[Senate Hearing 117-]
[From the U.S. Government Publishing Office]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2023
----------
WEDNESDAY, MAY 4, 2022
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:35 a.m., in room SD-138, Dirksen
Senate Office Building, Hon. Patty Murray (chairman) presiding.
Present: Senators Murray, Reed, Shaheen, Baldwin, Manchin,
Blunt, Moran, Hyde-Smith, and Braun.
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 please come to order. Today we are having
a hearing on the Biden Administration's fiscal year 2023 budget
request for the Department of Health and Human Services.
Senator Blunt and I will each have an opening statement, and
then I will introduce our witness, Secretary Becerra.
After his testimony, Senators will each have 5 minutes for
a round of questions. And while we were unable to have the
hearing fully open to the public or media for in-person
attendance, live video is available on our committee website.
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 glad to have you before our
committee today to provide answers to the questions the
American people have, especially this morning, given the
alarming reporting that the Supreme Court is planning to end
the Constitutional right to abortion in this country and
overturn Roe v. Wade.
If this is true, it will be devastating to many people
across the country. I have been warning about this for years
and I want you to know I am going to keep fighting back with
all I have to protect every woman's rights in this country. But
people across the country are worried.
They need to see leadership from the Biden Administration
on this. So I hope to hear more from you today about what the
Administration's plan is to respond to this and protect women's
health. Because make no mistake, women's lives are on the line.
Later this week, you will be hearing from my constituents
firsthand, coming out to Washington State. We will welcome you
there.
And Mr. Secretary, I want you to know, people are not just
worried about this attack on abortion, they are worried about
other challenges they are facing as well, because the past 2
years, to say nothing of the past 2 days, have put such a
strain on families and communities and our entire health care
system. People are depending on the Biden Administration for
support, for resources, and for real solutions, and I am
pushing to make sure that they get them.
After all of the hard won progress we have made in the
fight against COVID-19, families in my State and across the
country are depending on us to pass urgently needed emergency
COVID funding for tests, for treatments, and vaccines to
protect our communities across the country. But keeping up the
fight against COVID is just the start.
We have to learn from this pandemic and strengthen our
public health system to make sure we are better prepared with
more resources for CDC (Centers for Disease Control and
Prevention), like this budget proposes, with sustained annual
investments for local health departments, like my Public Health
Infrastructure Saves Lives Act would provide, and with steps
like my bipartisan Prevent Pandemics Act, because we know all
too well things like modern data systems, a robust public
health workforce, access to tests and vaccines, clearer
information, and more can make all the difference when it comes
to saving lives during a public health crisis.
But Secretary Becerra, the past few years have also shone a
harsh spotlight on the other healthcare challenges our
communities are facing, like the mental health crisis, which
the pandemic has made even more devastating, especially for our
kids. Over the last 2 years, we have seen a sharp rise in youth
mental health emergencies. I have heard from so many parents
back home whose kids are just not okay.
And over 200,000 kids have had their world shattered by the
heartbreaking loss of a parent or a caregiver. And we are
already stretched thin when it comes to providing communities
the support they need to address these crises. In Washington
State, our mental health workforce is only able to meet 17
percent of our State's needs. We have just got to do better.
This budget has crucial support for school based mental
healthcare and training, which can help reach students in need,
mental health support during early childhood, which is such an
important time for kids, community health centers which help
families across the country get connected to mental health
services, and increased resources for the 9-8-8 Suicide
Prevention and Crisis Lifeline.
I will be digging in here during questioning and during
your visit to Washington State later this week, because I want
to know how the Administration is doing and what it is doing to
address the mental health crisis. Secretary Becerra, I also
want to hear more from you about how the Administration is
working to address our Nation's substance use disorder crisis,
which has gotten so much worse during this pandemic and has
grown even more deadly due to fentanyl.
I hear about the tragic consequences of this crisis every
single day. Overdose deaths in Washington State have increased
by two-thirds since 2019. And nationally, we recently passed
the tragic milestone of over 100,000 overdose deaths in 1 year.
Our communities are doing what they can. But, Mr. Secretary, we
desperately need reinforcements.
The significant increase in this budget for prevention,
treatment, and recovery efforts is absolutely necessary. But it
is going to take more to get this done. And that is why I am
working with my Senate colleagues on bipartisan legislation.
But I want to hear more from you about your plan to address
this crisis.
When it comes to women's health, I was relieved to see this
budget does include significant resources for the Title X
Family Planning Program, which helps get women birth control
they need to plan a family on their own terms, lifesaving
breast and pelvic exams that detect cancer early, and more.
Mr. Secretary, I have fought hard to protect the Title X
Program, and I heard from Washington State patients and
providers recently about what this program means in their
lives. They told me firsthand how it makes all the difference
to people with the tightest budgets who might not have access
to this basic lifesaving healthcare without Title X.
It is unthinkable to me anyone would not support this
program. But as we are being reminded every day, Mr. Secretary,
reproductive healthcare is under attack at every angle, and we
need to be doing everything we can to protect it. So I want to
hear more from you today about what we can do to continue
strengthening this program and do everything we can to support
other programs that protect women's health.
That is why I was so pleased to see this budget also
increases resources to help lower our Nation's unacceptably
high maternal mortality rate. And like so many other issues, we
know our maternal death rate has been particularly devastating
for black and Native American women, which is why the
investments in this budget to advance equity and reduce health
disparities are vital, especially the significant proposed
increase to CDC's work in this space.
This budget also calls for additional support in the fight
against HIV, AIDS to increase access to lifesaving treatment,
reduce new cases, and continue our progress towards ending this
epidemic in our country. Finally, I want to make crystal clear
how important it is that we invest in childcare and early
education programs and bring down those costs for parents.
This pandemic has made clear to everyone what I have been
saying for years, quality, affordable childcare is not
optional. It is essential for parents, for kids, for our
businesses, for our economy, for everyone. When it comes down
to it, parents not being able to work because they cannot find
childcare is never just a problem for them, it is one more
position a small business can't fill, and it is one less link
in our supply chain moving things along.
That is why I believe this has to be a top priority to help
parents get back to work and to lower costs. That is such a
massive strain on parents' budgets right now. Mr. Secretary, I
know this budget includes a boost in childcare resources. I was
glad to see that.
But I need to be clear, right now millions of families
across the country are struggling to find or afford childcare,
providers are struggling to keep their doors open, and
childcare workers cannot make ends meet and are leaving their
jobs to find better pay.
So we have got to go bigger to solve this problem here, and
which is why I have been fighting so hard to make a truly
historic investment in childcare that would bring down costs
for families, bring up wages for workers, and all fully paid
for simply by asking those at the top to pay their fair share.
I am going to keep pushing to make sure we get that done
through reconciliation, because at the end of the day, as happy
as I am to see these boosts for childcare in this budget, which
I have fought for a long time as well, it is clear to me we
can't just tinker at the edges here, we need bold solutions.
And that is why I will keep pushing to deliver on that,
just as I am pushing for more progress in all the issues that
we will be talking about today. I always like to say that a
budget is a statement of values, and I am pleased to see this
budget does make it crystal clear that the Administration's
values are in the right place. But families back home need us
to do more than just state our values, they need us to live up
to them.
They need us to act on them with steps that take stress off
their shoulders, put money back in their pockets and actually
solve the problems they are facing. So I look forward to
working with you and President Biden to make sure that happens.
Thank you again for being here. With that, I will turn it over
to Senator Blunt.
statement of senator roy blunt
Senator Blunt. Thank you, Chair Murray. Secretary Becerra,
certainly appreciate you being here today. We served together
in the House, but I think in the last year we have had a chance
for our relationship to grow and I am grateful that that has
happened. I am grateful that we have--I think you have made a
better effort than we have seen sometimes in the past to get
information to us as quickly as you could.
And as you and I have talked about, sometimes we just need
to know the direction you are headed in a quick way and find
out all of the granular detail when you can get to it. But I am
appreciative that I think that is headed on a better path. I
think both Chair Murray and I are eager to try to get a bill
completed this year.
You are much better off if you have money to spend in next
year's spending cycle, October 1, or even December 1 than if it
is April 1 or March 1 or May 1, and I hope we can work together
to continue to move this process forward. I do think that the
completion of the process last year was late enough that some
of the gains we made in the final appropriations bill aren't
reflected in the budget that was submitted by the President,
and I look forward to a chance to talk to you more about that.
You know, at last year's hearing, my opening statement
focused almost totally on the pandemic. At that point, we were
a year in. The Trump Administration had provided the country
with several FDA (Food and Drug Administration) authorized
vaccines, tests, and treatments for COVID-19, while starting a
campaign to vaccinate the most high risk Americans. And of
course, the Biden Administration continued that vaccine
campaign.
Where we were last year was pretty significant in terms of
the vaccines that were available and what we had done,
considering the fact that a year earlier we had never heard of
COVID-19, and we were making real progress. The Biden
Administration came into the White House with lots of COVID
promises on how it would get it under control and do so by
following the science.
Unfortunately, I have some concerns that the Administration
has really abandoned the approach of following the science when
it became clear over the last year and a half that Federal
vaccine mandates, school closure guidance, mask requirements on
public transportation have, I think, overreached the moment and
overreached the science. Most recently, politics appear to have
colored some of the COVID decisions the Department has made.
The CDC announced the termination of the Title 42 order
last month. They announced it would occur at a specific date in
the future, but they announced it at a time when we were still
trying to deal in the Congress and with your Department of the
ongoing challenges of COVID. You know, COVID can't be a
challenge one place and not a problem, in my view, at another
place.
Congress has been provided few details on the impact of the
decision of what would happen if Title 42 goes away at the
border. Yet no plans to see what we do with an influx of
illegal individuals into the country, or in your Department,
what happens with the unaccompanied children that come under
your responsibility. I don't see the money in this budget
reflecting every news story I see about how those numbers
intend to grow.
Further, CDC's decision to vastly increase the number of
people coming into the country who are unvaccinated that was
made after CDC said what they considered the current--this is
their quote, ``current public health conditions and increased
availability of tools to fight COVID-19 allowed the border to
be looked at in a different way.'' Just days later, the
Department made contradictory decisions to extend our own
country's public health emergency.
Emergency here, not a problem there really doesn't make
much sense to many people and even people in the Congress who
can be persuaded that things that don't make sense somehow do
make sense. Just yesterday, the CDC updated guidance that two
and a half years into the pandemic, it is now everyone--
recommending everyone get tested before domestic travel.
It seems to me that it is so out of focus with every other
discussion that is going on, and hopefully we will have a
chance to talk about that today also. I think these decisions
just aren't consistent and intellectually create lots of
problems. How do you expect Americans to follow your
recommendations when you say it is safe to open the borders to
unvaccinated immigrants, but not safe enough to remove mask on
planes, and not safe enough to have even domestic travel
without a test?
Meanwhile, even as the borders reopen as if the pandemic is
over, Americans remain under Federal vaccine and mask mandates.
And the Department is asking Congress to provide additional
funding for therapeutics, for tests, for vaccines. And I want
to make it very clear, I am actually for that funding. You and
I have talked about it. I have worked hard to try to come up
with a package that would provide the money we need.
Those accounts, on my view, need to be restored. We are not
out of the woods yet with COVID-19, and we need to be prepared
for a future wave that very easily could happen. We need to
think about what needs to happen with vaccinating the under-
five population, and to ensure that any American who needs a
therapeutic can get one. Unfortunately, the Administration made
two poor decisions that make this additional funding nearly
impossible.
First, it pushed through a $1.9 trillion COVID-19 funding
bill that provided less than 6 percent of COVID and less than 1
percent of funding toward vaccines and therapeutics, and only 5
percent toward COVID public health.
Simply put, the Administration had the opportunity to
purchase more vaccines, more tests, more treatments, and to
continue more research into additional therapeutics, and to
prepare for a disease that we will likely be facing for the
next several years, and in that huge package that went into the
economy, not very much of it was dedicated to the purpose of
the COVID-19 fight.
Secondly, we were actively negotiating a bill last month to
provide the Department with $10 billion to purchase those
additional therapeutics, vaccines, and tests. And right at the
end of that negotiation, before the Congress could vote on the
bill, again CDC announced that COVID is not a problem at the
border.
Finally, Mr. Secretary, as it did in last year's bill,
COVID-19, has overshadowed the budget request, and I think
assuming that we will just continue to do all of the COVID
spending as emergency spending. There are a lot of new plans in
this budget that the Congress just rejected in the omnibus
bill.
And frankly, if we have a bill this year, and I hope we do,
I think we have to look at what this Congress was willing to
agree to after months of negotiation and use that as the
blueprint. It doesn't mean the blueprint can't be adjusted, but
assuming we are going to see dramatic changes like the removal
of the long standing Hyde Amendment.
You know, every person on this committee who has ever voted
for a final Labor, HHS (Health and Human Services) bill has
voted for Hyde since it first appeared in 1976. And the bills
you and I voted for in the House, if we voted for the Labor,
HHS bill, all had that amendment in them.
Mr. Secretary, the committee been successful over the last
several years of passing bipartisan bills because we have not
made fundamental, drastic funding changes.
I was concerned when I saw the money for ARPA-H (Advanced
Research Projects Agency for Health), which I also support, but
there was $4 billion of new money in the budget for ARPA-H and
no money for the traditional research at NIH (National
Institutes of Health), which of course is exactly what people
who have been concerned about ARPA-H--have been concerned
about, whether it was at NIH or somewhere else, does ARPA-H
begin to slow down the momentum of the overall research that we
need to continue to see in NIH?
I hope we can set aside our partisan difficulties, as we
did last year in this committee, and support programs like
maternal mortality programs that benefit all Americans.
The mental health programs. I will say that I was very
heartened with the mental health program increases and had some
concerns about some structural changes in the mental health
agency of SAMHSA (Substance Abuse and Mental Health Services
Administration) that you are responsible for.
But we will get back to that and talk about that later. And
again, while this will be a challenging hearing, as these
always are, welcome and I have appreciated our chance to begin
to work together with this new responsibility that you have
taken in the last year and look forward to the time to ask
questions today.
[The statement follows:]
Prepared Statement of Senator Roy Blunt
Thank you, Chair Murray. I appreciate Secretary Becerra being here
today to discuss the Administration's fiscal year 2023 budget request.
At last year's hearing, my opening statement focused on the
pandemic. At that point, we were a year in, and the Trump
Administration had provided the country with several FDA-authorized
vaccines, tests, and treatments for COVID-19, while starting a campaign
to vaccinate the most high-risk Americans. That was a significant
accomplishment considering the year before we had never heard of COVID-
19.
The Biden Administration came into the White House with lots of
COVID promises of how it would ``get it under control'' and do so by
``following the science.''
Unfortunately, it appears that the Administration has all but
abandoned that approach, instead making pandemic decisions and policies
based purely on politics.
This has been clear over the past year and half with Federal
vaccine mandates, school closure guidance, and mask requirements on
public transportation that have been overreaching and ripe with
partisan politics.
Most recently, politics appear to have colored every COVID decision
the Department has made.
When CDC announced the termination of the Title 42 Order last
month, which is a public health protocol that limits the number of
illegal immigrants entering the country due to the pandemic, it appears
to have made this decision in a bid to satisfy vocal opponents, without
fully considering the impacts on any other agency, including the
Department of Homeland Security.
Congress has been provided few details as to the impact of this
decision, and as far as I can tell, there is no plan in place for the
influx of illegal immigrants, no real strategy to deal with the
problem, and no money in place to do so.
Further, CDC's decision to vastly increase the number of illegal,
unvaccinated immigrants coming into the country was made after CDC
considered ``current public health conditions and an increased
availability of tools to fight COVID-19.''
Yet just days later, the Department made contradictory decisions to
extend our own country's Public Health Emergency and to appeal the
Federal mask mandate on public transportation that was struck down in
the courts. Even just yesterday, the CDC updated guidance that, two-
and-a-half years into the pandemic, it is now recommending everyone get
tested before domestic travel.
Mr. Secretary, these decisions make no sense. They are
intellectually inconsistent and they send mixed messages to the
American people.
I am afraid that CDC and the Department have now clearly crossed a
line with credibility. And I don't think the American public will
follow public health guidance if they don't trust the agency providing
the guidance. How do you expect Americans to follow your
recommendations when you say it's safe to open the borders to
unvaccinated illegal immigrants, but not safe enough to remove masks on
planes?
Meanwhile, even as the borders reopen as if the pandemic is over,
Americans remain under Federal vaccine and mask mandates and the
Department is asking Congress to provide additional funding for
therapeutics, tests, and vaccines. I want to be very clear: I am
supportive of this funding.
We are not out of the woods yet with COVID-19 and we need to be
prepared for a future wave, to vaccinate the under 5 population, and to
ensure that any American who needs a therapeutic can receive one.
Unfortunately, the Administration made two poor decisions that make
this additional funding nearly impossible.
First, it pushed through a $1.9 trillion, partisan COVID-19 funding
bill that provided less than 1 percent of funding toward vaccines and
therapeutics, and only 5 percent toward COVID-19 public health
priorities.
Simply put, when the Department had the opportunity to purchase
more vaccines, tests, and treatments, to continue researching
additional therapeutics, and to prepare for a disease that we will
likely be facing for the next several years, it failed to do so.
Second, as we were actively negotiating a bill last month to
provide the Department $10 billion to purchase additional therapeutics,
vaccines, and tests, CDC announced the termination of the Title 42
Order.
While this imprudent decision on Title 42 does not lessen the need
for additional funding, it sure makes it significantly harder for
Congress to provide it.
Finally, Mr. Secretary, as it did last year, COVID-19 has once
again overshadowed the budget request. That may actually be a good
thing because this budget is wrought with recycled partisan programs
that I had hoped had been resolved when Congress rejected them in the
last Omnibus.
I once again wholeheartedly disagree with the Administration's
removal of the longstanding Hyde Amendment.
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.
Last year was not any different, and I do not expect this year to be
either.
Mr. Secretary, this Committee has been successful over the last 7
years with passing bipartisan bills because we haven't made
fundamental, drastic funding or policy changes. We've been able to find
agreement on funding for important national priorities, such as ARPA-H
and addressing the substance use disorder crisis and mental health
needs.
As we did in the Omnibus last year, I hope we will set aside
partisan policies to support programs that benefit all Americans.
Thank you, again, for being here today.
Senator Murray. Thank you, Senator Blunt. Again, welcome,
Secretary Becerra. Our witness today is Javier Becerra, the
Secretary of the Department of Health and Human Services.
Again, thank you for joining us. It is important that you are
here. We look forward to your testimony. And with that, you may
begin.
SUMMARY STATEMENT OF HON. XAVIER BECERRA
Secretary Becerra. Chairwoman Murray, Ranking Member Blunt,
and members of the committee, I look forward to discussing with
you the President's fiscal year 2023 budget. But it is most
important that I begin today by responding to the chilling news
that certain justices on the Supreme Court appear to be
plotting to dismantle settled legal authority that recognizes
and protects every woman's right to make her own decisions
about her health and her body, including abortion.
22 years into the 21st century and nearly 50 years after
Roe v. Wade, some, mostly men, seek to impose their judgment
over every woman in America who may seek to exercise their
Constitutional right to privacy in personal decisionmaking.
That is dangerous, that is wrong, and that, we must repel with
every just bone in our body.
America is not a Nation prone to regression, and the
Department of Health and Human Services is not in the business
of stripping Americans of access and protections to care. So at
HHS, we will double down on our authorities to protect every
American's right and access to reproductive healthcare,
including abortion.
Turning to the budget first, to recap, today more than 250
million Americans have received at least one dose of a COVID-19
vaccine, and two-thirds of adults over age 65 have gotten a
booster shot. We have also closed the glaring gap in vaccine
rates across communities often left behind. It has paid
dividends to surge resources, including tests and treatment to
our hardest hit and highest risk communities.
340 million free COVID-19 at home test shipped across
America. 270 million free N95 masks. 100 million booster shots.
Almost $186 billion in provider relief funds distributed
through more than 800,000 payments to over 441,000 providers
for COVID losses and expenses. That is 441,000 hospitals,
community health centers, doctors, pharmacies, nursing homes,
rural health clinics, behavioral health providers, and many
more. Real money, real relief, real results.
That is why it is critical that we have the funds to finish
the fight on COVID-19. It is not just a good investment for our
health and all of our people's health, it is a smart investment
for the health of our economy. Beyond COVID-19, today more
Americans have insurance for their healthcare than ever before
in our country.
That includes a record breaking 14.5 million Americans who
secured health insurance through the Affordable Care Act. Many
of those insured Americans are paying less than $10 per month
in premiums for that solid insurance coverage and the peace of
mind that comes with it. I am also pleased that last week the
FDA issued two proposed tobacco product standards, one
prohibiting menthol as a flavor in cigarettes, and another
prohibiting all flavors in cigars.
These standards are based on scientific evidence and would
improve the health of all Americans. In addition, we launched
Operation Allies Welcome, an HHS led effort that has helped
over 68,000 of our Afghan brothers and sisters resettle as
refugees in America. And we have begun to extend support to
Ukrainian refugees fleeing the Russian invasion of their
homeland.
As you know, we are working to tackle America's mental
health challenges. We are coordinating nearly $300 million with
our 50 States, Tribal governments, and territories to prepare
for the launch of the new three digit 9-8-8 National Suicide
Prevention Lifeline this July. What 9-1-1 is for local
emergency, we are working hard to make 9-8-8 for Americans
experiencing a mental or behavioral health crisis.
On sexual and reproductive healthcare, including access to
abortion care, which is still legal and available, the
Department has worked to restore the Title X Family Planning
Program, awarding $256.6 million in grant funding to restore
access to care nationwide and strengthen program rules. This
importantly, fills service gaps caused by more than a quarter
of Title X providers withdrawing from the program under the
previous Administration's rule.
We have also made funds available to help with clinics in
dire need. Issued guidance under EMTALA (Emergency Medical
Treatment and Active Labor Act) to help patients' access
emergency services safely, and guidance to support providers
against discrimination. We are continuing to do our work to
ensure access to quality care for all patients.
We made these investments to close holes in our public
health system in areas like maternal health, where we have
extended Medicaid coverage for postpartum care for a new mother
and her baby, from 2 months to 12 months. We recently awarded
$16 million to community health organizations to expand HHS
Maternal and Child Home Visiting Program. And we are working
across agencies to make more children eligible for high quality
early education programs like Headstart.
The President's 2023 budget lets us build on that record of
unprecedented investment in America's health. It proposes $127
billion in discretionary budget authority and $1.7 trillion in
mandatory funding, including a standout and historic investment
to transform the mental health infrastructure in our country, a
priority I know you share.
We also ask for $82 billion for the President's pandemic
preparedness and response to get ready for whatever might come
next after COVID-19. Considering that COVID has cost our
country more than $4.5 trillion in direct support from the
Federal Government so far, this is a no brainer to continue
fighting COVID-19 and prepare for any future pandemic.
Madam Chair, members, we are here to turn hardship into
hope, inclusion into opportunity. We look forward to working
with you. And I look forward to answering any questions you may
have.
[The statement follows:]
Prepared Statement of 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) 2023 Budget for the Department of Health and Human Services (HHS).
I am pleased to appear before you today, and I look forward to
continuing to work with you to serve the American people.
HHS addresses many of the challenges facing our country today--
ending the COVID-19 pandemic, reducing healthcare costs, expanding
access to care, improving health equity, ending HIV/AIDS, enhancing
child and family well-being, addressing the overdose epidemic, and
strengthening behavioral health--and we are making meaningful progress
on these priorities. Our work has never been more important, and I am
honored to lead HHS at this critical moment.
The Budget advances the HHS mission to enhance and protect the
health and well-being of all Americans. We are proud to be Congress'
partner in supporting the American people, and we are grateful for the
funding you have provided in support of the HHS mission. We take very
seriously our commitment to ensure we are good stewards of every dollar
in our budget.
Before I dive deeper, I first want to reflect on the Department's
incredible achievements over the past year to save lives and improve
health. Thanks to our work to develop and distribute vaccines and
boosters, nearly 220 million Americans are fully vaccinated against
COVID-19, and two-thirds of adults over age 65 have gotten their
booster shots--an unprecedented accomplishment that saves lives every
day. HHS procured and provided life-saving antivirals, monoclonal
antibodies, and ongoing testing support, with more to come. To date,
HHS has provided critical support that resulted in the emergency use
authorization (EUA) of 3 vaccines (2 of which are now fully licensed),
7 therapeutics, and 29 diagnostics against COVID-19. HHS has procured
millions of COVID-19 treatment courses for Americans, and is supporting
the President's pledge to directly provide 1 billion tests to American
households for free.
Testing capacity has dramatically increased, and we've supplied
free, high-quality masks to the American people. HHS has invested $250
million in U.S.-based manufacturing of personal protective equipment
(PPE) and $950 million in manufacturing the supplies and equipment
needed for vaccines, therapeutics, and diagnostic tests to strengthen
the public health supply chain. We distributed Provider Relief Funds to
support healthcare providers hit hard by the pandemic, and to reimburse
providers for testing, treatment, and vaccine administration for
uninsured patients. We provided guidance to support the safe return to
the classroom, enabling schools nationwide to reopen.
As the President has said, it is critical to get Americans back to
our more normal routines, while still protecting people from COVID-19,
preparing for new variants, and preventing economic and educational
shutdowns. HHS contributions over the past 2 years position our country
to move forward safely, and we look forward to working with you to
continue these efforts.
The country has seen historic increases in health insurance
enrollment through the Marketplaces, with a record 14.5 million people
signed up for 2022 healthcare coverage during the latest Marketplace
Open Enrollment Period. Uninsured rates fell last year after the
American Rescue Plan Act took effect, and continue to fall due to the
success of innovative and targeted consumer outreach campaigns. We are
implementing initiatives like the No Surprises Act, which establishes
new Federal protections against certain kinds of surprise medical
bills. We are preparing for the expansion of the Suicide Lifeline with
the 9-8-8 implementation that will launch this summer. Working with our
interagency partners, we also launched interagency initiatives like
Operation Allies Welcome, a whole-of-government effort that helped over
68,000 Afghans to permanently resettle in 2021.
HHS has made key investments to address disparities and improve
equity and launched new efforts to protect vulnerable communities who
bear the brunt of climate change. We are prioritizing rural health and
the needs of our Tribal partners. We released a new HHS Overdose
Prevention Strategy and made significant investments in behavioral
health. It is also an Administration priority to advance legislation
that helps lower costs for families, including for child care,
preschool, and long-term care, and I look forward to working with
Congress to achieve this together.
The President's Budget will enable us to continue these critical
efforts and achieve our mission in fiscal year 2023. The fiscal year
2023 Budget proposes $127.3 billion in discretionary and $1.7 trillion
in mandatory budget authority, including newly proposed mandatory
funding for the Indian Health Service and an historic mandatory funding
request to transform our ability to protect the nation from future
pandemics and other biological threats. The Labor-HHS-Education total
is $123.4 billion, an increase of $12.9 billion. These investments
support families through early education, behavioral health, and access
to care. The Budget demonstrates the Administration's commitment to
reinvesting in public health, research, and development to drive growth
and shared prosperity for all Americans by making major investments in
priority areas, including overdose prevention, mental health, maternal
health, cancer, and HIV/AIDS. COVID-19 has shown that health inequities
and insufficient Federal funding leave communities vulnerable to these
crises. The Budget advances equity and helps ensure our programs serve
people of color and other underserved communities with the
opportunities promised to all Americans.
tackling covid-19 and preparing for the next biological threat
First, I want to highlight that although HHS has made tremendous
progress in the fight against COVID, we now face a dire moment. As you
know, the Administration requested $22.5 billion for immediate needs to
avoid severe disruptions to our COVID response. We requested these
funds as emergency resources, in the same way Congress provided
multiple times on a bipartisan basis under the prior Administration. We
face unavoidable impacts of not receiving these resources. Testing and
treatment capacity will decline. The uninsured fund--which offers
coverage of testing, treatments, and vaccinations for tens of millions
of Americans who lack health insurance--will run out of money and stop
paying provider claims. Already, it has stopped accepting provider
claims for testing, treatment, and vaccine reimbursement. Many
Americans will no longer be able to access life saving monoclonal
antibodies and antiviral drugs. We will be unprepared for a new variant
and unable to provide life-saving vaccines to the American people. It
is critical that we work together to avoid these and other severe
consequences.
Beyond the need for investment in immediate COVID-19 response
requirements, the fiscal year 2023 budget builds on Congress' response
investments to transform our preparedness for biological threats and
strengthen national and global health and health security. The Budget
includes a historic $81.7 billion in mandatory funding over 5 years
across the Office of the Assistant Secretary for Preparedness &
Response (ASPR), CDC, the National Institutes of Health (NIH), and the
Food and Drug Administration (FDA) to support the Administration's
vision for pandemic preparedness.
This request provides $40 billion to the Office of the Assistant
Secretary for Preparedness and Response to invest in advanced
development and manufacturing of countermeasures for high priority
threats and viral families, including vaccines, therapeutics,
diagnostics, and personal protective equipment. It provides $28 billion
for the Centers for Disease Control and Prevention (CDC) to enhance
public health system infrastructure, domestic and global threat
surveillance, public health workforce development, public health
laboratory capacity, and global health security. It provides $12.1
billion to NIH for research and development of vaccines, diagnostics,
and therapeutics against high priority biological threats; biosafety
and biosecurity research and innovation to prevent biological
incidents; and safe and secure laboratory capacity and clinical trial
infrastructure. The Budget also includes $1.6 billion for the Food and
Drug Administration to expand and modernize regulatory capacity
information technology, and laboratory infrastructure to support the
evaluation of medical countermeasures.
Collectively, these activities will build capabilities the nation
urgently needs to respond to future pandemics and biological threats
from any source, strengthen international systems so that we can detect
threats early and respond to threats quickly, and enable us to boldly
and decisively act on the lessons from COVID-19.
In addition to this mandatory investment, the Budget also funds
critical ongoing response and preparedness efforts through
discretionary budgets. The HHS Coordination Operations and Response
Element (H-CORE) within ASPR is responsible for coordinating the
development, production, and distribution of COVID-19 vaccines and
therapeutics. The Budget requests $133 million for H-CORE, which is
critical to beat COVID-19 and for future emergency response efforts
beyond the pandemic, as ASPR builds an enduring response
infrastructure. These resources will support the necessary staffing,
acquisition support, and data analytics for COVID-19 countermeasures
when emergency funding is no longer available to cover these costs.
The Budget requests $828 million for the Biological Advanced
Research and Development Authority (BARDA), to develop novel medical
countermeasure platforms to enable quicker, more effective public
health and medical responses to detect and treat infectious diseases.
The Budget also requests $975 million for the Strategic National
Stockpile to sustain and expand the current inventory of supplies to
ensure readiness for potential future pandemics.
COVID-19 has shown the importance of timely, reliable data to
respond effectively to public health threats. The Budget makes robust
investments in science and public health to improve and protect health
at home and abroad, including at CDC for public health infrastructure
and capacity, data modernization, global public health protection, and
the Center for Forecasting and Outbreak Analytics. The Budget also
includes $197 million to expand state, local, tribal, territorial, and
international capacity to combat antibiotic resistance at CDC, as well
as an HHS-wide mandatory proposal to encourage the development of
innovative antimicrobial drugs.
advancing science and research
The Budget prioritizes research and scientific advancement. We are
grateful for the support from Congress to establish the Advanced
Research Projects Agency for Health (ARPA-H), and the Budget proposes
$5.0 billion to revolutionize how to prevent, treat, and even cure a
range of diseases including cancer, infectious diseases, Alzheimer's
disease, and many others. This funding is part of a proposed $49.0
billion in discretionary funds for NIH to continue its incredible track
record of turning discovery into health. NIH invests in basic research
and translation into clinical practice to address the most urgent
challenges including preparing for future pandemics, reducing health
disparities and inequity, driving innovative mental health research,
and ending the overdose crisis.
The Budget proposes investments in NIH, CDC, and FDA to reignite
the President's Cancer Moonshot with an ambitious goal to reduce the
death rate from cancer by at least 50 percent over the next 25 years,
improve the experience of people and their families living with and
surviving cancer, and end cancer as we know it today. The Budget
includes increases for CDC to enhance a range of cancer related
programs and for FDA's Oncology Center of Excellence.
The Budget proposes $6.8 billion for FDA to continue to work with
developers, researchers, manufacturers, and other partners to help
expedite the development and availability of therapeutic drugs and
biological products, and to apply the best science in its food and
tobacco work. The Budget also proposes $527 million program level
resources for the Agency for Healthcare Research and Quality (AHRQ) to
support evidence-based research, data, and tools to make healthcare
safer, higher quality, more accessible, equitable, and affordable for
all Americans.
