[Senate Hearing 117-135]
[From the U.S. Government Publishing Office]
S. Hrg. 117-135
THE PRESIDENT'S FISCAL YEAR 2023
HEALTH AND HUMAN SERVICES BUDGET
=======================================================================
HEARING
before the
COMMITTEE ON FINANCE
UNITED STATES SENATE
ONE HUNDRED SEVENTEENTH CONGRESS
SECOND SESSION
__________
APRIL 5, 2022
__________
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Finance
_______
U.S. GOVERNMENT PUBLISHING OFFICE
55-074-PDF WASHINGTON : 2024
COMMITTEE ON FINANCE
RON WYDEN, Oregon, Chairman
DEBBIE STABENOW, Michigan MIKE CRAPO, Idaho
MARIA CANTWELL, Washington CHUCK GRASSLEY, Iowa
ROBERT MENENDEZ, New Jersey JOHN CORNYN, Texas
THOMAS R. CARPER, Delaware JOHN THUNE, South Dakota
BENJAMIN L. CARDIN, Maryland RICHARD BURR, North Carolina
SHERROD BROWN, Ohio ROB PORTMAN, Ohio
MICHAEL F. BENNET, Colorado PATRICK J. TOOMEY, Pennsylvania
ROBERT P. CASEY, Jr., Pennsylvania TIM SCOTT, South Carolina
MARK R. WARNER, Virginia BILL CASSIDY, Louisiana
SHELDON WHITEHOUSE, Rhode Island JAMES LANKFORD, Oklahoma
MAGGIE HASSAN, New Hampshire STEVE DAINES, Montana
CATHERINE CORTEZ MASTO, Nevada TODD YOUNG, Indiana
ELIZABETH WARREN, Massachusetts BEN SASSE, Nebraska
JOHN BARRASSO, Wyoming
Joshua Sheinkman, Staff Director
Gregg Richard, Republican Staff Director
(II)
C O N T E N T S
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OPENING STATEMENTS
Page
Wyden, Hon. Ron, a U.S. Senator from Oregon, chairman, Committee
on Finance..................................................... 1
Crapo, Hon. Mike, a U.S. Senator from Idaho...................... 3
.................................................................
ADMINISTRATION WITNESS
Becerra, Hon. Xavier, Secretary, Department of Health and Human
Services, Washington, DC....................................... 5
ALPHABETICAL LISTING AND APPENDIX MATERIAL
Becerra, Hon. Xavier:
Testimony.................................................... 5
Prepared statement........................................... 49
Responses to questions from committee members................ 57
Crapo, Hon. Mike:
Opening statement............................................ 3
Prepared statement........................................... 118
Wyden, Hon. Ron:
Opening statement............................................ 1
Prepared statement with attachment........................... 119
Communication
Center for Fiscal Equity......................................... 125
(III)
THE PRESIDENT'S FISCAL YEAR 2023
HEALTH AND HUMAN SERVICES BUDGET
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TUESDAY, APRIL 5, 2022
U.S. Senate,
Committee on Finance,
Washington, DC.
The hearing was convened, pursuant to notice, at 10:08
a.m., via Webex, in Room SD-215, Dirksen Senate Office
Building, Hon. Ron Wyden (chairman of the committee) presiding.
Present: Senators Stabenow, Cantwell, Menendez, Carper,
Cardin, Brown, Bennet, Casey, Warner, Whitehouse, Hassan,
Cortez Masto, Warren, Crapo, Grassley, Cornyn, Thune, Portman,
Toomey, Cassidy, Lankford, Daines, Young, and Barrasso.
Also present: Democratic staff: Shawn Bishop, Chief Health
Advisor; Peter Fise, Health Counsel; Kristen Lunde, Health
Policy Advisor; and Joshua Sheinkman, Staff Director.
Republican staff: Erin Dempsey, Deputy Health Policy Director;
Kellie McConnell, Health Policy Director; Gregg Richard, Staff
Director; Conor Sheehey, Senior Health Policy Advisor; and
Jeffrey Wrase, Deputy Staff Director and Chief Economist.
OPENING STATEMENT OF HON. RON WYDEN, A U.S. SENATOR FROM
OREGON, CHAIRMAN, COMMITTEE ON FINANCE
The Chairman. The Finance Committee will come to order.
Today the committee meets with Secretary Becerra to discuss the
year ahead for the Department of Health and Human Services.
There is much to cover, and I will begin with telemedicine.
This committee began to open the door to telemedicine in
Medicare with the landmark CHRONIC Care Act authored with
Senator Hatch in 2017. Then in 2020, we shoehorned telehealth
services into the CARES Act. In implementing the law, Medicare
decided to cover telehealth audio-only on a temporary basis
during the pandemic. That has been met with wide-open arms from
people across the country, especially in rural communities.
In this year's appropriation bill, our colleague, Senator
Crapo, and I pushed together to extend the audio-only
flexibility beyond the public health emergency. There is, as
you will hear this morning, Mr. Secretary, bipartisan interest
in building on the telemedicine progress. We want to make it
permanent, and we want to make sure that we are not going to
turn the clock back on patients who have come to rely on these
critical services.
I think you can count on plenty of discussion of that
today.
Now, Senate Democrats and the administration are committed
to protecting bedrock health-care programs, strengthening the
Affordable Care Act, and upholding the Medicare guarantee.
Sadly, Republicans in the Senate have other ideas. Senator Rick
Scott, the campaign visionary for Senate Republicans, recently
proposed phasing out Medicare in 5 years. I am curious how
America's 60-year-olds are going to feel about that one. Next,
Senator Ron Johnson has doubled down on a long-time crusade of
repealing the Affordable Care Act altogether. Senator Johnson
says Republicans ought to be preparing their repeal bill now,
to have it ready to go when they take power.
If it looks like it did last time, it is going to gut
health care in America for tens of millions and shower tax
handouts to the wealthy. That is not what Oregonians and
Americans I am talking to have on their mind. The biggest
concern going today for millions of families in my State of
Oregon and across the country is the rising cost of living.
Bringing down health-care prices and protecting Americans from
getting clobbered with huge bills is one of the best ways for
Congress to take some of the pressure off the pocketbooks of
Americans.
A couple of areas I will highlight. For one, millions of
Americans are getting a better deal on their health insurance
this year because of the Rescue Plan passed in March of 2021.
Monthly premiums for Americans who get insurance on the
individual market fell by more than 22 percent this year,
adding up to hundreds of dollars or more over 12 months. People
across all income levels save money. Six million new consumers
got coverage. Go back some decades and Republicans would be
shouting from the mountain tops about the incredible success of
the private marketplace. Not so in 2022. These days,
Republicans have gone on record against the tax credits that
have made the success I just mentioned possible.
If Republicans have their way, millions of Americans are
going to get hit by higher health insurance premiums in 2023.
That cannot be allowed to happen, and Democrats will keep
pushing to make sure those savings continue.
The administration and Democrats in Congress are also
working in lockstep to bring down prescription drug prices. For
so many Americans, every trip to the pharmacy counter means
getting mugged by the drug companies. Instead of using the
bargaining power of more than 60 million American seniors to
get lower prices, Medicare's hands, under current law, are tied
behind its back.
Changing that by giving Medicare the authority to negotiate
a better deal for brand-name drugs is the single most important
reform on offer. Democrats also plan to cap copays for insulin
at $35 a prescription, and set an out-of-pocket cap for
seniors' prescriptions in Medicare Part D at $167 per month.
The plan would also create a tough new price-gouging
penalty for drug companies that increase prices over inflation.
This plan also will save money for patients on Medicare and in
the private market, and it is going to save taxpayers billions
of dollar each year.
So, getting a better deal on health insurance and
prescription drugs, these are the kinds of savings that, on our
side of the aisle, we are going to insist on--not because of
political reasons, but because millions and millions of
Americans of all political views desperately need that help
now. We have got to step up and deliver.
Finally, let me note the bipartisan work in the committee
that is going on with respect to mental health care. Senator
Crapo and I have talked about it often. This is one of the most
important initiatives this committee has pursued, given the
fact that there was a problem before the pandemic. That problem
might have been here [raising hand]. After the pandemic, it has
mushroomed [raising hand higher], and we hear it from kids, we
hear it from families, we hear it from seniors, we hear it in
rural communities. We hear about it every time we are home.
And adding Medicare coverage for seniors for sessions with
a therapist or a counselor, getting rid of caps on Medicare
coverage for care in a psychiatric hospital, smart proposals
that the Biden administration is making with respect to
Medicare and Medicaid, these are all important efforts, and we
are going to support them, along with waiving cost sharing for
up to three mental health visits a year in Medicare and private
insurance. And let me note that my seatmate here has been
leading the Congress in expanding Medicaid funding for
Certified Community Behavioral Health Clinics. And we are
making a special focus on that as part of our bipartisan
efforts in the committee.
These proposals we are talking about, the proposals that
are in the budget, the proposals that this committee is working
on, are going to be a lifeline to people who are struggling to
connect with mental health providers.
You are going to get some questions on this, for sure,
Secretary Becerra, because members on both sides of this
committee are laser-focused on mental health care. We look
forward to working with the administration on these issues in a
bipartisan way.
We want to thank you, Secretary Becerra, for being here.
There is lots to talk about.
[The prepared statement of Chairman Wyden appears in the
appendix.]
The Chairman. Senator Crapo?
OPENING STATEMENT OF HON. MIKE CRAPO,
A U.S. SENATOR FROM IDAHO
Senator Crapo. Thank you, Mr. Chairman, and thank you,
Secretary Becerra, for being here with us today.
Our Federal health-care programs face a range of pressing
challenges which demand serious solutions. Today's hearing
provides a crucial opportunity to highlight both shared
opportunities and priorities and concerns with respect to the
proposals put forward by the President.
As a part of the Cancer Moonshot initiative, the
administration has rightly acknowledged the value of
multicancer early detection tests which have the potential to
boost the cancer survival rate, while driving down costs.
Earlier in this Congress, I reintroduced bipartisan legislation
with Senator Bennet to ensure Medicare coverage for those
screening tools, and I look forward to working with you,
Secretary Becerra, to move this bill across the finish line.
The budget proposal's focus on mental health also offers
potential for common ground. Unfortunately, other aspects of
the budget request raise substantial questions. It is
imperative that we work now to keep Medicare strong not only
for current enrollees, but also for future generations. The
Medicare trustees have repeatedly cautioned that the program's
financial shortfalls will require legislative action, with the
hospital insurance trust fund projected to reach insolvency in
2026.
We have yet to receive this year's trustee's report, but
the President's budget includes no proposals to shore up the
trust fund's solvency. In fact, the document contains virtually
no sources of Medicare savings at all, instead opting for a
long list of coverage expansions, often with no cost estimates.
Proposing dozens of new spending policies with no sense of
their budgetary effect risks deepening the deficit and
exacerbating inflation. A similar pattern persists for the
budget request's Medicaid provisions, which would add billions
in new spending without any meaningful cost savings reforms.
Compounding these onerous impacts, the budget includes a
placeholder for a reckless tax and spending package, presumably
the nearly $5-trillion House-passed Build Back Better Act that
was defeated on a bipartisan basis last year and rejected
across this country. The government price controls, Obamacare
subsidy hikes, and other misguided policies included in that
bill would intensify the hardships that many Americans
currently face.
Under the package's price controls, we would inevitably see
fewer cutting-edge treatments and higher launch prices for new
drugs, and a drastic decline in innovative R&D, once again
handing the Chinese Communist Party a competitive edge. Long-
term Obamacare subsidy expansions, meanwhile, would double down
on skyrocketing Federal spending and force taxpayers to fund
coverage for Americans with six-figure salaries. These policies
would worsen the economic outlook for working families. By
continuing to push forward this problematic agenda, the
proposed budget has missed a key opportunity to address urgent
issues and needs.
As States and health-care providers across the country look
to the budget for this year ahead, uncertainty abounds. The
complex layers of flexibilities and coverage mandates tied to
the public health emergency necessitate clear and comprehensive
communication and accounting, particularly as stakeholders
attempt to map out the path to post-pandemic normalcy. Without
greater transparency both for Congress and the Nation, this
process could prove unpredictable and needlessly costly.
Coverage dynamics, for instance, will likely be volatile at the
end of the public health emergency, yet this budget provides no
plan for transitions in care.
Last year's $1.9-trillion partisan spending bill suffered
from poor planning and prioritization, with only around 1
percent of the package's funding directed to vaccines and
therapeutics. This year's budget request provided a chance to
chart a more thoughtful return to normalcy, continuity, and
fiscal responsibility. Disappointingly, the document does not
rise to that occasion.
Secretary Becerra, I look forward to engaging with you on
these and other issues in the months ahead, particularly as my
colleague, Senator Wyden, mentioned, on telehealth, which
continues to enjoy broad bipartisan support.
Thank you again for being here, and thank you, Mr.
Chairman.
[The prepared statement of Senator Crapo appears in the
appendix.]
The Chairman. Thank you, Senator Crapo. We are going to
you, Mr. Secretary, in just a minute. I just want to make one
quick comment about the trust fund, because this, I am sure, is
going to come up through the course of the morning.
We all understand that we are going to have to work on this
in a bipartisan way. So the question is, where are you going to
start? Are you going to start with cutting costs, or are you
going to start with cutting benefits? We have made it clear in
our work with respect to prescription drugs, we are all in on
measures to cut costs. That is where we are going to start. We
are going to work in a bipartisan way. We are not going to
start with cutting benefits. We are going to start with cutting
costs.
Please go ahead, Mr. Secretary, with your comments.
STATEMENT OF HON. XAVIER BECERRA, SECRETARY, DEPARTMENT OF
HEALTH AND HUMAN SERVICES, WASHINGTON, DC
Secretary Becerra. Chairman Wyden and Ranking Member Crapo,
and each of the members of the committee, I want to thank you
for this opportunity to discuss the President's Fiscal Year
2023 budget for the Department of Health and Human Services.
Today, if I could start, more than 255 million Americans
have received at least one dose of a COVID-19 vaccine. Two-
thirds of adults over age 65 have gotten their booster shots.
We have also closed the gaps in vaccine rates that we usually
see for communities often left behind.
It has paid dividends to surge resources, including tests
and treatments, to our hardest-hit and highest-risk
communities. Three hundred and twenty-five million free COVID-
19 at-home tests have been shipped; 270 million free N95 masks.
From the $186 billion appropriated by Congress for the
Provider Relief Fund, over 400,000 providers have received more
than 766,000 payments for COVID services. Again, that is over
400,000 doctors, hospitals, community health centers,
pharmacies, labs, nursing homes, and long-term care facilities,
all receiving this critical support. That is real money, real
relief, real results.
Now yesterday, I had a chance to meet with Medicare
beneficiaries who are now able to purchase their over-the-
counter COVID-19 tests with their red, white, and blue Medicare
card. Mr. Chairman, this marks the first time that Medicare has
covered an over-the-counter test at no cost to beneficiaries.
That is a game-changer.
Beyond COVID-19, today more Americans have insurance for
their health care than ever before. And that of course includes
a record-breaking 14.5 million Americans who secured health
insurance through the Affordable Care Act. That is a big deal,
as we know someone once said. Also today, the Biden
administration is issuing a rule that will fix the health
insurance so-called ``family glitch,'' which leaves out family
members from affordable coverage. Less noticed, 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 are coordinating nearly $300
million in Nationwide support for the launch of the 988
national suicide prevention lifeline this July.
HHS has also made key investments to close holes in our
public health system, 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.
The President's 2023 budget lets us build on that record of
investment in Americans' health. It proposes $127 billion in
discretionary budget authority and $1.7 trillion in mandatory
funding, including a historic investment to transform the
mental health infrastructure in our country, a priority I know
you share.
It also asks for $82 billion for the President's pandemic
preparedness proposal to get ready for whatever might come next
after COVID-19. Considering that COVID has cost this country
more than $4.5 trillion in direct support from the Federal
Government so far, this is a no-brainer to prepare for the next
pandemic. The funding we are requesting will be end-to-end for
research and development, approvals, deployment, and effective
response.
Budgets represent not just dollars and investments, but our
values and our priorities. This budget turns hardship into
hope, and inclusion into opportunity. And it is a commitment to
finish the fight against COVID-19 and build a healthier
America.
Mr. Chairman and members of the committee, I look forward
to working with you to make the President's 2023 budget a
reality, and to continue our efforts to give Americans real
relief, real results, and real peace of mind.
With that, let me yield back and answer any questions you
might have.
[The prepared statement of Secretary Becerra appears in the
appendix.]
The Chairman. Thank you, Mr. Secretary. And it is going to
be a little hectic even by Congress's standards this morning,
because we are going to be going back and forth on some
procedural votes with respect to our outstanding nominee to
serve on the Supreme Court.
Mr. Secretary, I am going to start with you on mental
health parity. And we had testimony a week ago from leading
experts in the field that private insurers, the big private
insurers, are making a mockery out of the parity law. You
remember the history. We all looked at that and said what
Senator Wellstone and Senator Domenici had achieved would
finally be justice for families. And this is something that
member after member on this committee knows personally, as the
Wyden family does, with respect to experiences with family
members.
One of the really shocking aspects of this is that the GAO,
not a partisan organization, basically said that the insurance
system is riddled with something they called ghost networks--
their words not mine: ghost networks. When you have a ghost
network run by one of these big insurance outfits, you cannot
get to providers. You have a bunch of directories that are out
of date, do not give you any information. And then the ultimate
insult is, their payments are so puny that the person
basically, and the family, is eating all the costs themselves.
It just makes a farce out of the parity law, which of course
said that mental health and physical health would be treated
fairly.
What is the administration's agenda to take on these big
private insurers? Because I think, Mr. Secretary--you and I
worked together when we were in the Congress--somebody is going
to have to make it clear that this is a priority, because they
are using every trick in the book to get out of honoring the
law.
At the Oregon Health Sciences Center, for example, they
had, during the pandemic, all these bills that did not get
paid. And I had visited with them, and they said, ``Well, the
insurer said we do not have any people, and nobody can process
the bill.'' So I met with the GAO, and the GAO opened an
investigation. And then, what a surprise. All of this money
started gushing into the Oregon Health Sciences Center. And we
all laughed a little bit, but you almost feel like crying
because, essentially, you walked away with the judgment that
these insurance companies would not pay unless they got
embarrassed by the local member of Congress in the newspapers.
So what is the administration's plan--I know you are very
interested in this topic--to really go after the big insurers,
the big companies that make huge sums in the mental health
field, and to really crack down on these abuses?
Secretary Becerra. Mr. Chairman, what you have just
articulated, I believe, would probably be expressed by the vast
majority of American families who feel this. And what the
President has essentially directed us to do is to figure out a
way where we can get some progress. So for example, we are
going to, in this budget, provide States with more money to
enforce those parity laws, so that they can actually go out
there and do that. We are going to try to support States that
are trying to move towards those parity laws in ways that are
meaningful so that you have true services that you can access
as a family member.
We are going to try to eliminate the 190-day lifetime limit
on psychiatric hospital services that are available to families
under Medicare, working with you to do that. We are going to
try to do what we can, like we did last year with the American
Rescue Plan, where we put in a $3-billion investment in
behavioral health services, half of it going to mental health
services, half of it going to substance use disorder services,
so we could prime the pump to get things moving.
But as you said, today we know, as a result of COVID
especially, families are really suffering mental stress.
The Chairman. And, Mr. Secretary, I am going to let my
colleagues ask their questions, because time is so short this
morning. I think all of those steps are very good and very
constructive, and I support all of them.
I just hope you will really hold some of these big private
insurers accountable, because the foot-dragging takes your
breath away. I saw in the press the other day, one of them
said, ``Well, we are just coming around to the law. We are just
getting adjusted to it.'' And you say to yourself: ``Are you
kidding me?'' This law has been on the books for 13 years--13
years of foot-dragging and excuse-mongering that is pretty much
the order of the day. So I very much look forward to working
with you on it. And let's really make an example. Make an
example with two or three of these companies, and we will be in
a position to get some real changes.
I have a couple of my colleagues voting. Senator Grassley,
you are next.
Senator Grassley. Thank you, Senator. And thank you, Mr.
Secretary, for being here.
The first thing is to thank you for allowing transitional
health insurance plans to be sold next year. Sixty-five
thousand Iowans will benefit from that. This is something I
have urged you to do. These are farmers and small business
people who have chosen to keep their health insurance that they
purchased between 2010 and 2013.
My first issue is about over-the-counter hearing aids.
Thank you for your commitment to implementing this legislation
by regulation. And the legislation that Senator Warren and I
got passed ensures that FDA finalizes the rules in a timely
way, and in a manner that Congress intended, not what special
interest groups want. And I do not know how those special
interest groups are interacting with anybody in the executive
branch, but I sure know how four major players weighed in
heavily for us not to pass this legislation in the first place.
The comment period ended January 18th. Can you give us any
date when these regulations might be out?
Secretary Becerra. Senator, those will be out very soon. I
cannot give you the precise date, but pretty soon, and you can
hold me to that. But can I just say ``thank you'' for giving us
the chance to do this, because without the effort that you all
undertook, we would still be trying to fight to give our family
members decent hearing aids.
Senator Grassley. It is obviously not your fault that it
took 5 years, but we passed the legislation, I believe in 2017,
or else early 2018.
Now the next question deals with--I don't know whether you
are aware of it or not, but it took about 8 months to receive
answers to our written questions from last June's budget
hearing. And I know as a member of Congress that you would be
frustrated with this. Could you commit to HHS being more
responsive to our written questions?
Secretary Becerra. Absolutely, Senator. As a former member
of this body on the House side, I know exactly what you are
going through. We received over 500 letters. We have had to do
more than 500 briefings in this past year. It takes a little
while, but I am committed to make sure we respond as quickly as
possible, and are as transparent as we can be.
Senator Grassley. According to the Medicare trustees, the
hospital insurance trust fund is expected to be depleted in
2026. Unlike the Obama administration's budget requests, the
Biden administration provided no major policies to improve the
solvency of the fund.
Am I understanding that correctly? Does President Biden
have a plan to address Medicare's solvency?
Secretary Becerra. Senator, we are prepared, as I think
Senator Wyden, the chairman, mentioned, to work with you on a
bipartisan basis. We know that there are solutions there. We
know there is bipartisan support for Medicare, and we agree
with Senator Wyden that it is important that we look at the
costs, not the benefits, of Medicare as we move to reform the
system to keep it going for a long time.
Senator Grassley. Lowering prescription drug prices is on
the mind of every member of Congress, and you and I have talked
about my work in that area, and doing it in a bipartisan way.
We are 16 months into a new administration, and both Houses are
controlled by the Democrats. We have not made any progress on
this issue. I continue to meet with Democrats and Republicans
to move a bipartisan prescription drug bill. Recent public
comments suggest that the administration may bypass Congress
and take executive action.
Questions in regard to executive action: is the
administration preparing any executive action on drug pricing,
and if so, could you give us some details?
Secretary Becerra. Senator, with one in three Americans
reporting that they are not taking their medication because it
is too costly, we need to do something. We certainly intend to
use whatever available authority we have to try to lower the
costs of prescription drugs, but we are also very intent in
working with you on a bipartisan basis to get something done.
This is one area where everyone agrees the costs of
prescription drugs are way too high, and we have to do
something. So we will look to use whatever executive or
available authority we have, but we hope that we can work with
you to get something done in a real meaningful way.
Senator Grassley. Just let me make a statement in my last
10 seconds. I hope the administration will engage in a
bipartisan way to pass bipartisan price reform legislation, and
I would suggest a good starting point would be the things that
Senator Wyden and I have worked on.
Thank you, very much.
Secretary Becerra. Thank you.
The Chairman. Thank you, Senator Grassley.
Senator Cardin?
Senator Cardin. Thank you very much, Mr. Chairman.
Mr. Secretary, it is good to be with you. I want to start
with an issue that I have raised before that I am pleased is
included in the President's budget. And that is, the
persistence of drug shortages here in America, which is kind of
shocking when you consider the amount of resources we spend for
prescription medicines in this country--far outpacing any other
country.
The recent study by the American Society of Health Systems
Pharmacists says there are over 200 prescription drugs that are
currently in shortage. And these medicines are often lifesaving
and a cornerstone of critical care in hospitals and other
settings.
The FDA's authority to address drug shortages by requiring
products to be labeled with the longest possible expiration
date is something that I initiated with a legislative proposal,
and I am glad to see it is in the President's budget. The
President's budget also includes $21.6 million for a resilient
supply chain and shortages program. I want to just give you a
moment to assure us that we can work in partnership and as
aggressively as we possibly can. There should be no drug
shortages in the United States of America. Many times the
shortages are simply an economic issue of the drug manufacturer
rather than the ability to have the drugs available in our
market.
So, thank you for the initiatives that are in the budget,
but I hope that this will have your personal attention.
Secretary Becerra. Absolutely, Senator, because, as you
said, this is not an issue of not knowing that there is a drug
out there, it is just not having sufficient supply. Part of it
is the supply chain. Part of it is the economics that drive
some of these manufacturers to not produce as much as we need.
Either way, we have no excuse to not have the supply of drugs
that all Americans need.
Senator Cardin. I appreciate that. But I hope that you will
focus on the way that we can make sure the supply chain is
there, with a carrot and stick approach, so that if necessary,
we take action against the pharmaceutical companies with the
power that we have to make sure that there is adequate supply
in this country.
Let me go to a related point, and that is, the President's
budget includes a $200-million increase for the National
Institute of Minority Health and Health Disparities. President
Biden has been very clear about his commitment to deal with
equal opportunity in America, including access to health care.
In the Affordable Care Act, we legislated the National
Institute of Minority Health and Health Disparities. It was our
initiative, and I am glad to see that there is a priority being
set by this administration in its budget. But it goes beyond
that. There are a lot of systemic challenges to equal access to
health care in America that go well beyond just dollars.
So, tell me your strategy to put a priority on the
President's commitment for fairness in American health care.
Secretary Becerra. Senator, the fingerprint of fairness and
inclusion are on everything we do now. Equity is critical. We
saw that as a result of COVID: how many people we have let fall
through the cracks. And so, one of the things that we did was,
rather than wait for people to come to us, especially people
who are not accustomed to having access to some of these
services, we went to them. And the result has been, when it
comes to vaccines, the disparity that we used to see between
White Americans who got vaccinated and people of color has
disappeared.
The disparity we saw in people applying for enrollment in
the Affordable Care Act is beginning to disappear. And what we
have done is essentially gone to people who are not accustomed
to having our government say to them, ``There is a great
service out here you could take advantage of.''
The other thing I will mention is on the Affordable Care
Act, for example navigators--those who help people understand
the process and what is best for them. We quadrupled the number
of navigators we put out there so people could make a good
decision. The result was that 14.5 million Americans today have
health insurance because of the Affordable Care Act.
Senator Cardin. And I would just point out that there are
multiple challenges to equity issues in getting access to
health care, some of which go beyond your specific
responsibility. And I just urge you to be a leader among the
Cabinet to address the equity issues.
I want to underscore the chairman's point on telehealth. It
works. We know it. People like it. It really does expand
access. We have to break through the traditional barriers, as
we were able to do for COVID-19, and make those changes
permanent. And there is bipartisan support on this committee
and in Congress to make that a reality. So I just really wanted
to underscore that.
And lastly, let me just mention dental care, an area that
has been particularly important to me as a Maryland Congressman
with the tragic death of Deamonte Driver in 2007 for not being
able to get access to oral health care. We have corrected that
for the pediatric, but we have not yet for the general
population, including the Medicaid population.
And I know that the administration is working on this. We
had our challenges in some of our discussions, but I would hope
that we will look for innovative ways that we can expand access
to oral health care. It is relatively inexpensive compared to
the positive results we get from access to oral health care,
and I hope that you will work with us to see how we can expand
coverage.
Secretary Becerra. Absolutely. I think we have learned that
for oral health care, we can do it, especially with Medicaid,
for pennies on the dollar.
Senator Crapo [presiding]. Thank you, Senator Cardin.
Senator Wyden and I are rotating, as we have a series of
votes on the floor, so I will do my questions now.
Mr. Secretary, as we discussed yesterday, the current law
mandates that the Medicare trustees release an annual report
updating Congress and the general public on the financial
status of the program, including the hospital insurance, or HI,
trust fund. That report is due no later than April 1st of each
year. Last year, with no real explanation, the report was
issued 152 days late. It projected the HI trust fund would
become insolvent in 2026, and we have yet to receive this
year's report, which is now already late.
Mr. Secretary, as a member of that board of trustees, do
you know what the revised exhaustion date of the HI trust fund
is?
Secretary Becerra. Senator, I know we have the latest
report, which said 2026. We are waiting for the staff to give
us the report that would let us issue to the public the latest
version of that report for the Medicare trust fund, and we will
get it to you as quickly as we can. And we look forward to
working with you, as Chairman Wyden said, in trying to move
forward with Medicare.
Senator Crapo. Well, thank you. And as a member of that
board, I would ask you if you would urge them to get moving. At
this point we have no communication from the administration
concerning the status of this year's trustees' report.
And following up on this, the Medicare trustees currently
project that the trust fund will become insolvent anywhere from
4 to 5 years from now. And other than during the first few
years of the Medicare program's existence, Congress has never
allowed the trust fund to project fewer than 4 years of
solvency without a legislative change. Acting early helps to
minimize the overall impact on health-care providers,
taxpayers, and beneficiaries.
Secretary Becerra, can you explain why the President's
budget submission fails to include a specified package of
Medicare savings proposals to address the trust fund's looming
insolvency?
Secretary Becerra. Senator, as you know, in the past the
President has submitted proposals to deal with the future of
Medicare. In this particular budget, we have some items that
deal with, for example, the incentives to have physicians
participate in value-based payment programs that will help
drive costs down.
I think the important point is, as Chairman Wyden has said,
that as we move forward in making reforms that improve and
strengthen Medicare, we should be looking to reduce costs not
benefits.
Senator Crapo. Well, I certainly wish that the President's
budget would have been much more focused on this trust fund,
and I encourage you to work with me and with others to get that
specificity outlined and implemented.
I want to move to mental health for a second.
I share the administration's commitment to address what the
budget calls ``the invisible costs'' of the mental health
crisis. That being said, for far too many of the policies that
the administration has proposed, the cost implications are just
that, ``invisible.'' Budgetary estimates and projections for a
sizeable list of provisions are just entirely unavailable. The
budget includes $102 billion in new mental health spending, but
that top-line figure fails to account for the bulk of the
Medicare expansions outlined in the proposal, which would
likely add billions if not tens of billions to this total.
Where does the administration propose finding the savings
from Medicare, Medicaid, and other programs needed to finance
this new spending without further straining our deficit, along
with our State budgets?
Secretary Becerra. Senator, first let me begin by saying
that I think each of us here has not only the priority to deal
with mental health the way we should have a long time ago, but
to make sure we have the resources to make it happen.
The President has put forward proposals in the past. One of
the things we would like to try to do is work with Congress to
make sure that we can keep this permanently in place. I can try
to give you the details of particular proposals, if you would
like, but what I can tell you is, the President is committed to
protecting and strengthening our efforts to try to have
everyone receive mental health or physical health services in
parity without any discrimination.
Senator Crapo. Well, because my time is limited, I will not
ask you to go through those proposals you just suggested you
could provide, but I would ask you to provide those. We really
need that detail.
[The questions appear in the appendix.]
Senator Crapo. The last question I have is on transitioning
beyond the public health emergency. As communities across the
country continue to return to normalcy, our Federal policies
should reflect that same shift. We have learned a lot of
lessons--telehealth, for example, is one--on things that we
should extend. But we need to give clarity on where we are
headed as we try to deal with post-pandemic health-care issues.
That means putting an end to needless and invasive mandates,
but it also means moving our health-care system onto a more
sustainable and predictable path.
We just cannot operate in a permanent state of emergency,
and we need to move forward. With that in mind, our States,
front-line providers, and working families deserve concrete
timelines and plans for exiting the ongoing public health
emergency, because we need a smooth transition.
Given the omission of any direction along these lines in
the budget request, do you expect the public health emergency
to end this summer? And could you please speak to the
administration's progress on post-emergency transition planning
across programs?
Secretary Becerra. You have pointed out something that is
critical for the American public and all of our industries, and
that is the preparation it will take once we leave this state
of public health emergency. We have committed to making sure
that we give all providers at least 60 days notice of when we
will bring down that public health emergency declaration. We
are continuing to work to make the plans for what comes next.
As I mentioned to you, the President has submitted a proposal,
and it is in the budget, that would call for what comes next.
So, we go beyond COVID-19 to look at what might come next,
the planning for that. We look forward to working with you on a
bipartisan basis to make that happen. And what I can tell you
is that everyone is seeing good signs of where we are today in
COVID. In terms of Omicron, in terms of the number of
vaccinations, in terms of the therapeutics that we have, good
signs. We hope that Congress will continue to work to provide
us the funding that lets us have that happen all the way
through this crisis. But what I can tell you is that as we move
forward on COVID-19, regardless of what happened in the breach
with other pandemics, or what we have to prepare for, but on
COVID-19 we will telegraph to you and the rest of the public
what needs to happen, and as quickly as we can.
We have telegraphed that we need to continue resources to
provide those therapies, those medicines, those vaccines that
are needed by the American public.
Senator Crapo. Thank you. Understood. And I look forward to
working with you. And I urge expeditious attention to this
issue.
Senator Stabenow?
Senator Stabenow. Well, thank you very much, Ranking Member
Crapo, and good morning. It is wonderful to see you, Mr.
Secretary. I appreciate so much all your work. There is a lot
to celebrate and be excited about in this budget.
I do want to start, though, and just say as we debate the
whole question of Medicare and strengthening Medicare for the
future, and solvency, and so on--and I certainly support, and I
know the President does, strengthening, reforming, and moving
forward to protect Medicare for Americans. But what we do not
support is the Republican plan that Senator Rick Scott of the
campaign committee for the Senate Republicans put forward,
which is to end every Federal program in 5 years and then
debate whether or not it should be continued, which of course
is Medicare, Medicaid, Social Security, and so on. And that has
been the platform put forward if the majority goes back to
Republican next year.
So, I certainly do not support that. But I do support, and
want to thank you for the fact that you announced yesterday the
over-the-counter rapid COVID-19 test at no cost for people on
Medicare. I wrote a letter urging that that happen. Thank you
so much for doing that. This is really important for our
seniors and others on Medicare.
No surprise that I want to talk about community mental
health, addiction services. I have to say, when I saw this
budget I was literally jumping for joy, because this budget is
historic in terms of finally making the investments in the
priorities that we have needed in our country for a long time,
and certainly need now after the pandemic, in community mental
health services, substance use disorder services in the
community. This is an area of great bipartisan support. So I
appreciate the chairman and ranking member putting this as a
priority.
As you know, Senator Roy Blunt and I have been working for
years to get comprehensive quality services in the community
through our Certified Community Behavioral Health Clinics,
which the President has now embraced expanding across our
country. And so I want to thank him, and thank you for that,
and I wondered if you might speak about the clinics,
particularly because there are so many things we need to do.
Senator Daines and I are leading one of the work efforts
here in the Senate Finance Committee on workforce, and we
certainly know we need the people to be there. We need
telehealth. We need a whole range of things. But if we do not
have comprehensive services in the community to refer people
to, if we do not have that available, we are never going to get
anywhere. And so I was thrilled to see the new numbers that
have come out that are even better than when we started a few
years ago with the demonstration projects.
But could you talk about how Certified Community Behavioral
Health Clinics improve care, and why it is time to make sure
every community has the opportunity to have these services?
Secretary Becerra. Senator, to you, thank you for the years
that you have devoted to this. And hopefully through this
budget, you will get to see the fruits of that labor, and
millions of American families will benefit as a result.
What the President has essentially said is, we are not
going to treat this as business-as-usual when it comes to
mental health. We have to take a different approach. And so, he
not only put forward a number of proposals to do this, but he
also put his money where his mouth is. And he has committed
substantial amounts of money, some $52 billion over the next 10
years, to transform our mental health system into one that
actually provides decent quality care for all Americans who
need it.
And so, we are going to work with you. We have a specific
priority immediately to address the behavioral health issues
for children. We are going to do everything we can to work with
States to launch the 988 lifeline that will hopefully become
like 911, but for mental health services. For those who are
contemplating suicide, we want to make sure that really
launches well. So we are working on that.
We are going to continue to work with you to see if we can
embed into our health-care system the idea that mental health
is no different than regular types of health-care services. And
it will take a lot of work. But behavioral health services,
those where we go into community settings and we provide people
with the opportunity to be cared for in their home, or in their
local community, instead of being shipped off to some
institution, that becomes critical. And that is where we are
working with you. What we are going to try to do is make sure
that we continue to bolster the support for those local
facilities and supports. And we are going to also do everything
we can in this budget to increase the salaries and wages of
those who work in those community and home settings.
Senator Stabenow. Thank you very much. And let me just say,
in conclusion, that certainly Senator Daines and I are
interested in working with you on the workforce issues that are
very important to make sure we have the personnel, the
providers, the professionals to work with people.
But I do just want to underscore one thing. We have been
working hard. We have now 435 quality clinics that are now
funded the same as physical care--you know, health care above
the neck the same as health care below the neck. And what is
amazing to me is that the latest numbers show that when you do
that in the community, we have a 73-percent reduction in people
going to the hospital, 69-percent reduction in people sitting
in the emergency room because there is nowhere for them to get
help, and a 60-percent reduction in time spent in jail.
And so it is no wonder that the sheriffs and police chiefs
across the country where we have these services are our biggest
supporters. So we can save money. We can do the right thing. We
can provide people these really important services. So thank
you. I look forward to working with you.
Secretary Becerra. Thank you.
The Chairman. Thank you, Senator Stabenow.
Senator Cassidy, who is always very helpful in working on
these health issues, is next.
Senator Cassidy?
Senator Cassidy. Thank you, Senator Wyden. Secretary
Becerra, nice to have you.
Secretary Becerra, as you know, the U.S. District Court for
the Eastern District of Texas recently ruled that the rebuttal
presumption of a benchmark rate in the interim dispute
resolution of the No Surprises Act was invalid. The judge ruled
that this, quote, ``conflicts with the unambiguous terms of the
Act,'' end quote.
Now as you know, the majority of my colleagues and I who
wrote this legislation have been sending you letters before and
after the issuance of this ruling, stating that it violated
congressional intent. Clearly it violated the plain reading of
the law. And it violated the kind of delicate balance we had
between all the stakeholders to get them to agree.
So on behalf of the administration, I guess I am asking,
would you commit to accepting the will of Congress and the
courts and finalize a rule promptly that does not include a
rebuttable presumption of a benchmark in the IDR, but rather
follows congressional intent? And when can we expect that rule?
Secretary Becerra. Senator, thanks for your advocacy on
this particular issue on the No Surprises Act. We have put in
place guidance. The CMS has put in place guidance that has made
clear that we are updating our documents and other materials in
light of the Texas decision.
But it would be difficult for me to comment more, since we
are still in the midst of that----
Senator Cassidy. May I ask, will you be appealing that
decision, or accepting it?
Secretary Becerra. That is a decision that will be made
working with the Department of Justice. I cannot give you that
answer right now, but what I can tell you is that we are
continuing to work through that litigation as best we can.
And----
Senator Cassidy. And--I am sorry--do you accept what the
judge says that it clearly violated the unambiguous terms of
the act?
Secretary Becerra. As I mentioned, we have updated our
guidance. We are doing everything to make sure we stay
compliant with the law, and we will continue to proceed
forward. We are implementing other aspects of the No Surprises
Act that were not implicated by the court's decision, and we
will move forward in making a decision where to proceed on that
particular litigation.
Senator Cassidy. Then let me go on to Medicaid, and
specifically outcomes. Maternal mortality continues to be
abysmal. Medicaid pays for 60 percent of births in our Nation.
And there is an old public health maxim: ``that which is
measured is addressed.''
Now we have a way to measure outcomes in Medicaid. It is
called T-MSIS. But it is my understanding that the method by
which that data is presented to CMS is nonstandardized. And
indeed different data sets are presented by different States,
and some in PDF, and some digital, et cetera.
And so I just gave the pregnancy outcomes, but I could give
many others where Medicaid is not coming up to where it should.
So the question is, what is CMS doing in order to kind of
better standardize both the data that is collected and
reported, and how it is reported, to make us better capable of
viewing one State versus another?
Secretary Becerra. Senator, you have touched on a--not a
sensitive subject, but a subject that absolutely needs further
attention. T-MSIS is something that has been, as you now, in
progress for many, many years. We are trying to make as much
progress as we can.
We saw with COVID how important it was to have accurate
data. And Medicaid is no different. We have to make sure we
continue to work to ensure that the States are giving us the
data we need so we can make decisions, and States can make
decisions that make total sense. And so, we look forward to
working with you as we try to move forward with T-MSIS and
getting that taken care of. But as you know, moving these
systems, these databases, into a different shell is difficult.
Senator Cassidy. I accept that, but it could just be asking
them to report the same issues. You know, if one State is doing
this, and no other State is doing that, then there is no way to
have a comparator.
Secretary Becerra. And it is easy to ask, but it is hard to
get responses unless you have more than just a carrot to ask.
And so we have tried. We learned the lesson with COVID that
some States have been very good about reporting data, even that
data that they are not required to report. Other States have
not. And it makes it difficult to make those full decisions, as
you mentioned.
Senator Cassidy. So it sounds like this committee needs to
give you some tools in order to address that.
Secretary Becerra. We would love to work with you on that.
Senator Cassidy. That sounds great.
Next, talking about mental health, several issues. One is
the RAISE initiative, which is the Coordinated Specialty Care,
which Congress has given money for.
When I look at my own State, however, only two of my cities
have actually begun it. And again, just for context, this is a
wrap-around set of services so that when a young person has her
first psychotic episode, those services are there so that that
first is her last. But apparently it is so difficult to
coordinate the different agencies that apply this, so that it
has limited effectiveness and limited reach.
So my questions are, what steps is the administration
taking to increase access to the Coordinated Specialty Care,
and how is the administration prioritizing programs that serve
this population like Medicaid and SAMHSA to work better
together in order to achieve more people being enrolled in
Coordinated Specialty Care?
Secretary Becerra. And, Senator, you are raising one of the
areas where it is clear that we need to do more, because there
has not been that type of coordination, whether in the public-
sector side of health care, or in the private-sector side. And
what we are trying to do--and that is why the President's
budget reflects that priority--is to make sure that we give
everyone the tools, not just our agencies, but the private
sector the tools they need to make it happen.
We also put some requirements out there so that we could
ensure that we are actually providing the care that people
need.
Senator Cassidy. There must be coordination, because
apparently it is so discoordinated it is just not happening.
And like Pogo said, ``We have met the enemy, and he is us.''
Secretary Becerra. Yes, I know. It is very disjointed. And
trying to get all those different stakeholders to work
together--they will tell you it costs money. We say it is going
to benefit them and actually save them money in the long run.
But it is getting them there. And we might need to provide some
incentives to help push this along a little faster.
Senator Cassidy. Okay, I yield.
The Chairman. Mr. Secretary, just on this point that my
colleague has made with respect to the Medicaid data on
postpartum care, I am very interested in working with you and
the Senator on this. We ought to be getting better data on it,
because the need is so urgent. We ought to be able to ring
every bit of value out of those health-care dollars.
Secretary Becerra. And, Senator, with the proposal to
extend postpartum care to 12 months, we should be able to
collect not only more data, but better data for a long period
of time.
The Chairman. That was almost going to be my next sentence,
but you said it much better.
Okay, Catherine Cortez Masto?
Senator Cortez Masto. Thank you, Mr. Chair.
Mr. Secretary, it is great to see you. Thank you for
joining us.
First and foremost, let me just say that I want to thank
you and the administration for the clear prioritization of
mental health in this budget. I am sure Debbie Stabenow said
the same thing. It is one of the issues I hear most from
Nevadans, whether I am talking with folks in the rural counties
about infrastructure, or in Clark County about education. So
often the conversation comes back to mental health. There is a
lot in the budget to get to those concerns, including
investments in the workforce, expanded coverage of therapy,
better enforcement of mental health parity. I mean, there is a
long list of them. So I thank you so much for that.
