[Senate Hearing 118-769]
[From the U.S. Government Publishing Office]
S. Hrg. 118-769
THE PRESIDENT'S FISCAL YEAR 2025
HEALTH AND HUMAN SERVICES BUDGET
=======================================================================
HEARING
before the
COMMITTEE ON FINANCE
UNITED STATES SENATE
ONE HUNDRED EIGHTEENTH CONGRESS
SECOND SESSION
__________
MARCH 14, 2024
__________
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Finance
______
U.S. GOVERNMENT PUBLISHING OFFICE
62-795--PDF WASHINGTON : 2026
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
----------
OPENING STATEMENTS
Page
Wyden, Hon. Ron, a U.S. Senator from Oregon, chairman, Committee
on Finance..................................................... 1
Crapo, Hon. Mike, a U.S. Senator from Idaho...................... 3
ADMINISTRATION WITNESS
Becerra, Hon. Xavier, Secretary, Department of Health and Human
Services, Washington, DC....................................... 5
ALPHABETICAL LISTING AND APPENDIX MATERIAL
Becerra, Hon. Xavier:
Testimony.................................................... 5
Prepared statement........................................... 53
Responses to questions from committee members................ 59
Blackburn, Hon. Marsha:
Submissions for the record................................... 173
Crapo, Hon. Mike:
Opening statement............................................ 3
Prepared statement........................................... 208
Wyden, Hon. Ron:
Opening statement............................................ 1
Prepared statement........................................... 209
Communications
Center for Fiscal Equity......................................... 211
Commissioned Officers Association of the U.S. Public Health
Service........................................................ 215
NumbersUSA....................................................... 217
Reserve Organization of America.................................. 220
Samluk, Jesse P., Ph.D........................................... 225
Transparency-Rx, American Pharmacy Cooperative, Inc., and the
ERISA Industry Committee (ERIC)................................ 226
(III)
THE PRESIDENT'S FISCAL YEAR 2025
HEALTH AND HUMAN SERVICES BUDGET
----------
THURSDAY, MARCH 14, 2024
U.S. Senate,
Committee on Finance,
Washington, DC.
The hearing was convened, pursuant to notice, at 10:06
a.m., in Room SD-215, Dirksen Senate Office Building, Hon. Ron
Wyden (chairman of the committee) presiding.
Present: Senators Stabenow, Cantwell, Menendez, Carper,
Cardin, Brown, Bennet, Casey, Whitehouse, Hassan, Cortez Masto,
Warren, Crapo, Grassley, Cornyn, Cassidy, Lankford, Young,
Barrasso, Johnson, Tillis, and Blackburn.
Also present: Democratic staff: Shawn Bishop, Chief Health
Advisor; Kripa Sreepada, Senior Health Advisor; Joshua
Sheinkman, Staff Director; and Tiffany Smith, Deputy Staff
Director and Chief Counsel. Republican staff: Kellie McConnell,
Health Policy Director; Gregg Richard, Staff Director; and
Charlotte Rock, Senior Health Policy Advisor.
OPENING STATEMENT OF HON. RON WYDEN, A U.S. SENATOR FROM
OREGON, CHAIRMAN, COMMITTEE ON FINANCE
The Chairman. The Finance Committee will come to order.
Today we meet to discuss the year ahead for health care in
America. Thank you, Secretary Becerra, for joining us.
I am going to start off, colleagues, with a little bit of
history. Topic 1: drug prices. In July 2020, Donald Trump said,
and I quote: ``Since the day I took office, I have made
reducing drug prices one of my highest priorities.'' For 4
straight years, Donald Trump complained about high drug prices,
did lots of finger-pointing at others about the problem, and
repeatedly talked about how he was the best friend seniors who
depend on Medicare could have. What was actually accomplished
over his 4 years? Exactly nothing.
Fast forward to the Biden administration. From the time Joe
Biden took office, President Biden made it clear that he was
committed to lowering drug prices and health-care costs for
families.
I remember him having a conversation with me shortly after
his election, and he said the Finance Committee is the place
where things happen, and everybody has been talking about doing
something about drug prices forever. Now it's time to get
something done, and to actually help seniors--not just talk
about it, because there has been plenty of talk, but actually
get results that provide real pocketbook relief to seniors and
consumers.
Two years later, President Biden--because Senator Stabenow
and many colleagues who are on this side of the aisle worked
very hard to get results to lower prices on medicine--President
Biden signed the Inflation Reduction Act into law.
For the first time, under the law, Democrats and President
Biden gave Medicare the authority to negotiate better drug
prices. Understand what that means. It means that seniors beat
big pharma. Big pharma's holy grail, what they cared about more
than anything, is prohibiting negotiation for a better deal on
medicine.
Look at what they are doing right now, going to court
trying to stop any negotiation. But we have it written into law
that there is going to be negotiation, and on top of it, most
Americans have access to free vaccines. Insulin costs for
seniors were capped at $35 a month. And as we said--Senator
Stabenow and I talk about it all the time--when the government
leads on these issues, particularly the showpiece of American
health care, Medicare, almost always the private sector copies
it.
And so, we have seen some real progress in the private
sector as well--not as much. We want everybody in America to
get that pricing relief, but we are making real progress. We
also created price-gouging penalties for the first time, to
hold big pharma accountable for high drug costs. Those are
already benefiting patients and taxpayers.
We have plenty more to do. For example, it is essential
that finally, after all this debate, we get pharmacy benefit
management reforms across the finish line and that Congress
finish this crucial change that is going to help all these
wonderful people in their white coats--because they are here to
keep the small pharmacies going--and to lower drug costs for
patients and protect community pharmacies.
So that is the difference, folks, on the first issue, drug
prices, between Donald Trump and President Biden.
Topic 2: health insurance. In March 2019, Donald Trump
tweeted, ``The Republican Party will become the party of health
care.'' With the help of Senate Republicans, his number one
health-care goal stated again and again, number one goal,
repeal the Affordable Care Act. Just get rid of the whole
thing. On that one he failed, fortunately, as well.
Under President Biden's leadership, the Democrats boosted
tax credits for health insurance, saving millions of Americans
an average of $800 per year on their coverage and expanding
access to care. So, when you look at President Biden's health-
care budget for the upcoming year, what you see is a clear
focus, which is to build on the progress that the Biden
administration has made.
So, with all these health challenges in mind, the next
question is, what do Donald Trump and the Republicans have
planned when they talk about health care? The American people
are wondering, because not once during the ACA repeal and
replace crusades, not once did we see an actual replacement.
Seven years after the effort to repeal the ACA crashed and
burned, nothing has changed. Donald Trump still says, ``Let's
get rid of it.'' He still lacks a plan to take care of all the
people whose health-care coverage his doing that would actually
rip away. And now apparently, he is even talking about gutting
Americans' hard-earned Social Security and Medicare benefits.
No plan for keeping seniors out of poverty and illness either.
So that is the difference, folks, between what Senate
Democrats and President Biden are talking about, and what
Donald Trump is talking about. The Republican health-care plan
is, shred the programs that exist today that countless
Americans rely on, and just pretend, just pretend everything is
going to be fine.
So, on these issues, I think it is clear that there is a
gap between President Biden and Senate Democrats and Donald
Trump, with respect to health care. The gap between those Trump
promises and Biden action on health care, the difference on the
actual record between the two, is as deep as Crater Lake.
Democrats made promises to the American people, and we got
results; we delivered.
I am going to wrap up by saying there is another issue
today that is pending that is very important for kids and
health care, and that is to get our bipartisan tax deal with
Congressman Jason Smith passed in the Senate. It would help 16
million kids and immediately lift 400,000 kids out of poverty.
Now, you do not have to take my word for this. Here is what the
president of the American Academy of Pediatrics had to say
about this. By the way, in case anybody is interested, he is
from Oregon, Dr. Ben Hoffman.
He is a doctor at Oregon's very own Oregon Health Sciences
Center, and I guess his night job is president of the Academy
of Pediatrics. He has said, and I quote here: ``There's an
inextricable link between poverty and child health.'' An
inextricable link, folks, between poverty and child health.
What we are trying to do--it got 357 votes in the House of
Representatives--is help those 16 million kids be healthier,
and 400,000 of them would get out of poverty right away. So, we
want everybody to know this morning we are all in in terms of
getting it done. We want to pass that bill--the Child Tax
Credits and the help for companies with their research and
development--before the April 15th filing deadline.
So, hearing from the American Academy of Pediatrics, as we
wrap up this discussion, as far as I am concerned is about as
good as it gets. But we are still going to have some more very
good input today from Secretary Becerra about how President
Biden is going to continue to lower costs and improve care for
more families. But first we will hear from 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
before I begin my formal remarks, I will say there is one thing
you and I agree on. That is, we have to control drug prices,
and you already referenced that.
You see a number of folks here in the audience in white
coats. Those are pharmacists, and we met on the grass out in
front of the Capitol today, Senator Wyden and I did, with
hundreds and hundreds of them to talk about one of the most
important things we can do, which we need to do right now,
which is to get the PBM legislation, which passed this
committee 26 to 0, on the books, so that we can start one of
the most significant things that can be done to help control
drug prices.
So I want to focus on that. We do have our disagreements
still on what we consider to be a price-control program and the
impact of it. But we have places where we have agreement, and I
am hopeful that we can make progress on that right away.
Back to my formal remarks. Thank you, Mr. Chairman, and
thank you, Secretary Becerra, for being here today. Over the
course of the past year, the Finance Committee has taken
bipartisan action to tackle a range of health-care challenges,
leveraging collaboration and consensus to advance common-sense
solutions for seniors and working families.
Our pharmacy benefit manager reforms, which I have already
referenced, would modernize Medicare's prescription drug
benefits, driving down costs at the pharmacy counter and
netting billions in savings for taxpayers. Moreover, the
committee's mental health proposals would build on previous
efforts to shore up patient access to critical services,
especially in rural communities.
These policies received nearly unanimous support from
across the dais, all through regular order. Your department and
its subagencies, Mr. Secretary, have offered essential
technical assistance throughout these processes, and that
support has ensured alignment between our legislation and its
intended goals, and I thank you for that. As we move forward,
further action on these overdue patient-focused proposals must
become an urgent priority, not just for our committee but also
for the administration. We have a responsibility to patients,
community pharmacies, and front-line health-care providers to
deliver on these commitments, regardless of policy differences
on other fronts.
The President's budget request, unfortunately, falls
severely short of that aim. On prescription drug affordability,
for instance, the document makes virtually no mention of the
robust bipartisan, bicameral efforts to reform PBM practices,
instead opting to double down on a price-control policy that
polarizes members in both chambers. Bipartisan bills in the
Senate and the House would address unintended consequences
spurred by the Inflation Reduction Act's pricing provisions,
particularly for patients with rare diseases who will likely
see fewer treatment options under that law.
Rather than embrace these avenues for viable reform,
however, the budget seeks to expand the program's scope, with
no attempt at improved transparency, certainty, or mitigation.
Further, the President's budget request affirms an overreaching
mandate that would force more nursing homes to close their
doors, and result in less access to home and community-based
services for Medicaid beneficiaries. This document highlights
divisions and misses vital opportunities for productive
patient-driven partnerships with Congress. We will continue
engaging with your department on a host of health-care hurdles
that demand policymakers' attention. You have rightly raised
concerns, for instance, around the ongoing surge in medication
shortages, including for lifesaving therapies.
The chairman and I recently released a white paper
outlining potential solutions to prevent and mitigate this
crisis, and we look forward to working with HHS and CMS to
develop legislation designed to achieve these goals. We also
stand ready to partner on proposals aligned with the
President's Cancer Moonshot, including by ensuring that seniors
can access innovations like multicancer early detection
screening. Those tests can be invaluable for a Cancer Moonshot.
Earlier this Congress, I joined Senator Bennet in reintroducing
our bill to grant Medicare coverage for these technologies, and
bipartisan majorities in both chambers--bipartisan majorities
in both chambers--have joined as cosponsors for this
legislation.
More broadly, while the administration erred in rescinding
regulations aimed at expediting access to medical
breakthroughs, your department could take a range of steps to
restore patients' trust in reliable coverage for medical
devices, including by expanding and enhancing the proposed
pathway that CMS published last year.
Before closing, let me emphasize the importance of timely
communication with respect to the cyberattack on Change
Healthcare. While your department has recently taken important
steps to issue guidance and flexibility to insurers, providers,
and contractors to mitigate the effects of this hack, the over-
2-week delay resulted in unavoidable uncertainty. Already
financially vulnerable rural hospitals and providers with
little to no cash reserves required immediate action by the
administration to ensure payrolls could be met and services
could be continued without interruption.
In the coming days and weeks, HHS should continue to update
members and stakeholders on efforts to limit further
disruption. We have an obligation to build on longstanding
legacies of bipartisanship and bolster the clinician workforce,
drive value-based care, improve broken payment systems, and
ensure long-term access to telehealth.
With these joint goals in mind, thank you again for being
here, Mr. Secretary, and thank you, Mr. Chairman.
[The prepared statement of Senator Crapo appears in the
appendix.]
The Chairman. Thank you, Senator Crapo. As Senator Crapo
noted, and I think I talked about this with Senator Cornyn--I
cannot see him down there--getting a 26-to-nothing vote from
the Senate Finance Committee on a major piece of legislation
involving enormous sums of money is just about impossible
around here.
It is hard to get a 26- or 27-to-nothing vote for ordering
soda pop. So I thank my colleagues for their work on that.
Secretary Becerra?
STATEMENT OF HON. XAVIER BECERRA, SECRETARY, DEPARTMENT OF
HEALTH AND HUMAN SERVICES, WASHINGTON, DC
Secretary Becerra. Chairman Wyden, Ranking Member Crapo,
and members of the committee, thank you for the invitation.
When President Biden took office in January 2021, COVID was
ravaging our families and our economy, and Americans were dying
at the rate of two to three 9/11s every day. I will repeat
that: every day, we were losing Americans at the rate of two to
three 9/11s every day.
In January 2021, the number of Americans with health
insurance was, like our jobs and the economy, down and on the
canvas. Prescription drug prices were skyrocketing, with
patients and their pocketbooks at the mercy of big pharma and
its profits.
Today, 3 years later, nearly 700 million shots of COVID
vaccine have gone into the arms of Americans, and we can now
manage COVID like the flu. Today, more than 300 million
Americans, a record number, can go to the doctor or hospital
and not go bankrupt, because they have their own health
insurance. More than 21 million of those Americans can count on
the Affordable Care Act marketplace for their insurance,
another record. Today, while big pharma is still big, the
President's new prescription drug law has brought down the
price of insulin to $35 per month for Americans on Medicare,
and as we speak, we are negotiating with drug companies to
lower the prices of even more prescription drugs, even as they
sue us to stop us.
The President's budget doubles down on the investments that
made the comeback of our jobs, our economy, and our health
possible. It lays out a vision for a Nation that invests in its
most vulnerable, fosters innovation, and protects every
American's access to the care she needs. This budget does not
just strengthen Medicare; it strengthens it beyond our
lifetime.
This budget continues our shift from a health system that
treats illness to one that sustains wellness. All told, the
Fiscal Year 2025 budget proposes $130.7 billion in
discretionary and $1.7 trillion in mandatory funding to advance
our mission and invest in key priorities. Let me share some of
the highlights. The budget provides Medicaid-like coverage to
low-income individuals in the outlier States that have not
expanded Medicaid under the Affordable Care Act. When that
happens, another 1.5 million Americans will have health-care
coverage and the peace of mind that comes with it.
This budget builds on the largest investment in behavioral
health in a generation. It bolsters a 988 suicide and crisis
lifeline. It gives young people support at home and school.
That means boosting our behavioral health workforce with 12,000
new psychiatrists, psychologists, clinical social workers,
marriage and family therapists, counselors, and peer-support
specialists.
Across HHS, the budget tackles the maternal health crisis
by improving access to pre- and postnatal care, supporting
emergency care services, and expanding maternal care in rural
and underserved communities. We are making child care more
affordable for working families, and more available where
families live and work.
This budget would provide increased wages for early
childhood education workers, and it would fund more than
750,000 slots for children in Head Start. It funds universal
preschool for our Nation's 4 million 4-year-old children, and
will eventually include our 3-year-olds as well.
Our budget grows and strengthens our cybersecurity
initiatives to ensure patient safety and privacy, and to keep
our hospitals and providers, especially smaller ones and those
in rural communities, running and secure. Finally, this
administration has made tremendous strides in preparedness
capabilities since the pandemic, and we keep building.
This budget invests in countermeasures to combat
antimicrobial-resistant drugs, to expand our monitoring of
supply chains, and to integrate 200 data sources across
Federal, State, and local governments, to improve information
sharing.
We cannot reduce the health and well-being of Americans to
a line on a budget spreadsheet, but we can transform the
numbers on that balance sheet into investments and services
that sustain health and promote wellness for all Americans.
President Biden has presented a forward-leaning budget. I look
forward to taking your questions.
[The prepared statement of Secretary Becerra appears in the
appendix.]
The Chairman. Thank you, Mr. Secretary.
Let me start with the lower prescription drug costs for
seniors issue. Again, I went through some of what former
President Donald Trump said. He said pharma companies were
getting away with murder. He said that would change under his
presidency, that he would create a fair and competitive bidding
process, and prices would come way, way down. And, colleagues,
these are exact quotes from Donald Trump.
And I am quite certain, Mr. Secretary, when you came in,
none of that had been actually accomplished. I described that
conversation I had with President Biden after the election,
where he said he was going a very different route: Medicare
drug price negotiation, stop the price gouging if they raise
the prices over inflation, cap out-of-pocket costs for seniors.
He took on big pharma and won; not just talk, delivery.
So, Mr. Secretary, one that I was very involved in,
stopping this price gouging--is it correct that some seniors
are now saving $618 per dose on a drug that they get in their
doctor's office?
Secretary Becerra. Senator, that is correct, and it is
going to grow even more in terms of savings because, as we move
through the years, many of the provisions that you all helped
pass are kicking in. So today, a senior will not have to worry
about these enormous costs if they are on a drug medication,
because there is a limit now on what they will pay, their
capped spending.
So, it might be about $3,500 this year, but next year the
limit on expenditures out of pocket for a senior, $2,000.
The Chairman. Now for the first time, in addition to the
price-gouging penalty and the out-of-pocket costs and these
priorities that I mentioned, for the first time Medicare is
negotiating drug prices. And on this one, as I say, we beat
pharma and took away their holy grail, which is trying to
prohibit negotiation.
I would like to hear more about the 10 high-cost drugs that
you are negotiating. How many people with Medicare take the
drugs that you are negotiating this year? I do not believe I
have seen an aggregate number on this. I think the American
people would like to know how many people with Medicare take
these drugs that you are fighting to lower the prices on. What
is the number?
Secretary Becerra. So, Mr. Chairman, let me work down. So
we know there are 65, 66 million Americans who receive health
care through Medicare. Not all of them take the 10 drugs that
were negotiated, but for many they are lifesaving, and they
need them.
Suffice it to say that in 2022, the costs of just these 10
drugs, just for Medicare, the 66 million--not the 330 million
Americans, just the 66 million Americans on Medicare--the cost
of those 10 drugs in 2022 alone was $46 billion; out of pocket
from those very seniors who were using those drugs, about $3.5
billion.
And so, it is big money for just those 10 drugs, and the
next year, when we get to negotiate for 15 more drugs, we will
get to save Americans even more.
The Chairman. And what is the ballpark number, Mr.
Secretary, in terms of how many people with Medicare are taking
these drugs?
Secretary Becerra. I could not give you the specifics on
all the 10. I do not have that before me, or for any one of the
particular ones. But they are very well-known drugs, and for
seniors they treat principally issues like cancer, heart
disease, and kidney failure. It is the kind of chronic disease
that we know quite a bit about. I could try to get you specific
numbers----
The Chairman. Why don't you get us that for the record? But
you are saying that the amount of money involved in this area--
I thought I heard you say $46 billion.
Secretary Becerra. Forty-six billion dollars in 1 year for
10 drugs.
The Chairman. Okay.
Secretary Becerra. Just for Medicare.
The Chairman. In 1 year; okay.
Let's talk about this cybersecurity breach, which is, you
know, so serious. I am of the view that it also relates to the
fact that these facilities are getting bigger and bigger, and
then I think they become really a systemic kind of risk. We
have to get on top of this.
For a long time, these private companies have been allowed
to set their own standards, and it does not seem very
surprising that neither UnitedHealth Group nor Federal agencies
were prepared for the attack on Change Healthcare and its
fallout.
My view is that the health-care sector is a prime target
for criminals and foreign adversaries, and as I say, as these
companies have become so large, it is creating a systemic
cybersecurity risk. Today, there are no Federal mandatory
technical cybersecurity standards for the health-care industry,
even though people have been talking about this for ages, I
mean, something like 2 decades.
I want to make it clear that has got to change now. Now, I
understand that in your budget, you are going to increase
penalties for compliance violations and make the first actual
concrete proposal to require real mandatory cybersecurity
standards for hospitals.
Mandatory standards are a great first step, but we have got
to do more, and the next step has got to be the fines and
accountability for negligent CEOs, for example, which will
enable HHS to better protect patients and our national
security. Will you work with me, Mr. Secretary, to start
holding these executives who are not doing their job in line
with the kind of safety standards the American people have a
right to expect on cyber? Will you work with me so we start
holding the negligent CEOs accountable?
Secretary Becerra. Mr. Chairman, we look forward to working
with you and every member on this dais on these issues.
The Chairman. All right.
Senator Crapo?
Senator Crapo. Thank you, Mr. Chairman.
Mr. Secretary, last year this committee, as we have said,
voted nearly unanimously to pass two bipartisan PBM reform
bills, which we have already described here, so I will not do
that again. Together, these provisions would generate billions
in taxpayer savings, in addition to bringing down costs for
seniors with chronic conditions.
These bipartisan bills reflect, by far, the most
comprehensive and consensus-driven solution to a range of
challenges raised by members in both chambers across the
political spectrum. That said, this legislation and this issue
is absent, as I see it, in the President's budget, sending a
troubling signal to the patients and community pharmacies and
front-line health-care providers across the country.
Secretary Becerra, what concrete steps does the
administration plan to take to support our efforts to get this
legislation moved expeditiously and put into law?
Secretary Becerra. Senator, we are absolutely prepared to
work with you. I have said this for about over a year, both in
this chamber and the other chamber, that we are absolutely
ready to work with you on PBM reform. We want to find that
there will be more transparency in the way these PBMs operate,
and certainly I think we all agree there is no reason to have
middlemen in the health-care system if they are not going to
provide health care.
And so, we very much look forward to working with you on
this, and we appreciate that there is bipartisan support.
Senator Crapo. Well, and I did say in my opening statement
that you have given very good technical support as we developed
this legislation. I am asking now that the President step up
and use the bully pulpit to get this legislation moved in this
Congress. Please, I would ask you to please take that request
back to him.
Secretary Becerra. And you are probably aware, Senator,
that we just did an event at the White House on this very
issue, to really highlight it for the American people.
Senator Crapo. Good news.
When the IRA passed nearly 2 years ago, Mr. Secretary, your
department praised the law unconditionally. As implementation
proceeds, however, American seniors have experienced the
consequences of the law. A growing number of clinical trials
for medical breakthroughs have been canceled, particularly for
rare disease drugs. Part D plans exclude more and more
medications from coverage, and subject others to prior
authorization and step therapy, delaying critically needed
care. Copays continue to skyrocket, often tied to inflated
sticker prices, which exclude any rebates or discounts. In
short, the system's flaws have gotten worse, not better.
Secretary Becerra, can you commit to working with Congress
on a bipartisan basis to remedy these issues and improve the
Part D program, rather than prioritizing IRA expansion, which
remains both a partisan and unrealistic endeavor?
Secretary Becerra. Senator, we absolutely look forward to
working with you on a bipartisan basis. I will say that the
President is very clear and is doubling down on the IRA, and
making it work even more effectively. But we absolutely look
forward to working with you on a bipartisan basis.
Senator Crapo. Well, that is disappointing. It has been
disappointing to hear, but we received the President's message,
and I am just asking you to help us try to find some bipartisan
solutions to move forward.
On telehealth, telehealth coverage has proven critical for
seniors and working families across Idaho and the rest of the
country. Unfortunately, without additional action, Medicare
beneficiaries and Americans with high-deductible health plans
risk losing access to telehealth services overnight at the end
of this year.
Patients and front-line providers currently face profound
uncertainty as we move closer to this coverage cliff. Secretary
Becerra, what actions do your department and its subagencies
plan to take in order to avert this unacceptable outcome, as
well as to reassure millions of Americans who rely on
telehealth for core coverage every day?
Secretary Becerra. Senator, we continue to work with you
and your colleagues here and in the House of Representatives on
the extensions of some of those flexibilities. As you know,
statutorily we are constrained in being able to extend some of
those flexibilities on telehealth. We need your support. We are
working also with our State and local partners because, as you
know, many of those issues involved State rules and laws.
So, for example, a practitioner practicing out beyond State
lines through telehealth, that has to be done with the
concurrence of States before a doctor in your State can
practice in my State. So we are working with them as well, so
we can extend these telehealth flexibilities.
Senator Crapo. Well, we understand that part of that ball
is in our court. It really helps when we have a mutual activity
to try to get those kinds of resolutions to the finish line. So
thank you for your attention to that.
Secretary Becerra. Yes.
Senator Crapo. With that, thank you, Mr. Chairman.
The Chairman. Thank you, Senator Crapo.
Senator Stabenow?
Senator Stabenow. Well, thank you so much, Mr. Chairman and
Ranking Member. And, Secretary Becerra, welcome. It is always
good to see you. I appreciate all the work you are doing, you
and your department, and I really appreciate the critical
investments to expand health-care access and affordability for
communities, for families across the Nation, that is proposed
in the President's budget. This really does build on the
investments and the work that we have done as Democrats with
the President in the last 3 years.
You know, I do want to say, Mr. Chairman, I want to correct
one thing you were talking about----
The Chairman. Please.
Senator Stabenow [continuing]. That former President Trump
did not do anything on prescription drugs. What I would say is,
he did not do anything for people on prescription drugs. But
President Trump and Republican colleagues did give a 40-percent
tax cut to big pharma in their tax law.
The Chairman. You got it.
Senator Stabenow. That 40-percent tax cut did not translate
to a 40-percent reduction in prices for the seniors in Michigan
or for anybody on medication in Michigan. So we have been
focused, working with the President and with you, on cutting
prescription drug costs for Americans who have been paying the
highest prices in the world, even though we have major
investments we do as taxpayers to support the development of
these new drugs.
So the bills that we have been working on together have
delivered lower costs as we know, improved access, and
transformed the way we provide behavioral health care in this
country, which is so important, and as you know, is something I
care deeply about.
We have over 21 million people now receiving health care
through the Affordable Care Act. That is a record, right? Over
21 million people signed up for insurance--very, very
affordable insurance--and that is including 418,000
Michiganders, many getting a good policy for $10 a month, $20 a
month. I mean, it has transformed families' lives to be able to
have that health care.
The health-care premiums have gone down hundreds of dollars
for 271,000 Michigan residents who are using the Affordable
Care Act. And of course, the $35 cap on insulin is lowering
out-of-pocket costs for seniors in Michigan and across the
country, not counting the inflation caps on cancer drugs that
are used in doctor's offices or hospitals; not counting the cap
this year on out-of-pocket costs or next year, when it goes to
a permanent $2,000.
And so, there is a lot of--you know, it is a big deal. It
is a big deal what we have been doing. So I want to just ask
you a question and speak to what I like to call ``health care
above the neck,'' because we need to make sure health care
above the neck is the same as health care below the neck for
people.
We have made historic investments in mental health,
behavioral health, on a bipartisan basis. It has been really
terrific to see that happen, and I appreciate partnering with
you and with the President to lower costs and create more
access, as you have talked about. But particularly in this
budget, the President included significant investments in the
future of community care, which is Certified Community
Behavioral Health Clinics, which we are funding through the
health-care system, not through grants that stop and start.
And as you know, this is something that keeps people out of
the hospital, out of the jail unnecessarily, people off the
streets who have been homeless, and gets them the care that
they need. So we expanded CCBHCs nationwide through the
Bipartisan Safer Communities Act. States are stepping up to
participate. We have more States this Spring that will be
coming into the full program.
I know that the budget not only supports CCBHCs' expansion,
but makes it permanent, and I also want to give a shout-out to
Senator Cornyn. Thank you for being my partner in moving
forward the definitions on CCBHCs, to make sure they are
permanently a part of Medicare and Medicaid, so this program is
permanent. So, thank you for partnering on that.
Can you elaborate on your plans to make this a permanent
foundation for how we provide behavioral health care in
communities across our country?
Secretary Becerra. Senator, first to you and Senator
Cornyn, thank you for putting in place something that has
proven to be a great success, and that now everyone wants to
do, because mental health conditions do not surface only
between 9 to 5. They occur at any hour, any part of the day,
and you have to be ready.
And what you all did in making Certified Community
Behavioral Health Clinics available, critical care centers
available 24-7, was a God-saving measure for so many people.
So, we are going to try to encourage other States to buy in,
because the more we have these centers, the quicker we cut the
cost of care for taxpayers because, at the end of the day, many
of these folks end up using the emergency room to get the care
that they need.
And so, what you have done is--by establishing these
centers that are specific for them, for mental health
conditions, it gives them a chance to see professionals that
could treat them right away. And so we are going to build on
that. The President's budget commits to that, and thank God you
all came together on a bipartisan basis to address what 9 in 10
Americans say is a growing mental health crisis in this
country.
Senator Stabenow. Thank you.
Thank you, Mr. Chairman.
The Chairman. I thank my colleague.
Next is Senator Grassley.
Senator Grassley. I am going to bring up a problem with
your department, the very same problem I recently had with the
EPA. So, it is not just your department that this might be a
problem with, but last month, I wrote oversight letters to 15
HHS contractors and grantees. Those 15 organizations receive
some of the largest contract awards for the care and placement
of unaccompanied children. My oversight work is based on new
information that shows many children may have been placed in a
very dangerous situation. I want to know what these contractors
are doing to ensure children's safety.
In response to my 15 letters, your department sent an email
to contractors and grantees on February 28th, that I want to
quote: ``Kindly direct Senator Grassley's office to HHS's
Office of Assistant Secretary for Legislation for this
request.''
My staff have been told by contractors that they are ready
to respond to me, but HHS instruction has so far caused them
not to. Do you accept the premise that recipients of
congressionally appropriated taxpayers' money must respond
directly to congressional oversight requests, and I hope you
can answer that positively that they should?
If you would agree with me, when would you direct your
staff to clarify to recipients of my letter that they must
respond to Congress? Now, we had EPA saying these letters I
sent to other groups spending taxpayers' money, that they could
respond directly to me. So, can you say that for your
department?
Secretary Becerra. Senator, as a former member, I too
wanted to be able to conduct oversight when I was in the House
of Representatives, and so, absolutely. These contractors,
these various entities, Americans, have every opportunity and
right to respond directly to you. We offered to provide them
with some guidance if they wished to have it. They were under
no obligation to get it. But you are absolutely within your
rights, and they are as well, to be in communication.
Senator Grassley. Okay. So as a follow-up, just let me be
very clear. These folks that I wrote to have received together
billions of dollars of taxpayers' money. When I and my
colleagues send them requests for information, they have an
obligation to respond, and this administration's interference,
which evidently we are not going to have anymore, at least for
a while, has been obstructive.
Then another question: if HHS receives a law enforcement
request for information relevant to a child's trafficking
investigation, does the HHS provide that information to law
enforcement without requiring a subpoena?
Secretary Becerra. We work on an ongoing basis with law
enforcement throughout the country, because again, we care for,
we have custody, temporary custody for minors. And so we
continue to work with law enforcement throughout the country.
We follow the rules. In some cases, we are dealing with very
private, sensitive, confidential information, and so we make
sure we follow the rules so we do not violate any individuals'
privacy. At the same time, we are fulfilling our obligations to
respond to law enforcement.
Senator Grassley. Are you saying in some cases you can
reply directly to law enforcement without a subpoena, and then
are you saying in other cases you might need a subpoena?
Secretary Becerra. We try to make sure that we are
complying with the law when it comes to providing information.
Some information is more confidential than other pieces of
information. So we make sure that we are not violating any
privacy rights, any protections in providing information,
whether it is to law enforcement or any other entity.
Senator Grassley. This would have to be my last question,
and then I will submit questions in writing for the record. At
last year's budget hearing, you and I discussed supporting
rural health care, including the need for CMS to fully utilize
the Rural Community Hospital Demonstration program.
Right now, CMS is only using 25 of its statutory 30
hospital spots for this program. You told me last year that HHS
would, quote-unquote, ``do more to support rural hospitals in
need.'' Following our discussion, I wrote the CMS
Administrator. Then at my request, the CMMI Director met with
two rural hospitals interested in joining the program, but that
is where the progress stalled.
CMS explained that in order to fill the open spot, it would
require 12 months of work, and too many hospitals would be
interested. If CMS has the tools to help one rural hospital and
it is not, you should be doing something about it.
I realize you might not know about every program at HHS,
but why doesn't your department want to help five rural
hospitals through this program? It is budget-neutral, and
Congress has reauthorized it three times since 2003.
Secretary Becerra. I know time has expired, but, Mr.
Chairman, may I respond?
The Chairman. Just briefly.
Secretary Becerra. Briefly, Senator, let us follow up on
this. But what I will tell you is, if you take a look at the
President's budget--and we can get back to you with a number of
the projects that we have undertaken in rural America--we are
doing a great deal, especially with many facilities that are on
the verge of closing, and that would be even worse for many
parts of rural America.
But let me follow through with you on your particular
concerns, because we have quite a bit to talk about when it
comes to our work in health care for rural America, and this
budget, as you will see, makes major investments in rural
America.
The Chairman. We are going to have to move on.
Senator Menendez is next.
Senator Menendez. Mr. Secretary, for years communities
across the country have struggled to fill major provider
workforce gaps, a growing crisis exacerbated by the pandemic.
Based on my legislation, Congress authorized the creation of
1,000 new Medicare-
funded graduate medical education slots in the Consolidated
Appropriations Act of 2021, and outlined specific, specific
criteria for distributing these slots. However, CMS has
repeatedly included additional criteria not specified in the
law, which unfairly disadvantages many States, including New
Jersey. Since enactment, there have been two rounds of
distribution for these slots, meaning we are 40 percent of the
way through the program, and New Jersey continues to be
completely shut out.
It has been years, and we still do not have an answer as to
how we get positions to teaching hospitals in my State. The law
clearly specifies that ``the Secretary shall,'' not may,
``shall distribute residency positions to each of four
specified categories of providers.'' So, what can you commit to
doing to help ensure that States are no longer unfairly shut
out of the program, in contravention to the way the law is
written?
Secretary Becerra. Senator, I appreciate the question,
because I know that this has been one you have worked on for
quite some time, and our team has been trying to be responsive
to your staff as well. As you know, in New Jersey, like
California, the circumstances sometimes make it difficult for
some regions to be able to qualify for some of the resources,
and in this case, GME slots.
We are more than willing to work with your team, but the
resolution is not so simple because, as you try to resolve the
issues that affect States like New Jersey or California, you
create other issues for other States.
Senator Menendez. Well, let me interrupt you, because it is
not so difficult. The law is clear. It is CMS, the kingdom of
CMS, that has decided to add additional criteria that Congress
did not stipulate. I am sure when you were a member in the
House Ways and Means Committee, you really appreciated it when
Federal agencies changed the law that you helped pass, and
enacted it in a way that was not your intention. That is
exactly what is happening here; exactly what is happening here.
I think you have the power to fulfill the law, as it says ``the
Secretary shall'' distribute residency provisions in accordance
with the law. This is not happening in accordance with the law,
and so this suggestion that the Department is trying to be
cooperative and helpful falls far short on me. I hope we can
find a better way forward.
Last month, your agency's Inspector General issued a
concerning report, finding that over a few months' period, 16
percent of unaccompanied migrant children files lacked any kind
of sponsor background checks. It also found that in nearly 20
percent of cases where unaccompanied minors were released to
sponsors pending a background check, there was no documentation
confirming those checks were ever completed. Given the alarming
problem of unaccompanied migrant children being released into
situations where they are ruthlessly exploited for their labor,
this is a glaring blind spot that needs to be addressed.
Extrapolating from the report, we are talking about
potentially thousands of migrant children who are sent to
unvetted sponsors. As the report concludes, ``The failure to
complete background checks increased children's risk of being
released to unsafe sponsors.'' What specific actions has your
agency taken in response to the finding of the Inspector
General's report, and how is your agency working to ensure that
expeditiously finding sponsors for unaccompanied minor children
does not come at the cost of their safety and well-being?
Secretary Becerra. Senator, I can assure you that most of
the recommendations that were made by the Inspector General for
incidents--you are referring to incidents that occurred back in
Spring of 2021, a 2- or 3-month period. I can assure you that
what was being observed by the Inspector General back then is
not the case today. If you recall, at that point we had an
infrastructure that had been virtually dismantled. We had to
stand it up, and at that point we were dealing with an influx
of children.
Senator Menendez. So today we would find none of this is
what you are telling me?
Secretary Becerra. You would find that we are now doing all
of the background checks. We are doing a thorough assessment of
anyone who is seeking to become a vetted sponsor.
Senator Menendez. All right. I look forward to seeing that
as a reality.
Finally, a recent Supreme Court decision has upended vital
protections for ESRD patients, protections that Congress passed
40 years ago through the Medicare Secondary Payer Act. I am
proud to partner with Senator Cassidy on a bill to amend that
act and protect patients living with ESRD from discrimination
by private health insurance plans. But unfortunately, we are
not able to get your agency to work with us to fix this
problem. Will you commit to CMS working with my staff, and
Senator Cassidy's staff, to have the appropriate information we
need to address this problem?
Secretary Becerra. I absolutely commit to make sure that
our staff is working with your and Senator Cassidy's staff, and
I know that we have been engaged with some of the folks on this
particular issue.
Senator Menendez. Thank you, Mr. Chairman.
The Chairman. Senator Cornyn?