Importantly, the Budget also includes $25 million for CDC and $20
million for AHRQ to launch Centers for Excellence to study long COVID
conditions and equip healthcare providers and systems to deliver
patient-centered, coordinated care for this patient population.
reducing health care costs and expanding access to care
To enhance the health and well-being of all Americans, the Budget
makes access to more affordable healthcare a top priority. The
Affordable Care Act (ACA), bolstered by the American Rescue Plan, has
expanded health insurance coverage to historic numbers of Americans and
the Budget builds on that legacy.
The American Rescue Plan made groundbreaking investments in the ACA
by expanding premium subsidies to make coverage affordable for millions
more Americans. As I mentioned earlier, a record-breaking 14.5 million
people have signed up for 2022 healthcare coverage through the
Marketplaces during the latest Marketplace Open Enrollment Period,
including nearly 6 million people who have newly gained coverage. The
American Rescue Plan lowered healthcare costs for most consumers and
increased enrollment to record levels. In fact, consumers saw their
average monthly premium fall by 23 percent compared to the prior open
enrollment period. As you know, the American Rescue Plan subsidies will
expire at the end of 2022 and without new legislation this will result
in millions of Americans losing this more affordable coverage. I look
forward to working with the Congress on this key priority. We are also
concerned about millions of vulnerable Americans who could lose their
Medicaid coverage when the COVID-19 Public Health Emergency ends. To
address this concern, CMS has provided multiple rounds of guidance to
state Medicaid and CHIP agencies that include a robust selection of
best practices and recommended strategies allowed under current law
when returning to routine operations after the Public Health Emergency
ends. For example, recently, CMS released a State Health Official
Letter that extends the time states have to process Medicaid
redeterminations after the end of the Public Health Emergency from 12
months to 14. HHS is also working to increase awareness of coverage
options through targeted outreach campaigns and making renewal of
coverage for those eligible easier to navigate. We also look forward to
working with the Congress to find solutions to providing coverage
options for the nearly 4 million Americans in non-covered states.
Additionally, the Administration supports strengthening home and
community-based services as an alternative to institutionalized care,
to ensure people have access to safe options that work for them.
Rising healthcare costs affect all Americans. HHS has taken steps
to increase competition, improve transparency, and strengthen consumer
protections. Under the No Surprises Act, a critical bipartisan law
passed by Congress, HHS continues to implement the law that shields
consumers from certain kinds of surprise medical bills and requires
greater transparency from providers. HHS also issued a proposed rule to
make hearing aids available to individuals over-the-counter that can
help provide consumers with more affordable options and lead to a more
competitive market.
I look forward to working with the Congress to lower healthcare
costs and expand and improve coverage for all Americans. Reaffirming
the President's charge in his State of the Union address, we will work
to lower the costs of prescription drugs, such as by capping the cost
of insulin at $35 per month, and to allow Medicare to negotiate payment
for certain high-cost drugs.
During the COVID-19 public health emergency, telehealth has been a
reliable resource for providers to reach patients directly in their
homes to ensure access to care and continuity of services. The
Administration is committed to supporting a temporary extension of
broader telehealth coverage under Medicare beyond the declared COVID-19
Public Health Emergency to study its impact on utilization of services
and access to care. I want to thank Congress for provisions included in
the fiscal year 2022 Omnibus spending bill that extend Medicare
telehealth flexibilities for 5 months after the end of the public
health emergency.
Additionally, the COVID-19 pandemic highlights the importance of
vaccines and prevention. Long- standing, deep disparities exist in
adult vaccination coverage based on race and ethnicity, particularly
among Black and Hispanic populations as compared to other groups. The
Budget proposes Vaccines for Adults, a new mandatory program modeled
after the existing Vaccines for Children (VFC) program, to provide
uninsured adults with access to vaccines, free of charge, that are
recommended by the Advisory Committee on Immunization Practices. The
Budget further expands the VFC program to include all children under
age 19 enrolled in the Children's Health Insurance Program. The Budget
also includes a proposal to consolidate Medicare coverage of vaccines
under Part B, which will make vaccines more accessible, remove
financial barriers, and streamline the process for Medicare
beneficiaries and providers.
The Budget continues to support the fourth year of the Ending the
HIV Epidemic initiative with $850 million in funding across CDC, HRSA,
IHS, and NIH for fiscal year 2023. The initiative is critical to
achieve President Biden's plan to end the HIV/AIDS epidemic by 2030 and
ensure access to HIV prevention, care, and treatment. HHS works closely
with communities to support the four key strategies--Diagnose, Treat,
Prevent, and Respond--to end the HIV epidemic. The Budget also creates
a national program that invests $9.8 billion over 10 years to provide a
financing and delivery system to ensure everyone has access to pre-
exposure prophylaxis, also known as PrEP, and essential wraparound
services.
tackling health and human services disparities
Advancing equity is at the core of the Budget. HHS works to close
the gaps in access to healthcare and human services to advance
equitable outcomes for all, including people of color and others who
have been historically underserved, marginalized, and adversely
affected by persistent poverty and inequality. HHS is committed to
carrying out the President's Executive Order 13985 on Advancing Racial
Equity and Support for Underserved Communities Through the Federal
Government. Even before the pandemic, we were not doing enough to
provide equitable preventive measures, services, and treatment options
in every community--and COVID has only made this disparity worse.
Maternal mortality in the United States is significantly higher
than most other developed nations and is especially high among Black
and Native American/Alaska Native women, regardless of their income or
education levels. The Biden-Harris Administration is committed to
promoting maternal health and ensuring equitable access to affordable,
quality healthcare for our nation's mothers. The Budget invests over
$470 million across AHRQ, CDC, HRSA, IHS, and NIH to reduce maternal
mortality and morbidity. This includes increased funding to CDC's
Maternal Mortality Review Committees and other Safe Motherhood
programs, HRSA's State Maternal Health Innovation Grants program and a
new Healthy Start program initiative, and other maternal health
programs across HHS.
The Budget also invests in maternal and broader women's health and
health equity, including $86 million for the Office of Minority Health
to focus on areas with high rates of adverse maternal health outcomes
and areas with significant racial or ethnic disparities. In addition,
the Budget also includes $42 million for the Office on Women's Health
to fund prevention initiatives that address health disparities for
women.
Black and Latino/Hispanic people, along with American Indian/Alaska
Native people, are much less likely than white people to have health
insurance. Evidence shows that expanding coverage is not only essential
for facilitating equitable access to healthcare, but also is associated
with reduced morbidity and mortality, poverty reductions, and
protection from debilitating financial bills. The Budget supports
policies to promote a stronger and more equitable health insurance
system beginning with new requirements for data on race and ethnicity
in Medicare.
The Budget also invests $35 million for a new initiative to
systematically identify and resolve barriers to equity in each Centers
for Medicare & Medicaid Services (CMS) program through research, data
collection and analysis, stakeholder engagement, building upon rural
health equity efforts, and technical assistance. CMS is committed to
obtaining more accurate and comprehensive race and ethnicity data on
Medicare beneficiaries, and to require reporting on social determinants
in post-acute healthcare settings. CMS also proposes to add Medicare
coverage for services furnished by community health workers who often
play a key role in addressing public health challenges for underserved
communities. These proposals will help identify, mitigate, and lessen
health disparities.
Health Centers are the first line of defense in addressing
behavioral health issues nationwide when resources are available. This
is particularly true for underserved populations, including low-income
patients, racial and ethnic minorities, rural communities, and people
experiencing homelessness. The Budget provides $5.7 billion for health
centers, including $3.9 billion in mandatory resources.
The COVID-19 pandemic has further disrupted access to reproductive
health services and exacerbated inequalities in access to care. HHS
commits to protecting and strengthening access to reproductive
healthcare, and the Budget proposes $400 million to the Title X family
planning program to address increased need for family planning
services. Title X is the only Federal grant program dedicated solely to
providing individuals with comprehensive family planning and related
preventive health services in communities across the United States.
The Budget increases services to prevent child maltreatment and the
need for foster care, and supports states in moving towards child
welfare systems that provide more tailored and comprehensive prevention
services to a broader, more diverse group of families. Prevention
services and support are particularly important for at-risk Black,
Latino, Indigenous, Native American, and members of other under-served
communities, which have disproportionate involvement with the child
welfare system.
The Budget provides $3.1 billion for the Administration for
Community Living (ACL), reflecting significant demand increases for
critical services caused by population growth and pandemic impacts. ACL
supports caregivers and advances equitable access to healthcare,
education, employment, transportation, recreation, and other systems,
resources, and opportunities. ACL advances equity by targeting those in
greatest social and economic need, with particular attention on people
with disabilities and older adults who are marginalized due to race,
ethnicity, sexual orientation, gender identity, poverty, language
spoken, and who are at risk of institutionalization.
Lastly, the Budget takes a historic first step toward redressing
health disparities faced by American Indians and Alaska Natives by
proposing all funding for the Indian Health Service (IHS) as mandatory.
In fiscal year 2023, the Budget provides $9.3 billion, which includes
$147 million in current law funding for the Special Diabetes Program
for Indians. This substantial funding increases of $2.5 billion above
fiscal year 2022 enacted will support direct healthcare services,
facilities and IT infrastructure, and management and operations. It
also provides targeted increases to address key health issues that
disproportionately impact American Indians and Alaska Natives such as
HIV, Hepatitis C, opioid use, and maternal mortality. With current law
funding for the Special Diabetes Program for Indians, the total program
level for IHS is $9.3 billion in fiscal year 2023.
To address chronic underinvestment in IHS, the Budget increases
funding for each year over 10 years, building to $36.7 billion in
fiscal year 2032. This increase of 296 percent over the ten-year budget
window accomplishes funding growth beyond what can be accomplished
through discretionary spending. Over a five-year period, the budget
will reduce existing facilities backlogs, fully fund the level of need
identified by the Federal-Tribal Indian Health Care Improvement Fund
workgroup and support the modernization of the IHS electronic health
record system. Additionally, the Budget grows IHS funding to keep pace
with inflation and population growth. This request responds to the
long-standing recommendations of tribal leaders shared in consultation
with HHS to make IHS funding mandatory, and HHS will continue
consulting with tribes to inform future policy and budget requests. HHS
appreciates the strong partnership with Congress to grow funding for
the IHS budget over the last decade, and looks forward to continuing
our shared efforts to improve healthcare in Indian Country.
strengthening behavioral health
HHS is committed to combating America's mental health and substance
use crises. The pandemic has had a devastating impact on mental health,
particularly for young people, by dramatically changing Americans'
experience of home, of school, of work, and in their communities. The
President has outlined a bold strategy for tackling the nation's mental
health crisis, calling for an increased focus on building system
capacity, connecting more people to care, and creating a continuum of
support to keep people healthy and help Americans thrive. I also
recently launched a National Tour to Strengthen Mental Health, to hear
directly from Americans across the country about the mental health and
substance use challenges they're facing and to engage with local
leaders to strengthen the mental health and crisis care system in our
communities. We are also working with the Department of Education to
develop and align resources to ensure children have the physical and
behavioral health services and supports that they need to build
resilience and thrive. Individuals who develop substance use disorders
are often also diagnosed with mental disorders--the budget addresses
the significant connection between mental health and substance use by
investing in a broad spectrum of behavioral health services.
The Budget includes new, historic mandatory investments in totaling
$51.7 billion over 10 years to address the nation's behavioral health
crisis. In support of the President's call for reforming our mental
healthcare system to fully meet the needs of our communities, the
Budget includes a new $7.5 billion Mental Health Transformation Fund,
allocated over a 10 year period, to increase access to mental health
services through workforce development and service expansion, including
through healthcare and community settings that have not traditionally
provided mental health services but that are well-positioned to reach
more people. The Mental Health Transformation Fund will also support
the expanded use of evidence-based practices for mental healthcare, to
ensure that families and communities affected by mental illness receive
the highest quality care and supports.
The Budget improves Medicare coverage of mental healthcare and
makes access to such care more affordable by eliminating the 190-day
lifetime limit on psychiatric hospital services and requiring Medicare
to cover three behavioral health visits per year without cost-sharing.
In addition, the Budget would recognize licensed professional
counselors and marriage and family therapists as independent
practitioners who are authorized to furnish and receive direct Medicare
payment for their mental health services, aligns the criteria for
psychiatric hospital terminations from Medicare with that of other
healthcare providers, and applies the Mental Health Parity and
Addiction Equity Act to Medicare.
Additionally, the Budget establishes a Medicaid provider capacity
demonstration program for mental health treatment and establishes a
performance bonus fund to improve behavioral health services in
Medicaid. The Budget also expands and converts the Demonstration
Program to Improve Community Mental Health Services into a permanent
program. Further, the Budget prevents states from prohibiting same day
billing and allows providers to be reimbursed for Medicaid mental
health and physical health visits provided to a Medicaid beneficiary
that occur on the same day and requires that Medicaid behavioral health
services, whether provided under fee-for-service or managed care, be
consistent with current and clinically appropriate treatment
guidelines.
For people with private health insurance, the Budget requires all
health plans to cover mental health and substance use disorder benefits
and ensures that plans have an adequate network of behavioral health
providers. The Budget also establishes grants to states to enforce
parity between mental and substance use disorder and other medical
benefits.
The Budget also proposes $20.8 billion in discretionary funding for
behavioral health programs in fiscal year 2023, including significant
investments in mental health programs such as the National Suicide
Prevention Lifeline, a free, confidential 24/7 phone line that connects
individuals in crisis with trained counselors across the United States.
The Lifeline receives calls from people with substance use; depression;
mental and physical illness; economic worries; loneliness; and concerns
about relationships and sexual identity. Ensuring the success of the
Lifeline particularly as it transitions to the universal 3-digit number
988 is a top priority for HHS.
To support the health workforce, the Budget includes $397 million
for Behavioral Health Workforce Development Programs and $25 million in
the National Health Service Corps funding specifically for mental
health providers. The Budget also includes $50 million for the Health
Resources and Services Administration (HRSA) for Preventing Burnout in
the Health Workforce. This investment will provide crucial support for
health workforce retention and recruitment, which is essential for
addressing current and future behavioral health workforce shortages.
Suicide remains the second leading cause of death among young
people between the ages of 10 and 34. Many youth, especially young
people of color, Indigenous youth, and LGBTQ+ youth, still lack access
to affordable healthcare coverage that is necessary for them to receive
treatment for mental health conditions.
The Budget also includes $308 million for Project AWARE and the
Mental Health Awareness Training program to expand support for
comprehensive, coordinated, and integrated state and tribal efforts to
adopt trauma-informed approaches and increase access to mental health
services. School and community-based programs like Project AWARE have
been shown to improve mental health and emotional well-being of
children at low cost and high benefit. Prevention is an investment in
our future, and it lowers adverse outcomes with high societal impact.
According to CDC data, drug overdose deaths increased nearly 30
percent in 2020. Last fall, I announced the release of a new,
comprehensive HHS Overdose Prevention Strategy for the nation, designed
to increase access to the full range of care and services for
individuals with substance use disorders and their families. This new
strategy focuses on the multiple substances responsible for overdose
and the diverse treatment approaches needed to address them.
The Budget invests $11.0 billion to combat the overdose crisis
across HHS in support of four key target areas--primary prevention,
harm reduction, evidence-based treatment, and recovery support--and
reflects the Biden-Harris Administration principles of equity for
underserved populations, reducing stigma, and evidence-based policy.
The Budget also proposes $553 million for Certified Community
Behavioral Health Centers Expansion Grants to provide coordinated,
high-quality, comprehensive behavioral health services. The Budget also
proposes to remove the word ``abuse'' from the agency names within
HHS--including the Substance use And Mental Health Services
Administration, the National Institute on Alcohol Effects and Alcohol-
Associated Disorders, and the National Institute on Drugs and
Addiction. Individuals do not choose to ``abuse'' drugs and alcohol;
they suffer from addiction, which is a chronic medical condition. It is
a high priority for this Administration to move past outdated and
stigmatizing language that is harmful to these individuals and their
families.
supporting children, families, and seniors
HHS has a responsibility to ensure our programs serve children
equitably, and the high-quality care of children positively impacts
their success later in life. The Budget proposes $20.2 billion in
discretionary funding for the Administration for Children and Families'
early care and education programs. This includes $12.2 billion for Head
Start to provide services to more than a million children, pregnant
women, and families, $7.6 billion for the Child Care and Development
Block Grant, and $450 million for Preschool Development Grants to
increase capacity of states to expand preschool programs.
The Budget expands home visiting programs over 5 years to provide
economic assistance, child care, and health support for up to 165,000
additional families at risk for poor maternal and child health
outcomes. This funding will help strengthen and expand access to home
visiting programs that provide critical services directly to parents
and their children in underserved communities.
The mandatory budget includes a $4.9 billion expansion of services
to prevent child maltreatment and the need for foster care. For
children who must be removed from their parents, the Budget includes
$1.3 billion in support for states to prioritize placing children with
kin, as well as a $3 billion increase for programs to stabilize and
support families and adoptive families, and a $1 billion increase in
support for the transition to adulthood for youth who experienced
foster care. While not part of HHS's budget, the Budget proposes to
make the adoption tax credit fully refundable so that more families can
benefit and to expand the credit to include qualifying legal
guardianships.
We face a public health crisis of violence in our communities,
which disproportionately affects communities of color. The Budget
includes $250 million for CDC for the Community Violence Intervention
initiative, in collaboration with Department of Justice to implement
evidence-based community violence interventions at the local level, as
well as funding for firearm violence prevention research. The Budget
also promotes prevention of and early intervention after adverse
events, like community violence, to mitigate longer term impacts,
including $15 million for CDC to advance surveillance and research
aimed at preventing Adverse Childhood Experiences. The Budget also
includes $519 million for ACF's Family Violence Prevention and Services
programs, including $250 million to provide direct cash assistance to
survivors of domestic violence.
The Budget supports FDA's public education campaigns to educate
youth about the dangers of e-cigarette use; provide resources to
educators, parents, and community leaders to prevent youth use; and
provide resources to help kids who are already addicted to e-cigarettes
quit using these harmful products. The Budget includes $812 million for
FDA's tobacco program, an increase to enhance product review and
evaluation, research, compliance and enforcement, public education
campaigns, and policy development.
The Administration for Community Living (ACL) protects seniors and
persons with disabilities from abuse through investments in Adult
Protective Services and the Long-Term Care Ombudsman Program. As the
populations served by ACL continue to grow, the Budget provides $139
million to protect vulnerable older adults. The Budget also bolsters
ACL's role as an advocate for older adults and people with
disabilities.
refugees and unaccompanied children
Amid the COVID-19 pandemic, large numbers of unaccompanied children
continue to arrive at our Southern border. HHS is committed to
fulfilling our legal and humanitarian responsibility to care for all
unaccompanied children (UC) referred to us by Federal partners. The
fiscal year 2023 Budget includes $6.3 billion in discretionary funding
for the Office of Refugee Resettlement, including $4.9 billion for the
unaccompanied children program so that HHS may continue to care for UC
safely and humanely, in alignment with child welfare best practices.
The Budget also proposes a mandatory contingency fund to provide
additional funds if there is a surge in UC referrals, as well as
mandatory funding to build towards universal UC legal representation.
HHS is committed to unifying these children with vetted sponsors,
usually a parent or close relative, as safely and quickly as possible,
and the Budget includes funding to implement critical programmatic
reforms and service expansions. The Budget also builds on the nation's
refugee infrastructure to support resettling of up to 125,000 refugees
in 2023, and requests authority to use these funds to support the
successful reunification of families who were cruelly separated under
the Trump Administration.
improving safety and oversight nursing homes
Building on the President's State of the Union Address, the Budget
is committed to ensuring nursing homes are safe and providing high
quality care to vulnerable Americans by increasing funding for nursing
home health and safety inspections by nearly 25 percent. Additionally,
by increasing nursing home owners' accountability for minimum quality
standards, noncompliant facilities can be held financially responsible
for poor safety and care. The Budget also requests authority to publish
accreditation surveys for other healthcare facilities, like hospitals,
rural health clinics, and ambulatory surgical centers, which will
better inform the public when selecting care locations for loved ones.
The Administration also supports strengthening home and community-based
services to ensure people have access to safe options that work for
them.
funding core program operations
While the service provided by HHS continues to grow, investment in
the Department's operational needs ensures HHS can carry out its
mission to enhance and protect the health and well-being of all
Americans while maximizing our resources. This investment 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 importance and magnitude of HHS' work, ensuring the
integrity of our spending is a core value and responsibility of HHS.
The Budget increases discretionary Heath Care Fraud and Abuse Control
program spending to a total of $899 million to provide oversight of CMS
health programs, strengthen OIG investigations, and protect
beneficiaries against healthcare fraud, yielding a return-on-investment
of $13.6 billion over 10 years. The pandemic has unleashed new
healthcare fraud risks related to the implementation of billions in new
Federal spending, as well as multiple provider regulatory and other
flexibilities. These funds are critical to help HHS root out bad actors
and ensure program integrity.
conclusion
I want to thank the Committee for inviting me to discuss the
President's fiscal year 2023 Budget for HHS. The Budget offers a vision
for the nation that reinvests in America's health, supports growth and
prosperity, and meets our commitments to the American people and
especially to the most vulnerable. I look forward to working with you
to fulfill that vision. If we step up in this moment, we can lay the
foundation now.
These are critical programs and issues that deserve attention and
adequate funding. Thank you for your partnership in advancing our
shared goal to improve the health, safety, and well-being of our
nation.
Senator Murray. Thank you very much, Mr. Secretary. We will
now begin a round of 5 minute questions of our witness. I ask
my colleagues, please keep track of the clock and stay within
your 5 minutes.
TITLE X
Secretary Becerra, when Texas passed its highly restrictive
abortion ban, President Biden promised a whole of Government
response. And in a statement yesterday, he said the
Administration will be ready when any ruling is issued. What
can you tell us about the Administration's plan for a whole of
Government response to defend the right to abortion?
Secretary Becerra. Madam Chair, as I mentioned before, we
are working at HHS through a reproductive healthcare task force
that we established to make sure that we continue to protect
the rights of women that exist today. Those rights that exist
today to have access to care. We have expanded program services
like Title X, and we will work with all of our partners
throughout the Federal Government to make sure that every woman
has the legal right to access the care that she is entitled to.
Senator Murray. Well, I have been really alarmed that some
Republicans have made it clear they don't intend to stop at
abortion. Some saying the case that ruled against birth control
bans was wrongly decided.
And they have refused to increase funding for the Title X
program, which I have been talking about, that provides funding
for birth control, cancer screening, and lifesaving care. And
in fact, they voted to undermine that program just last week.
Now, HHS approved, but had to turn away dozens of highly
qualified applicants for this program in March as a result of
that funding. Can you tell us what that means for patients?
Secretary Becerra. First, I want to make note that because
Congress was successful in passing its omnibus budget, we are
going to be able to do far more than what the President's
budget first proposed, because it was based on a baseline using
the continuing resolution funding levels.
So we will do much more working with you to make sure
adequate funds are available for programs that provide women
access to the care that they need. We are also going to make
sure that we speak to all those providers who are out there who
have an obligation to make sure women are receiving the
services they are entitled to.
I yesterday spoke to a number of health plans and
representatives of various health plans throughout the country
to make it clear that we intend to enforce the law when it
comes to women accessing the care that they are entitled to.
Senator Murray. Can you tell us how the proposed increase
in HHS will expand access for women of color and low income
women?
Secretary Becerra. We are working hard to make sure that we
are addressing some of the maternal mortality and morbidity
circumstances that we see in this country, where typically a
woman in the black community and in our native populations will
suffer the consequences of lost birth, possibly a loss of life,
in far greater numbers, probably 3 to 1 compared to in the
white community.
And so we are investing in the President's budget close to
half a billion dollars to increase our services in maternal
health and mortality. We are also calling on States through the
American Rescue Plan to increase the number of days that a
woman is entitled to postpartum care from 60 days under
Medicare, Medicaid--excuse me, to 365 days under Medicaid.
COVID-19 Funding
Senator Murray. Okay. Thank you. On another topic, I am
really concerned that further delay in passing emergency COVID
funding could undermine our hard won progress. What are the
immediate effects if Congress does not provide more funding for
the COVID-19 response as soon as possible?
Secretary Becerra. Madam Chair, thank you for that
question. I have said this publicly many times, we have been
first in line to receive vaccines, some of the therapeutics,
the antiviral medications, because we have been at the
beginning of the negotiations to have access to those therapies
and drugs.
Without the money to make the long term commitment going
forward, we can't assume that we will get first in line. Many
other countries are already negotiating for access to those
treatments. And what we need to do is plan ahead. We have a
stock right now of vaccines and treatments that cover us for
the next several months.
But we can't say that if there is a new variant that hits
or if we need to buy the next generation vaccine that we'll be
the first in line if we don't have the money.
Senator Murray. Meaning there is a limited supply, and we
won't have access to that supply unless we have the funds
available now?
Secretary Becerra. Correct.
Senator Murray. Okay. Parents across the country are
waiting anxiously for vaccines for young kids. I know FDA is
working on this, but having safe, effective vaccines is the
first step, and we need the Administration to be ready to
distribute enough doses and make it easy for parents to get
them for their kids. Are you ready for that?
Secretary Becerra. We are ready and anxious, as anxious as
you are. As you said, safe and effective are the key words. FDA
will move when they have the data that reflects if they are
safe and effective to use for those under 5 years of age. And
we are already coordinating with a number of providers,
including pediatricians, to make sure we are making those
available as quickly as possible.
Senator Murray. Do we have enough doses available, once it
is approved?
Secretary Becerra. We will be able to purchase, because we
made a reservation of funds to make sure we could purchase. But
once again, how much, how far, and what the vaccine might look
like will determine whether or not we have access to the supply
we need.
Senator Murray. Thank you very much. Senator Blunt.
ARPA-H
Senator Blunt. Thank you, Chair. Let's talk about ARPA-H
for a little bit. This for people who have not been thinking
about--an idea the President has to take the long experience
with DARPA, Defense Advanced Research, which is different than
the way we have done basic health research, and in those
instances where we can work toward a rapid conclusion and a
more hands together partnered way to do that, I am for that.
Chair Murray has supported the approach of trying to get
there quickly as she and Senator Burr have introduced
legislation to codify this concept. I really want to ask two
questions here, and one is, talk a little bit about your
decision to structurally put ARPA-H under the NIH umbrella but
directly reporting to you, and then we will come to the
spending decision later.
Secretary Becerra. Senator, thank you for the question and
the support you provided to ARPA-H. ARPA-H at the end of the
day is like NIH, an agency that takes that research. But how it
differs from NIH is it wants to be able to launch from the pad
very quickly. And working in partnership with the private
sector, those innovators that are out there, the biomedical
scientists, be able to actually give the American people a
product quickly.
And that is why we want ARPA-H to be more nimble, more
facile, and have the opportunity to break away from the tethers
of governance that you see at NIH to be able to launch as
quickly as possible. We believe we are going to be able to do
that while using the efficiencies at NIH has.
So, for example, starting up, your human relations office,
your payroll office, your accounting office, rather than have
ARPA-H have to start from very scratch, make use of what NIH
provides, but give them the autonomy to launch the way they
think fit.
Senator Blunt. And at ARPA-H, I think is, I have heard that
discussed while all of those assets would be there, the
umbrella agency of NIH, the ARPA-H system would not necessarily
work like the NIH system.
You would have the ability to bring people in for shorter
periods of time, understanding that this is a project, we are
bringing you in to work on it, and at the end of, say, 3 years,
we expect this project to be done and you will have the ability
to go on to some other work somewhere else. Is that your
understanding of this as well, Secretary?
Secretary Becerra. That is correct. It will not work the
way NIH works. It will work much closer to what you understand
the way DARPA works in the Department of Defense.
Senator Blunt. I do think that NIH showed during COVID with
RADx and with some of the Warp Speed involvement that even NIH
had, but particularly gives RADx the ability to do things in a
different way. But I think looking at how that worked and how
DARPA works and figuring out how they all work together would
be a good thing.
So Senator Murray and I have worked together on this
committee for 7 years, and have increased the NIH funding by
more than 50 percent after a decade with no real increase. It
has been an important goal that we have worked on together. The
concern at NIH about ARPA-H--or the NIH advocates, not
necessarily the people working there, but the support groups
and advocates of NIH, has always been that it would take money
that otherwise would go to NIH. It appears that is exactly what
is happening here.
We did $1 billion for startup money for ARPA-H last year.
This budget proposes another $4 billion for ARPA-H and zero for
NIH. I am confident that based on our past, working on this
topic, zero will not be the number we come up with. But why did
you submit zero as opposed to an increase in NIH and money for
ARPA-H as well?
Secretary Becerra. Appreciate the question and to explain.
We, when the President asked us to submit our budgets to
Congress, we had to work with the baseline that we knew that
was in front of us.
At that point, Congress had not completed the work on a
fiscal year 2022 budget, and so we had to operate expecting
that our baseline would be the continuing resolution, which is
far lower than what you ultimately passed in the omnibus bill
for 2022.
Certainly now, knowing what the omnibus bottom line is for
NIH, we will work using that bottom line to talk about
increases for NIH. And we look forward to working with you to
make sure that NIH continues to receive the robust funding that
it has always received from Congress.
Senator Blunt. Thank you, Senator Murray. I will have some
other questions, but I assume we will have a chance to ask a
second round of questions.
Senator Murray. Yes, we will do that. Thank you. Senator
Manchin.
SUPPLY CHAIN
Senator Manchin. Secretary, thank you for being here.
Appreciate it. Thank you for your service. On supply chains, we
have spoken quite a bit about supply chains, and we learned
that during the COVID-19 pandemic, how fragile it is and trying
to make sure that we are able to meet the needs of the people.
This Administration, Biden Administration, they instituted
a whole of Government effort to assess what can be done to
strengthen competitiveness and supply chain resilience,
including the 100 day reviews. And later this year, I think you
all will issue your first annual report to provide an update on
the challenges, developments, and opportunities.
So the only thing, I know that we are running into these
timeframes and everything, so I guess what progress has the
Department made in confronting this supply chain crisis that
jeopardizes the supply of medications that patients are going
to rely on and need?
Secretary Becerra. Senator, I look forward to working with
you on that. As you know, this Administration has used the
Defense Production Act on several occasions to try to increase
and expand our supply chain. Quick example.
Last year, all the manufacturers of COVID test kits were
not domestic, and we worked really hard not only to expand the
number of testing kits that would be available for Americans to
test themselves against COVID, but we worked really hard to
make sure those were domestically manufactured.
And today we have several in America that are domestically
manufactured, which, by the way, they will begin to shut down
those lines of production if we don't have the monies to
guarantee that we will be able to fund test kits moving into
the future.
Senator Manchin. You have been able to track manufacturing,
but people are willing to come back into our manufacturing
base?
Secretary Becerra. Absolutely.
LIHEAP
Senator Manchin. You show them the support, they will be
there. Okay. The other thing is on LIHEAP, the LIHEAP, Low
Income and Energy Assistance Program. We are having a hard
time, and advocates both from back home in West Virginia and
nationally, challenge in the States facing administering this
program. They are having trouble getting the people to
administer the program and getting the money to be
administered.
So I guess, quickly, have you all looked into this, and can
you look into it on LIHEAP, how you can maybe help or make sure
that money is getting there, or they have the administration
that they are going to need, the support that they are going to
need to get this money out, because it just has been very, very
difficult for a lot of poor people.
Secretary Becerra. Americans need heat in the winter, and
they need to be cool in the summer. And we will do everything.
We have expanded LIHEAP. We will do everything we can, Senator,
working with you and others to make sure that the resources
that you all provided get to people who need it.
Senator Manchin. I think basically just accept--helping
them with their application approval process. That will help
tremendously, if you can look into that. The other thing is
that I had one thing that I wanted to mention to you, and I
think we have talked about before, I have been trying to
support and trying to pass the Lifeboat Act.
And only thing it does, Lifeboat truly is saying that we
are going to charge manufacturing of opiates one penny per
milligram. That one penny per milligram goes to treatment
centers all over America. Every one of us in our States have an
addiction problem. But we have so few facilities, and the
Government can only do so much. But I think the manufacturing
that is a manufacturing fee, it won't be passed on as far as
cost to the consumer.
But for--if you are going to put this product on the
market, you ought to know the damage it does. And right now, we
see lawsuits all over the country. I would hope you are looking
into that and see if it is something you all could support. It
is not onerous at all. It basically directs every penny to
treatment centers.
And the final thing I want to ask you about, the $10
billion that we are stuck on, I cannot believe it. What is it
going to do? What risk are we really going to be faced if we
don't get this funding?
Secretary Becerra. Well, the $10 billion is certainly not
enough to carry us to the end of the fiscal year. But what it
does do is it lets us stay at the front of the line to make
sure we are purchasing the medicines, the treatments, and the
vaccines that we need moving forward. Without that, again, we
could lose our place in line.
COVID-19
Senator Manchin. This is like the different variants, that
first of all, we thought COVID-19 was over. Then we have been
told, Dr. Fauci told us, that there are going to be different
variations. And it is exactly true what he said. And now we
even have more. But what is the time element? Where are you
going to be crunched on if politics is being played? Democrats
and Republicans got to come together for the health of all
Americans.
