[Senate Hearing 118-451]
[From the U.S. Government Publishing Office]
S. Hrg. 118-451
THE PRESIDENT'S FISCAL YEAR 2024
HEALTH AND HUMAN SERVICES BUDGET
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HEARING
BEFORE THE
COMMITTEE ON FINANCE
UNITED STATES SENATE
ONE HUNDRED EIGHTEENTH CONGRESS
FIRST SESSION
__________
MARCH 22, 2023
__________
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Finance
__________
U.S. GOVERNMENT PUBLISHING OFFICE
57-181--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 TIM SCOTT, South Carolina
SHERROD BROWN, Ohio BILL CASSIDY, Louisiana
MICHAEL F. BENNET, Colorado JAMES LANKFORD, Oklahoma
ROBERT P. CASEY, Jr., Pennsylvania STEVE DAINES, Montana
MARK R. WARNER, Virginia TODD YOUNG, Indiana
SHELDON WHITEHOUSE, Rhode Island JOHN BARRASSO, Wyoming
MAGGIE HASSAN, New Hampshire RON JOHNSON, Wisconsin
CATHERINE CORTEZ MASTO, Nevada THOM TILLIS, North Carolina
ELIZABETH WARREN, Massachusetts MARSHA BLACKBURN, Tennessee
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...................... 4
ADMINISTRATION WITNESS
Becerra, Hon. Xavier, Secretary, Department of Health and Human
Services, Washington, DC....................................... 6
ALPHABETICAL LISTING AND APPENDIX MATERIAL
Becerra, Hon. Xavier:
Testimony.................................................... 6
Prepared statement........................................... 55
Responses to questions from committee members................ 61
Blackburn, Hon. Marsha:
``Alone and Exploited, Migrant Children Work Brutal Jobs
Across the U.S.,'' by Hannah Dreier, The New York Times,
February 25, 2023.......................................... 165
Crapo, Hon. Mike:
Opening statement............................................ 4
Prepared statement........................................... 177
Tillis, Hon. Thom:
Submitted articles........................................... 179
Wyden, Hon. Ron:
Opening statement............................................ 1
Prepared statement........................................... 181
Communications
Center for Fiscal Equity......................................... 185
Chronic Care Policy Alliance..................................... 189
Digital Therapeutics Alliance.................................... 191
United Network for Organ Sharing (UNOS).......................... 192
(III)
THE PRESIDENT'S FISCAL YEAR 2024
HEALTH AND HUMAN SERVICES BUDGET
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WEDNESDAY, MARCH 22, 2023
U.S. Senate,
Committee on Finance,
Washington, DC.
The hearing was convened, pursuant to notice, at 10:01
a.m., in Room SD-215, Dirksen Senate Office Building, Hon. Ron
Wyden (chairman of the committee) presiding.
Present: Senators Stabenow, Menendez, Carper, Cardin,
Brown, Bennet, Casey, Warner, Whitehouse, Hassan, Cortez Masto,
Warren, Crapo, Grassley, Cornyn, Cassidy, Lankford, Daines,
Young, Barrasso, Johnson, Tillis, and Blackburn.
Also present: Democratic staff: Shawn Bishop, Chief Health
Advisor; Eva DuGoff, Senior Health Advisor; Joshua Sheinkman,
Staff Director; Tiffany Smith, Deputy Staff Director and Chief
Counsel; Kripa Sreepada, Senior Health Counsel; and Polly
Webster, Senior Health Counsel. Republican staff: Kellie
McConnell, Health Policy Director; Gregg Richard, Staff
Director; and Conor Sheehey, Senior Health Policy Advisor.
OPENING STATEMENT OF HON. RON WYDEN, A U.S. SENATOR FROM
OREGON, CHAIRMAN, COMMITTEE ON FINANCE
The Chairman. The Senate Finance Committee will come to
order.
We are meeting today to discuss with Secretary Becerra the
budget for the Department of Health and Human Services. The
President's budget comes down to a simple proposition: helping
working families and the middle class get ahead and reducing
the Federal deficit are not mutually exclusive. So today, we
are committed to doing both.
When it comes to health care, that means protecting
Medicare for the next generation by making sure that the
wealthy pay their fair share in taxes; strengthening Medicare's
negotiating power for the cost of prescription medicine; and
investing in priorities like mental health care, home-based
care, and the health-care workforce. That is a sharp contrast
to the Republican approach to the Federal budget.
Since the beginning of the year, there has basically been a
demand for secret negotiations on unspecified cuts to Federal
programs, while holding hostage the full faith and credit of
the United States Government. Budget Committee Chair Whitehouse
and I asked the nonpartisan Congressional Budget Office to run
the numbers, and it is clear that Republican promises to spare
certain parts of the budget like Social Security simply do not
add up. Sparing essential lifelines for seniors in addition to
Republican priorities means essentially zeroing out everything
else in the Federal budget.
I would like to take a moment to address press reports that
some House members are considering proposals that cut earned
benefits in Medicare or Social Security for those who are not
yet at retirement age. I want to be clear. As long as I am
chair of this committee, I will fight any effort to engage in
intergenerational warfare. There are plenty of ideas to improve
the financial health of these programs that do not include
forfeiting the earned benefits of current workers.
Now I am going to take a minute to talk about what that
means in practical terms, starting with Medicaid. Contrary to
popular belief, Medicaid acts as our country's backstop for
nursing home care, not Medicare, and since my days as director
of the Gray Panthers, I have been stunned at how many people
still believe Medicare leads in the effort to fund nursing home
care. That is just not accurate. It is Medicaid.
That means when your parents are in their 80s and 90s and
require nursing home care, Medicaid is there to help cover the
costs once they have essentially gone through all the hard-
earned retirement savings and everything they did to try to
plan for retirement while they were working. If Republicans go
after Medicaid the way they did in 2017 by cutting Federal
support to State Medicaid programs and giving States free reign
to pare back benefits, that guaranteed backstop of nursing home
care for seniors is ripped away.
That means a return to times from distant memory before the
social safety net was created, when older Americans who ran out
of savings and could not count on a family member were
essentially consigned to a poor farm. Nobody wants America to
return to that time. So let us look for ways to work together
to take on the big challenges of our time, rather than pursuing
reckless cuts that imperil the country's older people.
Now, a couple of important priorities in the President's
budget--first on prescription drugs. The President's budget has
several bold proposals to build on the Inflation Reduction Act
that hold pharma accountable for years of high prices while
lowering costs for seniors. That includes speeding up Medicare
negotiations and increasing the number of drugs subject to
negotiation. I strongly support this approach, especially as
the Centers for Medicare and Medicaid Services continue to
steadily implement the laws that are already on the books.
For example, last week the Biden administration announced
that the anti-price-gouging law that was written in this
committee, in this room on a bipartisan basis in 2019, will
lower coinsurance payment for 27 drugs in Medicare Part B. Part
B pays for prescription drugs to treat diseases like cancer and
rheumatoid arthritis administered in a physician's office. That
includes Humira and, folks, Humira is Exhibit A for why drug
pricing reforms were needed in the first place.
Important steps like these coinsurance reductions, free
vaccines, and the insulin cost cap in Medicare are just the
beginning of the big league impact this law will have on
Americans' health-care costs. I have said from the beginning
that when the Federal Government leads on flagship health
reforms in Medicare and in its key programs, we know as sure as
the night follows the day that the private sector is going to
follow, and that is exactly what is happening.
Next, mental health care--very fitting, since my seatmate
here has been the leader of that cause here in the Senate,
Senator Stabenow. Last Congress, the committee wrote black
letter law to move the country towards a reality where all
Americans can get quality mental health care when and where
they need it. I especially want to thank my partner here on the
Finance Committee, Senator Crapo. At the beginning of 2021, we
said on mental health care we were going to be ready on every
single bill, every single one, to make sure that we advance the
cause of mental health needs. And we were able to do that--on
the gun safety law; with improved mental health care in
schools; funding for community behavioral health centers led,
as I mentioned, by Senator Stabenow; coverage for therapists in
Medicare; and new GME slots for psychiatrists. Senator Crapo
and I talk often about this, and we intend to continue our
mental health work in this Congress, again in a bipartisan way.
Now one final point with respect to mental health care, to
clear up a little confusion. When it comes to mental health
parity, the Congress passed a landmark law in 2008 based on the
proposition that physical and mental health would be treated
equally. That, unfortunately, does not happen today. Fifteen
years after the law was written, the insurance companies, the
big insurance companies, are still finding ways to drag their
feet on carrying out the parity law with respect to mental
health.
So the challenge for the committee is to stop the foot-
dragging that is taking place under current law, colleagues--a
2008 law--and develop fresh approaches to give Americans what
they thought they were getting in 2008. The President's budget
takes important steps in that direction, and I am pleased that
Senator Bennet also is leading the way to put mental health
care on a better footing.
We are also pleased that the President's budget takes a big
step when it comes to postpartum coverage for new mothers in
Medicaid. At the end of last year, Congress came together on a
bipartisan basis to create an option for every State to cover
postpartum care for new mothers for 12 months. The President's
budget, to its credit, takes the next step to make that
coverage available for the country.
Finally, I want to say I think all of us had a chance over
the last few days to read a stunning report about cracks in the
health-care system for disabled folks. It was reported on in
The Washington Post. We are going to need to develop smarter
policies that provide long-term care options for families to
get the care that is best for them. One option is offered by
our colleague from Pennsylvania, Senator Casey, for home and
community-based services, and we are going to continue to
promote that.
So this is all about making some smart investments in
better health for the people of this country, consistent with
showing that you can do that while reducing the Federal budget
deficit.
After Senator Crapo has a chance to make his opening
remarks, we will introduce Senator Becerra and we will get
underway.
Senator Crapo?
[The prepared statement of Chairman Wyden appears in the
appendix.]
OPENING STATEMENT OF HON. MIKE CRAPO,
A U.S. SENATOR FROM IDAHO
Senator Crapo. Thank you very much Mr. Chairman, and I
thank you, Secretary Becerra, for being here today.
Before we begin, let me let you know. I have to at this
very time be introducing a judicial nominee for an Idaho
district judge position. So, when I finish my remarks and I
step out, I am not walking out on you. I will be back, and
before I get to my prepared remarks, I do want to respond a
little bit on the question about the debt ceiling negotiations.
I want to make it very clear. The Republicans are asking
for negotiations on the debt ceiling process, to add some
fiscal restraint into the debt ceiling extension. I ask you,
Secretary Becerra, to take back to the President my plea that
he engage with us in negotiations. I want to make it clear. We
are not talking about trying to reduce benefits in Medicare or
Social Security for our seniors. What we are talking about is
reasonable reforms that can help us get to some kind of fiscal
restraint on our spiraling debt. I would just encourage all of
my colleagues in the Senate, but particularly the President, to
engage with us in those kinds of negotiations.
I want to start my formal remarks on the positive. You have
testified before and talked to me privately about the fact that
although we have our differences on a lot of different policy
areas, we want to find those areas where we can work together,
and we found some last year. Last year, as Senator Wyden has
already indicated, we came together on a package of bipartisan
reforms to produce common-sense solutions, ranging from mental
health improvements to comprehensive telehealth coverage for
seniors and working families.
Moreover, we accomplished all of this by reducing the
deficits by billions of dollars, and the administration and
you, Secretary Becerra, worked with us on this, and we have
made good progress. I look forward to partnering with HHS, as
well as with my colleagues on both sides of the aisle, to
advance further reforms like this in this Congress, to improve
health-care access, affordability, and choice for all
Americans.
That being said, I do have concerns with the budget that
the President has put forward. Unfortunately, many of the
proposals in the President's budget run directly counter to
these types of initiatives that I have discussed. I have
serious concerns with the focus on partisan policies that risk
harming health-care access and affordability for both current
and future patients. We talked about some of this yesterday.
The budget's central proposal, for instance, would
dramatically expand the size and scope of the bureaucratic
government-run drug-pricing program enacted last year in the
IRA. Prior to that law's passage, my Republican colleagues and
I warned repeatedly that imposing sweeping price controls would
prove disastrous for patients, biomedical research and
development, and domestic manufacturing jobs, and many of our
fears have already come to pass.
We pointed to the risk of higher launch prices and
distorted pricing practices based on projections validated by
the nonpartisan Congressional Budget Office. And sure enough,
The Wall Street Journal reported in January ``the impact in
2023 may actually be higher drug prices.'' We also expressed
concerns around lifesaving R&D, as a University of Chicago
study estimated the IRA would result in 135 fewer new drug
approvals in the next 2 decades.
That figure would inevitably skyrocket under the budget's
proposed expansion. Already, numerous manufacturers have
signaled plans to table certain projects in light of the
uncertainty created by the IRA. In recent months, we have also
seen a rash of drug shortages, which even leading U.S. Food and
Drug Administration officials have attributed to pricing
dynamics. Doubling down on the IRA's price controls would
exacerbate the law's most harmful consequences.
Americans deserve better and more affordable access to
prescription drugs, and we can find bipartisan results-oriented
solutions to advance that goal. Government price mandates,
however, are a step in the wrong direction. I also have
profound concerns with the budget's bold claims of averting the
Medicare hospital insurance trust fund's looming insolvency,
largely through massive tax hikes and budget gimmicks.
This unbalanced approach does nothing to address Medicare's
cost drivers. It would also punish the small business job
creators and entrepreneurs who drive our economy.
Unfortunately, the budget takes a similarly shortsighted
approach to Medicaid, reviving a number of rejected policies
from past proposals, including hundreds of billions in new
spending tied to burdensome conditions and efforts to
circumvent State leaders.
The Federal Government should focus on supporting States as
they work to return Medicaid to post-pandemic normalcy, rather
than imposing new top-down mandates. Instead of turning to a
one-size-fits-all solution, we should look to proven models for
Federal programs, such as Medicare Advantage. With sky-high
patient satisfaction rates, Medicare Advantage shows that
consumer choice and market forces can produce more benefits and
better outcomes.
As we move forward, I encourage your Department, Mr.
Secretary, to focus on our shared goals, from cost-cutting
competition to sustainable telehealth access and other similar
issues, rather than on these partisan priorities.
I thank you again for being here today, and I thank you,
Mr. Chairman.
[The prepared statement of Senator Crapo appears in the
appendix.]
The Chairman. I thank my colleague, and my colleague and I
are not going to go back and forth about who said what, when. I
am just going to put into the record, by unanimous consent at
this point, the House Republican Study Committee proposals * to
cut Medicaid and Medicare. So specifically, that is what we are
talking about.
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* RSC Blueprint to Save America, Fiscal Year 2023 Budget, https://
hern.house.gov/uploaded
files/fy23_budget_final_copy.pdf.
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So, Secretary Becerra, we welcome you, the 25th Secretary
of the Department of Health and Human Services, the first
Latino to hold the office in the history of the United States.
You have dedicated your career to public service, most recently
serving as the Attorney General of California from 2017 to
2021. Prior to that post, you served 12 terms in the Congress
as a member of the House of Representatives.
While serving in Congress, Secretary Becerra was the first
Latino member of the Committee on Ways and Means. He served as
ranking member of the Ways and Means Subcommittee on Social
Security and ranking member of the Subcommittee on Health.
Mr. Secretary, we welcome you. I have appreciated the
chance to work with you often over the years and appreciate
your commitment to advocating for the people served by the
Department of Health and Human Services. Go ahead with your
remarks.
STATEMENT OF HON. XAVIER BECERRA, SECRETARY, DEPARTMENT OF
HEALTH AND HUMAN SERVICES, WASHINGTON, DC
Secretary Becerra. Chairman Wyden and Ranking Member Crapo,
and to all the members, thank you for the invitation.
A lot has happened in the year since I last spoke to you
about budgets. More than 16 million Americans have secured
health insurance through the Affordable Care Act marketplaces.
That is an all-time high. Altogether, more than 300 million
Americans now carry insurance to cover their health-care needs,
a historic high as well.
The President's new lower-cost prescription drug law has
capped insulin at $35 per month and made preventative vaccines
like the flu, COVID, and shingles vaccines available for free
under Medicare. Moving forward, this new law gives us the right
to finally negotiate lower prescription drug prices for
Americans. And to cap it all off, the Biden-Harris
administration has safely and effectively executed the largest
adult vaccine program in U.S. history, achieving nearly 700
million shots in arms during the COVID pandemic without charge.
The Fiscal Year 2024 budget proposes $144 billion in
discretionary funding and $1.7 trillion in mandatory funding
for HHS. It positions us to tackle the urgent challenges we
face, including a growing behavioral health crisis and future
public health threats. It also funds operations in mission-
critical infrastructure needed to build a healthier America,
moving the Nation from an illness care system to a wellness
care system.
An illness care system leaves our most vulnerable families
behind. A wellness care system invests in providing the full
spectrum of health care to all Americans. Illness care allows
the price of prescription drugs to skyrocket. Wellness care
starts by prescribing fruits, vegetables, and exercise; it
treats food as medicine. Illness care requires you to get a
referral by your family physician to see a specialist for
mental health services. Wellness care--well, it lets you get
mental health care the moment you walk through the door of your
family physician's office.
Illness care forces hardworking Americans to deplete their
life savings to get the long-term care they need. Wellness
care, it invests early in long-term care, like in-home care, so
our older American adults and our Americans with disabilities
can thrive at home and in their communities.
Our budget invests in wellness care. We invest more than
$30 billion to prepare us for the next COVID or public health
crisis, including the billion dollars to replenish our Nation's
strategic national stockpile.
On behavioral health, too many of our loved ones are dying
from suicide or overdose, so we increase access to crisis care.
We grow the behavioral health workforce, and we beef up
substance use services. We are also gearing up to handle more
than 6 million additional contacts from people who are
experiencing a mental health crisis, through 988, the 3-digit
suicide prevention lifeline we stood up last year.
This budget covers 2 million adults left out by Medicaid by
their home States and extends tax credits that make health care
more affordable for millions of Americans. It would also ensure
that expanded postpartum Medicaid coverage for a new mom and
her baby is here to stay. The President's budget not only
strengthens Medicare for today's seniors but protects and
strengthens it for the next generation.
We also take care of our family members in this budget,
investing $600 billion in child care and preschool programs,
and $150 billion to strengthen Medicaid home and community-
based services. This budget funds the Cancer Moonshot and ARPA-
H. It invests in the title X family planning program essential
to so many of our families, and it delivers on our commitments
made as part of the National Strategy for Hunger, Nutrition,
and Health. It opens more community health centers and--
important to me as a former Attorney General--it bolsters our
health-care fraud and abuse detection and enforcement work.
And the President's budget honors our responsibilities to
Indian country, with more than $2 billion in new resources in
2024. Last year for the first time, you gave the Indian Health
Service advanced appropriations, providing the same protection
against budget uncertainty that other health services receive.
We hope to build on that progress this year.
This budget reflects the President's and our values and
commitments. It helps to begin the move from a Nation focused
on illness care to one about wellness care. And importantly, it
ensures health and wellness are within the reach for all
Americans.
On behalf of the women and men of the Department of Health
and Human Services, we look forward to working with you, and I
thank you for having me today.
[The prepared statement of Secretary Becerra appears in the
appendix.]
The Chairman. Mr. Secretary, thank you. I will start it off
with respect to the trust fund. Now, the President and
Democrats are committed to protecting what we have always
called Medicare's guarantee. Medicare is not some kind of
voucher. It is a guarantee of high-quality health care, and
Americans have earned this benefit with each paycheck.
So, with this budget, the President is focused on making
sure billionaires and the very wealthy pay their fair share. It
would strengthen Medicare's negotiating authority and lower the
price of more prescription drugs and extend Medicare's solvency
for 25 years. Now what we are hearing from the other side is
giving a free pass to billionaires. All these budgets work it
out so that billionaires basically are left untouched. And now
we are seeing the full faith and credit of the United States
being threatened.
So, what I would like to do is make sure that you have a
chance to make it clear what the differences are with respect
to these issues. The President's budget, in my view, does not
cut Medicare benefits by taking steps like raising the
eligibility age, reducing access to care, or basically just
handing everything over to a bunch of big insurance companies.
Is that factually, correct?
Secretary Becerra. Senator, the President made it very
clear he will not propose any budget that cuts benefits under
Medicare for the 67 million people who today count on Medicare,
and to the millions more who are added every year. He would in
fact increase benefits at the same time that he is
strengthening the program for the future generations to come.
So, it is a proposal that was due because so many
Presidents have come before President Biden and never offered a
proposal. I, for 24 years in Congress, never saw Congress try
to tackle this in a serious way. Finally, we have a President
who says, ``Here is how we do it, and we can not only
strengthen Medicare, but we can do it without cutting one
benefit for any senior in America.''
The Chairman. All right.
Let us move on to prescription drugs and the implementation
of the Inflation Reduction Act. And I think you heard me
mention right here in this room with Senator Grassley--Senator
Stabenow was here, Senator Crapo was here. That is where we
locked in the first-ever set of financial penalties for pricing
gouging in Medicare. We saw the benefits of this this week,
with the reduction in coinsurance that is going to be of help
to millions of people. That was done in 2019 in this room, in a
bipartisan way. So we want to keep building on that.
CMS is working on a tight timeline with respect to the drug
pricing reforms, and there is a lot to do in advance of the
September 1st announcement of which 10 drugs will be the first
to go forward on the negotiation process. Last week, as I
indicated, was an important milestone with the release of the
proposed Medicare price negotiation guidance. This is in
addition to the implementation of the penalties for price
gouging, and you and I have talked about that.
It is so important that the Inflation Reduction Act
guidelines are met, and we ensure that the people who are
participating in this program are ready and that the law
delivers for seniors and the public. So my first question to
you--and you and I have talked about this--is, is it possible
for you today to commit to a timely release of the final
negotiation guidance which would come about this summer?
Secretary Becerra. Senator, that is our goal. We have never
done this before. We thank you for the resources to try to do
it right. We understand that September is a magical date when
we announce the 10 drugs that would be part of the first
negotiation. We will continue to work with you. I am committed
to make sure that each and every member in the Senate and the
House has the information they need to see where we are going,
and because you were gracious in giving us the resources to
staff up, we hope to not only meet the deadlines, but hopefully
beat them.
The Chairman. We look forward to working with you, really
month by month, to meet this September deadline. You and I have
talked about this before. This was an extraordinary victory for
the millions of seniors who would stand in those pharmacy lines
and feel like they were getting mugged by the prices. Pharma,
you know, protected this ban on negotiation like they were
protecting the holy grail. Senator Stabenow and so many others
kept making the case.
Of course you ought to negotiate. There are more than 50
million seniors on Medicare. Who in the world does not
negotiate? So last week's announcements were very good with
respect to price gouging, with respect to the list for
negotiation. We are moving ahead to make sure this gets
implemented. Tell me a little bit about what the American
people can expect to be told as this goes forward and how it
impacts them, and I will yield to my colleagues.
Secretary Becerra. Mr. Chairman, I believe we are going to
not only be transparent with you and your colleagues, but with
the American public, about how we are going about selecting
those drugs, the process in which we are going to engage the
manufacturers in this. We want them to be able to participate
as much as possible in a public setting, so people can see how
they behave in this process of negotiation and let the American
people see. Sunshine is the best disinfectant, as they say, and
we have no problem with that.
The Chairman. Very good; thank you.
Senator Stabenow will be next.
Senator Stabenow. Thank you very much, and welcome, Mr.
Secretary. There are so many different things we can talk about
that are so important and are making a difference in people's
lives. And thank you, and thank the President for doing what
you are doing.
First, I do want to recognize, I have a lot of friends in
purple shirts here from the Alzheimer's Association, and we
want to celebrate, I think over the years now, something like a
700-percent increase in research, which is so critical, and
efforts we have done to support caregivers. And the next step
is making sure that patients have the critical and urgent
treatments that they need.
And so, I will be following up with you more on that, but
this is the moment to really delve into that, and so I
appreciate that they are all here with us this week.
Let me start also by saying that Medicare and Social
Security are great American success stories that lifted a
generation of seniors and people with disabilities out of
poverty. We certainly are not going to go backwards; at least
certainly the majority in the United States Senate is not going
to go backwards.
When the chairman talks about the House Republican study
group budget, which has been lifted up as a major foundation
for what the House is talking about, it raises the age of
Medicare to 70, raises the age of Social Security to 70. I
cannot imagine doing that or privatizing the systems, turning
them over to Wall Street or private insurance companies. So I
congratulate you, and I congratulate the President for going in
a different direction, which is to strengthen Medicare and to
focus on the costs of prescription drugs and so on as we move
things in the right direction for people.
You know I have to talk about mental health. I have to talk
about Certified Community Behavioral Health Clinics. I am so
excited that this is something that we have done on a
bipartisan basis. I see Senator Cornyn here. We worked really
hard together on the Safer Communities Act, and really have the
most, the strongest investment in mental health and addiction
services literally in 50 years, and that is not an
exaggeration. So, thank you for working on that, as well as our
chairman and ranking member, who have been so pivotal in all of
it.
We have had a demonstration project with 10 States fully
funded--like health care, with clinics, quality clinics, 24-
hour emergency services. We are now working on the next piece.
You announced SAMHSA has the process for identifying the next
10 States. We want to get that all the way to 50. But I would
like you to elaborate a little more on your plans for this
really transformative system. We are moving from grants; grants
are good, but it's much better to have this be an integral part
of our health-care system with ongoing funding and support,
support for staff through work that this committee did in
expanding Medicare access for therapists, and so on. And GME
slots for psychiatrists at the end of the year--really
important work that we have done.
But could you expand a little bit on this program and the
vision around community behavioral health?
Secretary Becerra. Yes. And I have to begin, Senator, by
thanking you, Senator Cornyn, and others who really championed
this. Your fingerprints are all over this expansion of
Certified Community Behavioral Health Clinics, and thank God,
because we know that mental illness does not end at 5 o'clock.
It goes forward at midnight, 3:00 in the morning. You need to
have someone you can turn to, and that is where these Certified
Community Behavioral Health Clinics will be indispensable.
The fact is that we are going to try to give them a
permanent stream of funding so they are not open just 9:00 to
5:00, or they are not open just the first 5 months of the year
and then they run out of money. This has a consistency, and we
know that, for folks who are going through a mental health
crisis, they are looking for some stability. And so this helps
add that at all hours, all days in the year, and we are going
to build on this.
You started with a project, a pilot, and now you see what
is happening. And it is great that we are also going to be able
to help those States that start off in those projects to expand
as well, because what a shame if the States that first took the
lead and showed its success would be deprived of the chance to
expand. So, thank you very much to you and your colleagues for
what you have done.
Senator Stabenow. Well, I am really thrilled that in the
President's budget, he makes the Certified Community Behavioral
Health Clinics permanent, which is so critical. And I have to
say this was a major bipartisan accomplishment. And while he is
no longer in the Senate, my partner, Senator Roy Blunt, was
integral to this. And so, a shout-out to Senator Blunt as well.
So, thank you, Mr. Chairman.
The Chairman. I thank my colleague.
Next will be Senator Crapo. The next three--it is a very
hectic day up here, Mr. Secretary, as you know on Wednesdays.
At this point, the next three in order of appearance would be
Grassley, Menendez, and Cornyn.
So next is Senator Crapo.
Senator Crapo. Thank you very much, Mr. Chairman.
And I think I will start out with Alzheimer's. As Senator
Stabenow mentioned, we have a number of our Alzheimer's friends
here with us today. The FDA's accelerated approval pathway has
provided a lifeline for countless Americans, advancing access
to safe and effective medicines for cancers, rare diseases,
HIV, and other conditions like Alzheimer's, years before these
treatments could otherwise come to the market.
Unfortunately, this administration has taken unprecedented
steps to erode this pathway, deterring lifesaving innovation
and delaying access to care. This troubling trend began with
CMS's coverage restrictions for an entire class of Alzheimer's
therapies, and it seems set to continue with the recently
announced Accelerating Clinical Evidence Model, which would
slash payments for treatments that rely on accelerated
approval.
Secretary Becerra, I recently led a letter urging the
administration to abandon this misguided model, given the
potential for slower and slimmer pipelines of new medicines for
seniors, among other serious conditions. I also wrote to you
last year about the grave implications of the Alzheimer's
coverage decision. How does your department plan to ensure that
accelerated approval pathways remain a robust and viable option
for innovators, and most importantly for patients?
Secretary Becerra. Senator Crapo, you have touched on
something very important for me, having my father, my father-
in-law and mother-in-law with dementia in the last years, last
months of life. Very tough. We were there. My father died in my
home. We cared for him. Same with my mother-in-law and father-
in-law. My wife and her siblings cared for them. This is tough.
Dementia--it is all of us, not just the patient, and we want to
be there.
We are fortunate that in America we are coming up with new,
innovative treatments, and we are doing everything we can to
accelerate them. I give you the evidence of the COVID vaccine.
No one expected that the COVID vaccine would come out so
quickly. Whether it is Alzheimer's, COVID, hepatitis C, we are
moving and we want to be there, and we will look for every
innovative approach, every pathway possible to make sure that,
one, we can put a safe and effective drug in front of the
American people, and then also determine whether it will be
covered by Medicare.
Senator Crapo. Well, I understand that commitment. But the
accelerated model that you have adopted or are looking to adopt
and pursue is going in exactly the opposite direction. I
encourage you to revisit this model.
Let me move on to Medicare Advantage. CMS recently released
their annual advance notice, which included some significant
changes to the Medicare Advantage risk model for the upcoming
bid process. We have heard concerns from providers, patients,
and plans that these changes will disproportionately impact the
most vulnerable MA beneficiaries, including those with low
incomes or chronic conditions. Mr. Secretary, does the
administration plan to address these concerns in its final MA
rule?
Secretary Becerra. Senator, thanks for the question. Half
of all seniors who have Medicare use the Medicare managed care
model. This is critically important. We are absolutely going to
make sure that when the final gavel falls on this, it will not
only move us in the right direction with more efficiency, but
it also will protect every Medicare beneficiary, seniors, and
disabled Americans who use the Medicare program.
Senator Crapo. Well, thank you. And I encourage you to look
at this carefully, and if you have not already done it, to
conduct an impact analysis, to determine how the model you are
currently considering changes to would affect different groups
of beneficiaries. I think you will find that, once again, these
proposals are going in the wrong direction.
Let me move on to one where we can agree. That is on
telehealth. As the budget request mentions, my colleagues and I
came together late last year to advance a crucial 2-year
extension of wide-ranging telehealth flexibilities, including
for Medicare beneficiaries. Without further action, however,
these policies will expire at the end of 2024, creating a
coverage cliff for tens of millions of seniors across the
country.
Secretary Becerra, I realize this requires Congress to get
engaged and involved. But from the administration's
perspective, how should Medicare telehealth coverage look in
the longer term, and can you commit to working with Congress to
develop meaningful solutions that will protect access well
beyond the end of next year?
Secretary Becerra. Yes, Senator, this one is crucial. We
absolutely will work with you, because we do not want those
statutory flexibilities to expire. We are going to need your
help. Thank you for the leadership you have demonstrated over
the past on this one. We, for example, want to make sure that
everyone has the broadband that will make telehealth work. We
want to make sure that everyone can use a doctor wherever that
doctor is located. This requires the States to work with us to
make sure we can cross State borders.
We want to make sure that if you are in rural America or
inner-city America, you do not have to worry that you do not
have a way to get to the doctor. You will have access through
telehealth.
Senator Crapo. Well, thank you. And encourage us as
strongly as you can to get that legislatively done. I know
Senator Wyden and I are working very closely together on this,
and I just want some strong support from the administration.
The Chairman. Thank you, Senator Crapo. And you are right:
we are working together on a number of these issues. I just
want very quickly, before we go to Senator Grassley, to say we
very much appreciate having Alzheimer's advocates in the house
today.
My mother was at Channing House in Palo Alto for years and
years on end with Alzheimer's, and they were one of the
country's--and continue to be one of the country's leading
institutions in terms of dementia care and Alzheimer's. So you
are hearing from all of us up here that we are committed to
working with you.
The other point I wanted to mention involves the medicines,
the drugs. That is, I am a very strong supporter of accelerated
approval for these very exciting new drugs for Alzheimer's. My
colleague and seat mate, Senator Stabenow--I am still trying to
persuade her to not retire--is leading the cause in terms of
these new medicines.
It is just very important to remember what was agreed to
originally, and that was, when you have accelerated approval so
we can make sure we are keeping our commitments to these
patients, it would be followed up by the drug companies
presenting evidence of the progress with respect to how the
drugs are working on patients and working with patients.
That was part of the accelerated pathway in 1992. So I want
all the folks who are doing this wonderful work advocating for
patients to know, we are going to support you. We are going to
look for research, we are going to look for new medicines. The
accelerated approval is part of it, and the pharmaceutical
companies have agreed, after the drug is approved, to continue
to furnish evidence of its progress. That is very important.
Mr. Secretary, you remember that was what Dr. Califf agreed to
with me when we were considering his nomination.
Senator Grassley?
Senator Grassley. Thank you very much and--two thank yous.
First of all, you very quickly instituted the over-the-counter
hearing aid, the hearing aid law that Senator Warren and I
sponsored. I also want to thank you for enabling the transition
health plans to continue, because 65,000 Iowans are benefiting
from that action, and many of these people are farmers and
small business owners. Letting them continue has been a
bipartisan priority under Presidents Obama, Trump, and now
Biden. So I hope HHS allows them to continue in the future
beyond 2024.
Now let me go to my first question. Members of this
committee, including this Senator, are investigating the deadly
failures of our Nation's organ donation system, the Organ
Procurement and Transplantation Network. I have been looking
into this network a long, long period of time. The problems
have gotten worse. Thousands of patients are dying every year,
and billions of taxpayer dollars are wasted because of gross
mismanagement. The system is rife with fraud, waste and abuse,
corruption, and even criminality. This committee has received
credible allegations regarding the United Network for Organ
Sharing, relating to that organization threatening
whistleblowers, including even patients and caregivers.
Simply put, this is beyond unacceptable. These efforts
appear to be part of an attempt to cover up failures and
prevent competition for its government contract. So, a question
to you: I hope that you can commit to fully investigating all
instances of whistleblower retaliation and harassment. Would
the HHS commit to removing anyone involved in that improper
conduct from any involvement in the Organ Procurement and
Transplantation Network leadership and committees? If you do
not agree with me, why not?
Secretary Becerra. Senator Grassley, first, thank you for
the work that you have done. As you mentioned, this has taken a
long time, and thank God that you have committed to it. On the
whistleblower question, we are absolutely committed to working
with you to make sure that if there is a claim made about a
particular operation, we dive right into it to find out what is
going on.
Let me give you the more important news. Today we are
announcing at HHS that we are going to put forward a
modernization initiative, which will do a number of things that
I think you are going to like. One, we are going to call for
competition in who becomes the contractor for these organ
procurements and the transplant services, and so it will no
longer be just one company the way it has been for what, 40
years? So that is one big change that will occur.
Secondly, we are going to require transparency. They have
got to start sharing their data. They cannot hide, as you just
said, behind this confidentiality and say, ``We cannot show you
what is going on because it is confidential.'' We are going to
require far more data transparency. Again, this follows all the
work that you have done.
Then finally, we are going to try to upgrade the IT system
which, as you can imagine with these contractors never having
changed--everything gets stale; so does the IT.
We are going to try to update the IT so we can be efficient
with those organs that we receive, so we can get them to
someone, instead of have them ultimately be discarded because
they did not get used in time. Those are things we are
announcing today, and in the President's budget, he calls for
resources so we can implement this. So we are absolutely going
to call on you for your help to try to move this forward, get
your input. But again, much of what we are announcing today is
a result of the work that you have done over the years.
Senator Grassley. Thank you for your initiative.
I want to turn to rural health care. I want to thank the
administration for implementing the new and voluntary Rural
Emergency Hospital program that I have worked for 3 or 4 years
to get passed. Another rural hospital program that you may not
know so much about is called the Rural Community Hospital
Demonstration. It extends the financial viability of 26 small
rural hospitals in 11 different States, five in Iowa.
The program has taken up to 30 hospitals. But CMS is
currently underutilizing the program. Congress has authorized
the program for several more years. While there is interest in
rural hospital participation, CMS has told me that they have no
interest in filling the four additional slots. I realize that
you may not know much about this program. Do you think that we
should be underutilizing cost-effective rural hospital programs
like the Rural Community Hospital Demonstration?
Secretary Becerra. Senator, I am familiar with the program,
and we are making a concerted effort in rural America to inject
some life into some of these facilities, because as you know
very well, too many of them are closing, and they are not being
replaced. When they are being replaced, they are first being
gutted of some of the essential services that they used to
provide. So we have dedicated services into rural community
hospitals.
But we are going to try to do more, and we certainly will
take your lead on some of these initiatives, because we know
that those of you who go back home every day and have to deal
with those providers know exactly what they need and where they
need to go. So we will look forward to working with you.
Senator Grassley. Thank you, Mr. Secretary, and thank you,
Mr. Chairman.
The Chairman. While he is in the room, let me thank Senator
Grassley for working in such a bipartisan way over the years to
improve the system with respect to organs and organ
procurement. Yesterday, there was, in my view, a big victory
for families across the country who have been fighting for more
effective organ procurement and transportation system. The
administration indicated they would work with us to have more
competition in this UNOS contract.
This committee has felt, on a bipartisan basis, that there
has not been enough competition for the contract and meeting
the expectations of Americans waiting for transplants. So I
want to thank my colleagues on both sides of the aisle. Senator
Grassley in particular has been at this for years, and I look
forward to working closely with him.
Senator Menendez is next.
Senator Menendez. Thank you, Mr. Chairman. Mr. Chairman,
before I go to my questions, I just simply want to say, I want
to echo your comments as someone whose mother had a 10-year-
long goodbye with Alzheimer's. We have a moral, as well as an
economic imperative to end Alzheimer's in our time, and so I
hope the budget will reflect that as well.
Mr. Secretary, for years communities across the country
have struggled to fill major provider workforce gaps, a growing
crisis exacerbated by the pandemic. I have long championed
legislation to address the physician shortage by increasing the
number of
Medicare-funded graduate medical education slots, and based on
my legislation, the Resident Physician Shortage Reduction Act,
Congress authorized the creation of 1,000 new Medicare-funded
GME slots in the Consolidated Appropriations Act of 2021.
It outlines specific eligibility criteria for distributing
these slots. However, the kingdom of CMS, in its final rule for
2022 and again in 2023, included additional criteria not
specified in the law. This additional location-specific
prioritization unfairly disadvantages States that have few
geographic or population HPSAs. As a result, in New Jersey and
other States, we are completely, completely shut out from
obtaining these critical residency positions.
The CAA of 2021 clearly specifies that ``the Secretary
shall,'' not may, ``shall distribute up to 200 residency
positions each year and shall distribute not less than 10
percent of the residency positions to each of four specified
categories of providers.'' That is the law. That is what
Congress's intent was. Now, I raised this with CMS last year.
They failed to address this issue.
Can I have your commitment to work with me to revise the
methodology used to distribute future residency positions so
that we follow Congress's intent and the law, and that States
are not totally shut out of this program?
Secretary Becerra. Senator, first, thank you very much for
the work you have done on graduate medical education, and
absolutely, you have my commitment to work with you on this.
Senator Menendez. Thank you. Now, I am concerned that the
proposed advance notice Medicare Advantage rate announcement
will create further health disparities for the 640,000 Medicare
Advantage beneficiaries in Puerto Rico. As you know, Puerto
Rico seniors overwhelmingly depend on the MA program, with an
MA penetration rate of 94 percent among beneficiaries eligible
for Medicare Parts A and B.
The proposed changes could impose the largest year-to-year
reduction in Federal health funding to Puerto Rico, a change
that is harmful not only to the most vulnerable beneficiaries,
but to the island's health-care system and economy, one that we
have been working towards improving. This is going to set them
back. Further, the MA program in Puerto Rico supports health
access and equity by filling gaps in care resulting from the
island's exclusion from many of the Federal health benefits.
I am concerned these changes could undermine progress we
have made to date to address disparities on the island,
including recent funding gains achieved for the Medicaid
program, which I fought for. What is the administration's plan
to ensure any proposed changes are not magnifying disparities
and reducing services provided to beneficiaries on the island
who are United States citizens?
Secretary Becerra. Senator, thank you for the question, and
as we mentioned earlier, when 67 million people count on
Medicare, about half of them count on it within the managed
care program of Medicare. We have to make sure we get it right.
We are in the process of reviewing all the comments that we
received based on that advance notice, and what the President
said is, we will guarantee that there will be no cuts to the
benefits under Medicare in this proposal, that the providers
will see in most cases an increase--a substantial increase in
some cases--to the reimbursement monies they are receiving----
Senator Menendez. Yes, and this is--with all due respect,
this is in the broader context. But you've got to look at
Puerto Rico specifically in the disproportionate way it gets
affected. So I am worried that while we are talking broadly,
the effect in Puerto Rico for the 3.5 million United States
citizens is disproportionate. So I am going to follow up with a
letter regarding Medicare Advantage in Puerto Rico, urging you
to address anomalies in the rate formula to mitigate funding
disparities for the island.
Secretary Becerra. I look forward to that.
Senator Menendez. Finally, last month The New York Times
published a disturbing report on the illegal use of migrant
child labor by several major companies. Some as young as 13-
year-olds are unaccompanied minors who came to the United
States and were placed with sponsors by the Office of Refugee
Resettlement. They are often made to work long hours in
hazardous conditions. What are we doing to make sure that that
does not happen again?
Secretary Becerra. And, Senator, like you, I have three
daughters. Children are children. We should treat every child
in America the way we would expect to have our children
treated. It is a serious issue when someone claims that a child
is being forced to work, especially in dangerous conditions. We
take very seriously our role at HHS to make sure that while we
have custody of a child--and remember, we receive custody of
these unaccompanied migrant kids from the Department of
Homeland Security.
When we do, we are obligated to provide them with the care
that you would expect for a child, while we are in the process
of trying to find them a suitable setting to live in, because a
large congregant care setting is not the most ideal for any
child. And so we go through the process of trying to look for a
sponsor. We go through a vetting process where we vet all
potential sponsors. And by the way, almost all--about 90
percent of those sponsors--end up being a family member, an
immediate family member.
And so what we try to do is make sure that when we do
finally place that child in the hands of a sponsor, that they
will receive the care that they are supposed to. What we are
finding is that, oftentimes, a lot of these children are now
being employed, and I hope that we go aggressively--you, we--
all go aggressively at any employer that would think that it is
right to allow a 12- or 13-year-old to work in conditions that
are not even safe for adults.
That is where we have to go and make sure that we are not
failing children, and that is why we announced that in a joint
effort, the Department of Labor and the Department of Health
and Human Services will work to try to make sure that we can do
what we can within our jurisdiction to avoid that happening. At
HHS, that means trying to get sight from DOL if they know of a
particular individual who is seeking to be a sponsor, who may
be engaged in the practice of using or employing, or allowing
kids to be employed, in ways that are detrimental to them.
We are going to try to do the best we can to make sure we
have that fight early, so that no sponsor like that would ever
pass our vetting process.
Senator Menendez. Thank you, Mr. Chairman.
The Chairman. I thank my colleague, and I want my colleague
to know I appreciate his leadership, and I especially want to
help with that last point that you made. This is outrageous,
that companies are exploiting 12-year-olds. In order to make a
quick buck, they are taking advantage of these kids. It is
outrageous, and I look forward to working with you and
following your lead.
Senator Cornyn?
Senator Cornyn. Thank you.
Mr. Secretary, last year, approximately 108,000 Americans
died of drug overdoses, including 71,000 roughly from synthetic
opioids like fentanyl. Do you believe we have a public health
crisis when it comes to these overdose deaths?
Secretary Becerra. Absolutely; absolutely.
Senator Cornyn. And one reason why we have this public
health crisis--which you and I both recognize as such--is
because we have lost control of our southern border. We have
seen millions of people show up, some claiming asylum, some
being placed--like unaccompanied children--through your offices
with sponsors in the interior. And of course the asylum system
now essentially is a free pass into the interior of the United
States, and due to the backlog in the immigration court system,
many of these cases will never be reached, assuming people
actually show up for their immigration court hearing in the
future, with very little consequences for failing to do so.
As you know, title 42, which is the public health title
that was implemented because of COVID, will expire in May. I
would like for you to tell us what the administration's plan is
to deal with this public health crisis and this humanitarian
crisis caused by the lack of any controls at our border?
Secretary Becerra. And, Senator, I will try to concentrate
my comments on the work that we are doing at HHS, and I will
let my colleagues speak to the work that they are doing, for
example, at the Department of Homeland Security and others, on
other aspects of this.
Senator Cornyn. Well, I would like to know what the plan
is. I assume you have been consulted and collaborate on that
plan. But so far, we have not seen anything that is credible in
terms of dealing with this, and as bad as it is now, which has
never been worse when it comes to the flow of drugs and people
across our border, it will get worse if title 42 expires and
there is not an adequate plan put in its place to deal with
both the flow of drugs and people.
Secretary Becerra. Yes, and to your point, because we are
having to work under a very broken immigration system, as you
mentioned, these are the things that happen. I know that, for
example, the Department of Homeland Security has tried to move
the asylum process in a way that lets us get to these cases
quicker and adjudicate them, so that way we can move through
that process.
But in terms of HHS, we continue to try to be prepared,
because we do not know who will cross that border as a child
who is unaccompanied and when we will have to be ready to
secure them from DHS within 72 hours, so they can be in an
appropriate setting. So what we are doing is preparing for
whatever the eventual outcome is, to make sure that we respect
the rights of any child to receive care that is essential, and
we are going to continue to do that at HHS.
Senator Cornyn. Well, Mr. Secretary, I will just give you
one person's opinion. I think the Biden administration has
completely dropped the ball when it comes to the border, and
unfortunately, we have seen all of these deaths. I went
recently to a high school right outside of Austin, where I
live, and talked to the parents who have lost young people who
thought they were taking something relatively innocuous, but it
was laced with fentanyl. And as you know, the cartels use
industrial-type pill presses to make what looks like a normal
pharmaceutical product, but in fact it is tainted with
fentanyl, which, as you know, is extraordinarily powerful, and
small amounts will kill.
I want to just say the one thing I would congratulate the
Biden administration on is their commitment to implement the
bipartisan Safer Communities Act. Senator Stabenow acknowledged
one of the most important parts of that bill that Senator
Tillis and Senator Sinema and Senator Murphy and I were
involved in, and actually all of our colleagues were involved
in, in one way or the other.
But we made the single largest investment in community-
based mental health care in American history, and I think that
is something we are all going to be very proud of and will
address a huge unmet need.
But the last thing I want to say in the few seconds I have
is just to ask for your help. Senator Menendez talked about the
workforce shortages. Nowhere is that more apparent than in the
mental health and physical health delivery systems.
We tend to focus, like through a soda straw, on
reimbursement rates, because the Federal Government is trying
to figure out how can we cut health-care costs, make it more
affordable. But we have a confluence of problems when it comes
to recruiting and retaining health-care professionals. We have
erosion of the standards for providing those professional
services through scope-of-practice issues.
I would like to ask if you will be willing to work with
us--particularly the chairman, the ranking member, who
obviously will set the agenda--in working on all of these
issues as part of the same problem, as opposed to dealing just
with the reimbursement issues in isolation.
Secretary Becerra. Senator, we will look forward to hearing
from your staff so we can follow up with you. This is
absolutely something the President has asked us to follow up
and work on. The President does dedicate monies to workforce
expansion and development and also resilience. So we will look
forward to working with you on this.
Senator Cornyn. Thank you.
The Chairman. Senator Cornyn, thank you again for your
leadership, your ongoing leadership on these mental health
issues, and I think there are some more opportunities,
particularly for public-private partnerships. In our part of
the world Connie and Steve Ballmer have funded behavioral
health studies at the University of Oregon. I think it is going
to be a model for the country to get more workers.
Senator Cornyn. Mr. Chairman, as you know, it was the
product mainly of this committee, the Finance Committee, that
made that possible as part of the bipartisan Safer Communities
Act. So, thank you for your leadership, as well as that of
Senator Crapo. I think that is a big deal.
The Chairman. To be continued. You are absolutely right.
Next will be Senator Cardin.
Senator Cardin. Thank you, Mr. Chairman. Secretary Becerra,
welcome. It is good to see you.
I want to underscore the point of Senator Grassley in
regards to the organ transplant issues. The reform of the OPTN
process will save lives. We lose 17 Americans every day
awaiting an organ transplant. So this is an urgent issue, and I
just thank you for your response and the actions that you are
taking.
I want to turn to the issue of drug shortages. We are the
wealthiest Nation in the world that spends the most of any
nation on drugs, and yet we have important drugs that are in
short supply here. According to the American Society of Health-
System Pharmacists, 160 drugs were added in 2022 to the drug
shortage list. Forty-eight percent were in sterile injections,
making a total of 295 active drug shortages here in the United
States. These are drugs that are critically important to your
health care. Some are in cancer treatments and other areas. So
the President's budget deals with extending expiration dates,
which I think is important.
Senator Collins and I have introduced legislation on that
to deal with disclosure. How do you intend to mitigate this
challenge that we have in this country?
Secretary Becerra. You know, Senator, I am glad you raised
this because, whether it was the issue of infant formula or
whether it was the winter flu, we are seeing that in so many
cases, the industries that we count on to provide us effective
medications are not ready for disruptions, for a broadside.
That is because we have gotten into a system where these
industries, to save money--and they are entitled to try to save
money--have gone towards a supply chain methodology that
essentially says we are going to keep in inventory only the
stock that we need immediately.
If all of a sudden you have a major increase in demand, you
cannot meet it. Or if something happens with a manufacturer
that has to go down because there is an issue of safety or
cleanliness, then all of a sudden the supply goes down, and
they are not ready to meet the need. So what we have done is,
we have begun to do more surveillance over how these private-
sector industries are handling their supply.
We do not regulate that supply, but we want to have more
eyes on it so we can make sure they are preparing for that
broadside that might come. We are also trying to make sure we
help to mitigate any supply chain interruption. So, if they get
some of their material for their product from overseas, some
country, we want to make sure there is not going to be a
disruption--whether politically based or supply-based--that
keeps them from being able to produce. So we will work with
you, because this is a big issue.
Senator Cardin. Well, as we saw for the pharmaceutical
industry, how they manipulated the market for profits for
insulin, the same thing is happening on less-expensive drugs,
where they are changing their production capacities in order to
maximize their profits, which we understand. But since we are
the largest payer for these services, it seems to me we can
have a stronger impact on their decision-making.
Secretary Becerra. We will look forward to working with you
on that.
Senator Cardin. As you know, oral health is closely tied to
physical health. The final Calendar Year 2023 Medicare
physician fee schedule rule expanded dental services tied to
medically necessary conditions, which means that these services
will now be covered for Medicare beneficiaries. That is a step
in the right direction.
But as you and I know, we have major gaps in both the
Medicaid and Medicare programs in regards to coverage for oral
health and dental services, particularly in the underserved
communities. They are particularly vulnerable. So what steps do
you intend to take in order to deal with access to oral health
care in America, particularly in underserved communities?
Secretary Becerra. Well, as you said, one of the first
steps we took is to try to make sure that where we had the
authority, we expanded access to dental care services to folks
on Medicaid. And we have made the effort--with your support--to
try to expand coverage within Medicaid for dental health
services more directly.
We count, in many respects, on our community health
centers, which are able to use some of the funding they get to
expand services, including in dental health. We are going to
try to do everything we can within the authorities we have to
expand access, because we know an infection that is related to
your dental situation could ultimately impact your overall
health.
You know the story of Deamonte Driver, a young man from
your State of Maryland, who died because, at the end, a
toothache which his parents did not have the money to have him
go see a dentist for, became an abscess and it became an
infection, and before you knew it, Deamonte was dead.
Senator Cardin. It is one of the best investments we can
make--oral health. We get great returns.
Let me just say in concluding that, in hepatitis C, I thank
you for your efforts there. We need to identify those who have
hepatitis C. The treatments are there. It saves lives, and it
saves cost. So I appreciate the initiative in your budget, and
I would hope Congress would work on budget rules which would
encourage that type of service to deal with diseases.
Secretary Becerra. We are backing up your hope.
The Chairman. Senator Bennet is next.
Senator Bennet. Thank you, Mr. Chair.
Mr. Secretary, thank you for coming back, and thank you for
your service.
As you know, Congress acted in a bipartisan way to address
surprise medical bills through the No Surprises Act in 2020. I
worked with Senators Cassidy and Hassan on that legislation. We
built a big, broad bipartisan coalition, and we hoped to ensure
a level playing field between providers and insurers as they
resolve payment disputes.
Through the dispute process that we set up, both parties
were supposed to be able to provide information specified in
statute--specified in statute--and the arbitration entities
were required to take this information and weigh it equally.
But we have heard a lot about how the implementation has been
challenged, and to be completely plain and simple about it, Mr.
Secretary, we believe the administration is not implementing
the legislation as intended. We are seeing lawsuit after
lawsuit from providers. Insurants are not responding in a
timely manner, sometimes not at all.
And even when the payment determinations are won by
providers, payers still do not pay providers after the
statutory deadline. It is a big mess, and CMS has frozen and
unfrozen the process over the last few months, which has led to
a significant reduction in cash flows, leaving providers on the
hook for tens of thousands of disputes. While patients are
still technically protected, these implementation challenges
harm every single patient because they do not know whether
providers are actually going to be there to provide the
services that they need.
So, we've got to get this back on track, and I just want
you to know that I am willing to work with you and others to
get this in the right place. In the budget, HHS requested
another $500 million to implement this bill, but I do not see
evidence that it has gone well or right by congressional
intent. Can you give me your assessment of what has gone wrong
and how you intend to reduce the backlog and legally implement
this bill?
Secretary Becerra. First, thank you, Senator, for your work
in helping us have this critical law passed. But secondly, I do
not think you or I knew what was going to come. So let me ask
for your help. I am going to plead for your help. We are
receiving more than ten times the number of claims that anyone
ever expected, and these arbitrators that are supposed to go
through these claims are swamped.
Remember, they do not get paid unless they adjudicate the
claims. What we are finding is that way too many--I don't want
to say the vast majority--but way, way too many are frivolous,
because there is no cost to file a claim. So, everyone is just
filing all sorts of claims, and these arbitrators are trying to
figure out what cases to handle. That is what is bogging down
the system. But I will tell you this: we are staying true to
the law. We are not letting patients get caught in this food
fight between the provider of the care and the insurance
company that has to pay for the care.
We are making sure patients are not getting the bills in
the mail saying ``you owe this money.'' It is going to be
between the provider and the insurer, and what we are trying to
do is have a system that works. So I plead with you and your
colleagues: help us make sure that we get to the legitimate
cases, so a provider who is looking for a real payment or an
insurer who is saying, ``Hey, you are asking for too much,'' we
could adjudicate that----
Senator Bennet. Okay. Well, let's--I have another question
I want to ask, but I think we have--I do not know whose fault
it is, but we have a system that does not work, I think. So I
certainly will help, and I volunteer Senator Hassan and Senator
Cassidy too, to figure out how we can all work together to do
it. [Laughter.]
Secretary Becerra. I am writing names down.
Senator Bennet. Well, you should only write my name down
three times, but I will try to get the other folks. And I want
to say again, thanks for your leadership. Just a few months
ago, as the chairman knows, the CDC put out their latest youth
mental health report. It confirmed what I have heard across
Colorado over just the past few years: we have a youth mental
health epidemic in America, a mental health crisis in America.
According to the CDC report, 40 percent of high school
students felt so sad or hopeless last year that they could not
engage in their regular activities for at least 2 weeks. I was
saying to my staff the other day that, when I get a call from
Colorado that somebody the age of my daughter has died, I no
longer ask if it was a car accident or was it leukemia. The
question is, was it suicide, or was it fentanyl, or was it a
gun?
By the way, when I was the Superintendent of the Denver
Public Schools, we never asked that question just 15 years ago.
It is also true for seniors, you know. One in five Medicare
beneficiaries have mental health conditions and, among Latino
seniors, that goes up to nearly one in three. I know we have
done a lot in this committee on mental health, but we have to
do more, and I am glad the HHS budget calls for parity in
Medicare Advantage and invests in integrated mental health in
the primary care.
This is why I introduced with Senator Wyden, Chairman
Wyden, the Better Mental Health Care for Americans Act. Our
bill would require parity for Medicare Advantage plans, Part D,
and Medicaid, and increase reimbursement across programs for
integrated care. I am extremely grateful--I am coming to the
end of my questioning; I know I am out of time. I am extremely
grateful to your staff for working with us to draft that bill,
and I just want to ask you if, as we continue to work on it,
whether you would be willing to work with us on it, because I
am sure you're detecting the same trends in mental health that
we are. Maybe with just 5 seconds you could----
Secretary Becerra. One second: yes.
Senator Bennet. Thank you.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Bennet, and thank you for
your leadership on this. It takes your breath away what some of
these gaps are. You know, we know in Eugene, OR, for example,
if a young person has a problem in school, in effect has a
major breakdown, there is literally no treatment bed for them
at that time. So you are doing incredibly important work.
Senator Bennet. Thank you.
The Chairman. Senator Lankford is next.
Senator Lankford. Mr. Chairman, thank you. Mr. Secretary,
good to see you again.
I had a parent who was in my office today. As you can
imagine, the parents who come here to DC do a lot of research
and a lot of background, and when they bring questions, they
bring very different types of questions. Their particular child
had a health-care issue, and they were asking about the cost of
drugs. They went through several different proposals that are
out there, but then they asked a very specific, pointed, well-
educated question about pharmacy benefit managers.
They asked what is being done, because that seems to be a
black hole, and all I am reading and seeing seems to be a lot
of information on that. Now that's interesting. I said they
were very perceptive to be able to go through the different
aspects on that. You talk a lot about drug policy, but there is
nothing about PBMs in some of the proposals in your budget
piece.
Now CMS--we work with them directly on it. I want to talk
to you about some of that as well. But for the PBMs in
particular, they are not even mentioned once. What is the plan
at this point on dealing with drug pricing and the PBMs?
Secretary Becerra. And, Senator, thank you. And they may
not be as directly included within the budget, but the
administration is working on PBMs, because we know more and
more, there is a growing concern that the middlemen in the
process of getting drugs from manufacturer to patient are
skimming off a good deal of the money that is being generated.
What we want is for consumers to get the drug at the lowest
price possible.
I will tell you that most of these issues will likely end
up in court, as you can expect, but we are going to try to move
to make sure that if there is a middleman that is going through
the process of making sure a drug is getting from the
manufacturer to the patient, that it is done efficiently. So we
could use your help to make sure----
Senator Lankford. Well, we would be glad to work with the
administration. You will find bipartisan support to be able to
deal with this. Some basic elements of transparency--obviously,
PBMs are very opaque about where the pricing is, where the
money actually goes, or even the standards for evaluation.
Different pharmacies are evaluated different ways, different
months even, where they don't even know the evaluation of the
price on it. So getting some standardization--we have made
those recommendations to your team. We would love to be able to
work on that, and if we need legislation, be able to fix it.
Let us continue to work on that.
If I can continue on that same theme, this issue of tiering
is becoming more and more important--where the drug will be
released out. There can be a generic drug that is released out
later in competition, but according to the PBMs and the
original manufacturer, it is put on a branded tier, meaning
that the patient at the pharmacy counter is paying the more
expensive rate, rather than the generic rate for their
pharmaceutical, and it also becomes an issue for Medicare as
well.
That is not an issue that you brought up on this, but it is
a really big issue that we need to be able to address: this
whole issue of tiering, of where a new generic drug comes out,
whether it is on a branded tier or generic tier. Can you help
us try to settle this issue to lower prices?
Secretary Becerra. We will follow up with you, Senator.
Senator Lankford. Thank you for that.
Let me talk a little bit about something Senator Menendez
brought up as well, and it is this issue of the children in ORR
custody who have come across the border. These are the
unaccompanied minors. The New York Times published this report
that was pretty horrific about labor, but this is not new. It
is something Senator Portman and I and several others have
worked on for several years, trying to be able to figure out
how we can actually manage this.
The Times actually identified that there is a stat that
there are 85,000 children that HHS lost immediate contact with
once they were placed in sponsorship. So that is my first
question: is that number accurate, because once HHS does the
vetting, places them with sponsors, the next question is, do
you know where they are, even for those first 30 days? And then
when you get to Day 31, do you know where they are?
And if I can push this a little farther, if they do not
show up for their first hearing, is someone from HHS checking
on them, because at that point they are lost.
Secretary Becerra. And, Senator, every week I get briefed
by my team, sometimes two or three times a week, on this
situation with the unaccompanied migrant kids and where we
stand. I have never heard that number of 85,000. I do not know
where it comes from, so I cannot attest. I would say, it does
not sound at all to be realistic, and what we do is, we try to
follow up as best we can with these kids. Congress has given us
certain authorities. Our authorities essentially end the moment
we have found a suitable sponsor to place that child with.
We try to do some follow-up, but neither the child nor the
sponsors are actually obligated to follow up with us. We make
every effort to follow up with them as best we can.
Senator Lankford. But that is the first 30 days; there is
the
follow-up that is actually happening there. But if they do not
show up for the first hearing, there is no follow-up at that
point; is that correct?
Secretary Becerra. The follow-up for purposes of the
immigration proceeding would be, I believe, through the
Department of Homeland Security.
Senator Lankford. Okay. Well, at this point, no one's
following up. There are some assumptions that are made there
that if an unaccompanied minor has been placed in the home and
then they do not show up for hearings, no one seems to be
checking on them to be able to figure out are they still at the
same address they were dropped off at, what are they doing, and
why are they not showing up at hearings?
I also understand that you have called for an audit, a 4-
week audit in February, on that. My understanding is, that
audit concludes next week. Is that something that we could get
a copy of--that audit report as well--to be able to see next
week when it is finished?
Secretary Becerra. Let me make sure, Senator, when we have
that audit finished, if we are able to share publicly the
results of that. I believe we can probably share most of the
information, because most of the process that we use is public.
Senator Lankford. Right.
Secretary Becerra. And what we are trying to do is make
sure that our checks on vetting are catching anyone who should
not be considered a suitable sponsor. And so our audit is for
the purpose of making sure that our background checks are
fulfilling that mission.
Senator Lankford. Right. I do not know why there would be a
good reason you could not share with this committee. And even
if we were seeing it just locked in with this committee to be
able to see it and it was not publicly released, I do not know
of a reason that audit could not be released.
Secretary Becerra. There are issues of privacy for the
children and so forth, but we will----
Senator Lankford. I get that, but there are probably not
kids' names in the report; but thank you.
The Chairman. Senator Lankford, thank you for bringing up
the pharmacy benefit managers, what we all know as PBMs. We are
going to be having a hearing next Thursday in this committee
specifically on them. It is a result of Senator Crapo and I
having had a number of conversations about it, and I want to
let my colleagues have a chance to ask their questions. But
this conversation will continue, and I hope, colleagues, every
member can come next Thursday.
Senator Cassidy?
Senator Cassidy. Thank you. Mr. Secretary, thank you, sir.
We had kind of let you--thank you for, you know, the
dialogue before the meeting. We told you we were concerned
about, how do we know the people at HHS are working? So let me
put this picture up. This is a picture taken at 10:40 a.m. last
Monday at HHS headquarters. It's like empty, and then we could
have pictures of other parking lots that are similarly empty.
So you know, wow! The building's empty. If there's no cars,
the building's empty. So we just appropriated $3 billion--well,
first, tell me this, please. Can you give a breakdown of how
many full-time employees are at their desk in one of these
buildings every day?
Secretary Becerra. Senator, when you take a look at the
workforce at HHS, we are close to 90,000 throughout the
country, and working in various parts of the country, some here
at headquarters. By the way, at headquarters, we have an
underground parking lot----
Senator Cassidy. I have limited time, so this may be
misleading. So tell me what percent of the employees are at
their desk, full-time employees are at their desk on any given
day. And I do not mean to be rude. There is just such limited
time.
Secretary Becerra. No, and I appreciate that. Our folks are
working full-time.
Senator Cassidy. No, but how many are at their desk as
opposed to being at home or someplace else, the coffee shop or
whatever?
Secretary Becerra. What we make sure we care about is that
they are performing, and they are delivering, and that is why--
--
Senator Cassidy. Well, that is not really answering my
question, because I know the best practice now in many
industries is to bring people back in. So, is it 5 percent, is
it 10 percent, is it 1 percent? How many folks are actually
sitting at their desk in a government building when they are
working full-time every day?
Secretary Becerra. And we have folks who, as they are
working full time----
Senator Cassidy. So that is kind of not an answer. Clearly,
sir, you do not want to answer that question, and I do not mean
to be rude, but you do not. But that kind of begs that the
answer may not be flattering.
When CMS put out a request for employees, as regards to the
complex drug negotiation that was in a recent bill, the posting
offered ``generous telework policy.'' What does ``generous
telework policy'' mean? If somebody hired into that program,
how many days a month would they be expected to actually be in
a government building, as opposed to wherever they wish to be?
Secretary Becerra. And, Senator, that would depend on the
worker. Some people have never left their job even during the
height of the pandemic.
Senator Cassidy. I am not speaking about leaving their job.
I am speaking about being at their desk. I am not speaking of
some, but of a percent, if I may, because anecdotes are not
data.
Secretary Becerra. You are limiting the scope of what we
do. We have investigators who never sit at desks.
Senator Cassidy. No, but say, take somebody who
traditionally would have been at their desk before the
pandemic, please.
Secretary Becerra. And depending on the work that has to be
performed, they will be in the office at times; sometimes they
may be in the field. But what is important----
Senator Cassidy. Can I ask just for the record--because,
obviously, it does not seem, Mr. Secretary, you are prepared to
answer that question--but for the record, can you give us a
percent of the actual workers who are full-time who would be
expected to be at their desk, not an inspector in Louisiana,
but someone else? If you can give us that for the record.
Secretary Becerra. We can follow up, Senator.
Senator Cassidy. Can the agency provide us VPN data, or
some other measure of accountability, that shows that the
people truly are working from home?
Secretary Becerra. We can certainly show you that they are
performing. The fact that 700 million shots have gone into the
arms of Americans----
Senator Cassidy. But do you have that VPN data, because
initially when the pandemic started, we saw VPN data that
showed a double-digit number of employees were not turning on
their VPN every day, and so it suggested they were not
accessing emails, for example. So is that data still being
collected? If so, can you share those results?
Secretary Becerra. I could try to get back to you on that.
Senator Cassidy. Now, if you live in the DC area, you get a
work differential. So you get a little bit more. Your cost of
living is more. So if someone who is in this building with an
empty parking lot, if someone in that building, not knowing
where they are currently working, are they still getting a
cost-of-living adjustment as if they are working in Washington,
DC?
Secretary Becerra. Yes. First, I have to tell you, Senator,
that is not the headquarters of the HHS, of the Department of
HHS.
Senator Cassidy. It is CMS headquarters.
Secretary Becerra. Oh, okay, okay. So we can get back to
you on it. If someone is working--as I said, we have been
coming in day-in/day-out. We have been performing day-in/day-
out.
Senator Cassidy. But let us assume that because--I have
heard from people within the agency that, in reality, people
are only required to come in 1 day out of a month, and this has
been something we have heard from CDC along those lines, but I
have also heard from somebody who is working at CMS. Now, I
assume that you have a global policy, because you have the same
union negotiating for all of HHS. So it seems to me as if it is
going to be the same policy wherever you are.
So my question is, if you are working from home
consistently, and originally you were based in DC, are you
still getting a cost-of-living adjustment, even though we
frankly do not know what, where--you might be flying in 1 day a
month, but living in West Virginia.
Secretary Becerra. Again, Senator, I am not familiar with
this statistic that you are throwing out that says----
Senator Cassidy. But is there a cost-of-living adjustment
for people who are taking advantage of ``generous telework''?
Secretary Becerra. There is certainly a cost-of-living
adjustment for folks who work in high-cost areas.
Senator Cassidy. Even if they are teleworking?
Secretary Becerra. If they are performing their work, they
are entitled to receive a cost-of-living adjustment if they
work in a high-cost living area.
Senator Cassidy. And when you define ``work in a high-cost
living area,'' do you mean telework? I mean they could be--
their VPN could show them in DC, but they could be in West
Virginia. So are they getting paid as if they are living
physically and showing up every day and parking in that parking
lot every day in the DC area?
Secretary Becerra. So, you would have to take a look at the
particular job description to find out what type of work is
done and where they are located to be able to make that
determination.
Senator Cassidy. I yield.
The Chairman. I thank my colleague.
Next is Senator Hassan.
Senator Hassan. Well, thank you, Mr. Chairman and Ranking
Member Crapo, for having this hearing, and thank you, Mr.
Secretary, for being here.
I want to start with a discussion of State opioid response
grants. I was really pleased that the Department's proposed
budget includes $2 billion for State opioid response grants.
These grants, which I have worked since 2017 to secure and
expand, have really helped my State significantly improve our
response to the fentanyl crisis.
Last year, you and I discussed this program's impact in New
Hampshire. New Hampshire's been really hard hit by the fentanyl
crisis in particular. We discussed the importance of continuity
of funding, because it helps States plan and avoid drastic
cuts. Just before the hearing, we were talking about a program
in Rochester, NH called Hope on Haven Hill, which focuses on
treatment, recovery, and transition for pregnant moms and
parenting moms who have substance use disorder. The continuity
of funding has been really critical for them to be able to
develop that program and really help these women turn their
lives around and get better.
So, in last December's appropriations bill, Congress acted
on a bipartisan basis to require HHS to, and this is a quote,
``prevent unusually large funding changes from year to year in
these grants.'' I know from our past conversations that you
understand and share this really important goal. How does HHS
plan to implement this statutory requirement to prevent year-
to-year funding cliffs in State opioid response grants for
States like New Hampshire?
Secretary Becerra. Senator, first I have to say ``thank
you,'' because in many ways these are your babies, these SOR
grants. You have championed them, and you have made it possible
for us to actually get money into communities that need to deal
with opioids. And you are saving lives, so thank you for that.
The President has followed your lead. He is calling for
some $2 billion in investment. That should help a lot of these
agencies that are administering the funds to get services to
folks who are trying to get off of opioids, a way to know that
they are going to have a consistent and hopefully permanent
stream of support, because the last thing you need is to be
there one day, but not the next.
The work that you all are doing is helping us not only make
sure that we institutionalize these programs under the SOR
grant program, but that we also make sure that it stays
consistent, so that we do not have one day you have the
resources to do it, and the next day you have to close down all
these shops. But we will work with you on that.
Senator Hassan. Well, I appreciate that. I really just
wanted to make sure that your staff and mine will continue to
work on this. It is everything from certainty and
predictability for patients, as well as being able to recruit
people into the workforce to do this work, right? So I look
forward to working with you and your staff on that.
Secretary Becerra. Thank you.
Senator Hassan. Now I want to turn to discuss title X
family planning funding. I want to thank you for including
robust funding for maternal and reproductive health in the
Department's budget, including doubling funding for title X
family planning to $512 million. Along with Senator Warren, I
am leading a letter to appropriators echoing that request.
Title X is the only Federal program dedicated to providing
family planning, and it has historically been a program that
has been underfunded. But we all know that in light of the
Supreme Court's decision last year to restrict women's
reproductive freedom, this is a program that is more essential
than ever. So can you speak to the importance of Congress
appropriating this essential title X family planning funding,
and then I want to ask you one more question, so if you can, be
a little bit brief.
Secretary Becerra. Family planning has not received a boost
in funding in 8 years. It is time. We know how essential it is.
It is not just funding for one type of care; it is funding for
family planning services--indispensable. The President's budget
recognizes it. We look forward to working with you to get that
across the finish line so we can actually expand services and
get them to communities that absolutely need them.
Senator Hassan. Well, and it is absolutely essential to a
woman's capacity for self-determination and dignity, so I
appreciate it very, very much.