One thing I do want to talk to you about is the health
crisis piece of it. You talked in your opening about setting up
the 988 hotline in July, which I think is fantastic for people
in crisis--whether it is a suicide hotline or a mental health
crisis, or any type of crisis--to call.
Let me ask you this. My biggest concern, though, is--and I
know this is happening in Nevada; we want to set up the
hotline. But once they call, where do they go if we do not have
a structure in place for services, essential services, to
really provide for individuals in need?
So can you talk about the investments in mental health
crisis services that you have proposed in this budget? And how
will they help folks who need additional services on top of
988? In other words, at that crisis mode when they are calling,
what types of services are you looking at? Because this is an
area where Senator Cornyn and I have focused on providing and
building up that essential crisis mode of services that we
need, not only in Nevada but across the country.
Secretary Becerra. Senator, thank you for the question, and
for all the work that you have done on this particular subject.
As you know, the current system is a patchwork. We have
different phone numbers that people can call to try to get help
when they are facing a mental health crisis, or if they are
contemplating suicide. 988 is our way--thank you, Congress--for
helping us get these resources to bring it all together. It is
almost a one-stop shop. You get to make one call, 988, and if
you are facing a point of perhaps considering suicide, you are
going to get services.
To your point, we are going to have call backup centers so
that if a particular State is getting a lot of calls, there
will be a backup center that will be available to take that
call so folks are not waiting with busy signals or being put on
hold to get services.
I mentioned earlier in a discussion with Senator Stabenow
how we are going to increase our investments in community and
behavioral health services. We are investing, in the
President's budget, more than $200 million to make sure that we
can provide those local community health centers, mental health
centers, to people so that there is place where they can go. We
can direct them, if they do indeed have a mental health-care
crisis.
So there are a number of things we are doing, but
ultimately what we have to do is glue together all those folks
who are doing this work throughout the country so 988 will work
really well.
Senator Cortez Masto. Well, thank you. And I appreciate
that.
The other thing--and I look forward to working with you. I
know for Senator Cornyn and I, this is an issue that we both
care deeply about, and we've got to really address bringing the
essential services to someone when they reach out to that
hotline.
One of the other areas of focus for us is to make sure that
there is available to everyone insurance coverage to cover when
they are reaching out in the crisis mode. So I am hopeful--can
I get a commitment from you that you will be willing to work
with us on our legislation to make sure we are providing those
essential services right at the crisis mode when they are
making that call?
Secretary Becerra. Absolutely. We are committed to making
mental health-care parity the law of the land.
Senator Cortez Masto. Thank you.
The other thing that I see in here, not just in Nevada but
across the country, is the workforce expansion piece, when it
comes to behavioral health.
There is an emphasis I know, in this budget, on the great
work that allied health professionals do to keep their
community safe, which is especially true in behavioral health.
Can you explain more about the provisions in this budget that
would expand coverage of community health workers? Because it
is something that I hear all the time that we need to do, and
this budget and what this administration wants to focus on is
really addressing that need.
Secretary Becerra. Well, I mentioned the more than $200
million that we are going to be investing in Certified
Community Behavioral Health Clinics to make that service more
available locally to people. We are also, in this budget,
proposing that we help States be able to provide better
compensation to those who go into this workforce, the
behavioral health workforce. It is often one of the most
underpaid areas of coverage, yet it is one of the most
indispensable areas of the health-care services.
We are going to continue to work with those local programs
that exist to offer them new innovations. We, for example,
changed completely--we are going in a different direction when
it comes to how we treat substance use disorders. We want to go
with the evidence. We want to go where people are. And we want
to not only save lives, but keep people healthy.
So we are talking a lot more about harm reduction, not just
about saving a life.
Senator Cortez Masto. Well, thank you. And I know my time
is up, but it is essential, because you are also opening the
door for other specialists to be able to access and get
services paid through Medicare. And these are folks who work in
the behavioral health sector. So, thank you very much. I look
forward to working with you, Mr. Secretary.
Secretary Becerra. Thank you.
The Chairman. Thank you, Sentor Cortez Masto.
Senator Menendez?
Senator Menendez. Well, thank you, Mr. Chairman. Mr.
Secretary, it is good to see you.
The Maternal, Infant, and Early Childhood Home Visiting
Program, known as MIECHV, is a critical resource for young
families that improves maternal and infant health, school
readiness, and family self-sufficiency. It reduces abuse and
neglect, and it connects families to community resources and
supports. It is an evidence-based program that has shown the
real impact early intervention and support can make for young
families.
Unfortunately, the last reauthorization did not include a
funding increase, and we know that just over 3 percent of high-
priority families were served through home visiting pre-
pandemic. While I am pleased to see support for expanding
MIECHV in this budget, my hope and goal is that this program--
which members on both sides of the aisle support--sees a
meaningful funding increase in this year's reauthorization.
So, can I have your commitment to work with me and all of
our MIECHV champions on this committee to make the critical
investments in this program so that families can continue to
get the support they need?
Secretary Becerra. You have my commitment, Senator.
Senator Menendez. Thank you.
Let me turn to the question of title 42. DHS intelligence
officials are predicting an influx of migrants arriving at the
southern border in the coming months. This is a seasonal trend
matter, but it is also about the much-anticipated end to title
42.
Title 42 is being used to evade our asylum laws. We have a
law on the books. It is our international, not only our
domestic obligation. And it was abhorrent under President
Trump, and it is abhorrent under President Biden.
Some of my colleagues who somehow think that it should be
extended are making a huge mistake, because all title 42 does
is, it has migrants making multiple efforts to cross versus
knowing that there is finality in an adjudicated asylum claim.
So how is HHS preparing for the likely increase in
unaccompanied children who will be arriving at our southern
border this summer?
Secretary Becerra. Senator, thank you for the question. We
are in the process of projecting what our needs will be. I want
to thank you and the members of the Senate and the House for
providing us with additional resources to deal with the
unaccompanied children who have come into this country, who are
going through the asylum process.
We have stood up as many of the licensed facilities as we
can. Those licensed facilities that care for these children are
separate and distinct from the care facilities that offer
services, for example, under foster care for our kids from
America. But we have worked with that universe of licensed care
providers to make sure we can offer these children, during
their temporary stay with us, the best care that we can afford
to provide them.
At the same time, we do prepare, in the event that we have
to stand up additional facilities, those that can provide the
emergency care necessary so that DHS, when they must transfer
those kids over, will have a place where they can stay
temporarily.
Senator Menendez. So let me ask you this in that regard.
Last spring, very concerning reports emerged regarding the
conditions for unaccompanied children housed in HHS emergency
intake sites. And at that time, the Department officials
expressed their intention to depopulate and close these short-
term facilities as soon as possible. However, as of April 1st,
there were still two emergency intake sites open, housing
approximately 2,100 children. Is the Department still committed
to closing these emergency intake sites and placing
unaccompanied children with long-term shelters in your licensed
care provider network?
Secretary Becerra. That is the goal, Senator, because it is
required by a court decision as well. And so we make every
effort that every spot, every slot, every bed that we can find
that is under a licensed care facility, we use. And because we
do not have sufficient numbers--in previous years, many of
those licensed care facilities disappeared because the system
was dismantled by the previous administration.
We have worked hard to build it up, to increase the number
of licensed care facilities. But when there are not enough, we
still have the obligation to care for these children. That is
when we do stand up those emergency facilities.
Senator Menendez. Okay. And then we have a commitment by
the President to give refuge to 100,000 Ukrainians. Is the
Department making preparations for that as well?
Secretary Becerra. We are, Senator. And thank you again for
the resources to make that possible. Just as we provided that
refuge for the 68,000 or so Afghani refugees who have come
through, we will be prepared to do the same for those who come
from Ukraine.
Senator Menendez. I will close simply by saying I am
disappointed that our COVID package does not include any
international assistance. We cannot meet the President's goal
of helping to vaccinate 70 percent of the world by September if
Congress does not include any amount for the global VAX
initiative. And you know, diseases and viruses know no borders.
We cannot hermetically seal ourselves off. It is in our own
interest to do this, and I hope you and the administration will
continue to advocate for it.
The Chairman. Senator Menendez, before we go to Senator
Carper, let me just say I very much appreciate your points. And
especially that last one. The fact of the matter is, the main
street in New Jersey in a community, or the main street in
Oregon in a community is affected by these health practices
that go on around the world.
The world keeps shrinking as a result of modern
communications and modern transportation. And even if you do
not accept the moral case, which you and I, I think, feel
strongly about, just from a financial standpoint, a purely
financial standpoint, it is just urgent business to make sure
that these international health programs get funded, because
they, in fact, are main streets.
Senator Menendez. Mr. Chairman, I couldn't agree with you
more. This is a national interest and a national health
security interest. So to me and my operation in my office, this
would be what we call a no-brainer.
The Chairman. Yep. Well said.
Okay, Senator Carper, I think you are online.
Senator Carper. Mr. Chairman? Tom Carper. Am I up now?
The Chairman. We can hear you, Senator Carper.
Senator Carper. All right; thanks so much.
I would like to start off with just a quick refresher on
the Affordable Care Act. For those who maybe do not know or do
not remember, in 1993 Republican Senator John Chafee introduced
legislation that proposed an individual mandate and the
establishment of an insurance pool. That bill looked a lot like
the Affordable Care Act. In fact, it had over 20 Republican co-
sponsors in the Senate, some who still serve today, including
on the Finance Committee.
Fast forward to 2009, my first year as a member of the
Finance Committee and the first year of a new administration.
Our new President called on Democrats and Republicans to try
anew to achieve what previous Presidents had talked about for
more than half a century. But instead of coming to the table
and pursing a productive discussion about how we could expand
access to health care for millions of Americans, in the end
Senate Republicans chose not to engage. But the President and
the rest of us soldiered on and finally passed this historic
law.
I might add that Mitt Romney, who was then Governor of
Massachusetts, actually took the handoff from Senator Chafee
and 20-some Republicans and actually created in the State of
Massachusetts Romneycare, which is very much consistent with
what we have done with the ACA today.
I will be the first to admit that the Affordable Care Act
is not perfect. Very little that we do around here is perfect.
It wasn't when we first passed it, but our challenge has always
been, how do we improve the health-care system for more
Americans?
And, as a result of the ACA, we were able to establish
marketplaces in every State for people who did not have
insurance to get coverage on the exchanges. Folks who were low-
income could benefit from a sliding scale tax credit. Another
important provision said if you are a health-care insurer and
you want to stop people from getting coverage because they have
a preexisting condition, you can't do that. You just can't do
that.
That turned out to be a big part of the foundation of the
Affordable Care Act. And the stuff that our Republican friends
are most critical of is, to be honest with you, a lot of their
stuff. So go figure.
Secretary Becerra, in your testimony you mentioned that a
record 14.5 million people signed up for the 2022 health
coverage open enrollment. A little over a year ago, President
Biden signed the American Rescue Plan Act into law. It has
continued to make coverage through the ACA more affordable for
families, and they average about $2,400 on their annual
premium. Four out of five consumers find quality coverage for
under $10 a month.
Think about that: four out of five consumers finding
quality coverage for under $10 a month. And guess what? The
uninsured rate has fallen as a result. The ACA was not perfect.
It took a while, but it worked, and millions of Americans have
benefited because of our efforts to better our health-care
system.
And there are still ways we can continue to fix it, and
hopefully Democrats and Republicans will be working together.
Mr. Secretary, again welcome, but would you elaborate on
how the President's budget request continues bolstering the
health insurance marketplaces to ensure that every American has
the opportunity to seek out health coverage that works for
them? Mr. Secretary, welcome.
Secretary Becerra. Senator, thanks for the question. And
thanks for all the work in all the things you just pointed out.
We are going to continue to try to break records when it comes
to the Affordable Care Act. The President has proposed the
continued work to have navigators out there to help those
Americans who did not sign up for a plan--and a very affordable
plan as you just pointed out--under the Affordable Care Act's
open enrollment period.
Last year, the President extended a special enrollment. We
got over 3 million Americans to sign up who had not signed up
before. And during the most recent open enrollment period, what
we saw, as we said, was the record numbers: 14.5 million. We
are going to continue to work on that. We are going to continue
to do the work we can, as you may have heard, on mental health,
how we try to expand services there and behavioral health
services. So, we are going to continue to try to take this to a
different level where we know that there are Americans who
still do not have coverage, are not getting the services that
they need, and as a result are suffering.
We look forward to working with you, but the President's
budget makes historic investments in areas that have for too
long been neglected, including for example in Indian health-
care services where, for the first time, you are seeing a
budget that not only proposes to make that funding mandatory so
there is never a drop in services, but also to do a long-term
10-year commitment to get us to where we really should be
going.
Senator Carper. And one last quick question. Last month,
you and Secretary of Education Miguel Cardona launched a joint
department effort to expand school-based health services,
something that we are big on in Delaware, ensuring that the
children have the health services and supports necessary to
build resilience and thrive. It's clear the budget demonstrates
our shared commitment between the administration and Congress
to tackle shortfalls in mental health care on a bipartisan
basis.
My question: to that end, how can Congress partner with the
administration to better provide resources and support to
schools? How can we provide further guidance on the Federal
funding available for school-based physical and behavioral
health services, including how Medicaid can support the
delivery of these services? Just briefly, please.
Secretary Becerra. Sure. The President has asked us to work
and coordinate so that we are not doing things in separate
silos. So the Department of Education and HHS are working
together to make sure children have access to the best services
they can, oftentimes in schools, and we will look forward to
working with you, because those schools are in your States, in
the congressional districts. You know best how to make sure
that that happens, so we will work with you.
Senator Carper. Colleagues, and Mr. Chairman, in the State
of Delaware when I was Governor, we decided to put a school
nurse in every public school in Delaware. We also decided to
put a wellness center in every high school in the State of
Delaware. And we are now putting wellness centers in our junior
high schools in the State of Delaware. All of which works, and
we partner with local communities, school districts, and the
Federal Government on this to find out what works, and to do
more of it.
The Chairman. Thank you.
Senator Carper. Thank you, sir.
The Chairman. Thank you, Senator Carper.
Senator Warner is next.
Senator Warner. Well, thank you, Mr. Chairman. I see my
good friend Tom Carper there was going through his litany of
achievements as Governor. I will not try to match him on that,
though I have some good stories as well.
Secretary Becerra, it is great to see you, at least
remotely, and I want to thank you for what you and the
administration are doing on dealing with the family glitch in
the ACA, and the good work we all have been trying to do on
implementation.
I want to hit a couple of subjects fairly quickly. One,
first, is cybersecurity. This is an area I have been deeply
involved in. I chair the Cybersecurity Caucus. The chairman
here is a great member of the Intel Committee we are on, which
I chair. We have been working and slowly moving forward. We
have finally got some de minimis security requirements in for
Internet of Things devices.
We recently passed and signed into law a cybersecurity
reporting requirement. Literally only 30 percent of the
cybersecurity incidents are even reported to the government.
And that is not to expose; we give confidentiality to those
individuals reporting, and some limited immunity. We have to
make sure we can share with other members of the private sector
to get this word out, and I think we can all expect,
unfortunately, still to see Russia activate some of its very
real cyber-capabilities in the coming weeks and months.
So I want to talk about cybersecurity as it deals with the
health-care field. Obviously this is extraordinarily sprawling.
I find that--I have been working on some comprehensive
legislation here to look at cybersecurity in the health-care
field broadly.
So, Mr. Secretary, I would like you to not talk about what
you are doing as Secretary to protect HHS's assets, but more
how HHS can work with all of the providers, hospitals, other
pieces, device manufacturers. There is a long litany that makes
up the health-care field in particular when we think about all
of the smaller, in many cases legacy devices that may have some
cyber-vulnerability. What do you see as HHS's role in this? And
how do you coordinate with CISA and all of the other various
components that are grappling with cybersecurity?
Secretary Becerra. Senator, great question, because most
people do not think about this. At HHS, one of the things we
are going to do is move everyone, not just HHS but everyone in
the private sector as well, towards risk-based decision-making,
so that they are taking into account what might happen, not
waiting until it does happen. We are asking people to take a
look at what has already been done. There are a lot of best
practices that we can learn from that will not cost that much
to deploy, because somebody else has spent the time and made
the investment to make it happen.
And I think you can help with this; the Senate and the
House can help with this to make sure the administration can
provide incentives in the private sector to move people in a
particular direction, to get them to think more about this
risk-based decision-
making model.
And so, there are a number of things we can do, and I look
forward to working with you.
Senator Warner. Yes, I would like to pursue that, because I
think we particularly see smaller hospitals, rural hospitals
sometimes, make the tradeoff that cybersecurity is not that
important until they get threatened with ransomware and then
end up paying a much higher price. And that kind of merges into
my next question.
I think this question was also raised by Congressman
Fleischmann of Tennessee in your House hearings. And this goes
to the area wage index questions. We see a real challenge about
providing rural health care in small hospitals. I know the
chairman has the same problem in Oregon. CMS, during COVID,
provides some relief, but as you know, that is now being
challenged in court on dealing with the area wage price index.
I have legislation, bipartisan legislation that would
increase the Medicare reimbursement rates for about 850 rural
hospitals around America, many of these hospitals that
otherwise might be faced with closure. We have seen a dramatic
increase in the closure on this wage index to kind of bring it
a little bit closer to suburban and rural rates.
I know you were asked this and are supportive of rural
health, but is this an area where CMS can do it on its own? Or
do you think we actually need the kind of legislative,
bipartisan fix that I proposed?
Secretary Becerra. Our authorities are pretty expansive,
but someone is always going to take the time to challenge us in
court. It really does behoove us to try to work with you in
Congress to try to make sure that we address this the right
way.
We are making specific investments into rural communities
on health care. But what you are speaking to really is, across
the board, trying to make sure that we do this the right way.
So we would look forward to working with you on this.
Senator Warner. Mr. Chairman, I won't get to my last
question. I just do think that this legislation needs the
review of this committee. It would produce that national wage
floor minimum, and I think that is one of the ways that we can
guarantee rural health going forward.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Warner. We will be working
with you on these rural hospital issues.
Senator Barrasso, I am going to run and vote. You are next,
and Senator Crapo is back, so I appreciate all my colleagues'
cooperation on this hectic morning.
Senator Crapo, Senator Barrasso is next.
Senator Barrasso. Thank you very much, Mr. Chairman. Mr.
Secretary, thank you.
I wanted to follow up on something that Senator Crapo asked
a little earlier, and that is in terms of the Department of
Health and Human Services implementing several emergency
waivers for Medicare and Medicaid programs in response to the
COVID-19 situation. Some of the waivers have granted patients
more flexibility, like enhanced access to telehealth. Others
have ensured that providers could do their jobs with less red
tape, and with more financial certainty. All those things are
positives. The world today is very different than it was when
the virus first hit our shores. Cases, deaths,
hospitalizations, are right now much, much closer to pandemic
lows.
This is why, in Wyoming and most of America, life has
returned to normal. I think it is why we must plan for the end
of the public health emergency. And for us here in Congress,
that means we have to ensure that providers and patients do not
unexpectedly have the rug pulled out from under them after
these flexibilities that, I think, have been helpful in
Medicaid and Medicare--after those end.
So will you commit to providing detailed and specific
information to Congress on those emergency flexibilities that
you did use in Medicare and Medicaid and the CHIP program as a
result of the pandemic?
Secretary Becerra. Senator, I am absolutely committed to
working with you, because a lot of those authorities will
vanish, and we need to work together to make sure we deploy
what we know has worked.
Senator Barrasso. And will you provide detailed information
on emergency waivers that your department believes Congress
should extend, or make permanent beyond the public health
emergency?
Secretary Becerra. We look forward to working with you on
that as well.
Senator Barrasso. Great. Additionally, has your department
specified plans to ensure that providers and patients are aware
of some of the changes to Medicare, Medicaid, and the CHIP
program when the emergency actually ends?
Secretary Becerra. We have, Senator. But, you know what?
You could help us a great deal if you continue to let your
State leaders know that we are trying to make sure we are
communicating everything that is around the bend. And so,
whether it is the Medicaid wind-down, or whether it is what
happens to those authorities we have for telehealth, we want to
make sure that everyone has full sight and that we are working
together to make sure we accommodate.
Senator Barrasso. And Senator Warner before me talked about
rural hospitals, and I want to continue on that because, as you
know, I practiced medicine in Wyoming for over 20 years. And we
have discussed previously ensuring that patients in rural
America have access to health care in a very--well, it is a
personal priority of mine to make sure people get what they
need in rural communities. And rural hospitals have really been
on the front lines of the pandemic. Those facilities provided
essential care when their communities needed them the most. And
despite their best efforts, many rural hospitals continue to
remain under threat.
According to the University of North Carolina, 19 rural
hospitals closed in 2020; 138 have closed since 2010. And the
closure of a rural hospital means people have to drive much
longer distances to receive essential health care. In a medical
emergency when seconds count, driving these long distances, and
most certainly in the dead of winter, can have deadly
consequences. And when a rural hospital closes, it really has a
significant impact on both the health and the economy of the
local community. When a rural hospital closes, it is much
harder to attract and maintain businesses, teachers, doctors.
There are all sorts of impacts on the community.
So I am concerned that your budget does not contain a
comprehensive strategy for halting these rural hospital
closures and building a sustainable rural health-care delivery
system.
Can you discuss with me, please, how the Department is
going to address this critical issue of rural hospitals?
Secretary Becerra. Senator, let me try to persuade you that
there is not only an investment made in this budget, but that
there is a plan here. Let me, for example, mention the $374
million that we included in the budget that would be used
specifically to improve access and quality, as well as
coordinate care in our Nation's rural communities.
We are investing more money in trying to train those
health-care practitioners in rural settings. So we are giving
more money to some of those rural community facilities that can
then house those future doctors, future nurses there. We know
this from the studies that if you start your practice in a
particular community, you may end up staying there. And so,
what we want to try to do is drive people who are going through
medical school and so forth into some of these rural
communities so that they start practicing there, and hopefully
they stay.
There are a number of other investments that we are making,
but clearly with the Provider Relief Fund support that we got
from Congress, we have been able to try to shore up a lot of
our community health-care clinics, our hospitals, in some of
these rural settings.
Senator Barrasso. Thank you.
Thank you, Mr. Chairman.
Senator Crapo [presiding]. Thank you.
Senator Thune?
Senator Thune. Thank you, Mr. Chairman.
Mr. Secretary, earlier this year a number of colleagues and
I sent a letter requesting that you rescind a rule that
requires everyone in Head Start facilities to wear a mask,
including children 2 years old and older, even when they are
outside on the playground.
Though there is an injunction against this rule in several
States, the rule has yet to be withdrawn. As the administration
plans to drop title 42 public health measures at the border and
continues to modify other recommendations, why hasn't HHS
decided to rescind this Head Start rule?
Secretary Becerra. Senator, thank you for the question and
your interest. Most of those kids in Head Start have not had a
chance to get vaccinated. There are still families that are
very afraid of what could happen to one of their loved ones.
Those who say that children do not get COVID should talk to
the hundreds of families across America who have lost a child
under the age of 5 as a result of COVID. We are driven by the
science when it comes to the work that we do on COVID, and we
will continue to do everything we can to make sure we are
protecting every human life in America, including our children.
Senator Thune. The transmission of COVID-19 is really low
among kids, particularly young kids, and it seems like masking
toddlers on the playground seems completely unnecessary, and I
would say that even the World Health Organization has concluded
that there is not any particular benefit, health or safety
benefit, to masking kids under 5, and especially when they are
on a playground. I mean, it just seems to me at least when you
are outside and kids are playing--we know there are impacts,
adverse impacts, with masks when it comes to their
socialization skills, and to their learning skills.
But it just seems like when you even have the World Health
Organization saying that masks for toddlers, or for children
under 5, are not necessary, that we are really creating
problems that do not need to exist.
So let me ask you this: when do you foresee that rule being
rescinded?
Secretary Becerra. You are talking about the public health
emergency?
Senator Thune. Or the masking.
Secretary Becerra. Masking?
Senator Thune. Yes.
Secretary Becerra. So the masking requirements, and the
instructions and guidance on that, as I mentioned, are driven
by the science. When our scientists tell us that there are
needs to take precautions because masks have been proven to be
safe and effective, we issue those guidances, sometimes
requirements, to move in that direction.
Once we see that the need for those types of protections is
no longer necessary--no longer there--we will move forward in
trying to make the adjustments. But while there is a chance to
provide the most safe and effective way to keep a loved one
alive, we are going to do that.
Senator Thune. Well, again--and not to overstate this--but
it does, I think, to me it just seems illogical. And
particularly given when you weigh the consequences of the
impacts on these kids--and they get adverse impacts, these
kids, from wearing masks all the time. When you try and weigh
this on the scale, it just seems like it clearly comes out on
the side of common sense dictating this.
I understand your wanting to follow science, but you do
have some scientists--you have the World Health Organization
saying that masking for children under 5 is not necessary. And
so, it strikes me at least that this is one of those
requirements that is just a real overreach at a time when
parents, a lot of parents at least, and a lot of kids are
struggling. They are struggling with learning. They have gotten
behind. And I think a lot of it is associated with the impact
of masks and their ability to socialize with other kids, and
also to, you know, to be able to learn at the fastest rate
possible.
So I would urge you, encourage you, given where we are with
the pandemic, that this is one--particularly when kids are on
the playground, when they are outside--that makes no sense to
me.
Very quickly--I do not have a lot of time--but we talked
last year at the budget hearing about the Department's
authority and resources to ensure the advancements we have made
on telehealth during the pandemic, that those are not lost. And
I see again that this budget does not describe administrative
actions the Department plans to take on Medicare telehealth,
nor does it include a full legislative proposal for Medicare.
There is a single reference to extending pandemic
flexibilities, but we need data. We need details on what you
can and plan to do administratively so we can focus our efforts
accordingly. And it would help to have more certainty on the
expected length of the emergency for sure, but can you tell us
some specifics on what you foresee the Department doing
administratively on Medicare telehealth at the end of the
emergency?
Secretary Becerra. Absolutely, Senator. Let me start by
saying, first, thank you for extending for 5 months the
authorities we have on telehealth. We would like to work with
you to extend coverage for services for patients to be able to
use their home as the originating site for that health-care
service.
We would like to continue to offer those Federally
Qualified Health Centers and rural health clinics the ability
to provide the services from distant sites. We would like to
move towards payment parity for behavioral health telehealth
services so that we can continue to have providers willing to
do that. There is strong evidence that telehealth has been
effective, or just as effective as standard in-person treatment
in parts of the country. We would like to be able to do audio-
only access for patients whose circumstances would necessitate
that they get audio services instead of having to worry about
trying to reach a particular provider in person.
So there are a number of things we would like to do. Again
with the authorities that you could grant us, we could try to
keep those extended services in place.
Senator Thune. My time has expired. Thanks, Mr. Chairman.
Senator Crapo. Thank you.
Senator Whitehouse?
Senator Whitehouse. Thank you. Welcome, Mr. Secretary. It
is good to be with you.
A couple of quick topics. First, the most significant issue
that our Rhode Island hospitals are facing right now is nursing
and health-care workforce. And this has two dimensions. One,
they are unable to operate at full capacity and are having to
stop procedures because they simply do not have the workforce
to operate. And second, because of, I would call it a plague of
contract nursing, where they are having to spend spectacular
amounts of money for services that did not cost anywhere near
as much before.
What are you doing to help hospitals that are facing these
twin pressures? Should there be some form of special
reimbursement for the added nursing costs so we can get them
back on their feet again?
Secretary Becerra. Well, one of the principal tools that we
have used for some 440,000 providers throughout the country is
to provide them with reimbursement of some of their claims
relating to COVID. That Provider Relief Fund which you and your
colleagues helped to put in place, $186 billion worth, has
helped us provide substantial support to some of these
facilities that are suffering from some of these conditions.
Unfortunately, that----
Senator Whitehouse. They kind of burned through that, so
the problem is still there.
Secretary Becerra. It makes it tough, because----
Senator Whitehouse. Would you mind following up with a--
treat that as a question for the record and let me know what is
being planned?
Secretary Becerra. Of course. We look forward to working
with you.
[The question appears in the appendix.]
Secretary Becerra. We need authorities and resources to
continue to help some of those providers.
Senator Whitehouse. With respect to support for people who
have addictions, we have always done prevention. We have always
done treatment. It was only through CARA that we started
providing recovery support. And because it had never been done
before, we are kind of in a stranger-in-a-strange-land scenario
with no real guideposts as to what works and what does not
work.
Are you comfortable with the degree of flexibility that you
have allowed for the recovery services to let people find their
way, since there is not a huge track record of success and
data, because we have never done this before?
Secretary Becerra. Senator, you have touched on something
very important. The data, the evidence--and usually at the
Federal level, we are the last to try to move in a direction
that could help save a life or keep someone in better health.
But what we have done with our new strategy on drug use is
move away from the old paradigms. We are letting go of some of
those taboos. We are looking at the evidence. And so, for
example, fentanyl strips. Some people say that if you give
people access to a fentanyl strip that lets you determine
whether the drug you are about to take has fentanyl in it--
which has caused some of the largest number of drug overdoses
that we have seen--that it helps promote drug use. We think it
helps promote saving of a life. The evidence shows it. So we
are going to go in that direction. Clearly we are going to try
to help those who are moving in a faster direction to help
treat, but we are also going to move toward prevention.
Senator Whitehouse. The point is, I think that it is
important to be flexible with the recovery stuff, because
people are having to kind of learn while doing, and report in.
And later on, when there is a body of research that shows what
works and what does not work, then I think you can narrow the
aperture a little bit. But right now, I hope you continue to
provide support, because it has always been underfunded before.
Secretary Becerra. We are moving as best we can.
Senator Whitehouse. The last point: you focus in the budget
on what you call program integrity efforts, which have been
around for a long, long time. I was the U.S. Attorney in Rhode
Island, and Attorney General Reno put health-care fraud and
program integrity at the top of her policy priorities. And it
has been at the top of policy priorities for a long, long time.
And I worry that there is just not a whole lot of ``there''
there because it has been focused on for so long. And once you
actually get into the cases, they are hard to make.
So I think putting that as a priority with respect to
lowering health-care costs is a strategic mistake, compared to
focusing on delivery system reform--trying to get away from
fee-for-service; trying to expand ACOs; trying to make sure
that quality metrics are in place across the system. I think
that probably fee-for-service is the biggest monster that is
driving health-care costs right now.
We talked a lot during the Obama administration about the
triple aim, and I would urge you to go back to that. In this
committee, even when we were in our highest level of Obamacare
hostilities, the parts of that bill that related to the
delivery system reform--the ACOs, CMMI, payment reform--those
things have been very popular, and there has been a lot of
success across the country with actual cost savings.
So I would encourage you, particularly as we close in on a
period when Medicare might get cash-negative, to really make
that a focus. I think you may find that program integrity is a
bit chimerical as a savings device.
Senator Becerra. Senator, we agree with you that delivery
reform is absolutely important, and we are working on that. But
let me just persuade you that we can walk and chew gum. As a
former Attorney General in the State of California, we did work
on program integrity. There is abundant fraud out there, and we
can tackle it.
And if we do not, then those who are doing it think they
can get away with it, and will do more. And so I think we can
walk and chew gum and do both areas of reform.
The Chairman. I thank my colleague.
Senator Portman is next, and he is online.
Senator Portman, are you online?
Senator Portman. Thank you, Mr. Chairman. Secretary
Becerra, thank you for being here.
I would agree with what my colleague, Senator Whitehouse,
just said regarding the Comprehensive Addiction Recovery Act
and its implementation, particularly on the treatment side. We
just did provide more funding for that in the Omnibus, and
unfortunately, with the opioid crisis we have and broader drug
prices, we need to focus even more on the demand side.
I am going to talk to you a little about that today. We
have legislation, also with Senator Whitehouse, called the
TREATS Act. Basically, it permits us to do something that is
working, which is to provide prescription drugs, medication-
assisted treatment in particular, MAT, without having to go to
a personal, in-person visit first. So it is telehealth, and it
has worked incredibly well during an otherwise very difficult
period during this pandemic. This is one thing that emerging
research shows is actually helping, particularly with regard to
Suboxone. And it is permitted under a waiver that we have
currently, but the waiver is--although again very important,
and back home folks are calling it a game-changer--the waiver
is temporary. In fact, the waiver ends when the public health
emergency ends. And I am concerned, as we have been talking
about today, that the public health emergency would not
continue.
So what do we do about it? Well, one is, you have the
ability through HHS to issue a rule on this and permit this
kind of telehealth. Again, the research is out there. It works.
In 2008, you and I both supported it--actually, I was out of
Congress at that time, but you were still in Congress--what was
called the Ryan Haight Act, which gave DEA the authority, and
HHS the authority to issue a rule. Ten years later, they had
not done it, so Congress in 2018 said, ``Please do it,'' and
then again in the Appropriations Act of 2021.
So here we are 14 years later, and still we do not have
this rule out. Senator Whitehouse and I are frustrated because
we cannot get technical assistance from your folks on our
legislation, the TREATS Act. But my view is, if we cannot get
technical assistance which we would like to have, at least if
we could get this rule out, it would be helpful to have an
administrative decision.
So my question to you today is, would you commit to working
with Congress to ensure we do not have an interruption in this
treatment, particularly the really important treatment like
Suboxone via telehealth, when the public health emergency ends?
Secretary Becerra. An absolute commitment, Senator, to work
with you on that. And I have some of my team here, and they
heard that admonition you just gave about not being able to get
certain technical assistance. We will make sure that whatever
you need, we will try to get it to you.
And as you know, one of the things that makes it more
difficult is, it is not just up to HHS. We have to work with
our drug enforcement partners, and we look forward to your
support in trying to get together all the different agencies
that have to have a say in this.
Senator Portman. Well, thank you. I appreciate it, Mr.
Secretary. And we will follow up with you right away on that.
It has been 2 years, by the way, of us trying to get the
technical assistance. And in any case, you know you have the
ability to do the rule, and I think it is really important that
we have a law eventually. But immediately, you need to let
people know they can continue to get access to this medication-
assisted treatment.
Title 42 and the border--this is a mess. As you know, we
have 7,000 people a day coming across the border, which is a
historic number. These are unlawful migrants coming to the
border and being allowed in, typically under the asylum rules,
7,000 people a day. We are turning away about half the people
under title 42, so another 7,000 people a day would logically
be coming in addition to the current 7,000. However, DHS has
told us it is more likely to be something like 18,000 a day
because more folks will come to the border. They are already
doing so, apparently, knowing that this title 42 is going to be
expiring.
That is going from a crisis to a catastrophe, I guess you
could say, because that is over half a million people a month
coming across our border who are unlawful. So this is a huge
problem. It exacerbates an already very difficult issue we
have. Obviously, we need to do something to deal with the
asylum policy, which is the underlying problem, but in the
meantime, we need more time.
I guess my question to you is, I am wondering why CDC all
of a sudden has decided that pandemic conditions have improved
enough to terminate 42 when HHS is also asking us for billions
of dollars--and I think we are about to vote on a $10-billion
package of emergency funding to address the pandemic--and you
continue to extend the COVID-19 public health emergency, most
recently in January, and I assume you will do it again in
April?
So you may have been asked this already today. I am sure
you have; it is a big concern along the border and for all of
us who live in States that are affected by what happens on the
border, including the drugs that come across.
Any thoughts on that, Mr. Secretary?
Secretary Becerra. Plenty of thoughts, Senator. Thanks for
the chance to try to clarify. Title 42 is authority that we
have under law to address a health-care emergency that relates
to the need to quarantine--the ability for us to take measures
which otherwise would not be lawful--to try to keep Americans
safe. That quarantine authority has been used very rarely, and
it is for the purposes of something like this pandemic that we
have suffered.
The public health emergency authority that I have to
declare a public health emergency throughout the country
applies different law in different ways with different
standards. And so that is why you see a different treatment of
title 42 and the public health emergency. What you talked about
on the border is one of the conditions that was reviewed for
purposes of title 42. But title 42 is not an immigration-
related law. It is a health care-related law.
When the science and the evidence tell us that we no longer
need the use of quarantine authority under title 42 because of
health-care conditions, then title 42 must come down. That is
why you see the actions being taken by the administration.
The evidence, based on the science, is telling us where to
go on title 42. The public health emergency takes into account
many other things beyond quarantining necessity and
authorities. And that is why you see a difference.
I will close by simply saying this. Using title 42 for
immigration purposes is a misapplication of the law. The
President, on his first day in office, sent to Congress a
proposal to fix our broken immigration system. That is where we
need to go if we want to deal with the border situation that we
have, not using a health care-
related authority to try to deal with immigration challenges.
The Chairman. The time of the gentleman has expired.
Senator Brown is next.
Senator Brown. Thank you, Mr. Chairman.
Mr. Secretary, it is nice to see you. Thirty years in this
city, so congratulations. Thanks for the work you are doing.
Just a few things I would like to mention in your work of
lowering drug costs, addressing pharmacy fees, CMS's
announcement just yesterday that it will be covering up to
eight at-home COVID tests for Medicare beneficiaries. Thank you
for all of those things.
There is a lot to like in your budget. I would like to pick
one thing that I know you agree on. You were helpful in this in
the House when you were there.
Some time ago, 25 years ago I think--yes, 25 years ago--
Akron Children's Hospital came to the House and asked that we
begin something called Children's Hospital GME, because they
did not have the dollars through Medicare reimbursement to fund
children's hospitals the way that we should. It is clearly the
best way to ensure the future of our pediatric provider
workforce. It is the single best way to train pediatricians.
You know that from your family. You know that from your work.
The President's budget proposes $350 million for CHGME, a
slight decrease in funding. We had included $375 million in the
omnibus just passed recently. Will you work with me and Senator
Casey on this committee--who has been a real leader--and other
champions here in Congress to make sure we go in the right
direction, not the wrong direction, in CHGME funding?
Secretary Becerra. Absolutely, Senator. And remember that
those numbers that we put out in the budget were what we
thought we would have, based on the CR. And so we had to be
realistic about where we could go, and the CR was way below
what the Omnibus is. So do not take those numbers so literally,
because they were based on what we knew at the time of the
budget being prepared, not what ended up happening with the
Omnibus.
Senator Brown. Thank you. And we will count on that. I know
your history, and I know your heart on this.
Cincinnati is home to two CDC NIOSH facilities--National
Institute of Occupational Safety and Health--where 550 Federal
employees conduct cutting-edge research. It is not nearly as
well-known as it should be. It is really an institution--there
is no facility in the world like this NIOSH facility, where we
really do learn so much through the collection of data and
study about occupational work injuries, and occupational work
illnesses. And it really is something I am particularly proud
of in my State.
HHS several years ago set aside $110 million to consolidate
and upgrade the current NIOSH facilities into one building, or
one set of buildings, bordering the University of Cincinnati
campus. Unfortunately, the Trump administration sidetracked it,
or worse, and we need to make sure that we move forward on this
facility, which is state-of-the-art by any measure.
Share any update on this project today, if you would, to
reassure the NIOSH workforce and the city of Cincinnati, and
workers around the country, that this is going forward?
Secretary Becerra. Senator, we are committed to it, because
there is no way that OSHA can do its work if NIOSH is not
operating properly. And NIOSH has a great responsibility to
make sure we are getting real evidence, real data to OSHA so we
can make sure that we are protecting workers against the
occupational hazards that we know exist throughout the
workplaces in America.
So we are very committed to it.
Senator Brown. Good.
Two other statements. One, I would like you to come visit
Cincinnati at some point during this so you can see NIOSH in
person.
Secretary Becerra. I appreciate that.
Senator Brown. And second, the President recently put out
an executive order in support of the use of project labor
agreements for large-scale construction projects like the
Cincinnati project. It is my expectation that HHS, or CDC as
its proxy, will support the use of a project labor agreement
for the construction of this new facility. My staff will be
working with your office, with folks at CDC. I am looking
forward to making sure this project, which is about workers,
centers workers in its construction, in what we need to do.
Secretary Becerra. I'm with you all the way.
Senator Brown. Thank you, Mr. Chairman.
Thank you, Mr. Secretary; good to see you.
The Chairman. Thank you, Senator Brown. As always, sticking
up for the consumer. Thank you.
Next is Senator Bennet.
Senator Bennet. Thank you, Mr. Chairman. Can you hear me?
The Chairman. Yes.
Senator Bennet. Okay; I really appreciate it. Secretary
Becerra, I want to thank you for joining us this morning, and
it was great to see you in Denver a few weeks ago discussing
the important topic of youth mental health, which I know is of
great concern to both of us. I deeply appreciate your attention
to that.
And as you know--and I know you know--rising costs are a
concern for many Coloradans and people across the country. We
have a real opportunity to do something this year on
prescription drugs.
I believe very strongly that we should work to cap insulin
at $35 a month. At the very least, we need to make sure we are
not increasing costs at this time, which is why we need to
extend the advance premium tax credits that were expanded under
the American Rescue Plan.
In Colorado, 75 percent of people on the exchange are
receiving financial help to make health insurance premiums more
affordable this year as a result of these expanded credits. And
if we do not extend them, Coloradans could lose $74 million in
support for premiums for 2023.
I have seen Congress do everything they can to extend tax
cuts for the wealthiest people in the country, and for the
largest businesses. It seems to me that the least we could do
is extend this support for middle- and low-income Americans.
Secretary Becerra, could you highlight how important it is
for Congress to extend these premium tax credits as soon as
possible?
Secretary Becerra. Senator, as you know, there is a cliff
that exists for those in the middle class to be able to afford
health insurance coverage for their families. There is nothing
like having a good quality health insurance plan to give you
peace of mind, to know that if you ever need it, your child can
go to the hospital when necessary, and you will not go bankrupt
as a result.
Extending these tax credits is indispensable in continuing
the progress in getting more and more Americans covered. We saw
an additional 20 million Americans get health insurance
coverage under President Biden's plans, and we want to continue
that progress. Because, as I said, there is nothing like having
the peace of mind knowing that you can take your child or loved
one to the hospital when necessary.
Senator Bennet. And can you connect that to the tax credit
extension?
Secretary Becerra. Without the tax credit, many of these
families, middle-class families that received affordable
insurance coverage under the Affordable Care Act, would not be
able to hold it. It would be too expensive. And it could be
something as simple as getting a small raise in your salary
from one month to the next, and that puts you over the top of
what allows you to quality for a tax credit. That is insane.
That is the cliff that people fall over.
Senator Bennet. That is truly insane. And by the way, if
you want to inspire people to work, you have to do away with
these kinds of cliffs.
Just in the last couple of minutes I have left, Mr.
Secretary--we spend a significant amount of time on mental and
behavioral health in this committee, and I am glad that the
budget reflects the importance of addressing this issue as a
crisis.
The budget includes a number of proposals we are
considering, including improving Medicaid, which would help the
poorest and most vulnerable children and youth in this country.
Could you talk a little bit about why we need to make
strategic investments to address this mental and behavioral
health crisis for young people in this country?
Secretary Becerra. Senator, today, if you were to talk to
families across the Nation about mental health, about half of
those who are parents would tell you that their children--they
have had to think about taking their child in to get mental
health services. About half. We have seen the numbers skyrocket
for ER, emergency room visits by young adults and adolescents,
especially among girls. It is a crisis, and we know it is
somewhat under the table, but it is a crisis. And we need to
start acting now. That is why the President makes substantial
investments in this.
I will tell you that the more help we have in making sure
that we launch well the 988 national hotline number that will
be used to help those who call, whether it is because of
suicide or other mental stress--anyone who is thinking about
committing suicide who takes the time to make a call and
reaches out for help should not receive a busy signal or be put
on hold. 988 will launch in mid-July. We are putting together
this network of detached providers who are out there right now
in the country. We want to make it into one holistic approach.
988 should become the equivalent of 911 for mental health.