Senator Cornyn. Thank you, Mr. Chairman.
Mr. Secretary, in August your department recommended the
reclassification of marijuana to a Schedule III for the Drug
Enforcement Administration. Previous administrations had used a
five-
factor test to determine what the scheduling of a drug should
be, but this administration, your office, has created a new
two-factor test to determine currently accepted medical use.
What is the reason for the change?
Secretary Becerra. Senator, thank you for the question, and
as you will see from the report that has now been made public,
there has been a lot of science that has been collected over
the years on cannabis. We have far more information now. As you
know, throughout the country many States have moved much
farther than the Federal Government has. Even in places like
Texas, you see where action has been taken on cannabis. What we
are doing is simply reflecting what the science is showing.
Senator Cornyn. You have compared it to heroin in terms of
its potential for abuse. Why didn't you compare other types of
drugs that are scheduled by your office?
Secretary Becerra. I am going to try not to speak directly
for the FDA, because the FDA did this assessment analysis
independently from HHS. They are the agency that has been
tasked with that job, with their scientists, and I will not try
to speak for them.
But what I will tell you is that the rigorous work that was
done to come to these conclusions was based on the science and
the evidence they had before them.
Senator Cornyn. Did they do additional research into
adolescent brain development or mental health consequences, or
the impact on pregnant women?
Secretary Becerra. I am sure they took into consideration
all the information out there on both the effects and the
evidence that there is on cannabis use.
Senator Cornyn. You are saying that for a fact?
Secretary Becerra. Senator, as I was saying, I do not want
to try to speak for the FDA and its scientists, because I did
not do the actual assessment. But I am pretty----
Senator Cornyn. But you announced the recommendation. I
assume you would take into account impact on adolescent brain
development, on mental health consequences, or pregnant women?
Secretary Becerra. As I said, I am sure that the FDA would
have taken into account all of the different circumstances
involved. I did not make the recommendation. It was made by
FDA.
Senator Cornyn. I want to follow up on some of the
questions that Senator Menendez and Senator Grassley asked.
Your department is responsible for the administration of the
Office of Refugee Resettlement, correct?
Secretary Becerra. That is correct.
Senator Cornyn. And that means that any unaccompanied
children who come to our border are basically transferred to
your care by the Border Patrol, correct?
Secretary Becerra. That is correct.
Senator Cornyn. And you identify a sponsor for them in the
interior of the United States, correct?
Secretary Becerra. That is our obligation, yes.
Senator Cornyn. Yes. And there have been about 400,000 of
these unaccompanied children who have come to the United States
during President Biden's term of office. Can you tell us where
they are now?
Secretary Becerra. We can give you information on the
vetting process and----
Senator Cornyn. No; I asked you, do you know where they are
now?
Secretary Becerra. As I said to you, we can tell you who
the vetted sponsors were that received----
Senator Cornyn. That is not what I asked you. I know that
you have interviewed sponsors to some extent, although not
adequately. I agree with Senator Menendez. But do you have any
responsibility for their welfare as you sit here today?
Secretary Becerra. While they are in our custody, we have
jurisdiction to provide them with----
Senator Cornyn. I am talking about now that they are in
custody of your vetted sponsors.
Secretary Becerra. Senator, you and your colleagues did not
give us jurisdiction to provide the oversight of these children
once they left our care.
Senator Cornyn. So that is not your responsibility? Is that
what you are saying?
Secretary Becerra. We do not have jurisdiction. We cannot
spend money on things we do not have jurisdiction over.
Senator Cornyn. So you do not know whether they are being
trafficked for sex, whether they are being forced into
dangerous jobs of child labor? You do not know whether they are
going to school? You do not know whether they are getting the
health care they need? You simply do not know, correct?
Secretary Becerra. Well, while they are in our care, we
know all those things and they do not happen.
Senator Cornyn. Well, they are no longer in your care once
you transfer them to the sponsors, right?
Secretary Becerra. As I said, Senator, the statutes that
you all passed do not give us the authority to monitor these
kids once they are out of our custody.
Senator Cornyn. So, whose responsibility is it to look
after the welfare of these children?
Secretary Becerra. My understanding is the statutes that
you all passed left that open for the communities where they
enter.
Senator Cornyn. Say that again?
Secretary Becerra. My understanding is the statutes that
you all enacted that said that our jurisdiction over these kids
ends once we have delivered them to a vetted sponsor, is that
the communities where they reside will now be in charge of
providing for their services.
Senator Cornyn. So, as a result of the broken border
policies of the Biden administration, these kids have been
placed with sponsors. You do not know where they are, you do
not know what is happening to them. You do not think that is
your responsibility, and you frankly do not care?
Secretary Becerra. No, that is not accurate, and these laws
preceded President Biden taking office. This system has been
broken--as you know and I know--for more than 40 years, or
close to 40 years. You and I have been in Congress for quite
some time. I started in Congress back in 1993----
Senator Cornyn. Well, you have a job to do right now. You
have about a $1.8-trillion budget, and you have the
responsibility for taking care of these children, and you
simply hand them off to sponsors, to homes where you do not
know the conditions they are living in.
Secretary Becerra. That is not true.
Senator Cornyn. You do not know where they are going to
school, whether they are being sold for sex or forced into
labor. You do not know, and you do not think it is your
responsibility, correct?
Secretary Becerra. No, I would dispute pretty much what you
just said, Senator.
The Chairman. The time of the gentleman has expired. I am
going to go to Senator Lankford in just a minute. But we just
got some information from the Department of Health and Human
Services here at the committee. The number of Medicare
beneficiaries who are going to save money because of Medicare
negotiation is 9 million. That would be 1 out of 7 Medicare
beneficiaries.
Senator Lankford, you are next.
Senator Lankford. Mr. Chairman, thank you.
Let me do a quick follow-up on this, Secretary Becerra, on
what Senator Cornyn was just talking about at this point.
Individuals who are placed in HHS custody with ORR, who are
unaccompanied minors, are they always placed in a home with
someone who is legally present in the country, or could they be
also placed in a home of someone who is not legally present in
the country and we do not know their legal status?
Secretary Becerra. Our authority is to place them with
someone whom we vet, who will provide a safe shelter, and----
Senator Lankford. Do you have any idea of what percentage
of children are placed in the home of someone who is not
legally present in the country at the time?
Secretary Becerra. I could not tell you that right now, no.
Senator Lankford. So, we do not know that? These are
individuals who are vetted, but they are not vetted for their
legal status in the country?
Secretary Becerra. We vet--our responsibility is for the
care and safety of the child----
Senator Lankford. Yes. I am just asking the question. Just
are individuals vetted if they are legally present in the
country? Do we know children are placed in the home of someone
legally present?
Secretary Becerra. And, Senator, I do not want to be--I do
not want to evade the question. What I am trying to tell you is
that our focus is on what are the elements that would make this
a safe placement for the child.
Senator Lankford. But legally present is not on that list
of what is safe?
Secretary Becerra. I would not say to you that that is a
particular object. That does not mean it does not get
considered.
Senator Lankford. But we do not know what percentage of
kids are placed there? I have a lot of other questions, but it
is my understanding that is not a consideration on it.
There is a new rule that has come out on nursing homes that
I will tell you my rural nursing homes are extremely concerned
about. My State is extremely concerned that HHS is creating a
rule that is going to cause the closure of a lot of our rural
nursing homes.
I understand the good intent that is here, but what this is
going to cause is a dramatic rise in prices, and a difficulty
of getting R.N.s into those difficult locations. I would just
encourage you to reconsider that rule. My State is half rural,
half urban, and for those areas that are rural, they still want
to maintain their nursing home. A rule that I did not vote on,
that was created by HHS, is about to cause the closure of a lot
of those rural nursing homes, and I think that is very
significant for us.
So, I am just going to challenge you to reconsider that, so
that our rural nursing homes can stay open in the days ahead.
You know this is coming, because your office contacted us
at 11 p.m. last night to try to answer a question on this. So
let me ask for a little more clarity. Last year, you created a
rule on title X funding that in my State--and my State
currently has laws that protect the lives of every child, born
and unborn--that if my State did not put on our health
pamphlets, brochures, whatever it may be, a way for people to
get access to an abortion, if they did not put that 1-800 phone
number on there, we would lose title X funding.
You followed through on your threat, and you took away
title X funding from my State, which takes away from my rural
counties AIDS testing, cancer screenings. All of those things
you took away from my State, because my State would literally
not put a phone number in our health brochures of where people
could go to get an abortion.
First of all, let me start--that violates Federal law,
because obviously title X funding is not about abortion. That
is specifically in Federal law, so you have created something
entirely new with that. The second thing I would say is, why
would you take away that funding, and is that true?
Would you be willing to put--the funding has been taken
away; my State has lost that money for AIDS testing and cancer
screenings in our county health departments because of that.
Secretary Becerra. So, Senator, I am not surprised by your
question, and you are not going to be surprised by my answer,
in that I do not agree with the way you framed this. Because if
it were as you framed it, we would be in court right now
losing. But the----
Senator Lankford. We are in court right now. There is an
appeal that is going on.
Secretary Becerra. And so far, we are able to enforce the
law as it stands. All the law says is, individuals who are
going in for services should know what services they are
entitled to. We are not saying anything about abortion. We are
just simply saying a person should be informed of the services
that could be available to them under title X, and if a State
wants to not abide by the law, they understand the
consequences. They will not get their money.
Senator Lankford. So, the specific law that you are stating
there is, if we do not put a 1-800 number where to go to get an
abortion----
Secretary Becerra. That is not the case.
Senator Lankford. That is the case. So we have verified
this; we have walked through the process. That is the one issue
when we ask, if we added this one phone number to brochures,
does that fulfill----
Secretary Becerra. To get information----
Senator Lankford [continuing]. And we were told ``yes,''
that would fulfill everything. It is just a phone number of
where to go to get an abortion, because you cannot get it in
the State. So what has happened then is AIDS testing goes away
in my State, cancer screening goes away.
I mean, that is a pretty big bully tactic, to be able to
say, ``I am going to remove all these things if you do not do
what we are asking you to do,'' which is not in the statute.
Secretary Becerra. Senator, we follow the law. We expect
those who want Federal dollars to follow the law.
Senator Lankford. Well, we are also following the law.
Secretary Becerra. Then they will get their money. If they
follow the law, they will get their money.
Senator Lankford. Well, clearly, we are being withheld from
that. I would ask you just a quick ``yes'' or ``no'' question,
because there is another decision that is coming down from the
Supreme Court next week, as they hear about chemical abortions.
There have been some rumors out there to say, and some
individuals saying that if the Supreme Court determines
something about chemical abortions, that HHS and FDA should
just ignore it.
So my ``yes'' or ``no'' question is--we do not know what
direction the Supreme Court is going to take on that decision,
but when the Supreme Court makes that decision, will HHS abide
by that decision, whatever it is?
The Chairman. Briefly, Mr. Secretary. My colleague's time
is up.
Secretary Becerra. Senator, you are asking me to speculate
on something. We are going to do everything we can----
Senator Lankford. I am asking you if you are going to
follow the Supreme Court and the United States Constitution.
That should not be a hard question. You have been a member of
Congress and a member of the executive branch.
Secretary Becerra. We always follow the law.
Senator Lankford. That is all I need to know: yes, you will
follow the law.
The Chairman. The time of the gentleman has expired.
Senator Carper?
Senator Carper. Thanks. Thanks, Mr. Chairman. Mr.
Secretary, welcome to the Finance Committee. So, I am intrigued
by this exchange between the two of you.
When it comes to drug pricing reforms, my principles are
pretty simple: much lower costs for American families. We need
to encourage innovation, we need to improve transparency, and
we need to curb rising costs to the Federal Government. Over
the past several years, I think we have pretty much
accomplished those things. As you know, we passed, and the
President signed into law, the Inflation Reduction Act. This
landmark legislation included many provisions to lower the high
cost of prescription drugs.
The IRA capped the cost of insulin, for example, at $35 a
month for Medicare beneficiaries; made recommended vaccinations
available at no cost; capped out-of-pocket spending for
Medicare Part D beneficiaries at $2,000 annually; and
authorized Medicare to negotiate drug prices with manufacturers
for certain high-expenditure drugs.
We made, I think, historic progress in making health-care
accessible and more affordable. We are not done, but we are
heading in the right direction. We have an opportunity to
continue tackling the rising costs of health care by addressing
the growing public health crisis of obesity. Despite obesity
being formally recognized as a disease, access to medical
treatment for obesity remains limited. The economic and social
impact of obesity has risen to almost $1.7 trillion. That is
trillion, with a ``t,'' dollars per year. The cost of doing
nothing is way too high; too high for American families and way
too high for the Federal Government as we wrestle with
deficits.
That is why I reintroduced the Treat and Reduce Obesity Act
with Senator Cassidy in this Congress. This legislation would
expand Medicare coverage of intensive behavior therapy for
obesity, and would authorize a Medicare prescription drug
benefit to cover medications that are used for the treatment of
obesity.
I have been a proud champion for the Treat Obesity Act now
for over a decade. Investments in obesity as a disease are long
overdue. Mr. Secretary, how will you and your team at HHS work
with us to invest in this prevention and treatment of obesity
in this Congress?
I like to say bipartisan solutions are lasting solutions.
We think this is one of those, and this is a good one. Go
ahead.
Secretary Becerra. Senator, we look forward to working with
you because we know that more and more, with the innovation and
sophistication of technology and science, we are going to have
opportunities to really make a difference in the lives of a lot
of Americans. So we very much look forward to working with you
so that programs like Medicare and Medicaid can be at the
forefront of making sure Americans have access to the treatment
they need.
Senator Carper. Thanks.
The COVID-19 pandemic taught us a lot of lessons. One of
those we now have the opportunity to learn from and grow upon.
One such example lies in the acute hospital care and home
waiver program known as Hospital at Home. We saw the demand for
home-based care rise during the pandemic, when hospitals and
health-care facilities were over capacity and patients
preferred to receive their care at home. The Hospital at Home
program was established under the public health emergency to
meet this demand by allowing Medicare beneficiaries to receive
hospital-level health-care services at their home.
Since its enactment, we have seen the Hospital at Home
program become a true success story. It has proven to deliver
higher reported patient satisfaction along with positive
patient outcomes, and potential cost savings. To ensure that
patients and their providers would have access to the Hospital
at Home program for 2 years--beyond the duration of the COVID-
19 public health emergency--last Congress, Senator Tim Scott
and I introduced the Hospital Inpatient Services Modernization
Act. I am proud the Congress passed this bipartisan bill. It
was signed into law by President Biden last year.
Mr. Secretary, what lessons have we learned from the
success of the Hospital at Home program?
Secretary Becerra. Senator, I hope that we are able to
report pretty soon on all the lessons, because the study that
was required by the legislation will give us an opportunity to
see how we can do this. But no doubt, I share your interest in
making sure that people in America can receive the care they
need where they can get it, and as efficiently as they can and
when they need it.
And so, the studies that we are going to be putting forward
should help us understand how we can try to move in a good
direction for folks who need care. Oftentimes, it could be in
their home. So we look forward to working with you on that.
Senator Carper. All right. Well, we look forward to it as
well. My colleagues hear me say often, ``find what works; do
more of that.'' We think this is something that works and that
we are going to want to do more of. We look forward to working
with you, and again, this is one of those pieces of legislation
that has bipartisan support.
I am grateful to Senator Cassidy, Dr. Cassidy, and everyone
who has joined us in this effort. Thank you so much.
The Chairman. I thank my colleague.
Next is Senator Casey.
Senator Casey. Mr. Chairman, thanks. Mr. Secretary, good to
have you back here, and thanks for your service to the country
at a difficult time.
I want to start with the issue of prescription drugs. I am
grateful for your work and the work of the administration on
efforts to lower the cost of prescription drugs. We all know
that prescription drug costs in our country are significantly
higher than so many of our competitor nations. I voted for the
Inflation Reduction Act, which had a provision to allow
Medicare, for the first time, to negotiate for lower prices. It
also had that $35-a-month cap on insulin for Medicare Part D
beneficiaries.
I am just holding up here--it is an enlarged version of a
piece of paper I put out a couple of months ago now to
summarize the benefits of the Inflation Reduction Act
prescription drug provisions, just in Pennsylvania, just to
give you an example. There is a lot you cannot see from where
you are sitting.
But just the capping of insulin at $35 a month, 80,200
Pennsylvanians will benefit from that. And then another one,
just for highlight, we know that less than a year from now, the
$2,000 out-of-pocket cost cap will go into effect. That will
impact nearly 829,000 Pennsylvanians. So, big numbers just in
one State.
I wanted to ask you to give us a state of play: what is
already in effect and how it is working, and then what has the
administration proposed in the budget to further expand
policies and measures that will continue to ratchet down the
cost of prescription drugs?
Secretary Becerra. Senator, we may ask you for a copy of
that document that you just put up, because we could always use
anything that helps convey information to consumers. Thirty-
five dollars a month for insulin is lifesaving in many cases
for many people. But for folks on fixed incomes--you know how
important that is for seniors who have to depend on their
Social Security check to pay for things.
The fact is that today, if a pharmaceutical company tries
to raise the price of its drug beyond the rate of inflation, we
now get to yank back the extra that they are charging beyond
the rate of inflation. That is a big one. Today, we are in the
midst of negotiating for the 10 costliest drugs in the Medicare
program, which in 2022 cost Americans just in Medicare, 65
million people on Medicare, $46 billion.
We are going to finish that, the negotiation, by August. We
will be announcing what the price will be come September. That
is already in effect. Those prices would then come into play at
the beginning of 2026. Next year, we will get to negotiate
another 15 drugs. And as you have heard, President Biden would
like us to negotiate not just another 15, but another 50,
because we are going to be saving a ton of money.
The Congressional Budget Office has said we are probably
going to save at least $100 billion in just negotiating for
better prices in those first 10 drugs. On top of that, you are
aware--and this is very important for a lot of seniors in
Pennsylvania and throughout the country--the cap on how much
they will have to spend out of their own pocket, it has already
begun this year, a cap of about $3,500 for catastrophic costs.
But by next year, when people are paying for these drugs, if
they are on a cancer drug or have kidney failure--tens of
thousands of dollars, today, they pay out of pocket, because
their cap is really high. Next year, the cap will be $2,000
overall. A game-changer for so many Americans.
Senator Casey. And that $2,000 cap goes into effect January
1st, correct?
Secretary Becerra. Yes, next year.
Senator Casey. And then, can you just briefly walk through
proposals for some of them you mentioned? You said the
President proposed 50 more prescription drugs to be negotiated.
Secretary Becerra. We know what works. If CBO, the
Congressional Budget Office, is telling us for just these 10
drugs, we will save $100 billion for taxpayers, why do we limit
it to 10? You all were good enough to help make sure that next
year it is 15 we negotiate. But the President is saying, why
stop a good thing? Let's negotiate more of these, because we
know in America we are paying two or three times the cost for
these drugs than other people around the world.
Senator Casey. Well, I appreciate that.
And the second issue that I wanted to note is how grateful
I was that the President's budget includes a provision to allow
States to provide continuous Medicaid eligibility for children
under the age of 6. This continuous eligibility will reduce
gaps in coverage and access to essential care services for
kids, such as preventive care.
Ensuring kids have access to high-quality, affordable
health care is of course one of our number one priorities. And
I introduced legislation, the Medicaid for Every Child Act,
which would automatically enroll all children, all children
through the age of 18, in Medicaid.
How is HHS working to expand access to health care for
children? I know I do not have much time, but just a brief
summary.
Secretary Becerra. Well, you have mentioned a very
important aspect to it that the President has in his budget. We
are also trying to make sure that we provide care from the very
moment of birth, in fact beyond, because we are focusing on
maternal health. Because too many women in America, believe it
or not, in the richest country in the world, are dying, or
their babies are dying at the time of birth or within the first
year.
And so today, we offer a woman who is on Medicaid not just
60 days of postpartum care, but 365 days. Fortunately, so far,
45 of the 50 States have adopted that. And so, that is going to
help kids moving forward to start off on the right track. There
are any number of things we could mention Senator, but I know
your time is short.
Senator Casey. Thanks so much. I appreciate it.
Secretary Becerra. Thank you.
The Chairman. I thank my colleague.
Let's just consult the board here. Senator Johnson is next.
Senator Johnson. Thank you, Mr. Chairman. Secretary
Becerra, welcome.
Secretary Becerra. Thank you.
Senator Johnson. I think you may be aware, I have written
over 60 oversight letters having to do with our response to
COVID, the vaccine, vaccine injuries, to your agency and to
your subagencies. I want to talk about three of those primary
requests.
The first is on the origin of COVID and Anthony Fauci's
emails. In June 2021, 4,000 pages of his emails were released
under a FOIA request. Within a week of that, I had five members
of the Homeland Security and Governmental Affairs Committee
sign a letter requesting those 4,000 pages unredacted.
Let me first ask the question. You do agree to the fact
that under FOIA, those requests can be redacted for a host of
reasons. But congressional oversight, we are not subject to
those redactions, correct?
Secretary Becerra. Senator, I do not want to speak out of
turn. But we continue to make sure that we protect confidential
information, the privacy of information, and we try to do the
best we can to respond to congressional requests.
Senator Johnson. But again, we are not subject to those
same redactions, and the U.S. Code--5 U.S.C. section 2954--
states that an executive agency on request of the Committee on
Governmental Affairs, any five members there, shall submit--
shall submit--information requested of it.
So as an accommodation, we went from 4,000 pages, requested
400 pages unredacted. Over the course of a number of months, we
were allowed in a reading room. We got 350 pages, we were able
to look at them; could not take copies, could take notes. We
are down to the last 50 pages of the Fauci emails. [Holding up
a series of completely blacked-out pages.] I was hoping that
you would bring these unredacted, because last year, in this
similar hearing, I asked you about these, and you said, ``You
are absolutely entitled to the information that by law a member
of the Senate or the House should get.''
Again, the law is 5 U.S.C. 2954. It states you shall turn
those over to us. Why haven't you turned those over to us here
a year later?
Secretary Becerra. And, Senator, you know, I will try to
make this as clear as I can, because Secretaries before me and
others who have testified before me have tried to answer this
question that many Senators and House members have asked in the
past.
It is an accommodation process, where we try to make sure
that we fulfill the request as best we can, without undermining
national security, confidentiality, and the interests of----
Senator Johnson. So, Mr. Secretary, you realize if you are
withholding information from Congress required under law, that
at a minimum you should be providing me a privilege log
justifying the reason you are withholding this information.
This has been a year since you said that I was entitled to the
information that is required by law.
We have not gotten a response from you. We have not gotten
a privilege log. Why not? Why haven't you listed the privilege
you are claiming to withhold these 50 pages unredacted? What
privilege is it that you are claiming to withhold this
information, not only from Congress, but from the American
public? What is the privilege being claimed?
Secretary Becerra. And, Senator, I know that your staff has
been engaged with our team when it comes to trying to respond
to some of the requests. We will continue to try to respond the
best we can.
Senator Johnson. Well, you have not responded. You should
have provided us a privileged list, a log, so we can understand
what privileges you are asserting in withholding this
information from the American public. So, I am expecting that
privilege log post haste, okay?
Now let me move on to two other things. There was a
standard operating procedure issued in January 2021, shortly
after the vaccine got its emergency use authorization, laying
out the analysis that FDA and CDC were going to do on the
Vaccine Adverse Event Reporting System.
First, reporting ratio--we have gotten the run-around on
that. Finally, you said it was going to be empirical Bayesian
analysis. I have written, I think, five or six oversight
letters, trying to obtain that analysis on the VAERS system. I
have not gotten bubkis. I have not gotten anything on this
whatsoever.
Why is the FDA, and CDC, why are they withholding their
analysis of their Vaccine Adverse Event Reporting System? We
fund the agencies. We pay their salaries. That data should be
made available to the American public. Why is it not? Why are
your agencies withholding that information?
Secretary Becerra. Senator, I will try to make sure I can
get back to you. I cannot speak directly for the actions of
FDA, but what I will tell you is that we try to be responsive
to any requests we get----
Senator Johnson. You have not; your agencies have not been
responsive at all. They are giving me the middle finger. They
have been giving me the middle finger for a year. So, Mr.
Secretary, I would request a phone call within a week or 2. You
check into this.
I have also got--I have run out of time--some significant
questions about hot lots, that the agencies are completely
ignoring. I mean, things like over 5,000 adverse events with
one lot of COVID vaccine versus the most adverse events
associated with one flu lot, 137. These are serious issues, and
the American public deserves this information. So I would
expect a phone call personally from you with the privilege log
and responding to why you are not releasing the analysis on
VAERS. Why can't I get a legitimate response in terms of hot
lots that have been identified repeatedly by a number of
outside researchers?
The Chairman. The time of the gentleman has expired.
Senator Cortez Masto?
Senator Cortez Masto. Thank you. Thank you, Mr. Chairman.
Mr. Secretary, thanks for being here. I appreciate it.
First of all, thank you for the incredible work that you
and your team are doing around prescription drug negotiation as
authorized by the Inflation Reduction Act. It is so important
for seniors and so many across the country, to lower drug
prices. So, thank you. I also recognize that big pharma is in
court right now trying to challenge your authority under that
legislation, which unfortunately is happening. In addition to
the Inflation Reduction Act negotiation, we also imposed caps
on out-of-pocket spending for seniors for the first time.
And so, how is the initial out-of-pocket cap, which was put
in place just January of this year--it is just the initial--
benefiting seniors right now, and how might that change when
the $2,000 cap is in full effect next year?
Secretary Becerra. Senator, thank you for the question, and
thank you for your work. I know Nevadans are able to keep a
little extra money in their pocket because of the work that you
and your colleagues have done to lower the cost of prescription
drugs.
Many Americans, especially those who are in Medicare who
are getting older, have very high costs for medication. They
are perhaps suffering from cancer. Maybe they are having kidney
failure. But oftentimes, their costs are extremely high, and
while Medicare provides a lot of support and pays for a lot,
out-of-pocket costs can be very high for some individuals. It
can be into tens of thousands of dollars.
Today, this year, the catastrophic cost limit kicked in as
a result of the President's lower-cost prescription drug law,
which means that no senior today, for those catastrophic costs,
pays more than about $3,500 out of pocket. Next year, starting
in 2025, the most for those medications that any senior will
pay out of pocket will be $2,000. That is a lifesaving measure
for many people.
Senator Cortez Masto. And that is true, as I have heard
from so many of my seniors. How do they become aware of it
though? Is your agency pushing information out so seniors are
aware?
Secretary Becerra. We are trying to get that information
out, but a really quick story. I had a senior come up to me and
say, ``I went back to my pharmacist because when I saw what
they had charged me for my insulin, I felt guilty that they had
undercharged me. So, when I went back to the pharmacist, I
said, `You undercharged me,' and the pharmacist said, `No, that
is the new price, $35.' ''
She was just up in the clouds, because this is a senior on
a fixed income who had been paying, I think, $117 a month.
Thirty-five dollars--that is real money in her pocket.
Senator Cortez Masto. Yes, it makes a difference. It makes
a difference for so many of my seniors as well.
Let me jump to mental health. Every single one of Nevada's
17 counties is designated a health professional shortage area,
also known as HPSA, as you well know. All 17 counties are
primary care shortage areas, and 16 out of 17 Nevada counties
are designated as mental health shortage areas. The President's
budget proposes to extend the 10-percent incentive payment for
physician services provided in shortage areas to include a
broader range of clinicians and behavioral health
practitioners.
This committee has also passed a bipartisan package
allowing more mental health providers to receive an increased
bonus for practicing in shortage areas. Should this increase in
shortage area bonuses become law, providers across Nevada would
see an increase in their Medicare reimbursement.
My question to you is, many shortage areas lack a
physician, but Nevadans may have access to a nurse practitioner
or a clinical social worker. So, has HHS evaluated how
extending the range of clinicians eligible for the HPSA bonuses
might impact our workforce challenges, particularly in our
rural communities?
Secretary Becerra. Yes. Great question, Senator, because
you are right. We learned that, especially as a result of
COVID, there are health professionals who may not be physicians
who can do some of the work that right now they are prohibited
from doing. So we are working with States, because the
licensing issue is at the State level. So, for certain
practitioners, a nurse practitioner for example, to do things
beyond what is currently provided by State law, we have to have
the States make amendments.
And so, we are working with them, because COVID taught us
that a lot of health professionals are ready to go. They just
have to be free from those constraints.
Senator Cortez Masto. Well, I appreciate that, and it is
one thing I know, working in my State, and you as a former
Attorney General recognize, that at a Federal level, there is
only so much jurisdiction you have, and it does require either
State or local community government partnership here when it
comes to looking out for the best interest of our kids, or
whether it comes to opening the door for access to more
physicians or doctors or mental health clinicians coming into
the State.
There is a role for the States to play as well, and I
appreciate that work that you and your staff are doing, that
partnership. Thank you.
Secretary Becerra. Thank you.
The Chairman. I thank my colleague.
Senator Cassidy is next.
Senator Cassidy. Secretary Becerra, thank you for being
here.
First, Senator Menendez and I have requested a TA for
coverage for dialysis patients. I have a TA request in for the
Connected MOM Act, to allow mothers at risk for problems in
their pregnancy to get stay-at-home monitoring.
We have--it is outstanding for months. Now, I know your
staff is incredibly busy. You get lots of requests, but this
actually will save lives. So can I ask that you ask your staff
to get these fulfilled ASAP?
Secretary Becerra. I agree with you, these are important.
Let me ask. As you know, CMS is right now besieged with so many
different things, the latest being this Change Healthcare
cybersecurity attack. But let me get to them and say that this
is important, and see if they can work with you to double the
speed.
Senator Cassidy. I appreciate that.
Now let me next ask about HHS data modernization. Is that
an in-house data platform that HHS is using, or do you do like
the Department of Defense does and contract with others who are
cloud-based like AWS or Palantir or somebody like that?
Secretary Becerra. You know, Senator, I will be honest with
you. I want to get back to you, because I do not want to give
you misinformation. But if you give us the name after this
hearing of who your person is on staff, we will make sure we
are in communication to get you that correct information.
Senator Cassidy. Sounds great. Related to that, there was
this recent finding by the--an acronym--the National
Association of ACOs, which published data suggesting that seven
fraudulent companies stole $2 billion in Medicare payments in
2023, and they did that using a virtual research data center to
find the fraud.
Now that is all good. Of course, I would like for CMS to
have been on top of it, and that is why I would like to talk to
you about data modernization at some point in time. I am also
told that academics have used this data. They do not have the
ability to purchase it, so they have relied upon CMS to stream
it.
And so, I was a little surprised when CMS announced last
month that it would discontinue sharing data with institutions
beginning August 19th, and require all researchers to move to
the fee-based virtual research data center. That is fee-based,
right? [Turning to staff.] Yes. Now I understand the per-user
price for that is quite high.
So, I do not know if you are going to lower the price for
the academics, or if you continue, have you done an analysis on
how many fewer researchers and students will be able to access
the data if you go to this, et cetera?
Secretary Becerra. Senator, we are in the process of
reviewing this. We are in fact--we have a solicitation for
information to get responses back. As you know, this is a
fairly new area. We want to be more aggressive in getting
everyone on board. Every sector within health care has to get
into this, because no one can keep their data doors unlocked
with these cyberattacks that are occurring. So, we are trying
to get the best information we can to know exactly how to
proceed.
Senator Cassidy. Sounds good. So, I think, I think you are
open to allowing researchers to have it either at a discounted
price or some way, but they would not pay the full freight of
somebody who is doing it as a for-profit?
Secretary Becerra. Yes. I will not speak to where we will
go. I will tell you we are open, because we are trying to learn
as everyone else is trying to learn.
Senator Cassidy. Okay. Would you give me a follow-up on
that----
Secretary Becerra. Absolutely.
Senator Cassidy [continuing]. Because the researcher who
approached me has been incredibly helpful to this committee,
whether the committee knows it or not, because she is just fed
into our office, and the fact that she might not have it will
be deleterious.
Secretary Becerra. I would invite you or your team to help,
because we are trying to get everyone to give us their best
information, because we do not want to miss anything,
especially for the little guys. The big guys could probably
afford to do some of these things, but for the little guys, it
could be very expensive. So, any information you are getting,
we would love to have it.
Senator Cassidy. Sounds great.
You know I have been interested in return to work. Can you
tell me what percent of HHS employees and CMS employees are
currently 4 days a week or more in the office?
Secretary Becerra. Sure. What I could tell you is that, as
you know, because HHS was involved with COVID, we have been
working from Day One, and we continue to have folks come into
the office to work. I can tell you that we are complying with
the Office of Management and Budget's guidance when it comes to
in-office work levels. We have a variety of----
Senator Cassidy. And what is that right now?
Secretary Becerra. I'm sorry?
Senator Cassidy. What is that requirement?
Secretary Becerra. The requirement is not a straightforward
requirement, because there are a lot of different work
schedules and work----
Senator Cassidy. But just at HHS, typical employee. Would
it be 1 day a week, would it be 3 days every month? Would it be
4 days a week?
Secretary Becerra. Yes. NIH researcher, every day. IHS
caregiver, every day.
Senator Cassidy. But the HHS building, that one down the
street?
Secretary Becerra. The HHS building. Most of us probably
almost every day because we are in----
Senator Cassidy. Those are political appointees. What about
the nonpolitical appointees?
Secretary Becerra. There, where you have some flexibilities
for some of the career staff, it could be 3 out of 5 days a
week; it could be 4 out of 5 days. It depends on what their job
is.
Senator Cassidy. What is the least amount it could be?
Secretary Becerra. Well, there are some folks who get to
telework altogether, because their job is essentially in front
of a computer. And so, what we are trying to do is make sure--
--
Senator Cassidy. Now, are you monitoring VPN data or
anything else to measure productivity?
Secretary Becerra. Yes. We could use your help, because the
systems we are using to monitor are from back in the 1970s and
1980s. So it has been difficult to really get the dots
connected.
The Chairman. The time of my colleague has expired.
Next is Senator Cardin.
Senator Cardin. Mr. Secretary, welcome. It is wonderful to
have you before our committee.
I want to ask you first in regards to some of the actions
you have taken in regards to oral health. As you know, oral
health is critical to overall health, and you have provided
some additional medically necessary determinations in regards
to coverage under both Medicaid and Medicare.
And I guess I want you to be able to continue to recognize
that a lot of the services are medically necessary that
traditionally have not been covered under these programs. So,
can you tell us how you are using the authorities that you have
to expand access to medically necessary oral health?
Secretary Becerra. So, Senator, I know that we are trying
to expand access to health in rural communities, because we now
see a contraction. And what we are trying to do is, where you
all have given us authorities to actually provide flexibilities
in the way some of these providers operate, we will do so.
Sometimes it is difficult because there are consequences,
especially if you have a net neutral system of funding, to make
some of those resources available. But we try to stretch where
we can. We could certainly use your help in making sure that
the authorities we have allow us the flexibility to really
reach most of rural America when it comes to health care.
Senator Cardin. We want to work with you in a process
within CMS to evaluate clinical evidence for additional dental
services, to determine when they are medically necessary for
beneficiaries. We know that sometimes this is a struggle in
interpretation, and I know Senator Stabenow and I have been
working on this issue, and we will be glad to try to give you
the additional authorities if you need additional authorities.
But we think under the Affordable Care Act, you have
certain abilities that you can use to deal with medically
necessary services, and you can use that in order to try to
expand care.
Let me ask you, in regards to the issues concerning--this
committee has been very concerned about the transplant issues
and the quality issues. Can you tell us the status of making
sure that we can have fair competition and quality in regards
to the system reforms related to transplantation of organs?
Secretary Becerra. We are trying to move aggressively with
the reforms that Congress enacted, which really reflected the
reforms that we had proposed in regulatory channels. What we
will need though is resources, because we are trying to set up
a new, independent board that will monitor the transplant
activities.
We are trying to create a robust system of competition,
just to see who will operate the system, and we need help to
make sure that we can get this done as quickly as possible,
because I think everyone agrees that the resources we need to
bring us up to date are not there. I hope that in this budget
process, we are able to get some of the resources that the
President has proposed in his budget.
Senator Cardin. So, let me ask you about another subject
that I have been raising for a long time, and that is dealing
with drug shortages. It is amazing in the wealthiest country in
the world, that spends the most by far on medicines, that we
have relatively inexpensive drugs that are in short supply and
are compromising the quality of health care in America.
I find that outrageous. We have tried to deal with shelf
life and to give some flexibility, so that drugs that are still
effective--that we do not have those shortages. But we find
that without some system of carrot and stick, we are going to
always have these shortages, and that is unacceptable.
So, can you tell me the strategy that you are deploying in
order that Americans have access to critical medicines that are
not difficult or expensive to produce, but because of the
manner in which our market works, these drugs are in short
supply?
Secretary Becerra. Absolutely, Senator, and thanks for the
work that you have been doing on this subject. Our problem is,
our current statutory authorities really only give us sight at
the end stage when, at the retailer level, we start to see the
shortage: people cannot find the drug on the shelf, they cannot
get it from the pharmacy.
We are asking for authority so we can actually see a
shortage or a constriction occurring at the early stage, when
that medicine is being manufactured. Waiting until the retailer
says, ``I do not have enough,'' is way too late. So we are
asking to be allowed to have greater insight into what the
manufacturer sees, so the manufacturer has to alert government
whether or not they see shortages occurring at their stage.
The second thing we would like to do is make sure that we
try to bring home much of that manufacturing, because we should
not be dependent on China and other countries for the materials
that it takes to create these pharmaceutical medications. And
so, we would like to bring some of that manufacturing back
home. The President includes about $95 million to make it
possible to actually have manufacturers base their operations
here in the U.S.
Senator Cardin. Thank you.
Mr. Chairman, I will have a question for the record in
regards to orphan-type drugs or drugs that are taking a long
time under FDA, where the life expectancy is short. I will have
a question for the record in that regard.
The Chairman. Senator Cardin, thanks for your good work on
the drug shortage issue, and it has been good to work with you
on it.
Senator Brown?