I want to turn to one other issue, which is the MAT Act
implementation. At the end of last year, the Mainstreaming
Addiction Treatment Act, MAT, which I led with Senator
Murkowski, was signed into law. This bill eliminates needless
outdated restrictions on health-care providers that prevented
them from prescribing buprenorphine, a critical treatment
option for people struggling with fentanyl and other opioids.
I know that you, and the administration more broadly, are
strongly behind this new law, and I really want to thank you
for your and your colleagues' work to support it. Can you
please speak to the importance of these changes and what HHS is
doing now in coordination with other agencies to expand access
to buprenorphine by ensuring that health-care providers know
about these changes?
Secretary Becerra. Senator, gosh; where do I start?
Medication-assisted treatment is critical, because it is one of
the ways you save a life. If you give buprenorphine to an
individual before they OD, you have just saved a life. If you
can try to remove the barriers that kept a physician from
participating in a program to be able to prescribe a lifesaving
drug, you saved a life. When we were able to really remove the
X waiver cap, we were able to make it more likely that a
physician would want to participate in this program and not
find themselves subjected to law enforcement oversight as if
they were encouraging drug use.
What we did was, we liberated the system to actually treat
drug addiction and take away the stigma. So we look forward to
working with you on that.
Senator Hassan. Well, I look forward to that too, and
just--I am over time. But one of the critical things here could
be making sure that we work with law enforcement, as well as
health-care providers, to stock buprenorphine in pharmacies,
and make sure that primary care physicians and other primary
prescribers know that they can prescribe this lifesaving
medication.
So, thank you. I look forward to continuing to work with
you.
Secretary Becerra. Thank you.
The Chairman. And thank you for your work, Senator Hassan,
especially on title X, an enormously important program--and it
has not come up yet today.
Senator Johnson, you are next.
Senator Johnson. Thank you, Mr. Chairman. Secretary
Becerra, welcome.
Do you believe it is important that we understand how the
coronavirus originated?
Secretary Becerra. Absolutely.
Senator Johnson. Is there somebody in your agency, your
department, who is spearheading the investigation to determine
that?
Secretary Becerra. We have done a number of--taken a number
of initiatives to try to move forward there, including having
OIG take a closer look.
Senator Johnson. So you are saying it is the OIG? I mean,
is there somebody within the Department outside of the
Inspector General that is spearheading this, somebody in
charge?
Secretary Becerra. CDC and NIH are also doing a scrub. We
are all trying to get as much information--the difficulty is
that we are not getting a lot of cooperation from some of the
sources externally that could probably give us----
Senator Johnson. Well, let us talk about lack of
cooperation, because I would say the same thing is true in
terms of cooperation out of the agencies. Do you believe the
public has a right to know how the agencies are spending their
money and how they are operating?
Secretary Becerra. The public does have a right to know,
yes.
Senator Johnson. There are two primary methods for that.
You have FOIA, Freedom of Information Act requests, and then
you also have congressional oversight. Would you agree that
FOIA is generally subjected to more redactions than
congressional oversight would be?
Secretary Becerra. I would not say that, but we do have to
be careful what goes into the public domain with respect to
confidentiality and privacy.
Senator Johnson. I understand. There are some exceptions
that are very explicit out there, and a lot of them make sense.
But I would argue, I think many people do, that congressional
oversight really is not subject to those same redactions,
particularly when we have security clearances, and we can take
a look at classified information that is appropriately redacted
under FOIA.
Let me give you a couple of examples. We requested these
documents. [Holding up pages.] By the way, in June of 2021,
under a FOIA request--court-ordered--4,000 pages of different
documents, primarily emails of Anthony Fauci, were produced
under the FOIA. In September 2021 we--well, that month, we had
five members of Homeland Security and Governmental Affairs ask
for those same pages unredacted, and there is a law that says
you shall turn that over to us.
In September 2021, we started working with HHS to produce
those documents in an accommodated process. So we narrowed the
4,000 pages down to 400 to get those things unredacted. They
were not handed over to us. What we did--we were allowed to
read them 50 pages at a time in a reading room and take notes.
Some productions we did get. For example, we got this document
dated February 4th, between Anthony Fauci, Jeremy Ferrar of the
Wellcome Company, and Francis Collins. You see the redactions
here. This is the same document produced under FOIA without the
redactions.
So now we know what was redacted, and this was redacted, by
the way, under (b)(4), which is trade secrets. One thing that
was redacted here is Anthony Fauci saying, question mark,
``serial passage in ACE2 transgenic mice,'' in other words,
humanized mice. They were talking about--Ferrar is writing to
Francis Collins. ``Remains a very real possibility of
accidental lab passage in animals to give glycans.''
He said that ``Eddie thinks it's a 60-40 lab side.'' Ferrar
said he thinks it's 50-50. Again, this is February 4th. There
is nothing to do with trade secrets in that redaction.
Another example. This is February 2nd. Again, this is with
their understanding that they funded this dangerous research,
and now they are into cover-up mode. Here is what we got in our
production, the heavy redactions. [Holding up document.] This
is what was released under FOIA. [Holding up document].
Now this was released under the (b)(5) exception, which is
privileged information within or between agencies. Again, this
is with Jeremy Ferrar of the Wellcome Trust. So we have
redactions with--you know, privileged information did not
apply, and we still had it redacted. I do not have time to get
into that. This is completely inappropriate, and by the way we
are down--you have produced 350 pages to us in the reading
room. For over a year, we have been asking for the last 50
pages. This is what the 50 pages looked like, okay? [Entire
pages are blacked out.]
Now again, I would argue congressional oversight should not
be subject to the same redactions that were applied under a
FOIA request. I am asking you: will you commit today to provide
for our oversight--now Senator Paul is on this. Again, we had
five members of Homeland Security and Governmental Affairs,
under a law that says you shall provide this. Will you commit
to provide us the last 50 pages of communication between
Anthony Fauci, Francis Collins, Jeremy Ferrar, as it relates to
the origin of the coronavirus? Will you commit to that?
Secretary Becerra. Senator, I absolutely will commit to
make sure we follow up with you on your request to get some of
that information. Again, this is in compliance with the law
that you received the information. I do not know what
particular statute with regard to disclosure was applied here,
but you are absolutely entitled to the information that by law
a member of the Senate or the House could get to follow up----
Senator Johnson. Yes. But again, you are not complying with
the law, because you are redacting things, for example under
the deliberative process between and within agencies, and it is
communication outside of the agencies with the Wellcome Trust.
Again, these redactions are not complying with the law. So
again, I will appreciate--we will follow up with you. I expect
to see the unredacted 50 pages very soon.
Secretary Becerra. We can comply with the law, Senator, but
we absolutely will make sure we follow up with you.
The Chairman. Thank you, Senator Johnson.
Next is Senator Cortez Masto.
Senator Cortez Masto. Thank you, Mr. Chairman. Mr.
Secretary, it is always great to see you. Thank you.
Before I get to my questions, I do want to quickly touch on
Medicare Advantage. Seniors in my State rely on Medicare
Advantage to access affordable, high-quality health care. I
often hear from Nevadans how vitally important this program is
to supporting their health and the health of their loved ones.
That is why I have long been a supporter of Medicare Advantage.
This year, I am proud to have led the annual bipartisan letter,
and I believe there were 57 Senators, my colleagues, who signed
onto the letter urging the administration to preserve and
strengthen the program. Last week, I spoke with CMS
Administrator Brooks-LaSure about the proposed updates to the
program for 2024 and what they mean for Nevadans.
And I will just reiterate today, Mr. Secretary, that any
efforts to address overpayments in Medicare Advantage should
support program integrity and preserve the sustainability of
the entire Medicare program without disrupting access, without
increasing cost or jeopardizing the quality of care. So, as you
move to finalize 2024 policies, I urge you to prioritize the
program improvements that benefit patients and deliver value to
seniors and taxpayers. So, I just wanted to start with that.
Secondly, I too noticed all the purple here in the room.
Thank you to the Alzheimer's Association, everybody who
advocates. It is something that I dealt with within my family
with my grandmother. I appreciate your advocacy over the years.
Thank you. You always have a supporter with me.
Secretary Becerra, let me talk about the commercial
prescription drug inflation rebates.
Last year, as you well know, we passed historic drug
pricing policies in the Inflation Reduction Act. This law is
already working to lower drug costs for our seniors with
Medicare. Importantly, the Inflation Reduction Act penalizes
drug companies for raising prices faster than inflation.
However, as it stands today, these companies are only held
accountable for hiking drug prices in the Medicare program.
That is why I am introducing a bill to extend the inflation
rebate penalty to include drugs used by people with private
commercial insurance. My bill will ensure that Nevada families,
as well as our seniors, are no longer squeezed by drug
companies' outrageous price hikes.
Secretary Becerra, I am glad to see the goals of my bill
reflected in the President's budget proposal. How would the
inflation rebate penalty for the commercial market impact drug
prices for patients at the pharmacy counter, as well as health-
care payers like employers and unions?
Secretary Becerra. Senator, well first, thank you for that
effort. We want to help any way we can, because we know what
happens--take insulin. Insulin was only to apply to those who
were on Medicare, 67 million Americans on Medicare. Today, the
three leading manufacturers of insulin have said they are going
to drop their price of insulin for those who are not on
Medicare, so those in the private insurance market.
And so we see what happens when you introduce competition
into this. The prices come down, because everybody now has to
compete to get your business. Your bill, I suspect, would do
the same thing. It would introduce that competition in the
private insurance sector that would complement what we do in
Medicare, and the end result is, you drop the price for a whole
lot of Americans who are not on Medicare.
Senator Cortez Masto. Thank you, I appreciate that. And let
me just add that my commercial prescription drug inflation
rebate bill has the potential to generate significant savings
for the Federal Government. In fact, CBO projected that a
similar provision would save $34 billion over 10 years. So, I
thank you.
Let me jump to something very quickly here as well: mental
health. I have heard my colleagues here talking about this. As
you well know, this is such an important issue for me as well,
and I support my colleagues on both sides of the aisle for
working to address this. I appreciate the support for the
crisis services in the budget proposal around mental health in
the Fiscal Year 2023 funding bill, the significant expansion in
funding for 988. The new suicide and crisis lifeline has helped
communities manage increased demand in call volume since the
line went live last summer.
I know; I talk to my folks in Nevada all the time about
this. On this committee, we are very focused on what comes
next, what happens when someone in crisis dials the line and
needs somebody to come help or somewhere to go for that
treatment. I was proud, with the chairman, to pass increased
funding for 988 and crisis care through mobile units in the
December omnibus bill, but we have more work to do.
My question for you is, in your view, what is the biggest
challenge to improving crisis care coordination when we are
talking about the mental health support that is needed across
the country?
Secretary Becerra. Senator, workforce. We need to hire up
more folks, pay them decent wages so they will stay in the
field, because right now we know that health care has a
shortage of workers period, but mental health is even worse.
So, if we really want to say to somebody ``call 988 and you are
going to get real help,'' we have to make sure that there
really will be real help at the end of that call.
Senator Cortez Masto. I look forward to working with you,
because I am hearing the same thing. I see it in my State and
across the country; so, thank you.
Secretary Becerra. Thank you.
The Chairman. I thank my colleague for her questions, and
especially the points about MA, Medicare Advantage. We have
worked very closely on this committee with Chairman Casey, who
has also put in a lot of effort on this at the Aging Committee.
Just a quick word. I believe Oregon, Nevada, and Minnesota
have the highest percentage of senior citizens in MA in the
country. And having spent a lot of time in these precincts
since my days working with seniors, I have come to the
conclusion that, unfortunately, not all Medicare Advantage is
created equal.
There has been some very good MA, there has been some not
so good, and we are going to work very closely with our
colleague to make sure we get the former and have less of the
latter, because her points are very well taken. We are going to
work closely with the administration to make sure that we
recognize that kind of distinction, and I appreciate her
comments.
Next is Senator Tillis.
Senator Tillis. Thank you, Mr. Chairman. Secretary Becerra,
thank you for being here.
Before I make some comments or questions, I also want to
recognize the Alzheimer's Association. You all were in my
office, the North Carolina delegation was in my office
yesterday, and my staff have been meeting with them. I looked
at my staff and said, ``Are there any priorities that they have
discussed that we do not support?'' They said the answer is
``no.'' We support them all, including a ``dear colleague''
letter for funding for NIH. So you can count on my support. But
the reason I did that is because I wanted to talk with them
about something that should be on your agenda, and it relates
to research, and it relates to prescription drug pricing, and I
will get to that in a minute, because I want to use a few
examples.
I know that we have had some members talk about the great
advances, Secretary Becerra, in the Inflation Reduction Act. I
think, based on patterns that I am seeing in the industry, you
could call it the Investment Reduction Act. Mr. Chairman, I
have three documents that, without objection, I would like to
submit to the record.
The Chairman. Without objection, so ordered.
[The documents appear in the appendix beginning on p. 179.]
Senator Tillis. Two are related to Eli Lilly, one to
another player in the pharmaceutical space, that have said they
are making business decisions to drop small molecule research
and other things because the time that they would need to
recover the investment they anticipate is not there. So you can
expect reductions in small molecule research. You can expect
reductions in an eye drug that they were trying to expand.
You can see the effects of not getting well-intended policy
right, and Secretary Becerra, Congressman Becerra, I think the
work that you did on a bipartisan basis, whether it was the
21st Century Cures bill, or even more importantly, the heat
that you took from your side of the aisle to get Trade
Promotion Authority--tells me you are a person who likes to get
to a positive end, a productive end.
The only reason, the primary reason I did not support your
confirmation--in full disclosure--is the position you have
taken on march-in rights. And so, I am not going to have enough
time to get to many questions, but I think it needs to be said
that I believe we are going about it the wrong way in terms of
the haircut that needs to be done to get prescription prices
lower, not at a point in time and not at the expense of other
research and investment that is necessary.
I tell everybody in the industry I believe that there is a
haircut coming, but I have not heard any member talk about who
needs to be in the barber shop. I think it needs to be pharma;
I think it needs to be the pharmacy benefit managers. It needs
to be insurers--I just wrote this down as notes--the medical
profession, the pharmacies, the FDA, and the legal community.
If you are really going to fix the fundamental problems with
drug pricing and look people in the eye and say you are doing
something not just to claim victory, as it was done with the
IRA, but something that is sustainable, every single one of
them needs to be there.
They are all a part of the value chain, they all need to be
at the table, and we need to get it right. Because you may be
able to correct me if I am wrong, but I have not seen a single,
successful, sustainable solution to this, or at least a part of
the solution, except when Bayh-Dole passed something not too
long ago. Now, Mr. Chairman, I would like to submit for the
record an op-ed that was written by Senators Bayh and Dole in
2002 that said they never intended for their legislation to
become weaponized.
The Chairman. Without objection, so ordered.
[The op-ed appears in the appendix on p. 179.]
Senator Tillis. And in spite of the fact that the NIH has
recently just rejected imposing price controls based on price,
now we have a work group that is going to consider price as one
of the ways that we go about getting down on this industry. If
we do it, we are going to have a longer window for work, the
very promising work that is being done for Alzheimer's.
I've got a vested interest in that. I was a part-time
caregiver to my grandmother. I've got a vested interest in
broader research. I've got two potentially deadly--one
incurable and one curable--diseases in my body. One is prostate
cancer, the other is Wegener's granulomatosis. Both of them are
being managed. Prostate cancer has a lot of promise, provided
that it is within that window. Wegener's is a rare disease. It
is not going to be something that we are going to see a cure
for, particularly if we do not get this right and incent the
private sector to invest in things where they may have to walk
away from it, like an Alzheimer's drug, after a billion dollars
in investment.
And so I told the Alzheimer's Association to please study
up on the attacks on intellectual property protections; take a
look at what the administration's done with TRIPS waivers and
other things, really threatening the return on investment that
these companies have to make; and please make sure that that is
a part of your pitch when you come to these members of Congress
and expect them to produce a prescription drug pricing strategy
that they can look you in the eye and say is going to produce
year-over-year results.
Thank you for being here.
The Chairman. Senator Tillis, thank you for your point with
respect to the nature of how pharmaceuticals, particularly as
it relates to the regulatory system, have a breakdown at every
step of the way. That is what Senator Grassley and I found in
our mammoth research report. If anybody is having trouble
sleeping tonight, you can go through the scores and scores of
footnotes, and it starts with pharma, but it is the PBMs, it's
the distributors; it is every step of the way.
Senator Tillis. And, Mr. Chair, it is the FDA too. We
learned so much from COVID, and we figured out how we could
accelerate approvals under emergency use authorizations. The
fact that we would have those snap back post-pandemic after
they have been proven to work, to me is meaning that we are not
learning some of the good things that came from that stress.
The Chairman. Your point is correct.
Senator Warren and then Senator Blackburn.
Senator Warren. Thank you very much, Mr. Chairman. I also
want to say ``welcome'' to the Alzheimer's Association. I wore
my Alzheimer's purple today. We have a very active group in
Massachusetts, and I just want to say a special ``thank you''
for all of the advocacy you do on behalf of so many people we
have lost to a terrible disease. So, thank you.
I want to talk today also about Medicare Advantage. You
know, every February, the Federal agency that runs the Medicare
program releases a report outlining how Medicare Advantage or
MA insurers are going to be paid for the following year. MA is
a program that allows private insurance plans to offer Medicare
benefits. Now taxpayers pay these insurance companies a set
amount per beneficiary, and this amount can go up if the
beneficiary is sicker.
The more diagnosis codes that a beneficiary has, the higher
the payment, and whatever insurers do not spend on care they
actually get to keep. These companies have built entire
businesses around making beneficiaries look as sick as possible
and, unsurprisingly, government watchdogs have discovered
widespread abuse. This year, CMS made a few updates to ensure
that the government's payments more accurately reflect what it
actually costs to pay for the care for beneficiaries in this
program. And in response, the insurance industry has kicked
into overdrive, sending an army of lobbyists to claim that the
changes will hurt Medicare.
So let us go through this. Let us start with the basics,
Mr. Secretary. Under your proposal, will total payments to
insurance plans that run Medicare Advantage go up or down?
Secretary Becerra. Total payments will go up.
Senator Warren. So they will go up. CMS is proposing to
increase payments to MA plans next year. In other words, the
insurance companies overall are going to get more taxpayer
dollars, not fewer. But insurance companies want a lot more
taxpayer dollars, not just a little more, so they are kicking
and screaming, and they even shelled out millions of dollars
for a prime time Super Bowl ad opposing the proposal. Now these
Medicare Advantage companies are also peddling industry-funded
studies that claim Medicare premiums would go up and benefits
would be cut if your proposal is finalized. Mr. Secretary, are
those claims accurate?
Secretary Becerra. No, they are not. Benefits are not cut.
Senator Warren. All right. So numerous experts agree with
HHS's assessment. When Medicare Advantage was created, the
insurance companies argued that they could provide better care
than the Federal Government at a lower cost. But for years now,
MA plans have been using a long list of tricks and games to
take advantage of loopholes in the government's payment rules,
to squeeze literally hundreds of billions of extra dollars out
of the program.
Researchers at the Kaiser Family Foundation found that
profit margins for MA plans are double those for other kinds of
insurance. In other words, because of lax rules, running
Medicare Advantage plans is a lot, lot more profitable than
running any other type of insurance plan, and the insurance
companies do not want the party to end.
Mr. Secretary, are the private insurance companies that run
Medicare Advantage actually delivering health care for seniors
at a lower cost than the traditional Medicare program run by
the Federal Government?
Secretary Becerra. The numbers show that it costs more to
provide care to seniors in Medicare through the managed care
Medicare Advantage program than through the traditional program
called fee-for-service.
Senator Warren. So the cheaper way to do this is actually
just to run people through the Medicare program. That's not to
say there are not some programs that work with Medicare
Advantage, but overall, that is what the data show?
Secretary Becerra. Yes. We are talking overall. So, if you
lump everyone who is in the Medicare Advantage program, the
managed care program within Medicare, and those who are in the
traditional Medicare program called fee-for-service, the per-
beneficiary cost is higher under managed care or what we call
Medicare Advantage.
Senator Warren. Exactly the reverse of what they promised
they would deliver. They said, ``Hand it over to us, and we
will do this cheaper.'' You know in fact, according to the
Medicare Payment Advisory Commission--which is the independent
congressional agency that studies Medicare--the private
insurance companies running MA have never delivered health care
at a lower cost than traditional Medicare in the entire history
of the program.
So I just want to say, I urge CMS to finalize this
proposal. I cannot get an ad on the Super Bowl, but I hope that
having you at this hearing will have some influence on this. It
is important to take these steps to strengthen Medicare. I also
want to say I do not think it is enough. CMS needs to double
down on its efforts to crack down on industry abuses in the MA
program. I stand ready to work with you and to help you do
that, to ensure that Medicare beneficiaries get the care that
they have rightly earned. Thank you, Mr. Secretary.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Warren.
Senator Blackburn?
Senator Blackburn. Thank you, Mr. Chairman. And, Mr.
Secretary, thank you for being here. I am so grateful we have
the Alzheimer's volunteers here. We have a great group in
Tennessee, and so--there are some back there. Love seeing them.
But you know, Mr. Secretary, the budget that you brought to
us, it is full of things that get in the way of research. It
would prevent new drugs and therapies from coming to market. It
would weaken those IP protections, and it would expand the
government, and it is something that does cause us some
concern.
I want to return to the issue of telework. I know that
Senator Cassidy discussed this with you. Adding to the list of
how many HHS employees are working through telework, I would
like for you to identify the essential and non-essential
components of that list of those who are teleworking. And also,
looking at you and your team personally, when you look at
telework, how many days have you spent in California during
COVID-19?
Secretary Becerra. Thank you, Senator, for the question.
With regard to my status, I know that requests have been made
for my schedule, and we will try to provide as much information
as we can.
Senator Blackburn. Yes. I think it would be great if we
were able to get the schedule for you, your security detail,
and the records, expense reports, so that we could see how
much--the reason this is important is because you are
overseeing an agency that is the equivalent of a tenth of our
Nation's GDP, and I think that it is vital that you be on site
in overseeing that department. So, can you even ballpark how
long you were in California and how often you were absent?
Secretary Becerra. I do not get to California very often.
When I do, it is usually because I am doing work, and I
travel----
Senator Blackburn. During the pandemic, because I think it
is important that during the pandemic that you were there. And
I want to read this back to you. In 2019, talking about the
border crisis, you said of President Trump, and I quote, ``And
to say that is an emergency and then within 24 hours of having
said it, go off to Florida to your Mar-a-Lago resort, when you
think there is a national emergency. I think all the evidence,
including what Donald Trump says and does, proves this is no
national emergency.'' So, by your own standard, you would
equate COVID to not being a national emergency if you are
spending those hours in California and being absent from the
headquarters. It is time to get people back to work.
Faith-based organizations. We have 8,000 faith-based
organizations across the country that are irreplaceable members
of the Nation's child welfare system. Senator Ossoff and I are
going to do some bipartisan work at the Judiciary Committee on
these issues. Tennessee relies heavily on faith-based agencies
for services like foster care, adoption, different child and
family services, and the recruitment of those adoptive
families.
Now, under your leadership, one of the first actions that
HHS took was to rescind waivers issued by the previous
administration, which allowed faith-based groups to place
children with families in accordance with their sincerely held
religious beliefs. The President's budget now proposes to
combat sexual orientation and gender identity discrimination by
penalizing foster care and adoption providers for operating in
accordance with the tenets of their faith.
So, with nearly 400,000 children in the foster care system,
would you not agree that placing those kids in loving homes is
a greater priority than advancing an agenda?
Secretary Becerra. Senator, thank you for the question.
There is no doubt that being able to place any child who is in
foster care in a loving home should be our top priority, and we
want to make sure that that is always possible. We want to make
sure laws are not violated that would prevent that child from
going to a loving home.
Senator Blackburn. Then let us do this. Let us have you
submit how many potential foster and adoptive homes would be
forced out of the system if the President's budget were put
into effect on that issue.
I want to go back--I know Senator Menendez talked to you
about the Office of Refugee Resettlement, and this department
is responsible for the care and placement of unaccompanied
children who come across the U.S. border; correct?
And are you aware of the recent New York Times article that
really reported on the large numbers of unaccompanied children
who are being placed with exploitative sponsors and working
long hours in dangerous conditions?
Secretary Becerra. I am aware of the fact that a number of
children have been reported to be working in ways that are
violating our law, but I am not aware of the situation you
mentioned about being placed in exploitative circumstances. So,
if you could clarify that a bit more for us.
Senator Blackburn. I will be happy--Mr. Chairman, I would
love to submit that article for the record.
The Chairman. Without objection, so ordered.
[The article appears in the appendix beginning on p. 165.]
Senator Blackburn. That is wonderful. Thank you for that.
Now the agency--The Times reported that under the Biden
presidency, the agency cannot find 85,000 children, and that
the agency lost contact with a third of the migrant children
who are coming into the country. So I would like to know what
you are doing to find the children and what you are doing to
make certain that these children are not being trafficked?
Secretary Becerra. Senator, first, those statistics that
you have mentioned--as I said previously in regards to another
question by one of your colleagues--is those are unfamiliar to
me. I have no idea where those statistics come from, if they
are based in reality or not, and we do everything we can to
make sure any child, before we allow them to be released to a
sponsor, that that sponsor has been vetted. The vast majority
of these children end up with a family member, an immediate
family member, as a placement. So some of those statistics that
are being thrown out there that do not seem to be based in
fact, really would go contrary to what actually we have done.
Senator Blackburn. Okay. My time is over, but let me tell
you, we have to get this thing straightened out. At any time,
you had 10,500 children under your care; the money works out to
about $1,400 a day to take care of these children, and you
cannot find these children. We have to get it straightened out.
Thank you, Mr. Chairman.
The Chairman. I thank my colleague. We are going to go to
Senator Daines.
I am just going to put one document into the record.
Reference was made of how the notion, according to some, of
making sure Medicare can bargain to hold down the cost of
medicine would somehow reduce innovation and damage future drug
creation. The nonpartisan Congressional Budget Office looked at
this issue specifically, and estimated, their words, ``minimal
impact of new medicines coming to market under Medicare drug
price negotiation.''
This was an issue very important to me, because clearly
what we wanted was more competition without reducing
innovation. That was the finding of the nonpartisan
Congressional Budget Office.*
---------------------------------------------------------------------------
* Congressional Budget Office, Cost Estimate, September 7, 2022,
https://www.cbo.gov/system/files/2022-09/PL117-169_9-7-22.pdf.
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Senator Daines?
Senator Daines. Mr. Chairman, thank you. Mr. Secretary,
thanks for being here today.
There are several concerning proposals in this budget,
including, yet again, the omission of the Hyde Amendment, to
allow for
taxpayer-funded abortions. It is clear the administration has
no intention of protecting the precious lives of the unborn. In
fact, since the Dobbs decision was first leaked in May of last
year, over 80 pregnancy resource centers and pro-life groups
have been attacked and vandalized, as have hundreds of churches
that support the pro-life cause, some even in my home State of
Montana.
Mr. Secretary, given the continued assaults against
pregnancy centers and churches, would you publicly condemn this
violence? If you want to do it right here, I would be happy to
hear it.
Secretary Becerra. Senator, I do not believe anyone here
would condone violence against any American, whatever the sort,
and certainly I would hope that we could all work together to
prevent any American from being harmed simply because they are
either trying to exercise their rights or receive services they
might need. So I would love to join you in sending a message to
all Americans: please, respect people's rights, and also make
sure that we are not abridging people's rights.
Senator Daines. Would you publicly condemn what has
happened? Would you condemn this violence?
Secretary Becerra. I condemn any sort of violence against--
--
Senator Daines. Thank you, Mr. Secretary; thank you.
As you are aware, over 30 million seniors and people with
disabilities in this country enrolled in the Medicare Advantage
plans--including one quarter of Montana seniors--due to the
added choice and control they offer beneficiaries. Rural States
like Montana face unique challenges when it comes to recruiting
and retaining physicians. Oftentimes, we are a long way away
from larger communities, and the changes to the CMS HCC model
in the proposed rate notice will further jeopardize Montanans
access to care.
My question is this. What data can you provide that might
show that the current rate notice will not impede access to
care in rural and underserved areas?
Secretary Becerra. Senator, thank you for the question,
because it is very important. The rate notice actually provides
a greater level of funding than last year, and what we do is,
we try to make sure that it is funding that goes for a
particular service, and not to line the pocket of a middle
person in the process. What I will say to you--especially
because of the rural communities that you represent--is, we
need to make sure every dollar that the Medicare program puts
out for a Medicare recipient gets to service a Medicare
recipient.
What we are finding is that too often, programs are gaming
the system. And for example, as you heard earlier, some of the
plans are claiming that a Medicare beneficiary is sicker than
what the person may be as a result of upcoding that person. You
get more reimbursement, even though you may not provide the
care that a sick person under those circumstances would need.
But what I will tell you is that, at the end of the day,
whatever we have done with this rate notice, it does not cut
any benefit provided by Medicare, and in fact it actually
provides more resources to those who provide services under
Medicare itself.
Senator Daines. I want to shift gears and talk about
Medicare taxes. Mr. Secretary, the President's proposed budget
raises Medicare taxes, because the President claims to care
about the solvency of the Medicare program, and that the
wealthy should pay their fair share. However, there is mounting
speculation--and this is as reported in The Wall Street
Journal--that according to his own tax returns, the President
improperly classified the money he made on book deals and
speaking events, allowing him to dodge over $500,000 in
Medicare taxes. This is again according to The Wall Street
Journal.
How can the President propose tax increases on Americans
and call for the wealthy to pay their fair share, when he
potentially owes half a million dollars in taxes to the
Medicare program?
Secretary Becerra. Senator, let me respond on the Medicare
program. The President's budget would make sure that, not just
for today's seniors, that they would get the benefits they
expected when they paid into the Medicare program for decades,
but it actually now makes it clear that, moving forward to the
next generation, they would receive the same level of benefits.
There would be no cuts, and that's the beauty of the
President's proposal. He has figured out a way to do that.
Senator Daines. But the question is, do you not think this
pledge to protect America's seniors might ring a bit hollow in
light of the President's own hypocrisy of dodging $500,000 in
Medicare taxes?
Secretary Becerra. My suspicion, Senator, is that the
President would challenge the way you have described his
circumstance. But what you cannot challenge is the fact that
his proposal actually increases benefits under Medicare, and it
moves it forward in strengthening it for the next generation,
something that no other President that I have seen when I was
here in Congress for 24 years, had really done. And I have not
yet seen anyone in Congress really produce a plan like the
President's that would provide that guarantee for seniors of
tomorrow, that they will have the protections they expect under
Medicare.
Senator Daines. Mr. Secretary, I am out of time. We lost
our chairman.
Okay, it looks like Chairman Casey.
Senator Whitehouse. Chairman Casey is recognized by
himself.
Senator Casey. Thank you very much. Senator Whitehouse is
letting me go ahead of him, so he gets a lot of credit.
Mr. Secretary, great to be with you, and thank you for your
testimony and your enduring commitment to public service. The
members of the Alzheimer's Association are here. We are
grateful for your presence and the determined advocacy that you
bring to our offices year after year. We are grateful and will
continue to work with you.
Mr. Secretary, I want to talk to you about long-term care
in the context of two settings. I will mention one, but I
really want to ask you about the second. The first is in this
broader context of what can only be described as a caregiving
crisis when it comes to seniors, people with disabilities, and
I would include children in that as well.
We are in that crisis, and one of the paths forward I
believe--not the only one--but one of the paths forwards is
greater investment in home and community-based services, so-
called HCBS, for seniors, people with disabilities, and the
workers who do that heroic work. I have legislation to do that
that I know you are aware of, the Better Care Better Jobs Act,
and we have much to do on that.
But I want to set that aside for a moment and talk to you
about the other setting, which is the institutional setting:
long-term care, skilled care in a nursing home--by way of the
leading example--and in particular the Special Focus Facility
program that I have worked to oversee for a number of years, to
make sure that we are investing in oversight that is
particularly centered on those facilities that have had the
greatest problems.
When you look at that number, about 90 percent of nursing
homes are not on that list. That is the good news. The bad news
is, the 3 percent that are have real problems in terms of care.
I was pleased to see that there is a 39-percent increase in
funding for survey and certification activities of nursing
homes in the President's budget. I am grateful for that, but I
also think that more funding is needed to expand the Special
Focus Facility program. How would additional congressional
appropriations toward nursing home quality and oversight be
beneficial to better protect residents in these facilities?
Secretary Becerra. And, Senator, thank you for focusing so
much attention on this. While I think most Americans would say
it's great that the majority of nursing homes do not fall
within this program, there are some that do, and they are
Americans who are in these facilities, and we have to make sure
that we protect them. So the money that the President proposes
would help us do more oversight.
It would help us do the surveillance to find out if these
poor-
performing nursing homes are increasing services and improving
services, and it would let us take action quickly so we can
prevent a mishap, an accident, or perhaps death to occur in one
of these facilities.
Senator Casey. And I will submit a question for the record
with regard to the plans to revise the program, the Special
Focus Facility program.
My second and final question is about countermeasure injury
compensation. We know that 700 million COVID vaccines were
administered in the country, but there are instances where
there are injuries related to any vaccine. I know they are
rare, but they do happen.
I was encouraged to see that the HHS budget requested
significant increases in funding for administering two
programs: the Countermeasures Injury Compensation Program and
the Vaccine Injury Compensation Program. I have written to
Administrator Johnson at HRSA earlier this year about the
Countermeasures Injury Compensation Program, and I want to make
sure that we reiterate the message from that letter: that
individuals with these COVID-19 vaccine injury claims are
waiting too long for adjudication.
So we want to make sure that people are not waiting for
years for that kind of compensation. What additional resources
or authorities do you need in order to speed up the process and
respond to these claimants faster?
Secretary Becerra. Senator, your help in getting that money
across the finish line will be indispensable, because we do
need to try to move through those backlogs. One of the things
that we would do is, if we get additional resources, to try to
make some process improvements in trying to get those claims
through. So we would set up, for example, an injury table that
lets us better target who is being harmed, what the issue is,
and whether or not they qualify for some compensation.
But the biggest issue right now is just having the
wherewithal, the resources to get through the number of cases,
because all these Americans deserve to be compensated if they
were injured.
Senator Casey. Thank you, Mr. Secretary.
Senator Carper. Mr. Secretary, your friends and admirers in
the First State send their best. Thanks very much for joining
us today.
Last year Congress passed, and President Biden signed into
law, the Inflation Reduction Act, as you know. It was not just
the most significant climate legislation in this country's
history, but also included landmark provisions to lower the
high cost of many prescription drugs. I was happy to join a
number of my colleagues in authoring those provisions.
But our work to lower drug prices, as you know, is not
done. We have a real opportunity to continue tackling the cost
of prescription drugs through the reforms to the pharmacy
benefit manager system. There is bipartisan interest on this
committee--and outside of this committee--to do so.
My colleague--our colleague and friend Senator Lankford
brought up, I believe, PBMs earlier while I was in another
hearing, and I want to follow up on his question. What common-
sense PBM reforms do you think should Congress--and in
particular this committee, the Finance Committee--consider that
will lower the cost of prescription drugs for American families
further, and will you and your team at HHS work with us to move
those reforms forward during this Congress?
Secretary Becerra. Senator Carper, thank you for the
question, and as you know, this is an area where whatever move
or change we make, we probably will find ourselves facing a
complaint filed in court. There is money involved in this.
But what I will tell you is that transparency is so
critical, to know how these middlemen are operating, so we
understand where the money is going and how the drugs are
getting to people who need them from the manufacturers. So I
would say to you that we are going to try to do the work
possible to try to increase oversight and transparency of the
way PBMs operate.
Senator Carper. Thank you, sir.
I want to talk a little bit with you about implementation
of the youth mental health provisions. When I was privileged to
serve as Governor of Delaware, we put a public-school nurse in
every public school. We opened up wellness centers in just
about every high school in our State. Now we are extending
those, as you may recall, to our middle schools and to our
elementary schools.
But throughout the 8 years I was privileged to serve as
Governor, we focused on making sure that kids get the care that
they need where they are at, in many cases in schools. Last
Congress, I was co-chair, along with Senator Cassidy, of the
Youth Mental Health Working Group, alongside our colleague from
Louisiana. Several of our priorities were included in the
bipartisan Safer Communities Act, as you may recall, including
important provisions to make it easier for schools to provide
mental health services to students, and to get reimbursed for
those services under Medicaid, and I think maybe under the CHIP
program as well.
I understand that HHS is now in the process of implementing
those important provisions. I would like to say, ``Find out
what works and do more of that.'' In that spirit, could you
just share with us some best practices from States that are
doing a great job providing mental health services to students
in school-based settings, so that other States can learn from
their success?
Secretary Becerra. And, Senator, you are right. You
probably can identify a number of these programs that are
really having success.
What I will tell you is that we are trying to partner with
those that have really gone into the schools to provide kids
with access, early access to preventative behavioral health and
mental health services. One of the programs we have is Project
Aware, which really works closely with students to ensure that
we are reaching them when they are manifesting certain issues
regarding behavioral mental health.
The other thing we are really going to try to push--and
here is where we need the help of the States and Governors--is
to see if we can get Medicaid into the schools far more deeply
and quickly, because many of these kids would qualify for
Medicaid services.
Why wait until a parent applies and finds out that the
child is eligible to receive mental health services at a
doctor's office or a hospital when, as you mentioned, the
beauty of having a nurse at a school and maybe having a
behavioral health specialist at a school where you get
reimbursed through Medicaid funding for having those
professionals there, helps us get to those children quickly?
Senator Carper. Yes.
Last question is: Federally Qualified Community Health
Centers are up, as you know, for reauthorization at the end of
this fiscal year. As you noted in your testimony, the
President's budget includes a pathway to double the program
size over 5 years, and greatly expands its reach.
I was pleased to see the President prioritize community
health centers in his budget, as co-chair of the Senate
Community Health Center Caucus, with several beloved centers up
and down my State that provide critical health-care services to
my constituents. And my question, the last question, Mr.
Secretary, is, can you share your thoughts on maybe the top
three areas, the top three areas, where Congress should focus
when it comes to reauthorizing the Federally Qualified
Community Health Center program?
Secretary Becerra. Well, the community health centers
really delivered. They saved lives. Tens of millions of
Americans got their COVID shots at community health centers.
They are the centers that are oftentimes providing dental
health services to Americans who otherwise don't have dental
insurance.
And so, the two or three top priorities: expand them. There
are parts of rural America that do not have good access to
community health centers. Let them expand their services. Some
do not provide OB/GYN services because they are expensive. And
at the same time, please, please pass the President's budget on
community health centers, because we expand the scope of
community health centers and their funding so we can continue
to have those great successes for so many Americans.
Senator Carper. Good. Thank you so much.
Mr. Chairman, I am Tom Carper, and I approve that message.
The Chairman. Very, very, very good, and we are glad you
are on the committee; so, thank you.
Senator Whitehouse?
Senator Whitehouse. Thanks very much. Thank you, Mr.
Secretary, for being here.
As usual, I want to bring up my graph, which we have
updated to show that from the original CBO Federal health-care
cost projections, this actually happened [pointing], with a
spike obviously for COVID here, and that brings us up to today.
In that backward-looking period in the past, that is an actual
$2.2-trillion savings in health-care spending below what CBO
forecast.
And, if you bring the forecast forward, in the next 10
years, the budget period, the projected savings are $6.9
trillion against the extended earlier CBO projections. So that
tells me that something is going on out there, and I think that
it has a lot to do with the improvements in the quality of
care, the move to value-based care, the success of Accountable
Care Organizations, and perhaps also some of the
pharmaceuticals that have come our way.
But I do think that this is worth taking a good, hard look
at, because, if we can get those kinds of savings out of the
health-care system without taking away benefits, we should be
all over that. I know for sure that the ACOs in Rhode Island--
Integra and Coastal Medical--hit it out of the park and
produced significant savings, wrote big checks back to
Medicare, and their patients loved it because the patient
experience got so much better. So, I commend that point to you
as I always do, and I hope we can make more progress there.
I also want to go back to something that I have referred to
you before, which is my efforts to try to get an end-of-life
care model set up in Rhode Island, using the CMMI pilot. I am
not asking the rest of the world to come with us, just let us
try it. We have been working for years.
This began under CMMI Director Boehler, and then when he
left, it was Groundhog Day, and we started in with his
successor. And then the administrations changed; it was
Groundhog Day again, and now it is Liz Fowler. The thing that
we have been asking for is a pool of waivers that really relate
to things people near the end of their lives can use.
The 3-day rule--it is preposterous to take somebody who is
within perhaps weeks or months of dying and the family thinks
they need to be at a nursing home, and you insist on 2 nights
and 3 days in a hospital on the way there? That is frightening;
that is expensive; that is, you know, just unjustifiable. So we
would like to see that waived for people who are in that
category.
Curative and palliative ought to be able to proceed in
parallel, and home health resources ought to be available. If
you are towards the end of your life but you can still walk out
into the garden, that should not bar you from getting home
health services, because going elsewhere to get the services is
more expensive and cruel to the family. So I really want to try
to land this and try to get CMMI to say ``yes.''
The 3-day rule you have already agreed to under COVID. It
was waived for COVID. The curative/palliative distinction you
waived for the Medicare Choices rule. The home health services
you waived for CMMI models. So it is not as if I am asking you
to do things that are not sensible and eligible and ready to
go. I just want a package so we can land this program in Rhode
Island that I have been working on, I think, now for 8 years.
Would you please help me with that?
Secretary Becerra. Very persuasive, Senator. Very, very
persuasive. And absolutely, let me work with you on that,
because as you said, many of these items are already in place
or have been used.
Senator Whitehouse. Yes, yes.
Secretary Becerra. And I think everyone----
Senator Whitehouse. And CMMI says ``No, you should do it
our way.'' No. Just do it our way, right? We are going to be
the pilot. We will put it all together. We will make it work.
You can measure and model us. We will work with the ACOs, and
we will do whatever they want, but I have had enough Groundhog
Days.
Secretary Becerra. Yes. Let us follow up, because I think
CMS would like to get there as well. Again, we are heading in
that direction, so let us see if we can get there with a good
model.
Senator Whitehouse. Thank you.
And just because I see all the terrific purple shirts in
the back--my Rhode Island Alzheimer's folks were in yesterday,
and they were eager to have Medicare approve lecanemab and
aducanumab for early onset Alzheimer's, and if there is
anything that you can do to help facilitate that, I think that
would be particularly helpful and welcome.
Then, last question, we would like to try to make sure that
medication-assisted treatment for people who have opioid
disorders can be accomplished through telehealth. We did that
through COVID. Can we please find ways to extend that, because
it seems to have worked very well, at least according to
everybody in my recovery and treatment community? That last
part was a question. Should we do more of that? Can we keep
doing that?
Secretary Becerra. Yes, and there, Senator, we will work
with you, because that goes beyond HHS. It goes into other of
our departments as well. So it is a joint effort to work on
that, and we can follow up.
Senator Whitehouse. Thanks, Mr. Chairman.
The Chairman. Thank you, Senator Whitehouse.
Senator Brown? All the chairmen are here.
Senator Brown. Mr. Secretary, nice to see you again. And,
Senator Whitehouse, thank you for your work, especially on
Alzheimer's. We also appreciate that.
Secretary Becerra, as you know, the Norfolk Southern
derailment in East Palestine--I was there again yesterday--has
left many community members with questions. They want to know
how the toxic exposure they and their loved ones experienced
will affect their health.
It is important in the process of searching for and
receiving answers about these effects that their concerns are
taken into account. I know some of your agencies have been
there since the very beginning, and you are aware of that, of
course. Thank you. I know that, moving forward, HHS will be
heavily involved. Yesterday, on one of my trips back to East
Palestine, I visited the mobile health clinic, set up and
partially funded by HRSA.
People are still coming in seeking help for symptoms
relating to exposure, and of course they fear for the future.
People are frustrated; they are scared. They feel like time is
of the essence. They are afraid when the cameras leave that the
help leaves. Can you assure me that HHS will continue to move
with urgency in response to this disaster?
Secretary Becerra. Senator, we were there from the
beginning; we are not leaving. And we have been on the ground,
and as you said, we have also provided resources, for example
to that community health clinic.
Senator Brown. Thank you, and I know that even though the
President did not go right away, or you did not go right away,
your people were there and made a real difference. Thank you.
I want to talk to you about drug pricing briefly. One of
the victories of the Inflation Reduction Act was capping the
Medicare copay for insulin at $35 a month. Walk through what
that means for an average Ohio senior who needs this lifesaving
drug.
Secretary Becerra. For the average Ohio senior, it is
probably about $500 they get to keep in their pocket; $500 just
like that, because before they were paying $100 for that
insulin a month, some paying up to $150, $200 a month. But on
average--so some will save much more, some will save maybe a
little less. But on average, every senior in Ohio who needs
insulin, $500 extra in your pocket this year.
By the way, if we had done this last year, that would have
been $500 last year you would have kept in your pocket, and the
year before. There is no reason why a drug that we know costs
no more than about $10 to manufacture should be costing seniors
$100, $200.
Senator Brown. Thank you. That was said so very well. Thank
you.
Switching gears for a moment, my last question, Mr. Chair.
I know there is a vote. Talk about Medicare Advantage, a great
program that serves millions of beneficiaries well. I am
concerned some seniors overpay and are not receiving the
benefits they deserve. Some Medicare Advantage plans
misrepresent how sick their patients are to CMS, in order to
take more money from taxpayers.
MedPAC says without fixing this, taxpayers and seniors will
be paying billions of dollars more than they should be. MedPAC
estimates it cost us over $20 billion--$20 billion--in 2023
alone. Seniors are literally paying for this in the form of
higher premiums. Fixing this sounds like a great way to save
money, but I keep hearing that saving this money is bad, that
it is going to hurt our seniors, put them in danger of having
their benefits cut. Explain to me why that is just not true.
Secretary Becerra. Well, Senator, it is not true because
there is nothing that we are doing in this advance notice that
would require any insurer to cut Medicare benefits. In fact,
they remain the same. Those benefits must be provided by law.
What we do is, we take out that extra charge, and we are going
to try to get back some of the money that we were overcharged
as a Medicare program that should have been used to provide
more services to Medicare recipients.
So we think it is the right thing to do, to make sure that
every dollar that someone paid in when they were working and
saw their deduction from their paycheck, is used to provide
Medicare once they are retired, not to help line the pockets of
those who are overbilling. We are going to go after any
overbilling where we can.
Senator Brown. Good, and I know you will, and your record
shows that.
So, thank you, Mr. Secretary, Mr. Chairman.
The Chairman. I thank my colleague. Before he leaves, I
just want to say ``thank you'' to Senator Brown, and then we
will go to Senator Young, because he remembers in 2019, when we
were in this room, and we were not going to be able to get
everything we wanted in that bill, we came up with an anti-
price-gouging strategy to protect consumers.
Just this week, we saw the fruits of that, because the
administration announced lower co-insurance payments for 27
drugs in Medicare Part B as a result of the penalties for price
gouging, and you see it particularly with drugs like Humira,
which is sort of a poster child for why you ought to have more
bargaining power. So, in this room, Senator Brown was
incredibly helpful with that, and I want to thank him.
Senator Young?
Senator Young. Thank you, Mr. Chairman. Good to be with
you, Mr. Secretary. Welcome to the committee.
The world is facing an antimicrobial resistance crisis. I
know you know that super-bugs make us all more vulnerable. They
undermine treatment of everything from common ear infections to
cancer treatments and routine surgeries. We are seeing more
resistance to infection right now than we ever have before, and
blessedly there has been a lot of public attention that has
been paid to this.
The antimicrobial market is failing. They are hard to
develop, and they are almost impossible to sell for at least 5
years because of the need to hold new antimicrobials in
reserve, to prevent resistance to those antimicrobials from
developing. The administration has stated that drug resistance
is a crisis, and the budget highlights a program to provide an
incentive for novel antimicrobials, similar to the PASTEUR Act,
which is bipartisan legislation that I have introduced with
Senator Bennet.
Just days later after the budget was submitted, CMS rolled
out a list of 27 medicines that the Inflation Reduction Act is
going to penalize for price increases. Five of them are
antimicrobials, with prices that are overall well below the
total expenditures of other classes of drugs, and they are
generally used for short durations for acute infections. These
are infused medicines, the kind that you get if there is
nothing else available to you.
So, Mr. Secretary, I am going to give you an opportunity to
tell me how will penalties on these antimicrobial medicines
help our super-bug crisis?
Secretary Becerra. First, Senator, you are the only one who
has asked a question about antimicrobial resistance, and I
thank you for that, because we do not think about it, but we
are losing the effectiveness of some of these drugs like
penicillin, and we count on them. But because they are being
overused or misused, we are losing the effectiveness of those
drugs. So, thank you for posing the question.
Secondly, remember that the only drugs that will fall on
this list to rebate back some of the money is drugs that were
raised beyond the rate of inflation, and they can't be new
drugs. So these are drugs that have been on the market, and
that manufacturer would have to explain why they had to
increase that drug beyond the rate of inflation, in some cases
dramatically beyond the rate of inflation.
So we are trying to be careful here, and we are going after
only those drugs where we see the prices being hiked
dramatically.
Senator Young. The price increases on these antimicrobials
are based on relatively low overall cost, compared to many
other disease treatments. I do not think that patients are
going to see much benefit from the penalties that are imposed
by the Inflation Reduction Act, if any at all.
It seems like a pretty arbitrary penalty to me that could
impact development of new antimicrobials, and you just
indicated we really need to develop them.
Secretary Becerra. And I would love to follow up with you
any way you would like on that, because you have touched on
something that is really important. We have to figure out a way
to have a consistent flow of new drugs that combat bacteria,
and as you mentioned, it is a tough business. There is not as
much money in it as you might think, and so definitely, I am
interested in following up with you any way you would like.
Senator Young. Well, I am interested in working together on
this. I know the administration, through their budget proposal,
has indicated they support something seemingly similar to the
PASTEUR Act. Maybe you can just share with the committee how
that proposal, you imagine, might strengthen the antimicrobial
pipeline.
Secretary Becerra. Part of what we think may be in the
solution is, rather than have a manufacturer produce a good
drug and now try to market it and depend on the market actually
receiving the drug and buying it, is maybe have more of a
subscription model, where what you do is, you say to the
industry, ``Come up with the drug,'' and like these
subscription services, Netflix and all the rest, everybody pays
in a little bit.
This way there is always money in the pot, and these
manufacturers have an incentive to go forward with their
production and creation of the drugs, because they know that
there will be money in the pot. Most of these manufacturers are
afraid that there will not be a market for their drug.
Senator Young. Sounds very similar to the PASTEUR Act, and
all the more reason we should work together on this moving
forward.
Mr. Chairman, if I can just add a very quick question about
organ procurement, something you have been such a leader on.
The Chairman. I was just going to commend you, because
yesterday we got some good news, that the administration is
going to be receptive to recommendations that you and others
worked with all of us on, to have a more competitive system and
not just give out the contracts. So I was just getting ready to
praise you.
Senator Young. Oh, well, thank you. Thank you for that, and
I will just pointedly ask the Secretary on topic here.
The Chairman. Please, please.
Senator Young. Getting OPO process data has been a real
challenge. The chairman and I have both requested this data. We
think it is consistent with our oversight responsibilities in
ensuring that more organs are available to save more lives and
extend lives. So will you commit to release OPO process data in
line with the bipartisan calls from this committee?
Secretary Becerra. Senator, we are working to change the
way we handle organ procurement and transplantation. We are
definitely interested in working with you on this subject, and
I do not know if you heard, but we just announced that we are
doing three specific things that are changing the dynamic in
this space.
We are going to call for more data transparency from the
contractors. We are actually going to open up competition for
the contract, so that the same contractor that has had this for
years and years does not just expect that they will get the
contract. Then we are also trying to--and the President's
budget calls for more resources to--actually modernize our IT,
because we are not keeping up with technology. We are losing
time, which could be letting an organ go to waste.
Senator Young. Those seem like the right priorities. I
would say that I hope the OPO process data is forthcoming,
consistent with the data transparency focus.
Thank you so much.
The Chairman. I thank my colleague.
Senator Barrasso?
Senator Barrasso. Thanks, Mr. Chairman. Mr. Secretary,
welcome back to the committee. Thanks for taking the time to be
here.
As you know, as a physician I know the importance of
protecting Medicare for future generations. And stopping waste
and fraud and abuse are critical for all of us, and it is a
bipartisan priority.
Late last year, I was joined by my colleagues on the
Comprehensive Care Caucus in sending a letter to CMS. The
purpose was to point out the proliferation of new for-profit
hospice providers. I think about the hospices in Wyoming, such
as Central Wyoming Hospice that I am very involved with in
Casper. We have some around the State of Wyoming--community
involvement, people volunteer, go to events, raise money, help,
and these are amazing centers that provide care and comfort and
compassion.
Most troubling is that your own data shows the
proliferation of these new for-profit hospices. They are
actually sharing the exact same addresses, and we are trying to
figure out what exactly is going on here, why this is
happening. Do you share my concern regarding this pattern of
this sudden growth of these Medicare-
certified hospices in certain parts of the country?
Secretary Becerra. Absolutely, and we have actually
conducted some unannounced site visits at some of these
hospices that were identified in that article.
Senator Barrasso. Yes. What are you finding out in terms
of--are there bad actors out there or are there things we can
do to curb them, so that we can prevent some of this waste,
fraud, and abuse?
Secretary Becerra. We will absolutely share some of that
information, but no doubt what we are looking for is to find
out if they are taking advantage of people, if they are
defrauding the American taxpayer, and if they are abusing the
privileges that they have by being able to provide these
services.
Senator Barrasso. You know, I point out there is a
bipartisan group on this committee--and in this body--that
wants to assist you in that and help you and share the
information that you come up with so we can put an end to this
sort of thing.
Secretary Becerra. As someone who cared for his dad,
giving, offering hospice care as best my family and I could, we
are absolutely with you on that.
Senator Barrasso. Thank you.
The next is, you know rural health remains a top priority
with me. We met today with the Wyoming Alzheimer's Association.
There are a number of people here in the audience today
listening to you testify, wearing the sashes representing
family members and others with Alzheimer's. So I am encouraged
that there is a new class of Alzheimer's treatments. It is
giving families some hope that they may have more quality time
with their loved ones before the disease takes hold.
It is not a cure, but there is hope there. And we just need
to make sure that what is available in certain locations could
also be made available to our Tribal communities and to our
rural beneficiaries. You know, the Centers for Medicare and
Medicaid Services, they have a policy for coverage that is with
evidence development, and they are requiring additional
clinical trials or registries that could create logistical
challenges for people in rural areas, as well as the providers
who are trying to take care of them, because they are not all
eligible, based on where they are.
So how does CMS plan to ensure that those with Alzheimer's
in rural settings and Tribal communities gain access to
therapies which are currently FDA-approved?
Secretary Becerra. And, Senator, I think this is where we
all would agree we have to do more work together. But COVID
taught us that telehealth flexibilities let us reach people
more directly, more efficiently. We would love to keep those
telehealth flexibilities in place. We would like to make sure
that an actual skilled, specialized provider is available in
these rural communities, so we are trying to expand the number
of people who actually go into the profession. But this is
where we can all team up together to figure out how we better
serve our communities, especially in rural America.
Senator Barrasso. And specifically, with FDA-approved
drugs, unless you are part of this kind of next-generation
follow-through, it is harder to get those, you cannot actually
get them in rural communities, Tribal communities, based on
your location, even though they are FDA-approved.
Secretary Becerra. Yes. We look forward to working with you
on that subject.
Senator Barrasso. Then I wanted to get to rural health
clinics. There are about 5,200 Centers for Medicare and
Medicaid Services certified rural health clinics. They provide
outpatient services all across the country. The Census Bureau
no longer defines urbanized areas--it was previously defined as
urban areas of 50,000 or more. They have kind of changed that.
But the rural health clinic statute requires that the rural
health clinics must be located in areas that are not in
urbanized areas, as defined by the Census Bureau. So they do
not define them anymore, so there is kind of a lack of policy.
So what we are seeing is that rural health clinic applications
are currently being either inappropriately rejected, based on
assumptions of what the new policy is, or blocked by States
waiting for some clarification from CMS. I know you are aware
of this. Could you just hold forth on that for a bit?
Secretary Becerra. Yes. Thanks for pointing that out. CMS
is in the process of trying to provide some guidance to clarify
that. But Senator, I will say this. If there is a particular
facility, clinic that believes it was denied access to funding
and so forth as a result of what the Census Bureau did, please
have them contact us.
Senator Barrasso. We will do that. Thank you, Mr.
Secretary.
Thank you, Mr. Chairman.
The Chairman. Before he leaves, I just want to thank my
neighbor. Those are important points with respect to rural
care, and I am not aware of these for-profit hospice issues the
way my colleague talked about them. So I would like to know
more about those as well.
Senator Barrasso. Well, thank you. Thanks so much, Mr.
Chairman.
The Chairman. I thank my friend.
All right, let's see. I believe we have a couple of other
Senators on their way. Senator Cantwell; no?
Mr. Secretary, you have been very patient. We really
appreciate that. What we wanted to do when we set out 3 hours
ago, before your infinite patience, is to show that working
families and the middle class can get ahead in this hugely
important area.
I have always felt, since my days when I was director of
the Gray Panthers, if you and your loved ones do not have your
health, everything else goes by the board. It is the most
important issue--the most important issue. What we have set out
to do here is to show that we can help working families and
seniors and the middle class get ahead. And making sure we
reduce the deficit--those two things are not mutually
exclusive. We can do both, and we certainly showed that with
respect to prescription drug cost containment.
I have one other question for you, and it is as much a
statement as anything else. We have seen the great bipartisan
interest in this committee over the last 3 hours for advocacy
for Alzheimer's patients, and it is just so urgent.
I just want you to pass on to the Department--we work often
with CMS Administrator Chiquita Brooks-LaSure, and if you will
just convey that I will be calling her very shortly to talk
about how--given what we have heard today about Alzheimer's--
she can lead this effort to speed up access for Alzheimer's
treatments and services. I think that that is----
[Applause.]
The Chairman. As a general rule, we are not supposed to
advocate clapping, and so I probably have a conflict of
interest here, so go figure. But I think, Mr. Secretary,
seriously, we have seen how strongly the committee feels. We
have seen how strongly the country feels. This is urgent,
urgent business. Please, as I say, let the Administrator, Ms.
Brooks-LaSure, who is juggling a lot of stuff and juggling it
very well, know I will be calling her about speeding up access.
Thank you. We will be working with you often in the days
ahead, and I thank you for your patience this morning and your
professionalism.
And with that, the Committee on Finance is adjourned.
[Whereupon, at 12:48 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
Chair Wyden, Ranking Member Crapo, and members of the committee,
thank you for the opportunity to discuss the President's Fiscal Year
(FY) 2024 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.
It is my great pleasure to serve as the head of the Department of
Health and Human Services--a department full of dedicated civil
servants who work tirelessly to meet our mission of enhancing the
health and well-being of the American people. We know this goal is also
shared by all of you, and we are excited about working with you to fund
key initiatives that will enable us to continue to meet that mission.
The FY 2024 budget proposes $144 billion dollars in discretionary
funding and $1.7 trillion dollars in mandatory funding to continue the
work of the Department and make major investments in several critical
areas. Our country faces numerous health-care challenges--and HHS is at
the center of addressing many of these issues--including the need to
transform behavioral health care; prepare for future public health
threats; support unaccompanied children and refugees; protect the
health of all Americans; meet the health needs of Indian Country;
expand the health-care workforce; expand coverage and access to care,
including high-quality early childhood education; improve the health
and well-being of children, families, seniors, and people with
disabilities; advance science to improve health; end cancer as we know
it; and promote effective and efficient management and stewardship.
transforming behavioral health care
In response to the current behavioral health crisis, HHS makes
substantial investments in services to provide more Americans with
access to the care they need when they need it. The 988 National
Suicide Prevention Lifeline operates 24/7 to provide access to trained
counselors to people in crisis. In the FY 2024 budget, the Substance
Abuse and Mental Health Services Administration (SAMHSA) will dedicate
an additional $334 million to the 988 program to meet an expected
volume of 9 million contacts. Investing in the crisis response
continuum more broadly is critical to ensuring that the system is
responsive at any time and in any place. The budget builds on previous
investments to provide $100 million for mobile crisis response to
expand partnerships with 988 local crisis centers, community providers,
911 centers, and first responders to promote health-first responses to
mental health, suicidal, and substance use crisis events.
One in 4 adults in the United States had a mental illness and 46
million Americans had a substance use disorder in the past year.\1\ To
address these challenges, the budget continues to invest in the
Nation's mental health infrastructure and to further integrate
behavioral health care into health care, social services, and early
childhood systems. The FY 2024 budget proposes to increase the
Community Mental Health Services Block Grant by $645 million and
proposes to increase the Substance Use Prevention, Treatment, and
Recovery Services Block Grant by $700 million. The budget converts the
Certified Community Behavioral Health Clinics demonstration to a
permanent program to further ensure access to comprehensive behavioral
health care for all who need it.
---------------------------------------------------------------------------
\1\ ``Facts about Suicide,'' Centers for Disease Control and
Prevention, https://www.cdc.gov/suicide/facts/index.html.
Additionally, to help build the behavioral health workforce needed
to provide such care and services, the FY 2024 budget expands Medicare
coverage of, and payment for, additional behavioral health professional
services including those furnished by clinical social workers, peer
---------------------------------------------------------------------------
support workers, and certified addiction counselors.
To develop new approaches to addressing mental health and substance
use disorders, the FY 2024 budget includes an additional $200 million
for the National Institutes of Health (NIH) to prioritize innovative
mental health research and treatment, with the agency allocating a
portion of these resources to launch a new precision psychiatric
initiative. NIH will also continue to invest over $1.8 billion in
research on opioid misuse, addiction, and pain disorders, including the
Helping to End Addiction Long-term (HEAL) initiative. HEAL aims to
develop innovative treatments for opioid addiction and chronic pain and
associated health disparities. The budget also includes proposals to
modernize and expand Medicare's mental health benefits and improve
behavioral health for the private insurance market, with an emphasis on
improving access, promoting equity, and fostering innovation.
preparing for future public health threats
On February 11th, HHS renewed the COVID-19 Public Health Emergency
(PHE) for what we expect will be the final time. The Nation has made
tremendous progress: the administration effectively implemented the
largest adult vaccination program in U.S. history, with nearly 270
million Americans receiving at least one shot of the COVID-19 vaccine.
Second, we made available to the American public 1.16 billion COVID
tests at no cost. And we were able to provide over 23 million
therapeutic courses of treatment to Americans. According to the
Commonwealth Fund, 2 years of COVID vaccinations saved over 3 million
lives, in addition to preventing more than 18.5 million
hospitalizations.
The FY 2024 budget prioritizes preparedness for the next health
crisis. The budget includes $20 billion in mandatory funding, available
over 5 years, across the Administration for Strategic Preparedness and
Response (ASPR), the Centers for Disease Control and Prevention (CDC),
the Food and Drug Administration (FDA), and NIH to support the
President's plan to transform the Nation's capabilities to prepare for,
and respond rapidly and effectively to, future pandemics and other
biological threats. This includes investments in enhancing early
detection and warning systems, advancing, and securing safe and
effective supplies and medical countermeasures, and strengthening
public health systems and core capabilities. For ASPR, the budget
includes $1 billion in discretionary funding for the Biomedical
Advanced Research and Development Authority (BARDA) to develop
innovative medical countermeasures, $995 million for the Strategic
National Stockpile, and $400 million to bolster the medical supply
chain and create medical countermeasures that address key preparedness
gaps. The FY 2024 budget includes $10.5 billion in discretionary
funding for the CDC to protect health, safety, and security at home and
abroad. Additional strategic investments, including at the FDA and NIH,
are proposed to bolster our national preparedness posture as we ready
ourselves for the next public health threat--no matter its origin.
These funding proposals are paired with a suite of legislative
proposals that would provide HHS with authorities to enable HHS to
respond to future threats nimbly and effectively.
supporting unaccompanied children and refugees
Children presenting at the border without a parent or guardian, and
refugees arriving in our Nation, must be cared for in a safe and
humanitarian manner. At HHS, we will continue to do our part to protect
the safety and well-being of unaccompanied children by providing them
appropriate child-centered care while they are in our custody; placing
them in the custody of parents, relatives, and other appropriate
sponsors after thorough vetting; and providing post-release services
including safety and well-being calls. HHS already provides post-
release services to more than 40 percent of children released from our
care, nearly double the percentage receiving services when the Biden
administration took office, and is on track to provide services to
nearly 60 percent of children by the end of this fiscal year, and all
children within the next 2 years.
The FY 2024 budget provides $5.5 billion for unaccompanied children
and $1.7 billion for refugees and other new arrivals eligible for
benefits. In addition, to address the inherent uncertainties in
budgeting for these populations, the budget includes a discretionary
contingency fund, which would provide additional resources if either
population exceeded certain levels and is estimated to provide $2.8
billion in FY 2024. The fund expands on the unaccompanied children
contingency fund that Congress enacted in FY 2023. These services and
resources are critical to our country, and I would like to thank
Congress for your continued dedicated support.
protecting the health of all americans
The administration aims to reduce maternal mortality and morbidity,
through proposals such as the ``Birthing-Friendly'' hospital
designation, which drives improvements in maternal health outcomes. The
budget includes $1.9 billion for the Health Resources and Services
Administration (HRSA) Maternal and Child Health programs, an increase
of $205 million, directing $276 million toward reducing maternal
mortality and morbidity and $185 million to the Healthy Start program
to reduce racial disparities in maternal and infant health outcomes.
The budget also provides $30 million for NIH to continue the
Implementing a Maternal Health and Pregnancy Outcomes Vision for
Everyone (IMPROVE) initiative to support research focused on
interventions for preventable maternal mortality and morbidity and
associated risk factors that contribute to health disparities in
maternal care. The budget further includes $3 million for NIH's
continued research on the effects of COVID-19 on individuals during
pregnancy, lactation, and the postpartum period. The budget also
requires states to provide 12 months of postpartum coverage through
Medicaid and the Children's Health Insurance Program.
HHS is also committed to protecting and strengthening access to
reproductive health care. The budget provides $512 million to the title
X family planning program to address the increased need for family
planning services for approximately 4.5 million individuals, with 90
percent having family incomes at or below 250 percent of the Federal
poverty level. Title X is the only Federal grant program solely
dedicated to providing individuals with comprehensive family planning
and related preventive health services in communities across the United
States.
In 2022, HHS released the Viral Hepatitis National Strategic Plan,
which provides a framework to eliminate viral hepatitis as a public
health threat in the United States by 2030. The Viral Hepatitis Plan
focuses on hepatitis A, hepatitis B, and hepatitis C--the three most
common hepatitis viruses that have the most impact on the health of the
Nation. The Viral Hepatitis National Strategic Plan is the first to aim
for elimination of viral hepatitis as a public health threat in the
United States. Building on this work, the FY 2024 budget includes $11.3
billion for a new HHS-wide proposal to establish a 5-year national
program to significantly expand screening, testing, treatment,
prevention, and monitoring for hepatitis C infections. This program
would increase access to tests and curative medicines and expand public
health efforts, with a net cost of $5.1 billion over 10 years once
accounting for health improvements and reduced health-care spending.
Continuing this work is vital to protecting and improving the lives of
Americans who are impacted by this serious disease.
Health Centers provide health-care services to underserved
populations across the country, including low-income patients, ethnic
minorities, rural communities, and persons experiencing homelessness.
The budget proposes a pathway to doubling the program's funding with a
critical 3-year down payment on this goal. The FY 2024 budget provides
$7.1 billion for Health Centers, which includes $5.2 billion in
proposed mandatory resources, an increase of $1.3 billion above FY 2023
enacted. At this funding level, the Health Center Program will provide
care for approximately 33.5 million patients.
The FY 2024 budget also makes critical investments to establish
Vaccines for Adults program within CDC, as a complement to the
successful Vaccines for Children program. The Vaccines for Adults
program will begin expanding access to routine and outbreak response
vaccines recommended by the Advisory Committee on Immunization
Practices for uninsured adults at no cost.
meeting the health needs of indian country
HHS is committed to upholding the United States' responsibility to
Tribal nations by addressing the historic underfunding of the Indian
Health Service (IHS). Building on the historic passage of advance
appropriations for the IHS in FY 2023, the FY 2024 budget proposes $8.1
billion in discretionary funding for the IHS Services and Facilities
accounts, an increase of $2.2 billion above FY 2023 enacted. This
funding will expand access to healthcare services for 2.8 million
American Indians and Alaska Natives, address key operational capacity
needs, and modernize outdated facilities and information technology
systems. The budget also includes $1.6 billion in proposed mandatory
funding in FY 2024 for Contract Support Costs, payments for section
105(l) Tribal leases, and the Special Diabetes Program for Indians.
Beginning in FY 2025, the budget proposes all IHS resources as
mandatory. The budget would automatically grow IHS funding each year to
account for inflationary factors, population growth, key programmatic
needs, and existing backlogs in both health-care services and
infrastructure needs. The mandatory funding approach would ensure that
the IHS budget grows sufficiently to both address historic
underinvestment and expand capacity for increased service provision. It
also includes new funding streams to address key gaps, including the
lack of dedicated funding for public health infrastructure in Indian
Country. HHS firmly believes that mandatory funding is the most
appropriate long-term solution to address chronic underinvestment in
IHS. The Department will continue consultation with Tribes and working
in partnership with Congress to see this important goal realized. While
this work is underway, it is critical that Congress continues to
provide discretionary advance appropriations to ensure that the
critical advancements achieved through enactment of advance
appropriations in the FY 2023 Omnibus are not reversed.
expanding and retaining the health workforce
The health workforce plays a vital role in responding to public
health needs. As the demand for health-care workers increases, HHS
remains committed to strengthening, expanding, and retaining the
workforce. The FY 2024 budget provides $2.7 billion for HRSA workforce
programs, including $947 million in mandatory resources, to expand
workforce capacity across the country. The discretionary budget
includes $28 million for a new program to support innovative approaches
to address health-care workforce shortages and strengthen retention
efforts. The budget also provides $25 million for a program to support
the adoption of workplace wellness in health-care facilities including
hospitals, rural health clinics, community health centers, and medical
professional associations. The budget includes $106 million within CDC
to support public health training and fellowship programs to strengthen
the existing workforce as well as support a pipeline of personnel ready
and able to address public health threats. In addition to these
investments, HHS prioritizes the importance of diversifying the health-
care workforce to better serve all communities and build a more
equitable health-care system.
expanding coverage and access to care
It is ever more crucial to promote the health, safety, and dignity
of older adults and people with disabilities, particularly as America's
older population increases. The FY 2024 budget makes essential
investments to strengthen our Nation's long-term care system and
invests $150 billion over 10 years to improve Medicaid home and
community-based services, to ensure that more people who are aging and
those with disabilities can receive care in their home or community and
to strengthen the home care workforce. President Biden also issued a
call to action to improve the quality of America's nursing homes, and
HHS continues to take action to ensure that older adult nursing home
residents receive the highest quality care. The FY 2024 budget includes
multiple provisions to strengthen nursing home oversight, transparency,
and enforcement, including $566 million for surveying and inspections.
The provisions protect older adult residents by identifying and
penalizing nursing homes that commit fraud, endanger patient safety,
and/or prescribe unnecessary drugs.
Since the passage and subsequent expansions of the Affordable Care
Act, tens of millions of Americans have gained access to quality health
insurance through the marketplace. To build on this success, the FY
2024 budget invests in making private insurance even more affordable.