Senator Bennet. I agree with that, Mr. Secretary, and I
will also say that, in Colorado, we are having a mental health
crisis among our young people, our adolescents, that is unlike
anything that we have faced before. Part of that is COVID, but
it is lots of other forces that are tearing at our young people
as well, and especially in rural places where there really is
no access to services. This has become a huge, chronic problem.
Mr. Secretary, thank you.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Bennet.
Senator Daines is next.
Senator Daines. Mr. Chairman, thank you. Mr. Secretary,
thank you for coming up here today.
For 50 years, title X family planning funding has been
managed successfully by the State of Montana's health
department. In fact, last year Montana passed a law that
prioritizes awarding these funds to comprehensive health-care
providers like community health centers, rather than abortion
centers like Planned Parenthood. Last week, your Department
pulled more than $2 million in funds from the State of Montana
and awarded it instead to a pro-abortion nonprofit that has
pledged to funnel these funds to Planned Parenthood. This
loophole does an end-run around Montana State law. It violates
the Federal title X law itself, which says that funds cannot be
used as support for projects where abortion is a method of
family planning.
This is not the first time that you have abused taxpayer
dollars to get around State laws, since last year you also
deployed title X funds to try and counter Texas's life-saving
Heartbeat Act. You have told this committee repeatedly you
would follow the law. What we have seen here in these two
examples is, that is not the case.
Mr. Secretary, why should Congress give you a 40-percent
increase in title X funds that you have requested when you are
abusing these funds to get around my State's and other States'
pro-life laws, contrary to Federal law and the will of
Montanans who do not want to subsidize the abortion industry
with their tax dollars?
Secretary Becerra. Senator, first let me thank you for the
way you posed the question, because I know that we all have
some very deeply held beliefs when it comes to the issue of
abortion. But our beliefs are not the law. We must be guided by
the law.
And as I said when I was first here for confirmation, we
will not only follow the law but we will make sure we enforce
the law.
Senator Daines. Have you reviewed, has your team reviewed
the Montana State law that is very clear on this issue, that
prioritized--for these exact reasons--that the feds would not
come in and pull $2 million, basically usurping the laws of
Montana because of a certain agenda that you are driving here
relating to abortion?
Secretary Becerra. Senator, with due respect, it is not an
``agenda.'' It is the law that we have to follow----
Senator Daines. Have you looked at the Montana law? We just
passed this law, and you have circumvented the law and pulled
$2 million and reallocated it against the will of the people of
Montana and the laws of Montana.
Secretary Becerra. Senator, as a Federal department, we
must abide by Federal law. That is what we are doing when it
comes to our family planning program money. And we will
continue to abide by the law. We respect what a State may wish
to do in deploying some of its resources, but we have an
obligation to follow Federal law.
Senator Daines. Well, we will look forward to further
discussions on this, as you have gone around the laws of
Montana, literally dollars allocated and then pulled back.
I want to talk about title 42 for a moment. In Montana, we
are a northern border State, so you are probably wondering, why
is a northern border State raising the question of what is
going on in the southern border? Well, it is because we are a
northern border State with a southern border crisis.
Our communities in Montana have been devastated by the
inflow of drugs, particularly Mexican cartel meth, and now
fentanyl, as well as heroin. And what is happening is that our
Border Patrol agents are overwhelmed by the flood of illegals
coming across our southern border. It is a zero sum game. It is
a zero sum battle, because the resources are being used to
apprehend the illegals coming across, and they cannot spend the
time needed here to stop the drugs that are flooding across the
southern border by these Mexican cartels.
With this drug crisis that we see in Montana, there comes
as well a massive increase in violent crime, nearly all of
which, if you speak with law enforcement on the ground, is tied
directly to the drugs flowing across the southern border.
Now, instead of being tough on the border, this
administration has taken an outrageous step of ending title 42
removals. There was a border sheriff, a southern border
sheriff, here last week who says we have a crisis on our hands
today. Removing these title 42 provisions turns it into a
disaster. It has been widely reported that the DHS is making
preparations for as many as 18,000 illegal immigrants per day.
Mr. Secretary, given the CDC's role in this decision, can
you discuss the extent to which you consider the potential
impact rescinding title 42 would have on illegal immigration?
Secretary Becerra. Senator, thank you for the question. And
if we focus on what title 42 is, it is an authority that is
granted under statute to deal with health conditions in the
country, usually for purposes of quarantining.
What CDC had to do in implementing title 42 is determine
whether or not, based on the health conditions in the country,
we could take measures which otherwise would not be allowed by
law to try to isolate or quarantine individuals. That is the
purpose of title 42.
CDC has considered current public health conditions and
recent developments within the COVID-19 pandemic and made the
decision based on health considerations. What you have spoken
to--and you raised some really important considerations when it
comes to immigration law and also our border enforcement--those
are not necessarily public health-related conditions.
On President Biden's first day in office, he sent to
Congress a proposal to reform a very broken immigration system.
But we cannot use a health-care law----
Senator Daines. And President Biden rescinded the Remain in
Mexico policy when he was sworn in as well, which has been a
direct contributor to the flood of illegals we are seeing on
the southern border.
So, I am out of time. Thank you, Mr. Chairman.
The Chairman. I thank my colleague. And since there was a
question about title X, I just want to make sure everybody who
is following this understands that under Federal law, title X
can be used for contraception and for family planning. That is
under Federal law what it can be used for, and we are going to
put into the record some further analysis of that.
[The analysis appears in the appendix beginning on p. 120.]
The Chairman. Let's see. Next will be Senator Lankford.
Senator Lankford. Mr. Chairman, thank you. Mr. Secretary,
thanks for being here. This is a long day for you already. We
have been popping in and out heading to votes. You have been
trapped in the chair for a while going through this, so I
appreciate your engagement.
Let me do the unusual thing between the two of us, and give
you some compliments at the beginning. Can I do that?
Secretary Becerra. Absolutely.
Senator Lankford. Your team at CMS and their work on DIR
fees is something that--I have pushed for a long time on this.
I am pleased to be able to see the work going on with CMS in
the DIR fees. That is a very big issue, especially for rural
pharmacies continuing to be able to do the work. There are a
lot of people who are counting on access to rural pharmacies
and other pharmacies based on that work. Just don't allow
entities out there to be able to water everything down with
what actually needs to be done. Keep going all the way through.
The second thing I would say to you is, you and I had a
banter back and forth about ``birthing persons'' last year in
your budget. Your budget does not use the term ``birthing
persons'' this year; you use the term ``mothers.'' Thank you.
You have ``pregnant people'' in there as well. That is close
enough on it. So I appreciate just the terminology on being
able to use that as well.
Let me talk to you about a couple of things on this that I
do want to be able to get in on. Switching over, the questions
for the record and the responses from your team have been
exceptionally slow, or nonresponsive entirely. I am not trying
to be difficult in some of the questions, but when you were
before us last summer it took all the way until February to be
able to get an answer, and when we got the answers, they were
non-answers. When we have asked some other questions to be able
to follow up earlier this January, we got a non-answer back in
March. We've got to be able to get dialogue.
So even if you and I just get time on the phone to be able
to get answers, we have to be able to work through answers and
try to be able to figure this out. You have been in the House
of Representatives. You know what that is like. You want to
actually get answers and try to figure out which direction the
administration is going.
So my first question is really just, can we find a process
where we can actually get answers to questions?
Secretary Becerra. Senator, I hope I can give you an answer
that says you are going to get what you need. And why don't we
do this? I will make sure I give you my cell number before this
hearing is over so you can call me directly.
But we have gotten questions where we have had binders full
to answer. It is tough when you get over 400 questions asked,
more than 500 different briefings that you have to provide. But
having served as a member, sitting where you are, absolutely we
want to be responsive.
Senator Lankford. I will be judicious with that, but let's
find a way to be able to just get answers to questions. We are
looking for directional issues.
Following up on what Senator Daines was talking about with
title 42, this has been used as an immigration policy piece.
For instance, the administration came in and changed title 42
and said if you are coming in with a young child, then title 42
does not apply to you anymore. There is no more pandemic for
you. So there are some things that have actually worked it as
an immigration policy.
I think our biggest issue is that at the same time, there
is a request from the administration saying we need 10 billion
more dollars because of the pandemic. There is also a decision
to say the pandemic is over and the risk is over at the border.
And there is not even a requirement for individuals crossing
the border to get a vaccine when they cross. It is made
available to them, but is not a requirement to be able to do
that.
I think that is the biggest issue that we are seeing from
everybody.
Secretary Becerra. And I won't try to give you a full
response, but I will simply say that with regard to children,
the reason there was an exception made to children--and by the
way, that has been questioned by some courts--is because if a
child is not allowed to come in, we have no idea what will end
up happening to that child.
Senator Lankford. Right. These are even family units,
though, coming with small children. So it wasn't just a child
who was an unaccompanied minor. These were family units of any
size, that if they had a 4-year-old with them, then they were
all allowed to come in. And again, we can follow up on that. I
have 10,000 questions I want to go through.
One of the entities in my State had done testing for at-
home antigen COVID tests, which they had great responses from
in their labs, and they had a really positive piece. I want to
fill you in on what happened on the FDA side on this, though,
and the frustration that they have had.
They had a very difficult time hearing back from the
reviewers. The lead reviewer that they had went on leave for a
while, and no one else was assigned to their case, so they had
an extended period of time where they got no responses at all.
When they started getting responses back, they were asked
to send information in by email, but the email servers kicked
it back and said it was too large. And there was no way to
actually be able to submit it online as well, to be able to do
it.
When they finally did get an answer just this past week,
after all this long process they had gone through for months,
this was the answer they got back: ``FDA has determined that
further review of your EUA request is not a priority. FDA
therefore declines to issue an EUA for the product at this
time.''
Here is the concern. The sense is for these at-home antigen
tests that are coming out dealing with COVID, that it seems to
be that the larger companies are getting through the process,
and the smaller companies are getting the response ``this
request is not a priority at this time.''
Tell me that is not so. And how are we able to document
that the larger companies are not navigating the system, and
the smaller companies are getting from FDA ``you're not a
priority''?
Secretary Becerra. Senator, thanks for the question. Let me
first say that if you wish, we could try to follow up on that
particular company and find out where things went.
But what I will tell you is, when you are dealing with
volume in the tens of millions, we do look for those
manufacturers that can produce quickly, because those tests are
needed now. And so we do try to reach out to those who can give
us the volume that we need.
Senator Lankford. But then again, the manufacturer is not
necessarily the company that actually created it. So that
becomes the challenge here: if you have a really good product,
wherever it is coming from, how do you turn that around? If you
get a hundred smaller units that are able to accomplish it,
that may be the same as getting one larger one. So we are
getting back to the biggest companies getting the preference
and smaller companies that may have a good product hearing
``you're just not a priority.''
Secretary Becerra. We will work with you on that, because
we want any--especially a domestic manufacturer or provider, to
be able to get that out.
Senator Lankford. I will have several questions for the
record that I will follow up on, and I will be judicious on how
many we give you. I understand you have gotten several, but
there are some issues on gender dysphoria and other issues that
are coming up. And decisions are being made, and we want to
know how they are being made and what the science behind it is
and how you are tracking it.
Secretary Becerra. I look forward to getting them.
[The questions appear in the appendix.]
Senator Lankford. Thank you.
Secretary Becerra. Thank you.
The Chairman. I thank my colleague. Senator Casey is next
online, and then Senator Hassan, who is here, and we just urge
colleagues who have not checked in either online or in person,
we are getting ready to wrap up.
All right; Senator Casey?
Senator Casey. Thank you, Mr. Chairman.
Mr. Secretary, great to be with you again. Let me start by
commending you for your public service and the work you do
every day, and your team does. It is hard, hard work you are
doing in a very, very difficult political environment, and I
appreciate the work you do and the services you provide to help
people across the country.
I wanted to start with long-term care, and I do want to ask
one question, a very specific question about children. But
long-term care, of course, is a worry for so many families, so
many tens of millions of families who worry about this. I know
from your own life's story your family has wrestled with it as
well. And I know how seriously you focus on this issue. And we
know that all of the long-term care challenges that we had
before are a hell of a lot worse because of the pandemic, just
like everything else is worse.
We've got to ensure access to quality long-term care. And
as you note in your testimony, the administration has been
focused on several aspects of long-term care, including home
and community-based services for seniors and people with
disabilities.
We got a good start with this in the American Rescue Plan.
We got a foot in the door: $12.7 billion to expand these
services. It's never been done before like this, by the way,
and the American Rescue Plan made that possible. But $12.7
billion is nowhere near what we need.
To make the investment, to give Americans what they are
asking for every day of the week, with a waiting list of almost
a million people, we've got to pass legislation. I have the
bill, the Better Care Better Jobs Act, and we are going to do
everything we can to make sure that this bill passes, or that a
policy is enacted into law that incorporates the bill.
This is obviously better care for seniors and people with
disabilities in the place they want the care, either in their
home or in the community. It is also, of course, better jobs
and better pay for the workers. We cannot have the best
caregiving in the world if we are paying workers 12 bucks an
hour, and that is the reality in America today.
In addition to the home and community-based services, I
have been working with Senator Toomey on legislation that
focuses on the Special Focus Facility program, where we have
tried to shed light on cases of abuse and neglect in the small
number of under-performing nursing homes. We have legislation
to do that. I saw that the administration has a 24-percent
increase in funding for oversight of nursing homes.
So that is my question. How will these appropriations, or
increases in appropriations, toward nursing home quality and
oversight be beneficial to better protect residents?
Secretary Becerra. Senator, by the way, thanks for your
longstanding work on these issues. And what I will tell you, as
you know, is that there are a lot of these service providers--
these facilities are doing their darnedest, and COVID made life
even more difficult for them, and it is tough. But it is tough
to find the professionals that you need who are qualified. It
is tough to pay them properly. All of those things add up.
And then, of course, you have those that do not try to
provide that service with quality, and that are cutting
corners. And that is where we are going to do much more in
oversight and surveillance. The budget, as you said, reflects
that with the more than 20-
percent increase in funding to make sure we do that. And we are
also trying to provide more services and resources so that we
can actually help increase the pay of those workers who do
indispensable work with our loved ones.
And so, we look forward to working with you, whether it
means moving more of the services towards community-based,
home-based services, or to make sure if you are going to go to
a nursing home or some facility that may not be so close to
home, that you are going to receive quality services for your
loved one.
Senator Casey. Thank you, Mr. Secretary.
I wanted to ask you a question about what the
administration is doing to track and support children who have
lost a caregiver, and how we can better support family members
in this circumstance.
We have 200,000 kids in the United States who have lost a
parent or a primary caregiver due to COVID-19. Research shows
that unaddressed childhood grief and trauma can lead to
difficulties like decreased academic performance, mental health
issues, and early mortality.
So, what can you tell us about the administration's efforts
in this area?
Secretary Becerra. Senator, it is a tragic story. As you
know, tens of thousands of children in America have lost their
primary or secondary caregiver as a result of COVID. What we
are trying to do is make sure that we provide services to
families, whether it is that home or community-based service
that makes it possible for the child to receive at-home
services with quality. We are also trying to beef up the
support we provide to those kids who have to go through the
foster care program, because we know there, we find a lot of
kids are falling through the cracks.
We are going to make an emphasis as well on those kids who
are aging out of the foster care system to make sure that there
are continued resources even after they have to leave the
foster care program and be on their own.
And so we are going to continue to make investments. This
particular budget, as we have discussed over the course of this
hearing--the investments in mental health services, substance
abuse services--all of that is focused to make sure we get
people back on the right track.
Senator Casey. Mr. Secretary, thank you.
Mr. Chairman, thank you.
The Chairman. Thank you, Senator Casey.
Senator Hassan?
Senator Hassan. Well, thank you, Mr. Chairman and Ranking
Member Crapo. And, Mr. Secretary, thank you. Yes, you have been
here for a good couple of hours now, so thank you for your
patience and your service.
I want to start with a question about medication-assisted
treatment. Health-care providers in New Hampshire and experts
before this committee have made clear that medication-assisted
treatment is critical for individuals with opioid use
disorders. With medication-assisted treatment, more people can
enter and remain in recovery.
What is the Department of Health and Human Services doing
to expand access to medication-assisted treatment?
Secretary Becerra. Well, we've been working with our
partners in the Drug Enforcement Administration and the
Department of Justice to make sure that we can move forward,
because we have seen that the data proves it. The science and
the evidence show that medication-assisted treatment works. And
so we want to make sure that we give providers the flexibility
to offer that treatment to a lot of folks who will benefit from
it.
So we are going to be driven by the science and the
evidence, working with you--and thank you for all the work you
have done on this--to make it possible for folks to recover.
Senator Hassan. Well, that is good to hear. There were
obviously restrictions lifted and some flexibilities granted
during the pandemic, and it sounds like you are going to
continue to work with the DEA and States to make sure that we
could perhaps make some of those permanent, again based on
data.
Secretary Becerra. Absolutely.
Senator Hassan. Thank you.
As drug prices soar, Granite Staters are rationing
lifesaving medications because they cannot afford them,
choosing between filling their prescriptions and putting food
on the table. One of my constituents stopped taking her blood
pressure medication for periods of time and suffered a stroke,
and is now in long-term care, something she was hoping to avoid
as she aged.
Congress has to take immediate action to cut drug prices.
How would allowing Medicare to negotiate drug prices save money
for patients and reduce Federal spending?
Secretary Becerra. Well, Senator, as you just pointed out
with one of your constituents not taking medication as needed,
that is so common. One in three Americans have reported to us
that they do not take the medication they are supposed to
because they cannot afford to continue to use it up as quickly
as they would. And so, we have to do something.
We are ready to use whatever authorities we have. We do not
believe we have the kind of authority that will not send us to
court to be able to do as good a job as you all could do to
change some of the law to give us more authorities. But if we
were able to, for example, negotiate the price of drugs the way
you negotiate the price of a car, the way you negotiate the
price of that mechanic bill--there is no reason why when
something is as important and precious as a medical service or
a prescription drug, you cannot get the best price for your
patient or your loved one.
Give us that opportunity through Medicare, and we will
lower the price of prescription drug medication for Americans.
Senator Hassan. Well, I hope we can find bipartisan support
to do just that. Thank you for your commitment to lowering the
cost for prescription drugs.
I want to move on to the issue of title X. State laws
restricting women's capacity to make their own health-care
decisions and, frankly, chart their own destiny, are forcing
some family planning centers to close and others to serve
entire regions using very limited resources.
New Hampshire's State Government's recent decisions to
reject federally funded contracts to some family planning
centers is going to make it harder for centers to serve their
patients. How have State anti-choice restrictions influenced
the budget requests for family planning funds?
Secretary Becerra. Senator, first and foremost, we must
enforce and comply with Federal law. And under Federal law,
family planning services should be available to families who
qualify. We are going to make sure that we provide that
service, including contraception services, to families
throughout the country.
We respect what States wish to do in terms of how they
implement their particular laws and their enforcement and
administration of their services, but we have an obligation to
make sure that under our laws, our Federal laws, no one is
discriminating. So we are going to make family planning
services available to everyone who qualifies under Federal law.
Senator Hassan. Well, I thank you for that commitment. That
is why I am working to increase title X funding in the Fiscal
Year 2023 Appropriations bill. I look forward to working with
you to make sure that that happens so that we can support these
critical services for women in New Hampshire and all across the
country.
A quick question about child care and Head Start. The
Office of Head Start and the Office of Child Care operate two
very different but equally important programs to support early
learning. Combined, these two offices help more than 2 million
children access affordable child care across the country each
year.
How will HHS most effectively use the current proposed
budget increase to ensure that these two agencies work
collaboratively to serve as many families as possible?
Secretary Becerra. Senator, one thing I can tell you is
that we wish to have those services be as seamless as possible.
So, whether it is Early Head Start program, or whether it is
just child care for the infant and toddler, we want to make
sure that throughout that process, a family knows that their
child will get the best care and educational services possible.
So we are going to try to be as coordinated as we can to
make that as seamless a process as possible.
Senator Hassan. Well, I appreciate that very much.
Thank you, Mr. Chair.
The Chairman. Thank you, Senator Hassan.
Senator Warren?
Senator Warren. Thank you, Mr. Chairman.
So, President Biden has created a record 7.9 million jobs.
There were more jobs created in the first 14 months than of any
presidency ever. But even as we are trying to get our economy
and our lives back to normal, families are getting hit by
rising prices on essential goods from gas to groceries. And, as
Americans are looking to get out and about again, to go back to
restaurants and bars and gyms and movie theaters, those
businesses are struggling to find enough workers to meet the
surging demand.
So now economists are warning that inflation could spread
from goods to services, especially if we do not get more
workers into the labor force. But one of the big things that is
holding back the labor force participation is a shortage of
affordable child care.
Secretary Becerra, when parents cannot find affordable
child care, how does that affect parents' ability to work, and
in turn, businesses' ability to hire?
Secretary Becerra. It brings things to a halt. It grinds to
a halt, and you are stopping productive Americans from getting
out there and helping businesses be profitable and prosper. It
makes it very difficult for our economy to continue to be the
leader when you cannot get people who are qualified to get out
there and work.
Senator Warren. Well, you know, you make a good point here.
The American economy relies on working parents. And the parents
rely on child care to be able to go to work. But even with
record job creation across the economy last year, the child-
care industry is still down 136,000 workers compared to early
2020.
So, Secretary Becerra, there is clearly strong demand for
child care. Why isn't supply rising to meet it? Why hasn't the
market solved this problem?
Secretary Becerra. Well, if it is left in the private
sector's hands, it becomes unaffordable for most families,
including middle-class families. You are paying essentially
college tuition to care for your 2-year-old child. At the same
time States, with the support of the Federal Government, have
been providing subsidies to help child-care providers get out
there and offer those services.
Here is the difficulty: as you mentioned, some of the
workforce is getting paid the lowest wages. They need to
increase that, because those folks are now saying, ``I do not
have to do this job. I can go make more money flipping
burgers.'' We have to increase the wages that we pay to people
who are essentially caring for the next generation of leaders,
and at the same time we have to be able to expand the size of
the care facilities so that they can take in more kids from
these families.
And so, the proposal in Build Back Better actually made
some of that possible. I hope that we are able to succeed in
getting some of that across.
Senator Warren. So let's just unpack that, though, a little
bit in what you are talking about here. Child-care providers
are operating on razor-thin margins. They just simply do not
have money to pay their workers more than those workers could
make right now by just moving over to McDonald's, or to the gas
station down the street.
That means the child-care center cannot hire staff, and
that means that our economy does not have the child-care slots
that it needs for parents to be able to get back to work, and
for our economy to get back to normal.
So let me just ask. I think you have already referred to
this, but let me put the question to you directly: do you agree
that to fix this problem, Federal investments in child care are
essential, not just for tackling higher costs for families with
young children, but also for reducing the drivers that are
raising costs economy-wide?
Secretary Becerra. Without a doubt. Just for the same
reason we have public education in this country, we realize
that if we left it in private hands, very few parents would be
able to afford to send their kids to K through 12. The same
thing applies to child care.
We need to be supportive, because there are caregivers who
are trying to do the best job they can, but they are
overwhelmed.
Senator Warren. In other words, whether we have children
individually or not, we all have an interest in making this
economy work. And child care is part of making this economy
work. Is that fair?
Secretary Becerra. It takes a village.
Senator Warren. Well, thank you very much. This is a
critical moment in our economic recovery, and we need to make
these investments in child care in order to keep our economy on
track and to fight back against inflation.
Investments in child care will help lower costs for working
families, and will help boost our economic recovery by ensuring
that parents can go to work, preventing a labor shortage, and
preventing further inflation.
These investments just cannot wait. American families
cannot wait. Our economy cannot wait. So I hope we can get this
done and get it done soon.
Thank you very much for your work on this, Mr. Secretary.
Secretary Becerra. Thank you.
The Chairman. Thank you, Senator Warren.
Mr. Secretary, you have been very patient. We appreciate
it. There is just one issue left that is really important to
Oregonians, and I have to ask about it. That is this question
of the pharmacy benefit managers squeezing these pharmacies.
And we have seen it all across Oregon.
As you know, Oregon is not alone. This is happening
everywhere. And essentially you have these small pharmacies,
like the one I visited recently in southern Oregon, that have
the PBMs and the insurance companies come in long after the
sale has been made--in one instance, I was told about a year
after the sale was made. And it is almost like the PBM says,
``Gee, we are not making enough money this year. We are just
going to come back and tell the pharmacist they have to send us
another big chunk of money.''
And the idea that in America, after you have purchased
something, in effect you have a point of sale--you are an
Attorney General; that is just kind of basic consumer
protection law. You are not allowed to just come back months
and months, and in this case, a year later--and this rise of
what have euphemistically been called direct and indirect
remuneration, or, quote, ``DIR'' fees, just strikes me as an
absolute rip-off. And I see the pharmacists not being able to
make these payments, which hurts the consumers, particularly in
underserved areas, and you have this spiral that leads, as I
have seen over the last few months, to folks just waiting in
line because the existing pharmacies suddenly have all these
new people who will deluge the facilities that remain.
And our CMS Director Chiquita Brooks-LaSure, in my view, is
really doing good work in terms of trying to get some
protection for folks, and to get a point-of-sale rule so that
these PBMs could not come back and just indefinitely squeeze
the small pharmacy. And I would just not be accountable to my
constituents where this issue is front and center, particularly
in rural communities--our State legislature is focused on it--I
would not be accountable to my constituents if I did not ask
you where we stand on this, and I want you to know that your
CMS Director has been very responsive to my questions.
I just would like, before we wrap up, to get a sense of
where we are with things.
Secretary Becerra. Mr. Chairman, probably the best thing I
can tell you is to stay in touch with Administrator Brooks-
LaSure, because we are trying to move as quickly as we can on
this.
Everywhere I go--and I have gone to a lot of community
health centers, a lot of places dealing with vaccines and so
forth. Everywhere I go, I always get tapped on the shoulder by
someone who says, ``Can we really deal with this? Because it is
making it not only impossible for us as a provider, a pharmacy,
to dispense, but it makes it tough for us to help those
families who need those prescriptions right away.''
And so, we want to tackle this, but as you know, this is an
issue that has been around festering for years. I think CMS is
going to try to move as quickly as we can. I suspect we are
going to find ourselves in court at some point or another, but
we are going to move, because it is too important to make sure
we dispense these medications that people absolutely need.
The Chairman. There is unquestionably a powerful lobby out
there for business as usual. And I just want to raise--I have
been visiting a little bit with my friend and colleague Senator
Crapo, because we have lots of these small pharmacies.
The PBMs clearly had a role 30 years ago when people did
not have all the data that is out there now about pricing, and
there weren't people who could use it all. But somehow the PBMs
just seem unwilling to change. They just want to do business as
usual along the lines of what I described in Oregon and what
you have people, in your words, tapping you on the shoulder
about when you show up, for example, in a small town in Ohio or
West Virginia or Montana, where people all have these kinds of
concerns.
So I just thought it was fitting that we wrap up with that.
We thank you very much for your taking the time to bring us up
to date on the administration's priorities. And I just wanted
to wrap up with an issue that really has a human face in
communities all across the country. And I can see that you are
very much aware of that, and we look forward to working with
you on this issue and others.
Questions for the record are due to the committee on April
12th at 5 p.m. I also want to thank my colleague, Senator
Crapo, for his assistance, especially this morning, but on so
many things. And you could probably tell, as you take off, Mr.
Secretary, how committed the members here on both sides of the
aisle are with respect to the mental health issue, which we
will also be working closely with you on.
With that, the committee is adjourned.
[Whereupon, at 12:35 p.m., the hearing was concluded.]
A P P E N D I X
Additional Material Submitted for the Record
----------
Prepared Statement of Hon. Xavier Becerra, Secretary,
Department of Health and Human Services
Chairman Wyden, Ranking Member Crapo, 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 health-care 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's
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, over 215 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 health-care 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 health-care 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 988 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 FY 2023. The FY 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 a historic mandatory funding request to transform
our ability to protect the Nation from future pandemics and other
biological threats. 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 and treatments reimbursement, with the same soon to
follow for vaccinations. 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 FY 2023 budget builds on Congress's 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 and
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 in
program-level resources for the Agency for Healthcare Research and
Quality (AHRQ) to support evidence-based research, data, and tools to
make health care 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 health-care 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 health care 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 health-care 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 health-care costs for most consumers and
increased enrollment to record levels. In fact, consumers saw their
average monthly premium fall by 23% 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 health-care 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 health-care
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 FY 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. Longstanding, 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 FY 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 health care 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 health care 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 health care, 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 and 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 health-care 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 health
care, 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 health care,
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 FY 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 FY
2022 enacted will support direct health-care 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 FY 2023.
To address chronic underinvestment in IHS, the budget increases
funding for each year over 10 years, building to $36.7 billion in FY
2032. This increase of 296 percent over the 10-year budget window
accomplishes funding growth beyond what can be accomplished through
discretionary spending. Over a 5-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 longstanding
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 health care 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 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
health-care 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 health care 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 health care, to
ensure that families and communities affected by mental illness receive
the highest-quality care and supports.
The budget improves Medicare coverage of mental health care 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
health-care 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 FY 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 health-care 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 FY
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 of 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 health-care 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's 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 health-care fraud, yielding a return on
investment of $13.6 billion over 10 years. The pandemic has unleashed
new health-care 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 FY 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.
______
Questions Submitted for the Record to Hon. Xavier Becerra
Questions Submitted by Hon. Ron Wyden
organ procurement organization reform
Question. HHS has taken important initial steps to reform the U.S.
transplant system. However, a legislative proposal summarized in the
President's 2023 budget appears contrary to reforms to establish and
enforce performance metrics for the Nation's 57 organ procurement
organizations, reforms that I have previously supported and urged
immediate implementation of.
Specifically, the budget proposes legislative changes to allow CMS
to ``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.''\1\ HHS's stated goal is to avoid organ procurement
disruptions; however, I am concerned it would undermine the
government's ability to hold underperforming Organ Procurement
Organizations (OPOs) accountable. Reform of the U.S. transplant system
has bipartisan support from this committee and particular relevance
amidst the COVID-19 pandemic, which causes kidney damage and is widely
expected to cause long-term organ failure in COVID-19 survivors.
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\1\ Health and Human Services FY 2023 Budget in Brief. Option 2,
pg. 84. See, https://www.hhs.gov/sites/default/files/fy-2023-budget-in-
brief.pdf.
It is imperative that the U.S. organ procurement and
transplantation system functions at its optimal level to prevent any
missed opportunity for organ donation, as no American should die while
waiting for a transplant. In July 2021, I along with other bipartisan
members of this committee, wrote to CMS to voice our concern with the
protracted timeline for enforcement and encouraged CMS to consider ways
to hold OPOs accountable during the interim. The budget proposal
allowing underperforming OPOs to be recertified goes in the wrong
direction on this issue. In light of these concerns, please address the
---------------------------------------------------------------------------
following:
If this legislative proposal is passed by Congress, how would HHS
and CMS intend to hold OPOs accountable during the interim period?
And, if OPOs that fail to meet these metrics are recertified, as
proposed, how will CMS measure improvement and ensure the improvement
is maintained through the certification cycle?
Please provide CMS's rationale for this proposed change.
Please provide any additional details that CMS has developed for
this proposal.
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.
On December 2, 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 for the OPOs
to achieve to be recertified in 2026. This rule was published with the
intention to increase 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 increasing competition for donation service
areas (DSAs) that were open to competition. At the end of the
recertification 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 recertification 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
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.
There are currently 58 OPOs that are responsible for identifying
eligible donors and recovering organs from deceased donors in the
United States (U.S.), with no current statutory authority to add new
OPOs. Thus, under current law, CMS cannot certify any new entities as
OPOs. This not only limits competition with existing OPOs but also
excludes from the competition other entities that might perform well as
an OPO if certified.
Additionally, if an OPO fails to meet the outcome measures set
forth in 42 CFR Sec. 486.318, it will be decertified, even if the OPO
has demonstrated significant quality improvement in their DSA during
the recertification cycle. An OPO taking over a decertified OPO's low
performing DSA may have a significant undertaking to increase their
performance to meet the Tier 1 top 25 percent benchmark to be
automatically recertified. An OPO may only have 1-2 years in a DSA they
took over from a low-performing OPO before being recertified. CMS
believes that having the explicit legal authority to apply discretion
to determine whether to recertify OPOs that have recently assumed
responsibility for servicing a previously low-performing DSA and are
making significant improvement would provide the flexibility it needs
to improve organ procurement in DSAs without disruption to organ
procurement.
hospital price transparency
Question. In September of 2021, Chairman Wyden sent a letter to
Centers for Medicare and Medicaid Administrator Brooks-LaSure regarding
the Calendar Year 2022 Medicare Hospital Outpatient Prospective Payment
System and Ambulatory Surgical Center Payment System Proposed Rule. The
letter encouraged the administration to finalize proposals to
strengthen the thoroughness, accessibility, and enforcement of hospital
price transparency regulations under 45 CFR part 180, originally issued
in the Calendar Year 2020 Hospital Price Transparency final rule. A
recent report indicates that many hospitals may not be fully compliant
with the requirements.\2\ I am requesting the following information
about compliance with this regulatory and statutory requirement.
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\2\ Semi-Annual Hospital Price Transparency Compliance Report,
February 2022, https://www.patientrightsadvocate.org/semi-annual-
compliance-report-2022.
How many hospitals to date have been issued a warning notice or
request for a corrective action plan for noncompliance with the price
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transparency requirements?
Of the hospitals identified to be noncompliant, how many have
subsequently come into compliance and how many have been issued a civil
monetary penalty?
What methods under 45 CFR part 180, subpart C is CMS utilizing to
monitor compliance with the rule and with what frequency is it engaging
these methods?
Answer. Increasing access to affordable health care is a top
priority for the Biden-Harris administration. That's why HHS is
committed to ensuring that consumers have the information they need to
make fully informed decisions regarding their health care.
Hospital price transparency helps people know what a hospital
charges for the items and services it provides. Under CMS regulations,
hospitals must post on their website a machine-readable file containing
a list of all standard charges for the items and services they provide,
as well as a consumer-friendly list of standard charges for at least
300 shoppable services. CMS expects hospitals to comply with these
requirements, and is enforcing them to ensure people know what a
hospital charges for items and services.
In January 2021, CMS began proactive audits of hospital websites as
well as review of complaints submitted to CMS via the hospital price
transparency website. In April 2021, CMS 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. Hospitals that fail
to submit a corrective action plan or comply with the requirements of a
corrective action plan could be issued a notice of imposition of a
civil monetary penalty (CMP). In the event CMS issues a civil monetary
penalty, CMS will publish the notice of the CMP on a CMS website.
In the Calendar Year (CY) 2022 Hospital Outpatient Prospective
Payment and Ambulatory Surgical Center Payment Systems Final Rule (86
Fed. Reg. 63,458), CMS finalized modifications to the hospital price
transparency regulations to increase compliance. The modifications
became effective January 1, 2022 and include the use of a scaling
factor to increase the amount of the civil money penalties based on
hospital bed count. CMS has issued the first round of warning letters
under the new rule and is currently working with all identified
hospitals to come into compliance.
HHS looks forward to working with its partners across the Federal
Government, along with Congress and other stakeholders, to examine
additional ways to increase price transparency across the health-care
industry and improve access to affordable coverage and services.
proposal to waive medicare cost-sharing for three mental health visits
Question. The President's Fiscal Year (FY) 2023 budget includes a
legislative proposal to waive the Medicare Part B deductible and
Medicare Part B coinsurance for three mental health visits per year.
The FY 2023 budget also includes a proposal that would prohibit
Medicare Advantage (MA) plans from applying the deductible or cost
sharing for the first three mental health visits that a Medicare
beneficiary receives each year. Finally, the FY 2023 budget also
includes a related legislative proposal to require that group health
plans and health insurance issuers waive cost sharing for three mental
health visits and three primary care visits each year.
The Senate Committee on Finance is developing bipartisan
legislation to address barriers to mental health care and substance use
disorder services. As a part of that process, the committee has
examined many of the same policies that are proposed in the FY 2023
budget, such as breaking down statutory limits on psychiatric care in
Medicare and allowing more types of mental health practitioners to bill
for Medicare services. The proposal to waive Medicare cost sharing for
three mental health visits is a policy where the committee would
benefit from additional details.
How would ``mental health visits'' be defined in the President's
budget proposal?
Would initial evaluations that result in the diagnosis of a mental
health condition be included in the definition?
Would visits and services for individuals with substance use
disorders be included in the cost-sharing waiver policy?
Would substance use disorder services be included even if there is
not a cooccurring mental health disorder diagnosis?
Does HHS or CMS have a projected number of Medicare beneficiaries
who would receive services each year for which the cost-sharing waiver
would apply?
Answer. The President's FY 2023 budget includes new historic
mandatory investments at HHS totaling $51.7 billion over 10 years to
improve behavioral and mental health. Behavioral health is an umbrella
term that includes mental health and substance use disorders, life
stressors and crises, stress-related physical symptoms, and health
behaviors. Among the numerous proposals that would increase access to
affordable behavioral health care, the budget includes proposals to
require Medicare and private insurance to cover three behavioral health
visits per year with no cost sharing.
Currently, Medicare Part B includes coverage of behavioral health
visits to a doctor, therapist, or other clinician for services
generally received outside of a hospital, but the annual Part B
deductible and coinsurance apply, with limited exceptions. This
proposal would require Medicare to cover up to three behavioral health
visits per year without cost sharing. Eligible visits would include
those for routine and lower-intensity services, such as psychiatric
evaluation.
The budget also includes a proposal that would require health
insurance issuers, group health plans, and Federal Employees Health
Benefits Program plans to cover three primary care visits and three
behavioral health visits without imposing cost sharing. For high-
deductible health plans, these services would be considered pre-
deductible for meeting Health Savings Account requirements.
Eliminating cost sharing for individuals removes potential
financial barriers to treatment and gives more patients access to the
care they need. These proposals would have a positive impact on health
equity by improving access and adherence to treatment, creating a
pathway to better overall health outcomes.
proposal to establish medicare coverage for digital applications
and platforms for mental health
Question. The President's FY 2023 budget includes a legislative
proposal to establish Medicare coverage of evidence-based digital
applications and platforms that facilitate the delivery of mental
health services. As the Senate Committee on Finance develops
legislation to address barriers to mental health care and substance use
disorder services, it will be important to gain additional detail on
this proposal.
Is it possible for Medicare to establish coverage for these digital
applications (hereinafter ``apps'') and platforms via existing national
or local coverage determination processes?
Would this FY 2023 budget proposal require the creation of a new
benefit category in Medicare or could coverage for these digital apps
and platforms be incorporated into an existing Medicare benefit?
Does HHS or CMS have any criteria that Congress should consider for
determining the scope of digital apps and platforms that should be
covered by Medicare?
Would information sharing between the apps and a patient's
physician or mental health provider be a required aspect of the
operation of Medicare-covered digital apps and platforms?
Would Medicare payment for the digital apps and platforms be built
into an existing Medicare payment system or would a new payment system
need to be created?
If Medicare payment for digital apps and platforms were added
within an existing Medicare payment system, which payment system would
be used?
Answer. The President's FY 2023 budget includes a proposal to
modernize Medicare mental health benefits, including by providing for
coverage of evidence-based digital applications and platforms that
facilitate the delivery of mental health services. This proposal would
also allow Medicare payment and billing by a broader set of
practitioners who furnish mental health services, including licensed
professional counselors and marriage and family therapists, and would
remove limits on the range of covered services that clinical social
workers can furnish under Medicare. HHS would welcome the opportunity
to provide technical assistance and work with Congress on this
proposal.
Also included in the FY 2023 President's budget is a request for
increased funding for the Agency for Healthcare Quality Research (AHRQ)
digital health research portfolio. AHRQ's Digital Healthcare Research
Program provides foundational research to ensure that digital health-
care systems are designed and implemented in ways that improve quality,
safety, and equity while not resulting in excessive burden on
physicians and other members of the care team. The program also funds
research to create actionable findings around ``what and how digital
health-care technologies work best'' for its key stakeholders:
patients, clinicians, and health systems working to improve health-care
quality. In executing this portfolio, AHRQ also operates in
coordination with other Federal health programs, particularly the
Office of the National Coordinator for Health IT, and its research
findings have informed policy at Federal entities such as CMS and the
Department of Veterans Affairs. HHS looks forward to working with
Congress and other stakeholders to examine ways Medicare can increase
access to mental health services, including through coverage of
evidence-based technology such as digital applications and platforms.
medicare advantage provider directory accuracy
Question. Inaccurate provider network directories can create
barriers to care as patients try to find an in-network provider for
their health needs. In addition, inaccurate directories raise questions
about the adequacy of plan provider networks and whether these plans
are maintaining a network of appropriate providers that is sufficient
to provide adequate access to covered services to meet the needs of the
population. A 2018 CMS report, Online Provider Directory Review Report,
found that nearly 50 percent of the provider directory locations had at
least one inaccuracy. Some of these inaccuracies included incorrect
specialty, the provider should not be listed in any of the directory-
indicated locations, and that the provider was not accepting new
patients.
Since 2018, has CMS conducted any further studies of provider
directory accuracy?
Since 2018, what enforcement actions has CMS taken to ensure
Medicare Advantage beneficiaries have access to accurate and up to date
provider directories?
What are the enforcement actions CMS can take should the agency
find a Medicare Advantage plan directory to be non-compliant with CMS
requirements?
Has CMS examined whether provider directory inaccuracies would have
resulted in the Medicare Advantage plan falling out of compliance with
CMS's network adequacy requirements?
Has CMS examined the provider directory accuracy with respect to
mental health and substance use disorder professionals? If so, what are
the results?
Answer. Provider directories are an important tool that Medicare
Advantage enrollees use to select and contact their physicians and
other contracted providers who deliver care. Beneficiaries and their
caregivers rely on provider directories to make informed decisions
regarding their health-care choices. Inaccurate provider directories
can create a barrier to care and raise questions regarding the adequacy
and validity of the MAO's network as a whole. CMS is committed to
continuing to work with MAOs to improve the accuracy of provider
directories.
CMS maintains and enforces guidance on provider directories for
Medicare Advantage plans. CMS regulations require organizations to
provide the number, mix, and geographic distribution of providers from
whom enrollees may reasonably be expected to obtain services. This
information must be provided to each enrollee in a clear, accurate, and
standardized form. Regulations also require MAOs to adhere to all
regulations and general instructions and to disclose information to
beneficiaries in the manner and the form prescribed by CMS. Each MAO
must post an online provider directory on its website. CMS is taking
steps to enforce its requirement that MAOs, Medicaid and CHIP FFS
programs, Medicaid managed care plans, and CHIP managed care entities
make standardized information about their provider networks available
through a Provider Directory API that is conformant with the technical
standards finalized by HHS in the ONC 21st Century Cures Act final
rule.
______
Questions Submitted by Hon. Mike Crapo
telehealth
Question. Bipartisan and bicameral leaders of the Finance, Energy,
Commerce, and Ways and Means committees recently worked to secure a
crucial 5-month extension for key Medicare telehealth flexibilities,
ensuring that seniors across the country can continue to access these
vital services beyond the end of the public health emergency.
While the President's budget request signals support for temporary
policies along these lines, it includes no longer-term telehealth
coverage plan, exacerbating the risk of a coverage cliff for older
Americans. The proposal also lacks meaningful sources of Medicare cost
savings, which could make funding an extension of any length more
challenging.
How does the administration envision the path forward for Medicare
telehealth access, in terms of both policy substance and financing?
Answer. During the COVID-19 public health emergency, telehealth has
been a reliable resource, allowing 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 coverage under Medicare beyond the
declared COVID-19 public health emergency 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 health
care, among other services. Medicare beneficiaries can access care
directly in their homes thanks to recent regulations, including CMS's
CY 2022 Physician Fee Schedule final rule, that allow for certain
behavioral health services via audio-only telephone calls. In addition,
the President's FY 2023 budget includes a proposal to remove statutory
limits on the list of providers 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.
drug price controls
Question. The budget request contains a concerning placeholder for
a revived tax and spending package, which includes drug pricing
policies with grave implications for new treatments, R&D, and front-
line health-care providers. The House-passed Build Back Better Act,
which appears to be the basis for these provisions, would create a
government price-setting program enabling Federal officials to impose
price controls on an ever-growing number of medications.