Senator Brown. Thanks, Mr. Chairman. Mr. Secretary, nice to
see you again. Thank you. So much in the IRA mattered in
people's lives. It's something in Toledo, on a whole other
subject, that mattered to people there.
I want to thank you specifically for your work on
prescription drugs, one of the most important things we did.
Thirty-five-dollar insulin--72,000 Ohio seniors will benefit;
219,000 older Ohioans who rely on the ACA will benefit. We want
to expand, as I know you do, and Senator Whitehouse and I have
worked on this, to expand the insulin cap to everyone, not just
Medicare beneficiaries.
The Federal Government is negotiating better prices for
patients. Many years ago, when you and I served in the House
together, I used to take buses to Canada, about 3 hours away.
People would be able to fill their prescriptions with
negotiated prices the way our own VA does, saving 50, 60, 70
percent. We can do that now, and thanks for your work on that.
So, walk through briefly, because I have another topic I
want to talk about, how this will all work. How can you, how
can HHS work to implement the law to ensure lower prescription
drug costs?
Secretary Becerra. So, Senator, it is already in effect, as
you mentioned, with insulin. We see how it is working. I have
had any number of conversations with a lot of seniors who rely
on their Social Security check, essentially for their day-to-
day living. When they hear that $35 is all they will pay now
for their insulin, where before they were paying $100, $150,
$250, it is a godsend for them. The fact that today, we can
yank back the extra profits that a pharmaceutical company is
making if they try to raise the price of that drug by more than
the rate of inflation, that is a great thing for Americans on
Medicare as well.
The fact that today, the out-of-pocket costs for a senior
are now being limited, so that even if you have to use that
expensive cancer drug, you will not pay more than about $3,500
out of pocket. That is still a lot of money----
Senator Brown. And that number comes down.
Secretary Becerra. And next year it comes down to $2,000
total. And for folks who are paying tens of thousands right
now, that's real money.
Senator Brown. When you think about what this Congress and
the last two have done in terms of restoring, in my State,
100,000 union workers' pensions; what the Child Tax Credit did
temporarily--we keep moving on it--dropping poverty rates by 40
percent; and what we are doing on drug prices, I mean, it
affects huge, huge numbers of people who need a little bit of
help in their lives. Thank you for that.
I want to shift to East Palestine. You and I have talked on
the phone about it, the site of the train derailment in eastern
Ohio, just slightly into western Pennsylvania. Senator Casey is
on this committee.
I made my ninth trip there this week. The administration
has announced a few NIH grants to get some work underway on
health monitoring. That is a really good first step. I have
asked HHS to set up a voluntary disease registry for the
residents of that community, and I just wanted you to commit to
working with my office and the residents of East Palestine and
its surrounding communities, including Senator Casey's impacted
constituents, on a voluntary disease registry and additional
resources for long-term health monitoring.
Secretary Becerra. Senator, look. I thank you for your
leadership on this, on East Palestine. You know, I feel like
you are always nipping at my behind on this one, and making
sure we are doing something. I am glad we were able to get
$250,000 to that local community health center right after the
incident occurred, to help them out.
We are glad we sent CDC out there to do the in-person
surveys, to help find out what the health status was of people.
NIH now, this year, announced six grants that are going out to
help understand what is going on there for the folks in East
Palestine, and we are absolutely prepared to work with you and
State and local partners on this issue, on a registry and these
other matters.
Senator Brown. Thank you.
Two other quick things. I appreciate the commitment you
made, when we talked during last year's budget hearing, to use
a project labor agreement during the construction of the new
CDC NIOSH facility. NIOSH is an institution--the National
Institute for Occupational Safety and Health--unlike any in the
world--in Cincinnati, OH. They make a huge difference for
workers, by studying and understanding workers' illnesses and
diseases and injuries and other matters for--I mean, it really
is about the dignity of work. Thank you for that, and I look
forward to working with you to make sure we have the resources
to see this project through to completion, and to get that PLA
in as quickly as possible.
The other thing is, we spoke recently about the financial
issues of the Salem Regional Medical Center. It happens to be
in the same county where East Palestine is. The train going
through Salem was actually on fire before it derailed 8 miles
later in East Palestine.
So that regional medical center faces problems because of
an error by one of Medicare's regional contractors. I need your
commitment to continue working with me to ensure that we
deliver timely solutions, to ensure that we can keep providing
care through the Salem Regional Center, if you would.
Secretary Becerra. We are prepared to continue to work with
you, Senator.
Senator Brown. Good. Thank you, Mr. Secretary.
The Chairman. Senator Brown, I thought you would be
interested. A couple of years ago, you were enormously helpful
in our creating that price-gouging penalty, you know, where
drugs were way over inflation.
The Secretary confirmed that just one of those drugs--and
they are of course in the doctor's offices, Part B of
Medicare--is saving $600, more than $600 per dose. So I just
wanted to say ``thank you'' for your efforts on that.
Senator Barrasso?
Senator Barrasso. Thanks, Mr. Chairman.
Mr. Secretary, thanks for being here. Good to see you
again.
I wanted to turn to the crisis at the southern border, and
how it is overwhelming our health-care system here in the
United States. What we see on the news, reported and written,
and on video and television, hospitals in sanctuary cities
right now--New York City, Denver, San Diego, Chicago, Boston--
tell us that they are at risk of collapsing financially due to
the overwhelming number of illegal migrants flooding their
emergency rooms and their clinics, and essentially getting free
care, having the American people pay for their care.
A clinic in Chicago reported seeing nearly 16,000 migrants
last year, illegal immigrants. The cost of their care totals
over $30 million. This is what the hospital is reporting, paid
for by American taxpayers. Denver Health was in the headlines
in 2023, reporting over 20,000 hospital visits from migrants.
The hospital is now, not surprisingly, in financial distress.
These hospitals are now asking the Federal Government to
bail them out, and it is completely a Democrat-caused failure
to enforce the law at the southern border. Can you please
explain why it is the responsibility of hardworking American
taxpayers to foot the bill for all of this care for people, 9
million now from all across the world, who have flooded their
way into the United States?
Secretary Becerra. Senator, I appreciate the question. What
I could tell you is that we have extended the resources and
authorities that we have at HHS to try to be there to help any
health-care facility, when there is a way that we can go in to
be supportive. I do not know the particular case that you might
want to mention, but I know that we are prepared to be
supportive of any facility where the authorities that you have
given us allow us to go in and support.
Senator Barrasso. Well, in terms of--it is not hard to find
stories about hospitals in one sanctuary city after another
saying they are overwhelmed with the number of people that they
are treating, and have no way to recover the costs other than
to turn to the American taxpayers.
The Federal Government does not pay for the health care of
every legal U.S. citizen. It seems like it is in the position
now of having to do it for all these illegal immigrants. Why
should the American citizens be forced to pay for illegal
migrants to receive this same care for free, because that is
what is happening?
Secretary Becerra. Senator, as I said, I do not know how
particular States operate their health-care systems with regard
to the folks who are coming in. But what I can tell you is that
when we are approached, whether it is through the Medicare
program, the Medicaid program, or simply those who are seeking
other types of authorities and funds that could help them, we
are ready to try to be responsive.
Senator Barrasso. You are aware that when a hospital is
inundated with people who are not paying, they have to shift
the cost to the people who are paying, and that is what is
happening right now all across the country, and specifically in
so many of the sanctuary cities.
I want to talk to you a little bit about something that
Senators Lankford and Crapo asked about as well, and that is
the nursing home staffing ratio requirements. Specifically,
your department is proposing a rule on nursing home staffing
ratios, requiring a registered nurse to be present 24 hours a
day. Currently it is required for 8 hours.
CNA hours per patient per day are increasing. And the
hardship exemption for rural communities that cannot find
people to hire, even though they try very hard, it is requiring
much more paperwork. Most of the Wyoming nursing homes that I
talked to said they would have to actually hire additional
staff, not in addition to taking care of the patients, but to
just fill out the paperwork that your department is requiring.
We had concerns. We expressed them to the Director of
Medicare and Medicaid, Brooks-LeSure. She shared that the
Centers for Medicare and Medicaid have committed $75 million to
support nursing staff in nursing homes. How do you plan for
these funds to reach these rural communities that are really
getting hammered by these additional rules? About four out of
five nursing homes say they cannot comply with what the
administration is now forcing upon them all across the country.
Secretary Becerra. Senator, you packed a lot into that
question. Let me respond first to the issue of the funding, how
we can make sure that it gets into the rural communities. One
of the things that we have done is make sure that we try to get
those dollars into the communities that need it most, to be
able to staff up.
But I must tell you, if you are going to call yourself a
nursing home, you should have a nurse that is present to
provide care to the families that are leaving their loved ones
there. It is embarrassing that, while not one of every five
Americans lives in a nursing home--nowhere near 60 million
people live in a nursing home--one of five people who died from
COVID died in a nursing home.
We need to make sure that the standards that these homes
have for the people that we love and leave in their custody
will be the right care, and it will be with professional
standards. All we are seeking is to make sure that all nursing
homes--many of them already do this--but all nursing homes meet
the standards that you or I would expect if we are going to
leave our loved one there.
Senator Barrasso. Well then, Mr. Chairman, let me just
say--and my time has expired, so I will not go to additional
questions. Only one in five nursing homes can meet the proposed
requirements. Even those trying to hire people cannot find
people to fulfill it. So four out of five nursing homes, they
are going to be out of compliance with administration rules,
and apparently what you are saying is that all of the nursing
homes, these other nursing homes, are right now incompetent to
provide care. But they are still providing pretty good care
today.
Thank you, Mr. Chairman.
The Chairman. The time of the gentleman has expired.
Senator Bennet?
Senator Bennet. Thanks, Mr. Chairman. This is not the topic
I was going to come to address today, but my dear neighbor from
Wyoming raised Denver Health, and I feel like it is really
important for me to respond. I want to make sure I do that
before you leave.
First of all, Denver Health is a national treasure. I do
not think the doctor would disagree with that. It is a critical
public access hospital for the western United States, not just
Denver. It serves the entire metro region. It has a massive
problem because of the amount of uncompensated care it covers,
even without the current immigration crisis that we are talking
about, because we, unlike every other industrialized country in
the world, do not have a system of health care where people
know they have insurance, where people know they can get care.
And so, the doctors and nurses at Denver Health are left to
cover the uncompensated care that no one else will cover,
because no private insurance company will cover it or no other
hospital will cover it. There is Denver Health sitting there in
the middle of Denver, not just covering it but saying ``send me
the people that are uncompensated, because we have a moral
obligation to cover.''
By the way, the taxpayer covers that care too. It is not
like the taxpayer is somehow off the hook. We are paying for
that because of our broken health-care system. So what I would
say to my colleague from Wyoming is, let's work together to fix
our health-care system so we do not have the immoral crisis
that we have because people are not covered in this society.
That is point number one. Point number two, it is not
Denver Health's responsibility, or dare I say--I think the
Secretary would agree with this--Denver's responsibility or
even Colorado's responsibility to fix the immigration system in
the United States of America.
The Founding Fathers of this country understood that
Congress would have to fix the immigration system in this
country and be responsible for it because, even in the 18th
century, it would have made no sense to imagine that this was
something we would leave to the States or the cities, or to a
public hospital in the middle of Denver, CO to address.
We just had the opportunity to try to fix some of the chaos
at the southern border of the United States, which I completely
agree the American people are tired of, for good reason. I do
not think that we should be allowing transnational gangs to set
the immigration policy of the United States of America. I think
that is a mistake.
Because we have failed to act, that is who is running the
immigration policy for this country, in some respects. That is
why so many people are showing up to the border. That is why
the border is overwhelmed. And in the context of this Ukraine
negotiation, we had the opportunity to try to address this in--
in my opinion--a very incomplete way, but we were going to
address it, and the other side walked away from their own
negotiation, even though it was the quote-unquote ``toughest
border bill that ever had been agreed to.'' And now they are
coming here and beating on Denver Health for the uncompensated
care that they are providing, because that is what honorable
nurses and doctors do. That is what an honorable community
does.
It is the responsibility of the Federal Government to deal
with this, and not just to point fingers at each other. And I
will say it--you know, I wanted to ask you about mental health,
Mr. Secretary, and the mental health epidemic that is raging
among adolescents, young people in Colorado and across this
country, something that we have to address as well.
But let me mention one last thing before my time is
expired, and that is this. Two weeks ago, in The Wall Street
Journal, okay--not the failing New York Times, not Pravda, but
in The Wall Street Journal--they had a poll on immigration, and
they asked about eight policies of the people who took that
poll in The Wall Street Journal for the American people's
support.
Number one, with 74 percent, was a pathway to citizenship
for the 11 million people in this country who are undocumented,
the people who spent 30 years in Oregon and in Colorado picking
fruits and vegetables. The American people have too much common
sense not to know that is a good idea. Second was the Dreamers.
Third was dealing with the border.
My point--and I will stop, Mr. Chairman--is that we need a
comprehensive solution to this problem. It is well understood
we can come here and score political points. We have to fix the
problem, and Denver Health deserves the support of this
committee, not an attack on the work that they are doing.
The Chairman. As much as I agree with Senator Bennet's
common sense, we have to move on to Senator Blackburn.
Senator Blackburn. Thank you, Mr. Chairman, and, Mr.
Secretary, thank you for being with us today.
I know we have talked some about the unaccompanied minors
who have traversed that southern border. A big part of the
solution is to secure that southern border.
Now, these children who found themselves in the custody of
HHS and the Office of Refugee Resettlement--and what we have
seen during this surge is the administration's inadequate
ability to actually handle the capacity of unaccompanied alien
children that are coming into this country.
Instead of fixing the border, which is what we would have
liked for the President to do, you pressured your staff to
expedite the release of these children, prioritizing speed over
due diligence. In fact, in a video and a Zoom call with your
staff that I viewed, you actually said this, and I am going to
quote you: ``If Henry Ford had seen this in his plant, he would
have never become famous and rich.''
Now you made that comment, talking about how to assembly-
line process children who were coming into the country. Over
due diligence, over safety, you prioritized speed and moving
them on out. Now the OIG, your HHS OIG, recently reported that
your staff did not make timely safety and well-being calls, if
they made them at all. Twenty-two percent were late, months
past the time they were due, and 18 percent never went out at
all--at all. And it also found that the staff skipped essential
safety steps such as ensuring that the sponsors did not have a
criminal record or that they were not sex offenders.
So it should be no surprise that we are continuing to hear
reports suggesting the existence of trafficking schemes that
are preying on these vulnerable individuals, allegations that
we are hearing of coercion, of forced labor. And despite my
persistent inquiries on this issue, your staff has stonewalled
getting answers back to me.
Now, I have written you twice. I got responses that were
non-
answers from your Assistant Secretaries, one of them being over
6 months late, and I got it just last week before this hearing.
Mr. Secretary, this leads me to believe that you do not give a
ripping flip about what is happening to these vulnerable
children.
Now you answered Senator Cornyn about knowing where the
children are, and knowing who the sponsors are. But I have
talked to caseworkers in some places, and they say they cannot
ask if somebody is in the country legally or not. And OIG said
they had concerns. They had 35 percent--35 percent of the case
files had legibility concerns over images, scans of photo IDs,
birth certificates, legal documents.
So let me ask you this. Can you sit here today in front of
us and say with full certainty that your department knows the
identity of these children's sponsors?
Secretary Becerra. Senator, let me make sure I respond to
the question, in terms of the identity of sponsors. No child in
our custody is released to a sponsor without having gone
through a full vetting. So, certainly we know----
Senator Blackburn. A full vetting where you said let's
speed it up, because Henry Ford could never have been rich and
famous if he worked at the slow process you are. Children are
not widgets on an assembly line. They are human beings.
Secretary Becerra. And that is exactly what I said.
Senator Blackburn. Well, sir, I would say OIG disagrees
with you. He says that you do not know. Do you think you have a
responsibility to follow up with these children when they are
placed?
Secretary Becerra. Senator, we not only believe it is our
responsibility to take care of these children while they are in
our custody; we make efforts, even though you and your
colleagues did not give us the authority, to try to follow them
after they leave our care.
Senator Blackburn. No sir, you have the authority, 6 U.S.C.
279(b).
Secretary Becerra. To do what?
Senator Blackburn. ``ORR, shall be responsible for
coordinating and implementing the care and placement of
unaccompanied alien children.'' That is a ``shall.''
Secretary Becerra. That is correct.
Senator Blackburn. It means you have to do this.
Secretary Becerra. That is the sponsorship and vetting
process.
Senator Blackburn. And then section 2.8.4, ``and care
providers must conduct a safety and well-being follow-up call
with an unaccompanied child and his or her sponsor 30 days
after the release date.'' Mr. Secretary, Director Marcos is
failing in this. There are 85,000 children that we know of that
you all cannot find, and you are hesitant to move forward with
giving us the information.
My time has expired.
Thank you, Mr. Chairman.
The Chairman. I thank my colleague.
Senator Whitehouse?
Secretary Becerra. Mr. Chairman. Mr. Chairman, if I could
just briefly----
The Chairman. Oh, just very briefly.
Secretary Becerra. Very briefly. First, I take umbrage to
the mischaracterization and in some cases misrepresentation of
the facts by Senator Blackburn, and I also want to make it
clear that we have people at ORR who are working as hard as
they can with the resources that we have. Your
misrepresentations on the authorities that we have at ORR are
appalling. It is unfortunate that you wish to mischaracterize
the work that we are doing, and we do everything we can with
the authorities you give us to provide the care that these kids
need. But----
The Chairman. Mr. Secretary, we have to move on with
Senator Whitehouse.
Senator Blackburn. Mr. Chairman, I would ask to submit the
letters and statute for the record.
The Chairman. Without objection, so ordered.
[The letters and statute appear in the appendix beginning
on p. 173.]
The Chairman. Senator Whitehouse?
Senator Whitehouse. Thanks very much, Mr. Chairman. Mr.
Secretary, good to have you here. I want to move to a much more
local issue, a Rhode Island issue.
As you know, from the very earliest beginnings of the
value-based care effort, I have been very, very involved,
helping to set up the Accountable Care Organizations that have
been such a success in Rhode Island and elsewhere, in the
Affordable Care Act, and establishing CMMI, which has largely
been a success, in the Affordable Care Act. And I want to--
actually, Senator Barrasso and I have just launched a bill
today to improve and expand the ACO program.
I first want to thank you all for the AHEAD Model, which
Rhode Island is applying to. The State total-cost-of-care model
provides a very important potential avenue to get off the fee-
for-service treadmill that has served us so badly. So, thank
you for that, and any cooperation and support you can give to
Rhode Island as we pursue that process and come to what I hope
will be a very happy conclusion, I would be very appreciative
of that.
So, CMMI; I have been trying to organize a--CMMI was
designed to be able to try out pilots. That is its core
function, and I have been trying to get a pilot in Rhode Island
to deal with people who are approaching the end of life. And
within that circumstance, the needs change.
So, there are a bunch of waivers--there are five of them
that we have identified that are unhelpful and interfere with
care and humaneness in that phase of life. They may make sense
in the larger world, but at that point they really stop making
sense, and they get in the way of families' ability to take
care of their loved ones.
Today is the third time that I have raised this with you in
hearings, when you have come before us. I do not just raise it
in hearings. We have had repeated meetings with HHS staff. We
have had multiple meetings with the CMS Administrator, and I
have been meeting with CMMI Directors now through three
different administrations. And every time that one leaves, it
is Ground Hog Day, and I have to start all the hell over again
to try to get this moving.
It has now been the better part of a decade, trying to get
a very simple, very easy pilot launched in Rhode Island that
allows from you five waivers that you have given over and over
again in other circumstances. It is not that the waivers are
for some reason unacceptable to CMS or to Medicare or to CMMI
or to anybody else. The waivers have been granted in many
circumstances. What you will not do, or what CMMI will not do,
is to simply say ``yes'' to those five waivers in Rhode Island
for a population that we are very willing to negotiate over.
I would propose that the population be those identified by
ACOs, patients of Accountable Care Organizations who are
nearing the end of life, for whom these waivers will be
appropriate to help the doctors provide better care and save
money. We can talk about others. Federally Qualified Health
Centers could be another great population to work with.
I am open to working with you on what the population should
be, so that CMMI and CMS and you can be comfortable that we
have a manageable pilot that is not going to put the Federal
health-care system at risk. I believe we will prove to you that
you will be improving the humanity of care for people at the
end of life if you let this go forward; that you will be saving
money if you let this go forward; and that, to the extent that
outcomes can be improved for a dying patient, that outcomes and
experience will be better.
So, I am back to you again to say, ``Please help me clear
this logjam.'' This is not a difficult thing, and I do not want
to hear that ``not invented here'' is the reason. I do not want
to be told, ``Well no, we have a different program. Why don't
you go there?''
This is an easy thing that I have pursued for nearly a
decade, asking only for waivers that have already been granted
over and over again, and narrowed to a very simple and
negotiable population in the State of Rhode Island. We have
been waiting for years to get this done, and I really need to
get it done. Yes, you are invited to respond.
Secretary Becerra. Senator, I know how committed you are--
--
Senator Whitehouse. Really briefly would be ``yes.'' That
would be a great answer, one word; we are done, and we can get
to work on fixing this after nearly a decade of obstruction.
Secretary Becerra. Yes. I am rooting for you. Senator, I
know how hard you have been working on this, and in my
conversations with our team at CMMI, they understand the
purpose. They understand all of the different elements of the
proposal. They appreciate the fact that you are willing to be
somewhat flexible on how it is developed.
They continue to raise concerns with the issue of having a
State focus. We are trying to--CMMI is supposed to be an agency
that comes up with models that can then be used nationwide. And
I know that they are trying to move in a direction to make sure
that anything that we do through CMMI--which has very limited
resources, as you know; our authorities are somewhat limited--
that it will be applicable broadly.
And so I am absolutely committed to getting back to you. I
do not think it is as easy as you suggest it is, but I
certainly believe that I owe you at least some conversation, to
see if we can move this.
Senator Whitehouse. Yes. We absolutely do need to move
this.
The Chairman. The time of my colleague has expired.
Next is Senator Hassan.
Colleagues, here is what is going to happen. We have a
number of Senators in the room who want to ask questions.
Senator Cantwell will chair for a few minutes so I can go vote,
but we are just going to keep this going. And at this point, it
is Senator Hassan next, and Senator Cantwell will be chairing,
and we will get everybody in.
Senator Hassan. Well, thank you very much, Chair Wyden. I
want to thank you and the ranking member for this hearing, and
thank you, Mr. Secretary, for being here today. You and I spoke
last week about the cyberattack on Change Healthcare, the
payment processors for hospitals and doctors all across the
country, and the impact that this hack is having in New
Hampshire. And I raised the issue with the President on Monday.
As you and I discussed, this hack is having a really out-
sized impact on small and rural hospitals, including four
Critical Access Hospitals in New Hampshire, which have not
received what amounts to 98 percent of their expected payments
for the last 3 weeks.
After you and I spoke, at least one of our hospitals
received approval for aid from the Medicare program, so thank
you very much for your quick attention. While this has been
some progress, our providers are facing a really long road
ahead.
So this morning, I met with Andrew Witty, the CEO of
UnitedHealth Group, which owns Change Healthcare, and this
meeting followed my approach this week to urge United to step
up and provide more urgent aid to providers. So Mr. Witty and I
had what I would call a constructive conversation this morning.
UnitedHealth Group has made new commitments to provide cash
aid today to the providers in my State who need it, without any
unfair or risky terms. What will HHS's role be in the coming
days to ensure that UnitedHealth Group is following up on these
commitments?
Secretary Becerra. Senator, first, thank you for the work
that you are doing to make sure that not just in New Hampshire,
but generally, that UnitedHealth and other payers step up. As
you probably know, we had a meeting earlier this week with the
payers, with UnitedHealth Group, and providers, and we are now
having a follow-up meeting specifically with the payers on
Friday.
What we are doing is essentially saying to the payers, many
of whom actually have already received their payments from
Medicare and Medicaid--they are holding money, and providers
are not getting paid. We are saying to them, ``You need to
start making payments.''
While you may not receive the actual bill, you have a
general sense on a monthly basis what these providers bill you.
So there is no reason to not work out an advance payment to
these hospitals and other doctors and other providers.
Senator Hassan. Okay. Well, I look forward to continuing to
work with you and your team in making sure United Healthcare
payers generally are doing what they need to do, especially
with our Critical Access Hospitals.
Secretary Becerra. I look forward to working with you.
Senator Hassan. Yes. I want to turn to a different topic
now. I was really pleased that the Department's proposed budget
included $1.6 billion for State Opioid Response grants. These
grants have helped New Hampshire improve its response to the
fentanyl crisis. In the past, you and I have discussed the
program's impact and the importance of continuity of funding
here, so our providers can really plan and really work toward
an overall comprehensive prevention, treatment, and recovery
strategy.
The most recent appropriations language requires HHS to,
and this is a quote, ``avoid a significant cliff'' for any
State when allocating funds from year to year. States have to
have clarity from the administration regarding how the new
funding amounts will be calculated over the next 2 years.
Will you commit to having your staff work with mine to
ensure that this information is clearly communicated to States
as soon as possible?
Secretary Becerra. You absolutely have that commitment.
Senator Hassan. Thank you.
And finally, last week's set of government funding bills
contained multiple provisions to support addiction treatment
for those on Medicaid. One of these bipartisan measures--which
I worked on with Senator Blackburn--permanently requires
Medicaid programs to cover all medications used to treat opioid
use disorder, a requirement that was set to expire next year.
The funding bill also included bipartisan legislation--
which I worked on with Senators Thune and Blackburn--to expand
access to short-term residential addiction treatment under
Medicaid. Mr. Secretary, can you discuss how these provisions,
now signed into law, will be supported and expanded upon by the
program in the President's budget?
Secretary Becerra. Senator--and first, thank you very much
for your commitment to this issue, and for being so dogged in
pursuing real results for folks. We are going to try to make
sure we are partnering with States and local communities to
make sure that they are aware that Medicaid can actually now be
more helpful.
We have to wait to see how they structure their programs,
because they are the ones that operate them. But we want States
to know that Medicaid wants to be in the game.
Senator Hassan. Okay. Thank you very much, and I yield my
time, Madam Chair.
Senator Cantwell [presiding]. Thank you.
Senator Young?
Senator Young. Thank you, Madam Chair. Mr. Becerra,
welcome. It is good to see you again.
Mr. Secretary, HHS can and must play a critical role in
advancing access to innovative medical technologies. I know you
agree. But the reality today is that many medical technologies
authorized by the FDA face significant barriers in securing
Medicare coverage. This prevents patient access to key medical
innovations.
I am encouraged by CMS's work last year on releasing the
long-awaited proposal, Transitional Coverage for Emerging
Technologies, or TCET. This would establish criteria for an
expedited coverage pathway to provide Medicare beneficiaries
with faster access to innovative and beneficial technologies.
We are now waiting on a final TCET notice, which we thought
would be finalized by the end of last year. I, along with a
number of my Senate colleagues, sent a letter to CMS asking for
TCET to be finalized as soon as possible, so that patients do
not have to continue experiencing delays and barriers in
accessing innovative and often lifesaving medical technologies.
Secretary Becerra, given that roughly 7 months has passed
since the TCET comment period ended, can you assure us that CMS
will issue the final TCET policy this spring or early summer?
Secretary Becerra. Senator, thank you for the question, and
for the work you have done on this particular issue. And by the
way, I hope that we continue to work on this, because we are
talking about the new frontier when it comes to medicine. So we
are trying to make sure we do it the right way. Obviously,
there are many eyes that are placed on these new proposals.
What I can commit to you is to make sure that we get this
out as quickly as we can. We have to get it right, because we
want to make sure people have access to the medicines.
Senator Young. When do you estimate--surely you have an
estimate of the time period, right? Would spring be realistic
or early summer?
Secretary Becerra. Senator, honestly, I wish I could say
``yes,'' but I want to be honest with you that the process does
not move always as quickly as one would expect. Again, this is
not dealing with something we--you know, a movie. This is not a
movie we have seen over and over again. This is new stuff. We
have to get it right.
Senator Young. What is--for those who are watching and care
a lot about this issue, which is many of my constituents--what
is the holdup, so to speak? Why is this taking longer than
maybe they had expected, because business people and the
innovators require certainty, and what are you doing to try and
manage some of those dynamics?
Secretary Becerra. First, we have to make sure that
whatever we propose fits within the statutory prescriptions you
gave us. So, we cannot go outside of it, and we do not want to
be so narrow that it does not do everything you are asking us
to do. And that, that takes a lot, because sometimes you all
give us specificity in the legislation; sometimes it leaves it
somewhat open, and we have to interpret.
Second, we have to make sure that everything we do at the
end of the day will be done in the interest of the patients who
will be receiving the medications and therapies.
Finally, we have to make sure that whatever we do, we have
to be able to look around the corner, to make sure that what we
are doing is not impacting something else, where we might end
up in court and everything gets delayed because we are in
court.
Senator Young. Thank you. So, stepping back, how does HHS
plan to address a broader, at least perceived disconnect
between the pace of innovation and outdated pathways? I think
that is always a dynamic that we are going to be dealing with
to some extent, but closing that window will save lives and
improve lives immeasurably. So what are your thoughts on that?
Secretary Becerra. Yes, and remember--as you know, we are
working with two different standards that really are at play
here. FDA has a standard: before a drug can hit the market, FDA
has to say it is safe and it is effective. Then you have a
different standard with Medicare, and CMS has to make a
determination, not of ``safe and effective,'' but of
``reasonable and necessary,'' two different standards.
And so, a drug gets out because FDA says it is safe and
effective; that does not automatically mean Medicare covers it.
Senator Young. So, you struck on sort of the inherent
challenge that we are going to be dealing with probably on a
going forward basis, unless we change the standard statutorily.
But from a management perspective, how are you trying to
minimize that delay?
Secretary Becerra. And that is where we get into the rules
and why have they not come out as quickly as you would like,
because we have to make sure we are not overstepping our
bounds.
Senator Young. Okay.
Secretary Becerra. And we could use your help, because the
more you all direct us, the faster we can move.
Senator Young. If you have thoughts on how we can do that--
because you have an army of internal experts, surely they have
some ideas about how we might consider optimizing the process.
I would welcome this.
Secretary Becerra. I will take up the invitation.
Senator Young. Okay; fantastic. Well, I will look forward
to working with you on that.
And as I come to the end of my time, I will just ask you.
There are patient listening sessions--I could itemize some of
the challenges--this is associated with the Inflation Reduction
Act. CMS held a number of patient listening sessions.
It would not surprise me if you anticipated a question
about this in your hearing. Suffice it to say that they were
not perceived by participants to have been particularly
helpful. In fact, they created the impression, because of their
design, that they were not intended to really gather a lot of
information.
So, what are your plans to improve the process so that
patient concerns with the IRA changes are fully heard and
addressed?
Secretary Becerra. Senator, I will again offer to take your
guidance. If you know of any particular concerns that are being
raised, we would love to hear them.
Senator Young. I will submit them to you. There is an
itemization. Time does not permit me the ability to unpack
about 10 concerns.
Secretary Becerra. Okay. And we try to reach out, but our
funds are limited on doing that type of outreach. Most of our
money has to be spent on actually doing something. But we are
always looking for ways to try to get feedback from patients.
Senator Young. Thank you, Mr. Secretary.
Senator Cantwell. Thank you, Senator.
Senator Tillis?
Senator Tillis. Thank you, Senator. Mr. Becerra, thank you
for being here.
I want to get some housekeeping out of the way. I am going
to resubmit some questions for the record in this hearing that
I submitted back in November to Director Marcos, and I really
would like to get a prompt response on today's questions. I am
not going to go through them now.
They have to do largely with the facility down in
Greensboro, that I do not think I will have time to talk about
today. But I have a big concern with the timeliness of it. And
I have been in and out because I have tried to get in the order
here, but you can see how people come in and out.
But this is beautiful. Nobody's behind me, so I may even be
able to ask----
Secretary Becerra. I remember those days----
Senator Tillis [continuing]. Extra questions. But yes.
Actually, that is one thing I was going to mention. I have
spoken with a number of people who have served with you, and
they have great things to say about you. I know some of the
bipartisan work that you have worked on.
But I do feel like there have been some partisan decisions
that you are more or less responsible for implementing that I
have a concern with, and I am going to point to drug pricing or
price controls in the IRA as one of them.
No question that we can look at that and say that we
saved--I think that you mentioned $100 billion. Is that what
you mentioned in response?
Secretary Becerra. That's true.
Senator Tillis. But what have we lost? I know that shortly
after the IRA was implemented, there was at least one call that
was shared with us, that showed a double-digit drop in small
molecule research, because it has to come from somewhere.
And so, I would be interested if you could maybe submit for
the record--unless you have detailed information now--data that
would refute the fact that if you take down--I worked in
research and development; not in pharmaceuticals, in high-tech.
Margin has to come from somewhere. The money has to come
from somewhere, and if you reduce the potential to get
compensated for your product, then you just have less money to
spend on R&D. It looks like there is a direct correlation to
the IRA's price controls and a big dip in small molecule
research. If you have any information to refute that, I would
like to see it.
We have to get smarter with how we try and drive down drug
pricing, because you mentioned in response to someone else that
we want to bring manufacturing back home. If you squeeze the
margins for a pharmaceutical manufacturer--and we have a lot in
North Carolina--then you produce fewer resources to make the
case to bring manufacturing home, when we know we are in a more
expensive jurisdiction.
So all of these things are interrelated. You cannot, on the
one hand, whack this industry and lower prices and then try to
get this industry, which has a fiduciary responsibility to
their shareholders, to come manufacture at home.
Now, maybe we can get them out of China, but we are not
creating a hospitable environment in the United States for them
to make these business decisions if we continue to whack them,
not to mention that the President, through TRIPS waivers, is
even making it more chilling on the pharmaceutical industry in
terms of actually being able to defend their intellectual
property rights over a period of time to recover the cost of an
investment they made in a drug.
If we do not figure out a bipartisan way to deal with this,
I will guarantee you, we can have people thrilled about winning
the battle, but we are going to lose the war. And when we talk
about drug pricing, the last time I checked, a therapy or a
drug that was never brought to market costs zero, but so do the
human consequences.
So I am going to give that soap box speech, because as you
said to Senator Barrasso, there is a lot packed in there. We
have to get to the right way to do it, and this is a very
dangerous game that we are playing, of just making purely
partisan progress on this issue, like arguably the IRA was.
There was not a single Republican vote.
I also wanted to cover--one of the advantages of being this
far down on the dais is, you get to hear a lot of other people
talk. It is another thing that I think we will probably meet
with you about separately.
Number one, we have got to get telehealth permanently
authorized, period. Anybody who is just asking for another
extension does not know how the free market works. The free
market works this way. I know that this is the new operating
standard from the perspective of the Federal Government, and I
also know that there are State impediments that we need to work
on. I am doing my part in North Carolina.
But you are not going to get, you are not going to
stimulate investment and innovation in telehealth unless they
know it is permanent. Businesses do not operate on 2-year
horizons, and it has been stress-tested. All of the naysayers
about telehealth before COVID have been proven wrong.
It works. It works at scale. Its efficacy is indisputable.
So we need to collectively work on the Federal layer, and then
put pressure on the State layer. I have told my colleagues not
to come to me in this State and tell me telehealth is good,
except for a couple of professions, or except across certain
territories. It is irrational, and I reject it before you even
walk in my door.
But we need some leadership from the administration--I
think from you--to get it done right. And I will submit other
questions for the record. Thank you.
The Chairman. The time of my colleague has expired. We are
going to go right to Senator Cantwell here in a minute. But
just coming back, I heard my friend--and we have done a lot of
work together--talking about manufacturing and bringing it back
from overseas if we have bipartisan approaches in terms of
issues like R&D.
I will tell you later if I can catch you, I know of such an
example. It got 357 votes in the House of Representatives. And
kidding aside, I want to work with my colleague.
Senator Cantwell?
Senator Cantwell. Thank you, Mr. Chairman. Secretary
Becerra, good to see you. Thank you so much for your leadership
on many fronts.
I wanted to talk about the fentanyl crisis, which has
claimed 1,000 people who died in King County, WA in 2023 from
an overdose, and we have seen a 425-percent increase in
fentanyl-related overdoses from 2020 to 2022, so we are very
impacted.
One of the things that researchers--we have had lots of
roundtables on this, and I know the President proposed $700
million in substance abuse disorder and mental health
treatment, so thank you for that. One of the innovations that
has been discussed by Dr. Caleb Banta-Green at the University
of Washington is having, basically, health engagement hubs. You
could either do this by building capacity at existing health
clinics, or you could build hubs that would be available for
treatment. Obviously, when we have held our roundtables around
the State, the one thing that is really clear is, not enough
beds.
And again, then you have all sorts of problems of when you
can get people back into treatment. But if you had engagement
hubs that were clinics based in big geographic locations,
people could access daily the kind of treatments that they
needed, and that would help us in addressing this issue.
We have also heard from law enforcement how mobile units
could be used in rural areas in helping jurisdictions. So the
long and the short of it is, I would assume that you think
these are good ideas and innovations, and we want to get CMS's
help in some technical assistance on this legislation.
We have had it over with your shop since January, and we
want to get some technical assistance. Could you help us speed
up this process?
Secretary Becerra. We are on board.
Senator Cantwell. Thank you; thank you. Critically,
critically important.
I wanted to also ask about the basic health plan, which as
you know, you and I have talked about many times. But I believe
that it is a very successful program where it exists.
My understanding is that Oregon is rolling this out this
summer, so they are finalizing the insurance providers. But are
we not seeing how this is driving down the cost of premiums and
out-of-
pocket expenses, and helping the government, because it is
driving more savings for us as well?
I think in the New York BHP program, enrollees are paying
zero--well, they are paying a reduced premium, and I think they
are up to a million beneficiaries in the program. So could you
speak to why you think we should continue to expand from New
York and Minnesota and Oregon?
Secretary Becerra. Senator, I know this has been a program
that has worked well in your State, and I know that other
States are looking to adopt it. We are interested in having
States innovate. We want to be supportive. We have been
granting quite a few waiver authorities within the Medicaid
program.