This includes new proposals to build on historic progress made in
Congress, including a permanent extension of the enhanced premium tax
credits in Pub. L. 117-169, commonly known as the Inflation Reduction
Act. The budget proposes to extend protections from the No Surprises
Act to ground ambulances. The FY 2024 budget also provides Medicaid-
like coverage to low-income individuals in States that have not
expanded Medicaid under the Affordable Care Act, paired with financial
incentives to ensure states maintain their existing expansions.
improving the well-being of children, families,
seniors, and people with disabilities
Early childhood programs have a return of up to $9 for every $1
spent due to the positive long-term health, educational, and social
impacts on vulnerable children. The budget includes $13 billion for
Head Start, an increase of $1.1 billion, to provide comprehensive early
learning and development services to roughly 760,156 slots for eligible
children and pregnant women. Within this total, $440 million is
included for a cost-of-living adjustment for Head Start workers, and
$575 million is included to further improve compensation. Collectively,
these investments ensure that families have access to high-quality
services by retaining and supporting the workforce. In addition, the
budget includes a legislative proposal to expand tribal, migrant, and
seasonal Head Start eligibility.
The budget likewise invests in child care, critical to both working
parents, and particularly to mothers and children. For the
discretionary Child Care and Development Block Grant, the budget
provides for an investment of $9 billion, an increase of nearly $1
billion over the FY 2023 enacted funding level. In addition, the budget
includes a mandatory proposal to invest $400 billion over 10 years in
high-quality child care, and $200 billion over 10 years in universal
preschool.
The $400 billion in mandatory funding over 10 years for high-
quality child care includes funding for States to serve children ages
zero to five for families earning up to $200,000. It provides higher
Federal matching funds for child care providers serving low- and
middle-income families and allows those families to pay the lowest
copays--with a goal of ensuring that the lowest income families pay
nothing and that most families pay no more than $10 a day per child,
meaning that a median-income family with young children saves about
$400 per month while accessing higher-quality care. The
administration's proposal enables States to expand access to
affordable, high-quality child care to more than 16 million children.
This reflects an expectation that all States will choose to adopt the
program but, if some States do not, the administration is committed to
serving low-income children through a Federal alternative.
The $200 billion in mandatory funding over 10 years for universal
preschool supports free preschool in the setting of a parent's choice--
from public schools to child care providers to Head Start--to support
healthy child development and ensure that children enter kindergarten
ready to succeed. The proposal provides funding through a Federal-State
partnership to expand high-quality preschool education to all 4-year-
old children, with the flexibility for States to expand preschool to 3-
year-olds once high-quality preschool is fully available to 4-year-old
children. The proposal also includes funding to provide access to
preschool to children in underserved communities in States that do not
choose to participate in the new preschool program, so that families in
every State have access to high-quality preschool.
To further protect and enhance child well-being, the budget also
includes $4.9 billion in mandatory funding over 10 years for prevention
services and kinship navigator programs, $1.3 billion in mandatory
funding over 10 years to give States an incentive to place children
with kin, and $1 billion in mandatory funding over 10 years for support
for youth who experienced foster care in transitioning to adulthood.
The COVID-19 pandemic revealed that millions of children, families,
seniors, and people with disabilities are living with food insecurity.
The increased need for nutrition programs has not abated, and the FY
2024 budget supports the administration's National Strategy on Hunger,
Nutrition, and Health by including $137 million across HHS to reduce
hunger, food insecurity, and malnutrition. Within the $137 million, the
budget includes $12 million at the Administration for Community Living
(ACL) for nutrition services for older adults and people with
disabilities and $72 million to expand CDC's State Physical Activity
and Nutrition program, which implements evidence-based strategies to
reduce chronic disease. In addition, the budget proposes to increase
funding at NIH for nutrition research. The budget also expands Medicare
coverage for nutrition and obesity counseling, and includes a new pilot
project on medically tailored meals.
HHS is committed to ensuring that seniors and people with
disabilities have the essential resources and services they need. The
FY 2024 budget also makes key investments in the Elder Justice Adult
Protective Services program. And, to help more older adults and those
with disabilities receive care in their home or community. As noted
above, the budget also includes a $150 billion mandatory investment
over 10 years in improving and strengthening Medicaid home and
community-based services and provisions to improve safety and quality
in our Nation's nursing homes.
The budget extends the solvency of the Medicare hospital insurance
trust fund by at least 25 years without cutting benefits. The budget
builds on efforts in the Inflation Reduction Act to lower prescription
drug prices. It also invests $8 billion to enhance Medicare benefits,
such as preventing diabetes, expanding access to behavioral health
services and community health workers, improving the quality and safety
of long-term care services, expanding coverage for nutrition and
obesity counseling, eliminating hepatitis C, and advancing equity.
Additionally, the budget aligns income and asset determination
processes for Medicare low-income assistance programs, easing
administrative burdens for States and removing enrollment barriers for
individuals.
advancing science to improve health
As President Biden has said, ``cancer does not care if you're a
Republican or a Democrat,'' which is why the President and First Lady
reignited the Cancer Moonshot 1 year ago. HHS is committed to leading
the public sector in pursuit of cutting the cancer death rate by 50
percent over the next 25 years and supporting families, their
caregivers and family members, living with and surviving cancer.
NIH will continue to build on the Cancer Moonshot's momentum by
supporting projects that will deliver important insights into
preventing, detecting, and treating cancer. The FY 2024 budget includes
$716 million in discretionary resources for dedicated Cancer Moonshot
activities at NIH. In addition to the FY 2024 resources, the budget
also proposes to reauthorize the 21st Century Cures Act Cancer Moonshot
through 2026 and provide $2.9 billion in mandatory funding in 2025 and
2026, $1.45 billion each year. To support the goals of the Cancer
Moonshot, the FY 2024 budget includes an additional $183 million for a
total of $839 million to support cancer prevention and control programs
across CDC, including screening programs, tobacco prevention, Human
Papillomavirus (HPV) prevention and analysis of cancer clusters, and
laboratory and environmental health activities. An additional
investment of $20 million for HRSA is also provided, to expand
partnerships between federally funded health centers and NCI-Designated
Cancer Centers to facilitate access to lifesaving cancer screenings and
early detection services for medically underserved populations. The
budget also includes $108 million within IHS to address specialized
cancer care needs in tribal communities. The budget also proposes to
create a new Cancer Care Quality Reporting Program for all Medicare
providers furnishing cancer care services. This unified program would
enable the Centers for Medicare and Medicaid Services (CMS) to assess
and compare cancer care delivered through multiple provider types,
drive improvements in the quality of cancer care, and standardize data
collection to identify and address potential inequities in care.
The FY 2024 budget includes several investments for FDA to support
food programs including $20 million for the Emerging Chemicals and
Toxicology Issues program to streamline regulatory frameworks for food
products that may pose chronic risks to human health. Funds support
post-market reassessment of previously approved food chemicals and
develop approaches to inform and modernize safety assessments using
science and risk-based approaches. An additional investment of $5
million is provided for the 21 Forward food supply chain continuity
system, which enables the agency to develop accurate models for
situational awareness and forecast the impact of a pandemic, product
shortages, or other high-risk threats on the food supply chain. Within
medical product safety, the budget dedicates a total of $59 million to
continue efforts that strengthen public health supply chains and
promote the availability of medical devices by proactively monitoring,
assessing, and communicating risks and vulnerability.
The budget will prioritize innovative mental health research and
treatment and the NIH climate change initiative. NIH will continue to
invest funds to address the opioid crisis, end HIV, and advance other
research areas, such as improving health disparities and inequities
research, as well as continuing the agency's progress towards a
universal influenza vaccine. NIH's budget also continues support for
the All of Us and Brain Research Through Advancing Innovative
Neurotechnologies (BRAIN) initiatives, both started with the 21st
Century Cures Act.
The budget also invests in high-impact research advances that drive
innovation through the Advanced Research Projects Agency for Health
(ARPA-H). As an independent research entity, ARPA-H will be able to
accelerate health breakthroughs with the potential to transform
important areas of health and medicine. The budget provides $2.5
billion for the agency's approach to prevent, detect, and treat cancer
and other diseases such as diabetes and dementia. ARPA-H will advance
high-
potential, high-impact biomedical and health research that cannot be
readily accomplished through and other existing research or commercial
activity.
In keeping with the Agency for Healthcare Research and Quality's
(AHRQ) mission to provide evidence-based research, data, and tools to
improve health-care quality, the FY 2024 budget includes $564 million
to support AHRQ's research on quality, health costs, and outcomes to
make health care safer, more accessible, equitable, and affordable for
all Americans. Included are additional resources to further Long COVID
care, primary care, and diagnostic safety research.
promoting effective and efficient management and stewardship
As Federal stewards, it is our duty to ensure that taxpayer dollars
are spent appropriately through the delivery of high-quality services,
through necessary security, and through strong action to prevent fraud
and abuse. To protect against information technology threats, the
budget provides an increase of $88 million above FY 2023 enacted for
cybersecurity initiatives in the Office of the Chief Information
Officer (OCIO). Due to the increasing frequency of cyber-attacks that
impede the delivery of health care and leak private patient health
information, the ASPR and OCIO budgets have been increased to
understand, mitigate, and identify Health-care and Public Health (HPH)
Sector cybersecurity risks, as well as, to prevent, detect, respond,
and recover from HPH cyber-attacks.
The budget makes robust investments in the Health Care Fraud and
Abuse Control funding to provide oversight of CMS health programs,
strengthen the HHS Office of Inspector General investigations, and
protect beneficiaries against health-care fraud. Our comprehensive
program integrity legislative package and allocation adjustment yields
$19.7 billion in net savings over 10 years. The Office of Civil Rights
would receive significant additional funding to address a sharp rise in
its caseload, from 45,000 cases in 2020 to a projected 80,000 in 2024.
Finally, the budget includes much-needed investment in core
infrastructure, oversight, and operations, including in the
Nonrecurring Expenses Fund, General Departmental Management, CMS
Program Management, and ACL.
conclusion
I want to thank the committee for inviting me to discuss the
President's FY 2024 budget for HHS. The budget represents the continued
investment in the health, growth, protection, and vitality of the
American people. With adequate funding in these critical areas, we can
support the forward mobility of our country and continue to make stride
towards a brighter future. Thank you for your dedication and
partnership in 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
hospital price transparency
Question. On January 1, 2021, Federal Hospital Price Transparency
regulations went into effect. Federal hospital price transparency rules
require each hospital to make public the standard charges for items and
services they provide. Hospitals are required to make standard charges
public through a consumer-friendly display consisting of at least 300
shoppable services and a comprehensive, machine readable file. During
the second year of hospital price transparency rules, CMS reviewed 600
randomly selected hospitals, and 70 percent of hospitals met the
requirements. As of January 2023, CMS sent nearly 500 warning notices
and 230 requests for corrective action plans. Nearly 300 hospitals
addressed noncompliance. CMS issued civil monetary penalties against
only two hospitals for failure to come into compliance. It is critical
for CMS to ensure compliance with hospital price transparency rules to
help patients shop for information, to provide researchers information
to analyze variation in charges, and to help employers negotiate more
competitive rates.
Which metrics does CMS use to define compliance with Federal
hospital price transparency requirements? Does this account for
differences between CMS's assessment of compliance and studies
conducted by third parties?
How does CMS define a shoppable service?
What are some of the challenges accessing data that are not
publicly available to determine compliance?
What is CMS's timing for requiring compliance with a standardized
hospital price transparency template?
Will CMS post publicly information about hospitals that are issued
a written warning notice and have to complete a corrective action plan
to come into compliance with hospital transparency rules?
Does CMS have plans to provide a more detailed compliance analysis
to capture more hospitals? Would this require additional funding from
Congress?
Answer. Enforcing the hospital price transparency requirements is a
high priority for CMS in order to increase competition and bring down
costs. It is imperative that consumers can access cost information to
shop for care and save money and for employers to use data to negotiate
more competitive rates. After significant outreach and technical
assistance to hospitals, hospitals have made substantial progress since
January 2021.
Compliance Analyses
CMS's Hospital Price Transparency compliance analyses focus on
aspects of the regulation that can be unambiguously determined by
looking at the data posted by the hospital on its website. CMS's
analysis aligns closely with many other external assessments. CMS
evaluates according to the regulatory requirements. For example, the
fact that there is no specific negotiated charge associated with a
particular service--e.g., deep brain stimulation, a commonly performed
surgical treatment for Parkinson's disease--may mean that the hospital
has not in fact established a negotiated rate for that procedure
because it just does not offer that type of neurosurgery, or it may
signal the omission of required information and indicate noncompliance.
That type of information--whether or not the hospital is actually
offering the service--is the type of information that is gleaned during
the comprehensive compliance review in the back and forth between a
hospital and CMS.
CMS's compliance assessments thus far were done primarily to
understand and quantify the general state of hospital compliance, in
support of our policy and enforcement activities. Beyond the initial
proactive assessment (done in early January 2021), CMS has been
systematically working through the high volume of complaints submitted
by the public through the website. As of January, 2023, CMS has issued
nearly 500 warning notices and over 230 requests for corrective action
plans. 300 hospitals have addressed problems and have become compliant
with the regulations, leading to closure of their cases, including the
2 hospitals which we have issued civil monetary penalties.
Shoppable Service
The Hospital Price Transparency regulations define a shoppable
service as ``a service that can be scheduled by a health-care consumer
in advance.''\1\
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\1\ 45 CFR part 180--Hospital Price Transparency, https://
www.ecfr.gov/current/title-45/subtitle-A/subchapter-E/part-180.
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Standardized Data
CMS continues to work to improve the collection and display of
standardized data, including by holding a listening session to discuss
ways to display information for consumers, and by encouraging hospitals
to format and validate their data sets. In an effort to assist
hospitals in complying with the requirements under the Hospital Price
Transparency regulations and also providing consistency in how those
disclosures are viewed by consumers, CMS has made available several
sample formats using a standardized set of data elements that hospitals
may use to make public their standard charges. CMS also has finalized a
requirement that the machine-readable file be accessible to automated
searches and direct downloads. Further, CMS has clarified that the
estimate from a price estimator tool, voluntarily used by the hospital
in lieu of making public a consumer-friendly list of standard charges,
must be tailored to individuals' circumstances and represent a real-
time individualized out-of-pocket estimate of the amount they would
have to pay the hospital that takes into account any applicable benefit
information.
Enforcement
In CMS's enforcement of the hospital price transparency rules, the
agency's goal is to increase access to useful, meaningful information
for consumers and ensure hospitals are following through on their
obligations to make information available. CMS is working closely with
hospitals to bring them into compliance, and the agency in the process
of examining further improvements to the program, including ways that
CMS enforcement could be used to increase compliance.
digital therapeutics
Question. The President's FY 2024 budget includes a legislative
proposal to establish Medicare coverage of evidence-based digital
applications and platforms that facilitate the delivery of mental
health services, especially for beneficiaries who live in rural or
health professional shortage areas. As the Senate Committee on Finance
continues to advance legislation to address barriers to mental health
care and use innovative tools to address mental health workforce
shortages, it will be important to gain additional detail on this
proposal.
Is it possible for Medicare to establish coverage for these digital
applications and platforms (hereinafter ``apps'') via existing national
or local coverage determination processes?
Would this FY 2024 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?
In CMS's view, how have innovations without defined benefit
categories made their way into the standard reimbursement structure?
Answer. Thank you for your interest in expanding access to digital
technologies in Medicare. As you noted, President Biden's Fiscal Year
2024 budget includes a proposal that would allow for Medicare coverage
of evidence-based digital applications and platforms that facilitate
greater access to behavioral health services, especially for
beneficiaries who live in rural or health professional shortage
areas.\2\ If you are interested in drafting legislation to address
Medicare's coverage of digital technologies, CMS would be happy to
provide technical assistance.
---------------------------------------------------------------------------
\2\ FY 2024 HHS Budget in Brief, https://www.hhs.gov/sites/default/
files/fy-2024-budget-in-brief.pdf.
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adoption and foster care analysis and reporting system (afcars)
Question. The President's budget does not include proposals to
improve the Adoption and Foster Care Analysis and Reporting System
(AFCARS) to address longstanding concerns about the over-representation
and lack of equitable treatment of LGBTQ+ and Native American children
and youth in the child welfare system. As you know, AFCARS requires
reporting on key metrics with the goal of understanding trends in child
welfare and improving outcomes for children and youth.
Will the Children's Bureau be promulgating a rule to address gaps
in data collection concerning LGBTQ+ and Native American children and
youth to capture existing disparities in the child welfare system and
improve outcomes for children in foster care?
If so, when can we expect to see a Notice of Proposed Rulemaking?
Answer. The Fall 2022 Unified Agenda lists an AFCARS NPRM.\3\ HHS
is committed to the equitable treatment of all youth in the child
welfare system and to address longstanding disparities particularly for
LGBTQI+ and Native American youth. We expect that the Unified Agenda
for the Spring of 2023 will again include an AFCARS NPRM.
---------------------------------------------------------------------------
\3\ https://www.reginfo.gov/public/do/
eAgendaViewRule?pubId=202210&RIN=0970-AC98.
______
Questions Submitted by Hon. Ron Wyden and Hon. Robert P. Casey, Jr.
nursing home emergency preparedness
Question. On February 23 2023, Chairman Wyden, along with Chairman
Casey of the Senate Special Committee on Aging, issued a report
(https://www.finance.
senate.gov/chairmans-news/wyden-casey-examine-long-term-care-
shortfalls-during-texas-winter-blackout) titled, ``Left in the Dark,''
which examined the impacts of the 2021 Texas blackout on nursing homes
and the need for robust emergency preparedness in long-term care
facilities. This report tells the story of the older adults and people
with disabilities living in long-term care facilities, including
skilled nursing facilities or nursing facilities participating in the
Medicare and/or Medicaid programs, who were affected by the 2021 Texas
winter storm and subsequent blackout. The report also shines a light on
other disasters that have affected nursing homes in more than a dozen
States since 2018, including our home States of Oregon and
Pennsylvania. Lastly, the report also highlights troubling findings by
the Inspector General for the Department of Health and Human Services,
which identified serious emergency preparedness shortfalls at nursing
homes in eight States. This work built on Chairman Wyden's 2018 report
(https://www.finance.senate.gov/ranking-
members-news/wyden-finds-nursing-homes-unprepared-for-natural-
disasters), ``Sheltering in Danger,'' that examined the impacts that
Hurricanes Harvey and Irma had on nursing homes in Texas and Florida,
respectively.
The report issued eight new recommendations for Federal, State and
local governments to improve emergency preparedness in long-term care
facilities. The findings and recommendations of this report are
critical as the number of disasters and extreme weather events
affecting our Nation increases, a trend scientists attribute to climate
change. We ask that HHS detail how it plans to address and carry out
each of the recommendations the report directs to it, which are listed
below for convenience.
A. Improve Inclusivity of Disaster Planning, Preparedness and
Management in Communities: CMS, the Department of Homeland
Security, States and local governments should ensure that older
adults, people with disabilities and residents of long-term
care facilities are substantially involved in emergency
planning, response, mitigation, management, and recovery.
Congress should pass the Real Emergency Access for Aging and
Disability Inclusion (REAADI) for Disasters Act, which would
ensure that people with disabilities and older adults have a
voice at every stage of disaster management through
representation on emergency preparedness planning councils and
boards; require accessible information about planning for
disasters; and make sure that shelters and temporary housing
are accessible to older adults and people with cognitive,
sensory, and physical disabilities. In addition, States and
local governments should seek to include older adults and
people with disabilities as members of emergency preparedness
oversight committees and advisory panels.
B. Improve Staffing--Nursing Homes: CMS should promulgate
mandatory minimum staffing standards for Skilled Nursing
Facilities and Nursing Facilities following completion of its
study to determine the level of staffing necessary to ensure
safe and high-quality care. Congress should pass provisions in
the Nursing Home Improvement and Accountability Act of 2021
targeted at improving staffing, such as providing additional
Federal resources through Medicaid to increase wages and
improve recruitment and retention of staff. Research has
repeatedly linked low staffing levels in nursing homes to poor
quality care and patient safety violations. Increasing staff
levels and reducing staff turnover would better equip nursing
homes to respond to emergencies.
C. Increase the Transparency of Emergency Plans: CMS should
evaluate the feasibility of requiring nursing homes to provide
residents and their families with copies of the facility's
emergency preparedness plan during intake, and once annually
after the facility has completed the federally required update
of its emergency plan. CMS should also evaluate the feasibility
of posting emergency plans on Care Compare to make them easily
accessible for people considering nursing homes for themselves
or their loved ones.
D. Incorporate Climate Change Risks Into Emergency
Preparedness: CMS should evaluate the feasibility of requiring
nursing homes to incorporate climate change risks, such as the
increasing incidence of extreme weather events, into emergency
preparedness planning. If deemed feasible, CMS should issue
regulations and guidance that directs nursing homes to consider
the effects of climate change into their all-hazards
assessment. Such requirements would be in line with findings
from the most recent National Climate Assessment, which was
mandated by Congress in 1990. The climate assessment notes that
``over decades or longer, emergency preparedness and disaster
risk reduction planning can benefit from incorporating climate
projections to ensure communities are prepared for changing
weather patterns.''
E. Incorporate Renewable Energy Into Emergency Preparedness:
CMS and States should ensure emergency power requirements for
nursing homes offer flexibility for facilities to use clean
energy for secondary emergency power sources, particularly as
costs of renewable energy and energy storage continue to
decline. CMS should work with the Internal Revenue Service and
Department of Energy to offer guidance that educates nursing
homes about the availability of Federal tax credits, financing
and grants that further reduce the costs of installing clean
energy resources and improving energy efficiency through
provisions in the Inflation Reduction Act, and other programs.
F. Ensure Equitable Emergency Preparedness: CMS should conduct
a study that examines the equity of emergency preparedness in
and among nursing homes. Such a study should consider factors
such as payer mix of residents, racial and ethnic makeup of
residents, the percentage of residents reliant on long-term
services and supports, geographic location, climate change
risks, and the social vulnerability index of the community
where facilities are located. CMS should use the study to
evaluate ways in which the agency and State partners can
improve emergency preparedness for people of color, people
living in poverty, and people with disabilities who live in
nursing homes.
Answer. Protecting the health and safety of nursing home residents
is highest priority of the OIG. OIG has long identified ensuring
quality of care in nursing homes as among the Department's top
management and performance challenges. While many nursing homes provide
excellent care, decades of OIG oversight and enforcement have revealed
persistent, entrenched problems in nursing homes ranging from
preventable harm to residents to failed emergency preparedness to and
gaps in available consumer information, among others. Currently, OIG
has a number of audits and evaluations underway to examine emergency
preparedness in nursing homes. Below are some examples of ongoing work:
Nursing Home Capabilities and Collaboration to Ensure
Resident Care During Emergencies (https://oig.hhs.gov/reports-
and-publications/workplan/summary/wp-summary-0000654.asp).
State Survey Agency Processes for Overseeing Nursing Home
Preparedness (https://oig.hhs.gov/reports-and-publications/
workplan/summary/wp-summary-0000764.asp).
Audit of Nursing Homes' Emergency Power Systems (https://
oig.hhs.gov/reports-and-publications/workplan/summary/wp-
summary-0000784.asp).
Medicaid Nursing Home Life Safety and Emergency Preparedness
Reviews (https://oig.hhs.gov/reports-and-publications/workplan/
summary/wp-summary-0000453.asp).
Accuracy of Nursing Home Compare Website's Reported Health,
Fire Safety, and Emergency Preparedness Deficiencies (https://
oig.hhs.gov/reports-and-publications/workplan/summary/wp-
summary-0000508.asp).
CMS appreciates Chairman Wyden's and Chairman Casey's leadership on
the critical issue of emergency preparedness in nursing homes. The
investigation by the majority staffs of the U.S. Senate Finance
Committee and the U.S. Senate Special Committee on Aging, ``Left in the
Dark: The impact of the 2021 Texas Blackout on Long-Term Care Residents
and the Need to Improve Emergency Preparedness,'' is an urgent request
for all long-term care facilities to prepare to protect their residents
in emergencies no matter the cause of the emergency. As the
investigation notes, while the timing and type of disasters cannot
always be predicted, the risks can be anticipated and prepared for
through robust assessments and plans, frequent training, and
maintenance of equipment and supplies.
Improving the inclusivity of disaster planning and preparedness to
better meet the unique needs of older adults and people with
disabilities, whether they live in the community or a long-term care
facility, is an HHS priority. Involving the aging and disability
communities in all stages of disaster planning, preparedness, response
and recovery is critical to improving the outcomes for these
populations when disasters strike.
Monitoring patient safety and quality of care in nursing homes
requires coordinated efforts between the Federal Government and the
States. Through its survey and certification efforts, CMS works in
partnership with State survey agencies to oversee nursing homes and
hold them accountable to Medicare and Medicaid Conditions of
Participation requirements to ensure safety and quality of care.
Additionally, the ACL Long-Term Care Ombudsman Program advocates for
older adults and persons with disabilities in long-term care facilities
to ensure their rights are protected and any concerns related to
health, safety, and quality of life are addressed. Ombudsmen resolve
individual complaints, while also advocating for systemic improvements.
In 2021, ombudsmen representatives worked on 164,299 resident
complaints.
Under CMS requirements, long-term care facilities are required to
develop and maintain an emergency preparedness program that includes an
emergency plan, policies and procedures, a communication plan, training
and testing programs, and emergency and standby power systems. Long-
term care facilities must establish policies and procedures that
determine, among other things, how required heating and cooling of
their facility will be maintained during an emergency situation if
there were a loss of the primary power source. CMS took significant
steps to update its emergency preparedness guidance for long-term care
facilities in 2019, and in 2021, and will use the investigation's
findings as we consider additional changes that may be needed to
protect nursing home residents during emergencies.
The committees recommend that CMS should issue mandatory minimum
staffing standards for long-term care facilities. In February 2022,
President Biden announced a comprehensive set of reforms to improve the
safety and quality of nursing home care and hold nursing homes
accountable for the care they provide. CMS has launched a multifaceted
approach aimed at determining the minimum level and type of staffing
needed to enable safe and quality care in nursing homes. CMS intends to
issue its proposal for minimum staffing requirements using the notice-
and-comment rulemaking process--providing further opportunities for all
interested parties to weigh in.
The investigation also calls on Congress to increase funding for
survey and certification activities. Annual survey and certification
budgetary funding levels have been flat since FY 2015 while 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. CMS strongly
supports this call for additional survey and certification activities.
As CMS is continually reviewing our programs for improvement, we
will consider the investigation's recommendations so that long-term
care facilities are held accountable for emergency preparation. No
facility should be caught unprepared for an emergency and residents and
workers must be adequately protected and cared for.\4\
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\4\ Language pulled from CMS reactive statement cleared by OGC.
______
Questions Submitted by Hon. Mike Crapo
On Inflation Reduction Act (IRA) Price-Setting
Program Implementation Guidance
definition of ``qualifying single-source drug'' for program purposes
Question. The definition of ``qualifying single-source drug''
included in CMS's initial guidance for the implementation of the IRA's
price-setting program risks dramatically expanding the size and scope
of new Federal initiative. Finalized under section 30 of the guidance
document, CMS has adopted a seemingly anomalous approach, departing
from standard statutory and regulatory definitions of ``drug'' and
``biologic'' to treat virtually all medications with the same active
ingredient or moiety and the same manufacturer as a single product,
regardless of clinically meaningful differences.
Based on this definition, new indications, formulations, strengths,
or other differences would prove insufficient to distinguish between
two medications with a shared active ingredient, even if approved or
licensed pursuant to a distinct New Drug Application (NDA) or Biologics
License Application (BLA). The price-setting program would capture all
forms of any medicines with the same active ingredient, with
eligibility for selection and price-setting determined based on the
first approval or licensure date for a product that includes the active
moiety (and with the same manufacturer), even if years or decades of
high-cost, high-risk, and time-intensive research and development
programs separated two different drugs or biologics.
What is the statutory basis for treating drugs or biologics with
the same active ingredient/moiety but with approvals or licensure
granted pursuant to separate NDAs or BLAs as the same product for
eligibility and selection purposes? Where else in statute or in
regulation does a Federal agency aggregate multiple different
medications in this way?
This definition seems likely to discourage research and development
into new indications, formulations, dosage forms, and strengths for any
given compound, since even the most clinically meaningful enhancements
or novel uses would afford manufacturers no avenue out of the price-
setting program. Particularly for active ingredients with earlier
initial applications, the law's declining statutory price ceilings
could make any potential financial returns from new indications,
patient populations, or improvements unfeasible. Has CMS conducted an
impact analysis of the effect of this definition on R&D into new
indications, formulations, or other developments with respect to
existing compounds?
Will CMS consider providing an opportunity for public comment with
respect to section 30 of the guidance document, given the far-reaching
implications of this definition and of other policies included in the
section?
Answer. The initial guidance details the requirements and
parameters of the Medicare Drug Price Negotiation Program, including
requests for public comment on key elements of the program, and
announces the next steps for how the agency will implement the new
program for 2026, which is the first year in which the first set of
negotiated prices will apply. In the initial guidance, CMS describes
the definition we will use to identify a qualifying single source drug
for purposes of selection and negotiation for initial price
applicability year 2026. This approach to identifying a qualifying
single source drug aligns with the requirement in the law to use data
aggregated across dosage forms and strengths of the drug, including new
formulations of the drug.
As always, CMS broadly welcomes input from the public at all times.
In the initial guidance for the Medicare Drug Price Negotiation
Program, CMS is voluntarily soliciting comment on a number of key
topics related to implementation of the new program. Due to timing
constraints and the requirement to publish the selected drug list for
initial price applicability year 2026 by September 1, 2023, CMS is
issuing guidance on topics related to drug selection as final, without
a comment solicitation.
Comments received by April 14, 2023, will be considered for revised
guidance. CMS anticipates issuing revised guidance for the first year
of negotiation in Summer 2023. CMS is striving for an effective
negotiation process with manufacturers that lowers prescription drug
prices and ensures people with Medicare have access to innovative
therapies, while meeting the ambitious timeframes specified under the
law.
implications for rare disease patients
Question. While the IRA excludes orphan drugs indicated for just
one rare disease or condition from selection for the price-setting
program, the narrowness of this exemption risks discouraging drug
developers from undertaking the high-cost and high-risk research and
development needed to identify new potential uses for products that
meet this definition, since even a new indication for a second rare
disease would render an orphan drug ineligible for the law's exemption.
Will you commit to working with Congress to remedy this exemption
by ensuring that it applies to orphan drugs with indications for
multiple different rare diseases, recognizing that the current
exclusion structure disincentivizes R&D into additional indications?
The guidance notes that CMS ``is considering whether there are
additional actions CMS can take in its implementation of the
Negotiation Program to best support orphan drug development.'' What
types of actions on this front is the agency considering, and how can
Congress support these efforts?
Answer. CMS supports continued drug innovation and believes it is
vitally important that beneficiaries have access to innovative new
therapies. We are striving to implement the Negotiation Program in a
thoughtful way that both improves drug affordability and accessibility
for people with Medicare and supports innovation.
The law requires CMS to exclude certain orphan drugs when
identifying qualifying single source drugs, referred to as the orphan
drug exclusion. To be considered for the orphan drug exclusion, the
drug or biological product must (1) be designated as a drug for only
one rare disease or condition by the FDA and (2) be approved by the FDA
only for one or more indications within such designated rare disease or
condition. As noted in the initial guidance, we are still considering
whether there are additional actions CMS can take in its implementation
of the Negotiation Program to best support orphan drug development. The
agency will continue to keep Congress and stakeholders updated as we
move forward.
the price-setting process
Question. The initial guidance affords affected manufacturers up to
three in-
person or virtual meetings over the course of the price-setting
process, which could help to facilitate and clarify the exchange of
offers and information under the program. By stipulating that the first
meeting will not occur until after the manufacturer has submitted a
counteroffer, however, the guidance document constrains early
opportunities for engagement between the agency and manufacturers.
Along the same lines, by artificially capping the number of meetings at
three, the guidance document fails to provide sufficient flexibility
and adaptability for agency officials and manufacturers.
Will CMS consider allowing for more than three in-person or virtual
meetings in the course of the negotiation process, given that
additional engagement opportunities might inform price offers and
counteroffers, in addition to clarifying potential misconceptions and
answering outstanding questions?
To that end, will CMS consider allowing for in-person or virtual
meetings earlier in the negotiation process (i.e., prior to the
counteroffer stage, and ideally prior to the initial offer issuance),
since such conversations could better inform and clarify considerations
related to the agency's initial offer determination, as well as the
manufacturer's counteroffer determination?
Answer. The law requires the Secretary to negotiate directly with
manufacturers, in an offer/counteroffer process, in order to arrive at
a maximum fair price. For initial price applicability year 2026, the
law requires that by February 1, 2024, CMS must provide the
manufacturer of a selected drug with a written initial offer and if the
manufacturer provides a counteroffer to the initial offer, such
counteroffer must be in writing. As described in the initial guidance
for 2026, if CMS's written response to the counteroffer rejects the
manufacturer's written counteroffer, CMS will extend an invitation to
the manufacturer for a negotiation meeting. After this initial meeting,
CMS intends to give each party (CMS and the manufacturer) the
opportunity to request one additional meeting, resulting in a maximum
of three meetings between CMS and the manufacturer.\5\
---------------------------------------------------------------------------
\5\ Pulled from Medicare Drug Price Negotiation Program Initial
Guidance (pp. 55-56), https://www.cms.gov/files/document/medicare-drug-
price-negotiation-program-initial-guidance.pdf.
CMS believes that the negotiation meeting process described in the
initial guidance for 2026 allows for a more efficient and effective
approach than preparing and exchanging additional written offers and
counteroffers. Negotiation meetings would also allow both parties to
discuss any new information that may have become available about the
selected drug or its therapeutic alternatives, consistent with the
negotiation factors described in the statute, that may affect the
determination of the maximum fair price. CMS believes that an offer/
counteroffer process that includes in-person or virtual meetings would
most effectively facilitate the negotiation process to arrive at a
maximum fair price and is more consistent with current industry
practices for drug price negotiation. In the initial guidance for 2026,
CMS solicited comments on this proposed drug price negotiation process,
and specifically requested comment on the advantages and disadvantages
of this negotiation process, as well as whether there are alternatives
that CMS should consider. Comments received by April 14, 2023, will be
considered for revised guidance. CMS anticipates issuing revised
guidance for the first year of negotiation in Summer 2023.\6\
---------------------------------------------------------------------------
\6\ Pulled from Medicare Drug Price Negotiation Program Initial
Guidance (pp. 55-56), https://www.cms.gov/files/document/medicare-drug-
price-negotiation-program-initial-guidance.pdf.
---------------------------------------------------------------------------
negotiation versus price-setting
Question. While the IRA characterizes the new price-setting program
as ``negotiation,'' manufacturers appear to have no meaningful choice
except to accept the final offer dictated by the Secretary, regardless
of how unrealistically low it might be. Rejecting the offer would
require a drugmaker either to incur an impossibly steep penalty of up
to 95 percent of all gross sales for a selected drug, or else to pull
all drugs from Medicare and Medicaid entirely, an unrealistic
proposition for the vast majority of manufacturers, and one with
significant access risks for patients. This dynamic minimizes
manufacturers' leverage, as the law and guidance document offer them no
apparent recourse for an unfairly and arbitrarily low price-point.
Does CMS plan to provide manufacturers with access to any dispute
resolution processes or mechanisms over the course of the price-setting
process?
What steps can the manufacturer of a selected drug take if CMS
presents a final offer with an unfairly and arbitrarily sub-market
price? What recourse do the law and associated guidance documents
provide, apart from two practical impossibilities (incurring the 95
percent penalty or pulling all drugs from major Federal programs)?
Answer. The initial guidance details the requirements and
parameters of the Medicare Drug Price Negotiation Program, including
requests for public comment on key elements of the program, for initial
price applicability year 2026. Among the key elements that CMS is
soliciting comments on is a dispute resolution process for specific
issues that are not exempt from administrative and judicial review
under the law.
The law requires the Secretary to negotiate directly with
manufacturers, in an offer/counteroffer process, in order to arrive at
a maximum fair price and consider specific factors in the negotiation
process. The government will not set these prices unilaterally. CMS is
committed to following the bilateral negotiation process specified by
the law.
As described in the initial guidance for 2026, in developing the
initial offer, CMS intends to focus on the clinical benefit that the
drug provides to people with Medicare as well as whether the drug
addresses an unmet medical need and its impact on specific populations
compared to its therapeutic alternatives. To formulate an initial
offer, CMS intends to: (1) identify therapeutic alternative(s), if any,
for the selected drug; (2) use the Part D net price for the therapeutic
alternative(s) that are Part D drugs and/or the Part B average sales
price for the therapeutic alternatives that are Part B drugs to
determine a starting point in developing an initial offer; (3) evaluate
the clinical benefit of the selected drug (including compared to its
therapeutic alternative(s)), including whether the selected drug meets
an unmet medical need and the selected drug's impact on specific
populations; and (4) further adjust the preliminary price by the
manufacturer-specific factors outlined in the law to determine the
initial offer price. CMS will not make or accept any offers for the
maximum fair price that are above the statutorily defined ceiling price
in the law.
In cases where the selected drug has no therapeutic alternative, or
if the price of the therapeutic alternatives identified is above the
statutory ceiling for the maximum fair price, CMS intends to determine
the starting price for the initial offer based on the Federal Supply
Schedule (FFS) or ``Big Four'' price.\7\ If the FSS and Big Four prices
are above the statutory ceiling, then CMS intends to use the statutory
ceiling as the starting point for the initial offer.
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\7\ The Big Four price is the maximum price that any ``Big Four
Agency'' (the Department of Veteran's Affairs (VA), Department of
Defense (DoD), the Public Health Service, and the Coast Guard) is
required to pay. See: https://www.cbo.gov/publication/57007.
CMS will be considering the negotiation factors outlined in the law
very seriously. CMS is striving to implement the Negotiation Program in
a thoughtful way that both improves drug affordability and
accessibility for people with Medicare and supports innovation.
deterring public private partnerships
Question. The guidance document for the price-setting program
specifies that the receipt of Federal financial support at any stage of
drug discovery or development will trigger a downward adjustment in the
Secretary-mandated price ceiling for a given product. This provision,
if finalized, could discourage manufacturers from partnering with the
Federal Government, thus undermining the core framework for innovation
established under the Bayh-Dole Act.
Will CMS commit to reconsidering its interpretation of the Federal
financial support factor, given the risk of deterring the types of
public-private partnerships that have driven some of our greatest
medical advances?
Answer. The Medicare Drug Price Negotiation Program is unrelated
and stands separate and apart from march-in authority. CMS is committed
to following the bilateral negotiation process specified by the law
with manufacturers of the drugs selected for negotiation.
The statute requires that CMS consider certain factors for
negotiating the maximum fair price, including certain information
provided to CMS by manufacturers, that is specific to the drug that is
subject to negotiation. Prior Federal financial support for novel
therapeutic discovery and development received by the manufacturer for
the drug is one of the factors identified in the law that CMS is
required to consider in the negotiation. We are implementing the
Negotiation Program in accordance with the law. The initial guidance
describes the consistent process CMS is proposing to use when
considering all these factors when negotiating a maximum fair price
with the manufacturer for a selected drug.
Question. On a related note, will HHS commit to continuing its
longstanding policy of rejecting Bayh-Dole ``march-in'' petitions that
rely primarily on pricing dynamics, given that Senators Bayh and Dole
repeatedly reaffirmed that their law's march-in rights did not
authorize the imposition of de facto price controls?
Answer. The Bayh-Dole Act was designed to promote the
commercialization of research results, maximize the potential for
federally funded technologies to become products, and serve the broader
interest of the American public. HHS is committed to implementing the
law and upholding these aims to support the innovation needed to
deliver new and effective drugs to patients. To that end, HHS has
partnered with the Department of Commerce to review the use of march-in
authority as laid out in the Bayh-Dole Act. Through this partnership,
we have asked an Interagency Working Group to develop a framework for
consistent implementation of the march-in provision across the U.S.
Government that clearly articulates guiding criteria and processes for
making determinations where different factors, including price, may be
a consideration in agencies' assessments. HHS will convene a workshop
in 2023 to further refine the cases for which HHS could consider
exercising march-in authority. HHS will seek input from a diverse array
of interested parties--including patient groups, industry,
universities, small business firms, and nonprofit organizations, as
well as experts in technology transfer and innovation policy. The goal
of the workshop will be to assess when the use of march-in rights is
consistent with the policy and objectives of the Bayh-Dole Act.
comment periods
Question. CMS's decision to offer opportunities for public comment
with respect to the guidance documents governing key programs under the
IRA will hopefully help to inform implementation efforts and minimize
operational concerns. However, given the complexity of the documents
and policies in question, along with the considerable unanswered
questions that remain outstanding, the 30-day comment periods provided
thus far have proven challenging, as policymakers and stakeholders have
attempted to review, consider, and engage on a wide range of policy
matters in a short time.
Will CMS consider providing lengthier comment periods for some
components of IRA program implementation?
Answer. The Inflation Reduction Act directs CMS to implement the
Negotiation Program for 2026, 2027, and 2028 by program instruction or
other forms of program guidance. CMS must meet deadlines set forth in
statute. Of critical importance, the law requires that CMS publish the
selected drug list for initial price applicability year 2026 by
September 1, 2023. CMS recognizes that public input will help to
achieve successful implementation, and so CMS is electing to
voluntarily take comments on certain topics in this initial negotiation
guidance. In order to release initial guidance, voluntarily take
comments, and issue revised guidance as soon as practicable, CMS must
work on an expedited timeline, which necessitates a 30-day comment
period.
In order to facilitate the timely implementation of the Negotiation
Program, CMS is issuing guidance on identification of selected drugs as
final, without a comment solicitation (with the exception of the Small
Biotech Exception Information Collection Request (ICR), for which
comments should be made in response to the ICR).
In the revised guidance, CMS may make changes to any policies,
including policies on which CMS has not expressly solicited comment,
based on the agency's further consideration of the relevant issues.
CMS is committed to collaborating and engaging with the public in
the policymaking process. CMS is working closely with patients and
consumers, Part D plan sponsors and Medicare Advantage organizations,
drug manufacturers, hospitals and health-care providers, wholesalers,
pharmacies, and others. CMS is engaging and will continue to engage
interested parties through national stakeholder calls, quarterly
strategic meetings, and monthly technical calls with CMS staff. In
addition, members of the public are welcome to share feedback and input
in writing by email at: [email protected].
proposed ira price-setting program expansion
Question. The President's Budget proposes expanding the
prescription drug price-setting program enacted under the IRA to
capture more medications each year and to subject drugs to the
selection and price-setting process sooner after their launch. While
the proposal provides no details beyond these broad concepts, reporting
from Bloomberg Law \8\ cited data from the Centers for Medicare and
Medicaid Services (CMS) indicating that under the proposed expansion,
drugs and biologics could be subjected to the so-called negotiation
process as early as 5 years after FDA approval or licensure, and that
the budget proposal would double the number of medications selected for
the program each year.
---------------------------------------------------------------------------
\8\ https://news.bloomberglaw.com/health-law-and-business/biden-
puts-drug-pricing-at-center-of-medicare-spending-debate.
This framework, if adopted, would inevitably slash biomedical
research and development, resulting in fewer new drug discoveries and
approvals in the coming years. Moreover, the proposed expansion would
further erode American intellectual property (IP) protections by
substantially weakening potential economic returns for new drugs, which
currently tend to benefit from roughly 13 to 14 years of patent
protection after FDA approval. With just 5 years of insulation from
government-imposed price controls, which the Secretary can set with no
floor and no opportunity for judicial or administrative review, drugs
and biologics alike would lose crucial incentives for the investments
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that drive their research and development today.
What is the Biden administration's rationale for subjecting drugs
and biologics to the price-setting program after just 5 years?
How does the administration anticipate that the proposed expansion,
if codified, would affect private investment in biomedical research and
development (R&D), as well as in the number of drugs and biologics that
come to market each year?
Have CMS's Office of the Actuary (OACT) or the Congressional Budget
Office (CBO) conducted a budgetary analysis of the proposed price-
setting program expansion?
When does HHS plan to provide more detailed parameters and
specifications of the proposed program expansion to Congress?
Answer. The budget proposal builds on the Inflation Reduction Act
by increasing the number of drugs subject to negotiation and making
drugs eligible for negotiation sooner after their launch. Expanding the
Medicare Drug Price Negotiation Program accelerates the increased gains
in access for Medicare beneficiaries to innovative, life-saving
treatments enacted by the law, with lower costs for people with
Medicare and the program.\9\
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\9\ FY 2024 HHS Budget in Brief, https://www.hhs.gov/sites/default/
files/fy-2024-budget-in-brief.pdf.
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the ira's small-molecule penalty
Question. Under the IRA, small-molecule drugs receive just 9 years
of protection from Secretary-dictated price controls. Given that
roughly half of the return on investment for these products tends to
come between year 9 and year 13 on the market, the price-setting
program thus imposes a de facto penalty on small-molecule medications.
Surveys of manufacturers suggest that many drugmakers plan to steer
R&D investments away from small-molecule products in light of this de
facto small-
molecule penalty. The consequences of forgone innovation in small-
molecule development could prove particularly dire for mental health
conditions, cancer, and Alzheimer's disease. While even providing for
parity between small molecules and biologics under the terms of the
price-setting program by extending the small-molecule exemption period
from 9 years to 13 would still deter longer-term product enhancements
and new indications, alignment would at least mitigate the small-
molecule IP erosion imposed by exposing these products to price
controls roughly 3 to 4 years (on average) before their patent
protections would otherwise end.
Is HHS open to working with Congress to mitigate the aforementioned
small-
molecule penalty by extending the price-setting program exemption
period for these products to more closely align with the exemption
period for biologics?
To what extent is HHS tracking private-sector R&D investments in
small-
molecule and biologic medication candidates in order to monitor
potential effects of the IRA's price-setting program?
Answer. The law requires that at least 7 years, for drugs, or 11
years, for biologicals, must have elapsed between the selected drug
publication date and the FDA approval or licensure, as applicable. We
are implementing the Negotiation Program in accordance with the law.
CMS has been regularly engaging with members of the public to get
their feedback so that we are implementing the Negotiation Program in a
thoughtful way that both improves drug affordability and accessibility
for people with Medicare and supports innovation. We plan to get public
input throughout the implementation of the Negotiation Program to make
sure that we know what is occurring in the market.
ira drug price-setting program implementation funding
Question. CMS has not yet issued a response to a February 22nd
letter \10\ requesting regular briefings and comprehensive reports on
allocation plans regarding the $3 billion in implementation funding
provided under the IRA for the law's drug price-setting program.
Without answers to the questions outlined in the aforementioned letter,
Congress cannot provide meaningful oversight of the initiative's
implementation.
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\10\ https://www.finance.senate.gov/imo/media/doc/
letter_on_ira_implementation_funding1.
pdf.
Given the importance of accountability and good governance, will
CMS provide responses to the questions detailed in the February 22nd
---------------------------------------------------------------------------
letter on a timely basis?
How does CMS plan to ensure meaningful transparency and engagement
with Congress on its plans and operational considerations for using the
funding appropriated for implementation of the price-setting program?
Answer. CMS is prioritizing transparency and outreach, actively
encouraging input and insight from interested parties. We believe that
public feedback is an important part of the implementation process, and
we welcome it.
To that end, on January 11, 2023, CMS published a memo detailing
its approach to implementing the Negotiation Program, including plans
for public engagement through stakeholder calls, quarterly strategic
meetings, and monthly technical calls with CMS staff; plans for program
guidance; a strategy for data collection, including public comment
periods; and upcoming key dates and an estimated timeline for
implementation. Release of this initial memo set the stage for multiple
comment opportunities for members of the public, people with Medicare
and their families, beneficiary and consumer advocates, pharmaceutical
manufacturers, health-care providers, and other interested parties.
On March 15, 2023, CMS issued initial guidance detailing how CMS
intends to implement the Negotiation Program for 2026. Among other
items, the initial guidance details how CMS intends to identify
selected drugs, consider factors in negotiation, conduct the
negotiation process, and establish requirements for manufacturers of
selected drugs. Consistent with our commitment to transparency
throughout implementation of the Negotiation Program, we are seeking
public comment from all interested parties on certain key elements of
the guidance through April 14, 2023. After considering the comments,
CMS anticipates issuing revised guidance for the first year of the
Negotiation Program in Summer 2023.
CMS has kept your staff updated on implementation progress,
including through emails and briefings related to agency actions. We
received the letter referenced in your question and will provide a
response. We will also continue to keep your staff updated as we move
forward.
drug shortages and price controls
Question. Escalating drug shortages pose a major threat to American
patients. According to a recent report from the Senate Committee on
Homeland Security and Governmental Affairs (HSGAC), the number of
active drug shortages reached a recent peak of 295 at the end of last
year,\11\ just months after the IRA's inflation-based price controls
for Medicare Part D medications first went into effect. For a range of
medical conditions, from behavioral health challenges to cancer, these
shortages can result in life-threatening consequences.
---------------------------------------------------------------------------
\11\ https://www.hsgac.senate.gov/wp-content/uploads/Drug-
Shortages-HSGAC-Majority-Staff-Report-2023-03-22.pdf.
Experts and government officials from across the political spectrum
have long recognized the role that pricing dynamics can play in product
shortages, including with respect to prescription drugs. The current
Food and Drug Administration (FDA) Commissioner, for instance, recently
cited weak price incentives as a driver of medication shortages,\12\ in
keeping with the findings from a 2019 FDA report, which concluded that
``[d]rug shortages persist because they do not appear to resolve
according to the `textbook' pattern of market response,'' whereby
``prices rise after a supply disruption and provide an incentive for
existing and new suppliers to increase production until there is enough
supply of a product to meet demand.''\13\ While pricing considerations
fall outside of the FDA's purview, other HHS sub-agencies have tools
and authorities that could help to mitigate medicine shortages and thus
save American lives.
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\12\ https://insidehealthpolicy.com/daily-news/low-generic-prices-
can-lead-drug-shortages-califf-says.
\13\ https://www.fda.gov/media/131130/download.
Unfortunately, the price controls codified under the IRA, including
both the government price-setting program and the inflation-based price
growth penalties for Part B and D drugs, risk exacerbating the
shortages that continue to plague our health-care system. A number of
studies and reports have linked price control policies to product
shortages,\14\, \15\, \16\, \17\ as
noted by Ranking Member Rand Paul during a recent HSGAC hearing.\18\ In
the context of prescription drug manufacturing, price controls dull
incentives for market entry and hamper drugmakers' ability to adopt
conventional and effective market responses to the types of demand
fluctuations and supply chain disruptions that trigger medication
shortages.
---------------------------------------------------------------------------
\14\ https://www.policymed.com/2012/03/increasing-generic-drug-
shortages-linked-to-government-price-controls.html.
\15\ https://www.hsgac.senate.gov/wp-content/uploads/Testimony-
Goodman-2023-03-22.pdf.
\16\ https://alec.org/article/the-truth-about-price-controls-and-
prescription-drug-spending/.
\17\ https://www.cato.org/commentary/problems-price-controls.
\18\ https://www.hsgac.senate.gov/hearings/drug-shortage-health-
and-national-security-risks-underlying-causes-and-needed-reforms/.
The initial guidance documents recently released by CMS regarding
the Part B and D inflation cap policies suggest that the agency plans
to deploy an unduly narrow and potentially counterproductive approach
to the penalty waiver and reduction policies included in the IRA to
account for shortages and supply chain disruptions. Rather than allow
for full penalty waivers for medicines in shortage or in the midst of
significant supply chain disruptions, which would help to address the
shortage risks posed by the inflation rebate policies, CMS's initial
guidance materials propose only partial reductions, including one
option that would increase penalties over time for drugs remaining in
shortage, thus presumably exacerbating, rather than mitigating, the
type of strain that often triggers shortages in the first place. In the
context of shortages, the market needs flexibility to respond and
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adapt, not onerous penalties and rigid pricing requirements.
Furthermore, while CMS's guidance documents raise concerns around
the potential for manufacturers, in the face of full penalty waivers,
to ``game'' the system by prolonging drug shortages, this worry
disregards basic economics. Drugmakers confront major financial,
reputational, and regulatory incentives to minimize and address
shortages, insofar as they have the tools available to do so. In
finalizing its guidance documents, CMS should maximize these tools by
ensuring full penalty waivers for drug shortages and severe supply
chain disruptions, in keeping with the apparent intent of the relevant
IRA provisions.
Will CMS commit, in finalizing its guidance for the Part B and D
inflation rebate policies, to mitigating drug shortage risks by
enabling full penalty waivers for medications in shortage and products
facing severe supply chain disruptions?
Answer. The law requires CMS to reduce or waive the rebate amount
for certain rebatable drugs, such as those ``currently'' on the FDA
drug shortage list, a Part B or Part D rebatable drug that is a
biosimilar biological product and experiencing a severe supply chain
disruption, or a Part D rebatable drug that is a generic and
experiencing a severe supply chain disruption or if the Secretary
determines it is likely to be described as in shortage in the next
applicable period without a reduction or waiver.
CMS has requested comment on specific scenarios CMS should consider
for purposes of reducing or waiving the rebate in the case of a
shortage or severe supply chain disruptions, and approaches CMS could
use to reduce or waive the rebate amount. CMS intends to structure this
policy such that it does not create incentives for manufacturers to
intentionally maintain their drug or biological in shortage.
Question. What other steps do HHS and its sub-agencies plan to take
to address the rash of drug shortages currently imperiling patients'
access to care?
Answer. Ensuring and increasing the availability of safe and
effective medicines are key priorities for FDA. We recognize that not
having access to necessary drug products is a serious concern. FDA
helps prevent and resolve shortages in various ways, such as through
expediting its reviews of new production lines or material sources to
increase production, reviewing requests for extensions of product
expiration dating, helping manufacturers identify root causes of
shortages, and exercising temporary regulatory flexibility for new
sources of medically necessary drugs. In addition to working directly
with manufacturers, FDA is closely collaborating with Federal
Government partners to respond to surges in demand. As a part of the
President's Fiscal Year (FY) 2024 budget request, the agency has also
requested additional authorities to ensure greater insight and
transparency into the supply chain, including requirements for
manufacturers to both notify FDA when they will be unable to meet an
increase in demand and to enhance their reporting to the agency on drug
manufacturing amounts. We look forward to working with Congress on
these proposals.
drug price-setting program
Question. Under the IRA's drug price-setting program, the ceiling
for Secretary-dictated prices will decline over time, rendering
medications affected by the program less and less profitable as they
move from one statutory category to the next, regardless of any product
improvements or new indications (which the law thus discourages), and
irrespective of patent protections and exclusivities (which the law
thus weakens). Moreover, given that the IRA includes no floor for the
prices imposed under the program, manufacturers could feasibly face
``penny-pricing'' for older drugs, as drugmakers sometimes currently
confront under the 340B Drug Discount Program.
Given the declining window for profitability under the price-
setting program, some manufacturers may opt to discontinue certain
drugs in the face of unsustainably low government price limits.
Meanwhile, these same sub-market maximum fair price (MFP) ceilings will
likely deter prospective generic or biosimilar market entrants, given
the lack of opportunity for a reasonable return on investment. These
dynamics could easily trigger medication shortages by gutting
incentives for both the originator drug and potential generic or
biosimilar competitors to stay on the market.
In developing initial guidance for the drug price-setting program,
has CMS considered and/or addressed the risk of triggering or
exacerbating shortages for selected products?
What strategies or tools does the agency plan to employ in order to
address or mitigate the shortage risks posed by the implementation of
this program?
How, more broadly, do HHS and CMS anticipate that the drug price-
setting program will impact the prospective generic and biosimilar
markets for selected products? Have the agencies quantified this
impact, and if not, do they plan to do so?
Answer. CMS supports innovation and believe it is vitally important
that beneficiaries have access to innovative new therapies. The law
requires the Secretary to negotiate directly with manufacturers, in an
offer/counteroffer process, in order to arrive at a maximum fair price
and consider specific factors in the negotiation process. CMS has been
regularly engaging with members of the public to get their feedback so
that we are implementing the Negotiation Program in a thoughtful way
that both improves drug affordability and accessibility for people with
Medicare and supports innovation. We plan to get public input
throughout the implementation of the Negotiation Program to make sure
that we know what is occurring in the market.
extending the inflation-based price controls to the commercial market
Question. The budget proposes extending the IRA's inflation-based
price controls to the commercial market, resulting in a sweeping new
private-sector mandate, even as the core policies enacted last year
have triggered higher launch prices and other market distortions.\19\
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\19\ https://www.wsj.com/articles/inflation-reduction-drug-prices-
11673628922.
Apart from the catastrophic price controls of the 1970s, which
virtually all experts and policymakers now see as a disastrous unforced
error,\20\ can you point to a precedent for the type of far-reaching
price controls that the administration has proposed here?
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\20\ https://www.wsj.com/articles/nixon-fight-inflation-price-
controls-stagflation-gas-shortages-biden-democrats-reconciliation-bill-
federal-reserve-11628885071.
Answer. The Inflation Reduction Act requires manufacturers to pay
rebates to Medicare when drug prices for certain rebatable Medicare
Part B or Part D drugs rise at a rate that is faster than the rate of
inflation. The budget includes a proposal to revise the formula to
calculate these rebates beyond Medicare utilization to include drug
units used by commercial plans. Doing so would provide additional
savings while discouraging manufacturers from raising drug prices for
commercial coverage including employer-sponsored plans, marketplace
plans, and other individual and group market plans.\21\
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\21\ FY 2024 HHS Budget in Brief, https://www.hhs.gov/sites/
default/files/fy-2024-budget-in-brief.pdf.
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home oxygen access
Public Health Emergency Waivers
Question. For many Medicare beneficiaries living with chronic
conditions like COPD and ALS, the home respiratory therapy
flexibilities provided by CMS in the context of the public health
emergency (PHE) have proven pivotal to ensuring access to medically
necessary care. As patients, providers, and policymakers prepare for
the impending termination of the PHE, many have raised questions
regarding the agency's transition plans, particularly for seniors who
originally qualified for the home oxygen benefit pursuant to the
agency's temporary policy waivers. If required by CMS to requalify for
home respiratory therapy once the emergency period concludes, these
patients, along with their medical providers, could face significant
hurdles, especially in rural and underserved areas with physician
shortages.
In light of these substantial burdens, does CMS plan to grandfather
initial home oxygen benefit eligibility determinations made during the
PHE?
What additional clarity can the agency provide with respect to the
upcoming transition for beneficiaries who depend on home respiratory
therapy and originally qualified for this benefit pursuant to PHE-
related waivers and flexibilities?
Answer. CMS recognizes that it is important for stakeholders to
understand how CMS anticipates performing medical review after the
Public Health Emergency (PHE) has ended. During the PHE, flexibilities
were applied to medical reviews across claim types. For certain DME
items, this included the non-enforcement of clinical indications for
coverage. Since clinical indications for coverage were not enforced for
certain DME items provided during the PHE, once the PHE ends CMS plans
to primarily focus reviews on claims with dates of service outside of
the PHE, for which clinical indications of coverage are applicable. CMS
may still review these DME items, as well as other items or services
rendered during the PHE, if needed to address aberrant billing
behaviors or potential fraud. The HHS Office of the Inspector General
may perform reviews as well. All claims will be reviewed using the
applicable rules in place at the time for the claim dates of service.
As the PHE comes to an end, CMS will continue to work with stakeholders
to ensure beneficiary access.\22\, \23\
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\22\ Spotlight | CMS, https://www.cms.gov/about-cms/components/cpi/
cpi-spotlight.
\23\ Medicare Fee-for-Service Compliance Programs | CMS, https://
www.cms.gov/research-statistics-data-and-systems/monitoring-programs/
medicare-ffs-compliance-programs/overview.
---------------------------------------------------------------------------
documentation requirements
Question. Many patients who rely on home respiratory therapy have
also raised concerns regarding the documentation used to demonstrate
medical necessity for these items and services, particularly in light
of CMS's elimination of certificate of medical necessity (CMN)
requirements in the context of the agency's final national coverage
determination (NCD) for Home Use of Oxygen, as issued in September
2021. Given the issues presented by exclusive reliance on physicians'
subjective and un-standardized medical record notes to establish
medical necessity, some patient advocates have suggested that CMS adopt
and implement a standardized home oxygen template incorporating
clinical data elements (CDE) to ensure a streamlined, objective, and
consistent means of documenting medical necessity.
Given that CMS has already developed a template along these lines,
why has the agency opted not to move forward with implementation of a
standardized CDE template for home oxygen therapy to this point?
Will the agency consider adopting such a template, to be used in
lieu of paper records, moving forward?
Answer. CMS has designed printable clinical templates and suggested
clinical data elements (CDEs) to assist providers and IT professionals
with data collection and medical record documentation to support
coverage of selected items and services. These templates and suggested
CDEs are intended to help reduce the risk of claim denials and ensure
that medical record documentation is more complete.\24\ Specifically,
CMS released a clinical template and suggested CDEs for ordering home
oxygen therapy. The template is designed to assist a clinician when
completing an order for home oxygen therapy to meet requirements for
Medicare eligibility and coverage. The template meets the requirements
for both the Detailed Written Order and Written Order Prior to
Delivery, and is available to the clinician and can be kept on file
with the patient's medical record or can be used to develop an order
template for use with the system containing the patient's electronic
medical record. While completing the ``Home Oxygen Therapy Order
Template'' does not guarantee eligibility and coverage, it does provide
guidance in support of home oxygen therapy equipment and services
ordered and billed to Medicare. CMS has also released clinical
templates and suggested CDEs for documenting the face-to-face encounter
for Medicare home oxygen therapy eligibility and coverage and for
documenting information regarding home oxygen therapy laboratory test
results to meet requirements for Medicare coverage for home oxygen
therapy. The home oxygen therapy templates and suggested CDEs are
available at: https://www.cms.gov/Research-Statistics-Data-and-Systems/
Computer-Data-and-Systems/Electronic-Clinical-Templates/template-and-
CDE-downloads.\25\
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\24\ Clinical Templates--HOME | CMS, https://www.cms.gov/research-
statistics-data-and-systems/computer-data-and-systems/electronic-
clinical-templates.
\25\ Home Oxygen Therapy Order Template (https://www.cms.gov/
Research-Statistics-Data-and-Systems/Computer-Data-and-Systems/
Electronic-Clinical-Templates/Downloads/Home-Oxygen-Therapy-Order-
Template-Draft-20180619-V42.pdf).
At this time, use of these templates and suggested CDEs is
voluntary; however, we welcome provider and stakeholder feedback and
suggestions on how to improve all our templates and CDEs.
patient access to medications
Question. Numerous health-care providers have raised concerns
regarding the potential implications of a guidance document issued by
CMS on September 20, 2021, regarding the in-office ancillary services
exception under the Physician Self-Referral (Stark) Law. Specifically,
many oncology and urology physician practices report having
conventionally provided cancer patients with the flexibility, at said
patients' election, of receiving outpatient prescription drugs (a
designated health service, under the relevant exception) through mail-
order services facilitated by a physician practice's pharmacy (or
physician-owned pharmacy). Some practices have also traditionally
allowed the spouses or caregivers of patients to pick up medically
necessary drugs on their behalf through these facilities, under the
relevant Stark Law exception.
Some of the language included in the September 2021 frequently
asked questions (FAQ) document appears to reflect a substantive
departure from the past regulatory treatment of these types of DHS
arrangements. To that point, numerous pharmacy boards, for instance,
distinguish ``dispensing,'' as included in the applicable regulatory
text, from the conduit of delivery (i.e., in these cases, the use of a
mail carrier to deliver drugs dispensed by a practice's pharmacy or
physician-owned pharmacy). As practices prepare for the end of the PHE
and its associated Stark flexibilities, they have expressed concerns
over the potential use of the guidance document to prohibit the patient
option of mail delivery of drugs from these facilities, which could
pose serious access challenges.
Given the access implications and the apparent shift from
prevailing regulatory treatment, can CMS clarify whether, under current
Stark Law interpretation, mail-order drugs would be excluded from the
in-office ancillary exception?
If the agency currently regards mail-order drugs as excluded from
the exception, would CMS consider leveraging additional authorities to
provide an exception to the Stark Law's relevant location requirement
in order to avert potential disruptions to patient access to medically
necessary care?
In 2001, CMS issued a regulation enabling mobile facilities used
exclusively by a group practice to count under the relevant Stark Law
exception. Would the agency consider taking a similar approach here?
Answer. CMS has not changed its policy when it comes to enforcing
the Physician Self-Referral Law (PSL) that regulates when referrals may
be made for certain services. Congress has specified certain exceptions
to the PSL in statute. One exception specified by Congress is known as
the in-office ancillary exception. This exception permits physicians to
supply services and items, such as drugs, to beneficiaries in the
physician office. However, the statute does not allow physicians to
mail drugs directly to beneficiary homes without the beneficiary coming
into the office. During the COVID-19 Public Health Emergency (PHE), CMS
issued a waiver of the terms of this exception to make sure
beneficiaries could receive items at home. That waiver will end on May
11th.
CMS does not anticipate or is not aware of any access issues
related to the end of this waiver, because beneficiaries have always
had options in obtaining Part D drugs, including being able to get them
directly via mail order from pharmacies. Part D plans must meet robust
requirements aimed at ensuring beneficiaries can obtain the Part D
drugs they need.
multi-cancer early detection screening
Question. As the Biden administration has acknowledged, advances in
screening technology and uptake will play a key role in efforts to
combat cancer. Studies suggest that detecting cancer at an early stage
can lead to survival rates roughly 5 to 10 times greater than for late-
stage detection.
That said, around 70 percent of cancer deaths in the U.S. occur in
conditions with no recommended screening options.
Multi-cancer early detection (MCED) testing technologies have the
potential to revolutionize the screening landscape, leveraging rigorous
research and cutting-edge scientific developments to detect as many as
dozens of different cancer types, often long before symptoms even
emerge. Once developed, approved, and brought to market, these tests
could increase the cancer survival rate, expand and enhance treatment
options, and reduce health-care costs.
Last Congress saw the reintroduction of Medicare Multi-Cancer Early
Detection Screening Coverage Act, legislation that would establish a
Medicare coverage pathway for FDA-approved MCED screening tests. More
than 315 State, local, and national groups, ranging from patient
advocacy organizations and labor unions to chambers of commerce and
frontline health-care providers, endorsed the proposal, which attained
54 cosponsors in the Senate and 257 in the House, illustrating
sweepingly broad bipartisan support.
Will you commit to working with the bill's sponsors in the Senate
and House to advance this legislation, given its potentially life-
saving effects and its alignment with the President's Cancer
Moonshot?\26\
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\26\ https://www.finance.senate.gov/imo/media/doc/
letter_to_president_biden_on_multi-
cancer_early_detection_legislation.pdf.
Answer. One year ago, President Biden reignited the Cancer Moonshot
and set new national goals to cut the death rate from cancer by at
least 50 percent over the next 25 years and improve the experience of
people and their families living with and surviving cancer.\27\ At HHS,
we are doing all we can to make cancer prevention and screening
services accessible to everyone in the United States, including taking
action to address the estimated 9.5 million cancer screenings missed
during the pandemic.\28\ The Department looks forward to hearing more
from you about how we can explore options to increase access to
preventive health services, including cancer screenings. HHS always
appreciates the opportunity to provide technical assistance to Congress
on important health-care issues.
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\27\ Cancer Moonshot | The White House, https://www.whitehouse.gov/
cancermoonshot/.
\28\ On First Anniversary of the President's Reignited Cancer
Moonshot, the Biden-Harris Administration Awards Nearly $11 Million to
Address Disparities in Cancer Screening and Follow-Up Care, https://
www.hhs.gov/about/news/2023/02/02/on-first-anniversary-presidents-
reignited-cancer-moonshot-biden-harris-administration-awards-nearly-11-
million-address-disparities-cancer-screening-follow-up-care.html.
As a central component of the Cancer Moonshot, in 2024, the
National Cancer Institute is launching a new research network to study
cancer screening, including evaluating the effectiveness of new blood
tests for the detection of one or more cancers to prevent cancer-
related deaths. This effort is in addition to other NCI supported
research related to MCED tests.
medicare telehealth coverage
Question. Without additional congressional action, the Medicare
coverage flexibilities for telehealth services that are currently in
effect will expire at the end of calendar year (CY) 2024, creating an
access cliff for beneficiaries.
Does the Biden administration support extending some or all of
these coverage flexibilities beyond CY 2024?
Will HHS and its sub-agencies commit to working with Congress on a
bipartisan and bicameral basis to develop long-term Medicare coverage
solutions that ensure access to telehealth services?
Answer. In response to the COVID-19 public health emergency, which
is set to expire in May 2023, flexibilities for Medicare telehealth
services were issued through legislative and regulatory authorities to
increase access to care for patients and providers. The Consolidated
Appropriations Act of 2023 recently extended many of these
flexibilities through December 31, 2024. Extended telehealth
flexibilities include waiving geographic and site of service
originating site restrictions so that Medicare patients can continue to
use telehealth services from their home and allowing audio-only
telehealth services. Additionally, the expanded list of providers
eligible to deliver telehealth services is also extended so Medicare
beneficiaries can continue to receive telehealth services furnished by
physical therapists, occupational therapists, speech language
pathologists, and audiologists, as well as receive telehealth services
from Rural Health Clinics and Federally Qualified Health Centers
through December 31, 2024. If you are interested in drafting
legislation to make these waivers permanent, CMS would be happy to
provide technical assistance.
Additionally, recent legislative and regulatory changes made
several telehealth flexibilities permanent. Federally Qualified Health
Centers and Rural Health Clinics can furnish certain behavioral and
mental health services via telecommunications technology. Medicare
patients can continue to receive these telehealth services in their
home as geographic restrictions on the originating site are eliminated
for these telehealth services. Certain behavioral and mental telehealth
services can be delivered using audio-only communication platforms, and
rural emergency hospitals can serve as an originating site for
telehealth services.\29\
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\29\ FY 2024 HHS Budget in Brief (p. 69-70), https://www.hhs.gov/
sites/default/files/fy-2024-budget-in-brief.pdf.
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tcet and access to breakthrough devices
Question. Too often, seniors lack efficient access to medical
breakthroughs, due in part to outdated Medicare coverage policies.
Disappointingly, in 2021, the Biden administration rescinded the
Medicare Coverage of Innovative Technology (MCIT) final rule, which
would have created an expedited coverage pathway for FDA-
designated breakthrough devices. This decision came in spite of robust
bipartisan support for the MCIT regulation.\30\, \31\
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\30\ https://files.constantcontact.com/14c6814f001/f2a3faa1-655d-
456f-a1ff-1f7bbb7cfc34.pdf.
\31\ https://www.dropbox.com/s/c6lsl41ecji4eq9/
Letter%20on%20MCIT%20Rule.pdf?dl=0.
When does the administration plan to issue a formal proposed rule
for transitional coverage of innovative technologies, and how will it
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differ from the MCIT regulation that CMS rescinded in 2021?
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 has conducted 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.
average sales price-related clarifications
Question. Under the multiple best prices reporting option (MBPRO),
a manufacturer reports two different ``best prices'' (BPs): a value-
based BP and a non-value-based BP. Patient advocates, providers, and
other stakeholders have requested clarity as to whether, for Medicare
Part B payment purposes, the average sales price (ASP) for a product
leveraging MBPRO should be calculated with respect to the value-based
or non-value-based BP.
HHS OIG has cited the lack of clarity on this front as warranting
attention, with a recent report noting, ``Without clear guidance,
manufacturers argue that they will need to adopt varying reasonable
assumptions that could create distortions among reported ASPs.''\32\
Enabling manufacturers to report ASP based on the sales and discounts
considered in determining the non-value-based BP, as opposed to the
value-based BP, would create more clarity and consistency, mitigating
disincentives currently preventing some drugmakers from availing
themselves of MBPRO.
---------------------------------------------------------------------------
\32\ https://oig.hhs.gov/oei/reports/OEI-BL-21-00330.pdf.
Can a manufacturer who elects MBPRO calculate ASP by reference to
the sales and discounts considered in the determination of the non-
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value-based BP? If not, why not?
If a manufacturer may do so, can CMS commit to issuing clarifying
guidance promptly to address this issue? If not, why not?
