Cardona. Exactly.
LITERACY
Senator Reed. A further question. I had an interesting
discussion with adult education providers, and they reported
that 95 percent of the students that they are serving, come to
them with virtually no literacy skills. They can't read, they
might graduate from high school, or at least going the length
of time they have to, but they can't read. And if they can't
read, it is very difficult to train someone for a job,
particularly in the sophisticated, post-industrial economy.
Secretary Cardona. Right.
Senator Reed. One issue I think is if making sure we know
what at least the rates are. And I have just wondered, do you
have national, local, and States' reliable statistics about
literacy?
Secretary Cardona. We do, we have data that we are tracking
in terms of where the States are. But we have to do more. We
have to do more to make them transparent, and to ensure that
the funds that are being used through the American Rescue Plan
are aimed at addressing those literacy gaps. I will tell you;
we know in education that if a student is not reading by 3rd
grade, you are going to be intervening for the rest of that
student's school career.
And in the process, probably disengaging that student in
ways where they can't take the courses that they want to
select, or think about college as early as they need to, to
make sure they have the same opportunities as other students.
But that is where I also believe, sir, that the American Family
Plan and the commitment on early childhood education.
Three- four-year-old programs, I saw as a principal, when
5-year-olds walked into the kindergarten classroom on day one,
we knew which students had access to high quality programs. We
could tell which students didn't, and we knew, day one,
kindergarten, which students were going to need intervention
and support. So you pay now or pay later, we really need to
focus on early childhood education, and literacy skills early,
science-based, research-based practices, to make sure that we
are allowing our students to have the best opportunity in life
by reading by 3rd grade.
Senator Reed. I agree, but we also have to pay attention to
adults who will miss these prospective reforms but still have
low literacy skills.
Secretary Cardona. Right.
Senator Reed. Thank you. My time has expired.
Secretary Cardona. Thank you. Thank you, sir.
Senator Murray. Senator Hyde-Smith.
Senator Hyde-Smith. Thank you, Madam Chairman. And thank
you, Mr. Secretary, for being here. I absolutely loved the
background that you have, and it is very obvious that you
really get it.
Secretary Cardona. Thank you.
Senator Hyde-Smith. And I appreciate that, because I can
tell by your passion that you know exactly what these students
are going through. So that I truly want you to know how much I
appreciate that.
Secretary Cardona. Thank you.
FLEXIBILITY IN USE OF COVID FUNDING
Senator Hyde-Smith. As we know from COVID, so many kids got
just really far behind in so many areas, and great concern, not
just in Mississippi, but everywhere. But Mississippi has
recently received significant American Rescue Plan funding to
help reopen our schools. The reality is that most Mississippi
schools have been open for in-person learning for nearly 10
months, as many Mississippi schools resumed classroom
instructions last August. We really got back in quick with good
results, and made some good decisions there that our leaders
made. But the school year for most Mississippi schools ended in
early May, and students are already out for their summer break.
In your submitted testimony you stated that the plans to
reopen are bold, and will require coordination among key
stakeholders at the Federal, State, and local levels. However,
this statement, and several others from the Department, seem to
ignore the fact that many other States, like Mississippi, have
been opened since fall of 2020. So, we have this money, but we
have already been open, but how much flexibility are schools
being given to use the American Rescue Plan funding? Because
that is the calls that I get, and that is the questions that I
get, from my schools and my educators.
Secretary Cardona. Yes. Thank you, for first of all, for
your comments, and for the thoughts that you are bringing up on
behalf of the constituents you serve. And like you, my own
children have attended since August, and I have been fortunate
that some of the students in Mississippi that were able to
attend in person, early, safely. That is critical.
So, we know, as I mentioned in a previous response that the
impact of COVID effected some regions differently than other
regions. And we have to be aware of that and provide the
flexibilities where needed. We recognize that in some places,
while students have been in school, it might have been in a
hybrid model, or some students have had access more than other
students, due to, whether it is confidence, or trauma with the
pandemic, some students will still need support even if they
are going into school, maybe half-time, or full-time even.
We also know that summer learning will help bridge those
gaps of learning that we experienced through the disruption of
COVID-19. So, flexibility is important. And what we are trying
to do is balance flexibility while making sure that the impacts
of COVID-19 are being addressed with the American Rescue Plan,
as was the expectation from Congress.
So, we are working closely with States to communicate
flexibilities, and we are available, if there are questions in
Mississippi, to discuss how their plans are being rolled out,
and questions that they might have around flexibilities, or
adherences to specific requirements that might have come out of
the agency.
Senator Hyde-Smith. So, all we have to do is really contact
your Department and for these individual questions, because I
know they have some really good ideas, but we want to make sure
we are following the guidelines the way that we are supposed to
be doing that.
Secretary Cardona. Sure. Senator, you know, we do encourage
innovation also. So, we look forward to hearing it. As matter
of fact, we will reach out, just to make sure that we are
partnering with Mississippi to make sure that their questions
are answered, and that we can promote as much flexibility to
meet the needs of the students as needed.
CHARTER SCHOOLS
Senator Hyde-Smith. Thank you. And I have a little time
left. We have seven charter schools operating in Mississippi
and, you know, charter schools have given parents the
flexibility to decide which schools best fits their child's
needs, individually, and not the government. In some instances,
charter schools also have the freedom to adapt their classrooms
as they see fit. And over the years, charter schools have seen
increases in academic gains. We have had a lot of success
there, which allow children more opportunities as they continue
in their academic career.
And with your commitment to ensuring all students have
access to a quality education, how will you support school
choice in order to expand access to higher quality charter
schools?
Secretary Cardona. I am a big proponent of high-quality
schools for all students across the country. And I recognize
that students have options and, public charter schools are
options for students. And I feel that all schools should be
held to similar standards of accountability. And I think that
is where I stand with that. I have seen examples of schools
that needed a lot of intervention, but I have also seen
examples of schools that really met the needs of the student
and the families in a charter school.
Senator Hyde-Smith. Because we really had some good luck.
We had a Senator Michael Watson, State Senator at the time,
really worked on this a long time. He is Secretary of State
right now. But it really proved that we made a lot of ground
there that were good decisions and beneficial. So, you will
continue to support funding for the charter school program? Is
that what you are saying?
Secretary Cardona. Yes. The President made it very clear.
You know, we don't--we are not going to be promoting a private
charter school growth, but we are endorsing the programs that
exist now where students are taking advantage of public charter
schools.
Senator Hyde-Smith. Great. Thank you very much.
Thank you, Madam Chairwoman.
Senator Murray. Thank you. My understanding is Senator
Manchin is going to walk in the door behind me at any moment.
He will be our last questioner.
STATE PLANS FOR ESSER FUNDING
While we are waiting for him. Mr. Secretary, I just wanted
to thank you and your staff for all the hard work implementing
the American Rescue Plan Act and other COVID-19 Relief
Legislation, and the fiscal year 2021 Appropriations Bill. I
know you got a lot on your plate. And I know the processes--the
Department is really in the process of reviewing the State
plans that are being submitted for each State's final one-third
share of ESSER (Elementary and Secondary School Emergency
Relief Fund) allocations under the American Rescue Plan.
But one of my priorities really is, is that the
legislation--in the legislation is the required State and
school district set asides for evidence-based interventions
that address the academic, and social, and emotional needs of
students of color, students experiencing homelessness,
underserved students.
Secretary Cardona. Yes, right.
Senator Murray. And I really appreciate the Department's
template for State plans that include descriptions of state
strategies, for carrying out these required activities, and
strategies for States to support these district plans. Can you
just assure us that the Department will only approve high-
quality plans that effectively address the requirements of the
law?
Secretary Cardona. Yes. As I said at the beginning, that is
where the honor lies, making sure that we are serving our
students. And on behalf of the 50 million students, when we
review those plans, we want to ensure that we are building back
better, and that the plans are addressing the inequities that
were exacerbated by the pandemic, that the plans engage our
stakeholders in different ways, because that is critically
important. Many folks who were already struggling in school
prior to the pandemic are now further away. So, we need to
engage them to make sure that the schools that we are reopening
are welcoming places that are able to meet their needs as well.
Senator Murray. Well, thank you. I really appreciate that
commitment. And I just ask that you keep my staff updated on
the review of those plans. As you know, high quality plans are
only successful if they are effectively implemented. And I know
your Department has hosted webinars, and established a
clearinghouse, and taken some other actions, which I really
appreciate.
And while we are waiting for Senator Manchin, share some
thoughts on how the Department will support and monitor those
plans.
Secretary Cardona. Senator, I appreciate you mentioning the
actions that we have taken. We have--take your time. This is
something I want to talk about. So, we do have a best practices
clearinghouse, innovation doesn't come from Washington, D.C.,
alone. In fact, across the country, we have over 1,100
submissions of innovative practices to reopen schools, and
engage those students that were hardest to engage during the
pandemic.
So, we are lifting our best practices from across the
country. And, you know, I always say, we are going to heal
together, we are going to learn together, we are going to grow
together. And the tools that we have are at the disposal of the
districts now are tools that were developed with them, not for
them, with them. And I have to say that, you know, we are
continuing that conversation. We are having an equity summit
next week, where we are inviting everyone to come take a look
at what it means to rethink addressing inequities, and be bold.
Our students deserve it. Looking forward to that.
Senator Murray. Thank you. Thank you.
Senator Manchin.
Secretary Cardona. Senator.
Senator Manchin. Did I interrupt you?
Secretary Cardona. No. Not at all.
HOMELESS EDUCATION
Senator Manchin. Thank you so much. Let me, a few things.
And I appreciate so much, Secretary, on the difficult job you
have. And I want to go through a few things because a lot of it
either makes sense or doesn't make sense. But the main thing
is, I have really a problem with homelessness with children.
And I noticed that the budget hadn't been increased for that.
But I know that we put, myself and Murkowski, and all of our
colleagues on both sides of the aisle supported $800 million
going into that. But if the base doesn't move because, if it
hasn't moved, it has been flat.
Secretary Cardona. Right, right.
Senator Manchin. It is growing. I hope you would show
attention to that. I know we were able to meet it this year,
but we won't be able to meet a year after that.
Secretary Cardona. Right.
Senator Manchin. Okay? So, if you can.
Secretary Cardona. Sure. And I appreciate that. I recall
experiences with students in the district where I worked
before, who were experiencing homelessness. And I was always
amazed at how they were able to engage in learning, and be a
part of extracurriculars with housing instability, not knowing
where they were going to go.
And that reduces the bandwidth for learning when you are
thinking about where am I going to sleep tonight? So, the
money, the $800 million for homeless education through ARP
(American Rescue Plan) is critically important. But I also want
to share that the focus on community schools--the focus on
community schools, and the vast proposal in the American
Families Plan, is also intended to address some of these issues
that lead to homelessness, right?
Senator Manchin. And I think homelessness, and I was just
asking, we need to describe it make sure we are all on the same
page.
Secretary Cardona. Right.
Senator Manchin. McKinney-Vento describes homelessness one
way, and the Department describes it another way. So, they
might show in West Virginia we don't have that many. We know we
have because we are basically talking to the schools. We know
kids have been disrupted, things like that.
Secretary Cardona. Right.
Senator Manchin. We need to get that definition on the same
wavelength. And let me go through a few more.
Secretary Cardona. Sure.
Senator Manchin. So, on that one there, and the second
tranche of money is going to supposed to come out for them, the
McKinney-Vento. These are very, very important. The other thing
I wanted to talk about is community college. Okay. First of
all, I will talk about pre-K 3 and 4, which I agree one million
percent.
Secretary Cardona. Yes.
Senator Manchin. We have been doing it when it wasn't even
popular.
Secretary Cardona. Right.
Senator Manchin. Let me tell you why we did it. Just on
nutrition, just giving kids some stability in life. And we had
a challenge in Appalachia. So, we had to. And I did it when I
was governor, we have done it, and it has worked out great. So,
I am glad the whole Nation, because you cannot get ahead of the
curve if you don't start at 3 and 4 years of age.
Secretary Cardona. Right.
FREE COMMUNITY COLLEGE PROGRAM
Senator Manchin. God bless you on that. Where I disagree a
little bit on community and technical colleges, and I disagree
on free.
Secretary Cardona. Mm-hmm.
Senator Manchin. And I said, let me earn it. I have told
people this and, you know, someone said free college. I said, I
have a child, who is up 30-40 years of age. If they had had
free college, they would still be in college. They never left,
they loved it so much. That is just a little tidbit on that.
But on community, here is the thing. Community technical
colleges usually trained to skills, skill sets. It is not the
same as a 4-year baccalaureate, or it gives them a segue,
because their grades might not have been good enough. Okay. I
understand all that. But most of it is skill sets.
If we could determine the skill sets we need in different
categories, in different parts of our country. So, if our
community colleges are training for one thing in West Virginia,
you are training for another thing in California, another thing
in different parts of the country. If those skill sets are met
by someone who is going, and we have a Stafford loan that we
basically guarantee federally, you take the loan out. You, you
accomplish that within a 2-year period of a community college,
and you have that associate degree, then it should be forgiven.
Let them earn it. Don't give it on the front end, earn it
on the back end. You be surprised how much more they respect
and appreciate something they have earned, than something you
have given them. That is the only thing I have said about that,
because I can tell you, as a parent, it works and works very
well. And it is very efficient. You know, that would be like
the same as a kid getting it: Where is my allowance, dad? And
he is 35 years old. Do you understand where I am coming from?
Secretary Cardona. Yes. Thank you, Senator. And I look
forward to hearing more, and working with you, too. We need to
make sure that all students have access.
Senator Manchin. Right.
Secretary Cardona. We need to make sure that all students
have either access to the skilled development that you
mentioned. And you are absolutely right, the workforce needs--
--
Senator Manchin. And for a time, either way.
Secretary Cardona. But also, it might be an opportunity for
students who don't think that they have the potential to go to
college, to get access to a 2-year college and then continue on
to a 4-year school.
Senator Manchin. No problem.
Secretary Cardona. So, we are widening the net, and we know
the earning potential is greater when you graduate college. And
I can tell you, 21 percent for community college graduates, I
believe this is good for the economy in the long term. It is
really creating a workforce with higher earning potential,
better discretionary income, and I do think it is----
FINANCIAL LITERACY
Senator Manchin. What is the dropout rate? You ever look at
the dropout rate? Do you know why student loans are so high?
Because we cannot even demand that they have financial
literacy. They come in, we cannot even have a registrar say,
no, you are not getting that much, Miguel, you don't, you only
need $4,000. I know you qualify because your family is for
$11,004, but $4,000 is going to be fine. They cannot say that.
So, end up stacking up debt, 2 years they flunk out or they
quit because they haven't had to pay any payments out. And all
of a sudden it comes tumbling down.
Secretary Cardona. Yes.
Senator Manchin. We do a horrible job of managing student
debt, but we are talking about, eliminated before you have
people responsible for it.
Secretary Cardona. We are going to be aggressive on the
student debt, and making sure that we are communicating, that
we are advocating for students, working with students, putting
the students at the center. I am eager to get going on that and
get started.
Senator Manchin. I cannot wait to work--I cannot wait to
work with you.
Secretary Cardona. Same here.
Senator Manchin. There are so many good things--and I would
love to----
Secretary Cardona. Same here. Thank you, Senator.
Senator Murray. Thank you.
Senator Manchin. Thank you.
Senator Murray. That will end our hearing today. I want to
thank all of our fellow committee members for their
participation. Secretary Cardona, thank you for your very
thoughtful answers today, and to talk about the President's
budget. I do look forward to continuing to work with you, to
support students and families in our country.
ADDITIONAL COMMITTEE QUESTIONS
For any senators who wish to ask additional questions,
questions for the record will be due Friday, June 25, at 5 p.m.
The hearing record will also remain open until then for any
member who wishes to submit additional materials for the
record.
Secretary Cardona. Thank you.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted to Hon. Miguel Cardona
Questions Submitted by Senator Patty Murray
Question. I'd like to follow-up on our discussion during the
hearing about implementation of fiscal equity requirements under
current law. These requirements include resource allocation reviews by
states, school districts and schools identified for support and
improvement. Earlier this year, the Government Accountability Office
(GAO) reported most states (43 of 51) indicated helping districts
identify resource inequities as somewhat or very challenging based on
survey results prior to the pandemic.
Please share the Department's plans in fiscal year 2021 and fiscal
year 2022 for supporting, enhancing and monitoring resource allocation
reviews by state and local education agencies and schools?
Answer. Section 1111(d)(3)(A)(ii) of the Elementary and Secondary
Education Act of 1965 (ESEA) requires a State educational agency (SEA)
to periodically review resource allocation to support school
improvement in each local educational agency (LEA) in the State serving
a significant number of schools identified for support and improvement.
This requirement is part of the Department's monitoring protocol for
Title I, Part A (available at: https://oese.ed.gov/files/2020/08/SEA-
Protocol-Title-I.docx, under ``Support for LEA and School
Improvement''). Specifically, the protocol asks each SEA to describe
how it periodically reviews resource allocation to support school
improvement in each LEA serving a significant number or percentage of
schools identified for comprehensive or targeted support and
improvement.
In addition, the Department has been providing on-going technical
assistance to States regarding this requirement. For example, the State
Support Network, created by the Department in 2016 to provide technical
assistance to support the transition to the Every Student Succeeds Act
(ESSA), hosted a community of practice (CoP) with 13 States in 2019
that focused on planning for school resource allocation reviews. Please
find more information and several resources here: https://oese.ed.gov/
resources/oese-technical-assistance-centers/state-support-network/
resources/resource-allocation-reviews-community-practice-summary/. The
State Support Network also created a number of tools to assist with
school improvement planning, including Tools for School Improvement
Planning, a CoP for ``Implementing Needs Assessments'' and other
resources for developing needs assessments. It also published several
blogs about using school financial data in decisionmaking, including
``Going Beyond Finances in Resource Allocation Decisions''.
Further, the Department's Comprehensive Centers have provided
individualized technical assistance to several States on this topic. In
the past 2 years (since the 2019 competition established new TA
providers), the Comprehensive Centers have been supporting States in
their implementation of ESEA requirements. Two centers specifically
have provided assistance to States on resource allocation reviews. The
Region 15 Comprehensive Center is supporting Utah in the State's work.
WestEd and the Region 15 Comprehensive Center have worked on an equity
driven resource allocation framework during another State collaborative
session. The Region 13 Comprehensive Center has worked with the
Oklahoma State Department of Education to design a Resource Allocation
Review toolkit. The Region 2 Comprehensive Center is supporting efforts
in Connecticut and Rhode Island to develop a process to conduct
resource allocation reviews.
The fiscal year 2022 request would build on these efforts to
strengthen fisal equity through the Title I Equity Grants proposal,
which would require each State to collect and make publicly available
detailed data on the allocation of State and local education funding to
school districts and schools. The proposal also would require the use
of a consistent definition of per-pupil expenditures to support
identification and mitigation of disparities in funding for high-
poverty districts and schools, along with goals, interim targets, and
timelines for closing identified gaps.
In addition, our proposal would encourage States to undertake a
comprehensive review of their school finance systems through a $50
million reservation for voluntary State School Funding Equity
Commissions that would (1) identify funding and educational opportunity
gaps based on measures of equity and adequacy; (2) through extensive
community engagement, develop detailed action plans for addressing
existing gaps that include goals, interim targets, and timelines for
closing identified gaps; and (3) report on progress toward these goals
and targets.
Question. The Every Student Succeeds Act (ESSA) established a
policy requiring the reporting of actual personnel and nonpersonnel
expenditures, disaggregated by Federal, state and local source of funds
for each school and school district in each State. Transparently
providing this information would allow a range of uses from parents
seeing easily how their school's spending compares to other schools in
the district to other stakeholders using the information to participate
in equity conversations on differences within and between states.
What is the Department's plan for ensuring states and school
districts comply with ESSA's policy requiring the reporting of actual
personnel and nonpersonnel expenditures, disaggregated by Federal,
state and local source of funds for each school and school district and
such information is made available to the public in an accessible and
understandable manner?
Answer. The Department will ensure that SEAs and LEAS meet the
report card requirements in ESEA section 1111(h), including the
requirement to report per-pupil expenditure data. As you are aware, to
help facilitate compliance with these requirements, the Department
released non-regulatory guidance on State and local report cards in
September 2019 (available at: https://oese.ed.gov/files/2020/03/report-
card-guidance-final.pdf). This document includes detailed guidance for
SEAs and LEAs regarding how to calculate per-pupil expenditures. The
guidance encourages SEAs to establish uniform statewide procedures for
calculating per-pupil expenditures so that that data are uniform,
understandable, and comparable across each LEA and school in a State.
To help ensure SEAs and LEAs comply with applicable requirements,
including reporting per-pupil expenditures, a complete review of State
and local report cards is included in the Department's Title I, Part A
monitoring protocols, which are found at: https://oese.ed.gov/offices/
office-of-formula-grants/school-support-and-accountability/performance-
review/). An important aspect of our consolidated monitoring is a
thorough review, for each State monitored in a particular year, of the
State's report card to ensure that it includes all required elements.
In addition, each January, the Department reviews each State website to
determine if States and districts were in compliance with certain
report card requirements, including reporting per-pupil expenditure
data. The Department shares the results of its review with each State.
Over the past few years, the Department has initiated several
technical assistance activities through the State Support Network, a
four-year technical assistance contract begun in 2016 to support States
and districts as they transitioned to the new ESSA requirements. Some
of the technical assistance initiatives focused on State and local
report cards, several of which have had a particular focus on per-pupil
expenditure data. For example, in 2018 a community of practice
involving Arkansas, Montana, North Dakota, New Mexico, Nevada, and
Oklahoma focused on improving financial transparency. Other relevant
communities of practice have focused on data quality, State and local
report cards, and resource allocations. Information about these
communities of practice can be found at: https://oese.ed.gov/resources/
oese-technical-assistance-centers/state-support-network/resources/. The
Network also created the ``Financial Transparency and Reporting
Readiness Assessment Tool.'' This tool can help States and districts
meet the ESSA reporting requirements by identifying and analyzing
school level expenditure data. This tool contains two components--a
self-diagnostic framework and an analysis tool--that are designed to
help districts and States understand the dynamics of school-level per-
pupil reporting in their own district financial data. The tool can be
found at: https://oese.ed.gov/resources/oese-technical-assistance-
centers/state-support-network/resources/financial-transparency-
reporting-readiness-assessment-tool/.
The Department is also funding the National Comprehensive Center's
work with Georgetown University's Edunomics Lab to improve the quality
and utility of school-level per-pupil expenditure data that is reported
on State and local report cards as required under ESSA. Edunomics'
initial work through this project involved analyzing the utility and
usefulness of the school-level per-pupil expenditure data reported by
each State (https://edunomicslab.org/state-data-tracker/). The current
phase of the National Comprehensive Center's project with Edunomics is
focused on working with a little under 20 school districts across
different States to analyze each district's school-level expenditure
data and build staff capacity to use data to drive decisionmaking for
school improvement and equitable allocation of resources. After
piloting tools and communication materials with these school districts,
Edunomics will create a data visualization tool that all districts will
be able to access to analyze their school-level per-pupil expenditure
data and use it for finance decisionmaking.
Additionally, the Department's National Center for Education
Statistics (NCES) has been working with over 20 States to improve the
quality of expenditure data reported through a voluntary data
collection. Recently, NCES issued a report on highlights of school-
level finance data that were previously reported (https://nces.ed.gov/
pubs2021/2021305.pdf).
The Department looks forward to expanding and building upon these
efforts.
Question. I appreciate the Secretary's commitment to properly
implementing the American Rescue Plan Act of 2021, including required
state and school district set-asides for evidence-based interventions
that address the academic, social, and emotional needs of students of
color, students experiencing homelessness and other underserved student
groups disproportionately impacted by the pandemic.
Please describe in detail how the Department will support, monitor
and enforce requirements of the Elementary and Secondary School
Emergency Relief Fund (ESSER) related to these set-asides and
implementation of State and district ESSER plans related to these state
and district learning loss requirements.
Answer. We support these requirements through the State plan
process that the Department established, technical assistance efforts,
non-regulatory guidance documents, and ongoing communication with
States through our program officers.
The ARP ESSER State plan template requires grantees to describe how
they will use each required set-aside under the ARP Act. We will
monitor grantees against their approved ARP ESSER State plans as well
as statutory requirements. As needed, the Department will issue any
findings and develop corrective action plans to address those findings.
We are committed to working with grantees to resolve any findings.
In July, the Department issued a notice inviting comment related to
data submission requirements for the ESSER (including ESSER I, ESSER
II, and ARP ESSER) annual performance report (APR). The public is asked
to comment on data quality and burden-related concerns related to
collecting data on evidence-based summer learning or summer enrichment
programs, evidence-based afterschool programs, and extended
instructional time, among other items. After the data collection
instrument is finalized and APR data is submitted, the Department will
review grantee submissions to identify technical assistance needs and
inform future monitoring of grantees.
Question. Department regulations state the Secretary may make a
continuation award for a direct grant for a budget period after the
first budget period of an approved multi-year project if Congress has
appropriated sufficient funds for that purpose and the grantee is
making substantial progress toward meeting the goals of the project,
among other factors. The regulations further state ``In deciding
whether a grantee has made substantial progress, the Secretary may
consider any information relevant to the authorizing statute, a
criterion, a priority, or a performance measure, or to a financial or
other requirement that applies to the selection of applications for new
grants.''
For fiscal year 2018 and 2019, how many direct grantees did not
receive a continuation award for any reason? How many of such denials
were related to the lack of substantial progress on performance? How
much total funding was associated with such denial of a continuation
award due to lack of substantial progress on performance?
Answer. In fiscal years 2018 and 2019, 11 grantees received a
continuation award of $1, which is equivalent to a denial of a
continuation award but is the amount required to keep the grant award
active so grantees can complete work already funded. Of those, 10 were
at least in part because of issues related to substantial progress. The
total amount impacted grantees requested in their initial grant
applications for the budget period not funded is approximately $38
million. In addition, the Department reduced continuation awards for
other grantees if appropriate based on lack of substantial progress or
other considerations. Further, some grantees asked for their
continuation award to be reduced or for the grants to end early due to
their concerns about not being able to implement their projects
Question. What policies or criteria have the Department adopted for
considering information in making a determination of substantial
progress? If none, how does the Department consistently evaluate
substantial progress?
Answer. The Department follows the procedures for non-competing
continuation awards as set forth in 34 CFR 75.253 and has internal
policy about how to determine substantial progress, including what
should be included in documentation for non-competing continuation
award documents. The policy includes considerations to support
decisionmaking, including program- and grantee-specific context,
monitoring grantee performance, and discussing performance concerns
with grantees. There are also internal discussions across offices to
share about office practices and lessons learned, particularly in light
of the COVID-19 pandemic and how best to consider associated
disruptions to the project activities in making substantial progress
determinations.
Question. Earlier this year, the Department withdrew a notice
inviting applications for equity assistance centers (EACs) issued by
the previous administration and extended existing contracts for 1 year.
Equity Assistance Centers can play an important role in addressing
racial and other equity concerns and designing and implementing school
desegregation plans.
What are the Department's plans for the new notice inviting
applications?
Answer. The Department plans to publish a notice inviting
applications for new awards in the Federal Register in early 2022.
Question. How does the Department evaluate the resources needed for
EACs to carry out this important work? Please share any analysis
completed that supports the sufficiency of the $6.5 million requested
for EACs to delivery timely and effective services across the entire
United States.
Answer. We have not carried out any detailed analysis of EAC
resource needs, but we do ask the EAC grantees to tell us in their
annual performance reports the percentage of technical assistance
requests received from organizations that they accepted during the
performance period. Annually across 2017 to 2020, the EACs were able to
accept between 95 percent and 98 percent of the technical assistance
requests they received from the field.
Question. As of June 11, more than sixty percent of the CARES
Elementary and Secondary School Emergency Relief (ESSER) funds ($8
billion of $13.2 billion) have been recorded as spent and outlaid from
the Federal Treasury, while $2.1 billion of $54.3 billion provided
through ESSER in the Coronavirus Response and Relief Supplemental
Appropriations (CRRSSA) Act, 2021 and $25 million of $81 billion
obligated from ESSER funds in the American Rescue Plan (ARP) Act of
2021 have been so reported. The Department also is in the process of
reviewing state plans for the obligation of the remaining one-third of
the ARP ESSER funds. However, earlier this year the Government
Accountability Office reported ``Federal spending data alone provide an
incomplete picture of states' and school districts' spending'' noting
``there is often a significant gap between when a district uses the
funds and when those funds are reported as spent in state and Federal
reporting systems''.
Please describe actions taken and planned by the Department to
provide a more complete reporting of the use and status of ESSER funds.
Answer. Section 15011 of the CARES Act specifies the reporting
requirements for covered programs. Existing reporting requirements,
established under the Federal Funding Accountability and Transparency
Act of 2006 (FFATA), Public Law No. 109--282, as amended by the Digital
Accountability and Transparency Act (DATA Act), Public Law No. 113--
101, were deemed sufficient to meet many of the reporting requirements
for ESSER fund program. Specifically, States were required to report to
the General Services Administration's FFATA Subaward Reporting System
(FSRS), the amount of ESSER funds granted to school districts. These
data are required to be reported directly from States and are made
available to the Department and the public through USAspending.gov.
To further meet the Section 15011 reporting requirements and
additional reporting requirements described within the ESSER
Certification and Agreements, the Department created an annual
reporting process for ESSER grantees (States). The annual report
captures the following information (1) award and outlay information
from the Department to ESSER grantees (States); (2) award and outlay
information from ESSER grantees to their subgrantees (school districts/
LEAs); and (3) subgrantee expenditure data. States were required to
provide these data for district awards/expenditures made March 13,
2020--September 30, 2020 to the Department in early 2021. States will
be required to provide additional reports on ESSER funds annually
thereafter. The current ESSER reporting form is available for review
through: https://api.covid-relief-data.ed.gov/collection/api/v1/public/
docs/ESSER_Data_Collection_Final.pdf.
The Department acknowledges the importance of collecting and
publicly reporting information on school districts' financial
commitments (obligations), as well as outlays in order to more
completely reflect the status of their use of Federal COVID-19 relief
funds. Earlier this year, the Department proposed modifications to its
ESSER annual report on State and school district spending data to
include obligations data in subsequent reporting cycles. The proposed
modifications, in accordance with the Paperwork Reduction Act, are
currently available for public comment on the Federal Register:
(https://www.Federalregister.gov/documents/2021/07/02/2021-14200/
agency-information-collection-activities-comment-request-education-
stabilization-fund-elementary-and).
Question. The Department's fiscal year 2022 Annual Performance Plan
includes plans to identify opportunities to further build and use
evidence in both formula and competitive grant programs.
How many competitive grant programs will include an evidence
priority in fiscal year 2021?
Answer. In fiscal year 2021, 19 competitions required the use of
evidence through a requirement or an absolute priority and 6
competitions included a competitive priority for evidence, and 18
encouraged applicants to rely on evidence by including it in selection
criteria. An additional 2 competitions encouraged the use of evidence,
such as through an invitational priority. Note that two competitions
included evidence in more than one way and are thus counted in multiple
categories. An unduplicated total of 43 competitions, or almost 60
percent of all competitions in fiscal year 2021, included evidence in
at least one of these ways.
Question. How many competitive grant programs does the Department
plan to include an evidence priority in fiscal year 2022?
Answer. The Department is discussing how best to use and build
evidence in fiscal year 2022 competitions in alignment with statutory
requirements, the body of available evidence, and lessons learned from
previous competitions.
Question. Please identify the formula programs in which evidence
building and use will be promoted and supported and the specific
strategies to accomplish these goals.
Answer. The Department is supporting evidence building and use in
the ESEA formula grant programs under Titles I, II, and IV. Evidence is
also important within the context of IDEA formula grant programs. The
Department works with the Comprehensive Centers, the Regional
Educational Laboratories, and the technical assistance centers funded
by the Office of Special Education programs to identify and share
resources related to evidence building and use. To further support the
identification of evidence-based practices, The Institute of Education
Sciences' What Works Clearinghouse has recently added a new feature to
its website--evidence tier ``badges''--making it easier for users to
know whether a given approach meets regulatory definitions of strong,
moderate, or promising evidence. The WWC has also produced a series of
technical assistance materials supporting the use of this feature and
of the site overall. In addition, the Department is providing resources
related to the evidence-based strategies required under the Elementary
and Secondary School Education Relief Fund (ESSER Fund) under the
American Rescue Plan. Within the context of safely reopening all
schools, the Department has created the Safer Schools and Campuses Best
Practices Clearinghouse. The Clearinghouse provides resources for
practices that can be leading examples of how best to provide support
to students and educators.
Question. Please describe efforts the Department has undertaken to
build the internal capacity of staff in the use and implementation of
evidence in activities funded through formula and competitive grant
programs.
Answer. Measuring Skills. In 2020, ED developed and fielded the
inaugural Data and Evidence Use Survey to measure staff skills. In Q3,
the Office of the Chief Data Officer and the National Center for
Educational Evaluation finalized the survey to respond to requirements
of the Evidence Act and the Federal Data Strategy. CDOs in other
agencies, including DHS, Commerce, Labor, and the Air Force have
requested and received ED's survey to support their efforts. The
results of the ED Survey are used to target staff training to improve
data literacy and the capacity to use evidence.
The Evidence Act requires ED to assess its evaluation activities
and agency capacity to support the development and use of evaluation.
Congress explicitly made this requirement an agency-wide focus by
instructing the Evaluation Officer to coordinate activities with agency
officials in carrying out the functions of the Evaluation Officer in
section 313(d) of title 5. Additionally, the Open Government Data Act
requires the Chief Data Officer to support the Evaluation Officer in
identifying and using data to carry out their statutory functions
(Sec. 3520(c)(9)). The Evaluation Officer and the Chief Data Officer
share common interest and authority in carrying out these functions and
collaborate to field the annual Data and Evidence Use Survey.
Enhancing Skills. In 2021 ED launched its new Data Literacy
Program, an intentional commitment to upskilling and continual
learning. The program's goal is to develop a data culture at ED which
enables all staff to speak a shared language around data and evidence.
An expert-based approach was designed with support from The Data Lodge
to provide a comprehensive corpus of flexible training to reach 3,500
staff. A partnership among ED's data office, research office, and human
resources office resulted in a committee of 5 SES and GS15 leaders
(including ED's Evaluation Officer) who developed the program
blueprint. The blueprint mapped out a programmatic approach over 3
years, engaging ED offices in waves of customized, highly interactive
sessions. Learning pathways were developed using Skillsoft. ED also
developed plans for its own developed content and OCDO-led introductory
workshops. Current training consists of four major components: (1) a
hallmark initial, interactive 2-hour session ``Exploring Data
Literacy,'' (2) a one-hour ED-specific session, ``Data Literacy 101''
(3) four self-paced Learning Pathways of SkillSoft and external courses
around evidence, decisionmaking, visualization, and analytics and (4)
Learning Bytes, 15 min interactive topics recorded for easy use.
As ED staff begin to build data literacy, we continue our efforts
to ensure that all staff are increasingly well-versed in the role of
evidence in the work of schools, States, districts, and institutions of
higher education. This past year, the Institute of Education Sciences
and the Office of Planning, Evaluation, and Policy Development's Grants
Policy Office (GPO) began offering ``Evidence 101: Evidence Use at the
Department of Education'' to all new hires each quarter. As part of
that training, new staff are introduced to statutory and regulatory
requirements related to evidence use, the history of evidence use at
the Department, and Department resources that can support their work.
IES and GPO have also worked to build a virtual ``community of
practice'' focused on evidence use based on a monthly newsletter to
staff and associated website, the Evidence Connection. Approximately
250 staff across the Department are currently members and receive
regular updates about resources that can support their efforts to use
evidence in their own work and support the work of Department grantees.
Question. What is the Department's plan for continuing to build
this capacity in the coming year?
Answer. In 2022, the ED Data Literacy Program will advance general
staff ability to use, understand, and apply data and evidence to
support decisionmaking around programs, policy, and operations. In
2022, the program will mature current engagement, curriculum, and
resources. First, our engagement will broaden and deepen. Current Data
Literacy Ambassadors for the first wave of ED offices participating in
the program will customize and deliver existing program resources for
relevant and actionable professional development. We will onboard
additional offices to reach all 3,500 staff. Second, we will expand our
current curriculum and add new courses, both interactive and virtual,
asynchronous training. In 2022, we would like to add 4 major ED-
specific courses featuring ED leaders, data processes, core data
collections, and projects and tools. Lastly, we plan to augment and
enhance resources around data language (e.g., Glossary), expertise
(e.g., Directory) best practices and technology. To address the
specific capacity-building needs of ED data professionals who support
the production of evidence for grant programs, ED launched its new Data
Professionals Community of Practice (DPCoP) in August 2021. In
alignment with ED Data Strategy Objective 2.3 ``Establish clear career
paths and training curriculums for data professionals'', the DPCoP will
be a member-driven collaborative forum open to all ED data
professionals. It will provide opportunities to share resources, tools,
and successful practices in ED, inform leadership of data-related
issues or concerns, and establish workgroups to address specific topics
and challenges.
Question. How will the Department measure the growth of this
capacity and expected improved targeting of resources to activities
authorized by current law and aligned with evidence of effectiveness?
Answer. Evidence Use. As noted above, the Department is currently
fielding the second iteration of its Data and Evidence Use Survey. The
survey provides repeated cross-sectional estimates of ED staff capacity
to use evidence in their work in areas including: (1) designing
performance measures, (2) providing technical assistance on evidence
definitions and requirements, and (3) monitoring grantees for effective
evidence use. These data can be used to inform professional development
opportunities for ED staff and the production of new resources for both
staff and stakeholder use.
Resource Targeting. The Department will continue to work with SEAs,
LEAs, institutions of higher education and other entities to support
and increase the use of evidence to inform decisionmaking.
Question. How does the Department support and monitor SEA and LEA
decisionmaking related to reasonably available determinations for
evidence use under provisions of ESEA? What are the Department's plan
to monitor and further support such determinations?
Answer. To support States, local educational agencies (LEAs), and
schools in understanding the levels of evidence and interventions that
meet them, the Department continues to disseminate information and
provide technical assistance that highlights the evidence levels
associated with a wide range of interventions, strategies, and
approaches. Specifically, the Institute of Education Sciences What
Works Clearinghouse (WWC) provides information on the evidence levels
of interventions, strategies, and approaches on a wide range of topics
through both Intervention Reports and Practices Guides, as well as
individual studies. These user-friendly resources describe the level of
evidence demonstrated, the characteristics of students, and the setting
(urban, rural, suburban) of the research studies included. When
evaluations produced through discretionary grant programs are submitted
to the WWC for review to determine if they meet the evidence levels as
defined in the ESSA, they can be highlighted in the WWC for use in
supporting formula grantees. In addition, the Department's technical
assistance network also produces resources to support their respective
target audiences in understanding and using evidence. For example, this
resource from the Regional Education Laboratory West provides important
considerations for using evidence-based interventions.
With respect to monitoring use of evidence consistent with
statutory and regulatory requirements, the Department includes
questions regarding State and local compliance with evidence
requirements as relevant in its monitoring protocols. In addition to
understanding compliance with these requirements, these monitoring
protocol questions allow program officers to identify areas for future
technical assistance to support States, LEAs, and schools in their
efforts to support student achievement.
Question. Last year, Congress removed a limitation on Federal
education funds that prevented the use of such funds for transportation
costs associated with school integration efforts.
How will the Department and its technical assistance providers work
with state educational agencies (SEAs), local educational agencies
(LEAs) and schools to inform and support them in this use of funds?
Answer. While Congress has removed certain limitations on the use
of Federal education funds for transportation costs related to school
integration plans, section 8526(2) of the Elementary and Secondary
Education Act of 1965 (ESEA; 20 U.S.C. 7906(2)) prohibits ESEA funds
from being used for transportation unless otherwise authorized by the
ESEA. Most ESEA programs, including Title I Grants to LEAs and Title
IV-A Student Support and Academic Enrichment Grants, do not authorize
the use of funds to transport students to or from the regular school
day.
In addition, section 802 of the Education Amendments of 1972 (20
U.S.C. 1652), titled ``Prohibition against busing'' includes a
restriction for the use of funds under ED programs for the
transportation of students or teachers to carry out a plan of racial
desegregation of any school system, subject to certain contingencies.
Question. The previous administration failed to hire sufficient
staff at the Office for Civil Rights, despite increases in
appropriations and direction to do so.
Please describe the impact of each staff member having such a large
caseload on their ability to thoroughly investigate complaints for
associated evidence of systemic discrimination, timely process
complaints, conduct compliance reviews, and monitor corrective actions.
Answer. A critical component of OCR's mission is the prompt
investigation and resolution of complaints. A large per-staff caseload
hinders OCR's ability to discharge this responsibility in a timely
manner, which is also unacceptable to both complainants and recipients.
OCR enforcement staff are required to conduct investigations and make
determinations that are factually accurate and legally sound. Ensuring
that these standards are met is a process that requires careful
consideration of evidence provided by complainants and recipients.
There are no ``short cuts'' to fulfilling OCR's mission. Current
caseload numbers may impact OCR's ability to pursue proactive
enforcement activities--compliance reviews and directed
investigations--as well as effectively address an anticipated increase
in complaints. In short, large caseloads can slow the delivery of
justice for complainants and disserve school districts and
postsecondary institutions that need guidance from the Department to
ensure that they provide all students with an environment that is free
from discrimination.
Question. How would the additional staff requested in the budget be
utilized to enable OCR to more effectively fulfill its mission?
Answer. The majority of the additional staff will be utilized to
resolve complaints and proactive activities (compliance reviews and
directed investigations). OCR also requested additional legal staff
that will develop policy guidance and regulatory materials for civil
rights enforcement. Additional administrative staff will respond to
Freedom of Information Act (FOIA) requests and help reduce the FOIA
backlog and support Civil Rights Data Collection. Requested
administrative staff are also needed to provide oversight of OCR's IT
security, systems operations, website and records management.
Question. With respect to the Charter School Grants program, the
fiscal year 2022 Congressional Justification indicates: ``The
Department will work to ensure that Charter Schools Grants funds
support schools that are opened and operated with demonstrated family
and community support, serve students from diverse racial and
socioeconomic backgrounds, provide meaningful access to instruction for
students with disabilities and English learners, maintain diverse
educator workforces, and are subject to strong accountability,
transparency, and oversight.'' The document also indicates that 14
state entity grantees provide or plan to provide technical assistance
to charter school subgrantees in meeting the needs of students with
disabilities, while 13 provide or plan to provide technical assistance
to subgrantees in meeting the needs of English learners.
Please describe how the Department will accomplish each of the
objectives outlined above.
Answer. The Department looks forward to working with you and with
other stakeholders to address these important priorities.
Question. What does the Department know about the evidence base
supporting the state entity technical assistance strategies for
students with disabilities and English learners? With which tier, if
any, of the definition in section 8101(21)(A) of the Elementary and
Secondary Education Act (ESEA) do they align?
Answer. The program statue does not require applicants to propose
evidence-based technical assistance strategies, as such, information
regarding the evidence base for specific state entity (SE) technical
assistance strategies implemented by SE grantees to support students
with disabilities and English learners was not examined as part of the
review referenced in the program's Congressional Justification.
Question. Please describe how the Department would use national
activities funds available in fiscal year 2022 or supported by fiscal
year 2022 appropriations for each of the national activities
authorities available under the ESEA.
How would these plans be informed by evidence of effectiveness and
the needs of those served by each of the authorities?
Answer. The Department does not yet have detailed plans for
national activities in fiscal year 2022, since most planning for
discretionary grant programs, including national activities
authorities, takes place in the summer and fall prior to the beginning
of the fiscal year. In addition, such plans depend in part on
completion of final appropriations action, which includes both final
funding levels and any applicable Congressional priorities for the use
of national activities funds. Consideration of the needs of those
served by our programs, as well as maximizing the use of evidence-based
practices in meeting those needs, is the starting point for the
Department's planning process.
Question. Under the Every Student Succeeds Act, SEAs and LEAs were
required to develop plans for how they will identify and address the
disparities of low-income and minority children being
disproportionately taught by ineffective or inexperienced teachers.
How does the Department plan to support the timely implementation
of such plans, including through the use of funds appropriated and
requested for Title II-A of ESEA and other current law authorities?
Answer. ESEA section 1111(g)(1)(B) requires each SEA to describe
how low-income and minority children enrolled in Title I, Part A
schools are not served at disproportionate rates by ineffective, out-
of-field, or inexperienced teachers, and the measures the SEA will use
to evaluate and publicly report the progress of the SEA with respect to
such description. Consistent with ESEA section 8302, the Department
determined that this description was required as part of the
consolidated State plan. Thus, each SEA was required to provide a
description and how it will publicly report its progress in addressing
any identified disparities. This provision does not require each SEA to
submit a plan to the Department regarding how it will address those
disparities. Information about the ESSA Consolidated State Plan,
including each State's plan, can be found at: https://oese.ed.gov/
offices/office-of-formula-grants/school-support-and-accountability/
essa-consolidated-state-plans/.
The Department includes a review of this requirement in our
monitoring protocols for Title I, Part A (available at: https://
oese.ed.gov/files/2020/08/SEA-Protocol-Title-I.docx). The Department
requires each SEA monitored to describe how it evaluated its progress
toward ensuring that low-income and minority children in Title I
schools are not served at disproportionate rates by ineffective, out-
of-field, and inexperienced teachers and requests updated educator
equity data. The Department also requires each SEA to describe how it
publicly reported its progress toward meeting this requirement and asks
for documentation of public reporting. Finally, the Department asks
each SEA to describe how it supports LEAs in meeting this requirement.
The SEA must describe how it ensures each LEA receiving a Title I, Part
A subgrant identifies and addresses disparities resulting in low-income
and minority students having disproportionate access to ineffective,
out-of-field, and inexperienced teachers and requests that the SEA
provide the following documentation, if applicable: LEA plan template
reflecting this requirement; SEA guidance for LEAs related to equitable
access to educators; and/or SEA monitoring protocol that demonstrates
the SEA is verifying compliance with this requirement.
In our review of States over the past several years, the Department
has issued two monitoring findings related to these requirements. In
2020, the Department cited Kentucky for two issues: 1) the State
publicly reported inaccurate educator equity data; and 2) the State did
not adequately document how it ensures that each LEA receiving a Title
I subgrant identifies and addresses disparities resulting in low-income
and minority students having disproportionate access to ineffective,
out-of-field, and inexperienced teachers. In 2019, the Department
issued a finding for New Jersey because although the State provides
LEAs with multiple sources of related data, NJDOE is not currently
evaluating or publicly reporting its progress in ensuring that low-
income and minority children in Title I, Part A schools are not served
at disproportionate rates by ineffective, inexperienced, and out-of-
field teachers. The Department also issued a recommendation that New
Jersey incorporate the requirement in ESEA section 1112(b)(2) in the
State's subrecipient monitoring protocol to ensure that LEAs are
meeting the statutory requirements to ensure that low-income and
minority children in Title I, Part A schools are not served at
disproportionate rates by ineffective, inexperienced, and out-of-field
teachers. The reports for Kentucky and New Jersey (and all information
related to the Department's consolidated monitoring, can be found at:
https://oese.ed.gov/offices/office-of-formula-grants/school-support-
and-accountability/performance-review/).
Regarding the use of Title II, Part A funds, the ESEA consolidated
State plan asks each State to describe how it will use Title II, Part A
funds to address this requirement, if it chooses to do so. In addition,
the Department conducts an annual use-of-funds survey that asks SEAs to
account for how State-level Title II, Part A funds are used. In school
year (SY) 2019-2020, the most recent year for which survey data are
available, 20 States indicated that they had spent at least some of
their State-level Title II, Part A funds on activities to improve
equitable access to effective teachers. The Department also conducts an
annual survey on how LEA-level Title II, Part A funds are used; this
survey is distributed to a nationally- and State-level-representative
sample of LEAs in the country. In the survey covering expenditures in
SY 2029-2020, 34 percent of responding LEAs indicated that they had
spent at least some of their Title II, Part A funds on strategies to
recruit, hire, and retain effective educators, although it is not clear
if these expenditures specifically focused on ensuring equitable access
effective educators in the districts. Additional detail on the results
of the 2019-2020 surveys on how Title II, Part A funds were used is
available at https://ies.ed.gov/ncee/pubs/2021011/index.asp.
The Department looks forward to expanding and building upon these
efforts.
Question. Analysis of CDC data and other reports indicate a
reduction in routinely recommended vaccination of children and youth
last year resulting from the disruption to routine healthcare caused by
the COVID-19 pandemic. Lack of proper vaccinations could provide an
additional challenge to the return to in-person learning in the fall.
How is the Department working with HHS to support the vaccination
of children and youth needed for school enrollment for in-person
learning?
Answer. The Department is working to support HHS/CDC in the
dissemination of guidance on vaccination of children and youth in the
following manner:
--Collaborated and hosted a number of webinars to share mitigation
strategies and guidance with the educators, school personnel,
families, education stakeholders, and public
--Participated in bi-weekly ED/CDC planning calls to coordinate and
organize scheduled webinars with HHS/CDC and the Department
--Posted resource materials on the Department of Education website,
federally supported National Technical Assistance websites, as
well the newly launched Safer Schools and Campuses Best
Practices Clearinghouse (https://
Bestpracticesclearinghouse.ed.gov)
--Participated in weekly established ED/CDC K-12 Touchbase calls to
share information/research/guidance/upcoming agency planned
activities
--Released Guidance Handbooks for the education community and
included information on the topic
Question. The Department is developing supplemental priorities that
may be applied to fiscal year 2022 and future grant competitions. The
fiscal year 2022 Congressional Justification cites building and
enhancing the instructional skills of a more diverse educator workforce
as one possible supplemental priority.
What other supplemental priorities may be applied in fiscal year
2022 competitions?
Answer. The Department published a Notice of Proposed Priorities on
June 30, 2021. There are six draft priorities: (1) Addressing the
Impact of COVID-19 on Students, Educators, and Faculty; (2) Promoting
Equity in Student Access to Educational Resources, Opportunities, and
Welcoming Environments; (3) Supporting a Diverse Educator Workforce and
Professional Growth to Strengthen Student Learning; (4) Meeting Student
Social, Emotional, and Academic Needs; (5) Increasing Postsecondary
Education Access, Affordability, Completion, and Post-Enrollment
Success; and (6) Strengthening Cross-Agency Coordination and Community
Engagement to Advance Systemic Change.
Question. Please identify the programs in which supplemental
priorities will be applied.
Answer. The public comment period on the Notice of Proposed
Priorities closed on July 30. The Department is reviewing the comments
received and is considering how best to incorporate the Secretary's
priorities in fiscal year 2022 competitions once the priorities are
finalized.
Question. The budget includes $180 million, an increase of $15
million more than the fiscal year 2021 LHHS bill, for the National
Assessment of Educational Progress (NAEP). The requested funds would
maintain the current assessment schedule and provide funding for
initial research and development investments intended to improve
assessment quality and reduce future program costs. Over the past year,
staff of the Department, National Center for Education Sciences and
National Assessment Governing Board have provided informative updates
on COVID-19-induced changes to the NAEP schedule and cost increases.
Please provide:
A description of the policies and procedures implemented to ensure
sufficient oversight and monitoring of contracts, including cost
controls.
Answer. All Institute of Education Sciences (IES) acquisition
activities, including NAEP, adhere to the Department's internal control
strategies, policies, and procedures, with support from the
Department's Contracts and Acquisition Management (CAM) team and Budget
Service:
--Budget Service reviews every planned and on-going contract over
$100k. The Budget Service team reviews, approves, and allots
funds in the Department's payment management system before
funds can be obligated to support payments to vendors (by CAM).
--CAM ensures that new and current contracts are legal and consistent
with the Federal Acquisition Regulations (FAR). Contracting
Officers (who possess warrants to sign off on new acquisitions
and day-to-day commitments) independently review every invoice
submitted by vendors before payment to ensure that costs are
allowable. CAM also partners with IES to validate that FAR
requirements are maintained across the lifecycle of every
individual Assessment contract.
In the Department's most recent A-123 internal control entity level
review of IES, completed in Fall 2020, IES (including the Assessment
Division) provided evidence that IES meets and effectively implements
all 17 GAO Green Book principal areas across all five GAO Internal
Control component areas. IES recognizes that we need to do more to
better anticipate the challenges of increased cost and uncertainties
related to our assessment activities and unforeseeable events such as
COVID-19.
IES recently established an Acquisition Program Management Office
(PMO) that is focused on modernizing IES acquisition practices to
better align with our business model and improve outcomes for
customers. IES also recently awarded a small contract to conduct an
independent validation and review of our current controls and funds
management practices for the Assessment program. We initiated this
contract in part due to the rising costs of assessments, reflected in
the 2019 NAEP Alliance contracts, and in part due to the recent volume
of unplanned and unforeseen task revisions and cost adjustments within
the NAEP Alliance contracts resulting directly from COVID-19. We expect
the results of this quick-turnaround review at some point early in the
2022 calendar year.
Question. The amount and descriptions of additional funding needed
in each of fiscal year 2022, fiscal year 2023 and fiscal year 2024 for
research and development investments;
Answer. The requested $15 million increase would support NAEP
operations to fiscal year 24 and beyond for the current assessment
schedule and would begin to support necessary R&D investments. However,
we anticipate that additional investments would be needed in future
years both to maintain NAEP as the gold standard of large-scale
assessments and to produce cost savings and efficiencies in program
administration costs over time (see responses to 1d and e below).
We also note that while this response is based on the most accurate
budgetary estimates currently available, there may be adjustments to
these estimates based on additional modifications to NAEP alliance
contracts in response to the impact of COVID-19 on NAEP activities.
Estimated Allocations to Operations and R&D based on increase of
$15 million per year (as of 8.4.21)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Funding stream FY22 FY23 FY24 FY25 FY26 FY27 FY28 approp
--------------------------------------------------------------------------------------------------------------------------------------------------------
Operational..................................................... $14M $10M $12M $12M $12M $12M $12M $84M
Current R&D\*\.................................................. $1M $5M $3M $3M $3M $3M $3M $21M
Total....................................................... $15M $15M $15M $15M $15M $15M $15M $105M
--------------------------------------------------------------------------------------------------------------------------------------------------------
\*\See response to question 1d below for current R&D activities.
Question. The amount of additional funding needed in each of fiscal
year 2022, fiscal year 2023 and fiscal year 2024 for operating costs;
Answer. Please see the response to 1b. above. Based on the best
estimates available at this time, the requested $15 million increase
would support operational funding needs through fiscal year 2024;
however, as noted above, it may not fully support currently planned R&D
efforts.
Question. Studies planned and other actions necessary for
maintaining the continuity and integrity of NAEP in any changes
implemented to reduce future program costs;
Answer. We have a number of actions planned to achieve
efficiencies, starting in 2022. These include (i) transitioning to
online assessments, (ii) transitioning from Surface Pro tablets to more
cost-efficient devices in the short term and to school-owned devices in
the longer term, (iii) introducing automated scoring, (iv) reducing the
number of field staff needed to conduct the assessments, and (v)
implementing design changes, including adaptive testing and two-subject
design. Each change will be carefully studied in multiple rounds of
reviews to first explore feasibility and examine effect(s), if any, on
student performance. If any effect on student performance is detected,
IES will need to implement a bridge study to account for the effect and
maintain trends.
Question. Expected savings and supporting information by fiscal
year associated with research and development investments for reducing
future program costs; and
Answer. We expect to realize savings beginning in fiscal year 2024
as currently funded R&D efforts in automated scoring and the eNAEP test
platform take effect. These savings, which are measured against
estimated costs on the current NAEP platform in the absence of proposed
R&D-based modernization efforts, will grow through fiscal year 2030
assuming IES is able to implement fully its planned R&D investments on
eNAEP, which would enable NAEP to be administered on less costly
devices, including school equipment (device agnostic), and with reduced
NAEP field staff. We also note that the capacity to test individual
students in multiple subjects using such devices should dramatically
reduce student and school sample sizes, yielding further savings.
Estimated savings by two-year NAEP cycle are in the table below. Total
expected savings associated with current (and planned future R&D)
investments over the period are approximately $98 million. Note that
these estimated savings assume increased R&D funding in future years.
------------------------------------------------------------------------
Expected
Two-year cycle Savings
------------------------------------------------------------------------
FY23--24..................................................... $4M
FY25--26..................................................... $20M
FY27--28..................................................... $42M
FY29--30..................................................... $32M
Total.................................................... $98M
------------------------------------------------------------------------
Question. Potential additional reductions to future program costs
or program enhancements resulting from recommendations made under
current contract with National Academies of Sciences, Engineering, and
Medicine.
Answer. An independent expert panel convened by the National
Academies of Sciences, Engineering, and Medicine (NASEM) is currently
underway. This 17-month study focuses on how NAEP might modernize its
operations and reduce costs through innovations such as those mentioned
in (d) above. We expect that NASEM's recommendations, once released in
February 2022, will help further refine current plans for
modernization. Some of the innovations under consideration by NASEM are
not expected to result in cost savings (e.g., adaptive testing), but
could improve measurement quality, especially for students scoring at
below NAEP Basic level.
Question. The current NAEP assessment schedule outlines plans to
conduct the Long-Term Trend (LTT) assessment for 17 year-olds in 2022
as a result of the delay caused by the COVID-19 pandemic. However, also
repeating the LTT for 9-year-olds in 2022 would provide nationally
representative information on the impact of COVID-19 on reading and
math learning, including for students of color. This kind of
information would be one type of information and research on learning
loss intended to be funded by the $100 million provided to the
Institute of Education Science by the ARP.
Will the assessment schedule be changed to collect this important
information?
Answer. Yes. NCES and NAGB agreed that the NAEP schedule should be
changed to collect this important information for age 9-year-olds in
2022, while canceling the LTT for 17-year-olds. NAGB will take an
official vote on the change to the schedule at the August meeting.
Additionally, preparation for both LTT age 9 and age 17 would be
unsustainably expensive given available funding and the expected $8m
cost for each of these age groups. That is, preparation for paper
booklets, quality control reviews, printing, and distribution could not
be done for both cohorts given anticipated budget shortfalls in 2024.
Accordingly, we put preparations for LTT age 17 on hold in June based
largely on cost considerations. NCES has also confirmed that it is too
late to restart preparation work for age 17, even if funds were made
available.
Question. If the LTT for nine year olds was not paid for with funds
available to IES in the ARP, how would such a change impact the NAEP
2021 operating plan? How would such an additional cost for LTT impact
the rest of the currently approved assessment schedule? Please provide
a revised operating plan.
Answer. The Department considered using ARP funds for LTT but
decided against doing so because of legal concerns with using ARP funds
for research. Regarding the impact on the NAEP budget, since the data
collection costs for the two cohorts are comparable, changing from an
assessment of 17-year-olds to 9-year-olds would have no real effect on
anticipated outlays. The anticipated shortfall in 2024 would remain the
same if the requested $15 million increase in fiscal year 2022 is not
enacted.
We note that in 2025 the schedule calls for all three ages, 9, 13,
and 17 to be collected again as part of a bridge study to transition
the assessments from paper to digital formats.
Question. ESEA contains provisions on parent and family engagement
under ESEA programs and authorizes support for Statewide Family
Engagement Centers. These ESEA provisions include a 1 percent set-aside
of LEA Title I-A allocations for effective parent and family engagement
activities, along with requirements for parent, family and community
engagement activities using English Language Acquisition funds.
What are the Department's plans for supporting SEAs and LEAs in
implementing parent and family engagement requirements under section
1116 of ESEA, including in identifying and overcoming barriers to
greater participation by parents who have limited English proficiency
or are of any racial or ethnic minority background?
Answer. The Department administers the Statewide Family Engagement
Centers program which is authorized under Title IV, Part E of the
Elementary and Secondary Education Act of 1965, as amended. The purpose
of the SFEC program is to provide financial support to organizations
that provide technical assistance and training to SEAs and local
educational agencies LEAs in the implementation and enhancement of
systemic and effective family engagement policies, programs, and
activities that lead to improvements in student development and
academic achievement. For those families from diverse background and
who have limited English proficiency, there are 12 statewide family
engagement centers across the country that (1) carry out parent
education and family engagement in education, programs and (2) provide
comprehensive training and technical assistance to SEAs, LEAs, schools
identified by SEAs and LEAs, organizations that support family-school
partnerships and other such programs.
In addition, the Department administers the Comprehensive Centers
program, which is authorized under Title II, Sec. 203, of the
Educational Technical Assistance Act of 2002. The Comprehensive Centers
address needs identified by SEAs in meeting ESEA student achievement
goals, as well as priorities established by states. As part of this
work, Comprehensive Centers have developed resources on various topics
(e.g., literacy instruction) to support SEAs, LEAs, and educators.
Building SEA and LEA capacity to engage parents and families is a key
element of this support (e.g., Evidence Based Literacy Instruction:
Families as Partners). Comprehensive Centers have also developed
resources that specifically focus on establishing and nurturing
successful school-family relationships. Finally, parent and family
engagement has played an important role in the Summer Learning and
Enrichment Collaborative (SLEC). Several SLEC sessions have provided
SEAs, LEAs, and other participants with support on developing
partnerships for family engagement in high-needs communities, creating
authentic partnerships with marginalized families and communities, and
meeting whole student and family needs through collaborative
partnerships at school.
The Department looks forward to expanding and building upon these
efforts.
Question. How does the Department monitor and support the
coordination and integration of parent and family engagement strategies
under Title I-A with other relevant Federal programs?
Answer. Under ESEA section 1116, an LEA receiving Title I, Part A
funds must develop a written parent and family engagement policy in
collaboration with parents and family members of participating
students. Among other things, the policy must describe how, to the
extent feasible, the agency will coordinate and integrate Title I
parent and family engagement strategies with strategies under other
relevant Federal, State, and local laws and programs. An LEA's policy
also must describe how it will annually evaluate of the content and
effectiveness of the parent and family engagement policy, including
identifying barriers to participation, with particular attention to
parents who are economically disadvantaged, disabled, have limited
English proficiency, have limited literacy, or are of any racial or
ethnic minority background. The Department monitors ESEA section 1116,
Parent and Family Engagement, as part of the Title I, Part A monitoring
protocol (available at: https://oese.ed.gov/files/2020/08/SEA-Protocol-
Title-I.docx). Within the protocols, the Department specifically asks
each SEA it monitors to describe how it reviews LEA parent and family
engagement policies and practices to ensure the LEA meets the
requirements of section 1116, including those referenced above. In
addition, the Department asks each SEA to describe how, in its review
of the LEA's parent and family engagement policies and practices, it
ensures that the LEA's parent and family engagement policies provides
opportunities for the participation of all parents and family members
(including parents and family members who have limited English
proficiency, parents and family members with disabilities, and parents
and family members of migratory children) and provides information and
school reports, in a format and, to the extent practicable, in a
language that parents understand. The Department asks that each SEA
submit its process to review LEA policies and procedures for family
engagement as evidence during the monitoring review.
Additionally, the Department of Education has an Office of
Communications and Outreach that has a Family and Community Engagement
Team. The goal of the Team is to expand efforts to help schools,
districts, and states better engage families in education. This team
works to monitor and support the coordination and integration of parent
and family engagements strategies under Title I, Part A (and other
Titles) with other relevant Federal programs.
Question. The fiscal year 2022 Annual Performance Plan identifies a
goal of improving access to quality educational programs in
correctional settings.
Please identify the programs and strategies involved in improving
access to quality educational programs in correctional settings.
Answer. The Office of Career, Technical, and Adult Education's
Integrated Education and Training (IET) in Corrections Project will
identify, develop, and document IET in corrections models to
demonstrate how to extend existing secondary-postsecondary pathway
models to include the corrections system. The project is intended to
provide strategies that can be disseminated and replicated.
Second Chance Pell (an Experimental Site Initiative) launched in
2016 and allowed 67 colleges and universities enroll incarcerated
students using Pell Grants on an experimental basis. In 2020, the
program was expanded to allow an additional 67 colleges and
universities to serve even more students. On July 30, 2021, the
Department announced a further expansion of Second Chance Pell to gain
critical insights about how to reinstate Pell Grant eligibility within
correctional facilities, consistent with the implementation of the
provisions of the Consolidated Appropriations Act of 2021 that will
expand Pell Grant eligibility for all eligible incarcerated students on
July 1, 2023. The Department has announced plans to publish regulations
on the program prior to its implementation and held public hearings in
June of 2021 to that end.
The Department has already taken steps to implement changes to the
Free Application for Federal Student Aid (FAFSA), which incarcerated
students and education institutions alike have reported as a major
stumbling block in implementing college-in-prison programming. For
example, for the 2021-2022 award year FAFSA, the Department has removed
the impact of responses to questions about Selective Service
registration and requirements around drug convictions. These questions
will be removed entirely from future FAFSAs.
Question. How will the Department work with relevant Federal
agencies on this goal?
Answer. The Department currently staffs interagency working groups
including the Federal Advisory Committee on Juvenile Justice, the Legal
Aid Interagency Roundtable, and the Interagency Working Group for Youth
Programs. The Department liaises on a regular basis with other Federal
agencies including the Departments of Justice, Labor, Health and Human
Services, and the Consumer Financial Protection Bureau to update these
agencies on Departmental initiatives, such as Pell reinstatement, that
are focused on quality educational program in correctional settings.
The Department also works collaboratively with these agencies as they
implement programming for incarcerated.
Question. CRDC data from the 2017-18 school year survey show that
Black students represented 15 percent of student enrollment but 38
percent of students who received one or more out-of-school suspensions.
Such discipline contributes to lost instructional time and negative
life outcomes.
Please describe planned activities for how the Department will
support a reduction in racial disparities in school discipline.
Answer. The Department is aware of these and other disparities in
the administration of school discipline nationwide--and the adverse
impacts that these disparities have on students--and is actively
planning to address these issues. The Department anticipates issuing
new guidance following its 2018 rescission of the Dear Colleague letter
on Nondiscriminatory Administration of School Discipline and related
materials, which provided guidance to schools on how to identify,
avoid, and remedy discrimination based on race, color, or national
origin in the design and administration of school discipline and create
a positive school climate. As part of that process, on May 11, 2021,
the Department's Office for Civil Rights (OCR) and the Civil Rights
Division of the U.S. Department of Justice organized a virtual
convening session, Brown 67 Years Later: Examining Disparities in
School Discipline and the Pursuit of Safe and Inclusive Schools, where
students, educators, school administrators, civil rights lawyers, and
researchers considered the impact of exclusionary school discipline
policies and practices on our nation's students, particularly students
of color, students with disabilities, and LGBTQ+ students. As a follow
up to the convening, on June 8, 2021, OCR published a Request for
Information (RFI), seeking public comments on what guidance schools and
school districts need to ensure all students attend welcoming,
supportive, and safe schools. As stated in the RFI, OCR recognizes that
students may experience multiple forms of discrimination at once and
encourages commenters to identify and address individual and
intersectional discrimination as appropriate. OCR expects that the
public comments in response to the RFI will inform future decisions
about what policy guidance, technical assistance, or other resources
would assist schools that serve students in pre-K through grade 12 with
designing and administering school discipline in a nondiscriminatory
manner and improving school climate and safety. The comment period for
the RFI closed on July 23, 2021, and OCR is in the process of reviewing
the comments received.
Question. The fiscal year 2022 President's budget proposes to
continue authority for performance partnership pilot and proposes a
priority for such pilots to include communities disproportionately
impacted by COVID-19.
What are the Department's plans for inviting new applications for
performance partnership pilots?
How will these pilots be informed by the national evaluation
released earlier this year, including the recommendations for more
planning time, additional guidance and technical assistance, and
support of systems change through developing and implementing related
metrics?
Answer. The Department, as part of the ongoing Administration
transition, is continuing to evaluate the lessons learned from previous
Performance Partnership Pilots for Disconnected Youth (P3), including
recommendations from the national evaluation, and how best to position
the program for maximum impact in the context of State and local needs
arising from the COVID-19 pandemic (including any flexibilities that
could facilitate more effective use of ARP funds), as well as other
Administration priorities.
Question. The ``Foundations for Evidence-Based Policymaking Act of
2018'' includes key provisions related to developing a multi-year
learning agenda, evaluation plan, improving coordination of data
government at the Department, and improving accessibility of education
data.
What is the Department's timeline for release of its multi-year
learning agenda? Please describe stakeholder consultations that have
occurred or will occur during its development.
Answer. Per OMB guidance, the Department will publish its multi-
year Learning Agenda for fiscal year 22-26 in February 2022, concurrent
with the release of the President's fiscal year 2023 Budget.
Consultation with stakeholders will include a broad Request for
Information published in the Federal Register, along with targeted
outreach to specific communities based on their role (e.g., chief state
school officers) or area of emphasis (e.g., researchers focused on, or
advocacy organizations related to, Federal student aid).
Question. When will the Department release its evaluation plan?
Answer. Per OMB guidance, the Department will publish its fiscal
year 2023 Annual Evaluation Plan in February 2022, concurrent with the
release of the Presidents' fiscal year 2023 Budget. The Department's
fiscal year 22 Annual Evaluation Plan, which was delayed so that
elements of the document could be better aligned to the Secretary's
priorities and the Department's strategic planning efforts, will be
posted in August 2021 to https://ed.gov/data.
Question. What is the Department's timeline for implementing other
provisions of the Act?
Answer. ED's implementation of the Evidence Act is informed by the
recommendations of the Commission on Evidence-Based Policymaking, the
Federal Data Strategy's Principles and Practices, and the Office of
Management and Budget's Phase 1 guidance on Evidence Act implementation
(M-19-23). Our implementation also is informed by discovery and
assessment activities in our own agency that led to a coherent ED Data
Strategy that now serves as ED's roadmap to data maturity.
The ED Data Strategy--the first of its kind for the U.S. Department
of Education--was released in December of 2020. The four ED Data
Strategy goals are highly interdependent with cross-cutting objectives
requiring a highly collaborative effort across ED's offices.
--The strategy calls for strengthening data governance to administer
the data it uses for operations, answer important questions,
and meet legal requirements. To that end, we are developing a
holistic agency-wide framework with established data governance
structures, functions, roles, policies, and procedures and
developing a comprehensive data quality framework for the
agency.
--To accelerate evidence-building and enhance operational
performance, it requires that ED make data more interoperable
and accessible for tasks ranging from routine reporting to
advanced analytics. To inform decisionmaking processes, we are
working to connect fragmented data from disparate sources, so
we can answer critical questions, and strengthen grant
programs' performance and accountability measures.
--The high volume and evolving nature of ED's data tasks necessitates
a focus on developing a workforce with skills commensurate with
a modern data culture in a digital age. We are developing an ED
data workforce plan to support long-term planning for our data-
related human capital needs; we are also building the capacity
of our data workforce while we increase data literacy among all
staff.
--At the same time, safely and securely providing access for
researchers and policymakers helps foster innovation and
evidence-based decisionmaking at the Federal, state, and local
levels. Aligned with these efforts, we are developing an Open
Data Plan, while awaiting OMB guidance on final requirements
for that plan; we are also building toward a comprehensive data
inventory to catalog data assets for both external open data
and internal sources and will incrementally expand the number
of Department data assets listed in the Federal Data Catalog.
Achieving the four ED Data Strategy goals requires a concerted
effort to address short-term challenges and thoughtfully set a course
for long-term data maturity. Each Goal includes a set of objectives--
designed to be completed in the next 12 to 18 months--that form an
action plan for tackling short-term challenges to continue building the
foundation of a data-driven culture. Future objectives under the four
goals will iteratively represent the next set of implementation
challenges to raise ED offices and the agency as a whole to an even
higher level of data maturity.
______
Questions Submitted by Senator Richard J. Durbin
Question. The Department notified me and other Members of Congress
on February 13, that Secretary DeVos had decided not to extend the
closed school discharge look-back period for students who attended
schools owned by Education Corporation of America (ECA). As the
Department has previously stated, ``during the months of March, April,
and May 2018, ACICS placed many locations of ECA on either campus-level
show-cause or campus-level compliance warning due to student
achievement rates'' and on ``May 8, 2018, ACICS placed ECA on show-
cause due to adverse action by another agency.''
Actions toward the removal of accreditation are a clear example of
exceptional circumstances as provided under 34 CFR Sec. 685.214. Will
you reconsider this decision?
Answer. Question answered elsewhere in this document.
Question. In that same February notification, the Department noted
that Secretary DeVos had not yet made a decision on the request from me
and other Members of Congress made on December 21, 2018, to extend the
look back period for Vatterott students--which also met the exceptional
circumstances bar in the law.
Will you look into this matter and render a decision?
Answer. The Department is cognizant of the significant harm to
students that occurs when a college suddenly closes. We are reviewing a
number of school closures to determine whether an extension of the
look-back window is appropriate, and hope to be able to share more on
the results of that review soon.
Question. On June 23, 2021, the Department provided a response to a
letter I sent on October 29, 2020, with several colleagues to then-
Secretary DeVos. Secretary DeVos failed to respond. Your Department's
response mentioned the announced rulemaking in several of the areas
mentioned in the letter--including closed school discharge.
While I'm pleased the Department is taking up many of these issues
in rulemaking, when can we expect a decision from you to the specific
requests in the letter--related to extending closed school look-back
dates?
Answer. We are reviewing a number of school closures to determine
whether an extension of the look-back window is appropriate, and hope
to be able to share more on the results of that review soon.
Question. Since June 2018, the Department has released borrower
defense data on a quarterly basis:
Please provide a breakdown of ``total denied'' borrower defense
claims to date by institution.
Answer. Beginning in December 2019, the term ``total denied'' was
no longer used in the quarterly borrower defense reports. The term
``total ineligible'' is used to refer to applications in which the
borrower has been notified that their claim does not meet the
requirements for a borrower defense to repayment discharge.
Question. Please provide a breakdown of ``total ineligible''
borrower defense claims to date by institution.
Answer. An Excel file providing the requested data as of June 30,
2021, is enclosed.
Question. Please provide a breakdown of ``total closed'' borrower
defense claims to date by institution.
Answer. An Excel file providing the requested data as of June 30,
2021, is enclosed.
Question. How many schools are being investigated for misconduct
due to borrower defense claims filed by their students?
Answer. The Department does not comment on deliberative,
preliminary, or ongoing investigative work, including disclosing a
number or list of institutions that may be subject to such work until
the outcomes of any investigations have been issued to the institutions
or entities. Nevertheless, the Department notes that it has opened
numerous investigations in 2021 and will be holding schools accountable
where appropriate. For schools with findings of misrepresentation or
misconduct, the Department will use evidence in connection with our
borrower defense fact-finding process.
Question. Please provide a list of for-profit colleges for which
the Department is aware of pending state or Federal investigations or
lawsuits--and the corresponding state or Federal entities.
Answer. The Department does not maintain a formal list of for-
profit colleges with pending state or Federal investigations or
lawsuits. However, the Department collaborates closely with law
enforcement partners where appropriate and requests evidence and input
when their investigations of for-profit colleges result in evidence
that the Department may consider in connection with its efforts to hold
schools accountable.
Question. For how many borrowers whose borrower defense
applications have been approved has the Department or its agents made
corrected reports to credit reporting agencies? What percentage?
Answer. FSA requires our vendors to remove the credit tradeline for
any loans that are approved for 100 percent borrower defense relief.
Question. How many and which institutions is the Department
currently investigating for purposes of making findings related to
borrower defense?
Answer. The Department does not comment on deliberative,
preliminary, or ongoing investigative work, including disclosing a
number or list of institutions that may be subject to such work until
the outcomes of any investigations have been issued to the institutions
or entities. To the extent that a Department investigation results in
obtaining evidence that may be relevant to borrower defense claims, the
evidence will be given to FSA's Borrower Defense Group for use in its
fact-finding process. Additionally, the Department is in the process of
increasing staffing within FSA's Investigations Group to advance these
efforts.
Question. Since the 2014 collapse and 2015 bankruptcy of Corinthian
Colleges, Inc., many for-profit colleges have followed suit--closing
their doors as part of a planned teach-out or shuttering precipitously.
In these cases, students are eligible for Federal closed school
discharges. Many are also eligible for Federal student loan discharges
through the Higher Education Act's borrower defense provision as a
result of their institution's fraud and misconduct. We cannot let
students be left holding the bag. At the same time, the Department's
enforcement failures, failures to hold accreditors accountable,
attempts to roll back the Gainful Employment and Borrower Defense
rules--including provisions allowing students to hold institutions
directly accountable in court for misconduct--mean that taxpayers are
ultimately on the hook.
Please provide the cumulative cost of approved closed school and
borrower defense discharges (including automatic closed school
discharges under the 2016 Borrower Defense rule) associated with for-
profit colleges since 2014.
Answer. As of June 30, 2021, the cumulative effectuated closed
school and borrower defense discharges amount is approximately $2.2
billion. This includes almost $1.1 billion in borrower defense
discharges and more than $1.1 billion in closed school discharges,
including automatic closed school discharges. The Department is
continuing to process the discharges of the roughly 91,800 borrower
defense approvals that have been announced in press releases in recent
months.
Question. Please provide the cumulative amount that the Department
has recouped from institutions for closed school discharge costs
associated with for-profit colleges since 2014.
Answer. The Department's recoupment of loan discharge liabilities
is a trailing process which follows the Department's quantification of
actual discharged loan amounts and assertion of liabilities. In
general, when an institution closes, it is required to submit a
``Close-Out Audit'' report to the Department. When FSA resolves a
close-out audit, it quantifies closed school loan discharges and
asserts liabilities in the final audit determination for the close-out
audit report. FSA may also pursue additional recovery of liabilities
arising after the close-out audit is resolved. In all cases, the
Department must provide institutions with appeal rights to challenge
asserted liabilities and the Department does not pursue collections
while an appeal is pending. In addition, the circumstances of some
school closures may require the Department to pursue recoveries through
protracted bankruptcy proceedings. To that end, the Department has
recouped more than $10.4 million from institutions for closed school
discharge costs associated with for-profit colleges since 2014.
Question. Please provide the cumulative amount that the Department
has recouped from institutions for borrower defense discharge costs
associated with for-profit colleges since 2014.
Answer. The Department has not recouped any costs associated with
borrower defense discharges from institutions. All approved claims to
date relate to closed schools.
Question. According to the April 2021 borrower defense report, the
Department currently has nearly 108,000 pending borrower defense
claims. Please provide:
The average length of time the 108,000 claims have been pending;
Answer. The average length of time that all applications have been
pending as of June 30, 2021, is 748 days. This is not specific to the
108,000 claims referenced, but rather the total number of pending
applications, which includes those in the Awaiting Adjudication and
Pending Notification categories, as of June 30, 2021.
Question. The percentage of pending claims related to for-profit
institutions (including institutions that have been for-profit
institutions within the past 10 years), public institutions, and
private not-for-profit institutions respectively;
Answer. As of June 30, 2021, 88 percent of total pending
applications were related to for-profit institutions; 4 percent were
related to public institutions; and 8 percent were related to private
not-for-profit institutions. A small number of applications (less than
1 percent) include those without a school assigned and those involving
foreign institutions.
Question. A breakdown of the 108,000 pending claims by institution;
and
Answer. An Excel file providing the requested data as of June 30,
2021, is enclosed. Please note that institutions may appear on the list
several times because the data was pulled based on the institutions' 8-
digit OPEID.
Question. A list of all group discharge applications the Department
has received from State attorneys general including the date submitted,
by whom, the school/programs, and the number of covered borrowers and
the status of each application.
Answer. Information regarding the group discharge requests from
attorneys general is provided in the enclosed file.
Question. How many of the applications referenced in (d) are
pending? How many have been granted? How many have been denied? Please
provide a list of each.
Answer. All of the AG submissions referenced in (d) are currently
under review.
Question. For each of the years 2016, 2017, 2018, 2019, 2020, and
2021 how many borrowers covered by a group discharge application are in
default on their Federal student loans?
Answer. At this time, the Department cannot narrow its reporting to
individual applications submitted by attorneys general. Most of the
attorney general submissions did not specifically identify the
borrowers covered by their group requests, and the Department is
currently working to identify the borrowers at issue.
Question. For each of the years 2016, 2017, 2018, 2019, 2020, and
2021 how many loans of the borrowers covered by a group discharge
application have been certified by the Department of Education for
Treasury offset?
Answer. Please see answer to question 10(f), above.
Question. For each of the years 2016, 2017, 2018, 2019, 2020, and
2021 how many borrowers covered by a group discharge application have
been subject to an administrative wage garnishment order put in place
by the Department?
Answer. Please see answer to question 10(f), above.
Question. For each of the years 2016, 2017, 2018, 2019, 2020, and
2021 what are the total dollar amounts of Federal student loans
(interest and principal) covered by each group discharge application
from a State attorney general?
Answer. Please see answer to question 10(f), above.
Question. For each of the years 2016, 2017, 2018, 2019, 2020, 2021
what are the total dollar amounts collected through the Treasury Offset
Program on defaulted student loans covered by each group discharge
application from a State attorney general?
Answer. Please see answer to question 10(f), above.
Question. In January 2017, State attorneys general--led by
Illinois--provided the Department with program-level enrollment data
for borrowers in their states that were covered by the Department's
Corinthian job placement misrepresentation findings. How many of these
borrowers have still not received relief despite being eligible?
Answer. Due to data limitations, FSA is unable to respond to this
question at this time. While the Illinois Attorney General did provide
a borrower list in December 2016, the list did not contain the unique
identifiers (Social Security Number and/or date of birth) necessary to
confidently match to borrowers in FSA's systems. The Department is now
working to identify any borrowers submitted by the Illinois Attorney
General and any other attorneys general who may be covered by the job
placement rate findings, as that work was not done previously.
Question. 34 CFR 685.300 governs Program Participation Agreements--
the contracts between schools and the Department of Education. CFR
685.300(e) prohibited schools from making or enforcing class action
bans and mandatory pre-dispute arbitration agreements.
Answer. As a preliminary observation, the Program Participation
Agreement (PPA) is primarily governed by 34 C.F.R. Sec. 668.14. 34
C.F.R. Sec. 685.300 provides additional participation requirements when
a school participates in the Direct Loan program. The provisions of 34
C.F.R. Sec. 685.300 are inapplicable if an institution elects not to
participate in the Direct Loan program. The provisions were removed
effective July 1, 2020. Therefore, the response to question a. extends
only to June 30, 2020.
Question. In how many schools' Program Participation Agreements did
the Department include this prohibition?
Answer. From July 21, 2019 and through June 30, 2020, the
Department created and executed Program Participation Agreements (PPAs)
that have included specific language referencing class action bans and
pre-dispute arbitration agreements for 1,155 schools. As of July 29,
2021, 1,070 of these schools were approved to participate in the Direct
Loan program, and 85 schools were not approved to participate in the
Direct Loan program. PPAs created before July 21, 2019, contained
overarching language indicating that schools were required to comply
with all Title IV, Higher Education Act and Direct Loan program
participation requirements, which would extend to the restrictions
relating to class action suits and pre-dispute arbitration agreements.
Question. In how many instances did the Department seek to enforce
this prohibition? What actions did it take?
Answer. The Department does not comment on deliberative,
preliminary, or ongoing investigative work, including the enforcement
of the Title IV regulations. Generally speaking, through our program
review authority, we will monitor compliance with the requirements that
schools end enforcement of any existing mandatory pre-dispute
arbitration clauses and class action restrictions in enrollment
agreements.
Question. Are you aware of any class actions that schools
participating in Title IV forced into arbitration while the prohibition
was in effect?
Answer. The Department is aware of two competing cases that relate
to the prior regulation, which is no longer in effect. The regulation
itself was subject to multiple implementation delays and litigation. In
Kourembanas v. InterCoast Colleges, a class action in the District of
Maine, 17-cv-00331, the court granted a motion to compel arbitration.
And in Young v. Grand Canyon University, the appellate court reversed
the Northern District of Georgia's initial decision to compel
arbitration in Carr et al. v. Grand Canyon University, 19-cv-01707.
Question. Please provide a list of all institutions for which the
Department currently holds a letter of credit or other surety and the
amount of such letter of credit or other surety.
Answer. Enclosed is an Excel file containing data on the Letters of
Credit (LOC) and other surety that the Department held as of July 14,
2021. As of July 14, 2021, the Department held 403 LOCs and other
surety from institutions, totaling more than $607.3 million in
financial protection. The first tab of the Excel file contains
institutional and other data regarding the LOCs held by the Department
as of July 14, 2021. The second tab provides the field definitions and
descriptions of the reasons why a LOC was requested from a listed
institution. Please note that this report differs from reports posted
to FSA's Data Center identifying LOCs requested by the Department
during an Award Year period. It is a ``snapshot'' of LOCs held by the
Department as of July 14, 2021 and it provides the most recent
information recorded in FSA's data sources regarding these LOCs. The
report does not provide historical context for the LOCs held as of July
14, 2021 in cases where FSA may have required an institution to renew
or amend a previously provided LOC. In a limited number of cases, the
report also identifies and includes funds held on deposit by the
Department in lieu of a LOC.
Question. Regarding institutional compliance with the incentive
compensation rules to date, please provide:
The number of program reviews, investigations, audits, or other
reviews that have examined institutional compliance with the
requirements of incentive compensation;
Answer. The Department has issued determinations for 60 program
reviews that were initiated during fiscal years 2017--20 and fiscal
year 2021 through June 30, 2021 that examined institutional compliance
with incentive compensation requirements.
The Department received and finalized its review and audit
resolution process for more than 15,900 compliance audit reports whose
audit period included any portion of fiscal years 2017, 2018, 2019,
2020, or 2021 through July 28, 2021. The compliance audit reports were
prepared either in accordance with the OIG's Guide for Audits of
Proprietary Institutions and For Compliance Attestation Engagements of
Third Party Servicers Administering Title IV Programs, or in accordance
with the OMB Compliance Supplements (2 CFR Part 200, Appendix XI--
Compliance Supplement) for audits reports prepared under the Single
Audit Act. The scope of these audits included audit objectives for an
independent auditor to determine whether the auditees did or did not
comply with the incentive compensation prohibitions.
Additionally, the Department conducted close to 300 ``New School
Visits'' during fiscal years 2017--20 and fiscal year 2021 through July
28, 2021 that reviewed incentive compensation requirements. A New
School Visit is a process focused on the start-up issues and needs of
schools that are new Title IV participants or that might not have
recent Title IV experience. A New School Visit is not a program review,
but rather a tool used to identify and eliminate any weaknesses that,
if left unaddressed, could result in improper use of Federal funds and
possible liabilities for the school. A standard component of a New
School Visit includes a discussion of incentive compensation
requirements, which may lead to the identification of a compliance
deficiency.
Question. how many program reviews, investigations, audits, or
other reviews found;
Answer. The Department has identified 10 instances of incentive
compensation noncompliance in the population of finalized program
reviews, investigations, and other reviews conducted in fiscal years
2017--20 and fiscal year 2021 through July 28, 2020, and finalized
compliance audit resolutions whose audit period included any part of
fiscal years 2017-20 and fiscal year 2021 through July 28, 2021.
Question. Noncompliance with the requirements of incentive
compensation; and the actions the Department has taken to ensure that
institutions correct deficiencies in compliance with the requirements
of incentive compensation
Answer. The Department has issued fine actions totaling $3,411,002
for four institutions in fiscal years 2017--20 and fiscal year 2021
through July 28, 2021.
Question. In recent years, several for-profit colleges have
attempted to convert to not-for-profit status in an effort to avoid the
stigma associated with the predatory for-profit college industry and to
avoid regulations meant to protect students and taxpayers. Dream Center
Education Holdings, which collapsed leaving thousands of students
stranded and whose conversion received preliminary Department approval,
is just one example. Please provide a list of all for-profit
conversions in the last 10 years including those pending (with current
status), previously approved, and denied or withdrawn.
Answer. An Excel file providing the requested information is
enclosed. Within the last 10 years, the Department has received 78
applications for a for-profit to nonprofit conversion. Of those 78
applications, the Department has made final decisions on 40 conversion
requests as of August 1, 2021. Of those 40 decisions, 37 were
approved.\*\ The Department denied Argosy University's request for
nonprofit recognition. The Department also denied Grand Canyon
University's and the American Academy of Art College's requests for
nonprofit recognition when it approved their respective Change in
Ownership applications. Additionally, 18 applications, including pre-
acquisition review applications, were closed due to a voluntary
withdrawal or school closure. There are 19 outstanding conversion
requests, and one pending pre-acquisition application where the Change
in Ownership date is imminent.
---------------------------------------------------------------------------
\*\ In August 2016, the four main locations operated by the Center
for Excellence in Higher Education (CEHE) were originally denied their
conversion request. Following the receipt of additional information and
an updated valuation in October 2018, the Department determined that it
would be appropriate to grant those institutions conditional approval
to convert to nonprofit institutions and issued Provisional Program
Participation Agreements in December 2018. The Department's December
2018 determination of CEHE's nonprofit status--based on the new
information CEHE provided--also provided a basis to dismiss a
longstanding lawsuit filed against the Department, because that was the
relief sought in the lawsuit. Just recently, under pressure from
further reviews of its conduct by FSA, CEHE made the decision to close
its remaining campuses effective Aug. 1, 2021. Additionally, one
approved Change in Ownership transaction involving Kaplan University
and Purdue University resulted in Kaplan University's conversion to
public institution status (rather than to nonprofit institution
status).
Question. Please provide, disaggregated for Corinthian Colleges,
Inc., ITT Educational Services, Inc., Charlotte School of Law,
Education Corporation of America, Vatterott Colleges, and Dream Center
Education Holdings, respectively:
The number of borrowers and the total loan amount of such borrowers
for whom the Department estimates are eligible for the applicable
closed school discharge window (either 120 days or as extended due to
``exceptional circumstances'');
The number of borrowers and the total loan amount of borrowers who
applied for a non-automatic, traditional closed school discharge;
The number of borrowers and the total loan amount that has been
discharged through non-automatic, traditional closed school discharge;
The number of borrowers and the total loan amount that has been
discharged through automatic closed school discharge; and
The number of borrowers and the total loan amount of such borrowers
in some form of debt collection (Treasury offset, wage garnishment,
assigned to PCAs).
Answer. Please find an Excel file with the requested data enclosed.
Question. Your predecessor allowed borrower defense claims to
balloon at the Department without processing any claim for more than a
year. At one time, the backlog had grown to several hundred thousand
claims. As pressure mounted to clear the backlog--of her own creation--
Secretary DeVos issued blanket and cursory denials of tens of thousands
of claims. Many of these are potentially meritorious claims that were
simply cast aside by the previous administration that always looked at
borrower defense as more of a problem to ignore than a mechanism for
justice and fairness. What steps will you take to review the DeVos
Department's borrower defense denials?
Answer. The Department agrees that all borrowers who have filed
borrower defense to repayment applications deserve a thorough and fair
review that is done as expediently as possible. While the Department
continues to approve new categories of borrower defense claims, I have
asked Federal Student Aid to conduct extensive outreach to state
attorneys general, other government agencies, and any other parties
that might be in possession of evidence showing institutional
misconduct. I have also asked FSA to reopen any borrower defense
denials when new evidence, or any other evidence in FSA's possession,
indicates misconduct or other concerns that were not considered during
the initial adjudication. In addition, FSA is conducting a review of
our policies related to borrower defense and will reopen any denied
claims based upon any of those policy changes.
The Department is working diligently to process borrower defense
claims in a timely manner. We are aware of the significant number of
borrowers with a denied claim and are reviewing potential options for
these borrowers.
Question. You recently announced an ambitious higher education
regulatory agenda which will include topics like gainful employment,
for-profit conversions, borrower defense, financial responsibility,
administrative capability. While I'm pleased the Department is
undertaking this process, it is lengthy and the Department's rules
subject to litigation. As it goes through the negotiated rulemaking
process, how will the Department--under your leadership--use its
extensive existing authorities to engage in aggressive oversight and
enforcement activities related to predatory for-profit colleges?
Answer. The Department of Education is working to ensure stronger
oversight of predatory institutions through multiple venues. I expect
that the rulemaking process will help the Department to design far
stronger protections against predatory practices by institutions.
Additionally, the Office of Federal Student Aid is working to ensure
careful oversight of institutions, investigating reports of problematic
practices and increasing monitoring of institutions that receive
Federal aid under Title IV of the Higher Education Act. The new Chief
Operating Officer of FSA, Richard Cordray, is committed to ensuring
consumer protection is embedded in how FSA serves students and
borrowers.
Question. During the Obama Administration, then-Secretary Arne
Duncan created a Federal interagency taskforce to coordinate oversight
and enforcement efforts related to for-profit colleges. The task force
was based on a bill that the late Rep. Elijah Cummings and I wrote
called the Proprietary Education Oversight Coordination Improvement
Act. The task force was successful in coordinating Federal action in
response to misconduct by several for-profit colleges--including a $100
million DeVry settlement with the Federal Trade Commission. Would you
be open to recreating this task force that was disbanded by Secretary
DeVos?
Answer. The Department is deeply interested in strengthening
oversight of misconduct across higher education. The interagency task-
force created by the Obama Administration provided a critical
opportunity for collaboration to identify potential illegal practices
and misrepresentations. The Department is already working to
reestablish those relationships with other Federal agencies through
MOUs and data-sharing agreements, as well as opening the lines of
communication with state Attorneys General, to improve accountability
in higher education.
Question. As part of the American Rescue Plan (Public Law 117-2),
Congress closed the 90/10 loophole which incentivized for-profit
colleges to prey on student veterans and servicemembers. I understand
that the bill prohibited the Department from promulgating regulations
to implement the statutory change before October 2021. In the meantime,
will the Department release Federal 90/10 data which counts accurately
as Federal revenue all revenue received by for-profit colleges from
Federal taxpayer-funded educational assistance programs? This would
include Department of Veterans Affairs GI Bill and Department of
Defense Tuition Assistance funding. While this data could not be used
for enforcement purposes yet, it would be very helpful to the public's
understanding of the problem. In fact, the Department released this
data, upon my request, in December 2016. On December 10, 2018, Chairman
Takano, Senator Carper, Representative Cohen, Ranking Member Murray,
Chairwoman DeLauro, Ranking Member Reed, Chairman Adam Smith, Senator
Blumenthal, Representative Susan Davis, and I wrote to then-Secretary
DeVos asking her to continue this data release. She refused during her
tenure.
Answer. As referenced in your question, section 2013 the American
Rescue Plan Act modifies section 487(a)(24) of the Higher Education Act
of 1965 (HEA) to require a proprietary institution to derive not less
than 10 percent of such institution's revenues from sources other than
``Federal funds that are disbursed or delivered to or on behalf of a
student to be used to attend such institution.'' The Department
unfortunately does not have an updated report covering Federal 90/10
data that counts accurately as Federal revenue all revenue received by
for-profit colleges from Federal taxpayer-funded educational assistance
programs report to release to you. Additionally, the Department does
not maintain the requisite VA, DoD, and other Federal education
benefits program funding data to prepare an updated 90/10 impact
analysis.
The Department wishes to clarify that although it released a 90/10
data report in 2016 covering VA and DoD funds, the Department did not
prepare that report. The Department's 2016 press release indicates DoD
and VA prepared that 90/10 estimate. The Department's December 21,
2016, transmittal letter identifies significant data limitations and
includes a cautionary note against using the data to draw inferences
about individual institutions or trends. The Department's subsequent
March 28, 2019, response to your December 2018 letter reiterated these
themes.
Due to the complexity and individualized nature of the 90/10
evaluation including, but not limited to, a requirement for an
institution to use the cash basis of accounting under section
487(d)(1)(A) of the HEA, an institution's 90/10 compliance is disclosed
in an institution's audited financial statement notes. To perform an
accurate analysis of the impact of the statutory change, an evaluation
must be conducted at the individual student account receivable level
for every recipient of any type of Federal taxpayer-funded educational
assistance program who attended every proprietary school. This type of
analysis is necessary in view of the requirements. The Department has
no confidence that any other analytical approach would yield the
accurate assessment requested.
The Department appreciates your longstanding concern with
institutions receiving Federal education benefits from multiple funding
sources. However, the knowing release of a report that uses
questionable data and depends on unsound assumptions could have harmful
effects in advance of the upcoming rulemaking, including possibly
misinforming and misleading members of the public who may seek to
forecast the anticipated impact of new rules, which may undermine
public trust. The Department is also concerned that the release of an
inaccurate report would violate the Government Accountability Office's
(GAO's) Standards for Internal Control in the Federal Government (GAO-
14-704G), especially Principle 13, ``Use Quality Data.''
Question. Over the last four fiscal years, this Subcommittee--with
the support of Chairman Blunt and Ranking Member Murray--has provided
$24 million to an Open Textbooks Pilot to expand the use of open
textbooks on college campuses to achieve savings for students. While
this program may be small, it has energized students and faculty across
the country who see open textbooks--free, high-quality alternatives to
costly traditional textbooks--as key to reducing student debt and
improving learning outcomes. Many students don't purchase required
course materials because they are too costly. It puts them at an
academic disadvantage and hits low-income, first-generation, and
students of color hardest. So, on a bipartisan basis, Congress created
this program. In early June, the Department made nine new awards with
its fiscal year 2021 appropriation--funding down the slate of fiscal
year 2020 applications. I am pleased that the Department took
Congressional directive and made a great number of awards. In order to
do so though, the Department only funded 1 year of the applicants'
projects. It was my understanding that if the Department took that
step, it would fully fund those nine projects pending the appropriation
of additional funds in fiscal year 2022.
Please confirm that remains the Department's intention.
How is that intention being relayed, with the appropriate caveats,
to the 9 grantees?
Answer. The Department worked extensively with Congress to identify
and implement a funding strategy that would maximize the number of new
awards in fiscal year 2021 that could be awarded with the $7 million in
available funding, ultimately making nine new awards from the fiscal
year 2020 slate. This strategy required a shift from the previous
strategy of frontloading OTP grantees, an approach that fully paid all
multi-year project costs with a single year's appropriation, but which
consequently required making a much smaller number of awards. The
larger number of awards enabled by the shift to incremental funding
allowed roughly twice as many highly rated applicants to launch their
projects in fiscal year 2021 as would have been possible with
frontloading. The Department used approximately $5.9 million to pay
first-year costs and approximately $1.1 million to partially pay down
the second-year costs for the 2021 OTP cohort. We plan to use an
estimated $8.3 million in fiscal year 2022 funds to pay remaining
second- and third-year costs for this cohort, as shown in the fiscal
year 2022 Congressional budget justification for this program.
While the project period for these grantees does not begin until
September 1, 2021, program staff have held post-award calls with the
nine grantees to explain the impact of the change in funding strategies
for the 2021 OTP cohort.
Question. When you came before us, I asked you about the high
percentage of denials under the Public Service Loan Forgiveness (PSLF)
program. You voiced your support for PSLF and your determination that
borrowers receive the forgiveness that they expected and to which they
are entitled. PSLF reform is part of the higher education regulatory
agenda that you have announced. What steps will you take
administratively, outside of formal rulemaking, to help fix the
problems with PSLF?
Answer. As we continue investigating the challenges of PSLF, the
Department is committed to undertaking a serious review of the PSLF
program and to making improvements that will result in better access to
relief for eligible borrowers. In addition to including PSLF on the
regulatory agenda, we recently issued a Request for Information (RFI),
inviting feedback on borrower experiences and possible policy solutions
with the PSLF program, to identify broader areas for improvement. The
Department has already begun to make improvements, including by
launching and updating the PSLF Help Tool, by allowing lump sum and
prepayments to count as qualifying payments, and by creating a single
application for PSLF, Temporary Expanded PSLF (TEPSLF), and Employment
Certification Forms (ECFs). We look forward to making additional
administrative and operational improvements that help eligible
borrowers access the benefits they have earned.
Further, on October 6, 2021, the Department of Education announced
an overhaul of the PSLF Program that it will implement over the next
year to make the program live up to its promise. This policy will
result in 22,000 borrowers who have consolidated loans--including
previously ineligible loans--being immediately eligible for $1.74
billion in forgiveness without the need for further action on their
part. Another 27,000 borrowers could potentially qualify for an
additional $2.82 billion in forgiveness if they certify additional
periods of employment. All told, the Department estimates that over
550,000 borrowers who have previously consolidated will see an increase
in qualifying payments with the average borrower receiving another 2
years of progress toward forgiveness. Many more will also see progress
as borrowers consolidate into the Direct Loan program and apply for
PSLF, and as the Department rolls out other changes in the weeks and
months ahead.
The first major change will result in a limited PSLF waiver that
allows all payments by student borrowers to count toward PSLF,
regardless of loan program or payment plan. This waiver will allow
student borrowers to count all payments made on loans from the Federal
Family Education Loan (FFEL) Program or Perkins Loan Program. It will
also waive restrictions on the type of repayment plan and the
requirement that payments be made in the full amount and on-time for
all borrowers.
Given this new policy, borrowers who currently have FFEL, Perkins,
or other non-Direct Loans, will receive the benefit of this limited
waiver if they apply to consolidate into the Direct Loan program and
submit a PSLF form by October 31, 2022. The waiver applies to loans
taken out by students.
Also, these changes will allow active duty service members to count
deferments and forbearances toward PSLF. This solves a problem for
service members who have paused payments while on active duty but were
not getting credit toward PSLF.
The Department is automatically providing credit toward PSLF for
military service members and Federal employees using Federal data
matches. The Department will implement data matches next year to give
these borrowers credit toward PSLF without an application.
Finally, the Department is reviewing denied PSLF applications for
errors and giving borrowers the ability to have their PSLF
determinations reconsidered. These actions will help identify and
address servicing errors or other issues that have prevented borrowers
from getting the PSLF credit they deserve.
Question. Students' Federal financial aid for higher education is
dependent on their expected family contribution. For many students from
low-income families, their expected family contribution qualifies them
for Federal assistance in the form of a Pell Grant. To confirm accurate
family contributions, some financial aid applications are flagged for
additional verification. Past data from the Department shows that over
half of Pell-eligible applicants were selected for verification in
2015-2016. It is estimated that more than 1 in 5 low-income students
selected for verification never complete the process, thus never end up
receiving Federal financial aid. Students who receive Pell grants have
much higher college retention rates than their peers who are Pell
eligible but do not receive the aid. This data implies it is possible
that the verification process is disproportionately harming the
educational success of low-income students, which is the opposite
intention of the Pell Grant program. The 2017/2018 Award Year ushered
in a new verification model. The Quality Assurance Program ended, which
had given institutions of higher education discretion on application
verification, leaving the Department to select which students needed to
be verified. The risk-model developed by the Department to identify
which FASFA applications needed verification led to a drastically
higher percentage of applications flagged. In fact, some schools
reported that nearly 50 percent of Pell eligible students were selected
for verification multiple times over their course of study even though
their financial information hadn't changed.
Please provide the metrics by which the Department selects which
applications are to be verified.
Answer. Prior to 2018, FSA relied solely on a Classification and
Regression Tree (CART) model to choose FAFSA filers for financial
verification. The CART model used combinations of Targeted Selection
Criteria (TSC) to choose FAFSA filers for verification. In September
2017, FSA funded the creation of an advanced Python-coded machine
learning model (MLM) to improve FSA's verification selection model by
better identifying applicants for whom an error on the FAFSA was more
likely to impact their Expected Family Contribution and, ultimately,
their Federal aid award. FSA has used this model since October 1, 2018.
The MLM updates the criteria used for selection of FAFSA filers for
verification to a gradient boosting classification and regression
model. The metrics the model employs to choose FAFSA filers for
verification include data from the FAFSA, as well as demographic data,
in several complex algorithms. In certain cases, TSC are used to
supplement MLM selection, and a small percentage of applicants are
randomly selected to provide necessary data for model building and
evaluation. As part of this single, overall selection process, a
separate TSC model is used to select applicants for identity/fraud
verification.
Finally, for your awareness, in July we announced some
modifications to our verification approach to the 2021-2022 FAFSA
processing cycle in response to the challenges and barriers resulting
from the ongoing national emergency by focusing solely on identity and
fraud. We continue to evaluate potential approaches for upcoming cycles
to ensure that they are balanced and equitable.
Question. What percentage of students chosen for verification, did
not complete, and failed their verification during the last award year
under model?
Answer. FSA uses the receipt of either a Pell Grant or Subsidized
Direct Loan as a measure of whether an applicant successfully completes
verification once selected. Of those selected for verification during
the 2020-21 FAFSA cycle, 64.5 percent received either a Pell Grant or a
Subsidized Direct Loan. Some students that submit a FAFSA do not enroll
in an institution of higher education for a variety of reasons, so we
would not expect this percentage to equal 100. Therefore, to understand
the impact of the verification process on student enrollment, the
Department compares this rate to the population not chosen for any type
of verification. The rate for those not selected for verification
receiving either a Pell Grant or a Subsidized Direct Loan is 56.8
percent. Please note this data is as of July 28, 2021 and may change
slightly as Award Year 2021 aid is finalized.
Question. We have a student debt crisis that isn't going to resolve
itself. Currently 45 million Americans hold more than $1.7 trillion in
student loan debt. Student debt is larger than credit card debt in our
nation. It is second only to mortgages when it comes to consumer debt.
The average debt per student borrower is more than $37,000. Most of
this is in Federal student loans. The student debt crisis is limiting
young people's life and career choices. Americans are putting off
starting a family and buying a home because of student debt. And it's
not just young people. More than 8 million Americans over age 50 have
student loan debt. For years, I have introduced legislation to fix the
absurd way that the bankruptcy code treats student debt. If a person
overextends himself on his credit card or goes into debt buying a car
or a boat or a luxury watch, he can address those debts in bankruptcy.
But the bankruptcy code provides no meaningful relief for student loan
debt. In 1998, Congress put Federal student loans in the category of
nondischargeable debts, along with alimony, child support, overdue
taxes, and criminal fines. Right now, the only way a student borrower
can get bankruptcy relief for student loans is if she can demonstrate
``undue hardship.'' This standard is not defined in law, and courts
have interpreted it to make it nearly impossible to meet. But,
Secretary Cardona, you have the ability to help this situation. The
Department of Education can set internal standards for when it views an
undue hardship as being met, and can direct its contractors and
servicers not to challenge those undue hardship claims in bankruptcy
court. For years, I have urged previous Secretaries of Education to use
this authority and to issue undue hardship guidance for its guaranty
agencies and contractors. There are categories of debtors where undue
hardship can be presumed--for example, debtors who suffer from certain
disabilities, or who have had a low income for a number of consecutive
years. If the Department would use this authority, it would create an
option of last resort for student debtors who truly have nowhere else
to turn. Will you commit to issue guidance on the Department's views of
when an undue hardship claim can be met?
Answer. The Administration is committed to ensuring that student
loan borrowers have options to make the burden of student loans more
manageable . The consequences of delinquency and default on Federal
student loans can be substantial, particularly for borrowers who are
suffering from other economic hardships, including many who ultimately
file for bankruptcy relief on their debts. We have already taken
initial actions to support borrowers; but we recognize that more work
remains to be done.
To that end, the Department is committed to reviewing its 2015
guidance on undue hardship student loan discharges in bankruptcy
proceedings, as well as other policies related to such proceedings to
assess the types of changes that might better protect borrowers. We
hope to have more to share on this soon.
Question. A recent report by the National Student Loan Defense
Network, entitled ``The Missing Billion,'' highlights the aggressive
tactics the Department uses to collect from struggling borrowers--
including challenging claims of undue hardship in bankruptcy. At the
same time, the report finds that the Department has failed to collect
on more than $1 billion owed to taxpayers by for-profit institutions
and executives. Please comment on the findings of this new report.
Answer. The National Student Loan Defense Network's (NSLDN's)
report, ``The Missing Billion,'' compares the differences in the
Department's collection of liabilities owed by institutions and its
collection of student loans owed by individual borrowers in default.
This difference primarily comes from statutory provisions that make it
difficult to hold individual owners liable for the corporate debts of
the institutions, in contrast to provisions that substantially limit
any bankruptcy relief under an ``undue hardship'' standard. See 11
U.S.C. Sec. 523(a)(8). The ``undue hardship'' standard applies to
educational debts when individuals seek bankruptcy protection. In
seeking to enforce that standard uniformly, the Department considers as
a factor the availability of several student loan repayment plans that
can take a borrower's circumstances into account to reduce a borrower's
scheduled loan installments to a more affordable monthly payment.
The Department uses oversight measures as provided in the
Department's regulations to identify institutions that are financially
weak and institutions with impaired administrative capability. These
measures include monitoring the numeric composite score of financial
responsibility, requiring institutions with failing financial scores to
provide letters of credit (LOCs), using Heightened Cash Monitoring
(HCM) methods of payment, and provisional certification to monitor
schools' compliance with the Department's requirements to mitigate
risk.
Frequently, LOC amounts, HCM requirements, and provisional
certification are linked to an institution's performance under the
Department's financial responsibility requirements and an institution's
numeric composite score determined by financial analysis of the
institution's annual financial statements in accordance with the
Department's regulations. Consistent with the Department's regulations,
LOC amounts are indexed to an institution's annual Title IV, HEA
funding. The proceeds of LOC collections can be applied towards an
institution's unpaid debts after any related appeals are fully
resolved. When the Department perceives increased financial or
administrative risk, the Department may require institutions to comply
with more stringent requirements, such as raising the amount of
financial protection an institution must provide and increasing the
level of scrutiny applied to payment requests through the HCM2 method
of payment. The Department also considers risks associated with
increased compliance requirements. One outcome of stringent enforcement
and oversight can be that an IHE may close if it is unable to fully
comply with more rigorous requirements, such as a posting a larger LOC.
The Department's Office of Finance and Operations collects debts
owed to the Department and follows applicable Federal debt collections
laws, including the Debt Collection Improvement Act of 1996, when
collecting debts and when referring delinquent debts for collections.
If an institution files for bankruptcy, it immediately loses
eligibility to participate in the Title IV, HEA programs. The
Department is bound to follow applicable bankruptcy law and pursues
debt recovery from the institution's estate through the bankruptcy
court. Institutions that close often do so with a lot of debt and
limited assets to be distributed among the creditors. Collection of
liabilities against an institution is generally limited to the direct
owner corporate entity unless there is litigation to ``pierce the
corporate veil,'' which often proves difficult. Litigation to recover
liabilities against individuals can only be brought by the U.S.
Department of Justice and requires piercing the corporate veil in order
to hold individuals personally accountable. The Department has taken
steps to prevent individuals with unpaid school debts or bad track
records running schools from operating other schools. The Department's
past performance regulations can bar school owners who owe unpaid debts
from owning or exercising substantial control over other schools until
their outstanding debts are paid.
We are reviewing the report to determine if there are any
outstanding actions that need to be resolved for currently
participating schools. While the report is critical of the Department's
administration of debts owed by institutions, an initial reading also
indicates the report contains unfounded conclusions and inaccurate
claims because it fails to take into account the requirements to
establish liabilities against institutions. The report also appears to
misinterpret the data provided to NSLDN via the Freedom of Information
Act (FOIA).
As an example, the report is critical of the Department's
administration of debts owed by institutions owned by Zovio, Inc, and
claims the Department failed to collect a $883,613 liability amount
assessed against the University of the Rockies (owned by Zovio, Inc.).
In actuality, the Department's efforts to collect this liability
(arising from a final close-out audit determination) have been
suspended in accordance with 34 C.F.R. Part 668, Subpart H--Appeal
Procedures for Audit Determinations and Program Review Determinations
because an appeal is currently pending resolution with the Department's
Office of Hearings and Appeals. The suspension of collections is
required under the Department's regulations at 34 C.F.R.
Sec. Sec. 668.23(f)(1); (g)(1)(i)-(ii); and 668.123. These regulations
provide that an institution must repay an audit liability within 45
days of the date of the Department's notification, unless the
institution files a timely appeal or unless a longer repayment period
is permitted. A liability may be established but not paid in full
because an institution is repaying the liability owed under a repayment
agreement. The Department monitors institutional compliance with
repayment requirements. Failure to comply with these repayment
requirements is a violation of the Department's financial
responsibility standards, as described above.
The report suggests that Department improperly issued a Program
Participation Agreement to Ashford University (also owned by Zovio,
Inc.) while Ashford owed a $32,965 liability. The Department's Federal
Student Aid office received confirmation on Oct. 5, 2016, that Ashford
University had fully repaid the $32,965 liability to the Department on
Sept. 9, 2016. The Department would not dispute that the $32,965
receivable erroneously included in the records provided to NSDLN
through the FOIA request was the result of a recordkeeping error.
However, before the Department provided a Program Participation
Agreement to Ashford University on Oct. 20, 2017, the Department had
determined that Ashford had fully paid the liability.
As another example, the report states ``The Department has asserted
a $283,782,751 claim in the bankruptcy proceeding against ITT Technical
Institute, plus an additional $1,544,738 against the school due to its
ownership and operation of Daniel Webster College. Yet the Department's
list of unpaid debt only includes approximately $343,000 from ITT and
nothing with respect to Daniel Webster College.'' In this instance, the
Department did not issue final determinations associated with the debts
identified in the proof of claim to avoid violating the automatic stay
provisions of the Bankruptcy Code.
The NSLDN report unfortunately misinforms its readers that ``[t]he
Department's inaction has irrevocably cost at least $218 million
because the statute of limitations on collections has expired'' by
misconstruing 28 U.S.C. Sec. 2462. The NSLDN report cites as support 28
U.S.C. Sec. 2462 and the Lincoln University case (Docket 13-68-SF),
April 25, 2016, in Footnote 35. A reading of 28 U.S.C. Sec. 2462
undermines the notion that there is a statute of limitations on
collections. Rather, 28 U.S.C. Sec. 2462 establishes a statute of
limitations for commencing actions to assess civil fines, etc. which
must be commenced within 5 years from the date when the claim first
accrued. In Lincoln University, the Department asserted on Oct. 25,
2013, fines for Clery Act violations which occurred on Oct. 1, 2006,
and were repeated annually on that date until 2009 under the
Department's regulations at 34 C.F.R. Part 668, Subpart G--Fine,
Limitation, Suspension and Termination Proceedings (Subpart G). The
question was whether the Sec. 2462 statute of limitations for these
violations had elapsed based on the date the violation occurred. After
close review of Sec. 2462, the Subpart G hearing official held in the
initial decision dated March 16, 2015 that the statute of limitations
barred the Department's fines for the 2006, 2007, and 2008 Clery Act
violations, but that the fines for the 2009 violations were not barred.
There is however no discussion in the Lincoln University decisions to
support the assertion that a fine is uncollectable under Sec. 2642
simply because the debt is asserted or continues to exist more than 5
years after the claim first accrued. Indeed, the initial and remand
decisions ordering payment of fines in Lincoln University were dated
more than 5 years after the violation. To assert otherwise implies that
those who are subject to a civil penalty or fine action can evade and
self-discharge their payment obligation after 5 years of making no
payments. Additionally, 28 U.S.C. Sec. 2462 only applies to civil
fines, penalties and forfeitures; it does not apply to repayment
liabilities. Funds owed back to the Title IV program are not subject to
any statute of limitations.
Question. Two decades ago, a CDC study came out that changed the
way we think about public health. It was called the Adverse Childhood
Experiences or ``ACEs'' study and it established the link between
exposure to trauma--things like witnessing violence or an overdose--and
our long-term health, education, and economic outlook. We now
understand how trauma and ACEs harm brain development and how having
multiple of these emotional scars can reduce life expectancy by up to
20 years make you two times less likely to graduate high school and
make you 10 times more likely to attempt suicide. Prior to COVID-19, we
already had an epidemic of gun violence, suicides, and overdoses--all
of which exacerbate and stem from the root issue of trauma. But the
pandemic has magnified this problem, with a recent CDC study finding a
50 percent increase in suicide attempts by teenage girls. Senator
Capito of West Virginia and I teamed up in 2018 to pass legislation to
increase funding and coordination across the Departments of Education
and HHS to promote this understanding of trauma in more Federal grant
programs. Specifically, we authorized a $50 million trauma and mental
health services grant program for schools, which we have not yet been
able to fund. This grant program--Section 7134 of the SUPPORT Act--
would support schools in adopting trauma-informed practices, training
more staff, engaging families, and forging partnerships with clinical
mental health professionals. I know the Biden Administration is
proposing $1 billion to support more counselors in schools--sign me up
for that. Would you also support appropriations for this already
authorized program to address the breadth of trauma needs in schools--
setting up comprehensive plans, trainings, and partnerships, beyond
just adding school psychologists or counselors?
Answer. COVID-19 has had a devastating impact on many families,
contributing to significant trauma resulting from isolation, economic
stress, housing insecurity, and the loss of loved ones, among other
traumatic events. Prior to COVID-19, many of these kinds of traumas and
others already existed and were only further exacerbated by the
pandemic. A significant number of students, predominantly students from
low-income backgrounds, rely on their schools for access to mental
health services and other services that are intended to meet their
physical, social, emotional, and mental health needs. The need for all
students, especially those most underserved, to have access to these
critical services is why the Department requested $1 billion to double
the number of school counselors, nurses, social workers, and school
psychologists over the next decade. It is also why we requested $250
million for IDEA, Part D Personnel Preparation to support the pipeline
into the profession , including mental health service providers, and
their preparation, development, and support. The Department is also
requesting $443 million to support Full Service Community Schools--
schools which have in place the kinds of comprehensive plans and
partnerships you describe to support students and families. We also
call for increased investments in the Promise Neighborhoods, School
Safety National Activities, and Student Support and Academic Enrichment
Grants programs, all in effort to provide a comprehensive set of
investments intended to mitigate the impact of traumatic experiences
and help our students heal from the trauma, develop, and thrive. We
look forward to working with you to make these kinds of critical
investments in existing programs and identify additional opportunities
for targeted and increased investments.
Question. Multiple Congressionally mandated Department of Education
studies of the D.C. Opportunity Scholarship program--the only
federally-funded voucher program--have found that the program does not
improve the academic achievement of students in the program. In fact,
two recent Department of Education studies of the program found that
students using vouchers have performed worse academically than their
peers not in the voucher program. And, previous studies have indicated
that many of the students in the voucher program are less likely to
have access to key services such as ESL programs, learning supports,
special education supports and services, and counselors than students
who are not part of the program. Moreover, a study from the Urban
Institute found that receiving a voucher does not increase D.C.
students' college enrollment rates. Given these troubling findings, do
you support continuing Federal support for the program?
Answer. The Administration seeks to phase out the D.C. Opportunity
Scholarship Program while providing scholarships to students currently
participating in the program through 12th grade. Accordingly, the
Administration has requested level funding for fiscal year 2022 to
continue funding scholarships for continuing students in school year
2022-2023.
______
Questions Submitted by Senator Jack Reed
Question. PSLF and Military Service Members--Earlier this year, the
Government Accountability Office (GAO) issued a report finding that 94
percent of the Public Service Loan Forgiveness (PSLF) applicants in
military service or Department of Defense (DoD) civilian jobs were
denied. Additionally, the GAO recommended that the Department of
Education could take additional steps to improve information sharing
about PSLF with DoD about military service members and DoD civilian
personnel seeking to participate as well with potential beneficiaries.
According to the GAO, as of February 17, 2021, 178,215 active-duty
service members had direct loans eligible for PSLF, and another 16,195
active-duty service members had Federal loans that could be
consolidated into new qualifying direct loans. These statistics offer
just a small snapshot of the full scope of eligible military borrowers
who should be benefiting from the protections of PSLF since borrowers
first became able to secure forgiveness through the program in 2017.
Using the Department of Defense's DMDC website, please provide the
total number of active duty service members (and veterans) with Federal
student loans who have served since PSLF launched on October 1, 2007
and who continue to be in repayment on Director Loans and/or FFELP
loans.
Answer. FSA is working to produce such an analysis, in
collaboration with the Department's Office of the General Counsel and
the Department of Defense.
Question. Please provide information on the Department's efforts to
implement the GAO recommendations. Also please include information
about the Department's plans to use any other authority, such as
authorities under the HEROES Act of 2003, to ease the process and
expand access to PSLF for military service members.
Answer. The Government Accountability Office (GAO) made two
recommendations for the Secretary of Education in its recent report,
``Public Service Loan Forgiveness: DoD and Its Personnel Could Benefit
from Additional Program Information (GAO-21-65).'' The other three
recommendations in the report were addressed to the Department of
Defense (DoD).
First, the GAO recommended that Federal Student Aid (FSA)
collaborate with officials in DoD's Office of the Under Secretary of
Defense for Personnel and Readiness to share information about the
Public Service Loan Forgiveness (PSLF) Program, including current
information on program participation and eligibility, as well as
program requirements. The Department concurred with the recommendation
and has already begun this collaboration with DoD. For example, FSA had
already begun discussions with DoD about enhancements to our digital
toolsets and is actively working with DoD on providing more and
improved information to employees interested in PSLF.
Second, the GAO recommended that FSA update the student loan guide
for service members to provide information on applying for PSLF and
TEPSLF, as well as the steps borrowers can take to count their annual
payment from DoD's student loan repayment program as multiple
qualifying payments for the PSLF program. The Department again
concurred with the recommendation and intends to update the next
version of the student loan guide for service members to reflect the
new combined PSLF form, which no longer requires borrowers to
separately apply for TEPSLF. In addition, FSA currently makes
information available on lump sum payments made by DoD for service
members through StudentAid.gov. We agree this information should be
included in the next version of the student loan guide for service
members. FSA will work with DoD to ensure there are clear instructions
for borrowers participating in DoD's student loan repayment program to
earn qualifying payments for the PSLF Program.
On October 6, 2021, the Department of Education announced a set of
actions that, over the coming months, will restore the promise of PSLF.
We will offer a time-limited waiver so that student borrowers can count
payments from all Federal loan programs or repayment plans toward
forgiveness. This includes loan types and payment plans that were not
previously eligible. We will pursue opportunities to automate PSLF
eligibility, give borrowers a way to get errors corrected, and make it
easier for members of the military to get credit toward forgiveness
while they serve. We will pair these changes with an expanded
communications campaign to make sure affected borrowers learn about
these opportunities and encourage them to apply.
The Department is working hard to eliminate barriers for military
service members to receive PSLF. The Department will allow months spent
on active duty to count toward PSLF, even if the service member's loans
were on a deferment or forbearance rather than in active repayment.
This change addresses one major challenge service members face in
accessing PSLF. Service members on active duty can qualify for student
loan deferments and forbearances that help them through periods in
which service inhibits their ability to make payments. But too often,
members of the military find out that those same deferments or
forbearances granted while they served our country did not count toward
PSLF. This change ensures that members of the military will not need to
focus on their student loans while serving our country. Federal Student
Aid will develop and implement a process to address periods of student
loan deferments and forbearance for active-duty service members and
will update affected borrowers to let them know what they need to do to
take advantage of this change.
Finally, the Department is working to automatically help service
members and other Federal employees access PSLF. Military service
members and other Federal employees devote themselves to serving the
United States, and we should make it as easy as possible for them to
receive PSLF. Next year, the Department will begin automatically giving
Federal employees credit for PSLF by matching Department of Education
data with information held by other Federal agencies about service
members and the Federal workforce. To date, approximately 110,000
Federal employees and 17,000 service members have certified some
employment toward PSLF. These matches will help the Department identify
others who may also be eligible but cannot benefit automatically, like
those with FFEL loans.
Question. Restarting Student Loan Repayment--Payments on Federal
student loans have been paused for over a year due to the pandemic,
with borrowers currently expected to begin repaying their student loans
on October 1 of this year. There are indications that the restart will
trigger unprecedented outreach to servicers, with survey data showing
that servicers could field inquiries from more than 9 million
borrowers. There have been indications that it will take approximately
2-4 months for servicers to rehire, train, and obtain background checks
for their workforce.
As the U.S. Department of Education and its student loan servicers
prepare for the repayment restart, what are the essential steps that
the Department is considering to ensure a seamless return to repayment?
What is the timeframe for implementing these steps so that the Office
of Federal Student Aid and servicers have sufficient time to implement
this plan so that both borrowers and servicers can prepare? What is the
Department's monitoring plan for servicers on their implementation of
the restart of repayment?
Answer. The Department's goal is to achieve a smooth transition
that minimizes borrower harm due to confusion, lack of awareness, and
insufficient servicing capacity. To this end, the Department has
produced a comprehensive plan that combines elements of borrower
outreach, servicer hiring, training and preparation, and vendor and
process oversight to ensure borrowers have the resources they need to
effectively manage the process of returning to repayment.
From an outreach perspective, in March 2020, FSA launched an
ongoing communications and engagement campaign to provide borrowers
clear, concise messaging related to available CARES Act benefits and
the eventual transition to repayment. Since then, FSA has engaged in
continuous communication efforts to encourage student loan borrowers to
take actions to put them on the best repayment plan for their economic
situation before payments resume. From July 2020 until the end of
February 2021, FSA sent over 220 million emails to borrowers,
supplemented by multiple paid media campaigns.
FSA has also posted information on StudentAid.gov to assist
borrowers in preparing for payments to resume, specifically
recommending that borrowers update their contact information with their
loan servicer and in their StudentAid.gov profile, use Loan Simulator
to find a repayment plan that meets their needs and goals, and consider
applying for an income-driven repayment plan. As we approach the end of
the forbearance period, outreach to borrowers will increase and include
broad campaigns aimed at increasing general awareness of payment
resumption and options to address ability to repay, as well as targeted
outreach to at-risk borrowers.
To ensure our servicers are prepared for the restart of repayment,
FSA engaged in ongoing conversations with loan servicers about their
preparations and staffing levels since the CARES Act was passed in
March 2020. During the payment pause, FSA has clearly communicated
expectations for how loan servicers should engage with borrowers. FSA
is continually analyzing historical, current, and projected future loan
servicer staffing levels against several customer service metrics to
ensure servicers are ready for payments to resume. As we prepare for
borrowers to enter repayment, FSA will provide detailed communications
``playbooks'' for loan servicers to follow. To ensure loan servicers
are held accountable for customer service performance during the return
to repayment effort, FSA plans to add explicit return-to-repayment
performance expectations, called service level agreements (SLAs), to
the servicers' existing contracts. Proposed SLAs would focus on call
center performance, such as abandon rates and Average Speed to Answer,
to ensure borrowers have prompt, easy access to information. As
borrowers exit the payment suspension period, FSA will expand our
monitoring to include all aspects of return to repayment. Vendors who
fail to adhere to any statutory, regulatory, or contractual standards
will be held accountable through appropriate corrective actions, which
may include financial penalties.
On Aug. 6, 2021, the Department announced a final extension of the
payment pause until Jan. 31, 2022. The Department is already working
diligently to ensure a smooth transition back to repayment for all
borrowers
The pause on student loan repayment will end on January 31, 2022,
and we are planning around that date. The Department's priority is to
ensure students and borrowers get the service they deserve. We are
committed to ensuring that student loan borrowers are able to
transition smoothly into repayment. The Department has established
timelines with key deadlines related to returning student loans to
repayment. Those plans include substantial communications and outreach
to make borrowers aware of the resumption of loan payment obligations.
FSA also continues to communicate with servicers about return to
repayment as information becomes available. Additionally, the
Department plans to collaborate with Federal and state regulators to
ensure our oversight of Federal student loan servicers is as effective
as possible, and are working to ensure the tools available to the
Office of Federal Student Aid are used to the fullest extent possible.
Question. FFEL and Repayment Relief--In April, Senator Murkowski
and I sent you a letter asking you to address the over 5 million FFEL
and the roughly 1.7 million Perkins loans borrowers who have been left
out of the CARES Act relief and the subsequent extensions of the pause
on student loan repayment.
What steps is the Department taking to ensure that all Federal
student loan borrowers have equal access to any current or proposed new
relief and benefits?
Answer. We have taken steps to assist those FFEL borrowers that
have defaulted during the national emergency. In March 2021, the
Department announced that the payment pause on interest and collections
would be extended to all defaulted FFEL loans, protecting more than
800,000 borrowers from debt collection activity such as wage
garnishment and seizure of tax refunds. FFEL loans on which borrowers
defaulted since March 13, 2020, the start of the national emergency,
are being restored to good standing, and the record of default removed
from their credit reports. The Department continues to explore
additional opportunities to aid all Federal student loan borrowers,
whether they hold FFEL, Perkins, or Direct Loans, and to ensure that
their payments remain affordable, particularly during a period that has
been challenging for so many borrowers.
______
Questions Submitted by Senator Joe Manchin, III
Question. I want to once again thank you for working with myself
and Senator Murkowski on getting out the first tranche of the American
Rescue Plan funding for homeless children and youth in an expedited
manner, so we could ensure that homeless children and youth are
identified and are able to access summer programming and wrap-around
supports they need in light of the COVID-19 Pandemic. In the
Department's initial announcement surrounding this funding, you
indicated that the second tranche of this funding could be available as
soon as June, to help states and school districts prepare for the fall.
This is critical as we expect to see even greater numbers of
homelessness and higher level of service needs, as communities return
to in person learning.
Can you tell me if those plans for the release of the second
tranche of homelessness funding are on schedule, and will be out this
month?
Answer. The awards for the second tranche of American Rescue Plan
funding for homeless students were made on July 27, 2021.
Question. In the final fiscal year 2021 spending package, I was
able to secure language urging the Department to ensure that local
educational agencies (LEA's) set aside adequate amounts of Title I Part
A funds for students experiencing homelessness and use those resources
effectively.
Can you tell me what the Department has done to date to implement
this request and does this budget proposal do anything to implement
that language further?
Answer. In July 2018, the Department sent a letter to State
educational agencies (available at: https://oese.ed.gov/files/2020/02/
letterforessatitleialeahomelesssetaside-1.pdf) that highlights the
requirement that an LEA reserve sufficient funds under Title I, Part A
to provide services for students experiencing homelessness. This
clarification was included in an update in August 2018 to the non-
regulatory guidance for the Education for Homeless Children and Youth
(EHCY) program and it is also part of the monitoring protocol for the
EHCY program. The Department asks the States that it is monitoring to
provide a list of all Title I, Part A set-asides by LEA. These are
compared with the latest available homeless student enrollment counts,
which usually lag by 1 year. The SEA is asked to explain if any LEAs
had homeless students enrolled but did not set aside a reservation from
Title I, Part A to serve them. We also correlate a per-pupil amount to
look for statewide patterns of insufficiency. The EHCY State
Coordinator Handbook developed by the National Center for Homeless
Education (NCHE) has a Summary of EHCY Performance Management Pilot
Monitoring, fiscal year 2015-18 that summarizes which States had
findings or recommendations in this area (Indicator 3.3). For fiscal
year 2022, due to the American Rescue Plan funds for homeless children
and youth, the Department will expand its monitoring of States for
homeless education programs, including the Title I, Part A LEA set-
aside.
In addition, NCHE also provides technical assistance concerning
Title I, Part A requirements for serving students experiencing
homelessness (see https://nche.ed.gov/legislation/title-1-part-a/).
The key proposal in the fiscal year 2022 request that would support
stronger implementation of Title I requirements related to meeting the
needs of homeless students is the additional $20 billion for Title I,
which would more than double funding for Title I districts and schools,
direct more funds to LEAs with the greatest concentrations of poverty,
and help close equity gaps for all students, including homeless
students.
Question. Student loan disclosure forms are essential in helping
students and families understand the costs and terms of their student
loans, but as currently written they are filled with unhelpful legal
jargon, are complicated. lengthy, and don't show the true cost
associated with taking out the loans leading to excess borrowing,
further contributing to the nation's student debt crisis.
What is the Department doing to address this issue and simplify
student loan disclosure forms? Is there anything in this budget
proposal to help with this?
Answer. We are regularly looking at ways to help students,
families, and borrowers better understand and support their efforts to
meet their student loan obligations. For instance, we continue to
promote use of the College Financing Plan, which provides a
standardized financial aid offer letter so students can understand and
compare their options for paying for college. If there are additional
improvements you have in mind, my staff would be grateful to have them
for consideration.
______
Questions Submitted by Senator Roy Blunt
student loan servicing
Question. Mr. Secretary, your budget requests $2.1 billion, which
is an increase of $200 million from the fiscal year 2021 level, to
administer the student aid programs. Yet the budget provides very few
details about how those funds would be used on student loan servicing
activities aside from mentioning a ``long-term servicing solution.''
Can you provide the Subcommittee additional details on your plans for
the long-term servicing solution?
Answer. The Department is currently working on its long-term
servicing plans and looks forward to sharing more information in the
future.
Question. For the last several years the Labor/HHS bill has
included appropriations language requiring the allocation of Federal
student loans to servicers based on the quality of their performance to
encourage the Department to leverage competition among student loan
servicers. The budget request proposes to strike this language because
the requirement will be included in FSA's ``long-term servicing
solution'' despite the fact that no information is included in the
request on what the long-term solution will look like. How will you
continue to hold the Federal student loan servicers to performance-
based allocations as required by years of appropriations laws
regardless of what a future long-term servicing solution may look like?
Answer. The Department currently allocates loan volume based on
servicer performance. We will continue this practice going forward
under the two-year extensions of servicer contracts (as outlined in the
appropriations language), as well as in the future under the final
servicing solution.
Question. The Department has struggled to complete the contracting
process to fully implement its Next Generation Financial Services
Environment. In light of that prolonged struggle, what are your plans
for using the current five Business Process Operations contractors,
which were awarded in June 2020, in the servicing of student loans
moving forward?
Answer. As you are aware, the Consolidated Appropriations Act, 2021
included several provisions related to the future state of loan
servicing, including provisions directly applicable to the Interim
Servicing Solution (ISS) solicitation and Business Process Operations
(BPO) contracts. Specifically, the language prohibited the use of ISS
as a transitional servicing solution and called for an accelerated BPO
implementation that would make it possible for BPO providers to perform
the full suite of loan servicing activities upon migrating accounts to
the ISS platform. After reviewing the change in the solicitation's
requirements as a result of the appropriations provisions, Federal
Student Aid (FSA) decided to cancel the ISS solicitation.
FSA is using this opportunity to work with our new leadership in
the Biden-Harris Administration to refine our long-term strategy for
loan servicing, with the first priority being to ensure student loan
borrowers have a stable, reliable, and accountable solution that meets
their needs. In developing this long-term solution, FSA will continue
to build on the newly modernized systems, tools, and resources for
customers. In particular, FSA expects to leverage the new
StudentAid.gov, the myStudentAid mobile app, and enhanced systems that
allow FSA to improve how we collect and analyze data, offer more self-
service options, provide better customer service, and communicate
directly with students, parents, and borrowers.
In addition, FSA will continue its work to bring BPO vendors online
in preparation for a fall 2021 migration of all non-servicing contact
center work. This work includes taking on FSA's legacy contact center
functions, including the Federal Student Aid Information Center,
Student Loan Support Center, Feedback Center, FSA Ombudsman, borrower
defense hotline, and Office of Inspector General fraud referral. The
BPO vendors will handle much of FSA's direct communication with
customers and partners, including inbound and outbound calls, email,
chat, social media inquiries, and physical correspondence. BPO vendors
will receive training from FSA to ensure they are providing customers
with correct and consistent information and are treating customers and
partners equitably.
The five-month transition to fully onboard the BPOs is expected to
begin in November 2021 and be finalized by April 2022.
career pathways
Question. Programs that provide academic and career counseling and
exposure to postsecondary opportunities to students, as early as 8th
grade and continuing through secondary and postsecondary education,
have been shown to significantly increase rates of postsecondary
enrollment and completion among rural students. To that end, the fiscal
year 2021 Labor/HHS bill included $10 million for the Department of
Education to improve rates of postsecondary enrollment and completion
among rural students through development of career pathways aligned to
high-skill, high-wage, or in-demand industry sectors and occupations in
the region. What is the timeline for publishing a Notice Inviting
Applications for these funds? What can you tell me about how the
Department plans to prioritize and spend this funding this year?
Answer. While the Department is still developing a notice inviting
applications (NIA), we plan to make up to 7 awards to institutions of
higher education and other public and private non-profit organizations
and agencies for 3-year projects that would implement innovative
approaches to improve rates of postsecondary enrollment and completion
among rural students through development of career pathways aligned to
high-skill, high-wage or in-demand industry sectors and occupations in
a specific region.
Question. The budget request proposes a new $1 billion program to
expand career pathways for middle and high school students,
particularly in underserved communities. This Subcommittee will only be
considering the discretionary request, but providing students in high
school or middle school with access to quality work-based learning
opportunities and exposure to their full range of postsecondary college
and career opportunities should be happening in every school. How will
additional funding for CTE help meet that goal?
Answer. Additional funding under both the Career and Technical
Education (CTE) State Grants formula program and CTE National Programs
would support opportunities to provide high school or middle school
students with access to quality work-based learning opportunities and
exposure to postsecondary college and career opportunities, albeit in
different in ways. The reauthorization of the Perkins Act in 2018 added
provisions and requirements pertaining to work-based learning and
including students in middle school in certain CTE activities. However,
States and local grantees have been expected to implement these and
other new requirements with relatively small increases in funding.
After more than a decade of relatively flat funding, the increase in
funding for the program since fiscal year 2019 (the implementation date
for the reauthorized Perkins program) has been approximately 5.7
percent. Increases for this program would provide additional resources
to State and local grantees to implement these provisions.
Increases in funding under CTE National Programs would provide
opportunities to quality work-based learning opportunities and exposure
to support and evaluate targeted activities to provide high school or
middle school students with access to postsecondary college and career
opportunities. Under that program the Department could fund focused,
high quality proposals for such activities and set priorities for
funding, such as funding to high-poverty LEAs and LEAs serving a high
percentage of students of color or a high percentage of students from
low-income backgrounds.
k-12 covid-19 funding/school reopening
Question. Mr. Secretary, you and I both agree it is crucial that we
get kids back in the classroom to prevent further learning loss. While
I'm encouraged to see that more and more schools are reopening for in-
person learning, the latest data from the Department shows that only 51
percent of 4th graders and 41 percent of 8th graders are enrolled in
fully in-person learning and these numbers are even worse for low-
income and minority students. Given the significant amount of COVID-19
emergency funding that has gone to K-12 schools, I would expect these
numbers to be closer to 100 percent. What actions have you taken to
help states and school districts use their ESSER funds to reopen
schools and get kids back in the classroom? Do you expect that all
schools will be fully open for in-person learning this fall?
Answer. We are doing everything possible to support students,
families, teachers, staff, school leaders, and communities to in
returning to full-time, in-person learning this fall, and the
Administration is confident that we, as a nation, will achieve this
goal to the greatest extent possible.
Most recently, on August 2, 2021, the Department released the
``Return to School Roadmap,'' an online resource available at https://
sites.ed.gov/roadmap/to support students, schools, educators, and
communities as they prepare to return to safe, healthy in-person
learning this fall and emerge from the pandemic stronger than before.
The Roadmap includes three ``Landmark'' priorities that schools,
districts, and communities are encouraged to focus on to ensure all
students are set up for success in the 2021-2022 school year: (1)
prioritizing the health and safety of students, staff, and educators,
(2) building school communities and supporting students' social,
emotional, and mental health, and (3) accelerating academic
achievement. The Roadmap also includes planned releases of additional
resources for practitioners and parents on each of these priorities and
will highlight schools and districts that are using innovative
practices to address these priorities. These resources also will
explain how American Rescue Plan funds, including ESSER funds, can be
used to address these priorities in schools and communities across the
country.
The Roadmap is part of the Department's broader efforts to support
schools and districts in the safe and sustained return to in-person
learning since the beginning of the Biden Administration. In addition
to releasing the Roadmap, the Department has issued three volumes of
the COVID-19 Handbook to support K-12 schools and institutions of
higher education in their reopening efforts, prioritized the
vaccination of educators, school staff and child care workers,
published a Safer Schools and Best Practices Clearinghouse, which
includes over 200 examples of schools and communities safely returning
to in-person learning, held a National Safe School Reopening Summit,
provided $122 billion in support through the American Rescue Plan
Elementary and Secondary School Emergency Relief Fund for K-12 schools,
provided over $3 billion in IDEA funds within the American Rescue Plan
to support children and families with disabilities impacted by the
pandemic, awarded $800 million within the American Rescue Plan to
support students experiencing homelessness who have been
disproportionately impacted by the pandemic, released a report on the
disparate impacts of COVID-19 on underserved students, and launched an
Equity Summit Series focused on addressing school and district
inequities that were made worse by the pandemic.
student loan pause
Question. Mr. Secretary, I am concerned that the Administration has
not outlined a plan to transition borrowers back into repayment when
the student loan pause ends this fall. Now that the pandemic is winding
down, it is time for this pause to end. Furthermore, the extension of
the pause beyond what was originally authorized in the CARES Act cost
taxpayers an additional $36 billion. I understand that some borrowers
may still be struggling, but they have access to income-driven
repayment plans where they can pay as little as $0 per month. Will you
commit to end the pause as scheduled at the end of this fiscal year?
Answer. On Aug. 6, 2021, the Department announced a final extension
of the payment pause until Jan. 31, 2022. We believe this additional
time and definitive end date will allow borrowers to plan for the
resumption of payments and reduce the risk of delinquency and defaults
after restart. The Department is already working diligently to ensure a
smooth transition back to repayment for all borrowers
Question. Federal student loan borrowers have gone over a year
without making a payment on their loans. It is absolutely imperative
that the Department begins communicating with borrowers early and often
to ensure that all borrowers understand their responsibilities and
their repayment options when their loans come due on October 1, 2021.
What are your plans to help ensure that borrowers are prepared to
begin repaying their loans when the pause ends?
Answer. In March 2020, FSA launched an ongoing communications and
engagement campaign to provide borrowers clear, concise messaging
related to available CARES Act benefits and the eventual transition to
repayment. Since then, FSA has engaged in continuous communication
efforts to encourage student loan borrowers to take actions to put them
on the best repayment plan for their economic situation before payments
resume. From July 2020 until the end of February 2021, FSA sent over
220 million emails to borrowers, supplemented by multiple paid media
campaigns.
FSA has also posted information on StudentAid.gov to assist
borrowers in preparing for payments to resume, specifically
recommending that borrowers update their contact information with their
loan servicer and in their StudentAid.gov profile, use Loan Simulator
to find a repayment plan that meets their needs and goals, and consider
applying for an income-driven repayment plan. As we approach the end of
the forbearance period, outreach to borrowers will increase and include
broad campaigns aimed at increasing general awareness of payment
resumption and options to address ability to repay, as well as targeted
outreach to at-risk borrowers.
Question. How will the Department engage the Federal student loan
servicers and provide the necessary instructions so that the return to
repayment process goes smoothly?
Answer. FSA has engaged in ongoing conversations with loan
servicers about their preparations and staffing levels since the CARES
Act was passed in March 2020. During the payment pause, FSA has clearly
communicated expectations for how loan servicers should engage with
borrowers. FSA is continually analyzing historical, current, and
projected future loan servicer staffing levels against several customer
service metrics to ensure servicers are ready for payments to resume.
As we prepare for borrowers to enter repayment, FSA will provide
detailed communications ``playbooks'' for loan servicers to follow.
To ensure loan servicers are held accountable for customer service
performance during the return to repayment effort, FSA plans to add
explicit return-to-repayment performance expectations, called service
level agreements (SLAs), to the servicers' existing contracts. Proposed
SLAs would focus on call center performance, such as abandon rates and
Average Speed to Answer, to ensure borrowers have prompt, easy access
to information. As borrowers exit the payment suspension period, FSA
will expand our monitoring to include all aspects of return to
repayment. Vendors who fail to adhere to any statutory, regulatory, or
contractual standards will be held accountable through appropriate
corrective actions, which may include financial penalties.
Question. Both the CARES Act and the December COVID-19
supplemental, as well as the American Rescue Plan, provided a total of
$161 million to FSA to prevent, prepare for, and respond to the COVID-
19 pandemic. How much of this funding has been used and what has it
been used for?
Answer. As of July 30, 2021, approximately $25 million has been
committed and obligated for the following activities: system changes
due to COVID-19; targeted communication campaigns to notify borrowers
of administrative forbearance; increased server capacity and support
for telework; and personnel and compensation for approximately 38 on-
board staff at FSA to support CARES Act related activities.
Question. Does the Department intend to use the remaining funds to
improve communications and outreach with borrowers about the upcoming
end of the repayment pause?
Answer. Yes, the remaining funds will be used to improve
communications and outreach to borrowers, as well as any additional
actions needed to support borrowers regarding the end of the payment
pause.
charter schools
Question. During the last school year, several states saw
significant enrollment shifts into charter schools. For example,
charter schools in California saw an increase of around 2.5 percent
while districts saw a decrease of 3 percent, Colorado saw a 4 percent
increase while districts saw the same decline. New York City charter
schools had an influx of 10,000 students--a 7 percent increase. And yet
the President's budget does not request new funding for the Charter
Schools program. Given the demand we are seeing at the state level, why
isn't the administration requesting more funds for the Charter School
Program?
Answer. The Administration's fiscal year 2022 request would provide
over $210 million for new awards under the various grant components of
the Charter Schools Program. We believe these resources will be
sufficient to meet demand for funding.
Question. The budget proposes prohibiting Charter School Program
funds from being provided to schools that are substantially operated or
managed through a contract with a for-profit entity. However, most
public schools are utilizing the services of for-profit entities in
some way, including for spending their COVID-19 relief funds.
What does ``substantially operated or managed'' mean? Does it
include contracting for services such as payroll and benefits,
staffing, curriculum, professional development, or individual student
services?
Answer. We recognize that public schools, including charter
schools, may contract with for-profit vendors for specific services
that do not constitute management or control of operations and do not
intend to prevent schools engaged in such procurements from accessing
funds under the CSP or other programs.
Question. Why are you proposing this restriction only for charter
schools? Are you considering this requirement for other programs?
Answer. The Administration believes that Charter Schools Program
(CSP) funds should not support charter schools that are operated or
managed by for-profit entities, and we urge Congress to adopt language
that would prohibit CSP funds from supporting schools that are operated
or managed by such entities through contractual relationships. We
believe this is consistent with intent of the program statute, under
which charter school developers or management organizations seeking CSP
funds must be nonprofit.
title i equity grants
Question. The budget request includes $20 billion for a new Title I
Equity grant that proposes to create a new formula not authorized in
statute to force State and local behavior changes related to school
funding systems, teacher compensation, access to advanced curricula,
and access to preschool. There have been a lot of questions and
concerns about this proposal, specifically how funding would be
allocated. Do you have any further details on the impact of this
formula and where the money would be allocated?
Answer. The Administration remains committed to addressing
longstanding concerns around equity in education funding at the
Federal, State, and local levels. However, we also recognize that
further consultation with a wide range of stakeholders, including
Congress, will be necessary to develop a comprehensive set of proposals
aimed at improving education funding equity that can generate broad
support. Consequently, the Administration supports allocating the
proposed $20 billion increase for Title I through the authorized
funding formulas.
Question. Why is the Department proposing to create a new grant
program that interferes with decisionmaking that is best left to State
and local school districts rather than putting additional funding into
programs we know work to increase student achievement, such as the
Charter Schools Program, or further increasing this existing Title I
programs or IDEA, which has long been underfunded?
Answer. The nearly $30 billion, or 41 percent, increase for the
Department of Education proposed by President Biden for fiscal year
2022 provides strong support for Federal education programs across the
board, including a $3 billion or 21 percent increase for IDEA State
formula grant programs. However, because nearly all Federal education
programs provide supplemental funding, the impact and effectiveness of
that funding depends in large part on a level playing field in terms of
the overall education resources made available at the State and local
levels. For this reason, the Administration strongly believes that a
key goal of any major new Federal investment in education should be to
leverage significant improvement in equity for all students, but
especially for students from low-income families and students of color.
In this context, the Administration is working closely with Congress
and stakeholders to leverage additional investments in Title I to
improve education funding equity, support high-quality preschool,
address teacher compensation, and enhance rigorous coursework in Title
I schools. In that context, the Department believes the proposed $20
billion increase for Title I would provide a meaningful incentive for
systemic changes in the equity of our decentralized education system.
naep funding
Question. NAEP provides crucial information about what our nation's
students know and can do in various subject areas. Ensuring we continue
to have this information is more important than ever given the
widespread learning loss that is expected as a result of the pandemic.
Your budget requests an additional $15 million for NAEP in fiscal year
2022. Will this increase ensure that the planned assessment schedule
can remain on track?
Answer. The $15 million proposed for fiscal year 2022, if sustained
in future years, would support operational funding needs, including
planned assessments, through 2024.
mental health
Question. Mr. Secretary, one of my priorities in the Senate has
been mental health--and ensuring that a person's mental health is
treated the same as their physical health. The Department's budget
requests $1 billion for a new program to increase the number of health
professionals in our public schools, including school counselors,
nurses, school psychologists, and social workers. I share your concern
about the well-being and mental health of our nation's students,
particularly given the widespread disruption to school that students
have experienced over the past year due to the COVID-19 pandemic.
However, states and school districts have yet to spend the vast
majority of COVID-19 funding provided to them, and one of the ways they
can spend this money is to provide mental health services to students.
What has the Department done to help states and school districts use
their COVID-19 funding to support the mental health of their students?
Answer. The Administration has recognized from the beginning of its
response to the pandemic that students need a strong social and
emotional foundation to excel academically. It is clear that many
students, and especially students from low-income backgrounds and
students of color, have suffered much over the past 18 months and
require additional support to help them heal and recover from all the
trauma and hardship the pandemic has brought. And we know for many
students, schools are the only place where they can access mental
health professionals, school counselors, nurses, and support structures
they need--including their friends--to help them through the adversity
of the last year. This is why we have emphasized meeting students'
mental health needs as part of our overall effort to reopen schools for
fully in-person learning, including through the hiring of school-based
health professionals as well as other efforts to address social and
emotional development needs.
For example, the Department published Volume 2 of the ED COVID-19
Handbook: Roadmap to Reopening Safely and Meeting All Students' Needs
(see https://www2.ed.gov/documents/coronavirus/reopening-2.pdf), in
April, 2021, which includes a section on Supporting Student Mental
Health Needs that highlights examples and best practices that States
and school districts can implement using funds provided by the American
Rescue Plan. Additional guidance is provided in our ESSER Fund
Frequently Asked Questions document (see Question C-14 at https://
oese.ed.gov/files/2021/05/
ESSER.GEER--.FAQs_5.26.21_745AM_FINALb0cd6833f6f46e03ba2
d97d30aff953260028045f9ef3b18ea602db4b32b1d99.pdf).
We have seen the results of these efforts in the plans that States
have developed for using ARP ESSER funds. For example, Nevada is
reserving ARP funds to hire 100 school-based mental health
professionals and Alaska is using ARP funds to help social workers
provide virtual lessons in self?care and methods to reduce student
stress, depression, and anxiety. The New York City Department of
Education is using ARP funding to hire over 600 mental health
professionals to provide care as students returned back this fall. This
means that every school will have at least one full-time social worker
or school-based mental health clinic.
In addition, we plan to issue guidance on using ARP funs to address
student mental health needs in fall 2021.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. The Institute of Education Sciences (IES) funds education
research, data collection and analysis, and a national assessment of
student progress. The fiscal year 2016 Omnibus included a $44 million
(8 percent) increase for IES. The budget request includes a further $76
million (12 percent) increase. The Investing in Innovation (i3) grant
program required that at least 20 percent of recipients be located in
rural areas. The i3 competition has been replaced with a new grant
program, the Education Innovation and Research program, in fiscal year
2017. Geographic diversity in all research grant programs is important.
From 2013 to 2015 the Department made almost 1,900 grants to
institutions of higher education and other research organizations.
However, those grants went to colleges, universities, and research
organizations in only 35 states. Not one went to a school or
organization in Mississippi and generally the same schools and
organizations tend to get the bulk of research grants year after year.
In my state, 92 percent of school districts and more 50 percent of
students are rural, yet most research is conducted in urban and
suburban communities. The Every Student Succeeds Act requires that
schools implement evidence-based strategies to improve student outcomes
yet most education research is conducted in urban and suburban
settings.
How will you ensure that education research addresses the unique
needs of rural districts?
Answer. Supporting education research to help understand and
address the unique needs of rural districts is a priority for IES. We
support education research, including on rural education, primarily
through two funding mechanisms: (1) field-initiated research grants,
and (2) research conducted by the Regional Educational Laboratories. We
discuss the role of each below.
Research Grants. As a scientific agency, funding decisions are
based on peer reviewer's independent assessments of the scientific
merit of applications, including the significance of the proposed
research project, the scientific quality of the research plan, the
skills of the personnel, and the resources available to support the
proposed project. We hold competitions on various topics to ensure that
the education research that we fund meets the needs of the diverse
populations and geographic settings of our nation.
For example, in 2021, IES launched a new research competition
inviting State agencies to apply for funds to expand use of their State
Longitudinal Data Systems (SLDS) for generating evidence in support of
education policy decisions. Using SLDS as a data source ensures that
all districts within a State can be included in their research
activities. Of the 7 awards made, 5 are made to States with substantial
rural populations, including Tennessee, Montana, Virginia,
Pennsylvania, and Oregon. Mississippi received $6.6 million in 2016 for
an NCES SLDS grant that ended 9/30/20 to enhance its SLDS system, so we
encourage the State education agency to apply for funding under this
program for projects using data from its SLDS for research on rural
populations, and to reach out to IES program officers for input as they
prepare their application.
In addition, IES invested $20 million in two five-year research and
development centers focused on the needs of rural education in 2019:
The National Center for Rural Education Research Networks (NCRERN) and
The National Center for Rural School Mental Health (NCRSMH): Enhancing
the Capacity of Rural Schools to Identify, Prevent, and Intervene in
Youth Mental Health Concerns. Rural districts participating in the work
of these two centers are located in: New York, Ohio, Iowa, New Mexico,
Wyoming, Missouri, Virginia, and Montana. Both rural centers are
actively engaged with communities in these States and beyond and are
developing and sharing resources for the rural education community. For
example, NCRSMH has developed an Early Identification System (EIS)
Intervention Hub (https://www.ruralsmh.com/intervention-hub/) designed
to connect rural educators to resources focused on preventing and
remediating student mental health challenges.
In addition, 27 of our new fiscal year 2021 research awards and 16
of our fiscal year 2020 research awards are being carried out in rural
settings. These studies are addressing teacher retention in rural
schools, fostering positive family-school involvement for students from
economically disadvantaged households in rural communities,
interventions to help special educators with behavior management, and
web-based professional development to help teachers improve students,
reading comprehension in rural districts.
The Regional Educational Laboratories (RELs). For more than 50
years, the REL program has worked in partnership with State, district,
and college and university leaders to develop and use research that
improves academic outcomes for students and their communities. REL
Southeast serves has successfully completed a number of projects
focused on the needs of rural communities in Mississippi, including:
--The Improving Schools in Mississippi Research Alliance, a
professional learning community that supports research and
practice on rural school improvement. Partners include district
leadership from the Vicksburg/Warren Public Schools, Durant
Public Schools, Yazoo City Public Schools, Holmes County Public
Schools, and Humphreys County Public Schools, as well as Alcorn
State University and Mississippi Valley State University.
--The Southeast School Readiness Research Alliance, which seeks to
build the capacity of preschool teachers and administrators
across Mississippi and the other five States in the Southeast
region to use evidence-based emergent literacy instruction to
support three-to five-year old children's language and literacy
learning and to help policymakers understand the factors that
influence access to high-quality childcare and preschool
programs.
--Examining School-level Reading and Math Proficiency Trends and
Changes in Achievement Gaps for Grades 3-8 in Florida,
Mississippi, and North Carolina, which detailed student
achievement trajectories for Mississippi students overall and
within student group, supporting stakeholders decisionmaking
about how to prioritize school improvement efforts.
--Educator Outcomes Associated with Implementation of Mississippi's
K-3 Early Literacy Professional Development Initiative, which
examined changes in teacher knowledge of early literacy skills
and ratings of quality of early literacy skills instruction,
student engagement during early literacy skills instruction,
and teaching competencies.
--Beating the Odds in Mississippi: Identifying Schools Exceeding
Achievement Expectations, which identified K-12 schools that
were performing better than would have been predicted and was
used to inform decisionmaking on statewide school improvement
efforts.
--Math Course Sequences in Grades 6-11 and Math Achievement in
Mississippi, which examined the relationship between students'
course-taking patterns in middle- and high-school and their
subsequent performance on college admission tests, supporting
local and State college readiness efforts.
Question. In awarding research grants, how will you ensure that the
Department considers the geographic distribution of research projects
and geographic disparities in education research funding? How will you
ensure funding is going to colleges, universities, and research
institutions in under-researched and underserved areas?
Answer. IES is required by law, under the Education Sciences Reform
Act, to base our funding decisions on the independently assessed
scientific merit of applications. In all of our grant competitions, we
explicitly seek to broaden participation in our research studies and to
expand the populations and geographic settings within which our studies
are taking place. We are currently supporting a research project at the
University of Southern Mississippi (grant award R305A200185) and two
projects that are collaborations between Arizona State University and
Mississippi State University (grant awards R305A180261 and
R305A180144). IES also periodically holds competitions with a specific
focus on addressing the unique needs of rural America, such as the two
R&D Centers on rural education awarded in 2019. It is important to
stress that these are competitive grant programs which are funded based
on the scientific merit of the applications submitted. We do not
include the State or geographic region in which the applicant
institution is located in the selection criteria for our education or
special education research grant programs.
We also actively seek to broaden participation in our applicant
pool through our research training programs. For example, our Pathways
to the Education Science Research Training program was established to
develop a pipeline of talented education researchers who bring fresh
ideas, approaches, and perspectives to addressing the issues and
challenges faced by the nation's diverse students and schools. These
grants are awarded to minority-serving institutions (MSIs) and their
partners. In the initial two rounds of competitions, IES made awards to
7 institutions and their partners. IES is currently accepting
applications for a new program: Early Career Mentoring Program for
Faculty at Minority Serving Institutions that seeks to prepare faculty
at MSIs to conduct high-quality education research that advances
knowledge within the field of education sciences and addresses issues
important to education policymakers and practitioners.
Question. President Biden's campaign included a Plan for Rural
America. That plan opened with the statement ``Rural America is home to
roughly 20 percent of Americans, but we are all connected to rural
communities in many ways. Rural Americans fuel us and feed us. Rural
lands provide us with places to spend time outdoors with friends and
family and relax.'' This statement suggests an attitude that rural
people and places exist to provide for and serve more populated urban
and suburban areas. The current version of the plan, available here
https://joebiden.com/rural-plan/contains some of the same language but
has been revised. It will be important that the administration move
beyond metro-centric policy making to ensure rural schools are treated
equitably.
How will you ensure that policies and practices in the Department
recognize and value the strengths and unique contexts of rural schools
and communities?
Answer. The Department is committed to educational opportunity and
academic achievement for all students throughout the nation, including
those in rural areas. Our Rural Education Achievement Program, for
example, recognizes the need of many rural school districts for
additional funding, as well as flexibility around the use of Federal
education funds, to address their unique circumstances. Similarly, many
of our discretionary (competitive) grant programs include rural set-
asides to ensure that rural applicants receive an equitable share of
grant funds, and we also use grant priorities for rural and new
applicants that help level the playing field and ensure that rural
applicants can compete successfully for Federal funds.
Question. In 2018, the Department released the Section 5005 Report
on Rural Education in response to a provision in the Every Student
Succeeds Act that called on the Department to critically examine its
policies and procedures in related to rural education. The 2018 report
touted some things the Department is doing to ensure the needs of rural
schools and students are met, and also listed steps the Department
intended to implement to address the needs of rural schools. To date,
not all of those seven steps have been accomplished, most notably, NCES
has not updated its 2007 report on the status of rural education. In
2019 this analysis by Devon Brenner (of MSU) of the Section 5005 report
summarized the reports findings and plans or implementation and
critiqued the report, saying ``it falls short of the 5005 mandate to
self-assess and determine actions to be taken. The Department engaged
in listening sessions and sought feedback from rural stakeholders, but
does not seem to have incorporated feedback from key stakeholder
organizations (e.g., AASA and Rural School and Community Trust, The
University Council for Educational Administration (UCEA), the National
Indian Education Association (NIEA), and the National Association of
federally Impacted Schools). The Department commits to increasing
listening sessions and improving communication but is not clear that
rural input is or will be ``baked into'' the system to ensure that
rural communities are considered in every facet of the Department's
work, particularly rulemaking.'' See https://
journals.library.msstate.edu/index.php/ruraled/article/view/535/501.
How will you ensure that the Department completes these commitments
to improve policies and procedures for rural schools and considers the
needs of rural schools in the development of regulations and the
implementation of programs?
Answer. The Department is committed to ensuring educational
opportunity for all students, including those in rural areas, and
recognizes the need to account for all education settings when
developing policies and procedures.
To that end, in recent years, the Department's Rural Interagency
Working Group has helped offices responsible for our programs,
including the Rural Education Achievement Program (REAP), collaborate
on issues such as access to broadband services which disproportionately
impacts rural schools and communities. Department staff are examining
how we can build upon these internal collaborations. Drawing on the
experience of other Federal agencies, the Department also plans to
collaborate more closely with the Departments of Agriculture, Interior,
and Health and Human Services to better support and serve students in
rural communities.
The Department interacts regularly with REAP grantees and
organizations advancing the interests of rural schools. The Department
appreciates input from rural stakeholders and is working toward being
responsive to that feedback. For example, in order to reduce burden on
rural local educational agencies (LEAs), the Department has simplified
the application process for the Small, Rural School Achievement (SRSA)
grant, under which OESE awards over 4,000 LEA grants annually. OESE
plans to increase its outreach to REAP grantees and its participation
in events organized by rural advocacy organizations such as the
National Rural Education Association (NREA). Additionally, the
Department has recently been in contact with the Organizations
Concerned about Rural Education (OCRE) regarding issues affecting rural
schools and communities and emphasizing collaborative efforts to
support rural schools.
The Department will continue to rely on local leaders and rural
stakeholders for their expertise and knowledge of rural schools, with
those conversations informing plans to support student achievement in
all settings.
Question. Across the nation, equitable access to effective teachers
remains an issue. Rural schools, especially, often struggle to recruit
and retain talented teachers and school leaders. Previous programs such
as the Transition-to-Teaching grant program provided for scholarships
for teacher preparation programs to meet the needs of schools with
demonstrated teacher shortages. In Mississippi, Transition-to-Teaching
grants awarded in the last decade led to the successful licensure of
hundreds of new teachers in the past 5 years, addressing the needs of
rural schools.
Please discuss how you envision the that the Department can
explicitly addresses inequitable distribution of effective teachers,
particularly in rural areas.
Answer. The Administration's fiscal year 2022 request provides both
flexible ESEA formula grant funding and competitive opportunities that
can help States and school districts carry out strategies aimed at
putting effective teachers in front of every classroom:
--The $20 billion increase proposed for the Title I program would
more than double the formula grant funding available to help
address under-resourced school districts while helping to
ensure that teachers in Title I schools, including thousands of
rural Title I schools, are paid competitively.
--The $2.1 billion requested for Title II will support ongoing State
and local efforts to improve teacher and principal
effectiveness and help ensure that all students have equitable
access to well-prepared, qualified, and effective teachers and
principals. In particular, States may use Title II-A funds for
programs that provide alternative routes for State
certification of teachers in areas where the State experiences
a shortage of educators, similar to the previously authorized
Transition to Teaching program.
--The $250 million request for IDEA Personnel Preparation, an
increase of nearly $160 million, would help ensure that there
are adequate numbers of personnel in underserved rural schools
with the skills and knowledge necessary to help children with
disabilities succeed educationally, including enhanced support
for beginning special educators.
--The $80 million requested for Supporting Effective Educator
Development (SEED) would support evidence-based educator
preparation and development efforts that can serve as models
for similar efforts across the country; new projects could have
a stronger focus on building and enhancing the instructional
skills of a more diverse educator workforce.
--The $200 million requested for Teacher and School Leader (TSL)
Incentive grants would support reforms to human capital
management systems and performance-based compensation systems;
the statue requires that priority be given to applicants that
support teacher and leaders in high-need schools; in addition,
consideration is given to ensuring an equitable geographic
distribution of grants, including equitable distribution
between urban and rural areas.
--The $30 million requested for first-time funding (since
reauthorization) of the School Leader Recruitment and Support
program would support grants for high-quality professional
development for principals, other school leaders, and aspiring
principals and school leaders. Under the first competition for
the program since the reauthorization of the ESEA, projects
would focus on ensuring that the nation's most underserved
schools have resources to improve school leadership.
--The $132.1 million request for the Teacher Quality Partnership
program, an increase of $80 million, supports projects that
improve the preparation of teachers, including through teacher
residencies and ``grow your own'' programs that can be
especially valuable in rural communities.
--The $20 million request for first-time funding of the Hawkins
Centers of Excellence program would support diversifying the
educator workforce, including in rural areas, by increasing the
number of high-quality teacher preparation programs at Minority
Serving Institutions.
Question. Rurally located and rural serving public colleges and
universities have an important role to play in the economic and social
recovery from the COVID-19 pandemic. Public institutions of higher
learning are important economic anchors in their communities and
provide important access to educational opportunities that drives rural
economies. However, rural colleges and universities are often
underfunded compared to more urban and suburban institutions of higher
learning, and students face particular challenges including geographic
access and access to broadband Internet and technology. This report on
the role that rural serving institutions play and Federal policy
solutions to strengthen rural anchor institutions https://
www.regionalcolleges.org/project/ruralanchor.
How will you work to enact policies and practices that strengthen
rural serving and rurally located public colleges and universities,
including HBCUs and other minority serving institutions, and the
communities they serve?
Answer. The Department, in general, provides funding to
institutions of higher education (IHEs) through two primary vehicles:
(1) formula-based institutional capacity-building grants, and (2)
discretionary competitive grants. For the Department's formula-based
institutional capacity-building grants, such as HBCUs, HBGI, PBIs, and
HBCU Masters, the Department has little flexibility given statutory
requirements to provide additional funding to rural IHEs. For
discretionary competitive grants, unless specifically prohibited by
statute, the Department generally can give priority to particular types
of institutions.
More broadly, rural-serving postsecondary institutions, include
HBCUs, would benefit significantly from key mandatory programs proposed
as part of the American Families Plan and now included in the Building
Back Better Act. These include Free Community College, which would
provide $108.5 billion over 10 years to create a new partnership with
States, territories, and Tribes to make 2 years of community college
free for first-time students and workers wanting to reskill,
potentially allowing up to 5.5 million students to pay zero in tuition
and fees for 2 years of community college; the Advancing Affordability
for Students program, which would award $39 billion over 10 years for
eligible 4-year HBCUs, TCUs, or MSIs to provide 2 years of subsidized
tuition for students from families earning less than $125,000; and
Completion Grants, which would provide $62 billion over 10 years for
grants to States and Tribes to support completion and retention
activities designed to ensure postsecondary success for low-income and
underserved students in high-need institutions.
______
Questions Submitted by Senator Patrick J. Leahy
Question. Even before the COVID-19 pandemic, Vermont was facing a
mental health crisis in its schools. Many students have been
irrevocably impacted by the opioid epidemic, losing parents and
caregivers. This trauma has had a negative impact on their mental and
behavioral health, leaving many teachers and school staff struggling to
deal with the consequences. This is why I am so pleased to see the new
$1 billion fund proposed by the administration to help schools hire
more counselors, nurses, and mental health professionals.
Unfortunately, Vermont is plagued with a severe shortage not only of
teachers but of mental health professionals. As of May 2021, there were
780 staffing vacancies among our mental health agencies in the state.
The number of kids seeking inpatient mental healthcare in Vermont
tripled between 2010 and 2019, as a dearth of community-based resources
has led many families no choice but to turn to the Emergency Room as a
last resort.
How does the administration propose to help schools, particularly
schools in rural areas, utilize this fund to hire school based health
staff in areas where there are community, or even statewide, shortages
of mental health professionals?
Answer. The School-Based Health Professionals proposal recognizes
the challenges to hiring such professionals in areas facing shortages,
and would allow State educational agencies to reserve up to 15 percent
of their allocations to address shortages of health professionals by
establishing partnerships with institutions of higher education to
recruit, prepare, and place graduate students in school-based health
fields in high-need LEAs and to complete required field work, credit
hours, internships, or related training as applicable for the degree,
license, or credential program of each health-based candidate. SEAs
also may use a portion of these funds for review and revision of State
licensure standards to promote mobility of health professionals into
school settings.We look forward to working with both chambers to ensure
this proposal provides adequate support for both hiring these key-staff
and developing the pipeline.
Question. I strongly support the administration's goal to increase
equity in public education funding. The COVID-19 pandemic has
particularly laid bare the systemic inequalities that exist in our
nation's schools. Vermont has many small and rural schools that have
historically struggled to close both the equity gap and the digital
divide due to a lack of resources. The proposed $20 billion for a new
Title I equity grant program would represent the most significant
Federal investment the program has ever seen. It is vital that this
grant program is an option for all schools that need it around the
country.
How will you ensure that these equity grants are distributed among
geographically diverse areas, particularly rural areas?
Answer. State educational agencies would allocate funds to school
districts based on existing Title I formulas, ensuring that virtually
all school districts--urban, suburban, and rural--receive significantly
more Title I funding to help close equity gaps in teacher compensation,
access to rigorous coursework, and access to preschool.
Question. TRIO and GEAR UP are vital student assistance programs
that helps first generation, disabled and low income college students
in Vermont succeed in all aspects of college life. These programs have
proven effective in increasing postsecondary enrollment and graduation
rates, as well as helping to address workforce shortages in the state.
Unfortunately, both the COVID-19 pandemic and a historical lack of
Federal funding for the programs has meant that many of the grant
application cycles have become highly competitive. For example, the
fiscal year 2020 TRIO Student Support Services (SSS) competition faced
a significant increase in applicants. Separated by mere percentage
points, 80 longstanding SSS programs were defunded, among more than 600
un-funded applicants. This left nearly 15,000 high-need students
without access to services provided by the program.
How does the administration propose to allocate the increase in
fiscal year 2022 funding for TRIO and GEAR UP? Will any of the funding
become eligible to programs that were defunded in the fiscal year 2020
SSS cycle?
Answer. The Administration recognizes that limited resources under
the TRIO and GEAR UP programs have historically resulted in an
inability to fund all high-scoring applicants. This is why the
increased funding proposed for TRIO in fiscal year 2022 would be
allocated, in part, based on historical trends in the programs
scheduled for competition in fiscal year 2022. Specifically, the
Administration reviewed peer review scores on all applications
submitted for fiscal year 2017 competitions under Upward Bound, Upward
Bound Math and Science, Veterans Upward Bound, and McNair
Postbaccalaureate programs (the last year in which competitions were
held under these programs also scheduled for competition in fiscal year
2022), and proposed to allocate additional funds to each program based
on the number of high-scoring unfunded applicants from that year to
ensure that funding more appropriately met demand. In addition, the
Administration has proposed to provide all grantees under the Student
Support Services program a 10 percent supplemental award to support the
critical services they provide our students. However, at this time
there are no plans to make additional Student Support Services awards
to applicants that were unsuccessful in the fiscal year 2020
competition.
Question. The Public Service Loan Forgiveness (PSLF) Program
forgives Federal student loan debt of borrowers who work for at least
10 years in qualifying public service employment. The program has been
plagued by complicated eligibility criteria and ongoing administrative
problems that have resulted in a dismal approval rate. I was pleased to
see the administration recently announce a regulatory review of PSLF
and other Federal student loan relief programs to understand how they
can better serve the needs of our nation's borrowers. However, the
President's Budget proposes a decrease in funding for PSLF.
Could you explain the justification for a 50 percent budget
decrease for PSLF? What progress has the agency made in addressing the
issues that have resulted in such a low approval rate for loan
forgiveness?
Answer. The Department recognizes that there are PSLF areas for
improvement and we are committed to addressing them as quickly as
possible so that our public servants receive the benefits they have
worked hard to earn. We have already made some improvements to make it
easier for eligible borrowers to access relief through administrative
actions and others are in store. For instance, the Department has
launched and updated the PSLF Help Tool, is now allowing lump sum and
prepayments to count as qualifying payments, and created a single
application for PSLF, Temporary Expanded PSLF (TEPSLF), and Employment
Certification Forms (ECFs). However, we recognize more needs to be
done. To that end, we recently announced that PSLF is among the topics
we intend to revisit through an upcoming rulemaking process. We also
recently issued a Request for Information, inviting feedback on
borrower experiences and possibly policy solutions with the PSLF
program, to identify broader areas for improvement.
At the same time, Congress has provided funds annually toward
TEPSLF so borrowers who may have made payments in a repayment plan not
previously eligible for PSLF could still qualify for relief. Though
these funds have remained largely unspent to-date, the Department still
requested additional funds for fiscal year 2022 in recognition of the
importance of this program to public servants. The additional $25
million the Administration requested will ensure even more borrowers
can access the program and receive relief under the TEPSLF program. In
addition to those funds, we are also working to improve administration
of the TEPSLF program and streamline access to its benefits; we believe
those improvements will lead to these funds being more easily awarded
to borrowers in the future.
SUBCOMMITTEE RECESS
Senator Murray. With that, this hearing is adjourned.
[Whereupon, at 11:31 a.m., Wednesday, June 16, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2022
----------
WEDNESDAY, JULY 14, 2021
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10 a.m. in room SD-138, Dirksen
Senate Office Building, Hon. Patty Murray (chairwoman)
presiding.
Present: Senators Murray, Reed, Shaheen, Merkley, Baldwin,
Blunt, Kennedy, and Braun.
DEPARTMENT OF LABOR
Office of the Secretary
STATEMENT OF HON. MARTIN J. WALSH, SECRETARY OF LABOR
OPENING STATEMENT OF SENATOR PATTY MURRAY
Senator Murray. Good morning. The Senate Appropriations
Subcommittee on Labor, Health and Human Services, Education,
and Related Agencies will come to order.
Today we are having a hearing on the Biden administration's
fiscal year 2022 budget request for the Department of Labor.
Senator Blunt and I will each have an opening statement. Then I
will introduce our witness, Secretary Walsh.
After his testimony, Senators will each have 5 minutes for
a round of questions. While we are unable to have this hearing
fully open to the public, or media for in-person attendance,
live video is available on our committee website. And if you
need accommodations, including closed captioning, you can reach
out to the Committee of the Office of Congressional
Accessibility Services.
VISION OF THE FISCAL YEAR 2022 PRESIDENT'S BUDGET
You know, a budget is a reflection of values and through
our hearings on President Biden's budget for the Department of
Health and Human Services, and the Department of Education, we
have seen a welcome change in values from the previous
administration, and the budget proposal for the Department of
Labor is no exception.
This budget is a message to workers across the country;
President Biden is fighting for you. Workers are the backbone
of our economy. When we invest in workers, in keeping them
safe, strengthening their rights, providing pathways for their
development, ensuring their financial security, and more, we
are investing in a stronger economy and a country for everyone.
And that is exactly what this budget, which proposes
increasing funding for the Department of Labor by 14 percent,
does. When it comes to workers' safety, this past year has been
a painful lesson on how important it is for every person to
have a safe workplace. But even before the pandemic, our Nation
saw 5,000 workplace deaths a year, one every 99 minutes. And
on-the-job deaths have disproportionately spiked for Black and
Latino workers since 2016, increasing 8 percent and 25 percent
respectively, compared to just 3 percent overall. And while we
know the economic cost of these deaths, a substantial $250
billion a year, the loss to families is immeasurable.
PROTECTING WORKERS AND THEIR WAGES
That is why the Occupational Safety and Health
Administration was founded 50 years ago, with the mission to
protect worker health and safety. President Biden's budget
would help us recommit to that mission by increasing OSHA's
(Occupational Safety and Health Administration) funding level
by 73 million from last year, and that will help the agency
hire more staff, provide more assistance to workers and
businesses, hold employers accountable to providing safe,
healthy workplaces, and ultimately save lives.
In addition to protecting workers' lives, this budget also
includes funding to protect their wages. It would provide
$276.5 million to the Wage and Hour Division, an increase of
$30 million. This agency investigates employer wage theft and
illegal compensation practices used to cheat people out of
their hard-earned wages, something which most commonly happens
to women, workers of color, and foreign-born workers. The Wage
and Hour Division recovers, on average, $1,120 per affected
employee. And they do it with a staff of barely 1,300 people
covering 148 million workers at over 10 million workplaces.
The funding in this budget would help them expand their
capacity, and put even more money back in the pockets of even
more workers who have been cheated by their employer. And
President Biden's budget not only invests in accountability for
employers in our country, but also in accountability for our
trading partners. So workers in Washington State, or Missouri,
or across the country, don't pay the price for unfair labor
practices across the world.
This budget increases funding for the International Labor
Affairs Bureau (ILAB) by over a quarter, including $19.16
million for ILAB to expand monitoring and enforcement of worker
rights under our trade agreements and preference programs, and
critical new investments to fight forced labor and child labor.
This budget also provides support to help workers
struggling in light of the economic crisis caused by COVID-19,
including the millions who have lost jobs, and especially
women, workers of color, and others who have been most set back
by it.
TRAINING AMERICA'S WORKFORCE
President Biden's budget would increase funding for
registered apprenticeships by $100 million, an increase well
over half of what its budget was last year.
These are proven apprenticeship models and lead to good-
paying jobs in high-demand fields. Funding for them will help
address long-standing inequities in apprenticeships, and change
the fact that women and workers of color are historically
underrepresented in these apprenticeship programs, and in the
careers that they lead to.
The budget would also increase funding throughout the
workforce training system, including with the $203 million
increase for workforce development State grants, which help
States make investments in career pathways for youth, and
support adults and dislocated workers, including those most
affected by the pandemic, and a new National Youth Employment
Program, and Veterans Clean Energy Training Initiative.
Secretary Walsh, I look forward to hearing more about your
plans here.
MODERNIZING UNEMPLOYMENT INSURANCE SYSTEMS
And finally, this budget includes funding to administer and
improve State unemployment insurance systems. This COVID-19
pandemic made really clear what a lifeline that support can be,
and how outdated and inadequate some of our systems are. This
budget would help modernize our unemployment insurance system,
and address vulnerabilities, inefficiencies, and other issues
with processing these critical benefits, so families can get
the support they need faster.
Of course, the need for better unemployment insurance
systems, workforce training programs, and workplace safety are
just a few of the many issues we have to tackle in the wake of
this pandemic.
EMPOWERING AMERICA'S WORKERS
If we want a stronger economy, if we want a stronger
country it all starts with stronger rights for workers. We also
need to make sure workers are safe from pandemics, sexual
assault, and harassment, and more. We need to make sure workers
have paid family, sick, and medical leave, quality, affordable
childcare, a livable minimum wage of $15 an hour, without
exceptions, and a secured retirement.
We need to make sure workers are not disadvantaged by pay
inequality. We need to address the inequities in our economy
that makes things so much harder for women, workers of color,
workers with disabilities, and others.
And we need to defend and strengthen the right to form and
join a union, a right, which allows workers to secure better
pay and benefits, and safer working conditions. This budget is
a bold step in the right direction. And my colleagues and I
have proposed other steps as well.
Secretary Walsh, I look forward to working with you and
President Biden in the months ahead to support workers in our
country.
With that, I will turn it over to Senator Blunt for his
opening statement.
STATEMENT OF SENATOR ROY BLUNT
Senator Blunt. Thank you, Senator Murray.
Good morning, Secretary Walsh. Welcome to the committee. I
look forward to your testimony today, and the chance to talk
about the Department's budget request for the coming year.
You know, the past 18 months have been challenging for our
country. The COVID-19 pandemic put unprecedented strain on the
economy, on its workforce, and on families who suddenly were
dealing with issues they hadn't expected to deal with, and that
families hadn't dealt with in the same way before.
Prior to the COVID-19 Public Health Emergency Declaration,
the unemployment rate was 3.5 percent. That was the lowest
since the late 1960s. I think you have to assume from that,
that some of the things that we are doing that were different,
were making a difference. But at the height of the pandemic, in
April of 2020, our unemployment rate exceeded 14 percent. While
we have made great strides in bringing our unemployment rate
back down since that point, I am concerned we won't reach the
3.5 percent pre-pandemic number due to, frankly, some misguided
Federal policies, specifically the additional $300 in Federal
supplemental unemployment payments that have unintentionally
incentivized unemployed individuals to remain exactly that,
unemployed.
In May of this year, the weekly--the average weekly
unemployment check in the country was $318. That is a bigger
check than a lot of people had taken home before, and you
didn't have the expenses of going to work. And so frankly, a
lot of people did not go to work. While businesses in America
have been searching for workers, this benefit has really
misaligned the workforce needs across the Nation.
And in Missouri recently, I continue, to see ``Help
Wanted'' signs all across the State, and in my hometown of
Springfield, these help wanted signs often included hiring
bonuses, and pay well above the $10.30 minimum wage in our
State. Missouri, like many States across the country, has
decided to end the Federal supplemental payment to increase the
level of participation in the economy.
I believe that it is beginning to work, but I also believe
it is now time for Congress to recognize the importance of
balancing, providing a safety net when you need it, and
ensuring that our labor needs are met. We need to create an
environment for Americans to thrive, where people want to go
back to work, where they are encouraged to go back to work, and
where people who can't go back to work have a basic
unemployment benefit.
However, I am concerned that some of the components of the
Department's budget request, and particularly some of the
increases, don't consider this, or the very real needs of local
communities, and the needs for a workforce to be more actively
engaged. Really, too much of this budget is driven by the
politics of the administration. Now every administration
should, and has every reason to make some changes. I think this
budget makes way too many changes, in way too short a time.
For example, instead of focusing funding on flexible
workforce training, determined by States to meet their own
unique employment needs, the administration is tying training
funds in many, many cases to green jobs. I am not opposed to
green jobs. I am just opposed to the Federal Government
deciding how States approach the needs they have right now.
According to the analysis of the U.S. Energy and Employment
Report, and the Department of Labor's Bureau of Labor
Statistics, when compared to jobs in fossil fuels, jobs in
solar, and wind power, employ a larger share of individuals in
their construction, rather than more permanent roles, as plant
managers, and other jobs. These jobs don't pay enough, and are
unionized at lower rates.
Mr. Secretary, I agree with you, and we have talked about
this, that we really need to target funding to the workforce of
the future. However, I think it is unlikely that the Federal
Government alone will be able to figure out what that workforce
of the future should look like. And we need to have more
involvement from States, communities, and local economies.
Now, we are going to disagree on some things in this
budget, but I am encouraged to see things we are going to agree
on. For instance, the increase of the apprenticeship program, I
think this has been, and needs to continue to be a successful
tool to allow workers to get paid while they train. And
frankly, to find out as early as possible, if what they think
they want to do is not meeting their expectations. So they
don't get way too far down a line before they realize, this is
not what I want to do.
This budget supports programs that are targeted to the
hardest hit parts of the country. For instance, the Appalachian
and the Lower Mississippi Delta regions have challenges there.
And I think your budget does what it needs to, to begin to
allow us to look at those challenges; there is support here for
veterans transitioning to civilian workforce, one of the key
priorities of this committee, and I think of this Congress.
Mr. Secretary, we are in a challenging environment. It is
going to be a difficult year. I believe we can work toward
consensus with the Department's budget, but frankly, as I have
said at our other budget hearings this year, I think this can
only be achieved by more parity between the defense and
nondefense funding. The President's budget request did not
achieve that goal. However, I remain confident that the final
appropriations bill will.
And Mr. Secretary, I am glad that you plan to be in St.
Louis tomorrow. I know we were told yesterday a couple of the
things you would be talking about: one, promoting vaccines, and
the other, the Job Corps. On the vaccine front, I was talking
about this at our leadership stakeout yesterday. I have talked
about it I think in every event I have been in in Missouri
since we started the Warp Speed effort to try to get vaccines
available more quickly.
Vaccines are a necessary, an absolutely necessary part of
us creating an environment where this virus can't continue to
replicate itself and change in new ways, and the variants are
going to be the future enemy. Vaccine is the answer to those
variants.
On Job Corps, Senator Murray, and I, and the committee have
worked together the last 6 years to increase that funding. I
know those programs continue to be programs that we can do more
with and, can look for reforms in. And I look forward to your
leadership in that area.
So again, thank you for your time here today. I look
forward to working together, as we try to be sure that
Americans, working families, have the opportunities they need,
and that our economy continues to grow. Thank you, Senator.
[The statement follows:]
Prepared Statement of Senator Roy Blunt
Thank you, Chair Murray. Good morning and welcome, Secretary Walsh.
I look forward to your testimony on the Department of Labor's fiscal
year 2022 budget request.
The past 18 months have been challenging for our nation. The COVID-
19 pandemic put unprecedented strain on our economy and its workforce.
Prior to the COVID-19 public health emergency declaration, the
unemployment rate was at 3.5%, the lowest since the late 1960s. At the
height of the pandemic, in April 2020, our unemployment rate exceeded
more than 14%. While we have made great strides in bringing our
unemployment rate back down since that point, I'm concerned that we
won't reach that 3.5% pre-pandemic number due to misguided federal
policies.
Specifically, the additional $300 in federal supplemental
unemployment payments have unintentionally incentivized unemployed
individuals to remain exactly that: unemployed. While so many
businesses in America are searching for workers, this excessive benefit
seems misaligned with the workforce needs across the nation.
When I was in Missouri recently, I saw ``help wanted'' signs across
the state. In my home town of Springfield, these ``help wanted'' signs
included hiring bonuses and pay well above the $10.30 minimum wage in
the state. Missouri, like many states across the country, has decided
to end the federal supplemental payment to increase the level of
participation in our state's economy. And I believe it is now time for
Congress to recognize the importance of balancing providing a safety
net, when needed, with ensuring that our labor needs are met.
We need to create an environment for Americans to thrive--where
people want to go back to work, where they are encouraged to go back to
work, and where people who can't go back to work have a basic
unemployment benefit. However, I am concerned that some components of
the Department of Labor's budget request, and particularly some of the
increases don't consider this or the very real needs of the local
communities. Instead, too much of the budget is engrossed in the
politics of this Administration.
For example, instead of focusing funding on flexible workforce
training determined by states to meet their own unique employment
needs, the Administration is tying training funds to ``green jobs.''
Yet, according to an analysis from the U.S. Energy and Employment
Report and the Department of Labor's Bureau of Labor Statistics, when
compared to jobs in fossil fuels, jobs in solar and wind power employ a
larger share of individuals in their construction rather than in more
permanent roles as plant operators; these jobs also don't pay as much,
and are unionized at lower rates.
Mr. Secretary, I agree with you that we should target funding to
the workforce of the future. However, I think it's wrong for the
federal government to dictate what that workforce should look like, and
for bureaucrats in Washington, DC to determine the speed at which we
get there. That should be left up to states, to communities, and to
local economies.
While we may disagree on this point, there are many components of
the budget request on which we do agree. I'm encouraged to see an
increase for the Apprenticeship Program--which has been a successful
tool to allow workers to get paid as they train--support for programs
targeted to the hardest hit parts of our country--in the Appalachian
and Lower Mississippi Delta regions--and support for our veterans
transitioning to the civilian workforce.
Mr. Secretary, we are in a challenging environment and this is
going to be a difficult year. I believe we can work toward consensus
with the Department's budget, but as I have said at other FY2022 budget
hearings this year, this can only be achieved when there is parity
between defense and non-defense funding. The President's budget request
did not achieve this goal. However, I remain confident that final
appropriations bills will.
Thank you for your time here today. I look forward to working with
you to strengthen our nation's workforce and create a more prosperous
economy for all Americans. Thank you.
Senator Murray. Thank you, Senator. Thank you.
And with that, we will turn to Secretary Walsh. Welcome to
our committee. And you may begin your testimony.
SUMMARY STATEMENT OF HON. MARTIN J. WALSH
Secretary Walsh. Thank you very much, Chairwoman Murray, I
appreciate it; and Ranking Member Blunt, and the members of the
subcommittee, thank you for having me today.
I look forward to aligning the Biden-Harris
administration's version of the Department of Labor's fiscal
year 2022 budget and beyond. And I am excited to be here in
person. This is my second in-person hearing. My first was my
confirmation. So if I make some mistakes, bear with me until I
get used to this process. So I truly appreciate it.
I want to just start by saying how humbled and honored I am
to be here, as the son of Irish immigrants, and a member--my
father was a member of the Labors Union in Boston, to lead the
Department of Labor. Just to think about their journey to
America, and having their son sitting in front of Congress--in
front of the Senate today.
I also believe, as the President says, we are at an
inflection point in our Nation's history right now. We are
coming out, as was mentioned a couple of times, of a pandemic
that has taken over 600,000 American lives. And it has pushed
working people to the breaking point in so many different ways,
in so many different corners of our country.
The President and Congress worked together to pass the
American Rescue Plan. It changed the course of the pandemic. It
delivered relief to the American people, and it certainly set
us on a pathway to recovery. At the Department of Labor, the
team over there is working hard to implement this plan, from
strengthening our unemployment systems to fully subsidizing the
corporate premiums, to protecting workers' health and safety.
But there is certainly much more work to be done. We need
to build back better. That means putting workers at the center
of a more resilient, more inclusive, and ultimately more
competitive economy as a country. That is what the President's
economic vision is all about.
The Bipartisan Infrastructure Framework negotiated with
members of the Senate would rebuild our communities and create
millions of good jobs all across this country. And the Build
Back Better agenda would make historic investments in working
people through job training, and education, which I think we
can all agree on, the CARES economy, and paid family leave, and
medical leave, and workers' rights and protections.
BUDGET INVESTMENTS
Building on that vision, the Department of Labor's fiscal
year 2022 budget request proposes an investment of $14.2
billion. That is, as the Chairwoman mentioned, a 14 percent
increase over 2021 enacted levels. That includes $3.7 billion
in Workforce Innovation and Opportunity Acts, and the Wagner
Peyser state formula grants. It is an increase of 6 percent.
That is about creating more pathways to good-paying jobs for
workers who need them the most. And we have seen it with people
unemployed now, and underemployed, the opportunity to make
those investments.
This budget also would invest $285 million in registered
apprenticeship programs. That is an increase of $100 million
that would allow us to expand and diversify a model of economic
mobility that has proven to produce results for both workers
and employers all across this country.
For unemployment insurance, we would fully fund and update
the formula for what States receive to administer UI
(Unemployment Insurance), it is the first update, quite
honestly, in decades. We also request $100 million for
technology solutions to prevent fraud and ensure access to UI
benefits for all people that need them.
For our worker protection agencies, this budget requests
$2.1 billion, a 17 percent increase. We need to rebuild and
strengthen our capacity to protect workers, wages, benefits,
and rights, and safety on the job sites.
This budget also requests $100 million for the multiagency
POWER Plus Initiative that is aimed at empowering displaced
workers in coal communities with new--with new skills and new
job opportunities. And it requests $20 million for a new
program to help veterans. The ranking member mentioned this. It
is transitioning services for members and military spouses to
get good careers in clean energy.
It was developed with the Department of Labor--with the
Department of Labor's Department of Veterans Affairs. Across
the Department of Labor's work, this budget invests in those
who have been shut out of economic opportunities in the past,
from women, and people of color, to rural Americans, and
veterans, to at-risk youth, justice-involved adults, and people
with disabilities.
The pandemic proved that the systems failing some workers
end up failing all workers, and failing our country,
ultimately. But we have an opportunity to do better now, coming
out of the pandemic. We can empower all American working
people. It is a moment in history when we need to move forward
together, we need to come together.
Madam Chairwoman, Ranking Member, thank you for the
opportunity; I know that we will have many more conversations,
and we will work together to support the economic recovery that
works for all American workers.
I look forward to discussing the budget proposals and
requests with you and the committee today. And I am happy to
respond to any questions that you have. And if I do not have an
answer to your question, I guarantee you our team will get back
to you in the next couple of days with questions--answers that
I don't have today. So thank you.
[The statement follows:]
Prepared Statement of Martin J. Walsh
Chairwoman Murray, Ranking Member Blunt, and members of the
Subcommittee, thank you for the invitation to testify today. I am
pleased to appear before this Subcommittee for the first time and to
outline the Biden Administration's vision for the Department of Labor
in Fiscal Year (FY) 2022 and beyond. I am honored and humbled to lead
the Department in its critical work.
The Department's mission is to foster, promote, and develop the
welfare of the wage earners, job seekers, and retirees of the United
States; improve working conditions; advance opportunities for
profitable employment; and assure work-related benefits and rights.
This mission is personal to me and my family's story. My father's
participation in the Laborers Union, Local 223 in Boston, was the
pathway to a fair wage, so my family was not worried about housing
insecurity. My parents had a safe workplace, so I never knew the fear
of them not returning from work. The job came with a pension, so my
parents could retire with dignity. And the job included health
insurance, so that when my parents experienced the worst nightmare of
having a child diagnosed with cancer, they had health insurance so that
I could be treated and recover.
Years later, I followed my father into construction and joined the
same union, and experienced those same benefits of having a safe
workplace, health insurance, a fair wage, and a pension. These are not
abstract policies--these are life-changing rights. I have spent my
career fighting for the rights of working people as a State
Representative, as General Agent for the Metro Boston Building Trades
Council, and as Mayor of Boston. I feel privileged to continue this
work as the Secretary of Labor.
american rescue plan
As a former Mayor, I know that our communities--and our families--
have been hit hard by the COVID-19 pandemic. That's why it was so
important that Congress worked with President Biden to pass the
American Rescue Plan (ARP) to change the course of the pandemic and
deliver immediate relief for American workers. In terms of jobs, not
only did the ARP extend unemployment insurance benefits for our friends
and neighbors who lost their jobs during this pandemic, but it also
laid the groundwork for shoring up and modernizing our unemployment
insurance system to help workers get the benefits they deserve when
they need them. The ARP also helps workers who lost their jobs or had
their hours reduced pay for health insurance by fully subsidizing COBRA
premiums for eligible individuals from April 1 through September 30 of
this year. And it provides additional funding for the Department to
help keep vulnerable workers healthy and safe. Finally, ARP also
distributes more than $360 billion in emergency funding for state,
local, territorial, and Tribal governments to ensure that they are in a
position to keep front line public workers on the job and paid, while
also effectively distributing the vaccine, scaling testing, reopening
schools, and maintaining other vital services. We appreciate this
landmark law, and we are working hard to ensure that this law is
implemented in the way that Congress and the President intended to
reopen our economy.
american jobs plan
As a former construction worker, I know a good job can change your
life. One of the most important things we do at the Labor Department to
improve the economy and strengthen the workforce is help people pursue
training that leads to good jobs and helps close racial and gender
equity gaps throughout the economy. The President's American Jobs Plan
is a historic investment in the working people of America. It will
create millions of good paying, family sustaining jobs that rebuild the
middle class by empowering our workers to build America's future.
The President's plan provides funding for sector-based training
programs focused on growing, high-demand sectors, such as clean energy,
manufacturing, and caregiving, helping workers of all kinds to find
good-quality jobs in an ever-changing economy. In addition, the plan
provides for a new Dislocated Workers Program that provides
comprehensive supports for workers who have lost jobs through no fault
of their own, to ensure they are able to successfully participate in
training that can prepare them for in-demand jobs. The plan will
prioritize workforce development opportunities for underserved
communities and ensure job opportunities are open to, and support,
women, people of color, people with disabilities, and people impacted
by the criminal justice system, among other disadvantaged groups.
Further, subsidized jobs programs will support unemployed and
underemployed workers who have faced significant barriers to employment
to gain a key foothold in the labor market. Additional investments to
establish more pathways to good jobs include creating up to two million
new registered apprenticeship slots, while strengthening access for
women, people of color, and individuals with disabilities; creating
career pathway programs in middle and high schools, including those
that increase access for underrepresented students to computer science
and other STEM sectors; and supporting community college partnerships
that build capacity to deliver job training programs that lead to good
jobs. The plan also makes key investments in expanded career services
and adult literacy programs to equip job seekers with the tools,
information, and foundational skills they need to be successful in the
labor market.
The plan provides critical funding to strengthen the capacity of
our labor enforcement agencies to prevent discrimination, protect wages
and benefits, enforce health and safety rules, and strengthen health
care and pension plans. In addition to these investments, the President
is calling for increased penalties when employers violate workplace
safety and health rules, which have proven inadequate to address
serious violations.
fy 2022 budget: supporting america's workers through the pandemic to
recovery
Building on the American Rescue Plan and the American Jobs Plan,
the Department's FY 2022 budget proposes investments in workers and in
our country's future: a future of opportunity and shared prosperity, a
future of robust job growth and a thriving middle class, a future where
workers nationwide get the skills and training that leads to jobs that
pay a fair wage without risking their health or safety. The
Department's budget requests an investment of $14.2 billion in
discretionary resources, which is a 14 percent increase above the FY
2021 enacted level.
The budget includes resources to expand training opportunities,
supporting workers and building a better future. There is no single
path to a good-paying job, and the country's future growth and
prosperity depend, in part, on ensuring workers have multiple pathways
to high-quality, good-paying jobs. To that end, the budget requests
$3.7 billion, a six-percent increase, for the Workforce Innovation and
Opportunity Act and Wagner Peyser state formula grants to make
employment services and training available to more dislocated workers,
low-income adults, and disadvantaged youth hurt by the economic fallout
from the COVID-19 pandemic.
The budget also invests additional resources in programs that serve
marginalized groups, such as justice-involved individuals, at-risk
youth, and vulnerable veterans. While higher-income earners have
recovered many of the jobs lost, workers in low-wage industries have
experienced persistent net loss. As seen in the June 2021 Employment
Situation, disparities among workers continue, and over 5.7 million
jobs that existed last February are yet to return. While the overall
unemployment rate was 5.9 percent, the African American unemployment
rate was 9.2 percent and the Hispanic rate was 7.4 percent, compared
with 5.2 percent for Whites. For individuals with disabilities, the
unemployment rate was 10.9 percent. Due in large part to the impact of
the pandemic, there are roughly 3.4 million fewer women working now
than there were in February 2020--and many women have had to reduce
their hours, often in response to caregiving demands. Women,
particularly women of color, continue to face barriers to good jobs
with equal pay. The budget prioritizes investments in these communities
of color, with a goal of increasing success for all groups, because
systems that are failing these populations are failing us all.
The Department will continue to invest in proven approaches, such
as expanding the Registered Apprenticeship model by investing $285
million, an increase of $100 million, which will allow the Department
to create a more balanced apprenticeship portfolio, support states'
efforts to implement a reauthorized National Apprenticeship Act, and
further the development of youth apprenticeship and pre-apprenticeship
opportunities, all while increasing equity for under-represented
populations. Registered Apprenticeships provide a pathway to good-
paying jobs, and as Secretary of Labor, I am committed to expanding
these opportunities across the United States, in order to help rebuild
the middle class and create millions of new opportunities for workers
to enter into relevant, high quality training that both protects
workers' rights and propels workers into career paths that provide a
sufficient and fair wage. Registered Apprenticeships produce strong
results for both employers and workers. The Department's investments in
Registered Apprenticeship will work to address the systemic disparities
that have impacted women, people of color, and other under-served and
under-represented populations.
This last year has again demonstrated that Unemployment Insurance
(UI) is an essential social insurance program and economic stabilizer,
and it has been a lifeline to millions of workers and to the economy
throughout the pandemic. Yet the pandemic uncovered longstanding
problems in the UI system, including the challenges facing states'
administration of their UI systems. These systems, in part as a result
of persistent underfunding and inadequate technology, have been plagued
by delays and obstacles that disproportionately affect workers of
color. When benefits are slow to reach workers who have lost their
jobs, it delays both their recovery and negatively impacts the country.
To address these challenges, the budget provides resources to ensure
States can better handle higher volumes of claims and be better
prepared for future crises or high unemployment levels. The budget
request fully funds and updates the formula for determining the amount
states receive to administer UI--the first comprehensive update in
decades. In addition, the budget requests $100 million to support the
development of information technology solutions that can be deployed in
states to ensure timely and equitable access to benefits. The $100
million increase will further support and complement the resources the
Department was appropriated under the American Rescue Plan to prevent
fraud, promote equitable access, and ensure timely payment of benefits.
The Biden-Harris Administration has taken stock of the challenges
the unemployment system faces and developed a set of high-level
principles that should guide future efforts to reform the UI system.
Those principles include ensuring adequate benefit levels and duration
for unemployed workers; ensuring the UI system can ramp up quickly and
automatically in response to recessions; addressing the lack of access
to UI for workers misclassified as independent contractors, low-income
and part-time workers, and workers with non-traditional work histories;
shoring up UI trust funds; and improving UI program access and
integrity.
The budget request includes $2.1 billion--a 17 percent increase in
funding--for our worker protection agencies, enabling the Department to
conduct the enforcement and regulatory work needed to ensure workers'
wages, benefits, and rights are protected, address the
misclassification of workers as independent contractors, and improve
workplace safety and health. These are the staff who recover back wages
owed, help prevent fatalities and life-altering injuries or illnesses,
respond to whistleblower complaints, reduce exposure to cancer-causing
agents, help ensure retirees get their benefits, and address pay
inequities.
Over the past four years, the Department's worker protection
agencies have lost 14 percent of their staff. A lack of enforcement
makes workers more vulnerable to workplace violations. The President's
budget reverses this trend by proposing $304 million in additional
funding for the Department's worker protection agencies, including $73
million for the Occupational Safety and Health Administration, $67
million for the Mine Safety and Health Administration, $35 million for
the Office of Federal Contract Compliance Programs, $31 million for the
Wage and Hour Division, and $37 million for the Employee Benefits
Security Administration.
The budget continues the President's commitment to tackling the
climate crisis. For the Department, the request includes an additional
$100 million investment in an initiative as part of the new Interagency
Working Group on Coal and Power Plant Communities and Economic
Revitalization, aimed at reskilling and reemploying displaced workers
in legacy energy communities. The request also includes $20 million for
a new discretionary program, developed in collaboration with the
Department of Veterans Affairs, which is focused on helping
transitioning service members, veterans, and military spouses to pursue
careers in clean energy, which will help combat climate change, while
preparing this population for good-paying jobs.
I know we will have a lot of conversations, as we collaborate on
the American Jobs Plan and the FY 2022 Budget. I look forward to those
collaborations and partnering with you all to invest in the nation's
economic recovery. The Department plays an important role in expanding
opportunity.
Madam Chairwoman, Ranking Member, thank you for the opportunity to
testify. I look forward to discussing our budget request with the
committee, and I am happy to respond to any questions you may have.
Senator Murray. Thank you very much, Mr. Secretary. We will
now begin a round of 5-minute questions of our witness. I ask
our colleagues to please keep track of your clock and stay
within your allotted time.
OSHA INCREASES IN THE AMERICAN RESCUE PLAN
I appreciate that the budget addresses the need to rebuild
and strengthen the capacity of the occupational safety and
health administration. Under the previous administration, OSHA
didn't do more than issue non-binding guidance on how employers
could protect workers from COVID-19. And that left a lot of
workers exposed, as we witnessed thousands of deaths and
illnesses of workers in healthcare, and meat packing, and other
essential industries.
Now, the Biden administration recently issued an Emergency
Temporary Standard, but it does not yet cover all frontline
workers. And as you know, OSHA received $100 million in the
American Rescue Plan, which it plans to use to support more
than 80 compliance and safety health officers, among some other
priorities. But as the economy continues to reopen, and more
contagious COVID variants emerge, workers need OSHA to be fully
engaged in its job of making sure employers provide a safe
workplace for their employees, and their workers.
So I wanted you to describe for the committee this morning,
your plans to use those ARP (American Rescue Plan) funds to
hire the staff OSHA needs to do its job, and how quickly do you
expect to get these staff on the job.
Secretary Walsh. Thank you very much, Madam Chair. OSHA is
one of the areas that, when I was sworn in, work had already
begun there, due to the help of the American Rescue Plan, and
investments in staffing up. They were severely understaffed to
be able to make sure that we keep our workplaces safe in
America. Certainly, we have a difficult time keeping up with
the average volume of business, but if you throw COVID-19 and
the atrocities of some of the workplaces in our country with
COVID-19, it made it very complicated.
We are currently in the process of hiring up and staffing
up in OSHA so that we can have more inspectors to go out to job
sites. Quite honestly, I would love OSHA, at some point--we are
asking for an increase in this budget--I would love OSHA at
some point to get to a point where we are not responding to
accidents on the job site, that we are actually being proactive
working with businesses, in how do we create better, safer work
conditions, and work sites.
We are not at that point right now, so we are at the point
where we are still looking to staff up, and hire up. And also
just--and I have spent many, many hours on Zooms with the OSHA
employees across the country, just thanking them for their
work, because throughout the pandemic OSHA employees went to
work every day. They didn't have the luxury of sitting home on
a Zoom and doing their job. They had to be on a job site. They
had to be touring facilities, and they had to see some of the
toughest situations out there. So I look forward to working
with this committee and continuing the staffing up of OSHA.
OSHA INCREASES IN FISCAL YEAR 2022 BUDGET
Senator Murray. Well, the budget requests an increase of
$73 million for OSHA in fiscal year 2022. Can you describe why
those funds are needed in addition to the ARP funds that were
provided?
Secretary Walsh. Yes, because--thank you. With the ARP
funds as it just--it restores us back to where we were pre-5-
years-ago. What the new funds allow us the opportunity to do is
expand the office and to get into some of the other work that
we want to do. People should not be, businesses should not look
at OSHA as a burden. People should be looking at OSHA as a
partner, and being able to create opportunities to help create
safe work environments.
When I was a young person working on construction sites,
and OSHA came on the job, they would come on the job to
investigate, but they were not investigating after an accident
happened, they were not investigating after a tragedy happened,
they were making sure that there were proper procedures in
place there to make sure that workplaces are safe.
We need to do work around this country to make sure that
our workplaces are safe, that workers are safe. And that we
collectively work with businesses as well as we move forward
here. So that additional revenue will go into continuing to
hire up in OSHA, and to create better opportunities to
training, and to have the best prepared--OSHA inspectors we
have in the country.
Senator Murray. You didn't mention whistleblower
complaints, but I understand that last year the inspector
general reported a significant increase in complaints, and
insufficient staff to investigate those complaints. What are
you going to do to address that issue?
Secretary Walsh. Again, it is about the staffing when--I
might have the numbers wrong--let me just get the numbers here
for you. We are going to double the number of inspectors by the
end of the administration, the first administration, Biden-
Harris administration, the first term, we are about--we were at
about 360 inspectors in the country, inspecting about 170
million workers in our country. That certainly is not going to
do the job.
So what we are doing here is making sure that we have
enough inspectors out there that when an employee calls the
office with a complaint, we are able to respond to that, and
not have it sit in a pile, or sitting in an inbox somewhere.
And again, it is about when you think about whether it is OSHA,
Wage and Hour, the Department of Labor was down about 3,000
employees to where it was 4 years ago.
And when you are down employees in the Department of Labor,
the Department of Labor is an agency, as you know, that is out
there protecting workers. If we don't have the staff and don't
have the employees to protect the workers, then we can't be on
the job sites, we can't be checking Wage and Hour, we can't be
making sure that people are working in safe conditions.
So our intention, with this investment that we are asking
for today, and with the intention of the American Rescue Plan,
to staff back up, to build back pre-4-years-ago level, but also
enhance that.
Senator Murray. Okay. I have a number of other questions,
and I am going to ask them at the end, so our other committee
members can have their time.
I will turn to Senator Blunt.
CREATING A WELL-PREPARED WORKFORCE
Senator Blunt. Thank you, Chair. Let me start with a
question that is really going to be more of a question I will
follow up with later, but I want to be sure we cover this. You
and I have talked about this before, Mr. Secretary, the idea
that people don't get the information they need early enough to
decide what kind of job is out there, what their personal sense
of job satisfaction would be, and what those jobs pay.
A few years ago I went with the Secretary of Labor to the
Carpenter Training facility in St. Louis, and as we visited
individually, the people, at the end of that visit, they were
all in their late-20s; they all had a similar story, and it was
sort of that lost decade of not knowing what they wanted to do,
or not having information about the importance of benefits, the
importance of job satisfaction.
And we have looked at that as sort of a lost decade that we
would like to avoid. It is hard to recover, frankly, from that
lost decade. You ask for $10 million to continue to pursue that
in your budget. The Secretary of Education didn't ask for the
$10 million education had last year. We put $10 million in both
budgets.
At some point when you have had time to think about this
more, I am going to ask you, I will be asking the Secretary of
Education what the two of you are doing to try to close that
gap between getting the information you need. If you want to
talk about the importance of knowing what jobs are out there
sooner rather than later. Just let me let you do that for a
moment.
Secretary Walsh. No. Thank you, ranking member. And to be
quite honest with you, I want to ask--add another component to
that: the Secretary of Commerce. So the Secretary of Commerce,
Gina Raimondo; the Secretary of Education, Secretary Cardona,
and myself, have had conversations. And when you think about
the jobs of the future, the three of us, the three of our
departments catch people--catch employers in educational
opportunities to prepare people for the future.
So what we are doing is, we are working collectively
together to make the investments. Gina Raimondo is working with
the business community as well as I am, to find out where the
gaps are, where they need employers--employees now, and in the
future, working with education on how do we create those
programs in our primary schools, in our high schools? How do we
create those opportunities in community college moving forward?
And the Department of Labor is offering--obviously has the
workforce development grants, and the workforce grants to be
able to fund those jobs. So it really has to be real
intentional work that we are doing here to make sure that this
money that we are asking for today, and the money through the
rescue plan, and potentially, through the CARES Economy Plan,
that this investment is preparing workers of the future.
ADAPTING TRAINING PROGRAMS TO MEET INDUSTRY NEEDS
You just said it yourself. I mean, when you think back and
look at the history of this country, and you look at the
investments that were made in the '50, and '60s and '70s, lots
of schools around America had training--had Vo-Tech schools,
and they were doing Vo-Tech training, and young people that
were going to those programs were going into the trades. That
would become an electrician, plumber, carpenter, laborer, and
mechanic, what have you.
Many of those programs are very different today. And I
think we are at a moment in time, coming out of a pandemic, or
getting through a pandemic, I should say--we are not out of it
yet--that we have an opportunity right now to retrain and
reskill workers, young people, as well as some older workers as
well, into those careers. But it has to be a coordinated
effort, it has to be the secretaries of commerce, labor, and
education, and it has to be Democrats and Republicans, quite
honestly.
Senator Blunt. All right. I am going to run out of time
here. I agree with that, but the component I want to be sure we
continue to add is like those Vo-Tech programs.
I was at a great new facility in Buffalo, Missouri, the
other day that they are building, and being focused again,
people need to know, sooner rather than later, what jobs are
out there, what those jobs pay. A lot of jobs that have that
kind of training actually produced greater satisfaction and
more income than jobs that you have a college degree for. And
sharing all that information early is important.
One way to create an early sense of what you want to do are
apprenticeships. Missouri, where you will be tomorrow, is
ranked second in the United States in apprenticeships. We are
working toward a goal in our State of having 20,000 active
apprenticeships by 2025. The one thing left out of that, it
appears to be the nontraditional industries and what we can do
to develop apprenticeships outside of the well-run trade union
programs, and other programs. For instance, like healthcare,
cybersecurity, even finance. What can we be doing to think
about how we expand that apprenticeship opportunity to new
fields?
Secretary Walsh. Well, what I have been doing, and what we
are going to continue to do is talk to companies, the tech
companies as well. We have opportunities in tech, and biotech,
and high-tech, and even pharmaceuticals. So having
conversations with those industries on how we create pathways
into those industries would be important. Those are good-paying
jobs, and they are looking for people.
And quite honestly, we have a huge opportunity right now in
this country to really think about those apprenticeships, and
how do we create more apprenticeships; and the beauty is--I
know my time is over--the beauty is, is the apprenticeships you
are paying while you are learning. And that is the difference
between workforce development and job training. You are
actually getting paid in the apprenticeship while you are
learning on the job.
Senator Blunt. Right.
Secretary Walsh. And that allows a person that might be
unemployed or underemployed right now, to get on-job
experience, real-life experience moving forward.
Senator Blunt. Thank you, Secretary. I will have some more
questions also later, Chairwoman. And thank you for the time.
Senator Murray. Thank you.
Senator Reed.
SHORT-TERM COMPENSATION PROGRAM
Senator Reed. Thank you very much, Madam Chairwoman.
And congratulations, Secretary Walsh, I am glad you are
there in the Department. Let me raise the first question about
the Short-Term Compensation Program, or otherwise known as
``work sharing''. After the last recession in 2010/2009, it is
estimated that we saved 570,000 jobs. And I know Congress and
the Biden administration stepped up and they are providing
fiscal support for this program, and it is saving tens of
thousands of jobs.
And as you know, what it does is it basically provides 1 or
2 days on unemployment compensation while the individual works
at the facility. Can you explain how, and if you will continue
to support this program, and try to extend it to every State in
the union?
Secretary Walsh. Thank you very much, Senator. And thank
you for raising this issue. Work sharing certainly is an
important and innovative tool. I agree with you, and I wished
that we had seen it across the States, and we want to see it
across the States. I think it is going to be very important for
the future of our workforce. It is important that we continue
to explore that. I am going to, as Secretary of Labor; our
Department is. The Department is certainly committed to
promoting State adaptation of this program.
And we are going to continue to find ways to increase
awareness and participation in the program. We have seen--you
have seen the benefit of it, and I think that--and workers are
seeing the benefit of it. And I think that those are
opportunities for us throughout the United States of America
for other States, and other workers, more honestly, to see the
benefit as well.
So I know that, Rhode Island, they have been a leader on
this, and I want you to know that I want to continue to work
with you, and maybe some of the other members of the Senate, in
governance, quite honestly, around the country to expand the
program.
DEMAND-DRIVEN TRAINING PROGRAMS
Senator Reed. Thank you, Mr. Secretary. Switching gears a
bit, I secured about $28 million in the Defense Appropriations
Bills for a submarine, industrial-based support of workers, and
of training, and education initiatives. And I think you have
seen one of these when you visited Westerly, Rhode Island, and
saw our training program, where our Department of Labor,
together with Electric Boat collaborates. And I think this is
another example of what Senator Blunt was getting at. This
demand-driven model for training, it is not the old-fashioned:
We turn out X, we have always done that. It is: What does
business need?
And up in our place where Electric Boat, over the next
several years, is going to have to hire 17,000 people, many of
them machinist, welders, et cetera. So how are you going to
continue to work with the Department of Defense to support
programs like this, and with other agencies to support demand-
driven programs?
Secretary Walsh. Well, first of all, thank you for your
work on this. Ranking Member Blunt talked about this as well. I
think first I want to say is that, the jobs that you work with
your hands are now computer jobs, meaning that you have to have
not just the skill to be able to be the craft person working
with your hands, but you need to be able to learn and read off
a computer because the work has gone so technical.
The Department of Labor has just awarded the State of Rhode
Island a $3 million--$3.9 million grant to expand registered
apprenticeship opportunities. I think that this is one of the
areas that we have such a great opportunity. Electric Boat is a
great example. I was in Connecticut; we went through Rhode
Island to get to Connecticut. I know there is facility in Rhode
Island, as well, and the expansion that was going on there, and
the opportunity for employees.
I guess the best way I can sum it up is what I am going to
do about it is make sure that these investments are there, and
that we work with companies like Electric Boat, but the human
side of it. When I was at Electric Boat, I was talking to a
couple of apprentices that were standing there next to me, and
I got to talking with them.
And I am like: What are you doing? You know, did you go to
college? One kid went to college a little while, dropped out.
It wasn't for him. I told them my story. I dropped out of
college after a-year-and-a-half.
He is now on a pathway to a career. He is on a pathway to
working on submarines for the United States of America. He is
on a pathway to doing some amazing work. He is proud of his
work. He is happy with what he does. He told me he is earning
good money. He is making a living. He is able to raise a
family.
That is the type of stories that we need to continue to
happen. So I think it is incumbent upon us. If I do anything as
Secretary of Labor, it is making sure that the money in the
workforce development grants, in the apprenticeship program,
money that we get, we get out in the street because that, that
is going to be the fundamental, biggest game changer in the
United States of America, to get workers retrained, or workers
trained, and the ability to raise and get into the middle-
class. That is what we can do. That is the one thing. If I
accomplish anything and I do that, I will be happy.
COMBATING LITERACY ISSUES
Senator Reed. Well, thank you very much, Mr. Secretary.
Just a final point, not a question; as I was sitting down with
adult educators in Rhode Island a few weeks ago, they pointed
out that one of the problems is literacy; that they have a
significant number of adults who walk in and they want jobs,
they want to work, but they have very poor literacy, and very
poor numeracy and, digital skills too.
And I will just, not a question, but I assume, and I know
you will follow up with the Department of Education to try to
collaborate, to see how we can integrate our literacy programs,
as well as our training programs. And I will then--I won't
follow up with additional question. I will just, thank you.
Thank you, ma'am.
Senator Murray. Thank you.
Senator Kennedy.
Senator Kennedy. Thank you, Madam Chair.
BUDGET INCREASES
Mr. Secretary, welcome. I agree with you, by the way, for
what it is worth, about getting the money out on the streets,
literally. So I am looking at your budget here. Your current
budget is $12.5 billion. You are asking for $14.2 billion. Does
that sound about right?
Secretary Walsh. Yes.
Senator Kennedy. That is a 14 percent increase. You want an
extra $1.7 billion?
Secretary Walsh. Yes.
Senator Kennedy. Okay. Explain to me why the American
people would be better off giving you $1.7 billion, than taking
that $1.7 billion and spending it on infrastructure? I did a
little math and for $1.7 billion, we can resurface a four-lane
highway from Washington to Denver. So why are the American
people better off giving you more money than putting it on
infrastructure?
Secretary Walsh. Well, thank you very much, Senator. And
thank you for the question. It is a great question. And I think
the way I would think about it is the $1.7 billion increase to
my--to the budget, my budget is an investment in infrastructure
as well. It is an----
Senator Kennedy. It is what? I am sorry?
Secretary Walsh. Infrastructure investment as well. It is
an infrastructure investment in the American worker in this
country. It is an opportunity for us to look at, as I think
about the Department of Labor----
Senator Kennedy. Would you believe every--excuse me for
interrupting--I am sorry, Mr. Secretary.
Secretary Walsh. No problem.
Senator Kennedy. We don't have much time. Do you believe
that every expenditure by the Federal Government is an
investment?
Secretary Walsh. This----
Senator Kennedy. What is the difference between an
investment and an expenditure?
Secretary Walsh. An investment is an investment in the
future of workers, and expenditure is an expenditure in
building a bridge.
Senator Kennedy. Okay. Well, you have a union background,
which I respect and admire. If we took $1.7 billion that you
say you need, you need more to run your Department, and we
spent that on infrastructure. That is going to create a lot of
union jobs. Isn't it?
Secretary Walsh. It is going to create a lot of jobs, but
we are also not going to be able to educate the workforce that
needs those new jobs that are going to be created off of that
infrastructure investment of new bridges.
Senator Kennedy. But they are already educated. The people
building the roads are already educated. They are good at what
they do.
Secretary Walsh. Well, Senator Reed just mentioned of--an
issue around literacy in this country. So again, it is an
investment in helping people to be able to be retrained and
trained in the jobs of the future. I come out of construction.
I worked construction as well. The construction industry that I
worked on in the early-'90s and late-'90s is different than the
construction industry of today.
TAX INCREASES FOR INFRASTRUCTURE BILL
Senator Kennedy. Yes, sir. Let me stop you for a second. I
don't want to get too far afield here into a history of the
construction industry. I used to work construction too.
Let me be sure I understand what you are saying. When my
constituents call me and they say, look, you are being asked to
raise taxes to pay for infrastructure. Why, instead of putting
$1.7 billion in extra taxes on us, why did you give $1.7
billion to the Department of Labor? Why didn't you use that for
infrastructure? Am I just supposed to say, because the
Department of Labor says they are going to make an investment?
What metrics are you going to use this time next year to be
able to prove to this Congress that your investment paid off
better than $1.7 billion in infrastructure?
Secretary Walsh. Before I answer that, let me just quickly
go back to the tax question. I think the beauty for your
constituents is that the infrastructure bill that is being
negotiated right now does not raise taxes on the average
American who earns under $400,000. So the average American is
not paying for that.
Senator Kennedy. That is not true.
Secretary Walsh. Okay. Well, that is not why I am here
today.
Senator Kennedy. We just have to agree to disagree.
Secretary Walsh. It really----
DEPARTMENT OF LABOR SURVEYS
Senator Kennedy. Let me move on, because I have got one
minute left, and I like to stay within my time. Does your
agency conduct surveys?
Secretary Walsh. As far as employee surveys?
Senator Kennedy. Any surveys.
Secretary Walsh. We do, yes.
Senator Kennedy. Okay. Do you pay people?
Secretary Walsh. Pay the people who do the surveys?
Senator Kennedy. No, to take the survey.
Secretary Walsh. I actually don't know the answer to that.
Senator Kennedy. Well, here is why I am asking. And I am
not trying to----
Secretary Walsh. I will get back. I don't know. I don't
know the answer to that.
Senator Kennedy. I need your help finding something. One of
my constituents got this in the mail. It is a letter--I know it
is not under your jurisdiction--from the Bureau--Census Bureau.
And they asked him to fill out a form on children's health, and
he opened it up, and look what fell out, a five-dollar bill.
And there is no reference in the letter to the $5 in cash he
got from the Federal Government. What is this all about?
Secretary Walsh. I have no idea. I will look into----
Senator Kennedy. Can you help me find out?
Secretary Walsh. I will help you find out.
Senator Kennedy. I took the----
Secretary Walsh. I didn't get one of those letters.
Senator Kennedy. Well, I filled out my census, my survey. I
want five bucks.
Secretary Walsh. I do, too.
Senator Kennedy. And I understand that under the Biden
administration is also sending people $40 gift cards.
Secretary Walsh. I doubt that is from the Biden
administration. But I will look into it.
Senator Kennedy. I looked it up, it is on the Internet. It
must be true.
Secretary Walsh. I will look into it with you, my friend.
Senator Kennedy. Would you?
Secretary Walsh. I promise.
Senator Kennedy. Thank you, Mr. Secretary.
Secretary Walsh. All right, sir.
Senator Murray. Senator Shaheen.
IMPORTANCE OF THE JOB CORPS PROGRAM
Senator Shaheen. Well, thank you, Madam Chair.
And congratulations, Mr. Secretary, we are delighted to
have you in your current role, and it is nice to have a New
Englander who I can understand.
You were talking earlier about the need to have more
nontraditional apprenticeships, and the potential for doing
that for organizations to make that possible. One of those
organizations in New Hampshire is the Job Corps where they have
a number of training programs that train people for healthcare
roles, for dental assistants, for some of the things that have
been nontraditional.
Can you speak to the importance of the Job Corps and why it
is a great opportunity for young people who may not have
another alternative?
Secretary Walsh. Absolutely, Senator. Thank you for that.
You know, prior to my being here, I did not have, per se, a Job
Corps Center in the City of Boston, but we had lots of
workforce development programs. My first Job Corps visit was in
Memphis, Tennessee, where I got a chance to tour the Job Corps
facility there. And I saw first-hand the unbelievable potential
of creating pathways for so many young people in America.
And then I started to look into it, and realize the amount
of young people that go through Job Corps. Job Corps, there is
no question in my mind, that everybody today who brought up the
question with me so far, Job Corps should be a main stay in
Opportunity For Economic Development and Job Growth.
I think that we need to continue--I am going to continue to
partner with Job Corps. I am going to do everything I can. I
have asked for a budget increase for Job Corps. I am also going
to do everything I can to make sure that Job Corps all across
this country is successful.
I know your Job Corps in New Hampshire. I know it is
successful, and we want to take those models and make it
successful. So I am spending, you know--again not to kind of
get off the beaten path here--but I know when I became
Secretary of Labor, you know, people talk about OSHA,
unemployment insurance, and all of the--kind of the bigger
ticket items, Job Corps is as important as any of these, if we
do it right and continue to create pathways.
Senator Shaheen. Well, thank you. I worked for 20 years,
first as governor, to get that Job Corps, with a lot of other
people who supported it. So it is really nice to see it be
successful. And I appreciate the support from--your support for
Job Corps.
H-2B VISAS
Something that has not been so positive this year has been
the challenges with finding workers in New Hampshire, as
everyone has spoken to already. And one of those issues in New
Hampshire has been the access for H-2B visa workers. You and I
talked about this last spring. But we have a lot of seasonal
businesses that rely on H-2B visa workers to fill those
temporary jobs. When we don't have workers in New Hampshire who
are willing to take those jobs, and we have an unemployment
rate that is now back to under 3 percent.
Congress charged the Secretary of Homeland Security and
you, as Secretary of Labor, with the responsibility of
collaborating to determine the appropriate number of additional
H-2B visas to release for this fiscal year. I was disappointed
to see the administration's ultimate decision to release just
22,000 additional visas. And just 16,000 of those were set
aside for returning workers. They were fully applied for less
than 2 weeks after being made available.
So can you tell us how the administration determined that
22,000 number, and why only 16,000 of those should be available
for returning workers?
Secretary Walsh. Yes. I can. First and foremost, it was, as
somebody who was literally on the job about 3 weeks at that
particular moment, I sat with Secretary Mayorkas, and we were
looking at different numbers. He had a very high number--a much
higher number than that. And we were looking at the consistency
of what the past practice has been, and what the average number
of additional visas have been; 22,000--well, let me, 16,000 of
the traditional ones is about the average of the last 3 years,
not including last year, what the average was.
The 6,000 that were added was for the Northern Triangle of
Central America and Southern America. So we have made--my
office and Homeland Security's office is coming up with a
better formula for how we operate and move forward next year.
And I think that, certainly, your office, I spoke to you
directly, and Senator Hassan called me, and many Senators from
around the country called me as well, from all over the
country, really concerned about this.
We got the number out late. And so what we want to do now
is prepare for next year as we move forward so this same thing
doesn't happen. I know that in New Hampshire, Maine, and other
places, the tourism industry is in desperate need of these
workers, and other parts of the country, the fishing industry
is desperately in need of these workers.
And then we are also looking at the H-1B program as well
for the farmers. So I don't have a great answer for you, how we
came up with that number, other than we sat down and had a
compromise, a conversation. But I can tell you this: you have
my commitment that next year we will not be dealing with this
at the last minute. We will have this conversation beforehand,
and may be even an opportunity for me to visit with you and
talk to some of the workers that are in your State, to talk
about the importance of that program.
Senator Shaheen. Well, thank you very much. I appreciate
that.
ADDRESSING THE WORKFORCE SHORTAGE
And I know I am out of time, Madam Chair. But I would just
remind us all that we are dealing with an aging workforce in
this country. And if we expect to fill the jobs that we are
creating, we need to get more older workers into the workplace,
and we need to get more immigrants into the workplace. And I
understand that is a charged political issue, but it is one we
need to face if we are going to address our workforce shortage.
Thank you.
Senator Murray. Thank you.
Senator Baldwin.
Senator Baldwin. Thank you, Chair Murray.
PARTNERS ACT APPRENTICESHIP LEGISLATION
Secretary Walsh, I am going to join the chorus here as a
big supporter of apprenticeship programs. And I plan to shortly
re-introduce my apprenticeships legislation, known as the
PARTNERS Act, in the near future. That is focused particularly
on collaboration between smaller work places, and technical
colleges, and workforce Boards to sometimes create novel
apprenticeships, but to assist, especially, smaller businesses,
in standing up apprenticeship programs.
DIVERSITY IN APPRENTICESHIP PROGRAMS
Anyways, I was pleased to see that your budget requested a
$100 million increase for apprenticeship programs, along with a
commitment to increase access to apprenticeships for,
historically underrepresented groups. I wanted to call your
attention to my home State of Wisconsin, where in Milwaukee we
learned that the number of Black apprentices decreased by
nearly 22 percent over the last year. That is a deeply
disturbing statistic.
And so I am interested in learning how the Department will
use the appropriated funds to attract more racially-diverse
apprentices. And what strategies you have to prevent the sort
of numbers that we have seen in Wisconsin, and Milwaukee in
particular?
Secretary Walsh. No. Thank you. I was in Milwaukee about 3
weeks ago, or with the Mayor, and we were on a job site,
replacing lead pipes, they were replacing lead pipes in one of
the neighborhoods in Milwaukee. And prior to that I was at a
roundtable with the Building Trades, I think that there are two
things we have to do.
Number one is, I think the people that we have to--that
want to get access to these apprenticeship programs, that there
are people of color, African-American, Latino. People want to
get in. It is about, you have to be real intentional about
reaching out to the community and creating open-door
opportunities for these programs. I have done it in the city as
a head of the Building Trades. I have done it as the Mayor of
the City of Boston.
And I think that we have a unique opportunity right now in
the--you know, at the Department of Labor equity is kind of at
the core of everything that we are doing, and we need to make
sure, if we want to really come back and build back better, it
has to be built back better for all people, it cannot just be
build back better for some communities.
And so I think we--number one, to answer your question, at
the Department of Labor, when we start to think about putting
RFPs (Request for Proposals) out, we start to expand these
apprentice programs, we also have to put in some
recommendations on how, and explain to people, how do you get
people that don't have access to these programs, access.
So you just got to be intentional about it, bottom line. I
mean, in Boston, it has worked. I mean, are the numbers great?
No. Are the numbers better? Yes. So we have to be better than
we were.
IT SOLUTIONS FOR AGING UI SYSTEMS
Senator Baldwin. During the pandemic Wisconsin's Department
of Workforce Development really struggled to make timely
unemployment insurance payments because of outdated computer
systems.
Secretary Walsh. Yes.
Senator Baldwin. And they were a product of years of
neglect, and frankly, partisan attacks on the unemployment
insurance program to begin with. I am encouraged to see that
your budget will provide, again, $100 million specifically for
IT solutions that can be deployed in the State. And this money,
I think will be well spent in Wisconsin. But I was also
interested in learning more about the first comprehensive
update in decades to the formula that determines the funding
States received to administer unemployment.
Can you provide more information on the proposed changes to
the formula? And is this something that the Department expects
to undertake administratively? Or do you think you are going to
need changes to authorizing language?
Secretary Walsh. Well, first of all, thank you for bringing
this up. Because as I was prepping for this hearing, most of my
prep was about--around unemployment insurance, so I thank you
for bringing it up. I think that a lot of what we can do,
Department of Labor, is working, going to be working with
States and territories to be able to look at what investments
are needed in those different areas.
We are using the funds that--through the American Rescue
Plan to tackle the most acute problems that the systems have
been facing for a long time. There are kind of four key
priorities, which I will touch upon: one is sending teams to
States to provide intensive technical assistance that is first
and foremost, really finding out, because every State system is
a little different on how they operate, and their computer
systems are completely different. We are going to provide
States with direct assistance and experts, to learn about the
challenges, and to begin to help immediately on what we need to
do. So that is one space.
Second is a focus on ID verification, and looking in that
area. A third is modernizing technology, probably one of the
biggest things that we have an issue with is technology, and
States are running on incredibly antiquated systems that they
have had for 30, 40, 50 years; and then a direct grant to
States to help them solve the challenges that they have in the
system.
I mean, reforming the united system will do a lot. Number
one, as you mentioned at the very beginning, at the beginning
of the pandemic people had problems accessing the benefit. They
couldn't get in. They were waiting, and they were waiting on
Zoom, they were waiting in the line, they were waiting and they
couldn't get through.
So creating a platform, a system, when somebody needs
unemployment, they can either sign up online, or get a phone
call. They can get in; number one.
Number two; it is also the fraud piece of it. Lots of--
there was lots of organized crime and fraud with the UI system
where millions and billions of dollars were taken that should
have gone to people. Again, that will address the fraud.
So we are going to have a comprehensive approach moving
forward. We are being very, very, focused on how we administer
this program, and how we move forward.
Senator Baldwin. Okay. And if you can follow up with some
more information about the formula changes that are being
undertaken, that would be great.
Secretary Walsh. Yes. I will get back to you. Thank you.
Senator Murray. Thank you very much.
BUDGET INCREASES FOR WORKFORCE DEVELOPMENT PROGRAMS
Mr. Secretary, the budget request includes significant
increases in funding across the workforce development program,
and like COVID itself, the economic impacts of the pandemic
issue now have fallen disproportionally on the most vulnerable,
including women, workers with low incomes, workers of color; so
the investments in this budget would help our economic
recovery, but also address changing workforce needs that were
apparent actually long before COVID; such as the transition to
clean energy, and the development of other in-demand industries
and sectors.
Can you talk to us about why the increases in workforce
development programs are so important right now, and
specifically what this budget does to address inequities in our
workforce programs?
Secretary Walsh. Yes. Let me try and do a better job than
the first time I was asked the question. Most people here today
that have asked me a question have discussed either, the
underemployment of people, or the lack of ability to get into a
better paying job. What the pandemic--we have known this before
the pandemic--but what the pandemic has really shown is that we
are in a crossroad in our country, and we have an opportunity
to create a platform for people to get into the middle-class.
President Biden's ``Build Back Better'' plan, not the plan,
but build back better, the words ``build back better'' when he
talked about in the very beginning before there were any plans
associated with that, was about creating opportunities and
pathways into the middle-class, that people wouldn't have to
live in poverty, people wouldn't have to worry about
unemployment, people wouldn't have to worry about not having
healthcare, and child's care, daycare, education, all of that.
And what our workforce investments are--what we are asking
for in this budget, and what we want to do with our workforce
investments in the Department of Labor, in this budget, is to
continue to advance what the President's agenda is, what we all
want to do moving forward. And so for every dollar that we
spend, with all due respect to one of the Senators today, for
every dollar that we spent in workforce development, it is an
investment in the future of America's workforce. And it is an
opportunity.
Ranking Member Blunt mentioned new emerging tech--new
emerging industries, those industries right now, a lot of them,
are just for college graduates. They are going into cities like
Boston, and they are grabbing up college graduates, but they
have more opportunities than they have people to work in those
jobs. And when I--when you talk to those CEOs, and the people
that create those companies, what they say is that we can train
the workforces to work in those industries. We don't need to
have a college degree, or a Ph.D, or a law degree.
So we have a unique opportunity right now. So the
investments that I am asking this committee to support, and I
am going to be asking the Full Senate and Congress to support,
are investments we are making in the future of American
workers.
We don't want the same-old, same-old Department of Labor,
where we are going to be giving grants to States and States
will be taking the money and maybe doing something with it.
What we want to do is make sure that these investments are
going in the right places so we can continue the opportunity to
get our--your constituencies, my constituents into good-paying
jobs.
That is the opportunity in front of us at this particular
moment in time. And I think that nobody wants to go back to the
old way. I think it is important for us, we continue to make
investments in American people for those jobs.
COMBATING WAGE THEFT
Senator Murray. Okay. There are workers around the country
right now, as you well know, trying to support their families,
make ends meet, but they are being denied the unacceptable--or
the unacceptably low Federal minimum wage, overtime pay, or
both. And it is clear more needs to be done to ensure workers
received the wages that they actually earn. And it is the Wage
and Hour Division's job, as you know, to investigate these
cases and recover back wages and damages on their behalf. Can
you talk to us about how your Department would use the $30
million increase that you have requested for Wage and Hour, to
address wage theft or increased back pay recovery, particularly
for our vulnerable workers?
Secretary Walsh. Yes. First and foremost I want to--again,
I wanted to just thank you for the American Rescue Plan because
we have made some investments there as well in Wage and Hour,
and we are building back up where we were a previous--to
previous levels. The investments that we want to invest there,
again it goes back to thinking about the Department of Labor in
a different way, as far as, the way I view the Department of
Labor is we represent workers in the morning, in the afternoon,
and at night.
And we represent workers in all different levels, whether
it is security on the job site, safe retirement, and safe
working conditions. So what we want to do in Wage and Hour is
make sure that we truly make an opportunity for people that are
being shortchanged or not getting their wages that they earn
and deserve, that we have the proper opportunity for
investigation to go in and investigate any cases out there, so
we are able to follow up, and get people's back wages.
If you look at the Department of Labor's website, every day
we have another case where we are able to recoup benefits of
people that lost their money.
Senator Murray. Thank you.
Senator Blunt.
Senator Blunt. Thank you. Thank you, Chair.
ALLEVIATING LICENSING RESTRICTIONS FOR MILITARY WORKERS AND THEIR
SPOUSES
The President on Friday released an executive order that
encourages the FTC (Federal Trade Commission) to ban
unnecessary occupational licensing restrictions. I have been
particularly involved in that as it related to returning
veterans who bring skills back with them, or veteran spouses or
military spouses who are going from one State to the next. What
are you doing? And what do you think we can do to encourage
more cross-State collaboration in licensing, and to eliminate
needless barriers for licensing, particularly for those people
who in some way have either been in the military, or have
spouses in the military?
Secretary Walsh. Yes. I don't have a direct answer for you
to that question, but my past understanding of being in the
legislature, or in the City of Boston as the mayor, it is a
concern because people would come to our city and they would
want to work in a certain industry, and the license was not
recognized in the City of Boston.
And there was an ability at the State level to get a
waiver, but it is something that I don't have enough
information on, and I will look into it. But I definitely think
that, particularly military families, as military families they
are not in--I have a cousin that is in the Coast Guard. In the
last 10 years he has spent time in San Diego, up in Portland,
Maine, he has been all over the country because he gets shifted
from base to base every 3 years.
Senator Blunt. Right.
Secretary Walsh. So again, you know, if he had a career
that, a side career that had a license, he needed to get that.
So let me--I will work on that with you. I don't have the
direct answer for you on that.
Senator Blunt. Let us work on that. I think the executive
order clearly heads in the right direction, but let us work on
what we can do now. That is largely a State and a local
determination. Up until this point many of the States,
including Missouri, are moving in the direction of making it
much easier. We just, I think our first military spouse that
got an immediate license when she came to this State, was a
lawyer, who, within a few days of moving to Missouri with her
husband who was at Fort Leonard Wood was practicing law. And
the more of that sort of thing, whether it is a lawyer, or a
beautician, or an electrician, or----
Secretary Walsh. A teacher.
INCREASE IN H-2B VISAS
Senator Blunt [continuing]. A commercial truck driver,
whatever those licenses are, I want to work with you on that.
In another area, I was pleased to see the Department, in
conjunction with the Department of Homeland Security, announce
the availability of an additional 22,000 H-2B visas, provided
for in the 2021 Omnibus Bill. You know, these H-2B visas are, a
lot of them in hospitality, and landscaping, in timber.
In our State, I see those generally as jobs that actually
protect the other jobs that are there, coming in, filling a
part-time gap that allows the full-time Missouri resident
employees to have a job that they wouldn't have, if the hotel
couldn't be open, or that they wouldn't have if all of the
landscaping work that needs to be done at a given time,
couldn't be done.
I don't want a detailed answer from you here today, but I
would like you to commit to working with this subcommittee to
guarantee that the program has sufficient returning workers to
meet the seasonal needs of our small businesses, and our local
industries. And fishing would be one of those industries in
coastal areas. Senator Mikulski and I used to work closely on
this particular issue.
Would you be willing to continue to work with us on this,
Secretary?
Secretary Walsh. Yes. There is no question about that. And
not only that, I think that this program also benefits the
people that are coming here, working and taking back home, the
revenue back home to their families. And I think that that also
is a kind of a win-win for all sides. So I certainly will
continue to work with you on that.
FUNDING FOR THE APPALACHIAN AND DELTA COMMISSIONS
Senator Blunt. Another area I mentioned in my opening
comments was that your budget request included a $35 million
set aside to serve workers in the Appalachian and Lower
Mississippi Delta regions, that we began funding in 2018. I was
the Chairman of the committee at the time, and Senator Murray
was the ranking member, and that funding has created, and will
create employment opportunities by providing reemployment and
training assistance in areas where they are needed.
Can you speak to the success of the grants in this area,
these regional commissions, like the Appalachian Regional
Commission, and the Delta Regional Commission?
Secretary Walsh. Certainly. I mean, there is no question
that these grants are beneficial to those areas of the country
and, you know, I hear, the feedback I get from the Department
of Labor, from the workforce development side of it, is that a
lot of these different areas want increased grants, and
opportunity to access to grants. So it is beneficial. And that
is why the additional revenue that I am looking for in some of
this workforce development and grant money will allow us the
opportunity to make more investments in those areas.
Senator Blunt. Thank you, Secretary.
Chair, I think that I will have some more questions for the
record. But I believe those are, at this point, at least all
the questions I have for the hearing today.
Senator Murray. Very good.
Senator Braun.
OSHA ENFORCEMENT BUDGET INCREASE
Senator Braun. Thank you, Madam Chair.
And good to see you, Mr. Secretary, enjoyed our
conversations in the past. And, you know, I come from the
business world, and especially small business, and I have been
able to see our business grow over the years, and interface
with all the things you have to do with government. And I have
always felt an inherent responsibility to do things right, keep
your employees safe, that that is part and parcel of growing an
enterprise.
I noticed where there is a request for $350 million
increase in enforcement funding, and would be curious, I tried
to get the information what that is on top of already, and is
it related to. I know maybe during the Trump administration,
which I welcomed, a lot of easing up on certain stuff that
maybe was in overdrive, still acknowledging that many things
need to be in place to keep a safe environment, to keep a safe
workplace.
Has there been an uptick in OSHA-related cases that would
warrant that kind of increase that would be targeted towards
enforcement?
Secretary Walsh. That is a great question. The problem we
have with OSHA is that we have seen an increase in cases, and
we have also seen a decrease in OSHA inspectors. So I guess the
answer is: that we are seeing increased potential problems, and
we have fewer people to go out and investigate those problems.
So we have a lot of our cases that are going kind of, I guess,
unchecked, if you will.
Again, as I said earlier, before you came in Senator, this,
I would like to get OSHA to a point where it is not just going
out and seen as a ``gotcha'' organization. I mentioned, when I
was a younger person, I worked on construction, and OSHA would
come out to the job site, and not because they are out there
because of an accident, they are out there to make sure that
there was proper safety procedures in place in construction,
which is dangerous, as you know.
I would like to get OSHA back where we are doing a lot more
collaboration of working with businesses to make sure we create
work--safe work sites across America, rather than having to
respond to a tragedy. And we are not there yet. So the increase
that we are looking for is to build back the OSHA Department,
and build back the Department of Labor to pre--you know, the
last 5 years we are down, the lowest amount of inspectors, I
believe, in the history since the beginning of the Department
of Labor, we are at the lowest number right now.
Senator Braun. So what I would like, and you can get that
to our office, would be: what the number of enforcement issues
have been from 5 years ago to the present, what the funding
levels were each year, to make sure it might get related to
that in some fashion.
OSHA ENFORCEMENT IN LARGE BUSINESS VS. SMALL BUSINESS
And then also I would want to bring up the distinction
between large business and small business. And NFIB (National
Federation of Independent Business Inc.) has been out there
with so many stats that have shown that small businesses have
been decimated, challenged with COVID, some of the things they
had to do there that was on top of what they have to normally
do to move forward and prosper. And I have also been an
observer there. The smaller your business is, normally, the
more intimate that relationship is with your employees.
So again, I would like to know whether the Department
currently differentiates between how it looks at enforcement
among big businesses versus small businesses. And to see if
there is a distinction in how you carry out those functions.
Secretary Walsh. Yes. Let me get back to you on that one. I
don't have the answer for you.
Senator Braun. Yes.
Secretary Walsh. But I understand here what you are saying.
And when you talk about small businesses, you are not
necessarily talking about the three-person mom-and-pop store,
you are talking about the 200-person store and----
Senator Braun. I would give it 500 and fewer.
Secretary Walsh. Yes.
Senator Braun. And it is that----
Secretary Walsh. So let me get back to you on that.
Senator Braun. Yes.
Secretary Walsh. Because I understand, I recognize the fact
that there is a big difference between a small business and a
corporation.
Senator Braun. Especially 50 and under.
Secretary Walsh. Yes.
Senator Braun. But let us take the common definition, and
whatever is being done in the future, I would want to make sure
it is based upon the need to do it, number one, especially in
the context of scarce resources. So much of what we are doing
today and not just after the Biden administration took over,
because we do it on borrowed money on anything that we do
enhance in a budget. And I think that will come into question
in the long run as well.
So if you could get back to my office on those two
particular pieces of information, I would appreciate it.
Secretary Walsh. I definitely will.
And I was at the Indy 500 the other day, I went around the
track, it was pretty amazing.
Senator Braun. Yes. And that is a kind of, I guess, a big
version of a small business.
Secretary Walsh. Yes. It certainly is.
Senator Braun. Right in my home State.
Secretary Walsh. It certainly is. It was interesting. It
was fun.
Senator Braun. Yes. Okay. Thank you.
Secretary Walsh. Thank you, Senator.
Senator Murray. Thank you very much.
That will end our hearing today, Mr. Secretary; and our
hearings on President Biden's Budget Proposal for fiscal year
2022.
I want to thank all of our fellow committee members for
their participation.
Secretary Walsh, thank you for your very thoughtful
answers. I look forward to continuing to work together with you
to fight for workers, and build a stronger, fair economy for
everyone.
ADDITIONAL COMMITTEE QUESTIONS
For any Senators who wish to ask additional questions,
questions for the record will be due Friday, July 23 at 5 p.m.
The hearing record will also remain open until then for members
who wish to submit additional materials for the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted to Hon. Martin J. Walsh
Questions Submitted by Senator Patty Murray
whistleblower complaints and staffing
Question. I'd like to follow-up on my question about OSHA's
whistleblower program. Last year's Inspector General report described
the significant increase in complaints and insufficient staff to
investigate those complaints during the pandemic.
Please describe the impact of complaints not being timely and
effectively investigated and the steps planned and being taken to
address this issue.
Answer. Over the past several years, OSHA has experienced a
significant increase in new whistleblower complaints being filed, while
the level of staffing has remained steady. This, coupled with new
whistleblower statutes added to the agency's growing portfolio,
including statutes unrelated to worker safety and health, has resulted
in a significant increase in the inventory of outstanding
investigations, with many going on for extended periods of time
(overage/backlog cases). These factors have created a lag time in
completing investigations and making agency determinations based on the
merits of the complainants' allegations. With the onset of the
coronavirus pandemic (with more than 5,500 COVID-19-related
whistleblower complaints filed so far), the additional increase in new
filings and subsequent backlog inventory have limited the agency's
ability to complete investigations in a timely manner. If OSHA does not
have sufficient resources to meet quality and efficiency standards for
its whistleblower investigations, and is unable to review all
complaints alleging workplace retaliation, the agency cannot properly
protect employees' rights to engage in protected activity and prevent
retaliation.
OSHA has taken many steps to address the challenge of achieving a
reasonable balance between an investigation's timeliness and quality in
order to handle its whistleblower inventory more efficiently and
effectively. First, the agency instituted a pilot program whereby the
agency conducted two rounds of assignments of complaints across
regional boundaries, allowing for regions with a lesser workload to
assist regions with a higher workload, focusing on establishing a more
reasonable workload balance nationwide. OSHA is actively exploring
other avenues to address backlogged inventory, both nationally and
regionally. Second, the agency is overhauling the Whistleblower
Investigations Manual (WIM) to streamline procedures without
compromising case quality. OSHA instituted a new Pilots Directive that
allows for innovative ideas and suggestions to be `tested' to see if
added efficiency is gained and successful pilots are incorporated into
the WIM and made national policy. Third, OSHA developed an
investigative checklist to ensure that key investigative steps are
followed, establishing clear and effective case monitoring during the
final stages of an investigation, and thus ensuring that the quality of
the investigation is maintained. Finally, OSHA is actively hiring
additional whistleblower staff to assist not only in addressing the
inventory of backlogged cases but also the total inventory of cases, by
promptly processing and investigating new complaints so they don't
become overaged. The agency's fiscal year 2022 budget request also
includes a requested increase 63 FTE and $5.3 million to provide
additional whistleblower staff to meet the workload demands.