Secretary Becerra. Our scientists are telling us that in
the fall, winter, we probably will see another surge. How big,
who knows. But in order to be ready for that fall or winter, we
have got to start purchasing today, not in the fall or winter.
Senator Manchin. I just, I know you all have a yeoman's
task in front of you, and I appreciate the job you are doing.
And I just want make sure that we can help you and assist in
any way possible. So communications between the offices have
been great and I appreciate that. We need a lot more and we are
going to try to do all we can to make sure we can protect
Americans.
Secretary Becerra. Thanks, Senator.
Senator Manchin. Thank you. Thank you.
Senator Murray. Thank you. Senator Hyde-Smith.
Senator Hyde-Smith. Thank you, Chairwoman Murray and
Ranking Member Blunt, for holding this hearing today. And I
also want to thank the Secretary for being here and your
willingness to serve and your willingness to answer these
questions. On March 11, 2021, President Biden signed the
American Rescue Plan Act of 2021 into law. Out of the nearly $2
trillion in this bill, only 6 percent went to vaccines and
public health.
Despite the fact that a lot of ARPA funding has yet to be
disbursed, the Biden Administration continues to press Congress
for more money. Over the past few months, your Department in
particular has asked Congress for more funding to ensure
continuation of critical aspects of the U.S. healthcare
response to COVID-19.
Knowing that there would be a continued need for pandemic
related healthcare, why did HHS divert healthcare related funds
toward the care of illegal immigrants who were coming here due
to the Biden Administration's open borders policy?
Secretary Becerra. Senator, thank you for the question. And
as you recall, in the midst of the American Rescue Plan,
America was sinking and the rescue plan was to do more than
just the healthcare side, it was to make sure that those
families who had lost their jobs, those business owners who
were losing their businesses, could survive the pandemic. And
so that is why so many of the resources went to keep America
afloat. And today we see that very few Americans are
unemployed.
The economy is moving. But I get--to your point on the
resources, we used resources to deal with COVID in its many
different facets, including at the border. And so when it came
to those migrant children, we wanted to make sure that everyone
was safe, including those children.
So we used some of the COVID money to make sure for COVID
related reasons, we kept America safe and including those
children safe from any particular spread. And so we documented
the spending on those programs to Congress, and we continue to
show that the success of keeping COVID from spreading,
including on the border, was not only important, but kept our
economy moving.
Senator Hyde-Smith. I am well aware of the need for that
funding and all the American children that needed the vaccines
as well. Knowing these healthcare needs exist, why isn't your
Department working with the Office of Management and Budget to
shift undisbursed funds toward the healthcare priorities before
asking for more money?
COVID-19
Secretary Becerra. Senator, we are more than willing to go
through with you and your team the way we have used the money.
We have allocated all the dollars we have, the discretion to
move towards the task of dealing with unaccompanied children or
dealing specifically with COVID, but we are more than willing
to get into some of the specific if you would like to see how
we have been able to use the resources you provided.
Senator Hyde-Smith. And staying on the topic of COVID-19,
this is incredibly important to me. I have been in touch with
your Department for months on behalf of a gentleman by the name
of Cody Flint in Mississippi. He is an agricultural pilot in
Mississippi. Cody received his first dose of the Pfizer vaccine
on February the 1st, 2021, and immediately began experiencing
very adverse side effects, such as headaches, vision, and
hearing issues, dizziness, loss of balance, and a lot of pain.
COUNTERMEASURES INJURY COMPENSATION PROGRAM
Due to these serious health issues, he has not been able to
fly as an Ag (Agricultural) pilot since receiving the COVID
vaccine shot, rendering Cody unable to provide for his family
as an Ag pilot in Mississippi. For more than a year, Mr. Flint
has been painstakingly going through the Countermeasures Injury
Compensation Program, seeking compensation he may be entitled
to based on his experience.
I have worked with him to try to navigate this process. And
I have been stunned not only by your agency's lack of urgency
in refusing such claims, many claims, but also the lack of the
transparency in that process. I certainly still advocate for
the vaccine, and I myself received the vaccine, and I encourage
others to speak to their doctors about receiving it, however,
as with any new medical product, some people will have side
effects.
The CICP (Countermeasures Injury Compensation Program)
exists for that very reason, and I am very concerned about the
amount of time it takes your agency to process claims and the
lack of clarity given to those folks who were adversely
affected. Can you tell me what you are going to do to address
the thousands of claims currently in backlog at HHS?
And what are you doing to improve the transparency of the
CICP process so that Americans like Mr. Flint are properly
compensated in a reasonable time period?
Secretary Becerra. Senator, well, you have asked a very
important question not just to Mr. Flint, but to so many
Americans who did what they should, which is to get vaccinated.
We are finding that there are a number of Americans who are
suffering from what we are calling today long COVID, and we are
doing everything we can to make sure we provide them with the
support that they need to get through this, who knows how long
it may be. We are doing research on this as well.
I will say this, transparency is important. Accountability
is important. And we want to make sure that those who really do
have a medical issue to report are the ones who are receiving
the assistance. We, as you are aware, in some cases, some of
the COVID money has been used fraudulently by many.
We want to make sure that no one is trying to game the
system to get relief for something that doesn't exist, that way
we can reserve the funds that we have for people like Mr. Flint
and provide him with some help.
And so why don't we do this? I am more than willing to have
my team reach out to you, and we can see about Mr. Flint and
where he is in his process, because we have heard this story on
many occasions. We know that millions have been saved because
of the vaccine, but we also know that many people are still
suffering, so we look forward to working with you.
Senator Hyde-Smith. He has totally lost his income and the
financial burden is just unbelievable, but the frustration of
trying to just get some answers of when something could be done
for him for this compensation has been very great. Thank you
for your help and for answering my questions.
Senator Murray. Thank you. Senator Reed.
LIHEAP
Senator Reed. Thank you very much, Madam Chairman. Let me
go back, Mr. Secretary, to an issue that Senator Manchin
raised, that is LIHEAP. I am pleased to say that the President
slightly increased LIHEAP in his budget this year, but the
reality is that energy prices are just exploding. In the past
12 months alone, the price of natural gas has increased by 22
percent and the price of heating oil has increased by 70
percent.
So would you support any type of supplemental funding to
enhance the LIHEAP so that we can deal with this extraordinary
increase in prices?
Secretary Becerra. Senator, we will support any effort to
try to further fund LIHEAP given the circumstances that we are
in.
Senator Reed. Thank you very much. Also, let me go back to
the point you raised, which I am pleased that you are moving
aggressively. That is the 9-8-8 number. We all understand that
we were in a mental health crisis in the country. I hear that
not only from my constituents, but as I visit troops around the
globe, I hear it from our military personnel also. And we just
had a terrible incident, you know, multiple suicides at one of
our Navy carriers. 9-8-8 is a great idea, I think.
NATIONAL SUICIDE PREVENTION LIFELINE
I had something to do with it and that is why I think that
way. But anyway, it is going to allow someone to call who has a
suicidal ideation and try to get help. But it has to be
implemented thoroughly throughout the Nation. In Rhode Island,
my State has done, I think, a very good job of setting up the
counseling centers, the technology, and etcetera. But as I
understand the system, if someone calls in and a State doesn't
have the infrastructure, they are referred someplace else.
So you have a not a very good relationship, long distance,
and also adding more work to States that have enough work
already. So can you give us sort of a sense of how the Nation
is doing and are we all going to come online together?
Secretary Becerra. Thank you, Senator. And I do believe
your State is doing very well in moving forward. We have a
patchwork right now of call centers that accept these calls
from folks who are suffering from mental stress. We are trying
to turn that into one cohesive network. It is difficult because
it won't be run by the Federal Government, it will be run by
the 50 States, the territories, and the Tribal governments.
But what we are doing is working with them with your
support. We have so far invested $300 million throughout the
country with all the States, local governments to try to make
it work. We will also provide back up call centers to make sure
that if any particular location is receiving a large volume of
calls, there will still be someone who answers the phone,
because the worst thing you can have when someone reaches out,
instead it goes in the wrong direction, is to get a busy signal
or be put on hold.
Senator Reed. No, I completely agree, Mr. Secretary. And,
you know, there are long term costs to not implementing
something properly. We understand that. And this is an
opportunity. We have to get it right. I also understand the
President has requested nearly $700 million in his budget for
the National Suicide Prevention Lifeline.
And I think you will need that money, but I think right now
we have a few months to get it right. And if you need
additional help or assistance, please let us know.
Secretary Becerra. Thank you. We are keeping tabs. We are
contacting every Governor of every State every month to let
them know where they stand.
Senator Reed. Well, thank you, Mr. Secretary. It was a
pleasure working with you in the House, and it is a pleasure
working with you in your capacity. Thank you.
Secretary Becerra. Thank you, Senator.
Senator Murray. Senator Moran.
ORGAN SHARING
Senator Moran. Chairwoman, thank you very much. Mr.
Secretary, good morning. Let me start with a topic that I asked
you about in your confirmation hearing or in our conversation
prior to your confirmation hearing, organ transplants. For over
30 years, HHS has contracted with United Network for Organ
Sharing, UNOS, yet it is currently under a Congressional
investigation by the Senate Finance Committee.
I would tell you my experience is their attitude approach
to their policy has been very discouraging and detrimental to
the lives and well-being of those individuals who are hoping to
be a recipient of an organ transplant. Damaging geographically
in their outlook and damaging geographically in their policy.
The contract that UNOS holds with HHS for organ procurement and
transplantation is up for competition in 2023.
A recently published request for information on the
contract, which I joined Senator Grassley and Senator Wyden and
Young in supporting--this RFI (request for information) is an
essential step to improving the Nation's organ transplant
network. Numerous reports have highlighted the best way to
increase competition for the contract is to divide it up.
I don't know whether that is the right answer or not, but I
would love to hear from you what specific steps--I want to know
that you are aware of these problems and what specific steps
you intend to take to increase competition for potential organ
procurement and transplant network contractors.
Secretary Becerra. Senator, this is an issue where you have
real people who come to you and tell you about their real life
circumstances. So we absolutely know about this. We are trying
to prepare to make sure that in the process of coming up with
these new contracts, we increase supply, not diminish supply,
that we make it a more fair distribution of these organs and
that we make it more transparent.
And that is in the works. And what I offer to you, because
I think it is so important across the country, we will work
with you if you and your team have any particular ideas, if we
haven't already incorporated them. I am more than willing to
make sure we take that into consideration.
Senator Moran. If you would give me a name of a contact,
you give my staff a name of a contact today, we would be glad
to follow up. I would love for your team to hear from not only
me, but from those who are actively engaged in trying to make
the system work better.
Secretary Becerra. I will follow up with you at the end of
the hearing. Whether we meet directly or through our staffs, I
will make sure that happens.
THE NATIONAL STRATEGIC STOCKPILE
Senator Moran. Xavier, thank you very much. Let me
highlight a couple of other things. The National Strategic
Stockpile, Strategic National Stockpile, you request, the
budget requests $975 million for the national stockpile for
fiscal year 2023. Ensuring that--and I raised this topic in the
authorizing committee, and I want to make sure that it is not
lost between the two committees. I serve on both of them.
But ensuring that the SNS (Strategic National Stockpile) is
restocked and maintained to its maximum capacity is important.
I think it became more important with Russia's invasion of
Ukraine, and I would ask your commitment to prioritizing fully
stockpiling the biodefense and pandemic response supplies
maintained by the SNS.
Secretary Becerra. You have got my commitment, and I hope
you will take a look at the President's pandemic preparedness
plan moving forward. I think you will like what you see.
PROVIDER RELIEF FUND
Senator Moran. Thank you very much. And I will do that.
Rock Regional Medical Center is a new hospital in the suburbs
of Wichita. We have been, me and my office have been working
with the Health Resources and Services Administration for the
past year flagging Rock Regional, which did not receive a fair
allocation of provider relief funding.
It is a new hospital and was treated in a way that--it
seemed to me that HRSA (Health Resources and Services
Administration) seemed uncaring about solving this problem, and
it is not the only hospital in which that is the circumstance.
And I don't think I am the only member of the Senate who
believes that. So why is HRSA so unwilling to reconsider their
methodology for PRF (Provider Relief Fund) funding for new
hospitals?
Secretary Becerra. Senator, you are absolutely correct. You
are not the first and Rock Creek is not the only facility. Here
is the difficulty. All those funds that were dispersed before
2021 were done under a formula that we could not change. That
formula, to your point, relied on looking at past performance.
If you are a new hospital, it is hard to talk about your past
performance.
That did damage a lot of these facilities that were newer.
The difficulty, as you will understand, is we could not change
the statutory framework of the provider relief fund and the
distribution. To undo that would have meant to have to pull
back all the funds. What we did do was we changed the formula
with the tranches of dollars that was still existed that we
could move forward with.
But we are more than willing to work with you and those
providers in your State so we can try to address some of that.
But it is tough because we can't undo what was previously used.
Senator Moran. You described it--I am always pleased when
an administration official of any administration says they want
to follow the Congressional law. That is pleasing to me. It is
not always the case that I find it to be the case that it
happens. But I would indicate that we thought this could be
better addressed in the later phases, and our conclusion was
that it was not. So I would be glad if you will, again, help me
get again to somebody who can address this issue.
Secretary Becerra. And if you will permit me a quick
response, it is not that we don't want to, it is just that what
was left with the final phases was so little, and there were
still so many new incoming requests and some facilities that
had gotten no money whatsoever. For example, nursing homes had
been left out in the first tranches. So it is not that we
didn't want to go back. It is that with what was left, we
couldn't try to undo the formula requirements of the previous
Administration.
Senator Moran. Thank you for your explanation.
Senator Baldwin [presiding]. I will now recognize myself
for 5 minutes of questions. Secretary Becerra, thank you so
much for appearing here today. I am, as are you, prepared to
talk about the fiscal year 2023 budget, but I did want to
acknowledge what we saw from the Supreme Court on Monday night.
If the court is really going to legislate from the bench and
turn back the clock 50 years on Roe v. Wade, then I think the
Senate needs to pass the Women's Health Protection Act, an act
that I have co-led with Senator Blumenthal.
And frankly, I would say that if we need to eliminate the
filibuster to get it done, that is what we should do. And I
encourage strongly my colleagues to support that effort. Now,
the Biden Administration has worked to expand access to
comprehensive, affordable coverage through the Affordable Care
Act.
INSURANCE PLANS
And I support these efforts. But unfortunately, we continue
to wait for the Administration to address the issue of junk
insurance plans. I wanted to share the story of Phillip from
Janesville, Wisconsin. He received a $34,000 bill for an
emergency room visit and an overnight stay at an area hospital.
Rather than paying the bill, his junk insurance plan rescinded
coverage due to an alleged preexisting condition. When Phillip
wrote to my office, he said he wanted to warn people about the
dangers of these plans.
And he shouldn't have to do that. So, Secretary Becerra,
during the hearing to consider last year's budget request, I
asked why the Administration hadn't yet taken action to address
these junk insurance plans. It has been a year. Can you tell me
when the Administration will take action to address these
plans?
Secretary Becerra. Senator, absolutely an appropriate
question. And we are in the midst of rulemaking. As you know,
rulemaking could take a little while, but we started that
process because of what you have explained. It does happen.
Junk plans are leaving Americans with these tremendously
expensive bills.
Fortunately, with your help, the No Surprises Act is now
law. And so individuals who get these surprise bills will no
longer have to worry about paying such exorbitant bills. We
hope that what we find is between the No Surprises Act statute
and are changed to try to undo these junk insurance plans--that
we will provide Americans the protections they thought they
had.
NATIONAL SUICIDE PREVENTION LIFELINE
Senator Baldwin. Yes. Well, please keep me apprised of the
timeline. We are very anxious to see this addressed in
rulemaking. I know that you were just asked some questions
about the 9-8-8 Suicide Prevention and Lifeline Hotline.
I want to just add that I was very proud to be the co-lead
on the 9-8-8 bill and very supportive of the additional funding
in the budget to prepare the States to make this line live. I
still, though, hear from leaders in Wisconsin who are concerned
that our State may not be fully prepared for the 9-8-8
transition.
So can you tell me a little bit more about the guidance
that the Department is giving to States when it comes to
securing the additional funding? And do we need to take more
action to make sure that there is adequate preparation in the
States for this transition?
Secretary Becerra. Senator, the most important thing you
can do is to continue to advocate that your State build the
capacity to handle its 9-8-8 response. There are several States
that have. We are working with every State with the resources
you have made available to us to work with States, the
territories, and the Tribal governments.
But without the States taking control of this, it will be
very difficult to believe that they will be able to manage the
calls that they will get. And the last thing any of us want is
for someone who is reaching out at a time of pain to not have a
real person respond.
Senator Baldwin. Can you, as a follow up, make me aware of
the interactions that you have had with Wisconsin? It is
troubling to hear these concerns raised by mental health
leaders. And I want to make sure that our State is accessing
the Federal funding that is available.
Secretary Becerra. Senator, I can make sure we give you a
copy of the letter we sent to every Governor, in this case,
your Governor, to let them know where they stand in
implementation.
Senator Baldwin. I see I have run over my time. We might
start a second round of questioning now, and I will call on
Senator Blunt for a second round.
Senator Blunt. Thank you, Senator. Let's talk about mental
health for just a little bit. I was pleased in the budget that
you have shown--asked for a substantial increase in the
certified community behavioral health clinics, allowing them to
continue to treat mental health like all other health, and also
making the current demonstration program permanent and allowing
all the States and territories to participate.
So I am pleased to see that. I look forward to seeing how
far we can go to create a reality of that request. One thing I
did want to talk to you about with the mental health agency,
SAMHSA. The budget was released on March 29. Three weeks later,
we got the first of two notices of a fairly substantial
reorganization, three reorganizations. One established a new
Office of Recovery within the Office of the Assistant
Secretary.
Another created an Office of 9-8-8, which is the suicide
helpline number, Behavioral Health Crisis Coordination. A third
established a new program of prevention initiative. I have
several concerns here. One is, there is nothing in the budget
that reflects these agencies being there or so far no direction
as to where money should come from to fund them.
Two, I think some of the prevention efforts have become
more harm reduction efforts than I think that Congress would
have intended for, or certainly that I would intend for. And
three, there are even press reports that the Administration is
thinking about safe injection sites under the guise of
prevention, even though I believe those sites are against the
law.
Now, we did have an update just yesterday, the first update
of our staff of what that Office of Prevention might do. And we
asked about some of these controversial things. I think we are
not at all sure yet that there is enough information out there
to not be concerned about this or not stay fully engaged.
One, why would we get that kind of reorganization 3 weeks
and only 3 weeks after the budget was submitted? And two, how
do you expect us to incorporate this into the budget that you
have already asked for?
Secretary Becerra. Senator, thanks for the chance to
respond. And as I mentioned to you previously in a
conversation, we would reach out to your team. We have reached
out to your team. Let me tell you what my team is explaining to
me. First, the reorganization does not impact the budget. We
are going to work with the monies that we have.
We don't need new authorities because what we are simply
doing is reflecting the President's priority on behavioral
health, to really tackle this, and also to focus on trying to
have a new strategy on drug use. And so what these offices are
doing is essentially consolidating what exists in our agencies
to really focus in more directly on these very important
subjects.
And so what we could do is we will follow up again with
your team to give you details. As I said, it doesn't impact the
budget. And what we can do is explain how the reorganization
helps us achieve the President's desire to really tackle mental
health and drug use as directly as we can. We established, for
example, a coordinating council among all of HHS's agency so
that we wouldn't wait to learn what each other is doing.
SAMHSA and the Office of Public Health are coordinating
that. So we are working immediately to deal with mental health,
and so we are going to do more of that so we can make the best
use of our money. But we will follow up.
Senator Blunt. Well, we need you to do that. And it will
impact the budget to the extent that we need to know where that
funding comes from and what new authority--new line items,
lines need to be created for that reorganization if there need
to be new items. And we look forward to continuing to work with
you on that.
Secretary Becerra. Thank you.
Senator Blunt. Thank you, Chair.
Senator Murray [presiding]. Thank you. Senator Baldwin.
PERSONAL PROTECTIVE EQUIPMENT
Senator Baldwin. Thank you. So I am thinking back to the
first months of our struggles with the COVID-19 pandemic and
all of the work we were doing with first responders and
hospitals and others to secure PPE (Personal Protective
Equipment).
And in particular, respirator, N95 masks were in
desperately short supply. And at that time, American companies
began stepping up and they retooled manufacturing lines to help
compensate for these weaknesses in the supply chain when there
was a global demand.
And working around the clock, they met the need for
essential products, including N95 respirator masks and other
PPE. These companies helped save lives, and now they are in
trouble. I wrote to President Biden earlier this year urging
him to prioritize long term contracts for the purchase of masks
made by American workers in American factories with American
materials.
So I wonder, Secretary Becerra, as Health and Human
Services works to replenish the Strategic National Stockpile,
can you commit to prioritizing American made PPE?
Secretary Becerra. Senator, absolutely. That is what we
have done. As I mentioned earlier, we made it possible to
actually have tests that were manufactured here. But to keep
those lines of production going domestically, we have to be
able to commit now, otherwise they are going to start to phase
those lines down and it would take months for them to try to
ratchet back up, which could cause us to have to go to foreign
sources for that supply of tests or masks.
Senator Baldwin. Are you procuring American made N95 masks
right now for the national stockpile? Have you been?
Secretary Becerra. We--and I will get back to you on
exactly how much of that might be domestic production. But you
will recall that we put out about 270 million N95 masks to
Americans free of charge to help people deal with COVID the
pandemic. We are resupplying the stockpile, and we are doing
everything we can to make sure that when we do resupply, it is
with domestic manufactured product.
Senator Baldwin. Okay. Thank you.
Senator Murray. Senator Braun.
GENDER AFFIRMING CARE
Senator Braun. Thank you, Madam Chair. So when we have had
an opportunity to talk, you know, early on I have been a
proponent of reforming healthcare by making it more
transparent, more competitive. I think that has largely been
lost in all the other issues that have come up. Still
interested in that. But the subject that is really creating
controversy across the country would be gender affirming care
for young people, and it is on the HHS website.
I would like to work through what gender affirming care
actually means and do it with a couple of subjects in mind,
drugs and surgeries. Let's start with prescription drugs. I
don't think these drugs have been proven safe and effective for
the use you are recommending. That is probably why the FDA has
not approved puberty blocking and hormone therapy drugs for
gender transition.
Any time a physician, you know, prescribes it, they are
doing it off label. Would you agree that off label
prescriptions for usages not approved by the FDA are
potentially dangerous for patients, especially kids?
Secretary Becerra. Senator, thank you for the question. And
that is a question that HHS, including FDA, CDC, have been
tackling quite a bit as a result of the pandemic. What I would
simply say to you is that the FDA would raise alarms if they
saw that a particular medicine or a treatment were being
misused.
And at this stage, what we know is that for a drug to be
out there available, it has to be safe and effective as FDA has
found it. So, what I would simply say with regard to this
particular subject is, when individuals go in for care, it is
their physician who is making that decision with them about
what type of medicine or treatment they should receive.
Senator Braun. You know, if you use that same logic on what
we have just navigated through COVID, it seems like there would
have been a different point of view. And to me, for many
parents across the country, this has more potentially tragic
consequences and it seems like it is a double standard.
Let's look at surgeries that would be even more impactful.
And I am not going to mention the particulars there. It is
almost grotesque to mention what could occur. Could you explain
what irreversible top and bottom sex change surgeries are and
why that is on the portal as well?
Secretary Becerra. Senator as you have just indicated,
there are many different types of procedures that can be
deployed. What I will say to you is, again, in any case, no
individual, no patient will proceed forward unless his or her
doctor has advised of the procedure. And it is considered by
the FDA and others who have to go ahead and certify a medicine
or a procedure to be safe and effective.
Senator Braun. So I will try to distill it into a more
simple form. In what case would it be appropriate to perform
irreversible sex change surgery on kids?
Secretary Becerra. Those decisions are made by that
individual in consultation with physician and caregivers, and
no decision would be made without having consulted
appropriately.
Senator Braun. You know, I think the Government shouldn't
be pushing or have it out there on a portal that moves you
towards irreversible sex change therapy. And I think we just
need to think about it carefully because we are navigating into
territory that we have never done before as a government.
Kids going through this are having a hard time. We should
be maybe focusing more on mental health and not things that are
irreversible. And I think leading the HHS, it might be a little
more important to be a little more definitive rather than
making it look like, well, a laissez faire approach and
whatever happens, happens. I think that is out of sync with
most of America. And it seems to me it would be wise to maybe
back up a little bit.
Secretary Becerra. Senator, I hear what you are saying. I
believe that we should help those have the life affirming care
that they need. There are many transgender youth who have
actually gone in the opposite direction, taking their life. If
we can make a life better for someone in America, we should,
especially if, in consultation with their physician, they
approve of those procedures.
Senator Braun. You think it would be reasonable, my last
question, in the meantime to maybe take this off the site until
there is a little more kind of science built into the approach,
a little more discussion about what may or may not make sense,
rather than having an out there where it looks like it condones
the process?
Secretary Becerra. I would say to you that many of our
medical experts would tell you that we have explored this
subject for a long time, and what we find is that we are
helping improve the lives of many Americans by providing them
with the care that they have chosen, with the informed consent
of family, and also with the consent and advice of their own
physician.
Senator Braun. Thank you.
Senator Murray. Thank you. Senator Shaheen.
WOMEN'S HEALTHCARE
Senator Shaheen. Thank you, Madam Chairman. And thank you,
Mr. Secretary, for being here this morning and for the work
that you and everyone at the Department of Health and Human
Services does to promote the healthcare of the people of this
country.
I was stunned, as I am sure all of us were, by the news on
Monday when we saw the draft opinion leaked from the Supreme
Court that proposed eliminating access to safe and legal
abortions for women and for healthcare that goes along with
that. I think it is stunning. And this is a statistic that I
found incomprehensible, that the United States could become one
of only 25 countries in the world that would totally ban
abortion.
And if this decision is correct and this is what the court
decides, it would leave up to the States decisions about
women's reproductive freedom that presents challenges in States
like mine, New Hampshire, where we have seen funding denied to
family planning centers on the front lines of these efforts,
even though it is funding that does not support performing
abortions.
TITLE X
But these family planning centers provide healthcare to
thousands of women in New Hampshire. We appreciated your visit
to see how Title X is working to keep doors open for family
planning services for thousands of women in the Granite State.
So I am very concerned about what is going to happen.
And I wonder if you could update us on the work of Health
and Human Services Reproductive Health Care Access Task Force?
Secretary Becerra. Senator, thank you very much. We are
going to double down on the effort to make sure that the legal
rights of all Americans, women, to access the care that they
are entitled to continue forward.
Yesterday I had an opportunity to address a number of the
representatives of many of the insurance plans, health
insurance plans in America, and made it very clear that we
intend to continue to enforce the law. We have heard complaints
that some women are not being provided with access to the care
that they are entitled to through their insurance plans.
We will continue to do that. We will continue to support
the efforts of family planning efforts that are available
through Title X. We will also make it clear what the law
requires of anyone who accepts Federal funding through
Medicare, Medicaid to provide services to all Americans without
discrimination.
As I said, we are going to double down to make sure that no
one goes without the care that they are entitled to.
STATE OPIOID RESPONSE GRANTS
Senator Shaheen. Thank you very much. I appreciate that.
Another crisis that New Hampshire and so many other States in
the country are dealing with is substance use disorder
epidemic. And we have seen how the COVID pandemic has
exacerbated that. In New Hampshire, we are still in the middle
of this crisis, and the State opioid response grants have
really been a vital source of funding for our State to provide
treatment that people need.
So as you work to administer those grants this year, will
you commit to working with me and with other members of New
Hampshire's delegation to ensure that changes in a State's
ranking in opioid overdose deaths don't result in large scale
reductions in funding.
One of the things that I am--I should preface that with
saying, one of the things that we have seen in New Hampshire is
that our overdose deaths have leveled out to some extent
because we have gotten so good at using Narcan and providing
Narcan to local police departments and firefighters so that
they can respond when someone has overdosed, but that doesn't
mean the underlying problem isn't there.
Secretary Becerra. Senator, first, thank you for keeping
this issue of the SOR (State Opioid Response) grants top of
mind to make sure that no State, no community suffers a cliff
in the funding that they need to continue to provide service to
those who are suffering from drug use. We will continue to work
with you.
We have provided additional resources. The budget proposes
$475 million above the previous fiscal Year because we
understand how important it is. But I have no doubt that you
will continue to insist that we do this the right way and that
no one loses the funding they need.
AFFORDABLE CARE ACT PREMIUM RELIEF
Senator Shaheen. Well, thank you. I know that is of
interest to others on this subcommittee. So thank you very
much. A final question has to do with the Affordable Care Act
premium relief, which one of the very positive aspects of the
American Rescue Plan was the Act's premium tax credits that
extend for 2 years to help provide coverage for people who
can't afford the cost of healthcare.
Those provisions are set to expire at the end of this year.
Can you talk about what the plans are to ensure that we don't
see a number of people kicked off of the Affordable Care Act
insurance because those premium tax credits are expiring?
Secretary Becerra. Senator, thank you for what you and your
colleagues did to make that possible. As a result, today, more
Americans have access to healthcare, they have insurance,
health insurance, than at any point in our country's history, a
greater number. And part of that is the 14.5 million Americans
who receive their coverage through the Affordable Care Act
marketplace.
That came because you made it possible for us to avoid the,
again, the cliff that some families faced when it came to the
cost of coverage by providing those subsidies and made it very
affordable. And in some cases for some families so affordable
that they were finding that they were paying $10 or less per
month for their monthly premiums.
And as I always try to say, go try to see a movie in
America for less than $10 a month, for one movie, not for a
whole month. And so we will continue to work with you, because
it has clearly proven itself successful to make sure Americans
can afford to have their health insurance coverage.
Senator Shaheen. Can I just ask one follow up----?
Senator Murray. Yes----
Senator Shaheen [continuing]. Madam Chair. So when you say
you will continue to work with us, should we expect a proposal
coming from the Administration to extend those premium tax
credits or to look at other ways to provide help to people who
need help with the cost of health insurance?
Secretary Becerra. The President has made it very clear, we
want to see those premium tax credits extended. In the
President's proposals, Build Back Better proposals, and others,
we have talked about how we continue to expand access to
healthcare and reduce costs, and we will continue to work with
you.
Senator Shaheen. Thank you. Thank you, Madam Chair.
Senator Murray. Senator Moran.
NATIONAL SUICIDE PREVENTION LIFELINE
Senator Moran. Thank you, Chairman. Mr. Secretary, in the
time that I have been here, you have been asked a number of
times about 9-8-8. Let me just ask a specific question about
your plans.
Would you fill in the details on the $700 million request
for the National Suicide Prevention Hotline with the
opportunity to explain the reasoning behind that amount and
what it would be used for?
Secretary Becerra. Senator, thank you. We are finding that
because we have had this patchwork, as I have mentioned before,
of response and we are trying to make it into one unified
response--so if you today are in D.C. and you are feeling
stressed, but then you travel into Maryland or West Virginia,
you don't find that you lose the same access to services that
you might have had if you were in one of those different
locations.
To make that happen so it is seamless, requires a great
deal of support because the States are accustomed to dealing
only with the folks in their communities. We are trying to make
it so that there are--it makes no difference. If you have an
area code phone from the State of Kansas, but you happen to
find yourself in my State of California, you are still going to
get response regardless of where you are. That requires
resources. Some States have moved to actually provide a
permanent line of funding for their 9-8-8 services.
Others have not. We don't want to see anyone fall through
the cracks. And so we are working hard to provide them with
services. We put in over $300 million in this current fiscal
year. The President is requesting more because we know it is
not just a matter of making sure that the system works, but
moving forward, we want to make sure that the follow up
services are available so that you don't just get a voice that
says we are here to help, but that the services will be there
to follow within the States.
Senator Moran. So is the $700 million utilized for the
technology of the phone call? Or in providing actual services
once you get somebody on the line?
Secretary Becerra. More for the services. So for example,
many States are not able to handle the call volume they get. We
want to make sure that regardless of where you are, even if a
State is receiving a high volume or exceeds its capacity, that
that call will still get answered. So we have backup call
centers that are set up.
That is something that we are really supporting because
States, if they don't have enough in their own State, are
probably not prepared to fund a callback--or call capacity. So
we are trying to make sure we have those fallback centers in
place.
Senator Moran. Excuse my obtuseness, but that sounds to me
as if that is the technology of the phone call, the access to
reaching somebody, not--that is not money to provide the
psychologist to talk to or the mental health counselor on the
other end of the line?
Secretary Becerra. The technology isn't that difficult. We
are actually working with the FCC (Federal Communications
Commission) right now to try to make sure that those calls can
be connected regardless of where the individual is and who the
responder will be.