Answer. CMS appreciates the OIG's work on this area and look
forward to working collaboratively on this and other issues in the
future. In their report, OIG recommended that CMS actively review
current guidance related to the areas identified in this report and
determine whether additional guidance would ensure more accurate and
consistent ASP calculations. CMS agrees with this recommendation and
will review the current guidance related to the areas identified in
OIG's report and determine whether additional guidance would help to
ensure more accurate and consistent ASP calculations. It should be
noted that in some cases, additional guidance could be sub-regulatory,
and in others, it may potentially require notice and comment
rulemaking.
physician payment reform
Question. In recent years, Congress has come together on a
bipartisan basis to enact a series of Medicare physician payment
increases, mitigating some of the challenges confronted by our front-
line providers, particularly as inflation continues to flare. While
constructive in the short term, this ad-hoc approach creates
uncertainty and volatility for clinicians across the country,
especially in rural communities.
What specific policies would the administration propose to achieve
a sustainable path forward for physician payment reform, driving value-
based care and restoring predictability?
Answer. The Biden-Harris administration is committed to protecting
and strengthening Medicare so that Americans of every generation can
count on it. Ensuring adequate payment rates for physicians and other
health-care professionals is essential in maintaining patients' ability
to access high-quality and affordable health care. CMS is required to
base payments for services under the physician fee schedule on the
relative resource costs involved in furnishing a service, and the fee
schedule is subject to statutory budget-neutrality requirements. CMS
does not have the legal authority to implement increases in payment
outside of budget neutrality without additional action taken by
Congress.
medicaid state burden and the federal commitment to states
Question. Last December, Congress acted on a bipartisan basis to
allow States to begin returning their Medicaid programs to post-
pandemic normalcy. This effort is essential to protecting hardworking
taxpayers' dollars, but it will demand States' attention and resources,
as well as HHS's partnership and flexibility.
Unfortunately, last September, HHS proposed a rule that would only
complicate States' efforts to rebalance their Medicaid programs and
budgets. The new enrollment and eligibility requirements would
exacerbate States' administrative and fiscal burden, and risk making an
already massive undertaking even more inefficient.
Can you commit that HHS will not finalize this proposed rule until,
at a minimum, States have concluded their pandemic-related
redeterminations process?
Answer. In September 2022, CMS issued a proposed rule \33\ that
includes several provisions aimed at simplifying the enrollment process
and maintaining continuity of coverage for eligible beneficiaries,
including children and individuals dually enrolled in Medicare and
Medicaid, many of whom are over 65 and/or have a disability. CMS
estimates that this proposed rule would remove barriers to enrollment
and increase the number of eligible individuals who obtain coverage and
are continuously enrolled in Medicaid and CHIP.\34\ Recognizing that
most States will require up to 12 months to implement the changes
proposed in this rule, we sought public comment on making the final
rule effective 30 days after publication with full compliance required
12 months later. The comment period for the proposed rule closed on
November 7, 2022. CMS is taking into consideration comments received
for final decision making.
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\33\ Streamlining Eligibility and Enrollment Notice of Propose
Rulemaking (NPRM) | CMS, https://www.cms.gov/newsroom/fact-sheets/
streamlining-eligibility-enrollment-notice-propose-rulemaking-nprm.
\34\ Streamlining Eligibility and Enrollment Notice of Propose
Rulemaking (NPRM) | CMS, https://www.cms.gov/newsroom/fact-sheets/
streamlining-eligibility-enrollment-notice-propose-rulemaking-nprm.
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pediatric mental health
Question. Pediatric mental health providers continue to struggle in
their recruitment and retention efforts at a time of immense need.
Recently, there has been increased use of FDA-cleared digital
technologies that can deliver evidence-based mental health treatments
for children. These treatments could be promising and innovative
solutions for State Medicaid programs, particularly where there are few
pediatric mental providers in a State or region.
Does CMS have a plan to provide technical support to States that
want to adopt coverage and payment for these digital technologies under
existing Medicaid authorities and payment allowances?
Question. CMS works closely with States as they examine innovative
ways to improve their Medicaid programs and address the specific needs
of their residents, and CMS works closely with its Federal partners,
like FDA, to ensure access to safe and effective interventions for
mental health conditions and substance use disorders.
Additionally, States have a great deal of flexibility with respect
to covering telehealth services in their Medicaid programs, including
mental health services provided via telehealth, and States are not
required to submit a State plan amendment (SPA) to pay for telehealth
services if payments for services furnished via telehealth are made in
the same manner as when the service is furnished in a face-to-face
setting. To establish rates or payment methodologies for telehealth
services that differ from those applicable for the same services
furnished in a face-to-face setting, a State would need an approved
State plan payment methodology and might need to submit a SPA.\35\ We
look forward to continuing to work with States as they consider these
and other innovative coverage decisions in their Medicaid programs.
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\35\ Medicaid State Plan Fee-for-Service Payments, https://
www.medicaid.gov/sites/default/files/2020-03/
Medicaid%20telehealth%20services.pdf.
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the medicare hospital insurance (hi) trust fund
Question. Transferring general tax revenue into Medicare's hospital
insurance trust fund in order to make the program more solvent would be
unprecedented. Similar to the Social Security system, the HI portion of
the Medicare program was designed to be self-supporting. The Medicare
Part A trust fund has a dedicated revenue stream--the HI payroll tax.
Beneficiary services are financed through that reserved income source,
rather than relying on general tax revenues. Congress only allowed
temporary, and time-limited, general transfers to the HI trust fund
during the first few years of the Medicare program's implementation.
General revenue has never been used for the purpose of expanding
Medicare program benefits or extending HI trust fund solvency.
The President's budget request appears to rely solely on massive
tax hikes and budget gimmicks to delay Medicare insolvency. Mr.
Secretary, are you concerned that transferring general tax revenue into
the HI trust fund would undermine the self-financing structure of the
trust fund?
The Penn Wharton Budget Model, an organization respected by both
sides of the aisle, estimates that almost 40 percent of the revenue
attributed to the President's proposal comes from redirecting current-
law revenue into the HI trust fund account. Do you agree that shifting
tax revenue into the HI trust fund would require tax increases in other
areas, new taxes, or deficit increases in order to compensate for the
lost revenue streams?
Answer. Medicare is a key pillar of our health-care system and we
are committed to strengthening the program both now and in the future.
Thanks to our efforts, this year's Medicare Trustees Report estimated
that the solvency of the Medicare hospital insurance (HI) trust fund
has been extended by 3 years since last year's report. In addition,
adoption of the proposals in the President's FY 2024 budget would
extend Medicare solvency by at least 25 years, without cutting benefits
or raising costs for people with Medicare. The FY 2024 budget also
includes a targeted package of Medicare proposals totaling $8 billion
over 10 years that supports the administration's priorities such as
investing in mental health, strengthening nursing home oversight, and
enhancing program benefits. We look forward to continuing to work with
Congress to further strengthen this vital program that serves over 65
million Americans.\36\
---------------------------------------------------------------------------
\36\ FY 2024 HHS Budget in Brief, https://www.hhs.gov/sites/
default/files/fy-2024-budget-in-brief.pdf.
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faith-based adoption agencies
Question. Public-private partnerships between State child welfare
agencies and faith-based organizations help to fill critical gaps in
State foster care and adoption programs. In addition to connecting
children with safe and loving homes, faith-based organizations provide
support, resources and other services to vulnerable children and their
families.
Critical to the work of faith-based organizations is ensuring that
they can continue to operate, without discrimination, in accordance to
the tenants of their faith.
How does your budget ensure that faith-based adoption agencies are
supported in their work to serve children and families?
Answer. Faith-based providers are an important part of the Nation's
foster care systems, and the budget proposes to expand foster care
prevention and other services that are provided by a range of child
welfare organizations, including faith-based providers, while ensuring
that all children and families involved in the child welfare system are
able to access publicly funded services without facing discrimination.
The work of the Children's Bureau, including funding programs and
providing training and technical assistance supports the faith-based
adoption agencies equally along with the publicly operated agencies.
Examples of this support is provided by the following:
The multifaceted national AdoptUSKids Project:
Featured articles in newsletters and blogs such as:
Partnering With Faith Based Communities To Secure Families.
Faith-Based organizations have access to and use the
National Photolisting site to highlight children/youth needing
an adoptive family and families available to meet the needs of
waiting children.
Recruitment of and highlighting of families and youth with
lived experience from faith-based organizations are key member
of the project's Speakers Bureau.
Media Interviews are conducted to highlight the need for
adoptive and foster families with faith-based organizations.
Faith-based organizations can personalize the public service
announcements produced by this project each year for their
recruitment campaigns.
The importance of faith-based communities is highlighted on
the AdoptUSKids website and in the national and tailored
service work conducted through the project's capacity building
efforts to include diligent recruitment efforts with all
States, tribes, and territories.
Recruitment occurs on a continual basis that targets faith-
based organizations to refer candidates for the Minority
Professional Leadership Development program designed to develop
leadership within child welfare systems.
Several national projects funded with Adoption Opportunities funds
have and continued to make an impact in terms of support for faith-
based agencies across the Nation. Examples include:
National Training and Development Curriculum: This project
developed and continues to infuse within public and private
(including faith-based) agencies a state-of-the-art,
comprehensive training and development curriculum for foster
and adoptive families. This training is made free of charge to
all agencies and support the pre-service and ongoing
developmental training needs for adoptive families to ensure
safe and stable permanencies.
Quality Improvement Center for Adoption/Guardianship Support
and Services: This project developed and tested models of post
adoption support that involved many faith-based agencies and
continues to support the efforts of post adoption support to
these agencies.
Hospital-based training for adoption support among hospital
staff has supported many efforts with faith-based agencies.
National Training Initiative for Adoption-Competent Mental
Health Services has developed web-based training that is made
available to all child welfare agencies across the Nation
including faith-based agencies.
aca premium tax credits
Question. The President's budget proposes permanently authorizing
the expanded Obamacare premium tax credits that were most recently
extended in the Inflation Reduction Act. Earlier this month, the U.S.
Government Accountability Office released a report finding that CMS
does not coordinate with States to conduct risk assessments to evaluate
the likelihood of improper eligibility determinations for the advance
premium tax credit.
Do you agree with these findings, and what steps are you taking to
ensure proper oversight of the expanded and enhanced premium tax
credits?
Answer. In 2010, the Patient Protection and Affordable Care Act
(ACA) established Health Insurance Exchanges through which consumers
could submit applications and enroll in health coverage. Under the law,
States have the authority to establish their own exchange, a State-
Based Exchange (SBE), or use the Federally Facilitated Exchange (FFE).
HHS works with all States to address the specific needs of their
consumers while also meeting the requirements and responsibilities set
by statute. Eligible consumers enrolling in a qualified health plan
through the FFE or SBE may receive financial assistance in the form of
Advance Payments of the Premium Tax Credit (APTC). HHS is committed to
protecting taxpayer funds while reducing the burden on consumers,
employers, and other individuals and entities involved in the FFE and
SBEs and other insurance affordability programs.
HHS has applied program integrity best practices to the Exchanges
based on efforts to prevent and detect fraud, waste, and abuse in its
other programs. In addition, HHS has experienced program integrity
staff that work to prevent and address instances of potential fraud.
HHS has also made progress toward reporting APTC improper payment
estimates by conducting a risk assessment for the APTC program, as
required by the Payment Integrity Information Act of 2019 and Office of
Management and Budget guidance. HHS also requires SBEs to conduct a
defined set of oversight activities, and tracks and monitors how SBEs
establish program integrity standards that comply with Exchange-related
policy and operational requirements set forth in statute, regulations,
and guidance.\37\
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\37\ Payment Integrity: Additional Coordination Is Needed for
Assessing Risks in the Improper Payment Estimation Process for Advance
Premium Tax Credits | U.S. GAO, https://www.gao.gov/products/gao-23-
105577.
In November 2022 HHS for the first time included measurements of
the improper payment rate for the APTC program for the FFE in CMS's and
HHS's annual 2022 Agency Financial Report. CMS reported the improper
payment rate for Benefit Year 2020 (January 1st to December 31, 2020).
CMS found that the FFE properly paid an estimated 99.38 percent of
total outlays in Benefit Year 2020. The improper payment rate for the
program was 0.62 percent.\38\ HHS estimated the improper payment rate
based on a review of a stratified random sample of applications to
determine if the FFE properly performed the required eligibility
determinations and paid the appropriate benefits for each sampled
application. Most improper payments involve situations where a State or
provider missed an administrative step. The vast majority of improper
payments are not fraud, and improper payment estimates are not fraud
rate estimates. The primary causes of improper payments were manual
errors associated with determining consumer eligibility for payments
when verification by automated processes was insufficient or not
possible. An improper payment could arise, for example, if a consumer
is determined eligible for payments based on submitted documentation
that did not meet requirements.\39\ HHS continues to develop the
improper payment measurement program for SBEs and will continue to
provide updates on the development status of the SBE improper payment
measurement through its annual Agency Financial Report.
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\38\ Federally Facilitated Exchange Improper Payment Rate Less Than
1 Percent in Initial Data Release | CMS, https://www.cms.gov/newsroom/
press-releases/federally-facilitated-exchange-improper-payment-rate-
less-1-initial-data-release.
\39\ Federally Facilitated Exchange Improper Payment Rate Less Than
1 Percent in Initial Data Release | CMS, https://www.cms.gov/newsroom/
press-releases/federally-facilitated-exchange-improper-payment-rate-
less-1-initial-data-release.
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the broken coverage with evidence development paradigm
Question. Medicare's coverage with evidence development, or CED,
paradigm, desperately needs reform, as experts across the political
spectrum have contended. In addition to creating access barriers for
countless seniors through rigid trial and study requirements, which can
also trigger massive costs, with no guarantee of a reasonable return,
CED protocols rarely come with a realistic or transparent path to full
coverage, even for the most promising medical devices. Underscoring
that point, of the 27 CED decisions issued since 2005, only four have
ultimately been retired, after a staggering average of 8 years.\40\
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\40\ https://www.agingresearch.org/wp-content/uploads/2023/02/
Facade-of-Evidence-CED-2-13-2023.pdf.
Moreover, the application of this pathway to drugs and biologics
flies in the face of statute, regulation, and longstanding precedent,
exacerbating uncertainty, especially for the small businesses that
drive an outsize share of innovative drug development.\41\
Unfortunately, rather than defer to FDA's judgment on medications and
improve the CED paradigm for devices, CMS has doubled down on its
onerous Alzheimer's coverage decision and considered only narrow, and
sometimes counterproductive, changes to the CED process more broadly.
---------------------------------------------------------------------------
\41\ https://www.finance.senate.gov/imo/media/doc/
crapo_letter_to_cms_on_final_coverage_
decision.pdf.
What concrete steps will your department and its sub-agencies take
to enhance CED and to ensure that seniors can access FDA-approved
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medicines without needless hurdles and barriers?
Answer. Medicare's Coverage with Evidence Development (CED) is a
paradigm whereby Medicare covers items and services on the condition
that they are furnished in the context of approved clinical studies or
with the collection of additional clinical data. In making coverage
decisions involving CED, CMS decides after a formal review of the
medical literature to cover an item or service only in the context of
an approved clinical study or when additional clinical data are
collected to assess the appropriateness of an item or service for use
with a particular beneficiary. Coverage in the context of ongoing
clinical research protocols or with additional data collection can
expedite earlier beneficiary access to innovative technology while
ensuring that systematic patient safeguards, including assurance that
the technology is provided to clinically appropriate patients, are in
place to reduce the risks inherent to new technologies, or to new
applications of older technologies.\42\
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\42\ Medicare Coverage Document--Guidance for the Public, Industry,
and CMS Staff: Coverage With Evidence Development, https://www.cms.gov/
medicare-coverage-database/view/medicare-coverage-
document.aspx?MCDId=27.
The FDA performs a vital and an important role. CMS recognizes the
important and related--but different--roles of the respective agencies.
The FDA determines whether to approve a new medical product based on a
careful evaluation of the available data and a determination that the
medical product is safe and effective for its intended use. CMS
conducts its own independent review to determine whether an item or
service is reasonable and necessary for use in the Medicare population
and should be covered nationally by Medicare.
ensuring a robust biosimilar pipeline
Question. Biosimilars present a pivotal opportunity for cost
savings, both for patients and for our health-care programs. The FDA
has approved at least 40 of these products to date, and in the past 7
years, biosimilars have generated more than $13 billion in savings,
with prices averaging just 50 percent of their branded competitors.
In Medicare Part D, however, uptake has proved lower than expected,
jeopardizing the biosimilar pipeline and driving up out-of-pocket
spending. A recent report from HHS's Office of the Inspector General
found that beneficiaries could have realized savings of 12 percent in a
single year with greater biosimilar uptake. As a case in point, even
with the first Humira biosimilar competitor on the market, and with at
least seven more to come before the end of 2023, Part D coverage has
been uneven and distorted, with some plans and PBMs advantaging the
branded product--or biosimilars with a higher sticker price.
What specific steps does the administration plan to take to promote
uptake and access for biosimilars in Medicare Part D?
Answer. HHS is committed to encouraging the use of biosimilar
biological products within the Secretary's scope of authority in order
to reduce costs to both beneficiaries and the Federal Government. In
general, however, a provision in the Part D statute prohibits the
Secretary of Health and Human Services from interfering with the
private negotiations between drug manufacturers and pharmacies and plan
sponsors, requiring a particular formulary, or instituting a price
structure for the reimbursement of covered Part D drugs. However, CMS
has the authority to review Part D plan formularies to ensure that drug
plans provide access to medically necessary treatments and do not
discriminate against any particular populations of beneficiaries. CMS
uses this authority to review plan formularies for appropriate
inclusion of all drug classes. HHS will continue using its authority
where possible to seek to promote competition, support increased
utilization of biosimilar and generic drugs, reduce the Federal
Government's spending on drugs, and achieve greater equity in drug
access and affordability for beneficiaries.
rural hospital stabilization pilot program
Question. HHS's Budget in Brief contains a single line item
identifying $20 million for a new Rural Hospital Stabilization Pilot
Program. The budget describes this proposed pilot program as both
providing assistance to rural hospitals at risk of closure and
supporting the expansion of hospital service lines that meet rural
communities' needs.
What are the detailed policy specifications for this new pilot
program, as well as corresponding cost estimates for each component of
the proposal?
Answer. As detailed in HHS's Health Resources and Services
Administration's Congressional Justification for the Fiscal Year 2024
Budget proposal, the $20 million requested to establish the Rural
Hospital Stabilization Pilot Program would enable HRSA to help
approximately 25 rural at-risk hospitals each year to expand their
services to create new care in the community while expanding revenue
streams to stabilize operations and meet local needs.
Specifically, this program would take actions such as:
Producing market assessments of participating hospitals to
assess gaps in services and those clinical areas where
expansion would meet local need and generate additional service
volume to improve financial operations; and
Helping rural hospitals identify and move into services
areas that are linked to broader public health needs such as
behavioral health, maternity care and those services that could
help rural hospitals reduce disparities.
temporary assistance for needy families
Question. The Temporary Assistance for Needy Families (TANF)
program allows States to support programs that promote independence and
economic self-sufficiency for low-income families. Unfortunately, TANF
has made headlines in recent years due to a lack of accountability and
rampant misuse of funds in the program.
The President's budget proposes to include new statutory authority
to collect more comprehensive TANF data and to develop an improper
payment rate for the program. While this step is necessary to improve
program integrity, more must to be done to ensure that TANF continues
to successfully lift families out of poverty.
What actions has the Department taken to reduce fraud in the TANF
program?
How does the administration plan to engage with Congress to ensure
that weaknesses can be addressed in the TANF program?
Answer. The Administration for Children and Families (ACF) is
committed to an effective safety net system that ensures funds are
spent to achieve their intended purpose and welcomes the opportunity to
work with Congress to strengthen TANF. TANF is intended to serve as a
critical support to families experiencing economic hardships, providing
cash assistance, employment and training assistance, and related
services to ensure families can meet basic needs, get access to
opportunities in the job market, and remain together.
ACF takes all allegations of fraud and misuse very seriously, as we
understand the vital importance of safeguarding taxpayer funds. ACF is
working on a number of areas to reduce fraud and strengthen TANF
program integrity. The agency proposed new statutory authority,
included in the President's FY 2024 budget, that would allow TANF to
collect information from States needed to calculate and report an
improper payment estimate, identify root causes of improper payments,
and develop and monitor corrective actions. In the absence of authority
to collect additional data, ACF is exploring the use of existing data
sources to strengthen TANF program monitoring and oversight, and we are
committed to working with Congress to provide programmatic insight in
this area. Additionally, ACF is working to ensure that auditors have
the information they need to assess if States have complied with
program requirements for areas including allowable costs and sub-
recipient monitoring, and to identify areas where States may need
additional supports and technical assistance to remediate any
weaknesses in internal controls.
The President's budget also notes that the Administration for
Children and Families (ACF) ``plans to propose a regulation to
strengthen TANF as a safety net, make changes to allowable uses of TANF
funds, and reduce administrative burden.''
The President's budget also notes that the Administration for
Children and Families (ACF) ``plans to propose a regulation to
strengthen TANF as a safety net, make changes to allowable uses of TANF
funds, and reduce administrative burden.''
Question. What details can you provide about this proposal, and
what timeline is ACF working towards to propose the regulation?
Answer. ACF plans to issue a proposed rule to strengthen the TANF
program as safety net and work preparation program, make changes to
provide additional definitions to allowable uses of TANF funds and
reduce administrative burden. The proposed rule will create additional
accountability for States to realign their TANF programs to support
those who need it most, and build programs centered around what we know
works best for families, while maintaining State flexibility and
remaining bound by the ways Congress intended for the program to
operate. These changes are intended to strengthen TANF to provide the
economic and workforce supports to those families and communities with
the greatest needs. Under the Workforce Innovation and Opportunity Act
(WIOA), except in States whose Governor opted out, TANF is a required
partner to WIOA-authorized labor/workforce programs funded by the
Departments of Labor and Education.
ACF is currently engaging in listening sessions to ensure a
proposed rule is intentional, impactful, and carefully crafted. ACF
looks forward to sharing a more concrete timeline once the listening
sessions have concluded.
kinship navigator programs
Question. Kinship navigator programs are critical to ensuring that
kin caregivers and their families are well supported, regardless of
their involvement in the child welfare system.
A recent report published by the Government Accountability Office
(GAO) noted that, as of December 2022, States have not yet accessed
Federal matching funds for evidence-based kinship navigator programs
due to various challenges in understanding or meeting the evidence-
based requirements for evaluating program outcomes. The GAO report
noted that HHS officials recognize that more time and resources may be
needed to allow for more research on kinship navigator programs to be
completed.
What does HHS consider to be an appropriate time frame for States
to build evidence supporting the effectiveness of kinship navigator
programs?
Answer. We agree that kinship navigator programs are critical
supports for kin caregivers and their families. We are pleased that we
are making progress in identifying models that are able to be rated as
promising or supported by the Prevention Services Clearinghouse, making
them available for use by title IV-E agencies under the title IV-E
Kinship Navigator program. As of the date of the hearing, seven kinship
navigator programs have been reviewed by the Prevention Services
Clearinghouse; one of these has been rated as supported and two of
these have been rated as promising. Building evidence can be time and
resource intensive. Evaluations can take multiple years to plan for and
conduct and then often take additional time to ensure findings are
disseminated. The timeline for completing evaluations is dependent on a
variety of factors including but not limited to funding, evaluation
design and sample, and data collection challenges. The funding provided
by Congress through annual appropriations under title IV-B, subpart 2
to support the development, enhancement, or evaluation of kinship
navigator programs is providing critical resources to assist a number
of title IV-E agencies to carry out rigorous evaluations. ACF is also
supporting evidence-building through the Notice of Funding Opportunity
(NOFO) issued in 2021 for Family Connection Grants: Building the
Evidence for Kinship Navigator Programs (HHS-2021-ACF-ACYF-CF-1903).
That NOFO estimated a 3-year grant period for evaluation. Therefore, we
hope that additional models will be able to be reviewed and rated over
the next several years.
______
Questions Submitted by Hon. Maria Cantwell
basic health program
Question. Between 2020 and 2022, 13.5 million additional adults
enrolled in Medicaid thanks to enhanced Federal matching subsidies and
other COVID-19 relief provisions. The Continuous Enrollment Provision
especially increased coverage stability for the most vulnerable
population and reduced costs for the government by preventing the
Medicaid ``churn.''
However, the Continuous Enrollment Provision is set to end after
this month. The Kaiser Foundation estimates that 5 to 14 million
Medicaid beneficiaries could lose coverage in the following months. In
addition, the generous Premium Tax Credit extension provided by the
Inflation Reduction Act is set to expire after 2025, and it is not
certain whether it will be extended again.
We must look for a long-term solution that could both reduce costs
for beneficiaries and the government, while ensuring that the most
vulnerable population continues to receive affordable, quality coverage
after the Public Health Emergency. I believe that the Basic Health
Program is the answer to these issues.
The Basic Health Program has produced tremendous results and
savings for the two States, New York and Minnesota, which have adopted
it. For example in New York, the BHP generated $1 billion in savings
for the State in 2019. Compared to benchmark silver plans, the 1
million New York BHP beneficiaries spent $719 million less in premium
and out-of-pocket costs. As of 2021, all New York BHP enrollees are
paying $0 in premiums. The program is so successful that the State is
pursuing a waiver to increase BHP eligibility from 200 percent of the
Federal Poverty Level to 250 percent of the Federal Poverty Level.
At the same time, the BHP provides coverage stability by capturing
those most susceptible to the Medicaid churn. This ensures that they
don't have a lapse in coverage or are subject to unnecessary
administrative procedures.
In your budget request, you proposed to make the enhanced Premium
Tax Credit permanent. This is projected to cost $183 billion over 10
years. Why do you think that this is the best method to lower health
insurance costs?
Do you think that the Basic Health Program could be a more cost-
effective alternative to making the expensive Premium Tax Credits
permanent?
As States begin to conduct Medicaid eligibility redeterminations
next month, we will need to ensure that those who no longer qualify for
Medicaid remain insured. How are you ensuring that those who no longer
qualify for Medicaid can continue to receive quality, affordable
coverage?
Do you believe that the Basic Health Program could be a good way to
fill the gap and increase coverage stability?
Last year, the Oregon and Kentucky State legislatures voted to
establish their own Basic Health Programs. West Virginia could be next.
This shows that States are exploring different options to reduce costs
and provide quality health insurance for their residents.
How can we incentivize more States to adopt the Basic Health
Program?
Will you work with me to encourage more States to adopt BHPs?
Answer. CMS is committed to using all the levers at our disposal to
expand access to high-quality, affordable care, and the President's FY
2024 budget includes a number of proposals that would support this
goal. For example, the budget proposes to permanently expand premium
tax credit eligibility by eliminating the required contribution for
individuals and families making 100 percent to 150 percent of the
poverty level and limiting the maximum income contributions towards
benchmark plans to 8.5 percent of income. Thanks to these subsidies,
for Open Enrollment 2023, four out of five people returning to
HealthCare.gov were able to find a plan for $10 or less after tax
credits.
CMS is also taking steps to make sure the country is prepared for
the end of the public health emergency on May 11th. For 2 years, CMS
has been working with all States to prepare for the unwinding of this
``continuous enrollment'' condition in order to ensure that as many
people as possible maintain health coverage. That includes helping
eligible individuals stay in Medicaid and CHIP, and helping others
transition to the Marketplaces, Medicare, or employer-sponsored
coverage. CMS is assessing States' compliance with Federal Medicaid
eligibility redetermination requirements and, where necessary,
developing strategies to address gaps or deficiencies.
CMS has implemented a multipronged approach to improve coverage
transitions, including a ramped-up outreach and marketing campaign, and
a variety of improvements to Federal marketplace policies and systems
to streamline the consumer experience, including a new Marketplace
Special Enrollment Period available now on HealthCare.gov for qualified
individuals and their families who are no longer eligible for Medicaid
or CHIP coverage.
This approach also includes enhanced consumer engagement for
consumers who lost or will soon lose Medicaid or CHIP coverage.
Navigators and other assistance personnel will maintain a critical
physical and virtual presence in communities across the U.S. to help
consumers understand basic concepts and rights related to health
coverage, provide enrollment assistance, and work with individuals to
link coverage to care. Specifically, CMS made a historic investment,
allocating a total of $100 million to Federal marketplace navigator
grantee organizations for the 2022-2023 budget period, including $12.5
million in support of additional direct outreach, education, and
enrollment activities for unwinding.
Continuing to expand access to coverage is essential, and I agree
there is a real opportunity with the Basic Health Program. CMS works
closely with States to identify innovative ways to expand access to
high-quality care while reducing health-care costs. I look forward to
continuing to work with Congress, and to hearing from any interested
States that want to try the program for themselves.
title x family planning
Question. The title X program provides essential reproductive
services like birth control, STI screenings, and preventative cancer
screenings. In 2021, it served about 1.7 million people, two-thirds of
whom were living under the Federal poverty level.
Investments in family planning are a proven way to keep people
healthy, improve families' financial security, and save taxpayers
money. In Washington State, there are over two dozen Planned Parenthood
centers that rely on sustained title X funding. Without these clinics,
thousands of people would not receive the health care they need.
Since the Supreme Court overturned the constitutional right to
abortion last year, access to contraception is more vital than ever.
Contraception cannot replace the need for abortion services, but it can
help prevent women from having to travel hundreds of miles out of State
for basic health care or an abortion.
Additionally, smaller and rural medical facilities are suffering
from post-pandemic financial strain and a lack of medical
professionals. As a result, some of them, including the Astria
Toppenish Hospital in my home State, have opted to close their
maternity wards. This is why programs like title X are more critical
than ever.
Title X has been funded levelly for the past 8 straight years. This
is unacceptable, especially as the program is working to rebuild from
the Trump administration's devastating domestic gag rule. Washington
State had to opt out of title X funding entirely due to the severity of
the domestic gag rule.
According to an American Journal of Public Health publication,
title X needs $737 million per year to provide family planning services
to uninsured, low-income women. The number of funding needs to be even
higher to account for other populations that rely on title X services.
Your Fiscal Year 2024 budget includes $512 million for title X. How
do you account for the difference between $512 million and the $737
million that researchers say is needed?
Answer. Title X funding remains critical for providing family
planning services that are equitable, affordable, client-centered, and
high-quality. The ability to access trusted, unbiased information is
even more important following the Dobbs v. Jackson Women's Health
Organization decision and the shifting legal landscape which has led to
confusion, misinformation, and disinformation. While data has not yet
been collected on the impact of the Supreme Court's ruling, title X
clinics have anecdotally reported experiencing an increased demand for
family planning services and, correspondingly, a need for additional
funding. The FY 2024 budget includes $512 million, a 79-percent
increase of the 2023 enacted level.
Question. I welcomed the Biden administration's decision to end the
title X domestic gag rule in 2021. Data showed that under the domestic
gag rule, title X went from serving 4 million patients in 2018 to 1.7
million patients in 2021. Has the program rebounded since the domestic
gag rule was overturned? How many patients did it serve in 2022?
Answer. The data is not yet available to assess the change in
services delivered and requested in 2022, but title X clinics have
anecdotally reported experiencing an increased demand for services
while combating the high turnover of key family planning staff.
Additionally, the title X program is still rebuilding its network of
clinics following the title X Final Rule and the restoration of funding
for clinics nationwide in Fiscal Year (FY) 2022. Once the Family
Planning Annual Report (FPAR) data is available in late summer of 2023,
HHS will assess the impact of the 2021 Final Rule.
home and community-based services
Question. Home and community-based services are extremely popular
in Washington State and across the country. I have worked with my
colleagues on both sides of the aisle to increase support for home and
community-based care. These services help millions of older adults and
people with disabilities avoid high-cost institutional care, while
letting them live in the comforts of a surrounding that they are
familiar with.
People with disabilities and older adults simply want the same
thing we all want--to live independently and age with dignity.
Furthermore, home and community-based care can cost as little as one-
third of the amount of nursing home care.
One successful program to support home and community-based services
is the Money Follows the Person program, which I have championed. This
program allows older adults and people with disabilities to leave
institutional care settings to live in their communities.
In Washington State, the Money Follows the Person program has been
incredibly successful, saving the State Medicaid program millions of
dollars. We must support efforts to have sustained funding for this
program so that States can effectively use these funds to expand the
program. We also need to do more to support caregivers, who offer
invaluable support and perform complex work. There are over 850,000
caregivers in Washington State, and the vast majority are unpaid,
female, and/or racial minorities.
While I am pleased that the Money Follows the Person program is
funded through Fiscal Year 2027 at $450 million per year, I have heard
that States are having difficulty planning for the program's future as
they are uncertain whether it will be reauthorized.
Do you think the current funding level is sufficient for each State
to operate a successful MFP program?
Do you recommend that the program receive permanent funding so that
States can better plan for the program in their budgets?
Answer. The Money Follows the Person (MFP) demonstration gives
beneficiaries more options for their care and allows them to choose to
receive care in the community, rather than institutions. Participating
States have demonstrated positive outcomes, including helping
individuals in institutions return to the community, improving
participant quality of life, and lowering the cost of care.
The budget proposes to invest $150 billion over 10 years in
Medicaid home and community-based services, enabling seniors and people
with disabilities to remain in their homes, to work, and stay active in
their communities. At the same time, the proposal promotes better
quality jobs for home-care workers and enhances supports for family
caregivers, many of whom are too often forced out of the workforce due
to the demands of caring for a loved one.
Question. Home and community-based services cannot exist without a
robust caregiving workforce. Home care workers are often low-income,
women, underpaid or unpaid, and overworked.
How would the budget support caregivers?
Do you have any plans to increase the availability of the
caregiving workforce while providing adequate compensation for these
workers?
Answer. The caregiving workforce that helps older adults and people
with disabilities live and participate in their communities is
comprised of the paid, direct-care workforce and unpaid family
caregivers; Within HHS, the Administration for Community Living (ACL)'s
budget request for FY 2024 seeks to strengthen both. With respect to
the paid direct-care workforce, HHS/ACL is currently funding the
development of a Direct Care Workforce Center (https://acl.gov/news-
and-events/announcements/acl-launches-national-center-strengthen-
direct-care-workforce) through which State, private, and Federal
entities involved in the recruitment, training and retention of direct-
care workers can access model policies, best practices, training
materials, technical assistance, and learning collaboratives. Funding
in FY 2024 will support continued operations of the Center and
establish demonstration grants to develop partnerships across State
aging, disability, Medicaid, and labor/workforce agencies and with
aging, disability, labor and provider stakeholders to implement
recruiting, retention, and training approaches to strengthen job
quality in the
direct-care workforce at State and local levels. The Direct Care
Workforce Center is designed to catalyze change at a systems level that
will address the insufficient supply of trained direct-care workers,
including Direct Support Professionals to assist individuals with
disabilities to become and stay employed and live in the community,
promote promising practices at all levels of the service system, and
improve data collection to enable a full understanding of the workforce
issue. The anticipated outcomes of this effort, include but are not
limited to:
Increasing the availability and visibility of tools and
resources to attract, train and retain the direct-care
workforce in quality jobs where they earn livable wages and
have a voice in their working environment and have access to
benefits and opportunities for advancement; and
Increasing the number of States that develop and sustain
collaborations across State systems and workforce agencies to
implement strategies that will improve the recruitment,
retention, and advancement of high-quality direct-care
workforce jobs.
Family caregivers often rely on direct-care workers to augment
their efforts to support and assist those for whom they provide care.
Over 53 million people are family caregivers, with a growing number of
people having to provide care or provide more care due to the direct-
care workforce crisis. To address the need for greater recognition,
inclusion and support of family caregivers, in September 2022 ACL, in
collaboration with the Family Caregiving Advisory Council, delivered to
Congress and the Nation the first National Strategy to Support Family
Caregivers (the Strategy) (https://www.hhs.gov/about/news/2022/09/21/
hhs-delivers-first-national-strategy-support-family-caregivers.html).
The strategy addresses five critical priorities areas associated
with supporting family caregivers, one of which (Outcome 3.9) addresses
the need for ``an agile, flexible, and well-trained direct-care
workforce . . . to partner with and support family caregivers.''
Additionally, the Strategy puts forth a series of ideas for action that
can be taken by multiple sectors to increase the availability and
viability of the direct-care work force.
ACL is beginning some initial steps to implement the Strategy,
including establishing technical assistance (https://www.grants.gov/
web/grants/search-grants.
html?keywords=caregiver) to curate best practices and model policies
and launching a project to help caregivers access services and
supports. Funding in FY 2024 will allow ACL to provide training and
technical assistance to the aging, tribal and kinship family caregiver
support networks and to establish demonstration grants to enable States
and local communities to test solutions and strategies identified in
the Strategy to support family caregivers, including by strengthening
the paid direct-care workforce and the partnership between that
workforce and family caregivers.
______
Questions Submitted by Hon. Robert Menendez
Question. Please explain the increased role title X plays following
the Dobbs decision and why it is such a critical part of supporting
women's reproductive health?
Answer. For over 50 years, title X family planning clinics have
played a significant role in ensuring access to reproductive and
preventive health-care services for millions of low-income or uninsured
individuals. Following the Dobbs decision, expanding and maintaining
access to contraception and family planning services under the title X
program has become more critical than ever. The shifting legal
landscape resulting from the Supreme Court's ruling has led to
confusion, misinformation, and disinformation--which has increased the
need for evidence-based and high-quality services and information. The
title X program supports high-
quality, family planning services and preventive care, including breast
and cervical cancer screening, contraceptive counseling and care,
sexually transmitted infection testing and treatment, and HIV
screening. While contraception and related title X-funded services
cannot replace the need for abortion, title X-funded clinics remain a
critical safety net and important access point for trusted, nonbiased
health-care services and information for many people in need of care.
Question. Please explain why title X funding is particularly
important to promoting health equity and racial and economic justice?
Answer. Advancing equity for all through the delivery of health-
care services is a priority for the title X family planning program.
The funding awarded to our vast network of providers and clinics
directly supports clients from low-income families, clients of color,
and others who have been historically underserved, marginalized, and
adversely affected by persistent poverty and inequality. Many of the
clients served through our network rely on title X providers for their
usual source of medical care, including a wide range of preventive
services. Moreover, recipients provide title X clients with access to
the same quality health care, including full medical information and
referrals, that higher-income clients and clients with private
insurance are able to access. And, the ability to access high-quality
contraception is an important part of helping ensure people can make
decisions about their own health, lives, and families. Title X funding
has historically been a critically important resource in promoting
health equity and racial and economic justice, and it remains a
critical source of care for those most in need.
Question. How is the administration ensuring that efforts to
address mental health challenges support LGBTQ youth and youth of
color?
Answer. Within the Department of Health and Human Services, the
Substance Abuse and Mental Health Services Administration (SAMHSA)
advances efforts to reduce disparities in mental and/or substance use
disorders across populations, including LGBTQI+ youth and youth of
color.
The Biden-Harris administration is committed to addressing mental
health challenges impacting LGBTQI+ youth in several ways--all of which
are grounded in advancing Executive Order 14075 (Advancing Equality for
Lesbian, Gay, Bisexual, Transgender, Queer, and Intersex Individuals).
SAMHSA is promoting family counseling and support of LGBTQI+ youth by
including language in relevant notices of funding opportunities, such
as the School-Based Trauma-Informed Support Services and Mental Health
Care for Children and Youth program, allowing grantees to provide
trauma-informed evidence-based counseling and support services for
LGBTQI+ children, adolescents, and their families/caregivers. In
addition, SAMHSA began the ``press 3'' LGBTQI+ youth pilot for LGBTQI+
youth who contact the 988 Suicide and Crisis Lifeline last fall.
Currently, 18 percent of texts, 15 percent of chats and 6 percent of
calls routed within 988 are for the LGBTQI+ youth-specialized services.
Furthermore, SAMHSA supports the LGBTQI+ Behavioral Health Equity
Center of Excellence, which provides behavioral health practitioners
with vital information on supporting this population.
To address mental health challenges for people of color, SAMHSA
administers a number of Centers of Excellence. This includes the Asian
American, Native Hawaiian, and Pacific Islander Center of Excellence
(AANHPI-CoE). The AANHPI-CoE is tasked with developing and
disseminating culturally informed, evidence-based behavioral health
information and providing technical assistance on training on issues
related to addressing behavioral health disparities in the Asian
American, Native Hawaiian, and Pacific Islander communities.
SAMHSA also funds the Centers of Excellence for Behavioral Health
Disparities, which establishes three Centers of Excellence to develop
and disseminate training and technical assistance for health-care
practitioners on issues related to addressing behavioral health
disparities. It is expected that the recipients will implement training
and technical assistance for practitioners to address the disparities
in behavioral health care in three key populations: African Americans,
LGBTQ, and the aging population. Additionally, African American
Behavioral Health Center of Excellence is a new national Center whose
academic home is the National Center for Primary Care, Morehouse School
of Medicine. The goal of this Center is to help the field transform
behavioral health services for African Americans, making them: Safer,
More effective, More accessible, More inclusive, More welcoming, More
engaging, and More culturally appropriate and responsive!
In addition to these Centers of Excellence, SAMHSA aims to increase
the diversity in the behavioral health workforce through the Minority
Fellowship Program, which provides stipends to increase the number of
culturally competent behavioral health professionals who teach,
administer, conduct services research, and provide direct mental
illness or substance use disorder treatment services for minority
populations that are underserved.
Further, the following SAMHSA grant programs include a focus on
youth and young adults with co-occurring conditions and have helped
ameliorate some of the gaps in access to care that youth with mental
health challenges face: The Infant and Early Childhood Mental Health
program (IECMH), Children's Mental Health Initiative (CHMI), the Mental
Health Block Grant, the Family Support Technical Assistance Center, and
the Statewide Family Network.
Finally, for youth suffering from mental illness or a co-occurring
disorder in the juvenile justice system, SAMHSA also operates a grant
program to establish or expand programs that divert these youth from
the criminal justice system into treatment when it is safe to do so.
The Behavioral Health Partnership for Early Diversion of Adults and
Youth program supports grantees who provide community-based mental
health and substance use disorder services and other supports prior to
arrest and booking.
Question. The 988 suicide and crisis line currently provide live
crisis center calling services in English and Spanish and uses Language
Line Solutions to provide translation services in over 250 additional
languages. But, text and chat services are currently only available in
English. What are the agency's plans to improve language access to the
lifeline?
Answer. The SAMHSA-administered 988 Suicide and Crisis Lifeline
plans to add Spanish chat and text services by the end of FY 2023 and
is focused on supporting the Spanish crisis center workforce with
trainings and webinars conducted in Spanish. SAMHSA also is working to
launch video-phone services for individuals who are deaf or hard of
hearing and might prefer to interact with 988 in that manner.
The 988 Lifeline currently provides live crisis center calling
services in English and Spanish. Further, the 988 Lifeline increased
the number of call centers dedicated to taking Spanish calls in 2022.
The 988 Spanish subnetwork has seen both an increase in calls along
with improvement in response rates (45 percent answered volume increase
over previous year). The Spanish call line improved response rates
across States and territories from 63 percent in July to 84 percent in
March 2023.
The 988 Lifeline also offers crisis services interpreted into over
240 languages and dialects through the call option to 988, increasing
accessibility to many people wishing to use the line. Interpreting
services are available 24/7 and the average time to be connected to an
interpreter is only 17 seconds. The 988 interpreting service allows
callers to comfortably connect with crisis counselors in their
preferred language outside of English. To connect with an interpreter,
callers can dial 988 and ask for an interpreter in English if they are
able, or they can simply say the name of the language they need to
prompt the crisis counselor to get an interpreter on the line. The 988
interpreting service can also assist crisis counselors in identifying
the needed language if the crisis counselor is unsure. Interpreters
receive special training to provide effective interpretation over the
telephone and follow a code of ethics that includes requirements
related to confidentiality, accuracy, and impartiality. Interpretation
is only available through calling 988, it is not yet available for 988
text and chat services. SAMHSA is monitoring utilization of Language
Line services to understand the demand for live crisis calling services
in languages other than English and assess future workforce needs.
______
Questions Submitted by Hon. Thomas R. Carper
addressing sdoh
Question. The social drivers of health contribute to more than 80
percent of an individual's health status and have a particularly
profound impact on children. Addressing social drivers early in
childhood could help reduce avoidable health-care costs across the life
span and improve the health of our future generations.
In the FY 2023 omnibus bill, report language related to Whole Child
Health Demonstration models was included, which asked the Centers for
Medicaid and CHIP Services (CMCS) to provide a report within 180 days
to congressional committees containing its plan to design a Whole Child
Health demonstration program. Could you provide a status update on that
report?
Answer. HHS agrees that addressing the Social Determinants of
Health (SDOH, which we are beginning to refer to as Social Drivers of
Health to acknowledge that SDOH conditions can be mitigated to improve
outcomes) is very important for the health and well-being of the Nation
and that addressing SDOH requires engagement and coordination across
HHS, as well as with other departments within the Federal Government.
HHS is committed to advancing health equity, expanding coverage,
and improving health outcomes for the millions of Americans covered by
our programs, including the children enrolled in Medicaid and CHIP. In
2021, CMS released a letter to State Health Officials, entitled
``Opportunities in Medicaid and CHIP to Address Social Determinants of
Health (SDOH)'', to describe opportunities under Medicaid and CHIP to
better address SDOH and to support States with designing programs,
benefits, and services that can more effectively improve population
health, reduce disability, and lower overall health-care costs in the
Medicaid and CHIP programs by addressing SDOH.\43\ Further, in 2023,
CMS began to offer a new Medicaid section 1115 demonstration
opportunity to support States in addressing health-related social needs
(HRSN), with the goals of improving coverage, access, and health equity
across Medicaid beneficiaries. HRSN are an individual's unmet, adverse
social conditions that contribute to poor health and an individual's
HRSN are a result of their community's underlying SDOH.\44\
---------------------------------------------------------------------------
\43\ https://www.medicaid.gov/federal-policy-guidance/downloads/
sho21001.pdf.
\44\ https://www.medicaid.gov/medicaid/downloads/addrss-hlth-soc-
needs-1115-demo-all-st-call-12062022.pdf.
I look forward to hearing from you and from stakeholders across the
health-care spectrum as we examine ways to build health equity into new
and existing efforts.
mental health services
Question. Medicaid and CHIP cover over 40 million children.
Therefore, Medicaid and CHIP investments in access to needed mental
health services are critical to addressing the national children's
mental health emergency.
What are you proposing in your budget to specifically address
children's mental health challenges under Medicaid and CHIP?
Answer. The budget provides historic investments in the behavioral
health workforce, youth mental health treatment, Certified Community
Based Behavioral Health Clinics, Community Mental Health Centers, and
mental health research. The budget strengthens access to crisis
services by investing in the 988 Suicide and Crisis Lifeline to address
100 percent of estimated contacts, scaling follow-up crisis services,
and expanding CDC's suicide prevention program to all States, the
District of Columbia, and 18 Tribal and territorial jurisdictions. To
address the mental health crisis among adolescents, the budget expands
CDC's What Works in Schools program to up to 75 of the largest local
education agencies. The budget also accelerates mental health research
for promising new treatments and enhanced precision and implementation
of existing treatments.
Within Medicaid and CHIP, the administration has taken a number of
steps to increase access to children's mental health-care services. On
August 18, 2022, CMS issued guidance to remind States about Medicaid's
Early and Periodic Screening, Diagnostic and Treatment requirements for
most Medicaid beneficiaries under age 21, including in the provision of
behavioral health services.\45\ The guidance also includes examples of
ways that Medicaid and CHIP funding, alone or in tandem with funding
from other HHS programs, can be used in the provision of high-quality
behavioral health services to children and youth. On that same day, CMS
released additional guidance encouraging States to work with schools to
deliver on-site health-care services, including behavioral health
services, to children enrolled in the Medicaid program.\46\
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\45\ https://www.medicaid.gov/federal-policy-guidance/downloads/
bhccib08182022.pdf.
\46\ https://www.medicaid.gov/federal-policy-guidance/downloads/
sbscib081820222.pdf.
CMS is also working with States to increase access to behavioral
health-care services within schools. In addition to implementing new
Medicaid school-based service initiatives made possible by the
Bipartisan Safer Communities Act, CMS updated guidance on Medicaid
claiming for school-based administrative services and costs;
established a technical assistance center in collaboration with the
Department of Education to help States advance Medicaid coverage of
school-based health services including mental health and substance use
disorder services; and awarded $50 million in grants to States to help
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improve Medicaid coverage of school-based services.
CMS has taken a multifaceted approach to increase access to
equitable behavioral health services and improve outcomes for people
covered by Medicare, Medicaid, CHIP, and private health insurance,
including efforts through the Connecting Kids to Coverage National
Campaign. Campaign resources focused on mental health are available on
InsureKidsNow.gov for organizations to use in their outreach, including
short digital videos, live reads, social media messages, graphics,
newsletter templates, and more.
In addition, CMS has been working with States to ensure CHIP
programs cover services to prevent, diagnose, and treat a broad range
of behavioral health symptoms and disorders consistent with SUPPORT Act
requirements. CMS works closely with States to implement mental health
and substance use disorder parity requirements in CHIP and Medicaid--
critical to making sure kids with behavioral health conditions have
access to the care they need.
Lastly, in January 2022, CMS launched the 5-year implementation
period of the Integrated Care for Kids Model to improve the quality of
care for children under 21 years of age covered by Medicaid through
prevention, early identification, and treatment of behavioral and
physical health needs.\47\
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\47\ https://innovation.cms.gov/innovation-models/integrated-care-
for-kids-model.
______
Questions Submitted by Hon. Benjamin L. Cardin
medically necessary dental care
Question. In December 2022, the Centers for Medicare and Medicaid
Services (CMS) Medicare Physician Fee Schedule final rule clarified
Medicare coverage of medically necessary dental services. I applaud the
agency for heeding the call from me and my colleagues by taking this
much needed action to improve the health and well-being of Medicare
beneficiaries.
When CMS issued the rule, it established a very specific definition
in clarifying covered dental services: ``dental services that are
inextricably linked to, and substantially related and integral to the
clinical success of, a certain covered medical service.'' The agency
also listed specific services covered under this definition, including,
but not limited to, certain services ``prior to Medicare-covered organ
transplant, cardiac valve replacement, or valvuloplasty procedures,''
and certain services ``performed as a result of and at the same time as
the surgical removal of a tumor.''
As CMS implements this policy, the agency identified numerous
aspects that would require additional guidance. I would appreciate an
update from the agency on its plans and timeline with respect to
guidance covering the following issues.
In the final rule, CMS stated that it may issue guidance to clarify
that CMS Medicare Administrative Contractors ``may make claim-by-claim
determinations, as necessary.'' Does CMS plan to issue such guidance
and, if so, when does the agency anticipate the guidance will be
available?
Further, CMS stated that ``integration between the medical and
dental professional,'' would be necessary for Medicare payment. Does
CMS plan to issue guidance clarifying requirements with respect to
medical and dental integration and, if so, when does the agency
anticipate releasing the guidance?
CMS also stated that dentists ``would need to be enrolled in
Medicare and meet all other requirements for billing'' under the
Medicare Physician Fee Schedule, and indicated it would ``work to
provide additional guidance to answer enrollment, billing, compliance,
and other administrative questions for dentists as needed.'' Does CMS
intend to provide education and guidance to ensure dentists are aware
of enrollment and other requirements so they can meet the needs of
their Medicare patients? If so, when would this guidance and
educational effort begin?
CMS stated it will ``make updates to appropriate Medicare payment
data files to ensure that appropriate payments can be made under the
applicable payment system'' for covered services. Will CMS provide
guidance to dentists on payment policies and payment mechanisms, which
would be new for dentists who have are not enrolled in Medicare? If so,
when would this information be made available?
CMS acknowledged outstanding questions about multiple issues,
including: the claims form ``dentists would use to submit claims for
dental services''; the ``procedure code set and diagnostic codes that
would be reflected on claims''; whether ``National Coverage
Determinations (NCDs) will be issued to ensure consistent claim
payment''; requirements regarding ``frequency limits, documentation
requirements, and authorization processes''; and ``Medicare enrollment
processes for dentists.''
The agency cited ``the need to address and clarify certain
operational issues,'' and stated it is working to address these issues,
including efforts to adopt the dental claim form. CMS stated it plans
to provide further guidance on these issues. Can you provide additional
details on the process and timeline for issuing this guidance?
Answer. Medicare payment for dental services is generally precluded
by statute. However, Medicare has allowed payment for dental services
in a limited number of circumstances, specifically when that service is
an integral part of specific treatment of a beneficiary's primary
medical condition. Some examples include reconstruction of the jaw
following fracture or injury, tooth extractions done in preparation for
radiation treatment for cancer involving the jaw, or oral exams
preceding kidney transplantation.
CMS's Calendar Year 2023 Medicare Physician Fee Schedule final rule
clarified and codified certain aspects of the current Medicare payment
policies for dental services when that service is an integral part of
specific treatment of a beneficiary's primary medical condition and
outlined other clinical scenarios under which Medicare payment can be
made for dental services, such as dental exams and necessary treatments
prior to, or contemporaneously with, organ transplants, cardiac valve
replacements, and valvuloplasty procedures. Looking ahead to 2024, CMS
will begin paying for dental exams and necessary treatments prior to
the treatment for head and neck cancers starting in 2024.
Finally, CMS finalized a process to review and consider public
recommendations for Medicare payment for dental services in other
clinical scenarios. Dentists, as appropriate, can continue to enroll in
Medicare according to the current process. Dentists and other qualified
practitioners who furnish dental services that are eligible for payment
under Parts A and B (because they are inextricably linked to another
Medicare-covered medical service) should continue to submit claims
using current processes, and can consult with their Medicare
Administrative Contractors (MACs) for specific claims submission
questions.
As noted in the CY 2023 Physician Fee Schedule final rule, CMS
acknowledges the need to address and clarify certain operational
issues, and is working to address these issues. CMS anticipates
resolving many of the additional operational issues raised by
commenters potentially as soon as CY 2024, including efforts to adopt
the dental claim form and will also make updates to appropriate
Medicare payment data files to ensure that covered dental services can
be billed and paid based on the applicable payment system for services
furnished. CMS continues to work with the MACs and encourages continued
feedback from interested parties to help identify concerns or questions
regarding submission and processing of dental claims. CMS also plans to
provide guidance and engage in further rulemaking, as necessary, as
operational strategies and plans are refined and implemented and will
also monitor service utilization to identify any concerns about
consistency of claims processing and adequacy of access across the
country.
CMS appreciates the feedback and engagement from members of
Congress and stakeholders in the dental community during the CY 2023
rulemaking process and looks forward to continuing that engagement as
CMS implements this new policy.
nimhd and health disparities
Question. On President Biden's first day in office, he signed an
executive order directing a whole government approach to addressing
racial equity and disparities among underserved communities. The
President built on that through an additional executive order last
month. I applaud his focus on this critical issue. Racial and ethnic
minority populations experience higher rates of illness and death from
health conditions such as cancer, diabetes, HIV/AIDS, mental health,
and obesity.
That is why I have championed legislation throughout my time in
Congress to highlight health disparities. In particular, I authored the
provision in the Affordable Care Act that elevation of the National
Center on Minority Health and Health Disparities to that of an
Institute at the National Institutes of Health (NIH). Now known as the
National Institute on Minority Health and Health Disparities, NIMHD
does critical work to address health disparities. I thank the
administration for prioritizing these efforts through previous
increases in their funding.
Can you comment on how NIMHD is coordinating health disparities
research across NIH?
How is the administration working to ensure eliminating health
disparities is a focus of and funded through all Institutes within NIH
and across HHS?
Answer. NIH is committed to conducting and supporting scientific
research to improve minority health and reduce health disparities.
NIMHD led an agency-wide workgroup culminating in the development and
publication of the NIH Minority Health and Health Disparities Strategic
Plan (2021-2025) (referred to in this response as the ``Strategic
Plan'').\48\ The Strategic Plan, which aligns with the NIH-Wide
Strategic Plan for Diversity, Equity, Inclusion, and Accessibility,\49\
represents a commitment by all of NIH to advance knowledge in three
core areas: (1) science of minority health and health disparities, (2)
research-sustaining activities, such as training and capacity building,
and (3) outreach, collaboration, and dissemination. Following the
Strategic Plan's release, NIMHD is leading NIH Institutes, Centers, and
Offices (ICOs) to examine progress toward meeting the goals outlined in
the Strategic Plan. NIMHD has established an NIH-wide working group
that will be evaluating the progress made on the Strategic Plan,
identifying gaps to address by 2025, and laying the foundation for the
Strategic plan for 2026 to 2030. The working group will develop metrics
and a data collection system to track the alignment of activities
related to minority health and health disparities with the Strategic
Plan priorities.
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\48\ https://nimhd.nih.gov/about/strategic-plan/.
\49\ https://www.nih.gov/sites/default/files/about-nih/nih-wide-
strategic-plan-deia-fy23-27.pdf.
NIMHD works with NIH ICOs to collectively invest in, integrate, and
prioritize health disparities as a topic of interest through
collaborative research initiatives, programs, and other activities. For
example, the Community Engagement Alliance (CEAL) Against COVID-19
Disparities and the Rapid Acceleration of Diagnostics for Underserved
Populations (RADx-UP) are two initiatives that focus on populations
disproportionately impacted by the pandemic. Co-led by NIMHD and the
National Heart, Lung, and Blood Institute, the CEAL Initiative actively
works in communities in 21 States around the United States and its
territories to build trusting relationships and share science-based
information. The initiative supports community-engagement activities to
address questions about COVID-19 vaccination, therapeutics, and
participation in clinical trials among those disproportionately
affected by the pandemic. Since its inception, CEAL has recruited over
950 partners across the United States and Puerto Rico, supported over
1,500 local events reaching more than half a million participants,
delivered COVID-19 vaccines to around 200,000 people, and enrolled over
600 people to participate in COVID-19-related clinical trials. The CEAL
Network is well-positioned to address other critical health disparities
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in the coming years.
The RADx-UP Initiative is an NIH effort that comprises a consortium
of 137
community-engaged projects across the United States, its territories,
as well as Tribal Nations to assess and expand COVID-19 testing to
communities disproportionately affected by the COVID-19 pandemic. In
November 2022, the RADx-UP initiative and NIMHD published a special
issue in the American Journal of Public Health highlighting peer-
reviewed research on interventions to promote testing for SARS-CoV-2,
studies on social, behavioral, and ethical issues of the pandemic in
underserved populations, and commentaries by NIH leadership on the
significance of the initiative.\50\ The publication informs and
prioritizes key strategies and responses for future public health
responses among communities experiencing health disparities. RADx-UP is
currently in its final phase of supporting research for improving
COVID-19 testing interventions to decrease infections,
hospitalizations, and mortality among populations experiencing health
disparities.
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\50\ https://pubmed.ncbi.nlm.nih.gov/36265091/; https://
pubmed.ncbi.nlm.nih.gov/36265090/; https://pubmed.ncbi.nlm.nih.gov/
36194852/.
In FY 2021, NIMHD launched the Structural Racism and Discrimination
initiative to understand and address the impacts of structural racism
and discrimination on minority health and health disparities. The
initiative funded 38 R01 observational and intervention research
projects across 14 NIH Institutes. Research findings will provide
important insights that can help address the underlying causes of
structural racism, discrimination, and social determinants of health to
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reduce health disparities.
The NIH Common Fund launched the Community Partnerships to Advance
Science for Society (ComPASS) program to support innovative structural
intervention projects that focus on social determinants of health for
community-empowered research. The program will enable communities and
researchers to work collaboratively as equal partners in all phases of
the research process to enhance the quality of interventions and
advance health disparities research.
The ComPASS program intends to improve health outcomes in
communities affected by health disparities and inform social policies,
systems, and practices to achieve optimal health for all. NIMHD, the
National Institute of Nursing Research (NINR), the National Institute
of Mental Health, and the NIH Office of Research on Women's Health,
serve as co-chairs of the ComPASS working group that directs major
ComPASS activities and funding actions.
In efforts to better understand the impact of structural racism and
discrimination in causing and sustaining health disparities, NIMHD,
NINR, the National Institute of Diabetes and Digestive and Kidney
Diseases, and the NIH Office of Disease Prevention released a funding
opportunity for community-engaged intervention research to address
structural racism to reduce health disparities among individuals living
with kidney disease.\51\
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\51\ https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-23-
003.html
In addition to these select research activities and efforts, NIMHD
remains committed to working with HHS partners to ensure that the
elimination of health disparities remains a priority within NIH and
across the HHS.
telehealth
Question. The last 3 years have shown the benefits of telehealth
services. I have been proud to partner with bipartisan colleagues to
protect access to telehealth through initiatives, including the CONNECT
for Health Act and my work with Senator Thune last Congress in the
Senate Finance Committee on tele-mental health.
Together, we secured an extension of telehealth flexibilities until
the end of 2024, allowing your department and Congress to continue to
ensure the appropriate flexibilities are made permanent.
I want to thank you for working with us throughout the COVID-19
pandemic to make telehealth accessible and predictable for those who
came to rely on it. Still, we have seen disparities in access and
quality of care.
How is the administration proactively addressing these disparities
and ensuring equitable access to high-quality care?
As HHS winds down the Public Health Emergency (PHE) and we look
towards permanent telehealth policies, how is HHS ensuring the
collection of appropriate data to identify and prevent disparities in
access to telehealth across department programs?
How is HHS ensuring that Transformed Medical Statistical
Information System (T-MSIS) data is complete and high quality in order
to better assess telehealth modalities that have been rapidly deployed
during the pandemic.
Answer. In response to the COVID-19 public health emergency, which
is set to expire in May 2023, flexibilities for Medicare telehealth
services were issued through legislative and regulatory authorities to
increase access to care for patients and providers. The Consolidated
Appropriations Act of 2023 recently extended many of these
flexibilities through December 31, 2024. Extended telehealth
flexibilities include waiving geographic and site of service
originating site restrictions so that Medicare patients can continue to
use telehealth services from their home and allowing audio-only
telehealth services. Additionally, the expanded list of providers
eligible to deliver telehealth services is also extended so Medicare
beneficiaries can continue to receive telehealth services furnished by
physical therapists, occupational therapists, speech language
pathologists, and audiologists, as well as receive telehealth services
from Rural Health Clinics and Federally Qualified Health Centers
through December 31, 2024. If you are interested in drafting
legislation to make these waivers permanent, CMS would be happy to
provide technical assistance.
Additionally, recent legislative and regulatory changes made
several telehealth flexibilities permanent. Federally Qualified Health
Centers and Rural Health Clinics can furnish certain behavioral and
mental health services via telecommunications technology. Medicare
patients can continue to receive these telehealth services in their
home as geographic restrictions on the originating site are eliminated
for these telehealth services. Certain mental telehealth services can
be delivered using audio-only communication platforms, and rural
emergency hospitals can serve as an originating site for telehealth
services.
CMS would be happy to provide technical assistance on legislation
to make these waivers permanent or any other legislation you have to
expand access to telehealth.
Data about Medicare fee-for-service beneficiaries who used
telehealth services between January 1, 2020 and September 30, 2022, and
a Medicare telehealth trends report, are available at https://
data.cms.gov/summary-statistics-on-use-and-payments/medicare-service-
type-reports/medicare-telehealth-trends. The data will be updated
quarterly.
For Medicaid and CHIP, telehealth flexibilities are not tied to the
end of the PHE and have been offered by many State Medicaid programs
long before the pandemic. Medicaid and CHIP telehealth policies will
ultimately vary by State. CMS encourages States to continue to cover
Medicaid and CHIP services when they are delivered via telehealth.
Furthermore, The Health Resources and Services Administration
(HRSA) supports the telehealth efforts of the Department of Health and
Human Services (HHS) to expand access and improve health outcomes. In
particular, HRSA's telehealth programs promote and advance telehealth
services in rural and underserved areas. HHS oversees
Telehealth.HHS.gov, which is a one-stop resource for patients,
providers, and States for information about telehealth such as
telehealth best practices, policy and reimbursement updates, funding
opportunities, and more.
In addition, from September 1, 2021 to August 31, 2022, HRSA's
Telehealth Resource Centers provided responses to over 6,000 technical
assistance requests to assist providers with implementing telehealth
and understanding evolving telehealth policy. Further, HRSA's
Telehealth Network Grant Program for emergency services promotes rural
tele-emergency services by enhancing telehealth networks to deliver 24-
hour Emergency Department consultation services via telehealth to rural
providers without emergency care specialists. In the most recent
reporting cycle, this program served approximately 13,000 patients.
HRSA's Licensure Portability Grant program is another key resource
for increasing access to health-care services. It provides support for
State professional licensing boards to work together to reduce the
burden on clinicians who provide telehealth services in multiple
States. Through this program, the Federation of State Medical Boards
developed the Provider Bridge to make it easier for professionals to
practice across State lines. Over 145,000 providers registered to use
the platform.
The FY 2024 budget request would enable HRSA to continue the HHS
Telehealth Hub, support the Telehealth Resource Center Program, fund
Telehealth Network Grant Program awards, and recompete the Licensure
Portability Grant program, among other efforts to proactively address
disparities in access and quality of care.
To identify and prevent disparities in access to telehealth, the
budget request would help HRSA to track funding, projects, and data for
telehealth services and provide a systematic way of capturing data from
programs and activities within HRSA's Office for the Advancement of
Telehealth that could help inform overall performance of award
recipients and their outcomes.
health systems strengthening
Question. The President's budget includes significant resources to
prepare for future pandemics, including bolstering the surveillance,
laboratory, and public health workforce capacities of the U.S. Centers
for Disease Control and Prevention (CDC).
The CDC has been clear that a disease threat anywhere in the world
is a disease threat everywhere in the world. To that end, the CDC has
routinely exchanged scientific expertise and data with other nations,
worked alongside other agencies, such as the U.S. Agency for
International Development and the State Department, to help strengthen
health systems and workforces abroad.
How will investments from the FY24 budget allow the Department of
Health and Human Services to contribute to global health systems
strengthening as a critical component of pandemic preparedness and
global health security?
Answer. As the United States' lead public health agency with
decades of experience responding to infectious disease threats, CDC
works 24/7 to protect the health and safety of Americans. CDC works on
behalf of the American people to save lives around the world,
partnering with other nations to prevent, prepare for, and respond to
infectious disease threats.
CDC is uniquely suited to use its expertise to support partner
governments in building health programs, address health threats,
enhance sustainable and country-owned public health systems, and
improve health outcomes for all. CDC experts work alongside local,
regional, and global partners across their global health portfolio to
provide unparalleled expertise in data analytics, disease and vector
surveillance, diagnostics, laboratory systems, workforce development,
emergency preparedness, and outbreak response.
CDC's global health security efforts help detect and contain
outbreaks quickly, before they spread, cause deaths, and disrupt the
economy. The most effective and least expensive way to protect
Americans from diseases and other health threats that begin overseas is
to prevent, detect, and respond to outbreaks before they spread to the
United States.
In FY 2024, with additional funding requested in the FY 2024
budget, CDC will continue to:
Build a strong cadre of international disease detectives
through expanded education in surveillance, leadership and
management, and emergency response through the Field
Epidemiology Training Program (FETP). Helping countries to
build up their own robust and self-sufficient public health
workforce capable of rapidly handling outbreaks within their
region is the foundation for sustainable long-term global
health security.
Work side-by-side with countries and partners to strengthen
global public health systems, including developing disease
surveillance systems that enable disease detection, tracking
and reporting, as well as helping to build more effective
public health laboratories, both of which can be leveraged to
respond to new and emerging threats globally to contain spread.
Invest in the public health systems needed for HIV testing,
prevention, and control. CDC's HIV-focused investments not only
build the foundations for an efficient, sustainable,
accountable, and high-impact response to HIV, but also, CDC's
unique approach to implementing global HIV programs create
platforms that play an essential role in the global response to
COVID-19 and many other emerging and re-emerging public health
threats.
Build capacity through collaborations with countries
experiencing the highest burden of vaccine-preventable diseases
to achieve sustainability of their own immunization programs
and surveillance systems.
Help countries establish public health emergency management
programs and Emergency Operation Centers (EOCs) to prepare for,
respond to, contain, and recover from public health threats.
With additional resources, CDC will scale and adapt its
emergency management technical assistance to provide more
support across regions and to countries at their national and
sub-national levels.
Enhance workforce training, research and diagnostic
development, and innovative approaches to surveillance and
early detection for rapid outbreak response across areas such
as antimicrobial resistance, food and water-borne diseases,
high consequence pathogens (viral hemorrhagic fevers, anthrax,
etc.) and vector-borne diseases.
Ensure the access to vaccines for influenza and meningitis
and maintain the primary global resource of respiratory
laboratory reagents for outbreaks to support global partners to
prevent, detect, and respond to respiratory disease threats.
Additionally, in alignment with the Global Health Security Agenda
(GHSA) 2024 vision, CDC will enhance ongoing efforts to strengthen
global health security, with a focus on strengthening the core public
health capacities that countries need to prevent, detect, and respond
to infectious disease threats within their border. Building upon CDC
country platforms, CDC intends to expand global health security in-
country staffing in 19 intensive support countries to strengthen direct
collaboration with ministry of health counterparts and provide more
hands-on technical assistance and oversight of CDC-supported global
health security programs to accelerate progress.
violence intervention programs
Question. Gun shot injuries cost the health-care system between $1
billion to $2.8 billion a year. That is without taking into account
other costs surrounding these injuries, such as expenses related to
police, jails, lost wages to both victims and perpetrators, and more.
Under President Biden's leadership, we have taken significant steps
to reduce violent crime from the American Rescue Plan Act to the
Bipartisan Safer Communities Act.
In June 2021, the administration announced the White House
Community Violence Collaborative of cities using American Rescue Plan
Act (ARPA) funding to strengthen community violence intervention (CVI)
programs. Baltimore City took part in this, and thanks to funding from
ARPA, the city is investing over $50 million in the coming years on a
comprehensive violence prevention strategy. This includes CVI programs,
victim support services, case management, emergency housing, and
reentry services.
Additionally, the administration has placed a focus on hospital-
based violence prevention programs and called on States to expand
Medicaid to cover these services. I am proud that Maryland General
Assembly passed legislation last year to do so.
I was pleased to see the President's continued call for strong
investments in community violence intervention programs in the
President's budget.
Can you comment on the importance of also having a public health
approach to combat violent crime and the administration's commitment to
this work?
Answer. Violence is a widespread public health problem that impacts
all of us and has a profound impact on lifelong health and well-being.
The causes of violence are complex and require a comprehensive public
health approach complementary to a public safety and criminal justice
approach. CDC's public health approach focuses on early intervention:
engaging people in prevention strategies before they intersect with the
justice system, with the goal that they never become a perpetrator or
victim of violence.
Like disease, violence is preventable. A public health approach
uses the same scientific methods to prevent violence that have been
used to prevent disease: collecting data to understand trends and
differences across groups, supporting research to develop prevention
strategies and to understand what works, and taking steps to ensure
that proven strategies are implemented in communities nationwide.
Public health draws on a science base that is multi-disciplinary.
It relies on knowledge from a broad range of disciplines including
medicine, epidemiology, sociology, psychology, criminology, education,
and economics. The public health approach also emphasizes input from
diverse sectors including health, education, social services, justice,
and the private sector. Collective action on the part of these key
collaborators is important for addressing problems like violence.
CDC's National Violent Death Reporting System pools information
from multiple data sources into a usable, anonymous database describing
the circumstances of homicides and suicides in all 50 States,
Washington, DC, and Puerto Rico. CDC also currently funds 9 Injury
Control Research Centers studying how to prevent injuries and violence
and working with community partners to put those findings into action.
Additionally, CDC funds 5 Youth Violence Prevention Centers to target
youths in communities with high rates of violence. CDC has developed
technical packages specifically for preventing adverse childhood
experiences, child abuse and neglect, intimate partner violence, sexual
violence, youth violence, and suicide for use as tools for communities,
States, territories, and partner groups to plan and implement violence
prevention efforts.