What we are interested in is seeing how States test these
different operations. We would love to see any number of States
take action to try to do what your State, Washington, is doing,
what Oregon has done, because we think there are real cost
savings that could be had, and we would love to be able to let
the State keep some of those cost savings as we save some money
at the Federal level, through the various Federal programs that
we have: Medicare, Medicaid, and so forth.
Senator Cantwell. Well, I think it is time. I think, Mr.
Chairman--you know, we went through the pandemic, and I think
the challenges of the exchange may have gotten buried in the
capacity to just deal with the pandemic. But I think it is
incumbent on us now to look back at where the exchange has been
in driving down cost, and where bundling of lower-end above-
the-Medicaid-rate customers to drive a bargain for them in
premiums is winning the day, or at least allowing for those who
are not insured to get better insurance at a cheaper rate.
And also, we obviously know here, we have our own financial
challenges in doing--you know, why pay for an expensive silver
plan? Why use Federal tax dollars to pay for an expensive
silver plan, when you can bundle up a population above the
Medicaid rate, just like when you buy in bulk at Costco and you
get a discount.
So I think it is time, given all our financial priorities
here, to pay more attention to those States that have
implemented. And just to be clear, our State did, was the first
BHP before the Affordable Care Act. So, we are not one of the
States that have currently successfully moved forward on this,
but I am hoping that we will in the near future.
Thank you, Mr. Chairman.
The Chairman. I thank my colleague from the Pacific
Northwest. Whenever you hear Senator Cantwell talk about health
care, you often come away saying, ``This may be too logical for
Washington, DC.'' But the fact is that dollar for dollar, the
concepts that Senator Cantwell has been talking about for years
in terms of the Washington basic health plan, the concepts and
coordinating services and the nuts and bolts of rewarding
prevention and all this, I am very pleased that once again the
Northwest, not just Washington State, is coming around and
getting the message out. I look forward to working with her on
this and many fronts.
Senator Cantwell. Thank you.
The Chairman. Senator Warren?
Senator Warren. Thank you, Mr. Chairman.
So, President Biden is working to lower drug prices for
Americans, and now for the first time, look at the list.
Medicare can negotiate the price of prescription drugs; drug
companies face penalties when they hike prices above inflation;
insulin copays are capped at $35 for seniors and people with
disabilities; and all out-of-pocket costs for prescription
drugs will be capped at $2,000 for Medicare beneficiaries
beginning next year.
Now, President Biden wants to double down on this progress
by ensuring that people who don't have Medicare feel the same
relief, and I am all for it. There is no reason why Americans
should have to pay more for prescription drugs than anywhere
else in the world, especially when American taxpayers
contribute billions of dollars to the research and development
for those same drugs.
Secretary Becerra, do you know how much American taxpayers
invest in medical research and development every year, drug
research and development?
Secretary Becerra. Senator, I hope you have that number. I
know it's a big amount, but I can get it to you if you do not
have it.
Senator Warren. That's okay; I actually do have it. It's
about $115 billion, of which $54 billion is for biomedical
research. That's in a single year, and I think this money is
well spent. I'm a big fan. It supports the scientific research
that we need to develop new therapies and new cures.
But the problem is that big pharma takes these discoveries,
turns them into drugs that they can market, and then charges
Americans nearly triple what they charge other nations to
access the very same drugs that American taxpayers helped
develop.
So, Secretary Becerra, do you think that Americans should
have to pay more for drugs that their tax dollars help develop
than other people around the world?
Secretary Becerra. Senator, first, in the spirit of
competition, we should be able to get prices that everyone else
gets. But second, if we put some skin in the game, we should
probably be able to get far better pricing.
Senator Warren. I like your approach on this. You know,
charging Americans this much for drugs when we're the ones who
help pay to develop those drugs is just greed, pure and simple,
and the Biden administration wants to do something about it. So
in December, it released a proposal that would allow more
companies to produce a drug that taxpayers help develop, if the
original drug manufacturer jacked up the price so much that
people can't afford it. As you know, this is called ``march-in
rights,'' and it would inject some competition into the market
and lower drug prices for families.
Now, this law has been on the books for over 40 years, but
it has never, never been used, in large part because big pharma
has spent millions of dollars trying to convince policymakers
that a drug's price has no impact on whether or not patients
can access it. But I have to say, any person who is forced to
make difficult decisions between affording their medication and
paying rent or trying to put food on the table will tell you
that argument is wrong, that if you can't afford to buy the
drug, then you don't have access to it.
So, Secretary Becerra, if this draft framework that the
Biden administration is working on right now is finalized, what
impact would that have for American families?
Secretary Becerra. Senator, our belief is that this would
make the pharmaceutical industry far more competitive. It would
also prevent the lockout of manufacturers who are willing to
actually sell for competitive prices, and it would probably
unlock access to some very crucial medications for more
Americans.
And so, on the whole, I think what we're trying to do is
fulfill the character of this Nation, to have competition drive
what people get.
Senator Warren. All right. I like this, and I very much
appreciate your work on this. In February, I sent a letter with
over 70 of my colleagues in the House and the Senate, urging
the administration to strengthen and to quickly finalize this
proposal that would have the benefits that you describe.
It would stop big pharma's price gouging and ensure that
Americans can access the lifesaving drugs that their tax
dollars help discover. So please, get this done as quickly and
effectively as you can.
Secretary Becerra. We will try.
Senator Warren. Good. Thank you, Mr. Chairman.
The Chairman. I thank my colleague.
Mr. Secretary, it has been a long morning, but I have a
couple of areas that I just need to clean up with you. One, as
you know, our colleague from Oklahoma, Senator Lankford, was
talking about women using dangerous chemicals for abortion.
That was essentially the topic of his conversation, and I think
he left most people kind of confused about what he was talking
about.
I just want to ask you--and Senator Warren's been a great
advocate for women in these areas as well--about what this is
really all about. This topic is all about the safe, effective
alternative to surgical abortion, and whether or not this
medicine--which is now responsible for more than 50 percent of
the abortions in this country--is going to be available.
That is what the court case is really all about. It stems
from, of course, the overturning of Roe v. Wade. We are already
seeing the consequences of that ruling playing out nationwide,
with women being denied the health care they need and deserve.
And if, and I emphasize if the antiabortion activists get
their way with mifepristone--which is, as I said, currently
before the court--it would effectively be a nationwide abortion
ban. Now, you and I served together in the other body, the
House of Representatives, and quite some time I think before
you came, I chaired the first congressional hearing on what
came to be mifepristone. This was back in 1990.
The issue that we focused on then is still the issue of
today, and that is, are these decisions going to be made on the
basis of science, or are they going to be made on the basis of
politics? And I started arguing in that first hearing, I
believe it was 1990, that we ought to make the decisions on the
basis of science.
The Food and Drug Administration was activated. It has now
been available for years and years, with evidence showing that
it is as safe as Tylenol. I just wanted to kind of set the
record straight, because what Senator Lankford was talking
about with dangerous chemicals and the like, is contradicted by
a lengthy set of data sets developed by the Food and Drug
Administration.
And I wanted to ask you a question or two on this. If
access to mifepristone is rolled back--which is what may happen
with this court decision--what would that do to access to
health care for women all over the country, in red and blue
States?
You know, there was all this discussion about how the
States would basically be able to proceed in their own kind of
fashion. Now we have seen, with respect to mifepristone, if the
antiabortion activists get their way, they could put
restrictions or completely make it impossible to get access to
the drug at all in every corner of the United States.
But I would like to have the Secretary of Health and Human
Services--since we had Senator Lankford, my colleague, talking
about it--give me your assessment about what a Federal ban via
the courts would do to access to a safe, effective alternative
to surgical abortion.
Secretary Becerra. Mr. Chairman, well, first I think it is
important that when you say ``safe and effective,'' you are not
just saying that because you believe it. It is because the
science has shown that mifepristone, for more than 2 decades,
has not only been safe but it has been effective.
If mifepristone were to be lost to Americans who need it as
medication, it would further reduce access to care. My
daughters, who today have fewer rights to access health care
than their mother had, would lose even further access to the
care that they need.
It would also mean that more women would probably place
themselves in further danger, trying to access the care that
they need, which would likely lead us to the scenarios that
were very common pre-Roe, before 1973, where women would die,
women would end up having life consequences, as a result of
some of the surgeries or actions that were taken, medical
actions that were taken, and it puts us in a place where we
have regressed.
But I think, Mr. Chairman, the point that too often is
missed is just not mifepristone. Mifepristone went through a
process within the FDA to be found safe and effective. Many
other drugs, many other medications that Americans rely on,
went through essentially the same process of analysis.
If the analysis that was done with mifepristone were to be
overturned, it would be very difficult for anyone to conceive
that the only result is that mifepristone is taken off of the
market. And access to consumers--because there are so many
other drugs that went through the same process--that would then
be subject perhaps to the same legal challenges on their
accessibility throughout America for Americans.
The Chairman. It is an important point to make, and it is
exactly the point that we made more than 30 years ago. I
remember in a drafty House Small Business room, where I was
chairing this hearing, we said the second you decide to start
making these decisions on the basis of politics rather than
science--and we are talking about how the FDA spent literally
decades working through the scientific issues with respect to
the safety of mifepristone--we are going back to the Wild West.
I mean, you are going back to the days when basically
politics and who has the political strength is going to drive
decisions that I think the American people, by an overwhelming
majority, want to have made through scientists and other
policymakers who are not about Ds and Rs, but they are about
good science.
I appreciate your bringing this up, and I am continually
struck by how the issues we had to wrestle with more than 30
years ago, putting science above politics, are exactly what the
challenge is now with respect to mifepristone.
Let me ask you about the Office of Refugee Resettlement,
where we heard lots of back and forth and charges leveled
against you, and you know, this is an office that works with
unaccompanied children. That is their responsibility, and for
years and years and years, these were the kids put in cages.
The Trump administration, as far as I can tell, even lost
track of them, lost track of where they were. And my
understanding is, the Office of Refugee Resettlement, under
several statutes, is now working to improve the safeguards for
these kids. And as we wrap up, that seems to be a mission that
ought to get the support of Democrats and Republicans. Your
thoughts?
Secretary Becerra. It actually should, and as I tried to
explain, when Congress passed the laws for placing children who
did not have an adult with them who came from the border, our
responsibility under the statutes that Congress passed was to
provide the temporary care of these children until they were
placed with a vetted sponsor.
Once we place that child with a vetted sponsor, our
authorities over that child end. That child does not need to
communicate with us. The sponsor does not need to communicate
with us. So, we do everything we can, including after we
discharge the child, to try to follow up, even though there is
no requirement that the child or the sponsor get back to us.
We do try to do follow-up to make sure that everything is
moving the right way with that sponsorship. And what we are
doing is working with the Department of Labor, because they are
the ones that track any labor violations that might occur,
especially with child labor.
We are trying to work with them to make sure that we let
them know what we know about any kids, in the event that some
of these children who might be trafficked or used for
exploitive child labor are among those who were at one point
under our custody.
But we are trying to do everything we can, with the
authorities and the resources Congress gives us, to provide the
care that you would expect for any child to receive. We do not
deal with the immigration circumstance of the child. That is
done by the Department of Homeland Security.
We deal with the care under law, as we are required, to
make sure that the children are receiving the care that any
child in this country should receive.
The Chairman. So I guess, about 3 hours ago, what I did is
tried to take the exact quotes from former President Trump, who
claimed that he was going to do so much to lower medicine
costs, and he was going to take on big pharma, and he was going
to be for more competition.
And then I compared it to the record, which showed none of
that. I contrasted it with President Biden and President
Biden's conversation with me, and I am sure plenty of other
people, shortly after the 2020 election. And we talked about
getting rid of big pharma's holy grail, where they could just
stop any negotiations, and we talked about price gouging, and
we talked about out-of-pocket caps.
And I remember walking off the floor of the U.S. Senate in
2022, late in the summer, and I said, ``We actually did it.
This is not a debatable proposition. We passed this law. The
President of the United States is going to sign it.'' And I
just think it is important, as we wrap up, to make clear that
there are differences as deep as Crater Lake, as I said 3 hours
ago.
And what the differences are about is values, and the
previous administration was sympathetic to the corporate
interests, and those corporate interests were driving up
health-care costs, particularly big pharma. And what President
Biden said, and what I support as our North Star, is getting a
fair shake for people without power and without clout, and all
those seniors you know.
We now have been able--your people got it to us. Nine
million Americans, one out of every seven seniors, are going to
benefit in Medicare from the fact that we are negotiating,
working to get a fair shake.
So you took a lot of hits this morning. I guess that goes
with the turf, but I want you to know I think that what you are
doing and the values that support these actions are what the
American people want. I look forward to working with you
closely in the days ahead.
And for Senators, questions for the record are due next
Thursday the 21st, at 5 p.m.
Mr. Secretary, I look forward to talking to you soon.
With that, the Finance Committee is adjourned.
[Whereupon, at 12:52 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) 2025 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.
When President Biden took office, the number of Americans with
health insurance was declining. We changed that. Over 300 million
Americans now have health insurance--the most under any other
administration.
Until now, Americans paying far too much for prescription drugs
haven't had any relief. We changed that. The Inflation Reduction Act,
signed into law by President Biden in 2022, caps the price of insulin
at $35 per month per insulin prescription for people with Medicare, and
certain important vaccines, like the shingles vaccine, are available
for free. And now, for the first time, HHS is negotiating directly with
drug companies to lower prescription drug costs for people with
Medicare, and we're working to make health-care markets more
competitive across the board.
The Biden-Harris administration has taken decisive action to
protect access to reproductive health care, including abortion and
contraception care. We are also fighting tooth and nail to stop the
dismantling of the remaining rights and freedoms available to women
across the country.
In 3 years, the Biden-Harris administration has made the largest
investment in behavioral health, which includes both substance use and
mental health, in a generation. We are on the path to increasing the
number of mental health counselors in schools, have improved support
services for high-risk and underserved populations, and trained health-
care providers, families, and school personnel on best practices for
supporting young people with behavioral health needs, including those
taking medications to treat opioid use disorder.
There are many, many more accomplishments that I could highlight--
but, there is more work to be done. It is critical that we look forward
to the challenges that lie ahead and take the actions that will ensure
that we can continue to improve the health and well-being of all
Americans.
This budget lays out a vision for a Nation that fosters innovation,
invests in health, and supports its most vulnerable.
HHS remains at the center of some of the most important issues for
American families--including expanding access to care and lowering
health-care costs; protecting and strengthening Medicare, Medicaid, and
the Marketplace; helping ensure access to reproductive health care;
improving maternal health care; transforming the way we deliver
behavioral health care, particularly for substance use disorders;
improving care for older adults and people with disabilities; preparing
for future public health threats; ending cancer as we know it; and
ensuring access to high-quality education and support for children.
We also must continue to advance cutting-edge research, and meet
the health needs of Tribal Nations and Native communities. And none of
this would be possible without the resources to support our operations.
All told, the FY 2025 budget proposes $130.7 billion in
discretionary and $1.7 trillion dollars in mandatory funding to advance
our mission and invest in key priorities that will impact the lives of
all Americans. We remain steadfast in our commitment to be good
stewards of taxpayer dollars, and to continually improving the
experience of the people whom our programs serve.
expanding coverage and lowering health-care costs
Once again, a record-breaking number of Americans enrolled in the
health insurance marketplace in 2024--over 21.3 million people. That
means more Americans are getting the health-care coverage they need at
an affordable cost. This is a testament to the success of the
Affordable Care Act.
The FY 2025 budget continues to build on this success by making
permanent the expanded premium tax credits that the Inflation Reduction
Act extended and providing Medicaid-like coverage to low-income
individuals in States that have not expanded Medicaid under the
Affordable Care Act, along with financial incentives to ensure States
maintain their existing expansions. For Medicaid and CHIP, the budget
allows States to extend the existing 12-month continuous eligibility
for all children to 36 months, and allows States to provide continuous
eligibility for children from birth until they turn age 6. Further, the
budget prohibits enrollment fees and premiums in CHIP. It extends
consumer surprise billing protections to ground ambulances, building on
the No Surprises Act. The budget also advances the steps taken in the
Inflation Reduction Act to improve access to affordable prescription
drugs by further expanding Medicare's ability to negotiate prices
directly with drug manufacturers, and expanding inflation rebates and
the $2,000 out-of-pocket prescription drug cost cap beyond Medicare and
into the commercial market.
Fundamental to our vision of affordable, accessible health care is
ensuring Americans can rely on Medicare for generations to come. The FY
2025 budget proposes changes that indefinitely extends the solvency of
the Medicare Hospital Insurance trust fund.
In addition, the budget continues on the path to doubling Health
Center Program funding, which provides health-care services to millions
of Americans, particularly those in underserved communities. The budget
provides $8.2 billion for Health Centers in 2025, allowing the program
to serve approximately 3.9 million additional patients. This investment
also supports the expansion of behavioral health services at Health
Centers.
transforming behavioral health
The FY 2025 budget proposes over $20.8 billion in investments to
improve behavioral health across the Department. This includes $602
million, an additional $100 million, to the 988 Suicide and Crisis
Lifeline for an expanded awareness campaign and increased technical
assistance support and infrastructure. This investment in 988 also
maintains specialized services for LGBTQI+ youth, Spanish speakers, and
the deaf and hard of hearing community.
The budget seeks to expand access to high-quality mental health
care, including through a $1 billion investment in the Community Mental
Health Services Block Grant. The budget also improves behavioral health
benefits for people with Medicare and Medicaid and in the private
insurance market, with an emphasis on improving access, promoting
equity, and fostering innovation. In addition, the budget invests $1
billion in health information technology adoption for inpatient
psychiatric facilities, as well as certain outpatient and residential
behavioral health facilities. If we are serious about integrating
behavioral health providers into the rest of the health-care system, we
must close the technology gap and advance better information exchange
with other health-care, public health, and community partners.
The budget also addresses the sobering impact of the behavioral
health crisis on our Nation's youth. National surveys of youth have
shown significant increases in certain mental health symptoms,
including depressive symptoms and suicidal ideation, compounded by the
effects of the COVID-19 pandemic. The surveys underscore the urgency
and importance of our commitment to equip our youth with the tools they
desperately need to address these unique challenges. The budget expands
mental health services in schools and bolsters youth mental health
programs by investing an additional $50 million in Project AWARE
(Advancing Wellness and Resiliency in Education) and an additional $50
million in children's mental health services. These programs provide
services to States, Tribes, and communities to support children with
serious emotional challenges and their families. The budget also
includes $30 million for the Centers for Disease Control and
Prevention's (CDC) Essentials for Childhood: Preventing Adverse
Childhood Experiences (ACEs) through Data to Action program, which will
increase the number of States, territories, localities, and Tribes
implementing ACEs prevention strategies and approaches in their
communities.
In addition, the budget increases funding to States for overdose
prevention and substance use disorders treatment. In January 2021, the
overdose death rate was increasing 31 percent year over year. Today,
the rate of increase has dropped to about 2 percent year over year.
We're making great progress, but in the face of an increasingly
dangerous drug supply, we need to do more. The budget provides an
additional $20 million for the State Opioid Response program, which has
provided treatment services to over 1.2 million people and has helped
States to reverse more than 500,000 overdoses. It also includes a $5-
million increase for the Tribal Opioid Response program to address the
disproportionate impact of the overdose crisis on American Indian and
Alaska Native people.
The FY 2025 budget also continues to invest in growing and
diversifying the behavioral health workforce. The budget includes $254
million for the Health Resources and Services Administration (HRSA) for
Behavioral Health Workforce Development programs, including expanding
the substance use disorder provider workforce. The budget also
continues to expand key HRSA programs by providing $916 million for the
National Health Service Corps and $320 million for Teaching Health
Centers Graduate Medical Education programs in 2025 to ensure the
continued growth of health-care services and expand workforce capacity
across the country, including for behavioral health. The budget also
includes $20 million for the Substance Abuse and Mental Health Services
Administration's (SAMHSA's) Minority Fellowship Programs to reduce
health disparities and improve behavioral health-care outcomes for
underserved populations.
improving the well-being of children, families, and older adults
The FY 2025 budget invests in the future of our Nation's children
through high-quality early childhood education. The budget proposes to
guarantee affordable child care to low- and middle-income working
families from birth until kindergarten and offer preschool to all 4-
year-olds, making early care and education programs affordable and
available where families live and work, and increasing wages for early
childhood education workers. Under this proposal, preschool would be
free and the average family would pay no more than $10 per day for
child care until their child starts kindergarten, saving them over $600
per child, per month. This proposal will go a long way to support our
most vulnerable children and their families.
The budget continues to bolster Head Start for children from birth
to age 5 and provides an additional $544 million for the Head Start
workforce, allowing wages to keep pace with inflation and for us to
maintain a high-quality child-care workforce. As child care continues
to be unaffordable or unavailable for millions of Americans, the budget
provides funding to Americans that desperately need it to continue to
work and support their families. It also provides an additional $500
million for the Child Care and Development Block Grant to continue our
progress in stabilizing the child-care sector and helping more
Americans afford child care.
The budget also invests in child welfare, with a package totaling
$11.4 billion over 10 years. This funding expands services and supports
to families at risk of child maltreatment or involvement with the child
welfare system, increases funding for prevention services and kinship
placements and supports for older youth, and increases and streamlines
funding to Tribes.
Finally, we are also investing in supports for older adults and
people with disabilities to ensure they can participate fully in our
communities. The FY 2025 budget provides $2.7 billion for
Administration for Community Living programs--a $70-
million increase above the 2023 enacted level. This includes additional
funds for nutrition programs, as well as funding for suicide prevention
for older adults.
enhancing long-term care in all settings
HHS programs support the health and well-being of people with
disabilities and older adults. The FY 2025 budget includes a 10-year,
$150-billion proposal to expand Medicaid home and community-based
services to allow more older adults and people with disabilities to
receive care at home and in their communities. Recognizing that a
strong, well-trained workforce is essential to delivering high-quality
services, the budget initiative is designed to enhance the quality of
these jobs. When older adults' support needs become so great that they
must enter nursing homes, they deserve safe, high-quality long-term
care. At the 2024 CR level, State survey agencies would complete just
65 percent of statutorily required nursing home surveys in FY 2024,
down from 100 percent in FY 2022 and 75 percent in FY 2023. To address
the increasing workloads and align with the administration's
commitments to improve the safety and quality of nursing home care, the
budget requests an increase in funding to allow CMS to conduct 85
percent of the mandatory surveys, as well as legislative proposals that
strengthen quality and care in long-term care facilities for FY 2025.
In addition, the administration's proposal to shift survey and
certification funding for nursing home facilities from discretionary to
mandatory and increase that funding to conduct 100 percent of mandatory
surveys, effective in FY 2026, would allow for sustained and reliable
oversight and enforcement in the Nation's nursing homes and ensure that
Americans receive high-quality, safe services within these facilities.
strengthening maternal health outcomes
and reproductive health-care access
The budget reflects the administration's commitment to address the
U.S. maternal mortality rate, which is higher than all other developed
nations and on the rise. The majority of these deaths are preventable,
and Black and American Indian and Alaska Native women are
disproportionately affected. Across HHS, the budget invests in tackling
this maternal health crisis, including $376 million focused on
addressing maternal mortality and maternal health equity. This includes
targeted funding within the Indian Health Service (IHS) to provide
culturally relevant maternal health care in Indian Country, additional
funding for CDC to expand maternal mortality prevention, and continued
support for the Implementing a Maternal health and PRegnancy Outcomes
Vision for Everyone (IMPROVE) initiative in the National Institutes of
Health (NIH). It also includes $215 million in HRSA specifically for
reducing maternal mortality and morbidity. This funding will improve
access to pre- and postnatal care, including for behavioral health,
provide access to emergency care services, expand maternal care in
rural and underserved communities, and more.
To help improve maternal health coverage and prioritize person-
centered care, the budget also includes an optional Medicaid benefit
that expands coverage of maternal health support services across the
prenatal, labor and delivery, and postpartum periods, with enhanced
Federal funding available for the first 5 years in which States take up
the State Medicaid option. This includes coverage for a range of
maternal health support workers, including doulas. With this benefit,
we aim to bolster maternal health supports throughout the entire
continuum of care and to demonstrate our dedication to supporting women
at every stage of pregnancy and beyond.
Access to reproductive health care, including contraception, is a
more urgent issue now than it has been in decades. The budget provides
$390 million, a 36-percent increase, to the title X family planning
program to meet the increased need for family planning services, which
are essential to ensuring women have control over personal decisions
about their own health, lives, and families. Title X remains the only
Federal grant program dedicated solely to providing individuals with
comprehensive family planning services in communities across the United
States.
preparing for future public health threats
While this administration has made tremendous strides in
preparedness capabilities since the pandemic, there are many public
health threats beyond COVID-19. The budget therefore includes over
$28.9 billion in total resources across the Department to support
preparedness, including efforts to prevent future pandemics, in
addition to response capabilities, consistent with the President's plan
to prepare for and respond to biological threats, as outlined in the
2022 National Biodefense Strategy and Implementation Plan.
This includes $8.9 billion in discretionary funding for
preparedness across the Department. The budget invests an additional
$38 million for CDC to manage the Response Ready Enterprise Data
Integration platform, and an additional $20 million for the Biomedical
Advanced Research and Development Authority to invest in medical
countermeasures that combat drug-resistant microbes.
Our Nation continues to face emerging public health threats and it
is important that we are well positioned to adequately respond. The
budget continues to strengthen our domestic supply chain by investing
$95 million to accelerate development and domestic production of
medical countermeasures, and onshore production of active
pharmaceutical ingredients and essential medicines through the
Administration for Strategic Preparedness and Response. It also
includes $12 million to support the Food and Drug Administration (FDA)
in addressing medical and food shortages and $10 million for a new
supply chain coordination office within HHS.
As a continuation of our work to treat and prevent infectious
diseases, the budget also includes a new HHS-wide proposal to eliminate
hepatitis C infections in the United States. This 5-year program
focuses on high-risk populations and will increase access to curative
medications, and expand implementation of complementary efforts such as
screening, testing, and provider capacity.
advancing health in indian country
HHS remains committed to addressing the significant health
disparities faced by Tribal Nations and Native communities, and the
chronic underinvestment in the Indian Health Service. The budget
proposes $8.2 billion for IHS, a $1.1-billion increase above the 2023
enacted level. This includes the proposed reauthorization of the
Special Diabetes Program for Indians. This will maintain direct health-
care service levels, address targeted public health issues, and advance
critical operational efforts like health information technology
modernization.
Beginning in FY 2026, the budget proposes full mandatory funding
for all IHS accounts, and automatically grows funding each year to
account for factors like inflation and pay. This approach will address
chronic underinvestment by ensuring funding grows along with IHS's
needs. The budget also includes a dedicated funding stream for public
health capacity and infrastructure needs in Indian Country, a key
lesson learned from the pandemic.
This budget also addresses health-care workforce needs across the
Indian Health Service by providing hiring authorities to improve the
recruitment and retention of providers in our system. Workforce
challenges--including significant staffing needs in behavioral health
fields, such as substance use disorder care--are one of the top
concerns raised by Tribes to HHS. Addressing these challenges is
critical to providing better-quality health care to the people IHS
serves and to continuing to fight the concurrent substance use and
suicide crises Tribes are currently facing.
The Department will continue to partner with Tribes and Congress to
realize mandatory funding, and to ensure we can continue to provide
advance discretionary appropriations so IHS can maintain critical
health-care services if there is a lapse in appropriations.
advancing science to improve health
Cancer impacts Americans of all ages and from all walks of life.
Decreasing the cancer death rate and the number of loved ones we lose
to the disease remains a top priority for the administration. The Biden
Cancer Moonshot set ambitious goals to cut the cancer death rate by 50
percent over 25 years, preventing more than 4 million cancer deaths by
2047, and to improve the experience of people touched by cancer. The FY
2025 budget invests $2.9 billion across the Department to make that
possible, including $716 million in discretionary resources at the NIH
National Cancer Institute to continue their efforts to speed delivery
of cancer drugs and vaccines and ensure access to current and new
standards of cancer care. An additional $100 million increase for CDC
will support cancer prevention activities, including tobacco prevention
and cessation. The Advanced Research Projects Agency for Health (ARPA-
H) will also support Cancer Moonshot goals by investing in the
development of unprecedented breakthroughs to prevent, detect, and
treat cancer.
Additionally, ARPA-H will maintain its role as a catalyst for
transformation in the health ecosystem--including through its recently
announced Sprint for Women's Health. With its $1.5 billion budget, the
agency will continue finding real-world solutions for real-world
problems, driving biomedical innovation in a variety of arenas.
The budget continues the administration's commitment to support
scientific innovation. It includes $50.1 billion in total resources for
NIH, prioritizing in particular women's health research and firearms
and gun violence research with additional funds. The budget also
continues to support Brain Research through Advancing Innovative
Neurotechnologies, All of Us, and important research on opioids and
pain management, HIV/AIDS, and health disparities to improve American
health outcomes.
To keep our Nation at the forefront of scientific innovation, we
must seize the promise of artificial intelligence--while also managing
its risks. NIH is committed to harnessing the power of artificial
intelligence to advance research, and has already launched ambitious
initiatives to propel the fusion of biomedicine and artificial
intelligence and machine learning. In addition, the FY 2025 budget
provides resources to oversee artificial intelligence within the
Department to advance its responsible use in public health and health
care.
The FY 2025 budget also invests in scientific research that has
resulted in significant improvements to American lives. CDC's overall
budget--increased by $499 million--prioritizes investments in areas
such as improving public health data, preventing and mitigating the
impact of infectious diseases, reducing injury and violence, and
protecting against environmental health hazards. The budget also
provides a total of $513 million to the Agency for Healthcare Research
and Quality to further invest in their mission to produce scientific
evidence that makes health care better, more accessible, and more
affordable.
supporting program operations and mission-critical infrastructure
HHS needs sufficient operational funding to fulfill our mission.
This includes resources to allow the Office of the Secretary to oversee
the Federal Government's largest budget. The budget makes badly needed
investments in Centers for Medicare and Medicaid Services (CMS) program
management to ensure CMS can carry out its core operations, such as
surveying hospitals and nursing homes to ensure quality care is being
delivered to millions of Medicare and Medicaid enrollees. It also
invests in FDA to support the agency's expert staff that ensures the
safety of our food supply, guarantees the effectiveness of our
medicines, and that conduct rigorous and transparent scientific
reviews.
The Nonrecurring Expenses Fund is a key source of funding for
departmental operations. The Fund permits HHS to transfer unobligated
balances of expired discretionary funds into an account for necessary
information technology and facilities infrastructure acquisitions.
Since FY 2013, the fund has allocated over $6.5 billion in capital
investment projects across the Department. HHS's proposed FY 2025
projects will address aging systems and facilities, including at IHS,
NIH, and CDC. These improvements are integral in improving the health
and well-being of the American people.
A fundamental component of HHS's infrastructure is its
cybersecurity capabilities. We have seen a dramatic rise in large data
breaches reported to HHS, and the health-care information HHS protects
is a prime target for cybercriminals. Our plan sets the direction for
cybersecurity in health care, both from a policy and operational lens,
and commits HHS to pursuing new priorities to both strengthen and
support the sector at this critical time. The FY 2025 budget
prioritizes investments to address cybersecurity threats and invests
$141 million in cybersecurity initiatives in the Office of the Chief
Information Officer to address cybersecurity mandates and allow
deployment of cybersecurity initiatives and tools that will keep the
Department at the forefront in battling ever-evolving cyber threats.
The investment in cybersecurity includes $11 million for the
Department's Health Insurance Portability and Accountability Act
modernization to increase compliance, enhance the privacy and security
of health information, and to improve breach prevention and response
efforts. The budget also includes an increase of $12 million above FY
2023 for ASPR as the agency designated to coordinate cybersecurity
incident prevention and response in the health care and public health
sector. The budget also establishes a Medicare incentive program to
encourage hospitals to adopt essential and enhanced cybersecurity
practices.
The budget also invests in civil rights enforcement to ensure we do
our part to protect the American people's fundamental rights of
nondiscrimination and health information privacy. The budget provides
the HHS Office for Civil Rights a $17-
million increase, which includes a robust investment in enforcement
staff to address and resolve major case increases that have led to a
significant backlog.
HHS also invests in program integrity and promoting competition to
support our commitment to good stewardship of taxpayer dollars. Our
responsibility is to ensure that every dollar entrusted to us directly
enhances the lives of the American people. The budget invests a total
of $4 billion over 10 years in new mandatory health-care fraud and
abuse control funding to provide oversight of nursing homes, managed
care, and community-based settings. This mandatory investment will
yield a net savings of $5 billion over 10 years. Additionally, the
budget provides increased funding to the discretionary health-care
fraud and abuse control program and the HHS Office of Inspector General
to support its oversight.
improving the customer experience for the american public
Lastly, I wanted to talk about how we are making government and
government programs easier for American people to access and use. HHS
is improving customer experience throughout the Department, mostly
using current administrative funds. In FY 2025, the budget includes an
$11-million investment for the Department to improve data services for
benefits delivery, as well as $3 million to support the Streamlining
Medicare-only Enrollment project, among other efforts. These
investments are bolstered by the HHS-wide customer experience
initiative launched in FY 2024, one of the largest such initiatives in
the Federal Government to date. Our goal is to provide a customer
experience that ensures the public can access and utilize the impactful
resources within HHS. As part of the initiative, every agency within
HHS will pursue substantial projects to improve services to the
American people. This expands on the many customer experience
initiatives HHS has already pursued. For example, HHS continues to
partner with other departments and agencies through the Life
Experiences initiative to streamline enrollment and eligibility across
benefits programs such as Medicaid and the U.S. Department of
Agriculture's Supplemental Nutrition Assistance Program, increase
access to decision-making support for older adults, reduce burdensome
and repetitive manual income verifications, and support States in
innovating and improving Federal-State benefits access and delivery.
conclusion
I am honored to lead the Department of Health and Human Services,
working alongside dedicated civil servants to enhance the health and
well-being of the American people. Investments in this budget will
allow us to continue fulfilling our mission, and we know you are all
critical partners in achieving this goal. We are grateful for your
support of the Department, and we are excited to work with you on
funding for FY 2025.
I want to thank the committee for inviting me to discuss the
President's Fiscal Year 2025 budget for Health and Human Services. I
look forward to working with you to fulfill that vision. Thank you for
your partnership in advancing our shared goal to improve the health,
safety, and well-being of our Nation.
______
Questions Submitted for the Record to Hon. Xavier Becerra
Questions Submitted by Hon. Ron Wyden
Question. Artificial intelligence (AI) systems are currently being
developed and deployed across the health-care system to address
challenges including workforce shortages, rising costs, and persistent
disparities in access to care. The Federal Government in general, and
Health and Human Services (HHS) in particular, have a critical role to
play in protecting patients and their privacy and, at the same time,
fostering innovation.
To this end, the Biden administration has tasked HHS with numerous
key responsibilities in AI governance over the last year. In October
2023, President Biden released Executive Order (EO) 14110 on Safe,
Secure, and Trustworthy Development and Use of Artificial Intelligence
that required HHS to, among other responsibilities, establish an HHS AI
Task Force, develop a strategy to assess AI quality, and establish an
AI safety program.
However, the HHS FY 2025 budget includes only a single sentence
describing investments in the Department's ``role in promoting the use
of artificial intelligence in health care and public health while
protecting against its risks.'' I am concerned that HHS is not
adequately preparing for what are likely to be significant changes
across the healthcare system as a result of the widespread deployment
of AI systems.
What activities is HHS planning to invest in over FY 2025 with
respect to AI?
What steps will HHS be taking to protect patients across the
health-care system from harmful AI systems, especially those enrolled
in Federal health programs like Medicare and Medicaid?
What is HHS doing to address States and Medicaid managed care
entities' use of AI when conducting eligibility and benefits
determinations in the Medicaid/CHIP program?
How is CMS assessing and enforcing the requirement that MA
organizations make medical necessity coverage decisions ``based on the
circumstances of the specific individual, as outlined at
Sec. 422.101(c), as opposed to using an algorithm or software that
doesn't account for an individual's circumstances?''
Answer. On October 30, 2023, President Biden issued an EO \1\ to
help ensure the safe, responsible deployment and use of AI in the
health-care, public-health, and human-services sectors. Among other
items, the EO requires the Secretary of HHS, in consultation with the
Secretary of Defense and the Secretary of Veterans Affairs, to
establish an HHS AI Task Force that shall, within 365 days of its
creation, develop a strategic plan that includes policies and
frameworks--possibly including regulatory action, as appropriate--on
responsible deployment and use of AI and AI-
enabled technologies in the health and human services sector (including
research and discovery, drug and device safety, health-care delivery
and financing, and public health), and identify appropriate guidance
and resources to promote deployment. CMS is actively participating in
HHS's efforts and building our knowledge and capabilities in this
space. We are reviewing the feedback we have received on this issue for
potential future rulemaking. In this way, we are positioning ourselves
to respond agilely to any developments which could negatively impact
beneficiaries of CMS programs and provide guardrails that will enable
our programs to safely reap the benefits of these technological
innovations.
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\1\ Available at Executive Order on the Safe, Secure, and
Trustworthy Development and Use of Artificial Intelligence | The White
House, https://www.whitehouse.gov/briefing-room/presidential-actions/
2023/10/30/executive-order-on-the-safe-secure-and-trustworthy-
development-and-use-of-artificial-intelligence/.
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medicaid managed care
CMS is committed to partnering with States to help strengthen the
monitoring and oversight of Medicaid managed care programs. The
increased prevalence of the use of managed care delivery systems over
the past several years underscores the continued need for strong
Federal and State oversight of Medicaid managed care. CMS has taken a
number of steps to support States, including developing a series of
technical assistance tools and toolkits that States are encouraged to
use to improve the monitoring and oversight of their managed care
programs.