OSHA will also continue to engage its stakeholders with meetings
throughout the year. These meetings provide a forum for the public to
offer suggestions and comments on ways the agency can improve the
whistleblower program. This will allow OSHA an opportunity to go beyond
the protection of individual whistleblowers by increasing outreach
efforts through the Whistleblower Outreach Plan in an effort to educate
employers about their responsibilities and employees on their rights
afforded under the statutes OSHA enforces. The agency will focus its
outreach efforts on industries with the highest, as well as the fewest
number of complaints filed, whistleblower protection provisions of the
newest statutes enacted, and vulnerable populations least aware of
worker protections while also continuing to promote the ``Recommended
Practices for Anti-Retaliation Programs'' guidance for employers. This
document outlines the steps recommended for employers to establish a
workplace where employees feel comfortable raising concerns, without
fear of retaliation. In turn, the employer benefits from improved
employee morale and productivity, as well as the likelihood of fewer
whistleblower complaints being filed by its workers.
Question. How would the American Rescue Plan Act funds, additional
funds requested in the fiscal year 2022 budget and policy changes
address a recommendations made by the Office of Inspector General to
more equitably distribute whistleblower complaints amongst
investigators, and provide consistent enforcement of whistleblower
rights among the regions.
Answer. OSHA will use the funding received under the American
Rescue Plan Act to address COVID-19 related whistleblower complaints.
OSHA published the COVID-19 National Emphasis Program, which
prioritizes investigating employers that retaliate against workers for
complaints about unsafe or unhealthy conditions, or for exercising
other rights protected by Federal law. OSHA plans to spend $13,079,000
to support 32 FTE in the Whistleblower budget activity, including 25
investigators over the course of the three-year supplemental. Funding
would also support seven national and regional whistleblower staff to
address evolving policy issues, and provide required high level review
of the growing number COVID-19 retaliation claims received by the
agency, with more than 5,500 COVID-19-related whistleblower complaints
filed so far.
In fiscal year 2022, OSHA is requesting $24,999,000 and 185 FTE,
which includes a program increase $4,100,000 and 50 FTE for
whistleblower investigators to effectively enforce 25 whistleblower
statutes, including the recently added Criminal Antitrust Anti-
Retaliation Act and the Anti-Money Laundering Act. In addition to
investigators, OSHA is requesting a program increase of $1,243,000 and
13 FTE to support the Alternative Dispute Resolution (ADR) Program,
policy development and review, and appropriate management support for
the Whistleblower Protection Program (WPP). As part of the effort to
build a stronger whistleblower program and have the necessary level of
resources to support the significant number of whistleblower statutes
the agency has been mandated to enforce, OSHA will make sure that every
worker, especially those in vulnerable and underserved communities,
knows about their rights and what to do if they believe their safety
and health is not being protected. The agency is committed to ensuring
that every worker is protected and feels empowered to raise concerns
when they feel their workplaces are unsafe.
The additional investigators requested in fiscal year 2022 will be
distributed throughout the agency's regional offices with a focus on
preventing an increase in the backlog of complaint investigations while
also reducing the overall inventory of pending investigations. The
requested resources will help OSHA keep up with the high demand, and
ensure that workers' concerns are properly and thoroughly processed and
responded to as expeditiously as possible.
OSHA has taken many steps to address this challenge of achieving a
reasonable balance between an investigation's timeliness and quality in
order to handle its whistleblower inventory more efficiently and
effectively. First, the agency instituted a pilot program whereby the
agency conducted two rounds of assignments of complaints across
regional boundaries, allowing for regions with a lesser workload to
assist regions with a higher workload, again, focusing on establishing
a more reasonable workload balance nationwide. OSHA is actively
exploring other avenues to address backlogged inventory, both
nationally and individually by Region. Second, the agency is
overhauling the Whistleblower Investigations Manual (WIM) to streamline
procedures without compromising case quality. OSHA has instituted a new
Pilots Directive that allows for innovative ideas and suggestions to be
`tested' to see if added efficiency is gained--those successful pilots
are incorporated into the WIM and made national policy. Third, OSHA
developed an investigative checklist to ensure that key investigative
steps are followed, establishing clear and effective case monitoring
during the final stages of an investigation, and thus ensuring that the
quality of the investigation is maintained. Lastly, the agency is
actively hiring additional staff to assist not only in addressing the
inventory of backlogged cases but also the total inventory of cases, by
promptly processing and investigating new complaints so they don't
become overaged.
In addition, with new fully trained staff in place, along with new
staff requested in the fiscal year 2022 Budget Request, OSHA will
continue to streamline its processes by developing alternative
procedures through piloted programs and strategies that are evaluated,
found to be effective, and implemented nationwide. Specific focus will
continue to be placed on backlog reduction strategies to reduce the
inventory of overaged cases. Additionally, OSHA will continue its
efforts to expand the use of the Alternative Dispute Resolution (ADR)
Program, which has proven to be an effective strategy to efficiently
process complaints/cases in a timely manner and with positive results.
With the delegation of two additional whistleblower laws in fiscal year
2021, the Anti-Money Laundering Act (AMLA) and the Criminal Antitrust
Anti-Retaliation Act (CAARA), OSHA plans to conduct training on the
investigative processes concerning these new laws for its staff in
fiscal year 2022, as done with the Taxpayer First Act (TFA) in fiscal
year 2020. OSHA also plans to develop an Intranet-based Whistleblower
Investigator (WBI) Resource Page for whistleblower personnel that will
include technical assistance and answer a myriad of questions presented
by the field, including those related to COVID-19, which is constantly
evolving. This will be accessible to all Regions, ensuring nationwide
consistency. All of the initiatives will be developed and implemented
to assist the agency in addressing the recommendations made by the
Office of the Inspector General.
davis bacon enforcement
Question. Mr. Secretary, construction workers across this nation
rely on the Department's Wage and Hour Division to enforce their right
to prevailing wages on federally assisted construction projects. As a
former construction worker, you know as well as anyone that
construction is hard, dangerous work. These protections ensure the
Federal Government is creating good jobs with fair pay and bringing
countless economic benefits to local communities. The workers and
communities who build our bridges, highways, and other critical
infrastructure deserve the protections and the benefits prevailing wage
provides.
Mr. Secretary--how would your Department use the funds requested
for the Wage and Hour Division to better enforce the Davis-Bacon Act,
particularly with respect to working with other Federal agencies to
ensure compliance?
Answer. The Davis Bacon Act protects construction workers' rights
to receive the local prevailing wage and leverages the purchasing power
of the Federal Government to support local contractors, local workers,
and local economies. The Department is currently engaged in a
comprehensive review of its Davis Bacon program including outreach,
education, compliance assistance in partnerships with contracting
agencies and enforcement. Additional enforcement resources will allow
the Wage and Hour Division to put more investigators into the field and
onto construction sites to make sure workers are getting the wages they
have earned on Davis Bacon projects.
ilab monitoring and enforcement
Question. Mr. Secretary, my home state of Washington is one of the
most trade dependent economies in the United States. That's one of the
reasons I support trade deals with strong labor and environmental
protections. So, I was pleased to see the budget proposes $124 million,
an increase of more than $27 million, for the International Labor
Affairs Bureau. This includes significant new investments for ILAB to
expand trade-related monitoring and enforcement of labor provisions in
our trade programs and new resources to investigate the use of forced
and child labor in global supply chains.
I know you have dedicated resources for work on our trade agreement
with Mexico and Canada. However, with 150 international trading
partners under existing free trade agreements or trade preferences,
your budget request won't stretch far enough to conduct monitoring and
enforcement with all of our trading partners.
How will you prioritize countries for monitoring and enforcement
activities?
Answer. DOL is committed to monitoring and enforcing the labor
provisions in all of our trade agreements and preference programs. Over
the last year, in addition to creating a new division dedicated to
enforcing the labor provisions of the U.S.-Mexico-Canada Free Trade
Agreement, our Office of Trade and Labor Affairs (OTLA) within the
Bureau of International Labor Affairs has increased the staffing level
and resources devoted to enforcing labor provisions in the other trade
agreements and trade programs as well. This has enabled us to intensify
our engagement with countries with the greatest need. For example, so
far in 2021, the Department has dramatically increased its work
allocated to our trade agreement with Central America (CAFTA-DR),
enabling us to integrate labor enforcement into the important work
being led by the White House on Central America. Likewise, with the
preference programs, we are continuing to monitor all countries
benefiting from the Generalized System of Preferences (GSP) and the
African Growth and Opportunity Act (AGOA) through the GSP triennial
assessment and the annual AGOA review. Based on these processes, our
team prioritizes and engages with key countries in an ongoing manner.
Both the GSP and AGOA processes consider information from a broad array
of sources, including U.S. government reporting, international and
national labor rights organizations, and public comment mechanisms
included in the preference programs. Our team shares the results of its
fact-finding, along with recommendations for priority countries, with
the Trade Policy Staff Committee (TPSC). Subsequent discussions with
interagency partners further shape OTLA's identification of priority
countries and inform ongoing strategies for engagement to promote
progress towards meeting the worker rights eligibility criteria.
Question. And, how will you partner with the State Department and
Office of the Trade Representative to ensure the most robust
enforcement possible of labor provisions in our trade programs?
Answer. DOL works closely with the Department of State and the
Office of the U.S. Trade Representative (USTR) in our goal for strong
enforcement of labor provisions in our trade agreements and trade
preference programs. DOL engages with key countries through bilateral
work and is in constant communication with our interagency partners,
trade partner country stakeholders, and the International Labor
Organization to maximize our effectiveness in labor enforcement. In
addition, DOL works with State and USTR in a variety of formal
mechanisms, such as the Trade Policy Staff Committee (TPSC), labor and
trade-related working groups such as the CAFTA-DR working groups, and
Trade and Investment Framework Agreements (TIFAs). For example, DOL's
Office of Trade and Labor Affairs (OTLA) collaborates with USTR's labor
office to develop and deliver talking points on labor priorities in
connection with TIFAs between the U.S. and parties to the TIFA. OTLA
also convenes regular calls with USTR and State to discuss and share
updates on priority labor issues, and ensures USTR and State's
participation on relevant labor-related country briefings.
child labor
Question. According to the latest report on child labor produced by
the International Labour Organization and UNICEF, the number of
children in child labor around the world dropped from 246 million in
2000 to 152 million in 2016. Unfortunately, this 16-year downward trend
has been reversed over the past 4 years, increasing to 160 million
children worldwide in 2020 with nearly half of these children engaged
in hazardous work.
Please describe how funds currently available to the International
Labor Affairs Bureau will be used to contribute to a reversal of this
increase in child labor.
Answer. Reversing the upward trend in child labor, as reported in
the latest ILO and UNICEF global estimates, will require a multi-
faceted approach. A range of factors have contributed to the
significant increase in child labor noted in some parts of the world,
particularly Sub-Saharan Africa. ILAB is increasing its focus on a
number of key areas where there is a great need and where we can have a
significant impact. This includes increased focus on global supply
chains; promoting greater access to social protection, training, and
education opportunities for vulnerable children and families;
confronting gender and racial inequity; and strengthening worker voice
and workers' rights.
ILAB's Office of Child Labor, Forced Labor and Human Trafficking is
currently overseeing 46 projects with activities in over 40 countries.
These projects are addressing root causes of child labor and forced
labor through research, awareness raising, education, improved
livelihoods, strengthening labor laws and enforcement, and by
increasing the capacity of governments and other stakeholders to scale
up and sustain effective practices for preventing and reducing these
abusive labor practices. ILAB has also worked with these existing
grantees to address urgent needs resulting from the global pandemic.
ILAB has allocated project resources to increase vulnerable groups'
access to information about the virus, address food insecurity, support
remote education and training, and provide masks and hygiene resources
to reduce exposure of vulnerable children and workers. ILAB is also
deeply engaged in addressing child labor and forced labor in Sub-
Saharan Africa, with over $40 million in active programming in the
region, including more than $18 million in new programming awarded in
2020 addressing child labor in key supply chains such as cobalt, cocoa,
and mica. These projects include a focus on issues of gender equity and
the need for enhanced monitoring and remediation. With fiscal year 2021
funds, ILAB is also currently in the process of funding new projects
that will address some of the key gaps identified in the ILO-UNICEF
report. For example:
--In Malaysia, ILAB is funding a $5 million project to combat forced
labor and child labor by increasing advocacy by workers and
civil society in the production of palm oil and garments,
worker voice in the implementation of a social compliance
systems, and workers access to remedies in these sectors.
--In El Salvador, Guatemala, and Honduras, a $7 million ILAB-funded
project will build civil society and workers organization
capacity to address child and forced labor and other
unacceptable conditions of work, promote greater gender and
racial equity, and address the needs of some of the most
vulnerable populations in these countries, including persons of
African descent and indigenous communities.
Moreover, as part of our efforts to achieve a larger and more
sustainable reduction in child labor and forced labor, ILAB will
actively engage with governments, the private sector, worker
organizations, civil society actors, other donor governments, and
international organizations to promote the replication of effective
practices. ILAB will call on governments to mainstream child and forced
labor elimination strategies into broader social initiatives as a way
to take to scale strategies that can help to reduce the vulnerability
of children, families, and workers to abusive labor practices. ILAB
will also continue to use its flagship reports on child labor and
forced labor to urge governments to take specific action to reduce
these abusive labor practices.
Question. How would resources requested in the fiscal year 2022
budget build on and learn from prior investments?
Answer. From more than 25 years of experience funding international
child labor projects and contributing to significant strides in the
fight against child labor, we have learned that our most successful and
impactful initiatives are those that adopt a holistic approach, based
on a broader rights-based ecosystem that places workers and vulnerable
communities at the center. We have also learned that it is critical to
create the right incentives for governments and businesses to take
actions to address child labor and forced labor, particularly in global
supply chains.
In fiscal year 2022, ILAB will focus its programming on addressing
the persistence of abusive labor practices in supply chains, including
through the funding of research to trace goods through supply chains
and targeted action to increase workers' voice in the monitoring of
labor rights abuses. Rigorous research and reporting can help us hold
both governments and corporations accountable for goods produced by
forced labor and child labor throughout the supply chain. We will also
support projects that help address decent work gaps, as child labor
tends to persist where adult workers cannot exercise their rights at
the workplace, especially the rights of freedom of association and
collective bargaining. Another critical element of ILAB's approach will
be to promote good practices and the expansion of social protection
schemes that build social safety nets for vulnerable communities where
labor abuses are most prevalent (e.g., in rural areas, in agricultural
sectors). ILAB will also increase support for workers in informal
sectors, where vulnerability to labor exploitation is more pronounced,
as noted in the new ILO-UNICEF global child labor estimates, including
through support for informal worker organizations. ILAB's increased
focus in these areas will be particularly important in addressing the
significant increase in child labor in Sub-Saharan Africa, as well as
the persistence of child labor in other parts of the world. Finally,
ILAB will partner with other donors and organizations to leverage our
resources and experience and support our goal for the replication and
scaling up of good practices to achieve the broader impact needed.
ILAB will continue to use evidence to inform action, drawing upon
our own research and reporting on forced and child labor as well as
lessons learned from past and current projects. ILAB's research serves
as an essential knowledge base for ILAB's technical cooperation
projects, helping ILAB focus its technical assistance in areas where it
is most needed and where it can have the greatest impact. ILAB also
relies on external evaluations of our projects, which systematically
assess the relative effectiveness of different approaches or
combination of approaches. ILAB uses good practices, identified through
project experience and project evaluations, as a way to leverage
learning to promote greater impact in the countries where we work. The
following are just a few examples of the impact of ILAB's strategic
approach:
--In Uzbekistan, our strategy of consistent, multi-year diplomatic
engagement coupled with programming on a broad labor rights/
decent work agenda helped achieve a radical reduction in the
country's use of forced labor in the cotton sector;
--In Honduras, we have used a multidisciplinary approach--research on
labor issues, monitoring, and technical assistance and
cooperation--to holistically and sustainably advance labor
rights, including child labor, freedom of association,
collective bargaining, minimum wages, hours of work, and
occupational safety and health (OSH). With support from an
ILAB's project, three Honduran cooperatives that export coffee
to the United States implemented a sustainable social
compliance system to reduce the prevalence of child labor in
their supply chain.
--In Mexico, we have focused research and technical assistance
efforts in the agriculture sector and on goods where there is
high risk of child labor, forced labor, and other labor
violations. ILAB has used strategic engagement to empower
workers and civil society organizations to advocate for
increased access to education and social protection services
for children at risk of child labor, their families, and
migrant workers.
Question. What are the specific plans to address the worst forms of
child labor in the cocoa supply chain in West Africa and build on prior
investments made toward this objective?
Answer. The recent release of the ILAB-funded, NORC (formerly the
National Opinion Research Center at the University of Chicago) report
on child labor in cocoa-growing areas of Cote d'Ivoire and Ghana
underscores the significant challenges remaining in the sector. ILAB
recognizes that moving toward large-scale reduction of child labor in
the cocoa supply chain will require securing a commitment to broader
action by the two West African governments and the International
Chocolate and Cocoa Industry, including to improve labor monitoring,
better regulate the sector, and expand remediation efforts. Current
ILAB programming is supporting efforts to build the capacity of cocoa
cooperatives to enhance child labor monitoring in the cocoa supply
chain and facilitate enforcement of child labor laws. ILAB is also
funding programming to help law enforcement, private sector due
diligence monitors, social service and civil society organizations, and
workers themselves to prevent, detect, and eliminate forced labor and
labor trafficking in supply chains.
During the most recent meeting of the Child Labor Cocoa
Coordinating Group (CLCCG)--a group established in 2010 under the
Declaration and Framework-- in May 2021, the Governments of Cote
d'Ivoire and Ghana, the International Chocolate and Cocoa Industry and
ILAB agreed on the need to continue to coordinate on joint efforts to
reduce child labor in the cocoa sector. ILAB is currently engaged in
dialogue with the two governments and industry on ways to (1) expand
this partnership to include other donor governments (e.g., the E.U.)
and organizations; (2) promote more active engagement with worker
organizations and civil society actors; (3) expand the scope of efforts
to include a greater focus on forced labor and human trafficking and
the advancement of decent work; (4) take good practices to scale and
increase support to children and families in more remote areas where
NORC research found the most significant increase in child labor; and
(5) increase transparency and develop and report more regularly on
indicators of progress.
ILAB will also continue to report on child labor and forced labor
in Cote d'Ivoire and Ghana in its three flagship reports--the Findings
on the Worst Forms of Child Labor, the List of Goods Produced by Child
Labor or Forced Labor, and the List of Products Produced by Forced or
Indentured Child Labor. In addition, ILAB continues to engage in active
dialogue with other U.S. government agencies, such as the State
Department, USAID, USDA, MCC, and DHS/CBP on efforts to combat child
and forced labor in the cocoa sector and potential opportunities for
enhancing interagency coordination and collaboration.
ofccp enforcement
Question. Mr. Secretary, the Department of Labor plays a unique and
vital role in Federal contracting policy through the Office of Federal
Contract Compliance Programs to protect workers' rights on jobs created
by Federal contracting. These critical protections ensure the Federal
Government is creating a fair and safe workplace when it does business
with the private-sector. And I'm pleased to see that the Biden
Administration has placed such a substantial emphasis on these
protections, including a guarantee of a $15 an hour minimum wage.
Mr. Secretary--how would your Department use the funds requested
for OFCCP to vigorously enforce anti-discrimination, safety, pay, and
other important protections for workers on Federal contracts?
Answer. OFCCP would use the $140,732,000 in funds requested for
fiscal year 2022 to rebuild its workforce, strengthen its enforcement
to remove systemic barriers to equal opportunity, advance workplace
equity, increase contractor accountability, and invest in its
technological infrastructure. An investment of critically needed
resources will enable OFCCP to play a powerful role in advancing
President Biden's commitment to equity by addressing employment
inequities that have denied opportunities to vulnerable workers.
Rebuilding Workforce
The fiscal year 2022 OFCCP funding request is $140,732,000 and 639
FTE. This includes a program increase in the amount of $34,756,000 and
188 FTE to rebuild OFCCP's workforce. Over the past 4 years, OFCCP's
staffing levels have dropped significantly. In fiscal year 2020, OFCCP
operated with a staffing level of 452 full-time equivalents (FTE)
compared to 755 in fiscal year 2011.
Strengthening Enforcement
Specifically, the agency will focus on identifying ways to
strategically allocate our limited resources on comprehensive
compliance evaluations that identify and remedy systemic issues
including in hiring and pay, especially as our economy begins to
rebuild. Our approach has often been data driven to identify
disparities, but OFCCP is interested in developing strategic approaches
to identify issues that do not lend themselves to the same kinds of
statistical analysis, such as discrimination against workers with
disabilities and LGBTQ+ workers.
OFCCP will also focus on reinvigorating its compliance program for
Federal construction contractors and subcontractors and federally
assisted construction contractors and subcontractors. This effort will
be instrumental for the Department to ensure equal employment
opportunity for good jobs in the construction industry. OFCCP plans to
launch an outreach and education campaign to advance equity in
construction contractor workplaces and to educate workers of their
rights under the mandates enforced by OFCCP.
On its regulatory agenda, OFCCP listed its intention to modernize
its supply and service regulations. OFCCP is interested in updating its
requirements to align them with the realities of today's workforce and
how employers operate. The agency is considering how it can streamline
its processes and reduce unnecessary burdens on contractors while
ensuring OFCCP can comprehensively address indicators of discrimination
across all its authorities.
Workplace Equity Initiative
The funding request would support OFCCP developing a comprehensive
initiative to advance all forms of equity at work. President Biden has
made a historic commitment to advancing equity, prioritizing it as a
key pillar of his Administration. OFCCP has a critical opportunity to
work with a broad coalition of stakeholders in the pursuit of a common
goal--to eliminate discrimination in the workplace and proactively
advance equality of opportunity for all workers, including women,
people of color, LGBTQ people, people with disabilities, veterans, and
people belonging to multiple protected classes.
The purpose of this initiative is to identify promising practices,
evidenced-based research, and innovative initiatives that can lead to
more diverse, equitable, and inclusive workplaces that increase equity
in employment opportunities. In particular, the initiative will focus
on examining employment practices that have been effective in closing
pay gaps, increasing the recruitment and hiring of underrepresented
workers, and facilitating the promotion of underrepresented workers
into senior-level and executive positions.
Technology Modernization
In fiscal year 2022, OFCCP will continue to prioritize expediting
the modernization of its technology to promote greater employer
compliance while maximizing the efficiency of agency staff. This
includes completing OFCCP's Compliance Management System (CMS)
development and deploying the Notification Construction Award Portal
(NCAP), which allows Federal procurement officers, States, and
construction contractors and subcontractors to electronically notify
OFCCP of constructions awards valued at $10,000 or more. This IT
modernization effort centralizes the notification process in the
national office, increasing field efficiencies by relieving staff from
having to manage contract award notifications
Question. Please describe your hiring plans for the proposed
investments in OFCCP included in your budget request.
Answer. This funding request specifically supports the hiring,
retention, and training of a highly qualified and diverse workforce to
support OFCCP in advancing its mission through enforcement, outreach
and education, stakeholder engagement, and compliance assistance while
emphasizing efficiency, productivity, and accountability throughout the
organization. The support for additional staff will enable OFCCP to
strengthen its capacity to conduct compliance evaluations, and identify
and resolve instances of systemic discrimination in hiring and pay.
OFCCP is actively hiring to fill critical vacancies the agency lost
over the course of several years, especially compliance officers. OFCCP
is strengthening its internal capacity to support the hiring surge by
filling the vacant HR Branch Chief position and hiring additional
management analysts to support the agency's hiring and employee
engagement needs. To expedite the hiring process, OFCCP is utilizing
standardized position descriptions, single vacancy announcements for
multiple positions at various locations, and an array of hiring
authorities, including the Recent Graduate authority for entry level
positions. In addition, OFCCP encourages its employees to share
announcements through their professional and social networks. OFCCP is
also working with OHR to reach a diverse talent pool for its vacancy
announcements.
OFCCP is developing several new training courses and resources for
its compliance officers. With the recent OMB approval of the
construction scheduling letter and the upcoming release of the
construction scheduling list, OFCCP will ensure that its compliance
officers are fully trained to handle construction compliance
evaluations in the most efficient and effective manner. This training
is scheduled to commence prior to the release of the scheduling list.
OFCCP is also developing training for new compliance officers. The
training will cover the foundational topics a new compliance officer
must know in order to successfully start performing their job, such as
relevant legal authorities, policies, enforcement authorities,
compliance evaluations, complaint processing, and compliance
assistance. This training will be ongoing for all cohorts of new
compliance officers as the agency continues to hire.
The training OFCCP provides to its compliance officers allows them
to communicate agency standards and processes through compliance
assistance and apply those standards and processes during compliance
evaluations and complaint investigations. A uniform training program
ensures consistency in training across the regional offices, which is
critical in following OFCCP's regulations, processes, and procedures
and carrying out the agency's mission. OFCCP will continue to
prioritize investing in compliance officer training as the agency
rebuilds and hires.
osha farmworker safety
Question. Under a longstanding appropriations rider of more than 40
years, farms with fewer than 10 employees at all times during the prior
year and no temporary labor camp within the previous 12 months are
exempt from enforcement of all rules and requirements of the
Occupational Safety and Health Act. Yet, according to the National
Institute of Occupational Safety and Health, agriculture ranks as one
of the most dangerous industries, with farmers at a very high risk for
fatal or non-fatal injuries. Any worksite fatality is unacceptable and
every step must be taken to avoid such tragic loss of life.
How would the Occupational Safety and Health Administration (OSHA)
use Federal funds to improve farmworker safety if Congress removed this
rider in the fiscal year 2022 appropriations bill for the Department of
Labor? Please describe compliance assistance it would undertake, as
well as how farms would be factored into planned enforcement
activities, including any emphasis programs or directives.
Answer. The existing appropriations rider has precluded OSHA from
conducting enforcement activities at a farming operation if it: (1)
employs 10 or fewer non-family member employees currently and all times
during the preceding twelve months and (2) has not had an active
temporary labor camp during the preceding twelve months. If Congress
removes the rider, OSHA can respond to imminent danger situations at
currently exempt farming operations and remove employees from those
dangers. The agency would also be able to respond to employee
complaints regarding workplace safety and health hazards, and
investigate fatalities (such as from grain engulfment) and severe
injuries. Lastly, OSHA would include small farming operations in
programmed or planned inspections, such as national, regional, and
local emphasis programs, that are aimed at specific high-hazard
industries.
While the appropriations rider has significant implications for
OSHA's enforcement activity, it should first be noted that it has not
prevented the agency from developing and distributing workplace safety
and health resources for agricultural settings, including those where
OSHA is unable to conduct enforcement. For example, OSHA maintains an
Agricultural Operations Safety and Health Topics Page with information
about hazards related to grain bins and silos, hazard communication of
chemicals, noise, musculoskeletal injuries, heat, and others. OSHA also
has a plethora of publications in both English and Spanish that are
relevant to agricultural operations that may be printed from the
agency's website directly or ordered free of charge from our
Publications Office.
The agency also conducts significant outreach to the agricultural
industry as a whole, and engages with agricultural industry
stakeholders whose target audiences include small agricultural
workplaces and family-operated farms. For example, following a
significant increase in fatal grain engulfments between fiscal year
2015 and fiscal year 2016, OSHA's Regions 5, 6, 7, and 8 launched a
``Stand-Up for Grain Engulfment Prevention'' event in fiscal year 2017.
That same year, OSHA signed an Alliance with the National Grain and
Feed Association, which helped to expand the Grain Stand-Up. Two
additional organizations, the Grain Elevator and Processing Society
(GEAPS) and Grain Handling Safety Coalition (GHSC), have since joined
the Alliance and lent their resources to expanding this initiative.
GHSC, in particular, has played a key role in ensuring the Grain Stand-
Up reaches smaller growers/producers over which OSHA does not have
jurisdiction.
If the rider were removed, and funds became available, OSHA could
greatly expand its outreach to smaller agricultural employers and
workers. Staff could pursue new relationships with Federal and state
farm associations, and proactively establish alliances for the express
purpose of conducting outreach, developing educational materials, and
providing workplace safety and health training opportunities to smaller
farm owners, operators, and employees. Removal of the rider would also
enable OSHA to expand its On-Site Consultation Program to provide no-
cost workplace safety and health services to smaller agricultural
operations who were previously not eligible for these services.
Information collected during OSHA's inspections (e.g., regarding types
and location of fatalities in smaller farm operations) could also be
used to strengthen, and more effectively target, outreach and
compliance assistance.
Question. How would OSHA use Federal funds to improve farmworker
safety if Congress were instead to modify the rider by allowing the
fiscal year 2022 appropriation to be used only to investigate
fatalities on such small farms and provide associated compliance
assistance necessary to decrease the likelihood of a similar injury or
fatality?
Answer. Farming operations experience workplace fatalities from a
variety of hazards, including from grain engulfment, falls from
structures, entanglement in grain moving machinery, and electrocution.
Researchers with the Agricultural Safety and Health Program of Purdue
University publish a report yearly, showing trends in the number of
grain entrapments and associated fatalities. Because small farming
operations are exempt from OSHA enforcement activities, OSHA cannot
investigate such incidents and determine the root causes to prevent
recurrence of such incidents. If Congress modifies the rider, OSHA can
inspect and thoroughly investigate the fatalities, and provide
necessary abatement methods and hazard recognition training to
employers engaged in small farming operations.
We assume that the provision of the direct compliance assistance
would be limited to the employers involved in the fatalities
investigated, and focused on decreasing the likelihood of a similar
injury or fatality at that facility. In this case, the agency would
continue the outreach it already engages in (noted above) but could not
meaningfully expand proactive outreach and compliance assistance to
smaller farm operations. In many instances, when OSHA responds to a
fatality in an agricultural operation and determines that it has no
enforcement jurisdiction (e.g., where an incident is voluntarily
reported), the responding staff will nevertheless advise them that
there is important safety and health information on the OSHA website
that could help them to decrease the likelihood of a similar injury or
fatality. However, the agency could enhance this effort by using the
findings gathered through any resulting investigations to augment
existing compliance assistance materials and share them broadly through
its outreach efforts. The agency may also be able to engage with the
individual employers through the On-site Consultation program; this
would need to be evaluated at the time the rider is issued.
multilingual worker protection staff
Question. The missions of worker protection agencies of the
Department of Labor include coverage of and assistance to all workers,
including those who speak languages other than English.
Please provide current counts of the number of multilingual staff
for the Wage and Hour Division (WHD) and Occupational Safety and Health
Administration (OSHA) in total and by region.
Answer. OSHA has a total of 111 staff who are multilingual. The
breakout by region is shown in the table below.
------------------------------------------------------------------------
OSHA Multilingual Staff 2021
-------------------------------------------------------------------------
Region Staff
------------------------------------------------------------------------
1 4
------------------------------------------------------------------------
2 4
------------------------------------------------------------------------
3 8
------------------------------------------------------------------------
4 14
------------------------------------------------------------------------
5 38
------------------------------------------------------------------------
6 14
------------------------------------------------------------------------
7 16
------------------------------------------------------------------------
8 0
------------------------------------------------------------------------
9 7
------------------------------------------------------------------------
10 4
------------------------------------------------------------------------
National Office 2
------------------------------------------------------------------------
Total 111
------------------------------------------------------------------------
These data were provided by the Office of the Assistant Secretary
for Administration and Management and includes positions that may
require a foreign language capability.
In total, WHD has 573 employees who are multilingual and speak 21
different languages.
By Region, the Northeast Region has 136 multilingual staff, the
Midwest Region has 87 multilingual staff, the Southeast Region has 107
multilingual staff, the Southwest Region has 117 multilingual staff,
and the Western Region has 126 multilingual staff.
Question. How will the Department use resources in the current
fiscal year and requested for fiscal year 2022 to recruit and hire
multilingual, qualified candidates for roles as investigators,
inspectors and other critical positions where language barriers could
prevent an agency from fulfilling its statutory mission? How will the
Department assess such language gaps and plan to meet its language
needs in carrying out the missions of its agencies?
Answer. OSHA plans to recruit and hire multilingual qualified
candidates for investigators, inspectors and other positions by working
with organizations such as Historically Black Colleges and
Universities, Hispanic Serving Institutions, the Asian American Network
and other organizations so that the agency's workforce has the
multilingual capabilities that reflects the communities that OSHA
serves. By reaching the most hazardous worksites and facilities, the
agency not only helps secure safe and healthy workplaces and reduce
workplace injuries, illnesses, and deaths, but also protects at-risk
workers in marginalized communities, who are less likely to have the
protections and training to work safely in high-hazard workplaces.
The Wage and Hour Division (WHD) utilizes targeted recruitment
strategies to attract a diverse pool of highly qualified candidates for
WHD positions. WHD routinely includes language requirements when hiring
to ensure that investigators can successfully communicate with workers
and employers about their rights and responsibilities under the law.
Currently, WHD has more than 570 multilingual staff.
In fiscal year 2022 WHD will continue to assess hiring needs
through a data-driven approach that will help to identify gaps in
services and resource allocation to particular communities. WHD is
implementing plans to increase recruitment and outreach to Minority
Serving Institutions and community based organizations to continue to
reach diverse applicants and ensure a pipeline of investigators who
reflect the communities they serve. Finally, WHD is opening positions
in remote, low-wage, underserved communities nationwide and increasing
flexibility in telework to serve these areas.
Question. Please describe how the WHD and OSHA will work with
stakeholders, including community-based organizations in reaching
worker populations such as those with language access barriers and
other factors that may contribute to a decreased likelihood of filing
of a complaint for a violation of labor law protections.
Answer. OSHA remains committed to working with and engaging its
whistleblower stakeholders. The agency has been conducting two
stakeholder meetings per year, some targeting specific industries,
seeking input and suggestions from them on a myriad of issues, such as
how to provide better customer service and how to conduct better
outreach to the public. The agency also listens to their concerns
regarding how the coronavirus pandemic has affected their workplaces.
The agency reviews each and every comment and suggestion from these
meetings and has implemented a number of them.
As a result of the most recent stakeholder meeting in May 2021,
OSHA is reaching out to migrant worker groups who provided comments, to
more fully understand their concerns, and to work with them on enhanced
ways to reach out to the people they represent. In addition, the
agency's whistleblower website, www.whistleblowers.gov, contains many
outreach documents that provide information to workers who may have
been retaliated against for engaging in protected activity. Much of the
information is available in English and Spanish.
The agency is committed to not only inform workers of their rights,
but also to remind employers of their responsibilities under these
laws. Moreover, OSHA is actively promoting its Recommended Practices
for Anti-Retaliation Programs guidance document, which focuses on
assisting employers in creating an effective anti-retaliation program
in their workplaces, where workers feel comfortable reporting concerns
without fear of retaliation, and without the need to file a
whistleblower complaint in the first place.
OSHA continues to prioritize outreach to vulnerable worker
populations. For example, OSHA translated its educational and outreach
materials into Spanish \1\ and more than 30 other languages.\2\ These
resources are printable from OSHA's website and print copies may be
shipped at no cost upon request. Several focus specifically on
workplace rights \3\ and OSHA created a video on filing a complaint
that is available in both English \4\ and Spanish,\5\ which is shared
along with its publications through the agency's outreach efforts.
---------------------------------------------------------------------------
\1\ https://www.dol.gov/newsroom/releases/odep/odep20200429-0.
\2\ https://www.osha.gov/publications/bylanguage.
\3\ https://www.osha.gov/publications/bytopic/workers'-rights-
outreach.
\4\ https://www.youtube.com/watch?app=desktop&v=k70Ln7gRWDE.
\5\ https://www.youtube.com/watch?app=desktop&v=zgv-Fuqx3K4.
---------------------------------------------------------------------------
OSHA's Labor Liaisons \6\ maintain communication with organized and
unorganized workers, Committees on Occupational Health and Safety,
worker centers and coalitions, helping them navigate OSHA's
organizational structure and complaint procedures, and assisting them
in developing and updating health and safety programs.
---------------------------------------------------------------------------
\6\ https://www.osha.gov/workers/liasons.
---------------------------------------------------------------------------
The agency maintains regular communication with worker advocacy
organizations such as the National Council for Occupational Safety and
Health (National COSH), to ensure that safety concerns workers have
about their jobs are heard and addressed. On June 23, 2021, Acting
Assistant Secretary Jim Frederick participated in a bilingual town hall
meeting where he responded directly to questions from farm, poultry
plant, nursing home and other workers. Topics included the urgent need
to protect workers from heat exposure and the COVID-19 Emergency
Temporary Standard for healthcare. The recording is available in
English here \7\ and in Spanish here.\8\
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\7\ https://drive.google.com/file/d/
1HFikHihuIMbB69LGgdNsRsVkWCINtOXG/view.
\8\ https://drive.google.com/file/d/1gbM7sdTTonaNEGaMP-
PVO3Itdpf3uoH4/view.
---------------------------------------------------------------------------
OSHA has numerous regional and area office alliances with
Consulates \9\ of Mexico and other Latin American countries through
which the agency shares information in English and Spanish about
workplace safety and health hazards and workers' rights, including use
of the OSHA complaint process. OSHA's Region 5 Regional Office also has
an Alliance with the Consulate of the Philippines in Chicago.
---------------------------------------------------------------------------
\9\ https://www.osha.gov/alliances/byemphasis#consulate-alliances.
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OSHA Compliance Assistance Specialists participate in regional task
forces and committees established to protect migrant farmworkers in
both the midwest and southeastern United States. Each August, OSHA and
WHD collaborate in supporting Labor Rights Week, a joint initiative
between the governments of the United States and Mexico to increase
awareness in the Mexican and Latino communities about the rights of
workers, including immigrant workers.
WHD is currently engaged in the Essential Workers, Essential
Protections initiative, which includes collaborating with stakeholders
nationwide to train them in protections for the most vulnerable, at-
risk worker populations as we emerge from the pandemic. Efforts to date
include conducting hundreds of educational webinars, reaching more than
26,000 participants; training advocates on how to file complaints;
producing and continuing to air television and radio public service
announcements in English and Spanish; and producing and placing
workers' rights posters in local stores to reach marginalized
populations. A nationwide series of listening sessions is now underway
to hear directly from stakeholders in contact with these workers how we
can better reach them. These efforts are designed to strengthen
relationships with community based organizations who are trusted
resources for the most vulnerable workers and can refer workers, file
third-party complaints, and amplify WHD's enforcement efforts.
subminimum wage
Question. The budget requests $42.7 million, an increase of $3.7
for the Office of Disability Employment Policy (ODEP). The budget notes
a priority for ODEP to advise Federal agencies and assist states and
employers in transitioning workers away from sub-minimum wage
employment currently authorized under 14(c) of the Fair Labor Standards
Act to competitive, integrated employment. My home state of Washington
recently enacted legislation ending a similar authority for issuing
certificates to pay workers with a disability less than the state
minimum wage generally as of July 31, 2023.
Please identify the Federal agencies involved and describe the
planned advisements that ODEP has for this and next year.
Answer. ODEP works with multiple Federal agencies to advance
competitive integrated employment (CIE) in order to reduce reliance on
Section 14(c) certificates. CIE is employment that pays at least the
Federal minimum wage (or state minimum wage when higher) and allows an
employee with a disability to interact with people without disabilities
to the same extent able-bodied employees interact with one another. The
main Federal agencies ODEP collaborates with include:
--AbilityOne
--Department of Labor (DOL), Office of Federal Contract Compliance
Programs (OFCCP)
--DOL, Employment and Training Administration (ETA)
--DOL, Employee Benefits Security Administration (EBSA)
--DOL, Veterans' Employment and Training Services (VETS)
--DOL, Wage and Hour Division (WHD)
--Department of Education (ED), National Institute on Disability
Independent Living, and Rehabilitation Research (NIDILRR)
--ED, Office of Career Technical and Adult Education (OCTAE)
--ED, Office of Special Education and Rehabilitation Services (OSERS)
--ED, Office of Special Education Programs (OSEP)
--ED, Rehabilitation Services Administration (RSA)
--Department of Health and Human Services (HHS), Administration for
Community Living (ACL)
--HHS, Centers for Medicare and Medicaid Services (CMS)
--HHS, Substance Abuse and Mental Health Services Administration
(SAMHSA)
--Social Security Administration (SSA)
--Department of Veterans Affairs (VA), Veterans Health Administration
(VHA)
--VA, Veterans Readiness and Employment (VRE)
ODEP planned activities and advisements for this year and next year
to promote CIE: In fiscal year 2021, ODEP is investing significant
effort \10\ to advance national and state-level policy promoting CIE to
reduce reliance on Section 14(c) certificates. ODEP maintains a list of
state ``Employment First'' policies and initiatives aimed at phasing-
out Section 14(c). The list is readily available to share with Federal
agencies, state partners and other stakeholders on request. ODEP
maintains a learning library of webinars and resources focused
specifically on advancing CIE and has worked directly in over 27 states
to align state policy, funding and service strategies to incentivize
integrated over segregated employment. ODEP remains a resource for
Federal agencies and state/local systems on use of best practices for
achieving CIE, such as supported and customized employment, and
reasonable accommodations. In designing activities to advance CIE and
eliminate Section 14(c) employment, ODEP organized the recommendations
of the Advisory Committee on Increasing Competitive, Integrated
Employment for Individuals with Disabilities (ACICIEID) into 10
critical areas. These 10 areas are needed for employment service
providers and systems to transform their systems from segregated to
competitive integrated business models and provide the overarching
framework for ODEP's work. Based on this framework, ODEP created a
Transformation Guide for states to assist in organizing the multiple
aspects of transformation needed across policy, funding and practice to
achieve CIE.\11\ Specific ODEP activities and advisements for fiscal
year 2021-2022 include:
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\10\ https://www.dol.gov/agencies/odep/program-areas/integrated-
employment.
\11\ http://drivedisabilityemployment.org/employment-first-
resources/e1st-state-transformation-guide.
---------------------------------------------------------------------------
--National Expansion for Employment Opportunities Network (NEON):
ODEP's NEON project assists provider agencies to increase CIE
outcomes and thus reduce reliance on Section 14(c) employment.
In fiscal year 2020, NEON selected and worked with five
national provider organizations (NPOs): ACCESS, the American
Network of Community Options and Resources (ANCOR), the
Association of People Supporting Employment First (APSE), the
Arc US and SourceAmerica. ODEP helped the NPOs create national
strategic plans for their employment provider networks to
transition away from Section 14(c) strategies and increase CIE
outcomes. Through NEON, ODEP also supported 19 local provider
organizations (LPOs) transition to CIE in fiscal year 2020. In
fiscal year 2021, NEON is assisting 48 providers in 19 states,
including Washington state. ODEP is also working through NEON
to create a National Plan to Increase CIE within the provider
community (anticipated for release in late 2021). In addition,
ODEP manages a monthly Community of Practice bringing national
experts, promising practices and real-life examples of provider
transformation to the over 2,700 participants from every state.
In fiscal year 2022, NEON will support up to 75 LPOs with
transition to CIE, and will provide support and technical
assistance to implement the NEON National Plan to Increase
CIE.\12\
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\12\ https://www.dol.gov/newsroom/releases/odep/odep20200429-0.
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--Advancing State Policy Integration for Recovery and Employment
(ASPIRE): Established in fiscal year 2021, ODEP's ASPIRE
initiative provides technical assistance to seven states to
help them develop and align policies, funding and service
strategies to increase CIE for people with mental health
conditions. Each state is required to involve key systems that
provide employment service and support including: Vocational
Rehabilitation, Mental/Behavioral Health, Medicaid and
Workforce Development. ASPIRE's goal is to coordinate policy,
funding and service strategies to increase availability of
evidence-based supported employment opportunities for people
with mental health conditions in the state. A technical working
group (TWG) composed of national mental health stakeholder
organizations, mental health national experts and intermediary
associations of state and local government agencies provide
ongoing information and assistance to ASPIRE states. In
addition, a supported employment learning community meets
monthly to bring cutting-edge information on key issues in
supported employment implementation to ASPIRE states. In fiscal
year 2022, ODEP will expand the number of states included in
ASPIRE, and will utilize its State Exchange on Employment and
Disability (SEED) to increase state policy alignment across
systems to increase CIE for people with mental health
conditions.\13\
---------------------------------------------------------------------------
\13\ https://www.dol.gov/agencies/odep/initiatives/aspire.
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--ODEP's work with VA and DOL VETS on CIE for Veterans with
Disabilities: In fiscal year 2021, ODEP partnered with the VA's
VRE and VHA and DOL's VETS to develop and release two videos to
raise awareness about customized employment as an effective
strategy to help veterans with disabilities move from sheltered
employment or unemployment into CIE. Released in February 2021,
the videos are available at: Customized Employment Works for
Veterans: A Job That I Love \14\ and Customized Employment
Works for Veterans: A Win-Win Strategy.\15\
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\14\ https://www.youtube.com/watch?app=desktop&v=xIsekJpeyiw.
\15\ https://www.youtube.com/watch?app=desktop&v=5CFjKwJtXqc.
---------------------------------------------------------------------------
--ODEP work on Rate Rebalancing to Incentivize CIE: In May 2021, ODEP
released a comprehensive policy guide on state rate
reimbursement restructuring titled ``Value-Based Payment
Methodologies to Advance Competitive Integrated Employment: A
Mix of Inspiring Examples from Across the Country''. Guidance
on rate reimbursement restructuring is critical to increasing
CIE for people with significant disabilities. Many existing
rate structures are based on the assumption that some people
with disabilities are incapable of work, rather than on an
Employment First framework that assumes all people are capable
of work if given the necessary supports, accommodations and
work environment. ODEP developed three webinars on rate
restructuring in which relevant state agencies (Medicaid,
Vocational Rehabilitation, Mental/Behavioral Health) and
providers discuss how adjusting service rates enabled them to
incentivize CIE over segregated work models. This is important
because some state systems may reimburse providers higher
amounts for segregated outcomes. These systems could instead
elect to include services necessary for CIE in their list of
covered services and incentivize their use through higher
reimbursement rates. The webinars providing examples from
multiple states and multiple different systems include: (1)
Value, Outcome and Performance-Based Payment Methodologies to
Advance Competitive Integrated Employment in State Medicaid
Long-Term Services and Supports (LTSS) Systems and Managed Care
LTSS Systems; (2) Supporting Employment Service Providers to
Succeed and Prosper by Partnering to Advance Competitive
Integrated Employment: Applying Value, Outcome and Performance-
Based Payment Methodologies; and (3) Advancing Competitive
Integrated Employment: Value, Outcome and Performance-Based
Payment Methodologies in State Vocational Rehabilitation and
Behavioral Health Systems.
--Financial Literacy and Benefits Planning through the Lifespan:
Financial Literacy Toolkit: ODEP also worked with DOL's EBSA to
develop a toolkit for youth and adults with disabilities to
assist with their finances as they consider employment,
retention and advancement. It also shows them how they can
build savings. This toolkit provides valuable information for
all phases of employment, including consideration of the impact
on benefits from working as people with disabilities move from
sheltered settings to CIE. It provides information in essential
areas such as work incentives, Achieving a Better Life
Experience (ABLE) accounts, and other areas of financial
literacy essential for people with disabilities. For example,
one important resource is the new fact sheet on the Medicaid
buy-in, developed by ODEP in collaboration with ACL and CMS
(see Medicaid Buy-In Q&A Medicaid ``Buy-In'' Q&A
(dol.gov)).\16\ ODEP will continue to develop new resources in
this area and add them quarterly. On July 27, ODEP and EBSA
hosted a webinar, Secure Your Financial Future: A Toolkit for
Individuals with Disabilities,\17\ to launch this new financial
literacy toolkit.\18\ I provided welcoming remarks for the
webinar.
---------------------------------------------------------------------------
\16\ https://www.dol.gov/sites/dolgov/files/odep/topics/
medicaidbuyinqaf.pdf.
\17\ http://leadcenter.org/webinars.
\18\ https://www.dol.gov/agencies/ebsa/secure-your-financial-
future.
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--Workforce Innovation and Opportunity Act (WIOA) Workforce
Development System: ODEP efforts to expand access to CIE
includes leveraging the services and connections available
through the American Job Centers (AJC) system operated under
WIOA. AJCs can register to become Employment Networks (ENs)
under the Ticket to Work (TTW) program. ENs are reimbursed for
employment services on a milestone basis for successfully
assisting people with disabilities into CIE employment.
Consequently, ODEP worked to expand the impact of the TTW/EN
program by connecting providers of CIE employment services to
ENs. The goal was to leverage additional support in achieving
CIE for people with disabilities who are eligible Social
Security recipients under TTW. To assist in this effort, on May
2021, DOL released a Ticket to Work: Operating a Workforce EN
Planning Guide and Workbook to promote the benefits of
operating as a workforce EN and to enhance awareness of
available resources to help in this process, including guidance
and promising practices. ODEP, ETA and SSA developed this
technical guide with input from 19 workforce systems currently
operating as ENs. The planning guide and workbook assist state
and local area workforce leadership in the process of becoming
and operating as a workforce EN. It includes a set of
activities (e.g., checklists, discussion questions and
exercises) to help walk through the process to make an informed
decision, and serve as an operational resource for existing
workforce ENs. ODEP also held a webinar on May 26, 2021,
Practices in Workforce Employment Network Operation--New
Technical Guidance,\19\ which provided highlights from the
technical guide, promoted the advantages this opportunity
provides to local workforce systems and shared the experiences
of three current workforce systems from the workforce EN
operators.
---------------------------------------------------------------------------
\19\ https://www.workforcegps.org/events/2021/03/23/13/16/
Practices-in-Workforce-Employment-Network-Operation-New-Technical-
Guidance.
---------------------------------------------------------------------------
--Advisement to Federal State and Local Governments, Providers and
Individuals with Disabilities on Current Federal Investments to
Advance CIE: In July 2021, in recognition of the 31st
anniversary of the Americans with Disabilities Act, ODEP
released a new fact sheet, ``Recent Funding Opportunities to
Expand Access to Competitive Integrated Employment (CIE) for
Individuals with Disabilities'', developed in collaboration
with the HHS' CMS, ACL, SAMHSA; ED's RSA and OSEP; and SSA. The
fact sheet highlights new funding and flexibilities which
provide significant opportunities to increase access to CIE for
youth and adults with disabilities. The increased funding and
flexibilities are provided under the Coronavirus Aid, Relief
and Economic Security Act (CARES), the American Rescue Plan Act
of 2021 (ARP), the Coronavirus Response and Relief Supplemental
Appropriations Act (CRRSA), the Further Consolidated
Appropriations Act of 2020 (FCAA), and through the work of
multiple Federal agencies providing services to individuals
with disabilities. The CIE fact sheet is located on the ODEP
web page at: Recent Funding Opportunities to Expand Access to
Competitive Integrated Employment (CIE) for Individuals with
Disabilities.\20\
---------------------------------------------------------------------------
\20\ https://www.dol.gov/sites/dolgov/files/ODEP/pdf/
508_odep_cie_07152021.pdf.
---------------------------------------------------------------------------
--Disability Innovation Fund: ED's RSA and ODEP are discussing RSA's
2020 and 2021 Disability Innovation Fund, which currently has
approximately $110 million in fiscal year 2020 available
funding, resulting from unused Federal vocational
rehabilitation funding returned by states. Congress directed
RSA to consult with DOL regarding the use of fiscal year 2021
funds. For the fiscal year 2021 funds, Congress stipulated that
the funds be used to award competitive grants to improve
opportunities for CIE for individuals with disabilities. ODEP
is working with WHD, RSA, ACL and CMS to design the next set of
grants.
Question. How does ODEP plan to assist states and employers in such
transitions?
Answer. ODEP remains committed to helping states and employers
transition from segregated Section 14(c) employment to CIE outcomes.
ODEP's most critical activities include NEON, ASPIRE, and a new
collaboration between ODEP's SEED initiative with ASPIRE and NEON.
--National Expansion for Employment Opportunities Network (NEON): As
described above, ODEP's NEON project assists provider agencies
to increase CIE outcomes and thus reduce reliance on Section
14(c) employment. In fiscal year 2022, NEON will increase the
number of providers developing and implementing transformation
plans and assist states in the critical task of rebalancing/
aligning their service funding in support of CIE. ODEP is also
developing multiple NEON tools for release. These include, but
are not limited to: an Employment First statewide strategic
planning manual to assist states in organizing their statewide
strategic planning efforts to effectively engage stakeholders
and implement Employment First systems change and a state self-
assessment tool for increasing CIE to assist states in
evaluating current policies, practices and infrastructures in
each of the Ten Critical Areas to Increase Competitive
Integrated Employment. The 10 sections of the assessment tool
are based on the recommendations of the final report of the
Advisory Committee on Increasing Competitive Integrated
Employment for Individuals with Disabilities. Additional focus
in NEON fiscal year 2022 activities will assist providers in
implementing the NEON National Plan to Increase CIE (expected
release late 2021).
--Advancing State Policy Integration for Recovery and Employment
(ASPIRE): As described above, ODEP's ASPIRE initiative is
assisting states and providers with aligning policy, funding
and service strategies across systems This is needed to expand
access to evidence-based supported employment throughout
participating states. In fiscal year 2022, ODEP will expand the
number of states included in ASPIRE, and will collaborate with
ODEP's SEED initiative to increase state policy alignment
across systems in other states to increase CIE for people with
mental health conditions.
--State Exchange on Employment and Disability/ASPIRE/NEON
partnership: ODEP's SEED works through state intermediary
organizations such as the National Conference of State
Legislatures (NCSL), the National Governors Association (NGA),
and the Council of State Governments (CSG) to assist state
legislatures and governors in developing more inclusive
workforce policies that promote disability employment. Since
transitioning away from subminimum wage is a priority for DOL
and an increasing priority for states, SEED and its
intermediaries will actively promote legislative and
administrative policy options for consideration by all of the
states, as well as share examples of recently passed or enacted
legislation. In fiscal year 2022, SEED and its intermediaries,
including NGA, will work with ODEP's ASPIRE and NEON
initiatives to establish a policy collaborative that will focus
on assisting those states supporting CIE and the phase-out of
Section 14(c). States with more mature CIE policy in place will
participate as CIE leaders to assist states with less developed
CIE policy, and subject matter experts will work directly with
participating states to develop CIE transformation plans.\21\
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\21\ https://www.dol.gov/agencies/odep/state-policy.
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bls move
Question. The last two Department of Labor Appropriations Acts have
appropriated a total of $40 million requested for the move of the
headquarters of the Bureau of Labor Statistics (BLS). The Congressional
Budget Justifications for fiscal years 2020 and 2021 both identified
this amount as the share of total project costs that BLS would
contribute to the move, with the General Services Administration (GSA)
paying for the remainder of construction and real property costs of
nearly $50 million. The fiscal year 2022 BLS budget requests $28.5
million for a portion of these real property costs and indicates the
remaining costs would be initially financed by the GSA and repaid by
BLS over time after the move is complete.
Why has GSA backed out of paying its share of project costs?
Answer. The fiscal year 2020 Budget, released in March 2019,
announced that the BLS headquarters would move to the Suitland Federal
Center. At the time, based on a high-level assessment of the project,
the Budget estimated a total project cost of $89 million. The personal
property costs of $40 million were assigned to BLS, and GSA was
assigned the real property costs at $49 million. These estimates were
done in advance of a detailed building assessment study which expanded
the scope of the renovation project resulting in a new cost estimate
and a detailed assignment of costs between BLS and GSA. The fiscal year
2022 BLS budget request for $28.5 million reflects this revised cost
estimate and an updated determination that BLS would fund tenant
improvement costs, the costs to be borne by the agency consistent with
the publicly posted GSA pricing guide, through a combination of
appropriated dollars (paid up front) and a tenant improvement allowance
(repaid over time through the rent stream). GSA's fiscal year 2022
budget also reflects increased renovation costs with a request of $20
million in fiscal year 2022. GSA continues to fund all renovation costs
consistent with the pricing guide while BLS is funding the tenant
related costs consistent with projects in GSA owned facilities.
Question. What actions has DOL taken to secure the GSA contribution
that DOL stated in prior Congressional Budget Justifications GSA would
provide?
Answer. Throughout the project, DOL has worked closely with GSA to
refine cost estimates and clarify funding mechanisms. This has involved
numerous and regular meetings with GSA executives within the National
Capital Region, in consultation with the Office of Management and
Budget.
Question. Please describe how the $28.5 million requested for costs
that GSA was going to cover could instead be used to strengthen BLS
programs for measuring labor market activity, working conditions,
productivity and other critical information for understanding the
economy of the United States? What about the additional $23.8 million
in costs that would need to be repaid in the future?
Answer. As mentioned above, the fiscal year 2022 BLS budget request
for $28.5 million reflects the revised cost estimate to realize the
move with the associated reduced footprint and the long-term rent
savings for the BLS National Office. The Department strongly supports
the move, as it will produce considerable savings and efficiencies that
will contribute to BLS' achievement of its mission. If the BLS
appropriation for fiscal year 2022 instead directed the $28.5 million
in additional funding for base programs, the BLS could fund work on
additional statistical program improvements that have been of interest
to Congress, such as improving the Job Openings and Labor Turnover
Survey (JOLTS) and Consumer Expenditure (CE) program poverty
measurement. However, without this funding, the BLS Suitland move would
be interrupted and the project timeline would be prolonged.
Additionally, it is critical for work to proceed in a timely fashion as
the $40 million appropriated to date for the move expires September
2024. Once the BLS National Office is located at Suitland, rental
savings are expected, which could be used to cover the tenant
improvement costs to be repaid over time and future program
improvements.
The $23.8 million in estimated costs to be paid to GSA in the
future are intended to take place over the course of several years in
the form of a tenant improvement allowance. As such, the payments will
be part of the BLS rent bill at the Suitland Federal Center (SFC) and,
at that level, will reduce the expected rent savings at the SFC by
approximately $2.5 million per year.
whd and osha foia requests
Question. With over 1,700 Freedom of Information Act requests
backlogged at the Wage and Hour Division and more than 800 backlogged
at the Occupational Safety and Health Administration as of the second
quarter of fiscal year 2021, it's clear more needs to be done to timely
process these requests.
Please identify the funding and staffing level dedicated to this
work at each of these agencies in the current fiscal year and the
amounts and staffing level in the fiscal year 2022 request.
Answer. OSHA's FOIA program is decentralized, with designated staff
performing FOIA work largely as an additional duty in the national
office and field offices across the country, and does not have a
designated budget line item. The funding and staffing for OSHA's FOIA
work is calculated based on a survey on the number of staff involved
and amount of time spent working on the program. In fiscal year 2020,
eight FTE worked full-time on FOIA. Staff working on FOIA as an
additional duty accounted for the equivalent of 54 FTE, for a total of
62 FTE working on the FOIA program at a cost of $6.4 million.
In fiscal year 2021, the Wage and Hour Division had nine FTE at an
approximate cost of $1.1 million performing work related to the Freedom
of Information Act. In fiscal year 2022, the Wage and Hour Division
expects staffing levels to be 11 FTE for approximately $1.3 million to
perform this work.
Question. What steps are these agencies taking and planning to
timely process FOIA requests?
Answer. OSHA acknowledges that there is room for improvement in the
FOIA program and is working to address the backlog of requests and to
improve the timeliness of responses to new requests. OSHA processes
approximately 9,000 FOIA requests every fiscal year. This accounts for
approximately 60 percent of all FOIA requests that come into the
Department of Labor. OSHA's FOIA program is decentralized and consists
mainly of staff working on FOIA requests as an additional duty. OSHA's
Office of Communications (OOC) coordinates the agency's FOIA program
and routinely coordinates with staff working on FOIA throughout the
country to address any issues, share information, and provide necessary
training. OOC continuously looks for ways to improve the effectiveness
and efficiency of the FOIA program. For example, OOC has conducted two
pilots to evaluate potential changes to the program's structure in
order to streamline and improve overall efficiency, consistency and
quality of the agency's FOIA process. The agency is evaluating the
results of the pilots and is considering next steps.
During fiscal year 2021, the Wage and Hour Division has reduced its
FOIA back log from 530 outstanding requests at the end of fiscal year
2020 to 285 as of July 30, 2021. WHD has accomplished this by
recruiting and retaining FOIA leadership and staff as well as
leveraging technological tools to speed processing requested records
within WHD.
ebsa consolidated budget
Question. The budget request for the Employee Benefit
Administration (EBSA) requests a consolidated employee benefits
security programs budget activity in place of separate budget
activities for enforcement and participant assistance, policy and
compliance assistance, and administration.
How would this new structure better enable EBSA to achieve its
statutory mission?
Answer. EBSA seeks to aggregate and consolidate program budget
activities for enforcement and participant assistance, policy and
compliance assistance, and program oversight.
By restructuring these three budget activities into a single
activity for Employee Benefits Security Programs, EBSA can simplify
agency performance reporting and streamline agency performance and
operating plan development and implementation.
Question. How would EBSA continue to provide transparency and
oversight of its spending for each of the eliminated budget activities?
Answer. EBSA believes that restructuring its budget activities will
facilitate the allocation and redistribution of resources from lesser
performing and lower priority strategies/programs to better performing
and higher priority strategies/programs. The restructured budget
activities will create a responsive organization that facilitates
results-based management. Additionally, the restructured budget
eliminates artificial lines between activities, all of which are aimed
at a single outcome--employee benefits security. While this
restructuring would promote the more efficient allocation of resources,
it would not have any negative impact on EBSA's ability and
responsibility to report responsibly to Congress on how it expends
appropriated funds or on the agency's resulting performance.
research and evaluation funding
Question. The budget proposes new evaluation funding flexibility
for the Chief Evaluation Officer and Bureau of Labor Statistics at the
Department of Labor, as well as for certain offices within the
Department of Health and Human Services.
Please describe how each of the new authorities requested would
better advance research, evaluation and statistical purposes at the
Department of Labor.
Answer. High-quality evaluations, research, and statistical surveys
are essential to building evidence about what works, why, and for whom.
They are also inherently complicated, dynamic activities, with
uncertainty about the timing and amount of work required to design,
implement, and complete the studies. Further, we often want to know
about the outcomes for workers both in the short- and longer-term. This
usually requires information collections spanning five or more years
beyond the particular intervention or program under study. The proposal
allows flexibility to strategically plan evaluations over time by
extending the obligation period to 5 years, rather than constraining
obligation within 1-2 years (as current authorities for BLS or the
Chief Evaluation Office allow). In addition, the currently available
procurement vehicles lack the flexibility needed to match the dynamic
nature of these evidence-building projects. Some studies provide high
quality information useful across DOL sub-agencies or across Federal
agencies; the proposed authority to use a single Treasury account for
such activities, when multiple originating appropriations are used,
enables efficiencies for awarding contracts to evaluate DOL programs
when portions of funding from several DOL accounts are needed to
sufficiently fund the project, or when cosponsoring research across
Federal agencies. The proposed flexibilities enable DOL to maximize the
use of evaluation resources, reduce burden to the public, and mitigate
duplication of Federal efforts.
Further, evaluation and research projects often encounter
unexpected circumstances due to their dynamic nature. The proposed
authority would permit unexpended funds to be repurposed for another
research, evaluation, or statistical project, which is often not
currently possible because of the time-limited and inflexible nature of
these funds. This would allow the funds to be used efficiently for
their original intent. In order to streamline these procurement
processes, improve efficiency, and make better use of existing
evaluation resources the Budget proposes to provide the Department of
Labor with expanded flexibilities to spend funds over a longer period
of time through the ``Evaluation Funding Flexibility'' outlined in
General Provision, Section 521. This request is part of a provision
which includes the Departmental Program Evaluation activity in the
Departmental Management appropriation and the Bureau of Labor
Statistics; as well as the Department of Health and Human Services'
Assistant Secretary for Planning and Evaluation and the Office for
Planning, Research and Evaluation in the Administration for Children
and Families. These flexibilities will allow agencies to meet the
collective aim of efficient government investment in evidence-building
with embedded adaptability to reflect changing circumstances on the
ground.
wcf unobligated balances
Question.The budget proposes to increase the transfer authority
from unobligated balances available to the Secretary in fiscal year
2022 to the Working Capital Fund (WCF) from $18,000,000 to $36,000,000.
The budget also proposes to create a multi-year funding authority for
building space optimization within the WCF.
Please identify the additional investments that could be supported
by the increased transfer authority and describe the cost avoidance and
risk reduction expected to be achieved through these additional
projects.
Answer. The Department will use these funds to modernize a host of
legacy agency applications. DOL's 27 agencies have developed and
maintained distinct, customized systems and applications to meet the
unique requirements of their respective missions, but many of these
systems and applications are outdated and quite cumbersome by modern
standards. These legacy applications are costly to maintain,
inefficient for both Federal staff and the public to use, and are less
secure than modernized alternatives.
The Department is well prepared to modernize these systems thanks
to investments in the centralized IT platform made through the IT
Modernization appropriation. By investing in and promoting DOL's
centralized IT platform, the Department has established common
foundational components that are being leveraged across the Department
to ensure scalability, reliability, innovative development and minimum
time to deployment. DOL's platform and standardized process to
consolidate disparate and outdated systems, enables data sharing and
component re-use--allowing DOL to be forward-focused and on the
forefront of innovation with capabilities such as data analytics, case
management, artificial intelligence and machine learning, and Robotic
Process Automation. In addition to access to this standardized process
and best practices, agencies have access to optimized infrastructure in
a hyper-converged, hybrid-cloud data center environment and
technologies that facilitate design of an overall improved user
experience to allow employees to focus on mission work instead of
technology. The cloud-based platform has helped achieve DOL-wide
operational efficiencies in support of mission-driven IT applications
resulting in consolidated resources, eliminated redundancies,
accelerated modernization, and enhanced security.
While DOL has made significant progress in investing in the IT
platform, there is still an extensive list of legacy systems requiring
modernization overhauls. By applying a set of common criteria, DOL
prioritized legacy systems for modernization. DOL has been working to
address the top 50 systems and is making progress in this multi-year
effort. Based on DOL's FITARA's score, DOL has a proven track record of
making the right investment decisions to streamline technologies and
garner efficiencies for its IT, but budget limitations impede progress.
Consolidating, integrating, and updating DOL's legacy systems improves
DOL's security posture with capabilities such as standardized PIV-based
application access, multi-factor authentication, Continuous Diagnostics
& Mitigation (CDM) for cyber incident detection and response, and real-
time vulnerability and threat monitoring. Investing in information
technology provides significant public-impacting benefits in many
policy areas, including mine safety, visa processing, grants
management, and retirement benefits assurance, among many others. This
authority will enable DOL to modernize systems to ease public access to
DOL services, improve accessibility for users with disabilities,
mitigate security issues due to legacy technologies, and reduce the
increasing costs of supporting incompatible and obsolete technologies.
Each effort will improve reliability and accessibility for the public
to the Department's programs for employment, worker safety and health,
and benefits.
The investments that can benefit by the increased budget authority
include (but are not limited to):
--OLMS--Electronic Labor Organization Reporting System (e.LORS)
Investment: OCIO has identified e.LORS as one of the highest
priority systems in the Department for modernization due to
inherent risks associated with this outdated legacy technology
which has no vendor support nor is it supportable by DOL's
cloud-based enterprise platform infrastructure. Modernization
is projected to provide initial annual cost savings of
approximately $600,000 the year following initial deployment.
After the system is fully deployed, OLMS expects to experience
a 15 percent savings in annual IT cost due to a reduction in
costs for maintenance of the new system versus the old.
--OSHA--Information Management System Investment: The data
modernization and Transparency Initiative will help with the
Agency's ability to store data, retrieve it in the most
applicable form for operational use, and provide it in the most
user-friendly format for the public. Internally, easier
accessibility, paired with standardized data output from the
OSHA systems, will result in more efficient searches and better
ability for staff to analyze the data to lead to swifter
decisionmaking. Improvements in data retrieval and analysis
could also provide OSHA staff with insight into the types of
violations they might find at a facility, or enable a
compliance assistance specialist to provide best practices to
abate hazards most likely to be found at the worksite. These
efficiencies will lead to improved performance and cost savings
will be realized in the higher utilization by OSHA data
stakeholders of standardized reports with reliable information.
--WHD--Wage Determination System Investment: Modernizing the agency's
technology infrastructure is critical to WHD's success and a
key factor in mitigating risk across the agency. With the
recent implementation of the Electronic Case File (ECF), WHD is
realizing the ways in which streamlined business processes and
more agile technology can revolutionize and bring value to the
agency's work. In doing so, WHD improves its abilities to be
good stewards of taxpayer money and to provide the best
possible service and results to those the agency is here to
serve. Cost savings will be achieved in the following areas:
(1) a shift to the cloud will minimize the need for WHD to pay
for expensive O&M resources, which will yield an estimated
savings of $3 million per year; (2) elimination of paper record
keeping costs associated with case files storage and
administration once ECF is fully rolled out, will yield an
estimated savings of $500,000 per year which equates to
1,557,000 pages transferred between offices and to record
centers per year; and (3) automated ingestion of data through
the new WDS customer portal will yield a reduced need for
contractor support on data entry and processing of paper
records and provide an estimated savings of $300,000 per year
in actual contract costs. This represents total costs impacts
of $4 million per year, which can be readily redirected towards
mission-critical enforcement staff and activities.
--OFCCP--Case Management System Investment: The Affirmative Action
Verification Initiative (AAVI) is modernization need that would
allow OFCCP to ingest and process its administrative data in a
more uniform digital format. It will also allow staff to
retrieve and store data in a central repository that will
improve operations and enforcement by driving efficiency and
increasing the number and depth of analytical assessments
performed by the scheduling, policy, and enforcement branches.
Once development is completed, the ongoing costs will be
operations & maintenance, and a fraction of the help desk
service. The total operating cost is anticipated to be reduced
by approximately 65 percent, assuming no further development
efforts.
Question. How will the Department assure that unobligated balances
for the WCF are only generated from unexpected balances rather than the
delay of spending on the original purpose of the Congressional
appropriation?
Answer. The Department has a robust program to ensure that
unobligated balances are only generated from unexpected balances. The
Office of the Chief Financial Officer meets regularly with agencies to
review budget execution data and, in coordination with the Performance
Management Center, tracks the percent of discretionary appropriations
canceled after the five-year period of obligation authority has
expired. The results are reported in the Congressional Budget
Justification. In fiscal year 2020, the Department targeted 1.9 percent
in canceled appropriations and outperformed this target with a
cancellation rate of only 1.6 percent.
learning agendas and evaluation plan
Question. The ``Foundations for Evidence-Based Policymaking Act of
2018'' includes key provisions related to developing a multi-year
learning agenda, evaluation plan, improving coordination of data
government at the Department, and improving accessibility of labor
data. The Department has indicated it plans to release an updated
learning agenda and Capacity Assessment for Research, Evaluation,
Statistics, and Analysis in February 2022.
Please describe stakeholder consultations that have occurred or
will occur during the development of these plans.
Answer. The Department has engaged with a wide range of
stakeholders external to DOL to understand evidence production, use,
and future needs. For example, given the critical role of the
Department in supporting the public workforce system across the
country, DOL targeted early engagement with the workforce development
field. From November 2020 to April 2021, the Department sponsored
unstructured group discussions and individual conversations with 104
individuals representing 53 organizations spanning the U.S. workforce
development system. The objectives of the meetings were to encourage
participants to discuss what research, information, or evidence would
be most useful to them to improve the services they provide, and to
identify future research topics related to employment programs and
services and the future of work.
In addition to this broad-based engagement, the Department convened
an 11-member panel of highly qualified experts in the workforce
development field, including representatives from workforce boards,
academics, nonprofit organizations that partner with or study the
workforce system, and labor unions. The panel provided DOL with
targeted input on high-priority research topics related to WIOA
programs and services that could build on the current evidence base,
fill key knowledge gaps, and could be potentially suitable for rigorous
evaluation. A summary of the findings from these engagements will be
available on the Department's Chief Evaluation Office website later
this year.
DOL has also sought input on our evidence-building agenda from
Congressional stakeholders. On July 29, 2021, DOL's Office of
Congressional and Intergovernmental Affairs sponsored a Congressional
outreach session, which included a high-level briefing on the
Department's strategic and evidence-building planning approach.
Further, it allowed Congressional aides from both appropriations and
authorizations committees to ask questions and to provide direct
comments and reactions on the Department's activities.
Looking to the future, the Department will gain insights from
additional activities. For example, the responses to the equity RFI
issued by OMB on May 5, 2021 will be helpful to all Federal agencies,
including the Department, in evidence-building plans.\22\ Further, the
Department will engage in further targeted stakeholder feedback, to
support ongoing evidence development and dissemination activity. As
evidence building evolves to meet emerging needs, the Department
anticipates refining activities based on future stakeholder inputs. DOL
is especially interested in ensuring perspectives from a diverse array
of stakeholders who represent the communities our programs serve.
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\22\ The full text on the OMB RFI, Methods and Leading Practices
for Advancing Equity and Support for Underserved Communities Through
Government, can be found here: https://www.govinfo.gov/content/pkg/FR-
2021-05-05/pdf/2021-09109.pdf.
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Question. What has the Department learned from its prior
evaluations and how has the information been used in decisionmaking and
its programs, policies and operations? How will it inform future
decisions on programs, policies and operations?
Answer. The Department has learned a great deal from its
evaluations, data analytics efforts, surveys, and other rigorous
research projects to help improve our work on specific programs and
topics, and also to better understand how to best help specific
populations, especially populations facing barriers to full
participation and inclusion in the labor market. Specifically, the
Department has used the results from its evaluations and rigorous
research to expand and scale proven training strategies, to better
target enforcement and worker protection activities, to identify
underrepresented populations for tailored outreach, and even to improve
internal employee engagement, among other outcomes.
As decision-makers develop policies and programs to support workers
with job training and other employment supports, they have used the
results of evaluations to effectively target future investments. One
important example comes from evaluations of the Registered
Apprenticeships (RA) program. DOL funded a large-scale impact study of
RAs across 10 states, which was published in 2012. That study found
that RA participants had substantially higher short- and long-run
earnings than did non-participants and that the broader benefits of the
RA program for apprentices, government agencies, and society greatly
outweighed program costs. RA participants earned an average of $5,839
more than similar nonparticipants. Further, the completers of RA
programs earn over $300,000 more in salary and benefits during their
careers than similarly situated individuals who do not complete such
programs. This study is regularly cited by researchers, program
administrators, and policymakers as evidence for the return on
investment to RAs.
In part on the basis of those findings, both Congress and the
Department have pursued expansions of the RA program. In partnership
with the Department's Employment and Training Administration, the Chief
Evaluation Office is now actively evaluating these new investments in
the RA program, including studying efforts to expand apprenticeships to
underrepresented populations, as well as assessing the effectiveness of
expanding apprenticeships into high-growth and high-paying industries,
such as information technology.
Another important area of ongoing evidence-to-practice is related
to building the capacity of the nation's community colleges' education-
to-employment pipeline to meet 21st century demands. Based on the
results of a national evaluation of the DOL capacity-building grant
program, Trade Adjustment Assistance Community College and Career
Training (TAACCCT), the Department identified a range of promising
practices for future adoption including accelerated learning/career
pathways, persistence and completion strategies, and learning-based
connections to employment. The national evaluation generated these and
a wealth of other findings based primarily on a synthesis of 71
evaluation reports completed by grantees' third-party evaluators.
Evidence-based practices and insights from these studies' findings are
being applied to the Strengthening Community Colleges Training Grants
(SCCTG) Round 2 Funding Opportunity Announcement and future DOL
investments.
The Department has also helped states and local areas in their
efforts to build strong evaluation capacity, such as with the
Reemployment Services and Eligibility Assessment (RESEA) program.
Beyond funding and broadly disseminating findings from the largest
evaluation of the RESEA predecessor program, Reemployment and
Eligibility Assessment (REA) program, the Department has developed a
suite of resources to support states in implementing and leveraging
insights from the evidence base, as they build, pilot, and evaluate new
RESEA program components. The Department has provided evaluation
technical assistance resources, including webinars and other tools and
templates to help states understand, build, and use evidence.\23\
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\23\ The Department has developed a number of dedicated web-based
resources for states, including https://clear.dol.gov/reemployment-
services-and-eligibility-assessments-resea and https://
rc.workforcegps.org/resources/2016/10/03/06/29/RESEA.
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Other research efforts with notable impact on Departmental
operations include the Family and Medical Leave Act (FMLA) surveys of
workers and businesses. Fielded in 1995, 2000, 2012, and 2018, these
large-scale nationally representative surveys represent a primary
source of credible information about workers' leave needs, patterns of
usage, reasons for leave, awareness of leave benefits, among many other
factors. In addition, the size of the survey sample permits
disaggregation and analysis by geography and a variety of demographic
groups. The results of these surveys have helped the Department improve
and target educational campaigns on Federal leave worker protections,
as well as to provide technical assistance to businesses with
administration of this benefit as part of compliance and enforcement
efforts. The surveys have also been very important to Federal, state,
and local policymakers interested in understanding gaps in worker leave
needs and designing potential leave program proposals.
Question. What are the Department's plans for increasing the
investment in evaluation and evidence-building activities authorized by
the annual evaluation transfer provided in the Department of Labor
Appropriations Acts which significantly decreased from more than
$22,000,000 in fiscal year 2016 to $2,000,000 in fiscal year 2020?
Answer. The Department is committed to supporting a robust research
and evaluation portfolio, including the capacity to develop and deploy
evidence across agency management activities. Doing so is consistent
with this Administration's priorities, as reflected in the President's
Memorandum on Restoring Trust in Government through Scientific
Integrity and Evidence-Based Policymaking and through the Office of
Management and Budget's guidance to Federal agencies on the
implementation of the Evidence Act (OMB M-21-27). Bolstering the
Department of Labor's research and evaluation activities is reflected
in our fiscal year 2022-2026 strategic plan, which includes a
management goal to ``strengthen the Department's commitment and
capacity for evidence-based decisionmaking.''
______
Questions Submitted by Senator Jack Reed
wioa and public libraries
Question. Workforce Innovation and Opportunity Act and Public
Libraries.--Public libraries are critical but often under-resourced
partners in the workforce development system supported under the
Workforce Innovation and Opportunity Act. As the nation continues to
recover from the COVID-19 emergency, libraries will play a critical
role in helping people access benefits and get back to work.
What are the Department's plans to build and strengthen
partnerships between the one-stop system and public libraries and
ensure that public libraries have the resources necessary to provide
these workforce development services?
Answer. States have used WIOA funding for partnerships with public
libraries to conduct digital and financial literacy education
activities; educate library staff about available in-person and virtual
employment and workforce development resources; provide resume writing,
interview preparation, and other adult education programs; use the
libraries' space to provide career assistance and host job fairs; and
share workforce and labor market information. As an example,
California's Library Workforce Partnership Initiative (LWPI) recently
announced a funding opportunity for ten California public libraries to
partner with local Workforce Development Boards to build staff skills
and knowledge about workforce development and enhance workforce
development efforts in their communities. Local Boards in California
will work with public libraries, and together they will promote
employment, career development, and skill-building for job seekers.
The Department has partnered with the Institute of Museum and
Library Services (IMLS) for several years and continues to collaborate
with libraries since the passage of the Workforce Innovation and
Opportunity Act. This collaboration has included webinars to ensure
both libraries and the workforce development system know about the
assets and services they each have available to support jobseekers. The
Department published guidance to the workforce system reiterating the
importance of library partnerships and continues to make the workforce
system aware of the resources available in libraries to support
workforce development (See Training and Employment Notice 35-15,
``Encouraging Collaborations between the Workforce Investment System
and Public Libraries to Meet Career and Employment Needs'').
Other ongoing collaborative work with IMLS includes the Performance
Partnership Pilot (P3) authorized in 2014, in which pilot sites can
test innovative strategies to achieve significant improvements in
education, employment, and other key outcomes for disconnected youth.
P3 gives the Departments of Education, Labor, Health and Human Services
(HHS), and Justice (DOJ), the Corporation for National and Community
Service (CNCS), and IMLS authority to waive Federal statutory and
regulatory requirements that inhibit access to assistance and effective
service delivery for disconnected youth provided certain conditions and
requirements are met.
Public libraries play an integral role and are a crucial resource
in communities for job seekers. The Department will continue working
with libraries and promoting libraries as key partners in the workforce
system.
______
Questions Submitted by Senator Joe Manchin, III
black lung benefits
Question. Black lung is a terrible disease caused by inhaling coal
dust and mainly affects coal miners. After years of dedication to
providing our nation with energy, America's coal miners continue to
face the devastation of black lung disease. We are seeing more and more
cases of black lung--particularly in younger miners who have spent less
time working in the mines. Today, more than 25,000 coal miners and
their dependents rely on the Black Lung Disability Trust Fund to pay
for critical medical treatments and basic expenses. The Black Lung
Disability Trust Fund is financed primarily by an excise tax on coal
produced and sold domestically. In both 2019 and 2020, Congress passed
1 year extensions to ensure revenue streams for the Trust Fund did not
plummet. Current rates are set to expire on December 31, 2021, putting
an indebted Trust Fund in a precarious financial situation.
How can we ensure these benefits are protected and that our coal
miners continue to get the help they need?
Answer. President Biden has consistently expressed his
understanding of the harms to individuals and communities impacted by
black lung disease. He has also expressed his belief that coal mine
companies must be responsible for the occupational harms incurred by
their workers.
When the Government Accountability Office evaluated options for
improving the Trust Fund's financial condition in May 2018, it examined
different options and noted that permanently increasing the excise tax
on coal to at least $1.38 per ton for underground-mined coal and $0.69
for surface-mined coal (25 percent higher than the current rates),
could keep the Trust Fund solvent through 2050. The Administration is
committed to ensuring coal miners continue to receive their benefits in
any case, and without a legal change, the Trust Fund will continue to
borrow from Treasury in order to finance the benefits. Without
increased funding, the GAO estimated that the Trust Fund will
accumulate $15 billion of debt by 2050. That debt would be shouldered
by taxpayers instead of the responsible coal mine companies. The
Administration is eager to work with Congress to protect these critical
benefits and ensure that the Black Lung Disability Trust Fund is
solvent.
silica dust rule
Question. The extraction, refining, and transportation of coal
generates significant amounts of coal dust, which contains silica.
While coal dust is hazardous to miners' health on its own, silica is
classed as a carcinogen and is substantially more dangerous. Excessive
exposure to silica has been linked to black lung, silicosis, and the
most lethal type of black lung, progressive massive fibrosis (PMF). The
U.S. Department of Labor's Office of Inspector General (OIG) produced
an audit report last year critical of the Mine Safety and Health
Administration's (MSHA) inadequate efforts to safeguard coal miners
from crystalline silica exposure. The Inspector General's report found
that MSHA needs to update its regulations to: (1) Lower the legal
exposure limit to silica, (2) Improve the ability of the agency to
issue citations and fines for excess exposure to silica, and (3)
Increase sampling protocols where were found to be too infrequent to
protect miners adequately. These findings are extremely troubling--
especially while we continue to grapple with the COVID-19 pandemic.
How far along is the agency in creating a silica dust standard for
underground coal mines?
Answer. The Notice of Proposed Rulemaking for MSHA's Respirable
Crystalline Silica standard is scheduled for January 2022. MSHA is in
the process of developing the proposed rule including the preamble and
supporting documentation. Under Section 101 (a) of the Federal Mine and
Safety and Health Act of 1977, the proposal must go through the notice
and comment process, which includes solicitation of comments from
stakeholders. This allows the public opportunity to submit both written
comments and to present testimony at public hearings, if requested. The
substance of the final rule would take into consideration the comments
and testimony received during the rulemaking process.
Question. When do you anticipate releasing a new rule?
Answer. The Notice of Proposed Rulemaking for MSHA's Respirable
Crystalline Silica standard is scheduled for January 2022.
miners and covid-19 protections
Question. In March 2021, the Mine Safety and Health Administration
issued Federal guidance for mine operators, but fell short of issuing
an enforceable standard that would apply to mines and miners. Last
month, the Occupational Safety and Health Administration issued an
Emergency Temporary Standard for healthcare workers, which set
requirements to protect workers from contracting COVID-19 in healthcare
settings. I introduced a bipartisan bill in February, the COVID-19 Mine
Worker Protection Act, which would require you as the Secretary of
Labor to issue an Emergency Temporary Standard to requires mine
operators to protect their workers from COVID-19. This would include
development and implementation of a comprehensive infectious disease
exposure control plan, provide PPE to miners, and a framework for
documenting data. Mining is a dangerous business, we in West Virginia
know this all too well. But we should take all appropriate steps to
ensure miners are protected against COVID-19, something we know is
continuing to spread in our country.
Secretary Walsh, can you provide an update on what are you doing to
protect miners from COVID-19 exposure in and around mining sites?
Answer. On March 10, 2021, the Mine Safety and Health
Administration issued worker safety guidance to help mine operators and
mine workers implement a coronavirus protection program and better
identify risks that could lead to exposure. ``Protecting Miners: MSHA
Guidance on Mitigating and Preventing the Spread of COVID-19'' provides
updated guidance and recommendations, and outlines existing safety and
health standards. The guidance details key measures for limiting the
coronavirus's spread, including ensuring infected or potentially
infected miners are not in the workplace, implementing and following
physical distancing protocols and using surgical masks or cloth face
coverings. It also provides guidance on use of personal protective
equipment, improving ventilation, good hygiene and routine cleaning.
MSHA announced the guidance to more than 450 stakeholders during a
quarterly meeting and answered questions from the mining community.
Question. Will you work with me on this proposal to protect miners
from COVID-19 exposure?
Answer. We need to take all appropriate steps to ensure miners are
protected from COVID-19. The state of the pandemic is in constant flux
and MSHA will follow the science. If it becomes necessary, we will
issue an Emergency Temporary Standard for COVID-19 for the mining
industry.
addiction and returning to work
Question. As the opioid epidemic continues to take its toll, there
are more and more men and women who face severely limited job
opportunities after serving their time for crimes committed as a result
of addiction. To help fix this problem, I reintroduced a bill called
the Clean Start Act that seeks to help former addicts with criminal
records seal those records if they complete a comprehensive addiction
treatment program and show that they have turned their lives around.
West Virginia has now enacted its own version of the Clean Start Act.
What are some of the key ways the Department of Labor can help in
getting those struggling with addiction to get back to work?
Answer. The public workforce system complements health, law
enforcement, and social service agencies to address the impact of
opioid addiction and other substance use disorders. Since 2018, the
Department has issued three grant opportunities addressing the
workforce impacts of opioid addiction and other substance use
disorders. Under these programs, grantees provide reemployment services
for individuals impacted by the crisis; train individuals to transition
into professions that can impact the crisis, such as alternative pain
management, mental health treatment, and addiction treatment; and
create temporary employment opportunities for peer recovery counselors
and other positions that have a direct impact on the crisis. States and
eligible applicants can continue to apply for National Health Emergency
(NHE) Dislocated Worker Grants (DWGs) at www.grants.gov. ETA encourages
State Workforce Agencies, local Workforce Development Boards, outlying
areas, and tribal organizations to develop comprehensive partnerships
to creatively align and deliver career, training, and supportive
services that will best serve workers impacted by substance use
disorders and opioid addiction. The services that the public workforce
system offers complement evidence-based treatment for substance use
disorders.
DWG grantees use two main approaches to strengthen enrollment and
services for individuals with substance use disorders: bringing
individuals into the American Job Center for tailored services, and
bringing American Job Center services to providers of behavioral health
services. DWG grantees have also reported that courts and justice-
related agencies are strong partners. These may include juvenile and
family courts, drug courts, as well as prison and probation offices.
The workforce system can connect individuals who have been involved in
the juvenile and/or adult justice system to Reentry Employment
Opportunities grant programs (where available) to receive services and
resources. These partnerships help to bridge the gap between recovery
services and employment and self-sufficiency.
For further information, ETA issued Training and Employment Notice
2-21, Serving Individuals and Communities Impacted by Opioid Addiction
and Other Substance Use Disorders, July 23, 2021. This is in addition
to a series of virtual programs in 2021 to train professionals in the
workforce system on serving individuals impacted by substance use
disorder.
Question. What programs and initiatives, in your experience, will
be most effective in assisting former offenders rejoin the workforce?
Answer. The Department's Reentry Employment Opportunities (REO)
program, which includes current reentry grants Reentry Projects,
Pathway Home, and Young Adult Reentry Partnerships, align with
evidence-based practices that result in people involved in the justice
system getting employment. Our grant programs include flexibility to
support the individualized needs of participants. Supportive services
such as transportation, housing, mental health and substance abuse
counseling, and assistance with gaining identification necessary for
employment are crucial to initial and long-term stable employment for
this population. Without these basic supports, it is hard for
participants to succeed in training that leads to better employment
outcomes. People connected to the justice system also need mentors,
especially mentors with similar lived experiences, who can support them
through the transition from incarceration to reenter the community. The
use of Work Opportunity Tax Credits and the Federal Bonding Program can
also increase employers' hiring of previously incarcerated individuals.
Moreover, connecting participants to work that is legally available
to them after release is imperative. Sometimes local or state licensure
laws present barriers to employment. The Department is currently
developing a tool that will help individuals re-entering their
communities learn how license/certification laws align with their
employment goals. The tool will be available on https://
www.careeronestop.org/.
The Department has used existing evidence to support current
initiatives, building off the Linking Employment Activities Pre-Release
(LEAP) implementation study to develop the 2020 and 2021 Pathway Home
grants. The LEAP pilots provided pre-release services through jail-
based American Job Centers and linked participants to post-release
services. The study documented effective approaches to serving
individuals in jails. The Pathway Home grants further test the
identified concepts and link participants in jails and prisons to the
workforce system while still incarcerated. Additionally, the
participants maintain the same case manager pre- and post-release for
seamless reentry into the community. Federal Bonding is also an
important tool to help justice-involved individuals overcome existing
prejudice and stigma that may prevent potential employers from hiring
them due to perceived risks.
The Reentry Projects and Pathway Home initiatives are currently
being rigorously evaluated, which will further support the evidence
base for connecting people involved with the justice system to gainful
employment. Learnings from these projects will inform future grant
models for continuous improvement and refinement of reentry employment
projects.
unemployment insurance and returning to work
Question. Mr. Secretary, it's no question that the COVID-19
pandemic has had a tremendous impact on our country since the start of
2020. Among many actions that were taken to respond to its effects, I
was proud to work with my colleagues here in Congress to provide
Americans with unprecedented relief in the form of unemployment
insurance benefit programs, which has been a needed source of income
for many West Virginians and Americans during these trying times.
However, we are noticing that in some states and localities, despite
our economy steadily returning to full, pre-pandemic capacity,
unemployment rates still remain high. This trend is, of course,
concerning, especially given the fact that the U.S. economy is adding
jobs at rates seen before the COVID-19 pandemic set in. My
understanding is that this combination of still elevated unemployment
and elevated job growth has led many states, including my state of West
Virginia, to end the pandemic unemployment assistance program before
its expiration on September 4, 2021. Like many of my colleagues, I want
to ensure that folks in my state and our country can return to work and
can do so safely. I remain willing to work with anyone and through any
means to do so.
Do you believe that the enhanced unemployment insurance programs
Congress has implemented have contributed to the inability of some
employers to fill employment vacancies?
Answer. I am not aware of evidence that enhanced unemployment
insurance programs have contributed to the inability of some employers
to fill employment vacancies. The President has said: ``I think people
who claim Americans won't work, even if they find a good and fair
opportunity, underestimate the American people. So we'll insist that
the law is followed with respect to benefits. But we're not going to
turn our backs on our fellow Americans.'' And I agree.
Question. What can we do in Congress to support the economy and our
returning workforce as we return to pre-pandemic output levels and
activity?
Answer. The COVID-19 pandemic created widespread economic
disruption and further highlighted pre-existing deficiencies in the
availability of opportunities for all Americans to find good-paying,
safe employment. While existing WIOA funding amounts to states are set
by a statutory formula, the fiscal year 2022 Budget reflects the
Department's continued commitment to help American workers and job
seekers, particularly those from disadvantaged communities, get back on
their feet, access job training, and find pathways to high-quality jobs
that can support a middle-class life. The fiscal year 2022 Budget
requests $3.7 billion for WIOA programs, a $203 million increase over
the fiscal year 2021 funding. The Budget includes increases of
approximately $37 million for the Adult Program, $94 million for the
Dislocated Worker Formula Program, $100 million for Dislocated Worker
Grants (DWG), and $43 million for the Youth Program. This request will
make employment services and training available to more dislocated
workers, low-income adults, and disadvantaged youth who have been hurt
by the economic impacts of the COVID-19 pandemic.
The fiscal year 2022 Budget also includes the American Jobs Plan,
an investment that will create millions of high-quality jobs and
rebuild our country's infrastructure. This includes investments in
American workers--providing people with the skills they need to
succeed, strengthening the pathways to success, and ensuring that the
jobs that are created are high quality. Structural racism and
persistent economic inequities have undermined opportunity for millions
of workers, and these investments will prioritize underserved
communities and communities negatively impacted by the transforming
economy. The United States currently spends just one-fifth of the
average that other advanced economies spend on workforce and labor
market programs.
The Department included legislative proposals to implement the
American Jobs Plan, totaling $81.5 billion over 10 years, to address
these multiple challenges. This investment in proven workforce
development models includes:
--Creating and expanding sector-based training programs;
--Providing comprehensive support for dislocated workers to enable
their participation in high-quality training programs;
--Expanding Registered Apprenticeship and pre-apprenticeship
opportunities;
--Building community colleges' capacity to deliver high-quality job
training programs;
--Expanding access to evidence-based intensive, staff-assisted career
services;
--Providing subsidized jobs to workers with barriers to employment;
--Expanding workforce development services for justice-involved
individuals; and
--Phasing out the subminimum wage provided to workers with
disabilities while expanding their access to competitive,
integrated employment opportunities.
The Administration also has requested $100 million in the next
fiscal year to enable states to overcome the loss of legacy industries
or persistent employment challenges and work towards a clean energy
economy, helping to ensure steady employment opportunities into the
future.
Question. Are there any lessons to be learned with how our
unemployment systems have responded over the last year to better
prepare them if faced with another economic crisis in the future?
Answer. The Unemployment Insurance system has served as a critical
lifeline over the last year, helping nearly 53 million workers stay
afloat during the pandemic and the resulting economic crisis infusing
over $800 billion into the economy--staving off an even deeper
recession. At the same time, this crisis only further exposed
longstanding challenges in the UI program. While states mobilized
quickly to implement new crucial pandemic unemployment programs, they
were hamstrung by outdated technology and a lack of resources that made
them vulnerable to fraud from international crime rings. State
administrative funding was at a historic low. Recent policy changes in
state law are designed to make it more difficult to access UI. These
challenges made it difficult for states to quickly and equitably
deliver benefits to unemployed workers. Even as economic conditions
continue to improve, states face significant backlogs that have delayed
benefits to workers, and they have struggled to address fraud
perpetrated by sophisticated crime rings that persist in using new
techniques to attack UI systems.
The Department welcomes the $2 billion that Congress provided in
the American Rescue Plan Act and agrees that UI technology and
infrastructure modernization are urgently needed. State systems must
operate on a high-quality technology infrastructure that enables them
to administer their UI programs equitably and efficiently, so all
eligible unemployed workers have timely and meaningful access to this
vital benefit. The Administration is fully engaged in developing
detailed plans to achieve the goals and purposes set in the American
Rescue Plan Act and will keep Congress informed of those plans and
progress on the implementation of this important project.
The Department has engaged with states on this topic. The
Department conducted an initial webinar with state UI agencies on June
22, 2021, to share some of the current plans and approach on pursuing
UI information technology modernization. The webinar also solicited
states for engagement and partnership in these activities. Since then,
seven states have begun working with the U.S. Department of Labor (DOL)
and the U.S. Digital Service in research partnerships designed to help
fill in research gaps and provide input on the current and future
stages of UI modernization. Also, there have been follow-up virtual
office hours offered to states for further conversations on this topic.
All states should benefit from the funding provided in the American
Rescue Plan Act. As a state modernizes its IT system, there may be
opportunities to take advantage of the central, modular, open
technology solutions developed through this DOL/state partnership. DOL
is also deploying teams of experts, initially to six states, on a
voluntary basis to help identify process improvements that can speed
benefit delivery, address equity, and fight fraud (i.e., Tiger Teams).
The Tiger Teams can provide support, including funding, as states like
West Virginia look at business processes through a fraud-fighting and
equity lens in the course of modernization. Additionally, DOL is making
grants to states available to promote equity and fight fraud. These
grants will be designed to help states improve worker access to the UI
system, while helping states make system improvements that will
safeguard them against fraud.
______
Questions Submitted by Senator Roy Blunt
apprenticeships and nontraditional industries
Question. As Chairman of the Subcommittee in fiscal year 2016, I
began funding for the Apprenticeship program. I note that while the
Administration is requesting an increase of $100 million for the
program, the Department is no longer pursuing Industry Recognized
Apprenticeship Programs (IRAPs)--which would allow third-party entities
to apply for awards without being registered by the Department of
Labor. The previous Administration argued that IRAPs are intended to
supplement the current system, not replace or weaken it. IRAPs would
also allow non-traditional apprenticeship programs to thrive alongside
of the more traditional apprenticeships.
During a period when our nation is recovering from the
unprecedented strain of COVID-19 on our workforce, it is paramount that
we provide the most opportunities to get our country back to work.
How will you work with non-traditional industries to bring them
into the Apprenticeship program?
Answer. The Department supports industry-driven and employer-led
innovation in the Registered Apprenticeship System, a key strategy to
increase the representation of non-traditional industries in Registered
Apprenticeship. In fact, expanding Registered Apprenticeship into non-
traditional industries has been a Departmental priority for the past 10
years, and we've seen incredible growth due to numerous investments and
promotional activities. Since 2015, the number of Registered
Apprenticeships in non-traditional industries (non-construction) has
grown by over 43 percent.\24\
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\24\ https://www.dol.gov/agencies/eta/apprenticeship/about/
statistics/2020.
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Industry designs and operates Registered Apprenticeship programs.
The Department works in partnership with industry to provide technical
assistance to support and ensure programs meet minimum quality
standards for apprentice safety, welfare, and equal opportunity. This
approach ensures that Registered Apprenticeship programs are employer-
led, industry-driven, of high quality, responsive to the changing needs
of employers, and capable of producing highly skilled workers that can
compete in a highly-competitive global economy.
Over the past 6 years, the Department has made significant
investments to support apprenticeship and work-based learning in non-
traditional industries. Investments include recent awards to support
state-led expansion, equity and innovation grants, innovative
approaches to developing consistent standards in non-traditional
occupations through competency-based occupational frameworks, as well
as the establishment of new Registered Apprenticeship (RA) Technical
Assistance (TA) Centers of Excellence. This includes a dedicated RA TA
Center to support the development of Registered Apprenticeship Program
frameworks (competency-based, hybrid, and other innovative models),
national standards including those that include industry-recognized
credentials, and supporting industry in meeting Registered
Apprenticeship Program design and development requirements in
compliance with 29 C.F.R. Part 29, Subpart A.
The Department has also supported employer-led innovation in
Registered Apprenticeship through the following mechanisms:
--Industry Intermediaries: Since 2016, DOL has funded industry
associations, also referred to as ``industry intermediaries''
to develop National Apprenticeship Programs to meet critical
industry needs and lead the expansion of Registered
Apprenticeship across a wide range of industries. The most
recent round of industry intermediary awards included a focus
on expanding registered apprenticeship into non-traditional
industries.
--Growth of National Programs: To better support national employers
and industry-led efforts, the Department has enabled
significant growth in the number of organizations that have
registered as National Apprenticeship Programs. This growth has
nearly doubled over the past several years. Between January
2019 and May 2021, the Department registered approximately 70
National Apprenticeship Programs. These National Apprenticeship
Programs allow employers to quickly and easily adopt industry
vetted and Departmental-approved Registered Apprenticeship
programs into their organization through a simple employer
acceptance agreement, reducing paperwork and program
duplication.
Question. What resources are needed to ensure that all
opportunities for apprenticeships are considered at the Department?
Answer. Dedicated resources for Registered Apprenticeship are
critical to expand the program. I urge Congress to enact the
President's Budget and the American Jobs Plan. Within the fiscal year
2022 President's Budget, the Administration proposes increasing
apprenticeship funding by $100 million, for a total of $285 million.
The Department will prioritize investments that expand the
apprenticeship model to new sectors and occupations and increase access
for historically underrepresented groups, including people of color,
women, individuals with disabilities, and justice-involved individuals.
The American Jobs Plan provides another opportunity for Congress to
ensure support for apprenticeship. The Administration proposes
investing $10 billion over 10 years to create between one and two
million new Registered Apprenticeship slots.
green jobs
Question. The budget request includes an increase of $100 million
within the Dislocated Worker National Reserve for a new initiative that
will target investments for training and employment opportunities in
communities for new industries, including those supporting ''green
jobs''.
Additionally, the budget request includes an increase of $20
million for a new competitive grant program to prepare eligible
veterans, transitioning service members, and their spouses for careers
in ``green jobs.'' This new competitive grant program is proposed to be
housed within Training and Employment Services, as opposed to within
the Veterans' Employment and Training Service program.
I'm concerned with the notion that the Federal Government is
dictating the future of our workforce by tying training dollars to
``green jobs.'' Specifically, the new Power initiative will impose
significant restrictions on local economies to focus only on green
jobs, and not necessarily jobs their local economy may need. The
Department already spends millions of dollars to train workers for jobs
that are needed in local communities because of the partnership with
state and local workforce boards. Therefore, why is the Federal
Government simultaneously determining what industries can prosper in
local economies through this new initiative?
Answer. The $100,000,000 requested is part of a new Interagency
Working Group on Coal and Power Plant Communities and Economic
Revitalization. The Working Group is not an attempt by the Federal
Government to determine which industries can prosper. Rather, it is an
initiative that will complement other targeted Federal investments to
assist workers and transform local economies in communities
transitioning into new, sustainable industries, including those
supporting new or sustainable energy sources. This targeted program
will help energy industry workers who have been adversely impacted by
changes in the economy prepare for jobs in demand in states and local
communities that choose to apply. The initiative will build on the
success of the original POWER initiative and expand beyond the coal
industry. It will address changes in the energy economy, and other
legacy industries, through strategic planning, partnership development,
and reskilling and reemployment activities aligned with longer-term
economic transformation efforts. It will support community-led
workforce transition, layoff aversion, job creation, and other
strategic initiatives designed to ensure economic prosperity for
workers and job seekers in the coal, oil, gas, and other industries in
decline.
Question. I'm encouraged to see an increase for veterans' programs
in the budget request. Many service members leave the military with
significant training that can translate to the civilian workforce, and
it should be a priority to ensure that our veterans have the resources
necessary to transition to civilian life. Our workforce system should
be flexible to allow these workers to succeed. However, I'm concerned
about the proposal for a new, $20 million program to train our nation's
heroes for ``clean energy'' jobs, only. I do not think we should tie
our training dollars to specific jobs, especially jobs for our
veterans, nor should the Federal Government be in the position to pick
winners and losers in the economy. Why does the Department think that
it can better dictate workforce opportunities for our transitioning
service men and women, as opposed to our local economies and the local
job creators that truly understand the workforce needs of our
communities?
Answer. The Veterans' Clean Energy Training Program will be a new
competitive grant program to prepare eligible veterans, Transitioning
Service Members (TSMs), and their spouses for careers in the clean
energy sectors of the energy industry. This program does not dictate
workforce opportunities but, instead, allows states and local
communities, based on their local workforce needs and in partnership
with local businesses, to help veterans prepare for jobs that are in
demand. Clean energy job opportunities are expected to grow between now
and 2029. Certain occupations are expected to grow rapidly in the next
several years or have large numbers of job openings. A skilled
workforce is foundational to achieving the President's goal of having
100 percent carbon-free electricity by 2035 while creating a more
resilient energy grid, lowering energy bills for middle-class
Americans, and improving air quality and public health outcomes. The
Department's Employment and Training Administration will develop and
implement the program collaboratively with the Department's Veterans'
Employment and Training Service and the Department of Veterans Affairs
to identify appropriate state, Federal, and industry partners to
deliver the education, training, and job placement of program
participants.
Grantees will use effective outreach, media, and engagement to
recruit a diverse cohort of participants for job training. Grantees
will use robust, comprehensive work-based learning strategies, such as
On-the-Job Training, customized training, Incumbent Worker Training,
Registered Apprenticeship, pre-apprenticeship programs that matriculate
to Registered Apprenticeship programs and paid work and internships.
Other allowable approaches will include classroom, including
competency-based, and technology-based training strategies, culminating
in the attainment of an appropriate industry-recognized certificate or
credential.
Grantees will also provide technical assistance to this network of
employers to successfully employ and retain veterans, TSMs, and
military spouses. In addition, grantees will provide participants with
supportive services, such as transportation and childcare, to enable
them to participate in activities authorized under the program.
The program will engage a wide array of employers, large and small,
including Veteran-Owned Small Businesses and Service Disabled Veteran
Owned Small Businesses in the adoption and deployment of training and
work-based learning. These will be public-private partnerships engaging
employers across clean energy sectors, which will help empower local
communities and ensure that we are training workers for occupations
that are in demand.
The program will develop new or expand existing successful industry
sector partnerships and build off of lessons learned from the
Department of Energy's Solar Ready Vets program. These partnerships of
multiple employers, educational institutions, economic development
agencies, workforce development entities, and community-based
organizations will identify and collaboratively meet the workforce
needs of the growing clean energy sector within a given labor market,
incorporating career pathway strategies by aligning education and
training programs with industry needs.
joint employer rule
Question. In June 2021, DOL sent its proposed rescission of the
previous Administration's Joint Employer rule to the Office of
Information and Regulatory Affairs for final rule. I am concerned that
the Department is moving to rescind the previous Administration's Joint
Employer rule and potentially issue another new rule. This
Administration's steps will further burden small and local businesses,
who are the economic drivers of our economy. As our nation recovers
from COVID-19, we need to be encouraging job growth and job creation,
not stifling it with further regulations and complicated, ambiguous
standards.
What are the Department's substantive plans and timeframe with
respect to this rulemaking?
Answer. The Department issued a final rule rescinding the previous
Administration's Joint Employer rule on July 30, 2021. The rescission
will be effective October 5, 2021.
covid-19 emergency temporary standard
Question. The Occupational Safety and Health Administration (OSHA)
published an emergency temporary standard (ETS) relating to COVID-19
protections in the workplace. The requirements of the ETS apply to
``all settings where any employee provides healthcare services or
healthcare support services.'' I am concerned that there's ambiguity
regarding who and what are exempt from the emergency rule. While retail
pharmacies have a blanket exemption, walk-in medical clinics, doctor's
offices, dental practices, and other ``non-hospital ambulatory care
settings'' may qualify for exemptions depending on their screening
policies and the type of care performed. To qualify for an exemption,
the employer must limit the number of entrances to a facility and have
a screening process where people are checked at the entrance or outside
of the facility. ``Screening'' is defined as ``asking questions to
determine whether a person is COVID-19 positive or has symptoms of
COVID-19.'' Testing is optional.
Workplaces and employers that are not exempt from this emergency
rule must develop and implement a COVID-19 plan; provide and ensure the
wear of facemasks for employees; provide respirators and other Personal
Protective Equipment to employees; ensure social distancing when
possible; install physical barriers where social distancing cannot take
place; and clean and disinfect all workplace areas in accordance with
CDC guidelines.
While I appreciate that hospitals and nursing homes must comply
with the provisions of this emergency temporary standard, as those are
the settings in which there's an increased risk of coming into contact
with an infected person, I am worried that there's too much ambiguity
as to who and what are exempt outside of those facilities. Further, the
provisions of this emergency standard place a burden on the employer,
and I'm concerned that certain workplaces that could be exempt from
these provisions may not realize it. Can you detail what settings are
exempt from this standard, and will these settings be subject to an
OSHA inspection?
Answer. The COVID-19 ETS applies to employers in settings where any
employee provides healthcare services or healthcare support services.
This includes: Employees in hospitals, nursing homes and assisted
living facilities; emergency responders; home healthcare workers; and
employees in ambulatory care facilities. The focus of the ETS is on
protecting healthcare workers in settings where suspected or confirmed
COVID-19 patients are treated. Thus, the standard targets healthcare
settings where OSHA has found the elevated risk associated with care of
persons with confirmed and suspected COVID-19, and associated
activities, constitute a grave danger. Accordingly, it exempts out
settings where this elevated risk does not exist.
Paragraph (a)(2) of the standard serves to limit the applicability
of the ETS and provides that the ETS does not apply to the following:
(i) The provision of first aid by an employee who is not a licensed
healthcare provider; (ii) the dispensing of prescriptions by
pharmacists in retail settings; (iii) non-hospital ambulatory care
settings where all non-employees are screened prior to entry and people
with suspected or confirmed COVID-19 are not permitted to enter those
settings; (iv) well-defined hospital ambulatory care settings where all
employees are fully vaccinated and all non-employees are screened prior
to entry and people with suspected or confirmed COVID-19 are not
permitted to enter those settings; (v) home healthcare settings where
all employees are fully vaccinated and all non-employees are screened
prior to entry and people with suspected or confirmed COVID-19 are not
present; (vi) healthcare support services not performed in a healthcare
setting (e.g., off-site laundry, off-site medical billing); or (vii)
telehealth services performed outside of a setting where direct patient
care occurs.
The agency has developed numerous compliance assistance materials
to help employers understand and apply the ETS to their workplace.
These materials can be found at the OSHA website.\25\ In particular,
the agency has developed a flow chart to help employers determine
whether and how their workplace is covered by the COVID-19 Healthcare
ETS. The flow chart is available on the website.\26\ The agency has
also provided responses to many Frequently Asked Questions (FAQs),
several of which address scope issues.\27\
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\25\ https://www.osha.gov/coronavirus/ets.
\26\ https://www.osha.gov/sites/default/files/publications/
OSHA4125.pdf.
\27\ https://www.osha.gov/coronavirus/ets/faqs.
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Employers that are covered by the ETS can consult the Inspection
Procedures for the COVID-19 Emergency Temporary Standard \28\
compliance directive for information about inspection procedures and
enforcement policies for the ETS. It should be noted that upon opening
a COVID-19 related inspection where the ETS could potentially apply,
the agency's enforcement personnel are specifically directed to
determine if any of the exemptions outlined in sections 29 CFR
Sec. 1910.502(a) apply to the whole facility or to well-defined
portions to ensure that the ETS is not inappropriately applied to an
employer who may be exempt.
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\28\ https://www.osha.gov/sites/default/files/enforcement/
directives/DIR_2021-02_CPL_02.pdf.
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Employers not covered by the ETS can consult the Updated Interim
Enforcement Response Plan for Coronavirus Disease 2019 (COVID-19) \29\
for more information about how OSHA is handling COVID-19-related
complaints, referrals, and severe illness reports in these workplaces.
All employers can also consult the Revised National Emphasis Program--
Coronavirus Disease 2019 (COVID-19) \30\ for more information about how
OSHA is targeting specific high-hazard industries or activities where
COVID-19 hazards are present in its enforcement activities.
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\29\ https://www.osha.gov/laws-regs/standardinterpretations/2021-
07-07.
\30\ https://www.osha.gov/sites/default/files/enforcement/
directives/DIR_2021-03_CPL_03.pdf.
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restoration of dol staffing
Question. The fiscal year 2022 budget request includes an increase
of $1.7 billion over the fiscal year 2021 level for the Department.
Included in that increase is an increase of an additional 1,949 full-
time equivalents (FTE) for the Department, increasing total FTE levels
from 14,906 to 16,855. The vast majority of the increases are within
Worker Protection components, which will ultimately increase the number
of enforcement actions against businesses.
The budget includes an additional 1,949 full-time equivalents for
the Department. 362 of those are for OSHA alone, increasing the number
of employees by over 13 percent. Most of those personnel won't focus on
training individuals to renter the workforce, which is arguably the
most important part of the Department's mission, especially as we
recover from the unprecedented strain on our economy from COVID-19. Why
is the Department not prioritizing training programs over increasing
Federal bureaucracy?
Answer. In addition to a much-needed restoration of staffing levels
in Worker Protection activities, the fiscal year 2022 Budget renews
DOL's commitment to help American workers and job seekers, particularly
those from disadvantaged communities, get back on their feet, access
job training, and find pathways to high-quality jobs that can support a
middle-class life. Significant investments in training include:
--Apprenticeship: The Budget requests $285 million, a $100 million
increase above the fiscal year 2021 enacted level, to expand
Registered Apprenticeship (RA) opportunities while increasing
access for historically underrepresented groups, including
people of color and women, and diversifying the industry
sectors involved.
--Workforce Innovation and Opportunity Act State Grants: The fiscal
year 2022 Budget also requests $3.7 billion, a $203 million
increase over the fiscal year 2021 enacted level, for Workforce
Innovation and Opportunity Act State Grants. This request will
make employment services and training available to more
dislocated workers, low-income adults, and disadvantaged youth
hurt by the economic fallout from the pandemic.
--Training displaced coal workers: The Budget requests a $100 million
investment for DOL's role in the new multi-agency POWER+
Initiative, aimed at reskilling and reemploying displaced coal
workers in Appalachian communities. This request would
complement other targeted Federal investments in POWER+ to
assist workers and transform local economies in communities
transitioning away from fossil fuel production.
--Veterans: The VETS Budget prepares America's veterans, service
members, and their spouses for meaningful careers, provides
them with employment resources and expertise, protects their
employment rights, and promotes their employment opportunities.
The Budget provides funding for the Veterans' Employment and
Training Service's (VETS) core programs, which help improve
skills and provide employment opportunities for veterans across
the country. The request also provides the Employment and
Training Administration (ETA) $20 million for a new program,
developed in collaboration with VETS and the Department of
Veterans Affairs, focused on helping veterans shift to careers
in clean energy, which would help combat climate change while
preparing veterans for good-paying jobs.
cares act and american rescue plan spending
Question. The Department of Labor received $385 million in
discretionary and mandatory supplemental funds through the CARES Act
that was passed in March 2020 and more than $2.2 billion in mandatory
funds through the American Rescue Plan (reconciliation bill) that was
passed in March 2021.
As of June 30th, a little more than $270 million has been obligated
and only $91 million has been drawn-down from the $385 million provided
in CARES. Further, of the $2.2 billion provided in the American Rescue
Plan, less than $25 million has been obligated and only $5.6 million
has been drawn-down. What is the delay in spending this funding and how
long will it take you to expend these dollars?
Answer. The CARES Act appropriated to the Department with $345.0
million for National Dislocated Worker Grants (DWGs) and $15.0 million
for the Departmental Management account to prevent, prepare for, and
respond to coronavirus, including enforcing worker protection laws and
regulations. In addition, the CARES Act appropriated $25.0 million to
the Office of Inspector General (OIG) for oversight of the unemployment
provisions enacted in the CARES Act.
The Department issued guidance to States explaining how to apply
for Disaster Recovery DWGs and Economic Recovery DWGs. The Department
accepts applications on a rolling basis. Based on the anticipated large
volume of funding requests across the nation, the Department approved
reduced initial funding amounts to address the critical community needs
in areas hardest impacted by the COVID-19 public health emergency. The
amount initially provided was 33 percent of the grant amount requested
or a set initial award amount correlated to a severity rating. The
Department typically funds DWG awards on an incremental basis, although
on rare occasions, it may award funds in full or in larger-than-typical
increments, depending on factors such as the severity of the disaster
and the viability of a proposed project.
The Department has awarded nearly $398 million in Disaster Recovery
and Economic Recovery DWGs related to COVID-19. Of this total,
approximately $143 million was obligated from the Program Year 2019
appropriation; the remainder was obligated from the supplemental funds
appropriated under the CARES Act. ETA determines the amount to award
for subsequent funding opportunities on a recipient's justification for
the additional funds and continued demonstrated need, as evidenced by
productive performance, enrollments and expenditures. ETA has
traditionally considered requests for subsequent funding opportunities
when expenditures have reached approximately 70 percent of the total
DWG funds awarded to date. ETA works closely with states in determining
their needs and identifying when additional resources may be warranted.
Of the $15.0 million appropriated to the Departmental Management
account, $1.0 million was transferred to OIG, as required. OIG's funds
are available without fiscal year limitation. The remaining $14.0
million was allocated between the Occupational Safety and Health
Administration ($5.5 million); the Employment and Training
Administration's Program Administration account ($4.0 million); the
Wage and Hour Division ($2.5 million); the Employee Benefits Security
Administration ($1.0 million); and the Office of the Solicitor ($1.0
million). These funds are available for obligation until September 30,
2022.
As of July 31, 2021, the Department has obligated approximately
$11.0 million and $9.9 million has been expended. The Department will
obligate the remaining $4.0 million over the remainder of fiscal year
2021 and fiscal year 2022 and expend the funds shortly thereafter.
Of OIG's $25.0 million CARES Act appropriation, as of July 31,
2021, OIG has obligated approximately $9.5 million and expended
approximately $5.1 million. These funds are available for obligation
until expended. The OIG indicated that it has allocated its CARES Act
appropriation to support audits and investigations related to the
expansion of the UI program during the pandemic, to include the hiring
of more than 50 criminal investigators to combat unprecedented levels
of fraud in the program. The OIG's funding will cover activities,
salaries, and benefits through the end of fiscal year 2022.
The American Rescue Plan Act (ARPA) appropriated $2.0 billion to
detect and prevent fraud, promote equitable access, and ensure the
timely payment of benefits with respect to the unemployment
compensation program, $8.0 million to carry out Federal activities
related to the administration of unemployment compensation programs,
and $200.0 million to carry out COVID-19 related worker protection
activities.
The unemployment insurance (UI) system provided a critical lifeline
for millions of workers during the pandemic. The pandemic also exposed
longstanding challenges in the UI system. The funds appropriated under
ARPA are critical to helping states address the most acute challenges
they have faced this past year. The Department will be using the funds
to tackle these acute problems facing the system in the short-term
while also working to address long-term challenges. The Department is
currently focusing on four key areas: sending multidisciplinary teams
to states to provide intensive technical assistance; a comprehensive
approach to implementing identify verification; modernizing technology;
and directing grants to states to help solve some of these challenges
immediately. Regarding the worker protection funding, the Department
has set up a website \31\ that outlines the planned use of funds for
the worker protection activities and a quarterly status of obligations.
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\31\ https://www.dol.gov/general/american-rescue-plan/worker-
protection-supplemental-appropriation.
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unemployment insurance and consumer finance applications
Question. In your testimony, you stated that you have two key goals
for unemployment insurance: decreasing fraud and increasing access to
benefits. You mentioned that the Department will have a four-pronged
approach to bolstering unemployment insurance, including modernizing
technology.
What are your thoughts on utilizing consumer finance applications
to assist states in modernizing their unemployment insurance systems
and preventing fraud?
Answer. The pandemic has only underscored states' desperate need
for technological support and improvements. Many state systems are
operating on outdated technology, which made it difficult for them to
rapidly respond to changes in law and economic conditions. Part of our
plan for the $2 billion appropriated under the American Rescue Plan Act
is to address this problem by centrally developing open, modular
technology solutions that states may adopt as part of ongoing
modernization and improvement efforts. Shared IT solutions will be
designed to integrate with state systems and will focus on the needs
that are shared across states, while supporting states to implement and
continue operating state specific elements. DOL's vision is to provide
software to support end-to-end administration of UI, including benefit
delivery, employer tools, and appeals. As part of this effort, DOL will
consider all possible IT solutions that will assist states in
modernizing their systems and preventing fraud, including consumer
finance applications. DOL will work with the IT staff in the States to
develop and execute a plan that builds resilience in the UI systems
across the country.
______
Questions Submitted by Senator Shelley Moore Capito
funding for west virginia grantees
Question. The Employment and Training Administration, an agency
within your Department, is the leading agency responsible for providing
job training and workforce development. My home state of West Virginia
has one of the highest rates of unemployment in the nation, and yet we
receive a minimal amount of ETA grant funding to retrain workers in
emerging industries as we unfortunately shift away from a coal-
dominated economy.
Why is it that we are missing out on this funding and how will you
ensure that states like West Virginia, which have a clear need for
investment in our workforce development, are adequately supported?
Answer. The Employment and Training Administration (ETA) provides
grant awards to eligible entities to carry out a public purpose for the
direct benefit or use of the United States Government. Many of these
programs are funded through formula grants whereby the law specifies or
allows ETA to determine the formula to distribute funding to the
recipients. These grants include funding under Title I of the Workforce
Innovation and Opportunity Act (WIOA), Unemployment Insurance
Administrative Awards, Foreign Labor, Employment Service, and Trade
Adjustment Assistance grants to states and territories. The allocation
formula and funding allotments for these programs are published in ETA
guidance and are made available publicly.\32\
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\32\ https://wdr.doleta.gov/directives/all_advisories.cfm.
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In addition to formula-funded programs, some legislation provides
discretionary funding for the Department to improve operations,
performance, or knowledge. These competitive grants are typically
awarded to eligible entities to create or expand innovative workforce
development programs for workers and employers. The Department develops
grant competitions and formally issues Funding Opportunity
Announcements (FOAs) that convey the application requirements and
evaluation considerations. These FOAs are published on the Grants.gov
website and provide prospective applicants with the framework for
preparing a grant application. The Department will often host a webinar
or other event to discuss new FOAs for prospective applicants during
the open period. A Technical Review Panel, composed of Federal staff
and other workforce development experts, evaluates FOA applications.
Reviewers evaluate and score applications based solely upon the
evaluation criteria in the published FOA. The ranked application scores
serve as the primary basis for the Department's selection of funding
applications.
During fiscal year 2020, ETA awarded more than $83.33 million in
grant funding to West Virginia, including $78.67 million for formula
programs and an additional $4.66 million in discretionary grants. These
awards included two grants under the Workforce Opportunities for Rural
Communities (WORC) program that enables communities within the
Appalachian and Delta regions that have been hard-hit by economic
transition, with slow recovery, to develop local and regional workforce
development solutions that align with economic development strategies.
ETA anticipates making a third round of WORC awards this Fall.
Question. On that same note, I was disappointed to learn two
YouthBuild programs weren't selected for continued funding. I'd love to
learn more about why, this program has helped so many young adults get
back on track for a career.
Answer. The Department issues the YouthBuild Funding Opportunity
Announcement (FOA) each year. This FOA is a competition open to both
previously-funded applicants and entities that never received an award.
Since this is a competitive process, not all applicants are selected
for funding. Of the 130 applications reviewed this year, due to limited
funds available, only 68 were selected. All applicants are contacted
with the results of the competition and provided guidance on how to
receive evaluative feedback related to their application. This feedback
often helps applicants submit a more competitive application in the
future.
______
Questions Submitted by Senator Mike Braun
dol freedom of information act requests
Question. The Freedom of Information Act (FOIA), codified at 5
U.S.C. Sec. 552, provides public access to certain Federal agency
information.
Please provide the Committee with the Department of Labor's (DOL)
budget request specifically for continued administration of and
compliance with FOIA requests.
Answer. The DOL's FOIA processing is a decentralized operation such
that each of the Agency's components account for their own expected
FOIA processing costs within their individual budget requests. In the
Agency's last annual FOIA report, completed for fiscal year 2020, DOL
reported a total of 120.5 Equivalent Full-Time FOIA Employees and spent
$19,103,622 in FOIA related processing costs for the DOL's 23
decentralized FOIA components,
While DOL's President's Budget for fiscal year 2022 does not
include a specific request for the aggregate cost of FOIA processing
and administration, DOL is able to identify certain items included
within its budget request that relate specifically to FOIA processing
and administration. First, for fiscal year 2022, the DOL has projected
a cost of $1,170,000 for its Office of Information Services (OIS),
which supports the statutorily mandated functions of the Department's
Chief FOIA Officer (currently the Solicitor) in carrying out
Department-level responsibilities under the Freedom of Information Act.
5 U.S.C. Sec. 552. In addition, DOL's Office of the Chief Information
Officer (OCIO) has projected fiscal year 2022 FOIAXpress System cost to
be $1,121,576, to include $891,210 for FOIA System Costs (Licensing and
Hosting), $155,366 for FOIA.
Question. Pertaining to the January 1, 2021 to July 15, 2021
timeframe, please also provide:
1. An update on the volume of FOIA requests;
2. The average time the agency took to fulfill such and the
volume of FOIA requests outstanding; and
3. How many requests the agency has utilized a statutory
exemption to deny fulfillment of a FOIA request.
Answer.
1. An update on the volume of FOIA requests
------------------------------------------------------------------------
Total Number of Initial FOIA Requests Received............. 7,632
Total Number of Initial FOIA Requests Processed............ 8,442
------------------------------------------------------------------------
``Total Number of Initial FOIA Requests Processed'' includes requests
received prior toP January 1, 2021.
2. The average time the agency took to fulfill such and the
volume of FOIA requests outstanding:
------------------------------------------------------------------------
Average Number of Days to Process (Simple Queue)........... 45.8
Average Number of Days to Process (Complex Queue).......... 72.2
Average Number of Days to Process (Expedited Queue)........ 79.1
Total Number of Pending Requests (outstanding) request..... 2,296
Total Number of Backlogged Requests (20 workdays or older). 1,503
------------------------------------------------------------------------
``Simple Queue'' is based on low volume and/or simplicity of records
requested and ``Complex Queue'' is based on high volume and/or
complexity of records requested.
3. How many requests the agency has utilized a statutory
exemption to deny fulfillment of a FOIA request: 2
Question. Please also provide a comparison of such FOIA volume and
related fulfillment to calendar year 2020.
Answer.
1. An update on the volume of FOIA requests
------------------------------------------------------------------------
Total Number of Initial FOIA Requests Received............. 15,820
Total Number of Initial FOIA Requests Processed............ 15,645
------------------------------------------------------------------------
2. The average time the agency took to fulfill such and the
volume of FOIA requests outstanding:
------------------------------------------------------------------------
Average Number of Days to Process (Simple Queue)........... 39
Average Number of Days to Process (Complex Queue).......... 53.3
Average Number of Days to Process (Expedited Queue)........ 18.8
Total Number of Pending Requests (outstanding)............. 2,589
Total Number of Backlogged Requests (20 workdays or older). 1,714
------------------------------------------------------------------------
3. How many requests the agency has utilized a statutory
exemption to deny fulfillment of a FOIA request: 0
payroll audit independent determination program
Question. In the Trump Administration, the Department of Labor's
Wage and Hour Division (WHD) saw both record-breaking enforcement
numbers, and record-breaking outreach efforts. Despite these incredible
outcomes for workers, the Biden Administration ended a voluntary
compliance program called PAID (Payroll Audit Independent
Determination). Will you commit to reviewing and reestablishing the
PAID program?
Answer. The Department ended the Payroll Audit Independent
Determination (PAID) program in January 2021. Between 2018 and 2021,
approximately 70 employers participated in the PAID program. The
Department continues to provide outreach and education resources for
employers. Employers may continue to contact any of our 200 Wage and
Hour Division offices to confidentially discuss their compliance
questions, or to self-report violations they would like to resolve.
teleworking
Question. How many of DOL's approximately 15,279 Full Time
Equivalent (FTE) person workforce in Washington, D.C. is currently
teleworking either (1) part-time or (2) full-time?
Answer. Based on data from the end of July 2021, 99.1 percent of
DOL and PGBC employees are teleworking either on a part-time or full-
time basis.
Question. For part-time staff, what proportion of their time is
spent teleworking, on average?
Answer. Pre-pandemic, part-time employees spent 21 percent of their
time teleworking. During the maximum telework posture, part-time
employees spent 92 percent of their time teleworking.
Question. What has such teleworking done to decrease commuting and
parking reimbursements, energy consumption, and other expenditures
compared to years prior to the pandemic?
Answer. Transit subsidy costs have decreased and these funds have
been reinvested by agencies in their program activities. There have
been some savings in energy consumption related to the reduction in on-
premises staff. To comply with safety recommendations from the Centers
for Disease Control and Prevention in response to the COVID-19
pandemic, however, the Heating, Ventilation and Air Conditioning system
is now run 24 hours a day to increase ventilation in the building. This
has increased energy usage overall from prior years.
secretary's calendar
Question. Previous administrations posted the calendars of their
agency head for public inspection. As of July 23, 2021, there is no
calendar information available to the public to understand your daily
efforts on the public's behalf.
Will you commit to begin sharing your calendar information with the
public on the DOL website? Can you provide a date on which your
calendar detailing the first several months of your tenure will be
published publicly?
Answer. No later than September 29, 2021, Secretary Walsh's
calendar will be available at https://www.dol.gov/general/foia/
readroom.\33\ This will include the Secretary's calendar dating back to
March 23, 2021 through July 31, 2021. Moving forward the calendars will
be updated on a monthly basis.
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\33\ https://www.dol.gov/general/foia/readroom.
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unemployment insurance and third-party income verification
Question. Pandemic Unemployment Assistance (PUA) has brought
Unemployment Insurance (UI) eligibility to a significant number of
``gig'' or 1099 workers. These workers often face the greatest lag
between income loss and access to benefits.
Some have suggested using consumer finance applications (apps) to
reduce processing overhead, decrease fraud, and enable automation
resulting in streamlined access to benefits.
Do you believe that states should use available funds to modernize
UI systems and prevent fraud by creating partnerships with such
consumer finance apps?
Answer. The pandemic has only underscored states' desperate need
for technological support and improvements. Many state systems are
operating on outdated technology, which made it difficult for them to
rapidly respond to changes in law and economic conditions. Part of our
plan for the $2 billion appropriated under the American Rescue Plan Act
is to address this problem by centrally developing open, modular
technology solutions that states may adopt as part of ongoing
modernization and improvement efforts. Shared IT solutions will be
designed to integrate with state systems and will focus on the needs
that are shared across states, while supporting states to implement and
continue operating state specific elements. DOL's vision is to provide
software to support end-to-end administration of UI, including benefit
delivery, employer tools, and appeals. As part of this effort, DOL will
consider all possible IT solutions that will assist states in
modernizing their systems and preventing fraud, including consumer
finance applications. DOL will work with the IT staff in the States to
develop and execute a plan that builds resilience in the UI systems
across the country.
Question. Is the Department of Labor considering issuing guidance
in regard to the ability of the states to use third-party income
verification technology to accurately verify 1099 and gig worker income
distribution?
Answer. Within the scope of the temporary Pandemic Unemployment
Assistance (PUA) program authorized by the Coronavirus Aid, Relief, and
Economic Security (CARES) Act, as amended, DOL has advised states
through webinars and individual technical assistance requests regarding
the use of third parties when obtaining documentation to verify 1099
income distribution for purposes of eligibility. Because the Department
has already provided information to states on using third parties to
verify income for PUA claimants and the program will end shortly, the
Department does not plan on issuing guidance on using third party
income verification technology.
______
Questions Submitted by Senator Patrick J. Leahy
unemployment insurance it modernization
Question. The COVID-19 pandemic highlighted the cracks in the
foundation of many critical support systems across all levels of
government, including the unemployment insurance system. After 15 very
long months, Vermont is finally back to its pre-pandemic unemployment
levels of 2.6 percent. The State has reinstated its work search
requirements, and plans to allocate Federal unemployment benefits
through the summer.
In April, your Department contacted the Vermont Department of Labor
requesting that they re-process thousands of Federal unemployment
benefit claims. During this difficult and unprecedented time, the state
was trying to get money out the door to people in need as fast as they
could. I, along with the rest of the Vermont congressional delegation,
wrote you in late April about the need for flexibility when it came to
the reprocessing of unemployment insurance claims given to claimants
for the ``able and available'' eligibility criteria.
While the response from your Department recognized the strain under
which state UI programs are operating, and stated that you will
continue to provide the state with technical assistance to fulfill the
Department's request, the Vermont delegation did not receive a response
to our inquiry until last week, on July 7. I appreciate your
Department's willingness to work with the state, but this was a long-
delayed response. I hope the Department will keep me and my staff
updated on this issue, as the state is doing, and in the future, I hope
the responses to my office will be received in a timelier manner.
One issue highlighted by the pandemic is how many smaller, rural
states including Vermont lack adequate, modern unemployment insurance
technology. While trying to process thousands of new unemployment
claims, the Vermont Department of Labor, for example, had to work with
a 50-year-old computer mainframe that repeatedly froze and crashed the
system at the beginning of the pandemic in the spring of 2020. I
appreciate your Department's request for $100 million to bolster state
Department of Labor's IT systems to administer unemployment, which is
on top of the $2 billion committed in the American Rescue Plan for the
same purpose.
How will your Department work to ensure that departments of labor
with older unemployment insurance IT systems, such as Vermont's 50-
year-old mainframe, are prioritized when administering UI modernization
funding?
Answer. The Department welcomes the $2 billion that Congress
provided in the American Rescue Plan Act and agrees that UI technology
and infrastructure modernization is urgently needed. It is critical
that state systems operate on a high-quality technology infrastructure
that enables them to administer their UI programs equitably and
efficiently, so all eligible unemployed workers have timely and
meaningful access to this vital benefit. Formulating large scale
spending plans across the UI system, which is comprised of 53 different
programs operated by the states, the District of Columbia, Puerto Rico,
and the U.S. Virgin Islands, requires multiple complex considerations.
The Administration is fully engaged in developing detailed plans to
achieve the goals and purposes set in the American Rescue Plan Act and
will keep Congress informed of those plans and progress on the
implementation of this important project.
The Department has engaged with states on this topic. The
Department conducted an initial webinar with state UI agencies on June
22, 2021, to share some of the current plans and approach on pursuing
UI information technology modernization. The webinar also solicited
states for engagement and partnership in these activities. Since then,
seven states have begun working with the U.S. Department of Labor (DOL)
and the U.S. Digital Service in research partnerships designed to help
fill in research gaps and provide input on the current and future
stages of UI modernization. Also, there have been follow-up virtual
office hours offered to states for further conversations on this topic.
All states should benefit from the funding provided in the American
Rescue Plan Act. As a state modernizes its IT system, there may be
opportunities to take advantage of the central, modular, open
technology solutions developed through this DOL/state partnership. DOL
is also deploying teams of experts, initially to six states, on a
voluntary basis to help identify process improvements that can speed
benefit delivery, address equity, and fight fraud (i.e., Tiger Teams).
The Tiger Teams can provide support, including funding, as states like
Vermont look at business processes through a fraud-fighting and equity
lens in the course of modernization. Additionally, DOL is making grants
to states available to promote equity and fight fraud. These grants
will be designed to help states improve worker access to the UI system,
while helping states make system improvements that will safeguard them
against fraud.
workforce shortages
Question. Even as Vermont's unemployment rate has fallen back to
pre-pandemic levels, workforce shortages remain and no sector has been
spared. Businesses in smaller, more rural states like Vermont, have
struggled for decades to address skilled workforce shortages--whether
it is in the healthcare, education, child care, or manufacturing
industry. Your Department's budget requests $3.7 billion, a 6 percent
increase, for the Workforce Innovation and Opportunity Act and Wagner
Peyser state formula grants to make employment services and training
available to dislocated workers impacted by the COVID-19 pandemic.
How will your Department work to ensure that the DOL's workforce
development help dislocated workers in rural states like Vermont that
currently lack the services available to provide workers with the
skills necessary to re-enter the post-pandemic economy?
Answer. The Department is working to ensure that all American
workers and job seekers, including those in Vermont, have access to the
services needed to make them ready for good jobs with family-sustaining
wages. The COVID-19 pandemic created widespread economic disruption and
further highlighted pre-existing deficiencies in the availability of
opportunities for all Americans to find good-paying, safe employment.
While WIOA funding allotments to states are set by a statutory formula,
the fiscal year 2022 Budget reflects the Department's continued
commitment to help American workers and job seekers, particularly those
from disadvantaged communities, get back on their feet, access job
training, and find pathways to high-quality jobs that can support a
middle-class life. The fiscal year 2022 Budget requests $3.7 billion
for WIOA programs, a $203 million increase over the fiscal year 2021
funding. The Budget includes increases of approximately $37 million for
the Adult Program, $94 million for the Dislocated Worker Formula
Program, $100 million for Dislocated Worker Grants (DWG), and $43
million for the Youth Program. This request will make employment
services and training available to more dislocated workers, low-income
adults, and disadvantaged youth who have been hurt by the economic
impacts of the COVID-19 pandemic.
The fiscal year 2022 Budget also includes the American Jobs Plan,
an investment that will create millions of high-quality jobs and
rebuild our country's infrastructure. This includes investments in
American workers--providing people with the skills they need to
succeed, strengthening the pathways to success, and ensuring that the
jobs that are created are high quality. Structural racism and
persistent economic inequities have undermined opportunity for millions
of workers, and these investments will prioritize underserved
communities and communities negatively impacted by the transforming
economy. The United States currently spends just one-fifth of the
average that other advanced economies spend on workforce and labor
market programs.
The Department included legislative proposals to implement the
American Jobs Plan, totaling $81.5 billion over 10 years, to address
these multiple challenges. This investment in proven workforce
development models includes:
--Creating and expanding sector-based training programs;
--Providing comprehensive support for dislocated workers to enable
their participation in high-quality training programs;
--Expanding Registered Apprenticeship and pre-apprenticeship
opportunities;
--Building community colleges' capacity to deliver high-quality job
training programs;
--Expanding access to evidence-based intensive, staff-assisted career
services;
--Providing subsidized jobs to workers with barriers to employment;
--Expanding workforce development services for justice-involved
individuals; and
--Phasing out the subminimum wage provided to workers with
disabilities while expanding their access to competitive,
integrated employment opportunities.
There are several current funding sources that may be able to
support rural communities in addressing workforce transition.
First, each state may reserve up to 15 percent of their WIOA
funding for statewide activities and an additional 25 percent of the
Dislocated Worker formula allotment for Rapid Response activities. Both
statewide and Rapid Response activities can be focused on prioritizing
business engagement activities and layoff aversion efforts. Business
engagement helps to develop long-term relationships with the business
community. It enables the public workforce system to partner with
businesses to play a more significant part in understanding their
workforce needs, both currently and in the future. Statewide resources,
or other WIOA resources, can then be used to train workers in the
specific skills these businesses need.
Second, state or local workforce areas may request additional
funding from the Department through the National Dislocated Worker
Grant (DWG) program when qualifying events occur, including large
layoffs or a number of smaller layoffs that add up to a larger impact.
DWG funds supplement the regular WIOA formula resources and allow
states to provide critical workforce services to more unemployed
workers than would otherwise be the case.
Lastly, the Department funds several other grant programs that may
benefit rural states and communities across the country. For example,
on June 28, 2021, the Department announced the Comprehensive and
Accessible Reemployment through Equitable Employment Recovery (CAREER)
DWG. CAREER DWGs are designed to fund strategies and activities to help
reemploy dislocated workers most affected by the economic and
employment fallout from the COVID-19 pandemic, in particular, those
from historically marginalized communities or groups and those who have
been unemployed for an extended period or who have exhausted UI or
other Pandemic Unemployment Insurance programs.
Another example is the competitive H-1B Rural Healthcare grants. In
January 2021, the Department awarded $40 million in funding to rural
communities through partnerships of public and private entities to
address rural healthcare workforce shortages across the country. This
investment is addressing a very specific need that was exacerbated
during the pandemic. It aims to increase the number of individuals
training in healthcare occupations that directly impact patient care
and alleviate healthcare workforce shortages by creating sustainable
employment and training programs in healthcare occupations serving
rural populations.
The Administration also has requested $100 million in the next
fiscal year to enable states to overcome the loss of legacy industries
or persistent employment challenges and work towards a clean energy
economy, helping to ensure steady employment opportunities into the
future.
regional apprenticeship program
Question. A primary focus of the Department of Labor's budget
request for fiscal year 2022 is a significant increase of Federal
funding for the Registered Apprenticeship Program of $100 million,
totaling $285 million for the program, which is a 154-percent increase
from fiscal year 2021. Apprenticeship programs add to the important
workforce development role in helping people succeed in learning for
the jobs of today and tomorrow. Many states, including Vermont, must
connect jobseekers to better paying jobs that are in high-demand in
order to continue to have a healthy economy. More than 90 percent of
apprentices find employment after completing their programs, with
graduates earning an average starting salary of more than $60,000.
The fiscal year 2022 budget request highlights the need for the
Registered Apprenticeship Program to focus on expanding access to the
model for historically underrepresented groups, including women and
people of color, and in high-growth sectors where apprenticeships are
underutilized. Despite the need for innovative programs to stem the
demographic trends of aging and shrinking rural areas, small rural
states such as Vermont have struggled with meeting some of the criteria
for the Department's Apprenticeship program. Expanding the Department's
partnership with regional commissions would ensure that small rural
areas can also build long-term community capacity and increase economic
competitiveness.
What is the Department's plan for ensuring that the increased
funding request for the Registered Apprenticeship Program also benefits
people who live in small rural states where the program's criteria has
historically been a barrier to access?
Answer. The Department is acutely aware of the need for improving
conditions in rural areas and reaching underserved populations and has
previously invested in the expansion of Registered Apprenticeships in
states, including small rural states, and is committed to continuing
these efforts through future grant funding.
Previously, the Department awarded several grants supporting
efforts to address access barriers to Registered Apprenticeship
Programs in rural areas. These include Registered Apprenticeship grants
awarded to states in 2016, 2018, 2019, and 2020 \34\ to support
building state capacity to expand Registered Apprenticeship. The
Vermont Department of Labor was a recipient of these awards in each of
those 4 years. Since 2016, according to the Department's records the
State of Vermont has seen a nearly 70 percent increase in the number of
active apprentices in Registered Apprenticeship programs, including
over 2,600 new apprentices during this period. In addition, in January
2021, the Department awarded nearly $40 million in grants as part of
the H-1B Rural Healthcare grant program, focused on addressing
healthcare workforce shortages by creating sustainable employment and
training programs in healthcare occupations serving rural populations.
This funding opportunity allowed applicants to propose a wide range of
training models, including Registered Apprenticeship Programs (RAPs)
to, meet the healthcare workforce needs of rural areas.
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\34\ https://www.apprenticeship.gov/investments-tax-credits-and-
tuition-support/active-grants-and-contracts.
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Most recently, the Department awarded more than $99 million to
states as part of the State Apprenticeship Expansion, Equity, and
Innovation \35\ grants to bolster states' efforts to expand programming
and inclusive recruitment strategies to attract a diverse workforce.
The awards include more than $85 million for states that demonstrated a
commitment to increasing their diversity, equity and inclusion efforts.
These grants also aim to develop partnerships with new industries and
non-traditional occupations, including industry sectors hardest hit by
the pandemic, and align Registered Apprenticeships with other work-
based learning opportunities within state education and workforce
systems. In addition, to ensure this funding opportunity could support
the diverse needs of small rural states, medium-sized, and large states
the funding opportunity allowed for a broad funding request range (from
$2 million up to $10 million) with performance outcome targets that
were commensurate with the amount of funding requested.
---------------------------------------------------------------------------
\35\ https://www.apprenticeship.gov/investments-tax-credits-and-
tuition-support/active-grants-and-contracts.
---------------------------------------------------------------------------
Further, to better facilitate the expansion of Registered
Apprenticeship, including in rural areas, the Department also awarded
nearly $31 million through cooperative agreements to establish four
Registered Apprenticeship (RA) Technical Assistance (TA) Centers of
Excellence \36\ to provide technical assistance to key apprenticeship
stakeholders. These RA TA Centers of Excellence will provide technical
assistance on a national scale focused on: (1) diversity and inclusion;
(2) strategic partnership and system alignment; (3) apprenticeship
occupations and standards; and (4) data and performance best practices.
Rural areas, as well as all states, will benefit from the technical
assistance being provided by these centers.
---------------------------------------------------------------------------
\36\ https://www.apprenticeship.gov/investments-tax-credits-and-
tuition-support/active-grants-and-contracts.
---------------------------------------------------------------------------
A focus of all of the Department's investments awarded in 2021 is
to fund opportunities to support innovation in Registered
Apprenticeship expansion efforts allowing states maximum flexibility
for determining where they should target resources. Such efforts may
include creating access for underrepresented populations; developing
distance learning approaches; identifying promising practices with
employer incentives that could bring employers on board, especially in
rural areas; and ensuring industries or occupations negatively impacted
by the COVID-19 pandemic are supported.
In fiscal year 2022, the Department will prioritize investments
that continue to expand the capacity of states to build and expand the
apprenticeship model to new sectors and occupations, increase access
for historically underrepresented groups; and address access barriers
to Registered Apprenticeship Programs in rural areas. The Department
will continue looking for additional opportunities to further these
efforts.
Question. Has the Department considered further utilizing its
partnerships with regional commissions and authorities to expand access
to vital workforce development programs such as the Regional
Apprenticeship Program? How can these partnerships best be utilized?
Answer. The Department believes partnerships that support workforce
system integration are critical to expand access to Registered
Apprenticeship Programs. This includes building partnerships with
governors, workforce agencies, workforce development boards, and
interdepartmental Federal leaders to further align registered
apprenticeship with other work-based learning opportunities within
state education and workforce systems.
As these partnerships are critical to expanding access to
Registered Apprenticeship Programs, the Department has and will
continue to fund activities that support building strategic
partnerships and system alignment. Most recently, the Department
awarded more than $99 million to states as part of the State
Apprenticeship Expansion, Equity, and Innovation \37\ (SAEEI) grants to
bolster states' efforts to expand programming and inclusive recruitment
strategies to attract a diverse workforce. Under these grants, states
must explore new and expanded opportunities with industry, employers,
education and training providers, the workforce system, state and local
governments, labor organizations, and other entities, to better
coordinate and maximize resources and assistance across Federal, state
and local funding streams, as well as from the private sector
enrollment in and access to apprenticeship opportunities that support
workforce system integration.
---------------------------------------------------------------------------
\37\ https://www.apprenticeship.gov/investments-tax-credits-and-
tuition-support/active-grants-and-contracts.
---------------------------------------------------------------------------
Additionally, the Department also awarded nearly $31 million
through cooperative agreements to establish four Registered
Apprenticeship (RA) Technical Assistance (TA) Centers of Excellence
\38\ to provide technical assistance to key apprenticeship
stakeholders. One of the RA TA Centers funded will support strategic
partnerships and system alignment. Specifically, this center will focus
on establishing, building, and sustaining partnerships that support
system alignment of the national workforce and education systems to
accelerate Registered Apprenticeship Program adoption and expansion.
This RA TA Center of Excellence will provide technical assistance on a
national scope to Registered Apprenticeship Program sponsors, and will
also support state and local workforce development boards, American Job
Center programs and operators, governors and other essential
stakeholders that drive and inform economic and workforce development
policies and programs.
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\38\ https://www.apprenticeship.gov/investments-tax-credits-and-
tuition-support/active-grants-and-contracts.
---------------------------------------------------------------------------
The Department is constantly striving to find new and better ways
to connect with the workforce system and its partners.
SUBCOMMITTEE RECESS
Senator Murray. With that, the subcommittee is adjourned.
[Whereupon, at 11:12 a.m., Wednesday, July 14, the hearings
were concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]
DEPARTMENT OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2022
----------
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
[Clerk's note.--The subcommittee was unable to hold
hearings on departmental and nondepartmental witnesses. The
statements and letters of those submitting written testimony
are as follows:]
DEPARTMENTAL WITNESSES
Prepared Statement of America's Public Television Stations and
the Public Broadcasting Service
On behalf of America's 158 public television licensees, we
appreciate the opportunity to submit testimony for the record on the
importance of federal funding for local public television stations and
PBS (Public Broadcasting Service). We urge the Subcommittee to support
$565 million in two-year advance funding for the Corporation for Public
Broadcasting (CPB) in FY 2024, $20 million for the Public Broadcasting
Interconnection System in FY 2022 and $30 million for the Ready To
Learn program at the Department of Education in FY 2022.
corporation for public broadcasting: $565 million (fy 2024)
two-year advance funded
Public television plays a key role in educating our children;
providing job training; preserving our diverse, dynamic culture and
democracy; and keeping Americans informed, safe and healthy. Public
television's essential services have never been more critical than
during the COVID-19 pandemic, when local public television stations in
all 50 states provided enhanced educational services and content to
help support students, families, teachers, and schools with the sudden
challenge of virtual learning.
Federal funding for CPB is essential to making these services
available to all Americans, including those in rural and underserved
areas, and this funding enjoys the overwhelming support of the American
people. At about $1.40 per person per year, this funding provides an
enormous return on investment for all Americans.
Yet these vital community-based services were level-funded at $445
million for a decade--resulting in an approximate $100 million in lost
purchasing power.
Recognizing this loss, we appreciate that Congress increased the
forward funded CPB appropriation by $20 million for FY 2022 and an
additional $10 million for FY 2023.
While public broadcasting is grateful for these increases, The
public broadcasting system is still about $75 million, in inflation-
adjusted dollars, behind where the system was 10 years ago, at a time
when it is bearing the costly expense of providing access to content on
ever emerging platforms and stations continue to offer more and more
essential services to their communities.
Public broadcasting respectfully requests that Congress take
another substantial step toward securing our current and future public
service goals in the FY 2022 appropriations process.
The $565 million that public broadcasting is requesting in FY 2022
for FY 2024 will help restore lost purchasing power and enable local
stations to leverage advancements in technology and make investments in
the future that will educate more children and adults, provide
additional critical resources and capabilities to teachers and schools,
further enhance public safety and expand the civic leadership work of
local stations.
Given the success of public media, and its potential to do so much
more for so many, it is sound public policy to increase federal funding
for this valuable service that provides an exceptional return on
investment.
Education
Public media is committed to education and service for all
Americans. Public broadcasting allows people at all income levels and
from all parts of the country-rural and urban-to have access to
consistent, high-quality, diverse content for free. This educational
programming is readily available to children, parents, teachers, senior
citizens, those pursuing their high school equivalency degrees, and
many others.
Since last spring, as schools across the country shifted to remote
learning in the face of the COVID-19 pandemic, local public television
stations rolled out new education initiatives, including curated At-
Home Learning broadcasts, airing instructional lessons created by
teachers, and educational datacasting pilots to serve students without
internet connectivity. These resources provided critical support to
schools, teachers, and parents and helped bridge the digital gap for
rural and underserved students. This extraordinary response by public
television stations, many of which partnered with state and local
education agencies, has provided much needed educational resources and
support in communities across the country.
Public television's educational broadcast content has helped more
than 90 million pre-school age children get ready to learn and succeed
in school. Beyond the iconic, proven educational programming, PBS, in
partnership with local public television stations and school districts
provides additional content directly to classrooms and homes through
PBS LearningMedia--which provides access to tens of thousands of State
curriculum-aligned digital learning objects--including videos,
interactives, lesson plans and more--for use in K-12 classrooms and at
home. Content is sourced from the best of public television in addition
to material from the Library of Congress, National Archives, NASA and
other high-quality sources. PBS LearningMedia provided teachers and
students with critical resources and digital content and the number of
users grew by 240% during the pandemic.
Additionally, local public television stations throughout the
country have partnered with PBS to bring a first-of-its kind, free PBS
KIDS 24/7 channel and live stream to their communities--providing kids
throughout the country with the highest level of educational
programming, available through local stations any time, over-the-air
and streaming. During the COVID-19 pandemic, many stations are using
this expanded broadcast capacity to directly serve families and
students from Pre-K--12 with state standards aligned educational
content and instructional content created by teachers. Last year, 60%
of kids ages 2-8 watched PBS KIDS content. Parents also looked to
public television for educational resources, with PBS Parents users
increasing by 80% during the pandemic.
Public television stations are also leaders in adult education.
Public television operates the largest nonprofit GED program in the
country, helping tens of thousands of second-chance learners earn their
high school equivalency degree. In addition, public television stations
are leaders in workforce development, including retraining American
veterans, by providing digital learning opportunities for training,
licensing, continuing education credits, soft skills and more.
Partners in Public Safety
Public broadcasting stations throughout the country are leading
innovators and essential partners to local public safety officers. In
partnership with FEMA, PBS WARN uses the public television
interconnection system and local stations' broadcast infrastructure to
support the Wireless Emergency Alert (WEA) system that enables cell
subscribers to receive geo-targeted text messages in the event of an
emergency-reaching citizens wherever they are.
The February 2019 Report from the FEMA National Advisory Council on
Modernizing the Nation's Public Alert and Warning System specifically
recommends, ``Encouraging use of public media broadcast capabilities to
expand alert, warning, and interoperable communications capabilities to
fill gaps in rural and underserved areas.''
In addition, and separate from the WEA system, local public
television stations' digital infrastructure and spectrum enable them to
provide state and local officials with critical emergency alerts,
public safety, first responder and homeland security services and
information during emergencies through a process known as datacasting.
Datacasting uses broadcast spectrum to send encrypted data and video to
first responders with no bandwidth constraints.
In partnership with local public television stations and local law
enforcement agencies, the U.S. Department of Homeland Security (DHS)
has conducted several successful pilots throughout the country that, in
addition to other local initiatives, prove the effectiveness of
datacasting in a range of use cases including: flood warning and
response; enhanced 911 responsiveness; over-water communications;
faster early earthquake warnings; multiagency interoperability; rural
search and rescue; high profile, large event crowd control; and
assistance with school safety, including in areas that lack broadband
or LTE services.
As a result of the successful pilots, the DHS Science and
Technology Directorate has partnered with America's Public Television
Stations (APTS) to maximize and promote datacasting technology and the
opportunity to partner with local public television stations in
communities nationwide.
Additionally, stations are increasingly partnering with their local
emergency responders to customize and utilize public television's
infrastructure for public safety in a variety of critical ways, with
many serving as their states' Emergency Alert Service (EAS) hub for
weather and AMBER alerts.
Providing Civic Leadership
Public television strengthens the American democracy by providing
citizens with access to the history, culture and civic affairs of their
communities, their states and their country. Through the pandemic,
public television has been providing essential front-line coverage to
ensure Americans have the facts they need to stay healthy and local
information on where they can turn for help if they need it.
For the 18th year in a row, PBS was ranked the most trusted among
national institutions. That trust is more important than ever. Over the
last year, when inaccurate information could endanger people's lives,
Americans could tune into their local public television station or view
their online resources for trusted information that could help keep
them safe.
Local public television stations often serve as the state-level
``C-SPAN'' covering state government actions. As some of the last
locally controlled media, public television stations also provide more
public affairs programming, forums for discussion of local issues such
as the opioid crisis, local history, arts and culture, candidate
debates, agricultural news, and citizenship information of all kinds
than anyone else. What truly sets public television stations apart is
that stations treat their viewers as citizens rather than consumers.
Public Broadcasting is a Smart Investment
All of this public service is made possible by the federal funding
to CPB. This federal investment sustains the public service missions of
public television, which are distinct from the mission of commercial
broadcasting and will not be funded by private sources, as the
Government Accountability Office concluded in a 2007 study commissioned
by Congress.
The need for federal investment is particularly acute in small-town
and rural America, where lower population density, a lack of corporate
and philanthropic support, and challenging topography make the
economics of local television and public service more challenging. As a
result, public broadcasters are sometimes the only local broadcaster
serving rural communities-and only with the help of the federal
investment.
For all stations, federal funding is the ``lifeblood'' of public
broadcasting, providing indispensable seed money to stations to build
additional support from state legislatures, foundations, corporations,
and ``viewers like you.''
For every dollar in federal funding, local stations raise six
dollars in non-federal funding, creating a strong public-private
partnership providing a valuable return on investment and supporting
approximately 20,000 jobs across America.
And yet, until two years ago, this critical funding remained flat
for a decade, forcing stations to make difficult programming, staffing
and service decisions as operational costs rose with inflation, while
CPB funding did not. Despite this severe financial constraint, local
public television stations have continued their deep commitments to the
communities they serve.
The $565 million that public broadcasting is requesting in FY 2024
is both prudent and necessary for the continued health of local
stations and the public broadcasting system as a whole--and for long-
delayed enhancements of the essential education, public safety and
civic leadership services described above.
Two-Year Advance Funding
Two-year advance funding is essential to the mission of public
broadcasting. This longstanding practice, proposed by President Ford
and embraced by Congress in 1976, establishes a firewall insulating
programming decisions from political interference, enables the
leveraging of funds to ensure a successful public-private partnership,
and provides stations with the necessary lead time to plan in-depth
programming and accompanying educational materials-all of which
contribute to extraordinary levels of public service and public trust.
Local stations leverage the two-year advance funding to raise
state, local and private funds, ensuring the continuation of this
strong public-private partnership. These federal funds act as the seed
money for fundraising efforts at every local station, no matter its
size. Advance funding also benefits the partnership between states and
stations since many states operate on two-year budget cycles.
Finally, the two-year advance funding mechanism gives stations and
producers, both local and national, the critical lead time needed to
raise the additional funds necessary to sustain effective partnerships
with local community organizations and engage them around high-quality
programs. Producers like Ken Burns, Henry Louis Gates, Jr. and Stanley
Nelson, spend years developing programs like The Vietnam War, Country
Music, The Black Church, Tell Them We Are Rising: The Story of Black
Colleges and Universities and a documentary on Muhammed Ali airing this
fall. It would be impossible to produce this in-depth programming and
the curriculum-aligned educational materials that accompany it without
the two-year advance funding.
public broadcasting interconnection: $20 million
The public television interconnection system is the infrastructure
that connects PBS and national, regional and independent producers to
local public television stations around the country. The
interconnection system is essential to bringing public television's
educational, cultural and civic programming to every American
household, no matter how rural or remote. Without interconnection,
there is no nation-wide public media service. The interconnection
system is also critical for public safety, providing key redundancy for
the communication of presidential alerts and warnings, and ensuring
that cellular customers can receive geo-targeted emergency alerts and
warnings.
Congress has always provided federal funding for periodic
improvements of the interconnection system. In FY 2018, Congress moved
to fund interconnection for public broadcasting on an annual, rather
than decennial, basis to enable dynamic, incremental upgrades in accord
with increasingly rapid advances in technology. Public television seeks
level funding of $20 million for interconnection in FY 2022.
ready to learn: $30 million (department of education)
The U.S. Department of Education's Ready To Learn (RTL) competitive
grant program, reauthorized in the Every Student Succeeds Act, uses the
power of public television's on-air, online, mobile, and on-the-ground
educational content to build the literacy and STEM skills of children
between the ages of two and eight, especially those from low-income
families.
Through their RTL grant, CPB and PBS deliver evidence-based,
innovative, high-quality transmedia content to improve the math and
literacy skills of high-need children. CPB, PBS, and local stations
have ensured that the kids and families that are most in need have
access to these groundbreaking and proven effective educational
resources. In addition to children, this outreach focuses on adults who
care for kids to empower and help them understand the important role
they play in their children's educational success.
RTL investments have supported the production and academic rigor of
PBS KIDS series: Elinor Wonders Why, Peg + Cat, SuperWhy!, Martha
Speaks, Odd Squad and Molly of Denali--a curious and resourceful 10-
year-old Alaska Native girl who lives in the fictional village of Qyah,
Alaska--and other iconic programming for children.
But this investment does not solely rely on trusted, educational
children's programming. CPB, PBS, and local public television stations
employ a national-local model to reach parents, teachers, and
caregivers on-the-ground in communities to help them make the most of
these media resources locally. These include television, online and
mobile apps, digital technology, mobile learning labs and on the ground
events that provide valuable content and support to local school
districts, county non-profits, preschools, homeschools, Head Start and
other daycare centers, libraries, museums, and Boys and Girls Clubs,
among others.
Results
RTL is rigorously tested and evaluated to assess its impact on
children's learning and to ensure that the program continues to offer
children the tools they need to succeed in school. Since 2005, more
than 100 research and evaluation studies have shown RTL literacy and
math content engages children, enhances their early learning skills and
allows them to make significant academic gains, helping bridge the
achievement gap. Highlights of recent studies show that:
--Children from low-income households who were provided with RTL-
funded Molly of Denali videos, digital games, and activities
were better able to solve problems using informational text, -
oral, written, or visual text designed to inform--a fundamental
part of literacy that paves the way for future learning,
particularly in social studies and the sciences. After only
nine weeks of access, this impact is equivalent to the
difference in reading skills a first-grader typically develops
over three months.\1\
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\1\ Kennedy, J. L., Christensen, C., Maxon, T., Gerard, S., Garcia,
E., Hupert, N., Vahey, P., & Pasnik, S. (2021).
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--Ready To Learn-funded resources from the PBS KIDS series The Cat in
the Hat Knows a Lot About That! increased science learning in
children from low-income households and had a positive impact
on children's understanding of core physical science concepts
of matter and forces-equivalent to the difference in science
knowledge an early elementary student develops over five
months.\2\
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\2\ (Grindal, T., Silander, M., Gerard, S., Maxon, T., Garcia, E.,
Hupert, N., Vahey, P., Pasnik, S. (2019). Early Science and
Engineering: The Impact of The Cat in the Hat Knows a Lot About That!
on Learning. New York, NY, & Menlo Park, CA: Education Development
Center, Inc., & SRI International.)
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An Excellent Investment
In addition to being research-based and teacher tested, RTL also
provides excellent value for our federal dollars. In the last five-year
grant round, public broadcasting leveraged an additional $50 million in
non-federal funding to augment the $73 million investment by the
Department of Education. RTL exemplifies how the public-private
partnership that is public broadcasting can change lives for the
better.
A funding level of $30 million is requested in FY 2022 to support
current grantees and further enhance the discoverability and impact of
Ready To Learn created content and the quantity and scope of local
station outreach to the kids, families, teachers and schools that need
it the most.
Given the rigorous, thoughtful educational research and evaluation
that goes into the creation of Ready To Learn content, Ready To Learn
grants are awarded every five years and supported through annual
appropriations. Funding in FY 2022 would provide the third year of
funding in the latest grant round. Providing $30 million for Ready To
Learn in FY 2022 will ensure that CPB, PBS and stations can continue to
create the highest quality, proven-effective kids educational media,
meeting kids, caregivers and teachers where they are on a variety of
platforms, while expanding local, on-the-ground outreach through local
partners.
conclusion
Americans across the political spectrum rely on and support federal
funding for public broadcasting because we provide essential local
education, public safety, and civic leadership services that are not
available anywhere else. And none of this would be possible without the
federal investment in public broadcasting.
Federal funding is the great equalizer that ensures that the best
of public broadcasting is available in both the urban centers of our
great cities and in Native American communities in America's heartland
and everywhere in between.
Federal funding for CPB is what ensures that young children in
Appalachia have the same access to the unparalleled PBS KIDS content as
their counterparts in Los Angeles. And federal funding is what ensures
that all households, regardless of their ability to pay for cable or
streaming subscriptions have access to local programming and the best
of NOVA, Masterpiece, NewsHour, Great Performances, and so much more.
Public broadcasters are the only broadcasters that reach nearly 97%
of U.S. households, and it is CPB funding that makes this possible.
For all of these reasons we request that Congress continue its
commitment to the highly successful, hugely popular public-private
partnership that is public broadcasting by providing $565 million in FY
2024 for CPB in addition to $20 million in FY 2022 for public
broadcasting's interconnection system and $30 million in FY 2022 for
the Ready To Learn Program.
______
Prepared Statement of the National Public Radio
Chairwoman Murray, Ranking Member Blunt and Members of the
Subcommittee,
Thank you for this opportunity to urge the Subcommittee's support
for a robust annual federal investment of $565 million in FY 2024 in
public broadcasting through the Corporation for Public Broadcasting
(CPB) and $20 million in FY 2022 to continue upgrading the public
broadcasting interconnection system and other technologies and services
that create system efficiencies.
As the President and CEO of National Public Radio (NPR), I offer
this statement on behalf of the public radio system, a nonprofit public
service media enterprise that includes NPR, more than 1,000 public
radio stations, other producers and distributors of public radio
programming, and many stations, large and small, that create and
distribute content through the Public Radio Satellite System(r)
(PRSS(r)). Every day, public radio connects with millions of Americans
on the air, online, through smart speakers and mobile devices, and in
person to explore current news, music, enduring ideas, and what it
means to be human. About 98.5% of the U.S. population is within the
broadcast listening area of one or more public radio stations.
Federal funding provided by Congress to the CPB enables local,
noncommercial radio stations to provide news, information, and cultural
programming to meet the needs of local communities and offer diverse
perspectives. This funding is the bedrock of the public broadcasting
system. On average, for every $1 in federal grant money that a public
radio station receives, it raises $10 locally from audiences and local
sponsors. Public radio stations are locally owned and managed, and
thereby accountable to the local leaders and listeners they serve.
Many newspapers have lost circulation and advertisers, and are
closing their doors, eliminating sources of local news. More than 3,100
journalists at local public radio stations help to fill this need--
bringing trusted, reliable, independent news and information of the
highest editorial standards to keep communities connected. On May 6,
2021, the Radio Television Digital News Association recognized this
quality journalism by awarding public radio 277 Regional Edward R.
Murrow Awards--80 percent of the 343 awards in U.S. radio categories.
Continued investments in newsgathering capacities at public radio
stations will help ensure that public media can continue to fill the
gap for news and information in America's communities with expanded
local and regional coverage and digital services. CPB is helping to
fund public radio collaboration across key regions. In 2019, NPR and
public radio stations in Texas joined together to launch the first
regional reporting hub. In 2020, NPR and local stations launched a Gulf
states hub covering Mississippi, Alabama, and Louisiana--one of the
most news deprived regions in the country--as well as hubs in
California and the Midwest. Another NPR collaboration funded by CPB--
the Stations Investigations Team-supports local stations' investigative
journalism, helping with technical skills such as data collection and
analysis, as well as training. These collaborative arrangements allow
stations to utilize resources more efficiently, increase the scope of
regional coverage, and promote journalistic skills and mentoring.
Public radio stations play an important role in civics--supporting
state house coverage, reporting on local elections, and fostering
dialogue among communities. On a broader scale, public radio seeks to
connect Americans, including students, through coverage of national
civics issues and questions. For example, with CPB support, New
Hampshire Public Radio produces Civics 101: A Podcast, exploring topics
such as types of civic action, electoral processes, fundamental rights,
landmark Supreme Court cases, and key documents, such as the Magna
Carta. NHPR also provides resources for educators, including teacher
created lesson plans, to use these audio resources in the classroom. By
inspiring audiences of all ages to engage with foundational civics
topics, public radio can support the search for common ground across
the political spectrum.
Throughout the COVID-19 pandemic, public radio stations have
provided life-saving information and documented stories of how the
pandemic affected communities across the nation. In May 2020, a
collaborative reporting project from NPR and The Texas Newsroom found
that COVID-19 testing sites in four major cities in Texas were located
in predominately white neighborhoods, and through the examination of
available testing data, revealed that it was harder for people of color
to find test sites near where they lived. Following this exclusive
report, Dallas County opened two walk-up testing sites in Southern
Dallas, and Governor Greg Abbot announced that the state would bring
more testing to underserved communities. In 2021, NPR and reporters
from The Texas Newsroom and The Gulf States Newsroom teamed up to
examine the availability of COVID-19 vaccination sites, again
identifying disparities in the location of vaccination sites in major
cities in the Southern United States.
At the beginning of the pandemic, as listeners transitioned to
working and living in quarantine, public radio's digital audiences grew
250 percent. Audiences sought insight into the nation's response to the
coronavirus and how their local communities were affected. Public radio
stations provided live blogs on the coronavirus, explanations of public
health orders, and information on the development and distribution of
vaccines. By the end of 2020, public radio station websites
demonstrated continued audience growth, showing a 31 percent year-over-
year growth in average monthly users and a 67 percent increase in
monthly newsletter traffic.
Madam Chairwoman, Ranking Member, and members of the subcommittee,
I would be remiss if I did not thank you for the support you provided
to public radio, and the entire public broadcasting system, through the
Coronavirus Aid, Relief, and Economic Security (``CARES'') Act in 2020
and the American Rescue Plan Act earlier this year. Your support during
this crisis ensured that local public radio stations received needed
resources to maintain essential programming and services for the
communities that depended upon them.
We have seen that the COVID-19 pandemic further demonstrated the
value of public radio embracing the challenges of a multi-platform
media marketplace, while continuing to hold a dominant position in
traditional radio broadcasting. Public radio stations offer original
content through a variety of platforms and channels to reach new
audiences, including terrestrial radio, satellite radio, the web
(desktop and mobile), smart speakers, and podcasts--and application-
driven mobile services on iOS and Android (both phone and tablet) and
via aggregators such as Apple Music, Facebook News, Stitcher, and
TuneIn. The strength of this multi-platform approach is that public
radio can reach listeners wherever they are and attract new and diverse
listeners. For example, Southern California Public Radio--with CPB
support--is reaching out to younger, Latino audiences by producing
innovative, on-demand content and increasing the diversity of its on-
air hosts, producers and production staff. NPR has also partnered with
classrooms across the country in the annual Student Podcast Challenge,
which invites middle school and high school students to work with their
teachers to develop and produce a podcast for the opportunity to be
featured on NPR; a similar challenge is available for college students.
Thousands of students and teachers have participated across all 50
states, utilizing resources designed to support the process in the
classroom, develop journalism and broadcast skills, and connect public
radio to youth audiences.
Public radio is more than journalism. Stations offer communities
access to innovative music, arts, entertainment, and other cultural
programming. Public radio music-format stations play a key role in
supporting noncommercial music in the United States, playing a broad
collection of sounds and styles including jazz, blues, classical, folk,
alternative, bluegrass, zydeco, roots, and other eclectic genres.
Public radio stations make this wide variety of music accessible to
listeners through traditional broadcasts, streaming, live performances,
and music journalism. This programming supports discovery and
creativity, and connects local and national audiences to a broader
cultural conversation thus enriching both hearts and minds. Funding for
CPB plays a key role in enabling stations and program producers to
provide these cultural opportunities.
Public radio would not be possible without the federal funding
provided for the PRSS--the satellite content distribution system on
which the public radio system--including almost all stations, networks,
and producers--generally depends. The federal appropriation would allow
the current satellite-and-internet delivery system to continue to be
modernized and maintained with next-generation equipment and software.
The PRSS is open to all public telecommunications entities,
including independent producers; program syndicators and distributors;
national, state, and local organizations; and public radio stations.
Stations that receive programming distributed by the PRSS range from
those located in remote villages in northern Alaska and on Native
American reservations in the Southwest, to major market stations such
as WNYC in New York City and KUSC in Los Angeles. Through almost 400
downlinks, PRSS transmits programs distributed from NPR, other major
content producers, and more than 100 independent radio producers and
organizations with a variety of formats that include news, public
affairs, documentaries, classical music, and jazz.
CPB's support of interconnection for the PRSS facilitates the cost-
effective and efficient distribution of high-quality, educational
programming to this country's increasingly diverse population. As part
of that mission, the PRSS provides free, or ``in kind,'' satellite
transmission services to distribute programming to un-served or under-
served audiences. Currently, full-time support is given to three
program service groups: Native Voice One serving Native American
listeners; Satelite Radio Bilingue, a Spanish-language service; and the
African American Public Radio Consortium.
The PRSS also plays a vital role in the nation's emergency alert
system by receiving Presidential alerts (also called Emergency Action
Notification (EAN) alerts) fed directly from FEMA, which it can
transmit to public radio stations in the event of a nationwide crisis.
In addition, the PRSS MetaPub service enables local public radio
stations equipped with this technology to issue emergency text and
graphic alerts--such as tornado and hurricane warnings, evacuation
routes, and COVID-19 information--that are visible on screens and
synched with over-the-air broadcasts to mobile phones, HD radios,
``connected car'' smart dashboards, Radio Data System displays, and via
online audio streaming. To date, about 10 percent of interconnected
public radio stations have the capability to issue live text alerts
using the MetaPub system in the event of a natural or humanmade
disaster, such as a chemical spill.
In closing, public radio provides an essential public service for
local communities across the nation--embracing their diversity, telling
their stories, and keeping them informed with trustworthy, independent
news, information, and public safety alerts upon which they rely. Your
support for the CPB appropriation will ensure that public media can
continue to provide these critical services and be positioned to
embrace the future of the media landscape. Thank you for your support
of the public broadcasting system.
[This statement was submitted by John F. Lansing, President and
CEO, National Public Radio.]
NONDEPARTMENTAL WITNESSES
Prepared Statement of the Academy for Radiology & Biomedical
Imaging Research
Madam Chair and members of the Subcommittee, I am Mitchell Schnall,
President of the Academy for Radiology & Biomedical Imaging Research
(Academy), and the Eugene P. Pendergrass Professor of Radiology and
Chair of the Radiology Department at the Perelman School of Medicine at
the University of Pennsylvania. The Academy is more than 200 academic
research departments, patient advocacy groups, industry partners, and
imaging societies that represents thousands of radiologists and
researchers in all 50 states. The Academy is the only advocacy
organization representing the broad spectrum of the imaging research
community by collectively advocating for robust and consistent federal
research funding.\1\ It is my pleasure to submit this testimony on
behalf of the Academy. We strongly support the President's request of
$52 billion for the National Institutes of Health and ask that no less
than $46.111 billion of that be for the NIH's base program budget for
FY2022. Investigator-initiated research continues to be the foundation
of basic science and discovery. The latter figure represents an
increase of $3.177 billion over the FY2021 enacted levels. Moreover,
the Academy supports a proportional increase to the National Institute
of Biomedical Imaging and Bioengineering (NIBIB), resulting in at least
$441.1 million for FY2022--a $30.4 million increase over FY2021. These
base increases reflect approximately 5% above the biomedical research
and development price index (BRDPI). Through consistent, strong funding
for NIH and our national research infrastructure we can continue to
make advancements that will improve the lives of patients with a wide
spectrum of diseases and disorders. The Academy is grateful for the
Subcommittee's past support of NIH and encourages you to continue
advancing biomedical research and radiology and imaging science.
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\1\ https://www.acadrad.org/about-the-academy/.
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Imaging is not limited to any one disease or condition. Instead, it
serves as a necessary diagnostic tool that researchers and clinicians
of all types use to help advance our understanding of biological
systems and how best to develop and deliver treatments benefitting
patients. By improving our imaging tools and techniques, we broaden the
resources available to address many challenging conditions. In my own
work as a clinician-scientist, I use state-of-the-art technologies like
specialized magnetic resonance imaging (MRI) and 3-dimensional
mammography (digital breast tomosynthesis) to improve the diagnosis and
treatment of cancer types, including breast, prostate, and pancreatic,
while also researching rare and orphan diseases.
Imaging Innovation to Help Patients
Imaging tools can apply to a wide range of diseases and disorders
and can have very real impacts on patient outcomes. This results from
Congress's sustained federal investment in biomedical research at NIH
over the last several years. Over time, basic science advancements
translate into a variety of clinical settings, ultimately benefitting
patients. This Subcommittee's continued support of NIH, and
specifically NIBIB and the other Institutes and Centers that support
imaging research, will help generate future breakthroughs across many
biomedical challenges. Moreover, these innovations can be translated
into the commercial products, supporting the biotechnology industry and
jobs. Below are examples of the community's response to the COVID-19
pandemic, advances in detecting and treating cancer, and the role of
imaging in detecting and treating neurodegenerative diseases.
Medical Imaging and Data Resource Center: Merging Diagnostics and
Machine Learning
In the first of a two-year effort launched in 2020, the goal of the
Medical Imaging and Data Resource Center (MIDRC) is ``to foster machine
learning innovation through data sharing for rapid and flexible
collection, analysis, and dissemination of imaging and associated
clinical data...in the fight against COVID-19.'' \2\ MIDRC is an NIBIB-
funded collaboration between the American College of Radiology (ACR),
the Radiological Society of North America (RSNA), the American
Association of Physicists in Medicine (AAPM), and the University of
Chicago. These partners are building an accessible and shareable
database that can be used to accelerate clinical diagnosis, monitoring,
and treatment of COVID-19. Datasets are now being released for public
use. Moreover, MIDRC is developing machine learning tools for
evaluating medical images to determine the likelihood and future
severity of infection, as well as the prognosis for recovery. While
currently focused on Covid-19, the methods can be applied to any large
set of biomedical images to analyze and identify the likelihood of
disease or disorder. Leveraging these innovations and computational
tools augments human evaluation. This technology, using nationwide
data, also improves predictive tools for identifying serious conditions
and recovery prognoses while serving as an ``early warning'' system for
future outbreaks.
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\2\ https://www.midrc.org/.
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Combining Diagnostics and Therapy to Treat Cancer
Recent technological advances in imaging have transformed the
landscape for detecting and treating many types of cancer. Today,
diagnostics and therapeutics can be combined into one action. The
evolving field of theranostics--therapy-diagnostics--uses imaging
agents, called radiotracers, to simultaneously diagnose and deliver
therapy to affected cells. These targeted molecules are engineered to
seek out specific types of cancer cells, which may be part of primary
tumors or circulating throughout the body as metastases. Imaging for
prostate cancer is now 100 times more effective than it was only 15
years ago. And now, these same agents can be loaded with radioisotopes
designed to kill cells, becoming ``smart bombs'' aimed at cancer.
Extensive work is underway to develop smart radiotherapy agents for
numerous cancers including prostate cancer. Other targeted agents
recently approved by the FDA can simultaneously seek out and destroy
neuroendocrine cancer cells, a form of pancreatic cancer. These
advances are helping physicians become much more effective in
diagnosing and treating these and many other types of cancer, including
lymphoma and thyroid cancer. Consequently, the patient receives very
real benefits--the ability to find and treat cancer in a single action
rather than requiring repeated visits, evaluations, and more invasive
procedures. Theranostics, built on research funded by multiple
institutes at NIH, has the potential to further advance society's goal
of making cancer a treatable disease across a broad array of tumor
types.
Detecting Neurodegeneration to Manage Treatments
Every American knows at least one family with a member afflicted by
a neurodegenerative condition such as Alzheimer's disease or another
form of dementia. The inexact and sometimes subtle symptoms of these
conditions in their early stages, combined with the challenges of
studying a living human brain, can make effective diagnoses
challenging. Recent breakthroughs in imaging provide alternative, more
precise tools physicians can use to diagnose and manage the care of
affected patients. New imaging agents allow investigators to detect and
quantify amyloid plaques and Tau proteins in the brains of patients--
two leading indicators for Alzheimer's disease. This ability informs
and accelerates the search for new treatments and methods to predict
which patients may benefit from such therapies. In fact, a recent
clinical trial investigated a new treatment for the removal of amyloid
plaque from patients, an approach enabled by an approved imaging agent
supported by an NIH grant.
Treatment of another neurological condition, Parkinson's disease,
has also advanced because of emerging imaging research. Patients
suffering from essential tremor symptoms, including those with
Parkinson's, can now benefit from therapies in which magnetic resonance
imaging (MRI) images are used to direct sound waves--High-intensity
Focused Ultrasound--in a non-invasive way to alter neuronal connections
and activities. This intervention often leads to instantaneous
improvement in patient symptoms. While not a cure, alleviation of
tremor symptoms allows patients to continue managing their condition by
caring for themselves through actions such as dressing, eating, and
other activities that require fine motor skills.
summary and conclusion
Sustained and robust NIH funding is crucial to advancing our
efforts to understand and ultimately treat a myriad of diseases and
disorders across human systems. NIH investments are also a key economic
driver at local research institutions, and NIH funds flow to every
state in the nation.\3\ If we are to remain a global leader in
biomedical research and innovation, continued, strong support for NIH
is essential. Funding NIH's base program with at least $46.111 billion
will provide the robust support needed to sustain growth for biomedical
research.
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\3\ https://www.unitedformedicalresearch.org/wp-content/uploads/
2021/03/NIHs-Role-in-Sustaining-the-U.S.-Economy-FINAL-3.23.21.pdf.
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Thank you for your strong, continued support of NIH, NIBIB, and all
the Institutes and Centers working to advance our biomedical research
efforts and to improve the lives of patients worldwide. On behalf of
the Academy, I urge you to continue your strong support of our nation's
research and innovation enterprise.
[This statement was submitted by Mitchell Schnall, M.D., Ph.D.,
President,
Academy for Radiology & Biomedical Imaging Research.]
______
Prepared Statement of the Academy of Nutrition and Dietetics
Dear Chair Murray and Ranking Member Blunt,
The Academy of Nutrition and Dietetics appreciates the opportunity
to submit testimony to the subcommittee for FY22 appropriations.
Representing more than 112,000 credentialed nutrition and dietetics
practitioners, the Academy is the world's largest organization of food
and nutrition professionals and is committed to improving the nation's
health with nutrition services and interventions provided by registered
dietitian nutritionists.
For FY22, we strongly urge you to provide funding for the promotion
of the 2020-2025 Dietary Guidelines for Americans by the HHS Office of
Disease Prevention and Health Promotion; the CDC Division of Nutrition,
Physical Activity, and Obesity; and for Americans Older Americans Act
senior nutrition programs. In the Department of Education, we support
the Health Professionals of the Future program proposed in the
President's budget.
Funding: DGA Promotion by the HHS Office of Disease Prevention and
Health Promotion--FY2022 Request: $3 million
The 2020-2025 Dietary Guidelines for Americans were released in
December 2020 and featured new nutrition recommendations for children
from birth through 24 months and pregnant and lactating women. For the
Dietary Guidelines for Americans to achieve their intended reach and
impact, it is essential that the federal government invest in educating
consumers and health care professionals on these new guidelines.
The HHS Office of Disease Prevention and Health Promotion (ODPHP)
and the USDA Center for Nutrition Policy and Promotion (CNPP) and they
should jointly work to develop materials for comprehensive education
campaigns aimed at: (1) educating consumers on how to use the new
Dietary Guidelines to inform their dietary choices; and (2) health care
professionals to align their dietary guidance with the new Guidelines.
The campaign should be informed by scientific research on health
behavior change, as well as input from key stakeholder groups,
including nutrition assistance program participants and administrators,
health care providers, community leaders, and health and nutrition
advocates. The campaign should incorporate educational materials
representing wide diversity of cultural food preferences and should be
available in languages that meet the needs of populations at risk for
diet-related disease.
Funding: Older Americans Act Nutrition Programs (HHS ACL)
The Older Americans Act authorizes a wide array of service programs
that are overseen by the HHS Administration for Community Living and
delivered through a national network of state agencies, area agencies
on aging, and nearly 20,000 service providers.\1\ Most program
participants have household incomes below 100% of the federal poverty
level.\2\ In addition to directly combatting senior hunger during this
time of uncertainty, senior meals programs have also reduced the need
for seniors to leave their homes to get food, helping to limit their
exposure to COVID-19. A significant increase in funding for these
programs would not only allow more seniors to be served but would free
up money for the nutrition assessment and educational components of
these programs that are often sacrificed in order to reduce wait lists
for meals.
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\1\ https://acl.gov/about-acl/authorizing-statutes/older-americans-
act.
\2\ https://fas.org/sgp/crs/misc/IF10633.pdf.
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Congregate Nutrition Services
Congregate Nutrition Services funds nearly 80 million meals per
year for 1.5 million participants and gives seniors access to
socialization. More than one-fifth of participants have been deemed to
be at high nutrition risk. These funds are also used to provide
nutrition screening and counseling to seniors who may be at risk of
malnutrition, food insecurity or other issues. For the duration of the
COVID-19 public health emergency, service agencies have been given the
flexibility to convert their congregate meals programs into drive-up or
grab-and-go programs and to use any surplus funds from their congregate
nutrition services budget to provide home-delivered meals.
Home-Delivered Nutrition Services
Home-Delivered Nutrition Services provides more than 145 million
meals per year to 867,000 participants, with more than half of program
participants categorized as being at high nutrition risk.\3\ The
program also serves as a welfare check for isolated seniors and as a
primary access point for other home- and community-based services. The
demand for this crucial nutrition security program has been
unprecedented during the COVID-19 pandemic.
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\3\ https://www.cdc.gov/nccdphp/dnpao/state-local-programs/
funding.html.
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Funding: CDC Division of Nutrition, Physical Activity, and Obesity--
Division of Nutrition, Physical Activity and Obesity--FY2022
Request: $125 million
The CDC Division of Nutrition, Physical Activity, and Obesity
(DNPAO) oversees grant programs that provide funds to states and
localities to address the obesity epidemic in their communities.\3\
Adult obesity prevalence is at over 42% in 2017-2018.\4\ Obesity-
related conditions include heart disease, stroke, type 2 diabetes and
certain types of cancer that are some of the leading causes of
preventable, premature death. In 2008, the annual medical cost of
obesity in the United States was estimated to be $147 billion; the
medical cost for people who have obesity was $1,429 higher than those
of normal weight. Having obesity is a top risk factor for severe
disease, hospitalization and death from COVID-19. Minority and low-
income communities often lack access to healthful foods and safe places
to be active, and these inequities contribute to obesity and other
chronic disease disparities that are contributing to disproportionate
COVID-19 morbidity and mortality.
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\4\ https://www.cdc.gov/obesity/data/adult.html.
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State Physical Activity and Nutrition Program--FY2022 Request: $60
million
The State Physical Activity and Nutrition (SPAN) grant program at
DNPAO awards competitive grants to states to implement multi-component,
evidence-based strategies at the state and local level to improve
nutrition and physical activity.\5\ With its current funding level,
SPAN is only able to fund 16 states, which is does via five-year grants
(currently FY18-22). DNPAO estimates that it would cost an additional
$1.2 million per state to expand the program, so we are requesting $60
million of the $125 million for DNPAO to go to SPAN to allow every
state to receive SPAN grant funding.
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\5\ https://www.cdc.gov/nccdphp/dnpao/state-local-programs/span-
1807/index.html.
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Funding: Health Professionals of the Future (ED)--FY2022 Request: $200
million
COVID-19's disproportionate impact on communities of color has made
the need for health professional workforce diversity and culturally
competent care more urgent than ever. Historically Black Colleges and
Universities (HBCUs), Tribal Colleges and Universities (TCUs), and
other Minority Serving Institutions (MSIs) have long been leaders in
addressing health equity in America. Specifically, HBCUs graduate 43%
of all African Americans with postsecondary degrees in STEM fields and
roughly 15% of all African American physicians. Despite these
successes, gaps remain, particularly among registered dietitian
nutritionists.
The Health Professionals of the Future proposal \6\ put forth in
the FY22 President's budget would help close these gaps by creating and
funding a competitive grant program that provides funding to MSIs to
create or expand graduate programs that prepare students for high-
skilled jobs in the health care sector and help diversify the
healthcare sector pipeline. Authorized activities would include the
development of a career and educational pathways exploratory system to
assist undergraduate and graduate students in learning about career
opportunities in these fields and connecting students to internships
and jobs; support services to help students complete graduate programs;
scholarships or fellowships for tuition or to support on-the-job
training.
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\6\ https://www2.ed.gov/about/overview/budget/budget22/
justifications/t-highered.pdf#page=147.
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Contact
Please feel free to contact me at [email protected] with any
questions on these important issues. Thank you for the opportunity to
submit our recommendations to the subcommittee.
Sincerely.
[This statement was submitted by Hannah Martin, MPH, RDN, Director,
Legislative and Government Affairs, Academy of Nutrition and
Dietetics.]
______
Prepared Statement of the Ad Hoc Group for Medical Research
The Ad Hoc Group for Medical Research is a coalition of nearly 400
patient and voluntary health groups, medical and scientific societies,
academic and research organizations, and industry. We appreciate the
opportunity to submit this statement in support of strengthening the
federal investment in biomedical, behavioral, social, and population-
based research conducted and supported by the National Institutes of
Health (NIH) through a recommendation of at least $46.1 billion for
NIH's base program level budget in FY 2022.
As a result of the strong, bipartisan vision of the House and
Senate Labor-HHS-Education Subcommittees over the last six years,
Congress has helped the agency regain some of the ground lost after
years of effectively flat budgets. That renewed investment in NIH has
advanced discovery toward promising therapies and diagnostics,
reenergized existing and aspiring scientists nationwide, and restored
hope for patients and their families. As the Subcommittee has
recognized, to remain a global leader in accelerating the development
of life-changing cures, pioneering treatments, and innovative
prevention strategies, and in this time of unprecedented scientific
opportunity, it is essential that Congress sustain long-term robust
increases in the NIH budget.
In FY 2022, the Ad Hoc Group for Medical Research supports at least
$46.1 billion for the NIH base program level budget, including funds
provided through the 21st Century Cures Act Innovation Fund for
targeted initiatives, a $3.2 billion increase over the NIH's program
level funding in FY 2021. This funding level, supported by nearly 400
stakeholder organizations, would provide 5% growth in the base budget
above inflation, expanding NIH's capacity to support promising science
in all disciplines. We are grateful for President Biden's enthusiasm
for medical research investments and welcome opportunities to engage
with the Congress and the Administration regarding the proposed
Advanced Research Projects Agency for Health (ARPA-H). Robust growth in
the foundational research that NIH supports will be key to this vision,
and we urge lawmakers to ensure no less than $46.1 billion for the
NIH's base and that any additional funds for ARPA-H or other targeted
initiatives supplement, rather than supplant, this core investment.
We further recommend a funding allocation for the Labor-HHS-
Education Subcommittee in FY 2022 that allows for the necessary
investment in NIH and other agencies that promote the health of our
nation. We believe that science and innovation are essential if we are
to continue to meet current and emerging health challenges, improve our
nation's physical and fiscal health, and sustain our leadership in
medical research.
In addition, we remain concerned about the lingering $16 billion
impact of the coronavirus pandemic on medical research progress in all
disease areas, and especially on the research workforce, as highlighted
by NIH Director Dr. Francis Collins' recent testimony before this
Subcommittee. The supplemental funding Congress has provided over the
last year has been instrumental in advancing research on COVID-19, with
tremendous success in the form of multiple safe and effective vaccines
to combat SARS-CoV-2 and other advances. But the pandemic has
threatened progress across numerous other areas, with particular
challenges for women, minorities, and early career investigators in the
research workforce. We continue to urge support for emergency
resources, as outlined in the RISE Act (H.R. 869/S. 289), that will
allow the NIH to rebuild the nation's strong and diverse research
workforce infrastructure and continue to invest in broad and new
research areas that will provide better health for patients in the
future.
NIH: A Partnership to Save Lives and Provide Hope. The partnership
between NIH and America's scientists, medical schools, teaching
hospitals, universities, and research institutions is a unique and
highly productive relationship, leveraging the full strength of our
nation's research enterprise to translate this knowledge into the next
generation of diagnostics, therapeutics, and cures. More than 80
percent of the NIH's budget is competitively awarded through nearly
50,000 research and training grants to more than 300,000 researchers at
over 2,500 universities and research institutions located in every
state and Washington, D.C. The federal government has an essential and
irreplaceable role in supporting medical research. No other public,
corporate or charitable entity is willing or able to provide the broad
and sustained funding for the cutting-edge basic research necessary to
yield new innovations and technologies of the future.
NIH has supported biomedical research to enhance health, lengthen
life, respond to emerging health threats, and reduce illness and
disability for more than 100 years. For patients and their families,
NIH is the ``National Institutes of Hope.'' The following are a few of
the many examples of how NIH research has contributed to improvements
in the nation's health.
--NIH-funded basic research laid the groundwork for the novel mRNA
vaccine technology used in the first two FDA approved SARS-CoV-
2 vaccines. Vaccines continue to be one of our most cost-
effective public health tools with every $1 spent on routine
childhood vaccinations estimated to save $5 in direct costs,
and $11 in broader costs to society.
--Following nearly three decades of NIH-funded research into novel
mechanisms of drug action, breakthroughs in the treatment of
depression came in 2019 with two new FDA-approved drugs--one
for treatment-resistant depression and the first ever treatment
for postpartum depression.
--In 2007, induced pluripotent stem cells (iPSC) were discovered when
adult cells were re-engineered into early non-differentiated
versions of themselves. In 2019, the National Eye Institute
launched a first-in-human clinical trial to test the safety of
a novel patient-specific iPSC therapy to treat the most common
form of Age-related Macular Degeneration, and the leading cause
of vision loss in the age 65+ population.
--NIH-supported researchers continue to work toward strategies to
better prevent, identify, and treat pain and substance use
disorders through the HEAL (Helping to End Addiction Long-term)
Initiative. HEAL aims to support research into new, non-
addictive medication and to establish public and private
partnerships to develop best practices in communities.
--Today, treatments can suppress HIV to undetectable levels, and a
20-year-old HIV-positive adult living in the U.S. who receives
these treatments is expected to live into his or her early 70s,
nearly as long as someone without HIV.
--The death rate for all cancers combined has declined in adults
since the early 1990s and since the 1970s for children. Overall
cancer death rates have dropped by 29% including a 2.2% drop
from 2016 to 2017, the largest single-year drop in cancer
mortality ever reported.
Sustaining Scientific Momentum Requires Sustained Funding Growth.
The leadership and staff at NIH and its Institutes and Centers have
engaged the broader community to identify emerging research
opportunities and urgent health needs and to prioritize precious
federal dollars to areas demonstrating the greatest promise. Sustained
robust increases in NIH funding are needed if we are to continue to
take full advantage of these opportunities to accelerate the
development of pioneering treatments and innovative prevention
strategies.
One long-lasting potential impact of investments in NIH is on the
next generation of scientists. Sustained increases in NIH funding over
the last six years have allowed NIH to more than double the investment
in early stage investigators (ESIs). In 2015, NIH only funded about 600
grants for ESIs and the career outlook for early career researchers
seemed grim. In FY 2020, NIH was able to fund more than 1,400 grants
for ESIs, reinvigorating the spirits of researchers in the biomedical
workforce. Sustained increases are needed to allow NIH to continue
support of new talent and innovation in medical research.
Even with recent investments in NIH, nearly 4 of every 5 research
ideas that are proposed to NIH every year cannot be funded. Additional
funding is needed if we are to strengthen our nation's research
capacity, ensure a medical research workforce that reflects the racial
and gender diversity of our citizenry, and inspire a passion for
science in current and future generations of researchers.
NIH is Critical to U.S. Competitiveness. Our country still has the
most robust medical research capacity in the world; however, other
countries have significantly increased their investment in biomedical
science, which leaves us vulnerable to the risk that talented medical
researchers from all over the world may return to better opportunities
in their home countries. We cannot afford to lose that intellectual
capacity, much less the jobs and industries fueled by medical research.
The U.S. has been the global leader in medical research because of
Congress's bipartisan recognition of NIH's critical role. To continue
our dominance, we must reaffirm this commitment to provide NIH the
funds needed to maintain our competitive edge.
NIH: An Answer to Challenging Times. Research supported by NIH
drives local and national economic activity, creating skilled, high-
paying jobs and fostering new products and industries, and catalyzes
increases in private sector investment. A $1 increase in public basic
research stimulates an additional $8.38 investment from the private
sector after eight years. A $1 increase in public clinical research
stimulates an additional $2.35 in private sector investments after
three years. According to a United for Medical Research report, in FY
2020, NIH-funded research supported more than 536,000 jobs across the
U.S. and generated more than $91 billion in economic activity.
The Ad Hoc Group's members recognize the tremendous challenges
facing our nation and acknowledge the difficult decisions that must be
made to restore our country's fiscal health. Robust funding of the NIH,
and strengthening our commitment to medical research, is a critical
element in ensuring the health and well-being of the American people
and our economy. Therefore, for FY 2022, the Ad Hoc Group for Medical
Research recommends that NIH receive at least $46.1 billion in base
funding to advance the foundational research NIH supports and continue
the momentum in our nation's investment in medical research.
______
Prepared Statement of The AIDS Institute
Dear Chairwoman Murray and Members of the Subcommittee:
The AIDS Institute, a national public policy, research, advocacy,
and education organization, is pleased to offer testimony in support of
domestic HIV and hepatitis programs in the FY2022 Labor, Health and
Human Services, Education, and Related Agencies (L-HHS) appropriation
measure. This year's L-HHS bill is more important than ever, as it will
set up critical funding streams to help rebuild and reinvest in our
nation's public health infrastructure, which has been decimated by
COVID-19. As you craft the FY2022 L-HHS appropriations bill, we urge
you to significantly increase funding for the Ending the HIV Epidemic
Initiative, as well as appropriate additional funds for core public
health programs that work to treat and prevent HIV and viral hepatitis
in the United States. These programs, many of which are a part of the
safety net health system, will be key tools in recovering from COVID-
19, and ensuring those most impacted by the COVID pandemic's economic
fallout can still access critical care.
hiv in the united states
Approximately 1.2 million people are living with HIV in the U.S.
Since the height of the epidemic, there have been tremendous
advancements in HIV treatment and prevention. A person living with HIV
on treatment can expect to live a near full life, and if they achieve
an undetectable viral load, are unable to pass HIV on to a partner. The
toolbox for HIV prevention is ever expanding, with pre-exposure
prophylaxis (PrEP) being the newest tool that couples with traditional
prevention techniques like condoms and syringe service programs.
Despite these advancements, new cases of HIV have been stagnant at
around 38,000 cases a year since 2013. Over the last year, COVID-19 has
severely impacted HIV prevention and treatment programs, many of which
have had to reduce services, suspend in-person testing, transition to
telehealth, and detail staff to COVID response. These programs have
been forced to innovate during COVID, and we hope some of the lessons
learned can be sustained after the pandemic has ended, such as
expansion of at-home HIV testing and increased utilization of
telemedicine for HIV treatment and PrEP expansion. It is extremely
important that additional funding goes to these programs this year so
that we can again start reducing new HIV infections while allowing
programs to refocus on core HIV prevention and treatment programs that
are vital to making progress against this epidemic.
Additionally, we believe that ending HIV is a racial justice issue.
Three quarters of new HIV infections are among people of color because
of racism and structural barriers in the healthcare system. To end HIV,
these barriers must be broken down, and we believe people living with
HIV and the communities they live in must be the drivers behind
eliminating racism in healthcare.
ending the hiv epidemic initiative
The Ending the HIV Epidemic Initiative (EHE), which began in 2019,
is focused on reducing new HIV infections by 90 percent over ten years.
In the last two years, your Committee provided $260 million and $404
million respectively for the EHE Initiative, which is run by the CDC,
the Health Resources and Services Administration (HRSA), and the
National Institutes of Health (NIH). The resources were focused on 57
jurisdictions with the greatest share of HIV incidence, enabling these
jurisdictions to craft and implement community-specific plans to reduce
the spread of HIV. HRSA's EHE funding for Community Health Centers has
already shown promising results, with more than 10,000 new clients
being treated for HIV, nearly 865,000 HIV tests administered, and
63,000 new PrEP prescriptions for people at risk for HIV. With greater
funding and continued commitment from the Biden Administration to grow
the EHE Initiative, The AIDS Institute believes this nation can make
significant progress toward the goal of ending the HIV epidemic.
We urge you to fund year three of the EHE Initiative at the
following levels: $371 million for the CDC Division of HIV/AIDS
Prevention to conduct targeted testing, connection to treatment, and
robust surveillance; $212 million for the Ryan White HIV/AIDS Program
to increase access to high-quality HIV care and treatment; $152 million
for HRSA's Community Health Center program to provide prevention
services emphasizing PrEP; $16 million for NIH's Centers for AIDS
Research to provide best practices to guide the plan; and $27 million
for the Indian Health Service to provide HIV prevention, treatment,
education, and hepatitis C (HCV) elimination in Indian Country. In
order for jurisdictions to better plan for years four through ten of
the Initiative, we urge the Committee to work with HHS, OMB and the
White House Office of HIV/AIDS Policy to make public out-year funding
projections for appropriations needed to accomplish the goals of the
Initiative by 2030.
cdc hiv prevention
CDC's Division of HIV/AIDS Prevention focuses resources on those
populations and communities most affected by investing in high-impact
prevention. One in seven people living with HIV in the United States
are unaware of their status, so it is critical that HIV testing and
prevention programs are in place to help connect people to care. There
is no single way to prevent HIV, but jurisdictions use a combination of
effective evidence-based approaches including testing, linkage to care,
education, condoms, syringe service programs, and PrEP. We urge the
Subcommittee to fund CDC's HIV Prevention program at $1.293 billion,
which includes $100 million for school-based HIV prevention efforts and
$371 million for the Ending the HIV Epidemic Plan.
the ryan white hiv/aids program
The Ryan White HIV/AIDS Program provides medications, medical care,
and essential coverage completion services to almost half of all people
living with HIV in the United States, many of whom are uninsured or
underinsured. The Ryan White Program successfully engages individuals
in care and treatment, increases access to HIV medications, and helps
over 88 percent of clients achieve viral suppression (which is critical
for HIV prevention, because people who have achieved viral suppression
cannot transmit HIV to others). Increased funding is required in FY2022
because COVID-19 has strained and will continue to strain Ryan White
programs, which have had to respond to increased demand from people
living with HIV who lost their jobs and their health insurance because
of the pandemic.
The AIDS Institute requests that the Subcommittee fund the Ryan
White HIV/AIDS Program at a total of $2.776 billion in FY2022,
distributed in the following manner: Part A at $686.7 million; Part B
(Care) at $444.7 million; Part B (ADAP) at $943.3 million; Part C at
$225.1 million; Part D at $85 million; Part F/AETC at $35.5 million;
Part F/Dental at $18 million; and Part F/SPNS at $34 million; Ending
the HIV Epidemic Plan at $212 million.
minority aids initiative
As racial and ethnic minorities in the U.S. are disproportionately
impacted by HIV/AIDS, it is critical that the Subcommittee continue to
fund the Minority HIV/AIDS Fund and Minority AIDS programs at SAMHSA.
We urge the Subcommittee to appropriate $105 million for the Minority
HIV/AIDS Fund; and $160 million for SAMHSA's Minority AIDS Initiative
Program.
viral hepatitis in the u.s
There has been significant increase in the number of new cases of
hepatitis A (HAV), hepatitis B (HBV), and hepatitis C (HCV) in the U.S.
over the past decade, despite medical advances that make preventing and
treating viral hepatitis more effective. There are highly effective
vaccines for both HAV and HBV, yet cases of HAV have increased 1,300
percent since 2015 and the number of new cases of HBV have remained
stable for the past decade. There are several curative treatments for
HCV, yet the number of new HCV cases has increased by 484 percent over
the past decade with no signs of slowing. The increased incidence of
viral hepatitis is largely due to increased injection drug use related
to the opioid epidemic. Moreover, the CDC estimates that as many as
half of the people who are living with chronic HBV and HCV (400,000 and
1.2 million people respectively) may be unaware that they have
contracted the conditions. Left untreated, viral hepatitis causes liver
damage, liver disease, cancer, and death. It also contributes to or
exacerbates other serious and chronic conditions, increasing health
care costs. We also expect to see even greater increases in viral
hepatitis cases when data become available for 2020, as we know that
many state public health systems were unable to maintain outreach,
testing, and treatment services for viral hepatitis while also battling
COVID-19, and many harm reduction programs were also unable to operate
at full capacity during the pandemic. We can eliminate viral hepatitis,
but doing so will require substantially increased investment in the
public health infrastructure for prevention, screening, and treatment.
infectious disease impact of the opioid crisis
The recent explosion of opioid use has created tremendous risk for
viral hepatitis and HIV outbreaks and increasing infection rates among
new groups and undoing progress toward curbing transmissions. The
COVID-19 pandemic has caused another surge in injection drug use, with
2020 poised to have the highest overdose death total on record. The
systems built to respond to HIV and viral hepatitis are well poised to
conduct outreach, engagement, and early intervention services with
individuals who use drugs. A comprehensive response to the opioid
epidemic must include infectious disease prevention efforts to reduce
the infectious disease consequences of the epidemic.
Starting in FY19, Congress allocated new funding to surveil,
prevent and treat infectious diseases commonly associated with
injection drug use, including viral hepatitis and HIV. We urge the
Subcommittee to appropriate $120 million for the CDC's infectious
diseases and opioid epidemic efforts.
cdc viral hepatitis prevention
The CDC's Viral Hepatitis program funding level is only $39.5
million, which is not nearly sufficient to address the increasing scope
of the epidemic. In 2016, the agency suggested it would need 10 times
that amount annually to establish a comprehensive national program to
effectively combat the spread of viral hepatitis. This year, we request
that the Subcommittee appropriate $134 million to the CDC to address
the rise in viral hepatitis and combat the impact of the opioid crisis.
syringe service programs
Syringe service programs (SSPs) are a critical tool in the fight to
end the opioid epidemic and eliminate viral hepatitis. These important
public safety programs reduce the spread of infectious disease, prevent
overdose deaths, and connect clients to treatment. The presence of SSPs
has been associated with a 50 percent decline in new HIV and viral
hepatitis incidence, and when combined with medication-assisted
treatment, there is a two-thirds reduction in HIV and HCV transmission.
Extensive research shows that these programs save money and that they
do not increase drug use. But there are not enough SSPs to meet the
growing need, and appropriations language prohibiting them from using
federal funds to purchase sterile syringes makes it difficult for many
programs to meet their biggest expense. We urge your Subcommittee to
increase funding for SSPs and to remove all restrictions on federal
funding for syringe service programs, including for the purchase of
sterile syringes. The President's FY22 Budget Request and the House's
FY21 appropriations bill both removed the restrictions for the purchase
of sterile syringes.
public health infrastructure
Decades of chronic underfunding of public health infrastructure
programs have left the United States extremely vulnerable to public
health disasters, as evidenced by the untold physical and economic harm
COVID-19 has wrought on our nation, with more than 33 million Americans
sickened and over 600,000 deaths to date. Pandemics are a threat to our
nation's safety and health, and we urge the Committee to fund public
health programs with the same priority as traditional defense programs.
Billions in increased funding is needed annually to ensure that public
health programs are modernized, fully staffed, and prepared for public
health emergencies. Yearly appropriations have fallen far short of what
is needed to protect America's health, which has allowed emerging
threats like COVID-19 to wreak havoc.
The AIDS Institute thanks Chairwoman Murray for reintroducing the
Public Health Infrastructure Saves Lives Act (S.674), which would
create the Core Public Health Infrastructure Program withing the CDC.
We believe that this program, if fully funded, will start to rebuild
and bolster critical infrastructure needed to prepare for the next
public health threat. We thank the Committee and your colleagues for
significant increases in emergency funding approved during COVID-19,
but we also urge you to ensure that this funding is sustained to
forestall future emergencies. We urge the Committee Members and your
colleagues to support S. 674, and once signed into law, ensure that the
authorized programs are fully funded by your Committee.
Thank you for your consideration of this written testimony. If you
have questions or would like to discuss these issues further, please do
not hesitate to contact Nick Armstrong at [email protected] or
Frank Hood at [email protected].
[This statement was submitted by Rachel Klein, Deputy Executive
Director, The AIDS Institute.]
______
Prepared Statement of AIDS United
Dear Chairman Leahy, and Vice Chairman Shelby:
As the committee continues its important deliberations on the
Fiscal Year (FY) 2022 Labor, Health and Human Services, Education, and
Related Agencies (Labor-HHS) appropriation bill, we thank you for your
commitment to ending the HIV/AIDS epidemic in the United States and
request that you increase the federal government's financial commitment
to meet the goals of the federal ending the epidemic initiative and
support safety net programs that protect the public health.
Our scientific knowledge of HIV treatment, prevention and
epidemiology has never been stronger, but progress, until recently, has
stalled. Over the past three years, a concerted effort to target
resources where they can be most effective has occurred through the
Ending the HIV Epidemic Initiative (EHE Initiative), which has the goal
of reducing new HIV infections by 90% by 2030. Additionally, the HIV
National Strategic Plan: A Roadmap to End the Epidemic has been
developed. We urge Congress to capitalize on the expertise developed by
communities as part of the EHE Initiative so that we can improve and
expand the Initiative. Ending HIV by 2030 is possible, but resources
are needed to achieve this goal.
The COVID-19 pandemic has shown a light on the impact of decades of
underfunding our Nation's public health infrastructure, resulting in an
inadequate response to an incredibly destructive pandemic. Below are
detailed domestic HIV funding requests that we join our coalition
partners in the Federal AIDS Policy Partnership in urging committee to
include in the FY2022 appropriations bills. A chart detailing each
request as well as previous fiscal year funding levels for each program
is available here: http://federalaidspolicy.org/fy-abac-chart/.
ending the hiv epidemic initiative
Over the last two years, on a bipartisan basis, Congress has
appropriated additional funding for the Ending the HIV Epidemic
Initiative, which sets the goal of reducing new HIV infections by 50%
by 2025, and 90% by 2030. We ask Congress to increase funding in FY2022
for the Ending the HIV Epidemic Initiative by at least the amounts
listed below in the following operating divisions:
--CDC Division of HIV/AIDS Prevention for testing, linkage to care,
and prevention services, including pre-exposure prophylaxis
(PrEP) (+$196 m);
--HRSA Ryan White HIV/AIDS Program to expand comprehensive treatment
for people living with HIV (+$107 m);
--HRSA Community Health Centers to increase clinical access to
prevention services, particularly PrEP (+$34.7 m);
--The Indian Health Service (IHS) to address the combat the disparate
impact of HIV on American Indian/Alaska Native populations
(+$22 m); and
--NIH Centers for AIDS Research to expand research on implementation
science and best practices in HIV prevention and treatment.
the ryan white hiv/aids program
The Ryan White Program provides comprehensive care to populations
disproportionately impacted by the HIV epidemic. Over three quarters of
Ryan White clients are racial and ethnic minorities, and nearly two
thirds are under the federal poverty level. With 88% of Ryan White
clients achieving viral suppression, the program has a proven track
record of success.
The Ryan White Program provides services critical to managing HIV,
often inadequately covered by insurance, including case management;
mental health and substance use services; adult dental services; and
transportation, legal, and nutritional support services. Many Ryan
White Program clients live in states that have not expanded Medicaid
and must rely on the Ryan White Program as their only source of HIV/
AIDS care and treatment. While increasingly clients have access to
insurance, patients still experience cost barriers, such as high
premiums, deductibles, and other patient cost sharing. The Ryan White
Program, particularly the AIDS Drug Assistance Program (ADAP), assists
with these costs so that clients can access comprehensive treatment.
Currently ADAPs are experiencing increased demand, particularly as
people have lost health coverage and incomes due to the economic impact
of COVID-19 and state and local budgets have been increasingly
stressed. We urge Congress to fund the Ryan White HIV/AIDS Program at a
total of $2.768 billion in FY2022, an increase of $345 million over
FY2021, distributed in the following manner:
--Part A: $731.1 million
--Part B (Care): $437 million
--Part B (ADAP): $968.3 million
--Part C: $225.1 million
--Part D: $85 million
--Part F/AETC: $58 million
--Part F/Dental: $18 million
--Part F/SPNS: $34 million
--EHE Initiative: $212 million
cdc prevention programs
CDC HIV Prevention and Surveillance
Increasing funding for high-impact, community focused HIV
prevention services has proven to result in a strong return on
investment. Not only are these prevention tools effective at halting
new HIV infections, but in the long term they result in decreased
lifetime medical costs that are associated with HIV treatment. HIV
prevention tools that meet the special prevention needs of these
populations must be expanded. HIV will not be eliminated unless we
focus resources on those most impacted.
The CDC's Division of HIV Prevention is the federal leader in
creating new and innovative strategies for HIV prevention. Through
partnerships with state and local public health departments and
community-based organizations, the CDC has expanded targeted, high-
impact prevention programs that work to address racial and geographic
health disparities. We urge you to fund the CDC Division of HIV
Prevention at $822.7 million in FY2022, an increase of $67 million over
FY2021. This is in addition to the $371 million for EHE Initiative work
within the Division.
CDC STD Prevention
Our nation faces a compounded public health crisis. STI rates are
at an all-time high for the sixth year in a row. STI data from 2018
shows that combined cases of chlamydia, gonorrhea, and syphilis
infections are nearing 2.4 million cases a year--up 30%. STIs have
life-changing and life-threatening consequences that include
infertility, cancer, ectopic pregnancy, pelvic inflammatory disease,
and transmission of HIV. More than 17 years of level funding for STI
programs has resulted in a more than 40% reduction in buying power. The
STI health infrastructure is part of the public health infrastructure
and the need to rebuild is higher than ever. While STI rates peak, the
same people who work to prevent the spread of sexually transmitted
diseases--contact tracers and disease intervention specialists--have
been redeployed to address the current COVID-19 pandemic. Consequently,
80% of sexual health screening clinics being forced to reduce hours or
shut down because of understaffing. We urge you to fund the CDC
Division of STD Prevention at $252.9 million to rebuild its
infrastructure and respond to the dramatic rise in STIs across the
country.
Congenital Syphilis is a fully preventable disease if women are
provided early, accessible prenatal care that includes STI testing.
Despite this, the transmission of congenital syphilis from mother to
child during birth increased by 185% between 2014-2018 with an increase
more than 40% between 2017 and 2018 alone. The result: a 22% increase
in newborn deaths. Twenty million dollars should be allocated to
activate a new congenital syphilis elimination initiative at the CDC
Division of STD Prevention (DSTDP)--with funds distributed to all STI-
funded health departments--to increase prenatal outreach and screenings
for congenital syphilis and postnatal follow up for both mothers and
babies to ensure that congenital syphilis is detected at the earliest
possible stage. We urge you to fund the CDC Division of STD Prevention
at $272.9 million in FY2022, an increase of $91.1 million over FY2021.
CDC Viral Hepatitis Prevention
The ongoing opioid crisis and increased injection drug has
drastically increased the number of new viral hepatitis cases in the
U.S. The CDC estimates that between 2010 and 2017 the country
experienced a 374% increase in new hepatitis C (HCV) infections, with
an estimated 44,600 new cases in 2017. The number of new cases of
hepatitis B (HBV) has also increased over the past several years, with
22,200 new cases in 2017, ending years of declining rates. Of the more
than 3.2 million people now living with HBV and/or HCV in the U.S., as
many as 65% are not aware of their infection.
The CDC's Division of Viral Hepatitis (DVH) remains the lead agency
combating viral hepatitis at the national level by providing important
information and funding to the states. The division is currently funded
at only $39.5 million. This is nowhere near the nearly $393 million CDC
estimates is needed for a national viral hepatitis program focused on
decreasing mortality and reducing the spread of the disease. We have
the tools to prevent this growing epidemic and the Viral Hepatitis
National Strategic Plan for the United States: A Roadmap to Elimination
(2021--2025). However, only with significantly increased funding can
there be an adequate level of testing, education, screening, treatment,
surveillance, and on-the-ground syringe service programs needed to
reduce new infections and put the U.S. on the path to eliminate
hepatitis as a public health threat. We urge you to fund the CDC's
Division of Viral Hepatitis at $134 million in FY2022, an increase of
$94.5 million over FY2021.
CDC Infectious Diseases and Opioid Epidemic Funding
The FY2019 budget included new funding for the CDC to combat
infectious diseases commonly associated with injection drug use in
areas most impacted by the opioid crisis. The United States is
experiencing an ongoing overdose crisis and some experts have estimated
that the U.S. surpassed 100,000 deaths from opioid overdose in 2020, a
more than 40% increase from 2019 itself a record year. Outbreaks or
significant spikes in infections of viral hepatitis, as well as HIV, in
a short period of time among people who inject drugs continue to occur
throughout the country. Syringe Services Providers (SSPs) are first
responders to the opioid and infectious diseases crisis effectively
help prevent drug overdoses and new HIV and hepatitis infections. They
have the knowledge, contacts, and ability to reach people who use
drugs; they provide naloxone and other overdose prevention resources;
and they connect people to medical care and support, including
Substance Use Disorder treatment. This program, which is only funded at
$13 million, increases prevention, testing, and linkage to care efforts
to combat increasing new infections and is strongly needed to provide a
strong on the ground response to this crisis. These services are
urgently needed, and adequate funding would provide a critical down
payment for services needed to help stop the spread of opioid-related
infectious diseases. We urge you to fund the CDC's Infectious Diseases
and Opioid Epidemic program in FY2022 at the $120 million requested in
the president's FY2021 budget, an increase of $107 million over FY2021.
Syringe Services Programs
The Department of Health and Human Services has said that syringe
service programs (SSPs) are a proven, evidence-based, and effective
tool in HIV and hepatitis prevention. Beyond providing access to
sterile syringes, SSPs connect people to substance use treatment, HIV
and hepatitis testing, and other supportive services. These cost-
effective programs must be expanded, especially in areas hardest hit by
the opioid epidemic. SSPs have also been providing COVID-19 related
services to vulnerable populations during the pandemic. The FY2021
appropriations bill continued a harmful policy rider that restricts the
use of federal funds for the purchase of sterile syringes, which
negatively impacts the ability of state and local public health groups
from expanding SSPs. We urge you to remove all restrictions on federal
funding for syringe service programs in those jurisdictions that are
experiencing or at risk for a significant increase in HIV or hepatitis
infections due to injection drug use.
Minority HIV/AIDS Initiative (MAI)
Racial and ethnic minorities in the U.S. are disproportionately
impacted by HIV/AIDS. African Americans, more than any other racial/
ethnic group, continue to bear the greatest burden of HIV in the U.S.
Three out of four new HIV infections occur among people of color. While
there have been consistent decreases in new HIV infections among
certain populations, HIV infections are not decreasing among Black and
Latinx gay and bisexual men.
The Minority HIV/AIDS Fund supports cross-agency demonstration
initiatives to support HIV prevention, care and treatment, and outreach
and education activities across the federal government. MAI programs at
the Substance Abuse and Mental Health Administration target specific
populations and provide prevention, treatment, and recovery support
services, along with HIV testing and linkage service when appropriate,
for people at risk of mental illness and/or substance abuse. We urge
you fund the Minority HIV/AIDS Fund at $105 million, and SAMHSA's MAI
program at $160 million in FY2022, an increase of $49.6 million and $44
million over FY2021 levels, respectively. We also urge you to fund
Minority AIDS Initiative programs across HHS agencies at $610 million
in FY2022.
We thank you for your continued leadership and support of these
critical programs for so many people living with HIV, and the
organizations and communities that serve them nationwide.
Please do not hesitate to be in touch for more information
regarding HIV appropriations with our Vice President and Chief Advocacy
Officer, Carl Baloney, Jr., at [email protected].
Sincerely.
[This statement was submitted by Jesse Milan, Jr., President & CEO,
AIDS United.]
______
Prepared Statement of the Alzheimer's Association and Alzheimer's
Impact Movement
The Alzheimer's Association and Alzheimer's Impact Movement (AIM)
appreciate the opportunity to submit outside witness testimony on the
Fiscal Year (FY) 2022 appropriations for Alzheimer's and other dementia
research and public health activities at the U.S. Department of Health
and Human Services. Specifically, we respectfully request a $289
million increase for Alzheimer's research at the National Institutes of
Health (NIH) and $20 million for implementation of the Building Our
Largest Dementia (BOLD) Infrastructure for Alzheimer's Act (P.L. 115-
406) at the Centers for Disease Control and Prevention (CDC).
The Alzheimer's Association is the world's leading voluntary health
organization in Alzheimer's care, support, and research. It is the
nonprofit with the highest impact in Alzheimer's research worldwide and
is committed to accelerating research toward methods of treatment,
prevention, and, ultimately, a cure. AIM is the advocacy affiliate of
the Alzheimer's Association, working in strategic partnership to make
Alzheimer's a national priority. Together, the Alzheimer's Association
and AIM advocate for policies to fight Alzheimer's disease, including
increased investment in research, improved care and support, and
development of approaches to reduce the risk of developing dementia.
alzheimer's impact on american families and the economy
Alzheimer's is a progressive brain disorder that damages and
eventually destroys brain cells, leading to a loss of memory, thinking,
and other brain functions. Ultimately, Alzheimer's is fatal. We have
yet to celebrate the first survivor of this devastating disease.
In addition to the suffering caused by the disease, Alzheimer's is
also creating an enormous strain on the health care system, families,
and federal and state budgets. The annual cost for all individuals with
Alzheimer's or other dementia will total $355 billion for health care,
long-term care, and hospice care in 2021. This does not include the
over $250 billion in unpaid caregiver costs. The U.S. taxpayer-funded
federal health care programs Medicare and Medicaid are expected to
cover about $239 billion, or 67 percent, of these costs this year.
While an estimated 6.2 million Americans age 65 and older are currently
living with Alzheimer's, nearly 13 million Americans will have
Alzheimer's by 2050 and costs will exceed $1.1 trillion (in 2021
dollars). Alzheimer's and other dementia threaten to bankrupt families,
businesses, and our health care system.
investing in alzheimer's treatments
The Food and Drug Administration (FDA) recently approved the first
treatment for Alzheimer's disease since 2003 and the first to address
the underlying biology of Alzheimer's disease. The FDA determined there
is substantial evidence that aducanumab (marketed as Aduhelm) reduces
amyloid plaques in the brain and that the reduction in these plaques is
reasonably likely to predict important benefits to patients.
This approval represents an important step forward in Alzheimer's
research. This new treatment is pivotal, while not a cure. This is the
first of a number of new treatments to come. We recognize the drug may
work differently for everyone who takes it, and may not work for some
individuals. Importantly, aducanumab was studied in and appropriate for
people living with early Alzheimer's dementia and mild cognitive
impairment (MCI) due to Alzheimer's who showed evidence of a buildup of
amyloid plaques in the brain. The therapy has not yet been tested on
people with more advanced cases of dementia or Alzheimer's disease.
The recent years of increased investment provided by Congress to
NIH have been integral to this and other promising therapeutic
approaches to treating Alzheimer's disease. For example, NIH supported
basic science investigations behind the discovery of immunotherapies
like aducanumab, as well as translational research for next-generation
immunotherapies. Additionally, the selection of participants for
aducanumab clinical trials hinged on amyloid PET imaging, a technology
that would not exist today without the publicly-funded research
supported by NIH. The federal commitment, combined with unprecedented
philanthropic support, provides the foundation for an optimistic view
of the future, which is needed because there is much work to be done.
This is just the beginning of meaningful treatment advances.
History has shown us that approvals of the first drug in a new category
invigorates the field, increases investments in new treatments, and
encourages greater innovation. We are hopeful that this drug is just
the beginning for better treatments to come. Looking at the big picture
of science, there is a crucial need for effective treatment options for
diverse populations living in all stages of Alzheimer's. Alzheimer's
must be addressed through multiple different pathways--more than just
amyloid--with an eye toward effective combination therapies,
pharmacological and nonpharmacological, that work at different stages
of the disease.
While recent NIH funding increases have laid the foundation for
breakthroughs in diagnosis, treatment, and prevention, and enabled
significant advances in understanding the complexities of Alzheimer's,
there is still much left to be done. We cannot leave any stone
unturned. Investment in Alzheimer's research is only a fraction of
what's been applied over time, with great success, to address other
major diseases. Between 2000 and 2017, the number of people dying from
Alzheimer's increased by 145 percent while deaths from other major
diseases have decreased significantly or remained approximately the
same. It is vitally important that NIH continues to build upon
promising research advances. An increase of $289 million in Alzheimer's
research at NIH in FY2022 would enable scientists to conduct more
inclusive, efficient, and practical clinical trials; increase knowledge
of risk and protective factors in individuals and across diverse
populations; discover better biomarkers to detect disease and monitor
treatment response; pursue a precision medicine approach to detect the
disease earlier and tailor treatment plans to an individual's unique
symptoms and risk profile; and leverage emerging digital technologies
and big data to speed discoveries. We need to continue to increase
investment in Alzheimer's and dementia research to maximize every
opportunity for success.
addressing alzheimer's as a public health crisis
As scientists continue to search for ways to cure, treat, or slow
the progression of Alzheimer's through medical research, public health
plays a critical role in promoting cognitive function and reducing the
risk of cognitive decline. Now more than ever it is apparent how
crucial it is to have an established infrastructure in place to respond
to public health threats.
In 2018, Congress acted decisively to address Alzheimer's as an
urgent and growing public health threat through the passage of the
bipartisan BOLD Act. This law authorizes $100 million over five years
for CDC to build a robust Alzheimer's public health infrastructure
across the country focused on public health actions that can allow
individuals with Alzheimer's to live in their homes longer and delay
costly long-term nursing home care. Congress appropriated $10 million
for the first year of BOLD's implementation in FY20, which allowed CDC
to award funding to three Public Health Centers of Excellence (PHCOE),
focused on risk reduction, caregiving, and early detection, and 16
public health departments across the country. These state, local, and
tribal public health department recipients are creating statewide
dementia coalitions, hiring dementia coordinators, and developing or
updating Alzheimer's and other dementia strategic plans. The $15
million Congress appropriated for the second year of BOLD's
implementation in FY21 will help fund additional public health
departments and expand the impact of this crucial work into more
communities across the country.
The Alzheimer's Association is grateful to be leading the Dementia
Risk Reduction PHCOE, focusing on community-level actions to reduce the
risk of developing Alzheimer's and other dementia. Researchers are
increasingly studying the impact that lifestyle behaviors may have on
the risk of developing Alzheimer's and other dementia. The future of
reducing Alzheimer's could be in treating the whole person with a
combination of drugs and modifiable risk factor interventions, as we do
now with heart disease. The Center will work with public health
agencies on addressing social determinants of health with respect to
dementia risk; capacity building to enable smaller public health
agencies to engage in dementia risk reduction activities; and
partnering with health systems in their communities to advance risk
reduction.
Over 65 percent of American adults have at least one risk factor
for dementia. Although risk factors like age, genetics, and family
history cannot be changed, other risk factors can be modified to reduce
the risk of cognitive decline and dementia. Examples of modifiable risk
factors are physical activity, smoking, education, staying socially and
mentally active, blood pressure, and diet. In fact, the 2020
recommendations of The Lancet Commission on dementia prevention,
intervention, and care suggest that addressing modifiable risk factors
might prevent or delay up to 40 percent of dementia cases.
The Alzheimer's Association is leading a five-year clinical trial
to evaluate a two-year intervention to see whether lifestyle
interventions that simultaneously target multiple risk factors can
protect cognitive function in older adults at increased risk for
cognitive decline. The U.S. Study to Protect Brain Health Through
Lifestyle Intervention to Reduce Risk (U.S. POINTER) will evaluate the
effects of lifestyle interventions, like physical exercise, a healthier
diet, cognitive and social stimulation, and self-management of heart
and vascular health, on changes in cognitive function. It is crucial
that forthcoming findings from studies like U.S. POINTER are translated
into public health interventions across the country. Investing now in a
robust public health infrastructure ensures cutting edge research can
be effectively and efficiently disseminated into local communities.
While these BOLD implementation efforts are important steps
forward, and we are grateful to this Subcommittee and Congress for the
initial funding, CDC must receive the full $20 million authorized in
the law for FY2022 to ensure the meaningful impact that Congress
intended. The Alzheimer's Association and AIM urge Congress to include
the full $20 million for the third year of BOLD's implementation at CDC
in FY2022. Activities supported by the requested $20 million in FY22
would enable CDC to award additional PHCOEs, focused on important
priorities such as Tribal Health and avoiding preventable
hospitalizations, and expand the number of state, local, and tribal
public health departments across the country that receive funding for
Alzheimer's public health activities. Finally, as Alzheimer's is one of
the most prevalent chronic diseases facing our nation, we look forward
to the day that the Subcommittee and CDC elevate Alzheimer's and other
dementia to the Division level as with other major chronic diseases.
conclusion
The Alzheimer's Association and AIM appreciate the steadfast
support of the Subcommittee and its priority setting activities. We
urge the Subcommittee and Congress to provide an additional $289
million for Alzheimer's research activities at NIH and $20 million for
full implementation of the BOLD Infrastructure for Alzheimer's Act at
CDC in FY 2022.
______
Prepared Statement of the Alzheimer's Foundation of America
On behalf of the Alzheimer's Foundation of America (AFA), a
national nonprofit that unites more than 2,000 member organizations in
the goal of providing support, services and education to individuals,
families and caregivers affected by Alzheimer's disease and related
dementias nationwide, I am submitting the following budget requests for
your consideration as you prepare fiscal year (FY) 2022 appropriations
levels for the federal budget.
For federal programs that impact those living with dementia and
their family caregivers, AFA recommends the following budget
allocations for FY '22:
--an additional $289 million for a total $3.4 billion for Alzheimer's
disease clinical research at the National Institutes of Health/
National Institute on Aging (NIH/NIA);
--$560 million to fund the Brain Research through Advancing
Innovative Neurotechnologies (BRAIN) Initiative, a trans-agency
effort to arm researchers with revolutionary tools to
fundamentally understand the neural circuits that underlie the
healthy and diseased brain;
--$46.1 billion (a $3.2 billion increase over FY '21) for total
spending at the NIH;
--support for President Biden's call for $6.5 billion to launch the
Advanced Research Projects Agency for Health (ARPA-H) at NIH;
--an additional $50 million to fund caregiver supports and services
provided by Older Americans' Act (OAA) programs administered by
the Administration for Community Living (ACL), including a $7.5
million increase for the Alzheimer's Disease Program for a
total expenditure of $35 million in FY '22; and
--$20.5 million to support BOLD Act initiatives, including a $500,000
increase for the Healthy Brain Initiative and $4 million for
fall prevention at the Centers for Disease Control and
Prevention (CDC).
National Institutes of Health/National Institute on Aging (NIH/NIA):
NIA sponsors and conducts the lion's share of federal aging-related
research, including research into Alzheimer's disease and related
dementias, and this pioneering science contributes significantly to the
improved care and quality of life of older adults. A key NIA priority
is translating research into better and more efficient care through the
development of effective interventions that are disseminated to health
care providers, patients, and caregivers. These interventions for the
prevention, early detection, diagnosis, and treatment of disease will
help reduce the burden of illness for older adults and lower cost of
care.
AFA is extremely grateful to the Subcommittee for recent increases
in federal funding for Alzheimer's disease research at NIH/NIA.
Additional resources for fighting Alzheimer's disease and related
dementias at NIH have greatly increased our chances that promising
research gets funded as we move closer to the goal of finding a cure or
disease-modifying treatment by 2025 as articulated in the National Plan
to Address Alzheimer's Disease.
Yet, meaningful treatment is still some ways off and basic science
into dementia--the type of research funded through NIH--remains vital
to finding a cure.
AFA asks the Subcommittee to build upon past progress and continue
making the battle against Alzheimer's disease a national priority. To
this end, AFA urges the Subcommittee to provide an additional $289
million, for a total of approximately $3.4 billion for Alzheimer's
disease clinical research at NIH in FY '22.
The BRAIN Initiative is a large-scale effort to accelerate
neuroscience research by equipping researchers with the tools and
insights necessary for treating a wide variety of brain disorders,
including Alzheimer's disease, schizophrenia, autism, epilepsy, and
traumatic brain injury. By mapping whole brains in action, the ability
to identify thousands of brain cells at a time and development of
innovative brain scanners, BRAIN Initiative research advances and tools
are needed to better understand the brain and cognitive functioning.
AFA is asking that $560 million be allocated to conduct BRAIN
Initiative research for FY '22.
AFA also urges the Subcommittee to budget at least $46.1 billion
for total NIH spending in FY '22, a $3.2 billion increase over the
NIH's program level funding in FY '21, as recommended by the Ad Hoc
Group for Medical Research. This funding level would allow for
meaningful growth above inflation in the base budget that would expand
NIH's capacity to support promising science in all disciplines. It also
would ensure that funding from the Innovation Account established in
the 21st Century Cures Act would supplement the agency's base budget,
as intended, through dedicated funding for specific programs.
AFA also supports the President's call for an additional $6.5
billion to launch the Advanced ARPA-H at NIH. ARPA-H would leverage
existing public sector basic science research programs along with
private sector efforts to accelerate development of new capabilities
for disease prevention, detection, and treatment and overcome
bottlenecks that have limited progress in areas such as Alzheimer's
disease. Any funding for ARPA-H, however, should not come from the
existing programming budget for NIH and should be considered an
additional appropriation to AFA's $46.1 billion request for all of NIH.
Centers for Disease Control and Prevention (CDC):
The Building Our Largest Dementia (BOLD) Infrastructure for
Alzheimer's Act requires CDC to establish Centers of Excellence in
Public Health Practice dedicated to promoting Alzheimer's disease
management and caregiving interventions, as well as educating the
public on Alzheimer's disease and brain health, will establish
Alzheimer's disease as a public health issue, increasing American
awareness and care training around the disease. To fund BOLD Act
initiatives at CDC, AFA is requesting $20 million in funding for FY
'22.
For older adults--especially for those living with dementia--falls
are common, costly, and often preventable. They represent the leading
cause of injury-related death among adults age 65 years of age and
older. CDC's National Center for Injury Prevention and Control
developed tools for clinicians and other health care partners to
identify and address falls and fall risk. AFA urges a continued
investment of $4 million to continue funding fall prevention programs
at CDC.
Administration for Community Living (ACL):
AFA is requesting a $50 million increase for vital ACL programming
impacting those living with dementia, including a $7.5 million increase
to the Alzheimer's Disease Program for a total funding of $35 million
in FY '22. In addition, AFA is requesting that the following amounts be
allocated to the following Older Americans' Act (OAA) programs
administered by ACL:
--National Family Caregiver Support Program (NFCSP): NFCSP provides
grants to states and territories, based on their share of the
population aged 70 and over, to fund a range of supportive
services that assist family and informal caregivers in caring
for those with dementia at home for as long as possible, thus
providing a more person-friendly and cost-effective approach to
institutionalization. AFA urges that an additional $24.5
million (for a total of $213.6 million) be allocated in FY '22
to support this important program.
--Lifespan Respite Care Program (LRCP): AFA urges the Subcommittee to
allocate a minimum of $10 million--a $2.9 million increase--to
LRCP in FY '22. LRCP provides competitive grants to state
agencies working with Aging and Disability Resource Centers and
non-profit state respite coalitions and organizations to make
quality respite care available and accessible to family
caregivers regardless of age or disability.
--Falls Prevention: In response to COVID, several community-based
fall prevention interventions, supported with ACL investments,
have transitioned to a digital environment in cases where they
can safely be implemented in the home. AFA, therefore, urges
$10 million, a $5 million increase over FY '21 funding, be
allocated so ACL can continue vital fall prevention activities
at ACL.
--Home Delivered Nutrition Program: This vital program provides
grants to states for nutrition services for older people,
including many living with dementia. In addition to healthy
meals, the programs provide a range of services including being
an important link to in-home and community-based supports such
as homemaker and home-health aide services, transportation,
home repair and modification, and falls prevention programs.
AFA calls for a $10.1 million increase, or $286.3 million, for
home delivered nutrition programs in FY '22.
AFA understands that during this time of crisis, Congress is
working hard to stem fallout of both the human and fiscal toll of
COVID-19. We are grateful for your work and urge that the Subcommittee
continues making services and supports available to our nation's most
vulnerable populations--including those older Americans with chronic
conditions like Alzheimer's disease--a priority. We know that through
determination, sacrifice and resilience, Americans will rise to the
challenge and take the necessary steps to mitigate the fallout of this
public health emergency.
AFA thanks the Subcommittee for the opportunity to present our
recommendations and looks forward to working with you and your staff
through the appropriations process. Please contact me at
[email protected] or Eric Sokol, AFA's senior vice president of
public policy, at [email protected], if you have any questions or
require further information.
Sincerely.
[This statement was submitted by Charles J. Fuschillo, Jr.,
President and CEO, Alzheimer's Foundation of America.]
______
Prepared Statement of the American Academy of Allergy,
Asthma & Immunology
Chairwoman Murray, Ranking Member Blunt, and Members of the
Subcommittee, the American Academy of Allergy, Asthma, & Immunology
(AAAAI) thanks you for the opportunity to submit written testimony on
the U.S. Department of Health and Human Services (HHS) Fiscal Year (FY)
2022 appropriations bill. AAAAI respectfully requests the subcommittee
to include $12.2 million in funding for the Consortium on Food Allergy
Research (CoFAR) within the National Institute of Allergy and
Infectious Disease (NIAID) at the National Institutes of Health (NIH).
In addition, we request report language reflecting the importance of
NIH engaging in trans-NIH research on food allergies. Also, the AAAAI
supports funding of $100 million for the National Healthcare Safety
Network which enables the Centers for Disease Control and Prevention
(CDC) to target prevention of healthcare acquired and antimicrobial
resistant infections and improve antibiotic prescribing.
Established in 1943, AAAAI is a professional organization with more
than 7,000 members in the United States, Canada, and 72 other
countries. This membership includes board certified allergist/
immunologists, other medical specialists, allied health and related
healthcare professionals--all with a special interest in the research
and treatment of patients with allergic and immunological diseases.
food allergies
Food allergies affect 32 million Americans, including 6 million
children. Each year, more than 200,000 Americans require emergency
medical care for allergic reactions to food--equivalent to one trip to
the emergency room every three minutes.
The Consortium on Food Allergy Research (CoFAR) was established by
the National Institutes of Health (NIH) within the National Institute
of Allergy and Infectious Disease (NIAID) in 2005. Over the following
16 years, CoFAR discovered genes associated with an increased risk for
peanut allergy and has also identified the most promising potential
treatments for egg and peanut immunotherapy, among many other
accomplishments. Breakthroughs like these, scaled across other major
food allergies, can significantly improve the quality of life for tens
of millions of Americans. Its annual $6.1 million budget is a
relatively small portion within NIH's almost $40 billion budget, yet
CoFAR has been able to achieve massive strides in the study of food
allergy prevention and treatment.
AAAAI enthusiastically supports an increase in funding for CoFAR of
$6.1 million, annually, bringing its yearly budget up to $12.2 million.
With its relatively low current level of funding, CoFAR has been able
to accomplish breakthroughs in the under-researched field of food
allergies. It is crucial that we continue investing at proportional
levels given the scale of this condition which impacts 10.8 percent of
the U.S. population.
AAAAI also requests that the Subcommittee's report accompanying the
FY22 Labor/HHS appropriation reflects the importance of trans-NIH
research on food allergies. AAAAI strongly supports the following NIAID
report language submitted by Senator Blumenthal that acknowledges the
groundbreaking work of CoFAR and encourages robust investment to expand
its research breadth and network.
Food Allergies.--The Committee recognizes the serious issue of food
allergies which affect approximately eight percent of children
and ten percent of adults in the U.S. The Committee commends
the ongoing work of NIAID in supporting a total of 17 clinical
sites for this critical research, including seven sites as part
of the Consortium of Food Allergy Research (CoFAR). The
Committee includes $12,200,000, an increase of $6,100,000, for
CoFAR to expand its clinical research network to add new
centers of excellence in food allergy clinical care and to
select such centers from those with a proven expertise in food
allergy research.
In addition to the AAAAI, the CoFAR funding request and report
language are supported by the American College of Allergy, Asthma &
Immunology; Allergy & Asthma Network; Asthma and Allergy Foundation of
America; Food Allergy & Anaphylaxis Connection Team; Food Allergy
Research and Education; and International FPIES Association.
antimicrobial resistance (amr) and penicillin allergy
The growing threat of antimicrobial resistance, combined with the
dwindling pipeline of novel antibiotic research, requires policies that
prevent inappropriate use of antibiotics. One of the primary ways to
combat this threat begins with penicillin--the most commonly reported
drug allergy. According to the CDC, approximately 10 percent of the
U.S. population report being allergic to penicillin, yet 9 out of 10
patients reporting a penicillin allergy are not truly allergic when
formally evaluated, such that fewer than one percent of the population
is truly allergic to penicillin. More recently, the CDC cited the
importance of correctly identifying if patients are penicillin-allergic
in decreasing the unnecessary use of broad-spectrum antibiotics in its
2018 update of Antibiotic Use in the United States: Progress and
Opportunities. The AAAAI strongly supports more widespread and routine
use of penicillin allergy evaluation for patients with a self-reported
history of allergy to penicillin. Evaluation can accurately identify
patients who, despite reporting a history of penicillin allergy, can
safely receive penicillin.
The AAAAI supports funding of $100 million for the National
Healthcare Safety Network which enables CDC to target prevention of
healthcare acquired and antimicrobial resistant infections and improve
antibiotic prescribing. The Antibiotic Resistance Solutions Initiative
will benefit from significant new resources to achieve the goals
outlined in the National Action Plan for Combating Antibiotic-Resistant
Bacteria, including strengthening antibiotic stewardship to promote
best practices for prescribing antibiotics such as penicillin.
AAAAI also wishes to express its appreciation to the subcommittee
for the inclusion of language regarding the importance of penicillin
allergy testing in the FY20 appropriations bill. The discovery of
penicillin opened the door to medical innovation allowing surgeries to
be performed, organs to be transplanted, as well as combat wounds and
burn victims to be treated. AAAAI encourages more widespread and
routine penicillin allergy evaluation for patients with a history of
allergy to penicillin or another beta-lactam drug (e.g., ampicillin or
amoxicillin). Penicillin allergy evaluation can accurately identify
patients who, despite reporting a history of penicillin allergy, can
safely receive penicillin. On behalf of the patients we serve, thank
you for your leadership in giving penicillin allergy testing the
attention it deserves.
Thank you for your consideration of these FY22 appropriations
requests. Please contact Sheila Heitzig, JD, MNM, CAE, AAAAI Director
of Practice and Policy, at [email protected] if you have any questions
or would like additional information.
______
Prepared Statement of the American Academy of Pediatrics
The American Academy of Pediatrics (AAP), a non-profit professional
organization of 67,000 primary care pediatricians, pediatric medical
subspecialists, and pediatric surgical specialists dedicated to the
health, safety, and well-being of infants, children, adolescents, and
young adults, appreciates the opportunity to submit this statement for
the record in support of strong federal investments in children's
health in Fiscal Year (FY) 2022 and beyond.
AAP urges all Members of Congress to put children first when
considering short and long-term federal spending decisions, and
supports funding levels for the following programs: $50 million for
Pediatric Subspecialty Loan Repayment (HRSA), $50 million for Firearm
Injury and Mortality Prevention Research (CDC/NIH), $10 million for
Pediatric Mental Health Care Access Grants (HRSA), $12 million for
implementation of Scarlett's Sunshine Act (CDC/HRSA), $22.334 million
for Emergency Medical Services for Children (HRSA), $280 million for
the National Center for Birth Defects and Developmental Disabilities
(CDC), $271.2 million for Global Immunizations (CDC), and $15 million
and report language for the Vaccine Awareness Campaign to Champion
Immunization Nationally and Enhance Safety (VACCINES) Act (CDC).
Pediatric Subspecialty Loan Repayment Program (HRSA):
FY 22 Request: $50 Million; FY 21 Level: Never Funded.--The AAP
requests $50 million in initial funding for the Pediatric Subspecialty
Loan Repayment Program, a Title VII health professions program to
improve access to care for children with special health care needs by
offering loan repayment to pediatric subspecialists and child mental
health providers who agree to serve in an underserved area. The United
States' supply of pediatric subspecialists is inadequate to meet
children's health needs. Many children must wait more than 3 months for
an appointment with a pediatric subspecialist, and approximately 1 in 3
children must travel 40 miles or more to receive care from a
pediatrician certified in certain subspecialties such as developmental
behavioral pediatrics. Spotlighting the needs of children with autism
spectrum disorder (ASD), as an example, there are approximately 1.5
million children with ASD but there are only about 700 practicing
board-certified developmental-behavioral pediatricians. The national
wait time for a pediatric developmental evaluation is 5.4 months. In
terms of equity, ASD prevalence among Hispanic children is about 16%
lower than among white and black children, which suggests that more
Hispanic children with autism are not being identified. In addition,
black children with ASD are significantly less likely than white
children to have a first evaluation by the age of three.
Firearm Injury and Mortality Prevention Research (CDC/NIH):
FY 22 Request: $50 Million Total; FY 21 Level: $25 Million Total.--
The AAP is tremendously appreciative of and applauds Congress for
continuing to provide $25 million total, split evenly between CDC and
NIH, for firearm injury and mortality prevention research in FY 21. In
the midst of the COVID-19 pandemic, communities across the U.S.
continue to suffer from the public health crisis of firearm-related
injuries and deaths with early data showing 2020 being a record-
breaking year for gun violence, injuries, and deaths. A public health
approach to firearm violence prevention is urgently needed to promote
health equity and address the disproportionate burden of this epidemic
on communities of color. The foundation of this approach is rigorous
research that can accurately quantify and describe the facets of an
issue and identify opportunities for reducing its related morbidity and
mortality. The initial investments in FY20 and FY21 are important, but
increased funding is still needed to overcome the decades-long lack of
federal funding that set back our nation's response to the public
health issue of firearm-related morbidity and mortality. Over time,
additional funding can generate research into important issues such as
the best ways to prevent unintended firearm injuries and fatalities
among women and children; the most effective methods to prevent
firearm-related suicides; the measures that can best prevent the next
shooting at a school or public place; and numerous other vital public
health questions. Continued and expanded investments are essential to
the success of this important work.
Pediatric Mental Health Care Access Grants (HRSA):
FY 22 Request: $10 Million; FY 21 Level: $10 Million.--The AAP
appreciates the additional funds included in the American Rescue Plan
for the Pediatric Mental Health Care Access Grants, in recognition of
the impact of COVID-19 on child and adolescent mental health, and urges
Congress to continue providing $10 million for FY 22 appropriations.
This program supports the development of new statewide or regional
pediatric mental health care telehealth access programs, as well as the
improvement of already existing programs. Research shows pervasive
shortages of child and adolescent mental/behavioral health specialists
throughout the U.S. Integrating mental health and primary care has been
shown to substantially expand access to mental health care, improve
health and functional outcomes, increase satisfaction with care, and
achieve costs savings.
Activities Authorized under Scarlett's Sunshine Act (CDC/HRSA):
FY 22 Request: $12 Million; FY 21: Level: N/A.--The AAP urges
Congress to provide first-time appropriations of $12 million to
implement the Scarlett's Sunshine Act. Little is known about the
tragic, sudden and unexpected deaths of young children because of
variations in investigations and death certifications. Enacted in
December 2020, this law will help states better understand sudden
unexpected infant death and sudden unexpected death in childhood,
facilitate data collection and analysis to improve prevention, and
support grieving families. Funds should support work at both CDC and
HRSA's Maternal Child Health Bureau given their complementary efforts
on this issue.
Emergency Medical Services for Children (HRSA):
FY 2022 Request: $22.334 Million; FY 21 Level: $22.334 Million.--
The AAP urges the committee to maintain $22.334 million in funding for
the Emergency Medical Services for Children (EMSC) Program in FY 22.
EMSC is the only federal program that focuses specifically on improving
the pediatric components of the emergency medical services (EMS)
system. EMSC aims to ensure state of the art emergency medical care is
available for the ill and injured child or adolescent, pediatric
services are well integrated into an EMS system backed by optimal
resources, and that the entire spectrum of emergency services is
provided to all children and adolescents no matter where they live.
National Center for Birth Defects and Developmental Disabilities (CDC):
FY 22 Request: $280 Million; FY 21 Level: $167.8 Million.--The AAP
requests $280 million for FY 22 for the National Center for Birth
Defects and Developmental Disabilities (NCBDDD), including $100 million
for Surveillance for Emerging Threats to Mothers and Babies (SET-NET).