As part of this process, the bill would prohibit manufacturers,
most of which are small businesses, from opting out or declining the
price set by the Secretary. Non-compliance would trigger a seemingly
unconstitutional 95-percent penalty on all gross sales, and the
proposal permanently prevents judicial review, stripping the program of
any accountability. These government price controls, in short, are
negotiation in name only.
Under these proposals, the individual holding your position would
have the ability to set prices for selected drugs unilaterally, with no
recourse or appeal, even for an egregiously low price that could
trigger shortages or take a medicine off the market. How would an
unaccountable program along these lines preserve confidence in would-be
startups, researchers and investors that incentives for American
innovation remain strong?
Answer. HHS looks forward to working with the Congress to lower
health-care 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. In September
2021, HHS released a comprehensive plan to lower drug prices.\3\ The
Drug Pricing Plan presents principles for equitable drug pricing reform
through competition, innovation, and transparency; describes promising
legislative approaches; and summarizes actions already underway or
under consideration across HHS.
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\3\ https://aspe.hhs.gov/reports/comprehensive-plan-addressing-
high-drug-prices.
One of the key policies in this effort is legislation that would
allow the Secretary of HHS to negotiate Medicare Part B and Part D drug
prices directly with pharmaceutical companies and make those prices
available to other purchasers, an approach that is projected to
generate reductions in patient cost sharing and large savings for
patients, government, and commercial payers. The Drug Pricing Plan also
describes the administrative tools HHS can use to promote competition
and reduce drug prices, including testing models through CMS's
Innovation Center and collecting more data from insurers and Pharmacy
Benefit Managers to improve transparency about prices and out-of-pocket
---------------------------------------------------------------------------
spending on prescription medications.
HHS is committed to continuing our work to make health care more
affordable for American families. By promoting negotiation,
competition, and innovation in the health-care industry, HHS will
ensure cost fairness and protect access to care.
medicaid as a social safety net program
Question. Due to the continuous coverage requirement in place
during the public health emergency, Medicaid and CHIP enrollment is now
at record highs of over 86 million beneficiaries. However, rather than
transitioning individuals to the most appropriate coverage when the
public health emergency ends, recent guidance suggests that this
administration seeks to keep people on Medicaid for as long as
possible. This represents a concerning shift in the purpose of the
program.
Care for the traditional Medicaid populations--children,
individuals with disabilities, pregnant women, and the elderly--
regularly fails to meet the standards those populations deserve,
particularly when they are dually eligible for Medicare or receiving
long-term care.
States play an integral role in the delivery and design of Medicaid
benefits, and must budget appropriately for those services.
Unfortunately, misaligned Federal Government incentives often result in
the de-prioritization of traditional Medicaid populations. What reforms
should Congress consider to reverse these trends?
Answer. Medicaid provides health coverage to millions of Americans,
including low-income adults, children, pregnant individuals, elderly
adults, and people with disabilities. The Biden-Harris administration
is committed to ensuring that every eligible person can access the
coverage and care to which they are entitled. It has been a top
priority to ensure, when the public health emergency (PHE) eventually
ends and States resume routine operations including terminations of
eligibility, that renewals of eligibility and transitions between
coverage programs occur in an orderly process that minimizes burden for
all beneficiaries and promotes continuity of coverage.
In March, HHS released new guidance and planning and communications
tools that offer States a road map to restore routine eligibility and
enrollment operations after the PHE ends; promote continuity of
coverage; and facilitate transitions between Medicaid, CHIP, the Basic
Health Program, the Health Insurance Marketplaces, and Medicare. In
April, HHS also released a proposed rule that would smooth transitions
between Medicaid and Medicare during the unwinding period by allowing
certain Medicaid enrollees to enroll in Medicare without late
enrollment penalties. HHS is committed to working together with
Congress to ensure that all beneficiaries remain a priority.
the importance of faith-based child welfare organizations
Question. According to your department, our foster care system
served more than 400,000 children in FY 2020. While this represents a
reduction from the previous year, we are hearing from States that they
are struggling to find homes and placements for foster youth.
In many States, faith-based organizations provide the majority of
child welfare services. In order to prioritize the well-being and
safety of this vulnerable population, the Federal Government must
continue to collaborate and support a wide variety organizations
dedicated to providing these services.
How does your budget help to address the shortage of foster parents
and foster homes, and how can faith-based providers help address this
shortage?
Answer. The Administration for Children and Families' Children's
Bureau recognizes that faith-based providers make important,
longstanding contributions to human service programs, including in
terms of recruiting foster parents.
The budget proposes to expand the use of evidence-based foster care
prevention services, which would safely reduce the number of children
entering the foster care system and needing foster parents and homes.
When children do need to be removed from their home, the budget seeks
to ensure more children are placed with family members or other adults
with existing emotional bonds with the child, including by providing
additional funds to help kin caregivers navigate the child welfare
system and incentivizing States to focus on kin placements whenever
feasible. The budget's proposals would help ease the challenges of
finding additional foster care placements. In many States, faith-based
providers would play a role in providing prevention services and/or
working with kin caregivers, while ensuring all families have equal
access to publicly funded child welfare services and are treated with
dignity and respect by the child welfare system.
Additionally, on behalf of the Children's Bureau, the Capacity
Building Center for States provides targeted and tailored technical
assistance to State and territorial public child welfare agencies on
identified needs that span the child welfare continuum. Priorities are
identified through comprehensive assessments and services focus on
ensuring the safety, permanency, and well-being of all children, youth,
and families. Services are provided in response to requests from
jurisdictions and may focus on everything from in-home and prevention-
focused efforts to enhancing independent living services for youth and
young adults, and promotion of successful transitions from foster care
into adulthood. Services in support of diligent recruitment efforts and
the recruitment and retention of foster parents and foster homes are
available, including expertise in the engagement of faith-based
providers to address shortages. In addition to direct technical
assistance services, the Center for States facilitates learning and
problem solving through the support of peer groups, such as the
Diligent Recruitment Peer Group, as well as through the development of
tools and resources including the Engaging Faith-Based Communities to
Achieve Timely Permanency for Children and Youth Waiting to Be Adopted
which provides strategies and examples of how to partner with faith-
based communities and leaders on behalf of children and youth in foster
care waiting to be adopted.
the increasing rate of infant and toddlers entering the foster care
system
Question. A 2019 report by Child Trends analyzing the Adoption and
Foster Care Reporting System (AFCARS) data found that during the last
10 years, the rate of foster care entries for infants and toddlers has
far exceeded the rate for older children and has driven the overall
increase in foster care entry rates.
What more can be done by the administration and jurisdictions to
address infants and toddlers coming into care at such a high rate?
Answer. For Federal fiscal year 2020, there were 618,000 victims of
child abuse and neglect in the United States. The victim rate was 8.4
victims per 1,000 children in the population. Children younger than 1
year old had the highest rate of victimization at 25.1 per 1,000
children of the same age in the national population. Children under the
age of one also had the highest entry into foster care. Nationally,
43,694 infants under the age of 1 entered foster care in Federal fiscal
year 2020, which represents 20 percent of the total number of children
entering foster care during this period. As noted, the Capacity
Building Center for States, on behalf of the Children's Bureau,
provides targeted and tailored technical assistance to State and
territorial public child welfare agencies on identified needs that span
the child welfare continuum. Priorities are identified through
comprehensive assessments and services focus on ensuring the safety,
permanency, and well-being of all children, youth, and families and are
available to address specific challenges, including the frequency of
infants and toddlers coming into care. Services are provided in
response to requests from jurisdictions and may support the enhancement
of in-home and prevention-focused efforts to keep families intact and
avoid children and youth from unnecessary entry into care. Problem
solving and practice sharing is also available through Center for
States' supported peer groups including the In-Home and Promoting Safe
and Stable Families Managers and the Family First Prevention Services
Act Prevention Plan Leads.
The National Center on Substance Abuse and Child Welfare (NCSACW)
provides two specialized technical assistance (TA) programs, In-Depth
Technical Assistance (IDTA) and Regional Partnership Grants (RPG), that
prevent infants' and young children's placement in out-of-home care by
providing comprehensive services to families affected by substance use
and mental health disorders. Both TA programs work with selected
grantees or sites to increase their capacity to improve the safety,
health, permanency, well-being, and recovery outcomes with equity for
all infants, toddlers, and their families affected by substance use
disorders (SUDs). The programs achieve this objective by helping
States, counties, and tribes build linkages among SUD prevention and
treatment systems, child welfare, courts, public health, health-care
providers, early intervention, Early Head Start and Head Start, and
other systems and agencies serving children and families. IDTA
strengthens broader cross-system practices that support family-centered
approaches, improved outcomes, and strengthens workforce development.
Since 2017, the IDTA program has focused specifically on infants and
their families affected by prenatal substance exposure and implementing
plans of safe care (POSC) in concert with requirements in the Child
Abuse Prevention and Treatment Act. Innovations implemented by IDTA
sites include States that are moving beyond compliance with POSC
requirements to prevent infant placements and future involvement in the
child welfare system by implementing POSC during the prenatal period.
Several States are also developing notification pathways for families,
if there are no immediate safety concerns that would necessitate a
mandated report, including families in this group with prenatal
exposure to medication for opioid use disorder. They are implementing
partnerships with home visiting, early childhood providers, and
community-based information and referral programs to provide support in
the community that prevents child placement.
ACF is currently initiating data collection for the program
evaluation of the fifth and sixth rounds of RPGs, and previous rounds
of evaluation have consistently found that the majority of children at
risk of removal remained in their parent's custody following enrollment
into RPG services. Among youth who were in an out-of-home placement,
the rates of placement into permanent settings, including reunification
with their parent(s), increased significantly in the year following RPG
enrollment. In addition, the overall rates of child maltreatment
decreased substantially in the year after enrollment in the RPG
program. The 2023 budget proposes to triple the annual mandatory
appropriation for RPGs to $60 million to ensure more children have
access to this proven program to reduce the entry of children into
foster care.
In addition to providing a broad scope of training and technical
assistance in every State, the NCSACW convened a virtual 2020 Practice
and Policy Academy: Developing a Comprehensive Approach to Serving
Infants with Prenatal Substance Exposure and their Families, on August
25-27, 2020. The purpose was to advance the participating sites'
capacity to improve outcomes for pregnant and parenting women with SUDs
and their infants and families affected by prenatal substance exposure.
Eight sites assembled a multidisciplinary team of leaders committed to
strengthening their collaborations and to implementing POSC for infants
and their families. Site teams engaged in peer-to-peer learning and TA
to create a State-specific action plan to meet the multiple and complex
needs of this population. The NCSACW is in the development phase of a
2022-2023 Policy Academy that will allow up to 10 States, Tribes, or
large counties to participate in the 6-month pre-and post-Academy
technical assistance as well as to apply for ongoing assistance through
the IDTA program.
the maternal, infant, early childhood visiting program
Question. The Maternal, Infant, Early Childhood Visiting Program
(MIECHV) program has successfully served many families across Idaho and
the rest of the Nation. The trained workforce providing critical
support to families from pregnancy through their child's first years of
life has been a lifeline before, and especially during the pandemic.
As this committee works in a bipartisan fashion to reauthorize this
program, how would the agency allocate the new funding included in your
budget to better serve families across the United States?
Answer. The FY 2023 President's budget requests $467 million for
MIECHV, a $67-million increase per year each year for 5 years, with the
full program budget totaling $735 million in FY 2027. MIECHV-funded
programs currently serve 71,000 families at the current appropriation
level of $400 million per year. Over the 5 years, HRSA anticipates this
funding increase would provide targeted evidence-based home visiting
services to up to 165,000 additional families.
In FY 2023, new funding for the MIECHV program would address unmet
needs by expanding service capacity in all 50 States, the District of
Columbia, and five U.S. territories. The additional funding would allow
awardees to address ongoing challenges such as shoring up workforce
capacity, improving compensation for home visitors, and promoting
stronger workforce recruitment and retention efforts. Home visiting
programs have reported gaps in these areas.
By statute, 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. An increase in
overall appropriation will also increase the dollar amount to this set-
aside.
mced legislation
Question. Multi-cancer early detection tests have the potential to
transform the cancer screening landscape, detecting as many as dozens
of different cancer types, often long before symptoms even emerge.
Without Medicare coverage, however, these types of tests may remain out
of reach for many seniors. Fortunately, legislation creating a coverage
pathway for these technologies enjoys broad bipartisan and bicameral
support.
In outlining goals for the reignited Cancer Moonshot, the
President's budget references the promise of multi-cancer early
detection tests. What role do you see for Medicare in ensuring access
to these technologies, and can you commit to working with the bill's
sponsors on advancing this vital legislation?
Answer. In February 2022, President Biden announced that he is
reigniting the Cancer Moonshot initiative he launched as Vice President
in 2016. The Cancer Moonshot sets ambitious goals: to reduce the age-
adjusted death rate from cancer by at least 50 percent over the next 25
years, and to improve the experience of people and their families
living with and surviving cancer. The President and First Lady Jill
Biden also announced a call to action on cancer screening to jumpstart
progress on screenings that were missed as a result of the COVID-19
pandemic, and to help ensure that everyone in the United States
equitably benefits from the tools we have to prevent, detect, and treat
cancer.
Today, we know cancer as a disease for which there are stark
inequities in access to cancer screening, diagnostics and treatment
across race, gender, region, and resources. This administration is
committed to ensuring that every community in America--including those
living in rural, urban, and Tribal communities--has access to cutting-
edge cancer diagnostics, therapeutics, and clinical trials.
With regard to Medicare, CMS prioritizes expanding access to these
essential preventative health-care services, including cancer
screenings. Medicare beneficiaries pay zero cost sharing for cancer
screenings that are preventive services recommended by the United
States Preventive Services Task Force (USPSTF) with a grade of A or B
for any indication or population and that are appropriate for the
individual. HHS looks forward to working with partners across the
Federal Government, along with Congress and other stakeholders, to
examine ways we can increase access to services for the prevention,
diagnosis, treatment, and survival of cancer. 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 https://www.whitehouse.gov/cancermoonshot/.
the medicare coverage of innovative technology (mcit) rule
Question. Far too often, lags in Medicare's coverage process delay
access to potentially lifesaving technologies, ranging from cutting-
edge treatments to game-
changing diagnostic tools. Backed by broad bipartisan support, the
previous administration finalized a rule that would have expedited
coverage for safe and effective breakthrough devices, increasing care
quality for scores of American seniors.
Unfortunately, last year, the Biden administration rescinded this
rule, preserving the status quo of access delays, including for truly
groundbreaking advances in diagnosing, preventing and treating a broad
range of conditions.
Could you provide an update on the administration's progress
towards developing and advancing the regulatory changes to address
these persistent coverage challenges, given the groundswell of
bipartisan support for solutions?
Answer. CMS remains committed to expanding access to health-care
coverage and services, including new, innovative treatments when they
are safe and appropriate. CMS rescinded the Medicare Coverage of
Innovative Technology and Definition of ``Reasonable and Necessary''
(MCIT/R&N) final rule because of concerns that the provisions in the
final rule may not have been sufficient to protect Medicare patients.
By rescinding this rule, CMS will take action to better address those
safety concerns in the future.
Improving and modernizing the Medicare coverage process continues
to be a priority, and we remain committed to providing stakeholders
with more transparent and predictable coverage pathways. CMS is working
as quickly as possible to advance multiple coverage process
improvements that provide an appropriate balance of access to new
technologies with necessary patient protections. As part of this
effort, CMS is conducting several listening sessions to learn about
stakeholders' most pressing challenges and to receive feedback from
stakeholders about which coverage process improvements would be most
valuable.
CMS intends to explore coverage process improvements that will
enhance access to innovative and beneficial medical devices in a way
that will better suit the health-care needs of people with Medicare.
This will also help to establish a process in which the Medicare
program covers new technologies on the basis of scientifically sound
clinical evidence, with appropriate health and safety protections in
place for the Medicare population. HHS looks forward to working with
you and hearing your feedback as we move forward with these efforts.
a plan for shoring up hospital insurance trust fund solvency
Question. Current law requires the Medicare trustees to determine
whether projected annual general revenue funding will exceed 45 percent
of total Medicare outlays during the next 7 fiscal years. Two
consecutive determinations along these lines trigger a Medicare excess
general revenue funding warning. In 2021, the trustees once again
established that Medicare will exceed the general revenue outlay
threshold.
By law, when Medicare enters this situation, the President must,
within 15 days of his next budget, submit a detailed plan to Congress
that saves Medicare from bankruptcy and preserves the program for
future generations.
If the 2022 Medicare trustees report includes yet another funding
warning, will President Biden follow the law and immediately propose a
detailed plan--including policy specifications and corresponding cost
estimates--to extend the life of the HI trust fund?
debt, deficits, and mandatory spending
The FY 2023 budget request would cause GDP growth to drop to just a
little over 2 percent annually starting in 2023. It steadily increases
overall debt held by the public year-over-year through 2032, in
addition to adding more than $1 trillion to the deficit each year. The
budget imposes over $2.5 trillion in tax increases and proposes more
than $900 billion over 10 years in new, mandatory spending.
President Biden has promoted an unserious tax and spend budget--one
that ignores the financial status of the Medicare hospital insurance
trust fund. Every recent President, Republican and Democrat, has
offered Medicare savings proposals in budget requests submitted to
Congress. Many of those budgets even contained identical policy ideas.
Rather than use the budget as a platform to kick-start bipartisan
discussions about ways we can shore up Medicare for the long haul, the
document simply concedes that the Medicare HI trust fund is on the
brink of insolvency, and that the Biden administration has absolutely
no ideas to fix it.
The budget proposes some increases in Part A spending, but offers
no specific Part A offsets to pay for that spending. Do you agree that
this is irresponsible given that the HI trust fund is in near-term
financial crisis?
Answer. The President is committed to protecting and strengthening
Medicare so that Americans of every generation can count on it. The
President's budget proposes investments in Medicare that incentivize
physician participation in value-based payment models designed to help
drive down overall health-care costs and improve patient outcomes by
rewarding value and quality of care, rather than volume of physician
services. The budget also proposes strengthening program integrity
tools and authorities to identify and investigate fraud in services
covered through the Medicare Advantage program, and enforcing new
penalties on bad actors. Additionally, the budget invests in program
integrity allocation adjustments that fight fraud, waste, and abuse in
Medicare.
As we continue to make reforms that improve and strengthen
Medicare, we should be looking to reduce costs, not benefits. HHS looks
forward to working with you and the Congress to find bipartisan
solutions to ensure that Medicare is strong for current and future
beneficiaries.
access to low-volume, high-cost therapies
Question. Certain patients can face acute access issues in the
hospital inpatient setting of care. Rare disease treatments, in
particular, are provided to such small numbers of patients that they do
not have a significant effect on the average cost for a Medicare
Severity-Diagnosis Related Group (MS-DRG).
Last year, CMS acknowledged that it needed more time to consider
how best to ensure access to low-volume, high-cost therapies, such as
rare disease therapies, under the Medicare Hospital Inpatient
Prospective Payment System (IPPS).
What is CMS doing to modernize the IPPS so that patients living
with rare diseases have access to personalized treatments in the
inpatient setting?
Answer. CMS is committed to ensuring beneficiary access to the
treatment and care they need. In the FY 2023 Hospital Inpatient
Prospective Payment System and Long-Term Care Hospital Prospective
Payment System Proposed Rule, the agency is soliciting public comments
on how the reporting of certain diagnosis codes may improve our ability
to recognize severity of illness, complexity of illness, and
utilization of resources under the diagnosis related groups, as well as
feedback on mechanisms to improve the reliability and validity of the
coded data as part of an ongoing effort across CMS to evaluate and
develop policies to reduce health disparities. In concert with that
effort, we are also soliciting comments to explore possible mechanisms
through which we can address rare diseases and conditions that are
represented by low volumes in our claims data.
ensuring access to medications
Question. A number of front-line providers and cancer care
advocates have expressed concerns over the Centers for Medicare and
Medicaid Services' (CMS) interpretation regarding mail-order drugs
being excluded from the in-office ancillary exception to the Stark Law
prohibitions. Preventing cancer clinics from providing lifesaving
treatments through their mail-order pharmacies risks severely
disrupting care, in addition to placing undue burdens on patients who
are forced to absorb travel costs, time away from work, and other
strains. These disruptions could prove particularly problematic for
patients living in rural communities.
In the context of the ongoing public health emergency (PHE), HHS
has helped to address this dynamic by waiving certain portions of the
Stark Law, including the ``location requirement,'' enabling clinics to
utilize mail-order drugs for patients who were observing social
distancing in their homes. However, patients and providers face
uncertainty as to what might happen when the PHE ends.
In the past, CMS has utilized language in the statute to carve out
mail-order if there is no risk of program or patient abuse. In 2001,
CMS issued a final Stark Phase One rule that allowed mobile facilities
used exclusively by a group practice to count under the exception. It
would be appropriate to make similar concessions in this context to
ensure patients continue to have timely access to lifesaving treatment
without additional cost burdens.
Can you clarify that under current Stark prohibitions, mail-order
drugs are excluded from the in-office ancillary exception?
If so, will the agency explore using additional authority to
provide an exception to the ``location requirement'' to prevent
disruptions in patient care?
Answer. CMS strives to ensure that sufficient health-care services
are available to meet beneficiaries needs. The ``location requirement''
at 42 CFR Sec. 411.355(b)(2) would not be satisfied if a patient
receives an item by mail outside the physician's office, as it would
not be dispensed to the patient in the office. However, CMS issued
blanket waivers in March 2020 that apply during the COVID-19 public
health emergency (PHE) to allow certain flexibilities, and under the
waiver of a referral by a physician in a group practice for medically
necessary designated health services furnished by the group practice in
a location that does not qualify as a ``same building'' or
``centralized building'' for purposes of 42 CFR 411.355(b)(2), the
furnishing of mail-order drugs is permitted. CMS is currently reviewing
certain flexibilities to evaluate whether they are appropriate beyond
the PHE and we will continue to consider ways to ensure that
beneficiaries receive access to high quality, value-based care, while
maintaining appropriate safeguards.
______
Questions Submitted by Hon. Sherrod Brown, Hon. Chuck Grassley,
Hon. Robert P. Casey, Jr., and Hon. John Barrasso
medicare pharmacist provider status
Question. We appreciate the steps CMS has taken throughout the
COVID-19 pandemic to increase access to care, especially in rural and
urban underserved areas. In particular, we support CMS's efforts to
empower community pharmacists to serve as Medicare providers to
increase access to testing and get shots in arms.
While we recognize that current statute limits the capacity of
licensed pharmacists to provide and bill Medicare directly for
professional services, we appreciate efforts by CMS to facilitate
pharmacists as providers in the Medicare program through existing
authorities and we are encouraged by the potential for pharmacists to
continue to serve their communities as Medicare providers following the
end of the COVID-19 public health emergency (PHE) designation.
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:
Will pharmacists continue to receive reimbursement for COVID-19
tests and vaccine administration if they are enrolled as a CLIA lab and
mass immunizer, respectively?
Will pharmacists continue to receive reimbursement ``incident to''
another provider billing under their own NPI when the ``direct
supervision'' requirement is met virtually?
Can Medicare Part B directly reimburse a pharmacy or pharmacist for
administering vaccinations without mass-immunizer enrollment?
Can Medicare Part B directly reimburse a pharmacist for COVID-19,
influenza, RSV, or strep testing services, including specimen
collection, if the pharmacy does not have a CLIA Certificate or
Certificate of Waiver?
Does CMS have the regulatory authority to expand pharmacist
provider status beyond COVID-specific services? If so, do those
authorities exist solely under mass immunizer and laboratory pathways
to reimbursement under Part B, or are there other pathways to more
permanent authorities for pharmacists to administer and get directly
reimbursed for COVID-specific services as authorized under State scope
of practice laws?
Answer. We believe that pharmacists are essential parts of our
health-care 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.
______
Questions Submitted by Hon. Robert Menendez
covid-19 abroad
Question. The administration requested $5 billion in supplemental
funds to respond to the impacts of COVID-19 abroad, including $750
million for the CDC. It seems unlikely that Congress will appropriate
any supplemental funds for global COVID operations in the immediate
future. Many prominent health and development advocates have said that
the U.S. needs to invest at least $17 billion if we want to meet our
stated goal of vaccinating 70 percent of the world by the end of the
year.
What will be the impact on our efforts to support President Biden's
goal of helping to vaccinate 70 percent of the world by September if
Congress falls short of the $5-billion request for the Global VAX
initiative?
Answer. Ending the COVID-19 pandemic is a top priority for this
administration both domestically and globally, because no country is
safe until we are all safe. The best way to prevent the emergence of
future variants that could threaten the health of Americans and
undermine our economic recovery is to vaccinate the world. As more
COVID-19 vaccine supply flows to low-and middle-income countries, the
United States and other donors must redouble efforts to help countries
efficiently receive, distribute, and administer doses. Without
additional efforts, further COVID-19 variants that pose risks to not
only other countries, but also to U.S. lives, our economy, and our
national security will develop.
The pandemic has made it clear that we need effective international
institutions that can quickly detect and respond to emerging health
threats, and strengthen the health systems that will prevent future
pandemics. As the United States' representative to the World Health
Organization, HHS plays a critical role in strengthening and reforming
the WHO--a priority for the US, according to National Security
Memorandum 1. There are a wide range of important but complicated
changes that can be made to the WHO, including reforms to the
International Health Regulations, improving the sustainability of the
WHO's financing, and negotiating an international instrument to
strengthen pandemic preparedness, prevention, and response--the so-
called ``pandemic treaty.''
Question. What is the administration's top priority in terms of WHO
reform?
Answer. The United States wants to strengthen the role of member
states in WHO governance, specifically in determining the strategic
direction and core functions of WHO. In addition, several high-priority
areas where we understand there is member state consensus to move
forward quickly include WHO governance; budget and financial
transparency and oversight; accountability and oversight; allocation of
resources among headquarters, regional and country offices; human
resources management; and compliance, risk management, and ethics.
Improvement in the integrity of WHO's misconduct investigation
activities, especially those dealing with claims involving sexual
exploitation, abuse, sexual harassment, and abusive conduct, and in
their work to prevent and respond to such conduct is also a key area
for reform.
The administration is pursuing targeted amendments to the
International Health Regulations (IHR) 2005 to allow for more efficient
and effective updating of this foundational legally binding instrument.
The United States is currently leading discussions with member states
to pursue proposed amendments, including working together to amend
Article 59 of the IHR to shorten the effective date for amendments, and
additional, more substantive amendments.
Question. Considering other countries' disagreements over some of
the proposed reforms, how optimistic are you that the U.S. will achieve
its goals to reform the WHO?
Answer. We believe that it is important for changes to be made to
ensure that the world is prepared. At the World Health Assembly Special
Session held last November, there was almost universal support for
strengthening the WHO and the International Health Regulations. We
expect member states to follow through on their political statements
with concrete actions at this 75th WHA and will continue to push for
action. We remain optimistic and committed to working with member
states and WHO to strengthening WHO so that it may be more
authoritative, effective, transparent, and agile.
Question. Where do things stand with effort related to negotiating
a pandemic treaty?
Answer. The Intergovernmental Negotiating Body (INB) has begun its
work on a pandemic instrument. The United States government is
committed to the INB process and to developing an international
instrument that enables meaningful action, transparency, and
accountability for pandemic prevention, preparedness and response. The
United States government is developing its proposals for substantive
elements through an interagency and is looking to see what other member
states will provide in the lead-up to the June 6-8 meetings in Geneva.
community violence
Question. Last year, the President's budget proposed the creation
of a new Community Violence Intervention (CVI) initiative to address
gun violence. Under this year's proposal, your agency would receive
$250 million to continue funding these Community Violence Intervention
programs.
What is the importance of that funding for the Department's efforts
to address gun violence in communities across the country?
Answer. In 2020, there were 45,222 firearm-related deaths in the
United States--that's about 124 people dying from a firearm-related
injury each day. More than half of firearm-related deaths were suicides
and more than 4 out of every 10 were firearm homicides. Firearm-related
injuries were among the five leading causes of death for people ages 1-
44 in the United States. The Community Violence Intervention (CVI)
initiative aims to reduce all forms of community violence, including
violence perpetrated by firearm. With the funding proposed in the
President's budget, CDC would fund up to 75 cities and communities that
are highly impacted by homicide to establish a collaborative, community
driven approach to reduce community violence.
Question. What plans does HHS have to expand existing CVI programs?
What additional resources are needed to do so?
Answer. The FY 2023 President's budget proposes a $250-million
investment in the new community violence intervention initiative for
CDC. With these funds, CDC would build upon the foundation of our 20-
plus years of science-based youth violence prevention effort to fund up
to 75 cities and communities with high numbers of homicides and
communities with high numbers of homicides per capita to establish a
collaborative, community driven approach to reduce community violence.
Funds will support scaling up existing community violence prevention
efforts and implementing and evaluating evidence-based and evidence-
informed community violence prevention strategies.
CDC would also fund community-based organizations that have
expertise in partnering with communities most impacted by community
violence to provide training technical assistance to funded
communities. CDC would also expand 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. This would include expanding the scope of the Youth
Violence Prevention Centers (YVPCs) to include young adults and funding
up to seven more centers. This would also include additional awards to
address critical research gaps to enhance what is known about what
works to prevent community violence, including prevention strategies
that address the structural determinants of health that contribute to
violence inequities (such as concentrated disadvantage, structural
racism, discrimination, disinvested communities, poverty, limited
educational opportunities, and unemployment).
diversity in clinical trial participants
Health-care equity and reducing disparities are hot topics in
Congress and the administration but real action has been slow to meet
these challenges. As we think about all of our medical treatments we
have--or in some cases don't yet have--it begins with research, and
today we still have a long way to go to realize research equity. Our
clinical trials must mirror our Nation and we will not see that
reflection until we reduce barriers for traditionally excluded
populations to participate in clinical trials.
What can HHS do to level the playing field, and do you think the
provisions in the DIVERSE Trials Act, my bill with Senator Scott, would
help--particularly those provisions that create safe harbors to provide
trial participants with technology and financial assistance?
Answer. Although progress has been made to increase the enrollment
of diverse populations, there is still room for improvement. One
strategy that has not been scaled up in a sustainable way is engaging
community clinicians and investigators in research. There is
considerable evidence that clinician recommendations play an important
role in helping patients consider participating in clinical
investigations.\4\ In addition to clinicians' recommendations playing
an important role, removing barriers to participation, such as bringing
trials closer to where participants live, work, worship, and typically
receive their health care, may also help achieve more diversity in both
the workforce administering the trials and the participants in an
investigation.
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\4\ https://www.nejm.org/doi/full/10.1056/NEJMp2107331.
We understand the overall intent of the bill's language to be to
ensure that research of medical products is equitable and represents
the demographic populations that would benefit from their use. HHS
strongly supports that goal and is committed to encouraging diverse
participation in and equal access to clinical trials used to support
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marketing applications for regulated medical products.
Digital Health Technologies (DHTs) used for remote data acquisition
are playing a growing role in health care and offer important
opportunities in clinical research. Compared to intermittent trial
visits, the use of DHTs to remotely collect data from trial
participants may allow for continuous or more frequent data collection.
This may provide a broader picture of how participants feel or function
in their daily lives. DHTs provide opportunities to record data
directly from trial participants (e.g., performance of activities of
daily living, sleep) wherever the participants may be (e.g., home,
school, work, outdoors). Some DHTs also may facilitate the direct
collection of information from participants who are unable to report
their experiences (e.g., infants, cognitively impaired individuals).
There is a large spectrum of DHTs available for potential use in a
clinical investigation. FDA's draft guidance, Digital Health
Technologies for Remote Data Acquisition in Clinical Investigations,
when final, will provide recommendations for sponsors, investigators,
and other interested parties on the use of DHTs for remote data
acquisition from participants in clinical investigations evaluating
medical products.
disparities in detection and diagnosis of dementia
Question. In addition to the lack of access to clinical trials, we
know that many minority populations struggle to access timely diagnosis
of ailments. For example, recent Medicare data shows that Asian, Black,
and Latino patients were more likely to receive a later dementia
diagnosis than their White counterparts. Across all racial and ethnic
groups, only a minority of all beneficiaries received a timely dementia
diagnosis and comprehensive evaluation.
What will the administration do to narrow these disparities in the
detection and diagnosis of dementia among Medicare beneficiaries more
likely to experience disparities?
Answer. Embedding health equity within our health-care system,
including for dementia care, is a key focus of the Biden-Harris
administration. HHS is working across the Department to close gaps in
access to health care and human services in order to advance equitable
outcomes for underserved populations.
Detecting cognitive impairment is a required element of Medicare's
Annual Wellness Visit. Providers conduct a cognitive test and can
evaluate health disparities, chronic conditions, and other factors that
contribute to increased risk of cognitive impairment. If a patient
shows signs of cognitive impairment during a routine visit, Medicare
also covers a separate visit to more thoroughly assess cognitive
function and develop a care plan. CMS has developed educational
materials to ensure that providers are aware of this benefit.
HHS looks forward to continuing to work with Congress to reduce
health disparities across the health-care system, and to ensure that
all patients have access to critical services like the detection and
diagnosis of cognitive impairment.
mandatory coverage of adult vaccines
Question. The President's budget includes a proposal to consolidate
coverage of adult vaccines under Medicare Part B.
How will this improve the access experience for beneficiaries and
streamline the process for providers?
Adult rates of vaccination in the US, including for our most
vulnerable older Americans, have historically fallen short of public
health goals. These low vaccination rates are attributed to
affordability and access barriers. However, one of the most confusing
contributing factors to low vaccination rates is the lack of
streamlined coverage that assures 100 percent of Medicare beneficiaries
have access to affordable immunizations. How will the President's
proposal to consolidate all vaccines under Medicare Part B vastly
improve overall adult vaccination rates?
Answer. The COVID-19 pandemic has emphasized the importance of
vaccines and the critical role they play in preventing severe disease
and saving lives. In addition to proposing investments in the research
and development of vaccines, the President's FY 2023 budget includes
proposals to expand access to vaccines for both children and adults.
Within Medicare, the budget proposes to consolidate all vaccine
coverage under Medicare Part B.
Current Medicare coverage for vaccine administration is divided
between Part B and Part D, which can be confusing and burdensome for
both Medicare beneficiaries and providers. Part B is a more appropriate
type of coverage for vaccines because more beneficiaries are enrolled
in Part B than Part D and higher out-of-pocket costs in some Part D
plans may create a financial barrier to access. This proposal shifts
all Medicare coverage for vaccines, including administration costs, to
Part B and requires that Medicare Advantage plans charge no greater
cost sharing for any vaccines and their administration than is charged
under original Medicare. For all vaccines, as recommended by CDC's
Advisory Committee on Immunization Practices, and adopted by the CDC
Director, with the exception of vaccination for travel-
related purposes, there will be zero cost sharing for Medicare
beneficiaries. These changes promote better access to vaccines among
the Medicare population while making Medicare payment for them more in
line with actual costs. Health equity is improved by removing potential
financial barriers to CDC-recommended vaccines.
Question. In the House and Senate Appropriations Committee's
explanatory statement regarding the Fiscal Year 2022 Omnibus, the
committees required reports on HHS's plans to phase out the use of
Emergency Intake Sites and increase its licensed bed capacity. What
progress has HHS made on this goal?
Answer. ORR continues to evaluate capacity needs by closely
monitoring and reviewing several variables: unaccompanied children (UC)
referral numbers, projections and trends; COVID-19 infection rates and
impact on staffing and bed capacity; and total operational bed
capacity, including standard bed capacity. Out of the 14 EIS that were
brought online in the spring of 2021, only two remain active as of
April 2022: Pecos EIS and the ORR EIS at Fort Bliss. Though the number
of UC in ORR care has declined significantly, from nearly 20,000 in
April 2021 to approximately 10,000 in April 2022, referrals to the
program continue to be higher than historical patterns.
ORR makes efforts to ensure that its decision-making is informed by
conditions on the ground. Given DHS projections of referral increases
as well as the potential for capacity needs that can accommodate COVID-
positive UC, ORR has determined that it will need to extend the use of
the facilities at Fort Bliss and Pecos. However, ORR plans to convert
both sites into Influx Care Facilities (ICFs) within the next few
months Influx Care Facilities provide services for children consistent
with Flores Settlement Agreement (FSA) Exhibit 1 standards. In general,
ORR's policies regarding ICFs are described in ORR Policy Guide section
7, Policies for Influx Care Facilities.
ORR's preference is to place UC into standard care provider
facilities while sponsorship suitability determinations proceed, and
currently funds the highest number of beds in the standard shelter
network in the program's history. ORR consistently works on expanding
its network of standard beds by awarding funding to existing and new
grantees. For example, ORR published a Notice of Funding Opportunity
(NOFO) for licensed shelters and transitional foster care beds on
December 6, 2021, with award dates targeted for July and November 2022.
Moreover, a NOFO will be opened to organizations that have not yet
secured a license for their facilities with a timeline of achieving the
required licensure within 4 months of award, allowing ORR to partner
with previously excluded entities that share in our mission and goal to
ensure the safety and well-being of children in our care. This NOFO
will be published on May 5, 2022, with an anticipated award of November
2022. NOFOs for long term foster care, therapeutic, staff-secure, and
secure programs are also expected to publish by September 2022.
Question. In the Department of Health and Human Services' Fiscal
Year 2021 budget justification, the Department states that ORR plans to
convert Fort Bliss and Pecos, currently emergency intake sites, into
influx facilities. Like emergency intake sites, influx facilities are
not licensed and lack independent State oversight on the treatment of
children in their care. Prior reliance on influx facilities has been
costly and caused harm to children. What is this administration doing
to transition away from reliance on influx or emergency beds?
Answer. ORR establishes influx facilities to help address bed
shortages during periods of sustained increases in referrals from DHS,
and to ensure that children are transferred out of DHS's custody
swiftly. Children in temporary influx care facilities receive services
consistent with Exhibit 1 of the FSA, including case management, on-
site education, medical care, legal services, and counseling; and can
participate in recreational activities and religious services
appropriate to the child's faith, just as children in licensed
facilities. (For complete information, please see ORR Guide section
7.5: Influx Care Facility Required Services.) ORR is the primary
monitor of temporary influx care facilities and is responsible for
their oversight, operations, physical plant conditions, and service
provision. While States do not license or monitor influx care
facilities, the facilities operate in accordance with the Flores
Settlement Agreement, the Homeland Security Act of 2002, the
Trafficking Victims Protection Reauthorization Act of 2008, the Interim
Final Rule on Standards to Prevent, Detect, and Respond to Sexual Abuse
and Sexual Harassment Involving Unaccompanied Alien Children, and ORR
policies and procedures.
ORR's priority is to unify UC with vetted sponsors as safely and
quickly as possible following their arrival at an EIS, ICF, or State-
licensed care provider facility. Average length of care (ALOC) has
consistently decreased program-wide since the 2021 influx, when the
length of care numbers ranged between 31-37 days; the ALOC program-wide
as of April 2022 is 28 days. ALOC has also decreased for children
eligible for all categories of sponsors, with every child's ALOC
measured at less than 30 days.
ORR continues to ensure that vulnerable children with complex cases
or special needs are not placed at EIS or, if identified after
placement, are transferred out of an EIS, and promptly placed in a
shelter suitable to their needs.
Consistently building its network to promote standard capacity that
can adapt to the changing needs of the program, ORR considers EISs and
ICFs a last resort. This notion is also reflected in ORR's plans to
transition the two remaining EIS to ICF facilities that meet the same
minimum standards as ORR's standard shelters. This commitment is clear
in ORR's call for more partner organizations to expand ORR's network of
standard beds.
Question. The Fiscal Year 2023 budget justification indicates that
``ORR's long-term goal is to create a model of care delivery with
sufficient family foster care and licensed capacity that can adapt to
changing needs efficiently, such that influx care facilities or other
emergency shelters are needed only in exigent or emergency
circumstances.'' What is ORR's timeline for approaching this goal?
Answer. ORR is focused on bringing more standard beds online,
including adding beds to existing awards and funding new awards. A NOFO
for licensed shelters and transitional foster care beds was published
on December 6, 2021 with award dates targeted for July and November
2022. Moreover, a NOFO is expected to be published in May 2022 that
will be open to organizations who have not yet secured a license for
their facilities with a timeline of achieving the required licensure
within 4 months of award. This allows ORR to partner with previously
excluded entities who share in its mission and goal to ensure the
safety and well-being of children in our care. NOFOs for long term
foster care, therapeutic, staff-secure, and secure programs are also
expected to publish by September 2022. These awards allow ORR to ensure
that as many children as possible are cared for in licensed or soon-to-
be licensed facilities with access to the full array of services,
regardless of exigent and emergency circumstances.
Additionally, ORR is working closely with the foster care network
to recruit additional families through local events and outreach
partnerships with non-governmental organizations, refugee resettlement
agencies, and community organizations. ORR also formed a workgroup of
individuals across these organizations that specifically focuses on the
needs of the UC foster care network. Individuals who are interested in
providing foster care to unaccompanied children can visit the ORR
Foster Care webpage to learn more about each program and how to become
a foster parent.
Question. What steps is it taking to meaningfully reach this goal,
knowing that the number of child arrivals varies throughout the year?
Answer. ORR continues to focus on expanding standard bed capacity
as the preferred placement option for children in ORR care. ORR reviews
capacity needs throughout the year, based on historic data and DHS
estimates. ORR considers several factors such as UC referral numbers,
trends, projections, and COVID-19 infection rates and impact on
staffing and bed availability.
By transitioning its two EISs into ICFs, which have equivalent
standards to ORR's licensed facilities, adding beds to existing grants,
and funding new grants for more standard facilities in 2022, ORR is
strategically preparing to address influx capacity needs given the
challenge with predicting with any degree of certainty the number of UC
arrivals and referrals to ORR.
Question. President Biden recently announced that the United States
would be accepting 100,000 Ukrainian refugees. Some unaccompanied
Ukrainian children have already been apprehended at the southern
border. What plans are in place to receive and care for Ukrainian
unaccompanied children?
Answer. For Ukrainian UC who arrive at Ports of Entry (POE), ORR
will follow the established policies and processes to accept referrals
from DHS into its custody and care. Using the UC care provider network,
ORR will base all placement decisions on the best interests of the
child with the goal of placing UC in the least restrictive setting
available per ORR Policy and Procedures, and relevant Field Guidance.
As of April 5, 2022, ORR currently has 12 Ukrainian children in its
care.
Question. How will ORR learn from the Afghan evacuation crisis to
ensure that children and their families are not separated?
Answer. ORR does not play a role in the vetting of family units
overseas, nor does ORR have any role in the separation of children from
adults. However, ORR has been working with its interagency partners,
through ongoing discussions, on the process under which Ukrainian
unaccompanied children may travel to the U.S. As was the case during
the Afghan evacuation, ORR will continue to receive referrals from DHS
for Ukrainian children who arrive without a parent or legal guardian.
Once in ORR custody, care providers provide family unification services
(both domestic and international), educational and recreational
services, health care, mental health services, access to legal
services, access to child advocates, where applicable, and case
management in a culturally and linguistically appropriate manner to
ensure the safety and well-being of the child. During Operation Allies
Welcome (OAW), ORR mobilized case workers, translators, and Federal
field staff to the airports used by OAW and to OAW Safe Havens to
provide sponsor vetting and family unification services onsite for
unaccompanied Afghan minors (UAM). This process allowed Afghan families
to stay together during ORR processing, since many children arrived
with an adult family member who was not their parent or legal guardian.
ORR's continued commitments to preserving the unity of family groups
and to collaborating with interagency partners like the Department of
State (DOS) are central to the work of ORR.
______
Questions Submitted by. Hon. Benjamin L. Cardin
violence intervention programs
Question. I am glad to see the proposed $250 million for the
Centers for Disease Control for the Community Violence Intervention
initiative, in collaboration with Department of Justice, to support
evidence-based community violence interventions at the local level.