CDC has a long history of working with multiple sectors at the
community level to improve health and well-being. Public health leads
violence prevention efforts in the context of underlying contributors
that are beyond the reach of the justice sector, such as substance use,
community design, and concentrated poverty. As a result, CDC is well
positioned to partner with health-care workers, as well as health
organizations such as hospitals, mental and behavioral health systems,
insurance providers, schools, and others to prevent violence and
mitigate its consequences.
hepatitis c
Question. As you know, hepatitis C is a liver infection caused by a
blood-borne virus that can lead to acute or chronic infection and cause
liver disease and cancer. The number of Americans impacted by hepatitis
C has more than doubled since 2013, with more than 2.5 million people
nationwide infected. This includes over 100,000 Marylanders. However,
over 40 percent of people infected are unaware because they are
asymptomatic.
Acute and chronic hepatitis C disproportionately affect American
Indian and Alaska Natives, Black Americans, people aged 20 to 39 and 55
to 70, those without insurance, and those with substance use disorders.
The President's budget proposes bold action to eliminate hepatitis
C through a new 5-year initiative, the National Hepatitis Elimination
Program, which would enhance screening, testing, treatment, and
prevention efforts with a focus on the
highest-risk populations.
Can you discuss the importance of eliminating hepatitis C and why
it is within our reach if we choose to invest in it?
Importance of Eliminating Hepatitis C
Answer. Recent published data indicates that the rates of acute
hepatitis C quadruped from 2010 to 2020 among adults aged 20-39 years,
mirroring increasing rates of overdose deaths fueled by the Nation's
opioid and methamphetamine crises. Untreated hepatitis C can lead to
cirrhosis, liver failure, liver cancer, and a wide range of extra-
hepatic disease processes, such as cryoglobulinemia, depression, and
non-Hodgkin lymphoma which often occur in the absence of clinical liver
disease and have extensive direct and indirect costs of their own.
One study estimated that a 2-year delay in access to the direct-
acting antivirals (DAAs) can lead to increased hepatitis virus-related
morbidity and mortality by 15 percent \52\ If these patients are left
untreated, up to 30 percent will develop liver cirrhosis after 20 years
\53\ and of these, about 4 percent of patients a year will develop
liver cancer (hepatocellular carcinoma). The cost of treating liver
complications such as liver failure and transplantation once the
disease has advanced far exceeds the costs related to the treatment of
HCV before any of these complications occur.
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\52\ Starkel P, Vandijck D, Laleman W, Van Damme P, Moreno C, Blach
S, Razavi H, Van Vlierberghe H. Acta Gastroenterol. The Disease Burden
of Hepatitis C in Belgium: An update of a realistic disease control
strategy. Belg. June 2015 78(2):228-32. Accessed on April 26, 2023.
\53\ Chopra S. Clinical manifestations and natural history of
chronic hepatitis C virus infection. Waltham, MA: UpToDate; 2014.
Accessed on April 26, 2023.
To put it in context using a 2014 data,\54\ the proportion of in-
hospital stay involving HCV on average were higher in cost ($13,300
versus $11,600); longer (5.8 versus 4.7 days) and more likely to result
in death in the hospital (2.9 versus 2.2 percent of stays) compared to
the in-hospital stays that did not involve HCV.
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\54\ Ngo-Metzger Q (AHRQ), Mabry-Hernandez I (AHRQ), Heslin KC
(AHRQ), Weiss AJ (IBM Watson Health), Mummert A (IBM Watson Health),
Bierman AS (AHRQ). Characteristics of Inpatient Stays Involving
Hepatitis C, 2005-2014. HCUP Statistical Brief #232. November 2017.
Agency for Healthcare Research and Quality, Rockville, MD, https://
hcup-us.ahrq.gov/reports/statbriefs/sb232-Hepatitis-C-Hospital-Stays-
Trends.pdf. Accessed on 04/26/23.
Yet, we have safe and effective oral treatment--DAAs that can cure
greater than 95 percent of infected people in 8 to 12 weeks. This cure
is one of the most dramatic scientific achievements of the last few
decades; however, it is not reaching the population who needs it most.
Among those diagnosed, only one-third with private insurance and one-
quarter with Medicaid and Medicare received timely treatment (within
360 days of diagnosis).\55\
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\55\ https://www.cdc.gov/mmwr/volumes/71/wr/pdfs/mm7132e1-H.pdf.
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Why it Is Within Our Reach if We Choose To Invest in it
The United States is currently not on track to reach elimination
goals outlined in the Viral Hepatitis National Strategic Plan 2021-2025
due to limited investment in hepatitis C. Reasons for the slow progress
include low screening and diagnosis of hepatitis C, the
disproportionate impact of hepatitis C on marginalized populations,
increasing rates of hepatitis C in young adults due to the opioid
epidemic, gaps in linking patients to care, and insurance restrictions
to treatment.
Broad access to curative hepatitis C medications: Early treatment
with the new DAAs offers savings in medical costs, by offsetting part
of the initial expense, and improving health status. In a model
analysis published in a study, it estimated that waiting to initiate
treatment in advanced stages of HCV will cost billions of dollars in
medical and treatment expenditure over decades with little reduction in
prevalence.\56\ The same study also estimated that by front loading
expenditures, to treat all HCV diagnosis regardless of the extent of
liver damage will substantially lower prevalence within 10 years. In
their estimation, over time, cumulative expenditure declines as
transmission, prevalence, and incidence of disease decreases.
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\56\ Van Nuys K, Brookmeyer R, Chou J et al. Broad Hepatitis C
Treatment Scenarios Return Substantial Health Gains, But Capacity Is a
Concern. Health Affairs 34, no.10 (2015):1666-1674 doi: 10.1377/
hlthaff.2014.1193. Accessed on April 26, 2023.
Innovative testing development: Using the lessons learned from
COVID-19, this initiative would accelerate approval of point-of-care
RNA tests that are available outside of the U.S. but not in the U.S.,
by enlisting the Independent Test Assessment Program, an NIH-Food and
Drug Administration partnership. Currently, in the U.S., the tests must
be processed at off-site labs, forcing patients to return to obtain the
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results and further delaying their treatment and care.
Population health and health equity: Investment in hepatitis C
elimination is also an investment in addressing equity. Hepatitis C
disproportionately affects populations experiencing other health and
social inequities, including American Indian and Alaska Native persons,
non-Hispanic Black persons, individuals without health insurance,
justice-involved populations, and people who inject(ed) drugs.
Hepatitis C also disproportionately affects baby boomers many of whom
are eligible for Medicare. The prevalence of hepatitis C is at least
five times higher among baby boomers than in any other group of adults,
and baby boomers account for about 75 percent of hepatitis C cases
(https://www.health.harvard.edu/blog/baby-boomers-and-hepatitis-c-
whats-the-connection-2019050116532). Moreover, the diagnosis and
treatment of hepatitis C in this group would result in significant
savings for Medicare as it would identify those with long-duration
chronic disease, who are at highest risk for the most advanced forms of
liver disease.
Lessons learned from tested models: The National Hepatitis C
Elimination Program was developed by taking lessons learned from
innovative programs from across the U.S., including from the States of
Louisiana and Washington, the Cherokee Nation, the Veterans' Health
Administration (VHA), and the Federal Bureau of Prisons. For example,
from 2013 to March 2021, the VHA screened >85 percent of its population
for hepatitis C. Of the 168,000 VHA patients diagnosed with hepatitis
C, 90 percent have been treated, with a 90 percent cure rate. Model
pilot programs across the country have provided the evidence base for
nationwide scale-up of successful strategies. Investment in these
strategies will prevent needless suffering for patients and their loved
ones.
It is estimated that the National Hepatitis C Elimination Program
will diagnose 92.5 percent and cure 89.6 percent of all people living
with hepatitis C within 5 years if we act now.
______
Questions Submitted by Hon. Sherrod Brown
funding for children's hospitals graduate medical education
Question. The Children's Hospitals Graduate Medical Education
(CHGME) program is vital for training the next generation of
pediatricians. The children's hospitals that receive this funding train
about half of all our Nation's pediatricians and a majority of
pediatric specialists. Despite the program's success, CHGME has
consistently received far less Federal funding than provided to
graduate medical education for adult providers. The President's budget
for FY 2024 proposes $385 million for CHGME--the same Congress
appropriated for FY 2023. Our Nation is facing a health-care workforce
crisis, and we lack the pediatric specialty providers necessary to care
for our children. I am concerned that the lack of increase in funding
further jeopardizes the ability for our country to maintain a robust
pediatric workforce.
Will you work with me to ensure that we prioritize CHGME moving
forward to protect children's access to care?
Answer. Thank you for your support of the Children's Hospitals
Graduate Medical Education (CHGME) program. We recognize the importance
of having an adequate number of pediatric providers and ensuring
children have ongoing access to the specialized care they need across
provider settings. This important program supports pediatric providers
and promote access to health care.
The FY 2024 President's budget proposal for the CHGME program would
enable HRSA to continue to support resident physician full-time
equivalent placements training in free-standing children's hospitals.
We look forward to working with Congress to provide sufficient funding
to strengthen the pediatric workforce and expand access to care for
children through the CHGME program.
access to vaccines for adult medicaid beneficiaries
Question. When Congress passed the Inflation Reduction Act, it
included legislation I sponsored requiring access to all recommended
vaccines at no cost for low-income adults who are Medicaid
beneficiaries, regardless of what State they live in. The President's
FY 2024 budget supports CMS activities to implement this benefit.
Could you share an update on CMS's implementation of section 11405?
How is CMS assisting States in getting ready for the October 1,
2023, effective date for these changes to adult immunization coverage
in their Medicaid programs?
Answer. The Inflation Reduction Act addresses longstanding gaps by
requiring coverage of vaccinations for adults under Medicaid and CHIP.
Starting October 1, 2023, most adults enrolled in Medicaid or CHIP will
have coverage of approved adult vaccines recommended by the Advisory
Committee on Immunization Practices, and the administration of those
vaccines without cost sharing. Increasing access to recommended
vaccines is an effective strategy to improve the health of Medicaid
adults and, more broadly, the health of communities. CMS is committed
to working closely with States to ensure they have the tools and
resources they need to ensure they are able to meet these new
requirements.
implementation of the technical reset to advance the instruction of
nurses (train) act (section 4143 of the consolidated appropriations act
for fiscal year 2023)
Question. Congress included bipartisan legislation I introduced
with Senator Capito, the TRAIN Act, as section 4143 of the Consolidated
Appropriations Act (CAA) for FY 2023, which was signed into law in
December. This provision ensures eligible hospital-based nursing
schools and allied health training programs be held harmless for excess
funds inadvertently disbursed by the Centers for Medicare and Medicaid
Services (CMS) as part of Medicare Advantage Nursing and Allied Health
Professional Education Payments in past years. Because this legislation
was not enacted until after most of these overpayments had been clawed
back, the Centers for Medicare and Medicaid Services (CMS) must now
repay these funds to the affected schools.
A March 16, 2023, CMS Transmittal Notice (Transmittal 11904, Change
Request 13122), set forth instructions to implement this section,
including a complicated formula to calculate the payments owed to
schools. However, it is my understanding that a number of schools that
have used these instructions to determine what they will get repaid
have found that they will only be reimbursed between 29 percent and 37
percent of what was clawed back by CMS. That is not what was intended.
My office and Senator Capito's office worked closely with CMS on this
provision. Our intention was to ensure that all schools be held
harmless--that they have all of the clawed-back funds returned to them.
How did CMS determine the formula for the repayments required under
section 4143 of the CAA?
How does CMS intend to ensure these schools are held harmless for
the overpayments, as per congressional intent?
Answer. CMS has recently been made aware of this issue, and I know
that folks are working to clarify any confusion. CMS is committed to
implementing this provision of the CAA correctly.
access to childhood vaccines at pharmacies
through the end of fiscal year 2024
Question. Every year, thousands of Ohioans turn to trusted
pharmacists in their communities to receive vaccinations. Vaccines are
essential in protecting and preserving the health of communities, and
health equity depends on vaccine access. Ohioans now expect that they
can access vaccines at their local pharmacies, particularly in minority
and underserved communities, where the pharmacy may be the easiest,
most convenient place to receive vaccinations. The Federal PREP Act
included the authority for pharmacists and pharmacy technicians to
perform all vaccines recommended by the Centers for Disease Control and
Prevention's Advisory Committee on Immunization Practices for children
ages 3-18 until October 1, 2024.
Could you confirm that HHS intends to maintain these authorizations
until October 1, 2024?
Answer. If a need is determined, the Secretary is able to amend
coverage post the duration of a declared Public Health Emergency for
PREP Act coverage for select groups of providers. At the time of the
hearing, there are conversations around extending coverage.
home respiratory therapy medicare coverage after
the public health emergency
Question. I understand that CMS plans to continue Medicare coverage
without additional documentation for patients who began home
respiratory therapy during the COVID-19 pandemic once the public health
emergency is ended. Will CMS provide guidance to ensure that these
patients continue to receive these services without interruption?
My understanding is that CMS contractors rely on physician notes in
the medical record as the only source for determining medical necessity
for home respiratory therapy. CMS's data indicates that contractors
deny the majority of these claims even when the patient qualifies for
services. Though CMS has developed a standardized template form that
physicians could use to ensure they are providing the information the
contractors need to review claims, CMS does not require its contractors
to adopt this approach. This puts patient access to home respiratory
therapy at risk. Could you explain why CMS has not implemented a
requirement to use this standardized template and whether the
contractors will be required to use this type of documentation when the
public health emergency ends?
Answer. CMS recognizes that it is important for stakeholders to
understand how CMS anticipates performing medical review after the
Public Health Emergency (PHE) has ended. During the PHE, flexibilities
were applied to medical reviews across claim types. For certain DME
items, this included the non-enforcement of clinical indications for
coverage. Since clinical indications for coverage were not enforced for
certain DME items provided during the PHE, once the PHE ends CMS plans
to primarily focus reviews on claims with dates of service outside of
the PHE, for which clinical indications of coverage are applicable. CMS
may still review these DME items, as well as other items or services
rendered during the PHE, if needed to address aberrant billing
behaviors or potential fraud. The HHS-Office of the Inspector General
may perform reviews as well. All claims will be reviewed using the
applicable rules in place at the time for the claim dates of service.
As the PHE comes to an end, CMS will continue to work with stakeholders
to ensure beneficiary access.
CMS has designed printable clinical templates and suggested
clinical data elements (CDEs) to assist providers and IT professionals
with data collection and medical record documentation to support
coverage of selected items and services. These templates and suggested
CDEs are intended to help reduce the risk of claim denials and ensure
that medical record documentation is more complete. Specifically, CMS
released a clinical template and suggested CDEs for ordering home
oxygen therapy. The template is designed to assist a clinician when
completing an order for home oxygen therapy to meet requirements for
Medicare eligibility and coverage. The template meets the requirements
for both the Detailed Written Order and Written Order Prior to
Delivery, and is available to the clinician and can be kept on file
with the patient's medical record or can be used to develop an order
template for use with the system containing the patient's electronic
medical record. While completing the Home Oxygen Therapy Order Template
does not guarantee eligibility and coverage, it does provide guidance
in support of home oxygen therapy equipment and services ordered and
billed to Medicare. CMS has also released clinical templates and
suggested CDEs for documenting the face-to-face encounter for Medicare
home oxygen therapy eligibility and coverage and for documenting
information regarding home oxygen therapy laboratory test results to
meet requirements for Medicare coverage for home oxygen therapy. The
home oxygen therapy templates and suggested CDEs are available at:
https://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-
and-Systems/Electronic-Clinical-Templates/template-and-CDE-downloads.
At this time, use of these templates and suggested CDEs is
voluntary; however, we welcome provider and stakeholder feedback and
suggestions on how to improve all our templates and CDEs.
______
Questions Submitted by Hon. Michael F. Bennet
antimicrobial resistance
Question. According to the Centers for Disease Control and
Prevention (CDC), in just the first year of the COVID-19 pandemic, U.S.
hospitals experienced a 15-
percent increase in both infections and deaths from drug-resistant
bacteria. To prepare for the next pandemic or superbug, we need to
address the broken drug pipeline. My legislation with Senator Young,
the PASTEUR Act, which we've talked about, would incentivize new
antimicrobial drug development at a small fraction of the cost that
antibiotic resistance imposes on American patients and consumers and
will jumpstart the next generation of drugs that will make that
possible. I appreciate that HHS includes a $9 billion proposal in
mandatory funding for a subscription model to incentivize the
development of novel antibiotics.
Can you tell me more about the administration's proposal for
antimicrobial pull incentives included in your budget to tackle this
problem?
Can we work together to get it passed this year as part of the
Pandemic and All Hazards Preparedness Act (PAHPA) reauthorization?
Answer. To mitigate the threat of antimicrobial resistance, the
U.S. Government is taking a multipronged approach that includes
surveillance, prevention, stewardship and innovation of new products to
treat and prevent infections. However, the value of reduced morbidity,
mortality, and disease duration is not currently captured by many
antimicrobial products' current market value, and many large
pharmaceutical companies have stopped investing in new antimicrobial
products. The majority of products currently in clinical trials are
being developed by small companies without the infrastructure and
economies of larger firms--these small companies face difficulty self-
funding commercialization and Phase 4 studies and the development
pipeline is at significant risk of falling short of current and future
needs.
The FY 2024 President's budget mandatory proposal is intended to
create an incentive for a more robust pipeline of novel antimicrobial
products while enhancing stewardship. The proposal would allow for
contracts to be established between sponsors of selected products and
HHS, valued at between $750 million and $3 billion, paid in annual
increments for up to 10 years or through the length of protection or
exclusivity. The proposal would establish an interagency committee to
identify infections for which new antimicrobial drugs are needed and to
develop regulations outlining favored characteristics and assigned
monetary values, an application process for product sponsors, how
contracts would be established, and how characteristics would be
weighed. The proposal addresses patient access to these products by
requiring assurances from sponsors regarding supply chain and supply
adequacy. Building on the strength ongoing programs like CARB-X, this
proposal would allow the HHS Secretary to work with private payors and
global partners to participate in a similar mechanism.
We have appreciated the opportunities to provide technical
assistance on previous versions of the PASTEUR Act and would be happy
to do so in the future. Similarly, we look forward to engaging with you
on reauthorization of PAHPA.
Question. The COVID-19 pandemic has intensified the misuse and
overprescribing of antibiotics which has increased the spread of
antimicrobial resistance in the United States and around the world.
Recent examples of resistance include the eye drop recall and the
alarming spread of Candida auris--a deadly fungal infection--in
hospitals. Diagnostic tests are not adequately being utilized prior to
the prescription of an antibiotic.
How will HHS help support efforts to decrease empiric antimicrobial
therapy?
What kinds of policies might you propose to help address
stewardship and improve the use of diagnostic tests?
Answer. Through the 2020-2025 National Action Plan for Combating
Antibiotic-Resistant Bacteria (CARB), HHS is working with Federal,
State, and local partners to implement a suite of complementary actions
to combat antibiotic resistance. The National Action Plan for CARB
includes two goals particularly relevant to appropriate antibiotic use.
Goal 2 supports antibiotic stewardship, which guides appropriate
antibiotic use and thereby reduces the opportunities for resistance to
develop. Goal 3 supports the development and appropriate use of
diagnostic tests to provide the right antibiotic at the right time in
the right dose.
CDC, AHRQ, and CMS support the development, evaluation, and
implementation of high-quality antibiotic stewardship programs across a
variety of health-care settings. CDC's Core Elements of Antibiotic
Stewardship offer providers and facilities a set of key principles to
guide efforts to improve antibiotic use and, therefore, advance patient
safety and improve outcomes; this guidance has been tailored for
hospitals, outpatient settings, nursing homes, and resource-limited
settings. The AHRQ Safety Program for Improving Antibiotic Use was
developed to help clinicians in hospitals, doctors offices, and long-
term care apply the Four Moments of Antibiotic Decision Making and
concepts derived from the Comprehensive Unit-based Safety Program
(CUSP) to improve antibiotic stewardship by selecting the optimal
antibiotic regimens, routes of administration, and durations. AHRQ and
partners assessed the Safety Program's impact on patient safety culture
and antibiotic prescribing practices across a total of 1,304
participating sites throughout the United States, including 476 units
from 402 acute care hospitals, 439 long-term care facilities, and 389
ambulatory care centers. Results indicate that the Safety Program aided
participating sites to develop and enhance their Antibiotic Stewardship
activities and to reduce antibiotic prescribing. At the end of each
intervention, a toolkit was developed that contained materials
developed for each cohort as well as additional information to allow
sites that did not participate to recreate the Safety Program at their
own facilities. CMS works closely with CDC in the development of its
antibiotic stewardship program requirements as well as the interpretive
guidelines that support these regulations. Through its published rules
and guidance, CMS has strongly encouraged health-care facilities to use
CDC's Core Elements of Antibiotic Stewardship as a basis for
establishing antibiotic stewardship programs in Medicare-participating
facilities. In 2022, CMS published updates to interpretive guidance for
hospital requirements under the Medicare and Medicaid Programs;
Regulatory Provisions to Promote Program Efficiency, Transparency, and
Burden Reduction Final Rule, which revised the regulatory requirements
for hospitals related to infection prevention and control and
antibiotic stewardship programs.
CDC, AHRQ, NIH, and FDA are working under the National Action Plan
for CARB to fund research to better understand the appropriate use of
diagnostic testing to address bacterial or fungal infections, and to
use that evidence to promote the appropriate use of new and existing
diagnostics that determine the presence, severity, or antimicrobial
susceptibility or resistance of bacterial or fungal infections in human
clinical care. For example, CDC used data from their Gonococcal Isolate
Surveillance Project to guide updates to the 2020 gonorrhea treatment
recommendations published in the Morbidity and Mortality Weekly Report.
These data were used in determining recommended treatment regimens and
for test-of-cure testing recommendations.
HHS agencies continue to monitor the implementation of these
activities to understand their impact and develop additional proposals
to support appropriate antibiotic use, including through improved
diagnostic testing. For example, the FY 2024 President's budget
includes a proposal for CDC to advance laboratory science through
shortening the time to develop diagnostic tests, evaluating and
implementing new detection technologies, increasing the number of tests
results available per day, ensuring the quality of test results,
improving laboratory safety and efficiency, and developing uniform
quality practice standards for CDC and other public health labs. The FY
2024 President's budget request for AHRQ includes an investment in
research grants and contracts to explore how to address different
diagnostic safety challenges and create the infrastructure for
continued research to prevent errors and delays in diagnosis.
diagnostic testing
Question. Due to the Protecting Access to Medicare Act of 2014
(PAMA), laboratory diagnostics and point-of-care testing reimbursement
has experienced continued downward reimbursement, reducing common
diagnostic testing reimbursement by up to 10 percent year over year.
Without congressional intervention, reimbursement reductions are
scheduled to continue under PAMA.
Considering the critical role diagnostic testing has in our health-
care industry and in combating the COVID-19 pandemic, how do you plan
to address reimbursement rates to maintain long-term access to testing?
Answer. The Department shares your desire to protect Medicare
beneficiaries' access to laboratory testing services and provide
stakeholders with transparency and predictability around reimbursement
for laboratory tests. Congress enacted PAMA with a phase-in for
reductions such that for CY 2017 through CY 2019, the reduction cannot
be more than 10 percent per year, and for CY 2020 through CY 2022, the
reduction cannot be more than 15 percent per year. Congress
subsequently modified PAMA in legislation four different times to
maintain the payment amount for a clinical diagnostic laboratory test
for CY 2021 through CY 2023 at the payment amount for CY 2020 and to
limit reductions to 15 percent per year for CY 2024 through CY 2026. If
Congress wants to make further modifications to the phase-in of
reductions under PAMA, we would be happy to provide technical
assistance on legislation you draft.
Question. When the Public Health Emergency ends on May 11th, many
private payers have indicated they will no longer cover and reimburse
COVID-19 tests done at point of care--meaning in pharmacies, urgent
care centers and physician office labs.
What is your plan to work with private payers to ensure all
Americans have access to point of care COVID-19 testing?
Answer. The requirement for group health plans and health insurance
issuers offering group or individual health insurance coverage to cover
COVID-19 tests without cost sharing, both for over-the-counter and
laboratory tests, will end at the end of the Public Health Emergency
(PHE). However, plans and issuers are encouraged to continue to provide
this coverage, without imposing cost sharing or medical management
requirements, after the PHE ends.
Question. Currently, the Food and Drug Administration (FDA) does
not have regulatory oversight of laboratory diagnostic tests, leaving
patients at risk of faulty high-risk tests and increasing the potential
of inaccurate diagnosis and treatment. I've collaborated for many years
with the FDA and stakeholders on the Verifying Accurate, Leading-edge
IVCT Development (VALID) Act, which would create a risk-based
regulatory framework at the FDA to oversee these tests. I'm glad that
the FDA plans to move forward in their current authority to draft
regulations, but I'm also surprised that the FY 2024 HHS Budget did not
include the VALID Act as a policy priority.
Under which authorities do you believe that FDA can promulgate
regulations on diagnostic test oversight?
Answer. In vitro diagnostic products (IVDs) are devices under the
Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA has authority
to promulgate regulations for IVDs under the agency's general
rulemaking authorities and statutory authorities relating to devices
under the FD&C Act.
Question. Can you provide a timeline of when the public should
expect proposed regulations or sub-regulatory guidance?
Answer. At this time, we cannot provide a timeline.
Question. Do you and the FDA support the VALID Act and can you
explain why it wasn't included in the budget?
Answer. Yes. FDA supports legislation to establish a modern
regulatory framework for diagnostic tests under the Federal Food, Drug
and Cosmetic Act, such as the VALID Act. The legislative proposals in
the budget FY 2024 summary are legislative proposals originating from
FDA, whereas VALID is a legislative proposal originating from Congress.
Diagnostic test reform remains one of FDA's top legislative priorities
for reauthorization of the Pandemic and All-Hazards Preparedness Act. A
modern oversight framework that is specifically tailored to in vitro
diagnostics will help us position ourselves for the future--whether it
is preparing for the next pandemic or realizing the full potential of
diagnostic innovation. The past few years have highlighted the critical
need for a modern regulatory framework that strikes the appropriate
balance to promote innovation while also ensuring patients have access
to accurate and reliable diagnostics. FDA stands ready to continue
working with Congress on diagnostic testing reform.
unaccompanied children
Question. For nearly 10 years, Democratic and Republican
administrations have failed to care for unaccompanied children who come
to the United States. I've continued to raise concerns, when they have
been wrongfully detained under Flores or held in closed cells intended
for medical isolation. As of this week, nearly 8,000 children are under
HHS care, but there are likely tens of thousands more who are out of
HHS custody in the United States and face high risk of trauma and
health conditions. In the past three budgets, HHS has requested the
same amount, $5.5 billion, but, as far as I can tell, we haven't seen
improved outcomes and care for these children. In fact, we're now
hearing reports that employers are exploiting them to work in meat
packing facilities and other factories, which is shameful.
What is HHS meaningfully doing to strengthen care for kids in their
custody?
Answer. HHS's Administration of Children and Families' (ACF) Office
of Refugee Resettlement (ORR) is dedicated to ensuring the safety and
well-being of children in our care from the time they enter our custody
following a referral from the Department of Homeland Security (DHS) or
other Federal entity until they are safely placed with a vetted
sponsor.
ORR has made and continues to make significant investments in
acquiring additional bed capacity to provide a safe environment and
place children in the least restrictive setting appropriate for their
needs. Since 2021, ORR has nearly doubled its standard network bed
capacity, and has achieved this by safely bringing back online beds
that were previously impacted by COVID-19 restrictions, partnering with
current providers to provide additional bed capacity through recipient-
initiated supplements, engaging non-governmental organizations and
governmental jurisdictions to identify ways to expand bed capacity, and
publishing notices of funding opportunities (NOFOs) for licensed or
soon-to-be-licensed programs.
While ORR's custodial responsibilities end when a child is released
from ORR care, ORR provides post-release services (PRS) for children
and sponsors who would benefit from ongoing connections to community
services. ORR also conducts follow-up by phone with both the sponsor
and child after the child is released from ORR care to help continue
and facilitate a child's successful transition into their community and
encourage permanency.
ORR is also expanding PRS tailored to the unique needs of each
child. In FY 2022, ORR more than doubled the rate of children provided
with PRS, serving more than 40 percent of children compared to just
over 20 percent in FY 2021. ORR has been developing and progressing
with the implementation of expanded PRS, including a pilot project in
September 2022. This full rollout is anticipated to start January 1,
2024, and expanded PRS will consist of three levels of services, which
may be elevated at any time, ranging from Level 1 (consisting of three
check-ins) to Level 3 (involving intensive, in-person case management).
Safety and Well-Being Calls will be categorized under ``Level 1
Services,'' where three in-person or virtual comprehensive check-ins
are conducted with the unaccompanied child and sponsor at 7 days, 14
days, and 30 days following release from ORR care.
ORR continues to expand access to legal representation to children,
consistent with the requirements of law. In FY 2021, 13,579 children
received direct representation in their immigration proceedings through
ORR's contractor, and in FY 2022, this number increased to 16,299
children. Over the coming year, ORR plans to reach a historic expansion
in direct representation by funding an additional 15,000 direct
representation cases. ORR will achieve this by bringing on new legal
service providers in high release counties, where there has not
historically been immigration legal representation. This includes
intensive training and language support for these new providers, which
will help build long-term capacity in the field. Simultaneously, ORR is
working to increase funding and capacity for direct legal
representation for unaccompanied children, with the goal of ensuring
that all children in ORR care and discharged children can access legal
representation by the end of calendar year 2027.
In addition to expanding legal representation through the current
and new contracts, ORR developed a legal services recruitment pipeline
project in order to build capacity in the field and ensure that ORR can
continue to meet increased demand for legal services year after year.
ORR estimates that this project will lead the recruitment of over 4,000
new attorneys entering the immigration field over the next 5 years,
with more than 100,000 unaccompanied children matched with
representation under this program.
Question. How does HHS plan to improve their follow-up procedures
for kids who are no longer in HHS custody to ensure they aren't being
exploited?
Answer. HHS recognizes that unaccompanied children face unique
challenges that require a whole-of-government response, which is why we
engage with different entities across the Federal Government and
nationally in support of efforts to ensure the safety and well-being of
unaccompanied children. Any child being in a dangerous or exploitative
situation is cause for concern, and HHS takes action to provide
services and referrals, including reports to law enforcement and child
welfare authorities, as appropriate, as well as to examine our
processes and policies to identify and address any gaps.
On February 28, 2023, ACF finalized a Memorandum of Agreement (MOA)
between ORR, the Office on Trafficking in Persons, and the National
Center for Missing and Exploited Children where all parties share
information on a weekly basis for the purpose of assisting one another
to locate and assess the safety and well-being of unaccompanied
children, former unaccompanied children, and foreign national minors
who are reported missing or who may be subject to trafficking or
exploitative activity. The MOA helps bridge data-sharing gaps and
allows ORR to receive information on potential trafficking trends or
concerns with potential sponsors and document this critical information
in ORR's official system of record, the Unaccompanied Children Portal,
to inform ORR's case management considerations. The MOA also advances
priority actions as outlined in the National Action Plan to Combat
Human Trafficking, recommendations articulated by the National Advisory
Committee on the Sex Trafficking of Children and Youth in the United
States, and recommendations articulated by members of the National
Human Trafficking Training and Technical Assistance Center's Human
Trafficking Leadership Academy.
ORR's interagency efforts to conduct due diligence to prevent and
respond to the child labor issue is ongoing. The recent MOA between the
Department of Labor's (DOL) Wage and Hour Division and ACF, formalized
on March 23, 2023, expands our collaborative work and will help to
identify communities and employers where children may be at risk of
child labor exploitation; aid investigations with information that
could help identify circumstances where children are unlawfully
employed; and further facilitate coordination to ensure that child
labor trafficking victims or potential victims have access to critical
services. HHS and DOL are also distributing new materials and trainings
to provide information to children and sponsors about child labor laws
in the United States so that children and sponsors understand the laws
on labor rights and restrictions.
In addition to increasing our efforts to better inform children,
sponsors, and providers about child labor exploitation, ORR continues
to improve how it prevents and responds to child labor issues,
including ensuring follow-up calls to children with reported safety
concerns to the ORR National Call Center (ORRNCC) and sharing
information with children about where and to whom their concern was
reported. ORRNCC is a valuable resource that is available 24 hours, 7
days a week, where children, sponsors, family members, legal service
providers, Child Advocates, and other members of the community can
request assistance, report concerns, and be referred to essential
community services to promote success and community permanence on the
child's behalf. ORRNCC is required to document and report any safety
concern, in accordance with mandatory reporting laws, State licensing
requirements, Federal laws and regulations, and ORR policies and
procedures to ORR, as well as to the appropriate local law enforcement
agency, State and local child protective services, or both.
Lastly, ORR has invested in proactive program quality and program
management capabilities with child safety and well-being at its core.
ORR created two new teams that aid its efforts to provide holistic
support to children while in care and post-release: the Child Services
Team and the Program Quality Team. The Child Services Team is
responsible for continuing existing work that ensures children receive
legal support; child advocacy, as needed; post-release services; and
language access. This team also leads efforts to build out ORR's
provision of appropriate education and vocational supports for all
children in care as well as to engage with internal and external
stakeholders to advance policies and procedures that prioritize child
protection and family preservation for unaccompanied children, their
caregivers, and broader communities. The Program Quality Team was
established as a means of working continuously and collaboratively to
use child welfare best practices to achieve and sustain improvement in
services and outcomes for the children, youth, and families we serve.
Under this team, ORR works on continuous quality improvement and
emergent issues, internal monitoring and oversight of the care provider
network, prevention of child abuse and neglect, and care provider
engagement and performance management. Expanding the breadth of
services post-release starts with internal accountability and
sustainable program models to ensure the Unaccompanied Children Program
continues to develop the tools it needs to serve the best interests of
children.
child welfare
Question. Just over 5 years ago, in February 2018, Chair Wyden and
I successfully led the effort to pass the Family First Prevention
Services Act (FFPSA). This legislation provided families with greater
access to mental health services, substance use treatment, and/or
parenting skills courses so that children, who might normally be placed
in out-of-home care, could remain with their families at home. Since
then, many States have taken up the option to shift their child welfare
systems to better support prevention and reduce the number of kids
removed form their home. Currently, there are 39 approved State,
jurisdiction, and Tribal title IV-E prevention program plans to date
have identified 13 well-supported, 5 supported, and 5 promising
evidence-based programs (EBPs) and services for reimbursement in the
delivery of prevention services.
Can you provide an update on State implementation of the FFSPA and
highlight the resources available for States that want to amend their
State child welfare programs?
Answer. States and Tribes are in various stages of development and
implementation of title IV-E prevention plans. Currently, 42
jurisdictions have approved title IV-E prevention program plans. The
U.S. Department of Health and Human Services (HHS) has made various
technical assistance (TA) documents and toolkits available that can
support jurisdictions' prevention planning and implementation. For
example, the HHS Office of the Assistant Secretary for Planning and
Evaluation has developed a toolkit about title IV-E prevention.
Similarly, Children's Bureau's Center for States provides TA support.
We understand that developing a comprehensive prevention plan takes
time. Additionally, we know that many agencies continue to manage
unprecedented workforce and leadership challenges and changes. Since
the passage of FFPSA, the Center for States has provided customized
support to State and territorial child welfare agencies developing and
implementing prevention plans. To support these efforts, the Center for
States provides a continuum of TA to jurisdictions, including the
following:
Providing tailored, expert coaching and consultation through
direct TA around prevention program plan development and
implementation and related efforts;
Supporting peer groups that allow child welfare
professionals to virtually connect with colleagues working in
similar practice areas or on common initiatives;
Developing and disseminating resources, including
publications and tools on prevention-focused systems and FFPSA;
Conducting needs assessments related to prevention service
array (identifying candidates, needs, and analyzing service
array gaps), including providing support to States in selecting
appropriate prevention interventions;
Refining internal processes related to in-home services and
provider relationships, such as effective in-home case planning
and service identification in partnership with families,
ongoing safety and risk monitoring, collaboration and coalition
building among partners, workforce support, training, and
coaching;
Conducting strategic planning related to prevention program
plan development (including enhancing key partnerships related
to prevention) as well as efforts to come into alignment with
the National Model Foster Family Home Licensing Standards; and
Ensuring children and youth are placed in settings that
align with their needs, reducing the use of congregate care,
and helping States conduct root cause analyses and strategic
planning related to changing the culture and climate of their
agencies, including shifts toward a more prevention-based
model.
Question. Are there increased resources that the Administration for
Children and Families needs to improve or encourage implementation of
the FFSPA?
Answer. Our FY 2024 budget proposes to build on the progress noted
above by including a suite of proposals to enhance the title IV-E
Prevention Services Program. Our proposals would increase Federal
reimbursement for the program and, as you note, beginning in FY 2024,
make permanent a temporary provision enacted through the Family First
Transition Act requiring States to spend at least 50 percent for
services that meet the supported and/or well-supported practice
criteria (rather than applying that spending requirement to programs
meeting the well-
supported practice criteria only). The proposal also would allow up to
15 percent of a State's funding to be spent on services that do not
currently meet the clearinghouse's evidence standards. As a condition
of this, States would be required to evaluate these services and would
need to either modify the service (and reevaluate the modified service)
or cease using title IV-E funding for it if the evaluation shows the
service to be ineffective. Combined, these proposals would further
incentivize States to invest and scale up their IV-E prevention
programs while giving States the flexibility to provide each child and
family with the most appropriate and tailored services for their needs.
The proposal also includes $10 million per year to enhance the
operation of the Clearinghouse and to support timely evaluations and
technical assistance on evaluations to develop additional evidence-
based programs. Finally, the proposal includes a change in the law to
allow Tribes participating in the program through a State-Tribe title
IV-E agreement to use interventions adapted to the culture and context
of Tribal communities, exempting them from the requirement to use only
programs rated as well supported, supported, or promising. (Currently,
this flexibility is available only to Tribes operating the title IV-E
Prevention Services program directly, rather than through a State-Tribe
agreement.) The proposal would also specifically allow States to use
cultural adaptations of interventions that have been rated by the
clearinghouse as promising, supported, or well-supported.
______
Questions Submitted by Hon. Robert P. Casey, Jr.
Question. The Health and Human Services FY 2024 Budget in Brief
includes a proposal to ``revise the special focus facility program'' in
the section on Survey and Certification. Can you detail how the special
focus facility program will be revised? Please include a breakdown of
how the Survey and Certification funding, including the proposed
increase, will address the special focus facility program.
Answer. The President's Fiscal Year 2024 budget requests $566
million for Survey and Certification, an increase of $159 million or 39
percent above FY 2023 enacted. Twenty million of this request supports
specific CMS actions outlined in the White House 2022 fact sheet aimed
at improving safety and quality of care in the Nation's nursing homes.
This includes addressing the backlog of complaints, revising the
special focus facility program, and expanding financial penalties for
poor-performing facilities.
CMS's Special Focus Facility (SFF) program identifies the poorest-
performing nursing homes in the country for increased scrutiny in an
effort to immediately improve the care they deliver. The SFF program
currently requires more frequent compliance surveys for program
participants, which must pass two consecutive inspections to
``graduate'' from the program. As noted in the White House Fact Sheet,
Protecting Seniors by Improving Safety and Quality of Care in the
Nation's Nursing Homes, the SFF program will be overhauled to more
quickly improve care for the affected residents, including changes that
will make its requirements tougher and more impactful. CMS will also
make changes that allow the program to scrutinize more facilities, by
moving facilities through the program more quickly. Facilities that
fail to improve will face increasingly larger enforcement actions,
including termination from participation in Medicare and Medicaid, when
appropriate. Additionally, on October 21, 2022, CMS released a SFF
Program policy memo revising the SFF program to protect and improve the
quality of care that residents living in these facilities receive.
These changes aim to address facilities remaining in the SFF program
for too long and facilities with ``yo-yo'' noncompliance after
graduating. Additionally, because of the importance of nursing home
staffing, CMS is informing State Survey Agencies to consider a
facility's staffing levels data when selecting SFFs from the SFF
candidate list.
Question. In February, the United Cerebral Palsy and the American
Network of Community Options and Resources (ANCOR) published a report
entitled ``The Case for Inclusion'' that contained a number of alarming
findings about the home-care workforce. The report documents families
and individuals in need of these services being turned away by
providers because they do not have sufficient staff. It also documents
providers closing complete programs because of lack of staff. What
efforts is HHS taking to both improve the recruitment and retention of
workers providing home and community-based services?
Answer. Within HHS, the Administration for Community Living (ACL)'s
budget request for FY 2024 seeks to strengthen both. With respect to
the paid direct-care workforce, HHS/ACL is currently funding the
development of a Direct Care Workforce Center (https://acl.gov/news-
and-events/announcements/acl-launches-national-center-strengthen-
direct-care-workforce) through which State, private, and Federal
entities involved in the recruitment, training and retention of direct-
care workers can access model policies, best practices, training
materials, technical assistance, and learning collaboratives. Funding
in FY 2024 will support continued operations of the Center and
establish demonstration grants to develop partnerships across State
aging, disability, Medicaid, and labor/workforce agencies and with
aging, disability, labor and provider stakeholders to implement
recruiting, retention, and training approaches to strengthen the
direct-care workforce at State and local levels. The Direct Care
Workforce Center is designed to catalyze change at a systems level that
will address the insufficient supply of trained direct care workers,
including Direct Support Professionals to assist individuals with
disabilities to become and stay employed and live in the community,
promote promising practices at all levels of the service system, and
improve data collection to enable a full understanding of the workforce
issue. The anticipated outcomes of this effort, include but are not
limited to:
Increasing the availability and visibility of tools and
resources to attract, train and retain the direct care
workforce in quality jobs where they earn livable wages and
have a voice in their working environment and have access to
benefits and opportunities for advancement; and
Increasing the number of States that develop and sustain
collaborations across State systems and workforce agencies to
implement strategies that will improve the recruitment,
retention, and advancement of high-quality direct-care
workforce jobs.
Question. Late last year, CMS proposed that Medicare cover seat
elevation systems for people with disabilities. The final approval of
this policy will mean better physical, emotional, and social
development for thousands of people who have serious physical
limitations. CMS has not, however started the process to cover standing
systems for people with disabilities. Please provide us with an update
on the process for considering and approving standing system coverage
by Medicare.
Answer. In February 2023 CMS published a proposed National Coverage
Determination (NCD) to expand Medicare coverage for power seat
elevation equipment for individuals with a Group 3 power wheelchair.
The public comment period closed on this NCD last month. CMS plans to
consider standing equipment in a separate future national coverage
analysis. I'm happy to stay in touch with you as CMS undertakes this
process.
Question. I appreciate President Biden's focus on lowering drug
costs for all Americans. As you know, Pennsylvania is home to a vital
life sciences industry. It is important that we ensure that research
and development remain strong, while reducing costs. How are you
working to maintain the development of new therapeutics?
Answer. The ecosystem in which FDA operates is rapidly evolving,
with unprecedented scale and investment in drug (including biologics)
development, increasing complexity in clinical trial designs, and
expanding availability of drug development tools. To adapt to these
rapid changes, the agency continues to modernize and enhance our core
review processes to assure the safety and effectiveness of treatments
are meeting the medical needs of the American public most effectively
and efficiently. FDA is engaging with industry and other regulatory
counterparts in meetings and workshops to share information about novel
manufacturing approaches.
FDA aims to grow the scientific expertise of agency staff and
foster drug development and approval, particularly in areas of unmet
medical need (e.g., disease areas that lack approved treatment
options). Through scientific leadership we hope to:
Develop strategic approaches to address substantive issues
in drug development, particularly in areas of unmet medical
need;
Deepen review staff's scientific expertise and support
staff's professional development to continually enhance
efficient and effective regulatory decisions, informed by the
most current science in drug development; and
Encourage the most efficient and effective drug development
approaches to support safe and effective therapeutic options
for patients, increase competition, and expand access.
Question. Section 508 of the Rehabilitation Act of 1973 requires
Federal departments and agencies to ensure that information and
communication technology is accessible for people with disabilities.
Over the last year, I have used my position as chairman of the Aging
Committee to examine compliance with this law, and assess the
accessibility of Federal technology, including Federal websites, for
people with disabilities, older adults, and veterans. In December 2022,
I released ``Unlocking the Virtual Front Door,'' an investigation that
found troubling examples of inaccessible technology across the Federal
Government, and which issued 12 recommendations to improve
accessibility. In February 2023, the Department of Justice (DOJ)
responded to my calls for greater transparency of section 508
compliance, releasing data that confirmed the findings of my report.
I am concerned that people with disabilities are being locked out
of government services and are not given a level playing field in
Federal workplaces due to inaccessible technology at the Department of
Health and Human Services (HHS). According to data HHS submitted to
DOJ, 90 percent of the 98,861 Internet webpages that were evaluated are
compliant with section 508 accessibility requirements, while 71 percent
of 1,430 intranet webpages that were evaluated are compliant. Moreover,
25 years after section 508 was signed into law, HHS reported that two
of its program areas--Compliance Process and Training--are not at the
General Service Administration's (GSA) highest program maturity level.
These data are consistent with the findings of my investigation, which
identified examples of inaccessible technology at HHS and its agencies.
Given these concerns, please answer the following question: how
does HHS plan to improve section 508 compliance for its external
websites, internal websites, and other electronic and information
technology?
Answer. HHS has undergone an extensive program maturity exercise
within the last 3 years. Efforts included piloting new tools,
processes, and accessibility services to improve acquisition, IT
development, and web content conformance. The outcomes of these pilot
projects have resulted in internal partnerships, and new services
contract vehicle that extend digital accessibility resources throughout
HHS. Operating Divisions and Staff Divisions can purchase services
offered throughout the agency include options for accessibility tools,
testing, remediation, web crawling and calibration, strategic planning,
governance activities, section 508 program analytics and process
improvements, virtual assistive technology lab, and assistive
technology guidance.
Question. Please explain the deficiencies in HHS's complaints
process and training that are identified in the DOJ report. How and
when does HHS plan to meet GSA's highest program maturity level for
these accessibility programs?
Answer. The HHS Digital Accessibility Program is in collaboration
with the Office for Civil Rights (OCR), which owns the complaint
process, to develop and publish guidance on submitting complaints and
helpful steps to ensure conformance of content to avoid future
complaints. The OCR process for filing a section 508 complaint is
provided in the HHS Policy for section 508 Compliance and Accessibility
of Information and Communication Technology (ICT) which is publicly
posted on our website.
Question. HHS reported evaluating 98,861 Internet webpages and
1,430 intranet webpages, respectively. What percentage of HHS's total
Internet and intranet webpages were evaluated?
Answer. HHS takes a proactive approach to website conformance that
validates webpages and content prior to posting online. Then utilizing
scanning tools, section 508 programs can audit the content and process.
The scans reported represent about 8 percent of the Internet webpages
and .3 percent intranet webpages. The HHS Digital Accessibility Program
is issuing a new services contract that increases the scanning and
calibration of Internet and intranet pages. Once the new contract is in
place, the program will begin routinely scanning and calibrating the
scan results for all Operating Division homepages. In addition, the HHS
Digital Accessibility Program will continue to provide an enterprise
solution for Operating Divisions to scan Internet and intranet
websites.
Question. Please describe the existing pathways for employees and
the public to file section 508 complaints with HHS at a departmental
level, as well as at the Centers for Disease Control and Prevention,
the Centers for Medicare and Medicaid Services, and the Food and Drug
Administration. Please provide the number of section 508 complaints HHS
as a whole, and CDC, CMS and FDA on an agency level, have received for
each of the last 5 fiscal years.
Answer. Formal complaints must either be routed to the Office for
Civil Rights (OCR) or the Equal Employment Opportunity (EEO) office. It
is up to the party filing the complaint to determine if an OpDiv-level
or agency-wide entity will receive the submission. Upon request of an
OCR or EEO entity, the respective section 508 program manager or
designee will assist in the complaint process. Each OpDiv section 508
program manager or designee is responsible for aiding in complaints
pertaining to an OpDiv system, product, content, or service. Assistance
may include gathering data, performing evaluations or providing
guidance.
Prior to a complaint being submitted, the nature of the complaint
must be determined. The OCR investigates complaints related to civil
rights, conscience, religious freedom, and health information privacy
at covered entities under the follow authorities:
Federal civil rights laws;
Conscience and religious freedom laws;
Health Insurance Portability and Accountability Act of 1996
(HIPAA) Privacy, Security, and Breach Notification Rules; and
Patient Safety Act and Rules.
Complaints can be filed on behalf of oneself, someone else, or an
organization. OCR complaints must be filed using OCR's Complaint Portal
Assistant. OCR's procedures will be followed and the applicable parties
will be contacted if the complaint refers to an entity within an OpDiv.
The EEO office processes complaints of employment discrimination
based on disability. Federal employees and applicants for Federal
employment who believe they have been subjected to discrimination must
contact an EEO counselor within 45 calendar days of the alleged
discriminatory action. EEO contact information can be located on the
EEO Programs and Offices website. The complaint will then follow the
EEO office's procedures until a determination is reached.
There were four section 508-related complaints processed through
OCR in the last year.
______
Questions Submitted by Hon. Maggie Hassan
Question. I have previously worked across the aisle to encourage
the Department to issue a proposed rule on transitional coverage for
emerging technologies (TCET) that addresses coverage for these
technologies and balances access with patient protections.
What is the Department's expected timeline for proposing and
finalizing a new rule?
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 has conducted 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.
Question. Vaping among children and adolescents continues to be a
major public health concern. I am particularly concerned about
disposable vapes. In 2020, the FDA announced guidance concerning
flavored vapes, but my understanding is that guidance has only applied
to flavored vapes that use a refill cartridge, and not to flavored
disposable vapes. As a result, disposable vapes have become vastly more
popular, including among children using flavored disposable vapes, as
shown in the 2022 National Youth Tobacco Survey. And it's clear that
the companies manufacturing and marketing disposable vapes are using
flavors, packaging, and tactics designed to appeal to children.
What is the administration's plan for addressing this public health
threat to our children? Will the FDA take steps to ensure that
disposable flavored vapes are treated similarly to flavored vapes that
use a refill cartridge?
Answer. Thank you for the opportunity to address this issue. I can
assure you that addressing youth use of electronic nicotine delivery
systems (ENDS), including disposable e-cigarettes, is a top priority
for the Food and Drug Administration (FDA).
FDA takes a comprehensive approach to protecting our Nation's youth
from the dangers of and access to tobacco products, including e-
cigarettes. Enforcement is an important component to FDA's multipronged
approach to regulating tobacco products that also includes review of
new products before they come to market, compliance and enforcement
actions against illegal products, regulatory policy, and public
education.
As background, FDA has regulated e-cigarettes as tobacco products
since August 8, 2016. Pursuant to the Tobacco Control Act, as of this
date, e-cigarette products generally were required to have FDA
authorization prior to marketing. For products that were already on the
market when this requirement took effect, FDA deferred enforcement for
a period of time. In January 2020, amid alarming levels of youth use of
e-cigarettes, FDA issued a final guidance for industry outlining the
agency's enforcement priorities for these products.
The final guidance included a policy prioritizing enforcement
against certain unauthorized flavored e-cigarette products that appeal
to youth.\57\ At that time, cartridge-based products, including JUUL,
were the most commonly reported product type used among U.S. youth. The
guidance also noted that FDA intended to prioritize enforcement of any
ENDS product that is offered for sale after September 9, 2020 and for
which the manufacturer did not submit a premarket application (or after
a negative action by FDA on a timely submitted application).
Importantly, the guidance noted that it did not in any way alter the
fact that it is illegal to market any new tobacco product without FDA
authorization and that FDA may adjust its enforcement priorities over
time in light of the best available data.
---------------------------------------------------------------------------
\57\ This guidance was revised in April 2020 to reflect extensions
of certain dates due to the COVID pandemic. This revised guidance is
available at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/enforcement-priorities-electronic-nicotine-delivery-
system-ends-and-other-deemed-products-market.
In September 2020, based on data from the 2020 National Youth
Tobacco Survey showing an alarming uptick in use of flavored disposable
e-cigarettes by youth, FDA announced that it has taken action to notify
companies selling such products to remove them from the market. In a
press release, FDA stated: ``As we have said many times, the FDA will
take action against any ENDS product--regardless of whether it is
cartridge-based, disposable, flavored, or otherwise--if it is targeted
to kids, if its marketing is likely to promote use by minors, or if the
manufacturer fails to take adequate measures to prevent youth access,''
and ``This new data will inform the FDA's enforcement and other
actions, and flavored disposable ENDS will be an enforcement priority
for the agency.''\58\
---------------------------------------------------------------------------
\58\ https://www.fda.gov/news-events/press-announcements/national-
survey-shows-encouraging-decline-overall-youth-e-cigarette-use-
concerning-uptick-use.
FDA has refused admission to the U.S. of disposable e-cigarettes
for violation of the Federal Food, Drug, and Cosmetic Act;\59\ issued
warning letters to retailers for illegally selling disposable e-
cigarettes to underage purchasers; and issued warning letters to
manufacturers for illegally marketing unauthorized disposable
products--including Puff Bar,\60\ which was the most commonly used e-
cigarette brand reported by youth in 2022.
---------------------------------------------------------------------------
\59\ https://www.fda.gov/news-events/press-announcements/cbp-fda-
seize-counterfeit-unauthorized-e-cigarettes.
\60\ https://www.fda.gov/news-events/press-announcements/fda-
notifies-companies-including-puff-bar-remove-flavored-disposable-e-
cigarettes-and-youth.
FDA also continues to review premarket tobacco product applications
(PMTAs) for all new deemed tobacco products, including disposable e-
cigarettes. FDA issued marketing denial orders for certain disposable
Hyde products, which was the third most commonly used e-cigarette brand
among youth in 2022. Most recently, FDA also issued marketing denial
orders (MDOs) to 10 companies, which collectively manufacture and
market approximately 6,500 flavored e-liquid and e-cigarette
products.\61\
---------------------------------------------------------------------------
\61\ https://www.fda.gov/tobacco-products/ctp-newsroom/fda-issues-
marketing-denial-orders-approximately-6500-flavored-e-cigarette-
products.
Question. On December 6, 2022, in my role as chair of the
Subcommittee on Emerging Threats and Spending Oversight of the Senate
Homeland Security and Governmental Affairs Committee, I sent a letter
to HHS Acting Chief Financial Officer Norris Cochran and Chief
Information Officer Karl Mathias regarding HHS's legacy information
technology systems. The deadline to respond was February 6, 2023, but
---------------------------------------------------------------------------
my office has not received HHS's response.
Please report on the status of the response and, if possible,
attach it as part of your response to these questions for the record.
Answer. Apologies for the delay. On April 18, 2023 HHS sent a
response letter to your staff. It is attached here and summarized
below.
We appreciate Congress's continuing efforts to modernize and secure
the information technology (IT) infrastructure across the government.
HHS shares your goals to update and improve our aging legacy systems.
HHS mainly uses the HHS Nonrecurring Expenses Fund (NEF) to meet
the objectives of the Modernizing Government Technology Act of 2017
(MGT Act), rather than an agency specific working capital fund (WCF)
for IT modernization. HHS uses the NEF for IT acquisition and
modernization consistent with the MGT Act's objectives. HHS manages
requests for IT resources through the NEF relying on the CIO and
Assistant Secretary for Financial Resources (ASFR) as critical partners
that ensure the uses of these funds support the agency mission. As part
of an integrated process, the HHS CIO determines which IT projects are
needed. The CIO review ensures critical projects receive funding before
others are considered and that unapproved requests do not proceed.
Next, ASFR determines whether the sponsoring office has alternative
funding to cover the project and if central funding from the NEF is
needed for the IT project to succeed. The combined process ensures the
proper balance of funding sources and IT resources as they support the
agency mission.
The NEF authority provided by the Committees on Appropriations
enables HHS to recycle funds that would otherwise not be available for
IT investments, by allowing HHS to transfer funds to a central account,
to remain available until expended for IT and facility investments. The
HHS IT Strategic Plan FY 2021-2023 represents the Department's ambition
to deliver its core functions with greater agility, security, and
effectiveness amidst an evolving public health landscape. The HHS IT
Strategic Plan may be found at: https://www.hhs.gov/sites/default/
files/hhs-it-strategic-plan-final-fy2021-2023.pdf.
Over the past 2 years, the Indian Health Service (IHS) has devoted
substantial effort and resources to the program and acquisition
planning phases of the agency's multi-year health information
technology modernization initiative. Key elements accomplished or under
way include:
Tribal Consultation, Urban Confer, and internal agency
analysis of the findings from the 2018-2019 joint HHS/IHS
Health IT Modernization Research Project. A final decision memo
was issued in April of 2021 committing IHS to full replacement
of the Resource and Patient Management System (RPMS) as the
most appropriate, realistic, and sustainable option for IHS
health IT modernization.
To accelerate planning and related activities, IHS engaged
the CMS Health Federally Funded Research and Development Center
(operated by the MITRE Corporation). MITRE has been working
with IHS for more than 2 years on multiple fronts, including:
Designing a Federal governance structure that
ensures ongoing consultation and confer with Tribal and urban Indian
partners as well as engagement of health IT users in building and
operational management of the new systems.
Establishing the Federal Executive Steering
Committee (ESC) and structuring the Program Management Office (PMO)
responsible for overall day-to-day management of the modernization
Program.
Establishing the critically important
Organizational Change Management (OCM) and Communications branches of
the PMO.
Conducting a thorough Life Cycle Cost Estimate
(LCCE) for health IT modernization across Indian country, in accordance
with the rigorous 12-step process published by the Government
Accountability Office.
Drafting initial concepts for infrastructure
architecture, design, and data management; these will be refined in
concert with the vendor once the contract for the modernized health IT
solution suite is awarded.
Clinical and administrative business process
and best practice consensus development, modeling, and standardization
in preparation for system transition.
Acquisition planning support.
______
Questions Submitted by Hon. Elizabeth Warren
reproductive health
Question. A Federal lawsuit is currently threatening access to
mifepristone, one of two drugs used safely and effectively in
medication abortion. Mifepristone has been FDA approved for over 2
decades and is used in more than half of abortion procedures
nationwide.
Do you agree that FDA is best suited to determine the safety and
effectiveness of drugs, including mifepristone?
Answer. Yes. Congress has charged FDA with determining the safety
and effectiveness of drugs. And I have confidence in the FDA staff, who
rely on the best available scientific evidence to determine the safety
and effectiveness of drugs, and I will continue to defend the FDA's
independent, expert authority to review, approve, and regulate a wide
range of prescription drugs.
Question. Based on FDA's analysis, which includes review of
information from multiple scientific and medical professional
societies, do you agree that medication abortion is a safe option for
patients to end an early pregnancy?
Answer. The FDA approved Mifeprex (mifepristone 200 mg) more than
20 years ago based on a thorough and comprehensive review of the
scientific evidence presented and determined that it was safe and
effective for medical termination of early pregnancy. Since 2016, it
has been approved for medical termination of pregnancy through 70 days
gestation. In this area, as in all others FDA regulates, the best
available science has guided agency decision-making.
Taking mifepristone off the market would significantly compromise
access across the country--including in California, Illinois, New York,
and other States that have secured abortion access.
Question. What is HHS doing to protect access to medication
abortion?
Answer. The Biden-Harris administration is committed to protecting
access to reproductive health care and has taken several steps to
advance this work. Just hours after the Supreme Court's decision in
Dobbs was released, the Department put up the website
reproductiverights.gov to help ensure that people had a fact-based
website with information on their rights and where they can get
coverage for family planning care and birth control. And, based on a
comprehensive review of the Mifepristone Risk Evaluation and Mitigation
Strategy (REMS) Program, in January 2023 the FDA approved modifications
to the REMS so that Mifepristone is no longer required to be dispensed
in-person. In addition, the FDA eliminated the previous REMS
requirement that did not allow the drug to be dispensed by retail
pharmacies; under the REMS, any pharmacy that meets the requirements,
and is certified, may dispense mifepristone based on a prescription
from a certified prescriber. Protecting access to safe and effective
medication abortion is a top priority for me.
Medicaid's free choice of provider requirement is a critical
protection that ensures Medicaid beneficiaries can access sexual and
reproductive health care at the provider of their choice, including
Planned Parenthood. As you know, we have witnessed a disturbing trend
in recent years, as hostile Republican Governors and State legislatures
have taken action to deny Medicaid patients their Federal legal right
to seek services from the provider of their choice. Several States--
Missouri, Arkansas, Mississippi, Texas, Louisiana, and South Carolina--
have violated this longstanding requirement. These State violations
delay and impede timely access to essential services: birth control,
sexually transmitted infection testing and treatment, gender-affirming
care, annual wellness exams, and other essential care. These violations
also disproportionately impact people and women of color, who, due to
racism and other systemic barriers that have contributed to income
inequality, are more likely to use Medicaid for coverage.
I recently sent a letter highlighting a number of important steps
to protect access to reproductive health care, including enforcement of
this critical Federal protection, as part of the ongoing response to
the Supreme Court's devastating decision in Dobbs.
Question. What is HHS's plan to protect everyone's right to access
services like birth control, STI testing and treatment, and gender-
affirming care at the provider of their choice?
Answer. The Biden-Harris administration is committed to ensuring
access to health care and has taken several steps to advance this work.
Just hours after the Supreme Court's decision in Dobbs was released,
the Department published the website reproductiverights.gov to help
ensure that people had a fact-based website with information about
their rights and where they can obtain coverage for family planning
care and birth control. The Department also worked to help ensure that
people could continue to access birth control through private insurance
markets and other Federal programs. Additionally, on July 13, 2022, HHS
issued guidance to roughly 60,000 U.S. retail pharmacies, reminding
them of their obligations under Federal civil rights laws. This issue
is a top priority for me, and one I have tasked the entire Department
with taking immediate action to address.
organ procurement
Question. Last week HHS announced transformative reforms to break
up UNOS's fatal monopoly over the United States organ procurement and
transplantation network (OPTN) through HRSA's Organ Procurement and
Transplantation Modernization Initiative. OPTN failures also resulted
from severe and undisclosed conflicts among organ donation industry
stakeholders who served on OPTN boards and committees.
What specific steps will HHS (including CMS and HRSA) take to
ensure that, going forward, any stakeholder serving in any board,
advisory, or other capacity in OPTN or Scientific Registry of
Transplant Recipients policymaking or oversight fully discloses all
financial conflicts of interest, including but not limited to financial
relationships with the OPTN, OPOs, tissue recovery and processing
companies, organ logistics and transportation companies, or any other
organization which does business related to organ donation or
transplantation?
Answer. The Organ Procurement Transplantation Network (OPTN)
develops and implements policies approved by the OPTN board of
directors. On March 22, 2023, HHS announced a multiyear OPTN
modernization initiative designed to improve effectiveness across the
organ donation, procurement, and transplantation system. The
President's budget for Fiscal Year 2024 would more than double HRSA's
budget for organ-related work, including OPTN contracting and the
implementation of the modernization initiative, to total $67 million.
The initiative is intended to strengthen accountability, equity, and
performance in the organ donation and transplantation system through a
focus on five key areas with the following goals:
Technology--ensure that the system is reliable, secure,
patient-centered, user-friendly, and reflective of modern
technology functionality. There is a continuous focus on
improved IT system functionality and security, while ensuring
continuity of services, protecting patient safety, and
accelerating innovation in line with industry-leading
standards.
Data Transparency and Analytics--ensure data is accessible,
user-friendly, and patient-oriented. The modernization process
provides easily accessible, high-quality, and timely data to
make informed patient, donor, and clinical decisions; measure
and evaluate program performance; inform oversight and
compliance activities; and support the advancement of
scientific research.
Governance--the OPTN board of directors is high-functioning
and has greater independence; represents the diversity of
communities; and delivers effective policy development.
Operations--the OPTN is effective and accountable in its
implementation of organ policy, patient safety and compliance
monitoring, organ transport, OPTN member support, and education
of patients, families, and the public.
Quality Improvement and Innovation--the OPTN promotes a
culture of quality improvement and innovation across the
network by leveraging timely data and performance feedback,
collaborative learning, and strategic partnerships.
The Health Resources and Services Administration (HRSA) has been
working to make improvements with these goals in mind. In July 2022,
the Scientific Registry of Transplant Recipients convened a consensus
conference to make recommendations for better metrics to support organ
donation and transplantation and in March 2023, HRSA released an OPTN
organ transplantation dashboard to improve transparency of data to the
public. Fall 2023 and Spring 2024 OPTN contract solicitations are an
opportunity for further advancements in transparency, such as a
requirement of the OPTN contractor to improve patient and family
understanding of waitlist practices.
As part of the modernization initiative, HRSA will continue to
strengthen OPTN contract requirements to ensure members of the OPTN
board of directors are separate from OPTN contractor's board. Further,
the Fall 2023 OPTN contract solicitation will enable multiple vendors
to compete for distinct OPTN functions and will require establishment
of an independent OPTN board of directors free from conflicts of
interest.
HRSA requires the OPTN board of directors and the Scientific
Registry of Transplant Recipients Review Committee members to complete
training and sign annual attestations to mitigate conflict of interest
concerns and ensure that financial relationships are disclosed.
HRSA will continue to focus on meeting the needs of patients and
families by strengthening and providing equitable access to
transplantation, improving safety and health outcomes, and empowering
patients and providers with the data needed to make informed, shared
decisions.
To ensure fair and open competition for the OPTN contract, it is
imperative that HHS not allow UNOS or its surrogates to interfere with
the business and operations of other potentially interested bidders,
including through retaliation or harassment against patients, doctors,
caregivers, or other stakeholders interested in supporting competitive
bids.
Question. What specific steps will HHS commit to taking to
investigate any and all such allegations, and to remove from all OPTN
activities anyone found to be involved in such retaliation and
harassment?
How will HHS/HRSA ensure that taxpayer resources--including those
that have accumulated at UNOS due to both HRSA appropriations as well
as OPTN and UNOS fees, which were funded by taxpayers via Medicare as
well as other parts of government--are not used to fund either UNOS's
bid for component pieces of the OPTN contract, acquisition of any
potential competitors, or its extensive marketing and lobbying
activities?
Answer. In the upcoming Request for Proposals (RFP), HHS, through
HRSA, will follow all Federal contract policies to ensure that there is
equal opportunity for eligible vendors. HRSA also is committed to
accountability and intends to work closely with the HHS Office of the
Inspector General and others in response to any allegations that
warrant such action.
child care
Question. Early education expands learning opportunities for our
babies and gives parents an opportunity to go to work. But the United
States has been underinvesting in child care for decades. Of the 37
richest nations in the world, the U.S. is now number 33 in our spending
on our little ones.\62\
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\62\ The Organisation for Economic Co-operation and Development,
``Public spending on childcare and early education,'' OECD Family
Database, https://www.oecd.org/els/soc/
PF3_1_Public_spending_on_childcare_and_early_education.pdf.
Yet, House Republicans are demanding across-the-board funding
cuts--at least 27 percent to all government programs.\63\ If defense,
veterans, Social Security, and Medicare are off the table--as some
Republicans now claim--other programs would need to be cut by 78
percent.\64\ That includes funding for Head Start and other crucial
child-care programs.
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\63\ Committee for a Responsible Budget, ``What Would It Take to
Balance the Budget? An Update,'' February 24, 2023, https://
www.crfb.org/blogs/what-would-it-take-balance-budget-update.
\64\ Id.
You have previously stated that a return to FY 2022 enacted funding
levels for Head Start would result in a loss of at least 170,000 slots
for children, and a 22-percent reduction in funding from FY 2023 would
eliminate over 200,000 slots.\65\ How many slots would be lost if Head
Start funding were cut by 27 percent? 78 percent?
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\65\ Department of Health and Human Services, Letter to
Representative DeLauro, March 17, 2023, https://democrats-
appropriations.house.gov/sites/democrats.appropriations.house.gov/
files/Department%20of%20Health%20and%20Human%20Services%20Letter%20-
%20Impact%20
of%20Spending%20Cuts.pdf.
Answer. Reducing funding for Head Start by 27 percent would
eliminate nearly 250,000 slots for children. A 78-percent cut would
result in a loss of more than 600,000 slots. With a 78-percent cut, OHS
would expect that many programs--particularly Tribal, rural, and
smaller programs--would need to close because their programs would no
longer be viable due to very small size and they would no longer be
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able to cover fixed operating costs such as rent.
Question. You have also stated that a return to FY 2022 enacted
funding levels would result in a loss of at least 105,000 child-care
slots, down from 1,843,000 in FY 2023.\66\ And a 22-percent reduction
in funding from FY 2023 would eliminate over 101,000 slots.\67\ How
many slots would be lost if child-care funding were cut by 27 percent?
78 percent?
---------------------------------------------------------------------------
\66\ Id.
\67\ Id.
What would the impacts of these funding cuts mean for parents,
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families, and children losing access to care?
Answer. Even with the 30-percent increase Congress appropriated to
the Child Care and Development Block Grant (CCDBG) in FY 2023, the
child-care subsidy system is only funded to serve a small fraction of
eligible families to be served--historically supporting just one in
seven of those children who are eligible for child-care assistance.
Future funding cuts to CCDBG would result in States reducing the number
of families who receive child-care assistance. Funding cuts will also
undermine parent choice in care, making it even more difficult for
parents to find child care that meets their family's needs. Reducing
child-care assistance will also harm employment and family economic
stability. In some areas of the country, child-care costs can exceed
the cost of college tuition.\68\ When families are unable to access
child-care subsidies, they may have to patch together less expensive
care that could lead to informal, unregulated care that is less
reliable, less likely to meet children's developmental needs and to
families cutting work hours or exiting the workforce entirely. It's
estimated that U.S. parents collectively lose $30 to $35 billion in
income due to reducing their work or leaving the workforce entirely
when they cannot find affordable child care.\69\
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\68\ Example of a local DC private-pay program tuition rate of
$20,400 per school year/not including summer months for a 2-year-old
for care from 8:30 a.m. to 2:30 p.m. (which does not cover the full
work day for a parent). This is a typical, real-life example in
Washington, DC; https://stcolumbasnurseryschool.org/program-tuition/.
\69\ https://www.ffyf.org/our-child-care-system-is-not-meeting-the-
needs-of-families-providers-or-the-economy/.
Question. The Child Care Stabilization Grants provided in the
American Rescue Plan Act (Pub. L. 117-2) provided crucial relief during
the COVID-19 pandemic to allow child-care centers to remain open.
However, the expiration of this funding is rapidly approaching, with
States facing a funding cliff of over $48 billion.\70\ How will the end
of this relief funding, coupled with proposed cuts to annual child-care
funding affect the child-care industry? What would the impact be on the
child-care workforce, which is still down about 60,000 workers compared
to pre-pandemic?\71\ How many families would lose access to child care?
What would the impact be on fees and affordability?
---------------------------------------------------------------------------
\70\ Bipartisan Policy Center, ``States Face a $48 Billion Child
Care Funding Cliff,'' Linda Smith and Victoria Owens, June 3, 2022,
https://bipartisanpolicy.org/blog/states-face-a-48-billion-child-care-
funding-cliff/
#::text=T%20hroughout%20the%20pandemic%2C%20Congress,fiscal%20
cliff%20of%20%2448%20billion.
\71\ The Wall Street Journal, ``Pricey Child Care Is Keeping Many
Parents Out of the Workforce,'' Harriet Torry, March 18, 2023, https://
www.wsj.com/articles/pricey-child-care-is-keeping-many-parents-out-of-
the-workforce-1923f4dd.
Answer. ARP and other COVID child-care funding has been critical to
stabilizing the child-care sector, lowering parent costs, and raising
child-care staff compensation. The end of these funds coupled with
additional cuts to the CCDF program will harm many children and
families. Child-care programs need consistent revenue and financial
support to be able to improve quality or raise chronically low wages
for the child-care workforce to address high employee turnover and
staff shortages. Some States have used ARP funds to pay bonuses or
increase salaries, but providers say they still struggle to find staff,
and it is uncertain whether these practices will be continued after ARP
stabilization funds expire. Due to the staffing shortages, there are
providers currently reporting they are hiring people who they would not
have even considered for a position prior to the COVID-19 pandemic
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because of lack of skill, training, or competence.