So we are going through those technical aspects, but the
resources are to make sure there is actually a professional, a
health professional who will be available to answer those
calls. Some States, as I said, are more prepared than others.
That shouldn't be a reason why an individual who is crying out
for help doesn't get support.
Senator Moran. Secretary, so if a State is lax in their
implementation of this legislation, there will be a Federal
response to the phone call from that State?
Secretary Becerra. Well, that is the thing. We don't--you
all did not give us the resources or the authority to
essentially run the whole lifeline. But what you did give us
was the capacity to help States lift up their capacity. And so
we are working very hard right now and for the immediate future
to make sure that July 16, if someone calls 9-8-8, they get a
response.
Some States will be better prepared July 16 than others.
The funding that we are requesting lets us get everybody up to
speed.
Senator Moran. I think the way I would say what you are
saying is they get a response, and the response is more than
someone saying, hello.
Secretary Becerra. Yes.
Senator Moran. It is the follow on to that.
Secretary Becerra. So crucial. So crucial.
Senator Moran. Okay. Thank you. I was one of the original
sponsors of this bill. I am trying to see and figure out how--I
guess what you are describing is that the legislation, it
provides what you are supposed to do, and you are trying to do
it.
Secretary Becerra. Yes. And we can provide you with an
update on where Kansas is because we are providing every
Governor with an update every month of where they stand so they
are aware of what they need to do or how well they have done.
Senator Moran. Okay. Thank you, Madam Chairman.
OPIOID CRISIS
Senator Murray. Thank you. Secretary Becerra, I want to go
back to a topic that Senator Shaheen mentioned, and that is
that our communities are really being hammered by the opioid
crisis. Just last year, more than 105,000 Americans died from a
drug overdose. In Washington State, synthetic opioid use is up
drastically.
Overdose deaths are now up 66 percent since 2019, and over
half of those are attributable to fentanyl. This is just
unacceptable. We really need some urgent action from the
Administration. Can you talk to us about what your plan is to
stop the harm being caused by opioids, especially fentanyl?
Secretary Becerra. Madam Chair, in response to some of
Senator Blunt's questions, I mentioned that we have reorganized
within HHS to make it a priority to address drug use and
address the disorder that is there, especially with opioid.
So we have come up with a different strategy where we
forget about the stigma, we forget about the old way of doing
it. And our strategy now not only relies on prevention and
treatment, but on harm reduction and follow up services so that
we don't let people regress.
And so what we are doing right now is working with local
communities, because we don't do it at the Federal level, we
work with local communities, with the resources you all are
giving us to help beef up their capacity to provide not just
testing and treatment, but also to help them with harm
reduction.
Senator Murray. Well, I am especially alarmed by the rise
in overdose deaths among adolescents. Fatal overdoses among
youth nearly doubled in 2020 and have continued to rise since
then, which appears to be driven by these counterfeit pills
that are laced with fentanyl.
Parents in my State want to know, what is the Biden
Administration doing to protect our kids and prevent young
people from seeking out illicit drugs and make life saving
overdose reversal drugs more available?
Secretary Becerra. Well, Senator, we broke through that
ceiling that existed that prevented us from supporting local
successful operations that, for example, let someone know if
the drug they were about to take was laced with fentanyl.
The bugaboo back then, the stigma was, oh, you are helping
someone take drugs. We would rather save a life than judge that
person who is about to take a drug because they will take the
drug, whether we try to help them or not.
And so today, the Federal Government will support those
local programs that are, for example, providing fentanyl strips
to people so they can test that drug that they may be about to
use to find out if it is going to have a harmful----
Senator Murray. Does that help adolescents?
Secretary Becerra. That would help anyone who comes in and
who has access to that service from that local provider.
Senator Murray. And kids would seek that out?
Secretary Becerra. Madam Chair, there is--everyone, every
walk of life, every age as well, who is coming to some of these
centers. And some of these kids may require some adult
authorization in order to take certain treatments, but fentanyl
strips are available for those who are about to inject
themselves or use a drug that is--could likely kill them.
Senator Murray. And kids know about this?
Secretary Becerra. I suspect many adolescents are aware of
some of the local anti-drug programs that are available. I
can't tell you I know if they make use of them directly or not.
And I can't tell you what every State has in terms of laws and
making some of these services available to those who are
adolescents. But I do know that those programs are made
available to those who have drug issues.
Senator Murray. Okay. Well, let me just change the topic a
little bit. The pandemic, as you know, has been really hard on
our kids and it has turned their lives upside down. They have
lost time at school, time with their friends.
Some have lost loved ones and they are dealing with a lot
of stress and anxiety and trauma, and they really need our
help. But even before the pandemic, I was hearing from parents
who are frustrated by how hard it is to find mental health
services for their kids.
The President's budget would invest heavily in crisis care
systems, which I agree are important to handle emergency
situations and prevent tragic outcomes. But let me be clear,
children should not have to wait until their mental health hits
this crisis point to be able to get care. Parents are really
desperate to get help for their children here.
How would this budget, particularly your proposal, allowing
States to use 10 percent of their mental health block grant
funding for prevention and early intervention programs help
with that?
Secretary Becerra. Madam Chair, let me point out one
particular program that I know you and Senator Blunt have
worked hard on over the course of some time, and that is a
certified community behavioral health clinics and how we are
planning to expand access to those.
We provide about a quarter of a billion dollars for the
expansion of those services because we know that locally in the
community, if a family, if a young person has access to those
services, we get to them a lot sooner and perhaps save a life.
And so we are going to try to expand that.
The $51.7 billion, 10 year investment that the President is
making in mental health services is transformative. If you all
pass that in the President's budget, we will be able to do far
more in reaching these families because too many, as you said,
don't have the access they need.
Senator Murray. Okay. Thank you very much. That will end
our hearing today. And I want to thank my fellow committee
members and Secretary Becerra for a very thoughtful discussion
about how we can do more to support our communities, and keep
people safe and healthy, and address the challenges we hear
about from back home.
ADDITIONAL COMMITTEE QUESTIONS
For any Senators who wish to ask additional questions,
questions for the record will be due May 13 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 Secretary Xavier Becerra\1\
Questions Submitted by Senator Patty Murray
Question. The fiscal year 2023 President's Budget includes $400
million for the Title X--Family Planning program, which provides birth
control, cancer screening, and other lifesaving care. Unfortunately,
HHS approved but had to turn away dozens of highly qualified applicants
in March as a result of the flat funding in fiscal year 2022.
---------------------------------------------------------------------------
\1\ Responses are current as of the date of the hearing.
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What does that mean for patients? How many women will not have
access to life-saving healthcare services this year as a result of flat
funding?
Answer. Title X has not received an increase in service delivery
funding in the annual appropriations in 8 years. In total, we received
more than $420 million in requests for the $256 million that was
published available, meaning that approximately $165 million in
requests went unfunded. Due to internal budget adjustments, an
additional $3 million was used to award grants. It means that there
remains a high need for Title X reproductive health services needed
across the nation.
Question. How would HHS use the proposed increase for next year to
expand access for women of color and low-income women?
Answer. In fiscal year 2022, all new Title X grantees were awarded
at a 20-40 percent reduction of their requested amount, which reduced
the overall projected number of individuals that will be served in year
one. In many instances, that translated to significantly less than they
received in fiscal year 2021 because that funding has been redirected
to cover service areas that were entirely unfunded. Also, existing
Title X grantees that were approved in the grant review but not funded
were awarded funds for 1 year to help them serve and transition their
clients to other locations as they closed out their grants.
If $400 million were allocated to the Title X program in fiscal
year 2023, all of the Title X service grantees would be funded at their
original requested amounts. Additionally, those Title X approved but
not funded grantees would be fully funded for another year. As a
result, approximately 3.5 million clients would be served.
Question. The fiscal year 2023 President's Budget request includes
$975 million, an increase of $130 million, for the Strategic National
Stockpile. The request states that the SNS investments would ``make
meaningful investments across several portfolios necessary to ensure
readiness for future public health emergencies.'' Among such threats, I
remain concerned about the perennial danger of another influenza
pandemic, which infectious disease experts believe is not a matter of
``if'' but ``when.''
Do you share my concern about a flu pandemic, and would you support
the procurement of available medical countermeasures for the SNS to
prepare for this possibility?
Answer. The United States Government has and continues to support
preparedness for a flu pandemic. Influenza antivirals were originally
purchased by SNS using funds provided in 2005 under a pandemic
influenza supplemental. SNS has worked closely with the Food and Drug
Administration (FDA) to extend the expiration dates of many of the
influenza antivirals held by the SNS. The most recent extension of
expiration dates for influenza antivirals held by SNS was granted in
April 2022.
Question. The fiscal year 2023 President's Budget for Sexually
Transmitted Disease (STD) prevention is funded at the same level as
fiscal year 2022. These funds provide the bulk of the Federal dollars
going to State departments of public health to help prevent the spread
of STDs. Recently, the CDC has released data showing that STD rates
continue to climb and are at a 20-year high. The COVID-19 pandemic
likely contributed to the spread of STDs, since most of the health
departments across the country discontinued STD fieldwork because their
contact tracers were diverted to work on COVID-19.
What is your plan to ensure that when the next pandemic or other
public health crisis hits, we will have enough resources to address
both STDs and any new maladies that may be coming down the pike?
Answer. CDC's STD Program is utilizing the disease intervention
specialists (DIS) Workforce American Rescue Plan Act (ARPA) funding
(fiscal year 2021-fiscal year 2026) for COVID-19 and other infectious
diseases to directly fund DIS hiring, retention, and support by state
and local health departments; training and formal certification for
DIS; and providing DIS with critical tools such as diagnostic tests for
use in the field. CDC's STD Program will award a total of $1 billion to
state and local health departments from fiscal year 2021-fiscal year
2026. fiscal year 2021 and fiscal year 2022 funds ($200 million each
fiscal year) have been awarded through a supplement to CDC's
Strengthening STD Prevention and Control for Health Departments
cooperative agreement, which funds all 50 states and 9 local/
territorial health departments. These funds can be used to address the
existing emergencies of COVID-19, STDs, and HIV, as well as emerging
issues such as monkeypox or other public health crises.
Question. Given the dramatic rise in STDs, why did the Department
not ask for a more robust budget to combat STD rates?
Answer. The Administration, the Department and CDC must assess a
wide range of funding priorities when developing the President's Budget
request, within constrained resources. CDC is the only Federal agency
that directly supports and funds sexually transmitted infection
prevention and control activities of state, territorial, and local
health departments. STIs compromise Americans' health and cost
billions. To address the substantial increases in the rates of STIs,
CDC will continue to conduct STI surveillance and support states to
conduct STI prevention and control activities (e.g. contact tracing),
support training and educational materials for healthcare
professionals, and studies to translate STI research to practice and to
improve program delivery. CDC will also continue to support efforts in
alignment with the HHS STI Federal Action Plan and continue to bridge
implementation science, public health program management, and STI
prevention services that are high impact, scalable, cost-effective, and
sustainable.
Question. 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--and the horrifying
reality is that the vast majority of these deaths are preventable. And
Black women, Tribal women, and women who live in rural areas are at
much greater risk. I've been constantly pushing for more investments
here, and it's good to see this budget does the same. But we still
haven't managed to provide what's needed here.
What are the gaps in care that HHS won't be able to address this
year due to Congress' failure to fully fund your department's request.
Answer. The fiscal year 2023 President's Budget includes $164
million, an increase of $81 million over the fiscal year 2022 enacted
level, for the Safe Motherhood and Infant Health Activities at CDC. The
requested funding level included to expand the Enhancing Reviews and
Surveillance to Eliminate Maternal Mortality (ERASE MM) Program to all
50 states, Washington D.C., and territories for organizations
coordinating and managing Maternal Mortality Review Committees to
identify, review, and characterize maternal deaths and identify
prevention opportunities. With the lower funding level in the fiscal
year 22 omnibus, CDC will be able to fund 38 awards in 39 states which
falls short of a national ERASE MM program.
Wide disparities exist in maternal morbidity and mortality, with
racial and ethnic minority women and women in rural communities at
higher risk of pregnancy-associated death and complications. The trans-
NIH Implementing a Maternal health and Pregnancy Outcomes Vision for
Everyone (IMPROVE) Initiative, launched in 2020, supports research
focused on reducing preventable causes of maternal deaths and improving
health for women before, during, and after delivery. IMPROVE also
focuses on health disparities and populations disproportionately
affected (African American/Black women, American Indians/Alaska
Natives, Asian Pacific Islanders, Hispanics/Latinas, and people with
disabilities). One of the goals in fiscal year (FY) 2023 is to
establish a national network of Maternal Health Research Centers of
Excellence (COE). These COEs will conduct research to mitigate
preventable maternal mortality, decrease severe maternal morbidity, and
promote health equity by engaging communities, addressing health
disparities, and including communities that are maternity health
deserts.
The fiscal year 2023 budget request dedicates $276 million across
HRSA to improve maternal health; $202 million above fiscal year 2022
enacted funding levels. This includes funding for new and existing HRSA
programs that prioritize reducing maternal mortality and addressing the
disparity in maternal outcomes for women of color. The initiatives aim
to:
--Increase access to equitable, high quality maternity care services
for all pregnant and postpartum individuals;
--Expand and diversify the perinatal workforce; and
--Support strategies that impact maternal health where women live,
learn, work, and play.
This investment will help address gaps in care, including patient-
centered services, care to tribal communities, and direct support to
rural communities to respond to hospital closures and workforce
shortages.
Without the funding requested in the fiscal year 2023 President's
Budget for these new or expanded programs, HRSA will be unable to
adequately support these important efforts. These critical investments
will help transform maternal healthcare to better meet women where they
are with the services they need, especially women of color and those in
underserved and rural communities, and to reduce health disparities and
improve maternal health outcomes.
The fiscal year 2023 budget addresses gaps in care by expanding and
diversifying the perinatal workforce with new investments in the doula
($20 million) and certified nurse midwife ($25 million) workforces,
along with funding to create a research network for minority-serving
institutions to advance maternal health research and practice that
focuses on addressing health disparities and equity ($10 million).
The budget also proposes new investments to address social and
structural determinants of health including:
--A new program, Addressing Emerging Issues and Social Determinants
of Maternal Health ($55 million), that will:
--Support communities in addressing social determinants of maternal
health for pregnant and postpartum individuals to address
racial and ethnic disparities;
--Expand access to behavioral health services;
--Promote equitable access to care through digital tools; and
--Support technology-enabled collaborative learning to build
provider capacity to improve maternal health outcomes.
--Increased funding for Healthy Start ($145 million, $13 million
above fiscal year 2022 enacted) to support new programs in
communities with the highest rates of disparities to address
factors that contribute to disparities in poor outcomes for
mothers and their babies, including mothers of color.
The budget also includes a Pregnancy Medical Home Demonstration
Project ($25 million) to support integrated healthcare services to
pregnant women and new mothers; Implicit Bias Training Grants for
Health Care Providers ($5 million); and a National Academy of Medicine
Study on incorporating bias recognition in clinical skills testing ($1
million).
The budget proposes increases for existing programs that help
expand access and improve quality of maternal health for women of
color. These include the State Maternal Health Innovation Grants ($55
million, $26 million increase from fiscal year 2022 enacted) that
implement state specific innovative action plans to improve access to
maternal care services and address workforce needs and the Alliance for
Innovation on Maternal Health ($15 million, $3 million above fiscal
year 2022 enacted) to expand the implementation of maternal safety
bundles.
To increase access in areas with healthcare shortages, the budget
increases funding for Rural Maternity and Obstetrics Management
Strategies ($10 million, $4 million above fiscal year 2022 enacted) to
expand access to maternal and obstetrics care in rural communities. The
budget also invests in
Maternity Care Target Areas ($5 million, $4 million above fiscal
year 2022 enacted) to help better identify areas in need of provider
capacity.
The budget expands access to behavioral healthcare for pregnant and
postpartum women through increased investments in the Screening and
Treatment for Maternal Depression program ($10 million proposed for
reauthorization, $3.5 million above fiscal year 2022 enacted) and the
Maternal Mental Health Hotline ($7 million, $3 million above fiscal
year 2022 enacted).
Finally, the budget also increases funding for the Maternal,
Infant, and Early Childhood Home Visiting Program (MIECHV) ($467
million, an increase of $67 million from the fiscal year 2022 enacted
level of $400 million) to expand the capacity of MIECHV awardees to
reach more women, families, and communities. Current authorization of
the MIECHV Program is set to expire at the end of fiscal year 2022.
The HHS Office on Women's Health initiated an $8 million nationwide
contract with a healthcare improvement company to improve maternal
health data and recruited 220 nationally representative hospitals to
deploy clinical, evidence-based best practices in maternity care. The
Maternal Morbidity and Mortality Data and Analysis Initiative builds
upon HHS's maternal health work as outlined in the President's fiscal
year 2021 Budget. This vital data will inform policy and validate
evidence-based practice to improve maternal and infant health outcomes.
OWH would have used additional funds to recruit more hospitals that
serve Black women, Tribal women, and women who live in rural areas to
participate in the Maternal Morbidity and Mortality Data and Analysis
Initiative.
Question. How will the $470 million requested in the President's
new budget address the disparities for women of color and women who
live in rural areas?
Answer. The fiscal year 2023 President's Budget invests in several
HRSA programs to address disparities for women of color and women who
live in rural areas, including:
--An increase to the Healthy Start program ($145 million, $13.16
million above fiscal year 2022 enacted) to support new programs
in communities with the highest rates of disparities, focusing
on addressing the unique structural, environmental, and
systemic factors that contribute to disparities in poor
outcomes for mothers and their babies.
--New funding to support an Addressing Emerging Issues and Social
Determinants of Maternal Health program ($55 million) that will
support community-based investments to improve outcomes
particularly in areas with high rates of adverse maternal
health outcomes and/or significant racial and ethnic
disparities in maternal health outcomes. Efforts may focus on
addressing social determinants of maternal health for pregnant
and postpartum individuals; expanding access to behavioral
health services for women; promoting equitable access to care
through digital tools; and supporting technology-enabled
collaborative learning to build provider capacity to improve
maternal health outcomes.
--A proposed $10 million in funding for minority-serving institutions
to support research on health equity and racial disparities in
maternal health. Institutions may use funds to promote
diversity within the workforce and advance research into the
field of maternal minority health to best serve their patient
populations.
--An increase in funding for MIECHV ($467 million, an increase of $67
million from the fiscal year 2022 enacted level of $400
million) would expand the capacity of MIECHV awardees to reach
more women, families and communities. Current authorization of
the MIECHV Program is set to expire at the end of fiscal year
2022.
--The MIECHV Program supports voluntary, evidence-based home
visiting services for pregnant people and parents with
young children up to kindergarten entry living in
communities that face greater risks and barriers to
achieving positive maternal and child health outcomes.
MIECHV-funded programs currently serve 71,000 families,
reaching only approximately 15 percent of the more than
465,000 families who are likely eligible and in need of
MIECHV services. With the proposed five-year funding
increase, HRSA anticipates the MIECHV Program could provide
home visiting services to up to 165,000 additional families
in over 600 additional communities through targeted
evidence-based home visiting over the course of 5 years.
--The MIECHV Program also includes a 3 percent set-aside for grants
to Tribal organizations to implement home visiting programs
in American Indian and Alaska Native communities, which
include geographically rural areas.
--The budget also expands the Screening and Treatment for Maternal
Depression and Related Behavioral Disorders (MDRBD) program
($10 million, $3.5 million above fiscal year 2022 enacted) to
expand healthcare providers' capacity to screen, assess, treat,
and refer pregnant and postpartum individuals for maternal
depression and related behavioral disorders, including in rural
areas and medically underserved areas. Current authorization of
the MDRBD program is set to expire at the end of fiscal year
2022.
The fiscal year 2023 President's Budget includes $164 million, an
increase of $81 million over the fiscal year 2022 enacted level, for
the Safe Motherhood and Infant Health Activities at CDC. This increase
would help optimize critical public health infrastructure, improve
maternal health outcomes, and eliminate persistent racial/ethnic and
geographic disparities in healthcare outcomes. Investments in state,
local, and territorial public health infrastructure would dramatically
improve timely and relevant clinical, non-clinical, and systems level
data to guide implementation and evaluation of maternal and infant
health policies and programs. In addition to expanding the ERASE MM
Program to all 50 states, Washington D.C. and territories, the fiscal
year 2023 President's Budget includes support for key public health
infrastructure, including expanding Maternal Mortality Review
Committees (MMRCs) capacity to acquire detailed and complete data on
maternal mortality and develop recommendations for prevention. CDC is
partnering with HHS' Office of Minority Health and others to build a
health equity framework for maternal mortality review and prevention.
With this proposed increase, CDC would also modernize the Pregnancy
Risk Assessment Monitoring System (PRAMS) to test and implement
strategies for rapid-data collection and dissemination, including
facility-based data collections; establishing individual, facility, and
community level data linkages); improve response rates and
representative samples; and develop a queryable data system. PRAMS
collects jurisdiction-specific, population-based data on maternal
attitudes and experiences before, during, and shortly after pregnancy
and are used to better understand emerging issues in the field of
reproductive health. CDC would also support significant expansion of
the Hear Her Campaign, which is an effort to prevent pregnancy-related
deaths by sharing potentially life-saving messages about urgent warning
signs. Finally, CDC would promote diverse and representative community
engagement in MMRCs and Perinatal Quality Collaboratives (PQCs).
OWH initiatives aim to address disparities and advance health
equity for women across the life course for women of color and women
who live in rural areas. The President's new budget will allow OWH to
continue ongoing initiatives, such as our Breastfeeding Education and
Promotion Campaign for African American Mothers and Families. An
increase in the budget would also allow OWH to increase the funding
amount for the Reducing Maternal Deaths due to Substance Use Disorder
grant opportunity.
Question. The President's budget includes increased funding to end
HIV in the U.S. as well as an increased focus on PrEP for medications
that prevent HIV. These drugs, which can be a daily oral regimen or
now, long acting injectables, are underutilized in the communities that
need them most, such as Black and Latino gay men, and Black women,
particularly in the South. The budget proposes a new $9.8 billion
mandatory spending PrEP delivery program that largely focuses on bulk
purchasing of generic drugs.
Please provide detail to support how HHS calculated the $9.8
billion figure over 10 years.
How will the $9.8 billion be allocated for different services and
distributed to communities throughout the country? Please provide
detail on what is needed to cover the costs of the drug, as well as
community outreach, and provider education and training programs.
Answer. The new mandatory Pre-Exposure Prophylaxis Delivery Program
to End the HIV Epidemic in the United States (``PrEP Delivery
Program'') is designed to expand access to PrEP and essential
wraparound services for uninsured and underinsured individuals at high
risk of HIV infections across the United States.
This national program would create a financing and delivery system
for PrEP. Currently, there is a patchwork of PrEP access programs for
uninsured individuals; this comprehensive new program is a key pillar
of the Administration's efforts to meet the commitments laid out in the
National HIV/AIDS Strategy for the United States 2022-2025 to reduce
HIV infections by 75 percent by 2025.
The PrEP Delivery Program will guarantee access to PrEP at no cost;
eliminate costs for essential associated services; and establish a
network of providers in underserved communities that provide culturally
and linguistically appropriate services. It will create an efficient,
systematic approach to drug acquisition and distribution and also
provide the critical wrap-around services that make it possible for
individuals to successfully participate in the ongoing intervention.
The Department will purchase PrEP medications in bulk directly from
manufacturers, leveraging its large purchasing power to obtain the
lowest possible price, creating a long-term, sustainable model for
purchasing medication. The PrEP Delivery Program will expand PrEP
access at clinical settings through on-site dispensing and lab services
for those without healthcare coverage.
Additionally, the PrEP Delivery Program will establish and support
PrEP programs for state, tribal, and local public health departments,
community-based organizations (CBOs), and healthcare facilities that
serve the highest risk populations, such as the CDC's health department
and CBO grantees, tribal-servicing organizations, STI clinics,
community health centers, Title X clinics, substance use disorder
treatment programs, mobile prevention units, homeless shelters, and
domestic violence shelters. These organizations will administer the
program for clients and work to implement PrEP education campaigns,
medication support services, and provide outreach and education to
increase utilization of PEP and PrEP among individuals at risk of HIV
infection.
Question. Nationwide, we're facing a child care crisis. Parents are
struggling to find or afford child care, and too many can't get the
early education or pre-k that would help their children thrive. At the
same time, early educators are making poverty wages and can't make ends
meet, and are leaving the field to get higher pay elsewhere, which is
creating real problems in Head Start classrooms, where programs cannot
find enough staff to fully operate.
A cost-of-living adjustment is critical in the Head Start Program
to allow programs to keep up with inflation, but may not adequately
address the issues programs are having recruiting and retaining highly-
qualified educators. How does the proposed budget address the child
care and early educator shortages we are seeing nationwide?
Answer. Head Start programs across the nation are facing workforce
challenges and this instability prevents classrooms from being fully
staffed. Low wages have been a key driver for turnover among the early
childhood education workforce. With that in mind, the fiscal year 2023
President's Budget includes a request for funding to provide a cost-of-
living adjustment and allow programs to keep pace with inflation. While
this does not help make wages to be more competitive, it does help
preserve their real value.
______
Questions Submitted by Senator Richard J. Durbin
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 these emotional scars can harm the
developing brain, change the way a child sees the world, and 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 substance use disorder--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. We have
now secured $17 million over the past 3 years for this work. We also
created the Interagency Task Force on Trauma-Informed Care that brings
our Federal agencies around the table to promote trauma ``best
practices'' in every grant program, we were pleased to secure $1
million in fiscal year 2022 for this effort. And in fiscal year 2022,
we provided $7 million for the first time to stand up a trauma and
mental health support program in schools, under Project AWARE (Sec.
7134 of the SUPPORT Act).
Now, the 2023 budget proposes a $250 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 needed to grapple with our gun violence
epidemic--including street outreach efforts, and trauma programming in
schools.
Under a program called the HEAL Initiative that I launched with the
ten largest hospitals serving Chicago, as hospitals stitch up their
physical wounds, they also pair victims of violence with counselors to
address their trauma to prevent retaliations--otherwise nearly half of
those gunshot victims would wind up back in the hospital within 5
years. They are also improving data-sharing across hospitals and
getting into the community to delivery violence prevention and
intervention services.
Secretary Becerra, can you explain how this new community-violence
proposal can support programs like those in Chicago, and how you
envision these various Federal trauma and violence prevention programs
working together?
Answer. SAMHSA leads the Interagency Task Force for Trauma-Informed
Care. The Task Force is comprised of 21 agencies and has been
identifying, evaluating, and making recommendations regarding best
practices for children and families who have experienced trauma or are
at risk of experiencing trauma and ways Federal agencies can better
coordinate responses to families affected by substance use disorders
and trauma. The Task Force developed a National Strategy for Trauma-
informed Care grounded in four pillars: best practices, research, data,
and Federal coordination. The fiscal year (FY) 2023 budget request will
help support SAMHSA in leading the Task Force; collecting data and
identifying and evaluating trauma-informed resources for practice;
making recommendations to the general public and to Federal agencies
through an Internet website; ongoing solicitation of input from
stakeholders to inform the work; and coordinating Federal agencies in
their integration of trauma-informed principles and interventions into
their ongoing work.
The ACEs work is a critical priority at CDC. People who experience
ACEs are more likely to have physical, mental and behavioral health
challenges, including future experiences with violence. We understand
even more now that protective factors, including but not limited to
growing up in communities with access to nurturing and safe childcare
and strong partnerships with businesses, healthcare, government, and
other sectors, help establish safe and stable environments across
generations. Through our program Preventing ACEs: Data to Action (PACE:
D2A), we currently fund six states to build a state-level surveillance
infrastructure that ensures enhances the capacity to collect, analyze,
and use ACEs data to inform ACEs prevention activities and to support
implementation of ACEs primary prevention strategies selected from the
best available evidence.
CDC will continue to work to better understand both protective and
risk factors as well as primary prevention strategies and contribute to
the evidence base for community violence prevention work. In addition,
there is a great need at the state and local level for resources to
support this critical work. The fiscal year 2023 President's Budget
includes a request for an additional $8 million in funding to further
support states in ACEs prevention.
The $250 million investment proposed for community violence
intervention in the fiscal year 2023 President's Budget has been
designed to stem the rise of violence in cities across the country
through prioritizing evidence based-prevention strategies, research,
and data to inform action. With these funds, CDC would support up to 75
cities and communities disproportionately impacted by homicides to
establish a collaborative, community driven approach to reduce
community violence. CDC would also expand our research and evaluation
investments to further build the evidence base for preventing violence
in communities experiencing the greatest burden, and to reduce the
racial, ethnic, and economic inequities that characterize such violence
across our country.
Hospital-community partnerships, such as the Chicago Hospital
Engagement, Action and Leadership (HEAL) Initiative that you mentioned,
represent one type of strategy to prevent and reduce community violence
and could be supported under the proposed community violence
initiative. Rigorous evaluation will be an important component of CDC's
community-violence prevention work to help us identify the most
effective programs for reducing community violence and re-injury.
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 hospital-
community partnerships, can create safer, healthier, and more resilient
communities. For more information about these upstream approaches, we
would recommend CDC's A Comprehensive Technical Package for the
Prevention of Youth Violence and Associated Risk Behaviors.
Question. Too often in our country, new moms and infants--
especially women and babies of color--are dying from preventable health
problems. Nationwide, more than 800 women die every year as a result of
pregnancy--more than 70,000 others have near-fatal complications. And
it's getting worse--we saw a 15 percent increase in maternal deaths in
2020 compared with 2019.
In Illinois, more than 70 women die every year due to pregnancy-
related complications--70 percent of these deaths are preventable.
Not only are we losing new moms, we also are losing their babies.
Annually, more than 23,000 babies die in the U.S., many due to
preventable factors, such as pre-term birth and low birth weight.
I introduced a bill--the MOMMA's Act--to expand Medicaid coverage
to new moms for a year post-partum, versus 60 days. A version of my
bill was included in the American Rescue Plan, and Illinois was the
first state to offer this expanded Medicaid coverage.
How many states have now expanded their Medicaid programs for new
moms, and how do you think this change will improve health outcomes for
new moms and babies?
Answer. CMS has taken a series of actions to further advance the
safety and quality of maternal care. CMS is encouraging hospitals to
implement evidence-based patient safety practices for managing
obstetric emergencies along with interventions to address other key
contributors to maternal health disparities.
CMS encourages states to take advantage of the American Rescue
Plan's option to provide 12 months of postpartum coverage to pregnant
individuals who are enrolled in Medicaid or CHIP beginning April 1,
2022. Even before this option became available, in 2021, CMS approved
section 1115 demonstrations in Georgia, Illinois, New Jersey, and
Virginia to extend Medicaid and CHIP postpartum coverage beyond the
required 60-day postpartum period.
On April 1, 2022, Louisiana became the first state to use the ARP
option to extend Medicaid postpartum coverage to 12 months, covering an
estimated 14,000 pregnant and postpartum individuals. Two weeks later,
Michigan received CMS approval to extend postpartum coverage to 12
months for an estimated 16,000 pregnant and postpartum individuals. CMS
continues working with other state partners to extend coverage for 12
months after pregnancy, which has also been proposed in several other
states, including Indiana, Maine, Minnesota, New Mexico, Pennsylvania,
West Virginia, North Carolina, South Carolina, Tennessee, Washington,
and Connecticut, as well as the District of Columbia. As a result of
these efforts, as many as 720,000 pregnant and postpartum individuals
across the United States, annually, could be guaranteed Medicaid and
CHIP coverage for 12 months after pregnancy.
Question. A large majority of Americans take dietary supplements
daily--from calcium chews, to multi-vitamins, to fish oil. Yet, there
is very little oversight or transparency into these products--we do not
even know how many supplements are on the market today, with guesses
ranging anywhere from 50,000 to 80,000.
We don't know because FDA doesn't currently have the authority to
require dietary supplement companies to register their products, nor
are they required to submit ingredient lists, allergen statements,
health claims, or even the copies of the labels for these products.
Senator Braun and I introduced the bipartisan Dietary Supplement
Listing Act to change all of that. Our bill--which is supported by
dietary supplement companies, as well as consumer and physician
groups--would require companies to provide basic, vital information
about their products.
Mandatory listing of dietary supplements was a new authority that
President Biden--and President Trump--requested in their budgets. Can
you tell the Committee why you think this issue is so important?
Answer. The dietary supplement industry has grown ten times the
size it was when the Dietary Supplement Health and Education Act
(DSHEA) was enacted in 1994. Under DSHEA, FDA does not approve dietary
supplement products, and generally does not review and approve label
claims before dietary supplements are introduced to consumers. As a
result, FDA has no systematic way to know when new dietary supplements
are introduced or what they contain; therefore dangerous and otherwise
unlawful products that contain undeclared or otherwise improper
ingredients continue to be marketed.