The regulations at 42 CFR Sec. 438.210 allow managed care plans to
implement prior authorization processes, so long as certain
requirements are met. Managed care plans must also comply with the
grievance and appeal system requirements laid out in 42 CFR part 438,
subpart F, including the requirement that they can only have one level
of appeal at the plan level before a beneficiary has access to a State
fair hearing under 42 CFR part 431, subpart F. The 2016 Medicaid and
Children's Health Insurance Program (CHIP) Programs; Medicaid Managed
Care, CHIP Delivered in Managed Care, and Revisions Related to Third
Party Liability Final Rule (CMS-2390-F) clarified that States could
offer enrollees the option of an external medical review, as long as
the review is provided at the enrollee's option, is not a requirement,
and is not used as a deterrent to proceeding to the State fair hearing.
Further, if States want to offer enrollees the option of an external
medical review, it must be independent of both the State and managed
care plan and must be offered without any cost to the enrollee. Some
States have utilized this flexibility and chose to offer an external
medical review to enrollees when the managed care plan upheld the
initial prior authorization denial. In addition, CMS, in January,
finalized the CMS Interoperability and Prior Authorization (CMS-0057-F)
rule that requires managed care plans, beginning in 2026, to publicly
report certain metrics about prior authorization, including the percent
of prior authorization requests that were approved, denied, or approved
after appeal. The rule also requires managed care plans to make
detailed information about prior authorization requests and decisions
for items and services (excluding drugs) available to providers
electronically, significantly shortens response times for the managed
care plan to respond to a prior authorization request and requires that
the prior authorization status be made available to enrollees
electronically within one business day. In the case of a prior
authorization denial, the managed care plan must provide a specific
reason for all denied requests. These policies and activities help
address concerns about the use of AI in Medicaid managed care.
medicare advantage
An algorithm or software tool can be used to assist MA plans in
making coverage determinations, but it is the responsibility of the MA
organization to ensure that the algorithm or artificial intelligence
complies with all applicable rules for how coverage determinations by
MA organizations are made.
CMS will conduct both routine and focused program audits of
organizations in 2024 to assess compliance with the coverage and
utilization management (UM) requirements finalized in the CY 2024 final
rule. For Medicare Advantage organizations (MAOs) that have routine
program audits scheduled for 2024, these audits will follow our
standard process similar to prior years, covering all applicable
program areas, but will target the new UM requirements during the Part
C Organization Determinations, Appeals, and Grievances (ODAG) review,
as well as the Compliance Program Effectiveness (CPE) review. In
addition, CMS is also adding new focused audits for plans that don't
have routine scheduled audits, which are limited to ODAG and CPE, and
are designed specifically to target compliance with the coverage and UM
policies in the CY 2024 final rule. Through this combination of routine
and focused audits in 2024, CMS expects to evaluate the UM-related
performance of plans serving approximately 88 percent of people with
MA. This expansion of our audit activity will help make sure that MA
beneficiaries get the care they need without excessive burden or delays
and have access to the benefits and services to which they are
entitled. During both the routine and focused program audits, CMS will
utilize physician reviewers to review denied requests to assess whether
MAOs are meeting clinical coverage requirements, such as following
coverage and benefit conditions included in Medicare laws, National
Coverage Determinations (NCD), or Local Coverage Determinations (LCD),
and when permissible, applying internal coverage criteria only when
coverage criteria are not fully established in statute, regulation,
NCDs, and LCDs.
CMS program audits will also ensure that internal coverage criteria
are publicly available and otherwise meet regulatory requirements, MAOs
are only using physicians (or other appropriate health care
professionals) with appropriate expertise in the field of medicine for
the service at issue when issuing adverse medical necessity decisions,
and MAOs have established UM committees in accordance with regulatory
requirements, including who the members of the committee are and the
responsibilities they are required to complete.
We will be monitoring closely whether MA plans are utilizing and
applying internal coverage criteria that are not found in Medicare
laws, NCDs, or LCDs, and whether the internal coverage criteria are
publicly accessible and coverage policies meet the regulatory
requirements.
CMS has a number of tools it can use to address noncompliance with
the new requirements, including issuing compliance and enforcement
actions. Compliance actions include Notices of Non-Compliance, Warning
Letters, and Requiring Corrective Action Plans.
These policies and activities help address concerns about the use
of AI in Medicare Advantage.
Question. In December 2023, the Government Accountability Office
(GAO) published a report recommending that HHS take action to achieve
consistency with Executive Order 13960 on Promoting the Use of
Trustworthy Artificial Intelligence in the Federal Government by
retiring AI applications used in manners inconsistent with the EO and
keeping up to date its public AI use case inventory. The report found
that HHS's public AI use case inventory had data gaps or inaccuracy and
incorrectly included research and development use cases.
By when will HHS update its public AI use case inventory to be in
compliance with the latest Federal guidance on trustworthy and
responsible AI, including the National Institute of Standards and
Technology AI Risk Management Framework, EO 14110, and EO 13960?
Answer. On October 30, 2023, President Biden took action by signing
EO 14110 on the Safe, Secure, and Trustworthy Development and Use of
Artificial Intelligence. As of the date of the hearing, it is our
understanding that OMB intends to issue a memorandum about detailed
reporting requirements for forthcoming collections of agency AI use
case inventories. The Department looks forward to receiving the formal
memorandum and detailed reporting requirements (including dates) from
OMB and will implement them as directed.
______
Questions Submitted by Hon. Mike Crapo
unitedhealth group and change healthcare cyberattack
Question. What tools are currently at your disposal to mitigate the
ongoing damage due to the Change Healthcare cyberattack?
How are you ensuring that UHG is providing the needed support to
its customers that are heavily reliant on the Change Healthcare IT
platforms?
Do you know if any private personal information (PPI) was exposed
during this attack?
Answer. We recognize the impact the attack on Change Healthcare has
had on health-care operations across the country. HHS has acted with
urgency in responding to this incident, and our first priority--as it
is with any cyberattack on the Healthcare and Public Health (HPH)
sector--has been to coordinate efforts to avoid disruptions to care and
protect patient safety. Looking beyond this incident, the
Administration for Strategic Preparedness and Response (ASPR) serves as
the Sector Risk Management Agency for the HPH sector and HHS has
recently established a cybersecurity ``one-stop shop'' within ASPR to
manage collaboration and information sharing with other HHS divisions,
the health-care industry, as well as the interagency. Efforts to
bolster the sector's cybersecurity will be led from this new office. In
December 2023, HHS released a concept paper that outlined the
Department's holistic cybersecurity strategy for the health-care
sector. In January 2024 the department published voluntary HPH
Cybersecurity Performance Goals (HPH CPGs),\2\ which are intended to
help health-care institutions plan and prioritize implementation of
high-impact cybersecurity practices. In the coming weeks and months as
we emerge from this attack, we will be focused on developing additional
tools, resources, and guidance to help with implementing these HPH CPGs
and look forward to working with the sector to help improve its cyber
posture.
---------------------------------------------------------------------------
\2\ https://gcc02.safelinks.protection.outlook.com/
?url=https%3A%2F%2Fhphcyber.hhs.gov%2F&
data=05%7C02%7CAshley.Charest%40hhs.gov%7C04c2de177f6e4475cecd08dc543aeb
76%7Cd58a
ddea50534a808499ba4d944910df%7C0%7C0%7C638477859235644990%7CUnknown%7CTW
Fpb
GZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3
D%7
C0%7C%7C%7C&sdata=juRPtubsFn253Sv5dmYXhzVCbGatHFRS%2Fp6P6139jww%3D&re
served=0.
Additionally, CMS has taken several key actions to support the
provider community during this difficult situation, including making
available accelerated and advance payments to ease cash flow
disruptions experienced by some Medicare providers and suppliers, such
as hospitals, physicians, and pharmacists, due to the unprecedented
cyberattack that took health care electronic data interchange Change
Healthcare offline in February. CMS has also provided flexibility for
certain Medicare reporting deadlines. We encourage Medicare Advantage
and Medicare Part D plans as well as Medicaid and CHIP managed care
plans to offer advance funding to providers, and to remove or relax
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certain timely filing and prior authorization requirements.
Question. Historically, neither Congress nor CMS has mandated that
skilled nursing facilities (SNFs) and nursing facilities (NFs) maintain
a minimum nurse staffing level. Most private and public research has
recognized the overall complexity of this issue, including how to
calculate the so-called right minimum staffing number.
The administration's recently proposed minimum nurse staffing
standards rule is a misguided attempt to force increased levels of
direct resident care in SNFs and nursing homes. Because one-size-fits-
all staffing mandates do not account for individual facility
operational capabilities, capacity, and unique workforce conditions,
the proposed rule is unlikely to achieve its desired result. Many long-
term care facilities, particularly those in rural communities, will be
forced to further limit access to care, or they will close altogether.
Do you think it is appropriate for CMS to impose a $40.6-billion
unfunded mandate on long-term care providers over the next 10 years
without including any Federal resources to assist facilities needing to
come into compliance?
Why did the CMS proposed rule fail to include any discussion,
relevant research, or economic impact analysis showing the number of
long-term care facilities that will be forced to close due to the
administration's proposal?
The proposed rule indicates that it will not increase Medicaid
costs. The Congressional Budget Office (CBO), however, disagrees. CBO
estimates the Medicaid budgetary effects of the proposed rule to be
about $8.7 billion over the 2024-2034 period. How confident are you
that the administration is not imposing sizeable compliance costs onto
State Medicaid programs? Have you discussed this with the Governors?
Answer. Staffing in LTC facilities is a persistent concern,
especially among low-performing facilities that are at most risk for
providing unsafe care. Numerous studies have shown that staffing levels
are closely correlated with the quality of care that LTC facility
residents receive.\3\ CMS believes that national minimum nurse staffing
standards in LTC facilities are necessary at this time to protect
resident health and safety and ensure residents' needs are met. At the
same time, CMS acknowledges the unique challenges that rural LTC
facilities face, especially related to staffing, and recognizes the
need to strike an appropriate balance that considers the current
challenges some LTC facilities are experiencing.
---------------------------------------------------------------------------
\3\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive Report. Report prepared for the Centers for Medicare and
Medicaid Services.
With respect to the impact of this proposal on long-term care
providers, CMS fully expects that LTC facilities will be able to meet
the proposed minimum staffing standards. CMS crafted this proposed rule
with careful consideration that many LTC facilities will need to
recruit, hire, and train new staff. For example, CMS proposed that
implementation of the final requirements will occur in three phases
over a 3-year period for all nonrural facilities. Rural facilities will
have 3 years to meet the proposed 24/7 R.N. requirement and 5 years to
meet the proposed minimum staffing requirements. If finalized, the
phased-in implementation will be helpful in that facilities may not
have to hire nursing staff all at once. We recognize that in some
instances, external circumstances may temporarily prevent a facility
from achieving compliance despite the facility's demonstrated best
efforts. To that end, we proposed to allow for a hardship exemption in
limited circumstances. If finalized, LTC facilities could qualify for a
---------------------------------------------------------------------------
temporary hardship exemption from the minimum.
Question. CMS implemented the Acute Care Hospital at Home
initiative at the beginning of the COVID-19 pandemic. Hospital at Home
allows participating hospitals and health systems to care for Medicare
patients, who meet inpatient hospital admission criteria, in the
comfort of their own home. Medicare pays the same rate as if the care
was provided in the traditional brick and mortar inpatient hospital
setting.
While patient satisfaction appears to be high, the Medicare claims
data is incomplete. According to MedPAC, the most recent available data
shows that 105 hospitals (37 percent of those participating) reported
discharges under the Hospital at Home initiative. These hospitals
reported 6,100 total patient discharges. Approximately 26 of the
largest participating hospitals accounted for 71 percent of that total
volume. MedPAC has said that this limited sample size makes evaluating
the Hospital at Home initiative extremely challenging. MedPAC also
reports that the Medicare claim forms only indicates the Hospital at
Home start date and end date. The claim forms apparently do not show
the type of practitioner providing medical care to the beneficiary.
They do not list the actual medical services furnished to the
beneficiary, and they do not indicate whether a caregiver lives in the
beneficiary's home. This means that current claims data cannot answer
key questions about patient selection, risk adjustment, quality
improvement, and financial viability.
The 2023 omnibus extended the CMS initiative through the end of
2024 and required HHS to submit a report to Congress, by September
30th, assessing Hospital at Home utilization, quality, outcomes, and
costs. Because MedPAC suggests that more time is needed in order to
conduct randomized trials that provide more reliable data, it is
unlikely that the HHS report will contain detailed recommendations to
Congress.
Has CMS considered extending the Hospital at Home initiative for an
additional 3- to 5-year period, under its Centers for Medicare and
Medicaid Innovation (CMMI) demonstration authority? Do you believe that
would help us understand more about its impact on hospital efficiency,
selection bias, participation capabilities in rural and frontier areas,
patient outcomes, and overall Medicare spending?
If you have no plans to use CMMI authority to extend the
initiative, then what steps do you think HHS and Congress should take
given the significant data gaps?
Answer. The Acute Care Hospital at Home initiative began in
November 2020 as a way to provide certain services in a patient's home
that would otherwise be provided to them as a hospital inpatient. This
was one of the actions taken by CMS to treat individuals safely during
the COVID-19 public health emergency. Under the initiative, the
Secretary grants certain waivers and flexibilities to hospitals that
submit an application and meet specified criteria. They also must agree
to submit required data, which CMS is releasing publicly at https://
www2.ccwdata.org/web/guest/data-dictionaries.
Section 4140 of the Consolidated Appropriations Act, 2023, extended
this initiative through the end of 2024. This law also requires that
additional data be collected, and that a study be done to analyze
certain factors, including: (1) the criteria used by hospitals to
determine which individuals may be furnished services at home; (2)
quality of care furnished to individuals with similar conditions and
characteristics in the inpatient setting and through the Acute Care
Hospital at Home initiative, including health outcomes and patient
experience of care; (3) costs of care; (4) quantity, mix, and intensity
of services; and (5) socioeconomic information on beneficiaries
treated. The study is required to be completed by September 30, 2024,
and will provide additional information about services furnished, best
practices, and outcomes. Continuation of the AHCAH initiative beyond
December 31, 2024, is contingent on further congressional action.
Question. The CMS proposed rule entitled, Ensuring Access to
Medicaid Services, includes a number of proposals aimed at improving
the quality of care for people receiving Medicaid home and community-
based services (HCBS). While I share the administration's goal of
improving transparency, quality, and access to HCBS, I am concerned
that the proposed rule would have the unintended consequence of
reducing access to these critical services.
In the proposed rule, CMS requires that at least 80 percent of
Medicaid payments for personal care, homemaker, and home health aide
services be spent on compensation for the direct-care workforce. Has
CMS conducted an analysis of the impact of this requirement on overall
Medicaid costs and beneficiary access to these services?
Answer. On April 27, 2023, CMS issued the Ensuring Access to
Medicaid Services proposed rule. A substantive component of this
proposed rule focuses on improving access to, and the quality of, HCBS.
Over the past several decades, HCBS have become a critical component of
the Medicaid program and are part of a larger framework of progress
toward community integration of older adults and people of all ages
with disabilities that spans efforts across the Federal Government. The
changes proposed in this rule are intended to strengthen necessary
safeguards to ensure health and welfare, promote health equity for
people receiving Medicaid-
covered HCBS, and achieve a more consistent and coordinated approach to
the administration of policies and procedures across Medicaid HCBS
programs. CMS presumes that references to the ``80/20 proposal'' are
references to the HCBS payment adequacy policy CMS proposed in this
rule, as further described below.
Access to most HCBS generally requires hands on and in-person
services to be delivered by direct-care workers. However, direct-care
worker shortages are impacting beneficiaries' access to services. In an
effort to address direct-care workforce shortages, CMS proposed to
require that States ensure that providers spend at least 80 percent of
Medicaid payments for homemaker, home health aide, and personal care
services on compensation for direct-care workers. We believe that this
proposal would not only benefit direct-care workers but also
individuals receiving Medicaid HCBS. We believe supporting and
stabilizing the direct-care workforce will result in better qualified
employees, lower turnover, and a higher quality of care.
This proposal was based on feedback from States that have
implemented similar requirements for payments for certain HCBS. These
States reported to us through various public engagement activities that
similar requirements have had their intended effect of ensuring that a
sufficient portion of the payment for Medicaid HCBS goes to
compensation for the direct-care workforce. These States also indicated
an 80-percent threshold is an appropriate threshold that takes into
account the expected portion of payments that are necessary for
provider administrative and other costs, aside from direct-care worker
compensation. CMS proposed compensation to be defined as salary, wages,
and other remuneration as defined by the Fair Labor Standards Act and
implementing regulations; benefits (such as health and dental benefits,
sick leave, and tuition reimbursement); and the employer share of
payroll taxes for direct-care workers delivering HCBS.
Additionally, this proposed rule would require the establishment of
an Interested Parties Advisory Group, to advise and consult with the
State on payment rates for direct-care workers. This group would
include, at a minimum, direct-care workers, beneficiaries and their
authorized representatives, and other interested parties.
Input from stakeholders is an important contribution to CMS's
policymaking process and CMS is carefully considering all comments
received during the comment period on this proposed rule as we work to
develop a final rule.
Question. The Medicaid Drug Rebate Program (MDRP) is critical to
ensuring that millions of Americans enrolled in Medicaid have access to
lifesaving medications. As intended by Congress, the MDRP both
preserves incentives for medical breakthroughs and contains costs for
State Medicaid programs.
Last May, CMS proposed a number of changes to the MDRP that
threaten to upend patient access to lifesaving therapies and cures.
While I agree with many of CMS's objectives in the proposed rule, I
remain concerned by the agency's decision to make changes to the MDRP
in ways that exceed its statutory authority. In October, I joined 10 of
my Senate Finance Committee colleagues in sending a letter to CMS
Administrator Brooks-LaSure expressing our concerns with several
policies included in the proposed rule.
The proposed rule would require manufacturers to aggregate, or
``stack,'' cumulative discounts, rebates, and other arrangements for
purposes of determining a drug's ``best price.'' There is currently no
system in place for aggregating this information, and the President's
budget request does not mention the need for such a system. How does
CMS plan to operationalize and enforce this requirement?
A recent Avalere analysis \4\ of the proposed rule noted that, if
finalized, the proposed rule may lead to manufacturers restructuring
discounts in other markets, including the commercial market. Has CMS
considered the impact of this proposed rule on patient access across
the prescription drug supply chain?
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\4\ https://avalere.com/wp-content/uploads/2023/12/Proposed-
Changes-to-Best-Price-Could-Shift-Market-Dynamics-for-
Stakeholders_1.pdf
Answer. CMS is currently in the rulemaking process and cannot
comment on or speculate about any potential changes to the proposed
policies or when a final rule may be issued. As always, we are closely
reviewing the comments received in response to the proposed rule. Input
from stakeholders is an important contribution to CMS's policymaking
process, and we are now considering the abundance of comments we
---------------------------------------------------------------------------
received during the public comment period.
Question. The President's budget proposes to establish a State
option to provide 36 months of continuous eligibility for children
under the age of 19. The budget justifies this proposal by stating that
it will ``provide more stable coverage, decrease State administrative
burden, and may avoid higher costs by addressing preventable care
needs.''
Has HHS received feedback from State Medicaid programs that the
current requirement to provide 12 months of continuous eligibility to
children in Medicaid and CHIP presents an administrative burden?
Answer. Disruptions in Medicaid and CHIP coverage often lead to
delayed care, unfilled prescriptions, and less preventive care for
beneficiaries. Stable coverage can help establish relationships between
providers and families to better address each child's individual needs.
The Consolidated Appropriations Act, 2023 (CAA, 2023), requires
that most children under the age of 19 who meet their State's Medicaid
or CHIP eligibility requirements remain continuously eligible for
coverage for a full 12-month period, effective January 1, 2024. Under
this Federal continuous eligibility (CE) policy, children would remain
eligible for coverage even if they experience an otherwise-
disqualifying change in circumstance (e.g., a change in household
composition or income).
Prior to the CAA, 2023, States had the option to provide up to 12
months CE to children under age 19 and could determine both the
duration of the CE period as well as the upper age limit for child
eligibility. The intended effect of the new Federal CE requirement is
to help reduce gaps in children's coverage due to fluctuations in
family income or other temporary changes in eligibility status. In
addition, CE has the potential to promote health equity by reducing
coverage loss in groups disproportionately impacted by disenrollment,
reduce administrative burden and costs, and promote uninterrupted
access to health-care services for children and youth which is expected
to improve their health outcomes.
The FY 2025 Biden-Harris budget builds on the requirement to
provide 12 months of continuous eligibility to children in Medicaid and
CHIP, enacted in the CAA, 2023, by establishing a State option to
provide continuous eligibility from birth until the child turns 6. This
will provide more stable coverage for young children enrolled in
Medicaid or CHIP, decrease State administrative burden, and may avoid
higher costs by addressing preventable care needs.
The budget further builds on the requirement to provide 12 months
of continuous eligibility by establishing a State option to provide 36
months of continuous eligibility for children under the age of 19. This
works in tandem with the proposal above to promote continuity of
coverage for children in Medicaid and CHIP. States selecting to
implement both State options would provide continuous eligibility to
children until they turn 6, then continuous eligibility periods of 36
months until they turn 19. This will provide more stable coverage,
decrease State administrative burden, and may avoid higher costs by
addressing preventable care needs.
Question. The President's budget proposes to reduce reimbursement
rates for placements in Qualified Residential Treatment Programs
(QRTPs) to 5 percent below each State's Federal match rate. As you are
aware, the bipartisan Family First Prevention Services Act, passed by
Congress in 2018, established QRTPs as time-limited and trauma-informed
care settings to be used only when clinically necessary, with the goal
of preparing a child to return safely to their family and community.
Between 2019 and 2021, hospitals saw a nearly three-fold increase
\5\ in the number of pediatric patients who spent time boarding in
emergency departments as they await psychiatric treatment.
---------------------------------------------------------------------------
\5\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9822692/
How does limiting reimbursement rates for QRTPs help to ameliorate
the pediatric boarding crisis currently experienced by hospital
---------------------------------------------------------------------------
emergency departments across the country?
As a justification for this proposal, the President's budget cites
``more than 20 studies published over 2 decades'' that support that
youth fare better in family foster care than in residential care. The
Family First Prevention Services Act was enacted 6 years ago.
Do any of the studies cited consider the role of QRTPs in providing
care to youth that may need clinically indicated, short-term
residential treatment?
Answer. The proposal is one part of the administration's
comprehensive child welfare budget proposals. Taken together, these
proposals would reduce the number of children entering foster care, and
for children who do need to enter care, would ensure more children are
placed with kin and fewer are placed in congregate care facilities.
This proposal aligns Federal financing with best practices, since most
children do best in family settings. Across more than 20 studies
published over 2 decades, researchers found that youth in family foster
care consistently fared better than youth in residential care on
outcomes relating to both internalizing behaviors (such as depression)
and externalizing behaviors (acting out). In addition, studies have
found that youth in family foster care have better educational outcomes
and are much less likely to become delinquent than those who experience
residential care.
Question. In its 2025 Medicare Advantage (MA) and Part D proposed
rule, CMS seeks to implement certain changes to agent and broker
compensation for enrollment. Stakeholders have raised concerns about
how the proposed rule operates and what organizations would be subject
to the new regulations. Agents and brokers play an important role in
helping seniors select and enroll in the MA plan that best meets their
needs, and it is important to avoid unintended consequences that could
adversely impact beneficiaries.
Does CMS's proposed limit on fees for administrative services only
apply to brokers and agents or would it also apply to field marketing
organizations (FMOs) and third-party marketing organizations (TPMOs)?
Will you commit to working with relevant stakeholders before
issuing any final or future rulemaking in order to ensure seniors
continue to have the resources they need to navigate the enrollment
process?
Answer. We agree that it is critical to ensure that as the MA and
Part D programs continue to grow, they remain viable and that seniors
and individuals with disabilities eligible for Medicare can make
informed decisions about their health-care coverage, and, when
appropriate, enroll in the plan that is best suited to their personal
health-care needs. As discussed in the CY 2025 MA and Part D proposed
rule, section 1851(j) of the Social Security Act requires that CMS
develop guidelines to ensure that the use of compensation creates
incentives for agents and brokers to enroll individuals in the MA plan
that is intended to best meet their health-care needs. We have learned,
however, that many MA and stand-alone Prescription Drug Plans (PDP), as
well as third-party entities with which they contract (such as field
marketing organizations (FMO)), have structured payments to agents and
brokers that have the effect of circumventing existing CMS regulations
that limit agent and broker compensation to specified fair market value
(FMV) levels. CMS has also received complaints from different
organizations, including State partners, beneficiary advocacy
organizations, and MA plans to this effect. A common thread to the
complaints is that agents and brokers are being paid, typically through
various purported administrative and other add-on payments, amounts
that cumulatively exceed the maximum compensation allowed under the
current regulations. Moreover, CMS has observed that such payments have
created an environment, not dissimilar to what originally prompted us
to set limits on agent and broker compensation in 2008, where the
amounts being paid for activities that do not fall under the umbrella
of ``compensation,'' are rapidly increasing.
We understand that FMOs help millions of Medicare beneficiaries to
learn about and enroll in Medicare, Medigap, MA plans, and PDP plans by
providing guidance on plan options, including comparisons of relative
costs and coverage, as well as assisting beneficiaries with applying
for financial assistance.
In our proposed rule, CMS is focused on current payment structures
among MA organizations, agents, brokers, and third-party marketing
organizations (TMPO), including FMOs, that may incentivize agents or
brokers to emphasize or prioritize one plan over another, irrespective
of the beneficiary's needs, leading to enrollment in a plan that does
not best fit the beneficiary's needs and a distortion of the
competitive process. In this rule, CMS has proposed to: (1) generally
prohibit contract terms between MA organizations and agents, brokers,
or other TMPOs that may interfere with the agent's or broker's ability
to objectively assess and recommend the plan which best fits a
beneficiary's health-care needs; (2) set a single agent and broker
compensation rate for all plans, while revising the scope of what is
considered ``compensation''; and (3) eliminate the regulatory framework
which currently allows for separate payment to agents and brokers for
administrative services.
CMS is committed to collaborating and engaging with stakeholders
and interested parties in the policymaking process. The comment period
for the CY 2025 MA and Part D proposed rule closed on January 5, 2024.
CMS sought comment on these proposals to further inform our
calculations and policy direction. We have received feedback from many
interested parties on our proposed policy, and we will carefully
consider these comments throughout this rulemaking process.
Question. Recent years have seen robust advances in
radiopharmaceuticals, with respect to both diagnostic tools and
therapeutics. In CMS's 2024 Medicare Outpatient Prospective Payment
System (OPPS) proposed rule, the agency acknowledged the inadequacy of
current OPPS packaging policies to account for diagnostic
radiopharmaceuticals (DRPs) in particular, given the high fixed costs,
limited radioisotope half-lives, raw material needs, and logistically
complex production and distribution processes associated with many of
these products.
As a range of medical providers noted in response to the comment
solicitation on potential policy alternatives to CMS's current
regulatory packing approach, advanced DRPs bear little resemblance to
the older contrast and stress agents underlying the agency's initial
decision to treat these technologies as supplies for imaging services,
with no prospect for separate payment after transitional pass-through
(TPT) status expiration. In the absence of a shift in reimbursement
policy with respect to DRPs, many, if not most, hospital outpatient
departments (HOPDs) will have no choice but to forgo these options,
even when medically necessary and clinically appropriate, given the
costs and complexities associated with DRP acquisition and
administration. As a result, beneficiary access to groundbreaking,
safe, and effective imaging services will continue to suffer.
Fortunately, movement away from the current categorical packaging
policy would require no congressional action, as the agency first
adopted the current methodology in the course of the Calendar Year (CY)
2008 rulemaking policy and presently maintains the tools and
authorities needed to modernize reimbursement regulations regarding
certain DRPs through the forthcoming CY 2025 OPPS rulemaking cycle, now
informed by scores of constructive comments submitted by providers,
clinicians, patient advocacy organizations, researchers, and
innovators, among other experts and stakeholders, in response to last
year's comment solicitation.
Moreover, as the agency rightly recognized in the course of the CY
2024 proposed rule, targeted action on this front could facilitate
greater simplicity, streamlining, and consistency across the
prospective payment system, particularly if implemented in alignment
with existing separate payment policies applicable to other FDA-
approved pharmaceutical products that exceed a stipulated cost
threshold. This type of approach, as specified under the first option
outlined in CMS's solicitation, would simply extend existing regulatory
provisions for other such products to DRPs, with no need for
potentially costly or burdensome billing and payment system changes.
The adoption of this approach would also trigger no outlay increases
under Part B, given the OPPS's requisite statutory budget-neutrality
adjustments.
For conditions like prostate cancer, Alzheimer's, and lung disease,
along with numerous rare disorders, DRPs have become an indispensable
component of the diagnostic imaging process, enabling better-targeted
and more effective treatment. In the context of theranostics, for
instance, DRPs play a central role in the delivery of therapeutic
radiopharmaceuticals. Without access to the former, the latter cannot
function.
With these and other considerations in mind, will you commit to
leveraging this year's OPPS rulemaking cycle to take the steps needed
to ensure meaningful and sustainable beneficiary access to FDA-approved
DRPs, when reasonable and necessary for diagnostic and/or treatment
purposes?
Answer. Under the OPPS, CMS packages several categories of nonpass-
through drugs, biologicals, and radiopharmaceuticals, regardless of the
cost of the products. In particular, under Sec. 419.2(b)(15), payment
for drugs, biologicals, and radiopharmaceuticals that function as
supplies when used in a diagnostic test or procedure is packaged with
the payment for the related procedure or service. Diagnostic
radiopharmaceuticals, which include contrast agents, stress agents, and
other products, are one specific type of product that is policy
packaged.
In the Calendar Year 2024 OPPS/ASC proposed rule, CMS solicited
comment on a number of potential new approaches to payment for
diagnostic radiopharmaceuticals that would enhance beneficiary access,
while also maintaining the principles of the outpatient prospective
payment system. Overall, commenters described clinical scenarios in
which they believed CMS's payment policies created the most significant
access issues, and accordingly, commenters urged CMS to reform payment
policy for diagnostic radiopharmaceuticals to address these concerns.
However, there was not a general consensus among commenters as to the
most effective way for CMS to reform its OPPS diagnostic
radiopharmaceutical payment policy.
CMS agrees this is a complex and important issue and, given the
wide array of information presented through the public comment process,
we intend to further consider these points and take them into
consideration for future notice and comment rulemaking. CMS welcomes
ongoing dialogue and engagement from stakeholders regarding suggestions
for potential future payment changes.
Question. While CMS understandably turned its attention, in the
course of last year's OPPS rulemaking cycle, to DRPs, providers and
patient advocates have also raised concerns around access to innovative
FDA-approved therapeutic radiopharmaceuticals. To that end, one such
product, Azedra, made news in recent years as the first and only FDA-
approved radiopharmaceutical indicated to treat pheochromocytoma and
paraganglioma, two families of rare and debilitating cancers.
Unfortunately, per an announcement from last August, patients will no
longer have access to this breakthrough orphan drug, constraining
treatment options, due in part to inadequate uptake.
Inadequate reimbursement policies, coupled with the high fixed
costs and complexities for therapeutics like Azedra, have made patient
access increasingly untenable, with dire implications not just for
approved radiopharmaceuticals, but also for the current and future
pipelines of rare disease treatments and other cutting-edge therapies.
Will you commit to taking regulatory and subregulatory steps, in
partnership with Congress and relevant stakeholders, to ensure that
reimbursement policies provide adequate incentives to sustain the
availability of breakthrough products like Azedra, as well as to
improve access for rare disease treatments writ large?
Answer. We are committed to promoting higher-quality cancer care
and improving outcomes for Medicare beneficiaries while reducing costs.
The Hospital Outpatient Prospective Payment System (OPPS) pass-through
and Inpatient Prospective Payment System (IPPS) New Technology Add-on
Payment (NTAP) collectively incentivize hospitals to quickly adopt and
promote beneficiary access to innovative technologies through
additional payments. Section 1886(d)(5)(K) of the act requires the
Secretary to establish a mechanism to recognize the costs of new
medical services and technologies under the IPPS.
The OPPS transitional pass-through provisions appear in section
1833(t)(6) of the Social Security Act. Transitional pass-through
payments provide additional payment for new devices, drugs, and
biologicals that met eligibility criteria for a period of at least 2
years but not more than 3 years while CMS gathers additional data on
the cost of those items. The intent of pass-through payments is to help
facilitate patient access to technologies that are too new to be well
represented in the data that CMS uses to set OPPS payment rates. While
new technology APCs are payments for complete services, pass-through
payments are for specific drugs, biologicals, and devices that
providers use in the delivery of services. After the pass-through
payment period expires, drugs continue to receive separate payment if
they exceed the packaging threshold of $135 per day and are not among
the types of drugs, biologicals, or radiopharmaceuticals for which
payment is packaged.
Question. As CMS continues to progress through the first price
negotiation cycle under the central program established under the IRA,
patient advocates and providers have raised a number of questions
around potential systemic improvements for future cycles, especially
with respect to data transparency.
In particular, uncertainty and unpredictability regarding the drugs
likely slated for selection, with respect to any given round of the
program's process, can complicate planning processes, along with
negotiations and transactions across the supply chain, potentially
imperiling patient access and triggering needless costs among
providers, pharmacies, wholesalers, and other stakeholders. To that
end, the publicly available Medicare Part D Drug Dashboard data
accessible in advance of the agency's first selected drug announcement
last year served as an outdated and poor proxy for the actual outlay
window leveraged by the agency as the basis for its selections. Few, if
any, analyses attempting to model the first 10 drug selections managed
to do so with a high degree of accuracy, even allowing for inherent
uncertainty at the margins.
More transparent and readily available data on the drug spending
figures used to select medications for inclusion in the program would
help to mitigate unpredictability and volatility across the
prescription drug supply chain. Furthermore, greater clarity on the
agency's approach to identifying which generic or biosimilar products
meet CMS's ``bona fide'' marketing criteria could help to alleviate
additional questions and uncertainties, which otherwise risk
undermining investments in future candidate generic and biosimilar
competitors.
With respect to biosimilars, for instance, pharmacy benefit
managers and plan sponsors routinely exclude the lowest-cost
biosimilars from their formularies, resulting in anemic utilization, as
both the insulin market and the Humira biosimilar landscape have
demonstrated. That said, if CMS opts not to treat biosimilars subject
to broad formulary exclusions and aggressive utilization management
protocols as ``bona fide,'' then their branded reference products could
end up with guaranteed formulary placement under the IRA's selected
drug stipulations (once Secretary-set pricing applies), further
constraining market share for these would-be competitors in favor of
branded counterparts.
What steps does CMS, or HHS more broadly, plan to take in order to
ensure timelier public access to the cost data underlying drug
selection for the program? Does the agency plan to allocate a portion
of the $3 billion directed toward implementation for the program to
this effect?
Can you commit to providing a more clear and concrete definition
for ``bona fide'' marketing in the context of generics and biosimilars,
ideally accounting for the fact that even a marketed and commercialized
biosimilar product may see extremely low uptake and utilization based
on factors outside of the control of the relevant manufacturer, such as
PBM and plan sponsor formulary exclusions or less favorable formulary
placement?
Answer. Sections 1191(d)(3)(B) and 1192(d)(1)(A) of the Social
Security Act require CMS to identify negotiation-eligible drugs for
initial price applicability year 2026 using data on ``total
expenditures'' under Part D during the period beginning on June 1,
2022, and ending on May 31, 2023. Currently, the Part D Drug Spending
Dashboard allows for a longer claims run out to provide time for claims
to be submitted, processed, and finalized than is possible for the data
that CMS is statutorily required to use to identify and rank
negotiation-eligible drugs. While CMS works to implement the new
prescription drug law, we also plan to continue our annual updates to
the Drug Spending Dashboards to provide the public with comprehensive
data on trends related to drug spending for people with Medicare and
Medicaid.
In the Medicare Drug Price Negotiation Program: Revised Guidance,
issued June 30, 2023, CMS clarified the process it will use to
determine if bona fide marketing of a generic drug or biosimilar
competitor to a potential qualifying single source drug is occurring
for the purposes of drug selection. CMS will review both Prescription
Drug Event (PDE) data and Average Manufacturer Price (AMP) data
reported by manufacturers. The determination whether a generic drug or
biosimilar is marketed on a bona fide basis will be based on a totality
of the circumstances, including PDE and AMP data.
CMS clarified that, in addition to monitoring PDE data for a
selected drug, CMS will use AMP data reported by manufacturers to
determine whether bona fide marketing is occurring when the agency
undertakes the process of deselecting a selected drug and monitoring
for the continued bona fide marketing of a generic drug or biosimilar.
CMS will consider an approved generic drug or licensed biosimilar
biological product to be marketed when the totality of the
circumstances, including these data, reveals that the manufacturer of
the generic drug or biosimilar biological product is engaging in bona
fide marketing of that drug or product.
Question. As CMS has acknowledged, certain shifts in the structure
of the Part D program, as codified under the IRA, will likely
accelerate trends toward more assertive applications of utilization
management, as well as additional growth in formulary exclusions and
hikes in beneficiary cost-sharing rates.
These mechanisms, if improperly executed, can result in
inappropriate pharmacy-counter rejections, as HHS OIG has noted in a
number of reports. Moreover, both formulary exclusions and high out-of-
pocket costs can substantially depress medication adherence, hindering
health outcomes for seniors and driving up medical costs elsewhere in
the health-care system. Broad plan exclusions of low-wholesale
acquisition cost (WAC) biosimilar alternatives to Humira present a case
in point, as beneficiaries continue to incur inflated-list-price-based
coinsurance for branded Humira or high-WAC biosimilars, sometimes
abandoning their prescriptions altogether and suffering avoidable
adverse reactions as a result.
What specific steps has CMS taken, and does the agency plan to
take, to ensure a sufficiently robust formulary review process that
requires clinically appropriate decision-making and meaningful P&T
committee engagement in the development process, in accordance with
existing statutory, regulatory, and subregulatory requirements?
Can you commit to issuing guidance or other forms of regulatory or
subregulatory action to clarify the agency's consideration of factors
like cost-sharing (i.e., when evaluating plan selection of higher-cost
versions of therapeutically equivalent products), utilization
management protocols, and other formulary structures in reviewing
formularies for compliance with general requirements, as well as with
beneficiary protections against practices likely to discourage
enrollment by certain groups of patients, such as those who utilize
high-list-price/high-rebate products but face unduly high cost-sharing
obligations that fail to account for rebating?