Additionally, families will lose access to subsidies just as ARP
stabilization payments are no longer available to support child-care
providers directly. A Kentucky child-care provider recently shared what
this means for her business and the families she serves. Before the
COVID-19 pandemic, she served two to five children who received a
child-care subsidy. Currently, 19 children in her program receive a
subsidy, but only for the remainder of this eligibility year. Once ARP
stabilization payments to providers expire, the provider expects she
will need to raise tuition up to 70 percent to remain open and keep
staff. This means the cost to families will increase just as they are
losing access to subsidies.
drug pricing
Question. After more than 480 days, the National Institutes of
Health (NIH) responded to the petition sent to you by prostate cancer
patients Robert Sachs and Clare Love, formally asking HHS to grant
march-in rights for the patents on the prostate cancer drug
enzalutamide (marketed as Xtandi). The patients' petition referenced a
previous request to the Department of Defense (DOD) for it to use
march-in rights, as well as the nonexclusive, nontransferable,
irrevocable, paid-up licenses held by the U.S. Government to use the
enzalutamide patents, to which the DOD never responded.
The response from the NIH to the petition sent to you completely
ignored the petitioners' argument that, by definition, meeting
practical application requirements under the Bayh-Dole Act requires
that the invention at issue is ``available to the public on reasonable
terms.'' I object to HHS, through NIH, continuing to ignore this vital
taxpayer protection.
While it is my strongly held view that a prescription drug
corporation charging U.S. patients and taxpayers 3-6 times the prices
it charges in other wealthy countries for a drug that U.S. taxpayers
paid to invent through grants from the NIH constitutes sufficient
grounds for exercising march-in rights, the royalty-free right,
provided under 35 U.S.C. 202(c)(4), is not subject to practical
application or other march-in rights prerequisites. Additionally, the
royalty-free right is not subject to appeal before the United States
Court of Federal Claims or to being held in abeyance during such an
appeal.
Currently, four companies have filed ANDA applications, two of
which have already received tentative approval from FDA for generic
versions of enzalutamide. Through HHS exercising its royalty-free
rights, these manufacturers could readily supply Federal health
programs, including Medicare and Medicaid, for a fraction of the price
charged by Astellas, saving taxpayers billions of dollars over the
remaining patent life of enzalutamide.
Has your office considered exercising the royalty-free rights held
by HHS for enzalutamide? If so, what determinations have you made and
under what rationale? If not, why not?
Answer. I assure you that HHS and the Biden-Harris administration
remain steadfastly committed to increasing all Americans' access to
health care and lowering costs for lifesaving treatments and cures.
In support of President Biden's Executive Order on Lowering
Prescription Drug Costs for Americans (https://www.whitehouse.gov/
briefing-room/presidential-actions/2022/10/14/executive-order-on-
lowering-prescription-drug-costs-for-americans/), HHS is pursuing a
whole-of-government approach to build on this administration's
priorities. As you noted, an important step towards this goal was the
passage and signing of the Inflation Reduction Act, which will reduce
prescription drug costs for the more than 63 million individuals with
Medicare. In addition, the Centers for Medicare and Medicaid Services
recently issued initial guidance detailing the requirements and
procedures for implementing the new Medicare Drug Price Negotiation
Program for the first set of negotiations. The first set of
negotiations will occur during 2023 and 2024 and result in prices
effective in 2026. The guidance details how Medicare intends to use its
new authority to effectively negotiate with drug companies for lower
prices on selected high-expenditure drugs, and illustrates the Biden-
Harris administration's commitment to lowering high prescription drug
costs and improving access to innovative therapies. CMS anticipates
issuing revised guidance for the first year of negotiation in Summer
2023.
We know more must be done as too many Americans, particularly the
uninsured, find these therapies to be out of reach. March-in authority
is indeed a powerful tool designed to ensure that the benefits of the
American taxpayer's investment in research and development are
reasonably accessible to the public. HHS, the National Institutes of
Health (NIH), and other agencies have been petitioned on several
occasions to initiate march-in proceedings, but to date have not
invoked this authority. Most recently, NIH declined to initiate a
march-in proceeding, at the petition of a third party, for the prostate
cancer drug Xtandi. In the case of Xtandi, NIH thoroughly reviewed the
petition in a manner consistent with the policy and objectives of the
Bayh-Dole Act, including an assessment of the relevant intellectual
property and applicability of the four statutory criteria. NIH's
analyses found Xtandi to be widely available to the public on the
market. In addition, given the remaining patent life and the lengthy
administrative process involved for a march-in proceeding, NIH did not
believe that use of the march-in authority would be an effective means
of lowering the price of the drug. For these reasons, NIH determined
that initiation of a march-in proceeding was not warranted in this case
and HHS concurs with NIH's decision. This decision is consistent with
NIH's determination in 2016 in which Knowledge Ecology International
and the Union for Affordable Cancer Treatment requested that NIH and
the Department of Defense initiate march-in proceedings based on the
price of Xtandi, but each declined.
We recognize, however, that there is a need to evaluate how pricing
may be a contributing factor when weighing the use of the march-in
authority and have committed to working with the Department of Commerce
to review the use of march-in authority as laid out in the Bayh-Dole
Act. Through this partnership, we have asked an Interagency Working
Group to develop a framework for consistent implementation of the
march-in provision across the U.S. Government that clearly articulates
guiding criteria and processes for making determinations where
different factors, including price, may be a consideration in agencies'
assessments. HHS will convene a workshop in 2023 to further refine the
cases for which HHS could consider exercising march-in authority. HHS
will seek input from a diverse array of stakeholders--including patient
groups, industry, universities, small business firms, and nonprofit
organizations, as well as experts in technology transfer and innovation
policy. The goal of the workshop will be to assess when the use of
march-in rights is consistent with the policy and objectives of the
Bayh-Dole Act.
unique device identifiers
Question. Although medical device failures are rare, when they do
occur, they can create serious health problems and significant
financial costs. A 2017 investigation by the Office of Inspector
General at the Department of Health and Human Services found that
recalls or premature failures of just seven faulty cardiac devices
resulted in $1.5 billion in Medicare payments and $140 million in out-
of-pocket costs to beneficiaries. Furthermore, the Inspector General
was not able to examine the total cost of all device failures because
of the lack of information about specific devices in claims data.
Instead, OIG examiners were forced to engage in a ``complex and labor-
intensive audit'' to assess the impact of the seven faulty devices. As
a result, the OIG recommended that CMS add unique device identifiers
(UDIs) to Medicare claims. Including device identifiers on claims
transactions would greatly improve the health system's ability to
identify risks and reach patients who may be affected by device
failures.
The process of adding UDIs to Medicare claims is a complex one, but
ultimately will require CMS to agree to act on the recommendations of
X12, an entity that establishes accredited standards for claims
transactions. In June, X12 formally recommended that the device
identifier portion of a medical device's UDI be included on the
electronic claims transaction. Now, the National Committee on Vital and
Health Statistics, an HHS advisory body, must assess the recommendation
and make an official recommendation to HHS for adoption.
Will you commit to implementing X12's recommendation and adding
UDIs to Medicare claims in a timely manner?
Answer. While the benefits of UDI adoption in health care are well
known, as you noted, for any portion of the UDI to be included in
Medicare claims, the American National Standard Institute's Accredited
Standards Committee (X12) must first submit formal recommendations on
the proposed health-care claims transaction standards to the National
Committee on Vital and Health Statistics (NCVHS). NCVHS must then,
after assessing the recommendations, officially recommend to the
Department that it should adopt the standards. Finally, the
Department's adoption of new standards would still have to be completed
through notice and comment rulemaking. The X12 committee has made
recommendations to include collection of the DI for high-risk
implantable devices, between willing trading partners, in the next
version of the claim transactions standards. The Department will have
the opportunity to address this issue after we receive the NCVHS
recommendations for the next version of the standard transactions.
______
Questions Submitted by Hon. Chuck Grassley
Question. Value-based health-care efforts are important to bending
the cost curve of our Nation's health-care spending. In 2019, CBO
stated ``the available evidence indicates that ACOs have had little or
no net effect on Medicare spending.'' Since then, CBO has communicated
they monitor ``official evaluations of ACOs from the Center for
Medicare and Medicaid Innovation (CMMI) as well as academic research
about the performance of ACOs. Since the agency's statement in March
2019 and December 2020 QFRs, CBO's review of the evidence continues to
indicate that ACOs have had little or no net effect on Medicare
spending.'' What is the Office of the Actuary at CMS's independent
actuarially sound estimate for combined Medicare and Medicaid
unrealized savings to the Federal Government from ACOs since the ACA
was implemented? Does the administration assume any of the actuarially
sound estimate into its mandatory health spending outlays?
Answer. The Medicare Shared Savings Program, through its work with
Accountable Care Organizations (ACOs) saved Medicare $1.66 billion in
2021 compared to spending targets. This marks the 5th consecutive year
the program has generated overall savings and high-quality performance
results. Over the past decade, the Shared Savings Program has grown to
one of the largest value-based purchasing programs in the country.
Other ACO models in the Innovation Center have also been found to
produce Medicare savings. In particular, the Pioneer ACO Model, which
operated from 2012 through 2016, was evaluated to have saved $384
million over the first 2 performance years ($254 million in net
savings) and was certified for expansion by the Chief Actuary of CMS in
2015 because expansion was expected to reduce net Medicare spending. In
that certification, the Chief Actuary noted that ``[b]oth the Pioneer
and MSSP ACOs have been shown to produce savings relative to fee-for-
service Medicare.'' In addition, the ACO Investment Model, which
operated from 2015 through 2018, was evaluated to have saved $526.4
million in Medicare spending across 3 performance years ($381.5 million
in net savings). Elements of both models were subsequently incorporated
into the Shared Savings Program through rulemaking. Based on these
successes and opportunities to continually improve value for people
with Medicare and the health-care system, CMS has set a goal that 100
percent of people with traditional Medicare will be part of an
accountable care relationship by 2030.
Financial and quality data for participants in the Medicare Shared
Savings Program is publicly available at https://www.cms.gov/medicare/
payment/fee-for-service-providers/shared-savings-program-ssp-acos.
Evaluations of Innovation Center Models can be found at https://
www.cms.gov/priorities/innovation/overview.
Question. The President's budget seeks to permanently extend
enhanced premium tax credits for high-income earners beyond 2025. The
budget proposal indicates permanently extending enhanced premium tax
credits costs $183 billion over 10 years. CBO has estimated making the
subsidies permanent would result in a 2.3 million decrease in
enrollment in employment-based coverage. What actions is the
administration taking to expand other high-quality, consumer-protected
affordable health-care options, including employer-based coverage
options, that do not cost the taxpayers anywhere near $183 billion over
10 years?
Answer. Ensuring that all Americans have access to quality,
affordable health care is one of the Biden-Harris administration's top
priorities, and HHS has numerous efforts underway to help achieve this
goal. The enhanced premium tax credits contributed to a record-setting
16.3 million people enrolling in marketplace coverage in 2023. The
President's budget also lowers costs for families with private health
coverage by capping insulin costs at $35 for a monthly prescription and
extending Medicare drug inflation rebates to commercial plans. In
December 2022, CMS released the 2024 Notice of Benefit and Payment
Parameters Proposed Rule, which would increase access to health-care
services, simplify choice and improve the plan selection process, and
make it easier for consumers to enroll in coverage. As required by law,
CMS sought public comment on the proposed rule and will take this
feedback into account when finalizing the Notice of Benefit and Payment
Parameters. CMS received a large number of comments in response to the
proposed rule and appreciates the commenters' thoughts and input
regarding standards for issuers and marketplaces, as well as
requirements for agents, brokers, web-brokers, and assisters that help
consumers with enrollment through marketplaces that use the Federal
platform.
Question. In February, CMS finalized the Medicare Advantage Risk
Adjustment Data Validation (RADV) rule with the goal ``to improve
program integrity and payment accuracy.'' I've written to CMS in 2015
and 2017 asking what they are doing to implement safeguards to reduce
risk score fraud, waste, and abuse. In the final rule, CMS plans to
only attempt to collect $41.1 million in non-extrapolated improper
payments from 2011 to 2017, instead of approximately $2 billion in
extrapolated improper payments over the same time period. In explaining
this decision, CMS cited ``certain operational considerations.''
Please provide a detailed list of those ``certain operational
considerations'' and their associated costs to the Federal Government
to perform.
In 2015, CMS noted to me that it recovered $1.5 billion from 2006
to 2013 in ``report and pay'' recoveries from Medicare Advantage
organizations. The proposed RADV rule stated it would collect $4.5
billion over 10 years. Your agency's final rule goes into great detail
about the repeated delay of RADV audits. Your agency estimates in its
final rule that it will collect $4.7 billion in overpayments over a 10-
year period. Given the agency's track record on RADV overpayment
auditing and the delay of this final rule, what assurances can the
agency provide that it will meet the estimates for collections in the
next 10 years?
CMS has previously stated to me that its RADV audit process for
each calendar year was at various stages of review and completion.
Please provide a status update and expected timeline for Medicare
Advantage overpayment audits by calendar year from 2011 through 2022.
Answer. On February 1st, CMS published a final rule that finalized
the policies for the Medicare Advantage (MA) Risk Adjustment Data
Validation (RADV) program, which is CMS's primary audit and oversight
tool of MA program payments. In addition to the CMS RADV audits, the
HHS Office of the Inspector General (OIG) also undertakes audits of
MAOs, similar to RADV audits, as part of its oversight functions. CMS
can collect the improper payments identified during those HHS-OIG
audits, including the extrapolated amounts calculated by the HHS-OIG.
The policies in the RADV final rule will help protect the Medicare
Advantage program by addressing instances where Medicare paid Medicare
Advantage Organizations (MAOs) more than they otherwise should have
received because the medical diagnoses submitted for risk adjustment
payment were not supported in the beneficiary's medical record.
Specifically, this final rule codifies in regulation that, as part of
the RADV audit methodology, CMS will extrapolate RADV audit findings
beginning with payment year (PY) 2018. As a result, CMS will only
collect the non-extrapolated overpayments identified in the CMS RADV
audits and HHS-OIG audits between PY 2011 and PY 2017, and will begin
the collection of extrapolated overpayment findings for any CMS and
HHS-OIG audits conducted in PY 2018 and any subsequent payment year.
We believe this is an appropriate policy because it recognizes our
fiduciary duty to protect taxpayer dollars from overpayments and
preserves our ability to collect on potentially significant amounts of
overpayments made to plans beginning in PY 2018 using an extrapolation
methodology. This final rule will also allow CMS to focus on conducting
future RADV audits as soon as practicable after an MAO payment year
concludes, which was the topic of significant public comment to the
proposed rule. Lastly, we have determined that it is in the best
interest of all parties to ensure that the contract-level RADV appeals
process, which is also referenced in regulation, is able to
successfully process all RADV appeals. By not using an extrapolation
methodology prior to PY 2018, we expect to better control the total
number of active appeals that are submitted in the first few years
following finalization of this rule, which will alleviate burden on
MAOs and CMS.
When this rule is finalized, we will begin issuing the enrollee-
level audit findings from the CMS RADV audits that have been completed
(that is, CMS RADV audits for PY 2011-2013, followed eventually by PY
2014 and PY 2015 audits), as well as recovering enrollee-level improper
payments identified in HHS-OIG completed RADV audits. The plans for
future audit years will be communicated to the MAOs through our
standard channels.
Question. HHS recently posted a Notice of Proposed Rulemaking that
would allow States to maintain different standards to license non-
relative foster parents and kinship care providers, with the goal of
reducing barriers for relatives to provide care to children who are in
need of foster care. Will ACF issue guidance to States on how decisions
related to non-safety related standards for kinship providers could
also be applied to non-relative foster parents to reduce barriers to
licensing?
Answer. While title IV-E of the act specifically allows title IV-E
agencies to waive non-safety licensing standards for relative foster
family homes (see section 471(a)(10)(D) of the act), there is no
similar waiver for non-related foster family homes. Therefore, ACF
cannot provide guidance on how to waive those standards for non-related
foster family homes. Subject to the requirements for title IV-E
eligibility, State licensing standards for foster homes, whether
related or non-related homes, are generally a State issue. ACF is happy
to work with States that are interested in exploring potential changes
to their State licensing standards to reduce barriers to licensing, but
ACF does not generally oversee State licensing standards.
Question. HHS recently posted a Notice of Proposed Rulemaking that
would allow States to maintain different standards to license non-
relative foster parents and kinship care providers, with the goal of
reducing barriers for relatives to provide care to children who are in
need of foster care. The definition of kinship provider can include
non-relatives who have an existing connection to a child. For the
purpose of this rulemaking, how will ACF instruct States to consider
licensing for relatives compared to non-relative, ``fictive kin?''
Answer. As stated in the February 2023 NPRM, title IV-E agencies
have discretion to define ``relative'' and ``kin'' when determining to
whom they will apply the relative licensing and approval standards. ACF
is currently reviewing and analyzing public comments on the Notice of
Proposed Rulemaking. The Department has not yet determined how the
final rule will respond to the committee's question.
Question. The Fiscal Year 2024 budget request includes a request to
make permanent a temporary provision allowing 50 percent of States'
spending on prevention services under the Family First Prevention
Services Act to be spent on programs that are rated as well-supported
or supported, rather than only well-supported programs. This temporary
provision was enacted in 2019 when the Prevention Services
Clearinghouse was newly created and there was an extremely limited
number of well-supported programs. In your view, how many well-
supported programs would need to be listed on the Prevention Services
Clearinghouse to return to the original requirement of the Family First
Prevention Services Act? Is HHS concerned that supported programs may
not be as effective in accomplishing the goals of preventing foster
care placement and ensuring child safety and well-being compared to
well-supported programs?
Answer. The title IV-E Prevention Services Program, created by the
Family First Prevention Services Act (FFPSA), provides a watershed
opportunity to create more equitable and positive outcomes for
children, youth, and families before they face the tumult and
devastating consequences of maltreatment and separation. Working with
State and Tribal partners, we are seeking to expand participation in
the program and to ensure that agencies are able to offer effective
services to meet the needs of all communities and families and we are
making progress:
To date, the Prevention Services Clearinghouse has reviewed
141 programs and services; 17 of these have been rated as well-
supported, 18 of these have been rated as supported, and 36 of
these have been rated as promising.
The 42 approved State, jurisdiction, and Tribal title IV-E
prevention program plans to date have identified 13 well-
supported, 5 supported, and 5 promising evidence-based programs
(EBPs) and services for reimbursement in the delivery of
prevention services.
It is difficult to determine how many well-supported programs are
necessary to address and serve the breadth of issues that children and
families present when coming into contact with State child welfare
systems. We know from State child welfare agencies that families are
bringing high level, complex service needs that often require a more
tailored approach to effectively serving each family. Programs and
services that carry a promising or supported rating are required to
undergo ongoing evaluation in an effort to increase their level of
evidence to support a well-supported rating. At this time, we believe
it is in the best interest of children and families to provide as wide
a range of evidence-based/informed services as possible and to
capitalize on all available levers for building evidence.
Question. HHS and the Department of Agriculture have now twice
failed to follow the recommendations of a 2017 report from the National
Academies of Science, Engineering, and Medicine (NASEM), requested by
Congress to evaluate the Dietary Guidelines for Americans development
process--which explicitly recommended releasing ``any known conflicts--
for a reasonable period of time prior to appointment.'' It is troubling
that this recommendation was not implemented in the last two advisory
committee selection processes, not to mention the failure to implement
several other NASEM recommended reforms designed to bolster
transparency.
Will you commit to making any known conflicts of interest reviewed
during the selection process public?
In the past, the departments cited privacy concerns for potential
nominees to justify their decision not to publicly disclose any known
conflicts. If the departments continue to refuse to make public this
information, do the departments plan to develop an alternative method
for disclosing committee members' conflicts of interest following
appointment?
Answer. HHS and USDA have developed procedures to ensure that the
advice and recommendations of the Dietary Guidelines Advisory Committee
will be the result of the committee's independent judgement and not be
inappropriately influenced by the appointing authority or by any
special interest group.\72\ The FACA statute and FACA regulations are
followed throughout the selection process to ensure that the interests
and affiliations of committee members are reviewed for conformance with
applicable conflicts-of-interest statutes and regulations and to ensure
that committee membership is fairly balanced in terms of points of view
represented and functions to be performed. The members of the committee
are appointed as special government employees (SGEs). All SGEs have a
fiduciary responsibility to the Federal Government and must follow
comprehensive Federal ethics laws, including the criminal conflicts of
interest and financial disclosure reporting laws, and the Standards of
Ethical Conduct for Employees of the executive branch. All SGEs must
comply with the financial disclosure requirements found in the U.S.
Office of Government Ethics (OGE) regulations.\73\ Accordingly,
committee members are required to file an OGE 450, Confidential
Financial Disclosure Report. All members of the committee file an OGE
450 prior to appointment and continue to submit one annually throughout
their service on the committee.
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\72\ 5 U.S.C. Sec. 1004(b)(3); 41 CFR Sec. 102-3.105(g).
\73\ 5 CFR Sec. 2634, Subpart I.
The executive branch Confidential Financial Disclosure Reports (OGE
450s) and information contained therein, filed by SGEs, are
confidential pursuant to section 107(a) of the Ethics in Government
Act, 5 U.S.C. chapter 131, and section[s] 201(d) [and 502(b)] of
Executive Order 12674, as modified; see also 5 CFR Sec. Sec. 2634.604
and 2634.901(d) of the OGE regulations thereunder. Furthermore, the
reports are subject to appropriate protections under the Privacy Act, 5
U.S.C. Sec. 552a, as they constitute personal information and are
contained in the OGE/GOVT-2 system of records. Additionally, these
reports are further protected from disclosure under the Freedom of
Information Act (FOIA). In addition to the FOIA exemption, providing
for nondisclosure of such information, which is specifically exempted
by disclosure by statute, these reports are excluded from required
public disclosure under the additional FOIA exemptions for sensitive
commercial and financial information and for personal privacy-protected
information. See 5 U.S.C. Sec. Sec. 552(b)(3), (b)(4) and (b)(6). HHS
complies with the public disclosure requirements of the Ethics in
Government Act, including interpretative guidance from the Department
of Justice. Information submitted to HHS in connection with a
nomination or application for membership on a Federal advisory
committee is in an HHS system of records protected by the Privacy Act.
The Privacy Act permits disclosure of information from such systems
with the consent of the records subject, but in the absence of consent,
the agency may only disclose protected records under specific
circumstances set forth in the Privacy Act.\74\
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\74\ 5 U.S.C. Sec. 552a(b).
Question. As I stated in my opening comments at the hearing, I
thank you for enabling transitional health plans to continue.
Approximately 65,000 Iowans are benefiting from this action with many
being farmers and small business owners. Letting transitional health
plans continue has been a bipartisan priority under Presidents Obama,
Trump, and now Biden. The March 23, 2022, bulletin from CMS permitted
the nonenforcement policy for CY 2023 and it states the nonenforcement
``will remain in effect until CMS announces that all such coverage must
come into compliance with the specified requirements.'' While the
nonenforcement creates regulatory certainty in CY 2023, it actually
creates uncertainty in CY 2024 and subsequent years. Your answer on
this topic to my FY 2023 Health and Human Services budget question for
the record stated, ``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 nonenforcement 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.'' Given you didn't
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answer my questions in 2022, I will restate my questions below.
What standard will CMS apply in taking regulatory action to permit
transitional health plans to be sold in CY 2024 and subsequent years?
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 nonenforcement 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.
Question. As of March 11, 2023, according to the Rural Health
Redesign Center that is serving as the Rural Emergency Hospital
Technical Assistance Center, more than 50 hospitals and other
organizations have expressed interest in becoming a Rural Emergency
Hospital (REH), a new voluntary Medicare designation that provides a
lifeline to ensure access to rural health-care services. How many
applications has HHS/CMS received from hospitals expressing intent on
becoming an REH? How many applications have been approved by HHS/CMS?
Answer. Rural Emergency Hospitals (REHs) are a new provider type
established by the Consolidated Appropriations Act, 2021 to address the
growing concern over closures of rural hospitals. The REH designation
provides an opportunity for Critical Access Hospitals and certain rural
hospitals to avert potential closure and continue to provide essential
services for the communities they serve. Conversion to an REH allows
for the provision of emergency services, observation care, and
additional medical and health outpatient services, if elected by the
REH, that do not exceed an annual per patient average of 24 hours. This
new provider type, effective January 1, 2023 will promote equity in
health care for those living in rural communities by facilitating
access to needed services. Eligible providers can submit their
applications to convert to an REH to their Medicare Administrative
Contractor, at which point they will be screened for eligibility and to
ensure compliance with all Medicare enrollment requirements. CMS will
be posting the number hospitals that have successfully transitioned to
REHs on a publicly available CMS website.
Question. Thank you for implementing my Over-the-Counter Hearing
Aid Act with Senator Warren. This was a longstanding priority of mine.
The Biden administration has stated they plan to end the COVID-19
public health emergency (PHE) on May 11, 2023. While most telehealth
provisions under Medicare will remain in effect through the end of CY
2024, Iowa audiologists have communicated to me that telehealth CPT
codes they use will no longer be reimbursable under Medicare after May
11th. What is CMS planning to do to address potential access issues to
telehealth services after May 11th?
Answer. During the COVID-19 public health emergency (PHE) CMS
utilized its regulatory flexibilities to expand access to telehealth
services for Medicare beneficiaries. In order to maintain access to
audiology services during the PHE, CMS temporarily allowed for Medicare
coverage of certain audiology services when provided via telehealth. In
the CY 2021 PFS final rule, CMS created a third category of criteria
for adding services to the Medicare Telehealth Services List on a
temporary basis following the end of the PHE: Category 3. This new
category describes services that were added to the Medicare Telehealth
Services List during the PHE for which there is likely to be clinical
benefit when furnished via telehealth, but there is not yet sufficient
evidence available to consider the services for permanent addition
under the Category 1 or Category 2 criteria. Services added on a
temporary, Category 3 basis will ultimately need to meet the criteria
under Category 1 or 2 in order to be permanently added to the Medicare
Telehealth Services List.
As part of its CY 2023 Medicare Physician Fee Schedule final rule,
CMS finalized alignment of availability of services on the telehealth
list with the extension time frame enacted in the Consolidated
Appropriations Act, 2022 (CAA, 2022), which was for 151 days after the
end of the PHE. In addition, in response to comments, CMS finalized the
addition of several audiology CPT codes (CPT codes 92550, 92552, 92553,
92555, 92556, 92557, 92563, 92565, 92567, 92568, 92570, 92587, 92588,
92601, 92625, 92626, and 92627) to the Medicare Telehealth Services
List on a Category 3 basis. The services CMS temporarily included on
the Medicare Telehealth Services List on a Category 3 basis will
continue to be included through the end of CY 2023.
The Consolidated Appropriations Act, 2023 further extended the
telehealth flexibilities enacted in the CAA, 2022 through December 31,
2024. Given the recent legislative changes, CMS has updated and
simplified the Medicare Telehealth Services List to clarify that the
services will be available through the end of CY 2023, which is
available at https://www.cms.gov/medicare/medicare-general-information/
telehealth/telehealth-codes. CMS anticipates addressing updates to the
Medicare Telehealth Services List for CY 2024 and beyond through our
established processes as part of the CY 2024 Physician Fee Schedule
rulemaking process. CMS will continue to assess the benefits of the use
of telehealth for various services and is happy to provide technical
assistance on any legislation you draft on this issue.
______
Questions Submitted by Hon. John Cornyn
biosimilars
Question. How is CMS working to ensure that there is adequate
biosimilar uptake in Part D? As a lower cost alternative to pricier
biologics, it is imperative that the agency put in place policies to
ensure that seniors will have the options for biosimilars as part of
their Medicare Part D benefit. With the expected number of new
biosimilars expected to come out later this year, decisions about how
the agency will create access is crucial.
Is CMS working to ensure that seniors will have access to
biosimilars on their Part D plan formularies, including those that are
approved midyear?
Answer. HHS is committed to encouraging the use of biosimilar
biological products within the Secretary's scope of authority in order
to reduce costs to both beneficiaries and the Federal Government. In
general, however, a provision in the Part D statute prohibits the
Secretary of Health and Human Services from interfering with the
private negotiations between drug manufacturers and pharmacies and plan
sponsors, requiring a particular formulary, or instituting a price
structure for the reimbursement of covered Part D drugs. However, CMS
has the authority to review Part D plan formularies to ensure that drug
plans provide access to medically necessary treatments and do not
discriminate against any particular types of beneficiaries. CMS uses
this authority to review plan formularies for appropriate inclusion of
all drug classes. HHS will continue using its authority where possible
to seek to promote competition, support increased utilization of
biosimilar and generic drugs, reduce the Federal Government's spending
on drugs, and achieve greater equity in drug access and affordability
for beneficiaries.
medicaid cms bulletin
Question. CMS recently issued a bulletin on February 17th, ``Health
Care-Related Taxes and Hold Harmless Arrangements Involving the
Redistribution of Medicaid Payments.'' The bulletin seemed to indicate
that it views these arrangements as not permissible.
Does this bulletin represent a change that CMS is looking to
implement?
What steps is CMS looking to implement next? Is the agency
considering rulemaking?
How as the agency consulted States, and State Medicaid directors as
part of this effort?
Has CMS worked with stakeholders, such as safety net providers and
children's hospitals?
Answer. In February 2023, CMS issued an informational bulletin
reiterating Federal requirements concerning health care-related taxes
and hold harmless arrangements involving the redistribution of Medicaid
payments. This guidance, which does not establish new policy, was
issued as a reminder in response to questions received from several
States about complying with this provision of law. CMS recognizes that
health care-related taxes often finance critical programs that pay for
care provided to Medicaid beneficiaries and shore up the health care
safety net, and it will continue to approve permissible health care-
related taxes that meet Federal requirements and remains committed to
working with States.
epsdt benefit
Question. Medicaid's Early and Periodic Screening, Diagnostic and
Treatment (EPSDT) benefit is intended to guarantee that children have
access to all medically necessary, age-appropriate services, including
mental health services. Through the EPSDT benefit, children enrolled in
Medicaid should have access to a range of mental health services across
the continuum of care. Yet, while it sets an important standard,
significant gaps in access persist for some mental health services,
particularly for intermediate levels of care such as day programs and
intensive outpatient treatment.
As part of the Bipartisan Safer Communities Act, there was language
to have HHS review EPSDT implementation and provide updated guidance to
States. Can you give us an update on where your review stands and how
you are identifying gaps to ensure equitable access to critical mental
health services for children?
Answer. The Early and Periodic Screening, Diagnostic, and Treatment
(EPSDT) benefit provides comprehensive and preventive health-care
services for most children under age 21 who are enrolled in Medicaid.
EPSDT is key to ensuring that children and adolescents receive
appropriate preventive, dental, mental health, developmental, and
specialty services. States are required to provide comprehensive
services and furnish all Medicaid coverable, medically necessary
services needed to correct and ameliorate health conditions, based on
certain Federal guidelines. The Bipartisan Safer Communities Act
directs HHS to review State implementation of EPSDT requirements;
identify gaps and deficiencies with respect to State compliance with
EPSDT requirements; provide technical assistance to States to address
such gaps and deficiencies; and issue guidance to States on the
Medicaid coverage requirements for such services, including best
practices for ensuring children have access to comprehensive health-
care services, including children without a mental health or substance
use disorder diagnosis. The statute requires HHS to conduct this review
by June 2024.
______
Questions Submitted by Hon. John Thune
indian health service provider credentialing
Question. In January, Cesar Bartell, who worked as an optometrist
at an Indian Health Service facility in Sisseton, SD was found to have
a history of criminal charges for child molestation. As you know, this
is not the first time a provider employed by IHS has been found to have
a history of sexual abuse. I have raised concerns about a lack of
oversight and transparency at the IHS for many years. My legislation
with Senator Barrasso, the Restoring Accountability in the Indian
Health Service Act, would modernize the IHS credentialing system and
increase transparency. I understand IHS previously implemented a
credentialing and privileging system for new applicants and re-
applicants at IHS, but clearly there are still issues with identifying
issues with existing providers.
What is HHS doing to ensure the IHS has complete information
regarding a provider's history? Are there barriers if an investigation
occurs outside the State or locality in which the provider is currently
practicing?
Answer. The Indian Health Service (IHS) Director, as one of her
first actions as IHS Director, was to require all IHS-operated
hospitals and health clinics to clearly post information on the Hotline
for Reporting Child or Sexual Abuse, and to continue to conduct a
review of all provider credentialing information. For example, IHS
holds annual mandatory training, along with mandatory reporting on all
incidents of inappropriate sexual conduct. Additionally, a
credentialing review of providers is completed in regard to any red
flags of inappropriate behavior or conduct, and intermittent audits and
reports will be completed.
We take prevention of patient abuse extremely seriously and are
doing all we can to rebuild that trust. We have a strong patient safety
program that is rolling out across the agency, have established
mandatory reporting for all IHS staff with emphasis from agency
leadership, and have tightened scrutiny of all credentialing of medical
providers. The funding requested for the Office of Quality will support
critical activities to improve the quality of patient care and support
patient safety. The IHS requests $1.2 million for training, technical
assistance, and support at the facility level on patient safety issues.
Second, the IHS requests about $500,000 to identify patient safety and
administrative risks before incidents occur, and to mitigate those
risks across the agency.
IHS is currently using the MD-Staff application \75\ for
credentialing of all licensed providers (LPs) working in Federal
facilities. MD staff complete automated primary source verification of
multiple elements, including all (active and inactive) State licenses,
DEA registration, OIG sanctions, and National Practitioner Data Bank
(NPDB) queries. Furthermore, credential verification is automatic and
occurs continuously once a provider is hired. For example, should a new
adverse report be submitted to the NPDB on an IHS provider, the system
would notify the medical staff professional within 24 hours, prompting
review. Finally, LPs are privileged at hire, after their first year
(provisional privileges), and every 2 years thereafter, which requires
a complete review of their credentials.
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\75\ The MD-Staff application is a Commercial Off the Shelf (COTS)
software solution to automate and standardize the data collection,
storage, access, and approval (decision-making) credentialing process
for Indian Health Service. Credentialing consists of the validation of
licenser, training, education, proficiency, and currency of
professional health-care skills. The purpose also includes verifying
and auditing reporting systems on compliance with State, Federal, and
other applicable regulations.
An implicit barrier in this process are the existing database
limitations, wherein reporting bodies or States may or may not report/
participate and may, thus, preclude IHS from obtaining complete
information regarding a provider's history. Accordingly, IHS is limited
by what information is reported or provided to IHS by third parties
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such as State license boards or the NPDB.
Question. Will you commit to working with me and my staff on the
Restoring Accountability in the Indian Health Service Act, in order to
solve this persistent problem?
Answer. The Department, as well as the Indian Health Service, is
committed to working with you and your staff on this legislation.
telehealth
Question. Congress extended many of the flexibilities for Medicare
telehealth services that were enacted during the pandemic through the
end of 2024. We have learned a lot about telehealth during the
pandemic, and we should use these lessons and data to inform long-term
policy solutions to benefit patients and providers. That is why I'm
concerned that your budget does not include any long-term legislative
telehealth proposals in Medicare.
I originally authored legislation with my colleagues, the CONNECT
Act, prior to the pandemic, in an effort to support permanent access to
telehealth services. I am working to use the insights we've gained from
the pandemic to ensure the CONNECT Act now reflects the best long-term
policies for patients and providers in the future.
Are there specific telehealth policies that your administration
wants to work with Congress on to ensure progress isn't lost when the
flexibilities expire at the end of 2024? Will you commit to working
with me and my colleagues on the CONNECT Act to ensure patients have
permanent access to telehealth?
Answer. In response to the COVID-19 public health emergency, which
is set to expire in May 2023, flexibilities for Medicare telehealth
services were issued through legislative and regulatory authorities to
increase access to care for patients and providers. The Consolidated
Appropriations Act of 2023 recently extended many of these
flexibilities through December 31, 2024. Extended telehealth
flexibilities include waiving geographic and site of service
originating site restrictions so that Medicare patients can continue to
use telehealth services from their home and allowing audio-only
telehealth services. Additionally, the expanded list of providers
eligible to deliver telehealth services is also extended so Medicare
beneficiaries can continue to receive telehealth services furnished by
physical therapists, occupational therapists, speech language
pathologists, and audiologists, as well as receive telehealth services
from Rural Health Clinics and Federally Qualified Health Centers
through December 31, 2024. If you are interested in drafting
legislation to make these waivers permanent, CMS would be happy to
provide technical assistance.
Additionally, recent legislative and regulatory changes made
several telehealth flexibilities permanent. Federally Qualified Health
Centers and Rural Health Clinics can furnish certain behavioral and
mental health services via telecommunications technology. Medicare
patients can continue to receive these telehealth services in their
home as geographic restrictions on the originating site are eliminated
for these telehealth services. Certain behavioral and mental telehealth
services can be delivered using audio-only communication platforms, and
rural emergency hospitals can serve as an originating site for
telehealth services.
CMS would be happy to provide technical assistance on legislation
to make these waivers permanent or any other legislation you have to
expand access to telehealth.
With respect to HRSA, certain telehealth flexibilities have shown
to be beneficial to health-care providers and underserved patients,
such as relieving patients of originating site requirements and
allowing Federally Qualified Health Centers/Rural Health Clinics to
serve as distant site providers so patients can access telehealth
services at home. Access to quality audio-only telehealth services has
been of assistance to individuals from underserved communities with
limited data plans or other constraints that makes video more
challenging or costly.
modernizing the exchange of electronic health information
Question. In the 21st Century Cures final rule, ONC stated that it
intended the rule to be consistent with the privacy right for patients
already contained in HIPAA. However, I've heard from providers that
there continue to be cases where providers are not able to share EHR
data within their own system as is allowed under HIPAA. If the rule
works as intended, access to electronic health information should occur
while protecting privacy and supporting efficient health-care
operations for providers and patients. The FY 2024 budget states that
the Office of the National Coordinator for Health Information
Technology (ONC) will continue to carry out the 21st Century Cures
Final Rule by providing oversight on information blocking practices.
Are you concerned that electronic health record (EHR) vendors may
still be limiting the exchange of data, even in scenarios where
information sharing is permitted under HIPAA?
How will you ensure there is appropriate oversight of ONC to ensure
data is being shared as intended in the final rule?
Answer. Preventing inappropriate interference with access,
exchange, or use of patients' electronic health information that is
permitted by the HIPAA Privacy and Security Rules and consistent with
the patient's privacy preferences is an HHS priority. When the
information is needed to support safe, coordinated care, any limits EHR
vendors may be imposing for anti-competitive purposes would be a
serious concern that HHS will address where it is identified. Survey
data and information blocking claims received by HHS suggest hospitals
and potentially other health-care providers are not yet reporting
possible information blocking as often as they might be experiencing
it. HHS continues to promote to health-care providers the opportunity
to report information blocking they experience as well as avoiding
engaging in it themselves.
The HHS Office of the Inspector General (OIG), in close ongoing
coordination with other parts of HHS, including ONC and the Office for
Civil Rights (OCR), has the lead on information blocking enforcement.
The 21st Century Cures Act gave the HHS Inspector General authority to
investigate any claim that a health IT developer, health-care provider,
health information network, or health information exchange engaged in
information blocking.\76\ In the coming weeks, HHS expects to publish
our Office of the Inspector General (OIG) final rule establishing
procedures necessary to use the 21st Century Cures Act authority to
investigate information blocking claims and take enforcement action
against certain entities. Statutory authority to determine civil money
penalties specific to information blocking by health IT developers
(such as EHR vendors), health information exchanges, and health
information networks references violations identified through an OIG
investigation.\77\ OIG and ONC actively coordinate and will continue to
do so to ensure that, in addition to any civil money penalty action
taken by HHS through OIG, ONC also takes appropriate action under the
ONC Health IT Certification Program with respect to any Program-
participating EHR vendors (or other Program-participating developers)
determined by OIG to have committed information blocking.
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\76\ 42 U.S.C. 300jj-52(b) as added by section 4004 of the 21st
Century Cures Act (Pub. L. 114-255).
\77\ 42 U.S.C. 300jj-52(b)(2)(A), as added by section 4004 of the
21st Century Cures Act (Pub. L. 114-255).
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modernization of the ihs electronic health record
Question. Thank you for including more specific information in the
budget on the plans to update the Indian Health Service's electronic
health record system. As you know, I've continued to ask about the
progress and schedule just about every year, as I don't want to lose
sight of this important issue. The administration is proposing to make
all funding in IHS mandatory starting in 2025, which is a major change
in how IHS is funded. That said, the information included in the budget
seems to be in the context of a major change in how IHS is funded.
How will the Department continue the efforts on IT modernization if
the larger IHS proposal is not adopted?
Answer. The Indian Health Service (IHS) will continue to move
forward with modernization. The IHS released the Request for Proposals
for the enterprise electronic health record (EHR) system on August 4,
2022, and anticipates selecting a product in Fall 2023. The Health IT
Modernization project is significantly ramping up, and the IHS needs
major funding increases to build the system, remediate sites, and
deploy the new system. The President's budget fully funds the current
$6.2-billion EHR modernization estimate starting in FY 2024, and
continues with additional resources in the out years.
The IHS is currently in the one-time capital investment phase of
the modernization project. Once costs for ongoing operations and
maintenance are understood, the IHS will begin discussing how those
recurring costs should be allocated among sites. The current estimate
for the modernization project includes the funding necessary to support
all Federal, Tribal, and urban sites. The IHS continues to provide a
quarterly Tribal Consultation and Urban Confer on the health IT
modernization project and has provided a consultation letter to the
chair and ranking member of the House and Senate Appropriations
Committees in accordance with the bill language included in the IHS
appropriation.
If the IHS budget proposal is not adopted, it could substantially
slow progress to provide effective digital capabilities, force the IHS
to continue development in the Resource and Patient Management System
(RPMS), and risk creating confusion and fragmentation among Federal,
Tribal, and urban partners. RPMS is unsustainable, as demonstrated by
both internal (OIG) and external (GAO) assessments. If the IHS is
unable to proceed with meaningful modernization, the agency risks
catastrophic failures in health-care delivery, quality outcomes, and
third party revenue collections that are critical to the IHS and its
tribal and urban partners in achieving our collective mission.
durable medical equipment
Question. As you know, there are no competitively bid areas in
South Dakota for the Competitive Bidding Program for Durable Medical
Equipment (DMEPOS) in Medicare. However, CMS uses the bidding rates as
the basis for payment amounts in the non-bidding areas. In the past,
Congress and CMS have addressed low payment rates for Medicare DMEPOS
items in non-Competitively Bid Areas (CBAs) by using a blended rate. In
the 2020 CARES Act, Congress provided a 50/50 blended rate for rural
areas and a 75/25 blended rate for non-rural, non-CBAs. CMS has made
the 50/50 blended rates permanent, while 75/25 rates (extended by
Congress in the Consolidated Appropriations Act, 2023) are slated to
end at the end of this year.
Does the administration plan to take any administrative action to
address the rate for non-rural, non CBAs?
What are the administration's plans for the next round of the
Medicare Durable Medical Equipment Competitive Bidding Program?
Answer. As you note, the CARES Act increased the payment rates to a
75/25 blend for durable medical equipment (DME) and enteral nutrients,
supplies, and equipment furnished in areas other than rural and non-
contiguous non-CBAs through the duration of the COVID-19 Public Health
Emergency (PHE) period. In the May 2020 COVID-19 Interim Final Rule
with Comment Period (IFC), CMS stated its belief that the purpose of
this provision of the CARES Act was to aid suppliers in furnishing
items under very challenging situations during the PHE. Furthermore,
CMS has long maintained that the fully adjusted rates in nonrural non-
CBAs are sufficient. CMS will continue to monitor payments in all non-
CBAs, as well as health outcomes, assignment rates, and other
information.
______
Questions Submitted by Hon. Tim Scott
Question. South Carolina's seniors and disabled rely on Medicare
Advantage to provide them with high-quality and affordable care and
especially value the additional benefits and lower co-pays which
reduces their out-of-pocket costs.
Have you conducted an analysis on how this proposal would directly
impact providers and beneficiaries in each State and territory--
including rural versus urban areas?
Have you conducted an analysis on how this proposal will directly
impact medically vulnerable patient populations like dual-eligibles,
those with chronic conditions (including diabetes), and depression?
Have you conducted an analysis on how this proposal will directly
impact diverse beneficiaries?
Have you analyzed how this proposal will impact the national
health-care workforce and physician shortage in each State and
territory--including rural versus urban areas?
If so, can you share these analyses with the committee?
Answer. The proposed 2024 Advance Notice published on February 1,
2023 includes a series of routine technical updates, improvements, and
recalibrations that would result in an increase to MA payments for
plans in 2024. MA payments are expected to increase by 1.03 percent
from 2023 to 2024, as proposed. This is about a $4-billion increase in
MA payments for next year. The proposals in the Advance Notice improve
payment accuracy to ensure MA plan payments better reflect the expected
costs of care, with higher payments going to plans serving people with
greater health-care needs. This helps ensure that people in MA can
continue to access the care they need.
Additionally, there are protective features built into the MA risk
adjustment system to ensure that plans caring for dually eligible
individuals are paid adequately, and nothing in this proposal changes
those features. We will continue to pay much more for someone who is
dually eligible than someone who is not, even when they have the same
diagnoses. These higher payments decrease incentives for plans to favor
healthier enrollees or discriminate against sicker patients.
To the extent beneficiaries who are low-income or who are living in
rural or underserved areas have greater health-care needs, the proposed
model would better compensate plans for that care. Furthermore, Federal
law protects most dually eligible individuals from any cost sharing for
Medicare services, so specific plans changes in cost sharing cannot be
passed onto those dually eligible beneficiaries.
Under the proposed model updates, Medicare, and thus MA plans, will
continue to pay for the services beneficiaries need to treat chronic
conditions such as diabetes. As part of updating the risk adjustment
model, certain diabetes codes were removed because they are not
reliable predictors of cost. Over 300 diabetes codes remain in the risk
adjustment model. The proposed model would provide extra payments for
patients with diabetes who have complications associated with diabetes,
like chronic kidney disease, heart disease, and diabetic retinopathy.
In addition, there are other payment factors, such as a condition count
bump, that increases payment when beneficiaries have more
comorbidities. Thus, the 2024 Advance Notice proposals for this aspect
of the MA risk model would provide a more targeted and accurate payment
increase for a diabetic patient because it adjusts MA payments
according to the patient's full health profile, rather than using only
a diabetes diagnosis as a proxy for increased health-care costs. This
approach would help ensure that higher payments are directed to
diabetic patients with the greatest health-care costs.
Medicare, and thus MA plans, would also continue to pay for the
services beneficiaries need to treat depression. The proposed model
does not impact coverage of Medicare services or requirements for MA
plans to deliver covered services. Under the 2024 Advance Notice, MA
payments would more accurately reflect the costs of care associated
with this condition. While some depression codes were removed from the
model because they did not predict cost well or were duplicative or
were related to diagnoses in remissions, more than 350 depression codes
remain in the risk adjustment model.
Question. My colleague on this committee, Senator Cortez Masto, and
I co-led a letter to Centers for Medicare and Medicaid Services (CMS)
Administrator Brooks-LaSure expressing bipartisan support for the
Medicare Advantage program and the high-quality, affordable care it
provides to over 27 million seniors and people with disabilities. In
the CHRONIC Care Act, Congress allowed Medicare Advantage plans to
cover telehealth more fully. Consistent with that approach, CMS has
allowed telehealth encounters to count toward risk adjustment programs
so that telehealth can be offered as a benefit without penalty.
Can you assure this committee that CMS will maintain this policy so
as not to jeopardize access to care via telehealth for seniors and
people with disabilities?
Answer. In January 2021 CMS issued an updated health plan
management system memo on the applicability of diagnoses from
telehealth services for the purposes of risk adjustment. Under the
memo, Medicare Advantage (MA) organizations and other organizations
that submit diagnoses for risk adjusted payment are able to submit
diagnoses for risk adjustment that are from telehealth visits when
those visits meet all criteria for risk adjustment eligibility, which
include being from an allowable inpatient, outpatient, or professional
service, and from a face-to-face encounter. Diagnoses resulting from
telehealth services continue to meet the risk adjustment face-to-face
requirement when the services are provided using interactive audio
telecommunication simultaneously with video telecommunication to permit
real-time interactive communication with the beneficiary. This policy
remains in effect.
Question. The Centers for Medicare and Medicaid Services (CMS)
stated in January 2023: ``CMS will seek feedback and insights from a
broad range of interested parties throughout implementation of the IRA,
including implementation of the Negotiation Program. CMS is committed
to collaborating with and engaging the public in the policymaking
process. CMS will work closely with patients and consumers, Part D plan
sponsors and Medicare Advantage organizations, drug manufacturers,
hospitals and health-care providers, wholesalers, pharmacies, and
others.''
However, in the Part D Negotiation guidance released March 16,
2023, the agency said it will NOT take comments on proposals for
selecting the specific drugs to be negotiated, including particulars
around the basis for selecting the drugs and the extent to which drug
manufacturers may appeal CMS's decisions. These seem like pretty
important factors that could significantly affect a company's
operations and the patients they serve.
Given the IRA legislation has NOT afforded affected stakeholders no
judicial or administrative review in many areas, why would the agency
suppress the voice of impacted stakeholders, when they specifically
pledged they would seek feedback?
Answer. CMS recognizes that public input will help to achieve
successful implementation and broadly welcomes input from the public at
all times. In the initial guidance for the Medicare Drug Price
Negotiation Program, CMS decided on key topics to seek comment where
CMS would like specific input from the public to operationalize the new
program. Due to timing constraints and the requirement to publish the
selected drug list for initial price applicability year 2026 by
September 1, 2023, CMS is issuing guidance on topics related to drug
selection as final, without a comment solicitation.
CMS has sought and will continue to seek feedback and insights from
a broad range of interested parties throughout the implementation of
the Inflation Reduction Act, including but not limited to comment on
initial guidance. CMS is committed to collaborating and engaging with
the public in the policymaking process. CMS is working closely with
patients and consumers, Part D plan sponsors and Medicare Advantage
organizations, drug manufacturers, hospitals and health-care providers,
wholesalers, pharmacies, and others. CMS is engaging and will continue
to engage interested parties through national stakeholder calls,
quarterly strategic meetings, and monthly technical calls with CMS
staff. In addition, members of the public are welcome to share feedback
and input in writing by email at: [email protected].
Question. Since the bipartisan Orphan Drug Act was enacted 40 years
ago, rare disease and cancer patients have benefited from the
development of over 600 new treatments. This is a tremendous
achievement, though there's more work to be done. Too many patients
living with rare diseases and cancers still have no treatments
available to them. Unfortunately, the Inflation Reduction Act threatens
the continued success of the Orphan Drug Act. Specifically, it does not
protect therapies that treat two or more orphan diseases from
government price setting. As a result, we already know of two companies
that have cited the IRA as a reason not to continue rare disease drug
development.
Will you commit to doing what you can via guidance and rulemaking
to ensure that the pipeline of life-altering therapies continues for
patients living with rare diseases (like Sickle Cell, Parkinson's, ALS,
et cetera) and cancers?
Answer. FDA remains strongly committed to doing what we can via
guidance for industry and stakeholder engagement activities to maintain
and promote the robustness of the development pipeline for safe and
effective drugs and biological products to treat patients with rare
diseases, including rare cancers. FDA has published more than 18
guidance documents since 2018 on topics that are highly relevant to
drug and biological product development for rare diseases, including
rare cancers. Some recent examples include:
2023 Draft Guidance for Industry: Clinical Trial
Considerations to Support Accelerated Approval of Oncology
Therapeutics.\78\
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\78\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/clinical-trial-considerations-support-accelerated-
approval-oncology-therapeutics. This draft guidance, when finalized,
will represent FDA's current thinking on this topic.
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2023 Draft Guidance for Industry: Considerations for the
Design and Conduct of Externally Controlled Trials for Drug and
Biological Products.
2022 Guidance for Industry: Human Gene Therapy for
Neurodegenerative Diseases.
2022 Draft Guidance for Industry: Tissue Agnostic Drug
Development in Oncology.
Of note, with regard to promoting the development of treatments for
more than one rare disease at a time, both FDA and NIH, along with
several other entities, are working collaboratively to expedite
development of gene therapies for rare diseases that are caused by a
single genetic mutation and for which there is no commercial interest
in developing therapies due to each disease's rarity. This effort, the
Bespoke Gene Therapy Consortium, focuses on developing common gene
therapy platforms and standards that can be used in the manufacture of
several different gene therapies, each for a different rare disease,
and thus would increase efficiency overall.
Further, NIH and NCATS remain committed to supporting research to
find treatments and cures for rare diseases and conditions without a
treatment, and to increase the speed of therapeutic and diagnostic
development. At NIH, NCATS's Division of Rare Diseases Research
Innovation provides leadership, coordination and collaboration on rare
disease research programs across the NIH. Research on specific rare
diseases is supported by many NIH Institutes, Centers, and Offices
(ICOs) as falls within their respective missions.
NCATS supports rare disease research projects with applicability to
many diseases at a time, and works with other HHS operating divisions
to ensure appropriate resources and expertise are being applied. One
such program involving cross agency collaboration and targeting rare
diseases is the Bespoke Gene Therapy Consortium (BGTC), a partnership
with the Food and Drug Administration (FDA) and the Foundation for the
National Institutes of Health (FNIH), NCATS and 10 other NIH Institutes
and Centers (ICs), and several pharmaceutical companies and nonprofit
organizations, that will streamline gene therapy development and
products for rare disorders of no commercial interest. For BGTC
clinical trials, scientists will develop strategies for streamlining
the regulatory processes for FDA approval of safe and effective gene
therapies, and they will develop standardized approaches to preclinical
testing. BGTC has narrowed the potential diseases to be studied to 14,
and proposals for clinical trials are being reviewed, with the 5-6
chosen trials to be announced in May 2023.
Another collaborative research initiative is the NIH Common Fund's
Somatic Cell Genome Editing (SCGE) program, led by NCATS and the
National Institutes of Neurological Disorders and Stroke (NINDS). Phase
1 of the program aims to develop high-quality tools for performing safe
and effective genome editing in humans and then make these tools widely
available to the research community to reduce the time and cost of
developing new therapies. Based on the success of Phase 1, the Common
Fund approved a second phase of the program, which will be focused more
on accelerating somatic genome editing clinical trials. Applications
have been reviewed, and funded projects will be announced shortly. FDA
collaborated with the SCGE program throughout Phase 1, and given the
greater focus on clinical trials in Phase 2, the NIH and FDA plan to
establish a memorandum of understanding (MOU) to efficiently translate
the results from Phase 2 projects into the clinic.
Question. Diabetes is a major health crisis in our country, with
continuing significant increases particularly in the rate of type 2
diabetes, which can be prevented. In South Carolina, over 500,000
adults have been diagnosed with diabetes, another 120,000 people have
diabetes but are unaware, and 1.4 million have prediabetes. In total,
that's over half the population of my State. Evidence shows that
Diabetes Prevention Programs (DPP) delivered by all modalities of care
are effective, and the Centers for Disease Control and Prevention (CDC)
recognized DPPs served hundreds of thousands of privately insured
Americans in 2022 alone. In contrast, the Medicare Diabetes Prevention
Program (MDPP), which severely restricts the number of suppliers, has
served only 4,848 beneficiaries since 2018 according to a recent
Centers for Medicare and Medicaid Services evaluation report.
With the potential of MDPP now recognized in the administration's
budget, what is HHS doing to expand access to these important services
through the online and distance learning modalities that have already
been validated by the evidence base, by CDC and by the commercial
market?
Answer. CDC continues to implement, scale, sustain, and evaluate
the National Diabetes Prevention Program (National DPP) and projects
that support its implementation. The National DPP relies on results-
based partnerships with State health departments, private
organizations, insurers, and community-based organizations to deliver
and pay for the National DPP.
The National DPP has allowed virtual delivery since 2015. At the
start of the pandemic, CDC helped lifestyle change program providers
shift from in-person to virtual delivery. Since then, CDC has helped
providers maintain and expand their capabilities to deliver the program
virtually. For instance, CDC developed a Guide for Using Telehealth
Technologies (https://www.cdc.gov/diabetes/pdfs/programs/
E_Telehealth_translation_product_508.pdf) to provide users with
information to help inform their decisions regarding implementation of
different telehealth technologies and to provide specific
implementation considerations for each technology.
CDC remains focused on increasing access to the National DPP
lifestyle change program and funds national organizations to expand the
program in medically underserved areas and communities at high risk for
diabetes, including Medicare beneficiaries. For example, CDC has worked
with the National Association of Chronic Disease Directors and other
partners to implement a Medicare Diabetes Prevention Program (MDPP)
Enrollment Project. This project supports MDPP suppliers in promoting
the program to Medicare beneficiaries; increasing health-care provider
referrals to the program; and obtaining and using billing software to
process and submit claims to CMS, which supports program
sustainability.
CDC has also collaborated with National Association of Chronic
Disease Directors, Centers for Medicare and Medicaid Services, and the
American Medical Association to develop MDPP resources in its coverage
toolkit (Medicare Diabetes Prevention Program (MDPP) Implementation
Resources--National DPP Coverage Toolkit, https://coveragetoolkit.org/
medicare/mdpp-implementation-resources/). Examples of these resources
include a recorded webinar, frequently asked questions, and a fact
sheet for MDPP suppliers to navigate changes to their programs during
the public health emergency, such as flexibilities for virtual
sessions.
Additionally, as detailed by the White House National Strategy of
Hunger, Nutrition, and Health, the administration set a goal of ending
hunger and increasing healthy eating and physical activity by 2030 so
fewer Americans experience diet-
related diseases--while reducing related health disparities.
Integrating nutrition and health can optimize Americans' well-being and
reduce health-care costs. Currently, only a limited number of Medicare
beneficiaries are seeking nutrition and obesity counseling services.
The President's FY 2024 budget includes a proposal to expand access to
additional beneficiaries with nutrition or obesity-related chronic
diseases and make additional providers eligible to furnish services.
Medicare covers an array of services that aim to address obesity.
For example, obesity screenings, intensive behavioral therapy for
obesity for the prevention or early detection of illness or disability,
bariatric surgical procedures, and diabetes screenings and
participation in a diabetes prevention program are covered under
Medicare in certain cases. Under current law, the Medicare statute
excludes ``agents when used for anorexia, weight loss, or weight gain''
from the definition of a Part D drug in section 1860D-2(e) of the
Social Security Act. Despite this statutory exclusion, Part D sponsors
wishing to provide coverage of prescription weight loss agents may do
so as a supplemental benefit to enhanced alternative Part D plans, as
they can with other prescription drugs that are excluded from the
definition of a Part D drug.
Question. During the COVID-19 public health emergency (PHE) the
Centers for Medicare and Medicaid Services (CMS) provided flexibility
to allow the virtual supervision of drug infusions by nurse
practitioners through real-time audio/video technology. Providers have
been expediently utilizing this flexibility throughout the PHE, when
appropriate, which has increased access to care, maintained patient
safety, and enabled patients to follow their treatment plans more
easily without interruptions due to staffing shortages or canceled
appointments. This flexibility is especially important and can be
beneficial as the country continues to face widespread health-care
workforce shortages and access issues for rural patients. In the
Calendar Year 2023 Physician Fee Schedule (PFS), CMS declined to extend
this flexibility beyond the PHE, though they said they would consider
comments received from the proposed rule for potential future PFS
rulemaking.
Has CMS done any further evaluation of this vital flexibility, and
do you plan on extending or making it permanent?
Answer. During the public health emergency (PHE) for COVID-19, CMS
temporarily modified the regulatory definition of direct supervision,
which requires the supervising physician or practitioner to be
``immediately available'' to furnish assistance and direction during
the service, to include ``virtual presence'' of the supervising
clinician through the use of real-time audio and video technology.
Under our currently finalized policies, CMS will continue to permit
direct supervision through a virtual presence through the end of the
year in which the PHE ends (through December 31, 2023). We continue to
gather information on this topic, and we appreciate the information
provided by commenters in the CY 2023 Physician Fee Schedule Rule. We
believe allowing additional time to collect information and evidence
for direct supervision through virtual presence will help us to better
understand the potential circumstances in which this flexibility could
be appropriate permanently, outside of the PHE for COVID-19.
Question. Medicare physician payments, which were dramatically
altered following the passage of the Medicare Access and CHIP
Reauthorization Act (MACRA) in 2015, and its impact on patient access
to care remains a major issue for my constituents. In fact, adjusted
for inflation in practice costs, Medicare physician pay actually
declined 26 percent from 2001 to 2023, or by 1.8 percent per year on
average. Congress has been forced to provide annual payment patches to
prevent, in part, budget neutrality driven cuts to the Medicare
Physician Fee Schedule. It is clear that the Medicare physician payment
system is broken.
What is HHS doing administratively to make the Medicare payment
system run more smoothly? Does HHS to have the necessary authority to
make improvements to the MACRA program?
Answer. Ensuring adequate payment rates for physicians and other
health-care professionals is essential in maintaining access to high-
quality and affordable health care. HHS appreciates Congress'
leadership in the Consolidated Appropriations Act of 2023 to provide
temporary, 1-year increases in payment amounts for all services under
the physician fee schedule by 2.5 percent in 2023 and 1.25 percent in
2024. HHS also appreciates Congress's work to extend incentive payments
for clinicians who are qualifying participants in advanced alternative
payment models through 2025. CMS does not have the legal authority to
implement increases in payment outside of budget neutrality without
additional action taken by Congress. Annual Medicare physician payment
updates have been set in statute since 2015. CMS does not have the
authority to use a different update. If Congress wants to change the
law, we would be happy to provide technical assistance on legislation
you draft.
Question. The fall 2022 Department of Health and Humans Services
Unified Agenda regulatory calendar currently lists April 2023 as the
target date for Centers for Medicare and Medicaid Services (CMS) to
release the Medicare Transitional Coverage for Emerging Technologies
(TCET) proposed rule (CMS-3421, https://www.reginfo.gov/public/do/
eAgendaViewRule?pubId=202210&RIN=0938-AU86), which would provide
transitional Medicare coverage for new medical technologies.
Can you assure this committee that CMS will issue the TCET proposed
rule by April 2023, particularly given that this rule was initially
scheduled for release in 2022, and originally discussed over 2 years
ago when the Medicare Coverage of Innovative Technology rule was
repealed? Assuming that CMS publishes the TCET proposed rule in April
2023, when does the agency expect to release and implement the final
rule?
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 has conducted 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.
Question. Unfortunately, South Carolina ranks towards the bottom of
U.S. States when it comes to maternal mortality rates. A March 2022
legislative brief from the South Carolina Maternal Mortality Review
Committee showed that in 2021, South Carolina completed the review of
pregnancy-related deaths occurring in 2018 which resulted in the first
report of the South Carolina Pregnancy-Related Mortality Ratio (PRMR)--
35.3 pregnancy-related deaths per 100,000 live births in 2018. This
number is well above the national average. This is clearly an issue
impacting my constituents.
The birthing-friendly hospital designation was implemented to show
the public what hospitals were meeting the guidelines set out, but what
are the administration's next steps beyond publishing that list?
Answer. Medicaid is the largest single payer of pregnancy-related
services and covers over 42 percent of births nationally. The
Children's Health Insurance Program (CHIP) also covers pregnant
adolescents and, in some States, low-income pregnant individuals with
income over the Medicaid income limit. Together, Medicaid and CHIP play
a critical role in ensuring access to care for pregnant and postpartum
individuals, improving the quality of maternal health care, and
addressing disparities in health outcomes and pregnant and postpartum
care. The American Rescue Plan Act of 2021 gave States a new option to
provide 12 months of continuous postpartum coverage to pregnant
individuals enrolled in Medicaid and CHIP beginning April 1, 2022, for
a period of 5 years.\79\ The Consolidated Appropriations Act, 2023,
made permanent this State option. To date, more than 30 States and the
District of Columbia have elected to extend postpartum coverage,
including South Carolina.\80\
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\79\ https://www.medicaid.gov/federal-policy-guidance/downloads/
sho21007.pdf.
\80\ https://www.medicaid.gov/federal-policy-guidance/downloads/
image-maternity-care-expansion.png.
Additionally, in July 2022, CMS released its Maternity Care Action
Plan (https://www.cms.gov/files/document/cms-maternity-care-action-
plan.pdf) to support the implementation of the Biden-Harris
administration's Blueprint for Addressing the Maternal Health Crisis
(https://www.whitehouse.gov/briefing-room/statements-releases/2022/06/
24/fact-sheet-president-bidens-maternal-health-blueprint-delivers-for-
women-mothers-and-families/
#::text=The%20Blueprint%20outlines%20five%20
priorities,outcomes%20in%20the%20United%20States%3A&text=Increasing%20ac
cess
%20to%20and%20coverage,services%2C%20including%20behavioral%20health%20
services). The action plan takes a holistic and coordinated approach
across CMS to improve health outcomes and reduce inequities for people
during pregnancy, childbirth, and the postpartum period. CMS's
implementation of the action plan will support the Biden-Harris
administration's broad vision and call to action to improve maternal
health.\81\ CMS is always happy to receive feedback from stakeholders
on additional ways the agency can advance equity and reduce disparities
in maternity care.
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\81\ https://www.cms.gov/newsroom/press-releases/cms-releases-
maternity-care-action-plan-implement-biden-harris-maternal-health-
blueprint-launches.
Question. Due to the complexity of the pharmacy practice, many
pharmacy students undertake a residency in a hospital. According to
Federal regulation, pharmacy residency programs operated by hospitals
that are affiliated with or owned by a health system or academic
medical center are required to be directly controlled by those
hospitals (42 CFR Sec. 413.85). These hospitals receive pass-through
payments from Medicare. However, due to a lack of clarity and Medicare
Administrative Contractors' (MACs) inconsistent interpretation of what
is needed to meet the ``direct control'' requirement, hospitals and
affiliated health systems need greater clarity from the Department of
Health and Humans Services and the Centers for Medicare and Medicaid
---------------------------------------------------------------------------
Services (CMS) to ensure compliance.
Can hospitals share or contract for administrative functions the
health systems, without violating 42 CFR Sec. 413.85(f)(1)(i)-(v)? What
documentation would assist CMS in confirming that the hospital retains
control of the residency program?
Answer. Under Medicare regulations, Pharmacy Residency Programs
must meet certain requirements in order to claim pass-through payments
from Medicare. These regulations (42 CFR Sec. 413.85) require providers
to meet a number of requirements with respect to training costs,
curriculum, instruction, and program administration. Specifically, with
respect to program administration, the regulations state that the
operator must ``control the administration of the program, including
collection of tuition (where applicable), control the maintenance of
payroll records of teaching staff or students, or both (where
applicable), and be responsible for day-to-day program operation. (A
provider may contract with another entity to perform some
administrative functions, but the provider must maintain control over
all aspects of the contracted functions.)''
Question. Many osteopathic medical students choose to actively
pursue careers in primary care, strengthening the backbone of our
Nation's health-care system. Fifty-seven percent of osteopaths practice
in primary care (including family medicine, internal medicine, and
pediatrics). Osteopathic medical education also has a proven history of
establishing educational programs for medical students and residents
that target the health-care needs of rural and underserved populations.
Sixty percent of colleges of osteopathic medicine are located in health
professional shortage areas, 64 percent require their students to go on
clinical rotations in rural and underserved areas, and 88 percent have
a stated public commitment to rural health. Further, 41 percent of
graduating 2020-2021 osteopathic medical students plan to practice in a
medically underserved or health shortage area; of those, 49 percent
plan to practice in a rural community.
What role will osteopaths and the osteopathic medical education
community serve in the HHS Initiative to Strengthen Primary Health
Care?
Answer. Thank you for your question regarding the HHS Initiative to
Strengthen Primary Health Care and the role of osteopathic physicians
and the osteopathic medical education community. The HHS Initiative to
Strengthen Primary Health Care was launched in September 2021 to
strengthen the Federal foundation for the provision of whole person
primary care for all, to improve: access to health care, the health and
well-being of people, families and communities, and health equity.
Primary care is the foundation and entry way of our health-care system
and strong primary care has been documented to improve health,
longevity, and health equity.
A first deliverable of the HHS Initiative to Strengthen Primary
Health Care is an HHS Action Plan to Strengthen Primary Care. This has
been collaboratively developed by 14 HHS Operating and Staff Divisions
and coordinated by the Office of the Assistant Secretary for Health.
The action plan, which outlines actions HHS will take in FY 2023 and
2024, under current funding and statutory authority, is in the final
stages of HHS clearance and will be released later this year. The HHS
Action Plan focuses on increasing investment in primary care and
advancing effective payment models, strengthening the workforce,
improving equitable access to primary care, advancing digital health to
support primary care, and advancing primary care research and its
translation into practice.
Primary care clinicians are physicians, nurse practitioners,
physician assistants, and clinical nurse specialists who practice
primary care. They often practice in a team that may include nurses,
medical assistants, case managers, community health workers, and other
staff members. With integration of other clinical services and primary
care, such as behavioral health, oral health and clinical pharmacy, the
team expands its multiple disciplines. For physicians, the major
specialties of primary care are family medicine, general internal
medicine, general pediatrics, and geriatrics.
Osteopathic physicians are important members of the primary care
physician workforce and, as you note, are particularly important for
the primary care workforce in medically underserved and rural areas. In
addition, the osteopathic medicine approach, which focuses on health
and well-being and holistic, person-centered care, is completely
aligned with the aims and vision of the HHS Action Plan to Strengthen
Primary Care. Osteopathic medical education is also very much
community-based, which the HHS Initiative aims to foster. Thus,
osteopathic physicians and osteopathic medical education are integral
to the HHS Initiative to Strengthen Primary Health Care and the HHS
Action Plan to Strengthen Primary Care.
In the process of developing the HHS primary care action plan, the
American Association of Colleges of Osteopathic Medicine (AACOM)
responded to the HHS Initiative to Strengthen Primary Health Care
Request for Information and the OASH Primary Health Care team held a
listening session with AACOM to discuss osteopathic medical and
graduate medical education.
______
Questions Submitted by Hon. James Lankford
unaccompanied children
Question. In Fiscal Year 2022, the Department of Homeland Security
referred 128,904 unaccompanied children to the Office of Refugee
Resettlement. That is more than triple the number of unaccompanied
children that arrived to the United States in fiscal year 2017. In
response to this dramatic increase in vulnerable children coming to the
border, The New York Times reports that the Department of Health and
Human Services has prioritized speed over safety when placing
unaccompanied children with sponsors.
Moreover, myself and six other Senators sent a letter to you last
year that has gone unanswered expressing our concern with ORR's
dependence on Field Guidance #21 which instructs staff to place
pregnant unaccompanied children in ORR facilities based on the State's
abortion laws in which the facility is located. A child's referral to
ORR is an opportunity to treat them with care while searching for
appropriate, vetted sponsors, not an opportunity to encourage the
taking of unborn life. Every life is worthy of protection, born or
unborn. In light of these concerns, please answer the following
questions.
How many abortions has HHS ORR facilitated for unaccompanied minors
in its custody? Please include a breakdown of chemical abortions and
surgical abortions and whether such abortion took place at an ORR
facility.
Answer. ORR has strict confidentiality policies related to sharing
health-care information of the children it serves, including regarding
their reproductive health. ORR policy requires, to the greatest extent
possible, placement of pregnant unaccompanied children requesting an
abortion in ORR programs that are State licensed to care for pregnant
children and in an appropriate location to support the child's health-
care needs. This includes access to an appropriate medical provider who
is able to legally perform the requested abortion. The particulars of
the abortion procedure are the purview of medical providers, not ORR.
Question. How much Federal funding has HHS spent on facilitating
abortions for minors including, staff time, transportation and
accommodation costs? Please provide a breakdown of the costs by type.