This would allow the program to scale nationally and serve as the
nationwide preparedness and response network the United States needs to
protect pregnant individuals and infants from emerging public health
threats. According to the CDC, birth defects affect 1 in 33 babies and
are a leading cause of infant death in the United States. NCBDDD
conducts important research on fetal alcohol syndrome, infant health,
autism, attention deficit and hyperactivity disorders, congenital heart
defects, and other conditions like Tourette Syndrome, Fragile X, Spina
Bifida and Hemophilia. NCBDDD supports extramural research in every
State and has played a crucial role in the country's response to the
Zika virus, as well as COVID-19.
Global Immunization--Polio and Measles/Other (CDC):
FY 22 Request: $271.2 Million ($176 Million for Polio and $50
Million for Measles/Other); FY 21 Level: $226 Million ($176 Million for
Polio and $50 million for Measles/Other).--Vaccines are one of the most
cost-effective and successful public health solutions available. The
CDC provides countries with technical assistance and disease
surveillance support, with a focus on eradicating polio, reducing
measles deaths, and strengthening routine vaccine delivery. Global
mortality attributed to measles declined by 79% between 2000 and 2015
thanks to expanded immunization, saving an estimated 20.3 million
lives. Unfortunately, the gains from global immunization are in
jeopardy. During the COVID-19 pandemic, many countries diverted
resources set aside for polio and routine immunizations to fight the
pandemic. To finance immunization gaps in countries and recover from
pandemic-related disruptions requires an additional $255 million over
the next three years. Failing to close these gaps will leave millions
of children at risk and will compromise U.S. global health security due
to increased possibility of importing highly infectious diseases like
measles into the U.S.
Activities Authorized under the VACCINES Act (CDC):
FY 22 Request: $15 Million; FY 21 Level: N/A.--The AAP is very
appreciative that Congress specifically included the Vaccine Awareness
Campaign to Champion Immunization Nationally and Enhance Safety
(VACCINES) Act as part of Section 2302 of the American Rescue Plan that
provided $1 billion to improve vaccine confidence for both COVID-19 and
routine immunizations. We urge Congress to include $15 million
authorized by the VACCINES Act for CDC to research vaccine hesitancy
and establish an evidence-based public awareness campaign to help
improve vaccination rates across the lifespan. We also urge Congress to
request a report on the progress of these activities at the CDC.
There are many ways Congress can help meet children's needs and
protect their health and well-being. Adequate funding for children's
health programs is one of them. The American Academy of Pediatrics
looks forward to working with Members of Congress to prioritize the
health of our nation's children in FY 2022 and beyond. If we may be of
further assistance, please contact the AAP Department of Federal
Affairs at [email protected]. Thank you for your consideration.
[This statement was submitted by Lee Savio Beers, MD, FAAP,
President,
American Academy of Pediatrics.]
______
Prepared Statement of the American Alliance of Museums
Chairwoman Murray, Ranking Member Blunt, and members of the
subcommittee, thank you for the opportunity to submit this testimony.
My name is Laura Lott, and I am President and CEO of the American
Alliance of Museums (AAM). I urge you to provide the Office of Museum
Services (OMS) within the Institute of Museum and Library Services
(IMLS) with $80 million for fiscal year (FY) 2022, an increase of $39.5
million. We request that $2.5 million of this increase be directed to
explore establishing, and to fund projects related to, a roadmap to
strengthen the structural support for a museum Grants to States program
administered by OMS, as authorized by the Museum and Library Services
Act, in addition to the agency's current critical direct grants to
museums.
AAM--representing more than 35,000 individual museum professionals
and volunteers, museums of all types, and corporate partners serving
the museum field--stands for the broad scope of the museum community.
I want to express the museum field's gratitude for the $40.5
million in funding for OMS in FY 2021, and we applaud the bipartisan
group of 41 Senators who recently wrote to you in support of FY 2022
OMS funding. We also applaud the President's budget proposal for
additional funding for OMS for the grants program authorized by the
African American History and Culture Act and the grants program
authorized by the National Museum of the American Latino Act as steps
in the right direction. OMS is a vital investment in protecting our
nation's cultural treasures, educating students and lifelong learners
alike, and bolstering local economies. During the COVID-19 pandemic,
OMS has provided critical leadership to the museum community through
its CARES Act grants. For example, the agency has been providing
science-based information and recommended practices to reduce the risk
of transmission of COVID-19 to staff and visitors engaging in the
delivery of museum services.
Through the IMLS CARES Act Grants to Museums and Libraries, IMLS
awarded $13.8 million to 68 museums and libraries to support their
response to the coronavirus pandemic. IMLS received 1088 applications
from museums but was only able to fund 39 awards, fewer than 4 percent
of the applications, for a total of $8.28 million--far below the $261.5
million requested. Unfortunately, none or very little of the $200
million allocated to IMLS in the American Rescue Plan is expected to be
awarded to museums.
Museums are a robust and diverse business sector, including African
American museums, aquariums, arboreta, art museums, botanic gardens,
children's museums, culturally-specific museums, historic sites,
historical societies, history museums, maritime museums, military
museums, natural history museums, planetariums, presidential libraries,
public gardens, railway museums, science and technology centers, and
zoos.
Museums are economic engines and job creators: According to Museums
as Economic Engines: A National Report, pre-pandemic U.S. museums
supported more than 726,000 jobs and contributed $50 billion to the
U.S. economy per year, including significant impact on individual
states. For example, the total financial impact that museums have on
the economy in the state of Washington is $1.01 billion, supporting
14,145 jobs. For Missouri it is a $852 million impact, including 13,653
jobs. Nationally, museums spend more than $2 billion yearly on
education activities and the typical museum devotes 75% of its
education budget to K-12 students.
IMLS is the primary federal agency responsible for helping museums
connect people to information and ideas. OMS supports all types of
museums--from art museums to zoos--by awarding grants that help them
better serve their communities. OMS awards grants in every state to
help museums digitize, enhance, and preserve collections; provide
teacher professional development; and create innovative, cross-
cultural, and multi-disciplinary programs and exhibits for schools and
the public. Congress reauthorized IMLS at the end of 2018, with wide
bipartisan support. OMS grants to museums are highly competitive and
decided through a rigorous peer-review process. In addition to the
dollar-for-dollar match generally required of museums, grants often
spur more giving by private foundations and individual donors.
There is high demand for funding from OMS. In FY 2020 OMS received
784 applications requesting nearly $146 million, but current funding
has allowed the agency to fund only a small fraction of the highly
rated grant applications it receives. $80 million would allow OMS to
double its grant capacity for museums, funds that museums will need to
help recover from the pandemic and continue to serve their communities.
This substantial funding increase would still be greatly shy of the
high demand of $146 million in highly rated grant applications. A
Grants to States program administered by OMS, in addition to the
agency's current direct grants to museums, would merge federal
priorities with state-defined needs, expand the reach of museums, and
increase their ability to serve their communities, address underserved
populations, and meet the needs of the current and future museum
workforce.
Museums are vital to our nation's recovery from this pandemic, and
after sudden and long-term closures, they will require financial
assistance to reopen, maintain their staffs, provide educational
programs to communities, and assist in rebuilding local tourism
economies. PPP 1 and PPP 2, and Shuttered Venue Operators Grants
(limited to museums with theatres with fixed seating) have and will
provide a critical lifeline for many museums. But the museum field will
need robust ongoing support from IMLS, especially as not all museums
were eligible for pandemic relief funds. According to a report by
McKinsey and Company, the arts, entertainment, and recreation sectors
will not fully recover from this public health crisis and muted economy
until 2025.
Recent survey data confirmed that the dire economic harm to museums
caused by the COVID-19 pandemic will result in a long road to recovery
for the field. Three-quarters of museums (76 percent) report that their
operating income fell an average of 40 percent in 2020 while their
doors were closed to the public for an average of 28 weeks due to the
pandemic. Museums have largely been unable to offset losses by cutting
expenditures. Fifteen percent (the equivalent of more than 5,000 US
museums) confirmed there was a ``significant risk of permanent
closure'' or they ``didn't know'' if they would survive the next six
months absent additional financial relief. Nearly half (46 percent) of
museums surveyed report that their total staff size has decreased by an
average of 29 percent compared with pre-pandemic levels. Only 44
percent of all respondents plan to rehire or increase their staff size
in the coming year. Pre-pandemic museums supported 726,000 jobs. Fifty-
nine percent of responding museums were forced to cut back on
education, programming, and other public services due to budget
shortfalls and/or staff reductions during the pandemic. Thirty-nine
percent of responding museums require investments in their building,
HVAC equipment, and other infrastructure to improve energy efficiency
and reduce the environmental impact of their operations. The average
anticipated cost of these improvements is $668,000 per museum.
Despite economic distress, museums have been filling critical gaps
in our communities. During the pandemic, museum professionals--severely
impacted by the pandemic themselves-stepped up by serving the needs of
their communities. They are addressing education gaps and contributing
to the ongoing education of our country's children by providing free
lesson plans, online learning opportunities, and drop-off learning kits
to teachers and families. Museums are using their outdoor spaces to
grow and donate produce to area food banks and are maintaining these
spaces for individuals to safely relax, enjoy nature, and recover from
the mental health impacts of social isolation. They have donated their
PPE and scientific equipment to fight COVID-19, and provided access to
child care and meals to families of health care workers and first
responders. In the midst of financial distress, they are even raising
funds for community relief and providing reliable information on COVID-
19 and vaccinations, some even serving as vaccination sites themselves.
Museums are pivotal to our nation's ability to manage through the
pandemic and recover from it as our nation opens back up.
Here are just a few examples of how OMS helps museums better serve
their communities:
In 2021, the Suquamish Indian Tribe of the Port Madison Reservation
in Washington was awarded a $85,400 Native American/Native Hawaiian
Museum Services grant to update an oral history project conducted from
1981-83 that has guided the development of the Suquamish Museum for
over 30 years. The project will engage the 78 Suquamish elders who are
70 years of age and older to document their biographical, cultural, and
personal knowledge for use in more contemporary programming and museum
exhibits. Although the tribe recognized the need to gather oral
histories during a retreat in 2018, the COVID-19 pandemic not only
increased the sense of urgency but provided time to consider a plan for
the project. Collecting oral histories of experiences in the more
recent past will guide long range planning and help the museum focus
its collections acquisitions for the next foreseeable decades.
In 2020, the Seattle Art Museum in Washington was awarded a
$216,970 Museums for America grant to expand its early learner
initiative known as Artful Beginnings to create increased opportunities
for hands-on arts learning and engagement for children ages 2 through
6, their caregivers, and educators. The focus is on three core Artful
Beginnings programs: Tiny Tots Workshops and Family Fun Storytime, Art
Adventures, and an art-based outdoor preschool curriculum with Tiny
Trees. The museum's three locations--as well as community partner
facilities in South Seattle and South King County--will host the
programs. Programming will focus on engaging traditionally underserved
and lower-income audiences. The project underscores the museum's
commitment to equity and inclusion and will work to engage all
audiences more deeply.
In 2020, Port Townsend Marine Science Society in Washington was
awarded a $49,613 Program Inspire! Grants for Small Museums grant to
complete an exhibition master plan as part of a larger facility
improvement project. The expanded and renovated facility will create an
accessible, unified, cohesive exhibition experience with strong content
linkages and seamless indoor-outdoor integration that gives the feeling
of a journey into the Salish Sea. The process of developing the
exhibition master plan will involve formative evaluation, including
site visits, surveys, focus groups, and consultations with
professionals. Representatives of key stakeholder groups, including
educators and students, volunteers, marine conservation professionals,
and other Salish Sea environmental organizations will provide input on
the plan concept and exhibition content. The center intends to inspire
responsible stewardship of global oceans through the development of
immersive, informative content.
In 2020, the Walt Disney Hometown Museum in Marceline, Missouri,
was awarded a $38,240 Program Inspire! Grants for Small Museums grant
to expand its education and professional development programs for rural
educators. The initiative is the result of a collaborative partnership
that includes museum staff, K-16 educators, and others from the local
community. Educators will have the opportunity to participate in an
immersive learning workshop program where they will experience and
explore place-based learning opportunities alongside guided
instructional planning. The initiative will solidify bonds between the
museum and the community, as educators and museum personnel collaborate
to strengthen their understanding of how local culture connects to
learning.
In 2020, the Missouri Botanical Garden in Saint Louis, Missouri,
was awarded a $202,220 Museums for America grant to create a Butterfly
House Entomology Lab to serve as a functional space for staff and
volunteers to properly care for their invertebrate animal collection
while providing guests an interactive experience. This exhibition will
promote learning experiences focused on the butterfly life cycle,
invertebrate animal conservation, and the field of entomology. The
project also will include the addition of digital components such as
monitors that highlight the characteristics of each display species and
their region of origin. The addition of technology also will allow
virtual field trips to the Butterfly House Entomology Lab.
In closing, I highlight recent national public opinion polling that
shows that 95% of voters would approve of lawmakers who acted to
support museums and 96% want federal funding for museums to be
maintained or increased. Museums have a profound positive impact on
society.
If I can provide any additional information, I would be delighted
to do so. Thank you again for the opportunity to submit this testimony.
[This statement was submitted by Laura L. Lott, President/CEO,
American
Alliance of Museums.]
______
Prepared Statement of the American Association for Cancer Research
Chair Murray, Ranking Member Blunt, and members of the subcommittee
and staff, thank you for the opportunity to submit testimony. I am Dr.
David Tuveson, Director of the Cold Spring Harbor Laboratory Cancer
Center and Chief Scientist for the Lustgarten Foundation, the largest
pancreatic cancer research philanthropic organization. I am submitting
testimony as President of the American Association for Cancer Research
(AACR). On behalf of the AACR's 48,000 members, I ask for your support
for at least $46.1 billion in FY 2022 funding for the National
Institutes of Health (NIH), and $7.6 billion for the National Cancer
Institute (NCI).
We are in an era of unprecedented progress against cancer,
including advances in immunotherapies and targeted anti-cancer
therapies that led to spectacular decreases in cancer mortality. Thanks
to investments at the NCI, we have new tools at our disposal that could
only be dreamed of decades ago to maximize advances in early diagnosis
of many types of cancer and offer highly effective treatments that
improve health outcomes and reduce health disparities. Additionally,
the funding that NCI provides to the NCI-designated cancer centers that
are located all throughout the country is supporting pioneering new
research, serving patients in their communities, and training the next
generation of cancer scientists.
There are so many breakthroughs within our grasp, but to achieve
them, we need federal investments to keep up with demand on basic
research for cancer.
Since FY 2015, thanks to your leadership, NIH funding has increased
by nearly 42%. But due to other funding needs at NIH, including worthy
initiatives that take away from the top line, and a nearly 50% increase
in applications at NCI since 2013, the funding increases have not kept
up with demand.
Even with the significant funding you have provided, the percent of
NCI grant applications that are funded, referred to as the success
rate, is among the lowest of all institutes at NIH. In FY 2020, the
NIH-wide success rate for competing research project grants, or RPGs,
was nearly 21%. For NCI, it was only 12.8%, and that's the highest
NCI's success rate has been in six years.
NCI has been stretching dollars to fund more grants. NCI Director,
Dr. Sharpless, released his 15-by-25 milestone, an effort to increase
the number of R01 grants funded until it reaches the 15th percentile in
2025. The AACR strongly supports this important mission, but to achieve
the goal of funding more meritorious research, more funding will be
needed.
While the success rate of an RPG at NHLBI is 22.2%, and NIDDK is
23%, NIAID is 23.9%, and the National Institute on Aging is 25.8%,
NCI's rate of 12.8% is not sustainable to meet our pledge to apply new
cancer science and medicine towards improving patient outcomes. With
the low success rate, I worry the best and the brightest, in particular
early-stage researchers, will choose other career paths. The United
States cannot lead the world in cancer discoveries if the NCI success
rate is so low that researchers choose another field.
Thanks to your leadership, language was included in the last two
explanatory statements to prioritize competing grants and sustain
commitments to continuing grants. I humbly ask you to continue these
efforts in FY 2022 and provide funding to meet Dr. Sharpless' goal so
the cancer research community can accelerate the path to discoveries
and save lives.
I know cancer is personal for you, as it is for me. Thank you for
this opportunity and for your commitment to bringing us closer to our
mutual goal of conquering cancer.
[This statement was submitted by David A. Tuveson, MD, PhD, FAACR,
President, American Association for Cancer Research.]
______
Prepared Statement of the American Association for Clinical Chemistry
The American Association for Clinical Chemistry (AACC) welcomes the
opportunity to provide testimony to the Senate Appropriations
Subcommittee on Labor, Health & Human Services, and Education regarding
our nation's fiscal year (FY) 2022 budget priorities. AACC and its
partners are urging the subcommittee to support two initiatives vital
to improving the quality and efficacy of healthcare in the United
States:
--Improving Pediatric Reference Intervals--$10 million for the
Centers for Disease Control and Prevention, Division of
Laboratory Services, Environmental Health Laboratory to improve
the quality of pediatric reference intervals used by health
practitioners to diagnose, monitor, and treat children.
--Harmonizing Clinical Laboratory Test Results--an additional $7.2
million ($9.2 million in total) for the Centers for Disease
Control and Prevention, Division of Laboratory Services,
Environmental Health Laboratory to continue its ongoing efforts
to harmonize the reporting of clinical laboratory test results,
which is the vital to providing better, more consistent
healthcare in the United States.
improving pediatric reference intervals
AACC, the American Academy of Pediatrics, the Children's Hospitals
Association, and 30 other organizations have written to the
subcommittee urging additional funding for the Centers for Disease
Control and Prevention (CDC) to improve the quality of pediatric
reference intervals (PRIs)--the range of numeric values expected in a
healthy child--available to health practitioners to care for their
young patients.
When making a diagnosis, the healthcare professional considers a
laboratory test value within the context of a reference interval. If
the test result falls outside of the defined reference interval for a
healthy child--either higher or lower--the practitioner may order a
medical intervention to address a health condition or change an ongoing
treatment protocol. If the diagnosis or treatment change is incorrect
for any reason, including an inaccurate reference interval, it could
result in patient harm. Therefore, it is critical that the range of
values used by practitioners to interpret test results are accurate.
Whereas the reference intervals for adults are generally reliable,
there is considerable inconsistency and large gaps in the ranges
available for children. Healthcare practitioners need reference
intervals reflective of healthy children at each unique stage of
physical development from birth through adolescence to adulthood. In
addition, the intervals must also take into consideration any
variations due to biological factors, such as ethnicity and gender.
Accurate and actionable PRIs are particularly important for our
youngest patients, who are often unable to verbally communicate their
symptoms. Unfortunately, most laboratories are unable to obtain enough
samples from a diverse, healthy population of children to develop their
own reference intervals.
Congress recognized the importance of this issue when in the
accompanying report language to the Further Consolidated Appropriations
Act of 2020 it requested CDC to develop and submit a plan for improving
PRIs. The agency outlined its plan in the Department of Health and
Human Services fiscal year 2021 congressional justification to
Congress. The plan calls for the CDC to employ its existing
infrastructure to initiate and advance this vital work. According to
CDC, it can:
--collect clinical samples through its National Health and Nutrition
Examination Survey (NHANES), which has the organization and
expertise to collect specimens from healthy children; and
--utilize its Environmental Health Laboratory (EHL) to generate the
reference intervals for children and disseminate the
information to clinical laboratories. EHL has developed
reference intervals in the past.
AACC and its partners support providing CDC with an additional $10
million to improve the quality of PRIs critical to caring for our
nation's children.
harmonizing clinical laboratory test results
Another issue that AACC and its allies request your assistance with
is the harmonization of clinical laboratory test results. Laboratory
test methods provide accurate test results, but different methods
generate different numeric values. With different methods in use across
the healthcare system, lack of harmonization makes it difficult to
develop widely applicable clinical guidelines or performance measures.
It also complicates data aggregation, which limits the development of
tools to better inform health decision-making.
Tests that are harmonized (or standardized) provide the same
numeric value for a condition regardless of the method or instrument
used or the setting where the tests are performed. An early example of
harmonization is cholesterol, which is widely utilized by the medical
community to diagnose heart disease. A 2011 study published in
Preventing Chronic Disease reports that early drug intervention based
on cholesterol levels saved the health system $338 million to $7.6
billion annually between 1980--2000.\1\ Harmonization can improve
patient care while also saving money.
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\1\ Hoerger TJ, Wittenborn JS, Young W. A cost-benefit analysis of
lipid standardization in the United States. Preventing Chronic Disease
2011; 8: A136.
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In recent years, Congress has supported the expansion of CDC's
harmonization efforts, resulting in new activities to improve the
detection and management of hormone disorders, kidney disease, cancer,
and heart disease. With additional funding, the agency will be able to
expand its harmonization activities to develop materials for non-
traditional biomarkers, such as apolipoproteins, and the assessment of
point of care testing devices that are increasingly being used by
healthcare providers and patients.
AACC and its partners respectfully request that the subcommittee
provide an additional $7.2 million ($9.2 million in total) for the CDC
to continue and advance its harmonization activities. Congress has
provided $2 million annually for this program since FY18.
AACC is a global scientific and medical professional organization
dedicated to clinical laboratory science and its application to
healthcare. We look forward to working with the subcommittee on these
most important issues as it goes through the FY22 budget process. If
you have any questions, please email Vince Stine, PhD, AACC's Senior
Director of Government and Global Affairs, at [email protected].
[This statement was submitted by David Grenache, PhD, D(ABCC),
President, American Association for Clinical Chemistry.]
______
Prepared Statement of the American Association for Dental Research
On behalf of the American Association for Dental Research (AADR), I
am pleased to submit testimony describing AADR's funding requests for
fiscal year (FY) 2022. I currently serve as the chair of the Board of
Directors and president of the Association. I am a professor in the
Department of Diagnostic and Biological Sciences at the University of
Minnesota School of Dentistry, where I also serve as the director
emeritus of the Minnesota Craniofacial Research Training Program
(MinnCResT).
For FY 2022, the American Association for Dental Research--along
with our colleagues in the oral health community--is seeking at least
$520 million for the National Institute of Dental and Craniofacial
Research (NIDCR) and at least $46.111 billion for all of the Institutes
and Centers at the National Institutes of Health (NIH). Funding at
these recommended levels will allow for the entities' base budgets to
keep pace with the biomedical research and development price index
(BRDPI) and provide meaningful growth of 5%.
As our nation continues to respond to the global COVID-19 pandemic,
we are reminded of the importance of the federal investment in science,
and in particular, biomedical research. AADR is grateful to Congress
for consistently prioritizing this research at NIH by providing steady
and meaningful funding increases, which will be more important than
ever to carry forward in the wake of the pandemic. While we recognize
there will be funding challenges in FY 2022 given the tremendous
resources allocated to COVID-19 relief, we cannot afford to underfund
our nation's research agencies now. Underfunding will leave us ill-
equipped to complete our exit from the current pandemic, deal with
future pandemics, and risk losing the progress that has been made by
congressional investment in biomedical research.
The requested 5% growth above BRDPI would provide critical support
for these research agencies, which have been among the many enterprises
negatively impacted by this public health crisis. The ongoing pandemic
caused closures of university campuses and forced laboratories to scale
back or halt research projects. It also required research agencies to
shift existing resources and funding to coronavirus-related research at
the expense of other important scientific inquiries about health and
disease.
NIDCR--the largest institution dedicated exclusively to research to
improve dental, oral and craniofacial (skull and face) health--is one
the NIH Institutes and Centers that has prioritized COVID-19 research.
To date, NIDCR has funded approximately $3.9 million of immediate and
high impact research to protect and ensure the safety of personnel and
patients in dental practices during the COVID-19 pandemic. The
Institute will soon release a second round of funding related to COVID-
19.\1\ Funding for NIDCR COVID-19 research is critical to the nation's
public health, supporting work that includes the use of personal
protective equipment (PPE) in dental settings, aerosol and droplet
transmission in dental settings, the infection of salivary glands and
oral tissues by SARS-CoV-,\2\ and the use of biosensors to detect SARS-
CoV-2 in saliva.
This important research agenda with broad public health impact
notwithstanding, NIDCR was not included among the NIH Institutes and
Centers to receive targeted supplemental funding in COVID-19 relief
legislation--nor has the annual investment in NIDCR kept pace with the
overall funding increases provided to NIH over the past several years.
Funding of at least $520 million in FY 2022 would help bring NIDCR
funding into alignment with the overall NIH request and allow NIDCR to
build on its myriad successes in its mission to improve dental, oral
and craniofacial health.
Oral health--too often considered in isolation--is integral to
overall health. The research being conducted at, and supported by,
NIDCR impacts the lives of millions of Americans. Oral health can
affect activities that may be taken for granted: the ability to eat,
drink, swallow, smile, speak, and maintain proper nutrition. The oral
cavity also serves as a window into potential health issues, including
but not limited to systemic diseases, such as diabetes, HIV/AIDS and
Sjogren's, an autoimmune disease that causes one's immune system to
attack parts of its own body.
Coronavirus research shows that the virus can infect more than the
upper airways and lungs, but also cells in other parts of the body. In
fact, recent NIDCR-supported research has also shown that the novel
coronavirus can infect cells in the mouth. As the study's authors
explain.\2\ :
``The potential of the virus to infect multiple areas of the body
might help explain the wide-ranging symptoms experienced by COVID-19
patients, including oral symptoms such as taste loss, dry mouth and
blistering. Moreover, the findings point to the possibility that the
mouth plays a role in transmitting SARS-CoV-2 to the lungs or digestive
system via saliva laden with virus from infected oral cells.''
According to NIDCR's press release on the study, this research is
contributing to our understanding of COVID-19, including oral
transmission, and could inform interventions to help combat the virus
and alleviate the associated oral symptoms. Indeed, this seminal
research may have important implications to explain why super-spreader
events occur in places where people sing, speak loudly, or party.
Dental, oral and craniofacial research presents vast research
opportunities, and we know NIDCR will continue to be the key player in
advancing our understanding of the role of the mouth and oral tissues
in many scientific frontiers going forward. One path to highlighting
the Institute's work and the future of this research in the United
States is through the U.S. Surgeon General's Report on Oral Health, a
critical update to the seminal ``Oral Health in America'' report from
July 2000. The report--originally set to be released in the fall of
2020--will document the progress in the improvement of oral health
since 2000, provide insight into issues currently affecting oral
health, and identify opportunities and challenges that have emerged
over the past 20 years. The 2000 report shifted perspectives among the
public and policymakers by showing that oral health goes beyond healthy
teeth and gums and that it is essential to our general health and well-
being. We believe the 2020 report will also have a significant impact,
and we have encouraged the administration to swiftly review and release
the report. The long-awaited report is a critical public health
document and is essential to moving our nation's health forward.
In addition to the important work of NIDCR, AADR recognizes that
federal research and public health efforts work in concert and that
success in one area can benefit another. Therefore, we encourage
Congress--in addition to supporting NIH and NIDCR in FY 2022, to
support the full breadth of federal agencies supporting oral health.
Complementing our NIDCR and NIH requests, we urge you to provide $30
million for the CDC's Division of Oral Health, $46 million for the
Title VII Health Resources and Services Administration (HRSA) programs
that train the dental health workforce, at least $500 million for the
Agency for Healthcare Research and Quality (AHRQ), and at least $200
million for the National Center for Health Statistics (NCHS).
The COVID-19 crisis shook our nation and reminded us of the
critical role biomedical and public health research play in our
society. Over the course of 2020 and 2021, we saw how the research
enterprise can safeguard public health, national security and economic
growth. We urge Congress to continue to prioritize biomedical research,
including dental, oral and craniofacial research in FY 2022 so our
nation's citizens can continue to enjoy the benefits of state-of-the-
art, world-leading health care.
We appreciate the opportunity to submit this testimony and thank
the Subcommittee for considering our request of at least $520 million
in funding for NICDR and at least $46.111 billion for the Institutes
and Centers at NIH. AADR stands ready to assist the Congress in any way
we can and to answer any questions you may have.
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\1\ National Advisory Dental and Craniofacial Research Council--
January 2021. National Institutes of Health, 2021. https://
videocast.nih.gov/watch=38984.
\2\ Scientists Find Evidence that Novel Coronavirus Infects the
Mouth's Cells. Press Release, NIDCR. https://www.nidcr.nih.gov/news-
events/nidcr-news/2021/scientists-find-evidence-novel-coronavirus-
infects-mouths-cells; Huang, N., Perez, P., Kato, T. et al. SARS-CoV-2
infection of the oral cavity and saliva. Nat Med 27, 892-903 (2021).
https://doi.org/10.1038/s41591-021-01296-8.
[This statement was submitted by Mark C. Herzberg, D.D.S., Ph.D.,
President, American Association for Dental Research.]
______
Prepared Statement of the American Association of Colleges of Nursing
strengthening the current and future nursing workforce
On behalf of the American Association of Colleges of Nursing
(AACN), we want to thank the Subcommittee for its leadership and
continued support of nursing education, the nursing profession, and
nursing research, especially during this unprecedented time. As the
national voice for academic nursing, AACN represents nearly 840 schools
of nursing at private and public universities, who educate more than
580,000 students and employ more than 52,000 faculty.\1\ Collectively,
these institutions play a critical role in protecting the health of our
nation by graduating registered nurses (RN), advanced practice
registered nurses (APRN), educators, researchers, and other frontline
providers. As we work to combat current public health challenges, such
as COVID-19, and prepare for the future, ensuring a robust supply of
nursing professionals requires a strong and sustained federal
investment. For Fiscal Year (FY) 2022, AACN respectfully requests that
you provide bold support of at least $530 million for the Nursing
Workforce Development Programs (Title VIII of the Public Health Service
Act [42 U.S.C. 296 et seq.] administered by HRSA and at least $199.755
million for the National Institute of Nursing Research (NINR), which
was included in the President's FY 2022 Budget.
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\1\ American Association of Colleges of Nursing. (2021) Who We Are.
Retrieved from: https://www.aacnnursing.org/About-AACN/Who-We-Are.
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the growing nursing workforce demand
Nurses comprise the largest sector of the healthcare workforce with
more than four million RNs and APRNs, which include Nurse Practitioners
(NPs), Certified Registered Nurse Anesthetists (CRNAs), Certified
Nurse-Midwives (CNMs), and Clinical Nurse Specialists (CNSs).\2\ Nurse
educators, students, and practitioners are leaders within their
institutions and communities; many of whom are also serving on the
frontlines of the COVID-19 public health emergency. Even prior to
COVID-19, our nation was in need of additional nurses. This demand is
only expected to grow as we continue to combat the pandemic and address
the healthcare needs of all patients, including those in rural and
underserved areas. In fact, the Bureau of Labor Statistics' outlook for
RN workforce demand projected an increase of 7% by 2029, representing
the need for an additional 221,900 jobs.\3\ Additionally, the need for
most APRNs is expected to grow by 45%.\4\ This increasing demand in the
nursing workforce can be attributed to several factors such as an aging
population, nursing retirements, and an increase in workplace
stress.\5\ Bold investments in Title VIII Nursing Workforce Development
Programs and NINR would help prepare a highly educated nursing
workforce and strengthen the foundation of nursing science, not only as
we confront existing health challenges, but as we provide tomorrow's
equitable and innovative healthcare solutions.
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\2\ National Council of State Boards of Nursing. (2021). Active RN
Licenses: A profile of nursing licensure in the U.S. as of April 23,
2021. Retrieved from: https://www.ncsbn.org/6161.htm.
\3\ U.S. Bureau of Labor Statistics. (2021). Occupational Outlook
Handbook-Registered Nurses. Retrieved from: https://www.bls.gov/ooh/
healthcare/registered-nurses.htm.
\4\ U.S. Bureau of Labor Statistics. (2021). Occupational Outlook
Handbook-Nurse Anesthetists, Nurse Midwives, and Nurse Practitioners.
Retrieved from: https://www.bls.gov/ooh/healthcare/nurse-anesthetists-
nurse-midwives-and-nurse-practitioners.htm.
\5\ American Association of Colleges of Nursing. (2020) Fact Sheet:
Nursing Shortage. Retrieved from: https://www.aacnnursing.org/Portals/
42/News/Factsheets/Nursing-Shortage-Factsheet.pdf.
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nursing workforce investments: sustaining education to secure a strong
nursing workforce
Our ongoing efforts to combat COVID-19 have made it abundantly
clear that a well-educated nursing workforce is essential. For over
fifty years, Title VIII Nursing Workforce Development Programs have
been a catalyst for strengthening nursing education at all levels, from
entry-level preparation through graduate study. Through grants,
scholarships, and loan repayment programs, Title VIII federal
investments positively impact the profession's ability to serve
America's patients in all areas, bolster diversity within the
workforce, and increase the number of nurses, including those at the
forefront of public health emergencies and caring for our aging
population.
Each Title VIII Nursing Workforce Development Program provides a
unique and crucial mission to support nursing education and the
profession. For example, the Advanced Nursing Education (ANE) programs
help increase the number of APRNs in the primary care workforce and
supported more than 8,200 students in Academic Year 2019-2020 alone.\6\
In addition, the Nurse Faculty Loan Program (NFLP) awarded 45 grants to
schools that supported 2,270 graduate nursing students in Academic Year
2019-2020.\7\ According to AACN's Annual Survey, student enrollment in
entry-level baccalaureate nursing programs increased by 5.6% in
2020.\8\ While this heightened interest in nursing education is
promising news, we need to ensure these students have ample nursing
faculty to guide them through their clinical and didactic education and
prepare them to respond to our nation's ever-changing healthcare
environment.
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\6\ Department of Health and Human Services Fiscal Year 2022 Health
Resources and Services Administration Justification of Estimates for
Appropriations Committees. Pages 153-155. Retrieved from: https://
www.hrsa.gov/sites/default/files/hrsa/about/budget/budget-
justification-fy2022.pdf.
\7\ Department of Health and Human Services Fiscal Year 2022 Health
Resources and Services Administration Justification of Estimates for
Appropriations Committees. Page 167. Retrieved from: https://
www.hrsa.gov/sites/default/files/hrsa/about/budget/budget-
justification-fy2022.pdf.
\8\ American Association of Colleges of Nursing. (2021). Student
Enrollment Surged in U.S. Schools of Nursing in 2020 Despite Challenges
Presented by the Pandemic. Retrieved from https://www.aacnnursing.org/
News-Information/Press-Releases/View/ArticleId/24802/2020-survey-data-
student-enrollment%20%20%20%20%20.
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As we address social determinants of health and work to build an
equitable healthcare system for all patients, it is imperative that we
recruit individuals from diverse backgrounds to the nursing profession.
Increasing diversity in the profession will not only create lifelong
career pathways, but will also improve care quality and access to
population-centered care. The Nursing Workforce Diversity (NWD) program
serves as a glowing example of a successful Title VIII initiative that
accomplishes this goal. In fact, in Academic Year 2019-2020, the NWD
program awarded grants supporting 11,620 nursing students from
disadvantaged backgrounds.\9\ The recruitment of underrepresented
racial and ethnic individuals and those from economically diverse
backgrounds to nursing positively impacts the classroom, professional
practice environments, and ultimately patients.
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\9\ Department of Health and Human Services Fiscal Year 2022 Health
Resources and Services Administration Justification of Estimates for
Appropriations Committees. Page 159. Retrieved from: https://
www.hrsa.gov/sites/default/files/hrsa/about/budget/budget-
justification-fy2022.pdf.
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As such, to ensure the stability of our nursing workforce now and
in the future, we request at least $530 million for Title VIII Nursing
Workforce Programs.
from research to reality: nursing science protects americans' health
AACN recognizes how scientific research and discovery is the
foundation on which nursing practice is built and is essential to
advancing evidence-based interventions, informing policy, and
sustaining the health of the nation. As one of the 27 Institutes and
Centers at NIH, NINR plays a fundamental role in improving care and is
on the cutting edge of new innovations impacting how nurses are
educated and how they practice. In fact, 80% of research-focused
educational training grants at nursing schools are funded by NINR.\10\
Through these grants and others, nurse scientists, often working
collaboratively with other health professionals, are generating and
translating impactful new research in areas such as big data and data
science, precision health, and genomics.\11\ Despite the critical
research these grants support, NINR was only able to fund 8.9% of grant
applications in 2017, due to insufficient funding.\12\ This is the
lowest research project grant (RPG) success rate among all NIH
institutes and centers, and is significantly lower than the overall NIH
RPG success rate of 18.7%.\13\ To further this vital work, we are
requesting a total of at least $199.755 million for the National
Institute of Nursing Research.
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\10\ Schnall, R. (2020) National Institute of Health (NIH) funding
patterns in Schools of Nursing: Who is funding nursing science research
and who is conducting research at Schools of Nursing? Journal of
Professional Nursing, 36(1), 34-41. Retrieved from https://
www.sciencedirect.com/science/article/pii/S8755722319301164?via=ihub#.
\11\ National Institutes of Health, National Institute of Nursing
Research. The NINR Strategic Plan: Advancing Science, Improving Lives.
Retrieved from: https://www.ninr.nih.gov/sites/www.ninr.nih.gov/files/
NINR_StratPlan2016_reduced.pdf.
\12\ Federal Funding of Nursing Research by the National Institutes
of Health (NIH): 1993-2017 Kiely, Daniel P. et al. (2019) Page 9.
Retrieved from: https://www.nursingoutlook.org/article/S0029-
6554(19)30315-X/addons.
\13\ Ibid.
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From the classroom to the frontlines, nurses and nursing students
are integral members of the healthcare team. Strong investments in
Title VIII Nursing Workforce Development Programs and NINR have a
direct impact on sustaining pathways into nursing and patient access to
high-quality, evidence-based care in all communities across the nation.
During these unprecedented times, AACN respectfully requests bold
support in FY 2022 of at least $530 million for the Title VIII Nursing
Workforce Development Programs and at least $199.755 million for the
National Institute of Nursing Research. Together, we can ensure that
such investments promote innovation and improve health and healthcare
in America.
[This statement was submitted by Susan Bakewell-Sachs, PhD, RN,
FAAN, Board Chair, American Association of Colleges of Nursing.]
______
Prepared Statement of the American Association of Colleges of
Osteopathic Medicine
The American Association of Colleges of Osteopathic Medicine
(AACOM) strongly supports fiscal year (FY) 2022 funding for the
following programs important to the osteopathic medical education (OME)
community:
--$46.1 billion for the National Institutes of Health (NIH)
--$6.1 billion for the Teaching Health Centers Graduate Medical
Education (THCGME) Program
--$9.2 billion for discretionary Health Resources and Services
Administration (HRSA)
--$980 million for the Title VII health professions workforce
development programs under the Public Health Service Act
--Permanent funding for the Rural Residency Planning and Development
(RRPD) Program
--$130 million for discretionary National Health Service Corps (NHSC)
Scholarship and Loan Repayment programs
--$67 million for the Area Health Education Center (AHEC) Program
--$125 million for the Primary Care Training and Enhancement (PCTE)
Program
--$500 million for the Agency for Healthcare Research and Quality
(AHRQ)
--$10 billion for the Centers for Disease Control and Prevention
(CDC)
AACOM leads and advocates for the full continuum of OME to improve
the health of the public. Founded in 1898 to support and assist the
nation's osteopathic medical schools, AACOM represents all 37
accredited colleges of osteopathic medicine--educating nearly 31,000
future physicians, 25 percent of all U.S. medical students--at 58
teaching locations in 33 U.S. states, as well as osteopathic graduate
medical education professionals and trainees at U.S. medical centers,
hospitals, clinics, and health systems.
Osteopathic medicine plays an essential role in our nation's
healthcare delivery system and is a growing field. According to recent
data, AACOM received more than 28,000 applicants to osteopathic medical
school for the 2020-2021 application cycle, representing a 19.26
percent increase over the previous year. Osteopathic physicians focus
on treating the whole person, and over half practice in the primary
care specialties of family medicine, internal medicine, and pediatrics.
Importantly, osteopathic medical students receive 200 hours of
additional training in osteopathic manipulative treatment, a hands-on
treatment used to diagnose and treat illness and injury, giving us a
unique voice and perspective in the medical community. However, the
clinician workforce and scientists at osteopathic medical schools are
underutilized in NIH funding opportunities and underrepresented on NIH
Advisory Councils and standing study sections.
AACOM urges Congress to overcome the historic bias against
osteopathic medical research by expanding representation on NIH
Councils and study sections and increasing NIH funding. Expanding
engagement by osteopathic medical schools and professionals will result
in innovative healthcare delivery solutions, expanded evidence-based
research, and broader community-focused treatment models. OME
investment will advance research in primary care, prevention, and
treatment and employ an already diverse physician population that is
enriched in socioeconomically disadvantaged rural communities. AACOM's
request of $46.1 billion for NIH will support scientific advancements
that incorporate the osteopathic philosophy and strengthen the United
States position as the world's research and development leader.
OME has a proven history of establishing educational programs for
medical students and residents that target the healthcare needs of
rural and underserved populations. With health disparities on the rise,
and worsening because of the COVID-19 pandemic, we are proud to help
make healthcare access more equitable for all our country's patients
and communities. In fact, recent AACOM data show that 40 percent of
graduating 2019-2020 osteopathic medical students plan to practice in a
medically underserved or health shortage area; of those, 45 percent
plan to practice in a rural community.
AACOM expresses its strong support for $6.1 billion for the THCGME
Program and our desire for permanent, mandatory funding for this
critical program. According to HRSA, physicians who train in Teaching
Health Centers (THCs) are three times more likely to work in such
centers and more than twice as likely to work in underserved areas. The
continuation of this program is critical to addressing primary care
physician workforce shortages and delivering health care services to
underserved communities. AACOM is pleased that Congress supported this
highly successful bipartisan program through the Consolidated
Appropriations Act, 2021 and American Rescue Plan Act of 2021, which
extended the THCGME Program through fiscal year 2023 and provided
additional funding. However, new funding is needed to extend the THCGME
Program to meet economic challenges caused by the COVID-19 pandemic and
support additional expansion to underserved areas that face existing
shortages of primary care physicians.
AACOM appreciates the opportunity to submit its views and looks
forward to continuing to work with the Subcommittee on these important
matters.
[This statement was submitted by Robert A. Cain, DO, FACOI, FAODME,
President and Chief Executive Officer, American Association of Colleges
of
Osteopathic Medicine.]
______
Prepared Statement of the American Association of Immunologists
The American Association of Immunologists (AAI), the nation's
largest professional association of research scientists and physicians
who are dedicated to understanding the immune system through basic,
translational, and clinical research, respectfully submits this
testimony regarding fiscal year (FY) 2022 appropriations for the
National Institutes of Health (NIH). AAI recommends an appropriation of
$52 billion for NIH for FY 2022, including at least $46.1 billion for
the regular NIH budget, to enable the agency to fund needed research to
prevent dangerous infectious diseases and treat debilitating chronic
illnesses, support meritorious scientists at all career stages, and
ensure a robust research enterprise that maintains U.S. preeminence in
biomedical science and innovation. Because the COVID-19 pandemic has
posed difficult challenges, including lab closures and other
interruptions, to many biomedical (particularly early career)
scientists, NIH needs, and AAI strongly supports, an infusion of
additional funding that would likely be considered outside of the
annual appropriations process.
AAI also supports the appropriation of substantial funding to
launch the newly proposed Advanced Research Projects Agency for Health
(ARPA-H). While AAI is enthusiastic about ARPA-H's potential, we
believe that any funding provided must supplement, and not supplant,
the NIH regular budget, and that this new agency must enhance, and not
interfere with, NIH's historic commitment to funding basic research.
AAI also urges that NIH solicit stakeholder input to help answer many
outstanding questions, including whether existing programs--and which
research areas--will be integrated into ARPA-H. Finally, AAI believes
that funding for ARPA-H projects should be provided for longer than
three years to ensure sufficient time for the kind of innovative,
collaborative, and transformative research that is contemplated.
illustrating the importance of understanding the immune system: covid-
19
The COVID-19 pandemic has highlighted both the importance, and high
stakes, of biomedical research. Our lives, health, security, and
prosperity depend on scientific understanding and advances. What felt
remote to many people--scientists toiling away unseen in their
laboratories--has become urgent, everyday news. The surge of interest
in immunology--and scientists' ability to meet this historic moment--
have been bright spots in an otherwise tragic, painful, and
unprecedented year, and rapidly developed vaccines to prevent COVID-19
infection have been a historic success story.
But SARS-CoV-2, the virus that causes COVID-19, continues to
mutate, giving rise to new variants. We know that this is what viruses
do, and we know that this is what our immune systems must be primed to
fight. Despite excellent news on the vaccine front, the regular
appearance of new variants, our paucity of therapeutics for those who
contract COVID-19, and our lack of understanding of, and treatments
for, Post-Acute Sequelae of SARS-CoV-2 infection (PASC, or ``long
COVID'') all render as premature any declaration of victory. We must
continue to invest robustly not only in a deeper understanding of how
the immune system responds to this virus and these vaccines, but also
in research devoted to the basic understanding of the immune system.
Such research will help us both emerge from this pandemic and prevent--
and more rapidly extinguish--any future ones.
But the study of immunology is about much more than infectious
diseases. Research on the immune system has taught us how to harness it
to kill malignant tumors and treat other chronic diseases
(immunotherapy); how it prevents or exacerbates chronic conditions such
as Alzheimer's, multiple sclerosis, and cardio-vascular disease; how it
enables--or prevents--the successful transplantation of a lifesaving
organ; and how it can protect its host from (natural or man-made)
agents of bioterrorism.
how basic immunology research led to rapid approval of vaccines and
treatments for covid-19
In this pandemic era, there is no better way to illustrate the
importance of a long-term commitment to biomedical research, and
specifically to immunological research, than to describe how science
achieved the near-impossible: the successful testing, manufacture, and
distribution of multiple, highly effective, and safe vaccines against
COVID-19 in less than a year after the identification of the causative
agent. The development of both treatments and vaccines for SARS-CoV-2
infection and COVID-19 was a result of decades of basic research, much
of which was funded by, or performed at, NIH. This work includes
understanding the virus, identifying good antigens for a vaccine, and
defining immune system responses to infection.
SARS-CoV-2 is a member of the beta-coronavirus family responsible
for two other recent outbreaks, SARS-CoV-1 (2003) and MERS (2012) and
is related to the coronaviruses that cause 15-30% of common colds. More
than 50 years of research on this virus family has allowed us to
understand key portions of the viral genome and viral life cycle, as
well as the importance of the spike protein for infection. While work
at NIH's National Institute of Allergy and Infectious Diseases' Vaccine
Research Center identified how to manipulate the spike protein so it
could be used in a vaccine, work on other infectious diseases and some
cancers facilitated the implementation of the mRNA platform into a
ready-to-use state. After developing mRNA vaccines for 10-15 years,
scientists launched some of the first clinical trials using the mRNA
platform against Zika virus and influenza. As a result, the platform
was ready to be quickly adapted to target the SARS-CoV-2 spike protein.
In other work, scientists rapidly characterized immune responses in
people who experienced SARS-CoV-2 infection. Patients with poor
outcomes had over exuberant immune responses; blocking these responses
with steroids improved survival. Immunologists also identified several
immune molecules that are at too high levels (e.g., IL-6) or too low
levels (e.g., interferon). Work is ongoing to understand what
protective immunity looks like, including the types of antibodies and
cellular immunity that prevent reinfection and characterize immunity
after vaccination. These studies will support the generation of booster
vaccines and give us insight into how well current vaccines protect
against new viral variants.
Finally, because of this longstanding research into coronaviruses,
scientists can reasonably infer how long protective immunity will last
following infection with, or vaccination against, SARS-CoV-2, giving
the public confidence to resume their daily activities while providing
the scientific community with a needed window in which to develop
booster vaccines that will protect against circulating viral variants.
vaccines against other infectious diseases and newly emerging threats
Vaccines remain the most effective method of disease prevention.
Vaccination against more than two dozen viral, bacterial, and fungal
diseases prevents about 2.5 million deaths globally and reduces the
severity of illness for millions of people annually.\1\ As the world's
population grows and as travel enables people to become even more
interconnected, we will continue to experience the very real threat of
new emerging pathogens causing a deadly pandemic. Lessons we learn from
developing and administering vaccines against SARS-CoV-2 will be
essential to protecting against other infectious diseases and a future
pandemic.
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\1\ https://www.who.int/immunization/global_vaccine_action_plan/
GVAP_doc_2011_2020/en/.
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Last year, I testified that there was no approved vaccine against
SARS-CoV-2, but that NIH-funded research conducted on other causative
pathogens in recent epidemics, including SARS and MERS, had made
possible the rapid development of vaccine candidates against SARS-CoV-
2.\2\ Since then, three vaccine candidates have received an Emergency
Use Authorization (EUA) from the Food and Drug Administration (FDA),
and two will be considered soon for licensure.\3\ AAI is confident that
previously conducted research, together with new research now being
urgently pursued, will result in additional vaccines and treatments to
prevent and/or reduce both the lethality of, and long-term symptoms
caused by, COVID-19.
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\2\ https://www.niaid.nih.gov/diseases-conditions/coronaviruses.
\3\ https://www.fda.gov/emergency-preparedness-and-response/
coronavirus-disease-2019-covid-19/covid-19-vaccines; https://
www.pfizer.com/news/press-release/press-release-detail/pfizer-and-
biontech-initiate-rolling-submission-biologics; https://
investors.modernatx.com/news-releases/news-release-details/moderna-
announces-initiation-rolling-submission-biologics.
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nih: the essential role of the nation's leading biomedical research
agency
As the nation's major funding agency for biomedical research, NIH
is an indispensable scientific leader both in the U.S. and around the
world. The steward of nearly $43 billion in federal funds, NIH
distributes more than 80% of its budget via a competitive peer review
process to more than 300,000 researchers at 2,500 universities,
medical schools, and other research institutions across the nation and
internationally.\4\ About 10% of its budget supports 6,000 additional
researchers and clinicians who work at NIH facilities around the
country.\5\ By funding these researchers and laboratories, NIH not only
advances scientific achievement, it also helps strengthen state and
local economies; in 2020, NIH funding supported more than 536,000 jobs
and accounted for $91 billion in economic activity across the U.S.\6\
The basic research that NIH funds is an essential and irreplaceable
part of the biomedical research pipeline; data show that it contributed
to all 210 of the new drugs approved by the FDA from 2010-2016.\7\
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\4\ https://www.nih.gov/about-nih/what-we-do/budget; https://
report.nih.gov/award/index.cfm.
\5\ https://irp.nih.gov/about-us/research-campus-locations.
\6\ https://www.unitedformedicalresearch.org/wp-content/uploads/
2021/03/NIHs-Role-in-Sustaining-the-U.S.-Economy-FINAL-3.23.21.pdf.
\7\ https://directorsblog.nih.gov/2018/02/27/basic-research-
building-a-firm-foundation-for-biomedicine/.
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NIH plays an essential role in responding to emerging health
threats; throughout the coronavirus pandemic, NIH leaders and
researchers have provided critically needed scientific advice to the
President, Congress, and the American public while also utilizing their
expertise to help develop a vaccine and treatments. NIH also regularly
apprises our nation's leaders about other scientific advancements and
research priorities, and its unparalleled peer review process fosters
the wise distribution of taxpayer dollars.
continued funding increases needed to rebuild and grow nih capacity
Leadership by this subcommittee has helped Congress provide
generous increases to the NIH budget over the last six years. Although
these increases have helped restore much of the purchasing power that
NIH lost after years of inadequate budgets and erosion from biomedical
research inflation, NIH's purchasing power remains below its 2003 peak
funding level. Meaningful budget growth will help close this gap and
allow NIH to invest not just in important research priorities across
its Institutes and Centers, but also in the research workforce. While
NIH should continue to support meritorious senior scientists, it is
urgent to ensure that we will have sufficient mid- and early career
scientists ready to take on increasingly complex scientific challenges.
We must provide NIH with the resources needed to provide a dynamic
research environment that allows for the training, development, and
support of our next generation of researchers, doctors, professors, and
inventors--and give them the confidence to pursue these careers.
conclusion
AAI greatly appreciates the subcommittee's strong support for NIH
and urges a budget for NIH of $52 billion for FY 2022. Within that, AAI
recommends an appropriation of at least $46.1 billion for the regular
NIH budget to help the agency grow its ability to invest in critically
important research, including vital immunologic research, support
meritorious scientists at all career stages, and help scientists
discover new ways to prevent, treat, and cure deadly and debilitating
diseases that afflict people in the U.S. and throughout the world. AAI
also urges a substantial appropriation to launch the new ARPA-H, which
could greatly advance human immunology at a time in our history when
pressing public health needs, and unprecedented scientific
opportunities, have converged.
[This statement was submitted by Ross M. Kedl, Ph.D., Chair of the
Committee on Public Affairs, American Association of Immunologists.]
______
Prepared Statement of the American Association of Neuromuscular &
Electrodiagnostic Medicine
fiscal year 2022 recommendations
_______________________________________________________________________
--Please continue to provide meaningful, annual funding increases for
healthcare fraud and abuse programs at the Centers for Medicare
and Medicaid Services (CMS) while allowing for flexibility and
innovation to address emerging challenges.
--Please continue to include timely recommendations in the Committee
Report accompanying the annual Labor-Health and Human Services-
Education (LHHS) Appropriations Bill encouraging CMS to take
substantive action to systematically address fraud, abuse, and
the quality of patient care in electrodiagnostic (EDX)
medicine.
--Please provide the National Institutes of Health (NIH) with $46.1
billion in discretionary funding, an increase of $3.2 billion
over FY 2021. Please also provide proportional increases for
various NIH Institutes and Centers, including the National
Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS), the National Institute of Allergy and Infectious
Diseases (NIAID), and the National Institute of Neurological
Disorders and Stroke (NINDS).
--Please support adequate funding to establish the new Advanced
Research Projects Agency for Health (ARPA-H) at NIH to
facilitate robust and swift scientific progress on a variety of
neuromuscular conditions.
_______________________________________________________________________
Chairwoman Murray, Ranking Member Blunt, and distinguished Members
of the Subcommittee, thank you for the opportunity to present the views
of the American Association of Neuromuscular & Electrodiagnostic
Medicine (AANEM) during the consideration of FY 2022 L-HHS
appropriations. First and foremost, thank you for the ongoing
investment in medical research and patient care programs. Please
continue this investment in FY 2022.
In regards to fraud and abuse, the challenges and opportunities
that I will review today are not unique to AANEM, but impact a variety
of medical professional societies and patient communities who rely on
proper EDX testing. My comments are provided in the interest of
spotlighting serious issues that continue to undermine patient care and
waste federal healthcare resources, while advancing policy tools to
efficiently and effectively address these issues. In this regard,
please consider the AANEM a resource moving forward. Thank you again
for this important opportunity.
about aanem
AANEM is a nonprofit membership association dedicated to the
advancement of neuromuscular, musculoskeletal, and EDX medicine. Our
members--primarily neurologists and physical medicine and
rehabilitation (PMR) physicians--are joined by allied health
professionals and PhD researchers working to improve the quality of
medical care provided to patients with muscle and nerve disorders.
Founded in 1953, AANEM currently has over 5,400 members across the
country. Our mission is to improve quality of patient care and advance
the science of neuromuscular (NM) diseases and EDX medicine by serving
physicians and allied health professionals who care for those with
muscle and nerve disorders. Our members are dedicated to diagnosing and
managing a variety of nerve and muscle disorders including, but not
limited to, amyotrophic lateral sclerosis, muscular dystrophies, and
neuropathies, as well as more common conditions, such as pinched nerves
and carpal tunnel syndrome.
about edx medicine
When functioning properly, nerves send electrical impulses to the
muscles to activate them. A nerve disorder means that signals are not
getting through like they should. A muscle disorder means that muscles
aren't responding to the signals correctly. To determine whether your
nerves and muscles are working properly, your doctor may recommend you
have EDX testing, which generally includes both a nerve conduction
study (NCS) and needle electromyography (EMG) testing. Other tests may
include imaging, genetic testing, biopsies, biochemical tests, and
strength testing. The results of these tests help your doctor diagnose
your condition and determine the best treatment.
NCS.--These studies evaluate how quickly and efficiently electrical
impulse move through the nervous system. While it may sound straight-
forward, proper testing requires sophisticated equipment, an
understanding of the patient's health history, and, most importantly,
the ability to design/perform the study and interpret the results.
EMG.--These tests evaluate muscles and nerves through the use of
electrodes under the skin. Since the procedure is invasive and highly
technical, it is considered to be the practice of medicine by the
American Medical Association, requiring training, study, and experience
to ensure patient safety and testing efficacy.
about edx fraud and abuse
In 2014, the HHS OIG published a report entitled, Questionable
Billing for Medicare Electrodiagnostic Tests, which found roughly $140
million in suspicious activity annually. But experience tells us that
this is just the tip of the iceberg. And the toll of patient suffering
and hardship as the result of fraudulent EDX testing is incalculable.
Unfortunately, since this report was released, the situation has
deteriorated rather than improved. Our members have anecdotally noted
an increase in fraud activity (both through solicitations and by re-
testing patients that were victims of improperly performed tests),
which appears to be supported by CMS utilization data. CMS revised the
EDX codes in 2013 which has actually made it harder to identify
systematic fraud and abuse in this area. Bad actors are aware of the
gaps in the current CMS regulatory and enforcement framework that
create unique blind spots for EDX testing, and this deficiency
continues to be exploited with many criminal endeavors operating in the
open for years as sham professional service providers (the small number
that are caught and convicted annually has not served as a deterrent).
To be clear, the victims continue to be the patients that are
improperly tested, subjected to a battery of studies, and over-billed,
with no intention of receiving an accurate diagnosis or who were never
in need of testing in the first place.
current opportunities
CMS, the FBI, and the HHS OIG have been doing tremendous work to
root out fraud and abuse in EDX medicine, but these dedicated public
servants are limited by the constraints of the current pay-and-chase
model. Additional resources for ongoing CMS efforts to address
healthcare fraud and abuse will facilitate incremental improvements and
further protect patients, but modernization is needed as well. Over
recent appropriations cycles, Congress has called on CMS to work with
the EDX community on innovative solutions that could better identify
bad actors conducting EDX testing or simply prevent payments for
improper studies before they are made. Please continue to work with CMS
through the FY 2022 appropriations process to recommend greater
community collaboration and to encourage meaningful and timely progress
in the area of EDX fraud and abuse.
statement of aanem member dr. vince tranchitella
New NCS codes became effective on January 1, 2013. The new codes
were developed as a direct response to fraudulent activity that
resulted in the exponentially increased billing for NCSs.
Unfortunately, the new NCS codes failed to have the desired effect. My
most recent case involved 56 EDX studies, all of which were performed
AFTER the NCS codes were changed in 2013, and every single one of the
reports were deemed so far below the standard of care that none of them
could be considered a reliable representation of the true medical
status of the patients who received those tests. Therefore, none of
those tests should have been billed or reimbursed.
recent examples from dr. peter grant
EDX fraud not only wastes healthcare dollars, but, more
importantly, the quality of patient care suffers severely. As an
example, a recent case in which I testified in Houston working for the
FBI and the US Attorney's Office, many patients' insurance companies
were being billed more than $30,000 for a study that should cost $800
to $1200. Of note, when a detailed review was performed, more than 85%
of the diagnoses arrived at with these fraudulent studies were
incorrect and unreliable. These inappropriate and inaccurate studies
did not help these patients in finding appropriate treatments or
solutions to their medical problems. In fact, they often sent the
patients down costly and ineffective paths of treatment. In this case
alone the perpetrators were convicted of EDX fraud totaling nearly $5
million.
As is invariably the case with mobile EDX laboratories, quality of
care suffers while costs skyrocket and the real losers are,
unfortunately, the patients. In a case I had in California, a 47 year
old man had a mobile EDX study done that cost him (and his insurance
company) more than $7,500 and told him his symptoms were from a
``pinched nerve in his leg''. When I performed the correct study
(charging about $750) I found his true diagnosis to be ALS (or Lou
Gehrig's disease).
[This statement was submitted by Peter A. Grant, MD, EDX, Fraud and
Abuse Consultant for FBI/OIG, American Association of Neuromuscular &
Electrodiagnostic Medicine.]
______
Prepared Statement of the American Association of University Professors
Dear esteemed Members of Congress:
The American Association of University Professors (AAUP) is the
oldest organization of its kind, representing faculty and graduate
employees in institutions of higher education. Since its founding in
1915, the AAUP has been an active and influential voice in higher
education. The AAUP defines and develops fundamental professional
values, standards, and procedures for higher education; advances the
rights of academics, particularly as those rights pertain to academic
freedom and shared governance; and promotes the interests of higher
education teaching and research.
On behalf of all faculty, and our chapters across hundreds of
institutions, we write to thank you for your historic investments in
higher education over the course of the past year. Across the country,
funding provided by the CARES Act and subsequent COVID-19 relief bills
have stopped the worst financial impacts from hitting our campus
communities. However, as appreciated as the unprecedented $135 billion
has been, faculty and staff have not shared in all the benefits, to the
detriment of the student experience. According to a survey we recently
ran of faculty senate chairs, 10 percent of institutions had laid off
tenured faculty and 28 percent had laid off contingent faculty in the
past year,\1\ despite the influx of federal funds that explicitly said
that they could be used to meet payroll budget gaps. Faculty working
conditions are student learning conditions. To us, it is clear that our
institutions need sustained, increased funding to invest more in the
people and infrastructure that make them run.
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\1\ https://www.aaup.org/report/survey-data-impact-pandemic-shared-
governance.
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We are pleased to see the historic levels of funding proposed in
the American Families Plan and the President's FY22 budget. This
funding makes meaningful progress towards our call for a New Deal for
higher education,\2\ which calls for free college, faculty and staff
job security, and student debt cancellation. These planks of our New
Deal platform will provide institutions the resources they need to
better foster innovation and ensure high quality instruction. Beyond
that, in a time of political division and heightened social tension,
open access to a college education might also help us strengthen civic
engagement and advance racial and economic justice. However, as
ambitious and appreciated as the President's proposals have been, in
some ways they fall short of what students need--and don't go far
enough to equitably fund our institutions.
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\2\ https://newdealforhighered.org/.
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The AAUP recommends that the Appropriations Committee prioritize
the following to better meet the needs of faculty and students:
1. Double the Pell Grant, the purchasing power of which has
fallen to less than a third of the annual cost of tuition at
the average public institution. More than a thousand
organizations have called on Congress to increase Pell Grant
funding dramatically, and that call seems more urgent than ever
given increased student need during the pandemic. Furthermore,
we strongly encourage you to maintain the Pell Grant reserve,
and not rescind it to fund other programs within the Labor-HHS-
Education budget.
2. Increase funding for programs that support students of color,
non-traditional students, and low-income students, such as but
not limited to Title III funds to minority serving
institutions, TRIO, SEOG, work study, and CCAMPIS. These
programs ought to see more generous funding to help close
equity gaps between non-traditional students and their peers,
and to begin to address historic underfunding that minority-
serving institutions have faced.
3. Increase funding to scientific research programs, which are a
significant source of funding to support graduate students in
their pursuit of knowledge and a degree. The cutting-edge
academic and scientific discoveries made by researchers at
American institutions makes our higher education system one of
the most respected in the world. Many of these discoveries lead
to robust partnerships with private industry that result in job
creation and economic growth. And, the scientific breakthroughs
of the past year make a clear case for increased funding for
broad and exploratory research.
4. Create a federal-state partnership to make college free, so
that any qualified student might pursue an associate's or
bachelor's degree at the institution of their choice. Congress
should also consider how to increase funding to private
institutions so that they too can offer reduced costs, such as
Title III programs and noting in report language that states
may use these funds for student grant aid to subsidize the cost
of attendance at private institutions in their home state.
5. As a condition of this new funding, it ought to protect
faculty and staff job security by setting a baseline of support
for workers. Gig work and the exploitation of contingent
faculty erodes the foundations of what makes American higher
education so respected internationally. Beyond supporting an
increase in the share of faculty on the tenure track, where
applicable, positions on college campuses should provide a
guarantee of good pay, continuity of employment, and parity in
wages and benefits between full and part time positions.
Institutions should work as much as possible to convert
existing short-term contracts with employees to longer-term or
tenure-track appointments.
6. Promote shared governance, by making clear in bill and report
language that federal funding to institutions and states in the
aftermath of the COVID-19 pandemic ought to maintain
instructional spending levels and faculty jobs, ahead of
administrative costs or debt financing. Furthermore, faculty
and staff must have meaningful input when administration seek
to cut costs in moments of financial uncertainty.
We would again like to thank you for your generous and historic
funding to meet the needs of students and institutions of higher
education during the pandemic. We look forward to working with you to
help our country recover from the pandemic, strengthen our communities
and civil society, and create thousands more good-paying jobs on campus
in the process.
[This statement was submitted by Kaitlyn Vitez, Government
Relations Officer, and John McNay, Government Relations Committee
Chair, American Association of University Professors.]
______
Prepared Statement of the American College of Cardiology
The American College of Cardiology (ACC) commends Congress for
boosting funding for the National Institutes of Health (NIH) and
Centers for Disease Control and Prevention (CDC) in FY21. To continue
this important progress in FY22 and beyond, and to adequately fund
public health and research infrastructure in response to the COVID-19
pandemic, ACC urges members of Congress to appropriate the following
funds toward agencies doing vital work in cardiovascular disease (CVD)
treatment and prevention: $3.963 billion for the National Heart Lung &
Blood Institute (NHLBI) to increase the NIH's purchasing power and
preserve U.S. leadership in research; $160 million toward the CDC's
Division for Heart Disease and Stroke Prevention to strengthen heart
disease prevention efforts at state and local levels, $10 million
toward CDC's Million Hearts to prevent 1 million heart attacks and
strokes, $46.7 million toward CDC's WISEWOMAN to help uninsured or
under-insured women prevent or control heart disease, $10 million
toward CDC congenital heart research to study its effects over the
patient's lifespan, and $310 million toward CDC's Office on Smoking and
Health to maintain the program's cost-effective tobacco control
efforts. ACC asks for the inclusion of report language promoting
valvular heart disease research at the NHLBI since clinical predictors
of patients at higher risk of sudden cardiac death are still lacking.
ACC envisions a world where innovation and knowledge optimize
cardiovascular care and outcomes. As the professional home for the
entire cardiovascular team, the mission of the College and its more
than 52,000 members is to transform cardiovascular care and improve
heart health. The ACC bestows credentials upon cardiovascular
professionals who meet stringent qualifications and leads in the
formation of health policy, standards and guidelines. The College also
provides professional medical education, disseminates cardiovascular
research through its world-renowned JACC Journals, operates national
registries to measure and improve care, and offers cardiovascular
accreditation to hospitals and institutions.
CVD, a class of diseases that includes diseased blood vessels,
structural problems, and blood clots, continues to be the leading cause
of death among men and women in the United States and is responsible
for 1 in every 4 deaths.\1\ More than 92 million Americans currently
suffer from some form of CVD--nearly one-third of the population--but
it remains one of the most underfunded deadly diseases, as the NIH only
invests 4 percent of its research dollars on heart research.\2\ The
heart disease death rate has continued to drop since the 1970s \3\ due
to scientific advances and improved heart medications and procedures--
but to meet the challenges of an aging population, rising obesity rates
and the long-term complications of COVID-19 and patients with heart
disease, the NIH must maintain its place at the forefront of medical
innovation for years to come. The NHLBI, the third-largest institute at
the NIH, conducts research related to heart, blood vessel, lung, and
blood diseases, generating drugs for lowering cholesterol, controlling
blood pressure, and dissolving blood clots. These biomedical
advancements have contributed to a 71 percent \4\ decrease in death
rates due to cardiovascular disease.
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\1\ Heart Disease Facts; Centers for Disease Control and
Prevention. https://www.cdc.gov/heartdisease/facts.htm.
\2\ National Coalition for Heart and Stroke Research; American
Heart Association. http://www.heart.org/HEARTORG/Advocate/
IssuesandCampaigns/Research/National-Coalition-for-Heart-and-Stroke-
Research_UCM_428347_Article.jsp#.Wt4h-m4vypo.
\3\ Decline in Cardiovascular Mortality; National Library of
Medicine. https://www.ncbi.nlm.
nih.gov/pmc/articles/PMC5268076/.
\4\ HHS/NIH/NHLBI FY2017 Congressional Justification Report;
https://www.nhlbi.nih.gov/sites/default/files/media/docs/
Final%20NHLBI%202017%20CJ_R508_v1_0.pdf.
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Preventing and treating CVD applies to long-term COVID-19 patients.
Recent studies have shown that cardiovascular consequences of COVID-19
extend beyond initial infection, and many COVID-19 survivors experience
some type of heart damage, even if they did not have underlying heart
disease and were never hospitalized. Imaging tests taken months after
recovery from COVID-19 have shown lasting damage to the heart muscle in
people who experienced only mild symptoms, which may increase the risk
of heart failure or other heart complications in the future.\5\ As CVD
continues to be the country's leading cause of death while COVID-19
infections also present risks to cardiovascular health, we recommend
the NHLBI be funded at $3.965 billion to support research on COVID-19
by leveraging existing NIH-funded studies and infrastructure, and to
maintain current activities and investment toward new research and
emerging technologies related to heart disease.
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\5\ https://www.mayoclinic.org/diseases-conditions/coronavirus/in-
depth/coronavirus-long-term-effects/art-20490351.
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More than 11 million Americans have heart valve disease (HVD) which
involves damage to one or more of the heart's valves and leads to
disrupted blood flow by not opening or closing properly.\6\ HVD can
lead to major complications and some people with HVD do not always have
symptoms, even if their disease is severe. ACC recommends that the
NHLBI address gaps in understanding heart valve disease to better
recognize indicators of patients at higher risk of sudden cardiac
death. We propose report language to better understand and develop
guidelines for treatment of high-risk patients: The committee
recognizes that heart valve disease involves damage to one or more of
the heart's valves, and symptoms can be difficult to detect and lead to
major complications. The committee encourages the NHLBI to expand
research on valvular disease to better understand and develop
guidelines for treatment of high-risk patients by using precision
medicine and advanced technological imaging to generate data,
identifying and developing a cohort of individuals with valvular heart
disease and available data, and corroborating data generated through
clinical trials to develop a prediction model to identify patients at
high risk for sudden cardiac arrest or sudden cardiac death from
valvular disease.
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\6\ Heart Valve Disease Awareness Day; https://
www.valvediseaseday.org/the-issue/.
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The CDC plays a vital role in protecting public health through
healthy lifestyle promotion and educational activities designed to curb
non-infectious diseases such as obesity, diabetes, stroke, and heart
disease. The CDC Division for Heart Disease and Stroke Prevention
supports efforts to improve cardiovascular health by promoting healthy
lifestyles and behaviors, healthy environments, and access to early
detection and affordable treatment. The division engages with local and
state health departments, and a variety of other partners, to provide
funding and resources, conduct research, track risk factors, and
evaluate current programs and policies relating to heart disease. We
recommend that the CDC Division for Heart Disease and Stroke Prevention
be funded at $160 million to explore the intersections between COVID-19
and cardiovascular disease; build or enhance critical data
infrastructure; and expand current work in priority areas through new
partnerships, programs, and projects, all focused on eliminating
disparities in health outcomes.
Launched in 2012 and co-led by the CDC and the Centers for Medicare
and Medicaid Services, the Million Hearts program coordinates and
enhances CVD prevention activities with the objective of preventing 1
million heart attacks and strokes in 5 years. The initiative aims to
achieve this goal by encouraging the public to lead a healthy and
active lifestyle, as well as improving medication adherence for aspirin
and other medications to manage blood pressure, cholesterol, and
smoking cessation. New funding would frontload the success of Million
Hearts by facilitating extensive partner input into the design of the
next five-year phase; integration of insights gleaned from the
pandemic, including and especially the inequities further exposed by
COVID-19; and analysis of the individual, community, and healthcare
actions with the greatest impact on cardiovascular health for all. We
recommend that Million Hearts be funded at $10 million to enhance
efforts preventing heart attacks and strokes.
CDC's WISEWOMAN initiative provides more than 165,000 under-
insured, low-income women ages 40-64 with services to help reduce heart
disease and stroke risk factors. Heart disease ranks as the leading
cause of death for women. Only 1 in 5 \7\ women believes heart disease
is her greatest health threat, and 11 percent \8\ of women remain
uninsured. We recommend that $46.7 million be allocated for WISEWOMAN
to provide preventive health services, referrals to local health care
providers, lifestyle programs, and counseling in all 50 states.
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\7\ WISEWOMAN; Centers for Disease Control and Prevention. https://
www.cdc.gov/
wisewoman/.
\8\ Women's Health Insurance Coverage; The Henry J. Kaiser Family
Foundation. http://kff.org/womens-health-policy/fact-sheet/womens-
health-insurance-coverage-fact-sheet/.
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Congenital heart disease (CHD), a life-long consequence of a
structural abnormality of the heart present at birth, is the number one
birth defect in the U.S. While the diagnosis and treatment of CHD has
greatly improved over the years, most patients with complex heart
defects need special care throughout their lives, and only by expanding
research opportunities can we fully understand the effects of CHD
across the lifespan. As authorized by the Congenital Heart Futures
Reauthorization Act of 2017, we recommend that the CDC National Center
for Birth Defects and Developmental Disabilities be funded at $10
million for enhanced CHD surveillance and public health research.
Programs within CDC's Office on Smoking and Health (OSH) work to
prevent smoking among young adults and eliminate tobacco-related health
disparities in different population groups. From 2012-2018, the CDC
estimates that more than 16.4 million people who smoke have attempted
to quit and about 1 million have successfully quit because of the OSH
Tips from Former Smokers campaign.\9\ While these programs have proven
effective in tobacco cessation and prevention, more than 480,000 people
still die every year from causes attributable to smoking, and 33
percent of those deaths stem from heart disease\10\ We recommend that
OSH be funded at $310 million to continue leading the nation's efforts
in preventing chronic diseases caused by tobacco use.
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\9\ CDC Office on Smoking and Health; https://www.cdc.gov/
chronicdisease/pdf/aag/osh-H.pdf.
\10\ FDA Tobacco Products Public Health Information; https://
www.fda.gov/tobacco-products/public-health-education/health-
information.
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On behalf of our members who work to prevent and treat CVD, ACC
would like to thank members of Congress for supporting medical
innovation as we continue the fight against heart disease and
understand the cardiovascular consequences of COVID-19. Stable funding
for medical research and healthy lifestyle promotion will save lives
and health care costs in the long term by creating jobs and new
technologies, which will produce billions of dollars in Medicare and
Medicaid savings over the next decade. Please help us secure robust
funding for NIH and CDC funding to protect the health of future
generations.
[This statement was submitted by Dipti Itchhaporia, MD, FACC,
President,
American College of Cardiology.]
______
Prepared Statement of the American College of Obstetricians and
Gynecologists
The American College of Obstetricians and Gynecologists (ACOG),
representing more than 60,000 physicians and partners dedicated to
advancing women's health, is pleased to offer this statement to the
Senate Committee on Appropriations, Subcommittee on Labor, Health and
Human Services, Education, and Related Agencies. We thank Chairwoman
Murray, Ranking Member Blunt, and the entire Subcommittee for this
opportunity to provide comments on some of the most important programs
to support and advance women's health in FY22. ACOG commends Congress
for making great strides to support research and data collection that
advance the health of women and families. Looking ahead, we urge you to
appropriate:
--Centers for Disease Control & Prevention (CDC): At least $10
billion for the CDC, including $102.5 million for the Safe
Motherhood Initiative, including $30 million for maternal
mortality review committees and $30 million for perinatal
quality collaboratives; and $250 million for public health
surveillance;
--National Institutes of Health (NIH): $46.1 billion for the NIH,
including at least $1.7 billion for Eunice Kennedy Shriver
National Institute of Child Health and Human Development
(NICHD), and $50 million shared evenly between CDC and NIH, for
research into firearm morbidity and mortality prevention;
--Health Resources & Services Administration (HRSA): $750 million for
the Title V Maternal and Child Health Block Grant, including
$15 million for the Alliance for Innovation on Maternal Health
(AIM) within the Special Projects of Regional and National
Significance (SPRANS); $10 million to expand depression
screening and treatment for pregnant and postpartum women; and
$5 million to establish, identify, and distribute clinicians in
maternity care health professional target areas;
--Office of Population Affairs (OPA): $737 million for the Title X
Family Planning Program; and
--$500 million for the Agency for Healthcare Research and Quality
(AHRQ).
Safe Motherhood Initiative at CDC: The United States has the
highest rate of maternal mortality and severe morbidity of any
industrialized country. The Safe Motherhood Initiative at CDC works
with state health departments to collect information on pregnancy-
related deaths, supports maternal mortality review committees (MMRCs),
tracks preterm births, and improves maternal outcomes through perinatal
quality collaboratives. Important strides have been made as nearly
every state either currently has, is in the process of implementing, or
is making plans to develop a state MMRC. In addition, the CDC currently
supports 13 perinatal quality collaboratives (PQCs), often considered
the implementation arm of MMRCs. We must continue to build on this
progress and improve maternal health outcomes. ACOG requests that you
fund the Safe Motherhood Initiative at $102.5 million, including $30
million to help states expand or establish maternal mortality review
committees, and $30 million to support state-based perinatal quality
collaboratives in every state.
Women's Health Research at NIH: Women represent half of the US
population. As such, conditions and diseases that are specific to
women's health, or those that present differently in women than men,
must be a priority for federally funded research. Women's health
research is a central part of the research mission and portfolio of
NICHD, and the Institute has achieved great success in advancing
research on women's health throughout the life cycle; maternal, child,
and family health; fetal development; reproductive biology; population
health; and medical rehabilitation. With sufficient resources, NICHD
can build upon existing initiatives to produce new insights and
solutions to benefit women and families. ACOG supports an appropriation
of $46.1 billion for the NIH in FY22, including at least $1.7 billion
for NICHD.
Maternal Therapeutics at NIH: In the United States each year, more
than 4 million women give birth and more than 3 million breastfeed.
However, little is known about the effects of most drugs on the woman
and her child. In 2015 as part of the 21st Century Cures Act (Sec. 2041
of P.L. 114-255), Congress created the Task Force on Research Specific
to Pregnant Women and Lactating Women (PRGLAC) to advise the Secretary
of HHS on gaps in knowledge and research on safe and effective
therapies for pregnant and breastfeeding women. In August 2020, PRGLAC
produced an implementation plan for each of the 15 recommendations made
in 2018 to facilitate the inclusion of this population in clinical
research. ACOG supports the implementation of these recommendations
under the oversight of NICHD, working with other relevant NIH
Institutes, the CDC, and the Food and Drug Administration, and urges
Congress to express its continued support.
Title X Family Planning Program at OPA: Title X is the only federal
program dedicated to providing family planning services for people with
low incomes. For many individuals, particularly those who are low-
income, uninsured, or adolescents, Title X is essential to their
ability to affordably and confidentially obtain birth control, cancer
screenings, STI tests and other basic care. Title X has been cut or
flat-funded every year for the past decade. A significant investment is
needed to support robust restoration of the program and ensure demand
for services is met. ACOG requests $737 million for Title X in FY22 to
ensure individuals in need have access to evidence-based care. ACOG is
pleased that the Biden administration has proposed to eliminate the
2019 Title X regulations that decreased access to health care services
and disproportionately imposed barriers to care for Black, Latinx, and
Indigenous communities. ACOG urges Congress to show its strong support
for transparent, respectful, evidence-based, and comprehensive
reproductive health care by funding this critical program.
Title V Maternal and Child Health Block Grant at HRSA: The Title V
Maternal and Child Health (MCH) Block Grant at HRSA is the only federal
program that exclusively focuses on improving the health of mothers and
children. The Block Grant is a cost-effective, accountable, and
flexible funding source used to address critical, pressing, and unique
needs of maternal and child health populations in each state, territory
and jurisdiction. Notably, through the SPRANS discretionary grant, the
Block Grant supports the Alliance for Innovation on Maternal Health
(AIM) program--a program that works with states and hospital systems to
implement evidence-based best practices to improve maternal health
outcomes and reduce rates of maternal mortality and severe maternal
morbidity. For FY22, ACOG requests at least $750 million to respond to
the increased demands placed on the Block Grant, including $15 million
within SPRANS to support continued implementation of AIM.
Investing in Data and Quality at AHRQ: AHRQ is the federal agency
with the sole purpose of improving health care quality. AHRQ produces
data with the mission of making health care safer, higher quality, more
accessible, equitable, and affordable. AHRQ works with HHS and other
partners to ensure that the evidence improves patient safety. ACOG
supports $500 million for AHRQ in FY22, which reflects the FY10 funding
level for the agency adjusted for inflation and additional funding to
respond to the pandemic.
Public Health Surveillance at CDC: Uniform, accurate, and
comprehensive data is essential for addressing the rising rates of
maternal mortality and severe maternal morbidity in the US.
Unfortunately, the nation's public health data systems are antiquated,
lack interoperability and data and reporting standards, and are in dire
need of security updates. ACOG urges Congress to include a robust
investment in public health surveillance, and requests funding to be
used to modernize these systems to improve health. ACOG requests $250
million in FY22 for public health surveillance at CDC to implement
advanced technologies and train the next generation of data scientists.
Firearm Morbidity and Mortality Prevention (CDC and NIH): In 2017,
there were more than 39,000 U.S. firearm-related fatalities. Federally
funded public health research has a proven track record of reducing
public health-related deaths, whether from motor vehicle crashes,
smoking, or Sudden Infant Death Syndrome. This same approach should be
applied to increasing gun safety and reducing firearm-related injuries
and deaths, and CDC research will be as critical to that effort as it
was to these previous public health achievements. The foundation of a
public health approach is rigorous research that can accurately
quantify and describe the facets of an issue and identify opportunities
for reducing its related morbidity and mortality. For FY22, ACOG
requests $50 million, shared evenly between CDC and NIH, to conduct
public health research into firearm morbidity and mortality prevention.
Diagnosing and Treating Maternal Depression (HRSA): About 1 in 5
women experience maternal depression, and ACOG recommends that all
women be screened, yet barriers to accessing treatment remain. ACOG
commends Congress for funding Sec. 10005 of P.L. 114-255 to support the
establishment of a program at HRSA to expand depression screening and
treatment for pregnant and postpartum individuals. ACOG urges you to
fund the program at $10 million for FY22, a $5 million increase over
FY21, and increase support for the maternal mental health hotline to $5
million.
Maternity Care Target Areas (HRSA): Major pockets of the U.S. do
not have adequate access to needed maternity care, due to both a
workforce shortage and maldistribution of clinicians. This
disproportionately impacts access to obstetric care in rural
communities. Maternity care shortages threaten the ability of pregnant
individuals to receive timely prenatal and labor/delivery services.
According to the latest available data, more than half of pregnant
people living in rural areas reside more than 30-minutes by car from
the nearest hospital offering perinatal services. Further, a 2019 study
that analyzed severe maternal morbidity and mortality during childbirth
hospitalizations among rural and urban residents found that when
controlling for sociodemographic factors and clinical conditions, rural
residents had a 9 percent greater probability of severe maternal
morbidity and mortality, compared with urban residents.
The Improving Access to Maternity Care Act of 2018 (P.L. 115-320)
requires HRSA to identify maternity care health professional target
areas that are suffering from a shortage of maternity care clinicians,
including obstetrician-gynecologists and certified nurse-midwives, so
that those participating in the National Health Service Corps can be
placed in the communities most in need of their services. ACOG urges
you to fulfill the President's request for $5 million in FY22 to
implement the Improving Access to Maternity Care Act. Funding would be
used to establish criteria for and identify maternity care health
professional target areas, distribute maternity care health
professionals to those areas, and collect and publish data on the
availability and need for maternity care services within primary care
health professional shortage areas.
Thank you again for the opportunity to submit our recommendations
to the
subcommittee, and for your commitment to improving women's health.
______
Prepared Statement of the American College of Physicians
The American College of Physicians (ACP) is pleased to submit the
following statement for the record on its priorities, as funded under
the U.S. Department of Health & Human Services, for Fiscal Year (FY)
2022. ACP is the largest medical specialty organization and the second-
largest physician group in the United States. ACP members include
163,000 internal medicine physicians (internists), related
subspecialists, and medical students. Internal medicine physicians are
specialists who apply scientific knowledge and clinical expertise to
the diagnosis, treatment, and compassionate care of adults across the
spectrum from health to complex illness. As the Subcommittee begins
deliberations on appropriations for FY2022, ACP is urging funding for
the following proven programs to receive appropriations from the
Subcommittee:
--Health Resources Services Administration (HRSA), $9.2 billion;
--Title VII, Section 747, Primary Care Training and Enhancement
(PCTE), Health Resources and Services Administration (HRSA),
$71 million;
--National Health Service Corps (NHSC), $860 million in total program
funding;
--Agency for Healthcare Research and Quality (AHRQ), $500 million;
--Centers for Medicare and Medicaid Services (CMS), Program
Operations for Federal Exchanges, $296.5 million;
--Centers for Disease Control and Prevention (CDC), $10 billion,
Injury Prevention and Control, Firearm Injury and Mortality
Prevention Research, $50 million; National Center for Chronic
Disease Prevention and Health Promotion (NCCDPHP), Social
Determinants of Health program, $153 million;
--National Institutes of Health (NIH), $46.1 billion.
The United States is facing a shortage of physicians in key
specialties, notably in general internal medicine and family medicine-
the specialties that provide primary care to most adult and adolescent
patients. Current projections indicate there will be a shortage of
21,400 to 55,200 primary care physicians by 2033. Without critical
funding for vital workforce programs, this physician shortage will only
grow worse. HRSA is responsible for improving access to health-care
services for people who are uninsured, isolated or medically
vulnerable. Without critical funding for vital workforce programs, this
physician shortage will only grow worse. A strong primary care
infrastructure is an essential part of any high-functioning healthcare
system. A recent report by the National Academy of Sciences, calls on
policymakers to increase our investment in primary care as evidence
shows that it is critical for achieving health care's quadruple aim
(enhancing patient experience, improving population, reducing costs,
and improving the health care team experience. Therefore, we urge the
Subcommittee to provide $9.2 billion for HRSA programs for FY2022 to
improve the care of medically underserved Americans by strengthening
the health workforce.
The health professions' education programs, authorized under Title
VII of the Public Health Service Act and administered through HRSA,
support the training and education of health care providers to enhance
the supply, diversity, and distribution of the health care workforce.
Within the Title VII program, we urge the Subcommittee to fund the
Section 747 PCTE program at $71 million, in order to maintain and
expand the pipeline for individuals training in primary care. While the
College appreciates the $10 million increase to the program in FY2018,
ACP urges more funding because the Section 747 PCTE program is the only
source of federal training dollars available for general internal
medicine, general pediatrics, and family medicine. For example, general
internists, who have long been at the frontline of patient care, have
benefitted from PCTE grants for primary care training in rural and
underserved areas that have helped prepare physicians for a career in
primary care.
The College urges at least $860 million in total program funding
for the NHSC in FY2022. In FY2021, the NHSC received $120 million in
discretionary funding to expand and improve access to quality opioid
and substance use disorder treatment in underserved areas, in addition
to $310 million in mandatory funds which have been extended through
FY2023. The NHSC awards scholarships and loan repayment to health care
professionals to help expand the country's primary care workforce and
meet the health care needs of underserved communities across the
country. In FY2020, with a projected field strength of over 14,000
primary care clinicians, NHSC members are providing culturally
competent care to a target of almost 15 million patients at a targeted
18,000 NHSC-approved health care sites in urban, rural, and frontier
areas. These funds would help maintain NHSC's field strength helping to
address the health professionals' workforce shortage and growing
maldistribution. There is overwhelming interest and demand for NHSC
programs, and with more funding, the NHSC could fill more primary care
clinician needs. In FY2016, there were 2,275 applications for the
scholarship program, yet only 205 new awards were made. There were only
150 scholarship awards in FY2020. There were 7,203 applications for
loan repayment and only 3,079 new awards in FY2016. Accordingly, ACP
urges the subcommittee to double the NHSC's overall program funding to
$860 million to meet this need and to sustain the American Rescue Plan
Act's $800 million for the NHSC for when the pandemic subsides.
AHRQ is the leading public health service agency focused on health
care quality. AHRQ's research provides the evidence-based information
needed by consumers, clinicians, health plans, purchasers, and
policymakers to make informed health care decisions. The College is
dedicated to ensuring AHRQ's vital role in improving the quality of our
nation's health and recommends a budget of $500 million, restoring the
agency to its FY2010 enacted level adjusted for inflation. This amount
will allow AHRQ to help providers help patients by making evidence-
informed decisions, to fund research that serves as the evidence engine
for much of the private sector's work to keep patients safe, and to
make the healthcare more efficient by providing quality measures to
health professionals.
ACP supports at least $296.5 million in discretionary funding for
federal exchanges within CMS' Program Operations, which has been funded
at $2.8 billion in FY2020. This funding would allow the federal
government to continue administering the insurance marketplaces, as
authorized by the Affordable Care Act, if a state has declined to
establish an exchange that meets federal requirements. CMS now manages
and operates some or all marketplace activities in over 30 states.
Without these funds it will be much more difficult for the federal
government to operate and manage a federally-facilitated exchange in
those states, raising questions about where and how their residents
would obtain and maintain coverage, especially with increased need for
health coverage due to the COVID-19 pandemic.
The Center for Disease Control and Prevention's mission is to
collaborate to create the expertise, information, and tools needed to
protect their health-through health promotion, prevention of disease,
injury, and disability, and preparedness for new health threats. ACP
supports $10 billion overall for this mission, especially in light of
the ongoing COVID-19 public health emergency (PHE). The College also
supports $50 million for the CDC's Injury and Prevention Control to
fund research on firearm Injury and mortality prevention research and
support 10 to 20 multi-year studies to continue to continue to rebuild
lost research capacity in this area. ACP greatly appreciates funding
for this research in FY2020 and FY2021 after many years of no federal
resources for researching the prevention of firearms-related injuries
and deaths. The College also supports the administration's budget
request of $153 million for the NCCDPHP to fund its Social Determinants
of Health program. The PHE caused by the COVID-19 has highlighted the
urgent need to collect racial, ethnic, and language preference
demographic data on testing, infection, hospitalization, and mortality
during a pandemic. These data should be shared with local, state,
territorial, and tribal governments. Frequent, granular, and high-
quality disaggregated demographic data are needed to fully understand
the impact on racial and ethnic minority communities and better offer
targeted care not only for COVID-19, but for health care overall.
Lastly, the College strongly supports $46.1 billion for NIH in
FY2022 so the nation's medical research agency continues making
important discoveries that treat and cure disease to improve health and
save lives and that maintain the United States' standing as the world
leader in medical and biomedical research.
The College greatly appreciates the support of the Subcommittee on
these issues and looks forward to working with Congress on the FY2022
appropriations process.
[This statement was submitted by Jared Frost, Senior Associate,
Legislative
Affairs, American College of Physicians.]
______
Prepared Statement of the American College of Surgeons
Chairwoman Murray, Ranking Member Blunt, and Members of the
Subcommittee, on behalf of the more than 82,000 members of the American
College of Surgeons (ACS), thank you for the opportunity to submit
written testimony addressing fiscal year (FY) 2022 appropriations. The
ACS is a scientific and educational organization of surgeons that was
founded in 1913 to raise the standards of surgical practice and improve
the quality of care for all surgical patients. ACS is dedicated to the
ethical and competent practice of surgery. Its achievements have
significantly influenced the course of scientific surgery in America
and have established it as an important advocate for all surgical
patients.
The ACS respectfully requests your consideration of the following
priorities as the Subcommittee works through the annual appropriations
process for FY 2022:
Military and Civilian Partnership for the Trauma Readiness Grant
Program (MISSION ZERO)
In 2016, the National Academies of Science, Engineering, and
Medicine (NASEM) released a report titled, ``A National Trauma Care
System: Integrating Military and Civilian Trauma Systems to Achieve
Zero Preventable Deaths After Injury.'' This report suggests that one
in four military trauma deaths and one in five civilian trauma deaths
could be prevented if advances in trauma care reach all injured
patients. The report concludes that military and civilian integration
is critical to saving lives both on the battlefield and at home,
maintaining the nation's readiness and homeland security.
The MISSION ZERO Act was signed into law on June 24th, 2019 as part
of S. 1279, the Pandemic and All Hazards Preparedness and Advancing
Innovation (PAHPAI) Act (Public Law No:116-22). MISSION ZERO takes the
recommendations of the NASEM report to create a grant program, within
the U.S. Department of Health and Human Services (HHS), to cover the
administrative costs of embedding military trauma professionals in
civilian trauma centers. These military-civilian trauma care
partnerships will allow military trauma care teams and providers to
gain exposure to treating critically injured patients and increase
readiness for when these units are deployed, further advancing trauma
care and providing greater patient access.
By facilitating the implementation of military-civilian trauma
partnerships, this program will preserve lessons learned from the
battlefield, translate those lessons to civilian care, and ensure that
service members maintain their readiness to deploy in the future. The
ACS strongly supports the funding of MISSION ZERO at the authorized
amount of $11.5 million for FY 2022.
Funding for Cancer Research and Prevention
The ACS Cancer Programs, including the Commission on Cancer (CoC),
is dedicated to improving survival and quality of life for cancer
patients through advocacy on issues pertaining to prevention and
research. To continue the progress that has led to medical
breakthroughs for treatment therapies for millions of cancer patients,
the ACS supports the following funding increases for FY 2022.
To ensure a robust, long-term commitment to cancer research and
prevention, Congress should increase the overall budget of the National
Institutes of Health (NIH) to at least $46.111 billion including $7.609
billion for the National Cancer Institute (NCI). The ACS also urges the
inclusion of $559 million for cancer programs at the Centers for
Disease Control and Prevention (CDC), including $50 million for the
National Comprehensive Cancer Control Program, and $70 million for the
National Program of Cancer Registries (NPCR).
Firearm Morbidity and Mortality Prevention Research
According to the Centers for Disease Control and Prevention (CDC),
there were more than 39,000 firearm-related fatalities in 2019, a
measured increase over previous years. ACS believes this number can be
reduced through federally funded firearms research. As with other
injury prevention related efforts, public health research can play a
role in reducing the number of firearm-related injuries and deaths.
Federally funded research from the perspective of public health has
contributed to reductions in motor vehicle crashes, smoking, and Sudden
Infant Death Syndrome (SIDS). ACS believes that a similar approach can
provide necessary data to inform efforts to reduce firearm-related
injuries and deaths. The ACS supports $50 million specifically for
public health research into firearm morbidity and mortality prevention
through the CDC for FY 2022.
Removal of Language in Section 510
Serious patient safety concerns arise if a patient's health record
is mismatched or includes inaccurate or incomplete information,
potentially resulting in missed allergies, medication interactions, or
duplicate tests ordered. Unfortunately, there is no accurate or
consistent way for surgeons to link patients to their health
information across the continuum of care, due to long-standing federal
statutory language. The language, located in Section 510 of the LHHS
Appropriations bill, has prohibited HHS from spending any federal
dollars to promulgate or adopt a Unique Patient Identifier, thereby
hampering public-private sector collaborative efforts to advance a
nationwide patient identification strategy that is cost-effective,
scalable, secure, and prioritizes patient privacy.
Removing the language in Section 510 will provide HHS with the
ability to evaluate a range of patient identification solutions and
enable the agency to work with the private sector to explore potential
challenges. ACS supports removal of Section 510 from the Labor-HHS
appropriations bill that prohibits HHS from spending any federal
dollars to promulgate or adopt patient identification strategies.
Thank you for your consideration of our requests. Please contact
Amelia Suermann, ACS Congressional Lobbyist, at [email protected] if
you have any questions or would like additional information.
______
Prepared Statement of the American Educational Research Association
Chair Murray, Ranking Member Blunt, and Members of the
Subcommittee, thank you for the opportunity to submit written testimony
on behalf of the American Educational Research Association (AERA). AERA
recommends that the Institute of Education Sciences (IES) within the
Department of Education receive $737.47 million for FY 2022, aligned
with the top line included in the president's budget request. This
recommendation is also consistent with the request from the Friends of
IES coalition, for which we are a leading member. In addition, AERA
recommends the base funding level of $46.1 billion for the National
Institutes of Health (NIH) in fiscal year 2022, in support of important
research in the Eunice Kennedy Shriver National Institute of Child
Health and Human Development (NICHD) and the Office of Behavioral and
Social Science Research (OBSSR).
AERA is the major national scientific association of 25,000
faculty, researchers, graduate students, and other distinguished
professionals dedicated to advancing knowledge about education,
encouraging scholarly inquiry related to education, and promoting the
use of research to improve education and serve the public good. Our
members, as well as state and federal policymakers and practitioners,
rely on IES to provide and support reliable education statistics, data,
research, and evaluations.
IES is the independent and nonpartisan statistics, research, and
evaluation arm of the U.S. Department of Education charged with
supporting and disseminating rigorous scientific evidence on which to
ground education policy and practice. Located within the Department of
Education to provide essential education data, statistics, and science
to the Department, the federal government, and the nation, the mission
of IES is analogous to other prominent federal research agencies such
as the National Science Foundation and the National Institutes of
Health.
We appreciate the increase to IES appropriations over the past few
fiscal years and the funding provided in the American Rescue Plan Act,
the latter of which will go toward needed resources in data and special
education research to understand how schools will work to address
learning gaps due to lost instructional time. Throughout the pandemic,
IES has served as an important resource in providing information about
distance learning; pursuing interventions to address socioemotional
needs; and collecting salient data on schools offering remote, hybrid,
and in-person learning. The increased demand for evidence-based
programs since the onset of COVID-19 and the need to address potential
learning recovery only further speaks to the priority importance of
support for education research and statistics at IES to inform policy
and practice.
We see numerous examples of bipartisan support for scientific
research and evidence-based decision making. The Department of
Education is implementing the provisions of the bipartisan Foundations
of Evidence-Based Policymaking Act, which directs federal agencies to
leverage data and evaluations to inform policy decisions. A bipartisan
bill that has been introduced to inform the forthcoming reauthorization
of the Workforce Investment and Opportunity Act (WIOA) would call for
investment in research in adult education. The data and research
infrastructure to build evidence for improving educational outcomes
require additional funding necessitating action by your committee.
Since IES was created in 2002, it has made visible scientifically-
based contributions to the progress of education that are used in
classrooms across the country. For example, IES has funded research on
multi-tiered systems of support, including positive behavior
interventions and supports, that have been highlighted in the
Department of Education's COVID-19 handbook to guide school reopening.
Several webinars and resources produced by the Regional Educational
Laboratories highlighting evidence-based practices for educators,
school support staff, and school leaders are incorporated in the Safer
Schools and Campuses Best Practices Clearinghouse. As the nation
continues to emerge from the pandemic, this is a critical time to
invest in education research to produce essential knowledge about
teaching and learning across all levels of education as well as to
identify lessons learned that can foster educational innovations.
States are increasingly seeking ways to determine the long-term
impact of state policies, including in education, and they turn to
information in their Statewide Longitudinal Data Systems (SLDS).
Initially developed to help states measure accountability, data has
transformed from a hammer to a flashlight, increasing understanding
about student performance and teacher effectiveness. To date, IES has
been unable to meet the state demand for SLDS grants. For the FY 2019
competition, 28 of 44 states that submitted applications received
grants, although the average amount of grants was reduced by half
compared with those awarded in FY 2015. Growing interest in using data
from these systems, including an IES research competition encouraging
the research use of these data for examining longitudinal impacts of
state policies, show the importance of continuing investment in these
data systems.
AERA also is concerned with the reduced staff capacity at IES, and
I would like to draw particular attention to the decades-long staff
attrition at the National Center for Education Statistics (NCES). As
the second-oldest principal federal statistical agency in the United
States, NCES provides objective, nonbiased data on a wide range of
education indicators, including information on teacher salaries, the
amount of loans taken out by undergraduate students, and the
participation of students in English language learner programs. NCES
staff are also responsible for the development and administration of
the National Assessment of Educational Progress, detailing longitudinal
trends in student achievement. In recognizing the need for NCES to
produce accurate, reliable, and trustworthy data, we encourage the
subcommittee to ensure that NCES and IES have the appropriate level of
staff in order to effectively carry out their missions in the Program
Management line.
In addition to IES, AERA recommends $46.1 billion for the National
Institutes of Health (NIH) in fiscal year 2022 with proportional
increases for the Eunice Kennedy Shriver National Institute of Child
Health and Human Development (NICHD) and the Office of Behavioral and
Social Science Research (OBSSR). NICHD supports research at the
intersection of health and education, including ways to foster health
literacy, potential influencers of family environments on child well-
being and cognitive development, and interventions for students with
learning disabilities who struggle with reading. Investment in NICHD
will allow the institute to continue research to both increase
understanding how best to support executive functioning, and to bolster
the professional development of early career researchers. OBSSR plays
an important role in coordinating and co-funding behavioral and social
science research across NIH that contribute to the understanding of
influences on health and interventions to improve health outcomes.
OBSSR has long recognized the interdependence of education and health
and in terms of prevention, intervention, and the health-risk
consequences of a lack of or limited educational exposure.
Thank you for the opportunity to submit written testimony in
support of $737 million for IES and $46.1 billion in base level funding
for NIH in fiscal year 2022. AERA welcomes working with you and your
subcommittee on strengthening investments in essential research, data,
and statistics related to education and learning.
[This statement was submitted by Felice J. Levine, PhD, Executive
Director, American Educational Research Association.]
______
Prepared Statement of the American Foundation for Suicide Prevention
The American Foundation for Suicide Prevention (AFSP), the nation's
largest non-profit dedicated to saving lives and bringing hope to those
effected by suicide is submitting testimony on behalf of our over 30
thousand volunteer Field Advocates nationwide. AFSP has Chapters in all
50 states and sponsors a variety of community-based programming across
the country each year.
The following testimony outlines suicide in the United States and
AFSP's recommendations to the Subcommittee for Fiscal Year 2022.
suicide: a national public health crisis
Suicide is the second leading cause of death for ages 10-34 in the
United States and in 2019 was the 10th leading cause of death.\1\
Provisional 2020 suicide death data from the CDC show that deaths by
suicide in the U.S. declined from 47,511 to 44,834 (5.6%) between 2019
and 2020.\2\ Suicide reportedly moved from the tenth to the eleventh
leading cause of death as COVID-19 became the third leading cause of
death in 2020.\3\ While the decreases in suicide deaths are promising
and the curve may be beginning to shift downward, efforts must continue
to be expanded and built upon to ensure there are mental health
resources as the pandemic continues to shift and impact different
populations disproportionately. Historically, suicide rates have
initially gone down during some periods of wartime and other disasters
and have shown mixed results during or after previous epidemics.
Provisional 2020 data appear consistent with this trend. It is
possible, though not pre-determined, that we could experience an
increase in suicide risk as the immediate COVID-19 threat lessens and
in the aftermath period if community cohesion diminishes and if less
attention is paid to intentional social connections, proactive
resilience and mental health self-care, and the importance at key times
of engaging in mental health treatment and crisis care. Helping those
who are struggling with basic needs can also mitigate suicide risk.
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\1\ https://www.cdc.gov/injury/wisqars/index.html.
\2\ https://jamanetwork.com/journals/jama/fullarticle/
2778234?utm_source=newsletter&utm_
medium=email&utm_campaign=newsletter_axiosvitals&stream=top.
\3\ Ibid.
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While provisional 2020 mortality data show a declining rate of
suicide for the overall U.S. population, we do not yet have the full
picture as to how this translates to geographic areas within states or
specific populations. The pandemic has had a disproportionate impact on
certain populations; there are concerning signals of increasing suicide
rates in some non-White populations during the pandemic, e.g., in
Maryland and Connecticut.\4\ It may be a year or longer until data and
research are available to understand the entire impact of COVID-19 on
suicide.
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\4\ https://jamanetwork.com/journals/jamapsychiatry/fullarticle/
2774107.
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Furthermore, during the COVID-19 pandemic, data show 50-70% of the
population report elevations in experiences of depression, anxiety,
loneliness, trauma, loss, grief and increased substance use.\5\
Numerous studies have kept abreast of the nation's mental health
experiences and suffering during the pandemic through various
mechanisms such as the CDC Household Pulse Survey during COVID which
has been surveying 60-90,000 Americans adults every 3-5 weeks during
the pandemic. The portion of the American public experiencing anxiety,
isolation, symptoms of depression, insomnia and increased substance use
has been rising.
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\5\ https://www.cdc.gov/nchs/covid19/pulse/mental-health-care.htm.
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As the pandemic progressed during 2020, the proportion of
respondents who reported detrimental effects on their mental health
continued to rise--39% in May 2020 and 53% in July 2020. It was only
until just recently, in March 2021, that we are seeing the first
decreases in distress--8-10 percentage points--for depression and
anxiety across age and demographic groups.\6\ However, the CDC reported
on June 18, 2021 there was a 51 percent rise in suspected suicide
attempts among girls ages 12-17 from February 2021 to March 2021
compared to the same time period in 2019, prior to the pandemic.\7\
While this does not mean that there was necessarily an uptick in
suicide deaths, the statistic is certainly alarming, and we do not yet
have race and ethnicity data for when this study was conducted.
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\6\ https://www.cdc.gov/mmwr/volumes/69/wr/mm6932a1.htm.
\7\ https://www.cdc.gov/mmwr/volumes/70/wr/
mm7024e1.htm?s_cid=mm7024e1_w.
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recommendations
As instances of suicidal ideation and attempts increase, funding
and resources must meet the needs of those most at risk. Therefore,
AFSP is advocating for Fiscal Year 2022 funding increases to ensure
that communities are adequately prepared to respond to crisis,
implement community-based programming for those most at risk, collect
data to improve prevention, and to invest in research to meet patients
where they are, in healthcare settings. We thank Chairwoman Murray and
Ranking Member Blunt for the opportunity to share our below priorities.
Substance Abuse and Mental Health Services Administration (SAMHSA)
The National Suicide Prevention Lifeline coordinates a network of
over 180 crisis centers across the United States by providing 24/7 free
and confidential suicide prevention and crisis intervention services
for people in distress, their loved ones, and best practices for
professionals. The Lifeline routes calls from anywhere in the country
to a network of certified local crisis centers that can then link
callers to local emergency, mental health, and social services
resources. Last year, over 2.5 million calls were made to the Lifeline,
resulting in longer wait times and a strain on local crisis centers.
Additional funding is needed to ensure that the Lifeline is adequately
equipped to handle increasing call and outreach volume.
We request at least $102 million for the National Suicide
Prevention Lifeline, as included in the President's Fiscal Year 2022
Budget Request. Following passage of the National Suicide Hotline
Designation Act in September 2020, the easily accessible 9-8-8 dialing
code was designated to replace the Lifeline's current 1-800 number. 9-
8-8 will be the new easy to remember and universal phone number for
suicide prevention and mental health crisis by July 2022. This presents
an urgent need to ensure that local crisis call centers and the
national infrastructure for the Lifeline are prepared for the
anticipated increase in calls and strain on an already overburdened
system. Additional funding to the Lifeline would facilitate the
development of a unified call center platform and data analytics,
telecom costs for each contact and routing to local crisis centers,
provision of specialized services at national back up centers for
calls, chat, and text, targeted funding for call centers and national
backup centers, multi-lingual assistance, quality assurance and
training standards, and supporting partnership outreach. Based on an
initial analysis from Vibrant Emotional Health, the current
administrator of the Lifeline, year one implementation estimates for
988 could grow to as much as $240 million. It is expected that SAMHSA
and the Department of Veterans Affairs (VA) will jointly release a
final cost estimate report to Congress regarding Lifeline funding needs
later in the summer of 2021 which will help better inform the critical
resource needs that are urgently needed. We hope the Appropriations
Committee will work with us to adequately address this critical
resource, in Fiscal Year 2022 and beyond.
The Centers for Disease Control (CDC)
As the nation's leading health protection agency, it is a natural
fit that the CDC expand their suicide prevention efforts. Through
investing further in the CDC's new suicide prevention line, there is a
more holistic approach to suicide prevention programming beyond the
work that SAMHSA and the National Institutes of Health (NIH) are
implementing, evaluating, and researching. There is a need to make
strategic investments that will help save lives and reduce the suicide
rate. Therefore, AFSP advocates for $36 million for Suicide Prevention
initiatives at CDC's Center for Injury Prevention and Control. Created
in Fiscal Year 2020, the Congress has generously provided $22 million
for the program over the last two fiscal years. Enhanced funding in
Fiscal Year 2022 will help expand these community-based grants into
approximately 25 states. The grants are used to implement and evaluate
a comprehensive public health approach to suicide prevention, with
attention to vulnerable populations, such as Veterans, tribal and rural
communities, LGBTQ, or homeless citizens. These groups account for a
significant proportion of the suicide burden and have suicide rates
greater than the general population. A key outcome of this funding is a
10% reduction in suicide and suicide attempts among vulnerable
populations. Through these cooperative agreements, CDC aims to build a
national program that will help reverse increasing suicide trends
across our nation and contribute to the national goal of reducing
suicide by 20% by 2025.
Data collection as it relates to suicide deaths is an important
piece of preventing future deaths and implementing prevention
strategies within our communities. AFSP advocates for a $10 million
increase for the National Violent Death Reporting System (NVDRS) as
included in the President's Fiscal Year 2022 Budget Request. NVDRS is
the most comprehensive database on circumstances surrounding violent
deaths in the U.S., including suicide. Since the program's inception in
2002, NVDRS has grown to a nationwide program with funding to support
implementation in all 50 states and select territories. Yet, the
current funding is not sufficient for long-term program success. States
are clamoring for additional resources to address various
implementation challenges and support investments in program
infrastructure, as well as program growth and innovation. NVDRS
stakeholder organizations support a funding level of $50 million by FY
2027 to strengthen the program.
National Institute of Mental Health
As the largest private funder of suicide prevention research in the
US, AFSP continues to advocate for increased federal funding and
prioritization of suicide prevention research. The National Institutes
for Health and more specifically the National Institute of Mental
Health (NIMH) play a key role in advancing the Nation's suicide
prevention research priorities. AFSP encourages the continued
implementation of the Prioritized Research Agenda for Suicide
Prevention released by the National Action Alliance for Suicide
Prevention, that is meant to advance the National Strategy for Suicide
Prevention. To note, more recently, in January 2021, there was a
Surgeon Generals Call to Action to Implement the National Strategy for
Suicide Prevention, which further outlines the six actions and
associated strategies that will move the U.S. further towards
implementation of the National Strategy. Overall imparting the need for
increased federal investment in suicide prevention research and
programmatic needs.
As the COVID-19 pandemic shifts, there is a need to ensure that
when individuals are visiting the Emergency Department or their primary
care physician that screening tools and resources meet them, so if they
are in need of mental health and crisis services, they are able to
receive comprehensive care. This is an especially prominent area for
necessary research as, up to 45 percent of people who die by suicide
visit their primary care physician in the month prior to their
death.\8\ AFSP recommends the following report language for Fiscal Year
2022, to place a special emphasis on the primary care setting, given
the great number of Americans seeking mental health care from their
primary care physician.
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\8\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146379/
#: :text=A%20review%20of%20
studies%20analyzing,the%20month%20before%20their%20death.&text=Only%2020
%25%20 saw%20a%20mental,10%20in%20the%20preceding%20month.
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proposed fiscal year 2022 report language: suicide prevention
The Committee is encouraged that 2019 was the first year in two
decades in which the suicide rate decreased. But death by suicide
remains the tenth leading cause of death in the United States, and the
Committee remains committed to providing the resources necessary to
address this alarming crisis. The Committee commends NIMH for
consistently expanding resources for suicide screening and prevention
research over the last four fiscal years and strongly encourages the
Institute to provide additional increases for this purpose in fiscal
year 2022, with special emphasis on producing models that are
interpretable, scalable, and practical for clinical implementation,
including utilization of healthcare, education and criminal justice
systems that serve populations at risk. In addition, the Committee
encourages NIMH to prioritize research efforts related to primary care
settings to evaluate suicide prevention interventions, strategies, and
programs, including assessments of the effects of the COVID-19
epidemic. The Committee requests that NIMH provide an update on these
efforts in the fiscal year 2023 Congressional Justification.
The American Foundation for Suicide Prevention is grateful for the
Subcommittee's continued support of suicide prevention efforts and
looks forward to additional conversations about the vital resources
needed to help save lives and prevent suicide. Please do not hesitate
to contact Natalie Tietjen, Manager of Federal Policy
([email protected]) on my staff with additional questions or
clarifications.
[This statement was submitted by Laurel Stine, JD, MA, Senior Vice
President, Public Policy, American Foundation for Suicide Prevention.]
______
Prepared Statement of the American Gastroenterological Association
national cancer institute
Chairwoman Murray, Ranking Member Blunt, and members of the
Subcommittee, I would like to start by thanking you for the opportunity
to submit testimony on the U.S. Department of Health and Human Services
(HHS) fiscal year (FY) 2022 appropriations bill. I am Dr. Fola May, and
I am an associate professor of medicine at the University of
California, Los Angeles, and researcher at the UCLA Center for Cancer
Prevention Control Research (CPCR) and UCLA Kaiser Permanente Center
for Health Equity. I am submitting testimony on behalf of the American
Gastroenterological Association (AGA). The AGA was founded in 1897, and
today, it has expanded its membership to include more than 16,000
professionals who are dedicated to the advancement of science,
practice, and research in the field of gastroenterology. We want to
first thank you for your ongoing bipartisan investment in the National
Institutes of Health (NIH). We respectfully request the subcommittee to
support our FY 2022 NIH funding recommendation of at least $46.111
billion, a $3.177 billion increase over the comparable FY 2021 funding
level for the NIH, which would allow for the NIH's base budget to keep
pace with the biomedical research and development price index of 2.3 %
and allow meaningful growth of 5%. Additionally, we request report
language to support research to better understand the impact of COVID-
19 on colorectal cancer disparities.
Colorectal Cancer Incidence
Colorectal cancer (CRC) remains the second leading cause of cancer
deaths in the United States. The American Cancer Society (ACS) \1\
estimates 149,500 new cases of CRC and 52,980 CRC-related deaths in the
U.S. in 2021. The ACS 2021 cancer report also shows an emerging trend
of CRC in a younger demographic; The data shows a 2% increase in CRC in
individuals under 50 years.
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\1\ American Cancer Society. Cancer Facts & Figures 2021. Atlanta:
American Cancer Society; 2021. https://www.cancer.org/content/dam/
cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-
and-figures/2021/cancer-facts-and-figures-2021.pdf.
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CRC has a higher impact on communities of color. Specifically,
Black, and Native American individuals have the highest incidence of
CRC; Black Americans have the highest rate of CRC-related death, and
Latinos have CRC screening rates far below White and Black
Americans.\2\
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\2\ Balzora, S., Issaka, R. B., Anyane-Yeboa, A., Gray, D. M., 2nd,
& May, F. P. (2020). Impact of COVID-19 on colorectal cancer
disparities and the way forward. Gastrointestinal endoscopy, 92(4),
946-950. https://doi.org/10.1016/j.gie.2020.06.042.
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COVID-19's Impact on CRC Screenings
Screening can prevent colorectal cancer deaths by detecting
precancerous polyps early, allowing for early treatment and full
recovery. Unfortunately, as with other health care services, the COVID-
19 pandemic significantly reduced the volume of preventive screenings.
According to a report,\3\ CRC screenings were estimated to have dropped
by 86% in the first few months of the pandemic and have not yet fully
recovered.
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\3\ EPIC Health Research Network. Delayed Cancer Screenings-A
Second Look. Available at: https://ehrn.org/articles/delayed-cancer-
screenings-a-second-look/. pdf. Accessed May 17, 2021.
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With the drop in screenings, delay in diagnosis, lack of access to
care, abandonment of care, interruption or alteration in treatment and
job loss resulting in lapsed health insurance coverage etc., cancer
mortality rates across numerous cancers have increased. The National
Cancer Institute (NCI) estimates a 1% increase in deaths from breast
and colon cancer over the next 10 years, which equates to an additional
10,000 deaths due to the pandemic's impact on screening and
treatment.\4\
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\4\ Sharpless, N. E. (2020). COVID-19 and cancer. https://tcjl.com/
wp-content/uploads/2020/06/Science-COVID-19-and-Cancer-editorial-
copy.pdf.
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As communities across the U.S. fight the pandemic locally,
community-based health care facilities that typically would offer
cancer screenings and other preventative health services have
reallocated their limited resources and shifted workforce deployment to
address the pandemic. This reduction in cancer screening resources has
heightened the ongoing health care access issues that impact vulnerable
populations, and their worsening clinical outcomes. Specifically,
racial, and ethnic minority communities, who, including before the
pandemic, have lower rates of CRC screening and higher rates of
incidence and mortality from CRC.
Health disparities and CRC
Colorectal cancer (CRC) during the pandemic places a spotlight on
the health disparities and inequities stemming from social determinants
of health that continue to plague medically underserved populations.
COVID-19 cases, hospitalizations and deaths were highest among
communities of color, especially those with comorbidities like obesity,
diabetes, and asthma. Although screening rates are resuming, the rates
in minority communities likely still lag due to access, financial,
transportation and other socioeconomic factors exacerbated by the
pandemic.
The NIH resources spent on COVID-19 and health disparities have
been essential to better understand the long-term impact of the
pandemic on the medically underserved population in the U.S. To improve
CRC screening, prevention and treatment, AGA recognizes the continued
need to collect systemic data on the short and long-term outcomes of
COVID-19 and CRC disparities. Therefore, AGA urges the subcommittee to
include the following report language that would allow NIH to continue
its support of studies focused on CRC disparities heightened by the
COVID-19 pandemic.
COVID-19 Pandemic Impact on Colorectal Cancer Disparities.--Given
the impact that screening can have on reducing mortality and morbidity
in colorectal cancer (CRC), the Committee encourages the NIH to study
the impact of the COVID-19 pandemic on the incidence of CRC in minority
communities. The committee is hopeful that such information will
provide policymakers with a better understanding of the effects on
minority communities and help develop strategies to address barriers to
screening and reduce health inequities and cancer deaths.
On behalf of AGA, its members, and the GI community, I would like
to thank you for your consideration of this request. If you have any
questions, please contact Kathleen Teixeira, Vice President of
Government Affairs, at [email protected].
[This statement was submitted by Dr. Fola May, MD, PhD, MPhil,
Associate
Professor of Medicine, University of California, Los Angeles.]
______
Prepared Statement of the American Geophysical Union
The American Geophysical Union (AGU), a non-profit, non-partisan
scientific society, appreciates the opportunity to submit testimony
regarding the fiscal year (FY) 2022 appropriation for the National
Institute of Environmental Health Sciences (NIEHS). AGU, on behalf of
its community of 130,000 Earth and space scientists, respectfully
requests that the 117th Congress appropriate $875 million for the
NIEHS. AGU's appropriations request takes into consideration any
previous budget cuts is driven by the need for significant investment
in federal research and development to ensure that the U.S. remains at
the forefront of research and innovation.\1\
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\1\ This amount of growth is recommended by the Innovation: An
American Imperative statement, which was authored by nine large U.S.
corporations and endorsed by over 500 leading industry, higher
education, science, and engineering organizations from across the 50
states. https://innovation-imperative.herokuapp.com/index.html.
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Under the umbrella of the National Institutes of Health (NIH), the
NIEHS conducts essential, innovative research that advances our
understanding of the effects of environmental changes or exposures on
human health and disease in the U.S. and across the globe. Through
NIEHS research, policymakers have access to vital, unbiased science
that is necessary for making informed decisions when addressing public
health issues. A few examples of the NIEHS's invaluable work are
provided below.
Improving Disaster Response, Reducing Health Impacts, & Preventing
Future Harm
The NIH Disaster Research Response program, launched by the NIEHS
and the National Library of Medicine, helps to address the ongoing need
for time-sensitive research in the aftermath of disasters, such as
hurricanes, wildfires, oil spills, and public health crises. Such
research helps scientists, government agencies, and communities better
understand immediate environmental exposures and injury risks,
potential short-term and long-term health impacts, the effectiveness of
health response efforts and environmental cleanup efforts, as well as
factors affecting post-disaster recovery and resiliency to future
events. To support timely gathering of the environmental and toxicology
data needed, the program has readily available research protocols, data
collections tools, and training resources.\2\
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\2\ See, NIH Disaster Research Response Program (DR2), https://
dr2.nlm.nih.gov/.
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Increasing Knowledge of Health Effects Related to PFAS Exposure
The NIEHS continues to be at the forefront of research on
perfluoroalkyl and polyfluoroalkyl substances (PFAS). A couple of years
ago, at least 610 locations in 43 states were known to be affected by
PFAS contamination, which included drinking water systems serving an
estimated 19 million people.\3\ Research into the possible health
impacts of PFAS chemicals exposure has already unmasked many links to
adverse health outcomes. For example, research has revealed that PFAS
exposure may increase a woman's risk of pregnancy complications.\4\
However, there is still much to understand regarding the effects of
PFAS exposure, which is why the NIEHS continues to conduct research and
award grants to external organizations across the nation.
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\3\ Based on data analysis by the Environmental Working Group and
Northeastern University. Walker, B., (6 May 2019). Mapping the PFAS
contamination crisis: New data show 610 sites in 43 states, EWG News
and Analysis, https://www.ewg.org/news-and-analysis/2019/04/mapping-
pfas-contamination-crisis-new-data-show-610-sites-43-states.
\4\ Broadfoot, M., (February 2020). Replacement chemicals may put
pregnancies at risk. Environmental Factor, NIEHS Newsletter, https://
factor.niehs.nih.gov/2020/2/science-highlights/replacement/index.htm.
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Growing the Environmental Health Science Workforce
To further expand the world's understanding of environmental
impacts on human health and disease and support interdisciplinary
scientific research, the NIEHS provides training and educational
opportunities for students of all ages-from the high school and
undergraduate levels to graduate students and faculty. For example, the
NIEHS Medical Student Research Fellowship program provides medical
students an opportunity to train in environmental health-related
research for a year at the NIEHS.\5\ The NIEHS also awards NIH Summer
Research Experience Program (R25) grants that give high school and
college students and science teachers an opportunity to gain valuable
research experience at a higher education institution during the
summer.\6\
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\5\ See, NIEHS Medical Student Research Fellowships, https://
www.niehs.nih.gov/careers/research/med-students/index.cfm.
\6\ See, the NIH Summer Research Experience Programs (R25), https:/
/www.niehs.nih.gov/research/supported/irt/summer_research/index.cfm.
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conclusion
At a time when our nation is recovering and has many pressing
priorities that need to be addressed, the future of the U.S. will be
strengthened by strong and sustained investments in the full scope of
our research enterprise-including new, innovative research regarding
the impact of environmental factors on human health generated by the
NIEHS. AGU appreciates the Subcommittee's leadership in this area, as
well as the opportunity to submit this testimony. Thank you for your
thoughtful consideration of our request.
[This statement was submitted by Michael Villafranca, Senior
Specialist, Science Policy & Government Relations.]
______
Prepared Statement of the American Geriatrics Society
The American Geriatrics Society (AGS) greatly appreciates the
opportunity to submit this testimony. The AGS is a national non-profit
organization of nearly 6,000 geriatrics healthcare professionals and
basic and clinical researchers dedicated to improving the health,
independence, and quality of life of all older Americans. As the
Subcommittee works on its fiscal year (FY) 2021 Labor, Health and Human
Services, and Related Agencies Appropriations Bill, we ask that you
prioritize funding for the geriatrics education and training programs
under Title VII of the Public Health Service (PHS) Act, and for aging
research within the National Institutes of Health (NIH) and National
Institute on Aging (NIA).
We are appreciative of your ongoing support of the Title VII
Geriatrics Health Professions Programs at the Health Resources and
Services Agency (HRSA), which includes the Geriatrics Workforce
Enhancement Program (GWEP) and Geriatrics Academic Career Award (GACA)
program. However, the AGS believes it is urgent that we increase the
educational and training opportunities in geriatrics and gerontology
and ensure that HRSA receives the funding expansion necessary for these
critically important programs for the care and health of older adults.
We ask that the Subcommittee consider the following funding levels
for these programs in FY 2022:
--At least $105.7 million to support the GWEP and GACA program (PHS
Act Title VII, Sections 750 and 753(a))
--An increase of no less than $3.3 billion over the enacted FY 2021
level in the FY 2022 budget for total spending at NIH for
current institutes and operations; a minimum increase of $500
million to invest in biomedical, behavioral, and social
sciences aging research efforts across NIH; and a minimum
increase of $289 million for research on Alzheimer's disease
and related dementias over the enacted FY 2021 level in the FY
2022 budget
Sustained and enhanced federal investment in these initiatives is
essential to delivering high-quality, better coordinated, efficient,
and cost-effective care to our older Americans whose numbers are
projected to increase dramatically in the coming years. According to
the U.S. Census Bureau, the number of people age 65 and older is
projected to more than double from 54.1 million today \1\ to more than
94 million by 2060,\2\ while those 85 and older is projected to more
than triple from 6.4 million today to 19 million by 2060.\3\ As our
aging population increases, so too will the prevalence of diseases
disproportionately affecting older people--most notably Alzheimer's
disease and related dementias (including vascular, Lewy body, and
frontotemporal dementia)--and the economic burden associated with these
diseases.
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\1\ U.S. Census Bureau. 2019 American Community Survey 1-Year
Estimates Subject Tables. Available at https://data.census.gov/cedsci/
table?q=S0101&tid=ACSST1Y2019.S0101&hide
Preview=false.
\2\ U.S. Census Bureau. An Aging Nation: Projected Number of
Children and Older Adults. Available at https://www.census.gov/library/
visualizations/2018/comm/historic-first.html. Published March 13, 2018.
\3\ Ibid.
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To ensure that our nation is prepared to meet the unique healthcare
needs of this rapidly growing population, we request that Congress
provide additional investments necessary to expand and enhance the
geriatrics workforce, which is an integral component of the primary
care workforce, and to foster groundbreaking medical research.
programs to train geriatrics healthcare professionals
Geriatrics Workforce Enhancement Program and Geriatrics Academic Career
Award Program (at least $105.7 million)
Our healthcare workforce receives little, if any, training in
geriatric principles,\4\ which leaves us ill-prepared to care for older
Americans as health needs evolve, especially during the current COVID-
19 public health emergency. With our nation continuing to face a severe
shortage of geriatrics healthcare providers and academics with the
expertise to train these providers, the AGS believes it is urgent that
we increase the number of educational and training opportunities in
geriatrics and gerontology. The requested increase in funding over FY
2021 levels would help ensure that HRSA receives the funding necessary
to expand these critically important programs commensurate with the
increasing need.
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\4\ Only 3 percent of medical students take even one class in
geriatric medicine and fewer than 1 percent of RNs, pharmacists,
physician assistances and physical therapists are certified in
geriatrics or gerontology. Yet estimates are that by 2030, 3.5 million
additional health care professionals and direct-care workers will be
needed to care for older adults. 2018 Issue Brief, Eldercare Workforce
Alliance, Available at https://eldercareworkforce.org/wp-content/
uploads/2018/03/GWEP_OnePager_v2.pdf.
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The GWEP is currently the only federal program designed to increase
the number of providers, in a variety of disciplines, with the skills
and training to care for older adults. The GWEP awardees educate and
engage the broader frontline workforce, including family caregivers,
and focus on opportunities to improve the quality of care delivered to
older adults, particularly in underserved and rural areas. Due to
GWEPs' partnerships with primary care and community-based
organizations, GWEPs are uniquely positioned to rapidly address the
needs of older adults and their caregivers. The GWEP was launched in
2015 by HRSA with 44 three-year grants provided to awardees in 29
states. In 2019, HRSA funded a second cohort of 48 GWEPs across 35
states and two territories (Guam and Puerto Rico) and provided
extension grants to 15 former GWEP awardees.
The GACA program is an essential complement to the GWEP. GACAs
ensure we can equip early-career clinician educators to become leaders
in geriatrics education and research. It is the only federal program
designed to increase the number of faculty with geriatrics expertise in
a variety of disciplines. The program was eliminated in 2015 through a
consolidation of several training programs. However, the program was
reestablished in November 2018 when HRSA released a funding opportunity
indicating their intention to fund 26 GACAs for four years starting
September 1, 2019. Since 1998, original GACA recipients have trained as
many as 65,000 colleagues in geriatrics expertise and have contributed
to geriatrics education, research, and leadership across the U.S.
Most recently, the GWEPs and GACAs have been an asset for states as
many states and localities grapple with the rollout of the COVID-19
vaccine and address vaccine hesitancy. GWEPs have been staffing call
lines to assist older adults to register for the vaccine, advising
local authorities on making the sign-up websites age-friendly, and
working with health systems to participate in the rollout and outreach
to vulnerable and hard-to-reach populations, preventing widening the
health disparity gap exacerbated by the pandemic. Looking forward,
these programs will be critical in providing assistance for proactive
public health planning with their geriatrics expertise and knowledge of
long-term care and can help ensure states and local governments have
improved plans for older adults in disaster preparedness for future
pandemics and natural disasters. Furthermore, as the U.S. population
rapidly ages, access to a well-trained workforce and appropriate care
for medically complex older adults is imperative to maintaining the
health and quality of life for this growing segment of the nation's
population.
To address this issue, we ask the Subcommittee to provide a FY 2022
appropriation of at least $105.7 million for the GWEP and GACA program.
This increase in funding over FY 2021 levels would help ensure that
HRSA receives the funding necessary to carry these critically important
programs forward. Additional funding will also allow HRSA to expand the
number of GWEPs and GACAs and move towards closing the current
geographic and demographic gaps in geriatrics workforce training. As
laid out in President Biden's American Jobs Plan, the infrastructure of
care in the U.S. needs substantial investments so that access to long-
term services and supports is expanded while the healthcare workforce
is adequately supported and prepared to care for us all as we age.
research funding initiatives
National Institutes of Health/National Institute on Aging (additional
$500 million for aging research efforts and a minimum increase
of $289 million for Alzheimer's disease and related dementias
research)
The institutes that make up the NIH, and specifically the NIA, lead
the national scientific effort to understand the nature of aging and to
extend the healthy, active years of life. As a member of the Friends of
the NIA (FoNIA), a broad-based coalition of aging, disease, research,
and patient groups committed to the advancement of medical research
that affects millions of older Americans--the AGS urges you to include
an increase of at least $500 million in the FY 2022 budget for
biomedical, behavioral, and social sciences aging research efforts
across NIH and a minimum increase of $289 million for research on
Alzheimer's disease and related dementias over the enacted FY 2021
level.
The federal government spends a significant and increasing amount
of funds on healthcare costs associated with age-related diseases. By
2050, for example, the number of people age 65 and older affected by
dementia is estimated to reach 12.7 million cases--nearly double the
number in 2021--and is projected to cost $355 billion which does not
include the $256.7 billion in unpaid caregiving by family and
friends.\5\ Further, chronic diseases related to aging, such as
diabetes, heart disease, and cancer continue to afflict 80 percent of
people age 65 and older \6\ and account for more than 75 percent of
Medicare and other federal health expenditures.\7\ Continued and
increased federal investments in scientific research will ensure that
the NIH and NIA have the resources to conduct groundbreaking research
related to the aging process, foster the development of research and
clinical scientists in aging, provide research resources, and
communicate information about aging and advances in research on aging.
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\5\ Alzheimer's Association. 2021 Alzheimer's Disease Facts and
Figures. Alzheimers Dement. 2021; 17(3):327-406. https://doi.org/
10.1002/alz.12328.
\6\ National Prevention Council. Healthy Aging in Action: Advancing
the National Prevention Strategy. Available at https://www.cdc.gov/
aging/pdf/healthy-aging-in-action508.pdf. Published November 2016.
\7\ Erdem, E, Prada, SI, Haffer, SC. Medicare Payments: How Much Do
Chronic Conditions Matter?. Medicare & Medicaid Research Review.
2013;3(2). http://dx.doi.org/10.5600/mmrr.
003.02.b02.
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Additionally, the AGS supports no less than a $3.3 billion increase
over the enacted FY 2021 level in the FY 2022 budget for total spending
at NIH for current institutes and operations. We believe that a
meaningful increase in NIH-wide funding, in combination with aging and
increase in prevalence of diseases, will be essential to sustain the
research needed to make progress in addressing chronic disease,
Alzheimer's disease, and related dementias that disproportionately
affect older people.
Strong support such as yours will help ensure that every older
American is able to receive high-quality care. We greatly appreciate
the Subcommittee for the opportunity to submit this testimony.
______
Prepared Statement of the American Heart Association
Chair Murray, Ranking Member Blunt, and members of the
subcommittee, thank you for the opportunity to testify today. My name
is Dr. Keith Churchwell, and I am President of Yale New Haven Hospital
and a volunteer for the American Heart Association where I Chair the
National Advocacy Committee. As a cardiologist for over 25 years, a
hospital administrator who has worked in a number of roles across the
country to improve and expand care for our patients, along with more
than 20 years as a volunteer with the American Heart Association, I
understand firsthand the burden of heart disease as the world's leading
killer, and the importance of research and prevention.
I'm pleased to testify today on two specific opportunities to
improve Americans' health in the fiscal year (FY) 2022 Labor, Health
and Human Services, Education and Related Agencies appropriations bill.
I respectfully request you work over the next three years to triple the
budget of the Centers for Disease Control and Prevention (CDC) National
Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) to
$3.75 billion. I also respectfully request that, within this increase,
you provide $20 million in new funding to expand an existing COVID-19
Cardiovascular Disease (CVD) registry in partnership with NCCDPHP.
funding for the national center for chronic disease prevention and
health promotion
Chronic diseases represent 7 of the 10 leading causes of death,\1\
and account for 90% of the nation's $3.8 trillion in annual health care
costs.\2\ Heart disease remains the number one cause of death in the
United States, with approximately 655,000 individuals in America dying
from heart disease each year. In 2018, stroke accounted for about 1 of
every 19 deaths in the United States.\3\ Chronic diseases are best
managed by consistent access to health care services and treatments,
for example, a 10% increase in hypertension treatment could prevent
14,000 deaths each year.\4\
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\1\ Centers for Disease Control and Prevention. Leading causes of
death. Morality in the United States, 2019. Accessed online February
17, 2021.
\2\ Buttorff C, Ruder T, Bauman M. Multiple Chronic Conditions in
the United States. Santa Monica, CA: Rand Corp.; 2017 and Martin AB,
Hartman M, Lassman D, Catlin A. National Health Care Spending In 2019:
Steady Growth for The Fourth Consecutive Year. Health Aff.
2020;40(1):1-11.
\3\ Heart Disease and Stroke Statistics-2021 Update: A Report From
the American Heart Association https://www.ahajournals.org/doi/10.1161/
CIR.0000000000000950.
\4\ Call to Action: Urgent Challenges in Cardiovascular Disease: A
Presidential Advisory From the American Heart Association, Mark
McClellan, MD, PhD, Nancy Brown, BS, Robert M. Califf, MD, MACC, John
J. Warner, MD, FAHA (2019) https://www.ahajournals.org/doi/10.1161/
CIR.0000000000000652.
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My positions at Yale New Haven Hospital and the American Heart
Association have provided me a unique perspective on what individuals
and families need to prevent disease, cure illness, and manage chronic
health conditions, and I can personally attest to the importance of
cardiovascular disease prevention programs specifically supported by
the CDC. The burden of chronic disease is growing faster than our
ability to ameliorate the growth, putting an increasing strain on the
health care system, health care costs, our productivity, educational
outcomes, military readiness and well-being.\5\ Current funding for CDC
NCCDPHP falls far short of what is needed to prevent chronic disease,
slow its spread, and protect patients. The COVID-19 pandemic has only
exacerbated these challenges, and the underfunding of NCCDPHP has made
the nation more vulnerable to the pandemic. For example:
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\5\ Heidenreich PA, Trogdon JG, Khavjou OA, et al. Forecasting the
future of cardiovascular disease in the United States: a policy
statement from the American Heart Association. Circulation.
2011;123:933-944.
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--COVID-19 poses elevated health risks for people with chronic
conditions-including severe illness and death-and may lead to
heart failure, stroke, kidney failure, chronic lung disease,
blood pressure abnormalities, neurological conditions, and
other long-term health complications in people who have
survived the virus.
--Deaths from ischemic heart disease and hypertensive diseases in the
United States increased during the COVID-19 pandemic, while
globally, COVID-19 was associated with significant disruptions
in cardiovascular disease testing, diagnosis and timely
treatment.\6\
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\6\ COVID-19 Pandemic Indirectly Disrupted Health Disease Care.
American College of Cardiology. January 11, 2021. Accessed online
February 17, 2021.
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After more than a decade of stagnant funding, a congressional
commitment to triple CDC NCCDPHP's budget over the next three fiscal
years is long overdue to respond to the increasing threat chronic
diseases pose to Americans. A robust investment, appropriate to the
magnitude of the problem, will allow CDC NCCDPHP to fulfill its mission
by expanding the current patchwork of existing programs nationwide and
by implementing new programs to address emerging health challenges,
including the emerging chronic disease cohort of COVID-19 ``long-
haulers.''
covid-19 cardiovascular disease registry
Since the start of the pandemic, researchers have made great
advances in our knowledge of the disease characteristics, associated
health risks, and appropriate mitigation and treatment of COVID-19. We
have learned that COVID-19 has a disproportionate impact on patients
who face endemic inequities, such as lower paying and hourly wage jobs
deemed ``essential.'' Unstable or unsafe housing and decreased
availability of health care and insurance coverage also add to that
impact. COVID-19 has laid bare the health inequities that have long
affected communities of color in the United States as the burden of
COVID-19 remains higher among African Americans, American Indians/
Alaska Natives, Hispanics/Latinos, and Asian Americans and Pacific
Islanders, compared with whites.\7\
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\7\ Lopez L, Hart LH, Katz MH. Racial and Ethnic Health Disparities
Related to COVID-19. JAMA. 2021;325(8):719-720. https://
jamanetwork.com/journals/jama/fullarticle/2775687.
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In April 2020, the American Heart Association launched the COVID-19
Cardiovascular Disease (CVD) Registry, which captures data on
hospitalized COVID-19 patients' clinical characteristics, medications,
treatments, biomarkers and outcomes, and focuses on real-time, granular
data from acute care hospitals to better help clinicians and
researchers understand and provide feedback on how to best treat COVID-
19 patients. To date, the COVID-19 CVD Registry includes nearly 170
hospitals and health systems across 35 states, reporting more than
40,000 adult COVID-19 patient records. Approximately 50 percent of the
registry patients identify as Black or Hispanic, making the registry
representative of communities disproportionately affected by the
pandemic.
According to initial research based on the COVID-19 CVD registry
data, obese patients experienced some of the worst outcomes of all
patients hospitalized with COVID-19, including increased risks for
blood clots, the need for breathing assistance and dialysis, and death.
Research has already found that patients with COVID-19 who are
hospitalized with a stroke have worse outcomes than stroke patients
without COVID-19. We are also now beginning to understand the long-term
health implications of COVID-19 in the population referred to as
``long-haulers.'' These patients have an increased risk of developing
myocarditis, or inflammation of the heart, that can lead to heart
failure, thromboembolic disease or blood clots, and other lingering
health conditions.
Additional funding is needed to expand the registry infrastructure
nationally to enhance geographic representation for both urban and
rural hospitals. A more robust, representative registry will provide
clinicians and researchers with the tools to advance our understanding
of post-COVID syndromes and provide much needed insights into this new
chronic disease cohort. Once expanded, this registry also will provide
an at-the-ready, adaptable infrastructure to respond to new and
emerging public health threats. Therefore, within the new funding
provided to the CDC NCCDPHP, the American Heart Association
respectfully requests that the Committee provide $20 million to expand
the COVID-19 CVD registry nationwide to include hundreds more
hospitals-including sole community hospitals, safety net hospitals, and
disproportionate share hospitals-and support CDC NCCDPHP in collecting,
curating, analyzing, and publishing the registry data.
As the pandemic has demonstrated, chronic diseases and infectious
diseases are inextricably linked. Therefore, any efforts to improve
pandemic preparedness and prevent the spread of infectious disease must
also include efforts to prevent chronic disease, address health
disparities, and ultimately, improve underlying health and wellness for
all. A significant investment in NCCDPHP is essential to that goal. We
must make these investments if we are to preserve health, well-being,
productivity, and longevity for all in America. I thank you for the
opportunity to offer my perspective today, and for your continued
leadership.
______
Prepared Statement of the American Indian Higher Education Consortium
On behalf of the nation's 37 Tribal Colleges and Universities
(TCUs), which collectively are the American Indian Higher Education
Consortium (AIHEC), we thank you for the opportunity to share our FY
2022 funding requests. The following is a list of recommendations
including Department, program, and funding requests.
Department of Education--Office of Postsecondary Education
--Strengthening Institutions HEA Title III--Part A (Sec. 316):
$53,080,000 (discretionary)
--Perkins Career and Technical Education Programs (Sec. 117):
$15,000,000
Department of Education--Office of Indian Education
--Indian Education Professional Development Program: $20,000,000
Department of Health and Human Services
--Administration for Children and Families/Office of Head Start
TCU-Head Start Partnership Program: $8,000,000 in existing funds
Tribal Colleges and Universities: Serving Students Across Indian
Country and Rural America
Currently, 37 TCUs operate more than 75 campuses and sites in 16
states. TCU geographic boundaries encompass 80 percent of American
Indian reservations and federal Indian trust lands. American Indian and
Alaska Native (AI/AN) TCU students represent more than 230 federally
recognized Tribes and hail from more than 30 states. Nearly 80 percent
of these students receive federal financial aid, and nearly half are
first generation students. In total, TCUs serve over 160,000 American
Indians, Alaska Natives, and other rural residents each year through a
wide variety of academic and community-based programs. Funding cuts of
any amount to even one TCU program would force TCUs to scale back vital
programs and services that students rely on to complete degree and
certificate programs needed to succeed in their chosen career paths.
Any reduction in funding will threaten TCU accreditation status and
will further stretch overtaxed faculty and staff or result in cuts to
faculty and staff. The following are justifications for TCU FY 2022
funding requests.
u.s. department of education
Strengthening Tribal Colleges (HEA Title III--Part A--Section 316):
TCUs urge the Subcommittee to provide $53,080,0000 for the
Strengthening Tribal Colleges program (HEA Title III-Part A). The
Strengthening Institutions HEA Title III program for TCUs (Section 316)
is specifically designed to address the critical, unmet needs of AI/AN
students and their communities. Through this program, TCUs are able to
provide student support services, Native language preservation, basic
upkeep of campus buildings and infrastructure, critical campus
expansion, enterprise management systems, faculty for core courses, and
other necessary elements for a quality educational experience. The
Strengthening Institutions program provides formula-based aid to 35
TCUs through two funding sources: Part A discretionary funding (FY
2021, $38.08 million) and Part F mandatory funding (FY 2020, $28.2
million). In 2019, TCUs feared losing nearly half of Title III funding
with the anticipated expiration of Part F funding. Fortunately, the
``Fostering Undergraduate Talent by Unlocking Resources to Education
Act (P.L. 116-91) was signed into law on December 20, 2019, permanently
authorizing Part F mandatory funding at $30 million for TCUs. Part A
and Part F of the Title III program are essential in supporting
institutional development and student services. AIHEC strongly supports
the President Budget Request for FY 2022, and we urge the Subcommittee
to fund these programs at the President's requested levels: HEA Title
III Part A (discretionary funding) at $53,080,000 and HEA Title III
Part F (mandatory funding) at $89,000,000.
Carl D. Perkins Career and Technical Education Programs
Tribally Controlled Postsecondary Career and Technical
Institutions: AIHEC requests $15,000,000 to fund grants under Sec. 117
of the Perkins Act. Carl D. Perkins Career and Technical Education Act
provides a competitively awarded grant opportunity for Tribally
chartered career and technical institutions (Sec.117), which provide
critical workforce development and job creation, education, and
training programs to AI/ANs from Tribes and communities with some of
the highest unemployment rates in the nation.
Native American Career and Technical Education Program (NACTEP):
NACTEP (Sec. 116) reserves 1.25 percent of appropriated funding to
support AI/AN career and technical programs. The TCUs strongly urge the
Subcommittee to continue to support NACTEP, which is vital to the
continuation of career and technical education programs offered at TCUs
that provide job training and certifications to remote reservation
communities.
Office of Indian Education
Indian Education Professional Development Program: AIHEC requests
$20,000,000 for grants to TCUs and other institutions of higher
education. The Indian Education Professional Development Program,
administered by the Office of Indian Education at the U.S. Department
of Education, provides grants to institutions of higher education to
prepare and train AI/ANs to serve as teachers and school administrators
at elementary and secondary schools. There is a growing teacher
shortage across the country, especially in urban and rural communities
with high AI/AN populations, where teacher recruitment and retention
pose unique challenges. In communities with teacher shortages, existing
obstacles to student success such as inadequate facilities and limited
broadband are further compounded by overcrowded classrooms. Targeted
resources like the Indian Education Professional Development Program
help address this shortage and ensure that AI/AN students receive high-
quality elementary and secondary education.
Report Language Needed: Funding for two distinct activities is
provided under the ``Special Programs for Indian Children'' account:
the Indian Education Professional Develop Program and Native Youth
Community Projects. Despite increased funding in 2016 to the overall
account, increases were only provided to Native Youth Community
Projects; the Indian Education Professional Development Program did not
receive increased funding. In FY 2020, the Special Programs for Indian
Children account received $67,993,000, of which $13,668,000 was
allocated for the Indian Education Professional Development Program.
AIHEC requests specific report language in order to increase funding
for the Indian Education Professional Development Program, at a minimum
of $20,000,000 in FY 2022.
u.s. department of health and human services programs
Administration for Children and Families--Office of Head Start:
Tribal Colleges and Universities Head Start Partnership Program: AIHEC
requests $8,000,000 for the TCU-Head Start Partnership program. The
TCU-Head Start Partnership program was re-established with the
designation of $4,000,000 within the FY 2020 LHHS appropriations bill
and continued with $4,000,000 within the FY 2021 LHHS appropriations
bill. TCUs have had marked success in training early childhood
educators and Head Start teachers who are urgently needed across Indian
Country. In 2017, 74.5 percent of Head Start teachers nationwide held a
bachelor's degree as required by federal law; but less than 42 percent
of Head Start teachers met the requirement in Indian Country (Head
Start Region 11); only 70 percent of workers in Region 11 met the
associate-level requirements or were enrolled in associate's degree
programs, compared to 90 percent nationally. TCUs are the most cost-
effective way for filling this gap. From 2000 to 2007, the U.S.
Department of Health and Human Services provided modest funding for the
TCU-Head Start Program (42 U.S.C. 9843g), which helped TCUs build
capacity in early childhood education by providing scholarships and
stipends for Indian Head Start teachers and teacher aides to enroll in
TCU early childhood/elementary education programs. Before the program
ended in 2007 (ironically, the same year that Congress specifically
authorized the program in the reauthorization of the Head Start Act),
TCUs had trained more than 400 Head Start workers and teachers, many of
whom have since left for higher paying jobs in elementary schools.
Today, TCUs such as Salish Kootenai College (Pablo, MT) are providing
culturally based early childhood education free of charge to local Head
Start professionals. In Michigan, Bay Mills Community College provides
online education programming for $50/credit to Head Start staff
nationwide. However, many Head Start programs in Indian Country are
paying far more for other sources to provide training. With the
restoration and continuation of this modestly funded program, TCUs can
aid in building an early childhood education workforce to better serve
the education needs of AI/AN children.
Substance Abuse and Mental Health Services Administration (SAMHSA)
NEW Tribal College and University Centers for Excellence in
Behavioral Health/Substance Abuse Prevention: AIHEC requests
$10,000,000 to establish this program. The goal of the TCU Centers of
Excellence program, similar to an existing SAMHSA program for HBCUs, is
to grow a highly skilled and culturally competent AI/AN behavioral
health workforce by developing an apprenticeship-based network of TCUs
and partners from the health industry and local, Tribal, state, and
regional providers. The TCU Centers of Excellence would share best
practices in curriculum development, program implementation, and
apprenticeships; recruit students to careers in behavioral health
fields to address mental and substance use disorders; provide job
training in behavioral health fields; and prepare students to earn
credentials in behavioral health fields. The TCU Centers of Excellence
would emphasize education, awareness, workforce training, and
preparation for careers in mental and substance use treatment,
prevention, and research, including addressing opioid abuse prevention,
opioid use disorder treatment, serious mental illness, and suicide
prevention.
conclusion
Tribal Colleges and Universities provide thousands of AI/AN
students with access to high-quality, culturally appropriate,
postsecondary education opportunities, including critical early
childhood education and behavioral health programs. The modest federal
investment in TCUs has paid great dividends in terms of employment,
education, and economic development. We ask you to renew your
commitment to help move our students and communities toward self-
sufficiency and request your full consideration of our FY 2022
appropriations requests. Thank you.
______
Prepared Statement of the American Liver Foundation
summary of fiscal year 2022 appropriations recommendations
_______________________________________________________________________
--Provide the National Institutes of Health (NIH) with at least $46.1
billion and provide individual NIH Institutes and Centers, such
as NIDDK, NIMHD, and NCI with proportional discretionary
increases.
--Please support establishment and adequate funding for the new
Advanced Research Projects Agency for Health (ARPA-H) at
NIH as proposed in the Administration's Budget Request to
Congress to facilitate robust scientific progress on
cancers and other conditions.
--Provide the Centers for Disease Control and Prevention (CDC) with
at least $10 billion to facilitate timely public health efforts
along with proportional increases for CDC Centers and
Divisions, such as NCCDPHP and NCHHSTP.
--Please provide $134 million for the Division of Viral Hepatitis
at CDC.
--Please provide $120 million for the Opioid and Infectious
Diseases Program at CDC.
--Please provide $5 million for the new Chronic Disease Education
and Awareness Program at CDC.
--Provide the Health Resources and Services Administration (HRSA)
with a funding level of at least $9.2 billion and ensure that
the agency has sufficient resources to enhance organ donation
through awareness activities and partnerships.
--Please support timely committee recommendations on liver diseases
and health disparities, NASH/NAFLD, organ donation, and related
areas.
_______________________________________________________________________
Thank you for the opportunity to submit testimony on behalf of the
American Liver Foundation (ALF) and the liver disease community.
Chairwoman Murray, Ranking Member Blunt, and distinguished members of
the subcommittee, we extend our thanks for the significant investments
in HHS, particularly NIH, provided over recent years. Please maintain
this commitment and further enhances support for public health programs
as you work on appropriations for Fiscal Year (FY) 2022. Thank you
again.
about the foundation
Founded in 1976, the American Liver Foundation (ALF) is the
nation's largest patient advocacy organization for people with liver
disease. ALF reaches more than?4?million individuals each year with
health information, education and support services via its national
office and an active online presence. Recognized as a trusted voice for
liver disease patients, ALF also operates a national toll-free helpline
(800-GO-LIVER), educates patients, policymakers and the public, and
provides grants to early-career researchers to help find a cure for all
liver diseases. ALF is celebrating more than 40 years of turning
patients into survivors. For more information about ALF, please visit
liverfoundation.org.
liver facts
The liver is one of the body's largest organs, performing hundreds
of functions daily including, removal of harmful substances from the
blood, digestion of fat, and storing of energy. Non-alcoholic fatty
liver disease (NAFLD), hepatitis C, and heavy alcohol consumption are
the most common causes of chronic liver disease or cirrhosis (severe
liver damage) in the U.S. Approximately 30% of adults and 3-10% of
children have excessive fat in the liver or NAFLD which can lead to a
severe liver disease called non-alcoholic steatohepatitis (NASH).
Approximately 4.4 million Americans are living with Hepatitis B or C
but most do not know they are infected. More than 2 million Americans
are living with alcohol related liver disease. Approximately 5.5
million Americans are living with chronic liver disease or cirrhosis.
Vaccinations for hepatitis A and B and treatments for hepatitis C are
helping to change the course of this chronic life altering disease for
the patient community.
cdc chronic disease education & awareness program
Thank you for establishing the CDC Chronic Disease Education &
Awareness Program in FY 2021 and providing $1.5 million in initial
support. Many patient organizations seek valuable collaborations with
CDC that can directly impact patients and improve public health. A few
contemporary examples include raising awareness of NASH/NAFLD, and
sharing public health information that can slow or stop the progression
of various liver conditions into liver cancer. This new program
provides a competitive mechanism that allows CDC to award meritorious
cooperative agreements on an annual basis. Since there is tremendous
demand in this area, and no shortage of quality opportunities for CDC,
we ask that funding be systematically increased with $5 million
provided for FY 2022.
organ donation
Consistently, the number of organs available for transplantation on
an annual basis amounts to only a fraction of the number of patients on
the transplant list. Compounding this situation is the fact that fatty
liver disease affects a large and growing number of individuals and
makes livers unavailable for transplantation. Another complicating
factor is the fact that the rationing of cures for hepatitis ensures
that many patients who could otherwise be healthy end up on the
transplant list too and arbitrarily deny available organs to other
patients facing a variety of life-threatening illnesses. Please promote
organ donation and otherwise work to ensure Medicaid and other patients
impacted by hepatitis receive curative therapy when medically
appropriate.
the opioid epidemic
CDC has dubbed opioids and the infectious diseases that arrive in
the wake of the opioid crisis a ``dual epidemic''. This epidemic has
been further fueled by the well-documents rise in opioid abuse during
the COVID-19 pandemic. Due to the ongoing increase in rates of
injection drug use, CDC recently identified a 400% increase in rates of
hepatitis C among 20--29 year olds an 300% increase among 30--39 year
olds. A few years ago, the elimination initiative was established at
CDC, and the current funding level is $13 million. We ask that this
allocation be systematically increased along with the annual funding
for the Division of Viral Hepatitis to ensure CDC has adequate
resources to make progress.
covid-19 and liver diseases
There is a growing body of work focused on COVID-19's impact on the
liver and persistent impacts for COVID ``long haulers''. We appreciate
that a well-resourced NIH and public health response can continue to
advance research in this critical area. Moreover, in regards to
vaccination, please note that the American Association for the Study of
Liver Diseases (AASLD) recommends that providers advocate for
prioritizing patients with compensated or decompensated cirrhosis or
liver cancer, patients receiving immunosuppression such as SOT
recipients, and living liver donors for COVID-19 vaccination based upon
local health policies, protocols, and vaccine availability.
nash bill of rights
Nonalcoholic steatohepatitis or NASH is liver inflammation and
damage caused by a buildup of fat in the liver. The prevalence of NASH
has been rising and innovative treatment options have been coming to
market along with improved healthcare. To better serve patients, ALF
crafted a NASH Patient Bill of Rights that provides critical
information on non-invasive testing options and coordinating
multidisciplinary healthcare. The Foundation looks forward to working
with the U.S. Public Health Services to disseminate critical
information about NASH to patients and providers.
patient perspectives
(Alison).--Alison is now a healthy 25-year-old from Trumbull,
Connecticut, only five years ago she was near death. Alison had been
suffering for most of her life with primary sclerosing cholangitis
(PSC), a condition that left her in need of a live-saving liver
transplant. On October 19th, 2009, Alison began her new life when her
transplant was successfully performed at Yale-New Haven Hospital.
Further complications ensued. Alison needed three additional surgeries
to ensure her health and that of her new liver. Today, she is healthy.
(Kevin).--In May 2007, a medical team at New York Columbia
Presbyterian Hospital conducted its first living donor liver transplant
surgery on a bile duct cancer patient. The patient was Kevin, my
younger brother. I was the living donor. The transplant worked, but
Kevin had to endure multiple follow-up surgeries to address a bile
leakage that would not stop. But now, over ten years later, he has long
since healed and doing great. We were lucky. And we know it. Despite
advances in medical and surgical science, the demand for organs
continues to vastly exceed the number of donors. Here, in New York,
only 27% of people age 18 and over have enrolled in the New York State
Donate Life Registry. But every ten minutes another person is added to
the national transplant waiting list. We need to encourage more people
to sign up to donate organs.
(David).--In October 2014 my mother Geraldine passed away after a
very brief and completely unexpected battle with late-stage NASH. They
call NASH the ``silent killer'' and in Mom's case it was certainly
true; she was never diagnosed with any form of liver disease at all
before NASH. We had noticed some yellowing of her eyes and convinced
her to go to the doctor about a month earlier, but it took time to get
an appointment with a specialist, who checked her into a hospital upon
the visit. I founded NASHAWARE.com to help raise awareness and educate
others. If I can help even a few people it will all be worth it. But I
still want to do much more.
[This statement was submitted by Lorraine Stiehl, Chief Executive
Officer,
American Liver Foundation.]
______
Prepared Statement of the American Lung Association
summary of fiscal year 2022 appropriations recommendations
_______________________________________________________________________
$10 billion for the Centers for Disease Control and Prevention (CDC)
--National Center for Chronic Disease Prevention & Health Promotion
(NCCDPHP)
Provide $3.75 billion for NCCDPHP
-- Provide $310 million for CDC's Office of Smoking and Health
(OSH)
-- Provide $5 million for CDC's Chronic Disease Education and
Awareness Program
--National Immunization Program at CDC's National Center for
Immunization and Respiratory Diseases (NCIRD)
Provide $1.13 billion for NCIRD
--National Center for Environmental Health (NCEH)
Provide $322 million for NCEH
-- Provide $110 million for CDC's Climate and Health Program
-- Provide $35 million for CDC's National Asthma Control Program
(NACP)
$46.1 billion for the National Institutes of Health (NIH)
--Provide $3.94 billion for the National Heart, Lung, and Blood
Institute
--Support establishment of, and adequate funding for, the new
Advanced Research Projects Agency for Health (ARPA-H) at NIH
_______________________________________________________________________
The American Lung Association is the leading public health
organization working to save lives by improving lung health and
preventing lung disease through education, advocacy and research.
Chairwoman DeLauro, Ranking Member Cole, and distinguished members of
the subcommittee, we extend our thanks for the significant investments
in the Department of Health and Human Service (HHS), including the
robust response to the COVID-19 pandemic. Please maintain this
commitment and further enhance support for public health programs as
you work on appropriations for Fiscal Year (FY) 2022. The American Lung
Association also asks for your leadership in opposing all policy riders
that would weaken key lung health protections.
The COVID-19 pandemic has underscored the need for significant and
sustained investments in our nation's public health infrastructure,
especially at CDC. For years, the Lung Association has requested for
robust CDC funding. Unfortunately, funding for CDC has remained
stagnant, and the failure to adequately invest has become evident
during the public health emergency that has taken the lives of over a
half a million people in the US. We ask that CDC funding be increased
to at least $10 billion for fiscal year 2022. This funding must be in
addition to, not in lieu of, emergency funds to respond to the current
pandemic.
The COVID-19 pandemic has also highlighted the importance of
preventing and managing chronic lung conditions. Individuals living
with certain lung diseases and people who smoke are among the most at
risk for severe illness from COVID-19. Research also shows that long-
term exposure to air pollution leads to worse COVID-19 outcomes. The
Lung Association recognizes the tremendous challenges Congress has
faced in responding to the pandemic and appreciates all that it has
done thus far. Continued investment in CDC programs that help smokers
quit; promote asthma control; support prevention and treatment of lung
and other chronic diseases, including chronic obstructive pulmonary
disorder (COPD) and lung cancer; and prepare for and respond to the
health impacts created by a warming climate is vital.
The American Lung Association strongly supports substantial federal
investments in key public health and biomedical research activities,
especially at CDC and NIH, respectively. For FY22, the Lung Association
encourages Congress to take a balanced approach in its increases for
these vital agencies and urges Congress to make significant investments
in public health programs at CDC.
Provide $10 billion for the Centers for Disease Control and
Prevention (CDC): The nation is relying on CDC more than ever before.
CDC is faced with unprecedented challenges and responsibilities,
especially in the respiratory space. Consequently, the American Lung
Association strongly supports the CDC Coalition's request of $10
billion for CDC for FY22 and sustained, robust and predictable funding
moving forward annually.
Provide $3.75 billion for National Center for Chronic Disease
Prevention and Health Promotion (NCCDPHP): In 2019, COPD was one of
seven chronic diseases included in the top 10 causes of death in the
United States. Chronic diseases can be prevented and/or managed through
supportive public health interventions including tobacco prevention and
cessation; however, they continue to be a major problem in the United
States. Over 90% of the nation's $3.8 trillion in annual health care
costs result from chronic diseases. The American Lung Association
strongly supports tripling the NCCDPHP budget over three years (FY22-
FY24). Such funding will allow NCCDPHP to fulfill its mission by
expanding the current patchwork of existing programs to all
jurisdictions nationwide and by implementing new efforts to address
health challenges currently without programs, including the chronic
disease cohort of COVID-19 ``long-haulers.'' It will also enable a
significant investment in CDC's Social Determinants of Health (SDOH)
program, which seeks to work with communities to identify and remedy
SDOH.
Provide $310 million for CDC's Office of Smoking and Health (OSH):
One in four high school students continues to use at least one tobacco
product. OSH is the lead federal agency for tobacco prevention and
control. The American Lung Association is appreciative of the $7.5
million increase in funding for OSH in FY21 and asks for an additional
$72.5 million for FY22. The additional funding will be used to continue
to address the e-cigarette pandemic, to enhance the ``Tips from Former
Smokers'' campaign so that it can be run year-round, to invest in youth
prevention efforts and to work to eliminate health inequities among
racial, ethnic, sexual, rural and socio-economic groups.
Provide $5 million for CDC's Chronic Disease Education and
Awareness Program: Far too many individuals in the United States have
or are at risk of potentially devastating chronic diseases without
knowing. COPD is one of the leading causes of death and disability in
the United States. Approximately 16 million people in the United States
have COPD, and millions more remain undiagnosed. Given this significant
gap in knowledge, the Lung Association greatly appreciates the creation
and funding of the Chronic Disease Education and Awareness competitive
grant program at CDC in FY21. In FY22, the Lung Association asks for
this program to be increased to $5 million to continue the momentum and
allow CDC to expand its work with stakeholders to respond to chronic
diseases, such as COPD, that do not have standalone programs.
Provide $110 million for CDC's Climate and Health Program: CDC's
Climate and Health Program is the only HHS program devoted to
identifying the risks and developing effective responses to the health
impacts of climate change (which include worsening air pollution;
diseases that emerge in new areas; stronger and longer heat waves; and
more frequent and severe droughts and wildfires) and provides guidance
to states in adaptation. Currently, projects in 16 states and two city
health departments develop and implement health adaptation plans and
address gaps in critical public health functions and services.
Unfortunately, the level of investment thus far has been insufficient
for this program to reach its full, possibly lifesaving, potential. The
President's budget requests $110 million, which would allow CDC to
implement a 50-state climate and health program.
Provide $35 million for CDC's National Asthma Control Program
(NACP): It is estimated that 24.8 million Americans currently have
asthma, of whom 5.5 million are children. The NACP tracks asthma
prevalence promotes asthma control and prevention and builds capacity
in states. This program has been highly effective: asthma mortality
rates have decreased despite the rate of asthma increasing. Additional
funding would allow approximately four to five additional states beyond
the current 25 states and localities to be funded to implement these
lifesaving programs.
Provide $1.13 billion for the National Immunization Program at
CDC's National Center for Immunization and Respiratory Diseases
(NCIRD): The success of the nation's vaccination programs has enabled
many individuals to forget about the impact of many vaccine preventable
diseases, such as polio, that once wreaked havoc. The COVID-19
pandemic, however, has provided a stark reminder of the need and
significance of vaccines and a robust national vaccination program. The
National Immunization Program must receive strong and sustained
funding. The Lung Association asks for $1.13 billion for NCIRD to
enhance COVID19 vaccinations, bolster the nation's immunization
infrastructure and address any gaps in routine immunizations that may
have emerged as a result of the pandemic.
Provide $46.1 billion for the National Institutes of Health (NIH):
The Lung Association supports increased funding for NIH research on the
prevention, diagnosis, treatment and cures for tobacco use and all lung
diseases including lung cancer, asthma, COPD, pulmonary fibrosis,
influenza and tuberculosis. The Lung Association also supports robust
funding increases for the individual institutes within NIH, recognizing
the need for research funding increases to ensure the pace of research
is maintained across NIH. Lastly, the Lung Association urges increased
funding for lung cancer research in addition to the Cancer Moonshot and
the All of Us Program.
Thank you for your consideration of our recommendations. Below
please find a vignette demonstrating the importance of CDC programs.
sharon l. from oklahoma: lung cancer & covid-19 survivor
``I now live with cancer. I am not a cancer patient; I am a patient who
has cancer.''
Sharon was diagnosed with Stage 4 lung cancer in October 2015.
After six rounds of aggressive chemotherapy, followed by another two
rounds shortly thereafter, Sharon is currently six years out from her
diagnosis and living without the need for additional treatment. This
past year, Sharon became one of the over 32 million individuals in the
United States diagnosed with COVID-19.
``I can't emphasize how important funding for the CDC is. Having
had COVID, it is even more important, but it has always been important
to me.''
Sharon and husband tenaciously fought to quit smoking, her husband
with the help of a CDC-funded quitline, and they were ultimately
successful in doing so. From her experiences, Sharon believes that
public health programs are critical to raising awareness about lung
cancer prevention and increasing tobacco cessation.
``What the CDC does with smoking cessation is vitally important, so
people don't end up like me, thinking they have 14 months to live and
watching every plan they have for growing old with their husband flash
before their eyes. It is vitally important. Public health is important
for everybody. You either pay for it now, or you pay for it at the end.
And it always costs more at the back end than now.''
michigan asthma prevention and control program (miapcp)
Michigan is one of the 23 states that receive funding through the
National Asthma Control Program (NACP). Through funding from CDC,
Michigan was able to create the Asthma Initiative of Michigan website,
www.GetAsthmaHelp.org, which enables access to a plethora of resources
for those struggling with asthma. The MiAPCP has also worked to
facilitate and support Managing Asthma Through Case-Management in Homes
(MATCH) throughout parts of Michigan with the highest burden of asthma.
Through MATCH programs, individuals can benefit from home visits, an
environmental assessment, access to a certified asthma educator, and a
physician care conference. As a result, Michigan saw a 60% decrease in
asthma-related emergency room visits, 82% decrease in hospitalizations
and a 58% decrease in the number of children who missed one or more
school days due to asthma.
``Interventions and policy efforts by our program that impact
asthma care and environments cannot be sustained without CDC's
support.''
--John Dowling, Lead Asthma Coordinator of the MiAPCP
Most recently, MiAPCP launched a cohesive effort to improve asthma
surveillance and data collection.
[This statement was submitted by Harold P. Wimmer, National
President and CEO, American Lung Association.]
______
Prepared Statement of the American Massage Therapy Association
The American Massage Therapy Association (AMTA) appreciates the
opportunity to submit written testimony for the record to the Senate
Subcommittee on Labor, Health and Human Services, and Education
Subcommittee in support of continued robust funding in FY 2022 for the
National Center for Complementary and Integrative Health (NCCIH) within
the National Institutes of Health (NIH) as well as for suggested report
language for both NCCIH as well as the Centers for Disease Control
(CDC).
Established in 1943 and numbering over 95,00 members, AMTA works to
advance the massage therapy profession through the promotion of fair
and consistent licensing of massage therapists in all states, public
education on the benefits of massage therapy, and support of research
to advance knowledge about massage therapy. Massage therapists are
currently licensed in 46 states and the District of Columbia.
We appreciate and acknowledge the Committee's ongoing support for
massage therapy, including past report language urging the adoption of
recommendations from the groundbreaking and widely supported 2019 HHS
final report from the Pain Management Best Practices Task Force (Task
Force). Unfortunately, most recommendations from that task force--
including those that support inclusion of massage therapy and other
integrative and complementary health treatments for pain--have still
not been adopted.
COVID-19 has exacerbated the already existing public health crisis
of acute and chronic pain from delayed access to health care, as well
as a rise in substance abuse and overreliance on opioids. We encourage
the Committee to include report language in the FY 2022 bill that
focuses on the need for greater public awareness on treatment options
for pain that include complementary and integrative approaches such as
massage therapy. We request the Committee to direct NIH to coordinate
with the DoD and VA to launch a much-needed public awareness campaign
about these non-opioid treatment options and to widely disseminate the
Task Force recommendations to health care providers and public health
stakeholders. Last, we request the Committee's continued support to
direct all relevant HHS agencies to update their pain management
practices to reflect the Task Force recommendations, including those
that support massage therapy.
We also support the inclusion of report language accompanying the
FY 2022 bill that would direct the CDC to collect and publish
population research data that provides a comprehensive assessment of
the nature of pain management, who is affected by pain, and direct and
indirect costs to society related to pain.
Over recent years, research continues to increase support for
massage therapy, which has thus increased policymakers' awareness of
the benefits of massage therapy as a non-pharmacologic alternative to
opioid use to manage pain. As noted above, massage is specifically
addressed throughout the 2019 Task Force report and is even included in
the Task Force ``Pain Management Toolbox'' as an example of a treatment
modality that should be considered as part of an overall integrative
and collaborative care model to ensure optimal patient outcomes.
https://www.hhs.gov/sites/default/files/pmtf-final-report-2019-05-
23.pdf. NCCIH notes the value of massage therapy for a wide variety of
health conditions involving both acute and chronic pain, including low
back pain, neck and shoulder pain, symptoms and side effects associated
with certain cancers, fibromyalgia, HIV/AIDS, among others.
In addition to NIH, massage therapy is supported by the American
College of Physicians and The Joint Commission. Massage is currently
utilized in many nationally renowned hospitals and other institutions,
such as the Mayo Clinic, M.D. Anderson Cancer Center, Duke Integrative
Medicine, the Cleveland Clinic, and Memorial Sloan Kettering Cancer
Center. Finally, CMS includes massage therapy provided by a state
licensed massage therapist as a supplemental benefit for pain
management in Medicare Advantage plans, and massage is also a covered
benefit for our nation's veterans and active-duty military personnel.
Despite the demonstrated value and efficacy of massage therapy
through research, we know that more needs to be done. As recently as
last August, a national survey of 1,581 people with pain indicated that
massage therapy is the most desired treatment for pain (at 48.4%,
followed by pain physician at 32.9% and acupuncture at 29%), but
unfortunately a majority of those surveyed indicated that cost
prevented them accessing massage therapy. This underscores the
disconnect between the best practices that already exist in pain
management and those that are realistically available to patients, due
to cost and lack of 3rd party insurance coverage, as well as
insufficient provider awareness of the benefits of massage and other
complementary therapies.
For over 30 years, the Massage Therapy Foundation (MTF) a 501(c)
(3) organization, working with AMTA, has provided over $1 million in
research grants studying the science behind therapeutic massage. This
seed money has funded needed research on a wide range of topics
including: the benefits of massage therapy for pediatric populations,
patients with heart failure, and those with muscle atrophy, among
others. Many of these efforts have been specifically designed to
include racially diverse and underserved populations.
We know that massage therapy can improve health outcomes and is
also among the most cost-effective therapies that can save health care
expenditures in the long run. Massage therapy demonstrably reduces or
mitigates reliance on opioids to address pain. Massage therapy can
serve as a 'portal' to increase patient involvement in other important
health activities, e.g. research shows that patients who obtain massage
are more likely to be able to move better, and thus engage in other
physician-prescribed activities such as corrective exercise programs.
We encourage a sustained and robust finding stream for NIH and
NCCIH that supports the role of integrative therapies to help mitigate
opioid abuse and misuse, and which will enable continued advancements
in the use of non-pharmacologic therapies such as massage.
Thank you for your consideration, and AMTA would be happy to
provide more information as needed.
Sincerely,
James Specker, AMTA Director, Industry and Government Relations at
[email protected].
______
Prepared Statement of the American National Red Cross and
the United Nations Foundation
Chairwoman Patty Murray, Ranking Member Roy Blunt, and Members of
the Subcommittee on Labor, Health and Human Services, Education and
Related Agencies, the American Red Cross and the United Nations
Foundation appreciate the opportunity to submit testimony. We are
writing to request that Congress invest $60 million for CDC's global
measles and rubella elimination efforts for fiscal year 2022.
The American Red Cross and United Nations Foundation recognize the
leadership that Congress has shown in funding CDC in prior years and
urge Congress to protect the CDC's funding necessary for their global
measles elimination activities for FY2022 at $60 million, which is part
of the overall Global Immunization Division line.
covid-19 environment
COVID-19 has had an unprecedented impact on global immunization
programs. As of June 1st twenty-three measles and rubella vaccination
campaigns that were scheduled for 2020 continue to be postponed as a
result of the COVID-19 pandemic, leaving an estimated one hundred and
thirty-five million children unvaccinated and vulnerable to the
diseases. This growing immunity gap is creating a looming cliff in
global public health, as social distancing measures are lowered, the
measles virus will quickly spread amongst unvaccinated individuals and
communities. Because the measles virus is one of the most transmissible
human viruses--with each infectious person capable of infecting as many
as 18 unvaccinated individuals--a drastic increase in measles outbreaks
around the world is anticipated. Failing to close these immunity gaps
will leave millions of children at risk and will compromise U.S. global
health security by disrupting economies, trade, and country stability,
and increasing the likelihood of the virus infecting U.S. communities.
Investments that will quickly close these global immunity gaps will
help to ensure that gains made in reducing maternal and child mortality
and morbidity are maintained, and that the global health infrastructure
established through these investments is preserved and strengthened.
Among other benefits, this global health architecture is vital to
protecting global health security. Measles investments have established
networks of laboratories around the world capable of processing
diagnostics, and has bolstered the global public health workforce of
trained professionals and volunteers who are often the first responders
during health crises. During the pandemic, for instance, these assets
and infrastructure investments were pivoted to detect and test cases of
COVID-19, giving vulnerable countries a head start in their pandemic
response. With this context in mind, we respectfully provide the
following justification for continued robust investment in CDC's global
measles and rubella elimination efforts.
why measles and rubella?
U.S. leadership has saved the lives of 25.5 million children
between 2000 and 2019, with the Measles & Rubella Initiative driving
measles deaths down by 62%.
Measles is a highly contagious disease that can cause blindness,
swelling of the brain, and death. Nine out of ten people who are not
immune to measles will contract the disease if they come into contact
with a contagious person, and there are long-term damages to the immune
system for those who contract the virus. The rubella virus is a leading
infectious cause of birth defects in the world despite availability of
an affordable, effective vaccine since 1969. Every day, roughly 567
children still die of measles-related complications. When rubella
occurs early in a pregnancy, it can cause miscarriages, stillbirths, or
a constellation of severe birth defects as part of congenital rubella
syndrome (CRS) that can impact vision, hearing, heart health, overall
development. Each year roughly 100,000 babies are born with CRS despite
the preventable nature of the disease.
Since 2000, measles vaccines have been the single greatest
contribution in reducing preventable child deaths globally. We have had
safe and effective vaccines against both rubella and measles for over
50 years, but unfortunately vaccination rates globally have stagnated
for over a decade.
domestic implications
In the U.S., measles control measures have been strengthened, and
endemic transmission of measles cases has been eliminated since 2000
and rubella in 2002. However, importations of measles cases into this
country continue to occur each year. In 2019, for example, the U.S.
reported 1,282 cases of measles in 32 states, the largest number of
cases since 1992. Major outbreaks in New York and Washington state have
been linked to importation of the disease by unvaccinated U.S.
residents returning from trips to Israel and Ukraine. Controlling
measles and rubella around the world reduces the likelihood of similar
disease importations in the future.
Responding to measles outbreaks is resource intensive and costly
for health systems, including in the U.S. In a literature review that
included 10 studies on measles outbreaks from 2001 to 2018 in the U.S.,
researchers estimated the cost per case to range from about $7,000 to
$76,000 and the total cost per outbreak ranged from $10,000 to $1
million. A recent study of a 72-case outbreak in the U.S. cost local
public health and government authorities an estimated $3.4 million for
response activities, medical costs, and productivity losses.
the measles & rubella initiative
The Measles & Rubella Initiative (M&RI)--which includes the
American Red Cross, CDC, UNICEF, the United Nations Foundation, and
WHO, all working in collaboration with Gavi, the Vaccine Alliance as
well as the Bill & Melinda Gates Foundation--supports countries to
prevent, identify, and respond to measles outbreaks through key
interventions like surveillance, supplementary vaccination campaigns,
and emergency response.
M&RI has achieved outstanding results by helping to vaccinate
nearly 3 billion individuals in over 90 countries since 2001, saving
the lives of more than 25.5 million children. In part due to M&RI,
global measles mortality has dropped 62%, from an estimated 545,000
deaths in 2000 to an approximately 207,000 in 2019 (the latest year for
which data is available), mostly children under the age of five. During
this same period, measles deaths in Africa fell by 57%.
Despite these gains, we continue to see unfortunate and preventable
deaths and complications due to both measles and rubella. In 2019,
every day approximately 567 children died of measles-related
complications. These deaths could have been prevented with a safe,
effective, and inexpensive vaccine that is typically available for less
than $2 USD in lower income countries, which protects against both
measles and rubella.
Thanks to M&RI leadership, most measles vaccination campaigns have
been able to reach more than 90% of their target populations. Countries
recognize the opportunity that measles vaccination campaigns provide in
reaching mothers and young children and integrating the campaigns with
other life-saving health interventions. These include administering
vitamin A, which is crucial for preventing blindness in under nourished
children; de-worming medicine to reduce malnutrition; doses of oral
polio vaccines; distributing insecticide treated bed nets to help
prevent malaria and screening for malnutrition. The provision of
multiple child health interventions during a single campaign is far
less expensive than delivering the interventions separately and has a
far greater impact on a child's health.
In addition to the lifesaving benefits of the measles-rubella
vaccine, immunization makes sound economic sense. A 2016 Johns Hopkins
University study compared the costs for vaccinating against 10 disease
antigens in 94 low- and middle-income countries between 2011-2020
versus the costs for estimated treatments of unimmunized individuals
during the same period. Their findings show, on average, every $1
invested in these 10 immunizations produces $44 in savings in
healthcare costs, lost wages, and economic productivity. The return on
investment for measles immunization was found to be the greatest with
$58 saved for every $1 invested.
Securing sufficient funding for measles and rubella-elimination
activities both globally and nationally is critical. The decrease in
donor funds available at a global level to support measles and rubella
elimination activities makes increased political commitment and country
ownership of the activities critical for achieving and sustaining the
goal of increasing measles vaccination coverage to 95%. Implementation
of timely measles and rubella vaccination campaigns is increasingly
dependent upon countries funding these activities locally, which can be
challenging under such downward financial pressure.
If such challenges are not addressed, the remarkable gains made
since 2000 will be lost and a major resurgence in measles death and
disability will occur. The combined factors of a highly contagious
disease, growing immunity gaps exacerbated by COVID-19 disruptions, and
our highly interconnected world means measles is poised to spread
quickly, with devastating results that could even threaten countries
that have already eliminated the disease. The threat of importation of
measles was one of the reasons that the Global Health Security Agenda
has selected measles as an important indicator of whether a country's
routine immunization system is able to effectively reach and vaccinate
all its children.
the role of cdc in global measles mortality reduction
Since FY 2001, Congress has generously provided funding to protect
children and their families from the threat of measles and rubella in
developing countries, thereby also protecting the U.S. population from
the threat of measles importations. Funding for measles and rubella
globally has remained level since FY 2010 at $50 million dollars. The
COVID-19 pandemic has gravely disrupted immunization systems around the
world, leaving millions of children vulnerable to measles and other
vaccine-preventable diseases. We must quickly ``catch up'' vaccination
coverage rates to reach unvaccinated populations and prevent
devastating measles outbreaks. The CDC plays an essential role within
this space by providing support for vaccination programs and
surveillance to detect outbreaks early and stop them at their source.
An increase in resources for these and other critical activities
provided by the CDC are needed to prevent needless childhood deaths
around the globe.
In 2019, thanks in part to U.S. funding, M&RI supported 62
immunization campaigns in 53 countries, resulting in the vaccination of
nearly 203 million children. Funding for CDC permitted the provision of
technical support to Ministries of Health that included: 1) planning,
monitoring, and evaluating large-scale measles vaccination campaigns;
2) conducting epidemiological investigations and laboratory
surveillance of measles outbreaks; 3) CDC's Global Measles Reference
Laboratory serving as the leading worldwide reference laboratory for
measles and rubella; and 4) conducting operations research to guide
cost-effective and high-quality measles and rubella elimination
programs.
Since FY10, the CDC's measles and rubella elimination program has
been funded at approximately $50 million. In FY 2022, the American Red
Cross and United Nations Foundation respectfully request an increase of
$10 million to raise funding to $60 million. This investment will allow
CDC to help countries to close the immunization gap created by COVID-
19, safeguard the progress made over the last decade and protect
Americans by preventing measles cases and deaths in the U.S. The CDC
Global Immunization Division, through which the Measles & Rubella
Initiative is funded, has been highly effective and we strongly support
fully funding this work. All the programs funded through the Global
Immunization Division budget line also help to build stronger health
systems. We respectfully request $60 million for CDC's measles
elimination activities, as part of the overall funding for the entire
Global Immunization Division account in FY2022.
Thank you for the opportunity to submit testimony, and for your
continued commitment to ending preventable death and disability from
measles and rubella.
[This statement was submitted by Koby J. Langley, Senior Vice
President,
International Services and Service to the Armed Forces, American
National Red Cross and Peter Yeo, Senior Vice President, United Nations
Foundation.]
______
Prepared Statement of the American Nurses Association
The American Nurses Association (ANA), representing the interests
of the nation's 4.2 million registered nurses, thanks Chair Murray,
Ranking Member Blunt, and the U.S. Senate Appropriations Subcommittee
on Labor, Health and Human Services, Education and Related Agencies for
the opportunity to provide written testimony for Fiscal Year (FY) 2022.
ANA is committed to advancing the nursing profession by fostering
high standards of nursing practice, promoting a safe and ethical work
environment, bolstering the health and wellness of nurses, and
advocating on health care issues that affect nurses and the public. ANA
is at the forefront of improving quality of health for all.
nursing workforce and health equity
Investments in the Title VIII Nursing Workforce Development
Programs are essential to ensuring nurses and nursing students have the
resources to tackle our nation's health care needs, remain on the
frontlines of the COVID-19 pandemic, and be prepared for the public
health challenges of the future. Funding for Title VIII has become even
more crucial during the pandemic, as these programs connect patients
with high-quality nursing care in community health centers, hospitals,
long-term care facilities, local and state health departments, schools,
workplaces, and patients' homes.
ANA believes there are multiple policy levers to eliminate or
reduce health disparities. Our Principles for Health System
Transformation \1\ call for expanded access to care through universal
coverage and other steps to improve the quality and affordability of
health care. We also believe policymakers must consider and account for
an adequate health care workforce of the future. The nursing workforce,
in particular, can play a tremendous role in efforts to create a more
equitable health care system. Nurses provide the type of care and
coordination that can help people manage their chronic conditions,
including links to community resources they need to be healthy.
Registered nurses and advanced practice registered nurses are often the
backbone of health care delivery in rural and underserved areas,
providing access to primary care, maternity care, and prevention. These
roles should be strengthened through meaningful reforms.
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\1\ https://www.nursingworld.org/4afd6b/globalassets/
practiceandpolicy/health-policy/principles-
healthsystemtransformation.pdf.
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Expanding the minority health care workforce would be one of the
most meaningful steps we could take to improve access and health care
in African American population groups. We know that positive patient
experience and trust in health care providers can be powerful drivers
of health outcomes. The National Sample Survey of Registered Nurses
recently reported an increase in the minority nursing workforce between
2008 and 2018.\2\ This is encouraging, but there is a long way to go.
An increased funding in minority nursing education, to develop a
workforce that is more reflective of the patient population would be a
first step in the right direction.
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\2\ https://bhw.hrsa.gov/data-research/access-data-tools/national-
sample-survey-registered-nurses.
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ANA is a member of the Nursing Community Coalition which is
comprised of 63 national nursing organizations who collectively
represent the cross section of education, research, practice, and
regulation within the nursing profession. Together, we respectfully
request supporting at least $530 million for the Nursing Workforce
Development Programs (authorized under Title VIII of the Public Health
Service Act [42 U.S.C. 296 et seq.] and administered by HRSA) in FY
2022.
public health infrastructure
The nation's public health infrastructure and workforce have been
underfunded for decades, and we have witnessed the highlighted impacts
of this chronic underfunding throughout the COVID-19 public health
emergency. Federal funds for state, local, and tribal public health
preparedness shrunk from $940 million in 2002 to $675 million in
2019.\3\ During the same time period, hospital emergency preparedness
was cut by nearly fifty percent, from $515 million in 2004 to $265
million in 2019. This has resulted in a loss of 55,000 public health
workers since 2008. The current COVID-19 public health emergency has
underscored that our nation must be better equipped with preparedness
and response personnel, measures and processes. A robust public health
infrastructure and workforce is not only important during the time of
crisis, but generally to address the overall health and well-being of
our population.
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\3\ https://www.tfah.org/wp-content/uploads/2020/04/
TFAH2020PublicHealthFunding.pdf.
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The public health nursing workforce touches every aspect of health
care and community well-being. Unfortunately, we can only imagine how
different the coronavirus response would have been had greater federal
public health infrastructure investment afforded availability of
sufficient numbers of nurses and other public health personnel in areas
of the greatest need. Nurses could have played an enhanced role in
encouraging and administering COVID-19 tests in high-risk populations,
conducting contact tracing at an effective pace, educating the public
about vaccine safety and all facets of COVID-19 prevention and
mitigation, informing school opening protocols, and collecting data for
feedback to pandemic response efforts.
mental health
Nurses, particularly those early in their career, continue to feel
exhausted and overwhelmed. According to the findings of an American
Nurses Foundation survey of nearly 13,000 nurses, 51 percent of nurses
surveyed continue to feel exhausted and 43 percent report feeling
overwhelmed. A breakdown of findings demonstrates that the mental
health of early-career nurses, 34 and under, is impacted most, with 81
percent reporting they are exhausted, 71 percent saying they are
overwhelmed, and 65 percent who report being anxious or unable to
relax. Nurses who are 55 and older reported some strain on their mental
health, with 47 percent reporting feeling exhausted and 31 percent
reporting they had a desire to quit.\4\
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\4\ https://www.nursingworld.org/practice-policy/work-environment/
health-safety/disaster-preparedness/coronavirus/what-you-need-to-know/
mental-health-and-wellness-survey-2/.
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ANA is a member of the Mental Health Liaison Group. We count the
American Psychiatric Nurses Association as a premier Organizational
Affiliate and many psychiatric nurses as members. We request that the
Committee approve the appropriations request put forward by the Mental
Health Liaison Group for FY 2022 for mental health and addiction
policies and programs.\5\
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\5\ https://www.mhlg.org/wordpress/wp-content/uploads/2021/04/MHLG-
FY2022-Approps-Request-Final-4.7.21.pdf.
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minority fellowship program
ANA supports funding and expanding the Minority Fellowship Program
(MFP), which is currently administered by the Substance Abuse and
Mental Health Services Administration (SAMHSA).\6\ The program provides
scholarships to minority mental health and addiction professionals in
nursing, but also in the fields of psychiatry, psychology, social work,
marriage and family therapy, counseling and addictions. The program's
mission is to increase the number of culturally competent behavioral
health professionals who provide mental health and substance use
disorders services to underserved populations.
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\6\ https://www.samhsa.gov/minority-fellowship-program/about.
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The MFP was created in 1974 to provide fellowships to minority
mental health professionals, and, since then, more than 4,400
fellowships have been issued to nurses, psychiatrists, psychologists,
social workers, marriage and family therapists, counselors, and
addiction specialists. According to HHS, minorities are less likely to
receive diagnosis and treatment for their mental illness, have less
access to and availability of mental health services, and often receive
a poorer quality of mental health care. The MFP is the only federal
program financing culturally competent mental health and substance use
disorders professionals.
ANA, along with the MFP Coalition, urges Congress to increase
funding for the MFP to $20,200,000 in FY 2022 in order to expand access
to nurses and other mental health professionals who provide culturally
competent mental health and substance abuse services to ethnic minority
populations.
Thank you for the opportunity to provide written testimony as the
Subcommittee continues its important work. If you have any questions,
please contact Ingrida Lusis, Vice President of Policy and Government
Affairs, at [email protected].
[This statement was submitted by Debbie D. Hatmaker, PhD, RN, FAAN,
Chief Nursing Officer/EVP.]
______
Prepared Statement of the American Psychological
Association Services, Inc.
The American Psychological Association (APA) is the largest
scientific and professional organization representing psychology in the
United States, with more than 122,000 researchers, educators,
clinicians, consultants, and students as its members. Our mission is to
promote the advancement, communication, and application of
psychological science and knowledge to benefit society and improve
lives.
Many programs in the Labor-HHS-Education Appropriations bill are
critical to strengthening the mental health workforce, supporting
psychology-based research and education, and improving access to needed
mental and behavioral health services, particularly for underserved
communities. As the COVID-19 pandemic continues to present broad
challenges for our nation in both the short and long term, federal
investments are needed to bolster research, expand equitable access to
primary and mental health services, and support data-informed
approaches to education and public welfare at all levels. To boost
critical research funding, support the psychology workforce, improve
access to mental and behavioral health services across the lifespan,
and address social determinants of health, APA requests the following
funding levels for FY22 within the U.S. Department of Health and Human
Services, U.S. Department of Education, and U.S. Department of Labor.
Boosting Critical Research Funding: APA requests at least $46.111
billion for NIH in FY22, including $48.9 million for the NIH Office of
Behavioral and Social Sciences Research (OBSSR). This funding would
allow OBSSR to continue leading the coordination and support of
research designed to address the social, behavioral, and economic
effects of COVID-19 and its associated containment and mitigation
efforts. Understanding these impacts will help policymakers improve
their long-term response to the pandemic and prepare more effectively
and efficiently for the country's next public health emergency. APA
encourages the Committee to resist calls to limit the availability or
use of non-human animal models in research, and to ensure this research
continues to be conducted appropriately and ethically.
APA recommends at least $700 million for the Institute of Education
Sciences (IES), which supports and disseminates scientific evidence on
which to base education policy and practice and funds innovative
research into many aspects of teaching and learning, including research
on pandemic-related learning loss. Finally, APA urges the Committee to
provide $50 million in funding shared evenly between the CDC and NIH to
conduct public health research into firearm morbidity and mortality
prevention. This research is fundamental to helping our nation better
understand and address our gun violence public health crisis.
Supporting the Psychology Workforce: The nation's mental and
behavioral health workforce must be expanded to adequately respond to
the long-term mental health and substance use disorder ramifications of
the COVID-19 pandemic, particularly the needs of long-underserved
communities like communities of color and older adults. This includes
foundational investments in higher education, as well as workforce
training programs that support the integration of behavioral
healthcare. To address this, APA supports increased funding for the
following programs within the Department of Education and HHS' Health
Resources and Services Administration (HRSA), Substance Abuse and
Mental Health Services Administration (SAMHSA).
Given the heavy burden of student loan debt, APA supports added
investments in grant programs for graduate study within the Department
of Education, including $35 million for the Graduate Assistance in
Areas of National Need (GAANN) Program. The most recent funding cycle
marked the first time in nearly a decade where psychology was among the
designated areas of national need under this program. As the mental
health impact of the pandemic continues to unfold, APA requests that
the committee again direct the Secretary to include academic areas that
fall under the Classification of Instructional Programs (CIP) 51.15
Mental Health Services in the next grant competition.
Within HRSA, APA joins the Mental Health Liaison Group (MHLG) in
urging the Committee to provide $23 million for the Graduate Psychology
Education Program; $90 million for the Behavioral Health Workforce
Education and Training (BHWET) Grant Program; and $37 million for the
Mental and Substance Use Disorder Workforce Training Demonstration.
These essential programs increase work to increase our nation's supply
of health service psychologists trained to provide integrated services
to high-need, underserved populations in rural and urban communities.
To expand access to non-pharmacological pain management to improve pain
care and reduce the incidence of opioid use disorders, APA recommends
$10 million for a program for education and training in pain care, as
authorized by the SUPPORT Act under Section 759 of the Public Health
Service Act (42 U.S.C. 294i).
Within SAMHSA, APA requests $20.2 million for the Minority
Fellowship Program (MFP). This increase will support the program's dual
mission to both increase the diversity of the mental and behavioral
health workforce while improving access to mental health and substance
use disorder services in underserved communities.
Improving Access to Mental and Behavioral Health Care Across the
Lifespan: Given the rise in COVID-related mental health concerns, APA
joins MHLG in requesting $833 million for SAMHSA's Community Mental
Health Block Grant (MHBG) and $1.9 billion for the Substance Abuse
Prevention and Treatment (SAPT) Block Grant in FY22. To address rising
suicide rates, we urge the Committee to provide $240 million for the
National Suicide Prevention Lifeline; $5 million for 988
implementation, $37 million for the State/Tribal Youth Suicide
Prevention Program; $6.7 million for the Campus Mental and Behavioral
Health Program; and $9.3 million for the Suicide Prevention Resource
Center.
To ensure that our K-12 students receive a well-rounded education,
and access to school-based mental health services and programs that
foster safe and healthy schools, APA requests $2 billion for Title IV-
A, the Student Support and Academic Enrichment (SSAE) block grant.
Additionally, to increase the number of mental health providers working
in school settings, APA requests $606 million for the Safe Schools
National Activities Program in order to support new competitions for
the School Based Mental Health Services Professional Demonstration
Grant and the School-Based Mental Health Services Grant Program. APA
also urges the Committee to include $15.5 billion for Part B (Grants to
States) of the Individuals with Disabilities Education Act (IDEA) to
help provide an equitable education for students with disabilities.
Given that maternal mental health conditions are the most common
complication of pregnancy and childbirth, APA joins the Maternal Mental
Health Leadership Alliance and more than 100 other organizations in
requesting $5 million for HRSA's Maternal Mental Health Hotline, and
$10 million for the Screening and Treatment of Maternal Depression and
Related Behavioral Disorders Program. APA urges to Committee to provide
$750 million for Title V Maternal and Child Health Services Block Grant
Program, which supported 92% of all pregnant women in the U.S. in FY19.
Finally, APA urges the Committee to provide much-needed funding to
support Mental Health Parity and Addiction Equity Act (MHPAEA)
enforcement. Within the DOL's Employee Benefits Security
Administration, APA requests $25 million for MHPAEA enforcement, with
10% allocated to Office of Solicitor for parity litigation. To support
MHPAEA enforcement within HHS, APA requests $10 million for CMS' Center
for Medicaid and CHIP Services (CMCS).
Addressing Social Determinants of Health & Social Safety Net:
Within HHS' Administration for Children and Families, APA supports $1.7
billion for the Social Services Block Grant, which provides vital
social services, such as protective services agencies and special
services to people with disabilities. In addition, APA urges the
Committee to provide $10.7 billion for the Head Start Program, $5.9
billion for Preschool Development Grants, and $500 million for CAPTA
Title I to support state child abuse prevention and treatment.
To expand the reach out various federal HIV programs, APA requests
$100 million for the CDC Division of Adolescent and School Health
(DASH), to increase access to health services, implement evidence-based
sexual health education, and foster supportive environments for young
people to learn. APA also supports $160 million for the SAMHSA Minority
AIDS Initiative to expand efforts at preventing domestic HIV
transmission and to increase treatment options for those living with
co-morbid conditions. APA urges the Committee to provide $120 million
for the infectious diseases and opioid program at CDC. Currently funded
at a level well below its actual need, this program increases
prevention, testing, and linkages to provide a strong ground-level
response to the intersecting crises of opioid addiction, HIV, and
hepatitis. Finally, to strengthen public health surveillance
activities, APA requests $250 million for the CDC's Data Modernization
Initiative (DMI).
[This statement was submitted by Katherine B. McGuire, Chief
Advocacy Officer, American Psychological Association Services, Inc.]
______
Prepared Statement of the American Public Health Association
APHA is a diverse community of public health professionals that
champions the health of all people and communities. We are pleased to
submit our request of at least $10 billion for the Centers for Disease
Control and Prevention and at least $9.2 billion for the Health
Resources and Services Administration in FY 2022. Robust funding for
CDC and HRSA programs that promote public health and prevention,
support surveillance of infectious disease and bolster America's public
health workforce will be critical in addressing both the short-term and
long-term health impacts of COVID-19 and the many other health
challenges we face as a nation. We are thankful for the emergency
supplemental funding provided to CDC and HRSA to support the nation's
response to COVID-19 and we urge the committee to ensure that all CDC
and HRSA programs are adequately funded in FY 2022.
Centers for Disease Control and Prevention: CDC provides the
foundation for our state and local public health departments,
supporting a trained workforce, laboratory capacity and public health
education communications systems. It is notable that more than 70% of
CDC's budget supports public health and prevention activities by state
and local health organizations and agencies, national public health
partners and academic institutions. We urge a funding level of at least
$10 billion in FY 2022. We are grateful for the important increases
provided for CDC programs in FY 2021 and for the critical emergency
funding provided to the agency to address COVID-19. We urge Congress to
build upon these investments to strengthen all of CDC's programs, many
of which remain woefully underfunded. We also urge your continued
support for the Prevention and Public Health Fund which currently makes
up approximately 11% of CDC's budget.
CDC serves as the command center for the nation's public health
defense system against emerging and reemerging infectious diseases.
From aiding in the surveillance, detection and prevention of the
current COVID-19 outbreak globally and in the U.S. to playing a lead
role in the control of Ebola in West Africa and the Democratic Republic
of the Congo, to monitoring and investigating disease outbreaks in the
U.S., to pandemic flu preparedness to combating antimicrobial
resistance, CDC is the nation's--and the world's--expert resource and
response center, coordinating communications and action and serving as
the laboratory reference center for identifying, testing and
characterizing potential agents of biological, chemical and
radiological terrorism, emerging infectious diseases and other public
health emergencies.
We strongly support the president's budget request for $400 million
in new funding to bolster core public health infrastructure and
capacity at the federal, state, territorial and local levels. This
flexible funding is critical to addressing the gaps in core public
health infrastructure and capacity at all levels as well as ensuring
our nation's health departments are able to attract and retain
experienced leaders and respond to future public health emergencies and
disease outbreaks. Sustained, flexible funding is critical to
rebuilding and strengthening the nation's public health system.
CDC serves as the lead agency for bioterrorism and other public
health emergency preparedness and response programs. We urge you to
provide adequate funding for the Public Health Emergency Preparedness
grants which provide resources to our state and local health
departments to help them protect communities during public health
emergencies. We also urge you to provide adequate funding for CDC's
infectious disease, laboratory and disease detection capabilities to
ensure we are prepared to tackle both ongoing COVID-19 pandemic and
other public health challenges and emergencies that will likely arise
during the coming fiscal year. Your continued support for CDC's public
health Data Modernization Initiative is critical to ensuring we have
both the world-class data workforce and data systems that are ready for
the next public health emergency.
We thank Congress for providing CDC with dedicated funding for
firearm morbidity and mortality prevention research in FY 2020 and FY
2021 and we strongly urge you to increase this funding in FY 2022 to
$50 million for CDC and NIH, as requested in President Biden's FY 2022
discretionary budget proposal. This will allow CDC to conduct research
into important issues including the best ways to prevent unintended
firearm injuries and fatalities among women and children; the most
effective methods to prevent firearm-related suicides; and the measures
that can best prevent the next shooting at a school or public place.
CDC's National Center for Environmental Health works to control
asthma, protect against threats associated with natural disasters and
climate change, reduce and monitor exposure to lead and other
environmental health hazards and ensure access to safe and clean water.
We urge you to provide at least $322 million for NCEH in FY 2022,
including $110 million for CDC's Climate and Health program, as
requested in President Biden's FY 2022 discretionary budget request.
Climate change is threating our health in many ways through the
increased spread of vector-borne diseases, degraded air quality from
ozone pollution and wildfire smoke, hotter temperatures and more
extreme weather events. Increased funding will allow CDC to provide
funding to all 50 states and to support additional, cities, counties
and tribes to help them prepare for and respond to the health impacts
of climate change in their communities.
Programs under the National Center for Chronic Disease Prevention
and Health Promotion address heart disease, stroke, cancer, diabetes
and tobacco use that are the leading causes of death and disability in
the U.S. and are also among the costliest to our health system. CDC
provides funding for state programs to prevent disease, conduct
surveillance to collect data on disease prevalence, monitor
intervention efforts and translate scientific findings into public
health practice in our communities. We strongly urge increased
investments in these critical programs that are essential to reducing
death, disability and health care costs. In particular, we urge your
support for the president's request of $153 million for CDC's Social
Determinants of Health Program. This increased funding would allow CDC
to provide public health departments, academic institutions and
nonprofit organizations funding and tools to support cross sector
efforts to address the impact that social determinants of health such
as unsafe and unstable housing, income insecurity, lack of
transportation, and underlying health inequities have on the health of
their communities.
Health Resources and Services Administration: HRSA is the primary
federal agency dedicated to improving health outcomes and achieving
health equity. HRSA's 90-plus programs and more than 3,000 grantees
support tens of millions of geographically isolated, economically or
medically vulnerable people, in every U.S. state and territory, to
achieve improved health outcomes by increasing access to quality health
care and services; fostering a health care workforce able to address
current and emerging needs; enhance population health and address
health disparities through community partnerships; and promote
transparency and accountability within the health care system.
We are grateful for the increases provided for HRSA programs in FY
2021 and for the emergency supplemental funding to battle the COVID-19
pandemic, but HRSA's discretionary budget authority is far too low to
effectively address the nation's current public health and health care
needs. We recommend Congress build upon the important increases they
provided HRSA in FY21 and provide at least $9.2 billion for the Health
Resources and Services Administration in FY 2022
HRSA programs and grantees are providing innovative and successful
solutions to some of the nation's greatest health care challenges
including the rise in maternal mortality, the severe shortage of health
professionals, the high cost of health care and behavioral health
issues related to substance use disorders-including opioid misuse.
Additional funding will allow HRSA build upon these successes and pave
the way for new achievements by supporting critical HRSA programs,
including:
Primary Health Care that supports nearly 13,000 health center sites
in medically underserved communities across the U.S., providing access
to high-quality preventive and primary care to nearly 30 million people
including 1 in 3 people living in poverty.
Health Workforce supports the health workforce across the training
continuum and offers scholarship and loan repayment programs to ensure
a well-prepared, well-distributed and diverse workforce that is ready
to meet the current and evolving health care needs of the nation.
Maternal and Child Health supports initiatives that reduce infant
mortality, minimize disparities, prevent chronic conditions and improve
access to quality health care for vulnerable women, infants and
children; and serves 60 million people through the MCH block grant.
HIV/AIDS programs deliver a comprehensive system of care to more
than 519,000 individuals impacted by HIV/AIDS, improving health
outcomes for people with HIV and reducing the chance of others becoming
infected, and provides training for HIV/AIDS health professionals.
HRSA's Ryan White HIV/AIDS Program effectively engages clients in
comprehensive care and treatment, including increasing access to HIV
medication, which has resulted in 88.1% of clients achieving viral
suppression, compared to just 64.7% of all people living with HIV
nationwide.
Family Planning Title X services ensure access to comprehensive
family planning and preventive health services for over 3.1 million
people, reducing unintended pregnancy rates, limiting sexually
transmitted infection transmission and increasing early detection of
cancers.
Rural Health supports community solutions to improve efficiencies
in delivering rural health services and expand access, including
supporting activities that aim to increase access to opioid treatment
in rural areas and promote the use of health information technology and
telehealth.
HRSA has also been active in the COVID-19 pandemic response,
awarding billions of dollars to health centers to administer COVID-19
tests and reimbursing providers who offer COVID-19 care to uninsured
individuals.
In closing, we emphasize that the public health system requires
stronger financial investments at every stage. It is critical that
Congress increase its investments in CDC and HRSA programs to enable
the nation to meet the mounting health challenges we currently face and
to become a healthier nation.
[This statement was submitted by Georges C. Benjamin, MD, Executive
Director, American Public Health Association.]
______
Prepared Statement of the American Society for Engineering Education
This written testimony is submitted on behalf of the American
Society for Engineering Education (ASEE) to the Senate Subcommittee on
Labor, Health and Human Services, Education, and Related Agencies for
the official record. ASEE appreciates the Committee's support for the
Department of Education (ED) in fiscal year (FY) 2021 and asks you to
robustly fund student aid, teacher preparation, and STEM programs in FY
2022. Additionally, ASEE requests federal funding to support
initiatives aimed at increasing the diversity of the STEM pipeline and
support for Minority-Serving Institutions (MSIs). The strong support of
the National Institutes of Health (NIH) in FY 2021 was greatly
appreciated and ASEE requests continued support of NIH.
The American Society for Engineering Education (ASEE) advances
innovation, excellence, and access at all levels of education for the
engineering profession and is the only society representing the
country's schools and colleges of engineering and engineering
technology. Membership includes over 12,000 individuals hailing from
all disciplines of engineering and engineering technology including
educators, researchers, and students as well as industry and government
representatives. As the pre-eminent authority on the education of
engineering professionals, ASEE seeks to advance the development of
innovative approaches and solutions to engineering education and
advocates for equal access to engineering educational opportunities for
all.
Student Aid
Student aid programs like Pell Grants, Federal Work-Study (FWS),
TRIO, and others make higher education accessible and affordable for
millions of students. We appreciate the commitment the Biden
Administration has made to affordable education through its preliminary
Presidential Budget Request and the American Families Plan. ASEE joins
the higher education community in requesting funding to support
doubling the maximum Pell Grant award to $12,990. Pell Grants are
essential to low-income students being able to afford higher education.
These awards are vital in helping students access the significant life
and career benefits that higher education provides. These benefits are
especially prevalent for engineering education, which provides a proven
pathway to the middle class, especially for students from low-income
backgrounds. ASEE requests funding for Federal Work Study (FWS) at
$1.480 billion and $1.061 billion for Supplemental Educational
Opportunity Grant (SEOG). These programs are need-based, and often this
aid provides the resources a student needs to complete their education.
ASEE asks the Committee to consider ways to support work-based
learning, such as co-operative education and apprenticeships, within
the FWS program. ASEE firmly believes in ensuring access to engineering
and engineering technology education for all students, not just those
who can afford it, which is why ensuring student aid programs for
graduate students is also very important. ASEE requests funding for the
Graduate Assistance in Areas of National Need (GAANN) program, which
provides fellowships, through academic departments and programs of
institutions of higher education, to assist graduate students with
excellent records who demonstrate financial need. ASEE requests $35
million for GAANN.
Teacher Preparation
The need for well-prepared and content-confident teachers in early
childhood, elementary, and secondary education is high, particularly in
STEM subjects. The lack of teacher training focused on STEM, and
engineering in particular, is an important issue facing K-12 education.
Problem-based learning that incorporates engineering design and
analysis skills are often absent from teacher preparation and
professional development programs. ASEE supports vigorous funding for
Title II of the Elementary and Secondary Education Act (ESEA), which
supports the preparation and professional development of school
personnel, and Title II of the Higher Education Act, which supports
teacher preparation programs at institutions of higher education. ASEE
also supports President Biden's proposal to invest $9 billion in
training and diversifying the teaching workforce presented in the
American Families Plan. Efforts to support teaching skills for STEM
postsecondary faculty should also be considered and could include
partnerships between STEM disciplines and Schools of Education to
support STEM faculty and support for teaching and learning centers at
postsecondary institutions. Support of postsecondary faculty and their
promotion of STEM learning should utilize research-based methods. Our
future is dependent on today's students finding solutions to tomorrow's
problems. This can only be accomplished if those students have teachers
who are prepared to guide them in developing the knowledge and skills
needed to solve those problems.
STEM
Support for science, technology, engineering, and mathematics
(STEM) continues to grow and ASEE appreciates the support many STEM
programs received in FY 2021. ASEE supports funding for Title IV of the
Elementary and Secondary Education Act (ESEA) at its authorized amount
of $1.6 billion, which will allow states and school districts
additional resources to pursue STEM programs. ASEE supports robust
funding for STEM programs for higher education students including the
Hispanic-Serving Institutions (HSI) STEM and Minority Science and
Engineering Improvement (MSEIP) programs. The STEM workforce is a
driving force behind innovation and our economic development. These and
other programs targeted towards increasing the representation of
historically underrepresented populations, including women, will ensure
a healthy STEM workforce pipeline.
Career and Technical Education (CTE)
ASEE knows that high-quality Career and Technical Education (CTE)
prepares students for careers and further postsecondary education while
fulfilling employer needs in high-demand sectors of the economy.\1\
ASEE supports CTE and wants to ensure best practices and high-quality
programs are embedded in its programs, for example through faculty
professional development and connections to the National Science
Foundation -supported Advanced Technological Education (ATE) programs.
ASEE also wants to strengthen pathways between CTE at the associate
degree level to 4-year engineering technology and engineering degrees.
ASEE believes that students should have lifelong options for continuing
study and career advancement and that CTE programs can help students
achieve their goals. In order for states and their CTE educators to
provide high-quality CTE opportunities for students and strengthen
pathways between two- and four-year institutions of higher education,
ASEE urges Congress to robustly fund the Perkins Basic State Grant
funding program in FY 2022 and encourage the program to build
connections with NSF's ATE program.
---------------------------------------------------------------------------
\1\ https://www.acteonline.org/wp-content/uploads/2021/04/
2021_ACTE_Legislative_Priorities
_April.pdf.
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National Institutes of Health--National Institute of Biomedical Imaging
and Bioengineering (NIBIB)
NIBIB is the major NIH Institute focused on engineering
applications to human health and training the next generation of
biomedical engineers. ASEE is grateful to the committee for its strong
bipartisan support of the NIH in FY 2021. NIBIB funding is critical for
the development of devices and tools that can improve the detection,
treatment, and prevention of disease, and also plays a critical role in
assessing the effectiveness of new drugs and treatment procedures.
NIBIB also supports training programs to enhance and expand education
and training for the next generation biomedical engineering workforce.
Through grant programs like the Enhancing Science, Technology, and Math
Education Diversity Research Education Experiences, and Team-Based
Design in Biomedical Engineering Education, NIBIB is committed to
supporting all stages of the biomedical engineering career pathway and
increasing the participation of traditionally underrepresented groups
in engineering. ASEE urges the Committee to provide NIH with $46.1
billion in FY 2022 so that NIBIB can continue to support critical
biomedical engineering research and training.
conclusion
Engineering and engineering technology academic programs play
critical roles in the STEM ecosystem. The requests made here support
the development of a skilled technical workforce, broadening
participation, and transdisciplinary study. Thank you for the
opportunity to submit this testimony.
[This statement was submitted by Sheryl Sorby, Ph.D., President,
and Norman Fortenberry, Sc.D., Executive Director, American Society for
Engineering
Education.]
______
Prepared Statement of the American Society for Microbiology
The American Society for Microbiology (ASM) is the one of the
largest life science societies, composed of more than 30,000 scientists
and health professionals. Our mission is to promote and advance the
microbial sciences. ASM respectfully requests that Congress provide at
least $46.1 billion for the National Institutes of Health (NIH) and at
least $10 billion for the Centers for Disease Control and Prevention
(CDC) in fiscal year (FY) 2022. Within the CDC budget, we request $60
million for the Advanced Molecular Detection (AMD) program in the
National Center for Emerging and Zoonotic Infectious Diseases.
Achieving Remarkable Outcomes Through a Strong Investment in the NIH
We thank Congress for its longstanding, bipartisan support for the
NIH and for its commitment to basic, translational, and clinical
microbial research funded through multiple Institutes and Centers,
particularly through the National Institute of Allergy and Infectious
Diseases (NIAID). We especially thank Chairman Leahy, Vice Chairman
Shelby, Chair Murray and Ranking Member Blunt and members of the Senate
Appropriations Subcommittee on Labor, Health and Human Services,
Education and Related Agencies for their unwavering support for the NIH
and leadership over the past six years, during which they and their
Senate counterparts have worked in a bipartisan manner to place the NIH
budget back on the path of meaningful growth above inflation.
Thanks to a renewed commitment to NIH, researchers were able to
pivot when SARS-CoV-2 emerged and the race to develop tests, vaccines
and therapeutics commenced. Researchers built on decades of federally-
funded basic science and technological advances to develop safe and
effective vaccines at record speed. This remarkable achievement has
reenergized existing and aspiring scientists worldwide, allowed our
country to begin moving past the pandemic, and demonstrated the power
of public-private partnerships. Continuing to provide robust, sustained
and predictable funding for the NIH is the only way we will seize the
unparalleled scientific opportunities in microbial research that lie
before us, and the only way we will be equipped to address the demands
that future infectious disease outbreaks will place on our society.
NIH Funding has Transformed the Microbial Sciences
Even before the COVID-19 pandemic, investments in microbial
research at NIH led to great strides in protecting and improving human
health as illustrated by the following advances:
--A young person diagnosed with Human Immunodeficiency Virus (HIV)
today who receives treatment will have a near normal life
expectancy. The AIDS death rate has dropped 80% from its peak
in 1995.
--Routine childhood vaccinations prevent millions of cases of
illness. For children vaccinated in 2009, an estimated $82
billion in costs will be saved and 20 million cases, including
42,000 early deaths, will be prevented.
--The first preventive vaccine and experimental treatments were
recently deployed in Africa against the Ebola virus, marking a
significant public health achievement. The Ebola virus, which
ravaged West Africa in 2013 and continues to cost lives in the
Democratic Republic of the Congo, has killed more than 10,000
people and severely strained regional socioeconomic stability.
--Since 2007, the NIH has been on the forefront of supporting
microbiome research with the Common Fund's Human Microbiome
Project (HMP), which was formed to develop research resources
to study of microbial communities and how they impact human
health and disease. Microbiome research has increased over 40
times since the inception of the HMP, and the work engages over
20 NIH Institutes and Centers. This important research has had
implications for our understanding of microbiome interactions
in pregnancy and preterm birth, inflammatory bowel disease, and
diabetes, among other topics.
Continued Progress Requires Sustained Funding and Support for
Investigators
Even in the face of the promise and progress highlighted above,
well known pathogens and pathogen resistance threaten our nation's
health with serious economic and social ramifications. Seasonal flu
continues to cost the U.S. billions annually in direct medical costs
and lost productivity due to illness, and claims the lives of thousands
of Americans each year. Through sustained funding to NIAID, scientists
continue the quest for a universal flu vaccine. Antimicrobial
resistance (AMR) is a daunting public health challenge and considered a
global crisis by the World Health Organization, the G20 and the United
Nations. Continued investment in research to better understand how
microbes become resistant, and develop more precise clinical
diagnostics, novel therapeutics and vaccines is greatly needed.
The COVID-19 pandemic has exacted a toll on the broader research
enterprise, especially early career investigators and those who were
unable to pivot to work on SARS-CoV-2. Pandemic-related laboratory
closures disrupted ongoing research, resulted in loss of animal
colonies and cell lines, and loss of laboratory positions. Experiments
will need to be restarted, animal colonies repopulated and fieldwork
rescheduled for an indeterminate later time. While our nation's
research capacity has demonstrated it can absorb shocks, the scale of
this one is still growing and unprecedented in duration and impact.
Congress should consider additional ``research relief'' funding to NIH
to assist in the recovery of our research workforce and projects
negatively affected by the pandemic.
CDC's Indispensable Role in Preventing and Controlling Infectious
Disease
The programs and activities supported by CDC are essential to
protect the health of the American people. ASM appreciates the
extraordinary emergency funding provided to the agency in FY 2021 to
meet the needs presented by the pandemic. However, had Congress
provided necessary support for CDC and public health infrastructure
over time, our country would have been in a better position to address
the public health crisis more effectively from the start. With this in
mind, we urge Congress to build on emergency investments in FY 2022,
including robust funding for the Data Modernization Initiative and the
Prevention and Public Health Fund. CDC aids in surveillance, detection
and prevention of global and domestic outbreaks from novel Coronavirus,
to Ebola, to the measles, to seasonal flu. CDC is the nation's expert
resource and response center, coordinating communications and action,
and serving as the laboratory reference center. As we have seen over
the course of the pandemic, states, communities, and international
partners rely on CDC for accurate information, direction, and resources
to ensure they continue to be prepared in a crisis or outbreak.
Three areas that ASM would like to highlight under CDC are: (1)
advanced molecular detection technology; (2) antimicrobial resistance;
and, (3) laboratory capacity.
--The Advanced Molecular Detection (AMD) program brings cutting edge
genomic sequencing technology to the front lines of public
health by harnessing the power of next-generation sequencing
and high performance computing with bioinformatics and
epidemiology expertise to study pathogens. The program has
played an indispensable role by leading genomic surveillance
efforts and sequencing of SARS-CoV-2 samples, especially aimed
at getting in front of emerging variants. We thank Congress for
providing transformational funding for AMD in the American
Rescue Plan Act, and with increased base funding, the AMD
program can continue to promote innovation, expand workforce
development, and enter into productive partnerships with
academic research institutions and state/local public health
agencies. ASM requests $60 million for AMD in FY 2022.
--Multiple programs support antimicrobial resistance, one of the most
daunting health challenges we face today. ASM requests funding
for the Antibiotic Resistance Solutions Initiative at $672
million, the National Healthcare Safety Network at $100
million, and the Division of Global Health Protection at $465.4
million, which will ensure that we have the resources across
multiple programs to address this urgent public health
challenge.
--Support for laboratory capacity is paramount, and the Emerging and
Zoonotic Infectious Disease labs are the world's reference
labs. But maintaining labs costs more each year, from quality
and safety initiatives, to the cost of shipments and supplies,
to recruiting and retaining specialized and highly trained
staff. We urge you to consider additional funding for resources
to this area, particularly as we consider ways to bolster lab
capacity in times of public health emergency.
ASM looks forward to working with you to ensure that researchers
and public health professionals have the resources they need to apply
fundamental microbial science research to meet 21st Century challenges
in public health promotion, the prevention, detection and treatment of
infectious diseases, and the prevention of outbreaks.
[This statement was submitted by Allen Segal, Public Policy and
Advocacy
Director, American Society for Microbiology.]
______
Prepared Statement of the American Society for Nutrition
Dear Chairman Murray and Ranking Member Blunt:
Thank you for the opportunity to provide testimony regarding Fiscal
Year (FY) 2022 appropriations. The American Society for Nutrition (ASN)
respectfully requests at least $46.1 billion dollars for the National
Institutes of Health (NIH) and $200 million dollars for the Centers for
Disease Control and Prevention/National Center for Health Statistics
(CDC/NCHS) in Fiscal Year 2022. ASN is dedicated to bringing together
the world's top researchers to advance our knowledge and application of
nutrition, and has more than 8,000 members working throughout academia,
clinical practice, government, and industry.
National Institutes of Health (NIH)
The NIH is the nation's premier sponsor of biomedical research and
is the agency responsible for conducting and supporting the largest
percentage of federally funded basic and clinical nutrition research
with $3.2 billion estimated for nutrition and obesity research in 2020.
Although nutrition and obesity research make up just five percent of
the NIH budget, some of the most promising nutrition-related research
discoveries have been made possible by NIH support. NIH nutrition-
related discoveries have impacted the way clinicians prevent and treat
heart disease, cancer, diabetes and other chronic diseases. For
example, from 1990 to 2019, U.S. diet-related death rates decreased
from 154 to 101 deaths per 100,000 population, although the proportion
of deaths attributable to dietary risks was largely stable.\1\ However,
the burden and risk factors remain high. With additional support for
NIH, additional breakthroughs and discoveries to improve the health of
all Americans will be made possible.
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\1\ https://www.ahajournals.org/doi/10.1161/CIR.0000000000000950.
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Investment in biomedical research generates new knowledge, improved
health, and leads to innovation and long-term economic growth. ASN
recommends at least $46.1 billion dollars for NIH in Fiscal Year 2022
to support NIH nutrition-related research that will lead to important
disease prevention and cures. A budget of $46.1 billion will allow NIH
to provide support to the new NIH Common Fund's Nutrition for Precision
Health, powered by the All of Us Research Program, while still
providing much needed increases to other parts of the portfolio. NIH
needs sustainable and predictable budget growth to fulfill the full
potential of biomedical research, including nutrition research, that is
aimed at improving the health and wellbeing of all Americans, as well
as global populations.
Centers for Disease Control and Prevention National Center for Health
Statistics (CDC NCHS)
The National Center for Health Statistics, housed within the
Centers for Disease Control and Prevention, is the nation's principal
health statistics agency. ASN recommends a Fiscal Year 2022 funding
level of $200 million dollars for NCHS to help ensure uninterrupted
collection of vital health and nutrition statistics and help cover the
costs needed for technology and information security maintenance and
upgrades that are necessary to replace aging survey infrastructure. The
U.S. is a leader in this area and a decade of flat funding has taken a
significant toll on NCHS's ability to keep pace.
The NCHS provides critical data on all aspects of our health care
system, and it is responsible for monitoring the nation's health and
nutrition status through surveys such as the National Health and
Nutrition Examination Survey (NHANES), that serve as a gold standard
for data collection around the world. Nutrition and health data,
largely collected through NHANES, are essential for tracking the
nutrition, health and well-being of the American population, and are
especially important for observing nutritional and health trends in our
nation's children. This is an invaluable source of data that has been
and can continue to be used to address major health issues as they
arise.
Nutrition monitoring conducted by the Department of Health and
Human Services in partnership with the U.S. Department of Agriculture/
Agricultural Research Service is a unique and critically important
surveillance function in which dietary intake, nutritional status, and
health status are evaluated in a rigorous and standardized manner.
Nutrition monitoring is an inherently governmental function and
findings are essential for multiple government agencies, as well as the
public and private sector. Nutrition monitoring is essential to track
what Americans are eating, inform nutrition and dietary guidance
policy, evaluate the effectiveness and efficiency of nutrition
assistance programs, and study nutrition-related disease outcomes.
Funds are needed to ensure the continuation of this critical
surveillance of the nation's nutritional status and the many benefits
it provides.
Through learning both what Americans eat and how their diets
directly affect their health, the NCHS is able to monitor the
prevalence of obesity and other chronic diseases in the U.S. and track
the performance of preventive interventions, as well as assess
'nutrients of concern' such as calcium, iron, folate, iodine, vitamin
D, and other micronutrients which are consumed in inadequate amounts by
many subsets of our population. Data such as these are critical to
guide policy development in health and nutrition, including food
safety, food labeling, food assistance, military rations and dietary
guidance. For example, NHANES data are used to determine funding levels
for programs such as the Supplemental Nutrition Assistance Program
(SNAP) and the Women, Infants, and Children (WIC) clinics, which
provide nourishment to low-income women and children. Additional
support would enable collection of more data on under-represented
groups, such as pregnant and lactating women, and assessment of
nutritional status indicators for nutrients on which we have no, or
inadequate, information.
Thank you for the opportunity to submit testimony regarding FY 2022
appropriations for the National Institutes of Health and the CDC/
National Center for Health Statistics. Please contact John E. Courtney,
Ph.D., ASN Executive Officer, at 9211 Corporate Boulevard, Suite 300,
Rockville, Maryland 20850, [email protected], if ASN may provide
further assistance.
Sincerely.
[This statement was submitted by Lindsay H. Allen, Ph.D., 2020-2021
President, American Society for Nutrition.]
______
Prepared Statement of the American Society of Hematology
The American Society of Hematology (ASH) represents more than
17,000 clinicians and scientists committed to the study and treatment
of blood and blood-related diseases, including malignant disorders such
as leukemia, lymphoma, and myeloma; conditions including thrombosis and
bleeding disorders; and congenital diseases such as sickle cell
disease, thalassemia, and hemophilia.
FY 2022 Request: National Institutes of Health (NIH)
American biomedical research has led to new medical treatments,
saved innumerable lives, reduced human suffering, and spawned entire
new industries, none of which would have been possible without support
from the NIH. Hematology research, funded by many institutes at the
NIH, including the National Heart, Lung and Blood Institute (NHLBI),
the National Cancer Institute (NCI), the National Institute of
Diabetes, Digestive and Kidney Diseases (NIDDK), the National Institute
on Aging (NIA), and the National Institute of Allergy and Infectious
Diseases (NIAID), has been an important component of this investment in
the nation's health.
NIH-funded research has led to tremendous advances in treatments
for children and adults with blood cancers and other hematologic
diseases and disorders. Hematology advances also help patients with
other types of cancers, heart disease, and stroke. Basic research on
blood has aided physicians who treat patients with heart disease,
strokes, end-stage renal disease, cancer, and AIDS. The Society
recently updated the ASH Agenda for Hematology Research, which serves
as a roadmap to prioritize research within the hematology field and
includes recommendations for areas of additional federal investment
that will equip researchers to make truly practice-changing discoveries
in hematology and other fields of medicine for years to come.
Additionally, the extraordinary research that has occurred to
identify and develop potential COVID-19 vaccines, antivirals, and other
medical countermeasures is all built on the scientific foundation
enabled by the federal investment in NIH. In response to the emergence
of hematologic complications from COVID-19 infection, ASH developed the
COVID-19 Research Agenda in Hematology, which highlights fundamental
questions that experts in hematology and blood research deem of
critical importance to researchers, physicians, and patients.
ASH thanks Congress for the robust bipartisan support that has
resulted in several consecutive years of welcome and much needed
funding increases for NIH. For FY 2022, ASH joins nearly 400
organizations and institutions across the NIH stakeholder community to
strongly support the Ad Hoc Group for Medical Research recommendation
that NIH receive a program level of at least $46.1 billion. This
funding level would allow for meaningful growth above inflation in the
base budget that would expand NIH's capacity to support promising
science in all disciplines.
While we are grateful for Congress's ongoing commitment to NIH as a
top national priority through the regular appropriations process, we
also urge the inclusion of emergency supplemental investments for the
NIH as Congress considers future legislation to promote the nation's
physical, health, and economic resilience to the COVID-19 pandemic.
The pandemic's impact on biomedical research has been serious and
far-reaching. Researchers in every state were forced to suspend many
laboratory activities for their own personal safety and to comply with
physical distancing guidelines. The closure of many research facilities
impacted trainees, technicians, early-stage investigators, and
established investigators alike, preventing the research workforce from
maintaining momentum toward better prevention, treatments, diagnostics,
and cures for diseases such as blood cancers, sickle cell disease, and
other hematologic diseases and conditions. While many institutions have
been implementing plans to ramp this work back up again as safely as
possible, challenges associated with the disruptions continue to
linger. For example, certain types of research--such as clinical trials
and other research projects with human participants--have been slower
to recover. Additionally, as a result of the lags, we risk undoing
progress we have made in recent years in strengthening the research
workforce, including among women, underrepresented minorities, and
early-career investigators and others at a pivotal point in their
career trajectories.
To enable NIH to mitigate the pandemic-related disruptions without
foregoing promising new science, ASH strongly supports emergency
funding for federal research agencies as outlined in the bipartisan
Research Investment to Spark the Economy (RISE) Act (H.R. 869/S. 289),
including $10 billion for NIH.
FY 2022 Request: Centers for Disease Control and Prevention (CDC)
The Society also recognizes the important role of the CDC in
preventing and controlling clotting, bleeding, and other hematologic
disorders. This is especially important for improving the care and
treatment of individuals with sickle cell disease (SCD).
Sickle cell disease is an inherited, lifelong disorder affecting
approximately 100,000 Americans. Individuals with the disease produce
abnormal hemoglobin which results in their red blood cells becoming
rigid and sickle-shaped, causing them to get stuck in blood vessels and
block blood and oxygen flow to the body, which can cause severe pain,
stroke, organ damage, and in some cases premature death. Though new
approaches to managing SCD have led to improvements in diagnosis and
supportive care, many people living with the disease are unable to
access quality care and are limited by a lack of effective treatment
options.
The Sickle Cell Disease and Other Heritable Blood Disorders
Research, Surveillance, Prevention, and Treatment Act of 2018 (P.L.
115-327) authorized CDC, through its Sickle Cell Data Collection
program, to award grants to states, academic institutions, and non-
profit organizations to gather information on the prevalence of SCD and
health outcomes, complications, and treatment that people with SCD
experience. Currently eleven states participate in the data collection
program. Funding through the CDC Foundation has allowed Georgia and
California to collect data since 2015; seven additional states
(Alabama, Indiana, Michigan, Minnesota, North Carolina, Tennessee, and
Wisconsin) were able to begin their programs in FY 2021 with the $2
million in funding provided by Congress in the FY 2021 Consolidated
Appropriations Act. In early March 2021, the program expanded to
Colorado and Virginia with additional funding from the CDC Foundation.
These eleven states are estimated to include just over 35% of the U.S.
SCD population.
ASH thanks Congress for the $2 million provided for the data
collection program in FY 2021 and for the Administration's request for
$2 million in funding for the program in FY 2022. The Society strongly
supports providing CDC with at least $5 million in FY 2022 to continue
to phase in the data collection program in the currently participating
states and to allow for an expansion to additional states with the goal
of covering the majority of the U.S. SCD population over the next five
years.
FY 2021 Request: Health Resources and Services Administration (HRSA)
Finally, ASH supports the Administration's funding requests for the
SCD programs within HRSA's Maternal and Child Health Bureau, including
$7.205 million for the SCD Treatment Demonstration Program (SCDTDP) and
$5 million for the SCD Newborn Screening Program, which is part of
HRSA's Special Projects of Regional and National Significance (SPRANS)
program. The grantees funded by these programs work to improve access
to quality care for individuals living with SCD and sickle cell trait.
The SCDTDP funds five geographically distributed regional SCD grants
that support SCD providers to increase access to high quality,
coordinated, comprehensive care for people with SCD, while the SCD
Newborn Screening Program provides grants to support the comprehensive
care for newborns diagnosed with SCD. ASH also supports the inclusion
of language in the report accompanying the FY 2022 appropriations bill
asking HRSA to provide Congress with a report detailing how the Sickle
Cell Disease Treatment Demonstration Program is supporting the growth
of comprehensive sickle cell disease centers.
Thank you again for the opportunity to submit testimony. Please
contact ASH Senior Manager, Legislative Advocacy, Tracy Roades at
[email protected], if you have any questions or need further
information concerning hematology research or ASH's FY 2022 requests.
______
Prepared Statement of the American Society of Human Genetics
The American Society of Human Genetics (ASHG) thanks the
Subcommittee for its continued strong support and leadership in funding
the National Institutes of Health (NIH). The $1.25 billion increase
provided for Fiscal Year (FY) 2021 reinforces our nation's commitment
to the health and well-being of all Americans--at a time when investing
in biomedical research and scientific innovation is most needed to
defeat the COVID-19 pandemic. ASHG urges the Subcommittee to
appropriate $46.1 billion for NIH in FY 2022.
ASHG was delighted to see President Biden propose a major increase
to NIH's budget in FY 2022. We note that President Biden proposes a
significant investment for the creation of a new Advanced Research
Projects Agency for Health (ARPA-H). We look forward to learning more
about ARPA-H and how research on human genetics and genomics might play
a role in its mission.
saving lives: genetics research in the fight against covid-19
Less than a year after the first case of COVID-19 was reported, the
U.S. Food and Drug Administration (FDA) authorized the use of two
COVID-19 vaccines.\1\ This record speed in vaccine development was
built on decades of research and scientific knowledge, including NIH-
funded basic research and private investments that have led to rapid
and inexpensive DNA sequencing technologies.\2\ Our ability to quickly
and inexpensively analyze the genome of the SARS--CoV-2 virus has been
crucial for developing diagnostics and vaccines, testing, tracking
variants, and trying to understand the range of responses to infection.
NIH Director Dr. Francis Collins noted that the ability to rapidly
sequence the new coronavirus ``...made it possible within 24 hours for
the first vaccine design to get started!'' \3\
---------------------------------------------------------------------------
\1\ https://covid19.nih.gov/research-highlights/vaccine-
development.
\2\ Ibid.
\3\ https://www.forbes.com/sites/billfrist/2021/01/20/nih-director-
dr-francis-collins-connecting-the-dots-from-the-human-genome-project-
to-the-covid-19-vaccine/?sh=36f948a27543.
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Human geneticists across the world mobilized quickly to try to
understand why some individuals were asymptomatic while others suffered
from severe disease, including so-called ``Long COVID.'' Early data
supports that genetic differences between individuals play a part in
determining susceptibility to the disease. The COVID-19 Host Genetics
Initiative and the COVID-19 Human Genetics Effort brought together
researchers from dozens of countries to share resources and data to
understand how human genetics affects COVID-19 susceptibility,
severity, and outcomes.\4,5\
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\4\ https://www.covid19hg.org/partners/.
\5\ https://www.covidhge.com/.
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return on investment: genetics research benefits the economy
The pandemic has demonstrated that federally funded research is
critical for us to return to normalcy and recover economically. In
addition, investments in research and development continue to be a
strong driver of economic activity overall. A new study commissioned by
ASHG and conducted by TEConomy Partners highlights the growth of a
dynamic ecosystem derived from human genetics research, and that the
development and manufacturing of genomic technologies, diagnostics and
therapeutics, and the associated healthcare services, ``generate
substantial U.S. economic activity and support a large volume of jobs
across the nation.'' \6\ The report estimates that the human genetics
and genomics sector supports 850,000 jobs and generates $265 billion in
total economic activity annually,\7\ demonstrating that this sector has
grown around five-fold in the last decade. Beyond the economic impact,
the study also catalogues the many ways in which human genetics and
genomics is being integrated into routine clinical care across a broad
range of diseases.\8\ Key data from the report are shown below.
---------------------------------------------------------------------------
\6\ Tripp, S., and Grueber, M. 2021. The Economic Impact and
Functional Applications of Human Genetics and Genomics. https://
www.ashg.org/wp-content/uploads/2021/05/ASHG-TEConomy-Impact-Report-
Final.pdf.
\7\ Ibid.
\8\ Ibid.
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genetics & genomics: striving for equity
The COVID-19 pandemic has disproportionately affected racial and
ethnic minorities in the U.S., reinforcing that there are social
factors in this country that cause major health disparities.\9\ It is
imperative that the application of genetic science in healthcare does
not worsen existing health disparities, but instead advances health to
benefit all Americans. Indeed, NIH-funded research has demonstrated how
genetics and genomics research can be a tool for health equity through
deliberate inclusion and participation of individuals from diverse
groups. As genetics research is foundational to our understanding of
human biology, gleaning the full scope of genetic variation will
improve both healthcare and health equity. Inclusion of populations
from diverse ancestries in studies is revealing novel insights about
drug responses, diagnostic accuracy, and disease risk, demonstrating
the need for increased diversity in research studies and clinical
trials.\10\ In ensuring broad cohort diversity in biomedical research,
we need to consider all types of diversity, including engagement with
both urban and rural communities, and taking into account social
demographics such as gender, age, and economic status.
---------------------------------------------------------------------------
\9\ https://www.cdc.gov/coronavirus/2019-ncov/community/health-
equity/racial-ethnic-disparities/index.html.
\10\ Collins, F., Doudna, J.A., Lander, E., and Rotimi, C.N. Human
Molecular Genetics and Genomics--Important Advances and Exciting
Possibilities. N.Engl.J.Med 2021. 384:1-4.
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The Society commends NIH's efforts to advance diversity and equity
in research, which are made possible by the strong support of this
Subcommittee in providing robust funding for the NIH. The great strides
made by the All of Us Research Program in having its research cohort
reflect the diversity of the United States is one such example.\11\
Furthermore, UNITE, NIH's new initiative to address ``racial equity in
the biomedical research workforce'' and ``long-standing health
disparities and issues related to minority health inequities in the
United States'' \12\ comes at a crucial time for our nation.
---------------------------------------------------------------------------
\11\ https://allofus.nih.gov/.
\12\ https://www.nih.gov/ending-structural-racism/unite.
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America's greatest asset is its people--all of its people. From the
research workforce to research participants, increasing diversity is
essential if we are to realize the full promise of genomics research
and the equitable application of genetic discoveries in healthcare and
society. Sustained budget increases for NIH are necessary to fund
programs that emphasize diversity and equity in the workforce and that
broaden participation by the public in research.
nih funding for the future
The COVID-19 pandemic caused unprecedented disruptions to the
biomedical research enterprise in 2021. This was especially true in the
human genetics and genomics community, where researchers either closed
laboratories or repurposed their genome sequencing machines for
performing SARS-CoV-2 testing, tracking and tracing. Strong funding is
needed in FY2022 to help the workforce recover.
ASHG joins its fellow members of the Federation of American
Societies for Experimental Biology (FASEB) and the Ad Hoc Group for
Medical Research in recommending a $46.1 billion base budget for NIH
for FY 2022. This funding level would allow NIH's base budget to keep
pace with inflation, specifically the biomedical research and
development price index, and support crucial research on human genetics
and genomics across all of the NIH's 27 Institutes and Centers.
The American Society of Human Genetics (ASHG), founded in 1948, is
the primary professional membership organization for human genetics
specialists worldwide. The Society's nearly 8,000 members include
researchers, clinicians, genetic counselors, nurses and others who have
a special interest in the field of human genetics.
[This statement was submitted by Gail Jarvik, MD, PhD, President,
American
Society of Human Genetics.]
______
Prepared Statement of the American Society of Nephrology
On behalf of the more than 37 million Americans living with kidney
diseases, the American Society of Nephrology respectfully requests that
in the Office of the Secretary of Health and Human Services (IOS),
General Department Management, $25 million be included for KidneyX, a
public-private partnership to accelerate innovation in the prevention,
diagnosis, and treatment of kidney diseases, in the Fiscal Year (FY)
2022 Labor, Health and Human Services, Education and Related Agencies
Appropriations bill.
More than 37 million people in the United States are living with
kidney diseases, and nearly 800,000 have kidney failure, for which
there is no cure. This under-recognized epidemic disproportionately
affects communities of color. For instance, Black Americans comprise 13
percent of the U.S. population but represent 33 percent of Americans
receiving dialysis, the most common therapy for kidney failure.
The COVID-19 pandemic is especially deadly for kidney patients.
Americans with kidney diseases are among the most at risk among
Medicare beneficiaries for severe outcomes from COVID-19--including
hospitalization and death,i,ii,iii,iv and COVID-19 damages the kidneys
of as many as 40-50% of all hospitalized COVID-19 patients, even those
without a prior history of kidney diseases.v,vi
The status quo for treating and managing kidney diseases is far too
costly to taxpayers to continue without intervention. Before the COVID-
19 pandemic, Medicare dedicated $130 billion, or 25 percent of all
traditional Medicare fee-for-service spending, to the care of all
kidney diseases, including $50 billion, or 7 percent of Medicare fee-
for-service spending, to manage kidney failure alone. Relative to other
chronic diseases with comparable federal spending and disease burden,
people with kidney diseases have had a lack of innovation in the
prevention, diagnosis, and treatment of kidney diseases, but hope is on
the horizon: KidneyX is attracting a new generation of innovators and
investors and transforming kidney care.
KidneyX is incentivizing innovators to fill unmet patient needs
through a series of prize competitions, de-risking the
commercialization process by fostering coordination among federal
agencies and creating a sense of urgency on behalf of patients and
families. To date, KidneyX has provided funding to more than 50
innovators across 4 prize competitions for solutions ranging from
patient-generated solutions that improve quality of life while living
with kidney diseases to steps toward paradigm-shifting technologies
such as a wearable or implantable artificial kidney. In 2020, KidneyX
awarded the COVID-19 Kidney Care Challenge to identify solutions that
will reduce the risk of COVID-19 to kidney patients and launched the
Artificial Kidney Prize to accelerate the development of an artificial
kidney. Winners of Phase 1 of the Artificial Kidney Prize will be
announced in September 2021. FY 22 funding will support continued
development of an artificial kidney through Phase 2 and 3 of the
Artificial Kidney Prize and other innovations to catalyze further
private investment in meeting the long unmet needs of this underserved
population.
Winning innovations awarded KidneyX prizes have supported
innovators in 22 states, including those highlighted below:
--Applying advances in science and technology to improve current
kidney failure therapies, such as nanomaterials to reduce
infections in dialysis grafts and an innovative catheter which
might exponentially reduce infections in the provision of
dialysis, both seeded through the Redesign Dialysis Phase 1 and
Redesign Dialysis Phase 2 prize competitions
--Patient generated solutions to better manage their care, such as
clothing which provides health care staff easy access to
dialysis ports without having to remove or scrunch up clothing,
seeded through the Patient Innovator Challenge
--Novel methods for maintaining kidney health during the pandemic
such as a ``Good Humoral Immunity Truck'' to deliver vaccines
to patients in hard-to-reach communities, and a new reusable N-
95 respirator to aid in the high-touch care setting of a
dialysis unit, seeded through the COVID-19 Kidney Care
Challenge
--New technologies as innovative treatment options, such as an
implantable silicon filter cartridge that mitigates the need
for dialysis needles or a method to grow human kidney cells on
animal kidney scaffolds that could increase the number of
transplantable organs, both seeded through the Redesign
Dialysis Phase 1 and Redesign Dialysis Phase 2 prize
competitions
A bipartisan achievement, KidneyX was first unveiled as a concept
at the 2016 Obama White House Organ Summit and was a central pillar of
Former President Donald J. Trump's July 2019 Executive Order on
Advancing American Kidney Health. KidneyX is a true public-private
partnership: the private sector has already committed $25 million to
KidneyX and is committed to matching federal funding to achieve a total
$250 million in the first 5 years. KidneyX has received $10 million
since FY 20 in enacted appropriations. Since its inception, KidneyX has
demonstrated the success of its public-private prize funding model,
delivering on its mission of accelerating innovation in kidney care,
attracting new innovators and investors to the kidney space, and
broadening the availability of novel ideas and capital to improve the
lives of the 37 million Americans with kidney disease.
In light of this strong track record, we respectfully request that
the Labor-HHS Subcommittee continue its commitment by appropriating $25
million in FY 2022 for KidneyX, catalyzing private sector investment in
kidney health including to develop the world's first artificial kidney.
In addition, we also ask that you include the following language in the
report accompanying your Committee's appropriations bill:
The Committee is aware that more than 37 million people in the
United States are living with kidney diseases, and for nearly 800,000
of those individuals, the diseases progress to kidney failure,
requiring access to dialysis or kidney transplantation to live. The
Committee notes that kidney failure alone accounted for more than 7% of
Medicare spending (approximately $50 billion) in CY 2018, yet
therapeutics for kidney failure remain limited and 50% of patients
starting dialysis, the most common therapy for kidney failure, will die
within 5 years.
Given the high cost of kidney disease in terms of health
consequences and federal spending, the Committee recommends that a
total of $25,000,000 be added to the funds for the Office of the
Secretary in FY 2022 and that those funds be made available to support
KidneyX. These funds will accelerate the development and adoption of
the artificial kidney and other novel therapies and technologies that
improve the diagnosis and treatment of people with kidney diseases.
Thank you for your consideration of this important request. Should
you have questions or need additional information, do not hesitate to
contact Zach Kribs, Senior Government Affairs Specialist of the
American Society of Nephrology, at (202) 618-6991 or zkribs@asn-
online.org.
about the american society of nephrology
The American Society of Nephrology is a 501(c)(3) non-profit, tax-
exempt organization that leads the fight against kidney disease by
educating the society's more than 21,000 nephrologists, scientists, and
other healthcare professionals, advancing research and innovation,
communicating new knowledge, and advocating for the highest quality
care for patients. For more information, visit www.asn-online.org.
---------------------------------------------------------------------------
\1\ https://www.cms.gov/newsroom/press-releases/cms-proposes-
medicare-payment-changes-support-innovation-and-increased-access-
dialysis-home-setting.
\2\ https://www.cms.gov/files/document/medicare-covid-19-data-
snapshot-fact-sheet.pdf.
\3\ Cheng Y, Luo R, Wang K, et al. Kidney disease is associated
with in-hospital death of patients with COVID-19. Kidney Int.
2020;97(5):829-838. doi:10.1016/j.kint.2020.03.005.
\4\ Ng JH, Hirsch JS, Wanchoo R, et al. Outcomes of patients with
end-stage kidney disease hospitalized with COVID-19. Kidney Int.
2020;98(6):1530-1539. doi:10.1016/j.kint.2020.07.030.
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v Birkelo, B C. et al. Comparison of COVID-19 versus influenza on
the incidence, features, and recovery from acute kidney injury in
hospitalized United States Veterans. Kidney Int. 2020;0(0). doi.org/
10.1016/j.kint.2021.05.029
vi Chan L, et al. AKI in Hospitalized Patients with COVID-19. JASN.
2021;32(1):151-160. doi: 10.1681/ASN.2020050615
[This statement was submitted by Zachary Kribs, Senior Government
Affairs Specialist, American Society of Nephrology.]
______
Prepared Statement of the American Society of Nephrology, the American
Society of Pediatric Nephrology, and the National Kidney Foundation
On behalf of more than 37 million children, adolescents, and adults
living with chronic kidney diseases (CKD) in the United States, the
American Society of Nephrology, the American Society of Pediatric
Nephrology, and the National Kidney Foundation request $46.11 billion
for the National Institutes of Health in FY 2022, an increase of 7.3%
that will provide real growth of 5% after accounting for the biomedical
research and development price index of 2.3%, and request an increase
for the National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) that is at least proportional to the increase for NIH.
Greater investment in kidney research is needed to advance
understanding of the under-recognized public health epidemic of kidney
diseases and address the disproportionate impact of COVID-19 and racial
disparities experienced by Americans living with kidney diseases.
For nearly 800,000 Americans, kidney diseases progress to kidney
failure, a life-threatening condition for which there is no cure.
Kidney failure is most commonly managed by in-center hemodialysis, a
therapy that has changed little in the 50 years since its development
with a survival rate worse than most cancers (and comparable with brain
cancers), or a kidney transplant, the optimal therapy for most patients
but often inaccessible due to a shortage of organs and inequities in
our nation's transplant health system. Both therapies involve
suppression of the immune system and put patients at increased risk of
communicable diseases--especially COVID-19--and significant racial and
ethnic disparities exist in terms of therapy access and patient
outcomes.
Almost 50 years ago, Congress made a commitment to treat all
Americans with irreversible kidney failure through the Medicare End-
Stage Renal Disease (ESRD) Program regardless of age. Medicare spends
$130 billion on the care of people with kidney diseases, or 22% percent
of all Medicare fee-for-service spending. Of this amount, $49 billion
is spent managing the care of people with kidney failure. Individuals
with kidney failure represent only 1% of Medicare beneficiaries but
comprise 7.2% of Medicare fee-for-service expenditures. Despite this
enormous societal cost, kidney disease research supported by NIH is
equivalent to one-half of one percent of Medicare fee for service
expenditures for beneficiaries with kidney diseases and kidney failure.
People with kidney diseases face stark racial and socioeconomic
disparities in disease burden and access to care. Black Americans (17%)
and Hispanic Americans (15%) are more likely to have kidney diseases
than white Americans (14%) and these disparities increase as kidney
diseases progress to kidney failure: Black Americans are 3.5 times more
likely than white Americans to have kidney failure and Hispanic
Americans are 1.5 times more likely to have kidney failure than white
Americans. Disparities in prevalence and outcomes are due to multiple
factors including lack of access to care, social determinates of
health, and systemic racism. Greater investment in research is needed
to increase understanding about the underlying causes of disparities
and generate interventions to address them.
Kidney disease patients also are at an increased risk of severe
outcomes from COVID-19, such as hospitalization and death, due to their
vulnerable physical conditions, multiple chronic conditions, weakened
immune systems, and for those on dialysis, the need to leave home three
times a week to receive care in a facility with other vulnerable
patients. Further, COVID-19 has been shown to cause kidney damage in as
many as 50% of hospitalized COVID-19 patients, even those without a
previous history of kidney disease, often requiring emergency dialysis.