Does the agency plan to undertake any transparency efforts with
respect to oversight and enforcement in terms of formulary design and
utilization management regulatory and subregulatory compliance, given
the implications of inappropriate or violative practices for
beneficiary plan selection?
Answer. CMS is continuing to work to improve the Medicare Advantage
and Part D prescription drug programs and maintain high-quality health-
care coverage choices for all Medicare enrollees.
CMS maintains, and will continue to maintain, a robust clinical
formulary review process to ensure that all Medicare Part D plans meet
applicable formulary requirements. Consistent with the requirements at
Sec. Sec. 423.120(b)(2) and 423.272(b)(2)(i), CMS evaluates formularies
based on the sufficiency of categories and classes, tier placement, and
utilization management restrictions. This review process is based in
part on section 1860D-11(e)(2)(D)(i) of the Social Security Act, which
authorizes CMS to approve a prescription drug plan only if the agency
``does not find that the design of the plan and its benefits (including
any formulary and tiered formulary structure) are likely to
substantially discourage enrollment by certain Part D eligible
individuals under the plan.'' In addition, under Sec. 423.272(b)(2)(i),
``CMS does not approve a bid if it finds that the design of the plan
and its benefits (including any formulary and tiered formulary
structure) or its utilization management program are likely to
substantially discourage enrollment by certain Part D eligible
individuals under the plan.'' Furthermore, Sec. 423.120(b)(2)(iii)
requires each Part D plan formulary to ``include adequate coverage of
the types of drugs most commonly needed by Part D enrollees, as
recognized in national treatment guidelines.'' In addition,
Sec. 423.120(b)(1)(v) requires that in making decisions about formulary
design, the entity designing the formulary must base ``clinical
decisions on the strength of scientific evidence and standards of
practice.''
Additionally, CMS requires Part D sponsors to submit utilization
management requirements applied at point of sale, such as prior
authorization, step therapy, and quantity limits not based upon the
FDA's maximum daily dose limits, as part of their Health Plan
Management System formulary submission. Sponsors must perform adequate
oversight of their PBMs and other delegated entities to verify that
they are complying with all CMS requirements and not causing
beneficiary harm due to impermissible delayed or denied access to Part
D drugs.
We will continue to monitor year-over-year formulary and
utilization management changes to assess if changes from the redesigned
Part D benefit have the potential to reduce access to vital
medications.
______
Questions Submitted by Hon. Debbie Stabenow
Question. In a September 2023 Finance Health Care Subcommittee
hearing on ``Aging in Place: The Vital Role of Home Health in Access to
Care,'' witnesses testified that the current Home Health Prospective
Payment System, implemented in 2020, has led to cuts to home health
that threaten access to these vital services for patients nationwide.
These cuts particularly threaten access to care for patients in rural
communities. The President's budget includes a proposal to convert the
expanded Home Health Value-Based Purchasing Model into a permanent
Medicare program.
How will this proposal help protect access to home health services
for patients, and what other actions can Medicare take to support and
expand home health services?
In addition to facing uncertainty due to the Medicare payment
system, home health agencies face ongoing challenges due to the
workforce shortages impacting the entire health-care sector. Home
health agencies face increased difficulties recruiting and retaining
staff due to the shortage of nurses and aides that provide care in the
home.
What actions is the Centers for Medicare and Medicaid Services
taking to increase certainty and stability for home health providers?
Answer. The Home Health Value-Based Purchasing Model, which the CMS
Innovation Center launched in 2016 and expanded nationwide in 2022,
successfully improved the quality of home health care at lower cost
without evidence of adverse risks. The FY 2025 Biden-Harris budget
proposal would convert the expanded model into a permanent Medicare
program, similar to value-based purchasing programs already in place
for other Medicare providers.
The original Home Health Value-Based Purchasing (HHVBP) Model
provided financial incentives to home health agencies for quality
improvement based on their performance relative to other agencies in
their State. The HHVBP Model aimed to improve the quality and
efficiency of home health services to Medicare beneficiaries. CMS first
adjusted Medicare payments by up to 3 percent in 2018.
Payment adjustments increased each year, peaking at up to 7
percent in 2021, the last year of the original HHVBP Model prior to the
nationwide expansion of the model in January 2023.
With respect to Medicare payment rates, CMS updates the rates it
pays to home health agencies (HHAs) for providing home health services
annually as the statute requires. The Calendar Year (CY) 2024 final
rule finalized routine, statutorily required, updates to the home
health payment rates for CY 2024. CMS estimates that Medicare payments
to HHAs in CY 2024 will increase in the aggregate by 0.8 percent, or
$140 million, compared to CY 2023.
______
Questions Submitted by Hon. Chuck Grassley
Question. I am a supporter of more transparency, and I am glad the
Department of Health and Human Services (HHS) has continued Trump
administration rules to require price transparency from hospitals and
insurance companies. More needs to be done. We know that 47 percent to
65 percent of hospitals are not fully complying. I am working with
Senators Braun and Sanders to ensure actual prices, not estimates, are
listed and payers have access to their data.
Can you explain to me why 65 percent of hospitals are not
complying, yet CMS has only fined 14 hospitals?
Please do not tell me you're robustly enforcing the law when you
have only fined 14 hospitals.
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. The hospital price transparency regulation
became effective January 1, 2021, and requires each hospital operating
in the United States to make public its standard charges for the items
and services it provides. After significant outreach and technical
assistance to hospitals, hospitals have made substantial progress since
the hospice price transparency regulation went into effect in January
2021.
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. Between September
and November 2022, CMS conducted website assessments of 600 hospitals
randomly sampled from Homeland Infrastructure Foundation-Level Data. Of
the 600 acute-care hospitals sampled for the 2022 analysis, 493 (82
percent) posted a consumer-friendly display that met the consumer-
friendly display website assessment criteria, 490 (82 percent) posted a
machine-readable file that met the website assessment criteria, and 421
(70 percent) did both. The results of this website assessment suggest
that there has been substantial progress in hospitals' implementation
efforts since the Hospital Price Transparency regulation first went
into effect, although approximately 30 percent of hospitals must still
do more to achieve full compliance. 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.
In the CY 2024 Hospital Outpatient Prospective Payment System
(OPPS), CMS finalized policies to strengthen compliance and improve the
public's understanding and automated use of hospital information. CMS
finalized a requirement for hospitals to display their standard charge
information by conforming to a CMS template layout, data
specifications, and data dictionary. These changes will increase
standardization to help deliver on the promise of hospital price
transparency, improve hospitals' ability to comply, enhance the
public's ability to aggregate information (for example, for use in
consumer-friendly displays), and streamline CMS's ability to enforce
the requirements. Additionally, CMS finalized several regulatory
additions and modifications to its enforcement provisions to improve
CMS enforcement capabilities and increase transparency. These include
submission of certification by an authorized hospital official as to
the accuracy and completeness of the data in the machine-readable file
and submission of additional documentation as needed to determine
hospital compliance; submission of an acknowledgement of receipt of the
warning notice in the form and manner and by the deadline specified;
notification to health system leadership of compliance action; and
publication on the CMS website CMS's assessment of a hospital's
compliance, any compliance action taken and the status or outcome of
such action, and notifications sent to health system leadership.
As of September 2023, CMS had issued approximately 989 warning
notices and 631 requests for CAPs since the initial regulation went
into effect in January 2021. Approximately 346 hospitals were
determined by CMS after a comprehensive compliance review to not
require any compliance action and approximately 738 hospitals received
a closure notice from CMS after having addressed deficiencies indicated
in a prior warning notice or a request for a CAP following an initial
comprehensive compliance review. At the time of the publication of the
CY 2024 OPPS/ASC proposed rule, we had imposed civil monetary penalties
(CMPs) on four hospitals and publicized those CMP impositions on our
website.
Question. I have been a consistent advocate for pharmacy benefit
manager (PBM) transparency and accountability. While there is a lot
Congress should do, changes to the Medicare Part D direct and indirect
remuneration (DIR) fee clawback was a step in the right direction.
These changes should not create cash flow challenges for rural
pharmacies. At my urging, CMS used its bully pulpit last year and put
PBMs on notice to protect rural pharmacy access during these changes.
Can you update me on the efforts CMS has taken since the beginning
of the year to protect rural pharmacies? Have you put any PBMs on
notice?
Answer. Section 1860D-11(i) of the Social Security Act generally
prohibits CMS from interfering in negotiations between drug
manufacturers, pharmacies, and prescription drug plan sponsors or from
instituting a price structure for the reimbursement of covered Part D
drugs. Consequently, CMS cannot prohibit PBMs from charging any
retroactive DIR fees.
Nonetheless, we continue to encourage Part D plan sponsors to work
with pharmacies to address cash flow concerns. On November 6, 2023, we
published a memorandum to all Part D plan sponsors via CMS's Health
Plan Management System (HPMS) titled ``Application of Pharmacy Price
Concessions to the Negotiated Price at the Point of Sale Beginning
January 1, 2024,'' \6\ which reiterates and emphasizes several key
points related to this issue that CMS also stated in the Medicare
Program; Contract Year 2023 Policy and Technical Changes to the
Medicare Advantage and Medicare Prescription Drug Benefit Programs
final rule (87 FR 27704). Within this memo, we strongly encouraged Part
D plan sponsors to consider options such as payment plans or alternate
payment arrangements in advance of the January 1, 2024, effective date.
CMS additionally emphasized that Part D plan sponsors must meet the
prompt payment requirements at Sec. 423.520 and pharmacy access
standards at Sec. 423.120.
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\6\ https://www.cms.gov/about-cms/information-systems/hpms/hpms-
memos-archive-weekly/hpms-memos-wk-2-november-6-10.
More recently, we reiterated these points in our December 14, 2023,
``CMS Letter to Plan Sponsors and Pharmacy Benefit Managers,'' which
identified several concerns about practices by some plans and PBMs that
threaten the sustainability of pharmacies and impede access to care. We
encouraged plans and PBMs to work with pharmacies to alleviate these
issues and safeguard access to care. To view this letter, please visit
here: https://www.cms.gov/newsroom/fact-sheets/cms-letter-plans-and-
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pharmacy-benefit-managers.
CMS will use existing monitoring and enforcement operations to
ensure that Part D plan sponsors comply with the access requirements
prescribed in Sec. 423.120 and prompt payment requirements in
Sec. 423.520. CMS conducts quarterly analyses of all Part D plan
sponsors' networks for the contract year to identify Part D plan
sponsors that are not meeting the pharmacy access standards as required
by Sec. 423.120(a)(1). Part D plan sponsors that do not meet the
standards will receive compliance actions, where the level of the
compliance action escalates when there is repeated noncompliance in
consecutive quarters. CMS monitors the status of Part D sponsors'
complaints from beneficiaries and providers, such as pharmacies. Prompt
payment or pharmacy access violations that come to CMS's attention can
result in a compliance action.
We are committed to ensuring beneficiaries have access to necessary
health services. We value the critical role pharmacies play in health-
care delivery and recognize that we must address the needs of
pharmacies to serve our beneficiaries effectively. We will continue to
engage with stakeholders and consider policies for inclusion in future
rulemaking that would lower prescription drug costs for beneficiaries,
address challenges that pharmacies face, and improve the quality of
pharmacy care.
Question. I am glad CMS is implementing the 1,000 graduate medical
education slots I helped add as then-chairman of the Finance Committee
in 2020. However, I am concerned about the lack of slots going to rural
communities. The law requires CMS to distribute 10 percent of slots to
rural hospitals. CMS has told me in writing they intend to meet this
threshold over a 5-year period. I realize CMS can only award slots
based on applications submitted, but the agency can do a better job
educating potential applicants. We know exposure to rural health care
during a medical student's residency is associated with a greater
likelihood of practicing in a rural area.
Can you have CMS follow-up with me between now and the end of the
month on specific actions it's taken to educate rural applicants since
July 2023?
The deadline to apply for the next 200 slots is March 30, 2024, so
it's important I understand what actions the agency has taken since
last summer.
Answer. The training and retention of physicians are both critical
to ensuring access to health care in underserved and rural communities
that historically have experienced workforce challenges.
To support rural hospitals, CMS has worked in conjunction with the
Health Resources and Services Administration's (HRSA's) Office of Rural
Health Policy to educate potential applicants about the section 126
application process. On February 13, 2023, and January 17, 2024, CMS
participated with HRSA and the Rural Residency Planning and
Development--Technical Assistance Center in webinars aimed at educating
potential rural applicants about the section 126 application process.
CMS has also participated in the rural health and hospital open door
forums and is committed to providing timely and accessible responses to
anyone who submits a question through our section 126 email inbox at
CAA126application@cms.hhs.gov. In addition, background information
regarding the section 126 application process and frequently asked
questions are posted on CMS's Direct Graduate Medical Education
website.
Question. The President has announced a ``strike force'' to ease
health-care costs.
Are you aware that HHS has finalized over 85 health-care
regulations since 2021 that have imposed over $23 billion in costs to
patients, providers, and taxpayers?
Answer. The Biden-Harris administration has delivered health care
to millions more Americans while also lowering health-care costs. The
administration continues to build on, strengthen, and protect Medicare,
Medicaid, and the Affordable Care Act, including through the American
Rescue Plan Act and the Inflation Reduction Act to lower prescription
drug costs in Medicare and health insurance premiums for marketplace
consumers. As a result of these efforts, more Americans have health
insurance than under any other administration and are better protected
against surprise medical bills and junk fees. Individuals with Medicare
are already seeing lower prescription drug prices with insulin cost
sharing capped at $35 per covered product per month's supply, no out-
of-pocket costs for certain recommended vaccines under Medicare Part D,
and annual Medicare Part D out-of-pocket costs for prescription drugs
capped at $2,000 in 2025. The administration is well on its way to
lowering the cost of drugs as Medicare negotiates the prices of certain
high-expenditure prescription drugs for the first time ever. The Biden-
Harris administration has also taken steps to make sure consumers
aren't scammed by junk insurance and have better access to mental
health care.
Question. In December 2022 and October 2023, I wrote to you about
concerns that HHS had prioritized speed over the safe processing of
Unaccompanied Alien Children (UAC), which includes serious failures in
the sponsor vetting process.\7\ Although your Assistant Secretary for
Legislation provided a letter on March 13, 2024, supposedly in response
to my letters, the responses were insufficient. It is important that
HHS provide Congress with sufficiently detailed information and
requested records so that we may conduct thorough and independent
oversight of the Office of Refugee Resettlement, its vetting process,
and the disastrous effect its failed processes have had on innocent
children.\8\ Accordingly, I ask that you respond to the requests below,
and I once again reiterate the unanswered information requests from my
previous letters.\9\
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\7\ Letter, Senator Charles E. Grassley, Ranking Member, Committee
on the Judiciary, to the Hon. Xavier Becerra, Secretary, Department of
Health and Human Services (December 12, 2022), https://
www.grassley.senate.gov/download/grassley-to-dept-of-health-and-human-
services
_-uac-placements; letter, Senator Charles E. Grassley, Ranking Member,
Senate Budget Committee, to the Hon. Xavier Becerra, Secretary,
Department of Health and Human Services (October 12, 2023), https://
www.grassley.senate.gov/imo/media/doc/grassley_to_hhs_-_uac_sponsor
_vetting.pdf.
\8\ Letter, Assistant Secretary for Legislation, Melanie Anne
Egorin, Ph.D., to Senator Charles E. Grassley, Ranking Member,
Committee on the Budget (March 13, 2024), on file with committee staff.
\9\ Letter, Senator Charles E. Grassley, Ranking Member, Committee
on the Judiciary, to the Hon. Xavier Becerra, Secretary, Department of
Health and Human Services (December 12, 2022), https://
www.grassley.senate.gov/download/grassley-to-dept-of-health-and-human-
services
_-uac-placements; letter, Senator Charles E. Grassley, Ranking Member,
Senate Budget Committee, to the Hon. Xavier Becerra, Secretary,
Department of Health and Human Services (October 12, 2023), https://
www.grassley.senate.gov/imo/media/doc/grassley_to_hhs_-_uac_sponsor
_vetting.pdf.
For sponsors who claim to be a relative or parent of the child,
please provide data for what percentage of potential sponsors have been
determined to have made a false claim of family relationship, and
describe what steps were taken in those instances to punish these
---------------------------------------------------------------------------
individuals for making a false claim or providing false documents.
Answer. HHS's Office of Refugee Resettlement's (ORR) sponsor
suitability assessment process includes verifying the sponsor's
relationship to the child. This is accomplished by speaking with the
child's parents when possible, conducting separate interviews with the
child and sponsor, and collecting supporting documentation to verify
the sponsor's information. For the child's safety, the process also
administers background and address verification checks, which include
public records and sex offender registry checks, as well as FBI
fingerprint checks in certain cases. The potential sponsor must provide
at least one form of evidence of the relationship they claim to have
with an unaccompanied child, such as a birth certificate, marriage
certificate, death certificate, court records, guardianship records,
hospital records, schools records, or a written affirmation of
relationship from a Consulate. Voluntary DNA testing is used for
sponsors and unaccompanied children to establish biological
relationships when other proof of relationship is unavailable or
unverifiable.
During the period of January 21, 2021, through January 23, 2024,
ORR received 401,288 sponsor applications for unaccompanied children.
Within this time period, ORR denied 7,926 potential sponsor requests,
and 7,966 potential sponsors withdrew from consideration.
Question. Your March 13, 2024, response letter states that on
February 13, 2024, ORR published policy and procedure revisions to its
sponsor vetting requirements. Those revisions appear to include the
reintroduction of background check requirements for Category 2
potential sponsors, including immediate family relatives, potential
sponsors' adult household members and adult caregivers. According to
your response, these revisions supersede ORR issued Field Guidance #11,
which ended background check requirements for most Category 2 sponsors
for nearly 3 years.\10\
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\10\ Department of Health and Human Services, Administration for
Children and Families, Office of Refugee Resettlement, Field Guidance
#11, Temporary Waivers of Background Check Requirements for Category 2
Adult Household Members and Adult Caregivers (March 31, 2021), https://
www.acf.hhs.gov/sites/default/files/documents/orr/FG-
11%20Temporary%20Waiver%2
0of%20Background%20Check%20Requirements%202021%2003%2031.pdf.
Please provide all records, including data and analysis compiled by
HHS, on how Field Guidance 11 impacted the safety of unaccompanied
alien children, and how this data was used to reinstate background
check requirements for all category 2 sponsors.\11\
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\11\ ``Records'' include any written, recorded, or graphic material
of any kind, including letters, memoranda, reports, notes, electronic
data (emails, email attachments, and any other electronically created
or stored information), calendar entries, interoffice communications,
meeting minutes, phone/voice mail or recordings/records of verbal
communications, and drafts (whether or not they resulted in final
documents).
What processes does ORR have in place to ensure that these recently
reintroduced background checks and requirements are followed during the
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vetting and placement process?
Why did HHS ORR decide to reinstate these background checks, and
was any assessment conducted to determine the impact of the removal of
background check requirements in the previous Field Guidance #11 on the
safety and well-being of unaccompanied children?
Answer. ORR continuously reviews its sponsor vetting requirements
and assessment processes and develops and refines policies, procedures
and practices to further streamline and strengthen the screening of
sponsors, without sacrificing child safety or unduly extending the time
children remain in ORR's care. The latest changes reflect ORR's ongoing
commitment to prioritize child welfare and safety while minimizing the
time children spend in congregate care settings--consistent with child
welfare best practices and ORR's legal obligation to place children
without undue delay. The updated policies build upon longstanding
vetting procedures as well as operational and technological
improvements within the Unaccompanied Children (UC) Program. These
changes improve the verification process, strengthen home study
policies and guidance, incorporate child welfare outcomes and
sponsorship history, expand background check requirements, and ensure
third-party review for all cases.
This administration inherited a significantly underresourced UC
Program with less than half of the needed shelter capacity in 2021. The
prior administration imposed a months-long hiring freeze on ORR and its
grant recipients, severely restricting the capacity to serve children
referred to ORR care and address the needs of the UC Program in 2021.
In FY 2020, ORR's bed capacity was insufficient to serve even 8,000
children in care. As of March 2024, ORR has updated its infrastructure
to have a standard network capacity with more than 12,000 beds and the
ability to activate influx care facilities more quickly, so that ORR
can care for all children referred to its custody. In addition to
drastically expanding its capacity to serve unaccompanied children, ORR
has made multiple improvements to its case management system,
including: modernizing the UC Portal--the UC Program's data system--
with child safety improvements, such as standardizing addresses and
sponsor's names and making it easier to identify and flag potential
child welfare concerns during sponsor suitability assessments and aid
case managers in making informed decisions regarding home studies; now
providing 7-day-a-week case management for family unification services;
entering into Memoranda of Agreement with the Office of Trafficking in
Persons (OTIP), National Center for Missing and Exploited Children
(NCMEC), a nonprofit organization established by Congress, and the
Department of Labor (DOL); and expanding access to post-release
services (PRS) to children released from ORR care from just over 20
percent in FY 2021, to offering access to PRS to approximately 59
percent of children released from ORR care in FY 2023.
Question. Please provide in detail all policies HHS has in place to
ensure the safe handling of children by government contractors and
grantees, including temporary housing for UACs and transferring
children to sponsors. In responding to this request, name what steps
HHS takes to ensure children are able to report instances of abuse by
Federal contractors and grantees and are informed of the processes in
place to safely file those reports.
In responding to this request, please also provide data for reports
of abuse at any UAC housing facility since January 1, 2022, broken down
by facility and sorted by date;
Provide a copy of all contracts for UC care providers, and the
costs for each Federal contract, including subcontracts.
Are there any instances in the past five years where contract
employees have had access to children without or before completing
criminal background checks? If so, which contractors, and why was this
allowed?
Answer. HHS and ORR have a zero-tolerance policy for all forms of
abuse and maltreatment and have implemented a number of safeguards
designed to protect unaccompanied children in ORR facilities. ORR
requires all care providers to report incidents affecting a child's
health, well-being, and safety. Care providers must report on a wide
range of incidents from behavioral incidents to allegations of sexual
abuse, via Significant Incident Reports (SIRs) as described in UC
Program Policy Guide Section 5.8. SIRs are filed for a variety of
reasons in accordance with policy and procedure, including to document
observations that may not necessarily affect immediate health and
safety but that are valuable for enabling ORR care providers to meet
children's individualized needs; to document allegations of sexual
harassment or abuse, physical abuse, and child neglect; and to document
threats to children from traffickers or criminal actors or other acts
of fraud, and serious health or mental health issues. Following any
report of abuse, ORR ensures that care provider facilities: (1) report
the allegation to the appropriate investigative authorities, such as
child protective services, the State licensing authority, local law
enforcement, HHS's Office of Inspector General, and/or the Federal
Bureau of Investigation (FBI); (2) cooperate with any investigation of
the allegation; and (3) take immediate action to protect the victim and
the safety of other children at the facility--such as separating the
victim from the perpetrator, increasing supervision, housing changes,
and/or transfers.
In accordance with UC Program Policy Guide Section 4.3.8, any care
provider contractor or volunteer accused of sexual harassment or sexual
abuse is immediately suspended until investigation of the incident is
completed by the relevant authorities. Such incidents will result in
termination if allegations are substantiated. Further, per UC Program
Policy Guide Sections 4.7 and 4.10.1, ORR provides multiple, easily
accessible methods for children and youth to report sexual abuse,
sexual harassment, inappropriate sexual behavior, and staff Code of
Conduct violations. Care providers must inform all children of policies
for preventing, detecting, and responding to sexual abuse and sexual
harassment, and the care provider's policies and procedures must
include provisions for staff to accept and respond to such reports.
All staff, including contractors, grant recipients, and deployed
Federal volunteers, are required to undergo thorough background checks,
even during times of an increased number of children referred to ORR's
custody. All personnel working with ORR must be compliant with all
Federal child-care services background check requirements and ORR's
employee background investigation policy, and must pass public record
criminal background, sex offender, and State Child Abuse and Neglect
(CA/N) checks. Care providers must also meet State licensing
requirements. In addition, ORR has new procedures in place to help care
providers navigate circumstances in which CA/N check results are
delayed or impossible to obtain. Given that some CA/N check results
take longer than 30 days or the relevant State(s) do not provide CA/N
check results, ORR care providers are permitted to onboard prospective
personnel (staff, contractors, and volunteers) on a provisional basis
and subsequently transition them off of their supervision plan during
the pendency of CA/N checks only when certain conditions are met.
Personnel must complete all requirements for working under supervision
for 30 days and then ORR may approve the care provider's request to
transition the individual off of the supervision plan. This is further
outlined in UC Bureau Policy Guide, Section 4.3.3.2. ORR routinely
monitors its care providers' policies and procedures to assess the
documentation and adherence to required background checks, the
frequency of checks, and the roles and responsibilities of individuals
involved in the process.
The response to Question #31 below includes the ORR grant
recipients and contract vendors from January 1, 2021, through March 14,
2023. Additional information regarding grants and contracts are
available on https://sam.gov/ and https://grants.gov/.
Question. Please describe in detail all processes ORR has in place
to follow up with UACs after placement with sponsors, and provide data
broken into the following categories for sponsors placed by ORR since
January 1, 2022 (divided by month):
The total number and percentage of 30-day wellness check calls
made;
The total number and percentage of wellness check calls answered
and not answered, in absolute numbers and as a percentage of total
unique calls attempted;
If the number of unique calls attempted is less than the total
number UACs placed with sponsors in a given month, an explanation for
the discrepancy;
Provide a copy of HHS's written policies and procedures detailing
steps taken if wellness check calls are unanswered and contact cannot
be made with sponsors after the first attempt; and
Provide all records related to all actions HHS has taken to
reestablish contact with children whose sponsors failed to answer these
wellness check calls.
Answer. While ORR's custodial responsibilities end when a child is
discharged, ORR has policies in place to promote children's well-being
as they transition into a new community, providing children with
multiple ways to connect with ORR or community support services
following their sponsor placement, such as through safety and well-
being calls, post-release services, legal services, or the 24/7 ORR
National Call Center (ORRNCC), which connects children and sponsors
with community resources and is required to report all safety concerns
identified by callers to ORR and other Federal, State, and/or local
entities. While safety and well-being call data since FY 2023 shows
that ORR has been able to make contact with a child, the sponsor, or
both in 83 percent of these follow-up calls--which are voluntary for
children or their sponsors to participate in--safety and well-being
calls are just one of the variety of ways for children to be connected
to additional community supports. In fact, ORR has expanded PRS to a
historic level, and ORR is committed to expanding access to PRS even
further to include all children by the end of FY 2024, as
appropriations allow. Notably, ORR does not have the authority to
remove a child from a home--that authority resides with law enforcement
and State child welfare agencies. ORR recognizes the critical
importance of its coordination and engagement with these agencies.
Per ORR's UC Program Policy Guide section 2.8.4, care providers
must conduct a safety and well-being follow-up call with an
unaccompanied child and their sponsor 30 days after the release date.
The purpose of the follow-up call is to determine whether the child is
still residing with the sponsor, is enrolled in or attending school, is
aware of upcoming court dates, and is safe. The care provider must
document the outcome of the follow-up call in the child's case file,
including if the care provider is unable to contact the sponsor or
child after reasonable efforts have been exhausted. If the follow up
call indicates that the sponsor and/or child would benefit from
additional support or services, the care provider must refer the
sponsor or child to the ORRNCC and provide the sponsor or child the
ORRNCC contact information. If the care provider believes that the
child is unsafe, the care provider must comply with mandatory reporting
laws, State licensing requirements, and Federal laws and regulations
for reporting to local child protective agencies and/or law
enforcement. Additional information regarding required reporting of
events related to an unaccompanied child's safety and well-being is
available in UC Program Policy Guide section 5.8.
Question. In an October 6, 2023, ``Fact Sheet'' released by ORR it
claimed that, ``[a]s a part of the placement process, potential
sponsors must undergo a criminal public records check, and in most
cases, a sex offender registry check. When there is a safety concern
for release to a related sponsor or when considering release to an
unrelated sponsor, ORR also conducts background checks on adult
household members and individuals identified in a potential sponsor's
care plan.''\12\
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\12\ Department of Health and Human Services, Administration for
Children and Families, Office of Refugee Resettlement, ORR Influx Care
Facilities for Unaccompanied Children Fact Sheet (October 6, 2023),
https://www.acf.hhs.gov/sites/default/files/documents/orr/icf-uc-fact-
sheet.pdf.
Please describe any exceptions to sponsors being required to
undergo criminal public records checks, and the numbers of sponsors who
have not undergone such background checks as a percentage of total
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sponsors by sponsorship category.
Please describe what cases do not require a sex offender registry
check, and the reasons for this omission, as well as documentation of
any changes in procedure made since 2021.
Please describe and provide all written policies for how ORR
determines whether or not there is a ``safety concern'' about a related
sponsor and the total number of identified household members who have
not been subject to a background check, broken down by year since this
policy was changed.
For background check results, provide a numerical breakdown of all
hits within the criminal and sex offender category.
Does HHS take any steps to determine if a sponsor is connected to a
cartel or other organization involved in transnational organized crime?
If so, please describe those steps, to include interaction with other
government agencies and database searches, as well as how that
information is shared between agencies and whether HHS is notified by
other agencies if they have information relevant to UAC sponsors.
How many potential sponsors have been identified as connected to
cartels? Has HHS ever placed a UAC with a sponsor where available
information showed the sponsor may be connected to a cartel? If so,
when and how many times?
Please provide your written policies and any data you have
collected concerning release of UACs to unrelated sponsors and the
safety of those placements.
Provide all records documenting any instructions you have made to
ORR or any other person or component within HHS requesting they
expedite processing of UACs, and all records documenting any concerns
expressed about those instructions by anyone, including contractors or
HHS employees.
Answer. ORR has thorough sponsor screening and vetting processes in
place for each category of sponsor. These categories are for parents or
legal guardians (Category 1), or other specified family members
(Category 2), as well as more distant relatives or unrelated sponsors
(Category 3), often identified by the child's parent. ORR's process for
the safe and timely release of a child from Federal custody includes
several steps such as: separate interviews with the child and sponsor
and with the child's parents, if available; a sponsor application;
address checks, and requirements for supporting documentation;
background checks including public records and sex offender registry
checks; and in some cases, FBI fingerprint checks; as well as home
studies as required in certain circumstances by the William Wilberforce
Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA), or
mandated by ORR policy. Additional details on this process are
available in ORR's UC Program Policy Guide Section 2: Safe and Timely
Release from ORR Care.
Per ORR policy, a public records check and sex offender registry
check is required for potential sponsors in all categories. ORR also
requires FBI fingerprinting for certain immediate relatives who were
not previously the child's primary care giver and nonrelative sponsors.
ORR may also require FBI fingerprinting for parents, legal guardians,
immediate relatives who previously cared for the child, and nonsponsor
adult household members and adult caregivers identified in a sponsor
care plan in certain cases, such as when the public records check
reveals possible disqualifying factors; where there is a documented
risk to the safety of the unaccompanied child; the child is especially
vulnerable; and/or the case is being referred for a home study.
ORR requires a background check search of State CA/N registries
maintained by individual States for certain cases, such as for
potential sponsors in any category where a special concern is
identified. In cases where a sponsor is required to undergo a CA/N
check, all non-sponsor adult household members and adult caregivers
identified in a sponsor care plan generally must receive the CA/N
checks.
In accordance with UC Program Policy Guide section 2.5.1, Category
3 potential sponsors, which include distant relatives and unrelated
sponsors, must undergo a public records background check of criminal
history and sex offender registry databases, as well as a fingerprint
background check processed through the FBI. Category 3 nonsponsor adult
household members and adult caregivers identified in a sponsor care
plan must also undergo a public records background check of criminal
history and sex offender registry databases, as well as an FBI National
Criminal History Check in certain cases. In cases that require a home
study or where a special concern is identified, Category 3 potential
sponsors must also undergo a CA/N check.
ORR continuously reviews its vetting policies and procedures for
ways to improve its processes to promote the safety and well-being of
children and to be more efficient and effective. For instance, on June
2, 2023, HHS released the results of its audit of the vetting process
for potential sponsors who have previously sponsored an unaccompanied
child, to ensure all necessary safeguards are in place without
unnecessarily keeping children in government-funded, congregate care
settings.
On February 13, 2024, ORR published policy and procedure revisions
that enhance its sponsor vetting requirements. Among other
enhancements, these revisions require parents and legal guardians
(Category 1) sponsors to provide proof of address documentation
(already a requirement for all other sponsors) and also requires, at
minimum, sex offender registry checks for all adult household members
and adult caregivers, including in Category 1 cases. The revisions also
require, at minimum, proof of identity and criminal history public
records background checks for all adult household members and adult
caregivers, with a narrow exception for certain Category 1 cases such
as where there are no safety concerns. These recent revisions also
strengthen and expand home study policies and guidance to include
mandatory home studies for potential sponsors of more than two
children, regardless of the potential sponsor's relationship to the
children. The February 2024 policy revisions supersede Field Guidance
10, 11, and 15. Additional information on sponsor vetting can be found
in UC Program Policy Guide Section 2.
Question. According to a report by The New York Times, citing
``five people familiar with the call,'' you told Ms. Cindy Huang, then
ORR Director, that, ``if she could not increase the number of
discharges [of UACs], [you] would find someone who could,'' and that
you ``made a similar threat to her successor.''\13\ Are these reports
true? If so, why did you issue these instructions, and what specific
steps did you order to prevent the increased processing pace from
endangering the safety of UACs? Please provide all records documenting
those instructions.
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\13\ New York Times, supra n. 13.
Provide a list of all employees who were transferred, terminated,
or threatened with any adverse action after expressing any feedback
concerning the ORR vetting process or concerns about any aspect of ORRs
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placement of UACs.
Provide the name and personnel file for the employee referenced in
the Florida grand jury report, who was ``fired for reporting a case of
suspected human trafficking (of over 100 UAC shipped off to a single
house in Texas) to a government hotline because her ORR superiors
refused to investigate the matter.'' When responding to this request,
include all records related to the underlying matter, including the
names of the HHS supervisors the employee reported the matter to, the
entire file related to any internal investigation conducted, and all
records related to their response to these reports.
Answer. HHS is committed to upholding the legal rights of and
protecting whistleblowers, including by ensuring its policies abide by
all applicable whistleblower protections statutes and reporting
directives in annual Federal funding laws. Whistleblower protections
are a key mechanism for ensuring the safety and well-being of all
children in ORR care and the staff providing such care. HHS and ORR do
not tolerate any threats or retributory actions against whistleblowers.
Any time ORR becomes aware of information that could impact the
safety of children, it conducts a review and puts additional safeguards
in place if needed. In addition to HHS's mandatory supervisory
whistleblower trainings, ACF has worked closely with HHS OIG to provide
additional mandatory whistleblower trainings for all ACF staff,
including ORR staff, and ORR has also worked with OIG to provide
additional trainings for ORR grant recipients and contractors.
Questions regarding specific whistleblower complaints are best
directed to HHS OIG as the division that handles such claims should a
whistleblower choose to file a report.
Question. At the hearing, you were asked about a February 2024 HHS
Office of Inspector General (OIG) report which found that ``Gaps in
Sponsor Screening and Follow-up Raise Safety Concerns for Unaccompanied
Children.''\14\ In your response, you stated that, ``I can assure you
that most of the recommendations that were made by the Inspector
General for incidents you are referring to, incidents that occurred
back in Spring of 2021, a 2 or 3 month period, I can assure you that
what was being observed by the Inspector General back then is not the
case today. If you recall, at that point we had an infrastructure that
had been virtually dismantled . . . and at that point we were dealing
with an influx of children.''\15\ Documents in my possession show HHS
even created a ``UCMigration'' email address in 2021 for employees to
report potential trafficking flags to HHS's Administration for Children
and Families (ACF), which further shows HHS was aware of potential
trafficking in the program by at least July 2021.
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\14\ Department of Health and Human Services, Office of the
Inspector General, ``Gaps in Sponsor Screening and Follow-up Raise
Safety Concerns for Unaccompanied Children'' (February 15, 2024),
https://oig.hhs.gov/oei/reports/OEI-07-21-00250.asp.
\15\ U.S. Senate Committee on Finance, full committee hearing,
``The President's Fiscal Year 2025 Health and Human Services Budget''
(March 14, 2024), https://www.finance.senate.gov/hearings/the-
presidents-fiscal-year-2025-health-and-human-services-budget.
When did HHS first become aware that required background checks or
other safety steps had not been conducted, and did HHS take any steps
to fix these problems and conduct the missing background checks after
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the problem was identified?
When in 2021 were you first alerted to trafficking concerns?
How many cases of potential human trafficking, abuse, or neglect,
did HHS identify in 2021? When were those identified, and who did HHS
notify with this information? Was law enforcement notified? If so,
which agencies?
Did HHS instruct contractors to omit any required sponsor or
household member background checks or other requirements of law or HHS
policy due to the ``influx'' of migrant children, and if so, when was
that instruction issued, to whom, and for what reason? If not, why did
HHS officials overseeing contractors allow these steps to be omitted?
Why did you and others at HHS repeatedly place an emphasis on the
speed of processing unaccompanied children if there was a major
``influx'' that made it difficult to accomplish the needed background
and other safety checks?
Did HHS later conduct, or contract for, any data analysis of its
placements in 2021 to determine which children were placed without
background checks or to determine whether there were any signs of
trafficking activity or other danger for those children who may have
been missed during the ``influx'' period? If so, was information about
potential trafficking or potential criminal activity referred to law
enforcement? If it was, which agencies received that information, and
what action was taken? If not, why didn't HHS take these basic steps
when it was aware a problem existed?
Please describe any actions ORR took to reestablish contact with
sponsors who UACs were released to and actions that ORR took to vet the
sponsors to ensure children were not released into dangerous
situations.
Were any of the incidents during this 2 or 3-month period covered
by the OIG report, or at any time throughout 2021, referred to law
enforcement? If so, please provide information on the number of cases
and the reason for referrals to law enforcement.