Answer. ORR complies with Federal law, including Federal
appropriation restrictions regarding payment for abortions as passed by
Congress.
Question. Please provide a list of all States and localities where
HHS ORR has transported pregnant unaccompanied minors in order to
facilitate their access to abortion.
Answer. ORR does not capture this information in a reportable
format. As a matter of policy, travel to access comprehensive medical
services is permissible and routine for unaccompanied children in ORR
care and custody (see ORR Unaccompanied Children (UC) Program Policy
Guide Sections 3.4, 3.4.3 and 3.4.4, https://www.acf.hhs.gov/orr/
policy-guidance/unaccompanied-children-program-policy-guide-section-3).
Question. What steps is HHS taking to coordinate with law
enforcement to identify and remove children from unsafe sponsorships?
How many children has HHS removed from such unsafe sponsorships since
January 2021? Please share with the committee a breakdown of the number
and reasons for such termination?
Answer. ORR's custodial authority over unaccompanied children ends
when a child is released from ORR care. ORR does not have the authority
to remove a child from a household once released--that authority
resides with each State's child protective services.
ORR conducts a minimum of three safety and well-being calls to
children and sponsors after ORR releases a child from its care. ORR
cannot require children and sponsors to participate in safety and well-
being calls, and they may choose not to answer a call for a variety of
reasons. Also, upon their release, ORR provides children with
information on the ORR National Call Center (ORRNCC), a 24-hour, 7 days
a week, resource. Care providers, post-release services (PRS)
providers, and ORRNCC staff are required to document and report any
safety concern, in accordance with mandatory reporting laws, State
licensing requirements, Federal laws and regulations, and ORR policies
and procedures to ORR, as well as to the appropriate local law
enforcement agency, State and local child protective services, or both.
Over the last 2 months, ORR has implemented a requirement for the
ORRNCC to provide children who call the helpline and express safety
concerns with information regarding the authorities to which their
safety concerns will be reported. It also connects children directly
with the appropriate authority when possible and place an additional
follow-up call to the child to confirm if any further actions are
needed. If a placement is found to no longer be safe for a child, ORR
and its grant recipients and contractors alert the necessary law
enforcement entities and child protective services, which have the
legal authority to take appropriate action--an authority that does not
rest with the U.S. Department of Health and Human Services (HHS).
Question. What is the extent of Interagency Coordination with HHS
Office of Refugee Resettlement, DHS, and DOL on ensuring the welfare of
unaccompanied children at the border?
Answer. Under the Homeland Security Act of 2002 and the Trafficking
Victims Protection Reauthorization Act (TVPRA) of 2008, ORR is legally
required to provide for the care and custody of all unaccompanied
children from the moment they enter ORR's custody following a referral
from the U.S. Department of Homeland Security (DHS) or other Federal
entity until they are appropriately and safely released to a vetted
sponsor. For additional information about ORR's vetting policies, see
ORR UC Program Policy Guide section 2, https://www.acf.hhs.gov/orr/
policy-guidance/unaccompanied-children-program-policy-guide-section-2.
ORR and DHS coordinate the transfer of unaccompanied children from
DHS custody to ORR custody. At the time of referral, DHS shares all
pertinent information related to the unaccompanied child to facilitate
the child's placement into ORR's custody. This information includes
basic biographical data on the child; situational factors such as
health, pregnancy, travel companions; human trafficking indicators; and
any known criminal records or behavioral issues. DHS enters all
information via the Unaccompanied Children Portal--ORR's system of
records. ORR uses this information to make a placement designation
within 24 hours and notifies both the referring agency and the care
provider by email when a suitable placement becomes available, which by
statute must occur within 72 hours of DHS's determination of the
child's unaccompanied child status. DHS's Immigration and Customs
Enforcement (ICE) is responsible for the physical transfer of
unaccompanied children to ORR-funded care provider facilities. The ICE
transportation contractor coordinates directly with U.S. Customs and
Border Protection (CBP) and ORR for operational arrangements and
estimate time of arrival notices.
Coordination between HHS and the U.S. Department of Labor are
ongoing. On March 23, 2023, the Department of Labor's Wage and Hour
Division (DOL/WHD) and HHS's Administration for Children and Families
signed an agreement to formalize a partnership between the agencies and
outline procedures the agencies will follow as they work together to
deepen information-sharing, coordination, training, and education. The
Memorandum of Agreement (MOA) seeks to maximize DOL/WHD's enforcement
of the child labor protections within the Fair Labor Standards Act and
to enhance HHS/ACF's ability to protect children from exploitation and
to connect individuals to needed benefits and services. The MOA
includes unprecedented steps for greater collaboration between the two
agencies to prevent and address illegal child labor.
Question. On February 27th, HHS announced a 4-week audit of their
vetting process for sponsors for unaccompanied children. Will you
commit to providing the committee a copy of the written report
describing the outcome of your audit and provide an interagency
briefing for the committee following the HHS audit of sponsor vetting
processes?
Answer. ORR looks forward to providing more information on the
outcome of the audit soon, which will inform ongoing process
improvements to ORR's UC program. Further information regarding the
audit is anticipated soon.
health in america
Question. In your opening statement, you mentioned that HHS is
working on policies that would help our health system not be an
``illness care'' system, but a ``wellness care'' system instead.
What efforts has HHS taken to address health problems in America
through healthy eating and lifestyle changes instead of solely focusing
on increased funds to public health programs?
Answer. By far, the greatest burden of disease in the United States
is attributable to diseases related to poor nutrition and low rates of
physical activity. At the most foundational level, HHS leads the
development of evidence-based nutrition and physical activity
guidelines, which are the basis for numerous initiatives designed to
advance health and prevent disease in America. These foundational
documents have been iteratively produced for decades. A description of
the Dietary Guidelines for Americans and the Physical Activity
Guidelines for Americans can be found below, along with examples of
initiatives that HHS has created to implement these guidelines, to help
improve healthy eating and physical activity among diverse populations.
HHS also works with Federal partners to develop national objectives
related to healthy eating and physical activity through its
longstanding Healthy People (https://health.gov/healthypeople)
initiative, as congressionally mandated. By focusing action across
public health and related sectors of government and civil society
toward achieving these key Healthy People objectives, we can improve
health and well-being.
Through the COVID-19 pandemic, HHS has coordinated a whole of
government initiative--Equitable Long-Term Recovery and Resilience
(https://health.gov/our-work/national-health-initiatives/equitable-
long-term-recovery-and-resilience)--to develop and implement a Federal
plan that has the potential to orient most extant Federal resources to
favorable outcomes in individual and community resilience, as defined
in the framework of Vital Conditions for Well-being. This broader
initiative is designed to affect longitudinal change at a systems level
such that the conditions for healthy living and thriving are enhanced
equitably across communities.
Improving Healthy Eating Through Evidence-Based Guidance: Dietary
Guidelines for Americans
The U.S. Departments of Health and Human Services (HHS) and
Agriculture (USDA) work together to update and release the statutorily
mandated Dietary Guidelines for Americans (Dietary Guidelines, https://
www.dietaryguidelines.gov/) every 5 years. The Dietary Guidelines
provides advice on what to eat and drink to meet nutrient needs,
promote health, and prevent disease. Each edition of the Dietary
Guidelines reflects the current body of nutrition science and is
developed and written for a professional audience, including
policymakers, health-care providers, nutrition educators, and Federal
nutrition program operators.
On January 19, 2023, the HHS and USDA announced the appointment of
20 nationally recognized nutrition and public health experts to serve
on the 2025 Dietary Guidelines Advisory Committee. The Committee is
tasked with reviewing the current body of nutrition science on specific
topics and questions and developing a scientific report that includes
its independent, science-based advice for HHS and USDA to consider. The
Committee's review, along with public comments on its scientific report
and agency input, will help inform HHS and USDA as they develop the
Dietary Guidelines for Americans, 2025-2030.
Examples of HHS efforts to implement the Dietary Guidelines:
1. Toolkit for Health Professionals: Health professionals play
a key role in encouraging healthy food and beverage choices. To
assist health professionals in implementing the evidence-based
nutrition guidance found in the Dietary Guidelines for
Americans, 2020-2025, the HHS Office of Disease Prevention and
Health Promotion developed a suite of materials (https://
health.gov/our-work/nutrition-physical-activity/dietary-
guidelines/current-dietary-guidelines/toolkit-professionals) to
help health professionals start a conversation and share key
messages with patients, clients, and peers.
2. Updated definition of the ``healthy'' claim: On September
28, 2022, the Food and Drug Administration issued a proposed
rule to update the definition of the nutrient content claim
``healthy'' to align with the Dietary Guidelines for Americans,
2020-2025 and the updated Nutrition Facts label. The
``healthy'' claim can act as a quick signal on food package
labels to help empower consumers, including those with lower
nutrition knowledge, with information to identify foods that
will help them build healthy eating patterns.
Diet-related chronic diseases in the United States are the leading
causes of death and disability. Healthy eating patterns, which include
fruits, vegetables, lower-fat dairy, and whole grains, are associated
with improved health, such as reduced risk of cardiovascular disease,
type 2 diabetes, certain types of cancers, and being overweight or
obese. Providing informative and accessible food labeling empowers
consumers and may help foster a healthier food supply for all if some
manufacturers include more fruits, vegetables, dairy, and whole grains
and limit saturated fat, sodium, and added sugars in their products to
qualify to use the updated claim.
Improving Physical Activity Through Evidence-Based Guidance: Physical
Activity Guidelines for Americans
The Physical Activity Guidelines (https://health.gov/our-work/
nutrition-physical-activity/physical-activity-guidelines/current-
guidelines) is an essential resource for health professionals and
policymakers. It includes recommendations for Americans ages 3 years
and over--including people at increased risk of chronic disease--and
provides evidence-based advice on how physical activity can help
promote health and reduce the risk of chronic disease. The Guidelines
serves as the primary, authoritative voice of the Federal Government
for evidence-based guidance on physical activity, fitness, and health
for Americans.
HHS released the first edition of the Guidelines (https://
health.gov/our-work/physical-activity/previous-guidelines/2008-
physical-activity-guidelines) in 2008, followed in 2013 by the Physical
Activity Guidelines for Americans Midcourse Report: Strategies to
Increase Physical Activity Among Youth (https://health.gov/our-work/
physical-activity/previous-guidelines/2013-midcourse-report). The
current version--the second edition of the Physical Activity Guidelines
for Americans--was released in 2018. A midcourse report for this
iteration will be released in June 2023, focused on strategies to
increase physical activity among older adults.
Examples of HHS efforts to implement the physical activity
guidelines for Americans:
1. Move Your Way Campaign: The HHS Office of Disease
Prevention and Health Promotion developed the Move Your Way
(https://health.gov/our-work/nutrition-physical-activity/move-
your-way-community-resources) campaign to promote
recommendations from the second edition of the Physical
Activity Guidelines for Americans. Rather than a one-size-fits-
all approach, Move Your Way emphasizes personalized, practical
strategies that people can use to fit more activity into their
busy lives, while clearly communicating the amount and types of
physical activity Americans need to stay healthy. The campaign
includes a partner toolkit with materials in English and
Spanish to promote the benefits of physical activity among a
wide variety of audiences.
2. National Youth Sports Strategy (NYSS): According to the
Physical Activity Guidelines for Americans, youth ages 6 to 17
years need at least 60 minutes a day of moderate-to-vigorous
physical activity. Playing sports is one way youth can get the
physical activity they need. Sports also provide opportunities
for youth to experience the connection between effort and
success, and may enhance their academic, economic, social, and
health prospects.
In 2019, ODPHP launched the National Youth Sports Strategy (NYSS,
https://health.gov/our-work/nutrition-physical-activity/national-youth-
sports-strategy/about-national-youth-sports-strategy) with the goal of
uniting the U.S. youth sports culture around a shared vision: that one
day, all youth will have the opportunity, motivation, and access to
play sports. The Strategy is based on research and best practices from
the scientific community and successful youth sports programs across
the United States. It offers actionable ideas for parents, coaches,
organizations, communities, and policymakers to support youth sports
participation for all.
Following the release of the NYSS, the Office of Disease Prevention
and Health Promotion (ODPHP) created the NYSS Champions program as a
way to recognize organizations that promote youth sports in their
communities and help achieve the NYSS vision: that one day, all youth
will have the opportunity, motivation, and access to play sports.
3. Active People, Healthy NationSM: Active People,
Healthy Nation (https://www.cdc.gov/physicalactivity/
activepeoplehealthynation/about-active-people-healthy-
nation.html) is a national initiative led by CDC to help 27
million Americans become more physically active by 2027. To
achieve this goal, CDC has created tools for action (https://
www.cdc.gov/physicalactivity/activepeoplehealthynation/
everyone-can-be-involved/index.html) so that communities can
implement evidence-based strategies to increase opportunity for
greater physical activity across a variety of sectors and
settings.
The NIH Office of Nutrition Research (ONR) is leading a cross-
government initiative on Food is Medicine research, which would
integrate nutrition science and health care. Through this initiative,
supported by funding requested in the FY 2024 President's budget,
healthy eating and lifestyle changes to reduce the burden of diet-
related chronic diseases, including diabetes and obesity, which are
some of the most deadly and costly in this country, will be emphasized.
ONR has developed a comprehensive Food is Medicine Networks or Centers
of Excellence program that aims to support clinical nutrition research
on the effectiveness of increasing attention to healthy diets and
lifestyles within the medical enterprise. It aims to expand clinical
nutrition science and lifestyle medicine training in medical school
curricula and across health professions. Working in partnership with
other Federal agencies, these NIH Networks or Centers of Excellence
will aim to develop the evidence-base and identify the most effective
approaches to healthy eating and lifestyle medicine to both prevent and
treat diet-related chronic diseases.
``inflation reduction act'' impact on cancer
Question. The administration, including the President himself
during his State of the Union speech, has been touting the Cancer
Moonshot initiative and the goal to ``cut cancer death rates in half in
the next 25 years.'' Oklahoma has a state-of-the-art NCI-designated
cancer research and treatment facility.
However, I am wondering how the administration is taking into
account its own actions in actually keeping itself from reaching its
own goals? As I am sure you have seen, several drug manufacturers have
noted that they will likely be forced to remove drugs, nearly all of
them mentioning cancer drugs specifically, from production because of
the impacts of the IRA drug price setting policies. So at the same
time, the administration is claiming they are going to cure cancer, the
companies that actually do the R&D on possible cancer cures, are saying
that they are having to pull back because of a policy that same
administration supported.
How many more tax-payer dollars will have to be spent to make up
for the cancer treatments that the private industry was already working
on?
Answer. FDA is not involved in drug pricing, nor does it control
the business decisions made by pharmaceutical companies. We will
continue to work with the pharmaceutical industry to expedite the
development of cancer products through our expedited programs and
Oncology Center of Excellence regulatory review pilots.
Question. How much faster could cancer treatments that were already
in the pipeline get to patients if their manufacturers were
incentivized to produce them instead of if they are disincentivized as
they are now?
Answer. FDA is committed to working with all drug stakeholders
including the pharmaceutical industry to modernize evidence generation
throughout all phases of development and use FDA expedited programs to
speed access and approval of products to diagnose and treat patients
with cancer.
alzheimer's
Question. One in three seniors die from Alzheimer's or a related
form of dementia. Bipartisan groups of members in Congress have written
to the administration about concerns over the CMS National Coverage
Determination (NCD) policy and its impact on access to Alzheimer's
therapeutics and diagnostics. This new class of Alzheimer's treatments
gives families hope that they will have more quality time with their
loved ones before the disease takes hold. Since then, CMS has declined
to open the NCD to increase access for patients and families in need.
Why is your agency treating patients with Alzheimer's differently
than others with life-threatening conditions?
What gives CMS more authority than the FDA to decide if a drug is
safe and effective?
Answer. Alzheimer's disease is a devastating illness that affects
millions of Americans and their families. CMS is committed to helping
people get timely access to treatments and improving care for people
with Alzheimer's disease and their families. CMS has a responsibility
to ensure that people with Medicare have appropriate access to
therapies that are reasonable and necessary for use in the Medicare
population.
The FDA performs a vital and an important role. CMS recognizes the
important and related--but different--roles of the respective agencies.
The FDA determines whether to approve a new medical product based on a
careful evaluation of the available data and a determination that the
medical product is safe and effective for its intended use. CMS
conducts its own independent review to determine whether an item or
service is reasonable and necessary for use in the Medicare population
and should be covered nationally by Medicare.
nursing homes
Question. Recently, CMS has suggested placing some additional
requirements on nursing homes with the stated goal of increasing
patient safety, including the implementation of Federal staffing ratio
requirements. Most States have their own staff ratios to account for
their individual populations and what needs and workforce looks like in
their State. While we have the same goal of helping nursing homes keep
patients safe, Federal standardized staff requirements will not help
quality of care. In fact, it may actually decrease it by causing some
facilities to close their doors. SNFs in rural Oklahoma are already
caring for a large variety of patients, both with long term and short
term needs--sometimes because they are one of the only Medicaid
providers in the area. By placing Federal requirements on a system that
is not one-size-fits-all, you are actually hurting the most vulnerable
patients in the system.
What type of real stakeholder engagement has CMS engaged in to
create proposals like the Federal staffing requirement, besides opening
a comment period in the Federal Register?
Were nursing home workers and patients in rural America taken into
consideration when crafting this policy? What did outreach to this
population specifically look like?
Why did the administration choose to not extend its COVID Public
Health Emergency policy which allowed nursing homes to train Temporary
Nurse Aides (TNAs) and allow for extra time for those TNAs to acquire
full training certification?
Answer. Understaffing continues to be a concern despite existing
requirements. For that reason, CMS believes it essential to patient
safety that it conduct new rulemaking to propose more specific,
detailed, and quantitative minimum staffing requirements.
CMS initially published a Request for Information (RFI) soliciting
public comments on minimum nursing home staffing requirements in April
2022, within the Fiscal Year (FY) 2023 Skilled Nursing Facility
Prospective Payment System Proposed Rule. CMS received over 3,000
comments from a variety of interested parties including advocacy
groups; long-term care ombudsmen; industry associations (providers);
labor unions and organizations; nursing home staff and administrators;
industry experts and other researchers; family members; and caretakers
of nursing home residents. The vast majority of comments received from
members of the public who identified themselves as family members or
caretakers of residents living in nursing homes voiced concerns related
to residents not receiving adequate care because of chronic
understaffing in facilities. Multiple commenters stated that residents
can go entire shifts without receiving toileting assistance, leading to
falls or increased presence of pressure ulcers. One commenter, whose
parents live in a nursing home, noted that they visit their parents on
a daily basis to ensure the provision of quality care and reported that
staff in the facility have stated that they are overworked and
understaffed.
The feedback received has and will be used to inform the research
study design for the mixed methods study that CMS is conducting with
qualitative and quantitative elements to help to inform the minimum
staffing proposed requirements. CMS seeks to consider all feedback from
the RFI responses, listening sessions, and mixed methods study in
crafting proposals for minimum direct care staffing requirements in
nursing homes. We expect to propose such requirements to advance the
public's interest in safe, quality care for residents in a 2023
rulemaking. CMS intends to seek workable, implementable solutions that
ensure safe, quality care for residents. CMS appreciates the interest
shown by so many stakeholders to date and looks forward to robust
response from stakeholders when the proposed rule is issued.
inflation caps
Question. Your budget calls for the expansion of several Inflation
Reduction Act policies from Medicare to the private market, one of
which is inflation caps on drug prices. I have been arguing for several
years at this point about the negative repercussions from placing
inflationary caps on drug prices--namely how they will almost surely
incentivize companies to launch their drugs at much higher prices than
they otherwise would have. Even CBO agrees--they said, ``the inflation-
rebate and negotiation provisions would increase the launch prices for
drugs that are not yet on the market relative to what such prices would
be otherwise.''
Why does HHS continue to move forward with the expansion of
policies that are proven to increase drug prices when the stated goal
is to decrease prices?
Answer. The Inflation Reduction Act requires manufacturers to pay
rebates to Medicare when drug prices for certain rebatable Medicare
Part B or Part D drugs rise at a rate that is faster than the rate of
inflation. The budget includes a proposal to revise the formula to
calculate these rebates beyond Medicare utilization to include drug
units used by commercial plans. Doing so would provide additional
savings while discouraging manufacturers from raising drug prices for
commercial coverage including employer-sponsored plans, marketplace
plans, and other individual and group market plans.
CMS cannot predict behavioral changes by drug manufacturers in
response to implementation of the inflation rebates for Part B and D
drugs. Our understanding is that manufacturers typically set their
drugs' launch prices to be competitive with other therapeutic and non-
therapeutic competitors.
``not scorable'' sections in the budget
Question. In going through the HHS budget in brief, I noticed
several instances that policy proposals are followed by ``[Not
Scorable].'' Would you be able to explain to me what that means to you?
Most of the time a section that ends in ``not scorable'' is filled with
promises of increased access to certain health services, meaning that
it is likely that additional resources are to be spent. I feel certain
that each of your proposed policies will surely increase Federal
spending in one way or another, meaning that they would ``score.''
Are the proposed and ``not scorable'' policies simply not detailed
enough to be able to receive full cost information or is HHS assuming
that these policies will not cost the Federal Government additional
funds? What measures are used to make such assumptions?
Answer. All proposals in the FY 2024 President's budget reflect the
official legislative agenda of the Biden administration. For the
Centers for Medicare and Medicaid Services (CMS), the Office of the
Actuary provides official estimates for legislative proposals affecting
Medicare, Medicaid, and other CMS programs. A proposal may not be
scorable due to multiple factors, in limited circumstances. For
example, the evidence supporting the policy may indicate a range of
potential effects on spending, both direct and indirect, that make it
difficult to provide a pinpoint estimate. In other instances, the
proposal leaves certain implementation details for future development
to account for stakeholder and other valuable input on how it would be
carried out, which also affects the ability to provide a pinpoint
estimate at the time of Budget publication.
The proposals in the FY 2024 President's budget each improve these
vital programs. The administration stands ready to work with Congress
on refinements and additional details that will support enactment.
ruling in fda v. alliance for hippocratic medicine
Question. As you know, last week, the U.S. District Court for the
Northern District of Texas held a hearing in the case FDA v. Alliance
for Hippocratic Medicine, which challenges the FDA's approval and
deregulation of a chemical abortion drug, mifepristone. Although a
decision has not been issued in that case yet, there have been some
calls for the FDA to ignore an injunction or a decision that would
restrict access to mifeprex while the litigation continues, should that
occur, and continue to distribute chemical abortion drugs regardless of
the Federal court's decision.
If a decision is issued in that case and that decision restricts
the distribution of chemical abortion drugs in any way, will you ensure
HHS's compliance with the decision of the Federal district court?
Answer. The FDA has determined that mifepristone is safe and
effective for medical termination of early pregnancy and we continue to
believe that patients should have access to FDA-approved medications
that FDA has determined to be safe and effective for their intended
uses. We stand by FDA's approval of mifepristone and will continue to
do everything we can to prevail in the courts. That said, HHS will
comply with all court orders.
federal funding for abortion
Question. I'm concerned by the priority HHS seems to be placing on
the taking of unborn human life, as opposed to providing actual health
care to save lives. Once again, the President's FY 2024 budget proposes
to eliminate the longstanding Hyde Amendment. Since it first became law
in 1976, the Hyde Amendment has saved over 2.4 million lives. The law
has been renewed every year since 1976 on a bipartisan basis, and
nearly 60 percent of Americans agree that taxpayer dollars should not
be used to fund abortion.
Assuming that Congress continues to maintain the Hyde Amendment,
like it has done for the last 47 years, will you commit to ensuring
that zero Federal dollars are used for elective abortion?
Answer. As HHS Secretary, my role is to implement the law. The
Department will follow all applicable laws as they relate to abortion
and any other issue.
title x funding
Question. In addition to Hyde, funding for the title X family
planning program, which under current regulation continues to fund
abortion-providers like Planned Parenthood, increased to by $225
million--from $286 million to $512 million.
Will you ensure that any amount appropriated by Congress to title X
is not used for abortion, consistent with Federal law prohibiting title
X dollars from being used for abortion? Considering title X dollars are
awarded to abortion providers, how will you ensure compliance with the
law?
Answer. The Department will follow all applicable laws as they
relate to abortion and any other issue. Title X recipients are required
to ensure that non-title X abortion activities are separate and
distinct from title X project activities. Where recipients conduct
abortion activities, the recipient must ensure that the title X-
supported project is separate and distinguishable from those other
activities. OPA monitors title X recipient compliance by conducting
ongoing monitoring calls and recipient correspondence, reviewing
recipient progress reports and continuation applications.
conscience protections
Question. We have had a number of conversations on protecting
conscience rights of individuals. Since 2004, Congress has continued to
include language on annual funding bills that prohibits funding to
entities that discriminate against institutions or individuals that do
not provide, pay for, provide coverage of, or refer for abortions.
Although you once referred to enforcement of this law as ``illegal,''
the President's budget includes the rider. Notably, the Proposed Rule
recently issued by HHS significantly walks back much of the clarity and
standards for implementation and enforcement of both the Weldon
Amendment and other conscience protection laws enacted by Congress that
the 2019 rule provided.
How much involvement did you have with issuing the rule? What steps
were taken to ensure the rule was issued manner free of conflicts of
interest?
Answer. HHS met with many faith-based leaders and stakeholders to
help inform work on this rule. In 2019, HHS issued a regulation that
provided broad definitions, created new compliance regulations, and
created a new enforcement mechanism for a number of statutes related to
the conscience rights of certain federally funded health-care entities
and providers. This regulation was held unlawful by three Federal
district courts. In light of these court decisions, and consistent with
the administration's commitment to safeguard the rights of Federal
conscience and religious nondiscrimination while also protecting access
to reproductive health care, HHS issued a proposed rule to partially
rescind the provisions of this rule that were deemed illegal in Federal
court, while reinforcing other processes previously in place for the
handling of conscience and religious freedom complaints. The proposed
rule issued in 2022 notably maintains provisions from the 2019 rule
issued by the Trump administration that provided clarity and standards
for enforcement of the Weldon Amendment, among the conscience statutes
the Department enforces.
Question. Recently, HHS Office for Civil Rights issued a
reorganization that appears to dissolve the Conscience and Religious
Freedom Division, among other divisions, and enfold that work into
separate, broader divisions.
What impact do you expect this reorganization will have on
investigating and enforcing conscience protection laws?
Answer. HHS expects this reorganization to have a positive impact
on our enforcement of conscience protection laws. In fact, the former
Deputy Director of the Conscience and Religious Freedom Division, Luis
Perez, is now the Deputy Director of the newly formed Enforcement
Division. In this role, he will be able to help OCR strategically carry
out enforcement activities and prioritize its needs, which importantly
includes enforcing Federal conscience protections. Further, the 2022
conscience proposed rule that OCR published proposed maintaining all of
the conscience statutes that were previously delegated to OCR for
enforcement.
Question. What impact do you expect this reorganization will have
on investigating and enforcing other civil rights laws, including
protections for individuals with disabilities?
Answer. HHS expects the reorganization to have a positive impact on
our enforcement of disability laws and other civil rights laws. The
former Deputy Director of the Conscience and Religious Freedom
Division, Luis Perez, is now the Deputy Director of the newly formed
Enforcement Division. He is a trained lawyer and litigator and will
help improve OCR's enforcement work, bring forward high impact matters
that help people, and help OCR enforce regulations including the HIPAA
Security Rule, which is an issue of national security.
Question. There has been much media coverage about the State of
California threatening to cut out health-care entities from partnership
with the State because they are not providing abortions either in
California or in other States, based on the laws in those areas or
Federal law, such as prohibitions on mailing chemical abortion drugs.
Has HHS OCR initiated an investigation into whether such
discrimination would violate the Weldon amendment?
Answer. OCR generally does not confirm or deny pending
investigations to protect the integrity of the investigation and work.
new york times report
Question. During the hearing, you testified that you were unaware
of the reporting that HHS could not locate at least 85,000
unaccompanied minors through their safety and well-being calls. This
number was reported in The New York Times, and the Departments of Labor
and Health and Human Services--within 2 days of this number being
reported--announced that they would be taking additional labor
enforcement efforts to ensure that unaccompanied minors are labor
trafficked.
Your Department took action in response to The New York Times
report, and you provided a statement in a joint DOL and HHS press
release on the matter.
Since February 23, 2023, were you briefed on The New York Times
report (Hannah Dreier, ``Alone and Exploited, Migrant Children Work
Brutal Jobs Across the U.S.'', New York Times, February 25, 2023,
https://www.nytimes.com/2023/02/25/us/unaccompanied-migrant-child-
workers-exploitation.html)? Please answer ``yes'' or ``no.''
If yes, did you receive any briefing regarding this matter in your
prep materials for this hearing? Please answer ``yes'' or ``no.''
Did you receive any briefings on the labor trafficking initiative
the Biden administration announced on February 27, 2023, either prior
to or subsequent to the rollout? Please answer ``yes'' or ``no.''
Did you receive any information on this labor trafficking
initiative in your prep materials for this hearing? Please answer
''yes'' or ``no.''
If you did receive information regarding The New York Times report
or the labor trafficking initiative, please explain to the committee
why you testified that you were unaware that HHS could not locate the
reported 85,000 unaccompanied minors.
Answer. The February 23, 2023, New York Times article that you
reference demonstrated the terrible ways that employers are exploiting
the economic situation that many children and families in the United
States find themselves in, including children who have previously been
in ORR care. HHS takes the issue of child labor very seriously. To that
end, we are committed to taking additional action to educate children
and our providers about child labor exploitation, ensure sponsors
understand the hazards of child labor, and collaborate with the
Department of Labor to do everything we can to reduce the likelihood
that children will end up in a situation where they are exploited. Our
principal responsibility is to care for unaccompanied children while
they are in our custody, and then make sure we can place the child to a
safe, vetted sponsor. HHS looks forward to partnering with Congress to
advance the shared mission of protecting children and continue to
strengthen the quality and depth of services we offer.
The Department does not believe it is accurate to say that 85,000
children are lost. ORR's custodial authority ends when a child is
released from ORR care. Per ORR policy, care providers must make at
least three safety and well-being calls to speak with the child and the
sponsor individually. Children and sponsors are not required to answer
these calls, and some do not. It is important to note that many sponsor
families may not answer a call from an unknown phone number or may
choose not to answer a call for a variety of reasons. Despite the
voluntary nature of the child's and sponsor's participation in safety
and well-being calls, in FY 2022, ORR care providers made contact with
either the child, the sponsor, or both in more than 81 percent of
households.
memorandum of agreement
Question. In 2018, HHS and DHS entered into a memorandum of
agreement to, in part, require ICE to share with HHS information
contained in ICE databases on the criminal and immigration histories of
potential sponsors and all adult members in sponsor households. The
intent of this MOA was to allow for HHS use additional information to
make more complete suitability determinations prior to placing a child
with an adult sponsor.
The Biden administration terminated this agreement and waived
background check requirements for household members living with
prospective sponsors. At the time, the Biden administration argued that
the old MOA ``undermined the interests of a child'' and that the new
MOA ``promotes the safe and timely transfer of children.''
In light of the recent New York Times story (Hannah Dreier, ``Alone
and Exploited, Migrant Children Work Brutal Jobs Across the U.S.'', New
York Times, February 25, 2023, https://www.nytimes.com/2023/02/25/us/
unaccompanied-migrant-child-workers-exploitation.html), will you be
updating your guidance regarding the vetting of sponsors? Please answer
``yes'' or ``no.''
If no, why not?
Answer. In June 2018, ORR, ICE, and CBP entered into an MOA that
set forth the expectations of the parties as they pertained to sharing
information about unaccompanied children at the time of referral from
ICE or CBP to ORR, while in the care and custody of ORR, including
during the vetting of potential sponsors, and upon release from ORR
care and custody. Section V of the 2018 MOA specified that ORR would
transmit sponsor fingerprints to ICE as part of its sponsor assessment
process. DHS would then perform criminal and immigration status checks
for all sponsor categories and provide the results to ORR prior to a
child's release from care. Prior to the 2018 MOA, ORR already
transmitted sponsor and other required subjects' fingerprints to the
Federal Bureau of Investigation (FBI) for adjudication in accordance
with its policies and procedures. This made the ICE biometric
background checks duplicative of ORR's FBI checks.
In late 2018, ORR reviewed the effects of the ICE biometric
background checks required under the MOA. The review assessed whether
they yielded any new information that enabled ORR to identify child
welfare risks that it would not have found under its standard policies,
including the FBI fingerprint background checks that were already
formerly part of ORR's vetting process for sponsors who were not
previously the child's primary caregiver. ORR also examined whether a
correlation existed between the ICE biometric background checks and a
child's length of stay in ORR care. ORR determined that none of the
information gleaned from duplicative ICE biometric background checks
yielded automatic sponsor disqualification or additional child safety
and welfare concerns, and in fact, had a negative influence on sponsors
coming forward to take custody of a child. Moreover, the sheer number
of sponsors and their household members requiring ICE biometric checks
resulted in lengthier time in care for children in ORR custody while
background check requests surged, creating long wait times to schedule
fingerprint appointments, and for those checks to be adjudicated. For
instance, median length of care for unaccompanied children discharged
to Category 1 sponsors increased from 20 days to 73 days between
January 5, 2018, and July 7, 2018. Based on its child welfare
expertise, ORR assessed that the ICE fingerprint checks were not in the
best interests of unaccompanied children in care.
In light of these findings, between December 2018 and June 2019,
ORR issued four operational directives that updated its background
checks processes to be consistent with pre-MOA policies. FBI
fingerprint background checks would only be required for all sponsor
categories and adult household members in cases where there were risks
to the child, the child was especially vulnerable, and the case was
being referred for a home study. Without such instances, Category 1
sponsors and Category 2A sponsors no longer required biometric-based
background checks. Lastly, close adult relative sponsors in Category 2
were broken into sub-classes of Category 2A and 2B, which affected
background check requirements for each. FBI fingerprint background
checks were and still are required for all Category 2B sponsors.
In March 2021, ORR formally rescinded the 2018 MOA. ORR, ICE, and
CBP signed a replacement MOA on consultation and information-sharing
policies. Its terms were the same as the 2018 version apart from the
removal of section V as it related to ORR sharing information with ICE.
ORR and DHS ensured that the information sharing provisions were
relevant to the safe and timely placement and transfer of children to
ORR care and ORR's discharge process.
ORR is dedicated to ensuring the safety and well-being of children
in its care from the moment they enter its custody, to when they are
safely placed with a vetted sponsor. ORR also understands the
importance of providing children and their sponsors with the PRS tools
and resources necessary to promote their safety. ORR provides PRS to
facilitate a continuum of care to unaccompanied children who would
benefit from ongoing assistance and to help them transition into their
new communities. PRS include timely referrals and connection to
community resources, as well as intensive services in cases where
support is needed to address a child's specific needs. These referral
and case management services are offered by a network of ORR-funded
non-profit providers across the United States. ORR has doubled the rate
of the total number of cases of PRS worked on in FY 2021 to more than
40 percent in FY 2022--all while receiving an unprecedented number of
referrals beginning in Calendar Year 2021. ORR continues to build PRS
capacity and is on track to provide nearly 50 percent of children
released from ORR care with PRS in CY 2023. These services are
fundamental in helping children and their sponsors establish resiliency
and access resources in their communities.
In order to fulfill its mission, ORR continuously evaluates its
unification policies and procedures to ensure that ORR is pursuing the
best interest of each child. Additionally, ORR conducted an audit of
the UC Program's current sponsor vetting requirements for potential
sponsors who have previously sponsored unaccompanied children to make
quality improvements where deemed appropriate without unnecessarily
keeping children in government-funded, congregate care settings. ORR
looks forwards to sharing the findings of the audit with the committee.
Question. Do you believe that a child, who has encountered
significant trauma during his or her journey to the border, should be
placed with unvetted sponsors? Please answer ``yes'' or ``no.''
Answer. No. Every child discharged from ORR care is vetted in
compliance with statute and in adherence to ORR's policies and
procedures. The safety and well-being of an unaccompanied child is the
primary factor in ORR release decisions. ORR's legal responsibility to
provide for the care and custody of unaccompanied children includes
robust sponsor vetting. Safe and timely release of unaccompanied
children to vetted sponsors is a multilayered process that involves the
identification of a sponsor, which is typically a parent or other
family member. The sponsor must then complete a robust screening
process that includes a sponsor application, interviews, sponsor
suitability assessments and reviews of supporting documentation,
background checks, and in some cases as required by ORR UC Program
Policy Guide section 2.4 (https://www.acf.hhs.gov/orr/policy-guidance/
unaccompanied-children-program-policy-guide-section-2#2.4), home
studies prior to release and PRS.
Question. Does the Department believe that it should vet every
adult individual who lives in a sponsor's household? Why or why not?
Answer. Pursuant to the TVPRA, ORR conducts background checks on
every sponsor to determine whether the proposed release is safe and the
sponsor can provide for the child's physical and mental well-being. The
process includes a public records background check of criminal history
and sex offender registry databases. Under current policy, if a public
records check reveals possible disqualifying factors under ORR UC
Program Policy Guide section 2.7.4 (https://www.acf.hhs.gov/orr/
resource/children-entering-the-united-states-unaccompanied-section-
2#2.7.4)--such as a documented risk to the safety of the unaccompanied
child, the child is especially vulnerable, or the case is being
referred for a home study--parents and legal guardians (also known as
Category 1 sponsors) and non-parent immediate family relatives (or
Category 2A sponsors) are fingerprinted, and the information is
submitted to the FBI prior to the child's release from ORR custody. All
other potential sponsors, like extended family members (Category 2B
sponsors) or unrelated sponsors and distant relatives (Category 3), are
fingerprinted and their information is submitted to the FBI for a
criminal history background check prior to a child's release from ORR
care. See ORR UC Program Policy Guide section 2.2.1 (https://
www.acf.hhs.gov/orr/policy-guidance/unaccompanied-children-program-
policy-guide-section-2#2.2.1).
In addition to verifying a sponsor's identity through background
checks, ORR conducts a thorough assessment of potential sponsors'
suitability in accordance with its statutory responsibilities. ORR's
policies with respect to the release process are described in its
online UC Program Policy Guide section 2 (https://www.acf.hhs.gov/orr/
policy-guidance/unaccompanied-children-program-policy-guide-section-2)
and in Field Guidance 10 (https://www.acf.hhs.gov/sites/default/files/
documents/orr/FG-
10%20Expedited%20Release%20for%20Eligible%20Category%201%20Cases%202021
%2003%2022.pdf) and 11 (https://www.acf.hhs.gov/sites/default/files/
documents/orr/FG-
11%20Temporary%20Waiver%20of%20Background%20Check%20Require
ments%202021%2003%2031.pdf). Requirements include proof of the sponsor-
child relationship, as well as the sponsor's ability to provide
protection from abuse, abandonment, neglect, and other harm. ORR and
care provider staff also evaluate a child's risk and resiliency factors
and their unique needs such as medical conditions or past experiences
in home country to determine a release decision based on child welfare
principles. These sponsor suitability assessments give ORR, through its
Federal Field Specialists, case managers, and field staff, the
individual decision-making and operational flexibility necessary to
make case-by-case determinations of what is in the child's best
interest and whether certain potential sponsors that are not Category
2B and 3 sponsors and adult household members needed to be
fingerprinted. Fingerprint background checks are still required for all
Category 2B and 3 sponsors.
In some cases, ORR also requires adult household members to undergo
a background check search of State child abuse and neglect (CA/N)
registries maintained by individual States. ORR routinely relies on its
State partner agencies to facilitate and adjudicate CA/N checks. States
independently own and operate their respective CA/N registry databases
and provide relevant information upon request to the agencies that ask
for them. As a result, timely CA/N check adjudication varies widely,
and ORR care providers' ability to vet every adult household member
with an additional check can depend on whether a particular State
partner can promptly facilitate the CA/N check without compromising
timely unification of children with their sponsors.
The Flores Settlement Agreement requires that children be released
from ORR care without unnecessary delay and to make prompt and
continuous efforts toward unification and the release of the child.
Once a sponsor is thoroughly vetted, due process protections entitle a
suitable sponsor to take custody of the unaccompanied child without
undue delay or procedural hurdles in line with child welfare best
practices. However, safety remains at the forefront of ORR's policies
and procedures, so without sacrificing safe and effective sponsor
vetting procedures, Case Managers also obtain information on adult
household members for purposes of such things as alternate caregiver
plans to ensure that the child is cared for if the sponsor ever becomes
unavailable. Case Managers are also trained to identify any safety
risks or vulnerability flags that would necessitate additional
background checks on adult household members, but that does not mean,
as a threshold matter, that children are unsafe should a sponsor live
with adult household members. Children experience better educational,
social, developmental, and health outcomes when they are surrounded by
familiar support systems that can often include extended family and
other individuals living within the same household, and have access to
comprehensive community resources, as opposed to being in more
restrictive, unfamiliar congregate care settings where they are more
likely to feel lonely, isolated, and confused about their
circumstances.
______
Questions Submitted by Hon. Steve Daines
drug price negotiation program and small molecule innovation
Question. The recent, partisan Inflation Reduction Act created the
Medicare Drug Negotiation Program, granting the HHS Secretary the
ability to negotiate drug prices in Medicare-covered drugs. The
negotiation process allows for small molecule drugs that are approved
as NDAs to become eligible for negotiation at 7 years after they
receive FDA approval, whereas biologics become eligible at 11 years.
This arrangement is questionable in light of the fact that small
molecule medicines accounted for a majority of new, life-saving
medicines and cures approved by the FDA in recent years. This drug
negotiation program would appear to stunt and disadvantage the
development of small molecule medicines which, notably, much of the
research and development for new oncology medicines is on small
molecules.
Is the administration concerned that the negotiation program as
currently designed will disadvantage or deter small molecule
advancements?
Given the promise shown for small molecules in the oncology space,
is the administration concerned that the negotiation program could
severely undermine the administration's own Cancer Moonshot initiative?
Small molecule drugs are more often dispensed at the pharmacy
counter, or sent to patients through mail orders, whereas biologics are
often physician-administered. Has HHS considered the impact of the drug
price negotiation program favoring biologics over small molecules in
light of the ongoing provider shortages across the country, especially
in more rural States like Montana?
How does the Department expect this will impact patient access to
medicines?
What analysis has the Department done to assess this dynamic?
Many small molecule medicines have the potential to address more
than one disease or treat broader patient populations, perhaps in
earlier lines of therapy, than solely the initial diseases and
populations approved at launch. Do you think CMS has the authority to
begin the ``negotiation'' eligibility clock upon the receipt of an
indication for a subsequent indication, after having received an orphan
drug negotiation exception for previous indication? Why or why not?
Answer. CMS supports continued drug innovation and believes it is
vitally important that beneficiaries have access to innovative new
therapies. The statute provides that drugs that have been approved by
the FDA for at least 7 years, or biologicals that have been licensed by
the FDA for at least 11 years, are eligible for negotiation. Any drugs
or biologicals selected for negotiation will have been on the market
for quite some time.
The law requires CMS to exclude certain orphan drugs approved or
licensed when identifying qualifying single source drugs, referred to
as the orphan drug exclusion. To be considered for the orphan drug
exclusion, the drug or biological product must: (1) be designated as a
drug for only one rare disease or condition by the FDA; and (2) be
approved by the FDA only for one or more indications within such
designated rare disease or condition. As noted in the initial guidance,
we are considering whether there are additional actions CMS can take in
its implementation of the Negotiation Program to best support orphan
drug development.
CMS has been regularly engaging with members of the public to get
their feedback so that we are implementing the Negotiation Program in a
thoughtful way that both improves drug affordability and accessibility
for people with Medicare and supports innovation. We plan to get public
input throughout the implementation of the Negotiation Program to make
sure that we know what is occurring in the market.
______
Questions Submitted by Hon. Todd Young
medicare coverage for innovative medical devices
Question. The Fall 2022 HHS Unified Agenda regulatory calendar
currently lists April 2023 as the target date for CMS to release the
Transitional Coverage for Emerging Technologies (TCET) proposed rule,
which would provide transitional Medicare coverage for new medical
technologies.
Can you assure us that CMS will issue the TCET proposed rule by
April 2023, particularly given that this rule was initially scheduled
for release in 2022, and originally discussed over 2 years ago when the
Medicare Coverage for Innovative Technology (MCIT) rule was repealed?
CMS indicated in the Medicare Coverage for Innovative Technology
(MCIT) repeal rule that ``breakthrough'' designation from the Food and
Drug Administration (FDA) alone would not necessarily result in a
technology having eligibility to undergo the TCET process.
Please describe the technologies CMS is considering could be
potentially eligible for coverage under the TCET.
How complex would eligible devices need to be? Would follow-on
devices potentially be eligible for Medicare coverage under the TCET?
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 has conducted 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.
medicare advantage
Question. CMS is considering policy to eliminate over 2,200 codes,
many of which are used to diagnose and treat chronic diseases commonly
experienced by low-
income seniors and people with disabilities, including depression,
vascular conditions, and heart disease. The American Medical
Association (AMA) and over 2 dozen patient disease groups have raised
concerns about the elimination of these codes and asked for a delay in
the implementation of this new model under further stakeholder
engagement is conducted.
Have you conducted an analysis on how this proposal would directly
impact providers and beneficiaries in each State and territory? Have
you analyzed how this proposal will impact the national health-care
workforce and physician shortage in each State and territory? Can you
share this analysis?
Will the administration provide assurances that the proposed policy
changes will not lead to increased beneficiary costs or disruption for
Medicare Advantage seniors in 2024?
Answer. In February, CMS proposed routine technical updates to
improve the accuracy of MA payments in the 2024 Advance Notice. The
proposed adjustments in some codes help to ensure that the risk
adjustment of MA payments better reflects a beneficiary's costs of
care, which means MA plans serving beneficiaries with greater health-
care needs would receive appropriately higher payments. The proposed
model updates do not impact coverage of Medicare services or
requirements for MA plans to deliver covered services; rather, these
proposed changes improve the accuracy of payments made to MA plans for
covering care for enrollees.
As required by law, CMS sought public comment on the CY 2024
Advance Notice and will take this feedback into account when finalizing
the Rate Announcement. CMS received a large number of comments in
response to the CY 2024 Advance Notice and appreciates the commenters
thoughts and input regarding payments under the MA program.
social determinants of health
Question. The Social Determinants Accelerator Act would establish a
Federal interagency council to better leverage existing programs and
address the barriers to coordination between health and social services
programs. The bill would also help States and localities to develop
innovative strategies to address social determinants in their
communities.
Have you considered establishing some sort of commission or
interagency council, like in the Social Determinants Accelerator Act,
to address potential SDOH barriers?
Answer. HHS agrees with the committee that addressing social
determinants of health is critical for improving health and well-being.
HHS is continuing our work with an intra-agency workgroup of multiple
HHS agencies and is also engaging in a White House-led Interagency
Policy Committee, which involves participation of multiple Federal
agencies to develop whole-of-government approaches to addressing social
determinants of health. A particular focus of the IPC's efforts has
been identifying opportunities to support the development and
sustainability of infrastructure needed to improve coordination of
health and social care services at the local level.
medicaid
Question. Last month, CMS released an Informational Bulletin
titled, ``Health-Care-Related Taxes and Hold Harmless Arrangements
Involving the Redistribution of Medicaid Payments'' which clarified
CMS's position on the use of health-care-
related taxes as a permissible source of Medicaid funding.
Can you discuss what prompted CMS to release this bulletin at this
time?
Does this bulletin reflect existing policy or is it a shift in
policy?
Can you confirm that the policies reflected in the bulletin will be
directed and applied to all States?
Answer. Recently, CMS has been approached by several States with
questions regarding the statutory and regulatory requirements
applicable to health-care-related taxes, including in connection with
proposals to implement or renew Medicaid managed care State directed
payments (SDPs). Many of these questions have focused on whether
health-care-related tax arrangements involving the redistribution of
Medicaid payments among providers subject to the tax would comply with
the statutory and regulatory prohibition on hold harmless arrangements,
as specified in section 1903(w)(1)(A)(iii) and (w)(4) of the Social
Security Act (the Act) and implementing regulations.
In response to these questions, in February 2023, CMS issued an
informational bulletin reiterating Federal requirements concerning
health-care-related taxes and hold harmless arrangements involving the
redistribution of Medicaid payments. This guidance, which does not
establish new policy, was issued as a reminder in response to questions
received from several States about complying with this provision of
law. CMS recognizes that health-care-related taxes often finance
critical programs that pay for care provided to Medicaid beneficiaries
and shore up the health care safety net, and it will continue to
approve permissible health-care-related taxes that meet Federal
requirements and remains committed to working with States.
______
Questions Submitted by Hon. Thom Tillis
Question. The President's budget requests an additional $100
million for the Food and Drug Administration's Center for Tobacco
Products to be paid for by extending user fees to manufacturers of
electronic cigarettes. This is in addition to the over $700 million the
FDA already receives from tobacco industry user fees on an annual
basis. The Family Smoking Prevention and Tobacco Control Act of 2009,
legislation which you supported during your tenure in Congress, gave
FDA the authority to regulate the tobacco industry. The act also
intended such user fees facilitate regulatory pathways that evaluate
alternative nicotine containing products and only those products
determined to be less harmful than continued cigarette smoking could be
sold in the marketplace.
However, since the law was enacted, FDA has only authorized 23
products or components of those products. Those authorizations were
granted well after the 180-day statutory deadline and there are still
literally hundreds of thousands of product applications pending at the
agency.
What assurances can you provide that these additional user fees
will improve CTP's regulatory review process? Unlike the other Centers
at the FDA that must achieve certain performance measures in order to
receive industry user fees, CTP does not have such requirements. Should
FDA take steps to align CTP with the other Centers, or should Congress
act to help ensure CTP is operating more effectively?
Answer. Since its inception, FDA has taken many actions to reduce
tobacco-
related disease and death, including taking steps to prevent and reduce
youth use of tobacco products, proposing tobacco product standards,
reviewing applications before new tobacco products can be legally
marketed, pursuing compliance and enforcement actions to hold companies
accountable, and educating the public about the risks of tobacco
products.
Last summer, to strengthen FDA's tobacco program, FDA Commissioner
Califf commissioned an external evaluation to be conducted by a panel
facilitated by the Reagan-Udall Foundation (RUF). The panel was asked
to assess the tobacco program's regulatory processes and agency
operations relating to regulations and guidance, application review,
compliance and enforcement, and communication with the public and other
stakeholders. The evaluation was completed in December 2022, and the
panel's report gave FDA helpful recommendations to build on CTP's
existing foundation and continue to grow and mature the program. The
RUF report included a specific recommendation for FDA to pursue
securing user fees from each sector regulated by the Center, including,
for example, Electronic Nicotine Delivery Systems. FDA is committed to
addressing all the recommendations outlined in the report, including
developing and implementing a comprehensive 5-year strategic plan,
which builds upon the foundation of CTP's previous strategic
priorities. FDA is committed to being transparent about our key
activities, which will ensure external stakeholders have a clear view
of our plans.
Your question raises concerns with the premarket application
process and timeliness in reviewing applications. CTP has made
important progress in reviewing Premarket Tobacco Applications (PMTA)
for tobacco products. To date, FDA has received PMTAs for nearly 26
million products, the vast majority of which are for e-cigarette
products, and successfully completed review of 99 percent of them. This
includes the applications for nearly 6.7 million products that were
received by the September 9, 2020, court-ordered submission deadline
(FDA has also completed review of 99 percent of those applications as
well). FDA continues to review the remaining one percent of
applications submitted by the September 9, 2020, deadline and is
committed to completing this as quickly as possible while making sure
final decisions are legally defensible and grounded in science.
FDA acknowledges that there are opportunities to enhance the PMTA
review process and has started developing a more efficient framework
for high-quality tobacco product application reviews, which will, for
example, improve review times. CTP's goals are to work internally and
through engagement with external stakeholders to: better communicate
scientific issues and review processes to support efficiency,
effectiveness, and transparency; hire additional staff to enhance
program management and implementation, including for application
review; and increase internal communication to improve scientific
engagement and deliberation. These efforts include activities such as
resuming posting of scientific policy memos and reviewer guides, when
appropriate, and communication through public events, such as workshops
and listening sessions.
FDA is committed to transparency and accountability and regularly
reports to the public and Congress on premarket review progress.
This important work cannot be done without sufficient resources.
Currently, section 919 of the Federal Food, Drug, and Cosmetic (FD&C)
Act (21 U.S.C. 387s) authorizes FDA to assess user fees on tobacco
products that fall within the following six product classes: cigars,
pipe tobacco, cigarettes, snuff, chewing tobacco, and roll-your-own
tobacco. Section 919 also authorizes the total amount of user fees FDA
must assess and collect each year. For the first 10 years of the FDA
tobacco program, the total amount of user fee collection increased each
year; however, beginning in Fiscal Year 2019, the authorized amount of
$712 million is fixed for each subsequent fiscal year and is not
indexed to inflation. Further, section 919 of the FD&C Act does not
provide FDA the authority to assess and collect user fees for ENDS,
which includes e-cigarettes, and certain other deemed products. Thus,
FDA has had to spend a significant portion of the $712 million in user
fees it collects annually from the existing six product classes to
properly regulate deemed products, especially ENDS.
FDA's request to extend user fees to ENDS and deemed products would
ensure a more equitable distribution of user fees across industry. In
addition, the request for an additional $100 million in user fees,
indexed to inflation, is in line with ensuring comprehensive regulation
of the changing tobacco product marketplace. The additional $100
million will enable FDA to expand much-needed activities in the
critical areas of compliance and enforcement, product review,
scientific research, regulation and guidance development, and public
education.
Question. Recently, the National Center for Advancing Translational
Sciences (NCATS) and the Food and Drug Administration have publicly
acknowledged an urgency to speed solutions for rare disease patients by
developing treatments for more than one rare disease at a time.
However, the limited nature of the Inflation Reduction Act's orphan
drug exemption would discourage future research programs of existing
rare disease therapies into additional orphan indications due to the
risk of losing the exemption.
Please detail how HHS plans to take a ``whole agency approach'' to
ensure future research and development for patients with rare diseases
and conditions without a treatment.
Answer. FDA remains strongly committed to doing what we can via
guidance for industry and stakeholder engagement activities to maintain
and promote the robustness of the development pipeline for safe and
effective drugs and biological products to treat patients with rare
diseases, including rare cancers. FDA has published more than 18
guidance documents since 2018 on topics that are highly relevant to
drug and biological product development for rare diseases, including
rare cancers. Some recent examples include:
2023 Draft Guidance for Industry: Clinical Trial
Considerations to Support Accelerated Approval of Oncology
Therapeutics.\82\
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\82\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/clinical-trial-considerations-support-accelerated-
approval-oncology-therapeutics.
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2023 Draft Guidance for Industry: Considerations for the
Design and Conduct of Externally Controlled Trials for Drug and
Biological Products.\83\
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\83\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/considerations-design-and-conduct-externally-
controlled-trials-drug-and-biological-products.
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2022 Guidance for Industry: Human Gene Therapy for
Neurodegenerative Diseases.\84\
---------------------------------------------------------------------------
\84\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/human-gene-therapy-neurodegenerative-diseases.
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2022 Draft Guidance for Industry: Tissue Agnostic Drug
Development in Oncology.\85\
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\85\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/tissue-agnostic-drug-development-oncology.
Of note, with regard to FDA and NIH ``developing treatments for
more than one disease at a time,'' both agencies, along with several
other entities, are working collaboratively to expedite development of
gene therapies for rare diseases that are caused by a single genetic
mutation and for which there is no commercial interest in developing
therapies due to each disease's rarity. This effort, the Bespoke Gene
Therapy Consortium, focuses on developing common gene therapy platforms
and standards that can be used in the manufacture of several different
gene therapies, each for a different rare disease, and thus would
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increase efficiency overall.
Further, NIH, and NCATS remain committed to supporting research to
find treatments and cures for rare diseases and conditions without a
treatment, and to increase the speed of therapeutic and diagnostic
development. At NIH, NCATS's Division of Rare Diseases Research
Innovation provides leadership, coordination and collaboration on rare
disease research programs across the NIH. Research on specific rare
diseases is supported by many NIH Institutes, Centers, and Offices
(ICOs) as falls within their respective missions.
NCATS supports rare disease research projects with applicability to
many diseases at a time, and works with other HHS operating divisions
to ensure appropriate resources and expertise are being applied. One
such program involving cross agency collaboration and targeting rare
diseases is the Bespoke Gene Therapy Consortium (BGTC), a partnership
with the Food and Drug Administration (FDA) and the Foundation for the
National Institutes of Health (FNIH), NCATS and 10 other NIH Institutes
and Centers (ICs), and several pharmaceutical companies and nonprofit
organizations, that will streamline gene therapy development and
products for rare disorders of no commercial interest. For BGTC
clinical trials, scientists will develop strategies for streamlining
the regulatory processes for FDA approval of safe and effective gene
therapies, and they will develop standardized approaches to preclinical
testing. BGTC has narrowed the potential diseases to be studied to 14,
and proposals for clinical trials are being reviewed, with the 5-6
chosen trials to be announced in May 2023.
Another collaborative research initiative is the NIH Common Fund's
Somatic Cell Genome Editing (SCGE) program, led by NCATS and the
National Institutes of Neurological Disorders and Stroke (NINDS). Phase
1 of the program aims to develop high-quality tools for performing safe
and effective genome editing in humans and then make these tools widely
available to the research community to reduce the time and cost of
developing new therapies. Based on the success of Phase 1, the Common
Fund approved a second phase of the program, which will be focused more
on accelerating somatic genome editing clinical trials. Applications
have been reviewed, and funded projects will be announced shortly. FDA
collaborated with the SCGE program throughout Phase 1, and given the
greater focus on clinical trials in Phase 2, the NIH and FDA plan to
establish a memorandum of understanding (MOU) to efficiently translate
the results from Phase 2 projects into the clinic.
Question. The Inflation Reduction Act exempts an orphan drug
indicated for a single rare disease/condition from Medicare price
negotiation.
Please clarify when the Medicare negotiation eligibility clock
begins for a drug that loses the orphan drug exemption due to approval
for an additional indication.
Answer. CMS supports continued drug innovation and believes it is
vitally important that beneficiaries have access to innovative new
therapies. We are striving to implement the Negotiation Program in a
thoughtful way that both improves drug affordability and accessibility
for people with Medicare and supports innovation.
The law requires CMS to exclude certain orphan drugs approved or
licensed when identifying qualifying single source drugs, referred to
as the orphan drug exclusion. To be considered for the orphan drug
exclusion, the drug or biological product must (1) be designated as a
drug for only one rare disease or condition by the FDA, and (2) be
approved by the FDA only for one or more indications within such
designated rare disease or condition. As noted in the initial guidance
for the Medicare Drug Price Negotiation Program for initial price
applicability year 2026, CMS is still considering whether there are
additional actions CMS can take in its implementation of the
Negotiation Program to best support orphan drug development. The agency
will continue to keep Congress and relevant stakeholders updated as we
move forward.
Question. Value-based care is a bipartisan issue and a model many
of us on this committee support as one way to meet our obligations to
seniors but also to bring down costs. The administration has set a goal
of having as many Medicare beneficiaries as possible in value-based
care by 2030.
I'm concerned about the potential chilling effect of the Medicare
Advantage Advance Notice on risk adjustment for providers that take on
full risk--as MA is the primary place that can happen--particularly in
underserved areas in NC.
How do you see the risk adjustment changes affecting value-based
provider access for Medicare beneficiaries in underserved areas,
particularly for duals? There are several provider organizations,
including ones that operate in my State, saying the proposed changes
will reduce resources for dually eligible Medicare beneficiaries.
Answer. The proposals in the Advance Notice improve payment
accuracy to ensure MA plan payments better reflect the expected costs
of care, with higher payments going to plans serving people with
greater health-care needs. This helps ensure that people in MA can
continue to access the care they need.
Additionally, there are protective features built into the MA risk
adjustment system to ensure that plans caring for dually eligible
individuals are paid adequately, and nothing in this proposal changes
those features. We will continue to pay much more for someone who is
dually eligible than someone who is not, even when they have the same
diagnoses. These higher payments decrease incentives for plans to favor
healthier enrollees or discriminate against sicker patients.
To the extent beneficiaries who are low-income or who are living in
rural or underserved areas have greater health-care needs, the proposed
model would better compensate plans for that care. Furthermore, Federal
law protects most dually eligible individuals from any cost sharing for
Medicare services, so specific plans changes in cost sharing cannot be
passed onto those dually eligible beneficiaries.
CMS anticipates stable premiums and benefits for beneficiaries in
2024, as seen previously in years with comparable updates. For example,
in 2015, MA plans experienced a payment increase of 0.4 percent
compared to 2014. Following those payment updates, the MA market
remained strong and continued to grow. Historical experience shows
plans compete in this highly competitive market to keep premiums down
and maintain supplemental benefit levels, with beneficiary choice
remaining strong.
Question. As you are aware, the President's budget proposes further
expanding the price-setting program to 5 years after approval for all
drugs. This is concerning as some studies show that a full 50 percent
of investments in all drugs are recouped in years 9 through 13.
Can the administration provide data that shows R&D investments in
complex drugs (like those aimed at treating diseases like cancer and
Alzheimer's) can be recouped in just 5 years?
What is the Department's estimate of the number of fewer new drugs
as a result of the expansion of the negotiation program?
Answer. The President's budget proposal builds on the Inflation
Reduction Act by increasing the number of drugs subject to negotiation
and making drugs eligible for negotiation sooner after their launch.
Expanding the Drug Price Negotiation Program accelerates the increased
gains in access for Medicare beneficiaries to innovative, life-saving
treatments enacted by the law, with lower costs for people with
Medicare and the program.
Question. My State is home to some of the strongest universities in
the Nation, and the research and development they undertake every day
creates scores of new jobs, bolstering our economy and advancing our
global leadership in biomedicine, along with numerous other fields. The
expansion of the negotiation program included in the President's budget
could demolish or downsize many of the public-
private partnerships that enable these institutions to innovate.
How would your administration's proposal impact biomedical research
and development--in numerical terms--and what would the downstream
effects be for public-private partnerships and research hubs like the
ones North Carolina?
Answer. On March 15, 2023, CMS issued initial guidance detailing
the requirements and parameters of the Medicare Drug Price Negotiation
Program, including requests for public comment on key elements, and
announced the next steps for how the agency will implement the new
program for 2026. In the initial guidance, CMS laid out an approach to
negotiation that will focus on key questions, including but not limited
to the selected drug's clinical benefit, the extent to which it
fulfills an unmet medical need, and its impact on people who rely on
Medicare. The statute requires that CMS consider certain manufacturer-
specific data, including research and development costs and recoupment
of those costs, and available evidence about alternative treatments, as
the basis for determining offers and counteroffers for a selected drug
under the Negotiation Program. We are going to be considering the
negotiation factors outlined in the law very seriously. We are striving
to implement the Negotiation Program in a thoughtful way that both
improves drug affordability and accessibility for people with Medicare
and supports innovation.
Question. The administration has allocated additional funding to
expand access to telehealth, especially in rural and underserved areas.
Further, through the passage of the Consolidated Appropriations Act of
2023, Congress extended pandemic expanded telehealth access to the end
of 2024.
What changes in law are required to continue providing flexibility
to enable expanded access beyond 2024 in rural and underserved areas?
Answer. In response to the COVID-19 public health emergency, which
is set to expire in May 2023, flexibilities for Medicare telehealth
services were issued through legislative and regulatory authorities to
increase access to care for patients and providers. The Consolidated
Appropriations Act of 2023 recently extended many of these
flexibilities through December 31, 2024. Extended telehealth
flexibilities include waiving geographic and site of service
originating site restrictions so that Medicare patients can continue to
use telehealth services from their home and allowing audio-only
telehealth services. Additionally, the expanded list of providers
eligible to deliver telehealth services is also extended so Medicare
beneficiaries can continue to receive telehealth services furnished by
physical therapists, occupational therapists, speech language
pathologists, and audiologists, as well as receive telehealth services
from Rural Health Clinics and Federally Qualified Health Centers
through December 31, 2024. If you are interested in drafting
legislation to make these waivers permanent, CMS would be happy to
provide technical assistance.
Additionally, recent legislative and regulatory changes made
several telehealth flexibilities permanent. Federally Qualified Health
Centers and Rural Health Clinics can furnish certain mental health
services via telecommunications technology. Medicare patients can
continue to receive these telehealth services in their home as
geographic restrictions on the originating site are eliminated for
these telehealth services. Certain mental health telehealth services
can be delivered using audio-only communication platforms, and rural
emergency hospitals can serve as an originating site for telehealth
services.
For Medicaid and CHIP, telehealth flexibilities are not tied to the
end of the PHE and have been offered by many State Medicaid programs
long before the pandemic. Medicaid and CHIP telehealth policies will
ultimately vary by State. CMS encourages States to continue to cover
Medicaid and CHIP services when they are delivered via telehealth.
______
Questions Submitted by Hon. Marsha Blackburn
Question. We have a profound responsibility, through our Federal
health-care programs, to address the needs of Americans with
disabilities, as well as seniors and those living with debilitating
conditions--including rare diseases.
Unfortunately, several bureaucratic and controversial measures--
such as using so-called quality-adjusted life years, or QALYs--
undermine that broadly bipartisan mission. As explained by the National
Council on Disability, ``QALYs place a lower value on treatments which
extend the lives of people with chronic illnesses and disabilities.''
Patient advocates across the board have echoed these concerns for
years, especially given the access gaps and barriers created by the use
of these discriminatory metrics in other countries, particularly in
Europe.
For that reason, I recently joined a group of my colleagues in
urging your department--and the administration more broadly--to
eliminate the use of QALYs and other similar measures, both directly
and indirectly, across our Federal health-care programs.
Given the long history of bipartisan opposition to QALYs, can you
commit to working with me and my colleagues, as well as your
counterparts in other departments, to prevent the application of these
types of metrics across all Federal programs?
Answer. It has been a longstanding policy that Medicare does not
use QALYs, in accordance with the law. We are happy to provide
technical assistance on any legislation you draft.
Question. The price controls imposed under the Inflation Reduction
Act (IRA) have the potential to damage biomedical research and
development, erode access to future treatments, and hand a competitive
edge to our other global rivals. The law's impact on innovation in
small-molecule drugs, which hold promise for addressing diseases like
Alzheimer's and cancer, will prove particularly devastating. In fact,
the majority of manufacturers have already reported plans to shift R&D
away from these types of products due in part to the shorter exemption
period for these drugs under the IRA's government price-setting
program. I strongly support efforts to extend this exemption period
from 9 years to 13, ensuring parity between small molecules and
biologics.
To that end, last month, I joined Senator Menendez in introducing
the Maintaining Investments in New Innovation Act, which would provide
this type of extension for gene-targeting therapies. I hope we can find
bipartisan support for an even broader proposal to capture the full
range of life-saving small-molecule drugs. If Congress fails to act on
this front, patients--and especially seniors--will inevitably suffer.
Can you commit to working with Congress to mitigate the harmful
effects of the IRA's government price-setting program?
Answer. We are striving to implement the Negotiation Program in a
thoughtful way that both improves drug affordability and accessibility
for people with Medicare and supports innovation. We are happy to
provide technical assistance on your legislation.
Question. The ``maximum fair price'' (MFP) risks spillover beyond
Medicare (``commercial spillover'') in two ways: (1) diversion, when
Medicare and 340B status may not be established and when the
organization dispenses/administers to a patient contrary to law; and
(2) reimbursement challenges, when commercial payers may seek to adjust
to MFP-based reimbursement for non-MFP-eligible individuals, thus
compromising patient access to therapies. MFP is also explicitly
included in Best Price reporting, which could lead to price erosion in
non-Medicare markets.
Given that the IRA is intended to apply solely to Medicare and its
beneficiaries, how will the administration assure that its mandated
prices will not ``spill over'' and manipulate commercial and other non-
Medicare markets?
As the administration works to implement the IRA's government
price-setting program, will CMS commit to providing multiple notice and
comment rulemaking periods, with reasonable time constraints, and
assurance that CMS will respond to public comments to allow patient
groups, manufacturers, and other stakeholders to have the ability to
provide meaningful input?
Answer. The Inflation Reduction Act requires manufacturers to
provide access to the prices negotiated (i.e., maximum far prices) for
the selected drugs when Medicare beneficiaries receive these drugs.
There is no requirement for manufacturers to provide access to the
maximum fair prices (MFPs) when commercially insured individuals
receive these negotiated drugs.
On March 15, 2023, CMS issued initial guidance detailing the
requirements and parameters of the Negotiation Program, including
requests for public comment on key elements, and announced the next
steps for how the agency will implement the new program for 2026. As
described in the initial guidance, CMS intends to require the
manufacturers ensure that entities that dispense drugs to those MFP-
eligible individuals, including pharmacies, mail order services, and
other dispensers, have access to the MFP for the selected drug, in
accordance with the law. CMS intends to define ``providing access to
the MFP'' as ensuring that the amount paid by the dispensing entity for
the selected drug is no greater than the MFP. As part of the initial
guidance, CMS is seeking comment on how such a process would operate
most effectively, including suggestions on ways that CMS could provide
technical assistance to entities to ensure they are able to provide the
MFP to MFP-eligible individuals and ways to ensure that MFP-eligible
individuals whose cost-sharing was not consistent with MFP are made
whole.
The Inflation Reduction Act requires that CMS implement the
Negotiation Program for 2026, 2027, and 2028 by program instruction or
other forms of program guidance. CMS recognizes that public input is
essential for successful implementation. CMS has sought and will
continue to seek feedback and insights from a wide range of interested
parties throughout the implementation of the Inflation Reduction Act,
including but not limited to comment on this initial guidance. Public
feedback will contribute to the success of the Negotiation Program, and
the initial guidance is one tool, among many, CMS will use to ensure
interested parties' voices are heard on implementation of the new drug
law. More information on how to submit comments can be found in the
initial guidance. Comments received by April 14, 2023, will be
considered for revised guidance. CMS anticipates issuing revised
guidance for the first year of negotiation in Summer 2023.
Additionally, this guidance is only for implementing drug price
negotiation for initial price applicability year 2026. CMS is
continuing to take feedback for future years of the program.
Question. For decades, robust competition from generic drugs has
cut costs for American patients from all walks of life. Generics
currently account for 90 percent of all prescriptions filled in the
U.S. and our generic drug prices are lower than virtually any other
developed nation. Biosimilars have the potential to drive similarly
strong cost savings among higher-cost medications. The FDA has approved
at least 40 biosimilars, driving down prices for patients at the
pharmacy counter and the doctor's office.
However, I am concerned that the IRA's government price-setting
program will reverse this trend and destroy the growing biosimilar
market, resulting in higher health-care spending for consumers and
taxpayers. During consideration of the IRA, I filed an amendment to
shore up the biologic delay provision under the price-
setting program, given that the current language seems entirely
unworkable for biosimilar development timelines. This is not a partisan
proposal but rather a technical improvement that I hope to introduce as
standalone legislation in partnership with my colleagues on both sides
of the aisle.
Can you commit to working with me and with Congress more broadly to
fix the IRA's special rule for delaying price-setting for biologics
subject to impending competition, given the importance of promoting
biosimilars?
Answer. CMS acknowledges and prioritizes the importance of
promoting biosimilars. We are implementing the Drug Price Negotiation
Program under the Inflation Reduction Act, including the special rule
to delay the selection and negotiation of certain biological products
when there is a high likelihood that a biosimilar biological product
(for which such biological product will be the reference product) will
be licensed and marketed within 2 years in accordance with the law. We
are happy to provide technical assistance on your legislation.
Question. Patent protections are enshrined in our Constitution and
have provided the driving incentive for most life-saving medical
breakthroughs. The IRA's government price-setting program risks eroding
intellectual property protections for American inventors, small
businesses, and entrepreneurs. I have serious concerns with efforts to
weaponize Federal programs and laws to undermine IP.