While the long-term effects of COVID-19 on kidney health and function
are under investigation, it is likely that COVID-19 will lead to an
influx of new patients with kidney diseases, and that some of these
patients will require ongoing care. Despite the severe impact of COVID-
19 on people with kidney diseases and kidney health, no dedicated
COVID-19 funding has been provided to NIDDK to-date, forcing research
of the impact of COVID-19 on kidney health to come at the expense of
existing research projects.
Many kidney disease patients also experience comorbidities such as
cardiovascular disease (including heart attack and stroke), anemia,
bone disease, hypertension, and diabetes. Pediatric kidney disease
patients often have rare medical conditions with different needs
associated with them than typical adult patients, which must be better
understood. Greater investment in kidney research should be an urgent
priority to slow disease progression, improve treatment, reduce
morbidities, and improve patients' quality of life. NIDDK-funded
scientists have produced several major breakthroughs in the past
several years that require further investment to stimulate therapeutic
advancements. For example, NIDDK launched the Kidney Precision Medicine
Project that will pinpoint targets for novel therapies-setting the
stage for personalized medicine in kidney care. However, additional
funding is needed to accelerate these and other novel opportunities to
improve the care of patients with kidney disease. Better understanding
of the natural history of kidney disease and its progression in adults
and children could lead to earlier detection and better treatments to
slow disease progression and perhaps prevent irreversible kidney
failure.
Thank you again for your leadership, and for your consideration of
our request. Should you have any questions or wish to discuss kidney
disease research in more detail, please contact Erika Miller with the
American Society of Pediatric Nephrology at [email protected]; Rachel
Meyer with the American Society of Nephrology at [email protected];
or Lauren Drew with the National Kidney Foundation (NKF) at
[email protected].
about the american society of nephrology
The American Society of Nephrology is a 501(c)(3) non-profit, tax-
exempt organization that leads the fight against kidney disease by
educating the society's more than 21,000 nephrologists, scientists, and
other healthcare professionals, advancing research and innovation,
communicating new knowledge, and advocating for the highest quality
care for patients. For more information, visit www.asn-online.org.
about the american society of pediatric nephrology
Founded in 1969, the American Society of Pediatric Nephrology is a
professional society composed of pediatric nephrologists whose goal is
to promote optimal care for children with kidney disease and to
disseminate advances in the clinical practice and basic science of
pediatric nephrology. ASPN currently has over 600 members, making it
the primary representative of the Pediatric Nephrology community in
North America.
about the national kidney foundation
The National Kidney Foundation is the largest, most comprehensive,
and longstanding patient-centric organization dedicated to the
awareness, prevention, and treatment of kidney disease in the U.S. In
addition, NKF has provided evidence-based clinical practice guidelines
for all stages of chronic kidney disease (CKD), including
transplantation since 1997 through the National Kidney Foundation
Kidney Disease Outcomes Quality Initiative (KDOQI). For more
information about NKF, visit www.kidney.org
[This statement was submitted by Sharon Pearce, Senior Vice
President, Government Relations, National Kidney Foundation, American
Society of Nephrology, American Society of Pediatric Nephrology, and
National Kidney Foundation.]
______
Prepared Statement of the American Society of Plant Biologists
On behalf of the American Society of Plant Biologists (ASPB), we
would like to thank the Subcommittee for its support for the National
Institutes of Health (NIH). ASPB and its members strongly believe that
sustained investments in scientific research are a critical component
of economic growth, job creation, and innovation for our nation. ASPB
supports continued robust funding for NIH in fiscal year (FY) 2022 and
asks that the Subcommittee encourage increased support for plant-
related research with relevance to health within the agency.
ASPB, founded in 1924 as the American Society of Plant
Physiologists, was established to promote the growth and development of
plant biology, to encourage and publish research in plant biology, and
to promote the interests and professional advancement of plant
scientists in general. ASPB members educate, mentor, advise, and
nurture future generations of plant biologists; they work to enhance
understanding of plant biology and its impacts on public health and
wellbeing, as well as science in general, in K-16 schools and among the
general public; they advocate in support of plant biology research;
work to convey the relevance and importance of plant biology; and they
provide expertise in policy decisions world-wide. Overall, ASPB
members, as representatives of the society, work to disseminate
information and to excite future generations about plant sciences,
especially through ASPB's advocacy, outreach activities, conferences,
and publications.
plant biology research and america's future
Among many other functions, plants are the building blocks at the
base of the food chain upon which all life depends. Importantly, plant
research is also helping make many fundamental contributions to the
study of human health, including that of a sustainable supply and
discovery of plant-derived pharmaceuticals, nutriceuticals, and
alternative medicines. One example is the antimalarial compound
artemisinin, purified from sweet wormwood plants, whose biosynthetic
pathway was defined and transplanted into yeast to create a low-cost
source of this pharmaceutical for the developing world. Plants are
potential resources to produce vaccines against infectious diseases
such as Ebola, hepatitis B, cholera, and coronavirus. At least one
plant-derived COVID-19 vaccine candidate, developed by GlaxoSmithKline
and Medicago, is already in phase III clinical trials and could be a
valuable asset in ending the COVID-19 pandemic.\1\ Nearly 120 pure
compounds extracted from plants are used globally in medicine, hinting
at the significant possibilities for future discoveries applicable to
human health, agriculture, and manufacturing.\2\ Plant research also
contributes to the continued, sustainable, development of better and
more nutritious foods and the understanding of basic biological
principles that underpin improvements in public health and human
nutrition.
---------------------------------------------------------------------------
\1\ https://www.medicago.com/en/media-room/medicago-and-gsk-start-
phase-3-trial-of-adjuvanted
-covid-19-vaccine-candidate/.
\2\ Page 19, Decadal Vision, https://
plantsummit.files.wordpress.com/2013/07/plantsciencedeca
dalvision10-18-13.pdf.
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plant biology and the national institutes of health
Plant science and many of our ASPB member research activities have
enormous positive impacts on the NIH mission to pursue ``fundamental
knowledge about the nature and behavior of living systems and the
application of that knowledge to extend healthy life and reduce the
burdens of illness and disability.'' In general, plant research aims to
improve the overall human condition-be it food, nutrition, medicine,
clean air, or agriculture-and the benefits of plant science research
readily extend across disciplines. In fact, plants are often the ideal
model systems to advance our ``fundamental knowledge about the nature
and behavior of living systems'' as they provide complexity of multi-
cellular organisms including humans while affording ease of genetic
manipulation, a lesser regulatory burden, and maintenance requirements
that are less expensive than those required for the use of animal
systems.
Fundamental Biological Research.--Many fundamental biological
components and mechanisms are shared by plants and animals. Examples
include but are not limited to genetic principles, cell division, host-
pathogen interactions, organism-environment interactions, polar growth,
DNA methylation and repair, innate immunity signaling, and circadian
(biological) rhythms. Fundamental hereditary laws were derived from the
study of garden peas. The phenomenon of RNA interference, which has
application in gene therapies for human disease, was first discovered
in plants. Contributions of plant genetics to advancing human health
were exemplified when Barbara McClintock, an American scientist and
cytogeneticist, was awarded the Nobel Prize in Physiology for the
discovery of ``jumping genes'' or transposable elements in maize, which
function as mobile DNA sequences within a genome. Similar elements
constitute 40% or more of the human genome. More recently, plants are
among organisms that have been used to develop revolutionary
technologies such as gene editing (CRISPR), capable of precisely
editing genomes to potentially correct mutations that lead to disease.
These technologies will benefit plant biology and agriculture to
produce healthy food and feed the world. Furthermore, many treatments
and therapies are based on metabolites derived from plants, which
exemplifies the application of plant biology research to improving
human health. These important discoveries, among many others in science
and technology, reflect the fact that some of the most important
biological discoveries applicable to human physiology and medicine can
find their origins in plant-related research endeavors.
Health and Nutrition.--Plant biology research is also central to
the application of basic knowledge to ``extend healthy life and reduce
the burdens of illness and disability.'' Without good nutrition, there
cannot be good health. Indeed, a World Health Organization study on
childhood nutrition in developing countries concluded that over 50% of
child deaths under the age of five could be attributed to
malnutrition's effects on weakening the immune system and exacerbating
common illnesses such as respiratory infections and diarrhea; \3\ this
is expected to worsen as global populations increase. One example of
how advances in plant biology have been applied to tackling nutritional
deficiencies is golden rice, designed to address vitamin A deficiency
and reduce blindness risk in vulnerable children. Golden rice was
engineered to include additional genes that switch on production of
beta-carotene, and a bowl of this golden rice can provide 60% of a
child's daily requirement of vitamin A to prevent blindness.
Significant advances have also been made in the production of value-
added and resilient crops capable of withstanding drought, natural
disasters, and extreme temperature shifts. DroughtGard Hybrid corn,
engineered to maximize water storage, usage, and crop yield in
unfavorable drought conditions, is just one example of the progress
being made towards health, nutrient, and food security through
innovations made in plant science.
---------------------------------------------------------------------------
\3\ https://www.who.int/bulletin/archives/78(10)1207.pdf.
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Obesity, cardiac disease, and cancer also take a striking toll
globally. Research to improve and optimize concentrations of plant
compounds known to have, for example, anti-cancer properties, will help
in reducing disease incidence rates. Ongoing development of crop
varieties with value-added nutraceutical content is an important
contribution that plant biologists are making toward realizing a common
goal of personalized, preventative medicine.
Drug Discovery.--Plants are fundamentally important as sources of
both extant drugs and drug discovery leads. In fact, 60% of anti-cancer
drugs in use within the last decade are of natural product origin-
plants being a significant source. An excellent example is the anti-
cancer drug Taxol, which was discovered as an anti-carcinogenic
compound from the bark of the Pacific yew tree through collaborative
work involving scientists at the NIH National Cancer Institute and
plant natural product chemists. While the pharmaceutical industry has
invested some efforts on natural products-based drug discovery,
research support from NIH remains a crucial component of the drug
development pipeline. Multidisciplinary teams of plant biologists,
bioinformaticians, and synthetic biologists are being assembled to
develop new tools and methods for natural products discovery and
creation of new pharmaceuticals. We appreciate NIH's current investment
into understanding the biosynthesis of natural products through
transcriptomics and metabolomics of medicinal plants and support more
funding opportunities similar to the ``Genomes to Natural Products''
which will enhance new plant-related medicinal research.
conclusion
Plants play unique and pivotal roles in nutrient and health,
agriculture, and food supply, as well as basic science discoveries
directly or indirectly relevant to public health. Plant biology
research integrates seamlessly and synergistically with many different
disciplines and core missions at NIH. As such, ASPB asks the
Subcommittee to provide continued robust funding for NIH and direct the
agency to support additional plant research in order to continue to
pioneer new discoveries and new methods with applicability and
relevance in biomedical research. Thank you for your consideration of
ASPB's testimony. For more information about ASPB, please see
www.aspb.org.
[This statement was submitted by Crispin Taylor, Ph.D., Chief
Executive Officer, American Society of Plant Biologists.]
______
Prepared Statement of the American Speech-Language-Hearing Association
Chairwoman Murray and Ranking Member Blunt: The American Speech-
Language-Hearing Association (ASHA) thanks you for the opportunity to
submit testimony on the fiscal year (FY) 2022 Labor-HHS-Education
funding bill. My name is A. Lynn Williams, PhD, CCC-SLP, ASHA's
President for 2021. As the Subcommittee begins its work on this
critical legislation, I offer support for the following funding
requests:
--$15.5 billion for Individuals with Disabilities Education Act
(IDEA) Part B State Grants, $598 million for IDEA's Part B
Section 619 Preschool Grants, and $732 million for IDEA Part C
Infants and Toddlers with Disabilities within the Department of
Education.
--$11,851,488 for the Centers for Disease Control and Prevention
(CDC) and $19,522,758 for the Health Resources and Services
Administration (HRSA) for the Early Hearing Detection and
Intervention programs within the Department of Health and Human
Services. In addition, ASHA urges the Subcommittee to include
report language to address hearing health care disparities in
medically underserved communities.
--$15.5 million increase in funding for the National Institute on
Deafness and Other Communications Disorders (NIDCD) at the
National Institutes of Health (NIH), while ensuring that NIDCD
receives an equitable funding share from any increases to NIH
funding in FY 2022.
--$122,970,000 for the National Institute on Disability, Independent
Living, and Rehabilitation Research (NIDILRR) at the
Administration for Community Living (ACL) within the Department
of Health and Human Services.
individuals with disabilities education act
ASHA thanks members of the Subcommittee for increasing funding for
the Individuals with Disabilities Education Act (IDEA) last year.
Children and youth (ages 3-21) receive special education services and
related services under IDEA Part B, and infants and toddlers (birth-2
years old) with disabilities and their families receive early
intervention services under IDEA Part C. Congress must continue to make
appropriate investments in IDEA to ensure children with disabilities
receive the free appropriate public education (FAPE), which they are
entitled to under law. A substantial increase in funding for IDEA is a
step toward fulfilling the promise that Congress made to fund 40% of
the average per-pupil expenditure in public elementary and secondary
schools. This critical program serves more than 6.5 million children in
our nation's schools, including students with communication
disorders.\1\ ASHA appreciates the Administration's budget request for
IDEA, which would provide substantial increases for IDEA Part B State
Grants, Section 619 Preschool Grants, and Part C Infants and Toddlers
early intervention services, and that is a significant investment
toward fully funding this program.
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\1\ U.S. Department of Education. (n.d.). About IDEA. https://
sites.ed.gov/idea/about-idea/.
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These resources are essential to support states and local education
agencies in providing FAPE to all students with disabilities. However,
schools and districts continue to grapple with costs associated with
the Coronavirus Disease 2019 (COVID-19) pandemic and require additional
resources to address challenges associated with ensuring continued
education and delivering the services and supports for children with
disabilities. ASHA supports robust funding for IDEA as identified to
ensure students with disabilities can continue to access the services
to which they are entitled.
early hearing detection and intervention program
The Early Hearing Detection and Intervention (EHDI) Act is one of
the nation's most important public health programs, offering early
hearing screening and intervention to all newborns, infants, and young
children in every state and territory. EHDI provides state grants to
develop and support infant hearing screening and intervention programs
through HRSA and requires the CDC to provide surveillance of
screenings, referral to treatment and diagnosis, technical assistance,
and applied research. When the Children's Health Act of 2000 was
passed-which established the state-based universal newborn hearing
screening programs-only 46.5% of newborns were screened.\2\ However,
today approximately 98% of newborns receive an audiologic screening
totaling 4 million infants and children in 2016 alone.\3\ Funding for
hearing screenings and early intervention services has proven to be a
wise investment for the United States' economy and saves the country
approximately $200 million in education costs each year.\4\
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\2\ Centers for Disease Control and Prevention (CDC). (2010).
Summary of infants screened for hearing loss, diagnosed and enrolled in
early intervention, United States, 1999-2008. Atlanta, GA: U.S.
Department of Health & Human Services, CDC; 2010. https://www.cdc.gov/
ncbddd/hearingloss/2008-data/ehdi_1999_2008.pdf.
\3\ Centers for Disease Control and Prevention (CDC). (2018).
Summary of 2016 National CDC EHDI Data. https://www.cdc.gov/ncbddd/
hearingloss/2016-data/01-2016-HSFS-Data-Summary-h.pdf.
\4\ Gross, S.D. (2007). Education cost savings from early detection
of hearing loss: New findings. Volta Voices, 14(6),38-40.
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Fully funding EHDI at its authorized level is critical to ensure
all newborns are screened for hearing loss and receive follow-up
services. Hearing loss is a serious health condition that impacts more
than 34 million Americans, and two to three out of every 1,000 children
in the United States are born with a detectable level of hearing loss
in one or both ears.\5\ Underfunding EHDI may leave thousands of
children with undiagnosed hearing loss and deprive children who are
deaf or hard of hearing from receiving follow-up services that improve
language skills and development as many health care appointments and
treatments have been delayed or canceled due to the COVID-19 pandemic.
When hearing loss is detected late, the critical time for stimulating
the auditory pathways to hearing centers of the brain is lost. Late
hearing loss detection also delays speech and language development
affecting social and emotional growth, academic achievement, and
employment options.
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\5\ National Institute on Deafness and Other Communication
Disorders (NIDCD). (2017). Researchers help uncover a root cause of
childhood deafness in the inner ear using animal model. https://
www.nidcd.nih.gov/news/2017/childhood-deafness-research.
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Children with hearing loss also face significant barriers in
accessing hearing health care services. Variables including
socioeconomic factors, geographic location, medical infrastructure, and
access to social support contribute to delays in diagnosis and
treatment of hearing loss. These disparities particularly impact
members of racial and ethnic minority communities. According to a 2017
study, African American infants are 92% more likely to experience loss
to follow-up than infants from other ethnic groups.\6\ Rural Hispanic
children whose caregivers have low English fluency encounter greater
difficulty accessing these health care services.\7\ According to CDC
data, American Indian and Alaskan Native children enroll in early
intervention services at a rate 26.4% less than their White
counterparts.\8\ The CDC must expand its work to improve surveillance,
ensure access to timely identification of congenital and acquired
hearing loss, and enhance the connection to follow-up services,
particularly among racial and ethnic minority populations. ASHA
supports fully funding EHDI at its authorized level and encourages the
Subcommittee to include the following language in the report on its FY
2022 bill:
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\6\ Bush, M. L., Kaufman, M. R., & McNulty, B. N. (2017).
Disparities in access to pediatric hearing health care. Current opinion
in otolaryngology & head and neck surgery, 25(5), 359-364. https://
doi.org/10.1097/MOO.0000000000000388.
\7\ Ibid.
\8\ Centers for Disease Control and Prevention (CDC). (2020).
Hearing Loss in Children. https://www.cdc.gov/ncbddd/hearingloss/2018-
data/15-screening-demographics.html.
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The Committee recognizes the importance of access to pediatric
hearing health care. The Committee is aware of the significant racial
and ethnic disparities in care facing children with hearing loss, and
the effect unaddressed congenital hearing loss has on communication
skills, psychosocial development, educational progress, and language
development. The Committee encourages the CDC to expand their work to
improve surveillance of state and territorial-based EHDI systems to
ensure access to timely identification of congenital and acquired
hearing loss and develop materials to enhance connection to follow up
services among racial and ethnic minorities, and other medically
underserved populations.
National Institute on Deafness and Other Communication Disorders, and
the National Institute on Disabilities, Independent Living and
Rehabilitation Research
ASHA applauds the Subcommittee's continued efforts to increase
funding for health care research. ASHA strongly supports continued
increases in funding for the National Institute on Deafness and Other
Communications Disorders (NIDCD) at the National Institutes of Health
(NIH), and the National Institute on Disabilities, Independent Living
and Rehabilitation Research (NIDILRR) at the Administration for
Community Living (ACL). NIDCD investments are needed to ensure
groundbreaking research on communication sciences as rehabilitation
continues to evolve and expand. Approximately 46 million Americans have
a communication disorder.\9\ These disorders impact the economy through
costs related to lost productivity, special education services,
rehabilitation needs, health care expenditures, and lost revenue.
Increases in NIDILRR's funding would allow the Institute to support the
wide range of applied research and expand into new areas of emerging
science to support individuals with disabilities. ASHA urges the
Subcommittee to provide necessary funding for NIDCD and NIDILRR to
ensure this research continues and evolves to address the needs of
individuals with communication disorders.
---------------------------------------------------------------------------
\9\ National Institute on Deafness and Other Communication
Disorders (NIDCD). (2019). Mission. https://www.nidcd.nih.gov/about/
mission.
---------------------------------------------------------------------------
conclusion
Thank you for the opportunity to provide this testimony for the
record. ASHA appreciates the Subcommittee's past investments in these
important health and education programs and urges continued support at
the recommended funding levels. These investments are crucial to
ensuring audiologists and speech-language pathologists can meet the
hearing, balance, speech, language, swallowing, and cognition-related
needs of their patients, clients, and especially students who are
receiving special education services in schools.
If you or your staff have any questions, please contact ASHA's
associate director of federal affairs: Erik Lazdins, [email protected],
444 North Capitol St NE,
Washington, DC 20001.
______
Prepared Statement of the American Thoracic Society
summary of fiscal year 2022 appropriations recommendations
_______________________________________________________________________
--ATS urges Congress to provide at least $46.1 billion for the
National Institutes of Health (NIH) for Fiscal Year (FY) 2022,
an increase of $3.2 billion over FY2021.
--$3.94 billion for the National Heart, Lung, and Blood Institute
(NHLBI) at NIH.
--$6.52 billion for the National Institute of Allergy & Infectious
Diseases at NIH.
--$419.9 million for the National Institute on Minority Health and
Health Disparities at NIH.
--$187.9 million for the National Institute of Nursing Research at
NIH.
--$875 million for the National Institute of Environmental Health
Sciences (NIEHS).
--ATS urges Congress to provide $10 billion in funding for the
Centers for Disease Control and Prevention (CDC) for FY 2022.
After decades of under-investment, the COVID-19 pandemic has
revealed that we must strengthen our national, state and local
public health systems and reinvest in the CDC.
--$5 million in funding for the Chronic Disease Education and
Awareness Program
--$225 million in FY 2022 for the CDC's domestic Division of TB
Elimination program and $21 million for the Global TB
program
--$35 million in funding for the National Asthma Control Program at
CDC
--ATS requests $50 million in FY2022 for CDC's Climate and Health
Program
--ATS requests $262.5 million in FY2022 for the Office on Smoking
and Health
--$354.8 million in funding for the National Institute of
Occupational Safety and Health
_______________________________________________________________________
about the american thoracic society
The ATS is a multi-disciplinary society of 16,000 physicians,
scientists, respiratory therapists and nurses dedicated to the
prevention, detection, treatment and cure of pulmonary disease,
critical illness and sleep disordered breathing. Our members treat a
wide range of lung disorders and have been on the frontlines of the
COVID-19 pandemic treating individuals and conducting vital scientific
research to develop diagnostics, treatments, and prevention
interventions for COVID, even as we continue our efforts on other
pulmonary, critical illness and sleep disorders.
ATS urges Congress to provide at least $46.1 billion for NIH for FY
2022
ATS thanks Congress for providing funding for NIH's COVID-19-
related research which helped develop life-saving vaccines and other
important advances. But the evolving pandemic requires the continued
mobilization of research resources to improve our understanding of the
SARS-CoV2 virus and develop new diagnostics, therapeutics, and updated
vaccines to combat new virus variants. African Americans, Native
Americans and other racial and ethnic minorities continue to become
infected and die from COVID-19 at high rates--we must accelerate
efforts to address these disparities and develop prevention and
therapeutic interventions for these and other high-risk populations. In
addition, thousands of Americans who recovered from COVID-19 are now
suffering chronic long-term complications. Studies into the causes,
treatment, and prevention of long-term complications, such as pulmonary
fibrosis, are urgently needed.
Respiratory disease in America is on the rise. Even before the
COVID pandemic, lung disease was the fourth leading cause of death in
the US, driven primarily by chronic obstructive lung disease (COPD).
Despite the rising lung disease burden, lung disease research is
underfunded. Although COPD is the fourth leading cause of death in the
U.S., research funding for the disease is a small fraction of what is
invested for the other leading causes of death, such as heart disease,
cancer, and stroke, as outlined below. Funding for implementation of
the COPD National Action Plan would address this disparity.
ATS urges Congress to provide $3.94 billion for NHLBI
Since 1948, the NHLBI has made important progress in the treatment
and prevention of cardiovascular disease, respiratory diseases, and
blood and sleep disorders. Even with this progress, challenges remain
as these conditions continue to account for more than 1 million
American deaths each year and cost our nation an estimated $479 billion
in medical expenses and lost productivity.
To continue important advances in research, the NHLBI is investing
in prevention programs and developing novel therapies for lung diseases
such as chronic obstructive pulmonary disease (COPD), asthma, cystic
and pulmonary fibrosis and driving precision medicine that is tailored
to individual patient needs through data science.
ATS urges Congress to provide $875 million for NIEHS
NIEHS is the leading institute conducting research to prevent human
illness and disability by understanding how the environment influences
the development and progression of human diseases and illnesses such as
cancer, autism, asthma and autoimmune diseases. Researchers funded by
NIEHS have highly relevant expertise that will aid our response to
COVID-19 and future pandemics through study of mechanisms to protect
health care workers facing occupational exposure to SARS-CoV-2 and
COVID-19, and how environmental exposures such as air pollution impact
individual susceptibility to infection and development and severity of
COVID-19 disease.
ATS urges Congress to provide $10 billion for CDC for FY 2022
In order to halt the COVID-19 pandemic and ensure our preparedness
for future infectious disease outbreaks, it is critical that the CDC
receives sustained annual funding increases. In FY2022, increased CDC
funding is needed to ensure resources for COVID-19 vaccine
distribution, administration and public education, testing, contact
tracing, disease surveillance and targeted community assistance,
including to communities that have been disproportionately impacted by
COVID-19 and remain at high-risk, such as minority populations. More
than 70 percent of CDC's budget goes directly to state public and local
health organizations and academic institutions for programs that
protect public health. CDC programs in chronic disease prevention,
tuberculosis control, asthma, tobacco control and occupational safety
and health are essential to protecting the health of millions of
Americans.
ATS urges Congress to provide $225 million for the Division of TB
Elimination and $21 million for CDC's Global TB program through
the Center for Global Health.
Prior to the COVID-19 pandemic, TB was the leading global
infectious disease killer, killing 1.4 million annually. Every state in
the U.S. reports cases of TB each year. Further, in its 2019 report on
antibiotic resistance, the CDC identified drug resistant TB as a
serious health threat to the nation. CDC estimates that up to 13
million Americans have latent TB infection. These cases, which can be
preventively treated, are the reservoir of future active TB cases.
CDC's domestic TB program has been flat funded since FY2014, leaving
states ill-equipped to manage drug resistant TB and unable to do LTBI
testing and preventive treatment. In addition, we urge NIH to expand
research to develop new tools to address TB.
ATS urges Congress to provide $35 million in funding for the National
Asthma Control Program
An estimated 25 million people in the U.S. have asthma, including 6
million children. Asthma is the most common cause of missed school
days--about 14 million per year. As recently as 2016, 3,274 Americans
died of asthma. About 63% of these deaths were among women.
CDC's asthma program includes the following core functions, 1)
provides state grants for asthma control activities including asthma
tracking and public health interventions, 2) Improves asthma education
and management through coordinated school health programs, and 3)
Conducts public health research to help target and inform asthma
control efforts.
ATS urges Congress to provide $5 million in funding for the Chronic
Disease Education and Awareness Program
In response to advocacy by ATS and disease advocates, in FY2021
Congress created CDC's new Chronic Disease Education and Awareness
program to address chronic diseases such as COPD and sleep disorders.
The program will fund competitive grants focused on public health
initiatives to increase awareness and educate communities on how to
prevent chronic diseases. Program grants can be used to support
national and local implementation of the COPD National Action Plan, by
raising awareness and improving access to COPD care and management and
prevention. The program is funded at $1.5 million in FY2021, and
additional resources are needed to support new cooperative agreements
in meritorious areas. We also urge CDC to include COPD-based questions
to future CDC health surveys, including the National Health and
Nutrition Evaluation Survey (NHANES), the Behavioral Risk Factor
Surveillance System (BRFSS) and the National Health Information Survey
(NHIS).
sleep
Research studies demonstrate that sleep-disordered breathing and
sleep-related illnesses affect an estimated 50-70 million Americans.
The public health impact of sleep illnesses and sleep disordered
breathing is known to include increased mortality, traffic accidents,
cardiovascular disease, and other comorbidities. The ATS recommends a
funding level of $1 million in FY2022 to support activities related to
sleep and sleep disorders at the CDC. The ATS also recommends an
increase in funding for research on sleep disorders at the NHLBI's
Nation Center for Sleep Disordered Research (NCSDR). Thank you for your
consideration of these requests.
[This statement was submitted by Lynn Schnapp, MD, ATSF, President,
American Thoracic Society.]
______
Prepared Statement of the American Urogynecologic Society
The American Urogynecologic Society (AUGS) thanks the Subcommittee
for the opportunity to submit comments for the record regarding our
Fiscal Year 2022 report language recommendations for prioritizing
research on Overactive Bladder and medications commonly prescribed to
treat this condition at the NIH National Institute on Aging and the
National Institute of Diabetes, Digestive and Kidney Diseases. AUGS is
a national medical society whose mission is to promote the highest
quality of care in female pelvic medicine and reconstructive surgery
through excellence in education, research, and advocacy.
Overactive Bladder is a sudden, intense urgency to urinate often
followed by an involuntary loss of urine. It can cause the need to
urinate frequently, and often throughout the night, because of altered
bladder nerve signaling. Overactive Bladder occurs in the absence of a
urinary tract infection or other pathology.
Overactive Bladder affects more than 38 million Americans, and 1 in
every 3 older adults. It is more common with aging and in women.
Overactive Bladder has a significant impact on quality of life and on
the healthcare system. Adults with Overactive Bladder are more likely
to report anxiety and depression, falls, decreased quality of life, and
have 20% higher health care utilization than matched counterparts
without this condition. The Centers for Disease Control and Prevention
estimated in the U.S., the direct and indirect costs of Overactive
Bladder would be approximately $76 billion in 2015 and projected these
costs would account for $82.6 billion of U.S. healthcare costs by 2020.
Anticholinergic medications are commonly prescribed to treat
Overactive Bladder. These therapies are the most studied, most
frequently used, and most often covered by insurance companies as a
treatment for Overactive Bladder. However, there is increasing clinical
evidence suggesting an association between long-term use of
anticholinergic medications and the risk of developing cognitive
impairment and Alzheimer's disease and related dementias (ADRD) in some
patients with Overactive Bladder. In fact, the evidence is compelling
enough that the American Urogynecologic Society's ``Choosing Wisely''
campaign recommends the avoidance of anticholinergic medications to
treat Overactive Bladder in women older than 70.
It is well documented that the prevalence of Overactive Bladder
increases with age. Therefore, as the American population continues to
age over the next few decades, the personal and public health burden of
Overactive Bladder will become more acute. Despite compelling data
suggesting the negative impact of Overactive Bladder medications on
cognitive function, more robust evidence is needed to guide evidence-
based treatment approaches. Thus, current Overactive Bladder
medications must undergo additional study to definitively determine
their impact on cognition and Alzheimer's disease and related dementias
(ADRD) development and to determine if the risks substantially outweigh
the benefits of these therapies.
For these reasons, the American Urogynecologic Society urges the
Subcommittee to adopt the following report language in the report
accompanying the Fiscal Year 2022 Labor-HHS-Education appropriations
bill that directs the National Institutes of Health National Institute
on Aging (NIA) and the National Institute of Diabetes, Digestive and
Kidney Diseases (NIDDK) to study the association between current
medications for Overactive Bladder and Alzheimer's disease and related
dementias (ADRD) in certain patient populations, in order to advance
research resulting in safe and effective treatment initiatives for all
patients with Overactive Bladder.
national institutes of health
National Institute on Aging and National Institute of Diabetes,
Digestive and Kidney Diseases
Overactive Bladder.--The Committee is concerned that
anticholinergic medications commonly prescribed to treat Overactive
Bladder, a condition that affects one in three older Americans, have
been shown in recent studies to increase the risk of developing
Alzheimer's disease and related dementias (ADRD). The Committee
believes that further research of anticholinergic medications as well
as on alternatives to these treatments is urgently needed to establish
certainty regarding the safety of these medications as a treatment
option for Overactive Bladder in older adults. The Committee urges that
the National Institute on Aging (NIA) and the National Institute of
Diabetes, Digestive, and Kidney Diseases (NIDDK) prioritize research
grants and contracts that study the long-term use of anticholinergic
medications and the risk of cognitive impairment and ADRD. The
Committee requests an update on this issue and on research activities
to advance safe and effective alternative treatments for Overactive
Bladder in the fiscal year 2023 Congressional Budget Justification.
Thank you in advance for your favorable consideration of this
report language request and for your support for prioritizing research
to ensure there are safe and effective treatments for the millions of
Americans in this country that suffer from Overactive Bladder.
______
Prepared Statement of the Anti-Defamation League
On behalf of the Anti-Defamation League (ADL), I write to urge
Members of the Subcommittee to adopt legislative and report language
that condemns proposals that would effectively curtail anti-bias
programming in public schools. During 2021 sessions, a number of state
legislatures have considered and adopted proposals that purport to
block the teaching of material that is vaguely characterized as
``divisive concepts,'' or as assigning blame or responsibility or
creating guilt based on race, ethnicity, or sex. We are deeply
concerned that these policies would drastically curb the use and
further development of an essential tool in the effort to eliminate
hate incidents: lessons and programs that teach young people about the
history and institutionalization of hateful ideologies, awareness of
biases, and importance of each person vocally opposing expressions of
prejudice.
Founded in 1913 in response to an escalating climate of anti-
Semitism and bigotry, ADL is a leading anti-hate organization with the
mission of protecting the Jewish people and securing justice and fair
treatment for all. Today, we continue to fight all forms of hate with
the same vigor and passion. A global leader in exposing extremism,
delivering anti-bias education, and fighting hate online, ADL's
ultimate goal is a world in which no group or individual suffers from
bias, discrimination, or hate. To that end, ADL is an advocate for
Holocaust education. We strongly believe that learning about the
Holocaust, and the unchecked anti-Semitism and racism that set the
stage for and sustained it, is one of the best ways to fight prejudice
and discrimination, and to help ensure that genocide and other
atrocities never happen again.
ADL has actively opposed anti-"divisive concepts'' bills and
policies including Texas HB 3979, Arizona SB 1532, Louisiana HB 564,
and New Hampshire HB 544; similar proposals that have advanced or been
enacted in 2021 also include Iowa HF 802, which applies not only to K-
12 schools but also to government agencies and public universities and
was enacted by the legislature in early May 2021; West Virginia HB
2595, which proposes to end state funding for any agencies that promote
``divisive'' concepts or acts; and Oklahoma SB 803, which authorizes
dismissal of teachers for instructing students in disapproved-of ideas
and beliefs about, for example, the fundamentally racist and sexist
nature of American society.
Although these bills vary in their details, their common features
include vagueness, subjectivity, and the singling out of particular
ideas for a prohibition on speech, which constitutes unconstitutional
viewpoint discrimination. In fact, a federal judge has already
determined that plaintiffs were likely to succeed in a First Amendment-
based challenge to a similar federal prohibition adopted by a
subsequently-revoked Executive Order. ADL is acutely dismayed that
these proposals will have, and already have had, the effect of
prompting cautious administrators to cancel or postpone critically
important efforts to expand students' knowledge, experience, and
sensitivity to systemic biases. The Iowa Department of Education, for
example, postponed a conference on social justice and equity in
education originally planned for April 2021, noting publicly that, ``We
are mindful of pending legislation that may impact the delivery and
content of certain topics related to diversity, equity and inclusion.''
Another common feature of recent legislation billed as taking aim
at the spread of ``divisive concepts'' is language that prohibits
teaching that makes an individual ``feel discomfort, guilt, anguish or
any other form of psychological distress because of the individual's
race, ethnicity or sex.'' We are particularly alarmed that this measure
would effectively create a ``heckler's veto'' of critical education in
our public schools. Legitimate Holocaust curricula or educational
programs must necessarily condemn the antisemitic and racist ideology
of the Nazis, as well as Holocaust denial. As a leading authority on
extremism, terrorism, and hate, both foreign and domestic, we also note
that today's white supremacists and neo-Nazis are virulently
antisemitic, racist, xenophobic, misogynistic, homophobic, and do not
consider light-skinned Jews to be ``white people.'' We foresee that
under the rules set forth in these bills, any student or employee who
is white and holds these odious beliefs, whether or not affiliated with
an extremist group, could claim that a Holocaust education program
impermissibly makes them feel discomfort, guilt, anguish, or other
psychological distress because of their white race. The same could be
true for someone holding these beliefs who claims that discussion of
the Holocaust and historical antisemitism constitutes discrimination
based on their German ethnicity or national origin. This concern is not
hypothetical. Only two years ago there was a disturbing issue at a
South Florida public high school involving parents who did not believe
the Holocaust occurred, who succeeded in impacting the school's
delivery of state-mandated Holocaust education.
At a time of rising hate crimes and anti-Semitic incidents, the
need to teach young people who are still forming their beliefs and
principles the universal lessons of the Holocaust, and the devastating
consequences of all forms of bigotry and hate, is acute and urgent.
Anti-bias education and the imparting of honest information about the
historical and social reasons for persistent disparities among people
of different races, ethnicities, religions, genders, sexual
orientations, and abilities are essential elements to the
deconstruction of stratified, discriminatory systems: we simply cannot
create a more just future without examining and confronting our unjust
past and its modern-day footprints. Curricula that identify the
hallmarks of bigotry and bring unconscious prejudices to light not only
bend the moral arc of the universe toward justice, but also teach youth
valuable leadership and problem-solving skills, and ensure that
classroom environments are conducive to every student's progress.
Positive communities that proactively welcome and celebrate inclusion
foster academic and life success.
ADL urges Members of the Subcommittee to protect students' access
to essential education about discrimination, biases, and the
consequences of government and institutional embrace of prejudice by
adopting legislative language that withdraws and withholds federal
funding for public educational agencies and institutions that implement
prohibitions on the teaching of so-called ``divisive concepts,'' to
include histories and present-day indicators of endemic hate and
discrimination against groups of people based on race, ethnicity,
national origin, religion, gender, gender identity, sexual orientation,
and disability. In addition, we urge Members to adopt report language
that notes the need for and benefits of anti-bias education in schools
and that condemns attempts to limit or prohibit anti-bias programming
in schools and other government institutions.
Thank you for your consideration.
[This statement was submitted by Erin Hustings, Director of Govt.
Relations, Civil Rights Anti-Defamation League.]
______
Prepared Statement of the Association for Career and Technical
Education and Advance CTE
Chairwoman Murray, Ranking Member Blunt, and distinguished members
of the subcommittee, on behalf of the Association for Career and
Technical Education (ACTE), the nation's largest not-for-profit
association committed to the advancement of education that prepares
youth and adults for career success, and Advance CTE, the nation's
longest-standing not-for-profit that represents State Directors and
leaders responsible for secondary, postsecondary and adult Career
Technical Education (CTE) across all 50 states and U.S. territories, we
respectfully request that the subcommittee increase funding for the
Carl D. Perkins Career and Technical Education Act (Perkins V) Basic
State Grant program, administered by U.S. Department of Education's
Office of Career, Technical, and Adult Education, to $2.5 billion in
the Fiscal Year (FY) 2022 Labor, Health and Human Services, Education,
and Related Agencies appropriations bill. It is vital that Congress
continues to build upon the recent increases to Perkins V in order to
fully support the implementation of the law and the over 11 million
learners it serves across the nation.\1\
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\1\ Perkins Collaborative Resource Network, State Profiles.
Retrieved from https://cte.ed.gov/profiles/national-summary.
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In the Administration's recent budget proposal, the FY 2022
discretionary request proposes only a disappointing 1.5%, or $20
million, increase for the Perkins V Basic State Grant. This is
inadequate given the growing need for skilled workers facing employers
and learner demand for CTE. The additional $1 billion annually for
middle and high school career pathways included in the President's
budget request but through the American Jobs Plan would actually have a
greater impact if this increase was authorized and appropriated through
the Basic State Grant, and thus is included in our request.
CTE at the secondary and postsecondary levels is an integral part
of achieving an equitable and efficient economic recovery. COVID-19
(the coronavirus) has affected the most foundational aspects of our
society. With millions of Americans unemployed, or underemployed, and
some industry sectors shuttered or undergoing rapid transformation,
Black and Latinx workers, workers with a high school education or less
and female workers have been disproportionately impacted. Now, more
than ever, CTE is vital to our nation's learners, employers and
economic recovery. Consider:
--The unemployment rate reached 14.8 percent in April 2020, the
highest unemployment rate since data collection started in
1948. As of May 2021 unemployment remained higher than it had
been in February 2020, before the pandemic came to the
forefront (5.8 percent compared to 3.5 percent).\2\
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\2\ Congressional Research Service, Unemployment Rates During the
COVID-19 Pandemic, June 2021. Retrieved from https://fas.org/sgp/crs/
misc/R46554.pdf.
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--The unemployment rate for teenagers aged 16-19 hit 31.9 percent in
April 2020, the highest it has even been in over 70 years. The
only other time the unemployment rate for this population
reached over 25 percent was during the Great Recession.\3\
---------------------------------------------------------------------------
\3\ U.S. Department of Labor, Bureau of Labor Statistics. Retrieved
from https://www.bls.gov/opub/ted/2020/unemployment-rate-rises-to-
record-high-14-point-7-percent-in-april-2020.htm.
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--As of May 2021, 7.9 million workers reported that they were not
able to find a job because their original employer either
closed or was not hiring because of the pandemic.\4\
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\4\ U.S. Department of Labor, Bureau of Labor Statistics, The
Employment Situation--May 2021, June 2021. Retrieved from https://
www.bls.gov/news.release/pdf/empsit.pdf.
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--The unemployment rates are also much worse for non-White young
adults--35.5 percent and 31.1 percent for Black and Latino
teenagers respectively, compared to 29 percent for White
teenagers.\5\
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\5\ U.S Department of Labor, Bureau of Labor Statistics, Labor
Force Statistics from the Current Population Survey. Retrieved from
https://www.bls.gov/web/empsit/cpsee_e16.htm, based on quarterly
averages.
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For those individuals just at the beginning of their careers,
losing opportunities to gain experience and a foothold in the labor
market can have major, long-term impacts. For example, the millennial
generation, who entered the workforce during the height of the Great
Recession, is estimated to have relatively low levels of home
ownership, net worth and real income compared to previous
generations.\6\
---------------------------------------------------------------------------
\6\ Federal Reserve Bank of St. Louis, The Demographics of Wealth,
How Education, Race and Birth Year Shape Financial Outcomes, 2018.
Retrieved from https://www.stlouisfed.org/ /media/files/pdfs/hfs/
essays/hfs_essay_2_2018.pdf?la=en.
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Unemployment trends during the pandemic have shown that upskilling
and reskilling needs have already increased, and we can expect that
will continue. CTE programs are instrumental in delivering high-quality
education programs aligned with in-demand careers. It is projected that
some--but not all--of the jobs lost during the pandemic will come back
in one form or another. One study estimates approximately 60 percent of
job loss will be temporary, while other studies predict about a quarter
of job losses will be permanent. What is not in question is that the
economy will look different on the other side of the recovery, with
marginalized communities the most likely to be impacted, given Latinx
Americans have been the most likely to have hours or shifts reduced and
Black Americans have been the most likely to have been laid off during
this crisis.\7\
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\7\ https://www.stradaeducation.org/wp-content/uploads/2020/04/
Public-Viewpoint-Report-Week-4.pdf.
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CTE serves a critical role in supporting learners in their
reskilling or upskilling as they look to either re-enter the economy or
grow into new opportunities. Looking at data from the last recession,
the vast majority of new and replacement jobs went to individuals with
more than a high school diploma, including 3.1 million jobs that went
to those with associate degree or postsecondary certificates. There is
growing data that suggest that those who lost their jobs due to the
coronavirus will pursue CTE-focused programs and degrees. About a third
of adults report that, if they lose their jobs, they would need more
education to replace them. Consider:
--A third of adults report they would potentially change careers.
--Two-thirds of adults interested in enrolling in postsecondary
education and training in the next six months would do so to
upskill or reskill.
--A majority of American workers say they prefer non-degree and
skill-based education and training programs in today's economy.
This all aligns with outcomes from the last recession, with over 50
percent of displaced workers changing industries when they re-entered
the workforce.\8\
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\8\ The White House, Addressing America's Reskilling Challenge,
2018. Retrieved from https://www.whitehouse.gov/wp-content/uploads/
2018/07/Addressing-Americas-Reskilling-Challenge.pdf.
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Just as all education programs have been hit hard by the pandemic,
so have CTE programs. This has been exacerbated by the lack of CTE-
designated funding in stimulus bills. What sets CTE apart from other
educational pathways is its focus on real-world skills and applied
learning. High-quality CTE programs provide opportunities for direct
engagement between industry and learners and instructors, often include
work-based learning experiences, and enable learners to earn
credentials of value. Yet what sets CTE apart is also what has
presented unique challenges during the coronavirus era. CTE programs
are facing many of the same dire needs as the entire education system,
particularly those related to broadband and technology access, digital
curriculum, and teacher professional development. However, many needs
in CTE are exacerbated by the applied and lab-based nature of many
courses, the need for learners to meet certification requirements, and
the benefits of work-based learning and other experiential programs.
CTE programs stand ready to provide employers a talent pipeline, and
prepare students for careers in high-skill, high-wage, or in-demand
industry sectors and occupations, but need additional support. Jobs
that require more than a high school diploma but less than a
baccalaureate degree were growing before the pandemic, and will
continue to do so now. Further, automation coupled with the
unemployment rate requires nimble, proactive, and responsive CTE and
workforce programs that provide specific technical as well as
transferable skills. As jobseekers and employers have looked to recover
from the economic impacts of the pandemic, additional funding will
ensure that the CTE system is primed to support their needs.
Despite this, no stimulus package during the pandemic has included
CTE-designated funding. Although Perkins V has been named as an
authorized use of some of the funding under the Education Stabilization
Fund in each package, there is no guarantee that money will be
allocated to CTE programs.
High-quality CTE programs are delivering real results. Across the
country, CTE programs are preparing learners for promising career paths
and giving employers and our economy a competitive edge. CTE programs
provide unique opportunities for learners to engage with employers and
participate in internships, apprenticeships and other meaningful on-
the-job experiences. In addition, these programs produce strong
outcomes for the learners they serve. The average high school
graduation rate for students concentrating in CTE is 95 percent,
compared to a national adjusted cohort graduation rate of 85
percent.\9\ Additionally, students involved in CTE are far less likely
to drop out of high school than other students, a difference estimated
to save the economy $168 billion each year.\10\ Furthermore, those
students are highly likely to continue their education-91 percent of
high school graduates who earned two to three CTE credits enrolled in
college.\11\
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\9\ Perkins Collaborative Resource Network, Perkins Data Explorer,
customized Consolidated Annual Report data. https://perkins.ed.gov/
pims/DataExplorer; U.S. Department of Education, Office of Elementary
Secondary Education, Consolidated State Performance Report, 2010-11
through 2016-17.
\10\ Kotamraju, P. Measuring the return on investment for CTE.
Techniques: 28-31, 2011. Retrieved from https://files.eric.ed.gov/
fulltext/EJ943149.pdf.
\11\ U.S. Department of Education, National Center for Education
Statistics, Data Point: Career and Technical Education Coursetaking and
Postsecondary Enrollment and Attainment: High School Classes of 1992
and 2004, 2016. Retrieved from https://nces.ed.gov/pubs2016/
2016109.pdf.
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The outcomes for adult learners are also significant: 84 percent of
adults concentrating in CTE programs either continued their education
or were employed within six months of completing their program.\12\ In
fact, 90 percent of Americans agree that apprenticeships and skills
training programs prepare individuals for a good standard of
living.\13\
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\12\ Includes only states that report data on adult CTE learners to
the U.S. Department of Education. Perkins Collaborative Resource
Network, Perkins Data Explorer, customized Consolidated Annual Report
data. Retrieved from https://perkins.ed.gov/pims/DataExplorer/
Performance.
\13\ New America, Varying Degrees 2018: Executive Summary.
Retrieved from https://www.newamerica.org/education-policy/reports/
varying-degrees-2018/executive-summary/.
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Expanding funding for CTE programs will create a brighter future
for communities--leading to more career options for learners, better
results for employers, and increased growth for our economy. Investing
in CTE programs provides substantial benefits for not just the students
enrolled, but for states and communities across the country. Every
dollar spent on secondary CTE students in Washington state leads to $26
in lifetime earnings and employee benefits,\14\ while individuals who
receive a certificate or degree from California Community Colleges
almost double their earnings within three years.\15\ In Wisconsin,
taxpayers receive $12.20 in return for every dollar invested in the
technical college system.\16\ Oklahoma's economy reaps a net benefit of
$3.5 billion annually from graduates of the CareerTech System.\17\ If
we are serious about providing learners with the real-world skills,
hands-on opportunities and real options for college and rewarding
careers that come with CTE and making progress toward closing the
skills gap, then there is no better time than now to invest $2.5
billion in Perkins CTE State Grants.
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\14\ Workforce Training and Education Coordinating Board, Workforce
Training Results 2020. Retrieved from https://www.wtb.wa.gov/wp-
content/uploads/2020/01/2020-Dashboard.pdf.
\15\ Foundation for California Community Colleges, California
Community Colleges, n.d. Retrieved from https://foundationccc.org/
Portals/0/Documents/NewsRoom/FactSheets/ccc-facts-figures.pdf.
\16\ Wisconsin Technical College System, The Technical College
Effect, 2016. Retrieved from https://www.wistechcolleges.org/sites/
default/files/POSTER8.5x11-2016update2_0.pdf.
\17\ Snead, M. C., The Economic Contribution of CareerTech to the
Oklahoma Economy: Cost-Benefit Analysis of Career Majors (FY11), 2013.
Retrieved from https://www.okcareertech.org/about/costbenefit-analysis-
of-career-majors/cost-benefit-analysis-of-career-majorsfy-11-pdf.
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CTE programs are also preparing individuals with the skills that
employers seek. A 2020 survey found that employers believe CTE is good
for business, the economy, and public education, and the majority of
those surveyed reported that those from a CTE program are better
prepared with workplace, technical and real-world skills. Employers who
recruit from CTE programs are also more likely to report industry
growth. CTE programs have long provided unique opportunities for
learners to engage with employers and participate in internships,
apprenticeships, and other meaningful on-the-job experiences. Now more
than ever, CTE serves a critical role in supporting learners in their
reskilling or upskilling as they look to either re-enter the economy or
grow into new opportunities.
CTE programs prepare students for careers in in-demand fields and
provide an affordable pathway to both a family-sustaining career and
financial independence. Health care occupations, many of which require
an associate degree or industry credential, are projected to grow 14
percent by 2028-adding almost 2 million new jobs.\18\ Half of all STEM
occupations, which offer students high-skilled, high-wage career
opportunities, require less than a bachelor's degree.\19\ There are
currently about 30 million ``good jobs''-jobs that pay a median income
of $55,000 or more and require education below a bachelor's degree.\20\
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\18\ U.S. Department of Labor, Bureau of Labor Statistics,
Occupational Outlook Handbook, Healthcare Occupations. Retrieved from
https://www.bls.gov/ooh/healthcare/home.htm.
\19\ Rothwell, J. The Hidden STEM Economy, Brookings Institution,
2013. Retrieved from https://www.brookings.edu/research/the-hidden-
stem-economy/.
\20\ Georgetown University Center on Education and the Workforce,
Good Jobs that Pay Without a BA, 2017. Retrieved from https://
goodjobsdata.org/wp-content/uploads/Good-Jobs-wo-BA-final.pdf.
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Additionally, the demand for workforce credentials is growing. The
number of individuals earning certificates or associate degrees in CTE
fields, such as manufacturing, health care, and STEM, rose 71 percent
from 2002 to 2012.\21\ Students can pursue these valuable credentials
at community and technical colleges for a fraction of the cost of
tuition at other institutions: $3,730, on average for the 2019-2020
academic year.\22\ Highly-skilled workers deliver direct benefits to
American employers through enhanced productivity and innovation;
however, the increased demands on the workforce pipeline are a
persistent barrier to economic growth. A projected three million
workers are needed to fill infrastructure jobs in the next few years,
including careers in construction, transportation and
telecommunications.\23\ Meanwhile, 89 percent of executives agree there
is a talent shortage in the U.S. manufacturing sector, 5 percent higher
than 2015 results.\24\ These industries still need talent, even in the
current economic climate.
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\21\ U.S. Department of Education, Office of Planning, Evaluation
and Policy Development, Policy and Program Studies Service, National
Assessment of Career and Technical Education: Final Report to Congress,
2014. Retrieved from https://www2.ed.gov/rschstat/eval/sectech/nacte/
career-technical-education/final-report.pdf.
\22\ College Board, Average published charges, 2018-19 and 2019-20.
Retrieved from https://research.collegeboard.org/trends/college-
pricing/figures-tables/average-published-charges-2018-19-and-2019-20.
\23\ Kane, J. W., and Tomer, A. Infrastructure skills: Knowledge,
tools, and training to increase opportunity, Brookings Institution,
2016. Retrieved from https://www.brookings.edu/research/infrastructure-
skills-knowledge-tools-and-training-to-increase-opportunity/.
\24\ Deloitte and the Manufacturing Institute, Skills Gap and the
Future of Work Study, 2018. Retrieved from http://
www.themanufacturinginstitute.org/ /media/E323C4D8F75A470E8C96D7
A07F0A14FB/DI_2018_Deloitte_MFI_skills_gap_FoW_study.pdf; Deloitte and
the Manufacturing Institute, The skills gap in U.S. manufacturing 2015
and beyond, 2015. Retrieved from http://
www.themanufacturinginstitute.org/ /media/
827DBC76533942679A15EF7067A704CD.ashx.
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Funding Perkins V at adequate levels will ensure that educators can
equip students with the skills they will need for in-demand fields.
This will become increasingly pressing as the country continues to
recover from the current health pandemic and economic crisis. Already,
healthcare jobs are projected to have the largest increase of any
occupational sector.\25\ Filling these and other positions created, as
well as ensuring that each individual is able to access the training
needed for employment, is critical.
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\25\ U.S. Department of Labor, Bureau of Labor Statistics,
Occupational Outlook Handbook, Healthcare Occupations. Retrieved from
https://www.bls.gov/ooh/healthcare/home.htm.
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CTE programs can serve even more learners and employers--but only
if they receive more resources. According to The Bureau of Labor
Statistics Job Openings and Labor Turnover Survey (JOLTS) Highlights
for May 2021, the ratio of unemployed workers to job openings is 1.2,
meaning that for 9.8 million unemployed workers there are only 9.1
million jobs available.\26\ As more jobs lost during the pandemic
become permanent, CTE remains a critical component to the workforce
pipeline for key industries that are needed to sustain a long-term
economic recovery, such as healthcare, STEM, manufacturing,
construction and transportation distribution and logistics. But,
learner demand for CTE programs, especially programs in in-demand
sectors is greater than supply. With current and anticipated demand
growing, more resources are needed to build, expand and support high-
quality CTE programs. It is vital that Congress continues to build upon
the recent increases to Perkins V to ensure we have the talent pipeline
needed to fully recover from the jobs crisis caused by the pandemic.
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\26\ U.S. Department of Labor, Bureau of Labor Statistics, Job
Openings and Labor Turnover Survey (JOLTS) Highlights; January 2020.
Retrieved from https://www.bls.gov/web/jolts/jlt_labstatgraphs.pdf.
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And there's widespread support for CTE: 94 percent of parents
approve of expanding access to CTE.\27\ However, a survey of school
districts offering CTE found that the top barrier to offering CTE in
high school was a lack of funding or the high cost of the programs.\28\
As the chart below demonstrates, between FY2004 and FY2020, funding for
CTE State Grants declined by over $77 million dollars, the equivalent
of $427 million inflation-adjusted dollars (i.e., 28 percent in
inflation-adjusted dollars).
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\27\ Hart Research Associates, Public School Parents on the Value
of Public Education: Findings from a National Survey of Public School
parents conducted for the AFT, September 2017. Retrieved from https://
www.aft.org/sites/default/files/parentpoll2017_memo.pdf.
\28\ U.S. Department of Education, National Center for Education
Statistics, Career and Technical Education Programs in Public School
Districts: 2016-17. Retrieved from https://nces.ed.gov/pubs2018/
2018028.pdf.
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Taking a longer view, before FY18, the investment in CTE State
Grants had been relatively flat since 1991 without being tied to
inflation, and the program's buying power had fallen by approximately
$933 million in inflation-adjusted dollars--a 45 percent reduction over
a quarter century.\29\ Congress recognized the need to begin to reverse
this trend and from FY18 to FY21 provided an additional $217 million
for CTE State Grants, bringing the total investment to $1.342 billion.
While the past four budgets represented initial down payments to meet
increased need, a significant, robust investment in CTE programs is
still imperative to account for persistent underfunding, the lack of
inflation-adjusted increases, and most importantly, the overwhelming
growth in demand for these programs from both learners and the American
economy. Congress should build on the momentum from recent years and
continue to strengthen the investment in CTE State Grants in FY2022.
And, Americans agree: 93 percent of voters support increasing the
investment in skills training.\30\
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\29\ U.S. Bureau of Labor Statistics, CPI Inflation Calculator.
Retrieved from https://data.bls.gov/cgi-bin/cpicalc.pl.
\30\ ALG Research, Poll Finds Overwhelming Support for More Funding
for Skills Training, 2019. Retrieved from https://
www.nationalskillscoalition.org/news/press-releases/body/Poll-Finds-
Overwhelming-Support-for-More-Funding-for-Skills-Training.pdf.
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Now more than ever, individuals need access to upskilling and
reskilling opportunities to be part of the evolving workforce, and CTE
programs will be adapting, as always, to the needs of business and
industry in the current economy. CTE is both a proactive and responsive
strategy for attending to the economic downturn--CTE programs prepare
learners for lifelong success while also offering targeted skilled
training for others. We applaud the commitment to growing our
investment in Perkins V, and we urge the subcommittee to make CTE a top
priority in the FY 2022 Labor, Health and Human Services, Education,
and Related Agencies appropriations bill. Now is not the time to back
away from our commitment to advancing high-quality CTE, but rather the
time to double down and ensure CTE programs are available for every
learner who seeks to better their own lives and opportunities
Thank you for your thoughtful consideration of our request. For
more information or if you wish to discuss our request, please contact
ACTE's Government Relations Manager Michael Matthews
([email protected]) or Advance CTE's Senior Associate for
Federal Policy Associate Meredith Hills ([email protected]).
______
Prepared Statement of the Association for Clinical Oncology
The Association for Clinical Oncology (ASCO), the world's leading
professional organization representing nearly 45,000 physicians and
other professionals who treat people with cancer, thanks this
subcommittee for its long-standing commitment to support federally
funded research at the National Institute of Health (NIH) and National
Cancer Institute (NCI). ASCO is extremely grateful for the $1.25
billion increase for the NIH in fiscal year (FY) 2021. This strong
commitment to scientific discovery will help the research community
continue current momentum and sustain our nation's position as the
world leader in biomedical research. ASCO appreciates this opportunity
to provide the following recommendations for FY2022 funding to build on
our nation's investment in biomedical research:
--National Institutes of Health (NIH): $46.111 billion
--National Cancer Institute (NCI): $7.609 billion
-- Beau Biden Cancer Moonshot Initiative: $194 million
--Centers for Disease Control and Prevention's (CDC) Division of
Cancer Prevention and Control (DCPC): $559 million
--Cancer Registries Program: $70 million
the nih: a good investment
In FY2020, the NIH provided over $34 billion in extramural research
to scientists in all 50 states and the District of Columbia.\1\ NIH
research funding also supported more than 536,000 jobs and generated
over $91 billion in economic activity last year.\2\
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\1\ National Institutes of Health; https://www.nih.gov/about-nih/
what-we-do/impact-nih-research.
\2\ United for Medical Research; https://
www.unitedformedicalresearch.org/wp-content/uploads/2021/03/NIHs-Role-
in-Sustaining-the-U.S.-Economy-FINAL-3.23.21.pdf.
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The importance of federally funded biomedical research has been on
display over the last year as scientists from all corners of the
country worked to quickly develop effective COVID-19 vaccines.
Researchers working towards a vaccine were not starting from scratch;
years of federally funded research progress led to the discovery and
identification of practical uses for messenger RNA, or mRNA, as used in
the Pfizer and Moderna vaccines. Prior to COVID-19 cancer researchers
were using mRNA to trigger the immune system to target specific cancer
cells. Building on previous scientific advancements, coupled with
collaboration across federal agencies, academic institutions, and the
private sector, unprecedented flexibility, and reduction in regulatory
red tape, the resulting vaccines came to market at a record pace. This
remarkable achievement--a result of years of research and scientific
discovery--is a testament to the need for continued investment.
Despite recent funding increases, the COVID-19 pandemic has
resulted in stagnant research progress and low clinical trial accrual
rates, stifling the progress of our biomedical research enterprise and
weakening our clinical trials networks. The funding levels we are
requesting for FY2022 would aid in recovery from these setbacks and
allow meaningful growth above biomedical inflation for the first time
in over a decade. They would also allow the extraordinary progress seen
pre-pandemic to continue. Failure to sustain investment in research
places health outcomes and the scientific leadership and economic
growth of the country at risk.
the nci: the need for a renewed commitment
This year marks the 50th anniversary of the passage of the National
Cancer Act of 1971, which established the NCI in its current form. Over
the last 30 years alone, the cancer death rate has fallen 31%. This
includes a 2.4% decline from 2017 to 2018--a record for the largest
one-year drop in the cancer death rate. However, even during a global
pandemic, cancer remains the second most common cause of death in the
United States. In 2021, almost 1.9 million new cancer cases will be
diagnosed, and more than 600,000 people will die from cancer.\3\
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\3\ American Cancer Society; https://www.cancer.org/content/dam/
cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-
and-figures/2021/cancer-facts-and-figures-2021.pdf.
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The time is ripe for a renewed commitment for robust NCI funding.
ASCO is grateful for funding provided to the Beau Biden Cancer Moonshot
Initiative and its focus on modernizing clinical trials, establishing a
direct patient engagement network, developing a national cancer data
ecosystem, continuing advances in precision oncology, and developing
effective immunotherapies for a broader array of cancers. However,
funding for the Initiative peaked FY2019, and dropped to $195 million
in FY2021; FY2023 will mark the last year of authorized Moonshot
funding. ASCO urges Congress to bolster NCI funding in anticipation of
the end of the Cancer Moonshot Initiative.
The NCI is the largest funder of cancer research in the world, with
most of its funding directly supporting research at NCI and at cancer
centers, hospitals, community clinics, and universities across the
country. While the NCI has received modest funding increases over the
last few years, funding has not kept up with the growth of research
grant applications as compared to other NIH Institutes or Centers. In
fact, over the last five years R01 grant applications submitted to the
NCI rose by 50%, while funding only grew by 20%. This means NCI is
funding a smaller proportion of grant applications compared to previous
years. Only 10% of viable applications received funding in 2020
compared to 28% in 1997. Even after accounting for Cancer Moonshot
funding, NCI's budget has not kept up with scientific opportunity. ASCO
supports the NCI's 15 by 25 initiative, in which the Institute aims to
fund 15% of grant applications by 2025. Unfortunately, the President's
FY2022 budget proposal of $6.733 billion for the NCI would not allow
for an increase in funded applications for 2022. ASCO's request of
$7.609 billion for FY2022 would allow NCI to fund 12% of grants
submitted, a modest increase, but a step closer to their own goal.\4\
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\4\ National Cancer Institute; https://www.cancer.gov/research/
annual-plan/2022-annual-plan-budget-proposal-aag.pdf.
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bringing the research to the patient
NIH-funded translational research and clinical trials have
significantly improved the standard of care in many diseases. Clinical
trials and translational research yield insight critical to the
development of targeted therapies, which identify patients most likely
to benefit from treatments and help patients who will not benefit avoid
the cost and pain of treatment unlikely to help them. This is where
science becomes practice-changing for patients in America.
ASCO has developed the Targeted Agent and Profiling Utilization
Registry (TAPUR(tm)) Study, which provides access to targeted therapies
for patients aged twelve and older and who have been identified as
candidates for benefitting from those treatments because of a promising
tumor biomarker target identified in their cancer. TAPUR evaluates use
of these molecularly targeted anti-cancer drugs and collects data on
clinical outcomes. As of May 2021, there are over 2,130 participants
enrolled in the TAPUR Study at 128 sites in 24 states. Without federal
investment spurring the pipeline of new cancer treatments, studies such
as TAPUR would not be possible.
To maintain access to research for cancer patients, ASCO urges a
substantial increase in funding for the National Clinical Trials
Network (NCTN) and NCI Community Oncology Research Program (NCORP).
Just last year, the NCI awarded 53 grants to researchers at 46 NCORP
sites, which have assembled more than 1,000 affiliates across the
country to conduct research. The NCORP network now covers 44 states and
the District of Columbia.\5\ An increase in NCI's budget would enable
the Institute to maintain or increase the number of accruals to trials
and cover the cost of conducting research.
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\5\ National Cancer Institute; https://ncorp.cancer.gov/news/2019-
08-19.html.
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cancer registries & clinical trials: harnessing data & reducing
disparities
We have seen tremendous progress in cancer research. Even so, with
more targeted and patient-specific therapies in development, certain
populations are still missing out on potentially life-threatening
treatment options. ASCO was encouraged to see the CLINICAL TREATMENT
Act become law at the end of 2020. This legislation will require
Medicaid to cover routine care costs for clinical trials for patients
with life-threatening conditions. A step forward, but barriers remain;
diversity and generalizability of clinical trials is crucial for making
trial results applicable more broadly and to ensure positive clinical
outcomes for all patients. We hope to continue our work with Congress,
NCI, and the Centers for Medicare and Medicaid Services (CMS) to
improve access to clinical trials for underrepresented patient
populations.
As a compliment to inclusive trials, cancer providers and
researchers also need accessible data to understand cancer at a broader
level. This data can prove especially crucial for rare and pediatric
cancers, where trials are limited due to smaller patient populations.
To that end, ASCO joins the cancer community in requesting $559 million
for the CDC's Division of Cancer Prevention and Control (DCPC), and $70
million for the CDC's Cancer Registries Program. Cancer registries are
a critical tool for providers and researchers, providing cancer
surveillance, identifying trends amongst different patient cohorts,
illustrating the impact of early detection, and showing the impact of
treatment advances on cancer outcomes. Registries allow providers to
collect data in real time and improve cancer research, public health
interventions and treatment protocols. While we work towards greater
trial inclusion, registries help ensure we have data from
underrepresented patient cohorts such as racial and ethnic minorities,
women, children, and rural populations.
working towards cures: a new approach
Modern cancer research delivers new treatments to patients faster
than ever, thanks to continuing innovation in research and regulatory
infrastructure. The continued investment Congress has made in cancer
research helps make progress possible. ASCO is committed to partnering
with Congress and the Administration to spur innovation and expediently
get treatments to patients.
As Congress and the Administration evaluate ways to improve our
national biomedical research enterprise through such efforts as the
proposed Advanced Research Projects Agency-Health (ARPA-H), we urge
lawmakers to leverage collaboration between the private market,
biotech, health care companies, academic institutions, and government
and regulatory agencies. Fostering public-private partnerships and
standardization to accelerate discovery to clinically impactful
products that help patients is vital. Additionally, any efforts to
establish a new agency or reform the biomedical research enterprise and
health innovation, should ensure sustained and dedicated funding to
achieve impactful translational research with demonstration of patient
benefit. It should not impact the current or future resources of
existing research enterprises.
Any new agency should be transparent about its selection criteria
and decision-making process for its broad strategic goals and selection
of individual research projects, including clear metrics to ensure the
funds are being used to advance public health meeting established
deliverables. Furthermore, innovation should come from peer-reviewed
science that provides evidence-based decision making for care, and the
findings should be published in peer-reviewed publications. Finally, as
previously discussed, all patients should have access to the clinical
trials and the resulting treatments conducted with investment by the
agency; insurance coverage and cost should not be a barrier to clinical
trial participation and equitable care; and should implement strategies
to encourage decentralization of trials and ensure diversity and equity
in research.
mitigating the effects of covid-19 and continuing the work towards
cures
As with nearly every sector of society, individuals in the research
community have faced loss of employment, lab closures, and loss of
momentum in pre-pandemic research. Younger investigators and support
staff have been especially vulnerable during the last year. Our
clinical trials network has also been impacted; one study showed that
clinical trial enrollment in May 2020 was 73% lower than accrual in May
2019.\6\ Another study found the COVID-19 pandemic was associated with
a 60% decrease in the number of launches of oncology clinical trials of
drugs and biologic therapies.\7\ In May 2021, NCI Director Ned
Sharpless, M.D. speculated that clinical trial accrual was still just
50% of what it had been pre-pandemic.
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\6\ U.S. National Institutes of Health's National Library of
Medicine; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7538012/#ref
\5\.
\7\ The Journal of the American Medical Association https://
jamanetwork.com/journals/jamanetworkopen/fullarticle/2775637.
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To regain the momentum over the last few years, lawmakers and
researchers will need to work together to mitigate COVID-19 related
disruptions to research and restore momentum across the nation's
medical research network. Therefore, I urge you to prioritize the
important role NIH and NCI play in medical innovation and economic
growth by protecting and strengthening federally funded research in
FY2022.
ASCO again thanks the subcommittee for its continued support of
cancer patients in the U.S. through funding for the NIH, NCI, and CDC.
We look forward to working with all members of the subcommittee on an
FY2022 budget that continues to advance U.S. cancer research. Please
contact Kristin Stuart at [email protected] with any questions.
[This statement was submitted by Howard Burris, MD, FASCO, Chair of
the Board, Association for Clinical Oncology.]
______
Prepared Statement of the Association for Psychological Science
aps recommendations for fiscal year 2021 appropriations
_______________________________________________________________________
--APS strongly supports the Administration's request for $51 billion
for NIH in FY 2022. We are eager to see the details of the
President's request. We appreciate the Administration's
commitment to meaningful growth in the base budget and
expanding NIH's capacity to support promising research in all
scientific fields that contribute to improved health.
--APS is pleased that an NIH working group has been established to
review how to integrate and realize the benefits of overall
health from behavioral research at NIH, but we request Congress
include report language urging that this review also address
the necessary funding, authority, and organizational changes
needed for the Office of Behavioral and Social Sciences
Research (OBSSR) to better meet its mission. OBSSR has the
mission to enhance NIH's behavioral science research enterprise
across all institutes and centers. Its direct authorities to
achieve its mission, however, are limited. OBSSR does not
report directly to the NIH Director and has no grantmaking
authority. Importantly, with a small budget of less than 1/1000
of NIH's overall budget, it has limited capacity to leverage
institutes' research priorities. APS urges that these
limitations be addressed in the NIH review.
--Finally, APS asks the Committee to favorably consider the requests
of the Psychological Clinical Science Accreditation System
(PCSAS) to urge the modification of HRSA and National Health
Service Corps regulations to permit the graduates of PCSAS-
accredited schools to be eligible for employment in these
programs. APS believes that the strong emphasis on science in
PCSAS accreditation offers promise of improved prevention and
treatment interventions which will strengthen HRSA and the
National Health Service Corps programs.
_______________________________________________________________________
statement of aps executive director
Chairwoman Murray, Ranking Member Blunt, and Members of the
Subcommittee, thank you for the opportunity to provide testimony as you
consider funding priorities for Fiscal Year (FY) 2022. I am Robert
Gropp, Executive Director of the Association for Psychological Science
(APS). APS is a nonprofit scientific organization dedicated to
advancing the science of psychology for the benefit of science and
society. APS recognizes and appreciates the Subcommittee's efforts to
strengthen public health research in the United States.
funding for the national institutes of health and policy issues
As previously noted, APS recommends an FY 2022 funding level of $51
billion for NIH, which would enable real growth over health research
inflation as an important step to ensuring stability in the Nation's
research capacity over the long term. In addition to funding
priorities, APS is concerned about several policy issues at HHS.
1. Inclusion of Psychologists in the Pandemic Response: Nearly
600,000 Americans have died from COVID-19. This is a tragedy that is
based in human behavior, both in the human response necessary to stop
the spread of the disease as well as the disproportionate impact of the
disease on health disparity and racial and ethnic minority populations.
Research from psychological science must be one of the inputs informing
an effective public health emergency response. Psychology research
teaches us how to encourage individuals to practice safe behaviors and
receive vaccines, for example. But psychological scientists investigate
fundamental science questions, too. For instance, improved scientific
understanding of risk assessment, social motivations, and interpersonal
relationships can powerfully influence the spread of infectious
diseases. Psychological science helps us address consequences of social
distancing such as loneliness and emerging threats to mental health.
Researchers in our field have proven essential to improving our
understanding and addressing COVID-19's impact. APS urges that the
following report language be included in the FY 2022 Labor-HHS Report:
Behavioral Science and the COVID-19 National Strategy.--The
Committee applauds the Administration's robust National
Strategy for the COVID-19 Response and Pandemic Preparedness
and appreciates that the strategy reflects the best advice of
scientists and public health experts. However, even with
effective and safe vaccinations, we must continue and expand
mask-wearing, testing, and social distancing; all citizens,
organizations, and communities must rally together in that
common purpose. As our success in these areas depends on our
scientific understanding of human behavior, the Committee urges
that the Department include psychological scientists at every
level of the Department's response to COVID-19 and future
public health emergencies to best and most effectively meet
these common goals.
2. Behavioral Science at NIH: The NIH mission is to ``seek
fundamental knowledge about the nature and behavior of living systems
and the application of that knowledge to enhance health, lengthen life,
and reduce illness and disability.'' APS is concerned by the continued
low level of funding support for behavioral science research and
training at NIH despite the central importance of this research to all
dimensions of human health. APS is pleased that the NIH Council of
Councils created a new Behavioral Sciences Working Group on Integration
and Realization of the Benefits to Health from Behavioral Research at
NIH to complete an assessment providing recommendations on how NIH-
funded behavioral research can be better integrated with the NIH
research programs to improve health. There is concern, however, that
this working group may not look beyond current structures and
practices. We request that the following report language be included in
the FY 2022 Labor-HHS Report to direct NIH to ensure that appropriate
OBSSR funding levels, authority, and organizational structure be
included in this review.
Enhancements for the Office of Behavioral and Social Sciences
Research.--The Committee notes that the Office of Behavioral
and Social Sciences Research (OBSSR) has the mission to enhance
NIH's behavioral science research enterprise across all
institutes and centers. As multiple Surgeons General and the
National Academy of Medicine have declared that most health
problems facing the nation have significant behavioral
components, the Committee strongly supports the continued
strengthening of the behavioral science enterprise at NIH and
urges OBSSR funding and authorities be increased to accomplish
this mission. In this regard, the Committee is pleased that an
NIH working group has been established to review how better to
integrate and realize the benefits of overall health from
behavioral research at NIH, and directs that appropriate OBSSR
funding levels, authority, and organizational structure be
included in this review.
updating hrsa and national health service regulations
APS requests the Committee favorably consider the requests of the
Psychological Clinical Science Accreditation System (PCSAS) to urge the
modification of HRSA and National Health Service Corps regulations to
permit the graduates of PCSAS-accredited schools to be eligible for
employment in these programs. The strong emphasis on science in PCSAS
accreditation offers promise of improved prevention and treatment
interventions that will strengthen HRSA and the National Health Service
Corps.
PCSAS was recognized by the Council for Higher Education
Accreditation (CHEA) in 2012 and now accredits 45 of the Nation's
doctoral clinical science programs. CHEA is the largest higher
education membership organization in the United States. It is a
national body formed by 3,000 universities which reviews and screens
applications from organizations to serve as accrediting bodies for the
professions. CHEA is widely recognized as a primary national voice for
accreditation and quality assurance. After a thorough review, CHEA
approved the Psychological Clinical Science Accreditation System
(PCSAS) in September 2012 to accredit schools of clinical psychology.
Prior to 2012, the American Psychological Association (APA) was the
only accrediting body for clinical psychology programs. Many agency
regulations are outdated and refer to the need for applicants for
employment to have graduated from APA accredited programs. This
historical artifact needs to be updated for HRSA and the National
Health Service Corps. Doing so will help to ensure the federal
government is able to recruit and hire top quality psychologists,
regardless of whether they are from an APA or PCSAS accredited graduate
program.
1. Updating Two HRSA Health Professions Programs Regulations is
Necessary: HRSA's two psychology education training programs, called
the Behavioral Health Workforce Education and Training Program (BHWET)
and the Graduate Psychology Education Program (GPE), support programs
that produce graduates who work in clinical psychology practice upon
completion of their program. The authorizing statute in the Public
Health Service Act at 756(a)(2) specifically says the Secretary may
make grants for the ``...training of psychology graduate students for
providing behavioral and mental health services...''; however, the
authorizing legislation limits eligibility to the graduates of APA-
accredited programs. This excludes the graduates of PCSAS-accredited
programs. FY 2021 report language is requested to open program
eligibility to the graduates of PCSAS accredited programs. The language
follows:
Health Workforce Eligibility Requirements.--The Committee is
concerned that HRSA has not complied with the language in the
Joint Explanatory Statement for Public Law 216-260 which urged
HRSA to update eligibility requirements for the BHWET program
and the GPE program to account for accreditation changes that
have occurred since the eligibility requirements were
established. The Committee notes the Council for Higher
Education Accreditation, as well as the Department of Veterans
Affairs, recognizes the Psychological Clinical Science
Accreditation System [PCSAS]. HRSA is directed to make the
necessary administrative updates to ensure that HRSA's health
workforce programs continue to have access to the best
qualified applicants, including those who graduate from PCSAS
programs.
2. Updating National Health Service Corps Regulations is Necessary:
The regulations of the National Health Service Corps also need to be
updated. While this change has been agreed to, it remains pending for
final approval. The language needed to urge this change follows:
Public Health Service Corps Eligibility Requirements.--The
Committee is concerned that the Office of the Surgeon General
has not complied with the language in the Joint Explanatory
Statement for Public Law 216-260 which encouraged the Secretary
to update accreditation and eligibility requirements for the
Public Health Service Corps to allow access to the best
qualified applicants, including those who graduate from
Psychological Clinical Science Accreditation System programs.
The Committee directs the Department to make these necessary
the necessary changes to its eligibility requirements.
summary and conclusion
We thank the Subcommittee for its ongoing commitment to supporting
scientific research that improves the human condition in the United
States and around the world. Reducing barriers to research and training
in behavioral science is warranted by the central role of behavior in
many of our most pressing health problems and by the enormous potential
of psychological science and other behavioral science disciplines to
reduce the suffering experienced by the millions of people with
behavior-based conditions. APS shares your commitment to addressing the
health needs of the Nation and appreciates the opportunity to provide
this testimony.
[This statement was submitted by Robert Gropp, Executive Director,
Association for Psychological Science.]
______
Prepared Statement of the Association for Research in Vision
and Ophthalmology
executive summary
The Association for Research in Vision and Ophthalmology (ARVO), on
behalf of the eye and vision research community, thanks Congress,
especially the House and Senate LHHS Appropriations Subcommittees, for
the strong bipartisan support for the National Institutes of Health
(NIH) funding increases from Fiscal Year (FY) 2016 through FY2021.
This past investment in NIH has improved our understanding of
fundamental life and health sciences and prepared the nation to combat
unprecedented health threats, including COVID-19. To maintain this
momentum in FY2022, ARVO strongly supports $51.95 billion in NIH
funding as proposed by President Biden, including no less than $46.1
billion for NIH's base program level budget (absent proposed funding
for the Advanced Research Projects Agency--Health [ARPA-H]), an
increase of at least $3.177 billion or 7.4%, which would allow NIH's
base budget to keep pace with the Biomedical Research and Development
Price Index (BRDPI) and allow for 5% growth. This increase will support
promising science across all Institutes and Centers (ICs), ensure
continued Innovation Account funding established through the 21st
Century Cures Act for special initiatives, and support early-stage
investigators.
Along with our partners and other scientific societies, ARVO also
urges one-time emergency funding for federal agency ``research
recovery'' investment to enable NIH to mitigate pandemic-related
disruptions without foregoing promising new science. ARVO supports the
bipartisan Research Investment to Spark the Economy (RISE) Act (H.R.
869/S. 289) which includes $10 billion for NIH.
ARVO also urges Congress to fund the NEI at $900 million, a $64.3
million or 7.7% increase over FY2021 that reflects both biomedical
inflation and growth, compared to the Administration's suggested $858.4
million funding level-a $22.83 million or 2.7% increase. Despite NEI's
total $160 million funding increases in the FY2016-2021 timeframe, its
enacted FY2021 budget of $835.7 million is just 19% greater than the
pre-sequester FY2012 funding of $702 million. Averaged over those nine
fiscal years, the 2.1% annual growth rate is still less than the
average annual biomedical inflation rate of 2.7%, thereby eroding
purchasing power. In fact, NEI's FY2021 purchasing power is less than
that of FY2012.
The NEI currently faces an increasing burden of vision impairment
and eye disease due to an aging population, the disproportionate risk/
incidence of eye disease in minority populations, and the impact on
vision from numerous chronic diseases, such as diabetes. NEI also faces
additional challenges with the COVID-19 pandemic, as both the working-
age population and students have relied almost exclusively on
electronic devices and e-learning platforms, which research has shown
correlates to increased rates of myopia, dry eye and eye strain.
Maintaining the momentum of eye and vision research is vital to
vision health and to overall health and quality of life and would
secure the U.S. as the world leader in eye and vision research and
training the next generation of eye and vision scientists.
nei-funded research saves sight and restores vision
Historical federal investment has led to landmark advances in the
prevention of vision loss as well as the restoration of vision,
including:
--Audacious Goals Initiative: The NEI has been at the forefront of
regenerative medicine with its Audacious Goals Initiative
(AGI), launched in 2013 with the goal of restoring vision. AGI-
funded consortia have developed innovative ways to image the
visual system such that researchers can now look at individual
nerve cells in the eyes of patients to learn directly whether
new treatments are successful. Another consortium has
identified biological factors that allow neurons to regenerate
in the retina, and current AGI proposals may result in clinical
trials for therapies within the next decade.
--Retinal Diseases: The NEI has been at the forefront of research
into retinal diseases. NEI-funded researchers helped to show
that the Vascular Endothelial Growth Factor (VEGF) protein
stimulates abnormal blood vessel growth that occurs in the
advanced stages of the ``wet'' form of age-related macular
degeneration (AMD) and diabetic retinopathy. Food and Drug
Administration (FDA)-approved anti-VEGF drug therapies that
slow the development of blood vessels in the eye delay vision
loss and may improve vision for patients. NEI has funded
comparison trials of anti-VEGF drugs to provide clinicians and
patients with information they need to choose the best
treatment options. With respect to the ``dry'' form of AMD,
also known as geographic atrophy and is the leading cause of
vision loss among individuals age 65+, since 2019 NEI has been
performing a first-in-human clinical trial that tests a stem
cell-based therapy from induced pluripotent stem cells (iPSC)
to treat geographic atrophy. This trial converts a patient's
own blood cells to iPS cells which are then programmed to
become retinal pigment epithelial (RPE) cells, which nurture
the photoreceptors necessary for vision and which die in
geographic atrophy. Bolstering remaining photoreceptors, the
therapy replaces dying RPE with iPSC-derived RPE.
--Genetics/Genomics: The NEI has been at the forefront of genetics/
genomics and gene therapy approaches to various eye and vision
disorders-both common and rare. The causes of AMD and glaucoma
remain elusive, although most cases are not inherited, genetics
does play a role. While NEI-funded researchers have identified
many genetic risk factors for AMD and glaucoma, further study
of these genes is helping to understand disease biology and the
promise for improved therapies. NEI-funded research has also
made discoveries of dozens of rare eye disease genes possible,
including the discovery of RPE65, which causes congenital
blindness known as Leber congenital amaurosis (LCA). As of late
2017, NEI's initial efforts led to a commercialized FDA-
approved gene therapy for this condition. These gene-based
discoveries form the basis of new therapies that treat and may
prevent the disease.
--Front-of-Eye Research: The NEI has launched an Anterior Segment
Initiative (ASI) studying clinically significant, front-of-eye
problems such as ocular pain and Dry Eye Disease (DED),
especially in terms of pain and discomfort sensations and
disruptions in the tearing process. Using multi-disciplinary
approaches, the ASI plans to elucidate relevant anterior
segment innervation pathways that contribute to normal or
abnormal functioning of the neural circuits related to the
ocular surface.
nei funding demonstrates signifigant return on investment
Optical coherence tomography (OCT) is a technology developed with
federal research funding through the NIH, which has led to significant
cost savings by helping to diagnose conditions that lead to vision loss
among patients more efficiently. In 2017, ARVO shared the story of OCT,
including the significant associated cost savings:
--$9 billion: Medicare savings from clinicians using OCT to optimize
the injection schedule of anti-VEGF drugs for patients with
wet-AMD
--$2.2 billion: Wet-AMD patient savings from reduced spending on drug
copays
--$0.4 billion: Total investment over 20 years made by NIH and NSF to
invent and develop the technology
--2,100%: Return on taxpayer investment
[http://www.ajo.com/article/S00029394(17)30419-1/fulltext]
nei research addresses increasing burden of eye disease
NEI's FY2021 enacted budget of $835.7 million is less than 0.5% of
the $177 billion annual cost (inclusive of direct and indirect costs)
of vision impairment and eye disease, which was projected in a 2014
Prevent Blindness study to grow to $317 billion--or $717 billion in
inflation-adjusted dollars--by year 2050. Of the $717 billion annual
cost of vison impairment by year 2050, 41% will be borne by the federal
government as the ``Baby Boomer'' generation ages into the Medicare
program. A 2013 Prevent Blindness study reported that direct medical
costs associated with vision disorders are the fifth highest--only less
than heart disease, cancers, emotional disorders, and pulmonary
conditions. The U.S. is spending only $2.53 per person, per year for
eye and vision research, while the cost of treating low vision and
blindness is at least $6,680 per person, per year. [http://
costofvision.preventblindness.org/]
Investing in vison health is an investment in overall health. In
summary, ARVO requests FY2022 NIH funding of at least $51.95 billion,
but urges the Subcommittee to appropriate no less that $46.1 billion
for the NIH's base program level. Further, we request NEI funding of
$900 million. ARVO also supports one-time emergency ``research
recovery'' investment to mitigate the pandemic-related disruptions
without foregoing promising new science.
The Association for Research in Vision and Ophthalmology (ARVO) is
the largest eye and vision research organization in the world. Members
include approximately 10,000 eye and vision researchers from over 75
countries.
______
Prepared Statement of the Association of American Cancer Institutes
The Association of American Cancer Institutes (AACI), representing
102 premier academic and freestanding cancer centers across the United
States and Canada, appreciates the opportunity to submit this statement
for consideration by the subcommittee. AACI submits this request for
the Department of Health and Human Services budget for the National
Institutes of Health (NIH) as the subcommittee considers Fiscal Year
(FY) 2022 funding. AACI requests a $3.177 billion increase for the NIH
for FY 2022, bringing the recommended funding level for the NIH to
$46.111 billion. This proposed level of NIH funding would ensure that
academic cancer centers conducting lifesaving research can continue to
discover and deliver new therapies for patients with cancer. AACI also
requests at least $7.609 billion in FY 2022 for the National Cancer
Institute (NCI).
Additionally, we look forward to seeing what comes of the $6.5
billion proposal for an Advanced Research Projects Agency-Health (ARPA-
H) that was laid out in President Biden's Fiscal Year 2022 (FY22)
budget. We appreciate the proposal outlining cancer as a primary
initial focus of ARPA-H. We are pleased with any expenditures that
include more funding for cancer research; however, our hope is that the
APRA-H proposal will not be diverting any funding from base funding for
the NIH or the NCI. As Congress moves into the Fiscal Year 2022 (FY22)
budget process and consideration of an infrastructure package, we
wanted to share our priorities related to the budget.
aaci cancer centers
AACI cancer centers are beacons of discovery, largely funded by the
NIH and NCI. In order to ensure continued progress, these agencies rely
on stable, predictable federal funding to invest in groundbreaking
cancer research.
Cancer centers develop and deliver state-of-the-art therapies and
provide comprehensive care, from prevention to survivorship, to
patients. These centers are at the forefront of the national effort to
eradicate cancer, yet progress in cancer research is complex and time-
intensive. The pace of discovery and translation of novel basic
research to new therapies can be accelerated if researchers are able to
count on an appropriate and predictable investment in federal cancer
funding.
covid-19 challenges
The COVID-19 pandemic has taken a significant toll on medical
research, making increased funding more critical than ever. Clinical
trials were brought to a halt and trial sites experienced challenges
with safely facilitating care for enrolled patients and freezing the
process of enrolling new patients.
As noted in last year's testimony, American Cancer Society data
show that the mortality rate from cancer in the United States has
declined 29 percent since its peak in 1991. This translates to more
than 2.9 million deaths avoided between 1991 and 2016--progress tied to
the commitment of Congress to fund the NIH and NCI.\1\ Dr. Norman E.
Sharpless, NCI director, has stated that the COVID-19 pandemic will
influence cancer mortality for at least the next decade, with an
estimated 10,000 additional breast and colorectal cancer deaths during
this time.\2\ Further, the NCI reports that an increase in overall
cancer mortality rates for the first time in almost 30 years is likely
due to the impact of COVID-19. But the pandemic has taught us important
lessons about the benefits of scientific progress to public health.
---------------------------------------------------------------------------
\1\ https://www.cancer.org/latest-news/facts-and-figures-2020.html.
\2\ https://cancerletter.com/nci-director-report/20200619_1/.
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The future of cancer research relies on robust funding to the NIH
and NCI. The broad portfolio of science supported by these agencies is
essential for improving our basic understanding of cancer and has
contributed to the health and well-being of Americans. We cannot let
the challenges of the last year slow this meaningful progress.
payline
Uncertainty surrounding research project grants (R01s) from year to
year and a decline in cancer center resources often drives promising
scientists to explore opportunities abroad or outside of the biomedical
research community. For most academic cancer centers, the majority of
NCI grant funds are used to sustain shared core resources that are
essential to basic, translational, clinical, and population cancer
research, or to provide matching dollars that allow departments to
recruit new cancer researchers to a university and support them until
they receive their first grants. It is imperative that we enable
America's scientists to master their craft.
We noted last year that in FY 2020, R01 grants for established and
new investigators are being funded to the 10th percentile, up from the
8th percentile in FY 2019. In FY 2021, the grants were funded to the
11th percentile.\3\ We request that Congress build on progress with a
FY 2022 funding increase to meet the goal of raising the NCI payline to
the 15th percentile by FY 2025. AACI supports the NCI Director's
Professional Judgment Budget Proposal for FY 2022 of $7.609 billion for
the NCI, which will increase funding to the 12th percentile.\4\
---------------------------------------------------------------------------
\3\ https://www.cancer.gov/grants-training/nci-bottom-line-blog/
2021/funding-from-congress-allows-nci-to-raise-grants-payline.
\4\ https://www.cancer.gov/research/annual-plan/budget-proposal.
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conclusion
Now is the time for Congress to invest in biomedical research--and
cancer research in particular. According to the American Cancer
Society, there will be an estimated 1.9 million new cancer cases
diagnosed in the United States in 2021.\5\ Fortunately, improvements in
early detection, cancer staging, and surgical techniques, as well as
the development of innovative therapies, have contributed to better
outcomes for patients with cancer. We join our colleagues in the
biomedical research community in recommending that the subcommittee
recognize the NIH as a national priority by enacting a final FY 2022
spending package that includes $46.111 billion for the NIH and $7.609
billion for the NCI.
---------------------------------------------------------------------------
\5\ https://www.cancer.org/research/cancer-facts-statistics/all-
cancer-facts-figures/cancer-facts-figures-2021.html.
---------------------------------------------------------------------------
A robust federal investment in NCI-Designated Cancer Centers and
academic cancer centers will allow the cancer research community to
accelerate progress against cancer, despite challenges such as the
COVID-19 pandemic.
[This statement was submitted by Jennifer W. Pegher, Executive
Director,
Association of American Cancer Institutes.]
______
Prepared Statement of the Association of American Educators Fellows
My name is Jessica Saum and I am a special education teacher at
Stagecoach Elementary School in Cabot, Arkansas. I am the current
Stagecoach Elementary School and Cabot Public School Distict's Teacher
of the year. I teach a self-contained classroom of students grades
kindergarten through fourth grade where my students spend less than 40%
of the school day out of my classroom with their typically developing
peers. This time includes lunch, recess, activity classes, and for
certain students instructional times such as phonics, social studies,
and science.
Students with diverse needs, especially those in early childhood
special education, need more time in the general education classroom
learning prosocial behaviors and having more exposure to grade level
curriculum. In order to provide this, schools need additional funding
to ensure staffing of trained paraprofessional support for students
with moderate to severe learning disabilities as well as to fund
inclusion co-taught classroom supporting those with specific learning
disabilities and deficits in specific content areas.
When learning happens in an inclusive classroom, general education
teachers and special education teachers work together and are able to
meet the needs of all students. Carl A. Cohn, EdD, the executive
director of the California Collaborative for Educational Excellence,
said, ``It's important ... to realize that special education students
are first and foremost general education students.'' This is often not
how students with special needs are treated.
Inclusive classes look different in how they are arranged and how
they operate. Some use co-teaching with a collaborative team model
having is a special education teacher in the room all day. In other
inclusive classrooms, there is a special education teacher that
``pushes in'' to the class during specific times during the day to
teach. This allows students to minimize transitions that can be very
overwhelming, and is used in place of pulling kids out of class to a
separate room. In both of these situations, teachers are available to
teach and help all students.
This type of learning is beneficial for all students, not just for
those who are receiving special education services, having both
positive short-term and long-term effects. Studies have shown that
students with special education needs who are in inclusive classes are
absent less often and develop stronger skills in reading and math.
Additionally they also more likely to have jobs and pursue education
after high school. The same research shows that their peers benefit,
too. The typically developing students are more comfortable with and
more tolerant of differences. I have seen this in my own children as
they have formed meaningful relationships with students I teach and are
advocates even at a young age and friends to exceptional learners.
Most students than ever with special needs are expected to take the
same high stakes assessments as students without special needs. Eleven
of the thirteen students in my special class setting took the same
district and state assessments as their grade level peers in the 2020-
2021 school year. They deserve the opportunity to learn alongside
typical peers, having access to the same curriculum, with the support
from special educators to navigate appropriate prosocial behaviors and
receive modifications and accommodations to ensure success.
What we must directly address is how we can spend this much-needed
federal money. It is important to determine whom it goes to when
investing more into this often overlooked population, where the needed
training comes from, and for whom is it used for. General education
teachers need additional training provided at the state level through
professional development at their district or coop, specifically on
High Leverage Practices for Inclusion to support this data proven
practice being implement in their classrooms. There needs to be
increased funding, specifically designated for districts to hire
additional paraprofessionals and special education teachers to work
with students in the general education classroom, ensuring students are
being educated in their least restrictive environment as required
through the Individuals with Disabilities Act (IDEA). Furthermore,
there needs to be an increased emphasis nationally at the collegiate
level in teacher preparation programs on educating diverse learners in
the general education setting. Teachers are not adequately prepared to
meet the needs of exceptional learners when they enter the teaching
profession and the lack of training to ensure this has led to many
students being educated in settings more restrictive than necessary.
Teachers can and will do more when supported appropriately and when
they are properly trained. I have witnessed this first hand as a
special education teacher. When my students have general education
teachers trained to support them and confident in their abilities to
meet their unique needs, they have more growth academically, are more
socially competent, and lead happier and more successful lives at home
and in their communities. It is critical to note that lasting effects
of inclusive practices in schools extend far beyond the school setting
making children a part of their community, helping them develop a sense
of belonging and becoming better prepared for life.
Providing children with the resources to attend schools which are
committed to and prepared for inclusive practices, demonstrates the
shared commitment to having all children feel appreciated and accepted
throughout life. All children deserve to attend age appropriate regular
classrooms to the maximum extent possible receiving curriculum relevant
to their needs that will provide for their educational success. All
children benefit from cooperation, collaboration among home, among
school, among community.
Thank you for your time and consideration.
[This statement was submitted by Jessica Saum, Special Education
Teacher,
Association of American Educators Advocacy Fellow.]
______
Prepared Statement of the Association of American Medical Colleges
The Association of American Medical Colleges (AAMC) is a not-for-
profit association dedicated to transforming health through medical
education, health care, medical research, and community collaborations.
Its members are all 155 accredited U.S. and 17 accredited Canadian
medical schools; more than 400 teaching hospitals and health systems,
including Department of Veterans Affairs medical centers; and more than
70 academic societies. Through these institutions and organizations,
the AAMC?leads and serves America's medical schools and teaching
hospitals and their more than 179,000 full-time faculty members, 92,000
medical students, 140,000 resident physicians, and 60,000 graduate
students and postdoctoral researchers in the biomedical sciences.
The COVID-19 pandemic has illustrated how sustained support for the
research, education, and patient care missions of medical schools and
teaching hospitals, with a strong commitment to community
collaborations, is essential to ensure a resilient health care
infrastructure prepared to respond to both novel and existing threats.
For FY 2022, the AAMC recommends the following for federal priorities
essential in assisting medical schools and teaching hospitals to
fulfill their missions that benefit patients, communities and the
nation: at least $46.1 billion for the National Institutes of Health
(NIH); $500 million for the Agency for Healthcare Research and Quality
(AHRQ); $1.51 billion for the Health Resources and Services
Administration (HRSA) Title VII health professions and Title VIII
nursing workforce development programs, and $485 million for the
Children's Hospitals Graduate Medical Education (CHGME) program; and at
least $10 billion for the Centers for Disease Control and Prevention
(CDC). The AAMC appreciates the Subcommittee's longstanding, bipartisan
efforts to strengthen these programs. Additionally, to enable the
necessary support for the broad range of critical federal priorities,
the AAMC urges Congress to approve a funding allocation for the Labor-
HHS subcommittee that enables full investment in the priorities
outlined below.
National Institutes of Health. Congress's longstanding bipartisan
support for medical research has contributed greatly to improving the
health and well-being of all Americans, highlighted by the central role
medical research has played in combatting COVID-19. As illustrated over
the last year, the foundation of scientific knowledge built through
NIH-funded research drives medical innovation that improves health
through new and better diagnostics, improved prevention strategies, and
more effective treatments. Over half of the life-saving research
supported by the NIH takes place at medical schools and teaching
hospitals, where scientists, clinicians, fellows, residents, medical
students, and trainees work together to improve the lives of Americans
through research. This partnership is a unique and highly productive
relationship that lays the foundation for improved health and quality
of life and strengthens the nation's long-term economy.
The AAMC thanks Congress for the bipartisan support that resulted
in the inclusion of $42.9 billion for medical research conducted and
supported by the NIH in the FY 2021 omnibus spending bill.
Additionally, the AAMC thanks the Subcommittee for recognizing the
importance of retaining the salary cap at Executive Level II of the
federal pay scale in FY 2021, and for the emergency resources that have
advanced COVID-19 research.
In FY 2022, the AAMC joins nearly 400 partners in supporting the Ad
Hoc Group for Medical Research recommendation that Congress provide at
least $46.1 billion in program level funding for the NIH, including
funds provided through the 21st Century Cures Act for targeted
initiatives. This funding level for the foundational work at the core
of NIH's mission would continue the momentum of recent years by
enabling meaningful growth of 5% in the NIH's base budget over
biomedical inflation to help ensure stability in the nation's research
capacity long term. Securing a reliable, robust budget trajectory is
key in positioning the agency--and the patients who rely on the
research it funds--to capitalize on the full range of research in the
biomedical, behavioral, social, and population-based sciences. We must
continue to strengthen our nation's research capacity, solidify our
global leadership in medical research, ensure a research workforce that
reflects the racial and gender diversity of our citizenry, and inspire
a passion for science in current and future generations of researchers.
In addition to our strong support for a robust increase in NIH's
base funding, we look forward to working with lawmakers and the
administration to fulfill the goals of the proposed Advanced Research
Projects Agency for Health (ARPA-H) within NIH as part of the
administration's $52 billion request for the NIH to ``drive
transformational health research innovation and speed medical
breakthroughs by tackling ambitious challenges requiring large-scale,
sustained, and cross-sector coordination.'' The nation's medical
schools and teaching hospitals are hubs of innovation in research and
care delivery, and the AAMC looks forward to engaging with lawmakers
and the administration on opportunities to advance a bold and
productive medical research agenda in harnessing our shared commitment
to innovation and scientific discovery.
We also wish to highlight the challenges that the pandemic has
imposed on the medical research workforce and the broader research
enterprise. We continue to be concerned that, without supplemental
resources, the disruptions imposed by COVID-19 will undermine NIH's
ability to support previous investments in the existing research
workforce and new investments in life-saving research. In his recent
testimony before the subcommittee, NIH Director Francis Collins, MD,
PhD, cited the $16 billion impact of the coronavirus pandemic on
medical research progress in all disease areas, and especially on the
research workforce. We urge support for emergency funding for NIH as
outlined in the bipartisan Research Investment to Spark the Economy
(RISE) Act (H.R. 869/S.289).
Agency for Healthcare Research and Quality. Complementing the
medical research supported by NIH, AHRQ sponsors health services
research designed to improve the quality of health care, decrease
health care costs, and provide access to essential health care services
by translating research into measurable improvements in the health care
system. The AAMC joins the Friends of AHRQ in recommending $500 million
in funding for AHRQ in FY 2022.
Health Professions Funding. The Health Resources and Services
Administration (HRSA) Title VII and Title VIII programs have helped the
country combat COVID-19, despite the challenges the pandemic posed for
grantees. Many grantees adapted their curricula to educate our health
workforce during this public health challenge. They also dealt with the
unexpected costs of providing personal protective equipment for in-
person clinical training and switching from in-person to virtual
learning. The pandemic has underscored the need to increase and
continuously reshape our health workforce. The programs have proven
successful in recruiting, training, and supporting public health
practitioners, nurses, geriatricians, mental health providers, and
other front-line health care workers critical to addressing COVID-19.
Additionally, in coordination with HRSA, grantees have used innovative
models of care, such as telehealth, to improve patients' access to care
during the pandemic.
The COVID-19 pandemic has also highlighted the pervasive health
inequities facing minority communities and gaps in care for our most
vulnerable patients, including an aging population that requires more
health care services. The HRSA Title VII and Title VIII programs
educate current and future providers to serve these ever-growing needs,
while preparing providers for the health care demands of tomorrow. A
diverse health care workforce improves access to care, patient
satisfaction, and health professionals' learning environments. Studies
show that HRSA Title VII and Title VIII programs increase the number of
underrepresented students enrolled in health professions schools,
heighten awareness of factors contributing to health disparities, and
attract health professionals more likely to treat underserved patients.
The AAMC joins the Health Professions and Nursing Education Coalition
(HPNEC) in recommending $1.51 million for these critical workforce
programs in FY 2022.
In addition to Title VII and Title VIII, HRSA's Bureau of Health
Workforce also supports the CHGME program, which provides critical
federal graduate medical education support for children's hospitals to
train the future primary care and specialty care workforce for our
nation's children. We support $485 million for the CHGME program in FY
2022. We also encourage Congress to provide robust funding to HRSA's
Rural Residency Programs, which provides funding to develop new rural
residency programs or separately accredited rural training track
programs, to expand training opportunities in rural areas.
The AAMC encourages Congress to provide long-term sustained funding
for the National Health Service Corps (NHSC), through its mandatory and
discretionary mechanisms. We were appreciative of the $800 million in
supplemental funding for the NHSC in the American Rescue Plan (H.R.
117-2), and we support an appropriation for the NHSC that would fulfill
the needs for current Health Professions Shortage Areas.
Centers for Disease Control and Prevention. The AAMC joins the CDC
Coalition in a recommendation of at least $10 billion for the CDC in FY
2022. In addition to ensuring a strong public health infrastructure and
protecting Americans from public health threats and emergencies, CDC
programs are crucial to reducing health care costs and improving
health. Within the CDC total, the AAMC supports $102.5 million for the
Racial and Ethnic Approaches to Community Health (REACH) program and
$25 million to support gun safety research.
Additional Programs. The AAMC also supports at least $474 million
for the Hospital Preparedness Program within the Office of the
Assistant Secretary for Preparedness and Response (ASPR), in addition
to $40 million to continue the regional preparedness programs created
to address Ebola and other special pathogens, including funding for
regional treatment centers, frontline providers, and the National
Emerging Pathogen Training and Education Center (NETEC).
Once again, the AAMC appreciates the opportunity to submit this
statement for the record and looks forward to working with the
subcommittee as it prepares its FY 2022 spending bill.
______
Prepared Statement of the Association of Farmworker Opportunity
Programs
Chair Murray and Ranking Minority Member Blunt:
Thank you for the opportunity to present to you and your
subcommittee the testimony of the Association of Farmworker Opportunity
Programs (AFOP) in support of the nation's more than 50-year commitment
to providing eligible agricultural workers the opportunity to achieve
the American Dream for themselves and their families. As you begin work
on your fiscal year 2022 Labor-Health and Human Services-Education
appropriations bill, AFOP encourages you to build on the foundations
laid by the highly successful programs described below by adequately
funding them in the coming fiscal year: National Farmworker Jobs
Program (NFJP), United States Department of Labor (DOL) Employment and
Training Administration ($98,896,000); and Susan Harwood Training
Grants, DOL Occupational Safety and Health Administration
($10,537,000). Not only do these programs maximize the Federal
government's investment in them, they also generate for employers the
qualified and healthy workers essential to their growth. These programs
also dramatically change peoples' lives for the better, often in rural
areas, allowing them to enjoy economic success and participate more
fully in our great nation. Thank you for supporting these very
effective programs and the excellent results they bring for society's
most vulnerable.
national farmworker jobs program
NFJP is the bedrock of the nation's commitment to helping
agricultural workers upgrade their skills in and outside agriculture,
providing employers with what they increasingly say they need:
hardworking, well-trained, skilled workers. Administered by DOL, NFJP
provides funding through a competitive grant process to 54 community-
based organizations and public agencies nationwide that assist workers
and their families to attain greater economic stability. One of DOL's
most successful employment training programs, NFJP helps agricultural
workers acquire the new skills they need to start careers that offer
higher wages and a more stable employment outlook. In addition to
employment and training services, the program provides supportive
services that help agricultural workers retain and stabilize their
current agriculture jobs, as well as enable them to participate in up-
training and enter new careers. NFJP housing assistance helps meet a
critical need for the availability and quality of agricultural worker
housing and supports better economic outcomes for workers and their
families. NFJP also facilitates the coordination of services through
the American Job Center network for agricultural workers so they may
access other services of the public workforce system.
The agricultural workers who come to NFJP seek training to secure
and excel in the in-demand jobs employers say they find challenging to
fill. In doing so, the workers establish the financial foundation that
allows them and their families to escape the chronic unemployment and
underemployment they face each year. Many NFJP participants enter
construction, welding, healthcare, and commercial truck-driving. Others
train for the solar/wind energy sector, culinary arts, and for
positions such as machinists, electrical linemen, and a variety of
careers in and outside of agriculture. To be eligible for NFJP, workers
must be low-income, depend primarily on agricultural employment, and
provide proof of American citizenship or work authorization.
Additionally, male applicants must have registered with the Selective
Service.
Agricultural workers are some of the hardest working individuals in
this country, enduring tremendous physical and financial hardships in
providing produce Americans eat every day. Yet, agricultural workers
remain among the nation's most vulnerable employees and job seekers,
facing significant barriers to work advancement, including:
--The average agricultural worker family of four earns just $20,000
per year, well below the national poverty line.
--English-language fluency is a substantial challenge for many.
--More than half the children of migratory agricultural workers drop
out of school, and, among all agricultural workers, the median
highest grade completed is 9th grade (National Agricultural
Workers Survey).
--Due to poverty and their rural locations, most agricultural workers
have extremely limited access to transportation.
Despite these barriers, NFJP continues to be one of the most
successful Federal job training programs, exceeding all DOL's goals. In
2019 alone, NFJP service organizations provided more than 17,300
agricultural workers with services, according to DOL. These NFJP
providers have served more than an estimated 170,000 agricultural
workers and their family members over the last 10 years. Funding
program this year at $98,896,000 would allow NFJP to train even more
dependable, capable workers to take on the nation's most challenging
jobs, such as those needed to rebuild the nation's infrastructure.
Also, consistent appropriations for youth agricultural workers (ages
14- to 24-years) will allow this cohort, so often overlooked and
ignored by anti-poverty programs, to stay in school, and, if not in
school, to avail themselves of crucial training to get a good job and
establish themselves as productive and successful members of society.
agricultural worker health & safety
AFOP also supports appropriations for OSHA's Susan Harwood grant
program, through which AFOP has augmented pesticide safety training
with curricula to help workers recognize and avoid the dangers of heat
stress so common in the fields. In supporting this funding, you can arm
the nation's agricultural workers with the knowledge they need to keep
themselves safe on the job. The NFJP network of some 220 trainers in 30
states trains agricultural workers on how to protect against pesticide
poisoning. Trainers then follow up with agricultural workers to assess
knowledge gained and retained, and changes in labor practice. Since
1995, more than 492,000 agricultural workers have become certified as
trained in safety precautions, and hundreds of thousands of family
members, children, and community agencies have also received safety
training. The network collaborates with universities, community
organizations, local governments, and businesses to maximize its
unparalleled access to agricultural workers and their families. By
reaching agricultural workers with pesticide safety training, the
network's trainers offer access to other services and create a ripple
effect of positive impact--improving the quality of life for
agricultural workers and their families--which is what NFJP
organizations do best.
Thank you for supporting these worthy programs. AFOP stands ready
to assist you in any way as you proceed with your very important work.
[This statement was submitted by Daniel J. Sheehan, Executive
Director,
Association of Farmworker Opportunity Programs.]
______
Prepared Statement of the Association of Independent Research
Institutes
The Association of Independent Research Institutes (AIRI) thanks
the Subcommittee for its long-standing and bipartisan leadership in
support of the National Institutes of Health (NIH). We continue to
believe that science and innovation are essential if we are to improve
our nation's health, sustain our leadership in medical research, and
remain competitive in today's global information and innovation-based
economy. AIRI urges the Subcommittee to provide NIH with at least $46.1
billion in fiscal year (FY) 2022. AIRI also commends Congress for
continuing to reject harmful policies such as reducing support for
facilities and administrative (F&A) costs or investigator salary
support on NIH grants. In addition, AIRI looks forward to working with
the Subcommittee and the Biden Administration to explore how the
proposed Advanced Research Project Agency for Health (ARPA-H) can
support high-risk, high-reward research to quickly develop new cures.
AIRI urges the Subcommittee to ensure that this proposed effort
complements, and does not negatively impact, NIH's funding for
fundamental biomedical research that is critical for understanding and
addressing the public health challenges facing the United States.
AIRI is a national organization of more than 90 independent, non-
profit research institutes that perform basic and clinical research in
the biological and behavioral sciences. AIRI institutes vary in size,
with budgets ranging from a few million to hundreds of millions of
dollars. In addition, each AIRI member institution is governed by its
own independent Board of Directors, which allows our members to focus
on discovery-based research while remaining structurally nimble and
capable of adjusting their research programs to emerging areas of
inquiry. Investigators at independent research institutes consistently
exceed the success rates of the overall NIH grantee pool, and they
receive about ten percent of NIH's peer-reviewed, competitively awarded
extramural grants.
AIRI thanks the Subcommittee for providing an increase of $1.25
billion for NIH in the FY 2021 Consolidated Appropriations Act. The
Subcommittee's support of NIH is strongly demonstrated by these much-
needed funds for life-saving biomedical research. However, there is
still much more to do. NIH is tackling vast, interdisciplinary problems
such as cancer, Alzheimer's Disease, emerging infectious diseases, and
the opioid crisis, among others. In addition, NIH's instrumental role
in developing new vaccines to combat the COVID-19 pandemic reminds us
that now is not the time to pull back on needed investments in the
nation's biomedical research ecosystem. Continued budget certainty is
needed for the agency to predictably fund new and ongoing grants and
consider new initiatives necessary to improving human health and
ensuring that we are prepared for the next public health crisis. To
ensure cutting-edge research at independent research institutes is not
disrupted, AIRI strongly supports a topline of $46.1 billion for NIH in
FY 2021.
AIRI thanks the Subcommittee and Congress for providing critically
needed supplemental funding in 2020 to combat the COVID-19 pandemic.
NIH investments were critical in the record-breaking development of
multiple vaccines and improved treatments and therapeutics for COVID-
19. Independent research institutions are, by design, structurally
nimble and responsive to emerging research issues. In part because of
this, AIRI members have made significant contributions to COVID-19
research. Selected examples include:
--The Fred Hutchison Cancer Research Center's and RTI International's
role in the Accelerating COVID-19 Therapeutic Interventions and
Vaccines (ACTIV) program essential for the development of
treatments and vaccines.
--Fred Hutch's work in modeling the spread and evolution of COVID-19
and as the coordination center for the NIH-funded COVID-19
Prevention Network.
--La Jolla Institute of Immunology's pioneering work to understand T
cell responses to the infection.
--Jackson Lab's work in developing a line of ACE2 mice for
preclinical studies.
Not only is NIH research essential to advancing health, it also
plays a key economic role in communities nationwide. In FY 2020, NIH
invested $34.65 billion, or almost 80 percent of its budget, in the
biomedical research community. This investment supported more than
536,338 jobs nationwide and generated nearly $91.35 billion in economic
activity across the U.S.\1\ AIRI member institutes are particularly
relevant in this regard, as they are located across the country,
including in many smaller or less-populated states that do not have
major academic research institutions. In many of these regions,
independent research institutes are major employers and local economic
engines, and they exemplify the positive impact of investing in
research and science.
---------------------------------------------------------------------------
\1\ NIH's funding information and economic impact data comes from
United for Medical Research's 2021 State-By-State Update, https://
www.unitedformedicalresearch.org/wp-content/uploads/2021/03/NIHs-Role-
in-Sustaining-the-U.S.-Economy-FINAL-3.23.21.pdf.
---------------------------------------------------------------------------
The NIH model for conducting biomedical research, which involves
supporting scientists at independent research institutes, medical
centers, and universities provides an effective approach to making
fundamental discoveries in the laboratory that can be translated into
medical advances that save lives. AIRI member institutions are private,
stand-alone research centers that set their sights on the vast
frontiers of medical science. However, AIRI member institutes are
especially vulnerable to reductions in the NIH budget, as they do not
have other reliable sources of revenue to make up the shortfall.
AIRI member institutes' flexibility and research-only missions
provide an environment particularly conducive to creativity and
innovation. Independent research institutes possess a unique
versatility and culture that encourages them to share expertise,
information, and equipment across research institutions, as well as
neighboring universities. These collaborative activities help minimize
bureaucracy and increase efficiency, allowing for fruitful partnerships
in a variety of disciplines and industries. Also, unlike institutes of
higher education, AIRI member institutes focus primarily on scientific
inquiry and discovery, allowing them to respond quickly to the research
needs of the nation.
AIRI looks forward to working with Congress and the Biden
Administration to examine how the proposed establishment of an ARPA-H
can push the research enterprise to take on high-risk, high-reward
research efforts. If successful, an ARPA-H has the potential to convene
researchers to take on grand challenges in public health that were
previously thought to be impossible to solve. However, we still do not
fully understand many of the basic mechanisms underlying diseases and
public health challenges facing the nation today, such as cancer,
Alzheimer's, and addiction, among others. Funding for fundamental
research is still crucial to address these issues, and AIRI urges the
Subcommittee to ensure that new proposals do not negatively impact
these important ongoing efforts.
The U.S. has the most robust medical research enterprise in the
world, but our leadership in biomedical research is being challenged by
the investments being made in the research capacity of other nations,
such as China. While the most recent funding increases to the NIH
budget will greatly help sustain biomedical research in the U.S., it is
important to continue providing stable funding to uphold our biomedical
excellence.
AIRI deeply thanks the Subcommittee for its important work
dedicated to ensuring the health of the nation, and we appreciate this
opportunity to urge the Subcommittee to continue the success of NIH by
providing $46.1 billion in FY 2021 and reaffirming support for NIH's
current F&A and investigator salary policies to strengthen our nation's
investment in life-saving medical research.
______
Prepared Statement of the Association of Minority Health Professions
Schools
summary of fiscal year 2022 recommendations
_______________________________________________________________________
Health Resources and Services Administration:
--$1.51 billion for the Health Resources and Services Administration
(HRSA) Title VII health professions and Title VIII nursing
workforce development programs.
--$47.42 million for HRSA's Minority Centers of Excellence
--$47.95 million for HRSA's Health Careers Opportunity Program.
--$2 million for HRSA's Minority Faculty Loan Repayment Program.
--$67 million for HRSA's Scholarships for Disadvantaged Students
(SDS).
--$67 million for HRSA's Area Health Education Center (AHEC)
Program
Centers for Disease Control and Prevention:
--$74 million for the Racial and Ethnic Approaches to Community
Health (REACH) Program
National Institutes of Health:
--$46.1 billion for the National Institutes of Health
--1 billion for the National Institute on Minority Health and
Health Disparities (NIMHD).
-- $300 million for the Research Centers at Minority Institutions
(RCMI)
--$200 million in new, annual research funding dedicated
specifically targeted at enabling historically black health
professions schools to support research that reverses
health status disparities among minority Americans.
--$100 million for NIH's Extramural Research Facilities program
--$100 million to reinvigorate the NIMHD's Research Endowment
Program (REP)
Office of the Secretary:
--$72 million for the Office of Minority Health at the Department of
Health and Human Services.
--$5 billion in new funding designated for Historically Black Health
Professions Institutions for the improvement and development of
health care infrastructure.
Department of Education:
--$100 million for the Strengthening Historically Black Graduate
Institutions (HBGI) Program.
_______________________________________________________________________
Chairwoman Murray, Ranking Member Blunt, and distinguished members
of the subcommittee, thank you for the opportunity to submit testimony
and thank you for your leadership in addressing challenges facing the
health workforce, health disparities, and medically underserved
communities. I am Dr. Kathleen Kennedy, Malcolm Ellington Professor of
Health Disparities Research and Dean, College of Pharmacy Xavier
University of Louisiana and the Chair of the Association of Minority
Health Professions Schools (AMHPS), which was established in 1976 to
promote a national minority health agenda by addressing the needs of
the health workforce and improving health status in medically-
underserved communities. Speaking to you today against the backdrop of
the continued COVID-19 pandemic with hope on the horizon, we have
learned valuable lessons over the past year and a half, but we know
that there is more work to be done. The pandemic has pulled back the
curtain on what many of AMHPS institutions know and work towards
everyday: the pitfalls and shortcomings of minority health. Given the
recent deluge of media coverage surrounding this disheartening topic,
the country is primed and ready to act in a meaningful way. Our funding
recommendations are robust and we realize ambitious, however there have
rightfully been discussion concerning the devastating effect of the
pandemic on people of color and the need to address this effect for any
future pandemic. To be as clear we can be, there must be more robust
investment on minority health and disparities. To achieve this we know
that it will require the steadfast leadership of health equity
champions. We stand ready to work with you and your colleagues to
facilitate these efforts.
AMHPS is comprised of the twelve historically black medical,
dental, pharmacy, and veterinary schools in the United States. The
members are two schools of dentistry at Howard University and Meharry
Medical College; four schools of medicine, at Charles R. Drew
University, Howard University, Meharry Medical College, and Morehouse
School of Medicine; five schools of pharmacy, at Florida A&M
University, Howard University, Texas Southern University, Hampton
University, and Xavier University; and one school of veterinary
medicine, at Tuskegee University. Today, the association assists its
member institutions in the expansion and enhancement of educational
opportunities in the health professions for minorities and
disadvantaged students and disadvantaged people. AMHPS continuously
adheres to is founding call and honors its threefold mission to improve
the health status of blacks and other minorities; improve the
representation of blacks and other minorities in the health
professions; strengthen our institutions and programs and to strengthen
other programs throughout the nation, which in turn will improve the
role of minorities in the provision of health care.
Health disparities across racial and ethnic groups in the U. S.
have been well documented over the last several decades and have
remained remarkably persistent in spite of the changes in many facets
of the society over that period. Moreover, the benefits of increasing
diversity in the health professions to reduce such disparities have
been studied at length, are based on empirical data, and are well
understood by the medical community. Examples of these benefits
include:
--Minority physicians are more likely to practice in medically
underserved areas and care for patients regardless of their
ability to pay.
--Minority physicians are more likely to choose primary care
practices.
--Evidence suggests that improving cross-cultural communication
between doctors and patients and providing patients with access
to a diverse group of doctors improve adherence, satisfaction
and health outcomes.
--There is evidence that the intellectual, cultural sensitivity,
competency, and civic development of students is enhanced by
learning in a diverse educational environment.
--A diverse health workforce encourages a greater number of
minorities to enroll in clinical trials designed to alleviate
health disparities.
There is little left to discover or dispute with respect to the
benefits of achieving greater racial and ethnic diversity of the
nation's health professionals--the attention has once again shifted to
identifying the most effective and sustainable methods to do so. While
there are many national campaigns underway to increase diversity in all
medical and health professions schools particularly during this period
of enrollment growth, it is imperative that we further recognize and
leverage the public value of Historically Black Health Professions
Schools.
The daunting news that Blacks Americans in the US are
disproportionately suffering and dying from the novel coronavirus
(COVID-19) unfortunately was not a tremendous surprise to those of us
who regularly monitor and understand health status disparities in this
nation. There are well-known health status challenges faced daily by
Black Americans and minority health care providers, it also represents
a surrogate for the glaring lack of health infrastructure in medically
under-served communities. At AMHPS institutions, we have long been and
remain committed to addressing these very same disparities in whatever
way that we can, with an eye first and foremost towards the communities
with the greatest need across our country.
Ironically, as a result of their mission focus the financial models
of historically black health professions schools are uniquely
disadvantaged compared to most of their peer institutions. Unlike
subspecialty-oriented, research-intensive institutions--with higher
margin clinical services, an integrated hospital system, substantial
research enterprises, sizeable endowments, and a critical mass of
wealthy donors--these institutions are faced with an unprecedented set
of adverse factors that challenge their financial viability.
Consequently, they are disproportionately dependent on the various
federal programs that support their core purpose.
Specifically, these programs include: the Title VII Health
Professions Training Programs administered by the Health Resources and
Services Administration (HRSA) of the Department of Health and Human
Services (HHS); the Research Centers at Minority Institutions (RCMI),
the Extramural Research Facilities; the Research Endowment; and Centers
of Excellence programs administered the National Institutes of Health's
National Institute on Minority Health and Health Disparities; and the
Historically Black Graduate Institution (HBGI) program administered by
the Office of Postsecondary Education of the U.S. Department of
Education (DOE).
Madam Chair, unfortunately, over the past several years funding for
diversity-focused programs has deteriorated in varying degrees. Absent
a monumental overall investment the financial position and academic
viability of historically black health professions schools will
deteriorate rapidly. The front loaded investment in health professions
training programs, graduate programs in biomedical sciences and public,
and safety net providers is more cost effective than absorbing
uncompensated care originating from minority and underserved
communities. Now is the time for targeted investments in historically
black health professions schools to ensure a steady pipeline of
minority healthcare providers, biomedical scientists, and other health
practitioners prepared to support and advance the delivery of high
quality, culturally appropriate, evidence based health care. Thank you
all again for the opportunity to share the priorities of the
Association of Minority Health Professions Schools.
[This statement was submitted by Kathleen B. Kennedy, Pharm.D.,
Chair,
Association of Minority Health Professions Schools, Inc. and Malcolm
Ellington,
Professor, Health Disparities Research and Dean, College of Pharmacy
Xavier
University of Louisiana.]
______
Prepared Statement of the Association of State and
Territorial Health Officials
On behalf of the Association of State and Territorial Health
Officials (ASTHO), I respectfully submit this testimony on FY22
appropriations for the U.S. Department of Health and Human Services
(HHS). ASTHO is requesting $10 billion for the Centers for Disease
Control and Prevention (CDC), $824 million for the Public Health
Emergency Preparedness Cooperative Agreement (PHEP), $149 million for
the CDC Preparedness and Response, All Other CDC Preparedness line,
$170 million for the Preventive Health and Health Services Block Grant
(Prevent Block Grant), and $250 million for the data modernization
effort at the CDC. Under the Assistant Secretary for Preparedness and
Response (ASPR), ASTHO is requesting $474 million for the Hospital
Preparedness Program (HPP) and not less than $45.6 million to sustain
the Regional Treatment Network for Ebola and Other Special Pathogens
(RTNESP) and the National Ebola Training and Education Center (NETEC).
Additionally, we are requesting $9.2 billion in discretionary funding
for the Health Resources and Services Administration (HRSA).
You are probably wondering, ``Why is governmental public health at
the table requesting more funding? Didn't Congress just provide
billions of dollars in emergency funding for you all?'' The answers are
yes and thank you. We all must recognize the sheer amount of emergency
funding required to boost our public health system and respond to the
COVID-19 pandemic. We must also acknowledge that huge sums of this
emergency funding could have been avoided with ongoing, predictable
funding that meets the needs of state, territorial, and local public
health departments. The emergency supplemental funding is narrow,
specific, and time limited. All too often, after emergency supplemental
funding expires, health officials are forced to shut down programs,
allow software licenses to expire, furlough staff, and move on. While
there are billions of emergency supplemental dollars in the system
right now--that we are immensely grateful for--we anticipate that,
without a change of course, there will be an enormous funding cliff in
two to three years. Meanwhile, we all know that communities of color
are disproportionately impacted by underinvestment on all public health
fronts, whether we are discussing maternal morbidity and mortality,
infant mortality, the prevalence of chronic diseases, substance use and
misuse, behavioral and mental health, the HIV epidemic, and most
strikingly, overall life expectancy. We have an opportunity to make
things better for the American people, especially for those who need it
most. This committee and Congress can ensure we have sustained,
predictable, and increased funding for all of public health, which
translates into better lives for those we serve.
ASTHO is the national nonprofit organization representing the
public health agencies of the United States, the U.S. territories and
freely associated states, and the District of Columbia. ASTHO members,
the chief health officials of these jurisdictions, are dedicated to
ensuring excellence in public health practice. The mission of our
nation's governmental health agencies is to protect and improve the
health of the population, everywhere, every day. Our members' mission
is to provide the leadership, expertise, information, and tools to
assure conditions in which all residents can be healthy. In short:
Keeping people safe.
America's state and territorial public health departments work in
strong partnership with CDC toward this goal. For this essential task,
we request $10 billion in overall funding for CDC. CDC plays a vital
role in supporting communities to expand the capacity of our nation's
front line of public health defense: Our country's state, tribal,
territorial, and local public health departments. Through this
partnership with CDC, state and territorial health agencies work across
the country to prevent avoidable diseases, promote healthy communities,
protect the public's health, and ensure the vibrance and security of
our economy. These resources also support disease-neutral
infrastructure such as data and information technology systems,
workforce development, community partnership building, and
administrative preparedness. We continue to learn how far behind we are
as a country when it comes to our ability to accurately track diseases
or even transmit data efficiently and accurately to a central location.
ASTHO is thankful for the current investment in our public health
systems, but dependable and appropriate financing is essential to keep
our country ahead of the curve.
Public health preparedness requires support at the federal level
and implementation by state, territorial, and local jurisdictions.
Recognizing this, ASTHO requests $824 million for PHEP at CDC.
America's public health preparedness outlays have operated in a
punctuated equilibrium. We make leaps forward after emergencies such as
September 11, Ebola, Zika, and measles outbreaks, and then are lulled
into periods of stasis for far too long. PHEP requires ongoing and
increased funding to ensure that lessons and improvements from the
COVID-19 response are not lost. In close partnership with the PHEP is
the Hospital Preparedness Program (HPP) at ASPR, for which ASTHO
requests $474 million. As the only source of federal funding that
supports regional healthcare system preparedness, HPP promotes a
sustained national focus to improve patient outcomes, minimizes the
need for supplemental state and federal resources during emergencies,
and enables rapid recovery. Now more than ever, we clearly understand
the importance of public health and healthcare preparedness programs
working collaboratively and with proper resources. We are also
requesting that Congress provide no less than $49.5 million to sustain
the National Emerging Special Pathogen Training and Education Center
and the 10 existing regional Ebola and other special pathogen treatment
centers under ASPR. The investment made in this system over five years
ago has proven its importance in providing specialty treatment,
training, and national-level expertise during the COVID-19 response.
This network is a valuable front-line tool in protecting our country.
Preventing disease in the first place is the most economical use of
our public funds when it comes to health spending. ASTHO's members
strive to implement locally tailored, innovative programs that not only
prevent disease and disability but support wellness as we work toward
national health priorities. For this, ASTHO requests $170 million for
the Prevent Block Grant. Programs funded by the Prevent Block Grant
cannot be adequately supported or expanded through other funding
mechanisms. The success of the Prevent Block Grant is achieved by using
evidence-based methods and interventions, reducing risk factors,
leveraging other funds, and continuing to monitor and reevaluate funded
programs.
ASTHO appreciates this committee's ongoing support of CDC's data
modernization initiative. Public health is singlehandedly keeping the
fax industry alive, and we must leap forward. We applaud Congress's
investment and down payment to date ($600 million through FY21 and FY21
funding and the CARES Act) and the inclusion of language authorizing
activities to improve the public health data systems at CDC in the
Consolidated Appropriations Act for FY21. We respectfully request the
Subcommittee continue to provide sustained annual funding of at least
$250 million for the public health Data Modernization Initiative at
CDC.
ASTHO is also encouraged by the Administration's plan to end the
HIV epidemic and address social determinants of health in America.
State and territorial health officials look forward to working with
federal and local partners across the country to bring effective
strategies to scale. State, territorial, local, and tribal
jurisdictions, community-based organizations, and healthcare partners
must have the resources necessary to enhance and deliver these
evidence-based public health interventions.
While the pandemic is at the forefront of our minds, we have never
fully addressed the ongoing crisis in our country caused by substance
misuse, addiction, and drug overdoses. ASTHO is appreciative of
previous investments in public health to address this crisis. We
respectfully request Congress to sustain activities and continue the
response to the opioid epidemic and substance abuse and misuse
disorders more broadly.
CDC is not the only federal agency that strives to improve the
public's health in states and territories. ASTHO is requesting $9.2
billion for discretionary funding for HRSA. HRSA administers programs
that focus on improving care for tens of millions of Americans who are
medically underserved or face barriers to needed care by strengthening
the health workforce.
As you look to the FY22 discretionary appropriations bills, we
strongly urge you to build a base funding for public health--through
CDC, ASPR, and HRSA--that is sustainable and predictable. Thank you so
much for your time and consideration of our request. We stand ready to
continue working toward optimal health for all.
[This statement was submitted by Michael Fraser, PhD, MS, CAE,
FCPP, Chief Executive Officer, Association of State and Territorial
Health Officials.]
______
Prepared Statement of the Association of University Programs in
Occupational Health and Safety
On behalf of the Association of University Programs in Occupational
Health and Safety (AUPOHS), we respectfully request that the Fiscal
Year 2022 Labor, Health, and Human Services Appropriations bill include
no less than $375,300,000 for the National Institute for Occupational
Safety and Health (NIOSH), including no less than $34,000,000 for the
Education and Research Centers (ERCs), $30,500,000 for the Agriculture,
Forestry, and Fishing (AgFF) Program, and a $4,000,000 increase over
the FY21 level for the Total Worker Health(r) (TWH) Program.
As you have no doubt heard from other testimonies, far too many
Americans still lose their lives on the job. In 2019, a worker died
every 99 minutes from injuries they got on the job (BLS 2020). This
includes our first responders, who can be struck and killed by drivers
while helping victims of a roadside traffic accident; our construction
workers, who may fall from an inadequately marked or guarded roof edge;
and our shop owners and employees who may be asked to work late nights
without proper security and become victims of violence. Although it is
harder to measure, we also estimate that an additional 145 people die
every day in America from work-related disease--developing cancers from
hazardous chemicals that we encounter at work, or heart disease from
our chronically stressful work environments. In addition to work-
related deaths, we also have a high burden of non-fatal workplace
injury and illness. Leading up to the pandemic, 2.8 million workers
were seriously injured on the job every year and one-third of those
injured workers required time off to recover before they could return
to work. This not only costs the nation's businesses more than $1.1
billion a week on serious, nonfatal workplace injuries (Liberty Mutual
2020) but also causes great harm to workers and their families if their
workers' compensation systems fail to provide adequate care or wage
replacement.
The pandemic has amplified all of these issues for the American
workforce. More than 3,600 of our health care workers died from COVID-
19 in the first year of the pandemic, and we know that many of these
deaths are attributable to the extreme shortage of protective gear
encountered in medical settings (Lost on the Frontline 2021). That is
to say, these deaths were preventable. In just the first months of the
pandemic, 16,233 workers in meat and poultry processing facilities were
infected with COVID-19 (CDC 2020); these were also workers who
sacrificed their health and wellbeing in order to keep essential goods
and services moving. We owe an immense debt to all of our essential
workers, and as such, we have an opportunity to better serve these
workers moving forward. By designing safer workplaces that reduce the
risk of exposure to future variants, answering workers' questions about
vaccines and making them accessible, and by researching, designing, and
preparing programs to bolster workers' mental health as we come to
terms with what we have experienced this past year, we can serve our
essential workers.
NIOSH is the primary federal agency responsible for conducting
research that leads to actions and policies that prevent work-related
illness and injury by promoting safe work practices and work
environments as well as worker health and well-being. NIOSH is also the
federal agency charged with certifying and approving Personal
Protective Equipment (PPE), including the masks that are necessary to
protect U.S. workers from inhalation exposures to chemical and
biological agents, including viruses. During this pandemic, NIOSH has
accelerated the approval process for establishing the safety and
quality of new masks and other PPE. NIOSH continues to fund and promote
critical research for a changing workforce and work practices, an
important service for employers and employees in the face of the
current pandemic and other disasters. NIOSH has, for example, deployed
teams across the country in response to industry requests for
assistance, including more than 15 meatpacking plants that experienced
outbreaks. NIOSH has contributed key leadership and expertise,
providing federal guidance and decision tools for industries including
construction, manufacturing, food and agriculture, mass transit,
transportation and trucking, restaurants and bars, childcare
facilities, schools, among others, including recent guidance for
businesses to safely return to work and/or expand operations.
The NIOSH-supported extramural Centers, including the Education and
Research Centers (ERCs), Centers in the Agriculture, Forestry, and
Fishing (AgFF) Program, and the Total Worker Health(r) (TWH) Centers of
Excellence, have responded rigorously to the pandemic and supported
NIOSH to rapidly respond to the needs and safety of the nation's
workforce. These Centers have been proactive in providing resources,
employer assistance, over 100,000 hours of outreach training, and
research that are helping to drive improvements in our rapid response
to emerging occupational safety and health issues. The work the Centers
have undertaken during this pandemic underscores the need for increased
funding for NIOSH and the Centers. As workplaces rapidly evolve,
changes continue to present new health and safety risks to workers,
which need to be addressed promptly through occupational health and
safety research and training.
The 18 university based ERCs provide local, regional, and national
resources for all those in need of occupational health and safety
assistance. Collectively, the ERCs provide graduate- and post-graduate
level education and research training in the occupational health and
safety disciplines. The ERCs prepare a workforce of occupational safety
and health professionals to every Federal Region in the U.S who are
trained to identify and mitigate vulnerabilities from all sources,
including increased readiness to respond to chemical, biological,
radiological, or nuclear attacks. Occupational health and safety
professionals work with emergency response teams to minimize disaster
losses, as exemplified by their lead role in minimizing hazards among
workers involved in clean-up and restoration of the extreme devastation
caused by Hurricanes Harvey, Irma, and Maria in Texas, Florida, Puerto
Rico, and the U.S. Virgin Islands. In 2020, the ERCs responded rapidly
to provide employers across the country with accessible, concise
information on the workplace implications of COVID-19 and are now
providing local and national online and telephonic advising programs
for businesses as they seek to reopen safely.
NIOSH also focuses research and outreach efforts on the nation's
most dangerous worksites that often impact lives in more rural parts of
America. The Centers for AgFF were established by Congress in 1990 (PL
101-517) in response to evidence that agricultural, forestry, and
fishing workers suffer substantially higher rates of occupational
injury and illness than other nation's workers. Agricultural workers
are more than six times more likely to die on the job than the average
worker, averaging 540 fatalities per year, and more than 1 in 100
workers incur nonfatal injuries resulting in lost workdays each year.
Our food security depends on a healthy and safe agricultural
workforce--an essential sector that has been hit particularly hard
during the pandemic. Today, the NIOSH AgFF initiative includes ten
regional Agricultural Centers and one national Children's Farm Safety
and Health Center. The AgFF program is the only substantive federal
effort to ensure safe working conditions in these vital production
sectors. The program also conducts research and outreach to ensure the
safety of our nation's 86,000 workers in forestry and logging, an
industry with a fatality rate more than 30 times higher than that of
all our nation's workers. The AgFF Centers have had a significant
impact on protecting safety and health of agricultural workers. For
example, the developed of rollover protective structures (ROPS or roll
bars) and seatbelts on tractors were shown to prevent 99% of overturn-
related deaths. Partnering with fishing communities, the AgFFs
developed comfortable lifejackets to wear at work, which have increased
chances of survival in the event of a fall overboard. The lifesaving,
cost-effective work of the AgFF program is not replicated by any other
agency. USDA's National Institute of Food and Agriculture interacts
with experts at NIOSH to learn about cutting-edge research and new
directions in this area. In addition, state and federal OSHA personnel
rely on NIOSH research to develop evidence-based standards for
protecting agricultural workers and would not be able to fulfill their
mission without the AgFF program.
NIOSH also supports six TWH Centers of Excellence that conduct
multidisciplinary research and test practical solutions to emerging
challenges that impact the safety, health, well-being, and productivity
of the American workforce. The TWH Centers conduct solutions-focused
research in partnership with employers and employees and partner with
government, business, labor, and community to improve the health and
productivity of the workforce. The TWH Centers' research, education,
and outreach activities occur in workplaces, such as hospitals,
factories, offices, construction sites, and small businesses, resulting
in immediate and measurable improvements in health and safety. These
Centers have been heavily relied upon by employers and employees to
address the impact of the current pandemic not only from an infectious
disease perspective but also to address the impact on mental health,
stress, burnout, and resiliency of essential workers, workers abruptly
working remotely, and those furloughed or laid off. The TWH Centers are
an investment in the American economy, helping valued employees return
home safe and healthy at the end of a productive workday.
We urge you to recognize the critical contribution of NIOSH,
including the ERCs, the AgFF Program, and the TWH Program to the health
and productivity of our nation's workforce. Thank you for the
opportunity to submit testimony.
______
Prepared Statement of Bennett Katherine, MD FACP deg.
Prepared Statement of Katherine Bennett, MD FACP
As the Assistant Director for Education of the Northwest Geriatrics
Workforce Enhancement Center (NW GWEC) at the University of Washington
(UW), immediate past president of the National Association for
Geriatric Education (NAGE), and a current Geriatrics Academic Career
Award recipient, I am pleased to submit this statement for the record
on behalf of myself, the NW GWEC, and NAGE recommending appropriations
of at least $105.7 million in Fiscal Year 2022 to support geriatrics
workforce training under the Geriatrics Workforce Enhancement Program
(GWEP) and the Geriatrics Academic Career Award (GACA) program.
Administered by the Health Resources and Services Administration
(HRSA), both programs reach rural and underserved populations and
address health inequities. We thank you for your past extensive support
of these programs. An appropriation at this level will build upon these
programs that are vital to the health and well-being of our nation's
older adults and those who provide care for them.
We all know that there are many older people in our homes,
communities, and states who need the care of well-trained health
professionals. It turns out that we have much of the know-how,
expertise, curricula, and teachers to offer this training! What we need
from you is the funding to support the dissemination of this expertise
to more health care providers and systems who treat older patients. The
GWEP and the GACA programs are the only federally funded programs
designed to increase the number of health professionals with the skills
and training to provide high quality, patient-centered, equitable,
cost-saving care for older adults. This training is critical to
addressing the suboptimal care that is so frequent and widespread, and
something I see the devastating impacts of each day--older adults who
are prescribed dozens of medications that are contributing to falls and
cognitive impairment; advanced dementia that has gone undiagnosed for
years; and life-altering injuries from falls that could have been
prevented.
Suboptimal healthcare occurs not because primary care teams do not
care but because most providers in practice have received insufficient
and more often no training whatsoever in the core principles of high-
quality care for older adults. In a just society, we aspire to provide
adequate health care at every age and stage of life. The care of older
adults is a unique skill set, largely due to age-related changes to the
entire body, the simultaneous presence of multiple chronic diseases,
and conditions that are unique to older adults--this care really cannot
be done well without specific training. The GWEP and the GACA programs
seek to change the present reality through quality improvement and
education initiatives conducted in partnership with primary care
practices and community agencies, and by training future leaders in
geriatrics care transformation.
There are currently 48 GWEPs, located in 35 states and 2
territories, that are working to rapidly transform and expand the
health care of older adults. The current appropriation level makes it
impossible to have at least one GWEP in every state or for current
GWEPs to have adequate funds to do an expanding body of work. This
increased funding is urgently needed so that these vital programs can
equitably reach all areas of the country and effectively respond to the
rapid growth in number and increasing health complexity of older
adults. These programs are integral to the training, support, and
expansion of the eldercare workforce and long-term services and
supports infrastructure.
The 48 current GWEPs have tremendous impact on their regions.
During 2019-2020, 56,603 health professions trainees participated in
GWEP-led education activities, and 290,161 faculty and providers
attended 2,069 different continuing education events, which included
906 events focused on Alzheimer's disease and other dementias. GWEPs
partner with health systems (including federally qualified health
centers and Veteran's Affairs Medical Centers) and community-based
organizations to have the greatest impact and optimize the community/
health care linkages that are essential to older adults and their
caregivers. Every GWEP is focused on meeting the needs of rural and/or
underserved populations, and GWEPs play an integral role in reducing
health inequities. For example, a GWEP based on the South Side of
Chicago addressed health disparities for African Americans with
dementia by partnering with faith-based community leaders, and another
GWEP partnered with FQHCs to create and distribute multilingual COVID-
19 education materials and increase behavioral health capacity.
Over the past two years, GWEPs have joined forces with the
Institute for Healthcare Improvement and The John A. Hartford
Foundation to drive spread of the Age-Friendly Health System
initiative. This initiative aims to align healthcare with an older
adult's goals by eliciting what matters most to them, ensuring that
medications regimens minimize the risk of harm, optimizing mood and
cognition, and guiding them to move safely and prevent falls. This type
of evidence-based care not only improves outcomes but reduces
healthcare costs. To date, GWEPs are partnering on this initiative with
302 health care delivery sites, 42% of which are in medically
underserved communities and 45% designated as primary care. Nearly
6,000 different activities focused on Age-Friendly Health System
transformation have reached 205,322 individuals.
The COVID-19 pandemic highlighted the fragility of the network of
supports that help keep older adults healthy and thriving in the
community. The GWEPs quickly pivoted to redirect the training of the
healthcare workforce in the face of the obstacles resulting from the
pandemic while continuing to meet the needs of older adults and their
caregivers. For example, our GWEP partnered with Area Agencies on Aging
to provide electronic tablets (along with training and support) and
telehealth stations to keep older adults connected online to essential
primary care services. We also quickly shifted our training to an
entirely virtual format and focused on what interprofessional teams
need to optimally care for older adults during the pandemic. Training
sessions covered COVID-19 in older adults, assessing cognition via
telehealth, addressing goals of care during the pandemic, and screening
for falls via telehealth.
Around the country, GWEPs have done nothing short of amazing work
during COVID-19 by partnering with primary care and community agencies
to meet the medical, behavioral health, social, and basic needs of
older adults and their caregivers. GWEPs addressed social isolation via
virtual connection and phone outreach, trained teams of healthcare
providers in age-friendly telehealth, provided virtual trainings on key
care principles for older adults, delivered virtual caregiver support,
and partnered on rapid vaccine rollout to the most vulnerable in the
community, to name just a few examples. Taken together, the GWEPs
delivered 400 unique training sessions that addressed COVID-19 related
issues and reached over 54,000 individuals. The pandemic demonstrated
the tremendous ability of GWEPs to adapt to unforeseen circumstances
and remain focused on transforming the care of older adults to be age-
friendly and preparing the healthcare workforce to meet the most
pressing needs of older adults and their caregivers.
The Northwest Geriatrics Workforce Enhancement Center (NW GWEC),
UW's GWEP, was established in 2015 and provides training and programs
that enhance the lives of older adults and their caregivers in
Washington and throughout the region. Our programs include Project
ECHO-Geriatrics, a Primary Care Liaison Program based at the Area
Agencies on Aging (AAA), a AAA Practicum for health professions
trainees, and the Geriatrics Healthcare Lecture Series. Here are some
examples of our reach.
--Project ECHO-Geriatrics: NW GWEC's Project ECHO--Geriatrics, or the
Extension for Community Healthcare Outcomes, which is based on
the evidence-based ECHO model that trains and mentors current
and future primary care providers to provide specialty care to
their own patients and reduce health disparities. Sessions
involve virtual mentoring sessions with teaching and
consultations with an interprofessional geriatrics specialist
panel. Since 2016, we have held over 60 monthly sessions with
over 1,000 unique participants. Sessions focus on key primary
care topics such as dementia, fall prevention, and depression.
Dr. Braun, a faculty member at the Providence St. Peter Family
Medicine Residency Program with sites in Olympia and Chehalis,
WA said, ``The program not only helps achieve our hours of
required geriatrics training but has transformed the care I see
provided by our residents in clinic and across healthcare
settings.''
--Primary Care Liaison Program: Our GWEP partnered with several Area
Agencies on Aging in WA to create a Primary Care Liaison (PCL)
program to connect primary care clinics to AAAs through
outreach, engagement, and education as well as facilitating
referrals. This program has increased primary care referrals to
participating AAAs by over 4-fold.
The GACA program aims to train the next generation of leaders in
geriatrics. There are currently 26 GACA awardees across 16 states
representing a range of health professions disciplines (e.g.,
physicians, social workers, dentists, physical therapists). GACA awards
support career development of future educators, leaders, and innovators
in geriatrics and awardees also train interprofessional teams to
provide age-friendly care. For example, as a current GACA awardee, I
partnered with my local Area Agency on Aging (AAA) to create a new
Project ECHO specifically to train AAA case managers in age-friendly
care. The curriculum covers dementia, fall prevention, depression, and
medication safety, and each ECHO session includes consultation on
complex patients. GACA awardees throughout the country are reshaping
the care of older adults through innovative projects such as
redesigning airports to be age-friendly, reducing unsafe opioid
prescribing in nursing homes, and integrating (oft neglected) oral
health into routine primary care.
Although GWEPs are preparing the healthcare workforce to meet the
needs of older adults and their caregivers, not all states are
benefiting: Only 35 states and two territories have a GWEP, and only 16
states have a GACA recipient. Moreover, since renewal of the GWEP
program in 2019, annual funding per GWEP has been reduced by $100,000
compared to the initial award period (2015-2019). An increase in
appropriation is essential to ensure that every state has at least one
GWEP and that GWEP sites can expand their work. Additionally, increased
appropriations can ensure that there are more GACA awardees to meet the
nation's current and future needs for transformative leaders in
geriatric medicine.
In summary, GWEPs and GACAs are essential to ensure that the
healthcare workforce in this country can meet the needs of older
adults. Through our GWEPs, we have developed the knowledge and
expertise to train interprofessional health care teams. Through our
many partnerships and training activities, we have proved integral to
the training and care delivery of the healthcare workforce including
those in the long-term services and supports infrastructure as well as
eldercare workforce infrastructure. I thank you for your consideration
of this request for appropriations and am deeply grateful for your past
support of these programs that are revolutionizing healthcare of older
adults and their caregivers to be age-friendly, high-quality,
equitable, cost-saving, and aligned with their personal goals and
preferences.
______
Prepared Statement of the Beyond AIDS Foundation
Dear Committee Members,
I am writing in support of a FY 2022 budget request for Department
of Health and Human Services (DHHS) to develop a national strategy and
implementation plan for the prevention, control and treatment of Herpes
Simplex Virus, Types 1 and 2 infections.
It is critical for public health and disease control to address
Herpes Simplex Virus (HSV), a lifetime infection that impacts nearly
half of Black women in our country, disproportionately impacts LGBTQ
populations, and is an important driver of the HIV epidemic.
Approximately 40% of new cases of HIV infection have been attributed to
chronic HSV infection. HSV also kills approximately 1,000 infants
annually as a result of neonatal herpes and injures thousands more.
Despite this largely preventable mortality and morbidity, neonatal
herpes is currently not even a national reportable condition.
Additionally, there is a growing body of research indicating that HSV
may be a contributing factor to Alzheimer's Disease, Encephalitis,
Bell's palsy, among other neurodegenerative diseases.
There is currently no organized national strategy to address HSV.
It is often not tracked nor routinely tested for during clinical and
screening visits. And the majority of spread is via asymptomatic
carriers who are in most cases unaware of their infection status. It is
estimated that over 60 million Americans have genital infections with
either HSV-2 or HSV-1, making it among the most prevalent STIs in the
US. We can and should be doing more to stop the spread and provide
better treatment to the nearly 1 in 3 Americans with this chronic
condition.
For the past two decades, I have served as the volunteer Medical
Advisor for the largest in-person herpes support (HELP) groups in the
country (Los Angeles and Orange Counties, San Diego), and since the
COVID-19 pandemic, the online SoCal HELP group. I have been privy to
observe the negative outcome of having non-existent federal HSV
policies and programs. They include severe genital pain syndromes as
well as bouts of depression, anxiety, shame, and loss of self esteem
accompanying these infections. As the former Director of the largest
domestic STD Program (Los Angeles County) in the US for over a decade,
I was and am currently acutely aware of the shortcomings of our HSV
policies, planning and services, and the great need to change our
approach and address this problem.
If we prioritize women's and maternal health, the health of Black,
Hispanic, LGBTQ, indigenous and other at-risk communities, we must
prioritize Herpes Simplex Virus treatment and prevention. If we
prioritize mental health, biomedical research for incurable diseases
such as Alzheimer's or HIV, and dismantling systemic racism in
healthcare, we must also prioritize Herpes Simplex Virus control.
Addressing HSV addresses all of these national priorities and can
improve the health and quality of life, and reduce the economic burden
for millions of Americans.
Sincerely.
[This statement was submitted by Gary A. Richwald, MD, MPH,
President,
Beyond AIDS Foundation.]
______
Prepared Statement of the Big Cities Health Coalition
On behalf of the Big Cities Health Coalition (BCHC), we
respectfully request that the Subcommittee provide the highest possible
funding for the U.S. Centers for Disease Control and Prevention (CDC),
central to protecting the public's health, for Fiscal Year 2022. Key
CDC programmatic priorities of the Coalition and our member health
departments include violence prevention, immunization, public health
preparedness, epidemiology and laboratory capacity, opioid overdose
prevention, and the public health data modernization initiative.
BCHC is comprised of health officials leading 30 of the nation's
largest metropolitan health departments, who together serve nearly 62
million--or one in five--Americans. Our members work every day to keep
their communities as healthy and safe as possible. We thank you for
your continued leadership and support for our nation's public health
workforce and systems during the ongoing COVID-19 pandemic.
As the Subcommittee members recognize, federal funding for CDC and
the programs that support local and state public health departments
have remained largely stagnant. Additional investments through
sustained annual funding is necessary to build public health capacity
for the next pandemic, as well as the everyday population health
programs.
national center for immunization and respiratory diseases
National Immunization Program
We respectfully request $1.1 billion in FY2022 for the National
Immunization Program. The CDC Immunization Program funds 50 states, six
large, BCHC member cities (Chicago, Houston, New York City,
Philadelphia, San Antonio, and Washington, D.C.), and eight territories
for vaccine purchase and immunization program operations. In addition
to the challenges of the COVID-19 pandemic and continuing disease
outbreaks, recent growth of electronic health records and compliance
with associated regulations, new vaccines and school requirements have
increased the complexity of vaccine management. Additional base funding
is needed for each grantee to sustain improvements supported by
emergency funding and maintain sound and efficient immunization
infrastructure. We also ask that the Committee encourage CDC to be as
flexible as possible in coordinating funding and guidance across
immunization program streams as we do COVID vaccinations while still
also carrying out routine immunizations.
national center for emerging and zoonotic infectious disease
Epidemiology and Lab Capacity
We respectfully request $500 million in FY2022 for the Epidemiology
and Lab Capacity (ELC) program, which is a single vehicle for multiple
programmatic initiatives that go to 50 state health departments, six
large, BCHC member cities (Chicago, Houston, Los Angeles County, New
York City, Philadelphia, and Washington, D.C.), Puerto Rico, and the
Republic of Palau. ELC grants strengthen local and state capacity to
contain infectious disease threats by detecting, tracking and
responding in a timely manner, as well as maintaining core capacity as
the nation's public health eyes and ears on the ground. Increased
funding will help build the epidemiology workforce, allowing state and
local health departments to begin to move towards establishing a
minimum epidemiology workforce; to promote and offer training for state
and local epidemiologists; and to monitor needs in state- and/or local-
based epidemiology capacity. ELC dollars sent to the states should be
tracked through existing CDC reporting structures and shared publicly
to ensure funds are also supporting big city epidemiology activities.
public health scientific services
Public Health Data Modernization Initiative (DMI)
We respectfully request $250 million in FY2022 for the DMI that is
working to create modern, interoperable, and real-time public health
data and surveillance systems at the state, local, Tribal, and
territorial levels. These efforts will ensure our public health
officials on the ground are prepared to address any emerging threat to
public health-whether it be COVID-19, measles, a foodborne outbreak
like E. coli, or another crisis. COVID-19 exposed the gaps in our
public health data systems and since then Congress has provided funding
for DMI through the CARES Act and American Rescue Plan Act. These
investments have been critical, but the public health surveillance
systems must live beyond COVID-19 and be ready for any and all future
threats. This requires long-term, sustained investment that is not just
to build capacity at the federal and state level, but also at health
departments in cities and counties across the country.
public health workforce
We respectfully request $160 million in FY2022 for the public
health workforce and career development programs as proposed in the
President's budget. The public health workforce is the backbone of our
nation's governmental public health system at the county, city, state,
and tribal levels. Investments must be made to build back the public
health workforce, as well as attract and retain diverse candidates with
diverse skill sets. These funds support CDC's fellowship and training
programs including the Public Health Associate Program and the Epidemic
Intelligence Service that extend the capacity of health departments and
key partners at all levels of government.
cross-cutting activities and program support
Public Health Infrastructure and Capacity
We respectfully request $400 million in FY2022 for a new Public
Health Infrastructure and Capacity investment as proposed in the
President's budget request. The pandemic exposed the deadly
consequences of chronic underfunding of basic public health capacity.
Because public health is largely funded by disease or condition, there
has been little investment in cross-cutting capabilities that are
critical for effective public health. These capabilities include:
public health assessment; preparedness and response; policy development
and support; communications; community partnership development;
organizational competencies; accountability; and equity. Governmental
public health infrastructure requires sustained investments over time
and we believe this is an important start. This investment is critical
to ensuring that our governmental public health system is prepared for
the next pandemic as well as to strengthen the health of our
communities every day.
national center for injury prevention and control
Opioid Overdose Prevention and Surveillance
We respectfully request $713 million in FY2022 for Opioid Overdose
Prevention and Surveillance in line with the President's request. Many
health departments were forced to curtail opioid and other substance
use disorder services during the pandemic. Unfortunately, overdose
numbers are increasing in many communities, erasing progress of recent
years. Previously, programs that connected with people in hospital
emergency departments after an overdose had seen successful outcomes in
steering people toward syringe services programs and treatment
programs. However, these programs rely on in person interactions that
have been scaled back during the pandemic. Funding is needed in local
communities to ensure that substance use disorder prevention continues
to stem the tide of overdose and death. We also encourage the Committee
to include directive language to insure these dollars reach the local
level in those communities that are not directly funded, as well as
have CDC and the Office of the Assistant Secretary of Health at the
Department of Health and Human Services better track and share publicly
state expenditures.
Gun Violence Prevention Research
We respectfully request $25 million in FY2022 for Gun Violence
Prevention Research and the same as the President's budget request.
Firearm violence is a serious public health problem in the United
States that impacts the health and safety of all Americans. Despite
initial funding in FY 2021 to research key issues around firearm
violence, significant gaps remain in our knowledge about the problem
and ways to prevent it; we need to continue and expand the research.
Addressing these gaps is an important step toward keeping individuals,
families, schools, and communities safe from firearm violence and its
consequences. The public health approach to violence prevention
includes working to define the problem, identifying risk and protective
factors, developing and testing prevention strategies, and then,
assuring widespread adoption of effective, targeted programs.
Additional funds would be used to provide grants to conduct research
into the root causes and prevention of gun violence focusing on those
questions with the greatest potential for public health impact. The
goal of this research is to stem the continued rise of firearm violence
across the country to make our communities safer.
Community Based Violence Intervention Initiative
We respectfully request $100 million in FY2022 for a new Community
Violence Intervention initiative as proposed in the President's budget
request to implement evidence-based community violence interventions
locally. BCHC whole-heartedly supports such an investment. Violence,
like many public health challenges, is preventable. Yet, the majority
of public investments are used to address the aftermath of violence,
too often through systems that can cause further harm. Communities can
be made safer when we understand the events that have led to present
conditions and act on this knowledge by implementing policies and
practices that address the root causes of violence. By making
investments in public health strategies within communities that are
most impacted by violence, cities can work across sectors to shift from
an overreliance on the criminal justice system and move from
reimagining to realizing community safety.
center for preparedness and response
Public Health Emergency Preparedness Cooperative Agreements
We respectfully request $1 billion in FY2022 for the public health
emergency preparedness (PHEP) grant program. PHEP provides funding to
strengthen local and state public health departments' capacity and
capability to effectively respond to public health emergencies,
including terrorist threats, infectious disease outbreaks, natural
disasters, and biological, chemical, nuclear, and radiological
emergencies. PHEP funding has been cut by over 30% in the last decade.
Recent events, such as the response to the COVID-19 pandemic,
demonstrate the need to invest in these programs to rebuild and bolster
our country's public health preparedness and response capabilities.
America's public health preparedness systems are stretched to the brink
and will need increased and stable base funding for years to rebuild
and improve. We also encourage the committee to include directive
language to insure these dollars reach the local level in those
communities that are not directly funded, as well as have CDC and the
Office of the Assistant Secretary of Health at the Department of Health
and Human Services better track and share publicly state expenditures.
national center for chronic disease prevention and health promotion
Social Determinants of Health
We respectfully request $153 million in FY2022 for the Social
Determinants of Health (SDOH) program in line with the President's
request. CDC's SDOH program was initially funded in FY2021 to
coordinate CDC's activities and to begin to provide tools and resources
to public health departments, academic institutions, and nonprofit
organizations to address the social determinants of health in their
communities. Local and state health and community agencies lack funding
and tools to support these cross-sector efforts and are limited in
doing so by disease-specific federal funding. Given appropriate funding
and technical assistance, more communities could engage in
opportunities to address social determinants of health that contribute
to high health care costs and preventable inequities in health
outcomes.
Office of Smoking and Health (OSH)
We respectfully request $310 million in FY2022 for the Office of
Smoking and Health (OSH). Tobacco use has long been the leading
preventable cause of death in the United States. Each year, it kills
more than 480,000 Americans and is responsible for approximately $170
billion in health care costs. OSH has a vital role to play in
addressing this serious public health problem. It provides grants to
states and territories to support tobacco prevention and cessation,
runs a highly successful national media campaign, conducts research and
surveillance on tobacco use, and develops best practices for reducing
it. Additional resources will allow OSH to address the alarmingly high
rates of youth e-cigarette in addition to other forms of tobacco.
______
Prepared Statement of the Campaign for Tobacco-Free Kids
I am Matthew Myers, President of the Campaign for Tobacco-Free
Kids. I am submitting this written testimony for the record to urge the
subcommittee to increase funding by $72.5 million for the Office on
Smoking and Health (OSH) at the Centers for Disease Control and
Prevention (CDC). By providing OSH with a fiscal year 2022 funding
level of $310 million, CDC will be able to more effectively address
high levels of youth e-cigarette use, expand its highly effective Tips
from Former Smokers public education campaign, and aggressively address
the role that tobacco use plays in health disparities by increasing its
efforts to assist populations and regions of the country with
disproportionately high rates of tobacco use and tobacco-related
disease and premature death. Helping tobacco users to quit is of
particular importance at this time given that cigarette smoking
increases the risk of severe illness from COVID-19.\1\
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\1\ CDC, ``People with Certain Medical Conditions,'' accessed April
28, 2021, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-
precautions/people-with-medical-conditions.html.
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Tobacco use remains the leading cause of preventable disease and
death in the United States. More than 480,000 Americans die from
tobacco use each year, and over 16 million Americans are currently
living with a tobacco-caused disease.\2\ Thirty-two percent of heart
disease deaths, 30 percent of all cancer deaths, 87 percent of lung
cancer deaths, and nearly 80 percent of all chronic obstructive
pulmonary disease (COPD) deaths stem from tobacco use.\3\ Smoking
shortens the life of a smoker by more than a decade.\4\
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\2\ U.S. Department of Health and Human Services (HHS), The Health
Consequences of Smoking--50 Years of Progress: A Report of the Surgeon
General, 2014, http://www.surgeongeneral.gov/library/reports/50-years-
ofprogress/.
\3\ HHS, The Health Consequences of Smoking--50 Years of Progress:
A Report of the Surgeon General, 2014; ``Centers for Disease Control
and Prevention (CDC) Vital Signs, Cancer and Tobacco Use, Tobacco Use
Causes Many Cancers,'' November 2016. https://www.cdc.gov/vitalsigns/
pdf/2016-11-vitalsigns.pdf.
\4\ HHS, The Health Consequences of Smoking--50 Years of Progress:
A Report of the Surgeon General, 2014.
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Funding for CDC's Office on Smoking and Health remains modest when
compared to the estimated $226 billion in annual health care costs
attributable to tobacco use.\5\ Even with the funding increases it has
received over the past two years, the Office on Smoking and Health's
resources remain stretched too thin. OSH needs additional resources to
address an epidemic in youth use of e-cigarettes while continuing to
reduce other forms of tobacco use, especially among populations
disproportionately harmed by tobacco products.
---------------------------------------------------------------------------
\5\ Xu, X et al., ``Annual Healthcare Spending Attributable to
Cigarette Smoking in 2014,'' American Journal of Preventive Medicine,
2021.
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High levels of youth e-cigarette use is threatening to undermine
decades of progress in reducing youth tobacco use. E-cigarettes have
been the most popular tobacco product used by kids since 2014.\6\ These
products come in a wide array of flavors that attract youth and often
deliver high levels of nicotine.\7\ In 2020, 3.6 million youth were
current users of e-cigarettes, including nearly 1 in 5 high school
students.\8\ Alarmingly, 38.9 percent of all high school e-cigarette
users used e-cigarettes for 20 days or more a month, an indicator of
addiction.\9\ In addition to exposing users to nicotine and other
harmful and potentially harmful substances, research shows that e-
cigarette use increases the risk of smoking cigarettes.\10\
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\6\ Wang, TW, et al., ``E-cigarette Use Among Middle and High
School Students--United States, 2020,'' MMWR, Volume 69, September 9,
2020, https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6937e1-H.pdf;
Gentzke, A., et al., ``Vital Signs: Tobacco Product Use Among Middle
and High School Students--United States, 2011-2018, MMWR, Vol. 68, No.
6, February 2019. https://www.cdc.gov/mmwr/volumes/68/wr/pdfs/mm6806e1-
H.pdf.
\7\ Office of the Surgeon General, ``Surgeon General's Advisory on
E-Cigarette Use Among Youth,'' December 18, 2018, https://e-
cigarettes.surgeongeneral.gov/documents/surgeon-generals-advisory-on-e-
cigarette-use-among-youth-2018.pdf.
\8\ Wang, TW, et al., ``E-cigarette Use Among Middle and High
School Students--United States, 2020,'' MMWR, Volume 69, September 9,
2020, https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6937e1-H.pdf.
\9\ Wang, TW, et al., ``E-cigarette Use Among Middle and High
School Students--United States, 2020,'' MMWR, Volume 69, September 9,
2020, https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6937e1-H.pdf.
\10\ HHS, E-Cigarette Use Among Youth and Young Adults. A Report of
the Surgeon General. Atlanta, GA: U.S. Department of Health and Human
Services, Centers for Disease Control and Prevention, National Center
for Chronic Disease Prevention and Health Promotion, Office on Smoking
and Health, 2016; Barrington-Trimis, JL, et al., ``E-Cigarettes and
Future Cigarette Use,'' Pediatrics, 138(1), published online July 2016;
National Academies of Sciences, Engineering, and Medicine. 2018. Public
health consequences of e-cigarettes. Washington, DC: The National
Academies Press. http://nationalacademies.org/hmd/Reports/2018/public-
health-consequences-of-e-cigarettes.aspx. Berry, KM, et al.,
``Association of Electronic Cigarette Use with Subsequent Initiation of
Tobacco Cigarettes in US Youths,'' JAMA Network Open, 2(2), published
online February 1, 2019;.
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The CDC's Office on Smoking and Health has a critical role to play
in addressing the youth e-cigarette epidemic. The agency has extensive
experience working with state and local health departments and the
capacity to identify and implement effective prevention strategies
designed specifically towards youth. An increase in funds would allow
CDC to provide more resources to state and local health departments;
educate students, parents and their communities about the risks of
youth e-cigarette use; and develop and implement other strategies to
protect kids.
In addition to the youth e-cigarette epidemic, there remains a
great need to help adult tobacco users who want to quit. The vast
majority of adult smokers started as youth, want to quit and wish they
had never started.\11\ The CDC's national media campaign, Tips from
Former Smokers (Tips), has proven to be highly successful at helping
smokers quit. The campaign features former smokers discussing the harsh
realities of living with a disease caused by smoking and how current
smokers can access evidence-based resources to assist them in quitting.
Between 2012 and 2018, the campaign motivated over 16.4 million smokers
to make a quit attempt and helped over one million smokers to
successfully quit for good.\12\ A recent cost-effectiveness analysis
found that over the same timeframe, Tips helped prevent 129,100
smoking-related deaths and saved an estimated $7.3 billion in smoking-
related health care costs.\13\
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\11\ U.S. Department of Health and Human Services (HHS), The Health
Consequences of Smoking--50 Years of Progress: A Report of the Surgeon
General, 2014; Babb, S., et al., ``Quitting Smoking Among Adults--
United States, 2000-2015,'' MMWR 65(52), January 6, 2017;Nayak, P., et
al., ``Regretting Ever Starting to Smoke: Results from a 2014 National
Survey,'' International Journal of Environmental Research and Public
Health, 2017; O'Connor, Richard J., et al., ``Exploring relationships
among experience of regret, delay discounting, and worries about future
effects of smoking among current smokers.'' Substance Use & Misuse 51,
no. 9 (2016).
\12\ Murphy-Hoefer R, Davis KC, King BA, Beistle D, Rodes R,
Graffunder C. Association between the Tips From Former Smokers Campaign
and Smoking Cessation Among Adults, United States, 2012-2018.
Preventing Chronic Disease, 2020.
\13\ Shrestha SS, est al., ``Cost Effectiveness of the Tips From
Former Smokers Campaign--US, 2012-2018. American Journal of Preventive
Medicine, December 2020.
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The Tips campaign has been enormously successful despite being on
air for only part of the year. In 2020, the campaign ran for 28 weeks.
The 2014 Surgeon General's Report, The Health Consequences of Smoking-
50 Years of Progress, said that media campaigns like Tips would ideally
run 12 months a year.\14\ With additional funding, the CDC could extend
the number of weeks the campaign is on the air as well as the frequency
with which the ads are run. Research has demonstrated that increased
exposure to Tips ads leads to increases in intentions to quit and quit
attempts.\15\
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\14\ U.S. Department of Health and Human Services (HHS), The Health
Consequences of Smoking--50 Years of Progress: A Report of the Surgeon
General, 2014, http://www.surgeongeneral.gov/library/reports/50-years-
ofprogress/.
\15\ Davis, Kevin C., et al. ``Association Between Media Doses of
the Tips From Former Smokers Campaign and Cessation Behaviors and
Intentions to Quit Among Cigarette Smokers, 2012-2015.'' Health
Education & Behavior (2017).
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Tobacco use plays a significant role in health disparities. Despite
the progress that has been made in reducing tobacco use, certain
populations and regions of the country face disproportionately high
rates of tobacco use and tobacco-related disease and premature death.
For example, Americans with lower levels of education and income,
American Indians and Alaska Natives, lesbian, gay and bisexual adults,
and adults with a mental illness all smoke at significantly higher
rates than other Americans.\16\ Despite initiating smoking later in
life than whites, Black Americans suffer from significantly higher
rates of diseases and death caused by smoking.\17\
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\16\ Cornelius ME, Wang TW, Jamal A, Loretan CG, Neff LJ. Tobacco
Product Use Among Adults--United States, 2019. MMWR Morb Mortal Wkly
Rep 2020;69:1736-1742. DOI: http://dx.doi.org/10.15585/mmwr.mm6946a4;
Substance Abuse and Mental Health Services Administration (SAMHSA),
HHS, Results from the 2019 National Survey on Drug Use and Health,
NSDUH: Detailed Tables, 2019, https://www.samhsa.gov/data/report/2019-
nsduh-detailed-tables.
\17\ Roberts, ME, et al., ``Understanding tobacco use onset among
African Americans,'' Nicotine & Tobacco Research, 18(S1): S49-S56,
2016; Alexander, LA, et al., ``Why we must continue to investigate
menthol's role in the African American smoking paradox,'' Nicotine &
Tobacco Research, 18(S1): S91-S101, 2016; CDC, ``Quitting Smoking Among
Adults-United States, 2000-2015,'' MMWR, 65(52): 1457-1464, January 6,
2017, https://www.cdc.gov/mmwr/volumes/65/wr/pdfs/mm6552a1.pdf; HHS,
``Tobacco Use Among US Racial/Ethnic Minority Groups-African Americans,
American Indians and Alaskan Natives, Asian Americans and Pacific
Islanders, and Hispanics: A Report of the Surgeon General,'' 1998,
http://www.cdc.gov/tobacco/data_statistics/sgr/1998/complete_report/
pdfs/complete_report.pdf.
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With additional funding, CDC could provide targeted assistance to
groups disproportionately harmed by tobacco use. By collaborating with
state and local health departments and community organizations, CDC
could implement prevention and cessation programs tailored to resonate
with and serve specific groups.
We urge the subcommittee to increase funding for CDC's Office on
Smoking and Health from the $237.5 million it received in fiscal year
2021 to $310 million in fiscal year 2022. An additional $72.5 million
would provide CDC with the resources it needs to increase funding to
states and take other steps to address the epidemic of youth e-
cigarette use, expand the highly successful Tips from Former Smokers
media campaign, and provide targeted assistance to groups
disproportionately harmed by tobacco use.
We appreciate the opportunity to highlight the important work of
CDC's Office on Smoking and Health and the need to increase its funding
to $310 million in fiscal year 2022.
[This statement was submitted by Matthew L. Myers, President,
Campaign for Tobacco-Free Kids.]
______
Prepared Statement of the Caregiver Action Network
On behalf of Caregiver Action Network (CAN), I am testifying in
support of the Care Corps program funded through HHS' Administration
for Community Living (ACL). We request doubling the appropriation for
Care Corps from $4 million in FY 2021 to $8 million in FY 2022.
Care Corps is an innovative Federally funded grant program that was
created in FY 2019 with a $5 million appropriation, subsequently
receiving $4 million in FY 2021. In August 2019, the U.S.
Administration for Community Living (ACL) awarded a five-year
cooperative agreement to implement the new Care Corps program to a team
of four organizations comprised of Oasis Institute, Caregiver Action
Network, the National Association for Area Agencies on Aging, and
Altarum. The four organizations named the new program the Community
Care Corps.
Community Care Corps fosters innovative local models to provide
volunteer non-medical assistance to family caregivers, older adults,
and adults with disabilities. Community Care Corps is an opportunity
for community organizations to use volunteers to address some of the
gaps in existing basic supports for family caregivers, older adults,
and people with disabilities. The program, intended as a demonstration
program over 5 years, will also evaluate the effectiveness of local
models in different communities nationally.
For tens of millions of Americans who are older, frail, or
functionally disabled, timely access to reliable assistance with simple
household tasks and meaningful companionship can make an enormous
difference in the quality of their lives and their ability to sustain
meaningful, ongoing connections to the community in which they live.
Today, 80% of the care for those over age 65 is provided by family
caregivers. Yet in the future there will be fewer caregivers. According
to AARP, in 2010, there were more than 7 potential caregivers for every
person over age 80. By 2030, the caregiver ratio will drop to 4 to 1;
and by 2050, the ratio drops to less than 3 to 1. During this same
period, the number of individuals over the age of 84 is set to rise by
350%.
Given the rapidly shrinking ratio of family caregivers to the
number of older Americans who need assistance, volunteers aged 18 and
older can help ameliorate the coming ``caregiving cliff'' brought on by
the nation's demographic changes. In support of the Care Corps program,
the Report accompanying the House Labor-HHS Appropriations bill last
year ``recognize[d] the growing demand for services and supports to
help seniors and individuals with disabilities live independently in
their homes, and the need to support family caregivers who facilitate
that independence.''
Interest in the new Community Care Corps program across the country
has been tremendous. Community Care Corps issued its first RFP in 2020
and received 183 applications from 45 states plus DC and Puerto Rico.
The application process was very competitive, with the 183 applications
totaling $23 million in funding requests. Clearly, not all applications
received funding (we were only able to fund 10% of the grant requests);
and those that did, did not receive the full amount requested.
We selected 23 grantees from 20 states from this competitive pool
of applications. The award amounts range in size from $30,000--
$250,000. The 23 grantees' local model volunteer programs are
community-based and provide a wide range of non-medical volunteer
services. Community Care Corps volunteer programs do not replace the
important services that the home care workforce and other paid
professionals provide to help individuals live independently in the
community.
Our 2020 grantees represent a diverse cross section of the nation,
representing urban, rural, Frontier and Tribal communities. The
grantees comprise numerous types of organizations including community-
based organizations, university-based clinics, area agencies on aging,
neighborhood villages, government agencies, coalitions, hospitals, and
social service organizations. The size of the organizations also varies
considerably--from very large such as Maryland's St. Agnes Hospital, a
member of Ascension Health, the largest non-profit health care
organization in the nation, to North Carolina's Carova Beach Volunteer
Fire and Rescue Auxiliary with a volunteer staff of one serving a small
ocean front community that can only be accessed by four-wheel-drive.
Grantees provide services to individuals of a variety of races and
ethnicities including Hispanic, Native American, White, Black, Asian,
and Native Alaskan. Two grantees specifically serve new Americans.
We particularly search for local grantees with innovative ways to
use volunteers to provide non-medical assistance in their community.
For example, in Alaska volunteers assisted the target population with
fishing and hunting to supplement food sources. The grantee in Michigan
leveraged face-to-face video calls to participants even prior to the
COVID crisis. In Connecticut, the grantee exercised flexibility by
using their Trusted Ride Transportation program to pivot and provide
COVID vaccine appointments and transportation for older adults in need
of the vaccine.
In the first six months--even with time needed to adapt their
original plans to the then-emerging Covid pandemic that required
changes in how they deliver volunteer services--the grantees have
already served 2,744 people. That included:
--2,273 older adults
--162 adults with disabilities
--309 family caregivers
Also, during the first six months, more than a thousand volunteers
provided non-medical services and 191 training sessions were held for
these volunteers.
Over the five years of the Community Care Corps program, local
models with the most promising results, most effective and efficient
outputs and outcomes, and greatest positive ROI will be assessed as
ideal candidates for broader dissemination. Several outcomes and
outputs are measured on a quarterly basis.
We are now about to begin the second grant cycle. The Senate
Appropriations Labor/HHS Subcommittee included $4 million for Community
Care Corps in FY 2021 and that was the level that was enacted for FY
2021. With the $4 million appropriated, we are able to fund additional
grants and look forward to getting applications for innovative
volunteer models from local communities across the country. The RFP for
new applications has just been released and applications will be
accepted through July 9. In addition, current grantees can apply for
second-year funds. One of the key enhancements to our 2021 RFP is an
intensified focus on diversity of volunteers, communities served, and
caregivers in both the application and review process.
Caregiver Action Network (CAN) is the nation's leading non-profit
family caregiver organization providing education, peer support, and
resources to family caregivers across the country free of charge. One
of the many things CAN does for Community Care Corps is to provide a
wide range of communication and outreach support. CAN works with the
grantees to capture videos of the experiences of care recipients,
family caregivers, and volunteers to amplify their collective voices
through stories. These videos provide a true and authentic voice that
increases awareness about the impact of grantee local models on their
communities. As of this reporting period, grantees have generated more
than 30 videos of volunteers, care recipients, family caregivers, and
staff that have been shared on social media, with local media outlets,
and with elected officials.
The first grant cycle of the Community Care Corps has been
extremely successful. With the tremendous interest in the program and
the large number of worthy applications from communities across the
country, we request doubling the appropriation for Care Corps to $8
million in FY 2022 from the $4 million level in FY 2021 (and the $5
million level in FY 2019). This will allow the program to fund more
local volunteer services and make up for the gap in funding that
occurred in FY 2020. Thank you.
[This statement was submitted by John Schall, Chief Executive
Officer, Caregiver Action Network.]
______
Prepared Statement of the CDC Coalition
The CDC Coalition is a nonpartisan coalition of organizations
committed to strengthening our nation's prevention programs. We
represent millions of public health workers, clinicians, researchers,
educators and citizens served by CDC programs. We believe Congress
should support CDC as an agency, not just its individual programs. We
urge a funding level of at least $10 billion for CDC's programs in FY
2022 to help ensure the agency has adequate resources for its many
important programs to improve the public's health. We appreciate the
increases provided for CDC in FY 2021 and we are grateful for the
emergency supplemental funding provided for CDC to address COVID-19. We
urge Congress to continue efforts to build upon these investments to
strengthen all of CDC's programs. We strongly support the increases for
important CDC programs outlined in President Biden's FY 2022 budget
request and urge the committee to support these and other needed
funding increases for CDC programs.
CDC serves as the command center for the nation's public health
defense system against emerging and reemerging infectious diseases.
From aiding in the surveillance, detection and prevention of the
current COVID-19 outbreak globally and in the U.S. to playing a lead
role in the control of Ebola in West Africa and the Democratic Republic
of the Congo, to monitoring and investigating disease outbreaks in the
U.S., to pandemic flu preparedness to combating antimicrobial
resistance, CDC is the nation's--and the world's--expert resource and
response center, coordinating communications and action and serving as
the laboratory reference center for identifying, testing and
characterizing potential agents of biological, chemical and
radiological terrorism, emerging infectious diseases and other public
health emergencies.
CDC serves as the lead agency for bioterrorism and public health
emergency preparedness and response programs and must receive sustained
support for these critical programs. We urge you to provide adequate
funding for the Public Health Emergency Preparedness grants which
provide resources to our state and local health departments to help
them protect communities in the face of public health emergencies. We
also urge you to provide adequate funding for CDC's infectious disease,
laboratory and disease detection capabilities to ensure we are prepared
to tackle both ongoing COVID-19 pandemic and other public health
challenges and emergencies that will likely arise during the coming
fiscal year. Additionally, your continued support for CDC's public
health Data Modernization Initiative is critical to ensuring we have
both the world-class data workforce and data systems that are ready for
the next public health emergency.
We strongly support the president's budget request for $400 million
in new funding to bolster core public health infrastructure and
capacity at the federal, state, territorial and local levels. This
flexible funding is critical to addressing the gaps in core public
health infrastructure and capacity at all levels as well as ensuring
our nation's health departments are able to attract and retain
experienced leaders and respond to future public health emergencies and
disease outbreaks. Sustained, flexible funding is critical to
rebuilding and strengthening the nation's public health system.
Injuries are the leading causes of death for people ages 1-44.
Unintentional and violence-related injuries, such as older adult falls,
firearm injury, child maltreatment and sexual violence, account for
nearly 27 million emergency department visits each year. In 2013,
injury and violence cost the U.S. $671 billion in direct and indirect
medical costs. In 2019, opioids killed nearly 50,000 individuals
nationwide. CDC provides states with resources for opioid overdose
prevention programs and to ensure that health providers to have
information to improve opioid prescribing and prevent addiction and
abuse. In 2019, there were over 39,707 U.S. firearm-related fatalities.
We thank Congress for providing CDC with dedicated funding for firearm
morbidity and mortality prevention research and we strongly urge you to
support the president's request to double this funding in FY 2022. All
programs within the National Center for Injury Prevention and Control
must be adequately funded to conduct research, prevent injuries, and
help save lives.
In 2019, 659,041 people in the U.S. died from heart disease, the
nation's number one cause of death, accounting for about 23% of all
U.S. deaths. More males than females died of heart disease in 2019,
while more females than males died of stroke that year. Stroke is the
fifth leading cause of death and is a leading cause of disability. In
2019, 150,005 people died of stroke, accounting for about one of every
19 deaths. Annually, heart disease and stroke cost the U.S. an
estimated $363.4 billion in health care and lost productivity. CDC's
Heart Disease and Stroke Prevention Program; WISEWOMAN; and Million
Hearts improve cardiovascular health and we urge you to provide
adequate funding for these important lifesaving programs.
More than 1.9 million new cancer cases and over 600,000 deaths from
cancer are expected in 2021. The amount spent on cancer related
healthcare is expected to grow from $183 billion in 2015 to $246
billion in 2030--an increase of 34%. The National Breast and Cervical
Cancer Early Detection Program helps millions of low-income, uninsured
and medically underserved women gain access to lifesaving breast and
cervical cancer screenings and provides a gateway to treatment upon
diagnosis. The Colorectal Cancer Control Program improves screening
rates among targeted, low-income populations aged 50-75 years in
targeted states and territories through evidence-based interventions.
CDC funds all 50 states, DC, 7 tribes and tribal organizations and 7
U.S. territories and Pacific Island jurisdictions to develop
comprehensive cancer control plans to address each state's particular
needs. We urge Congress to adequately support these critical programs.
Cigarette smoking causes more than 480,000 deaths each year. CDC's
Office of Smoking and Health funds important programs and education
campaigns such as the Tips From Former Smokers campaign which has
already helped more nearly one million individuals quit smoking and
millions more to make a serious quit attempt. Congress must continue to
support these and other programs to reduce the enormous health and
economic costs of tobacco use in the U.S.
Of the more than 34 million Americans living with diabetes, more
than 7 million cases are undiagnosed. Diabetes is the leading cause of
kidney failure, nontraumatic lower-limb amputations, and new cases of
blindness among adults in the U.S. and the total direct and indirect
costs associated with diabetes were $327 billion in 2017. We urge you
to provide adequate resources for CDC's Division of Diabetes
Translation and the National Diabetes Prevention Program which fund
critical diabetes prevention, surveillance and control programs.
Obesity prevalence in the U.S. remains high. More than 42% of
adults are obese and 19.3% of children ages of 2 to 19 are obese.
Obesity, diet and inactivity are cross-cutting risk factors that
contribute significantly to heart disease, cancer, stroke and diabetes.
The Division of Nutrition, Physical Activity and Obesity funds programs
to encourage the consumption of fruits and vegetables, encourage
sufficient exercise and develop other habits of healthy nutrition and
physical activity and must be adequately funded.
CDC provides national leadership in helping control the HIV
epidemic by working with community, state, national, and international
partners in surveillance, research, prevention and evaluation
activities. CDC estimates that about 1.2 million Americans are living
with HIV with 14% undiagnosed. Prevention of HIV transmission is the
best defense against the AIDS epidemic. Sexually transmitted diseases
continue to be a significant public health problem in the U.S. Nearly
26 million new infections occurred in 2018. STDs, including HIV, cost
the U.S. healthcare system almost $16 billion annually in direct
lifetime medical costs.
The National Center for Health Statistics collects data on chronic
disease prevalence, health disparities, emergency room use, teen
pregnancy, infant mortality and causes of death. The health data
collected through the Behavioral Risk Factor Surveillance System, Youth
Risk Behavior Survey, Youth Tobacco Survey, National Vital Statistics
System, and National Health and Nutrition Examination Survey must be
adequately funded.
CDC's REACH program helps communities address serious disparities
in infant mortality, breast and cervical cancer, cardiovascular
disease, diabetes, HIV/AIDS and immunizations by supporting community-
based interventions and we urge the committee to provide continued
funding for these important activities.
We thank the committee for its initial investment in CDC's Social
Determinants of Health program and urge you to build upon this
investment by increasing funding for the program to ensure that public
health departments, academic institutions and nonprofit organizations
are supported to address the social determinants of health in their
communities that contribute to high health care costs and preventable
inequities in health outcomes. We urge you to support the president's
request of $153 million for this important program.
CDC oversees immunization programs for children, adolescents and
adults, and is a global partner in the ongoing effort to eradicate
polio worldwide. Childhood immunizations provide one of the best
returns on investment of any public health program. For every dollar
spent on childhood vaccines to prevent thirteen diseases, more than $10
is saved in direct and indirect costs. Over the past 20 years, CDC
estimates childhood immunizations have prevented 732,000 deaths and 322
million illnesses. We urge you to provide adequate funding for the
Section 317 Immunization program and other efforts to prevent vaccine-
preventable disease.
Birth defects affect one in 33 babies and are a leading cause of
infant death in the U.S. Children with birth defects that survive often
experience lifelong physical and mental disabilities. Approximately one
in six U.S. children is living with at least one developmental
disability and one in four adults live with a disability. The National
Center on Birth Defects and Developmental Disabilities conducts
programs to prevent birth defects and developmental disabilities and
promote the health of people living with disabilities and blood
disorders.
CDC's National Center for Environmental Health funds programs to
control asthma, protect from threats associated with natural disasters
and climate change and reduce, monitor and track exposure to lead and
other environmental health hazards. Increased funding for all NCEH
programs is critical to protecting the public from environmental health
hazards and reducing illness, disease, injury and even death.
To meet the many ongoing public health challenges facing the
nation, including those outlined above, we urge you to provide at least
$10 billion for CDC's programs in FY 2022.
[This statement was submitted by Don Hoppert, Director of
Government
Relations, American Public Health Association.]
______
Prepared Statement of the Centers for Disease Control and Prevention
Chairwoman Murray, Ranking Member Blunt, and distinguished members
of the Committee, it is an honor to appear before you today to discuss
how investments in the Centers for Disease Control and Prevention (CDC)
are protecting American's health, now and in the future. I am grateful
for this opportunity to address this committee, as well as for your
long-standing and consistent leadership on issues of critical
importance to the health of Americans, and the world.
It is my privilege to represent CDC at this hearing. CDC is
America's health protection agency. For 75 years, CDC has been trusted
to carry out its mission to protect America's safety, health, and
security. Even during the unprecedented circumstances of the past year,
CDC's scientific expertise, determination, selflessness, and innovation
has helped the agency continue to advance its mission. We work 24/7 to
prevent illness, save lives, and protect America from threats to our
health, safety, and security. Addressing infectious diseases and
pandemics, like COVID-19, is central to our mission. CDC's expertise
lies in our ability to study emerging pathogens like SARS-CoV-2, to
understand how they are transmitted, and to translate that knowledge
into timely action to protect the public's health. CDC identifies and
mitigates other causes of morbidity and mortality beyond infectious
diseases, such as environmental and workplace hazards and intentional
and unintentional injuries (such as those from falls, violence, or
overdose). CDC promotes healthy behaviors, such as exercise and
nutrition, to prevent chronic diseases such as diabetes and heart
disease, and to prevent outcomes such as stroke. We promote healthy
communities by increasing access to nutritious food and safe walking
and green space. By deploying experts on the ground to support our
state, Tribal, local, territorial and global partners, we translate
science into implementing guidance that protects individuals,
communities, and populations. In our work with other Federal agencies
we ensure the safe and appropriate use of medical countermeasures,
including vaccines, and collaborate with the academic and private
sector to further our understanding of new diseases and problems that
affect health.
The COVID-19 pandemic threw the United States and the world into a
health, economic, and humanitarian crisis. As the crisis unfolded, it
put a spotlight on pre-existing weaknesses and gaps that threaten the
health of Americans. It brought into stark light the great disparities
in health outcomes by race and ethnicity. We must acknowledge the long-
standing and too often unstated impact that racism has on public
health. The pandemic has also highlighted our frail public health
infrastructure, and the way that frailty impacted our ability to
respond at the necessary scale and speed.
Experts had warned for years that a pandemic of this scale was
coming. Today, we know to expect additional novel and currently rare
diseases to emerge and gain footing as a result of our changing
climate, closer interaction with animals, and globalization. Over the
last 12 years, the United States has faced four significant emerging
infectious disease threats--the H1N1 influenza pandemic, Ebola, Zika,
and COVID-19. These experiences show that public health emergencies
and, specifically, infectious disease threats, are here to stay. While
urgency demanded rapid and unique responses to each of these threats,
none resulted in the sustained improvements needed in our nation's
public health infrastructure. This lack of robust public health
infrastructure continues to present significant challenges in our
ongoing fight against COVID-19. In fact, emergencies have resulted in
the rapid build-up of infrastructure needed to address the emergency,
then dissolution of that infrastructure, often leaving no sustainable
infrastructure in place to address the next threat. This lack of robust
public health infrastructure continues to present significant
challenges in our ongoing fight to tackle COVID-19.
World-wide, billions of people do not and will not have immediate
access to COVID-19 vaccines. Cases will continue to increase, and
variant COVID-19 strains are likely to emerge, persist, and cause
outbreaks. As this becomes more common, our public health system at
home and abroad must be ready with highly sophisticated detection and
sequencing, combined with a rapid response at the source. The
unprecedented investments provided to CDC through COVID-19 supplemental
appropriations have helped our efforts to control COVID-19, and will
also go a long way toward addressing deficits in the core components of
the public health infrastructure that has long been ignored. Our
ability to respond to the next public health crisis will depend on
whether we invest in a public health system that is highly functional
on a day-to-day basis and pivots to meet new threats, rather than
continue our partial defense, which ramps up in response to an urgent
and often short-term event.
A resilient public health system can be realized with careful
planning that builds on the gains made with COVID-19 emergency
supplementals and incorporates lessons learned as a result of this
crisis, including reliable, flexible funding. The FY 2022 Discretionary
Budget Request for CDC and ATSDR includes a total funding request of
$8.7 billion, an increase of $1.6 billion over FY 2021 Enacted. This is
the largest increase in budget authority for CDC in nearly two decades
and defends Americans' health in four ways: (1) building public health
infrastructure, (2) reducing health disparities, (3) using public
health approaches to reduce violence, and (4) defeating other diseases
and epidemics.
First, building the public health infrastructure. CDC's FY 2022
request prioritizes foundational funding to rebuild the public health
infrastructure needed to safeguard the Nation's health and economic
security. Drawing on lessons learned, as well as the latest information
and technologies, CDC will begin to address long-standing
vulnerabilities in the U.S. public health network by training a larger
cadre of experts who can deploy and support public health efforts, and
building capacity to detect and respond to emerging global biological
threats.
Public health action is driven by data. Earlier improvements in our
systems for collecting information after other public health
emergencies, including Ebola and EVALI, facilitated exchange of health
information, linking local, state, and federal public health systems
with healthcare systems and the public. With investments in public
health data modernization in the FYs 2020 and 2021 appropriations and
the COVID-19 supplementals, CDC increased the scale and speed of these
systems during the COVID-19 response to protect people who are at risk
for severe illness (such as older Americans), those with chronic
medical conditions, and those from racial and ethnic minorities. These
advancements must be applied across the public health system and at all
levels of government. The funds requested in FY 2022 will be used to
continue building a modern disease surveillance system at CDC, which
will catalyze a multi-sectoral, comprehensive, and cohesive approach to
documenting evidence, using state-of-the-art technology and analytical
tools. CDC will continue working diligently to ensure its research and
data are of the highest quality and are disseminated nationally to
inform decision-making throughout the public health system, while
supporting advances in data systems at all levels.
The COVID-19 pandemic made clear the role that CDC labs and public
health labs across the nation play in conducting critical surveillance
and responding to outbreaks and emerging threats. CDC and state
laboratories were required to flex and surge during peak periods of
illness, far beyond routine clinical testing. In FY 2019, CDC was only
able to meet 50% of state and local health departments' stated needs
for epidemiology and laboratory capacity funding, with personnel
support being the biggest unfunded need, followed by equipment and
supplies. The FY 2022 request will foster innovation, collaboration
with the clinical system, and a commitment to quality. Improving
technologies at the state and local levels would enable public health
labs to quickly utilize and scale up essential laboratory analyses. In
a post-COVID-19 world, investments to maintain and improve laboratories
will help prevent the failures we experienced while trying to address
COVID-19.
The U.S. needs a workforce of qualified public health professionals
who will prepare for, respond to, and prevent public health crises.
Physicians working for states often earn less than $150,000 per year.
This is after having taken on medical school debt of $200,000 on
average. The FY 2022 request includes an increase to build a diverse
and culturally competent workforce who can rapidly develop innovative
approaches in surveillance and detection, risk communications,
laboratory science, data systems, and disease containment. With this
funding, CDC will support critical training programs for public health
professionals that develop strategic and systems thinking, data
science, communication, and policy evaluation. Existing cooperative
agreement mechanisms will be leveraged to support public health jobs
that meet current needs and attract new personnel to work in
underserved and rural areas.
Addressing gaps in capacity across levels of government to detect
and respond to outbreaks while maintaining and surging in other problem
areas requires investments to be disease-agnostic and flexible. With FY
2022 funding, CDC will provide support to health departments to meet
national quality standards, conduct performance improvement activities,
increase communication and collaboration across the public health
system, and reshape health departments to meet changing conditions and
needs. Funding will help health departments strengthen their abilities
to effectively respond to a range of public health threats, such as
COVID-19, and build capacities that do not currently exist.
COVID-19 is a sobering reminder that a disease threat anywhere is a
disease threat everywhere. Or as stated by WHO: no one is safe unless
everyone is safe. We cannot adequately protect American lives and the
U.S. economy without addressing global disease threats wherever they
may arise. CDC's strategic investments in global health security are
critical to U.S. health security by building sustainable global
capacity to prevent, detect, and respond to emerging infectious disease
threats. CDC works in more than 60 countries on more than 150 projects
and is a key implementing agency for the U.S. Government's leadership
role in the Global Health Security Agenda. With additional resources
requested in FY 2022, CDC will build on existing partnerships with
Ministries of Health, public health agencies, infectious disease
research institutions, and international organizations to strengthen
global laboratory capacity for early disease detection, enhance disease
surveillance for accurate data to drive decision making, and foster
effective regional and global coordination.
Next, I'd like to talk about reducing health disparities. The
disparities seen over the past year among communities of color were not
a result of COVID-19. In fact, the pandemic illuminated inequities that
have existed for generations and revealed a known, unaddressed, and
serious public health threat: racism. The well-being of our entire
nation will be compromised as long as we fail to address this.
Racism is not just discrimination against one group based on the
color of their skin or their race or ethnicity, but the structural
barriers that impact racial and ethnic groups differently to influence
where a person lives, where they work, where their children play, and
where they worship and gather in community. The social determinants of
health (SDOH)-such as high-quality education, stable and fulfilling
employment opportunities, safe and affordable housing, access to
healthful foods, commercial tobacco-free policies, and safe green
spaces for physical activity-are critical drivers of health inequities
in this country. CDC is building the evidence-base for collaborative
approaches to SDOH through community accelerator planning and expanding
a network of community health workers to develop a sustainable
infrastructure to improve health equity. CDC's FY 2022 budget request
includes an increase of $150 million to use a social determinants of
health approach to improve health equity and health disparities in
racial and ethnic minority communities and other disproportionately
affected communities around the country.
This budget directly responds to health disparities recorded in our
public health data. For example, about 700 women die each year in the
U.S. as a result of pregnancy or delivery complications, and American
Indian, Alaska Native, and Black women are two to three times more
likely to die than White women. Data show that about 2/3 of these
deaths may be preventable. Children from lower-income and racial and
ethnic minority households experience a disparate, increased risk for
lead exposure.
Achieving health equity is central to addressing the HIV epidemic.
The U.S. Government spends $20 billion per year in direct health
expenditures for HIV care and treatment. An estimated 1.2 million
persons have HIV and approximately 15% are unaware they have it. With
recent advancements in antiretroviral therapy and biomedical
advancements in HIV prevention, such as pre-exposure prophylaxis
(PrEP), along with effective care and treatment, we have the tools to
end the HIV epidemic. An increased investment requested in FY 2022 for
the Ending the HIV Epidemic (EHE) initiative will enable CDC to advance
the four key strategies needed to end the epidemic in the 57 EHE focus
jurisdictions. In addition, CDC will address health equity in the
entire HIV prevention portfolio, test innovation in service delivery
models to increase access to prevention services, use syndemic
approaches to broaden reach to key populations and create efficiencies,
and strengthen engagement of grassroots community-based organizations
in implementing EHE initiative.
Third, the budget request also addresses the public health epidemic
of violence. We know too well how this epidemic permanently alters the
lives of its victims and their families and puts enormous strain on our
communities and local economies. Increases in CDC's FY 2022 budget
request will help address violence through public health approaches,
which include improving reporting systems that provide the data needed
to understand and address violent deaths and injuries in the United
States.
And fourth, we must defeat other diseases and epidemics. Just as
racism underlies a number of public health issues, climate issues
underlie a number of infectious diseases and have significant health
impacts. Climate changes are associated with changes in the
geographical range of mosquitos, ticks, and other disease vectors.
Climate-related events impact a wide range of health outcomes. Some of
the most significant climate-related events-such as heat waves, floods,
droughts, and extreme storms-affect everyone. These climate events
compromise our access to clean air, clean water, and a reliable food
supply. In addition, climate events can impact the presence of
allergens and vectors, like ticks and mosquitoes, and the subsequent
health outcomes that can result from these changes in exposures. We
know that a changing climate can intensify existing public health
threats, and that new health threats will emerge: unequally distributed
risks (age, economic resources, location), increased respiratory and
cardiovascular disease, injuries and premature deaths related to
extreme weather events, changing prevalence and geography of foodborne
and waterborne illnesses and other infectious diseases, and threats to
mental health as people feel less safe.
CDC works with states, cities, and tribes to apply the best climate
science available, predicting health impacts, and preparing public
health programs to protect their communities. To do this, CDC developed
the Building Resilience Against Climate Effects (BRACE) framework to
help communities prepare for the health effects of climate change by
anticipating climate impacts, assessing vulnerabilities, projecting
disease burden, assessing public health interventions, developing
adaptation plans, and evaluating the impact and quality of activities.
With the requested increase in FY 2022, we can further expand the
Climate and Health Program by providing a larger number of health
departments with technical assistance and funding and finding
innovative ways to protect health via climate adaptations. As with
every other public health threat, we will inform our effort by building
and examining systems that collect data on conditions related to
climate, including asthma and vector-borne diseases, and coordinate
programs and communication that improve health outcomes.
The opioid epidemic has shattered families, claimed lives, and
ravaged communities across the Nation-and the COVID-19 pandemic has
only deepened this crisis. Addressing the current overdose epidemic
remains a priority for CDC. The Administration's strategy brings
together surveillance, prevention, treatment, recovery, law
enforcement, interdiction, and source-country efforts to address the
continuum of challenges facing this country due to drug use. CDC's role
is to prevent drug-related harms and overdose deaths.
The additional funding requested in FY 2022 to address the opioid
epidemic will enable CDC to provide more funding to all States,
Territories, and select cities/counties. CDC will prioritize support to
collect and report real-time, robust overdose mortality data and to
move from data to action, building upon the work of the Overdose Data
to Action (OD2A) program. To do so, CDC will partner with funded
jurisdictions to implement surveillance strategies that include
contextual information alongside data, as well as increase surveillance
capabilities for polysubstance use and emerging substance threats such
as stimulants. The additional resources requested will enable CDC to
support investments in prevention efforts for people put at highest
risk, for example, supporting risk reduction and access to medications
for opioid use disorder for people transitioning from alternate
residence (jail/prison, treatment facility, homeless shelter). CDC will
also address infectious disease consequences, such as viral hepatitis,
of the opioid epidemic.
I look forward to working together to address both the immediate
challenges ahead in our fight against COVID-19, as well as the
weaknesses in the public health infrastructure that left our country
vulnerable to this pandemic. We at CDC are grateful for your support.
We will continue to work tirelessly to ensure the health of this nation
and the world. Together, we can build a sustainable and resilient
public health system that can respond effectively to emerging threats
and also to ongoing public health needs of every American.
[This statement was submitted by Rochelle P. Walensky, M.D.,
M.P.H., Director, and Anne Schuchat, M.D.,Principal Deputy Director,
Centers for Disease Control and Prevention.]
______
Prepared Statement of the Christopher & Dana Reeve Foundation
Thank you for this opportunity to submit testimony in support of an
appropriation of $9,700,000 for the Paralysis Resource Center (PRC)
within the Administration for Community Living (ACL) at the Department
of Health and Human Services (HHS).
I am proud to speak on behalf of the 1 in 50 individuals living
with paralysis in the United States, who rely on programs like the
Paralysis Resource Center to live independent and empowered lives. The
Reeve Foundation has operated the Paralysis Resource Center for 19
years, competing in a rigorous, competitive bidding process every three
years for renewal of this grant. For fiscal year 2022, we request
funding of $9.7 million for the Paralysis Resource Center. Of this
total, we request that the Committee direct no less than $8.7 million
to the National Paralysis Resource Center. These requests are in line
with the final appropriation for FY21. The Reeve Foundation was also
pleased to see that the President's Budget for FY22 requests a 5%
increase for the Paralysis Resource Center.
When Christopher Reeve was paralyzed from the neck down due to a
spinal cord injury in 1995, his family found themselves in total
darkness as to what to do next. There was no phone number to call for
guidance or help. There were no experts reaching out to connect them to
the right rehabilitation facilities, or to discuss how they could
support his return home and ongoing well-being. There was certainly no
promise that an individual living with that level of spinal cord injury
could lead a full and active life as a father and husband. Yet, instead
of accepting that life with paralysis would be full of limitations, he
dreamed of a brighter future.
That was the genesis of the Christopher & Dana Reeve Foundation:
Christopher's dream to elevate the needs and rights of the 5.4 million
Americans living with paralysis. But he was far from alone. The real
drive behind the Paralysis Resource Center came from his wife, Dana. As
a caregiver herself, she knew that paralyzed individuals and caregivers
around the country needed a centralized place to call for resources and
expertise.
Since the PRC opened its doors in 2002, it has served as a free,
comprehensive, national source of informational support for people
living with paralysis and their caregivers. Our work is deeply aligned
with ACL's mission to empower people living with disabilities and older
adults to live independently and participate in their communities
throughout their lives. The PRC is the only program of its kind that
directly serves individuals living with spinal cord injury, MS, ALS,
stroke, spina bifida, cerebral palsy and other forms of paralysis. The
services and programs described below would not be possible without the
ongoing support of this Subcommittee.
A. The PRC's Core Programs
(1) Information Specialists. One of the PRC's most essential
functions is the team of certified, trained Information Specialists
(IS) who provide personalized support to individuals, families, and
caregivers on how to navigate the challenges of life with paralysis.
This team of experts, many living with paralysis themselves, are often
the first port of call for individuals who are newly injured or
diagnosed. Just twenty-four hours after my daughter, Ellie, sustained a
spinal cord injury, I contacted the Paralysis Resource Center. The same
day I was told my daughter would probably never walk again; I was
offered a lifeline. I believe that call turned the nose of the Titanic
away from the iceberg before it hit us. It altered the course of
desperation and isolation of what we were dealing with and gave us real
hope. I was assured that Ellie would drive again, work again, and enjoy
her life--and that the Foundation and the PRC team would hold my hand
the entire way. It is also important to note how critically their
services have been educating and supporting the paralysis community
during the pandemic.
To date, the PRC Information Specialists have provided direct
counseling to over 106,000 people. We have distributed 220,000 copies
of our Paralysis Resource Guide, which is a staple in hospitals and
rehabilitation facilities across the country.
(2) Peer & Family Support Program. A second pillar of the PRC is
our Peer & Family Support Program. This program is born of the idea
that the best source of knowledge is experience: and that peer-to-peer
connections empower not only the newly paralyzed individual, but also
the mentor. Through the PRC, more than 450 peer mentors have been
trained and certified in 43 states and Washington, DC. These
individuals have mentored over 17,000 peers.
(3) Quality of Life Grants Program. Our third pillar, the Quality
of Life Grants Program, operates at the community level to fund
nonprofit initiatives in all 50 states, the District of Columbia and
the U.S. territories. Since 1999, the Quality-of-Life Grants Program
has directed over $33 million dollars to assist over 3,300 projects.
This program has increased employment trainings and accessible
transportation; established adaptive sports programs and camps for
children; improved access to buildings, playgrounds, and universities;
helped individuals learn how to manage their financial well-being and
provided support services for veterans. In 2020, the PRC created a new
Quality of Life (QOL) grants program specifically aimed at addressing
social isolation during the COVID-19 pandemic, with the goal of
enhancing connectedness of people living with paralysis and their
caregivers to their communities and preventing adverse health outcomes.
(4) Military & Veterans Program; Multicultural Outreach Program.
The PRC has a comprehensive Military and Veterans Program, which
provides dedicated resources to help individuals navigate military and
civilian benefits and programs as they reintegrate into their
communities. The PRC also facilitates a Multicultural Outreach Program
that is designed to engage and support underserved populations like
racial and ethnic minorities, older adults, low-income earners, and
LGBTQ individuals.
(5) ChristopherReeve.org. One of the most challenging aspects about
living with paralysis is combating feelings of isolation and exclusion,
especially for those who are unable to leave their homes due to
physical and societal barriers. The Reeve Foundation's website,
ChristopherReeve.org, provides a vibrant online community and resource
hub as part of the PRC, which attracts close to three million visitors
per year, and Reeve Connect, our online forum, has allowed over 8,000
individuals to connect with experts, chat with one another and share
the experiences that matter to them in a secure, private space.
B. The Importance of Federal Funding.
I would like to close my remarks by emphasizing why federal funding
for this program is so important. Simply put neither the Reeve
Foundation, nor any organization competing to run the PRC, could
provide this type of centralized resource alone. Because many
individuals, including my daughter, are required to attend
rehabilitation clinics and/or draw on other resources from out of
state, nationwide expertise is required. To get the benefit of
investing in a centralized hub of information, we need to promote and
deliver these services at scale. Federal funds are essential for this
valuable, life-changing resource to work.
Christopher Reeve once said, ``Hope is like a lighthouse,'' helping
individuals who are lost in the darkness find their way. But like a
lighthouse, hope must be built on solid foundations. The resources,
support and community created by the PRC are the foundation for hope
for millions of individuals affected by paralysis around the country. I
thank you for your ongoing support and urge you to protect the
Paralysis Resource Center so that individuals nationwide can achieve
greater quality of life, health, and independence. Thank you.
______
Prepared Statement of the Coalition for Clinical and
Translational Science
fiscal year 2022 appropriations recommendations
_______________________________________________________________________
--CCTS joins the broader medical research community in asking
Congress to provide the National Institutes of Health (NIH)
with at least a $3.2 billion funding increase for FY22, to
bring total agency funding up to a minimum of $46.1billion
annually.
--Please provide the Clinical and Translational Science Awards
(CTSA) program at the National Center for Advancing
Translational Sciences (NCATS) with at least a $32 million
increase in dedicated line-item funding for FY22 to bring
annual support for the program up to a minimum of $620
million.
--Please provide the Cures Acceleration Network (CAN) at NCATS with
$100 million in dedicated funding for FY22.
--Please provide the Institutional Development Awards (IDeA)
program and the Research Centers in Minority Institutions
(RCMI) program at NIH with meaningful proportional funding
increases for FY22.
--CCTS joins the broader public health community in requesting $500
million for the Agency for Healthcare Research and Quality
(AHRQ).
--CCTS joins the broader public health community in requesting $10
billion for the Centers for Disease Control and Prevention
(CDC).
_______________________________________________________________________
Chairwoman Murray, Ranking Member Blunt, and distinguished members
of the Subcommittee, thank you for considering the views of the
clinical and translational research community as work on FY 2022
appropriations. The community deeply appreciates the ongoing investment
in medical research, including FY21 NIH funding and overall support for
the COVID-19 response. Moreover, CCTS commends you for continuing to
protect line-item funding for the CTSA program, which provides critical
research infrastructure support to meritorious institutions across the
country and serves as a major catalyst for advancing the full spectrum
of medical research at NIH. The value, importance, and impact of the
CTSA program as well as full-spectrum research at NIH was best
highlighted by our ability to quickly develop treatments, vaccines,
diagnostic tools, and health information to quickly respond to the
ongoing COVID-19 pandemic. As you consider FY 2022 funding, CCTS and
the broader community would like to highlight recent progress, emerging
opportunities, and the importance of sustained investment.
about the coalition for clinical and translational science
The Association for Clinical and Translational Science, Clinical
Research Forum, the CTSA PIs, and the related stakeholder community
work together through the Coalition for Clinical and Translational
Science (CCTS) to speak out with a unified voice on behalf of the
clinical and translational research community. CCTS is a nationwide,
grassroots network of dedicated individuals who seek to educate
Congress and the administration about the value and importance of
clinical and translational research, and research training and career
development activities. Our goals are to ensure that the full spectrum
of medical research is adequately funded, the next generation of
researchers is well-prepared, and the regulatory and public policy
environment facilitates ongoing expansion and advancement of the field
of clinical and translational science.
about the ctsa program and the full spectrum of medical research
The CTSA Program was established to disseminate medical and
population health interventions to patients and populations more
quickly, and to enable research teams, including scientists, patient
advocacy organizations and community members, to tackle system-wide
scientific and operational problems in clinical and translational
research that no one team can overcome in isolation. The CTSA program
honors the promise of the Cures Act by improving research
infrastructure and accelerating the rate at which breakthroughs in
basic science are translated to innovations with a tangible benefit to
patients.
The goals of the CTSA program include; (1) train and cultivate the
translational science workforce, (2) engage patients and communities in
every phase of the translational process, (3) promote the integration
of special and underserved populations in translational research across
the human lifespan, (4) innovate processes to increase the quality and
efficiency of translational research, particularly of multisite trials,
(5) advance the use of cutting-edge informatics.
The CTSA Program supports a national network of ``hubs'' at
academic research centers across the country that work collaboratively
to improve the translational research process to get more treatments to
more patients more quickly. The hubs collaborate locally and regionally
to catalyze innovation in research training, tools, and processes.
Approximately 60 medical research institutions across the nation
currently receive CTSA program funding, and these hubs work together to
speed the translation of research discovery into improved patient care
and public health. Resources appropriated to these hubs allow the
network to expand to include additional sites, advance science, and
directly invest in the health workforce of the communities where they
are located.
The full spectrum of translational science takes the fruits of
basic and pre-clinical research and translates them into effective
clinical care and public health measures, with a focus on having impact
on health. In order to maximize efficiency and patient-centeredness,
this research must be done collaboratively and in a systematic way.
This team-science approach focuses on outcomes and patient/health
system benefits, rather than the advancement of science for the sake of
science.
Most crucially, the appropriations committees have included
detailed committee recommendations in the past that have facilitated
meaningful advancements for the full spectrum of medical research, the
CTSA program, and career development for early stage investigators and
we hope similar recommendations advancing full spectrum research and
team science as well as maintaining the integrity of the CTSA line-item
will be provided for FY 2022.
recent ctsa activity
Yale Center for Clinical Investigation (YCCI)
YCCI initiated double-blind randomized outpatient covid treatment
trials involving the experimental drug apilimod dimesylate (LAM-002A),
a first in class, highly selective PIKfyve kinase inhibitor from
Connecticut Biotech firm AI therapeutics, which prevents SARS-CoV-2
viral entry into cells. Similarly, a randomized, double blind
outpatient repurposing trial of camostat mesylate, which inhibits SARS-
CoV-2 infection by blocking the virus-activating host cell protease
TMPRSS2, was simultaneously initiated. YCCI also supported
participation in multi-institutional randomized placebo controlled
trials including Pfizer-sponsored vaccine trials and a randomized,
placebo controlled cooperative inpatient trial of convalescent plasma
by a consortium of CTSA institutions. Innovative pandemic monitoring
approaches were developed including the measuring of SARS-CoV-2 RNA
concentrations in primary municipal sewage sludgeas a leading indicator
of COVID-19 outbreak dynamics.
The YCCI's Cultural Ambassador program, initiated eleven years ago,
has been a critical component in the response to the pandemic. This bi-
directional partnership influences Yale research priorities and drives
research that meets the needs of the surrounding community. The
Cultural Ambassadors, appointed by the community, collaborate with Yale
researchers on trial design, recruitment, and reducing access barriers
for the community and engage in advocacy and education efforts in the
community, driving awareness of the importance of clinical research.
The program builds trust-based relationships, increases health system
engagement and contributes to improved overall health. This has been
the lynchpin for community-based clinical trials that has resulted in
participation in clinical trials by underrepresented minorities of 31%
in the last academic year.
University of Washington
Limiting Opioid Abuse.--Over the last several years, our CTSA has
organized dozens of rural clinics into a network. This network
initiated an observational study of best practices in the management of
patients who are on long-term opioid therapy for chronic pain, which
evolved into a prescribing program. Rigorous testing of the developed
intervention at 20 rural practice sites demonstrated a 19% reduction in
high dose opioid prescribing.
COVID Clinical Trials in Rural Communities.--The UW CTSA, through
the development of the rural clinic network, was able to push clinical
trials from the UW to rural Washington rapidly. Providence Health in
Spokane, WA, one of our Network partners, was 1 of the first 10 US
sites to open the ACTIV-1 trial and enrolled their first participant 5
days after receiving the protocol. Inclusion of rural serving clinical
sites was critical to our regional communities as COVID-19 infections
were increasing dramatically in migrant farm worker populations.
Vanderbilt
The Vanderbilt Institute for Clinical and Translational research
was well positioned to respond to the pandemic in large part because of
the CTSA-supported infrastructure. First, the local ecosystem was
mobilized to organize and coordinate the local response. From this, we
identified the need to harmonize various trial activities across the
country, and NCATS supported initiatives for harmonizing COVID-19 trial
oversight and data pooling. At the same time, we were positioned to
conduct clinical trials with efficient contracting and regulatory
approvals, launching PassItOn--a trial of convalescent plasma--with
seed funding from Dolly Parton. NCATS supported the rest of the trial,
which has almost reached its enrollment target of 1000 patients. We
were also identified as the science unit for NHLBI's network of
networks, providing guidance to the agent selection, design, and
analysis of trials of the host-tissue response to SARS-CoV-2 infection,
building on the success of our drug repurposing program and
biostatistics programs. Continuing to springboard of these foundations,
we are now leading ACTIV4D-RAAS and serving as the DCC for ACTIV6, this
latter with funding through NCATS. Lastly, our CTSA-supported learning
health system has completed the only known large, randomized controlled
of prone positioning in moderately sick inpatients, with results in the
process of being disseminated.
University of Texas Health Science Center at San Antonio
Resources, facilities, and personnel from the Institute for
Integration of Medicine & Science, home to the UTHSCSA CTSA grant,
enabled a rapid, collaborative, and comprehensive response to the
COVID-19 crisis. Within weeks of the pandemic onset, UTHSCA established
a unique virtual clinic for newly diagnosed patients. Research teams
are characterizing health disparities and COVID-19 symptoms in this
majority (84%) Hispanic population. As part of the NIH Community
Engagement Alliance Against COVID-19 Disparities, CTSA specialists
partner with regional health professionals and local organizations in
underserved regions across South Texas to provide expert community
engagement, community based-participatory research, and dissemination
of best practices for COVID-19 care. As a result of the extensive
preparation of CTSA hub and network research infrastructure, UTHSCA was
among the top enrolling sites for major national studies including the
NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines
(ACTIV) trials. CTSA support was also instrumental in launching a
pioneering study of immunological resilience in 522 Veterans with
COVID-19, which has yielded new biomarkers and new insights into the
relative vulnerability of males to serious illness.
[This statement was submitted by Harry P. Selker, MD, MSPH,
Chairman,
Clinical Research Forum.]
______
Prepared Statement of the Coalition for Health Funding
The Coalition for Health Funding--an alliance of 81 national health
organizations representing more than 100 million patients and
consumers, health providers, professionals and researchers--appreciates
the opportunity to submit testimony for the record about the importance
of health funding. Together, our members speak with one voice in
support of federally funded health programs with a shared goal of
improved health and well-being for all. While each member organization
has its own funding priorities within the Department of Health and
Human Services (HHS), our coalition is united in support of increased
and sustained funding for all federal agencies and programs across the
public health continuum--from bench to bedside--to ensure that all
Americans lead long, healthy, productive lives.
Today, we have an unprecedented opportunity to shape the future of
this country's public health infrastructure. The COVID-19 pandemic
critically strained health, social, and economic systems around the
world, and highlighted the importance of sustained and predictable
health funding. Supplemental funding to address the urgent needs of the
pandemic was, and continues to be, essential, but it alone is not the
solution to respond to future pandemics. For too long, Congress
neglected critical pieces of our public health infrastructure and
health research pipeline, which hindered our ability to respond quickly
and effectively when disaster struck. Now is the time to take
corrective action and make sustained investment in public health. We
learned many lessons during the pandemic, including that biomedical
research and a robust public health workforce are indispensable and
require sustained investment. A significant fiscal year (FY) 2022
allocation for public health funding will allow our health systems to
emerge stronger and better equipped to improve health outcomes.
The Coalition urges Congress to seize the opportunity FY 2022
presents as the first appropriations cycle in a decade not governed by
the spending caps of the Budget Control Act of 2011 (BCA). Without the
BCA imposed budget caps, Congress should provide funding increases
across the HHS accounts commensurate with the need for non-defense
discretionary programs that support public health, medical and
scientific research, infrastructure, education, public safety, and
more. Congress should follow the increase set forth in President
Biden's FY 2022 Discretionary Budget request and increase the HHS
budget by at least 23.5 percent or $25 billion above FY 2021 levels.
Increased funding will not only support future economic growth, but
will strengthen the health, safety, and security of all Americans.
HHS agencies play a key role in addressing our nation's public
health needs and work in partnership with state and local governments
to protect and promote health in our communities. While each agency
within HHS has a unique mission to respond to our nation's health
demands, they are all interconnected. For example, the COVID-19
pandemic has shown that investment in medical research at the National
Institutes of Health (NIH) is important, but on its own will not
improve health. You need the Food and Drug Administration to approve
new treatments. You need the Centers for Disease Control and
Prevention, Health Resources and Services Administration, Substance
Abuse and Mental Health Services Administration, and Indian Health
Service to ensure we have qualified health professionals who can
translate research into health care and public health delivery, support
Americans while they're awaiting new cures, and prevent them from
getting sick in the first place. You also need the Agency for
Healthcare Research and Quality to provide clinical evidence on what
treatments work best, for whom, and in what circumstances. And you need
the Administration for Community Living to support those who are aging
and those who have disabilities--as well as their caregivers--so that
they can live their best life, every day. Without robust funding for
all agencies and programs of the interdependent public health
continuum, we're falling short on the promise to protect and improve
the health and well-being of all Americans. Shortchanging public health
and health research programs--or cutting health programs--leaves
Americans vulnerable to health threats and will not prevent public
health crises from arising in the first place as we witnessed over the
last year.
As COVID-19 cases begin to decline and life starts to look more
like it did before the pandemic, it is important to recognize that the
pandemic's effects go far beyond the virus itself and will have long-
lasting impacts on Americans. Research is just one of the many areas
impacted by the pandemic that requires additional investment to get
back on track. Every agency within HHS conducts research that is
important to strengthening our public health system. Congress has a
responsibility to ensure that all agencies within HHS receive equitable
funding for efforts to regain some of the ground that has been lost due
to necessary pauses in and increased costs of research as well as
ensure the pandemic does not wipe out a whole generation of
investigators who were forced to choose other career paths because of
the disruption.
Another well-established impact of the pandemic has been the toll
it has taken on mental health and substance abuse. Four in ten adults
report symptoms of anxiety or a depressive disorder, up from one in ten
adults in June 2019. Substance abuse and misuse, including alcohol, has
increased by 12 percent.\1\ Gains made in the fight against the opioid
epidemic-another dire public health crisis-were diminished as an
estimated 87,000 Americans lost their lives due to overdose from
September 2019 to September 2020, a 29 percent increase over the
previous year.\2\ Adequate funding for preventive, supportive, and
rehabilitative services will be critical to address and reduce these
concerning trends.
---------------------------------------------------------------------------
\1\ Nirmita Panchal, R. K., & 2021, F. (2021, April 14). The
Implications of COVID-19 for Mental Health and Substance Use. KFF.
https://www.kff.org/coronavirus-covid-19/issue-brief/the-implications-
of-covid-19-for-mental-health-and-substance-use/.
\2\ Centers for Disease Control and Prevention. (2021, May 12).
Products--Vital Statistics Rapid Release--Provisional Drug Overdose
Data. Centers for Disease Control and Prevention. https://www.cdc.gov/
nchs/nvss/vsrr/drug-overdose-data.htm.
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The detection and management of chronic diseases is another area of
public health that was set back as a result of the pandemic. An
estimated six in ten American adults have a chronic disease, with four
in ten having two or more.\3\ Restrictions on elective procedures and
non-urgent health care visits, coupled with concerns about the virus
and obstacles to connecting virtually with providers during the
pandemic caused many Americans to postpone routine care and skip
necessary screenings, which in some cases has negatively impacted
patients' ability to manage their disease.\4\ Additionally, the
millions of Americans now living with post-acute sequelae of COVID-19-
often referred to as ``long-haulers'' because they experience lingering
symptoms that last from weeks to months-could further increase the
number of people in the U.S. living with a chronic disease, like
diabetes or heart disease, and adds new complexities to our chronic
disease management efforts. As a result, there is a significant need
for increased funding for public health programs that reduce barriers
to care and help patients detect and manage their conditions.
---------------------------------------------------------------------------
\3\ Centers for Disease Control and Prevention. (2021, January 12).
Chronic Diseases in America. Centers for Disease Control and
Prevention. https://www.cdc.gov/chronicdisease/resources/infographic/
chronic-diseases.htm.
\4\ Kendzerska, T., Zhu, D. T., Gershon, A. S., Edwards, J. D.,
Peixoto, C., Robillard, R., & Kendall, C. E. (2021, February 15). The
Effects of the Health System Response to the COVID-19 Pandemic on
Chronic Disease Management: A Narrative Review. Risk management and
healthcare policy. https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC7894869/#: :text=Obese%
20patients%20with%20chronic%20diseases,during%20in%2Dperson%20medical%20
visits.
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Research, mental health, substance use disorders, and chronic
disease are just some of the areas of public health that have been
impacted by the pandemic and require increased investments. Despite the
funding included in the emergency appropriations packages, we have seen
setbacks in most, if not all, areas of public health. The only way to
remedy this situation is through robust and sustained funding. As the
country continues to work to build back, Congress has a responsibility
to make robust, sustained, investments in our public health system.
Health security is national security; Congress would not hesitate,
rightfully so, to make increased investments in defense or national
security after a crisis. Now is our chance to act boldly and make
investments in public health that will benefit all Americans. The goal
for our nation's public health system should not be to return to
normal, but rather to build a paradigm that makes the U.S. a healthier
country by addressing health disparities and ensures that when the next
public health crisis comes, we are prepared.
The Coalition for Health Funding strongly supports at least a 23.5
percent increase for the Department of Health and Human Services above
FY 2021 levels. We look forward to working with Congress to support the
health of all Americans and we hope that you will view us and our
member organizations as a resource.
[This statement was submitted by Erin Morton, MA, Executive
Director, Coalition for Health Funding.]
______
Prepared Statement of the Coalition for Service Learning
On behalf of the Coalition for Service Learning and the 160+
organizations we represent, we respectfully request that you include a
$250 million annual appropriation for the Learn and Serve America
program and related National Service Trust payments authorized by
Subtitle B of the Edward M. Kennedy Serve America Act in the FY22
Labor, Health and Human Services, Education and Related Agencies
Appropriations bill for the Corporation for National and Community
Service (CNCS) dba AmeriCorps.
Additionally, we request that accompanying report language include
the following:
``Within the total, the Committee provides funds for Summer of
Service programs, Semester of Service programs, and Innovative and
Community-Based Service-Learning programs in public schools and
institutions of higher education. Additionally, fifty-percent of the
funds are to be directed to economically disadvantaged communities and
at least five-percent to be set aside for payments to Indian tribes and
territories. Grants to disadvantaged communities are exempt from match
requirements. There shall be a two-percent set-aside of the total
appropriation for training and technical assistance contracts and
program evaluation.''
Lastly, since the AmeriCorps agency will need to increase their
capacity in order to administer these new programs, we request that
such sums as may be necessary shall be appropriated for agency salaries
and expenses under Subtitle K of the Serve America Act and such sums as
may be necessary for education awards for Summer of Service
participants in the National Service Trust.
The COVID-19 pandemic has amplified existing inequities in
education, isolated individuals, and put students' educational outcomes
at risk. Students are struggling academically but also socially and
emotionally, especially those in underserved areas. Engaging students
through service-learning is a proven way to instill a sense of
community, belonging, and responsibility and is a proven strategy to
help address the academic and emotional learning loss that has
occurred.
The congressionally-appointed bipartisan National Commission on
Military, National, and Public Service completed a report in March of
2020 in which it set a goal of all K-12 students receiving service-
learning experiences by 2031. It highlighted the opportunity to give
young people the problem-solving and academic achievement skills they
will need to be successful in school, work, and life. In the
Commission's vision, every American would be exposed to service
opportunities throughout their lifetime, beginning with young people
experiencing robust civic education and service-learning during
elementary, middle, and high school.
In order to achieve this vision, the Commission recommended that
Congress provide a $250 million annual appropriation to CNCS to award
competitive grants to SEAs, LEAs, IHEs, State Service Commissions, and
nonprofits to develop and implement service-learning programs for K-12
and postsecondary students across the country, including:
--$100 million for Summer of Service programs for students who will
be enrolled in grades 6-12 at the end of the summer;
--$100 million for Semester of Service programs for students in
grades 9-12; and
--$50 million for service-learning programs in public schools and
institutions of higher education.
Dedicated resources for educators and districts are essential for
the success of service-learning programs. Funding would enable school
districts to provide teachers with the training and support needed to
develop their service-learning skills and to build service-learning
activities into their curricula. Funding for Learn and Serve America
would help lower financial barriers and incentivize schools and
educators to actively promote and incorporate service-learning into
classrooms across the nation.
Service-learning is a critical program strategy at the intersection
of education, national service, and civic health, with positive impacts
on increasing academic engagement and 21st Century skill development,
meeting community needs while building a recruitment pipeline for
AmeriCorps programs, and improving civic education and participation.
We are hopeful that Congress recognizes the importance of
reestablishing a program that will help address academic and emotional
learning loss, re-engage students through service-learning activities,
and instill a sense of community. We urge Congress to provide $250
million for Learn and Serve America and are grateful for your
consideration of this request.
Best regards,
Amy Cohen, Executive Director, The George Washington University
Honey W. Nashman Center for Civic Engagement and Public Service, and
Former Director of Learn and Serve America
Susan Stroud, Senior Fellow, The George Washington University Honey
W. Nashman Center for Civic Engagement and Public Service, and Founding
Director of Learn and Serve America
Emily Samose, Founder, ECS Consulting, and Former Staff, Learn and
Serve America
Brad Lewis, Former Staff, Learn and Serve America
Amy Meuers, CEO, National Youth Leadership Council
Aaron Dworkin, CEO, National Summer Learning Association
Ally Talcott, Step Up Advocacy for the National Summer Learning
Association
Kate Cumbo, Executive Director, PeaceJam Foundation
Kaira Esgate, CEO, States for Service and America's Service
Commissions
Susan Abravanel, President, Susan Abravanel Consulting
Michael Minks, Vice President of Operations, Youth Service America
Steven A. Culbertson, President & CEO, Youth Service America
Coalition Members--National Organizations
Erik Peterson, Senior Vice President of Policy, Afterschool Alliance
Gary Kosman, CEO, America Learns
Dr. Ariel King, President, Ariel Foundation International
Abby Robinson, Acting CEO, Atlas Corps
Sage Learn, National Director of Government Relations, Boys & Girls
Clubs of America
Shawna Rosenzweig, Chief Strategy Officer, Camp Fire National
Headquarters
Andrew Seligsohn, President, Campus Compact
Kei Kawashima-Ginsberg, Director, The Center for Information &
Research on Civic Learning & Engagement, Jonathan M. Tisch College at
Tufts University
John Bridgeland, Founder &CEO, Civic
Robert Hackett, President, Corella & Bertram F. Bonner Foundation
Sanjli Gidwaney, Director, Design for Change USA
Marly Leighton, Chief of Staff, DoSomething.org
Vince Meldrum, President/CEO, Earth Force
Tamara Roske, Executive Director, Earth Guardians
Donna Ritter, Executive Director, Educators Consortium for Service
Learning
Adam Fletcher, Director, Freechild Institute
Amanda Antico, Founder, EvolvED Global
Stefonie Sebastian, Senior Service Engagement Specialist, National
FFA Organization
Donna Butts, Executive Director, Generations United
Linda Staheli, Founding Director, Global Collaboration Lab Network
Rick Lathrop, Founder/Executive Director, Global Service Corps
Sam Fankuchen, Founder & CEO, Golden
Patricia Hall, Founder, H2O for Life
Nichole Cirillo, Executive Director, IAVE
Serita Cox, CEO, iFoster
Doug Bolton, CEO, Cincinnati Cares, Inspiring Service
Bradley Hill, Director of Growth and Strategic Partnership, Junior
State of America
Betsy Peterson, Executive Director, Learning to Give
Robert Jackson, Sr. Director of Development, Martin Luther King Jr.
Center for Nonviolent Social Change
Abbie Evans, Senior Director, Government Relations, MENTOR
Sarah Fanslau, VP, Youth Programs, Multiplying Good
Gina Warner, President & CEO, National Afterschool Association
Kuna Tavalin, Consultant, National Center for Families Learning
Lawrence Paska, Executive Director, National Council for the Social
Studies
McClellan Hall, Founder, CEO, National Indian Youth Leadership
Project
Stephanie Grove, President, National Senior Corps Association (NSCA)
Fish Stark, Global Director of Programs, Peace First
Moran Banai, Managing Director, Policy and Government Relations,
Service Year Alliance
Lee Arbetman, Executive Director, Street Law
Derek Summerville, Director of Youth Engagement, YMCA of the USA
Adam Fletcher, Vice-President, Youth and Educators Succeeding
David Battey, President and Founder, Youth Volunteer Corps
Coalition Members--State & Local Organizations (listed alphabetically
by State)
Kids 1st Awareness Community Center (AL)
Blue Crew (CA)
California Campus Compact (CA)
CBK Associates (CA)
Cooline Team of East Palo Alto (CA)
Norte Vista High School (CA)
Playable Agency (CA)
S.C.R.A.P. Gallery (CA)
1 Sacred Place (CO)
Billig Consulting (CO)
Goldey (DE)
American University Center for Community Engagement & Service (DC)
Center for Social Justice Research Teaching & Service (DC)
Griffin Legacy & Associates (DC)
LearnServe International (DC)
Raising A Village Foundation (DC)
Beyond Before Community Development Corporation (FL)
Florida Atlantic University (FL)
FSU Center for Leadership and Social Change (FL)
Jacksonville University (FL)
Chautauqua Learn and Serve Charter School (FL)
Intentional Icon Inc (FL)
Miami Dade College Institute for Civic Engagement and Democracy (FL)
AFRD Georgia (GA)
Favor House (GA)
John & JeJuan Stewart Jr. Foundation (GA)
KIPP South Fulton Academy Beta Club (GA)
The Bridge Foundation (GA)
Making Dreams Come True Valley of Rainbows (HI)
Hawaii Pacific Islands Campus Compact (HI)
University of Hawaii Office of Civic and Community Engagement (HI)
Serve Illinois Commission (IL)
ProAct Indy (IN)
Serve Indiana Commission (IN)
Volunteer Center of Story County (IA)
Bluebird Experience (KY)
Kentucky Campus Compact (KY)
LSU AgCenter 4 (LA)
3Levels.org (ME)
Bates College (ME)
Harkins Consulting (ME)
Maine Campus Compact (ME)
Saint Joseph's College of Maine (ME)
Loyola University Maryland Center for Community (MD)
The Giving Square (MD)
University of Maryland College Park (MD)
Campus Compact Mid (MD)
No Struggle No Success (MD)
Notre Dame of Maryland University (MD)
The WordSmith (MD)
UMBC The Shriver Center (MD)
Wicomico County Public Schools MD (MD)
Jonathan M. Tisch College of Civic Life at Tufts University (MA)
Action 2 Achieve (MA)
Brandeis Center for Youth and Communities University (MA)
LEAP Arlington (MA)
Michigan Community Service Commission (MI)
West Michigan Consulting Services (MI)
Peacebunny Islands Inc/Peacebunny Foundation (MN)
Youthprise (MN)
Black Girls Rock of MS (MS)
CryOut Teen Organization (MS)
Missouri Community Service Commission (MO)
Center of Effort LLC (MO)
Montana Education Partnership (MT)
Boulder Elementary School (MT)
New Generation for a New World (NJ)
New Jersey Campus Compact (NJ)
Operation Grow Inc. (NJ)
Rider University (NJ)
Campus Compact of NY & PA (NY)
Grandma's Love Inc. (NY)
Hobart and William Smith Colleges/Geneva 2030 (NY)
Wagner College (NY)
GenerationNation (NC)
Ladies of Purpose Social Group Inc. (NC)
North Carolina Campus Compact (NC)
North Carolina Service Learning Coalition (NC)
Northern Marianas College (MP)
John Carroll University Center for Service & Social Action (OH)
Ohio Campus Compact (OH)
The Hero Within You Network (OH)
Oklahoma AmeriCorps (OK)
Camp Fire Central Oregon (OR)
Campus Compact of Oregon (OR)
Ecumenical Ministries of Oregon: Northeast Emergency Food Program
(OR)
Drexel University School Improvement Project (OR)
Drexel University Lindy Center for Civic Engagement (OR)
My New Journeys (PA)
University of Pennsylvania Netter Center for Community Partnerships
(PA)
Blackstone Academy (RI)
Carter County Drug Prevention (TN)
Carter County Drug Prevention/Keep Carter County Beautiful (TN)
Volunteer Tennessee (TN)
CAVALRY (TX)
City of Houston Volunteer Initiative Programs Office (TX)
El Paso Community College (TX)
Student Advocacy Coalition (TX)
The Leaders Readers Network (TX)
Sunrise High School (UT)
FYR is LIT (VI)
EDGE Consulting Partners (VA)
Independent Consultant K (VA)
OccupyFaith (WA)
Washington Campus Compact (WA)
Volunteer Center of Racine County (WI)
______
Prepared Statement of College on Problems of Drug Dependence
Thank you for the opportunity to submit testimony in support of the
National Institute on Drug Abuse (NIDA). The College on Problems of
Drug Dependence (CPDD), a membership organization with over 1000
members, has been in existence since 1929. It is the longest standing
group of scholars in the U.S. addressing problems related to substance
use disorders. CPDD serves as an interface among government, industry
and academic communities maintaining liaisons with regulatory and
research agencies as well as education, treatment, and prevention
facilities in the substance use disorder field.
In the Fiscal Year 2022 Labor, Health and Human Services
Appropriations bill we request that the subcommittee include the
President's requested level of $51 billion for the National Institutes
of Health (NIH), including no less than $46.1 billion for NIH's base
program level budget. In addition, we greatly appreciate the President
Budget's recognition of the need to significantly increase our nation's
investment in the National Institute on Drug Abuse (NIDA) and its
response to the opioid epidemic. The President's Fiscal 2022 Budget
recommends a $372.2 million increase in NIDA's budget, a 25 percent
increase. We strongly encourage the Subcommittee to include the
President's recommended funding level of $1.852 billion for NIDA in the
Senate version of the Fiscal Year 2022 Labor, Health and Human Services
Appropriations bill.
We also respectfully request the inclusion of the following NIDA
specific report language.
Opioid Initiative. The Committee continues to be concerned about
the opioid overdose epidemic and appreciates the important role that
research plays in the various federal initiatives aimed at this crisis.
The Committee is also aware of the most recent data from the Centers
for Disease Control and Prevention that shows opioid overdose
fatalities increasing from 2018 to 2019, with the primary driver being
the increased overdose deaths involving synthetic opioids, primarily
illicitly manufactured fentanyls. To combat this crisis the Committee
has provided within NIDA's budget no less than $270,295,000 for the
Institute's share of the HEAL Initiative and in response to rising
rates of stimulant use and overdose, the Committee has included
language expanding the allowable use of these funds to include research
related to stimulant use and addiction.
Methamphetamine and Other Stimulants. The Committee is concerned
that, according to data released by the Centers for Disease Control and
Prevention, 32,000 overdose deaths involved drugs in the drug
categories that include methamphetamine and cocaine in 2019, an
increase of over 700%. The sharp increase has led some to refer to
stimulant overdoses as the ``fourth wave'' of the current drug
addiction crisis in America following the rise of opioid-related deaths
involving prescription opioids, heroin, and fentanyl-related
substances. Methamphetamine is highly addictive and there are no FDA-
approved treatments for methamphetamine and other stimulant use
disorders. The Committee continues to support NIDA's efforts to address
the opioid crisis, has provided continued funding for the HEAL
Initiative, and supports NIDA's efforts to combat the growing problem
of methamphetamine and other stimulant use and related deaths.
Barriers to Research. The Committee is concerned that restrictions
associated with Schedule I of the Controlled Substance Act which
effectively limits the amount and type of research that can be
conducted on certain Schedule I drugs, especially opioids, marijuana or
its component chemicals and new synthetic drugs and analogs. At a time
when we need as much information as possible about these drugs and
antidotes for their harmful effects, we should be lowering regulatory
and other barriers to conducting this research. The Committee
appreciates NIDA's completion of a report on the barriers to research
that result from the classification of drugs and compounds as Schedule
I substances including the challenges researchers face as a result of
limited access to sources of marijuana including dispensary products.
COVID Pandemic and Impact on Substance Use Disorders. The Committee
is acutely aware of the risks that the ongoing COVID-19 pandemic poses
to individuals with substance use disorders. According to the Centers
for Disease Control and Prevention, drug overdose deaths accelerated
during the pandemic which saw over 81,000 drug overdose deaths in the
United States in the 12 months ending in May 2020, the highest number
of overdose deaths ever recorded in a 12-month period. Moreover,
research supported by the National Institute on Drug Abuse found that
individuals with substance use disorders are at increased risk for
COVID-19 and its more adverse outcomes. The Committee commends NIDA for
conducting research on the adverse impact of the pandemic on SUDs and
encourages the Institute to expand its research on these issues.
Raising Awareness and Engaging the Medical Community in Drug Abuse
and Addiction Prevention and Treatment. Education is a critical
component of any effort to curb drug use and addiction, and it must
target every segment of society, including healthcare providers
(doctors, nurses, dentists, and pharmacists), patients, and families.
Medical professionals must be in the forefront of efforts to curb the
opioid crisis. The Committee continues to be pleased with the NIDAMED
initiative, targeting physicians-in-training, including medical
students and resident physicians in primary care specialties (e.g.,
internal medicine, family practice, and pediatrics). NIDA should
continue its efforts in this area, providing physicians and other
medical professionals with the tools and skills needed to incorporate
substance use and misuse screening and treatment into their clinical
practices. The Committee recommends that NIDA increase its support for
the education of scientists and practitioners to find improved
prevention and treatments for substance use disorders as the Institute
has done for the COVID-19 pandemic.
Marijuana Research. The Committee is concerned that marijuana
policies on the federal level and in the states (medical marijuana,
recreational use, etc.) are being changed without the benefit of
scientific research to help guide those decisions. NIDA is encouraged
to continue supporting a full range of research on the health effects
of marijuana and its components, including research to understand how
marijuana policies affect public health.
Electronic Cigarettes. The Committee understands that electronic
cigarettes (e-cigarettes) and other vaporizing equipment are
increasingly popular among adolescents, and requests that NIDA continue
to fund research on the use and consequences of these devices.
In addition, we request the following report language within the
Office of the Director account:
The HEALthy Brain and Child Development (HBCD) Study. The Committee
recognizes and supports the NIH HEALthy Brain and Child
Development Study, which will establish a large cohort of
pregnant women from regions of the country significantly
affected by the opioid crisis and follow them and their
children for at least 10 years. This knowledge will be critical
to help predict and prevent some of the known impacts of pre-
and postnatal exposure to drugs or adverse environments,
including risk for future substance abuse, mental disorders,
and other behavioral and developmental problems. The Committee
recognizes that the HBCD Study is supported in part by the NIH
HEAL Initiative, and NIH Institutes, Centers, and Offices
(ICOs), including OBSSR, ORWH, NIMHD, NIBIB, NIMHD, NIEHS,
NICHD, NINDS, NIAAA, NIMH, and NIDA, and encourages other NIH
ICOs to support this important study.
Substance use disorders (SUD) are costly to Americans; it ruins
lives, while tearing at the fabric of our society and taking a
financial toll on our resources. Over the past three decades, NIDA-
supported research has revolutionized our understanding of SUD as a
chronic, often-relapsing brain disease -this new knowledge has helped
to correctly emphasize the fact that SUD is a serious public health
issue that demands strategic solutions.
NIDA supports a comprehensive research portfolio that spans the
continuum of basic neuroscience, behavior and genetics research through
medications development and applied health services research and
epidemiology. While supporting research on the positive effects of
evidence-based prevention and treatment approaches, NIDA also
recognizes the need to keep pace with emerging problems. We have seen
encouraging trends in strategies to address these problems, but areas
of continuing significant concern include the recent increase in
fatalities due to heroin and synthetic fentanyl, as well as continued
illicit use of prescription opioids. Our knowledge of how drugs work in
the brain, their health consequences, how to treat people with SUDs,
and what constitutes effective prevention strategies has increased
dramatically due to research. However, because the number of
individuals who are affected is still rising, we need to continue the
work until this disease is both prevented and eliminated from society.
We understand that the FY2022 budget cycle will involve setting
priorities and accepting compromise, however, in the current climate we
believe a focus on substance use disorders deserves to be prioritized
accordingly. Thank you for your support for the National Institute on
Drug Abuse.
______
Prepared Statement of the Congressional Fire Services Institute
Dear Chair Murray and Ranking Member Blunt,
On behalf of the nation's fire and emergency services, we write to
urge your support for a vital program addressing the health and safety
of our nation's firefighters. As you consider the Fiscal Year (FY) 2022
Labor, Health and Human Services, Education, and Related Agencies
Appropriations bill, we urge you to fully fund the National Firefighter
Registry at the authorized level of $2.5 million. We very much
appreciate the program being funded at this level in FY2021 and we ask
that it be maintained this year.
During the 115th Congress, both the House and Senate unanimously
approved the Firefighter Cancer Registry Act (P.L. 115-194). The
bipartisan legislation created a specialized national registry to
provide researchers and epidemiologists with the tools and resources
needed to improve research collection activities related to the
monitoring of cancer incidence among firefighters.
Studies have indicated a strong link between firefighting and an
increased risk of several major cancers. However, certain studies
examining cancer risks among firefighters have been limited by the
availability of important data and relatively small sample sizes that
have an underrepresentation of women, minorities, and volunteer
firefighters. As a result, public health researchers are unable to
fully examine and understand the broader epidemiological cancer trends
among firefighters. The National Firefighter Registry is an important
resource to better understand the link between firefighting and cancer,
potentially leading to better prevention and safety protocols.
Thank you for your consideration, and your continued leadership and
support for America's fire and emergency services.
Sincerely,
Congressional Fire Services Institute
International Association of Arson Investigators
International Association of Fire Chiefs
International Association of Fire Fighters
International Fire Service Training Association
International Society of Fire Service Instructors
National Fallen Firefighters Foundation
National Fire Protection Association
National Volunteer Fire Council
[This statement was submitted by Michaela Campbell, Director of
Government Affairs, Congressional Fire Services Institute.]
______
Prepared Statement of the Consortium of Social Science Associations
On behalf of the Consortium of Social Science Associations (COSSA),
I offer this written testimony for inclusion in the official committee
record. For fiscal year (FY) 2022, COSSA urges the Committee to
appropriate:
--$46.1 billion for the National Institutes of Health;
--$10 billion for the Centers for Disease Control and Prevention,
including $200 million for the National Center for Health
Statistics;
--$500 million for the Agency for Healthcare Research and Quality;
--$800 million for the Bureau of Labor Statistics;
--At least $700 million for the Institute of Education Sciences; and
--$151.4 million for the Department of Education's International
Education and Foreign Language programs.
First, allow me to thank the Committee for its long-standing,
bipartisan support for scientific research. Strong, sustained funding
for all U.S. science agencies is essential if we are to make progress
toward improving the health and economic competitiveness of the nation.
As you know, the need for increased investment in science has become
even more pronounced by the disruptions caused over the past year by
the COVID-19 pandemic.
national institutes of health
COSSA joins more than 360 organizations in support of $46.1 billion
for the National Institutes of Health (NIH) in FY 2022. COSSA
appreciates the Subcommittee's leadership and its long-standing
bipartisan support of NIH, especially during difficult budgetary times.
However, recent public health events continue to underscore the need
for additional investment.