How many concerns were sent to the email address established by HHS
in July 2021, and how were they acted upon? Were suspicious sponsors
identified, and were any children removed from sponsors' homes as a
result of that information? Please provide all records related to this
email address and actions taken as a result of information obtained
through it.
Please provide all data and analysis sufficient to establish your
claim that any issues that existed in 2021 are no longer present in the
UC sponsor vetting process. This data and analysis should cover all
relevant categories related to safe placement of UACs, including
sponsor background checks, address verification, authenticity of
identity documents, sex offender registry checks, conducting of home
studies, public records searches, etc.
Answer. When ORR receives a report of suspected labor exploitation
or trafficking involving an unaccompanied child, ORR implements a range
of actions as appropriate to the situation to both respond to the
allegation and provide additional safeguards for other unaccompanied
children if applicable. These actions can include immediately halting
discharges to specific locations (utilizing street information) or
individual sponsors; mandating home studies and/or supervisory reviews
prior to case approval, which may already be required in certain cases;
conducting welfare phone calls and/or in-person visits; and flagging
for the State's child welfare agency, local law enforcement, Office on
Trafficking In Persons (OTIP), and other relevant entities for certain
locations and a geographically appropriate radius around those
locations.
All trafficking reports are provided to the Department of Homeland
Security (DHS) and OTIP. Specifically, ORR requires care providers to
notify stakeholders like DHS and OTIP of all suspected trafficking or
exploitation concerns within 24 hours. ORR and OTIP also work closely
with DOL, which provides notice to OTIP when it detects indicators of
trafficking affecting potential minors and can flag particular trends
or cases related to labor exploitation more broadly. Further, the
ORRNCC notifies local law enforcement and child welfare agencies--the
entities with the authority to determine whether to remove the child
from their current home.
HHS takes OIG recommendations very seriously and is committed to
continuing to improve the UC Program, including through efforts to
implement OIG's recommendations. Notably, ORR has already addressed
many of the concerns raised by OIG as the report focused on a specific
period, March through April 2021, during one of the most challenging
periods in ORR's history amid a historic number of unaccompanied
children placed in ORR care and at the height of the COVID-19 pandemic.
ORR continuously reviews its intensive vetting policies and procedures
for ways to improve its processes to be efficient, effective, and
ultimately promote the safety and well-being of children.
Since April 2021, when OIG's review concluded, ORR has made
substantial process improvements based on child-welfare principles to
ensure the safety and well-being of unaccompanied children through
comprehensive case management and enhanced technology, data gathering,
and analytics. For instance, ORR provides 7-day-a-week case management,
specifically for family unification services, and ORR has updated the
UC Portal, the UC Program's data system, to enhance usability and
search functionality. These updates and new features ensure that
sponsors' records are accurately and comprehensively obtained and
accessible across the entire network of care providers. The
improvements build in safeguards and make it easier to identify and
flag potential child welfare concerns during sponsor suitability
assessments and aid case managers in making informed decisions,
including regarding home studies.
In addition, in 2020, the prior administration imposed a months-
long hiring freeze on ORR and its grant recipients, severely
restricting the capacity to serve children referred to ORR care during
the time of the OIG review. Since then, ORR has increased its staffing
capacity to a level that can manage significant numbers of children in
ORR's care. ORR appreciates the support from Congress to be able to
increase staffing capacity and welcomes continued resources and
flexibilities to hire additional staff in a timely manner in the event
of another influx of unaccompanied children entering ORR care.
Question. The February 2024 OIG report found that in 35 percent of
children's case files during the time period analyzed, sponsor-
submitted IDs contained legibility concerns.\16\ According to legally
protected whistleblower disclosures to my office, HHS contractors often
use third-party apps like WhatsApp to collect these identity documents
from potential sponsors and lacked sufficient training to identify
fraudulent documents. This raises serious concerns about the steps HHS
is taking, or failing to take, to establish the identity of potential
sponsors and their alleged family relationship to unaccompanied
children. As you know, the category of the sponsor determines whether
background checks are conducted, which means robust procedures to
establish identity are critical to the safety of migrant children.
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\16\ Department of Health and Human Services, Office of the
Inspector General, ``Gaps in Sponsor Screening and Follow-up Raise
Safety Concerns for Unaccompanied Children'' (February 15, 2024),
https://oig.hhs.gov/oei/reports/OEI-07-21-00250.asp.
Has HHS permitted contractors to receive identity documents through
third-party messaging apps? If so, do they still use such apps to
collect identity documents and what steps are in place to assure the
---------------------------------------------------------------------------
documents are authentic?
What steps has HHS taken, or will it take, to assure that all files
where identity documents are partly or totally illegible are reviewed
to ensure the identity documents provided are authentic and a clear
copy is on file?
How have your policies and procedures for identifying fraudulent
documents, receiving identity documents, and establishing family
relationship based upon these documents changed since the time period
examined by the HHS OIG in its February 2024 report?
Does HHS or its contractors and grantees ever place children in the
custody of someone other than the sponsor, for example, when the child
is transported to the sponsor's custody and another person is
designated to pick up a child at an airport or bus station? If so, how
is the identity of that person established and their connection to the
sponsor?
Answer. ORR trains staff to use several robust tools to verify the
identity of potential sponsors. All potential sponsors must submit
original versions or legible copies of government-issued identification
documents.
For verification of the relationship claimed with the child, the
potential sponsor must also provide at least one form of evidence such
as a birth certificate, marriage certificate, death certificate, court
records, guardianship records, hospital records, school records, a
written affirmation of relationship from a Consulate, or other similar
documents.
If there are discrepancies or concerns that an unaccompanied child
may be using fraudulent foreign identification documents, the ORR case
manager may ask the respective consulate of the country of which the
child is a national to verify the authenticity of the identification
document and, in certain cases, to interview the child to inquire about
family history (subject to restrictions on mandatory/non-mandatory
notification contacts to countries as demonstrated in UC Program Policy
Guide section 5.4.3). The respective consulate may also be able to
provide a family tree that can be used by the ORR case manager and the
consulate during assessments and interviews to determine any
discrepancies.
Voluntary DNA testing is also used for sponsors and unaccompanied
children to establish biological relationships when proof of
relationship otherwise does not exist (e.g., when documentation is
unavailable or unverifiable). In these instances, the ORR case manager
notifies the ORR Federal Field Specialist (FFS) and the Case
Coordinator to recommend a DNA test be conducted.
If a sponsor, household member, or adult caregiver provides any
false information in the application of release and/or accompanying
documents or submits fraudulent documents for the purpose of obtaining
sponsorship of the child, ORR reports the incident to the HHS OIG. ORR
can deny release if it is determined that fraudulent documents were
submitted during the application of release process.
ORR staff supervise and escort unaccompanied children until they
are placed in the care of another ORR facility or a vetted family
member or sponsor. This transportation is coordinated, and clearly
communicated to all appropriate parties, from an ORR facility to a
vetted family member or sponsor or to another ORR facility that is
ready and awaiting the arrival of the child.
Question. At the hearing, I asked you whether HHS provides
information to law enforcement without a subpoena being required.\17\
You didn't answer my question. You instead said you work with law
enforcement, while trying to protect the privacy of children and
sponsors. Recent news reports state that reports of missing and runaway
migrant children to HHS's national call center have spiked during the
current administration from fewer than 500 in 2020 to over 2,700, more
than five times as many, in 2022.\18\ As these reports indicate, often
local authorities know nothing about unaccompanied children placed in
those communities, since they aren't notified before the placement.
Yet, when children go missing, local law enforcement often turn to HHS
for help, since HHS ORR has pictures of the children, as well as birth
certificates, medical history, demographic information, and often
contact information for family members living in the U.S. Nonetheless,
as these reports indicate, HHS is not responsive to their requests and
often fails to provide information needed to locate these children.
This is beyond unacceptable.
---------------------------------------------------------------------------
\17\ U.S. Senate Committee on Finance, full committee hearing,
``The President's Fiscal Year 2025 Health and Human Services Budget''
(March 14, 2024), https://www.finance.senate.gov/hearings/the-
presidents-fiscal-year-2025-health-and-human-services-budget.
\18\ Kristian Hernandez and Karen Rodriguez, When migrant children
disappear, many cases remain unsolved, The Center for Public Integrity
(February 23, 2024), https://publicintegrity.org/inequality-poverty-
opportunity/immigration/migrant-children-disappear-cases-unsolved/.
What specific legal or regulatory provisions does HHS believe
prevent it from sharing information that would assist law enforcement
---------------------------------------------------------------------------
in locating a missing child?
What are HHS's policies for cooperating with law enforcement when
they request information on a missing child?
Why would HHS refuse to provide information about missing
unaccompanied children to local law enforcement in a timely manner?
Answer. If ORR care provider staff, such as a case manager or
clinician, identifies or suspects any safety concerns at any point
during their interaction with an unaccompanied child either while a
child is in ORR care or post-release through a safety and well-being
call, they are required to issue a Notification of Concern to ORR and
notify appropriate investigative agencies, including local law
enforcement and child protective services. This includes any suspicion
that the child has run away, is at risk of or posing a danger to
themselves or others, or is at risk of human trafficking, exploitation,
or other abuse. ORR then conducts further review and determines what
actions should be taken, which may include additional reporting and
engagement with local law enforcement, State child welfare authorities,
and/or referral for post-release services such as timely referrals and
connection to community resources or intensive services, in cases where
additional support is needed to address a child's specific needs or
challenges. It is important to note that ORR, as a Federal agency,
cannot remove a child from a home; that authority resides with State
child welfare and law enforcement agencies. ORR recognizes the critical
importance of its notification and coordination processes to ensure
that local authorities can respond appropriately to any allegations of
abuse or neglect.
If ORR care provider staff suspect that a child is a victim of
trafficking or is at risk of trafficking at any point during their
interaction with an unaccompanied child, per ORR policy, they must make
a referral to the Department's ACF Office on Trafficking in Persons
(OTIP) and to DHS's Homeland Security Investigations (HSI) Division and
DHS's Center for Countering Human Trafficking for further
investigation. OTIP provides further assessment assistance to ensure
that victims can access appropriate care and services. Such care is
then coordinated with ORR to provide direct referrals for grant-funded
comprehensive case management services, medical services, food
assistance, cash assistance, and health insurance tailored to the
child's individual needs.
The ongoing partnership with DOL and third-party entities such as
NCMEC, as well as HHS's collaboration with other Federal, State, and
local government entities and national and community partners, are
crucial to HHS's continuous commitment to protect and respond to the
needs of unaccompanied children who may be at risk of or victims of
exploitation, including child labor exploitation. These children face
unique challenges that require a whole of government response--and HHS
takes its part in this work seriously.
ORR shares information with investigative agencies, such as local
law enforcement, in accordance with UC Program Policy Guide section
5.10, and in accordance with each respective agencies' mandate and
authority, while not releasing information that is outside the scope of
their investigation.
Question. A report from The New York Times noted that there is an
``increasing share of migrant children [who] could not be reached by
HHS after a month [from placement with a sponsor].''\19\
---------------------------------------------------------------------------
\19\ Hannah Dreier, ``As Migrant Children Were Put to Work, U.S.
Ignored Warnings,'' The New York Times (April 17, 2023), https://
www.nytimes.com/2023/04/17/us/politics/migrant-child-labor-biden.html.
What are the FY 2023 numbers for how many children could not be
---------------------------------------------------------------------------
reached by HHS after a month?
Answer. While ORR's custodial responsibilities end when a child is
discharged, ORR has policies in place to promote children's well-being
as they transition into a new community, providing children with
multiple ways to connect following their sponsor placement, such as
through safety and well-being calls, post-release services, legal
services, or the 24/7 ORR National Call Center (ORRNCC), which connects
children and sponsors with community resources and is required to
report all safety concerns to ORR and other Federal, State, and/or
local entities.
While safety and well-being call data for FY 2023 and since shows
that ORR has been able to make contact with a child, the sponsor, or
both in 83 percent of these follow-up calls--which rely upon voluntary
participation of children or their sponsors. Safety and well-being
calls are just one of the variety of ways for children to be connected
to additional community supports. ORR has expanded PRS to a historic
level, and ORR is committed to expanding access to PRS even further to
all children by the end of FY 2024, as appropriations allow. Notably,
ORR does not have the authority to remove a child from a home--that
authority resides with law enforcement and State child welfare
agencies. ORR recognizes the critical importance of its coordination
and engagement with these agencies.
Specifics for a safety and well-being follow-up call are provided
in section 2.8.4. of ORR's UC Program Policy Guide. Care providers must
conduct these calls with an unaccompanied child and their sponsor 30
days after the release date. The purpose of the follow-up call is to
determine whether the child is still residing with the sponsor, is
enrolled in or attending school, is aware of upcoming court dates, and
is safe. The care provider must document the outcome of the follow-up
call in the child's case file, including if the care provider is unable
to contact the sponsor or child after reasonable efforts have been
exhausted. If the follow-up call indicates that the sponsor and/or
child would benefit from additional support or services, the care
provider must refer the sponsor or child to the ORRNCC and provide the
sponsor or child the ORRNCC contact information. If the care provider
believes that the child is unsafe, the care provider must comply with
mandatory reporting laws, State licensing requirements, and Federal
laws and regulations for reporting to local child protective agencies
and/or law enforcement. Additional information regarding required
reporting of events related to an unaccompanied child's safety and
well-being is available in section 5.8 of the UC Program Policy Guide.
Question. That same report from the The New York Times noted a
surge in monthly calls to HHS reporting trafficking, neglect, or abuse
of minors placed with sponsors.\20\
---------------------------------------------------------------------------
\20\ Ibid.
How many children have called the hotline to report abuse, neglect,
---------------------------------------------------------------------------
or trafficking, broken down by year?
What percentage of the calls to your hotline do you follow up with,
and who conducts this follow up?
In what manner is the follow-up conducted (e.g., by phone, in
person, etc.)?
Have any children been removed from sponsors' homes as a result of
calls to your hotline?
When is information received during hotline calls provided to local
law enforcement? Please provide your policies and procedures for such
referrals.
Answer. Upon their release, ORR provides unaccompanied children
with information on the ORRNCC, a 24-hour, 7-day-a-week resource not
only for released children, but their family members, sponsors, legal
service providers, child advocates, and other members of the community
who can request assistance or report concerns to the ORRNCC on a
child's behalf. The ORRNCC reports matters of safety concern to ORR and
refers and reports to the appropriate local law enforcement or other
authority, such as child protective services. Further, under ORR's UC
Program Policy Guide, any grant recipient or contractor who works with
or encounters unaccompanied children after their release from ORR care
is required to report any concern about the child's safety and well-
being to ORR and to the appropriate investigative agencies. Suspected
trafficking concerns are reported to ACF OTIP, which provides further
assessment assistance to ensure that victims can access appropriate
care and services.
In February 2023, ORR finalized a data-sharing MOA with OTIP and
NCMEC that will facilitate information sharing to protect unaccompanied
children who are victims of exploitation or trafficking or at risk of
being such victims. ORR also 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 will also connect children directly with
the appropriate authority when possible, and place a follow-up call to
the child to confirm if any further actions are needed.
If at any point during an interaction with an unaccompanied child,
either while in ORR's care or post-release such as through a call to
the ORRNCC, ORR care provider staff identifies or suspects any safety
concerns, they are required to issue a Notification of Concern to ORR
and notify appropriate investigative agencies, including local law
enforcement and child protective services. This includes any suspicion
that the child has run away, is at risk of or posing a danger to
themselves or others, or is at risk of human trafficking, exploitation,
or other abuse. ORR then conducts further review and determines what
actions should be taken, which may include additional reporting and
engagement with local law enforcement, State child welfare authorities,
and/or referral to PRS.
While ORR does not have authority to remove a child from a home--
that authority resides with State child welfare and law enforcement
agencies--ORR recognizes the critical importance of its notification
and coordination processes to ensure that local authorities can respond
appropriately to any allegations of abuse or neglect. For this reason,
ORR has engaged multiple child welfare agencies on the needs of
unaccompanied children. However, State child welfare agencies vary in
capabilities and these local and State entities also need robust
resources to help ensure their ability to review or investigate such
allegations.
With regard to the increase in the number of safety and abuse
reports received by the ORRNCC in recent years, notably, there has been
an unprecedented increase in the number of children referred to ORR's
care and custody since FY 2021. Further, HHS has worked to build
awareness and education around safety concerns, and improved outreach,
training, and efforts to reduce stigma for victims of trafficking have
resulted in an increase in individuals coming forward. Therefore, an
increase in reports also reflects the fact that ORR's improved
reporting policies are working.
Question. Please provide a step-by-step explanation of the process
law enforcement must go through to obtain records from the Office of
Refugee Resettlement (ORR) on the following: an unaccompanied alien
child, the sponsor of an unaccompanied alien child, and adult household
member(s) of an unaccompanied alien child.
How are law enforcement requests processed by ORR?
On average, how long does it take to provide a response?
On average, how long does it take to provide to an exigent request?
Under what circumstances does ORR require law enforcement to send a
subpoena or court order to obtain records relating to an unaccompanied
alien child, sponsor, and/or adult household member from an ORR
database?
Please cite the specific statute and/or regulation that requires
law enforcement to serve a subpoena or court order on ORR to receive
this information.
Describe all steps taken to ensure ORR is providing law enforcement
a complete return on its request.
Please provide an annual breakdown of the number of responses ORR
has provided to law enforcement and include the following information
for 2018, 2019, 2020, 2021, 2022, and 2023:
Number of times ORR was served with a subpoena or court order.
Number of times ORR responded to a law enforcement request without
requiring a subpoena or court order.
Number of times ORR failed to respond to a law enforcement request.
Number of times ORR responded to a law enforcement request with a
redacted production of records.
Number of times ORR responded to a law enforcement request with a
complete return on the requested information.
Number of times ORR responded to a law enforcement request with a
partial return on the requested information.
What law and/or regulation authorizes ORR to redact information
provided in response to law enforcement requests?
Answer. If ORR care provider staff, such as a case manager or
clinician, identifies or suspects any safety concerns at any point
during their interaction with an unaccompanied child either while a
child is in ORR care or post-release through a safety and well-being
call, they are required to issue a Notification of Concern to ORR and
notify appropriate investigative agencies, including local law
enforcement and child protective services. This includes any suspicion
that the child has run away, is at risk of or posing a danger to
themselves or others, or is at risk of human trafficking, exploitation,
or other abuse. ORR then conducts further review and determines what
actions should be taken, which may include additional reporting and
engagement with local law enforcement, State child welfare authorities,
and/or referral to PRS. It is important to note that ORR, as a Federal
agency, cannot remove a child from a home; that authority resides with
State child welfare and law enforcement agencies. ORR recognizes the
critical importance of its notification and coordination processes to
ensure that local authorities can respond appropriately to any
allegations of abuse or neglect.
If ORR care provider staff suspect that a child is a victim of
trafficking or is at risk of trafficking at any point during their
interaction with an unaccompanied child, per ORR policy, they must make
a referral to the Department's ACF Office on Trafficking in Persons
(OTIP) and to DHS's Homeland Security Investigations (HSI) Division and
DHS's Center for Countering Human Trafficking for further
investigation. OTIP provides further assessment assistance to ensure
that victims can access appropriate care and services. Such care is
then coordinated with ORR to provide direct referrals for grant-funded
comprehensive case management services, medical services, food
assistance, cash assistance, and health insurance tailored to the
child's individual needs.
The ongoing partnership with DOL and third-party entities such as
NCMEC, as well as our collaboration with other Federal, State, and
local government entities and national and community partners, are
crucial to our continuous commitment to protect and respond to the
needs of unaccompanied children who may be at risk of or victims of
exploitation, including child labor exploitation. These children face
unique challenges that require a whole of government response--and ACF
takes its part in this work seriously.
For incoming requests, ORR shares information with investigative
agencies in accordance with its policy in section 5.10 \21\ of the UC
Program Policy Guide and in accordance with each respective agencies'
mandate and authority, while not releasing information that is outside
the scope of their investigation. Investigative agencies may also use
the case file records request process outlined in section 5.10.1 \22\
of the UC Program Policy Guide. Requests for case file records are
eligible for expedited processing within seven (7) calendar days and
may be further expedited at ORR's discretion due to the time-sensitive
nature of the request. According to UC Program Policy Guide Section
5.10.1,\23\ if the requesting party does not provide the signature of
the sponsor, potential sponsor, or sponsor household member, ORR
redacts all information pertaining to those individuals where
information may be reflected in other types of unaccompanied children
case file records.
---------------------------------------------------------------------------
\21\ https://www.acf.hhs.gov/orr/resource/children-entering-the-
united-states-unaccompanied-section-5#5.10
\22\ https://www.acf.hhs.gov/orr/resource/children-entering-the-
united-states-unaccompanied-section-5#5.10.1
\23\ https://www.acf.hhs.gov/orr/policy-guidance/unaccompanied-
children-program-policy-guide-section-5#5.10.1
ORR UC Program Policy Guide section 10.1 \24\ outlines which case
file information is restricted from release. ORR does not release
certain information to the public or through case file requests that
could present a potential safety risk or violate the privacy of
children currently or formerly in care. In such cases (i.e., release to
the public or through case file requests), ORR does not release
information in children's case files pertaining to sponsors, potential
sponsors, or sponsor household members without their written consent.
ORR may also redact law enforcement-sensitive information, as well as
information protected by privacy considerations. ORR will not release
the following categories of information through the case file request
process unless this information is required to be provided in response
to a lawfully issued court subpoena, court order, or other court
litigation; or pursuant to federal investigation:
---------------------------------------------------------------------------
\24\ https://www.acf.hhs.gov/orr/policy-guidance/unaccompanied-
children-program-policy-guide-section-5#5.10
Internal communications, such as memoranda and emails by care
provider staff or ORR, to the extent they are included in the case file
(not all such emails and memoranda are considered case file
---------------------------------------------------------------------------
information);
Internal care provider incident reports;
Sponsor Assessments;
Family Reunification Packets;
Background check results;
Foster parent information; and/or
Information pertaining to other unaccompanied children who are not
the subject of the information requests, unless they are siblings of
the child whose information is being requested.
Question. Please provide a complete list of grantees or contractors
who have provided services related to Unaccompanied Alien Children
since 2021. Please provide to Congress an un-redacted and complete copy
of each contract or grant.
Answer. Provided below are lists of ORR grantees and contract
vendors from January 1, 2021, through March 14, 2023. Additional
information regarding grants and contracts are available on SAM.gov and
grants.gov.
Grantees
A Greater Love Foster Family
Agency, Inc. A New Leaf, Inc.
A Tender Love and Care, Inc Abbott House
Adore Children and Family Services,
Inc. Alba Care Services, Inc.
Applied Intellect LLC Ark Homes Foster Family Agency
BCFS Health And Human Services Berkshire Farm Center and Services
for Youth
Bethany Christian Services of
Michigan Bethany Christian Services USA LLC
Bethany Home Board of Child Care of the United
Methodist Church
Bokencamp Building Bridges Foster Family
Agency
Catholic Charities of The
Archdiocese of Miami Inc. Catholic Charities of The
Archdiocese of San Francisco
Catholic Charities of The Diocese
of Galveston-Houston Catholic Guardian Services
Cayuga Home for Children DBA Cayuga
Centers Center for Family Services, Inc.
Center for Juvenile Management Inc. Chicanos Por La Causa, Inc.
Child Crisis Arizona Children's Community Programs of
Connecticut, Inc.
Children's First Residential Care Children's Home of Kingston
Children's Home of Poughkeepsie Children's Village
Church World Service, Inc. Compass Connections
Comprehensive Health Services, LLC Cplc Texas, Inc.
Crittenton David and Margaret Youth and Family
Services
Devereux Foundation Dynamic Service Solutions LLC
Endeavors Eagle Lake Children's
Center Ettie Lee Homes Inc.
Family Endeavors, Inc. Florence Crittenton Services of
Orange County
Friends of Youth Grace House Children's Shelter
Gulf Coast Jewish Family and
Community Services Gwen Mikeal Village
Hands of Healing Residential
Treatment Center, Inc. Hanna's House
Heartland Human Care Services, Inc. Heartshare St. Vincent's Services
Hillsides His House Inc.
HOH Casa Harlingen HOH Case Sunshine
Holy Family Institute House of Hope
Incarnation Inspire Georgia
Inspiritus, Inc. International Rescue Committee Inc.
JCCA Jewish Child Care Association, New
York
Juan Pirtle Center Kids In Crisis, Inc.
Kidspeace National Centers, Inc. La Salle School
Latin American Youth Center Latino Family Institute
Leary Educational Foundation Inc. Liberty Wilderness Crossroads Camp,
Inc.
Lincoln Hall LSSS Upbring
Lutheran Family Services Rocky
Mountains Denver Lutheran Family Services Rocky
Mountains Fort Collins
Lutheran Immigration and Refugee
Service Lutheran Services Florida, Inc.
Lutheran Social Services of
Metropolitan New York, Lutheran Social Services of
Michigan
Lutheran Social Services of The
South, Inc. Marsell Consulting and MHS
Maryville Academy Mckinley Children's Center, Inc.
Mercy First Michigan Department of Labor and
Economic Opportunity
Morrison Child and Family Services Nafi Connecticut, Inc.
National Youth Advocate Program,
Inc. Neighborhood Ministries, Inc.
New Life Foster Family Agency Noank Community Support Services,
Inc.
Nueva Esperanza--Neighborhood
Ministries Nuevo Amanecer Latino Children S
Services
NYAP, Phoenix, AZ Pioneer Human Services
Rancho San Antonio Boys Home, Inc. Responsive Deployment LLC
Rising Ground, Inc. Rite of Passage, Inc.
Ruby's Place Samaritas
Seton Home Sheltering Arms Children and Family
Services, Inc.
Shenandoah Valley Juvenile
Detention Home Shiloh Treatment Center, Inc.
Southwest Key Programs, Inc. St Christopher's, Inc.
St. Peter St. Joseph Children`s
Home St. Vincent School for Boys
Sunny Glen Children's Home The Baptiste Group, LLC
The Villages, Inc. There Is Hope Foster Family Agency
Inc.
Timber Ridge School Trinity Youth Services
Twin Oaks Juvenile Development,
Inc. U.S. Committee for Refugees and
Immigrants
U.S. Conference of Catholic Bishops Urban Strategies LLC
U.S. Committee for Refugees and
Immigrants Inc. Village Family Services, The
Vision Quest National, Ltd. Vista Del Mar
Vista Haven Program Wayfinder Family Services
Welcoming Arms Youth Care
Youth For Tomorrow
Contract Vendors
255 North San Houston Hotel LLC Ace Parking Management, Inc.
Acacia Center for Justice Acuity
Aecom Technical Services, Inc. Allstate Security Services Inc.
Amentum Services, Inc. American Canyon Solutions, Inc.
American Hebrew Academy Inc. American Medical Response, Inc.
American National Red Cross Applied Intellect
Asset Protection and Security
Services Lp Azzmeiah V Ward
BCFS Health and Human Services Bexar, County of
Bravium Consulting Bre SSP Property Owner LLC
Caduceus Healthcare Inc. Carahsoft Technology Corp.
Cellco Partnership Dba Verizon
Wireless Cellco Partnership Dba Verizon
Wireless
Centerplate, Inc. Centro De Salud De La Comunidad De
San Ysidro Inc.
Chenega Naswik International LLC Cherokee Nation Management and
Consulting, LLC
Chickasaw Health Consulting, LLC Childrens Hospital--San Diego
Childrens Village Inc., The City of Dallas
Cni Thl Ops LLC Coforma LLC
Colliers International Valuation
and Advisory Services Community Action
Comprehensive Health Services LLC Conclusive Solutions LLC
Corporate Lodging Consultants, Inc. Cotton Commercial USA Inc.
Countertrade Products Inc. Cross Match Technologies, Inc.
Culmen International LLC Dallas Independent School District
Decorum Lackland LLC Deloitte Consulting LLP
Deployed Resources LLC Deployed Services LLC
Divine Family Care Pllc DLT Solutions, LLC
DRC Emergency Services LLC Duke University
Dulles systems Inc. Dynamic Construction Group LLC
Dynamic Service Solutions LLC Elite Medical Transport of Texas
LLC
Emergent, LLC Enterprise Technology Solutions,
Inc.
Erie Hotel Ventures LLC F2 Solutions, LLC
Family Endeavors Inc. Fieldprint, Inc.
Freeman Decorating Company General Dynamics Information
Technology Inc.
Global Evaluation and Applied
Research Solutions Global Spectrum, LP
Gogo Charters LLC Gray Matters Tech Services LLC
Guidehouse Inc. Guidehouse LLP
Hhc Trs Portsmouth LLC Houston Hold Em Inc.
ICF Ideal System Solutions, Inc.
Ingenesis Inc. Jackson Inn and Suites Inc.
J&J Maintenance Inc. Joltec LLC
Kearney and Company Pc Kind Inc.
Koniag Professional Services LLC Los Angeles County Fair Association
MVM, Inc. Mammoth Energy Services
Masterword Services Inc. Metcor Ltd.
NACC Disaster Services National Center for Appropriate
Technology
National Conference of State
Legislatures National Council for Behavioral
Health
Nugent Appraisal LLC PAE Applied Technologies LLC
Palantir Technologies Inc. Palm Laundry Inc.
Pennsylvania Academy Corp. Platinum Business Services, LLC
Precision Receivable Services, LLC Providencia Group LLC
Radiant Infotech LLC Rady Children's Hospital--San Diego
Rapid Deployment Inc. Resolve Soft
Rios Partners LLC San Diego Convention Center
Corporation, Inc.
SMG Holdings Inc. South Bay Community Services Inc.
Southwest Key Programs, Inc. SRE 4610 Opco Jv LLC
Starr Commonwealth Stratton Securities Incorporated
Supreme Bright Dallas Subtenant LLC TFC Consulting Inc.
The Mitre Corporation The Urban Institute
The Young Center for Immigrant
Children's Rights T-Mobile USA, Inc.
Tsm Corporation Unissant, Inc.
United Migrant Opportunity Services
Inc. United Site Services of California
Inc.
Universal Building Maintenance LLC Vera Institute of Justice Inc.
World Language Communications Inc. WSP USA Solutions Inc.
Xator LLC Young Center for Immigrant
Children's Rights
Your Recruiting Company Inc.
Question. Please list by name any former government employees who
have approached HHS or ORR within the last 5 years on the behalf of a
nongovernment organization seeking a grant or contract from HHS or ORR
related to Unaccompanied Alien Children.
Answer. The Federal Acquisition Regulation (FAR) gives government
agencies the authority to award contracts. HHS deploys oversight to
ensure accountability for contractual procedures. To help ensure
compliance with legal, regulatory, and contractual requirements, ACF's
contracting office, Government Contracting Services (GCS) currently
appoints a certified Contracting Officer's Representative to work with
the Contracting Officer to oversee required deliverables and
responsibilities for the contracts under its authority. All contracts
also include a Quality Assurance Surveillance Plan (QASP) requirement,
which details several contractor responsibilities, such as recurring
deliverables and data reporting requirements. The QASP ensures that
contracts adhere to the established terms and conditions and applicable
FAR clauses, including prohibitions and notification pertaining to
waste, fraud, and abuse of Federal funds.
Since June 2021, ACF and ORR have identified and continue to
implement a comprehensive range of actions to address the challenges
posed by the historic increase in the number of referrals to ORR in
2021, including those related to contracting--such as increasing
contracting staff capacity and moving toward competitive actions for
all new ICF capacity and other UC Program needs.
Question. Since its inception decades ago, the Organ Procurement
and Transplantation Network (OPTN) has exclusively contracted the
United Network for Organ Sharing (UNOS) to oversee the U.S.
transplantation network. The bipartisan Securing the U.S. Organ
Procurement and Transplantation Network Act, which was signed into law
on September 22, 2023, is intended to improve management of the U.S.
organ donation system by breaking up the contract for the OPTN and
encouraging participation from competent and transparent contractors.
HHS recently issued draft requests for proposals relating to the act's
implementation, a law intended to create competition.
Has HHS offered UNOS a contract extension for 6 months with an
option to extend for 2 years? Yes or No.
If so, do you agree this 2.5-year contract extension would go
against the very spirit of the law and allow UNOS to continue its
monopoly over OPTN? Please explain.
Answer. HHS intends to pursue a short contract extension to allow
time to award and onboard the new Board Support and Transitions
Operations awardees while the current contractor is still under
contract to sufficiently transfer knowledge and prevent disruption to
the 24/7, lifesaving work of the OPTN and to patients.
At every step of the modernization process, HHS has been committed
to robust competition for the first-ever multivendor solicitations for
OPTN contracts, and we were pleased that Congress supported our vision
for fundamental reform through passage of the bipartisan Securing the
U.S. Organ Procurement and Transplantation Network Act.
Question. On November 10, 2023, the United Network for Organ
Sharing (UNOS) alerted the Health Resources and Services Administration
(HRSA) of a data breach that exposed up to 1.2 million patient
records.\25\ Further, on March 18, 2024, HRSA announced it would post a
Request for Information (RFI) specifically focused on the Organ
Procurement and Transplantation Network (OPTN) NextGen IT contract
solicitation to modernize and develop organ matching technology. In
light of the RFI and the recent UNOS data breach, please answer the
following questions.
---------------------------------------------------------------------------
\25\ Bill Fitzgerald, Data breach at Richmond-based UNOS exposed
1.2 million patient records, CBS 6 News Richmond (December 19, 2023),
https://www.wtvr.com/news/local-news/unos-data-breach-dec-19-2023.
Will the OPTN NextGen IT contracts be open to both nonprofit and
---------------------------------------------------------------------------
for-profit entities?
Which entity, HHS or UNOS, is the owner of the patient data and
technology currently used to operate the OPTN?
If UNOS asserts ownership over OPTN patient data and the technology
infrastructure in place, how does HHS plan to move forward operating
the OPTN?
What steps has HHS taken to ensure data breaches do not occur with
UNOS or future contractors?
Does HHS require UNOS to employ data privacy and cybersecurity
protections for the information it is collecting? If so, provide those
requirements in full detail. If not, why not? Will HHS require these
protections for future contractors?
Answer. HHS is committed to pursuing the widest possible
competition in support of the OPTN Modernization. The OPTN NextGen IT
contracts will be open to both nonprofit and for-profit entities. These
OPTN NextGen IT awards and activities will be continuously informed by
the ongoing engagement with stakeholders and leading government
technologists, and the recently released RFI is one piece of that
approach.
HRSA will utilize all applicable Federal procurement law,
regulation, and policy to ensure accountability from new vendors, as we
do with other vendors that currently implement IT or other technical
functions through Federal contracts for other parts of the agency. HRSA
will embed accountability requirements and performance expectations in
the solicitation process for each OPTN vendor and actively monitor and
evaluate contractor performance.
The OPTN IT system is currently a contractor-owned, contractor-
operated system. HRSA ensures compliance with critical Federal IT
security standards, including National Institute of Standards and
Technology 800-171 and 800-53, the Federal Information Security
Modernization Act, and the Federal Risk and Authorization Management
Program. HRSA has unlimited rights and access to the OPTN data pursuant
to Federal Acquisition Regulation 52.227-14. Having access to this data
allowed HRSA to develop the OPTN dashboards that provides data at the
transplant hospital level. The upcoming contract solicitations will
provide further clarity on the data rights language per FAR
regulations. HHS is committed to ensuring lifesaving transplantation
continues without disruption as we advance our efforts to create a more
equitable, transparent, and accountable OPTN and higher-
performing transplant system.
Question. During the Senate Finance Committee's March 22, 2023,
hearing on HHS's Fiscal Year 2024 budget request, I shared that I had
received credible allegations regarding the United Network for Organ
Sharing (UNOS) threatening whistleblowers, including patients and
caregivers.\26\ I asked you whether HHS would commit to fully
investigating all instances of whistleblower retaliation and
harassment. You responded: ``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's going on.''
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\26\ U.S. Senate Committee on Finance, full committee hearing,
``The President's Fiscal Year 2024 Health and Human Services Budget''
(March 22, 2023), https://www.finance.senate.gov/hearings/the-
presidents-fiscal-year-2024-health-and-human-services-budget.
Please provide an update on what actions HHS has taken to make sure
---------------------------------------------------------------------------
allegations of wrongdoing by UNOS are investigated and addressed.
Has HHS referred any cases where UNOS allegedly retaliated against
or threatened whistleblowers, including patients and caregivers, to the
HHS OIG? If so, please explain.
Answer. HRSA's oversight of the OPTN board of directors and the
OPTN contractor has included taking action to address key areas of
concern, including member conduct and complaints. The February 2024
solicitation for the board of directors support contract includes
supporting the establishment of a code of conduct and process for
complaints, as well as supporting the new board of directors in
executing other oversight and management responsibilities. This will
include a process to escalate concerns to HRSA as needed. HRSA will
work with the HHS Office of the Inspector General and other agencies in
response to any allegations that warrant such action.
Question. On December 4, 2023, I wrote to you and the Centers for
Medicare and Medicaid Services (CMS) expressing concern about your
oversight of our Nations' nursing homes and the Care Compare Five-Star
Rating System. Specifically, CMS has failed to take action to address
findings and recommendations from U.S. Government Accountability Office
(GAO) and HHS Office of Inspector General (OIG) reports, dating back to
2011. Significant work remains to safeguard vulnerable Americans who
reside in these facilities and to ensure that Care Compare and the Five
Star Quality Ratings System provide accurate, timely, and meaningful
data about the quality of care in nursing homes. As of March 18, 2024,
HHS and CMS have not responded to my questions.
Please provide an update to GAO's 2014 recommendation for CMS to
include additional information on estimated out-of-pocket costs for
Medicare beneficiaries in what is now referred to as the CMS Compare
website.