Hospital-based interventions are among the most effective within this
category.
By providing services for victims of violent crime while they are
recovering from their injuries, these programs equip survivors to make
lifestyle changes that prevent them from being re-victimized or reduce
their likelihood of being involved in future violence. The program at
the University of Maryland Medical Center's Shock Trauma Center has
demonstrated impressive results. However, there are few Federal
resources available for this work.
I have legislation to create HHS grants for hospital-based violence
intervention or prevention programs. Federal funds would be used to
establish or expand operations and study their effectiveness. Last May,
the House of Representatives passed a companion, introduced by my
colleague from Maryland, Congressman Ruppersberger, with strong
bipartisan support.
As we continue to see a rise in people experiencing behavioral
health challenges, can you discuss the administration's commitment to
the Community Violence Intervention Initiative and the importance of
this program in supporting the mental health needs of survivors of
violent crime?
Answer. Through the Community Violence Intervention Initiative, CDC
would focus on preventing violence from happening in the first place
and reducing the impacts once violence has occurred. The initiative
would also focus upstream on increasing resilience and reducing risk
factors for the development of mental health conditions.
Question. In light of the 2021 GAO report that gun violence costs
hospitals over $1 billion annually, can you comment on the potential
returns on investments in violence intervention programs?
Answer. Hospital-based violence interventions have been shown to
decrease violent reinjuries, high-risk behaviors, violent re-
victimization, and violent arrests. They have also demonstrated cost
savings to the health-care and criminal justice systems, as well as
gains in employment among program participants. The available evidence
suggests that there is the potential for substantial cumulative return
on investment from hospital-based violence interventions Rigorous
evaluation will be an important component of CDC's Community Violence
Intervention Initiative to help us identify the most effective programs
for reducing gun violence and reinjury to provide a more complete
estimate of potential savings.
CDC is currently supporting multiple studies that can help describe
the cost, savings, and return on investment from hospital-based
violence interventions.
prudent layperson enforcement
Question. As you know, the ``prudent layperson standard'' is a
critical patient protection that requires insurers to cover emergency
care based on a patient's symptoms, not on their final diagnosis. I am
deeply concerned by continued attempts to discourage patients from
seeking emergency care that essentially requires them to self-diagnose.
For example, in 2021, UnitedHealthcare proposed and rescinded a policy
that would retroactively limit or deny coverage for emergency room
visits they felt were ``unnecessary.''
Patients should not be expected to determine on the spot whether
their condition is a life or death situation. Cost-cutting measures
such as these lead patients to fear the health-care safety net instead
of seeking it out and could ultimately cost Americans their lives.
Will you commit to working with me to determine if this policy is
compliant with Federal law and, further, to ensure that the prudent
layperson standard is appropriately enforced?
Answer. As we noted in Requirements Related to Surprise Billing,
part 1 (86 FR 36872), we are aware that some plans and issuers
currently deny coverage of certain services provided in the emergency
department of a hospital by determining whether an episode of care
involves an emergency medical condition based solely on final diagnosis
codes. In addition, some plans and issuers might automatically deny
coverage based on a list of final diagnosis codes initially, without
regard to the individual's presenting symptoms or any additional
review. Following an initial denial, plans and issuers might then
provide for complete consideration of the claim, and apply the prudent
layperson standard, only as part of an appeals process if the
participant, beneficiary, or enrollee appeals. These practices are
inconsistent with the emergency services requirements of the Affordable
Care Act. This is true even if the process for complete consideration
of the claim following an initial denial is not designated as a formal
appeal. Instead, the determination of whether the prudent layperson
standard is met must be made on a case-by-case basis before an initial
denial of an emergency services claim. HHS is committed to its
oversight and enforcement of the requirements included in statute and
regulation. HHS looks forward to working with Congress and other
stakeholders to make sure health insurance plans include appropriate
consumer protections.
medically necessary dental care
Question. While oral health is an integral part of overall health
and general well-being, too many Americans are unable to access the
dental care they need to maintain a healthy mouth and body. Millions of
Medicare beneficiaries, particularly people of color and people with
lower incomes, face significant health risks because they do not have
access to medically necessary oral and dental treatment. Far too often,
the lack of such treatment exacerbates beneficiaries' health and, thus,
increases Medicare's costs for treating their illnesses.
As you may know, the Medicare program already provides limited
coverage for medically necessary oral and dental treatment using the
authority HHS already has. Examples include coverage of tooth
extractions to prepare the jaw for cancer radiation treatment and
dental examinations prior to kidney transplant.
In light of the strong support by medical, dental, and patient
advocacy organizations, would you be willing to consider broader use of
your existing authority to expand access, improve outcomes, and reduce
overall costs by covering dental services in additional clinical
contexts in which oral infections and inflammation can delay, prevent,
or compromise important medical treatment?
Answer. Oral health is a critical part of overall health, and the
Biden-Harris administration supports making dental coverage a standard
benefit in Medicare. CMS looks forward to collaborating with Congress
on legislation to expand Medicare beneficiary access to dental care. In
the meantime, we plan to review our existing payment policies related
to the coverage of medically necessary dental care under the Medicare
program in order to determine whether we can expand on these existing
policies under our existing statutory authority.
telehealth and health equity
Question. The COVID-19 pandemic has demonstrated the incredible
benefit of telehealth services. I have been proud to partner on the
CONNECT for Health Act with a number of bipartisan colleagues,
including Finance Committee members Senators Warner and Thune. The
CONNECT for Health Act proposes to make permanent the COVID-19
telehealth flexibilities, and I look forward to working with HHS to
ensure the appropriate telehealth flexibilities are expanded post-
pandemic.
However, Americans face varying levels of access to telehealth
care. A recent HHS study found that as telehealth services expanded
rapidly during the pandemic, utilization varied by race, ethnicity,
income, age, and insurance status. There were significant disparities
among subgroups in terms of audio versus video telehealth use. Video
telehealth rates were lowest among those without a high school diploma,
adults ages 65 and older, and Latino, Asian, and Black individuals. The
report noted that policy efforts to ensure equitable access to
telehealth, in particular video-
enabled telehealth, are needed to ensure that disparities that emerged
during the pandemic do not become permanent.
President Biden's budget includes a variety of investments in
telehealth, including $44.5 million within the Health Resources and
Services Administration (HRSA) to expand telehealth services.
President Biden also supports extending telehealth coverage under
Medicare beyond the COVID-19 public health emergency to study its
impact on utilization of services and access to care. Could you provide
additional details on policies the administration would support in the
expansion of telehealth as well as policies to reduce racial, ethnic,
and geographic disparities in utilization?
How will you work to reduce disparities in telehealth modality
utilization by Medicare, Medicaid, and CHIP enrollees, which have
emerged during the COVID-19 pandemic, particularly communities of
color, older Americans, and low-income individuals?
Answer. During the COVID-19 public health emergency, telehealth has
been a reliable resource allowing providers to reach patients directly
in their homes in order to ensure access to care and continuity of
services. The Biden-Harris administration is committed to supporting a
temporary extension of broader telehealth coverage 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 access to broadband
or technology to support 2-way audio-video, particularly in rural and
underserved areas and among older populations.
The administration is also expanding access to mental health and
beneficiary-
centered care under Medicare via greater use of telehealth and other
telecommunications technologies to provide behavioral health care and
other services. Medicare beneficiaries can receive care directly in
their homes thanks to recent regulations, including CMS's CY 2022
Physician Fee Schedule final rule, that allow for the provision of
certain behavioral health services via audio-only telephone calls.
______
Questions Submitted by Hon. Sherrod Brown
child care access and affordability
Question. Since the onset of the pandemic, the child care industry
has lost nearly one-third of its workforce due to low pay, burnout, and
inadequate benefits for workers.\5\ The limited availability of
affordable and accessible child care options has also put additional
strain on working parents to find care options that best suit their
family needs. And, this issue is exacerbated for families in rural
communities, low-income communities, and communities of color, where
many people work non-
traditional hours with low wages and limited access to affordable
transportation options.
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\5\ Wallace, Alicia (January 2022). America's child care crisis:
Parents struggle as facilities close nationwide due to staffing
shortage. CNN Business, https://www.cnn.com/2022/01/28/economy/child-
care-labor-force-declines/index.html.
Investments in early childhood learning have multiple benefits:
they lay the foundation for children to succeed throughout their
education and later in life; they provide economic opportunities for
child care workers; and they provide flexibility in working parents'
schedules so that they may contribute to local economies. The
President's HHS FY23 budget proposal would provide additional funding
to help solve these care crisis issues by investing in the health and
well-being of our country's future, including $20.2 billion for early
care and education programs within the Administration for Children and
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Families (ACF).
How can additional investments in existing Federal early childhood
education funding streams--like Head Start and the Child Care
Development Block Grant (CCDBG)--be utilized to address the issues that
contribute to the child care workforce shortage, such low wages and
limited benefits packages?
Answer. The Biden-Harris administration is committed to supporting
and growing the early care and education workforce. Unfortunately,
because of the thin operability margins in child care, parents are
paying as much as they can while early care and education workers often
earn low wages and have low access to workplace benefits like health
insurance or paid leave. Head Start programs provide free early
education and other comprehensive services to eligible children from
low-income families, but for decades programs have not had sufficient
funding to raise compensation for their workforce. Adequate
compensation is key to attracting and retaining a skilled workforce for
both child care and Head Start programs.
The FY 2023 President's budget requests $7.5 billion in
discretionary and $3.55 billion in mandatory funds, bringing total
Child Care and Development Fund (CCDF) resources to over $11 billion, a
$1.4-billion increase over FY 2022 enacted levels. These additional
resources are needed to maintain and increase the support provided to
children and families and to raise reimbursement rates for child care
providers. Labor constitutes the majority of expenses in child care,
and with increased subsidy reimbursement rates, child care programs can
provide higher wages and more benefits to staff, which will increase
supply, reduce turnover, and improve child care quality. ACF's Office
of Child Care (OCC) encourages lead agencies to use fixed cost payment
practices, such as paying based on children's enrollment rather than
attendance, which results in providers having more predictable, stable
revenue and to continue to pay workers when children are absent due to
health or other reasons.
The FY 2023 President's budget requests a total of $12.2 billion
for the Head Start program, which is a $1.2-billion increase over the
FY 2022 enacted levels. This budget request includes funding to provide
for a cost-of-living adjustment to allow programs to keep pace with
inflation. Although this does not provide additional funding to improve
staff compensation to be more competitive, this administration has
raised and continues to support the goal of improving the compensation
of Head Start staff to support pay parity with elementary school staff,
for those with similar qualifications.
Question. What resources and materials can HHS provide to States to
facilitate efforts by child-care providers in rural and low-income
areas to access Federal early childhood education funds and thus, best
serve the children and families in their community?
Answer. The Biden-Harris administration supports efforts to ensure
access to Federal child-care funding--both for child-care providers and
children/families--in rural and low-income areas. The FY 2023
President's budget requests an additional $1.4 billion in discretionary
Child Care and Development Fund (CCDF) resources over FY 2022 enacted
levels--over $11 billion total--to increase resources for States,
territories, and Tribes to expand the number of children receiving
child-care subsidies, and to improve the provider payment rates for
those subsidies, which in many jurisdictions are inadequate. In
addition, States, territories, and Tribes would have additional
resources to improve the quality and supply of child care--including in
child care deserts, which often include rural and low-income
communities.
This funding increase would build the administration's ongoing
American Rescue Plan (ARP) implementation work, which provided $24
billion in child care stabilization grants to providers to support the
stability of the child-care sector during and after the COVID-19 public
health emergency. The Office of Child Care (OCC) has instructed States
to target stabilization grants, which can be used for wages and
benefits, among other operational activities, to underserved
constituencies and required States to report on the demographics of
providers receiving grants. As a result, several States used the Center
for Disease Control and Prevention's (CDC) Social Vulnerability Index
(SVI) to support equitable distribution of funds to child-care
providers that serve communities most in need in their States. To make
it easier for providers to access stabilization grants, OCC published a
web page with links to State applications, and provided resources to
assist providers, including hosting national webinars for child-care
providers about the availability of stabilization grants. OCC developed
a resource guide to help family child care business owners complete
child care stabilization grant applications, thus providing application
support to smaller, less-well-resourced providers.
The ARP also provided $15 billion in supplemental CCDF
discretionary funding. In the guidance for this funding, OCC encouraged
States to increase subsidy payment rates to providers and to improve
payment practices that impact the value of the subsidy, such as the use
of grants and contracts (rather than certificates/vouchers). The
guidance noted that grants or contracts provide a more predictable
funding stream for child-care providers and help build the supply of
child care in underserved areas or for underserved populations, such as
infants and toddlers, children in rural areas or low-income
neighborhoods, dual language learners, children with disabilities, and
children who need child care during non-traditional hours.
medicaid coverage of vaccines
Question. Medicaid provides a safety net for our most vulnerable
citizens--low-
income older adults, pregnant and postpartum individuals, and the
disabled to name a few. In Ohio it's estimated that nearly a quarter of
insured Ohioans access health insurance through Medicaid or the
Children's Health Insurance Program.\6\
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\6\ https://www.medicaid.gov/state-overviews/scorecard/percentage-
of-population-enrolled-medicaid-or-chip-state/index.html.
As part of the Affordable Care Act, Congress acted to provide
coverage for vaccines without cost sharing in States that opted to
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expand Medicaid.
While the ACA helped to extend coverage for millions of previously
uninsured Americans and ensure adults can access recommended vaccines
at no out-of-pocket cost, those who remain in traditional Medicaid
continue to live with a patchwork of coverage for preventive care,
including vaccines. That is why I introduced legislation, the Helping
Adults Protect Immunity (HAPI) Act, which would extend the same
coverage of vaccines without cost sharing to all individuals with
Medicaid, regardless of where they live or if they are covered under
traditional Medicaid or the ACA's expansion.
Will you commit to work with me to ensure that all Medicaid
populations have access to potentially lifesaving vaccines without
unnecessary restrictions?
Answer. Preventing disease before it starts is critical to helping
people live longer, healthier lives, and CMS is committed to helping
States undertake efforts to expand access to preventive health care.
As an example, on May 12, 2022, CMS released a letter to States to
provide information on Medicaid and CHIP coverage and payment for
stand-alone vaccine counseling. The letter describes how CMS interprets
the Medicaid Early and Periodic Screening, Diagnostic, and Treatment
(EPSDT) benefit to require States to provide coverage of stand-alone
vaccine counseling to Medicaid beneficiaries under the age of 21 who
are eligible for EPSDT. This interpretation applies to standalone
vaccine counseling related to all vaccines covered for beneficiaries
eligible for EPSDT, including COVID-19 vaccines.
CMS continues to provide guidance and support to State Medicaid and
CHIP agencies to address deeply embedded disparities in accessing
medical services, and the agency looks forward to partnering with
Congress to improve beneficiary access to quality care.
hrsa provider relief fund
Question. The HRSA Provider Relief Fund and specific set aside for
rural hospital relief passed as part of the American Rescue Plan Act
have helped keep hospitals across the country afloat as they've
struggled with the impact of COVID-19. While I appreciate everything
HHS and HRSA has done to help distribute these funds efficiently and
equitably, I remain frustrated by the lack of transparency when it
comes to pending applications.
I have heard from several Ohio hospital CEOs and leadership from
other health-care providers in Ohio who have front-line workers and
systems that have been waiting months for funding or for status updates
on their phase 3 reconsiderations and phase 4 applications. It's
concerning that HRSA--or its contractor(s)--are unable or unwilling to
provide meaningful updates on the status of applications that have been
sitting with the Department for months, or share insight into the
potential timeline for fund distribution moving forward. I understand
that there are millions of applications that HRSA has had to work
through, each one with its own complications. Despite this, it is
important that providers receive timely information so that they can
make the decisions necessary for them to continue to provide quality
care to their communities.
Can you please commit to ensuring casework requests related to the
HRSA provider relief fund and other associated COVID-19 relief measures
are prioritized and receive meaningful responses in a timely manner?
Answer. Yes. HHS and HRSA understand the importance of the Provider
Relief Fund (PRF) for health-care providers working to deliver care in
their communities and will continue to prioritize responding to and
working with applicants to address casework inquiries. About 89 percent
of Phase 4 applications and 97 percent of American Rescue Plan Rural
applications have been processed. Remaining applications are generally
from complex entities that may have multiple taxpayer identification
numbers and subsidiaries, where it is necessary to manually review
detailed filings to ensure that there isn't duplication of payments and
to otherwise ensure program integrity. HHS and HRSA are committed to
timely processing and transparency and will continue to work as
expeditiously as possible to finalize reviews.
active pharmaceutical ingredient supply chain resiliency
Question. Right now, the United States depends on other countries
for a range of pharmaceutical products, including many active
pharmaceutical ingredients (APIs) that are essential to create generic
prescription drugs. Generic drugs make up 90 percent of all
prescriptions filled in the United States, and about 87 percent of API
facilities for generic medicines are located overseas. The pandemic has
revealed gaping holes and vulnerabilities in our supply chains, and the
fact that the U.S. relies almost entirely on a global supply chain for
APIs and essential medicines poses a risk to our health and national
security.
As you know, the essential medicine supply chain and active
pharmaceutical ingredients were identified in President Biden's
February 2021 executive order on American Supply Chains. It's past time
to identify the gaps in this essentials supply chain and build
emergency capacity for essential medicines here in the U.S.--there is
no reason we should be relying on countries like China or India for
nearly 90 percent of these critical pharmaceutical ingredients, when we
have talented scientists and manufacturers right here.
What actions has HHS taken or plan to take to incentivize onshoring
of API production and storage, and domestic manufacturing of these
essential drugs?
Answer. ASPR is supporting a number of activities including:
domestic manufacturing of PPE and active pharmaceutical ingredient
manufacturing capacity; COVID-19 testing, including swabs, tests and
kits, supplies such as reagents and resins; and enhanced vaccine
production capacity. Each of these domestic manufacturing initiatives
meet current, as well as future COVID-19 needs, and seek to create or
sustain high-value domestic jobs.
In addition, 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. As we continue to move this
effort forward and consider expansion, any modification will be
dependent on available resources. I will be happy to keep you and your
staff informed of activities related to this initiative.
HHS is also working to implement the Make PPE in America Act,
included in the Bipartisan Infrastructure Law, to catalyze domestic
investments and make America's health supply chain stronger and more
resilient.
Question. Last year, Senator Cassidy and I introduced the PREPARE
Act, which would create an emergency supply of key ingredients used in
essential generic medicines and incentivize domestic manufacturing of
these ingredients to build a more resilient domestic supply chain for
essential medicines like antibiotics, which are no longer made in the
U.S. Will you commit to working with our offices to ensure we fully
leverage the work already begun by BARDA and ASPR to ensure we have a
secure domestic pipeline available at all times for the medicines
necessary to sustain the health of the U.S. population?
Answer. Yes, I am committed to working with Congress on efforts to
support domestic manufacturing capabilities to enhance our domestic
supply chain. It is critical that we have access to supplies in future
response operations and I look forward to working with you on this
effort.
continuous eligibility for kids
Question. Over the past 2 years, Congress has taken steps to
increase the stability and consistency of coverage for Medicaid and
CHIP enrollees. Early in the COVID-19 pandemic, Congress passed the
Families First Coronavirus Response Act, which included a provision
requiring all States receiving enhanced Medicaid funding to provide
continuous Medicaid coverage to all enrollees throughout the COVID-19
public health emergency. This action helped reduce churn in Medicaid--
usually a serious problem--to a temporary halt--allowing children and
other beneficiaries to rely on continuous coverage throughout the
pandemic even if their family's income varied month-to-month.
Later, Congress passed the American Rescue Plan Act, which gave
States an option to extend continuous coverage to Medicaid and CHIP
pregnant enrollees through one full year after the birth of a child.
Several States have announced their intent to take up this option. The
House-passed Build Back Better Act would have built on this State
option to require States to provide 12-month continuous Medicaid and
CHIP eligibility for children and 12 months of postpartum Medicaid and
CHIP coverage for new moms. Each of these important legislative steps
has helped move the country closer to ensuring stable health-care
coverage for everyone on Medicaid and CHIP.
Are there additional steps the Centers for Medicare and Medicaid
Services (CMS) can take to support these policies, reduce churn in
Medicaid and CHIP, and provide continuous coverage for kids and new
moms?
Could CMS encourage more stable Medicaid and CHIP coverage by
publishing State Health Official letters and prioritizing continuous
eligibility in 1115 demonstrations?
Answer. The Biden-Harris administration is committed to ensuring
that every eligible person can access the coverage and care to which
they are entitled. Federal law provides States with options to
implement a variety of strategies to promote continuity of coverage,
and we are committed to working with States on this important issue. In
guidance CMS released in March 2022, CMS encouraged States to consider
strategies that will help eligible individuals maintain coverage,
prevent churning on and off of coverage, and mitigate procedural
denials based on the absence of a renewal form or other information
needed by the State to complete a redetermination of eligibility. These
strategies include State plan options such as adopting continuous
eligibility for children, adopting 12 months of continuous postpartum
coverage, and Express Lane Eligibility. States can also take steps to
streamline renewals and improve communications and outreach to
beneficiaries. CMS has issued tools to support States in these efforts,
including communications tools to assist in beneficiary outreach.
With respect to continuous postpartum coverage, we are pleased that
seven States and counting have received approval to extend 12 months of
postpartum Medicaid and CHIP coverage to their beneficiaries, and CMS
is now working with at least a dozen States and the District of
Columbia on this important policy.
CMS is also developing a more comprehensive access strategy in the
Medicaid and CHIP programs. In February 2022, CMS issued a Request for
Information (RFI) on access to care and coverage for people enrolled in
Medicaid and CHIP. Feedback obtained from the RFI will aid in CMS's
understanding ofenrollees' barriers to enrolling in and maintaining
coverage and accessing needed health-care services and support through
Medicaid and CHIP.
This year, CMS committed over $49 million in Connecting Kids to
Coverage Outreach and Enrollment Grants to continue efforts to reach
out, enroll, and retain eligible children in Medicaid and CHIP. Funded
organizations will provide enrollment and renewal assistance to
children and their families, as well as pregnant people.
______
Question Submitted by Hon Robert P. Casey, Jr.
transitional coverage for emerging technologies (tcet)
Question. I was pleased to see President Biden's continued
commitment to medical research and innovative applications in the
health-care system, an ongoing commitment to the safety and efficacy of
medical products, in the FY2023 budget. This funding will provide
significant new opportunities for researchers to identify and develop
novel ways to prevent, treat and cure diseases. I am also encouraged
that CMS is working on a new approach, known as Transitional Coverage
for Emerging Technologies, or TCET, to create a clear pathway for
Medicare coverage of safe and innovative medical technology.
What is the administration's timeline for the TCET rule to provide
meaningful predictability and clarity for the Medicare coverage process
for safe and innovative technologies?
Answer. CMS remains committed to expanding access to health-care
coverage and services, including new, innovative treatments when they
are safe and appropriate. CMS rescinded the Medicare Coverage of
Innovative Technology and Definition of ``Reasonable and Necessary''
(MCIT/R&N) final rule because of concerns that the provisions in the
final rule may not have been sufficient to protect Medicare patients.
By rescinding this rule, CMS will take action to better address those
safety concerns in the future.
Improving and modernizing the Medicare coverage process continues
to be a priority, and we remain committed to providing stakeholders
with more transparent and predictable coverage pathways. CMS is working
as quickly as possible to advance multiple coverage process
improvements that provide an appropriate balance of access to new
technologies with necessary patient protections. As part of this
effort, CMS is conducting several listening sessions to learn about
stakeholders' most pressing challenges and to receive feedback from
stakeholders about which coverage process improvements would be most
valuable.
CMS intends to explore coverage process improvements that will
enhance access to innovative and beneficial medical devices in a way
that will better suit the health-care needs of people with Medicare.
This will also help to establish a process in which the Medicare
program covers new technologies on the basis of scientifically sound
clinical evidence, with appropriate health and safety protections in
place for the Medicare population. HHS looks forward to working with
you and hearing your feedback as we move forward with these efforts.
______
Questions Submitted by Hon. Mark R. Warner
medicare diabetes prevention program expanded model
Question. The Diabetes Prevention Program works to improve the
health of those with prediabetes and prevent diabetes, and Medicare
pays for access to this CDC-recognized program through the Medicare
Diabetes Prevention Program Expanded Model. However, despite the
growing prevalence of prediabetes, Medicare only covers in-person
programs, despite significant barriers to access; CDC data showing
Medicare-age participant success in virtual programs; and a recent
recommendation from the National Clinical Care Commission that
``coverage of MDPP be expanded to include virtual delivery.''
During the public health emergency, CMS expanded access to virtual
DPP providers. I have legislation with Senator Tim Scott of South
Carolina, the PREVENT DIABETES Act, which would permanently expand the
program to virtual-only providers.
Does CMS plan to extend this beyond the expiration of the PHE, as
Congress did for other telehealth provisions? You mention in your
budget that HHS supported the extensions Congress made and hope this
includes what you can extend on your end, as well.
Do you support permanently allowing coverage of virtual DPP
providers in Medicare?
Answer. Innovation is important to advancing goals in health care,
and the CMS Innovation Center is integral to the administration's
efforts to promote high-value care and encourage health-care provider
innovation, including virtual and digital health innovation. With
respect to the Medicare Diabetes Prevention Program (MDPP) expanded
model, it is true that CMS issued regulatory flexibilities in response
to the COVID-19 pandemic, including waiving the limit on virtual
sessions that can be provided by MDPP suppliers when in-person classes
are not safe or feasible. MDPP suppliers must remain prepared to resume
delivery of MDPP services in-person to start new cohorts and to serve
beneficiaries who wish to return to in-person services when certain
flexibilities granted during the pandemic are no longer in effect.
home infusion
Question. I led the effort in 2016 when Congress passed legislation
creating a new home infusion benefit in Medicare after I saw the
advances made by other payers to improve care and lower cost by moving
infusion therapy home as much as possible.
However, I've been disappointed that fee-for-service Medicare's
coverage remains not as comprehensive as other payers and even Medicare
Advantage. Payments are just not reflective of the services provided so
there are not enough providers, and recent data published by CMS
acknowledges that utilization of the new benefit has been ``low.''
That's why I am working with my colleague Senator Scott of South
Carolina and we've introduced legislation to improve this important
benefit.
Do you believe that utilization of the new benefit is at least
partially due to too-low payments to providers?
Will you commit to work with me to improve this benefit to ensure
Medicare has as comprehensive a benefit as other payers?
Answer. The Biden-Harris administration supports strengthening home
and
community-based services as an alternative to institutionalized care,
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 such as a nursing home. Home infusion therapy services
can play in important role in allowing beneficiaries to continue
receiving care within their own home instead of a hospital or physician
office. Per the statute, the Medicare home infusion therapy services
benefit covers professional services, including nursing services,
training and education not already provided under the durable medical
equipment (DME) benefit, remote monitoring and monitoring services. The
home infusion therapy services benefit works in tandem with the DME
benefit. DME suppliers are responsible for furnishing the infusion pump
(including training the patient and/or caregiver on how to use the
infusion pump), the drug or biological, and any pharmacy services
associated with furnishing the drug or biological. We note that
patients and/or their caregivers must be able to self-administer home
infusion drugs in order for the pump and drug to be covered under the
DME benefit.
In November 2021, CMS issued the CY 2022 Home Health Prospective
Payment System Rate Update Final Rule (CMS-1747-F). In addition to
updating the geographic adjustment factor used for wage adjustment, the
final rule updated the home infusion therapy services payment rates for
CY 2022 as required by law. The overall economic impact of updating the
payment rates for home infusion therapy services is expected to be an
increase in payments to home infusion therapy suppliers of 5.1 percent.
HHS looks forward to working with Congress and other stakeholders
to improve the critical home health-care services that allow
beneficiaries to remain in their homes and communities.
essential medicines and supply chains
Question. I have been so excited to see the great work done by
BARDA to secure our Nation's essential medicines, many which have seen
shortages even before the pandemic.
BARDA has made a long-term investment in stakeholders in the
Commonwealth of Virginia to create end-to-end manufacturing capacity
for essential medicines, as the supply chain of such medicines was
identified as one of four key supply chains at risk of disruption in
the 100 Day Supply Chain Review.
It has long been clear that the market is different for essential
medicines, that it's geopolitical vulnerable, and that there's a role
for Federal Government support for domestic manufacturing of essential
medicines and their ingredients to protect the health of Americans and
the health security of the United States.
Is there a plan to expand this framework to antibiotics, which have
similar challenges?
Answer. The global pandemic has highlighted the vulnerabilities of
the global supply chain for many products. It is critical that steps be
taken to invest in expansion of domestic manufacturing capacity. As you
are aware, 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. As we continue to move this effort
forward and consider expansion, any modification will be dependent on
available resources. I will be happy to keep you and your staff
informed of activities related to this initiative.
Question. Will you commit to working with me to continue building
on the work and investments already begun by HHS to ensure we have a
secure domestic supply chain at all times for essential medicines?
Answer. Yes, I commit to working with you and your other
congressional colleagues on efforts to support domestic manufacturing
capabilities to enhance our domestic supply chain and access to
essential medicines. It is critical that we have access to supplies in
future response operations and I look forward to working with you on
this effort.
______
Questions Submitted by Hon. Sheldon Whitehouse
covid-19 workforce shortages
Question. I have heard from Rhode Island's providers about the
strain the COVID-19 pandemic has put on the health-care workforce and
providers' finances. Health-care workers are facing unprecedented and
unrelenting levels of stress and burnout, leading to early retirements
that can exacerbate workforce shortages. Hospitals and other facilities
are paying more for labor, while reimbursement from Medicare, Medicaid,
and private insurance stays the same. Nurses have borne the brunt of
these stresses, and hospitals are struggling to fill nursing vacancies.
What authorities and resources does the Department of Health and
Human Services (HHS) need to support providers, including hospitals,
who are facing nursing and other workforce shortages?
Answer. HHS and HRSA are committed to strengthening the health
workforce and connecting skilled health-care providers to communities
in need. The need for a well-trained, quality health workforce that can
address the diversity of communities in which health professionals
practice is greater than ever and HRSA is focused on strengthening the
workforce by training and connecting skilled health-care providers to
communities in need through grants, loan repayment and scholarship
programs and helping to build the health workforce pipeline.
A critical tool in our health workforce efforts is the National
Health Service Corps, which provides scholarships and loan repayment in
return for a commitment to practice in high need communities. Through
additional congressional support in the CARES Act and the American
Rescue Plan (ARP) Act, HRSA was able to expand the reach of this
program and make more awards/fund more individuals than ever before.
Moreover, the CARES Act provided additional flexibilities for NHSC
clinicians who are currently serving in Health Professional Shortage
Areas and whose service obligation was negatively impacted by the
pandemic.
HRSA also funds physician training and nurse training programs as
well as critical programs like nurse faculty programs that aim to grow
the opportunities for more individuals to enter the health professions
by building training programs' capacity to serve students. In addition,
appropriations to HRSA support behavioral health workforce training
programs and the community-based health workforce such as community
health workers. The size and scope of these efforts are contingent on
annual appropriations.
HRSA's continued goal is to ensure patient access to high-quality
care, especially for underserved populations. We look forward to
continuing to work with Congress to strengthen and support our health-
care workforce serving our communities of greatest need.
adult vaccines mandatory coverage proposal
Question. Last fall, HHS reported that Congress could provide all
adults access to all CDC-recommended vaccines without cost sharing.\7\
More recently, the President's Fiscal Year 2023 HHS budget includes a
proposal that would eliminate vaccine cost sharing for older adults
across country.
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\7\ https://aspe.hhs.gov/sites/default/files/2021-09/
Competition%20EO%2045Day%20Drug%20
Pricing%20Report%209-8-2021.pdf.
I introduced S. 912, the Protecting Seniors Through Immunization
Act, with my colleagues Senators Hirono and Tim Scott to provide
Medicare beneficiaries access to all recommended vaccines at no
additional cost. Does the administration support this bipartisan
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legislation?
Answer. The COVID-19 pandemic has emphasized the importance of
vaccines and the critical role they play in preventing severe disease
and saving lives. In addition to proposing investments in the research
and development of vaccines, the President's FY 2023 budget includes
proposals to expand access to vaccines for both children and adults.
Within Medicare, the budget proposes to consolidate all vaccine
coverage under Medicare Part B.
Current Medicare coverage for vaccine administration is divided
between Part B and Part D, which can be confusing and burdensome for
both Medicare beneficiaries and providers. Part B is a more appropriate
type of coverage for vaccines because more beneficiaries are enrolled
in Part B than Part D, and higher out-of-pocket costs in some Part D
plans may create a financial barrier to access. This proposal would
shift all Medicare coverage for vaccines, including administration
costs, to Part B and require that Medicare Advantage Plans charge no
greater cost sharing for any vaccines and their administration than is
charged under Original Medicare. For all vaccines recommended by the
Centers for Disease Control and Prevention's (CDC) Advisory Committee
on Immunization Practices and adopted by the CDC Director, with the
exception of vaccination for travel-related purposes, there will be
zero cost sharing for Medicare beneficiaries. This proposal would also
modify the way Medicare pays for vaccines from 95 percent of the
Average Wholesale Price, which often has little relationship to market
prices, to 103 percent of the Wholesale Acquisition Cost, the price at
which the manufacturer sells the vaccine to the wholesaler. These
changes promote better access to vaccines among the Medicare population
while better aligning Medicare payment with actual costs. Health equity
is improved by removing potential financial barriers to CDC-recommended
vaccines.
Additionally, the budget requests new mandatory resources at CDC to
provide uninsured adults access to recommended vaccines at no-cost.
Modeled after the highly successful Vaccines for Children (VFC)
program, the proposed Vaccines for Adults (VFA) program would build on
the investments made in response to the COVID-19 pandemic and provide a
crucial--and missing--component of the public health infrastructure
toward achieving vaccinations across the life span. CDC has proposed
$2.1B in mandatory funding in FY 2023 and a total of $25 billion over
10 years.
While CDC has authority under section 317(j)(1) of the Public
Health Service Act (42 U.S.C. 247b(j)(1)) to provide grants for
``preventive health service programs to immunize without charge
children, adolescents, and adults against vaccine-
preventable diseases,'' this is an annually appropriated program that
is limited to serving only those as its funding allows. At current
levels, this discretionary funding has been used to vaccinate a small
proportion of the uninsured adult population and facilitates rapid
vaccination response in outbreak settings; however, these efforts
represent a small portion of discretionary immunization activities.
There has been no dedicated program to ensure vaccination of uninsured
adults.
The VFA program will provide uninsured adults access to recommended
routine and outbreak vaccines at no cost. The creation of this new
mandatory program will be a significant step toward filling existing
gaps in vaccine coverage among US adults and provide sustained support
for immunizations from year to year. CDC will also work with
jurisdictions to leverage base immunization funding (``317'') and other
resources to support associated program operations costs, vaccine
confidence and vaccine equity activities, including communications,
partnerships, education, and technical assistance.
______
Questions Submitted by Hon. Elizabeth Warren
drug prices
Question. The Department's Comprehensive Plan for Addressing High
Drug Prices, released in September 2021, stated that HHS will give
petitions for the use of march-in rights and government use rights
``due consideration,'' and will engage other government agencies to
``address barriers to accessing government-funded inventions.''
HHS has received a petition for the use of march-in rights for
enzalutamide, also known by its brand name Xtandi. Will HHS hold a
public hearing on the enzalutamide petition to allow petitioners and
patent-holders to present arguments and accompanying evidence on this
case?
Answer. The NIH, as the funding agency named, is currently
reviewing the information submitted in the 2021 petition per the march-
in provision of the Bayh-Dole Act (35 U.S.C. Sec. 203), implemented by
37 CFR Sec. 401.6, which authorizes the Government to require the
funding recipient or its exclusive licensee to license a federally
funded invention to a responsible applicant or applicants on reasonable
terms, or to grant such a license itself, if the Federal agency
determines that any of the following conditions are met:
Action is necessary because the contractor or assignee has not
taken, or is not expected to take within a reasonable time, effective
steps to achieve practical application of the subject invention in such
field of use;
Action is necessary to alleviate health or safety needs which
are not reasonably satisfied by the contractor, assignee, or their
licensees;
Action is necessary to meet requirements for public use
specified by Federal regulations and such requirements are not
reasonably satisfied by the contractor, assignee, or licensees; or
Action is necessary because the agreement required by section
35 U.S.C. Sec. 204 (regarding a requirement to manufacture in the
United States) has not been obtained or waived or because a licensee of
the exclusive right to use or sell any subject invention in the United
States is in breach of its agreement obtained pursuant to section 204.
If NIH determines there is sufficient information to initiate a
march-in proceeding per the criteria above, regulations permit an
administrative hearing with fact finding, due process, and witnesses.
Question. What tools does HHS intend to use to ``address barriers
to accessing government-funded interventions''? Which other government
agencies has HHS identified as potential partners?
Answer. There are several strategies by which HHS works to promote
commercialization of inventions with ties to investments in basic
research. For example, NIH's Small business Education and
Entrepreneurial Development (SEED) program aims to accelerate the
conversion of scientific discoveries into impactful health-care
solutions.\8\ Technology transfer programs, governed by the Bayh-Dole
Act and the Federal Technology Transfer Act, guide the transfer of
innovative technologies to the private sector for commercialization and
ultimately public benefit.
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\8\ https://grants.nih.gov/aboutoer/oer_offices/seed.htm.
NIH also works to promote broad access and adoption of inventions
funded with taxpayer dollars. For instance, under a new initiative, NIH
licensed early-stage technologies from the NIH Intramural Research
Program to WHO's COVID-19 Technology Access Pool (C-TAP) for greater
access to companies developing products for use in Low- and Middle-
Income Countries (LMIC).
vaccine supply
Question. The importance of increasing the global COVID-19 vaccine
supply remains urgent. In many low-income countries, less than 20
percent of the population has received at least one vaccine dose,
compared with 80 percent in many middle-and high-income countries. As
White House Coronavirus Response Coordinator Jeff Zients recently said,
``This virus knows no borders, and it's in our national interest to
vaccinate the world and protect against possible new variants.'' On
January 13, 2022, I sent a letter to the Biden administration
requesting that the administration (1) invoke the Defense Production
Act to facilitate mRNA vaccine technology transfer, and (2) prioritize
contracts for government-owned and contractor-operated manufacturing
models when establishing new domestic mRNA manufacturing capacity.
Does the administration plan to invoke its authorities under the
Defense Production Act to facilitate the transfer of mRNA vaccine
technology? If so, when and how? If not, why not?
Answer. HHS works with vaccine manufacturers and with our
colleagues at the White House and other agencies on vaccine production.
However, at this time, there are no plans to utilize Defense Production
Act (DPA) authorities related to the transfer of mRNA vaccine
technology.
One authority under DPA allows Federal agencies to require
companies to prioritize government contracts for medical supplies to
address national emergencies. Each request is specific to an individual
component and priority rating is only used to support critical response
needs; every priority rating has an impact on the medical supply chain
and other medical manufacturers so we make every attempt to minimize
that impact prior to rating any contract or product. To date, HHS has
issued 71 approvals for priority rating under the DPA title I
authorities.
Question. Has the administration considered using public,
government-owned, contractor-operated manufacturing models to fulfill
its November 2021 commitment to drastically expand domestic COVID-19
vaccine manufacturing? If so, what is the status of the
administration's vaccine manufacturing initiative? If not, why not?
Answer. BARDA within HHS has examined and recommended against a
Government-Owned, Contractor-Operated (GOCO) model to fulfill efforts
to expand COVID-19 vaccine manufacturing at this time. GOCO is
effective when the needs of the government cannot be met by the market,
such as nuclear weapons or military ammunition but not necessarily
vaccine manufacturing where the commercial market is well established.
A GOCO vaccine manufacturer would essentially be a Contract
Manufacturing Organization (CMO), able to manufacture products on
demand, rather than being dedicated to one particular product. There is
a robust, and expanding, domestic CMO market already. It is ASPR/
BARDA's goal to build upon that strength to bolster pandemic
preparedness.
The administration has taken significant steps to invest in
expansion of domestic vaccine manufacturing capabilities. Under the
CARES Act of 2020 and the American Rescue Plan Act of 2021, BARDA is
executing an Industrial Base Expansion (IBx) program. One of the most
important advantages of IBx over GOCO is sustainment. Emphasis on
leveraging existing planned capacity expansion is to gain from
industry's perspective on market growth and to mitigate reliance on USG
sustainment.
Question. What resources does the administration have available to
support a public, government-owned, contractor-operated manufacturing
facility capable of meeting its stated target of producing 1 billion
additional mRNA vaccine doses per year? Given the constant threat of
new variants and the increased importance of mRNA vaccines, what
additional resources would be required to scale this plan to produce
billions more doses per year?
Answer. As highlighted in response to question 85, BARDA examined
and recommended against a Government-Owned, Contractor-Operated (GOCO)
model to fulfill efforts to expand COVID-19 vaccine manufacturing.
Instead, the administration has taken significant steps to invest in
expansion of domestic vaccine manufacturing capabilities. Under the
Cares Act of 2020 and the American Rescue Plan Act of 2021, BARDA is
executing an Industrial Base Expansion (IBx) program. The goals of the
IBx plan are multifaceted and address all of the identified needs for a
robust domestic vaccine manufacturing capability to manufacture one
billion doses per year.
These include:
Expand domestic manufacturing capabilities to mitigate
pandemic surge demand and bottlenecks.
Invest in products and services that support existing supply
chain offering high volume manufacturing capacity for COVID-19 vaccines
(large and small businesses).
Establish diverse and robust program portfolios to support at
least 100 million doses/month.
Require industry cost share by capitalizing on existing
industry partner expansion plans.
Focus on efforts that can be operationalized within 3 years of
award.
No government sustainment of capability--rely on industry
perspective in their relevant markets.
Seek Industrial Base Expansion investment consideration from
industry for future product/service contracts during declared public
health emergency for period of 10 years following completion of
capacity expansion.
Preferred pricing.
Priority Access without Defense Product Act.
The IBx program addresses all levels of the vaccine manufacturing
ecosystem and assures sustainability and pandemic preparedness through
strengthening the market, not creating a competitive government-owned
system.
Question. What support is the administration providing to the World
Health Organization's mRNA vaccine technology transfer hub to expand
the availability of mRNA vaccines in low-and middle-income countries?
Answer. The United States Government is committed to accelerating
progress toward widespread and equitable access to safe and effective
COVID-19 vaccines. The administration continues to work with other
countries and organizations including pharmaceutical companies to
accelerate manufacturing, increase vaccine donations, and strengthen
the supply chain. The United States called on countries, vaccine
manufacturers, and other partners to expand global and regional
production of mRNA, viral vector, and/or protein subunit COVID-19
vaccines for low- and lower-middle-income countries and to enhance
transparency of data on production, availability, and projections for
dose manufacturing. We support increasing local manufacturing vaccine
capacity in low- and middle-income countries, including through
technology transfer hubs in various regions, such as the newly
established mRNA hubs in South Africa, Brazil, and Argentina, and HHS
has had conversations with the World Health Organization regarding
their mRNA vaccine manufacturing hub strategy. We remain committed to
trying to strike a balance between ensuring that those who need access
to vaccines get them and continuing to foster innovation in this field.
decriminalizing cannabis
Question. While Congress works to pass comprehensive cannabis
reform, the Biden administration can act now to decriminalize cannabis.
Taking this step would allow States to regulate cannabis as they see
fit, begin to remedy the harm caused by decades of racial disparities
in enforcement of cannabis laws, and facilitate valuable medical
research. On October 6, 2021, I sent a letter to the Department of
Justice requesting that the Attorney General use his authority to
initiate proceedings to determine whether to deschedule cannabis as a
controlled substance. However, the Controlled Substances Act also
States that the Attorney General may initiate these proceedings ``at
the request of the Secretary'' of HHS. Importantly, if the process is
commenced, the Secretary will conduct a scientific and medical
evaluation and offer his recommendation to the Attorney General as to
whether the drug should be controlled or removed as controlled.