To be truly transformative, NIH will need to continue to embrace
research from a wide range of scientific disciplines, including the
social and behavioral sciences. The Office of Behavioral and Social
Sciences Research (OBSSR), housed within the Office of the NIH
Director, coordinates basic, clinical, and translational research in
the behavioral and social sciences in support of the NIH mission, and
co-funds highly rated grants in the behavioral and social sciences in
partnership with individual institutes and centers. Unfortunately,
OBSSR's budget has been held roughly flat for several years despite the
sizable increases to the NIH budget. Knowledge about contagion and
social influences on health are needed now more than ever. In addition,
understanding behavioral influences on health is needed to battle the
leading causes of morbidity and mortality, namely, obesity, heart
disease, cancer, AIDS, diabetes, age-related illnesses, accidents,
substance abuse, and mental illness. We urge the Senate to emphasize
support for OBSSR and encourage NIH to increase the Office's budget in
FY 2022.
centers for disease control and prevention
COSSA urges the Subcommittee to appropriate $10 billion for the
Centers for Disease Control and Prevention (CDC), including $200
million for CDC's National Center for Health Statistics (NCHS). Social
and behavioral science research plays a crucial role in helping the CDC
carry out its mission by informing the CDC's behavioral surveillance
systems, public health interventions, and health promotion and
communication programs that help protect Americans and people around
the world from disease. One needs only to look at the varied responses
across different communities to COVID-19 guidance and policies
surrounding social distancing, mask-wearing, and vaccination to
understand the critical role understanding the social aspects of public
health plays in keeping Americans safe and healthy. As the Department
of Health and Human Services' principal statistical agency, NCHS
produces data on all aspects of our health care system, including
opioid and prescription drug use, maternal and infant mortality,
chronic disease prevalence, health care disparities, emergency room
use, health insurance coverage, teen pregnancy, and causes of death. As
a result of the rising costs of conducting surveys and years of flat or
near-flat funding, NCHS has had to focus nearly all of its resources on
continuing to produce the high-quality data that communities across the
country rely on to understand their health. Additional funding would
allow NCHS to respond to rising costs, declining response rates, and an
ever-more complex health care system and capitalize on opportunities
surrounding advances in statistical methodology, big data, and
computing to produce better information more quickly and efficiently,
while reducing the reporting burden on local data providers.
agency for healthcare research and quality
COSSA urges the Subcommittee to appropriate $500 million for the
Agency for Healthcare Research and Quality (AHRQ), which would allow
AHRQ to rebuild portfolios terminated as a result of years cuts and
expand its research and training portfolio to address our nation's
pressing and evolving health care challenges. AHRQ funds research on
improving the quality, safety, efficiency, and effectiveness of
America's health care system. It is the only agency in the federal
government with the expertise and explicit mission to fund research on
improving health care at the provider level (i.e., in hospitals,
nursing homes, and other medical facilities). Its work is
complementary--not duplicative--of other HHS agencies and requires
robust support, especially given the critical role hospitals and group
care settings have played in the COVID-19 pandemic.
bureau of labor statistics
COSSA urges the Subcommittee to appropriate $800 million for the
Bureau of Labor Statistics (BLS) for its core programs. BLS produces
economic data that are essential for evidence-based decision-making by
businesses and financial markets, federal and local officials, and
households faced with spending and career choices. The BLS, like every
federal statistical agency, must modernize in order to produce the gold
standard data on jobs, wages, skill needs, inflation, productivity and
more that our businesses, researchers, and policymakers rely on so
heavily. The requested funding level would allow BLS to continue to
support evidence-based policymaking, smart program evaluation, and
confident business investment.
institute of education sciences
COSSA requests at least $700 million for the Institute of Education
Sciences (IES) in FY 2022. Within the Department of Education, IES
supports research and data to improve our understanding of education at
all levels, from early childhood and elementary and secondary
education, through higher education. Research further examines special
education, rural education, teacher effectiveness, education
technology, student achievement, reading and math interventions, and
many other areas. IES-supported research has improved the quality of
education research, led to the development of early interventions for
improving child outcomes, generated and validated assessment measures
for use with children, and led to the establishment of the What Works
Clearinghouse for education research, highlighting interventions that
work and identifying those that do not. With increasing demand for
evidence-based practices in education, adequate funding for IES is
essential to support studies that increase knowledge of the factors
that influence teaching and learning and apply those findings to
improve educational outcomes.
international education and foreign language programs
The Department of Education's International Education and Foreign
Language programs play a major role in developing a steady supply of
graduates with deep expertise and high-quality research on foreign
languages and cultures, international markets, world regions, and
global issues. COSSA urges a total appropriation of $151.4 million
($134.3 million for Title VI and $17.1 million for Fulbright-Hays),
which would help make up for lost investment and purchasing power over
many years of flat-funding. In addition to broadening opportunities for
students in international and foreign language studies, such support
would also strengthen the nation's human resource capabilities in
strategic areas of the world that impact our national security and
global economic competitiveness.
Thank you for the opportunity to present this testimony on behalf
of the social and behavioral science research community.
[This statement was submitted by Submitted by Wendy Naus, Executive
Director, Consortium of Social Science Associations.]
______
Prepared Statement of the Council of Academic Family Medicine
The member organizations of the Council of Academic Family Medicine
(CAFM) are pleased to submit testimony on behalf of programs under the
jurisdiction of the Health Resources and Services Administration (HRSA)
and the Agency for Healthcare Research and Quality (AHRQ). CAFM
collectively includes family medicine medical school and residency
faculty, community preceptors, residency program directors, medical
school department chairs, and research scientists. We urge the
Committee to appropriate (1) at least $125 million for the HRSA Primary
Care Training and Enhancement (PCTE) program and (2) at least $500
million for AHRQ, specifically funding $5 million to AHRQ's Center for
Primary Care Research.
More than 44,000 primary care physicians will be needed by 2035;
however, current primary care production rates will not meet demand,
according to the authors of Annals of Family Medicine (Petterson, et al
Mar/Apr 2015). The PTCE programs and AHRQ research enhance our nation's
workforce and health infrastructure, creating better health outcomes
and lower costs.
Primary Care Training and Enhancement--Title VII
The PCTE Program (Title VII, Section 747 of the Public Health
Service Act) has a long history of funding training of primary care
physicians. As experimentation with new or different models of care
continues, departments of family medicine and family medicine residency
programs will rely further on Title VII, Section 747 grants to help
develop curricula and research training methods for transforming
practice delivery. Future training needs include: training in new
clinical environments that include integrated care with other health
professionals (e.g. behavioral health, care coordination, nursing, oral
health); development and implementation of curricula to give trainees
the skills necessary to build and work in inter-professional teams that
include diverse professions; and development and implementation of
curricula to develop leaders and teachers in practice transformation.
We are concerned that the President's FY2022 Budget did not include
additional funding for the Primary Care Training and Enhancement
program. Additional funding for the PCTE program can help address many
of the failings and flaws of the current primary health care and public
health infrastructure that have been identified in the COVID-19
pandemic. For example, additional funding is needed for both
residencies and departments to help address faculty retention, public
health competencies, recruit and retain students into primary care,
develop new, innovative curriculum related to the pandemic and to
address segmented primary care workforce to reduce delivery system
division and increase full scope primary care providers.
A 2021 report by The National Academy of Science, Engineering and
Medicine (NASEM) on Implementing High-Quality Primary Care: Rebuilding
the Foundation of Health Care, identified the problems with under-
funding Title VII programs finding that despite the demonstrably better
patient outcomes that have resulted from Title VII investments, Title
VII funding remains only a tiny fraction of the total GME funding;
reduced to less than 10% since the 1960s. Primary care training grants
under Title VII are vital to the continued development of a workforce
designed to care for the most vulnerable populations, including
concerns related to health equity.
We urge your continued support for this program and an increase in
funding levels to $125 million in FY 2022 to allow for a robust
competitive funding cycle to fund new initiatives to help address
issues related to the COVID-19 pandemic, and a shortage of primary care
providers. An example of the type of program supported by the PCTE
program was the Danbury and Griffin Hospital programs in Connecticut
who used it to develop innovative programs and curricula related to
interdisciplinary training.
Agency for Health Care Research and Quality (AHRQ)
Primary care clinical research (PCR) is a core function of AHRQ.
Primary care research includes: translating science into patient care,
better organizing health care to meet patient and population needs,
evaluating innovations to provide the best health care to patients, and
engaging patients, communities, and practices to improve health. AHRQ
has proved to be uniquely positioned to support best practice primary
care research and to help disseminate the research nationwide. However,
reduced levels of AHRQ funding in the past have exacerbated disparities
in funding primary care research. Important primary care research
initiatives have been unfunded in recent years such as research for
patients with Multiple Chronic Conditions (MCC) and the statutorily
authorized Center for PCR.
AHRQ is in a unique position to further PCR as well as the
implementation science to identify how to deploy new knowledge into the
hands of primary care providers and systems in communities. However,
more funding, above FY2021 levels, is needed to accomplish these goals.
For this reason, we are supporting additional overall funding increases
for FY 2022 to $500 million as well as specific funding for the Center
for Primary Care Research of $5 million to help coordinate and direct
primary care research funding at AHRQ. We hope additional funding will
continue and expand the following goals: (1) development of clinical
primary care research and researchers (2) real-world application of
evidence, (3) the process of practice and health system transformation,
(4) how high functioning primary care systems and practices should
look, (5) how primary care practices serving rural and other
underserved populations adapt and survive, while expanding their
ability to address health inequities, and (6) how health extension
systems serve as connectors of research institutions with practices and
communities.
President's FY2022 Budget Request for AHRQ
The recently released Fiscal Year 2022 Budget request includes a
major, new primary care initiative at AHRQ totaling $10 million. The
Congressional Justification (CJ) for AHRQ, reminds Congress that ``AHRQ
is the only PHS agency that supports clinical, primary care research
which includes translating science into patient care and better
organizing health care to meet patient and population needs.''
We support the CJ's assertion that ``primary care research is
critical to AHRQ's mission to make health care safer, higher quality,
more accessible, equitable, and affordable.'' We are also pleased that
the primary care initiative discussed in the CJ would support the work
of practice-based research networks (PBRNs.) In order to fulfill the
promise of this initiative, we recommend a related initiative--that at
least $5 million of the amount Congress provides to AHRQ be directed to
the statutorily authorized Center for Primary Care Research within the
Agency. This would support the needed coordination and prioritization
of primary care research investments within AHRQ, as two recent
national studies have recommended.
Two Recent National Studies Support this Funding Request
In 2020, the RAND Corporation published a report appropriated by
Congress and commissioned by AHRQ that assessed federally funded PCR
since 2012 regarding gaps and to recommend improvements. The report
emphasized the significant role AHRQ plays in PCR. RAND made several
recommendations, including to provide targeted funds to create a proper
hub for federal PCR. This is important because PCR is a distinct
science that differs from health services research. With $5 million in
dedicated funds for PCR, AHRQ could prioritize and coordinate
investments in PCR directly improving the health and wellbeing of
Americans. In 2021, The NASEM report on High Quality Primary Care
concurs with RAND's assessment on the importance of targeted funding
for PCR and recommends prioritization of funding for AHRQ's Center for
Primary Care Research.
A real-world example of successful AHRQ work supporting primary
care practice and patient safety is funding to the Oregon Health &
Science University, the Rural Practice-based Research Network helped
lead Healthy Hearts Northwest by recruiting 100 primary care practices
to develop team-based quality improvement infrastructure improvements
in small to medium-size practices. The Evidence Now Initiative operated
as health extension agents in Oregon's frontier communities. In another
example, AHRQ funding has allowed the University of Missouri to build
infrastructure for patient-centered outcomes research in three arenas.
The first study evaluated the advantages and disadvantages of
endovascular vs. open surgery for legs with inadequate blood flow. The
second project focused on improved discharge plans from skilled nursing
facilities through improved primary care connections. Missouri
partnered with the AAFP to create a national research network to
improve chronic pain for the third project.
In conclusion, we support increased funding for AHRQ at the level
of $500 million for FY 2021 which would support important primary care
and health services research efforts. We also support $5 million in new
funding for the Center for Primary Care Research. CAFM looks forward to
working with the Subcommittee to protect HRSA primary care programs and
AHRQ--both entities enhance our nation's primary care workforce and
infrastructure.
______
Prepared Statement of the Covenant House International
Dear Chairwoman Murray and Ranking Member Blunt:
Covenant House is the largest charitable organization in North and
Central America housing and serving children and youth facing
homelessness including survivors of human trafficking. Every year, we
reach tens of thousands of young people in 33 cities in six countries:
The United States, Guatemala, Honduras, Mexico, Nicaragua, and Canada.
Since our founding, we have reached more than 1.5 million children and
youth. Our high-quality programs are designed to empower young people
to overcome adversity, today and in the future.
Covenant House strongly supports the Runaway and Homeless Youth and
Trafficking Prevention Act (RHYTPA) administered by HHS's ACF and
McKinney-Vento Act's Education for Homeless Youth program (ECHY)
administered by Department of Education, which have both proven to be
effective in addressing child and youth homelessness. Covenant House is
requesting significant investment increases in these main federal
programs reaching children and youth facing homelessness.
Across our 23 U.S. communities which currently benefit from these
programs, in FY20:
--9,300 youth were served through street outreach programs. 7,400
youth were served in residential programs and 6,400 youth were
reached in drop-in centers and non-residential programs.
--49 percent of youth served by Covenant House across the United
States reported a mental health diagnosis, nearly 50 percent
had not yet completed high school, and 33 percent have a
history of foster care.
--Over 80% of youth served were of young people of color, including
Black/African American and Latino. And based on our
groundbreaking research reported out in 2018:
--1 in 5 of youth interviewed reported being survivors of
trafficking, and
--22% of youth interviewed were offered money for sex on their
first night experiencing homelessness.
In addition to meeting basic needs, RHYTPA provides youth with
housing stability and the necessary supports of mental health
counseling, employment and training, education, and physical health
services-needed to ensure youth remain stable, health and connected to
caring adults. EHCY grants provide school stability and support to
proactively mitigate the risk of homelessness--more critical than ever
as schools recover from COVID. Covenant House also supports the Runaway
and Homeless Youth's Street Outreach program to outreach and engage
youth who are in unsafe living conditions.
Covenant House has received $4.8 million in RHYTPA grants since
2017 in regular grants and $861,000 from the CARES Act emergency
funding. While this funding has been critical to our network
maintaining services, the overall annual Runaway and Homeless Youth
program does not have nearly enough resources to meet the demand in the
field. Last year, there were 545 applications to the program but only
179 awards granted (less than 33 percent). The vast majority of these
applications scored at the highest level and were worthy of funding if
resources were available. As a result of this unmet demand, RHYA
programs often turn away thousands of youth each year due to lack of
available beds, leaving these children vulnerable without safe and
stable housing and increasing their risk of predation and harm.
As for EHCY, even prior to the COVID-19 pandemic, the U.S.
Department of Education reported record numbers of youth homelessness
in the 2018-2019 academic year, with more than 1.4 million youth
experiencing homelessness. The COVID-19 pandemic has only exacerbated
this issue. With only a quarter of school districts receiving support
through the EHCY program in a given year, it is clear that homeless
children and youth are still under-identified and face significant
barriers to school enrollment and education continuity.
The President's FY22 budget requested $145 million for RHYTPA
consolidated programs, including the Street Outreach Program.
--Covenant House is joining with our coalition partners in requesting
$300 million for RHYTPA to meet the basic safety and housing
needs of youth experiencing or at risk of homelessness.
The President's FY22 budget requested level funding at $106 million
for the McKinney-Vento Education for Homeless Children and Youth Act
program.
--Covenant House is joining with our coalition partners in requesting
$300 million for EHCY.
For additional information please contact Lori Maloney, SVP of
Advocacy at Covenant House, at [email protected] or Sally
Schaeffer, consultant, at [email protected].
[This statement was submitted by Kevin Ryan, President and CEO,
Covenant House International.]
______
Prepared Statement of the Creutzfeldt-Jakob Disease Foundation
Chairwoman Murray, Ranking Member Blunt, and Members of the
Subcommittee:
We appreciate the opportunity to submit this testimony in strong
support for funding of the crucial prion disease work being undertaken
by the Centers for Disease Control and Prevention in partnership with
public health agencies around the country and the National Prion
Disease Pathology Surveillance Center (NPDPSC). We request
Congressional support in increasing the Prion Disease Surveillance
appropriation through the CDC, Emerging and Zoonotic Infectious
Diseases, by $1 million, for a total of $7.5 million.
Overview
Creutzfeldt-Jakob Disease (CJD), is a rare,100% fatal, degenerative
brain disease that causes rapidly progressive dementia. CJD is
transmissible and presently has no treatment or cure. Approximately 1
in 6,200 individuals will die from this disease in their lifetime;
however, the unreported and undiagnosed number of cases remains
unclear.
CJD is caused by the presence of an abnormal ``prion'' protein in
the brain and is known as a prion disease. CJD/prion disease
surveillance receives modest support through the Centers for Disease
Control and Prevention (CDC). We need your support to strengthen and
continue the coordination of CJD and other prion disease surveillance
activities and to assure the safety of the American public.
Variant CJD (vCJD), and Bovine Spongiform Encephalopathy (BSE)
One form of this disease in humans, variant CJD (vCJD), is known to
be caused by ingesting tissues in beef contaminated with Bovine
Spongiform Encephalopathy (BSE), commonly known as ``mad cow'' disease.
The most recent U.S. case of variant CJD was announced in 2013 and
confirmed by the National Prion Disease Pathology Surveillance Center
(NPDPSC) in 2014. Limited BSE testing by the USDA adds another layer to
the already deepening concerns regarding possible risks to humans. In
recent years, the USDA has decreased random testing for BSE from 40,000
to 25,000 tests per year (12,719 tests in 6 months, or 1 test per 3,302
live cows). Hence, surveillance of BSE in this country is largely
dependent on demonstrating the lack of transmission to humans through
human disease surveillance. The vCJD case identified by NPDPSC in 2014
exemplifies the persistent risk for vCJD acquired in unsuspected
geographic locations and highlights the need for continuing prion
disease surveillance and awareness to prevent further dissemination of
vCJD. The two most recent cases of vCJD in Europe are believed to be
due to occupational exposure and several cases of vCJD have been
transmitted between individuals via blood transfusions. Hence, vCJD
risk is not confined to eating contaminated food.
Chronic Wasting Disease (CWD)
Emerging laboratory data show that Chronic Wasting Disease (CWD), a
naturally occurring prion disease of deer and elk, could potentially
transmit to humans and other mammals, posing a new threat to public
health. Human surveillance through brain tissue examination is the only
way to definitely diagnose human prion diseases, determine their
origin, and determine whether the spread of CWD found in elk and deer
in 26 states in the U.S. and in 3 Canadian provinces has become a human
risk. A study in progress has shown that CWD was transmitted to
macaques (primates that are genetically similar to humans) by feeding
them contaminated deer meat. Unlike the BSE outbreak in cattle, CWD
prions are highly infectious and the disease transmits by contact and
through contaminated environment, including soil and plants, in free
ranging animals. Additionally, multiple lines of experimental evidence
indicate that sheep and cows are susceptible to CWD. Since CWD has been
proven to cross several species barriers, this opens up the possibility
of oral transmission to humans as well, either directly by eating
contaminated venison or indirectly through infected domestic animals.
Continued prion disease surveillance, particularly through examination
of human brain tissue, is imperative to evaluate whether CWD has or can
spread to humans.
The NPDPSC, funded by the CDC and located at Case Western Reserve
University in Cleveland, Ohio, is our line of defense against the
possibility of an undetected U.S. human prion disease epidemic as
experienced in the United Kingdom.
Prion disease surveillance is funded at $6.5 million/year. That
figure has increased by just $500,000 over the past six years, despite
increasing costs of surveillance. Expenses have since risen for the
resources required to perform adequate surveillance such as increasing
number of cases as expected by the aging American population,
increasing autopsy costs over time, screening for COVID19, and taking
extra precautions necessary for COVID19. Without an increase in funding
commensurate with these increased expenses, surveillance will be
compromised.
Request:
We ask for Congressional support in increasing prion disease
surveillance's appropriation by $1 million, for a total of $7.5
million. This would allow the NPDPSC to meet increasing autopsy costs
and continue to develop more efficient detection methods while
providing an acceptable level of prion surveillance. Reduction of
funding or maintaining static funding to the NPDPSC would eliminate an
important safety net to U.S. public health, making the U.S. the only
industrialized country lacking prion surveillance, which in turn would
jeopardize the export of U.S. beef. The increase in funding would allow
the NPDPSC to expand its scope to address the growth in CWD among deer
and elk, and explore whether CWD could spread to humans. Additionally,
increasing prion disease surveillance in the U.S. increases
surveillance at the national (CDC) and state (state public health
departments) levels, which has been severely affected by competing
concerns within the CDC division (e.g., COVID19).
Background:
The NPDPSC is funded entirely by the CDC from funds allocated by
Congress. The CDC traditionally keeps approximately half of the
appropriation for national surveillance projects and funding prion
disease surveillance at the state level.
Increasing the appropriation from $6.5M to $7.5M will allow the
NPDPSC to persist and continue to develop more efficient detection
methods while providing an acceptable level of prion disease
surveillance. Acceptable national surveillance is not possible at a
lower level of funding. The requested $1M addition to the appropriation
(total of $7.5M) would enable the NPDPSC to maintain appropriate
surveillance, tissue collection, diagnostics and diagnostic test
development of prion disease cases from CWD endemic states to determine
whether CWD is transmissible to humans and if so, to what extent this
poses to public health (e.g., transmission risks from human to human).
The National Prion Disease Pathology Surveillance Center is the
only laboratory based organization in the U.S. that monitors human
prion diseases and is able to determine whether a patient acquired the
disease through the consumption of prion contaminated beef (``mad cow''
disease) or meat from elk and deer affected by chronic wasting disease
(CWD).
The NPDPSC also monitors all cases in which a prion disease might
have been acquired by infected blood transfusion, from the use of
contaminated surgical instruments, or from contaminated human growth
hormone. Because standard hospital sterilization procedures do not
completely inactivate prions that transmit the disease, these incidents
put a number of patients under unnecessary risk and require costly
replacement of contaminated surgical equipment.
The NPDPSC also plays a decisive role in resolving suspected cases
or clusters of cases of food-acquired and medically transmitted prion
disease that are often magnified by the media, stirring intense public
alarm. To date, the NPDPSC has examined over 7,500 suspected incidents
of suspected prion diseases and has definitely confirmed presence and
type of prion disease in more than 4,600 cases.
The NPDPSC is the primary line of defense in safeguarding U.S.
public health against prion diseases because the U.S., unlike other BSE
affected countries such as the UK, the European Union, and Japan, does
not have a sufficiently robust animal prion disease surveillance
system.
The NPDPSC offers assurances, to countries that import (or are
considering importing) meat from the United States, that the U.S. is
free of indigenous human cases of ``mad cow'' disease. In the past,
South Korean and Chinese health officials resumed importation of U.S.
beef to their country after a visit to the NPDPSC provided assurances
regarding rigorous human prion surveillance.
Since its inception in 1997, the NPDPSC has collected and stored
over 7,500 brains and many more samples of cerebrospinal fluid from
cases of suspected prion disease, making it the largest prion disease
biobank in the world. Increased funding is required to continue to
preserve these precious specimens for future international research
efforts as well as to serve as reference materials to evaluate
potential emerging prion diseases (e.g., chronic wasting disease).
Thank you for the opportunity to submit this testimony.
[This statement was submitted by Deborah R. Yobs, President/
Executive Director, Creutzfeldt-Jakob Disease Foundation.]
______
Prepared Statement of Crowley Amanda Peel deg.
Prepared Statement of Amanda Peel Crowley
Madam Chairwoman,
It is an honor to provide testimony to the Subcommittee on behalf
of the thousands of children across the country who have had their
lives turned upside down by Childhood Post-Infectious Neuroimmune
Disorders, or CPINDs. These medical conditions develop after illnesses
and are thought to reflect a misguided immune system and inflammatory
response to infection.
I ask that the Committee consider providing language in the
Committee's fiscal year 2022 report under the Department of Health and
Human Services, Office of the Director, Multi-Institute Research Issues
account, directing the National Institutes of Health (NIH) to identify
research priorities for CPINDs, including PANDAS and PANS, and to
investigate these disorders across disciplines, including neurobiology,
neurology, immunology, rheumatology, infectious disease, and mental
health. We are also asking that NIH report to the Committee on the
incidence, causes, diagnostic criteria, and treatment of these
conditions, especially including ways to advance understanding and
improve clinical care. This year, there is an urgent need to better
understand post-infectious conditions because of COVID-19 and for NIH
to prioritize and fund CPINDs' research.
In 2020, the world woke up to the notion of post-infectious
complications as we witnessed the impact of COVID-19 in daily reports
of patients with chronic and delayed-onset symptoms. Growing research
data has confirmed the association of debilitating psychiatric and
neurological symptoms with the SARS-CoV-2 virus in both adults and
children. A significant number of children have developed neurological
symptoms with COVID-19 infection, including altered mental status. New
research describing late-developing psychiatric changes, including
anxiety, OCD, and aggression, in children following COVID-19 infection
concludes that SARS-CoV-2 should in fact be considered in the
differential diagnosis of a CPIND known as Pediatric Acute-onset
Neuropsychiatric Syndrome (PANS). The time has come to connect the
dots--it is more than clear that infections lead to neurological and
psychiatric symptoms. Robust research is under way, and we ask for
CPINDs to be included. We firmly believe that investigations into the
mechanism of CPINDs will have a far-reaching impact.
Children with CPINDs experience the onset of debilitating
neuropsychiatric and behavioral disorders following illness such as
influenza, ``strep throat,'' and COVID-19. Studies indicate that
misdirected antibodies and immune cells assault structures in a region
of the brain involved in emotion, cognition, and movement. It is not
surprising that, as in well-described types of autoimmune encephalitis,
the symptoms signal dysfunction is this same brain region.
Two neuroimmune conditions, Pediatric Autoimmune Neuropsychiatric
Disorders Associated with Streptococcal Infections (PANDAS) and
Pediatric Acute-onset Neuropsychiatric Syndrome (PANS), were described
in 1998 and 2010, respectively. PANDAS is believed to be a variation of
rheumatic fever. Rheumatic fever can develop if streptococcal
infections are not treated properly, setting off an immune response
where antibodies and immune cells attack the heart, kidneys, joints, or
brain. The term PANS was developed as a broader diagnosis than PANDAS,
with the same symptoms arising from infections other than strep. These
disorders are often misdiagnosed as purely psychiatric, and early
opportunities to treat medically, by targeting the underlying
infections, inflammation, and immune dysfunction, are missed or delayed
leading to escalating severity and associated costs.
Families like mine are blindsided when children's personalities
completely change, and our kids are suddenly overcome by crippling
fears, obsessive thinking, compulsive behaviors and tragically,
suicidal thoughts. Some children are unable to separate from parents
and many cannot attend school, or even leave the house. When children
are unable to participate in school, they often experience learning
impairments and significant academic declines. Previously successful
students now need special education services, including aides to
support their learning and behavior. Children who previously wrote
legibly have such serious declines that they are no longer able to hold
a pencil. Some children are beset by severe motor and vocal tics
leading to further educational and social challenges. There is no part
of life that escapes unscathed.
There are other serious physical consequences to illness in these
children. Some, as young as four or five, suddenly appear anorexic,
restricting their eating to near starvation because of worries about
contaminated food or fear of choking. In extreme cases, children have
to be placed on feeding tubes.
Children experience massive mood swings and fly into aggressive
rages, full of irrational explosive anger. Even seven- or eight-year-
old children can become suicidal, with an obsessive feeling that they
have to die. Several children have ended their lives, and many others
have been hospitalized when their symptoms become serious or life-
threatening.
All three of my children have PANDAS, and our family's journey is,
sadly, typical. Their stories illustrate the need for standardized
clinical care and for accurate early diagnosis and education concerning
risks to children and the many burdens on families, schools, and health
care systems.
My two older children acquired multiple misdiagnoses as their
behaviors and symptoms worsened over years. We finally arrived at the
true cause of their illness: an undiagnosed, untreated strep infection,
the same bacteria that causes a sore throat. When they received medical
treatment, they showed improvements far beyond traditional psychiatric
therapies.
My children also exemplify the contrast between early diagnosis and
misdiagnosis. My youngest child was treated successfully when her
symptoms were new, but my oldest children have suffered more serious
complications and required more extensive treatment. They have lost
critical time between the onset of their symptoms and medical
intervention that they cannot completely regain.
With delays in diagnosis and care, children are at risk for further
decline and potential long-term disability as their brain inflammation
remains untreated. As symptoms escalate, the burden on families,
healthcare systems, and schools grows exponentially. Caregivers endure
significant lost work time and out-of-pocket medical costs. Insurers
pay for emergency room visits and inpatient treatment, as well as
ongoing pharmacological and behavioral treatment to manage unlivable
symptoms. Educational systems face an enormous financial burden when
putting special education services into place for children who need
increased academic and behavioral support.
There is a significant lack of NIH funding to support research into
these disorders and to understand their true cost and prevalence. To
date, the avenues for identifying, treating, and tracking post-
infectious neuroimmune patients are minimally developed. Only through
targeted research can we determine why some children develop
psychiatric symptoms after infection, find diagnostic biomarkers, and
demonstrate which treatments are most effective. We cannot achieve this
alone. Action needs to be taken by NIH to increase funding for research
into the causes and treatments of these conditions.
This year my family faced not only the ongoing trauma of PANDAS,
but the horrors of COVID-19, first-hand. My father, who was in good
health, was diagnosed last August and just weeks later was fighting for
his life. He continues his long road to recovery, 10 months later. Like
my children, the lasting damage was not done by the infection itself,
but by the immune response. If we knew how to recognize and treat this
complication early, we would have vastly different outcomes, not just
for COVID-19 patients but for the thousands of children not in the
spotlight who have CPINDs.
I want my family's experience with these devastating post-
infectious conditions to help other families who are suffering. SARS-
CoV-2 highlights both a pressing need and an opportunity for
collaborative research across disciplines to better understand how
neuropsychiatric complications develop and to find tools and treatments
for early diagnosis and treatment. The world has rallied medicine and
science in an unprecedented way this year. Let us also widen the scope
to continue work on CPINDs, including PANDAS and PANS. The time to act
is now--funding research will be a vital next step for the health of
our country and the future of our children. Parents are doing all we
can to support our children. Won't you please join with us to help
solve this nationwide health crisis?
[This statement was submitted by Amanda Peel Crowley, Founding
Member,
Massachusetts Coalition for Pans/Pandas Legislation.]
______
Prepared Statement of the Cure Alzheimer's Fund
Chairwoman Murry, Ranking Member Blunt, and members of the Senate
Labor, Health & Human Services, Education, and Related Agencies (LHHSE)
Appropriations Subcommittee, I am Tim Armour, President and CEO of Cure
Alzheimer's Fund. I want to thank Congress for past funding for
Alzheimer's disease research at the National Institutes of Health
(NIH), and to submit this written testimony to respectfully request at
least an additional $289 million in Fiscal Year 2022 above the final
enacted amount for Fiscal Year 2021 for Alzheimer's disease research at
the NIH. Additionally, Cure Alzheimer's Fund respectfully requests at
least $560 million in total appropriations for the Brain Research
through Advancing Innovative Neurotechnologies (BRAIN) Initiative. The
BRAIN Initiative is playing an increasingly important imaging role in
the early detection and diagnosis of Alzheimer's disease.
Cure Alzheimer's Fund is a national nonprofit, based in
Massachusetts, that funds research with the highest probability of
preventing, slowing, or reversing Alzheimer's disease. Since its
founding more than 15 years ago, Cure Alzheimer's Fund has invested
more than $126 million in research through 530 grants in twenty-one
states.
With the sustained commitment this Subcommittee has shown to
Alzheimer's disease research at NIH, targeted investments into basic
research made by private organizations such as Cure Alzheimer's Fund,
have been leveraged into larger-scale research projects at NIH. An
analysis by Cure Alzheimer's Fund found that the close to $17 million
it invested in research in 2018, led to an additional investment of
close to $121 million by NIH in the next two years. This shows the
importance of continued and sustained investment for the Alzheimer's
disease research portfolio at NIH because discoveries happening today
will need to be funded in the future.
https://curealz.org/wp-content/uploads/2020/11/PV_Cure_Leverage_Annual
AppealInsert_R5V1.pdf
Without the ongoing commitment demonstrated by this Subcommittee,
investments made by private organizations, and the discoveries spurred
by these investments, would not be able to be further explored,
examined, and validated. The public-private partnership between groups
like Cure Alzheimer's Fund and NIH is vital to Alzheimer's disease
research because Cure Alzheimer's Fund can target investment in novel
research ideas, allow researchers to collect initial data and
strengthen their hypothesis, and then ``hand-off'' the project to NIH
for larger-scale investment and research that is beyond the scope of
Cure Alzheimer's Fund. The robust research portfolio at NIH allows this
continuum of research to continue and thrive.
Two concrete examples of this are the brain lymphatic system and
the role of the innate immune system in the development of Alzheimer's
disease. As I described in my written testimony last year, as far back
as 2010, Cure Alzheimer's Fund has supported research into the beta-
amyloid protein and its role in fighting infection. This was a novel
research concept that was not receiving federal support. However,
because of the investment made by Cure Alzheimer's Fund, the role of
the innate immune system and infection are now NIH research targets.
As Dr. Francis Collins, Director of the NIH, mentioned at a House
LHHSE Subcommittee NIH hearing on March 4, 2020, one of the most
promising areas of Alzheimer's disease research is the role of the
innate immune system in the development of Alzheimer's disease.
NIH has convened meetings (September 23-24, 2019) around the topic
of infection and viruses in the development of Alzheimer's disease.
This would not have happened without early investment in research and
the availability of larger-scale research funding made possible by this
Subcommittee.
https://curealz.org/news-and-events/abeta-may-have-beneficial-function-
as-part-of-the-innate-immune-system/
https://www.nia.nih.gov/about/naca/january-2020-directors-status-report
In the past, I have also highlighted the work of Dr. Jonathan
Kipnis and the role of the brain lymphatic system, and I want to again
highlight this research as an example of the importance of basic
research supported by Cure Alzheimer's Fund becoming a larger research
project at NIH.
In 2016, Cure Alzheimer's Fund supported research by Dr. Kipnis and
the role of Meningeal Lymphatics in cleansing the brain.
https://curealz.org/research/foundational-genetics/the-role-of-
meningeal-lymphatics-in-cleansing-the-brain-implications-for-
alzheimers-disease/
Cure Alzheimer's Fund's commitment to this research has continued while
the research has also been supported by NIH. NIH recently highlighted
this research in a press release at the end of April. Or five years
after Cure Alzheimer's Fund made its initial investment.
https://www.nia.nih.gov/news/brains-waste-removal-system-may-offer-
path-better-outcomes-alzheimers-therapy
Without Cure Alzheimer's Fund's first investment in 2016, and NIH's
larger-scale investment after that, this research would not have been
able to have been pursued so thoroughly. And this would not have been
possible without the sustained and continued commitment to Alzheimer's
disease research funding at NIH demonstrated by this Subcommittee.
As Cure Alzheimer's Fund continues to invest in research into novel
research targets, there are more opportunities for NIH to be able to
provide larger-scale research funding to help us better understand the
pathology of Alzheimer's disease.
Cure Alzheimer's Fund has supported research by Dr. Caleb Finch
into the role pollution and particulate matter play in the development
of Alzheimer's disease. The first investment Cure Alzheimer's Fund made
into this research was in 2014.
https://curealz.org/research/translational-research/air-pollution-and-
app-processing/
Last year, the National Academies of Sciences, Engineering, and
Medicine had a day-long symposium on Advancing the Understanding of
Chemical Exposures Impact Brain Health and Disease. Dr. Finch was a
presenter during this symposium.
https://www.nap.edu/read/25937/chapter/1
NIH is now supporting this research and it is becoming increasingly
important to not only Alzheimer's disease research, but environmental
justice research as well. We know that disadvantaged communities
experience higher rates of Alzheimer's disease; research like Dr.
Finch's is helping to identify environmental drivers like air-borne
pollutants.
Cure Alzheimer's Fund is supporting research into vascular
contributors to the development of Alzheimer's disease; African
Americans have higher risk of neurovascular issues that are risk
factors for Alzheimer's Disease as well as medical conditions of
concern in and of themselves.
https://curealz.org/research/amyloid/the-role-of-picalm-in-vascular-
clearance-of-amyloid-b-and-neuronal-injury/
https://curealz.org/research/foundational-genetics/neurobiological-
basis-of-cognitive-impairment-in-african-americans-deep-
phenotyping-of-older-african-americans-at-risk-of-dementia/
This is important research for both the understanding of
Alzheimer's disease and reducing health disparities for disadvantaged
communities. With sustained and continued support from this
Subcommittee, Cure Alzheimer's Fund will be able to continue to invest
in basic research knowing that NIH will have the necessary resources to
be able to provide larger-scale investment into these important
research topics.
Thank you for your continued support of Alzheimer's disease
research, and for the opportunity to submit this written testimony and
to respectfully request at least an additional $289 million above the
final enacted level in Fiscal Year 2021 for Fiscal Year 2022 for
Alzheimer's disease research at NIH, and at least $560 million in total
appropriations for the BRAIN Initiative. Cure Alzheimer's Fund has
worked closely with the Subcommittee in the past and looks forward to
being your partner as we work toward Alzheimer's disease research
having the necessary resources to end this awful disease.
Respectfully Submitted June 24, 2021.
[This statement was submitted by Timothy Armour, President and CEO,
Cure Alzheimer's Fund.]
______
Prepared Statement of Dave Purchase Project, the North American Syringe
Exchange Network, Tacoma Needle Exchange, and Coalition Partners
Chairwoman Murray, Ranking Member Blunt, and members of the
Subcommittee, my name is Dr. Paul LaKosky and I serve as the Executive
Director of Dave Purchase Project, the North American Syringe Exchange
Network (NASEN), and the Tacoma Needle Exchange in Tacoma, Washington.
I am pleased to submit testimony on behalf of these organizations and
as a member of a large coalition of public health, HIV, viral
hepatitis, and harm reduction organizations to urge Congress to
appropriate $120 million for the Infectious Diseases and the Opioid
Epidemic program at the Centers for Disease Control and Prevention
(CDC) at the Department of Health and Human Services (HHS) to save
lives and address the overdose crisis by supporting and expanding
access to syringe services programs (SSPs).
Named in honor of its late, pioneering founder, Dave Purchase, Dave
Purchase Project houses the nation's first legal syringe services
program, created in 1988 at the height of the HIV epidemic in the
United States. The program seeks to stop the spread of bloodborne
pathogens, such as HIV and hepatitis C, among people who use drugs and
to reduce the harm to individuals and communities associated with drug
use. Although initially intended to address the spread of HIV, Dave
Purchase Project now provides national leadership in its response to
the opioid crisis. It also facilitates syringe services in Tacoma and
throughout Pierce County, Washington.
Dave Purchase Project also houses the North American Syringe
Exchange Network (NASEN). In 1992, NASEN formed to support syringe
services programs (SSPs) and to expand the network of organizations and
individuals that advocate for these life-saving programs. NASEN is the
first and largest supplier of low-cost harm reduction resources in the
US. In 2020, NASEN acquired and distributed approximately $18 million
in harm reduction resources to the approximately 400 SSPs in the US,
Puerto Rico, and the US Virgin Islands. NASEN also provided support
valued at $25,000 to 28 newly emerging and/or struggling SSPs through
start-up grant packages. As the Executive Director of these
organizations, I am familiar with providing direct services to people
who use drugs in Washington State, and with the significant gaps and
need for resources and services nationwide.
The United States is experiencing an urgent and unprecedented drug
overdose crisis, with approximately 100,000 overdose deaths expected to
be counted in 2020 and potentially more in 2021. This would be an
increase of more than 40% over the previous record year of 2019.
According to the Washington State Department of Health, overdose deaths
accelerated in 2020, increasing by 38% in the first half of 2020 as
compared to the first half of 2019.
Overdose deaths have increased more dramatically among Black people
and communities of color. From 2015 to 2018, overdose deaths among
African Americans more than doubled (by 2.2 times) and among Hispanic
people increased by 1.7 times while increasing among white, non-
Hispanic people by 1.3 times. In Washington State, the increase in
overdose deaths was highest among groups already dealing with
inequitable health outcomes: American Indian/Alaska Natives, Hispanic/
Latinx, and Black people. While overdose deaths affect all racial and
ethnic groups, American Indian and Alaskan Native (AI/AN) populations
are disproportionately impacted in Washington State. The death rate
among AI/AN is more than 3 times the rate of overdose in the state (9.6
per 100,000). Preliminary 2019 data suggest that this pattern is
continuing, with AI/AN having the highest opioid overdose death rate
among all race/ethnic groups. (Washington State Opioid Overdose
Prevention Data Brief: DOH 971-043 October 2020.)
SSPs are an essential component of preventing overdose deaths.
Tacoma Needle Exchange provides sterile syringes, which helps prevent
the spread of infectious diseases such as HIV, as well as services such
as opioid overdose prevention and awareness training, naloxone training
and distribution, wound care, and referrals for medication assisted
treatment and other medical and social services. Our outreach staff
meets people where they are and helps them address their needs in the
safest and healthiest way possible, free of judgement and stigma.
The following is but one example of what we do, and why we do it.
On Saturday, August 24, 2019, Tacoma Needle Exchange participated in an
event sponsored by the Pierce County Recovery Coalition. At this event
we conducted opioid overdose reversal trainings and distributed free
Narcan, a nasal version of naloxone (a drug which reverses an opioid
overdose), to any individual who requested it. Approximately 1 month
later, at another community event, I was approached by an individual
who had attended the August event. He told me that as he was driving
home the night of the 24th, just after the event, when he stopped for
gas. As he was filling his car, a panicked woman came out of the gas
station and stated that someone had overdosed in the restroom. He ran
to the restroom and using the training and naloxone we had given him
just 2 hours earlier, saved the life of that individual. He stated how
grateful he was to us for providing him with the tools to save a life.
SSPs are the most effective way to get naloxone into the hands of
people who use drugs and who are most likely to be at the scene of an
overdose. In 2019/2020, our team distributed approximately 18,000 doses
of naloxone and 1,259 overdose reversals were reported back to us (and
many more occurred that went unreported). People who use drugs are
essential partners in preventing overdose fatalities and are best
reached by SSPs. In fact, more than 99% of the reported overdose
reversals were performed by laypersons--other drug users, family
members, friends, bystanders--not by first responders. With additional
resources, SSPs can reach more people with naloxone, which would help
reduce the dramatically increasing number of overdose deaths.
Congress must respond to the overdose crisis, as well as work to
prevent and reduce infectious diseases related to drug use, such as HIV
and hepatitis C, by supporting and expanding access to SSPs. Infectious
diseases associated with opioid and other drug use have dramatically
increased across the U.S. Since 2010, the number of new hepatitis C
infections has increased by 380%. Outbreaks of viral hepatitis and HIV
among people who inject drugs continue to occur nationwide. The CDC has
documented over 30 years of studies that show that SSPs reduce overdose
deaths and infectious diseases transmission rates as well as increase
the number of individuals entering substance use disorder treatment.
These studies also confirm that SSPs do not increase illicit drug use
or crime and save money.
SSPs are among the only health care services trusted and used by
people who use drugs and so can effectively engage this highly
stigmatized population. SSPs help protect the community (including
first responders) by ensuring safe disposal of syringes, reducing rates
of infectious diseases, and can help providing a pathway to effective
mental health and substance use treatment and other medical care.
Unfortunately, the nation has insufficient access to SSPs and the
COVID-19 pandemic has decreased access to these life-saving services
when the need for services has increased dramatically. In January 2021,
Drug Policy Alliance conducted a survey of SSPs that showed that 91% of
respondents experienced an increase in clients in 2020, many as a
result of the COVID-19 pandemic. During this time of skyrocketing need,
42% of respondents experienced funding cuts in 2020 and expect such
shortfalls to continue in 2021. In response to funding shortfalls, many
SSPs have been forced to lay off staff and reduce services.
Consequently, because of decreased and limited resources, SSPs cannot
reach the millions of people who may benefit from their life-saving
services.
Federal funding would expand access to critical and effective SSP
programs. NASEN's own data show that there are only approximately 400
SSPs operating nationwide. Experts estimate that to sufficiently expand
access to SSP programs, the U.S. would require at least 2,000
programs--5 times the number in existence now. NASEN routinely provides
program support packages with essential harm reduction supplies to
organizations wishing to start SSPs. We consistently have a wait list
of 25-30 organizations seeking assistance, no matter how many support
packages we distribute.
A recent study that assessed the startup costs of an individual
program estimated that it would cost (in 2020 dollars) $490,000 for a
small rural program and $2.1 million for a large urban program,
resulting in an average start-up cost of $1.3 million per program.
Based on these numbers, the requested funding could provide modest
increases to currently operating SSPs to help address funding
shortfalls and help expand the number of SSPs nationwide.
Finally, expanding access to SSPs would reduce health care costs,
including for infectious diseases treatment. Hepatitis C treatment can
cost more than $30,000 per person, while HIV treatment can cost upwards
of $560,000 per person. Averting even a small number of cases would
save millions of dollars in treatment costs in a single year.
The Infectious Diseases and Opioid Epidemic Program at CDC helps to
eliminate infections related to injection drug-use and improve their
prevention, surveillance, and treatment. It also strengthens and
expands access to SSPs. In FY2019, CDC provided technical assistance to
help ensure high-quality, comprehensive services and best practices for
SSPs.
With additional FY22 funding, CDC could significantly expand SSPs
at this critical time to help prevent overdose deaths, the spread of
HIV and viral hepatitis, and connect people to life-saving medical
care. Unfortunately, with just months in office during a historic
COVID-19 pandemic and lacking a budget director, a director of the
Office of National Drug Control Policy, and other key officials needed
to respond to the overdose epidemic, the President's budget has only
increased funding by $6.5 million. This amount is inadequate to reverse
the dramatic increase in overdose deaths and to prevent continuing
outbreaks of HIV and hepatitis. Congress must respond now and
forcefully to this crisis or more lives will be lost to overdose and
countless people will continue to contract infectious diseases that
seriously compromise their personal health as well as the public
health, creating long-term costs for all.
Finally, on a personal note, I speak to you as a public health
researcher and SSP supporter and provider, but also--and more
importantly--as the older brother of someone who has struggled with
addiction his entire adult life and recently overdosed on fentanyl, but
thankfully survived. Over the years I have given him money and I have
paid his rent. I have purchased him clothes and bought him food. Yes,
there are days when I just did not have the emotional energy to pick up
the phone when I knew it was him calling. I admit this sadly and
shamefully. On those days, and particularly on those days, I am
thankful for the kind of people who work at syringe services programs.
They give without expectation of return and without judgement. They
give when others cannot or will not. It is with this experience and the
life of my brother in mind that I respectfully urge you to increase
funding for these life-saving programs.
Thank you for your time and consideration of my testimony, and
please do not hesitate to contact me or Jenny Collier at
[email protected] if you have questions or need additional
information.
[This statement was submitted by Paul LaKosky, Ph.D., Executive
Director, Dave Purchase Project, the North American Syringe Exchange
Network.]
______
Prepared Statement of the Deadliest Cancers Coalition
On behalf of the Deadliest Cancers Coalition, a collaboration of
national nonprofit organizations and industry focused on addressing
issues related to our nation's most lethal cancers, we submit this
statement in support of strengthening the federal investment in
deadliest cancers research conducted and supported by the National
Institutes of Health (NIH) and the National Cancer Institute (NCI). For
Fiscal Year 2022, we respectfully request $46.111 billion for the NIH's
base program budget level, including $7.9 billion for the NCI, as well
as the funding needed to establish a new Advanced Research Projects
Agency for Health (ARPA-H) that includes a focus on finding tools to
help patients diagnosed with one of the deadliest cancers. We further
request report language in the LHHS bill that continues to hold NCI
accountable for making progress on the goals and ideals of the
Recalcitrant Cancer Research Act (RCRA).
In his address to Congress, President Biden called for an ``end to
cancer as we know it''. As the national coalition that represents the
cancers for which we've seen the least amount of progress, we
wholeheartedly endorse this statement. We deeply appreciate Congress'
continued strong leadership in support of cancer research through the
steady increases you have provided to the NIH and NCI over the last six
years. Funding for the existing components of the NIH and NCI is a
critical component of making the goal of ``ending cancer'' a reality,
which is why we have joined with our partners in the One Voice Against
Cancer Coalition to support the funding requests for NIH and NCI listed
above.
We also support President Biden's call for a new ARPA-H that has an
initial focus on cancer and other diseases for the purpose of driving
transformational innovation in health research and speeding application
and implementation of health breakthroughs. As representatives of
patients who have been diagnosed with our nation's most lethal cancers
and those who currently have the fewest early detection and treatment
options available, we believe that ARPA-H has the potential to provide
a vital bridge between this dearth of effective tools and the improved
survival rates that are so desperately needed.
The discussion between physicians and patients diagnosed with a
deadliest cancer are currently focused on end-of-life instead of
exploring treatment options that will provide the best quality of life
and the extension of life. These cancers exemplify areas where medical
practice would be dramatically changed through the technologies and
platforms that could be developed under ARPA-H. For these reasons, we
urge Congress and the Administration to ensure that ARPA-H focuses on
the hardest problems and areas where medical practice will be
dramatically changed, including the deadliest cancers, as it develops
authorizing language.
We know that this Subcommittee will face many difficult decisions
as it is developing the FY 2022 Appropriations Bills. As you are
considering these bills, we further encourage you to structure ARPA-H
so that no funding is diverted from the core mission and budgets of the
NIH and NCI, but also allows for true innovation.
It is also essential that critical stakeholders in the cancer
community be involved at the earliest outset in the design, structure
and budget of these endeavors. ``Cancer'' is not one disease, so it is
therefore vital that stakeholders representing the range of the
``cancer experience'' be involved in these efforts. For this reason,
the Deadliest Cancers Coalition respectfully requests to be involved in
the process, starting in the initial phase.
The deadliest cancers offer a powerful example of the need for
continuing the path of sustained and robust increases for the NIH and
NCI. While the overall five-year relative survival rate for all cancers
combined has risen from 50 percent when the War on Cancer was first
declared in 1971 to 67 percent today, we have seen relatively little
success in improving survival for the deadliest cancers. Multiple
myeloma is one of the few ``success'' stories among this group as the
five-year survival rate was 34 percent when the coalition was founded
in 2008 and is now 54 percent.
Next year (2022) will mark the 10-year anniversary of the passage
of the RCRA, which requires that the NCI develop long-term strategic
plans for addressing recalcitrant cancers beginning with pancreatic
adenocarcinoma and small-cell lung cancer. The NCI has made progress in
implementing the statute, particularly with respect to pancreatic
adenocarcinoma and small-cell lung cancer. As a result of report
language in the FY 2020 and FY 2021 LHHS Appropriations bills, NCI will
undertake a scientific framework process for glioblastomas and
gastroesophageal cancers and recently issued a notice of intent to
publish a funding opportunity announcement for a Program on the Origins
of Gastroesophageal Cancers. It is therefore crucial that Congress
continue to shine a light on all recalcitrant cancers so they do not
slip back into the shadows and so progress on implementing the RCRA for
all of the deadliest cancers continues.
The Deadliest Cancers Coalition deeply appreciates the inclusion of
report language focusing on these cancers in years past, including the
FY 2021 language that reiterated Congress' intention that NCI develop a
scientific framework using the process outlined in the RCRA for stomach
and esophageal cancers and directed the NCI to identify future goals
for each of the deadliest cancers in the fiscal year 2022 CJ.
We are seeking language in the FY 2022 LHHS Appropriations bills
that continues to hold NCI accountable to the FY20 and FY21 language
and the goals and ideals of the RCRA. Given that NCI has been
responsive, to some degree, when Congress directs them to focus on
specific cancers, we ask the language identify liver cancer as the next
focus area. We are asking that the language specifies that the process
should include cholangiocarcinoma, which is cancer that originates in
the bile duct, but is grouped together with liver cancer, but want NCI
to have flexibility on which other liver cancer subtype(s) should be
included.
In addition, we continue to believe that it is critical that NCI
stipulates how it will continue the goals of the RCRA to develop and
implement strategic plans for the full range of recalcitrant cancers.
The 2012 legislation was first introduced by Representatives Anna Eshoo
and Leonard Lance and Senator Whitehouse and gained significant bi-
partisan support because it was clear that just following ``standard
procedure'' with respect to recalcitrant cancers was not working and
there needed to be a specific focus on determining research priorities
for these diseases. That need has not diminished.
The Deadliest Cancers Coalition was founded because we believe in a
future in which there is no form of cancer for which a diagnosis is an
automatic death sentence. All cancer patients should be able to select
the best treatment option for them in consultation with their physician
from a variety of effective treatments. Unfortunately, this year,
approximately 44 percent of all cancer-related deaths will be due to
one of the deadliest cancers, which means that we clearly have a long
road ahead of us before that future is more than a dream. We therefore
urge the Subcommittee to continue its leadership to ensure that NIH
receives $46.111 billion for the NIH's base program budget level for FY
2022, including $7.9 billion for the NCI, as well as the funding needed
to establish a new ARPA-H that includes a focus on the deadliest
cancers. We further urge you to continue to hold the Institute
accountable to making progress on the deadliest cancers through report
language in the FY 2022 bill.
______
Prepared Statement of the Department of Preventive Medicine and
Department of Medicine, Infectious Diseases
Dear Committee Members,
I am writing in support of a FY 2022 budget request for Department
of Health and Human Services to develop a national strategy and
implementation plan for the prevention, control and treatment of Herpes
Simplex Virus, Types 1 and 2.
It is a critical public health imperative to address Herpes Simplex
Virus (HSV), a chronic viral infection that impacts nearly half of
Black women in our country, disproportionately impacts LGBTQ
populations, and is a widely recognized driver of the HIV epidemic.
Approximately 40% of new cases of HIV infection are attributable to
chronic HSV infection. HSV also kills approximately 1,000 infants
annually as a result of neonatal herpes which is currently not a
reportable condition. Additionally, there is a growing body of research
indicating HSV as a contributing factor to Alzheimer's Disease,
Encephalitis, Bell's Palsy, among other neurodegenerative diseases.
There is currently no centralized national strategy to address HSV,
it is not tracked or routinely tested for, and the majority of spread
is via asymptomatic carriers unaware of their status. We can and should
be doing more to stop the spread and provide better treatment to the
nearly 1 in 3 Americans with this chronic condition.
If we prioritize women's and maternal health, the health of Black,
Hispanic, LGBTQ, indigenous and other at-risk communities, we must
prioritize Herpes Simplex Virus treatment and prevention. If we
prioritize mental health, biomedical research for incurable diseases
such as Alzheimer's or HIV, and dismantling systemic racism in
healthcare, we must also prioritize Herpes Simplex Virus control.
Addressing HSV addresses all of these national priorities and can
improve the health, quality of life, and reduce the economic burden for
millions of Americans.
Sincerely.
[This statement was submitted by Jeffrey D. Klausner, MD MPH,
Clinical
Professor, Department of Preventive Medicine and Department of
Medicine,
Infectious Diseases.]
______
Prepared Statement of Duke Health
Duke Health (the conceptual integration of the Duke University
Health System, the schools of Medicine and Nursing, the Private
Diagnostic Clinic as the independent, multi-specialty physician
practice, and other health and health research centers across Duke
University) would like to express appreciation for federal support
provided to academic health centers across the United States,
especially during the COVID-19 public health emergency. COVID-19 has
illustrated how vital the investments from this Subcommittee are for
strengthening a health care infrastructure in the United States that
can research and develop new vaccines and therapeutics and provide
high-quality care to patients at all times.
Duke Health is committed to conducting innovative basic and
clinical research, rapidly translating breakthrough discoveries to
patient care and population health, providing a unique educational
experience to future clinical and scientific leaders, improving the
health of populations, and actively seeking policy and intervention-
based solutions to complex global health challenges. Underlying these
ambitions is a belief that Duke Health is a destination for outstanding
people and a dedication to continually explore new ways to help people
grow, collaborate, and succeed.
Reflecting Duke Health's mission of ``Advancing Health Together,''
this written testimony outlines Duke Health's biomedical research and
health care priorities that represent sound investments in vital
programs at HHS that make a difference in the lives of patients across
the United States. Thank you for this opportunity to submit written
testimony.
national institutes of health (nih)
Duke Health is grateful for Congress' robust investments in NIH,
which has kept the United States on the cutting edge of new biomedical
advances. For FY 2022, Duke Health respectfully requests at least $46.1
billion for the NIH. This represents a $3.177 billion increase over the
comparable FY 2021 funding level for the NIH, which would allow for the
NIH's base budget to keep pace with the biomedical research and
development price index (BRDPI) and allow meaningful growth of 5%.
At Duke, NIH funding plays a critical role in the advancement of
research and clinical care. NIH has supported research at the Duke
Clinical Research Institute, the world's largest academic research
organization working to improve patient care through innovative
clinical research; the Duke Human Vaccine Institute, a national and
international leader in the fight against major infectious diseases and
home to one of 12 Regional Biocontainment Labs; and the Duke Cancer
Institute, a top comprehensive cancer center in peer-reviewed research
support.
We are grateful for the emergency investments made by Congress over
the past year to meet historical challenges, and it is critical that we
continue to build upon the current foundation to sustain and grow our
nation's research enterprise.
We also are deeply grateful for the $40 million appropriated to the
National Institute of Allergy and Infectious Disease for Regional
Biocontainment Laboratories (RBLs) in the Consolidated Appropriations
Act, 2021. This investment bolstered the nation's preparedness for
biodefense and emerging infectious disease agents, including COVID-19,
as RBLs continue to provide some of the major advancements in
understanding and combating the coronavirus through the development of
vaccines, prophylactic and therapeutic treatments, and diagnostic tests
for SARS-CoV-2 and COVID-19 disease. We respectfully request that RBLs
be considered for an annual appropriation of $60 million to be shared
evenly among the 12 RBL research institutions beginning in FY 2022. The
assays for live virus neutralization for all the monoclonal antibodies
at Duke are done in the Duke RBL and it is where all live virus
cultures are done for CoV2 work. Additionally, Duke researchers have
created a vaccine with the potential to protect against all forms of
coronavirus that move from animals to humans, now and in the future.
The new vaccine has been 100 percent effective in non-human tests.
Finally, Duke Health asks the Subcommittee to not include language
that would limit the use of nonhuman primates in research that could
cripple the search for treatments and cures for many human diseases,
especially therapeutics and vaccines for COVID-19.
centers for disease control and prevention (cdc)
The CDC serves as the command center for the nation's public health
defense system against emerging and reemerging infectious diseases.
Now, more than ever, investments in the nation's public health
infrastructure and public health defense systems are critical. Duke
Health urges the Subcommittee to provide at least $10 billion for the
CDC in FY 2022. Among the CDC's many programs, the Prevention
Epicenters Program connects CDC's Division of Healthcare Quality
Promotion with academic investigators to conduct innovative infection
control and prevention research. The Duke-UNC Epicenter has
considerable experience and research expertise in hospital
epidemiology, infection control, antimicrobial stewardship,
epidemiologic studies of multidrug-resistant organisms, disinfection,
and sterilization. In addition, the Duke Infection Control Outreach
Network (DICON) and Duke Antimicrobial Stewardship Outreach Network
(DASON) engage over 60 community hospitals in the United States.
health resources and services administration (hrsa)
Duke Health appreciates the Subcommittee's continued investment in
Title VII health professions and training programs and Title VIII
Nursing Workforce Development programs at HRSA. These programs ensure a
well-trained pipeline of health professionals to meet the increasing
health needs facing the United States. For FY 2022, Duke Health
respectfully requests that the Subcommittee provide $1.51 billion for
Title VII and VIII programs overall, including $980 million to Title
VII programs and $530 million to Title VIII programs. Title VII and
Title VIII are the only federal programs that support education/
training opportunities for an array of aspiring and practicing health
professionals, both facilitating career opportunities and bringing
health care services to rural and underserved communities.
Duke Health urges the Subcommittee to provide $23 million in FY
2022 for the National Cord Blood Inventory (NCBI) at HRSA. This program
is charged with building a genetically and ethnically diverse inventory
of at least 150,000 new units of high-quality umbilical cord blood for
transplantation. These cord blood units, as well as other units in the
inventories of participating cord blood banks, are made available to
physicians and patients for blood stem cell transplants through the
C.W. Bill Young Cell Transplantation Program. Cord blood banks
participating in the NCBI Program, including the Carolinas Cord Blood
Bank in the Duke University School of Medicine, also make cord blood
units available for preclinical and clinical research focusing on cord
blood stem cell biology and the use of cord blood stem cells for human
transplantation and cellular therapies.
Blood stem cell transplantation is potentially a curative therapy
for many individuals with leukemia and other life-threatening blood and
genetic disorders. Each year, nearly 18,000 people in the U.S. are
diagnosed with illnesses for which blood stem cell transplantation from
a matched donor is their best treatment option. Often, the first-choice
donor is a sibling, but only 30 percent of people have a fully tissue-
matched brother or sister. For the other 70 percent, a search for a
matched unrelated adult donor or a matched umbilical cord blood unit
must be performed. The success of cord blood stem cell therapies in
treating diseases and alleviating suffering makes an urgent and
compelling case for funding this program.
Duke Health respectfully requests the Subcommittee provide $31
million for the C.W. Bill Young Cell Transplantation Program through
the NCBI at HRSA in FY 2022. The Carolinas Cord Blood Bank (CCCB) at
Duke is a member bank of the NCBI of the C.W. Bill Young Cell
Transplantation Program. The goal of this program is to increase the
number of transplants for recipients suitably matched to biologically
unrelated donors of bone marrow and umbilical cord blood. The CCBB is
one of the largest cord blood banks in the world. Cord blood units that
are banked at CCBB are listed on the National Marrow Donor Program
(NMDP) Be the Match(r) Registry, an accumulated listing of donated cord
blood units from participating banks that are available to provide
donors for patients needing a hematopoietic stem cell transplant to
treat cancer or certain genetic diseases.
Thousands of mothers have donated their cord blood to the CCBB.
Banked units are comprised of African-American, Hispanic-American,
Asian-American, and Caucasian samples. This diversity helps patients of
all racial and ethnic backgrounds find suitable matches for
transplantation. The CCBB has distributed cord blood units for
transplantation to several thousand patients since 1999. Cord blood
recipients of CCBB units include children and adult patients facing
life-threatening illnesses who need a ``stem cell'' transplant from an
unrelated donor to provide them with healthy blood cells. Many of these
patients have been affected by leukemia, lymphoma, severe aplastic
anemia, or other fatal diseases of the blood or immune system, or
certain inherited metabolic diseases. In addition to life-saving
transplants, the CCBB also provides cord blood units for research.
These units are made available to investigators for critical research
in the area of cord blood and stem cell biology. The impact of funding
has far reaching impacts, and Duke Health urges the Subcommittee to
support this request.
agency for healthcare research and quality (ahrq)
Duke Health urges the Subcommittee to provide $500 million for the
Agency for Healthcare Research and Quality in FY 2022. This funding
level is consistent with the FY 2010 level adjusted for inflation and
would allow AHRQ to rebuild portfolios terminated as a result of years
of past cuts and expand its research and training portfolio to address
our nation's pressing and evolving health care challenges. As the
agency that provides funding for health systems research, AHRQ is vital
to improving health, safety, and health outcomes for patients. AHRQ is
forward thinking, addressing issues such as data analytics, and is
providing important resources for healthcare professionals during
COVID-19.
Patients with sickle cell disease (SCD), an inherited red blood
cell disorder, often have intense pain that brings them to hospital
emergency departments (EDs) for immediate treatment. Their care can be
fragmented, with frequent hospitalizations and specialist care,
infrequent follow-up with primary care doctors, and repeat ED visits.
Funding from AHRQ supports activities at the Duke University School of
Nursing to improve the care of these patients in the ED department,
particularly through the development and use of evidence-based decision
support tools. In addition, 80 to 90 percent of medical center leaders
at the Private Diagnostic Clinic (PDC), a multispecialty physician
practice affiliated with Duke Health, reported fewer communications
breakdowns and better handling of disagreements after using AHRQ's
TeamSTEPPS(r) team training curriculum.
substance abuse and mental health services administration (samhsa)
Duke Health appreciates investments in the National Child Traumatic
Stress Network (NCTSN) grant program at SAMHSA, especially efforts to
provide additional funding for this program during COVID-19. For FY
2022, Duke Health urges the Subcommittee to provide $81.9 million for
NCTSN.
NCTSN, which is coordinated by the UCLA-Duke University National
Center for Child Traumatic Stress, increases access to services for
children and families who experience or witness traumatic events. This
unique network of frontline providers, family members, researchers, and
national partners is committed to changing the course of children's
lives by improving their care and moving scientific gains quickly into
practice across the U.S. In recent years, estimates from the NCTSN
Collaborative Change Project (CoCap) have indicated that each quarter
about 35,000 individuals--children, adolescents, and their families--
directly benefited from services through this Network. Since its
inception, the NCTSN has trained more than one million professionals in
trauma-informed interventions. Hundreds of thousands more are
benefiting from the other community services, website resources,
educational products, community programs, and more. Over 10,000 local
and state partnerships have been established by NCTSN members in their
work to integrate trauma-informed services into all child-serving
systems, including child protective services, health and mental health
programs, child welfare, education, residential care, juvenile justice,
courts, and programs serving military and veteran families.
office of the assistant secretary for preparedness and response (aspr)
Duke Health requests that the Subcommittee provide $11.5 million,
full authorized funding, for the Military and Civilian Partnership for
the Trauma Readiness Grant Program for FY 2022 within ASPR. Originally
known as MISSION ZERO, this critical program would provide funding to
ensure trauma care readiness by integrating military trauma care
providers into civilian trauma centers. These partnerships allow
military trauma care providers to gain exposure to treating critically
injured patients in communities and keep their skills sharp to increase
readiness for deployment. Additionally, they allow civilian trauma care
providers to gain insight into best practices from the battlefield that
can be integrated into civilian care. Fully funding this program will
help to improve the nation's response to public health and medical
emergencies.
______
Prepared Statement of the Dystonia Medical Research Foundation
summary of recommendations for fiscal year 2022
_______________________________________________________________________
--Provide $46.1 billion for the National Institutes of Health (NIH)
and proportional increases across its Institutes and Centers.
--Continue dystonia research supported by NIH through the National
Institute on Neurological Disorders and Stroke (NINDS), the
National Institute on Deafness and other Communication
Disorders (NIDCD), and the National Eye Institute (NEI).
--Provide the Centers for Disease Control and Prevention (CDC) with
at least $10 billion to facilitate timely public health
efforts.
--Please provide $5 million for the new Chronic Disease Education and
Awareness Program at CDC.
_______________________________________________________________________
Dystonia is a neurological movement disorder that causes muscles to
contract and spasm involuntarily. It affects men, women and children.
Dystonia can be generalized, affecting all major muscle groups, and
resulting in twisting, repetitive movements and abnormal postures or
focal, affecting a specific part of the body such as legs, arms, hands,
neck, face, mouth, eyelids and vocal cords. Currently, it is estimated
that at least 300,000 individuals in North America suffer from
dystonia, making it more common than Huntington's, muscular dystrophy,
and ALS. There is no known cure for dystonia.
In 1967 at the age of 10, I lost the ability to write with either
hand. Five years later, my father (at the age of 53) and I were
diagnosed with focal dystonia, affecting our hands, which spasm and
twist when we attempt to write. My sister, her son, and my daughter
were later given the same diagnosis. Unlike the others, with every
passing year, my daughter's dystonia began to affect other regions. By
19, she was unable to walk or feed herself. Later that year, she
underwent deep brain stimulation (DBS) surgery which changed her life.
She was later able to return to and graduate from college and now lives
a relatively normal and active life.
I realized at the time of my daughter's diagnosis that I needed to
do more. I became a clinical trial participant at the NIH and
volunteered for any studies that could help researchers in finding a
cure and or better treatments. I also became a passionate advocate for
dystonia research funding.
dystonia research at the national institutes of health (nih)
The Dystonia Medical Research Foundation urges the Subcommittee to
continue its support for natural history studies on dystonia that will
advance the pace of clinical and translational research to find better
treatments and a cure. In addition, we encourage Congress to continue
supporting NINDS, NIDCD, and NEI in conducting and expanding critical
research on dystonia.
Currently, dystonia research at NIH is supported by the National
Institute of Neurological Disorders and Stroke (NINDS), the National
Institute on Deafness and Other Communication Disorders (NIDCD), and
the National Eye Institute (NEI).
The majority of dystonia research at NIH is supported by NINDS.
NINDS has utilized a number of funding mechanisms in recent years to
study the causes and mechanisms of dystonia. These grants cover a wide
range of research including the genetics and genomics of dystonia, the
development of animal models of primary and secondary dystonia,
molecular and cellular studies in inherited forms of dystonia,
epidemiology studies, and brain imaging. We continue to work with the
leadership of NINDS on the recommendations stemming from our 2018
meeting that focused on defining emerging opportunities in dystonia
research.
Key findings include 1) noting that the heterogeneity of dystonia
poses challenges to research and therapy development. 2) There is more
to be learned from genetic subtypes, along clinical, etiology, and
pathophysiology axes. 3) In order to facilitate key advancements in
research technology, there needs to be more research collaboration. 4)
New research priorities should include the generation and integration
of high-quality phenotypic and genotypic data. 5) Reproducing key
features in cellular and animal models, both of basic cellular
mechanisms and phenotypes, leveraging new research technologies. 6)
Collaboration is necessary both for collection of large data sets and
integration of different research methods.
It is of great significance that a number of dystonia patient
advocacy group, led by the Dystonia Medical Research Foundation,
actively took part in the meeting and are working to ensure that
Congress continues to support robust NIH funding.
NIDCD and NEI also support research on dystonia. NIDCD has funded
many studies on brainstem systems and their role in spasmodic
dysphonia, or laryngeal dystonia. Spasmodic dysphonia is a form of
focal dystonia which involves involuntary spasms of the vocal cords
causing interruptions of speech and affecting voice quality. NEI
focuses some of its resources on the study of blepharospasm.
Blepharospasm is an abnormal, involuntary blinking of the eyelids which
can render a patient legally blind due to a patient's inability to open
their eyelids. We were pleased to see that Congress has encouraged both
NIDCD and NEI to expand their research into both spasmodic dysphonia
and blepharospasm.
We thank the committee for the increase for NIH in fiscal year
2021. We know firsthand that this will further NIH's ability to fund
meaningful research that benefits our patients.
cdc's chronic disease education and awareness program
We strongly support and thank the Subcommittee for the creation of
the new Chronic Disease Education and Awareness Program at CDC. This
critical program would provide a dedicated pool of resources that could
be deployed to support meritorious public health projects with
stakeholders. This program seeks to provide collaborative opportunities
for chronic disease communities that lack dedicated funding from
ongoing CDC activities. Such a mechanism allows public health experts
at the CDC to review project proposals on an annual basis and direct
resources to high impact efforts in a flexible fashion.
patient perspectives
Blepharospasm
I drive through Atlanta's brutal traffic when suddenly, my eyes
clamp shut. I pry my left eye open with thumb and forefinger, steer
with my right hand. My eyes open for a few seconds, then close with no
warning. What is happening? Over the next few months, these spasms
progress from eyes to lower face, neck and shoulders. A year later I am
diagnosed with Dystonia, a debilitating, little-known disease. A
healthy 49-year-old mother of three, I now fight constant pain; can no
longer work, drive or perform basic activities. Even walking our dog is
a dangerous fall risk.
Spasmodic dysphonia
Spasmodic dysphonia (SD), a focal form of dystonia, is a
neurological voice disorder that involves ``spasms'' of the vocal cords
causing interruptions of speech and affecting voice quality. My voice
sounds strained or strangled with breaks where no sound is produced.
When untreated, it is difficult for others to understand me. I receive
injections of botulinum toxin into my vocal cords every three months
for temporary relief of symptoms. This has worked well for me for over
a decade. At the start of this year, my insurance coverage changed when
my husband's company changed providers. As a result, I had to undergo
an extensive review process and change methods for obtaining my
medicine. The review lasted for four weeks. Multiple times during this
time period, my doctor and I were told that I had been denied coverage.
We had to make numerous phone calls to encourage the company and
specialty pharmacy to review my case again and again. These phone calls
were extremely difficult as my voice deteriorated from the delay in
treatment. The automated phone systems were the worst, but the
representatives also had trouble understanding my broken voice and I
had to repeat my information over and over. Finally, the company
determined my treatment is medically necessary and has approved it for
one year. After a seven week delay, I am scheduled for my injection and
am looking forward to a period of spasm-free speaking.
We are grateful to those persons who share their stories with the
DMRF and other dystonia patient groups to help raise awareness of
dystonia. The DMRF was founded in 1976 and since its inception, the
goals have remained to advance research for more effective treatments
of dystonia and ultimately find a cure; to promote awareness and
education; and support the needs and wellbeing of affected individuals
and their families.
Thank you for the opportunity to present the views of the dystonia
community, we look forward to providing any additional information.
[This statement was submitted by Carole Rawson, Vice President of
Public Policy, Dystonia Medical Research Foundation.]
______
Prepared Statement of Education Finance Council
Chairwoman Murray, Ranking Member Blunt, and members of the
Subcommittee on Labor, Health and Human Services, Education and Related
Agencies, Education Finance Council (EFC) is submitting this testimony
because we have great concerns over the fast-approaching expiration of
the COVID-19 payment pause on federally-owned student loans and the
lack of certainty and guidance surrounding the September 30, 2021 date.
There is speculation about an extension of that pause, and we must be
cognizant of the herculean task of assisting more than 40 million
borrowers in transitioning back into repayment. We request that you
seek such certainty from the U.S. Department of Education (Department)/
Federal Student Aid (FSA) and require them to provide servicers of
federally-owned student loans, borrowers, and other stakeholders with
the date when the COVID-19 payment pause for federally-owned loans will
end.
This date certain must come as soon as possible as federal student
loan servicers need appropriate time to hire and train staff and begin
communication to borrowers in order to be fully prepared to
successfully transition borrowers into repayment. The pause, which
began in March 2020, is currently scheduled to end on September 30,
2021, and servicers are currently prohibited from communicating with
affected borrowers regarding entering repayment.
It is imperative that FSA communicate clearly and consistently, as
early as possible, with federal student loan servicers, borrowers, and
all stakeholders about when the COVID-19 payment pause on federally-
owned student loans will end. Borrowers need to have certainty about
when their loans will enter repayment, and communication about this
needs to begin as soon as possible with unified messaging. It all
begins with the Department/FSA providing servicers, borrowers, and
other stakeholders certainty of the end of the payment pause date so
that the information borrowers receive from servicers and other sources
is consistent.
This document describes what EFC members that service federally-
owned student loans must do to help borrowers prepare for the start of
repayment, ensure a smooth transition, and remain in compliance with
FSA requirements--a process that takes several months.
communication with borrowers
There are approximately 40 million borrowers that will enter
repayment when the COVID-19 payment pause for federally-owned student
loans ends. Outreach to these borrowers must begin many months before
repayment begins, particularly to those who are at a high risk for
falling into delinquency when payments resume,\1\ and to borrowers who
completed undergraduate study during the payment pause and have never
had to make student loan payments. However, servicers have been
instructed to temporarily cease communication with borrowers until
notified differently by the Department. It is critical that servicers
are allowed to begin this outreach as soon as possible to provide the
borrowers the information they need to prepare to enter repayment on
their student loans, especially certainty of the date that repayment
will begin.
---------------------------------------------------------------------------
\1\ The Department of Education's Congressional Budget
Justification for Student Aid Administration for Fiscal Year 2022
acknowledges this risk for certain groups of borrowers:
``...approximately 3.9 million borrowers shifted out of delinquency
status through the government-provided-forbearance. The Department
acknowledges that these borrowers are at high risk of re-entering
delinquency, and eventually defaulting, once the payment pause ends. In
addition, many borrowers who completed undergraduate study during the
payment pause have never had to make student loan payments at all,
which could also present special challenges. Further, some Americans
have experienced unemployment or decreased earnings during the
pandemic, and as a result, some borrowers who were current on their
payments prior to the pause may be at higher risk of delinquency.''
(Department of Education, Congressional Budget Justification for
Student Aid Administration for Fiscal Year 2022, AA-28).
---------------------------------------------------------------------------
Informing borrowers that they will be entering repayment, when it
will occur, and what will be required of them as early as possible and
via as many channels as possible will prevent unnecessary delinquencies
and default. Borrowers need time to budget and update their accounts.
For example, borrowers using direct debits need to know as soon as
possible if the direct debit will be automatically reapplied and the
amount and date of when the first debit will occur. If it is not
automatically reapplied, the borrower needs to know when and how to
reestablish that process long before payment becomes due.
Furthermore, the pandemic has disrupted the living situation of
many borrowers, making early outreach more important than ever. Many
borrowers have experienced changes in their living situations. Some may
have moved home with parents or relocated due to employment changes or
for other reasons but may not have updated their contact information
with servicers. It takes time to find those borrowers and ensure they
receive the proper notifications. Servicers must comply with
regulations that dictate how early different types of notices regarding
repayment and repayments plans must be sent to borrowers, which is an
impossibility until they are permitted to resume borrower
communications.
staffing and it needs
Many servicers experienced a reduction in staff during the COVID-19
pandemic and payment pause period due to attrition and the need for
fewer employees. Servicers need to begin hiring and training additional
staff as soon as possible to ensure that borrowers experience a smooth
transition back into repayment. However, uncertainty about whether the
payment pause will end on September 30, 2021, as scheduled is delaying
this process.
It takes time to locate, hire, train and prepare individuals to
service federal student loans. This process includes advertising and
interviewing appropriate candidates, completing federally required
background checks, completing application for and receiving FSA
security clearance (a process that can take weeks to months), and
training of new employees. Federal student loan programs and repayment
options and rules are very complex and servicing federal student loans
requires specialized training that can span 4 to 8 weeks, depending on
the servicer's training process and the employees' position with the
organization. In most cases, training will need to begin by mid-July to
be completed in time. Ongoing training occurs with personnel even after
they are released to communicate with borrowers to ensure they remain
current with any regulatory or statutory changes that may impact a
borrower.
There are also system changes that need to be implemented to get
millions of accounts back into repayment. This will require IT staff
time, and servicers need to know as soon as possible when this process
can begin.
We appreciate your consideration of this request for timely
communication to all parties in order to ensure we are collectively
prepared to best communicate and assist federal student loan borrowers
as they transition back to active repayment.
About Education Finance Council (EFC): EFC is the national trade
association representing nonprofit and state-based higher education
finance organizations that, as mission-driven, public purpose
organizations, are dedicated to improving college access, success, and
affordability in their states and nationwide. EFC members operate as
loan servicers and supplemental loan originators and provide a wide
array of college access and student success and support services and
resources.
[This statement was submitted by Gail daMota, President, Education
Finance Council.]
______
Prepared Statement of the Endocrine Society
The Endocrine Society thanks the Subcommittee for the opportunity
to submit the following testimony regarding Fiscal Year (FY) 2022
federal appropriations for biomedical research and public health
programs. The Endocrine Society is the world's oldest and largest
professional organization of endocrinologists representing
approximately 18,000 members worldwide. The Society's membership
includes basic and clinical scientists who receive support from the
National Institutes of Health (NIH) for research on endocrine diseases
that affect millions of Americans, such as diabetes, thyroid disorders,
cancer, infertility, aging, obesity and bone disease. Our membership
also includes clinicians who depend on new scientific advances to
better treat and cure these diseases. The Society is dedicated to
promoting excellence in research, education, and clinical practice in
the field of endocrinology. The impact of the coronavirus is a
compelling illustration of why we must increase funding for the NIH and
CDC to protect public health. To support necessary advances in
biomedical research to improve health, the Endocrine Society recommends
the NIH receive funding of at least $46.1 billion for fiscal year (FY)
2021; to facilitate the translation of these advances to improve public
health, the Endocrine Society recommends the Centers for Disease
Control and Prevention (CDC) receive funding of at least $10 billion;
and to ensure that women have access to appropriate health services, we
recommend that the Title X program be funded at $737 million. This
request does not reflect emergency supplemental funds or new programs
situated in NIH including the Advanced Research Projects Agency for
Health proposed by the administration.
endocrine research improves public health
Sustained investment by the United States federal government in
biomedical research has dramatically advanced the health and improved
the lives of the American people. The United States' NIH-supported
scientists represent the vanguard of researchers making fundamental
biological discoveries and developing applied therapies that advance
our understanding of, and ability to treat human diseases. Their
research has led to new medical treatments, saved innumerable lives,
reduced human suffering, and launched entire new industries.
Endocrine scientists are a vital component of our nation's
biomedical research enterprise and are integral to the healthcare
infrastructure in the United States. Endocrine Society members study
how hormones contribute to the overall function of the body and how the
glands and organs of the endocrine system work together to keep us
healthy. Physiological functions governed by the endocrine system are
essential to overall wellbeing: endocrine functions include
reproduction, the body's response to stress and injury, sexual
development, energy balance and metabolism, and bone and muscle
strength. Endocrinologists also study interrelated systems, for example
how hormones produced by fat influence the development of cancer or
susceptibility to infections.
endocrine research is supported by numerous nih institutes
Endocrine diseases and disorders are studied by researchers funded
by multiple NIH Institutes and Centers (ICs). As such, it is critical
for NIH to receive a strong base appropriation with proportional
increases for all ICs. For example:
--Diabetologists funded by the National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK) are advancing knowledge
of inequities contribute to health disparities in outcomes
associated with COVID-19.\1\ Despite the critical importance of
this issue, NIDDK received a much lower increase in funding in
FY 2021, relative to other ICs.
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\1\ Ebekozien, O., et al., The Journal of Clinical Endocrinology &
Metabolism, Volume 106, Issue 4, April 2021, Pages e1755-e1762, https:/
/doi.org/10.1210/clinem/dgaa920.
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--Endocrine researchers funded by the National Institute of Aging
increased our understanding of how hormonal treatment for
menopause might improve stress responses in women.\2\
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\2\ https://www.endocrine.org/news-room/press-release-archives/
2017/treating-menopausal-symptoms-can-protect-against-stress-negative-
effects Accessed March 11, 2018.
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--Researchers funded by the Eunice Kennedy Shriver National Institute
of Child Health and Human Development (NICHD) are discovering
how hormones influence the gut microbiome, which in turn can
influence the development of polycystic ovarian syndrome
(PCOS).\3\
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\3\ Torres, PJ, et al., The Journal of Clinical Endocrinology &
Metabolism, jc.2017-02153.
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--Endocrine oncologists supported by the National Cancer Institute
(NCI) discovered how certain drugs used during pregnancy can
contribute to cancer risk in offspring.\4\
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\4\ https://www.endocrine.org/news-and-advocacy/news-room/featured-
science-from-endo-2021/drug-used-during-pregnancy-may-increase-cancer-
risk-in-mothers-adult-children.
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--National Institute of Environmental Health Science (NIEHS)-funded
researchers are investigating how chemicals found in cosmetic
products can disrupt endocrine systems resulting in increased
cancer risk.\5\
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\5\ https://endocrinenews.endocrine.org/edc-exposure-during-
pregnancy-may-reduce-breast-cancer-protection/.
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nih requires steady, sustainable funding increases
The Endocrine Society appreciates increases to the NIH budget in
recent fiscal years; however, the biomedical research community
requires steady, sustainable increases across the biomedical research
enterprise in funding to ensure that the promise of scientific
discovery can efficiently be translated into new cures. Research
budgets have been further stretched across NIH to drive research to
help us address the COVID-19 pandemic, and emergency supplemental funds
have not provided sufficient resources to advance necessary research on
COVID-19 while also sustaining progress on other national priorities.
Consequently, NIH grant success rates are predicted to remain close to
historically low averages, meaning highly skilled scientists will
continue to spend more time writing highly meritorious grants that will
not be funded. Young scientists will also continue to be driven out of
biomedical research careers due to the lack of funding.
adequate funding of cdc programs is necessary to protect the public's
health
The CDC plays a critical role in protecting the public's health by
applying new knowledge to the promotion of health and prevention of
chronic diseases, including diabetes. The Division of Diabetes
Translation administers the National Diabetes Prevention Program
(National DPP), which addresses the increasing burden of prediabetes
and Type 2 Diabetes in the United States. The National DPP creates
public and private partnerships to provide evidence-based, cost-
effective interventions that prevent diabetes in community-based
settings. Through structured lifestyle change programs at local YMCAs
or other community centers, individuals with prediabetes can reduce the
risk of developing diabetes by 58% in those under 60 and by 71% in
those 60 and older.\6\ In addition to supporting public health and
prevention activities, CDC's Clinical Standardization Programs in the
Center for Environmental Health are critical to improving accurate and
reliable testing of hormones, appropriate diagnosis and treatment of
disease, and reproduceable public health research. Adequate funding is
critically important to ensure that CDC has the capacity to address
existing and emerging threats to public health in the United States and
around the world.
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\6\ The Diabetes Prevention Program (DPP) Research Group Diabetes
Care. 2002 Dec;25(12):2165-71.
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title x funding provides necessary services and reduces healthcare
costs
Title X is an important source of funding for ensuring reproductive
health benefits including both contraceptive and preventive services to
women. In 2015, a study found that Title X-funded health centers
prevented 822,000 unintended pregnancies, resulting in savings of $7
billion to federal and state governments. Offering affordable access to
contraception can have a measurable impact on these costs. For every
public dollar invested in contraception, short-term Medicaid
expenditures are reduced by $7.09 for the pregnancy, delivery, and
early childhood care related to births from unintended pregnancies,
resulting in savings of $7 billion to federal and state governments.\7\
Title X is the main point of care for low income, under- or un-insured,
adults and adolescents for affordable contraception, cancer screenings,
sexually transmitted disease testing and treatment, and medically-
accurate information on family planning options. However, to provide
these services to the over 4 million people who depend on Title X-
funded centers, Title X is significantly underfunded.
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\7\ Frost JJ, et al., Publicly Funded Contraceptive Services at
U.S. Clinics, 2015, New York: Guttmacher Institute, 2017.
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fiscal year 2022 funding requests
In conclusion, to avoid loss of promising research opportunities,
allow budgets to keep pace with inflation, support our public health
infrastructure, and assure high-quality, evidence-based, and patient-
centered family planning care, the Endocrine Society recommends that
the Subcommittee provide at least the following funding amounts through
the FY 2022 Labor, Health and Human Services, Education, and Related
Agencies appropriations bill:
--$46.1 billion for the National Institutes of Health
--$10 billion for the Centers for Disease Control and Prevention
--$737 million for Title X
______
Prepared Statement of the Entomological Society of America
The Entomological Society of America (ESA) respectfully submits
this statement for the official record in support of funding for
vector-borne diseases (VBD) research at the U.S. Department of Health
and Human Services (HHS). ESA joins the research community by
requesting $46.1 billion in fiscal year (FY) 2022 for the National
Institutes of Health (NIH), including increased support for vector-
borne disease (VBD) research at the National Institute of Allergy and
Infectious Diseases (NIAID); $10 billion for the Centers for Disease
Control and Prevention (CDC), including investments in the budgets for
VBD, global health, and core infectious diseases; and robust funding
for the Institute of Museum and Library Services (IMLS), including
$42.7 million for the Office of Museum Services.
ESA urges the subcommittee to support VBD research programs that
incorporate the entomological sciences as part of a comprehensive
approach to addressing infectious diseases. These efforts can help
mitigate the enormous impact that insect carriers of disease have on
human health. NIH, the nation's premier medical research agency,
advances human health by supporting research on basic human and
pathogen biology and by developing prevention and treatment strategies.
Cutting-edge research in the biological sciences, including in the
field of entomology, is essential for addressing societal needs related
to environmental and human health. Many species of insects and
arachnids, including ticks and mites, are carriers or vectors of an
array of infectious diseases that threaten the health and well-being of
people worldwide. This threat impacts citizens in every U.S. state and
territory, as well as military personnel serving at home and abroad.
The mosquitoes that carry and transmit diseases are responsible for
more human deaths than all other animal species combined, including
other humans.\1\ VBD can be particularly challenging to manage due to
insect and arachnid mobility and their propensity to develop pesticide
resistance. Further, effective preventative treatments, including
vaccines, are not available for most VBD.
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\1\ https://www.gatesnotes.com/Health/Most-Lethal-Animal-Mosquito-
Week.
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Within NIH, NIAID conducts and supports fundamental and applied
research related to understanding, preventing, and treating infectious
diseases. The risk of emerging infectious diseases grows as global
travel increases in speed and frequency and as environmental conditions
conducive to population growth of vectors, like mosquitoes and ticks,
continue to expand globally. Entomological research to understand and
characterize the relationships between insect vectors and the diseases
they transmit is essential to enable scientists to reliably monitor and
predict outbreaks, prevent disease transmission, and rapidly diagnose
and treat diseases. For example, NIAID-funded researchers are working
to understand how common prevention tools like mosquito repellent work
at the molecular level. Although topical mosquito repellents such as
DEET are a popular tool for preventing mosquito bites and mosquito-
borne diseases like malaria, the mechanism they use to repel mosquitoes
is not understood. Using grant funding from NIAID, researchers from
Johns Hopkins University have determined that DEET is an effective
mosquito repellent because it masks human odors from female
mosquitoes.\2\ Researchers can use these findings to develop similar
safe, low-cost mosquito repellents to prevent mosquito bites, reducing
the burden of mosquito-borne diseases.
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\2\ https://www.sciencedirect.com/science/article/abs/pii/
S0960982219311674.
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ESA requests robust support for CDC programs addressing VBD and
support for the Centers of Excellence on VBD as authorized by the Kay
Hagan Tick Act in 2022 and beyond with at least $10 million per year as
well as $20 million for the Epidemiology and Laboratory Capacity (ELC)
program. CDC, serving as the nation's leading health protection agency,
conducts research and provides health information to prevent and
respond to infectious diseases and other global health threats. Within
the core infectious diseases budget of CDC, the Division of Vector-
Borne Diseases (DVBD) aims to protect the nation from the threat of
viruses, bacteria, and parasites transmitted primarily by mosquitoes,
ticks, and fleas. DVBD's mission is carried out by a staff of experts
in several scientific disciplines, including entomology.
CDC plays a key role in tracking new and emerging diseases, as well
as in supporting health care professionals in identifying and
diagnosing these diseases. From 2016 to 2017, there was a 46% increase
in reported cases of a group of tick-borne diseases known as spotted
fever rickettsioses (spotted fevers), which includes the notably fatal
Rocky Mountain spotted fever (RMSF).\3\ Disability and death from RMSF
are preventable if the antibiotic doxycycline is administered within
the first five days of illness: without treatment, 1 in 5 RMSF cases
lead to death.\4\ Importantly, spotted fevers have non-specific
symptoms, and fewer than 1% of the spotted fever cases reported in
2016-2017 had sufficient laboratory evidence for diagnosis. In response
to this issue, the CDC has created a first-of-its-kind education module
that will help healthcare providers recognize the early symptoms of
RMSF and distinguish it from other diseases, enabling affected patients
to get the life-saving treatment they need as quickly as possible.\5\
CDC funding is crucial in the development of this and other educational
tools that equip health care providers to effectively combat tick-borne
diseases.
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\3\ https://www.ncbi.nlm.nih.gov/pubmed/?term=30969821.
\4\ https://www.cdc.gov/media/releases/2019/p0513-rocky-mountain-
spotted-fever-training.html.
\5\ https://www.cdc.gov/rmsf/resources/module.html.
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Using funding appropriated during the 2016 Zika crisis to help
respond to that emergency and develop the necessary future workforce,
CDC awarded $50 million to five universities to establish regional
Centers of Excellence (COE) to address existing and emerging VBD. The
five centers, for which current funding expires in 2021, generate
research, education, outreach, and capacity to enable appropriate and
timely local public health action for VBD throughout the U.S. The COE
model requires collaboration between the research institutions and the
local and regional departments of health (DOH), important relationships
which have not generally arisen organically. This is critical given
significant regional differences in vector ecology, disease
transmission dynamics, and resources.
The Kay Hagan Tick Act also expands authorized support for the ELC
program, critical to supporting state and local departments of health
vector surveillance and management. For the last several years, the CDC
has only been able to fund a third of the $50 million in requests they
receive from states to meet these needs. ESA supports fully funding the
$20 million authorized in the Kay Hagan Tick Act to support the ELC
grants.
ESA requests robust funding for IMLS, including no less than $42.7
million for the Office of Museum Services in FY 2022. The services and
funding provided by IMLS are critical in several areas--research
infrastructure, workforce development, and economic impact. IMLS
provides for the expansion of collections capabilities at American
museums, which are key for the identification, documentation of
locations, and classification of entomological species. The 21st
Century Museum Professionals Program provides opportunities for diverse
and underrepresented populations to become museum professionals,
expanding participation in an industry with an annual economic
contribution of $21 billion. Museums are critical to the public
understanding of science through exhibits and programs, and in so
doing, support science education as an integral part of the nation's
educational infrastructure. They also make significant long-term
contributions to economic development in their local communities.
Thank you for the opportunity to offer the Entomological Society of
America's support for NIH, CDC, and IMLS research programs.
[This statement was submitted by Michelle S. Smith, BCE, President,
Entomological Society of America.]
______
Prepared Statement of the Epilepsy Foundation
summary of fiscal year 2022 appropriations recommendations
_______________________________________________________________________
--Please provide $10 billion for the Centers for Disease Control and
Prevention (CDC) including:
--$13 million for the National Center for Chronic Disease
Prevention and Health Promotion's Epilepsy program, an
increase of $2.5 million over FY 2021.
--$5 million for the CDC's National Neurological Conditions
Surveillance System (NNCSS).
--Please provide at least $46.1 billion for the National Institutes
of Health (NIH).
--Please provide proportional increases for various NIH Institutes
and Centers, including the National Institute of
Neurological Disorders and Stroke (NINDS).
_______________________________________________________________________
Thank you for the opportunity to submit testimony on behalf of the
Epilepsy Foundation and the people with the epilepsies whom we serve.
Chairwoman Murray, Ranking Member Blunt, and distinguished members of
the subcommittee, we deeply appreciate the robust investments in
medical research and public health programs over recent years which are
helping us better understand and treat the epilepsies and better
support people with epilepsy and their families day-to-day. As you and
your colleagues work on appropriations for FY 2022, please continue
this commitment and provide timely investments in the NIH and public
health and research programs at the CDC. Thank you for your time and
for your consideration of these requests.
about the epilepsy foundation
The Epilepsy Foundation is the leading national voluntary health
organization that speaks on behalf of the approximately 3.4 million
living with epilepsy and seizures. We foster the wellbeing of children
and adults affected by seizures through research programs, educational
activities, advocacy, and direct services.
about the epilepsies
Epilepsy is a disease or disorder of the brain which causes
reoccurring seizures affecting a variety of mental and physical
functions. It is a spectrum disease comprised of many diagnoses
including an ever-growing number of rare epilepsies. There are many
different types of seizures and varying levels of seizure control.
3.4 million Americans live with active epilepsy including 470,000
children and teenagers. Thirty to forty percent of people with epilepsy
live with uncontrolled seizures despite available treatments. Delayed
recognition of seizures and inadequate treatment increase a person's
risk of subsequent seizures, brain damage, disability, and death.
Epilepsy imposes an annual economic burden of $19.4 billion on the
country.
Please provide $10 billion for CDC including $13 million for CDC's
Epilepsy program.
The Institute of Medicine's (IOM) report on epilepsy, Epilepsy
Across the Spectrum: Promoting Health and Understanding, identifies the
Epilepsy Foundation and the CDC as leaders in addressing many of its
national recommendations to eliminate stigma, improve awareness and
education and better connect people with the epilepsies to health and
community services. The CDC Epilepsy program is the only public health
program specifically related to epilepsy with a national scope and
community programs. Focus areas requiring continued and increased
investment include:
--In FY 20, 481 law enforcement and first responders, 5,033 school
nurses, 214,702 school personnel, and 4,071 students have been
trained on seizure recognition and seizure first aid. On-demand
training modules are being developed to scale up training of
these key, frontline community members.
--10,000 people have been certified in seizure first aid, though more
focus is needed on rural and ethnically and racially diverse
communities as nearly 40% of persons diagnosed with epilepsy
are African American or Hispanic and many people with epilepsy
in those communities have poorer health outcomes.
--To improve care in rural and underserved communities, Project ECHO
has educated more than 400 healthcare providers about managing
epilepsy, though more focus is needed on management of severe,
drug-resistant epilepsy and quality of care improvement
methods.
--60 community health workers in Texas and Illinois have been trained
to implement self-management programs resulting in improved
health outcomes for people with epilepsy. More funding could
scale up this evidence-based training in other states.
--By screening and addressing barriers to medication adherence, an
Epilepsy Learning Healthcare System is reducing healthcare
utilization and costs.
--Mental health screenings have been implemented and people with
epilepsy are being connected to self-management programs that
prevent and decrease depression since people with epilepsy at
increased risk for depression and anxiety.
Testimonials from Participants in CDC Epilepsy Program-Funded Efforts
Margaret, Fairfield, CT: ``Participating in HOBSCOTCH and learning
more about epilepsy and the brain helped me realize this diagnosis is
not something to be afraid or embarrassed of. By facing and dealing
with my diagnosis head on, I can take control of certain aspects of
epilepsy and improve my quality of life. HOBSCOTCH taught me strategies
that I now use every day to improve my memory.''
Kelsey, Seattle, WA: ``During the 8 weeks that I participated in
the PACES program, I learned a lot valuable information and had a
wonderful time meeting other people experiencing similar struggles as
me. I loved that the program integrated both a personable, solidarity
like approach while providing evidence-based information with the most
up to date epilepsy research. Having had epilepsy for over 15 years, I
thought that I had a strong grasp on most epilepsy topics. However, the
PACES program brought up different areas which I hadn't considered
before and I found really useful for personal introspection and to
share with other people in my life. I believe the PACES program is a
wonderful opportunity for individuals who both have either been
recently diagnosed or lived with epilepsy for a long time to share
their own experiences in a way that might change another person's life
and to learn important facts about the condition.''
Nancy Tindell, Geneva County, Alabama: After taking the school
nurse seizure training program myself in 2020, I strongly encouraged
all school nurses and school personnel in my county to take the course
because even I, as a nurse, learned a lot about both seizure types, new
rescue therapies on the market and more. As a school nurse in a small
town in Alabama, I am thankful for the support and trainings that
empower us to support the students with seizures and epilepsy in our
classroom and extracurricular settings.
Jon D. Brown, Founder and Chief Advocate, Black Men's Health,
Tallahassee, FL: We had an opportunity to collaborate with the Epilepsy
Foundation to not only bring awareness to and educate on the topic of
Epilepsy, but together we were able to specifically leverage June, as
Men's Health Month, to focus on a Seizure First Aid Certification
Training. Throughout virtual discussions with Lowell Evans, who spoke
on ``Living with Epilepsy While Changing the World,'' and Michael
Brown, who spoke on ``Are You Certified in Epilepsy First Aid? You
Should and Can Be,'' I learned so much vital information that provided
me new-found awareness, information, education, and confidence (key!)
to act if I am to find myself in the presence of someone having a
seizure. And, the subsequent training, facilitated by Michael Brown and
Luis Garcia, emphasized that this scenario might likely happen, as we
learned that 1 in 10 people will experience a seizure in their
lifetime. Mind-blowing, life-changing, and potentially life-saving
information; important conversations that I am committed to continue
having for broader reach throughout communities of color.
Fernando A., Columbus, Indiana: Project Uplift was very helpful to
help my wife understand my daily struggles. It helped me learn ways to
cope with my anxiety and to better communicate my thoughts and needs. I
feel that Project Uplift is a very valuable resource to spread
knowledge and awareness about the epilepsy community. I know that if
the program continues, it will help reduce the stigma around what it
means to be epileptic and create a safe community for those of us who
just want to feel heard and understood.
Also as part of the $10 billion for the CDC, please provide $5 million
for the CDC's National Neurological Conditions Surveillance
System.
In 2016, Congress authorized the CDC to establish the NNCSS and it
first received funding in FY 2019. The CDC is initially focusing on MS
and Parkinson's, in order to learn through the process before extending
to other neurological conditions. Extending to additional neurological
conditions such as the epilepsies is contingent on continued funding
for this program so the Foundation requests $5 million for the NNCSS in
FY 2022.
Please provide at least $46.1 billion for NIH along with proportional
increases for various NIH Institutes and Centers, including
NINDS.
As a result of sustained investment in NIH, the epilepsy research
portfolio has grown from about $150 million in FY 2017 to over $200
million in FY 2020. These resources have fueled scientific advancement
and led to support for a variety of research initiatives including:
Epilepsy Centers without Walls, The Epilepsy 4,000 (Epi4K)
collaborative, The Center for Sudden Unexplained Death in Epilepsy
(SUDEP) Research, The Epilepsy Bioinformatics Study for
Antiepileptogenic Therapy (EpiBiosS4Rx), The Channelopathy Associated
Epilepsy Research Center (CAREC), The Epilepsy Multiplatform Variant
Prediction (EpiMVP) Center.
https://www.ninds.nih.gov/Current-Research/Focus-Disorders/Epilepsy
Much more can be done though, particularly in the area of bold
cross-cutting initiatives and multi-center efforts. For FY 2022, we ask
the subcommittee to include key committee recommendations, like the
language below, to encourage additional epilepsy research in emerging
areas.
national institute of neurological disorders and stroke
Epilepsy.--The Committee notes the significant opportunities for
the NINDS to advance research on the epilepsies through multi-center,
multidisciplinary approaches like the Epilepsy Centers Without Walls
that help address the need for biomarkers of epilepsy and precision
medicine for new treatments and prevention for etiologically-defined
populations. This approach is also suited for nation-wide, coordinated
clinical and translational research frameworks to advance disease
modifying or prevention strategies for the epilepsies.
The Epilepsy Foundation thanks the subcommittee for its
consideration of these requests. If you have any questions, please
contact me.
[This statement was submitted by Laura Weidner, Esq., Vice
President,
Government Relations & Advocacy.]
______
Prepared Statement of Evermore
Chairwoman Murray, Ranking Member Blunt, and members of the
Committee, thank you for the opportunity to provide testimony
pertaining to fiscal year (FY) 2022 appropriations for the Centers for
Disease Control and Prevention (CDC). Your leadership has resulted in
major advances in the health and wellbeing of Americans, as well as
ensuring that our taxpayer dollars are appropriated to our nation's
most pressing health and human needs.
I submit this testimony on behalf of Evermore, a nonprofit
dedicated to making the world a more livable place for bereaved
families by raising awareness of the consequences and implications of
bereavement for society, advancing sound research that drives policy
and program investments, and advocating on behalf of bereaved families
for whom very limited legal protections are available in the aftermath.
The purpose of my testimony today is to alert you to an emerging public
health concern--bereavement--and its impact on millions of families
throughout the nation. Bereavement shares a powerful intersectionality
with multiple national public health emergencies, including COVID-19,
overdose, homicide, and suicide. As such, bereavement plays a key
gatekeeping role in determining whether we as a nation can turn the
corner on these ongoing public health crises towards national recovery
and wellbeing. This watershed moment offers us a rare opportunity to
effect long-needed and long-awaited systemic changes. These changes can
bring together a diverse array of seemingly disconnected, separately
raging crises to support our nation's grieving individuals, families,
and communities; compassionately lighten the burden of bereavement that
encumbers and shortens so many lives, and re-enable them to reach their
full potential.
Bereavement is a pernicious social concern threatening nearly every
aspect of family wellbeing and solvency for millions across the
country. The unexpected death of a loved one poses a dual threat to our
national well-being, as it is both among the most common major life
stressors, and the single worst lifetime experience, reported by
Americans in national surveys. Losing a loved one is not only a
personal tragedy, but casts a long shadow that can extend for decades
as it places surviving parents, children, siblings, and spouses at
significant risk for impaired health, premature death, and
underachievement. Some additional risks include serious mental health
disorders, teen pregnancy, violent crime involvement, youth
delinquency, substance abuse, diminished academic attainment,
diminished lifetime income, and less purpose in life, among many
others.
Perhaps most concerning, our national life expectancy--an index of
overall population health--has dropped by more than one full year. This
last happened nearly 80 years ago following the United States' entry
into World War 2. The implications of these statistics are sobering:
They not only indicate that many middle-aged people of child-bearing
and child-rearing years are dying, but that many children and
adolescents are losing their parents, grandparents, aunts, uncles, and
mentors. Recurring bereavement under tragic and often-traumatic
circumstances has now become a commonplace fact of life for many US
residents. Further, COVID and our other spiking epidemics have set back
progress in closing the racial health disparities gap by some 20 years.
Racial inequalities in bereavement are magnified across the life course
as Black Americans are more likely than White Americans to experience
the death of children, spouses, siblings, and parents. Black Americans
are three times as likely as White Americans to have two or more family
members die by the time they reach the age of 30. Black children are
three times as likely to lose a mother and more than twice as likely to
lose a father by age 10 when compared to White children.
To facilitate and inform future policymaking and national
investments, as well as develop an evidenced-based bereavement care
response system, Evermore encourages a budget increase of $2.5 million
in CDC's Office of Surveillance, Epidemiology, and Laboratory Services/
Division of Behavioral Health to collect bereavement prevalence and
incidence data via its Behavioral Risk Factor Surveillance Survey
(BRFSS). BRFSS is the nation's premier survey tool collecting data from
400,000 adults living in the 50 states, the District of Columbia, and
three U.S. territories. It is the largest continuously-conducted health
survey in the world.
The CDC is one the nation's most-trusted sources of data and
evidence on population and public health. Our nation requires
consistent and reliable data on the prevalence and sequelae of
bereavement on which to formulate sound policy and practice. Today, the
CDC collects mortality data, but not data pertaining to the bereaved
families who survive these death events, and what the ramifications
are. With five million individuals losing a loved one to COVID-19,
including an estimated 46,000 children who lost a parent, the need for
sound data collection to frame a federal response has never been
greater. Indeed, we have relied on private researchers--including
Ashton Verdery, Ph.D. of The Pennsylvania State University and Emily
Smith-Greenaway of the University of Southern California--to provide
these estimation models because the federal government does not measure
bereavement exposure.
By extension, bereavement prevalence and incidence for homicide,
suicide or overdose are currently unavailable, leaving us with no
accurate means of capturing its impact (perhaps better designated as
shockwaves) on individuals, families, and communities. This is a major
missed opportunity for our social and health systems to surveil,
monitor, and learn from our national epidemics and mount an effective
response. Adding bereavement exposure to BRFSS would provide key
demographic data, trends by race and geography, resulting in both a
better understanding of the scope of the problem and informing future
policymaking and program priorities and investments.
In 2019, Toni Miles, M.D., Ph.D. of the University of Georgia
piloted three bereavement exposure questions in Georgia's BRFSS module,
prior to the COVID-19 epidemic (see Figure 1). Her work found that 45
percent of Georgia BRFSS respondents were bereaved in the previous two
years. Extrapolating this figure to the overall state population, she
estimates that 3.7 million Georgian adults were recently bereaved. Her
work also estimates that approximately 400,000 Georgia adults had two
or more close family members die. African American adults are at
particular risk, with 58 percent reporting a loss. Those in their prime
working years are affected, with 48 percent of adults ages 35-64
experiencing a loss. Preliminary evidence indicates that bereavement
exposure may undermine capacity to work; 53 percent of those newly out
of work had experienced a family death.
Dr. Miles and her team found that persons who experienced any
family loss in the past two years were at a heightened risk of
reporting poor health, as well as physical and mental health problems
over the past two weeks within taking the survey. Persons experiencing
three or more losses were at the greatest risk of multiple health
concerns, ranging from obesity to binge drinking, relative to those
with no losses.
additional justification for requests
Publicly-available bereavement dataset. We request the creation of
a publicly available bereavement dataset enabling social and health
scientists to extrapolate risk factors and potential implications for
U.S.-based populations. Researchers will be able to examine
interrelationships between exposure and outcomes, ask new research
questions and begin to integrate this data into their existing research
endeavors intended to help individuals reach their fullest potential.
To that end, these data may influence CDC's Healthy People 2030 goals.
CDC's Health US, 2022. We request a special highlight section in
CDC's 2022 health status report to the nation, Health, United States.
This report presents key highlights and findings from federal health
data systems.
conclusion
To date, there is no national dataset capturing bereavement
prevalence and incidence as our nation is facing unprecedented loss.
Unequivocally, COVID-19 has reshaped our national landscape and is a
seminal moment detailing how lack of quality bereavement care taxes
individuals, families and the nation. Bereavement and its unintended
outcomes are inextricably linked to many of our federal health agencies
missions, priorities, and programs.
With more than millions of individuals in the United States
suffering the loss of a loved one to COVID-19 and countless others who
have lost a loved one to suicide, homicide, overdose, and chronic
disesaes like cancer and Alzheimer's disease, combined with the growing
evidence base about the profound long-lasting effects of bereavement on
individuals and community health, bereavement (as a marker of risk) and
quality bereavement care should be a priority for CDC and the federal
government. Bereavement exposure and by extension its care is an
essential element to any comprehensive public health strategy.
Thank you for the opportunity to present this testimony on behalf
of millions of bereaved Americans and thank you for your continued
leadership.
Sincerely.
[This statement was submitted by Joyal Mulheron, Executive
Director, Evermore.]
______
Prepared Statement of the Evidence-Based Leadership Collaborative
Chair Murray and Ranking Member Blunt, and members of the
Subcommittee, first, thank you for the opportunity to submit testimony
to the Subcommittee to outline critical federal funding priorities for
FY 2022. As we emerge from the health and economic crisis of the last
year, the funding decisions that federal lawmakers make in FY 2022 will
determine whether we have learned from the devastating consequences of
the COVID-19 pandemic, or whether we default to a perilous status quo.
It is with optimism that we will collectively improve upon the tragic
lessons of the coronavirus crisis that we submit our funding requests
for FY 2022.
In this sprit, we sincerely hope that Congressional Appropriators
will recognize the value of evidence-based programs (EBPs) to promote
health and prevent disease among older adults and make investments that
increase support for, and expand access to, these vital activities. On
behalf of the Evidence-Based Leadership Collaborative (EBLC)--a 501c3
organization that represents EBP developers, administrators, and
providers with more than 200 combined years in developing, evaluating,
scaling, implementing, and sustaining EBPs--we urge Subcommittee
Members to include relatively modest, but meaningful, funding increases
for the following programs within the Administration for Community
Living (ACL):
--$50,000,000 for Older Americans Act Title III D, Preventative
Health Services
--$16,000,000 for Older Americans Act Title IV, Chronic Disease Self-
Management Education (CDSME) Programs
--$10,000,000 for Older Americans Act Title IV Falls Prevention
Programs
Additionally, within the Centers for Disease Control and Prevention
(CDC), we urge the Subcommittee to make important additional
investments in chronic disease prevention programs, which are
especially important given the significant impact of COVID-19 on older
adults living with multiple chronic diseases.
These funding requests align with those of other national aging
advocacy organizations and coalitions that focus on disease prevention,
health promotion, and home and community-based services (HCBS)
provision for older Americans, including the National Council on Aging
(NCOA), the National Association of Area Agencies on Aging (n4a), and
the Leadership Council of Aging Organizations (LCAO).
the case for evidence-based programing for older americans
Evidence-based programs offer proven ways to promote health and
prevent disease among older adults. These interventions have a decades-
long track record of improving health and reducing costs when delivered
within community settings across the country. Community and home-based
delivery means improved access to quality care for older adults who are
traditionally underserved, by organizations that also address those
social needs that drive poor health and costs of care. These evidence-
based programs include, but are not limited to:
--the Chronic Disease Self-Management suite of programs, which teach
individuals how to manage ongoing health conditions;
--a Matter of Balance, EnhanceFitness, and Fit & Strong!, which
increase awareness of and target interventions to help prevent
fall-related injuries;
--Healthy IDEAS and PEARLS, which help to address and identify the
underlying symptoms of depression; and
--Healthy MOVES and other programs focused on improving physical and
emotional health through physical activity.
All of these programs, which are represented by the Evidence-Based
Leadership Collaborative, meet the Administration for Community
Living's criteria for the highest level of evidence. In addition to
ACL, the Centers for Disease Control and Prevention Arthritis Program,
Substance Abuse and Mental Health Services Administration's (SAMHSA)
National Registry of Evidence-Based Programs, and the Agency for
Healthcare Research and Quality Innovations Exchange recommend these
programs and find them to be the strongest of evidence-based programs.
The scale and scope of the challenges that the suite of EBPs
address demonstrates the importance of investing in effective
interventions. For example, chronic diseases are the leading causes of
death and disability in the U.S., whose costs constitute 90 percent of
the nation's $3.8 trillion in health expenditures. Older Americans are
disproportionately affected by chronic conditions; 80 percent have at
least one chronic condition, and nearly 70 percent of Medicare
beneficiaries have two or more. Older adults living with chronic
conditions, particularly Black, Indigenous, and other Persons of Color
(BIPOC), were more vulnerable to COVID-19 hospitalizations and deaths,
highlighting inequities in both health outcomes and access to quality
care.
Furthermore, falls are the primary cause of injuries and deaths
from injuries among older adults. Each year, an estimated one in four
older adults falls. Annually, more than three million fall injuries are
treated in emergency departments, resulting in nearly 800,000
hospitalizations. Yearly spending to treat injuries resulting from
falls totals $50 billion, 75 percent of which is paid for by Medicare
and Medicaid. These costs are expected to exceed $101 billion by 2030.
The pandemic exacerbated these challenges and contributed to other
emerging widespread concerns. For example, social isolation and
loneliness-a major contributor to poor physical, behavioral, and
cognitive health-increased drastically for high-risk older Americans
adhering to long-term stay-at-home orders and community shut-downs. The
spike in social isolation and loneliness among older adults also
spurred declines in physical functioning for many older Americans
because of reduced access to community supports and evidence-based
programs health promotion programs.
opportunities to expand evidence-based health promotion and disease
prevention programs with increased federal investments
Despite the growing and widespread barriers to EBP delivery during
COVID-19, program developers and community-based providers were quick
to adapt to the new reality and adopt program delivery models suitable
to a virtual world. Rapidly pivoting previously in-person programs to
online and telephonic delivery methods ensured that many of these
trusted, proven, and popular health promotion and disease prevention
strategies could continue and remain accessible during the health
crisis. Additionally, adapting EBPs to remote delivery demonstrated
long-term potential to address program participation barriers for
especially high-risk and historically marginalized populations
including rural and home-bound older adults.
Increasing FY 2022 investments in evidence-based disease prevention
and health promotion programs will allow providers to expand their
reach to older Americans whose health conditions worsened because of
the prolonged pandemic. Increased investments will also allow EBP
interventions to continue to offer, expand, and improve upon remote
program delivery options to overcome long-standing barriers for older
adults lacking access to in-person programing and to reaching
underserved communities with culturally and linguistically appropriate
services. This opportunity is a potential paradigm shift for these
proven, trusted, cost-effective interventions.
Given the potential to expand these programs as we recover from the
pandemic, we respectfully request that the Subcommittee prioritize the
following FY 2022 federal investments to support these important
disease prevention and health promotion programs.
oaa title iii d preventive health services
Title III D of the Older Americans Act delivers evidence-based
health promotion and disease prevention programs to prevent or better
manage the conditions that most affect quality-of-life, drive up health
care costs and reduce an older adult's ability to live independently.
However, investments have not been sufficient to ensure the diverse
array of proven, cost-effective interventions can be implemented in
communities nationwide, nor do they allow the to-date underfunded
network to amass the critical evidence-based data lawmakers seek.
Additional resources are needed to maintain the new reach and means of
both in-person and remote delivery so older adults maintain access to
these key services. We urge Congress to double appropriations funding
for OAA Title III D programs in FY 2022 to $50 million.
oaa title iv chronic disease self-management education (cdsme)
CDSME is a low-cost, evidence-based disease management intervention
which studies show to be effective at helping people with all types of
chronic conditions adopt healthy behaviors, improve health status, and
reduce use of hospital stays and emergency room visits. Prevention and
Public Health Fund allocations to ACL for CDSME have remained at $8
million since FY 2016, supporting over 14,000 community-based delivery
sites which have provided services to more than 550,000 individuals.
However, given that nearly 200 million people report having a chronic
disease, the reach of these programs has been only 0.25 percent of the
full population reach potential. We urge appropriators to increase FY
2022 funding for these programs to $16 million to expand access to
evidence-based, cost-effective chronic disease management programs to a
greater number of states and older adults in need across the country.
oaa title iv falls prevention
Evidence-based fall prevention programs offer cost-effective
interventions by reducing or eliminating risk factors, promoting
behavior change, and leveraging community networks to link clinical
treatment and community services. These programs have been shown to
reduce the incidence of falls by as much as 55 percent and produce a
return on investment of as much as 509 percent. In fact, in an October
2019 report on falls prevention, the Senate Special Committee on Aging
recommended continued investment and expanded access to EBPs aimed at
mitigating the risk of falls among older adults. Despite this
bipartisan support, falls prevention has been flat funded while the
incidence and costs of falls continues to climb. Therefore, we urge
your Subcommittee to increase the investment in these cost-effective
programs to $10 million to make these programs more widely available to
at-risk older Americans in every community.
In closing, these vital federal efforts that support health
promotion and disease prevention interventions across the country have
a profound impact on the quality-of-life of older Americans. On behalf
of myself, the Evidence-Based Leadership Collaborative, and other
national aging advocates, I implore you and your Subcommittee to
support FY 2022 funding levels for these programs that recognize the
value of, and expand access to, proven solutions for older Americans.
[This statement was submitted by Paul Hepfer, CEO, Project Open
Hand &
Evidence-Based Leadership Collaborative Board Chair.]
______
Prepared Statement of the Federal AIDS Policy Partnership's Research
Work Group
On behalf of the Federal AIDS Policy Partnership's Research Working
Group, we thank Chairwoman Senator Murray, Ranking Member Senator
Blunt, and members of the subcommittee for the opportunity to submit
testimony to the Senate LHHS Subcommittee on Fiscal Year 2022 (FY 2022)
Appropriations for the National Institutes of Health (NIH) in regards
to protecting, strengthening, and expanding our nation's HIV/AIDS
research agenda. The Research Work Group (RWG) of the Federal AIDS
Policy Partnership (FAPP) is a coalition of more than 60 national and
local HIV/AIDS research advocates, patients, clinicians and scientists
from across the country. Our goal is to advance and support U.S.
leadership to accelerate progress in the field of HIV/AIDS research.
The FAPP RWG urges the subcommittee to recommend a FY 2022 budget
request level of at least $46.1 billion for the NIH consistent the
request of the Ad Hoc Group for Medical Research. We also ask that
$3.845 billion be allocated for HIV research at the NIH in FY 2022,
which is the research need identified by the Office of AIDS Research in
their Congressionally mandated FY 21 Professional Judgment Budget.
Public investments in health research via NIH have paid enormous
dividends in the health and wellbeing of people in the U.S. and around
the world, particularly for people living with, or vulnerable to, HIV.
NIH funded AIDS research has supported innovative basic science for
better drug therapies, and evidence-based behavioral and biomedical
prevention interventions which have saved and improved the lives of
millions. NIH funding has contributed to over 210 approvals for a range
of novel therapeutics between 2010 through 2016, with new anti-
infectives for HIV and HCV receiving the second largest fraction of
those approvals. Additionally, NIH support was crucial in the
development of pre-exposure prophylaxis (PrEP), an HIV prevention tool
that is upwards of 99% effective in preventing sexual transmission.
NIH-supported HIV research is now critical to advancement of possible
treatments and several vaccines against COVID-19.
HIV research advances at the NIH hold the potential to end the AIDS
epidemic, as well as update prevention approaches and improve outcomes
along the treatment cascade--a cornerstone of the initiative to End the
HIV Epidemic in the U.S. In addition, the average age of people living
with HIV in the United States is increasing, so it also remains
critically important to make substantial investments in research on co-
morbidities and new antiretroviral therapies. NIH research is critical
to ensuring that aging population stays healthy and virally suppressed.
Since 2003, funding for NIH HIV research has failed to keep up with
our existing research needs--damaging the success rate of approved
grants and leaving very little money to fund promising new research--
despite increases to the overall NIH budget. According to the
Biomedical Research and Development Price Index (BRDI)--which
calculates how much the NIH budget must change each year to maintain
purchasing power--between FY 2003 and FY 2020, the NIH budget in
constant dollars according to BRDI will have declined by almost half.
Investment by the NIH has transformed the HIV epidemic from a
terrible, untreatable disease to a chronic condition that can be
managed through once-a-day drug regimens. Now is the time to increase
investment for the NIH to finish the job and end the HIV epidemic
through strategic, science-based interventions. NIH funding of HIV/AIDS
research provides an example of innovation at work where investment in
basic and translational research, working in partnership with industry
and community, can move quickly to develop solutions. NIH investments
in HIV/AIDS research add value by seeding ideas later taken up in
industry partnerships and creating innovation incubators for important
medical advances with significant health impact.
Federal support for HIV/AIDS research has also led to new
treatments for other diseases, including cancer, COVID-19, heart
disease, Alzheimer's, hepatitis, osteoporosis, and a wide range of
autoimmune disorders. Several HIV/AIDS treatments have been researched
as treatments for the novel coronavirus--saving months of research time
and, in the process, potentially countless lives. Coronavirus vaccine
research is now ongoing using platforms and technology, such as Ad26
and mRNA, previously developed for use as an HIV vaccine.
Robust funding for NIH overall enables research universities to
pursue scientific opportunity, advance public health, and create jobs
and economic growth. NIH funding puts approximately 300,000 scientists
to work at research institutions across the country. According to NIH,
each of its research grants creates or sustains six to eight jobs and
NIH-supported research grants and technology transfers have resulted in
the creation of thousands of new independent private sector companies.
The race to find better treatments and a cure for cancer,
Alzheimer's, heart disease, HIV/AIDS, and other diseases, and for
controlling global epidemics like AIDS, tuberculosis, coronavirus, and
malaria, all depend on a robust long-term investment strategy for
health research at NIH. There can be no innovation without reliable and
adequate research funding. Congress should ensure the nation does not
delay vital HIV/AIDS research progress. We must protect HIV/AIDS
research funding to sustain research capacity and maintain our
worldwide leadership in HIV/AIDS research and innovation.
To that end, we urge the subcommittee to consider a needed increase
to the overall FY 2022 budget request level of at least $46.1 billion
for the National Institutes of Health (NIH) consistent with the request
of the Ad Hoc Group for Medical Research. While this increase may get
us closer to meeting the OAR By-Pass Budget Estimate for FY 2022, we
ask the committee direct that increased funding be allocated for HIV
research at the NIH in FY 2022. We urge the subcommittee to consider
approaches to ensure the HIV research budget receives increases
alongside other important and intersecting biomedical research at NIH.
In conclusion, the RWG calls on Congress to continue the bipartisan
federal commitment towards combating HIV as well as other chronic and
life-threatening illnesses by increasing funding for NIH in FY 2022. A
meaningful commitment towards maintaining the U.S. pre- eminence in HIV
research and fostering innovation cannot be met without prioritizing
the research investment at NIH that will lead to tomorrow's lifesaving
vaccines, treatments, and cures that are needed to end the HIV epidemic
here and abroad. Thank you for the opportunity to provide these written
comments.
______
Prepared Statement of the Federation of American Societies for
Experimental Biology
My testimony is in support of FY22 funding for the National
Institutes of Health under the Department of Health and Human Services
, Agency Subdivision: National Institutes of Health, Account: 550.
summary
Federal investments in fundamental research have led to remarkable
progress in the biological and biomedical sciences. Basic research was
the groundwork for the speed--months instead of years--in the
development of COVID-19 vaccines, and pre-clinical research, such as
animal studies, has been essential to every step of achieving medical
progress.
Despite Congress' bipartisan support for investing in science,
federal funding for research has not kept pace, posing a threat to our
nation's competitiveness. We face a real threat of losing our edge in
industries such as biotechnology if we do not prioritize increasing
investments in science and building a diverse workforce \1\ The U.S.
spends less on research and development (R&D) than many countries. If
the U.S. is to be prepared to respond to future threats, our scientific
leadership must progress. According to Science Is Us, there is the
added benefit of jobs. STEM supports 69 percent of U.S. gross domestic
product, touches two out of three workers, and generates $2.3 trillion
in tax revenue.\2\
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\1\ NSF Science Indicators 2018.
\2\ STEM and the American Workforce. You've heard it before: STEM
jobs--... | by Science is US | Medium.
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The federal government should commit to robust, predictable, and
sustained funding increases for science agencies.
national institutes of health
The NIH is the nation's largest funder of biomedical research,
providing competitive grants to support the work of 300,000 scientists
at universities, medical centers, independent research institutions,
and companies nationwide. NIH supports biomedical discoveries,
innovations, and treatments that were made possible because of
scientific research using animals.
Congress has renewed its commitment to this critical research
agency, providing robust, sustained, and predictable budget increases
over the last five fiscal years (Table 1).\3\ With these resources, NIH
has accelerated progress across all areas of medical science, including
regenerative medicine, cancer immunotherapy, and neurological
health.\4,5,6\ The agency is also committed to supporting the next
generation of our biomedical research enterprise.\7\
---------------------------------------------------------------------------
\3\ FASEB Federal Funding Data.
\4\ NIH Regenerative Medicine Innovation Project, National
Institutes of Health, Bethesda, MD.
\5\ NCI's Role in Immunotherapy Research, National Cancer
Institute, Bethesda, MD.
\6\ The BRAIN Initiative Summary, National Institutes of Health,
Bethesda, MD.
\7\ NIH Grants and Funding, Next Generation Research Initiative,
National Institutes of Health, Bethesda, MD.
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Though the NIH is in a stronger position than it was a few years
ago, Congress must continue to increase biomedical research funding.
Our nation is confronting public health threats, especially given
global climate change negatively impacting biodiversity and geohealth--
the intersection of biological science, Earth sciences, and ecology--on
mankind. More research will be needed to address increased risks posed
by future pandemics, infectious diseases, and greater exposure to
environmental pollutants.\8\
---------------------------------------------------------------------------
\8\ IPCC AR5 Climate Change 2014, Chapter 11: Human Health:
Impacts, Adaptation, and Co-Benefits.
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In the U.S., we continue to address the needs of an aging
population and obesity.\9,10\ NIH research is developing therapies for
a whole spectrum of age-related disorders.\11\ Obesity impacts 42% of
the U.S. population and increases the likelihood of developing costly
medical conditions.\12\
---------------------------------------------------------------------------
\9\ https://www.census.gov/newsroom/press-releases/2018/cb18-41-
population-projections.html.
\10\ NIDDK Health Information.
\11\ Aging Well in the 21st Century: Strategic Directions for
Research on Aging, National Institute on Aging, Bethesda, MD.
\12\ CDC Obesity Data.
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Our recommendation of $46.11 billion is $3.2 billion above FY 2021
allowing NIH to continue support for the Next Generation Researchers
Initiative; provide a five percent increase across NIH institutes and
centers; and expand dual purpose research in biomedicine and
agriculture among NIH and other federal agencies.\13\
---------------------------------------------------------------------------
\13\ BILLS-116RCP68-JES-DIVISION-H.pdf (house.gov) pg. 63.
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FASEB FY 2022 Recommendation: at least $46.11 billion for NIH
(chart below):
[This statement was submitted by Ellen Kuo, Associate Director,
Legislative
Affairs, Federation of American Societies for Experimental Biology.]
______
Prepared Statement of the Federation of Associations in
Behavioral and Brain Sciences
Chairwoman Murray, Ranking Member Blunt, and Members of the
Subcommittee:
The Federation of Associations in Behavioral and Brain Sciences
(FABBS) is grateful for the opportunity to submit testimony for the
record in support of the National Institutes of Health (NIH) and the
Institute of Education Sciences (IES) budgets for fiscal year (FY)
2022. FABBS represents twenty-seven scientific societies and over sixty
university departments whose members and faculty share a commitment to
advancing knowledge of the mind, brain, and behavior. For fiscal year
(FY) 2022, FABBS encourages your subcommittee to provide the National
Institutes of Health (NIH) with a budget of at least $52 billion and
the Institute of Education Sciences (IES) within the Department of
Education a budget of $700 million.
Our members are thankful that appropriators were able to secure
$42.9 billion for NIH and over $646 million for IES in FY21. We also
appreciate the supplemental appropriations to NIH and IES included in
COVID-19 response legislation. At NIH, these funds have played a
central role in the pandemic response, not only developing vaccines and
treatments but also supporting behavioral research to inform public
health strategies. At IES, these investments are already helping to
conduct essential research into the learning disruptions caused by the
pandemic and providing educators the tools to chart a path forward for
students. We hope to see similar success funding these agencies' vital
contributions in FY22.
national institutes of health
We sincerely thank the Subcommittee for its diligent work and
considerable increases to NIH in recent years. As members of the Ad Hoc
Group for Medical Research and the Coalition for Health Funding, FABBS
recommends at least $52 billion for NIH in FY 2022. FABBS members
contribute to the NIH mission of seeking fundamental knowledge about
the behavior of living systems and the application of that knowledge to
enhance health, lengthen life, and reduce illness and disability. FABBS
members contribute to the advances in numerous NIH Institutes and
Centers (IC).
FABBS members have a particular interest in the Office of
Behavioral and Social Science Research. OBSSR was created to coordinate
and promote basic, clinical, and translational behavioral and social
science research at NIH and plays an essential role, enhancing trans-
NIH investments in longitudinal datasets, technology in support of
behavior change, innovative research methodologies, and promoting the
inclusion of behavioral science in initiatives in partnership with ICs.
OBSSR co-funds highly rated grants that the ICs cannot fund alone.
OBSSR is an integral component of many high-profile NIH programs and
initiatives:
--OBSSR has played a role in the fight against COVID-19, supporting
behavioral and social science research to address the pandemic
and disseminating best practices to encourage uptake of COVID-
19 vaccines. The Office, for example, has made over 50 awards
to study mitigation efforts, the long-term health and health
care effects of the resulting economic downturn, and potential
interventions to limit these effects.
--The Office also coordinates NIH's high-priority program on gun
violence prevention research, identifying effective public
health interventions to prevent firearm violence, and the
trauma, injuries, and mortality resulting from it.
--Additionally, OBSSR is central to the NIH UNITE initiative to end
structural racism and racial inequalities in health research. A
working group of the Behavioral and Social Sciences Research
Coordinating Committee is responsible for examining OBSSR-
funded research on racism and health to inform broader agency-
wide efforts to promote inclusion within NIH and in the
research it funds.
While the NIH budget has grown in recent years, funding for OBSSR
has not seen commensurate increases. We recognize that, located in the
Office of the Director, OBSSR does not have a specific appropriation.
Nonetheless, FABBS appreciates the opportunity to express support for
OBSSR and highlight that additional funding should enable the Office to
expand its work addressing the behavioral, social, and economic impacts
of the COVID-19 pandemic, measuring the effects of mitigation
strategies on vulnerable individuals and communities in preparation for
future pandemics, while maintaining its broad work in support of the
NIH mission.
institute of education sciences (ies), u.s. department of education
As members of the Friends of IES, FABBS encourages the subcommittee
to appropriate at least $700 million to IES in FY 2022. At this
critical juncture, a significant increase in IES funding is essential
to addressing learning loss caused by the COVID-19 pandemic and better
preparing American students for the future.
IES is a semi-independent, nonpartisan branch of the U.S.
Department of Education and is the research foundation for improving
and evaluating teaching and learning. The four centers-the National
Center for Education Statistics (NCES), National Center for Education
Research (NCER), National Center for Special Education Research (NCSER)
and National Center for Education Evaluation (NCEE)-work
collaboratively to efficiently and comprehensively produce and
disseminate rigorous research and high-quality data and statistics.
Already, the Institute has done important work to gauge the impact
of school closures on students, teachers, and school leaders, while
providing evidence-based guidance and technical assistance to inform
school reopening plans and support instruction in remote and hybrid
learning. IES launched Operation Reverse the Loss to identify specific
and actionable interventions that can reverse learning losses for
clearly identified populations of students.
Robust funding for IES in FY22 will allow the Institute to continue
its important work studying the effects of and developing strategies to
address learning loss due to COVID-19 and create a stronger educational
system.
Thank you for considering this request.
FABBS Member Societies:
Academy of Behavioral Medicine Research, American Educational
Research Association, American Psychological Association, American
Psychosomatic Society, Association for Applied Psychophysiology and
Biofeedback, Association for Behavior Analysis International, Behavior
Genetics Association, Cognitive Neuroscience Society, Cognitive Science
Society, International Congress of Infant Studies, International
Society for Developmental Psychobiology, Massachusetts
Neuropsychological Society, National Academy of Neuropsychology, The
Psychonomic Society, Society for Behavioral Neuroendocrinology, Society
for Computation in Psychology, Society for Judgement and Decision
Making, Society for Mathematical Psychology, Society for
Psychophysiological Research, Society for the Psychological Study of
Social Issues, Society for Research in Child Development, Society for
Research in Psychopathology, Society for the Scientific Study of
Reading, Society for Text & Discourse, Society of Experimental Social
Psychology, Society of Multivariate Experimental Psychology, Vision
Sciences Society
FABBS Affiliates:
APA Division 1: The Society for General Psychology; APA Division 3:
Experimental Psychology; APA Division 7: Developmental Psychology; APA
Division 28: Psychopharmacology and Substance Abuse; Arizona State
University; Binghamton University; Boston University; California State
University, Fullerton; Carnegie Mellon University; Columbia University;
Cornell University; Duke University; East Tennessee State University;
Florida International University; Florida State University; George
Mason University; George Washington University; Georgetown University;
Georgia Institute of Technology; Harvard University; Indiana University
Bloomington; Indiana University--Purdue University Indianapolis; Johns
Hopkins University; Kent State University; Lehigh University;
Massachusetts Institute of Technology; Michigan State University; New
York University; North Carolina State University; Northeastern
University; Northwestern University; The Ohio State University, Center
for Cognitive and Brain Sciences; Pennsylvania State University;
Princeton University; Purdue University; Rice University; Southern
Methodist University; Stanford University; Syracuse University; Temple
University; Texas A&M University; Tulane University; University of
Arizona; University of California, Berkeley; University of California,
Davis; University of California, Irvine; University of California, Los
Angeles; University of California, Riverside; University of California,
San Diego; University of Chicago; University of Colorado, Boulder;
University of Delaware; University of Houston; University of Illinois
at Urbana-Champaign; University of Iowa; University of Maryland,
College Park; University of Massachusetts Amherst; University of
Michigan; University of Minnesota; University of Minnesota, Institute
of Child Development; University of North Carolina at Greensboro;
University of Pennsylvania; University of Pittsburgh; University of
Texas at Austin; University of Texas at Dallas; University of
Washington; Vanderbilt University; Virginia Tech; Wake Forest
University; Washington University in St. Louis; Yale University
[This statement was submitted by Juliane Baron, Executive Director,
Federation of Associations in Behavioral and Brain Sciences.]
______
Prepared Statement of Florida A&M University
Chairman Leahy, Chair Murray, Vice Chairman Shelby, Ranking Member
Blunt, and Members of the Labor, Health and Human Services, and
Education, and Related Agencies Subcommittee, thank you for the
opportunity to submit public testimony on the subcommittee's Fiscal
Year (FY) 2022 appropriations bill. Florida A&M University (FAMU)
supports maintaining or enhancing funding for programs of interest to
the University and our students, including the Department of
Education's Historically Black Colleges and Universities (HBCU)
programs, the HBCU Capital Financing Program, and the federal Pell
Grants program. FAMU also supports two programs at the Department of
Health and Human Services--the National Institutes of Health's Research
Centers in Minority Institutions and the Health Resources and Services
Administration's Health Careers Opportunity Program. These federal
programs provide critical support to the University, our students as
well as other institutions of higher education and the nation.
Florida A&M University, based in the State capitol of Tallahassee,
Florida, was founded in 1887 with only 15 students and two instructors.
Today, FAMU has grown to nearly 10,000 students and we are proud to be
the highest ranked among public Historically Black Colleges and
Universities (HBCU) according to the U.S. News and World Report
National Public Universities. Our University offers 56 bachelor's
degrees, 29 master's degrees, 12 doctoral degrees and three
professional degrees. We are a leading land-grant research institution
with an increased focus on science, technology, research, engineering,
agriculture, and mathematics. As noted by Diverse Issues, FAMU is a top
producer of African American doctoral degrees in pharmacy and
pharmaceutical sciences.
Federal support is critical for institutions of higher education,
particularly HBCUs, which are historically under-resourced. Robust
federal funding for programs that help to improve our institutions,
broaden access for students, and improve student success is paramount.
The Department of Education HBCU programs help us achieve these goals
and the federal Pell Grant program is an imperative resource for our
students as the majority of our students are Pell-eligible.
Furthermore, the Department of Health and Human Services' research and
career development programs that support minority students also benefit
FAMU, our students, and the nation. FAMU strongly supports funding for
these vital federal programs.
department of education historically black colleges and universities
programs
FAMU strongly supports robust funding for the Department of
Education HBCU programs under the Higher Education, Aid for
Institutional Development Programs account. These programs, authorized
under Title III of the Higher Education Act, provide critical support
to higher education institutions that enroll large proportions of
minority and financially disadvantaged students. One of the primary
missions of the Title III programs has been to support the nation's
HBCUs. The Strengthening Historically Black Colleges and Universities
program and the Historically Black Graduate Institutions program
provide FAMU and other HBCUs with formula grants to help strengthen our
academic, administrative, and fiscal capabilities.
The President's FY 2022 budget requests $402.6 million for the
Strengthening Historically Black Colleges and Universities program.
These formula grants provide critical support to HBCUs that help to
improve our facilities, develop faculty, support academic programs,
strengthen institutional management, enhance our development and
recruitment activities, and provide tutoring and counseling services to
students. In FY 2019, FAMU received $7 million under the program.
We also support the President's FY 2022 budget request of $102.3
million for the Strengthening Historically Black Graduate Institutions,
which funds five-year grants to provide for scholarships for
disadvantaged students, academic and counseling services to improve
student success, and supports infrastructure and facilities
improvements. FAMU received $3.8 million under the current five-year
grant period for this program.
FAMU, like other HBCUs, has a critical need for funding to support
equipment upgrades and purchases, construction and renovation of our
facilities, and development of our academic programs. This includes a
wide variety of projects to strengthen the University and its programs,
such as expansion of our online education offerings to enhance pathways
to degree attainment, upgrading our information technology
infrastructure, construction of laboratories, research and education
facilities, and upgrading our health sciences and technology equipment
and facilities. Continued funding for these HBCU programs and other Aid
for Institutional Development programs is essential to postsecondary
institutions, like FAMU, that educate the nation's minority students.
department of education historically black colleges and universities
capital financing program
FAMU supports maintaining the FY 2021 enacted level of $48.848
million for the Department of Education's HBCU Capital Financing
Program, which provides low-cost capital to finance improvements to the
infrastructure of the nation's HBCUs. Specifically, the program
provides accredited HBCUs with access to capital financing or
refinancing for the repair, renovation, and construction of classrooms,
libraries, laboratories, dormitories, instructional equipment, and
research instrumentation.
FAMU, like other HBCUs, has a critical need to upgrade and
rehabilitate our aging facilities. This program makes capital available
for HBCUs to improve our academic facilities, which will enhance the
learning experience for our students. The requested funding would be
used to pay the loan subsidy costs in guaranteed loan authority under
the program. We urge the Subcommittee to maintain the current level of
funding for FY 2022, which will allow HBCUs to continue to refinance
previous capital project loans, renovate existing facilities, or build
new facilities to improve our institutions.
department of education pell grant program
FAMU supports robust funding for the Pell Grant program under the
Department of Education's Student Financial Assistance account. The
federal Pell Grant program, authorized by Title IV of the Higher
Education Act, is the largest source of federal grant aid supporting
college students. The Pell Grant Program provides need-based grants to
low-income undergraduate students to promote access to postsecondary
education.
For 2017-2018, there were 5,543 Pell Grant recipients attending
FAMU, amounting to $27.7 million in Pell Grant awards. Over 60% of our
enrolled students rely on Pell grants to attend our institution. Given
the ongoing coronavirus crisis, which will have devastating impacts on
the economy for the foreseeable future, we expect that our current and
prospective students will be dependent on financial assistance,
including Pell Grants, in order to continue pursuing their
postsecondary education goals.
The President's FY 2022 budget requests $25.475 billion for
Discretionary Pell Grants and proposes an increase in the maximum award
to $8,370 in academic year 2021-2022. FAMU would encourage Congress to
support the President's budget request substantially increasing the
total maximum Pell grant award in FY 2022 to provide critical support
for economically disadvantaged college students as we continue to
rebound from one of the most challenging periods in our nation's
history.
national institutes of health research centers in minority institutions
FAMU supports funding at the FY 2022 President's budget request of
$80 million for the NIH National Institute on Minority Health and
Health Disparities (NIMHD), Research Centers in Minority Institutions
(RCMI) Program. The RCMI Program, established in 1985, supports
critical infrastructure development and scientific discovery in
historically minority graduate and health professional schools. The
program serves the dual purpose of bringing more racial and ethnic
minority scientists into mainstream research and promoting minority
health research because many of the investigators at RCMI institutions
study diseases that disproportionately affect minority populations. The
RCMI Program develops and strengthens the research infrastructure
necessary to conduct state-of-the-art biomedical research and foster
the next generation of researchers from underrepresented populations.
Since program inception, the FAMU RCMI Center has received over $85
million from NIH, which has provided critical infrastructure to enable
the College to achieve national prominence and become a competitive
biomedical research center nationally. The RCMI support of FAMU led the
College to implement four doctoral tracks in pharmaceutical sciences,
including pharmacology/toxicology, medicinal chemistry, pharmaceutics,
and environmental toxicology. Moreover, as an outcome of the RCMI
support, our College of Pharmacy has graduated more than 60 percent of
the African American doctoral recipients in the pharmaceutical sciences
nationally.
department of health and human services, health resources and services
administration (hrsa), health careers opportunity program
FAMU supports the President's budget request of $15 million for
HRSA's Health Careers Opportunity Program (HCOP). First authorized in
1972, the HCOP competitive grant program aims to provide individuals
from disadvantaged backgrounds an opportunity to develop the skills
needed to successfully compete for, enter, and graduate from health or
allied health professions schools. HCOP focuses on three key milestones
of education: high school completion; acceptance, retention and
graduation from college; and acceptance, retention and completion of a
health professions degree program. The ultimate goal of the HCOP
program is to diversify the health professions workforce by narrowing
the educational achievement gaps between individuals from higher-income
and lower-income households.
The Health Careers Opportunity Program (HCOP) High School Summer
Institute, conducted on FAMU's campus, is designed for high school
students interested in pursuing a career in a health profession. The
four-week program provides a wide-range of educational and social
experiences for rising 10th, 11th and 12th grade students. The entire
experience is designed to enhance participants' academic abilities,
social skills, and other competencies to increase their competitiveness
for admission to a post-secondary health professions program.
The President's FY 2022 budget maintains funding for HRSA's Health
Workforce, Training for Diversity Programs, including the HCOP.
Continued funding is critical for these programs that help to increase
the supply of underrepresented minorities in health professions.
We urge the Subcommittee to support continued and/or enhanced
funding for these critical education programs at the Departments of
Education and Health and Human Services. We thank you for your
continued support of federal postsecondary initiatives that not only
directly benefit the University and our students, but the region and
the nation as well. Thank you for your consideration.
[This statement was submitted by Larry Robinson, Ph.D., President,
Florida A&M University.]
______
Prepared Statement of the Fred Hutchinson Cancer Research Center
The Fred Hutchinson Cancer Research Center (Fred Hutch) is grateful
to Congress for providing robust, reliable funding for the National
Institutes of Health (NIH), a key national priority. The nation's
investment in NIH research pays a lifetime of dividends in better
health and improved quality of life for all Americans. The impact of
the COVID-19 pandemic on the nation has demonstrated the importance of
a well-funded research enterprise. Thanks to decades of strong
congressional support for NIH, the scientific community was well-
equipped to rapidly respond to COVID-19. In fiscal year (FY) 2022, Fred
Hutch recommends at least $46.1 billion for the NIH. As the research
enterprise recovers from pandemic-related disruptions, now, more than
ever, it is essential to continue the trend of recent budget increases
to NIH to support lifesaving research.
Through strong, bipartisan leadership over the last six budget
cycles, the Appropriations Subcommittee on Labor, Health and Human
Services, Education and Related Agencies (Labor-HHS) has helped the NIH
regain lost ground after a period of effectively flat budgets. In the
FY 2021 omnibus bill, the Subcommittee's leadership continued this
trajectory by providing a substantial increase to all NIH institutes
and centers in addition to supplemental funding dedicated to COVID-19
research.
The federal investment in biomedical research has yielded a
significant number of scientific advances that improve health outcomes
for patients. Fred Hutch is committed to working with Labor-HHS,
Congress and the Administration to further bipartisan support for
increasing federal investment in biomedical science and ensuring NIH
remains a top priority in FY 2022. Because of NIH funding, Fred Hutch
can pursue fearless science and collaborations across its five
scientific divisions.
Founded in 1975, Fred Hutchinson Cancer Research Center is guided
by a mission to eliminate cancer and related diseases as causes of
human suffering and death. Fred Hutch's interdisciplinary teams of
world-renowned scientists and humanitarians work together to prevent,
diagnose, and treat cancer, HIV/AIDS and emerging infectious diseases.
Our Nobel Prize winning discoveries began in the 1970s with Dr. E.
Donnall Thomas' work in bone marrow transplantation, providing the
first definitive and reproducible example of the power of the human
immune system's ability to cure cancer. The leadership, depth and
breadth of Fred Hutch's transdisciplinary research makes the center one
of the National Cancer Institute's 51 designated Comprehensive Cancer
Centers, serving patients in five northwestern states.
In addition to groundbreaking discoveries in science, Fred Hutch is
investing in research to help narrow health inequities, implementing
initiatives that embrace diversity and inclusion in science and
empowering early career researchers. Below are some examples of how NIH
funding fuels Fred Hutch innovation and fosters future generations of
scientists:
--Responding to COVID-19. Researchers across Fred Hutch have moved at
lighting speed to test and develop potential therapies and
vaccines, increase and expand testing capacity, model the
course of the pandemic and emerging variants and study the
molecular interactions between SARS-CoV-2 and the human body.
Utilizing the expertise and clinical infrastructure of the HIV
Vaccine Trials Network (HVTN), headquartered at Fred Hutch, the
center also leads operations for the COVID-19 Prevention
Network (CoVPN), funded by the National Institute of Allergy
and Infectious Diseases, and co-leads the five large-scale
COVID-19 vaccine efficacy trials with over 200 clinical trial
sites in the U.S. and abroad.
--Mitigating Health Inequities. Fred Hutch understands the importance
of community engagement to overcome the pandemic and the HVTN's
community engagement experts have worked tirelessly for
inclusive and diverse participation in each of the CoVPN's
30,000 person vaccine trials. In just six months, the team
registered nearly 600,000 volunteers and has expanded
recruitment to volunteers for pediatric COVID-19 trials, long
COVID, and anticipated trials testing vaccines for variants.
Fred Hutch is also utilizing the decades-long work of its
public health scientists to disrupt the flood of misinformation
during the pandemic, so underrepresented communities receive
reliable, scientifically sound and understandable information
about COVID-19 and the vaccines.
--Embracing Diversity and Inclusion in Science. Fred Hutch recognizes
the importance of programs that promote diversity, equity and
inclusion. As the first U.S. Cancer Center to commit to the CEO
Action for Diversity & Inclusion plan and a member of the
Washington Employers for Racial Equity, Fred Hutch strives to
establish itself as a national exemplar in academia for its
Diversity, Equity and Inclusion (DEI) approaches and practices.
DEI is integrated as core values, principles and practices in
Fred Hutch's approach to research, its workforce development,
workplace culture and the communities Fred Hutch engages with.
The NIH's emphasis on DEI, including the Agency's DEI
initiative, UNITE and the FIRST faculty cohort program for
early career researchers are instrumental in ensuring the most
creative minds have the opportunity to contribute to the
nation's research and health goals. Congress' continued support
of the NIH funds vital efforts to increase representation and
promote varied perspectives throughout the entire biomedical
research enterprise.
--Empowering Early Career Researchers. Fred Hutch is inspiring the
next generation of researchers who will work at the frontiers
of life sciences. The center invests $2 million annually on
science education programs ranging from internship
opportunities for high school and college students, to
development resources and mentorship for graduate students,
postdoctoral fellows and early career faculty. The COVID-19
pandemic had an acute impact on these early career researchers,
and it revealed the need for a well-trained, motivated
scientific workforce. Ongoing investment in the NIH improves
the quality and cultural proficiency of science by increasing
access to scientific research and prepares young scientists to
become tomorrow's leaders.
The federal government has an irreplaceable role in supporting
biomedical research. No other public, corporate or charitable entity is
willing or able to provide the broad and sustained funding for cutting-
edge research that catalyzes innovative breakthroughs. The partnership
between NIH and America's research institutions and scientists is
highly productive.
As an independent research institute (IRI) with a mission to
eliminate cancer and related diseases, Fred Hutch depends on NIH
funding to conduct basic, translational, clinical, public health and
infectious disease research, and to respond quickly to the research
needs of the country. In addition to supporting robust funding, Fred
Hutch opposes provisions--such as directives to reduce salary support
for extramural researchers--which would harm the appeal of academic
research and disproportionately affect IRIs. Policies to cut salary
support undermine Fred Hutch's ability to recruit and retain the
talented researchers who keep U.S. institutions at the vanguard of
biomedical sciences.
Robust increases to the NIH budget do more than bolster important
research programs; it secures the future of science. Budget increases
enable initiatives that reduce barriers to academia, provides training
and education for young scientists starting independent careers and
encourages culturally inclusive research. Fred Hutch supports these
initiatives and principles and is applying them to its own workplace
and research pursuits.
Fred Hutch thanks the Labor-HHS Subcommittee for its leadership and
dedication to ensuring the health of the nation and your unwavering
support for NIH funding in FY 2022. We appreciate the opportunity to
urge the Subcommittee to provide at least $46.1 billion in FY 2022 for
NIH. Advances in bioscience, technology and data science have given the
life sciences tremendous momentum. This is not a time to pull back.
Given the abundance of scientific opportunity, this recommendation
represents a minimum investment to sustain progress that would be
amplified through an even more robust commitment.
[This statement was submitted by Thomas J. Lynch Jr., MD, President
and
Director, Fred Hutchinson Cancer Research Center.]
______
Prepared Statement of the Fred Hutchinson Cancer Research Center
Dear Senator Murray,
I am writing in support of the FY 2022 budget request for the
Department of Health and Human Services (DHHS) to develop a strategic
plan and national strategy for herpes simplex virus requested by Herpes
Cure Advocacy, an international patient-oriented nonprofit group
dedicated to alleviate the morbidity and mortality from herpes simplex
virus type-1 & type 2 (HSV-1 & HSV-2). While HSV as an infectious
disease is more than worthy of a public health research effort to
develop vaccines and curative therapies, recent work has suggested HSV
may also be a major player in Alzheimer's disease. Specifically, the
strategic plan and national strategy will request $2.5 billion from the
NIH and CDC over the next 3 years to address the immediate and critical
need for research into prevention, treatment and cure options to end
this silent pandemic of herpes simplex infections in our country.
I have been an advocate and investigator on herpesviruses for over
40 years, having founded the first patient advocacy group for genital
herpes (THE HELPER). Over 400 million new cases of genital herpes occur
each year. The disease is underappreciated due to its asymptomatic
spread, and in the normal host, HSV-2 mucosal ulcerations are normally
self-limited. However, systemic complications such as recurrent
meningitis, hepatitis, and pneumonitis occur during acquisition or
reactivation of infection, particularly among patients with poor T-cell
immunity due to AIDS, organ transplantation or chemotherapy. The major
complication of HSV worldwide is it increases the risk of HIV
acquisition 3-4 fold. The HIV prevention literature indicates that 40%
of HIV acquisitions are HSV-related; thus, 420,000 of the 1.2 million
new HIV cases yearly.
Recent epidemiological observations suggest many causes of
Alzheimer's disease are HSV-1-related. This is a plausible hypothesis
as HSV resides in the brain and the concept is that its presence
spreads the development of the protein plaques associated with
Alzheimer's. There are suggestions that treating HSV early may slow
progression of Alzheimer's. Better research is needed to define this
and see if novel therapies can be developed. The first antiviral drug--
acyclovir--invented by Dr. Gertrude Elion, one of the first women
scientists to receive a Nobel Prize, was developed in the early 1980s.
I was lucky enough to be a disciple of Dr. Elion and did the first
studies of the drug for genital herpes. It paved the way for HIV drugs,
yet it's 40 years later and we have the tools to make better drugs and,
more importantly, vaccines; vaccines to provide a cure and vaccines to
prevent HSV from being acquired. Imagine a vaccine that reduces HIV and
Alzheimer's disease. This is possible by preventing HSV infection.
One thing the COVID-19 pandemic has done is brought the injustice
and inequality of health care and resources for infectious diseases to
light in a way not previously advertised. We are at a crossroads now
with great levels of advocacy and the ability to make real change with
new technologies to tackle these silent epidemics.
Sincerely.
[This statement was submitted by Lawrence Corey, MD, Past President
and
Director, Fred Hutchinson Cancer Research Center.]
______
Prepared Statement of the Friends of the Health Resources and Services
Administration
The Friends of HRSA coalition is a nonpartisan coalition of nearly
170 national organizations representing tens of millions of public
health and health care professionals, academicians and consumers
invested in the Health Resources and Services Administration's mission
to improve health outcomes and achieve health equity. We are pleased to
submit our request of at least $9.2 billion for the Health Resources
and Services Administration in FY 2022. We are grateful for the
increases provided for HRSA programs in FY 2021 and for the emergency
supplemental funding to battle the COVID-19 pandemic, but HRSA's
discretionary budget authority is far too low to effectively address
the nation's current public health and health care needs. We urge
Congress to continue efforts to build upon these investments to
strengthen all of HRSA's programs.
HRSA's 90-plus programs and more than 3,000 grantees support tens
of millions of geographically isolated, economically or medically
vulnerable people, in every state and U.S. territory, to achieve
improved health outcomes by increasing access to quality health care
and services; fostering a health care workforce able to address current
and emerging needs; enhance population health and address health
disparities through community partnerships; and promote transparency
and accountability within the health care system. The agency is a
national leader in improving the health of Americans by addressing the
supply, distribution and diversity of health professionals and
supporting training in contemporary practices, and providing high-
quality health services to populations who may otherwise not have
access to health care.
HRSA programs work in coordination with each other to maximize
resources and leverage efficiencies. For example, Area Health Education
Centers, a health professions training program, was originally
authorized at the same time as the National Health Service Corps to
increase the number of primary care providers at health centers and
other direct providers of health care services for underserved areas
and populations. AHECs play an integral role to recruit providers into
primary health careers, diversify the workforce and develop a passion
for service to the underserved among future providers.
HRSA's programs also work in collaboration across the federal
government to enhance health outcomes. For example, HRSA's HIV/AIDS
Bureau partners with the Office of the Assistant Secretary for Health,
the Centers for Disease Control and Preventions, the Substance Abuse
and Mental Health Services Administration, the Centers for Medicare and
Medicaid Services, the Indian Health Services, the National Institutes
of Health, the Agency for Healthcare Research and Quality, the
Department of House and Urban Development, the Department of Veterans
Affairs and the Department of Justice to ensure an effective use of
resources, and a coordinated and focused public health response to the
HIV epidemic. This federal response has contributed to the number of
annual diagnosed HIV infections dropping 7 percent between 2014 and
2018, with HRSA's Ryan White HIV/AIDS Program serving as the foundation
for delivering health care and support services to reach the public
health goal of ending the HIV epidemic. Despite this success, an
estimated 1.2 million people in the U.S. are living with HIV today, and
approximately 36,400 become newly infected every year--1 in 7 of whom
are unaware of their infection. HRSA programs will play an integral
role in achieving the public health goal of ending the HIV epidemic.
HRSA grantees also play an active role in addressing emerging
health challenges. For example, HRSA's grantees provide outreach,
education, prevention, screening and treatment services for populations
affected by health emergencies such as the opioid epidemic. However,
much of this work required additional funding to increase capacity in
health centers, support National Health Service Corps providers to
deliver relevant care and expand rural health services. Strong,
sustained funding would allow HRSA to quickly and effectively respond
to emerging and unanticipated future health needs across the U.S.,
while continuing to address persistent health challenges.
HRSA programs and grantees are providing innovative and successful
solutions to some of the nation's greatest health care challenges
including the rise in maternal mortality, the severe shortage of health
professionals, the high cost of health care, and behavioral health
issues related to substance use disorder--including opioid misuse. We
recommend Congress build upon the important increases they provided for
HRSA programs in FY 2021 and provide at least $9.2 billion for HRSA's
total discretionary budget authority in FY 2022. Additional funding
will allow HRSA to pave the way for new achievements and continue
supporting critical HRSA programs, including:
--Primary care programs support nearly 13,000 health center sites in
every state and territory, improving access to preventive and
primary care for nearly 30 million people in geographic areas
with few health care providers. Health centers coordinate a
full spectrum of health services including medical, dental,
vision, behavioral and social services in the nation's most
underserved communities. Health centers reach 1 in 3 people
living at or below the federal poverty line; 1 in 5 rural
residents; 1 in 4 uninsured persons; and 1 in 8 children.
--Health workforce programs at HRSA support the entire training
continuum by strengthening the workforce and connecting skilled
professionals to communities in need. Programs such as the
Public Health Training Centers assess and respond to critical
workforce needs through training, technical assistance and
student support.
--Maternal and child health programs, including the Title V Maternal
and Child Health Block Grant, Healthy Start and others, support
initiatives designed to promote optimal health, reduce
disparities, combat infant and maternal mortality, prevent
chronic conditions and improve access to quality health care
for mothers and babies. MCH programs help assure that nearly
all babies born in the U.S. are screened for a range of serious
genetic or metabolic diseases, and that coordinated long-term
follow-up is available for babies with a positive screen. They
also help improve early identification and coordination of care
for children with sensory disorders, autism and other
developmental disabilities. The MCH Block Grants funded 59
states and jurisdictions to provide health care and public
health services for an estimated 60 million people, reaching
92% of pregnant women, 98% of infants, and 60% of children
nationwide.
--HIV/AIDS programs provide the largest source of federal
discretionary funding assistance to states and communities most
severely affected by HIV/AIDS. The Ryan White HIV/AIDS Program
delivers comprehensive care, prescription drug assistance, and
support services to more than 519,000 people impacted by HIV/
AIDS. HRSA's Ryan White HIV/AIDS Program effectively engages
clients in comprehensive care and treatment, including
increasing access to HIV medication, which has resulted in
88.1% of clients achieving viral suppression, compared to just
64.7% of all people living with HIV nationwide. Additionally,
the program provides education and training for health
professionals treating people with HIV/AIDS, and works toward
addressing the disproportionate impact of HIV/AIDS on
communities of color.
--Title X ensures access to a broad range of reproductive, sexual and
related preventive health services for over 3.1 million women,
men and adolescents, with priority given to low-income
individuals. Services include patient education and counseling
for family planning; provision of contraceptive methods;
cervical and breast cancer screenings; sexually transmitted
disease prevention education, testing and referral; and
pregnancy diagnosis. This program helps improve maternal and
child health outcomes and promotes healthy families.
--Rural health programs improve access to care for people living in
rural areas. The Office of Rural Health Policy serves as the
nation's primary advisor on rural policy issues, conducts and
oversees research on rural health issues and administers grants
to support health care delivery in rural communities. Rural
health programs support community-based disease prevention and
health promotion projects and expand health information
technology and telehealth.
--Special programs include the Organ Procurement and Transplantation
Network, the National Marrow Donor Program, the C.W. Bill Young
Cell Transplantation Program and National Cord Blood Inventory.
These programs facilitate organ marrow and cord blood donation,
support transplantation and research and increase organ
donation rates. The Poison Control Program oversees poison
control centers which contribute to decreasing a patient's
length of stay in a hospital and save the government $1.8
billion each year in medical costs and lost productivity.
--HRSA is well positioned to respond to infectious disease outbreaks
and has been active in the COVID-19 pandemic response, awarding
billions of dollars to health centers to administer COVID-19
tests and reimbursing providers who offer COVID-19 care to
uninsured individuals.
To meet the many ongoing public health challenges facing the
nation, including those outlined above, we urge you to support at least
$9.2 billion for HRSA's programs in FY 2022.
[This statement was submitted by Jordan Wolfe, Manager of
Government
Relations, American Public Health Association.]
______
Prepared Statement of the Friends of the Institute of Education
Sciences
Chair Murray, Ranking Member Blunt, and Members of the
Subcommittee, thank you for the opportunity to submit written testimony
on behalf of the Friends of IES, a consortium of scientific and
professional societies, research universities, and independent research
organizations committed to supporting the mission of IES and the use of
research and statistics. We recommend $737.47 million for the Institute
of Education Sciences (IES) in the FY 2022 Labor, Health and Human
Services, and Education Appropriations bill. This request is aligned
with the top line amount included for IES in the president's budget
request.
IES is the independent and nonpartisan statistics, research, and
evaluation arm of the U.S. Department of Education charged with
supporting and disseminating rigorous scientific evidence on which to
ground education policy and practice. As such, it serves as the
critical federal source for funding groundbreaking research in myriad
aspects of teaching and learning, as well as rigorous analysis of
educational programs and initiatives. Throughout the pandemic, IES has
sought to meet the demand for evidence-based resources to help
facilitate remote instruction, address academic and socioemotional
needs of students, and support teachers and school leaders in adapting
to the ever-changing conditions resulting from the pandemic.
Its four centers-the National Center for Education Statistics
(NCES), National Center for Education Research (NCER), National Center
for Special Education Research (NCSER), and National Center for
Education Evaluation (NCEE)-work collaboratively to efficiently and
comprehensively deliver rigorous research and high-quality data and
statistics to educators, parents, and policymakers.
Our member organizations rely on IES to support vital research that
addresses many of the most important issues in our nation's schools. We
are deeply thankful for the increases provided to IES in recent years
to further invest in the education research and statistical
infrastructure and to respond to the impact of COVID-19 on our most
marginalized populations.
At the same time, IES remains constrained in its flexibility to
fully fund emerging research areas and scale up promising interventions
and resources. Only one of every ten grant proposals receives funding
support, limiting the ability of IES to tackle pressing questions in
education, such as what can be done to support student learning in
informal settings, address challenges facing rural districts, and
improve literacy for adult learners. Additional investment in Research,
Development, and Dissemination could support new high-risk, high-reward
research with the potential for transforming education, along with
funding research in foundational and emerging areas in education and
supporting the synthesis of research findings for use by all education
stakeholders.
The National Center for Education Statistics (NCES) is the primary
federal entity dedicated to collecting data related to education and is
the only principal statistical agency dedicated to this mission. NCES
compiles and disseminates important, trustworthy, and scientifically
valid data on the condition of education that is essential to policy,
practice, and research being conducted across the nation. Most
recently, NCES' pivoting and partnering with the Census Bureau and four
other federal statistical agencies to get weekly estimates of the
impact of COVID-19 is just one palpable example of its vital role.
Sufficient funding for NCES can enhance the ability of NCES to develop
and administer surveys, analyze data on timely education issues, and
link administrative education data to health and employment data for
evidence-based policymaking and to understand the broader context of
outcomes.
NCES importantly provides the funding support and infrastructure
for the Statewide Longitudinal Data Systems (SLDS), providing critical
investment for states to link K-12, postsecondary, and workforce
systems to gain a better understanding of education and workforce
outcomes. IES is also promoting the research use of SLDS to measure the
effects of interventions on long-term student outcomes. Additional
resources for SLDS can support states in linking data across education
and workforce systems.
In addition to the research supported by the National Center for
Education Research, the Regional Educational Laboratories (RELs)
conduct applied research that is directly relevant to state and
district administrators, principals and teachers. RELs also ensure that
research is shared widely through its deep dissemination networks.
During the pandemic, the RELs have provided a wide range of evidence-
based resources to guide teachers, school leaders, and state and local
officials on COVID-19 response. This work is all driven by the state
education agencies and other stakeholders in the regions. Additional
funding is needed to research and support growing local and regional
needs to respond to the impact of the pandemic on academic, social and
emotional learning.
The National Center for Special Education Research (NCSER) is the
only federal agency specifically designated to develop and provide
evaluations for programs for students with disabilities. Research
funded by NCSER has resulted in programs such as those that support
youth with high functioning autism experiencing high levels of anxiety,
individuals with Down syndrome learning to read, and students with
learning disabilities studying to master math word problems. NCSER also
provides special educators and administrators research-based resources
that support the provision of a free appropriate public education and
interventions to foster self-determination in students with
disabilities as they transition into adulthood. COVID-19 has had a
disproportionate impact on students with or at-risk of disabilities who
have faced significant barriers to educational access over the past
year. Although funding from the American Rescue Plan will support such
research in an FY 2022 grant competition, NCSER will not hold a
competition for non-pandemic-related research due to limited funding.
With additional funding, NCSER could support data and evidence-based
resources to guide teachers, administrators, and policymakers in state
and local agencies.
Alongside the recommendation regarding the investment in IES, we
encourage you to include language in the Program Administration line to
allow for IES to hire additional staff. Understanding that the
Department of Education approves hiring authority, IES can be more
innovative and flexible in carrying out its mission and support
emerging areas of research and statistical collection with additional
staff. As one example, NCES staff have technical expertise but are also
responsible for managing contracts for its surveys. Providing authority
for NCES to hire more staff can allow the agency to fully discharge its
responsibilities, including the integration of new forms of massive and
fast data. To execute these functions effectively requires staff of
adequate size.
To this end, we recommend that the Committee provide IES $737
million in FY 2022. As our country emerges from a year of the greatest
national disruption our schools have ever seen, it is clear that there
is a demand for evidence-based resources for our teachers, school
leaders, students, and families to support learning and instruction. A
commitment at this level will enable IES to more fully support research
that addresses the challenges of preparing young Americans to succeed
in the knowledge-based economy that is not only upon us now, but also
the key to future American prosperity.
[This statement was submitted by Felice J. Levine, Chair, Friends
of the Institute of Education Sciences.]
______
Prepared Statement of the Friends of the National Institute of Child
Health and Human Development
I write on behalf of the Friends of NICHD, a coalition of more than
100 organizations representing patients, providers, scientists, and
caregivers who are united in our support for ensuring the health and
welfare of women, children, families, and people with disabilities
through research funded by the Eunice Kennedy Shriver National
Institute of Child Health and Human Development (NICHD) and the
National Institutes of Health (NIH). We urge the subcommittee to
provide NICHD with no less than $1.7 billion in Fiscal Year (FY) 2022,
an increase of $117 million over FY 2021. We also respectfully ask the
subcommittee to maintain its commitment to increasing funding for the
National Institutes of Health (NIH) by providing no less than $46.1
billion in FY 2022.
We are pleased to support the extraordinary achievements of NICHD
in meeting the objectives of its biomedical, social, and behavioral
research mission, including research on child development before and
after birth; women's health throughout the life cycle; maternal, child,
and family health; learning and language development; reproductive
biology; population health; and medical rehabilitation. With these
necessary resources, NICHD can ensure proportional growth to that of
its counterpart institutes and build upon the initiatives we've listed
below to provide new insights and solutions to benefit women, children,
and families in your districts and states.
COVID-19: NICHD has played a key role in understanding the impact
of the COVID-19 pandemic on the institute's populations, including
pregnant and postpartum women, children and adolescents, people with
intellectual and developmental disabilities, and people with physical
disabilities and mobility impairments. This work includes intramural
research studies, collaborations with other NIH institutes and centers,
and major undertakings like the Gestational Research Assessments for
COVID-19 (GRAVID) study and the Predicting Viral-Associated
Inflammatory Disease Severity in Children with Laboratory Diagnostics
and Artificial Intelligence (PreVAIL kIds) which are advancing our
knowledge of understudied COVID-19 research questions. NICHD also
continues to advocate for inclusion of its key populations in major
trans-NIH programs like the Rapid Acceleration of Diagnostics (RADx)
initiative.
Maternal Mortality: The Pregnancy and Perinatology Branch, through
networks including the Maternal-Fetal Medicine Units (MFMU) Network,
supports research to improve the health of women before, during and
after pregnancy. Maternal mortality rates are at an unprecedented high
in the United States and significant racial and ethnic disparities
persist. Research to better understand the mechanisms of disparities,
to include social determinants of health and genetic factors that
adversely affect pregnancy outcomes, are vitally needed.
Data on Pediatric Enrollment in NIH Trials: NIH requires
investigators to submit deidentified demographic data on study
participants, including age at enrollment. It is important for NIH to
analyze and publicly report on this data to ensure that all
populations, including children, benefit from research. This data
should be used proactively NIH-wide to address recruitment issues in
ongoing studies in real time and to drive forward the inclusion of
individuals across the lifespan, including children. NICHD should play
a leading role in the implementation of this policy vis-a-vis age.
Infant and Childhood Health: Through the Best Pharmaceuticals for
Children Act (BPCA), NICHD funds the study of old, off-patent drugs
important to children but inadequately studied in pediatric
populations. We urge continued funding for this research and for
training the next generation of pediatric clinical investigators. We
also strongly support NICHD's ongoing research into the causes and
prevention strategies for the major causes of death in infancy and
childhood, including sudden unexpected infant death, accidents, and
suicide.
Behavioral Health Research: NICHD supports a range of research on
child development and behavior and has made great progress developing
sophisticated tools to measure children's cognitive, emotional, and
social functioning. To build on these successes, we encourage more
integrated behavioral and biobehavioral work on child developmental
trajectories, across infancy, childhood, and adolescence, in both
normative and at-risk environments, across diverse contexts (school,
home, and community) and including underrepresented and vulnerable
groups. More research is also needed on integrated behavioral health in
primary care settings, including cost effectiveness comparisons, and
the impact of behavioral interventions on mental health, physical
health, and quality of life. Child health would also benefit from
additional work on the role of technology to support optimal
development in children, including those with disabilities, and
increased access to and engagement with effective psychological and
behavioral interventions for childhood conditions.
Poverty and Child Health: Poverty can be especially detrimental in
childhood and adolescence, leading to adverse impacts on physical
health, mental health, social well-being, cognitive and emotional
development, and the acquisition of motor and language skills. NICHD is
in the unique position to examine the biological, psychological,
social, cultural, and environmental factors that impact the developing
child in high-poverty environments--including challenges due to chronic
stress, neighborhood safety, school environments, family health status,
education, job instability, unstable family structures, and substandard
living conditions--and to evaluate interventions aimed at improving the
developmental trajectories of these children.
Reproductive Sciences: Research on the basic biological mechanisms
of reproduction is a crucial foundation for all NICHD's work.
Understanding reproductive biology and associated biological phenomena
provides the foundation for innovative medical therapies and
technologies and improves existing treatment options for gynecologic
conditions. Often, this research focuses on serious conditions that are
overlooked and underfunded, even though they impact many women. Future
work could address infertility and the need for treatments for
endometriosis, polycystic ovarian syndrome (PCOS) and uterine fibroids.
Pelvic Floor Disorders Network (PFDN): Female pelvic floor
disorders represent a major public health burden with high prevalence,
impaired quality of life and substantial economic costs affecting 25%
of American women. The PFDN conducts research to improve treatment of
these painful gynecological conditions. Current research aims to
improve female urinary incontinence outcome measures and ensure high-
quality outcomes.
PregSource: NICHD's PregSource\TM\ Initiative enables pregnant
women to track their health data from gestation to early infancy and
access evidence-based information about healthy pregnancies. It will
also allow researchers to utilize aggregated data and potentially
recruit participants for clinical trials so that knowledge gaps can be
eliminated and care for pregnant and post-partum women can be improved.
Task Force Specific to Research in Pregnant Women and Lactating
Women (PRGLAC): We urge Congress to continue its strong support of the
NICHD-led PRGLAC Task Force, and to support the recommendations
contained in the report to achieve broader inclusion of pregnant and
lactating women in research and expansion of the workforce of
clinicians and researchers with expertise in obstetric and lactation
pharmacology and therapeutics, so that lifesaving treatments for this
population are known to be safe and effective.
NIH Pediatric Research Consortium (N-PeRC): N-PeRC is an NICHD-led,
trans-NIH initiative that aims to harmonize pediatric research and
training activities across the NIH. N-PeRC capitalizes on pediatric
expertise at the NIH by enabling collaboration to explore gaps in the
overall pediatric research portfolio and share best practices to
advance science. N-PeRC has played a vital role throughout the COVID-19
pandemic in identifying key child and adolescent research needs related
to SARS-CoV-2.
Human Development, Infancy Through Adulthood: NICHD supports
research on infant-through-adult development, including how father-
child relationships and co-parenting positively impacts children's
socio-emotional development and decreases behavior problems; children's
adjustment after the birth of a sibling; pathways and outcomes
associated with mothers' postseparation co-parenting relationships,
with a particular focus on experiences of intimate partner violence and
negative outcomes; and the health and well-being across three
generations of lesbians, gay men, and bisexuals.
Intellectual and Developmental Disabilities Research Centers
(IDDRC): The IDDRCs are a critical national resource for basic research
into the genetic and biological basis of human brain development,
greatly improving our understanding of the causes of developmental
disabilities and contributing to the development and implementation of
evidence-based practices by evaluating the effectiveness of biological,
biochemical, and behavioral interventions. These centers have
contributed to new treatments for genetic disorders through the study
of intellectual and developmental disabilities, such as Everolimus for
epilepsy in TSC. We must build on progress in the understanding and
treating this class of disorders that affect so many. We urge resources
and support for the IDDRCs for research infrastructure and expansion to
conduct basic and translational research to develop effective
prevention, treatment and intervention strategies for children and
adults with developmental disabilities.
Preterm Birth: NICHD supports a comprehensive research program on
the causes, prevention and treatment of preterm birth, the leading
cause of infant mortality and intellectual and physical disabilities.
Research shows the survival rate and neurological outcomes may be
improving for very early preterm infants, but continued prioritization
is needed through extramural preterm birth prevention research, the
MFMU Network, the Neonatal Research Network, and intramural research
program. Robust funding is needed for research to determine the complex
interaction of behavioral, social, environmental, genetic, and
biological influences on preterm birth with the goal of developing the
interventions necessary to decrease prematurity.
Population Dynamics: The NICHD Population Dynamics Branch supports
research on how population change affects the health, development, and
well-being of children and their families. Longitudinal surveys, such
as the Fragile Families and Child Wellbeing Study, have demonstrated
the role that family stability and parental involvement play in the
long-term health and development of children, facilitating tremendous
progress in the population sciences. NICHD also supports the Population
Dynamics Centers Research Infrastructure Program, which supports
research and research training in demographic or population research.
These centers focus on research such as family demography and
intergenerational relationships; education, work, and inequality;
population health; and reproductive health.
Male Infertility: Male infertility is another relevant area of
inquiry that would benefit from NICHD-sponsored research. For instance,
the biological mechanisms associated with common causes of male
infertility, such as varicoceles, remain poorly understood. These
research domains represent important opportunities to develop better
treatments for male infertility.
[This statement was submitted by KJ Hertz, 2021 Chair, Friends of
the National Institute of Child Health and Human Development.]
______
Prepared Statement of the Friends of the National Institute of Diabetes
and Digestive and Kidney Diseases
On behalf of the 35 patient, physician, and research organizations
that are members of the Friends of the National Institute of Diabetes
and Digestive and Kidney Diseases (NIDDK), we want first to thank you
for your ongoing bipartisan investment in the National Institutes of
Health (NIH). We ask you to support our FY 2022 NIH funding
recommendation of at least $46.111 billion, a $3.177 billion increase
over the comparable FY 2021 funding level for the NIH, which would
allow for the NIH's base budget to keep pace with the biomedical
research and development price index of 2.3% and allow meaningful
growth of 5%. We also request a proportionate increase for the NIDDK of
at least $157 million for a total of $2.289 billion in FY 2022. This
level of increase over its FY 2021 funding is necessary for NIDDK to
fulfill its mission to conduct and support medical research, research
training, and to disseminate science-based information on diabetes and
other endocrine and metabolic diseases; digestive diseases, nutritional
disorders, and obesity; and kidney, urologic, and hematologic diseases
and to support the Institute's multi-pronged efforts toward the goal of
health equity. We also strongly encourage you to provide supplemental
emergency funding of $10 billion for NIH, ensure dedicated support for
the NIDDK to enable critical COVID-related research, and support
research recovery from the impact of the pandemic.
NIDDK supports and conducts research to combat a portfolio of
diseases that encompass some of the most chronic, common,
consequential, and costly diseases and conditions affecting people in
this country. Many of these diseases and disorders are also associated
with health disparities. These disparities are exacerbated by the
COVID-19 pandemic, with increased rates of infection and poor outcomes
from COVID-19 seen in people with these same conditions.
We want to share just a few NIDDK-supported research highlights to
demonstrate the great impact and promise of NIDDK research to improve
people's health and quality of life (more thorough descriptions are in
NIDDK's Recent Advances & Emerging Opportunities):
--Research on an immune-targeting drug has delayed type 1 diabetes
progression in high-risk individuals for at least 3 years. This
is the first time ever that early preventive therapy was found
to delay onset of clinical type 1 diabetes.
--Research defining subgroups of people with chronic kidney disease
is paving the way for kidney precision medicine.
--Adult and pediatric studies are testing potential therapies and
uncovering genetic and racial/ethnic risk factors for
nonalcoholic fatty liver disease and nonalcoholic
steatohepatitis.
--The Intestinal Stem Cell Consortium is studying intestinal stem
cells' roles in intestinal health and disease, aiming to
identify and develop novel therapies to regenerate the human
intestine.
--The NIDDK sponsored Symptoms of Lower Urinary Tract Dysfunction
Research Network (LURN) is working to improve the lives of
patients affected by lower urinary tract dysfunction (LUTD)
through overcoming barriers to diagnosis and treatment.
--Innovative research by NIDDK scientists showed the potential
importance of speech-generated droplets in SARS-CoV-2
transmission.
--NIDDK research has led to better treatments such as new drugs that
can dramatically reduce disease burden for many with cystic
fibrosis; increased understanding and treatment of inflammatory
bowel diseases such as Crohn's disease and ulcerative colitis;
and to new Type 2 diabetes drugs that provide cardiovascular
health benefits in people with diabetes.
Our organizations are grateful for the funding that you have
provided to the NIH and the NIDDK as part of the appropriations process
and the support Congress has given to the NIH, including several of its
institutes and centers, to respond to the public health emergency.
However, we note that NIDDK's FY 2021 appropriation was proportionally
less than other Institutes and NIDDK and has not received any emergency
funding despite researching diseases that are associated with increased
risk of severe COVID-19 outcomes and are themselves public health
crises.
As health professionals and researchers continue to respond to this
pandemic, our understanding of COVID-19 continues to evolve. What we
originally understood to be an infectious, respiratory virus, we now
know disproportionately impacts individuals with diabetes, obesity,
liver diseases and kidney diseases. COVID-19 infection damages a
variety of organ systems, including the kidneys and it may even
contribute to new onset of kidney failure and diabetes. Patients also
are experiencing hematologic complications, including issues related to
coagulation and blood cell production. Yet, without additional funding,
NIDDK will be forced to continue to divert crucial funds from its
existing priorities to better understand these characteristics of
COVID-19, a loss to the patients who ultimately benefit from research
funded by NIDDK.
With emergency supplemental funding, NIDDK will be able to support
research on SARS-CoV-2/COVID-19 as it intersects with and affects
people with or at risk for diabetes and other metabolic diseases,
obesity, and endocrine, digestive, hepatobiliary, pancreas, kidney,
urological and hematologic diseases. Specific areas of research
include: determining the basis for the link between COVID-19 severity
and diseases in the NIDDK's portfolio; identifying novel pathogenic
pathways and potential translational targets for the treatment or
prevention of kidney, gastrointestinal, and endocrine/metabolic
diseases associated with SARS-CoV-2 infection; and understanding the
roles of health disparities associated with SARS-CoV-2 infection, organ
injury, and adverse disease outcomes.
Further, the occurrence of Post-Acute Sequelae of SARS-CoV-2
infection (PASC), in which individuals experience persistent symptoms
involving multiple body systems after recovering from their initial
illness, shows that while new infections with SARS-CoV-2 have decreased
in the US, our understanding of the long-term consequences of COVID-19
is far from over and creates another important and emerging research
opportunity.
In addition to new areas of research, the pandemic has created
additional barriers and expenses that complicate restarting research.
Supplemental funds are needed to:
--Restart research projects, programs, and clinical trials that were
underway before the onset of the pandemic and were stopped or
delayed for safety reasons, consequently stalling or delaying
new discoveries.
--Support early-stage investigators as they face uncertainties and
challenges in making progress in their careers, especially
women investigators and others who are disproportionately
affected by caregiving roles during the pandemic and members of
groups underrepresented in research.
--Provide financial support so that critical research support staff
can be retained and to accelerate the eventual resumption of
research activities post-pandemic.
--Address increasing research costs. The burden of restarting
clinical trials, animal colonies, and other programs and
resources has made conducting research more challenging and
expensive during the pandemic. Costs for personal protective
equipment (PPE), comprehensive cleaning, and ``time sharing''
in laboratories are a few examples.
All of this leads to a simply put yet challenging goal: While
addressing the immediate challenges of COVID-19, we also need to
continue to combat the diseases within NIDDK's mission, which will
continue to place an enormous personal and financial toll on this
country long after the pandemic is over. Bolstering support for NIDDK
will help ensure that critical research in these areas continues and
will support the institute's commitment to understanding the roles of
social determinants of health and health disparities with the goal of
improving health for all. Our nation's progress against COVID-19--and
every other health threat--is built on the longstanding bipartisan
commitment to medical research. Preserving that investment will be key
to continued advances. We urge you to support the NIH with a $3.1
billion increase for FY 2022 with a proportionate increase of $157
million for NIDDK and provide emergency supplemental funds for NIH,
including dedicated support for the NIDDK, to ensure we lead the world
in providing new and better cures, diagnostics, and treatments while
protecting all patients and the research enterprise.
______
Prepared Statement of the Friends of the National Institute of
Mental Health
Chair Murray, Ranking Member Blunt, and Members of the
Subcommittee:
I write on behalf of the Friends of NIMH, a newly formed coalition
of more than 30 organizations representing scientists, physicians,
health care providers, individuals, families, and communities. The
members of the Friends of NIMH are dedicated to supporting the mission
of the National Institute of Mental Health (NIMH) to transform the
understanding of mental health and the treatment of mental illnesses
through basic biomedical, behavioral, and clinical research, to best
inform prevention, early intervention, recovery, and cures. We write to
encourage you to provide robust funding for NIMH in FY 2022 so that the
institute can build upon the significant achievements to advance the
behavioral, biomedical, and social research mission and important
initiatives to provide new insights and solutions to benefit your
constituents. Our member organizations represent communities with
interest across the National Institutes of Health (NIH). Individually
and collectively, our members also belong to the Ad Hoc Group for
Medical Research, a coalition of over 330 patient and voluntary health
groups, medical and scientific societies, academic and research
organizations, and industry that support enhancing the federal
investment in the behavioral and biomedical research conducted and
supported by the NIH. Aligned with the Ad Hoc request, we respectfully
request that the subcommittee provide at least $46.1 billion for the
agency in Fiscal Year (FY) 2022, $3.2 billion above the final FY21
funding level.
Thank you for considering this request.
______
Prepared Statement of the Friends of the National Institute on Aging
On behalf of the Friends of the National Institute on Aging
(FoNIA), we are grateful for your leadership in advancing the mission
of National Institutes of Health (NIH), and the research supported and
conducted by the National Institute on Aging (NIA). FoNIA is a
coalition of more than 50 academic, patient-centered and non-profit
organizations supporting NIA's mission to understand the nature of
aging and the aging process, and diseases and conditions associated
with growing older in order to extend the healthy, active years of
life.
We are writing to request that federal resources continue to be
dedicated to sustaining and enhancing timely and promising aging
research at NIA and across NIH.
Specifically, FoNIA requests:
--No less than $46.1 billion--a $3.3 billion increase--in fiscal year
(FY) 2022 for total spending at NIH for current institutes and
operations, including funds from the 21st Century Cures Act for
targeted initiatives which corresponds with the overall
recommendation of the Ad Hoc Group for Medical Research.
--An increase of least $500 million specifically dedicated to support
cross-Institute aging research at the NIH, including but not
limited to biomedical, behavioral and social sciences aging
research. This increase must be separate from whatever funds
are allocated to the Advanced Research Projects Agency for
Health (ARPA-H) at NIH. Investment in ARPA-H should not come at
the cost of the existing NIH institutes and centers conducting
and supporting research on aging.
--A minimum increase of $289 million specific to research on
Alzheimer's disease and related dementias (ADRD). NIA is the
primary federal agency supporting and conducting Alzheimer's
disease and related dementias research.
FoNIA understands that during this time, Congress is working hard
to stem fallout of both the human and fiscal toll of COVID. In this
rapidly evolving crisis, NIH/NIA has played an extremely vital role in
examining how COVID impacts older adults, why they may be more
susceptible to the virus, how they can be protected, and the social and
economic effects of the pandemic on older adults.
NIA sponsors and conducts the lion's share of federal aging-related
research, and this pioneering science contributes significantly to the
improved care and quality of life of older adults. A key NIA priority
is translating research into better and more efficient care through the
development of effective interventions that are disseminated to health
care providers, patients, and caregivers. These interventions for the
prevention, early detection, diagnosis, and treatment of disease will
help reduce the burden of illness for older adults and reduce the cost
of care.
NIA's COVID response has been wide and varied. NIA has been heavily
involved in the work of the Rapid Acceleration of Diagnosis (RADx)
program designed to speed innovation in the development,
commercialization, and implementation of technologies for COVID
testing. NIA is especially active in the RADx Underserved Populations
(RADx-UP) program, which strives to understand the factors associated
with disparities in COVID morbidity and mortality.
In the area of dementia, NIA supports vital research where more
scientific investigation is needed to improve AD/ADRD prevention,
diagnosis, treatment and care; basic science approaches to illuminate
neurodegenerative mechanisms/pathways; and computational/biological
systems approaches to identify, model and predict the architecture and
dynamics of the molecular interactions underlying AD/ADRD pathogenesis.
NIH's Brain Research through Advancing Innovative Technologies
(BRAIN) Initiative works to develop a dynamic picture of how neurons
act, both individually and together in circuits. The initiative
revolutionizes our understanding of the human brain and provides
insight into how to treat, prevent and cure brain disorders. In
addition to NIH, this public-private partnership involves other federal
agencies such as the National Science Foundation (NSF), Defense
Advanced Research Projects Agency (DARPA), Intelligence Advanced
Research Projects Activity (IARPA), the Food and Drug Administration
(FDA) and the Department of Energy (DOE).
Lastly, NIH funding provides a vital economic boost to local
economies. Most of NIH/NIA funding is distributed as grants to
universities and other research institutions across the US, and acts as
an economic engine and multiplier in local and regional communities.
According to United for Medical Research, total FY 2020 NIH research
spending of $34.65 billion supported more than 536,338 American jobs
and generated nearly $91.35 billion in economic activity across the
country.
Thanks to your support, NIH/NIA is continuing to accelerate
scientific discoveries which will benefit us all as we age. Only
through continued, and meaningful investments in NIH/NIA will it be
possible to enhance the quality of care for older adults across the
nation.
Thank you for your consideration of this funding request. Should
you need additional information, feel free to contact me at
[email protected].
Sincerely.
[This statement was submitted by Eric W. Sokol, Chair, Friends of
the National Institute on Aging.]
______
Prepared Statement of the Friends of the National Institute on
Drug Abuse
Thank you for the opportunity to submit testimony in support of the
National Institute on Drug Abuse (NIDA). The Friends of the National
Institute on Drug Abuse is a coalition working with about 150 scholarly
organizations with a total membership of at least 2 million scholars,
clinicians and educators who are committed to eliminating substance use
disorders in society. We coordinate the opinions of the participating
organizations, who also actively participate on their own to provide
important information to policy makers to make decisions that will lead
to the elimination of this disease which now is killing so many of our
citizens. For example, former research which led to the creation of
drugs such as naloxone and buprenorphine has provided important
mechanisms which have prevented the death rate from being even much
higher. We need more research in all areas of basic and clinical
science to make additional advances.
In the Fiscal Year 2022 Labor, Health and Human Services
Appropriations bill we request that the subcommittee include the
President's requested level of $51 billion for the National Institutes
of Health (NIH), including no less than $46.1 billion for NIH's base
program level budget. In addition, we greatly appreciate the President
Budget's recognition of the need to significantly increase our nation's
investment in the National Institute on Drug Abuse (NIDA) and its
response to the opioid epidemic. The President's Fiscal 2022 Budget
recommends a $372.2 million increase in NIDA's budget, a 25 percent
increase. We strongly encourage the Subcommittee to include the
President's recommended funding level of $1.852 billion for NIDA in the
Senate version of the Fiscal Year 2022 Labor, Health and Human Services
Appropriations bill.
We also respectfully request the inclusion of the following NIDA
specific report language.
Opioid Initiative. The Committee continues to be concerned about
the opioid overdose epidemic and appreciates the important role that
research plays in the various federal initiatives aimed at this crisis.
The Committee is also aware of the most recent data from the Centers
for Disease Control and Prevention that shows opioid overdose
fatalities increasing from 2018 to 2019, with the primary driver being
the increased overdose deaths involving synthetic opioids, primarily
illicitly manufactured fentanyls. To combat this crisis the Committee
has provided within NIDA's budget no less than $270,295,000 for the
Institute's share of the HEAL Initiative and in response to rising
rates of stimulant use and overdose, the Committee has included
language expanding the allowable use of these funds to include research
related to stimulant use and addiction.
Methamphetamine and Other Stimulants. The Committee is concerned
that, according to data released by the Centers for Disease Control and
Prevention, 32,000 overdose deaths involved drugs in the drug
categories that include methamphetamine and cocaine in 2019, an
increase of over 700%. The sharp increase has led some to refer to
stimulant overdoses as the ``fourth wave'' of the current drug
addiction crisis in America following the rise of opioid-related deaths
involving prescription opioids, heroin, and fentanyl-related
substances. Methamphetamine is highly addictive and there are no FDA-
approved treatments for methamphetamine and other stimulant use
disorders. The Committee continues to support NIDA's efforts to address
the opioid crisis, has provided continued funding for the HEAL
Initiative, and supports NIDA's efforts to combat the growing problem
of methamphetamine and other stimulant use and related deaths.
Barriers to Research. The Committee is concerned that restrictions
associated with Schedule I of the Controlled Substance Act which
effectively limits the amount and type of research that can be
conducted on certain Schedule I drugs, especially opioids, marijuana or
its component chemicals and new synthetic drugs and analogs. At a time
when we need as much information as possible about these drugs and
antidotes for their harmful effects, we should be lowering regulatory
and other barriers to conducting this research. The Committee
appreciates NIDA's completion of a report on the barriers to research
that result from the classification of drugs and compounds as Schedule
I substances including the challenges researchers face as a result of
limited access to sources of marijuana including dispensary products.
COVID Pandemic and Impact on Substance Use Disorders. The Committee
is acutely aware of the risks that the ongoing COVID-19 pandemic poses
to individuals with substance use disorders. According to the Centers
for Disease Control and Prevention, drug overdose deaths accelerated
during the pandemic which saw over 81,000 drug overdose deaths in the
United States in the 12 months ending in May 2020, the highest number
of overdose deaths ever recorded in a 12-month period. Moreover,
research supported by the National Institute on Drug Abuse found that
individuals with substance use disorders are at increased risk for
COVID-19 and its more adverse outcomes. The Committee commends NIDA for
conducting research on the adverse impact of the pandemic on SUDs and
encourages the Institute to expand its research on these issues.
Raising Awareness and Engaging the Medical Community in Drug Abuse
and Addiction Prevention and Treatment. Education is a critical
component of any effort to curb drug use and addiction, and it must
target every segment of society, including healthcare providers
(doctors, nurses, dentists, and pharmacists), patients, and families.
Medical professionals must be in the forefront of efforts to curb the
opioid crisis. The Committee continues to be pleased with the NIDAMED
initiative, targeting physicians-in-training, including medical
students and resident physicians in primary care specialties (e.g.,
internal medicine, family practice, and pediatrics). NIDA should
continue its efforts in this area, providing physicians and other
medical professionals with the tools and skills needed to incorporate
substance use and misuse screening and treatment into their clinical
practices. The Committee recommends that NIDA increase its support for
the education of scientists and practitioners to find improved
prevention and treatments for substance use disorders as the Institute
has done for the COVID-19 pandemic.
Marijuana Research. The Committee is concerned that marijuana
policies on the federal level and in the states (medical marijuana,
recreational use, etc.) are being changed without the benefit of
scientific research to help guide those decisions. NIDA is encouraged
to continue supporting a full range of research on the health effects
of marijuana and its components, including research to understand how
marijuana policies affect public health.
Electronic Cigarettes. The Committee understands that electronic
cigarettes (e-cigarettes) and other vaporizing equipment are
increasingly popular among adolescents, and requests that NIDA continue
to fund research on the use and consequences of these devices.
In addition, we request the following report language within the
Office of the Director account:
The HEALthy Brain and Child Development (HBCD) Study. The Committee
recognizes and supports the NIH HEALthy Brain and Child
Development Study, which will establish a large cohort of
pregnant women from regions of the country significantly
affected by the opioid crisis and follow them and their
children for at least 10 years. This knowledge will be critical
to help predict and prevent some of the impacts of pre- and
postnatal exposure to drugs or adverse environments, including
risk for future substance abuse, mental disorders, and other
behavioral and developmental problems. The Committee recognizes
that the HBCD Study is supported in part by the NIH HEAL
Initiative, and NIH Institutes, Centers, and Offices (ICOs),
including OBSSR, ORWH, NIMHD, NIBIB, NIMHD, NIEHS, NICHD,
NINDS, NIAAA, NIMH, and NIDA, and encourages other NIH ICOs to
support this important study.
Substance use disorders (SUD) are costly to Americans; it ruins
lives, while tearing at the fabric of our society and taking a
financial toll on our resources. Over the past three decades, NIDA-
supported research has revolutionized our understanding of SUD as a
chronic, often-relapsing brain disease -this new knowledge has helped
to correctly emphasize the fact that SUD is a serious public health
issue that demands strategic solutions.
NIDA supports a comprehensive research portfolio that spans the
continuum of basic neuroscience, behavior and genetics research through
medications development and applied health services research and
epidemiology. While supporting research on the positive effects of
evidence-based prevention and treatment approaches, NIDA also
recognizes the need to keep pace with emerging problems. We have seen
encouraging trends in strategies to address these problems, but areas
of continuing significant concern include the recent increase in
fatalities due to heroin and synthetic fentanyl, as well as continued
illicit use of prescription opioids. Our knowledge of how drugs work in
the brain, their health consequences, how to treat people with SUDs,
and what constitutes effective prevention strategies has increased
dramatically due to research. However, because the number of
individuals who are affected is still rising, we need to continue the
work until this disease is both prevented and eliminated from society.
We understand that the FY2022 budget cycle will involve setting
priorities and accepting compromise, however, in the current climate we
believe a focus on substance use disorders deserves to be prioritized
accordingly. Thank you for your support for the National Institute on
Drug Abuse.
______
Prepared Statement of FSHD Society
Honorable Chairwoman Murray, Ranking Member Blunt, and
distinguished members of the Subcommittee, thank you for the
opportunity to testify. We are requesting the FY2022 appropriation of
an amount of $33 million for the agency U.S. DHHS National Institutes
of Health (NIH) program on research specifically directed at
facioscapulohumeral disease and facioscapulohumeral muscular dystrophy
(hereafter called FSHD).
FSHD is a heritable disease and one of the most common
neuromuscular disorders with a prevalence of 1:8,000.\1\ It affects
934,000 children and adults of both sexes worldwide. FSHD is
characterized by progressive loss of skeletal muscle strength that is
asymmetric in pattern and widely variable. Muscle weakness typically
starts at the face, shoulder girdle and upper arms, often progressing
to the legs, torso and other muscles. In addition to affecting muscle
it can bring with it respiratory failure and breathing issues,\62\
mild-profound hearing loss, eye problems and cardiac bundle blockage
and arrhythmias.\79\ FSHD causes significant disability and death
according the U.S. Centers for Disease Control and Prevention (CDC),
National Center on Birth Defects and Developmental Disabilities,
Atlanta, Georgia and others.\80,81\
FSHD is associated with epigenetic changes on the tip of human
chromosome 4q35 in the D4Z4 DNA macrosatellite repeat array region
leading to an inappropriate gain of expression (function) of the D4Z4-
embedded double homeobox 4 (DUX4) gene.\2\ DUX4 is a transcription
factor that kick starts the embryonic genome during the 2- to 8-cell
stage of development.\3-5\ Ectopic expression of DUX4 in skeletal
muscle is associated with the disease and the disease's pathophysiology
that leads to muscle death. DUX4 is never expressed in 'healthy'
muscle. FSHD has had few clinical trials,\6-10\ and currently there is
no cure or therapeutic option available to patients. DUX4 requires and
needs to activate its direct transcriptional targets for DUX4-induced
gene aberration and muscle toxicity.\11-24\ The genetics of FSHD are so
remarkable, that NIH Director Dr. Francis Collins said on the front
page of the New York Times, ``If we were thinking of a collection of
the genome's greatest hits, this [FSHD] would go on the list.'' \78\
Blocking DUX4's DNA, DUX4's RNA or DUX4's protein ability to
activate its targets has profound therapeutic relevance.\25\ The FSHD
scientific community has in recent years pioneered inroads to treating
FSHD using the enormous potential of genomic sequencing, genomic
medicine, gene editing and next generation diagnostics. Table 1 lists a
dozen approaches detailed in thirty-eight proof-of-concept publications
that molecular and genetic treatment approaches work in cellular and
animal models for FSHD. All with the central paradigm of the reduction
of: DUX4, DUX4 expression, DUX4 protein activity, or the effects of
DUX4-mediated toxicity. Strategies include modulating DUX4 repressive
pathways, targeting DUX4 mRNA, DUX4 protein, or cellular downstream
effects of DUX4 expression. Simply unfathomable as to why NIH funding
is this area is not increasing with the pace of discovery.
TABLE 1: Genetic Approaches with Potential to Treat FSHD
--Targeting the DUX4 gene itself by repression using CRISPR/dSaCas9
or CRISPR/dCas9-KRAB;
--Targeting and correcting the FSHD2 SMCHD1 gene mutation with
CRISPR/Cas9;
--Knockdown and silencing of the DUX4 gene by going after DUX4 mRNA
with antisense oligonucleotides and with RNA interference; U7-
asDUX4 snRNAs;
--Targeting DUX4 protein expression using through DNA aptamers;
proteins homologous to DUX4; and DNA decoys;
--Going after and controlling expression target downstream [post-
expression] of DUX4;
--Going after genetic modifiers of DUX4 expression and DUX4-mediated
toxicity between the DUX4 gene and DUX4 mRNA; G-quadruplexes
(GQs); and
--Targeting proteins that perturb DUX4-mediated toxicity or secondary
features of FSHD pathology.\26-63\
The clinical trials readiness priorities remain similar to last
year's testimony. The FSHD scientific community has listed emphasis
areas as: 1.) clinical trials readiness infrastructure and
therapeutics; 2.) direct and surrogate biomarkers; 3.) genetic testing,
genetics and epigenetics; 4.) imaging and outcome measures; and, 5.)
registries and patient focused and reported outcomes.\73\ The way to
measuring disease progression and the effectiveness and safety of drugs
remains deep and hard-going for industry, clinical partners and
patients.
Serendipitously, new NextGen genomic sequencing and diagnostic
technologies, as well as gene-targeted therapeutic approaches have
emerged that will be game changing for FSHD patients and families.
Understanding one's disease or condition is key for both mental and
physical health. This can also aid with family and life planning
decisions. With certainty many barriers to matching FSHD disease
severity to outcome measures would rapidly fall. We could better align
drug and therapeutic modalities with proper phenotypic/genotypic silos
of FSHD based on repeat unit, methylation ranges and other requisites
for FSHD. The current testing approach in the US, albeit excellent, has
created a drag on the momentum towards clinical trials. With therapies
on the way, identifying asymptomatic carriers and those that will
decades later have later onset or mild symptoms, will allow us to then
halt the disease in its early formative stages.\64,66-69,72\
Recently in 2021, two excellent papers were published on FSHD and
DUX4. Both were outstanding--one was using Oxford Nanopore long read
sequencing of direct-RNA to locate DUX4 gene targets and the other was
a careful study of DUX4 expression in its endogenous [native] form
versus the more common recombinant [created] form used in the
laboratory.\70,71\ As I read, I asked myself of each: ``does this tell
us anything more about what DUX4's function is? No. How DUX4 works?
Nada. Or how DUX4 causes FSHD pathophysiology? Nothing at all. How and
if DUX4 itself is toxic to skeletal muscle? Zilch. If all research
using FSHD transgenic cells an animals is simply result of an artifact?
Not sure now.'' Both papers yield the same thought: though DUX4 is the
prime therapeutic target--we know next to nothing about it. It is still
a complete black box; yet the central focus for FSHD therapy. Questions
and areas of research interest emerge from these publications and
allied considerations; flowing fast--each one hypothesis worthy of
several NIH grants. ``Is DUX4 cytotoxicity pathogenic in vivo? How does
expression of DUX4 lead to muscle loss? What is the role of non-muscle
cells in FSHD pathology? Can muscle pathology be stopped once it has
started (as visualized via MRI images) or is it too late? How is DUX4
bursting regulated in vivo? What other cell types express DUX4 in FSHD
and/or healthy individuals? Does the DUX4 mRNA play a nuclear role in
FSHD? Are there noncoding RNA roles for DUX4? Are DUX4 induced protein
aggregates cause or consequence for FSHD? Does autoimmunity play a role
in FSHD? Are there other DUX4-dependent therapeutic targets?'' NIH
should certainly encourage proposals here. New data/information
generated on the basic mechanism of DUX4 and how it causes muscle
disease has the potential to focus the design of future clinical trials
on muscles and measurements that will increase the rigor of the design
and decrease the number of individuals necessary for initial tests of
drug activity. It is absolutely necessary to increase our resolution,
clarity and understanding of what DUX4 is and what it does to muscle in
FSHD. The gains in this area will effectively unpin or untether FSHD
from the difficulty category of ``slowly progressing neuromuscular
diseases remaining recalcitrant'' to timely ascertainment that a
clinical intervention can work.
Your Subcommittee and Congress in partnership with NIH, patients
and scientists have made truly outstanding progress in understanding
and treating the nine major types of muscular dystrophy through the
Muscular Dystrophy Community Assistance, Research and Education
Amendments of 2001 (MD-CARE Act, Public Law 107-84). Since passing the
MD CARE Act in 2001, NIH funding for FSHD has not kept up pace with
scientific opportunities listed herein. The NIH is the principal
worldwide source of funding of research on FSHD. Currently active
projects are $16.554 million FY2022 (current actual 23June2021), a 21%
portion of the estimated $80 million spent on all muscular dystrophies.
(source: NIH Research Portfolio Online Reporting Tools (RePORT) keyword
'FSHD or facioscapulohumeral or landouzy-dejerine').
FSHD RESEARCH DOLLARS & FSHD AS A PERCENTAGE OF TOTAL NIH MUSCULAR DYSTROPHY FUNDING
[Dollars in millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiscal Year 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
All MD ($ millions).......................... $83 $86 $75 $75 $76 $78 $77 $79 $81 $81 $83 $88e $80e
FSHD ($ millions)............................ $5 $6 $6 $5 $5 $7 $8 $9 $11 $11 $10 $11e $10e
FSHD (% total MD)............................ 6% 7% 8% 7% 7% 9% 10% 11% 14% 14% 12% 13% 13%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sources: NIH/OD Budget Office & NIH OCPL & NIH RePORT RCDC (e=estimate, a=actual)
We request for FY2022, a doubling of the NIH FSHD research
portfolio to $33 million. At this moment in time, FSHD needs an
infusion of NIH grants both submitted and funded. NIH needs to increase
funding by adding exploratory/developmental research grants (parent
R21) and research project grants (parent R01) in areas outlined by
experts both in this testimony and in the 2015 DHHS NIH MD Plan.\77\
NIH can issue targeted funding announcements covering FSHD. These
efforts will help NIH receive more grant applications. This is NIH's
wheelhouse and forte without a doubt.
Madam Chairman, this is my sixty-second testimony before the U.S.
Congress' Appropriations Subcommittee on this matter. My FSHD is a
strong fort; it has lasted my lifetime of fifty-nine years. That is a
long time to live with a disease of this burden.\80\ I hope with your
help and action to be able to outlive my disease. I need your help, my
friends and fellow FSHD patients and families need your help. Please
implore NIH to double funding on FSHD and kindly remember that our
lives matter. Madam Chairman, thank you again for your help and
efforts.
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\56\ Lemmers RJLF, van der Vliet PJ, Blatnik A, Balog J, Zidar J,
Henderson D, Goselink R, Tapscott SJ, Voermans NC, Tawil R, Padberg
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\57\ Rashnonejad A, Amini-Chermahini G, Taylor NK, Wein N, Harper
SQ. Designed U7 snRNAs inhibit DUX4 expression and improve FSHD-
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\58\ Himeda CL, Jones TI, Jones PL. Targeted epigenetic repression
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\59\ Schatzl T, Kaiser L, Deigner HP. Facioscapulohumeral muscular
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\60\ Lim KRQ, Yokota T. Genetic Approaches for the Treatment of
Facioscapulohumeral Muscular Dystrophy. Front Pharmacol. 2021 Mar
12;12:642858. doi: 10.3389/fphar.2021.642858. eCollection 2021. Review
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\61\ Mellion ML, Ronco L, Berends CL, Pagan L, Brooks S, van Esdonk
MJ, van Brummelen EMJ, Odueyungbo A, Thompson LA, Hage M, Badrising UA,
Raines S, Tracewell WG, van Engelen B, Cadavid D, Groeneveld GJ. Phase
1 clinical trial of losmapimod in facioscapulohumeral dystrophy:
Safety, tolerability, pharmacokinetics, and target engagement. Br J
Clin Pharmacol. 2021 Apr 30. doi: 10.1111/bcp.14884. (2021).
\62\ Lu-Nguyen N, Malerba A, Herath S, Dickson G, Popplewell L.
Systemic antisense therapeutics inhibiting DUX4 expression ameliorates
FSHD-like pathology in an FSHD mouse model. Hum Mol Genet. 2021 May
13:ddab136. doi: 10.1093/hmg/ddab136. (2021).
\63\ Das S, Chadwick BP. CRISPR mediated targeting of DUX4 distal
regulatory element represses DUX4 target genes dysregulated in
Facioscapulohumeral muscular dystrophy. Sci Rep. 2021 Jun
15;11(1):12598. doi: 10.1038/s41598-021-92096-0. (2021).
\64\ Goselink RJM, Mul K, van Kernebeek CR, Lemmers RJLF, van der
Maarel SM, Schreuder THA, Erasmus CE, Padberg GW, Statland JM, Voermans
NC, van Engelen BGM. Early onset as a marker for disease severity in
facioscapulohumeral muscular dystrophy. Neurology. 2019 Jan
22;92(4):e378-e385. doi: 10.1212/WNL.0000000000006819. Epub 2018 Dec 19
(2019).
\65\ Henke C, Spiesshoefer J, Kabitz HJ, Herkenrath S, Randerath W,
Brix T, Gorlich D, Young P, Boentert M. Respiratory muscle weakness in
facioscapulohumeral muscular dystrophy. Muscle Nerve. 2019
Dec;60(6):679-686. doi: 10.1002/mus.26717. Epub 2019 Oct 23 (2019).
\66\ Sacconi S, Briand-Suleau A, Gros M, Baudoin C, Lemmers RJLF,
Rondeau S, Lagha N, Nigumann P, Cambieri C, Puma A, Chapon F, Stojkovic
T, Vial C, Bouhour F, Cao M, Pegoraro E, Petiot P, Behin A, Marc B,
Eymard B, Echaniz-Laguna A, Laforet P, Salviati L, Jeanpierre M,
Cristofari G, van der Maarel SM. FSHD1 and FSHD2 form a disease
continuum. Neurology. 2019 May 7;92(19):e2273-e2285. doi: 10.1212/
WNL.0000000000007456. Epub 2019 Apr 12 (2019).
\67\ Salort-Campana E, Fatehi F, Beloribi-Djefaflia S, Roche S,
Nguyen K, Bernard R, Cintas P, Sole G, Bouhour F, Ollagnon E, Sacconi
S, Echaniz-Laguna A, Kuntzer T, Levy N, Magdinier F, Attarian S. Type 1
FSHD with 6-10 Repeated Units: Factors Underlying Severity in Index
Cases and Disease Penetrance in Their Relatives Attention. Int J Mol
Sci. 2020 Mar 23;21(6):2221. doi: 10.3390/ijms21062221 (2020).
\68\ Wong CJ, Wang LH, Friedman SD, Shaw D, Campbell AE, Budech CB,
Lewis LM, Lemmers RJFL, Statland JM, van der Maarel SM, Tawil RN,
Tapscott SJ. Longitudinal measures of RNA expression and disease
activity in FSHD muscle biopsies. Hum Mol Genet. 2020 Apr
15;29(6):1030-1043. doi: 10.1093/hmg/ddaa031. PMID: 32083293 (2020).
\69\ Rieken A, Bossler AD, Mathews KD, Moore SA. CLIA Laboratory
Testing for Facioscapulohumeral Dystrophy: A Retrospective Analysis.
Neurology. 2021 Feb 16;96(7):e1054-e1062. doi: 10.1212/
WNL.0000000000011412. Epub 2020 Dec 21 (2021).
\70\ Chau J, Kong X, Viet Nguyen N, Williams K, Ball M, Tawil R,
Kiyono T, Mortazavi A, Yokomori K. Relationship of DUX4 and target gene
expression in FSHD myocytes. Hum Mutat. 2021 Jan 27. doi: 10.1002/
humu.24171 (2021).
\71\ Mitsuhashi S, Nakagawa S, Sasaki-Honda M, Sakurai H, Frith MC,
Mitsuhashi H. Nanopore direct RNA sequencing detects DUX4-activated
repeats and isoforms in human muscle cells. Hum Mol Genet. 2021 Mar
9:ddab063. doi: 10.1093/hmg/ddab063 (2021).
\72\ Goselink RJM, Schreuder THA, Mul K, Voermans NC, Erasmus CE,
van Engelen BGM, van Alfen N. Muscle ultrasound is a responsive
biomarker in facioscapulohumeral dystrophy.Neurology. 2020 Apr
7;94(14):e1488-e1494. doi: 10.1212/WNL.0000000000009211. (2020).
\73\ Wang LH, Shaw DWW, Faino A, Budech CB, Lewis LM, Statland J,
Eichinger K, Tapscott SJ, Tawil RN, Friedman SD. Longitudinal study of
MRI and functional outcome measures in facioscapulohumeral muscular
dystrophy. BMC Musculoskelet Disord. 2021 Mar 10;22(1):262. doi:
10.1186/s12891-021-04134-7 (2021).
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Maarel SM, Joosten LAB, van Engelen BGM, Pruijn GJM. Profiling Serum
Antibodies Against Muscle Antigens in Facioscapulohumeral Muscular
Dystrophy Finds No Disease-Specific Autoantibodies. J Neuromuscul Dis.
2021 May 15. doi: 10.3233/JND-210653. (2021).
\75\ Karpukhina A, Galkin I, Ma Y, Dib C, Zinovkin R, Pletjushkina
O, Chernyak B, Popova E, Vassetzky Y. Analysis of genes regulated by
DUX4 via oxidative stress reveals potential therapeutic targets for
treatment of facioscapulohumeral dystrophy. Redox Biol. 2021
Jul;43:102008. doi: 10.1016/j.redox.2021.102008. (2021).
\76\ Banerji CRS, Zammit PS. Pathomechanisms and biomarkers in
facioscapulohumeral muscular dystrophy: roles of DUX4 and PAX7. EMBO
Mol Med. 2021 Jun 21:e13695. doi: 10.15252/emmm.202013695. (2021).
\77\ Rieff HI, Katz SI et al. The Muscular Dystrophy Coordinating
Committee Action Plan for the Muscular Dystrophies. Muscle Nerve. 2016
Mar 21. [Epub ahead of print] (2016).
\78\ Kolata, G., Reanimated 'Junk' DNA Is Found to Cause Disease.
New York Times, Science. Published online: August 19, 2010 http://
www.nytimes.com/2010/08/20/science/20gene.html.
\79\ Ducharme-Smith A, Nicolau S, Chahal CAA, Ducharme-Smith K,
Rehman S, Jaliparthy K, Khan N, Scott CG, St Louis EK, Liewluck T,
Somers VK, Lin G, Brady PA, Milone M. Cardiac Involvement in
Facioscapulohumeral Muscular Dystrophy (FSHD). Front Neurol. 2021 May
24;12:668180. doi: 10.3389/fneur.2021.668180. (2021).
\80\ Blokhuis AM, Deenen JCW, Voermans NC, van Engelen BGM, Kievit
W, Groothuis JT. The socioeconomic burden of facioscapulohumeral
muscular dystrophy. J Neurol. 2021 May 27. doi: 10.1007/s00415-021-
10591-w. (2021).
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JG, Weinert RO, Do TQN, Street N; Muscular Dystrophy Surveillance,
Tracking, and Research Network (MD STARnet). Characterization of
individuals with selected muscular dystrophies from the expanded pilot
of the Muscular Dystrophy Surveillance, Tracking and Research Network
(MD STARnet) in the United States. Birth Defects Res. 2021 Apr
15;113(7):560-569. doi: 10.1002/bdr2.1764. (2020).
[This statement was submitted by Daniel Paul Perez, Co-Founder &
Director Emeritus and past Chairman, President & Chief Executive
Officer, Chief Scientific Officer, FSHD Society.]
______
Prepared Statement of the GBS|DCIDP Foundation International
summary of recommendations for fiscal year 2022
_______________________________________________________________________
--Provide $46.1 billion for the National Institutes of Health (NIH)
and proportional increases across its Institutes and Centers
--Continue expanding GBS research supported by NIH with proportional
funding increases for the National Institute of Neurological
Disorders and Stroke (NINDS), and the National Institute of
Allergy and Infectious Diseases (NIAID)
--Provide $10 billion for the Centers for Disease Control and
Prevention (CDC) and $5 million for the Chronic Disease
Education and Awareness Program
_______________________________________________________________________
Chairwoman Murray, Ranking Member Blunt and distinguished members
of the Subcommittee, thank you for your time and your consideration of
the priorities of the community of individuals impacted by Guillain-
Barre Syndrome (GBS), Chronic Inflammatory Demyelinating Polyneuropathy
(CIDP), and related conditions as you work to craft the FY2022 L-HHS
Appropriations Bill.
about gbs, cidp, variants, and related conditions
Guillain-Barre Syndrome
Guillain-Barre Syndrome (GBS) is an inflammatory disorder of the
peripheral nerves outside the brain and spinal cord. GBS is
characterized by the rapid onset of numbness, weakness, and often
paralysis of the legs, arms, breathing muscles, and face. Paralysis is
ascending, meaning that it travels up the limbs from fingers and toes
towards the torso. Loss of reflexes, such as the knee jerk, are usually
found. Usually, a new case of GBS is admitted to ICU (Intensive Care)
to monitor breathing and other body functions until the disease is
stabilized. Plasma exchange (a blood ``cleansing'' procedure) and high
dose intravenous immune globulins are often helpful to shorten the
course of GBS. The acute phase of GBS typically varies in length from a
few days to months. Patient care involves the coordinated efforts of a
team such as a neurologist, physiatrist (rehabilitation physician),
internist, family physician, physical therapist, occupational
therapist, social worker, nurse, and psychologist or psychiatrist.
Recovery may occur over six months to two years or longer. A
particularly frustrating consequence of GBS is long-term recurrences of
fatigue and/or exhaustion as well as abnormal sensations including pain
and muscle aches.
Chronic Inflammatory Demyelinating Polyneuropathy
CIDP is a rare disorder of the peripheral nerves characterized by
gradually increasing weakness of the legs and, to a lesser extent, the
arms. It is the gradual onset as well as the chronic nature of CIDP
that differentiates it from GBS. Like GBS, CIDP is caused by damage to
the covering of the nerves, called myelin. It can start at any age and
in both genders. Weakness occurs over two or more months. Unlike GBS,
CIDP is chronic, with symptoms constantly waxing and waning. Left
untreated, 30% of CIDP patients will progress to wheelchair dependence.
Early recognition and treatment can avoid a significant amount of
disability. Post-treatment life depends on whether the disease was
caught early enough to benefit from treatment options. The gradual
onset of CIDP can delay diagnosis by several months or even years,
resulting in significant nerve damage that may take several courses of
treatment before benefits are seen. The chronic nature of CIDP
differentiates long-term care from GBS patients. Adjustments inside the
home may need to be made to facilitate a return to normal life.
about the foundation
The Foundation's vision is that every person afflicted with GBS,
CIDP, or variants has convenient access to early and accurate
diagnosis, appropriate and affordable treatments, and dependable
support services.
The Foundation's mission is to improve the quality of life for
individuals and families across America affected by GBS, CIDP, and
their variants by:
--Providing a network for all patients, their caregivers and families
so that GBS or CIDP patients can depend on the Foundation for
support, and reliable up-to-date information.
--Providing public and professional educational programs worldwide
designed to heighten awareness and improve the understanding
and treatment of GBS, CIDP and variants.
--Expanding the Foundation's role in sponsoring research and engaging
in patient advocacy.
centers for disease control and prevention
CDC and the National Center for Chronic Disease Prevention and
Health Promotion (NCCDPHP) have resources that could be brought to bear
to improve public awareness and recognition of GBS, CIDP and related
conditions. The Foundation supports a meaningful increase to the
Centers for Disease Control and Prevention as well as continued support
of the Chronic Disease Education and Awareness Program. This program
seeks to provide collaborative opportunities for chronic disease
communities such as ours that lack dedicated funding from ongoing CDC
activities. Such a mechanism allows public health experts at the CDC to
review project proposals on an annual basis and direct resources to
high impact efforts in a flexible fashion.
national institutes of health
NIH hosts a modest research portfolio focused on GBS, CIDP,
variants, and related conditions. This research has led to important
scientific breakthroughs and is well positioned to vastly improve our
understanding of the mechanism behind these conditions. We ask that
resources continue to be used to support the important collaboration
between NIAID, NINDS and the GBS|DCIDP community. Last May we
participated in a conference with NINDS that discussed how intramural
and extramural researchers can develop a roadmap that would lead
research into these conditions into the next decade, and encourage
younger investigators to apply for grants that lead to sustained
research activities. We are continuing to have conversations with the
leadership of both institutes to facilitate follow up and plan for a
more robust agenda and list of goals for a future in person conference.
In our meetings with the leadership, we also spoke about the
possibilities of cross-institute work between NINDS and NIAID to expand
the research and understanding of the link between Zika and GBS. While
such a conference would not require additional appropriations, the
Foundation urges you to provide NIH with meaningful funding increases
to facilitate growth in the GBS, CIDP, and related conditions research
portfolio.
patient access
As we have seen from communities that currently have access to home
infusion, such as primary immunodeficiency diseases, the ability to
choose the home as the preferred site of care has tremendous benefit in
terms of health outcomes and overall convenience for patients.
Individuals with CIDP and MMN often face mobility issues as limbs
suffer nerve damage. Traveling to receive an infusion presents a
tremendous hardship to many patients and their families. This hardship
greatly affects rural patients who have to travel hundreds of miles to
major cities in order to receive treatment, which can be both
inconvenient and costly. The Foundation has seen that when there are
obstacles to receiving regular infusions, patients tend to skip
scheduled infusions, which leads to progressive disability. Many CIDP
and MMN patients have access to IVIG home infusion through private
insurance, which allows them to lead productive and active lives. When
these individuals age on to Medicare, they can face disruption in their
routine and suboptimal circumstances when managing their condition.
Further, because the body's immune system is depressed at the end of an
infusion cycle, CIDP and MMN patients face an elevated risk of
contracting illness from visiting well-traveled sites of care for
infusions. Most importantly, patients and physicians should have the
authority to choose their preferred site of care. We hope that members
of this subcommittee and Congress as a whole support legislation that
will grant our patients this important access.
The Foundation was founded 40 years ago, and the four pillars that
guide our mission are: support, education, advocacy, and research. Our
patients rely on the premier research that is carried out at the NIH to
improve the diagnosis and treatment process of these devastating
illnesses. Without appropriate funding to the NIH and CDC, my fear as a
parent of a GBS survivor and the Executive Director of the Foundation,
is that many patients will needlessly suffer. There is so much to
learn; there is no bio-marker and we do not know why the immune system
reacts to trigger these conditions. I ask the Committee to provide
$46.1 billion to the NIH with proportional increases to NIAID and NINDS
to continue the potentially lifesaving work being done for our
community, and ask for Congressional support of our initiative to
improve access to life-saving treatments.
[This statement was submitted by Lisa Butler, Executive Director,
GBS|DCIDP Foundation International.]
______
Prepared Statement of GEAR UP
Distinguished members of the Senate Labor-Health and Human
Services-Education Appropriations Subcommittee, thank you for the
giving me the opportunity to provide testimony on the profound impact
that the Gaining Early Awareness and Readiness for Undergraduate
Programs (GEAR UP) initiative has had on my life. My name is William
Ruiz, and it is my honor and pleasure to be writing this testimonial on
behalf of GEAR UP alumni and over half a million GEAR UP students
across the country. Given the program's return on investment, I urge
the committee to appropriate $435,000,000 for GEAR UP in fiscal year
2022 to support an additional 100,000 students across our country so
that they, too, can have the support I received through GEAR UP.
GEAR UP provides 6- or 7-year grants to states and partnerships
comprised of K-12, higher education, and community-based organizations
that strengthen pathways to college and careers in low-income
communities. GEAR UP exposes students, and their families, starting in
the 7th grade to comprehensive interventions that follow them through
high school graduation and optionally through the first year of
postsecondary education. GEAR UP uses early and sustained interventions
to ensure that students are successful in rigorous courses, are
prepared for life beyond high school, and ultimately enroll in a high-
quality certificate, associates', or bachelors' degree program that
suits their goals. In the most recent year in which we had a large
class of graduating seniors, the postsecondary enrollment rates of GEAR
UP students were over 31% higher than the rates for low-income students
nationally.\1\ Considering that GEAR UP achieves this critical goal at
a cost of approximately $694 per student, per year, I strongly believe
that the investment in GEAR UP pays significant dividends. GEAR UP is a
powerful catalyst for sustained community improvement.
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\1\ U.S. Department of Education (2016). FY 2017 Department of
Education Justifications of Appropriation Estimates to the Congress:
Higher Education (Volume II). Retrieved from: https://www2.ed.gov/
about/overview/budget/budget17/justifications/index.html.
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Being the son of immigrant parents and growing up in a low-
socioeconomic neighborhood in Los Angeles, California, I never
envisioned myself going to college. My parents worked exceptionally
hard to provide for my siblings and me, but because they had to drop
out of school at a very young age to leave Mexico and move to the
United States, they had very little knowledge of the education system.
While I wasn't introduced to higher education by my family, my parents
did teach me about the value of hard work and made sure that I attained
good grades throughout my time in K-12 education. As I navigated my way
through elementary and middle school, I always looked forward to high
school graduation because I thought that that would be the end of my
educational journey. It was always my plan to graduate high school and
enter the workforce full-time, just like how my older siblings did. It
wasn't until I was introduced to the GEAR UP program in 7th grade that
I was exposed to college. At that time, college was the last thing on
my mind, but the GEAR UP staff continued to remind us that they would
pack up their office and follow us to our local high school.
Fast forwarding to my first day at Benjamin Franklin High School, I
remember the first adult I saw on campus: GEAR UP Counselor Mr. Burton.
I was shocked to see that they were serious when they said they would
follow us. Throughout the rest of my freshman year, we would
participate in various workshops with GEAR UP. I always enjoyed talking
to the GEAR UP team, but I still couldn't see myself pursuing higher
education. At the end of my first year of high school, GEAR UP started
recruiting students for their peer mentor and summer programs.
After signing up for summer school and participating in the peer
mentor camps with GEAR UP, I immersed myself in all things GEAR UP. At
the beginning of my sophomore year, I met an individual who, to this
day, has a special place in my heart. I can never truly thank Mr.
Robert Aguirre for all the help and support he has provided me with
since 2009. While I had the grades to attend college and pursue a
degree, Mr. Aguirre provided me with the structure and gave me all the
resources I needed to pursue higher education. Growing up in a
neighborhood with a lot of gang violence and having friends who dropped
out of school a young age, it was reassuring to have a positive male
role model that I could look up to. I always heard that it only takes
one adult to care for a student to do well in school. I can undoubtedly
say Mr. Aguirre was that person for me. I always knew that if I had any
issues regarding school, I could easily walk to the GEAR UP office to
talk to him.
I wouldn't have gone to a 4-year university if it wasn't for Mr.
Aguirre and GEAR UP. Not only did GEAR UP teach me about admission
requirements and financial aid, but they also exposed me to different
colleges and universities. One of my fondest memories of high school
was traveling up the California coastline on a bus to visit colleges in
Northern California. Because of the field trips and the exposure to
colleges, I began to imagine myself on college campuses. When I started
my senior year of high school, the GEAR UP staff sat me down in the
school's computer lab to apply to college. As someone who had simply
gone through the motions, I really appreciated GEAR UP for giving me
that extra push to take education more seriously.
I will always be grateful for all the love and support that GEAR UP
provided as I navigated high school. Yes, GEAR UP is an acronym and a
federally funded program, but to me, GEAR UP is family.
Because of what GEAR UP gave me, I wanted to give back to GEAR UP.
I currently have the honor and privilege of working with over 800
students in the Compton Unified School District as a GEAR UP Program
Coordinator. I am also a Founding Board Member of the GEAR UP Alumni
Association. The GEAR UP Alumni Association aims to support GEAR UP
Alumni so that GEAR UP students can not only get to college but also
graduate. Our vision is to eventually branch out and support GEAR UP
students across the country.
I am also happy to share with you that beginning in August 2021, I
will be pursuing my Master of Arts in Diverse Community Development
Leadership (DCDL) at California State University, Northridge. As a GEAR
UP alum and current educator, I want to continue my educational journey
so that I can best assist students like me. My initial goal was only to
graduate high school. Now, I am proud of the fact that I am the first
in my family to graduate college and will be the first to receive a
graduate degree.
None of this would have been possible without GEAR UP. I will
always be open and honest about my journey because there are a lot of
students who have similar backgrounds as me. I wake up every day
grateful that I was able to be a GEAR UP student because it changed my
life for the better.
As you take on the work of preparing for the fiscal year 2022
appropriations, I urge you to consider increasing the investment in the
GEAR UP program to $435,000,000 so that 100,000 more students just like
me can benefit from the program. Thank you to the committee for taking
the time to read my testimony.
Prepared Statement of Global Health Council
Global Health Council (GHC) is the leading membership organization
for nonprofits, businesses, universities, and individuals dedicated to
saving lives and improving the health of people worldwide. GHC thanks
the Subcommittee for the opportunity to share this testimony in support
of global health programs under the jurisdiction of the Departments of
Labor and Health and Human Services. For Fiscal Year (FY) 2022, GHC
encourages continued support for global health at a minimum of FY21
levels enacted by Congress. However, in order to achieve U.S. global
health goals and commitments, we ask that you support a greater
investment in global health programs for FY22, which includes at a
minimum: $6,356,000,000 for the National Institute of Allergy and
Infectious Disease (NIAID), $3,845,000,000 for the Office of AIDS
Research, and $91,000,000 for the Fogarty International Center at the
National Institutes of Health (NIH); an investment of $735,000,000 for
the Center for Emerging Zoonotic and Infectious Diseases, $300,000,000
for the Infectious Diseases Rapid Response Fund, and no less than
$898,000,000 for the Center for Global Health at the Centers for
Disease Control and Prevention (CDC).
In light of the COVID-19 pandemic, we must urge Congress to
appropriate funds to sustain America's legacy abroad and to support
existing programs in their ongoing response to the coronavirus. It is
our hope that appropriators will consider the additional needs and
negative effects of the COVID-19 pandemic when making appropriations
for FY22. We have seen significant declines across global health
programs in their capacity to reach the same or more people for
preventative care, ongoing care for diseases ranging from HIV/AIDS,
tuberculosis, non-communicable diseases, malaria, and more.
We know that these programs work and have secured their place as
some of the most critical and successful tools for U.S. global health.
By investing in these programs, the United States is continuing to
build healthier and more self-reliant communities, which ultimately
become economically and politically stable. We have seen the COVID-19
pandemic exacerbate weak points in health systems in rich and poorer
countries alike, ultimately weakening our own health system. It
highlighted inefficiencies and a sheer lack of access to care around
the world. We cannot afford to lose more ground on the progress that
the United States has already made towards building healthier
communities. A failure to backstop these investments would roll back
the progress we have spent decades achieving and ultimately undermine
U.S. foreign policy and global health priorities.
We undeniably live in a global environment. Global health is
important for medical professionals here at home, too. Every year, more
than 500 million people cross borders in planes, and with them the
potential for infectious diseases to enter our country, demanding more
of our health workforce. But U.S.-based providers and other responders
have the opportunity to learn from health programs abroad about how
best to tackle diseases whenever they arrive. We have an opportunity
here, to mobilize everyone involved in health, from scientists,
pharmaceutical companies, frontline workers, advocates, and
policymakers, to create a world where health threats can become a thing
of the past.
We must continue to build upon the hard work and achievements of
previous years in order to prevent the persistent global health
challenges of our time and ensure a healthy future for citizens around
the world. In our current environment, in response to COVID-19, we must
consider increasing investments in global health and development
assistance funding. We have a moral obligation to resolve the
challenges that U.S. global health programs now face in light of the
pandemic. And it is in our national interest to demonstrate that these
are essential commitments.
Thank you for your consideration of this request.
[This statement was submitted by Kiki Kalkstein, Director of
Advocacy &
Engagement, Global Health Council.]
______
Prepared Statement of the Global Health Technologies Coalition
On behalf of the Global Health Technologies Coalition (GHTC), a
group of 37 nonprofit organizations, academic institutions, and aligned
businesses advancing policies to accelerate the creation of new drugs,
vaccines, diagnostics, and other tools that bring healthy lives within
reach for all people, I am providing testimony on fiscal year 2022
(FY22) appropriations for the National Institutes of Health (NIH), the
Centers for Disease Control and Prevention (CDC), and the Biological
Advanced Research and Development Authority (BARDA). These
recommendations reflect the needs expressed by our members working
across the globe to develop new and improved technologies for the
world's most pressing health issues. We appreciate the Committee's
support for global health, particularly for continued research and
development (R&D) to advance new drugs, vaccines, diagnostics, and
other tools for long-standing and emerging health challenges, including
COVID-19. To accelerate progress toward lifesaving tools for a range of
health threats, we respectfully request increased funding for NIH,
including an additional $10 million for the Fogarty International
Center (FIC); funding to match CDC's increased responsibilities in
global health and global health security-in line with the overall
increase for CDC proposed in the President's Discretionary Budget
Request, which should be reflected in increases for the Center for
Global Health (CGH) and National Center for Emerging Zoonotic and
Infectious Diseases (NCEZID)--and the creation of a new, dedicated
funding line to support BARDA's critical work in emerging infectious
diseases (EIDs), which accelerated to unprecedented levels over the
past year and should be sustainably funded beyond the COVID-19
pandemic.
GHTC members strongly believe that sustainable investment in R&D
for a broad range of neglected diseases and health conditions is
critical to tackling both long-standing and emerging global health
challenges that impact people around the world and in the United
States. Coordination is also key: we urge the Committee to request that
leaders of Department of Health and Human Services agencies work with
counterparts at the State Department and the US Agency for
International Development to develop a cross-government global health
R&D strategy to ensure that US investments are efficient, coordinated,
and streamlined.
While we have made tremendous gains in global health over the past
15 years, millions of people around the world are still threatened by
neglected diseases and conditions. In 2019, tuberculosis (TB) killed
1.4 million people, surpassing deaths from HIV/AIDS, while 1.7 million
people were newly diagnosed with HIV. Nearly half the global population
remains at risk for malaria, and drug-resistant strains are growing.
Women and children remain the most vulnerable with around 68 percent of
all global maternal and child deaths occurring in sub-Saharan Africa
and 1 out of every 13 children in the region dying before the age of 5.
These figures highlight the tremendous global health challenges that
remain and the need for sustained investment in global health R&D to
deliver new tools, both to address unmet global health needs and to
address challenges of drug resistance, toxic treatments, and health
technologies that are difficult to administer in poor, remote, and
unstable settings.
The COVID-19 pandemic has again demonstrated that we do not have
all the tools needed to prevent, diagnose, and treat many neglected and
EIDs--a reality foreshadowed by the recent Zika and Ebola epidemics.
The lifesaving effects of the first COVID-19 vaccines demonstrate the
power of having the right tools to respond to a health emergency. These
new vaccines, developed with critical funding from BARDA, NIH, and
other US government partners, are highly effective and built upon past
global health research advances. Notably, the Johnson & Johnson vaccine
is based on technology used in its Ebola vaccine and Zika, respiratory
syncytial virus, and HIV/AIDS vaccine candidates, and the Moderna-
National Institute of Allergy and Infectious Diseases (NIAID) vaccine
platform was previously being used to develop vaccines against other
respiratory viruses and the chikungunya virus. This demonstrates how
strong, sustained investment in R&D allows us to tackle today's health
threats and prepare for those of the future. The United States remains
at the forefront of global health innovation because of long-term
investments in R&D agencies such as NIH, CDC, and BARDA.
NIH: The groundbreaking science conducted at NIH has long
underpinned US leadership in biomedical research. Within NIH, NIAID,
the Office of AIDS Research, and FIC all play critical roles in
developing new health technologies that save lives at home and around
the world. FIC, in particular, is a leader in accelerating global
scientific progress through international research partnerships,
technical assistance, and training. Many FIC-trained scientists have
led their countries' responses to COVID-19, Zika, and Ebola, as well as
long-standing challenges such as HIV/AIDS. COVID-19 has underscored
that science capacity gaps remain between low- and middle-income
countries and high-income countries. With additional funding, FIC could
leverage its extensive network and training capacity to improve global
genomic surveillance and coordination. We urge Congress to request
information from FIC on how it might address global scientific capacity
gaps in modeling, genomic surveillance, researcher training, and
pandemic preparedness and urge appropriators to consider sustainably
increasing FIC's relatively modest budget by $10 million dollars in
each of the next five fiscal years to enable work in new areas.
Across NIAID, FIC, and other institutes and centers, NIH leadership
has long supported the vital role the agency plays in global health R&D
and has named global health as one of the agency's top five priorities.
It remains critical that support for NIH extend to all pressing areas
of research--including research in neglected diseases and EIDs.
CDC: CDC makes significant contributions to global health research,
particularly through CGH and NCEZID. CDC's ability to respond to
disease outbreaks is essential to protecting the health of citizens
both at home and abroad, and the work of its scientists is vital to
advancing the development of tools, technologies, and techniques to
detect, prevent, and respond to urgent public health threats. CDC
monitors 30 to 40 international public health threats each day, has
identified disease outbreaks in more than 150 countries, responded to
more than 2,000 public health emergencies, and discovered 12 previously
unknown pathogens--and in complement to these disease monitoring and
detection functions, plays a leading role in related R&D. Important
work at NCEZID includes the development of diagnostics, including the
first diagnostic test for COVID-19 with authorization from the US Food
and Drug Administration and Trioplex, a diagnostic that can
differentiate Zika, dengue, and chikungunya viruses. NCEZID is a leader
in early-stage R&D for vaccines for infectious diseases such as Nipah
virus and dengue, Lassa, and Rift Valley fevers. The Center also plays
a leading role in the National Strategy for Combating Antibiotic-
Resistant Bacteria, to prevent, detect, and control outbreaks of
antibiotic-resistant pathogens, such as drug-resistant TB.
In complement, CGH is a global leader in immunization, public
health capacity-building, and preventing, detecting, and responding to
infectious diseases. Programs at CGH--including the Divisions of Global
HIV and TB, Global Immunization, Parasitic Diseases and Malaria, and
Global Health Protection--have yielded advances in the development of
vaccines, drugs, and other tools to combat HIV/AIDS, TB, malaria, and
neglected tropical diseases like leishmaniasis and dengue fever. CGH
develops and validates innovative tools for use by US bilateral and
multilateral global health programs and leads laboratory efforts to
monitor and combat drug and insecticide resistance to ensure that
global health programs are tailored for maximum impact.
As global disease outbreaks have grown in frequency and intensity,
CDC's work in novel technology development and global health security
has only become more important. This includes the agency's work to end
the recent Ebola outbreaks in Africa through its international
leadership on the Global Health Security Agenda. GHTC supports the
funding increase to CDC proposed by the administration for FY22 and
urges the Committee to increase funding for CDC's critical global
health R&D work at CGH and NCEZID.
BARDA: BARDA plays an unmatched role in global health R&D by using
unique contracting authorities and targeted incentive mechanisms to
advance the development and purchase of critical medical technologies
for public health emergencies. BARDA partners with diverse stakeholders
from industry, academia, and nonprofits to bridge the valley of death
between basic research and advanced-stage product development for
medical countermeasures--an area where other R&D agencies do not
operate. BARDA has been a critical funder of countermeasures for
naturally occurring health security threats including EIDs such as
COVID-19, Ebola, and Zika, as well as pandemic influenza and
antimicrobial resistance. To date, BARDA's work in advancing tools for
EIDs has largely been funded through emergency supplemental funding. A
dedicated funding line of at least $300 million annually for EID R&D
would ensure that BARDA is resourced to respond quickly to future
threats, rather than wait on haphazard infusions of supplemental
funding during health emergencies.
In addition to bringing lifesaving tools to those who need them
most, investment in global health R&D is also a smart economic
investment in the United States with 89 cents of every US dollar
invested in global health R&D going directly to US-based researchers.
US government investment in global health R&D between 2007 and 2015
generated an estimated 200,000 new jobs and $33 billion in economic
growth. Investments in global health R&D today can help achieve
significant cost-savings in the future--a fact made plain by the
economic devastation of the COVID-19 pandemic.
Now more than ever, Congress must make smart investments. Global
health R&D, which improves the lives of people around the world while
supporting US health security, creating jobs, and spurring economic
growth, is a win-win.
______
Prepared Statement of Harvey Friedman, MD
I am an Infectious Disease physician scientist on faculty at the
Perelman School of Medicine of the University of Pennsylvania. My
research interest is herpes simplex virus. I am working on a vaccine
that uses messenger RNA technology for the herpes vaccine that is like
that applied to COVID 19 messenger RNA vaccines by Pfizer and Moderna.
My research has caught the interest of the public. I have received
thousands of emails from people globally expressing their hope that the
vaccine works. Most of the people are already infected with genital
herpes. Their stories are heart-wrenching! Genital herpes is not a
life-threatening infection; however, for many people, it is a life
altering infection, while for some it leads to life ending decisions.
My laboratory has focused on preventing genital herpes, but we are
now turning our attention to preventing oral herpes (HSV-1) and the
many dreaded complications of both viruses, including fever blisters,
infection of the cornea (eye), infection of the brain (encephalitis),
infection of newborns, genital herpes, increasing susceptibility to HIV
infection, and possibly contributing to dementia.
Medical research is at a point that we have the tools to come up
with vaccines that will prevent genital herpes for those not yet
infected, and approaches to rid the body of the dormant (latent) virus
as a cure for subjects already infected.
Please set a priority to establish a strategic plan and national
strategy for treating and preventing herpes infections, particularly
genital herpes.
Sincerely,
Harvey Friedman, MD, Email: [email protected], Office
address: Infectious Disease Division, 522E Johnson Pavilion, 3610
Hamilton Walk, Philadelphia, PA 19104-6073.
______
Prepared Statement of the Health Professions and Nursing Education
Coalition
The Health Professions and Nursing Education Coalition (HPNEC) is
an alliance of over 90 national organizations representing schools,
students, health professionals, and communities dedicated to ensuring
that the health care workforce is trained to meet the needs of our
diverse population. Together, the members of HPNEC advocate for
adequate and continued support for the health professions and nursing
workforce development programs authorized under Titles VII and VIII of
the Public Health Service Act and administered by the Health Resources
and Services Administration (HRSA). For fiscal year (FY) 2022, HPNEC
encourages the subcommittee to adopt at least $1.51 billion for HRSA
Titles VII and VIII programs.
The HRSA Titles VII and VIII programs are essential to educating
our health care workforce to manage health care crises, such as the
COVID-19 pandemic. The immense challenges of the pandemic have
underscored the need to increase and reshape our health workforce, and
the HRSA Titles VII and VIII programs successfully recruit, train, and
support public health practitioners, nurses, geriatricians, advanced
practice registered nurses, mental health providers, and other
frontline health care workers critical to addressing COVID-19.
Additionally, HRSA tasked Title VII and Title VIII grantees to utilize
innovative models of care, such as training providers in telehealth, to
improve patients' access to care during the pandemic.
The U.S Census Bureau projects that by 2045:
--the US population will grow by over 18%,
--more than half the country will come from a racial or ethnic
minority group, and
--one in five Americans will be over 65.
To prepare for these changing demographics, we urge Congress to
increase funding for the HRSA Title VII and Title VIII programs to
educate current and future providers that serve these ever-growing
needs while preparing for the health care demands of tomorrow.
Diversity Pipeline Programs.--The COVID-19 pandemic has underscored
the pervasive health inequities facing minority communities, as well as
gaps in care for our most vulnerable patients, including an aging
population that requires more health care services. The HRSA Title VII
and Title VIII programs play an essential role in improving the
diversity of the health workforce and connecting students to health
careers by supporting recruitment, education, training, and mentorship
opportunities. Inclusive and diverse education and training experiences
expose providers to backgrounds and perspectives other than their own
and heighten cultural awareness in health care, resulting in benefits
for all patients.
HRSA diversity programs include the Health Careers Opportunity
Program (HCOP), Centers of Excellence (COE), Faculty Loan Repayment,
Nursing Workforce Diversity, and Scholarships for Disadvantaged
Students (SDS). Studies have demonstrated the effectiveness of such
pipeline programs in strengthening students' academic records,
improving test scores, and helping minority and disadvantaged students
pursue careers in the health professions. Title VII diversity pipeline
programs reached over 13,500 students in the 2019-2020 academic year
(AY), with SDS graduating nearly 1,400 students, and COE reaching
nearly 5,000 health professionals, 72% of which were located in
medically underserved communities.
Title VIII's Nursing Workforce Diversity Program increases nursing
education opportunities for individuals from disadvantaged backgrounds
through stipends and scholarships and a variety of pre-entry and
advanced education preparation. In AY 2019-20, the program supported
more than 11,000 students, with approximately 45% of the training sites
located in underserved communities.
Primary Care Workforce.--The Primary Care Medicine Programs expand
the primary care workforce, including general pediatrics, general
internal medicine, family medicine, and physician assistants through
the Primary Care Training and Enhancement (PCTE) and Primary Care
Medicine and Dentistry Career Development programs. The primary care
programs are also intended to encourage health professionals to work in
underserved areas. In AY 2019-20, PCTE grantees trained over 14,000
individuals at over 1,100 sites, with 54% in medically underserved
communities and 26% in rural areas; 30% of sites trained providers in
telehealth services.
The Medical Student Education program, which supports the health
care workforce by expanding training for medical students to become
primary care clinicians, targets higher education institutions in
states with the highest primary care workforce shortages. The program
help develop partnerships among institutions, federally recognized
tribes, and community-based organizations to train medical students to
provide primary care that improves health outcomes for those living in
rural and other underserved communities. In AY 2019-2020, Medical
Student Education grantees trained over 1,100 health professionals, 88%
of which located in primary care settings, 68% in medically underserved
communities, and 66% in rural areas.
Interdisciplinary, Community Based Linkages.--Support for
community-based training of health professionals in rural and urban
underserved areas is funded through Title VII. By assessing the needs
of the local communities they serve, HRSA Title VII programs can fill
gaps in the workforce and increase access to care for all populations.
The programs emphasize interprofessional education and training,
bringing together knowledge and skills across disciplines to provide
effective, efficient, and coordinated care.
Programs such as Graduate Psychology Education (GPE), Opioid
Workforce Enhancement Program, Mental and Behavioral Health, and
Behavioral Health Workforce Education and Training (BHWET) respond to
changing delivery systems and models of care, and timely address
emerging health issues in their communities. The BHWET and Mental and
Behavioral Health programs, provide training to expand access to mental
and behavioral health services for vulnerable and underserved
populations. In AY 2019-20, nearly 50% of all BHWET and GPE grantees
provided substance use disorder treatment services.
Area Health Education Centers (AHEC) support the recruitment and
training of future physicians in rural areas and provide
interdisciplinary health care delivery sites, which respond to
community health needs. In AY 2019-20, AHECs supported 192,000 pipeline
program participants and provided over 34,000 clinical training
rotations for health professions trainees.
Title VII Geriatric Workforce programs integrate geriatrics and
primary care to provide coordinated and comprehensive care for older
adults. These programs offer training across the provider continuum,
focusing on interprofessional and team-based care and academic-
community partnerships to address gaps in health care for older adults.
To advance the training of the current workforce, the Geriatrics
Workforce Enhancement Program (GWEP) provided 2,068 unique continuing
education courses to over 200,000 faculty and practicing professionals
in AY 2019-20, including 906 courses on Alzheimer's and dementia-
related diseases.
Nursing Workforce Development.--HRSA Title VIII nursing workforce
development programs provide federal support to address all aspects of
nursing workforce demands, including education, practice, recruitment,
and retention, focusing on rural and medically underserved communities.
These programs include Advanced Nursing Education; Nursing Workforce
Diversity; Nurse Education, Practice, Quality, and Retention; NURSE
Corps; and Nurse Faculty Loan Program. In AY 2019-2020, the Title VIII
Advanced Education Nursing programs supported more than 8,000 nursing
students in primary care, anesthesia, nurse-midwifery, and other
specialty care, all of whom received clinical training in primary care
in medically underserved communities and/or rural settings.
Oral Health.--The Primary Care Dentistry program invests in
expanding programs in primary dental care for pediatric, public health,
and general dentistry. The Pre- and Postdoctoral Training, Residency
Training, Faculty Development, and Faculty Loan Repayment programs
encourage integrating dentistry into primary care.
Public Health.--Public Health Workforce Development programs
support education and training in public health and preventive medicine
through different initiatives, including the only funding for
physicians to work in state and local health departments. Public health
student trainees partnered with 278 sites in AY 2019-20, with 74% of
these training sites located in medically underserved communities and
29% in primary care settings.
Workforce Information and Analysis.--The Workforce Information and
Analysis program provides funding for the National Center for Health
Workforce Analysis as well as grants to seven Health Workforce Research
Centers across the country that perform and disseminate research and
data analysis on health workforce issues of national importance.
While HPNEC's members acknowledge the competing demands facing
appropriators, funding for HRSA's workforce development programs is
critical to creating a culturally competent workforce that can respond
to future health threats and challenges facing all Americans.
Therefore, HPNEC encourages the subcommittee to provide at least $1.51
billion in the FY 2022 appropriations bill for HRSA's Title VII and
VIII programs to continue the nation's investment in our health
workforce.
______
Prepared Statement of the Hearing Industries Association and the
Hearing Loss Association of America
Dear Chairwoman Murray, Ranking Member Blunt, and Members of the
Subcommittee,
Thank you for the opportunity to submit testimony concerning Fiscal
Year 2022 (FY22) Labor, Health and Human Services, Education and
Related Agencies appropriations. The Hearing Industries Association
(HIA) and the Hearing Loss Association of America (HLAA) are requesting
inclusion of report language to direct the National Institutes of
Health (NIH) Office of the Director to provide an accounting of funds
currently used for hearing screening research and encourage NIH to
prioritize funding for studies that address the research needs and gaps
identified by the U.S. Preventive Services Task Force (USPSTF).
HIA is the national organization of the manufacturers, suppliers
and distributors of hearing aids, implants, assistive listening
devices, component parts and power sources. HIA's mission is to be a
trusted voice on product innovation, patient safety and education, and
public policy. HLAA is the nation's leading organization representing
consumers with hearing loss and seeks to enable people with hearing
loss to live life fully and without compromise. We are pleased to work
together to support the more than 38 million individuals in the United
States with untreated hearing loss,\1\ including one in three people
between the ages of 65 and 74 and over half of those older than 75.