The fiscal year 2023 President's Budget includes a legislative
proposal--similar to proposals offered in other recent budgets--for a
mandatory listing requirement for dietary supplements. Under this
proposal, FDA is seeking to modernize DSHEA to strengthen and clarify
FDA's authorities relating to products marketed as ``dietary
supplements.'' These new authorities would allow FDA to know when new
products are introduced and enhance FDA's ability to quickly identify
and act more effectively against dangerous or otherwise illegal
products.
Question. Last year, the President signed into law the Accelerating
Access to Critical Therapies for ALS Act (ACT for ALS)--legislation
spear-headed by Senators Coons and Murkowski. I was pleased to
cosponsor this important legislation, which will fund essential
research into fast-progressing terminal diseases like ALS, and expand
access to promising investigational new therapies.
This issue is personal to me. My friend, and constituent, Brian
Wallach is a 41-year-old man living with ALS. He, and his wife Sandra,
took Brian's terminal diagnosis and turned it into hope-- starting I Am
ALS, an organization that advocates for real, tangible results in the
fight against ALS.
Secretary Becerra, last year, you joined a Zoom with Brian and
Sandra to celebrate ACT for ALS becoming law. Can you talk about the
importance of engagement, input, and collaboration from the ALS patient
leadership community as HHS, NIH, and FDA work to urgently implement
this law?
Answer. The National Institutes of Health (NIH) agrees that
engagement, input, and collaboration with the ALS community will be
crucial for implementing the law. To that end, the U.S. Food and Drug
Administration (FDA) and NIH held a listening session with leaders in
the patient community on March 25 to discuss Access to Critical
Therapies (ACT) for ALS implementation. Additionally, NIH plans to
include people affected by ALS on the review panel for expanded access
grant applications, and the request for applications for this program
strongly encourages applicants to establish relationships with patient
groups and solicit their input on recruitment, the clinical
meaningfulness of the question under study, the relevance of the
proposed clinical outcomes, and approaches to minimizing the burden on
study participants.
Question. Please also clarify what resources you need from Congress
to get this law implemented quickly and efficiently.
Answer. Fiscal Year (FY) 2022 appropriations for NIH included $25
million for ACT for ALS implementation. These funds should be
sufficient for NIH to support the expanded access grant program in
section 2 of ACT for ALS for fiscal year 2022 and to initiate the
Public Private Partnership in section 3 of the statute this fiscal
year.
Question. Secretary Becerra, the budget proposes $848 billion for
Medicare. One of the greatest drivers of outlays by the Medicare
program is the cost of chronic conditions. By some estimates, 10
percent of Medicare spending is attributable to smoking and its health
harms. So it would seem that the Department would want to be doing
everything it can to prevent tobacco use, especially among youth.
While I was pleased to see FDA finally act to ban menthol
cigarettes and all flavors in cigars, I remain concerned that JUUL e-
cigarette products--which fueled the youth vaping epidemic in our
country--remain on the market EIGHT months past a court- ordered
deadline for FDA to act.
For years, FDA refused to act in the face of mounting evidence that
millions of children were becoming addicted to nicotine because of
JUUL--or JUUL knock-off--products. Mango, cool mint, fruit medley--
these were the flavors JUUL used to hook our children. And, today,
despite millions of other products being ordered off the market, JUUL
remains on store shelves--despite not having authorization from FDA.
One could argue that the FDA's actions to regulate virtually every
vaping product except for JUUL is tantamount to clearing the market so
that JUUL can sell its products without competition. In fact, these
products are only on the market today because FDA is exercising
enforcement discretion. They can and should take JUUL off the market
TODAY.
Secretary Becerra, why is the FDA now 8 months past the court
order?
Answer. FDA's review of premarket tobacco product applications
(PMTAs) for electronic nicotine delivery systems (ENDS) continues to be
a high priority for the Department of Health and Human Services and for
FDA, and FDA is committed to completing its review of premarket
applications as soon as possible. FDA has made significant progress on
the entire body of submissions, taking action on 99 percent of the
applications for about 6.7 million products received by the September
9, 2020 deadline. As the Agency has described publicly, FDA has
dedicated resources to the review of applications from companies whose
products account for the largest share of the ENDS market, including
JUUL. These PMTAs tend to be voluminous and complex and have required
additional review time. The Agency has issued decisions for products
from four of the five brands that held more than 95 percent of the ENDS
market in the summer of 2020, when applications were due. But we have
more work to do, including completing review of all of the applications
from the larger market share companies. FDA continues to work
expeditiously on the remaining applications and is issuing decisions on
a rolling basis. The Department and FDA continue to work steadfastly to
transform the ENDS market to one where all products have undergone
thorough scientific review.
Question. Because we are 8 months past the September 9th court-
permitted window, all e-cigarettes that have not been authorized yet
remain on the market currently are only allowed to do so because of
FDA's enforcement discretion. Why not restore the statutory burden of
proof as envisioned in the Tobacco Control Act for manufacturers to
prove to FDA that their products are appropriate for the protection of
public health, by removing all yet-unauthorized products from the
market UNTIL their PMTAs are adjudicated?
Answer. All new tobacco products on the market without the
statutorily required marketing authorization are marketed unlawfully
and are subject to enforcement by FDA. FDA continues to make
enforcement decisions on a case-by-case basis according to its
enforcement priorities and individual circumstances.
FDA is committed to working as quickly as possible to transition
the current marketplace for deemed new tobacco products to one in which
all products available for sale have undergone a careful, science-based
review by FDA and met the statutory standard. It is imperative that we
get it right.
It is also important to note that FDA does not possess independent
litigation authority. FDA works closely with the Department of Justice
(DOJ), without whose support neither injunctive actions nor seizures
can occur. FDA regularly consults DOJ with respect to potential
enforcement actions, including in relation to unauthorized tobacco
products that are the subject of pending applications. Although the
Agency does not discuss the substance of its internal deliberations
with the dedicated attorneys at DOJ, their legal analysis and expert
legal judgment greatly inform FDA's enforcement decisionmaking.
Question. Do you believe that JUUL products--which have been proven
to hook kids on nicotine--benefit the public health?
Answer. At this time, FDA has not authorized any JUUL tobacco
products for marketing.
As you know, premarket tobacco product applications (PMTAs) must
provide scientific data to FDA that demonstrate that permitting the
product to be marketed would be appropriate for the protection of the
public health (APPH). As set forth in Section 910(c)(4) of the Federal
Food, Drug, and Cosmetic Act, the finding as to whether the marketing
of each tobacco product for which an application has been submitted is
APPH shall be determined with respect to the risks and benefits to the
population as a whole, including users and nonusers of the tobacco
product.
FDA continues to work expeditiously on the remaining PMTA
applications and is issuing decisions on a rolling basis. We will keep
your office apprised of any updates and would be happy to offer
briefing or discussion as those decisions are made.
Question. I recently met with the Illinois Health and Hospital
Association, who shared that their top concern is workforce shortages.
But this is not a new problem caused by the pandemic. Even before
COVID, our nation faced a shortfall of 120,000 doctors and a quarter-
million nurses.
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
averaging 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. And less than 10 percent of doctors are Black
or Latino, which can lead 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 Corps.
It will help surge tens of thousands of new clinicians into under-
served areas, and already has built the healthcare pipeline by
quadrupling the number of scholarship recipients.
Secretary Becerra, your budget proposes a significant increase to
the National Health Service Corps. Can you talk about the importance of
this program in addressing our workforce needs, our preparedness, and
health disparities?
Answer. For the past 50 years, the National Health Service Corps
(NHSC) has been a dedicated resource for building healthy communities
by mobilizing a primary care workforce to serve in the nation's high-
need areas. The NHSC does this by providing scholarships and loan
repayment for clinicians who commit to practice in underserved
communities. NHSC-approved sites provide care to individuals regardless
of their ability to pay. Currently, there are approximately 20,000
medical, dental, and behavioral healthcare clinicians, the largest
cohort ever, providing quality care to more than 21 million Americans
in rural, urban, and tribal communities. The increase to the number of
clinicians providing care is the result of the $800 million
appropriated for the NHSC in American Rescue Plan (ARP) Act in fiscal
year 2021, $700 million of which is for the NHSC Scholarship Program
(SP), Loan Repayment Programs (LRPs), and Students to Service (S2S).
These funds enabled the NHSC to award all qualified applicants; the
remainder of these funds will be fully obligated in fiscal year 2022.
In recent years, the NHSC has demonstrated the ability to be agile
and address the emerging heath needs across the U.S. States and
Territories. This includes, but is not limited to, supporting a
workforce dedicated to addressing the Zika epidemic (2016), combatting
the nation's substance use disorder crisis (2018-present), and
expanding access to care during the height of the COVID-19 pandemic
(2021-present). Further, NHSC appropriations have been dedicated to
deliver healthcare services in Indian Health Service facilities,
Tribally-Operated 638 Health Programs, and Urban Indian Health Programs
(ITUs). With this directed funding, the NHSC has awarded all eligible
clinicians serving in ITUs who applied to the NHSC Loan Repayment
Programs (LRPs).
Through the NHSC Substance Use Disorder (SUD) Workforce loan
repayment program and Rural Community loan repayment program, HRSA is
working to support the SUD workforce needs of underserved communities
by helping to recruit and retain health professionals to improve access
to quality opioid and evidence-based SUD treatment in rural and
underserved areas nationwide, and to prevent overdose deaths. As of
September 30, 2021, there are more than 44,000 clinicians in the NHSC
providing substance use disorder treatment.
Additionally, ensuring greater racial and ethnic diversity of the
healthcare workforce is essential for increasing access to culturally
competent care for all patients, improving opportunities and
representation of all groups within the health professions, and meeting
the overall needs of our diverse population, particularly in the most
underserved areas.\2\ Many racial and ethnic minority groups are
underrepresented nationally within the major health professions,\3\ and
the share of racial and ethnic minority NHSC providers exceeded their
share in the national workforce:
---------------------------------------------------------------------------
\2\ Cohen JJ, Gabriel BA, Terrell C. The case for diversity in the
healthcare workforce. Health Aff (Millwood). 2002 Sep-Oct; 21(5): 90-
102 (http://content.healthaffairs.org/content/21/5/90.full).
\3\ U.S. Department of Health and Human Services, Health Resources
and Services Administration, National Center for Health Workforce
Analysis. Sex, Race, and Ethnic Diversity of U.S. Health Occupations
(2010-2012), Rockville, Maryland; 2014 (https://bhw.hrsa.gov/sites/
default/files/bhw/nchwa/diversityushealthoccupations.pdf).
---------------------------------------------------------------------------
Primary Care
--Black or African American physicians represented 14.9 percent of
the NHSC LRP and Scholarship Program (SP) participants,
exceeding their 5.0 percent share in the national physician
workforce.\4\
---------------------------------------------------------------------------
\4\ Association of American Medical Colleges, Diversity in
Medicine: Facts and Figures, 2019. (https://www.aamc.org/data-reports/
workforce/interactive-data/figure-18-percentage-all-active-physicians-
race/ethnicity-2018).
---------------------------------------------------------------------------
--Hispanic or Latino physicians represented 12.9 percent of the NHSC
LRP and SP participants, exceeding their 5.8 percent share in
the national physician workforce.\5\
---------------------------------------------------------------------------
\5\ Ibid.
---------------------------------------------------------------------------
--American Indian and Alaska Native physicians represented 1.6
percent of the NHSC LRP and SP participants, exceeding their
0.3 percent share in the national physician workforce.\6\
---------------------------------------------------------------------------
\6\ Ibid.
---------------------------------------------------------------------------
--Black or African American nurse practitioners represented 15.7
percent of the NHSC LRP and SP participants, exceeding their
9.1 percent share in the national healthcare workforce averages
of nurse practitioners.\7\
---------------------------------------------------------------------------
\7\ U.S. Department of Labor, Bureau of Labor Statistics Labor
Force Characteristics by Race and Ethnicity, 2020, November 2021,
Report 1095.
---------------------------------------------------------------------------
--Hispanic or Latino nurse practitioners represented 9.1 percent of
the NHSC LRP and SP participants, exceeding their 6.3 percent
share in national healthcare workforce averages of nurse
practitioners.\8\
---------------------------------------------------------------------------
\8\ Ibid.
---------------------------------------------------------------------------
Mental and Behavioral Health
--Asian health services psychologists represented 5.8 percent of the
NHSC LRP participants, exceeding their 4.1 percent share in the
national healthcare workforce averages of health services
psychologists.\9\
---------------------------------------------------------------------------
\9\ Ibid.
---------------------------------------------------------------------------
--Hispanic or Latino health services psychologists represented 20
percent of the NHSC LRP participants, exceeding their 3.5
percent share in the national healthcare workforce averages of
health services psychologists.\10\
---------------------------------------------------------------------------
\10\ Ibid.
---------------------------------------------------------------------------
Oral Health
--Black or African American dentists represented 13 percent of the
NHSC LRP and SP participants, exceeding their 1.4 percent share
in the national healthcare workforce averages of dentists.\11\
---------------------------------------------------------------------------
\11\ Ibid.
---------------------------------------------------------------------------
--Hispanic or Latino dental hygienists represented 20 percent of the
NHSC LRP participants, exceeding their 10.5 percent share in
the national healthcare workforce averages of dental
hygienists.\12\
---------------------------------------------------------------------------
\12\ Ibid.
---------------------------------------------------------------------------
Based on self-reports of the 2,523 NHSC scholars (i.e., those in
school, pursuing post-graduate training, or awaiting placement in an
NHSC-approved service site), 22 percent are Black or African American,
16.8 percent are Asian or Pacific Islander, 2.3 percent are American
Indian or Alaska Native, and 14.1 percent of NHSC scholars self-
reported as Hispanic or Latino. Black or African American NHSC scholars
exceeded national student enrollment averages in dentistry, medicine,
physician assistant, and nursing disciplines.\13\ Hispanic or Latino
NHSC scholars exceeded student enrollment averages in dentistry,
representing 15.7 percent of the Corps' dental participants, compared
to their 9.0 percent share of the national student enrollment.\14\
American Indian and Alaska Native NHSC scholars exceed national student
enrollment averages in dentistry, medicine, physician assistant, and
nursing disciplines.\15\
---------------------------------------------------------------------------
\13\ American Dental Association, 2018-2019 Survey on Dental
Education: Academic Programs, Enrollments, and Graduates. Association
of American Medical Colleges Total U.S. Medical School Enrollment,
2020-2021. American Association of Colleges of Nursing, 2021. 35th
Physician Assistant Education Association Annual Report, 2019.
\14\ Ibid.
\15\ Ibid.
---------------------------------------------------------------------------
______
Questions Submitted by Senator Brian Schatz
Question. I am concerned we are facing a cliff for digital health
when the public health emergency ends. Last month you said that when it
comes to telehealth we cannot let the ``old way of business get in the
way''. I agree, and so do 61 of my colleagues who have cosponsored my
CONNECT for Health Act. HHS's current authority to expand Medicare's
coverage of telehealth expires 151 days after the public health
emergency ends. Unless Congress acts to ensure permanent expansion of
Medicare coverage authorities, we will go back to the dark ages with
very limited access to telehealth. During the pandemic, you also waived
requirements for other communication technology-based services that CMS
could amend without additional authorities needed from Congress.
Finally, CMS provided robust guidance to states to increase access to
telehealth for individuals in Medicaid and CHIP during the pandemic.
What are the factors you are considering for when this public
health emergency could be declared over?
What is CMS's plan regarding the pandemic flexibilities granted for
communication technology-based services, such as remote physiologic
monitoring, remote therapeutic monitoring, and virtual check-ins?
How is HHS continuing your work with states beyond the public
health emergency to ensure that individuals enrolled in Medicaid and
CHIP have the same access to telehealth services as those with
commercial insurance?
Answer. During the COVID-19 public health emergency, telehealth has
been a reliable resource, allowing healthcare providers to reach
patients directly in their homes to ensure access to care and
continuity of services. The Biden-Harris Administration is committed to
supporting a temporary extension of broader telehealth access under
Medicare beyond the declared COVID-19 Public Health Emergency (PHE) in
order to study its impact on utilization of services and access to
care. Telehealth, including audio-only telehealth, can greatly expand
access to services for individuals who may not have access to broadband
or technology to support 2-way audio-video. This is particularly true
in rural and underserved areas, and among older populations.
The Administration is also expanding access to mental health and
beneficiary-centered care under Medicare through greater use of
telehealth and other telecommunications technologies to provide
behavioral healthcare, among other services. Medicare beneficiaries can
access care directly in their homes thanks to recent statutory
amendments (CAA, 2021), and using audio-only technology where
appropriate based on the patient's needs thanks to changes in
regulations, including in CMS's CY 2022 Physician Fee Schedule (PFS)
final rule, that allow payment for certain behavioral health services
via audio-only telephone calls.
In addition, the President's fiscal year 2023 Budget includes a
proposal to remove statutory limits on the list of practitioners that
are authorized to receive direct Medicare payment for their mental
health services, which would expand access to mental health services in
Medicare, especially in rural and underserved areas with fewer mental
health professionals or in communities more likely to receive care from
the referenced practitioners.
CMS has released numerous resources to help states identify
opportunities for increasing the use of telehealth services within
Medicaid and CHIP. For example, CMS developed Medicaid & CHIP
Telehealth toolkit to help states accelerate adoption of broader
telehealth coverage policies in Medicaid and CHIP during the COVID-19
PHE. This toolkit provides states with statutory and regulatory
infrastructure issues to consider as they evaluate the need to expand
their telehealth capabilities and coverage policies. The toolkit also
includes a compilation of frequently asked questions and other
resources available to states. CMS also released a supplement to the
toolkit to provide additional support to state Medicaid and CHIP
agencies in their adoption and implementation of telehealth as they
begin to plan beyond PHE flexibilities. States may use this
supplemental toolkit to help think through how they will explain and
clarify which policies are temporary or permanent, when flexibilities
will expire, which services can be accessed through telehealth, which
providers may deliver those services, the modality they may use to
deliver telehealth services, and the circumstances under which
telehealth can be reimbursed. Several state profiles are included in
this toolkit.
Question. Healthcare workforce shortages are at critical levels in
many parts of the country. In addition to workforce training and
retention programs, state licensure portability can be an important
strategy to increase access to care. As states have begun rescinding
licensure waivers, providers are confronting a state patchwork that
impacts some from effectively practicing across state lines.
Keeping patient safety in mind, what authority do you need to
enhance licensure portability and reciprocity and address regulatory
restrictions for providers?
Answer. HRSA's Office for the Advancement of Telehealth supports
the Licensure Portability Grant Program under the authority of Section
330L of the Public Health Service Act. States establish their licensure
requirements for healthcare providers. However, the Licensure
Portability Grant Program assists providers with cross-state licensure
by providing funding to work with state licensure boards to create
multi-state licensure compacts. Through this program, HRSA provides
support to the Federation of State Medical Boards (FSMB) and the
Association of State and Provincial Psychology Boards (ASPPB). The FSMB
created the Interstate Medical Licensure Compact (IMLC), which offers a
voluntary, expedited pathway to licensure for qualified physicians to
practice in multiple states, including physicians participating in
Medicare and Medicaid. The ASPPB created the Psychology
Interjurisdictional Compact (PSYPACT) to facilitate telehealth and
temporary in-person, face-to-face practice of psychology across
jurisdictional boundaries.
Question. Please list and describe the state policies that HHS
helped to enact and/or implement through its Licensure Portability
Program.
Answer. The purpose of the Licensure Portability Grant Program is
to provide support for state professional licensing boards to carry out
programs under which licensing boards of various states cooperate to
develop and implement state laws and related policies that will reduce
statutory and regulatory barriers to telemedicine, such as creating
multi-state licensure compacts. Since states establish their licensure
requirements, HHS does not have the authority to change state policies.
Question. What resources would be needed to ramp up HHS's efforts
to support state licensure portability?
Answer. The two grantees supported through the Licensure
Portability Program, the FSMB and ASPPB, have developed several tools
to facilitate access to inter-state telehealth services. These include
the Interstate Medical Licensure Compact (36 states, Guam, and the
District of Columbia), the Provider Bridge (www.ProviderBridge.org),
the Psychology Inter- jurisdictional Compact, also known as PSYPACT (33
states), and the Licensure Project (www.LicensureProject.org).
Together, these tools support a range of clinicians, including
physicians, physician assistants, nurses, occupational therapists,
physical therapists, psychologists, and social workers. Resources could
be used to continue the use of tools such as www.ProviderBridge.org and
www.LicensureProject.org, expand on efforts to get more states to join
the compacts, and support new grantees through the Licensure
Portability Program, which would expand the types of healthcare
disciplines that are included in the Licensure Portability Program.
HHS is committed to continuing to work within the confines of the
law to strengthen the healthcare workforce and connect skilled
providers with communities in need including through the use of
telehealth. Medicare defers to state law with regard to licensure
issues.
Question. Remote patient monitoring (RPM) allows providers to track
patients' health metrics and empowers individuals to effectively manage
their conditions at home. These tools can improve access to care and
health outcomes. Through its Physician Fee Schedule rulemaking, CMS has
eliminated some barriers to coverage and payment for RPM services.
However, some policies may not adequately address the 77 percent of
older adults with at least two chronic conditions who are
disproportionately low-income and from minority communities, and could
benefit from multiple technologies.
How is HHS enabling the use of technology, such as remote
physiologic monitoring and remote therapeutic monitoring, for Medicare
beneficiaries who have comorbid chronic health conditions, e.g.,
diabetes, hypertension, obesity, depression?
Answer. CMS is committed to ensuring our beneficiaries receive
high-quality, coordinated care that helps them manage their health.
Care coordination and tools such as telehealth and other virtual
services can be particularly beneficial for those with one or more
chronic health conditions. The COVID-19 public health emergency (PHE)
has highlighted that telehealth and other communications technologies
can be a reliable resource that allows healthcare providers to reach
patients directly in their homes in order to ensure access to care and
continuity of services.
In recent years, we have engaged in efforts to update and improve
care management and coordination services within the physician fee
schedule including chronic care management services, which involve
patients with at least two chronic conditions. We also established
payment for remote therapeutic monitoring services which can be used to
monitor a variety of chronic and acute health conditions.
The Biden-Harris Administration is also committed to supporting a
temporary extension of broader telehealth access under Medicare beyond
the COVID-19 Public Health Emergency declaration in order to study its
impact on utilization of services and access to care. Telehealth,
including audio-only telehealth, can greatly increase access to
services for individuals who may not have sufficient bandwidth or
technology to support 2-way audio-video, particularly in underserved
areas and among older populations.
Question. The Native Hawaiian Health Care Improvement Act (NHHCIA)
was enacted in furtherance of the Federal trust responsibility of the
U.S. government to provide resources to raise the health status of
Native Hawaiians. By statute, Papa Ola Lokahi is identified as the
single administrative entity responsible for carrying out specific
functions. In this capacity, Papa Ola Lokahi must utilize its community
expertise to administer the program and work with the five mandated
Native Hawaiian healthcare systems to ensure delivery of culturally
appropriate care that improves the health status of Native Hawaiians.
The NHHCIA does not list among the Secretary's responsibilities the
role of identifying a grantee through a competitive application or
evaluation process. Instead, the Secretary is obligated to execute a
grant or contract with Papa Ola Lokahi and to evaluate its performance.
How is HHS applying its special obligations under Federal trust
responsibility to administer the NHHCIA grants?
Answer. In fiscal year 2021, HRSA released a Notice of Funding
Opportunity to make available appropriated funding authorized by the
Native Hawaiian Health Care Improvement Act for a service grant to Papa
Ola Lokahi for activities described in the NHHCIA, including
coordination of healthcare programs and services provided to Native
Hawaiians, and service grants to 5 certified community-based Native
Hawaiian Health Care Systems (NHHCS) to provide a full range of
services identified by the legislation and tailored to fit the needs of
their respective island communities.
Question. How is HHS applying culturally appropriate standards
aligned with the specific goals of the NHHCIA to hold Papa Ola Lokahi
and the Native Hawaiian healthcare systems accountable for raising the
health status of Native Hawaiians?
Answer. The most recent Notice of Funding Opportunity (NOFO)
identifies that funding is intended to improve the provision of
comprehensive disease prevention, health promotion, and primary
healthcare services for Native Hawaiians. The requirements outlined in
the NOFO hold Papa Ola Lokahi and the Native Hawaiian healthcare
systems accountable for reporting the following: progress towards goals
that align with the NHHCIA, strategies used to overcome challenges
encountered in meeting those goals, and changes in the needs of the
target population and service area. Clinical quality measures focus on
progress made by NHHCS towards health needs pertinent to the target
population and are aligned with standardized measures in HRSA's Uniform
Data System for the Health Center Program. HRSA monitors POL and the
five NHHCS through annual progress reports, regular monitoring calls,
the annual submission of performance data, as well as operational site
visits. HRSA continues to ensure that this oversight is culturally
appropriate.
Question. How is HRSA collaborating with and leveraging the Indian
Health Service's expertise in the Federal trust relationship to
administer the NHHCIA and evaluate grant performance?
Answer. HRSA collaborates with IHS on reporting data methods and
effective community engagement. HRSA also continues to explore new ways
to improve the administration and evaluation of this grant funding.
Question. If the final Supreme Court decision for Dobbs v. Jackson
Women's Health Organization results in the same legal decision as the
leaked draft opinion, Americans will lose their constitutional abortion
rights protections. After Texas passed its six-week abortion ban,
President Biden stated his administration would take a ``whole-of-
government approach'' to abortion rights. During your opening testimony
you noted HHS would ``double down on our authorities''. I appreciate
this commitment, and greater action is needed by HHS to meet this
moment. In a major step last December, the FDA revised its Risk and
Evaluation Mitigation Strategy (REMS) for mifepristone, removing the
in-person dispensing requirement. This decision was consistent with the
legal action Dr. Graham Chelius of Kauai took against HHS when he
recognized that his patients had to fly to Oahu to obtain a drug safer
than Tylenol or Viagra. While I applaud FDA for its revised REMS, I am
concerned that it retained unnecessary requirements.
What is FDA's rationale for maintaining its Patient Agreement Form
requirement when in 2016, FDA staff recommended removal of this
requirement stating it is duplicative of information and counseling
provided to patients under standard informed consent practices and
professional guidelines?
Answer. As part of FDA's 2021 review of the Mifepristone REMS
Program, which involved a detailed analysis of a significant amount of
data, FDA concluded that the Patient Agreement Form remains necessary
to assure the safe use of mifepristone for medical termination of early
pregnancy. This form documents that the prescriber has counseled the
patient on the use of mifepristone, what the serious risks are, and
what to do if the patient experiences an adverse event. FDA's review of
the published literature suggests that the removal of the in-person
dispensing requirement may result in an increase in the number of
providers becoming certified prescribers. The Patient Agreement Form is
an important part of standardizing the medication information on the
use of mifepristone that prescribers communicate to their patients, and
provides the information in a brief and highly understandable format.
Question. FDA justifies mifepristone's provider certification
requirement by noting medical professionals' lack of familiarity and
experience with medication abortion. Simultaneously, it is within your
authority to strengthen the workforce and increase training for
providers. What is HHS's plan to increase the number of providers with
the necessary skills to deliver appropriate care?
Answer. Last January, the Secretary launched an HHS-wide Task Force
on Reproductive Healthcare Access to protect and bolster access to
sexual and reproductive healthcare. This includes looking to ways to
expand access to safe and legal abortion care, permissible under the
law, and includes working to increase information and engagement with
patients and providers to help ensure care. We are continuing to
evaluate and look at our authorities and programs and services and will
continue to keep you apprised of our thinking on this critical issue.
Question. Is FDA considering modifying its REMS for mifepristone,
including its requirement that drug manufacturers must certify
prescribing clinicians and pharmacists, and the rule that patients must
sign an agreement that they understand drug risks?
Answer. To determine whether a modification to the Mifepristone
REMS Program is warranted, in 2021 FDA conducted a comprehensive review
of the published literature, other relevant safety data (including
adverse event data), and information provided by advocacy groups,
individuals, and the applicants. Based on this review, FDA concluded
that mifepristone will remain safe and effective for medical
termination of early pregnancy if the in-person dispensing requirement
is removed, provided all the other requirements of the REMS are met,
and pharmacy certification is added.
Accordingly, on December 16, 2021, FDA sent REMS Modification
Notification letters to the applicants, notifying them that a
modification is necessary and must include removal of the in- person
dispensing requirement and the addition of pharmacy certification.
Following receipt of these letters, the applicants prepare proposed
REMS modifications and submit them to FDA. Once those submissions are
approved, the REMS modifications will be effective.
Question. Is the administration considering challenging state laws
that contradict the mifepristone REMS?
Answer. Last January, the Secretary launched an HHS-wide Task Force
on Reproductive Healthcare Access to protect and bolster access to
sexual and reproductive healthcare. This includes looking to ways to
expand access to safe and legal abortion care, permissible under the
law, and includes working to increase information and engagement with
patients and providers to help ensure care. We are continuing to
evaluate and look at our authorities and programs and services and will
continue to keep you apprised of our thinking on this critical issue.
Question. Does HHS have a plan to increase awareness of medication
abortion--including its safety and efficacy--particularly among
communities whose access to care is limited? Can you please describe
this plan? What resources are needed to execute?
Answer. Last January, the Secretary launched an HHS-wide Task Force
on Reproductive Healthcare Access to protect and bolster access to
sexual and reproductive healthcare. This includes looking to ways to
expand access to safe and legal abortion care, permissible under the
law, and includes working to increase information and engagement with
patients and providers to help ensure care. We are continuing to
evaluate and look at our authorities and programs and services and will
continue to keep you apprised of our thinking on this critical issue
______
Questions Submitted by Senator Joe Manchin, III
Question. One of the most pressing issues West Virginia faces is
shortages across the healthcare sector. Nurses, specialists, you name
it, we likely don't have enough of them. As we continue to address the
COVID-19 pandemic, hospital capacity remains a big issue, especially in
rural areas of the state that already faced significant access to care
issues. In West Virginia, there are about 7,000 licensed hospital beds,
but only enough staff to operate 5,000 of them. That is why Senator
Manchin pushed to include $8.5 billion in the American Rescue Plan
specifically to assist rural healthcare providers, including with
staffing expenses.
What can the Department do to help ensure places like West Virginia
can offer healthcare professionals the resources and tools they need to
continue providing care?
Answer. HRSA is focused on workforce needs in rural areas generally
and hospital capacity in rural areas specifically. In fiscal year 2022,
HRSA will be awarding new programs under the Public Health Workforce
Training Network Program to expand the public health capacity by
supporting healthcare job development to help to address workforce
shortages in rural areas. Additionally, several of HRSA's rural
community-based programs offer non-categorical funding that allows
applicants to propose and build a program in response to an area of
need. HRSA has funded many programs that focus on workforce development
through the Rural Health Network Development, Rural Health Care
Coordination, Rural Health Care Services Outreach, and Delta States
Rural Development Network grant programs. The fiscal year 2023
President's Budget also supports a new pilot program to enable Rural
Health Clinics (RHCs) to strengthen their workforce and bring critical
services to rural communities. The request will fund approximately 18
Rural Health Clinics.
HRSA supports education and training to West Virginians through
grant programs focusing on training primary care providers, nurses,
preventive medicine and addiction specialist physicians, and physician
assistants. These healthcare providers are training in hospitals and
community-based organizations to provide care to rural and medically
underserved communities. In addition, trainings support community-based
collaboration, technology, medically underserved communities, oral
health, minority health, geriatric health, behavioral health focused on
substance use disorder and primary care integration. Course delivery
modes include: classroom-based, self-paced distance learning, real-
time/live distance learning, online webinars, and hybrid trainings with
workshops and clinical rotations.
HRSA will continue to provide resources and tools to assist the
heath care workforce provide quality care. Demonstrated efforts are
shown through the following grant programs:
--The National Health Service Corps (NHSC) increases access to care
in underserved areas by supporting qualified healthcare
providers dedicated to working in underserved communities. The
NHSC received supplemental funds through the American Rescue
Plan Act to support the nation's COVID-19 response and to help
address primary care provider need. In fiscal year 2021, there
were 242 NHSC clinicians serving in West Virginia.\16,17\
---------------------------------------------------------------------------
\16\ Bureau of Health Workforce Clinician dashboards. (n.d.).
Retrieved June 9, 2022, from https://data.hrsa.gov/topics/health-
workforce/clinician-dashboards.
\17\ Bureau of Health Workforce Clinician dashboards. (n.d.).
Retrieved June 9, 2022, from https://data.hrsa.gov/topics/health-
workforce/clinician-dashboards.
---------------------------------------------------------------------------
--The Primary Care Training and Enhancement--Physician Assistant
Rural Training (PCTE-PAR) Program develops and implements
longitudinal clinical rotations in primary care in rural areas.