Does HHS plan to invoke its authorities under the Controlled
Substances Act to request that the Attorney General initiate
proceedings to evaluate whether to remove cannabis from the schedules
of covered drugs? If so, when and how? If not, why not?
Answer. FDA is aware of the interest in a regulatory pathway for
products derived from cannabis. FDA has identified a need for
additional toxicity and safety data in order to set cannabis product
standards that appropriately protect public health. FDA has taken
additional actions to encourage the development of this information,
specifically issuing a draft Clinical Research Guidance related to the
development of drugs containing cannabis or cannabis-derived compounds,
as well as the Cannabis-Derived Products Data Acceleration Plan, which
outlines initiatives focused on advancing data-driven safety signal
detection and building advanced technology capabilities. FDA is also
examining an AHRQ-authored living systematic review on cannabis and
other plant-based treatments for chronic pain. The evaluation of this
data is ongoing.
Question. What resources does HHS need in order to conduct such a
scientific and medical evaluation of cannabis? How long would such an
evaluation take to complete?
Answer. FDA estimates that the resources and time would be
considerable and would likely exceed what was done for the most recent
evaluation of cannabis, completed in 2015 to respond to two
rescheduling petitions at the time (see documents from public dockets:
https://www.regulations.gov/document/DEA-2016-0011-0001 and https://
www.regulations.gov/document/DEA-2016-0012-0001).
FDA is unable to provide a time frame for completion of such an
evaluation if one were to take place. The following activities would
need to be completed before any evaluation could be finalized. FDA's
Center for Drug Evaluation and Research (CDER) Office of Surveillance
and Epidemiology would need to complete a comprehensive evaluation for
updated understanding of current epidemiology data. The Controlled
Substance Staff (CSS) in CDER would need to conduct a new literature
review and analysis of available clinical data and draw conclusions as
to whether there is now sufficient evidence that would constitute a
currently accepted medical use of botanical forms of cannabis, based on
published data and results from large, adequate, well-controlled
clinical trials. Additionally, CSS would need to update all other
categories of data under the eight factors required to be analyzed in
evaluating the scheduling of controlled substances and would require
review, discussion, and clearance of the evaluation with: FDA/CDER
senior management, NIDA staff and senior management, staff within the
FDA's Office of Chief Counsel and Office of the Commissioner, and HHS'
Office of the Assistant Secretary for Health. We also recommend
discussion with DEA for their own estimates of considerable staff
resources from their agency, and the Department of Justice broadly, to
prepare updated findings, based on HHS input, and a Federal Register
notice on this subject.
Question. Since January 1, 2010, for which drugs has HHS conducted
a scientific and medical evaluation under 21 U.S.C. 811(b)? How long
did such evaluations (if any) take to complete?
Answer. Since 2010, FDA has conducted and provided to HHS a total
of 130 eight-factor analyses, including recommendations regarding
scheduling as appropriate. Each analysis requires the review of a
substantial body of data, and the specifics of each analysis differ
substantially depending on whether those data are readily available as
well as the quality of the data and any additional work FDA has to
perform to complete the scientific evaluation. Given that, no single
estimate can be provided as to how long the evaluations take.
medicare advantage
Question. The President's FY 2023 budget acknowledges that
``payments to [Medicare Advantage] plans are 104 percent of what they
would be to provide Part A and B benefits in fee-for-service,
negatively affecting Part A solvency and increasing Part B premiums for
beneficiaries.''
What factors has HHS determined are contributing to overpayments to
Medicare Advantage plans? What strategies is HHS exploring to limit
these overpayments?
Answer. Contract-level Risk Adjustment Data Validation (RADV)
audits are CMS's primary corrective action to recoup Medicare Advantage
(MA) overpayments. RADV uses medical record review to verify the
accuracy of enrollee diagnoses submitted by MA organizations for risk-
adjusted payment. In April of 2022, CMS issued a Health Plan Management
System (HPMS) memo on Data Accuracy to MA organizations reminding
organizations of their obligation to submit accurate risk adjustment
data to CMS. Moreover, CMS maintains that payment recovery will have a
sentinel effect on risk adjustment data quality submitted by plans for
payment because contract-level RADV audits increase the incentive for
MA organizations to initially submit valid and accurate diagnosis
information. In FY 2021, HHS has several RADV audits in progress. HHS
completed the payment year (PY) 2014 RADV audit medical record review
phase and the PY 2015 RADV audit medical record submission phase.
CMS is reviewing MA payment policies. In the Calendar Year 2023
Medicare Advantage and Part D Advance Notice, released in February, CMS
solicited comments on whether enhancements can be made to the MA risk
adjustment model to address the impacts of social determinants of
health on beneficiary health status. CMS also continually reviews MA
coding patterns and continues to assess how we calculate the MA coding
pattern adjustment, how best to apply it, and what the appropriate
level of the adjustment should be. CMS received a number of
recommendations from stakeholders regarding approaches to estimate the
MA coding pattern adjustment. CMS will consider the comments and
recommendations received for future policymaking.
aco realizing equity, access, and community health (reach) model
Question. In February, the Centers for Medicare and Medicaid
Services (CMS) announced a redesign of the Global and Professional
Direct Contracting (GPDC) Model in response to concerns about
introducing privatization into traditional Medicare. Until the new ACO
REACH Model takes effect in January 2023, CMS has said that it will
conduct ``more robust and real-time monitoring of quality and costs''
of GPDC Model participants and that participants may face ``potential
termination from the model'' if they do not meet model requirements.
Please describe the changes to GPDC Model oversight that CMS has
instituted to ensure more robust and real-time monitoring of
participants. What information is CMS collecting from program
participants, and how often is CMS reviewing these data?
Please describe the findings from CMS's oversight efforts. Has CMS
discovered any violations of GPDC Model requirements? If so, how many
violations has CMS uncovered and what corrective actions has CMS
initiated? Under what circumstances will CMS terminate a participant
from the GPDC Model before December 31, 2022?
Under the new ACO REACH Model, CMS did not announce any limits to
the number of participants or aligned beneficiaries, creating a risk
that the size of the Model could grow well beyond what is required for
a demonstration. In its Request for Applications, CMS states that it
``may choose to limit the total number of accepted applications''
depending on the volume of applications received. Has CMS identified a
target number of participants or beneficiaries for the ACO REACH Model?
If so, what is it? What criteria has CMS used to inform this limit?
Answer. CMS announced a redesigned Accountable Care Organization
(ACO) model that better reflects the agency's vision of creating a
health system that achieves equitable outcomes through high quality,
affordable, person-centered care. The ACO Realizing Equity, Access, and
Community Health (REACH) Model, a redesign of the Global and
Professional Direct Contracting (GPDC) Model, addresses stakeholder
feedback, participant experience, and administration priorities,
including CMS's commitment to advancing health equity.
The ACO REACH model promotes health equity and focuses on bringing
the benefits of accountable care to Medicare beneficiaries in
underserved communities. The Model includes policies to ensure doctors
and other health-care providers continue to play a primary role in
accountable care. At least 75 percent of each ACO's governing body
generally must be held by participating providers or their designated
representatives, compared to 25 percent during the previous Model. The
new cohort will begin participation in the ACO REACH Model on January
1, 2023. Current Model participants must maintain a strong compliance
record and agree to meet all the ACO REACH Model requirements by
January 1, 2023 to continue participating in the ACO REACH Model. CMS
will also ask for additional information on applicants' ownership,
leadership, and governing board to gain better visibility into
ownership interests and affiliations to ensure participants' interests
align with CMS's vision.
over-the-counter hearing aids
Question. In October 2021, FDA issued its proposed rule ``Medical
Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter
Hearing Aids'' to implement my Over-the-Counter Hearing Aid Act, which
was signed into law in 2017. The public comment period for the rule
ended on January 18, 2022, and the authorizing statute requires a final
rule to be issued no later than 180 days after this date.
Is FDA on track to meet this statutory deadline? Will you commit to
making the issuance of a final rule establishing over-the-counter
hearing aids a priority?
Answer. FDA remains committed to establishing a science-based
regulatory category for over-the-counter (OTC) hearing aids that
assures safety and effectiveness while promoting access to devices that
will help address a significant public health need. Issuing the final
rule to establish a new category of OTC hearing aids is a priority for
the agency. Please see FDA's hearing aid website for more information:
https://www.fda.gov/medical-devices/consumer-products/hearing-aids.
nursing home quality
Question. In February 2022, the White House announced several new
CMS initiatives to improve quality of care in nursing homes, including
(1) establishing new national staffing standards for nursing homes; (2)
enhancing accountability and oversight of nursing homes; and (3)
increasing transparency of nursing home ownership and finances.
In March 2022, CMS announced that it would issue a proposed rule to
establish new staffing standards within 1 year. Please provide a
detailed timeline of the steps that CMS will take to meet this goal.
To the extent that CMS is conducting new studies of nursing home
staffing needs, will the Department guarantee that the individuals
involved in conducting and analyzing such studies are free of conflicts
of interest or connections to the nursing home industry?
Answer. In April 2022, CMS issued its Fiscal Year (FY) 2023 Skilled
Nursing Facilities Prospective Payment System (SNF PPS) proposed rule
(CMS-1765-P), which includes asking for public feedback on how staffing
in nursing homes and health equity improvements could lead to better
health outcomes. In the proposed rule CMS solicits input to help the
agency establish minimum staffing requirements that nursing homes will
need to meet to ensure all residents are provided safe, high-quality
care, and to ensure nursing home workers have the support they need.
This input will be used in conjunction with a new research study being
conducted by CMS to determine the optimal level and type of nursing
home staffing needs. The agency intends to issue proposed rules on a
minimum staffing level requirement for nursing homes within 1 year. The
proposal also requests stakeholder input on a measure that would
examine staff turnover levels in nursing homes for possible inclusion
in CMS's Skilled Nursing Facility Value-Based Purchasing Program, which
rewards facilities with incentive payments based on the quality of care
they provide to people with Medicare.
The proposed rule would build on CMS's ongoing efforts to improve
nursing home staffing and transparency. In January 2022, CMS began
posting staff turnover rates and weekend staff levels for nursing homes
on the on the Medicare.gov Care Compare website. Specifically, the new
information provides the percent of nursing staff and number of
administrators that have stopped working at the nursing home over a 12-
month period and the level of total nursing and registered nurse
staffing on weekends provided by each nursing home over a quarter.
Having access to this information will help consumers understand more
about each facility's staffing environment and choose a facility that
provides the highest quality of care that best meets their health-care
needs. Staff turnover data also helps providers to improve the quality
of care and services they deliver to residents. This information will
allow consumers the ability to review nursing homes' measures relative
to other nursing homes and will also be included in the Nursing Home
Five Star Quality Rating System in July 2022.
Question. According to the White House announcement, ``CMS will
implement Affordable Care Act requirements regarding transparency in
corporate ownership of nursing homes, including by collecting and
publicly reporting more robust corporate ownership and operating
data.'' This requirement is more than a decade old and has not yet been
implemented. What is CMS's timeline for doing so?
What, if any, additional statutory authority does HHS need to
ensure that the Department can properly track the ownership of nursing
homes by private equity firms and Real Estate Investment Trusts (REITs)
and that these private equity and REIT owners are meeting the needs of
the residents under their care?
Answer. Ownership information for currently active nursing homes
enrolled in Medicare is available at: https://data.cms.gov/provider-
data/dataset/y2hd-n93e. This includes detailed information about
individuals and organizations that have direct or indirect ownership
of, a partnership interest in, and/or managing control of the nursing
homes.
In April 2022, HHS announced new actions to promote competition and
transparency in our Nation's health-care system that can improve the
safety and quality of nursing homes and hospitals. For the first time,
CMS publicly released data on mergers, acquisitions, consolidations,
and changes of ownership from 2016-2022 for hospitals and nursing homes
enrolled in Medicare. This data, available on data.cms.gov,\9\ is a
powerful new tool for researchers, State and Federal enforcement
agencies, and the public to better understand the impacts of
consolidation on health-care prices and quality of care. CMS expects to
release updated change of ownership data on a quarterly basis. The CMS
data will enhance transparency for hospitals and nursing homes
patients, potential patients and their loved ones, as well as for
policymakers and the communities where these facilities are located.
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\9\ https://data.cms.gov/provider-characteristics/hospitals-and-
other-facilities/hospital-change-of-ownership; https://data.cms.gov/
provider-characteristics/hospitals-and-other-facilities/skilled-
nursing-facility-change-of-ownership.
Question. The President's FY 2023 budget includes nearly $500
million in funding, a 25-percent increase, to support health and safety
inspections in nursing homes. How will these funds be used? What will
be the impact on nursing home quality if Congress does not provide
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these funds?
Answer. The budget requests $494 million for Survey and
Certification, an increase of $97 million, or 24 percent, above FY 2022
enacted. This investment will strengthen health, quality, and safety
oversight for approximately 67,000 participating Medicare or Medicaid
provider facilities. Survey workloads and costs continue to increase
due to factors such as a growing number of beneficiaries and surveyor
wage growth, as well as an increase in serious complaints against
facilities, which can lead to costly ongoing enforcement activities
once a deficiency is identified. The COVID-19 pandemic has underscored
the Survey and Certification program's critical oversight role for
holding nursing homes and other facilities accountable to meet minimum
infection control standards and protect public health for beneficiaries
in these facilities from COVID-19.
The Coronavirus Aid, Relief, and Economic Security Act provided a
minimum of $100 million to Medicare Survey and Certification for
infection control efforts prioritizing nursing homes. This supplemental
funding helped State Survey Agencies conduct focused infection control
surveys and respond to the backlog of high-level complaint survey
results, recertifications, and other survey activities. Building on
lessons learned during the COVID-19 pandemic, the budget invests in
improving care in long-term care facilities and improving oversight of
accrediting organizations. At the FY 2023 request level, CMS projects
that States would have the resources to fully complete surveys for all
provider types, including complaint surveys, statutorily required
surveys, and non-statutory surveys. This level of survey completion,
which has not been projected since the submission of the FY 2017
President's budget, would permit the program to provide oversight for
the relevant facility types and is the first step in shifting from a
reactive to proactive posture. Timely certification surveys help to
promote quality and avoid preventable patient safety adverse event
issues, avoid patient harm, and may result in less severe enforcement
action over time if issues can be detected earlier and corrected with
education and training, rather than reactively responding to
complaints. Furthermore, CMS will improve oversight of nursing
facilities, including an overhaul of the special focus facility program
to improve care more quickly for low-performing nursing homes. These
changes will make the special focus facility program requirements
tougher and more impactful.
Approximately 93 percent of requests for Medicare Survey and
Certification are performed by State survey agencies. Surveys can
include mandated Federal inspections of long-term care facilities
(i.e., nursing homes), home health agencies, and hospices, as well as
Federal inspections of hospitals and other key facilities that occur on
a non-mandated frequency interval. All facilities participating in the
Medicare and Medicaid programs must undergo certification when entering
the program and on a regular basis thereafter, which generally includes
an onsite survey. The budget will enable CMS to significantly improve
survey frequency levels where there is not a statutorily-required
frequency, potentially preventing serious violations of safety
standards and avoiding patient harm. In total, States will complete
over 30,000 initial surveys and recertifications in FY 2023.
______
Questions Submitted by Hon. Chuck Grassley
rural hospitals and telehealth
Question. I've fought to protect rural health-care access. This
includes most recently protecting rural health care clinic payments,
reauthorizing the rural community hospital demonstration, and creating
the voluntary Rural Emergency Hospital program. I'm also a strong
supporter of making telehealth permanent--this is important to
maintaining access to rural health care. The Trump and Biden
administrations allowed critical access hospitals to bill for
telehealth during COVID-19 pandemic.
Does the administration have a position on extending telehealth
flexibilities for critical access hospitals following the end of the
public health emergency?
Answer. During the COVID-19 public health emergency, telehealth has
been a reliable resource allowing providers to reach patients directly
in their homes in order to ensure access to care and continuity of
services. The Biden-Harris administration is committed to supporting a
temporary extension of broader telehealth coverage 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.
CMS's goal is to develop programs and policies that ensure rural
Americans have access to high-quality care, support rural providers and
not disadvantage them, address the unique economics of providing health
care in rural America, and reduce unnecessary burdens in a stretched
system to advance our commitment to improving health outcomes for
Americans living in rural areas.
public health emergency
Question. In January 2021, HHS wrote to Governors communicating
they will provide States with a 60 days' notice prior to termination of
the public health emergency.
Is HHS still committed to that 60-day notice?
Answer. Yes.
cy 2023 nonenforcement bulletin
Question. On March 23, 2022, CMS extended the non-enforcement
bulletin (https://www.cms.gov/files/document/extension-limited-non-
enforcement-policy-through-calendar-year-2023-and-later-benefit-
years.pdf). I want to thank CMS for allowing transitional health
insurance plans to be sold in calendar year (CY) 2023. This is
something I urged the administration to do. Your action will allow
65,000 Iowans to keep the insurance they like. They are farmers and
small businesses, and chosen to keep the health insurance they
purchased between 2010-2013. This was a bipartisan policy started under
the Obama administration. I'm glad the Biden administration has
maintained this bipartisan policy. The March 23rd bulletin permitted
the non-enforcement policy for CY 2023 and it states the non-
enforcement ``will remain in effect until CMS announces that all such
coverage must come into compliance with the specified requirements.''
While the non-enforcement creates regulatory certainty, especially in
CY 2023, it actually creates uncertainty for 65,000 Iowans after CY
2023 (i.e., CY 2024 and after).
What standard will CMS apply in taking regulatory action to permit
transitional health plans to be sold in CY 2024 and into the future?
What policymaking process will CMS have in taking regulatory action
to permit transitional health plans to be sold in CY 2024 and into the
future?
Answer. On March 23, 2022, CMS issued a bulletin that extends the
policy under which CMS will not take enforcement action against certain
non-grandfathered health insurance coverage in the individual and small
group market that is out of compliance with certain specified market
reforms. The extended non-enforcement policy applies for policy years
beginning after October 1, 2022, and will remain in effect until CMS
announces that all such coverage must come into compliance with the
specified requirements.
rural emergency hospital (reh) voluntary medicare payment designation
Question. Access to emergency and primary health-care services is a
basic quality of life issue for a resident of any sized community.
Section 125 of Public Law (Pub. L. 116-260) established the Rural
Emergency Hospital (REH) voluntary Medicare payment designation. This
bipartisan solution will support struggling rural hospitals by allowing
them to voluntarily right-size their health-care infrastructure while
maintaining essential medical services for their rural communities. I
appreciate CMS issuing a request-for-information (RFI) to implement
REH.
What is the status of issuing the proposed regulation(s) for REH?
Will the proposed regulation(s) be included in the upcoming CY 2023
Medicare payment policy proposed regulations or as a stand-alone
regulation?
Answer. Section 125 of Division CC of the Consolidated
Appropriations Act (CAA) of 2021 provides for Medicare payment for
items and services furnished by REHs on or after January 1, 2023, and
CMS continues to work diligently to ensure that this provision of the
CAA is implemented by this date. REHs will offer the opportunity for
current Critical Access Hospitals and rural hospitals with fewer than
50 beds to seek REH designation. In accordance with the CAA, REHs are
required to furnish emergency services and observation care, and they
may elect to provide additional specified medical and health services
on an outpatient basis, as well as skilled nursing facility (SNF)
services in a distinct part SNF.
By providing these services, rural communities will maintain access
to health care that otherwise may not be available. CMS remains
steadfast in its commitment to rural communities' access to health-care
services and is focused on implementing the REH provision of the CAA
through rulemaking by January 1, 2023.
administration for children and families grant programs
Question. The budget request for the Administration for Children
and Families calls for $100 million dollars in grants for the purpose
of addressing racial inequities in child welfare, and reducing
overrepresentation of children and families of minority heritage. These
grants would be awarded to child welfare agencies and community
partners to develop and implement new strategies in line with these
goals. Some of the suggested purposes include referral lines,
supportive services, and race-blind decision-making practices, among
others. The budget request also calls for $2 million for training for
the child welfare workforce related to anti-racist practices,
increasing hiring and retention of a diverse workforce, and training on
how to use data to analyze workforce for inequities.
Some of the proposed uses for the grant funding, in particular
race-blind removals, have not been shown to actually reduce the share
of children in color in foster care. The implementation of race-blind
removals in Nassau County, NY saw the share of racial minorities in
foster care fluctuate, and child welfare professionals have raised
concerns that this practice overrides professional expertise and
hinders their ability to fully evaluate a family and their situation.
Other anti-racist training programs, such as those based on implicit
associations and implicit biases, have not been shown to impact
behavior of recipients of the training.
If this grant program were to be funded, what evaluation metrics
would be in place to ensure that funds are used on practices that have
been demonstrated to lead to real improvements in the number of
children of color able to safely remain in their homes?
Answer. Child welfare systems need case-level strategies and
community-
supported interventions to reduce racial disparities in removal
decisions and disproportionality in foster care systems. Evaluation
metrics will assess the development and training on case-practice and
decision-making processes that reduce racial bias and increase racial
equity. Additionally, we recognize it is critical to create
collaborative community partnerships to develop systems of care that
impact racial disparity within the larger community. ACF has a wealth
of experience with evaluating systems of care grants to demonstrate
which practices and partnerships that lead to real improvements. The
grant program envisions a continuous improvement cycle involving both
the child welfare agencies and the relevant stakeholders to routinely
come together and evaluate their strategies. ACF expects that grantees
would choose a variety of different strategies and the services
identified above are meant to be illustrative and not exhaustive. ACF
also expects that evaluation would be a critical component of these
grants.
While our understanding of effective approaches to reducing
overrepresentation is evolving, we will continue to rely on the Child
and Family Services Review (CFSR) data/process to understand variation
in outcomes and drive policy and practice change. This includes
supplementing the data we collect so that we can understand differences
in the experiences of children by race/ethnicity. The Child and Family
Services Reviews (CFSRs) are designed to determine States' compliance
with titles IV-B and IV-E of the Social Security Act, and to evaluate
child welfare system performance and require States to make improvement
in outcomes for children and families.
To create a system that is effective and equitable for all, we must
pay particular attention to the experiences of those who may be
marginalized and more likely to have disparate outcomes. Applying an
equity lens in the CFSR and beyond--from the statewide assessment to
the Program Improvement Plan-- is essential to accurately assessing,
identifying, and addressing system-wide improvement needs. During Round
4 of the CFSR, there will be a focus on using data and evidence to
identify disparities in services and outcomes; understand the role that
child welfare programs, policies, and practices may play in
contributing to those disparities; and inform and develop systemic
improvements.
As we continue to be innovative and even bold in trying to identify
interventions that will address bias that we observe in child welfare
outcomes and decision-
making, that we want to be sure to subject such interventions to
scrutiny. The CFSR is one such method for ascertaining the impact of
new programs/processes/interventions introduced into State/local/Tribal
child welfare systems. Another important method is to persistently
partner with researchers and evaluators to help develop, implement, and
rigorously evaluate the impact of such innovations. Finally, we
regularly consult children, youth, adults with lived experience and
expertise so that their perspective are reflect in program and planning
decisions. We will prioritize these partnerships as we seek to further
develop the evidence base.
john h. chafee program for independent living
Question. The budget request calls for a permanent increase in
funding for the John H. Chafee Program for Independent Living, as well
as making permanent the COVID-era flexibilities that allowed States to
serve youth up to age 27, eliminate the cap for housing expenses,
making driving and transportation an allowable expense, and expanding
the eligible population for these services to include youth who
experienced foster care after the age of 14.
For each of the individual program changes listed, does ACF have
data or evidence to suggest that there are better outcomes for youth
who receive services under this program with the flexibilities in
place?
Answer. The request to increase funding and make permanent
flexibilities that were allowed in the Supporting Foster Youth and
Families through the Pandemic Act (Division X of the Consolidated
Appropriations Act, 2021) was informed by input from States
administering the Chafee program and from engagement with young people
with lived experience in foster care. Data from the National Youth in
Transition Database (NYTD) also provides insights relevant to the
request. We also expect to learn more about the use and impact of the
Chafee funding provided by Division X in upcoming narrative reports on
the use of funding that will be provided in the Annual Progress and
Services Reports due June 30, 2022.
From our conversations with agency representatives and young
people, we know that many young adults formerly in foster care struggle
to navigate the existing patchwork of services and eligibility
requirements available through other programs. While many young people
in early adulthood may be able to receive emergency financial support
from a family member, young people formerly in foster care often do not
have this option. The additional funding and flexibilities provided
through Division X allowed States to provide direct assistance to young
people at a time of great need, enabling them to assist young people
who had lost a job, were food insecure, were at risk of losing housing,
needed money to pay utilities or needed to make car repairs to be able
to continue to access employment and other community resources in areas
with limited or no public transportation.
Research and data consistently show that young people leaving
foster care often struggle and that being connected to the foster care
system and/or after-care supports leads to better outcomes. For
instance, the National Youth in Transition Database survey data shows
that 30 percent of the young people who responded to the NYTD survey
and who were not in foster care reported that they had experienced
homelessness within the previous 2 years. However, 19- and 21-year-olds
who remained supported in foster care fared better overall and reported
fewer challenging outcomes than their counterparts who had exited care.
They were half as likely to have been homeless at some point within the
previous 2 years and more likely to be attending school or be employed.
They were less likely to report having been incarcerated or having been
involved with substance abuse; and were less likely to have given birth
to or fathered a child. We expect that providing increased funding and
flexibilities through the Chafee program will similarly support
improved outcomes as young people transition to young adulthood.
The proposal also includes elements to address specific concerns
that have been raised to ACF in the past. Currently, only youth who
exited foster care to adoption or guardianship at age 16 or older may
receive Chafee funded benefits which can create the unintended
consequence of pitting permanency against post-foster care benefits.
The proposal addresses this concern by making young people who are
adopted or exit foster care to legal guardianship at age 14 eligible to
receive Chafee benefits, on the same basis as other youth who
experienced foster care at age 14 or older.
The proposal also includes a provision to make young people
receiving a FYI or a FUP voucher through the U.S. Department of Housing
and Urban Development an eligible population under Chafee for services
and case management. A requirement of these housing voucher programs
administered by HUD is that the public child welfare agency offer case
management and supportive services to the young people receiving the
housing vouchers. However, some young people formerly in foster care
who qualify for a HUD voucher do not qualify for Chafee-funded services
due to their current age or the age at which they experienced foster
care. This limitation has prevented some communities from being able to
make use of the FYI/FUP vouchers. Making FYI/FUP voucher recipients an
eligible recipient of Chafee services would better align the programs,
providing greater opportunity for youth who are homeless or at risk of
homelessness to receive needed supports.
federal foster care reimbursement for kinship families
Question. The budget request proposes a higher Federal foster care
reimbursement for kinship families compared to non-relative foster
families.
Is there concern that a discrepancy in reimbursement rates will
escalate the shortage of non-relative foster families that many States
are experiencing?
Answer. The Administration for Children and Families' Children's
Bureau recognizes the important role that both kin and non-relative
foster families play in caring for children in foster care and we are
committed to assisting title IV-E agencies to expand and retain diverse
pools of qualified foster families to care for children, when needed.
We do not believe that the proposal to increase the Federal Financial
Participation (FFP) rate paid to title IV-E agencies for relative and
kin families will negatively impact the pool of unrelated foster
families. The proposal would not change the foster maintenance payment
rates that title IV-E agencies pay to either kin or non-related foster
parents, as Federal law does not allow paying licensed foster parents
different rates based on whether the foster care provider is related or
unrelated. Rather, the proposal would provide an added financial
incentive for title IV-E agencies to prioritize placing children with
relatives or kin when such placements are available and appropriate.
This proposal would improve outcomes for children and families, while
continuing to ensure that unrelated foster family homes are available
to support children and youth for whom no appropriate kin placement is
available.
When children cannot remain safely with their parents and must
enter foster care, placement with a relative or kin can often be the
best option; research is clear that children in kinship care often
experience less trauma and have better outcomes across a range of
behavioral and developmental well-being measures. Current law
recognizes the benefits of kinship care, as title IV-E of the Social
Security Act requires agencies to identify and give priority
consideration to relatives as foster care placements for children in
care.
This proposal would further align Federal policy with the priority
on relative placements by increasing the FFP Rate used to reimburse
title IV-E agencies for maintenance and assistance payments paid on
behalf of eligible children in both the title IV-E Foster Care and
Guardianship Assistance programs. Currently, title IV-E agencies are
reimbursed at the Federal Medical Assistance Percentage (FMAP) rate
(which ranges from 50 percent to 83 percent, depending on the per
capita income of the jurisdiction) for all foster care placements. This
proposal would increase FFP to FMAP plus 10 percentage points (i.e., 60
percent to 93 percent) for relative and kin placements, while non-
relative family foster homes placements would continue to be reimbursed
at the FMAP rate.
pharmacy benefit managers
Question. During my 2-year landmark bipartisan insulin
investigation with Senator Wyden, we studied why and how the price of
insulin has increased so dramatically in recent years. The
investigation found that manufacturer rebates are associated with high
list price in the insulin therapeutic class. PBMs leverage their size
to extract higher rebates, discounts, and fees from insulin
manufacturers, because PBMs consider insulin products to be
interchangeable. While rebates are used to keep insurance premiums low,
for those patients with high-deductible health plans, no insurance, or
for those who are underinsured, the practice of offering rebates
results in high list prices at the counter. This causes some patients
to ration their medication or forgo their medication entirely. With
Senator Cantwell, I have introduced and unanimously passed out of the
Judiciary Committee the Prescription Pricing for the People Act to
bring transparency to the PBM industry. The bill directs the Federal
Trade Commission (FTC) to study PBMs and make recommendations on the
effects of consolidation on pricing and anti-competitive behavior. I am
concerned about the potential manipulation by PBMs (e.g., copay
clawbacks, DIR fee clawbacks, formulary exclusion, high cost tiering,
contracting practices to keep small and independent pharmacists from
competing), especially the impact of these practices on patient access
and costs. Most recently, I pressed the FTC to investigate PBMs' role
in consumer drug prices. I urged the FTC to find consensus and move
forward on a study examining bipartisan concerns about competition
within the PBM industry.
While I remain committed to passing the bipartisan and negotiated
Wyden-
Grassley Prescription Drug Pricing Reduction Act (PDPRA) along with the
Grassley-Cantwell Prescription Pricing for the People Act, what is the
Biden administration doing to address potential manipulation by PBMs
that negatively impact patient access and costs?
Answer. HHS is committed to reducing drug prices and ensuring that
Americans have access to affordable prescription drugs. In the CY 2023
Medicare Advantage and Part D Final Rule, CMS finalized a policy that
requires Part D plans to apply all price concessions they receive from
network pharmacies to the negotiated price at the point of sale, so
that the beneficiary can also share in the savings. Specifically, CMS
is redefining the negotiated price as the baseline, or lowest possible,
payment to a pharmacy, effective January 1, 2024. CMS is applying the
finalized policy across all phases of the Part D benefit. This policy
reduces beneficiary out-of-pocket costs and improves price transparency
and market competition in the Part D program.
autonomous health care artificial intelligence (ai)
Question. Autonomous health care artificial intelligence (AI)
allows providers to test people with diabetes for diabetic retinopathy,
the causes blindness, using technology produced in Iowa that has been
validated for safety and efficacy. Also, other FDA-regulated health-
care AI is improving patient outcomes and removing barriers for rural
America. FDA's work to ensure AI ``Software as a Medical Device''
(SaMD) is safe and effective through the De Novo and 510(k) processes.
However, this industry is evolving. Patient access to AI systems
already authorized for marketing can be impacted by the existing 510(k)
process that is required for each software/
hardware update. This regulatory process could result in avoidable
access to care challenges/outcomes, such as vision loss and blindness
due to lack of access to improved technology. The FDA published a
discussion paper proposing the ``Predetermined Change Control Plan''
(PCCP) as a solution.
Is the FDA still considering PCCP as the solution?
Answer. Yes, predetermined change control plans (PCCP) may be used
to help ensure that FDA's statutory standards are met for approval or
clearance of artificial intelligence (AI) devices. Because device
changes made in accordance with a PCCP do not require additional FDA
premarket review before the change is deployed, PCCPs can allow
patients to have more timely access to innovative devices and also to
have the benefits of updates to devices more quickly.
Question. How can HHS ensure that patients have access to safe and
effective innovations?
Answer. The predetermined change control plan (PCCP), by including
the types of anticipated modifications to implement changes and
associated methodology to implement those changes in a controlled
manner, will allow FDA the oversight to enable responsible enhancements
in a manner that manages risks to patients. FDA notes that it is
critical for these plans to be evaluated as part of the premarket
submission for an individual device or in connection to a specific
device.
FDA considers a PCCP to be part of the technological
characteristics of the device. Evaluating the PCCP outside of a
premarket application, therefore, would be akin to evaluating part, but
not all, of a device's technological characteristics with no context.
______
Questions Submitted by Hon. John Thune
ihs electronic health record system
Question. Thank you for including more specific information in the
budget on the need to update the Indian Health Service's electronic
health record system. I know I've asked about this just about every
year to make sure we don't lose sight of it. That said, the information
included in the budget seems to be in the context of a major change in
how IHS is funded.
Can you tell me how the Department will continue to approach IT
modernization if the larger IHS proposal is not adopted?
Answer. Significant delays in funding, or failure to fund fully,
will continue to exacerbate the issues that have driven the need to
modernize IHS Health IT, including outdated core technology requiring
significant workforce and support, limited interoperability, fragmented
data, and extended project timelines. If the proposal is not adopted in
full, IHS will be in the position of partially modernizing, since the
agency is in process of expending the funds already appropriated for
this purpose. This will leave the agency with a combination of legacy
and modern systems, which will be costly and high risk from the
standpoints of performance, security, and patient safety, and
ultimately will be unsustainable.
prior authorization
Question. The Department recently responded to a letter Senator
Brown and I led on the use of prior authorization under Medicare
Advantage. Absent administrative action, I am hopeful we could possibly
address this issue in the forthcoming Senate Finance mental health
package.
Will you commit to working with this committee on either an
administrative or legislative solution, like the Improving Seniors'
Access to Timely Care Act?
Answer. CMS is committed to ensuring that the MA program provides
high-
quality care for beneficiaries and timely access to necessary and
appropriate health-care services. We also continue to examine ways in
which we can streamline processes like prior authorization, including
through the use of technology, to make them less burdensome on patients
and providers. As included in the current Unified Agenda and Regulatory
Plan, CMS plans to publish a proposed rule that would place new
requirements on MA organizations, as well as other entities, to improve
the electronic exchange of health-care data and streamline processes
related to prior authorization.
durable medical equipment reimbursement
Question. As you know, the CARES Act provided 75/25 blended rate
for durable medical equipment providers in non-rural, non-competitively
bid areas during the pandemic. It's my understanding that CMS does not
currently plan to continue that payment beyond the public health
emergency.
How has the agency communicated its plans to providers that will
still face some of the same travel and volume challenges that they did
prior to the pandemic and have likely been exacerbated since?
Answer. In the December 2021 final rule (86 FR 73860), CMS
finalized that the DMEPOS fee schedule will be equal to 100 percent of
the adjusted payment amount established in non-rural, non-competitive
bid areas (CBAs) within the contiguous United States after the public
health emergency period ends. We stated we believed the purpose of
section 3712 of the CARES Act was to aid suppliers in furnishing items
under very challenging situations during the COVID-19 PHE (85 FR
27571). We have long maintained that the fully adjusted rates in non-
rural non-CBAs are sufficient; for instance, we indicated in the CY
2019 ESRD PPS DMEPOS proposed rule (83 FR 34382) that although the
average volume of items and services furnished by suppliers in non-
rural non-CBAs is lower than the average volume of items and services
furnished by suppliers in CBAs, the travel distances and costs for
these areas are lower than the travel distances and costs for CBAs. We
stated that because the travel distances and costs for these areas are
lower than the travel distances and costs for CBAs, we believe the
fully adjusted fee schedule amounts are sufficient.
In addition, assignment rates were above 99 percent in non-rural
contiguous non-CBAs when the fully adjusted rates were implemented. CMS
will continue to monitor payments in all non-CBAs, as well as health
outcomes, assignment rates, and other information.
______
Questions Submitted by Hon. Richard Burr
covid-19 and pandemic preparedness
Question. We are now 2 years in to the COVID-19 pandemic. While we
must remain vigilant against any future potentially dangerous variants,
we also have multiple tools at our disposal--tests, treatments, and
vaccines--that allow us to start living our lives again. The end date
of a number of Medicare, Medicaid, and other coverage policies are tied
to the end of the public health emergency. Our States, beneficiaries,
and other stakeholders need a clear and transparent understanding of
what to expect and when to expect it.
What steps are you taking to prepare to wind down the public health
emergency declaration?
Answer. As a result of the continued consequences of the COVID-19
pandemic and after consultation with public health officials, Secretary
Becerra renewed the public health emergency (PHE) on January 14, 2022,
for up to an additional 90 days. The determination to renew the PHE
ensures response efforts can continue at the level needed to address
the ongoing impact of the virus. HHS will continue to evaluate whether
a public health emergency exists and will modify the PHE, as needed. We
have committed that we would provide a 60-day notice prior to removing
the PHE.
The budget requests funding to prepare for and respond to future
pandemics and high consequence biological threats. HHS's comprehensive
plan of action meets the President's objectives to transform our
national pandemic preparedness. The FY 2023 President's budget includes
$81.7 billion in mandatory funding over 5 years across the Office of
the Assistant Secretary for Preparedness and Response (ASPR), Centers
for Disease Control and Prevention (CDC), National Institutes of Health
(NIH), and Food and Drug Administration (FDA) to support President
Biden's plan to transform U.S. capabilities to prepare for and respond
rapidly and effectively to future pandemics and other high consequence
biological threats. This investment will fund transformative
improvements in our capabilities to prevent, detect, and respond to
emerging biological catastrophes.
The additional funding requested in the budget for HHS will help
transform our capability to rapidly produce and deliver countermeasures
against pandemics and other biological threats; strengthen our public
health infrastructure and early warning capabilities; invest in basic
research to enable an effective response to novel pandemics and
biological threats; modernize and streamline our regulatory
infrastructure; and, advance biosafety and biosecurity in the United
States and globally to prevent biological incidents.
Question. How are you planning to provide the necessary clarity
regarding current waivers and flexibilities and how to transition
programs in advance of the emergency ending?
Answer. The Secretary of HHS may, under section 319 of the Public
Health Service (PHS) Act, determine that: (a) a disease or disorder
presents a public health emergency (PHE); or (b) that a public health
emergency, including significant outbreaks of infectious disease or
bioterrorist attacks, otherwise exists. If and when declared, a PHE
lasts for the duration of the emergency or up to 90 days, but may be
renewed as needed and as determined by the Secretary. Under section
319, PHEs can enable the Secretary to take a variety of discretionary
actions to respond to the PHE, including waive or modify certain
Medicare, Medicaid, Children's Health Insurance Program (CHIP), and
Health Insurance Portability and Accountability Act (HIPAA) Privacy
Rule requirements under section 1135 of the SSA.
commercialization of covid-19 response
Question. As we start to live with COVID-19, we need to consider
how we begin to transition some of our Federal COVID response efforts
to the commercial market. For example, the Federal Government is
currently the sole purchaser of COVID-19 vaccines. Part of the
additional funding requested for the COVID-19 response will help to
ensure that there is a smooth transition to commercialization and that
challenges are addressed with shifting vaccines and other
countermeasures to the commercial market.
As these products continue to become more a part of everyday health
care, how will you transition responsibilities for distributing and
paying for them to the commercial market?
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 fails to continue to
fund 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. As part of the additional funding
request for the COVID-19 response, funding is needed to ensure that
there is a smooth transition and that challenges are addressed with
shifting vaccines and other countermeasures to the commercial market.
Question. What are the biggest barriers, if any, that stand in the
way of making this transition?
Answer. As noted in the response to question 118, many factors
remain--including possible congressional action on our funding
request--in order to transition vaccines from Federal acquisition to
the commercial market. We look forward to working with Congress to
ensure continued and equitable access to these lifesaving vaccines.
drug pricing
Question. The budget proposal includes a placeholder for reckless
tax-and-spend legislation that would include a proposal allowing you to
dictate the price of medicines. The proposal is fundamental flawed and
would have a chilling effect on innovation and Americans' health would
be worse off as a result.
What assumptions does the President's budget make as to how you
would value different clinical factors when determining the price of
drugs?
How do the President's proposed drug price controls make our
domestic life sciences industry more competitive with China?
Economists from the University of Chicago have estimated that the
proposed drug price controls would result in 135 less new medicines
through 2039.\10\ For what diseases or conditions are the Biden
administration willing to forego new innovative treatments and cures?
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\10\ https://cpb-us-w2.wpmucdn.com/voices.uchicago.edu/dist/d/3128/
files/2021/08/Issue-Brief-Drug-Pricing-in-HR-5376-11.30.pdf.
Answer. HHS looks forward to working with the Congress to lower
health-care 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. In September
2021, HHS released a comprehensive plan to lower drug prices. The Drug
Pricing Plan presents principles for equitable drug pricing reform
through competition, innovation, and transparency; describes promising
legislative approaches; and summarizes actions already underway or
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under consideration across HHS.
One of the key policies in this effort is legislation that would
allow the Secretary of HHS to negotiate Medicare Part B and Part D drug
prices directly with pharmaceutical companies and make those prices
available to other purchasers, an approach that is projected to
generate reductions in patient cost sharing and large savings for
patients, government, and commercial payers. The Drug Pricing Plan also
describes the administrative tools HHS can use to promote competition
and reduce drug prices, including testing models through CMS's
Innovation Center and collecting more data from insurers and Pharmacy
Benefit Managers to improve transparency about prices and out-of-pocket
spending on prescription medications.
HHS is committed to continuing our work to make health care more
affordable for American families. By promoting negotiation,
competition, and innovation in the health-care industry, HHS will
ensure cost fairness and protect access to care.
clinical lab fee schedule
Question. The Protecting Access to Medicare Act of 2014 (PAMA)
reformed the Clinical Laboratory Fee Schedule (CLFS) from a collection
of over 50 regional fee schedules to a single, national fee schedule
with market-based rates. For Medicare beneficiaries to have sustained
access to clinical laboratory services, CLFS rates must be based on
accurate and representative private market data from all clinical
laboratory segments that provide services to beneficiaries.
Implementation of PAMA, however, excluded large segments of the
market, which has resulted in drastic cuts to clinical laboratories
that Congress has now mitigated multiple times. Does the President's
budget propose changes to the CLFS to ensure sustainable access to
high-quality services for beneficiaries?
Answer. CMS and HHS continue to ensure increased access to
equitable quality care, including clinical laboratory services. The
Department of Health and Human Services cannot comment on the subject
of ongoing litigation.
health insurance regulation
Question. Section 1311(e)(1) of the Affordable Care Act allows
exchanges to certify a health plan as a qualified health plan if it
meets certain requirements. One such requirement affords the exchanges
the ability to make determinations as to whether or not a health plan
is ``in the interests of qualified individuals.''
How many times has a health plan not been determined to be in the
interests of qualified individuals?
For States that operate their own State-based exchanges or handle
their own plan management functions, are you deferential to those
States in making such a determination? How do you take into account the
opinion of those States?
Answer. Ensuring that all Americans have access to quality,
affordable health care is one of the Biden-Harris administration's top
priorities. Patients and their families deserve the security of knowing
that the insurance they buy will be there for them when they need it,
and we need to make sure consumers are protected and understand the
health insurance they are buying. This is why CMS ensures that all
health plans, including dental, must meet a number of statutory and
regulatory standards in order to be certified as QHPs in the Federally
Facilitated Marketplaces (FFMs). States that operate their own
marketplaces are responsible for certification of QHPs on those
marketplaces. For States that perform plan management functions for the
FFMs in those States, CMS works collaboratively with the State but CMS
makes final determinations regarding QHP certification.
access to innovative products
Question. During your nomination process, you responded to my
question for the record on FDA-CMS coordination with the following: ``I
will support appropriate measures to enable payors to make informed
decisions earlier in the process.''