Hearing loss is associated with many comorbidities, including cognitive
decline, dementia, falls, depression, reduced quality of life, and an
increased number of emergency department visits and hospitalizations.
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\1\ ``How Many People Have Hearing Loss in the United States?'',
Johns Hopkins Cochlear Center for Hearing and Public Health, https://
www.jhucochlearcenter.org/how-many-people-have-hearing-loss-unaited-
states.html.
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In March 2021, the USPSTF, a volunteer panel of national experts in
prevention and evidence-based medicine tasked with providing
recommendations regarding preventive screening and services, issued its
final recommendations regarding hearing screening for older adults over
the age of 50. The USPSTF ultimately declined to make a recommendation
in support of hearing screening, finding that ``current evidence is
insufficient to assess the balance of benefits and harms of screening
for hearing loss in older adults.'' \2\ The final recommendation notes
that more research is needed.
---------------------------------------------------------------------------
\2\ https://www.uspreventiveservicestaskforce.org/uspstf/
recommendation/hearing-loss-in-older-adults-screening.
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We understand the gaps in research identified by the USPSTF's
recommendations and agree that additional research to support a
universal hearing screening recommendation for older adults is needed.
Given the significant associated comorbidities of hearing loss
discussed below, we also believe this research should be prioritized.
Therefore, we urge this Subcommittee to support inclusion of report
language to convey the importance of building the research base for
older adult hearing screening, as follows:
Hearing Health Screening. The Committee recognizes the associated
comorbidities and costs of untreated hearing loss and, with the growing
aging population, the importance of hearing screening for older
Americans. The Committee directs the National Institutes of Health
(NIH) Office of the Director to provide an accounting of all funds used
for hearing screening research across all Institutes within 90 days of
enactment of this Act. The Committee encourages NIH to prioritize
funding through the Office of the Director and engage appropriate
Institutes like the National Institute on Deafness and Other
Communication Disorders (NIDCD) and National Institute on Aging (NIA)
for studies that address the research needs and gaps identified by the
U.S. Preventive Services Task Force (USPSTF). These research needs may
include gaps identified in USPSTF review of hearing screening
recommendations for older Americans.
Earlier diagnosis of hearing loss and appropriate intervention are
crucial to avoiding the negative social, emotional, and health
consequences of hearing loss. Age-related hearing loss is the third
leading cause of chronic disability in older adults and has shown to be
associated with predisposing cognitive impairment and dementia.\3\
According to the Lancet Commission, as of 2020, there are twelve
behaviorally modifiable risk factors associated with dementia
prevention, accounting for approximately 40 percent of dementias
globally. Of note, hearing impairment accounts for approximately nine
percent of the modifiable risk and the Lancet Commission recommends
reducing noise-related hearing loss and treating hearing loss with the
use of hearing aids.\4\ Additionally, a recent study found that mild
hearing loss doubled the risk of dementia, moderate loss tripled risk,
and those with severe hearing impairment were five times more likely to
develop dementia.\5\ Emerging evidence indicates that hearing
interventions can delay the onset or reduce the rate of cognitive
decline.\6,7\ Additional studies, including the Aging and Cognitive
Health Evaluation in Elders (ACHIEVE) study,\8\ are expected to further
address the role and efficacy of hearing treatment in reducing
cognitive decline in older adults.
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\3\ Jafari Z, Kolb BE, Mohajerani MH. Age-Related Hearing Loss and
Tinnitus, Dementia Risk, and Auditory Amplification Outcomes. Ageing
research reviews. 2019:100963.
\4\ Livingston G, Huntley J, Sommerland A, et al. Dementia
prevention, intervention, and care: 2020 report of the Lancet
Commission. Lancet. 20202 [Aug 8]; 396 (10248); 413-446.
\5\ ``The Hidden Risks of Hearing Loss'', Johns Hopkins Medicine,
https://www.hopkinsmedicine.org/health/wellness-and-prevention/the-
hidden-risks-of-hearing-loss.
\6\ Maharani A, Dawes P, Nazroo J, Tampubolon G, Pendleton N, on
behalf of the SENSE-Cog WP1 group. Am Geriatr Soc. 2018;66(6):1130-
1136. https://agsjournals.onlinelibrary.wiley.com/doi/abs/10.1111/
jgs.15363.
\7\ Sarant J, Harris D, Busby P, Maruff P, Schembri A, Lemke U, &
Launer S (2020). The Effect of Hearing Aid Use on Cognition in Older
Adults: Can We Dely Decline or Even Improve Cognitive Function? Journal
of Clinical Medicine, 9(1), 254.
\8\ https://clinicaltrials.gov/ct2/show/NCT03243422.
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As hearing loss progresses, it manifests via profound consequences
on verbal communication and social, functional, and psychological
wellbeing of the person. The National Institutes of Health (NIH) has
found that over 78 percent of participants with insufficient or poor
hearing suffered from at least one additional chronic condition,
leading to increased health care costs in any given year.\9\ For adults
over 60 years of age, untreated hearing loss is associated with
approximately 46 percent higher total health care costs over a 10-year
period compared with costs for those without hearing loss.\10\ People
with even a mild hearing loss are also three times more likely to fall,
compared to individuals with normal hearing.\11\ When hearing loss does
occur, early diagnosis and intervention are crucial for avoiding the
negative social, emotional, and health consequences already described.
---------------------------------------------------------------------------
\9\ Maharani A, Dawes P, Nazroo J, Tampubolon G, Pendleton N, on
behalf of the SENSE-Cog WP1 group. Am Geriatr Soc. 2018;66(6):1130-
1136. https://agsjournals.onlinelibrary.wiley.com/doi/abs/10.1111/
jgs.15363.
\10\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6439810/.
\11\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3518403/.
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There is evidence that rates of hearing loss begin to rise around
the age of 50, but the prevalence of hearing loss dramatically
increases as an individual grows older (Figure 1).\12\ Individuals may
underestimate their hearing difficulty and fail to pursue potentially
beneficial treatment for their hearing loss that could lead to better
health outcomes. Thus, hearing screening should be a part of every
wellness check or physical exam for older adults, the population most
at risk of age-related hearing loss.
---------------------------------------------------------------------------
\12\ Jorgensen, L. & Novak, M. (2020). Factors Influencing Hearing
Aid Adoption. Seminars in Hearing, 41(1), 7. https://doi.org/10.1055/s-
0040-1701242.
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Figure1.
As the Subcommittee develops its FY22 Labor-HHS-Education
appropriations bill and accompanying report language, we respectfully
request your support for the millions of Americans suffering from
hearing loss by encouraging NIH to pursue hearing screening research.
Hearing health is essential and hearing screening is the first step. We
look forward to working with you and appreciate your attention to this
important issue.
[This statement was submitted by Kate Carr, President, Hearing
Industries
Association, and Barbara Kelley, Executive Director, Hearing Loss
Association of America.]
______
Prepared Statement of the Hepatitis B Foundation
hepatitis b foundation recommendations for fiscal year 2021
appropriations
_______________________________________________________________________
National Institutes of Health
--Along with the biomedical research community, the Hepatitis B
Foundation (HBF) supports the President's request for $51
billion for the National Institutes of Health. While we are
anxious to see the details of the President's request,
specifically the details of the proposed ARPA-H initiative, we
appreciate President Biden's commitment to allowing for
meaningful growth in the base budget and expanding NIH's
capacity to support promising science in all disciplines.
--HBF commends NIAID, NIDDK, NCI for the development of a Trans-NIH
Strategic Plan to Cure Hepatitis B and urges the Institutes to
issue targeted calls for research to implement and fund the
Strategic Plan.
Centers for Disease Control and Prevention
--HBF supports $10 billion for the Centers for Disease Control and
Prevention programs in FY 2021, and within that $134 million
for the Division of Viral Hepatitis. HBF further urges the CDC
to allocate the necessary resources to address serious
surveillance shortcoming without adversely impacting other CDC
hepatitis B programs.
--HBF urges the Division of Viral Hepatitis to fund both the
Hepatitis B and the Hepatitis C community infrastructure grants
in order to maintain and grow progress to address the public
health threats of both hepatitis B and hepatitis C.
HHS Office of the Secretary
--HBF supports the newly released Viral Hepatitis National Strategic
Plan and urges the establishment of an office or initiative to
lead this elimination strategy and the provision of adequate
staff and other resources needed for success.
_______________________________________________________________________
Mrs. Chairwoman and Members of the Subcommittee, thank you for the
opportunity to provide testimony as you consider funding priorities for
Fiscal Year (FY) 2022. I am Tim Block, President of the Hepatitis B
Foundation (HBF). The Hepatitis B Foundation and its associated Baruch
S. Blumberg Institute in Bucks County, Pennsylvania has grown to more
than 100 researchers and public health professionals and has one of the
largest, if not the largest, concentration of nonprofit scientists
working on the problem of hepatitis B and liver cancer in the United
States. The Foundation is a national disease advocacy organization that
has become the world's leading portal for patient-focused information
about hepatitis B. The Baruch S. Blumberg Institute is internationally
recognized, and we believe, home to some of the most exciting and
promising work in the field.
Mrs. Chairwoman, HBF strongly supports the President's $51 billion
request for NIH funding in FY 2022. HBF further urges that NIH increase
investments in hepatitis B research in order to find a cure for the 2.4
million Americans infected with the hepatitis B virus (HBV) and more
than 10 deaths each day as a direct result of hepatitis B.
In addition to the NIH, there are a number of programs within the
jurisdiction of the subcommittee that are important to HBF, including
the Centers for Disease Control and Prevention. We join the CDC
Coalition, an advocacy coalition of more than 140 national
organizations, in recommending $10 billion for the Centers for Disease
Control and Prevention in the FY 2022 bill. Within that total, we join
the Hepatitis Appropriations Partnership in urging $134 million for the
CDC's Division of Viral Hepatitis.
Finally, we would urge that the newly released Viral Hepatitis
National Strategic Plan be led and funded fully as necessary to move us
toward the goal of the elimination of viral hepatitis in the United
States.
recognizing the leadership of the subcommittee
Mrs. Chairwoman, HBF appreciates your leadership and the leadership
of this Subcommittee in supporting public health service programs. Your
support is greatly recognized and appreciated. We applaud the
Committee's leadership in making progress in these important areas and
to allocating increased funding to these programs during periods of
fiscal austerity.
national institutes of health
As previously noted, HBF supports the President's request for $51
billion for the NIH. We look forward to learning more about the
proposed ARPA-H initiative to accelerate the implementation of research
findings. While we appreciate the President's bold vision to promote
transformational innovations against the range of diseases facing
humankind, we want to be sure that new investments are not made at the
expense of the important basic science that is critical to our
scientific enterprise. In addition to overall funding for the NIH, HBF
urges that NIH investments in hepatitis B research be increased at
least $38.7 million a year for 6 years to fund identified research
opportunities that would help cure and eliminate the disease once and
for all. The Hepatitis B Foundation appreciated the creation of the
Hepatitis B Trans-NIH Working Group and was even more encouraged by the
release of a Strategic Plan for Trans-NIH Research to Cure Hepatitis B
in December of 2019. Report language is requested in the FY 2022 Report
urging the NIAID and NIDDK to issue targeted calls for hepatitis B
research proposals in FY 2022 focused on the many new research
opportunities identified by the Strategic Plan.
In the U.S., an estimated 2.4 million are chronically infected with
hepatitis B virus (HBV). Worldwide, HBV is associated with 840,000
deaths each year, making it the 10th leading cause of death in the
world. Left undiagnosed and untreated, 1 in 4 of those with chronic HBV
infection will die prematurely from cirrhosis, liver failure and/or
liver cancer. Although HBV is preventable and treatable, there is still
no cure for this disease. In view of the epidemic scope of hepatitis B
and the fact that the virus was discovered 50 years ago, it is
disappointing that funding for HBV research at the NIH is only expected
to be funded at $66 million in FY 2021.
There is the need, the know- how, and the tools to find a cure that
will bring hope to almost 300 million people worldwide suffering from
chronic hepatitis B. A cure was accomplished for hepatitis C with
increased federal attention and funding. It can be accomplished for
hepatitis B as well. Each year, despite an effective vaccine, 3-7
million people worldwide are infected, and the epidemic continues to
grow. Moreover, despite the availability of seven approved medications
to manage chronic HBV infection, none are curative, most require
lifelong use, and only reduce the likelihood of developing liver cancer
by 40-60%.
In addition to the devastating toll on patients and their families,
ignoring hepatitis B is costing the United States an estimated $4
billion per year in medical costs. By increasing the NIH budget for
hepatitis B we have a good chance of success in finding a cure in the
next few years. There are exciting new research developments and
opportunities in the field that make finding a cure very possible.
Centers for Disease Control and Prevention
Given the challenges and burdens of chronic disease and disability,
public health emergencies, new and reemerging infectious diseases and
other unmet public health needs, HBF joins the 140 organizations in the
CDC Coalition and urges a funding level of at least $10 billion for
CDC's programs in FY 2022. This is $1.3 billion more than the
Administration's request. The CDC serves as the command center for the
nation's public health defense system against emerging and reemerging
infectious diseases. States, communities, and the international
community rely on CDC for accurate information and direction in a
crisis or outbreak. While recent emergency funding has supported
efforts to defeat COVID-19, we must provide stable, sufficient public
health preparedness funding to allow our state and local health
departments to maintain a standing set of core capabilities, so they
are ready when needed, regardless of the next challenge or threat.
The CDC's Division of Viral Hepatitis (DVH) is part of the National
Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)
at CDC. In collaboration with domestic and global partners, DVH
provides the scientific and programmatic foundation and leadership for
the prevention and control of hepatitis virus infections and their
manifestations. HBF joins the Hepatitis Appropriations Partnership in
recommending $134 million for the DVH in FY 2022 and within this level
urges the Division to fund both the Hepatitis B and Hepatitis C
community infrastructure grants. To discontinue one of these grants
would be a step backward in the progress being made.
The CDC Division of Viral Hepatitis spends less than 10% of its
budget on HBV focused projects, despite hepatitis B infected patients
comprising more than 35% of all those infected with viral hepatitis in
the U.S. Furthermore, tremendous HBV-related health disparities exist
for Asian Americans and Pacific Islanders and recent African
immigrants. These groups represent less than 6% of the U.S. population
but make up 50%-80% of the U.S. burden of chronic HBV infection. CDC
has not adequately addressed the issue of chronic HBV infections among
high-risk, foreign-born populations and their children. Of particular
concern is that the CDC surveillance program is not robust enough to
accurately report the prevalence of hepatitis B in high incidence
states such as California and Hawaii. In view of the fundamental
importance of good surveillance data to develop, manage and analyze
public health programs and interventions, HBF urges CDC to allocate the
necessary resources to address this shortcoming without adversely
impacting other CDC hepatitis B programs.
HBF is further concerned that despite the availability of an
effective hepatitis B (HBV) vaccine, less than 25% of adults age 19 and
older are vaccinated. According to CDC's most recent survey of
Vaccination Coverage Among Adults, this poor vaccination rate remains
flat and has not improved in several years. We are encouraged that CDC
is evaluating new universal HBV vaccination recommendations including a
comprehensive plan to increase adult HBV vaccinations. The CDC is
further urged to promote awareness about the importance of hepatitis B
vaccination among medical and health professionals, communities at high
risk, and the public, and to improve collaboration and coordination
across CDC to achieve this goal.
summary and conclusion
Mrs. Chairwoman, again we wish to thank the Subcommittee for its
past leadership. Significant progress has been made in meeting the many
public health concerns facing this Nation, due to your efforts. HBF
appreciates the opportunity to provide testimony to you on behalf of
these paramount needs of the Nation.
[This statement was submitted by Timothy Block, Ph.D., President,
Hepatitis B Foundation.]
______
Prepared Statement of the HIV Medicine Association
Chairwoman Murray, Ranking Member Blunt, and members of the
Subcommittee, my name is Dr. Marwan Haddad, MD, MPH, Chair-elect of the
HIV Medicine Association (HIVMA), and I serve as the Medical Director
of the Center for Key Populations at the Community Health Center, Inc.
(CHCI), in Middletown, Connecticut, one of the largest Federally
Qualified Health Center in the country. I am pleased to submit
testimony on behalf of HIVMA. HIVMA represents nearly 5,000 physicians,
scientists, and other health care professionals around the country on
the frontlines of the HIV epidemic. Our members provide care and
treatment to people with HIV, lead HIV prevention programs, and conduct
research in communities across the country. Many of them have been on
the frontlines of their community's coronavirus (COVID-19) response.
For the FY2022 appropriations process, we urge you to increase
funding for the Ryan White HIV/AIDS Program at the Health Resources and
Services and Administration (HRSA); increase funding for the Centers
for Disease Control and Prevention's (CDC) HIV, hepatitis, and STD
prevention programs; increase investments in HIV research supported by
the National Institutes of Health (NIH); appropriate additional funding
to support the ``Ending the HIV Epidemic'' (EHE) Initiative; and the
implementation of the EHE initiative as well as the response to the
COVID-19 pandemic. As the United States responds to the global COVID-19
pandemic, it is paramount to provide robust funding for public health,
including these vital programs which support global and domestic health
security measures and our public health infrastructure.
The funding requests in our testimony largely reflect the consensus
of the Federal AIDS Policy Partnership, a coalition of HIV
organizations from across the country. For a chart of current and
historical funding levels, along with coalition requests for each
program, please click here.
ending the hiv epidemic initiative--u.s. department of
health and human services
Over the last two years, on a bipartisan basis, Congress has
appropriated funding for the EHE Initiative, which sets the goal of
reducing new HIV infections by 50% by 2025, and 90% by 2030. We
recommend funding the EHE initiative at least at the President's budget
request for $670 million in support of ending HIV as an epidemic to be
used for expanded access to antiretroviral treatment and PrEP to
prevent HIV transmissions as well as improved access to routine and
critical health services.
health resources and services administration--hiv/aids bureau
HRSA's Ryan White HIV/AIDS Program provides medical care and
treatment services to over half a million people living with HIV. Over
three-quarters of Ryan White clients are Black, Latinx or other people
of color, and nearly two-thirds have incomes under the federal poverty
level. To continue providing comprehensive, life-saving treatment and
to bring many more people into care through the EHE Initiative, we urge
Congress to fund the Ryan White HIV/AIDS Program at a total of $2.768
billion in FY2022, an increase of $345 million over FY2021. We strongly
recommend providing at least $222 million in EHE funding for the Ryan
White Program.
HIVMA urges an allocation of $225.1 million, or a $24 million
increase over current funding, for Ryan White Part C programs. The
flexibility of the Ryan White Program and its providers' expertise has
also allowed Part C clinics to respond to the changing needs of
patients and the health care system throughout the COVID-19 pandemic.
Ryan White clinics serve a significant number of individuals living
with both substance use disorder and HIV, delivering a range of medical
and support services, including overdose prevention and harm reduction
services, needed to prevent, intervene, and treat substance use
disorder as well as related infectious diseases, including HIV, HCV,
and sexually-transmitted infections (STI).
CHCI's Ryan White-Funded Clinic in Connecticut is Leading on Expanding
Access to HIV Prevention, Care, & Treatment
CHCI's Center for Key Populations, Ryan White-funded Early
Intervention Services Program, has served as the leading source of HIV
primary care in Connecticut for 22 years. Each year our Ryan White
program serves more patients from almost every city and town across
Connecticut.
The needs of both established and newly diagnosed patients with HIV
are growing more complex. In 2020, even as HIV care was innovatively
transformed to mostly telehealth due to COVID-19, CHCI experienced an
increase in the number of patients living with HIV who accessed
services at our sites. Of all new patients enrolled in care at CHCI in
2020, 69% self-reported as racial and ethnic minorities and 56%
reported food and housing insecurity as major barriers to achieving
optimal healthcare. Additionally, 4% of all Ryan White patients were
uninsured, 87.9% had at least one clinical co-morbidity, and 62%
reported unmet mental health needs at the time of intake. Among Ryan
White Program patients at CHCI, 12% reported unstable housing, which
means they were living in a shelter, vehicle, or completely
unsheltered, creating additional challenges to retention in care.
CHCI's Ryan White Program eligible patients who are engaged in care
are screened for substance use disorders routinely and 63% screened
positive with 11% considering those needs urgent or severe. CHCI, like
most Ryan White Part C programs, also receives funding from other parts
of the Ryan White Program, and these help us provide support services
that were particularly important during the COVID-19 pandemic. These
services included home medical monitoring equipment, transportation,
case management, patient navigation, home-delivered meals, grocery
delivery, check-in phone calls, and other key components of care unique
to the Ryan White Program care model and contribute to optimal
healthcare outcomes for all patients.
health resources and services administration--bureau of
primary health care
We recommend appropriating $152 million in new funding for HRSA's
Community Health Center program for the EHE initiative. In those
community health centers funded by the EHE Initiative, they were able
to increase PrEP uptake from 19,000 in 2020 to nearly 50,000 people in
early 2021. CDC estimates only 10% of those who could benefit from PrEP
have had it prescribed to them, and those who need it most--black and
Latino gay and bisexual men at high risk--are prescribed it at a much
lower rate. Scaling up PrEP among the most affected populations is
critical to reducing health disparities and ending HIV as an epidemic.
centers for disease control and prevention--national center for hiv/
aids, viral hepatitis, sexually transmitted diseases, and tuberculosis
prevention
From the CDC's leadership role in responding to the COVID-19
pandemic to its ongoing efforts to address persistent public health
epidemics and threats, such as HIV, STIs, and viral hepatitis, the CDC
is a critical national and global expert resource and response center.
To meaningfully address these epidemics and the co-occurring crisis of
substance use disorder--especially injection drug use--we request a
$731 million overall increase above FY2021 levels for a total of $2.045
billion.
For the Division of HIV/AIDS Prevention (DHAP), we request a total
of $1.293 billion, which is a $328 million increase over FY2021 levels.
DHAP conducts our national HIV surveillance and funds state and local
health departments and communities to conduct evidence-based HIV
prevention activities. CDC's national surveillance system is critical
to monitoring populations and regions impacted by the HIV epidemic and
identifying outbreaks. We also strongly recommend appropriating at
least the $371 million requested by the Administration for the EHE
initiative, allowing the CDC to scale up HIV testing to ensure early
diagnosis and care linkage and PrEP programs to prevent new infections.
Additionally, we urge the appropriation of $120 million for the CDC
to fund surveillance and programming to monitor and prevent opioid-
related infectious diseases as well as expand access to syringe
services programs, harm reduction, and overdose prevention. Funding for
CDC's Infectious Diseases and Opioid Epidemic programming is critical
to respond to increases in serious infections linked to substance use,
including HIV, hepatitis B and C, and life-threatening bacterial
infections such as endocarditis.
For the Division of Viral Hepatitis (DVH), we request a total of
$134 million, which is a $94.5 million increase over FY2021 levels. We
have the tools to prevent this growing epidemic, but increased funding
is urgently needed to expand testing and screening, prevention, and
surveillance to put the U.S. on the path to eliminate hepatitis as a
public health threat.
For the Division of STD Prevention (DSTDP), we request a total of
$272.9 million, which is a $111.1 million increase over FY2021 levels.
For the sixth year in a row, the CDC reports dramatic increases in STIs
in the U.S. These historic increases have created a public health
emergency with devastating long-term health consequences, including
infertility, cancer, HIV transmission, and infant and newborn deaths.
national institutes of health--office of aids research
In order to advance discoveries important to end HIV epidemic as an
epidemic, including improved HIV prevention modalities and treatment
options and ultimately a cure and a vaccine, we ask that at least
$3.854 billion be allocated for HIV research in FY2022, an increase of
$755 million over FY2021. The return on investment in HIV research
extends beyond HIV and includes contributing to the record-breaking
timelines for the development of COVID-19 vaccines.
indian health service--eliminating hiv and hepatitis c in indian
country
Between 2011 and 2015, there was a 38% increase in new HIV
diagnoses among the American Indian/Alaska Native population overall,
and a rise of 58% among AI/AN gay and bisexual men. We urge for the
Indian Health Service component of the EHE Initiative to be funded at
$27 million.
conclusion
The COVID-19 pandemic highlights the importance of preparing for
infectious diseases outbreaks by fully funding programs that support
public health services, infrastructure and workforce so that we are
better prepared for the next pandemic. Thank you for your time and
consideration of these important requests and for strengthening our
nation's ability to end the HIV epidemic in the U.S. Please contact me
or HIVMA's Senior Policy & Advocacy Manager, Jose A. Rodriguez, at
[email protected], if you have any questions or need additional
information. HIVMA is located at 4040 Wilson Boulevard Suite 300,
Arlington, VA 22203.
[This statement was submitted by Marwan Haddad, MD, Chair-elect,
HIV
Medicine Association, MPH.]
______
Prepared Statement of the HIV+Hepatitis Policy Institute
On behalf of the HIV+Hepatitis Policy Institute, we respectfully
submit this testimony in support of increased funding for domestic HIV
and hepatitis programs in the FY 2022 Labor, HHS spending bill. The
HIV+Hepatitis Policy Institute is a leading HIV and hepatitis policy
organization promoting quality and affordable healthcare for people
living with or at risk of HIV, hepatitis, and other serious and chronic
health conditions.
This June 5th our nation commemorated the 40th anniversary of AIDS.
Over the last four decades the U.S. has made great advances in HIV
prevention, care, and treatment; but much work remains. While between
2015 and 2019 the U.S. saw slight decreases in the number of new HIV
infections, disparities continue to exist, and some populations saw
increases in infections. HIV continues to disproportionately impact
Black and Latino gay men, Black women, people who inject drugs, and who
live in the South. The Centers for Disease Control and Prevention (CDC)
reports that over half of all new HIV infections in 2019 were in the
South. Recently, the Department of Health and Human Services released
updated strategic plans to guide our nation in responding to the HIV
and hepatitis epidemics, including for the first time ever calling for
the elimination of viral hepatitis. In each of the plans, the need to
address the syndemics of HIV and hepatitis is prioritized.
As our country continues to respond and recover from the COVID-19
pandemic, which has impacted HIV and hepatitis services, we know we
have the science to end two other infectious diseases that have been
impacting our country for decades: HIV and hepatitis C. While there
still is no cure or vaccine for HIV, we have preventive tools along
with treatments that suppress the virus, and together can bring the
number of new infections down to a point that we can end HIV. For
hepatitis C, there are curative treatments. However, federal leadership
and funding for our public health system is necessary to ramp up
efforts to address these two epidemics. The programs and funding
increases detailed below are pivotal to our nation's ability to end
both HIV and hepatitis.
ending the hiv epidemic in the u.s.
Over the past two years, Congress has appropriated over $400
million in new funding for the Ending the HIV Epidemic in the U.S.
initiative, which sets the goal of reducing new HIV infections by 75
percent by 2025, and 90 percent by 2030. Priority jurisdictions have
used initial funding to develop ending HIV plans with the help of
community partners that build on existing HIV programs and utilize new
innovations and strategies. Even while battling COVID, the Ryan White
HIV/AIDS Program reports that in these priority jurisdictions, with the
additional funding, they were able to bring nearly 6,300 new clients
into the program and re-engage an additional 3,600 between March and
August of 2020. In the community health centers funded by the EHE
initiative, they were able to increase pre-exposure prophylaxis (PrEP)
uptake from 19,000 in 2020 to nearly 63,000 people within 11 months.
We are pleased that President Biden has proposed to increase
funding for the Ending the HIV Epidemic initiative by $267 million as
part of his FY22 budget. Additionally, the Biden administration has
proposed increases in other domestic HIV programs. Since many of these
increases fall short of what was proposed last year and what is needed,
we urge the Congress to do better and significantly increase funding
for the Ending the HIV Epidemic in the U.S. initiative for FY2022 so
that this important work can be properly ramped up. In particular we
ask for increased funding for the following programs:
--CDC Division of HIV/AIDS Prevention for testing, linkage to care,
and prevention services, including PrEP (+$196 m);
--HRSA Ryan White HIV/AIDS Program to expand comprehensive treatment
for people living with HIV (+$107 m); and
--HRSA Community Health Centers to increase clinical access to
prevention services, particularly PrEP (+$50 m)
The success of the EHE initiative rests upon our underlying public
health prevention, care, and treatment programs at the CDC and HRSA.
Congress must ensure that these are adequately funded to provide
services in all areas of the country.
The Ryan White HIV/AIDS Program at the Health Resources and
Services Administration provides medical care, medications, and
essential coverage completion services to over 567,000 low-income,
uninsured, and/or underinsured individuals with HIV. For over 30 years,
the Ryan White program has pioneered innovative models of care which
has resulted in 88 percent of Ryan White clients achieving viral
suppression, a critical marker for decreasing new infections in the
U.S. Currently Ryan White Programs, and particularly the AIDS Drug
Assistance Programs (ADAPs), are facing increased demand as people have
lost health coverage and incomes due to the economic impact of COVID-
19, and state and local budgets have become increasingly stressed.
Without increased funding some ADAPs may be forced to institute wait
lists for medications or other cost containment measures. We urge
Congress to fund the Ryan White HIV/AIDS Program at a total of $2.768
billion in FY2022, an increase of $345 million over FY2021 including an
increase of $68 million for ADAPs for total funding of $968.3 million.
In addition, HIV+Hep opposes any efforts through the appropriations
process to alter the intent of the program to use Ryan White-derived
funds for activities outside the scope of the original intent of
current legislative language.
The CDC Division of HIV Prevention funds state and local public
health departments and community-based organizations to implement and
enhance targeted, tailored, and high-impact prevention programs aimed
at addressing racial and geographic health disparities. This includes
HIV testing, condom distribution programs, and other HIV awareness
campaigns. CDC also funds our national surveillance system which is
critical to identifying new HIV clusters and outbreaks and provides the
data necessary to tailor resources and programming. Funding from the
CDC also allows communities to focus on increasing access to and use of
PrEP, which is critical to ending the HIV epidemic. Recent CDC data
show that in 2019, nearly 285,000 or 23 percent of people eligible for
PrEP were prescribed it, up from 3 percent in 2015. While this increase
is moving in the right direction, some of the communities most in need
of PrEP are not receiving it and we must continue building programs to
provide outreach to communities and education about PrEP.
A holistic response to the HIV epidemic also depends on fully
funding other priority programs at HHS, including the CDC's Division of
School and Adolescent Health and STI Prevention, the Minority HIV/AIDS
Initiative, AIDS Research at the NIH, the Title X Family Planning
Program, and the Teen Pregnancy Prevention Program (TPPP).
viral hepatitis
We respectfully request that you provide increased funding for
viral hepatitis programs at the CDC. The CDC estimates that more than
4.5 million people in the United States live with hepatitis B (HBV) or
hepatitis C (HCV), with nearly half unaware they are living with the
disease. The opioid epidemic has significantly increased the number of
viral hepatitis cases in the United States, with available data
suggesting that more than 70 percent of new HCV infections are among
people who inject drugs. There are several curative treatments
available for HCV, but individuals must have access to screening and
linkage to care programs to be able to take advantage of these
medications. The number of acute hepatitis C cases reported in the U.S.
has increased every year since 2012. CDC recently reported an increase
of 63 percent in acute hepatitis C cases between 2015 and 2019, with 67
percent of the cases in 2019 associated with injection drug use.
CDC Division of Viral Hepatitis
The viral hepatitis programs at the CDC are severely underfunded,
receiving only $39.5 million-far short of what is needed to build and
strengthen our public health response and to eventually end hepatitis.
States' ability to conduct enhanced HCV surveillance activities is
severely hampered by a lack of funding. Additional resources would
allow the CDC to enhance testing and screening programs, link people to
treatment, conduct additional provider education, and increase services
related to hepatitis outbreaks and injection drug use. We urge you to
provide the CDC Division of Viral Hepatitis with $134 million, an
increase of $94.5 million over FY 2021 enacted levels.
CDC's Eliminating Opioid-Related Infectious Diseases Program
This CDC program focuses on addressing the infectious disease
consequences of increased rates of injection drug use due to the opioid
crisis. Providing full support for this program is another key step in
preventing new cases of viral hepatitis and HIV and putting the country
on the path towards elimination. We urge the committee to fund this
program to eliminate opioid-related infectious diseases at no less than
$120 million, an increase of $107 million.
syringe service programs (ssps)
We also ask that the committee support ending any prohibition on
the use of federal funds to purchase sterile needles or syringes for
SSPs. A wealth of scientific evidence has shown that SSPs reduce the
spread of infectious diseases, such as HIV and hepatitis. Full federal
funding for these programs will only serve to make the programs
stronger and more effective.
In conclusion, we urge the committee to continue its investment in
our nation's public health infrastructure specifically as it relates to
addressing the ongoing HIV and HCV epidemics. Fortunately, we have the
tools available to end both these epidemics; however, we must provide
the necessary resources to achieve these goals.
[This statement was submitted by Carl Schmid, Executive Director,
HIV+Hepatitis Policy Institute.]
______
Prepared Statement of the Human Factors and Ergonomics Society
On behalf of the Human Factors and Ergonomics Society (HFES), we
are pleased to provide this written testimony to the Senate
Subcommittee on Labor, Health and Human Services, Education, and
Related Agencies for the official record. HFES urges the Subcommittee
to provide no less than $500 million for the Agency for Healthcare
Research and Quality (AHRQ) and a minimum of $375.3 million for the
National Institute for Occupational Safety and Health (NIOSH),
including $34 million for the Education and Research Centers (ERCs), in
fiscal year (FY) 2022.
AHRQ supports research to improve health care quality, reduce
costs, advance patient safety, decrease medical errors, and broaden
access to essential services. As the lead federal agency for funding
health services research (HSR) and primary care research (PCR), AHRQ is
the bridge between cures and care, and ensures that Americans get the
best health care at the best value. The RAND Corporation released a
report in 2020 as called for by the Consolidated Appropriations Act of
2018, which identified AHRQ as ``the only agency that has statutory
authorizations to generate HSR and be the home for federal PCR, and the
unique focus of its research portfolio on systems-based outcomes (e.g.,
making health care safer, higher quality, more accessible, equitable,
and affordable) and approaches to implementing improvement across
health care settings and populations in the United States.''
HFES requests a minimum of $500 million for AHRQ, which is
consistent with the FY 2010 level adjusted for inflation and reflects
the demonstrated needs of pandemic response. This funding level will
allow AHRQ to rebuild portfolios terminated after years of cuts. AHRQ
is the federal vehicle for studying and improving the United States
healthcare system, and it needs the resources to meet its mission and
this moment. Through this appropriation level, AHRQ will be better able
to fund the ``last mile'' of research from cure to care.
Additionally, HFES requests $375.3 million for NIOSH, including $34
million for the Education and Research Centers (ERCs). NIOSH supports
education and research in occupational health through academic degree
programs and research opportunities. With an aging occupational safety
and health workforce, ERCs are essential for training the next
generation of professionals. The Centers establish academic, labor, and
industry research partnerships to achieve these goals. Currently, ERCs
are responsible for supplying many of the country's OSH graduates who
will go on to fill professional roles.
HFES strongly believes that investment in scientific research
serves as an important driver for innovation and the economy as well as
for protecting and promoting the health, safety, and well-being of
Americans. We thank the Subcommittee for its longtime recognition of
the value of scientific and engineering research and its contribution
to innovation and public health in the U.S.
the value of human factors and ergonomics science
HFES is a multidisciplinary professional association with over
3,000 individual members worldwide, including psychologists and other
scientists, engineers, and designers, all with a common interest in
designing safe and effective systems and equipment that maximize and
adapt to human capabilities.
For over 50 years, the U.S. federal government has funded
scientists and engineers to explore and better understand the
relationship between humans, technology, and the environment.
Originally stemming from urgent needs to improve the performance of
humans using complex systems such as aircraft during World War II, the
field of human factors and ergonomics (HF/E) works to develop safe,
effective, and practical human use of technology. HF/E does this by
developing scientific approaches for understanding this complex
interface, also known as ``human-systems integration.'' Today, HF/E is
applied to fields as diverse as transportation, architecture,
environmental design, consumer products, electronics and computers,
energy systems, medical devices, manufacturing, office automation,
organizational design and management, aging, farming, health, sports
and recreation, oil field operations, mining, forensics, and education.
With increasing reliance by federal agencies and the private sector
on technology-aided decision-making, HF/E is vital to effectively
achieving our national objectives. While a large proportion of HF/E
research exists at the intersection of science and practice--that is,
HF/E is often viewed more at the ``applied'' end of the science
continuum--the field also contributes to advancing ``fundamental''
scientific understanding of the interface between human decision-
making, engineering, design, technology, and the world around us. The
reach of HF/E is profound, touching nearly all aspects of human life
from the health care sector to the ways we travel and to the hand-held
devices we use every day.
conclusion
HFES urges the Subcommittee to provide $500 million for AHRQ and
$375.3 million for NIOSH, including $34 million for the Education and
Research Centers (ERCs) in FY 2022. These investments fund important
research studies, enabling an evidence base, methodology, and
measurements for improving healthcare, safety, and public health for
Americans.
On behalf of the HFES, we would like to thank you for the
opportunity to provide this testimony. Please do not hesitate to
contact us should you have any questions about HFES or HF/E research.
HFES truly appreciates the Subcommittee's long history of support for
scientific research and innovation.
[This statement was submitted by Peter Hancock, DSc, PhD,
President, and
Steven C. Kemp, CAE, Executive Director, Human Factors and Ergonomics
Society.]
______
Prepared Statement of I AM ALS
Chairwoman Murray, Ranking Member Blunt thank you for the
opportunity to submit written testimony. My name is Brian Wallach and I
have enjoyed the opportunity to work with both of you and your
colleagues in the Senate ALS Caucus over the past several years.
I am grateful for all you and your colleagues have done for the ALS
community. Thanks to you and others like Senators Dick Durbin, Lisa
Murkowski, Chris Coons, and Mike Braun, and our incredible ALS
grassroots advocates, we have increased federal spending on ALS
research by $83 million in just two years. And this past December,
Congress overwhelmingly passed a bill to give ALS patients access to
SSDI benefits upon diagnosis, averting bankruptcy for so many.
As a result of this work, the path towards ending ALS is clearer.
The question now is when do we reach the end of that path and will any
of those of us living with ALS now be here to see that day?
I desperately want to be here, but my body is failing. You can hear
it in my voice and see it in the videos I post on Twitter. Odds are
that unless something changes, I won't be. The average patient lives 2-
5 years post-diagnosis and of those diagnosed in 2017 with me, four out
of five-80%-are dead.
So I come with two urgent asks. Ones that if you make real will
change my and millions of others' futures.
First, fund ARPA-H and include ALS among its core disease areas.
During the 2020 campaign then-candidate Joe Biden promised ALS patient
Ady Barkan that he would seek to create ARPA-H, modeled after DARPA, to
solve issues relating to the diagnosis and treatment of disease. He
also promised that ALS-along with cancer, diabetes and Alzheimer's-
would be among the first diseases it tackled.
I was elated when President Biden's administration submitted a
proposal to fund ARPA-H to Congress. I was devastated when I saw that
only ALS was left out of the list of identified diseases it would
target.
To cure ALS, we need an ARPA-H. We need both a focus on high risk/
high reward research and to break down the antiquated, bureaucratic red
tape facing ALS patients seeking promising therapies. Moreover, if we
cure ALS, we can help unlock cures for Alzheimer's, Parkinson's,
Frontotemporal Dementia and beyond.
Today, despite the increases in funding over the last 2 years, our
government still spends less than $6,000 on ALS research per year per
person in the U.S. living with ALS. You have the power to fix this by
putting ALS back into ARPA-H.
Second, we need you to hold the FDA accountable for failing ALS
patients by denying any type of approval for two promising therapies
this year. On June 7th, we watched the FDA grant accelerated approval
of aducanumab for the treatment of Alzheimer's disease and wondered why
that same urgency has not been applied to ALS.
In September 2019, FDA released an updated Guidance for ALS
Clinical Trials. It stressed the need for ``regulatory flexibility in
applying the statutory standards to drugs for serious diseases with
unmet medical needs.'' The Guidance explicitly stated that ``[w]hen
making regulatory decisions about drugs to treat ALS, FDA will consider
patient tolerance for risk and the serious and life-threatening nature
of the condition in the context of statutory requirements for safety
and efficacy.''
The first two tests of FDA's promise of regulatory flexibility and
urgency for ALS came this year with AMX0035, an oral medication, and
NurOwn, a stem cell therapy. The Phase II/III trial for AMX0035 showed
that AMX0035 slowed the progression of ALS and enabled patients on
average to live 6.5 months longer. NurOwn's Phase III trial did not
show the same overall benefit, but did show a ``clinically meaningful''
slowing of progression for a subgroup of ALS patients.
FDA's response: No approval for either therapy. No regulatory
flexibility. No consideration of the terminal nature of ALS. No regard
for the tens of thousands of patients, caregivers and advocates who
signed petitions to the FDA pleading for access to these therapies.
Instead, the FDA reverted to the same inflexible position for both
therapies: they asked each company to run another large, long placebo-
controlled trial and then come back. Let me make crystal clear what
these two decisions by FDA mean: at best these therapies won't be
accessible to patients for 4 years. By then nearly every ALS patient
alive today will be dead.
Why weren't these therapies approved? Both therapies showed
efficacy for at least a subgroup of ALS patients. And if the concern
was safety, both trials showed a strong safety profile-particularly in
the context of a 100% fatal disease. Moreover, the denials deprived
patients of the chance to access FDA-regulated drugs under the
supervision of an ALS specialist. So, instead, patients are forced to
try to replicate the formula for AMX0035 on their own and to travel
abroad for risky stem cell procedures.
I've been told that the FDA has claimed to members of Congress and
their staff that they are doing everything they can and that there was
nothing else they could do with respect to these two therapies. This is
simply not true or, if FDA actually believes this, they have provided
Congress a clarion call to reform how FDA regulates treatments for
diseases like ALS.
I am a former federal government employee. I come from a family of
former and current federal government employees. I truly believe the
FDA is filled with honorable, dedicated public servants. However, their
actions here are impossible to square with their own Guidance. This is
most clearly demonstrated by the fact that AMX0035 appears headed
towards approvals in Canada and Europe based on the same data presented
to FDA. FDA stands alone as an immovable obstacle.
I implore Congress to hold hearings on these denials to bring
transparency and accountability to a process that has left the ALS
community devastated.
In addition to hearings, I ask you to pass and fund 2 bills to
ensure this does not happen again. Over the last year, the fight
against COVID-19 showed how much regulatory flexibility FDA has when it
wants to use it. Since FDA appears unwilling to use it to give ALS
patients a chance to live, we have worked with members of Congress to
reform how FDA approaches diseases like ALS.
The first, ACT for ALS, will, among other items, make a significant
amount of funding available to establish expanded access programs.
Programs that will make promising therapies available to ALS patients
now while fueling additional research into a therapy's safety and
efficacy.
The second, The Promising Pathways Act, will, among other things,
allow for conditional approval of promising therapies after Phase II
for life-threatening diseases like ALS. This would put us on par with
Europe.
Today, the science needed to cure ALS is moving faster than ever
and finally producing therapies that may be able to slow or stop this
disease. This reality must be matched by a new regulatory approach that
speeds promising therapies to patients. As I have outlined, despite
programs aimed to do just that which have worked in other diseases, we
do not have that approach for ALS today. It is our moral obligation to
change this broken approach for all those facing ALS just as we did for
HIV and cancer.
If we do, I will have a chance to see my daughters graduate from
kindergarten, high school, and college.
You have the power to make that happen.
I thank you for having the courage to do so.
And I look forward to working with each of you to finally defeat
ALS.
[This statement was submitted by Brian Wallach, Co-Founder, I AM
ALS.]
______
Prepared Statement of the Infectious Diseases Society of America
On behalf of the Infectious Diseases Society of America (IDSA),
which represents more than 12,000 physicians, scientists, public health
practitioners and other clinicians specializing in infectious diseases
prevention, care, research and education, I urge the Subcommittee to
provide robust FY2022 funding for public health and biomedical research
activities that save lives, contain health care costs and promote
economic growth. IDSA asks the Subcommittee to provide $10 billion for
the Centers for Disease Control and Prevention (CDC), $46.111 billion
for the National Institutes of Health (NIH), $300 million for the
Biomedical Advanced Research and Development Authority (BARDA) Broad
Spectrum Antimicrobials and CARB-X programs and $200 million for the
Strategic National Stockpile Special Reserve Fund program.
While we must continue to direct substantial resources to tackle
the COVID-19 pandemic, we must also address other domestic and global
infectious diseases threats and epidemics, including those for which
progress has stalled and/or worsened during the pandemic. For example,
routine immunization rates have fallen, and access to care for diseases
like HIV has been disrupted. In addition, high levels of antibiotic use
likely exacerbated existing antibiotic resistance, deepening the need
for antimicrobial stewardship, surveillance and new antimicrobial
drugs. The COVID-19 pandemic has shown us all too clearly the
fundamental importance of expanding the infectious diseases workforce,
public health infrastructure and biomedical research enterprise
necessary to successfully confront the panoply of infectious threats
facing our increasingly interconnected world.
centers for disease control and prevention
Antibiotic Resistance Solutions Initiative (ARSI)
We urge $672 million in funding for the Antibiotic Resistance
Solutions Initiative in FY2022. IDSA members see the impact that
antimicrobial resistance (AMR) has on patients daily. Antimicrobial
resistance is one of the greatest public health threats of our time.
Drug-resistant infections sicken at least 2.8 million each year and
kill at least 35,000 people annually in the United States. Antibiotic
resistance accounts for direct healthcare costs of at least $20
billion. If we do not act now, by 2050 antibiotic resistant infections
are expected to be the leading cause of death in the world.
We therefore recommend $672 million for the Antibiotic Resistance
Solutions Initiative to achieve the goals outlined in the 2020-2025
National Action Plan for Combating Antibiotic-Resistant Bacteria. The
ARSI is the cornerstone of the nation's efforts to detect, prevent, and
respond to AMR. The program is also a critical building block of CDC's
public health infrastructure that directly supports broader agency
activities, including COVID-19 first responders, foodborne illness
pathogen detection, sexually transmitted infections, health care
associated infections and global health. Increased funding would help
expand antibiotic stewardship across the continuum of care; double
grant awards at the state and local level; expand the Antibiotic
Resistance Laboratory Network globally and domestically to strengthen
the identification, tracking and containment of deadly pathogens;
support AMR research and epicenters; and increase public and health
care professional education and awareness activities. Since FY2016,
funding for the initiative has improved antibiotic use, increased state
and regional laboratory capacity to rapidly detect resistant infections
and enhanced tracking of health care-associated infections. However,
many state laboratories still do not monitor for and report resistance
data on pathogens of importance and the program will be unable to
effectively address current and newly emerging threats and prepare for
future challenges without a significant increase in funding in FY2022.
Increased funding is vital to achieving the plan's goals, including a
20 percent decrease in health care-associated antibiotic-resistant
infections and a 10 percent drop in community-acquired antibiotic-
resistant infections by 2025.
Advanced Molecular Detection
Advanced Molecular Detection (AMD) strengthens CDC's epidemiologic
and laboratory expertise to effectively detect and track pathogens,
including how they mutate, to inform responses and improve clinical
care of patients. AMD provides more rapid identification of pathogens
which can positively benefit antimicrobial stewardship to improve
patient outcomes and reduce AMR. Requested FY2022 funding of $60
million would further enhance federal, state and local laboratory
capabilities and spur innovation, including through further integration
of genomics and other advanced laboratory technologies into AMR
surveillance. Increased funding would help CDC apply the work of
SPHERES, a national genomics consortium led by AMD that coordinates
large-scale, rapid SARS-CoV-2 sequencing across the U.S., to bolster
AMR surveillance, detection and response.
National Healthcare Safety Network
FY2022 funding of $100 million for the National Healthcare Safety
Network (NHSN) will enable the program to meet its current and
projected demands. Requested funding would expand data collection on
antibiotic use and resistance in health care facilities as outlined in
the 2020-2025 National Action Plan for Combating Antibiotic-Resistant
Bacteria. In 2020, many additional health care facilities began
reporting COVID-19 data to NHSN, and new funding will help expand that
reporting to include antibiotic use and resistance data. FY2022 funding
would help achieve the National Action Plan goals for 75 percent of
acute care hospitals and 25 percent of critical access hospitals
reporting to the NHSN Antibiotic Resistance Option and 100 percent of
acute care and 50 percent of critical access hospitals reporting to the
NHSN Antibiotic Use Option. These data help measure and drive progress
toward optimizing antibiotic use. Additionally, increased funding would
provide access to technical support for more than 65,000 staff at
health care facilities who use NHSN.
CDC Center for Global Health
IDSA urges the Subcommittee to provide $857.8 million in FY2022
funding, including $456.4 million for CDC's Division of Global Health
Protection. Public health experts address more than 400 diseases and
health threats in 60 countries, including SARS-CoV-2. An emerging
infection in any part of the world is just a plane ride away from the
U.S. (or any other location). As highlighted by the COVID-19 pandemic,
increased resources for this vital CDC program are needed to improve
global capacity to prevent, detect and respond to health threats at
their source before international spread. As a key implementor of the
Global Health Security Agenda, the division works to improve health
emergency preparedness and response, enhance infectious disease
surveillance systems, strengthen laboratory capacity, train health care
workers and disease detectives and build and support emergency
operations centers in countries with limited public health capacities.
The current COVID-19 tragedy in India and Brazil underscores the
critical importance of global public health infrastructure. The program
also works to address AMR by providing technical assistance to 30
countries, working to detect resistant threats; prevent and contain
resistance pathogens; and improve antibiotic use. Other divisions in
the CDC Center for Global Health are instrumental in providing
technical assistance on HIV, tuberculosis (TB) and malaria and other
parasitic diseases, and also ensuring access to essential immunization
services for children in low- and middle-income countries. U.S.
leadership of global health security efforts is essential, and the
resources allocated to those efforts have been inadequate. Until all
countries have laboratory monitoring and surveillance capacities and
the trained staff and equipment necessary to detect and respond swiftly
to emerging infectious threats, we all will remain vulnerable.
Elimination of Opioid Related Infectious Diseases
$120 billion in funding for the Opioid-Related Infectious Diseases
program would allow CDC to address the significant and growing burden
of the opioid epidemic by expanding surveillance for infectious
diseases commonly associated with injection drug use, including HIV,
viral hepatitis and infective endocarditis. CDC has found steep
increases in multiple viral, bacterial and fungal infections due to
injection drug use, and CDC estimates that individuals who inject drugs
are 16 times more likely to develop an invasive Methicillin-resistant
Staphylococcus aureus (MRSA) infection. We are very concerned about how
the opioid crisis is driving higher rates of infectious diseases
including hepatitis C, endocarditis, HIV, and pneumonia, as well as
skin, soft tissue, bone, and joint infections. Support systems for
individuals with substance use disorders are suffering disruptions due
to the COVID-19 pandemic, which may be worsening the opioid epidemic
and associated infectious diseases.
assistant secretary for preparedness and response (aspr)
Biomedical Advanced Research and Development Authority (BARDA), Broad
Spectrum Antimicrobials and Combating Antibiotic-Resistant
Bacteria Biopharmaceutical Accelerator (CARB-X )
The BARDA Broad Spectrum Antimicrobials program and CARB-X leverage
public/private partnerships to develop products that directly support
the government-wide National Action Plan for Combating Antibiotic-
Resistant Bacteria and have been successful in developing new FDA-
approved antibiotics. To help achieve the plan's goals to accelerate
basic and applied research for developing new antibiotics and other
products, $300 million in FY2022 funding is needed. This funding will
help prevent a situation in which we lose many modern medical advances
that depend upon the availability of antibiotics, such as cancer
chemotherapy, organ transplantation and other surgeries.
Project BioShield Special Reserve Fund (SRF), Broad Spectrum
Antimicrobials
We recommend $200 million in funding for the Project BioShield SRF.
The SRF is positioned to support the response to public health threats,
including AMR. BARDA and National Institute of Allergy and Infectious
Diseases efforts have helped companies bring new antibiotics to market,
but those companies now struggle to stay in business and two filed for
bankruptcy in 2019. In December 2019, SRF funds supported a contract
for a company following approval of its antibiotic--a phase of drug
development during which small biotech firms are particularly
vulnerable. $200 million in funding would expand this approach to
better support the antibiotics market.
national institutes of health
National Institute of Allergy and Infectious Diseases (NIAID)
$6.520 billion for NIAID, including $600 million for AMR research,
would allow NIAID to address AMR while carrying out its broader role in
supporting infectious diseases research, including emerging infectious
diseases, HIV, TB and influenza. Increased FY2022 funding would
strengthen investment in the biomedical research workforce, including
training and efforts to support early-career physician-scientists and
promote diversity, update the national clinical trials infrastructure
to include community hospitals and enable access for underserved
populations.
The COVID-19 pandemic has demonstrated the need to better prepare
our biomedical research infrastructure to respond to emerging
infectious diseases and future emergencies, including the need to
strengthen and diversify the ID research workforce. High educational
debt, low research salaries, and competing work-life demands have
driven many promising researchers from the field. The current pandemic
has reportedly increased interest in infectious diseases as a career,
but translating increased interest into recruitment and retention
remains a challenge. Infectious diseases as a specialty only filled 88%
of positions and 75% of programs in the recent match; further, 80% of
counties in the US do not have an ID physician. Strong NIAID support
for career development through increased FY2022 funding and other
initiatives is critical to maintaining and improving the pipeline of
physician scientists committed to a career in ID. NIAID should use
increased resources to provide additional K, T, and F awards, and Early
Investigator Awards as well as new opportunities for community-based ID
physicians to participate in clinical trials and other research to
enhance recruitment, training and diversity of the physician-scientist
workforce.
The COVID-19 pandemic has exposed systemic deficits that threaten
our ability to combat future outbreaks and threats, such as AMR. FY2022
funding will allow NIAID to continue to respond to the pandemic and
prepare for future outbreaks while carrying out its broader role in
infectious diseases research. Such efforts include research on
antimicrobial mechanisms of resistance, therapeutics, vaccines and
diagnostics; development of a clinical trials network to reduce
barriers to research on emerging and difficult-to-treat infections; and
support for training more physician scientists and clinical
investigators to improve research capacity, for example, as outlined in
the 2020-2025 National Action Plan to Combat Antibiotic-Resistant
Bacteria.
conclusion
Thank you for the opportunity to submit this statement. The
nation's ID physicians and scientists rely on strong federal
partnerships to keep Americans healthy and urge you to support these
efforts. Please forward any questions to Lisa Cox at
[email protected].
[This statement was submitted by Barbara D. Alexander, MD, MHS,
FIDSA, IDSA, President, Infectious Diseases Society of America.]
______
Prepared Statement of the Integrative Health Policy Consortium
Thank you, Chair Murray and Ranking Member Blunt, for this
opportunity to testify in support of programs at the Department of
Health and Human Services under your Subcommittee's jurisdiction that
are important to the members of the Integrative Health Policy
Consortium (IHPC) (www.ihpc.org). Specifically, IHPC is writing to
express its support for funding the National Center for Complementary
and Integrative Health (NCCIH), a component of the National Institutes
of Health (NIH), and the Federally Qualified Health Centers (FQHCs)
program within the Health Resources and Services Administration (HRSA).
In addition, our testimony respectfully asks the Subcommittee to
support the inclusion of report language urging the Department of
Health and Human Services (HHS) to implement recommendations issued by
the HHS Pain Management Best Practices Inter-Agency Task Force.
The Integrative Health Policy Consortium (IHPC) IHPC is a broad-
based coalition of organizations whose mission is to eliminate barriers
to health. IHPC includes 26 organizations representing more than
650,000 state licensed, certified and/or nationally certified
healthcare professionals, including medical doctors, registered nurses,
doctors of chiropractic, naturopathic doctors, licensed acupuncturists,
licensed massage therapists, and academic, research, clinical, and
public education organizations. IHPC has championed the Congressional
Integrative Health & Wellness Caucus and functions to support the
federal agencies overseeing America's health and health research needs.
IHPC envisions a world with no barriers to health and is focused on
promoting a healthier world that incentivizes health creation for all
individuals, communities, and the planet.
national center for complementary and integrative health
IHPC appreciates the strong support that the Chair and Ranking
Member have given the NIH. IHPC shares your enthusiasm for the agency's
research and research training mission and encourages the subcommittee
to continue prioritizing NIH funding. In addition, we urge the
Subcommittee to provide the National Center for Complementary and
Integrative Health (NCCIH) with similar, commensurate increases. With
this additional support, NICCH could support its ongoing mission as
well as embark fully on a new, promising research initiative, the Whole
Health Perspective. This initiative would promote research looking at
the interactions between systems in the body, such as connections
between the brain and the heart, that predispose people to disease and
expand our understanding of integrative health and pathways to
improving health and preventing disease.
IHPC specially wants to draw attention to the importance of
including all the regulated integrative health systems and professions
in whole person research. One of the major lessons of the COVID-19
pandemic and the importance of optimal health is the need for each of
the major systems as well as integrative protocols to be studied in
real world environments to determine the whole person effect of regular
care through specific approaches such as acupuncture, naturopathic
medicine, chiropractic, homeopathy, holistic nursing, massage therapy,
lifestyle and functional medicine approaches, direct entry midwifery,
and traditional healing approaches from Native American and indigenous
communities.
IHPC joins other organizations in asking the Subcommittee to
provide NIH with $46.1 billion in FY 2022. This request, which is a
$3.177 billion (7.4%) increase over the comparable FY 2021 funding
level for the NIH, would allow for the agency's base budget to keep
pace with the biomedical research and development price index (BRDPI)
and allow meaningful growth of 5%. Further, such an increase would
expand NIH's capacity to support promising science across all
disciplines, particularly including the new Whole Health initiative
underway at NCCIH. IHPC asks the subcommittee to provide NCCIH with at
least a similar 7.4% funding increase in FY 2022.
federally qualified health centers
Federally Qualified Health Centers (FQHCs) are community-based
health care providers that receive funds from the HRSA Health Center
Program to provide primary care services in underserved areas. In
recent years, especially with the onset of the nation's opioid crisis,
FQHCs have emerged as a platform for Integrative Whole Health
innovation and for the delivery of non-pharmacologic pain management
services. During the COVID-19 pandemic, select FQHCs have expanded
their services to deliver pain management services to an increased
number of uninsured and underinsured individuals. To advance and expand
the FQHC mission, IHPC endorses the recommendation issued by the
National Association of Community Health Centers to provide community
health centers with $2.2 billion in discretionary funding in FY 2022.
Further, we respectfully request the Subcommittee to request a report
from HRSA in FY 2022 regarding the inclusion of regulated complementary
and integrative health professionals and services system wide, Medicare
and Medicaid reimbursement for services within the FQHC system and
barriers to access and reimbursement for non-pharmacologic pain
management services; and possible solutions to the elimination of noted
barriers.
hhs pain management best practices inter-agency task force
IHPC respectfully asks that the Subcommittee support the inclusion
of proposed report language, urging HHS to facilitate adoption of
recommendations from The Pain Management Best Practices Inter-Agency
Task Force and launch a public awareness campaign to educate Americans
about the differences between acute and chronic pain and the evidence-
based non-opioid (non-pharmacologic) treatment options that are
available. In 2019, this congressionally established task force issued
a ground-breaking report regarding best practices for managing acute
and chronic pain. Of note, the report underscores the philosophical and
cultural shift to focus on addressing chronic and acute pain by using
complementary and integrative health including non-pharmacologic
approaches that have been proven effective and are widely supported by
practitioners working in all healthcare settings. These treatment
options include acupuncture, massage therapy, physical and occupational
therapies, chiropractic, cognitive behavioral therapy, manipulative
therapy, yoga, tai chi, and meditation. If implemented, these
recommendations will have profound public health and positive national
economic impact on a significant percent of the U.S. population. The
IHPC stands ready to assist the agency and the Congress in advancing
this important public awareness.
Thank you for considering our views. The IHPC looks forward to
working with you to enact the FY 2022 Labor, Health and Human Services
and Education Appropriations bill and to help ensure our priorities are
addressed in the final version of this important funding legislation.
[This statement was submitted by Margaret Erickson, PhD, RN, CNS,
APRN, APHN-BD, Co-Chair, Integrative Health Policy Consortium.]
______
Prepared Statement of International Foundation for
Gastrointestinal Disorders
fiscal year 2022 l-hhs appropriations recommendations
_______________________________________________________________________
--At least $46.1 billion in program level funding for the National
Institutes of Health (NIH).
--Proportional funding increase for the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK).
--Please provide $10 billion for the Centers for Disease Control and
Prevention (CDC).
--Please provide $5 million for the Chronic Disease Education and
Awareness Program.
_______________________________________________________________________
Chairwoman Murray, Ranking Member Blunt, and distinguished members
of the Subcommittee, as you work with your colleagues to develop the
FY2022 Labor-Health and Human Services (L-HHS) appropriations bill,
please keep in mind the needs and concerns of the functional GI and
motility disorders community. Nearly two decades ago, I was diagnosed
with one of these diseases, irritable bowel syndrome (IBS). As a young
adult, I underwent extensive testing and workups over many years in a
difficult effort to discover what was causing my symptoms and how best
to treat them. I often relied on self-treatment as best as I could, but
this was not sustainable. Unfortunately, I am not alone in these
experiences. As President of IFFGD, I have heard my story echoed back
to me by thousands of others. Patients affected by these disorders
often face similar delays in diagnosis, frequent misdiagnosis, and
inappropriate treatments including unnecessary and costly surgery.
These are common concerns for our community, and they underscore the
need for increased research, improved provider education, and greater
public awareness.
about the foundation
The International Foundation for Gastrointestinal Disorders (IFFGD)
is a registered nonprofit education and research organization dedicated
to informing, assisting, and supporting people affected by
gastrointestinal (GI) disorders. IFFGD works with patients, families,
physicians, nurses, practitioners, investigators, regulators,
employers, and others to broaden understanding about GI disorders,
support and encourage research, and improve digestive health in adults
and children.
about gastrointestinal (gi) and motility disorders
GI and motility disorders are the most common digestive disorders
in the general population. These disorders are classified by symptoms
related to any combination of the following: motility disturbance,
visceral hypersensitivity, altered mucosal and immune function, altered
gut microbiota, and altered central nervous system (CNS) processing.
Some examples of functional GI disorders are: dyspepsia, gastroparesis,
irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD),
bowel incontinence, and cyclic vomiting syndrome. The costs associated
with these diseases range from $25-$30 billion annually; economic costs
are also reflected in work absenteeism and lost productivity.
centers for disease control and prevention
We greatly appreciate the support from the Subcommittee in creating
the Chronic Disease Education and Awareness Program in FY2021. Patients
with FGIMDs frequently suffer for years before receiving an accurate
diagnosis, exposing them to unnecessary and costly tests and procedures
including surgeries, as well as needless suffering and expense.
Functional GI and motility disorders are among the most common
digestive disorders in the general population. They affect an estimated
1 in 4 people in the U.S. and account for 40% of GI problems seen by
medical providers. A CDC program focused on surveillance, provider
education, and public awareness would increase diagnoses and improve
patient outcomes. We ask that the Subcommittee provide $5 million for
the Chronic Disease Education and Awareness Program in FY2022.
national institutes of health
Strengthening the nation's biomedical research enterprise through
NIH fosters economic growth and sustains innovations that enhance the
health and well-being of the American people. Functional GI disorders
are prevalent in about 1 in 4 people in the U.S., accounting for 40% of
GI problems seen by medical providers. NIDDK supports basic, clinical,
and translational research on aspects of gut physiology regulating
motility and supports clinical trials through the Motility and
Functional GI Disorders Program.
Several of NIH's crosscutting initiatives are currently advancing
science in meaningful ways for patients with gastrointestinal
disorders. The Stimulating Peripheral Activity to Relieve Conditions
(SPARC) Initiative supports research on the role that nerves play in
regulating organ function. Methods and medical devices that modulate
these nerve signals are a potentially powerful way to treat many
chronic conditions, including gastrointestinal and inflammatory
disorders. The Human Microbiome Project is also unlocking important
discoveries that will help to inform and advance emerging treatment
options for many in the community.
patient perspective--jacqui's story
I got sick after an emergency appendectomy on Thanksgiving 2010
while I was in Army basic training. I was able to fight off the
inevitable and did four years in the Army during which I did a tour in
Afghanistan. When I got back, my health really started declining.
I fought and fought and fought for an answer, but it took just over
seven years to be diagnosed with gastroparesis. My main symptoms were
nausea, vomiting and pain. It got so bad that I had to give up my dream
career and was medically retired from the service.
Because we had tried pretty much every conservative treatment, they
told me I would just have to live with it. It got to the point where I
was going weeks without eating and was in and out of the ER getting
fluids, because anything that went in my stomach came back up. My hair
thinned, so I shaved it, and I was having memory problems and
confusion, which got so bad that my neuropsych tests came back with my
score being in the range of dementia.
My gastroenterologist even told me at one point that she couldn't
do anything ``drastic'' to help me until my blood work was ``bad
enough.''
Thank you for the opportunity to submit our community's
perspective, as you consider appropriations priorities for FY 2022. We
look forward to continuing to work with you on these critical issues.
[This statement was submitted by Ceciel T. Rooker, President and
Executive
Director, International Foundation for Gastrointestinal Disorders.]
______
Prepared Statement of the Interstate Mining Compact Commission
We are writing in regard to the fiscal year 2022 Budget for the
Mine Safety and Health Administration (MSHA), U.S. Department of Labor.
In particular, we urge the Subcommittee to support a full appropriation
for state assistance grants for safety and health training of our
Nation's miners pursuant to section 503(a) of the Mine Safety and
Health Act of 1977 (the Act). MSHA's budget for at least the last five
fiscal years has included an amount of not less than $10,537,000 for
state assistance grants. We are pleased to see that President Biden's
fiscal year 2022 budget proposes to continue funding at this level. We
urge the Subcommittee to fund these grants at this statutorily
authorized level for state assistance grants so that states are able to
meet the training needs of miners and to fully and effectively carry
out important state responsibilities under section 503(a) of the Act.
We believe the states can more than justify the need for funding at the
statutorily authorized level.
The Interstate Mining Compact Commission is a multi-state
governmental organization that represents the natural resource,
environmental protection and mine safety and health interests of its 26
member states. The states are represented by their Governors who serve
as Commissioners.
We support full funding $10,537,000 for the state assistance grants
that enable the states to provide essential safety and health training
for the nation's coal miners, undiminished by use of these funds for
other purposes. Section 503 of the Act was structured to be broad in
scope and to stand as a separate and distinct part of the overall mine
safety and health program. In the Conference Report that accompanied
passage of the Federal Coal Mining Health and Safety Act of 1969, the
conference committee noted that both the House and Senate bills
provided for ``Federal assistance to coal-producing States in
developing and enforcing effective health and safety laws and
regulations applicable to mines in the States and to promote Federal-
State coordination and cooperation in improving health and safety
conditions in the Nation's coal mines.'' (H. Conf. Report 91-761). The
1977 Amendments to the Mine Safety and Health Act expanded these
assistance grants to both coal and metal/non-metal mines and increased
the authorization for annual appropriations to $10 million. The
training of miners was only one part of the obligation envisioned by
Congress.
With respect to the training component of our mine safety and
health programs, IMCC's member states are concerned that without full,
stable funding of the State Grants Program, the federally required
training for miners employed throughout the U.S. will suffer. Our
experience over the past 40 years has demonstrated that the states are
often in the best position to design and offer mine safety and health
training in a way that insures that the goals and objectives of
Sections 502 and 503 of the Mine Safety and Health Act are adequately
met. We greatly appreciate Congress' recognition of this fact and this
Subcommittee's strong support for state assistance grants, especially
in past years when the Administration sought to eliminate or
substantially reduce those moneys.
We also appreciate the recognition by Congress that the
availability of these funds to states should not be diminished by
allowing them to be used for other purposes. We urge Congress to reject
any attempt to diminish the funds available to states in the budget it
adopts for fiscal year 2022 and future years. The budget that is
adopted should include the full amount of $10,537,000 for state
assistance grants, without any provisos or other qualifications that
could reduce the amount of money states receive.
Thank you for the opportunity to present our views on the proposed
fiscal year 2022 budget for MSHA.
[This statement was submitted by Thomas L. Clarke, Executive
Director,
Interstate Mining Compact Commission.]
______
Prepared Statement of the Interstitial Cystitis Association
summary of recommendations for fiscal year 2022
_______________________________________________________________________
--Provide $1.5 million for the IC Education and Awareness Program and
the IC Epidemiology Study at the Centers for Disease Control
and Prevention (CDC)
--Provide $46.1 billion for the National Institutes of Health (NIH)
and Proportional Increases Across all Institutes and Centers
--Support NIH Research on IC, including the Multidisciplinary
Approach to the Study of Chronic Pelvic Pain (MAPP) Research
Network and Chronic Pain
_______________________________________________________________________
Thank you for the opportunity to present the views of the
Interstitial Cystitis Association (ICA) regarding interstitial cystitis
(IC) public awareness and research. ICA was founded in 1984 and is the
only nonprofit organization dedicated to improving the lives of those
affected by IC. The Association provides an important avenue for
advocacy, research, and education. Since its founding, ICA has acted as
a voice for those living with IC, enabling support groups and
empowering patients. ICA advocates for the expansion of the IC
knowledge-base and the development of new treatments. ICA also works to
educate patients, healthcare providers, and the public at large about
IC.
IC is a condition that consists of recurring pelvic pain, pressure,
or discomfort in the bladder and pelvic region. It is often associated
with urinary frequency and urgency. This condition may also be referred
to as painful bladder syndrome (PBS), bladder pain syndrome (BPS), and
chronic pelvic pain (CPP). It is estimated that as many as 12 million
Americans have IC symptoms. Approximately two-thirds of these patients
are women, though this condition does severely impact the lives of as
many as 4 million men. IC has been seen in children and many adults
with IC report having experienced urinary problems during childhood.
However, little is known about IC in children, and information on
statistics, diagnostic tools and treatments specific to children with
IC is limited.
The exact cause of IC is unknown and there are few treatment
options available. There is no diagnostic test for IC and diagnosis is
made only after excluding other urinary/bladder conditions. It is not
uncommon for patients to experience one or more years delay between the
onset of symptoms and a diagnosis of IC. This is exacerbated when
healthcare providers are not properly educated about IC.
The effects of IC are pervasive and insidious, damaging work life,
psychological well-being, personal relationships, and general health.
The impact of IC on quality of life is equally as severe as rheumatoid
arthritis and end-stage renal disease. Health-related quality of life
in women with IC is worse than in women with endometriosis, vulvodynia,
and overactive bladder. IC patients have significantly more sleep
dysfunction, and higher rates of depression, anxiety, and sexual
dysfunction.
Some studies suggest that certain conditions occur more commonly in
people with IC than in the general population. These conditions include
allergies, irritable bowel syndrome, endometriosis, vulvodynia,
fibromyalgia, and migraine headaches. Chronic fatigue syndrome, pelvic
floor dysfunction, and Sjogren's syndrome have also been reported.
ic public awareness and education through cdc
ICA recommends a specific appropriation of $1.5 million in fiscal
year 2022 (FY2022) for the CDC IC Program. This will allow CDC to fund
the Education and Awareness Program, per ongoing congressional intent,
as well as the IC Epidemiology Study.
CDC had shifted the focus of the IC program to an epidemiology
study and away from education and awareness, but thanks to the
Subcommittee the ICA and IC community have been able to open
discussions with CDC to ensure a renewed focus on education and
awareness activities. The IC community had been concerned that focusing
solely on an epidemiology study instead of on education and awareness
activities was detrimental to patients and their families. We have
recently met with CDC thanks to the actions of this Subcommittee where
we openly and effectively communicated the need for CDC to include ICA
in any collaboration along with the epidemiology study. We know that
CDC has not received as generous increases as NIH over the past few
fiscal years, but it is important the CDC continue supporting both
critical components of the IC Program. The CDC IC Education and
Awareness Program is the only federal program dedicated to improving
public and provider awareness of this devastating disease, reducing the
time to diagnosis for patients, and disseminating information on pain
management and IC treatment options. ICA urges Congress to provide
funding for IC education and awareness in FY2022.
The IC Education and Awareness program has utilized opportunities
with charitable organizations to leverage funds and maximize public
outreach. Such outreach includes public service announcements in major
markets and the internet, as well as a billboard campaign along major
highways across the country. The IC program has also made information
on IC available to patients and the public though videos, booklets,
publications, presentations, educational kits, websites, self-
management tools, webinars, blogs, and social media communities such as
Facebook, YouTube, and Twitter. For healthcare providers, this program
has included the development of a continuing medical education module,
targeted mailings, and exhibits at national medical conferences.
The CDC IC Education and Awareness Program also provided patient
support that empowers patients to self-advocate for their care. Many
physicians are hesitant to treat IC patients because of the time it
takes to treat the condition and the lack of answers available.
Further, IC patients may try numerous potential therapies, including
alternative and complementary medicine, before finding an approach that
works for them. For this reason, it is especially critical for the IC
program to provide patients with information about what they can do to
manage this painful condition and lead a normal life. With the recent
developments in our conversations with the CDC we are confident that we
will continue to provide key education and awareness that will continue
to benefit the IC community.
ic research through the national institutes of health
ICA recommends a funding level of $46.1 billion for NIH in FY2022.
ICA also recommends continued support for IC research including the
MAPP Study administered by NIDDK.
The National Institutes of Health (NIH) maintains a robust research
portfolio on IC with the National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK) serving as the primary Institute for IC
research. The NIDDK Multidisciplinary Approach to the Study of Chronic
Pelvic Pain (MAPP) Research Network has continued to include cross-
cutting researchers who are currently identifying different phenotypes
of the disease. Phenotype information will allow physicians to
prescribe treatments with more specificity. Research on chronic pain
that is significant to the community is also supported by the National
Institute of Neurological Disorders and Stroke (NINDS) as well as the
National Center for Complementary and Integrative Health (NCCIH). The
vast majority of IC patients often suffer major and multiple quality of
life issues due to this condition. Many IC patients are unable to work
full time because pain affects their mobility, sleep, cognition, and
mood. These are people that simply want to lead productive lives, and
need pain medication to do so. Due to the fact that IC is categorized
as a non-cancer pain condition, IC patients already have a difficult
time obtaining pain meds. IC doctors do not have time nor the
inclination to effectively prescribe or monitor the distribution of the
opioid class of medication. They often refer their patients to Pain
Management Specialists, many who have never heard of IC, who often
refuse to treat them. In addition, antidepressants and benzodiazepines
are often used to treat both mood and sleeping disorders for IC
patients. Additionally, the NIH investigator-initiated research
portfolio continues to be an important mechanism for IC researchers to
create new avenues for interdisciplinary research.
patient perspective
IC is a tough disease to diagnose, and it is one of the most
challenging things to deal with, finding a doctor that specializes in
IC that can help diagnose and treat. I can't stress enough how
important finding the right doctor is. IC patients need a doctor who
understands and is willing to go along with them on this long,
frustrating, painful and confusing road. I have found strength through
having this that I never knew I had, strength to keep going when all
treatments so far have failed me.
There are a small number of treatments available for managing IC
symptoms, but they only work on a small percentage of patients. I have
tried those treatments and some drugs that ``might'' help. I manage my
diet, take lots of supplements and have to see all kinds of doctors
now. I have six! That includes holistic medicine doctors, physical
therapists, and acupuncturist. That's along with my regular MD,
urologist and two different gynecologists. This is what my life has
become. The life of an IC patient. I deal with one or more symptoms of
IC EVERY SINGLE DAY. Some days definitely better than others, but every
single day. It affects my life in so many ways. Work, social, travel
and my intimate relationships. I never know how I'm going to feel from
one day to the next. Anxiety and fear included.
Thank you for the opportunity to present the views of the
interstitial cystitis community.
[This statement was submitted by Lee Lowery, Executive Director,
Interstitial Cystitis Association.]
______
Prepared Statement of the Learning and Education Academic Research
Network
The Learning and Education Academic Research Network (LEARN), a
coalition of 38 of the nation's leading research colleges of education
across the country, advocates for the importance of research on
learning and development. Education research provides the bedrock of
knowledge used by our principals, teachers, counselors and professors
to help preK-12 students and those seeking a postsecondary education
succeed. With the staggering learning loss being experienced by
students due to the COVID-19 pandemic, it is critical that Congress
provides education research with the resources to guarantee that
educational interventions are innovative, evidence-based and effective.
LEARN urges the Subcommittee to meet the President's fiscal year (FY)
2022 budget request of 737.5 million for the Institute of Education
Sciences (IES) overall with $267.9 million dedicated to Research,
Development and Dissemination (RD&D). LEARN also requests that the
Subcommittee provide $70 million for the National Center for Special
Education Research (NCSER). In addition to requesting that the
Subcommittee meet the President's FY2022 budget request of $1.94
billion for National Institute of Child Health and Human Development
(NICHD), LEARN requests that the Subcommittee provide $2.21 billion for
National Institute of Mental Health (NIMH) in FY2022.
While advocating for these increased resources for FY2022, we want
to express our appreciation for the increases for IES that were made in
FY2021. We would also like to thank Congress for the inclusion of $100
million for IES in the American Rescue Plan Act; this investment marks
Congress' awareness of the importance of education research in
addressing the nation's most difficult educational challenges. An
increased investment in IES for FY2022 would allow for a more robust
development, and dissemination of valuable education research to
innovatively address the vast array of educational challenges posed
before, during and after the COVID-19 pandemic.
institute of education sciences
The work of IES and its grantees can guide the nation's learning
recovery so that we can exit the pandemic with a stronger, more
equitable, educational system than we entered with. As the primary
Federal agency charged with supporting research for education practice
and policy, IES is essential to developing a comprehensive, reliable
evidence base, and ensuring that teaching and learning practices are
grounded in scientifically valid research. Unfortunately, IES is only
able to fund one out of every 10 applications it receives due to the
limitations in its budget, despite a far greater percentage of such
applications being rated excellent and worth of funding.
Without a critical examination of what works and what does not work
to further knowledge, our education systems would be left to the same
curriculum, instructional techniques and assessments, regardless of
whether they spur student success. Examples of critical education
research funded by IES include the development and adoption of a
statewide approach to math instruction in one State that is now
utilized in other States; the development and implementations of a
reading curriculum now being adopted as a statewide literacy approach
by a State legislature and improved instructional and behavioral
practices for children with disabilities. Without continued support for
general education research infrastructure, notable programs like these
would not exist to address some of the nation's longest standing
educational challenges and support the nation's most at-risk students.
The physical closure of schools and transition to virtual learning
due to the COVID-19 pandemic has greatly disrupted education research
at a time when it is more critical than ever before. Although IES
grantees have adjusted their research where possible to remote and
hybrid instruction, this pivot has also resulted in unanticipated
costs, delays and cancellations; these increased costs are likely to
persist through 2022. Nevertheless, IES funded work has provided
insightful research findings and valuable tools for educators and
caregivers throughout the pandemic. This includes a longitudinal study
on the impact of COVID-19 on the educational attainment of economically
disadvantaged undergraduates and an interactive tool guide on teaching
math to young children at home. The work of IES and its grantees have
already begun guiding the nation towards a strong and successful
educational recovery.
The focus IES drives on education research is especially important
today as our schools must ensure that efforts to reduce learning loss
because of the COVID-19 pandemic are rooted in research and evidence-
based practice. Given the importance of developing reliable evidence,
LEARN is requesting that the Subcommittee meet President Biden's FY2022
request for $737.5 million for IES overall and $267.9 million for the
Research, Development, and Dissemination (RD&D) line item within IES.
These resources for the RD&D line item will build upon the critical
resources provided in the American Rescue Plan Act for IES to further
combat the negative learning outcomes resulting from the COVID-19
pandemic. The President's request for a 15 percent increase towards IES
and a 35 percent increase for the RD&D line item is further evidence of
the importance of supporting education research and evidence-based
practices in response to the challenges of the COVID-19 pandemic.
In addition, we recommend that funding for research in special
education, through the National Center for Special Education Research
(NCSER), should be increased to $70 million. NCSER is the only Federal
agency specifically designated to develop and provide evaluations for
programs for students with disabilities, but currently has a budget
that has remained relatively flat since FY2014. Research funded by
NCSER provides special educators and administrators research-based
resources that improve educational academic outcomes for children with
or at risk of disabilities. During a time when special education
students have been dramatically impacted by the change in schooling due
to COVID-19, additional funding to NCSER is necessary to support data
and evidence-based resources to guide the continued COVID-19 response
and recovery for these students. Funding of $70 million would allow for
a new competition in FY2022, allowing further resources to address
COVID-19 learning issues.
national institutes of health
There are critical education research programs within the National
Institutes of Health (NIH) that also need additional support. NICHD is
essential to education research as it examines brain functions and the
impact of different educational services on learning and development.
LEARN supports an increase in NICHD funding to $1.94 billion. This
increase will ensure that researchers can build on the knowledge
already gained, evaluate what works best in treating developmental
disorders and develop new research-based strategies to improve
student's learning and development. Additionally, it will support
NICHD's efforts to understand the effects of COVID-19 on key at-risk
populations, including the cognitive development of children and
adolescents.
LEARN also supports an increase in funding for NIMH to $2.21
billion. This increase will help further understanding of the
behavioral, biological and environmental mechanisms necessary for
developing interventions to reduce the burden of mental and behavioral
disorders and optimize learning and development. The untraditional
school year and strains of the COVID-19 pandemic has had a largely
negative impact on the mental health of children and adolescents
nationwide, it is important that research in this field is supported to
address these challenges.
LEARN believes it is critical that evidence-based research is
implemented and applied to schools nationwide as they work to address
the myriad of educational challenges that existed prior, and were
exacerbated, by the COVID-19 pandemic. As the nation looks towards
recovery, IES and NIH must be at the forefront of any effort to ensure
that Federal resources are going towards effective programming and
interventions. The LEARN Coalition strongly believes that key
investments in education research through IES and NIH will drive
improvements in teacher and student performance in the coming years and
allow for the beginning of a successful recovery from the COVID-19
pandemic. Thank you for your commitment to sustaining and strengthening
the nation's education research infrastructure.
Respectfully submitted,
[Camilla P. Benbow, Ed.D., Co-Chair, Learning and Education
Academic Research Network]
[Patricia and Rodes Hart Dean of Education and Human Development of
the
Peabody College of Education and Human Development, Vanderbilt
University]
[Rick Ginsberg, Ph.D., Co-Chair, Learning and Education Academic
Research
Network, Dean of the School of Education, University of Kansas]
[Glenn E. Good, Ph.D., Co-Chair, Learning and Education Academic
Research Network, Dean of the College of Education, University of
Florida]
______
Prepared Statement of the Lymphatic Education & Research Network
key recommendations
_______________________________________________________________________
--Establish a National Commission on Lymphatic Disease Research at
the NIH to identify emerging opportunities, challenges, gaps,
structural changes, and recommendations on lymphatic disease
research
--Provide the National Institutes of Health (NIH) with $46.1 billion
for FY 2022 and advance lymphatic disease research by expanding
resources and encouraging better coordination among relevant
institutes and centers
--Provide the Centers for Disease Control and Prevention (CDC) with
$10 billion for FY 2022 and enable $5 million for the Chronic
Disease Education and Awareness Program.
_______________________________________________________________________
Chairwoman Murray, Ranking Member Blunt and distinguished members
of the Subcommittee, thank you for the opportunity to submit the
priorities of the lymphatic diseases community you as you consider FY
2022 appropriations for the National Institutes of Health (NIH) and the
Centers for Disease Control and Prevention (CDC).
about le&rn
The Lymphatic Education & Research Network (LE&RN) is an
internationally recognized non-profit organization founded in 1998 to
fight lymphatic diseases and lymphedema through education, research and
advocacy. With chapters throughout the world, LE&RN seeks to accelerate
the prevention, treatment and cure of these diseases while bringing
patients and medical professionals together to address the unmet needs
surrounding lymphatic diseases, which include lymphedema and lipedema.
about lymphedema and lymphatic diseases
The lymphatic system is a circulatory system that is critical to
immune function and good health. When it is compromised and lymph flow
is restricted, the physical impact to patients can be devastating, life
altering, and can lead to shortened lifespan. Lymphedema (LE) is one
such lymphatic disease. LE is a chronic, debilitating, and incurable
swelling that can be a result of cancer treatment, inherited or genetic
causes, and damage to the lymphatic system from surgery or an accident,
or from parasites as in lymphatic filariasis. Stanford University
estimates that up to 10 million Americans have lymphedema. This
represents more Americans than those living with AIDS, Multiple
Sclerosis, Parkinson's disease, Muscular Dystrophy and ALS--combined.
The World Health Organization puts the global number of people with
this disease at 250 million. There is no cure. There is no approved
drug therapy. And there are currently only three drug studies worldwide
seeking a treatment. Psychosocially bruised by a disease that leaves us
deformed, we do our best to hide our lymphedema. We are currently
isolated and alone.
Lymphedema is an equal opportunity disease, affecting women, men
and children alike. Many are born with congenital or hereditary
lymphedema. Others, like our veterans, get the disease as a result of
physical trauma, bacterial infection, or as result of exposure to burn
pits. Lymphedema is an ignored disease. A study concluded that
physicians are currently getting an average of only 15-30 minutes of
study on the lymphatic system in their entire medical training. This
leaves them ill-prepared to diagnose the disease. Misdiagnosis leads to
improper treatment. Those who are diagnosed find it difficult to find
certified lymphedema therapists. Few medical centers exist that are
prepared to address lymphatic diseases. Surgeons are experimenting with
treatment that could alter the course of the disease. However, the
necessary basic research is not being done to inform their procedures.
And currently, Medicare and Medicaid do not cover some of the basic
treatment needs of these patients--such as compression garments, which
must be worn daily by patients.
fiscal year 2022 appropriations recommendations
We have been hopeful with recent advancements, but more needs to be
done. We ask that within 20 years, we will make lymphedema a truly
treatable disease. To reach this goal will require a commitment to
important medical research. LE&RN joins the broader medical research
community in thanking Congress for continuing to provide the National
Institutes of Health with proportional and sustainable funding
increases over the past several fiscal years, and we ask you all to
continue to prioritize these activities by providing at least a $46.1
billion for NIH in FY 2022.
We continue to urge the Subcommittee to work to expand and advance
the lymphatic disease portfolio at the NIH. In late 2015, the NIH
hosted a Lymphatic Symposium, where experts in the field identified a
scientific roadmap that could build the research portfolio up to a
level of at least $70 million annually over subsequent years by funding
meritorious grants on critical topics. In an effort to further support
and enhance emerging lymphedema and lymphatic disease research
activities, we ask the Subcommittee to encourage further collaboration
among relevant institutes and centers conducting research in this area.
We are grateful to the Subcommittee for continuing to support the
establishment of a National Commission on Lymphatic Disease Research,
which can thoroughly examine the portfolio and make recommendations on
how best to advance this emerging scientific area under NIH's current
structure. We ask that you continue to impress on NIH the critical need
for this Commission and how they can work with relevant stakeholders
such as ourselves. Currently, the National Institutes of Health spends
approximately $25 million annually on lymphatic research, and only $5
million of this is dedicated to clinical lymphedema research. Experts
state with confidence that there is no other disease affecting more
Americans that receives so little attention. It must also be noted that
study of the lymphatic system is poised to bring miracles for a host of
diseases that are part of the lymphatic continuum: obesity, heart
disease, diabetes, Rheumatoid arthritis, cancer metastasis, AIDS,
Crohn's disease, lipedema, and a host of other diseases. Recent
research discovered lymphatics surrounding the brain, which now has us
studying its impact on Alzheimer's disease and multiple sclerosis. We
appreciate the Subcommittee's continued support for the establishment
of a National Commission on Lymphatic Diseases and ask that NIH be held
accountable for the lack of progress on its establishment.
LE&RN also joins the public health community in asking Congress to
provide the Centers for Disease Control and Prevention (CDC) with $10
billion through FY 2022 and to increase funding to increase awareness,
education, and surveillance of lymphatic diseases. We encourage the
Subcommittee to support $5 million for the Chronic Disease Education
and Awareness Program in FY2022 which will allow CDC to work with
stakeholder organizations to expand important initiatives on chronic
diseases such as lymphedema and lymphatic diseases. Formal study of the
lymphatic system and of lymphatic diseases is virtually nonexistent in
the current curricula of U.S. medical schools, and misinformation
routinely leads to misdiagnosis and under-treatment. This delay and
misdirection of treatment results in irreparable physical and
psychosocial harm to patients suffering from these already debilitating
diseases. CDC can help to address this lack of public and provider
awareness.
Thank you for the opportunity to testify before you today. LE&RN
looks forward to working with you all to advance medical research and
public health activities that will improve patient outcomes for the
members of our community suffering from these debilitating diseases.
[This statement was submitted by William Repicci, President and
CEO,
Lymphatic Education & Research Network.]
______
Prepared Statement of the March of Dimes
March of Dimes, the nation's leading nonprofit organization
fighting for the health of all moms and babies, appreciates this
opportunity to submit testimony for the record on fiscal year (FY) 2022
appropriations for the Department of Health and Human Services (HHS).
March of Dimes leads the fight for the health of all mothers and
infants through our research, community services, education, and
advocacy.
Our organization strongly supports President Biden's historic HHS
budget proposal for FY 2022 which includes strong increases for
critical programs supporting families, and we recommend the following
funding levels for programs and initiatives that are essential
investments in maternal and child health.
Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD): March of Dimes recommends that Congress provide no
less than $1.7 billion for NICHD's groundbreaking biomedical research
activities in FY 2022. Increased funding will allow NICHD to sustain
vital research on preterm birth, maternal mortality, maternal substance
use, prenatal substance exposure and related issues through extramural
grants, Maternal-Fetal Medicine Units, the Neonatal Research Network
and the intramural research program.
Additionally, now that the Task Force on Research Specific to
Pregnant and Lactating Women (PRGLAC) has laid the foundation for
addressing research on safe and effective therapies for pregnant and
lactating women in clinical trials by releasing recommendations in
September 2018, as mandated by Congress in the 21st Century Cures Act
(P.L. 114-255), and provided an additional implementation plan
increased funding will allow for NICHD to more closely look at ways to
include and integrate pregnant and lactating women in clinical trials.
NICHD funding also supports research to address gaps in our
understanding of the best way to treat mothers with opioid use disorder
and the long-term impact of opioid exposure in utero. We support the
inclusion of this dedicated funding to address the nation's preterm
birth crisis.
Surveillance for Emerging Threats to Mothers and Babies Initiative:
March of Dimes recommends funding the Surveillance for Emerging Threats
to Mothers and Babies Initiative Program (known as SET-NET) within the
National Center for Birth Defects and Developmental Disabilities at
Centers for Disease Control and Prevention (CDC) at $100 million. SET-
NET was created during the Zika outbreak, which allowed CDC to create,
a unique nationwide mother-baby linked surveillance network to monitor
the virus' impact in real-time to inform clinical guidance, educate
health care providers and the community, and connect families to care.
Unfortunately, states were unable to sustain systems due to the program
being chronically underfunded, and we were left without a national
system to mobilize when COVID-19 struck.
Consequently, we have an incomplete picture on how to best care for
mothers and babies with confirmed or suspected virus infection as the
CDC currently only supports 29 state, local, and territorial health
departments. The increased funding will allow for CDC to address these
knowledge gaps and expand the initiative to provide real-time clinical
and survey data from all 50 states, territories and jurisdictions on
the impact of COVID-19 and new public health threats.
Perinatal Quality Collaboratives: PQCs are state or multistate
networks working to improve the quality of obstetric care and improve
outcomes. Currently, CDC funds 13 state-based PQCs that are
implementing recommendations across health facility networks. However,
many PQCs lack adequate resources to meet demands and reach their
maximum potential. We request no less than $30 million to fully scale
these programs in all states, an increase of $26.5 million.
Maternal Mortality Review Committees: Under the Enhancing Reviews
and Surveillance to Eliminate Maternal Mortality (ERASE MM) Program,
CDC provides funding, technical assistance, and guidance to state
maternal mortality review committees. These multidisciplinary
committees identify, review and characterize maternal deaths and
prevention opportunities. Currently, CDC has made 24 awards and
supports 25 state agencies and organizations that coordinate and manage
MMRCs. However, more standardized data collection is needed to help
examine all the factors contributing to severe maternal mortality,
preventable deaths, and poor birth outcomes. To this end, we request no
less than $30 million, an increase of $15 million, to reach all 50
states, DC, and Puerto Rico and tribes with enhanced technical
assistance to maximize MMRCs.
Newborn Screening: Newborn screening is one of our nation's most
successful public health programs. Each year, nearly every one of the
approximately 4 million infants born in the United States is screened
for certain genetic, metabolic, hormonal and/or functional conditions.
The early detection afforded by newborn screening ensures that infants
who test positive for a screened condition receive prompt treatment,
saving or improving the lives of more than 12,000 infants each year.
Both the Newborn Screening Quality Assurance Program at CDC and the
Heritable Disorders program at Health Resources and Services
Administration's (HRSA) have significantly improved the quality of
newborn screening programs throughout the country. NSQAP works hand-in-
hand with state laboratories by performing quality testing for more
than 500 laboratories to ensure the accuracy of newborn screening
tests. Where the Heritable Disorders program provides assistance to
states to improve and expand their newborn screening programs and
supports the work of the Advisory Committee on Heritable Disorders in
Newborns and Children (ACHDNC), which provides recommendations to the
HHS Secretary for conditions to be included in the Recommended Uniform
Screening Panel (RUSP). To continue sustaining, improving, and
enhancing these programs, March of Dimes urges funding of $28 million
for NSQAP and $28.883 million for the Heritable Disorders program for
FY22.
Grants for Maternal Depression Screening and Treatment: 1 in 5
women are affected by anxiety, depression, and other maternal mental
health (MMH) conditions during pregnancy or the year following
pregnancy. These illnesses are the most common complication of
pregnancy and childbirth, impacting 800,000 women in the United States
each year. Sadly, MMH conditions often go undiagnosed and untreated,
increasing the risk of multigenerational long-term negative impact on
the mother's and child's physical, emotional, and developmental health,
increasing the risk of poor health outcomes of both the mother and
baby. Furthermore, women of color and women who live in poverty are
disproportionately impacted by MMH conditions, experiencing them 2-3
times the rate as White women.
At the current funding level, only seven states have received
grants to provide real-time psychiatric consultation, care
coordination, and training for front-line providers to better screen,
assess, refer and treat pregnant and postpartum women for depression
and other behavioral health conditions. March of Dimes urges the
Committee to provide $10 million in FY 2022 to add five programs and
provide technical assistance to non-grantee states.
Maternal Mental Health Hotline: We thank the Committee for funding
$3 million in FY21 to the new maternal mental health hotline. This
funding will allow qualified counselors to staff a hotline 24 hours a
day and conduct outreach efforts on maternal mental health issues.
COVID-19 has exacerbated maternal mental health conditions at 3-4 times
the rate prior to the pandemic and leaving these conditions untreated
can have a long-term effects. We urge the Committee to provide $5
million to allow for the hotline to provide text messaging services,
culturally-appropriate support, and continue public awareness efforts.
Conclusion: March of Dimes looks forward to working with you and
all Members of Congress to secure the resources needed to improve our
nation's health. Federal public health programs are essential to
preventing preterm birth, ending preventable maternal deaths, and
addressing the maternal mental health that impacts mother, infants and
families.
______
Prepared Statement of Meals on Wheels America
Dear Chair Murray, Ranking Member Blunt, and Members of the
Subcommittee:
Thank you for the opportunity to submit testimony concerning Fiscal
Year 2022 (FY22) appropriations for the Older Americans Act (OAA)
Nutrition Program, administered by the Department of Health and Human
Services' (HHS) Administration for Community Living (ACL). On behalf of
Meals on Wheels America, the nationwide network of community-based
senior nutrition providers and the individuals they serve, we are
grateful for your ongoing support for the program, particularly in
response to the COVID-19 pandemic. With Congress' help in securing
much-needed emergency relief funding for the OAA network, local senior
nutrition programs (e.g., Meals on Wheels) continue to serve on the
front lines of the ongoing public health crisis, delivering essential
nutrition assistance and so much more to older Americans. Despite the
historic emergency supplemental funding and recent investments in
annual appropriations, senior nutrition programs continue to be
challenged by a soaring need for services which not only preexisted
COVID-19 but have been rendered far worse as a result of the pandemic.
For this reason, we request a total of $1,903,506,000 for the OAA Title
III C Nutrition Program--Congregate Nutrition Services, Home-Delivered
Nutrition Services, and Nutrition Services Incentive Program (NSIP)--in
FY22. As programs will continue to serve a greater number of older
adults through the new fiscal year and costs remain high, our specific
appropriations requests are:
--$965,342,000 for Congregate Nutrition Services (Title III C-1)
--$726,342,000 for Home-Delivered Nutrition Services (Title III C-2)
--$211,822,000 for Nutrition Services Incentive Program (Title III)
While this FY22 request is double the FY21-enacted funding levels
for the program, it reflects the amount necessary to maintain current
levels of service, while enabling the network to expand and adapt to
serve more seniors. As our country strives to respond, recover and
rebuild from the health and economic crisis, these nutrition programs
are a lifeline for millions of older adults and the services they
provide must flex to meet the need.
Overseen by ACL's Administration on Aging and implemented at the
local level through more than 5,000 community-based providers, the OAA
Nutrition Program delivers nutritious meals, opportunities for social
connection and safety checks to adults 60 and older--either in a group
setting or directly in the home--and has been at the forefront of
addressing senior hunger and isolation for nearly fifty years. Amid the
pandemic, older adults face unprecedented demands on their physical and
mental health, independence and financial well-being. The local
providers that serve them are seeing a far greater demand for their
services as operational expenses and/or overall costs to safely deliver
meals continue to rise. Accordingly, additional federal funding and
flexibility of use of OAA nutrition resources are needed for senior
nutrition programs to adequately adapt and expand operations to meet
the growing and evolving needs of the communities they serve.
Before the coronavirus pandemic, nearly 9.7 million (13%) older
adults ages 60 and older were threatened by hunger (i.e., marginally
food insecure)--5.3 million (7%) of which were food insecure or very
low food secure.\1\ Social isolation--which has been amplified amidst
safety and social distancing measures--is yet another threat for the
nearly 17.5 million (24%) seniors that lived alone in 2019.\2\ One in
five older adults reported frequent feelings of loneliness prior to the
pandemic, and many more seniors have experienced feeling lonely or lack
of social connection since then.\3\ Most older Americans possess at
least one trait that puts them at increased risk of experiencing food
insecurity, malnutrition, social isolation and/or loneliness, thereby
increasing the likelihood of experiencing myriad adverse health
effects. Despite the wide recognition of the relationship between
healthy aging and access to nutritious food and regular socialization,
millions of seniors were struggling to meet these basic human needs
pre-COVID; and these issues have only been exacerbated as a result of
the pandemic.
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\1\ J. Ziliak & C. Gundersen, The State of Senior Hunger in America
2018: An Annual Report, prepared for Feeding America, 2020. https://
www.feedingamerica.org/research/senior-hunger-research/senior.
\2\ U.S. Census Bureau, American Community Survey 2018, available
on the Administration for Community Living Aging, Independence, and
Disability Program Data Portal (AGID), 2020. https://agid.acl.gov/
CustomTables/.
\3\ AARP, Loneliness and Social Connections: A National Survey of
Adults 45 and Older, 2018. https://www.aarp.org/research/topics/life/
info-2018/loneliness-social-connections.htm.
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The OAA Nutrition Program is designed to reduce hunger, food
insecurity and malnutrition, and to promote socialization and the
overall health and well-being of older adults. Providers across the
country have long played a pivotal role in supporting the independence
and quality of life of the 2.4 million older adults they serve. Meals
served by the program must also meet the dietary guidelines set by the
OAA Nutrition Program and are often tailored to meet medical needs and
cultural preferences. OAA services are targeted toward seniors with the
greatest social and economic need-including those who are low-income;
are a racial or ethnic minority; live in a rural community; have
limited English proficiency; and/or are at risk of
institutionalization.\4\ For many program participants, the volunteer
or staff member who delivers meals to their homes may be the only
individual(s) she or he sees that day.
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\4\ Administration for Community Living (ACL), State Program
Reports 2019, available on AGID, 2021. https://agid.acl.gov/
CustomTables/.
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The profile of home-delivered meal clients reveals the high degree
of vulnerability among recipients, with the majority being age 75 or
older, female, living alone, taking multiple prescription medications
daily and/or having three or more chronic conditions. A significant
number of those served belong to a racial and/or ethnic minority group,
as 19% of participants are Black or African American, 7% are Hispanic
or Latino, and 5% are Native American or Hawaiian or Pacific Islander.
Additionally, among participants:
--35% live at or below the poverty level;
--25% live in rural areas;
--15% are veterans.\5\
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\5\ Mabli et al. Evaluation of the Effect of the Older Americans
Act Title III-C Nutrition Services Program on Participants' Food
Security, Socialization, and Diet Quality, Mathematica Policy Research,
report prepared for ACL, 2017. https://acl.gov/sites/default/files/
programs/2017-07/AoA_outcomesevaluation_final.pdf.
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A third (33%) of home-delivered meal recipients report not having
enough money to purchase food.\6\ Fortunately, the vital services
financed by the OAA Nutrition Program enable seniors with these risk
factors to remain safer, healthier and less isolated in their own homes
and communities.
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\6\ ACL. National Older Americans Act Participants Survey (NPS),
2018, available on AGID Custom Tables and NPS Data Files, 2020. https:/
/agid.acl.gov/.
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The results of a 2015 study commissioned by Meals on Wheels America
found that seniors who received daily home-delivered meals were more
likely to report improvements in mental health, self-rated health and
feelings of isolation and loneliness, as well as reduced rates of falls
and decreased concerns about their ability to remain in their home.\7\
Additional research has found home-delivered meal program participants
experience less healthcare utilization and lower expenditures than the
non-participant controls, suggesting the program's potential to reduce
costs among patients with high-cost or complex healthcare needs.\8\
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\7\ Meals on Wheels America. More Than a Meal Pilot Research Study,
report prepared by K. S. Thomas & D. Dosa, 2015, https://
www.mealsonwheelsamerica.org/learn-more/research/more-than-a-meal/
pilot-research-study.
\8\ Berkowitz et al. Meal Delivery Programs Reduce the Use of
Costly Health Care in Dually Eligible Medicare and Medicaid
Beneficiaries. Health Affairs (Vol. 37, No. 4), 2018. https://doi.org/
10.1377/hlthaff.2017.0999.
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Additionally, the OAA Nutrition Program is a true public-private
partnership that provides critical support and resources to local
community-based organizations. By serving seniors in their homes and
communities, local programs generate a powerful social and economic
return on investment for older adults and taxpayers alike. They
leverage funds granted to states through the OAA to offer nutrition and
social services with the help of millions of volunteers, who provide
innumerous in-kind contributions to support daily operations. In the
aggregate, funding from the OAA accounted for 40% of the total amount
spent to provide over 223 million congregate and home-delivered meals
in 2019, based on the latest available data.\9\ As public spending on
healthcare rises each year--largely attributable to a rapidly growing
senior population with complex health needs and disproportionate risk
to severe illness and complications due to COVID-19--it is imperative
that we invest in these cost-effective programs that safely promote
health and independence and reduce costly healthcare utilization among
many of our country's most at-risk seniors. To further underscore,
Meals on Wheels can serve a senior for an entire year for approximately
the equivalent cost of one day in the hospital or 10 days in a nursing
home.
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\9\ See note 4 above.
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Prior to the pandemic, federal funding for the senior nutrition
network was not keeping pace with increasing demand, rising costs and
inflation, leaving a huge gap between seniors served and those in need
of services but not receiving them. Nationally, the OAA Nutrition
Program network served 17+ million fewer meals in 2019 than in 2005--a
7% decline--despite the population of adults 60 and older growing 53%
over that same period.\10\ Further illustrating the need for more
funding, a 2015 Government Accountability Office study estimated that
83% of low-income, food insecure seniors do not receive the congregate
or home-delivered meals that they likely needed.\11\ Among Meals on
Wheels America members surveyed in 2019, nearly half of all local
programs reported maintaining an active waiting list due to
insufficient resources, and 85% of programs surveyed saw unmet need for
services in their communities at that time.\12\ The emergency funding
provided through COVID-19 relief legislation not only enabled programs
to provide services for those individuals in their communities who have
long been eligible and underserved but also helped address a huge
influx of older adults newly in need of nutrition services because of
the pandemic. An increase in FY22 appropriations is needed to ensure
that these individuals can continue to receive the nutritional and
social support unique to the OAA Nutrition Program that helps them
remain healthier and independent at home and out of far more costly
institutional or healthcare settings.
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\10\ ACL. State Program Reports 2005-2019, available on AGID, 2021.
https://agid.acl.gov/CustomTables/.
\11\ U.S. Government Accountability Office (GAO). Older Americans
Act: Updated Information on Unmet Need for Services, 2015. https://
www.gao.gov/products/GAO-15-601R.
\12\ Meals on Wheels America. More Than a Meal Comprehensive
Network Study, research conducted by Trailblazer Research, 2019.
www.mealsonwheelsamerica.org/learn-more/research/more-than-a-meal/
comprehensive-network-study.
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With the onset of the pandemic in March 2020, as mentioned above,
the Meals on Wheels network faced an unprecedented surge in demand as
the number of older adults sheltering in place increased and congregate
centers shifted ways of operating--including transitioning congregate
services to fully home-delivered or to grab-and-go and curbside pick-up
alternatives, as well as offering virtual socialization activities and
wellness checks over the phone. Most Meals on Wheels programs overcame
significant challenges to continue and then rapidly scale their
operations to serve more older Americans in need. In a survey conducted
in November 2020 on behalf of Meals on Wheels America, programs
reported delivering an average of 100% more home-delivered meals at
their pandemic peak than they served before.\13\ At that time, programs
also reported serving home-delivered meals to 84% more clients on a
weekly basis, and four out of five local programs agreed that these
``new clients are here to stay.''
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\13\ Meals on Wheels America. COVID-19 Impact Survey, research
conducted by Trailblazer Research, November 2020.
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Despite the incredible response from the senior nutrition network
to quickly scale services, barriers remain in addressing the full
demand. According to the November 2020 survey, 88% of Meals on Wheels
programs reported increased costs due to the necessary purchase of
personal protective equipment (PPE) and safety supplies, meal
production expenses and/or labor needs. Local programs reported that
costs are expected to remain high, and nine in 10 Meals on Wheels
programs reported unmet need for home-delivered meals in their
community. Nearly a third of programs said they would need to, at
minimum, double their home-delivered efforts to fill the gap in their
community, as many reported increased numbers of seniors forced to go
on waiting lists. More than 15 months into this public health crisis,
local programs are continuing to deliver these life-saving services at
high rates and have cited funding as the primary factor impacting their
ability to serve individuals most directly affected by the pandemic.
Without additional funding through the OAA, many nutrition providers
will not be able to support their current client base, much less expand
to reach more seniors who need services but are not receiving them.
We understand the difficult decisions you face with respect to
annual appropriations bills and other budgetary challenges as Congress
works to mitigate the impacts of the global pandemic and recover from
this prolonged national emergency. However, to address the current
level of nutrition services needed in communities, increased federal
funding through the regular appropriations cycle is critically needed
for the next fiscal year and beyond. With approximately 12,000
individuals turning 60 every day, the requested appropriations increase
will help provide the levels needed for community-based nutrition
programs to reach eligible older adults, especially as the demand for
these essential services continues to rise.
As the Subcommittee develops its FY22 Labor-HHS-Education
appropriation bill, we request you provide a minimum of $1,903,506,000
for the OAA Nutrition Program so that local community-based Meals on
Wheels programs can ensure the health, safety and social connectedness
of our nation's seniors, build the capacity of OAA programs and
services, and bridge the growing gaps and unmet need for services in
communities nationwide. Thank you for your leadership, support and
consideration. We look forward to working together to ensure that no
senior in America is left hungry and isolated.
[This statement was submitted by Ellie Hollander, President and
CEO, Meals on Wheels America.]
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Prepared Statement of the Medical Library Association and Association
of Academic Health Sciences Libraries
I, Mary M. Langman, Director, Information Issues and Policy,
Medical Library Association (MLA), submit this statement on behalf of
MLA and the Association of Academic Health Sciences Libraries (AAHSL).
MLA is a global, nonprofit, educational organization with a membership
of more than 400 institutions and 3,000 professionals in the health
information field. AAHSL supports academic health sciences libraries
and directors in advancing the patient care, research, education and
community service missions of academic health centers through visionary
executive leadership and expertise in health information, scholarly
communication, and knowledge management.
We thank the Subcommittee for the opportunity to submit testimony
supporting appropriations for the National Library of Medicine (NLM),
an agency of the National Institutes of Health (NIH), and recommend
$475 million for NLM in FY22, a 3% (+$12.9 million) increase. Working
in partnership with the NIH and other Federal agencies, NLM is the key
link in the chain that translates biomedical research into practice,
making the data and other results of research readily available to all
who need it. As NLM works to achieve key objectives of its Strategic
Plan--to accelerate data powered discovery and health, reach new users
in new ways, and prepare a workforce for a future of data-driven
research and health, it also supports NIH-wide efforts to answer the
call to respond to national priorities, close the gap in health
disparities, and capitalize on fundamental investments. NLM
accomplishes this through effective preservation of valued scientific
and data resources, judicious investments in extramural and intramural
research, informed stewardship of Federal resources, and innovative
partnerships to align priorities and leverage investments across HHS,
the Federal government, and the biomedical research community.
As health sciences librarians who use NLM's programs and services
every day, we can attest that NLM resources literally save lives.
Therefore, investing in NLM is an investment in good health.
Leveraging NIH Investments in Biomedical Research
NLM's budget supports information services, research, and programs
that sustain the nation's biomedical research enterprise. In FY22 and
beyond, NLM's budget must continue to be augmented to support
modernization and expansion of its information resources, services,
research, and programs which collect, organize, and develop new ways to
make readily accessible rapidly expanding biomedical knowledge
resources and data. NLM maximizes the return on investment in research
conducted by the NIH and other organizations. It makes the results of
biomedical information accessible to researchers, clinicians, business
innovators, students, and the public, enabling such data and
information to be used more efficiently and effectively to drive
innovation and improve health. Rapid growth of data also necessitates
funding that will ensure long-term sustainability of these valuable
information resources. NLM is unique because it stimulates and supports
innovative research in data science and information management that
transcends specific disease areas and data types.
NLM plays a critical role in NIH's data science and open science
initiatives leading the development, maintenance and dissemination of
key standards for health data interchange that are now required of
certified electronic health records (EHRs). NLM builds, sustains, and
augments a suite of almost 300 databases which provide information
access to health professionals, researchers, educators, and the public.
It supports the acquisition, organization, preservation, and
dissemination of the world's biomedical literature. In FY 2019, NLM
made genomic sequence data available in the cloud. NLM's Sequence Read
Archive (SRA) is the world's largest publicly available repository of
next-generation genome sequence data, with more than 9 million records
comprising 25 petabytes of data. To improve access and utility of SRA
data, NLM uploaded the public access SRA data to two commercial clouds
that have agreements with NIH's Science and Technology Research
Infrastructure for Discovery, Experimentation, and Sustainability
(STRIDES) Initiative. This transition significantly expands the
discovery potential of the data. Freed from the limitations of local
storage and computational resources, users are empowered to compute
across the full corpus of SRA data without having to download and store
large volumes of data. Moving to cloud platforms also makes it possible
to develop customized tools and methods for asking research questions
of the data.
Growing Demand for NLM's Information Services
Each day, more than 6 million people use NLM websites and download
115 terabytes of data. Thousands of researchers and businesses upload a
total of 15 terabytes of data daily. Annually, NLM information systems
process more than six billion human requests and eight billion
computer-to-computer interactions. NLM's information services help
researchers advance scientific discovery and accelerate its translation
into new therapies; provide health practitioners with information that
improves medical care and lowers its costs; and give the public access
to resources and tools that promote wellness and disease prevention.
Every day, medical librarians across the nation use NLM's services to
assist clinicians, students, researchers, and the public in accessing
information to save lives and improve health. Without NLM, our nation's
medical libraries would be unable to provide quality information
services that our nation's health professionals, educators, researchers
and patients increasingly need.
NLM's data repositories and online integrated services such as
GenBank, dbGaP, Genetics Home Reference (GHR), PubMed, and PubMed
Central (PMC) are revolutionizing medicine. GenBank is the definitive
source of gene sequence information. Each month, 2.1 million users
accessed consumer-level information about genetics from GHR, which
contains more than 2,700 summaries of genetic conditions, genes, gene
families, and chromosomes. PubMed, with more than 32 million references
to the biomedical literature, is the world's most heavily used source
of bibliographic information with almost 3.3 million users each day.
NLM also launched a new PubMed platform for an improved user
experience, including a new search algorithm with relevance rankings
and better tools for citations. PubMed Central is NLM's digital archive
which provides public access to the full-text versions of more than 6.8
million biomedical journal articles, including those produced by NIH-
funded researchers. On a typical weekday more than 3.5 million users
download articles from PubMed Central.
NLM continually expands biomedical information services to
accommodate a growing volume of relevant data and information and
enhances these services to support research and discovery. NLM ensures
the availability of this information for future generations, making
books, journals, technical reports, manuscripts, microfilms,
photographs and images accessible to all Americans, irrespective of
geography or ability to pay, and guaranteeing that citizens can make
the best, most informed decisions about their healthcare.
Disseminating Clinical Trial Information
ClinicalTrials.gov, the world's largest clinical trials registry,
now includes more than 370,000 registered studies and summary results
in all 50 states and in 219 countries for more than 48,000 trials. More
than 158,000 users access this vital information each day. As health
sciences librarians who fulfill requests for information from
clinicians, scientists, and patients, we applaud NIH and NLM for
implementing requirements for clinical trials registration and results
submission consistent with the FDA Amendments Act of 2007, and for
applying them to all NIH-supported clinical trials. These efforts
increase transparency of clinical trial results and provide patients
and clinicians with information to guide health care decisions. They
also ensure biomedical researchers have access to results that can
inform future protocols and discoveries.
Partnerships Ensuring Outreach and Engagement in Communities Across the
Nation
NLM's outreach programs are essential to the MLA and AAHSL
membership and to the profession. The NLM coordinates an 8,000-member
Network of the National Library of Medicine (NNLM), including 7
Regional Medical Libraries that receive NLM support, 125 resource
libraries connected to medical schools, and more than 5,000 libraries
located primarily in hospitals and clinics. Through the NNLM, NLM
educates medical librarians, health professionals, and the general
public about its services and provides training in their effective use.
The NNLM serves the public by promoting educational outreach for public
libraries, secondary schools, senior centers and other consumer
settings, and its outreach to underserved populations helps reduce
health disparities.
Since May 2018, the NNLM has partnered with the NIH All of Us
Research Program to support community engagement efforts by United
States public libraries and to raise awareness about the program.
Together, NLM and NIH have built the NNLM All of Us Community
Engagement Network (CEN). The CEN focuses on NNLM's mission to improve
the public's access to health information and provide awareness of All
of Us to communities that are Underrepresented in Biomedical Research
by partnering with libraries across the United States. The CEN is
designed to leverage the mission of the NNLM to help libraries in
supporting the health information needs of their users.
NLM's MedlinePlus provides consumers with trusted, reliable health
information on 1,000 topics in English and Spanish. It attracts more
than 1 million visitors daily. NLM continues to enhance MedlinePlus and
disseminate authoritative information via the website, a web service,
and social media. MedlinePlus and MedlinePlus en Espanol have been
optimized for easier use on mobile phones and tablets. NIH MedlinePlus
Magazine and NIH MedlinePlus Salud are available in doctors' offices
nationwide, and NLM's MedlinePlus Connect enables clinical care
organizations to link from their EHR systems to relevant patient
education materials.
Strengthening Data Science and Open Science Capacity
NLM is a leader in data science and open science, including the
acquisition and analysis of data for discovery and the training of
biomedical data scientists. The library aims to strengthen its position
as a center of excellence for health data analytics and discovery, and
to spearhead the application of advanced data science tools to
biological, clinical and health data. NLM is building a workforce for
data-driven research and health by funding PhD-level research training
in biomedical informatics and data science. The library also partners
with NIH to ensure inclusion of data science and open science core
skills in all NIH training programs, and is expanding training for
librarians, information science professionals, and other research
facilitators. NLM is participating in NIH-wide efforts to foster a
culture that advances science and ensures the development and retention
of a diverse, safe, and respectful workforce for data-driven research
and health well into the future.
Responding to the Novel Coronavirus (COVID-19)
The health sciences library community thanks Congress for providing
NLM with the $10 million supplemental appropriations to prevent,
prepare for, and respond to the Coronavirus. From the beginning, NLM
has been at the forefront of providing people with information on
COVID-19 . Our frontline health care providers use NLM's databases to
access the latest research datasets, literature publications, and
scientific information about Covid-19. NLM has responded to COVID-19's
rapidly evolving situation through its suite of tools and deep well of
expertise in managing large and complex datasets and making them
accessible to the public. Our frontline healthcare providers use NLM's
databases to access the latest research datasets, literature
publications, and scientific information about COVID-19. For example,
NLM has been:
--Making immediately available to the public in PubMed Central tens
of thousands of coronavirus-related research publication and
data contributed by major publishers
--Contributing to the COVID-19 Open Research Dataset (CORD-19), which
represents the most extensive machine-readable coronavirus
literature collection available for text mining to date, with
more than 30,000 full-text scholarly articles from PMC as of
mid-May 2020. The Text REtrieval Conference (TREC)-COVID
Challenge makes use of the CORD-19 dataset to help search
engine developers evaluate and optimize their systems in
meeting the needs of the research and healthcare communities.
--Creating BI SARS-CoV-2 Resources, a portal of literature, gene
sequence data, and clinical resources related to the virus that
causes COVID-19.
--Providing the biomedical community free and easy access to genome
sequences from the coronavirus through the GenBank sequence
database.
--Providing information about US clinical trials related to COVID-19
via ClinicalTrials.gov, which is also now making available
information about trials listed in the World Health
Organization's international clinical trial registry.
--Extending standard terminologies to include terms related to COVID-
19, including codes for laboratory tests, chemical entities,
and indexing terms.
--Applying machine learning techniques to research conducted at NLM
to assist in identifying COVID-19 in X-rays and to identify and
categorize relevant published literature.
Supporting Biomedical Informatics Research and Health Information
Technology Innovation
NLM conducts and supports informatics research, training and the
application of advanced computing and informatics to biomedical
research and healthcare delivery. NLM's National Center for
Biotechnology Information (NCBI) focuses on genomics and biological
data banks, and the Lister Hill National Center for Biomedical
Communications (LHC), is a leader in clinical information analytics and
standards. Many of today's biomedical informatics leaders are graduates
of NLM-funded informatics research programs at universities nationwide.
A number of the country's exemplary electronic and personal health
record systems benefit from findings developed with NLM grant support.
A leader in supporting the development, maintenance, and free,
nationwide dissemination of standard clinical terminologies, NLM
partners with the Office of the National Coordinator for Health
Information Technology to support the interoperability of EHRs. NLM
also develops tools to make it easier for EHR developers and users to
implement accepted health data standards and link to relevant patient
education materials. In FY 2019, NLM played a critical role in the
development, usage, and utility of a data exchange standard to improve
flow and availability of data, the Health Level Seven International
(HL7) Fast Healthcare Interoperability Resources (FHIR(r)). NIH is
encouraging funded investigators to use the FHIR standard to capture,
integrate, and exchange clinical data for research purposes and to
enhance capabilities to share research data. NIH has also announced to
the small business communities its special interest in supporting
applications that use FHIR in the development of health IT products and
services. To support these efforts, NLM is managing the development and
testing of FHIR tools that researchers can use to increase the
availability of high-quality, standardized research datasets and
phenotypic information for genomic research and genomic medicine.
Closing the Gap in Health Disparities
The National Library of Medicine supports NIH's efforts to close
the gap in health disparities and improve the diversity of the
biomedical information science workforce. Their work supports our
mission and core values to make MLA and AAHSL more diverse and
inclusive organizations. NLM accomplishes this by:
--Providing open access to scientific literature through PubMed and
PubMed Central make scientific literature accessible, lading to
biological discoveries and providing the foundation to
developing clinical guidelines that inform health care.
Resources include PubMed Special Query for Health Disparities
and Minority Health Information Resources.
--Utilizing the Network of the National Library of Medicine to
provide equal access to biomedical information and improves the
public's access to information. NNLM supports events including
the recent DEI webinar series ``Nine Conversations that Matter
to Health Sciences Librarians'' as well as NNLM Reading Clubs
on Disability Health, LGBTQ Health, Racism and Health and
Diversity in Medicine.
--Funding grant programs that support research to advance health
equity and grants to reduce health disparities research
supplements to promote diversity in health research and
leveraging health information technology to address minority
health and health disparities.
--Raising awareness and sparking conversations about the intersection
of society and ethical considerations in biomedical research
and technology through the annual NLM Science, Technology, and
Society lecture series.
We look forward to continuing this dialogue and thank you for your
efforts to support funding of at least $475 million for NLM in FY22,
with additional increases in future years.
______
Prepared Statement of the METAvivor Research and Support, Inc.
fiscal year 2021 appropriations recommendations
_______________________________________________________________________
--Please provide the National Institutes of Health (NIH) with an
increase of at least a $3.2 billion for FY 2022 to bring total
agency funding up to a minimum of $46.1 billion annually.
--Please support establishment and adequate funding for the new
Advanced Research Projects Agency for Health (ARPA-H) at
NIH as proposed in the Administration's Budget Request to
Congress to facilitate robust scientific progress on
cancers.
--Please continue to support additional investment for the cancer
``moonshot'' as outlined by the 21st Century Cures Act and
otherwise ensure the National Cancer Institute (NCI) has
adequate resources.
--Please continue to emphasize the importance of federal research
activities focused on controlling and eliminating cancer that
has already disseminated (Metastatic Cancer) through committee
recommendations and timely oversight of ongoing activities.
--Please support emerging efforts to modernize the Surveillance,
Epidemiology, and End Results Research Program (SEER) Registry
to better capture the experience of metastatic cancer patients
(as outlined by recommendations within the FY 2021 Senate LHHS
Appropriations Bill).
_______________________________________________________________________
Chairwoman Murray, Ranking Member Blunt, and distinguished members
of the Subcommittee, thank you once again for considering the views of
METAvivor and the stage IV metastatic cancer community as you work on
FY 2022 appropriations for medical research and public health. The
community is deeply grateful for the sustained investment in NIH, and
emerging calls for a robust and comprehensive effort to enhance cancer
research. Please maintain the commitment to supporting innovative
medical research and providing adequate resources to public health
programs moving forward, for FY 2022.
about metavivor
My name is Jamil Rivers. I had a typical family before my diagnosis
of ``de novo'' metastatic breast cancer. I was 39 years old, married,
with three children and a full-time job. We were very active and always
doing something. I have a big, tight-knit family and we love to travel.
I had just changed jobs and we moved into a new house. I never missed a
beat--and then my husband was diagnosed with stage-one colon cancer. I
became his caregiver. It was in 2017, and everyone got sick in the
wintertime like we always do. We had colds and were coughing, but my
cold didn't go away. I also had this pain and this pinch, like I had
pulled a muscle on my right side. When I went to the doctor about my
cold and cough, they had prescribed me antibiotics. I also asked for an
ultrasound because appendicitis runs in my family. The results showed
that I had lesions in my liver. I had no other symptoms and no other
pain, but further testing showed I had stage IV ``de novo'' metastatic
breast cancer. It was the most shocking news ever.
The breast cancer had spread to my liver, my spleen, lymph nodes,
lungs, bones, my abdomen and my chest wall. I was devastated. I'm
blessed with this beautiful family and my kids are really young. At the
time they were only 5, 6 and 16 years old. Why would God bless me with
this beautiful family and then strip me from them? I couldn't wrap my
brain around the fact that my husband and I could both have a serious
health issue. It just wasn't a possibility.
``Who is going to take care of our kids?'' That was the first thing
I thought about in the midst of my devastation. But after that, I
realized I had to survive for them; I have to be here for them. I
wanted my kids to know that I did everything I could possibly do in my
power to be here for them. I had to process my diagnosis so I could
focus on my health. You never think this could happen to you but it
did. It happened to me.
I'm the type of person who, when a challenge is brought to me, I
figure out how to execute it and get it done. I basically had to figure
out. I empowered myself and armed myself with as much knowledge,
information, resources and support as possible. My mission was
survival.
I'm my kids' mom and no one else can be. I'm the breadwinner in my
family and everyone is also on my benefits. It was imperative that I
keep my job and do well at my job so I could continue to take care of
them. I started chemotherapy right away because, on paper, I was
literally dying. The kids had to see me lose all of my hair and be
really tired. That's when I started researching what else I could do in
terms of integrative therapy to help me manage the side effects of the
chemo in order to still work, be active and take care of my kids the
same way I always had.
Now, my husband is in recovery and after 1 year of chemotherapy, my
tumors have shrunk to the point where they're a microscopic size so you
can't see them on a scan... also known as ``no evidence of disease''.
I'm still working, taking care of the kids and involved in their school
activities. I want to soak in every waking second with my family.
I'm not giving up anytime soon.
Through my advocacy, I have tried to help bring more attention to
metastatic breast cancer, the need for more research funding and
investment towards metastatic breast cancer. I now serve as Board
President of METAvivor and work alongside others to push this important
work forward. I hope the lives of the more than 600,000 people with
stage IV metastatic cancer is considered when making decisions about
the future of cancer research and especially funding the stage IV
metastatic cancer research. METAvivor has worked hard to fund research.
Since 2009, we have funded over $18 million but we need more...stage IV
metastatic cancer needs more research.
the facts about metastatic stage iv cancer
Roughly 600,000 Americans die annually from cancer. Ninety percent
of these deaths are caused by a metastasis. If we wish to lower the
death rate, we must tackle metastasis. For more than 20 years, the
primary focus has been on preventing cancer altogether and if that
fails, catching it early. But aside from convincing people to stop
smoking, forbidding smoke in common areas and removing colon polyps
prior to malignancy, little progress has been made. For most cancers,
it is believed there are multiple causes, few if any of which are
known, making prevention a formidable goal. Improved equipment has
allowed some cancers to be diagnosed as early as stage 0; however,
stage 0 patients are also metastasizing. And although we are slowly
adding drugs to the treatment repertoire, a treatment's effectiveness
often runs out in 2-3 months. Thus, we empty our toolbox of drugs far
too quickly and we, metastatic patients, die. Saving lives is an
achievable goal but tragically is not being realized because the focus
continues to be prevent and early detect. Those goals have been
maximized. Backs have been turned to the metastatic community long
enough. It is high time to include metastasis as a major focus area.
Sarah, Oregon
My name is Sarah Wald. I live in Eugene, Oregon. I am a professor
at the University of Oregon and a parent. I'm also living with
metastatic breast cancer. I was diagnosed with metastatic breast cancer
just over two years ago. It was a denovo diagnosis. This means I was
Stage IV at diagnosis. It was not a recurrence. I have no family
history of breast cancer. I saw my doctor annually for breast exams and
planned to start mammograms at forty. I had no symptoms at diagnosis. I
felt healthy. I biked 50 miles the weekend after I found what felt like
an immobile small grape in my breast. I called my doctor the morning
after I found the lump and took the first available appointment. She
got me in for a mammogram and ultrasound the day I saw her. It was
already too late. There were breast cancer cells in my bones.
I don't know how to explain to you what it is like to find out you
are dying of a terminal disease in your thirties. I don't know how to
explain to you what is like to feel healthy and be looking forward to
the future with your family and then to be told that you will almost
certainly be dead in the next few years. There is nothing I want more
than to live. I want every day of life that I can have. I want every
extra week I can spend with my family. I want to see the flowers come
in and bloom every spring. We need money for research. I was shocked to
find out how little money actually goes to metastatic breast cancer
research when it is metastatic breast cancer that kills. For those of
us living with the disease, it is a race against time to find new
treatments that will give us those extra months and those extra days.
New research and new treatments make a difference. For the past two
years, my cancer has been controlled by a treatment that first received
FDA approval in 2015. My second line of treatment will contain a drug
that received FDA approval after my diagnosis in 2019. The research you
fund today might be the research that lets me see another birthday,
mine or my child's. We need to find out how to stop breast cancer from
metastasizing and treat it when it does. I don't want anyone else to go
through what I am enduring. Please support funding more research for
stage IV metastatic breast cancer.
[This statement was submitted by Jamil Rivers, Board Chair,
METAvivor
Research and Support, Inc.]
______
Prepared Statement of the Michelson Center for Public Policy
The Michelson Center for Public Policy (MCPP) thanks the
Subcommittee for its long-standing bipartisan leadership in support of
the National Institutes of Health (NIH). Robust support for science and
innovation is critical if we are to advance public health, sustain U.S.
leadership in medical research, and remain competitive in today's
innovation economy.
It is now estimated that the COVID-19 pandemic will cost the U.S.
economy more than $16 trillion.\1\ The NIH's fiscal year (FY) 2021
budget was just 0.25 percent of that. The NIH is the world's largest
funder of medical research and the basic, clinical, and translational
research that it funds is the very fuel that feeds the American engine
of discovery and drives innovation in pharmaceuticals and
biotechnology. More importantly, NIH research saves lives and improves
wellbeing for millions worldwide. Now is the time to vaccinate the
economy and bolster our ability to respond to the emerging public
health threats of tomorrow by continuing to invest heavily in
biomedical research with transformative potential. MCPP urges the
Subcommittee to provide $100 billion for NIH in FY 2022.
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\1\ https://news.harvard.edu/gazette/story/2020/11/what-might-
covid-cost-the-u-s-experts-eye-16-trillion/.
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MCPP is a 501(c)(4) social welfare organization that propels
legislative change through meaningful collaboration with elected
officials, government agencies, and civic leaders to achieve positive
outcomes in medical research, education, equity, and animal welfare.
The Michelson Center for Public Policy is an affiliated but separate
organization from the Michelson Philanthropies network of foundations
(Michelson 20MM Foundation, Michelson Found Animals Foundation, and
Michelson Medical Research Foundation) and complements the Michelson
Philanthropies' thought leadership and expertise with bold and
effective advocacy.
MCPP's founder and co-chair is physician, inventor, and
philanthropist Gary Michelson, M.D. He is committed to using his
platform to advocate for robust investment in biomedical research,
disruptive innovation that can deliver more treatments and cures, and
support for the next generation of researchers.
Through the Michelson Medical Research Foundation, Dr. Michelson
makes grants to support high-quality, cutting-edge medical research
because a single breakthrough could benefit the lives and health of
hundreds of millions. But philanthropy cannot do it alone. Truly
transformative medical advances are seeded by robust investment in the
NIH and these investments have exponential returns for the economy,
jobs, tax revenues and--most importantly-humankind.
MCPP is thankful for the strong bipartisan support that the
Subcommittee leaders, Chairwoman Rosa DeLauro and Ranking Member Tom
Cole, have shown in providing the NIH with six consecutive funding
increases during this time of constrained budgets. These increases have
helped the NIH regain ground from the years of largely flat funding in
inflation-adjusted dollars. However, we must do more.
The Biden Administration has proposed to fund the NIH at $51
billion in 2022, which is a good start, but not nearly enough. This is
precisely the right time to be bold and go bigger. For the NIH to
invest adequately in risky research with the most promise for
transformative advances--the very type of research that enabled the
unprecedented COVID-19 vaccine development we saw over the past year-it
needs twice that.
We cannot afford to be modest in our efforts. No one deserves to
fall ill and die, or to helplessly watch as their child, parent or
spouse suffers because we failed to do the work right now to save them.
We must dramatically increase the NIH's budget, so that a lack of
funding is not the reason why patients go untreated and diseases remain
a threat to public health.
The COVID-19 pandemic has shown that the NIH cannot only rely on
incremental annual increases to its base budget to meet the next public
health challenge. A fraction of the resources put into combating the
pandemic should have been invested in the NIH years ago. With impacts
like $16 trillion from one pandemic, we need more than inflationary
increases to NIH each year to keep pace and inoculate the country
against the next public health crisis.
Investing in the NIH is an investment in our national security. The
investments that protect our nation's health and wellbeing should be
protected in the same manner as investments in our national defense.
Not only is NIH research essential to advancing health and national
security, it also plays a key economic role. Funds provided to NIH are
not costs, but instead generate remarkable rates of economic return and
even greater returns on our health and wellbeing. In FY 2020, NIH
invested $34.65 billion, or almost 80 percent of its budget, in the
biomedical research industry across the country. This investment
supported more than 536,338 jobs nationwide and generated nearly $91.35
billion in economic activity across the U.S.\2\ Just one NIH-funded
medical research program, The Human Genome Project, directly generated
more than a trillion dollars for the US economy--a 178-fold return on
investment--and has paid for itself many times over in industry tax
revenues returned to the government.\3\
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\2\ NIH's funding information and economic impact data comes from
United for Medical Research's 2021 State-By-State Update, https://
www.unitedformedicalresearch.org/wp-content/uploads/2021/03/NIHs-Role-
in-Sustaining-the-U.S.-Economy-FINAL-3.23.21.pdf.
\3\ https://www.nih.gov/about-nih/what-we-do/impact-nih-research/
our-society.
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MCPP is enthusiastic about the Biden Administration's proposal to
establish a new Advanced Research Projects Agency for Health (ARPA-H).
As proposed, ARPA-H could drive innovation and accelerate the
development of innovative therapeutics, treatments, and cures for
chronic conditions such as cancer, diabetes, and Alzheimer's Disease.
Too often, research supported by the NIH results in incremental
advancements and not the transformative scientific breakthroughs that
only come from robust investment in high-risk high-reward research.
MCPP is committed to supporting innovative ideas that can accelerate
the pathway to cures. Standing up an entity like ARPA-H that is focused
on high-risk high-reward research and accelerating the timeline from
idea to clinical application is the exact thing our nation needs to
leverage the lessons learned from the COVID-19 pandemic and apply them
to other pressing public health challenges.
A crucial component of ensuring that the NIH is equipped to meet
the health challenges of the future is supporting the next generation
of scientists. Early career researchers in the biomedical sciences face
many struggles as they move toward independence. Lack of independent
funding opportunities and tenure-track faculty positions place many
early career researchers in a cycle of training positions that may
hinder growth, innovation, and scientific independence. In addition,
the NIH funding ecosystem is harmfully ``hypercompetitive.'' In 2020,
only one out of every five applicants was ultimately awarded NIH
funding, and the resulting grant was almost always less than the amount
requested to effectively perform the research. This system especially
disadvantages early career investigators, squandering the potential of
scientists with groundbreaking and innovative ideas.\4\ Furthermore,
among early career researchers, women, parents, and those from
underrepresented backgrounds in STEM bear a disproportionate amount of
this burden. MCPP urges the Subcommittee to build NIH's ability to
devote more of its annual budget to programs that support early career
researchers, with the goal of attaining ten percent of the agency's
overall budget invested in the most promising young investigators
conducting highly innovative research with truly transformative
potential.
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\4\ https://nexus.od.nih.gov/all/2018/05/04/the-issue-that-keeps-
us-awake-at-night/.
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MCPP thanks the Subcommittee for its important work dedicated to
ensuring the health and security of the nation, and we appreciate this
opportunity to urge the Subcommittee to continue the success of NIH by
providing at least $100 billion in FY 2022. This is the minimum amount
needed to transform our nation's investment in life-saving medical
research, enhance NIH's ability to support highly innovative and
groundbreaking research, and expand support for young investigators.
We have a once-in-a-lifetime opportunity to pave the way for future
medical advances to benefit humankind. Let's seize it.
______
Prepared Statement of the Midwest Urban Strategies
Dear Chairman Murray and Ranking Member Blunt:
Midwest Urban Strategies (MUS) represents a coordinated effort on
behalf of 13 Department of Labor urban workforce development boards to
connect traditional workforce development practices with economic
development. Our member organizations are directly involved in the
implementation of the bipartisan Workforce Innovation and Opportunity
Act (WIOA) of 2014, specifically promoting the successful execution by
local workforce boards of the law to serve businesses, employers, and
job--and career-seekers. The economic recession and recovery caused by
COVID-19 is unlike any other period is our nation's history. MUS
members, along with local workforce development boards across the
country, immediately adapted to continue to provide critical supports
and services to job seekers and businesses throughout the pandemic. Our
methods may have changed given the circumstances, but the impact of our
work persisted, no matter the obstacle.
As the Senate Appropriations Committee considers the Fiscal Year
(FY) 2022 Labor-HHS Appropriations Bill, we urge you to support further
federal investment into WIOA and fully fund the law beyond its FY2020
authorized levels. We strongly support the proposed funding levels in
President Biden's FY 2022 Budget as it recognizes that appropriated
levels have fallen short of authorized levels specifically in Title I
accounts at the Department of Labor (Adult Employment and Training
Services, Youth Workforce Investment Activities, and Dislocated Worker
Employment and Training Services).
Additional federal resources for WIOA programs lead to more job
training, education, skills development and innovative, proven
practices like industry-based sector partnerships, career pathways, and
apprenticeships. MUS works collaboratively in our region and across the
country to advance these best practices. Workers and entire industries
have been severely disrupted as a result of COVID-19 and these
strategies will need to be implemented seamlessly to respond. The
established local workforce system is well-positioned to enhance
efforts for an equitable recovery; low wage, low skill workers and
minority populations were hit hardest by COVID-19. The federal funding
structure, which allows these funds to be invested locally, provides
for intentional investments to help those most in need.
Local workforce development leaders engage directly with businesses
to keep individuals employed and design training/education programs to
prepare the workforce for the future. We continue to work with
unemployed individuals to re-connect them to the workforce and identify
and evaluate other opportunities; recent BLS data suggests nearly 41%
of those unemployed have been unemployed for at least 27 weeks (long-
term unemployed).\1\ Business services, especially for small and
medium-sized enterprises, have been critical during the COVID-19
pandemic as employers sought to maintain payrolls and find workers as
businesses began to re-open. Increased federal appropriations are
greatly needed to address this unprecedented health, economic, and
social destabilization.
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\1\ https://www.bls.gov/charts/employment-situation/unemployed-27-
weeks-or-longer-as-a-percent-of-total-unemployed.htm.
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The Fiscal Year 2022 Labor, Health and Human Services, Education,
and Related Agencies Appropriations bill must fully fund all Titles--I,
II, III, and IV--at a minimum to the level authorized by the Workforce
Innovation and Opportunity Act (WIOA).
The funding levels we are requesting in the FY2022 Labor, HHS,
Education Appropriations Bill are listed below:
Title I--Department of Labor
--At least $899.987 million for Adult Employment and Training
Services,
--At least $963.837 million for Youth Workforce Investment
Activities, and
--At least $1.436 billion for Dislocated Worker Employment and
Training Services
Title II--Department of Education
--$678.640 million for Adult Education
Title III--Department of Labor
--$692,370,000 for Wagner-Peyser (FY2021 Enacted)
Title IV--Department of Education
--$3,675,021,000 for Vocational Rehabilitation Services (FY2021
Enacted)
This training, support and business partnership is vital to our
country's economic prosperity. For further information, please contact
Tracey Carey.
Sincerely.
[This statement was submitted by Tracey Carey, Executive Director,
Midwest Urban Strategies.]
______
Prepared Statement of the Moore Center for the Prevention of
Child Sexual Abuse
The Moore Center for the Prevention of Child Sexual Abuse at the
Johns Hopkins Bloomberg School of Public Health (Moore Center) welcomes
the opportunity to submit this statement for the record about the
importance of federal investment in child sexual abuse prevention
research. The Moore Center was founded in 2012 on the premise that
child sexual abuse is a preventable, not inevitable public health
problem. Our mission is to create, through rigorous science, a public
health approach to preventing child sexual abuse. Together with many
stakeholders in the child welfare community, the Moore Center requests
that Congress appropriate $10 million for child sexual abuse prevention
research at the Centers of Disease Control and Prevention's National
Center for Injury and Violence Prevention, Division of Violence
Prevention in FY 2022.
Child sexual abuse and the damage it causes to children, adults,
families, and communities too often makes headlines. Astoundingly,
approximately 13 percent of all children will become victims of the
crime. Child sexual abuse is associated with serious mental and
physical health problems that shorten the lifespan and reduce its
quality. Effects include increased risk for post-traumatic stress
system disorder, substance use disorders (including opioid abuse), HIV,
heart disease, and suicide. Given this, it is no surprise that our 2018
study found that the economic burden of child sexual abuse was $9.3
billion in 2015, and costs each victim more than $280,000 in earning
and other losses over their lifetime.\1\
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\1\ Letourneau, Elizabeth J., et al. ``The Economic Burden of Child
Sexual Abuse in the United States.'' Child Abuse & Neglect, vol. 79,
2018, pp. 413-422., doi:10.1016/j.chiabu.2018.02.020.
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The COVID-19 pandemic has further underscored the need for
effective prevention programming. The National Center for Missing and
Exploited Children reported an almost 100 percent increase in online
enticement reports and a 63 percent increase in CyberTipline reports
between January and September 2020, compared to the same months in
2019. Additionally, the International Criminal Police Organization
reported increased consumption of child sexual exploitation and abuse
materials among several member countries during the pandemic. In
addition to increased online offending, data from US and UK Stop it
Now! helplines and websites indicate a surge in requests for help by
people concerned about their own sexual thoughts and behaviors,
particularly stepfathers with sexual thoughts about their
stepdaughters. These increases are likely due to steep pandemic-related
job losses and work-from-home/learn-from-home policies that leave at-
risk men who were previously managing their urges with too much time,
too much access to children, and too little structure. We expect risk
for online and intra-familial offending will remain high until pre-
pandemic employment and in-school education levels are regained.
The federal government rightly funds treatment and other services
for crime victims, including victims of child sexual abuse, and funds
criminal justice efforts to detect, prosecute and hold accountable
those who commit child sexual abuse. Indeed, the federal government
annual spends approximately $529,000,000 solely to incarcerate people
with sex crimes against children in federal facilities. Yet 95 percent
of all sex crimes are committed by people with no prior sex crime
convictions. As important as victim and criminal justice efforts are,
they do little if anything to prevent harm from occurring in the first
place. An inadequate focus on preventing child sexual abuse stands in
stark contrast to robust federal efforts that address all other forms
of child victimization as preventable public health problems and not
solely criminal justice programs. For decades, we have supported the
development, validation, and dissemination of programs such as home
visitation that effectively prevent child physical abuse and neglect,
as well as school-based programs that effectively prevent peer-on-peer
bullying, teen dating violence, and suicide. The lack of similar
strategies to prevent child sexual abuse is primarily due to the
failure to fund similar research in this space.
In the absence of validated prevention efforts, organizations and
individuals that work with children have had to develop and implement
idiosyncratic and untested prevention efforts. Youth serving
organizations, schools, religious groups, sports clubs, after-school
programs, child care settings, hospitals, and other youth-focused
organization have to create and recreate their untested prevention
strategies. Indeed, most states mandate that child sexual abuse
curricula be implemented in K-12 schools, yet few such programs have
been tested for their effectiveness. There is no way to tell if any
given prevention effort might be effective, ineffective, or even
harmful to children in the absence of evaluation.
The FY 2019 appropriations bill directed the CDC to release a
report on the current state of child sexual abuse prevention research.
The report, released in December 2019, outlines significant gaps in
existing research efforts, which include the need to: improve
surveillance systems and data collection; increase the understanding of
risk and protective factors; and, strengthen, develop and disseminate
evidence-based prevention policies, programs and practices.
In FY 2020 $1 million was allocated to the CDC's Division of
Violence Prevention, which funded two grants to study adult child
sexual abuse perpetration prevention. The Moore Center was a recipient
of one of these grants, which is being used to conduct research to
validate our Help Wanted intervention, an online prevention program
designed to provide individuals with sexual interest in younger
children with the support and resources to maintain their commitment to
non-offending. Virginia Commonwealth University was the recipient of
the other grant, which will be used to evaluate Praesidium's Armatus(r)
Learn to Protect program, a program focused on the prevention of school
employee-perpetrated child sexual abuse, misconduct, and exploitation
of students.
In FY 2021 child sexual abuse prevention research received a
$500,000 increase. In response, the CDC published a funding opportunity
announcement for proposals to evaluate approaches on primary prevention
of child sexual abuse perpetrated by youth or adults. The Moore Center
was very appreciative for this increase and recognizes the difficulty
that the budget caps created for giving programs funding increases;
however, it is critical that additional funding is allocated in FY 2022
to address the aforementioned research gaps identified by the CDC. We
believe that a $10 million appropriation would allow for meaningful
advances to be made in the successful prevention of child sexual abuse.
We want all American children to grow up free from abuse; federal
investment in child sexual abuse prevention research is needed to make
this wish a reality. The foundation and philanthropic community
currently supporting prevention research and evaluation cannot continue
to fund it alone. We urge you to include $10 million for research on
the primary prevention of child sexual abuse at the CDC as funding
priority for FY 22.
We look forward to working with the committee on efforts to protect
our children from child sexual abuse and hope that you will consider
the Moore Center a resource in the future. Thank you in advance for
your time and consideration.
[This statement was submitted by Elizabeth J. Letourneau, Ph.D.,
Director, Moore Center for the Prevention of Child Sexual Abuse.]
______
Prepared Statement of NAF
NAF is a national network of education, business, and community
leaders who work together to ensure high school students are college,
career, and future ready. NAF appreciates the opportunity to submit
testimony to the Senate Labor, Health and Human Services, Education,
and Related Agencies (LHHS) Appropriations Subcommittee regarding our
request for Fiscal Year 2022 report language for a Work-based Learning
Coordinators Demonstration Program funded at $5,000,000 at the
Department of Labor's Employment and Training Administration.
NAF's educational design promotes open enrollment in our career
academies and allows students of all backgrounds and capabilities to
participate. The design is replicable, sustainable, and cost-effective,
and because it integrates within public schools, supports lasting
systemic reform and equity nationwide. NAF transforms the learning
environment to include STEM-infused, industry-specific curricula and
work-based learning experiences. NAF serves more than 117,000 students
in 34 states, Washington D.C., Puerto Rico, and the U.S. Virgin
Islands. NAF is focused on helping to eliminate systemic, educational,
and professional barriers faced by students of color.
Economic upheaval from the pandemic will negatively affect the
young people entering the workforce at a time when communities need
talented workforce to aid in the recovery. It is even more challenging
for students of color and from low-income communities with systemic
inequities who will face lower earnings, less overall wealth, and
greater economic consequences.
Public secondary education institutions play a critical role in
preparing youth for future success through initiatives like career and
technical education programs, access to local colleges, and work-based
learning opportunities with employers. As a principal public
institution that young adults go through before becoming adults, the
secondary education system plays a significant role in setting up the
next generation for success in the workforce. Work-based learning
programs ensure a connection between schools and the working world,
whether it's preparing students to enter existing jobs, encouraging
entrepreneurial endeavors, or serving as a foundation for career
opportunities after post-secondary education.
Work-based learning is the continuum of activities both in
classroom learning and the actual workplace setting that leads students
to gain real world experience. It also has proven economic benefits for
Black and Latinx students and young people from families with low
incomes. Through work-based learning, virtual and in-person, students
can better identify their career interests and aptitudes, understand
the education and training they need to achieve their aspirations, and
build their professional and support networks.
The most effective work-based learning experiences provide
sustained and meaningful interaction between a student and employer
partner. This would include career preparation activities such as
internships, apprenticeships, and mentorship programs. While less
intensive activities--such as guest speakers, mock interviews, and
worksite tours--are important to help students with career awareness
and exploration and to introduce employers to the concept of work-based
learning, the more time--and resource-intensive activities like
internships are where students gain the most insight into the working
world and are able to hone their professional skills.
When created with intentional student learning outcomes and
ownership by all stakeholders, work-based learning can shape students'
aspirational opportunities by helping them explore potential careers of
interest; build student skills; and help level the playing field by
exposing students to networking opportunities to build a diverse
professional network, which research indicates is particularly
transformative for students of color and those from low-income
households.
Further, 80% of jobs are filled through personal and professional
connections. Work-based learning helps students build these
relationships and expand their networks beyond their immediate
communities. The relationships with adults nurtured through work-based
learning opportunities are also shown to be long-lasting, positively
benefiting students up to a decade later. Young people deserve an
education that builds workforce-ready skills, helps them create social
capital, and connects them to opportunity. This is true in ``normal''
economic times and even more critical during a downturn.
Engaging high school students in work-based learning experiences
ensures these students graduate college, career, and future ready,
which is essential, especially for students who fail to see the
connection between high school academics and future careers. In a
recent study, students enrolled in a NAF program in grade 9 and were
identified as at-risk of not graduating were 5 percentage points more
likely to graduate from high school than their non-NAF counterparts.
NAF academy students have a 99% graduation rate.
Educators often have the challenge of finding time to plan and
implement work-based learning due to their lack of staffing capability
to this particular initiative. With so many demands on school staff,
work-based learning is seen as supplementary and not a priority.
Administrators and teachers who have accountability testing
requirements also push back on the amount of time this strategy
requires outside of the classroom. These educators may lack the
capacity to meaningfully engage employers and develop sustainable
relationships.
Work-based learning coordinators can bridge the divide between
school and community employers. The coordinators support work-based
learning programs by assisting schools and districts with strategic
program planning, coordinating work-based learning activities, and
building relationships with employer partners to increase access to
internships and other career-focused activities.
NAF encourages schools and communities to have work-based learning
coordinators as we have seen it make a difference in the quality and
quantity of experiences for students. NAF urges the subcommittee to
support and advocate for the inclusion of the following report language
in the Fiscal Year 2022 Appropriations bill.
Research shows that participation in work-based learning during
high school has a positive impact on students, including completing
high school, and helps them secure higher-quality jobs, boosting equity
and economic opportunity. To build upon Congress' request of the
Department in Fiscal Year 2021 to encourage local secondary education
authorities be included on local workforce development boards, the
Committee recommends $5,000,000 in Fiscal Year 2022 for the first year
of a five-year demonstration program to provide full-time, work-based
learning coordinators in underserved communities with an already proven
track record for secondary career and technical education. Work-based
learning coordinators to conduct outreach, engagement, recruitment and
coordination of work-based learning activities, including, but not
limited, to paid internships or pre-apprenticeships for high school
students, with local community employers, especially with in-demand
industries of information technology, health sciences, and engineering.
The work-based learning coordinators may be employed by the local
education agency, local workforce development board or local workforce
development agency, a group of employers, or a consortium of eligible
entities. In making grant awards, the Committee directs the Secretary
to ensure to require a plan for evaluations in each individual grant
proposal, including types of work-based learning opportunities
completed, demographics of participating students, and students' post-
secondary career plan, as well as to conduct a national assessment of
all grantee proposals once complete.
conclusion
Though our world is changing rapidly, and we face unprecedented
challenges; we have an opportunity to pave the way for a stronger and
more equitable economy. Work-based learning, including paid
internships, is a proven, effective way to ensure high school students
are college, career, and future ready and prepared to meet the demands
of an evolving economy. NAF appreciates the opportunity to share its
expertise; and thanks you for your consideration of this important
request.
______
Prepared Statement of the National Alliance for Caregiving
Chair Murray and Ranking Member Blunt, and members of the
Subcommittee, thank you for your tireless efforts during the COVID-19
pandemic to ensure that older adults, people with disabilities, and
their caregivers across the nation could access the supports and
services that they needed to survive. As you know, during our historic
collective crisis, Older Americans Act programs that provide community-
based care and services to millions of older adults, caregivers, and
people with disabilities each year, became part of the lifeline that
empowered many to stay safely in their homes. Other vital federal
programs provided critical support for caregivers, who became
increasingly isolated during one of our nation's most challenging
periods. Your Subcommittee's work saved lives and helped to ensure
quality care for millions of people. We are grateful to you and your
staff for all you have done.
As we move into the next phase of the pandemic and recovery, we
submit our funding requests for FY 2022 with the sincere hope that
programs supporting family caregivers will again emerge as a priority
for the Subcommittee. The needs of caregivers in your states and across
the nation, including mid-career Americans who are juggling children
and aging parents, have only become more pronounced. Many have left the
workforce altogether because they needed more support. In the wake of
emergency investments that responded to a historic increase in the
needs of older adults and caregivers during the pandemic, federal
investments cannot simply return to normal.
We urge congressional appropriators to embrace, at a minimum, many
of the recommendations included in the FY 2022 Biden Administration
budget. However, for key, national caregiver support programs, we ask
that you consider going above the Administration's request and fund
these programs at levels that sufficiently recognize the immense
challenges that caregivers of all ages and demographics faced during
the global crisis. Therefore, we ask that you consider the following
appropriations requests which fall under the Administration for
Community Living (ACL) and the Administration on Aging (AoA):
--$334,000,000--Older Americans Act Title III E, National Family
Caregiver Support Program (NFSCP), including $400,000 for the
Recognize, Assist, Include, Support, and Engage (RAISE) Family
Caregivers Council
--$21,600,000--Older Americans Act Title VI, Native American
Caregiver Support Services
--$14,200,000--Lifespan Respite Care Program
--$5,000,000--Care Corps Community Care Corps Grants
--$35,000,000 Alzheimer's Disease Program Initiatives (ADPI):
In addition, we ask that you provide $20,000,000 for the BOLD
Infrastructure for Alzheimer's Act initiatives under the Centers for
Disease Control and Prevention. These funding requests align with those
of national coalitions that focus on caregiving, including. the
Leadership Council of Aging Organizations (LCAO), Leaders Engaged in
Alzheimer's Disease (LEAD), and the Eldercare Workforce Alliance (EWA).
I submit these requests and this testimony as the President and
Chief Executive Officer of the National Alliance for Caregiving (NAC).
NAC's mission is to build partnerships in research, advocacy, and
innovation to make life better for family caregivers. Our work aims to
support a society which values, supports, and empowers family
caregivers to thrive at home, work, and life. As a 501(c)(3) charitable
non-profit organization based in Washington, D.C., we represent a
coalition of more than 60 non-profit, corporate, and academic
organizations; nearly 40 family support researchers with expertise in
pediatric to adult care to geriatric care; advocates who work on
national, state, and local platforms to support caregivers across over
30 states. In addition to our national work, NAC leads and works
closely with peer organizations in countries such as Australia, Canada,
Denmark, Finland, France, Hong Kong, India and Nepal, Ireland, Israel,
Japan, New Zealand, Sweden, Taiwan, and the United Kingdom. You can
learn more about NAC and our work at www.caregiving.org.
Background: For the purposes of this testimony, the term
``caregiver'' is defined as it is in the RAISE Family Caregivers Act. A
caregiver is ``an adult family member or other individual who has a
significant relationship with, and who provides a broad range of
assistance to, an individual with a chronic or other health condition,
disability, or functional limitation.'' \1\ Many on this committee have
been personally impacted by family caregiving. We appreciate your
leadership and that of your colleagues in the Senate and House who have
spoken openly, and candidly, about the realities of caregiving.\2\
Those experiences, along with 53 million other Americans who support a
friend or family member, form the backbone of our long-term care
systems.
---------------------------------------------------------------------------
\1\ From P.L. No: 115-119, available at https://www.congress.gov/
bill/115th-congress/house-bill/3759. In research and in advocacy,
``caregiver'' may be described as: informal caregiver, care partner,
caretaker, and related terminology. In an international context, the
term ``carer'' is often used. It should be noted that an estimated 1.4
million children in the U.S. are unpaid caregivers (NAC and United
Hospital Fund, Young Caregivers in the U.S. (2005) at https://
www.caregiving.org/data/youngcaregivers.pdf).
\2\ See Congressional Stories of Family Caregiving (November 2017),
https://www.caregiving.org/wp-content/uploads/2018/02/GSA-
Congressional-Stories-of-Caregiving-briefing-paper.pdf.
---------------------------------------------------------------------------
Family caregiving is a public health issue. In a nationally
representative research study NAC conducted with AARP and released last
year, we identified some of the common issues facing caregivers
today.\3\ Just in the last five years, 9.5 million more people have
taken on caregiving, and we anticipate additional caregivers because of
the coronavirus pandemic. Compared to 2015, family caregivers have
faced more confusing care pathways and face a ``ripple effect'' on
their mental health, physical health, and financial health. About 1 in
5 (18%) of caregivers feel financial strain due to caregiving.
Caregivers often must work less, spend more money out-of-pocket, and
save less for retirement. More people are caring for someone for up to
five years when compared to five years ago--and these caregivers are
more likely to care for someone with multiple care needs. Yet we know
from economic analysis that when supported, family caregivers can
improve health outcomes for individuals, reduce health care costs, and
improve population health.
---------------------------------------------------------------------------
\3\ National Alliance for Caregiving and AARP Public Policy
Institute, Caregiving in the U.S. 2020 (May 2020), Caregiving in the
U.S. 2020--NAC/AARP Research Report
---------------------------------------------------------------------------
Investing in supports and services for caregivers makes sense. Even
modest investments could add an additional $1.7 trillion to the U.S.
GDP by 2030.\4\ New analysis from BlueCross BlueShield \5\ likewise
anticipates that supporting caregivers can improve population health
and reduce costs. Without support, caregivers who were also
commercially insured beneficiaries faced worse overall health, and a
higher prevalence of cost-driving health conditions including anxiety,
major depression, adjustment disorder, behavioral health disorders, and
hypertension. Given the macroeconomic impact of investing in family
caregivers, we respectfully request that this committee prioritize the
following FY 2022 federal investments in this essential population.
---------------------------------------------------------------------------
\4\ AARP. The Economic Impact of Supporting Working Family
Caregivers (2021), available at https://www.aarp.org/content/dam/aarp/
research/surveys_statistics/econ/2021/longevity-economy-working-
caregivers.doi.10.26419-2Fint.00042.006.pdf, https://doi.org/10.26419/
int.00042.006.
\5\ See, BlueCross BlueShield. The Impact of Caregiving on Mental
and Physical Health (9/9/20), last accessed 5/25/21, https://
www.bcbs.com/the-health-of-america/reports/the-impact-of-caregiving-on-
mental-and-physical-health.
---------------------------------------------------------------------------
OAA Title III E-National Family Caregiver Support Program:
We request $334,000,000 for the Older Americans Act's (OAA) Title
III(e), National Family Caregiver Support Program (NFCSP), which is a
critical cornerstone to supporting the dignity and independence of
older adults, adults with disabilities, and the friends or family who
provide care to them. NFCSP offers an entry point for identifying
caregiver needs and can help to address the need for caregiver
education, respite, and support. Since 2000, the program has provided
grants to states and territories to help older adults and people with
disabilities stay in the home as long as possible. The NFCSP offers
five core services including information about available services to
caregivers; assistance to gain access to services; individual
counseling, organizational of support groups, and caregiver education;
respite care, to allow caregivers to take a break; and other important
supplemental services. The NFCSP remains the only nationally
administered program to provide supports and services to caregivers of
older adults and people with disabilities.
Within the National Family Caregiver Support Program, we ask you to
continue--at a minimum--funding the important and groundbreaking work
of the Recognize, Assist, Include, Support, and Engage (RAISE) Family
Caregivers Council. The Administration requested $400,000 for this
ongoing work in their FY 2022 budget request, which would allow the
RAISE Family Caregivers Council to work toward fulfilling its mission
to develop a national strategy to address the needs of family
caregivers of all ages and circumstances.
OAA Title VI C-Native American Caregiver Support Services:
Title VI of the OAA provides grants to eligible Tribal
organizations to promote the delivery of home and community-based
supportive services (HCBS), including nutrition services and support
for family and informal caregivers, to Native American, Alaskan Native,
and Native Hawaiian elders. During the COVID-19 crisis, we witnessed
tragic devastation among tribal elders and their families. Therefore,
we ask you to fund vital caregiver support programs at $21,600,000,
which would fully double the investment in these programs and continue
important support for tribal caregiving communities still recovering
from the ravages of the pandemic.
Lifespan Respite Care Program:
The Lifespan Respite Care Program, administered through the
Administration for Community Living, provides short-term care that
offers individuals or family members temporary relief from the daily
routine and stress of providing care. The program strengthens family
stability and maintains family caregiver health and well-being by
providing often desperately needed respite to exhausted and at-risk
caregivers. Additionally, respite care proved through this program can
save additional federal dollars by helping to delay, or altogether
avoid, out-of-home placements or hospitalizations. Only 14 percent of
family caregivers report having used respite care service, despite
nearly 38 percent feeling respite would be helpful. We urge your
Subcommittee to adopt the President's budget request of $14,200,000 for
this vital program.
Community Care Corps Grants:
Within ACL's program portfolio, we urge you to continue to fund the
important work of the Community Care Corps Grant program at $5,000,000.
The Community Care Corps supports innovative local models in which
trained volunteers assist family caregivers or directly assist older
adults or adults with disabilities in maintaining their independence.
These volunteers provide critical non-medical support and companionship
to supplement their other caregiving options and relieve over-burdened
family caregivers and help meet the growing demand for services from a
large and growing aging and disability population.
Alzheimer's Disease Program Initiatives (ADPI) and BOLD Act
Initiatives:
Within both the Administration for Community Living and the Centers
for Disease Control and Prevention, there are two important programs
that support those caring for Alzheimer's disease and related dementias
(ADRDs). ADPI supports HCBS for people living with ADRD and their
caregivers through grants to states, communities, and Tribal entities.
To support the important work of ADPI, we hope your committee will
support a $35,000,000 FY 2022 funding request. Within CDC, the Building
Our Largest Dementia (BOLD) Infrastructure for Alzheimer's Act
Initiatives establish an effort within the Centers of Excellence in
Public Health Practice dedicated to promoting Alzheimer's disease
management and caregiving interventions. We encourage your Subcommittee
to include $20,000,000 to support the BOLD Initiatives.
In closing, these vital federal efforts and programs that support
millions of family caregivers across the country have a profound impact
on the quality of life. They can reduce caregiver depression, anxiety,
and stress, enabling caregivers to provide care longer and thereby
avoiding or delaying the need for costly hospital and institutional
care. On behalf of myself, the National Alliance for Caregiving, other
national aging and disability advocates, and countless caregivers
across the country, I implore you and your Subcommittee to support FY
2022 funding levels for these programs that recognize and respect the
immense contribution of caregivers to society. Thank you again for all
you have done and will do for older adults and individuals with
disabilities and their caregivers.
[This statement was submitted by C. Grace Whiting, J.D., President
and CEO, National Alliance for Caregiving.]
______
Prepared Statement of the National Alliance for Eye and Vision Research
executive summary
NAEVR, which serves as the ``Friends of the National Eye
Institute,'' is a 501(c)4 non-profit advocacy coalition comprised of 50
organizations involved in eye and vision research, including
ophthalmic/optometric professional societies, patient and consumer
groups, private funding foundations, and industry. NAEVR is immensely
grateful to Congress, especially the House and Senate Appropriations
Subcommittees on Labor, Health and Human Services, and Education
(LHHS), for the strong bipartisan support for National Institutes of
Health (NIH) funding increases from Fiscal Years (FY) 2016 through
FY2021. The $12.85 billion NIH increase in that timeframe has helped
the agency regain ground lost after a decade of effectively flat
budgets.
This past investment in NIH has not only improved our understanding
of fundamental life and health sciences but also prepared the nation to
combat unprecedented health threats, including the COVID-19 pandemic,
and promoted ever-evolving medical advances. To maintain this momentum
in FY2022, NAEVR strongly supports the NIH program funding level of
$51.95 billion as proposed by President Biden, including no less than
$46.1 billion for NIH's base program level budget [absent proposed
funding for the Advanced Research Projects Agency-Health (ARPA-H)], an
increase of at least $3.177 billion or 7.4 percent (as compared to the
Administration's proposed $45.45 billion NIH base funding level, which
is a $2.51 billion or 5.9 percent increase), to enable NIH's base
budget to keep pace with the Biomedical Research and Development Price
Index (BRDPI) and allow for 5 percent growth. This increase is
necessary to support promising science across all Institutes and
Centers (ICs), ensure continued Innovation Account funding established
through the 21st Century Cures Act for special initiatives, and support
early-stage investigators.
NAEVR also urges one-time emergency funding for federal research
agency ``research recovery'' investment to enable NIH to mitigate the
pandemic-related disruptions without foregoing promising new science.
NAEVR supports the bipartisan Research Investment to Spark the Economy
(RISE) Act (H.R. 869/S. 289) which includes $10 billion for NIH
(although at the Subcommittee's May 26, 2021, hearing NIH Director
Francis Collins, MD, PhD estimated that the pandemic shutdown resulted
in a $16 billion loss to its biomedical enterprise). Though pandemic-
related lab closures impacted all researchers, the situation was
especially acute for early-stage investigators. NAEVR's educational
foundation Alliance for Eye and Vision Research (AEVR) documented this
impact in a September 2020 video discussion engaging 22 Emerging Vision
Scientists who described the chilling effect on their research,
collaborations, training, and overall career pathway (a journal article
version of this discussion will be published on July 1, 2021, in JAMA
Ophthalmology),
NAEVR also urges Congress to fund the National Eye Institute (NEI)
at $900 million, a $64.3 million or 7.7 percent increase over FY2021
that reflects both biomedical inflation and growth as compared to the
Administration's $858.4 million funding level, a $22.83 million or 2.7
percent increase. Despite NEI's total $160 million funding increases in
the FY2016-2020 timeframe, its enacted FY2021 budget of $835.7 million
is just 19 percent greater than the pre-sequester FY2021 funding of
$702 million. Averaged over those nine fiscal years, the 2.1 percent
annual growth rate is still less than the average annual biomedical
inflation rate of 2.7 percent, thereby eroding purchasing power. In
fact, NEI's FY2021 purchasing power is less than that in FY2012.
The NEI currently faces an increasing burden of vision impairment
and eye disease due to an aging population, the disproportionate risk/
incidence of eye disease in fast-growing minority populations, and the
impact on vision from numerous chronic diseases (such as diabetes) and
their treatments/therapies. Especially with the COVID-19 pandemic, the
NEI faces additional challenges, as both the working age population and
students have relied almost exclusively on electronic communications
devices and e-learning platforms which can increase the rates of
myopia, dry eye, eye strain, and other vision disorders.
Maintaining the momentum of vision research is vital to vision
health, as well as to overall health and quality of life. Since the US
is the world leader in vision research and training the next generation
of vision scientists, the health of the global vision research
community is also at stake.
nei-funded research saves sight and restores vision
The past federal investment in vision research has led to major
advances in the prevention of vision loss as well as the restoration of
vision.
Audacious Goals Initiative: The NEI has been at the forefront of
regenerative medicine with its Audacious Goals Initiative (AGI), which
launched in 2013 with the goal of restoring vision. Engaging a broad
constituency of scientists from the vision community and numerous other
disciplines, the AGI currently funds major research consortia that are
developing innovative ways to image the visual system. Researchers can
now look at individual nerve cells in the eyes of patients in an
examination room and learn directly whether new treatments are
successful. Another consortium is identifying biological factors that
allow neurons to regenerate in the retina. And the AGI is gathering
considerable momentum with current proposals to develop disease models
that may result in clinical trials for therapies within the next
decade.
Retinal Diseases: The NEI has been at the forefront of research
into retinal diseases. NEI-funded researchers helped show that a
protein called Vascular Endothelial Growth Factor (VEGF) stimulates
abnormal blood vessel growth that occurs in the advanced stages of the
``wet'' form of Age-related Macular Degeneration (AMD) and Diabetic
Retinopathy. Food and Drug Administration (FDA)-approved anti-VEGF drug
therapies that slow the development of blood vessels in the eye delay
vision loss and may improve vision for patients. The NEI has funded
comparison trials of anti-VEGF drugs to provide eye care professionals
and patients with the information they need to choose the best
treatment options.
With respect to the ``dry'' form of AMD, known as geographic
atrophy and the leading cause of vision loss among individuals age 65
and older, in late 2019 NEI began a first-in-human clinical trial that
tests a stem cell-based therapy from induced pluripotent stem cells
(iPSC) to treat geographic atrophy. This trial converts a patient's own
blood cells to iPS cells which are then programmed to become retinal
pigment epithelial (RPE) cells, which nurture the photoreceptors
necessary for vision and which die in geographic atrophy. Bolstering
remaining photoreceptors, the therapy replaces dying RPE with iPSC-
derived RPE.
Genetics/Genomics: The NEI has been at the forefront of genetics/
genomics and gene therapy approaches to various vision disorders--both
common and rare. The causes of AMD and glaucoma remain elusive--
although most cases are not inherited, genetics does play a role. While
NEI-funded researchers have identified many genetic risk factors for
AMD and glaucoma, further study of these genes is helping to elucidate
the biology of these disease and holds promise for improved therapies.
NEI-funded research has also made discoveries of dozens of rare eye
disease genes possible, including the discovery of RPE65, which causes
congenital blindness called Leber congenital amaurosis (LCA). As of
late 2017, NEI's initial efforts led to a commercialized, Food and Drug
Administration (FDA)-approved gene therapy for this condition. These
gene-based discoveries are forming the basis of new therapies that
treat the disease and potentially prevent it entirely.
Front-of-Eye Research: The NEI has launched an Anterior Segment
Initiative (ASI) in order to capitalize on research opportunities at
the front of the eye. The ASI is addressing clinically significant,
quality-of-life problems such as ocular pain and Dry Eye Disease (DED),
especially in terms of pain and discomfort sensations, as well as
disruptions in the tearing process. Using multi-disciplinary
approaches, the ASI plans to elucidate relevant anterior segment
innervation pathways that contribute to normal or abnormal functioning
of the neural circuits related to the ocular surface.
congress must robustly fund the nei as it addresses the increasing
burden of vision impairment and eye disease
NEI's FY2021 enacted budget of $835.7 million is less than 0.5
percent of the $177 billion annual cost (inclusive of direct and
indirect costs) of vision impairment and eye disease, which was
projected in a 2014 Prevent Blindness study to grow to $317 billion--or
$717 billion in inflation-adjusted dollars--by year 2050. Of the $717
billion annual cost of vision impairment by year 2050, 41 percent will
be borne by the federal government as the Baby-Boom generation ages
into the Medicare program. A 2013 Prevent Blindness study reported that
direct medical costs associated with vision disorders are the fifth
highest--only less than heart disease, cancers, emotional disorders,
and pulmonary conditions. The U.S. is spending only $2.53 per-person,
per-year for vision research, while the cost of treating low vision and
blindness is at least $6,680 per-person, per-year. [http://
costofvision.preventblindness.org/]
A May 2021 JAMA Ophthalmology article reported that more than 7
million people in the U.S. are living with uncorrectable vision loss,
including more than 1 million with blindness. Of those living with
vision loss and blindness, nearly 1 in 4 are under the age of 40, while
20 percent of all people aged 85 and older experience permanent vision
loss. More females than males experience permanent vision loss or
blindness, and the Hispanic and African American populations experience
a higher risk of vision loss. This study's research methods allowed for
a broader analysis of populations in the U.S. (including individuals
under age 40) than that used in previous national estimates of vision
loss and blindness. [doi:10.1001/jamaophthalmol.2021.0527]
In an August 2016 JAMA Ophthalmology article, AEVR reported from a
national attitudinal survey that a majority of Americans across all
racial and ethnic lines describe losing vision as having the greatest
impact on their day-to-day life. Other studies have reported that
patients with diabetes who are experiencing vision loss or going blind
would be willing to trade years of remaining life to regain perfect
vision, since they are concerned about their quality of life.
[doi:10.1001/jamaophthalmol.2016.2627]
Investing in vision health is an investment in overall health.
NEI's breakthrough research is a cost-effective investment, since it
leads to treatments and therapies that may delay, save, and prevent
health expenditures. It can also increase productivity, help
individuals to maintain their independence, and generally improve the
quality of life--as vision loss is associated with increased
depression/accelerated mortality.
In summary, NAEVR supports the President's request for $51.95
billion in NIH funding but urges the Subcommittee to appropriate no
less than $46.1 billion for NIH's base program level and $900 million
for the NEI. NAEVR also supports one-time emergency ``research
recovery'' investment to mitigate the pandemic-related disruptions
without foregoing promising new science.
NAEVR thanks the Subcommittee for the opportunity to submit this
written testimony, especially as it continues to grapple with the long-
term challenges from the COVID-19 pandemic.
For more information, visit NAEVR's Web site at
www.eyeresearch.org.
[This statement was submitted by James Jorkasky, Executive
Director, National Alliance for Eye and Vision Research.]
______
Prepared Statement of the National Alliance for Public Charter Schools
Madam Chair and Members of the Subcommittee, I am pleased to
present the views of the National Alliance for Public Charter Schools
on the fiscal year (FY) 2022 appropriation for the Charter Schools
Program (CSP), which is administered by the U.S. Department of
Education. I thank the Subcommittee for maintaining strong support for
the CSP, including by providing $440 million for FY 2021. The CSP plays
a critical role in expanding educational opportunities for families and
in improving educational outcomes nationwide. As the Subcommittee
considers the FY 2022 Labor, Health and Human Services, Education and
Related Agencies appropriation, we request an increase in funding for
the CSP to at least $500 million.
We support the Administration's proposed investments in programs
that will benefit all public school students, including the Title I
program and the Individuals with Disabilities Education Act. These
increases, along with the other COVID relief funds, will help charter
schools, like other public schools, address the many challenges they
face after the pandemic-related shutdowns. At the same time, we were
disappointed to see that the Administration's budget proposal called
for flat funding of the CSP. The CSP is the only source of federal
funding to support the growth of high-quality charter schools in the
communities that need them most. Given charter schools' history of
educating students with disadvantages in diverse situations, a $60
million increase for the CSP will deliver outsized returns.
the operation of charter schools during the pandemic
The COVID-19 pandemic has been extremely challenging for charter
schools, just as for all other public schools. Most had to pivot
quickly from on-site instruction to distance learning, ensure that
teachers had the skills and knowledge to deliver online instruction
effectively, overcome disparities in student access to technology, and
address many other challenges. Fortunately, charter schools are used to
innovating and adapting to meet changing needs, and in this time of
crisis they were able to leverage their autonomy effectively. A recent
report released in partnership with Public Impact found that small
charter networks and single-site charter schools (which together
account for 65 percent of all charter schools) were more likely than
district schools to set expectations that teachers would engage in
real-time synchronous instruction, check in regularly with students,
and monitor attendance. Parents have responded accordingly: an April
2021 survey of more than 2,700 parents nationwide found that 65 percent
believe that choices like charter schools and learning pods would be
``extremely or very effective'' in helping students in their state.
Parents want more opportunities for their kids, and charter schools are
one critical way of providing them.
understanding charter schools and their accomplishments
In recent years, and notwithstanding charter schools' achievements
and significant efforts to meet the needs of students during the
pandemic, we have seen a number of misconceptions emerge about charter
schools. To be clear, charter schools are public schools, supported by
taxpayers, and open to all students, without entrance requirements. The
CSP is the only federal K-12 program that requires its recipients to be
open enrollment. Each State decides who may authorize charter schools
and how schools will be held accountable for meeting the goals laid out
in their charters. And charter schools, as public schools of choice,
are ultimately accountable to parents: if a charter school is not
delivering for families, it will not remain open. Moreover, while
charter schools typically have more flexibility than district schools--
such as to set curriculum, hire teachers and staff, and adapt to meet
the needs of their students--they are required to meet the same
academic testing and Title I accountability requirements as other
public schools.
Most importantly, although there is some variety in charter school
performance, in the main they are delivering. The 2015 Urban Charter
School Study, from the Center for Research on Education Outcomes
(CREDO) at Stanford University, found that students in urban charter
schools gained an average of 40 additional days of learning per year in
math and 18 days in reading, compared to their non-charter-school
peers. Moreover, the study found that the longer a student attends an
urban charter school, the greater the gains: four or more years of
enrollment in such a school led to 108 additional learning days in math
and 72 in reading.
More recently, a 2020 study from the Program on Education Policy
and Governance at Harvard University found greater academic gains for
students in charter schools than for students in traditional public
schools who took the reading and math assessments administered by the
National Assessment of Educational Progress (NAEP) in fourth and eighth
grade between 2005 and 2017. African American and low-income students
attending charter schools were almost 6 months ahead of their peers in
reading and math compared with students in traditional public schools
over the 12-year span of the study. This was the first nationwide study
to compare student achievement trends over time between sectors rather
than effectiveness at a single point in time.
the importance of the federal charter schools program
First authorized in 1994 through the bipartisan efforts of
President Bill Clinton and Congressional leaders, the CSP was
originally created to support the start-up costs of new schools. Since
then, the program has enjoyed strong support from Presidents and
Members of Congress from both parties, and has expanded to address the
changing needs of the movement.
Since its inception, Congress has appropriated some $6.3 billion
for the CSP. To put that number in context, it amounts to less than 2
percent of the appropriation for ESEA Title I LEA Grants over that same
time period. This modest investment has helped the number of charter
schools grow from only a handful in the early 1990s to around 7,500
schools and campuses today that serve around 3.3 million public school
students. CSP has made many of those schools possible by supporting
non-sustained start-up costs not covered by per-pupil funding-such as
planning, staff training, equipment and materials, renovations,
recruitment, and other necessary start-up activities. In addition,
State appropriations have often not given charter schools the same
level of per-pupil support as non-charter schools, and often have not
addressed their facilities needs. The majority of all charter schools,
therefore, have needed CSP grants to open.
The CSP makes it possible for new charter schools to open to
address changing community needs. One such school--Lumen High School in
Spokane, WA--received a 2020 subgrant from the Washington State Charter
Schools Association, a 2019 State Entity CSP grant recipient. Lumen is
a dual-generational school designed to meet the layered need of teen
parents. It offers childcare and early childhood education,
incorporates parenting skills in the curriculum, and offers critical
wraparound services to eliminate barriers that might keep parenting
teens from accessing education. When the COVID-19 pandemic struck,
Lumen's founding Executive Director was offered the chance to delay
opening for a year but chose to put the needs of her community first
and open in the midst of the pandemic because, as she explained, ``our
students need school now.'' Increased CSP funding makes it possible for
schools like Lumen to open in the communities that need them most.
Charter school enrollment has grown rapidly, but it has not kept up
with family demand. Surveys indicate that some 3.3 to 3.5 million
additional students would attend a charter school if space were
available to them. Many of those are students who currently attend
schools identified as in need of support and improvement under Title I,
that is, schools that are not meeting State performance targets. The
increase we recommend would enable the creation of charter schools to
serve more of the students and families who want them.
fiscal year 2022 request
As previously noted, our request for FY 2022 is $500 million-a $60
million increase that would be a wise investment. Within the account,
funds should be allocated to programs with floors and ceilings so that
the Department can shift funds according to the needs of the field from
one year to the next. $500 million would provide sufficient funding for
new grants to States and CMOs and thus enable those entities to support
the creation of new charter schools. This would reduce wait lists and
provide high-quality educational options to more families, particularly
those in communities that have been hit hard by the pandemic and where
the learning needs are greatest. It will also help ensure funds are
available for states that have recently strengthened their charter
school laws, including Iowa, Wyoming, and West Virginia.
Finally, our request would help charter schools access appropriate
facilities. Charter schools generally have not had the same access to
funding sources that support the facilities needs of other public
schools, such as municipal bonds, property tax revenues, and State
school facilities programs. This forces schools to scrape by in
buildings not designed for learning, use funds that should have been
available for instruction to cover facility needs, or simply not open
at all. The two small facilities programs included in the CSP--Credit
Enhancement for Charter School Facilities and the State Facilities
Incentive Grants--help fill some of this unmet need.
conclusion
The National Alliance for Public Charter Schools takes great pride
in the growth and accomplishments of public charter schools over the
last quarter century. Our schools' enrollments continue to climb, and
more and more studies have found that charter schools are succeeding:
they increase achievement and meet the other needs of a diverse and
often historically underserved student population. This success could
not have been achieved without the CSP. We ask that you continue that
support and accept our recommendation for $500 million for FY 2022.
[This statement was submitted by Nina Rees, President and CEO,
National
Alliance for Public Charter Schools.]
______
Prepared Statement of the National Alliance on Mental Illness
Chairwoman Murray, Ranking Member Blunt and Members of the
Subcommittee, on behalf of the National Alliance on Mental Illness,
thank you for the federal investments in mental health crisis response
that you have supported and made possible so far. I appreciate the
opportunity to discuss NAMI's priorities, many of which we share, as
evidenced by the hearing this Subcommittee held last week on building a
robust crisis response system. Without personnel who are trained to
handle mental health emergencies, and without the infrastructure in
place, the default response to many people in crisis is a law
enforcement response, which often ends in trauma or tragedy. In fact,
one in four fatal police shootings are of people with mental illness,
with one in three being people of color. The lack of effective crisis
response also burdens emergency departments (EDs) that are ill-equipped
for mental health crises, despite the fact that one of every eight ED
visits is related to a mental health or substance use disorder. But as
you said in your statement, Madame Chairwoman, there is something we
can do about it. Thank you for your leadership.
NAMI is grateful that Congress passed the bipartisan National
Suicide Hotline Designation Act of 2020, which created 988 as a three-
digit mental health and suicide crisis line that will go live
nationwide by July 16, 2022. This alternative to 911 gives communities
the opportunity to transform care by developing 988 crisis response
systems with the core elements described in SAMHSA's National
Guidelines for Crisis Care: 1) crisis call centers, 2) mobile crisis
teams, and 3) crisis receiving and stabilization programs. Crisis call
center hubs, staffed by people well-trained in crisis response, can
assist the vast majority of people calling with a behavioral health
crisis. For those who need more, mobile crisis teams provide an in-
person response and are able to effectively de-escalate the majority of
behavioral health crises and connect people to follow-up services. In
situations where needs are more acute, crisis receiving and
stabilization services provide safe, therapeutic settings that reduce
reliance on ED visits and can avoid the need for hospitalization.
While there is a clear vision for successful 988 crisis response
systems, few systems meet the standards needed to realize this vision.
Currently, National Suicide Prevention Lifeline (Lifeline) call centers
rely on a patchwork of inadequate funding, leaving insufficient
capacity to meet current needs, let alone the increased demand that
will be spurred by the adoption of 988. There is growing availability
of mobile crisis teams, but demand still far outstrips supply,
particularly for children and adolescents. There is a dearth of crisis
stabilization programs nationwide, and widespread shortages of
behavioral health professionals to staff crisis response systems.
Robust federal investment is required to realize the promise of 988
to deliver a mental health response to mental health crises. Some
states are adopting 988 user fees, but those fees are minimal and will
support only a portion of 988 crisis system costs. Medicaid rarely
covers the full costs of the core services--and it does not cover
services for people who are not Medicaid-eligible. Without federal
support, communities will be unable to develop and sustain a crisis
infrastructure that ensures a mental health response will be available
for mental health crises.
To help communities develop capacity for the critical first element
of a 988 crisis system, crisis call center response, NAMI strongly
recommends including $240 million in FY2022 for the National Suicide
Prevention Lifeline. This recommendation is based on an initial
analysis from Vibrant Emotional Health, the current administrator of
the Lifeline. This will provide needed funding to expand capacity for
988 calls, chats, and texts, including implementing technology,
enhancing standards and training, and providing nationwide back-up for
local call centers.
In FY2021, this Subcommittee included an additional $35 million in
the Mental Health Block Grant to fund a 5% set-aside for Crisis Care
Services. While this was a valuable start and we are grateful for this
investment that is helping states develop crisis services, especially
mobile crisis teams, the need is substantial. That is why NAMI is
requesting a 10% set-aside for crisis services in FY2022 to provide
critical funds to both start up crisis services and to support the many
costs of crisis care that are not covered by Medicaid or insurance
plans.
NAMI is also requesting $12.5 million for the SAMHSA Strengthening
Community Crisis Response Systems program. When someone experiences a
mental health crisis, they often wind up in hospital emergency
departments (EDs) where they frequently end up waiting in hallways,
sometimes for days, before being admitted to an inpatient or
residential facility. This practice, referred to as ``ED boarding,'' is
harmful to patients and strains already-burdened EDs. The $12.5 million
we are requesting will help communities reduce the traumatic practice
of ED boarding by providing intensive crisis services, such as crisis
receiving and stabilization programs, and by implementing databases of
beds at inpatient and residential behavioral health facilities that
help reduce the wait for intensive treatment.
These three programs, while important, are only part of realizing
the promise of a successful crisis response system. And while some of
the needed investments fall outside this Subcommittee's jurisdiction, I
believe it is important to give you the full picture of what is
required to effectively implement a comprehensive 988 crisis response
system over the next several years.
Whether through the annual appropriations process, broader efforts
to upgrade our country's infrastructure, or other means, Congress must
invest $10 billion over the next 10 years in 988 infrastructure in
three key areas: 1) Supporting capital projects and operations, 2)
Increasing the behavioral health workforce, and 3) Ensuring Medicare,
Medicaid, and TRICARE coverage. I would like to give you a quick
overview of what is needed in each area.
First, supporting 988 capital projects and operations. To build a
mental health crisis system that relies on well-equipped 988 call
centers as the first point of contact, federal support of the national
Lifeline should be supplemented by federal authorization and funding,
based on SAMHSA's projections, to support operations at 180+ local
Lifeline call centers across the country. This will ensure that people
get connected to services when and where they need them.
In addition, communities need support for capital expenses to
expand crisis services, such as mobile crisis team vans, facilities for
crisis receiving and stabilization and peer respite programs, and call
center infrastructure. Congress should expand funding and broaden the
uses of the Health Resources and Services Administration's (HRSA)
current Capital Development Grants to include crisis system
infrastructure.
Second, increasing the behavioral health workforce. As the
Subcommittee knows, behavioral health workforce shortages pose
challenges for health systems, including crisis response. Congress can
help by significantly expanding behavioral health workforce training
programs, including HRSA's Behavioral Health Workforce Education and
Training (BHWET) and Graduate Psychology Education (GPE) programs, as
well as SAMHSA's Minority Fellowship Program (MFP). In addition, to
help recruit and retain skilled staff, HRSA's National Health Service
Corps Loan Repayment Program criteria must be expanded to include
crisis call centers, mobile crisis teams, crisis receiving and
stabilization programs, and Certified Community Behavioral Health
Clinics.
Third, ensuring Medicare, Medicaid, and TRICARE coverage of crisis
services. It is also vital that Medicare, Medicaid, and TRICARE cover
mobile crisis and crisis stabilization services. Together, these
programs cover tens of millions of people, many of whom will experience
mental health and suicidal crises and deserve an appropriate response.
Peer support specialists in particular play critical roles in crisis
services yet are not covered providers under Medicare. That must
change. Finally, to maximize access to behavioral health crisis
services, Congress should make permanent the current flexibilities for
Medicare coverage of telehealth behavioral health services.
It is NAMI's priority to ensure that an effective 988 crisis
response system infrastructure is developed across the country and we
are grateful for this Subcommittee's support. We recognize that it is
also important to invest in research and a wide range of prevention,
intervention, and recovery programs at SAMHSA, including Certified
Community Behavioral Health Clinics, that help people get on a path of
recovery. To that end, we urge your consideration of the Mental Health
Liaison Group (MHLG) recommendations for FY2022 appropriations. NAMI
also offers our strong support for the President's FY2022 proposed
budget of $1.6 billion for the community mental health block grant and
$1 billion to increase mental health professionals in schools.
Thank you for this opportunity and for the leadership you have
demonstrated in advancing mental health care. I look forward to working
with you to put in place the infrastructure to support a 988 crisis
response system and transforming mental health care in America.
[This statement was submitted by Angela Kimball, National Director
of Advocacy & Public Policy, National Alliance on Mental Illness.]
______
Prepared Statement of the National Alliance to End Sexual Violence
The National Alliance to End Sexual Violence (NAESV) is the voice
in Washington for the 56 state and territorial sexual assault
coalitions and 1500 local programs working to end sexual violence and
support survivors. The programs included in the Violence Against Women
Act (VAWA) are a vital part of local programs' work to support
survivors and end sexual violence. This testimony focuses specifically
on the Rape Prevention & Education Program (RPE), a VAWA program
located at the Centers for Disease Control, Injury Center, and the need
to increase funding for the program from $51.75 million to $100 million
in FY 22 as recommended by the President's budget and include report
language requiring the collaboration with state sexual assault
coalitions in the program. We are grateful to the committee for the $1
million increase for RPE in FY 21, however, increased funding is
desperately needed.
RPE formula grants, administered by the CDC Injury Center, provide
essential funding to states and territories to support rape prevention
and education programs conducted by rape crisis centers, state sexual
assault coalitions, and other public and private nonprofit entities. In
the past few years, demand for programs funded by RPE have skyrocketed,
the evidence base has progressed significantly, the current
appropriation is very nearly the authorized level, and further
investment in the program is desperately needed. The #MeToo movement,
the national focus on campus sexual assault, and high-profile cases of
sexual violence in the media have increased the need for comprehensive
community responses to sexual violence but have also increased the
demand for prevention programs beyond providers' capacity.
According to the National Intimate Partner and Sexual Violence
Survey (CDC, 2015 national data):
--21% of women and 3% of men reported completed or attempted rape
ever in their lifetime.
--Among victims of rape, 43% (11 million) of females and 51% (1.5
million) of males reported it occurred for the first time
between the ages of 11-17.
If our children are to face a future free from sexual violence, RPE
must be increased. The RPE program prepares everyday people to become
heroes, getting involved in the fight against sexual violence and
creating safer communities by engaging boys and men as partners;
supporting multidisciplinary research collaborations; fostering cross-
cultural approaches to prevention; and promoting healthy, non-violent
social norms, attitudes, beliefs, policies, and practices.
We know RPE is working.
A 2016 study conducted in 26 Kentucky high schools over 5 years and
published in American Journal of Preventive Medicine found that an RPE-
funded bystander intervention program decreased not only sexual
violence perpetration but also other forms of interpersonal violence
and victimization.
``The idea that, due to the effectiveness of Green Dot, ... there
will be many fewer young people suffering the pain and devastation of
sexual violence: This is priceless.'' Eileen Recktenwald, Kentucky
Association of Sexual Assault Programs
Across the country, states and communities are engaged in cutting-
edge prevention projects:
--Connecticut's Women & Families Center developed a multi-session
curriculum addressing issues of violence and injury targeting
middle school youth.
--Oklahoma is working with domestic violence and sexual violence
service agencies, public and private schools, colleges and
other community-based organizations to prevent sexual violence.
--Alaska's Talk Now Talk Often campaign is a statewide effort
developed in collaboration with Alaskan parents, using
conversation cards, to help increase conversations with teens
about the importance of having healthy relationships.
--Kansas is looking closely at the links between sexual violence and
chronic disease to prevent both.
--Maryland's Gate Keepers for Kids program provides training to
youth-serving organizations to safeguard against child sexual
abuse.
--Missouri is implementing ``Green Dot'' bystander education
statewide to reduce the rates of sexual violence victimization
and perpetration.
--North Carolina was able to ensure sustainability of its consent-
based curriculum by partnering with the public-school system to
implement their sexual violence prevention curriculum in every
8th grade class.
--Washington is implementing innovative skill building projects that
amplify the voices of historically marginalized communities,
such as LGBTQ youth, teens with developmental disabilities,
Asian American & Pacific Islander teens, & Latino parents &
children.
Why increase funding for RPE?
The societal costs of sexual violence are incredibly high including
medical & mental health care, law enforcement response, & lost
productivity. 2017 research sets the lifetime economic burden of rape
at $122 million per victim and also reveals a strong link between
sexual violence and chronic disease.
The national focus on campus and military sexual assault as well as
high profile cases of sexual violence in the media have increased the
need for comprehensive community responses to sexual violence but has
also increased the demand for prevention programs beyond providers'
capacity.
A Missouri program reported: ``The demand for our services has
increased about 18% both in 2014 and in 2015. Increased awareness and
increased need (crime) are most likely contributors to this trend.
There are limited resources available for prevention education. In
addition, new government requirements/laws, such as with Title IX and
PREA, have contributed to referrals to our organization. Our
organization always works to increase support from local resources, but
funding is extremely competitive and limited.''
A Massachusetts program reported: ``With Title IX in the news,
requests for prevention education have increased...We are saying no to
many requests for education because of capacity issues. We are unable
to build and sustain relationships with other underserved communities
because of a lack of capacity.''
A Nebraska program reported: ``I am hugely dismayed at the lack of
funding for prevention...It's noble to provide direct services to
victims of sexual violence, but if we don't provide prevention monies,
then we are just a band-aid. It's terribly frustrating.''
Funded involvement of state sexual assault coalitions is imperative for
the success of RPE.
RPE was first authorized in the original 1994 version of the
Violence Against Women Act (VAWA) and has been reauthorized
subsequently with each iteration of VAWA. RPE was the brainchild of
National Alliance to End Sexual Violence (NAESV) founder, Gail Burns-
Smith, as a coordinated federal response to the prevention of sexual
violence. While funding goes to state health departments, the original
intent of the RPE program was to fully involve state sexual assault
coalitions and rape crisis centers as leaders in this work because of
their vast experience in addressing sexual violence. Over the years,
the level of involvement of state coalitions has varied between states
and has ebbed and flowed. At the same time, there are states in which
the state sexual assault coalition has never been meaningfully involved
in RPE.
During 2019, NAESV met with state sexual assault coalitions and
conducted two membership surveys. While some state coalitions continue
to have good and strong working relationships with their state health
departments and feel positively about how RPE is being administered,
based on our research, over half of the state sexual assault coalitions
are dissatisfied or very dissatisfied with how RPE is being
administered. This past year, there have been changes in some states
that have resulted in both concerns about state approaches to RPE and
elimination of some state sexual assault coalitions involvement in RPE-
funded prevention work. Our research also found that:
1. One in four coalitions expressed a concern about lack of sexual
violence expertise in the administration of RPE at the state level.
2. 30% of coalitions have concerns about lack of collaboration and
leadership.
3. Over 60% of coalitions thought there was too little involvement
of community based sexual assault programs in the work of RPE.
NAESV has concluded, with the complete consensus of state sexual
assault coalitions, that enough states are having a problem to warrant
a legislative solution. Communities deserve the best, most well-
informed prevention efforts especially in this era where demand and
interest in sexual violence prevention is so high. We know, with the
funded involvement of state sexual assault coalitions and increased
funding, RPE can be an even more powerful tool in ending sexual
violence. The field looked to other successful national formula grants
designed to address violence against women as a guide in developing a
legislative proposal. The STOP and Sexual Assault Services (SASP)
Programs at the Department of Justice Office on Violence Against Women
(OVW), designed to provide a criminal justice and survivor services
response respectively, both include language to require meaningful
collaboration as well as funding to state sexual assault coalitions. We
suggest following the success of these grant programs to also ensure
the meaningful, funded involvement of state sexual assault coalitions
in the prevention of sexual violence.
We recommend the following report language:
``The Committee believes significant involvement of state sexual
assault coalitions and underserved communities is critical to
ensure rape prevention education dollars are spent on the most
impactful programs. So in granting funds to states, the
Director of the National Center for Injury Prevention and
Control shall set forth procedures designed to ensure
meaningful involvement of the State or territorial sexual
assault coalitions and representatives from underserved
communities in the application for and implementation of
funding.''
Funding History: In the 2013 reauthorization of Violence Against
Women Act, Congress cut authorization for RPE from $80 to $50 million.
In FY 17, the program was funded at $44.4 million, a $5 million
increase from FY 16. In FY 18 & FY 10, RPE was funded in the omnibus at
$49.4 million. In FY 20, RPE was funded at $50.75 million. In FY 21,
RPE was funded at $51.75 million.
Please increase funding for RPE to $100 million and include report
language requiring the funded collaboration of state sexual assault
coalitions in the RPE program.
Please feel free to contact me with any additional questions at
[email protected].
[This statement was submitted by Terri Poore, Policy Director,
National Alliance to End Sexual Violence.]
______
Prepared Statement of the National Alopecia Areata Foundation
the foundation's fiscal year 2022 l-hhs appropriations recommendations
_______________________________________________________________________
--At least $46.1 billion for the National Institutes of Health (NIH).
--Proportional funding increases for National Institute of
Arthritis and Musculoskeletal and Skin Diseases (NIAMS),
National Institute of Allergy and Infectious Diseases
(NIAID) and the National Center for Advancing Translational
Science (NCATS)
--Please provide $10 billion for the Centers for Disease Control and
Prevention (CDC).
--Please provide $5 million for the Chronic Disease Education and
Awareness Program.
_______________________________________________________________________
Chairwoman Murray, Ranking Member Blunt and distinguished members
of the Subcommittee, thank you for your time and your consideration of
the priorities of the alopecia areata community as you work to craft
the FY2022 L-HHS Appropriations Bill.
about alopecia areata
Alopecia areata is a prevalent autoimmune skin disease resulting in
the loss of hair on the scalp and elsewhere on the body. It usually
starts with one or more small, round, smooth patches on the scalp and
can progress to total scalp hair loss (alopecia totalis) or complete
body hair loss (alopecia universalis).
Alopecia areata affects approximately 2.1 percent of the
population, including more than 6.9 million people in the United States
alone. The disease disproportionately strikes children and onset often
occurs at an early age. This common skin disease is highly
unpredictable and cyclical. Hair can grow back in or fall out again at
any time, and the disease course is different for each person. In
recent years, scientific advancements have been made, but there remains
no cure or indicated treatment options.
The true impact of alopecia areata is more easily understood
anecdotally than empirically. Affected individuals often experience
significant psychological and social challenges in addition to the
biological impact of the disease. Depression, anxiety, and suicidal
ideation are health issues that can accompany alopecia areata. The
knowledge that medical interventions are extremely limited and of minor
effectiveness in this area further exacerbates the emotional stresses
patients typically experience.
about the foundation
NAAF, headquartered in San Rafael, California, supports research to
find a cure or acceptable treatment for alopecia areata, supports those
with the disease, and educates the public about alopecia areata. NAAF
is governed by a volunteer Board of Directors and a prestigious
Scientific Advisory Council. Founded in 1981, NAAF is widely regarded
as the largest, most influential, and most representative foundation
associated with alopecia areata. NAAF is connected to patients through
local support groups and also holds an important, well-attended annual
conference that reaches many children and families.
NAAF initiated the Alopecia Areata Treatment Development Program
(TDP) dedicated to advancing research and identifying innovative
treatment options. TDP builds on advances in immunological and genetic
research and is making use of the Alopecia Areata Clinical Trials
Registry which was established in 2000 with funding support from the
National Institute of Arthritis and Musculoskeletal and Skin Diseases;
NAAF took over financial and administrative responsibility for the
Registry in 2012 and continues to add patients to it. NAAF is engaging
scientists in active review of both basic and applied science in a
variety of ways, including the November 2012 Alopecia Areata Research
Summit featuring presentations from the Food and Drug Administration
(FDA) and NIAMS.
NAAF is also supporting legislation to provide coverage for cranial
prosthetics under Medicare. This bill will grant increased access to
cranial prosthetics and therapies for patients with alopecia areata and
other forms of medical hair loss. Many patients living with medical
hair loss suffer from a variety of diseases, including cancer. With no
known cause or cure, alopecia areata is an autoimmune skin disease
affecting approximately 6.9 million Americans, many of whom are
children.
national institutes of health
NIH hosts a modest alopecia areata research portfolio, and the
Foundation works closely with NIH to advance critical activities. NIH
projects, in coordination with the Foundation, have the potential to
identify biomarkers and develop therapeutic targets. In fact,
researchers at Columbia University Medical Center (CUMC) have
identified the immune cells responsible for destroying hair follicles
in people with alopecia areata and have tested an FDA-approved drug
that eliminated these immune cells and restored hair growth in a small
number of patients. This huge breakthrough has led to NIAMS providing a
research grant to the researchers at Columbia to continue this work. In
this regard, please provide NIH with meaningful funding increases to
facilitate growth in the alopecia areata research portfolio.
patient perspective
``There is a chance you could lose all your hair.'' That was the
last thing anyone ever wants to hear. I will never forget standing in
the shower in November 2015 with my hands full of hair and in complete
disbelief. Was this really happening to me? I felt as though my
identity was being ripped away from me as every strand of hair fell out
of my head. My hair was my identity. Who would I be without it? How was
I going to live like this for the rest of my life?
I lost all of my hair on my entire body including eyebrows and
eyelashes within four weeks and I was diagnosed with the autoimmune
disease called alopecia areata. For the next year, I did everything in
my power to grow my hair back from every topical cream to medicines
that compromised my immune system to weekly steroid injections into my
scalp. This was the worst pain I had ever experienced in my life but I
would do anything to grow my hair back.
Nothing was working. I had to stop as my mind, body, and soul
couldn't take it anymore.
I don't know what was worse, the treatments or the stares I would
receive out in public as everyone thought I was going through treatment
for cancer. I wanted to blend in with society so badly, but wigs were
so expensive. I refused to look at myself in the mirror because I hated
the reflection. I wore a hat everywhere I went even to bed until the
lights were turned off to take it off and I wouldn't take any pictures,
especially during the holidays because I was ashamed of my appearance.
I wanted my life back so I could be a good mom to my daughters and just
enjoy life. Alopecia areata is not just cosmetic, it takes an emotional
toll as it caused severe anxiety and depression that I continue to deal
with years later. I was very fortunate to have the unconditional
support of my parents who helped me to purchase wigs so I could feel
somewhat normal again; however, there are too many people with alopecia
areata who do not have the luxury of support that I was blessed with.
Your support would impact people's lives immensely.
Thank you for the opportunity to testify before you today. NAAF
looks forward to working with you all to advance medical research and
public health activities that will improve patient outcomes for the
members of our community suffering from alopecia.
[This statement was submitted by Jeanne Rappoport, Acting Chief
Executive
Officer, National Alopecia Areata.] Foundation.]
______
Prepared Statement of the National Association for
State Community Services Programs
As Board President of the National Association for State Community
Services Programs (NASCSP), I am pleased to submit testimony in support
of the Department of Health and Human Services' (HHS) Community
Services Block Grant (CSBG). We are seeking a Fiscal Year 2022
appropriation level of $800 million for CSBG and an increase in client
eligibility to 200% of the Federal Poverty Level. The current 200%
eligibility established under the Coronavirus Aid, Relief, and Economic
Security (CARES) Act will expire at the end of Fiscal Year 2021,
creating a steep drop-off of services for many vulnerable families
during a critical time of recovery. These funding and eligibility
levels will empower States and local communities with the resources
they need to lead the fight against poverty through innovative,
effective, and locally tailored anti-poverty programs that help
individuals, families, and communities achieve economic security.
NASCSP is the member organization representing the State CSBG
Directors in all 50 states, the District of Columbia, and three U.S.
territories on issues related to CSBG and economic opportunity. NASCSP
provides training and technical assistance to empower State Offices in
implementing program management best practices and in developing
evidence-based policy. The State Offices represented by our
organization would like to thank the members of this committee for
their support of CSBG over the years, particularly for the supplemental
funding through the CARES Act and the increase to CSBG in the FY 2021
Labor-HHS Bill.
CSBG is a model example of a successful Federal-State-Local
partnership, a fact I can personally attest to having worked for more
than 15 years in the Arkansas State CSBG office. I worked closely with
the local Community Action Agencies and with federal OCS and ACF staff.
The CSBG network leverages federal and non-federal funds to support a
range of essential services and activities that improve the lives and
communities of Americans. These activities are incredibly important to
vulnerable individuals and families, especially during times of crisis.
CSBG is in every state and county, from the most urban counties to the
most rural ones, where CSBG furthers the critical goals of economic
security, social mobility, and racial justice. I will highlight three
main points in my testimony:
1. The structure of CSBG empowers States and local communities to
take the lead on poverty, giving States wide discretion to tailor
funding to their unique economic and social conditions.
2. CSBG creates impact in communities across the country by
leveraging additional private, local, state, and federal investments to
fight poverty, serving as the national human services infrastructure by
weaving together and coordinating private and public antipoverty
efforts.
3. The robust local, state, and federal accountability measures of
the CSBG Performance Management Framework are uniquely comprehensive
when compared to other federal programs, preventing service duplication
and fostering continuous improvement.
Structure
Proponents of state and local anti-poverty efforts often highlight
their ability to tailor services, asserting that state and local
leaders are best equipped to tackle the challenges facing their
communities. CSBG is a block grant administered and managed by states,
who administer and distribute funds to a nationwide network of more
than 1,000 local CSBG Eligible Entities, also known as Community Action
Agencies or CAAs. The CSBG network forms the bedrock of the human
services infrastructure that uplifts urban, rural, and suburban
communities across the United States. In some rural counties, the CAA
is the only human services organization addressing poverty and
uplifting low-income families in the community.
State offices distribute funds to Community Action Agencies, who
utilize CSBG funds to address their specific local needs, often in one
or more of these core domains: employment, education and cognitive
development, income, infrastructure and asset building, housing, health
and social behavioral development, and civic engagement and community
involvement. The CSBG Act requires that these services are shaped by a
community needs assessment performed at least every three years,
ensuring programs are tailored and responsive to unique community
needs, rather than a one-size-fits-all solution. The needs assessment
prevents service duplication and incorporates community feedback in the
strategic planning process.
Furthermore, the CSBG Act requires at least one-third of a
Community Action Agency's board to be composed of people with low-
incomes or their representatives, ensuring that local needs and
viewpoints are accurately reflected in organizational priorities. In
addition to low-income representation, Community Action boards are also
comprised of local elected officials or their representatives and
community stakeholders including local businesses, other assistance
organizations, professional groups, and community organizations. This
unique tripartite structure assures the needs of a community are
identified and met with the available resources necessary to maximize
outcomes and impact. The tripartite structure of Community Action
boards calls on all sectors of society to join in the shared fight
against poverty.
State Offices are charged with providing the oversight and support
necessary for effective administration of CSBG at the local and state
levels. States provide training and technical assistance to build the
capacity of local CAAs; ensure compliance with federal and state
requirements; and serve as important partners in the development of
statewide linkages and coordination to combat state causes and
conditions of poverty. The structure of CSBG empowers states and locals
to work collaboratively, maximizing impact for America's communities.
Impact
CSBG is a positive federal investment in a national system to
address poverty that produces concrete results. Federal CSBG dollars
are used to build, coordinate, support, and strengthen anti-poverty
infrastructure across our communities. In Fiscal Year 2018,\1\ for
every $1 of CSBG, CAAs leveraged $8.27 from non-federal sources.
Leveraging funds allowed CAAs to expand highly successful and impactful
programs. Including all federal sources, non-federal sources, and
volunteer hours valued at the federal minimum wage, the CSBG Network
leveraged $21.97 of non-CSBG dollars per $1 of CSBG. Without CSBG, many
rural communities across America would not be able to implement
critical programs that address poverty for low-income families and
their communities. The CSBG network served more than 10.2 million
people with low incomes in Fiscal Year 2018. A robust appropriation
will expand impact and foster innovation within the network Below is a
snapshot of some quantitative impacts of CSBG:
---------------------------------------------------------------------------
\1\ FY 2018 data is the latest publicly available from the Office
of Community Services (OCS) within the Department of Health and Human
Services (HHS).
---------------------------------------------------------------------------
--915,230 households improved their energy efficiency and/or energy
burden in their homes.
--594,718 low-income seniors (65+) achieved or maintained an
independent living situation.
--253,422 children and youth who are achieving at a basic grade level
(academic, social and other school success skills.
--78,713 adults who improved their education levels.
--55,684 unemployed adults who obtained employment up to a living
wage.
--18,090 unemployed adults who obtained employment with a living wage
or higher.
Looking beyond the data, we see that the CSBG Network is delivering
innovative, comprehensive, and effective programs across the country
that uplift individuals, families, and their communities:
--Disaster Response and Recovery in Oregon: In September of 2020,
Oregon residents in Douglas and Josephine counties already
experiencing a surge in COVID-19 cases were faced with the
additional threat of unprecedented wildfires. Evacuating
families struggled to find adequate shelter and consistent
access to food as the fires raged across multiple impacted
counties. Already familiar with serving local low-income
communities, the United Community Action Network (UCAN)
immediately began providing disaster relief. UCAN partnered
with FEMA, local public health departments, and emergency
response centers to help homeless or unsheltered individuals
and families find safety. Unable to cook while evacuating,
families utilizing food assistance relied on expensive prepared
meals which quickly drained their resources. Despite the
extreme circumstances, UCAN continued to provide food, hygiene
products, and social services wherever space was available,
including parking lots and outside gas stations. While the
wildfires stoked confusion and separated families, UCAN
connected those who were displaced and supplied cellphones so
those affected could contact loved ones. UCAN was instrumental
in organizing the emergency response, providing critical
resources, and reconnecting those separated by disaster.
--Vaccination Coordination & Education in Wisconsin: In coordination
with Wisconsin's Vaccination Task Force, the Wisconsin
Department of Children and Families and the Wisconsin Community
Action Program Association (WISCAP) are training case managers
to help Wisconsin residents to navigate the COVID-19
vaccination process. Trainings cover vaccine scheduling through
the 2-1-1 Wisconsin phone service, a framework for discussing
vaccine confidence, and a review of wrap-around services
available to compliment vaccination. Through this coordination,
Wisconsin is leveraging the 2-1-1 service as a referral source
for hyper-local, trusted community member-driven vaccination
education. Wisconsin's CSBG network also applied for a COVID-19
Outreach Grant to better assist BIPOC and rural, low-income
people with vaccine hesitance or barriers to access like
transportation. This coordinated effort helped all programs
leverage vaccine rollout funding to create a broader reach
within local communities, increase access to vaccines, and
ultimately save lives.
--Flexible & Bundled Services in Michigan: Michigan's Bureau of
Community Action and Economic Opportunity (BCAEO) began
organized discussions around new services as soon as the CARES
Act was first introduced. Working regionally with local CAAs as
well as with Governor Whitmer's taskforce, BCAEO developed
contracts and procedures to expand services as soon as CARES
funding was available. Expanding their nutrition programs,
local agencies created online grocery stores so families with
medical, religious, or cultural dietary restrictions could
choose foods for delivery. CAAs also delivered quarantine-
boxes, packages of food and hygiene supplies that allowed
residents to shelter in place before making long-term
preparations. Agencies partnered with struggling local farmers
to provide fresh produce while also fully retaining their staff
during lockdowns by moving them to food warehouse & delivery
positions. At the same time, Michigan CAAs utilized
supplemental funding to provide more than 2,200 people with
internet-connected devices to access remote education,
employment opportunities, telehealth, and other critical online
resources.
Accountability
CSBG is bolstered by a Performance Management Framework to ensure
accountability at all levels of the network. This federally established
Performance Management Framework includes state and federal
accountability measures, organizational standards for Community Action
Agencies, and a Results Oriented Management and Accountability (ROMA)
system. Under the Performance Management Framework, CSBG state offices
gather and document outcomes for the CSBG Annual Report. Within this
reporting mechanism, National Performance Indicators are used across
the network to track and manage progress, empowering CAAs have the data
they need to improve services and innovate delivery. The ROMA system
engages local communities to strengthen their impact and achieve robust
results through continuous learning, improvement, and innovation.
Furthermore, CSBG State Offices monitor local agency performance and
adherence to organizational standards, providing training and technical
assistance to ensure continuously high-quality delivery of programs and
services.
In closing, we ask the committee to fund CSBG at no less than $800
million for FY 2022 and to increase client eligibility to 200% of the
Federal Poverty Level, ensuring that this nationwide network with a
nearly 60-year record of success continues to positively impact the
lives of vulnerable Americans. The structure of CSBG empowers States
and local agencies to address poverty in their communities, while
prioritizing the voices of people with low incomes in determining
solutions. CSBG is committed to the comprehensive accountability
mechanisms of the Performance Management Framework, ensuring effective
and responsible stewardship of funds at the Federal, State, and local
level. CSBG is producing tangible results, serving millions of
vulnerable Americans each year and empowering communities, families,
and individuals to achieve economic security, social mobility, and
racial justice. NASCSP looks forward to working with Committee members
to ensure CSBG continues to help families achieve these outcomes,
strengthening our communities and providing our most vulnerable
neighbors with security, dignity, and justice. Thank you.
Respectfully submitted.
[This statement was submitted by Beverly Buchanan, Board President,
National Association for State Community Services Programs.]
______
Prepared Statement of the National Association of Councils on
Developmental Disabilities
The National Association of Councils on Developmental Disabilities
(NACDD), a national membership organization for the State Councils on
Developmental Disabilities (DD Councils), appreciates the opportunity
to present this testimony. NACDD respectfully requests $89 million, the
level included in the President's FY22 budget request, for the DD
Councils within the Administration for Community Living (ACL) in the
Labor-HHS-Education appropriations bill for Fiscal Year (FY) 2022. We
also respectfully request that the following report language be
included in the Fiscal Year 2022 Labor, Health and Human Services,
Education Appropriations bill:
Technical Assistance.--The Committee provides not less than
$700,000 for technical assistance and training for the State
Councils on Developmental Disabilities. Such technical
assistance should be provided by an organization with
longstanding experience providing technical assistance to the
national network of state developmental disabilities councils
or similar Developmental Assistance and Bill of Rights Act
national programs. In addition, the agreement encourages ACL to
consult with the appropriate Developmental Disabilities Act
stakeholders prior to announcing opportunities for new
technical assistance projects and to notify the Committees
prior to releasing new funding opportunity announcements,
grants, or contract awards with technical assistance funding.
Funding for the DD Councils has obtained broad bicameral support
from members of Congress. This funding request also has broad support
from the disability community. The Consortium for Citizens with
Disabilities, the largest coalition of national organizations working
together to advocate for people with disabilities, submitted a support
letter to this committee dated April 26, 2021.
Authorized by the Developmental Disabilities Assistance and Bill of
Rights Act (DD Act), DD Councils work collaboratively with the
University Centers for Excellence in Developmental Disabilities, and
the Protection and Advocacy program for Developmental Disabilities, to
``assure that individuals with developmental disabilities and their
families participate in the design of and have access to needed
community services, individualized supports, and other forms of
assistance that promote self-determination, independence, productivity,
and integration and inclusion in all facets of community life, through
culturally competent programs.'' \1\ Appointed by Governors, and
consisting of at least 60 percent of people with DD and their families,
DD Councils assess problems or gaps in the I/DD system and design
innovative solutions that make real changes to social systems such as
employment, transportation, education, healthcare, housing and more, to
fully integrate people with I/DD into society.
---------------------------------------------------------------------------
\1\ 42 U.S.C. 15001(b).
---------------------------------------------------------------------------
The request for an increase in funding for FY2022 is informed by
the tragedy and lessons learned from last year's COVID-19 pandemic and
the spotlight it placed on circumstances of everyday living for people
living with intellectual or developmental disabilities (I/DD) that
present obstacles. For decades since the passage of the DD Act and
later the Americans with Disabilities Act, the whispered concerns about
the dangers of living with I/DD in isolation and stripped of critical
supports were realized when the pandemic hit. Several studies showed a
link between having an I/DD and a greater risk of contracting and dying
from COVID-19, with one study finding having an intellectual disability
was the strongest independent risk factor for presenting with a Covid-
19 diagnosis and the strongest independent risk factor other than age
for Covid-19 mortality. The Centers for Disease Control and Prevention
identified social factors which increased the risk of COVID-19
transmission including: relying on direct support workers and families,
difficulties understanding information and preventative measures, and
difficulty communicating symptoms of the illness. The circumstances of
simply living with I/DD means that people are struggling to simply
live, not only during pandemics but every day of their lives. For
example, it is true that relying on direct support workers and families
is an obstacle to surviving COVID, but it is also an obstacle to
obtaining employment, accessing transportation, and most activities
people without disabilities take for granted.
The DD Councils support innovative programs to promote self-
determination and create systemic pathways to independent living to
keep people with I/DD safe during public health emergencies and to help
them live their fullest lives in the community long after the pandemic.
DD Councils direct resources through partnerships with local non-
profits, businesses, and state and local governments, to overcome
obstacles to community living for people with I/DD. States and
territories rely on DD Councils to turn fragmented approaches into
innovative and cost-effective strategies to increase the percentage of
individuals with I/DD who become independent, self-sufficient and
integrated into the community. Examples of DD Council projects include:
partnerships to increase competitive and integrated employment,
campaigns promoting access to qualified direct support workers,
programs for successfully transitioning to independent living, advocacy
for access to affordable housing, training to build leadership and
advocacy skills, and more. DD Council members also provide a critical
and unique role in educating state and local policymakers by directly
participating in the design of state and local government-funded
supports and services affecting their lives.
DD Councils promote community living in the states through narrowly
tailored, state-specific initiatives for emerging issues. Every DD
Council pivoted during COVID-19 to meet immediate and critical needs.
For example, in response to the hardship that COVID-19 has placed on
people's ability to stay connected and engaged, the Washington State
Developmental Disability Council invested in grants including:
providing laptops and prepaid data cards for internet access for those
without technology; promoting healthy living during COVID; and
combating social isolation. At the same time, their longer-term plans
were implemented. For example, as part of their five-year plan, the
Missouri Developmental Disabilities Council identified affordable and
accessible housing is an essential need for people with I/DD. The
council supported community initiatives that resulted in persons with
developmental disabilities having opportunities for housing including
the Missouri Inclusive Housing Development Corporation (MoHousing).
Thank you for consideration of our request.
______
Prepared Statement of the National Association of
Drug Court Professionals
Chairwoman Murray, Ranking Member Blunt, and distinguished members
of the subcommittee, I am honored to have the opportunity to submit my
testimony on behalf of this nation's nearly 4,000 treatment court
programs and the 150,000 people the programs will connect to lifesaving
addiction and mental health treatment this year alone. Given the
overlapping crises of substance use and the COVID-19 pandemic, I am
requesting that Congress provide funding of $105 million for the Drug
Treatment Court Program at the Department of Health and Human Services,
Substance Abuse and Mental Health Services Administration for fiscal
year 2022.
I serve as a superior court judge in Lewis County, Washington,
where, for the entirety of my tenure as judge, I have presided over our
county's treatment court programs, including drug courts. I have never
participated in a more effective approach to promoting public health
while also remaining steadfast to the promise of the justice system to
protect public safety. Strong empirical evidence shows time after time
that treatment courts not only reduce crime, but also save lives and
families by connecting participants to evidence-based treatment
services and recovery support.
Participants like Brant. Before coming to our program, he spent
much of his life cycling in and out of the justice system because of an
addiction that began in his early twenties. By the time he came to our
program, he had been to jail seven times, with more on the horizon
unless something changed. Our treatment court program provided the
accountability and treatment that Brant needed to change.
In our program, Brant, like the rest of our participants, was
assessed and given an individualized treatment plan designed by
substance use treatment professionals using evidence-based methods,
including medication-assisted treatment where appropriate. Together, in
concert with the multidisciplinary treatment court team who ensured
Brant received the services and accountability he needed to succeed, we
set a goal of recovery for him, not another costly and ineffective
stint behind bars.
Today, Brant is not only living that goal, he's doing what he can
to help others achieve the same. He works for an organization that
conducts outreach to vulnerable populations with substance use
disorders and helps them get their lives back on track, with a special
focus on homeless veterans. He also serves as the president of the
nonprofit organization that helps support the Lewis County Drug Court,
ensuring the lifesaving work of our program continues well into the
future.
I have worked in treatment courts since 2004, when I helped launch
Lewis County's adult drug court as chief criminal deputy in the
prosecutor's office. Subsequently, as the chief criminal deputy of
neighboring Thurston County, I supervised our adult drug court, mental
health court, and veterans court units. Since then, I have watched many
of the most helpless individuals in our justice system overcome their
substance use or mental health disorder, regained their lives, and
became productive citizens. Most go on to raise families, begin growing
careers, and help others in the similar difficult positions they once
found themselves in. Without hesitation, I credit the treatment court
model for the health and safety of these individuals.
Lewis County is a rural, relatively quiet part of southwestern
Washington. But we are not immune from the grips of the twin crises
currently gripping the nation from coast to coast: the substance use
epidemic and the ongoing effects of COVID-19, including isolation and
economic devastation. Treatment courts, such as adult drug courts,
veterans treatment courts, family treatment courts, and others, offer a
public health and public safety response to these crises by expanding
and enhancing substance use treatment capacity to serve more
individuals in their communities.
With overwhelming empirical evidence showing their effectiveness,
it is easy to see that treatment court programs across the country
merit continued funding. The Government Accountability Office finds the
drug court model reduces crime by up to 58%. Further, the Multi-Site
Adult Drug Court Evaluation conducted by the Department of Justice
confirmed drug treatment courts significantly reduce both drug use and
crime, as well as finding a cost savings averaging $6,000 for every
individual served. Additional benefits include improved employment,
housing, financial stability, and reduced foster care placements.
Brant is not alone in his success. Treatment courts in this country
have connected 1.5 million people who have lifesaving mental health and
substance use disorders with treatment options best suited to them.
Together, the court team offers the tools to overcome substance use
disorder and past trauma to create meaningful, healthy relationships.
Continued support from the Drug Treatment Court Program at the
Department of Health and Human Services ensures the nearly 4,000
treatment courts in the United States today provide critical treatment
services to save lives and reunite families. But we know there are many
more who still need this opportunity. I strongly urge this committee to
recommend funding of $105 million to the Drug Treatment Court Program
in fiscal year 2022, so treatment courts in Washington and beyond can
continue providing lifesaving substance use treatment services.
[This statement was submitted by Hon. Andrew Toynbee, Judge,
Superior Court of Lewis County, Washington, Chehalis, Washington.]
______
Prepared Statement of the National Association of
Emergency Medical Technicians
Thank you, Chairwoman Murray, Ranking Member Blunt, and
distinguished members of the Subcommittee. My name is Bruce Evans, and
I am the President of the National Association of Emergency Medical
Technicians (NAEMT). I am also a fire chief leading a fire-based EMS
organization in a super rural area of Southwest Colorado--12,000
residents in 264 square miles.
Founded in 1975 and over 70,000 members strong, NAEMT represents
our nation's frontline EMS practitioners, who provide critical,
lifesaving services to communities nationwide, especially in rural,
frontier, and other hard-to-reach areas. On behalf of our organization,
thank you for your ongoing support of EMS professionals. NAEMT would
like to offer our views on the Subcommittee's FY 2022 bill. At the
outset, we write to ask the subcommittee to provide robust funding for
the SIREN Rural EMS Equipment and Training Assistance (REMSTEA) program
within the Department of Health and Human Services' (HHS) Substance
Abuse and Mental Health Services Administration (SAMHSA).
This testimony is submitted just a few weeks after the 46th Annual
EMS Week, which occurred from May 16--May 22, 2021. The goal of EMS
Week is to thank paramedics, EMTs, and the entire EMS workforce for
their services and sacrifices. However, EMS professionals do not just
want a pat on the back--like the rest of our members, I am writing to
continue to raise public awareness about the critical funding shortfall
of EMS in the communities we serve. This urgent request aligns with the
spirit of EMS Week.
Passed in the 2018 Farm Bill, the SIREN/REMSTEA grant program
supports rural public and nonprofit EMS agencies in their efforts to
complete their mandate to provide critical emergency medical care to
all of the residents in the communities they serve. The grants help
rural EMS agencies train and retain staff and purchase equipment, among
filling other needs. Community demands keep growing: each year, fire
departments and EMS agencies respond to more than 20 million calls for
emergency services. While the COVID-19 pandemic exacerbated the plight
of these agencies, EMS practitioners and agencies were facing severe
challenges before the virus' outbreak. This can be attributed, in part,
to greater distances between health care facilities and low
reimbursement rates. The most pressing impact is the decline of
available medical care in rural communities, which has heightened the
need for already-stretched EMS agencies to perform these lifesaving
services. Again, this foreboding and bleak landscape existed even
before the onset of the pandemic, which has strained the social safety
net that EMS professionals provide.
COVID-19 made an already growing problem much worse. In FY2020 and
FY2021, your Committee provided $5 million and $5.5 million for SIREN
grants, respectively. However, the program requires a substantial
increase in funds to make sure our personnel have the equipment and
training they need. Social distancing and ``stay-at-home'' protocols
because of the pandemic complicated income streams for these agencies.
Many rural EMS agencies rely heavily on community fundraising efforts,
such as bingo, raffles, and community barbeques. At the same time,
support from localities whose tax revenue base has dramatically
declined, further hindering EMS agencies' ability to fill their
coffers. Beyond smaller revenue streams, costs have gone up, especially
as EMS agencies have been paying higher prices for personal protection
equipment (PPE) throughout the pandemic.
Rural EMS organizations, like mine in Colorado, have
disproportionately suffered from shrinking revenue streams and
increased demand before the pandemic and now, especially as it relates
to synthetic opioid overdoses, which have skyrocketed and do not seem
to be slowing down. Ambulance crews that support the most far-flung
areas of our country are running out of money and personnel. Because of
the especially demanding work that rural EMS organizations shoulder,
they are struggling to stay afloat at a much higher rate than their
more urban counterparts. This challenge is not limited to one region of
the country; rather, rural EMS organizations across the board are more
likely to shut their doors, leaving their residents without reliable
access to local ambulance service. Ultimately, without the support this
grant program provides, many more local EMS operations will likely have
to close their doors.
The result is, unfortunately, predictable: increasing workforce
shortages as EMS personnel become increasingly burnt out, face
shrinking compensation, and are constantly exposed to unpredictable and
dangerous environments. In short, more money is needed to bring more
people aboard to ensure that our professionals are provided a safe,
healthy, and respectful work environment, and that their EMS agency can
effectively serve their communities. The enhanced funding for the
SIREN/REMSTEA program will go to good use, especially as our country
and economy recover from the economic and health care crisis brought on
by the pandemic.
Beyond the demonstrated need, EMS personnel made good use of the
funds allocated under the FY2020 and FY2021 spending bills. For FY2020,
SAMHSA awarded REMSTEA grants ranging from $92,000 to $200,000 to
approximately 27 EMS agencies across the country for recruitment and
training purposes. In December 2020, SAMHSA announced the potential to
grant awards to another 27 rural EMS applicants. Rural EMS agencies are
in dire need for additional support--we can assure you that our
organization's members will not leave money allocated by Congress on
the table.
On behalf of our 70,000 members who live and work in every state
across our country, thank you again for supporting our brave men and
women who provide important roles in the health care ecosystem. SIREN/
REMSTEA grants will certainly help them do their jobs to their fullest
ability.
[This statement was submitted by Bruce Evans, MPA, NRP, CFO, SPO,
President, National Association of Emergency Medical Technicians.]
______
Prepared Statement of the National Association of
Nutrition and Aging Services Programs
Our ask for FY 2022 is for a minimum total of $1.9 billion for the
three Older Americans Act (OAA) Title III-C Nutrition Programs, divided
approximately as follows:
--Congregate Nutrition Services (Title III C-1)--$965 million
--Home-Delivered Nutrition Services (Title III C-2)--$726 million
--Nutrition Services Incentive Program (NSIP) (Title III)--$211
million
We can more than justify the need for this funding level. It is
important to understand the reality of how the pandemic impacted these
programs. The OAA nutrition programs endured a wholescale conversion of
the operations because of the COVID-19 pandemic. Before the pandemic,
according to the Administration for Community Living's AGID database,
more than twice as many older adults were served in the congregate
program as in the home-delivered nutrition program. The pandemic caused
the transition of almost all congregate program participants to the
home-delivered nutrition program.
This conversion resulted in programs encountering immediate
increases in costs for food, transportation and personnel, since many
relied on older volunteers who were unable to continue their work.
Price increases have been particularly felt in those transportation
costs, including gasoline prices. Programs went from serving hundreds
of participants per day in one location to getting meals to hundreds of
individual locations. Gasoline prices have shown a 49.6 percent
increase over the last year, including a 9.1 percent increase between
just April and May.
Further, in addition to providing additional funding during the
pandemic, Congress also has approved some needed flexibilities to allow
these programs to seamlessly convert. The most impactful of these was
an updated definition of ``homebound,'' allowing any older adult forced
to shelter in place to be eligible for a home-delivered meal,
overriding any previous state restrictions. This has led to tremendous
increases in demand. In fact, a survey conducted by Meals on Wheels
America showed an average of 95 percent increase in demand in the early
months of the pandemic, including 80 percent of surveyed programs
reporting doubling of requests for home-delivered meals. While demand
has stabilized to some extent, it remains at a national average of a 60
percent increase over pre-pandemic levels. Local programs also reported
that operating costs will likely remain high for the foreseeable
future, and nine in 10 home-delivered meals programs reported continued
unmet need for home-delivered meals in their community. Nearly a third
of these programs said they would need to nearly double or more than
double their home-delivered efforts in the future to serve this unmet
need.
This is perhaps the greatest justification for this funding. We do
not want to see older adults crashing into and falling over this
``cliff'' of funding running out while the need for service continues.
We do not want to have our dedicated personnel in the field be forced
to remove older adults in need from their programs, knowing what the
health consequences would be.
This funding request is premised on the fact that while the
pandemic may be easing, it is not over by any means. Without question,
the emergency funding provided to this nutrition network has been used.
These funds we request will absolutely also be used.
It should also be noted that nutrition programs were creative and
innovative in their use of emergency funds, establishing partnerships
with restaurants, food delivery services, drop-ship services and the
like in order to stretch their funding as far as it would go. But
public-private partnerships do involve resources from both sides.
Supporting our funding request for FY 2022 will allow these innovations
and partnerships to continue and expand.
Another justification for this funding request must be what it can
do to help alleviate the three evils of hunger, food insecurity, and
malnutrition in older adults. We have documented information on major
increases in food insecurity during the pandemic. We were also acutely
aware that even before the pandemic, one in two older adults were at
risk of or were already malnourished. The provision of a daily meal to
an older adult in a homebound setting can often be the main source of
their nutrition for that given day. Said another way, if you remove
that meal, that older adult simply may not eat at all.
A continued investment in the OAA nutrition programs allows us an
important intervention for those older adults who are socially
isolated. Funding provided during the pandemic went well beyond just
providing a meal. Our nutrition network responded by developing
critically important programs to maintain contact with older adults who
suddenly found themselves not being able to have their normal daily
socialization at their congregate program. They provided telephone
reassurance calls as well as higher-tech approaches to maintaining
contact such as virtual book clubs, exercise classes, and nutrition
education. These services, like the food provided, need to be continued
in the year ahead.
We were also especially pleased that the American Rescue Plan Act
included funding to allow the aging network to assist in the effort to
get older adults vaccinated. At the time FY 2022 begins, we will be
entering flu and pneumonia season. We need to ensure that we continue
to provide the aging network with resources to aid older adults in
getting the vaccines they need to prevent these illnesses.
In addition, we are all striving for the day when congregate
nutrition sites, senior centers and adult day centers that provide
meals can reopen. Of course, this can only be done with proper regard
for health and safety rules and ordinances. NANASP and our colleagues
at the National Council on Aging are surveying our members to find out
what costs facilities will incur both to open and remain open. The
results are concerning--many programs are reporting $15,000 in costs or
more per facility--and these expected costs go outside of most budgets.
We hope that this funding can be significant and flexible enough to
allow some to be used to facilitate reopening and/or that funding for
these facilities be included in any major infrastructure bill Congress
may produce with the President.
Finally, we implore this Subcommittee to think about what has
unfolded in the past year with respect to different funding sources.
Aging network programs must report their spending of regular FY 2021
funding as well as four streams of emergency funding and expected FY
2022 funding. We strongly request that you communicate through this
legislation that while accurate reporting is necessary and important,
steps should be taken by the Administration to ensure that the
reporting process is as simplified as possible to ensure that programs
are not spending much of their limited staff hours and resources on
this onerous task.
Next year, this wonderful Older Americans Act nutrition program
will celebrate its 50th anniversary. Without question, its 49th year
has likely been its toughest. Yet the fact that the OAA nutrition
program went seamlessly through an unexpected full-scale conversion
speaks volumes about the dedication of nutrition service providers, who
deserve our sincere thanks. They pivoted and persevered despite their
personal struggles and fears about the virus. While not technically
first responders, they were first to respond to one critical need for
older adults--nutrition. In short, they always have the best interest
of the older adults they serve front and center, as has this
Subcommittee. We ask for you to keep this interest in mind again in
this incredibly challenging time so we can be prepared for the final
phases of the pandemic and all the related downstream issues there may
be.
In closing, in the words of a program director from a recently-
published New York Times article on OAA nutrition programs:
``[Program administrators] worry that if Congress doesn't sustain
this higher level of appropriations, the relief money will be
spent and waiting lists will reappear.
`There's going to be a cliff,' Mary Beals-Luedtka [director of the
area agency on aging serving northern Arizona] said. `What's
going to happen next time? I don't want to have to call people
and say, `We're done with you now.' These are our
grandparents.' ''
______
Prepared Statement of the National Association of
Secondary School Principals
The National Association of Secondary School Principals (NASSP)
appreciates the opportunity to submit the following testimony for the
record to the Senate Appropriations Subcommittee on Labor, Health and
Human Services, Education, and Related Agencies. As the premier
national organization and voice for middle level and high school
principals, assistant principals, and other school leaders, NASSP seeks
to transform education through school leadership, recognizing that the
fulfillment of each student's potential relies on great leaders in
every school committed to the success of each student.
As you develop the fiscal year (FY) 2022 appropriations bill for
the U.S. Departments of Labor, Health and Human Services, Education,
and Related Agencies, NASSP encourages you to help every American
student achieve success and be ready for college, career, and life by
prioritizing funding for Supporting Effective Instruction State Grants,
the School Leader Recruitment and Support program, the Literacy for
All, Results for the Nation (LEARN) program, and Student Support and
Academic Enrichment grants.
NASSP urges the subcommittee to allocate $3.00 billion for the
Supporting Effective Instruction State Grants program, Title II, Part A
(Title II-A) of the Every Student Succeeds Act (ESSA). This program
provides states and school districts with formula funding that ensures
that educators, principals, and school leaders receive the professional
learning and leadership skills needed to support every student.
Research continues to show that Title II-A's investments in
educators pays significant dividends in terms of improving educational
practice and increasing student achievement. School districts use Title
II-A funding to implement ESSA's rigorous definition of professional
development that embodies the important transition from scattershot,
one-off professional development workshops and sessions to
collaborative, ongoing, job-embedded professional learning such as
coaching, mentoring, and professional learning communities (PLCs).
Research supports the positive effect of the kinds of professional
development defined in ESSA. For example, key studies show that
coaching helps teachers improve their practice faster. A 2018 meta-
analysis, which examined 60 rigorous studies of coaching, found large
positive effects of coaching on teachers' instructional practices.
Across 43 studies, researchers found that coaching accelerates the
growth that typically occurs as one moves from novice to veteran
status. Additionally, multiple researchers have documented that
teachers who collaborate in PLCs to continuously improve their practice
and their students' learning experiences have a measurable positive
impact in schools. A 2009 study that took place in New York City
documented student achievement gains across grade levels when teachers
engaged in purposeful, content-focused interactions.
Title II-A's support for principal and school leader professional
learning is also critical, as research shows a strong correlation
between high-quality principals and student achievement and teacher
retention. A March 2021 Wallace Foundation paper stated that a review
of two decades of evidence--including six quantitative, longitudinal
studies involving 22,000 principals--found that ``principals have large
effects on student learning, comparable even to the effects of
individual teachers. A separate 2016 review of 18 studies meeting
ESSA's Tiers I-III evidence standards concluded that ``school
leadership can be a powerful driver of improved education outcomes.''
This research buttresses earlier studies that concluded that principals
are second only to teachers as the most important school-level
determinant of student achievement. Other research suggests that
schools led by high-quality principals have lower teacher turnover
rates.
While the federal government's investment in Title II-A has proven
to be much needed and welcome, the COVID-19 pandemic laid bare the need
for higher levels of support for our nation's educators. A significant
increase to $3.00 billion for Title II-A will provide schools and
districts with crucial funds to address new and existing challenges
induced or exacerbated by the pandemic. A larger investment in Title
II-A will help accelerate student learning, curb teacher and principal
shortages by recruiting new individuals into the educator workforce,
provide supports to keep educators in the profession, keep class sizes
low, and provide mental health and wellness support to our nation's
educators as they reenter classrooms full time for the upcoming school
year.
NASSP urges the subcommittee to support our nation's school leaders
through renewed funding for the School Leader Recruitment and Support
Program (SLRSP). Authorized under ESSA and funded at $14.5 million in
FY 2017, SLRSP is the only federal program specifically focused on
investing in evidence-based, locally-driven strategies to strengthen
school leadership in high-need schools. Unfortunately, this program has
received no funding in the last several fiscal years. Recently though,
President Joe Biden released his FY 2022 budget, where he called for
the program to receive $30 million, a number that NASSP requests this
committee support.
SLRSP empowers states and school districts, individually or in
partnership with nonprofits or institutions of higher education, to
accelerate the recruitment, preparation, support, and retention of
dynamic school leaders who have a measurable, positive effect on
student achievement in high-need schools. Through this program,
aspiring principals gain access to high-quality preparation programs,
sitting principals receive critical professional development supports,
and thousands of teachers--along with hundreds of thousands of
students--have the opportunity to work and learn in schools where
school leaders have the tools to help them maximize their potential.
Funding SLRSP at $30 million will allow proven programs to train more
principals to lead during this critical time, provide additional
support to current principals, and ultimately lead to better support
for teachers and students.
As we continue working with states, districts, and schools on how
best to serve students and teachers as schools begin close out the
current school year and look toward the next, it is important we
recognize that investments in school leadership are critical to
addressing learning loss and meeting students' social and emotional
learning needs. Additionally, investments in leadership are extremely
cost effective when you consider that investing in one principal is
actually an investment in the 25 teachers and 500 students they, on
average, support. A recent report from The Wallace Foundation states,
``Principals really matter. Indeed, it is difficult to envision an
investment with a higher ceiling on its potential return than a
successful effort to improve principal leadership.''
While investments in school leadership will have a significant
impact on addressing lost instructional time for students, additional
investments in critical programs will also be necessary to help student
achievement. That is why NASSP also calls for the subcommittee to
provide $500 million for the LEARN program, which builds on the success
of the Striving Readers Comprehensive Literacy (SRCL) program.
Research has already started to highlight the pandemic's impact on
students' literacy skills. McKinsey & Company found that students
taking formative assessments in 2020 learned only 87% of the reading
that grade-level peers would typically have learned by the fall.
Students lost the equivalent of one-and-a-half months of learning in
reading on average, but in schools that predominantly serve students of
color, the learning loss was especially acute. The LEARN program builds
on the success of the SRCL program where states implementing
comprehensive literacy plans have seen significant improvements in
English language arts achievement in districts and schools serving
disadvantaged students.
Eleven states (Georgia, Kansas, Kentucky, Louisiana, Maryland,
Minnesota, Montana, North Dakota, New Mexico, Ohio, and Oklahoma), the
Bureau of Indian Education, and four territories received SRCL grants
in 2017, and an additional 13 states (Alaska, Arkansas, California,
Georgia, Hawaii, Kentucky, Louisiana, Minnesota, New Mexico, Ohio,
Rhode Island, and South Dakota) received grants in 2019 under the now-
named Comprehensive Literacy State Development program. With these
grants, states are able to support high-quality professional
development for teachers, principals, and specialized instructional
support personnel to improve literacy instruction for struggling
readers and writers, including English-language learners and students
with disabilities.
The literacy skills our students need today are much more complex
than they were 50 years ago. Creating a globally competent workforce
depends on students using their reading and writing skills to develop
important abilities in areas such as math, science, technology, and
manufacturing. Yet despite the fundamental importance of reading and
writing, only 35% of fourth-grade students and 34% of eighth-grade
students performed at or above the proficient level in the reading
assessment of the National Assessment of Educational Progress--the
Nation's Report Card.
Of the more than 523,000 students who leave U.S. high schools each
year without a diploma, many have low literacy skills. Research clearly
demonstrates that a high-quality, literacy-rich environment beginning
in early childhood is one of the most important factors in determining
school readiness and success, high school graduation, college access
and success, and workforce readiness.
A strong federal commitment to literacy is imperative. LEARN
supports states in a comprehensive, systemic approach to strengthen
evidenced-based literacy and early literacy instruction for children
from early learning through high school and supports district capacity
to accelerate reading and writing achievement for all students.
Lastly, NASSP urges the subcommittee to allocate $2.00 billion for
the Student Support and Academic Enrichment (SSAE) grant program
authorized by Title IV-A of ESSA for FY 2022. This would be a $780
million increase over the FY 2021 enacted level. Title IV-A is a
flexible grant that supports state and district efforts to: 1) support
safe and healthy students by providing comprehensive mental and
behavioral health services and implementing violence prevention
programs, trauma informed care, school safety trainings, and other
evidenced-based initiatives; 2) increase student access to a well-
rounded education, such as STEM, computer science and accelerated
learning courses, career and technical education, physical education,
music, the arts, foreign languages, college and career counseling,
effective school library programs, and social and emotional learning;
and 3) provide students with access to technology and digital learning
materials and educators with professional development and coaching
opportunities necessary to effectively use those resources.
Over the last four fiscal years, on a bipartisan basis, Congress
has provided a $4 billion investment for Title IV-A, which has allowed
districts to meaningfully invest in programs that provide direct
educational services and equitable supports to students. Its
flexibility has allowed districts to provide funding for critical
programs that support educators, school leaders, and students. As
district leaders continue to leverage the flexibility of the SSAE
grants, they are eager to plan for the continuance and/or expansion of
existing programs and services, and to create new programs.
To address unprecedented interruptions to learning caused by COVID-
19, we call on Congress now to go beyond what was authorized in ESSA by
providing $2 billion for the SSAE block grant. This will allow
additional school districts, especially in rural areas, to make
investments in not just one, but all three areas that this grant
supports. Right now--more than ever--districts need the continued
investments in the Title IV-A program. This pandemic has made clear
that districts face a wide range of unique challenges, whether it's
ensuring all children have access to technology for remote or blended
learning or the ability to provide mental health supports from afar. As
school systems prepare for the return to classrooms next school year,
they will need the flexibility of Title IV-A funds to provide social
and emotional learning programs, engaging well-rounded classes like
music and physical education, and active learning opportunities enabled
through technology.
NASSP thanks you again for the opportunity to share these thoughts
and information with you, and also thanks you for your continued work
to support our nation's students and educators. To discuss this
testimony further or if you have any questions, please contact NASSP's
senior director of federal engagement and outreach, Zach Scott, at
[email protected].
______
Prepared Statement of the National Association of
State Head Injury Administrators
On behalf of the National Association of State Head Injury
Administrators (NASHIA), thank you for the opportunity to submit
testimony regarding the fiscal year 2022 appropriations for federal
programs that impact approximately 2.87 million Americans who are
treated annually in emergency department visits and hospitals for a
traumatic brain injury (CDC, 2014). To address their needs, NASHIA is
requesting increased funding for programs authorized by the Traumatic
Brain Injury (TBI) Program Reauthorization Act of 2018 and administered
by the U.S. Department of Health and Human Services' (HHS)
Administration for Community Living (ACL) and the Centers for Disease
Control and Prevention's National Center for Injury Prevention and
Control (NCIPC). We also support additional funding for the ACL's
National Institute on Disability, Independent Living, and
Rehabilitation Research (NIDILRR) program authorized by the Workforce
Innovation and Opportunity Act (WIOA) of 2014, and which funds TBI
Model Systems and TBI research. NASHIA is requesting:
--$12 million additional funding for the ACL TBI State Partnership
Grant Program to provide funding to all states, territories and
District of Columbia;
--$6 million additional funding for the ACL TBI Protection & Advocacy
Grant Program to increase the amount of the awards; and
--$5M additional funding for the CDC's NCIPC to establish and oversee
a National Concussion Surveillance System as authorized by the
TBI Program Reauthorization Act of 2018.
NASHIA is also requesting a funding increase of $6.6 million to
expand the NIDILRR TBI research capacity through the TBI Model Systems
(TBIMS):
--To increase the number of TBIMS from 16 to 18 ($1 million each),
while increasing per center support by $200,000;
--$1 million to expand TBIMIS collaborative research projects from 1
to 3; and
--$100,000 to increase funding for the National Data and Statistical
Center in order to gain information for valuable research.
Each year, a substantial number of Americans are injured due to
motor vehicle crashes, falls, military-related injuries, violence,
industrial injuries, sports-related injuries and other injuries that
cause cognitive, emotional, physical, sensory and health-related
problems resulting in unemployment and loss income; homelessness;
incarceration; and institutional and nursing home placement due to lack
of community alternatives. While recent trends have noted the
increasing number of Americans with TBI-related disabilities among
older adults due to falls, the COVID-19 pandemic is raising alarms
regarding those who are infected who may experience hypoxia due to the
deprivation of oxygen, resulting in brain damage that may necessitate
the need for rehabilitation to regain functioning and ongoing supports
should functioning not be restored. In addition, the increased risk of
domestic and intimate partner violence during the time of the ``stay at
home'' orders put people at risk for sustaining a brain injury from the
abuser hitting the head, slamming the head against the wall or from
near strangulation. As we emerge from the pandemic, the impact on both
those at risk for a brain injury and for those with a brain injury will
certainly become more apparent.
This year has been especially challenging for individuals with
brain injury and their families. States have reported that brain injury
program participants have cancelled services due to the fear and
anxiety that COVID-19 has caused them. At the same time, providers have
experienced loss of income as the result of not being able to perform
contractual duties due to the restrictions. As a result, states have
witnessed increased anxiety and self-isolation among individuals with
brain injury. Thus, the federal funding requested is critical to assist
states with issues that emanate from the pandemic, as well as to
address the increased number of brain injuries due to an aging
population and other factors.
administration for community living--tbi act programs
The ACL TBI State Partnership Grant Program is the only program
that assists states in building and expanding service capacity to
address the complex needs associated with brain injury that generally
require the coordination of multiple systems (e.g., medical,
rehabilitation, education, vocational, behavioral health, Medicaid) and
payers (e.g., insurance, Workers' Comp, state and federal programs).
Twenty seven states are ending their grant activities. We are
requesting additional funding so that all states, territories and
District of Columbia may receive funding to address gaps in services
within their states.
These grants also help to carry out the ACL priorities to increase
direct services, including home and community-based services;
accelerating COVID-19 recovery; supporting caregivers; and advancing
equity.
acl tbi state protection & advocacy (patbi) program
The ACL Federal Protection and Advocacy TBI (PATBI) program is a
formula grant that provides $4 million total in funding for the 57 P&As
in the United States, its territories and the Native American
Protection and Advocacy Project in order to provide: (1) information,
referrals, and advice; (2) Individual and family advocacy; (3) legal
representation; and (4) specific assistance in self-advocacy. The
requested amount will increase the amount awarded to state and PATBI
grantees.
centers for disease control and prevention--national center on injury
prevention and control
CDC's National Injury Center initiated a pilot study as a first
step in implementing a national surveillance system to determine the
extent of mild brain injury or concussions in this country. Most
individuals with a concussion are treated in an emergency department or
physician's office and may not be reported in other data systems that
capture the number of Americans who are hospitalized with moderate to
severe TBI. Subsequently, Congress included $5 million authorization to
implement the National Concussion Surveillance System within the TBI
Program Reauthorization Act of 2018.