The program also supports the training and development of
preceptors in rural areas. In fiscal year (FY) 2022, West
Virginia University and Marshall University were awarded PCTE-
PAR Program grants.
--The Nurse Corps Program received supplemental funds through the
American Rescue Plan Act to support our Nation's COVID-19
response and to help address nursing staffing. In fiscal year
2021, Nurse Corps awarded three nursing scholarships in West
Virginia and 14 Nurse Corps loan repayment awards.
--The Behavioral Health Workforce Education and Training (BHWET)
Program aims to increase the supply of behavioral health
professionals while also improving distribution of a quality
behavioral health workforce.
In fiscal year 2021, West Virginia University was awarded a BHWET
Program for Professionals grant. The purpose of their proposed Rural
Integrated Behavioral Health Training (RIBHT) program is to prepare
Master of Social Work students for behavioral health practice, with a
focus on integrated and rural service delivery.
Marshall University was also awarded a BHWET Program for
Professionals grant between AY 2017-2021. The primary focus of the
project is to increase the number of training slots that provide
experience in integrated behavioral health within the primary care
setting for trainees from programs that have previously not offered
such training opportunities. These programs include the Master's
program in Psychology with Clinical and School emphasis, the Masters in
Counseling, and the Psychiatry residency program. Specific attention is
given to understanding the unique needs of rural and underserved
populations in West Virginia and Appalachia in general and how those
needs may impact both behavioral and physical health.
Question. Last month, the Administration released its National Drug
Control Strategy. This strategy lays out the steps the Administration,
in coordination with Federal agency staff across the government, will
take to address the drug epidemic, which Senator Manchin has said time
and time again continues to grow in West Virginia and across the
nation. Prevention and early intervention are listed in the National
Drug Control Strategy as a priority, as they should be. In 2020, the
Substance Abuse and Mental Health Services Administration issued its
annual report on substance use. The report found that 158,000 people
ages 12 to 17 started using prescription pain relievers for the first
time in 2020. While this a decline from previous years, youth substance
use needs our full attention before we lose the next generation of
leaders to the drug epidemic.
What efforts are underway at HHS to address substance use by our
youngest and most vulnerable populations?
Answer. SAMHSA oversees grant programs that utilize evidence-based
programs and promising practices to address substance use by youth ages
12 to 17, among other efforts.
For instance, SAMHSA's Enhancement and Expansion of Treatment and
Recovery for Adolescents, Transitional Aged Youth, and their Families
(Youth and Family TREE) grant program supports substance use disorder
(SUD) treatment specifically for youth, young adults, and their
families with these conditions. Many of SAMHSA's programs include
elements that address youth and young adult SUD issues.
The Screening, Brief Intervention, and Referral to Treatment
(SBIRT) program aims to implement screening, brief intervention, and
referral to treatment services for individuals of varying age groups
and across different settings. The program includes a focus on
screening for underage drinking, opioid use, and other substance use
among youth and young adults in primary care and other health settings
that serve this population (e.g., pediatric healthcare providers,
Children's Hospitals, federally Qualified Health Centers (FQHCs).
Grants to Expand Substance Misuse Treatment Capacity in Family,
Juvenile, and Adult Treatment Drug Court programs support courts that
employ the treatment drug court model to provide SUD treatment
(including recovery support services, screening, assessment, case
management, and program coordination) to youth and young adults
involved in the court system or their parents who are at risk of having
dependency petitions filed against them.
The Sober Truth on Preventing Underage Drinking Act (STOP Act)
program works to prevent and reduce alcohol use among youth and young
adults ages 12-20 in communities throughout the United States. STOP Act
grant recipients serve as a catalyst for increased citizen
participation and greater collaboration among all sectors and
organizations of a community to foster a long-term commitment to
reducing alcohol use among youth. Grant recipients disseminate timely
information to communities regarding state-of-art practices and
initiative that have proven to be effective in prevention and reducing
alcohol use among youth. By being deeply rooted in the community, grant
recipients utilize town halls to gain feedback from communities and
utilize that feedback to implement change and enhance local community
initiatives and strategies.
The Strategic Prevention Framework--Partnership for Success (SPF-
PFS) program works to prevent the onset and reduce the progression of
substance use and its related problems while strengthening prevention
capacity and infrastructure at the community and state level. Utilizing
a data-driven approach, grant recipients identify communities of high
need and at-risk populations of focus, including youths. Grant
recipients utilize community coalition building strategies to advance
substance use prevention efforts across the community and develop
prevention messaging and other prevention strategies to ensure the
dissemination of these messages and strategies.
Additionally, SAMHSA has state level programs that also include
services for youth. SAMHSA's State Opioid Response (SOR) program
provides resources to states and territories, to continue and enhance
the development of comprehensive strategies focused upon preventing,
intervening in, and promoting recovery from issues related to opioid
use, and increasingly stimulant use. The Tribal Opioid Response (TOR)
program provides dedicated resources to perform these activities in
Tribal communities. Both programs aim to address the overdose crisis by
increasing access to the three FDA-approved medications for the
treatment of OUD, reducing unmet treatment need, and reducing opioid-
related overdose deaths through the provision of prevention, harm
reduction, treatment, and recovery support for OUD (including
prescription opioids, heroin and illicit fentanyl and fentanyl analogs)
and stimulant use disorder as so elected by states.
A key component of SOR/TOR grantees' substance use prevention
strategy is the implementation of Evidence Based Practices (EBPs). For
prevention, EBPs are approaches and strategies shown to be effective in
reducing the impact of social and population-based substance use
concerns.
Examples of EBPs that SOR grantees are implementing include Botvin
Life Skills Training; Strengthening Families Program for Parents and
Youth ages 10-14; Project Success; and Sources of Strength, Positive
Action. All of these strategies focus on preventing the initiation of
substance use for at-risk youth. SOR grantees also use funds to support
interventions through Teen Courts, Recovery High Schools, Peer Mentor
Programs, and Clubhouses. Between fiscal year 20 and fiscal year 2021,
approximately 7 percent of individuals receiving treatment and recovery
support services with SOR funds were under the age of 24 at the time-
of-service delivery.
The Substance Abuse Prevention and Treatment Block Grant (SABG)
Program provides funds to all 50 states, the District of Columbia,
Puerto Rico, the U.S. Virgin Islands, 6 Pacific jurisdictions, and 1
tribal entity to prevent SUD, provide treatment and promote recovery
for those with SUD. Under the SABG program, grantees have the
discretion to identify adolescents with SUDs and/or mental health
disorders and children/youth at risk for behavioral health disorders as
priority populations. Between fiscal year 2018-fiscal year 2021, the
SABG program served 330,192 clients ages 17 and under and 729,024
clients ages 18-24.
In addition to directly supporting services for youth and young
adults across the SUD intervention, treatment, and recovery support
continuum, SAMHSA believes that education of the workforce and young
people themselves is needed to have an impact in this area. SAMHSA has
taken concrete steps to educate providers and those who use substances
on the harms of opioid use (prescription and synthetic). SAMHSA
supports a broad range of training and technical assistance resources
that reach the specialty behavioral health treatment community, general
healthcare professionals including students, and the general public.
Providing education on the impact of using opioids empowers these
audiences to educate individuals (youth and adults) on the risks and
harms of using opioids. In addition, reaching youth and young adults
with evidence-based information on avoiding exposure to harmful
substances puts knowledge directly into the hands of those who may be
at highest risk and their peers. This work is augmented through cross-
agency collaboration. SAMHSA representatives regularly meet with other
agencies to foster synergy in the expansion or improvement of SUD
treatment, and how public education might be augmented.
The National Institute on Drug Abuse (NIDA), part of the NIH,
supports research to understand and address substance use and its
consequences across the lifespan, including among vulnerable children
and adolescents. Research findings indicate that substance use and
other drug-related harms are more likely to occur in the presence of
specific risk factors, such as adverse social determinants of health,
and less likely to occur among certain protective factors, like healthy
family and peer relationships and financial stability. Prospective,
longitudinal studies like the HEALthy Brain and Child Development
(HBCD) \18\ and the Adolescent Brain Cognitive Development (ABCD) \19\
studies will help us better understand the specific brain, cognitive,
social, and emotional factors that underlie healthy and unhealthy
development from the prenatal period through young adulthood. These
studies will contribute immeasurably to future substance use prevention
strategies.
---------------------------------------------------------------------------
\18\ https://heal.nih.gov/research/infants-and-children/healthy-
brain.
\19\ https://heal.nih.gov/research/infants-and-children/healthy-
brain.
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Because most opioid and other substance misuse begins during
adolescence and young adulthood, this is a critical period for
prevention. Older adolescents and young adults are at the highest risk
for initiation of opioid use, opioid misuse, opioid use disorder (OUD),
and death from overdose, and there is a need for evidence-based
interventions to prevent OUD. With funding from the Helping to End
Addiction Long-term Initiative (NIH HEAL Initiative), NIDA leads
studies on effective strategies to identify and reach at-risk
individuals in various settings, such as schools, healthcare, justice,
and child welfare systems. For example, one study is testing a video
game opioid use prevention intervention for older teens in school-based
health centers (UH3DA050251-03).\20\ Another study utilizes a
convenient smartphone application to engage high-risk youth in a
mindfulness-based intervention to help them reduce or quit their
substance use (UH3DA050189-03).\21\ Other NIDA-supported studies are
aimed at improving the uptake and reach of existing evidence-based
prevention interventions across settings, developing tailored
approaches for diverse populations, and improving our understanding of
the mechanisms of action for effective prevention approaches. NIDA also
supports research to expand effective screening approaches for pregnant
and postpartum women and school-age children in healthcare settings
(NOT-OD-22-106 \22\ and NOT-OD-22-107) \23\ and, through its NIDAMED
initiative, translates research findings into evidence-based resources
and tools for clinicians to screen for problematic substance use
(Screening for Substance Use in the Pediatric/Adolescent Medicine
Setting).\24\
---------------------------------------------------------------------------
\20\ https://reporter.nih.gov/search/q7GOLosA3kSsoyk3nLnCtQ/
project-details/10408897.
\21\ https://reporter.nih.gov/search/q16mokkSqkSYJFFKEUseMA/
project-details/10441666.
\22\ https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-
106.html.
\23\ https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-
107.html.
\24\ https://nida.nih.gov/nidamed-medical-health-professionals/
science-to-medicine/screening-substance-use/in-pediatric-adolescent-
medicine-setting.
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Finally, monitoring real-world substance exposure among youth is
also critical for informing prevention efforts. NIDA's Monitoring the
Future study, an annual survey of substance-related behaviors,
attitudes, and values of Americans from adolescence through adulthood,
and the Population Assessment of Tobacco Health (PATH) Study, a
national longitudinal study of tobacco and health, are helping us to
better understand the landscape of adolescent substance use to better
target interventions to prevent and reduce youth substance use.
Question. The 340B Drug Pricing Program is essential for providing
access to safe and affordable medications for West Virginians. Senator
Manchin has consistently advocated for the Department of Health and
Human Services to safeguard this essential program and ensure that
pharmaceutical companies cannot blatantly disregard the statutes they
agreed to. We are hearing about practices that undercut this program by
pharmacy benefit managers, or PBMs, known as white bagging or brown
bagging, which puts patients' safety at risk and can dramatically raise
the out-of-pocket costs for patients. This can also force patients to
forgo treatment all together, all so PBMs can receive rebates from the
manufacturers.
What is the Department doing to clamp down on these practices?
Are you monitoring this issue?
How can we as legislators help our constituents who are falling
victim to these bad practices?
Answer. We are aware of the practices of pharmacy benefit managers
under the 340B Drug Pricing Program (340B Program) that you reference.
While there is no statutory provision in the 340B statute prohibiting
the pharmacy benefit management programs from utilizing this approach,
these practices are counter to the intent of the Program, which allows
safety net providers to stretch scarce Federal resources and ensure
that the safety net has access to discounted drugs for its patients. By
pursuing this policy, pharmacy benefit management programs may make it
cost prohibitive for certain covered entities to participate in the
340B Program and reduce services to their patients. We look forward to
working with you on this issue and to continue to support the important
work of the 340B program.
Question. Each year, the Secretary of Labor is required to submit a
report regarding compliance with mental health parity laws. Mental
health parity laws generally prohibit restrictions on mental health
services that are more restrictive than those for all medical and
surgical benefits. Secretary Becerra, in January, your Department,
along with the Department of Labor and the Department of Treasury,
released a report showing that health insurers for the most part are
failing to deliver parity for mental health and substance use disorder
benefits to beneficiaries. Senator Manchin's office has heard from
several constituents who work in the mental health and substance use
disorder workforce that mental health parity laws are simply not being
followed. What's worse, mental health parity laws are not really being
enforced. The bad actors aren't seeing any consequences for their
actions, which are limiting patient access to mental health and
substance use disorder services.
What is the Department doing to ensure mental health parity laws
are being enforced?
Answer. Although SAMHSA has no direct enforcement role in the
implementation of Mental Health Parity and Addiction Equity Act
(MHPAEA), it has been a valued collaborator, partner, and leader on
parity. SAMHSA has actively supported MHPAEA implementation by working
closely with other agencies such as the Centers for Medicare & Medicaid
Services and Departments of Labor and Treasury, as well as the Office
of National Drug Control Policy. For instance, in partnership with the
Department of Labor, the HHS and SAMHSA developed new, free
informational resources that inform Americans of their rights under law
on coverage for mental health benefits. The following resources are
available on SAMHSA's website:
--``Know Your Rights: Parity for Mental Health and Substance Use
Disorder Benefits,'' an updated trifold pamphlet explaining
mental health parity, detailing what it means to the consumer,
and listing the protections the parity law provides.
--``Understanding Parity: A Guide to Resources for Families and
Caregivers,'' which provides an overview of parity geared
toward parents, family members or caregivers with information
and tools to help them obtain behavioral health services for
children or family members in their care.
--``The Essential Aspects of Parity: A Training Tool for
Policymakers,'' which provides state regulators and behavioral
health staff an overview of mental health and substance use
disorder parity and how to implement and comply with the
Federal parity law regarding employee-sponsored health plans
and group and individual health insurance.
We are committed to working with our Federal and state partners to
ensure that health plans and insurance companies are accountable for
delivering comprehensive care that includes protections on mental
health and substance use disorder parity. Non-compliance, both
intentional and unintentional, is a widespread problem, and additional
investments are needed to conduct enforcement activities on an
appropriate scale. While CMS has some enforcement authority, states are
the primary enforcers of mental health parity for health insurance
issuers in the small group and individual markets.
In the 2022 MHPAEA Report to Congress, the Departments of HHS,
Labor, and the Treasury (the Departments) highlighted their recent
emphasis on greater Mental Health Parity and Addiction Equity Act
(MHPAEA) enforcement and discussed the significant resources dedicated
to supporting these efforts. The Departments provided examples,
including how the Departments requested comparative analyses of plans'
and issuers' nonquantitative treatment limitations (NQTLs), which is a
process provided by the Consolidated Appropriations Act, 2021, and the
impact of the corrections.
In addition, HHS, together with the Departments of Labor and the
Treasury, intends to release additional rulemaking on the MHPAEA. There
have been a number of changes related to MHPAEA since issuance of the
final regulations, including the 21st Century Cures Act, the Substance
Use-Disorder Prevention that Promotes Opioid Recovery and Treatment
(SUPPORT) for Patients and Communities Act, and the Consolidated
Appropriations Act, 2021. This rule would propose amendments to the
2013 final rules (78 FR 68239) and incorporate examples and
modifications to account for this legislation and previously issued
guidance.
______
Questions Submitted by Senator Roy Blunt
Title 42
Question. Has the Department of Health and Human Services been
asked to provide or provided any vaccines to the Department of Homeland
Security for efforts to vaccinate illegal immigrants at the Southern
border?
If yes, how many?
Answer. No.
Question. If no, where is DHS procuring vaccines from and is it
from manufacturers directly? And if it is, is it part of a HHS
contract?
Answer. HHS defers to the Department of Homeland Security for
information on their procurements.
Question. On March 30, 2022, DHS released a Fact Sheet entitled DHS
Preparations for a Potential Increase in Migration. It states that
``DHS has also been providing the COVID-19 vaccines to noncitizens in
ICE custody since summer 2021.'' It goes on to state that ``Beginning
March 28, 2022, DHS expanded those efforts to cover migrants in CBP
custody, so as to further safeguard public health and ensure the safety
of border communities, the workforce, and migrants.'' What role is HHS
playing in this decision?
Has HHS provided any funding to support the mass vaccination of
illegal immigrants either in CBP or ICE custody?
Answer. HHS has allocated $48 million from CDC ARP funding via
Interagency Agreement with DHS to support certain vaccine related
services (e.g., vaccine event adverse reporting, inventory,
coordination with state/local Federal agencies) associated with DHS/
CBP's migrant vaccination programs.
Question. How many Public Health Service Corps members are
currently deployed to the Southern border?
Answer. Operation Artemis consisted of 71 unique missions, with a
total of 938 separate deployments occurring to support. A total of 805
unique officers deployed, with some officers deploying multiple times
to meet the 938 deployments.
Question. What are the costs associated with their deployment?
Answer. The average cost per officer to support a deployment is
$8000, totaling an estimated $7,504,000 to include officer travel, per
diem, rental vehicles, and miscellaneous expenses.
Question. What is their role and/or what mission are they
supporting?
Answer.
--USPHS deployed a flag officer, RADM Richard Childs, as the officer
in charge of Operation Artemis, due to the significance of the
operation and to ensure dedicated leadership personnel.
--Officers provided administrative support, facility and engineering
support, and clinical support on these deployments. Clinical
support included: COVID-testing, nursing case management, COVID
vaccination administration, general clinical evaluation and
care, pharmacological management, infectious disease support,
behavioral health management, and clinical coordination of
services across multiple agencies for unaccompanied children
and their families.
--Some of the roles in which officers were deployed to support these
missions included: Incident Commander, Site Lead, Chief Medical
Officer, Chief Nurse Officer, Safety Officer, Force Health
Protection, Nurse/Medical/Quality Control/Engineering/Pharmacy/
Mental Health Officers to name the most common.
Question. Are they providing vaccinations to illegal immigrants in
DHS custody?
Answer. Officers did provide vaccinations to unaccompanied children
to prevent the spread of COVID-19 and other communicable diseases.
Question. What is the policy for treating illegal immigrants in the
Department of Homeland Security's custody with COVID-19 therapeutics if
they test positive while in custody and what is HHS' role in this
activity?
Answer. CDC does not provide treatment or therapeutics for COVID-
19. CDC provides technical assistance and guidance to the Department of
Homeland Security to implement COVID-19 mitigation procedures in DHS
facilities. For more information regarding implementation of these
procedures, please contact DHS.
Aduhelm Decision
Question. In the last 7 years, this Subcommittee has written bills
that have more than quintupled funding for Alzheimer's research. That
is how critical of an issue it is to address. FDA has finally approved
a drug to treat mild-to-moderate Alzheimer's disease last year. But
last month, CMS made a historic decision to limit coverage only to
those participating in an NIH or FDA trial. And, interestingly, CMS
made a distinction between drugs approved through FDA's traditional
drug approval process and those that receive accelerated approval. I
don't believe that this distinction has ever been applied to a FDA-
approved treatment before.
I recognize that there is a lot of controversy around Aduhelm, its
data, its price, and potentially its approval. But putting that aside,
I am concerned that CMS, and ultimately HHS, has made a critical error
by making a coverage decision that affects not only
Aduhelm, but all other monoclonal antibody treatments coming down
the pike. Further, the decision calls into question FDA's entire
accelerated approval process and by doing so, clearly undermines the
scientific decisions made by FDA. Can you address what this CMS
decision means for the future of FDA's accelerated approval process?
Answer. The agency is committed to using expedited programs to
bring medicines to underserved populations with serious conditions and
unmet medical need when the science supports the decision within the
statutory authorities given to FDA by Congress. Our decision regarding
Aduhelm exemplifies that commitment. It is important to distinguish
between FDA's and CMS' role. The standard for Medicare coverage is not
the same as the standards for FDA approval of a drug. Our role is to
determine if drug is safe and effective. The agency cannot speak for
CMS. We continue to see sponsors pursue accelerated approval.
Ensuring the availability of innovative interventions for people is
a shared priority for both the Centers for Medicare & Medicaid Services
(CMS) and the U.S. Food and Drug Administration (FDA). Underpinning
both agencies' work is the unwavering commitment to use reliable data
to ensure that effective treatments are made available to patients. The
FDA's decision to approve a new medical product is based on a careful
evaluation of the available data and a determination that the medical
product is safe and effective for its intended use. CMS can conduct its
own independent review to determine whether an item or service should
be covered nationally by Medicare, including examining whether it is
reasonable and necessary for use in the Medicare population.
The final National Coverage Determination (NCD) ensures access to
and coverage for Aduhelm and other drugs in the antiamyloid monoclonal
antibody class that receive accelerated approval. The decision also
supports innovation and certainty of coverage by creating a long-term
coverage pathway for new drugs in this class that obtain FDA
traditional approval, without requiring a new NCD.
The work of both agencies is critical to ensure that medical
products are available to people across the country. We recognize the
impact these decisions have on people with serious and life-threatening
conditions and their loved ones. We share a common goal of wanting to
advance the development and availability of innovative medical
products. The agencies remain committed to using our distinct set of
authorities to ensure the continued availability of medical products
that meet our respective standards to care for the people we serve.
In issuing this NCD, HHS is not making any statement about coverage
of accelerated approval drugs. This decision is specific to the
antiamyloid monoclonal antibody class of drugs. HHS looks forward to
continuing our work on the innovative Cancer Moonshot initiative. All
Americans are invited to share perspectives and ideas, and
organizations, companies, and institutions to share actions they plan
to take as part of this mission at whitehouse.gov/cancermoonshot.
Question. How does the decision on Aduhelm affect other Alzheimer's
monoclonal antibody therapies that are under development?
Answer. NIH notes that the decisions issued by the FDA and Centers
for Medicare & Medicaid Services (CMS) are regulatory decisions, and
NIH defers to these agencies on such matters.
Supply Chain
Question. What is the Department's plan for investing in supply
chain resiliency for active pharmaceutical ingredients (API),
particularly those for essential medicines?
Answer. The HHS Office of the Assistant Secretary for Preparedness
and Response (ASPR) made a $354 million investment in Phlow, a
consortium of organizations that will expand domestic manufacturing of
raw materials and active pharmaceutical ingredients for drugs. This
effort includes support for continuous manufacturing. The efforts will
target drugs on the FDA drug shortage list that have become even more
critical during the COVID-19 response. I will be happy to keep you and
your staff informed of activities related to this initiative.
Question. Is the Administration leveraging existing manufacturers
and their ability to expand US capacity in the short term (i.e., within
1-2 years)?
Answer. With our initial award to PHLOW, we immediately began
supporting efforts to enhance domestic capacity immediately.
In addition, we have been supporting efforts to strengthen the
overall domestic manufacturing base to ensure we are better positioned
and prepared for whatever comes next. Within HHS/ASPR, we are working
to institutionalize efforts to support domestic manufacturing efforts.
Specifically, we are integrating and organizing supply chain
situational awareness and industrial analysis, domestic industrial base
expansion, and supply chain logistics. Bringing these pieces together
will strengthen our industry partnerships and support our work to
establish and maintain resilient supply chains. A new office within
ASPR will pull together several lines of effort across--PPE, Durable
Medical Equipment, Testing and Diagnostics, API, etc. While the new
office won't necessarily manage every program within that space--SNS,
BARDA and H-CORE will continue in key roles--the new office will be a
driving force in ensuring coordination of ASPR's efforts to expand the
industrial base and solidify the nation's supply chains.
Question. How much funding has been obligated or committed for this
activity?
Answer. Specific to the Phlow contract, an initial award of $354
million was issued. Phlow is a consortium of organizations that will
expand domestic manufacturing of raw materials and active
pharmaceutical ingredients for drugs.
Question. Does the current investment include a plan for warm based
manufacturing capabilities and a vendor managed model that would allow
for these newly manufactured APIs to support the underlying healthcare
marketplace both during and outside of public health emergencies?
Answer. Current investments are focused on generating highly
distributed continuous manufacturing capacities for APIs and finished
drug products allowing the U.S. to build resilient supply chains for
drug substances and drug products, both during and outside of public
health emergencies.
COVID-19 Education Campaign
Question. The HHS congressional justification references a
commitment to use local broadcasters and local newspapers for the
COVID-19 education campaign, but does not provide additional details on
how the Department will do so. What steps will the Department take to
ensure that local broadcasters and newspapers, especially in small and
rural communities, play a role in the ongoing educational campaign on
COVID-19?
Answer. Since onset, the Campaign has committed to using local
broadcasters and local newspapers to supplement broad-reaching national
outreach. Doing so has allowed for consistent surround-sound presence
to adults across America, with a layer of focused messaging directed to
the critical audiences. How the campaign has executed local media buys
to reach Americans where they live and from the channels they trust
most:
The Campaign greatly prioritizes placing paid advertising via local
media outlets, and specifically on local television, local cable, local
radio, local newspapers and local websites. These run consistently in
20+ markets per month (in some months up to 100 markets) directed to
different Campaign audiences.
These local buys run as a supplement to the Campaign's foundation
of national ads on broadcast and cable television (and sometimes
national radio).
Importantly, national, and local media outlets that are at least 50
percent owned by Minorities are prioritized, provided they provide
efficient outreach and are qualitatively suitable for Campaign
messages.
As one example, the Campaign designed a hyper-local campaign to
reach Black and Hispanic residents of Milwaukee, WI with an invitation
to visit a regional Community Vaccine Clinic. The four-week buy
included ads on:
--Radio: WJMR-FM (Urban Adult Contemporary), WNOV-AM/FM (Urban/Talk/
Community) WKKV-FM-(Urban Contemporary) WJYI-FM-(Contemporary
Christian/Christian preaching), WDDW-AM/FM (Regional Mexican)
and WJTI-FM (Regional Mexican)
--Print: Milwaukee Community Journal, Milwaukee Courier, Milwaukee
Times, Journal Sentinel Community NOW papers (targeted to
specific zip codes), Urban Milwaukee, El Conquistador, Hispanic
Reflections, Spanish Journal, La Comunidad News.
--OOH: Hyper-local poster boards within highly populated B/AA and
Hispanic communities and zip codes. Highly visible billboards
on heavy traveled roads and highways. Mobile targeted ads, geo-
targeted around vaccine clinic(s). DOOH (malls, office
buildings, gas stations, fitness centers, etc.)
--Digital: Urbanmilwaukee.com, sherpardexpress.com, Onmilwaukee.com,
bizjournal.com, milwaukeens.com for programmatic placements.
Site direct partners i.e. Nextdoor.
--Social: Facebook, Instagram, Twitter (geotargeted to Milwaukee
metro area)
--SEM: Google, Bing, Yahoo, Duck Duck Go (geotargeted to Milwaukee
metro area)
In order to continue to ensure that local broadcasters and
newspapers, especially in small and rural communities, play a role in
the ongoing educational campaign on COVID-19, it is critical to keep
Campaign messages in very local programming (including news, regional
entertainment and sports):
The campaign has made a dedicated effort to invest paid media
dollars in media channels that are located in and trusted by rural
populations. The ``We Can Do This'' campaign has had a dedicated rural
audience effort with tailored creative and media buys across efforts to
increase first doses for ``movable middle'' adults, parents with
unvaccinated children, and encouraging booster doses.
In addressing rural audiences, the campaign has focused on the more
than 46 million Americans who live in ``micropolitan'' or ``noncore''
counties according to the National Center for Health Statistics 2013
Urban-Rural classification scheme. On a monthly basis, the campaign has
identified heavy-up markets for additional local media purchases, and
concentrations of population in the media market that reside in rural
counties has been a factor when determining audiences.
Percentage of the paid budget spent on local paid--ideally compared to
industry benchmarks
--Of the Campaign's entire budget, approximately 70 percent is
allocated to the placement of paid advertising. More than half
of these dollars (51 percent) are directed locally in one of
two ways, either through direct purchase of space with
community media outlets or through national channels' reach
into specific locations.
In addition to collaborating with thousands of local media outlets
to run paid advertising, we have also engaged in partnerships and
relationships with community-based organizations. Many of the
organizations with whom we work allow us to affect hyper-local, highly
vulnerable populations who may not otherwise be reached with critical
information about how, where, and why to get vaccinated. For example,
we're working with:
--National PTA activating 34 local PTAs in priority markets to host
events and conduct outreach to parents of children eligible to
get vaccinated. Since the start of the partnership, PTA has
conducted a total of 86 pop-up vaccine clinics and vaccinated
(first shot or booster) 2,050 people.
--The Cobb Institute of the National Medical Association has been
hosting a series of ``Stay Well Community Health Fair and
Vaccine'' events in priority markets targeted at reaching Black
and African American families. Since the start of the
partnership, they have hosted sixteen events, 1,475 individuals
have been vaccinated or been given booster shots at these
events.
--Eighteen Asian American, Native Hawaiian, and Pacific Islander
organizations across the country to conduct in-person and
digital outreach. From November 2021 to June 2022, we reached
over 3,000,000 people. Some of the organizations include, The
Asian American Pacific Community Health Organization, Asian and
Pacific Islander Vote, and The National Association of Pasifika
Organizations.
--In partnership with Copa Univision, we attended a community sport
event in Dallas, TX on June 4-5, to share COVID-19 information
with over 800 Latino families participating at the amateur
soccer event. The Campaign will participate in three other Copa
Univision events in Houston, Chicago, and New York.
--National Day Laborer Organizing Network (NDLON) has been reaching
migrant workers and farm workers with key information about
vaccines through in-person events and radio. The organizations
will also share new videos produced in five different
indigenous languages.
--Vaccine Hunters distributed 2,274 Campaign materials at six
canvassing sites and hosted 48 vaccination clinics in Maryland
to reach Spanish-speaking Latino people. The organization has
already vaccinated 2,426 people.
--Working with the National Diaper Bank and Alliance for Period
Supplies to distribute campaign information among 200 local
banks across the country. These will include fact sheets,
drafted press release, postcards, and other materials in diaper
and period supply boxes.
--The United Methodist Health Ministry Fun posted seven video
testimonials reaching an online audience of more than 200,000
and hosted a webinar for 82 Kansas faith-based, healthcare and
childcare providers as well as published an op-ed in Topeka
reaching more than 31,000 print and 500,000 online subscribers.
--The National Rural Education Association created three video
testimonials with teachers from Missouri, Iowa and Northern
California reaching more than 50,000 online viewers; shared
information with 300 educators in Victoria, TX at a state
conference; published a podcast with a pediatrician from West
Virginia with 3,400 downloads; and published a social media
toolkit and newsletter for their national network of rural
educators and state directors with a reach of more than
100,000.
Question. Please provide details on obligations to date to local
broadcasters and newspapers for education campaigns from both the
COVID-19 supplemental funds and the American Rescue Plan, broken out by
bill, year, and agency.
Answer.
Fiscal Year 2020
Local Radio............................................. $8,512,770
---------------
Fiscal Year 2020 Total.............................. $8,512,770
Fiscal Year 2020--Funding Source
IAA with the CDC funded by CARES Act appropriation
to CDC, Public Law 116-136, 134 Stat. 281, 554-55.
Fiscal Year 2021
Local Newspapers........................................ $11,136,940
Local Radio............................................. $14, 526,430
Local Television........................................ $4,428,756
---------------
Fiscal Year 2021 Total.............................. $30,092,126
Fiscal Year 2021--Funding Source
CARES Act appropriation to CDC, Public Law 116-136,
134 Stat. 281, 554-55.
American Rescue Plan (ARP) Public Law 117-002.
Fiscal Year 2022
Local Newspapers........................................ $7,482,218
Local Radio............................................. $14,916,933
Local Television........................................ $11,082,786
---------------
Fiscal Year 2022 Total.............................. $33,481,938
Fiscal Year 2022--Funding source
CARES Act appropriation to CDC, CARES Act, div. B,
title VIII, Public Law 116-136, 134 Stat. 281, 554-
55.
American Rescue Plan (ARP) Public Law 117-002.
HRSA Poison Control
Question. I remain concerned that the Department has failed to
address the issue of misdirected calls to poison control centers, as
required under the Poison Center Enhancement Act that passed in 2019 as
part of the fiscal year 2020 appropriations bill. It is my
understanding that poison centers in 12 states and the District of
Columbia have more than 10 percent of their calls misrouted to the
wrong poison center. Critical medical treatment can be delayed when
this occurs.
The Poison Center Enhancement Act requires the Secretary of HHS to
coordinate with the FCC within 18 months of enactment to ensure calls
are routed to the proper poison center based on the location of the
caller to the ``extent technically and economically feasible.'' From
what I can tell little progress has been made on this issue. Please
provide an update on this issue, as well as a plan of action to
improve, if not solve, this growing problem.