Since that time, CMS has rescinded a regulation that would have
expedited Medicare beneficiary access to innovative technologies and
promulgated a coverage decision that would subject treatments that have
met the FDA's gold standard of safety and efficacy for terminally ill
Alzheimer's patients to coverage with evidence development. In other
words, another round of trials.
Please provide specific examples of what you have done to improve
patient access to innovative treatments and technologies through
increased coordination of FDA and CMS.
Answer. Ensuring the availability of innovative interventions is a
shared priority for both CMS and the FDA. HHS recognizes the important
and related--but different--roles of these respective agencies and know
that CMS and FDA decisions have an outsized impact on the U.S. health-
care system, as well as implications for the rest of the world.
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. In some
instances, the FDA has the authority to require additional studies
after approval to provide additional information like for example
additional information regarding the anticipated clinical benefit of a
medical product.
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 work of both agencies is critical to ensure
that medical products are available to people across the country.
The agencies also have in place a Memorandum of Understanding to
promote collaboration and enhance knowledge and efficiency by providing
for the sharing of information and expertise. In addition, the Parallel
Review Program allows both agencies to simultaneously review submitted
clinical trial data with the goal of decreasing the time between FDA's
approval of a premarket application and the subsequent CMS national
coverage determination.
______
Questions Submitted by Hon. Rob Portman
build america, buy america provision in infrastructure
investment and jobs act (iija)
Question. The Infrastructure Investment and Jobs Act (IIJA)
contains new requirements related to Buy America. Specifically, the
IIJA includes my ``Build America, Buy America'' (BABA) provision, which
requires all iron, steel, manufactured products, and construction
materials used in all federally assisted infrastructure projects are
produced in the United States.
To apply the Buy America standard government-wide, section 70913 of
the IIJA requires the head of each Federal agency to catalog all
Federal financial assistance programs administered by the agency,
review existing domestic content preferences, and identify all
``deficient programs'' that do not meet the Buy America policy in the
bill. In its report to OMB pursuant to section 70913, HHS acknowledges
that it provides Federal support for infrastructure-related
construction activities under the law, but does not consider this
Federal financial assistance to be subject to the BABA requirements.
This is inconsistent with the requirements of the law.
What is HHS's legal rationale for claiming that its Federal
financial assistance for infrastructure projects is not subject to
BABA? Is there a rationale for these claims, which are inconsistent
with the new law?
Answer. HHS conducted an iterative and thorough review of all HHS
programs pursuant to section 70913 of the Infrastructure Investment and
Jobs Act (IIJA). Using the definitions outlined in section 70912, we
determined that the Build America, Buy America (BABA) requirements
extend beyond the scope of HHS's programs. Specifically, the financial
assistance programs funded by HHS focus on medical research, health
services, and essential human services. As part of this focus, HHS
occasionally provides construction support for health centers, medical
centers, and research facilities. The IIJA through the BABA, focuses on
sectors of domestic infrastructure well beyond the scope of HHS's
programs. Therefore, in HHS' assessment, the new requirements it
imposes on Federal financial assistance do not apply to HHS financial
assistance spending. If it is determined on a case-by-case basis that
the BABA requirements apply to any particular Federal financial
assistance provided by HHS, HHS has agreed to evaluate whether pursuing
a waiver authorized by statute is appropriate.
maternal, infant, early childhood home visiting program
Question. Ohio families have benefited from the MIECHV program--it
is a bright spot among so many programs that serve low-income families
in that it's voluntary and evidence-based. MIECHV models show well-
documented evidence of how trained professionals support better newborn
care and improved maternal mental health.
I'm glad that the administration sees the value in this program and
I look forward to partnering with my Democratic colleagues to move a
bipartisan reauthorization bill before the program expires on September
30th.
I look forward to working with you on this program that serves
disadvantaged communities. You are aware of my interest in working on
behavioral health issues; in what ways are home visitors helping
mothers manage mental health issues?
Answer. Thank you for your support for the MIECHV program, and we
look forward to working with you on its reauthorization. As you know,
the program supports voluntary, evidence-based home visiting services
for pregnant individuals and parents with young children up to
kindergarten entry living in communities at risk for poor maternal and
child health outcomes. Home visitors connect families to health, mental
health, child care and other community services, and support a focus on
positive parenting and early childhood development. Home visiting
programs directly support maternal mental health through the
identification of mental health issues, including regular screening for
maternal depression and the connection of families with needed mental
health treatment and services through coordination and referral. In FY
2021, 81 percent of primary caregivers enrolled in home visiting were
screened for depression using a validated tool within 3 months of
enrollment or 3 months of delivery.
HRSA also funds the Home Visiting Collaborative Improvement and
Innovation Network (HV-CoIIN), which builds capacity for quality
improvement in local home visiting agencies to improve maternal and
child health outcomes, including methods to better identify and address
maternal depression. Among home visiting programs participating in the
HV-CoIIN, 91 percent of mothers were screened for depression at the
time of enrollment and 71 percent of mothers who screened positive for
depression accepted referrals for treatment.\11\
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\11\ https://hv-coiin.edc.org/sites/hv-coiin.edc.org/files/
HV%20CoIIN%202.0%20MD%20Fact%
20Sheet%20-%202021.pdf.
Many MIECHV programs also implement infant early childhood mental
health consultation, which connects a mental health professional with
home visitors. The goal of infant early childhood mental health
consultation is to provide home visitors with the knowledge and skills
needed to identify and work with families with behavioral health
challenges. Infant early childhood mental health consultation training
helps home visitors address the complex needs of families impacted by
substance use disorder, mental illness, intimate partner violence, or
other issues. Home visitors engaged in infant early childhood mental
health consultation are able to conduct screenings with caregivers and
children, address behavioral health and child development needs, and
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connect families to mental health and other supports.
______
Questions Submitted by Hon. Tim Scott
preserving patient access to home infusion act
Question. I applaud the focused and prioritized efforts HHS and CMS
are taking to address health disparities. One of the tools we have to
help address these disparities is providing care in the home,
connecting with patients where they are. This is especially important
in rural or underserved communities, like those across South Carolina
that lack certain health-care resources.
In support of Medicare beneficiaries that rely on IV medications to
treat their health conditions, Congress passed legislation in 2016 to
create a new home infusion therapy benefit to allow them to receive
their infused medications at home without having to travel to a
doctor's office or hospital to receive their infusion. While recent
data published by CMS acknowledges that utilization of the new home
infusion therapy benefit has been ``low,'' the agency has failed to
address the concerns that Congress has raised with the way it's been
implemented.
That's why I'm working with my colleague from Virginia to address a
concerning trend in access to home infusion therapy services that has
occurred since this law was implemented. We recently introduced the
Preserving Patient Access to Home Infusion Act that would ensure that
the benefit is being interpreted according to congressional intent and
would build on the successful private market model, creating better
access to home infusion for vulnerable home infusion recipients.
Will you commit to working with us on this bipartisan bill to
address the health disparity challenges in home infusion?
Answer. The Biden-Harris administration supports strengthening home
and
community-based services 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 such as a nursing home. Home infusion
therapy services can play in important role in allowing beneficiaries
to continue receiving care within their own home instead of in a
hospital or physician office. Per the statute, the Medicare home
infusion therapy services benefit covers professional services,
including nursing services, training and education not already provided
under the durable medical equipment (DME) benefit, remote monitoring
and monitoring services. The home infusion therapy services benefit
works in tandem with the DME benefit. DME suppliers are responsible for
furnishing the infusion pump (including training the patient and/or
caregiver on how to use the infusion pump), the drug or biological, and
any pharmacy services associated with furnishing the drug or
biological. We note that patients and/or their caregivers must be able
to self-administer home infusion drugs in order for the pump and drug
to be covered under the DME benefit.
In November 2021, CMS issued the CY 2022 Home Health Prospective
Payment System Rate Update Final Rule (CMS-1747-F). In addition to
updating the geographic adjustment factor used for wage adjustment, the
final rule updated the home infusion therapy services payment rates for
CY 2022 as required by law. The overall economic impact of updating the
payment rates for home infusion therapy services is expected to be an
increase in payments to home infusion therapy suppliers of 5.1 percent.
HHS looks forward to working with Congress and other stakeholders
to improve the critical home health-care services that allow
beneficiaries to remain in their homes and communities.
public health emergency and waivers
Question. Does this administration envision ending the public
health emergency tied to COVID-19, and if so, what data points will
drive that decision--hospitalization or community transmission?
Answer. As a result of the continued consequences of the COVID-19
pandemic and after consultation with public health officials, Secretary
Becerra renewed the public health emergency (PHE) on January 14, 2022,
for up to an additional 90 days. The determination to renew the PHE
ensures response efforts can continue at the level needed to address
the ongoing impact of the virus. HHS will continue to evaluate whether
a public health emergency exists and will modify the PHE, as needed. We
have committed that we would provide a 60-day notice prior to removing
the PHE.
Question. We've seen a lot of innovation throughout this pandemic,
and while we're ready to leave COVID in the rearview mirror--these
innovations shouldn't be left behind. How much lead time will this
administration provide to Congress in order to consider which health
waivers should continue past the public health emergency?
Answer. The Secretary of HHS may, under section 319 of the Public
Health Service (PHS) Act, determine that: (a) a disease or disorder
presents a public health emergency (PHE); or (b) that a public health
emergency, including significant outbreaks of infectious disease or
bioterrorist attacks, otherwise exists. If and when declared, a PHE
lasts for the duration of the emergency or up to 90 days, but may be
renewed as needed and as determined by the Secretary. Under section
319, PHEs can enable the Secretary to take a variety of discretionary
actions to respond to the PHE, including waive or modify certain
Medicare, Medicaid, Children's Health Insurance Program (CHIP), and
Health Insurance Portability and Accountability Act (HIPAA) Privacy
Rule requirements under section 1135 of the SSA.
telehealth
Question. Telehealth is certainly popular (and for good reason).
The administration's budget extends Medicare's telehealth waiver
flexibilities past the anticipated expiration of the public health
emergency tied to COVID-19.
Could you elaborate and provide more detail on the policies this
administration would support for the expansion of telehealth?
How does this administration plan to work with Congress to ensure
millions of Medicare beneficiaries don't lose access to telehealth
services and abruptly fall off the ``telehealth cliff''?
Answer. During the COVID-19 public health emergency, telehealth has
been a reliable resource to allow providers to reach patients directly
in their homes in order to ensure access to care and continuity of
services. The Biden-Harris 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. 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 health
care, among other services. Medicare beneficiaries can access care
directly in their homes thanks to recent regulations, including CMS's
CY 2022 Physician Fee Schedule final rule, that allow for certain
behavioral health services via audio-only telephone calls. In addition,
the President's FY 2023 budget includes a proposal to remove statutory
limits on the list of providers 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.
acute hospital care at home waiver
Question. In November 2020, CMS announced its Acute Hospital Care
at Home Waiver program in an effort to decompress the Nation's
hospitals during the COVID-19 pandemic. This program, in which over 200
hospitals across 34 States are currently participating, provides full
inpatient payment for providers delivering hospital-level care in the
home.
As Congress considers potential extension of certain waiver
authorities past the public health emergency, does the agency have any
data available on the value of this program and, if not, when does the
agency expect to have that data and will it be made publicly available?
Answer. Hospitals participating in the Acute Hospital Care at Home
program must submit monitoring data to CMS on a monthly or weekly
basis, the frequency of which depends on whether the hospital was
approved for participation via the expedited waiver pathway or the
detailed waiver pathway. The data they must submit includes patient
volume, unanticipated mortality during an acute episode of care, and
the escalation rate (how many patient discharges involved a transfer to
the traditional inpatient hospital setting from the acute hospital care
at home program). An article was published in the New England Journal
of Medicine Catalyst on December 7, 2021, entitled ``Acute Hospital
Care at Home: The CMS Waiver Experience,'' which provides information
about the waiver design, requirements for hospital waiver approval,
geographic distribution of waiver uptake, and monitoring for patient
safety. The article contains aggregate data collected from hospital, as
of October 27, 2021 on total patients served, escalations, and
unexpected mortality. Although a thorough analysis of the program is
not yet possible, the article explains what CMS has learned from the
program thus far.
diverse trials act
Question. Last year, HHS put forward five strategic goals, and
several touch directly on access to participation in cutting edge
clinical research for everyone regardless of socioeconomic status.
While the U.S. conducts some of the most advanced medical research in
the world, and South Carolina is proud to have world-class research
institutions, the reality is that today not everyone can participate in
a clinical trial because they can't afford the extra costs involved
with travel to distant sites where trials are being run. Those South
Carolinians living in the most rural parts of the State farthest from
academic research centers are disadvantaged the most. During the
pandemic, we saw a dramatic uptick in the use of telemedicine and
remote care, even crossing over into how clinical trials were run, with
FDA temporarily allowing clinical trial participants to get some of
their care in their home, or closer to home in a model known
as``decentralized trials.''
Recently, I joined my colleague from New Jersey in introducing the
bipartisan DIVERSE Trials Act to enable decentralized clinical trials
and allow clinical trial sponsors to be able to provide financial
assistance to participating patients for things like travel and parking
without fear of being charged by HHS with violating Federal anti-
kickback laws.
As the pandemic phase draws to a close, is HHS considering making
some of these remote research practices permanently allowable so that
South Carolinians representing a diverse array of background and
locations, who have been traditionally left out of clinical trials, can
continue participate?
Answer. Even before the pandemic, FDA supported, and sponsors were
utilizing, decentralized clinical trials to bring the trial to patients
and facilitate broader access to clinical research. Due to the
restrictions on travel and other logistics to control the spread of
disease, the COVID-19 pandemic increased the use of these trial
designs, and the agency expects such use to continue after the pandemic
ends. Decentralized clinical trials were not a temporary or interim
measure employed solely for the purposes of the pandemic. When
appropriately implemented in accordance with regulatory requirements
applicable to all clinical trials, such trials have significant
potential to broaden the availability of clinical research to
historically underrepresented populations and FDA expect sponsors will
continue to utilize them.
Question. Given the reality of inflation--its disproportionate
impact on rural communities, low-income communities, and communities of
color--should clinical trial sponsors be able to provide financial
assistance to patients for costs, like travel and parking, that are
incurred while participating in a clinical trial to help increase the
diversity pool of participants?
Answer. As a general matter, FDA does not consider reimbursement
for travel expenses to and from the clinical trial site and associated
costs such as airfare, parking, and lodging to raise issues regarding
undue influence. Similarly, consideration may be given to paying
participants in exchange for their participation in research. Such
payments are a common and, from FDA's perspective, may be an acceptable
practice. FDA recognizes that payment for participation may raise
difficult questions that should be addressed by the institutional
review board (IRB). Other than reimbursement for reasonable travel and
lodging expenses, IRBs should be sensitive to whether other aspects of
proposed payment for participation could present an undue influence,
thus interfering with the potential subjects' ability to give voluntary
informed consent. In addition, FDA recognizes that other laws, such as
the Federal anti-kickback statute, could apply to reimbursement for
travel expenses and associated costs, as well as payments for clinical
trial participation. For any questions regarding the application of the
Federal anti-kickback statute, please consult with the Department of
Justice and the Department of Health and Human Services Office of
Inspector General.
medicare advantage
Question. In February, I co-led a letter to CMS signed by 63
bipartisan Senators urging the agency to maintain stability for the
over 27 million seniors that rely on Medicare Advantage--including over
447,000 South Carolinians. Medicare Advantage seniors report high
beneficiary satisfaction rates and have access to benefits not
available in Medicare fee-for-service, such as out-of-pocket cost
limits, in-home care, fitness, and meal and nutrition services.
How will you work with Congress to ensure that this coverage is
protected in the future for Medicare Advantage seniors, which is
supported by nearly two-thirds of senators?
Answer. HHS is committed to providing affordable, high-quality,
equitable coverage to all beneficiaries. Our goals for Medicare
Advantage mirror our vision for HHS programs as a whole, which include
advancing health equity; driving comprehensive, person-centered care;
and promoting affordability and sustainability of our programs. We look
forward to continuing to work with Congress to ensure a strong Medicare
Advantage program.
prevent diabetes act
Question. According to the CDC, on average, 48 percent of adults
over age 65 are pre-diabetic. According to the CMS actuary, people over
65 who successfully complete a CDC fully recognized diabetes prevention
program can save by preventing diabetes, on average, $2,600 over 3
years in avoided medical costs. Recent data from CDC shows that almost
11,000 people over 65 have successfully completed the Diabetes
Prevention Program from 2015-2019. In contrast, since 2018, only 2,200
people have participated in CMS's Medicare Diabetes Prevention Program
(as of March 2021). We also know that CDC recognizes three modalities
of diabetes prevention program delivery: in-person, on-line, and video/
synchronous, while Medicare allows only in-person programs.
Can you explain why Medicare doesn't allow any CDC recognized
program to serve its population, since obviously, more modalities would
increase supply substantially and align with CDC's evidence based
program?
Answer. Innovation is important to advancing goals in health care,
and the CMS Innovation Center is integral to the administration's
efforts to promote high-value care and encourage health-care provider
innovation, including virtual and digital health innovation. With
respect to the Medicare Diabetes Prevention Program (MDPP) expanded
model, in the Calendar Year 2022 Physician Fee Schedule final rule CMS
finalized a policy to use the CMS Innovation Center's waiver authority
to waive the provider enrollment Medicare application fee for all
organizations that submit an application to enroll in Medicare as an
MDPP supplier on or after January 1, 2022. This change waives the
Medicare enrollment fee for MDPP suppliers beyond the end of the COVID-
19 public health emergency (PHE). We believe that granting a waiver of
the enrollment fee for MDPP suppliers will increase MDPP supplier
enrollment, which will ultimately improve beneficiary access to the
expanded model.
CMS issued regulatory flexibilities in response to the COVID-19
pandemic, including waiving the limit on virtual sessions that can be
provided by MDPP suppliers when in-person classes are not safe or
feasible. While CMS is committed to working with Congress to consider
which pandemic flexibilities should potentially be extended, MDPP
suppliers must remain prepared to resume delivery of MDPP services in-
person to start new cohorts and to serve beneficiaries who wish to
return to in-person services when the flexibilities granted during the
pandemic are no longer in effect.
Last summer, I requested technical assistance from CMS on the
PREVENT DIABETES Act, a bipartisan, bicameral bill that would ensure
that Medicare beneficiaries have the opportunity to have MDPP through
the same choice of modalities (in person, online, virtual) as to people
in the commercial insurance marketplace. To date, we have not received
that technical assistance.
Question. Can you provide an update with the status of that
technical assistance?
Answer. HHS always appreciates the opportunity to provide technical
assistance to Congress on important health-care issues. It is my
understanding that my team has sent your office the requested technical
assistance, and we regret the delay.
______
Questions Submitted by Hon. James Lankford
gender dysphoria
Question. On March 2nd, HHS Office for Civil Rights issued ``HHS
Notice and Guidance on Gender Affirming Care, Civil Rights, and Patient
Privacy.'' This guidance, as well as HHS's concerning decision to
reinterpret and greatly expand the scope of sex discrimination in
Section 1557 of the Affordable Care Act, suggests that doctors and
other medical professionals are required to provide potentially
harmful, experimental procedures on children who are experiencing
gender dysphoria. The guidance goes further to affirm such treatment by
claiming that it ``improves their physical and mental health.'' It also
refers to the procedures as ``lifesaving.''
I'm concerned by the steps this administration and HHS are taking
to affirm--and even encourage--the medical transition of children with
gender dysphoria, regardless of parental involvement. Similarly, this
guidance and other statements made by you and other administration
officials suggests a desire to compel medical professionals to provide
such treatment and demand States do nothing to protect children from
potential harm.
What studies is HHS and this administration relying on to determine
the long-term health implications that medical treatments for gender
dysphoria have on children?
What are the known long-term effects of puberty blockers for the
purpose of responding to gender dysphoria if such treatment begins at 8
years old? What about 12 years old? What about 16 years old?
What are the known long-term effects of cross-sex hormones for the
purpose of responding to gender dysphoria if such treatment begins at 8
years old? What about 12 years old? What about 16 years old?
Based on the medical evidence that exists, do you believe that it
is appropriate for children to receive such treatment?
If so, at what age do you think it is medically and ethically
appropriate for a child to give consent to receive a treatment with
such lasting and adverse effects such as permanent damage to brain
development or infertility?
Do you agree that at a minimum, parental consent is necessary for
children to engage in any transgender care?
Would you agree that no taxpayer dollars should be used to perform
a transition procedure on a child who cannot reasonably provide
informed consent?
Answer. HHS would recommend consulting with medical associations
regarding standards of care. Generally speaking, care is between a
patient, their family, and their health-care provider.
Question. Would you agree that medical professionals should not be
compelled to participate in such treatment if it goes against their
sincerely held religious beliefs, conscience, or best medical
judgement? Will the HHS OCR Conscience and Religious Freedom Division
enforce conscience protections for medical professionals who object to
participating in such treatments?
Answer. As in most other areas of practice, medical providers with
conscientious objections to providing gender-affirming care are not
obligated to provide this care. The Department takes seriously its
obligations to comply with the Religious Freedom Restoration Act, 42
U.S.C. 2000bb, et seq. and the range of Federal conscience protections
that apply to the provision of medical care. The Department treats any
violation of civil rights or religious freedoms seriously and will
continue to ensure that individuals are protected by reviewing,
investigating or taking other appropriate measures in response to
complaints received by the Office for Civil Rights regarding these
issues.
flags
Question. In addition to other actions HHS continues to take to
promote gender ideology, on March 31, HHS flew the ``transgender pride
flag'' on top of the agency's building. Can you provide a list of all
other flags HHS has flown over the building?
Answer. HHS flies the American flag, the HHS Department flag, and
the Public Health Services flag each day to symbolize HHS's commitment
to the health and well-being of all Americans.
faith-based child welfare providers
Question. The FY 2023 budget proposes to prohibit States and
federally funded child welfare providers from discriminating on the
basis of ``religious beliefs, sexual orientation, gender identity,
gender expression, or sex.'' This would as you know put faith-based
foster care and adoption agencies in a position of needing to choose
between violating their sincerely held religious beliefs or losing
funding and possibly licensure.
Senator Tim Scott (SC) and I sent you a letter about this in
December, which the Office for Civil Rights responded to in March
without answering a single question.
If this budget request is adopted, and faith-based providers are no
longer able to serve, what is your plan to make up for the loss of
those providers to find safe, loving and permanent families for
children in foster care?
Answer. The Administration for Children and Families' Children's
Bureau acknowledges the significant contributions that faith-based
providers make to delivering human and social services. We also note
that faith-based providers have different approaches to foster and
adoptive parenting recruiting, and some will continue to be involved
with foster and adoptive parent recruiting if the budget request is
adopted. Regardless, we will continue to encourage title IV-E agencies
to actively recruit foster and adoptive parents in manners that can
increase the pool of prospective parents for children who need care
when they cannot safely remain with their parents.
Question. What is your understanding of the holding in the
unanimous Supreme Court decision, Fulton v. Philadelphia? How does this
budget proposal align with Fulton?
Answer. A reasonable summary of the holdings of the majority
opinion is contained in the syllabus prepared by the Supreme Court's
Reporter of Decisions. The child welfare non-discrimination proposal
contained in the President's budget, if enacted, would be implemented
in a manner consistent with the Court's decision.
medicare part d formulary tiering
Question. In 2018, generic drugs accounted for 22 percent of all
drug spending despite the fact that 90 percent of dispensed
prescriptions were generic drugs. Additionally, the average copay of a
generic prescription ($5.63) is nearly one-seventh that of a brand-name
prescription ($40.65), offering significant savings for patients.
However, the current structure of Part D has shifted to incentivize
plans to favor rebates over lower-priced generic and biosimilar
alternatives. As a result, we have seen the number of generics placed
on the lowest-cost sharing tier drop dramatically in recent years. I'm
concerned about this trend and am working on legislation that would
address this problem.
As you know, in 2019, CMS proposed to prohibit Medicare Part D
plans' ability to place generic drugs on non-generic tiers and branded
drugs on non-brand tiers. CMS also suggested setting up a second
specialty tier for lower-cost drugs, but the data shows that very few
Part D plans have actually used this new tier.
It took CMS 6 months to provide initial feedback and technical
assistance to my team regarding my proposals. Will you commit to
continuing to engage with me on this in a timely manner to make sure
beneficiaries actually have access to low cost drugs?
Answer. The administration is advancing a multi-pronged approach to
improving competition in the prescription drug market, including
supporting greater availability and use of biosimilar biological
products and generic drugs in order to lower the prices Americans pay
for prescription drugs. CMS stands ready to work with Congress on this
issue.
______
Questions Submitted by Hon. Steve Daines
reproductive health access task force
Question. This past January you announced a new ``Reproductive
Health Access Task Force,'' to promote abortions at home and abroad,
and to combat pro-life State laws including parental involvement laws
and bans on late-terms abortions. Additionally, your budget once again
calls for eliminating the Hyde Amendment to allow taxpayer funding for
abortion on demand up to birth.
If the Supreme Court in the Dobbs case overturns Roe v. Wade and
returns to the States the power to protect pre-born children from
abortion, will you respect and comply with the decision of the Court,
including in the activities of this task force?
Will you commit, in the operation of this task force, to following
and enforcing the Hyde Amendment, the Federal ban on partial birth
abortion, and other Federal laws that protect pre-born children?
Does the task force intend to use Federal funds to advocate against
State laws that protect pre-born children from abortion or the laws of
sovereign nations?
Answer. I will continue to enforce the law.
hospital price transparency final rule
Question. Rising health-care costs impact Montanans and Americans
across the country, which is why I recognize the importance of efforts
to lower costs, empower patients, and improve transparency to help
folks make informed decisions about their care. As you may know,
studies have shown non-compliance with the Hospital Price Transparency
Final Rule. In fact, a study published in February 2022 by Patient
Rights Advocate.org reviewed 1,000 hospitals nationwide and found only
14.3 percent of hospitals are compliant with the rule that went into
effect over 1 year ago.
What actions do you plan on taking to assess non-compliance and
ensure hospitals comply with the rule so that price transparency is
available to all Americans?
Answer. Increasing access to affordable health care is a top
priority for the Biden-Harris administration. That's why HHS is
committed to ensuring that consumers have the information they need to
make fully informed decisions regarding their health care.
Hospital price transparency helps people know what a hospital
charges for the items and services it provides. Under CMS regulations,
hospitals must post on their website a machine-readable file containing
a list of all standard charges for the items and services they provide,
as well as a consumer-friendly list of standard charges for at least
300 shoppable services. CMS expects hospitals to comply with these
requirements, and is enforcing them to ensure people know what a
hospital charges for items and services.
In January 2021, CMS began proactive audits of hospital websites as
well as review of complaints submitted to CMS via the hospital price
transparency website. In April 2021, CMS 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. Hospitals that fail
to submit a corrective action plan or comply with the requirements of a
corrective action plan could be issued a notice of imposition of a
civil monetary penalty (CMP). In the event CMS issues a civil monetary
penalty, CMS will publish the notice of the CMP on a CMS website.
In the Calendar Year (CY) 2022 Hospital Outpatient Prospective
Payment and Ambulatory Surgical Center Payment Systems Final Rule (86
Fed. Reg. 63458), CMS finalized modifications to the hospital price
transparency regulations to increase compliance. The modifications
became effective January 1, 2022 and include the use of a scaling
factor to increase the amount of the civil money penalties based on
hospital bed count.
HHS looks forward to working with its partners across the Federal
Government, along with Congress and other stakeholders, to examine
additional ways to increase price transparency across the health-care
industry and improve access to affordable coverage and services.
______
Questions Submitted by Hon. Todd Young
organ procurement organizations (opos)
Question. I have long advocated for the Department of Health and
Human Services (HHS) to hold organ procurement organizations (OPOs)
accountable for their performance, including by decertifying failing
OPOs, and was happy to see HHS finalize a rule last November to do so.
This rule is projected to save more than 7,000 lives every year, and I,
along with bipartisan, bicameral leaders, wrote to you last summer
calling for the timeline of the rule to be accelerated, given how many
lives it would save.
I was disappointed to see a proposal in the President's budget that
would allow CMS to recertify failing OPOs. This proposal would hinder
OPO accountability and much needed reform to the organ transplant
system.
Can you commit to upholding HHS's OPO rule, ensuring that all
failing OPOs will be swiftly decertified?
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
recertification 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 recertification
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 recertification 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.
The President's FY 2023 budget includes a proposal that would
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 recertification
cycle. An OPO taking over a decertified OPO's low-
performing DSA may have a significant undertaking to increase their
performance to meet the Tier 1 top 25 percent benchmark to be
automatically recertified. An OPO may only have 1-2 years in a DSA they
took over from a low-performing OPO before being recertified. CMS
believes that having the discretion to determine whether to recertify
OPOs that have recently assumed responsibility for servicing a
previously low-performing DSA and are making significant improvement
would provide the flexibility it needs to improve organ procurement in
DSAs without disruption to organ procurement.
antimicrobial resistance--the pasteur act
Question. I was pleased to see the President's budget included a
proposal designed to combat antibiotic-resistant bacteria and fungi by
encouraging the development of innovative antimicrobial drugs. This
proposal, modeled after the PASTEUR Act, which I introduced along with
Senator Bennet, would allow the U.S. to make strategic investments in
antibiotic development much like those made for mRNA that eventually
led to a COVID-19 vaccine in record time.
I helped author and introduce the PASTEUR Act because, among other
reasons, I believe it will be more costly for the Federal Government to
do nothing. If current trends continue, we may one day soon find that
many surgeries are too risky to perform because physicians lack the
antibiotics needed to ensure apatient's safety.
The antibiotic drug manufacturer market is experiencing a
collapse--as identified in a New York Times article in 2019--and has
only gotten worse since. What steps can the Department take to help the
market survive until such time as Congress can act?
Answer. To mitigate the threat of antimicrobial resistance, the
U.S. Government is taking a multi-pronged approach that includes
surveillance, prevention, stewardship and innovation of new products to
treat and prevent infections. Goal 4 of the National Action Plan to
Combat Antibiotic-Resistant Bacteria (CARB), 2020-2025 (2020 CARB Plan)
is to accelerate basic and applied research and development for new
antibiotics, other therapeutics, and vaccines. Relevant activities are
implemented by the National Institutes of Health (NIH), the Biomedical
Advanced Research and Development Agency (BARDA) within the Office of
the Assistant Secretary for Preparedness and Response (ASPR), the Food
and Drug Administration (FDA), and the Department of Defense (DoD). The
2020 CARB Plan recognizes that the pipeline of new antibiotics must be
continually primed through discovery and development research, and the
plan includes multiple objectives to intensify support for basic,
preclinical, and clinical research. Further, Objective 4 within Goal 4
of the 2020 CARB Plan is to enhance efforts to promote sustainability
of the commercial market for new antibiotic products. It includes
specific objectives of streamlining clinical trials, strengthening
commercial markets through direct Public Health and National Security
purchases, and supporting U.S.-based manufacturing infrastructure. The
CARB Task Force continues to monitor and analyze the landscape of
product development; as part of this monitoring, it focuses on
difficulties experienced by developers and health-care providers in
generating and using treatment options.
In addition to these objectives within the 2020 CARB Plan, HHS
recognizes that the value of reduced morbidity, mortality, and disease
duration is not currently captured by many antimicrobial products'
current market value, and the development pipeline is at significant
risk of falling short of current and future needs. Therefore, the
Fiscal Year 2023 President's budget includes a proposal to create a
novel payment mechanism to stimulate future innovation in antimicrobial
products while enhancing stewardship of their appropriate use. Sponsors
of selected products would be eligible to enter into contracts with
HHS, valued between $750 million and $3 billion per contract, paid out
in increments annually over up to 10 years. HHS would work to identify
critical-need infections, desirable characteristics of eligible
products, establish values for contracts, ensure reliable supply
chains, facilitate appropriate patient access, and prioritize
antimicrobial stewardship plans to ensure appropriate use of newly
developed products. Sponsor revenue from Federal insurance programs for
the selected products would be subtracted from the annual contractual
payment.
medicare coverage for medical devices
Question. Last November Senator Hassan and I led a letter to the
Centers for Medicare and Medicaid Services (CMS) signed by eight other
Senators expressing our strong support for the timely creation of a new
Medicare Coverage for Innovative Technologies (MCIT) rule. Innovative
medical technologies improve the quality of life for Americans
experiencing disabilities, injuries, or chronic conditions. A new rule
would ensure that Medicare patients have access to new and innovative
medical technologies soon after they are cleared by the Food and Drug
Administration. In our letter, my colleagues and I encouraged CMS to
continue ongoing efforts to develop a flexible coverage pathway and
improve access to innovative devices while addressing operational and
patient protection concerns raised during the MCIT comment process. We
stated that CMS should move forward with a pathway for coverage that
allows for collection of appropriate evidence, if necessary. Finally,
we urged CMS to move quickly in issuing a new proposed rule.
The Office of Information and Regulatory Affairs regulatory
calendar now lists a Q3 target date for a new proposed rule listed as
Transitional Coverage for Emerging Technologies (CMS-3421) that would
establish the criteria for an expedited coverage pathway to provide
Medicare beneficiaries with faster access to innovative and beneficial
technologies. Can you assure us that CMS will propose a new rule in the
third quarter of 2022 that will lead to expedited coverage of
innovative and demonstrably beneficial medical technologies?
Answer. CMS remains committed to expanding access to health-care
coverage and services, including new, innovative treatments when they
are safe and appropriate. CMS rescinded the Medicare Coverage of
Innovative Technology and Definition of ``Reasonable and Necessary''
(MCIT/R&N) final rule because of concerns that the provisions in the
final rule may not have been sufficient to protect Medicare patients.
By rescinding this rule, CMS will take action to better address those
safety concerns in the future.
Improving and modernizing the Medicare coverage process continues
to be a priority for HHS and we remain committed to providing
stakeholders with more transparent and predictable coverage pathways.
CMS intends to explore coverage process improvements that will enhance
access to innovative and beneficial medical devices in a way that will
better suit the health-care needs of people with Medicare. This will
also help to establish a process in which the Medicare program covers
new technologies on the basis of scientifically sound clinical
evidence, with appropriate health and safety protections in place for
the Medicare population. CMS is working as quickly as possible to
advance multiple coverage process improvements that provide an
appropriate balance of access to new technologies with necessary
patient protections. As part of this effort, CMS is conducting several
listening sessions to learn about stakeholders' most pressing
challenges and to receive feedback from stakeholders about which
coverage process improvements would be most valuable. HHS looks forward
to hearing your feedback as we move forward with our efforts.
______
Questions Submitted by Hon. Ben Sasse
covid funding and policies
Question. Can you elaborate on why the administration's request for
supplemental COVID funding has shifted so many times? Which programs
need immediate funding now in order to continue?
Answer. The administration's supplemental request, which was
formally submitted to Congress on March 2, 2022, is $22.5 billion for
the COVID-19 response, of which $18.25 billion is for the U.S.
Department of Health and Human Services (HHS). This request is to
support immediate needs to avoid disruption to ongoing COVID response
efforts. Already, the administration has had to ramp down critical
programs that care for and protect people from COVID-19. For example,
the Health Resources and Services Administration's COVID-19 Uninsured
Program and Coverage Assistance Fund are no longer accepting claims due
to a lack of sufficient funds. This program was unable to accept claims
for testing and treatment as of March 22nd and claims for vaccines on
April 5th.
This $22.5-billion supplemental request will cover immediate needs
for tests, treatments and vaccines, investments in research and
development of next-
generation vaccines, and responding globally, including getting more
shots in arms around the world. The Federal Government does not have
adequate resources to purchase enough booster vaccine doses for all
Americans, if additional doses are needed. The shortages will be even
more acute if we need a variant-specific booster vaccine, since we will
not have any existing supply.
Question. The White House recently said that it has $300 billion
left in COVID-19 relief funding, with $60 billion of that unallocated.
Can you explain why this funding can't be used for these programs?
Answer. I am unaware of these statements or what these specific
figures refer to. HHS is using remaining COVID-19 supplemental funding
to provide lifesaving vaccines, therapeutics, and diagnostics, relief
to providers, support for public health, and other elements of the
response. HHS will soon exhaust available funding for buying antivirals
and vaccines, continuing ongoing clinical trials, providing tests, and
supporting the Center for Disease Control and Prevention's ongoing
operational costs. Without additional supplemental funding, the Federal
Government does not have adequate resources to purchase enough booster
vaccine doses or lifesaving antivirals. The shortages will be even more
acute if we need a variant-specific booster vaccine or if a variant
were to render our therapeutics ineffective.
Question. Could this issue be solved through Congress giving your
agency more flexibility in how existing funds are spent, rather than
allocating new funding? If not, can you explain why?
Answer. No. Although sufficient flexibility is necessary for HHS to
be adequately responsive to the changing dynamics of the pandemic, HHS
plans to exhaust all remaining resources for buying antivirals, other
therapeutics, and vaccines, continuing ongoing clinical trials,
providing tests, and supporting CDC's ongoing operational costs. Our
immediate needs are not hindered by a lack of flexibility but because
of a lack of adequate resources.
Question. When it comes to funding therapeutics, is there a plan
for the administration to transition out of being the sole purchaser
and distributor and instead allow these products on the commercial
market in the coming months?
Answer. To date in the COVID-19 response, the U.S. Department of
Health and Human Services (HHS) has supported efforts to ensure
vaccines are available to all States and communities. As of April 1,
2022, HHS has procured approximately 2 billion vaccines and 10.4
million therapeutics and has provided these resources to States and
territories at no cost. As Congress fails to continue to fund these
efforts, the Department is thinking through courses of action to
support the transition away from Federal acquisition. There are a
number of limitations, however, including licensure of products,
congressional statute, and insurance regulations. Let me be clear, the
administration's top priority is continued and equitable access to
these lifesaving vaccines. 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.
Question. When will the administration release COVID vaccines to
routine distribution channels to permit innovative multi-jurisdictional
strategies to increase vaccination, such as occupational health
activities of companies with employees in multiple States?
Answer. As noted in the response to the previous question, many
factors remain for transition vaccine to routine distribution
channels--including possible congressional action on our funding
request. We look forward to working with Congress to ensure continued
and equitable access to these lifesaving vaccines.
Question. While widespread vaccination has been crucial in limiting
severe illness and death, we also know that in rare cases the COVID-19
vaccines have led to extreme and lasting side effects, including
tinnitus and myocarditis. Is there money in the President's budget to
study these side effects and potential treatments for them? How
widespread is the data collection on this issue and how can Congress be
helpful?
Answer. Beyond base funding to support safety monitoring of routine
vaccinations, CDC's FY 2023 President's budget request includes
additional proposed funding for immunization safety to enhance existing
safety systems and networks through two separate legislative proposals:
Pandemic Preparedness Early Warning and Situational Awareness
activities and Vaccines for Adults budget initiative.
Additional funding under the Pandemic Preparedness: Early Warning
and Situational Awareness activities would be allocated for immediate
priorities like enhancements to the Vaccine Adverse Events Reporting
System (VAERS); sustaining the Vaccine Safety Datalink (VSD) sites,
adding more sites to increase the geographic and demographic diversity
of the VSD study population, and further studies on vaccine adverse
events in pregnant women; and expanding the Clinical Immunization
Safety Assessment Project (CISA) to increase timeliness, improve
clinical consultations for providers with questions on adverse events,
and expand efforts to analyze emerging vaccine issues (e.g.,
myocarditis, TTS, etc.) with experts specializing in fields relevant to
vaccine safety.
Additional funding as part of the Vaccines for Adults budget
initiative would expand routine and COVID-19 vaccination efforts for
adults to protect more Americans from preventable diseases.
As of March 2022, approximately 800,000 U.S. reports have been
submitted to VAERS after COVID-19 vaccination. Through follow-up,
including medical record reviews, as of March 10, 2022, CDC and FDA
have verified 1,367 reports of myocarditis or pericarditis with a
majority of these occurring following mRNA COVID-19 vaccines,
particularly in male adolescents and young adults. Understanding long-
term health effects is critically important to explaining the risks and
benefits of COVID-19 vaccination to the public and informing clinical
guidance. Therefore, CDC is conducting surveys of patients (or their
parents or guardians) and health-care providers to gather information
about myocarditis after mRNA COVID-19 vaccination.
The FY 2023 President's budget includes $81.7 billion in mandatory
funding over 5 years across the Office of the Assistant Secretary for
Preparedness and Response (ASPR), Centers for Disease Control and
Prevention (CDC), National Institutes of Health (NIH), and Food and
Drug Administration (FDA) to support President Biden's plan to
transform U.S. capabilities to prepare for and respond rapidly and
effectively to future pandemics and other high consequence biological
threats. This investment will fund transformative improvements in our
capabilities to prevent, detect, and respond to emerging biological
catastrophes.
The additional funding requested in the budget for HHS will help
transform our capability to rapidly produce and deliver countermeasures
against pandemics and other biological threats; strengthen our public
health infrastructure and early warning capabilities; invest in basic
research to enable an effective response to novel pandemics and
biological threats; modernize and streamline our regulatory
infrastructure; and, advance biosafety and biosecurity in the United
States and globally to prevent biological incidents.
Question. Cases are steadily declining each week, all States are
now seeing their lowest level of cases since last July, and
hospitalizations have decreased 33 percent. Given all of this, what is
the rationale for a continued ``public health emergency'' designation?
What numbers would the U.S. have to hit for it to end?
Answer. Based on the level of COVID-19 cases in communities across
the Nation, Secretary Becerra renewed the PHE on January 14, 2022, for
up to an additional 90 days. The determination to renew the PHE ensures
response efforts can continue at the level needed to address the
ongoing impact of the virus. HHS will continue to evaluate the
infection rate of COVID-19 and will modify the PHE, as needed. We have
indicated that we would provide a 60-day notice prior to removing the
PHE.
Question. In your hearing a few weeks ago before the House
Appropriations Subcommittee, you said that title 42, the policy used to
restrict immigration at our borders due to the public health risk to
Americans, would remain in place as long as there is reason and
justification. The next day, the administration announced the end of
title 42, saying that migrants at our Southern border have ``ceased to
be a serious danger to public health.'' How are you working with your
counterparts at DHS and other agencies to handle what will likely be a
large surge in migration as a result of the termination of this policy?
Answer. CDC has provided, and will continue to provide, technical
guidance to the U.S. Department of Homeland Security (DHS) and other
interagency partners to help prevent the transmission of COVID-19 and
other communicable diseases among the staff and migrants in Border
Patrol stations and other congregate facilities for immigration
processing. CDC's technical assistance and guidance have enabled DHS to
implement additional COVID-19 mitigation protocols, such as a program
for providing COVID-19 vaccinations to age-eligible migrants. Please
contact DHS for more information regarding this program and other DHS-
led COVID-19 mitigation efforts.
We note that the CDC Order and Termination are subjects of ongoing
litigation in multiple jurisdictions. CDC cannot comment on pending
litigation; however, we acknowledge that judicial actions may impact
the implementation of the termination.
unaccompanied children program
Question. The budget also requests $4.9 billion for the
Unaccompanied Children program, a more than $3-billion increase from FY
2021 when less than $2 billion was requested.
Is the program currently housing more than double the number of
children as it was previously?
Answer. Though the number of UC in ORR care has declined
significantly, from nearly 20,000 in April 2021 to an anticipated
10,000 in April 2022, referrals to the program continue to be higher
than historical patterns. In FY 2021, ORR received more than 122,000
referrals, the highest number of referrals in the UC program's history,
especially compared to FY 2020 when ORR received 15,000 referrals. As a
specific point of comparison, ORR received referrals for 1,530 children
in October 2020, but received 19,131 referrals in April 2021.
Question. What is the current number of children in HHS custody?
Answer. As of April 5, 2022, there are 10,370 children in ORR care.
