[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

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                 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

                              ----------                              


                         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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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?
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.

                                   [all]