Answer. HRSA recognizes the importance of proper routing of the
Poison Help Line calls.
HRSA is engaging with our internal and external partners to
identify technologically feasible solutions to address the longstanding
issue associated with caller's area codes versus geographical location
being used for call routing. We are currently engaged with Verizon (the
toll-free vendor), an industry technology solutions organization
(ATIS), the American Association of Poison Control Center (AAPCC), and
FCC to identify potential technology-based solutions to the call
routing issue. Verizon has submitted a formal issue statement to ATIS
to initiate an industry review of potential methods to improve the
routing information wireless providers over 4G mobile networks; this
issue statement was accepted by ATIS and is currently under review.
HRSA also conducted individual calls with several vendors to further
stimulate telecommunication contractors to propose solutions.
We are committed to continuing to work with industry on a solution
to this important issue.
COVID-19 Commercialization
Question. Products are able to go into the commercial market once
they receive FDA approval. For COVID-19 related products that have FDA
approval, like COVID-19 vaccines for adults, when will the Department
transition from being the sole purchaser of these products?
Answer. To date in the COVID-19 response, HHS has supported efforts
to ensure that vaccines are available to all states and communities. As
of April 1, 2022, HHS has procured approximately 2 billion doses of
vaccine and 10.4 million therapeutics and has provided these resources
to states and territories at no cost. As Congress has not provided the
resources requested for these efforts, the Department is thinking
through courses of action to manage the transition away from Federal
acquisition. There are a number of potential issues that need to be
considered related to licensure, access, and coverage, which may
require possible statutory or regulatory changes to resolve. Additional
funding is required to ensure that there is a smooth transition and
that challenges are addressed as we move forward with shifting vaccines
to the commercial market.
COVID-19 Tests
Question. What is the Department's funding plan for COVID-19
testing manufacturers?
Answer. The Administration has been working closely with domestic
suppliers and manufacturers since the very beginning. From its first
days in office, the Administration has used the Defense Production Act
(DPA), industrial mobilization, and advance market commitments to
accelerate production of tests. The Administration has also invested
billions of dollars in industrial base expansion and procurement of a
large quantity of tests from a variety of domestic manufacturers,
including Abbott, Quidel, Orasure, and others, as part of the
COVIDTest.Gov initiative, and other testing initiatives. We also
continue to find ways to maximize any level of support we can provide,
including through existing contracts for tests for Long-Term Care
Facilities, federally Qualified Health Centers, other Community Health
Centers, food banks, and schools. However, as we have been saying for
the past months, we need the additional requested funding to provide
ongoing support and avoid further production cuts and job layoffs
during this time. Without additional funding, there are risks that we
will not have the testing capacity we need during a future surge.
Question. Earlier this year, the Department purchased 1 billion at-
home tests to be distributed to Americans. The majority of those tests
were purchased from Chinese manufacturers. Should a spike in cases
cause the Department to purchase additional at-home tests, is there a
plan in place to make these purchases from domestic manufacturers?
Why were domestic manufacturers not used for the 1 billion at-home
tests the Administration purchased in January 2022?
Answer. When the Administration began offering COVID-19 tests, at
no cost, to any person who requested such tests, the intention was to
increase the number of tests available without impacting the supply of
tests in the commercial market and without impairing existing state/
territorial contracts for the procurement of tests. However, from
November 2021 to February 2022, we saw a strained domestic
manufacturing and supply chain for COVID-19 tests due to an increase in
cases. During this timeframe, domestic capacity was not large enough to
produce the number of tests required to achieve this initiative. To
avoid further straining the domestic market and to further increase
access to free tests for the American public, the Administration made
the decision to purchase tests from international manufacturers for the
larger test initiative. Since the market has stabilized, the
Administration has once again shifted to purchasing domestic tests. Our
goal is to continue to prioritize the purchase of tests domestically,
but we must continue to provide stability and predictability to the
domestic market.
Question. As of May 4, testing companies have not received
additional volume commitments, but have been provided guidance from the
Department to ramp up to maximum capacity. Will these domestic
manufacturers receive a concrete order from the Department?
Answer. As we have been saying for the past months, we need the
additional requested funding to be able to provide ongoing support to
domestic manufacturers in order to avoid production cuts and job
layoffs. We have already heard from companies that they have reduced
their production capacity by as much as 85 percent compared with
maximum production capacity and laid off thousands of workers. We need
the additional requested funding from Congress to avoid further
reductions and ensure we have sufficient testing supply and capacity in
the event of another surge.
Question. What is the Department's plan for warm-basing domestic
testing manufacturing?
Answer. The ability of manufacturers to continue to produce at high
levels requires a commitment by the Federal government. Tests purchased
by consumers on the retail market tend to ebb and flow as cases rise
and fall. Given this, the Federal Government serves as the only real
backstop that can guarantee purchases for domestic manufacturers. The
Administration will continue to emphasize the need for Congress to
provide the requested funding for these purposes. Our inability to fund
warm basing within domestic testing manufacturing risks us not having
the testing capacity we need in the event of a fall or winter surge.
988 and Behavioral Health Crisis Services
Question. The Substance Abuse and Mental Health Services
Administration (SAMHSA) submitted the ``Report to Congress on 988
Resources'' (Report to Congress), which was required by the National
Suicide Hotline Designation Act of 2020, more than 8 months after it
was due. The new three-digit lifeline is set to launch in July this
year, and the budget requests an increase of nearly $600 million for
fiscal year 2023. SAMHSA has known about the July 2022 launch date for
some time, yet SAMHSA's delay puts Congress in a difficult position to
provide a fivefold increase or else appear to shortchange this critical
effort. Further, the fiscal year 2023 funding will not be available for
988 for months after the launch, and that is a best case scenario.
While the Report to Congress outlines projected annual resources to
sustain 988, the fiscal year 2023 budget does not provide any detail as
to how SAMHSA would allocate $696.9 million. While appreciated, the
Report to Congress is not a budget document. Please provide a breakout
of funding for the fiscal year 2023 request and a detailed description
of each activity for the 988 and Behavioral Health Crisis Services,
along with the allocation method for each activity.
Answer. First, it is important to note that July 2022 and the
transition to 988 and the impacts on volume are as yet unknown. SAMHSA
is projecting resource needs based upon the best available current
data, and will continue to provide ongoing assessments to respond to
potential alternate scenarios. These ongoing assessments may alter
projected resource needs outlined below.
The fiscal year 2023 Budget Request for 988 and Behavioral Health
Crisis Services is $696.9 million. The budget proposes an historic
investment in the 988 program to ensure there is sufficient funding to
support crisis response. The proposed funding will play an essential
role in advancing the crisis system to meet the once-in-a lifetime
opportunity of 988 by:
Increasing crisis center capacity ($545 million): This funding will
enhance local capacity through partnerships in behavioral health crisis
response--Local center capacity is critical to ensuring that
individuals in crisis receive responses that are tailored to the
service system where they are located and that services across the
continuum are linked and coordinated. We expect the greatest resource
needs in supporting 988 response across the national crisis back up
centers (Federal) and local crisis centers (combined Federal and non-
Federal). SAMHSA's budget projections are based on volume expectations
at an $82 cost per contact and volume estimates that project 7.6
million contacts in fiscal year 2023. Given current estimates of local
capacity and non-Federal funding sources to support local response,
SAMHSA expects a Federal resource need of $545 million. This funding
shores up our crisis centers around the country to ensure that they
have the ready workforce available to staff and answer calls, chats and
texts for help and strengthens partnerships that decrease law
enforcement response to individuals in crisis.
Strengthening network operations ($117 million): As the network
continues to scale, additional funding will be required for the
Lifeline administrator and centralized network functions, including
data and telephony infrastructure; standards, training, and quality
improvement; evaluation and oversight.
Funding will also be required to sustain and expand technology to
promote access for marginalized populations. The fiscal year 2023
investment further increases the capacity and performance of these key
network infrastructure components and functions to the standard
required for the projected contacts anticipated in fiscal year 2023 and
support collaborative efforts with partner organizations to improve
local routing of contacts.
Sustaining the 988 & Behavioral Health Crisis Coordination Office
($10 million): The 988 transition will require continued extensive
coordination at the Federal, state, and local levels. Coordination
activities led at a Federal level include technical assistance to
states, and crisis centers; strategic planning, performance management,
evaluation, and oversight; and formal partnerships, convenings, and
cross-entity coordination.
Supporting public awareness with targeted 988 national messaging
($25 million): The 988 code will provide a universal, easy-to-remember,
three-digit phone number and connect people in crisis with life- saving
resources. As 988 is implemented, SAMHSA anticipates the need and
additional costs to educate the public on services covered by 988, and
the differences between 988 and 911. This funding would permit
continuation of focused work on populations known to be at high risk of
suicide, building upon formative research processes that were launched
in fiscal year 22. This funding is not for a larger scale public
awareness campaign, but is targeted, foundational work needed to
educate the public and local communities on the function of 988.
Question. The Report to Congress indicates that $560 million would
be needed to strengthen local crisis call center capacity from Federal
and non-Federal funding. How does the budget request account for non-
Federal resources? Please provide an estimate and description of non-
Federal resources.
Answer. SAMHSA is working with its partners to track state-level
legislative and non-legislative activity aimed at supporting local
crisis capacity. To date, only four states have passed legislation with
corresponding 988 state cell phone fees, including Colorado, Nevada,
Washington, and Virginia. Other states have passed appropriation
legislation not connected to cell phone fees, some have ordered
commissions without any specific funding allocation, and many states
have either legislation in progress or no current plans for legislative
activity. Some states have also looked to Medicaid and payer
reimbursement to support crisis center development though this is in
very early stages in most areas. SAMHSA expects that it will take time
for most states to develop sustainable and comprehensive mechanisms to
support 988.
Organ Procurement and Transplantation Accountability
Question. The HHS budget documents appear to be sending a mixed
message with regard to the Administration's position on holding Organ
Procurement Organizations (OPOs) accountable for poor performance. The
fiscal year 2023 HHS Budget in Brief document includes a section called
``Remove Restrictions on the Certification of New Entities as Organ
Procurement Organizations and Increase Enforcement Flexibility,'' which
proposes flexibility to recertify poor performing OPOs that lose
certification because of failure to meet certain criteria. This
narrative runs counter to the Final rule ``Organ Procurement
Organizations Conditions for Coverage: Revisions to the Outcome Measure
Requirements for Organ Procurement Organizations'' (42 CFR Part 486),
which will bring much needed standardization to how OPOs measure
performance and ensure all OPOs are performing at high quality
standards. What is intended by this budget narrative and why is it
proposed in light of the Final rule 42 CFR Part 486?
What is the status of implementation of 42 CFR Part 486 and what
guidance has CMS provided to OPOs regarding its implementation?
Answer. Organ procurement organizations (OPOs) are vital partners
in the procurement, distribution, and transplantation of human organs
in a safe and equitable manner for all potential transplant recipients.
The role of OPOs is critical to ensuring that the maximum possible
number of transplantable human organs is available to individuals with
organ failure who are on a waiting list for an organ transplant. HHS is
dedicated to improving health equity and access in the organ
procurement and transplantation system, including by holding OPOs
accountable for their performance.
In December 2020, CMS published ``Medicare and Medicaid Programs;
Organ Procurement Organizations Conditions for Coverage: Revisions to
the Outcome Measure Requirements for Organ Procurement Organizations''.
This rule finalized new outcome measures OPOs are required to meet for
re-certification and was published with the intention of increasing
donation and organ transplantation rates by replacing the previous
outcome measures with new transparent, reliable, and objective outcome
measures that are used to make better certification decisions and
incentivize better performance. At the end of the re-certification
cycle, each OPO will be assigned a tier ranking based on its
performance for both the donation rate and transplantation rate
measures, as well as the re-certification survey. The highest
performing OPOs will be assigned in Tier 1 which means the donation and
transplantation rates of the top 25 percent of OPOs, and automatically
recertified for another 4 years. OPOs with rates that are below the top
25 percent will be in either Tier 2 or 3. Tier 2 OPOs are not
automatically recertified but they will have to compete to retain their
donation service area (DSA). Tier 3 OPOs are the lowest performing OPOs
and will be decertified and lose their service area. CMS believes that
increasing competition between the OPOs will incentivize them to
maximize their performance and consequently increase the number of
organs available for transplantation.
OPOs will be held accountable for the new measures for
recertification purposes in 2026. While CMS will conduct activities for
OPO recertification in 2026, the timeline for OPOs to implement needed
improvements occurs much earlier than 2026. OPOs will be notified of
their performance on the new outcome measures at the end of each 12-
month period of the 4-year recertification cycle, which starts in 2022.
OPOs will be accountable to this requirement when they receive their
first results in the next re-certification period. The target data for
this first report is spring of 2023. By identifying the performance of
OPOs annually, poor performing OPOs can appropriately change and adopt
effective practices that improve their performance in donation and make
more organs available for transplantation.
The President's fiscal year 2023 Budget includes a proposal that
would certify new entities as organ procurement organizations and
recertify certain organ procurement organizations that do not meet the
criteria for recertification based on outcome measure performance, but
which have shown significant improvement during a re-certification
cycle. The proposal will provide the flexibility CMS needs to avoid
organ procurement disruptions due to the certification status of
certain organ procurement organizations and provide these organizations
with an incentivize to maximize performance even if they do not believe
they could satisfy the outcome requirements at the next
recertification.
Question. I was pleased to see HRSA released a Request for
Information regarding the Organ Procurement and Transplantation Network
(OPTN), seeking ways to improve and strengthen the OPTN ahead of the
fiscal year 2023 Request for Proposal. Throughout the last 4 years, the
OPTN contractor United Network for Organ Sharing (UNOS) has been
exposed for its regional bias and inability to effectively improve the
organ procurement and transplantation system. For example, records that
UNOS fought vigorously to keep hidden from the public reveal UNOS
colluded against certain regions of the country when it issued the
liver allocation policy in December 2018. Further the National
Academies of Science, Engineering, and Medicine (NASEM) revealed an
astounding number of organs continue to unused, and NASEM made several
recommendations related to the OPTN contract and HHS oversight to
improve accountability, improve policymaking, and modernize the
transplantation network. How is HHS planning to update the OPTN
contract to hold the contractor accountable for system improvements?
Will HHS break up the OPTN contract to separate the policymaking
functions from the IT functions?
Answer. HRSA recognizes that the Organ Procurement and
Transplantation Network (OPTN) contract is critical to the oversight
and accountability of the organ donation and transplantation system and
intends to be appropriately deliberative about decisions impacting the
effectiveness and efficiency of the system. As you note, HRSA issued a
Request for Information (RFI) to solicit feedback about opportunities
to strengthen the OPTN. In particular, the RFI sought feedback on the
ways to address many of the National Academies of Science, Engineering,
and Medicine findings and recommendations in its report titled
Realizing the Promise of Equity in the Organ Transplantation System.
HRSA released the RFI to better support HRSA's efforts to increase
accountability in OPTN operations, modernize performance of the OPTN IT
system and related tools, and improve engagement with donors and
patients. It specifically focuses on opportunities to strengthen
equity, access, and transparency in the organ donation, allocation,
procurement, and transplantation process. In addition, it also sought
stakeholder input on the governance, finance, IT, data collection,
policy, and operational components of the OPTN. HRSA is appreciative of
the response to the RFI and is actively reviewing this important
feedback to inform the development of the next contracting cycle. We
look forward to continuing to engage with Congress as we develop the
next contracting cycle and continue to identify strategies for
modernization and accountability across the organ procurement and
transplantation system.
Provider Relief Fund (PRF)
Question. Hospitals and providers that opened their doors in 2020
and 2021 have not had equitable access to the PRF, despite experiencing
some of the same challenges during the COVID-19 pandemic as established
healthcare providers. What has the Administration done to ensure
equitable access to the PRF dollars Congress provided for this subset
of providers?
Answer. As part of the Administration's ongoing commitment to
equity, and to support providers with the most need, HHS included new
elements in Phase 4 of the Provider Relief Fund (PRF). Rather than
paying the same percentage of losses for all providers as in Phase 3,
PRF Phase 4 reimburses smaller providers for their operating revenues
net expenses at a higher rate compared to larger providers. That means,
new providers who just opened their doors and have $10 million or less
in annual patient care revenues in 2020 would receive 45 percent of
their adjusted quarterly losses, compared to 25 percent or 10 percent
for medium and large providers.
In addition, HHS allocated approximately 25 percent of the $17
billion allocation to Phase 4 Bonus payments based on the amount and
type of services to Medicare, Medicaid, and Children's Health Insurance
Program (CHIP) patients. HHS used a similar methodology for the $8.5
billion in ARP Rural payments, making payments based on the amount and
type of services provided to Medicare, Medicaid, and CHIP patients who
live in rural areas, as defined by the Federal Office of Rural Health
Policy. Bonus payments relied on claims submitted from January 1, 2019
through September 30, 2020 in order to capture both pre-pandemic care,
as well as care delivered during the pandemic. This allowed providers
that opened their doors in the first three quarters of CY 2020 to be
eligible for additional funds.
Question. How many hospitals and healthcare providers opened their
doors in 2020, 2021, or 2022? Can HHS please provide a breakout by
provider type, year, and an estimate of the emergency relief funding
that these providers have requested and received from the PRF?
Answer. Attached, please find the Phase 3 and Phase 4/ARP Rural
payments to new provider in 2020 by self-selected provider type.
Please note, new providers in 2021 and 2022 were not eligible for
PRF or ARP Rural payments. Furthermore, the application portals for
Phase 3 and Phase 4/ARP Rural did not collect providers' emergency
funding requests. The data attached are Quarterly Losses, which are
calculated based on changes in operating revenues and expenses pre-
pandemic and COVID-19, as reported by applicants. For new providers
where there is no comparable pre-pandemic time period, the revenue loss
was estimated using the revenues reported by the provider and the
average loss rate for that category of provider.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Substance Use Harm Reduction
Question. Thank you for your prompt response to my letter in
February on HHS' harm reduction grant. As many in Congress were, I was
concerned that HHS was on the precipice of providing Federal funding to
purchase crack pipes. After the controversy that funding announcement
stirred up, what did HHS do to ensure these grants will not go toward
purchasing illegal drug paraphernalia, like syringes and crack pipes?
Answer. In the Notices of Award, SAMHSA included terms and
conditions explicitly restricting funds from directly or indirectly
purchasing or promoting the use of drug paraphrenia, including pipes/
pipettes in safer smoking kits. Syringes to prevent and control the
spread of infectious disease are allowed for purchase. Harm reduction
programs that use Federal funding must adhere to Federal, state, and
local laws, regulations, and other requirements related to such
programs or services. A comprehensive program monitoring and oversight
plan is being implemented to ensure that funds are not misused. Please
see the Notice of Funding Opportunity for more information: https://
www.samhsa.gov/sites/default/files/grants/pdf/fy22-harm-reduction-
nofo.pdf.
Question. Drug overdose trends are a cause for alarm. In my time as
the lead Republican on this Subcommittee, we have increased funding by
$4 billion toward addressing the opioid crisis, which suffered a
setback during the pandemic. There's no doubt we need to continue to
address this crisis. I'm concerned, however, with the push to expand
overdose prevention activities and similar harm reduction activities at
the expense of primary prevention activities. Since 2019, in a
bipartisan manner, this Subcommittee has explicitly funded harm
reduction activities through the Center for Substance Abuse Treatment.
This was done to not undercut programs that are focused on primary
prevention of substance use and to ensure people who suffer an overdose
have access to treatment, yet SAMHSA has blatantly ignored
Congressional intent. This willful disregard for Congressional intent
is inexcusable and a cause for concern. Why did SAMHSA continue to fund
the administration of ``Grants to Prevent Prescription Drug/Opioid
Overdose,'' ``First Responder Training for Opioid Overdose Reversal
Drugs,'' and ``Improving Access to Overdose Treatment'' out of the
Center for Substance Abuse Prevention, after Congress specifically
moved the programs to the Center for Substance Abuse Treatment in 2019?
Will you work with us to make sure both the administration and
funding for harm reduction activities align with congressional intent?
Answer. Since 2019 and up to the present time, SAMHSA has followed
Congressional guidance and funded PDOA, FRT, and IAOT out of CSAT.
However, in recognition that the most effective harm reduction
strategies are implemented across the *behavioral health continuum,
CSAP subject matter experts have been heavily involved in the
administration of these programs. This management approach has not been
implemented at the expense of SAMHSA's primary prevention efforts but
have enhanced the effectiveness of behavioral health services and
interventions across the continuum of care.
Unfortunately, traditional primary prevention programs are not
always effective in preventing substance misuse and/or overdose deaths.
CSAP programs that expand beyond primary prevention utilize data that
targets trends and themes associated with overdose deaths and increased
substance use. Including indicated and selective prevention activities
such as psychosocial supports in CSAP programs is critical to
connecting at risk individuals to support services and treatment
services that are funded by CSAT. Funding multiple types of prevention
programs that utilize evidence-based approaches saves lives.
SAMHSA's Behavioral Health Continuum:
Promotion: These strategies are designed to create environments and
conditions that support behavioral health and the ability of
individuals to withstand challenges. Promotion strategies also
reinforce the entire continuum of behavioral health services.
Prevention: Delivered prior to the onset of a disorder, these
interventions are intended to prevent or reduce the risk of developing
a behavioral health problem, such as underage alcohol use, prescription
drug misuse, and illicit drug use.
Treatment: These services are for people diagnosed with a substance
use or other behavioral health disorder.
Maintenance: These services support individuals' success and
include long-term treatment, continuing care, and recovery support.
Question. It has been reported that the Biden Administration is
considering support for safe injection sites. These sites allow drug
users to consume illicit drugs under medical supervision and are
against the law. The Associated Press reported in February that the
Department of Justice is ``talking to regulators about `appropriate
guardrails''' for such sites. What is the status of these discussions
and is HHS or SAMHSA involved?
What are the ``appropriate guardrails'' that are under discussion?
Answer. SAMHSA is not involved in safe injection sites. Given the
legal status, we have and continue to refrain from involvement.
Unaccompanied Children
Question. In fiscal year 2021, the Department had the largest
number of referrals of unaccompanied children ever. It spent almost $7
billion on the program, including almost $4 billion transferred from
funding that was supposed to be spent on COVID-19 activities. fiscal
year 2022 referrals to date are almost 40 percent higher than they were
at this time in fiscal year 2021, and Congress has provided $8 billion
to care for unaccompanied children this fiscal year. However, for
fiscal year 2023, the Administration only requested $4.9 billion in
discretionary funding for the program. Why do you think the Department
will be able to cut $3.1 billion in costs when referrals of UACs and
program costs have gone up the past 2 years?
Answer. The Administration requested a $4.9 billion discretionary
appropriation for fiscal year 2023 as well as two mandatory
appropriations. With the funding provided by the discretionary
appropriation, ACF will continue to effectively care for children
referred by the Department of Homeland Security (DHS), ensure
facilities meet FSA standards, and work to expand post-release services
to all children released from ORR care. The Budget also proposes
mandatory appropriations for a contingency fund, recognizing the
unpredictable fluctuations in program needs, and a fund for UC legal
representation. Additionally, the number of permanent shelter beds will
increase, reducing the amount of funding needed for more expensive
temporary shelter beds. Approximately 75 percent of budget costs go
directly to care for unaccompanied children (UC) in ORR shelters. Other
services for UC such as medical care and family unification services,
including background checks, make up approximately 20 percent of the
budget. Administrative expenses to carry out the program total
approximately 5 percent of the budget. The UC program will keep the
appropriations committees apprised of changes to program costs as
needed.
Question. As I mentioned in my opening statement, I'm concerned
about the impact of the termination of the Title 42 Order. Even though
unaccompanied children have been exempted from the order since January
2021, the Department of Homeland Security is projecting a large
increase in illegal border crossings which will likely include
unaccompanied children. What are your plans to handle a surge in UACs?
Can the program support a surge at the level requested in the
President's budget?
If not, why wouldn't you provide Congress with a budget request
that reflects the actual costs of the program?
Answer. ORR will continue to care for children referred by DHS and
ensure their safety and well-being. However, this program's costs are
inherently unpredictable and challenging to budget for with any degree
of certainty. Despite this uncertainty, we have an obligation to
provide appropriate services to all unaccompanied Children.
HHS's mission is to care for UC until they are safely released to a
vetted sponsor or leave ORR custody following an immigration judge's
order of removal, turn 18 years of age, or obtain legal immigration
status in the United States. The number of children referred by DHS in
ORR care can fluctuate, which is why ORR continuously reviews capacity
needs throughout the year.
These estimates are based on historic data and DHS predictions and
consider several factors such as UC referral numbers, trends,
projections, and COVID-19 infection rates and impact on staffing and
bed availability. These estimates further inform program costs in real-
time and impact budget numbers accordingly.
Because of the inherent uncertainty in the UC program, it is
extremely challenging to fund it through the conventional annual
appropriations process. For this reason, the 2023 Budget would
establish a mandatory contingency fund, which would provide additional
resources when there are unexpected surges in the number of
unaccompanied children requiring care.
HHS/ORR continuously plans for increases in migration. This
includes projecting influx capacity needs, expanding bed capacity,
adding more beds through entering into cooperative agreements with
existing grantees, and adding new grantees to ORR's network of
facilities. Associated program costs are included in the current budget
proposal before the committee. ACF maintains regular dialogue with the
appropriations committees and will continue to keep
Members and staff apprised of changes in funding needs.
Question. The budget proposes, again, a contingency fund for the
UAC program. This has never been an effective way to manage the
program, as witnessed in an fiscal year 2017 CR when the Democrats
forced the inclusion of $200 million in funding for a contingency fund,
its threshold trigger was set too high, and that funding was wasted.
Knowing that, why would the Department propose a contingency fund
again? It appears that it is simply a budget gimmick.
Answer. We do not view the contingency fund as a gimmick. Instead,
we view it as a reasonable way to deal with the inherent uncertainty in
the UC program, allowing the program to have a reliable source of
funding to activate new shelter capacity to handle unexpectedly high UC
referrals.
ACF analyzed the previous iteration of the contingency fund and
designed this proposal accordingly to be more effective and
operational. We concur that the threshold trigger in the fiscal year
2017 CR was set too high. ORR took that miscalculation into account and
designed the current proposal to be more efficient. Specifically, the
fund would pay out $27 million for each increment of 500 referrals
above a threshold of 7,500 UC referrals per a month, which is a
historically high level of monthly referrals.
______
Questions Submitted by Senator Richard C. Shelby
Question. Review Choice Demonstration for Inpatient Rehabilitation
Facility services
The inpatient rehabilitation facility review choice demonstration,
or IRF RCD, is slated to begin in Alabama at some point, perhaps later
this year. What steps has HHS/CMS taken to identify qualified auditors
who have experience caring for IRF patients, given the increased
auditing that will occur under IRF RCD? We have about 20 rehabilitation
hospitals and hospital-based inpatient rehabilitation units in Alabama,
and this IRF RCD program is going to be a big challenge for them. Will
HHS/CMS commit to collaborate with them so that the RCD doesn't become
an overwhelming burden of paperwork and claim denials? If so, what
actions will the Department and agency take to minimize the
administrative burden and promote access to care?
Answer. The proposed Inpatient Rehabilitation Facility (IRF) Review
Choice Demonstration (RCD) would allow the agency to better understand
the scope and causes of improper payments and work with IRFs to reduce
documentation errors. This would allow CMS to focus on the prevention
of improper or fraudulent IRF claims and assist in developing improved
procedures for the identification, investigation, and prosecution of
Medicare fraud occurring among IRFs providing services to Medicare
beneficiaries. Additionally, the proposed IRF RCD would offer IRFs
provisional assurance of payment and would reduce the burden of audits
and associated appeals while protecting beneficiary access to care in a
timely manner.
This proposed demonstration would not create new clinical
documentation requirements; rather, it would only require submission of
the same information providers are currently required to maintain. IRFs
would have flexibility as they can choose their path to demonstrate
compliance with Medicare requirements. IRFs would initially select, for
the first 6 months, between two review choices: 100 percent pre-claim
review or 100 percent post payment review. Providers who select pre-
claim review may resolve any documentation issues and resubmit their
requests an unlimited number of times prior to submitting the claim for
payment. IRFs that have a high pre-claim review affirmation rate or
post payment review claim approval rate would have additional options
from which to choose, including relief from most reviews which will
offer providers the flexibility to choose a review option that would
work for them based on their resources and financial needs. No matter
which choice is selected, beneficiary access to treatment will not be
delayed.
To ensure consistency in operations and to eliminate potential
contractor variation in medical review, we will ensure there is
vigorous oversight of demonstration operations, including quality
assurance and accuracy reviews of Medicare Administrative Contractor
(MAC) review decisions to ensure they are reviewing in accordance with
CMS policies. The MAC reviewers will undergo training to ensure
consistency before beginning the reviews. The MACs involved in the
demonstration regularly perform Medicare reviews on behalf of CMS and
will be following all applicable statutes and regulations that are in
effect when the demonstration is implemented. Both the MAC and CMS will
monitor the reviewers' accuracy throughout the demonstration. In
addition, CMS medical staff will conduct reviews on a selection of pre-
claim review requests and claims to ensure the MAC decisions are
accurate and consistent across reviewers.
______
Questions Submitted by Senator Jerry Moran
Question. Mr. Secretary, Congress has provided bipartisan support
to help extend the reach of state and Federal programs to serve more
families and improve the overall quality of care. I was pleased to
support significant funding increases for the Child Care Development
Block Grant and Head Start in particular in the fiscal year 2022
omnibus. I am also a cosponsor of the Child Care and Development Block
Grant Reauthorization Act of 2022, which would build on the bipartisan
Child Care and Development Block Grant program to provide greater
support to working families to afford child care.
Can you please speak to how additional funding for CCDBG will help
low- and middle-income families be able to continue to access and
afford high- quality child care?
Answer. In fiscal year 2020, the CCDF program served 1.49 million
children and 900,300 families despite minimal or even inadequate
funding. The number of children served has steadily declined over the
last decade from a high of 1.7 million children in fiscal year 2010.
Only about 15 percent of federally eligible children receive child care
subsidies. Moreover, almost all states establish child care provider
payment rates that fail to reimburse providers for the full cost of
quality child care, which reduces parent choice, inhibits supply, and
contributes to high staff turnover and low wages. In turn, states are
forced to limit eligibility, enforce waitlists, charge unaffordable
family co-payments, and establish payment rates that fail to reimburse
providers for the full cost of quality child care. CCDF needs
significantly more resources to ensure that additional families have
access to child care, improvethe quality of care, increase wages, and
strengthen the child care sector.
Question. During the Senate Appropriations Subcommittee hearing on
May 4th, you committed to fully stocking the biodefense and pandemic
response supplies maintained by the Strategic National Stockpile. It is
also imperative that the Stockpile is maintained with products
manufactured in the U.S. and not depend on China as we did when COVID-
19 first arose. I'm troubled to learn that HHS has cancelled 3
contracts to manufacture gowns for the Strategic National Stockpile in
the past 6 months. We've also been told there are currently zero
sterile surgical gowns in the Stockpile. However, your fiscal year 2023
budget does note that you have a target of 265M gowns and that
procurements are in process.
Can you confirm for me specifically how many sterile surgical gowns
are currently in the Strategic National Stockpile and what are your
plans to procure additional U.S.-made sterile surgical gowns to meet
your stated targets?
Answer. The SNS currently holds approximately 60 million deployable
isolation gowns.
While SNS has made progress in building its inventory of gowns,
holding more than 12 times the amount held at the beginning of the
COVID-19 response, the progress has been exclusively to the inventory
of isolation gowns rather than surgical gowns. SNS currently holds
fewer than 1000 surgical gowns. SNS previously signaled its intention
to procure domestically manufactured surgical gowns to help close the
gap between current holdings and the COVID-19 target of 265 million
gowns.
______
Questions Submitted by Senator John Kennedy
Question. Secretary Becerra committed to ``robust enforcement''
during his confirmation hearing before the Senate HELP Committee (2/23/
21) to become the Secretary of the Health and Human Services
Department. Despite this commitment and widespread non- compliance, HHS
has failed to meaningfully enforce the hospital price transparency
rule.
A recent national survey found an overwhelming bipartisan majority,
87 percent of Americans, support the requirement for hospitals to post
prices, and nearly 79 percent want critical measures like transparency
in coverage to be implemented immediately without further delay.
A comprehensive study published February 2022 by Patient Rights
Advocate, reviewed 1,000 hospitals nationwide and found only 14.3
percent of hospitals are compliant with the HHS rule that went into
effect over 1 year ago.
Mr. Secretary, first can you tell the Committee how many hospitals,
as of today's hearing, have received warning letters and/or corrective
action plans for non-compliance?
Of the letters that went out to non-compliant hospitals, can you
please tell me how many responded?
Mr. Secretary, can you also tell me how many hospitals, who again
have had over 15 months to comply, have been issued a civil monetary
penalty?