Attempts to repurpose and distort the Bayh-Dole Act framework to
seize American patents and impose sweeping price controls would destroy
the partnerships responsible for many of our most groundbreaking
treatments and cures. Senators Bayh and Dole both asserted as much for
years, making clear that the so-called ``march-in'' provisions under
their landmark law were never intended to enable Federal price-fixing.
Can you commit to adhering to the law--and the express intent of
its bipartisan drafters--and reject efforts to misuse march-in rights
to dictate price controls for medications?
Answer. The Bayh-Dole Act was designed to promote the
commercialization of research results, maximize the potential for
federally-funded technologies to become products, and serve the broader
interest of the American public. HHS is committed to implementing the
law and upholding these aims to support the innovation needed to
deliver new and effective drugs to patients. To that end, HHS has
partnered with the Department of Commerce to review the use of march-in
authority as laid out in the Bayh-Dole Act. Through this partnership,
we have asked an Interagency Working Group to develop a framework for
consistent implementation of the march-in provision across the U.S.
Government that clearly articulates guiding criteria and processes for
making determinations where different factors, including price, may be
a consideration in agencies' assessments. HHS will convene a workshop
in 2023 to further refine the cases for which HHS could consider
exercising march-in authority. HHS will seek input from a diverse array
of interested parties--including patient groups, industry,
universities, small business firms, and nonprofit organizations, as
well as experts in technology transfer and innovation policy. The goal
of the workshop will be to assess when the use of march-in rights is
consistent with the policy and objectives of the Bayh-Dole Act.
Question. Many therapies initially approved for a single indication
go on to secure multiple indications, which is common among oncology
drugs. The IRA arbitrarily applies the government price-setting mandate
on a drug after the applicable exclusivity period regardless of follow-
on indications. I am concerned that this disincentivizes manufacturers
from performing additional clinical trials and pursuing other
indications.
How will CMS ensure that innovation is unaffected, and
manufacturers can continue post-approval development to realize the
full breadth of a drug's potential benefit?
Answer. CMS supports continued drug innovation and believes it is
vitally important that beneficiaries have access to innovative new
therapies. We are striving to implement the Negotiation Program in a
thoughtful way that both improves drug affordability and accessibility
for people with Medicare and supports innovation.
The law requires CMS to exclude certain orphan drugs approved or
licensed when identifying qualifying single source drugs, referred to
as the orphan drug exclusion. To be considered for the orphan drug
exclusion, the drug or biological product must (1) be designated as a
drug for only one rare disease or condition by the FDA, and (2) be
approved by the FDA only for one or more indications within such
designated rare disease or condition. As noted in the initial guidance,
we are still considering whether there are additional actions CMS can
take in its implementation of the Negotiation Program to best support
orphan drug development.
Question. In enacting the No Surprises Act, Congress included the
Qualifying Payment Amount (QPA) as only one of the several factors to
be considered in the IDR process. The Federal Courts have twice
admonished HHS about the bias toward the QPA. Yet, the administration
has not taken basic corrective action against this tilting of the
playing field in favor of insurers.
Do you now agree to clarify through guidance that the rates used to
calculate the QPA must be the median of the contracted rates ``paid''
by the plan in January 2019?
Because regulation gives primacy in the dispute resolution process
to these QPAs, insurance companies have uniformly refused to negotiate
with providers during the 30-day negotiation period established in the
law.
In your opinion, which party is better prepared to weather long
periods of cashflow delay, doctors or insurers?
While audits will not solve the manipulation of median prices, they
are critical to ensuring a full and fair arbitration process.
Why has HHS not yet moved forward with implementing section 102 of
the No Surprises Act, which requires establishing an auditing process
for health insurers effective October 1, 2021?
Answer. CMS is committed to implementing the No Surprises Act (NSA)
consistent with the law. Certified Independent Dispute Resolution (IDR)
entities are required to consider the qualifying payment amount (QPA)
and certain additional factors when selecting between the offer
submitted by a plan or issuer and the offer submitted by a facility,
provider, or provider of air ambulance services when determining the
total out-of-network payment rate for items and services subject to the
Federal IDR process. The QPA for a given item or service generally is
the median contracted rate on January 31, 2019 for the same or similar
item or service, increased for inflation.
The standards governing a certified IDR entity's consideration of
information when making payment determinations for disputes involving
items or services furnished on or after October 25, 2022 are provided
in the August 2022 final rules, as revised by the opinion and order of
the U.S. District Court for the Eastern District of Texas in Texas
Medical Association, et al. v. United States Department of Health and
Human Services et al., Case, No. 6:22-cv-372 (February 6, 2023). As of
March 17, 2023, the Departments have completed the necessary updates to
the Federal IDR portal and Federal IDR process guidance documents to
reflect these revised payment determination standards.
Additionally, consistent with section 102 of the No Surprises Act,
the Departments outlined the QPA auditing requirements in Requirements
Related to Surprise Billing, part 1 (July 13, 2021) and CMS is
conducting QPA audits on behalf of all departments to ensure that plans
and issuers are complying with requirements related to the calculation
and disclosure of the QPA. The NSA requires the departments to submit a
report to Congress for each year in which audits were conducted. The
departments are actively conducting QPA audits as required under the
statute and intend to produce the reports to Congress required in the
law.
Question. Over half of the Medicare care beneficiaries in Tennessee
rely on Medicare Advantage plans--around half a million Tennesseans.
Many of these beneficiaries are low-income and in rural parts of the
State where the extra benefits, like health programs and additional
support for those with disabilities, are especially important. This
administration seems dead set on pushing policies that harm the
Medicare Advantage program, like the recently proposed cuts to the
program, which will decrease benefits for some of Tennessee's most
vulnerable, like those in special needs plans.
Is the Department concerned that its recent payment determinations
will affect care for Medicare Advantage beneficiaries, which account
for more than half of all Medicare enrollees nationwide?
Answer. As required by law, CMS adjusts payments to health plans
offering MA to reflect the expected health-care costs of enrollees
based on health status and demographic characteristics through a
process known as ``risk adjustment.'' This ensures CMS pays more for
enrollees with greater health-care needs and reduces incentives for
plans to favor healthier beneficiaries. CMS routinely makes updates to
the MA risk adjustment model to reflect more recent utilization and
cost patterns and to ensure MA payments accurately reflect the costs of
care for MA enrollees. In February, CMS proposed routine technical
updates to improve the accuracy of MA payments in the 2024 Advance
Notice. CMS received public feedback on these proposals, and will take
this feedback into account when finalizing the 2024 Rate Announcement.
Question. The President's budget proposes to increase funding for
the title X family planning program from $286 million to $512 million.
The title X program has been called a slush fund for abortion
providers, like Planned Parenthood, who are expected to receive tens of
millions annually from this program now that your rule, allowing
grantees to be collocated with abortion clinics, has taken effect.
A January 2023 Marist poll found that 60 percent of Americans
oppose using tax dollars to fund abortions. Why do you continue to
subsidize the abortion industry despite most Americans opposing using
their tax dollars for this purpose?
How much Federal funding have abortion groups like Planned
Parenthood received from HHS since you became the Secretary?
Answer. As HHS Secretary, my role is to implement the law. The
Department will follow all applicable laws as they relate to abortion
and any other issue.
Question. Millions of Americans are living with limb loss and limb
difference. Despite the robust size of this population, policymakers
know very little about how the health care delivery system serves
individuals as they navigate the unique challenges they confront. To
address this shortcoming, with Senator Duckworth and Representatives
Guthrie and Butterfield, I introduced the Triple-A Study Act in the
last Congress, asking GAO to study how Medicare and Medicaid are
meeting the needs of the limb loss and limb difference community. GAO
has begun its work, and we expect the study to be completed later this
year.
As we learn more from GAO regarding gaps in care and opportunities
for improvement, can we count on you to work with us to ensure that the
limb loss and limb difference community has access to the high-quality
care they expect and deserve from the Medicare and Medicaid programs?
Answer. CMS looks forward to reviewing this study from the working
with the GAO on this review and we would be happy to work with you on
this issue, including providing technical assistance on any legislation
you draft.
Question. I've written to CMS Administrator Chiquita Brooks-LaSure
about the need to provide coverage of important technologies for people
with serious disabilities like ALS, MS, and spinal cord injuries. I
appreciate your team proposing that Medicare cover seat elevation
systems for people with disabilities, but I encourage you to finalize
this important coverage decision.
Will you commit to issuing a similar coverage proposal for standing
systems that help people with disabilities perform activities of daily
living and avoid costly complications?
Answer. In February 2023 CMS published a proposed National Coverage
Determination (NCD) to expand Medicare coverage for power seat
elevation equipment for individuals with a Group 3 power wheelchair.
The public comment period closed on this NCD last month. CMS plans to
consider standing equipment in a separate future national coverage
analysis. I'm happy to stay in touch with you as CMS undertakes this
process.
Question. In your first 2 years as Secretary leading the department
responsible for overseeing the Federal response to the COVID-19
pandemic that has claimed the lives of over 1 million Americans, have
you ever spent an extended period working from California?
What percentage of your time have you spent in California in your 2
years as Secretary?
Can the Department commit to proactively sharing documents released
through FOIA related to the Secretary's calendars and travel that are
``frequently requested'' (described in subsection (a)(2) of Sec. 552 as
records having been requested three or more times) with my office?
Answer. HHS is incredibly proud of the work that HHS has
accomplished during this administration. This is a 24/7 job and I treat
it as such, whether I am in an office building, on domestic or
international official travel, or teleworking. As always, our north
star will continue to be delivering on our mission which means building
on the innovations and technology that we have put to work to ensure we
are enhancing the health and well-being of all Americans.
HHS is committed to transparency and to working in good faith to
address members' requests for information.
Question. Digital health technologies, including clinical decision
support software, software as a medical device, patient remote
monitoring, and AI-enabled services, have already improved patient
outcomes and provider efficiency.
What is CMS's strategy to address this emerging field of medicine
and adequately incorporate digital health technologies into the
Medicare payment systems across all settings?
Answer. Thank you for your interest in expanding access to digital
technologies in Medicare. President Biden's Fiscal Year 2024 budget
includes a proposal that would allow for Medicare coverage of evidence-
based digital applications and platforms that facilitate greater access
to behavioral health services, especially for beneficiaries who live in
rural or health professional shortage areas. If you are interested in
drafting legislation to address Medicare's coverage of digital
technologies, CMS would be happy to provide technical assistance.
Question. Section 218(b) of the Protecting Access to Medicare Act
of 2014 directed the HHS Secretary to establish AUC program by January
1, 2017 with a relevant clinical decision support mechanism (CDSM) to
assess the appropriateness of imaging services based on a patient's
needs. Congress intended for the AUC program to ensure the best
possible high-value imaging to patients, while avoiding unnecessary or
duplicative procedures. It has been over 8 years since PAMA was
enacted. After several delays, CMS indicated this past July that full
implementation of the AUC program was delayed until further notice.
What are the specific reasons for the persistent delays in
implementation? Is CMS considering a new implementation timeline? If
so, what is the new timeline?
CMS has indicated that significant concerns related to improperly
denying claims that may not be subject to the AUC consultation
requirement (e.g., imaging performed in critical access hospitals)
still exist and preclude full implementation.
Is this concern expressed by CMS still valid? Does CMS envision a
solution to this concern?
Would CMS be open to working with Congress and other stakeholders
to identify AUC implementation difficulties, and then amend PAMA to
alleviate those concerns and successfully implement this program?
Answer. The Protecting Access to Medicare Act (PAMA) directed CMS
to establish a program to promote the use of appropriate use criteria
(AUC) for advanced diagnostic imaging services. CMS has taken steps to
implement this program over several years, and codified the AUC program
in our regulations. In Calendar Year 2020, CMS began conducting an
educational and operations testing period for the claims-based
reporting of AUC consultation information. This operations and testing
period has been extended until further notice.
Further, to incentivize the use of qualified clinical decision
support mechanisms (CDSMs) to consult AUC, CMS established in the CY
2018 Updates to the Quality Payment Program; and Quality Payment
Program: Extreme and Uncontrollable Circumstances Policy for the
Transition Year final rule and interim final rule, a high-weighted
improvement activity under the Merit-based Incentive Payment System
(MIPS). This activity can be selected under MIPS by ordering
professionals who consult specified AUC using a qualified CDSM. The
activity was implemented with the performance period that began January
1, 2018.
CMS is continuing to evaluate the AUC program, as well as other
quality and value-based care initiatives that may help with appropriate
utilization of advanced diagnostic imaging services. In previous
rulemaking, CMS has raised operational and administrative issues with
the AUC program and solicited additional information from stakeholders
on mechanisms to ensure that only appropriate claims are subject to AUC
claims processing edits. The identification of claims that are or are
not subject to the Medicare AUC Program must be precise to avoid
inadvertently denying claims that should be paid. CMS would be happy to
work with Congress and provide technical assistance on any potential
amendments related to this program.
______
Submitted by Hon. Marsha Blackburn,
a U.S. Senator From Tennessee
From The New York Times, February 25, 2023
Alone and Exploited, Migrant Children Work Brutal Jobs Across the U.S.
By Hannah Dreier
Arriving in record numbers, they're ending up in dangerous jobs that
violate child labor laws--including in factories that make products for
well-known brands like Cheetos and Fruit of the Loom.
Cristian works a construction job instead of going to school. He is 14.
Carolina packages Cheerios at night in a factory. She is 15.
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Wander starts looking for day-labor jobs before sunrise. He is 13.
______
It was almost midnight in Grand Rapids, MI, but inside the factory
everything was bright. A conveyor belt carried bags of Cheerios past a
cluster of young workers. One was 15-year-old Carolina Yoc, who came to
the United States on her own last year to live with a relative she had
never met.
About every 10 seconds, she stuffed a sealed plastic bag of cereal into
a passing yellow carton. It could be dangerous work, with fast-moving
pulleys and gears that had torn off fingers and ripped open a woman's
scalp.
The factory was full of underage workers like Carolina, who had crossed
the southern border by themselves and were now spending late hours bent
over hazardous machinery, in violation of child labor laws. At nearby
plants, other children were tending giant ovens to make Chewy and
Nature Valley granola bars and packing bags of Lucky Charms and
Cheetos--all of them working for the processing giant Hearthside Food
Solutions, which would ship these products around the country.
``Sometimes I get tired and feel sick,'' Carolina said after a shift in
November. Her stomach often hurt, and she was unsure if that was
because of the lack of sleep, the stress from the incessant roar of the
machines, or the worries she had for herself and her family in
Guatemala. ``But I'm getting used to it.''
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These workers are part of a new economy of exploitation: migrant
children, who have been coming into the United States without their
parents in record numbers, are ending up in some of the most punishing
jobs in the country, a New York Times investigation found. This shadow
work force extends across industries in every state, flouting child
labor laws that have been in place for nearly a century. Twelve-year-
old roofers in Florida and Tennessee. Underage slaughterhouse workers
in Delaware, Mississippi and North Carolina. Children sawing planks of
wood on overnight shifts in South Dakota.
Largely from Central America, the children are driven by economic
desperation that was worsened by the pandemic. This labor force has
been slowly growing for almost a decade, but it has exploded since
2021, while the systems meant to protect children have broken down.
The Times spoke with more than 100 migrant child workers in 20 states
who described jobs that were grinding them into exhaustion, and fears
that they had become trapped in circumstances they never could have
imagined. The Times examination also drew on court and inspection
records and interviews with hundreds of lawyers, social workers,
educators and law enforcement officials.
In town after town, children scrub dishes late at night. They run
milking machines in Vermont and deliver meals in New York City. They
harvest coffee and build lava rock walls around vacation homes in
Hawaii. Girls as young as 13 wash hotel sheets in Virginia.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Oscar Lopez, a ninth grader, works overnight at a sawmill in South
Dakota. On this day, he skipped school to sleep after a 14-hour shift.
Kirsten Luce for The New York Times.
In many parts of the country, middle and high school teachers in
English-language learner programs say it is now common for nearly all
their students to rush off to long shifts after their classes end.
``They should not be working 12-hour days, but it's happening here,''
said Valeria Lindsay, a language arts teacher at Homestead Middle
School near Miami. For the past 3 years, she said, almost every eighth
grader in her English learner program of about 100 students was also
carrying an adult workload.
Migrant child labor benefits both under-the-table operations and global
corporations, The Times found. In Los Angeles, children stitch ``Made
in America'' tags into J. Crew shirts. They bake dinner rolls sold at
Walmart and Target, process milk used in Ben & Jerry's ice cream and
help debone chicken sold at Whole Foods. As recently as the fall,
middle-schoolers made Fruit of the Loom socks in Alabama. In Michigan,
children make auto parts used by Ford and General Motors.
The number of unaccompanied minors entering the United States climbed
to a high of 130,000 last year--three times what it was 5 years
earlier--and this summer is expected to bring another wave.
These are not children who have stolen into the country undetected. The
federal government knows they are in the United States, and the
Department of Health and Human Services is responsible for ensuring
sponsors will support them and protect them from trafficking or
exploitation.
But as more and more children have arrived, the Biden White House has
ramped up demands on staffers to move the children quickly out of
shelters and release them to adults. Caseworkers say they rush through
vetting sponsors.
While H.H.S. checks on all minors by calling them a month after they
begin living with their sponsors, data obtained by The Times showed
that over the last 2 years, the agency could not reach more than 85,000
children. Overall, the agency lost immediate contact with a third of
migrant children.
An H.H.S. spokeswoman said the agency wanted to release children
swiftly, for the sake of their well-being, but had not compromised
safety. ``There are numerous places along the process to continually
ensure that a placement is in the best interest of the child,'' said
the spokeswoman, Kamara Jones.
Far from home, many of these children are under intense pressure to
earn money. They send cash back to their families while often being in
debt to their sponsors for smuggling fees, rent and living expenses.
``It's getting to be a business for some of these sponsors,'' said
Annette Passalacqua, who left her job as a caseworker in Central
Florida last year. Ms. Passalacqua said she saw so many children put to
work, and found law enforcement officials so unwilling to investigate
these cases, that she largely stopped reporting them. Instead, she
settled for explaining to the children that they were entitled to lunch
breaks and overtime.
Sponsors are required to send migrant children to school, and some
students juggle classes and heavy workloads. Other children arrive to
find that they have been misled by their sponsors and will not be
enrolled in school.
The federal government hires child welfare agencies to track some
minors who are deemed to be at high risk. But caseworkers at those
agencies said that H.H.S. regularly ignored obvious signs of labor
exploitation, a characterization the agency disputed.
In interviews with more than 60 caseworkers, most independently
estimated that about two-thirds of all unaccompanied migrant children
ended up working full time.
A representative for Hearthside said the company relied on a staffing
agency to supply some workers for its plants in Grand Rapids, but
conceded that it had not required the agency to verify ages through a
national system that checks Social Security numbers. Unaccompanied
migrant children often obtain false identification to secure work.
``We are immediately implementing additional controls to reinforce all
agencies' strict compliance with our long standing requirement that all
workers must be 18 or over,'' the company said in a statement.
At Union High School in Grand Rapids, Carolina's ninth-grade social
studies teacher, Rick Angstman, has seen the toll that long shifts take
on his students. One, who was working nights at a commercial laundry,
began passing out in class from fatigue and was hospitalized twice, he
said. Unable to stop working, she dropped out of school.
``She disappeared into oblivion,'' Mr. Angstman said. ``It's the new
child labor. You're taking children from another country and putting
them in almost indentured servitude.''
On the Night Shift
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
When Carolina left Guatemala, she had no real understanding of what
she was heading toward, just a sense that she could not stay in her
village any longer. There was not much electricity or water, and after
the pandemic began, not much food.
The only people who seemed to be getting by were the families living
off remittances from relatives in the United States. Carolina lived
lone with her grandmother, whose health began failing. When neighbors
started talking about heading north, she decided to join. She was 14.
``I just kept walking,'' she said.
Carolina reached the U.S. border exhausted, weighing 84 pounds. Agents
sent her to an H.H.S. shelter in Arizona, where a caseworker contacted
her aunt, Marcelina Ramirez. Ms. Ramirez was at first reluctant: She
had already sponsored two other relatives and had three children of her
own. They were living on $600 a week, and she didn't know Carolina.
When Carolina arrived in Grand Rapids last year, Ms. Ramirez told her
she would go to school every morning and suggested that she pick up
evening shifts at Hearthside. She knew Carolina needed to send money
back to her grandmother. She also believed it was good for young people
to work. Child labor is the norm in rural Guatemala, and she herself
had started working around the second grade.
One of the nation's largest contract manufacturers, Hearthside makes
and packages food for companies like Frito-Lay, General Mills and
Quaker Oats. ``It would be hard to find a cookie or cracker aisle in
any leading grocer that does not contain multiple products from
Hearthside production facilities,'' a Grand Rapids-area plant manager
told a trade magazine in 2019.
General Mills, whose brands include Cheerios, Lucky Charms and Nature
Valley, said it recognized ``the seriousness of this situation'' and
was reviewing The Times's findings. PepsiCo, which owns Frito-Lay and
Quaker Oats, declined to comment.
Three people who until last year worked at one of the biggest
employment agencies in Grand Rapids, Forge Industrial Staffing, said
Hearthside supervisors were sometimes made aware that they were getting
young-looking workers whose identities had been flagged as false.
``Hearthside didn't care,'' said Nubia Malacara, a former Forge
employee who said she had also worked at Hearthside as a minor.
In a statement, Hearthside said, ``We do care deeply about this issue
and are concerned about the mischaracterization of Hearthside.'' A
spokesman for Forge said it complied with state and federal laws and
``would never knowingly employ individuals under 18.''
Kevin Tomas said he sought work through Forge after he arrived in Grand
Rapids at age 13 with his 7-year-old brother. At first, he was sent to
a local manufacturer that made auto parts for Ford and General Motors.
But his shift ended at 6:30 in the morning, so he could not stay awake
in school, and he struggled to lift the heavy boxes.
``It's not that we want to be working these jobs. It's that we have to
help our families,'' Kevin said.
By the time he was 15, Kevin had found a job at Hearthside, stacking
50-pound cases of cereal on the same shift as Carolina.
``So Many Red Flags''
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The growth of migrant child labor in the United States over the
past several years is a result of a chain of willful ignorance.
Companies ignore the young faces in their back rooms and on their
factory floors. Schools often decline to report apparent labor
violations, believing it will hurt children more than help. And H.H.S.
behaves as if the migrant children who melt unseen into the country are
doing just fine.
``As the government, we've turned a blind eye to their trafficking,''
said Doug Gilmer, the head of the Birmingham, Ala., office of Homeland
Security Investigations, a federal agency that often becomes involved
with immigration cases.
Mr. Gilmer teared up as he recalled finding 13-year-olds working in
meat plants; 12-year-olds working at suppliers for Hyundai and Kia, as
documented last year by a Reuters investigation; and children who
should have been in middle school working at commercial bakeries.
``We're encountering it here because we're looking for it here,'' Mr.
Gilmer said. ``It's happening everywhere.''
Children have crossed the southern border on their own for decades, and
since 2008, the United States has allowed non-Mexican minors to live
with sponsors while they go through immigration proceedings, which can
take several years. The policy, codified in anti-trafficking
legislation, is intended to prevent harm to children who would
otherwise be turned away and left alone in a Mexican border town.
When Kelsey Keswani first worked as an H.H.S. contractor in Arizona to
connect unaccompanied migrant children with sponsors in 2010, the
adults were almost always the children's parents, who had paid
smugglers to bring them up from Central America, she said.
But around 2014, the number of arriving children began to climb, and
their circumstances were different. In recent years, ``the kids almost
all have a debt to pay off, and they're super stressed about it,'' Ms.
Keswani said.
She began to see more failures in the vetting process. ``There were so
many cases where sponsors had sponsored multiple kids, and it wasn't
getting caught. So many red flags with debt. So many reports of
trafficking.''
Now, just a third of migrant children are going to their parents. A
majority are sent to other relatives, acquaintances or even strangers,
a Times analysis of federal data showed. Nearly half are coming from
Guatemala, where poverty is fueling a wave of migration. Parents know
that they would be turned away at the border or quickly deported, so
they send their children in hopes that remittances will come back.
In the last 2 years alone, more than 250,000 children have entered the
United States by themselves.
The shifting dynamics in Central America helped create a political
crisis early in Mr. Biden's presidency, when children started crossing
the border faster than H.H.S. could process them. With no room left in
shelters, the children stayed in jail-like facilities run by Customs
and Border Protection and, later, in tent cities. The images of
children sleeping on gym mats under foil blankets attracted intense
media attention.
The Biden administration pledged to move children through the shelter
system more quickly. ``We don't want to continue to see a child
languish in our care if there is a responsible sponsor,'' Xavier
Becerra, secretary of health and human services, told Congress in 2021.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
His agency began paring back protections that had been in place
for years, including some background checks and reviews of children's
files, according to memos reviewed by The Times and interviews with
more than a dozen current and former employees.
``Twenty percent of kids have to be released every week or you get
dinged,'' said Ms. Keswani, who stopped working with H.H.S. last month.
Concerns piled up in summer 2021 at the Office of Refugee Resettlement,
the H.H.S. division responsible for unaccompanied migrant children. In
a memo that July, 11 managers said they were worried that labor
trafficking was increasing and complained to their bosses that the
office had become ``one that rewards individuals for making quick
releases, and not one that rewards individuals for preventing unsafe
releases.''
Staff members said in interviews that Mr. Becerra continued to push for
faster results, often asking why they could not discharge children with
machine-like efficiency.
``If Henry Ford had seen this in his plants, he would have never become
famous and rich. This is not the way you do an assembly line,'' Mr.
Becerra said at a staff meeting last summer, according to a recording
obtained by The Times.
The H.H.S. spokeswoman, Ms. Jones, said that Mr. Becerra had urged his
staff to ``step it up.'' ``Like any good leader, he wouldn't hesitate
to do it again--especially when it comes to the well-being and safety
of children,'' she said.
During a call last March, Mr. Becerra told Cindy Huang, the O.R.R.
director, that if she could not increase the number of discharges, he
would find someone who could, according to five people familiar with
the call. She resigned a month later.
He recently made a similar threat to her successor during a meeting
with senior leadership, according to several people who were present.
``It Was All Lies''
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While many migrant children are sent to the United States by their
parents, others are persuaded to come by adults who plan to profit from
their labor.
Nery Cutzal was 13 when he met his sponsor over Facebook Messenger.
Once Nery arrived in Florida, he discovered that he owed more than
$4,000 and had to find his own place to live. His sponsor sent him
threatening text messages and kept a running list of new debts: $140
for filling out H.H.S. paperwork; $240 for clothes from Walmart; $45
for a taco dinner.
``Don't mess with me,'' the sponsor wrote. ``You don't mean anything to
me.''
Nery began working until 3 a.m. most nights at a trendy Mexican
restaurant near Palm Beach to make the payments. ``He said I would be
able to go to school and he would take care of me, but it was all
lies,'' Nery said.
His father, Leonel Cutzal, said the family had become destitute after a
series of bad harvests and had no choice but to send their oldest son
north from Guatemala.
``Even when he shares $50, it's a huge help,'' Mr. Cutzal said.
``Otherwise, there are times we don't eat.'' Mr. Cutzal had not
understood how much Nery would be made to work, he said. ``I think he
passed through some hard moments being up there so young.''
Nery eventually contacted law enforcement, and his sponsor was found
guilty last year of smuggling a child into the United States for
financial gain. That outcome is rare: In the past decade, federal
prosecutors have brought only about 30 cases involving forced labor of
unaccompanied minors, according to a Times review of court databases.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Unlike the foster care system, in which all children get case
management, H.H.S. provides this service to about a third of children
who pass through its care, and usually for just 4 months. Tens of
thousands of other children are sent to their sponsors with little but
the phone number for a national hotline. From there, they are often on
their own: there is no formal follow-up from any federal or local
agencies to ensure that sponsors are not putting children to work
illegally.
In Pennsylvania, one case worker told The Times he went to check on a
child released to a man who had applied to sponsor 20 other minors. The
boy had vanished. In Texas, another case worker said she had
encountered a man who had been targeting poor families in Guatemala,
promising to help them get rich if they sent their children across the
border. He had sponsored 13 children.
``If you've been in this field for any amount of time, you know that
there's what the sponsors agree to, and what they're actually doing,''
said Bernal Cruz Munoz, a caseworker supervisor in Oregon.
Calling the hotline is not a sure way to get support, either. Juanito
Ferrer called for help after he was brought to Manassas, VA, at age 15
by an acquaintance who forced him to paint houses during the day and
guard an apartment complex at night. His sponsor took his paychecks and
watched him on security cameras as he slept on the basement floor.
Juanito said that when he called the hotline in 2019, the person on the
other end just took a report. ``I thought they'd send the police or
someone to check, but they never did that,'' he said. ``I thought they
would come and inspect the house, at least.'' He eventually escaped.
Asked about the hotline, H.H.S. said operators passed reports onto law
enforcement and other local agencies because the agency did not have
the authority to remove children from homes.
The Times analyzed government data to identify places with high
concentrations of children who had been released to people outside
their immediate families--a sign that they might have been expected to
work. In northwest Grand Rapids, for instance, 93 percent of children
have been released to adults who are not their parents.
H.H.S. does not track these clusters, but the trends are so pronounced
that officials sometimes notice hot spots anyway.
Scott Lloyd, who led the resettlement office in the Trump
administration, said he realized in 2018 that the number of
unaccompanied Guatemalan boys being released to sponsors in South
Florida seemed to be growing.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
``I always wondered what was happening there,'' he said.
But his attention was diverted by the chaos around the Trump
administration's child separation policy, and he never looked into it.
The trend he saw has only accelerated: For example, in the past 3
years, more than 200 children have been released to distant relatives
or unrelated adults around Immokalee, FL., an agricultural hub with a
long history of labor exploitation.
In a statement, H.H.S. said it had updated its case management system
to better flag instances when multiple children were being released to
the same person or address.
Many sponsors see themselves as benevolent, doing a friend or neighbor
a favor by agreeing to help a child get out of a government shelter,
even if they do not intend to offer any support. Children often
understand that they will have to work, but do not grasp the
unrelenting grind that awaits them.
``I didn't get how expensive everything was,'' said 13-year-old Jose
Vasquez, who works 12-hour shifts, 6 days a week, at a commercial egg
farm in Michigan and lives with his teenage sister. ``I'd like to go to
school, but then how would I pay rent?''
Occupational Hazards
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One fall morning at Union High School in Grand Rapids, Carolina
listened to Mr. Angstman lecture on the journalist Jacob Riis and the
Progressive Era movement that helped create federal child labor laws.
He explained that the changes were meant to keep young people out of
jobs that could harm their health or safety, and showed the class a
photo of a small boy making cigars.
``Riis reported that members of this family worked 17 hours a day, 7
days a week,'' he told the students. ``The cramped space reeked of
toxic fumes.'' Students seemed unmoved. Some struggled to stay awake.
Teachers at the school estimated that 200 of their immigrant students
were working full time while trying to keep up with their classes. The
greatest share of Mr. Angstman's students worked at one of the four
Hearthside plants in the city.
The company, which has 39 factories in the United States, has been
cited by the Occupational Safety and Health Administration for 34
violations since 2019, including for unsafe conveyor belts at the plant
where Carolina found her job. At least 11 workers suffered amputations
in that time. In 2015, a machine caught the hairnet of an Ohio worker
and ripped off part of her scalp.
The history of accidents ``shows a corporate culture that lacks urgency
to keep workers safe,'' an OSHA official wrote after the most recent
violation for an amputation.
Underage workers in Grand Rapids said that spicy dust from immense
batches of Flamin' Hot Cheetos made their lungs sting, and that moving
heavy pallets of cereal all night made their backs ache. They worried
about their hands getting caught in conveyor belts, which federal law
classifies as so hazardous that no child Carolina's age is permitted to
work with them.
Hearthside said in a statement that it was committed to complying with
laws governing worker protections. ``We strongly dispute the safety
allegations made and are proud of our safety-first culture,'' the
statement read.
Federal law bars minors from a long list of dangerous jobs, including
roofing, meat processing and commercial baking. Except on farms,
children younger than 16 are not supposed to work for more than 3 hours
or after 7 p.m. on school days.
But these jobs--which are grueling and poorly paid, and thus
chronically short-staffed--are exactly where many migrant children are
ending up. Adolescents are twice as likely as adults to be seriously
injured at work, yet recently arrived preteens and teenagers are
running industrial dough mixers, driving massive earthmovers and
burning their hands on hot tar as they lay down roofing shingles, The
Times found.
Unaccompanied minors have had their legs torn off in factories and
their spines shattered on construction sites, but most of these
injuries go uncounted. The Labor Department tracks the deaths of
foreign-born child workers but no longer makes them public. Reviewing
state and federal safety records and public reports, The Times found a
dozen cases of young migrant workers killed since 2017, the last year
the Labor Department reported any.
The deaths include a 14-year-old food delivery worker who was hit by a
car while on his bike at a Brooklyn intersection; a 16-year-old who was
crushed under a 35-ton tractor-scraper outside Atlanta; and a 15-year-
old who fell 50 feet from a roof in Alabama where he was laying down
shingles.
In 2021, Karla Campbell, a Nashville labor lawyer, helped a woman
figure out how to transport the body of her 14-year-old grandson, who
had been killed on a landscaping job, back to his village in Guatemala.
It was the second child labor death she had handled that year.
``I've been working on these cases for 15 years, and the addition of
children is new,'' Ms. Campbell said.
In dairy production, the injury rate is twice the national average
across all industries. Paco Calvo arrived in Middlebury, VT when he was
14 and has been working 12-hour days on dairy farms in the 4 years
since. He said he crushed his hand in an industrial milking machine in
the first months of doing this work.
``Pretty much everyone gets hurt when they first start,'' he said.
Targeting the Middlemen
Charlene Irizarry, the human resources manager at Farm Fresh Foods, an
Alabama meat plant that struggles to retain staff, recently realized
she was interviewing a 12-year-old for a job slicing chicken breasts
into nuggets in a section of the factory kept at 40 degrees.
Ms. Irizarry regularly sees job applicants who use heavy makeup or
medical masks to try to hide their youth, she said.``Sometimes their
legs don't touch the floor.''
Other times, an adult will apply for a job in the morning, and then a
child using the same name will show up for orientation that afternoon.
She and her staff have begun separating other young applicants from the
adults who bring them in, so they will admit their real ages.
Ms. Irizarry said the plant had already been fined for one child labor
violation, and she was trying to avoid another. But she wondered what
the children might face if she turned them away.
``I worry about why they're so desperate for these jobs,'' she said.
In interviews with underage migrant workers, The Times found child
labor in the American supply chains of many major brands and retailers.
Several, including Ford, General Motors, J. Crew and Walmart, as well
as their suppliers, said they took the allegations seriously and would
investigate. Target and Whole Foods did not respond to requests for
comment. Fruit of the Loom said it had ended its contract with the
supplier.
One company, Ben & Jerry's, said it worked with labor groups to ensure
a minimum set of working conditions at its dairy suppliers. Cheryl
Pinto, the company's head of values-led sourcing, said that if migrant
children needed to work full time, it was preferable for them to have
jobs at a well-monitored workplace.
The Labor Department is supposed to find and punish child labor
violations, but inspectors in a dozen states said their understaffed
offices could barely respond to complaints, much less open original
investigations. When the department has responded to tips on migrant
children, it has focused on the outside contractors and staffing
agencies that usually employ them, not the corporations where they
perform the work.
In Worthington, MN, it had long been an open secret that migrant
children released by H.H.S. were cleaning a slaughterhouse run by JBS,
the world's largest meat processor. The town has received more
unaccompanied migrant children per capita than almost anywhere in the
country.
Outside the JBS pork plant last fall, The Times spoke with baby-faced
workers who chased and teased one another as they came off their shifts
in the morning. Many had scratched their assumed names off company
badges to hide evidence that they were working under false identities.
Some said they had suffered chemical burns from the corrosive cleaners
they used.
Not long afterward, labor inspectors responding to a tip found 22
Spanish-speaking children working for the company hired to clean the
JBS plant in Worthington, and dozens more in the same job at meat-
processing plants around the United States.
But the Labor Department can generally only issue fines. The cleaning
company paid a $1.5 million penalty, while JBS said it had been unaware
that children were scouring the Worthington factory each night. JBS
fired the cleaning contractor.
Many of the children who were working there have found new jobs at
other plants, The Times found.
``I still have to pay back my debt, so I still have to work,'' said
Mauricio Ramirez, 17, who has found a meat processing job in the next
town over.
``Not What I Imagined''
It has been a little more than a year since Carolina left Guatemala,
and she has started to make some friends. She and another girl who
works at Hearthside have necklaces that fit together, each strung with
half a heart. When she has time, she posts selfies online decorated
with smiley faces and flowers.
Mostly, though, she keeps to herself. Her teachers do not know many
details about her journey to the border. When the topic came up at
school recently, Carolina began sobbing and would not say why.
After a week of 17-hour days, she sat at home one night with her aunt
and considered her life in the United States. The long nights. The
stress about money. ``I didn't have expectations about what life would
be like here,'' she said, ``but it's not what I imagined.''
She was holding a debit card given to her by a staffing agency, which
paid her Hearthside salary this way so she did not have to cash checks.
Carolina turned it over and over in her palm as her aunt looked on.
``I know you get sad,'' Ms. Ramirez said.
Carolina looked down. She wanted to continue going to school to learn
English, but she woke up most mornings with a clenched stomach and kept
staying home sick. Some of her ninth grade classmates had already
dropped out. The 16-year-old boy she sat next to in math class,
Cristian Lopez, had left school to work overtime at Hearthside.
Cristian lived a few minutes away, in a bare two-room apartment he
shared with his uncle and 12-year-old sister, Jennifer.
His sister did not go to school either, and they had spent the day
bickering in their room. Now night had fallen and they were eating
Froot Loops for dinner. The heat was off, so they wore winter jackets.
In an interview from Guatemala, their mother, Isabel Lopez, cried as
she explained that she had tried to join her children in the United
States last year but was turned back at the border.
Cristian had given his uncle some of the money he earned making Chewy
bars, but his uncle believed it was not enough. He had said he would
like Jennifer to start working at the factory as well, and offered to
take her to apply himself.
Cristian said he had recently called the H.H.S. hotline. He hoped the
government would send someone to check on him and his sister, but he
had not heard back. He did not think he would call again.
https://www.nytimes.com/2023/02/25/us/unaccompanied-migrant-child-
workers-exploitation.html
______
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.
I do want to respond to the question of the debt ceiling
negotiations. I want to make it very clear, the Republicans are asking
for negotiations on the debt ceiling process, to add some fiscal
restraint into the debt ceiling extension. I ask you, Secretary
Becerra, to take back to the President my plea that he engage with us
in negotiations.
I want to make it clear, we are not talking about trying to reduce
benefits in Medicare or Social Security for our seniors. What we are
talking about is reasonable reforms that can help us get to some kind
of fiscal restraint on our spiraling debt. I encourage all of my
colleagues in the Senate, but particularly the President, to engage
with those kinds of negotiations.
I want to start my formal remarks on the positive. You have
testified before and talked to me privately about the fact that
although we have our differences on a lot of different policy areas, we
want to find those areas where we can work together, and we found some
last year.
Late last year, we came together on a package of bipartisan reforms
to produce common-sense solutions, ranging from mental health
improvements to comprehensive telehealth coverage for seniors and
working families. Moreover, we accomplished all of this while reducing
the deficit by billions of dollars.
Fortunately, the administration supports these policies, and I look
forward to partnering with the U.S. Department of Health and Human
Services (HHS), as well as with my colleagues on both sides of the
aisle, to advance additional reforms that improve health-care access,
affordability, and choice for all Americans. That being said, I do have
concerns with the budget the President has put forward.
Unfortunately, many of the proposals in the President's budget run
directly counter to these types of initiatives. I have serious concerns
with the focus on partisan policies that risk harming health-care
access and affordability, for both current and future patients. The
budget's central proposal, for instance, would dramatically expand the
size and scope of the bureaucratic, government-run drug price-setting
program enacted under last year's Inflation Reduction Act (IRA).
Prior to that law's passage, my Republican colleagues and I warned
repeatedly that imposing sweeping price controls would prove disastrous
for patients, biomedical research and development, and domestic
manufacturing jobs. Many of our fears have already come to pass.
We pointed to the risk of higher launch prices and distorted
pricing practices, based on projections validated by the nonpartisan
Congressional Budget Office. And sure enough, The Wall Street Journal
reported in January, and I quote, ``The impact in 2023 may actually be
higher drug prices.'' We also expressed concerns around lifesaving R&D,
as a University of Chicago study estimated the IRA would result in 135
fewer new drug approvals in the next 2 decades. That figure would
inevitably skyrocket under the budget's proposed expansion. Already,
numerous manufacturers have signaled plans to table certain projects in
light of the uncertainty created by the IRA.
In recent months, we have also seen a rash of drug shortages, which
even leading U.S. Food and Drug Administration (FDA) officials have
attributed to pricing dynamics. Doubling down on the IRA's price
controls would exacerbate the law's most harmful consequences.
Americans deserve better and more affordable access to prescription
drugs, and we can find bipartisan, results-oriented solutions this year
to advance that goal. Government price mandates, however, are a step in
the wrong direction.
I also have profound concerns with the budget's bold claims of
averting the Medicare hospital insurance trust fund's looming
insolvency, largely through massive tax hikes and budget gimmicks. This
unbalanced approach does nothing to address Medicare's cost drivers. It
would also punish the small business job creators and entrepreneurs who
drive our economy.
Unfortunately, the budget takes a similarly shortsighted approach
to Medicaid, reviving a number of rejected policies from past
proposals, including hundreds of billions in new spending, tied to
burdensome conditions and efforts to circumvent State leaders.
The Federal Government should focus on supporting States as they
work to return Medicaid to post-pandemic normalcy, rather than imposing
new top-down mandates. Instead of turning to one-size-fits-all
solutions, we should look to proven models for Federal programs, such
as Medicare Advantage. With sky-high patient satisfaction rates,
Medicare Advantage shows that consumer choice and market forces can
produce more benefits and better outcomes.
As we move forward, I encourage your Department, Mr. Secretary, to
focus on our many shared goals, from cost-cutting competition to
sustainable telehealth access, rather than on partisan priorities.
Thank you again for being here today, and thank you, Mr. Chairman.
______
Submitted by Hon. Thom Tillis,
a U.S. Senator From North Carolina
From The Washington Post
Our Law Helps Patients Get New Drugs Sooner
By Birch Bayh and Bob Dole *
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* The writers are, respectively, a former Democratic senator from
Indiana and a former Republican Senator from Kansas.
---------------------------------------------------------------------------
As co-authors of the Bayh-Dole Act of 1980, we must comment on the
March 27 op-ed article by Peter Arno and Michael Davis about this law.
Government alone has never developed the new advances in medicines and
technology that become commercial products. For that, our country
relies on the private sector. The purpose of our act was to spur the
interaction between public and private research so that patients would
receive the benefits of innovative science sooner.
For every $1 spent in government research on a project, at least $10 of
industry development will be needed to bring a product to market.
Moreover, the rare
government-funded inventions that become products are typically five to
seven years away from being commercial products when private industry
gets involved. This is because almost all universities and government
labs are conducting early-stage research.
Bayh-Dole did not intend that government set prices on resulting
products. The law makes no reference to a reasonable price that should
be dictated by the government. This omission was intentional; the
primary purpose of the act was to entice the private sector to seek
public-private research collaboration rather than focusing on its own
proprietary research.
The article also mischaracterized the rights retained by the government
under Bayh-Dole. The ability of the government to revoke a license
granted under the act is not contingent on the pricing of a resulting
product or tied to the profitability of a company that has
commercialized a product that results in part from government-funded
research. The law instructs the government to revoke such licenses only
when the private industry collaborator has not successfully
commercialized the invention as a product.
The law we passed is about encouraging a partnership that spurs
advances to help Americans. We are proud to say it's working.
______
From Endpoints News, November 1, 2022
Updated: Eli Lilly Blames Biden's IRA for Cancer Drug Discontinuation
as the New Pharma Playbook Takes Shape
By Max Gelman, Senior Editor
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\\ https://endpts.com/author/max-gelman/.
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Eli Lilly laid blame Tuesday afternoon on President Joe Biden's
Inflation Reduction Act as the reason it scrapped a $40-million cancer
drug.
As part of its third quarter update earlier Tuesday morning, the Big
Pharma revealed it had removed a Phase I drug licensed from Fosun
Pharma, a BCL2 inhibitor that had been undergoing studies for a variety
of blood cancers. Though the reasoning had been initially unclear, an
Eli Lilly spokesperson told Endpoints News in an email that ``in light
of the Inflation Reduction Act, this program no longer met our
threshold for continued investment.''
Asked to explain how the IRA impacted this specific drug, the
spokesperson highlighted the law's impact on small molecule R&D.
``The IRA changes many dynamics for small molecules in oncology and
when we integrated those changes with this program and its competitive
landscape, the program's future investment no longer met our
threshold,'' the spokesperson told Endpoints in a follow-up email.
The Inflation Reduction Act, which Biden signed into law over the
summer, contains provisions allowing Medicare to negotiate prices for
certain high-cost drugs. Starting in 2026, the HHS Secretary will
select drugs from a list of the highest-selling Medicare Part D and,
later on, Part B medicines for which the agency will be allowed to set
a ``maximum fair price.''
For small molecules, the government can begin negotiating prices after
the drugs have been on the market for at least 9 years. The drugs would
also have to be among the top therapies Medicare pays for. Critics of
the law have said beginning negotiations at the nine-year mark will
hamper innovation, because pharma companies obtain 13 years of market
exclusivity--a threshold which remains in place with the IRA.
Lilly's decision comes a few days after Alnylam noted the IRA in a
press release, tying it to the legislation to a decision ending Phase
III plans for vutrisiran in the rare Stargardt disease. In this
instance, Alnylam emphasized the orphan drug exemption for the IRA's
drug price caps, in which therapies are exempt from Medicare
negotiations if approved for only one designation.
Earlier this year, the FDA approved vutrisiran, branded as Amvuttra, to
treat hereditary transthyretin-mediated (hATTR) amyloidosis. Alnylam
lists the price at $463,500 per patient per year, and the drug pulled
in about $25 million in its first quarter on the market.
The Lilly drug, dubbed LOXO-338, was far from any regulatory decision.
Researchers were testing it as a monotherapy in Phase I studies and it
would have progressed to a combination cohort had safety and efficacy
been confirmed, according to the federal government's clinical trials
database.
Lilly expected to enroll more than 300 patients, as of the trial's most
recent update on October 12.th Started in August 2021, the study was
supposed to observe patients' response rates over the course of two
years and report data in 2024. But with Lilly dropping the program,
it's not clear what will happen to patients who have already taken the
experimental drug.
Lilly licensed LOXO-338 from Fosun Pharma in October 2020, nabbing the
rights to the drug everywhere but China for $40 million. On top of
that, Fosun had been eligible for up to $400 million in milestones and
mid-to-high single-digit royalty payments on any approvals.
Additionally, Lilly abandoned another pipeline program Tuesday, a
PACAP38-
targeting antibody known as LY3451838. According to previous SEC
filings, researchers had been testing the drug in a Phase II study for
chronic pain since November 2020. But in August, Lilly updated the
indication to migraines.
Per the trial database, the Phase II trial was completed this past
September. A press release from Lilly Neuroscience said the study ``did
not meet pre-specified critical success factors.''
With earnings season in full swing, Lilly isn't the only Big Pharma
company to cull programs from its pipeline. Last month, Roche chopped a
Phase II eye disease candidate after a biotech tossed a similar drug
the day before, and Novartis indefinitely postponed plans to submit an
FDA pitch for its PD-1 drug. GSK made a broad retreat from NY-ESO as a
cancer target when it pulled out of two cell therapy 2.0 alliances,
while AbbVie discarded an autoimmune drug, the product of a 10-year
discovery partnership.
______
From Bloomberg, October 27, 2022
Alnylam Halts Work on Eye Drug, Citing New U.S. Law Over Pricing
By Angelica Peebles \1\
---------------------------------------------------------------------------
\1\ https://www.bloomberg.com/authors/AUdOqwkfIrY/angelica-peebles.
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Drugmaker had planned to expand drug's use for eye disease
New drug-price negotiation law cited as disincentive
Alnylam Pharmaceuticals Inc.\2\ said it's stopping work on a treatment
for a rare eye disease because of a new U.S. drug-pricing law with the
potential to limit how much it could charge for the medication in the
future.
---------------------------------------------------------------------------
\2\ https://www.bloomberg.com/quote/
ALNY:US?leadSource=uverify%20wall.
Alnylam will not begin a planned late-stage trial of its drug Amvuttra
for Stargardt disease, which causes blindness, while it examines the
Inflation Reduction Act, the company said Thursday in its third-quarter
earnings statement.\3\ The shares fell 2.7% as of 10:47 a.m. in New
York.
---------------------------------------------------------------------------
\3\ https://www.bloomberg.com/news/terminal/RKEUO0MEWG7T.
Under the act, the U.S. Government will be able to negotiate prices for
a small subset of drugs in the Medicare program for seniors. The law
targets drugs that Medicare spends the most money on and have been on
the market for years, and drug companies like Alnylam have argued that
---------------------------------------------------------------------------
it discourages investment in new medicines.
Amvuttra is already approved to treat a rare disease called
transthyretin-mediated amyloidosis, and Alnylam was exploring Stargardt
disease as a second indication. The company charges $463,500 per
patient a year for the drug and in the third quarter, its first full
quarter on the market, the company reported $25 million in revenue from
it.
Alnylam isn't moving forward with adding the second indication because
the act exempts drugs with one rare-disease use from price
negotiations. The list of drugs subject to negotiations is limited to
the 50 Medicare spends the most money on by 2029, and it's not clear
whether Amvuttra would fall into that category.
Alnylam is ``still digesting the legislation,'' said Yvonne
Greenstreet, chief executive officer of the Cambridge, Massachusetts-
based company, said Thursday on a call discussing the earnings results.
Management has considerable concerns about the legislation, she said.
Greenstreet said Alnylam remains interested in Stargardt disease, which
is estimated \4\ to affect fewer than 200,000 people in the U.S. and
causes progressive vision loss. She said the company is still trying to
figure out the best path forward.
---------------------------------------------------------------------------
\4\ https://rarediseases.info.nih.gov/diseases/181/stargardt-
disease.
______
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.
The President's budget comes down to a simple proposition: helping
working families and the middle class get ahead and reducing the
deficit are not mutually exclusive.
When it comes to health care, that means protecting Medicare for
the next generation by asking the wealthy to pay their fair share in
taxes; strengthening Medicare's negotiating power for the cost of
prescription drugs; and investing in priorities like mental health
care, home-based care, and the health-care workforce.
That's a sharp contrast to the Republican approach to the Federal
budget since the beginning of this year, which amounts to demanding
secret negotiations on unspecified cuts to Federal programs while
holding hostage the full faith and credit of the United States
Government.
Budget Committee Chair Whitehouse and I asked the nonpartisan
Congressional Budget Office to run the numbers, and it's clear that
Republican promises to spare certain parts of the budget like Social
Security and Medicare just don't add up. Sparing essential lifelines
for seniors in addition to Republican priorities like extending the
Trump tax law means essentially zeroing out everything else in the
Federal budget.
I want to take a moment to address reports that some members are
considering proposals that cut earned benefits in Medicare or Social
Security for those who are not yet at retirement age. Let me be very
clear: as long as I'm chairman of the Finance Committee, I will fight
any effort to engage in intergenerational warfare. There are plenty of
ideas to improve the financial health of these programs that do not
include forfeiting the earned benefits of current workers.
Now I'm going to take a minute to talk about what cuts like these
mean in practical terms, starting with Medicaid. Contrary to popular
belief, Medicaid acts as the Nation's backstop for nursing home care,
not Medicare. That means when your parents are in their 80s or 90s and
require nursing home care, Medicaid is there to help cover the cost
once they've spent down their hard-earned savings over the course of
their retirement.
If Republicans go after Medicaid the way they did in 2017, by
cutting Federal support to State Medicaid programs and giving States
free reign to pare back benefits, that guaranteed backstop of nursing
home care in old age is ripped away. That means a return to times from
distant memory before the social safety net was created, when older
Americans who ran out of savings and couldn't count on a family member
for help were consigned to poor farms or almshouses.
Colleagues, none of us wants America to return to that time. So
let's look for ways to work together to take on the big health
challenges of the day, rather than pursuing reckless cuts that imperil
American seniors.
I want to briefly tick through some important priorities in the
President's HHS budget.
First, on prescription drugs, the President's budget has several
bold proposals to build on the Inflation Reduction Act that will hold
big pharma accountable for years of high prices, while lowering costs
for seniors. That includes speeding up Medicare negotiation and
increasing the number of drugs subject to negotiation each year. I
support this approach, especially as the Centers for Medicare and
Medicaid Services (CMS) continues to steadily implement the laws that
are already on the books.
Just last week, the Biden administration announced that the anti-
price-gouging law written in this committee on a bipartisan basis in
2019 will lower coinsurance payments for 27 drugs in Medicare Part B.
Part B pays for prescription drugs to treat diseases like cancer and
rheumatoid arthritis administered in the doctor's office. That includes
Humira, which is Exhibit A for why drug pricing reforms were needed in
the first place. Important steps like these--coinsurance reductions,
free vaccines, and the insulin cost cap in Medicare--are just the
beginning of the big league impact this law will have on Americans'
health costs.
Next, mental health care. Last Congress, this committee wrote black
letter law to move the country towards a reality where all Americans
can get quality mental health care when and where they need it, and I
thank Senator Crapo for making sure it was a bipartisan effort
throughout. I'm proud that this committee included a number of
important policies in bipartisan bills, like improved mental health
care in schools, funding for community behavioral health centers--a
longstanding priority for Senator Stabenow--coverage for therapists in
Medicare, and new GME slots for psychiatrists. Despite that important
work last year, every member of this committee knows there is more to
be done. I intend to work with Ranking Member Crapo to enact the
remaining policies that members of this committee put so much sweat
equity into.
When it comes to mental health parity, Congress passed a landmark
law in 2008 based on the proposition that mental health and physical
health should be treated equally. That's not happening today. Fifteen
years after the law was written, insurance companies are still finding
ways to drag their feet. So the challenge for this committee is to stop
the foot-dragging under current law, and develop fresh approaches to
give Americans what they thought they were getting in 2008. The
President's budget takes important steps in that direction, and I'm
proud to be working with Senator Bennet to put mental health care on a
better footing.
I'm also pleased to see the President's budget take a big step when
it comes to postpartum coverage for new mothers in Medicaid. At the end
of last year, Congress came together on a bipartisan basis to create an
option for every State to cover postpartum care for new mothers for 12
months. The President's budget takes the next step to make that
coverage available across the entire country. That's critically
important at the time when maternal mortality is rising, particularly
for Black women.
Before I wrap up, I want to talk about one more critically
important priority--long-term care. Right now, millions of seniors and
Americans with disabilities are falling through the cracks, as recently
reported in The Washington Post. It's high time to develop smart
policies that provide several long-term care options to families to get
the care that's best for their loved ones. One option is home and
community-based care, which the President's budget proposes to expand
in Medicaid. For too many of our fellow Americans who count on Medicaid
for long-term care, it's not possible to receive that type of care with
the current laws on the books. Senator Casey has been a champion of
this effort on the Finance Committee, and I'm proud to call myself his
partner. It's long past time to expand this coverage under Medicaid.
I'm pleased to see so many smart investments in this budget in
high-priority policies that will improve health care for Americans with
coverage under Medicare, Medicaid, and ACA marketplaces.
Thank you for joining the committee this morning, Secretary
Becerra. There's a lot to discuss today, so I look forward to speaking
with you in the Q&A.
______
Communications
----------
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 2024 budget
request.
I have put out previous comments on orphan drugs, examining lessons
learned from the pandemic that need to be noted, mental health
hospitalization, getting to single-payer and establishing a Medicare
Part E for Senior Medicaid and other long term care in the attachments.
These comments will restate my upcoming testimony to the Labor, HHS and
Education Appropriations Subcommittee and the House Budget Committee. I
have not pulled any punches.
From LHHSE:
Developing the Public Option needs to be funded in this budget.
Particularly, it should explore the impacts on coverage and cost of
automatically enrolling individuals who are denied coverage under pre-
existing condition rules. Such rules must be revoked as the price of
passing the bill. Such a trade-off is necessary for enactment of such a
proposal on a bipartisan basis. Healthcare reform should only be done
in this way. Among our other proposals is to fund healthcare spending
through an employer paid subtraction value added tax. This would allow
for the repeal of the ACA-SM surtax on higher-income individuals
enacted as part of the Affordable Care Act.
From the Budget Committee Comments (PB proposals are in boldface):
Extend ACA premium support permanently, extend low cost care in states
that have not expanded Medicaid
ACA subsidies are too low and are funded by taxing the wrong people
(investors). Families in the Silver Plan still have problems meeting
copays and paying premiums. The funding is also unfortunate. Rather
than expanding Medicaid, replace it for the non-elderly with the Public
Option proposed in 2009. The public option should also be extended to
individuals who are denied coverage under pre-existing condition rules.
Such rules must be revoked as the price of passing the bill. Such a
trade-off is necessary for enactment of such a proposal on a bipartisan
basis.
Extends Medicare Solvency: Strengthen Medicare by increasing NIIT
(ACA-SM) and limiting pass through income reforms
As above, taxes to support Medicare should be broad based, funded
either by an employer paid subtraction VAT or a border adjustable goods
and services tax (credit invoice VAT). This would allow for the repeal
of the ACA-SM surtax on higher income individuals enacted as part of
the Affordable Care Act. Tax increases on higher-income individuals
should be dedicated toward fully funding net interest, eventually
reducing the national debt, funding veterans' health care and overseas
military and ocean deployments.
State governments were 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 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.
The way to fully fund healthcare is through an employer-paid
subtraction value-added tax.
From Tax Reform Attachment: Subtraction Value-Added Taxes
Subtraction Value-Added Tax (S-VAT). Corporate income taxes and
collection of business and farm income taxes will be replaced by this
tax, which is an employer paid Net Business Receipts Tax. 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.
As above, S-VAT surtaxes are collected on all income distributed over
$75,000, with a beginning rate of 6.25%. replace income tax levies
collected on the first 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.
The President has punted on reforming Social Security. This is a
mistake--although Chairman Smith and the Majority will not like this
proposal--probably because it would work and take the topic off of the
table.
Individual payroll taxes. A floor of $20,000 would be instituted for
paying these taxes, with a ceiling of $75,000. This lower ceiling
reduces the amount of benefits received in retirement for higher-income
individuals. The logic of the $20,000 floor reflects full time work at
a $10 per hour minimum wage offered by the Republican caucus in
response to proposals for a $15 wage. Any increase to the minimum wage
must fully cover tipped workers. The White House/Senate Majority/House
Minority needs to take the deal. Doing so in relation to a floor on
contributions makes adopting the minimum wage germane in the Senate for
purposes of Reconciliation. The rate would be set at 6.25%.
Employer payroll taxes. Unless taxes are diverted to a personal
retirement account holding voting and preferred stock in the employer,
the employer levy would be replaced by a goods and receipts tax of
6.25%. Every worker who meets a minimum hour threshold would be
credited for having paid into the system, regardless of wage level. All
employees would be credited on an equal dollar basis, rather than as a
match to their individual payroll tax. The tax rate would be adjusted
to assure adequacy of benefits for all program beneficiaries.
Appropriations Subcommittees
Labor, Education, Housing and Related Agencies
Add Housing and Urban Development and Veterans Affairs Housing
functions to reinforce synergies between housing, education and
workforce development.
Transfer out Health and Human Services to decrease the size of the
LHHSE Appropriation package.
Health and Human Services and Veterans Affairs
Create synergies between human services and veterans' health and other
DVA functions.
Closing
We have serious concerns with the way President Biden is paying for the
future of Medicare and extending Obamacare. Please share these with the
Secretary and request a response.
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 2023
Orphan Drugs
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 16, 2022, 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.
Pandemic Lessons
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.
Mental Health Hospitalization
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.
Attachment Two--HHS Budget FY 2022
Single Payer
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 protection 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.
Medicare Part E
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.
______
Chronic Care Policy Alliance
1001 K St., 6th Floor
Sacramento, CA 95814
(916) 444-1985
www.chroniccarealliance.org
Re: Full Committee Hearing: ``The President's Fiscal Year 2024 Health
and Human Services Budget''
Dear Chairman Wyden and Ranking Member Crapo:
On behalf of patients with chronic conditions, the Chronic Care Policy
Alliance urges the Finance Committee to utilize hearings on the 2024
Health and Human Services Budget as an opportunity to ensure
accountability and oversight as that department implements the health
policies included in the 2022 Inflation Reduction Act (IRA).
Additionally, we recommend that legislators prevent further changes to
the new Medicare Drug Price Negotiation Program, including those
proposed by the Biden Administration in the budget for fiscal year
2024, until the IRA has been fully implemented and the impact of these
policy changes are known and understood.
The health policies in the IRA took great strides to lower patient
costs and included many beneficial policies that will provide immediate
relief to patients including out-of-pocket caps, capping the costs of
insulin, and eliminating cost sharing for vaccines. However, the long-
term impact of other provisions of the law, including the Medicare Drug
Price Negotiation Program, remains unknown and could impede the
development of new treatments and limit patients' ability to access new
therapies in years to come.
We were joined by 36 organizations in sending the below letter to
Congress and the Centers for Medicare and Medicaid Services (CMS)
further explaining these concerns and urging that CMS ensure patient
advocates have ample opportunity to weigh-in throughout and after IRA
implementation to limit any negative impact on patients.
Further, given the uncertainty around the Medicare Drug Price
Negotiation Program and other provisions of the IRA, we would urge that
Congress reject any proposals to accelerate the scope of the
negotiation program. The Biden Administration's proposed budget
included proposal to substantially increase the number of drugs on
which CMS can negotiate starting in 2026, and making drugs subject to
negotiation much sooner. According to press reports, this proposal
could double the number of drugs negotiated each year and make drugs
subject to negotiation after only 5 years after FDA approval instead of
the current 9-13 year time frame.
This expansion of an untested policy could lead to disastrous results
for patients by significantly limiting access to current and future
therapies. The impact could also significantly hinder research for
patients with complex or rare diseases that require intricate treatment
regimes.
We appreciate the Finance Committee's ongoing work and oversight to
ensure that patients are protected as these new policies are
implemented and look forward to staying in close touch throughout the
implementation process.
Sincerely,
Liz Helms
Founder/Director
_______________________________________________________________________
In a letter to Congress and the Centers for Medicare & Medicaid
Services (CMS), the Chronic Care Policy Alliance (CCPA) was joined by
36 organizations urging Congress and the Administration to ensure that
patient advocates have a seat at the table throughout the
implementation of the Inflation Reduction Act's health policies. CCPA
and its partners want to protect patient interests and avoid any
unintended consequences by asking for patient input in the planning
phase before implementation. Read the full letter:
Dear Congress:
As patient representatives, we advocate on behalf of patient interests
and interpret how certain policies will positively or negatively affect
them. Patients know firsthand the benefits of a strong health care
system that provides access to new and groundbreaking treatments. In
recent years, we have seen great strides in the treatment of ALS,
cancer and Alzheimer's disease that have increased life span, slowed
the ravage of disease and improved the quality of lives.
Last year, Congress passed significant policies within the Inflation
Reduction Act (IRA) focused specifically on patient costs. We were
especially pleased by the improvements to Medicare Part D that included
adding an out-of-pocket cap, establishing a $35 limit on monthly
insulin costs, and eliminating cost sharing for vaccines. These
policies will provide immediate relief to patients. Thank you.
However, other policies around prescription drug prices faced
significant debate during the legislative process. Policymakers must
keep in mind the unknown long-term impacts on the development of new
treatments--especially those for complex and rare diseases--and
patients' ability to access those new therapies.
Now it is time for the real work as the Administration begins the
lengthy process of implementing IRA's policies. We urge Congress to
continue oversight throughout the implementation process and insist
that patient voices are heard.
The Medicare Drug Price Negotiation Program contained in the law seeks
to establish negotiated rates, or the Maximum Fair Price (MFP), for
medications. While focused on reducing drug costs, the unintended
negative consequences for drug coverage, formulary priority, access and
further research and development could harm patients. For example, as
new prices are determined, payors may favor products on their
formularies that have a negotiated price. This could ultimately make
other medications more difficult to access as payors encourage use of
these negotiated price medications and discourage others. Payors
already utilize cost saving measures that negatively impact patients
such as restrictive formularies, step therapy and strict prior
authorizations. Patients need access to the correct treatments, or they
will suffer. The addition of products with artificially lowered prices
is likely to create yet another restrictive process for patients.
We urge Congress to ensure that regulators at CMS create specific
opportunities for patient advocates to participate in the regulatory
process.
Our specific recommendations include:
Host regional roundtables to solicit feedback from patients. We
strongly recommend that CMS create a structure similar to that used to
implement the Affordable Care Act (ACA) and utilize the CMS regional
staff to hold patient-centered roundtable discussions throughout the
country to ensure that patients have the opportunity to share their
experiences and insights directly with CMS, regardless of their
physical location. Providing regional opportunities is particularly
important in the patient community where resources may make
participation at the federal level more of a challenge than in their
state and local communities.
Release draft guidance, solicit written comments. We are pleased
that CMS has announced that it will issue draft guidance that seeks
public input on key provisions of the MFP program. We hope that the
draft guidance includes and seeks feedback on the process, including
the methodology CMS uses to determine the MFP. Soliciting written
comments from the public is critical.
Develop patient-centered criteria. CMS should also develop, with
significant input from patients, patient-centered criteria that must be
adhered to as CMS implements the drug pricing provisions. This will
ensure patient perspectives are heard and patient needs are
prioritized. The ACA required that the Center for Medicare and Medicaid
Innovation develop similar criteria.
Meaningfully engage patients in determining the MFP for each
drug. Patient advocates can offer both substantial and critical
perspectives as CMS considers what a price should be for a specific
drug. CMS should create a process through which it will consistently
and meaningfully engage with patients determining each drug's price,
and ensure they have a say in the outcome.
Study the impact of the drug pricing provisions on patients. CMS
should study the impact that negotiation has on patients prior to
negotiation, focusing on issues related to access to current and future
therapies. For example, CMS should study the impact of the drug pricing
provisions on Medicare Part D coverage, including formulary placement
and utilization management.
Should you have any questions or comments, please contact Liz Helms,
Founding Director, CCPA at [email protected]. Thank you for
your time and attention to these critical issues.
Sincerely,
Chronic Care Policy Alliance (CCPA)
Alliance for Aging Research; ALLvanza; American Behcet's Disease
Association (ABDA); American Cancer Society Cancer Action Network--
Nevada; Applied Pharmacy Solutions; Autoimmune Association; Axis
Advocacy; Black, Gifted & Whole Foundation; Cancer Support Community;
Chronic Disease Coalition; Coalition of Wisconsin Aging and Health
Groups; Colorado Gerontological Society; GO2 for Lung Cancer; Healthy
Men Inc.; Hereditary Neuropathy Foundation; HIV + Hepatitis Policy
Institute; ICAN, International Cancer Advocacy Network; International
Foundation for AiArthritis; Lazarex Cancer Foundation; Let's Talk About
Change; Looms For Lupus; Men's Health Network; MLD Foundation; National
Association of Nutrition and Aging Services Programs (NANASP); National
Hispanic Medical Association; National Patient Advocate Foundation;
National Puerto Rican Chamber of Commerce; Neuropathy Action Foundation
(NAF); Nevada Chronic Care Collaborative; Partnership for Innovation
and Empowerment; Partnership to Fight Chronic Disease; Patients Rising
Now; RetireSafe; Southern Christian Leadership Global Policy Initiative
(SCL-GPI); Support for People with Oral and Head and Neck Cancer, Inc.
(SPOHNC); The National Puerto Rican Chamber of Commerce
______
Digital Therapeutics Alliance
https://dtxalliance.org/
April 5, 2023
U.S. Senate
Committee on Finance
Hon. Ron Wyden
Chairman
Hon. Mike Crapo
Ranking Member
219 Dirksen Senate Office Building
Washington, DC 20510
Dear Chairman Wyden and Ranking Member Crapo:
On behalf of the Digital Therapeutics Alliance (DTA), we want to take
this opportunity to thank you and the members of the Senate Committee
on Finance for convening a committee hearing on Wednesday, March 22,
2023 on ``The President's Fiscal Year 2024 Health and Human Services
Budget.'' During the hearing the committee focused on various aspects
of President Biden's HHS budget.
We write to the committee today to voice our support for key aspects of
the President FY 2024 budget,\1\ specifically a legislative proposal to
establish Medicare coverage of evidence-based digital applications and
platforms that facilitate the delivery of behavioral health services,
especially for beneficiaries who live in rural or health professional
shortage areas.
---------------------------------------------------------------------------
\1\ https://www.hhs.gov/sites/default/files/fy-2024-budget-in-
brief.pdf.
Digital therapeutics (DTx), a relatively new category of medicine
that--as HHS requests, ``enables Medicare coverage of evidence-based
digital applications and platforms that facilitate the delivery of
mental health services''--deliver therapeutic interventions directly to
patients using scientifically developed, clinically evaluated software
---------------------------------------------------------------------------
to treat, manage, and prevent diseases and disorders.
We therefore respectfully ask the Department of Health and Human
Services to respond to Chairman Wyden's previously submitted questions
for the record on whether CMS can currently reimburse for DTx products
under existing national or local coverage determination processes,
potential or existing criteria for DTx product reimbursement, and
necessary steps to create a new benefit category.
DTx products are subject to rigorous patient-centered core principles
and are used independently, alongside medications, or in tandem with
clinician-delivered therapy. They differ from pure lifestyle, wellness,
adherence, diagnostic, and telehealth products, and are distinct from
the over 350,000 digital health apps available online.
Digital therapeutics' benefits, however, are currently available in the
United States only to patients covered by certain private payors and
select Medicaid plans, and are not available to patients (and their
clinicians) who receive insurance coverage through Medicare. Without a
dedicated Medicare benefit category for digital therapeutics, as
proposed through the Access to Prescription Digital Therapeutics Act
(S. 723 and H.R. 1458), this healthcare inequity will continue to grow,
while also limiting the scalability of DTx access to patients covered
by other commercial and state coverage plans.
We again thank the committee for holding this important hearing and for
considering the important issues raised during the hearing and by the
Digital Therapeutics industry. Should you have any further questions or
issues you would like to discuss, we would be delighted to discuss them
further with you.
Sincerely,
Megan Coder, PharmD, MBA Sara Elalamy
Chief Policy Officer Director of U.S Government Affairs
______
United Network for Organ Sharing (UNOS)
700 North 4th Street
Richmond, VA 23219
tel: 804-782-4800
fax: 804-782-4816
https://unos.org/
U.S. Senate
Committee on Finance
The President's Fiscal Year 2024 Health and Human Services Budget
Wednesday, March 22, 2023
UNOS supports Health Resources and Services Administration's (HRSA)
plan to introduce additional reforms into the nation's organ donation
and transplantation system. We also stand united with HRSA in our
shared goal to get as many donor organs as possible to patients in need
while increasing accountability, transparency and oversight.
We welcome a competitive and open bidding process for the next Organ
Procurement and Transplantation Network (OPTN) contract to advance our
efforts to save as many lives as possible, as equitably as possible. We
believe we have the experience and expertise required to best serve the
nation's patients and to help implement HRSA's proposed initiatives.
Numerous components of HRSA's plan also align with our new action
agenda, which is a list of specific proposals we outlined earlier this
year aimed at driving improvement across the system.
We are committed to working with HRSA, U.S. Department of Heath and
Human Services (HHS), Congress and others who care about this system so
deeply to assist in carrying out these reforms and to do our part to
improve how we serve America's organ donors, transplant patients and
their families.
Dr. Maureen McBride
Interim UNOS CEO
______
[all]