Last year, the Government Accountability Office (GAO) issued a
Report to Congress that found that data on the overall prevalence of
brain injuries resulting from intimate partner violence are limited and
that such data is needed to better understand the problem to ensure
that resources are targeted appropriately to address these issues. In
2013, the Institute of Medicine (IOM) and the National Research Council
released an extensive report on sports-related concussions in children
and teens and also examined sports-related concussions among military
dependents, as well as concussions in military personnel ages 18 to 21
that result from sports and physical training at military service
academies or during recruit training. The report noted that limited
data is available and recommended that CDC oversee a national
surveillance system to accurately determine the incidence of sports-
related concussions.
We strongly support funding to implement a national surveillance
system to help states, federal and national partners with needed data
to address prevention, identification, and treatment for concussions.
acl's national institute on disability, independent living, and
rehabilitation research (nidilrr)
NIDILRR supports innovative projects and research in the delivery,
demonstration, and evaluation of medical, rehabilitation, vocational,
and other services designed to meet the needs of individuals with TBI
through TBI Model Systems grants. Each TBI Model System contributes to
the TBI Model Systems National Data and Statistical Center (TBINDSC),
participates in independent and collaborative research, and provides
valuable information and resources. This research is critical to help
TBI providers to better deliver services that result in good outcomes.
In closing, NASHIA, as a nonprofit organization, works on behalf of
states to promote partnerships and build systems to meet the needs of
individuals with TBI with the goal of all states having resources to
assist individuals with TBI to return to home, community, work and
school after sustaining a brain injury. Federal funding is critical to
help states in that endeavor, including data and research to support an
effective delivery system. We urge you to consider increasing funding
for the ACL TBI Program (state and protection & advocacy grant
programs), for the ACL NIDILRR program to expand TBI research, for CDC
to establish a National Concussion Surveillance system.
Thank you for your continued support. Should you wish additional
information, please do not hesitate to contact: Susan L. Vaughn,
Director of Public Policy at [email protected], or Becky Corby, NASHIA
Government Relations at [email protected].
______
Prepared Statement of the National Association of State Long-Term Care
Ombudsman Programs
Chairman Murray and Ranking Member Blunt, I present this testimony
on behalf of the nearly 74,000 residents in Washington State's long-
term care facilities and in collaboration with the National Association
of State Long-Term Care Ombudsman Programs (NASOP). Thank you for your
past support of State Long-Term Care Ombudsman Programs (SLTCOPs) and
the at-risk individuals that they serve, particularly in the CARES Act.
As you know, our work to serve the residents of long-term care
facilities under the terrible cloud of the COVID-19 pandemic has been
extremely challenging. We are emerging from this period facing many
crises in facilities across the nation, but we are determined to
protect the rights of residents, resolve their complaints and service
problems, and work with facilities to improve the quality of care, the
roles in which we ombudsmen have been entrusted.
I submit this statement and the funding recommendations for the
Fiscal Year 2022 for SLTCOPs administered through the Administration
for Community Living, Department of Health and Human Services, to
include:
--$65 million to support our work with residents of assisted living,
board and care, and similar community-based long-term care
settings as these are less regulated and residents often need
greater advocacy;
--$70 million for our current core obligation to respond to
tremendous need, ensuring residents have regular and timely
access to our program; and
--$20 million under the Elder Justice Act for training and services
to address increasing abuse, neglect, and exploitation,
including related to staff that are part of the opioid crisis.
Let me explain why our program is requesting this funding. I will
start by letting you know why we ombudsmen are so passionate about our
work. Our mission is to protect the health, safety, welfare, and rights
of our nation's older adults and individuals with disabilities living
in nursing homes and assisted living facilities. We protect the
residents' rights to be treated as individuals with autonomy, choice,
independence, and access to quality health care. We believe that in a
just society, all people would have their needs met. LTC Ombudsmen are
paid professionals who recruit, train, and oversee teams of local
volunteers who want to give back to their communities. The advocacy we
provide is the first line of protection for thousands of elders living
in licensed long-term care facilities. Increased consistent funding is
needed for the SLTCOP to support the critical role ombudsmen play in
the care infrastructure, specifically the long-term care and community-
based care infrastructure funded in part by Medicaid and Medicare.
Two years ago, volunteers in Washington donated approximately
32,860 hours of their time and skill to resolve complaints made to the
program with a success rate of nearly 90 percent. We save the state
resources by resolving complaints at the lowest level keeping them out
of the expensive regulatory and legal systems. However, like our sister
programs across the nation, we are not able to keep up with consumer
needs and growing costs. One of the key areas of need right now is the
direct result of the covid-19 pandemic. The advocacy and protections
our programs provide are necessary to address the trauma and impact
that residents, family members, and staff have experienced during the
pandemic. Many ombudsman programs, due to the risks, have lost paid
staff and volunteers who need to be replaced.
The pandemic put all ombudsmen on high alert. The Washington State
LTCOP responded swiftly to the needs of residents and their families by
adapting our methods, and developing ways to reach into facilities that
were in ``lockdown''. We distributed nearly 70,000 post cards and notes
to long-term care residents and their families informing them about the
program, and Residents Rights. Through private donors and a grant from
Washington State, we delivered approximately 800 Amazon Fire Tablets to
adult family homes to help residents ``stay connected'' with their
family, friends, and communities. We advocated on behalf of residents
and their families through participation in multiple stakeholder
meetings, educating and informing journalists, providing testimony, and
working with our state legislature to pass meaningful legislation
(HB1218). The State LTCOP created a mental health and spiritual
counselor referral list to address the loss and grief, and the trauma
experienced by long-term care residents. We organized a new resident-
only advisory council to the State LTC Ombuds, giving voice to the
thousands of long-term care residents who were voiceless during the
pandemic. These are just a few examples of the work conducted during
the COVID-19 crisis which is not yet over.
To alleviate the effects of diminished budgets and expanding long-
term care populations, we respectfully request the following funding to
support all SLTCOPs.
First, we request $65,000,000 to support SLTCOP work with residents
of assisted living, board and care, and similar community-based long-
term care settings. While the mandate to serve residents in assisted
living facilities was added to our mission Act, there have been no
appropriations for this function. Assisted living and similar
businesses have boomed, but SLTCOP funding has not increased to meet
the demand and respond to the industry boom. We rarely are able to get
to the growing number of assisted living facilities, which depending on
the state are called board and care and other names. Nationally, for
example, while assisted living beds have grown to more than 57,000 in
the years 2013 to 2018, we have about 2,000 fewer volunteers and only
71 more paid ombudsmen over that five-year period.
Home and Community based service options continue to grow in
number, but there is no expansion in ombuds services. Increases in
long-term care residents is a key factor and challenge to providing our
cost saving advocacy services. Washington State has demonstrated
leadership by reducing Medicaid costs, while excelling in consumer
options outside of expensive nursing homes. Assisted living residents
have complex medical needs, very much like the nursing home residents
of 20 years ago. Growth in the number of assisted living facilities, in
conjunction with complex needs of consumers and diminished funding
threaten the health and wellbeing of people in our care. These
challenges hinder our ability to meet program requirements to provide
regular and timely access to all residents wanting long-term care
ombudsman services. Current funding levels preclude SLTCOPs from
quickly responding to complaints and monitoring facilities. Without our
eyes and ears in these buildings, residents are at risk of abuse,
neglect, and serious financial exploitation, and any number of
violations of their rights.
Our second request is for $70,000.000, which is needed to provide
core program funding for the program under Title VII of the Older
Americans Act. These funds must be allocated to all fifty states. In
addition to improving the quality of life and care for our family
members and neighbors in long-term care, our work saves Medicare and
Medicaid funds by avoiding costs associated with poor quality care,
unnecessary hospitalizations and expensive procedures and treatments.
Furthermore, nationally in 2019, more than 5,947 volunteers donated
their time. Ombudsman staff and volunteers investigated 198,502
complaints made by residents, relatives, friends, and volunteers.
Ombudsmen were able to resolve or partially resolve 71.5 percent--or an
ombudsman resolved nearly three out of every four complaints
investigated.
In 2018, Washington State had 3,818 long-term care facilities with
approximately 71,000 residents. Our state program includes me, and two
other full-time staff, which has not changed much since 1989.
Thankfully, we have great partnerships with other not-for-profits to
operate local ombudsman programs, extending our reach into the most
isolated of nursing home residents in our rural communities. These
partners include seven Area Agency on Aging entities and three
Community Action Programs and in total, we employ 17.51 full-time
staff. Two national studies about the effectiveness of the LTC
Ombudsman Program (the Institute of Medicine, and the Bader Report)
have recommended that best practice be to employ one full-time paid
ombudsman for every 2,000 long-term care residents or licensed beds.
Washington State falls short of that goal at having only 49 percent of
the needed paid staff.
Although we have a great team of paid and volunteer ombudsmen, our
program suffered a significant loss of volunteers during the pandemic.
We weren't able to cover every facility before the pandemic and things
are worse now. Nearly half of the facilities in our state never receive
routine visits by an ombuds, and visitations are the hallmark activity
of the Program--vital to building trust and effectiveness. We are so
busy responding to complaints that we are not able to conduct regular
outreach or build presence in all facilities. We are overwhelmed with
complaints about involuntary, and unlawful discharges, also known as,
``resident dumping'' which is harmful to residents, and costly. Long-
term care providers recognize the value and benefit of the LTC
Ombudsman program trainings, and consultation services, which often
address problems before they escalate.
Third, we request $20,000,000 to support the work of SLTCOPs under
the Elder Justice Act (EJC). This appropriation would allow states to
hire and train staff and recruit more volunteers to prevent abuse,
neglect, and exploitation of residents and investigate complaints.
However, the funds have been authorized since 2010, to date no EJC
funds have been appropriated for SLTCOPs, except for $4 million in the
Coronavirus Response and Relief Supplemental Appropriations Act of
2021. Currently, federal Older Americans Act funding comprises about a
third of the total funding required to maintain the Washington Long-
Term Care Ombudsman Program, at its current level, with the majority of
funding coming from our State General Funds.
Demand for our services is growing. The number of complex and very
troubling cases that ombudsmen investigate has been steadily
increasing. As more residents are vaccinated and facilities ``re-open''
ombudsmen are returning to in-person visits. What we see is concerning
and disturbing when it comes to poorer staffing levels and the impacts
of social isolation. In addition, there continues to be a disturbing
increase in the frequency and severity of citations for egregious
regulatory violations by long-term care providers that put residents in
immediate jeopardy of harm. Ombudsmen are needed now more than ever in
nursing homes, assisted living, and similar care facilities.
In order to improve advocacy and services available to residents,
our office and NASOP respectfully request the aforementioned funding
levels. Just think how much more we could accomplish if we had the
resources to meet the demand.
We appreciate that the Leadership Council of Aging Organizations
has written in support of these requests.
Thank you for your ongoing support.
[This statement was submitted by Patricia L. Hunter, MSW,
Washington State Long-Term Care Ombudsman.]
______
Prepared Statement of the National College Attainment Network
Dear Chair Murray and Ranking Member Blunt,
Thank you for your continued leadership in past funding cycles to
reinforce investments in the federal programs that support students in
their pursuit of higher education. Today, we write to respectfully
request that federal student aid funding be a high priority for the
Subcommittee. Without the statutory discretionary spending caps for
Fiscal Year 2022, we hope that total discretionary funding can rise to
provide strong support for our nation's higher education system and
students.
With this goal in mind for FY22, NCAN recommends these specific
funding levels for the U.S. Department of Education programs:
--NCAN recommends the requisite funding in FY22 so that the maximum
Pell Grant award can be increased to $12,990, double the
current maximum award.
--Supplementary Educational Opportunity Grant funding of $1.061
billion.
--Federal Work-Study funding of $1.48 billion.
--TRIO program funding of $1.316 billion.
--GEAR UP funding of $435 million.
--$200 million increase in administrative funding for federal student
aid management.
Additionally, we request that the Corporation for National and
Community Service receive $1.21 billion in funding for FY22--and that
the AmeriCorps program, that allows some college access programs to
provide near-peer mentors for their students, receive $501 million in
funding.
The National College Attainment Network (NCAN), founded in 1995,
represents more than 600 members across the country that all work
toward NCAN's mission to build, strengthen, and empower communities and
stakeholders to close equity gaps in postsecondary attainment for all
students. Collectively, we are committed to college access and success
so that all students, especially those underrepresented in
postsecondary education, can achieve their educational dreams. NCAN's
members span a broad range of the education, nonprofit, government, and
civic sectors, including national and community-based nonprofit
organizations, federally funded TRIO and GEAR UP programs, school
districts, colleges and universities, foundations, and corporations.
Drawing on the expertise of our hundreds of organizational members
in every U.S. state, NCAN is dedicated to improving the quality and
quantity of support that underrepresented students receive to apply to,
enter, and succeed in postsecondary education. Students of color,
students from low-income backgrounds, and those who are the first in
their family to attend college experience disproportionately lower
rates of postsecondary success. For example, a low-income student is
29% less likely to enroll in postsecondary education directly after
high school than a high-income student. Ultimately, only 35% of low-
income high school students obtain a postsecondary credential by age
26, compared to 72% of high-income students.
The federal investments that would most bolster the goal of closing
attainment gaps include the following:
pell grant investments
NCAN recommends that the maximum Pell Grant award be increased to
$12,990, double the current maximum award. The Pell Grant has served as
the cornerstone of financial aid for students from low-income
backgrounds pursuing higher education since its creation in 1972. This
need-based grant provides crucial support for around 7 million students
each year, or about one-third of undergraduates. Without this need-
based grant funding, an even smaller portion of students from low-
income backgrounds would be able to access higher education. Congress
has recognized the importance of the Pell Grant over the past five
years by investing in annual increases of, on average, about $140 to
the maximum award.
Given that the previously required automatic inflationary increases
have expired, these annual investments by Congress have been essential
for the nation's students who do not have the means to pay for college
from falling farther behind in their pursuit of higher education. Even
with these investments, the purchasing power of the Pell Grant for a
four-year college degree from a public institution is holding at a
historic low of 29% of the cost of attendance. At its peak in 1975-76,
the maximum Pell Grant award covered more than three-fourths of the
average cost of attendance--tuition, fees, and living expenses--for a
four-year public university.
To address the long-term purchasing power of the Pell Grant, and to
have the Pell Grant be increased so that it covers at least half of the
cost of a four-year public higher education, the maximum award should
be doubled.
In President Biden's budget for FY22, the administration has
requested that Congress consider a Pell Grant increase of $1,875,
through discretionary and mandatory funding, to bring the maximum award
to $8,370 for the 2022-23 award year. If Congress adopted the
President's request, raising the maximum Pell Grant to $8,370, its
purchasing power would significantly increase to 36%. NCAN applauds
this historic investment, referred to in the budget as a ``down payment
on the President's commitment to doubling the grant in future years.''
NCAN encourages Congress to consider a plan for future increases that
would achieve a doubling of the Pell Grant, such as is outlined in the
bicameral Pell Grant Preservation and Expansion Act of 2021--which
would achieve this goal, over a five-year timeframe.
To reach this goal, NCAN requests the requisite funding in FY22 so
that the maximum individual Pell Grant award can be increased to
$12,990, double the current maximum award.
fafsa simplification
In President Biden's budget for FY22, the administration requests a
$200 million increase in administrative funding for federal student aid
management. These funds are necessary to help with the implementation
of the FAFSA Simplification Act and FUTURE Act--two laws that will
achieve the goal of simplifying the Free Application for Federal
Student Aid (FAFSA) process, a top priority for NCAN. With the Office
of Federal Student Aid announcing a phased implementation plan for
FAFSA simplification, to take full effect one year later than
originally anticipated, NCAN supports this funding request to ensure
that the timeline is not further delayed. The urgency for students to
access need-based aid has only grown since passage of the legislation.
campus-based aid
As low-income students piece together resources from a variety of
sources to support their postsecondary education pursuits, every dollar
and type of aid is significant. For most low-income students, the
Supplemental Educational Opportunity Grant (SEOG) and Federal Work-
Study help to fill unmet need in their financial aid packages.
The SEOG program should be increased for FY22 so that institutions
of higher education to support a greater percentage of the country's
lowest-income students. For FY22, NCAN respectfully requests that
Congress fund the SEOG program at a total of $1.061 billion.
Sixty-four percent of today's students work while enrolled in
school. The Federal Work-Study (FWS) program allows students to work in
a flexible environment, learn important skills, and minimize the amount
of time they spend commuting between work and campus. For FY22, NCAN
respectfully requests that Congress increase the FWS program budget for
a total of $1.48 billion.
Federally Funded College Access Programs--TRIO and GEAR UP
Annually, approximately 1.8 million high school seniors are defined
as students from low-income backgrounds. A variety of programs are
needed to meet all their needs as they pursue their options for
education beyond high school. The NCAN community serves approximately 2
million students annually from middle school through college
graduation. To reach all the students needing services nationwide, our
members build important partnerships both with TRIO and GEAR UP
programs. NCAN respectfully requests that Congress continue its
investment in federally funded college access programs at the amounts
requested by their communities: $1.316 billion for TRIO and $435
million for GEAR UP.
corporation for national and community service (cncs)
For every dollar spent on national service, the country sees a
return on investment that is almost fourfold. Service also plays an
important role in the college access movement. Many of NCAN's largest
members can maximize their impact on underrepresented students by
participating in the AmeriCorps public-private partnership. Continuing
support for CNCS, and specifically the AmeriCorps program, will enable
additional volunteers to work with low-income students, students of
color, and students who are first in their family to attend college.
NCAN respectfully requests of that the Corporation for National and
Community Service and the AmeriCorps program receive $1.21 billion and
$501 million, respectively, for FY22.
Thank you for this opportunity to provide our funding priorities
for the fiscal year 2022. Through continued supports--both financial
and programmatic--our country can work together to close gaps in
attainment, where a low-income student is about half as likely to
complete a postsecondary degree or credential as a high-income student.
Thank you for your support of this important goal.
Sincerely.
[This statement was submitted by Kim Cook, Executive Director,
National College Attainment Network.]
______
Prepared Statement of the National Council for Diversity
in the Health Professions
Chairwoman Murray, Ranking Member Blunt, and distinguished members
of the subcommittee, thank you for the opportunity to submit this
statement for the record on behalf of the National Council for
Diversity in the Health Professions (NCDHP). I am Dr. Wanda Lipscomb
and I serve as President of the NCDHP and Director of the Center of
Excellence for Culture Diversity in Medical Education at Michigan State
University. NCDHP was established in 2006 and is composed of
institutions that are either currently or formerly distinguished as a
``Center of Excellence'' through the Health Resources and Services
Administration's (HRSA)'s Centers of Excellence (COE) program or are a
current or former recipient of the Health Careers Opportunities Program
(HCOP) grant, now known as the National HCOP Academies program. Every
member institution within the council is committed to advancing
pipeline programs and programmatic activity that leads to diversity in
the health professions.
The National Council for Diversity in Health Professions (NCDHP) is
comprised of institutions with Centers of Excellence (COE) and Health
Careers Opportunity Program (HCOP) grants funded by the Health
Resources and Services Administration under the Title VII Health
Professions Training Programs. COE/HCOP grantees are in health
professions education and other institutions which excel in the
development of educational pipeline programs for individuals from
minority and disadvantaged backgrounds, and in the improvement of the
quality of health care delivery to medically underserved communities. I
am proud to put forth the following recommendations for the fiscal year
(FY) 2022 appropriations process:
Minority health professional development is a cost-effective and
long-term mechanism of improving health care and decreasing health
disparities in minority and underserved communities. 50-80% of Under-
Represented Minority (URM) physicians and other health professionals
practice in shortage areas serving minority patients. Minority health
professionals possess the cultural, experiential and linguistic skills
needed to provide cost-effective health care to minority communities.
Minority students identified, recruited, supported, admitted, and
trained in the health professions in this decade will provide services
into the 2060s and 2070s.
hrsa centers of excellence (coe) recommendation
COE award recipients serve as innovative resource and education
centers to recruit, train, retain and graduate URM students and faculty
at health professions schools. Programs improve information resources,
clinical education, curricula, and cultural competence as they relate
to minority health issues and social determinants of health. These
award recipients also focus on facilitating faculty and student
research on health issues particularly affecting URM groups. The goal
of the program is to effectively deliver health care to underserved
communities.
NCDHP recommends $47.42 million for the COE program in Fiscal Year
2022
hrsa health career opportunities program (hcop) recommendation
HCOP provides opportunities for colleges and community-based health
professions training and promotes the recruitment of qualified students
and non-traditional students like veterans from disadvantaged
backgrounds into health and allied health professions programs. As a
major federal pipeline program into the health professions, HCOP
improves the acceptance, retention and matriculation rates of
participating students by implementing tailored enrichment programs
designed to address their academic and social needs.
The NCDHP recommends $47.95 million for the HCOP program in Fiscal
Year 2022.
funding justification and appropriations history for hrsa's hcop and
coe programs
--The Association of American Medical Colleges projects that in the
U.S. there will be a shortage of nearly 120,000 primary
care physicians by the year 2030. Looming workforce
shortages exist not only in medicine, but also in
dentistry, public health, physician assistants and other
health professions. If not adequately addressed, our nation
will continue to fall short in addressing the needs of
medically underserved communities as most recently exposed
by the COVID-19 pandemic.
--We are seeking to restore COE and HCOP funding to FY 2005 levels.
For FY 2006 the COE appropriation was cut by 65% from $33M
to only $12M. Similarly HCOP was cut by 89% to only $4M.
Adjusting for inflation COEs $33M in 2005 dollars would be
$45M in 2021 dollars. HCOPs $35M in 2005 would now be $47M.
--The number of COE grantees dropped from 34 (in 2005) to 19 (in
2020), and the number of HCOP grantees dropped from 74 (in
2005) to 22 (in 2020). These programs have not fully
recovered. Presently there is not enough funding in either
program to support a new competition-only to maintain
existing programs. A significant increase is needed in COE
and HCOP to increase the number of Latino, Black, American
Indian and disadvantaged students recruited, admitted and
graduated as culturally competent physicians and other
health professionals who have a high likelihood of
practicing in underserved minority communities. For
example, with increased funding, COE could launch an
initiative to increase the number of post-baccalaureate
slots and programs that enroll previously rejected
applicants in one-year programs, with 90% being accepted to
medical school, of which >95% will graduate as physicians.
As you begin the FY 2022 process, NCDHP asks that you further
prioritize Title VII health professions training programs. Chairwoman
DeLauro, Ranking Member Cole, please allow me to express my
appreciation to you and the members of this subcommittee. With your
continued help and support, NCDHP member institutions are keeping
course to overcome health workforce and health disparities. Thank you
for your time and consideration of these requests. We look forward to
working with the Subcommittee to prioritize the health professions
programs in FY 2022 and the future.
[This statement was submitted by Wanda Lipscomb, PH.D., President,
National Council for Diversity in the Health Professions.]
______
Prepared Statement of the National Eczema Association
summary of fiscal year 2022 appropriations recommendations
_______________________________________________________________________
--Please provide the National Institutes of Health (NIH) with at
least $46.1 billion to expand and advance critical research
activities, and provide individual NIH institutes and centers,
such as the National Institute of Allergy and Infectious
Diseases (NIAID) and the National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS) with proportional
funding increases.
--While NIH has received notable funding over recent years, funding
for the eczema portfolio has stayed relatively flat and
additional resources are needed.
--Please provide the Centers for Disease Control and Prevention (CDC)
with at least $10 billion to facilitate timely public health
efforts on a variety of conditions, including skin disease.
Additionally, please provide individual CDC centers, such as
the National Center for Chronic Disease Prevention and Health
Promotion (NCCDPHP) with proportional funding increases.
--Please provide $5 million for the new Chronic Disease Education
and Awareness Program at CDC.
_______________________________________________________________________
Thank you for the opportunity to submit testimony on behalf of the
National Eczema Association and the over 31 million eczema patients of
all ages across the country. Chairwoman Murray, Ranking Blunt, and
distinguished members of the subcommittee, thank you for the ongoing
investment in medical research that has facilitated breakthroughs and
scientific progress for the eczema community. As you and your
colleagues work on appropriations for FY 2022, please continue this
investment in medical research and similarly provide robust funding for
public health programs. Thank you for your time and for your
consideration of these requests.
about the national eczema association (nea)
NEA is the driving force for an eczema community fueled by
knowledge, strengthened through collective action and propelled by the
promise for a better future.
Reflecting back and looking ahead led us to appreciate how central
the concept of ``community'' has become to NEA's identity and its
existence, as is now captured in our aforementioned mission statement.
We also recognize that what we mean by the term ``eczema community''
has expanded over the years to reflect a multitude of personal and
professional interests committed to making life better for those who
live with eczema. Many people seek out NEA to connect with others who
understand and share the experience of living with eczema. Each
individual's unique perspective, based on their own experience, is a
source of strength and vibrancy for the diversity of our community.
Through our dedicated advocates, we will share some of those stories
and perspectives with you today.
about eczema
Eczema is the name for a group of conditions that cause the skin to
become itchy, inflamed and red in lighter skin tones or brown, purple,
gray or ashen in darker skin tones. Eczema is very common in both
children and adults and affects all races and ethnicities. In fact,
more than 31 million Americans have some form of eczema- with up to 40%
of affected individuals experiencing more severe disease symptoms and
chronic disease burden.
Eczema is not contagious. You cannot ``catch it'' from someone
else. While the exact cause of eczema is unknown, researchers do know
that people who develop eczema do so because of a combination of genes
and environmental triggers.
When an irritant or an allergen from outside or inside the body
``switches on'' the immune system, it produces inflammation. It is this
inflammation that causes the symptoms common to most types of eczema.
There are seven different types of eczema:
--Atopic dermatitis
--Contact dermatitis
--Neurodermatitis
--Dyshidrotic eczema
--Nummular eczema
--Seborrheic dermatitis
--Stasis dermatitis
It is possible to have more than one type of eczema on your body at
the same time. Each form of eczema has its own set of triggers and
treatment requirements, which is why it is so important to consult with
a healthcare provider who is knowledgeable in treating eczema. Many
healthcare providers can be involved in the diagnosis and treatment of
eczema including primary care providers, pediatricians, dermatologists,
and allergists. Recent years of scientific progress have led to the
emergence of new therapies, but much more work needs to be done in
research and public health to improve care for patients and address
areas of continued unmet treatment and quality of life needs.
recent advancements and emerging research opportunities
NEA's research priorities, including grants that we fund on an
annual basis, focus on improving health outcomes for the community and
translating breakthroughs in basic science to diagnostic tools,
innovative therapies, and improved healthcare information:
--Cutting-Edge Basic & Translational Science- Innovative
investigations of targets, pathways or technologies that will
advance understanding of the pathophysiology or natural history
of eczema, and potentially lead to novel or enhanced
therapeutic/preventative areas of exploration or application.
--Eczema Heterogeneity: Novel Insights- Projects aimed at advancing
understanding of the underlying factors contributing to the
diversity of eczema clinical presentation, treatment response
and comorbidities.
--Innovations in Clinical Practice & Care-Studies addressing
approaches to facilitate optimal identification and treatment
of eczema and associated comorbidities in all health care
settings to enhance patient-reported and patient-centric
outcomes.
--Understanding & Alleviating Disease Burden-Insightful proposals
that identify, quantify or aim to reduce aspects of eczema
burden that negatively affect patient or family/caregiver
quality of life (including lifestyle, academic/occupational, or
economic impacts) based on patient population, treatment
approach, etc.
--Eczema Prevention-Novel investigations into the potential risk
factors and strategies of primary eczema prevention at all
ages.
Our research efforts overlap with NIH-supported research
activities, which currently total a modest-but-meaningful $35 million
annually.
patient stories
People with eczema and their loved ones are the true experts, which
is why we call upon our community regularly to share their stories.
Lindsay is one of our Illinois advocates. She was diagnosed at six
years old with eczema. Now, in her 40s, she wants to ensure that
policymakers understand that eczema is more than just a rash. While
getting access to a biologic has been a challenge (to the point where
she had to miss doses), the medicine has changed the way eczema
presents on her skin. It still gets angry and red, but it no longer
weeps. It will just dry up and flake off. Her body is about 75% clear
on a good day, but she can still get bad flares primarily on her face
and neck.
Andrea is one of our Connecticut advocates. She has had eczema for
15 years and her youngest child was diagnosed with eczema on the back
of her knees two years ago. She advocates that all patients should have
access to specialty care because to help heal eczema you need the right
support and right care to know the underlying cause.
Traciee is one of our Oregon advocates. She advocates on behalf of
herself and all the eczema warriors and their families. She feels
strongly that patients should have access to quality healthcare and
that fellow eczema warriors should not have to suffer in silence with
an uncontrollable itch. The solution is that treatment decisions should
be made by the provider who has received extensive training in this
disease.
[This statement was submitted by Michele Guadalupe, MPH, Associate
Director, Advocacy and Access.]
______
Prepared Statement of the National Family Planning & Reproductive
Health Association
Dear Chairwoman Murray and Ranking Member Blunt:
As President & CEO of the National Family Planning & Reproductive
Health Association (NFPRHA), I thank you for this opportunity to
provide testimony in support of a fiscal year (FY) 2022 appropriation
of $737 million for the Title X family planning program (Office of
Population Affairs, funded within the Health Resources and Services
Administration account). We are grateful for Chairwoman Murray's
longtime leadership in advocating for family planning and urge you to
take this substantial step forward in this year's bill.
NFPRHA is a non-partisan, non-profit membership association whose
mission is to advance and elevate the importance of family planning in
the nation's health care system; NFPRHA membership includes close to
1,000 members that operate or fund more than 3,500 health centers that
deliver high-quality family planning education and preventive care to
millions of people every year in the United States. These members cover
the broad spectrum of publicly funded family planning providers,
including state and local health departments, hospitals, family
planning councils, federally qualified health centers, Planned
Parenthood affiliates, and other private non-profit agencies. NFPRHA
represents three-quarters of all current Title X grantees as well as
the majority of grantees that withdrew from the program in 2019 rather
than comply with the Trump administration's program rule.
Title X is the nation's only federal program dedicated to providing
family planning services for people with low incomes across the United
States. In 2018, prior to the implementation of the Trump
administration's devastating regulations, nearly 4,000 health centers
in the network served nearly 4 million patients.\1\ Title X-funded
health centers are lifelines for their communities, providing high-
quality reproductive and sexual health care, including cancer
screenings, testing and treatment for sexually transmitted infections,
HIV/AIDS education and testing, contraceptive services and supplies,
pregnancy testing, and other vital health care services. These centers
disproportionately serve people from communities that face systemic
barriers to accessing quality health care, including people with low
incomes, people who are uninsured or underinsured, people of color,
people who live and work in rural areas, LGBTQ people, and young
people. In fact, 60% of women who received contraceptive services from
a Title X-funded health center in 2016 had no other source of medical
care in the prior year,\2\ and almost two-thirds of patients at these
sites have incomes at or below the federal poverty level.\3\
---------------------------------------------------------------------------
\1\ Christina Fowler et al, ``Family Planning Annual Report: 2018
National Summary,'' RTI International (August 2019). https://
www.hhs.gov/opa/sites/default/files/title-x-fpar-2018-national-
summary.pdf.
\2\ Meghan Kavanaugh, ``Use of Health Insurance Among Clients
Seeking Contraceptive Services at Title X-Funded Facilities in 2016,''
Guttmacher Institute (June 2018). https://www.guttmacher.org/journals/
psrh/2018/06/use-health-insuranceamong-clients-seeking-contraceptive-
services-title-x.
\3\ Christina Fowler et al, ``Family Planning Annual Report: 2019
National Summary,'' RTI International (September 2020). https://
opa.hhs.gov/sites/default/files/2020-09/title-x-fpar-2019-national-
summary.pdf.
---------------------------------------------------------------------------
Unfortunately, the current funding level is woefully below what is
required to meet the family planning and sexual health needs of people
living with low incomes. Title X has been cut or flat-funded every year
for the past decade, and the program's FY2021 allocation is just $286.5
million, the same allocation the program has received for seven fiscal
years, and significantly below the allocation from a decade ago. Other
important public health programs, such as the Title V Maternal-Child
Health Block Grant and the Ryan White HIV/AIDS Program, have seen
significant increases in the same period, and people who rely on
publicly funded family planning care deserve that same investment in
their health care needs. The current allocation is also well below the
$737 million estimate that researchers from the Centers for Disease
Control and Prevention, the Office of Population Affairs (OPA), and the
George Washington University determined in 2016 would be needed
annually just to provide family planning care to low-income women
without insurance.\4\ We urge you to take a substantial step forward
for family planning access and appropriate that $737 million for the
program in FY2022.
---------------------------------------------------------------------------
\4\ Euna August, et al, ``Projecting the Unmet Need and Costs for
Contraception Services After the Affordable Care Act,'' American
Journal of Public Health (February 2016): 334-341.
---------------------------------------------------------------------------
This funding increase is particularly vital given the harms the
Trump administration inflicted on the program, the providers funded by
it, and, most importantly, the people who seek family planning and
sexual health care. On July 15, 2019, that administration's regulations
for Title X went into effect, and the impact was felt almost
immediately: by fall 2019, approximately 1,000 health centers across 33
states had withdrawn from the program. In 2018, those health centers
had provided 1.6 million patients with high-quality Title X-supported
family planning and sexual health services.\5\ In September 2020, OPA
released the first federal data showing the impact of the rule, and the
results were devastating: relative to 2018, Title X-funded health
centers provided family planning services to 844,083 fewer patients in
2019, a staggering 21% decrease, and that was after just five months of
having the rule in effect. In addition, fourteen states lost more than
one-third of their patient volume. This drastic decrease translated to
hundreds of thousands of fewer contraceptive services provided, more
than 1 million fewer STD tests administered, and more than 250,000
fewer life-saving breast and cervical cancer screenings performed with
Title X funds.\6\ The numbers for 2020--no doubt exacerbated by the
impact of COVID-19 on health care access--are even worse, with
preliminary data showing that only 1.5 million people were able to
receive Title X-supported services in 2020, a drop of 60% from just two
years earlier.\7\ Six states--Hawaii, Maine, Oregon, Utah, Vermont, and
the chairwoman's home state of Washington--have had no Title X-funded
services for almost two years.
---------------------------------------------------------------------------
\5\ Mia Zolna Sean Finn, and Jennifer Frost, ``Estimating the
impact of changes in the Title X network on patient capacity,''
Guttmacher Institute (February 2020). https://www.guttmacher.org/
article/2020/02/estimating-impact-changes-title-x-network-patient-
capacity.
\6\ Christina Fowler et al, ``Family Planning Annual Report: 2019
National Summary,'' RTI International (September 2020). https://
opa.hhs.gov/sites/default/files/2020-09/title-x-fpar-2019-national-
summary.pdf.
\7\ Ensuring Access to Equitable, Affordable, Client-Centered,
Quality Family Planning Services, 86 Federal Register 19812 (proposed
April 15, 2021) (to be codified at 42 CFR 59).
---------------------------------------------------------------------------
Compounding these harms, a 2020 study shows that COVID-19 has led
many women to want to delay or prevent pregnancy while it has
simultaneously made it more difficult for people to access family
planning and sexual health care, including contraception. Women of
color and women with low incomes are more likely to report both
findings.\8\ The confluence of the Trump administration's rule and a
global pandemic means that a significant influx of funds is desperately
needed to begin to rebuild the network and restore Title X services to
communities across the country as quickly as possible.
---------------------------------------------------------------------------
\8\ Lindberg LD et al, ``Early Impacts of the COVID-19 Pandemic:
Findings from the 2020 Guttmacher Survey of Reproductive Health
Experiences,'' Guttmacher Institute (June 2020). https://
www.guttmacher.org/report/early-impacts-covid-19-pandemic-findings-
2020-guttmacher-survey-reproductive-health.
---------------------------------------------------------------------------
These funds will be particularly significant given the Biden
administration's commitment to restore the Title X program's commitment
to high-quality, client-centered, evidence-based care by fall 2021.\9\
That process is moving quickly: on April 15, HHS published a notice of
proposed rulemaking, and comments were due on May 17.\10\ NFPRHA
continues to urge HHS to complete the rulemaking process as quickly as
possible and to subsequently make funds available to communities that
have been without services as soon as the new rule is in effect.
---------------------------------------------------------------------------
\9\ Office of Population Affairs, ``Title X Statutes, Regulations,
and Legislative Mandates,'' US Department of Health and Human Services
(March 2021). https://opa.hhs.gov/grant-programs/title-x-service-
grants/title-x-statutes-regulations-and-legislative-mandates.
\10\ Ensuring Access to Equitable, Affordable, Client-Centered,
Quality Family Planning Services, 86 Federal Register 19812 (proposed
April 15, 2021) (to be codified at 42 CFR 59).
---------------------------------------------------------------------------
We thank you for your consideration of this request.
Sincerely.
[This statement was submitted by Clare Coleman, President & CEO,
National Family Planning & Reproductive Health Association.]
______
Prepared Statement of the National Institutes of Health
Good morning, Chairwoman Murray, Ranking Member Blunt, and
distinguished Members of the Subcommittee. I am Francis S. Collins,
M.D., Ph.D., and I have served as the Director of the National
Institutes of Health (NIH) since 2009. It is an honor to appear before
you today.
First, I want to thank this Subcommittee for your commitment to
NIH, which allowed the biomedical research enterprise to respond
quickly to the greatest public health crisis in our generation over the
past year. We mounted vigorous research efforts to understand the viral
biology and pathogenesis of the coronavirus disease 2019 (COVID-19),
develop vaccines in record time, support and commercialize diagnostics
at the point of care, and test therapeutics for both outpatient and
inpatient settings. This work is far from finished.
The President's Discretionary Request proposes budget authority of
$51 billion for NIH in fiscal year (FY) 2022. The Biden Administration
places great emphasis on research and development in general. At NIH in
particular, the Request proposes to build on the successes of pandemic
era research and to put the research enterprise to work on some of our
Nation's most persistent and perplexing health challenges, including
cancer, Alzheimer's disease, opioid use disorder, health disparities,
maternal mortality, HIV/AIDS, gun violence, climate change, and other
areas with major implications for our Nation's health.
First and foremost, the President's Request proposes $6.5 billion
to establish the Advanced Research Projects Agency for Health--ARPA-H
to drive transformational innovation in health research and speed
application and implementation of health breakthroughs. ARPA-H will
tackle bold challenges requiring large scale, cross-sector
coordination, employing a non-traditional and nimble approach to high
risk research, modeled after DARPA in the Department of Defense. To
achieve this, ARPA-H will invest in emergent opportunities by
conducting advanced systematic horizon scans of academic and industry
efforts, leveraging novel public-private partnerships, recruiting
visionary program managers, and using directive approaches that provide
quick funding decisions to support projects that are results-driven and
time-limited. Potential areas of transformative research driven by
ARPA-H include: the use of the mRNA vaccines to teach the immune system
to recognize any of the 50 common genetic mutations that drive cancer;
development of a universal vaccine that protects against the 10 most
common infectious diseases in a single shot; development of wearable
sensors to measure blood pressure accurately 24/7; and leveraging of
artificial intelligence technology to advance care for individual
patients and improve detection of early predictors of disease.
ARPA-H represents the kind of transformative idea for biomedical
research that only comes along once in a long while. Our confidence
that NIH is ready has been greatly advanced by our experience in
addressing the COVID-19 pandemic--developing vaccines in record time,
establishing an unprecedented public-private partnership on
therapeutics that has made it possible to test more than a dozen
possible therapeutics in rigorous trials, and building a venture
capital model for assessing SARS-CoV-2 diagnostic technologies that has
yielded millions of daily tests in just months.
But while we begin to imagine a life after COVID-19, we must
acknowledge that there are COVID-related impacts that we have yet to
understand and address, including the full impact of the pandemic on
children. Children were largely spared from COVID-19 but for some
children, exposure to the COVID-19 virus led to Multisystem
Inflammatory Syndrome in Children (MIS-C), a severe and sometimes fatal
inflammation of organs and tissues. The Eunice Kennedy Shriver National
Institute of Child Health and Human Development (NICHD) is leading a
multi-institute initiative known as the Collaboration to Assess Risk
and Identify loNG-term outcomes for Children with COVID (CARING for
Children with COVID), which will assess both short-term and long-term
effects of MIS-C and other severe illness related to COVID-19 in
children, including cardiovascular and neurodevelopmental
complications.
For many Americans, this pandemic and its related socioeconomic
effects have had an overwhelming impact on their mental health. Prior
research on disasters and epidemics has shown that in the immediate
wake of a traumatic experience, large numbers of affected people report
distress, including new or worsening symptoms of depression, anxiety,
and insomnia. To aid in mental health recovery from the COVID-19
pandemic, NIH will continue to focus on research in this area. This
will be done, in part, by utilizing participants in existing cohort
studies, who will be surveyed on the effect of the pandemic and various
mitigation measures on their physical and mental health.
The COVID-19 pandemic has brought into sharp focus the dramatic
health disparities that exist across the American population. In
addition, the Nation has been shaken by the killing of George Floyd and
other attacks on people of color, forcing a recognition that our
country is still suffering the consequences of centuries of racism. NIH
will continue to address these disparities, specifically through
research managed by the National Institute on Minority Health and
Health Disparities (NIMHD), the National Heart, Lung, and Blood
Institute (NHLBI), the National Institute of Nursing Research (NINR)
and the Fogarty International Center (Fogarty).
NIMHD looks to better understand the human biological and
behavioral mechanisms and pathways that affect disparity populations,
better understand the long-term effects of disasters on health care
systems caring for populations with health disparities and research
focusing on the societal-level mechanisms and pathways that influence
disease risk, resilience, morbidity and mortality. NINR and Fogarty
both look to better understand and reduce rural health disparities in
low-income counties in the southern United States, support nursing
science focused on racial, ethnic, and socioeconomic health
disparities, with the goal of closing the gap in health inequities and
increase health disparity research in low and middle income countries.
In addition to the core health disparities research, the
President's Request puts an additional specific focus on maternal
morbidity and mortality (MMM), which disproportionately affect specific
racial and ethnic minority populations. Black and American Indian/
Alaska Native individuals are two to four times more likely to die from
pregnancy-related or pregnancy-associated causes compared to white
individuals. Furthermore, Black, Hispanic and Latina Americans, Asian,
Pacific Islander, and American Indian/Alaska Native individuals all
have higher incidence of severe maternal morbidity (SMM) compared to
white individuals. The Implementing a Maternal Health and Pregnancy
Outcomes Vision for Everyone (IMPROVE) initiative supports research on
how to mitigate preventable MMM, decrease SMM, and promote health
equity in maternal health in the United States.
As the climate continues to change, the risks to human health will
grow, exacerbating existing health threats and creating new public
health challenges. Major scientific assessments document a wide range
of human health outcomes associated with climate change. While all
Americans will be affected by climate change, underserved populations
are disproportionately vulnerable. These populations of concern include
children, the elderly, outdoor workers, and those living in
disadvantaged communities. NIH is poised to lead new research efforts
to investigate the impact of climate on human health, with the goal to
understand all aspects of health-related climate vulnerability.
Therefore, the President's Request includes a $100 million increase for
research on the human health impacts of climate change.
The FY 2022 President's Discretionary Request makes a major
additional investment to address the opioid crisis. The crisis of
opioid misuse, addiction, and overdose in the United States is a
rapidly evolving and urgent public health emergency that has been
exacerbated by the coronavirus pandemic. Since the declaration of a
public health emergency for COVID, illicit fentanyl use and heroin use
have increased, and overdoses in May 2020 were 42 percent higher than
in May 2019.
The use of opioids together with stimulants, such as
methamphetamine, is increasing; and deaths attributed to using these
combinations are likewise increasing. Taking note of these trends, FY
2021 appropriation language expanded allowable use of Helping to End
Addiction Long-term (HEAL) funds to include research related to
stimulant misuse and addiction. Identifying how opioids and stimulants
interact in combination to produce increased toxicity will enhance our
ability to develop medications to prevent and treat comorbid opioid and
stimulant use disorders and overdoses associated with this combination
of drugs.
Finally, I'd like to take a moment to thank this Subcommittee for
its recognition over the last two years that America's continuing
leadership in biomedical research requires infrastructure and
facilities that are conducive to cutting-edge research. With your
support, we will break ground in the near future on a new Surgical,
Radiological, and Laboratory Medicine division of our Clinical Center,
which will replace severely outdated and deteriorating operating suites
and lab space with state-of-the-art facilities. NIH continuously works
to ensure that the buildings and infrastructure on its campuses are
safe and reliable and that these real property assets evolve in support
of science--but NIH's backlog of maintenance and repair is now nearly
$2.5 billion. The President's FY 2022 Discretionary Request includes
$250 million to make progress on reducing this backlog and requests
flexibility for Institutes and Centers to fund construction, repair,
and improvement projects.
COVID-19 compelled us to perform a stress test on biomedical
research enterprise. The enterprise performed nobly. We found what
worked, and also identified barriers we hadn't fully appreciated
before, and invented new ways around them. The President's FY 2022
Discretionary Request is a roadmap for how to build on the successes of
research, address our gaps, and apply our insights to the most
important problems we face as a nation. With your support, the future
is filled with opportunity. My colleagues and I look forward to
answering your questions.
[This statement was submitted by Francis S. Collins, M.D., Ph.D.,
Director,
National Institutes of Health.]
______
Prepared Statement of the National Kidney Foundation
The National Kidney Foundation (NKF) is pleased to submit testimony
to highlight the significant burden that chronic kidney disease (CKD),
including irreversible kidney failure, places on patients, families,
and our nation's health care system. We urge the subcommittee to
increase funding for programs and activities as a bold step to help
transform CKD awareness, prevention, detection, and management.
Specifically, NKF requests $15 million for CKD activities at the
Centers for Disease Control and Prevention and a substantive increase,
commensurate with or exceeding the increase for NIH as a whole, for the
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) for kidney research activities. We also urge greater
collaboration between NIDDK and other Institutes studying related
comorbidities and conditions, such as hypertension, cardiovascular
disease, immunology, disparities, and genomics.
about ckd
CKD impacts an estimated 37 million American adults and was the
nation's 8th leading cause of death in 2020. Although it can be
detected through simple blood and urine tests, an estimated 90% of CKD
patients are undiagnosed, often until advanced stages when it is too
late for interventions to slow disease progression. Alarmingly, some
patients are not diagnosed until they have progressed to irreversible
kidney failure (end stage kidney failure, or ESKD) and undergo urgent
start dialysis. More than 750,000 Americans have irreversible kidney
failure, requiring kidney dialysis at least 3 times per week at a
dialysis center; daily home dialysis, or a kidney transplant to
survive. Medicare spends $130 billion on the care of people with a CKD
diagnosis. Individuals with kidney failure represent 1% of Medicare
beneficiaries but comprise 7% of Medicare fee-for-service expenditures.
The need for a substantially increased federal commitment to address
the societal and economic burdens of CKD is undeniable.
CKD is a disease multiplier, with many patients experiencing
cardiovascular disease, bone disease, cognitive challenges, depression,
and increased hospitalization. CKD also is an independent risk
predictor for heart attack and stroke. Early-stage intervention can
improve outcomes and lower costs, yet fewer than half of patients with
high blood pressure or diabetes (which together are responsible for
three-fourths of all cases of ESKD) receive CKD testing. To improve
awareness, early identification, and early-stage intervention, NKF
calls on Congress to invest in kidney health programs throughout HHS.
disparities
CKD is characterized by racial, ethnic, and socioeconomic
disparities. Blacks or African Americans, Hispanics, Asian Americans
and Pacific Islanders, and Native Americans or Alaska Natives are at
higher risk for CKD and ESKD. A common reason is the disproportionate
incidence of chronic comorbidities such as diabetes and hypertension in
many of these groups. While Blacks or African Americans make up 13
percent of the U.S. population, they account for 35 percent of
Americans with kidney failure, and are almost four times more likely
than Whites to progress to kidney failure. Hispanic Americans are 1.3
times more likely than Whites to have kidney failure. Blacks or African
Americans and Hispanics experience more rapid decline of kidney
function than Whites and are less likely to have had a visit with a
nephrologist prior to starting dialysis. Disparities are present in
kidney transplant as well. Blacks have less access to the kidney wait
list and experience a longer wait once listed. As of May 6, 2021, Black
patients were 31.5% of the kidney wait list candidates, but in 2020
they received only 27% of kidney transplants. Hispanics represent 21%
of the wait list and received 18.4% of kidney transplants.
covid-19
COVID-19 has amplified the CKD and ESKD disparities discussed
above, as kidney patients (including transplant recipients) are at risk
for severe COVID-19 infection and mortality. In October 2020, COVID-19
hospitalizations were 2,194 per 100,000 Medicare ESKD beneficiaries,
compared to 320 per 100,000 Medicare aged beneficiaries. In data
reported by CDC, from February 1-August 31, 2020, a comparison of
observed and predicted monthly deaths among ESKD patients showed an
estimated 8.7-12.9 excess deaths per 1,000 ESKD patients, or a total of
6,953-10,316 excess deaths. The increased vulnerability is due to a
series of factors, including compromised immune systems, multiple
comorbidities, and exposure through the in-center dialysis care
environment that necessitates close contact with others. Transplant
recipients in particular face higher COVID-19 mortality risk. In
addition, patients experiencing severe COVID-19 are at an increased
risk of developing acute kidney injury (AKI), often requiring the need
for acute dialysis and sometimes resulting in CKD or irreversible
kidney failure.
kidney public awareness initiative
A key aspect of the Department of Health and Human Services's 2019
Advancing American Kidney Health (AAKH) Initiative is increased
awareness of CKD among the public and health care practitioners to
improve early detection, provide early intervention and improve
outcomes. Early intervention can slow the CKD progression and, in some
instances, prevent kidney failure, reduce the impact of comorbidities,
and reduce hospitalizations and readmissions. A sustained Kidney Public
Awareness Initiative under the guidance of CDC will educate at-risk
individuals to enhance awareness of the causes, consequences, and
comorbidities of kidney disease, and educate clinical professionals on
early detection and opportunities for intervention.
cdc chronic kidney disease initiative
The CDC Chronic Kidney Disease Initiative comprehensive public
health strategy was created at the urging of Congress and NKF 15 years
ago. Annual funding has fluctuated between $1.6 million and $2.6
million. This funding level has supported activities including the
development of a web site for patients, surveillance and epidemiology
activities, and assistance to the National Center for Health Statistics
for CKD data collection. However, a more robust effort is needed to
increase awareness and reduce incidence of CKD. The National Kidney
Foundation requests additional funds to establish a CKD screening
program to detect people at high risk and examine the benefits
screening this population; determine changes in provider behavior and
care, and monitor patients' health outcomes. Additional funding would
also expand capacity for national CKD prevalence surveillance to allow
for repeated laboratory measures in the National Health and Nutrition
Examination Survey (NHANES). Current national estimates of CKD
prevalence using NHANES rely on single measurements of both serum
creatinine and urinary albumin, preventing researchers from estimating
CKD persistence. NKF requests $15 million to the CDC for these enhanced
activities.
nih niddk
Despite the high prevalence of CKD and its impact on patients and
Medicare, NIH funding for kidney disease research is only about $700
million annually. NIH invests only $18 per CKD patient, a fraction of
what it spends on other major diseases. Fiscal Year 2021 funding for
NIDDK increased by less than 1%, the smallest percentage increase of
any disease Institute under NIH. From FY 2015-2020, NIH monetary
support for kidney research increased at half the rate of NIH funding
increases overall. America's scientists are at the cusp of many
potential breakthroughs in improving our understanding of CKD,
including genetic kidney disease. Further advances can lead to new
therapies to delay and treat kidney diseases, which has the potential
to provide cost savings to the government like that of no other chronic
disease.
In December 2020, NKF established Research Roundtables comprised of
nephrology leaders from prominent academic institutions, the
pharmaceutical industry, and key bodies with expertise in the multiple
areas of pre-clinical and clinical research, including pediatric
nephrology, genetics, epidemiology, drug development, public health,
and health equity. In addition, kidney disease patients as well as
family members of children with kidney disease and living kidney donors
were recruited to share patient priorities and viewpoints on research
needs.
The Roundtables were charged with identifying pre-clinical and
clinical areas of research in which additional funding could help
bridge existing deficits in kidney disease treatments and reduce kidney
disease incidence, reduce health disparities, and lower healthcare
costs. Their final recommendations are expected in June 2021, which NKF
will share with policy makers.
As the first step towards expanding kidney research opportunities,
NKF requests a substantive funding increase for NIDDK in FY 2022 that
is at least commensurate with if not exceeding the percentage increase
to NIH as a whole. We also request additional support from other
Institutes on kidney activities. Opportunities include NHLBI support
for cardiorenal syndromes in CKD patients; NIAID initiatives to study
CKD effects on the immune system; and NCI activities to study decreased
kidney function in cancer patients. Thank you for your consideration of
the National Kidney Foundation's requests for Fiscal Year 2022.
[This statement was submitted by Sharon Pearce, Senior Vice
President,
Government Relations.]
______
Prepared Statement of the National Marrow Donor Program/Be The Match
Chairwoman Murray, Ranking Member Blunt, and members of the
Subcommittee, my name is Kristin Akin from Chesterfield, Missouri. On
behalf of the patients, family members, donors, couriers, volunteers,
and staff of the National Marrow Donor Program (NMDP)/Be The Match, I
want to express my most sincere gratitude to the members of the
Committee for your work last year, continuing the full funding of the
C.W. Bill Young Cell Transplantation Program (Program) within the
Health Resources and Services Administration (HRSA), Health Care
Systems account. In Fiscal Year 2022, we respectfully request that the
subcommittee increase funding for the Program to the amount of
$56,000,000 to eliminate financial and socioeconomic barriers that
reduce access to cellular therapies for thousands of primarily
traditionally underserved patients.
By establishing a national bone marrow donor registry in the mid-
1980s, Congress promised patients with blood cancers, like leukemia and
lymphoma, that they would have a way to find a life-saving donor match.
While bone marrow transplant started as a cure for a single disease, we
now provide cures for over 70 diseases, everything from cancers, blood
disorders, immune deficiencies and Sickle Cell. In 2019, the Program
completed its milestone 100,000th transplant between a matched,
unrelated donor and a patient. This has been a true public/private
partnership for more than 30 years and it is obvious that the funding
is saving lives.
My son, Andrew Preston Akin, was born on June 5, 2007. At ten weeks
old, what initially started as severe jaundice quickly landed us in the
Pediatric Intensive Care Unit (PICU) at our local hospital. After
months of tests, on September 7, 2007, our world was officially turned
upside down when we were informed that Andrew had a rare immune
deficiency called Hemophagocytic Lymphohistiocytosis (HLH), and the
only cure was a bone marrow transplant.
Our then six-month-old son underwent his first bone marrow
transplant in an effort to save his life. He was started on the
standard protocol for HLH (HLH 2004) and initially responded very
positively. But, suddenly, his HLH came roaring back and not only did
we have to move up his transplant, we used umbilical cord cells, as
there was not a suitable bone marrow match on the registry at the time.
Grateful and optimistic that this was the end of HLH and the beginning
of a new and healthy Andrew, we were devastated to learn that two
months after his transplant, it did not work, and he would need another
one.
In the meantime, we continued with steroids, chemotherapy and a
host of other drugs, all the while keeping him in a bubble away from
any germs. The search began again to find Andrew the best possible
unrelated, matched bone marrow donor. Excited that marrow was going to
be the answer to our prayer, Andrew underwent his second bone marrow
transplant right before his first birthday. Sadly, almost a year to the
day of his diagnosis, we learned that again, for various reasons, his
transplant was not a success.
Through this process, we learned several things about Andrew's
disease: the cause of his HLH was among the newest genetic mutations--
X-Linked Lymphoproliferative Disorder #2 (XLP-2). Because it is X-
linked, the doctors immediately tested me and our other son Matthew. On
my 34th birthday, I received among the worst news in my life: not only
was I the carrier, but my healthy 4-year old son also carried the
mutation, meaning it was only a matter of time before he, too, would
get HLH.
After countless discussions with the team of experts, we weighed
the pros and cons of taking Matthew into transplant while he was
healthy or waiting until the disease struck.
We did another preliminary search on the bone marrow registry and
found one perfect match. Not knowing if that match would be there down
the road, we made the extremely difficult decision to transplant
Matthew prophylactically.
At the same time, we prepared Andrew for his third bone marrow
transplant in less than two years.
We were fighting for the lives of our two sons.
Andrew, only 27 months old, developed severe pulmonary
complications that ultimately took his life on September 5, 2009, in
the PICU.
Matthew was just two weeks post-transplant, we thought life could
not get any worse, but somehow, eight short months later, it did. Our
first-born son, Matthew Austin Akin passed away in the same PICU on May
1, 2010. He was only 5 and a half years old.
My husband and I have experienced every parent's worst nightmare,
twice, but we both agreed we would not allow our son's deaths to be the
last thing people remembered about them. It's why my husband and I
started the Matthew and Andrew Akin Foundation in their memory: to
raise awareness and critical funds for HLH, NMDP, and the American Red
Cross, and to advocate for other parents and children.
However, I would be remiss if I did not share that a very large
part of what drives us to continue to help others is the fact that we
were blessed with the opportunity to be parents again, twice, through
adoption. William and Christopher are the reason we have love in our
hearts and can fight for the memory of their brothers Matthew and
Andrew.
While Matthew and Andrew ultimately lost their lives due to disease
complications, NMDP was our line of hope that we held onto from day one
when learned that a successful bone marrow transplant was the only
cure. With each transplant my boys received, we were reminded of the
kindness of strangers, the feeling of indebtedness to NMDP and Congress
for establishing the registry and the power of a worldwide network. It
has been and will continue to be my honor to volunteer my time with
NMDP.
The C.W. Bill Young Cell Transplantation Program, authorized by
Congress, has been funded by the Committee and fulfills three important
missions. The first is the nation's registry, which includes more than
39 million selfless volunteers worldwide, like my sons' donors, who
stand ready to be a life-saving bone marrow donor. It also includes
more than 806,000 cord blood units through Be The Match and
international partnerships, 106,000 of which are in the National Cord
Blood Inventory, which is also funded by your Committee. When we
couldn't find a matching donor for Andrew right away, a cord blood
transplant was our only hope for his first transplant.
While Matthew and Andrew were able to proceed to transplant thanks
to their selfless matching donors, there are still many patients who
cannot find a match on the registry. This is why the funding you
provided in Fiscal Year 2021, and which we are asking for in Fiscal
Year 2022, is so critically important. From the moment doctors search
the registry for a donor, to the safe delivery of the life-saving cells
to the bedsides of patients for transplant--NMDP is there every step of
the way. NMDP ensures that the global network, technology, and
logistical support are in place to facilitate a transplant.
The Program's second mission is to support patients and families
through its Office of Patient Advocacy. NMDP works tirelessly to
improve the lives of patients and provide one-on-one support to these
individuals and their families. They offer the resources and guidance
patients need throughout the transplant process--from deciding if
transplant is right for them to adjust to life after transplant.
Finally, the Stem Cell Therapeutic Outcomes Database is a third
program component that helps doctors significantly impact/improve
survival for blood cancer and other diseases while also improving the
quality of life for thousands of transplant patients. NMDP is
relentless in its search to find answers that will lead to better donor
matching, more timely transplants, and treatment of even more blood
diseases through transplant.
Thank you for the opportunity to share my story and most
importantly thank you for learning a little bit about my beautiful sons
Matthew and Andrew. Your longstanding support for this Program is the
hope that people hold onto after receiving their life-threatening
diagnosis. On behalf of those who are alive today, those who are
currently searching the national registry for their potentially life-
saving donor, and for those who will need to look to the Program for
help in the future, I urge you to fund the C.W. Bill Young Cell
Transplantation Program at $56 million to immediately provide access to
therapy at the point of diagnosis for all patients.
Our bold request this year builds upon the full funding you
provided in Fiscal Year 2021 to clear a pathway for more patients,
especially those from minority and rural communities, to be able to
access transplant services. More than any other Committee in Congress,
the programs you support save lives every day. The increase we are
asking for this year will immediately increase the number of patients
who enter the pipeline to receive a bone marrow transplant for a
lifesaving cure.
[This statement was submitted by Kristin Akin on behalf of National
Marrow Donor Program/Be The Match.]
______
Prepared Statement of the National Multiple Sclerosis Society
Madam Chairwoman and Members of the Subcommittee, the National
Multiple Sclerosis Society (Society) thanks you for this opportunity to
provide testimony regarding fiscal year 2022 (FY22) funding for the
federal agencies under the jurisdiction of the Labor, Health and Human
Services, Education and Related Agencies (LHHS) subcommittee. Nearly
one million people who live with multiple sclerosis (MS) rely on these
agencies and as the U.S. recovers from the COVID-19 pandemic, the
federal agencies and programs under the jurisdiction of this Committee
are more important than ever.
The Society is supportive of the President's FY22 proposed budget
request. We believe this request would support the ability of people
with MS to receive the coverage and services they need and fund
critical research toward a cure for MS. We urge the Subcommittee to
provide the following funding in Fiscal Year 2022 (FY22):
--$500 million for the Agency for Healthcare Research and Quality
(AHRQ)
--$10 billion for the Centers for Disease Control and Prevention
(CDC) inclusive of $5 million for the National Neurological
Conditions Surveillance Program authorized in the 21st Century
Cures Act;
--$14.2 million for the Lifespan Respite Care Program;
--Robust support for Medicare and Medicaid and protection of
Medicaid's current financing structure; and
--At least $46.1 billion for the National Institute of Health (NIH),
--Fully fund the Patient Centered Outcomes Research Institute
(PCORI); and
--At least $13.5 billion for the Social Security Administration's
administrative budget.
MS is an unpredictable, often disabling disease of the central
nervous system that interrupts the flow of information within the
brain, and between the brain and body. Symptoms range from numbness and
tingling to blindness and paralysis. The progress, severity, and
specific symptoms of MS in any one person cannot yet be predicted. The
Society is a fundamental partner to the federal agencies under the LHHS
jurisdiction, and is focused on curing MS while ensuring that people
affected by the disease have what they need to live their best lives.
agency for healthcare research and quality
AHRQ is a small agency that is revolutionizing the healthcare
system based on health care costs and quality. It provides evidence-
based reports for health care providers to use in making health care
safer, higher quality, more accessible, equitable, and affordable.
These reports are vital to patients and the health care community,
which needs high-quality science and evidence-based
information to aid in consultations on treatment decisions. The
Society recommends Congress provide $500 million for AHRQ in FY22.
centers for disease control and prevention
CDC is tasked with protecting public health and safety through the
control and prevention of disease, injury, and disability. COVID-19
demonstrated how years of consistent underfunding impacted the Agency's
ability to fulfill its mission. Part of that mission that is often
overlooked involves data collection for diseases and conditions. The
21st Century Cures Act authorized the creation of the National
Neurological Conditions Surveillance System (NNCSS) at CDC, and
Congress has funded it since 2018. Although COVID-19 has delayed its
efforts, CDC has set up pilot projects in MS and Parkinson's disease to
determine the best method to collected incidence and prevalence data.
These methods would then be expanded to use in other neurologic areas.
Having strong and reliable prevalence data is critical to protecting
the public health and funding new and novel research to treat
neurologic conditions. The Society recommends that Congress increase
funding for the CDC to $10 billion in FY22, inclusive of the $5 million
for the NNCSS.
centers for medicare & medicaid services
Approximately 25-30 percent of the MS population relies on Medicare
as their primary insurer. Many of these individuals are under the age
of 65 and are eligible for Medicare due to disability. The Society
urges Congress to ensure appropriate reimbursement levels for Medicare
providers. These reimbursement levels allow Medicare beneficiaries to
maintain affordable access to prescription drugs, diagnostics, durable
medical equipment, medically necessary speech, physical and
occupational therapy services, and allows the program to update
coverage determinations to keep pace with advances in care.
Up to 15 percent of people with MS are thought to qualify for
Medicaid benefits for all or part of their health and/or long-term care
needs. The Society urges Congress to ensure robust funding for Medicaid
that allows for its enrollees to access benefits that are affordable
and adequate to their needs. Additionally, we advise Congress to oppose
proposals to cap or block grant the program or that impose unreasonable
utilization review practices that can result in disruptions in MS care,
putting patients at risk of disease exacerbations and irreversible
disability. Ensuing that lower income individuals have access to health
coverage and care is vital to the continued health and economic
recovery of the country and we oppose any policy shift that would limit
or cut services for people with MS.
lifespan respite care program
The Lifespan Respite Care Program provides competitive grants to
states to establish or enhance statewide lifespan respite programs that
better coordinate and increase access to quality respite care.
Approximately one quarter of individuals living with MS require long-
term care services at some point during their lifetime. Often, a family
member steps into the role of primary caregiver. Family caregivers
allow the person living with MS to remain home for as long as possible
and avoid premature admission to costlier institutional facilities but
can also become overwhelming. Respite offers professional short-term
help to give caregivers a break from the stress of providing care and
has been shown to provide family caregivers the relief necessary to
maintain their own health and bolster family stability. Many existing
respite care programs have age eligibility requirements, but the
Lifespan Respite Care Program serves families regardless of special
need or age. MS is typically diagnosed between the ages of 20 and 50,
and Lifespan Respite programs are often the only open door to needed
respite services. For these reasons, the Society asks that Congress
provide $14.2 million for the Lifespan Respite Care Program in FY22.
national institutes of health
The importance of the NIH cannot be overstated. It is the nation's
premiere biomedical research institution and drives innovation while
supporting jobs in all 50 states. The NIH is a fundamental partner in
the Society's mission to cure MS while empowering people affected by
the disease to live their best lives. To date, the Society has invested
over $1 billion in MS research; but we rely on Congress to provide
consistent and sustained investments to the NIH to cultivate an
environment that is optimal for scientific discovery and innovation. As
evident by the NIH funding that paved the way to the development of the
mRNA COVID-19 vaccines, NIH continues to provide the basic research
necessary to facilitate the development of novel therapies. In fact,
the NIH has provided the basic research that has led to every MS
treatment that is available today. The Society urges Congress to
provide at least $46.1 billion for the NIH in FY22. This funding level
would allow for meaningful growth of 5% in the NIH base budget, and we
urge the Agency to continue its efforts to diversify its workforce and
grantees and to support the careers of early-career investigators.
patient-centered outcomes research institute
PCORI serves a vital role in ensuring that the public and private
health care sectors have valid and trustworthy data on health outcomes,
clinical effectiveness, and appropriateness of different medical
treatments by both conducting research and evaluating existing studies.
Its research addresses the need for real-world evidence and patient-
focused outcomes data that will improve healthcare quality and help
shift healthcare payment models toward value-based care. To date, PCORI
has invested over $69 million in comparative effectiveness studies in
MS. These studies will provide important evidence for the best ways to
address questions surrounding what care approaches work best for whom
in various care settings and can inform conversations about value that
truly considers the patient perspective. This information is important
to aid in shared decision-making conversations between people with MS
and their healthcare providers in consultations on treatment decisions.
To complete this important work, we urge Congress to fully fund PCORI
in FY22.
social security administration (ssa)
Due to the unpredictable nature and sometimes disabling impairments
caused by the disease, SSA recognizes MS as a chronic illness or
``impairment'' that can cause disability severe enough to prevent an
individual from working. During such periods, people living with MS are
entitled to and rely on Social Security Disability Insurance (SSDI) or
Supplemental Security Income (SSI) benefits to survive. The National MS
Society urges Congress to provide robust funding of at least $13.5
billion for the Social Security Administration's administrative budget
in FY22.
The Society thanks the Committee for the opportunity to provide
written testimony on our recommendations for the base funding for
federal agencies programs under the jurisdiction of the FY22 LHHS
appropriations bill. The above agencies are of vital importance to
people affected by MS and all Americans. Please do not hesitate to
contact the Society with any questions that you may have, and we look
forward to continuing to work with the Committee to help move us closer
to a world free of MS.
[This statement was submitted by Leslie Ritter, Associate Vice
President, Federal Government Relations, National Multiple Sclerosis
Society.]
______
Prepared Statement of the National Pancreas Foundation
summary of fiscal year 2022 appropriations recommendations
_______________________________________________________________________
--The Foundation joins the broader research community in requesting
$46.1 billion in discretionary funding for the National
Institutes of Health (NIH), an increase of $3.2 billion over FY
2021. Further, please provide proportional increases for the
National Cancer Institute (NCI), the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK), and other
NIH Institutes and Centers.
--Please support adequate funding to establish the new Advanced
Research Projects Agency for Health (ARPA-H) at NIH as
proposed in the Administration's Budget Request to Congress
to facilitate robust and tangible scientific progress on a
variety of conditions, particularly cancers.
--The Foundation joins the broader public health community in
requesting $10 billion in overall funding for the Centers for
Disease Control and Prevention (CDC) to reinvigorate meaningful
professional education, public awareness, and public health
activities.
--Please provide the new CDC Chronic Disease Education and
Awareness Program with $5 million, an increase of $3.5
million over FY 2021, to further advance and expand timely
public health efforts with community stakeholders.
_______________________________________________________________________
Chairwoman Murray, Ranking Member Blunt, and distinguished Members
of the Subcommittee, thank you for the opportunity to submit testimony
on behalf of the National Pancreas Foundation (NPF) and the patient
community that we serve. We deeply appreciate the investments in the
National Institutes of Health (NIH) that have occurred over the past
five fiscal years and the research advancements that additional
resources have facilitated, most notably in potential treatments for
pancreatitis. Moreover, we thank you for establishing the new Chronic
Disease Education & Awareness Program at CDC with an initial investment
of $1.5 million in FY 2021. The COVID-19 pandemic has highlighted the
importance of robust investment in public health and with an infusion
of much-needed resources for CDC for FY 2022, please also enhance this
important new initiative. Thank you again.
about the foundation
The National Pancreas Foundation is a patient-driven, non-profit
organization that provides hope for those suffering from pancreatitis
and pancreatic cancer by funding cutting edge research, advocating for
new and better therapies, and providing support and education for
patients, caregivers, and health care professionals.
conditions of the pancreas
Pancreatitis can be acute or chronic. It is characterized by
inflammation of the pancreas, and chronic pancreatitis does not heal or
improve-it gets worse over time and leads to permanent damage. Chronic
pancreatitis eventually impairs a patient's ability to digest food and
make pancreatic hormones. Chronic pancreatitis can strike at any age,
but often develops in patients between the ages of 30 and 40, and is
more common in men than women. The annual incidence rate is 5-12 per
100,000 and the prevalence is 50 per 100,000. Pancreatitis can be
managed with proper information and healthy practices.
Pancreatic cancer is currently the third leading cause of cancer
deaths in the United States. One of the major challenges associated
with pancreatic cancer is that the condition often goes undetected for
a long period of time because signs and symptoms seldom occur until
advanced stages. By the time symptoms occur, cancer cells are likely to
have spread (metastasized) to other parts of the body, often preventing
surgical removal of tumors. Research indicates an emerging link between
pancreatitis and the onset of pancreatic cancer.
nih research: progress and opportunities
NIDDK has been a leader on pancreatitis research while NCI has
facilitated key breakthroughs for pancreatic cancer. More work needs to
be done though as translation and clinical research are necessary to
ensure innovative treatment options and diagnostic tools can be
deployed to the benefit of affected patients.
In this regard, NIDDK recently hosted an effort with the community
to capitalize on progress for pancreatitis and ensure promising ideas
move into the FDA pipeline for review. The need remains great as
pancreatitis patients currently have extremely limited treatment
options despite the severity of the illness. The advancements in the
pancreatitis research portfolio have now led to treatment review
activities at FDA and a critical Patient-Focused Drug Development
Initiative meeting with the community.
Moreover, the Cancer Moonshot has been extremely meaningful for
scientific efforts focused on pancreatic cancer. Similar to
pancreatitis though, treatment options remain extremely limited despite
the severity of the disease. In fact, due to improvements in other
areas and an overall lack of progress in outcomes, pancreatic cancer is
now the third leading cause of cancer deaths in America. While the
details in the budget request remain sparse our hope is the new ARPA-H
initiative will greatly enhance cancer research activities at NIH.
Over recent years, key Committee Recommendations have been included
that have moved the pancreas and pancreatitis research portfolios
forward, and it is our hope that the Subcommittee will continue to
demonstrate an interest in this area during the FY 2022 process.
cdc chronic disease education & awareness program
Thank you again for establishing the CDC Chronic Disease Education
& Awareness Program in FY 2021 and providing an initial investment of
$1.5 million. For many years, CDC has lacked public health initiatives
in a variety of conditions where simple interventions can save lives
and lower healthcare costs. Conditions of the pancreas are no exception
and access to simple health information can prevent the progress of
many conditions and in some cases lower the rate of pancreatic cancer.
Many patient organizations are seeking timely collaborations with CDC
that can directly impact patients and improve public health using this
new mechanism. It is important that this emerging program receives
annual funding increases to ensure it can grow and facilitate new
projects. While CDC has the ability to fund meritorious proposals,
there will be no shortage of opportunities and the current investment
of $1.5 million will only go so far. Please increase funding for this
program to $5 million for FY 2022.
Adam Barbosa--Rhode Island
I am a 21 year-old resident of Rhode Island. I had my first
pancreatic episode at age 15. It wasn't until after my third attack,
and many medical tests later, that the Drs. told me I had two genetic
mutations (SPINK1 & CFTR) and a physical anomoly (pancreas divisum)
that were causing my attacks. I was officially diagnosed with chronic
pancreatitis. Since my first attack, my condition went on a downward
spiral. I went from a 3-day hospital stay every 5-6 months to a 7-day
stay every 2 months, then eventually every 2 weeks. At that point, my
case was so severe that the only option I had was to have the TPIAT
surgery at the University of Minnesota. The surgery lasted 14 hours,
required the removal of 4 organs [pancreas and spleen included], and
left me with post-operative cognitive dysfunction. A condition that has
crippled my college studies and hope for a ``normal'' future. Also,
without a pancreas, I became an instant Type-1 diabetic. I now have to
count carbs, dose myself with insulin and slug down a fistful of pills
[pancreatic enzymes] before anything I eat/drink . I suffer with
significant digestive issues and have lost 40 lbs. since surgery. Every
day is an intense physical, mental, and emotional struggle. I suffer
from depression, anxiety and panic attacks. Things I have come to find
patients with a chronic illness have to deal with on a daily basis.
There is no real ``Recovery'' from this surgery. My life is simply an
agonizing waiting game for medical advancements.
Jenny Jones--Illinois
I am 36 and live in Chicago, Illinois. I was 9 or 10 years old when
I experienced my first pancreatitis attack; my pediatrician at the time
ran blood work and immediately said I would need a liver transplant.
She also recommended we get a second opinion and see a GI pediatrician
specialist at another local hospital. After a full battery of tests,
the physician came to the conclusion that I probably had chronic
pancreatitis. I am glad that we went for the second opinion. I battled
this disease throughout my life, but it ceased after my ERCP from the
ages of 17-24. But, when I was 24 the pancreatitis had returned and by
then my sister was also diagnosed with pancreatitis. Life was ever more
challenging, the pain intolerable, and I could not imagine living
another 5-10 years this way. At this point, I had already become a Type
2 diabetic along with dealing with CP. In 2019, I had my 13-hour Total
Pancreatectomy Auto Islet Cell Transplant at the University of Chicago
Medicine on the South Side of Chicago where they removed my pancreas
and transferred any working islets from the pancreas into my liver,
removed half my stomach, small intestine, and duodenum. I am almost
one-year post op and although I am now Type 3C diabetic, I am glad I
choose to have the surgery. I am totally insulin-dependent and rely on
an insulin pump as my islets have not awakened yet. My life post-op has
been very challenging and I still deal with a measure of pain, and
digestive issues. Despite all the surgeries and debilitating illnesses
I have learned to become an advocate for others dealing with any
chronic debilitating illness.
Cecilia Petricone--Connecticut
My story with pancreatitis started at the age of 12-years-old. Just
a few weeks before I was supposed to start middle school I suddenly
woke up with excruciating abdominal pain. After the first
hospitalization, I started seeing lots of doctors including pancreatic
specialists, my official diagnosis became Idiopathic Recurrent Acute
Pancreatitis. During the first couple of years, I had genetic testing
done which showed I have a SPINK1 mutation, which made me more prone to
pancreatitis.
Doctors spent years trying to manage my symptoms. We tried changes
to my diet, getting more rest, staying extra hydrated, taking
precautions when I got onto airplanes, going on an anti-anxiety and
getting multiple pancreatic stents--nothing worked. In fact, my
condition worsened! My freshman year at Boston College was when things
really escalated. My yearly hospitalizations had become 2-3 a year and
my diagnosis transitioned from acute pancreatitis to chronic. My
sophomore year of college I made a visit to the ER, unaware that it was
the beginning of back-to-back pancreatitis attacks that left me living
in a hospital for the majority of time between October 2017 and
February 2018. I left school, finishing the fall semester partially
from a hospital bed 3 months later than my classmates. I lost a
significant amount of weight, was malnourished, and began losing my
hair.
That was until March, when my pancreatic specialist recommended I
consider getting a Total Pancreatectomy and Islet Auto Transplant
(TPIAT). In April of 2018, I had the surgery. Fast forward three years
later, I am in no pain and realize I am one of the lucky ones as having
the TPIAT does not guarantee a life of being pain-free. I have Type 3C
diabetes which I monitor and manage on a daily basis. While I am pain-
free, there are mental and emotional hurdles that come with medical
experiences as all-encompassing as this. I am deeply grateful to be
healthy and to no longer suffer from pancreatitis and I believe that
mental health is an incredibly important component of medical issues
that needs to be addressed.
Jane Holt--Rhode Island
My name is Jane Holt and I am a patient with chronic pancreatitis
from Rhode Island. My journey began in early January, 1988. I was at
home, asleep, with my husband and four young children. I woke up in the
middle of the night in excruciating pain. It felt as though my insides
were exploding. I knew immediately there was something terribly wrong
and I needed to go to the hospital. Ten days later my gall bladder was
removed, after the surgery, I told the surgeon that the original pain
was still there. I was able to get an appointment with a
gastroenterologist at BI Deaconess Hospital in Boston in October, 1988.
After doing a medical history and blood work my doctor said he thought
I had pancreatitis. I had an ERCP that confirmed this diagnosis.
Finally, a cause for the pain and it only took several months instead
of years for some patients. In November I had major surgery on my
pancreas to open the ducts to my pancreas and the journey continued.
Since then, I've had a few ERCPs, many MRCPs, CAT scans,
Ultrasound, and thousands and thousands of blood tests. I have
travelled to Mayo Clinic, Lahey Clinic, George Washington Hospital for
second opinions. My doctor has brought my records to many medical
meetings for input from other physicians. Over the last 32 years I have
done everything I can to try and fix this disease or at least find out
more about it. For most patients treatment hasn't changed. The only
treatment for patients is hospitalization and I would be hospitalized 3
or 4 times a year, sometimes for as long as a month. It is now even
getting harder to get the one thing that can help, pain medication. We
can't ignore patients like me. We have to do something to make a
difference for all of our patients.
[This statement was submitted by David Bakelman, Chief Executive
Officer,
National Pancreas Foundation.]
______
Prepared Statement of the National Respite Coalition
Mr. Chairman, I am Jill Kagan, Chair, National Respite Coalition
(NRC), a network of state respite coalitions, providers, caregivers,
and national, state and local organizations. We are requesting $14.2
million in the FY 2022 Labor, HHS, and Education Appropriations bill
for the Lifespan Respite Care Program administered by the
Administration for Community Living, Department of Health and Human
Services. The request is consistent with the Administration's request
to double funding for the program and will allow all States to receive
a Lifespan Respite Grant to help family caregivers, regardless of care
recipient's age or disability, access affordable respite. Additional
funding will help states improve respite quality; expand the respite
workforce; and use person and family-centered approaches that provide
family caregivers tailored information on how to find, use and pay for
respite services.
The pandemic cast a harsh light on the lack of supports for the
nation's family caregivers. When congregate and group settings became
too risky for older adults and people with disabilities, the importance
of family caregivers to providing care at home was greatly amplified.
At the same time, the availability of services, such as respite, became
harder to access. The Lifespan Respite network responded with flexible
respite and support options for family caregivers. During this
challenging time, this may have been the only support they received.
Respite Care Saves Money and Benefits Families. Now, more
importantly than ever, delaying a nursing home placement for
individuals with Alzheimer's or avoiding hospitalization for children
with autism can save Medicaid billions of dollars. Researchers at the
University of Pennsylvania studied records of 28,000 children with
autism enrolled in Medicaid and concluded that for every $1,000 states
spent on respite, there was an 8% drop in the odds of hospitalization
(Mandell, et al., 2012). Respite may help delay or avoid facility-based
placements (Gresham, 2018; Avison, et al., 2018), improve maternal
employment (Caldwell, 2007), strengthen marriages (Harper, 2013), and
reduce caregiver depression, stress and burden linked to caregiver
health (Broady and Aggar, 2017; Lopez-Hartmann, et al., 2012; Zarit, et
al., 2014).
With at least two-thirds (66%) of family caregivers in the
workforce (Mantos, 2015), U.S. businesses lose from $17.1 to $33.6
billion per year in lost productivity of employed caregivers (MetLife
Mature Market Institute, 2006). Higher absenteeism among working
caregivers costs the U.S. economy an estimated $25.2 billion annually
(Witters, 2011). The University of NE Medical Center conducted a survey
of caregivers receiving respite through the NE Lifespan Respite Program
and found that 36% of family caregivers reported not having enough
money at the end of the month to make ends meet, but families overall
reported a better financial situation when receiving respite (Johnson,
J., et al., 2018).
Who Needs Respite? About 53 million unpaid family caregivers of
adults provide care worth $470 billion annually (National Alliance for
Caregiving and AARP, 2020; Reinhard, SC, et al., 2019). Eighty percent
of those needing long-term services and supports (LTSS) are living at
home. Two-thirds of older people with disabilities receiving LTSS at
home receive care exclusively from family caregivers (Congressional
Budget Office, 2013).
Concerns about providing care for a growing aging population are
paramount. However, caregiving is a lifespan issue. The majority (54%)
of family caregivers care for someone between the ages of 18 and 75
(NAC and AARP, 2020). In addition, nearly 14 million children with
special health care needs require specialized care from parents and
guardians (Child and Adolescent Health Measurement Initiative, 2021).
Families caring for children with special health care needs provide
nearly $36 billion worth of care annually (Romley, et al., 2016).
National, State and local surveys have shown respite to be among
the most frequently requested services by family caregivers (Anderson,
L, et al., 2018; Maryland Caregivers Support Coordinating Council,
2015). Yet, 86% of family caregivers of adults did not receive respite
services at all in 2019 (NAC and AARP, 2020). Nearly half of family
caregivers of adults (44%) identified in the National Study of
Caregiving were providing substantial help with health care tasks, yet,
fewer than 17% used respite (Wolff, 2016). The percentage is similar
for parents of children with disabilities. The Elizabeth Dole
Foundation continues to recommend that respite should be more widely
available to military and Veteran caregivers.
Respite Barriers and the Effect on Family Caregivers. While most
families want to care for family members at home, research shows that
family caregivers are at risk for emotional, mental, and physical
health problems (American Psychological Association, 2012; Spillman,
J., et al., 2014). When caregivers lack effective coping styles or are
depressed, care recipients may be at risk for falling, developing
preventable secondary health conditions or limitations in functional
abilities. The risk of care recipient abuse increases when caregivers
are depressed or in poor health (American Psychological Association,
nd). Parents of children with special health care needs report poorer
general health, more physical health problems, worse sleep, and
increased depressive symptoms compared to parents of typically
developing children (McBean, A, et al., 2013).
Respite, that has been shown to ease family caregiver stress, is
too often out of reach or completely unavailable. In a survey of more
than 3000 caregivers of individuals with intellectual and developmental
disabilities (ID/DD), nine in ten reported that they were stressed.
Nearly half (49%) reported that finding time to meet their personal
needs was a major problem. Yet, more than half of the caregivers of
individuals with ID or Autism Spectrum Disorder reported that it was
difficult or very difficult to find respite care (Anderson, L., et al.,
2018). Respite may not exist at all for those with Alzheimer's, ALS,
MS, spinal cord or traumatic brain injuries, or children with serious
emotional conditions.
Barriers to accessing respite include fragmented and narrowly
targeted services, cost, and the lack of information about respite or
how to find or choose a provider. Moreover, a critically short supply
of well-trained respite providers or meaningful service options may
prohibit a family from making use of a service they so desperately
need.
Lifespan Respite Care Program Helps. The Lifespan Respite Care
Program, designed to address these barriers to respite quality,
affordability and accessibility, is a competitive grant program to
states administered by ACL in the Administration on Aging. The premise
behind the program is both care relief and cost effectiveness. Lifespan
Respite provides funding to states to expand and enhance local respite
services across the country, coordinate services to reduce duplication
and fragmentation, and improve respite access and quality.
Since 2009, 37 states and DC have received Lifespan Respite grants.
The program received $4.1 million in FY 18 and FY 19, and $6.1 million
in FY 2020. We are grateful for the increase to $7.1 million in FY
2021; however, the program received no emergency Congressional
supplemental funding during the pandemic, despite the elevated need.
With these funds, States are required to establish statewide
coordinated Lifespan Respite care systems to serve families regardless
of age or special need; provide planned and emergency respite care;
train and recruit respite workers and volunteers; and assist caregivers
in accessing respite. Lifespan Respite helps states maximize use of
limited resources and deliver services more efficiently to those most
in need. Increasing funding could allow funding for all states and help
current grantees complete their ground-breaking work in serving the
unserved, and ensuring sustainability by integrating services into
statewide No Wrong Door systems for long-term services and supports.
During the current pandemic, when family caregiver social isolation
is escalating, grantees and their primary partners continue to provide
respite safely in states where they are permitted to do so. They are
the frontline workers who may be the only outside contact and support
these families are receiving. If they cannot provide in-person respite,
the network has expanded support services to include regular phone call
check ins, delivery of care packages, online support groups, virtual
training and other educational services via Facebook and other social
media outlets.
How is Lifespan Respite Program Making a Difference? Key
accomplishments of State Lifespan Respite grantees are highlighted in a
new ARCH National Respite Network report, In Support of Caregivers
[archrespite.org/key-accomplishments]. State Lifespan Respite programs
are engaged in the following innovative activities:
--AL, AR, AZ, CO, DE, MD, MT, ND, NE, NV, NC, OK, RI, SC, TN, VA, WA,
and WI, administer successful self-directed respite vouchers
for underserved populations, such as individuals with
Alzheimer's disease, traumatic brain injury, MS or ALS, adults
with intellectual or developmental disabilities (I/DD), rural
caregivers, or those on waiting lists for services. When
families were willing and states allowed it, these programs
continued to operate with enhance flexibilities during the
pandemic.
--AL's respite voucher program found a substantial decrease in the
percentage of caregivers reporting how often they felt
overwhelmed with daily routines after receiving respite.
Caregivers in NE's Lifespan Respite program reported
significant decreases in stress levels, fewer physical and
emotional health issues, and reductions in anger and anxiety.
--Innovative and sustainable respite services, funded in AL, CO, MA,
NC, and NY through mini-grants to community-based agencies,
also have documented benefits to family caregivers.
--AL, MD, ND and NE offer emergency respite and AL, AR, CO, NE, NY,
PA, RI, SC and TN implemented new volunteer or faith-based
respite services.
--Respite provider recruitment and training are priorities in NE, NY,
SC, SD, VA, and WI.
State agency partnerships are changing the landscape. Lifespan
Respite WA, housed in Aging & Long-Term Support Administration,
partnered with WA's Children with Special Health Care Needs Program,
Tribal entities and the state's Traumatic Brain Injury program to
provide respite vouchers to families across ages and disabilities. The
OK Lifespan Respite program partnered with the state's Transit
Administration to develop mobile respite in isolated rural areas.
States, including NC, NY and NV, are building ``no wrong door systems''
in partnership with Aging and Disability Resource Centers to improve
respite access. States are developing long-term sustainability plans,
but without continued federal support, many grantees will be cut off
before these initiatives achieve their full impact.
During the pandemic, social isolation and severe mental health
issues among family caregivers intensified. The CDC found that ``unpaid
adult caregivers reported having experienced disproportionately worse
mental health outcomes, increased substance use, and elevated suicidal
ideation.'' The Lifespan Respite network responded with flexible and
innovative respite options. For countless caregivers, respite became
their only lifeline to supports, services, and vital human connection.
OK, ND, NV, WA, VA, and WI were some of the states that introduced
flexibility to their respite voucher programs to encourage use, such as
expanded eligibility and timeframes, increased flexibility in who could
provide respite to include other family members in the home, and
increased voucher amounts. Other Lifespan Respite grantees met the
needs of family caregivers through new and creative approaches:
Alabama: Alabama Lifespan Respite, in order to increase targeted
support to caregivers during the pandemic, offered Care Chats (one-on-
one support by phone or video conferencing) with their social worker
staff, monthly support groups, and caregiver mental health education
opportunities to help increase overall caregiver wellness. Alabama
Lifespan Respite also introduced a Caregiver Wellness Initiative that
increases Emergency Respite reimbursement funds and designates funds
specifically for mental health counseling to caregivers currently
enrolled with their reimbursement (voucher) program. The intended
impacts of the Caregiver Wellness Initiative include decreases in
caregiver stress, anxiety, fatigue, and burnout after receiving
Emergency Respite and/or mental health counseling.
Tennessee: The TN Respite Coalition awarded mini-grants for
caregiver-selected items, such as personal protective equipment,
tablets enabling internet access to online support groups, home
exercise equipment, and movie or magazine subscriptions. Expanding
ideas of traditional respite services, the Tennessee Respite Voucher
Program provided respite in innovative ways that allowed for safe
social distancing but maintained caregiver-provider contact that kept
caregivers socially connected during times of increased stress and
isolation.
No other federal program has respite as its sole focus, helps
ensure respite quality or choice, and supports respite start-up,
training or coordination. We urge you to include $14.2 million in the
FY 2022 Labor, HHS, and Education appropriations bill. Families will be
able to keep loved ones at home safely and ensure their own well-being,
saving Medicaid and other federal programs billions of dollars.
For more information, please contact Jill Kagan, National Respite
Coalition at [email protected]. Complete references available on
request.
[This statement was submitted by Jill Kagan, Chair, National
Respite Coalition.]
______
Prepared Statement of the National Technical Institute for the Deaf
Mr. Chairman and Members of the Committee:
I respectfully submit the FY 2022 budget request for NTID, one of
nine colleges of RIT, in Rochester, New York. Created by Congress by
Public Law 89-36 in 1965, NTID provides a university-level technical
and professional education for students who are deaf and hard of
hearing, leading to successful careers in high-demand fields for a sub-
population of individuals historically facing high rates of
unemployment and under-employment. NTID students study at the
associate, baccalaureate, master's and doctoral levels as part of a
university (RIT) that includes more than 17,000 hearing students. NTID
also provides baccalaureate and graduate-level education for hearing
students in professions serving deaf and hard-of-hearing individuals.
budget request
On behalf of NTID, for FY 2022 I would like to request $89,700,000
for Operations. NTID has worked hard to manage its resources carefully
and responsibly. NTID actively seeks alternative sources of public and
private support, with approximately 24% of NTID's Operations budget
coming from non-federal funds, up from 9% in 1970. Since FY 2006, NTID
raised more than $26 million in support from individuals and
organizations.
NTID's FY 2022 request of $89,700,000 includes $3,400,000 for
establishing a national hub of innovation for deaf scientists in
Rochester, New York. The ``Hub'' will be a collaborative partnership
with the University of Rochester and Rochester Regional Health that
will enhance the access of deaf and hard-of-hearing persons to career
opportunities as scientists, biomedical researchers and health
professionals. Hub programs will include a summer research program, a
pre-career training pipeline for deaf and hard-of-hearing scientists,
mentoring programs, a postdoc-to-faculty program, and guidance for
biomedical research institutions and medical schools on best practices
for training deaf and hard-of-hearing scientists and health
professionals. The coronavirus has also demonstrated the national need
for timely, accurate and official information in ASL about pandemics
and health care concerns--a service the Hub could provide.
NTID's FY 2022 request also includes an additional $2,000,000 to
expand the NTID Regional STEM Center (NRSC) partnership, which serves
deaf and hard-of-hearing students in 12 southeastern states by
promoting training and postsecondary participation in STEM fields,
providing professional development for teachers, and developing
partnerships with business and industry to promote employment
opportunities. Via the NRSC, deaf and hard-of-hearing middle school
students are introduced to STEM programs and careers that will help
inform their academic and career decisions. Deaf and hard-of-hearing
high school students can take NTID STEM dual-credit courses and
participate in career exploration and college preparation programs that
will help them transition from high school to college. In FY 2020, up
to 2,023 educators, 1,685 students, 590 employers, 379 interpreters,
241 parents, and 190 vocational rehabilitation staff enrolled in NRSC
programs (some may have enrolled in multiple programs).
NTID's FY 2022 operations request also provides $700,000 to
establish a Computer Science and Cybersecurity Training Center for deaf
and hard-of-hearing students based at RIT's new Global Cybersecurity
Institute (GCI), a 52,000-square-feet facility providing students,
researchers and industry professionals with the most advanced
technology tools and education offerings to help further digital
security across the world. The Cybersecurity Training Center would
allow NTID to build on its new partnership with the GCI, which is
currently offering a boot camp to deaf and hard-of-hearing students
that results in an RIT GCI Cybersecurity Bootcamp Certificate and
preparation for industry-standard certifications, including CompTIA
Security+ and Cybersecurity First Responder. Finally, the requested
increase in operations will also provide $2,100,000 for NTID to manage
inflationary costs.
enrollment
Truly a national program, NTID has enrolled students from all 50
states. In Fall 2020 (FY 2021), NTID's enrollment was 1,101 students.
NTID also serves students nationwide through Project Fast Forward, a
project that builds a pathway for deaf and hard-of-hearing students to
transition from high school to college in selected STEM disciplines by
allowing deaf and hard-of-hearing high school students to take dual-
credit courses, earning RIT/NTID college credit while they are still in
high school. In FY 2021, 185 deaf and hard-of-hearing high school
students enrolled in dual-credit courses at partner high schools.
ntid academic programs
NTID offers high quality, career-focused associate degree programs
preparing students for specific well-paying technical careers. NTID
also provides transfer associate degree programs to better serve our
student population seeking bachelor's, master's, and doctoral degrees.
These transfer programs provide seamless transition to baccalaureate
and graduate studies in the other colleges of RIT.
A cooperative education (co-op) component is an integral part of
academic programming at NTID and prepares students for success in the
job market. A co-op assignment gives students the opportunity to
experience a real-life job situation and focus their career choice.
Students develop technical skills and enhance vital personal skills
such as teamwork and communication, which will make them better
candidates for full-time employment after graduation. Last year, 181
students participated in 10-week co-op experiences that augment their
academic studies, refine their social skills, and prepare them for the
competitive working world.
student accomplishments
NTID deaf and hard-of-hearing students persist and graduate at
rates higher than or on par with national persistence and graduation
rates for all students at two-year and four-year colleges. For NTID
deaf and hard-of-hearing graduates, over the past five years, an
average of 95% have found jobs commensurate with their education level.
Of our FY 2019 graduates (the most recent class for which numbers are
available), 95% were employed one year later, with 77% employed in
business and industry, 16% in education and non-profits, and 7% in
government.
Graduation from NTID has a demonstrably positive effect on
students' earnings over a lifetime, and results in a notable reduction
in dependence on Supplemental Security Income (SSI) and Social Security
Disability Insurance (SSDI). In FY 2012, NTID, the Social Security
Administration (SSA), and Cornell University examined earnings and
federal program participation data for more than 16,000 deaf and hard-
of-hearing individuals who applied to NTID over our entire history. The
study showed that NTID graduates, over their lifetimes, are employed at
a higher rate and earn more (therefore paying more in taxes) than
students who withdraw from NTID or attend other universities. NTID
graduates also participate at a lower rate in SSI programs than
students who withdrew from NTID.
Using SSA data, at age 50, 78% of NTID deaf and hard-of-hearing
graduates with bachelor degrees and 73% with associate degrees report
earnings, compared to 58% of NTID deaf and hard-of-hearing students who
withdrew from NTID and 69% of deaf and hard-of-hearing graduates from
other universities. Equally important is the demonstrated impact of an
NTID education on graduates' earnings. At age 50, $58,000 is the median
salary for NTID deaf and hard-of-hearing graduates with bachelor
degrees and $41,000 for those with associate degrees, compared to
$34,000 for deaf and hard-of-hearing students who withdrew from NTID
and $21,000 for deaf and hard-of-hearing graduates from other
universities.
An NTID education also translates into reduced dependency on
federal transfer programs, such as SSI and SSDI. At age 40, less than
2% of NTID deaf and hard-of-hearing associate and bachelor degree
graduates participated in the SSI program compared to 8% of deaf and
hard-of-hearing students who withdrew from NTID. Similarly, at age 50,
only 18% of NTID deaf and hard-of-hearing bachelor degree graduates and
28% of associate degree graduates participated in the SSDI program,
compared to 35% of deaf and hard-of-hearing students who withdrew from
NTID.
access services
Access services include sign language interpreting, real-time
captioning, classroom notetaking services, captioned classroom video
materials, and assistive listening services. NTID provides an access
services system to meet the needs of a large number of deaf and hard-
of-hearing students enrolled in baccalaureate and graduate degree
programs in RIT's other colleges as well as students enrolled in NTID
programs who take courses in the other colleges of RIT. Access services
also are provided for events and activities throughout the RIT
community. Historically, NTID has followed a direct instruction model
for its associate-level classes, with limited need for sign language
interpreters, captionists, or other access services. However, the
demand for access services has grown recently as associate-level
students request communication based on their preferences.
During FY 2020, 118,240 hours of interpreting and 21,856 hours of
real-time captioning were provided to students.
summary
NTID's FY 2022 funding request ensures that we continue our mission
to prepare deaf and hard-of-hearing people to excel in the workplace
and expand our outreach to better prepare deaf and hard-of-hearing
students to excel in college. NTID students persist and graduate at
rates higher than or on par with national rates for all students. NTID
graduates have higher salaries, pay more taxes, and are less reliant on
federal SSI programs. NTID's employment rate is 95% over the past five
years. Therefore, I ask that you please consider funding our FY 2022
request of $89,700,000 for Operations.
We are hopeful that the members of the Committee will agree that
NTID, with its long history of successful stewardship of federal funds
and an outstanding educational record of service to people who are deaf
and hard of hearing, remains deserving of your support and confidence.
Likewise, we will continue to demonstrate to Congress and the American
people that NTID is a proven economic investment in the future of young
deaf and hard-of-hearing citizens. Quite simply, NTID is a federal
program that works.
[This statement was submitted by Dr. Gerard J. Buckley, President,
National Technical Institute for the Deaf and Vice President and Dean,
Rochester Institute of Technology.]
______
Prepared Statement of the National Viral Hepatitis Roundtable
Dear Chairwoman Murray, Ranking Member Blunt, and members of the
subcommittee,
I am writing on behalf of the National Viral Hepatitis Roundtable
(NVHR), a coalition of patients, health care providers, community-based
organizations, and public health partners fighting for an equitable
world free of viral hepatitis. We are respectfully requesting an
increase in funding to CDC's Division of Viral Hepatitis (DVH), to no
less than $134 million in FY 2022 from its current level of $39.5
million for FY 2021.
According to data released by the CDC last month, cases of acute
hepatitis A increased by a staggering 1300% between 2015 and 2019,
representing outbreaks of person-to-person transmission of this
vaccine-preventable infection linked to substance use and homelessness.
While reported rates of new hepatitis B infections generally remained
stable over this period, the overwhelming majority occurred among
unvaccinated adults between the ages of 30 and 59, with a substantial
number of cases linked to injection drug use. Over this time period,
acute hepatitis C cases surged by 63%, with estimated new infections
now exceeding annual rates of new HIV infections in the United States.
Specifically, CDC estimates 57,500 new hepatitis C infections for 2019,
while noting that the true number could be as high as 196,000.
The tragedy of our viral hepatitis response is that these cases
reflect failures in prevention, exacerbations in health disparities,
and gaps in our public health system. We have strong tools--including
vaccination for hepatitis A and B, alongside syringe services programs
and medication-assisted treatment for opioid use disorder for hepatitis
C--proven effective and well-established in preventing new infections,
when implemented comprehensively and at scale. Chronic hepatitis B is
treatable and chronic hepatitis C is curable, and indeed CDC's
surveillance data and 2021 National Viral Hepatitis Progress Report
show promising momentum in decreasing mortality from hepatitis B and
hepatitis C, including among communities burdened with substantial
racial/ethnic health disparities (Asian and Pacific Islander
communities for hepatitis B, and American Indian/Alaskan Native persons
and African Americans for hepatitis C).
The Department of Health and Human Services released a new National
Viral Hepatitis Strategic Plan at the beginning of 2021, committing the
nation to eliminate viral hepatitis as a public health threat by 2030
and outlining a comprehensive and credible set of strategies and
priorities to achieve this goal. However, we cannot meet this challenge
without reckoning with the persistent underfunding of viral hepatitis
within the CDC budget, a chronic shortfall that cascades down to states
and local communities struggling to keep pace with shifting trends and
increased new cases as a downstream consequence of the broader opioid
and stimulant health crisis. CDC's Division of Viral Hepatitis plays an
essential role in leading our public health efforts towards viral
hepatitis elimination, but can only fulfill that promise with adequate
resources. We strongly urge the subcommittee to strengthen our public
health infrastructure by investing at least $134 million in CDC's
Division of Viral Hepatitis for FY 2022.
In tandem with this investment, we respectfully request that the
subcommittee increases CDC's funding for eliminating opioid-related
infectious diseases to $120 million in FY 2022, to accelerate urgent
efforts to support building out programmatic infrastructure--
particularly syringe services programs (SSPs)--capable of prevention
and linkage to care for not only HIV and viral hepatitis but other
infectious diseases such as endocarditis which disproportionately
affect people who inject drugs. These programs continue to serve on the
frontlines of both the COVID-19 pandemic and the overdose epidemic,
uniquely effective at engaging a highly vulnerable and marginalized
population that other systems--including health care--struggle to
engage, serve, and retain in a timely and effective manner. In keeping
with the vital importance of resourcing these programs, we similarly
urge the subcommittee to remove restrictions on the use of federal
funds to purchase sterile syringes in order to maximize the impact and
benefits of these programs.
In conclusion, we thank the subcommittee for their commitment to
public health and attention to viral hepatitis, and would be eager to
respond to questions or provide additional information and context to
support your work.
[This statement was submitted by Daniel Raymond, Director of
Policy, National Viral Hepatitis Roundtable.]
______
Prepared Statement of the NephCure Kidney International
summary of recommendations for fiscal year 2022
_______________________________________________________________________
--Provide $46.1 billion for the National Institutes of Health (NIH)
--Provide a proportional increase for the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK) and the
National Institute on Minority Health and Health Disparities
(NIMHD) and support the expansion of the FSGS/NS research
portfolio at NIDDK and NIMHD by funding more research into
primary glomerular disease.
--Provide $10 billion for the Centers for Disease Control and
Prevention (CDC) and $5 million for the Chronic Disease
Education and Awareness Program.
_______________________________________________________________________
Chairwoman Murray and Ranking Member Blunt, thank you for the
opportunity to present the views of NephCure Kidney International
regarding research on focal segmental glomerulosclerosis (FSGS) and
nephrotic syndrome (NS). NephCure is the only non-profit organization
exclusively devoted to finding a cure and supporting patients with FSGS
and the NS disease group. Driven by a panel of respected medical
experts and a dedicated band of patients and families, NephCure works
tirelessly to support kidney disease research and awareness.
NS is a collection of signs and symptoms caused by diseases that
attack the kidney's filtering system. These diseases include FSGS,
Minimal Change Disease and Membranous Nephropathy and others. When
affected, the kidney filters leak protein from the blood into the urine
and often cause kidney failure, which requires dialysis or kidney
transplantation. According to a Harvard University report, 73,000
people in the United States have lost their kidneys as a result of
FSGS. Unfortunately, the causes of FSGS and other 'filter related'
diseases are poorly understood.
FSGS is the second leading cause of NS and is especially difficult
to treat. There is no known cure for FSGS and current treatments are
difficult for patients to endure. These treatments include the use of
steroids and other dangerous substances which lower the immune system
and contribute to severe bacterial infections, high blood pressure and
other problems in patients, particularly child patients. In addition,
children with NS often experience growth retardation and heart disease.
Finally, NS that is caused by FSGS, MCD or MN is idiopathic and can
often reoccur, even after a kidney transplant.
FSGS disproportionately affects minority populations and is five
times more prevalent in the African American community. In a
groundbreaking study funded by NIH, researchers found that FSGS is
associated with two aggressive APOL1 gene variants. 75% of Black
Americans with FSGS possess this gene. These variants developed as an
evolutionary response to African sleeping sickness and are common in
the African American patient population with FSGS/NS. Researchers
continue to study the pathogenesis of these variants.
FSGS has a large social impact in the United States. FSGS leads to
end-stage renal disease (ESRD) which is one of the most costly chronic
diseases to manage. In 2008, the Medicare program alone spent $26.8
billion, 7.9% of its entire budget, on ESRD. In 2005, FSGS accounted
for 12% of ESRD cases in the U.S., at an annual cost of $3 billion. It
is estimated that there are currently approximately 20,000 Americans
living with ESRD due to FSGS.
Research on FSGS and other forms of NS could achieve tremendous
savings in federal health care costs and reduce health status
disparities.
encourage fsgs/ns research at nih
There is no known cause or cure for FSGS and scientists tell us
that much more research needs to be done on the basic science behind
FSGS/NS. More research could lead to fewer patients undergoing ESRD and
tremendous savings in health care costs in the United States. NephCure
works closely with NIH and has partnered with NIH on two large studies
that will advance the pace of clinical research and support precision
medicine. These studies are the Nephrotic Syndrome Study Network
(NEPTUNE) and the Cure Glomerulonephropathy Network (CureGN).
With collaboration from other Institutes and Centers, ORDR
established the Rare Disease Clinical Research Network. This network
provided an opportunity for NephCure Kidney International, the
University of Michigan, and other university research health centers to
come together to form the NEPTUNE. Now in its second 5-year funding
cycle, NEPTUNE has recruited over 450 NS research participants, and has
supported pilot and ancillary studies utilizing the NEPTUNE data
resources. NephCure urges the subcommittee to continue its support for
RDCRN and NEPTUNE, which has tremendous potential to facilitate
advancements in NS and FSGS research.
NIDDK houses the Cure GN, a multicenter five-year cohort study of
glomerular disease patients. Participants will be followed
longitudinally to better understand the causes of disease, response to
therapy, and disease progression, with the ultimate objective to cure
glomerulonephropathy. NephCure recommends that the subcommittee
continues to support the work that the CureGN initiative has
accomplished towards further understanding rare forms of kidney
diseases. It is estimated that annually there are 20 new cases of ESRD
per million African Americans due to FSGS, and 5 new cases per million
Caucasians. This disparity is largely due to variants of the APOL1
gene. Unfortunately, the incidence of FSGS is rising and there are no
known strategies to prevent or treat kidney disease in individuals with
the APOL1 genotype. NIMHD began supporting research on the APOL1 gene
in FY13. Due to the disproportionate burden of FSGS on minority
populations, it remains appropriate for NIMHD to continue to advance
this research. NephCure asks the subcommittee to recognize the work
that NIMHD and NIDDK are doing to address the connection between the
APOL1 gene and the onset of FSGS and encourage NIMHD to work with
community stakeholders to identify areas of collaboration.
As a result of the important research done through NIH we have been
able to work with FDA to establish new endpoints for clinical trial
leading to more trials than ever before. This has led to the creation
of the Kidney Health Gateway Clinical that will connect patients with
breakthrough clinical trials and access top Nephrotic Syndrome doctors
all in one place. These crucial trials will hopefully lead to more
treatment options for our patients.
CHRONIC DISEASE EDUCATION AND AWARENESS
We thank the Subcommittee for the creation of the Chronic Disease
Education and Awareness Program in FY2021 and encourage continued
support by providing $5 million for this critical program in FY2022.
Patient Perspective
Meet 13-year-old Macy! She was diagnosed with Nephrotic Syndrome
and later FSGS when she was three. Her 10-year journey with kidney
disease has been long and hard. Macy did not respond to treatments for
her kidney disease and within two years of diagnosis, her native
kidneys were damaged beyond repair and she was in kidney failure and on
dialysis. At the age of five, she received a living donor kidney
transplant, but her disease, FSGS came back and attacked her new to her
kidney. It took a full year of aggressive treatments to get Macy's FSGS
into remission post-transplant. For the past 10 years, Macy has taken
18 to 26 medications a day. Those medications and her kidney disease
have led to multiple co-morbidities. She is currently followed by 7
specialties, has endured 30+ surgeries & been hospitalized over 100
times. Macy participates in the Beads of Courage program in which she
earns different beads for each procedure, appointment etc. The strand
of beads you see in this photo are just the beads she earned in 2018!
Those black beads are for pokes (lab draws, IV's, Shots) and Macy
earned over 400 last year. As you can see kidney disease is tough!
Although Macy continues to struggle with kidney disease and will need
another transplant sooner than later, she doesn't let that stop her
from living life! Macy loves dancing and musical theater, art, and
hanging out with her dog Bentley!
Thank you for the opportunity to present the views of the FSGS/NS
community.
[This statement was submitted by Irving Smokler, PH.D., Board
Chairman, Acting President and Founder, NephCure Kidney International.]
______
Prepared Statement of the Neurofibromatosis Network
Thank you for the opportunity to submit testimony to the
Subcommittee on the importance of funding for the National Institutes
of Health (NIH), and specifically for continued research on
Neurofibromatosis (NF), a genetic disorder closely linked to many
common diseases widespread among the American population. My name is
Kim Bischoff and I am the Executive Director of the Neurofibromatosis
(NF) Network, a national organization of NF advocacy groups. We
respectfully request that you include the following report language on
NF research at the National Institutes of Health within the Office of
the Director account in the Fiscal Year 2022 Labor, Health and Human
Services, Education Appropriations bill.
Neurofibromatosis [NF].--The Committee supports efforts to increase
funding and resources for NF research and treatment at multiple
Institutes, including NCI, NINDS, NIDCD, NHLBI, NICHD, NIMH, NCATS, and
NEI. Children and adults with NF are at elevated risk for the
development of many forms of cancer, as well as deafness, blindness,
developmental delays and autism; the Committee encourages NCI to
increase its NF research portfolio in fundamental laboratory science,
patient-directed research, and clinical trials focused on NF-associated
benign and malignant cancers. The Committee also encourages NCI to
support clinical and preclinical trials consortia. Because NF can cause
blindness, pain, and hearing loss, the Committee urges NINDS to
continue to aggressively fund fundamental basic science research on NF
relevant to restoring normal nerve function. Based on emerging findings
from numerous researchers worldwide demonstrating that children with NF
are at significant risk for autism, learning disabilities, motor
delays, and attention deficits, the Committee encourages NINDS, NIMH,
and NICHD to increase their investments in laboratory-based and
patient-directed research investigations in these areas. Since NF2
accounts for approximately 5 percent of genetic forms of deafness, the
Committee encourages NIDCD to expand its investment in NF2-related
research. NFl can cause vision loss due to optic gliomas. The Committee
encourages NEI to expand its investment in NF1-focused research on
optic gliomas and vision restoration.
On behalf of the Neurofibromatosis (NF) Network, I speak on behalf
of the over 100,000 Americans who suffer from NF as well as the
millions of Americans who suffer from diseases and conditions linked to
NF such as cancer, brain tumors, heart disease, memory loss, and
learning disabilities. Thanks in large part to this Subcommittee's
strong support, scientists have made enormous progress since the
discovery of the NF1 gene in 1990 resulting in clinical trials now
being undertaken at NIH with broad implications for the general
population.
NF is a genetic disorder involving the uncontrolled growth of
tumors along the nervous system which can result in terrible
disfigurement, deformity, deafness, pain, blindness, brain tumors,
cancer, and even death. In addition, approximately one-half of children
with NF suffer from learning disabilities. NF is the most common
neurological disorder caused by a single gene and is more common than
Cystic Fibrosis, hereditary Muscular Dystrophy, Huntington's disease
and Tay Sachs combined. There are three types of NF: NF1, which is more
common, NF2, which initially involves tumors causing deafness and
balance problems, and Schwannomatosis, the hallmark of which is severe
pain. While not all NF patients suffer from the most severe symptoms,
all NF patients and their families live with the uncertainty of not
knowing whether they will be seriously affected because NF is a highly
variable and progressive disease.
Researchers have determined that NF is closely linked to heart
disease, learning disabilities, memory loss, cancer, brain tumors, and
other disorders including deafness, blindness and orthopedic disorders,
primarily because NF regulates important pathways common to these
disorders such as the RAS, cAMP and PAK pathways. Research on NF
therefore stands to benefit millions of Americans.
Learning Disabilities/Behavioral and Brain Function
Learning disabilities affect one-half of people with NF1. They
range from mild to severe and can impact the quality of life for those
with NF1. In recent years, research has revealed common threads between
NF1 learning disabilities, autism, and other related disabilities. New
drug interventions for learning disabilities are being developed and
will be beneficial to the general population. Research being done in
this area includes working to identify drugs that target Cyclic AMP, so
they can be paired with existing drugs targeting RAS. Identification of
new drug combinations may benefit people with multiple types of
learning disabilities.
Bone Repair
At least a quarter of children with NF1 have abnormal bone growth
in any part of the skeleton. In the legs, the long bones are weak,
prone to fracture and unable to heal properly; this can require
amputation at a young age. Adults with NF1 also have low bone mineral
density, placing them at risk of skeletal weakness and injury. Research
currently being done to understand bone biology and repair will pave
the way for new strategies to enhancing bone health and facilitating
repair.
Pain Management
Severe pain is a central feature of Schwannomatosis, and
significantly impacts quality of life. Understanding what causes pain,
and how it could be treated, has been a fast-moving area of NF research
over the past few years. Pain management is a challenging area of
research and new approaches are highly sought after.
Nerve Regeneration
NF often requires surgical removal of nerve tumors, which can lead
to nerve paralysis and loss of function. Understanding the changes that
occur in a nerve after surgery, and how it might be regenerated and
functionally restored, will have significant quality of life value for
affected individuals. Light-based therapy is being tested to dissect
nerves in surgery of tumor removal. If successful it could have
applications for treating nerve damage and scarring after injury,
thereby aiding repair and functional restoration.
Cancer
NF can cause a variety of tumors to grow, which includes tumors in
the brain, spinal cord and nerves. NF affects the RAS pathway which is
implicated in 70% of all human cancers. Some of these tumor types are
benign and some are malignant, hard to treat and often fatal. Previous
studies have found a high incidence of intracranial glioblastomas and
malignant peripheral nerve sheath tumors (MPNSTs), as well as a six-
fold incidents of breast cancer compared to the general population. One
of these tumor types, malignant peripheral nerve sheath tumor (MPNST),
is a very aggressive, hard to treat and often fatal cancer. MPNSTs are
fast growing, and because the cells change as the tumor grows, they
often become resistant to individual drugs. Clinical trials are
underway to identify a drug treatment that can be widely used in MPNSTs
and other hard-to-treat tumors.
The enormous promise of NF research, and its potential to benefit
over 175 million Americans who suffer from diseases and conditions
linked to NF, has gained increased recognition from Congress and the
NIH. This is evidenced by the fact that numerous institutes are
currently supporting NF research, and NIH's total NF research portfolio
has increased from $3 million in FY1990 to an estimated $36 million in
FY2021. Given the potential offered by NF research for progress against
a range of diseases, we are hopeful that the NIH will continue to build
on the successes of this program by funding this promising research and
thereby continuing the enormous return on the taxpayers' investment.
We appreciate the Subcommittee's strong support for the National
Institutes of Health and will continue to work with you to ensure that
opportunities for major advances in NF research at the NIH are
aggressively pursued. Thank you.
[This statement was submitted by Kim Bischoff, Executive Director,
Neurofibromatosis Network.]
______
Prepared Statement of the Northwest Portland Area Indian Health Board
Greetings Chair Murray, Ranking Member Blunt, and Members of the
Subcommittee, for the opportunity to share the Northwest Portland Area
Indian Health Board's funding priorities for the Department of Health
and Human Services (HHS) in FY 2022. My name is Nickolaus Lewis, and I
serve as Council on the Lummi Indian Business Council, and as Chair of
the Northwest Portland Area Indian Health Board (NPAIHB or Board). I
thank the Subcommittee for the opportunity to provide testimony on FY
2022 HHS appropriations.
The NPAIHB is a tribal organization, established in 1972, under the
Indian Self-Determination and Education Assistance Act (ISDEAA), P.L.
93-638 that advocates on behalf of the 43 federally-recognized Indian
Tribes in Idaho, Oregon, and Washington on specific health care issues.
The Board's mission is to eliminate health disparities and improve the
quality of life of American Indian and Alaska Native (AI/AN) people by
supporting Northwest Tribes in the delivery of culturally appropriate,
high quality health programs and services. ``Wellness for the seventh
generation'' is the Board's vision. In order to achieve this vision,
NPAIHB delegates respectfully ask that this Subcommittee consider
tribal sovereignty, traditional knowledge, and culture in all policy
initiatives and funding opportunities.
Last year, COVID-19 dramatically impacted Northwest Tribes. We are
grateful for the diligent work of our Congressional representatives in
ensuring that Tribal Nations were provided with resources, including
vaccines, to battle this pandemic. We know that working together
improved our ability take care of our people despite the long standing
systemic and funding shortfalls to the Indian health care system. As we
emerge from the pandemic, I make recommendations that will help rebuild
and repair the foundational necessities for the Indian health care
system.
hhs and its agencies
This Committee must honor tribal sovereignty and trust and treaty
obligations as to HHS funding to Tribal Nations. For FY 2022, we ask
this Committee to make the legislative changes needed across all HHS
agencies to move away from grants and allocate funding to tribes
through Indian Self-Determination and Education Assistance Act (ISDEAA)
compacts and contracts. We also request Tribal set-asides and direct
funding to tribes--not through state block grants.
We also request that this Committee consider the important role
that Tribal Epidemiology Centers play in the Indian health system and
support funding to TECs. TECs should be funded across HHS agencies to
provide support to tribes in their area for any type of data or
evaluation component, surveillance support and/or training and
technical assistance. TECs know the tribes in their area and should be
given the opportunity to support tribes in their roles as public health
authorities.
substance abuse and mental health services administration
Tribal Opioid Response. Through Tribal Opioid Response (TOR)
funding, NPAIHB coordinated a TOR consortium of 28 Northwest Tribes.
Our tribes have developed innovative opioid programs with positive
outcomes reflecting the resilience in our area. For example, the Lummi
Nation brought on success coaches (peers) for those using or in
recovery and 18 of the 28 TOR consortium tribes have made medication-
assisted treatment (MAT) available. However, a funding increase is
needed for a more robust opioid response in tribal communities. In FY
2022, we request an increase in TOR funding to $75 million; and an
increase in the Tribal MAT funding to $20 million.
Other Grant Programs. Thank you for the increases to the AI/AN Zero
Suicide Initiative funding, and Tribal Behavioral Health Grants in FY
2021. For FY 2022, we request the following amounts for Tribal Specific
Programs: fund the Tribal Behavioral Health Grant program at least $50
million--$25 million for mental health and $25 million for substance
use disorder; fund the Garrett Lee Smith Suicide Prevention Tribal Set
Aside at $3.5 million; fund Zero Suicide Initiative at $3 million; and
fund the National Child Traumatic Stress Initiative Tribal Set Aside at
$1.5 million.
Designated Resources for Youth Behavioral Health Programs. In order
to comprehensively address the need for whole person mental health and
substance use disorder services for AI/AN youth, there must be
dedicated funding streams for culturally-centered prevention,
intervention, treatment, aftercare and transitional living support.
Funding for Youth Residential Treatment Centers that provide aftercare
and transitional living for both substance use disorder and mental
health are a priority for Portland Area Tribes and current facilities
in the area do not meet demand. For FY 2022, we request $25 million in
funding for youth-specific outpatient and inpatient mental health and
substance use programs.
office of the secretary
Minority HIV/AIDS Fund. The Minority HIV/AIDS Fund is a significant
funding source for communities of color that have not traditionally
been supported by mainstream opportunities, and includes important
funding to IHS for HIV and hepatitis C (HCV) prevention, treatment,
outreach and education. Tribes in the Portland Area appreciated the
$1.5 million MHAF Tribal set-aside in FY 2021. For FY 2022, we request
that funding for Minority HIV/AIDS Fund be increased to $80 million
with a $15 million Tribal set-aside. This is a step toward addressing
the impact that HIV has in Indian Country.
centers for disease control and prevention (cdc)
Public Health Infrastructure & Environmental Impacts. COVID-19 has
demonstrated the under-investment made by the federal government in
public health and medical care infrastructure in the Indian, Tribal,
and Urban (I/T/U) health system. The I/T/U system is underfunded, and
lacks capacity to respond effectively to public health emergencies like
COVID-19. We can no longer allow population density as the primary
consideration in the allocation of emergency preparedness resources. In
FY 2022, we request at least $1 billion for a Tribal Public Health
Emergency Fund established through the Secretary of HHS that tribes can
access directly for tribally-declared public health emergencies.
Include Tribes in HIV/HCV Funding Opportunities. HIV/HCV prevention
and education generally flows to states via block grants. This leaves
many tribes with limited or no resources and forces tribes to compete
with states for funding. For FY 2022, we recommend that the Committee
set-aside at least $25 million for HIV and HCV prevention for Tribal
communities.
Fund Good Health and Wellness in Indian Country (GHWIC). The GHWIC
initiative supports AI/AN communities in the implementation of holistic
and culturally adapted approaches to reduce and prevent chronic disease
through policy, system and environment changes. With COVID-19, tribal
communities are more focused than ever on the importance of traditional
foods and the nutritional and healing qualities of these food in a time
of crisis. Additional funding is needed to address food access issues,
food insecurity, and support traditional food and local food system
initiatives beyond COVID-19. NPAIHB recommends that the Committee
allocate at least $32 million in FY 2022 to the Good Health and
Wellness in Indian Country.
centers for medicare and medicaid services (cms)
Medicaid Legislative Initiative. HHS must work with Congress to
pass legislation that creates the authority for states to extend
Medicaid eligibility to all AI/AN people with household incomes up to
138% of the federal poverty level; authorizes Indian Health Care
Providers (IHCP) in all states to receive Medicaid reimbursement for
health care services delivered to AI/AN people under IHCIA; extends
100% FMAP to states for Medicaid services furnished by urban Indian
providers permanently; excludes Indian-specific Medicaid provisions in
federal law from state waiver authority; and removes the limitation on
billing by IHCP for services provided outside the four walls of a
tribal clinic.
Medicare Telehealth Reimbursement. Medicare telehealth expansion is
set to expire at the end of the current public health emergency.
Telehealth provided a way to care for our people during the pandemic
and should be made permanent to increase access. We request that this
Committee support legislation to make Medicare telehealth flexibilities
permanent at the OMB encounter rate at I/T/U facilities, expand
telephone-only telehealth visits, direct physician supervision of non-
physician providers be provided remotely via telephone, and expand
``originating site'' locations from which telehealth services can be
received, and support inclusion of multiple platforms including
FaceTime, Zoom, and Skype.
Dental Health Aide Therapists Reimbursement. In Washington, tribes
have faced barriers to get the state plan amendment in Washington
approved to include dental health aide therapists (DHATs) working in
tribal health programs in the Medicaid program. The state and the
Swinomish Indian Tribal Community have petitioned the Ninth Circuit
Court of Appeals to hear an appeal on the rejection of the Washington
State Plan Amendment. Medicaid reimbursement for DHATs is critical to
supporting and expanding dental services in tribal communities. We
trust that this matter is resolved soon so tribal health programs in
Washington can be reimbursed at the OMB encounter rate for these
critical services.
health resources and services administration (hrsa)
Provider Relief Fund Uninsured Program. The COVID-19 relief
legislation packages exclude Indian Health Care Providers from
receiving reimbursement from the Provider Relief Fund Uninsured
Programs for uninsured American Indian/Alaska Native people. This
exclusion is inconsistent with national Indian policy to elevate the
health status of AI/AN people by making all resources available to the
Indian health system. We request that the Subcommittee support the
following legislative language to address this issue:
SEC. XXX. CLARIFICATION REGARDING INDIANS AND UNINSURED INDIVIDUALS.
Subsection (ss) of section 1902 of the Social Security Act (42
U.S.C. 1396a), as added by section 6004(a)(3)(C) of the Families First
Coronavirus Response Act, is amended--(ss) in paragraph (2), by
inserting ``(except Indians (as defined in section 4 of the Indian
Health Care Improvement Act (25 U.S.C. 1603)) who receive health
services funded by the Indian Health Service, shall not be treated as
enrolled in a Federal health care program for purposes of this
paragraph)'' before the period at the end.
Provider Shortages and Needs. The Broken Promises Report, National
Tribal Behavioral Health Agenda, National Tribal Budget Formulation
Workgroup Recommendations for 2021, and the IHS Strategic Plan all
detail how culturally responsive care is critical for the health and
well-being of AI/AN people. There are significant vacancy rates and
challenges in filling vacancies at I/T/U facilities. Some of these
challenges include: the rural location of tribal facilities, lower
salaries, lack of incentives, and insufficient housing for providers.
For these reasons, we strongly recommend that the Committee support
funding for HRSA, as follows:
--Increase Tribal Set-Aside for Loan Forgiveness Program. Increase
tribal set-asides for loan forgiveness and include mid-level
health care professionals such as Community Health Aide Program
providers in the program.
--Support Community Health Aide Program Expansion. As IHS is
expanding the CHAP program in the lower 48, HRSA must create
new funding opportunities that support national CHAP expansion.
We recommend $60 million to support CHAP education programs and
other implementation activities.
national institutes of health
The Native American Research Centers for Health (NARCH) national
program has catalyzed multiple tribal-academic partnerships that have
resulted in many successful research projects and training
opportunities for AI/AN people interested in science and health of AI/
AN people. The NPAIHB's NARCH programs have supported and developed
countless Native researchers through this program. We request that
NARCH be a congressionally mandated funding priority as it supports
tribal health research with the development of tribal health leaders to
design and implement research that is responsive to tribal needs. In FY
2022, we recommend increased funding for the NARCH program to $20
million and request that 30% of the funding be directed to enhance AI/
AN workforce development in parity with priorities of NIH institutes
and centers.
Thank you for this opportunity to provide recommendations to the
Committee on FY 2022 funding for HHS. We invite you to visit Portland
Area Tribes to learn more about the communities, utilization of HHS
funding, and health care needs in our Area. We look forward to working
with the Subcommittee on our requests.\1\
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\1\ For more information, please contact Candice Jimenez,
[email protected].
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______
Prepared Statement of the Nursing Community Coalition
As the nation continues to address COVID-19, we recognize how
crucial federal investments for the nursing workforce and the nursing
pipeline are to our patients and the health of our nation. Given these
realities, the Nursing Community Coalition (NCC) respectfully requests
that Congress continues robust and bold investment in nursing
workforce, education, and research in Fiscal Year (FY) 2022 by
supporting at least $530 million for the Nursing Workforce Development
programs (authorized under Title VIII of the Public Health Service Act
[42 U.S.C. 296 et seq.] and administered by HRSA), a doubling of Title
VIII funding, and at least $199.755 million for the National Institute
of Nursing Research (NINR), which aligns with the President's FY 2022
budget and is one of the 27 Institutes and Centers within NIH.
The Nursing Community Coalition is comprised of 63 national nursing
organizations who work together to advance health care issues that
impact education, research, practice, and regulation. Collectively, the
NCC represents Registered Nurses (RNs), Advanced Practice Registered
Nurses (APRNs),\1\ nurse leaders, students, faculty, and researchers,
as well as other nurses with advanced degrees. With more than four
million nurses throughout the country, the NCC is committed to
advancing the health of our nation through the nursing lens.\2\ The
nursing workforce is involved at every point of care, which is
exemplified by nurses' heroic work during the COVID-19 pandemic.
Together, we reiterate the bold request for increased funding for Title
VIII Nursing Workforce Development programs and NINR, especially during
these unprecedented times.
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\1\ APRNs include certified nurse-midwives (CNMs), certified
registered nurse anesthetists (CRNAs), clinical nurse specialists
(CNSs) and nurse practitioners (NPs).
\2\ National Council of State Boards of Nursing. (2021). Active RN
Licenses: A profile of nursing licensure in the U.S. as of February 9,
2021. Retrieved from: https://www.ncsbn.org/6161.htm.
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Providing Care to All Americans Through the Nursing Lens
As we continue to confront today's health care challenges and plan
for tomorrow, increased federal resources for our nation's current and
future nurses are even more imperative. Title VIII programs are
instrumental in bolstering and sustaining the nation's diverse nursing
pipeline by addressing all aspects of nursing workforce demand. In
fact, the Bureau of Labor Statistics projected that by 2029 demand for
RNs would increase 7%, illustrating an employment change of 221,900
nurses.\3\ Further, the demand for most APRNs is expected to grow by
45%.\4\ This is just one example on why continued and elevated
investments in Title VIII Nursing Workforce Development Programs in FY
2022 is essential and will help nurses and nursing students have the
resources to tackle our nation's health care needs, remain on the
frontlines of the COVID-19 pandemic, assist with the distribution and
administration of the vaccine, and be prepared for the public health
challenges of the future.
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\3\ U.S. Bureau of Labor Statistics. (20). Occupational Outlook
Handbook-Registered Nurses. Retrieved from: https://www.bls.gov/ooh/
healthcare/registered-nurses.htm.
\4\ U.S. Bureau of Labor Statistics. (2021). Occupational Outlook
Handbook-Nurse Anesthetists, Nurse Midwives, and Nurse Practitioners.
Retrieved from: https://www.bls.gov/ooh/healthcare/nurse-anesthetists-
nurse-midwives-and-nurse-practitioners.htm.
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Funding for Title VIII is essential, but especially crucial during
public health emergencies as these programs connect patients with high-
quality nursing care in community health centers, hospitals, long-term
care facilities, local and state health departments, schools,
workplaces, and patients' homes. A prime example of this is the Title
VIII Advanced Nursing Education (ANE) programs. ANE programs support
APRN students and nurses to practice on the frontlines and in rural and
underserved areas throughout the country. In Academic Year 2019-2020,
ANE programs supported more than 8,200 students.\5\ Of these students
directly supported by the Advanced Nursing Education Workforce (ANEW)
program, 75 percent had clinical training sites in primary care
settings, while 73 percent of Nurse Anesthetist Trainee (NAT)
recipients were trained in medically underserved areas.\6\
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\5\ Department of Health and Human Services Fiscal Year 2022 Health
Resources and Services Administration Justification of Estimates for
Appropriations Committees. Pages 153-158. Retrieved from: https://
www.hrsa.gov/sites/default/files/hrsa/about/budget/budget-
justification-fy2022.pdf.
\6\ Department of Health and Human Services Fiscal Year 2022 Health
Resources and Services Administration Justification of Estimates for
Appropriations Committees. Pages 153-155. Retrieved from: https://
www.hrsa.gov/sites/default/files/hrsa/about/budget/budget-
justification-fy2022.pdf.
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Together, Title VIII Nursing Workforce Development programs serve a
vital need and help to ensure that we have a robust nursing workforce
that is prepared to respond to public health threats and ensure the
health and safety of all Americans. The Nursing Community Coalition
respectfully requests at least $530 million for the Title VIII Nursing
Workforce Development programs in FY 2022.
Improving Patient Care Through Scientific Research and Innovation
For more than thirty years, scientific endeavors funded at the
National Institute of Nursing Research (NINR) have been essential to
advancing the health of individuals, families, and communities.
Rigorous inquiry and research are indispensable when responding to the
ever-changing healthcare landscape and healthcare emergencies, such as
COVID-19. From precision genomics to palliative care and wellness
research to patient self-management, NINR has been at the forefront of
evidence driven research to improve care.\7\ It is imperative that we
continue to support this necessary scientific research, which is why
the Nursing Community Coalition respectfully requests at least $199.755
million for the NINR in FY 2022.
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\7\ National Institutes of Health, National Institute of Nursing
Research. The NINR Strategic Plan: Advancing Science, Improving Lives.
Pages 4, 10 Retrieved from https://www.ninr.nih.gov/sites/
www.ninr.nih.gov/files/NINR_StratPlan2016_reduced.pdf.
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Now, more than ever, it is vital that we have the resources to meet
today's public health challenges, such as COVID-19. Investing in Title
VIII Nursing Workforce Development programs and NINR are essential to
meeting that need. By providing bold funding for Title VIII and NINR,
Congress can continue to reinforce and strengthen the foundational care
nurses provide daily in communities across the country. Thank you for
your support of these crucial programs.
60 Members of the Nursing Community Coalition Submitting this Testimony
Academy of Medical-Surgical Nurses
American Academy of Ambulatory Care Nursing
Academy of Neonatal Nursing
American Academy of Nursing
American Association of Colleges of Nursing
American Association of Critical-Care Nurses
American Association of Heart Failure Nurses
American Association of Neuroscience Nurses
American Association of Nurse Anesthetists
American Association of Nurse Practitioners
American Association of Post-Acute Care Nursing
American College of Nurse-Midwives
American Nephrology Nurses Association
American Nurses Association
American Nursing Informatics Association
American Organization for Nursing Leadership
American Pediatric Surgical Nurses Association, Inc.
American Public Health Association, Public Health Nursing Section
American Psychiatric Nurses Association
American Society for Pain Management Nursing
American Society of PeriAnesthesia Nurses
Association for Radiologic and Imaging Nursing
Association of Community Health Nursing Educators
Association of Nurses in AIDS Care
Association of Pediatric Hematology/Oncology Nurses
Association of periOperative Registered Nurses
Association of Public Health Nurses
Association of Rehabilitation Nurses
Association of Veterans Affairs Nurse Anesthetists
Association of Women's Health, Obstetric and Neonatal Nurses
Chi Eta Phi Sorority, Incorporated
Commissioned Officers Association of the U.S. Public Health Service
Dermatology Nurses' Association
Emergency Nurses Association
Friends of the National Institute of Nursing Research
Gerontological Advanced Practice Nurses Association
Hospice and Palliative Nurses Association
Infusion Nurses Society
International Association of Forensic Nurses
International Society of Psychiatric-Mental Health Nurses
National Association of Clinical Nurse Specialists
National Association of Hispanic Nurses
National Association of Neonatal Nurse Practitioners
National Association of Neonatal Nurses
National Association of Nurse Practitioners in Women's Health
National Association of Pediatric Nurse Practitioners
National Association of School Nurses
National Black Nurses Association
National Council of State Boards of Nursing
National League for Nursing
National Nurse-Led Care Consortium
National Organization of Nurse Practitioner Faculties
Nurses Organization of Veterans Affairs
Oncology Nursing Society
Organization for Associate Degree Nursing
Pediatric Endocrinology Nursing Society
Preventive Cardiovascular Nurses Association
Society of Pediatric Nurses
Society of Urologic Nurses and Associates
Wound, Ostomy, and Continence Nurses Society
[This statement was submitted by Rachel Stevenson, Executive
Director, Nursing Community Coalition.]
______
Prepared Statement of the Nutrition & Medical Foods Coalition
summary of fiscal year 2022 appropriations recommendations
_______________________________________________________________________
--NMFC joins the research and patient advocacy community in
requesting $46.1 billion in discretionary funding for the
National Institutes of Health (NIH), an increase of $3.2
billion over FY 2021.
--Further, NMFC requests proportionate increases for all NIH
Institutes and Centers, including the Office of the
Director (which now houses the Office of Nutrition
Research), to reflect the vast array of applications for
medical foods and nutrition to address a variety of health
conditions through ongoing scientific inquiry and
advancement.
--The Coalition joins the broader public health community in
requesting $10 billion in overall funding for the Centers for
Disease Control and Prevention (CDC) to reinvigorate meaningful
professional education, public awareness, and public health
activities.
--The community encourages ongoing outreach through the annual
appropriations process to address systemic (and often
arbitrary) barriers that obstruct proper patient access to
medical foods including directing HHS and FDA to administer
public health programs and regulations where medical foods are
classified as prescription medical products intended for the
dietary management of unmet needs.
_______________________________________________________________________
Chairwoman Murray, Ranking Member Blunt, and distinguished Members
of the Subcommittee: thank you for the opportunity to submit testimony
on behalf of the Nutrition and Medical Foods Coalition (NMFC). We
strongly support emerging efforts to modernize the medical foods
category and enhance patient access, such as establishing the Office of
Nutrition Research within the Office of the NIH Director, and the 2018
National Academies workshop on distinct nutritional requirements. As
you work with your colleagues on appropriations for FY 2022, please
continue to invest in medical research and public health programs to
improve coverage and access for patients in need of medical foods.
Medical foods provide important clinical product alternatives when
drugs are not effective or well tolerated. Consistent with the
establishment of the medical foods regulatory category in the Orphan
Drug Act amendments of 1988, increasing medical research and expanding
the reimbursement of medical food products from the hospital-only
environment to retail pharmacies through Medicare, Medicaid, TRICARE,
and medical insurance for federal employees, would enable the use of
medical foods to address unmet medical needs and support scientific
innovation providing clinical options to physicians as they work to
manage national public health issues such as the Opioid Crisis, genetic
disorders, and the increasing incidences of chronic diseases and
conditions associated with aging like depression, osteoarthritis, IBS,
and Alzheimer's. This could, in-turn, manage disease progression and
lower national healthcare costs. Thank you for your time and please
consider the Coalition a resource.
about the coalition
NMFC is a collaborative, multi-stakeholder effort to promote and
advance proper use of safe and effective medical foods. Medical foods
occupy a unique niche in healthcare and are used to manage many rare
and chronic conditions for patients with unmet medical needs. NMFC is
committed to educating policymakers and the general public about the
role of medical foods in the healthcare ecosystem, while advancing an
agenda focused on increasing medical research, improving regulation and
oversight, and increasing access through appropriate insurance coverage
and reimbursement.
The Coalition actively supports legislative efforts to address
coverage and access, such as the Patient Access to Medical Foods Act
(H.R. 56), Medical Nutrition Equity Act, and similar legislation. In
this regard, NMFC calls on legislators to ensure that any updates to
medical foods coverage:
--Maintains the integrity of the current (aforementioned) definition
for the category.
--Does not arbitrarily carve out specific patient communities for
coverage while leaving other communities (including patients
without digestive or metabolic disorders) behind.
--Provides comprehensive coverage and adequate access to facilitate
reasonable outpatient access to medical foods so there is
health insurance pharmacy reimbursement in addition to
historical access that exists through hospitals.
Moving forward, federal medical research and public health programs
can play a key role in informing coverage and access updates while
educating patients and providers about innovative (often cost-
effective) healthcare options.
about medical foods
As defined by the Orphan Drug Act of 1988, a medical food is, ``a
food which is formulated to be consumed or administered enterally under
the supervision of a physician, and which is intended for the specific
dietary management of a disease or condition for which distinctive
nutritional requirements, based on recognized scientific principles,
are established by medical evaluation.''
Currently, patients in need of medical foods face significant
coverage and access barriers often stemming from a lack of awareness of
these products and their unique role in the healthcare system.
Reimbursement access is grounded in federal and private insurance
pharmacy benefit plans often categorically denying coverage of medical
foods through pharmacies as a policy matter while they generally
reimburse under medical benefits in hospitals. This often results in
patients being denied access to nutritional therapies which are
necessary alternatives to drugs that are ineffective or not well
tolerated. The Food and Drug Administration (FDA) regularly intervenes
to provide guidance on medical foods, including through a recent
episode where products were mislabeled as Over-The-Counter on massive
level, but these interventions are inconsistent at best and often do
not resolve underlying coverage issues.
perspective of cindy steinberg, us pain foundation
One example of important innovation in medical foods is in the area
of chronic pain, a highly prevalent yet challenging condition to treat.
The CDC has reported that 19.6 million Americans live with high-impact
chronic pain resulting from a multitude of serious diseases, conditions
and injuries that affects their ability to function on a daily basis.
Indeed, chronic pain is the number one cause of disability in the US
and globally.
There are few truly effective treatment options and most of these
come with difficult side effects, safety concerns or other risks.
Opioids do help some with severe pain but carry significant risks when
diverted to those with substance abuse disorder. Non-steroidal anti-
inflammatory (NSAIDs) medications are widely prescribed but, due to
risks of heart attack, stroke and gastrointestinal bleeding are
contraindicated for many, especially those with multiple chronic
conditions. Acetaminophen has limitations due to insufficient pain
relief and liver damage at doses high enough to alleviate serious pain
for some. Moreover, federal agencies and the broader stakeholder
community have been actively working over recent years to identify non-
opioid options for pain management.
Medical foods have been found to fill a need for pain relief for
individuals with certain chronic conditions such as osteoarthritis.
Medical foods are generally safe products that can address conditions
such as pain without causing other side effects. Distinct from both
drugs and supplements, medical foods must be used under the supervision
of a medical professional. Lack of awareness about medical foods as an
emerging, cost-effective treatment option for certain pain conditions
amongst healthcare providers and insurers have limited their use.
Improving research and coverage for medical foods would offer patients
another option, particularly those with multiple chronic conditions and
unmet medical needs.
Recommendation:
Please include timely committee recommendations on medical foods
research at NIH, like the example below, to sustain progress in this
area. Please also work with your colleagues to engage HHS in a
productive dialogue and otherwise seek out opportunities to improve
coverage and access for patients in need of reliable access to medical
foods. Thank you for your time and for your consideration of our
request.
recommended report language
national institutes of health
office of the director
Office of Nutrition Research [ONR].--The Committee applauds NIH for
recent efforts to move the Office of Nutrition Research to the Office
of the Director in recognition of the fact that scientific progress in
nutrition and medical foods now has applications to a variety of health
topics and conditions beyond diet and metabolism. NIH is encouraged to
continue to advance cross-cutting research through ONR, including
timely applications for a variety of conditions, such as innovative
strategies and alternative therapeutic products for pain management.
[This statement was submitted by P. Keith Daigle, Acting Director,
Nutrition & Medical Foods Coalition.]
______
Prepared Statement of One Voice Against Cancer
One Voice Against Cancer (OVAC) is a broad coalition of public
interest groups representing millions of cancer patients, researchers,
providers, survivors, and their families, delivering a unified message
to Congress and the White House on the need for increased funding for
cancer research and prevention priorities.
2021 is the 50th Anniversary of the National Cancer Act and it
provides a unique opportunity to renew the country's commitment and
bring new urgency to the fight against cancer. Although we have made
much progress against cancer in the past half-century, more funding is
needed to meet the overwhelming demand for research grants at the
National Cancer Institute (NCI), address cancer health disparities, and
mitigate the impacts of COVID-19 on cancer research, clinical trials,
and patient screenings and treatment. For fiscal year (FY) 2022, we are
asking that Congress fund the National Institutes of Health (NIH) at
$46.111 billion, including $7.6 billion for the NCI. We are also asking
that the Centers for Disease Control and Prevention's (CDC) Division of
Cancer Prevention and Control (DCPC) receive $559 million.
There is much to celebrate in the fight against the hundreds of
diseases we call ``cancer.'' The cancer death rate rose during most of
the 20th century, but federal investments in cancer research and
prevention have resulted in a continuous decline in the cancer death
rate since its peak in 1991. From 1991 to 2018, the cancer death rate
fell 31 percent. However, cancer is still the second most common cause
of death in men and women in the U.S. In 2021, almost 1.9 million new
cancer cases will be diagnosed, and more than 600,000 people will die
from cancer. Approximately $183 billion was spent in the U.S. on cancer
related health care in 2015, and this amount is projected to grow to
$246 billion by 2030-an increase of 34 percent.
Cancer is a disease that affects everyone, but it doesn't affect
everyone equally. A close look at cancer incidence and mortality
statistics reveals that certain groups, such as African Americans,
Asian Americans, Hispanics/Latinos, Native Americans, Alaska Natives,
Native Hawaiians/Pacific Islanders, and rural populations are more
likely than the general population to suffer from cancer and its
associated effects, including premature death. For instance, the death
rate for Black men with prostate cancer is more than double that of men
in every other population. Black women have a 40 percent higher breast
cancer death rate than white women, even though their diagnosis rates
are slightly lower.
There are still some cancers for which survival rates are dismally
low with few, if any, effective treatments. In 2021, approximately 44
percent of patients will be diagnosed with a cancer that has a five-
year survival rate below 50 percent. Research is critical so we can
develop additional treatments and tools to ensure more Americans
survive a cancer diagnosis.
Additionally, the NCI reports that we may see a rise in cancer
mortality rates for the first time in almost 30 years because of the
impacts from COVID-19. The COVID-19 pandemic has led to reduced access
to care for cancer patients, including delays in cancer screening,
diagnosis, and treatment. These delays will likely lead to a rise in
late-stage diagnoses and cancer deaths in the years to come.
For the last 50 years, every major medical breakthrough in cancer
can be traced back to the NIH and NCI. We know that investment in
research at the NIH and NCI leads to lives saved. Additionally, more
than 80 percent of federal funding for the NIH and NCI is spent on
biomedical research projects at research facilities across the country.
In FY 2020, the NIH provided over $34.6 billion in extramural research
to scientists in all 50 states and the District of Columbia. NIH
research funding also supported more than 536,000 jobs and more than
$91 billion in economic activity last year.
COVID-19 and Cancer Research and Clinical Trials:
The Committee should be aware of the ongoing impact of COVID-19 on
the cancer research ecosystem, including clinical trials. Thousands of
researchers working on new discoveries that may one day alter the way
we treat cancer had their projects disrupted, leading to increased
costs and in some cases, having to restart research projects, losing
data and productivity in the process.
COVID-19 has had serious consequences for cancer clinical trials,
which play a pivotal role in advancing cancer care and treatment. The
results of clinical trials and the broader drug development process can
take years to realize, meaning that without aggressive measures to
mitigate the impact, the full effect of these disruptions on
therapeutic innovation in cancer care is likely to be felt for years to
come. Not only are cancer clinical trials critical in the over-all
research and progress against the disease, for individual cancer
patients, clinical trials often provide the best, and sometimes only,
treatment option available.
We therefore urge Congress to provide the NIH with at least $10
billion to restore the research ecosystem so we can continue to make
progress in the fight against cancer and other diseases. We hope that
members of the Subcommittee can work with their colleagues to ensure
this issue is addressed outside the usual appropriations process.
ARPA-H:
We understand that President Biden has called for the creation of
an Advanced Research Projects Agency-Health (ARPA-H) as a key component
to ``drive transformational innovation in health research'' to deliver
cures for cancer and other diseases. Based upon available information,
the initiative is likely to have twin focus areas: transformation of
research and speeding application and implementation of breakthroughs
in health care, where the current model has failed to deliver medical
advancements. The President has spoken about the initiative and has
included a $6.5 billion proposal in the his FY2022 budget, but few
other details have emerged.
We in the cancer community are excited by a new initiative that
focuses separate and additional resources on the development of new
diagnostics, treatments, and even cures for cancer. However, we also
know that clinical advances for patients have to be built on a broad
foundation of basic scientific understanding.
Therefore, OVAC recommends that funding for ARPA-H remain separate
from the established research enterprise and that Congress works to
ensure that base funding for cancer research at the NCI is increased at
a sustained, appropriate rate that ensures the pace of discovery is
maintained.
OVAC Priorities for Fiscal Year 2022:
The NCI is currently experiencing a demand for research funding
that is far beyond that of any other Institute or Center (IC). Between
FY 2013 and FY 2019, the most recent year for which data are available,
the number of Research Project Grant (R01) applications to NCI rose by
50.6 percent. For all other ICs during that time, the number of R01
applications rose by just 5.6 percent.
As a result of this extraordinary demand from the scientific
community, the RPG success rate at NCI dropped from 13.7 percent in FY
2013 to 11.6 percent in FY 2019. This is a situation unique to NCI, at
a time when cancer researchers are making historic advances in new
treatments and therapies. The overall success rate for NIH during that
same period rose from 16.8 percent to 21.2 percent.
Thanks to bipartisan, bicameral leadership, Congress has increased
funding for NIH by $12.9 billion over the past six years. We are
especially grateful that Congress has highlighted the need for
dedicated funding to address the precipitous decline in the success
rate for R01 applications at NCI. Significant, sustained funding
increases for NCI are essential to raising the R01 success rate and
ensuring progress in the fight against cancer continues.
Therefore, OVAC recommends at least $46.111 billion for NIH in FY
2022, a $3.177 billion increase over the comparable FY 2021 funding
level, which would allow the NIH's base budget to keep pace with the
biomedical research and development price index and provide meaningful
growth of 5 percent. For NCI, we recommend $7.609 billion, the amount
proposed by NCI in its FY 2022 professional judgment budget.
Preventing cancer is also critically important. About half of the
over 600,000 cancer deaths that will occur this year could be averted
through the application of existing cancer control interventions. The
CDC's DCPC provides key resources to states and communities to prevent
cancer by ensuring that at-risk, low-income communities have access to
vital cancer prevention programs.
COVID-19's impact on screening and the early-detection of cancer
will exacerbate current barriers to cancer prevention and early
detection strategies, potentially increasing disparities in overall
cancer outcomes. Additionally, addressing the backlog of cancer
screenings for those without adequate health coverage will place a new
burden on existing cancer screening programs, which have long been
underfunded. CDC's programs help ensure that Americans have options for
cancer screening regardless of income or insurance status. Increased
investment in the equitable application of existing cancer control
interventions as spearheaded by CDC's DCPC will accelerate progress in
the fight against cancer. For this reason, OVAC recommends $559 million
overall for DCPC, an increase of $173.1 million over the FY 2021 level.
Once again, thank you for your continued leadership on funding
issues important in the fight against cancer. Funding for cancer
research and prevention, survivorship, and must continue to be top
budget priorities in order to increase the pace of progress in the
fight against cancer.
Below please find an overview of OVAC's program level requests in
the Labor-HHS bill:
National Institutes of Health (NIH)--$46.111 billion, including:
--National Cancer Institute (NCI): $7.609 billion
--National Institute on Minority Health and Health Disparities
(NIMHD): $419.8 million
--National Institute on Nursing Research (NINR): $187.9 million
Centers for Disease Control and Prevention (CDC) Cancer Programs--
$559 million, including:
--National Comprehensive Cancer Control Program: $50 million
--National Program of Cancer Registries: $70 million
--National Breast and Cervical Cancer Early Detection Program: $275
million
--Colorectal Cancer Control Program: $70 million
--National Skin Cancer Prevention Education Program: $5 million
--Prostate Cancer Awareness Campaign: $35 million
--Ovarian Cancer Control Initiative: $13 million
--Gynecologic Cancer and Education and Awareness (Johanna's Law): $15
million
--Cancer Survivorship Resource Center: $900,000
Health Resources and Services Administration (HRSA)
--Title VIII Nursing Programs: $270 million
______
Prepared Statement of the Pandemic Action Network
On behalf of the Pandemic Action Network--a network of over 100
organizations that work together to drive collective action to help
bring an end to COVID-19 and ensure the world is prepared for the next
pandemic--I am pleased to offer testimony for Fiscal Year 2022 Labor,
Health, and Human Services Appropriations.
To ensure the United States heeds the lessons learned from COVID-19
and helps ensure the world sustainably prioritizes and invests in
pandemic preparedness, we respectfully urge you to increase funding to
the U.S. Centers for Disease Control and Prevention (CDC) overall and
bolster its critical role in promoting global health security; support
permanent, dedicated funding for the Biological Advanced Research and
Development Authority's (BARDA) work in emerging infectious diseases;
and ensure the U.S. government contributes to global R&D efforts by
strengthening the Coalition for Preparedness Innovations (CEPI).
Specifically, Pandemic Action Network calls on the Committee to
prioritize the following investments for FY22:
--No less than $456.4m for CDC's Center for Global Health Division of
Global Public Health Protection and $226m for the Global
Immunization Division;
--No less than $10m for CDC's Global Water, Sanitation & Hygiene
program;
--No less than $735m for CDC's Center for Emerging Zoonotic and
Infectious Diseases;
--No less than $300m in CDC's Infectious Disease Rapid Response Fund
--No less than $300m for BARDA's work on Emerging Infectious Diseases
--No less than $200 million support US investment in and partnership
with the Coalition for Epidemic Preparedness Innovation (CEPI),
in collaboration with BARDA
The COVID-19 pandemic has laid bare the grave health and socio-
economic consequences of repeated failures to prioritize and invest in
health security and pandemic preparedness both at home and abroad. The
pandemic has already cost over 580,000 lives in the United States and
3.4 million around the world. The International Monetary Fund projects
it will cost the global economy at least $22 trillion. While
vaccination efforts have begun to dramatically reduce COVID-19
transmission in the U.S., the pandemic continues to spread globally as
a majority of the world's population still lacks access to vaccines and
other lifesaving tools and new variants of the virus continue to
emerge. Until the virus is controlled around the world, Americans will
not be safe and our domestic recovery will continue to stall.
The COVID-19 pandemic was an avoidable disaster. Partners in our
network and infectious disease experts had been warning for decades of
the threat of a fast-moving respiratory virus pandemic. Yet a
persistent culture of panic and neglect, has prevented forward-looking
and long-term investments in global health security. U.S. leadership
and international cooperation is essential both to end this pandemic
and to prepare for the next one. CDC, BARDA, and other agencies across
the Department of Health and Human Services have a critical role to
play to keep both Americans and the world safe--but they must be
appropriately, and sustainably, resourced. The Pandemic Action Network
urges this committee and Congress to break this dangerous cycle once
and for all and commit to increased--and sustained--investments in
pandemic preparedness in Fiscal Year 2022 and beyond.
CDC:
The CDC comprises an essential piece of the U.S. and global health
security architecture--by serving as the steward of U.S. public health
and by partnering with countries to build and maintain their capacities
to detect, prevent, and respond to emerging disease threats.
The Division of Global Public Health Protection (DGHP) works to
protect Americans from dangerous health threats around the world and
has been vital in the global fight against COVID-19. Graduates of its
Field Epidemiology Training Program, a program to train disease
detectives around the world, have been supporting COVID-19 responses in
their countries through disease detection and rapid response, as well
as data analysis, contact tracing, and community outreach. DGHP's
Global Rapid Response Team has deployed more than 500 deployments for a
total of nearly 16,000 person-days, to assist with COVID-19 emergency
response at home and abroad. In a world where pandemic threats are
growing in frequency, this critical work needs to be resourced and
upscaled.
Many other divisions and programs within CDC are also critical to
fighting deadly outbreaks and strengthening global health security,
including the Global Immunization Division of the Center for Global
Health, the Global Water, Sanitation & Hygiene program, the Center for
Emerging Zoonotic and Infectious Diseases, and the Infectious Disease
Rapid Response Fund. All have been routinely underfunded relative to
their vital roles in protecting American and global health and deserve
funding commensurate with their increasing demand and value.
BARDA:
BARDA has been playing an important and unmatched role in
accelerating the development of medical countermeasures for emerging
infectious diseases, including for Ebola, Zika, and pandemic influenza.
The authority partners with industry on late-stage research and
development, bridging the ``valley of death'' between clinical research
and product development to translate basic science into urgently needed
medical tools and technologies--where few entities operate.
Yet BARDA's work to combat COVID-19 and advance innovations for
other emerging and neglected infectious diseases has largely been
financed through emergency supplemental funding. This means that only
when a disease crisis strikes does BARDA get the go-ahead and funding
to advance countermeasures. Decades of research in health R&D laid the
groundwork for the accelerated COVID-19 vaccine development--and
humanity was lucky that we could build on progress in SARS and mRNA
platforms. Emergency, surge funding is not a viable solution for
pandemic prevention or preparedness: in many cases it is not even a
solution for pandemic response. Annual, targeted funding for emerging
infectious disease R&D will enable BARDA to work proactively to counter
infectious disease threats so that we are prepared, and not caught flat
footed when the next dangerous outbreak happens.
CEPI:
This Committee should also prioritize BARDA's partnership with
CEPI, which has played a critical role in the COVID-19 response.
Scientific partnership, collaboration, and resource sharing between
BARDA and CEPI is critical to leverage their respective strengths and
resources, and to promote the development of infectious diseases tools
that can be rapidly deployed in a diverse array of settings. The U.S.
should be a leading partner in supporting CEPI's new five-year plan of
action with an annual appropriation of at least $200 million.
Just as the U.S. military is routinely resourced and prepared to
fight a current war while getting ready for the next one, so too should
Congress ensure that our civilian health infrastructure is equipped to
fight this pandemic and prepare for the next one. We should commit the
funds necessary to deploy a robust global response to the evolving
COVID-19 pandemic while simultaneously make strong, sustainable, and
ultimately cost-effective investments in future pandemic preparedness
and prevention--lest we risk repeating the cycle of panic and neglect
that spawned this protracted global emergency. Additional and sustained
investments in CDC, BARDA, and CEPI are vital to America's health and
security and warrant Congress's strong and unwavering support.
______
Prepared Statement of PATH
This testimony is submitted by Jenny Blair on behalf of PATH, an
international nonprofit organization that drives transformative
innovation to save lives and improve health in low- and middle-income
countries. PATH is appreciative of the opportunity afforded by
Chairwoman Murray, Ranking Member Blunt, and members of the
Subcommittee on Labor, Health and Human Services, Education, and
Related Agencies to submit written testimony regarding fiscal year (FY)
2022 funding for global health programs within the US Department of
Health and Human Services (HHS). PATH acknowledges and appreciates the
strong leadership the Committee has shown in supporting HHS' work in
this area--especially given the current pandemic--and we recommend that
support continue. Therefore, we respectfully request that this
Subcommittee provide no less than the FY21 enacted level of $593
million to the Center for Global Heath (CGH) at the Center for Disease
Control and Prevention (CDC) to sustain programming and replenish funds
that have been diverted for the COVID-19 response that were intended
for global immunization, malaria, global health security, and research
and development (R&D). Within CGH, we specifically support increases
for CDC's Division of Global Health Protection, which should be
increased from $203.2 million to at least $456.4 million to bolster
capacity to prevent, detect, and rapidly respond to emerging diseases--
including the current COVID-19 pandemic--in low- and middle-income
countries. We also support an additional $300 million for the
Infectious Disease Rapid Response Fund, $30 million for CGH's Division
of Parasitic Diseases and Malaria, and $271.1 million for the Global
Immunization Division--of which $211.2 million should allocated to
polio eradication and $60 million for measles. This funding allows CDC
to save lives, reduce disease, prevent and detect future pandemics, and
improve health around the world.
The Vital Role of HHS in Global Health and Security
PATH applauds Congressional appropriators for the global health
funding that has been provided in four supplementals--the Coronavirus
Preparedness and Response Supplemental, the CARES Act, the Coronavirus
Response and Relief Supplemental Appropriations Act of 2021, and the
American Rescue Plan Act of 2021--over the last year. COVID-19 has
reached every country in the world, crippling economies, overwhelming
health care systems, filling hospitals, dwindling supplies, and
emptying public spaces. While we are beginning to see the end of the
pandemic here in the United States, countries such as India and Brazil
are still heavily impacted. With the potential for emergence of
vaccine-evading strains, COVID-19 will continue to threaten global
health security as long as it is uncontrolled anywhere in the world.
Investments that help contain diseases at the source are some of
the most effective and important the US government can make. US
investments through the CDC have been used to train epidemiologists,
engage affected communities, improve disease detection and tracking
systems, build Emergency Operations Centers (EOCs), and upgrade
laboratories. Such efforts have allowed partner countries to greatly
shorten their response times to outbreaks and epidemics--for example,
enabling Cameroon to shorten its response timeline from 8 weeks to 24
hours. Many of the US's partner countries have deployed these systems
for their COVID-19 response.
The ongoing threat that COVID-19 and other infectious diseases pose
to the health, economic security, and national security of the United
States demands dedicated and steady funding for global health security.
We must invest not only to end the current pandemic, but also to ensure
that we are better prepared for the next one.
Protecting the US Through Leadership in Global Health Research and
Development
The ongoing COVID-19 pandemic is a clear call for investment in
America's capacity to rapidly develop and deploy new technologies that
can prevent, detect, and treat emerging global health threats. The US
leads the world in R&D for tools that solve some of humanity's most
pressing health problems. The annual G-Finder report from Policy Cures
Research estimates that in 2018, the US contributed $1.718 billion
through the National Institutes of Health (NIH) and $30 million through
CDC toward the development of global health products.
In the current pandemic, support through NIH and the Biomedical
Advanced Research and Development Authority (BARDA) helped speed the
development and manufacturing of vaccines to prevent COVID-19,
including through partnerships Janssen Research & Development, part of
Johnson & Johnson, as well as Moderna. Under Operation Warp Speed,
BARDA pivoted existing programs for pandemic influenza and other
threats to accelerate the development of new vaccines, therapeutics,
and diagnostic tests.
However, as a nation we have failed to sustain investment in a
suite of technologies that will help us respond to the disease threats
most likely to impact Americans and populations around the globe. For
example, development of a promising SARS vaccine was halted in 2016 due
to lack of funding--only to be re-started after the spread of COVID-19.
Congress must ensure that the US is making sustained smart investments
for just-in-case development and just-in-time delivery of the tools we
will need for the most likely threats to human health.
Today more than ever, the US is at the forefront of global health
innovation because of long-term investment in NIH, CDC, and BARDA. To
accelerate progress toward lifesaving tools for a range of health
threats, we call for: maintaining robust funding for NIH and
particularly for the National Institute of Allergy and Infectious
Diseases (NIAID) and the Fogarty International Center; providing
funding to match CDC's increased responsibilities in global health and
security for the Center for Global Health and the National Center for
Emerging Zoonotic and Infectious Diseases; and supporting BARDA's work
in emerging infectious diseases.
As a complement to continued investment in BARDA and NIH, the US
should invest in the Coalition for Epidemic Preparedness Innovations
(CEPI) which is working to advance at least twelve COVID-19 vaccine
candidates. Investment in CEPI would allow the US to leverage funding
from other global donors and ensure the US can influence the impact and
outcome of CEPI's efforts. A US contribution to CEPI would leverage the
contributions of other donors to increase overall pandemic preparedness
and response effectiveness, including the potential to help increase
the effectiveness of vaccines already being used in the United States.
Successful implementation of these components requires urgent
coordination across agencies and strategic investments. Congress should
monitor progress on investments in emerging technologies and medical
countermeasures, as well as the integration of R&D into federal
planning including facilitating policies and incentives across
interagency R&D efforts.
Immunization Programs During COVID-19 and Beyond
HHS is also achieving complementary global health and security
goals through investment in immunization, with most vaccine delivery
activities overseen by CDC's Global Immunization Division. Vaccines are
among the most high-impact and cost-effective tools available today to
combat infectious disease threats; many vaccine-preventable diseases
were once global pandemics much like COVID-19. This pandemic is a stark
reminder of how fast an outbreak can spread without a vaccine to
protect us. Thanks to immunization, outbreaks of childhood diseases
such as polio, measles, diphtheria, and pertussis are preventable, and
communities are protected from some of the most infectious and lethal
pathogens.
Immunization programs prevent an estimated 2.5 million deaths each
year among children under the age of five worldwide; these programs
also bolster local health systems and enable better disease detection.
However, the COVID-19 pandemic has severely disrupted global
immunization programs and continues to threaten achievement of critical
global goals, such as polio eradication. Of the 129 countries able to
report routine immunization data at the outset of the pandemic last
year, over half reported moderate to total disruption of immunization
services. Of the 26 countries that were forced to suspend measles
immunization campaigns due to the pandemic, 18 reported measles
outbreaks by July of last year, according to data available in November
2020. Suspended campaigns put 94 million people at risk of missing
measles vaccinations in 2020. The Global Measles and Rubella Laboratory
Network (M&RI), for example, has been repurposed to provide laboratory
space, equipment, staff, and reagents for COVID-19 diagnostic testing,
and measles immunization staff supported by M&RI are being called on to
support COVID-19 responses in many vulnerable countries. These same
systems and infrastructure will be essential to ensuring COVID-19
vaccines are distributed equitably.
Even before the COVID-19 pandemic, vaccines for measles, polio, and
other diseases were out of reach, on an annual basis, for 20 million
children under the age of one. Worldwide, more than 10 million children
below the age of one do not receive any vaccines at all, many of whom
live in countries with weak health systems. Given these difficulties,
the disruption to immunization programs caused by COVID-19 could leave
pathways open to disastrous outbreaks in 2020 and future years and will
increase imported cases of measles and other vaccine preventable
diseases into the US. As health care continues to be disrupted
globally, maintaining strong US support for global vaccination
efforts--including key goals such as polio eradication, which we are on
the brink of achieving--is critical to preventing needless deaths.
Fighting to Eliminate Malaria
The CDC plays a critical role in the fight against malaria, as co-
implementer of the President's Malaria Initiative (PMI)--alongside the
US Agency for International Development--as well as through its
Parasitic Diseases and Malaria program. These programs provide crucial
technical assistance, with a focus on monitoring, evaluation, and
surveillance, as well as operational and implementation research,
including serving as an evaluation partner in the large-scale pilot
implementation of the RTS,S malaria vaccine in Kenya (one of three
African countries involved). Malaria prevention and treatment programs
have prevented more than seven million deaths globally since 2000.
Sustained US commitment made this progress possible.
The World Health Organization estimates that nearly half the
world's population lives in areas at risk of malaria-there were an
estimated 229 million cases and 409,000 deaths from the disease in 2019
alone. Disruptions of essential health services due to the COVID-19
pandemic are having a catastrophic impact on the most vulnerable
communities worldwide, threatening our progress against malaria.
According to the Global Fund, in Africa malaria diagnosis and treatment
has fallen roughly 15 percent during the pandemic and more than 20
percent of facilities have reported stockouts of medicines for treating
children under five. In Asia, diagnosis and treatment has fallen almost
60 percent due to COVID-19, and 37 percent of facilities have reported
COVID-19 infections amongst their health workers.
To reduce the pressure that COVID-19 is exerting on health systems,
it is critical that we continue to deliver malaria interventions at the
community level. As PMI has expanded, CDC's mandate has grown, but its
budget for malaria has remained stagnant. In FY 2022, Congress should
fully fund PMI and increase funding for the CDC Division of Parasitic
Diseases and Malaria (DPDM) program from $26 million to $30 million, to
better track, treat, and test for malaria, and to ensure these services
continue in the midst of a global health crisis.
An Investment in Health, at Home and Around the World
With strong funding for global health programs within HHS, the
department will be able to improve access to proven health
interventions in the communities where they are needed most, as well as
respond to the ongoing threat of COVID-19. By fully funding global
health and BARDA accounts, the US can prevent the further spread of
disease, protect the health of Americans, and minimize the impact of
COVID-19 on vulnerable populations worldwide.
[This statement was submitted by Jenny Blair, Manager, US & Global
Policy and Advocacy, PATH.]
______
Prepared Statement of Patient Services, Inc.
summary of fiscal year 2022 appropriations recommendations
_______________________________________________________________________
PSI joins the broader patient advocacy community in requesting:
--$46.1 billion in discretionary funding for the National Institutes
of Health (NIH), an increase of $3.2 billion over FY 2021.
--Please provide proportional funding increases for the various NIH
Institutes and Centers to expand and advance condition-
specific research portfolios.
--$10 billion in overall funding for the Centers for Disease Control
and Prevention (CDC) to bolster public health activities.
--Please provide the new CDC Chronic Disease Education and
Awareness Program with $5 million, an increase of $3.5
million over FY 2021, to further advance and expand timely
public health efforts with community stakeholders.
--$9.2 billion for the Health Resources and Services Administration
(HRSA) and $500 million for the Agency for Healthcare Research
and Quality (AHRQ).
--PSI joins the broader patient advocacy community in requesting that
the subcommittee continue to use the annual appropriations
process, spending bills, and corresponding committee reports,
to advance efforts that improve coverage and access for
patients in need, including restoring equitable access to third
party assistance offered by reputable charities.
_______________________________________________________________________
Chairwoman Murray, Ranking Member Blunt, and distinguished member
of the Subcommittee, thank you for your leadership on health funding
and patient care issues. I am Gwen Cooper, and I look forward to
working with you as the CEO of PSI. We share a goal of improving the
lives of patients and families impacted by rare, chronic, and life-
threatening illness. In this regard, thank you for your ongoing efforts
to invest in medical research, public health, and patient care
programs. For FY 2022, please maintain this investment while continuing
to utilize the appropriations process to highlight systemic issues and
resolve contemporary coverage and access issues facing patients.
about psi
PSI is a national nonprofit charitable assistance program with over
30 years' experience assisting patients in obtaining healthcare
coverage and needed care and therapies. Founded by a patient for
patients, we know the challenges of chronic illness. We help pay for
medications, health insurance premiums and copays, navigate health
insurance plans, provide free legal services, and walk alongside
patients and their families through every step of their healthcare
journey. Over the last ten years, we have had the privilege of
providing over $800 million in financial assistance to help people
obtain the healthcare they so desperately need. In 2020 alone, nearly
15,000 patients from every state across the nation benefitted from $56
million in financial assistance from PSI. We are honored to do the
important work of breaking down barriers to healthcare access and
payment options so that patients with rare and chronic diseases can
focus on living their best lives.
about charitable assistance
Patient assistance charities, like PSI, primarily raise private
donations to provide health insurance premium assistance; pharmacy and
treatment costs, as well as travel, nursing and ancillary services. Our
programs help patients who are uninsured and underinsured in the
commercial market, and beneficiaries of public insurance coverage like
Medicare, Medicaid and TRICARE. PSI bridges the gaps in health coverage
for families by providing premium assistance for:
--Medicare beneficiaries for Medicare Part D plans,Medicare Advantage
plans and Medigap Plans.
--Patients during the 24-month waiting period for Medicare when
qualified for Social Security Disability.
--Patients who no longer qualify for the Medicaid program because of
age or income.
--Those who lose employer sponsored coverage through COBRA plans and
plans through the Marketplace. In 2020, over 16M Americans lost
their employer sponsored healthcare. PSI helped patients secure
new plans for coverage life-saving treatments.
When a patient turns to PSI, they often already have a doctor, and
health plan, and a course of therapy. PSI simply assists them with the
costs to maintain coverage and access, based on financial need and
other factors. For patients with life-threatening conditions, who wish
to continue working while managing their conditions, and those who do
not qualify for disability or need-based federal programs, maintaining
access to life-sustaining care is absolutely critical and few reliable
options exist without compassionate charitable assistance. Most
patients with rare and chronic diseases do not automatically quality
for disability, nor do they want to. They wish to continue living their
most productive lives through continued access to treatments required
to manage their illness.
contemporary examples of ``backdoors'' to pre-existing condition
discrimination
Third Party Payer
Center for Medicare and Medicaid Services (CMS) has discouraged
insurers from accepting payments from third party payers, including
organizations like PSI and other nonprofit patient assistance programs
(PAPs). This results in severe economic hardships for patients.
In November of 2013, CMS published a Frequently Asked Questions
(FAQ) document which discouraged health insurers from accepting
payments from third party payors on behalf of enrolled individuals.
This FAQ document was CMS' response to reported concerns, by insurers,
that accepting payments from someone other than the insured could skew
the insurance risk pool and create an unlevel field in the Exchanges.
A subsequent 2014 CMS FAQ document clarified that CMS had not
intended to discourage insurers from accepting third party premium and
cost-sharing payments from state and federal government programs,
Indian tribes, tribal organizations, and urban Indian organizations.
However, insurers were still discouraged from accepting third party
payments from any other organizations, including PAPs and other
charitable organizations, such as churches. This creates significant
barriers to care for many patients who deal with recurring costs and
chronic illnesses.
Copay Accumulators
CMS endorsed another tactic used by insurers to limit care for the
most ill (and, thus, most expensive) patients--the copayment
accumulator. A copay accumulator--or accumulator adjustment program--is
a strategy insurance companies and Pharmacy benefit Managers (PBMs) use
that stop manufacturer copay assistance coupons from counting towards a
patient's deductible and out-of-pocket maximum spending. This is like
saying a manufacturer's coupon would not lower your total grocery bill
when you use the coupon at the grocery store. These coupons help lower
the cost of medications in these scenarios: they can't afford the high
cost of the medication; they have a high deductible plan and cannot t
afford the copayment, and/or they qualify for PAP assistance but their
insurer will not accept the payment due to the CMS rule.
Because CMS has endorsed the copay accumulator mechanism, patients
often never reach their out-of-pocket maximum spending, putting other
treatment for their diseases in jeopardy.
Specialty Claim Carve-Out or Alternative Funding Model
This prescription drug procurement model improperly uses for-profit
drug manufacturers' free assistance programs to the detriment of
patients who are forced to continually switch drugs because
manufacturer assistance programs are time limited; diseases are not.
Additionally, any costs for filling the prescriptions or are not
counted toward the patient's out-of-pocket costs.
conclusion
Over previous years, appropriators have asked HHS and CMS to
explain the rationale and justifications for taking various coverage
and access actions. It would be meaningful to have the new
administration's perspective on these issues. The community would
welcome the opportunity to share their experiences and collaboratively
discuss challenges and opportunities with policymakers. In addition to
including timely committee recommendations, please consider questions
for the record and similar options to facilitate a productive
discussion with the administration on enhancing coverage and access
while Congress works on potential legislative solutions, as well. Thank
you again and please consider PSI a resource for future conversations.
[This statement was submitted by Gwen Cooper, Chief Executive
Officer, Patient Services, Inc.]
______
Prepared Statement of the Pediatric Policy Council
I write on behalf of the Pediatric Policy Council (PPC), a public
policy collaborative of the Academic Pediatric Association, the
American Pediatric Society, the Association of Medical School Pediatric
Department Chairs, and the Society for Pediatric Research. We urge the
subcommittee to provide robust investments in pediatric research and
training to support the health and well-being of children, as outlined
below. We are grateful for the investments Congress has made in these
areas in recent years, as evidenced in particular through enhanced
support for the National Institutes of Health (NIH) and other key
pediatric research priorities, and hope you will support sustained
increases in pediatric research and training priorities to enable the
next generation of scientific discoveries to benefit child health.
Fiscal Year (FY) 2022 Funding Priorities:
--National Institutes of Health: $46.1 billion
--Eunice Kennedy Shriver National Institute of Child Health and Human
Development: $1.7 billion
--Pediatric Subspecialty Loan Repayment Program: $50 million
--Gun Violence Prevention Research: $50 million split evenly between
NIH and CDC
--Agency for Healthcare Research and Quality: $500 million
--Children's Hospital Graduate Medical Education: $485 million
National Institutes of Health (NIH):
Biomedical research is key to improving child health and well-being
through new cures for pediatric conditions and a deeper understanding
of children's unique biology. Research funded by the NIH has made
significant strides toward treating and preventing chronic diseases,
many of which have their roots in childhood. This work has led to new
therapies, vaccines, and diagnostic tests that have improved the lives
of millions of people worldwide. Pediatric research has yielded
groundbreaking treatments for deadly chronic diseases, saved the lives
of premature babies, and even cured some common childhood cancers. NIH
funding also helps fund the development of physician scientists through
loan repayment and research training awards. The COVID-19 pandemic has
only further underscored the importance of the federal investment in
biomedical research, which was crucial in developing the scientific
knowledge and infrastructure to rapidly study the novel coronavirus in
children and adults and to develop needed medical interventions like
immunizations that will be key to ending the pandemic.
We urge a funding level for NIH of no less than $46.1 billion in FY
2022, a $3.2 billion increase over the agency's FY 2021 level. Within
the overall FY 2022 funding for the NIH, we request $1.7 billion for
the Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)--the single largest funder of pediatric research
within the NIH and a key leader in coordinating and advancing a
pediatric research agenda NIH-wide. This amounts to a proportionate
increase for NICHD of $117 million over FY 2021.
Pediatric Subspecialty Loan Repayment Program (PSLRP):
Across the country, there are significant shortages of pediatric
subspecialists--pediatricians who pursue additional training to care
for the most medically complex children--which lead to long travel
distances and long appointment wait times for families. There is also a
disparity in the geographic distribution of pediatric subspecialists,
resulting in many children in underserved rural and urban areas not
receiving timely health care. Shortages of pediatric subspecialists may
also slow the development of the next generation of treatments and
cures for young people, since many pediatric researchers are trained as
subspecialists and dedicate their careers to research on complex health
needs like Type 1 diabetes and autism spectrum disorder.
PSLRP is designed to address these shortages by providing
qualifying child health professionals with up to $35,000 in loan
repayment annually in exchange for practicing in an underserved area
for at least two years, which would help address high medical school
debt that serves as a barrier to pursuing training in a pediatric
subspecialty. Congress reauthorized this program last year in the
Coronavirus Aid, Relief, and Economic Security (CARES) Act in
recognition of the need to support child access to pediatric medical
and mental health care amid the COVID-19 pandemic. We urge you to begin
addressing these shortages by providing $50 million in initial funding
for PSLRP in FY 2022.
Gun Violence Prevention Research:
Gun violence is a public health crisis for citizens of all ages,
genders, races, ethnicities, and socio-economic backgrounds--and this
includes for children and youth. Firearms are now the leading cause of
death for those 1-24 years old in the United States. Suicide accounts
for 40% of these deaths. In the last decade, an increasing number of
teenagers and young adults have died by suicide using a gun, which
results in death more than 90 percent of the time. Funding to better
elucidate risk and protective factors for gun violence in children and
youth and their families is critical to decrease gun deaths and
injuries. For the first time in 25 years, Congress provided a welcomed
investment in this research in FY 2020 and again in FY 2021 at the NIH
and the Centers for Disease Control and Prevention (CDC). After the
absence of research funding for almost 3 generations of young
investigators, additional funding is needed to rebuild the public
health research infrastructure needed for gun violence. We therefore
urge you to provide $50 million in funding for gun violence prevention
research split evenly between the NIH and the CDC, a doubling of
current funding in line with President Biden's FY 2022 budget request.
Agency for Healthcare Research and Quality (AHRQ):
The Agency for Healthcare Research and Quality (AHRQ) funds
research into health care as it is practiced to improve care in the
clinic and support quality improvement. For instance, AHRQ research has
helped reduce unnecessary blood cultures in critically ill children and
led to important insights about the health and economic benefits of
increased physical activity in children. AHRQ has also played an
important role in the development and evaluation of the Pediatric
Quality Measures Program (PQMP), which is helping to improve quality of
care for the 37.6 million children enrolled in Medicaid and the
Children's Health Insurance Program. We urge you to provide $500
million in funding for AHRQ in FY 2022.
Children's Hospital Graduate Medical Education (CHGME):
The ability to produce top quality pediatric research is dependent
on the availability of trained pediatrician scientists who choose to
pursue a career in research. Many factors influence a physician's
choice to pursue research, but a stable pipeline of trained clinicians
is a critical prerequisite. Freestanding children's hospitals train
half of all pediatricians and pediatric subspecialists despite
representing less than one percent of hospitals. CHGME is necessary to
maintain the number of pediatric residents and fellows in the United
States and has allowed participating children's hospitals to improve
their training experience for residents and fellows. A strong
investment in pediatric training through freestanding children's
hospitals is essential to ensuring that future pediatrician scientists
are trained and have the opportunity to pursue pediatric research. We
urge you to provide $485 million in funding for CHGME in FY 2022.
______
Prepared Statement of Peel Ann D. deg.
Prepared Statement of Ann D. Peel
Madam Chairwoman,
Amyloidosis is a rare and usually fatal disease. There is no known
cure for amyloidosis, an abnormal folding protein disease that can
destroy various major organs. The causes of the disease remain elusive.
I ask that you include language in the Committee's report for fiscal
year 2022 directing the National Institutes of Health (NIH), Office of
the Director, Multi-Institute Research Issues to expand its research
efforts into amyloidosis. I also ask the Committee to direct NIH to
inform Congress on the steps taken to increase the understanding of the
causes of amyloidosis and the measures taken to improve the diagnosis
and treatment of this devastating group of diseases. The vaccines
developed to combat COVID-19 illustrate the importance of the research
necessary to overcome diseases. Only through more research can deaths
from amyloidosis be prevented.
Over the years, your Committee has been instrumental in moving
forward to finding the causes and a cure for amyloidosis. Efforts made
by NIH and Amyloidosis Centers around the country are resulting in many
more people being diagnosed and treated for amyloidosis than a decade
ago.
I have endured two stem cell transplants in order to fight the
deadly disease amyloidosis and have been one of the lucky ones to
survive the disease for 18 years. This was due to the intensive, life-
saving treatment that I have received through the Amyloidosis Center at
Boston University School of Medicine and Boston Medical Center. I
continue to participate in a clinical trial that looks for ways to
diagnose and treat amyloidosis.
One of the major concerns is that current methods of treatment are
risky and unsuitable for many patients. Even with successful initial
treatment, amyloidosis remains a threat, since it can recur years
later.
Due to research, there are new forms of treatment that are options
for me and patients with recurring amyloidosis. These new treatment
options were not available 18 years ago. They provide evidence that
funding through Health and Human Services can make a difference.
I ask for your support in helping me turn what has been my life-
threatening experience into hope for others.
what is amyloidosis?
I have been treated for primary amyloidosis, which is
immunoglobulin light chain (AL) amyloidosis. This type of amyloidosis
occurs when cells in the bone marrow produce an abnormal amyloidogenic
protein and these form amyloid fibrils that are deposited in major
organs, such as the heart, kidney and liver. These misfolded proteins
clog the organs until they are no longer able to function-sometimes at
a very rapid pace.
In addition to AL amyloidosis, a blood or bone marrow disorder,
there are also cases of inherited or familial amyloidosis and secondary
or reactive amyloidosis. Familial amyloidosis may be present in a
significant number of African Americans.
All three types of amyloidosis, left undiagnosed or untreated, are
fatal. There is no explanation for how or why amyloidosis develops and
there is no known reliable cure. Thousands of people die because they
were diagnosed too late to obtain effective treatment. Thousands of
others die never knowing they had amyloidosis. The small numbers of
those with amyloidosis who are able to obtain treatment face challenges
that can include high dose chemotherapy and stem cell replacement or
organ transplantation.
Amyloidosis can cause heart, kidney, or liver dysfunction and
failure and severe neurological problems. Left untreated, the average
survival is just months from the time of diagnosis.
Researchers have not been able to determine the root cause of the
disease or an effective low-risk treatment. Amyloidosis can literally
kill people before they even know that they have the disease.
Older Americans are susceptible to heart disease due to amyloid
formed from the non-mutated form of the same protein. Another type of
amyloidosis, secondary or reactive amyloidosis, occurs in patients with
chronic infections or inflammatory diseases.
All of these types of amyloidosis, left undiagnosed or untreated,
are fatal.
how is amyloidosis treated?
Boston University School of Medicine and other centers for
amyloidosis treatment have found that high dose intravenous
chemotherapy followed by stem cell replacement, or rescue, is an
effective treatment in selected patients with AL amyloidosis. Abnormal
bone marrow cells are killed through high dose chemotherapy and the
patient's own extracted blood stem cells are replaced in order to
improve the recovery process. The high dose chemotherapy and stem cell
rescue and other new drugs have increased the remission rate and long-
term survival dramatically. However, this treatment can also be life
threatening and more research needs to be done to provide less risky
forms of treatment.
Timely diagnosis and treatment are of great importance. Early
treatment is the key to success.
More needs to be done in this area to alert health professionals to
identify this disease.
research and diagnosis
Researchers are moving forward with limited funding to develop
targeted treatments that will specifically attack the amyloid proteins.
Additional funding for research and equipment is needed to accomplish
this task. Only through more research is there hope of further
increasing the survival rate and finding treatments to help more
patients.
Amyloidosis is vastly under-diagnosed. Thousands of people die
because they were not diagnosed or diagnosed too late. More needs to be
done to alert health professionals to identify this disease. Although I
was diagnosed at a very early stage of the disease, many people are
diagnosed after the point that they are physically able to undertake
treatment.
I believe there are many more cases of amyloidosis than are known,
as the disease can escape diagnosis and patients die of ``heart
failure,'' ``liver failure,'' etc. In reality, some of these people had
amyloidosis. Perhaps amyloidosis is not as rare a disease as we think.
Through the leadership of this Committee and the further
involvement of the U.S. Government, several positive developments have
occurred. Research supported by the National Institute of Neurologic
Disorders and Stroke at NIH and the Office of Orphan Products
Development at the Food and Drug Administration led to successful
repurposing of a generic drug that markedly slows progression of
familial amyloidosis.
Basic and clinical research at the Boston University Amyloidosis
Center has increased: models of light chain (AL) amyloid disease have
been developed; serum chaperone proteins that cause amyloid precursor
protein misfolding are being identified; imaging techniques for the
diagnosis of amyloid disease are being investigated; and new clinical
trials for primary and familial amyloidosis are underway. Federal
funding for research, equipment and treatment has been an important
element in progress to date. Further funding is essential to speed the
pace of discovery for basic and clinical research.
Madam Chairwoman, the United States Congress and the Executive
branch working together are key to finding a cure for and alerting
people to this terrible disease.
I want to use my experience with this rare disease to help save the
lives of others. With your support more can be done to help me achieve
my dream.
______
Prepared Statement of the Personalized Medicine Coalition
Chairwoman Murray, Ranking Member Blunt and distinguished members
of the subcommittee, the Personalized Medicine Coalition (PMC)
appreciates the opportunity to submit testimony on the National
Institutes of Health (NIH) fiscal year (FY) 2022 appropriations and the
importance of the agency's research to personalized medicine. PMC is a
nonprofit education and advocacy organization comprised of more than
220 institutions from across the health care spectrum who support this
growing field. The tragically uneven effects of the COVID-19 pandemic
have underlined the importance of developing more targeted health care
interventions just as groundbreaking technologies are giving us an
unprecedented ability to understand the biological and environmental
factors that drive disease and influence patients' responses to various
treatments. As the subcommittee begins work on the FY 2022 Labor,
Health and Human Services, Education and Related Agencies
appropriations bill, we strongly support the President's proposed
increase in funding for NIH to $51 billion, and we request the agency
receive no less than $46.1 billion for NIH's base program level budget,
$3.2 billion above the comparable FY 2021 funding level.
Personalized medicine, also called precision or individualized
medicine, is an evolving field in which physicians use diagnostic tests
to determine which medical treatments will work best for each patient
or use medical interventions to alter molecular mechanisms that impact
health. By combining data from diagnostic tests with an individual's
medical history, circumstances and values, health care providers can
develop targeted treatment and prevention plans with their patients.
Personalized medicine promises to detect the onset of disease, pre-empt
its progression, and improve the quality, accessibility, and
affordability of health care.\1\ By increasing government spending on
science at this pivotal moment, Congress can help advance a new era of
personalized medicine that promises a brighter future for patients and
health systems.
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\1\ http://www.personalizedmedicinecoalition.org/Userfiles/PMC-
Corporate/file/PMC_The_
Personalized_Medicine_Report_Opportunity_Challenges_and_the_Future.pdf.
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i. the role of nih in personalized medicine
Continued research on the genetic and biological underpinnings of
disease has made it possible to develop new personalized medicine
treatments for cancers as well as rare, common, and infectious
diseases. This research has informed the development of more than 286
personalized treatments \2\ and over 166,703 genetic testing products
\3\ available for patients in 2020. Foundational advances in genetic
and genomic technologies have also paved the way for scientists' rapid
response to COVID-19. The rapid progress we have seen, from mRNA
vaccine development, diagnostic testing, and variant sequencing, to
beginning to understand how human genomic variation influences
infectivity, disease severity, vaccine efficacy, and treatment
response, relies on years of personalized medicine research,\4,5\--as
well as years of diligent funding from Congress to support this
research.
---------------------------------------------------------------------------
\2\ http://www.personalizedmedicinecoalition.org/Userfiles/PMC-
Corporate/file/PMC_The_
Personalized_Medicine_Report_Opportunity_Challenges_and_the_Future.pdf.
\3\ https://doi.org/10.1002/ajmg.c.31881.
\4\ https://doi.org/10.1016/j.cell.2021.01.015.
\5\ https://doi.org/10.1038/s41586-020-2817-4.
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The widely variable effects of COVID-19 have only highlighted the
need for personalized medicine to move further and faster. A $3.2
billion increase would allow for NIH's base budget to keep pace with
biomedical inflation and allow meaningful growth of 5 percent. This
request also includes the full $496 million NIH is scheduled to receive
in FY 2022 from the Innovation Account established in the 21st Century
Cures Act (Cures Act).
ii. sustaining basic and translational research for personalized
medicine
NIH is leading scientific discovery for personalized medicine,
which begins with basic research that generates fundamental knowledge
about the molecular basis of a disease and with translational research
aimed at applying that knowledge to develop a treatment or cure. Many
institutes and centers at the NIH are supporting research informing the
development of personalized medicines, including the National Human
Genome Research Institute (NHGRI), the National Cancer Institute (NCI),
the National Institute on Aging (NIA), the National Heart, Lung and
Blood Institute (NHLBI), and the National Center for Advancing
Translational Sciences (NCATS). An increase for NIH in FY 2022 would
protect its foundational role in the identification and development of
treatments, technologies, and tools for personalized medicine.
The future of cancer care, for example, is expected to be
profoundly influenced by personalized medicine approaches for detecting
and treating early- and late-stage cancers. In 2020, for example, FDA
approved the first comprehensive pan-tumor liquid biopsy test for
patients with advanced cancer that allows physicians to detect
actionable biomarkers in patients' blood through next-generation
sequencing.\6\ As soon as next year, NCI aims to launch large national
trials for similar tests that are being developed to detect multiple
early-stage cancers in patients' blood.\7\ These tests would provide
less invasive testing options that can detect cancers at early stages
when treatment may be more effective and less costly.
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\6\ http://www.personalizedmedicinecoalition.org/Userfiles/PMC-
Corporate/file/PM_at_FDA_
The_Scope_Significance_of_Progress_in_2020.pdf.
\7\ https://www.precisiononcologynews.com/policy-legislation/nci-
director-sharpless-outlines-ideas-aggressively-lower-cancer-deaths.
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Basic and translational research also offers opportunities for
personalized medicine beyond oncology, especially for rare diseases.
Although individually rare, rare diseases collectively affect an
estimated 25 to 30 million Americans. With advances in genomics, the
molecular causes of 6,500 rare diseases have been identified--but only
about 5 percent have an FDA-approved treatment, and in 2019, the
estimated economic cost of only 379 rare diseases reached nearly $1
trillion in the U.S.\8\ Over the past decade, NIH has helped shift the
scientific approach to researching rare diseases from one disease at a
time to many diseases. Pooling patients, data, experiences, and
resources promises to lead to more successful clinical trials sooner
for rare disease patients who presently have few or no treatment
options.
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\8\ https://everylifefoundation.org/burden-study/.
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There are others living with highly prevalent diseases where
personalized medicine can offer patients better treatments or a cure.
The Alzheimer's Association estimates that 6.2 million Americans are
living with Alzheimer's disease, for example.\9\ Despite increasing
numbers of Alzheimer's diagnoses and FDA's recent approval of the first
new Alzheimer's drug in decades, researchers are still studying the
genetic underpinnings of Alzheimer's disease to more fully understand
its complexity. To shorten the time between the discovery of potential
drug targets and the development of new drugs, the Accelerating
Medicines Partnership for Alzheimer's disease led by NIH has identified
over 500 drug targets, and in 2020 launched a second iteration of the
partnership to enable a personalized medicine approach to researching
new treatments.\10\
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\9\ https://www.alz.org/media/Documents/alzheimers-facts-and-
figures.pdf.
\10\ https://www.nih.gov/research-training/accelerating-medicines-
partnership-amp/alzheimers-disease.
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Still, ensuring that the scientific breakthroughs in personalized
medicine are impactful to all patients will require the inclusive and
equitable representation of patients with diverse characteristics and
health needs in research. Improving research policies and incorporating
diverse perspectives into solving complex scientific problems, such as
through NIH's UNITE initiative and NHGRI's action agenda for a diverse
genomics workforce, will play a key role in addressing these
disparities, in addition to research on improving minority health and
understanding factors contributing to health disparities.
iii. accelerating personalized medicine research
Increasing the NIH's base budget will also ensure that the agency
has the resources necessary to advance the longstanding aspects of its
mission without de-prioritizing supplemental initiatives in
personalized medicine provided for by Congress in the Cures Act.
The first initiative, the All of Us\TM\ Research Program, was
launched in 2018 to begin collecting genetic and health information
from one million volunteers as part of a decades-long research project.
As of May 2021, over 382,000 individuals consented to participate and
over 279,000 have fully enrolled.\11\ More than 80 percent of those
individuals are from groups historically underrepresented in
research,\12\ such as seniors, women, Hispanics and Latinos, African
Americans, Asian Americans and members of the LGBTQ community. Last
year, program officials met their targets to start returning individual
genetic results to participants and inviting researchers to begin using
the data collected.\13\ The program also began analyzing data from its
diverse participant cohort to look for patterns explaining individuals'
different responses to COVID-19.\14\ In the future, pooling health care
data across large datasets will play a key role in advancing research
for personalized medicine approaches to care.
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\11\ https://www.joinallofus.org/newsletters/2021/may.
\12\ https://doi.org/10.1016/j.cell.2021.01.015.
\13\ https://www.joinallofus.org/newsletters/2020/december.
\14\ https://www.nih.gov/news-events/news-releases/all-us-research-
program-launches-covid-19-research-initiatives.
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The second initiative, the Beau Biden Cancer Moonshot, aims to
transform the way cancer research is conducted by fostering
collaboration and data sharing. Moonshot currently supports over 240
new research projects, \15\ including the Partnership for Accelerating
Cancer Therapies (PACT). Through PACT, the NIH is collaborating with 12
pharmaceutical companies, the Foundation for NIH, and FDA to identify,
develop, and validate biomarkers to advance the discovery of new
immunotherapy treatments. Over the past decade, personalized treatments
harnessing the immune system have driven declines in mortality for lung
cancer and melanoma.
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\15\ https://doi.org/10.1016/j.ccell.2021.04.015.
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iv. conclusion
PMC appreciates the opportunity to highlight the NIH's importance
to the continued success of personalized medicine. As the subcommittee
considers the President's proposal, we encourage the subcommittee to
support at least a $3.2 billion increase for existing centers and
programs, in addition to funding Congress may provide for targeted
initiatives such as establishing the President's proposed Advanced
Research Projects Agency for Health (ARPA-H). PMC believes that
diligently funding basic and translational research at the NIH is key
to bringing us closer to a future in which every patient benefits from
an individualized approach to health care.
[This statement was submitted by Cynthia A. Bens, Senior Vice
President, Public Policy, Personalized Medicine Coalition.]
______
Prepared Statement of the Physical Activity Alliance
Members of the subcommittee, thank you for the opportunity to
testify today. My name is Mark Fenton. I am an adjunct associate
professor at Tuft University and a nationally recognized public health,
planning, and transportation consultant. I am representing the Physical
Activity Alliance, the nation's broadest coalition dedicated to
promoting physical activity for health. As such, I'm pleased to testify
today on specific opportunities to improve Americans' health in the
fiscal year (FY) 2022 Labor, Health and Human Services, Education and
Related Agencies appropriations bill that address funding for the
Centers for Disease Control and Prevention. I respectfully request you
work over the next three years to triple the budget of the Centers for
Disease Control and Prevention (CDC) National Center for Chronic
Disease Prevention and Health Promotion (NCCDPHP) to $3.75 billion,
including in this next budget at least $125 million for the Division of
Nutrition, Physical Activity and Obesity (DNPAO), and $10 million for
Active People Healthy Nation (APHN), an initiative to help 27 million
Americans become more physically active by 2027.
The Active People Healthy Nation support would build on the
increased capacity of the public health infrastructure from a 50-state
DNPAO program funding commitment. The 50-state program, including the
District of Columbia, would allow for each state to have resources for
staff who are experts in:
--Promoting physical activity through community and state changes to
increase safe and convenient access to physical activity,
especially for those populations most at risk of physical
inactivity, through activities such as master planning, access
to parks, safe routes to school, and improvements for
physically active (walking and bicycling) routes to everyday
destinations.
--Promoting nutrition security especially for the youngest and most
vulnerable populations
--Obesity prevention and management with linkages to health care
systems
--Communication and policy
--Evaluation, quality improvement and accountability
--Equitable and inclusive community engagement
The specific resources for Active People Heathy Nation would allow
states, municipalities and, local communities to leverage the expertise
of the 50-state program to specifically address the populations who are
the most disproportionately affected by risk of chronic diseases
(including obesity, diabetes, cancer and heart disease) due to their
lack of safe and convenient access to physical activity. This could
include but is certainly not limited to:
--Implementing social support systems and networks to promote walking
for older populations.
--Implementing low-cost ``quick builds'' to improve street designs to
encourage safe walking and biking at the local level in
specific neighborhoods where health disparities are the
greatest.
--Convening local groups to develop action plans for promoting safe
and convenient access to local parks and other key
destinations.
--Promoting safe routes to schools with design changes (e.g., high
visibility crosswalks, traffic calming near schools) to
increase safety and to reduce hesitancy from parents.
--Taking steps to prioritize safety over speed in local and state
policies and practices.
As a consultant to communities across the country, I have seen the
positive impact of these funds in communities, especially for those
that are historically under-resourced. The pandemic has demonstrated
that chronic diseases and infectious diseases are inextricably linked
and inequity can be exacerbated. Addressing chronic diseases, their
associated risk factors, as well as mental health and well-being are
essential for improving our population health and productivity. And
physical activity to improve cardiorespiratory fitness are integral
interventions. Being physically active is one of the most important
lifestyle behaviors people can engage in to maintain their physical
health, improve their mental health, and optimize well-being.\1\
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\1\ US Department of Health and Human Services. Physical Activity
Guidelines for Americans, 2nd edition. 2018.
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--Studies show that physical activity is associated with strong
immune response, better outcomes from community-acquired
infectious disease, reduced mortality and increased vaccine
potency.\2,3,4,5\
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\2\ Nieman DC, Wentz LM. The compelling link between physical
activity and the body's defense system. J Sport Heal Sci. Published
online 2019. doi:10.1016/j.jshs.2018.09.009.
\3\ Hamer M, Kivimaki M, Gale CR, David Batty G. Lifestyle risk
factors, inflammatory mechanisms, and COVID-19 hospitalization: A
community-based cohort study of 387,109 adults in UK. Brain Behav
Immun. Pblished online 2020.
\4\ Dixit S. Can moderate intensity aerobic exercise be an
effective and valuable therapy in preventing and controlling the
pandemic of COVID-19? Med Hypotheses. Published online 2020.
\5\ Perico, L., Benigni, A., Casiraghi, F., Ng, LFP., Renia, L.,
Remuzzi, G. Immuity, endothelial injury and complement-induced
coagulopathy in COVID-19. Nature Reviews Nephrology. October 2020.
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--Physical activity also contributes to social connectedness,\6\
quality of life,\7\ and environmental sustainability.\8,9\
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\6\ Wray, A., Martin, G., Ostermeier, E., Medeiros, A., Little, M.,
Reilly, K., Gilliland, J. Physical activity and social connectedness
interventions in outdoor spaces among children and youth: a rapid
review. Health Promotion and Chronic Disease Prevention in Canada.
Research Policy and Practice. April 2020; 40(4): 1-12.
\7\ Posadzki, P., Pieper, D., Bajpai, R., Makaruk, H., Kongsen, N.,
Lena Neuhaus, A., Semwal, M., Exercise/physical activity and health
outcomes: an overview of Cochrane systematic reviews. BMC Public
Health. November 2020. https://bmcpublichealth.biomedcentral.com/
articles/10.1186/s12889-020-09855-3.
\8\ Global Advocacy Council for Physical Activity International
Society for Physical Activity and Health. The Toronto Charter for
Physical Activity: A Global Call for Action. J Phys Act Health. 2010;7
Suppl 3:S370-85.
\9\ Safe routes to school: Steps to a greener future. How walking
and bicycling to school reduce carbon emissions and air pollutants.
Accessed online November 2020 at https://www.saferoutespartnership.org/
sites/default/files/pdf/SRTS_GHG_lo_res.pdf.
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--Regular physical activity is both health-promoting and important
for treatment and prevention of diseases such as cardiovascular
disease and cancer that are the leading causes of death in the
U.S., with numerous benefits that contribute to a disability-
free lifespan.\10\
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\10\ Wen CP and Wu X. Stressing harms of physical inactivity to
promote exercise. Lancet. 2012;380:192-3.
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--There are racial, ethnic and socioeconomic status (SES) disparities
that exist with regard to physical activity, access to
recreational spaces and physical activity-related programs.
These disparities differ with respect to occupation,
transportation, community infrastructure, and
leisure.\11,12,13\
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\11\ Thornton, C.M., Conway, T.L., Cain, K.L., Gavand, K.A.,
Saelens, B.E., Frank, L.D., Geremia, C.M., Glanz, K., King, A.C., and
Sallis, J.F. Disparities in pedestrian streetscape environments by
income and race/ethnicity. SSM-Population Health, 2016; 2, 206-216.
\12\ Engelberg, J.K., Conway, T.L., Geremia, C., Cain, K.L.,
Saelens, B.E., Glanz, K., Frank, L.D., and Sallis, J.F. Socioeconomic
and race/ethnic disparities in observed park quality. BMC Public
Health, 2016;16:395.
\13\ Jones, SA., Moore, LV., Moore, K., Zagorski, M., Brines, SJ.,
Diez Roux, A., Evenson, KR. Disparities in physical activity resource
availability in six US regions. Prev Med. 2015; 78:17-22.
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--Low physical activity and fitness pose immediate and long-term
threats to our nation's safety and security. Currently, 71
percent of Americans ages 17-24 fail to meet core eligibility
requirements for entrance into the military, creating a serious
recruiting deficit.\14\ Among those who do meet basic
requirements for service, musculoskeletal injuries associated
with low fitness levels cost the Department of Defense hundreds
of millions of dollars,\15\ and have been identified as the
most significant medical impediment to military readiness.\16\
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\14\ U.S. Department of Defense, Joint Advertising Market Research
and Studies. (2016). The target population for military recruitment:
youth eligible to enlist without a waiver. https://
dacowits.defense.gov/Portals/48/Documents/General%20Documents/
RFI%20Docs/Sept2016/JAMRS%20RFI%2014. pdf?ver=2016-09-09-164855-510.
\15\ Bulzacchelli M, Sulsky S, Zhu L, Brandt S, Barenberg A. The
cost of basic combat training injuries in the U.S. Army: injury-related
medical care and risk factors. In: Military Performance Division, U.S.
Army Research Institute of Environmental Medicine. Edited by Natick MA,
March 2017.
\16\ Hauret KG, Jones BH, Bullock SH, Canham-Chervak M, Canada S.
Musculoskeletal injuries description of an under-recognized injury
problem among military personnel. AmJ Prev Med. Jan 2010;
38(1)(suppl):S61-S70.
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Streets and downtowns that are designed to safely accommodate the
physically active modes (walking, biking, and transit) along with motor
vehicles are more economically robust,\17\ have more resilient real
estate values,\18\ and are increasingly appealing to businesses because
of enhanced employee recruitment and retention.\19\
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\17\ Liu JH, Wei S, Understanding Economic and Business Impacts of
Street Improvements for Bicycle and Pedestrian Mobility: A Multi-City,
Multi-Approach Exploration. Nat'l Inst. for Transportaion &
Communities, NITC-RR-1031-1161, April 2020.
\18\ Bokhari S, How Much is a Point of Walkscore Worth? https://
www.redfin.com/news/how-much-is-a-point-of-walk-score-worth/. Aug 2016,
update Oct. 2020.
\19\ Andersen M, Hall ML, Protected Bike Lanes Mean Business,
Alliance for Biking and Walking, 2016, https://
www.peoplepoweredmovement.org/site/images/uploads/Protected_Bike_Lanes
_Mean_Business.pdf.
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Physical activity is integral to population health and well-being,
educational achievement, effective health care delivery, emergency
preparedness, and military readiness, and will be critical to our
nation's recovery from the pandemic. If we can help more Americans to
be physically active, we will save lives, contribute to lower vehicle
emissions and health care costs, reduce racial, ethnic, gender, and
socioeconomic health disparities, improve mental well-being, and make
American employers and the U.S. overall much more productive and
successful.
I thank you for the opportunity to offer my perspective today, and
for your continued leadership.
______
Prepared Statement of Planned Parenthood
Dear Chairwoman Murray and Ranking Member Blunt,
Planned Parenthood is the nation's leading reproductive health care
provider and advocate and a trusted, nonprofit source of primary and
preventive care for women, men, and young people in communities across
the U.S as well as the nation's largest provider of sex education. As
experts in sexual and reproductive health care, we reach 2.4 million
people in our health centers, 1.1 million people through educational
programs, and see 198 million visits to our website every year. People
come to Planned Parenthood for the accurate information and critical
resources they need to stay healthy and reach their life goals. For
many of our patients, Planned Parenthood is their only source of care--
making our health centers an irreplaceable part of this country's
health care system. Backed by more than 17 million supporters, Planned
Parenthood Action Fund works every day to defend access to health care
and advance reproductive rights at home and abroad. Through our
international arm, Planned Parenthood Global, we provide financial and
technical support to nearly 100 innovative partners in nine countries
in Africa and Latin America for service delivery and advocacy to expand
access to reproductive health care and empower people to lead healthier
lives.
Longstanding progress towards addressing sexual and reproductive
health both here in the United States and around the world has been
undermined and is threatened to erode further--both deliberately and as
a result of unprecedented challenges, most notably the COVID-19
pandemic. The Biden-Harris administration has taken welcome early
actions to reverse the Trump-Pence administration's ideological and
harmful policies--including the global gag rule and Title X domestic
gag rule--and prioritize sexual and reproductive health and rights, but
more action is needed from both the administration and congress to
ground policies in science and equity and expand access to health care,
including sexual and reproductive health, for millions, particularly
for those who most often struggle to overcome the systemic barriers to
care. Meanwhile the pandemic has exacerbated existing inequities in
health care systems and created a growing need for timely services,
including those to help with the growing number of households that have
identified a need for affordable family planning and increasing rates
of sexually-transmitted infections (STIs).
Through these extraordinary challenges, Planned Parenthood health
centers continue to expand services and innovate new and better ways to
deliver health care and information--through telehealth and in health
centers across the country. We are breaking down structural barriers to
accessing reproductive health care by making it more timely, relevant
and equitable for all people.
However, there remain significant and unacceptable inequities in
health outcomes that are the result of longstanding systems of
oppression that deeply impact traditionally marginalized communities,
including persons of color, those with low-incomes, those who identify
as LGBTQ, and those who live at the intersection of structural racism,
inequality, sexism, classism, xenophobia, and other systemic barriers
to health care and other resources are among those most severely
impacted. The ongoing COVID-19 pandemic has underscored the inequities
in access to health care worldwide, both within and between countries,
and is further exacerbating gender-based violence and the financial
barriers to seeking care that is needed, including sexual and
reproductive health services.
On behalf of Planned Parenthood Federation of America, I
respectfully request that while assembling legislation to provide
appropriations for fiscal year 2022 (FY22) you provide increased
funding for key sexual and reproductive health funding priorities while
also ending harmful and discriminatory policies that undermine access
to care, including by:
1. Building Back the Title X Family Planning Program
2. Increasing Funding for STI Prevention
3. Increasing Funding for the Teen Pregnancy Prevention Program and
the CDC's Division of Adolescent School Health, and Eliminate Harmful
and Ineffective Abstinence-Only-Until-Marriage Programs
4. Eliminating Harmful Policy Riders that Limit Access to Abortion
1. Building Back the Title X Family Planning Program
Title X is the nation's only federal program dedicated to providing
affordable birth control and other reproductive health care to people
with low incomes. Despite mass outcry from the public health community
and American people, in August 2019 the Trump administration began
enforcing a rule that made significant changes to Title X. The gag
rule--a harmful regulation that prohibits Title X providers from giving
their patients full and accurate information--dismantles the program
and blocks people struggling to get by from getting free or low-cost
birth control, STI services, cancer screenings, and other essential
health care. The gag rule slashed the Title X network's patient
capacity nearly in half, creating unacceptable barriers to affordable
care. The gag rule resulted in family planning providers in 33 states
leaving the program and at least 1.5 million people, many of whom are
low-income, losing access to Title X-funded care at the site they had
used in 2018. More than 1,000 sites (roughly 25 percent) have left the
Title X network; six states (HI, ME, OR, UT, VT, and WA) currently have
no Title X-funded services.
In the meantime the COVID-19 pandemic has further exacerbated the
county's sexual and reproductive health care needs. In spring 2020, 33
percent of women faced delays or were unable to get contraception or
other care because of the COVID-19 pandemic, while 34 percent wanted to
get pregnant later or wanted fewer children because of the pandemic.
Women belonging to groups already experiencing systemic health and
social inequalities--such as Black and Latina women, queer women, and
low income women--reported the greatest change in fertility preference
and barriers to access.
In April 2021, the Biden administration issued a notice of proposed
rulemaking and we applaud their proposal to rescind the gag rule and
make several modifications aimed at ``strengthen[ing] the program and
ensur[ing] access to equitable, affordable, client-centered, quality
family planning services for all clients, especially for low-income
clients.'' \1\ However, an increase in annual funding will be necessary
to help rebuild the Title X network and provide much-needed care to
qualifying participants.
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\1\ https://www.hhs.gov/about/news/2021/04/14/fact-sheet-notice-of-
proposed-rulemaking-ensuring-access-to-equitable-affordable-client-
centered.html.
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The best analysis (conducted prior to the pandemic and without
adjusting for inflation) estimates that the Title X program would need
$737 million in annual funding to address the unmet family planning
needs for low-income women. We urge Congress to provide the program
with $512 million in FY22 funding--an increase halfway towards the
unmet need of the program--to help rebuild the Title X network and
restore access to critical health care services.
2. Increasing Funding for STI and HIV Prevention at the Centers for
Disease Control and Prevention (CDC)
Sexually-transmitted infections (STIs) are a serious and growing
public health problem. This month the latest annual CDC surveillance
report announced that STD rates have reached an all-time high for the
sixth consecutive year. In 2019, more than 2.5 million cases of
syphilis, chlamydia, and gonorrhea diagnoses were identified in the
United States.\2\ Of particular concern were cases of congenital
syphilis--syphilis passed from a mother to her baby during pregnancy--
which have quadrupled between 2015. Congenital syphilis can result in
miscarriage, stillbirth, newborn death, and severe lifelong physical
and neurological problems. The report also identified that disparities
in rates persist among racial and ethnic groups. For example, STD rates
for Hispanic or Latino people ranging up to two times those of non-
Hispanic White people. Rates for American Indian or Alaska Native and
Native Hawaiian or Other Pacific Islander people were 3-5 times as high
while rates for African American or Black people were five to eight
times those of non-Hispanic White people. All of this has likely been
exacerbated by the COVID-19 pandemic which has reduced access to
essential screening and treatment services and stretched public health
resources thin.
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\2\ Centers for Disease Control and Prevention (CDC). 2019 STD
Surveillance Report. April 13, 2021. https://www.cdc.gov/nchhstp/
newsroom/2021/2019-STD-surveillance-report.html.
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Screening and treatment for STIs-including HIV/AIDS-are an
essential part of planning for a healthy pregnancy and healthy
communities. Despite the CDC recommendation that all pregnant women be
tested for STIs, many women and other sexually active adults are not
being adequately tested, in part because of limited resources for
screening. The CDC's National Center for HIV/AIDS, Hepatitis, STIs and
TB Prevention (NCHHSTP) conducts critical public health surveillance,
but also funds screenings and other important activities. Increasing
funding for the CDC's STI prevention programs is a cost-effective
public health investment that will improve the lives of women and all
Americans across the country. We ask that you fund CDC/NCHHSTP at $1.4
billion for FY22, including $252.91 million for the Division of STD
Prevention.
3. Increasing Funding for the Teen Pregnancy Prevention Program and the
CDC's Division of Adolescent School Health, Eliminate Harmful
and Ineffective Abstinence-Only-Until-Marriage Programs
As the nation's leading provider of sex education, Planned
Parenthood works in and with communities across the country to provide
outstanding sex education programs. Our educators see daily how vital
it is for young people to have access to sex education programs that
give them knowledge and skills they need to lead fulfilling, safe, and
healthy lives. However, less than 43 percent of all high schools and
only 18 percent of middle schools across the country provide education
on all of the CDC's identified topics that are critical to ensuring
sexual health.\3\ Congress should continue to make investments in
programs that are proven to promote adolescent health by increasing
young people's access to medically accurate and age-appropriate sexual
health information that they need to make safe and healthy decisions.
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\3\ Centers for Disease Control and Prevention. School Health
Profiles 2018: Characteristics of Health Programs Among Secondary
Schools. Atlanta: Centers for Disease Control and Prevention; 2019.
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Since fiscal year 2010 (FY10), the Teen Pregnancy Prevention
Program (TPPP) has supported projects and programs that deliver
community-driven, evidence-based or informed, medically accurate, and
age-appropriate approaches that incorporate involvement from parents,
educators, and health providers. Beginning in 2015, 84 organizations in
33 states, the District of Columbia, and the Marshall Islands were
awarded TPPP funds to replicate evidence-based programs in communities
with the greatest needs; conduct rigorous evaluation of new and
innovative approaches to prevent unintended teen pregnancy; or build
capacity to support implementation of evidence-based programs. The
positive outcomes of the program have been well-documented. In
September 2017, the bipartisan Commission on Evidence-Based
Policymaking, established by then-House Speaker Paul Ryan and Senator
Patty Murray, highlighted TPPP as a model example of a federal program
that has developed evidence in support of good policy.
Planned Parenthood urges you to increase TPPP funding to $150
million. This $49 million funding increase from FY21 to FY22 is
partially offset by eliminating $35 million for discretionary sexual
risk avoidance (SRA) grants. Additionally we urge you to support $6.8
million for dedicated evaluation transfer authority, and ask that
$900,000 of the $6.8 million in Public Health Service Act funding for
``Evaluation of Teen Pregnancy Prevention Approaches'' be allocated
specifically to reactivate the Teen Pregnancy Prevention Evidence
Review. Furthermore, urge you to eliminate funding for the abstinence-
only-until-marriage ``sexual risk avoidance'' competitive grant
program.
The CDC's Division of Adolescent and School Health (DASH) provides
funding to local education agencies across the country to implement
school-based programs and practices designed to prevent HIV and other
STIs among young people, and also integrates approaches aimed at
substance use and violence prevention. In addition, the program expands
the research and evidence base of how to best meet the respective needs
of young people, including LGBTQ youth and other adolescents.
Currently, DASH provides funding to 28 school districts across the
country. Providing a significant increase ($66 million over the FY21
enacted level) to DASH funding would considerably expand the number
served through this important program. We ask that you provide CDC/DASH
with $100 million in FY22.
4. Eliminating Harmful and Discriminatory Policy Riders That Undermine
Access to Abortion and Reject Any New Anti-Sexual and
Reproductive Health Provisions
Opponents of sexual and reproductive health and rights have long
used the appropriations process to undermine access to comprehensive
reproductive care, including access to abortion. Through policy riders
in bills under the jurisdiction of multiple subcommittees, including
the original Hyde Amendment in the Labor/HHS bill, opponents have
limited access for women on Medicaid, women who work for the federal
government, women in prison, and others, including women living in the
District of Columbia, which is even prohibited from spending non-
federal funds on these services. Separately, the Weldon Amendment has
been used to interfere with policies that expand abortion coverage and
access, emboldening health entities to refuse to provide, cover, pay
for, or refer for abortion services.When elected officials deny certain
categories of women insurance coverage for or access to abortion, they
either are forced to carry the pregnancy to term or pay for care out of
their own pockets or simply do not get the care they need. The result
is unfair and discriminatory policy that further exacerbates poor
public health outcomes for those who already face significant barriers
to care, such as low-income women, immigrant women, young women, and
women of color. We urge the Committee to eliminate all such
restrictions on access to abortion.
In addition, the Committee should reject any harmful new policy
riders we have seen proposed in years past that would roll back
progress, including proposals to ``defund'' Planned Parenthood.
********
PPFA issues these requests in the hopes that we can protect and
build upon federal investments to make quality reproductive health care
affordable and accessible so that women and their families can lead
healthier lives. We welcome the opportunity to discuss these requests
with you or your staff. If you have questions about any of the above
requests, please don't hesitate to contact me at
([email protected]). For more information about domestic
priorities, please contact Jack Rayburn, Director, Legislative Affairs
at ([email protected]).
Sincerely.
[This statement was submitted by Jacqueline Ayers, Vice President
of Public
Policy and Government Affairs, Planned Parenthood Federation of
America.]
______
Prepared Statement of the Population Association of America/
Association of Population Centers
Thank you, Chair Murray and Ranking Member Blunt for this
opportunity to express support for the National Institutes of Health
(NIH), National Center for Health Statistics (NCHS), Institute of
Education Sciences (IES), and Bureau of Labor Statistics (BLS). These
agencies are important to the members of the Population Association of
America (PAA) and Association of Population Centers (APC) because they
provide direct and indirect support to population scientists and the
field of population, or demographic, research overall. In FY 2022, we
urge the Subcommittee to adopt the following funding recommendations:
$46.1 billion, NIH; $200 million, NCHS; $700 million, IES; and $800
million, BLS. In addition, we urge the subcommittee to accept report
language, previously submitted, regarding population research programs
and surveys supported by the National Institutes of Health.
national institutes of health
Demography is the study of populations and how or why they change.
The health of our population is fundamentally intertwined with the
demography of our population. Recognizing the connection between health
and demography, NIH supports population research programs primarily
through the National Institute on Aging (NIA) and the National
Institute of Child Health and Human Development (NICHD). PAA and APC
thank Chair Murray and Ranking Member Blunt for their bipartisan
leadership and for working together in recent years to provide the NIH
with robust, sustained funding increases. As members of the Ad Hoc
Group for Medical Research, PAA and APC recommend the Subcommittee
continue to prioritize NIH funding by endorsing an appropriation of at
least $46.1 billion for the NIH, a $3 billion increase over the NIH's
program level funding in FY 2021. We urge that NIA and NICHD, as
components of the NIH, receive commensurate funding increases in FY
2022.
national institute on aging
The NIA Division of Behavioral and Social Research (DBSR) is the
primary source of federal support for basic population aging research.
The NIA Division of Behavioral and Social Research (DBSR) supports a
scientifically innovative population aging research portfolio that
reflects some of the Institute's, and nation's, highest scientific
priorities including Alzheimer's disease and social inequality in
health and the aging process. With additional support in FY 2022, DBSR
could expand its existing research portfolio to encourage more research
on the short and long-term social, behavioral, and economic health
consequences of COVID on older people and their families. The
population research community is especially eager to see NIA use
existing large-scale, longitudinal and panel surveys, such as the
Health and Retirement Study, the National Health and Aging Trends
Study, and Understanding America Study, to facilitate scientific
research on the complex, multifaceted effects of the pandemic on older,
diverse populations. Further, the field believes NIA should sustain its
support for developing data infrastructure to promote research on
racial, ethnic, gender and socioeconomic disparities in health and
well-being in later life and the long-term effects of early life
experiences. With additional funding in FY 2022, DBSR could support
these activities as well as fully fund the NIA Centers on the
Demography and Economics of Aging, which are conducting research on the
demographic, economic, social, and health consequences of U.S. and
global aging at 12 universities nationwide.
eunice kennedy shriver national institute on child health and human
development
Since the Institute's inception in 1962, NICHD has had a clear
mandate to support a robust research portfolio focusing on maternal and
child health, the social determinants of health, and human development
across the lifespan. The NICHD Population Dynamics Branch meets this
mandate by supporting innovative and influential population science
initiatives, including: (1) large-scale longitudinal surveys, with
population representative samples, such as The National Longitudinal
Study of Adolescent to Adult Health and Fragile Families and Child Well
Being Study; (2) a nationwide network of population science research
and training centers; and, (3) numerous scientific research initiatives
that have advanced our understanding of specific diseases and
conditions, including obesity, autism, and maternal mortality, and,
further, how socioeconomic and biological factors jointly determine
human health. Given the dearth of data being collected regarding the
short and long-term social, economic, developmental, and health effects
of the COVID pandemic on children and families, the field of population
research urges NICHD to consider expanding data collection through
existing surveys and the NICHD Population Dynamics Centers Research
Infrastructure Program. Further, population scientists encourage NICHD
to explore the use of existing and new mechanisms to enhance research
regarding the effects of COVID on fertility trends and reproductive
health overall. With additional funding in FY 2022, the Institute could
sustain its existing population research activities as well as
implement our field's recommended COVID related research expansions.
national center for health statistics
NCHS is the nation's principal health statistics agency, providing
data on the health of the U.S. population. Population scientists rely
on large NCHS-supported health surveys, especially the National Health
Interview Survey and National Health and Nutrition Examination Survey,
to study demographic, socioeconomic, and behavioral differences in
health and mortality outcomes. They also rely on the vital statistics
data that NCHS releases to track trends in fertility, mortality, and
disability. NCHS health data are an essential part of the nation's
statistical and public health infrastructure. In order for NCHS to
continue monitoring the health of the American people and to allow the
agency to make much-needed investments in the next generation of its
surveys and products, PAA and APC, as a member of the Friends of NCHS,
recommends the agency receive $200 million in FY 2022. In addition, our
organizations urge the Subcommittee to reiterate its support for the
agency's participation in the Centers for Disease Control (CDC) Data
Modernization Initiative (DMI). The CDC should be encouraged to provide
NCHS with a greater share of the agency's DMI funding--especially given
NCHS has received less than 4 percent of the $600 million that DMI has
received since FY 2020. NCHS should be benefitting from DMI funds, as
the Committee intended, and applying them to make long overdue and
necessary systematic and technological upgrades as well as facilitating
enhanced use of Electronic Health Records.
bureau of labor statistics
Population scientists who study and evaluate labor and related
economic policies use BLS data extensively. The field also relies on
unique BLS-supported surveys, such as the American Time Use Survey and
National Longitudinal Surveys, to understand how work, unemployment,
and retirement influence health and well-being outcomes across the
lifespan. As members of the Friends of Labor Statistics, PAA and APC
are very grateful for $40 million programmatic increase that BLS
received in FY 2020 and for maintaining the agency's funding level in
FY 2021. We are also pleased that BLS received $10 million in FY 2020,
and report language in FY 2021, to plan for a new youth cohort for the
National Longitudinal Survey of Youth (NLSY). As the Subcommittee
knows, the current NLSY 1979 and 1997 cohorts cannot provide adequate
information about teens and young adults entering the labor market. PAA
and APC hope that this planning process will provoke a new, necessary
NLSY cohort. We urge the Subcommittee to give the agency increased
support in FY 2022 by providing BLS with $800 million and to adopt,
once again, report language urging the agency to maintain its plans for
a new NLSY cohort.
institute of education sciences
The Institute of Education Sciences (IES) plays a critical role in
supporting research used in developing and examining the effectiveness
of education programs and curricula. The National Center for Education
Statistics (NCES), the statistical arm of IES, provides objective data,
statistics, and reports on the condition of education in the U.S.
Population scientists rely on NCES surveys to conduct research on
topics, such as linkages between educational access/attainment to
health outcomes of specific populations, economic well-being, and
incarceration rates. The field is pleased NCES is ramping up a new
School Pulse Survey (SPS), to begin in August, that will collect data
on how schools are adapting during the recovery phase of the pandemic.
PAA continues to be concerned, however, that NCES has inadequate
staffing to effectively manage the agency's broad array of surveys and
other data collection and evaluation programs, and to maintain data
quality and program rigor--particularly as it takes on new initiatives
such as SPS. Years of staff attrition combined with bureaucratic
hurdles have hindered the agency's ability to replace key personnel and
maintain an adequate staffing level. We urge the Committee to continue
to exert careful oversight of this situation.
Thank you for considering our support for these agencies as the
Subcommittee drafts the FY 2022 Labor, Health and Human Services and
Education Appropriations bill.
______
Prepared Statement of the Port Gamble S'Klallam Tribe
_______________________________________________________________________
Requests and Recommendations:
1. Increase in funding for the Tribal Opioid Response grant program
to a minimum of $75 million;
2. Increase in funding for the Temporary Assistance for Needy
Families Program to a minimum of $17.8 billion;
3. Increase in funding for the Child Support Program to a minimum
of $4.424 billion;
4. Increase in funding for the Head Start Program to a minimum of
$17.8 billion;
5. Increase in funding for the Child Care and Development Block
Grant to a minimum of $7.3 billion; and
6. Increase in funding for the Low-Income Home Energy Assistance
Program to a minimum of $3.85 billion and a tribal set-aside.\1\
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\1\ We also support the National Congress of American Indians' FY
2022 budget requests. See NCAI, Indian Country FY 2022 Budget Request:
Restoring Promises, https://www.ncai.org/resources/ncaipublications/
NCAI_IndianCountry_FY2022_BudgetRequest.pdf.
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_______________________________________________________________________
introduction
The Port Gamble S'Klallam Tribe is a sovereign Indian nation
comprised of over 1,342 citizens located on the northern tip of the
Kitsap Peninsula in Northwest Washington State. The 1855 Point No Point
Treaty reserved hunting, fishing, and gathering rights for our Tribe,
and the United States agreed to respect the sovereignty of our Tribe
and to protect and provide for the well-being of our Tribe. The United
States, therefore, has both treaty and trust obligations to protect our
lands and resources and provide for the health and well-being of our
citizens. The current COVID-19 pandemic has necessitated the need for
more resources and services to provide for the health, safety, and
welfare of our tribal citizens as well as American Indian and Alaska
Native (AI/AN) people across the United States.
Overarching Comments. Thank you for your commitment to honor and
uphold the United States' trust and treaty obligations, strengthen the
government-to-government relationship between the United States and
tribes, and empower tribes to govern their own communities and make
their own decisions. As you know, federal programs and services are
critical components of building strong tribal governments, economies,
and communities. We look to the Subcommittee to help address the
chronic underfunding of unmet federal obligations and duties owed to
Indian Country. This includes providing funding and support for the
delivery of reliable and quality health care to AI/AN people, ensuring
tribal communities are safe and secure, and expanding economic
opportunity and community development in tribal communities. We ask the
Subcommittee to support increased funding for critical Indian programs
and the inclusion of helpful report language on many significant issues
impacting Indian Country.
Funding for Tribal Health Care. Appropriations to support health
care services are needed to, among other things, address the
significant health disparities that persist among AI/AN people, treat
chronic diseases that plague tribal communities, update and improve
tribal health clinics, and modernize equipment and health information
technology within Indian Country. Our Tribe has administered health
services to its members for several years, and was one of the first
tribes to join the Tribal Self-Governance Project in 1990. We are the
only Indian health care provider of both primary and behavioral health
services in Kitsap County. Our health programs aim to provide the
highest quality medical care and treatment to individuals within our
tribal community, but we still face significant challenges related to
funding, facilities, and program administration. Due to the COVID-19
pandemic, our health programs have run short of resources and need
additional funding to support the services we provide. To strengthen
our health programs, we ask for the following in the FY 2022
appropriations:
Tribal Opioid Response. We appreciate the President's proposed
funding of $75 million to the Tribal Opioid Response grant program, but
more is needed. This program to critical to address the opioid
substance use needs in tribal communities. Indian Country, including
our Tribe's Reservation, has been severely affected by the opioid
epidemic. Increased funding for the Tribal Opioid Response grant
program will address increasing rates of opioid dependence, overdose,
and other negative consequences stemming from opioid use. Funding is
essential to combat the opioid crisis that imposes threats to Indian
Country.
Temporary Assistance for Needy Families (TANF). We support the
President's FY 2022 request of $17.8 billion to support the TANF
Program, which would be an increase in $600 million over FY 2021. The
TANF Program is a capped entitlement program that has continued to
receive the same funding level since it was established. The Tribe
strongly encourages reauthorization of the TANF Program with higher
funding levels in order to provide temporary assistance and economic
self-sufficiency for children and families. The Tribe currently
receives $516,680 from the TANF Program to support its members and
strongly encourages a continuation of at least this amount. However,
there remains an unmet need to operate programs for the benefit of low-
income families. These programs are necessary for the United States to
fulfill its trust responsibility and contribute to the overall well-
being of the Tribe's members.
Child Support Program. We reject the President's request to reduce
funding for the Child Support Program by $233 million to a total of
$4.16 billion. Instead, funding for the Program should be at $4.424
billion, the FY 2020 level. The Tribe operates a robust Child Support
Program. The Tribe's Child Support Program has a need of $781,955 to
enhance its services offered to children with need and to improve
activities offered to children, including an increase of staff members,
support staff training, child counseling, and ensuring that the
physical environments of the Tribe's Head Start Program is conducive to
providing effective program services, increased hours of operation,
improved strategic planning for the program, and safe transportation of
children in the program safely, An increase in funding for the Child
Support Program would allow the Tribe to increase and enhance services
to its members. Any decrease in the level of funding for the Child
Support Program would cause hardship to the Tribe's members.
Head Start Program. We support the President's request of $11.9
billion for the Head Start Program-an increase of $1.2 billion over the
FY 2021 enacted level. The Head Start Program promotes the school
readiness of our tribal youth as well as early learning and
development, health, and family well-being of children from low-income
families. Funding from the Head Start Program greatly assists the Tribe
in offering competitive wages to its employees in its Early Head Start
Program. The Tribe needs additional funding over and above its current
funding to pay its teachers to ensure equitable wages that support Head
Start Performance Standard Regulations. Such funding will also help the
Tribe recruit and maintain teachers and teaching assistants, which is
critical to our education programs and the children the Tribe serves.
The Tribe estimates that it needs at least $235,000 to be able to offer
competitive wages to its program employees. In addition, the Tribe
would like to invest $18,000 in an outdoor learning environment and
$75,000 to support Head Start Program Performance Standards. Indigenous
learning is based on outdoor environments that reflect tribal culture.
The Tribe is in need of funds to plan and develop an outdoor learning
environment to support exploration and discovery in forest/beach/
wetland/stream. Lastly, the Tribe requests an increase in quality
improvement funds to support our students, staff, and families based on
community need.
Child Care and Development Block Grant. Our Tribe supports the
President's request for providing $7.3 billion in discretionary funds
for the Child Care and Development Block Grant. This program supports
low-income, working families within our Tribe by providing access to
affordable, high quality child care. Adequate child care is essential
for our tribal members. The pot of child care money going to Tribal
governments from this program needs to be bigger so that the portions
of it that Tribes receive can meet their needs. The overall funding
amount for the Child Care Development Fund needs to be increased and
Tribes should get a 5% set-aside from it. Indian Country, including our
Tribe, have a strong need to access the Fund for facility purposes. An
increase in funding for the Child Care and Development Block Grant
would allow the Tribe to increase and enhance services intended to
serve its youth.
Low-Income Home Energy Assistance Program (LIHEAP). We appreciate
the President's request to increase funding for the LIHEAP Program by
$100 million for a total of $3.85 billion. The LIHEAP Program assists
low-income households to pay a proportion of household income for home
energy, primarily in meeting their immediate home energy needs.
Currently, the Tribe receives $23,979 from LIHEAP to assist its
members, but there continues to be an unmet need. The Tribe requests an
increase in LIHEAP funding to assist our tribal members in paying their
home energy bills. Any decrease or in the current level of funding in
the LIHEAP Program would cause significant hardship to the Tribe's
members. We also request that a tribal set-aside for the LIHEAP Program
be established.
conclusion
Thank you for the opportunity to share our interests regarding FY
2022 appropriations for programs and services that will greatly benefit
us as well as other tribes across the United States. On behalf of the
Port Gamble S'Klallam Tribe, we thank you and your dedication and
continued hard work in protecting the tribal interests. We know that
you will be fighting for Indian Country in the appropriations process.
[This statement was submitted by Jeromy Sullivan, Chairman, Port
Gamble S'Klallam Tribe.]
______
Prepared Statement of Public Health-Seattle & King County, WA
Chair Murray, Ranking Member Blunt, and members of the
Subcommittee, my name is Brad Finegood and I work for King County (WA)
as a Strategic Adviser for Public Health-Seattle & King County in
Seattle, WA.
I am pleased to submit testimony on behalf of King County, WA to
urge Congress to appropriate $120 million for the Infectious Diseases
and the Opioid Epidemic program at the Centers for Disease Control and
Prevention (CDC) at the Department of Health and Human Services (HHS)
to save lives and address the overdose crisis by supporting and
expanding access to syringe services programs (SSPs).
King County, WA is seeing an unprecedented surge in overdose
deaths. In 2020, there were 510 confirmed overdoses in the county,
which is more than the 422 experienced in 2019. There has been a year
over year rise over the past decade when there were 245 overdose
fatalities in 2011. The majority of the drug overdoses include opioids,
although a rising number of overdoses also contain stimulants both
alone and in polysubstance use overdoses. Our county is also besieged
by fentanyl rising from 3 fentanyl related overdose deaths in 2015, to
172 in 2020 with 135 confirmed fentanyl overdoses already in 2021 (as
of date authored). We know that access to sterile use equipment is one
of the evidence-based interventions that keeps individuals engaged in
health services, decreases the likelihood of transmissible diseases and
keeps individuals alive.
The United States is experiencing an urgent and unprecedented drug
overdose crisis, with more than 100,000 overdose deaths expected to be
counted in 2020 and potentially more in 2021. Overdose deaths are
expected to have increased by more than 40% than the previous record
year of 2019. According to the Washington Department of Health,
overdose deaths accelerated in Washington in 2020, increasing by 38% in
the first half of 2020 compared to the first half of 2019. The
infectious diseases associated with opioid and other drug use also have
dramatically increased. Since 2010, the number of new hepatitis C
infections has increased by 380%. Outbreaks of viral hepatitis and HIV
among people who inject drugs continue to occur nationwide.
Overdose deaths have increased more dramatically among Black people
and communities of color. From 2015 to 2018, overdose deaths among
African Americans more than doubled (by 2.2 times) and among Hispanic
people increased by 1.7 times while increasing among white, non-
Hispanic people by 1.3 times. In Washington, the increase in overdose
deaths was highest among groups already dealing with inequitable health
outcomes: American Indian/Alaska Natives, Hispanic/Latinx, and Black
people.
SSPs are an essential component of preventing overdose deaths.
Tacoma Needle Exchange proudly services clients, who can exchange their
used injection supplies for sterile syringes, which helps prevent the
spread of blood-borne pathogens like HIV. Other services include safe
injection supplies, naloxone training and distribution, safer sex
supplies, and referrals for medication assisted treatment and other
medical services. Our outreach staff attempts to meet people where they
are at, and to help them address their needs in the safest and
healthiest way possible, free of judgement and stigma.
Congress must respond to the overdose crisis, as well as work to
prevent and reduce infectious diseases related to drug use, such as HIV
and hepatitis C by supporting and expanding access to syringe services
programs (SSPs). The CDC has documented over 30 years of studies that
show that SSPs reduce overdose deaths and infectious diseases
transmission rates as well as increase the number of individuals
entering substance use disorder treatment. These studies also confirm
that SSPs do not increase illicit drug use or crime and save money.
SSPs are among the only health care services trusted and used by
people who use drugs and so can effectively engage this highly
stigmatized population. SSPs help protect the community (including
first responders) by ensuring safe disposal of syringes, reducing rates
of infectious diseases, and can help providing a pathway to effective
mental health and alcohol and other drug treatment and to other medical
care.
SSPs are the most effective way to get naloxone--a drug which
reverses an opioid overdose--into the hands of people who use drugs,
who are most likely to be at the scene of an overdose. People who use
drugs are an essential partner in preventing overdose fatalities and
are best reached by SSPs. With additional resources, SSPs can reach
more people with naloxone, which would help reduce the dramatically
increasing number of overdose deaths.
Unfortunately, the nation has insufficient access to SSPs and the
COVID-19 pandemic has decreased access to these life-saving services
during a time when the need for services has increased dramatically. In
January 2021, Drug Policy Alliance conducted a survey of SSPs that
showed that 91% of respondents experienced an increase in clients in
2020, many as a result of the COVID-19 pandemic. During this time of
skyrocketing need, 42% of respondents experienced funding cuts in 2020
and expect such shortfalls to continue in 2021. As a response to
funding shortfalls, many SSPs have been forced to lay off staff and
reduce services. In King County service availability has been limited
so individuals experienced limited access to life saving interventions
like needle exchange and naloxone. Consequently, because of these
decreased and limited resources, SSPs cannot reach the millions of
people who may benefit from their life-saving services.
Federal funding would expand access to these critical and effective
programs. Tacoma, WA's NASEN's statistics show that there are only
approximately 400 SSPs operating nationwide. Experts estimate that to
sufficiently expand access to SSP programs, the U.S. would require at
least 2,000 programs--5 times the number in existence now.
A recent study that assessed the startup costs of an individual
program estimated that it would cost (in 2020 dollars) $490,000 for a
small rural program and $2.1 million for a large urban program,
resulting in an average start-up cost of $1.3 million per program.
Based on these numbers the requested funding would provide an 10%
increase to currently operating SSPs to help address funding shortfalls
and also expand the number of SSPs nationwide.
Finally, expanding access to SSPs will reduce health care costs,
including for infectious diseases treatment. Hepatitis C treatment can
cost more than $30,000 per person, while HIV treatment can cost upwards
of $560,000 per person. Averting even a small number of cases would
save millions of dollars in treatment costs in a single year.
The Infectious Diseases and Opioid Epidemic Program at CDC helps to
eliminate infections related to injection drug-use and improve their
prevention, surveillance, and treatment. It also strengthens and
expands access to syringe services programs. In FY2019, CDC began
several projects to expand capacity of SSPs nationwide through
technical assistance to ensure high-quality, comprehensive services and
best practices. With additional FY22 funding, CDC could significantly
expand SSPs at this critical time to help prevent overdose deaths, the
spread of HIV and viral hepatitis and connect people to life-saving
medical care.
On a personal note--in addition to leading the overdose prevention
work for King County, I am the brother of overdose victim. Every single
person who counts as a fatal overdose is a family member to someone and
an individual that could have been saved. We have the tools; we just
need the funding to help implement.
I want to thank the Subcommittee for its past funding of the CDC
Infectious Diseases and Opioid Epidemic program and urge Congress to
provide $120 million for the program in FY22. Thank you also for your
time and consideration of my testimony, and please do not hesitate to
contact me at [email protected] if you have questions or
need additional information.
Sincerely.
[This statement was submitted by Brad Finegood, MA, LMHC, Strategic
Adviser, Public Health-Seattle & King Co., King County, WA.]
______
Prepared Statement of the Pulmonary Hypertension Association
pha's fiscal year 2022 l-hhs appropriations recommendations
_______________________________________________________________________
--At least $46.1 billion in program level funding for the National
Institutes of Health (NIH).
--Proportional funding increases for NIH's National Heart, Lung,
and Blood Institute (NHLBI); the National Institute of
Child Health and Human Development (NICHD), and the
National Center for Advancing Translational Sciences
(NCATS).
_______________________________________________________________________
Chairwoman Murray, Ranking Member Blunt and distinguished members
of the Subcommittee, thank you for your time and your consideration of
the priorities of the pulmonary hypertension (PH) community as you work
to craft the FY2022 L-HHS Appropriations bill.
about pulmonary hypertension
Pulmonary hypertension (PH) is high blood pressure that occurs in
the arteries of the lungs. It reflects the pressure the heart must
apply to pump blood from the heart through the arteries of the lungs.
As with a tangled hose, pressure builds up and backs up forcing the
heart to work harder and less oxygen to reach the body. PH symptoms
generally include fatigue, dizziness and shortness of breath with the
severity of the disease correlating with its progression. If left
undiagnosed or untreated it can lead to heart failure and death. In
recent years, innovative treatment options have been developed and
approved for PH. The effectiveness of current treatment options depends
on accurate diagnosis and early intervention.
about pha
Headquartered in Silver Spring, Md., the Pulmonary Hypertension
Association (PHA) is the country's leading PH organization. PHA's
mission is to extend and improve the lives of those affected by PH. PHA
achieves this by connecting and working together with the entire PH
community of patients, families, health care professionals and
researchers. The organization supports more than 200 patient support
groups; a robust national continuing medical education program; a PH
clinical program accreditation initiative; and a national observational
patient registry.
health resources and services administration
Due to the serious and life-threatening nature of PH, it is common
for patients to face drastic health interventions, including heart-lung
transplantation. To ensure HRSA can continue to make improvements in
donor lists and donor-matching please provide HRSA with an increase in
discretionary budget authority in FY2022.
national institutes of health
Please provide NIH with meaningful increases--including at least
$46.1 billion in program funding in FY2022--to facilitate expansion of
the PH research portfolio and continued improvement in diagnosis and
treatment. NHLBI and PHA have partnered on a groundbreaking clinical
study, the Redefining Pulmonary Hypertension through Pulmonary Vascular
Disease Phenomics (PVDOMICS) program (RFA-HL-14-027 and RFA-HL-14-030).
By collecting information from nearly 1,200 participants with various
types of PH, subjects at risk for PH, and healthy controls, PVDOMICS
hopes to find new similarities and differences between the current WHO
classifications of PH. This research is intended to lead to
identification of both endophenotypes of lung vascular disease and
biomarkers of disease that may be useful for early diagnosis or for
assessment of interventions to prevent or treat PH.
Data from the original cohort is currently being prepared for
publication and the rich resources of PVDOMICS have spurred many
presentations at national and international meetings. With its novel
approach to enrollment and data analysis, PVDOMICS is poised to change
our thinking about pulmonary hypertension and its classification in the
upcoming years.
proper health coverage and access
The PH community is concerned that the Centers for Medicare and
Medicaid Services (CMS) is allowing insurance payers to refuse to
accept charitable copay and premium assistance on behalf of patients
with complex, chronic and life-threatening conditions like PH. Because
of breakthroughs in research, PH patients are able to utilize life-
sustaining treatments that allow them to manage this potential fatal
condition and lead relatively normal lives. When patients are denied
access to financial assistance they are forced to choose between
necessities: between dramatically shortening their lives by giving up
medication in order to afford housing and food or continuing medication
while starting their families on the road to bankruptcy. We aware of
the Subcommittee's continued requests for an explanation of this
practice targeting rare disease patients. We ask that this Subcommittee
once again ask CMS to explain this decisions and encourage them to fix
this problem that is greatly affecting the rare disease community.
PHA also asks the Subcommittee to urge CMS to increase incentives
for the supply of oxygen that affects all oxygen modalities including
both liquid and portable supplies. This increased flexibility will
increase patient's quality of life at home and in their communities.
patient perspectives
Chandani's three-year-old son was diagnosed with severe PH in July
2020 at the age of two. Chandani is a physician herself and so she
understands all too well the seriousness of her son's prognosis. Since
his diagnosis last year, her son's medical care team has tried
progressively increasing therapies in a stepwise fashion, which is
often required by insurance companies but is known to lead to worse
outcomes than when patients are allowed to immediately begin the
treatment prescribed by their doctor.
Currently, Chandani's toddler is receiving three oral drugs in
addition to a subcutaneous infusion, all for PH. As of the end of
April, he has not been responsive to these therapies which
unfortunately indicates a poor prognosis. Currently, without a
transplant, her son has a 60% chance of survival over the next five
years, and if he were to receive a double-lung transplant, it would
statistically add 2.7 years to his life. Studies show that self-
reported quality of life for patients with pulmonary hypertension ranks
worse than cancer patients. Research and treatment are vitally needed
for this disease that has such a fatal prognosis and a poor quality of
life.
Denise has a health insurance plan with a $3,000 deductible. She
uses a manufacturer copay card to pay for the first of her life-
sustaining pulmonary hypertension (PH) medications. However, Denise's
health insurance plan will not apply the copay card to her deductible,
so when Denise fills the prescription for her second medication, she is
responsible for her entire deductible out-of-pocket. When Denise was
renewing her health insurance coverage for the year, this information
was hidden from her. She was told about other changes to the plan, but
the shift to a copay accumulator was never mentioned, nor could Denise
find the relevant information online.
Barbara has lived with PH for 21 years and with the treatment of
liquid oxygen, she has managed to develop a comparatively active life
filled with volunteer work and visits with her children and
grandchildren. However, that changed in April 2021 when Barb's
Medicare-contracted oxygen supplier stopped delivering liquid oxygen
without notice. Instead, they began providing compressed oxygen gas
tanks.
Liquid oxygen tanks are light enough to be carried hands-free
strapped to the back and hold a sufficient volume of oxygen to provide
a continuous stream for 6-8 hours at a time so that Barb is able to
breathe easily while still walking around. By contrast, compressed
oxygen tanks are heavier and hold a smaller volume of oxygen, so they
sustain her for only a fraction of the time that liquid oxygen tanks
do. To carry a compressed oxygen tank with her, she must wheel it
behind her or struggle with the weight and bulk of the tank if
attempting to carry them on her back and change them out every couple
of hours.
These new limitations to her lifestyle due to the loss of
appropriate treatment for her PH have caused a steep decline in her
mood and quality of life and she has quickly become depressed; at a
recent visit with her physician, she was told ``I've never seen you
this bad.'' The mobility and ease that using a liquid oxygen tank
provides Barb is the difference between struggling to complete one
errand in a day, versus running multiple errands, feeling capable of
going out to have lunch with friends, or being able to comfortably
visit her seven grandchildren.
In the past weeks, Barb has spent precious energy calling 30
suppliers within a 100-mile radius of her home searching unsuccessfully
for anyone else to provide her with the correct treatment for her PH
condition. In her efforts to find out more about the loss of access to
liquid oxygen, Barb has heard from many other PH patients from across
the country who are experiencing the same situation. This restriction
of access to liquid oxygen represents a collective loss in quality of
life for the community of PH patients that could have long-lasting and
far-reaching consequences for an already serious, degenerative disease.
Thank you again for your consideration of the PH community's
priorities as you develop the FY2022 L-HHS Appropriations bill.
[This statement was submitted by Matt J. Granato, LL.M., MBA,
President and CEO, Pulmonary Hypertension Association.]
______
Prepared Statement of Reamer Andrew deg.
Prepared Statement of Andrew Reamer
I write to request that the report of the Senate Committee on
Appropriations accompanying appropriations legislation for Labor,
Health and Human Services, Education, and Related Agencies include
language that directs the Bureau of Labor Statistics (BLS), U.S.
Department of Labor, to provide memoranda to the Subcommittee, and to
the Senate Committee on Health, Education, Labor, and Pensions,
regarding the following topics:
--Approaches to accurately measuring the extent and nature of
telework and remote work in the United States, by geography and
industry, with the implications for future appropriations.
--Approaches to creating a new principal federal economic indicator
on well-being, with implications for future appropriations.
--Possible impacts of the Census Bureau's new Disclosure Avoidance
System on BLS data derived from Census Bureau statistics and
used to determine the allocation of federal financial
assistance to states, local areas, and households.