Question. Will these funds be used to support the children without
a sponsor who end up in the U.S. foster care system?
Answer. Unaccompanied children are not placed in the U.S. domestic
foster care system. ORR funds a network of programs, which includes
ORR-operated transitional and long-term foster care programs. ORR
provides long term foster care placement for children who are expected
to have a protracted stay in ORR custody because they have no viable
sponsor. For additional information regarding placements in long term
foster care, please see ORR Policy Guide section 1.2.6.
Unaccompanied Refugee Minors are served by the Unaccompanied
Refugee Minors Program (URM), which is distinct from the Unaccompanied
Children (UC) program.
Question. What is your plan to strengthen oversight of this
program, which has been reported to detain children in CBP facilities
for 100+ hours on average and to occasionally lack stringent oversight
when vetting sponsor placements for minors?
Answer. To be clear, ORR does not detain children in U.S. Customs
and Border Protection (CBP) facilities. Children in CBP facilities are
in the custody of DHS until they are referred to ORR care. By statute
(6 U.S.C. 279; 8 U.S.C. 1232(b)), Federal agencies with custody of
unaccompanied children, as defined, must transfer such children to HHS
within 72 hours, absent exceptional circumstances. When DHS (and in
rare circumstances other Federal agencies) refer UC to ORR's care, the
children are transported to an ORR-funded care provider, typically a
State-licensed shelter, group home, or foster care home.
The extended holding period for children in CBP facilities last
spring and summer was due to the drastic increase in UC arrivals at the
southern border. For its part, ORR responded by mobilizing additional
capacity through emergency intake sites (EIS) and one influx care
facility (ICF). As a result, children have been moved out of CBP
custody promptly, and on average children have been spending less than
72 hours in DHS custody since spring of 2021.
Once a child is placed into ORR care, ORR works to place the child
with a vetted sponsor, usually a parent or a close relative who can
care for the child's physical and mental well-being while the child's
immigration case is adjudicated.
ORR's safe and timely release process includes several steps to vet
sponsors: the identification of sponsors; sponsor application;
interviews; and the assessment of sponsor suitability, including
verification of the sponsor's identity and relationship to the child.
ORR requires a background check of all potential sponsors and their
adult household members, as appropriate. In some cases, ORR requires a
home study be performed prior to releasing a child. A home study
consists of interviews, a home visit, and a written report containing
the home study case worker's findings. A home study assesses the
potential sponsor's ability to meet the child's needs, educates and
prepares the sponsor for the child's release, and builds on the sponsor
assessment conducted by the care provider staff to verify information
gathered during that process. See ORR Policy Guide section 2.2 for more
details on the sponsor application process.
In addition, all children released to a sponsor receive a Safety
and Well-being
Follow-Up Call. For any case requiring a home study, ORR assigns a
post-release service provider to provide follow up services for the
child. Additionally, ORR assigns post-release services to UC with
mental health or other physical needs who could benefit from the
ongoing assistance. Currently, ORR is in the early phases of
implementing a plan to expand PRS, with the goal of eventually being
able to serve all children who are released from ORR care, as well as
to enhance the services provided, as resources allow
hyde amendment/abortion policy
Question. For the second year, the administration failed to include
the Hyde Amendment in its budget request. I am obviously strongly
opposed to this decision and to the radicalization we have seen in your
party from ``safe, legal, and rare'' to what we see today.
Can you elaborate on the decision-making process that led to the
elimination of the Hyde Amendment?
Answer. The Hyde Amendment is a discriminatory policy that reduces
access to health care. Everyone, no matter where they live, how much
money they make, or how they are insured, should have access to the
health care they need. Ultimately, Congress passes laws and so the Hyde
Amendment still exists in the law, and HHS will continue to follow the
law.
mifepristone
Question. I am also disappointed with the FDA's decision to
permanently end the in-person requirement for dispensing the abortion
pill, mifepristone.
Are you able to share the number of severe, life-threatening, and
fatal adverse events that have taken place as a result of chemical
abortions?
Answer. In December of 2021, FDA posted a summary of reports
received by FDA of adverse events, including deaths, that occurred
among patients who had taken mifepristone for medical termination of
pregnancy. This summary is publicly available at the following link:
https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-
and-providers/questions-and-answers-mifeprex, and also is available
directly at: https://www.fda.gov/media/154941/download. The adverse
events cannot with certainty be causally attributed to mifepristone
because of concurrent use of other drugs, other medical or surgical
treatments, co-existing medical conditions, and information gaps about
patient health status and clinical management of the patient. FDA has
reviewed this information and did not identify any new safety signals.
Question. Has there been an uptick in hospitalizations, deaths, and
adverse events related to chemical abortion since tele-prescribing
began 2 years ago?
Answer. FDA routinely monitors post-marketing safety data for
approved drugs through adverse events reported to the FDA Adverse Event
Reporting System (FAERS) database, through the agency's review of
published medical literature, and when appropriate, by requesting
applicants submit summarized post-marketing data. For FDA's recent
review of the Risk Evaluation and Mitigation Strategy (REMS) for
mifepristone for medical termination of early pregnancy (also referred
to as the Mifepristone REMS Program), the agency searched the FAERS
database, reviewed the published medical literature for post-marketing
adverse event reports for mifepristone for medical termination of
pregnancy, and requested that the Applicants for Mifeprex and the
approved generic version of Mifeprex, mifepristone tablets, 200 mg,
submit a summary and analysis of certain adverse events. FDA's review
of this post-marketing data indicates there have not been any new
safety concerns with the use of mifepristone for medical termination of
pregnancy through 70 days gestation, including during the time when in-
person dispensing was not enforced. A more detailed discussion of this
review can be found in FDA's December 16, 2021, response to a Citizen
Petition that requested certain modifications to the Mifepristone REMS
Program and is available on regulations.gov.
Question. A recent report on the FDA's data on this issue found
that over 500 cases were described as ``uncodable'' with women ``lost
to follow-up,'' and a separate study of Medicaid claims data found that
more than 60 percent of chemical abortion-related emergency room visits
were misclassified as miscarriages.
Will you commit to working together to ensure that the FDA's data
collection is improved to keep moms and babies safe?
Answer. As it does for all approved drugs, FDA continues to closely
monitor the post-marketing safety data on Mifeprex and the approved
generic version of Mifeprex, mifepristone tablets, 200 mg. When FDA
receives new information regarding adverse events, the agency reviews
the new information and, as appropriate, takes necessary action,
including providing updates to health-care providers and their patients
so that they have information on how to use the drug safely.
conscience protections
Question. Last year, the Department of Justice announced that it
would be voluntarily dismissing a case against the University of
Vermont Medical Center that it had brought after the Office of Civil
Rights at your agency found that a nurse was forced to participate in
an elective abortion against his or her personal religious beliefs. As
you know, Federal law prohibits discrimination based on religion, and
conscience protections ensure that no medical practitioner can be
compelled to perform or assist in abortions.
Did the DOJ dismiss this case at your urging or the urging of other
top officials at HHS?
Can you explain to me how you believe this incident was not a
direct violation of Federal law?
Do you support protecting conscience rights when it comes to
medical practitioners and performing abortions?
Answer. As stated in our letter to the University of Vermont
Medical Center, ``OCR takes seriously its role in protecting the rights
of medical providers, including those protected by Federal conscience
laws.''\12\ HHS will continue to ensure the statutes protecting
providers are applied in accordance with applicable law.
---------------------------------------------------------------------------
\12\ Letter from Robinsue Frohboese, Acting Director and Principal
Deputy, Office for Civil Rights, U.S. Department of Health and Human
Services, to David Gacioch (July 30, 2021), at 2, https://www.hhs.gov/
conscience/conscience-protections/uvmmc-letter/index.html.
Question. Can you explain your decision to revoke the Conscience
and Religious Freedom Division's independent ability to investigate
---------------------------------------------------------------------------
these claims?
Answer. As stated in OCR's letter to the University of Vermont
Medical Center, ``Based on these subsequent legal developments and
concurrent with the Department of Justice filing today, we are
withdrawing the August 28, 2019 [Notice of Violation] and will continue
to evaluate the underlying complaint. OCR takes seriously its role in
protecting the rights of medical providers, including those protected
by Federal conscience laws. We are taking these actions to ensure the
statutes protecting providers are applied in accordance with applicable
law.''
______
Prepared Statement of Hon. Mike Crapo,
a U.S. Senator From Idaho
Thank you, Mr. Chairman, and thank you, Secretary Becerra, for
being here today.
Our Federal health-care programs face a range of pressing
challenges, which demand serious solutions. Today's hearing provides a
crucial opportunity to highlight both shared priorities and concerns
with respect to the proposals put forth by the President.
As part of the Cancer Moonshot initiative, the administration has
rightly acknowledged the value of multicancer early detection tests,
which have the potential to boost the cancer survival rate while
driving down costs. Earlier this Congress, I reintroduced bipartisan
legislation to ensure Medicare coverage for these screening tools, and
I look forward to working with you, Secretary Becerra, to move this
bill across the finish line. The budget proposal's focus on mental
health also offers potential for common ground.
Unfortunately, other aspects of the budget request raise
substantial questions. It is imperative that we work now to keep
Medicare strong, not only for current enrollees, but also for future
generations. The Medicare trustees have repeatedly cautioned that the
program's financial shortfalls will require legislative action, with
the hospital insurance trust fund projected to reach insolvency in
2026.
We have yet to receive this year's trustees report, but the
President's budget includes no proposals to shore up the trust fund's
solvency. In fact, the document contains virtually no sources of
Medicare savings at all, instead opting for a long list of coverage
expansions, often with no cost estimates.
Proposing dozens of new spending policies with no sense of their
budgetary effects risks deepening the deficit and exacerbating
inflation. A similar pattern persists for the budget request's Medicaid
provisions, which would add billions in new spending without any
meaningful cost-saving reforms.
Compounding these onerous impacts, the budget includes a
placeholder for a reckless tax-and-spending package, presumably the
nearly $5-trillion, House-passed Build Back Better Act that was
rejected on a bipartisan basis last year and across this country. The
government price controls, Obamacare subsidy hikes, and other misguided
policies included in that bill would intensify the hardships many
Americans currently face.
Under the package's price controls, we would inevitably see fewer
cutting-edge treatments and cures, higher launch prices for new drugs,
and a drastic decline in innovative R&D, handing the Chinese Communist
Party a competitive edge. Long-term Obamacare subsidy expansions,
meanwhile, would double down on skyrocketing Federal spending and force
taxpayers to fund coverage for Americans with six-figure salaries.
These policies would worsen the economic outlook for working
families. By continuing to push forward this problematic agenda, the
proposed budget has missed a key opportunity to address urgent issues
and needs.
As States and health-care providers across the country look to
budget for the year ahead, uncertainty abounds. The complex layers of
flexibilities and coverage mandates tied to the public health emergency
necessitate clear and comprehensive communication and accounting,
particularly as stakeholders attempt to map out the path to post-
pandemic normalcy. Without greater transparency, both for Congress and
for the Nation, this process could prove unpredictable and needlessly
costly.
Coverage dynamics, for instance, will likely be volatile at the end
of the public health emergency, yet this budget provides no plan for
transitions in care.
Last year's $1.9-trillion partisan spending bill suffered from poor
planning and prioritization, with only around 1 percent of the
package's funding directed to vaccines and therapeutics. This year's
budget request provided a chance to chart a more thoughtful return to
normalcy, continuity, and fiscal responsibility. Disappointingly, the
document does not rise to that occasion.
Secretary Becerra, I look forward to engaging with you on these and
other issues in the months ahead, particularly with respect to
telehealth, which continues to enjoy broad bipartisan support.
Thank you again for being here today, and thank you, Mr. Chairman.
______
Prepared Statement of Hon. Ron Wyden,
a U.S. Senator From Oregon
The Finance Committee meets this morning with Secretary Becerra to
discuss the year ahead for the Department of Health and Human Services.
There's a lot to cover, so I'll quickly tick through a handful of
issues.
First, on telehealth. This committee began to open the door to
telehealth in Medicare in the CHRONIC Care Act in 2017. Then in 2020,
we pushed to include telehealth services in the CARES Act. In
implementing the law, Medicare decided to also cover telehealth
delivered audio-only on a temporary basis during the pandemic. That's
been a health care game-changer for people across the country,
particularly in rural areas. In this year's appropriations bill,
Senator Crapo and I pushed to extend the audio-only flexibility beyond
the public health emergency.
There is bipartisan interest in building on that progress on a
permanent basis and making sure that the clock doesn't get turned back
on patients who've come to rely on telehealth for basic services. I'm
sure that issue will be part of our discussion today.
Second, Democrats and the administration are committed to
protecting our bedrock health-care programs--strengthening the
Affordable Care Act, upholding the Medicare guarantee. Republicans have
other ideas.
Senator Scott, the campaign visionary for Senate Republicans,
recently proposed phasing out Medicare in 5 years. I'd like to know how
America's 60-year-olds feel about that. And Senator Johnson has doubled
and tripled down on the same old crusade: repealing the Affordable Care
Act. He says that Republicans should be preparing their repeal bill now
to have it ready to go whenever they next take power. If it looks
anything like it did last time, it'll gut health care for tens of
millions and shower tax handouts on the wealthy. In my view, that's not
what Americans are interested in seeing right now.
The biggest concern going today for millions of families in Oregon
and all across the country is the rising cost of living. Bringing down
health-care prices and protecting Americans from getting clobbered by
huge bills is one of the best ways for Congress to take some of the
pressure off their pocketbooks.
A couple of areas to highlight. For one, millions of Americans are
getting a better deal on health insurance this year because of the
rescue plan Democrats passed in March of 2021. Monthly premiums for
Americans who get insurance on the individual market fell by 22 percent
this year--adding up to hundreds of dollars or more over 12 months.
People across all income levels saved money. Six million new consumers
got coverage.
Go back a few decades and Republicans would be shouting from the
mountaintops about the incredible success of the private marketplace at
work. Not so in 2022--these days, every Republican has gone on record
against the tax credits that made that success possible. If the
Republicans have their way, millions of Americans are going to get
whacked by higher insurance premiums in 2023. That cannot be allowed to
happen. Democrats must keep those savings going.
The administration and Democrats in Congress are also in lockstep
when it comes to bringing down prescription drug prices. For too many
Americans, every trip to the pharmacy counter means getting mugged by
drug companies. Instead of using the bargaining power of more than 60
million American seniors to get lower drug prices, Medicare's hands are
tied behind its back.
Changing that by giving Medicare the authority to negotiate a
better deal for brand-name drugs is the single most important reform on
offer. Democrats also have a plan to cap copays for insulin at $35 a
prescription and set an out-of-pocket cap for seniors' prescriptions in
Medicare Part D at $167 per month. The plan would also create a tough
new price-gouging penalty for drug companies that increase prices
faster than inflation. This plan would save money for patients in
Medicare and in the private market, and it would also save taxpayers
billions every year.
Getting a better deal on health insurance and prescription drugs--
those are the kinds of savings that millions and millions of Americans
need desperately right now. Congress must step up and deliver them.
Finally, this committee is working hard on a bipartisan basis to
guarantee that every American can finally get the mental health care
they need when they need it. The budget includes smart proposals to
help make that a reality, particularly within Medicare and Medicaid:
getting rid of caps on Medicare coverage for care in a psychiatric
hospital; adding Medicare coverage for sessions with a therapist or
counselor; waiving cost sharing for up to three mental health visits a
year in Medicare and private insurance; and permanently expanding
nationwide Medicaid funding for Certified Community Behavioral Health
Clinics, which Senator Stabenow has long championed.
These proposals from the budget could open doors to treatment for a
lot of people who are struggling to connect with mental health
providers today, or people who could face a crisis in the future.
Members on both sides of this committee are laser-focused on mental
health care, and we look forward to working with the administration on
these issues.
______
Rebuilding Title X: New Regulations for the
Federal Family Planning Program
By Brittni Frederiksen, Ivette Gomez, and Alina Salganicoff
November 3, 2021
On October 4, 2021, the Biden Administration released new final
regulations for the federal Title X family planning program. The new
regulations replace those issued by the Trump Administration in
2019,\1\ which made significant and well documented \2\ changes to the
Title X program leading to a significant reduction in the size of the
Title X network and the number of low-income and uninsured clients
served by the program. This brief presents new state-level data on the
status of the Title X network on the eve of the implementation of the
new regulations and summarizes the impact of Trump era regulations on
the number of clients served and status of participation by clinics
across the country.
---------------------------------------------------------------------------
\1\ https://www.federalregister.gov/documents/2019/03/04/2019-
03461/compliance-with-statutory-program-integrity-requirements.
\2\ https://www.kff.org/womens-health-policy/issue-brief/current-
status-of-the-title-x-network-and-the-path-forward/.
---------------------------------------------------------------------------
The Impact of the 2019 Trump Regulations
The 2019 Trump Administration regulations substantially diminished the
Title X family planning network by disqualifying family planning
clinics with co-located abortion services and disallowing the provision
of abortion referrals to clients that wanted them. In its 2020 Family
Planning Annual Report,\3\ the federal Office of Population Affairs
(OPA) documented the impact of both the Trump Administration's
regulations and the pandemic on the number of clients they served, as
well as the change in the number of grantees and clinic sites from 2018
to 2020 (Table 1). In this two-year period, the number of clients
served fell from 3.9 million to 1.5 million people. The report
estimated that the Trump Administration's final rule accounted for
nearly two-thirds (63%) of the precipitous reduction in the number of
family planning clients served while the COVID-19 pandemic accounted
for one third of the falloff.
---------------------------------------------------------------------------
\3\ https://opa.hhs.gov/sites/default/files/2021-09/title-x-fpar-
2020-national-summary-sep-2021.pdf.
Table 1: Changes in the Title X Network from 2018 to 2020
------------------------------------------------------------------------
2018 2019 2020
------------------------------------------------------------------------
Clients served 3.9 million 3.1 million 1.5 million
------------------------------------------------------------------------
Family planning visits 6.5 million 4.7 million 2.7 million
------------------------------------------------------------------------
Grantees (receive funding from 99 100 75
HHS OPA)
------------------------------------------------------------------------
Sub-recipients (receive 1,128 1,060 867
funding from grantees and can
distribute to clinic sites or
provide services themselves)
------------------------------------------------------------------------
Clinic sites (receive funding 3,954 3,825 3,031
from grantees or sub-
Precipients)
------------------------------------------------------------------------
SOURCE: Title X Family Planning Annual Report 2020 National Summary,
https://opa.hhs.gov/sites/default/files/2021-09/title-x-fpar-2020-
national-summary-sep-2021.pdf.
With the large exodus of clinics from the Title X program in summer of
2019, there are still five states without any Title X funded clinic
sites: Oregon, Washington, Vermont, Maine, and Hawaii, while New York
currently has only two sub-recipient sites. Another seven states,
including New York, have Title X clinic networks that are currently
operating at less than 25% of their original capacity. Based on our
analysis of OPA's Title X Family Planning Directories, 36 states have
experienced a decrease in participating Title X clinics from June 2019
to August 2021, while OPA's Family Planning Annual Reports between 2018
and 2020 show 49 states and DC have seen a reduction in clients ranging
from 2%-100%, with a median reduction in clients of 52%.
A small number of entities have rejoined the Title X network in the
past year. One of Utah's two grantees, Utah Navajo Health System,
rejoined the Title X program in July 2020 as a sub-recipient under
Arizona's grantee, Arizona Family Health Partnership. Maryland
Department of Health rejoined the program in October 2020 after the
state of Maryland was granted a permanent injunction against enforcing
the 2019 Title X Final Rule. Most of the Planned Parenthood clinics
left the Title X Program after the Trump Administration's Rule became
final though few are now in the program, including those in Maryland,
Washington DC, and Missouri.
The Trump Administration Final Rule allowed ``non-traditional'' Title X
grantees to join the network and some of these grantees are no longer
part of the program under the Biden Administration. The Trump
Administration regulations extended federal family planning funds to
organizations that only offered their clients fertility awareness or
abstinence options. The new regulations do not qualify them to
participate as grantees if they do not offer a broader range of
contraception methods to their clients. Notably, the Obria Group, Inc.,
a Christian organization based in Southern California that did not
provide contraceptive services based on religious objections to
hormonal contraception, left the Title X program in April 2021. Another
Christian-based organization, Beacon Christian Community Health Center,
which joined the Title X network as a New York grantee in October 2018,
left the Title X program in April 2021 as well. Two of the three new
Title X grantees that joined the Title X program under the Trump
Administration that are not religiously based, City of El Paso in Texas
and Osceola Community Health Services in Florida, remain in the
program.
Key Aspects of the Final Biden Administration's Title X Regulations
The new Biden regulations \4\ restore many aspects of the program that
were removed through the Trump Administration regulations, including:
---------------------------------------------------------------------------
\4\ https://www.federalregister.gov/documents/2021/10/07/2021-
21542/ensuring-access-to-equitable-affordable-client-centered-quality-
family-planning-services.
---------------------------------------------------------------------------
Allowing co-located abortion services and abortion referrals.
Requiring clinics that are not able to provide clients with a
broad range of family planning methods to provide a prescription or
referral to the client if requested.
Added confidentiality protections for adolescents--clinics may
not require consent of a parent or guardian for the provision of
services and cannot notify a parent or guardian before or after
provision of any services.
The regulations have also added new provisions to the program,
including:
Adding telehealth as an option for providing medical services in
addition to in-person care.
Requiring family planning projects to provide services in a
matter that is client-centered, culturally and linguistically
appropriate, inclusive, and trauma-
informed; protects the dignity of the individual; and ensure equitable
and quality service delivery consistent with a nationally recognized
standard of care.
Adding a new funding criterion--the ability of the applicant to
advance health equity.
The final rules will be effective November 8, 2021, and clinics will
once again be able to provide their clients with the care that meets
the quality standards established by the CDC and OPA,\5\ including
providing non-directive pregnancy options counseling with referrals for
prenatal care, adoption services, or abortion services and confidential
services for adolescents, but it will take time to restore the network
of providers. On October 25, 2021, the state of Ohio, joined by 11
other states (AL, AZ, AK, FL, KS, KY, MO, NE, OK, SC, WV), filed a
lawsuit \6\ in the U.S. District Court for the Southern District of
Ohio against HHS to block the implementation of the Biden
Administration's regulations. These states claim the final regulations
violate Section 1008 of the Public Health Service Act that says none of
the funds appropriated under Title X can be used in programs where
abortion is a method of family planning. The litigants claim that by
reinstating the regulations that allow co-located abortion services and
require participating providers to offer referrals for abortions to
clients who seek them, that HHS is not in compliance with the intent of
the law. The states are requesting a ruling as soon as practicable and
no later than December 31, 2021. If the Court does not rule before
November 8th, the Biden regulations will become effective.
---------------------------------------------------------------------------
\5\ https://opa.hhs.gov/sites/default/files/2020-10/providing-
quality-family-planning-services-2014_1.pdf.
\6\ https://www.ohioattorneygeneral.gov/Files/Briefing-Room/News-
Releases/Title-X-PI-Motion.aspx.
If the final regulations remain in effect, additional funding that can
be extended to grantees that left the network is not anticipated until
Spring of 2022 after the grant applications due January 11, 2022 \7\
are reviewed and approved. Funding will likely be awarded by April 1,
2022. Grantees that are still part of the Title X program can bring
clinics back into their network if they have current funding available.
Current grantees' three-year grant cycle ends March 31, 2022.
---------------------------------------------------------------------------
\7\ https://www.grants.gov/view-opportunity.html?oppId=334698.
In response to Texas' S.B. 8 law banning most abortions, HHS will award
additional funding to Texas' largest Title X grantee to meet an
increased demand for emergency contraception and family planning
services. OPA is also planning to award an additional $10 million
through a new funding opportunity entitled ``Funding to Address Dire
Need for Family Planning Services'' that will provide grants to Title X
entities that can demonstrate a need for additional funding for family
planning services due to either an influx of clients as a result of
Texas' S.B. 8 abortion ban or some other reason. A second funding
opportunity that OPA is planning on releasing will provide $45 million
in Spring 2022 to Title X grantees to expand and enhance their
telehealth infrastructure and capacity, which will be particularly
important given the ongoing COVID-19 pandemic and increased demand for
telehealth services.
Looking Forward
The final Biden Administration Title X regulations will make
significant changes to sites across the nation and allow clinics like
Planned Parenthood, which were formerly disqualified because they have
co-located abortion services or provide abortion referrals for
individuals who want them, to once again apply for federal support to
provide family planning services to low-income and uninsured
individuals. These regulations are being challenged by several states
by litigation that could take years to resolve. If fully implemented,
however, the real impact of the revised regulations will be when
federal funds become available to grantees and clinics to rejoin the
program and allow more low-income people to receive health services
from Title X sites. While many grantees and clinics that left the
network are anticipated to resume participation in the safety net
program, it remains to be seen whether all those grantees and providers
that left the program will apply to return. Some were able to obtain
state-level funding to bridge the loss of federal support. These
decisions will likely depend on whether states will continue to
subsidize their family planning providers or whether additional federal
funds will be needed to maintain and strengthen state family planning
networks and services in communities that have historically been served
by these providers.
``Rebuilding Title X: New Regulations for the Federal Family Planning
Program,'' Brittni Frederiksen, Ivette Gomez, and Alina Salganicoff,
published: November 3, 2021, https://www.kff.org/womens-health-policy/
issue-brief/rebuilding-title-x-new-regulations-for-the-federal-family-
planning-program/.
______
Communication
----------
Center for Fiscal Equity
14448 Parkvale Road, Suite 6
Rockville, MD 20853
[email protected]
Statement of Michael G. Bindner
Chairman Wyden and Ranking Member Crapo, thank you for the opportunity
to submit these comments for the record on the HHS FY 2023 Budget
Request.
There have been more than a few hearings this spring to set the stage
for the release of this budget. I will briefly restate some of our
comments. Links to our comments can be found on our Fiscal Equity blog
and YouTube channel. These hearings include:
Senate Finance: Behavioral Health Care When Americans Need It:
Ensuring Parity and Care Integration, March 30, 2022.
Ways and Means: America's Mental Health Crisis, February 2,
2022.
Finance: Mental Health Care in America: Addressing Root Causes
and Identifying Policy Solutions, June 15, 2021.
Ways and Means, Worker and Family Support: Improving Family
Outcomes through Home Visiting, March 16, 2022.
Ways and Means, Health: Bridging Health Equity Gaps for People
with Disabilities and Chronic Conditions, February 3, 2022.
Please also see our many Pandemic-related comments, which took the
Centers for Disease Control to task for not correctly assessing the
early symptoms of the virus. See especially:
Ways and Means, Health: The Path Forward on COVID-19
Immunizations, February 26, 2021.
We agree with the President's proposals to add funding to prepare for a
future pandemic and to fund the ARPA-H Cancer Moonshot. Discoveries
relating to the former will likely help the latter.
Part of ARPA-H is the funding for research on orphan drugs and the
lingering problem of their cost once research leads to product
development. In comments to Senate Finance on March 16th of this year,
we repeated our proposal in this area for NIH to retain ownership in
any such drug and contract out its further development and manufacture.
Keeping ownership in public hands ends the need for drug companies to
charge extreme prices or increase prices for its existing formulary to
fund development.
PhARMA would still make reasonable profit, but the government would eat
the risk and sometimes reap the rewards. NIH/FDA might even break even
in the long term, especially if large volume drugs which were developed
with government grants must pay back a share of basic research costs
and the attached profits, as well as regulatory cost.
On the pandemic, we urge that there be a public examination of lessons
learned--particularly mistakes. The largest mistake was to not identify
COVID-19 as being spread like a cold.
Subsequent variants identified sneezing and a runny nose as early signs
of the virus. This was true in the first round, but to save face, it
was not mentioned and is still not admitted. Job one of preparing for
the next coronavirus pandemic is to list cold or supposed allergy
symptoms as the signal to self-quarantine (if not be quarantined).
Donald Trump did not kill a million people. Trying to downplay original
symptoms did--which led to a loss of credibility among some
populations. This social aspect must also be explored--especially if
these populations are to comply with later instructions.
The President's proposals to expand behavioral health are most welcome,
although only a start. Replacing mental health facilities--as well as
policies which allow longer-term mandatory stays are what is needed--
including conditions whereby readmission to a more controlled
environment is automatic in the event of relapse or medication non-
compliance.
Such a change in the rules of the game will demand 50-state
cooperation, as local laws are impacted. The Department of Justice and
state and local police agency participation is also required. Reform
cannot only be for those with insurance--it must be for everyone.
Parity is not enough--and is impossible without not only more beds--but
more dedicated hospitals.
The Visiting Nurses program is worthy of expansion--not only in public
sector funding, but in the private sector as well. When my daughter was
born, a visiting nurse to screen for depression and help with lactation
coaching would have been a godsend, although we were lucky for generous
family leave policies and good health insurance through my wife's
employer. Health Insurance Reform will allow an even greater expansion
of the pilot program to all. I will come back to this shortly.
New mothers and their partners have unmet needs beyond the particular
programs listed in the House Budget Committee Summary. We cannot take
our eye off of the Child Tax Credit ball. It must be both refundable
and more generous. So that families are not simply living off of their
CTC, the minimum wage needs to go up--although with a higher Child
Credit a lower amount can be agreed to. Childcare subsidies are also as
essential now as they were last year.
We have attached a portion of our comments from last year having to do
with the Affordable Care Act, enacting a public option, how the issue
is related to Student Loan forgiveness (here's a clue--baselines) and
how to reform Medicaid and Medicare to remove the biggest Medicaid
contingent liability from state budgets.
Considering the problems getting Build Back Better over the line, I can
see where opening discussions on the Public Option and Medicare for All
might prove difficult--especially given the lack of agreement between
the relevant committees.
I hope I am not shocking anyone by saying this. With that said, it is
time for both CMS and the Budget and Revenue Committees to start
discussing what might be done in the next Congress on a bipartisan
basis.
Please allow me to offer questions for research and discussion:
Would a public option be more likely to pass if Affordable Care Act
surtaxes (SMI) were repealed?
What would be the impact on passage and operation of a public option of
ending pre-existing condition reform with automatic enrollment in the
public option, with subsidies, if coverage were denied?
How large would subsidies have to be to hold those who cannot get
insurance due to a pre-existing condition harmless?
Are Affordable Care Act deductibles and premiums too high? (It seemed
so to me when I had them and suffered a broken rib--for which the
provider was never paid).
Can a public option, or even the ACA as it exists, meet all of its
goals without either immigration reform or ending the prohibition on
covering undocumented workers?
To what extent is sick leave (Building Back Better), essential for the
ACA to really cut prices?
To what extent would the public option replace Medicaid?
Would reform be easier to pass if long-term care were funded as
Medicare Part E rather than being operated and funded by the States?
(This would also require 50-state cooperation).
What is the best way to fund a public option (or Medicare for All)? Is
some form of border adjustable goods and services tax better than a
payroll tax? Would an
employer-paid subtraction VAT be better?
SVAT would burden profits and would replace current funding of the
Affordable Care Act and the tax exclusion for employer-provided health
insurance. Corporate Income Taxes and Schedules C and F for Form 1040
would be replaced with this tax. See the second attachment for details.
How long would it take for insurance companies to deny anyone who is
sick coverage, thus forcing them into a subsidized public option? Would
this become Medicare for All, given that much private managed care,
Medicaid and Medicare Parts B and D or Part C are all offered by the
same list of providers, albeit with different copays?
Income Security is also in need of advanced study.
While Social Security 2100 is the school solution preferred by most
mainstream analysts, should some form of expanded employee ownership be
part of the solution?
To study this, HHS, the IRS and the Department of Labor--as well as
their authorizing committees--should look at how to expand employee
ownership.
The same bodies must also explore the impact of increasing the minimum
wage on benefit levels, assuming that any increase lead to a rebasing
of employment history.
What is the impact of crediting the employer contribution on an equal
dollar basis rather than as a match to the employee contribution?
Would rebasing income history with a higher minimum wage and an equal
dollar employer contribution end poverty among the low income elderly
and disabled? Is it a matter of degree? How much would the minimum wage
have to change to make a significant impact?
How would addressing such questions impact Social Security 2100?
Thank you for the opportunity to address the committee. We are, of
course, available for direct testimony or to answer questions by
members and staff.
Attachment One--HHS Budget FY 2022
We address the funding of the Affordable Care Act, the need for an
immediate COLA for retirees,funding the Social Security
Administration's non-fund costs and the idea of cost savings for Social
Security.
So far, the Administration has not yet addressed changes to the
Affordable Care Act, at least not publicly. We suggest that the
Committee ask the Secretary about any such plans.
At minimum, the individual and employer mandates, with associated
penalties, that were repealed must be restored. The President
campaigned on restoring and perfecting the Act, adding a public option.
We agree, although the public option need not be self supporting. It
must be subsidized through a broad based consumption tax. Such a tax
burdens both capital and wage income.
The current funding stream seems to have been designed to draw
opposition from wealthier taxpayers. It is an open secret that the
Minority does not oppose most of the Affordable Care Act (which was
designed by their own Heritage Foundation as an alternative to Mrs.
Clinton's proposals). Broaden the tax base to fund the program and the
nonsense on repeal will end.
The current funding stream from student loan initiation and interest,
which was included in the baseline, should also be ended. Graduates
(and non-graduates) with student loan debt cannot afford both their
loan payments and insurance payments under the Affordable Care Act.
When they apply for lower loan payments, which are always granted, they
face either a balloon interest payment or capitalized interest, which
makes their funding situation worse. No one should have to retire with
student load debt, yet quite a few soon will (or already have).
Forgive capitalized interest and apply any overpayments to principal.
There should not be a one-size-fits-all subsidy. Also, when payments
are deferred, return to the practice of deferring interest (or allow
debts to be discharged, at least partially, in bankruptcy).
To deal with these issues, whatever is budgeted for analytical support
in the Department should likely be doubled.
The following analysis comes from the Single Payer attachment that has
previously been provided. Because of the President's preference for
establishing the public option, we will repeat those analyses here.
Aside from a broader base of funding, other compromises are necessary
to enact a public option.
To set up a public option end protections for pre-existing conditions
and mandates. The public option would then cover all families who are
rejected for either pre-
existing conditions or the inability to pay. In essence, this is an
expansion of Medicaid to everyone with a pre-existing condition. As
such, it would be funded through increased taxation, which will be
addressed below. A variation is the expansion of the Uniformed Public
Health Service to treat such individuals and their families.
The public option is inherently unstable over the long term. The profit
motive will ultimately make the exclusion pool grow until private
insurance would no longer be justified, leading again to Single Payer
if the race to cut customers leads to no one left in private insurance
who is actually sick. This eventually becomes Medicare for All, but
with easier passage and sudden adoption as private health plans are
either banned or become bankrupt. Single Payer would then be what
occurs when insurance companies are bailed out in bankruptcy, the
public option covers everyone and insurance companies are limited to
administering the government program on a state by state basis.
The financing of the Affordable Care Act should be broadened. It should
neither be funded by the wealthy or by loan sharking student loan
debtors. Instead, it should be funded by an employer-paid consumption
tax, with partial offsets to tax payments for employer provided
insurance and taxes actually collected funding a Public Option (which
should also replace Medicaid for non-retirees). Medicaid for retirees
and Medicare should be funded by a border adjustable goods and services
tax, which should be broad based.
Why the difference? The goal is to not need a public option as
employers do the right thing and cover every worker or potential
worker. Using an employer based tax is an incentive to maximize
employee coverage. Medicare, however, is an obligation on society as a
whole.
State governments are under financial pressure as a result of the
pandemic, especially in the area of healthcare costs, most especially
for seniors in nursing homes who are ``dual eligibles.'' The heart of
President Reagan's New Federalism proposal was the transfer of state
Medicaid expenses to the federal government, largely to fund baby
boomers who would become dual eligible with time. Time is now up, or
will be shortly.
Welfare has been reformed, allowing state and federal governments to
save money--which was part of the New Federalism bargain that was not
accepted at the time. We will address this part shortly, but the irony
is that federal money was reduced without the second part of the trade-
off.
Finish the process and create Medicare Part E for low income disabled
and retirees. This will put investigation of nursing home conditions
into the federal sector. States have done a poor job in enforcement of
health and safety standards. It is time to make this a national
responsibility.
One way to increase benefits generally is to increase the minimum wage,
the higher the better, and rebase current benefits to consider such an
increase to be wage inflation. Such a change will fund itself, because
wages funding benefits will be increased across the board.
Attachment Two--Tax Reform, Center for Fiscal Equity, December 7, 2021
Individual payroll taxes. Employee payroll tax of 7.2% for Old-Age and
Survivors Insurance. Funds now collected as a matching premium to a
consumption tax based contribution credited at an equal dollar rate for
all workers qualified within a quarter. An employer-paid subtraction
value added tax would be used if offsets to private accounts are
included. Without such accounts, the invoice value added tax would
collect these funds. No payroll tax would be collected from employees
if all contributions are credited on an equal dollar basis. If employee
taxes are retained, the ceiling would be lowered to $100,000 to reduce
benefits paid to wealthier individuals and a $16,000 floor should be
established so that Earned Income Tax Credits are no longer needed.
Subsidies for single workers should be abandoned in favor of radically
higher minimum wages. If a $10 minimum wage is passed, the employee
contribution floor would increase to $20,000.
Wage Surtaxes. Individual income taxes on salaries, which exclude
business taxes, above an individual standard deduction of $100,000 per
year, will range from 7.2% to 57.6%. This tax will fund net interest on
the debt (which will no longer be rolled over into new borrowing),
redemption of the Social Security Trust Fund, strategic, sea and non-
continental U.S. military deployments, veterans' health benefits as the
result of battlefield injuries, including mental health and addiction
and eventual debt reduction.
Our proposed brackets have been increased from $85,000 to $100,000
because this is the income level at the top of the 80% of tax paying
households who earn the bottom third of adjusted gross income. Earners
above this level are considered middle class. Likewise, the top 1% of
income earners are at the $500,000 level, which will be used as the
start of the highest rate.
Asset Value-Added Tax (A-VAT). A replacement for capital gains taxes,
dividend taxes, and the estate tax. It will apply to asset sales,
dividend distributions, exercised options, rental income, inherited and
gifted assets and the profits from short sales. Tax payments for option
exercises, IPOs, inherited, gifted and donated assets will be marked to
market, with prior tax payments for that asset eliminated so that the
seller gets no benefit from them. In this perspective, it is the
owner's increase in value that is taxed. As with any sale of liquid or
real assets, sales to a qualified broad-based Employee Stock Ownership
Plan will be tax free. These taxes will fund the same spending items as
income or S-VAT surtaxes.
This tax will end Tax Gap issues owed by high income individuals. A 26%
rate is between the GOP 23.8% rate (including ACA-SM surtax) and the
Democratic 28.8% rate as proposed in the Build Back Better Act. It's
time to quit playing football with tax rates to attract side bets. A
single rate also stops gaming forms of ownership. Lower rates are not
as regressive as they seem. Only the wealthy have capital gains in any
significant amount. The de facto rate for everyone else is zero. For
now, however, a 28.8% rate is assumed if reform is enacted by a
Democratic majority in both Houses.
Subtraction Value-Added Tax (S-VAT). These are employer paid Net
Business Receipts Taxes. S-VAT is a vehicle for tax benefits, including
Health insurance or direct care, including veterans' health care
for non-
battlefield injuries and long term care.
Employer paid educational costs in lieu of taxes are provided as
either
employee-directed contributions to the public or private unionized
school of their choice or direct tuition payments for employee children
or for workers (including ESL and remedial skills). Wages will be paid
to students to meet opportunity costs.
Most importantly, a refundable child tax credit at median income
levels (with inflation adjustments) distributed with pay.
Subsistence level benefits force the poor into servile labor. Wages and
benefits must be high enough to provide justice and human dignity. This
allows the ending of state administered subsidy programs and
discourages abortions, and as such enactment must be scored as a must
pass in voting rankings by pro-life organizations (and feminist
organizations as well). To assure child subsidies are distributed, S-
VAT will not be border adjustable.
The S-VAT is also used for personal accounts in Social Security,
provided that these accounts are insured through an insurance fund for
all such accounts, that accounts go toward employee ownership rather
than for a subsidy for the investment industry. Both employers and
employees must consent to a shift to these accounts, which will occur
if corporate democracy in existing ESOPs is given a thorough test. So
far it has not. S-VAT funded retirement accounts will be equal-dollar
credited for every worker. They also have the advantage of drawing on
both payroll and profit, making it less regressive.
A multi-tier S-VAT could replace income surtaxes in the same range.
Some will use corporations to avoid these taxes, but that corporation
would then pay all invoice and subtraction VAT payments (which would
distribute tax benefits). Distributions from such corporations will be
considered salary, not dividends.
Invoice Value-Added Tax (I-VAT). Border adjustable taxes will appear on
purchase invoices. The rate varies according to what is being financed.
If Medicare for All does not contain offsets for employers who fund
their own medical personnel or for personal retirement accounts, both
of which would otherwise be funded by an S-VAT, then they would be
funded by the I-VAT to take advantage of border adjustability. I-VAT
also forces everyone, from the working poor to the beneficiaries of
inherited wealth, to pay taxes and share in the cost of government.
Enactment of both the A-VAT and I-VAT ends the need for capital gains
and inheritance taxes (apart from any initial payout). This tax would
take care of the low-income Tax Gap.
I-VAT will fund domestic discretionary spending, equal dollar employer
OASI contributions, and non-nuclear, non-deployed military spending,
possibly on a regional basis. Regional I-VAT would both require a
constitutional amendment to change the requirement that all excises be
national and to discourage unnecessary spending, especially when
allocated for electoral reasons rather than program needs. The latter
could also be funded by the asset VAT (decreasing the rate by from
19.5% to 13%).
As part of enactment, gross wages will be reduced to take into account
the shift to S-VAT and I-VAT, however net income will be increased by
the same percentage as the I-VAT. Adoption of S-VAT and I-VAT will
replace pass-through and proprietary business and corporate income
taxes.
Carbon Added Tax (C-AT). A Carbon tax with receipt visibility, which
allows comparison shopping based on carbon content, even if it means a
more expensive item with lower carbon is purchased. C-AT would also
replace fuel taxes. It will fund transportation costs, including mass
transit, and research into alternative fuels (including fusion). This
tax would not be border adjustable unless it is in other nations,
however in this case the imposition of this tax at the border will be
noted, with the U.S. tax applied to the overseas base..
Tax Reform Summary
This plan can be summarized as a list of specific actions:
1. Increase the standard deduction to workers making salaried income
of $35,000 and over, shifting business filing to a separate tax on
employers and eliminating all credits and deductions--starting at 7.2%,
going up to 28.8%, in $50,000 brackets.
2. Shift special rate taxes on capital income and gains from the
income tax to an asset VAT. Expand the exclusion for sales to an ESOP
to cooperatives and include sales of common and preferred stock. Mark
option exercise and the first sale after inheritance, gift or donation
to market.
3. Employers distribute the child tax credit with wages as an offset
to their quarterly tax filing (ending annual filings).
4. Employers collect and pay lower tier income taxes, starting at
$100,000 at 7.2%, with an increase to 14.4% for all salary payments
over $150,000 going up 7.2% for every $50,000 up to $250,000.
5. Shift payment of HI, DI, SM (ACA) payroll taxes to employers,
remove caps on employer payroll taxes and credit them to workers on an
equal dollar basis.
6. Employer paid taxes could as easily be called a subtraction VAT,
abolishing corporate income taxes. These should not be zero rated at
the border.
7. Expand current state/federal intergovernmental subtraction VAT to a
full GST with limited exclusions (food would be taxed) and add a
federal portion, which would also be collected by the States. Make
these taxes zero rated at the border. Rate should be 19.5% and replace
employer OASI contributions. Credit workers on an equal dollar basis.
8. Change employee OASI of 7.2% from $18,000 ($20,000 for $10 minimum
wage) to $100,000 income.are optional taxes for Old Age and Survivors
Insurance.
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