When do you expect to issue your first civil monetary penalty for
non- compliance?
Can you commit to this committee, Congress, and the American people
that your Department will immediately post both compliant and non-
compliant hospitals on your website and begin issuing fines to non-
compliant hospitals?
Answer. CMS is committed to ensuring consumers have the information
they need to make fully informed decisions regarding their healthcare.
Hospital price transparency helps Americans know what a hospital
charges for the items and services they furnish.
The hospital price transparency final rule was published in
November 2019 and became effective January 1, 2021. The final rule
implements section 2718(e) of the Public Health Service Act (as added
by the Affordable Care Act) and requires each hospital, for each year,
to establish, update, and make public a list of the hospital's standard
charges for items and services provided by the hospital. The final rule
superseded guidance issued by CMS in 2015 and 2019. The rule requires
hospitals to make public five types of 'standard charges:' gross
(chargemaster) charges, discounted cash prices, payer-specific
negotiated charges, and the minimum and maximum de-identified
negotiated charges.
The final rule also specified methods by which CMS may monitor
hospitals' compliance with the requirements, including evaluating
complaints made to CMS, reviewing analyses sent by third parties
regarding hospital noncompliance, and auditing hospitals' websites.
Should CMS conclude a hospital is noncompliant with one or more of the
requirements to make public standard charges, CMS may take any of the
following actions, which generally, but not necessarily, will occur in
the following order:
(a) Provide a written warning notice to the hospital of the
specific violation(s).
(b) Request a corrective action plan from the hospital if its
noncompliance constitutes a material violation of one or more
requirements.
(c) Impose a civil monetary penalty not in excess of $300 per day
on the hospital and publicize the penalty on a CMS website if the
hospital fails to respond to CMS's request to submit a corrective
action plan or comply with the requirements of a corrective action
plan.
We expect hospitals to comply with these requirements and are
enforcing these rules to make sure Americans have information regarding
what the hospital will charge for their healthcare in advance. Prior to
the effective date, CMS developed a dedicated hospital price
transparency website found here: https://www.cms.gov/hospital-price-
transparency. This website includes resources to help hospitals comply
with the rule in addition to a method for consumers to contact CMS and
submit specific complaints related to hospital noncompliance.
In January 2021, we began proactive audits of hospital websites as
well as review of complaints submitted to CMS via the hospital price
transparency website. In April 2021, we issued the first set of warning
letters to noncompliant hospitals. These letters list specific areas of
deficiencies identified through CMS compliance review and request
hospital action to remedy the deficiencies. We intend to continue to
send warning letters on a rolling basis as we identify noncompliant
hospitals through our proactive audits and review of complaints.
Hospitals that fail to submit a corrective action plan or comply with
the requirements of a corrective action plan will be subject to a civil
monetary penalty. In the event CMS issues a civil monetary penalty
(CMP), CMS will identify the hospital and display the hospital's name
on a CMS website.
In November 2021, in the Hospital Outpatient Prospective Payment
System and Ambulatory Surgical Center Payment System Final Rule (CMS-
1753FC), CMS increased the civil monetary penalties that will apply to
noncompliant hospitals. The final rule set a minimum CMP of $300/day
for smaller hospitals with a bed count of 30 or fewer, and a penalty of
$10/bed/day for hospitals with a bed count greater than 30, not to
exceed a maximum daily dollar amount of $5,500. Under this approach,
for a full calendar year of noncompliance, the minimum total penalty
amount would be $109,500 per hospital, and the maximum total penalty
amount would be $2,007,500 per hospital. This approach to scaling the
CMP amount retains the original penalty amount for small hospitals,
increases the penalty amount for larger hospitals, and affirms the
Administration's commitment to enforcement and public access to pricing
information. The revised CMP policy took effect January 1, 2022.
Question. I understand that implementing a monumental law, such as
the No Surprises Act, takes time. To that extent, I am grateful that
the Federal Independent Dispute Resolution (IDR) portal was officially
opened in April. However, I am concerned as I have heard from providers
who have thousands of claims ineligible for the IDR process. Once the
Federal Portal was opened, providers were given 15 business days to
submit all claims to IDR where the 30-business day, post Open
Negotiation limit had expired. However, this extension does not apply
to claims where no Open Negotiation was initiated. This is worrisome as
I have heard from providers who did not submit claims for Open
Negotiation, as the portal was not open to file for IDR within the
required 4 days.
Would the Department of Health and Human Services (HHS) be willing
to open a 30-day window for reconsideration of all claims between
January 1, 2022 and April 14, 2022, allowing providers to initiate Open
Negotiations now that the Federal IDR portal has been established?
Answer. The Federal Independent Dispute Resolution (IDR) system
went live on April 15, 2022, and CMS has posted operational guidance
for providers and plans on the CMS No Surprises Act website. As
described in regulations and operational guidance, a 30-day open
negotiation period may begin after a provider or facility receives a
payment or denial notice from a health plan or issuer for applicable
out-of-network services. At the end of the 30-day open negotiation
period, if the health plan or issuer and provider or facility haven't
agreed on a payment amount, either party can submit the item(s) or
service(s) for review in the IDR process. If the disputing parties
experience extenuating circumstances during the IDR process that
prohibit them from complying with deadlines to submit information, they
may email the Departments at: [email protected] and
include the IDR dispute reference number, if known, to receive a
Request for Extension Due to Extenuating Circumstances form and
instructions for next steps. Consumers, providers, facilities, plans,
issuers, and FEHB carriers with questions about the No Surprises Act
can call the No Surprises Help Desk at 1-800-985-3059.
Question. According to the No Surprises Act Interim Final Rules,
insurers must provide an email and physical address to submit Open
Negotiations. However, I have heard from many providers that insurers
are inhibiting the flow of claims information by creating unnecessary
steps for providers who wish to exchange information on claims and
submit open negotiations, such as by withholding the required contact
information, withholding information on payment remittances, or by
requiring providers to register with various websites.
Will there be proper oversight to ensure these obstructive
practices are not occurring, and that proper transparency, as required
by law, is taking effect? What will the Administration to do prohibit
these burdensome hurdles impacting Open Negotiations?
Answer. HHS--together with our colleagues at the Department of
Labor, Department of the Treasury, and Office of Personnel Management--
has been working to implement the No Surprises Act (NSA) and ensure
that consumers receive the benefits of the protections included in the
law by Congress. We have released regulations and guidance for
providers, group health plans, health insurance issuers, and FEHB
carriers that explain the requirements related to the processing of
claims and the open negotiation process. We will continue to work to
provide additional training and technical assistance to help
stakeholders understand their obligations and comply with key
requirements of the NSA.
We are committed to ensuring compliance with the requirements of
the NSA and its implementing regulations. If you are hearing from
providers or plans about issues regarding compliance with the
requirements of the NSA, they should submit a complaint to the No
Surprises Help Desk at https://www.cms.gov/nosurprises/consumers/
complaints-about-medical-billing or by calling 1-800-985-3059.
Question. It was clear that the No Surprises Act was intended to
force providers and insurers to move in-network, avoiding the IDR
process altogether, creating a smoother process for all parties
involved. I am concerned, because in reality, everything I was afraid
of happening, is. I have heard from various providers that insurers are
using the No Surprises Act as leverage to cut in-network provider
contracts in half during negotiations. Others who have established the
necessary amount of contracts to establish a ``Median In-Network'' rate
are sending providers notices stating their networks are ``closed'' to
additional providers.
How is HHS addressing the issue of narrowing of networks and these
predatory practices?
Answer. Under CMS's Notice of Benefit and Payment Parameters for
2023 Final Rule, CMS finalized regulatory changes in the individual and
small group health insurance markets and establishes parameters and
requirements issuers need to design plans and set rates for the 2023
plan year. The rule also includes regulatory standards to help states,
the Marketplaces, and health insurance companies in the individual and
small group markets better serve consumers.
Under the final rule, CMS finalized changes to ensure that patients
have access to the right provider, at the right time, in an accessible
location. The rule requires qualified health plans (QHPs) on the
federally-facilitated Marketplaces (FFMs) to ensure that certain
classes of providers are available within required time and distance
parameters. For example, a QHP on the FFMs will be required to ensure
that its provider network includes a primary care provider within ten
minutes and five miles for enrollees in a large metro county. The rule
also sets a standard, starting in the 2024 plan year, requiring QHPs on
the FFMs to ensure that providers meet minimum appointment wait time
standards. For example, QHPs will be required to ensure that routine
primary care appointments are available within 15 business days of an
enrollee's request. Additionally, HHS will review additional
specialties for time (i.e., the time it takes the enrollee to get an
appointment) and distance (i.e., the distance between the provider and
enrollee)--including emergency medicine, outpatient clinical behavioral
health, pediatric primary care, and urgent care. OB/GYN parameters will
also be aligned with the parameters for primary care.
Additionally, Section 109 of Title I of Division BB of the
Consolidated Appropriations Act, 2021, requires HHS, in consultation
with the Federal Trade Commission and the Attorney General, to conduct
a study of the effects of the No Surprises Act on market concentration,
healthcare costs, and access. The first report is due no later than
January 1, 2023, and four additional reports shall study the effects of
the Act in the four subsequent years.
Question. I understand that medical procedures account for 96
percent of all human exposure to man- made radiation. This can result
in severe burns, cataracts, cognitive dysfunction, immunosuppression,
and even cancer--in patients and clinicians. While the CDC embraces the
guiding principle for radiation safety of ``as low as reasonably
achievable,'' or ``ALARA'', it is not aligned with current medical
procedures; increased use of high- radiation procedures like
fluoroscopy to place stents; extensive clinical data on the dangers of
radiation exposure and need for utilizing better precautions; and the
latest shielding technologies that can prevent this excessive,
avoidable radiation exposure.
How can we address this with appropriate guidance communicated
effectively to providers to prevent harm to them and their patients,
especially regarding simple changes like appropriate radiation
shielding?
Answer. Keeping in mind the diagnostic and potentially life-saving
value that these procedures provide to the public, the principles of
justification and optimization are essential to the practice of
radiation medicine. Are the diagnostic procedures indicated or
warranted (justification), and if so, are the procedures of high
quality to gain the needed diagnostic information with minimal dose
(optimization)? CDC sponsored the National Council on Radiation
Protection and Measurements (NCRP) to conduct the most recent estimate
of radiation doses to the U.S. population. This NCRP study provided an
update to the earlier estimate in 2009 that indicated the sharp
increase in average dose to the U.S. population due to the evolving
technology and use of these diagnostic tools.
______
Questions Submitted by Senator Hyde-Smith
Question. Local pharmacies and pharmacists have long been a trusted
and vital part of our local healthcare community. 9 in 10 Americans
live within 5 miles of a pharmacy, and many of those Americans have
come to rely on their pharmacy during the pandemic to provide vital
access to COVID-related services, including testing, vaccinations, and
treatments. Pharmacists were central to combating COVID-19, providing
more than 245 million vaccine doses and millions of tests across
20,000+ pharmacies nationwide. However, CMS treats pharmacists
differently than other healthcare professionals when it comes to
providing these services, and, ultimately, CMS does not have the
necessary payment structure to appropriately reimburse pharmacists for
these services.
Secretary Becerra, can you please elaborate on the efforts CMS has
taken to expand pharmacist provider status/reimbursement during the
COVID-19 PHE, and clarify which flexibilities granted to pharmacists
can and will be extended beyond the PHE? Specifically, how will
pharmacists receive reimbursement for COVID-19 tests and vaccine
administration after the PHE?
Answer. Pharmacists are essential parts of our healthcare system
and are playing an important role in the response to the COVID-19
public health emergency. Pharmacists may perform certain tests if they
are enrolled in Medicare as a laboratory, in accordance with a
pharmacist's scope of practice and state law. In addition, pharmacists
can enroll as mass immunizers and bill Medicare for administering Part
B vaccines.
We have explicitly clarified that pharmacists fall within the
regulatory definition of auxiliary personnel under our regulations. As
such, pharmacists may provide services incident to the professional
services and under the appropriate level of supervision of the billing
physician or practitioner, if payment for the services is not made
under the Medicare Part D benefit. This includes providing the services
incident to the services of the billing physician or practitioner and
in accordance with the pharmacist's state scope of practice and
applicable state law.
Question. 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
$3.5 million, despite the tremendous cost of CKD to society, Medicare,
and Medicaid. We must increase awareness and early detection of kidney
disease via a national kidney disease awareness public health
initiative, which the CKD Initiative at CDC is poised to do with proper
funding and community partnership.
Please comment on efforts to expand the Chronic Kidney Disease
Initiative to meet this awareness and early detection need.
Answer. The Chronic Kidney Disease (CKD) Initiative currently
conducts several activities to promote kidney health, including
collaborating with partners to support and enhance the CKD Surveillance
System. This system tracks kidney disease and its risk factors over
time and monitors progress in prevention, detection, and management.
The CKD initiative works to:
--Increase public awareness of CKD, its risk factors, and
complications through scientific publications, provider
resources, featured articles, and other educational resources.
--Promote early diagnosis and treatment of CKD by
--Encouraging providers to use the CKD e-phenotype to detect CKD in
people early on, help manage CKD, and help reduce CKD-
related complications such as heart disease and kidney
failure.
--Publishing on the state-level awareness of CKD in the U.S.
--Sharing information for the public on prevention and risk
management, and how to take care of your kidneys.
--Conduct surveillance, epidemiology, health outcomes, and economic
studies in partnership with other offices at CDC, other
government agencies, universities, and national organizations.
CDC is committed to the CKD Initiative, and its important work has
been highlighted in HHS' Advancing American Kidney Health Initiative.
In the fiscal year 2022 Omnibus, the CKD Initiative received an
increase of $1 million dollars from fiscal year 2021 funding (total of
$3.5 million). While continuing the current work of the CKD Initiative,
CDC is using the funding increase to:
--Study the effects of youth-onset type 2 diabetes on kidney
structure, function, and complications to identify novel and
specific targets for CKD prevention and treatment.
--Update the CKD cost effectiveness studies to include new data,
treatments, and numerous advances in our understanding of CKD
and its causes, progression, and treatment.
--Expand the analytical capacity of the CKD Surveillance System,
including analysis of large datasets and incorporating new
indicators of the social determinants of health and CKD
morbidity at the national, state, and county levels.
--Examine trends in incidence of end stage kidney disease, diabetes
complications, and impact on high-risk populations.
Question. There have been recent positive changes to clinical
practice in the diagnosis of kidney disease, namely the adoption of new
equations for estimating GFR that do not include race as a modifier.
What else is NIDDK doing to elevate kidney-specific research and
interventions to eliminate racial and ethnic disparities in kidney
care? Specifically, can you comment on investments in research
initiatives that bridge existing deficits in CKD management and
treatments to reduce incidence and progression, increase the number of
CKD clinical trials related to kidney disease (including efforts to
enhance participation of under- represented populations), identify
strategies to improve the delivery of evidenced-base care in under-
represented populations, and address issues related to kidney patients'
quality of life?
Answer. Addressing disparities in kidney disease outcomes is a
major research priority for the National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK). Recognizing that new approaches
are needed, the Institute held a workshop in February 2022 aimed at
helping design interventions to address structural racism in kidney
health disparities. An important outcome of this effort is a
forthcoming initiative, recently approved by the NIDDK's Advisory
Council, inviting clinical trials to develop and implement these and
other interventions in hopes of providing new, evidence-based solutions
to overcome disparities in chronic kidney disease and end stage renal
disease (also known as ESRD or kidney failure) care and outcomes.
The NIDDK is also determined to improve care and reduce disparities
in management of advanced kidney disease. For example, ESRD
disproportionately affects African Americans and can severely affect
quality of life, particularly for the roughly half of ESRD patients who
experience severe pain. The Hemodialysis Pain Reduction Effort (HOPE)
clinical trial is exploring non-opioid methods of pain management and
improving quality of life, with a focus on heavily affected
communities. The trial is engaging participants as partners in the
research process and study management to strengthen the science--
efforts that have also helped accelerate recruitment of new
participants.
A variation in the APOL1 gene that is more common in people of
African descent than in other populations is one factor accounting for
kidney disease disparities among African Americans. However, it is not
yet well understood how APOL1 variation might affect outcomes for
kidney donors or recipients. The APOL1 Long-term Kidney Transplantation
Outcomes Consortium is currently addressing these vital questions,
while employing a ground-breaking patient-engagement effort that served
as a model for HOPE and other studies. Another factor that worsens
disparities in outcomes for people with ESRD is the relative lack of
access to transplanted kidneys for communities of color. The NIDDK and
the Patient Centered Outcomes Research Institute are therefore working
together to fund the System Interventions to Achieve Early and
Equitable Transplants (STEPS) Study, an intervention designed to
improve access to transplantation for African Americans through
healthcare system change.
Question. Studies indicate that we could have over one million
people in kidney failure and need a transplant by 2030. Yet, each year,
thousands of recovered kidneys go un-transplanted, while every day, 12
people die waiting for a kidney transplant. Recently there has been
additional scrutiny into our organ procurement and transplantation
system, yet no major policy proposals have been announced to improve
this appalling failure of care. Organ Procurement Organizations are the
sole stakeholders in the transplant ecosystem responsible for
recovering and transporting deceased organs without legitimate
oversight and accountability to ensure quality assurance and
performance improvement. Transplant centers desperately need financial
incentives to accept less than perfect kidneys and care for complex
transplant patients. People of color and underserved communities face
numerous hurdles in being referred for a transplant evaluation.
What is HHS planning to do to reduce organ discards, improve
transplantation, and minimize racial and ethnic disparities in
transplantation access?
Answer. Organ procurement organizations (OPOs) are vital partners
in the procurement, distribution, and transplantation of human organs
in a safe and equitable manner for all potential transplant recipients.
The role of OPOs is critical to ensuring that the maximum possible
number of transplantable human organs is available to individuals with
organ failure who are on a waiting list for an organ transplant. HHS is
dedicated to improving health equity and access in the organ
procurement and transplantation system, including by holding OPOs
accountable for their performance.
In December 2020, CMS published ``Medicare and Medicaid Programs;
Organ Procurement Organizations Conditions for Coverage: Revisions to
the Outcome Measure Requirements for Organ Procurement Organizations''.
This rule finalized new outcome measures OPOs are required to meet for
re-certification and was published with the intention of increasing
donation and organ transplantation rates by replacing the previous
outcome measures with new transparent, reliable, and objective outcome
measures that are used to make better certification decisions and
incentivize better performance. The revised measure will encourage OPOs
to pursue all potential donors, even those who are only able to donate
one organ. CMS estimates that if every OPO were to meet or exceed this
measure, we could have approximately 5,600 more organs per year to
transplant.
HRSA is committed to an equitable and timely organ donation and
transplant system. This spring, HRSA issued a Request for Information
(RFI) to solicit feedback about opportunities to strengthen the Organ
Procurement and Transplantation Network (OPTN). In particular, the RFI
sought feedback on the ways to address many of the National Academies
of Science, Engineering, and Medicine findings and recommendations in
its report titled Realizing the Promise of Equity in the Organ
Transplantation System. HRSA released the RFI to better support HRSA's
efforts to increase accountability in OPTN operations, modernize
performance of the OPTN IT system and related tools, and improve
engagement with donors and patients. It specifically focuses on
opportunities to strengthen equity, access, and transparency. HRSA is
appreciative of the response to the RFI and is actively reviewing this
important feedback to inform the development of the next contracting
cycle. We look forward to continuing to engage with Congress as we
develop the next contracting cycle and continue to identify strategies
for modernization and accountability across the organ procurement and
transplantation system. In addition, HRSA is collaboratively working
with its CMS colleagues on an End Stage Renal Disease Treatment
Learning Collaborative (ETCLC) project designed to capture and share
best practices and processes to increase transplants and reduce
discards. The ETCLC focuses on kidney transplants, which make up
approximately 85 percent of the total waiting list. Improvements in
this area will have a broad impact on the system. HRSA is committed to
the critical work of continuously improving the organ donation and
transplantation system, and looks forward to continuing to work with
you on this issue.
______
Questions Submitted by Senator Patrick Leahy
Question. Due to a long-standing Federal policy known as the
`institutes of mental disease' (IMD) exclusion, states are prohibited
from claiming Federal Medicaid funds for in-patient mental health
services delivered to eligible individuals residing in hospitals or
institutions of more than 16 beds. While the exclusion was originally
intended to ensure that maintained primary financial responsibility for
inpatient psychiatric care and reduce the Federal cost share, it has no
clinical rationale and inhibits access to critical services for
Medicaid beneficiaries. This includes individuals suffering from
substance use disorders, which has hit an all-time high during the
COVID-19 pandemic. Many states such as Vermont are facing a critical
shortage to appropriate and timely mental healthcare that results from
a lack of funding for in-patient psychiatric beds.
What would be the fiscal cost over 10 years to repealing the IMD
exclusion?
How can Congress work with the agency to overcome the barriers
caused by the IMD exclusion and increase access to much needed in-
patient mental health treatment?
Concurrently, how will the President's budget be used to
incentivize and help states develop and provide community-based
services for individuals suffering from mental health disorders?
Answer. The Biden-Harris Administration is committed to expanding
access to affordable care, including inpatient psychiatric and
substance use disorder care when appropriate. While the Medicaid
statute prohibits states from receiving Federal financial participation
for services delivered to most individuals residing in an IMD, CMS has
worked within the confines of the law to provide states with
flexibility to increase access to these services. For example, CMS has
approved Medicaid section 1115 demonstrations that allow state Medicaid
programs to pay for services provided to adults with serious mental
illness/serious emotional disturbance or substance use disorder who are
short-term residents in an institution for mental disease (IMD).
Similarly, managed care organizations (MCOs) are permitted to reimburse
up to 15 days per month of treatment in IMDs as an in-lieu of service--
that is, a service that is not included under the state plan, but is a
clinically appropriate, cost-effective substitution for a similar,
covered service.
When appropriate, the Biden-Harris Administration also supports
strengthening home and community-based services (HCBS) as an
alternative to institutionalized care, in order to ensure that people
have access to safe options that work for them. People are happier and
healthier when they live in their community, and living in one's own
home and community usually costs less than care in an institution. The
department is working hand-in-hand with states to ensure they have the
time and support they need to strengthen their home care systems. HHS
recognizes the importance of HCBS which allow millions of Medicaid
beneficiaries to receive services in their own home or community rather
than institutions or other isolated settings. HHS looks forward to
working with Congress to improve this access.
Question. The COVID-19 pandemic has exacerbated a youth mental
health crisis in our country. A recent NIH-funded study revealed that
since the start of the pandemic, there has been an increase in the
number of suicides among youth 10-to-19 years of age. In the past year,
nearly 200 Vermont children have sought care for mental health related
issues at emergency rooms. Many of these children had to wait an
average of over 24 hours before they were seen for care. Rural states
like Vermont also face significant barriers to meeting the demand for
mental healthcare, the most prevalent being the shortage of behavioral
healthcare clinicians. I strongly support proposed investments in
school-based mental healthcare, early childhood intervention, community
mental health centers, and the 988 suicide prevention and crisis
support line to start to address these issues.
How will the agency use the proposed investments for youth mental
health to ensure that rural areas can adequately train, recruit and
retain behavioral healthcare providers that are pediatric specialists?
Answer. SAMHSA oversees multiple grant programs that support
training pediatric behavioral healthcare providers.
SAMHSA's Infant and Early Childhood Mental Health grant program
helps to address the national shortage of mental health professionals
with infant and early childhood expertise by training early childhood
providers and clinicians to identify and treat behavioral health
disorders of early childhood. In fiscal year 2021, grantees trained
4,003 clinicians and early childhood providers on evidence-based mental
health treatments for infants and young children. The Mental Health
Awareness Training grant program trains individuals, including primary
care and specialty healthcare providers, how to respond to individuals
with mental disorders appropriately and safely. The Certified Community
Behavioral Health Clinic Improvement and Advancement grant program
includes a staff training requirement as part of the overarching goal
of enhancing and improving community behavioral health systems.
SAMHSA also supports technical assistance centers that provide,
among other things, training to pediatric healthcare providers. These
centers include the Suicide Prevention Resource Center, National Child
Traumatic Stress Network, and Mental Health Technology Transfer Center
Network.
To strengthen the mental health and substance use disorder
workforce, the fiscal year 2023 budget provides an investment of $397
million for HRSA's Behavioral Health Workforce Development Programs,
which is $235 million above fiscal year 2022 enacted level. This
funding will increase training of new behavioral health providers,
including a track for health support workers such as peer support
specialists and community health workers and place an emphasis on team-
based care. In order to promote inclusive and equitable behavioral
healthcare for youth, this investment will support a special focus on
the knowledge and understanding of children, adolescents, and youth at
risk for a mental health disorder, Serious Emotional Disturbance, or
substance use disorder. The Behavioral Health Workforce Development
Programs includes $225.8 for Behavioral Health Workforce Education and
Training (BHWET) Programs. In fiscal year 2023, the BHWET Programs seek
to establish and expand field placements, internships, and experiential
sites for behavioral health professionals and paraprofessionals to
train, especially among children- and youth-focused community-based
partners who are able to conduct trainings in school-based settings. A
special focus is placed on the knowledge and understanding of children,
adolescents, and transitional-aged youth at risk for a mental health
disorder, Serious Emotional Disturbance (SED), and/or substance use
disorder.
The Budget also includes increases in Primary Care Training and
Enhancement and Nurse Education, Practice and Retention to expand
behavioral health services into primary care.
In fiscal year 2022, HRSA received $5 million for a pediatric
specialty loan repayment program under which participants will be
employed full-time for a specified period, of not less than 2 years, in
providing pediatric medical subspecialty, pediatric surgical specialty,
or child and adolescent mental and behavioral healthcare, including
substance use disorder prevention and treatment services. Program
participants will be required to work in, or for a provider serving, a
health professional shortage area or medically underserved area, or to
serve a medically underserved population.
The fiscal year 2023 President's Budget proposes $10 million for
the Pediatric Mental Health Care Access (PMHCA) program, which has
played an important role in helping to increase access to specialized
mental health providers and build provider capacity for children in
rural areas. The PMHCA program promotes behavioral health integration
in pediatric primary care through new or expanded statewide or regional
pediatric mental healthcare telehealth programs. These networks of
specialized pediatric mental healthcare teams provide tele-
consultation, training, technical assistance, and care coordination to
assist pediatric primary care providers.
Through the PMHCA Program, pediatric primary care providers are
able to diagnose, treat and refer children to the care they need for
behavioral health concerns. Telehealth technologies promote long-
distance clinical healthcare, clinical consultation, and patient and
provider education, helping address challenges in accessing behavioral
health clinicians who treat behavioral concerns in children and
adolescents.
The number of primary care providers enrolled in the PMHCA Program
increased from 1,963 in fiscal year 2019 to 4,511 in fiscal year 2020.
Authorization for the PMHCA program expires at the conclusion of fiscal
year 2022.
In addition, the fiscal year 2023 President's Budget includes $57.3
million, a $3 million increase over fiscal year 2022 enacted, for
HRSA's Autism and other Developmental Disorders program. Among other
programs, this investment supports the Developmental-Behavioral
Pediatrics Training Program (DBP) that trains Fellows in developmental
behavioral pediatrics to address the broad range of behavioral,
psychosocial, and developmental concerns that pediatric primary care
providers see. The program also supports practitioners' ability to
provide proven interventions to children's behavioral and developmental
concerns, including for individuals with autism spectrum disorder and
other developmental disabilities. In fiscal year 2020, the DBP Training
Program trained over 1,400 DBP Fellows, medical students and pediatric
residents. DBP graduate survey results show that 5 years following
completion of the program, 100 percent of DBP Fellows demonstrated
leadership, worked in an interdisciplinary manner, and worked with
maternal and child health populations, including those considered to be
underserved. The proposed fiscal year 2023 increase will help support
the DBP program, as well as the Leadership Education in
Neurodevelopmental and Other Related Disabilities (LEND) Training
program to address unmet needs and disparities in evaluation,
diagnosis, and treatment. For DBP, funding will allow expansion of the
DBP program including increased fellowship opportunities for existing
awardees.
Finally, the fiscal year 2023 President's Budget supports the Child
and Adolescent Health Promotion Services Program, referred to as the
Bright Futures Program. This program supports quality health promotion
and preventive services for all children, adolescents, and young adults
through evidence-driven, strengths-based clinical guidance. This
includes the Periodicity Schedule of the Bright Futures Recommendations
for Pediatric Preventive Health Care (``Periodicity Schedule''), which
includes preventive services that group health plans and health
insurance issuers must cover without cost sharing. The Periodicity
Schedule recommends several mental and behavioral health screenings be
conducted during well visits. This program serves providers across the
country, including those in Health Provider Shortage Areas (HPSA),
Medically Underserved Areas (MUA), and providers who serve patients
from historically marginalized backgrounds.
Question. Vermont, like many other states, is currently facing a
severe nursing shortage. The State has forecasted 6,244 vaccines within
the nursing professions within the next 2 years, largely caused by an
aging workforce and mental burnout that has been accelerated by the
COVID-19 pandemic. There is also an inadequate number of nursing
educators to train the next generation of nurses.
How can HHS help states to build and bolster resilient nursing
pipelines and nurse training programs?
Answer. CDC makes essential workforce and training resources
accessible across the globe through the Department of Health and Human
Services, CDC, and state and local health departments. CDC's
fellowships are a pathway for training and recruiting the next
generation of public health leaders, including nurses.
With short-term ARP funds, CDC is working with the Corporation for
National and Community Service (CNCS) to place members onsite at public
health departments to help meet current staffing needs for the COVID
response. This is one component of a longer-term program to support
ongoing public health staffing needs and future surge staffing needs
for emergencies. While meeting immediate staffing needs, the Public
Health AmeriCorps, established jointly between CNCS and CDC will also
include a goal of creating a pathway of entry level, future public
health professionals, including nurses. The joint venture between
AmeriCorps and the CDC received 122 applications representing community
organizations from 41 of 50 states. Funding decisions and notices of
awards from AmeriCorps were released in April 2022. For more
information: https://americorps.gov/newsroom/press-release/americorps-
cdc-award-more-60-million-public-health-americorps-programs-part.
CDC is providing $3 billion in grants to state, territorial, and
local jurisdictions. CDC plans has posted the notice of funding
opportunity, and awards will be made in 2023. Funding will support
hiring, retention and training of public health workers, particularly
from the communities they are intended to serve, and will permit the
funding of a broad range of public health workers, including nurses and
public health nurses and other community health professionals.
The nursing pipeline is supported and enhanced through HRSA
programs:
--The Nurse Corps Scholarship and Loan Repayment Programs assist in
the recruitment and retention of nurses while reducing the
financial barrier to nursing for all levels of professional
nursing students and increase the pipeline of nurses by
supporting nurses and nursing students committed to working in
communities with high need. Additionally, the Nurse Corps
program supports nurse faculty who will train the next
generation of nurses. In fiscal year 2023, HRSA anticipates
funding scholarship and loan repayment awards.
--Another challenge for advancing and growing the nursing field is
recruitment and training of nurse faculty. To address this
issue, in fiscal year 2023, HRSA will also support the Nurse
Faculty Loan Program (NFLP), which provides funding to
accredited schools of nursing to establish and operate a
student loan fund and provide loans to students enrolled in
advanced education nursing degree programs who are committed to
becoming nurse faculty. In exchange for completion of up to 4
years of post-graduation full-time nurse faculty employment in
an accredited school of nursing, the program authorizes
cancelation of up to 85 percent of the student loan.
--An additional area of focus in our nursing work is recruiting and
training nurses who are underrepresented in the nursing
profession. The Nursing Workforce Diversity (NWD) Program
supports nurse training for individuals from disadvantaged
backgrounds (including racial and ethnic minorities
underrepresented among registered nurses).
--The fiscal year 2023 Budget Request also would support the Advanced
Nurse Education Program at $105.6 million, $20 million above
the fiscal year 2022 enacted level. The Budget includes an
increase of $20 million for grants to grow and diversify the
maternal and perinatal health nursing workforce by increasing
and diversifying the number of Certified Nurse Midwives with a
focus on practitioners working in rural and underserved
communities.
--The Scholarships for Disadvantaged Students (SDS) Program dedicates
16 percent of its total budget to providing scholarships to
educate and train bachelor and graduate-level nurses and nurse
midwives from disadvantaged backgrounds to address nursing
shortages in rural and underserved communities. The SDS Program
currently funds 25 bachelor and graduate-level nursing schools
across the United States and its territories.
SUBCOMMITTEE RECESS
Senator Murray. The committee will next meet in Dirksen
138, Wednesday, May 17, at 10 a.m. for a hearing on the Biden
Administration's budget request for the National Institutes of
Health. The committee is adjourned.
[Whereupon, at 11:10 a.m., Wednesday, May 4, the
subcommittee was recessed, to reconvene at 10 a.m., Wednesday,
May 17.]