I provide information below in support of this request. I write as
a research professor at the George Washington Institute of Public
Policy, George Washington University, with a focus on the role of the
federal government in facilitating national economic development and
competitiveness.
Measures of Telework and Remote Work. News reports make clear that
the pandemic has catalyzed a substantial increase in the number of
employees who telework from home in lieu of commuting to an office and
those who work from a geographic location different than the office to
which they report. For the purposes of public policy and business
decision-making, BLS statistics should provide reliable estimates of
telework and remote work by geography and industry.
My research (available here) identifies 14 federal data collections
that independently measure the extent and nature of remote work. Eight
collected such data before the pandemic; six added telework questions
in response to the pandemic. Six are household surveys, six are
establishment surveys, and two prepare occupational profiles. Six are
conducted by BLS, five by the Census Bureau, and one each by the
Employment and Training Administration, the Federal Highway
Administration, and the Office of Personnel Management.
While BLS and other federal agencies are to be lauded for their
proactive efforts, it would be desirable to rationalize the plethora of
data collections so that BLS may point to a single data series as the
most appropriate measure. The choice made will have implications for
future appropriations. Consequently, I recommend that the Senate
Appropriations Committee report accompanying Labor Department
appropriations legislation include a directive that BLS provide the
Subcommittee with its views on the preferred approach to measuring
telework and remote work and resource requirements to implement it.
Measures of Well-being. Numerous scholars, such as Carol Graham of
the Brookings Institution and Angus Deaton and Anne Case of Princeton
University, demonstrate through their research the significant increase
in despair and deaths of despair, particularly among the white working
class. As with telework, several federal agencies are independently
seeking to measure the extent of and reasons for despair inside
American households and, at present, there is no single reliable,
consensus measure of well-being akin to Principal Federal Economic
Indicators such as the unemployment rate and the poverty rate.
For FY2021, Congress appropriated funds for BLS to conduct the
Well-Being Module of the American Time Use Survey (ATUS). I recommend
that Senate Appropriations Committee report language for FY2022
appropriations direct BLS provide the Subcommittee with its views on
approaches to creating a reliable, useful well-being indicator and the
resources necessary to produce it.
Impacts of Census Differential Privacy Protocols on BLS-guided
Federal Financial Assistance. To ensure adherence to Title 13
requirements for confidentiality, the Census Bureau is implementing a
new Disclosure Avoidance System (DAS) based on differential privacy
protocols that inserts distortions within certain agency datasets while
maintaining system-wide statistical accuracy. BLS labor force and price
statistics rely on Census Bureau data collections that may be affected
by the new DAS; several federal departments use BLS state and local
statistics, such as unemployment rate, to determine program eligibility
and allocate by formula billions of dollars in federal financial
assistance. At the moment, the effect of the new DAS on the geographic
allocation of federal funding is not understood. Consequently, I
encourage the Subcommittee to direct BLS to identify which of its
datasets might be affected by the new Census DAS and, by extension,
which federal funding programs might be affected as well, and how.
Note: I gathered the information contained above through my
sponsored research and as the research organization representative on
the Workforce Information Advisory Council (WIAC) of the U.S. Secretary
of Labor. I submit the above request as a private citizen and not as a
representative of any organization or body.
[This statement was submitted by Andrew Reamer, Research Professor,
George Washington Institute of Public Policy, George Washington
University.]
______
Prepared Statement of Research!America
On behalf of the Research!America alliance, thank you for this
opportunity to submit testimony to the Senate Appropriations
Subcommittee on Labor, Health and Human Services, Education, and
Related Agencies on Fiscal Year 2022 (FY22) appropriations. We are
grateful that for FY21, the base budgets of the National Institutes of
Health (NIH) and the Centers for Disease Control and Prevention (CDC)
were increased and the base budget of the Agency for Healthcare
Research and Quality (AHRQ) was maintained, and that the Subcommittee
additionally provided dedicated funding for critical research programs.
The need for faster medical and public health progress has never been
more apparent. Our nation has an opportunity, and on behalf of every
American, the obligation, to fight health threats faster, learn from
this pandemic to bolster public health capacity and preparedness, and
leverage evidence as never before to optimize health care delivery. In
that context, we ask that you provide an increase in the base budget
(exclusive of new initiatives) for NIH of at least $4.29 billion, for a
total of $47.22 billion; an increase of at least $2.18 billion for CDC,
for a total of $10 billion; and an increase of at least $162 million
for AHRQ, for a total of $500 million, in FY22.
the national institutes of health
We believe it is in the strategic interests of the U.S. to increase
funding for NIH to at least $47.22 billion in FY22, an increase of 10%
over FY21 funding. Our nation and the global community have witnessed
the broadscale impact of a global pandemic, but the reality is that
every American either experiences directly or is the loved one of an
individual who dies prematurely of a health threat that we can
overcome. NIH-conducted and funded research uncovers new knowledge that
is the prerequisite to conquering these threats. No entity, in the U.S.
or across the globe, has done more to propel academic and private
sector progress that saves lives.
NIH funds almost 50,000 competitive grants that are awarded to
researchers at over 500 universities, medical schools, and educational
institutions in every state. NIH also plays an integral role in
educating and training America's future scientists and medical
innovators by sponsoring fellowships and training grants.
We believe our nation should seize the opportunity to change the
course of history such that we can out-innovate emerging threats and
all live longer, healthier lives. Please allocate at least $47.22
billion in FY22 for the base budget of NIH, an increase of 10% over
FY21 funding.
the centers for disease control and prevention
We urge you to fund the Centers for Disease Control and Prevention
(CDC) at a level of $10 billion in FY22, a 27% increase over FY21
enacted. As demonstrated by the ongoing COVID-19 pandemic, public
health threats do not respect international borders, and in our
increasingly globalized world, we are more vulnerable than ever to
emerging, deadly infectious diseases.
CDC is tasked with protecting and advancing the nation's health,
and over the past 70 years it has worked diligently to thwart deadly
outbreaks and debilitating disease. Moreover, CDC plays a key role in
research that leads to life-saving vaccines, bolsters our nation's
defense against and response to bioterrorism, and improves health
tracking and data analytics.
CDC has been an integral part of the effort to mitigate and defeat
COVID-19. Their 24/7 response and the guidance that has emerged from
their efforts has empowered our nation to weather this pandemic, but
their role as the key first responder when major threats emerge is just
part of their contribution to Americans' health, safety, and wellbeing.
CDC is at the forefront of prevention; is working hard and
effectively to forestall antibiotic resistance; is the lead federal
agency responsible for tracking and forestalling foodborne illness and
other local and regional outbreaks; investigates cancer clusters; and
protects, investigates, and advances the health of every one of us in
myriad ways. Our nation has underfunded CDC at risk to every American:
we need to empower this agency to advance the best interests of every
American by protecting and advancing the health of all Americans.
The ongoing COVID-19 pandemic, in addition to past outbreaks of
Ebola, Zika, influenza, and measles, have shown just how critical CDC
is to the health of our nation and have also revealed the enormity of
the challenge the agency faces as it works to safeguard American lives.
To protect us, CDC scientists must be on the ground fighting public
health threats wherever and whenever they occur. We cannot allow a gap
between the funding provided to CDC and the demands and challenges
placed before the agency. We request that CDC receive at least $10
billion in FY22, $2.18 billion over FY21 funding, to ensure the agency
can carry out its crucially important responsibilities.
agency for healthcare research and quality
We urge you to fund AHRQ at a level of $500 million, a 47.9%
increase over FY21 funding, in FY22. AHRQ has been grossly underfunded
for decades relative to its mission and the lives and dollars this
agency could save if appropriately equipped. AHRQ is the lead federal
agency tasked with making sure our nation is not simply making medical
progress, but that this progress translates into more effective,
efficient, and affordable health care for Americans across the country.
As it stands, our nation overspends by an estimated $1 trillion each
year and abides deadly medical errors that cost at least 100,000 lives
each year because we don't deploy strategies to address inefficiencies
and errors in health care. Now is the time to empower AHRQ to address
this massive, counterproductive challenge.
AHRQ-funded research identifies and highlights how to stop waste of
limited health care dollars, empowering patients to receive the right
care at the right time in the right settings. For example, AHRQ-funded
research informed the creation of an Antibiotic Stewardship Program
(ASP) in 402 hospitals across the U.S. to address the overprescription
of antibiotics, which can ultimately lead to them being ineffective.
This research program successfully reduced the length of time patients
needed to be on antibiotic therapy by an average of 30 days. The
research also identified key improvements for future ASPs.
The value of medical discovery and development hinge on smart
health care delivery. If we underinvest in AHRQ, we are inviting
unnecessary health care spending and wasting the opportunity to ensure
patients receive the quality care they need.
We appreciate your consideration of our funding requests and thank
you, and your respective staff members, for your stewardship over these
critically important federal spending priorities.
Sincerely.
[This statement was submitted by Ellie Dehoney, Vice President of
Policy and
Advocacy, Research!America.]
______
Prepared Statement of the Restless Legs Syndrome Foundation
Chairwoman Murray, Ranking Member Blunt, and distinguished members
of the Subcommittee, as you work to develop the fiscal year (FY) 2022
Labor-Health and Human Services Appropriations bill, thank you for
considering the views of the community of physicians, researchers,
patients, and caregivers affected by Restless Legs Syndrome (RLS).
Please keep the needs of this community in mind, especially as you
continue to work to address the opioid crisis.
about the rls foundation
The Restless Legs Syndrome Foundation is a nonprofit Sec. 501(c)(3)
organization dedicated to improving the lives of men, women, and
children living with this often--devastating neurological condition.
The Foundation works to increase awareness, improve treatments, and
support research to find a cure. From a few volunteers meeting in a
member's home in 1992, the Foundation has grown steadily; it now has
members in every state, local support groups, and a track record that
includes nearly $2 million provided to support translational research.
about rls
Restless legs syndrome (RLS) is essentially an irregular biological
drive, like hunger or thirst, that forces affected individuals to keep
moving, thus reducing their ability to rest. Patients with this disease
experience a deep, viscerally-irritating sensation in the legs that
continues to increase until they are literally forced to move their
legs or get up and walk; and this sensation only abates so long as the
individual keeps moving. RLS is best characterized as a neurological,
sensory-motor disorder with symptoms that are triggered from within the
brain itself. It is estimated that up to 5 to 7 percent of the U.S.
population may have RLS, of which half will have moderate to severe
stages of the disease. RLS impacts men, women, and children, though it
is 3 to 4 times more common in women and twice as common in older
Americans.
Due to the inability to sleep and work, RLS can cause disability,
depression, and suicidal ideation, as well as increased risk for co-
morbid conditions such as heart attack, stroke, and Alzheimer's. There
is no cure, and the current standards of care features several
medications, which do not provide life-long coverage. One of the
established effective treatment options for this disease is low--total
daily dose opioid medications. These are commonly used when all other
drug classes have failed. Research and clinical experience indicates
that the dose of opioids typically used to manage RLS effectively
without addiction or drug tolerance issues is significantly lower than
dosages used to treat chronic pain.
fiscal year 2022 appropriations recommendations
The RLS Foundation joins the broader medical research community in
thanking Congress for continuing to support the National Institutes of
Health with sustainable growth. Please continue to advance scientific
progress through proportional funding increases by providing at least a
$3 billion funding increase for FY 2022 to bring NIH's budget up to
$46.1 billion.
In this regard, please provide proportional funding increases for
all NIH Institutes and Centers, including, but not limited to the
National Institute of Neurological Disorders and Stroke (NINDS), the
National Heart, Lung, and Blood Institute (NHLBI), the National
Institute on Drug Abuse (NIDA), and the National Institute of Mental
Health (NIMH). Research on RLS and similar neurological movement
disorders is directly related to efforts targeting the opioid epidemic,
as many patients with these disorders utilize very low total daily
doses of opioid therapies to manage their condition. Additionally,
related sleep disorders research activities impact many conditions and
are studied across various Institutes and Centers at NIH.
Please provide $5 million for the National Neurological Conditions
Surveillance System (NNCSS) for FY 2022. The NNCSS at the Centers for
Chronic Disease Control and Prevention (CDC) collects and synthesizes
data to help increase our understanding of neurological disorders and
to support further neurologic research. RLS remains a severely
misunderstood and underdiagnosed neurological disorder, and increased
surveillance is vital to improving patient outcomes.
Please provide at least $5,000,000 for the Chronic Diseases
Education and Awareness Program at the Centers for Disease Control and
Prevention (CDC). With the cessation of the National Healthy Sleep
Awareness Project (NHSAP), CDC presently has no active public health
activities dedicated to sleep or sleep disorders, despite the fact that
sleep affects nearly every body system and many chronic diseases.
Please allow the valuable scientific and public health efforts started
during the NHSAP to continue.
rls and the opioid crisis
While you consider the Committee's work to address the opioid
epidemic through this fiscal year's appropriations bill, the RLS
Foundation asks that you protect the needs of patient communities who
depend on appropriate access to low total daily doses of opioid
therapies to manage their debilitating condition. RLS is not a chronic
pain condition, and many in our community utilize these medications to
treat underlying neuropathology issues and not sensations of pain.
Studies have shown that appropriate access to these therapies allows
patients to live productive lives without an increased risk of
developing opioid use disorder. As you consider various legislative
proposals and work with federal agencies, please consider the needs of
patients who rely on the regular use of low total daily doses of
opioids to manage RLS by supporting a diagnosis-appropriate safe harbor
for RLS patients, so they do not face arbitrary barriers.
I would like to share with you the experience of Stephen Smith from
Colorado, a RLS Foundation Discussion Board Moderator. Like all those
with RLS, night can bring a feeling of dread. Is this going to be one
of those nights when my RLS acts up and I don't get any sleep or will
it just be one of those standard nights when my sleep is just poor?
About a year ago, I had one of those nights when my RLS acted up
and I knew that I wasn't going to get any sleep at all. So I called my
doctor's night service and was instructed to go to the local hospital's
Emergency Room and to tell them to call my doctor.
Contrary to hospital policy, the ER doctor decided not to call and
also didn't understand RLS or my insomnia complaints. But he jumped on
my depressed feelings from insufficient sleep combined with my RLS
pacing, which he assumed was agitation, and the opioid that I take for
RLS. He then incorrectly concluded I had a drug problem and was
suicidal in spite of being told that I was not. So he placed me under a
72hr psychiatric hold and sent me to a psych hospital 3 hours away. I
was shipped 180 miles confined to the back seat of a car with raging
RLS. The psych hospital didn't carry one of my RLS meds, tramadol, and
forced me to go into withdrawal rather than go to the effort to replace
it. The abrupt withdrawal from tramadol led to hours of shakes and
sweats followed by even more hours of RLS--like pacing for the second
night in a row. Since tramadol also acts as an SNRI anti-depressant,
the abrupt withdrawal caused me to develop SNRI Withdrawal Syndrome.
This caused migraine headaches, severe anxiety and depression,
nightmares and dreams centered on the horrible experience of being
involuntarily confined to the psych hospital due to a neurological
disorder. These symptoms went on for months and required drug treatment
for anxiety and psychotherapy for the severe depression.
So, now nightfall brings a feeling of trepidation. Is this going to
be another night when my RLS acts up or I cannot fall asleep? If I do
manage to sleep, will I once again dream of the nightmare of being
confined to the psych hospital all due to failure of a number of
doctors to understand RLS or to even listen to their patient who is
trying to educate them?
Thank you again for the opportunity to share the views of the RLS
community.
[This statement was submitted by Karla M. Dzienkowski, RN, BSN,
Executive
Director, Restless Legs Syndrome Foundation.]
______
Prepared Statement of Rotary International
Chairwoman Murray, members of the Subcommittee:
Rotary appreciates the opportunity to encourage continuation of
funding for FY 2022 to support the polio eradication activities of the
U.S. Centers for Disease Control and Prevention (CDC). The CDC is a
spearheading partner of the Global Polio Eradication Initiative (GPEI),
an unprecedented model of cooperation among national governments, civil
society and UN agencies which reach the most vulnerable children
through the safe, cost-effective polio immunization. Rotary
International requests the Subcommittee provide $176 million for the
polio eradication activities of the CDC to ensure recovery of polio
eradication progress disrupted by the COVID-19 pandemic, stop polio
transmission, protect polio free areas, and leverage the resources
developed through this global effort for continued value-added impact.
The 300,000 members of Rotary clubs in the US appreciate the United
States' generous support and longstanding leadership. Rotary, including
matching funds from the Gates Foundation, has contributed more than
$2.2 billion and thousands of hours of volunteer service to protect
children from polio; and will continue this work until the world is
certified polio free. Continued US leadership will help achieve a polio
free world and ensure the continued global health contribution of polio
eradication infrastructure and resources.
progress in the global program to eradicate polio
Since the launch of the GPEI in 1988, eradication efforts have led
to more than a 99.9% decrease in cases. Thanks to this committee's
support, over 19 million people have been spared disability, and over
900,000 polio-related deaths have been averted. In addition, more than
1.5 million childhood deaths have been prevented, thanks to the
systematic administration of Vitamin A during polio campaigns.
In 2020, the WHO AFRO region was certified wild polio virus-free
after four years without detecting any cases, making it the fifth of
six WHO regions to eliminate the virus. This achievement follows the
certification of the eradication of Type 3 (WPV3) in October 2019 and
wild poliovirus type 2 (WPV2) in September 2015. The eradication of
wild polio virus from regions and eradication of strains of the polio
virus is further proof that a polio-free world is achievable.
Only two countries, Afghanistan and Pakistan, have confirmed cases
of wild polio since August of 2016. As of 3 June 2021, only 2 cases of
wild polio virus have been confirmed--one each in Pakistan and
Afghanistan. Significant reductions in detection of virus transmission
in environmental samples in 2021 are also cause for cautious optimism.
Both countries are working to capitalize on low levels of virus
transmission by working to reach missed children, prioritizing
communities which have had low coverage or which have been resistant to
immunization; and ensuring thorough microplanning of immunization and
other eradication activities. In Afghanistan, there are increased
efforts to target children living in areas which have been
inaccessible. This ongoing work is challenging within the context of
the NATO withdrawal of troops and related insecurity.
Outbreaks of circulating vaccine-derived poliovirus are ongoing in
several countries across Africa and Asia and require continued focus
and attention. These were further exacerbated by COVID-19 pandemic-
related disruptions in immunization campaigns. These outbreaks are not
a failure of the vaccine, but result from a failure to sustain
sufficiently high levels of routine immunization which causes the live,
but weakened form of the virus used in the vaccine to revert over time
to a more virulent, wild-like form. The program has developed a
specific Strategy for the Response to Type 2 Circulating Vaccine-
Derived Poliovirus, including the use of a new, more genetically stable
vaccine, the novel oral polio vaccine type 2 (nOPV2), for outbreak
response.
The COVID-19 pandemic has posed new challenges for global polio
eradication activities. In order to protect communities and staff, the
Global Polio Eradication Initiative paused immunization campaigns and
other essential activities for several months in 2020. In countries
that have successfully resumed activities, the programme has developed
strategies for prevention and control of COVID-19 and is providing
resources such as masks and hand sanitizer to keep frontline health
workers protected while ensuring that campaign elements meet physical
distancing requirements.
As a result of the pause on activities, and also due to the
potential exposure to COVID, the number of vulnerable children has
increased the real threat for wider spread of the virus. UNICEF, WHO
and Gavi estimate that at least 80 million children under the age of
one are at risk due to the COVID-19 related disruption to vaccination
activities. These challenges are further compounded by the
extraordinary economic and financial constraints in both at-risk
countries and from donors which may divert essential political and
financial commitments.
This combination of progress in the midst of ongoing challenges
underscores the urgency of continued focus to protect the vulnerable
gains made toward polio eradication as the COVID-19 pandemic continues
to disrupt polio immunization and eradication activities; and to stop
polio virus transmission in these most complex environments while
sustaining high levels of population immunity in polio free areas.
Continued support for global surveillance is also essential to monitor
and detect cases and virus transmission and provide confidence in the
absence of cases.
cdc's vital role in global polio eradication progress
The United States is the leader among donor nations in the drive to
eradicate polio globally. Congressional support to CDC has supported
the following essential polio eradication activities:
Leadership on surveillance and disease detection. CDC's Atlanta
laboratories serve as a global reference center and training facility,
providing expertise in virology, diagnostics, and laboratory
procedures, including quality assurance, and genomic sequencing of
samples obtained worldwide, and training virologists from around the
world in advanced poliovirus research and public health laboratory
support. CDC also provides the largest volume of operational
(poliovirus isolation) and technologically sophisticated (genetic
sequencing of polio viruses) lab support to the 145 laboratories of the
Global Polio Laboratory Network (GPLN). CDC also developed methods to
directly detect poliovirus from patient stool specimens, allowing
faster detection. Specific support was also provided to expand
environmental surveillance to detect and respond to vaccine-derived
poliovirus outbreaks in Democratic Republic of the Congo, Nigeria,
Somalia, and Kenya.
CDC provides critical technical capacity and program management
expertise which directly contributes to polio eradication activities
and is also used to build in-country capacity.
--CDC supported the international assignment of technical staff on
direct 2-year assignments to WHO and UNICEF to assist polio-
endemic and polio-reinfected priority countries. Funding was
also provided to WHO for surveillance, technical staff and
immunization activities' operational costs, primarily in
Africa.
--CDC's Stop Transmission of Polio (STOP) members continue to play a
key role in providing expertise on polio surveillance, data
management, campaign planning, implementation and evaluation,
program management, and communications in high-risk countries.
In 2020, 210 public health professionals were deployed in 42
countries with two-thirds deployed to the African Region,
contributing substantially to the region's achievement of wild
polio-free status in 2020. STOP program participants worked to
improve broader vaccine-preventable disease (VPD) surveillance.
In 2020 STOP participants also supported local governments to
promote awareness of COVID-19 and provide contract tracing.
--In Afghanistan, CDC led a comprehensive data review in 2020 that
evaluated and streamlined data collection to increase
efficiency of the evidence-based decision making in campaigns.
--In Pakistan, CDC worked with the government to transform structural
and managerial components of the polio program. CDC and NSTOP
assumed a new role to improve evidence-based decision making
through data usage and risk assessment in the core reservoir
districts/towns. CDC also provided broad support to the COVID-
19 response in Pakistan, including trainings, case
identification, investigation and tracking, and lab sample
collection.
--CDC also provided expertise in technical advisory groups, EPI
manager and other key global polio meetings.
--CDC also provided instrumental support internationally and
domestically in the areas of disease surveillance, health
worker training, contact tracing, risk communications and
testing through extensive assignment of Atlanta-based polio
staff to the CDC COVID-19 response and through support provided
to the COVID-19 pandemic response by polio staff in
Afghanistan, Pakistan, and across Africa. CDC's commitment to
polio eradication is firm and knowing that CDC's polio
eradication program operates in some of the most vulnerable
places in the world, the agency is determined to do its part in
defeating the COVID-19 pandemic.
CDC also works to build Country-level Capacity.
--In collaboration with the Pakistan Ministry of Health, WHO and
USAID's mission in Islamabad, CDC trained 88 national
epidemiologists from CDC's Field Epidemiology Training Program
(FETP) and deployed them to the highest risk districts for
circulation of wild polio virus to help improve the quality of
surveillance and immunization activities there and to
strengthen routine immunization systems.
--CDC also trained and supported 230 staff at the Local Governing
Area level in the highest risk states through CDC's National
STOP program for Nigeria, playing a key role in interrupting
transmission of wild polio. CDC also contributed to UNICEF's
expansion of a Community Based Vaccinator Program in Pakistan
that includes over 24,000 workers who reach 4 million children
annually with both oral and inactivated polio vaccine (IPV);
and $3 million for operational costs for NIDs in all polio-
endemic countries and outbreak countries. Most of these NIDs
would not take place without the assurance of CDC's support.
CDC provided key leadership in development and rollout of novel
oral poliovirus vaccine (nOPV), a new tool for polio eradication
through preclinical development, laboratory testing and support for
nOPV clinical trials. The new vaccine has low neurovirulence, is
genetically stable (low reversion rate), can be scaled to production
levels, is highly immunogenic, and was safe and well tolerated in
vaccine trials. Initial use of nOPV2 is taking place in countries that
have secured national immunization and regulatory group approvals and
have met strict criteria.
fiscal year 2022 budget request
We respectfully $176 million in FY2022 for the polio eradication
activities of CDC, the level appropriated by Congress in FY 2021. CDC's
priorities are to stop virus transmission in the remaining polio
endemic and outbreak countries. CDC will also work with governments and
partners in countries experiencing cVDVP outbreaks to resume high
quality vaccination campaigns and to boost routine immunization to
close immunity gaps. This includes reaching an estimated 80 million
children who are vulnerable due to COVID-19 pandemic related
disruptions. CDC will also work to address pandemic-related
surveillance gaps to safeguard global disease detection and response
capacity. CDC will continue planning for a post-polio transition to
advance broader global vaccine-preventable diseases (VPD) control and
elimination/eradication targets as outlined in CDC's Global
Immunization Strategic Framework 2021-2030.
the role of rotary international
Rotary is a global network of leaders who connect in their
communities and take action to solve pressing problems. Since 1985,
polio eradication has been Rotary's flagship project, with members
donating time and money to help immunize nearly 3 billion children in
122 countries. Rotary's chief roles are fundraising, advocacy
(including resource mobilization and political advocacy), raising
awareness and mobilizing volunteers. There are nearly 300,000 members
throughout the United States who have raised more than US$400 million
of the more than US$2.2 billion Rotary has contributed to the Global
Polio Eradication Initiative. This represents the largest contribution
by an international service organization to a public health initiative
ever. These funds have benefited 122 countries to buy vaccine and the
equipment needed to keep it at the right temperature, and support the
means to ensure it reaches every child. More importantly, tens of
thousands of our volunteers have been mobilized to work together with
their national ministries of health, UNICEF and WHO, and with health
providers at the grassroots level in thousands of communities.
Rotary also plays a key role in encouraging country level
accountability. Rotary has National PolioPlus Committees, in the
endemic countries and over 20 outbreak/at-risk countries. These
national committees work to keep the spotlight on polio eradication
amidst competing priority from the community level to the federal
level.
benefits of polio eradication
Since 1988, tens of thousands of public health workers have been
trained to manage massive immunization programs and investigate cases
of acute flaccid paralysis. Cold chain, transport and communications
systems for immunization have been strengthened. The global network of
146 laboratories and trained personnel established by the GPEI also
tracks measles, rubella, yellow fever, meningitis, and other deadly
infectious diseases including COVID-19 and will do so long after polio
is eradicated. $27 billion in health cost savings has resulted from
eradication efforts since 1988. A sustained polio free world will
generate $14 billion in expected cumulative cost savings by 2050, when
compared with the cost countries will incur for controlling the virus
indefinitely. Polio eradication is a cost-effective public health
investment with permanent benefits. As many as 200,000 children could
be paralyzed annually in the next decade if the world fails to
capitalize on the more than $18 billion already invested in
eradication. Success will ensure that the investment made by the US,
Rotary International, and many other countries and entities, is
protected in perpetuity.
[This statement was submitted by Anne L. Matthews, Chair, Rotary's
Polio
Eradication Advocacy Task Force.]
______
Prepared Statement of the Ryan White Medical Providers Coalition
Chairwoman Murray, Ranking Member Blunt, and members of the
Subcommittee, my name is Dr. Rachel Bender Ignacio and I serve as an
HIV primary care physician at the Madison Clinic and Director of the
AIDS Clinical Trials Unit at Harborview Medical Center in Seattle,
Washington. I am pleased to submit testimony on behalf of the Ryan
White Medical Providers Coalition (RWMPC) of the HIV Medicine
Association (HIVMA). I currently serve on the Board of Directors of
HIVMA. RWMPC is a national coalition of medical providers and
administrators who work in healthcare agencies supported by the Ryan
White HIV/AIDS Program funded by the HIV/AIDS Bureau (HAB) at the
Health Resources and Services Administration (HRSA).
First, I would like to thank the Subcommittee for increasing FY21
funding for both the Ryan White Program and the Bureau of Primary
Health Care at HRSA by funding the bipartisan Ending the HIV Epidemic
(ETE) initiative. Supporting the ETE initiative will help target
jurisdictions scale up their ability to end the HIV epidemic by
increasing access to HIV testing, prevention, care, and treatment
services critical to reducing HIV transmission. However, expanding the
Ryan White Program even further now would help jurisdictions nationwide
address ending the HIV epidemic. To achieve this expansion, I request
$225.1 million (a 10% or $24 million increase) in FY22 for Ryan White
Part C, which supports approximately 350 HIV medical clinics
nationwide.
RWMPC also requests additional resources for the ETE initiative to
expand access to HIV prevention, care, and treatment, including $364
million for HRSA's ETE program. This funding would include $212 million
for the Ryan White Program to provide additional HIV care and
treatment, as well as $152 million for the Bureau of Primary Health
Care to support HIV prevention services, including providing Pre-
Exposure Prophylaxis (PrEP), medication to prevent HIV. These funding
levels also were requested by the President's FY22 budget request.
It is especially important now that increases for Ryan White Part C
or for the ETE initiative be new, additional funding and not a
repurposing of current resources. The additional pressure that the
COVID-19 pandemic has placed on public health infrastructure and
medical facilities, including Ryan White clinics, is significant and
limited resources cannot be further stretched.
In fact, COVID-19 has demonstrated why our nation needs to
strengthen the public heath infrastructure and medical clinics serving
people living with HIV. Ryan White clinics have been critical to
providing an effective COVID-19 response and many Ryan White medical
providers have been pulled in as leaders of the pandemic response in
their jurisdictions. This has worked well as these providers are
infectious diseases experts who have significant experience caring for
vulnerable populations.
The flexibility of the Ryan White Program and the knowledge and
innovation of its medical providers also has allowed Part C clinics to
respond to the changing needs of patients and the health care system
throughout the transitions and challenges of the COVID-19 pandemic.
Part C clinics have helped people with HIV by sustaining access to
health care and medication through telehealth and key services, such as
case management and transportation; by enrolling new patients who lost
their health insurance as a result of the economic downturn; and by
providing PPE, food, and housing security during this emergency.
Madison Clinic at Harborview Medical Center in Washington Has Expanded
Access to HIV Prevention, Care, & Treatment
Since 1986, the Madison Clinic has served as the leading source of
HIV primary care in the Pacific Northwest when its HIV care program was
expanded with the assistance of Ryan White Program funding. Since then,
the clinic has grown dramatically and now serves 2,800 individuals
living with HIV, most with complex medical and psychosocial needs.
Approximately 30% of our population is Black or African American
(Seattle overall has 7% Black representation), 15% is Latinx, and 10%
is Asian, Pacific Islander, or Native American. 47% of patients live at
or below the federal poverty level. Like other HIV clinics across the
US, ours serves an increasingly aging population, with 60% of patients
over the age of 45. As a result, the burden of co-morbid illnesses,
such as cancer, cardiovascular disease, and metabolic complications
such as diabetes is extremely high. Alarmingly, 12% of patients lack
permanent housing, and many patients were negatively impacted by the
intersection of housing instability; the opioid epidemic and HIV
epidemics; and the COVID-19 pandemic. Madison Clinic, like most Ryan
White Part C clinics, also receives support from other parts of the
Ryan White Program that help us provide medications, additional medical
care, and support services, such as case management and transportation,
all key to the comprehensive Ryan White care model that produces
outstanding outcomes.
Madison Clinic also provides Pre-Exposure Prophylaxis (PrEP)
services across the clinic. This critical HIV prevention tool is
integrated at Madison Clinic as part of prevention and primary care
services. However, more support for the PrEP program, including for
PrEP navigators and lab tests, is needed to scale up these services to
meet patient needs.
Many Harborview patients struggle with HIV, substance use disorder
(SUD), and related infectious diseases, such as hepatitis C. In
response, in partnership with the Public Health Department for Seattle-
King County, the Max Clinic was established to care for people living
with HIV who have not yet achieved viral suppression and who experience
multiple barriers to care. The Max Clinic serves approximately 200
patients, and receives support from Part B of the Ryan White Program as
well as funding from the local Health Department.
Ryan White Part C Clinics are Effective Medical Homes and Public Health
Programs
Ryan White Part C directly funds approximately 350 community health
centers and clinics that provide comprehensive HIV medical care
nationwide, serving more than 300,000 patients each year. These clinics
are the primary method for delivering HIV care to rural jurisdictions--
approximately half of all Part C providers serve rural communities. The
program's comprehensive services engage and keep people in HIV care and
treatment. This is critical, because HIV disease is infectious, so
identifying, engaging, and retaining individuals living with HIV in
effective care and treatment saves lives and benefits public health by
stopping HIV transmission when individuals are virally suppressed.
In 2019, more than 88% of Ryan White patients were virally
suppressed--an almost 27% increase in the program-wide viral
suppression rate since 2010. In 2020, 94% of Madison Clinic patients
have been virally suppressed in spite of the complex challenges the
COVID-19 pandemic has presented. The Ryan White Part C program's
comprehensive services engage and keep people in HIV care and
treatment. For example, 98% of HIV patients are on antiretroviral
therapy at Madison Clinic. Early, reliable access to HIV care and
treatment helps patients with HIV live healthy and productive lives and
is more cost effective.
Part C Clinics Are on the Frontlines of the Opioid Epidemic and Provide
SUD Treatment
Ryan White clinics serve a significant number of individuals living
with both substance use disorder (SUD) and HIV. The majority of Madison
Clinic providers have the credentials to prescribe buprenorphine
therapy (medication assisted treatment for Substance Use Disorder), and
our providers treat viral hepatitis, supported by a multidisciplinary
team in our clinic. Part C clinics are able to deliver a range of
medical and support services, including overdose prevention and harm
reduction services, needed to prevent, intervene, and treat substance
use disorder as well as related infectious diseases, including HIV,
hepatitis C, and sexually-transmitted infections. The experience and
expertise of Ryan White Part C medical providers should be leveraged to
effectively respond to the opioid epidemic and overdose crisis and to
help rapidly expand access to urgently needed SUD services.
Funding for Prevention and Harm Reduction at CDC and Research at NIH is
Critical
While my testimony has focused on HRSA programs, the ability to
effectively respond to the syndemics of HIV, substance use disorder,
and related infectious diseases such as hepatitis C; sexually
transmitted infections; and skin, soft tissue, and endovascular
infections depends on CDC funding to enhance surveillance and
prevention activities, and on NIH to continue to improve the tools to
prevent and treat HIV and SUD and to learn how to effectively implement
them. The AIDS Clinical Trials Unit, a member of the AIDS Clinical
Trials Group funded by the NIH, is co-located within Madison Clinic and
provides direct access for our patients to participate in research that
pushes the envelope on HIV and viral hepatitis treatment, including a
focus on HIV remission/cure strategies.
We request $371 million for CDC to provide surveillance, response,
and other HIV prevention services as part of the ETE initiative, as
well as $120 million for CDC to address the infectious diseases
consequences of the opioid epidemic, including by supporting and
expanding access to syringe services programs, harm reduction, and
overdose prevention. Finally, we support continued robust funding for
NIH, including for HIV research. This funding supports discoveries that
will help to end the HIV, hepatitis C, and opioid epidemics and that
have informed the treatment and prevention of COVID-19.
Thank you for your time and consideration of these requests, and
please don't hesitate to contact me or Jenny Collier, Convener of the
Ryan White Medical Providers Coalition, at
[email protected] if you have any questions or need
additional information.
[This statement was submitted by Rachel Bender Ignacio, MD, MPH,
HIV
Physician and Clinical Researcher at the Madison HIV Clinic.]
______
Prepared Statement of Safer Foundation
Thank you, Chairwoman Murray, Ranking Member Blunt, and members of
the Subcommittee, for inviting me to submit testimony on behalf of the
Safer Foundation. My name is Kevin Brown and I serve as the Director of
Policy, Advocacy, and Legislative Affairs for the Safer Foundation. For
almost 50 years, Safer has provided comprehensive workforce development
and reentry services for individuals with criminal legal histories
seeking employment. There is dignity in work, and Safer Foundation
believes that individuals who have made mistakes should have the
opportunity to be self-sufficient and contribute to their families and
communities through gainful, living wage employment. Clients come to
Safer Foundation because they want and need to work, and Safer helps
clients discover career path employment that is personally fulfilling
and that pays a living wage.
A critical federal program that supports these efforts is the
Reentry Employment Opportunities (REO) program (also known as the
Reintegration of Ex-Offenders (RExO) program) within the Department of
Labor's Employment & Training Administration. I thank the Subcommittee
for providing REO with $100 million in FY21. Given the need to train
people for the jobs our economy requires in industries such as health
care, technology, and logistics; to help employers identify the
qualified workers they need now; and to help people with criminal legal
histories find living wage employment to support successful, long-term
reentry, I urge the Subcommittee to provide $150 million for the REO
program in FY22.
employment reduces recidivism and improve reentry outcomes
1 in 3 adults in the United States has a criminal record that
interferes with their ability to find a job.\1\ The COVID-19 pandemic
has underscored existing barriers to employment for people with
criminal legal histories. Research shows that sustained, living wage
employment and life skills are critical components to long-term reentry
success. One study found that individuals who were employed and earning
higher wages after release were less likely to return to prison within
the first year.\2\ The REO program improves reentry success by working
with individuals to overcome employment barriers with training for jobs
in local high-demand industries through career pathways and industry-
recognized credentials and by providing needed reentry supports.
Increasing REO funding would expand access to these comprehensive
workforce development and reentry services that are especially needed
now.
---------------------------------------------------------------------------
\1\ ``Research Supports Fair-Chance Policies'' (March 2016),
National Employment Law Project, footnote 1 on p. 7. Available at
http://www.nelp.org/publication/researchsupports-fair-chance-policies.
\2\ Visher, C., Debus, S., & Yahner, J. Employment After Prison: A
Longitudinal Study of Releasees in Three States. Washington, DC: Urban
Institute (2008).
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Authorized by section 169 of Workforce Innovation and Opportunity
Act (WIOA), the REO program provides workforce preparation and reentry
services for both adults and young people. REO includes a set-aside to
provide services to prepare youth who are justice-system involved and/
or who have not completed school or other educational programs for
employment. Research has found that incarceration reduces a formerly
incarcerated person's earning potential by more than 52 percent,\3\
making workforce development services essential for long-term
employment and reentry success. In light of the costs of the criminal
legal system at the state, local, and federal levels, the REO program
is crucial to incubating community-based models of successful reentry
through employment.
---------------------------------------------------------------------------
\3\ Craigie Terry-Ann; Grawert, Ames; Kimble, Cameron, Stiglitz,
Joseph (2020); Conviction, Imprisonment, and Lost Earnings: How
Involvement with the Criminal Justice System Deepens Inequality:
https://www.brennancenter.org/our-work/research-reports/conviction-
imprisonment-and-lost-earnings-how-involvement-criminal.
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COVID-19 has impacted employment opportunities for people with
criminal legal histories. During the last economic downturn in 2008,
the unemployment rate for people with criminal legal histories was
27%--2 points higher than the unemployment rate during the Great
Depression. Increasing support for the REO program is an effective way
to ensure that individuals with criminal legal histories, who are
disproportionately Black people and people of color, are not left out
of the nation's economic recovery.
safer's reo-supported services increase employment by working with both
employers and employees
Safer Foundation offers comprehensive workforce development and
reentry services that train individuals, address their reentry
obstacles and needs, and help them obtain sustained employment. This
holistic approach has rendered outstanding results for participants and
employers. In 2006, decades of experience and success led Safer to
become one of the original REO grantees.
In addition to working with reentering individuals and their
communities, Safer also works closely with employers to identify what
types of trained employees are needed. In November 2020, the National
Federation of Independent Business (NFIB) reported that 53% of
businesses overall (and 89% of those hiring or trying to hire) reported
few or no qualified applicants for available positions. While the
demand for qualified workers exists, many newly unemployed individuals
may not meet the qualifications for particular industries. Safer can be
responsive to employer needs by tailoring its programs to develop
skilled, qualified workers for specific employment sectors and has
partnered with hundreds of employers to do so.
Safer's Training to Work (T2W) program, that was funded in part
with a REO grant, improved long-term employment prospects for clients
at Safer's Adult Transition Centers (ATC). Participants received case
management, education, and training that led to industry-recognized
credentials for in-demand employment, such as forklift operation,
welding, computer numerical control (CNC) operation, and licensed
commercial driving (CDL) occupations, and Microsoft technologies
training. Given the program's strong employer and credentialing
components, REO is uniquely positioned to assist local organizations in
developing and providing services that meet the needs of both the local
business community and reentering individuals. Increasing REO funding
in FY22 to $150 million, including funding for earn and learn
apprenticeship opportunities for in demand skills development, would
expand these efforts and help provide employers with more qualified
employees who are trained, talented, motivated to work.
safer's reo grant produced outstanding employment outcomes and reduced
recidivism
Safer's REO grant for the Training to Work (T2W) program
significantly outperformed employment targets and dramatically reduced
recidivism. For the first cohort of REO T2W participants, 69% of
participants obtained employment--15% higher than the grant's
employment target. Given the success of this first cohort of
participants, T2W was expanded to include a second cohort who did even
better with an employment rate of 78%--30% higher than the grant's
target. Safer's REO T2W grant also reduced recidivism rates beyond
original targets. T2W's first participant cohort had an 11% recidivism
rate, and its second participant cohort had a 9% recidivism rate--75%
and 80% lower respectively than the national recidivism rate of 44%.\4\
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\4\ Durose, Matthew R., Alexia D. Cooper, and Howard N. Snyder,
Recidivism of Prisoners Released in 30 States in 2005: Patterns from
2005 to 2010 (pdf, 31 pages), Bureau of Justice Statistics Special
Report, April 2014, NCJ 244205.
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Program evaluation has shown that such success is related to the
comprehensive service model that grantees such as Safer provide.
Effective, comprehensive services can include interventions such as
relationship building between staff and participants, employment
verification, trauma-informed training, life skills training,
employment preparation, mentoring, intensive case management, strong
training provider relationships and support, family involvement, and
post-release follow-up and support. These comprehensive services are
cost-effective--a 2016 Illinois study found that for every $1 invested
in community-based employment and training programs, tax payers saw a
net benefit of $20.26, and found that employment and training programs
had the highest cost-benefit ratio for reducing recidivism.\5\ By
increasing and improving employment outcomes, the REO program invests
in formerly incarcerated people and their families, provides for a more
equitable recovery, and improves public safety.
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\5\ Illinois Sentencing Policy Advisory Council (2016). A Cost-
Benefit Tool for Illinois Criminal Justice Policymakers, pp. 2-3:
http://www.icjia.state.il.us/spac/pdf/Illinois_Results_First_
Consumer_Reports_072016.pdf, pp. 2-3.
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investments in reentry programs are consistent with the fy22
president's budget request
Reentry and workforce development are a priority for the current
administration, and the FY22 President's Budget requests includes $150
million for the REO program to provide support for ``reentry services,
and recidivism-reducing programming...'' The budget request also calls
for increases in skills-building that ``advances the goal of developing
pathways for diverse workers to access training and career
opportunities by also investing in critical programs that serve
disadvantaged groups, including justice-involved individuals, [and] at-
risk youth.''
The REO funding request also is consistent with the
administration's goal of pursuing racial equity. Black people and other
people of color are disproportionately impacted by the criminal legal
system. Black people are incarcerated at more than 5 times the rate of
white people. In 2018, the incarceration rate of Black men was 5.8
times higher than that of white men, and Black young men ages 18-19
years old were 12.7 times as likely to be incarcerated as white young
men in the same age group. In 2018, Black women were almost twice as
likely to be incarcerated as white women, and Black girls were 3 times
more likely to be incarcerated than white girls.
Upon release, these disparities persist as a result of systemic and
institutional racism and discrimination; collateral consequences of
conviction that ban or limit legal access to employment, licensure, and
education supports; and a limited investment in resources for the large
number of people returning each year who come back to their communities
without the basic support and tools needed for long-term success.
Providing federal resources for workforce development and reentry helps
to ensure greater success and helps to address unfair barriers that
exist as a result of systemic racism and inequities that disadvantage
individuals directly impacted by the criminal legal system.
Finally, the REO program is critical for economic recovery for
people with criminal legal histories, especially Black people and
people of color, who also have been disproportionately impacted by
COVID-19. There has been very limited COVID-19 relief for incarcerated
people and people with criminal legal histories, and REO is the only
federally appropriated program that focuses on workforce development
and employment for people with records (1 out of 3 adults in the U.S.
has an arrest or conviction record). As the economy recovers and
workforce needs continue to evolve and change, it is essential to
ensure that this significant population has the reentry and workforce
supports to facilitate gainful employment and long-term reentry
success.
conclusion
By making effective workforce development and reentry services a
priority, we fulfill labor market demands, contribute to the economy,
and build strong and safe communities. Given the extensive employment
and reentry needs nationwide, as well as the significant return on
investment related to reduced incarceration costs and reduced crime
costs borne by victims, families, and communities, I urge Congress to
allocate $150 million to the REO program in FY22.
Thank you so much for your time and consideration of this important
program. If you have questions or need additional information, please
don't hesitate to contact me or Jenny Collier at
[email protected].
[This statement was submitted by Kevin Brown, Director of Policy,
Advocacy, and Legislative Affairs.]
______
Prepared Statement of the Scleroderma Foundation
the foundation's fiscal year 2022 l-hhs appropriations recommendations
_______________________________________________________________________
--$10 billion in program level funding for the Centers for Disease
Control and Prevention (CDC), which includes budget authority,
the Prevention and Public Health Fund, Public Health and Social
Services Emergency Fund, and PHS Evaluation transfers.
--A proportional funding increase for CDC's National Center for
Chronic Disease Prevention and Health Promotion (NCCDPHP).
--$5 million for the Chronic Disease Education and Awareness
Program which seeks to improve public health and lower
healthcare costs through targeted awareness, physician
education, and public health campaigns conducted in
collaboration with stakeholder organizations and
communities.
--At least $46.1 billion in program funding for the National
Institutes of Health (NIH).
--Proportional funding increases for NIH's National Heart, Lung,
and Blood Institute (NHLBI); National Institute of
Arthritis and Musculoskeletal and Skin Diseases (NIAMS);
National Center for Advancing Translational Sciences
(NCATS).
_______________________________________________________________________
Chairwoman Murray, Ranking Member Blunt and distinguished members
of the Subcommittee, thank you for your time and your consideration of
the scleroderma community's priorities while working to craft the
FY2022 L-HHS Appropriations Bill.
about scleroderma
Scleroderma is a chronic connective tissue disease affecting
approximately 300,000 Americans. The word scleroderma means hardening
of the skin, which is one of the most visible manifestations of the
condition. The cause of this progressive and potentially fatal disease
remains unknown. There is no cure, and treatment options are limited.
Symptoms vary greatly and are dependent on which organ systems are
impacted. Prompt diagnosis and treatment by a qualified physician may
improve health outcomes and lessen the chance for irreversible damage.
Serious complications of the disease can include pain, skin ulcers,
anemia and pulmonary hypertension.
about the foundation
The Scleroderma Foundation is dedicated to the concerns of people
whose lives have been impacted by the autoimmune disease scleroderma,
also known as systemic sclerosis, and related conditions. The
foundation's mission is to 1) support individuals affected, 2) promote
education and public awareness, and 3) advance critical research and
improve scientific understanding to improve treatment options and find
the causes and a cure. The foundation has a research program that funds
basic, translational and clinical research through a peer review
process to find the cause and cure for scleroderma and related
conditions.
centers for disease control and prevention
Early recognition and an accurate diagnosis of scleroderma can
improve health outcomes and save lives. CDC in general and the NCCDPHP
specifically have programs to improve public awareness of scleroderma
and other rare, life-threatening conditions. Please increase funding
for CDC and NCCDPHP so that the agency can invest in additional,
critical education and awareness activities that have the potential to
improve health and save lives. The Foundation supports the continued
support of the Chronic Disease Education and Awareness Program, this
program seeks to provide collaborative opportunities for chronic
disease communities that lack dedicated funding from ongoing CDC
activities. Such a mechanism allows public health experts at the CDC to
review project proposals on an annual basis and direct resources to
high impact efforts in a flexible fashion.
national institutes of health
NIH continues to work with the Foundation to lead the effort to
enhance our scientific understanding of the mechanisms of scleroderma
with the shared-goal of improving diagnosis and treatment, and
ultimately finding a cure. Since scleroderma is a systemic fibrotic
disease it is inexorably linked to other manifestations of fibrosis
such as cirrhosis, pulmonary fibrosis, and the fibrotic damage
resulting from heart attack. Scleroderma is a prototypical
manifestation of fibrosis as it impacts multiple organ systems. In this
way, it is important to promote cross-cutting research across such
Institutes as NIAMS and NHLBI.
Please provide NIH with a significant funding increase to the
scleroderma research portfolio can continue to expand and facilitate
key breakthroughs.
--NIH continues to support the Trans-NIH Working Group on Fibrosis
which is working to promote cross-cutting research across
Institutes.
--NHLBI, which is leading Scleroderma Lung Study II, is comparing the
effectiveness of two drugs in treating pulmonary fibrosis in
scleroderma.
--NIAMS, is leading efforts to discover whether three gene expression
signatures in skin can serve as accurate biomarkers predicting
scleroderma, and investigations into progression and response
to treatment to clarify the complex interactions of T cells and
interleukin-31 (IL-31) in producing inflammation and fibrosis,
or scarring in scleroderma.
patient perspective
``My constantly aching hands begged for mercy of just one day
without pain. My joints started to feel like they were being torn away
from my body. Anytime I touched something cold, my hands would tingle
and burn. Painful sores started appearing on my knuckles. You stole my
skin color and with that went my confidence. It was like I was turning
into a mummy as my skin tightened with collagen, day by day. I was
beginning to need help performing small tasks. Opening a water bottle
or turning a key in the door started to become difficult. Standing for
long periods of time made my hips radiate with pain. In 2012 I had to
stop working, at 24 years old. The definition of normal as I knew it
was being torn down and built into something completely new. And so was
my soul.
I now need help with everything! Getting dressed, washing my hair,
cleaning, doing laundry; pretty much anything I have to use my hands
for. You stole my independence. I had to learn to swallow my pride and
ask for help. It's a tough thing to do, especially when you're at an
age that's supposed to be your prime. Friends and family around me have
blossomed into caregivers and helping me has become second nature to
them. It's a beautiful thing when those surrounding you automatically
adapt to your disability. Support is the lifeboat that keeps me
afloat.''
--Excerpt from ``My Letter to Scleroderma''
Jessica Messingale
Coconut Creek, Florida
[This statement was submitted by Mr. David Murad, Director of
Advocacy, Scleroderma Foundation.]
______
Prepared Statement of the Seattle Indian Health Board
Chair Murray, Ranking Member Blunt, and members of the Senate
Committee on Appropriations--Subcommittee on Labor, Health, and Human
Services, Education, and Related Agencies, my name is Esther Lucero. I
am Dine, and of Latina descent and as the third generation in my family
to live outside of our reservation, I strongly identify as an urban
Indian. I serve as the President & CEO of the Seattle Indian Health
Board (SIHB), one of 41 Urban Indian Health Programs (UIHP) nationwide.
I have had the privilege of serving SIHB for five years. I am honored
to have the opportunity to submit my testimony today, including a
request for the following 1) Address Department of Health and Human
Services (HHS) grant eligibility and grant restrictions 2) Develop an
HHS urban confer policy; 3) Ensure HHS public health data access to
Tribal Epidemiology Centers (TEC) 4) Create National Institutes of
Health (NIH) research funding opportunities specific to urban Indian
populations; 5) Invest in Indian healthcare and public health
infrastructure, including culturally attuned integrated workforce
development.
indigenous resilience in action
I would like to thank the Subcommittee for COVID-19 supplemental
funding which has included at least $18 million for UIHPs from the
Centers of Disease Control and Prevention (CDC); $9.5 billion for
Federally Qualified Health Centers (FQHC) from the Health Resources and
Services Administration (HRSA), and; at least $140 million to Indian
Health Care Providers through the Substance Abuse and Mental Health
Services Administration (SAMHSA). Supplemental funding has demonstrated
how successful and resilient our Indian healthcare system can be when
properly resourced. I would also like to acknowledge the President's
Budget for FY 22 which includes $131.7 billion for HHS, including $12.6
billion for HRSA, and $9.7 billion for SAMHSA. We hope President
Biden's proposed increases will support significant investments to
FQHCs, tribal and urban Indian populations, and reducing chronic health
disparities in Black, Indigenous, and Communities of Color (BIPOC).
As one of 41 Indian Health Service (IHS) designated UIHPs and a
HRSA 330 FQHC, SIHB serves over 5,000 patients annually of which 70%
identify as American Indian and Alaska Native. UIHPs are a critical
component of the Indian healthcare system and offer culturally attuned
health services to the 2.2 million American Indians and Alaska Natives
who live in 115 counties across 24 states. We also house the Urban
Indian Health Institute (UIHI), an IHS designated TEC and public health
authority, which conducts research and evaluation, collects and
analyzes data, and provides disease surveillance for 62 urban Indian
communities nationwide.
As an Indian Health Care Provider, we are actively limiting the
spread of COVID-19 in tribal and urban Indian communities. In December
2020, SIHB was the first organization in Seattle to receive a shipment
of the Moderna vaccine and since has vaccinated over 12,500
individuals. Locally, we serve as a COVID-19 testing site at our main
clinical facility and operate a community-based walk-up testing site at
our satellite clinic serving American Indian and Alaska Native people
experiencing homelessness in Seattle, Washington. With the support of
federal supplemental funding, we continue to secure pharmacy supplies
and equipment to respond to the immediate and forthcoming COVID-19
needs in the greater Puget Sound region, including testing kits,
panels, and a diagnostic testing machine to improve testing capacity
and response times. We have implemented a telehealth program, expanded
outpatient behavioral health services, provided rental assistance, and
developed a pediatrics clinic to increase child immunization rates.
Throughout the pandemic, UIHI has disseminated culturally attuned
COVID-19 information through fact sheets, reports, and a COVID-19
Vaccine Poster series to address vaccine hesitancy in the Native
community. Recently, UIHI launched For the Love of Our People, a
webpage dedicated to bringing Native health experts and creatives to
provide engaging, up-to-date information about COVID-19 vaccines and
COVID-19 related topics. UIHI has also led local to national public
health surveillance for UIHPs through weekly reporting and analysis of
local to state COVID-19 case surveillance data.
continued gaps for urban indian organizations
Address Department of Health and Human Services (HHS) grant
eligibility and grant restrictions: UIOs offer culturally responsive
services for the 71% of American Indians and Alaska Natives in urban
areas. Given that the average IHS grant to an UIHP is $280,000, most
UIHPs must seek additional resources from HHS agencies to ensure robust
access to health and social services that allow our communities to
thrive. Yet, many HHS agencies exclude UIHPs from grant eligibility or
apply restrictive grant terms that hinder our ability to provide
culturally specific and low-barrier services. To ensure HHS resources
for American Indian and Alaska Native people fulfill trust and treaty
obligations, we ask Congress to:
Ensure Urban Indian Organizations are included in grant
eligibility: If the intent of Congressional funds is to reach all
American Indian and Alaska Native people, then legislative and
administrative language must include 'tribes, tribal organizations, and
Urban Indian Health Programs as defined in Section 4 of the Indian
Health Care Improvement Act (authorized under 25 U.S.C. Ch. 18.
Subchapter IV Sec. 1653). This ensures federal resources reach American
Indian and Alaska Native people, regardless of where they reside.
Address barriers created by GPRA tools: Current requirements of the
Government Performance and Results Act (GRPA) performance data
is burdensome to patients and providers. To operate a truly
culturally attuned and low-barrier Medication Assisted
Treatment (MAT) programs, we must address the longstanding
issues with cumbersome and onerous GPRA reporting requirements.
For example, SIHB provides an unduplicated service of low-
barrier MAT services for urban American Indians and Alaska
Natives who are disproportionately affected by substance use in
Washington State. Our American Indian and Alaska Native
patients come to SIHB for our integrated patient-centered care
model that promotes the wellness of our patients and is
centered on Traditional Indian Medicine. Lengthy and invasive
GPRA survey tools directly affect our service delivery system
to provide accessible low-barrier and culturally attuned MAT
services. We ask that Congress address barriers created by GRPA
tools to better support culturally attuned and low barrier
services provided by Indian Health Care Providers.
Develop an HHS urban confer policy: To ensure trust and treaty
obligations are upheld to all American Indian and Alaska Native
citizens, we request the development of an Urban Confer policy across
all agencies and departments within HHS jurisdiction. The federal
government has an obligation to consult with Tribal Nations on issues
that impact tribal communities. In the Indian healthcare system, UIHPs
have an Urban Confer mechanism with the IHS that provides an
opportunity for an exchange of information and opinions that lead to
mutual understanding and emphasize trust, respect, and shared
responsibility between UIHPs and government agencies. Urban Confer
policies do not substitute for nor invoke the rights of a Tribe as a
sovereign nation. An Urban Confer supports the advocacy for the urban
Indian community by Indian Health Care Providers who are part of the
Indian healthcare system.
The importance of an Urban Confer was made evident in the COVID-19
supplemental resources from Congress. Without an Urban Confer policy,
HHS agencies outside of IHS had no formal mechanism for gathering
feedback from UIOs and vice versa. As a result, submitting feedback to
HRSA, SAMHSA, and the CDC was a significant barrier to accessing COVID-
19 supplemental resources for UIOs. For example, the CDC created a
funding opportunity for 11 of the 12 TECs by selecting a grant
mechanism that failed to include UIOs as eligible entities. This
barrier leaves UIOs without access to federal resources, despite
Congressional intent.
Ensure HHS public health data access to Tribal Epidemiology Centers
(TEC): Despite Congressional authorization to access HHS data as a
public health authority, CDC continues to deny UIHI and other TECs
access to data collected through the National Notifiable Disease
Surveillance System (NNDSS). Timely analysis of NNDSS data and other
CDC collected COVID-19 data is critical to supporting both tribes and
UIOs to prevent, prepare, and respond to system health inequities
experienced by American Indian and Alaska Native communities. A failure
to uphold data access perpetuates systemic health inequities in
American Indian and Alaska Native communities. With the limited COVID-
19 case surveillance data provided, TECs have been able to monitor,
evaluate, and respond to COVID-19 through contact tracing, primary
collection and secondary analysis of epidemiological data, and
development of culturally attuned public health resources. The COVID-19
resources developed by TECs range from public health guidance to
treatment and vaccine information that have been disseminated to
tribes, tribal organizations, UIOs, and government agencies. We ask
Congress to ensure compliance with data sharing requirements by all HHS
agencies with TECs.
Create NIH research funding opportunities specific to urban Indian
populations: Current NIH initiatives often are not inclusive of urban
Indian populations, despite 71% of all American Indian and Alaska
Native people living in urban settings and a growing body of
documentation of health disparities among urban Native populations. In
addition, the COVID-19 pandemic has highlighted the lack of diversity
in clinical trials which perpetuates bias in research studies. In
Indian Country, the lack of an American Indian and Alaska Native
population samples in clinical trials contributed to vaccine hesitancy
and has been used by anti-vaccination advocates to push misinformation
into Native communities. We do not advocate for taking away funding for
tribally based research. Instead, we urge Congress to ensure NIH create
dedicated funding for research and clinical trials that are inclusive
of urban Indian populations.
Invest in Indian healthcare infrastructure:
Public health infrastructure: The COVID-19 pandemic has exacerbated
the crumbling infrastructure of our public health systems,
specifically data systems. Many of the data quality issues
identified by UIHI in the Data Genocide report are linked to
outdated public health data infrastructure systems that limit
the ability to appropriately collect and report data for
national public health surveillance and epidemiology. There is
an urgent need to invest significant resources in data
modernization, specifically across our Indian healthcare
system--including tribal health programs, UIHPs, and TECs. Data
modernization increases inter-operability of data systems and
advances data standards so information can be stored and shared
across systems, and facilitate complete reporting of data
critical for achieving equity in public health responses. We
recommend an increased investment dedicated to infrastructure
improvement and construction specifically for UIHPs that does
not divert any resources from tribal communities that are also
in desperate needs of public health infrastructure investments.
UIHP healthcare facilities: There is no national level data on the
infrastructure needs of UIHPs, yet we know from experience our
facilities are inefficient and overcrowded, which compromises
the provision of critical health services and contribute to
health disparities among urban Indian communities. UIHPs are
ineligible for the Health Care Facilities Construction line
item in the IHS budget. Recent COVID-19 supplements have
allowed for some flexible spending to address the overwhelming
infrastructure needs of UIHPs, yet lack we still lack the
resources needed to develop integrated care settings that are
patient-centric and culturally attuned. We ask that Congress
identify resources for UIHPs for the construction, expansion,
alteration, and renovation of healthcare facilities.
Culturally attuned integrated workforce development: Our healthcare
systems are in need of additional investments to fulfill
integration of behavioral health and medical care. A 2018 GAO
report on IHS found a 25% vacancy rate for nurses, physicians,
and other care providers. It is a critical time to make
targeted investments in building up a culturally attuned
workforce across the Indian healthcare system that is prepared
to provide integrate care that address pervasive health
disparities among American Indian and Alaska Native
populations. We ask Congress to invest in recruitment and
retention of health professionals to address chronic health
care provider shortages in Indian Country.
Thank you for your support and consideration of the requests. We
look forward to our continued work to improve the health and well-being
of American Indian and Alaska Native people.
Sincerely.
[This statement was submitted by Esther Lucero (Dine), MPP,
President & CEO, Seattle Indian Health Board.]
______
Prepared Statement of the Sleep Research Society and Project Sleep
fiscal year 2022 appropriations recommendations
_______________________________________________________________________
--The sleep community joins the broader research community in
requesting $46.1 billion in discretionary funding for the
National Institutes of Health (NIH), an increase of $3.2
billion over FY 2021. Sleep impacts nearly every system of the
body and various disease processes, please provide proportional
funding increases for all NIH Institutes and Centers to further
support sleep, circadian, and sleep disorders research
activities.
--Please support adequate funding to establish the new Advanced
Research Projects Agency for Health (ARPA-H) at NIH as
proposed in the Administration's Budget Request to Congress
to facilitate robust and tangible scientific progress on a
variety of conditions.
--The sleep community joins the broader public health community in
requesting $10 billion in overall funding for the Centers for
Disease Control and Prevention (CDC) to reinvigorate meaningful
professional education, public awareness, and surveillance
activities.
--Please provide the new CDC Chronic Disease Education and
Awareness Program with $5 million, an increase of $3.5
million over FY 2021, to facilitate additional cooperative
agreements to advance timely public health efforts with
community stakeholders.
_______________________________________________________________________
Chairwoman Murray, Ranking Member Blunt, and distinguished members
of the Subcommittee, thank you for considering the views of the sleep,
circadian, and sleep disorders advocacy community as you work on FY
2022 appropriations for medical research and public health programs. We
would like to take this opportunity to thank you for providing ongoing
investment in the National Institutes of Health (NIH) and the Centers
for Disease Control and Prevention (CDC) through FY 2021
appropriations, particularly for establishing and funding the new CDC
Chronic Disease Education & Awareness Program. Please bolster the
commitments to NIH and, in particular, CDC as you and your colleagues
work on appropriations for FY 2022.
about the sleep research society
The Sleep Research Society (SRS) was established in 1961 by a group
of scientists who shared a common goal to foster scientific
investigations on all aspects of sleep, circadian rhythmicity, and
sleep disorders. Since that time, SRS has grown into a professional
society comprising over 1,300 researchers nationwide. From promising
trainees to accomplished senior level investigators, sleep and
circadian research has expanded into areas such as pulmonology,
psychology, neurology, pharmacology, cardiology, immunology,
metabolism, genomics, learning and memory, and healthy living. SRS
recognizes the importance of educating the public about the connection
between sleep, circadian rhythmicity, and health outcomes. SRS promotes
training and education in sleep and circadian research, public
awareness, and evidence-based policy, in addition to hosting forums for
the exchange of scientific knowledge pertaining to sleep and circadian
rhythms.
about project sleep
Project Sleep is a 501(c)(3) non-profit organization raising
awareness about sleep health and sleep disorders by working with
affected individuals and families across the country. Believing in the
value of sleep, Project Sleep aims to improve public health by
educating individuals and policymakers about the importance of sleep
health and sleep disorders. Project Sleep will educate and empower
individuals using events, campaigns, and programs to bring people
together and talk about sleep as a pillar of health.
nih sleep research activities
Over recent years, NIH has seen a meaningful infusion of critical
funding. This investment has improved grant funding pay lines, led to
significant scientific advancements, and helped to prepare the next
generation of young investigators. For FY 2014, the sleep research
portfolio at NIH was $233 million annually. For FY 2020, the sleep
research portfolio at NIH had grown to $436 million annually, which has
been transformative for the field. However, there are still meaningful
opportunities for further scientific progress and improved patient
care.
Underserved Sleep Disorders State of the Science Conference
While research in sleep and circadian has moved forward in
significant ways (including the 2017 Nobel Prize in Medicine), research
into specific sleep disorders at NIH remains relatively modest.
Narcolepsy, hypersomnia, Kleine Levin syndrome and many other sleep
disorders have only a few active grants at any given time. To ensure
scientific progress in sleep is translated to innovative therapies,
improved diagnostic tools, and meaningful health information, the time
is now for a State-of-the-Science conference on sleep disorders. This
collaborative opportunity will help create a long-range research plan
across NIH that features specific activities for various sleep
disorders. Committee recommendations and related interest in this
regard would be timely.
Sleep Health & Health Disparities
Racial-ethnic minorities are more likely to get insufficient sleep,
and are more likely to have sleep disorders. Since sleep plays
important roles in cardiovascular function, metabolism, immunity,
mental health, and brain function, this sleep disparity creates a
situation where racial/ethnic minorities are systematically set up for
worse health outcomes. Not only does poor sleep lead to worse outcomes
on its own, it interacts with other conditions, worsening the already-
important problems associated with heart disease, diabetes, obesity,
cancer, depression, and other medical conditions. The causes of these
sleep disparities are complex and involve a combination of
socioeconomic, environmental, and other factors. Unfortunately, there
is almost no research on targeting sleep disorders diagnosis and
treatments for racial/ethnic minorities, and securing funding for sleep
disparities research is extremely difficult. As NIH works to address
health disparities, promote health equity, and enhance workforce
diversity, sleep and sleep research should be incorporated into
emerging activities.
National Heart, Lung, and Blood Institute/National Center on Sleep
Disorders Research
NCSDR has a new Director, Dr. Marishka Brown, who is taking the
field of sleep research in new and exciting directions while
reinvigorating the enthusiasm for sleep research across the federal
government. Under Dr. Brown's leadership, NCSDR is preparing to release
a strategic plan for research. We ask Congress to provide Dr. Brown
with the support she needs, including adequate resources for NHLBI and
NCSDR to coordinate ongoing and emerging initiatives.
CDC Chronic Disease Education & Awareness Program
Thank you for establishing the CDC Chronic Disease Education &
Awareness program and providing an initial investment of $1.5 million
for FY 2021. CDC currently lacks meaningful public health activities
focused on sleep and the community plans to engage this new funding
mechanism. For FY 2022, please provide $5 million in annual support.
Stacy's Story
Stacy Edwards, of Langley, Washington, first started seeing doctors
for fatigue at the age of 15. As she got older, her health declined
significantly and she couldn't figure out why. Stacy could sleep 15-18
hours and still felt tired. Doctors were sympathetic, but usually
tested for anemia and mono and sent her on her way with no solutions.
At age 31, Stacy was finally referred for a sleep study. The results
showed that she woke up 29 times per hour due to breathing
obstructions, making her diagnosis of sleep apnea on the high side of
moderate (almost severe).
Once diagnosed, Stacy started using a CPAP machine and now raises
awareness and reduces stigma via her website and social media campaign
called CPAP Babes. More recently, at age 34, Stacy was diagnosed with a
second sleep disorder, idiopathic hypersomnia. She continues to look
for better treatment options to reduce her daytime sleepiness, brain
fog, and other associated symptoms. Stacy is passionate about sleep
research and awareness because she believes that she lost many years of
her life in bed and doesn't want others to suffer for years without
answers the way she did. Educating the public and the medical community
is a high priority for Stacy.
[This statement was submitted by H. Craig Heller, PhD, President,
Sleep
Research Society and Project Sleep.]
______
Prepared Statement of the Society for Maternal-Fetal Medicine
On behalf of SMFM, I am pleased to submit testimony in support of
the important work related to optimizing the health of birthing people
and infants being conducted at HHS for FY 2022. SMFM urges Congress to
ensure that the National Institutes of Health (NIH), Centers for
Disease Control and Prevention (CDC), Health Resources and Services
Administration (HRSA), and Agency for Healthcare Research and Quality
(AHRQ) are adequately funded in FY 2022. Specifically, SMFM urges the
Committee to provide at least the following in base program level
funding:
--$46.1 billion for the NIH, with $1.7 billion of that funding to
support the Eunice Kennedy Shriver National Institute of Child
Health and Human Development (NICHD);
--$10 billion for the CDC, including $89 million for the Safe
Motherhood Initiative, $100 million for the Surveillance for
Emerging Threats to Moms and Babies initiative, and $200
million for the National Center for Health Statistics (NCHS);
--$9.2 billion for the HRSA, including $822.7 million for the Title V
Maternal and Child Health Services Block Grant; and
--$500 million for AHRQ.
Established in 1977, SMFM is the national voice for clinicians and
researchers with expertise in high-risk pregnancies. A non-profit
association representing more than 5,000 individuals, the core of
SMFM's membership is comprised of maternal-fetal medicine (MFM)
subspecialists. MFM subspecialists are obstetricians with an additional
three years of formal education and who are board certified in MFM
making them highly qualified experts and leaders in the care of
complicated pregnancies. Additionally, SMFM welcomes physicians in
related disciplines, nurses, genetic counselors, ultrasound
technicians, MFM administrators, and other individuals working toward
optimizing the care of people with high-risk pregnancies. SMFM members
see the most at-risk and complex patients, with the goal of optimizing
outcomes for pregnant people and their children.
NIH/NICHD
The NICHD's investment in maternal and child health outcomes is
essential to understanding and combatting the rising maternal mortality
and severe morbidity rates and to optimizing maternal and child health.
Task Force Specific to Pregnant Women and Lactating Women (PRGLAC):
SMFM urges Congress to continue its strong support for NIH's efforts to
advance the inclusion of pregnant and lactating people in clinical
trials and research, specifically by taking necessary steps to
implement the recommendations of the PRGLAC Task Force, which was
convened by NICHD. PRGLAC submitted its report to the Secretary in the
fall of 2018 with 15 recommendations on including pregnant and
breastfeeding people in clinical trials and broad research initiatives,
and the Task Force further outlined how to implement those
recommendations in a follow-up report submitted to the Secretary of
Health and Human Services in 2020. In that implementation report, the
PRGLAC Task Force described the need to convene an expert panel to
develop a framework for addressing medicolegal and liability issues
when planning or conducting research specific to pregnant people and
lactating people. SMFM requests $1.5 million for NICHD to contract with
the National Academies of Sciences, Engineering, and Medicine to
convene a panel tasked with developing that framework (language below).
The COVID-19 pandemic again emphasized the importance of including
pregnant and lactating people in clinical research. This population was
largely excluded from clinical trials for treatments and vaccines,
leaving them and their health care providers without clear evidence on
safety and efficacy to guide clinical decision-making. It is essential
that Congress support broader inclusion of pregnant and lactating
people in research, so that lifesaving interventions and treatments can
be addressed for mother and their infants.
NICHD Report Language
Liability Study.--Pregnant and Lactating Individuals. The
Committee includes $1,500,000 for NICHD to contract with NASEM
to convene a panel with specific legal, ethical, regulatory,
and policy expertise to develop a framework for addressing
medicolegal and liability issues when planning or conducting
research specific to pregnant people and lactating people.
Specifically, this panel should include individuals with
ethical and legal expertise in clinical trials and research;
regulatory expertise; plaintiffs' attorneys; pharmaceutical
representatives with tort liability and research expertise;
insurance industry representatives; federally funded
researchers who work with pregnant and lactating women;
representatives of institutional review boards (IRBs) and
health policy experts.
Maternal-Fetal Medicine Units Network (MFMU): SMFM urges continued
strong support of the MFMU and asks that Congress allocate $30 million
to support the Network's ongoing work. Established in 1986, MFMU
pursues the development of treatments for medical complications during
and after pregnancy, including maternal mortality and morbidity,
preterm birth, low birth weight, fetal growth abnormalities, and fetal
mortality. MFMU is a critical resource to stemming the nation's growing
maternal health crisis and addressing emerging threats to maternal and
infant health. For instance, during the COVID-19 pandemic, the MFMU was
able to quickly pivot resources to monitor the health impact of COVID-
19 on pregnant people and their infants, as well as researching
effective treatments for pregnant populations. We hope that the NICHD
will ensure the MFMU's continued success by maintaining its highly
efficient structure of multicenter collaborative research. The MFMU has
a strong history of changing and improving clinical practice and
obstetric management, improving outcomes of pregnant people and babies
in the United States, and is extremely successful. 25.6 percent of all
publications from the network are cited in clinical practice
guidelines. These guidelines are relied upon by Medicaid and Medicare
programs to define evidence-based services covered under the plans. The
work of the network is even more urgent given the recent increase in
maternal mortality and severe morbidity in the United States. We urge
Congress to ensure stable and sustained funding and infrastructure for
the MFMU, and to ensure that any proposed change in the funding
mechanism or structure for the MFMU not compromise the ability of the
network to remain nimble and directly address the changing landscape of
women's health, including to reduce health disparities.
Preterm Birth: Delivery before 37 weeks gestation is associated
with increased risk of death in the immediate newborn period as well as
in infancy and can cause long-term complications. Although the survival
rate is improving, many preterm infants have life-long disabilities
including cerebral palsy, intellectual disabilities, respiratory
problems, and hearing and vision impairment. Preterm birth costs the
United States $25.2 billion annually.\1\ Great strides are being made
through NICHD-supported research to address the complex situations
faced by mothers and their babies. One of the most successful
approaches for testing research questions is the NICHD research
networks, which allow researchers from across the country to
collaborate and coordinate their work to change the way we think about
pregnancy complications and to change medical practice across the
country.
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\1\ Waitzman NJ and Jalali A. Updating National Preterm Birth Costs
to 2016 with Separate Estimates for Individual States. Salt Lake City,
UT: University of Utah; 2019. Available at: https://
www.marchofdimes.org/peristats/documents/Cost_of_Prematurity_2019.pdf.
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CDC
The CDC's Division of Reproductive Health (DRH) and National Center
for Birth Defects and Developmental Disabilities (NCBDDD) are doing
important work related to pregnancy. Data collection efforts related to
pregnancy outcomes, maternal mortality, and medications in pregnancy
must continue.
For instance, CDC's ongoing support for state-based perinatal
quality collaboratives and new funding for state maternal mortality
review committees (MMRCs) is essential to address the nation's
unacceptable maternal death rate. According to the NCHS, the maternal
mortality rate in 2019 was 20.1 deaths per 100,000 live births, and
racial disparities persisted with a maternal mortality rate of 44.0 per
100,000 live births among non-Hispanic black women compared to 17.9
among non-Hispanic white women.\2\ SMFM fully supports Congress'
attention to reducing maternal mortality through CDC's Safe Motherhood
Initiative, and we ask that you provide at least $89 million for this
work. Of that, we ask Congress to allocate the full $43 million
included in the President's FY 2022 budget request to fund additional
state MMRCs.
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\2\ Hoyert DL. Maternal mortality rates in the United States, 2019.
NCHS Health E-Stats. 2021.Available at https://www.cdc.gov/nchs/data/
hestat/maternal-mortality-2021/maternal-mortality-2021.htm.
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SMFM also urges Congress to allocate $100 million for the CDC's
Surveillance for Emerging Threats to Moms and Babies initiative housed
at the NCBDDD. The state-level surveillance infrastructure supported by
the initiative allows state public health departments to monitor health
threats stemming from maternal exposures, including infectious diseases
such as COVID-19.
HRSA
The work of HRSA is critical to maternal and child health. HRSA's
initiatives reduce infant mortality, improve maternal health and
wellbeing, and serve more than 50 million people through the Maternal
and Child Health (MCH) Block Grant. The funds provided through the MCH
Block Grant increase access to comprehensive prenatal and postnatal
care--especially for patients who are most at risk for adverse health
outcomes. The Title V MCH Block Grant programs save federal and state
governments money by expanding the delivery of preventive services to
avoid more costly chronic conditions later in life. Additionally,
HRSA's family planning initiatives ensure access to comprehensive
family planning and preventive health services for more than 4 million
people, thereby reducing unintended pregnancy rates. Finally, HRSA's
support for the Alliance for Innovation in Maternal Health Care (AIM)
reduces maternal mortality through implementation of care bundles at
the state and institutional level. These bundles help reduce maternal
mortality through quality improvement in various areas including
postpartum hemorrhage and hypertension. We encourage Congress to
provide at least $822.7 million for this important program that will
help improve maternal and infant health across the United States.
AHRQ
Projects conducted at AHRQ are critical to translate research from
bench to bedside through comprehensive implementation in the everyday
practice of medicine. AHRQ is the only federal agency that funds
research on ``real-life'' patients--those with comorbidities and co-
existing conditions, including high-risk pregnant people. The agency's
work is instrumental in collecting data; funding health services
research; and, most importantly, disseminating findings to clinicians
to improve maternal health care. Together, AHRQ's intramural programs,
such as the Healthcare Cost and Utilization Project (HCUP), Evidence-
Based Practice Center Program and Safety Program in Perinatal Care, and
extramural research are essential to reducing maternal deaths and
adverse pregnancy outcomes. By providing at least $500 million to AHRQ
in FY 2022, Congress will allow AHRQ to expand its maternal health
portfolio, improving care for nearly 4 million pregnant patients each
year.
conclusion
The COVID-19 pandemic has further exposed existing inequities and
gaps within our healthcare system for people across the country,
including pregnant people. It is more important than ever to prioritize
the needs of pregnant people and their infants in federal programs from
research, to public health surveillance, to care. We urge HHS to
prioritize and adequately fund maternal health efforts for that aim to
reduce maternal mortality and severe morbidity during and after the
pandemic.
With your support of vital HHS programs, obstetric researchers,
clinicians, and patients can address the complex problems of pregnancy
and truly improve the health and wellbeing of mothers and infants.
Please direct any inquiries about this testimony to Rebecca Abbott,
SMFM's Director of Government Relations ([email protected]).
______
Prepared Statement of the Society for Neuroscience
Chair DeLauro, Ranking Member Cole, and members of the
Subcommittee, on behalf of the Society for Neuroscience (SfN), we are
honoured to present this testimony in support of robust appropriations
for biomedical research at the National Institutes of Health (NIH). SfN
urges you to provide at least $46.1 billion, a $3.2 billion increase
over FY21, in funding for existing institutes and centers at NIH for
FY22, including $496 million from the NIH Innovation Account for 21st
Century Cures programs and $560 million for the Brain Research through
Advancing Innovative Neurotechnologies (BRAIN) Initiative. Dr. Moses
Chao and I, as Chair of the Government and Public Affairs Committee and
President of SfN respectively, understand the critical importance of
federal funding for neuroscience research in the United States. I
currently serve as a researcher and as a Professor in the Department of
Psychology at Cambridge University and Dr. Chao is a professor of Cell
Biology, Physiology and Neuroscience, and Psychiatry at the New York
University School of Medicine. Our research serves as two examples of
the wide variety of neuroscience research advancing our collective
understanding of the brain.
My own research focuses on the neural and psychological basis of
drug addiction and is dedicated to understanding the maladaptive
engagement of the learning, memory, and motivational mechanisms
underlying compulsive drug use. Drug abuse and addiction have
devastating consequences at the individual, family, and society levels.
My research group made significant advances in showing structural and
neurochemical changes in the brain associated with behavioral
impulsivity confer a major risk on vulnerability to develop cocaine
addiction. We have also demonstrated the neural circuit basis of
transition from recreational to compulsive use of opioids, stimulants,
and alcohol, revealing commonalities as well as differences in the
neural basis of addiction to these drugs. This understanding has opened
the door to development of novel pharmacological and psychological
treatments for addiction that may promote and maintain abstinence from
drug use.
Dr. Chao's research efforts focus on growth factors (also called
neurotrophins) in the brain. These proteins are crucial for everything
from neuron differentiation, growth, and survival during development to
learning and memory in children and adults. Deficits in neurotrophins
are involved in neurodegenerative disorders such as Alzheimer's,
Parkinson's and Huntington's diseases, and Amyotrophic Lateral
Sclerosis (ALS), as well as limiting recovery after stroke or brain
injury.
Dr. Chao and I cover different areas of neuroscience research,
though we have come together to convey the need for further and ongoing
investment in neuroscience research. SfN believes strongly in the
research continuum: basic science leads to clinical innovations, which
leads to translational uses impacting the public's health. Basic
science is the foundation upon which all health advances are built. To
cure diseases, we need to understand them through fundamental
discovery-based research. However, basic research depends on reliable,
sustained funding from the federal government. SfN is grateful to
Congress for its investments in biomedical research and increases for
NIH over the last six years. Growing the NIH budget over $12 billion in
that period is exactly the kind of sustained effort that is needed, and
your continued support will pay dividends for years to come.
the importance of the research continuum
NIH funding for basic research is critical for facilitating
groundbreaking discoveries and for training researchers at the bench.
For the United States to remain a leader in biomedical research,
Congress must continue to support basic research that fuels discoveries
as well as the economy. The deeper our grasp of basic science, the more
successful those focused on clinical and translational research will
be. We use a wide range of experimental and animal models not used
elsewhere in the research pipeline. These opportunities create
discoveries--sometimes unexpected discoveries--expanding knowledge of
biological processes, often at the molecular level. This level of
discovery reveals new targets for research to treat all kinds of brain
disorders affecting millions of people in the United States and beyond.
NIH basic research funding is also a key economic driver of science
in the United States through funding universities and research
organizations across the country. Federal investments in scientific
research fuel the nation's pharmaceutical, biotechnology and medical
device industries. The private sector utilizes basic scientific
discoveries funded through NIH to improve health and foster a
sustainable trajectory for American's Research and Development (R&D)
enterprise. Basic science generates the knowledge needed to uncover the
mysteries behind human diseases, which leads to private sector
development of new treatments and therapeutics. This important first
step is not ordinarily funded by industry given the long-term path of
basic science and the pressures for shorter-term return on investments
by industry. Congressional investment in basic science is irreplaceable
on the pathway for development of drugs, devices, and other treatments
for brain-related diseases and disorders.
For example, in 2019, NIH launched--at Congress's direction--the
cross-institute Helping to End Addiction Long-term (HEAL) Initiative to
respond to the ongoing opioid public health crisis. Through this
program, NIH supports the development of new medications to treat all
aspects of the opioid addiction cycle and invests in preclinical and
translational research in pain management. This work is vital to the
translation of exciting new discoveries in the treatment of addiction.
In our lab, we have shown a novel opioid receptor antagonist greatly
decreases opioid, cocaine, and alcohol use in animal models, as well as
showing its efficacy and safety in experimental studies in humans. We
have further revealed reducing the impact of maladaptive drug memories
can promote abstinence from drug use, as well as be effective in
treatment of anxiety disorders and post-traumatic stress disorder
(PTSD). The NIH, especially NIDA and NIAAA, supports the great majority
of the global research on addiction and its treatment; this is a
shining example of how governmental funding for research in the US
leads the world and inspires related and collaborative research
internationally on this major brain disorder.
Another example of NIH's success in funding neuroscience is the
BRAIN Initiative. While only one part of the research landscape in
neuroscience, the BRAIN Initiative has been critical in promoting
future discoveries across neuroscience and related scientific
disciplines. By including funding in 21st Century Cures, Congress
helped maintain the momentum of this endeavor. Note, however, using
those funds to supplant regular appropriations would be
counterproductive. There is no substitute for robust, sustained, and
predictable funding for NIH. SfN appreciates Congress' ongoing
investment in the BRAIN Initiative and urges its full funding in FY22.
Some recent exciting advancements in NIH funded neuroscience research
include the following:
Personalized Medicine for Treating Depression
Major depressive disorder (often referred to as ``depression'') is
one of the most common mental disorders in the United States, affecting
more than 17 million adults each year in the United States alone. While
there have been great strides in pharmacological treatments for
depression, a patient's response to any given antidepressant will vary
widely based on their particular brain chemistry. A group of
researchers funded by NIH recently used a machine learning algorithm to
analyze patients' brain waves and predict their response to sertraline,
a popular antidepressant. These data were taken from an NIMH funded
study that used electroencephalography (EEG) to measure the brain's
response to taking either a placebo or sertraline. Using an algorithm
specially designed to analyze EEG data, the researchers were able to
predict whether patients would respond to sertraline treatment based on
brain waves measured before treatment. This work is a critical step
towards quickly determining the most effective treatment for patients
based on their personal brain chemistry and illness.
Understanding How COVID Affects the Brain
In addition to its well-documented effects on the respiratory
system, it has become clear that SARS-CoV-2, the virus responsible for
COVID-19, has a profound effect on the brain, with neurological
symptoms from dizziness and mental fogginess to encephalitis and stroke
appearing in COVID-19 patients. SARS-CoV-2 has been found in the
cerebrospinal fluid (CSF) of some of these patients, indicating the
virus was able to cross into the brain. To understand how the virus
could enter the brain, researchers with NIH COVID-19 research funding
used stem cells created from human skin cells to make clusters of brain
cells called organoids. These organoids were made of cells found in
different areas of the brain, and the researchers found that SARS-CoV-2
had a high infection rate for cells from a specialized region called
the choroid plexus. The choroid plexus is the region of the brain that
creates the CSF cushioning the brain and spinal cord; it is known as a
site of infection for other viruses. This finding provides a lead on
the location through which SARS-CoV-2 may be entering the brain and a
potential target for developing treatments of the neurological effects
of COVID-19.
covid-19 is a challenge and opportunity for neuroscience research
Unfortunately, the COVID-19 pandemic slowed progress in
neuroscience research, with social distancing requirements hampering
ongoing research related to the brain. Investment in neuroscience
research, including on the neurological aspects of the SARS-CoV-2 virus
and the COVID-19 pandemic itself is needed but cannot be allowed to
eclipse or replace regular funding for neuroscience research. We urge
you to identify ways to ensure current necessary funding increases to
address the COVID-19 emergency do not slow progress on other important
and innovative research, including the groundbreaking research in
neuroscience and mental health. SfN is grateful Congress requested NIH
seek to understand the psychosocial and behavioral health consequences
of COVID-19. SfN encourages the Subcommittee to fund basic research on
the biology of COVID-19 impacts on brain function as well as impacts on
the nervous system in preclinical models and, by extension, on humans.
In doing so, SfN encourages Congress and the NIH to prioritize
intentional collaboration and coordination to effectively allocate
scarce resources so researchers may investigate all facets of
infectious and non-infectious disease.
Ongoing research already demonstrates the need for scientists to
examine the neurological impacts of COVID-19. While mortality due to
SARS-CoV-2 may be primarily due to its effects on the lungs, it is now
apparent the virus damages many other organs, including the central
nervous system. We need to understand how these direct and indirect
effects on other organ systems are producing chronic diseases and long-
term disability, making people more susceptible to other chronic
disorders covered by the different NIH Institutes. A recent study
(Lancet article, Taquet et al 2020) shows an increased risk of
psychiatric conditions after COVID-19 diagnosis. Symptoms, such as
anxiety, depression, post-traumatic stress disorder, and insomnia were
reported. These data, though incomplete, suggest brain impairment
occurs as a result of COVID-19 infection. Furthermore, it was found
people with two copies of the risk gene for Alzheimer's disease were
more likely to have severe COVID-19 (Kuo et al J. Gerontology 2020).
These findings, coupled with incidents of memory loss, brain fog and
hallucinations reported in the New York Times (3/23/21) demand
increased resources to study the impact of this virus on the peripheral
and central nervous systems, as well as the immune and inflammatory
systems. The COVID-19 public health emergency provides an important
example of the critical need for collaborative research and
coordinating data and resources across institutes. A balanced and
collaborative research effort across institutes will likely be the path
toward solving these multiple issues.
congress & nih must support access to models necessary for neuroscience
discovery
Adequate NIH funding is necessary to advancing our understanding of
the brain; however, full realization of this funding's promise requires
appropriate access to research models, including non-human primate and
other animal models. Animal research is highly regulated to ensure the
ethical and responsible care and treatment of the animals. SfN and its
members take their legal and ethical obligations related to this
research very seriously. While SfN recognizes the goal of the
reduction, refinement, and eventual replacement of nonhuman primate
models in biomedical research, much more research and time is needed
before such a goal is attainable. Premature replacement of non-human
primate and other animal models may delay or prevent the discovery of
treatments and cures-not only for neurological diseases like
Alzheimer's disease, addiction, and traumatic brain injury, but also
for communicable diseases and countless other conditions. There are
currently no viable alternatives available for studying biomedical
systems that advance our understanding of the brain and nervous system;
or when seeking treatments for diseases and disorders like depression,
addiction, Parkinson's Disease, and emotional responses. This research
is critically important and has the opportunity to benefit countless
people around the world. SfN urges Congress to work with the NIH to
ensure this important research can continue.
funding in regular order
SfN joins the biomedical research community supporting an increase
in NIH funding to at least $46.1 billion for existing NIH institutes
and centers, a $3.2 billion increase over FY21. This increase is
consistent with those provided by this committee for the past few years
and provides certainty to the field of science, allowing for the
exploitation of more scientific opportunity, more training of the next
generation of scientists, more economic growth and more improvements in
the public's health. Equally as important as providing a reliable
increase in funding for biomedical research is ensuring funding is
approved before the end of the fiscal year. Your success in 2018 in
completing appropriations prior to the start of the fiscal year was a
tremendous benefit to research. Continuing Resolutions have significant
consequences on research, including restricting NIH's ability to fund
grants. For some of our members, this means waiting for a final
decision to be made on funding before knowing if their perfectly scored
grant will be realized, or operating a lab with 90 percent of the
awarded funding until appropriations are final. All of the positive
benefits research provides in this country may be negatively impacted
by these real time considerations. SfN strongly supports the
appropriation of NIH funding in a timely manner which avoids delays in
approving new research grants or causes reductions in funding for
already approved research funding. Meeting the example Congress set in
2018 would be another substantial benefit to science.
SfN thanks the subcommittee for your strong and continued support
of biomedical research and looks forward to working with you to ensure
the United States remains the global leader in neuroscience research
and discovery. Collaboration among Congress, the NIH, and the
scientific research community has created great benefits for not only
the United States but also for people around the globe suffering from
brain-related diseases and disorders. On behalf of the Society for
Neuroscience, we urge you to continue this strong support of biomedical
research.
[This statement was submitted by Barry Everitt, Sc.D., F.R.S.,
President, and Moses Chao, PhD, Chair, Government and Public Affairs
Committee, Society for Neuroscience.]
______
Prepared Statement of the Society for Women's Health Research
On behalf of the Society for Women's Health Research (SWHR)--whose
mission is dedicated to promoting research on biological sex
differences in disease and improving women's health through science,
policy, and education--I am pleased to submit testimony describing
SWHR's funding requests for fiscal year 2022. While SWHR supports
strong funding across all federal public health programming, we
specifically urge appropriators to support at least $46.1 billion for
the National Institutes of Health (NIH), including at least $1.7
billion for the Eunice Kennedy Shriver National Institute of Child
Health and Human Development (NICHD), and $55.4 million for the Office
of Research on Women's Health (ORWH).
Biological differences between women and men influence disease
development, progression, and response to treatment, while social
determinants of health, including gender, affect disease risk, health
care access, and outcomes.
Over the past 15 months, as the world has collectively faced the
myriad consequences of the COVID-19 pandemic, we have also seen an
array of health disparities exposed, including significant sex and
gender differences. For example, men are more likely to develop severe
complications from COVID-19 and have a heightened risk of death, while
women are more likely to be diagnosed with post-acute sequelae of
COVID-19 and report more adverse events following vaccination.
Additionally, women have been disproportionately affected by layoffs
and socioeconomic challenges, food insecurity, domestic violence, and
mental health concerns related to COVID-19.
Nevertheless, much of the ongoing COVID-19 research fails to
thoroughly investigate the impact of sex and gender. We have long known
that robust funding for federal institutes and offices that prioritize
women's health research is critical to achieve health equity for women.
Therefore, SWHR urges Congress to prioritize women's health and women's
health research in FY 2022 funding legislation, which includes
supporting the NIH, ORWH, and NICHD.
the national institutes of health
The NIH is America's premier medical research agency and the
largest source of funding for biomedical and behavioral research in the
world. As such, its public health mission is vital to promote the
overall health and well-being of Americans by fostering creative
discoveries and innovative research, training and supporting
researchers to ensure continued scientific progress, and expanding the
scientific and medical knowledge base.
Within the NIH, there are several initiatives aimed at improving
the health of women. Among these initiatives was the agency's Trans-NIH
Strategic Plan for Women's Health Research, released in April 2019. The
Strategic Plan laid out broad NIH goals that complement its more
targeted women's health programs. These initiatives--along with the
NIH's continued emphasis on improving standard research methodologies
to address sex and gender and providing funding for women's health
research--make continued support of NIH necessary in our mission to
support women's health.
SWHR urges Congress to provide at least $46.1 billion for the NIH,
a $3.2 billion increase over current funding, in FY 2022. This funding
level would sustain and bolster NIH's ability to award competitive
research grants, support the work of researchers within NIH, and build
upon efforts to mitigate the COVID-19 pandemic's impact on ongoing and
future research. We also encourage the Committee to work with NIH to
ensure that the agency studies the impact of COVID-19, including the
race and gender breakdown of participation in the workforce in the wake
of the pandemic and how sex as a biological variable impacts short- and
long-term health outcomes due to infection with SARS-CoV-2.
the office of research on women's health
For decades, and as late as the 1990s, women were treated as small
men in research. Research on diseases and treatments were conducted
almost exclusively on male subjects, as researchers sought to avoid the
presumed ``complications'' introduced by including female subjects in
their work. Unfortunately, this approach ignored the impact of sex and
gender on human development, disease progression, and ultimately, on
approaches to research as a whole.
As the NIH focal point for coordinating women's health research,
ORWH ensures women are represented across all NIH research and works to
improve representation of women and women's health issues within
federally funded research. ORWH provides critical leadership to
programs, such as the Specialized Centers of Research Excellence, which
advances translational research on the role of sex differences in the
health of women, and the Implementing a Maternal health and Pregnancy
Outcomes Vision for Everyone (IMPROVE) Initiative, which coordinates
interdisciplinary research on factors impacting maternal mortality.
In order to allow the Office to continue to coordinate and drive
the conversation on women's health across NIH, SWHR recommends $55.4
million in funding for ORWH, an increase on par with the overall NIH
budgetary recommendations, for FY 2022. SWHR also recommends an
additional $3 million be allocated to the Building Interdisciplinary
Research Careers in Women's Health program, an initiative that trains
investigators to research sex and gender influences on health. This
program has the potential not only to improve women's health by
advancing our understanding of sex and gender differences, but also to
support a diverse research workforce.
eunice kennedy shriver national institute of child health and human
development
The NICHD provides a home for women's health research in areas
including reproductive sciences and maternal health. While the
Institute is conducting several areas of critical research, there are
two key areas of need within NICHD that could be further supported
through additional funding in FY 2022:
Pregnant and Lactating Individuals: Nearly 94% of women take at
least one medicine during pregnancy, and 50% take at least one
medication during the postpartum period. Yet, pregnant and lactating
individuals are excluded from the majority of biomedical research.
Consequently, these women and their health care providers do not have
access to the information they need to make confident decisions about
their health care.
SWHR supports the appropriate inclusion of these populations in
clinical research. The federal Task Force on Research Specific to
Pregnant Women and Lactating Women, housed within the NICHD, has been
crucial to outlining next steps for improving research in pregnant and
lactating populations. Based on the Task Force recommendations from
August 2020, SWHR requests that Congress include report language
recommending that NICHD contract with the National Academy of Medicine
to convene a panel with specific legal, ethical, regulatory, and policy
experts to develop a framework for addressing legal and liability
issues in research specific to pregnant and lactating people.
Uterine Fibroids: There is also need for improved attention to
uterine fibroids, one of the most common gynecological conditions
nationwide. Approximately 26 million individuals in the United States
from ages 15 to 50 have fibroids, and 15 million experience symptoms
like severe menstrual bleeding, anemia, impaired fertility, and
pregnancy complications. Fibroids cost the health care system $5.9 to
$34.4 billion annually.
Additionally, prominent and troubling health disparities exist in
fibroids prevalence, onset, and severity. Black women are two to three
times more likely to develop fibroids than white women. Black patients
also tend to develop fibroids at earlier ages, develop more and larger
tumors, and show increased symptom severity.
Yet, despite the prevalence of fibroids, fibroid research remains
drastically underfunded compared to disease burden. In 2019, fibroid
research received about $17 million in NIH funding, putting it in the
bottom 50 of 292 funded conditions.
SWHR calls on Congress to provide at least $1.7 billion for NICHD
in FY 2022 and to urge the NICHD to prioritize funding to expand basic,
clinical, and translational research pathophysiology to identify early
diagnostic methods and fertility-preserving treatments and to
understand and mitigate the impact of health disparities.
****
The Society for Women's Health Research appreciates the opportunity
to submit this testimony and thanks the Subcommittee for considering
our requests of at least $46.1 billion for NIH, $55.4 million for ORWH,
and at least $1.7 billion for NICHD. We look forward to working with
you to support medical and health services research and, therein, the
health of the nation. If you have questions or would like more
information, please do not hesitate to contact me at [email protected].
[This statement was submitted by Kathryn G. Schubert, President &
CEO,
Society for Women's Health Research.]
______
Prepared Statement of the Society of Gynecologic Oncology
The Society of Gynecologic Oncology thanks the Subcommittee for the
opportunity to submit comments for the record regarding our report
language recommendations for prioritizing research activities on
gynecologic cancers at the NIH National Cancer Institute in Fiscal Year
2022. The Society of Gynecologic Oncology (SGO) is the premier medical
specialty society for health care professionals trained in the
comprehensive management of gynecologic cancers. The SGO's 2,000
members in the United States and abroad represent the entire
gynecologic oncology team dedicated to the treatment and care of
patients with gynecologic cancers. The SGO's strategic goals include
advancing the prevention, early diagnosis, and treatment of gynecologic
cancers by establishing and promoting standards of excellence. Key
priorities for the SGO are to advocate for more equitable care for all
patients and support research aimed to improve outcomes for diverse
patient populations.
Gynecologic cancers are cancers that start in a patient's
reproductive organs. There are five types of gynecologic cancers:
cervical cancer, ovarian cancer, uterine also referred to as
endometrial cancer, vaginal cancer, and vulvar cancer. Cervical,
ovarian, and uterine cancers have both the highest incidence and
mortality rates of all the gynecologic cancers.
The American Cancer Society estimates that this year in the United
States over 100,000 people will be diagnosed with gynecologic cancers,
including 66,570 new cases of uterine cancer, 21,410 cases of ovarian
cancer, and 14,480 new cases of cervical cancer. More than 30,000
people will die from these malignancies, including 12,940 deaths from
uterine cancer, 13,770 deaths from ovarian cancer, and 4,290 deaths
from cervical cancer.
What is most alarming is the American Cancer Society's Annual
Report to the Nation on the Status of Cancer, 1975-2014, which compared
overall cancer survival rates from 1975-1977 and from 2006-2012 and
reported that survival rates increased significantly for all but two
cancer types in women, cancer of the cervix and of the uterus.
Furthermore, there are significant health disparities among
patients who are diagnosed with these cancers. Despite overall declines
in cervical cancer mortality in the U.S. over the past 6 decades,
racial and socioeconomic disparities continue to exist in cervical
cancer screening, incidence, and mortality, resulting in a
disproportionate impact on low-income patients and patients of color.
Hispanic patients are most likely to get cervical cancer, followed by
African Americans, American Indians and Alaskan natives, and Whites.
Hispanic patients are sixty percent (60%) more likely to be diagnosed
with and thirty percent (30%) more likely to die from cervical cancer
than white patients. Black patients are approximately twice as likely
to die of cervical cancer. Socioeconomic status plays a role in these
disparities. Patients living below the poverty level and without a high
school education are 4.9 and 6.3 times more likely to die of cervical
cancer than patients with the highest income and education levels,
respectively. As concerning as these figures remain, they may in fact
represent an underestimation of the problem especially in black
patients. A patient that is diagnosed with invasive cervical cancer
often reflects a patient who did not have access to or failed to
receive a Pap smear test.
Uterine or endometrial cancer is the most common gynecological
cancer, and the fourth most common malignancy among women in the United
States. There are significant racial disparities in endometrial cancer
as well. Endometrial cancer has been reported to be thirty-one percent
(31%) lower among black patients compared to white patients. However,
both black and Hispanic patients are less likely to receive evidenced
based care. These racial disparities in treatment likely contribute to
racial disparities in outcome. The age-adjusted mortality among black
patients is approximately 84% higher.
Disparities in access to genetic testing, preventive services, and
other aspects of providing care for patients with gynecologic cancers
are creating enormous inequities in outcomes and survivorship in our
health care system, particularly for endometrial cancer and cervical
cancer. Research is needed to help understand barriers to screening
programs, discover new approaches to screening, and promote wider
implementation of known strategies to facilitate optimal treatments and
improved mortality for minority populations with these diseases.
The SGO urges the Subcommittee to adopt the following report
language focused on gynecologic cancers in the report accompanying the
Fiscal Year 2022 Labor-HHS-Education appropriations bill.
National Institutes of Health
National Cancer Institute
Gynecologic Cancers.--The Committee continues to be concerned about
the growing racial, socioeconomic, and geographic disparities in
gynecologic cancers. In contrast to most other common cancers in the
United States, relative survival for women with newly diagnosed
advanced cervical or endometrial cancer has not significantly improved
since the 1970s.\1\ Furthermore, historical data demonstrates that
Black and Latinx women with gynecologic cancers are not as likely to
receive standard therapy and/or die more frequently.\2\ The current
COVID-19 pandemic has only exacerbated the health care disparities that
were already present in minority and underrepresented communities. For
example, in early 2021 the Centers for Disease Control (CDC) published
findings that cervix cancer screenings in California decreased by as
much as 78% during the pandemic--and have not recovered. They
specifically noted concern because ``cervical cancer incidence and
mortality rates are disproportionately higher in Hispanic women and
non-Hispanic Black women.'' \3\ Therefore, the Committee urges the NCI
to expand the number of program projects, clinical trials, research
grants, and contract opportunities for investigators that focus on
discoveries that will positively impact access to prevention, early
detection, diagnosis, and treatment for gynecologic cancers and address
these now well documented disparities. Accelerated progress in reducing
gynecologic cancer mortality has been a need for some time. The
Committee requests an update on NCI's research program for gynecologic
cancers in the fiscal year 2023 Congressional Budget Justification,
including specific grants and strategies where the intent is to
overcome these racial disparities in gynecologic cancers outcomes,
including the underrepresentation of minority women in gynecologic
cancer clinical trials.
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\1\ Jemal A, et al. Annual report to the nation on the status of
cancer, 1975-2014, featuring survival. J Natl Cancer Inst 2017; 109(9):
djx030.
\2\ Rauh-Hain JA, et al. Racial and ethnic disparities over time in
the treatment and mortality of women with gynecological malignancies.
Gynecol Oncol 2018; 149(1): 4-11.
\3\ Miller MJ, et al. Impact of COVID-19 on cervical cancer
screening rates among women aged 21-65 years in a large integrated
health care system. CDC Morbidity and Mortality Weekly Report. January
29, 2021; 70(4): 109-113.
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Thank you in advance for your favorable consideration of this
report language request. The SGO believes that pursuit of these
important research objectives will help alleviate disparities in
prevention, diagnosis, treatment, and survivorship of gynecologic
cancers, benefitting minority patients and all patients who are
impacted by these diseases.
______
Prepared Statement of the Society of Nuclear Medicine and
Molecular Imaging
Madam Chair and members of the Subcommittee, I am Richard L. Wahl,
MD, President of the Society of Nuclear Medicine and Molecular Imaging
and the Elizabeth E. Mallinckrodt Professor and head of radiology at
Washington University School of Medicine in St. Louis, MO.
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) is a
nonprofit scientific and professional organization that promotes the
science, technology, and practical application of nuclear medicine and
molecular imaging. Research in this field has led to breakthroughs for
diagnosing and treating patients with deadly conditions such as cancer,
heart disease, and Alzheimer's disease. SNMMI strives to be a leader in
unifying, advancing, and optimizing molecular imaging, with the
ultimate goal of improving human health through noninvasive procedures
and therapeutic approaches utilizing internally-administered
radiopharmaceuticals. With over 15,000 members worldwide, SNMMI
represents nuclear medicine and molecular imaging professionals,
including physicians, physicists, radiochemists, pharmacists, and
technologists, all of whom are committed to the advancement of the
field. It is my pleasure to submit this testimony on behalf of SNMMI.
We strongly support the President's request of $52 billion for the
National Institutes of Health and ask that no less than $46.111 billion
of that be for the NIH's base program budget for FY2022.
Moreover, SNMMI supports a proportional increase to the National
Institute of Biomedical Imaging and Bioengineering (NIBIB), resulting
in at least $441.1 million for FY2022--a $30.4 million increase over
FY2021. These base increases reflect approximately 5% above the
biomedical research and development price index (BRDPI). Through
consistent, strong funding for NIH and our national research
infrastructure we can continue to make advancements that will improve
the lives of patients with a wide spectrum of diseases and disorders.
SNMMI is grateful for the Subcommittee's past support of NIH and
encourages the Subcommittee to continue advancing discovery and
innovation in nuclear medicine and molecular imaging.
Nuclear medicine, in particular, is undergoing a renaissance as a
precision medicine specialty, with new radiopharmaceuticals,
radiopharmaceutical therapies, and instrumentation to elucidate biology
and benefit patients. Federal research funding allows our members,
partners, and stakeholders to improve imaging tools and therapies,
which, in turn, broadens the resources available to address many
challenging conditions. As a physician/clinician-scientist, my work has
been greatly impacted by NIH funding, resulting in 18 patents, over 450
peer-reviewed scientific manuscripts, and several FDA-approved
theranostic (therapy + diagnostics) drugs and devices. I use state-of-
the-art technologies like positron emission tomography (PET) combined
with computer tomography (CT) and other advanced imaging modalities to
improve the diagnosis and treatment of cancer types, including
prostate, breast, neuroendocrine, and pancreatic, while also
researching rare and orphan diseases.
nuclear medicine and molecular imaging: precise and personalized
medicine
Nuclear medicine and molecular imaging procedures are used in a
wide array of diseases and disorders, including cancer, Alzheimer's and
Parkinson's Diseases, and cardiac disease, among others.\1\ Congress's
support of NIH has helped to advance the science and the researchers
who make these discoveries. NIH support is often the foundation of the
newest technologies that go on to help patients. This subcommittee's
continued support of the NIH, especially the National Cancer Institute
(NCI), NIBIB, National Institute on Aging (NIA), National Institute of
Neurological Disorders and Stroke (NINDS), National Institute of Mental
Health (NIMH), and National Heart, Lung, and Blood Institute (NHLBI),
will help scientists address many unmet medical needs. Some of the
advances from the nuclear medicine and molecular imaging community in
detecting and treating cancer and selecting the right patient for the
right therapy are detailed below.
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\1\ Wahl RL, Chareonthaitawee P, Clarke B, Drzezga A, Lindenberg L,
Rahmim A, Thackeray J, Ulaner GA, Weber W, Zukotynski K, Sunderland J.
Mars Shot for Nuclear Medicine, Molecular Imaging, and Molecularly
Targeted Radiopharmaceutical Therapy. J Nucl Med. 2021 Jan;62(1):6-14.
doi: 10.2967/jnumed.120.253450. PMID: 33334911.
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Radiopharmaceutical Imaging and Therapy for Cancer
In the last month alone, two major advancements in the fight
against prostate cancer were in the news. Pylarify, a radioactive
imaging agent, was approved by FDA on May 27. This radiotracer seeks
out prostate cancer cells throughout the body so the active foci of
cancer can be seen on a PET/CT scan. This class of agents targeting
prostate specific membrane antigen or PSMA, can identify cancer months
or years ahead of standard imaging such as CT or MRI, allowing patients
to receive appropriate treatment sooner when it can be more effective.
One week later, the results from the VISION trial were announced. This
phase III trial enrolled men with late-stage castrate-resistant
prostate cancer that had spread and were treated with either a PSMA
targeting molecule with the radioisotope lutetium-177 (\177\Lu)
attached, or with the best standard of care. The PSMA part of the drug
acts like GPS to seek out prostate cancer cells. The attached lutetium-
177 radioisotope destroys the cancer cells while leaving healthy tissue
intact. Combined, the radiopharmaceutical therapy is in effect a
``smart bomb'' to selectively destroy foci of prostate cancer. The men
treated with \177\Lu-PSMA had a four-month longer median survival than
men receiving best standard of care alone. These results prompted FDA
to label the treatment as a breakthrough therapy which will accelerate
its approval time and allow it to reach patients in need faster. None
of this would have been possible without the early support of 13 NIH
grants.\2\
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\2\ Szabo Z, Mena E, Rowe SP, et al. Initial Evaluation of
[(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted
PET Imaging of Prostate Cancer. Mol Imaging Biol. 2015;17:565-574.
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Imaging and therapy molecule pairs, such as those using PSMA
molecules as targeting agents, are often referred to as theranostics, a
rapidly developing area of personalized medicine. If the diagnostic
version of the molecule can find the cancer with a PET scan, then the
same molecule with a therapeutic isotope can be used to attack the
cancer. Further advancements in the theranostics space are anticipated.
This treatment principle is being applied to cancer types for which we
have no or few treatment options, such as pancreatic cancer. An
exciting new class of theranostic molecules are those targeting
fibroblast-activation-protein (FAP).\3\ This protein (FAP) is
overexpressed in many cancer types including breast, pancreas, lung,
kidney, and ovarian. The FAP molecule can be labeled as a diagnostic
agent and then as a therapy. This treatment paradigm gives doctors a
new tool in the fight against cancer. The NCI is currently supporting a
phase 1 clinical trial (NCT04457258) on this promising new agent.
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\3\ Kratochwil C, Flechsig P, Lindner T, Abderrahim L, Altmann A,
Mier W, Adeberg S, Rathke H, Rohrich M, Winter H, Plinkert PK, Marme F,
Lang M, Kauczor HU, Jager D, Debus J, Haberkorn U, Giesel FL. 68Ga-FAPI
PET/CT: Tracer Uptake in 28 Different Kinds of Cancer. J Nucl Med. 2019
Jun;60(6):801-805. doi: 10.2967/jnumed.119.227967. Epub 2019 Apr 6.
PMID: 30954939; PMCID: PMC6581228.
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None of these advances would be possible without the support of
radiochemistry and isotope production research. The next generation of
radioisotopes, alpha emitting therapeutic isotopes, which have much
greater cancer killing power per radioactive decay, are in clinicals
trials and are expected to provide better patient outcomes. Support of
that research is critical.
Quantitative Molecular Imaging
A PET scanner is often thought of as an imaging tool; however, it
is inherently a highly specific measuring tool. Recent advances in PET
technology such as PET/MRI and total-body PET, where the whole body can
be imaged at once, have opened new research possibilities.\4\ To
realize the full potential of these advances, quantitative analysis
will be required to appreciate the sensitivity of the scanner and the
tracers it measures. The NCI has supported the harmonization of PET/CT
scanners through numerous grants including NIH R01CA169072, and for the
last decade, the NCI, through their Cancer Imaging Program has
developed and supported a consortium of academic sites called the
Quantitative Imaging Network performing and advancing quantitative
imaging mostly in support of clinical trials.
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\4\ Meikle SR, Sossi V, Roncali E, Cherry SR, Banati R, Mankoff D,
Jones T, James M, Sutcliffe J, Ouyang J, Petibon Y, Ma C, El Fakhri G,
Surti S, Karp JS, Badawi RD, Yamaya T, Akamatsu G, Schramm G, Rezaei A,
Nuyts J, Fulton R, Kyme A, Lois C, Sari H, Price J, Boellaard R, Jeraj
R, Bailey DL, Eslick E, Willowson KP, Dutta J. Quantitative PET in the
2020s: a roadmap. Phys Med Biol. 2021 Mar 12;66(6):06RM01. doi:
10.1088/1361-6560/abd4f7. PMID: 33339012.
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Imaging of the brain in Alzheimer Disease
In the past weeks, the FDA approved an innovative antibody therapy
for Alzheimer's disease which removes amyloid plaque from the brain. At
present, PET scanning using radiotracers that target the amyloid
protein or the abnormal tau protein seen in dementias of the Alzheimer
type have been key to identifying patients who may be suitable
candidates for such clinical trials and these emerging therapies. The
support of the NIH was key to developing these brain imaging agents and
continued NIH support is essential to allow PET to probe the earliest
changes of dementia and to monitor the effects of emerging innovative
therapies. There are now several FDA approved PET imaging agents to
identify patients with amyloid or tau deposition, helping identify how
to best target limited resources to patient groups most likely to
benefit from such therapies. The ability to select patients most likely
to respond to therapy is expected to save tens of billions in
healthcare dollars per year.
Immuno-oncology Imaging
In 1980, the NCI added $13.5M to their budget for new Biological
Response Modifiers, this triggered a search for agents able to modify a
body's response to tumor cells.\5\ That investment spawned the multi-
billion-dollar drug class of immune checkpoint inhibitors (ICI),
starting with the approval of Yervoy (ipilumimab) in 2011. In the US
in 2020, a year severely impacted by the COVID-19 pandemic, sales of
the top three ICI topped $17B. ICIs are generally considered to be safe
and effective treatment options for numerous cancer types including
lung cancers and melanoma, and some people like former US President
Jimmy Carter had a remarkable response to ICI therapy. However, they do
not work in all patients; indeed over half of patients treated with
these agents die of their disease. New radiotracers are in development
to image the immune system in conjunction with a PET or SPECT camera.
Clinical trials with these tools have demonstrated the ability to
predict response to ICI therapy after just one cycle of therapy. Future
studies will aim to pre-select, with imaging, patients who are likely
to respond to immune checkpoint inhibitors thus enabling effective
therapy earlier and eliminating side effects of futile treatments. The
ability to select patients likely to respond to therapy will also save
billions in healthcare dollars.
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\5\ https://www.whatisbiotechnology.org/index.php/timeline/science/
immunotherapy/80.
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Data Science and Workforce
The field of nuclear medicine and molecular imaging is rapidly
expanding with new diagnostic imaging tracers, radiopharmaceutical
therapies (RPT), and technologies. With new diagnostic tracers comes a
need to properly interpret the innovative scans. Artificial
intelligence (AI) algorithms can assist with the tedious components of
image interpretation and even help with quality report generation.
Development of well-credentialed registries of studies to train and
validate such AI algorithms, reflecting diverse sets of patients will
help advance this field. Radiopharmaceuticals therapies (RPTs), like
other oncology therapies, are often studied in and approved for
patients with late-stage disease, for example, after all other
treatments have failed. To harness the full potential of RPTs, use
earlier in the disease course may be advisable. Image and clinical data
registries are needed to capture post-approval information on the use
of RPTs and the patient outcomes to further guide their use. Recent
imaging and therapy FDA approvals in prostate cancer and Alzheimer's
disease, two highly prevalent conditions, require that the highly
specialized field of nuclear medicine and molecular imaging train a
cadre of qualified individuals to diagnose and treat these patients. It
is critical for the NIH to fund and expand training grants so that our
brightest scientists have the skills to develop a sustainable career
pathway. Funding for AI technologies and registries will improve
patient care and outcomes.
summary and conclusion
Robust NIH funding is crucial to advancing our efforts to detect
and treat serious medical conditions. NIH investments help to sustain
both our local and national research institutions across every state in
the nation. China is advancing rapidly in the high technology medical
space notably in AI. Funding NIH's base program with at least $46.111
billion will help researchers, scientist and physicians retain its
competitive edge.
Thank you for your strong, continued support of NIH, NCI, NIMH,
NIBIB and all the Institutes and Centers working to advance molecular
imaging and radiopharmaceutical therapies to improve the lives of
patients worldwide. On behalf of the Society of Nuclear Medicine and
Molecular Imaging, I urge you to continue your strong support of our
nation's research and innovation enterprise.
[This statement was submitted by Richard L. Wahl, MD, President,
Society of
Nuclear Medicine and Molecular Imaging.]
______
Prepared Statement of the Student Support and
Academic Enrichment Program
Dear Chairwoman Murray, Ranking Member Blunt, Chairwoman DeLauro,
and Ranking Member Cole:
As you consider Fiscal Year 2022 appropriations for the U.S.
Departments of Labor, Health and Human Services, and Education, we
encourage you to help close opportunity and resource gaps in our
nation's public schools by funding the Student Support and Academic
Enrichment (SSAE) grant program authorized by Title IV-A of the Every
Student Succeeds Act (ESSA) at $2 billion, which represents a $780
million increase over FY2021.
Title IV-A is a flexible grant that supports state and district
efforts to: (1) support safe and healthy students by providing
comprehensive mental and behavioral health services, implementing
violence prevention programs, trauma informed care, school safety
trainings; and other evidenced based initiatives; (2) increase student
access to a well-rounded education, such as: STEM; computer science and
accelerated learning courses; career and technical education; physical
education; music; the arts; foreign languages; college and career
counseling; effective school library programs; and social and emotional
learning; and (3) provide students with access to technology and
digital learning materials and educators with professional development
and coaching opportunities necessary to effectively use those
resources.
Over the last four fiscal years, on a bipartisan basis, Congress
has provided a $4 billion investment for Title IV-A, which has allowed
districts to meaningfully invest in programs that provide direct
educational services and equitable supports to students. Its
flexibility has allowed districts to provide funding for critical
programs that support educators, school leaders, and students. As
district leaders continue to leverage the flexibility of the SSAE
grants, they are eager to plan for the continuance and/or expansion of
existing programs and services, and to create new programs.
To address unprecedented interruptions to learning caused by COVID-
19, we call on Congress now to go beyond what was authorized in ESSA by
providing $2 billion for the SSAE block grant. This will allow
additional school districts, especially in rural areas, to make
investments in not just one, but all three areas that this grant
supports. Right now--more than ever--districts need the continued
investments in the Title IV-A program.
The continued funding in these critical areas, especially during
these uncertain times, will give districts the opportunity to build on
the successes from the past 5 fiscal years as well as the ability to
use Title IV-A funds to address issues that the COVID-19 crisis has
made apparent and exacerbated. This pandemic has made clear that
districts face a wide range of unique challenges, whether it's ensuring
all children have access to technology for remote or blended learning
or the ability to provide mental health supports from afar. As school
systems prepare for the return to the classroom, they will need the
flexibility of Title IV-A funds to provide social and emotional
learning programs, engaging well-rounded classes like music and
physical education, and active learning opportunities enabled through
technology.
In order to support a safe and healthy school environment and make
sure our students receive a well-rounded education that puts them on a
path to success, we must continue to invest in our nation's schools,
educators, and most importantly, our students. For these reasons, we
urge Congress to fund the SSAE flexible grant program at $2 billion in
FY 2022.
Thank you for the consideration of this request, we are grateful
for the continued investments in the Student Support and Academic
Enrichment grant program under Title IV-A of the Every Student Success
Act (ESSA).
Sincerely.
______
Prepared Statement of Susan G. Komen Breast Cancer Foundation
Susan G. Komen (Komen) is the world's leading nonprofit breast
cancer organization representing the millions of Americans who have
been diagnosed with breast cancer and are currently living in the
United States. Komen has an unmatched, comprehensive 360-degree
approach to fighting this disease across all fronts--we advocate for
patients, drive research breakthroughs, improve access to high-quality
care, offer direct patient support and empower people with trustworthy
information. Komen is committed to supporting those affected by breast
cancer today, while tirelessly searching for tomorrow's cures. We
advocate on behalf of the estimated 284,200 women and men in the United
States that will be diagnosed with breast cancer and the more than
44,000 that will die from the disease in 2021 alone.
Screening tests are used to find breast cancer before it causes any
warning signs or symptoms. Regular screening enables us to detect
potential cancers at earlier stages and refer patients to further care,
often yielding better outcomes for patients and resulting in decreased
financial pressure on our healthcare system. Without access to early
detection programs, many individuals are forced to delay or forgo
screenings, which can lead to disease progression and later-stage
breast cancer diagnoses. To ensure access to early detection programs,
Komen is requesting that Congress fully fund the Centers for Disease
Control's (CDC) National Breast and Cervical Cancer Early Detection
Program (NBCCEDP) at the authorized amount of $275 million in Fiscal
Year (FY) 2022.
NBCCEDP was established with the passage of the Breast and Cervical
Cancer Mortality Prevention Act in 1990. The program plays a critical
role in helping low-income, uninsured, and underinsured women who do
not qualify for Medicaid receive timely breast and cervical cancer
screening, diagnostic and treatment services that are free or low-cost.
The covered services include clinical breast examinations, mammograms,
pelvic examinations, Pap tests, human papillomavirus (HPV) tests,
diagnostic tests if screening results are abnormal, and referrals to
treatment. Additionally, the NBCCEDP provides patient navigation
services to help women overcome barriers and get timely access to
quality care.
For 30 years, NBCCEDP has provided lifesaving breast cancer
screening and diagnostic services to eligible women in all 50 states,
the District of Columbia, six territories and 13 American Indian/Alaska
Native tribes or tribal organizations. NBCCEDP has served more than 5.8
million women since it launched in 1991, detecting over 72,000 breast
cancers, nearly 23,000 premalignant breast lesions, 4,900 cervical
cancers and 226,000 premalignant cervical lesions. More statistics on
the number of women served by the program in each state is available
here.
The program, which is a partnership between the CDC and state
health departments, also provides public education, outreach, care
coordination and quality assurance to increase breast cancer screening
rates and reach underserved, vulnerable populations. Each state program
operates within the national framework of legislation, policy, and
oversight; however, programs vary in funding, infrastructure,
populations served and geographical barriers. Programs can prioritize
the population they serve based on their cancer burden, environment,
available resources and goals. Unfortunately, these are often
influenced and limited by state funding and state legislative
constraints.
The COVID-19 pandemic highlighted the broad systemic trend that
exists with almost every public health crisis: consequences are more
commonly and more severely experienced in low-income, minority and
rural communities. Black women in the United States have a breast
cancer mortality rate about 40 percent higher than white women.
Similarly, Hispanic/Latina and American Indian/Alaska Native women are
30 percent more likely to be diagnosed with advanced stage breast
cancer compared with white women. NBCCEDP funding supports
interventions which help address inequities in breast cancer screening
and diagnosis since the program places special emphasis on women who
are geographically or culturally isolated and who identify as racial or
ethnic minorities. The program focuses on factors at the interpersonal,
organizational, community and policy levels that influence screening.
NBCCEDP invests in evidence-based interventions, for health care
systems and communities, which reflect cultural competencies needed to
reach communities that often distrust the medical system. Use of
multicomponent interventions of this type are found to be more
effective at connecting historically marginalized communities to
services. However, the CDC and state health departments need more
support.
More than 2.6 million women are eligible for NBCCEDP breast cancer
screening services. Authorized at $275 million, the program is
currently funded at approximately $197 million. Unfortunately, at
current funding levels NBCCEDP serves fewer than 15 percent of the
estimated number of eligible women for breast cancer screening services
and less than seven percent of eligible women for cervical cancer
screening.
An increase in funding in FY22 will be especially crucial as the
nation recovers from the COVID-19 pandemic. Data show that the pandemic
has caused people to delay life-saving breast cancer screenings.
Models, based on data from the 3-month period from early March 2020
through early June 2020, suggest there could be as many as 36,000
missed or delayed diagnoses of breast cancer because of COVID-19.\1\
This delay can mean women will not seek care until the cancer is more
advanced, leading to worse outcomes for the patient and much more
costly treatment. Furthermore, with many Americans experiencing job
loss and financial difficulties related to the COVID-19 pandemic, with
resulting loss of healthcare benefits, continued access to NBCCEDP is
needed now more than ever.
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\1\ IQVIA Institute for Human Data Science, Shifts in Healthcare
Demand, Delivery and Care During the COVID-19 Era (April 2020).
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The availability of the NBCCEDP impacts every taxpayer and people
in every congressional district, as the uninsured will eventually seek
care at our states' hospitals with late-stage disease, putting an even
greater strain on the patients, the health system and state budgets.
Ensuring adequate NBCCEDP funding is key to ensuring that low-income,
uninsured, and underinsured women across the country continue to have
access to vital screening services, health education and patient
navigation services, as well as enabling proper monitoring of state and
local breast cancer patterns and trends.
An increased investment in the NBCCEDP will allow the CDC and its
state and local partners to broaden its reach and pursue important
goals such as implementing innovative strategies and new methods to
find eligible women currently not using the program, including those
with no source of care, and lower incomes, education, and health
literacy levels, ultimately helping to create a more equitable health
care system.
The NBCCEDP has bipartisan support in both the Senate and House of
Representatives, with letters being submitted in both chambers in
support for full authorized funding for the program this year.
Increasing funding for NBCCEDP to the authorized level of $275 million
in the FY 22 Labor, HHS, Education Appropriations Bill will result in
more women being screened, more cancers being diagnosed at earlier
stages and ultimately better outcomes for women and lower costs for our
health care system.
[This statement was submitted by Molly Guthrie, Sr., Director,
Public Policy and Advocacy.]
______
Prepared Statement of the Task Force for Global Health
Thank you for this opportunity to provide testimony on polio
activities at The Task Force for Global Health. I write to express our
support for full funding for CDC's polio initiatives.
The Task Force for Global Health, founded nearly 40 years ago to
advance health equity, works with partners in more than 150 countries
to eliminate diseases, ensure access to vaccines and essential
medicines, and strengthen health systems to protect populations. Our
expertise includes polio, influenza, COVID-19, hepatitis, neglected
tropical diseases; vaccine safety, distribution and access; and health
systems strengthening. Our COVID-19 activities include working with 50
countries to deliver vaccines, address vaccine hesitancy, provide
vaccine safety guidelines; advise on digital contact tracing; train
epidemiologists in disease surveillance and response; distribute
essential protection and treatment to hard-hit communities; work
through existing health programs to ensure protection for vulnerable
groups, such as those afflicted with other diseases; and leverage our
existing supply chains to support ongoing response and assist countries
in delivering vaccines.
CDC has been engaged in the fight against polio for over 31 years.
Its leadership, in providing technical guidance and expertise in
countries, regionally and globally as part of the Global Polio
Eradication Initiative, has resulted in a reduction in the number of
worldwide polio cases from an estimated 350,000 in 1988 to 176 in
2019--a decline of more than 99% in reported cases. It has also
resulted in polio-free certification in five of the six regions of the
world--the African Region, the Americas, Europe, South East Asia and
the Western Pacific. Only two polio-endemic countries (nations that
have never interrupted the transmission of wild poliovirus) remain--
fghanistan and Pakistan. Without CDC's polio eradication efforts, more
than 18 million people who are currently healthy would have been
paralyzed by the virus.
At the Task Force for Global Health, we are providing surge
capacity expertise and technical assistance to outbreak countries and
those at high risk of future outbreak in the African region. Since
April 2018, the Global Polio Surge Capacity Team, consisting of a
project manager and four senior epidemiologists, have deployed a total
of 17 times to Ghana, Ethiopia, Indonesia, Congo-Brazzaville, and
Zambia, with a total of nearly 1,250 person days. In a time of growing
scale and scope of circulating type 2 vaccine-derived poliovirus
(cVDPV2) outbreaks, the team provides highly respected and valued
expertise across the Global Polio Eradication Initiative (GPEI)
partnership.
In Ministry of Health forums, the team is considered a crucial
component of polio outbreak response efforts, often working closely
with Emergency Operations Centers and national public health institute
staff. They have provided technical assistance for improving active
case search, enhancing surveillance efforts, and preparation and
implementation of vaccination campaigns. Supplementary immunization
activities have targeted hundreds of millions of children since the
team was created, and the long-term nature of their deployments has
provided essential continuity in settings that often see high staff
turnover.
Since CDC began the Frontline Polio Surge activities in October
2019, the team has provided supervision and direction to the deployed
staff, connecting them with district surveillance staff, WHO
colleagues, and Ministry of Health staff. They serve as in-country
experts and resources to teams deployed at district levels for
campaigns and surveillance strengthening activities. A training program
to prepare 100 NSTOP (National Stop Transmission of Polio) staff for
field deployments was developed and conducted.
In Ethiopia and Zambia, members of the team have taken the lead on
supporting the Ministries of Health in developing comprehensive
surveillance proposals for continued active case search of Acute
Flaccid Paralysis (AFP) cases, with SOPs and protocols for district
surveillance staff. These include the utilization of Field Epidemiology
Training Program (FETP) residents as sources of valuable local human
resource capacity. The institutionalization of this expertise is
crucial for these countries working towards controlling outbreaks and
ultimately eradicating polio.
Moving forward, we will continue to provide in-person technical
assistance to countries facing circulating vaccine-derived type 2
poliovirus outbreaks, to meet surveillance and response needs. This
work will include pre-, intra-, and post-vaccination campaign
activities. Additionally, the team will apply its extensive breadth of
experience in using data for action to strengthen surveillance
networks, country outbreak preparedness and response plans, and
training materials.
Lastly, we will provide remote technical assistance as needed on
campaign data quality, monitoring and evaluation of campaigns,
strengthening of EOCs, and supervision of local consultants. Members of
the team will continue to provide guidance on various long-term
requests from Ministries of Health and international agencies.
Due to Congress's support in FY 2019 and FY 2020, select CDC polio
accomplishments include:
--Provide instrumental support internationally and domestically
through extensive details to the CDC COVID-19 response and
through polio-supported staff to the COVID-19 pandemic response
in Afghanistan, Pakistan, and across Africa in the areas of
disease surveillance, health worker training, contact tracing,
risk communications and testing.
--Provide $56.13 million in FY 2020 to UNICEF for the expansion of
Community Based Vaccinator Program in Pakistan that now
includes over 24,000 workers (nearly 90% are women) who reach 4
million children annually, approximately 60 million doses of
oral polio vaccine, 2.9 million doses of inactivated polio
vaccine, and $3 million for operational costs for NIDs in all
polio-endemic countries and outbreak countries. Most of these
NIDs would not take place without the assurance of CDC's
support.
--Provide expertise in virology, diagnostics, and laboratory
procedures, including quality assurance, and genomic sequencing
of samples obtained worldwide; provide the largest volume of
operational (poliovirus isolation) and technologically
sophisticated (genetic sequencing of polio viruses) lab support
to the 145 laboratories of the global polio laboratory network.
CDC has the leading specialized polio reference lab in the
world.
--Deploy 210 Stop Transmission of Polio (STOP) members in 42
countries with two-thirds deployed to the African Region which
has significantly benefited from STOP support, contributing
substantially to the region's achievement of wild polio-free
status in 2020. CDC's Stop Transmission of Polio (STOP) program
trained and deployed 2100 public health professionals to
improve vaccine-preventable disease surveillance and to help
plan, implement, and evaluate vaccination campaigns.
--Use STOP participants to support local governments, health
facilities, and communities during the COVID-19 pandemic to
promote awareness of COVID-19 and provide contract tracing
while still supporting VPD surveillance, essential immunization
services, and polio eradication efforts.
Global polio initiatives are leading us to a day when polio will be
eradicated from our planet. The Task Force for Global Health is honored
to support CDC's leadership in its mission and to serve as part of this
strong global partnership to end polio in our lifetime.
With Congress' continued support, we will be able to support CDC's
outbreak priorities, which include strengthening surveillance for
polioviruses in all areas currently below certification standard and
rapidly responding to the detection in a population of the types of
polioviruses included in discontinued oral polio vaccines. We will also
ensure that populations are not exposed to the types of polioviruses
included in discontinued oral polio vaccines while laying the logistic
and epidemiologic groundwork for the complete cessation of use of all
oral polio vaccines.
Thank you for the opportunity to provide this testimony.
[This statement was submitted by Dr. Fabien Diomande, Director,
Polio Surge Program: Task Force for Global Health.]
______
Prepared Statement of the Task Force for Global Health
Thank you for allowing me to provide written remarks on behalf of
the Coalition for Global Hepatitis Elimination of the Task Force for
Global Health. I want to express the Coalition's strong support for
funding of at least $250 million for the Department of Health and Human
Services' national strategy for the elimination of viral hepatitis and
the global and domestic activities needed to achieve the plan's goals
for hepatitis elimination.
As the COVID-19 pandemic has taught us, we must eliminate deadly
viral threats when we have the opportunity. Now is the time to
eliminate hepatitis B virus (HBV) and hepatitis C virus (HCV).
The Task Force for Global Health, founded in 1984 to advance health
equity, works with partners in more than 150 countries to eliminate
diseases, ensure access to vaccines and essential medicines, and
strengthen health systems to protect populations. Our expertise
includes neglected tropical diseases and other infectious diseases;
vaccine safety, distribution and access; and health systems
strengthening.
The Coalition for Global Hepatitis Elimination, a program of the
Task Force for Global Health, with support of CDC and NIH, assists the
work of public health authorities, clinicians and community
organizations working on the front lines to prevent, detect and treat
HBV and HCV.
hbv and hcv infections are large global health problems
In 2015, a total of 296 million and 58 million persons worldwide
were living with HBV and HCV infections, respectively, which cause over
1 million deaths per year. In the United States, as many as 2.3 million
persons are living with HBV infection and 3.5 million persons are
living with HCV infection. The United States has the third largest
burden of HCV in the world, after only China and India. Of HBV and HCV
infected persons, if undiagnosed and untreated, 20%-25% will die of
liver disease or liver cancer. Three of four liver cancer deaths are
caused by HBV or HCV.
Hepatitis is a health disparity for racial/ethnic minority
populations and for rural America. The health threat of hepatitis B is
greatest for Asian Americans who were not vaccinated as children before
arriving in the United States. Hepatitis-infected persons in
communities of color have limited access to testing and lifesaving
treatment, leading to higher death rates for American-Indians/Alaskan
Natives and Black Americans. New infections of HCV are rising at an
alarmingly fast pace, fueled by the opioid crisis and increases in
injection drug use with unsafe equipment. HCV infections rates are
increasing the most among young adults in Appalachian states.
All of the public health and biomedical tools needed to address
these gaps in hepatitis prevention, testing, and treatment are
available. HBV vaccines have been in use for decades. Indeed, the 2020
Nobel Prize in Medicine was awarded to two American scientists for work
leading to the discovery of HCV and making possible the reliable tests
and first curative therapies for a chronic viral infection. Rarely in
public health do we have this opportunity. Now is the time to act
within our borders and globally to eliminate viral hepatitis.
Support for the Viral Hepatitis National Strategic Plan for the United
States: A Roadmap to Elimination 2021-2025
In January 2021, the Department of Health and Human Services
released the Viral Hepatitis National Strategic Plan for the United
States: A Roadmap to Elimination 2021-2025. The Plan is the first to
join with the global goals adopted by other nations and to aim for
elimination of viral hepatitis as a public health threat in the US.
With the support of this Committee and of Congress, the nation can act
on this first national elimination plan and strengthen efforts to stop
hepatitis in its tracks and ensure all people benefit from disease
elimination.
The Coalition activities supported by federal agencies, including
CDC and NIH, assist the implementation of the HHS strategic plan and
achievement of goals for hepatitis elimination. With federal partners,
the Coalition is focused on 4 key objectives for advancing hepatitis
elimination. The US must advance these priorities at home to ensure the
success of the national strategic plan and also provide global
leadership in addressing this public health threat.
Priority 1. Assure all newborns receive Hepatitis B vaccination and
are protected from HBV infection and liver cancer. A birth dose of
hepatitis B vaccine followed by two doses of infant immunizations
decreases risk of mother-to-child HBV transmission by 90%. However,
less than 50% of children globally receive hepatitis B vaccine within
24 hours, a critical intervention interrupting mother-to-child
transmission. Coverage is lowest (10%) in Africa where the prevalence
of HBV is the highest in the world. In collaboration with CDC, the
Coalition is training public health officials and assisting countries
to develop improved vaccination policies. Over 200 Ministry of Health
officials, research partners, and civil society members are
participating in training sessions to support more governments in
adopting hepatitis B newborn vaccine policies and improving coverage.
Through these efforts, the Coalition limits continued introduction of
HBV into the US and reduces HBV as a health disparity for Asian and
African-born Americans.
Priority 2. Implement simple models of care to detect and treat
persons living with HBV and HCV. The therapies for HBV and HCV are low
cost and safe. Therapies for HCV cure 95% of persons who receive
treatment. Most persons globally remain undiagnosed and untreated.
Proven models of care by non-specialists increase access to lifesaving
testing and treatment. in the US and globally. The Coalition assists
health systems simplify care and eliminate HBV and HCV as major causes
of death.
Priority 3. Develop tools for tracking progress in elimination.
Over the course of the next year, the Coalition will develop national
hepatitis elimination profiles for the United States and other high-
burden countries bringing together the latest data regarding hepatitis
burden and status of policy development with trends in access to
vaccination, testing and treatment. These profiles will help countries
identify gaps in hepatitis services and assist US Government agencies
to prioritize support.
Priority 4. Create additional opportunities to disseminate lessons
on effective hepatitis prevention care and treatment. Despite effective
tools and model programs, many countries like the United States are
facing a rise in new cases or low screening rates. Programs in the
United States and across the world benefit from sharing lessons
learned, saving time and avoiding redundant research. Over the past
year, the Coalition has reached over 1,000 individuals in 64 countries
through over 20 stakeholder meetings and web-based educational and
training sessions. These events are opportunities for programs to share
experiences and resources. The Coalition is collaborating with NIH to
publically share NIH-funded research advancing hepatitis elimination
and identify further research priorities.
Thank you again for this opportunity to support full funding of the
HHS roadmap for hepatitis elimination. The Coalition looks forward to
continued collaborations with HHS on the domestic and global activities
needed to eliminate viral hepatitis in the United States and globally.
[This statement was submitted by William P. Nichols, Executive Vice
President and Chief Operating Officer, Task Force for Global Health.]
______
Prepared Statement of the Task Force for Global Health, Inc.
Thank you for this opportunity to provide testimony on influenza
activities at The Task Force for Global Health. I write to express our
support for full funding for CDC's influenza initiatives.
The Task Force for Global Health, founded nearly 40 years ago to
advance health equity, works with partners in more than 150 countries
to eliminate diseases, ensure access to vaccines and essential
medicines, and strengthen health systems to protect populations. Our
expertise includes polio, influenza, COVID-19, hepatitis, neglected
tropical diseases; vaccine safety, distribution and access; and health
systems strengthening. Our COVID-19 activities include work with 53
countries to deliver vaccines, address vaccine hesitancy, provide
vaccine safety guidelines; advise on digital contact tracing; train
epidemiologists in disease surveillance and response; distribute
essential protection and treatment to hard-hit communities; work
through existing health programs to ensure protection for vulnerable
groups, such as those afflicted with other diseases; and leverage our
existing supply chains to support ongoing response and assist countries
in delivering vaccines. The Task Force's influenza program has provided
the framework for our work in COVID-19.
In 2013 with funding from CDC, the Task Force for Global Health
established the Partnership for Influenza Vaccine Introduction (PIVI)
to create sustainable, seasonal influenza vaccination programs in low-
and middle-income countries. The initiative protects communities from
the annual impact of flu, and also builds the adult immunization
infrastructure, capacity, and vaccine delivery systems critical for
future influenza pandemics and other infectious disease epidemics.
During the 2009 influenza pandemic, countries with seasonal
influenza vaccination programs were able to import, and use vaccines
much faster than countries without such programs.\1\ With financial and
technical support from CDC, PIVI supports countries in building legal,
programmatic, policy-making, and regulatory capacity to quickly import
and deploy influenza vaccines. The public-private collaboration
provides influenza vaccines allowing countries to annually exercise and
evaluate program effectiveness while moving towards country ownership
and sustainability. In support of this objective, PIVI funds and
fosters creation of regional collaborations that establish multi-
country region-level working groups to share data, programmatic
experience and explore opportunities for joint vaccine procurement
efforts.
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\1\ Porter, R. M. et al. (2020) 'Does having a seasonal influenza
program facilitate pandemic preparedness? An analysis of vaccine
deployment during the 2009 pandemic', Vaccine. Elsevier, 38(5), pp.
1152-1159.
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The influenza program infrastructure has supported, and continues
to support, the efforts to fight COVID-19. From disease risk education
and prevention, surveillance, the collection and analysis of laboratory
specimens, and the sharing of information and genetic sequence data--
the global and national influenza infrastructure is an indispensable
component of the public health response to COVID-19. The same influenza
vaccine delivery systems that enabled timely and efficient use of
seasonal influenza vaccine are, and will be, utilized to deploy COVID-
19 vaccine(s) as they become available. PIVI is at the forefront of
this work.
In 2020, building on the expertise, the experience, and the lessons
learned from the program, the Task Force quickly developed a new
program called CoVIP, a public-private partnership between CDC and the
Task Force engaging a global collaboration of public health technical
experts, to ensure that low and middle-income countries are ready and
able to deploy and evaluate COVID-19 vaccines as they become available.
With funding from the CARES Act, the Task Force's influenza program
is currently supporting 53 countries with technical assistance and some
funding to develop national deployment plans, evaluate programmatic
approaches, and refine their vaccine program approaches.
Applying the influenza program tools to the COVID-19 vaccine
rollout provides a unique opportunity to rapidly gather information to
improve and sustain the vaccines for global use, and establish long-
lasting national capacities for future use.
Thank you for the opportunity to provide this testimony.
[This statement was submitted by Dr. Mark McKinlay, Director,
Center for
Vaccine Equity: Task Force for Global Health, Inc.]
______
Prepared Statement of the Tourette Association of America
Dear Chairwoman Murray, Ranking Member Blunt and Members of the
Subcommittee:
The Tourette Association of America (TAA) would like to take this
opportunity to thank the members of the Subcommittee for the
opportunity to submit written testimony and for considering our request
for funding for Fiscal Year 2022 (FY22). The Centers for Disease
Control and Prevention (CDC) play a pivotal role in educating the
public. To that end, the Tourette Syndrome Public Health Education and
Research Program at the CDC is critically important to the TS and Tic
Disorder community. We respectfully request that you continue funding
the enacted level $2 million appropriation for the program in FY22
Labor, Health and Human Services (LHHS), Education and Related Agencies
Appropriations. The program on Tourette Syndrome is administered within
the National Center on Birth Defects and Developmental Disabilities
(NCBDDD) at the CDC, in partnership with the TAA. This program was
established by Congress in the Children's Health Act of 2000 (PL. 106-
310 Title 23) and is the only such program that receives federal
funding for Tourette Syndrome (TS) public health education. With your
support at the previously enacted level of $2 million, CDC can ensure
critically necessary progress continues in the areas of public
education, research and diagnosis for TS and Tic Disorders.
The TAA is the premier national non-profit organization working to
make life better for all people affected by TS and Tic Disorders. We
have served in this capacity for 49 years. Tics are involuntary,
repetitive movements and vocalizations. They are the defining feature
of a group of childhood-onset, neurodevelopmental conditions known
collectively as Tic Disorders and individually as Tourette Syndrome,
Chronic Tic Disorder (Motor or Vocal Type), and Provisional Tic
Disorder. People with TS and Tic Disorders often have substantial
healthcare costs across their lifespan for healthcare visits, special
educational services, medication, and psychological and behavioral
counseling. In a recent survey conducted by the TAA (2018 TAA Impact
Survey: https://tourette.org/research-medical/impact-survey/), 63% of
parents struggle to cover the high costs of services for their child
such as counseling, appointments and tutoring; 34% of parents report
they lost their job or they are not able to work as often due to the
increased caregiver duties of having a child living with TS; and, 18%
of parents are not able to afford medications and/or desired medical
care for their child. A recent Coronavirus impact survey, conducted by
TAA (https://tourette.org/coronavirus-and-tourette-syndrome/), found
that 82% of respondents said their tics or other symptoms worsened
during the pandemic.
The CDC Tourette Syndrome Website (https://www.cdc.gov/ncbddd/
tourette/data.html) on data and statistics states that data suggest
roughly 50% of children and teens with TS are not diagnosed. Studies
including children with both with diagnosed and undiagnosed TS have
estimated that 1 out of every 162 children (0.6%) have TS. However,
these numbers do not include children with Chronic or Provisional Tic
Disorders. The estimated combined total of all school-aged children
with TS or another related Tic Disorder is approximately 1-in-100.
Factoring in lifelong prevalence, we estimate 1 million adults and
children are living with Tourette Syndrome or another Tic Disorder in
the United States today. These statistics outline the need for
additional research on prevalence. Diagnosis is often complicated.
Among children diagnosed with TS, 83% have been diagnosed with at least
one additional mental, behavioral, or developmental condition according
to the CDC website. These co-occurring conditions include Attention
Deficit-Hyperactivity Disorder (ADHD), Obsessive Compulsive Disorder
(OCD), Autism, Oppositional Defiance Disorder, anxiety, depression,
learning difficulties among others and can significantly impact the
lives of those affected by TS. In fact, in TAA's 2018 Impact Survey,
42% of children felt that dealing co-occurring conditions was one of
the biggest challenges in managing TS. In addition, 32% of children and
51% of adults have considered suicide or participated in self-harming
behaviors. This underscores the need to increase the diagnosis rate so
physicians, teachers and parents can ensure that adequate support
services are in place. The CDC TS Program works to ensure primary care,
family doctors or pediatricians are equipped with the additional
knowledge necessary either to diagnose or to refer a patient for
optimal treatment.
Education professionals often do not receive detailed instruction
on how to assess and accommodate students who may have TS and Tic
Disorders. A study published in the Journal of Developmental &
Behavioral Pediatrics and written in partnership between the CDC and
the Tourette Association of America, ``Impact of Tourette Syndrome on
School Measures in a Nationally Representative Sample'', found children
with Tourette were more likely to have an individualized IEP, have a
parent contacted about school problems and have incomplete homework as
compared to children without Tourette or a Tic Disorder. Additionally,
most children with Tourette Syndrome had other mental, behavioral, or
emotional disorders or learning and language disorders. In TAA's 2018
Impact Survey, 83% of children felt that TS negatively impacted their
school experience and education and 69% of parents noted their child
having an individualized education plan (IEP) or 504 plan in place at
their school. Educators spend a significant amount of time with their
students providing more opportunities to assess symptoms and behavior
over a longer period of time. By increasing their knowledge base and
understanding of Tourette Syndrome, Tic Disorders and associated co-
morbidities, educators can refer students for medical assessment and
can also better serve the needs of this population whose challenges are
unique to the disorder. Educators can then begin to work more closely
with medical providers to develop effective, individualized education
plans.
TS and Tic Disorders are greatly misunderstood and often suffer
from misinformation and stigma. For example, coprolalia, the
involuntary utterance of obscene and socially unacceptable words and
phrases, is an extreme and rare symptom often sensationalized by the
media. Less than 10% of those diagnosed have this symptom, it is not
required for diagnosis, and does not persist in many cases. The CDC TS
Public Health, Education and Research Program provides important
information on symptoms/diagnostic criteria on their website and
through the outreach program educating the public and parents on
Tourette Syndrome and Tic Disorders to ensure a better understanding
which can lead to better diagnosis, earlier treatment and a better
understanding.
Delayed diagnosis or the lack of diagnosis can increase health care
costs, increase education costs and delay important treatment and
therapy for the patient. Comprehensive Behavior Intervention for Tics
(CBIT) is a non-medicated treatment consisting of three important
components: training the patient to be more aware of his or her tics
and the urge to tic; training patients to do competing behavior when
they feel the urge to tic; and, making changes to day-to-day activities
in ways that can be helpful in reducing tics. CBIT is now recognized as
a first line treatment by the American Academy of Neurology: https://
www.aan.com/Guidelines/Home/GuidelineDetail/958. The CDC Tourette
Syndrome Public Health, Education and Research Program strives to
increase the understanding and awareness among these critically
important medical and education professionals to increase the
percentage of school aged children with TS who are diagnosed, improve
the timeframe from symptoms to diagnosis and educate them about
treatment options like CBIT.
We appreciate the opportunity to submit testimony and appreciate
your thoughtful consideration of our request. TAA urges you to provide
continued funding for Fiscal Year 2022 for the Tourette Syndrome Public
Health Education and Research Program at CDC's National Center for
Birth Defects and Developmental Disabilities at the previously enacted
level of $2 million.
______
Prepared Statement of the Training Programs in Epidemiology and Public
Health Interventions Network
Thank you for this opportunity to provide written testimony on
behalf of the Training Programs in Epidemiology and Public Health
Interventions Network, known as TEPHINET, based at The Task Force for
Global Health.
The Task Force for Global Health, founded in 1984 to advance health
equity, works with partners in more than 150 countries to eliminate
diseases, ensure access to vaccines and essential medicines, and
strengthen health systems to protect populations. Our expertise
includes neglected tropical diseases and other infectious diseases;
vaccine safety, distribution and access; and health systems
strengthening. Our COVID-19 activities include: working with 50
countries to help vaccinate their populations, providing vaccine safety
guidelines; advising on digital contact tracing; training
epidemiologists on disease surveillance and response; distributing
essential protection and treatment to hard-hit communities; using
existing health programs to ensure protection for vulnerable groups,
such as those afflicted with other diseases; overcoming vaccine
hesitancy in the United States and leveraging our existing supply
chains for ongoing response and to help countries deliver vaccines.
As the Director of TEPHINET, one of the Task Force's 16 global
health programs, I am sharing my support for efforts to build the
global field epidemiology workforce needed to advance global health
security by detecting and responding to disease outbreaks before they
become pandemics with devastating human and economic consequences. I
would also like to share with you the incredible impact that U.S.
funding is already having on building a public health workforce of
field epidemiologists worldwide.
TEPHINET, is the global network of Field Epidemiology Training
Programs (FETPs) that is funded primarily through the Centers for
Disease Control and Prevention (CDC). You might be wondering what a
field epidemiologist does and why it is important to train more field
epidemiologists around the world. Think of it this way: when there is a
fire, we call upon trained and skilled firefighters to rush to the
scene of the fire and put it out as soon as possible. Not only are
field epidemiologists the firefighters of public health, but they set
up the fire alarm systems by developing disease surveillance systems to
catch cases early. When there is a disease outbreak, a natural
disaster, or a humanitarian crisis unfolding that threatens people's
health, field epidemiologists are deployed to the scene. Their task is
to understand how and why the health threat is occurring, who is
affected, and how to stop its spread at the source. For this reason,
field epidemiologists are known as ``Disease Detectives.'' They conduct
outbreak investigations, perform contact tracing, monitor travelers at
points of entry and attendees at mass gatherings, engage with
communities on disease prevention measures, and much more. They are
based at ministries of health, national public health institutes (like
our CDC) and are in many ways the lynchpin of the overall public health
system in a country.
TEPHINET consists of 75 Field Epidemiology Training Programs
training field epidemiologists in more than 100 countries. To date,
trainees and graduates of our member programs have investigated more
than 12,000 outbreaks or acute health events and developed more than
5,000 disease surveillance systems to improve case detection.
Worldwide, more than 19,000 FETP alumni have trained as the ``boots on
the ground'' to detect and respond to public health threats.
The need for greater public health capacity to prevent, detect, and
respond to public health threats and emerging infectious diseases is a
matter of life or death for people around the world. Such capacity
makes countries better able to sustain their own national systems,
leading to economic growth and reducing the likelihood of political or
economic instability.
Never has the need for increased field epidemiology capacity around
the globe been more apparent than now, as the world has grappled
socially and economically with COVID-19. The field epidemiologists in
our network have been working around the clock to trace contacts,
investigate and manage cases, analyze COVID-19 data, educate their
communities, and much more. Without them, the governments of most
countries, like my former home of South Africa, would not have access
to reliable data on the spread of COVID-19 in their populations. In
many countries, especially the poorest, there is simply no other
workforce in place to conduct contact tracing or case investigations.
Field Epidemiology Training Programs supported by TEPHINET fill that
gap and have been steadily expanding since their founding by the CDC
and other partners nearly 40 years ago.
FETPs have trained an estimated 19,000 ``Disease Detectives'' so
far, but the world needs more. COVID-19 and other emerging diseases are
not the only threats--FETPs fight every health threat known to us, from
well-known issues like Ebola, measles, and polio to lesser known but
deadly and debilitating diseases like Lassa fever and monkeypox. While
COVID-19 is clearly an emergent threat, there will always be a
``disease X'' that poses a grave threat to the health of Americans.
In Guinea, a resource-challenged country in West Africa, the FETP
housed within the Ministry of Health is providing critical support to
help control a recent Ebola outbreak. As of April 13, 2021, Guinea had
23 reported cases of Ebola. FETP trainees and graduates made vital
contributions to slowing the outbreak, particularly in the areas of
coordination and epidemiology surveillance. They led the development of
a surveillance system to detect Ebola cases, as well as the country's
Ebola response plan, contact tracing guides, and case definitions for
Ebola patients. FETP trainees and graduates consisted the leading
Ministry of Health workforce deployed in the field to conduct Ebola-
related surveillance. Thanks to the involvement of the FETP, the vast
majority (83%) of reports of suspected cases are being investigated.
Because of the Guinea FETP, established after the 2014-2016 Ebola
outbreak in West Africa had claimed thousands of lives, today Guinea is
seeing a dramatically different response compared to the 2014-2016
outbreak--including a significant increase in the known number of
contacts traced: 95% of contacts have been traced in the current
response.
Before coming to The Task Force, I was the director of the South
African Field Epidemiology Training Program (SAFETP), which was started
with CDC funding in partnership with the Ministry of Health and the
University of Pretoria, which conferred the Master of Public Health
degree to graduates. Over time, the program became owned by the
National Institute of Communicable Disease, but CDC Pretoria continued
to provide support in the form of a Resident Advisor, Scientific
Writer, and Statistician. There was an outbreak of diarrheal disease in
a small town in Free State province, and the FETP trainees or residents
identified the root cause to be poor maintenance at the water treatment
plant. Diarrheal disease from drinking unsafe water causes dehydration,
which is a killer of children under five. As a result of the
investigation done by the FETP residents, the town installed a new
water reticulation plant that ultimately benefited residents of the
town and improved their quality of life with fewer days of productivity
lost due to gastrointestinal illness.
Without enough ``Disease Detectives'' or boots on the ground to
detect and respond to public health emergencies, it will not be long
before another outbreak becomes a pandemic with severe human and
economic costs. There will be other outbreaks, and no single
institution has all the capacity required to be adequately prepared to
face future threats. We need to harness the resources and capacities of
a wide range of partners and stakeholders and we need political
leadership, whole-of-government and whole-of-society commitment. We
need to continue the United States' tradition of helping to build
sustainable public health systems across the world that ultimately
protect all people, including the American people.
In addition to supporting the development of Field Epidemiology
Training Programs, TEPHINET and The Task Force for Global Health have
been instrumental in developing the Global Field Epidemiology Roadmap,
a plan to advance field epidemiology training and capacity building
worldwide. As we speak, we at TEPHINET are coordinating a Strategic
Leadership Group of more than a dozen public health experts from around
the world to lead the implementation of this Roadmap, so that all
countries can develop the field epidemiology capacity needed to protect
and promote the health of their own populations and collaborate with
others to promote global health.
Thank you for your ongoing support of FETPs through the vital
funding you provide. Because of this support, more than 100 countries
now have a field epidemiology workforce that did not exist prior to the
establishment of their FETPs. However, we are still working to achieve
the International Health Regulations' target of having one trained
field epidemiologist per 200,000 population in every country. The good
news is that this goal is achievable with continued investment. A
global commitment to improving global health security by investing in
field epidemiology capacity building strengthens health systems by
training our world's ``Disease Detectives'' to respond to public health
emergencies, humanitarian crises and natural disasters, and in so
doing, saving money, saving resources, and saving lives.
[This statement was submitted by Dr. Carl Reddy, Director, Training
Programs in Epidemiology and Public Health Interventions Network.]
______
Prepared Statement of the Trauma Center Association of America
As you consider Labor Health and Human Services appropriations for
Fiscal Year FY (2022), the Trauma Center Association of America (TCAA)
asks the Committee to provide $11.5 million in funding for the Military
and Civilian Partnership for the Trauma Readiness Grant Program.
In 2016, the National Academies of Science, Engineering, and
Medicine (NASEM) released a report titled, ``A National Trauma Care
System: Integrating Military and Civilian Trauma Systems to Achieve
Zero Preventable Deaths After Injury.'' This report finds that one of
four military trauma deaths and one of five civilian trauma deaths
could be prevented if advances in trauma care reach all injured
patients. In the report, the National Academies recommended that the
United States adopt an overall aim for trauma care of ``zero
preventable deaths after injury,'' and sets forth elements of system
redesign that would provide military personnel with real-world training
and experience at civilian trauma centers. This training has the dual
benefit of maintaining military surgical battle readiness between wars
while at the same time improving civilian access to trauma care. The
report concludes that military and civilian integration is critical to
saving these lives both on the battlefield and at home, preserving the
hard-won lessons of war, and maintaining the nation's readiness and
homeland security.
Section 204, of S. 1379, the Pandemic and All-Hazards Preparedness
and Advancing Innovation Act of 2019 (PAHPAI), known as the MISSION
ZERO Act was signed into law June 24, 2019 (Public Law No: 116-22).
MISSION ZERO takes the recommendations of the NASEM report to create a
U.S. Department of Health and Human Services (HHS) grant program to
cover the administrative costs of embedding military trauma
professionals in civilian trauma centers. These partnerships will allow
military trauma care teams and providers to gain experience treating
critically injured patients and increase readiness for when these units
are deployed. Similarly, best practices from the battlefield are
brought home to further advance trauma care and provide greater
civilian access.
According to the Centers for Disease Control and Prevention trauma
is the leading cause of death for children and adults under age 44,
killing more Americans than AIDS and stroke combined.
Fully funding of MISSION ZERO will allow us to continue to save
lives, enhance trauma training for our military healthcare personnel
and help trauma centers manage and recover from mandatory furloughs of
surgeons, nurses and other staff that were a direct result of the COVID
19 pandemic.
We are grateful for your consideration of this important request.
Please do not hesitate to contact us directly if you have any questions
or need additional information regarding the MISSION ZERO Act.
______
Prepared Statement of the Treatment Action Group
Treatment Action Group (TAG) thanks the esteemed members of the
subcommittee for the opportunity to submit testimony regarding funding
for the U.S. Centers for Disease Control and Prevention (CDC) Division
of Tuberculosis Elimination (DTBE) for fiscal year 2022 (FY22)
appropriations. TAG is an independent, activist and community-based
research and policy think tank fighting for better treatment,
prevention, a vaccine, and a cure for HIV, tuberculosis (TB), and
hepatitis C virus (HCV). TAG works to ensure that all people with HIV,
TB, or HCV receive lifesaving treatment, care, and information. We are
science-based treatment activists working to expand and accelerate
vital research and effective community engagement with research and
policy institutions. Together with a broad coalition of stakeholders in
the TB advocacy community, TAG requests that the Subcommittee
appropriate $225 million to CDC DTBE for FY22, in particular to expand
critical TB research activities at the TB Trials Consortium (TBTC) and
mitigate the impact of the COVID-19 pandemic on struggling TB programs
across our country.
TAG works in close partnership with TB program practitioners and
researchers across the country to advance the collective goal of
eliminating TB through comprehensive, safe, and effective TB prevention
and treatment. TB cases continue to be reported in every state in the
United States (US) every year, with 8,916 cases reported in 2019.\1\ It
is estimated that approximately 13 million people in the US are
currently living with latent TB infection, which can progress to active
and contagious disease if left untreated.\2\ TB trends in the US are
also influenced by many of the same social determinants of health that
determine other health disparities--including poverty, lack of access
to healthcare, overcrowded housing and homelessness, and other
structural factors.\3\ This leaves many of the most vulnerable and
marginalized members of our society at greater risk of being exposed to
TB and developing active disease.
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\1\ U.S. Centers for Disease Control and Prevention. U.S. TB
Statistics. Division of TB Elimination. https://www.cdc.gov/tb/
statistics/default.htm.
\2\ Ibid.
\3\ Ibid.
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The state and local TB programs that are on the frontlines of
preventing and treating TB are engaged in critical work, and they rely
on the support of the CDC DTBE for guidance and funding. One important
way DTBE supports state and local TB programs is through its research
initiatives, including the TBTC. Housed within DTBE, the TBTC is a
unique partnership between CDC, health departments, academic research
institutions, and trial sites throughout the US and across the
globe.\4\ TBTC's research is mandated to be programmatically relevant
to health departments, meaning that investments in this research
network are some of the most cost-effective of any federal research
program. Tax payers' investments in the work of the TBTC have supported
dozens of studies of critical import to advancing the field and
improving TB treatment and prevention for people and communities
affected by TB at home and abroad.
---------------------------------------------------------------------------
\4\ U.S. Centers for Disease Control and Prevention. Tuberculosis
Trials Consortium. Division of TB Elimination. https://www.cdc.gov/tb/
topic/research/tbtc/default.htm.
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This research is sorely needed to advance more tolerable and
effective options for TB prevention and treatment. Current treatment
guidelines for drug-sensitive TB have been the same for almost four
decades, leaving programs and patients reliant on a regimen made up of
four drugs taken for 6-9 months requiring long periods of isolation and
management of difficult side effects necessitating intensive treatment
monitoring. However, promising results from a pivotal phase III trial,
TBTC's Study 31 demonstrated that a different combination of medicines
enables treatment for drug-sensitive TB to be shortened to just four
months without compromising any efficacy.\5\ This groundbreaking
finding has the potential to dramatically improve rates of treatment
completion, drive down TB transmission, and allow TB patients to return
to their loved ones and support themselves more quickly than ever
before.\6\ Study 31 and prior TBTC research at DTBE has had profound
global health security implications, where TB was the world's leading
cause of death to an infectious disease prior to COVID-19. Research at
CDC's TBTC has been the basis for public health treatment and
prevention guidelines developed by the World Health Organization (WHO)
that are critical for country TB programs where TB is particularly
endemic and claims 1.6 million lives a year.
---------------------------------------------------------------------------
\5\ Dorman SE, Nahid P, Kurbatova EV, Goldberg SV, Bozeman L,
Burman WJ, Chang KC, Chen M, Cotton M, Dooley KE, Engle M, Feng PJ,
Fletcher CV, Ha P, Heilig CM, Johnson JL, Lessem E, Metchock B, Miro
JM, Nhung NV, Pettit AC, Phillips PPJ, Podany AT, Purfield AE,
Robergeau K, Samaneka W, Scott NA, Sizemore E, Vernon A, Weiner M,
Swindells S, Chaisson RE; AIDS Clinical Trials Group and the
Tuberculosis Trials Consortium. High-dose rifapentine with or without
moxifloxacin for shortening treatment of pulmonary tuberculosis: Study
protocol for TBTC study 31/ACTG A5349 phase 3 clinical trial. Contemp
Clin Trials. 2020 Mar;90:105938. doi: 10.1016/j.cct.2020.105938. Epub
2020 Jan 22. PMID: 31981713; PMCID: PMC7307310. https://
pubmed.ncbi.nlm.nih.gov/31981713/.
\6\ Treatment Action Group. TAG Statement: Finally a New Four Month
Treatment for Drug Susceptible TB. 2020 October. https://
www.treatmentactiongroup.org/statement/finally-a-new-four-month-
treatment-for-drug-susceptible-tb/.
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While these results are certainly cause for celebration, much work
remains to be done to translate these findings into real public health
impact and ensure the availability of shorter treatment regimens to all
TB patients and programs. Many other areas of research are also still
on the horizon, including better TB prevention options and tools for
children and pregnant people. Some of this research is already underway
through other TBTC studies.\7\ The recent process by TBTC to solicit
research proposals (i.e. TBTC re-competition) sets up this heralded
research network for the next 10 years of programmatically-relevant
research that could include many of these pressing priorities for TB
R&D. But this progress is marred by decades of insufficient federal
funding for DTBE, which limits the ambition and scientific integrity of
how TBTC can approach its research agenda. In turn, the historical lack
of funding to DTBE limits the possibilities of implementation of such
research through state and local TB programs.
---------------------------------------------------------------------------
\7\ U.S. Centers for Disease Control and Prevention. Tuberculosis
Trials Consortium--Research Projects. Division of TB Elimination.
https://www.cdc.gov/tb/topic/research/tbtc/projects.htm.
---------------------------------------------------------------------------
Decades of stagnant appropriations for DTBE have led to the
Division currently being funded at nearly the same level as it was in
fiscal year 1994 (see right figure on impact of inflation). Factoring
in the rate of inflation over that period, that stagnant funding level
has drastically reduced the purchasing power of DTBE.\8\ In addition,
the costs of TB diagnosis and treatment have steadily risen, especially
for drug-resistant forms of TB which can now cost up to several hundred
thousand dollars to treat per person.\9\ As a direct result, DTBE has
been forced to do more with less, necessitating difficult decisions
about resource allocation to its lifesaving programmatic and research
initiatives. Without sufficient funding to bolster our nation's TB
programs, implementation of U.S.-led TB treatment strategies and
interventions made possible through publicly funded research at TBTC,
remains severely limited.
---------------------------------------------------------------------------
\8\ Treatment Action Group. The TB Research Engine That Could:
Sustaining the Success of the Tuberculosis Trials Consortium in
Turbulent Times. 2021 April. https://www.treatmentactiongroup.org/
publication/the-tb-research-engine-that-could/.
\9\ U.S. Centers for Disease Control and Prevention. CDC Fact
Sheet: The Costly Burden of Drug Resistant TB Disease in the U.S..
National Center for HIV, Hepatitis, STD, and Tuberculosis Prevention--
Newsroom. https://www.cdc.gov/nchhstp/newsroom/docs/factsheets/costly-
burden-dr-tb-508.pdf.
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The COVID-19 pandemic has worsened these capacity constraints.
According to a survey of TB program staff in the US, 87% of respondents
reported that they or their colleagues had been either partially or
completely reassigned to work on COVID-19.\10\ In many cases, these
reassignments were indefinite, and state and local TB programs continue
to operate under reduced capacity and temporary leadership. Many TB
clinics, hospitals, and other resources were also designated
exclusively for use in the COVID-19 pandemic response, as they were
uniquely outfitted for airborne isolation. The expertise of TB public
health clinicians, researchers and practitioners in particular, are
drawn upon in the COVID-19 response for their critical experience in
addressing an airborne infection.
---------------------------------------------------------------------------
\10\ Stop TB Partnership. The Impact of COVID-19 on the TB
Epidemic: A Community Perspective. Geneva: March 2021 https://
spark.adobe.com/page/xJ7pygvhrIAqW/.
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Some of the impacts of the pandemic are not yet visible. TB case
reporting dropped by 20% in 2020 compared to 2019. Unprecedented
barriers to accessing testing and care stemming from COVID-19 health
service disruptions and the reallocation of TB staff and resources from
conducting contact tracing, community outreach, and TB treatment
monitoring, to COVID-19 response efforts are likely the major causes of
this steep drop in TB notifications.\11\ The impacts of this reduced
capacity to prevent and respond to TB cannot be overstated, and the
costs of recovering from such impacts will be much higher than current
funding levels allow.
---------------------------------------------------------------------------
\11\ Deutsch-Feldman M, Pratt RH, Price SF, Tsang CA, Self JL.
Tuberculosis--United States, 2020. MMWR Morb Mortal Wkly Rep
2021;70:409-414. DOI: https://www.cdc.gov/mmwr/volumes/70/wr/
mm7012a1.htm?s_cid=mm7012a1_w.
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Stagnant funding, and the additional damage wrought by the COVID-19
pandemic, also threaten TB research and development efforts at DTBE. In
the aforementioned recent TBTC ``re-competition'' process for the next
10-year funding cycle, four of the prominent academic institutions that
housed some of the crucial leadership for TBTC's most promising studies
were excluded in the subsequent cycle due to shrinking research dollars
to expand this highly successful clinical trials network.\12\ The
collective TB expertise held within these institutions is
irreplaceable. Higher funding levels for DTBE and its research
initiatives, such as TBTC, are vital to retain the invaluable
experience necessary to complete study enrollment, data collection,
analysis, publication, and translation into policy. Furthermore,
expanded resources would position TBTC to embark on a new era of
clinical research led by these partners, building on its success
shortening treatment and prevention of TB and looking to future
opportunities, such as the possibility of TBTC trialing novel TB
vaccines. However, without an increase in funding, this experience will
be lost, taking with it the promise of TB research breakthroughs like
those shown in TBTC Study 31, which demonstrated the first effective
short course TB treatment in over 40 years.\13\
---------------------------------------------------------------------------
\12\ Treatment Action Group. The TB Research Engine That Could:
Sustaining the Success of the Tuberculosis Trials Consortium in
Turbulent Times.
\13\ U.S. Centers for Disease Control and Prevention. Landmark TB
Trial Identifies Shorter-Course Treatment Regimen. National Center for
HIV, Hepatitis, STDs, and Tuberculosis Prevention--Newsroom. 21 October
2020 https://www.cdc.gov/nchhstp/newsroom/2020/landmark-tb-trial-media-
statement.html.
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In order to avert further devastating impacts on TB programs,
prevention, care, and research, increased funding for CDC DTBE is
critically important. TAG requests that the subcommittee appropriate
$225 million--an increase of $90 million--to safeguard the lifesaving
progress that DTBE has made against TB in the US, sustain and grow the
government's vital TB research agenda at TBTC by retaining critical R&D
expertise, and to bring us closer to the elimination of TB once and for
all, here and abroad. We thank you for your support of public health
programs and research, and we look forward to working with you to
ensure the health of all those impacted by TB in the US and around the
world.
______
Prepared Statement of the Treatment Action Group
Treatment Action Group (TAG) thanks the esteemed members of the
subcommittee for the opportunity to submit testimony regarding funding
for the government's End the HIV Epidemic (EHE) at the U.S. Centers for
Disease Control (CDC) Division for HIV Prevention (DHAP) for fiscal
year 2022 (FY22) appropriations. TAG is an independent, activist, and
community-based research and policy think tank committed to racial,
gender, and LGBTQ+ equity; social justice; and liberation, fighting to
end HIV, tuberculosis (TB), and hepatitis C virus (HCV). We work
closely with community partners and stakeholders in the jurisdictions
funded by the federal government's EHE initiative towards an inclusive,
community-centered approach to end the HIV epidemic across our country.
TAG requests that the Subcommittee exceed the President's budget
proposal for the CDC EHE initiative of an $100 million increase in FY22
with an additional increase of $96 million to a total of $196 million
for DHAP ETE. In particular these resources would be critical to expand
EHE efforts, advance and expand vital community partnership activities,
and mitigate the impact of the COVID-19 pandemic among the hardest-hit
jurisdictions.
While there has been immense progress in the HIV epidemic with
rates declining from 37,500 new infections in 2015 to 34,800 infections
in 2019--much work remains on truly ending the epidemic in the hardest-
hit jurisdictions and populations in the U.S.\1\ HIV rates are not
evenly distributed across the nation and continue to be primarily
skewed towards the Southern states as the bulk of new diagnoses.\2\
Even more concerning, HIV disparities continue to severely persist
among the Black and Latinx communities. We see these troublesome trends
particularly among Black and Latinx gay and bisexual men, as well as
Black women. Black communities represent 13% of the U.S. population,
but make up 44% of new diagnoses.\3\ Similarly, Latinx communities
represent 18% of the U.S. population and account for 30% of new HIV
diagnoses.\4\ HIV comparably disparages Native American community,
people of trans experience, and people who use drugs with stark
disparities.
---------------------------------------------------------------------------
\1\ Health Resource and Services Administration. HIV Data and
Trends. HIV.gov. https://www.hiv.gov/hiv-basics/overview/data-and-
trends/statistics.
\2\ Ibid.
\3\ U.S. Centers for Disease Control and Prevention. Racial and
Ethnic HIV Rates--African Americans and Hispanic/Latinos. Division of
HIV/AIDS Prevention. https://www.cdc.gov/hiv/group/racialethnic/
africanamericans/index.html.
\4\ Ibid.
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It is of no surprise that social determinants of health deeply
impact these communities. These include housing, food security,
employment and economic justice, as well as undoing numerous policies
that violate the human rights of these communities and limit their
ability to seek treatment and care. Criminalization for example is
intertwined with the HIV epidemic, with many states continuing to have
arcane laws that do not align with science and only further stigmatize
communities of people living with, and vulnerable to HIV. Without
addressing the myriad of social, economic and legal needs of
communities impacted by HIV through a combination of targeted resources
and a human-rights policies, reaching the vision for ending the
epidemic across all communities will remain unclear and unattainable.
The previous administration ambitiously approached this challenge
of ending the HIV epidemic once and for all, by redoubling U.S. efforts
and formulating the landmark EHE initiative that would direct federal
resources towards 57 jurisdictions hardest-hit by HIV through CDC and
HRSA. While Congress, has responded in lockstep with bipartisan
increases to EHE since its inception, we believe that the COVID-19
pandemic has significantly impacted efforts at the community-level,
requiring a significant scale up in assistance to these jurisdictions.
Organizations and partners involved in the ACT NOW:END AIDS
coalition--of which TAG is a cofounder--report significant impact upon
services and outreach efforts to communities impacted by HIV. The lack
of swift and robust federal guidance on COVID-19 to HIV organizations
in the early stages of the pandemic led to many organizations having to
decide between either risking the safety of their staff by continuing
essential services, or temporarily closing programs. Additionally, many
already financially strained organizations struggled to obtain the
technologies necessary for telemedicine and many reported that
clients--especially low-income, and unstably housing individuals--could
not access these tools. Such delays led to clients missing care and
contributed to an overall sense of burnout among HIV professionals.
In addition to the direct impact upon services for PLHIV and
communities vulnerable to HIV, we have noted a significant shift in
human resources and public health personnel detailed to the COVID-19
pandemic. CDC HIV program staff are also contributing significantly to
the nation's COVID-19 response. The pandemic has caused severe
disruptions to care and treatment activities of the National Center for
HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP). According
to research from the Kaiser Family Foundation, nearly 700 CDC staff
(with 1,125 cumulative deployments) from NCHHSTP have been detailed and
deployed to the COVID response since the early days of the pandemic.\5\
This is primarily due to the Center staff's expertise in infectious
diseases. HIV public health practitioners from the CDC are drawn upon
for the COVID-19 pandemic, primarily for their expertise in centering
communities in prevention efforts and their ability to form key
relationships, conduct outreach, while grounding public health
prevention work in respect for human rights. However, scarce public
health resources and personnel corresponds to a shift away from EHE
efforts.
---------------------------------------------------------------------------
\5\ Dawson L, Kates J. Issue Brief: Key Questions on HIV and COVID-
19. Kaiser Family Foundation. 20 May 2021. https://www.kff.org/
coronavirus-covid-19/issue-brief/key-questions-hiv-and-covid-19/.
---------------------------------------------------------------------------
Furthermore, HIV community contributions to the COVID-19 response
have been significantly extended through HIV/AIDS research investments
at the National Institutes of Health (NIH) as well. For example, HIV
research first piloted the of use mRNA as a vaccine platform for HIV
prevention. These previous investments in HIV vaccine research boosted
the development of widely disseminated COVID-19 vaccines that
increasingly leveraged the well-developed research infrastructure of
HIV research.\6\
---------------------------------------------------------------------------
\6\ Chibbaro L. HIV Research Sped the Develop of the COVID-19
Vaccine. Washington Blade. 23 June 2021 https://
www.washingtonblade.com/2021/06/23/hiv-research-sped-development-of-
covid-vaccine/.
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In sum, the programmatic and research contributions of HIV have
been invaluable to the nation's COVID-19 response. But the shift in HIV
sector resources leaves EHE efforts in peril and limited in reaching
its ambitious goals for treatment and prevention of HIV. Due to the our
weakened public health infrastructure that COVID-19 leaves in its wake,
without significantly targeted and expanded resources, HIV disparities
will continue to be deeply entrenched in our nation's historically
disenfranchised and marginalized communities. We urge the subcommittee
to maximize resources to backfill the contributions of the HIV sector
and launch our HIV response with the same level of vigor that we saw
with the COVID-19.
To that end, we request an allocation of at least $196 million in
FY22 for CDC DHAP EHE Plan to begin to align the necessary resources to
mitigate the effects of COVID-19 upon struggling HIV programs and
shore-up the necessary HIV infrastructure. We applaud the
administration's and Congressional attention towards rooting out
systemic racism, and believe that these investments will go a long way
to begin addressing HIV as health disparity that primarily effects
communities of color.
Thank you for the members of the subcommittee for this opportunity
to submit testimony in support of CDC DHAP ETE initiative. We hope you
will take action and recommit to realizing the end of the HIV epidemic
with urgent, new resources.
______
Prepared Statement of Trust for America's Health
Trust for America's Health (TFAH) is pleased to submit this
testimony on the fiscal year (FY) 2022 Labor, Health and Human
Services, Education, and Related Agencies (LHHS) appropriations bill.
TFAH is a non-profit, non-partisan organization that promotes optimal
health for every person and community. Communities across the country
are overwhelmed with responding to the Coronavirus Disease 2019 (COVID-
19) pandemic with a depleted public health infrastructure and
workforce, while also responding to longstanding issues due to
increases in chronic diseases, substance misuse and suicide, health
disparities, and environmental health risks. TFAH's recent report, The
Impact of Chronic Underfunding on America's Public Health System, finds
that although health threats continue to increase, core public health
budgets at the federal and state levels remain stagnant.\1\ While
Congress has allocated billions of dollars to address COVID-19, this
funding is short-term and largely for use in response to the pandemic.
It follows a similar pattern since 9/11 of annually underfunding core
public health and then providing significant infusions of emergency
funding for a short time when a disaster hits. This is like building a
house on a shaky foundation. Without an investment in public health
year in and year out, problems cannot be prevented, or emergencies
reduced. While many thanks are due for your support during COVID, now
is the time to fix an underfunded system so we can ensure every
resident of the nation has the chance for optimal health and wellbeing.
Bold action is needed to strengthen and modernize public health. TFAH
urges Congress to fund the Centers for Disease Control and Prevention
(CDC) at $10 billion for the FY2022 budget, including investing in
these effective public health programs (unless otherwise noted, all
programs are in CDC):
---------------------------------------------------------------------------
\1\ The Impact of Chronic Underfunding of America's Public Health
System. Trust for America's Health 2021. https://www.tfah.org/report-
details/pandemic-proved-underinvesting-in-public-health-lives-
livelihoods-risk/.
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emergency preparedness
The COVID-19 response was weakened because the CDC's emergency
preparedness funding had been repeatedly cut, reducing essential
training and eliminating expert personnel. The CDC's Public Health
Emergency Preparedness (or PHEP) cooperative agreement has been reduced
by a quarter since FY2003 (48 percent when inflation is considered).
PHEP grants support 62 state, territorial, and local grantees to
develop core public health capabilities, including in areas of public
health laboratory testing, health surveillance and epidemiology,
community resilience, countermeasures and mitigation, incident
management, and information management. TFAH recommends at least $824
million for the PHEP (CDC), the level authorized in 2006.
The pandemic has also demonstrated the impact of failing to invest
in comprehensive readiness and surge capacity of the healthcare
delivery system. Funding for the Hospital Preparedness Program (HPP),
administered by the Assistant Secretary for Preparedness and Response,
has been cut in half since FY2003 (62 percent when inflation is
considered). HPP provides critical funding and technical assistance to
health care coalitions (HCCs) across the country to meet the disaster
healthcare needs of communities. There are 360 HCCs, comprised of
public health agencies, hospitals, emergency management and others,
that develop and implement healthcare and medical readiness plans;
response coordination; continuity of healthcare services delivery; and
medical surge. TFAH recommends at least $474 million for HPP (PHSSEF),
the level authorized in 2006.
environmental health
Not all federal emergencies are caused by infectious disease. Many
occur due to environmental factors. Here, too, core funding has been
insufficient. Since CDC's National Environmental Public Health Tracking
Network began in 2002, grantees have taken over 400 data-driven actions
to eliminate risks to the public. Data includes asthma, drinking water
quality, lead poisoning, flood vulnerability, and community design.
State and local health departments use this data to conduct targeted
interventions in communities with environmental health concerns.
Currently, 25 states and one city are funded to participate in the
Tracking Network. With a $1.44 return in health care savings for every
dollar invested, the Tracking Network is a cost-effective program that
examines and combats harmful environmental factors.\2\ Yet only half
the states receive funding. TFAH recommends at least $40 million for
National Environmental Public Health Tracking Network (CDC), which
would enable at least three additional states to join the network.
---------------------------------------------------------------------------
\2\ Return on Investment of Nationwide Health Tracking, Washington,
DC: Public Health Foundation, 2001.
---------------------------------------------------------------------------
obesity and chronic disease prevention
The COVID-19 pandemic has been exacerbated by preventable, chronic
health conditions, including obesity. In 2017-2018, 42.4 percent of
adults had obesity.\3\ Even though obesity accounts for nearly 21
percent of U.S. healthcare spending, funding for CDC's Division of
Nutrition, Physical Activity, and Obesity (DNPAO) is only equal to
about 31 cents per person.\4\ This Division funds state health
departments to protects the health of all Americans by promoting
healthy eating, active living, and obesity prevention in early care and
education facilities, hospitals, schools, and worksites and
neighborhoods; building capacity of state health departments and
national organizations to prevent obesity; and conducting research,
surveillance, and evaluation studies. However, DNPAO only has enough
money to implement its State Physical Activity and Nutrition Programs
(SPAN) in 16 states. TFAH recommends at least $125 million for DNPAO to
allow CDC to continue building its capacity and scaling its
interventions.
---------------------------------------------------------------------------
\3\ State of Obesity 2020. Trust for America's Health. Sept 2020.
https://www.tfah.org/report-details/state-of-obesity-2020/.
\4\ J. Cawley and C. Meyerhoefer, ``The Medical Care Costs of
Obesity: An Instrumental Variables Approach,'' Journal of Health
Economics 31, no. 1 (2012): 219-30, doi: 10.1016/
j.jhealeco.2011.10.003.
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Additionally, this year we once again saw the impact of inequities
in social and economic conditions facing people of color and tribal
nations. Among the programs at CDC that are effective in reducing
racial and ethnic health disparities are Racial and Ethnic Approaches
to Community Health (REACH) program and Good Health and Wellness in
Indian Country (GHWIC). CDC's REACH) program, within DNPAO, works in 31
communities across the country. It supports innovative, community-based
approaches to develop and implement evidence-based practices, empower
communities, and reduce racial and ethnic health disparities. As we are
seeing the effect that underlying health disparities are having on
COVID-19 patients, we urge renewed investment in programs such as REACH
that promote health equity. TFAH recommends at least $102.5 million for
REACH (CDC) to restore funds historically diverted from core REACH
programs. Within that total, TFAH recommends at least $27 million for
the Good Health and Wellness in Indian Country (GHWIC) program. Also
within DNPAO, GHWIC works with 21 tribes directly and funds 15 Urban
Indian Health Centers and 12 Tribal Epidemiology Centers (TECs). GHWIC
supports healthy behaviors in Native communities by supporting
coordinated and holistic approaches to chronic disease prevention,
continuing to support culturally appropriate, effective public health
approaches, and expanding the program's reach and impact by working
with more tribes and tribal organizations, including Urban Indian
Organizations. In addition, these GHWIC funds support the Tribal
Epidemiology Centers for Public Health Infrastructure (TECPHI).
Healthy Outcomes in Schools: Specialized efforts are needed within
certain age groups as well. CDC's Division of Adolescent and School
Health (DASH) provides evidence-based health promotion and disease
prevention education for less than $10 per student. Through school-
based surveillance, data collection, and skills development, DASH
collaborates with state and local education agencies to increase health
surveillance and services, promote protective factors, and reduce risky
behaviors. DASH programs reach approximately 2 million of the 26
million middle and high school students. TFAH recommends at least $100
million for DASH (CDC) to expand its work to 20 percent of all middle
and high school students.
Age-Friendly Public Health: The COVID-19 outbreak has shown that
collaboration between the public health and aging sectors is vital.
Every day 10,000 Americans turn 65 years of age, yet there have been
limited collaborations between the public health and aging sectors.
Public health interventions play a valuable role in optimizing the
health and well-being of older adults by prolonging their independence,
reducing their use of expensive health care services, coordinating
existing multi-sector efforts, and identifying gap areas, as well as
disseminating and implementing evidence-based policies. Yet as of now,
there is no comprehensive health promotion program for older adults. We
recommend the Committee provide CDC at least $50 million to administer
and evaluate an Age Friendly Public Health program to promote and
address the public health needs of older adults and collaborate with
partners in the aging sector.
Social Determinants of Health: Social determinants of health (SDOH)
such as housing, employment, food security, and education have a major
influence on individual and community health,\5\ as illustrated by
disparate outcomes and risk from COVID-19. Public health agencies are
uniquely situated to build these collaborations across sectors,
identify SDOH priorities in communities, and help identify strategies
that promote health. Currently most public health departments lack
funding and tools to support such cross-sector efforts and are limited
by disease-specific federal funding. TFAH thanks for the Committee for
$3 million in FY2021 to establish a new CDC SDOH program. We recommend
the Committee fund CDC to support local and state public health
agencies to convene across sectors, gather data, identify priorities,
establish plans, and take steps to address and improve community social
and economic conditions that promote health. Aligned with the
President's budget request, TFAH recommends at least $153 million to
further develop CDC's Social Determinants of Health Program and enable
grants to states and localities.\6\ More than 200 organizations have
endorsed this funding level.\7\
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\5\ Taylor, L et.al, ``Leveraging the Social Determinants of
Health: What Works?'' Yale Global Health Leadership Institute and the
Blue Cross and Blue Shield Foundation of Massachusetts, June 2015
\6\ The President's request for fiscal year (FY) 2022 discretionary
funding. (2021). Executive Office of the President. https://
www.whitehouse.gov/wp-content/uploads/2021/04/FY2022-Discretionary-
Request.pdf.
\7\ Letter to House Appropriations LHHS Subcommittee. April 26,
2021. https://www.tfah.org/wp-content/uploads/2021/04/
CDC_SDOHFunding_SignOn.pdf.
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suicide prevention
In 2019, suicide took 47,500 lives, and rates increased by 33
percent between 1999 and 2019.\8\ The complex nature of this issue
requires a comprehensive program that focuses on vulnerable
populations, data collection to inform efforts, and research on risk
factors. CDC's work helps identify and disseminate effective strategies
for preventing suicide, from strengthening access and delivery of
suicide care to promoting policies and programs that reduce the risk.
The programs consist of multisector partnerships, use of data to
identify vulnerable populations and risk and protective factors,
leveraging existing suicide programs and filling gaps through
complementary strategies and effective communications. TFAH recommends
at least $36 million to expand innovative prevention activities to an
estimated 25 sites from its current number of nine, and to support
state health departments as they develop and implement comprehensive
suicide prevention plans.
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\8\ Suicide Prevention, CDC. https://www.cdc.gov/suicide/.
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adverse childhood experiences
CDC estimates that if Adverse Childhood Experiences (ACEs) such as
abuse and neglect were prevented, there would be 21 million fewer cases
of depression, 1.9 million fewer cases of heart disease, and 2.5
million fewer cases of obesity.\9\ Preliminary evidence suggests the
pandemic is likely to increase children's exposure to ACEs due to
economic hardship, increased stresses on families, and reduced access
to school-based services and supports.\10\ CDC's approach to ACEs
prevention involves translating research into action and helping states
identify and implement effective prevention strategies. In 2020, four
state health departments were awarded funding to enhance or build
infrastructure for ACEs surveillance, implement strategies to prevent
ACEs, and leverage multisector partnerships to coordinate prevention
activities. TFAH recommends at least $7 million to expand innovative
ACEs prevention activities to four additional state health departments
and to build upon CDC's work on preventing early adversity in life and
mitigating the impact of ACEs on healthy child development.
---------------------------------------------------------------------------
\9\ BRFFS 2015-2017, 25 states, CDC Vital Signs, November 2019.
https://www.cdc.gov/vitalsigns/aces/index.html.
\10\ MMWR 2021, https://www.cdc.gov/mmwr/volumes/69/wr/
mm6949a1.htm.
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conclusion
The COVID-19 pandemic has underscored the dangers of the chronic
underfunding of public health. It has also exposed and exacerbated
longstanding disparities that have plagued our nation for far too long.
It is imperative that we not wait for the next emergency to fix this
problem. Instead, now is the time to invest in public health and fund
CDC at $10 billion in FY 2022, to become a more resilient and healthy
nation. Thank you for the opportunity to present this testimony to the
Committee.
[This statement was submitted by J. Nadine Gracia, MD, MSCE,
President & CEO, Trust for America's Health.]
______
Prepared Statement of United for Charitable Assistance
summary of fiscal year 2022 appropriations recommendations
_______________________________________________________________________
--Please continue to support and advance committee recommendations,
as well as related funding and policy initiatives, which
further encourage HHS and the Centers for Medicare and Medicaid
Services (CMS) to address arbitrary barriers that disrupt
patient access to essential charitable assistance in a
meaningful and timely way.
--Please work with your colleagues to encourage HHS to establish a
transparent and patient-centered regulatory system formally
governing charitable assistance programs that is consistent
with the current framework of OIG opinions and ensures all
policymakers and stakeholders have appropriate mechanism to
address challenges and opportunities in this space.
--Please provide meaningful funding increases for medical research
and public health progress to initiate further progress and
improve outcomes for the patient community.
_______________________________________________________________________
Chairwoman Murray, Ranking Member Blunt, and distinguished members
of the Subcommittee, thank you for your leadership on patient care, and
coverage and access issues. On behalf of United for Charitable
Assistance (UCA), we deeply appreciate the opportunity to provide a
critical, patient-centered perspective as you consider FY 2022
appropriations issues that impact healthcare coverage and patient
access. Most notably, we urge you to continue to advance committee
recommendations that feature and emphasize the need to quickly restore
access to critical charitable assistance programs that serve patients
with no other options. Moreover, please continue the investment in
medical research and public health activities. The COVID-19 pandemic
has hit the patient community hard and identified a litany of reasons
to enhance resources for medical research and public health while
addressing critical coverage and access challenges for those with the
greatest need (such as due to pandemic related job loss). Thank you
again for this important opportunity. Please consider UCA a resource on
moving forward.
about united for charitable assistance
We are a growing ad hoc group of patient community leaders that
seek to protect access to the charitable financial support programs,
which serve as a crucial part of the healthcare safety net for
individuals with rare, chronic, and life-threatening medical
conditions. We work together to educate policymakers so they understand
the value, impact, and vital nature of these programs and ultimately
support efforts to actively defend the lives and livelihoods of those
facing serious conditions that can now be better-managed through proper
care and innovative therapies.
about charitable assistance
Over recent years, CMS promulgated rules that effectively allow
private insurance companies to simply deny (or reserve the right to
deny at will) any premium or related healthcare payments made on behalf
of a patient. While these restrictions initially started in marketplace
plans, they have spread to Medigap plans, and various other forms of
coverage. The tangible result of these policies is that patients are
often denied access to mission-driven charitable support from non-
profits, civic groups, and houses of worship. Ultimately, these
restrictions form a back-door to pre-existing condition discrimination
where they are targeted at the most vulnerable populations and patients
lose their coverage due to an inability to utilize available support or
are simply steered towards one of the few remaining plans that has not
implemented restrictions (if they are available in their state).
Recently, the practice of copay accumulators has taken hold where some
assistance is accepted, but it is never applied to the patient's out-
of-pocket limits, thus rendering the support inconsequential for the
seriously ill. Finally, there is now an emerging practice for employer-
provided insurance known as the ``alternative funding model''. This
prescription drug procurement model improperly utilizes drug
manufacturers' free assistance programs to the detriment of patients
who are forced to continually switch drugs. Further, any costs
associated with filling the prescriptions or obtaining the medications
are not counted toward a patient's out-of-pocket insurance costs.
The situation is particularly dire for patients with rare, chronic,
and life-threatening illness that rely on innovative life-sustaining
medications and who occasionally turn to charities following a job loss
or similar hardship to ensure there is no catastrophic disruption in
access to care. Often times, when properly medicated, these patients
work and contribute to society, and they do not qualify for Medicaid or
similar need-based programs. Further, despite the severity of their
illness, the therapy or medical intervention likely blunts or slows the
progression of their disease meaning they also do not readily qualify
for disability programs. When assistance and access to proper care is
lost, a dangerous situation is created where the dramatic decline in
health rapidly outpaces the patient's ability to transition on to tax-
payer funded safety net programs.
We cannot overlook the fact that many patients in the
aforementioned situation also continue to turn to charitable assistance
during the process of transitioning on to federal programs as their
illness progresses. The disability waiting periods alone would be
insurmountable for many without charitable assistance. In this regard,
the need for charitable assistance is certainly not mitigated in
Medicare and related programs with some patients utilizing charitable
assistance to make ends meet and cover cost-sharing requirements.
contemporary examples of charitable assistance challenges
Ms. Lisa Wright is a patient advocate for the Fabry Disease
Community. Fabry disease is a rare genetic disorder that prevents the
body from making a certain enzyme called alpha-galactosidase A. The
symptoms of Fabry Disease are varied and progressive including kidney,
heart and neurological damage. There are several FDA approved
treatments for Fabry Disease. However, those treatments are very
expensive and as more and more costs are shifted to patients they need
access to financial assistance programs. Lisa is a wonderful example of
the importance of patient assistance. Lisa receives health insurance
premium and copayment assistance from a charitable assistance program.
This enables Lisa to remain working and volunteering for her community.
Patient assistance groups help Lisa and many other Fabry disease
patients obtain access to these expensive treatments and therapies
which mitigate the symptoms of the disorder and keep patients living
productive lives. Congress should work to ensure access to these
programs.
The situation of Dr. Jeffrey Swigert is an example of the new
Alternative Funding. Dr. Swigert is the father of two children with
Cystic Fibrosis. Cystic Fibrosis is a progressive, genetic disease that
causes persistent lung infections and limits the ability to breathe
over time. Dr. Swigert's employer is a self-insured plan that has
implemented a carve out for specialty treatments such as those for
cystic fibrosis. The employer will not cover treatments but instead
attempts to obtain them free of charge from manufacturer compassionate
treatment programs. However, the manufacturer programs are individual
with their own specific criteria. These programs are often time limited
and reserved for patients who are uninsured. Congress needs to review
this practice and potentially introduce legislation to modify.
recommendation
Please include committee recommendations, similar to the language
below, in the committee report accompanying the FY22 Senate L-HHS
Appropriations Bill. Please also work through the annual appropriations
process to facilitate a meaningful dialogue between the community and
HHS on challenges, opportunities, and potential solutions. Thank you
for your time and for your consideration of this request.
centers for medicare and medicaid services program management
Charitable Assistance and the Healthcare Safety Net.--The Committee
notes the important role that third-party charitable assistance plays
in regards to maintaining access to care and therapies, particularly
for patients impacted by life-threatening illness that have no other
options. The Committee notes the current significance of premium
assistance, co-pay assistance, travel assistance, and related programs
due to COVID-19 related economic challenges and loss of employment, and
their disproportionate role in ensuring access to care for those with
health disparities and from underserved communities. CMS is encouraged
to re-evaluate policies that facilitate pre-existing condition
discrimination for patients with serious illness by allowing covering
entities to reject or simply not apply assistance from independent
charities.
[This statement was submitted by James Romano, Executive Director,
United for Charitable Assistance.]
______
Prepared Statement of the United States Workforce Associations
Dear Chairman Murray and Ranking Member Blunt:
The undersigned organizations make up the United States Workforce
Association (USWA), a collaborative effort of local workforce boards,
businesses, educational institutions, and organizations involved in
workforce and economic development activities across the country. These
organizations are directly involved in the implementation of the
bipartisan Workforce Innovation and Opportunity Act (WIOA) of 2014,
specifically promoting the successful execution by local workforce
boards of the law to serve businesses, employers, and job--and career-
seekers. As our country grapples with unprecedented demand for
unemployment insurance and economic recession within the COVID-19
pandemic, the employer-led, local workforce development system
continues to respond with critical supports and services. Adequate
federal funding would ensure the system is poised to address these
community needs as we continue to recover from the devastating health
and economic effects of COVID-19.
As the Senate Appropriations Committee considers the Fiscal Year
2022 Labor-HHS Appropriations Bill, we urge you to support further
federal investment into WIOA and fully fund the law beyond its FY2020
authorized levels. Appropriated levels have fallen short of authorized
levels specifically in Title I accounts at the Department of Labor
(Adult Employment and Training Services, Youth Workforce Investment
Activities, and Dislocated Worker Employment and Training Services). An
expanded federal investment across WIOA programs leads to more job
training, education, skills development and innovative, proven
practices like industry-based sector partnerships, career pathways, and
apprenticeships. These strategies need to be implemented seamlessly to
respond to the effects of COVID-19. The established local workforce
system is well-positioned to enhance efforts for an equitable recovery;
low wage, low skill workers and minority populations were hit hardest
by COVID-19. The federal funding structure, which allows these funds to
be invested locally, provides for intentional investments to help those
most in need.
Local workforce development leaders are engaged directly with
businesses to help keep individuals employed and design training/
education programs to prepare the workforce for the future. We continue
to work with unemployed individuals to help them stay connected to the
workforce and evaluate other opportunities; recent BLS data suggests
nearly 41% of those unemployed have been unemployed for at least 27
weeks (long-term unemployed).\1\ Business services, especially for
small and medium-sized enterprises, have been critical during the
COVID-19 pandemic as employers sought to maintain payrolls and find
workers as businesses began to re-open. Increased federal
appropriations are greatly needed to address this unprecedented health,
economic, and social destabilization.
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\1\ https://www.bls.gov/charts/employment-situation/unemployed-27-
weeks-or-longer-as-a-percent-of-total-unemployed.htm.
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The Fiscal Year 2022 Labor, Health and Human Services, Education,
and Related Agencies Appropriations bill must fully fund all Titles I,
II, III, and IV at a minimum to the level authorized by the Workforce
Innovation and Opportunity Act (WIOA).
The funding levels we are requesting in the FY2022 Labor, HHS,
Education Appropriations Bill are listed below:
Title I--Department of Labor
--At least $899.987 million for Adult Employment and Training
Services,
--At least $963.837 million for Youth Workforce Investment
Activities, and
--At least $1.436 billion for Dislocated Worker Employment and
Training Services
Title II--Department of Education
--$678.640 million for Adult Education
Title III--Department of Labor
--$692,370,000 for Wagner-Peyser (FY2021 Enacted)
Title IV--Department of Education
--$3,675,021,000 for Vocational Rehabilitation Services (FY2021
Enacted)
This training, support and business partnership is vital to our
country's economic prosperity. For further information, please contact
Chris Andresen.
Sincerely,
______
Prepared Statement of the University of California San Francisco
School of Medicine
Committee Members,
I am writing in support of a FY 2022 budget request for Department
of Health and Human Services to develop a strategic plan and national
strategy to improve the diagnosis, treatment and prevention of herpes
simplex virus, types 1 and 2 (HSV). According to the Centers for
Disease Control and Prevention, over half of Americans have been
infected with HSV type 1 which can cause cold sores and genital ulcers,
and one in eight Americans are currently infected with HSV type 2,
which causes recurrent genital ulcers and is associated with
significant stigma. There are significant disparities by race and
sexual orientation, with HSV-2 impacting nearly half of all Black
women, and approximately one in three men who have sex with men, with
HSV being linked to HIV acquisition and transmission. Similar to HIV,
HSV can be transmitted from mother to child during birth, which causes
approximately 1,000 infant deaths annually. However, due to the poor
quality of currently available antibody tests, routine testing in
pregnancy or of the general population is not recommend by the United
States Preventive Services Task Force. Finally, there is a growing body
of evidence associating HSV to neurodegenerative diseases such as
Alzheimer's, highlighting the urgency to develop better prevention and
treatment strategies.
As a practicing clinician in the field of sexual health, I cannot
overstate the negative impact of herpes simplex virus on patients'
mental health. Countless studies have documented the mental health toll
of an HSV diagnosis on a patient's well-being, and though not usually a
fatal or serious infection itself, can lead to significant anxiety and
depression given the burden of living with a chronic infection which
must be disclosed to all future sex partners.
There is currently no national strategy to address HSV in the
current Federal STI Strategic Plan (2021-2025). There is no
surveillance for the condition, including its fatal outcomes among
neonates. The majority of disease spread is via asymptomatic carriers
unaware of their status. While antibody testing is readily available,
it is prone to false positive results and there is poor access to
confirmatory testing such as the Western Blot (previously used widely
for confirmation of positive HIV results, but not widely available for
herpes simplex virus). Given the implications for neonatal health, HIV
transmission, and potential impact on general population of sexually
active Americans, there is an urgent need for investment into the
development of more accurate diagnostic testing, prophylactic and
therapeutic vaccines, and antiviral medication that is more effective
at viral suppression.
In short, if we care about maternal-child health, the health of
communities of color, LGBTQ and other at-risk communities, and the
mental health of Americans, we must prioritize funding to address
herpes simplex virus infections.
Sincerely.
[This statement was submitted by Ina Park, MD, MS, Associate
Professor,
Departments of Family and Community Medicine & Obstetrics, Gynecology,
and
Reproductive Sciences, UCSF School of Medicine.]
______
Prepared Statement of the Washington State Association of
Head Start and ECEAP
Dear Chairman Murray, Ranking Member Blunt, and Members of the
Subcommittee,
On behalf of the Head Start community, thank you for this
opportunity to share the FY22 recommendation for Head Start funding.
I have the distinct pleasure of serving as the Executive Director
of the Washington State Association of Head Start and ECEAP (WSA)--a
statewide non-profit organization composed of representatives from Head
Start, Early Head Start, Migrant/Seasonal Head Start, Native American
Head Start and the Early Childhood Education and Assistance Program
(ECEAP, the statewide early childhood program). WSA represents 52 Head
Start programs from Bellingham to Walla Walla, including migrant and
seasonal and tribal programs. We are immensely proud of our efforts to
build early learners and support families facing financial hardships.
These past 16 months have been like none other. The COVID-19
pandemic has tested and challenged the nation's 1,600 Head Start
programs and required program managers and directors to adapt
overnight, think creatively, and juggle the complexities of supporting
children and families while also protecting them as well as staff and
meeting local, state, and federal guidelines. Last program year, little
did we know, social distancing, virtual learning, higher health and
sanitation standards, and workforce safety would emerge as daily issues
and priorities.
Thankfully, Congress and this Committee stood with us through this
turbulent season. Because of you, Head Start programs by and large were
able to return to services quickly, stay open, and support children
with in-person learning. When the first major outbreak overtook
Washington state, in-person services had to be re-thought and virtual
learning options made swiftly available. Quickly and competently,
programs responded to emerging family needs including delivering food,
learning materials, and cleaning supplies to doorsteps, holding Zoom
dance parties with preschoolers, and supporting the mental health needs
of parents and guardians. Several Head Start programs remained open
onsite during the entirety of the pandemic including the Denise Louie
Education Center in Seattle which provided childcare to many front line
and essential workers and parents that needed to be at work in person.
These heroic efforts undertaken by the Head Start community this
past year would not have been possible without COVID-19 relief funding
from Congress. Thank you.
As Head Start increasingly returns to regular programming and
doubles down on recruitment and enrollment, and the nation comes out
from underneath the cloud of COVID-19, the National Head Start
Association (NHSA) is seeking $12.1 billion in FY22. This level of
funding will help Head Start programs get back on track in three
distinct ways:
(1) by reassuring and bolstering the workforce ($247 million);
(2) by addressing growing and compounded childhood trauma through
staff training and additional counseling support ($363
million); and
(3) by extending program duration for programs and families
desperate for more hours of care and support ($730 million).
These are all long-standing priorities for NHSA and for programs
across the country--workforce investment, Quality Improvement Funding
for trauma-informed care, and extended duration--and we look forward to
working with Congress to meet these goals. Addressing these critical
needs is foundational to delivering the best results for children from
at-risk backgrounds.
Equally important to the quality of our programs and the health,
safety, and future success of Head Start is a long-overdue, often
overlooked issue: infrastructure.
Five years ago, the US Department of Health and Human Services
identified over $4.2 billion in Head Start capitalization needs, yet
Head Start's facilities needs have largely gone unaddressed. Local
programs are unable to afford critical health and safety updates, to
support access and compliance with the Americans with Disabilities Act,
to acquire licensable space in new neighborhoods, or to make modest
updates to align with what we know is best for early childhood
facilities. Head Start programs are serving children and families from
the most at-risk backgrounds-those below the poverty line and a
disproportionate share of children of color. In many cases, these
children are in buildings that are a half-century old, crumbling, and
out-of-date. Our Head Start programs, the children who spend most of
their days in these centers, and the communities that house these
facilities are in desperate need of long overdue investment.
In the state of Washington, our programs have persistently
underfunded facility construction and classroom upgrades. Washington
State Head Start programs are in desperate need of:
--HVAC systems and air filtration.
--Building repairs, including stairs and railings.
--Updated and/or new buses to ensure children can consistently get
back and forth to school.
--New classrooms to handle an influx of children who need in person
services; and
--Funds to build and construct new early learning facilities.
Please allow me to share specific examples from Head Start
providers in my state:
Tulalip Tribe Head Start currently serves 74 Early Head Start
children, 80 state funded preschool children, 112 child care spots, and
112 tribally funded kids. They need $1.6 million to add three
classrooms to their Head Start/Child Care wing. This expansion project
would address social distancing needs to meet licensing requirements
and the influx of children moving from remote to in-person learning
this fall as well as enable programing for another 30 children and
families.
This year has highlighted the need for outdoor play and learning
spaces. Family Services of Grant County in Moses Lake has active plans
to acquire neighboring property to create outdoor classroom space for
each preschool room. This expansion would add gardens and make critical
safety improvements. The cost of this project totals $1 million.
Moses Lake is also in immediate need for a larger transportation
and maintenance building, additional parking, and improved drop-off
vehicle access. The existing garage space is restrictive and lacks on-
site storage. Moses Lake would like to turn the current garage into
storage space, and build a new bus barn with more bays, so that the
current space could be used as a small mechanical repair shop and
perform preventative maintenance, reducing costs and extending the life
of existing buses. They estimate that the cost for this project is
about $1.7 million.
Finally, Okanogan County Child Development Association (OCCDA) in
Northeast Washington has struggled to find long-term, sustainable
educational space for five years and COVID-19 guidelines exacerbate
this concern. OCCDA previously partnered with the Tonasket School
District but after failed levy attempts, and the school district's own
struggles for space, the lease was terminated in 2017. This forced
OCCDA to relocate Tonasket Head Start and ECEAP programs to the
building that was used for Early Head Start and subsequently relocate
Early Head Start to a local church for a short period before landing at
a workable, but not ideal downtown location. These moves have squeezed
more children and staff into fewer and fewer square feet.
In 2018, OCCDA applied and was awarded and the Early Learning
Facilities Technical Assistance Grant to plan for a potential future
consolidated learning center; however, funds to purchase the property
and build the facility are still lacking. The estimated cost for
purchase and build at the time of our Feasibility Study was $1.5
million. For OCCDA, the pandemic has made a bad infrastructure concern
far worse. As a result, current facility size and availability limits
OCCDA's ability to conduct five-day per-week in-person classes to two
days a week in Tonasket.
These examples are replayed over and over again in the 52 Head
Start programs in the State of Washington. While there is a strong
desire to return to pre-COVID-19 conditions, for Head Start programs,
the road back is harder and longer. Candidly, we are not interested in
simply ``going back.'' We want to go forward. The pandemic has shone a
bright light on deferred maintenance and strained or inadequate
childcare facilities. Every Head Start program would welcome more
children, however, the present-day constraints in many ways prevent
expansion. Meaningful investments in our infrastructure--alongside
funding for our workforce, sustained support for mental health and
trauma response, and strengthening our existing program service hours--
are critical in FY22 to helping children and families make a strong
return.
In the days and weeks ahead, the Head Start community would
appreciate Congress's full embrace of the NHSA FY22 Recommendation of
$12.1 billion. The community also urges Congress to commit to an
examination of Head Start's infrastructure constraints and how the
federal government might partner with local programs to address these
urgent needs.
Thank you for your consideration.
[This statement was submitted by Joel Ryan, Executive Director,
Washington State Association of Head Start and ECEAP.]
______
Prepared Statement of the Women First Research Coalition
The Women First Research Coalition (WFRC) appreciates the
opportunity to provide this outside witness testimony to the Senate
Committee on Appropriations Subcommittee on Labor, Health and Human
Services, Education, and Related Agencies (Labor-HHS) for the Fiscal
Year (FY) 2022 LHHS appropriations bill. As you begin work on FY 2022
appropriations, we respectfully request that you provide $46.11 billion
for the National Institutes of Health (NIH) as well as additional
emergency funds to support the biomedical research enterprise recover
from the COVID-19 pandemic. We also request that you consider including
our report language on ``Diversity of the Biomedical Research
Workforce'' and the ``BIRCWH Fellows Program'' in the report that
accompanies the final FY 2022 Labor-HHS appropriations bill.
WFRC is a coalition comprised of the nation's leading professional
medical and research organizations specializing in women's health. Our
coalition was formed to address pressing challenges in women's health
research and to raise awareness among federal policymakers, Executive
Branch officials and the public about the need for sustained and
strengthened investment in women's health research, the prioritization
of research in conditions that are specific to women or those
conditions that may present differently in women than men, advance an
equitable and appropriate investment in women's health research that
improves the health outcomes of women, and ensure an adequate women's
research workforce.
funding for nih
Robust, sustained and predictable funding is important for all
biomedical research, particularly research on conditions that are
unique to or predominately occur in women. As Congress appropriates
funding for FY 2022, the WFRC is requesting that Congress provide
$46.11 billion, an increase of $3.1 billion, to the NIH, which would
allow for meaningful growth above inflation that would expand NIH's
capacity to support promising science in all disciplines. Any funding
increases should be allocated proportionately to all NIH institutes and
centers to ensure that meritorious research in women's health is
supported across the NIH. This would build on Congress' recent
investments in NIH that have allowed for advances in discoveries toward
promising therapies and diagnostics, supported current and new
scientists nationwide and advanced the potential of medical research.
It will also allow NIH to support meritorious research in women's
health.
As the country continues to address the COVID-19 pandemic, WFRC
also requests additional emergency supplemental funding for NIH to
address the costs associated with restarting biomedical research
including the increased costs of research related to personal
protective equipment, reagents, and existing drugs in the COVID-era as
well as ensure early stage and early established investigators remain
part of the biomedical research workforce. We are deeply appreciative
of the emergency funds Congress has already appropriated, but
additional emergency funding is needed to enable a full recovery from
the pandemic.
We urge Congress to designate a portion of these emergency funds
for the Eunice Kennedy Shriver National Institute for Child Health and
Human Development (NICHD), the National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK), and the National Institute on
Aging (NIA), three institutes that support significant amounts of
women's health research and have not yet received specific emergency
funding. It is clear that there are significant impacts on patients
with chronic conditions, as well as differences between how COVID-19
impacts women and men and the impact on older adults. We also must
study the effects that COVID-19 has on conditions that are unique to or
predominantly occur in women, such as pregnancy. Without additional
funding, NICHD, NIDDK, and NIA will not have the capacity to continue
adequately supporting existing research projects within their mission
while also undertaking new research on COVID-related complications and
comorbidities.
support diversity of the biomedical research workforce
Recent reports demonstrate that women in the workforce have been
disproportionately impacted during the COVID-19 pandemic. While women
comprise 47 percent of the US labor force, they accounted for 54
percent of initial COVID-related job losses and continue to make up 49
percent of losses.\1\ The recent May jobs report further emphasized
this point, with unemployment among women showing little
improvement.\2\ During the COVID-19 pandemic, women in academia are
balancing work with child care and virtual learning, financial issues,
and other issues at a disproportionate rate to men. OBGYNs have been
uniquely impacted during the pandemic since not only has their work not
slowed down during the pandemic, but has become more complicated. For
physician-researchers, there is little to no support currently in the
system that addresses their situation. This is exacerbated for women of
color, who are already underrepresented in obstetrics and gynecology.
We are concerned that the losses we have seen thus far represent just
the tip of the iceberg, and these inequities may result in loss of
women from the research workforce for many more years to come even as
the country continues to recover from the pandemic.
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\1\ https://www.wsj.com/articles/how-the-coronavirus-crisis-
threatens-to-set-back-womens-careers-
11601438460#::text=Women%20have%20already%20lost%20a%20disproportionate%
20number%20of%20jobs.&text=While%20women%20are%2047%25%20of,%2C%20accord
ing%20
to%20McKinsey%20%26%20Co.
\2\ https://www.bls.gov/news.release/empsit.nr0.htm.
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Therefore, the WFRC respectfully requests that you include the
following report language in the report that accompanies the FY 2022
LHHS appropriations bill under the NIH Office of the Director:
Diversity of the Biomedical Research Workforce.--The Committee is
concerned with the impact of COVID-19 on the diversity of the
biomedical research workforce, particularly women and women of
color early stage and midcareer investigators. The Committee
directs NIH to study the race and gender breakdown of the
impact of COVID on participation in the workforce by monitoring
the types of awards applied for and granted by gender and race
for two years. If the data demonstrate that less women are
applying for grants, then it is imperative that NIH take steps
to address this disparity. The Committee requests a status
update from NIH on this research in the FY 2023 Congressional
Justification as well as the steps being taken to maintain the
diversity of the research workforce.
support for the bircwh fellows program
Administered by the NIH Office of Research of Women's Health
(ORWH), the Building Interdisciplinary Research Careers in Women's
Health (BIRCWH) program is a mentored career-development program
designed to connect junior faculty, known as BIRCWH Scholars, to senior
faculty with shared interest in women's health and sex differences
research. There are currently 20 active BIRCWH programs across the
country--each one is a 2-year program, and costs approximately $170,000
per fellow per year. BIRCWH research areas include cardiovascular
disease, aging, cancer, neurosciences, musculoskeletal conditions,
autoimmunity, mental health, reproductive health, health disparities,
and infectious diseases/emerging infections & HIV/AIDS. Since its
creation in 2000, the BIRCWH program has trained over 700 fellows and
has an extremely strong track record of training successful women and
URiM Scholars and preparing them for independence.
Approximately 70 percent of BIRCWH fellows supported during 2000-
2018 received at least one successful R-level grant from the NIH and
many received private grants as well. To continue this important work,
more funding is necessary to support additional BIRCWH fellows at all
existing sites with a goal of increasing the diversity of the scholars,
sites, research areas supported by the program, and ultimately the
diversity of the biomedical research workforce.
Therefore, the WFRC respectfully requests that you include the
following report language in the report that accompanies the FY 2022
LHHS appropriations bill under the NIH Office of the Director:
BIRCWH Fellows Program.--The Committee allocates $3 million to
the ORWH's Building Interdisciplinary Research Careers in
Women's Health (BIRCWH) program to fund additional BIRCWH
fellows at all existing sites with a goal of increasing the
diversity of the scholars, sites, and research areas supported
by the program. These funds would support additional
researchers focused on women's health and sex differences,
which are priority research areas, as well as expand the
program's work in the reproductive sciences. The Committee
recognizes the effectiveness of the BIRCWH program, which is a
mentored career-development program designed to connect junior
faculty and senior faculty with shared interests.
conclusion
Thank you again for the opportunity to submit testimony to the
Committee as you begin your work on the FY 2022 appropriations bills.
We look forward to working with you to ensure that there is appropriate
funding for women's health research at the NIH, and to improve the
diversity of the biomedical workforce.
______
Prepared Statement of the Yale School of Public Health
To the Committee Members:
In my personal capacity, I am writing in support of a FY 2022
budget request for DHHS to develop a strategic plan and national
strategy for treatment and prevention of Herpes Simplex Virus (HSV)
Types 1 and 2. As you know, HSV is a chronic viral infection that
disproportionately affects women of color, LGBTQ populations, and
adolescents. HSV is well-known risk factor for HIV acquisition since it
disrupts and is a widely recognized driver of the HIV epidemic. As a
pediatrician, I wish to highlight the devastation that HSV causes
through neonatal herpes, often fatal to newborns or the cause of
overwhelming developmental abnormalities. Other neurodegenerative
diseases have been linked to HSV.
There is currently no centralized national strategy to address HSV,
it is not tracked or tested for, and the majority of spread is via
asymptomatic carriers unaware of their status. We can and should be
doing more to stop the spread and provide better treatment to the 1 in
3 Americans with this chronic condition.
I chaired a recent Committee for the National Academies of
Sciences, Engineering, and Medicine that produced a 2021 report for the
CDC entitled: Sexually Transmitted Infections: Advancing a Sexual
Health Paradigm. This report highlights the crisis of rising rates of
sexually transmitted infections in the United States. I hope that you
support the HSV Strategic Plan mandate for DHHS. Thank you.
Sincerely yours.
[This statement was submitted by Sten H. Vermund, Anna M.R. Lauder
Professor of Public Health, and Dean of the Yale School of Public
Health, and Professor in Pediatrics at the Yale School of Medicine.]
LIST OF WITNESSES, COMMUNICATIONS, AND PREPARED STATEMENTS
----------
Page
Academy:
for Radiology & Biomedical Imaging Research, Prepared
Statement of the........................................... 443
of Nutrition and Dietetics, Prepared Statement of the........ 445
Ad Hoc Group for Medical Research, Prepared Statement of the..... 447
AIDS:
Institute, Prepared Statement of The......................... 449
United, Prepared Statement of................................ 452
Alzheimer's:
Association and Alzheimer's Impact Movement, Prepared
Statement of the........................................... 455
Foundation of America, Prepared Statement of the............. 457
American Academy of:
Allergy, Asthma & Immunology, Prepared Statement of the...... 459
Pediatrics, Prepared Statement of the........................ 461
American Alliance of Museums, Prepared Statement of the.......... 463
American Association for:
Cancer Research, Prepared Statement of the................... 466
Clinical Chemistry, Prepared Statement of the................ 466
Dental Research, Prepared Statement of the................... 468
American Association of:
Colleges of Nursing, Prepared Statement of the............... 470
Colleges of Osteopathic Medicine, Prepared Statement of the.. 472
Immunologists, Prepared Statement of the..................... 473
Neuromuscular & Electrodiagnostic Medicine, Prepared
Statement of the........................................... 476
University Professors, Prepared Statement of the............. 478
American College of:
Cardiology, Prepared Statement of the........................ 479
Obstetricians and Gynecologists, Prepared Statement of the... 481
Physicians, Prepared Statement of the........................ 484
Surgeons, Prepared Statement of the.......................... 486
American Educational Research Association, Prepared Statement of
the............................................................ 487
American Foundation for Suicide Prevention, Prepared Statement of
the............................................................ 488
American Gastroenterological Association, Prepared Statement of
the............................................................ 491
American Geophysical Union, Prepared Statement of the............ 493
American Geriatrics Society, Prepared Statement of the........... 494
American Heart Association, Prepared Statement of the............ 496
American Indian Higher Education Consortium, Prepared Statement
of the......................................................... 498
American Liver Foundation, Prepared Statement of the............. 501
American Lung Association, Prepared Statement of the............. 503
American Massage Therapy Association, Prepared Statement of the.. 505
American National Red Cross and the United Nations Foundation,
Prepared Statement of the...................................... 507
American Nurses Association, Prepared Statement of the........... 509
American Psychological Association Services, Inc., Prepared
Statement of the............................................... 511
American Public Health Association, Prepared Statement of the.... 513
American Society for:
Engineering Education, Prepared Statement of the............. 515
Microbiology, Prepared Statement of the...................... 517
Nutrition, Prepared Statement of the......................... 519
American Society of:
Hematology, Prepared Statement of the........................ 521
Human Genetics, Prepared Statement of the.................... 522
Nephrology, Prepared Statement of the........................ 524
Nephrology, the American Society of Pediatric Nephrology, and
the National Kidney Foundation, Prepared Statement of the.. 740
Plant Biologists, Prepared Statement of the.................. 526
American Speech-Language-Hearing Association, Prepared Statement
of the......................................................... 528
American Thoracic Society , Prepared Statement of the............ 530
American Urogynecologic Society, Prepared Statement of the....... 532
America's Public Television Stations and the Public Broadcasting
Service, Prepared Statement of................................. 435
Anti-Defamation League, Prepared Statement of the................ 534
Association for:
Career and Technical Education and Advance CTE, Prepared
Statement of the........................................... 535
Clinical Oncology, Prepared Statement of the................. 540
Psychological Science, Prepared Statement of the............. 543
Research in Vision and Ophthalmology, Prepared Statement of
the........................................................ 545
Association of:
American Cancer Institutes, Prepared Statement of the........ 547
American Educators Fellows, Prepared Statement of the........ 549
American Medical Colleges, Prepared Statement of the......... 550
Farmworker Opportunity Programs, Prepared Statement of the... 552
Independent Research Institutes, Prepared Statement of the... 553
Minority Health Professions Schools, Prepared Statement of
the........................................................ 555
State and Territorial Health Officials, Prepared Statement of
the........................................................ 557
University Programs in Occupational Health and Safety,
Prepared Statement of the.................................. 559
Becerra, Hon. Xavier, Secretary, Office of the Secretary,
Department of Health and Human Services........................ 155
Prepared Statement of........................................ 163
Questions Submitted to....................................... 196
Summary Statement of......................................... 161
Bennett, Katherine, MD, FACP, Prepared Statement of.............. 561
Beyond AIDS Foundation, Prepared Statement of the................ 563
Bianchi, Diana W., M.D., Director, Eunice Kennedy Shriver
National Institute of Child Health and Human Development....... 69
Prepared Statement of........................................ 77
Questions Submitted to....................................... 136
Big Cities Health Coalition, Prepared Statement of the........... 564
Blunt, Senator Roy, U.S. Senator From Missouri:
Prepared Statements of ....................... 6, 74, 160, 252, 370
Questions Submitted by ..... 54, 124, 146, 150, 152, 217, 353, 420
Statements of ............................... 4, 72, 157, 250, 368
Braun, Senator Mike, U.S. Senator From Indiana, Questions
Submitted by................................................... 427
Campaign for Tobacco-Free Kids, Prepared Statement of the........ 567
Capito, Senator Shelley Moore, U.S. Senator From West Virginia,
Questions Submitted by ............................... 147, 151, 426
Cardona, Hon. Miguel, Secretary, Office of the Secretary,
Department of Education........................................ 247
Prepared Statement of........................................ 255
Questions Submitted to....................................... 282
Summary Statement of......................................... 253
Caregiver Action Network, Prepared Statement of the.............. 569
CDC Coalition, Prepared Statement of the......................... 571
Centers for Disease Control and Prevention, Prepared Statement of
the............................................................ 573
Christopher & Dana Reeve Foundation, Prepared Statement of the... 577
Coalition for:
Clinical and Translational Science, Prepared Statement of the 578
Health Funding, Prepared Statement of the.................... 581
Service Learning, Prepared Statement of the.................. 583
College on Problems of Drug Dependence, Prepared Statement of.... 586
Collins, Francis S., M.D., Ph.D., Director, National Institutes
of Health...................................................... 69
Prepared Statement of........................................ 77
Questions Submitted to....................................... 115
Summary Statement of......................................... 75
Congressional Fire Services Institute, Prepared Statement of the. 588
Consortium of Social Science Associations, Prepared Statement of
the............................................................ 588
Council of Academic Family Medicine, Prepared Statement of the... 590
Covenant House International, Prepared Statement of the.......... 592
Creutzfeldt-Jakob Disease Foundation, Prepared Statement of the.. 593
Crowley, Amanda Peel, Prepared Statement of...................... 595
Cure Alzheimer's Fund, Prepared Statement of the................. 597
Dave Purchase Project, the North American Syringe Exchange
Network, Tacoma Needle Exchange, and Coalition Partners,
Prepared Statement of.......................................... 599
Deadliest Cancers Coalition, Prepared Statement of the........... 601
Department of Preventive Medicine and Department of Medicine,
Infectious Diseases, Prepared Statement of the................. 603
Duke Health, Prepared Statement of............................... 603
Durbin, Senator Richard J., U.S. Senator From Illinois, Questions
Submitted by........................... 116, 133, 136, 143, 204, 297
Dystonia Medical Research Foundation, Prepared Statement of the.. 606
Education Finance Council, Prepared Statement of................. 608
Endocrine Society, Prepared Statement of the..................... 610
Entomological Society of America, Prepared Statement of the...... 612
Epilepsy Foundation, Prepared Statement of the................... 614
Evermore, Prepared Statement of.................................. 616
Evidence-Based Leadership Collaborative, Prepared Statement of
the............................................................ 619
Fauci, Anthony S., M.D., Director, National Institute of Allergy
and Infectious Diseases........................................ 69
Prepared Statement of........................................ 77
Questions Submitted to....................................... 133
Federal AIDS Policy Partnership's Research Work Group, Prepared
Statement of the............................................... 621
Federation of:
American Societies for Experimental Biology, Prepared
Statement of the........................................... 623
Associations in Behavioral and Brain Sciences, Prepared
Statement of the........................................... 625
Florida A&M University, Prepared Statement of.................... 627
Fred Hutchinson Cancer Research Center, Prepared Statement of
the ........................................................ 629, 631
Friedman, Harvey, MD, Prepared Statement of...................... 655
Friends of the:..................................................
Health Resources and Services Administration, Prepared
Statement of the........................................... 631
Institute of Education Sciences, Prepared Statement of the... 633
National Institute:......................................
of Child Health and Human Development, Prepared
Statement of the................................... 635
of Diabetes and Digestive and Kidney Diseases,
Prepared Statement of the.......................... 637
of Mental Health, Prepared Statement of the.......... 639
on Aging, Prepared Statement of the.................. 640
on Drug Abuse, Prepared Statement of the............. 641
FSHD Society, Prepared Statement of.............................. 643
GBS|DCIDP Foundation International, Prepared Statement of the.... 649
GEAR UP, Prepared Statement of................................... 651
Gibbons, Gary H., M.D., Director, National Heart, Lung, and Blood
Institute...................................................... 69
Prepared Statement of........................................ 77
Questions Submitted to....................................... 150
Global Health:
Council, Prepared Statement of............................... 652
Technologies Coalition, Prepared Statement of the............ 653
Health Professions and Nursing Education Coalition, Prepared
Statement of the............................................... 655
Hearing Industries Association and the Hearing Loss Association
of America, Prepared Statement of the.......................... 657
Hepatitis B Foundation, Prepared Statement of the................ 660
HIV Medicine Association, Prepared Statement of the.............. 662
HIV+Hepatitis Policy Institute, Prepared Statement of the........ 664
Human Factors and Ergonomics Society, Prepared Statement of the.. 666
Hyde-Smith, Senator Cindy, U.S. Senator From Mississippi,
Questions Submitted by................... 66, 129, 148, 152, 236, 358
I AM ALS, Prepared Statement of.................................. 668
Infectious Diseases Society of America, Prepared Statement of the 669
Integrative Health Policy Consortium, Prepared Statement of the.. 672
International Foundation for Gastrointestinal Disorders, Prepared
Statement of................................................... 675
Interstate Mining Compact Commission, Prepared Statement of the.. 676
Interstitial Cystitis Association, Prepared Statement of the..... 677
Kennedy, Senator John, U.S. Senator From Louisiana, Questions
Submitted by................................................... 236
Leahy, Senator Patrick, U.S. Senator From Vermont, Questions
Submitted by ................................... 129, 244, 363, 429
Learning and Education Academic Research Network, Prepared
Statement of the............................................... 679
Lymphatic Education & Research Network, Prepared Statement of the 681
Manchin, Senator Joe, III, U.S. Senator From West Virginia,
Questions Submitted by....................49, 121, 134, 215, 352, 415
March of Dimes, Prepared Statement of the........................ 683
Meals on Wheels America, Prepared Statement of................... 685
Medical Library Association and Association of Academic Health
Sciences Libraries, Prepared Statement of the.................. 688
METAvivor Research and Support, Inc., Prepared Statement of the.. 692
Michelson Center for Public Policy, Prepared Statement of the.... 694
Midwest Urban Strategies, Prepared Statement of the.............. 696
Moore Center for the Prevention of Child Sexual Abuse, Prepared
Statement of the............................................... 697
Moran, Senator Jerry, U.S. Senator From Kansas, Questions
Submitted by .................................................66, 234
Murray, Senator Patty, U.S. Senator From Washington:
Opening Statements of......................... 1, 69, 155, 247, 365
Questions Submitted by .............. 41, 115, 140, 196, 282, 394
NAF, Prepared Statement of....................................... 699
National Alliance:
for Caregiving, Prepared Statement of the.................... 700
for Eye and Vision Research , Prepared Statement of the...... 703
for Public Charter Schools, Prepared Statement of the........ 706
on Mental Illness, Prepared Statement of the................. 708
to End Sexual Violence, Prepared Statement of the............ 710
National Alopecia Areata Foundation, Prepared Statement of the... 712
National Association for State Community Services Programs,
Prepared Statement of the...................................... 714
National Association of:.........................................
Councils on Developmental Disabilities, Prepared Statement of
the........................................................ 717
Drug Court Professionals, Prepared Statement of the.......... 718
Emergency Medical Technicians, Prepared Statement of the..... 719
Nutrition and Aging Services Programs, Prepared Statement of
the........................................................ 720
Secondary School Principals, Prepared Statement of the....... 722
State Head Injury Administrators, Prepared Statement of the.. 725
State Long-Term Care Ombudsman Programs, Prepared Statement
of the..................................................... 726
National College Attainment Network, Prepared Statement of the... 729
National Council for Diversity in the Health Professions,
Prepared Statement of the...................................... 731
National Eczema Association, Prepared Statement of the........... 732
National Family Planning & Reproductive Health Association,
Prepared Statement of the...................................... 734
National Institutes of Health, Prepared Statement of the......... 736
National Kidney Foundation, Prepared Statement of the............ 738
National Marrow Donor Program/Be The Match, Prepared Statement of
the............................................................ 742
National Multiple Sclerosis Society, Prepared Statement of the... 744
National Pancreas Foundation, Prepared Statement of the.......... 746
National Public Radio, Prepared Statement of the................. 440
National Respite Coalition, Prepared Statement of the............ 749
National Technical Institute for the Deaf, Prepared Statement of
the............................................................ 752
National Viral Hepatitis Roundtable, Prepared Statement of the... 754
NephCure Kidney International, Prepared Statement of the......... 755
Neurofibromatosis Network, Prepared Statement of the............. 757
Northwest Portland Area Indian Health Board, Prepared Statement
of the......................................................... 758
Nursing Community Coalition, Prepared Statement of the........... 761
Nutrition & Medical Foods Coalition, Prepared Statement of the... 764
One Voice Against Cancer, Prepared Statement of.................. 766
Pandemic Action Network , Prepared Statement of the.............. 768
PATH, Prepared Statement of...................................... 770
Patient Services, Inc., Prepared Statement of.................... 772
Pediatric Policy Council, Prepared Statement of the.............. 774
Peel, Ann D., Prepared Statement of.............................. 776
Perez-Stable, Eliseo J., M.D., Director, National Institute on
Minority Health and Health Disparities......................... 69
Prepared Statement of........................................ 77
Questions Submitted to .................................. 136, 152
Personalized Medicine Coalition, Prepared Statement of the....... 778
Physical Activity Alliance, Prepared Statement of the............ 780
Planned Parenthood, Prepared Statement of........................ 782
Population Association of America/Association of Population
Centers, Prepared Statement of the............................. 785
Port Gamble S'Klallam Tribe, Prepared Statement of the........... 788
Public Health-Seattle & King County, WA, Prepared Statement of... 790
Pulmonary Hypertension Association, Prepared Statement of the.... 792
Reamer, Andrew, Prepared Statement of............................ 794
Reed, Senator Jack, U.S. Senator From Rhode Island, Questions
Submitted by...................................... 144, 209, 350, 415
Research!America, Prepared Statement of.......................... 795
Restless Legs Syndrome Foundation, Prepared Statement of the..... 796
Rotary International, Prepared Statement of...................... 798
Rubio, Senator Marco, U.S. Senator From Florida, Questions
Submitted by................................................... 243
Ryan White Medical Providers Coalition, Prepared Statement of the 801
Safer Foundation, Prepared Statement of.......................... 803
Scleroderma Foundation, Prepared Statement of the................ 806
Seattle Indian Health Board, Prepared Statement of the........... 808
Sleep Research Society and Project Sleep, Prepared Statement of
the............................................................ 810
Schatz, Senator Brian, U.S. Senator From Hawii, Questions
Submitted by
Schuchat, Anne, M.D., Principal Deputy Director, Centers for
Disease Control and Prevention, Prepared Statement of.......... 9
Shaheen, Senator Jeanne, U.S. Senator From New Hampshire,
Questions Submitted by ................................. 45, 137, 210
Sharpless, Norman E., M.D., Director, National Cancer Institute.. 69
Prepared Statement of........................................ 77
Questions Submitted to....................................... 140
Shelby, Senator Richard C., U.S. Senator From Alabama, Questions
Submitted by............................................ 62, 135, 231
Society for:
Maternal-Fetal Medicine, Prepared Statement of the........... 812
Neuroscience, Prepared Statement of the...................... 815
Women's Health Research, Prepared Statement of the........... 818
Society of:
Gynecologic Oncology, Prepared Statement of the.............. 820
Nuclear Medicine and Molecular Imaging, Prepared Statement of
the........................................................ 822
Student Support and Academic Enrichment Program, Prepared
Statement of the............................................... 825
Susan G. Komen Breast Cancer Foundation, Prepared Statement of... 828
Task Force for Global Health, Prepared Statement of the .......830, 832
Task Force for Global Health, Inc., Prepared Statement of the.... 833
Tourette Association of America, Prepared Statement of the....... 834
Training Programs in Epidemiology and Public Health Interventions
Network, Prepared Statement of the............................. 836
Trauma Center Association of America, Prepared Statement of the.. 838
Treatment Action Group, Prepared Statement of the ............ 838, 841
Tromberg, Bruce J., Ph.D., Director, National Institute of
Biomedical Imaging and Bioengineering.......................... 69
Prepared Statement of........................................ 77
Trust for America's Health, Prepared Statement of................ 842
United:
for Charitable Assistance, Prepared Statement of............. 846
States Workforce Associations, Prepared Statement of the..... 848
University of California San Francisco School of Medicine,
Prepared Statement of the...................................... 850
Walensky, Dr. Rochelle, Director, Centers for Disease Control and
Prevention..................................................... 7
Prepared Statement of........................................ 9
Questions Submitted to....................................... 41
Walsh, Hon. Martin J., Secretary, Office of the Secretary,
Department of Labor............................................ 365
Prepared Statement of............................................ 372
Summary Statement of......................................... 371
Questions Submitted to....................................... 394
Washington State Association of Head Start and ECEAP, Prepared
Statement of the............................................... 850
Women First Research Coalition, Prepared Statement of the........ 852
Yale School of Public Health, Prepared Statement of the.......... 855
SUBJECT INDEX
----------
AMERICA'S PUBLIC TELEVISION STATIONS AND THE PUBLIC BROADCASTING
SERVICE
Page
Corporation for Public Broadcasting.............................. 591
National Public Radio............................................ 440
DEPARTMENT OF EDUCATION
Office of the Secretary
Access to and use of Covid Relief Funds.......................... 263
Additional Committee Questions................................... 282
American Rescue Plan Act......................................... 255
Career Pathways.................................................. 354
Charter Schools .............................................. 278, 357
Closing Remarks.................................................. 259
Community-Based Programs......................................... 257
Department of Education Funding Levels........................... 256
Education:
as an Equalizer.............................................. 254
for Homeless Children and Youths............................. 249
Enforcement of Civil Rights Laws................................. 259
Expanding Free College Proposal to all Accredited Institutions... 262
Financial Literacy............................................... 282
Flexibility in Use of Covid Funding.............................. 276
For-Profit Colleges.............................................. 267
Free Community College........................................... 261
Program...................................................... 281
Fulfilling our Roles to Improve the Education System............. 254
Funding Inequities in State and Local Education Systems.......... 256
Higher Education................................................. 249
Homeless Education............................................... 279
Impact Aid....................................................... 265
Improving Career Pathways........................................ 258
Individuals With Disabilities:
Act.......................................................... 265
Education Act................................................ 248
In-person Instruction............................................ 271
Investment in:
Improving Students' Physical and Mental Health............... 257
Title I Grants to Local Educational Agencies................. 256
Investments to Support Higher Education.......................... 260
K-12 COVID-19 Funding/School Reopening........................... 355
Literacy......................................................... 275
Lost Learning Time and Disparities............................... 248
Mental Health.................................................... 358
NAEP Funding..................................................... 358
Overview of the Budget Request................................... 254
Postsecondary Education Investments.............................. 258
Rationale for Additional Funding................................. 269
Resource Allocation.............................................. 259
Return on Investment in Post-Secondary Education................. 273
School Infrastructure........................................ 259, 274
Secondary Education Alignment With Job Market.................... 274
Simplification of Free Application for Federal Student Aid....... 270
State Plans for Esser Funding.................................... 278
Student Aid Administration....................................... 259
Student Loan:
Pause........................................................ 355
Repayment.................................................... 264
Servicing............................................... 272, 353
Student Loans.................................................... 267
Support for Special Education.................................... 257
Teacher Training and Support..................................... 257
Title I Equity Grants............................................ 357
Title IX......................................................... 249
Transparency of Covid Relief Spending............................ 271
TRIO............................................................. 265
__________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Advances in Vaccine and Therapeutic Delivery Systems (RADx
Program)....................................................... 106
A.I. Detection of Cancers........................................ 110
Additional Committee Questions................................... 115
Alzheimer's Disease Research..................................... 101
ARPA-H:
and Cancer Research.......................................... 81
and Diabetes................................................. 86
Funding Level................................................ 81
Structure.................................................... 79
Autoimmune Research Breakthroughs................................ 93
Climate Change and Health........................................ 110
COVID-19:
and Health Disparities....................................... 107
and MIS-C.................................................... 109
Vaccine Booster Shots........................................ 87
CTSA Program ................................................. 95, 99
Cystic Fibrosis Research......................................... 94
Domestic Drug Supply Chain....................................... 95
Firearms Research................................................ 91
and Firearm Registries....................................... 103
Future of mRNA Technology........................................ 113
Gain-of-function Research in China............................... 88
Global Vaccine Distribution...................................... 85
Impact of COVID-19 Pandemic on:
Childhood Development........................................ 113
Research and Researchers..................................... 114
Infectious Disease Surveillance Efforts.......................... 97
Investigation into Origin of COVID-19........................... 90, 98
Long COVID....................................................... 84
Lupus Research................................................... 94
Marijuana Research............................................... 102
NCATS Rare Disease Research...................................... 100
Non-Opioid Alternatives to Chronic Pain.......................... 103
Origin of COVID-19........................................ 85, 104, 107
Pancreatic Cancer Research....................................... 95
Psychedelic Drug Therapies....................................... 101
RADx Partnerships................................................ 82
Rural Health Outcomes............................................ 96
Sexual Harassment at NIH......................................... 111
Social Determinants of Health.................................... 92
Structural Racism and Health Equity.............................. 80
Substance Use Disorder and Methamphetamine Research.............. 88
Suicide Prevention............................................... 83
Vaccine Development.............................................. 84
Office of the Secretary
340B............................................................. 184
ACA/Uninsured Number............................................. 194
Additional Committee Questions................................... 196
Adverse Childhood Experiences (ACEs) in Primary Care Settings
Demonstration Project.......................................... 206
Alternatives to Opioids for Treatment of Chronic Pain............ 179
Alzheimer's Disease.............................................. 181
BARDA Misused Funds.............................................. 217
Caring for all Americans Through Health and Human Services....... 165
Childcare........................................................ 194
Providers.................................................... 178
Collaborative Improvement and Innovation Network for School-Based
Health Services................................................ 206
Combating Mental Health and Substance Use Crises................. 167
COVID-19:
Boosters..................................................... 217
Vaccine Goals................................................ 192
Vaccines Donated Internationally............................. 217
Disease X........................................................ 218
Domestic Manufacturing........................................... 182
``Ending HIV'' Initiative........................................ 226
Excess Vaccines.................................................. 177
Fetal Tissue Research............................................ 187
Funding Core Program Operations.................................. 169
Graduate Medical Education....................................... 193
Health:
Disparities.................................................. 195
Insurance Subsidies.......................................... 178
Hyde Amendment .............................................. 189, 220
Influenza........................................................ 230
Investing in Children's Futures.................................. 167
Low Income Home Energy Assistance Program........................ 170
Maternal Mortality............................................... 190
Medicaid Reentry Act............................................. 175
Mental Health.................................................... 220
National:
Coordinating Committee on School Health and Safety........... 206
Suicide Prevention Lifeline.................................. 169
Native Hawaiian Health........................................... 174
Care Systems................................................. 214
Opioids....................................................... 183, 222
Organ Transplantation............................................ 219
Partial-Birth Abortions.......................................... 189
Personal Protective Equipment Manufacturers...................... 170
Preparing for and Responding to Public Health Crises............. 163
Promoting Biomedical Research.................................... 168
Provider Relief Fund (PRF)....................................... 221
Providing Oversight and Program Integrity........................ 169
Psychological Clinical Science Accreditation System.............. 221
Public Health Emergency Fund..................................... 174
Public Option.................................................... 188
Restoring America's Promise to Refugees.......................... 168
Short Term Plans................................................. 175
State Opioid Response Grants..................................... 177
Strategic National Stockpile..................................... 176
Supplemental and Reconciliation Funding.......................... 228
Technical Assistance--Health Centers Located in Hawaii........... 214
Telehealth.................................................... 173, 180
Unaccompanied Children .................................. 172, 185, 218
Emergency Intake Sites....................................... 191
__________
DEPARTMENT OF LABOR
Office of the Secretary
Adapting Training Programs to Meet Industry Needs................ 378
Addiction and Returning to Work.................................. 417
Additional Committee Questions................................... 393
Addressing the Workforce Shortage................................ 385
Alleviating Licensing Restrictions for Military Workers and their
Spouses........................................................ 390
American:
Jobs Plan.................................................... 373
Rescue Plan.................................................. 373
Apprenticeships and Nontraditional Industries.................... 420
Black Lung Benefits.............................................. 415
BLS Move......................................................... 408
Budget:
Increases.................................................... 381
Increases for Workforce Development Programs................. 388
Investments.................................................. 371
Cares Act and American Rescue Plan Spending...................... 424
Child Labor...................................................... 397
Combating:
Literacy Issues.............................................. 381
Wage Theft................................................... 389
COVID-19 Emergency Temporary Standard............................ 422
Creating A Well-Prepared Workforce............................... 377
Davis Bacon Enforcement.......................................... 396
Demand-Driven Training Programs.................................. 380
Department of Labor Surveys...................................... 383
Diversity in Apprenticeship Programs............................. 386
DOL Freedom of Information Act Requests.......................... 427
EBSA Consolidated Budget......................................... 410
Empowering America's Workers..................................... 367
Funding for:
the Appalachian and Delta Commissions........................ 391
West Virginia Grantees....................................... 426
Green Jobs....................................................... 421
H-2B VISAS....................................................... 384
ILAB Monitoring and Enforcement.................................. 396
Importance of the Job Corps Program.............................. 384
Increase in H-2B Visas........................................... 390
IT Solutions for Aging UI Systems................................ 387
Joint Employer Rule.............................................. 422
Learning Agendas and Evaluation Plan............................. 413
Miners And COVID-19 Protections.................................. 416
Modernizing Unemployment Insurance Systems....................... 367
Multilingual Worker Protection Staff............................. 402
OFCCP Enforcement................................................ 399
OSHA:
Enforcement Budget Increase.................................. 391
Enforcement in Large Business vs. Small Business............. 392
Farmworker Safety............................................ 401
Increases in Fiscal Year 2022 Budget......................... 376
Increases in the American Rescue Plan........................ 375
Partners Act Apprenticeship Legislation.......................... 386
Payroll Audit Independent Determination Program.................. 428
Protecting Workers and Their Wages............................... 366
Regional Apprenticeship Program.................................. 432
Research and Evaluation Funding.................................. 410
Restoration of DOL Staffing...................................... 424
Secretary's Calendar............................................. 428
Short-Term Compensation Program.................................. 379
Silica Dust Rule................................................. 416
Subminimum Wage.................................................. 404
Supporting America's Workers Through the Pandemic to Recovery, FY
2022 Budget.................................................... 374
Tax Increases for Infrastructure Bill............................ 382
Teleworking...................................................... 428
Training America's Workforce..................................... 367
Unemployment Insurance and:
Consumer Finance Applications................................ 426
Returning to Work............................................ 418
Third-Party Income Verification.............................. 429
Unemployment Insurance IT Modernization.......................... 429
Vision of the Fiscal Year 2022 President's Budget................ 365
WCF Unobligated Balances......................................... 411
WHD and OSHA FOIA Requests....................................... 409
Whistleblower Complaints and Staffing............................ 394
WIOA and Public Libraries........................................ 415
Workforce Shortages.............................................. 430
__________
REVIEW OF THE FISCAL YEAR 2022 BUDGET BLUEPRINT FOR THE CENTERS FOR
DISEASE CONTROL AND PREVENTION
317 Immunization Program......................................... 20
Additional Committee Questions................................... 41
American:
Medical Manufacturing........................................ 29
Rescue Plan Funds............................................ 65
Annual Appropriations............................................ 63
Cares Act Funds.................................................. 64
Changes to Mask Guidance and Reopening........................... 14
Child Mental Health.............................................. 18
Collaboration on Biodefense Facilities........................... 30
Community Health Workers......................................... 32
COVID:
in India..................................................... 26
Therapeutics................................................. 27
-19 Vaccines for Children and Adolescents.................... 35
Data Modernization............................................... 40
Earliest COVID Lessons........................................... 40
Funding Flexibility.............................................. 19
Gun Violence..................................................... 17
HIV in West Virginia............................................. 34
Infrastructure After Emergency................................... 13
International Collaboration...................................... 30
Lead Poisoning Prevention........................................ 21
Learning Lessons from COVID...................................... 31
Lessons Learned.................................................. 16
Mask:
Guidance..................................................... 21
Guidance for Vaccinated Individuals.......................... 25
Policy Jurisdiction.......................................... 35
in Workplaces................................................ 24
Opioids in:
New Hampshire................................................ 32
West Virginia................................................ 28
Pandemic Trajectory.............................................. 13
PFAS Contamination............................................... 33
Public Health Communication...................................... 24
Racial:
and Ethnic Disparities....................................... 36
Disparities.................................................. 15
Rural Health Disparities......................................... 18
Suicide Prevention............................................... 20
Vaccine:
Boosters..................................................... 38
Hesitancy.................................................... 37
in Pregnancy................................................. 38
Virus Origins.................................................... 23
Vulnerable Public Health System.................................. 27
[all]