Answer. With regard to estimating out-of-pocket costs for
beneficiaries, it is important to note that Care Compare is not
designed to serve as a compendium for the costs of a specific medical
service. Care Compare for nursing homes is focused on a facility's
overall performance, including the status of the facility's
participation in the Medicare and Medicaid programs and the facility's
quality and inspection results to enable a potential resident or their
family member to find an appropriate facility. CMS has added some
information to Care Compare relevant to cost. For example, Care Compare
indicates which doctors and clinicians accept the Medicare-approved
amount as payment in full, which results in lower out-of-pocket costs
for patients. Care Compare also indicates whether nursing homes
participate in Medicare or Medicaid. Medicare.gov also includes
consumer-friendly information regarding what Medicare covers.\27\
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\27\ https://www.medicare.gov/what-medicare-covers.
Question. In 2016, GAO found that the Care Compare website lacked
explanatory information about the Five-Star Rating System and
recommended that CMS add information to the Five-Star Rating System
that allows consumers to compare nursing homes nationally. HHS did not
concur with the recommendation and indicated that State variations on
the standard surveys make it difficult to compare nursing homes
nationally and that the Five-Star System is one of many factors
consumers can use when selecting a home. Please describe efforts that
have been made to reduce State variation in standard surveys. For
example, CMS regional offices tracking of State differences in
deficiency citations. In addition, do HHS and CMS plan to take any
additional actions to implement this recommendation? Please describe.
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If not, please describe why not.
Answer. With regard to comparing information about Medicare- and
Medicaid-
certified nursing homes nationally, two of the three components of the
Nursing Home Five-Star Quality Rating System on Care Compare are
already based on comparisons to national norms (quality and staffing
measures). The third element, the health inspection rating is, by
design, based upon the relative performance of facilities within each
State. However, there are State-by-State variations in the surveys
performed, making it difficult to compare nationally. For example,
Medicaid nursing home payment policy or complaint intake processes vary
by State, which can lead to differences in survey outcomes. CMS bases
Five-Star quality ratings in the health inspection domain on the
relative performance of facilities within a State to control for this
variation among States. When someone is looking for a nursing home,
they are typically looking for one in a particular State, not
nationwide, so the in-State comparison provides a more accurate
assessment of the local conditions for consumers. As State-level rating
systems provide a valid measure of a nursing home's performance
relative to other nursing homes in a particular location, CMS does not
plan any additional action on this recommendation.
The Nursing Home Five-Star Quality Rating System is just one of
many factors to be used when choosing a nursing home. Each individual's
preferences or needs may differ, so it's important for patients and
their families to consider a range of information to inform their
decision. For example, we recommend that individuals contact the
nursing home(s) they are considering and talk to the administrator,
director of nursing, or medical director. These individuals can speak
to the type of care they provide and answer questions that are
important to individual families. Individuals can also reach out to
their State long term care ombudsman's office; these individuals
specialize in long-term care options.
Question. In 2021, GAO found that while CMS had taken steps to
improve the staffing information on Care Compare, it still provided
limited information about staffing in nursing homes. GAO recommended
that CMS report minimum nurse staffing thresholds on Care Compare. Does
CMS continue to non-concur with this recommendation, or did its
position change? Please discuss and describe any steps that CMS has
taken or plans to take to address this recommendation.
Answer. With regard to staffing information on Care Compare, over
the last several years, CMS has made improvements to the information
reported. Specifically, in 2022, CMS began posting new weekend staffing
and staff turnover measures on Care Compare and added four new measures
to the Nursing Home Five-Star Quality Rating System.\28\ Care Compare
also includes the national and State average for each of the staffing
levels so consumers can compare a facility's performance to the
average.
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\28\ https://www.cms.gov/newsroom/fact-sheets/updates-care-compare-
website-july-2022.
On September 6, 2023, CMS published the ``Minimum Staffing
Standards for Long-Term Care Facilities and Medicaid Institutional
Payment Transparency Reporting'' proposed rule (88 FR 61352), which
proposed to establish comprehensive nurse staffing requirements to hold
nursing homes accountable for providing safe and high-quality care for
the over 1.2 million residents receiving care in Medicare and Medicaid-
certified LTC facilities each day.\29\
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\29\ https://www.govinfo.gov/content/pkg/FR-2023-09-06/pdf/2023-
18781.pdf.
While CMS holds individual nursing homes accountable for compliance
with the Federal requirements, CMS also holds State survey agencies
accountable for their performance in surveying and certifying nursing
homes. The State Performance Standards System (SPSS) is the process
used to oversee State survey agency performance for ensuring Medicare/
Medicaid-certified providers and suppliers are compliant with the
Federal requirements to improve and protect the health and safety of
Americans. The Fiscal Year 2024 SPSS Guidance includes measures in
three domains--survey and intake process, survey and intake quality,
and noncompliance resolution--to highlight these areas for State survey
agencies to promote consistent monitoring of compliance of health care
facilities.\30\ CMS publishes each State's performance on the
measures,\31\ and States that do not meet the requirements are subject
to corrective action. On September 1, 2023, the Biden-Harris
administration announced that CMS will undertake new analyses of State
inspection findings to ensure cited deficiencies receive the
appropriate consequence, particularly in incidences involving resident
harm. These analyses will ensure citations are applied more
consistently and reflect the seriousness of the deficiency, permitting
appropriate follow-through and enforcement.\32\
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\30\ https://www.cms.gov/files/document/admin-info-24-02-all.pdf.
\31\ https://www.cms.gov/files/document/admin-info-23-10-all.pdf.
\32\ https://www.whitehouse.gov/briefing-room/statements-releases/
2023/09/01/fact-sheet-biden-harris-administration-takes-steps-to-crack-
down-on-nursing-homes-that-endanger-resident-safety/.
Question. Please provide updates with respect to HHS's
implementation of the recommendations from the November 2022 HHS OIG
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report ``Long-Term Trends of Psychotropic Drug Use in Nursing Homes.''
Administrator Brooks La-Sure's March 15, 2023, letter to me states
that ``CMS is pursuing . . . ways to effectively monitor nursing home
compliance regarding the prescription of psychotropic medications,
including OIG's recommendations to use data to identify trends or
characteristics associated with a higher use of psychotropic drugs and
to continue evaluating whether additional action is needed.'' Please
describe and provide an update regarding these efforts and an update to
the implementation status of the HHS OIG recommendation.
Provide an update on the implementation status of CMS audits to
identify facilities with patterns of erroneous MDS coding of residents
with a diagnosis of schizophrenia. Please include a list of all
facilities that have been selected for an audit and all records related
to each audit.
For all audits, please provide details on whether the facilities'
Nursing Home Care Compare Five Star Quality Measure Ratings were
adjusted as a result of the findings.
Please describe and provide plans for CMS MDS audits in calendar
year 2024.
For each facility that admitted misconduct after receiving a
notification of an upcoming CMS audit, please provide the following:
(a) a full list of facilities that admitted misconduct, (b) a
description of the admitted misconduct, and (c) describe actions taken
by CMS as a result. If a ``lesser action related to their star
ratings'' was taken by CMS as a result of the disclosure, please
describe and provide details on how this action differed from the
originally planned action.
Please provide an update to CMS's plans to convene a Technical
Expert Panel (TEP) to examine current and future quality measurements
and the appropriateness of the exclusions for certain conditions,
including whether schizophrenia should no longer be excluded.
Specifically:
Has this TEP convened? If not, why not? If so, please provide an
update on findings and any proposed changes to quality measurements
that CMS is reviewing as a result along with timelines. Please include
any considerations related to schizophrenia as a quality measure.
Has CMS taken any other actions to consider certain condition
exclusions, such as schizophrenia, from calculations in future quality
measures? If so, please discuss and provide details on the specific
actions.
Answer. With regard to any inappropriate use of psychotropic drugs,
CMS has long been concerned that some nursing homes have erroneously
coded residents as having schizophrenia, which can mask facilities'
true rates of antipsychotic medication use. CMS has worked diligently
to optimize the quality of life for residents in nursing homes by
taking actions to reduce antipsychotic overuse in nursing facilities
and improve comprehensive care approaches to better address the
psychosocial and behavioral health needs of all residents. For example,
in 2016, CMS launched focused schizophrenia onsite surveys to
specifically address the issue of erroneous coding of schizophrenia in
nursing homes. CMS continues to look for opportunities to strengthen
the survey process and enforcement efforts to ensure that nursing homes
are focused on nonpharmacologic approaches and that residents are not
receiving medications that do not have a clinical basis. CMS is
currently evaluating the use of psychotropic drug use among residents
in nursing homes by analyzing schizophrenia diagnosis history and
prescribing trends, including inappropriate use of anticonvulsants. CMS
has announced the collection of anticonvulsant information, including
the indication, on the MDS effective October 2024.\33\
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\33\ Please see the Draft MDS 3.0 Item Sets version 1.19.1 at
https://www.cms.gov/medicare/quality/nursing-home-improvement/resident-
assessment-instrument-manual.
In addition, CMS has been conducting offsite audits of
schizophrenia MDS coding and, based upon the results, will adjust the
quality measure star ratings for facilities whose audit reveals
inaccurate coding. Specifically, any facility with this finding on
audit will have their quality measure star rating downgraded to one
star, which would drop their overall star rating by a star. Facilities
that have attested to errors have their quality measure rating
suppressed while they correct their data. Facilities with an audit
finding or an attestation to having coding errors are indicated on Care
Compare with a footnote next to their quality measure rating stating
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that the facility's data could not be verified through an audit.
For all facilities where patterns of coding inaccuracies were
identified, either through an audit or through a facility's admission,
CMS will monitor each audited facility's data to identify if the
information indicates they have addressed the identified issues, and if
any downgrades or suppressions that are applied should be lifted at the
time frames indicated above. Also, a follow-up audit may be conducted
to confirm the issue is corrected. CMS is committed to conducting
audits within the resources available.
CMS convened a Technical Expert Panel (TEP) to solicit feedback on
options for respecification of the ``Percent of Residents Who Newly
Received an Antipsychotic Medication (Short-Stay)'' and ``Percent of
Residents Who Received an Antipsychotic Medication (Long-Stay)''
measures to accurately capture antipsychotic medication use in nursing
homes. Feedback was solicited over the course of four topic-driven
sessions during the TEP meeting on February 24, 2023, and a poll
following the TEP. CMS is continuing to explore respecifying these
measures to include drug claims data.
Question. To provide greater transparency and efficiency in
tracking Federal grant spending, Congress passed the Grant Reporting
Efficiency and Agreements Transparency Act (``GREAT Act'') of 2019.\34\
The GREAT Act requires the Office of Management and Budget (OMB) and
the U.S. Department of Health and Human Services (HHS) to create ``data
standards to modernize grant reporting, reduce burden and compliance
costs of grant recipients, and strengthen the management and oversight
of Federal grants.''\35\ The Government Accountability Office published
a report titled ``Grants Management: Actions Needed to Ensure
Consistency and Usefulness of New Data Standards'' (January 2024), in
which it reported OMB and HHS have not met their implementation
requirements, beyond failing to meet the deadlines mandated by the
Act.\36\ Additionally, GAO found that OMB and HHS failed to adequately
involve stakeholders in the process of developing grant data elements
and communicate on the implementation of the GREAT Act, including with
Congress.\37\ Accordingly, GAO made four recommendations in this report
that remain open.\38\
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\34\ Grant Reporting Efficiency and Agreements Transparency Act,
Pub. L. No. 116-103, 133 Stat. 3266-3271.
\35\ U.S. Government Accountability Office, GAO-24-106164, ``Grants
Management: Actions Needed to Ensure Consistency and Usefulness of New
Data Standards'' (January 2024), at 9, https://www.gao.gov/assets/
d24106164.pdf; the GREAT Act requires OMB to designate the Federal
agency that ``administers the greatest number of programs under which
Federal awards are issued in a calendar year as the standard-setting
agency.'' 31 U.S.C. Sec. 6402(a)(1). OMB designated HHS as the
standard-setting agency in November 2020. GAO supra note 1, at 2.
\36\ Id.
\37\ U.S. Government Accountability Office, GAO-24-106164, ``Grants
Management: Actions Needed to Ensure Consistency and Usefulness of New
Data Standards'' (January 2024), at 23-24, 29-31, https://www.gao.gov/
assets/d24106164.pdf.
\38\ U.S. Government Accountability Office, ``Grants Management:
Action Needed to Ensure Consistency and Usefulness of New Data
Standards'' (last accessed March 13, 2024), https://www.gao.gov/
products/gao-24-106164. The four recommendations are as follows:
Recommendation 1: The Secretary of HHS, in consultation with the
Director of OMB, should ensure the grant data standards are consistent
with the definition of machine-readable by appropriately incorporating
technical specifications. Recommendation 2: The Secretary of HHS, in
consultation with the Director of OMB, should review and revise as
necessary the Version 2.0 grant data elements based on leading
practices for the formulation of data definitions. Recommendation 3:
The Secretary of HHS, in consultation with the Director of OMB, should
develop a stakeholder outreach plan to help ensure timely consultation
of all grant stakeholders identified in the GREAT Act during
development and implementation of the GREAT Act data standards.
Recommendation 4: The Director of OMB and Secretary of HHS should
jointly develop a process to ensure and document clear, regular, and
timely communication with congressional stakeholders regarding
implementation of the GREAT Act.
Please explain what steps HHS has taken--or plans to take--to close
the open recommendations the Government Accountability Office made in
its report titled ``Grants Management: Actions Needed to Ensure
---------------------------------------------------------------------------
Consistency and Usefulness of New Data Standards'' (January 2024).
Additionally, provide an updated compliance timeline for HHS's
implementation of the GREAT Act of 2019.
Answer. HHS concurred with all four recommendations in the GAO
report titled ``Grants Management: Actions Needed to Ensure Consistency
and Usefulness of New Data Standards'' (GAO-24-106164), and are working
with our joint implementation partners at OMB to make progress on
addressing and closing each. HHS and OMB are developing a roadmap for
overall GREAT Act implementation that will address the GREAT Act
requirements and the GAO recommendations, including establishing points
to appropriately consult stakeholders on the standards and keep
congressional stakeholders informed and engaged on our progress. HHS
and OMB are actively leveraging the Council on Federal Financial
Assistance, which has identified grants data standards as a key
priority, to collaboratively drive development of standard data
elements on a tranche-by-tranche basis.
______
Questions Submitted by Hon. Maria Cantwell
Question. One of the top concerns I hear from my constituents is
access to affordable prescription medications. A 2023 poll found that
one out of every three U.S. adults taking prescription drugs said they
could not take their medication as prescribed because of the cost.
Americans shouldn't be forced to choose between paying for rent,
groceries, or life-saving medications. These are not the kind of
health-care choices we want people to have to make.
We must address the impact that pharmacy benefit managers have on
drug prices. PBMs are industry middlemen with powerful influence over
the price and distribution of prescription medications. High drug costs
are making Americans suffer, and we need more transparency.
That is why I'm leading the PBM Transparency Act with Senator
Grassley. This bill would mandate transparency reporting requirements
for PBMs and direct the Federal Trade Commission to ban unfair and
deceptive practices like spread pricing and reimbursement clawbacks.
We must shine a light on the practices that PBMs engage in and
increase their accountability. My bill would also examine how PBMs use
anticompetitive practices to steer patients to their own mail-order and
affiliate pharmacies, which is contributing to a series of pharmacy
closures in my home State.
About 60 pharmacies closed in Washington State in 2023, including
20 Bartell Drugs locations. That's twice as many closures as reported
from the previous year. More closures mean patients must travel farther
to access necessary medications. For rural communities, this is
devastating and dangerous. In the town of Darrington in my home State,
the town's only pharmacy closed last July. To get to the nearest
pharmacy, Darrington residents now have to travel 56 miles. This is
unacceptable. Pharmacies are often the face of health care for
patients, and they should be open and accessible.
Do you agree that more transparency requirements, such as the ones
mandated in my bill, would hold PBMs accountable for their actions and
help reduce the cost of prescription medication?
What is the administration currently doing to prevent more pharmacy
closures? Will you work with me to prevent PBMs from steering patients
to their affiliate pharmacies and causing smaller and independent
pharmacies to shutter?
Answer. Section 1860D-11(i) of the Social Security Act generally
prohibits CMS from interfering in negotiations between drug
manufacturers, pharmacies, and prescription drug plan sponsors or from
instituting a price structure for the reimbursement of covered Part D
drugs. Consequently, CMS cannot prohibit PBMs from charging any
retroactive DIR fees.
Nonetheless, we continue to encourage Part D plan sponsors to work
with pharmacies to address cash flow concerns. On November 6, 2023, we
published a memo to all Part D plan sponsors via CMS' Health Plan
Management System (HPMS) titled ``Application of Pharmacy Price
Concessions to the Negotiated Price at the Point of Sale Beginning
January 1, 2024,'' which reiterates and emphasizes several key points
related to this issue that CMS also stated in the Medicare Program;
Contract Year 2023 Policy and Technical Changes to the Medicare
Advantage and Medicare Prescription Drug Benefit Programs final rule.
Within the memo, we strongly encouraged Part D plan sponsors to
consider options such as payment plans or alternate payment
arrangements in advance of the January 1, 2024, effective date. CMS
additionally emphasized that Part D plan sponsors must meet the prompt
payment requirements at 42 CFR Sec. 423.520 and pharmacy access
standards at Sec. 423.120.
More recently, we reiterated these points in our December 14, 2023
``CMS Letter to Plan Sponsors and Pharmacy Benefit Managers,'' where we
identified several concerns about practices by some plans and PBMs that
threaten the sustainability of pharmacies and impede access to care. We
encouraged plans and PBMs to work with pharmacies to alleviate these
issues and safeguard access to care. To view this letter, please visit
here: https://www.cms.gov/newsroom/fact-sheets/cms-letter-plans-and-
pharmacy-benefit-managers.
CMS uses existing monitoring and enforcement operations to ensure
that Part D plan sponsors comply with the access requirements
prescribed in Sec. 423.120 and prompt payment requirements in
Sec. 423.520. CMS conducts quarterly analyses of all Part D plan
sponsors' networks for the contract year to identify Part D plan
sponsors that are not meeting the pharmacy access standards as required
by Sec. 423.120(a)(1). Part D plan sponsors that do not meet the
standards will receive compliance actions, where the level of the
compliance action escalates when there is repeated noncompliance in
consecutive quarters. CMS monitors the status of Part D sponsors'
complaints from beneficiaries and providers, such as pharmacies. Prompt
payment or pharmacy access violations that come to CMS' attention can
result in a compliance action.
We are committed to ensuring beneficiaries have access to necessary
health services. We value the critical role pharmacies play in health-
care delivery and recognize that we must address the needs of
pharmacies to serve our beneficiaries effectively. We will continue to
engage with stakeholders and consider policies for inclusion in future
rulemaking that would lower prescription drug costs for beneficiaries,
address challenges that pharmacies face, and improve the quality of
pharmacy care.
Question. Since the Supreme Court overturned Roe v. Wade, 21 States
have banned or severely restricted abortion. Although Washington State
is a leader in protecting abortion rights at the State level, our
providers are overwhelmed by a surge in patients fleeing antichoice
States to seek care in Washington. The number of abortions provided in
Washington to out-of-State patients increased by 46 percent in 2022.
You have taken several actions to help protect access to abortion
and other reproductive services--including fighting to ensure that
people can access abortion in emergency situations, strengthening
medical privacy through HIPAA, and expanding access to the abortion
pill mifepristone by allowing pharmacies to dispense it. I was also
pleased to see that your budget calls for using title X to deliver $390
million in funding to help 3.6 million patients access family planning
services like contraception.
But we must do more. I've long said that the Washington-Idaho
border is the epicenter of this crisis. In the wake of ongoing legal
threats and harassment by anti-choice activists, our providers and
patients are scared and they need as much support as we can give them.
Can you talk about what you've done so far to bolster HIPAA
protections to protect providers and patients from harassment and
prosecution?
Answer. The Department has taken numerous actions since the Dobbs
\39\ decision, including issuing several guidance documents in June
2022 for Health Insurance Portability and Accountability Act of 1996
(HIPAA) covered entities (most health-care providers, health plans, and
health-care clearinghouses), their business associates, and the public.
These materials describe existing Federal protections for individuals'
health information related to reproductive health care, including
abortion, and make clear that the HIPAA Privacy Rule \40\ does not
require providers to disclose protected health information to third
parties. The materials also address the extent to which private medical
information is protected on personal cell phones and tablets.
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\39\ 597 U.S. 215 (2022).
\40\ 45 CFR part 160 and part 164, subparts A and E.
Within days of the Dobbs decision, the Department released Guidance
on the HIPAA Privacy Rule and Disclosures of Information Relating to
Reproductive Health Care,\41\ based on questions and concerns we heard
from patient advocacy groups and health-care providers. We additionally
issued a resource for consumers, Protecting the Privacy and Security
for Your Health Information When Using Your Personal Cell Phone or
Tablet\42\ to help provide best practices for consumers and patients in
safeguarding their own data given HIPAA's limitations. Further, in
response to Executive Order 14079, we held listening sessions and
discussed privacy in health care with communities and stakeholders
nationwide. In many of these conversations, we heard alarming accounts
of interactions with law enforcement and providers, consistent with
your reported investigation findings.
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\41\ https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/
phi-reproductive-health/index.html.
\42\ https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/
cell-phone-hipaa/index.html.
Subsequently, in April 2023, the Department published a Notice of
Proposed Rulemaking (NPRM) on the HIPAA Privacy Rule to Support
Reproductive Health Care Privacy.\43\ The proposal would prohibit the
use or disclosure of protected health information by covered entities
and business associates for an investigation or proceeding against any
person (including individuals, health-care providers, and others) for
the mere act of seeking, obtaining, providing, or facilitating legal
reproductive health care, including abortion care. The NPRM published
in the Federal Register on April 17, 2023, with a 60-day comment period
that closed on June 16, 2023 (88 FR 23506). HHS intends to finalize the
rule in the near future.
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\43\ 88 FR 23506 (April 17, 2023).
Question. Last month, CVS and Walgreens announced that they will
begin dispensing mifepristone through the new certification process
---------------------------------------------------------------------------
that FDA established under your leadership.
What are you doing to ensure that as many pharmacies as possible
apply for certification and start dispensing this essential medication?
Answer. Pharmacy certification is managed by the drug sponsors. We
recommend contacting Danco Laboratories, LLC, the applicant for
Mifeprex, or GenBioPro, Inc., the applicant for Mifepristone tablets,
200 mg for information.
Question. What would $390 million in family planning funding mean
for patients on the ground? How would this increased funding be used?
Answer. With increased funding, HHS will continue its commitment to
providing, through the title X family planning program, a broad range
of services related to achieving pregnancy, preventing pregnancy,
assisting clients with achieving their desired number and spacing of
children, as well as its focus on increasing access to and quality of
health-care services, especially in areas with low and limited access.
The additional funding will continue to support organizations to
provide even more family planning services to clients across the
country; provide training and technical assistance for title X
providers and staff; support data collection on title X services and
national trends related to reproductive health; and conduct research to
identify innovative approaches to expand access, improve quality, and
ensure equity to family planning services.
______
Questions Submitted by Hon. John Cornyn
Question. For years, Republicans and Democrats from the Texas
congressional delegation have raised concerns with ongoing efforts by
CMS to restrict the ways States can finance their share of the Medicaid
program. CMS continues to challenge the legality of financing methods
that are essential to Medicaid programs across the country and have
been previously approved by the agency.
Last year, CMS released an informational bulletin and proposed rule
that, if finalized, would threaten Texas's ability to care for millions
of its most vulnerable citizens. Furthermore, these efforts by CMS have
been found to run counter to statutory authority by a Federal judge in
Texas.
Does CMS intend to move forward with these proposed restrictions on
State financing through issuance of a final rule or by any other means?
How do you respond to criticisms that CMS's proposals are
incompatible with the agency's stated goal of preserving equitable
access to care for Medicaid managed care enrollees?
Answer. CMS has worked extensively with States across the country
on payment arrangements that help improve access and quality and reduce
health disparities. However, it's critical that we make sure these
arrangements comply with Federal law and ensure Federal dollars are
spent appropriately. That's why we've strengthened the accountability
and transparency of these payment arrangements and taken steps to hold
States accountable when necessary.
With respect to certain specific States, CMS is unable to comment
due to pending litigation.
Question. The market for electronic nicotine delivery systems,
commonly referred to as vapes or e-cigarettes, is in awful shape. It is
estimated that as much as half of that market today are illicit
products--primarily coming into the country from China. Some of this is
due to confusion regarding current regulations.
We need clarity and more enforcement activity. FDA has a list of
companies that have received marketing denial orders, but that list
doesn't indicate which products are covered by the denial orders. The
list also indicates at least 19 companies that have had the orders
stayed or rescinded due to a court challenge or administrative review--
and again most don't indicate the actual products covered.
FDA also has a list of actual products for which pre-market
approval applications have been filed, but doesn't indicate which ones
were and were not timely and does not say whether or not those products
can be sold--due to the administrative review status, court
proceedings, or otherwise.
It is clear from FDA's statements that some products that aren't on
the marketing granted list can still be sold based on court or
administrative proceedings, but the information about those products
just isn't available. How is any business, especially a small business,
supposed to follow all of this and guess which undisclosed products are
the subject of court stays or administrative reviews by FDA?
Don't you agree with me that what makes the most sense is for FDA
to provide everyone with clear lists of which actual products can and
cannot be sold so that everyone has clarity and the law can be better
enforced?
Answer. To date, FDA has authorized 27 tobacco-flavored e-cigarette
products and devices. FDA provides a publicly available list of e-
cigarette products and devices with marketing granted orders (MGOs) so
that retailers, consumers, and others may know which products may be
legally marketed. See https://www.fda.gov/tobacco-products/premarket-
tobacco-product-applications/premarket-tobacco-product-marketing-
granted-orders.
Question. For the past year a bipartisan group of Senators led by
Senators Cassidy and Warner have been engaged in an effort to improve
integrated care for the dual-eligible population. As you are aware,
dually eligible beneficiaries account for a disproportionate share of
spending in Medicare and Medicaid, and most are covered by two separate
Medicare and Medicaid plans that do not coordinate or align enrollment.
The proposal we are working on seeks to deliver coordinated care for
the duals population to provide higher quality and better outcomes.
Can you commit to helping in this effort by providing technical
assistance on this important proposal in a timely manner?
Answer. Dually eligible individuals face a complex assortment of
enrollment options. To improve the experiences and outcomes for dually
eligible individuals, CMS issued the Contract Year 2025 Medicare
Advantage and Part D proposed rule, which includes a proposal to
increase the percentage of dually eligible Medicare Advantage plan
enrollees who are in plans that also cover Medicaid by offering more
opportunities for enrollment in plans that integrate Medicare and
Medicaid and more opportunities to switch to traditional Medicare, as
opposed to MA plans offered by organizations that are not related to
the organization that offers the enrollee's Medicaid plan. The agency
is committed to promoting beneficiary choice and facilitating improved
access to an array of Medicare coverage options for low-income
beneficiaries. CMS would be happy to provide technical assistance on
any draft legislation.
Question. The recent cyber breach of Change Healthcare has shown us
how vulnerable our Nation really is to bad actors. While you have put
forth some short-term solutions to address fiscal concerns of providers
whose payment claims are tied up, as well as urging payers to own the
failures of the breach, what more can HHS do to ensure enhanced data
safety moving forward so we don't face another cyber breach of this
magnitude in our health system?
Answer. Sector (HPH) and ASPR is the designated lead within HHS for
Sector Risk Management Agency (SRMA) activities. In this role, ASPR
leads the incident response, coordinates across intra- and
interagencies, assesses and reports impacts, and engages and informs
the health-care sector. On February 27, 2024, HHS, along with the
Cybersecurity and Infrastructure Security Agency (CISA) and the Federal
Bureau of Investigation (FBI), released an updated joint cybersecurity
advisory (CSA) on ALPHV Blackcat ransomware, which includes recently
and historically observed tactics, techniques, and procedures (TTPs)
and indicators of compromise (IOCs) to help organizations protect
against ransomware. ASPR has led interagency coordination engagements,
including regular, sometimes daily, calls in support of incident
response. This allowed us to coordinate the response of the U.S.
Government (USG), including the FBI, CISA, Department of Veterans
Affairs (VA), DoD, and others.
In December 2023, HHS released a concept paper that outlined the
Department's holistic cybersecurity strategy for the HPH. Towards the
end of January, we released the voluntary HPH cybersecurity performance
goals (CPGs), aligned with the first pillar of this strategy. We also
rolled out a new gateway website as part of our efforts to establish
the one-stop shop for HHS cyber and simplify how the sector can access
our resources and tools across all HHS divisions. These HPH CPGs will
help health-care organizations implement high-impact cybersecurity
practices and ease access to the many cybersecurity resources HHS and
other Federal partners offer. In the coming weeks and months as we
emerge from this attack, we will be focused on developing additional
tools, resources, and guidance to help with implementing these HPH CPGs
and look forward to working with the sector to help improve its
cybersecurity posture. We also launched the 2.0 version of our RISC
Toolkit to the sector. It allows a system of systems risk assessment
instead of focusing on a specific hospital.
It is important to note that this cyber-attack was of a private
company, Change Healthcare, and not of HHS systems. We continue to
engage regularly with the health-care sector and are urging
UnitedHealth Group (UHG), clearinghouses, insurance companies, and
other payers to do everything they can to maintain patients' access to
care and support providers.
The HHS Healthcare Cybersecurity Coordination Center (HC3) was
created by the Department to aid in the protection of vital,
controlled, health-care related information, and to ensure that
cybersecurity information sharing is coordinated across the health care
and public health (HPH) sector. The HC3 developed and distributes
briefs on relevant cybersecurity topics, provides high-level sector
alerts to assist the sector with defense of large scale and high-level
vulnerabilities, and develops white papers and other products all aimed
to increase cybersecurity awareness and readiness in the HPH sector.
Question. The Centers for Medicare and Medicaid Services on March
9th issued a notice formally announcing terms for hospitals,
physicians, and other providers impacted by the Change Healthcare
cyberattack to apply for accelerated and advance payments (AAPs). We
have heard concerns from providers that recoupment begins immediately,
interest rates are high compared to where they were during the public
health emergency (4 percent then and currently 12.375 percent), and the
requirement for providers to have been unable to obtain sufficient
funding from other available sources because it is unclear what
criteria is being used to determine that.
Given these concerns, what steps are you taking to provide greater
flexibility for providers?
I also understand that providers who are participating in the
Medicare Periodic Interim Payment (PIP) program are not eligible for
the HHS accelerated and advanced payment program that is being made
available to health-care providers impacted by the cyberattack. As you
know, the PIP program provides cash flow assistance for critical health
providers, including long-term acute-care hospitals (LTACs) who require
additional cash flow predictability in order to serve medically complex
and often longer-stay patients.
As you know, Medicare PIP payments only help offset some of the
costs for Medicare Part A fee-for-service claims and represent only a
fraction of total Medicare payments received by a hospital. Medicare
outlier, Part B and Medicare Advantage payments are not accounted for
in the PIP program. For health-care providers in the Medicare PIP
program, they are experiencing many of the same Medicare payment
shortfalls and difficulties with billing as other health-care providers
as a result of the cyberattack. In addition, these providers are also
experiencing delays in checking patient eligibility and benefits,
notification of admissions, billing, and payment collections in
affiliated hospitals, physician offices, and with other providers.
Given that health-care providers in the PIP program are
experiencing the same challenges as other Medicare providers, does CMS
have any flexibility to allow these providers to apply and participate
in HHS advanced and accelerated payment programs?
Providers who participate in the Medicare Periodic Interim Payment
(PIP) program are required to submit 85 percent of their claims within
30 days after a patient is discharged, and 85 percent of those claims
must be error free or ``clean.'' Failure to meet these requirements
places a provider at risk of being removed from the PIP program.
Since the Change Healthcare cyberattack on February 21, 2024,
claims submission and processing stopped broadly for Medicare claims
and has since been delayed while providers are establishing
workarounds. This jeopardizes a provider's ability to meet timeliness
requirements.
Establishing alternatives to submit claims requires new
arrangements that take time to get up and running. And even once
implemented, new processes may be slowed by the administrative
procedures for eligibility and prior authorization (new arrangements
will lack specific payer edits on claims) that if lacking these
determinations, will cause claims to be denied and further delay paying
for care that has been provided.
Would CMS be willing to use its authority to temporarily waive the
timeliness requirements for filing Medicare claims by those providers
in the PIP program impacted by the cyberattack?
Answer. CMS recognizes the impact the Change Healthcare cyberattack
has had on providers, particularly many small providers and those in
rural areas. We are working expeditiously to do our part to ease the
impact of the cyberattack.
Specifically, CMS has taken several key actions to support the
provider community during this difficult situation. CMS announced the
availability of accelerated and advance payments for affected Medicare
providers of services and suppliers. Providers and suppliers should
reach out to their Medicare Administrative Contractors for more
information or visit CMS's website for Frequently Asked Questions and
Answers. CMS has also provided flexibility for certain Medicare
reporting deadlines. We encourage Medicare Advantage and Medicare Part
D plans to offer advance funding to providers, and to remove or relax
certain timely filing and prior authorization requirements. We have
provided flexibility for certain Medicare reporting deadlines.
Similarly, we strongly encourage Medicaid and CHIP managed care plans
to remove or relax prior authorization and utilization management
requirements, and to consider offering advance funding to providers, to
the extent permitted by the State.
CMS has maintained frequent communications with UnitedHealthcare
and will continue to press them to communicate with the health-care
sector and to offer assistance to providers and suppliers to ensure
continuity of operations for all health-care providers and suppliers
impacted by the incident.
Question. HHS has cleared a CMS rule that is waiting for White
House approval that would overhaul the Medicare Advantage enrollment
process. This committee has been engaged in this issue, and Chairman
Wyden has led inquiries into marketing practices that cause headaches
for seniors. But your proposal would limit fees in the enrollment
market for everyone--not just the bad actors.
Would you commit to me to ensure that CMS will not limit the
ability of agents and brokers to help beneficiaries find Medicare
Advantage plans that best fit their needs?
Answer. We agree that it is critical to ensure that as the MA and
Part D programs continue to grow, it remains viable and that seniors
and individuals with disabilities eligible for Medicare can make
informed decisions about their health-care coverage, and, when
appropriate, enroll in the plan that is best suited to their personal
health-care needs. As discussed in the CY 2025 MA and Part D proposed
rule, (88 FR 78476), section 1851(j) of the Social Security Act
requires that CMS develop guidelines to ensure that the use of
compensation creates incentives for agents and brokers to enroll
individuals in the MA plan that is intended to best meet their health-
care needs. We have learned, however, that many MA and stand-alone
Prescription Drug Plans (PDP), as well as third-party entities with
which they contract (such as field marketing organizations (FMO)), have
structured payments to agents and brokers that have the effect of
circumventing existing CMS regulations that limit agent and broker
compensation to specified fair market value (FMV) levels. CMS has also
received complaints from different organizations, including State
partners, beneficiary advocacy organizations, and MA plans to this
effect. A common thread to the complaints is that agents and brokers
are being paid, typically through various purported administrative and
other add-on payments, amounts that cumulatively exceed the maximum
compensation allowed under the current regulations. Moreover, CMS has
observed that such payments have created an environment, not dissimilar
to what originally prompted us to set limits on agent and broker
compensation in 2008, where the amounts being paid for activities that
do not fall under the umbrella of ``compensation,'' are rapidly
increasing.
We understand that FMOs help millions of Medicare beneficiaries to
learn about and enroll in Medicare, Medigap, MA plans, and PDP plans by
providing guidance on plan options, including comparisons of relative
costs and coverage, as well as assisting beneficiaries with applying
for financial assistance. However, financial incentives to agents and
brokers, more readily paid by large plans, can result in beneficiaries
being steered to some MA plans over others based on excessive broker
and agent compensation rather than on the enrollee's best interest.
Therefore, as part of the CY 2025 MA and Part D proposed rule, CMS
proposed to redefine ``compensation'' to set a clear, fixed amount that
agents and brokers can be paid regardless of the plan the beneficiary
enrolls in.
In our proposed rule, CMS is focused on current payment structures
among MA organizations, agents, brokers, and third-party marketing
organizations (TMPO), including FMOs, that may incentivize agents or
brokers to emphasize or prioritize one plan over another, irrespective
of the beneficiary's needs, leading to enrollment in a plan that does
not best fit the beneficiary's needs and a distortion of the
competitive process. In this rule, CMS has proposed to: (1) generally
prohibit contract terms between MA organizations and agents, brokers,
or other TMPOs that may interfere with the agent's or broker's ability
to objectively assess and recommend the plan which best fits a
beneficiary's health-care needs; (2) set a single agent and broker
compensation rate for all plans, while revising the scope of what is
considered ``compensation''; and (3) eliminate the regulatory framework
which currently allows for separate payment to agents and brokers for
administrative services.
CMS is committed to collaborating and engaging with stakeholders
and interested parties in the policymaking process. The comment period
for the CY 2025 MA and Part D proposed rule closed on January 5, 2024.
CMS sought comment on these proposals to further inform our
calculations and policy direction. We have received feedback from many
interested parties on our proposed policy, and we will carefully
consider these comments throughout this rulemaking process.
Question. On August 30, 2023, the Department of Health and Human
Services announced it recommended the reclassification of marijuana to
Schedule III to the Drug Enforcement Administration (DEA). Four months
later, HHS released an unredacted version of its recommendation to
reclassify the drug. FDA has used an established five-factor analysis
in determining whether Schedule I drugs have ``currently accepted
medical use.'' In the report supporting the recommendation to
reschedule marijuana, FDA used a new two-factor test to make that
determination.
Why did HHS create a new two-factor test to determine currently
accepted medical use when the five-factor test has been used for
decades by Republican and Democratic administrations?
Answer. The scheduling review documents reflect HHS's evaluation of
the scientific and medical evidence and its scheduling recommendation
to DOJ.
Question. In the recommendation, FDA measured marijuana's potential
for abuse by comparing it to a limited selection of Schedule I, II, and
III drugs. For example, FDA compared marijuana to heroin, another
Schedule I drug. The recommendation claims that because marijuana has a
lower abuse potential than heroin, it shouldn't be in the same
category. FDA failed to compare marijuana to other Schedule I drugs,
such as LSD.
Why did FDA fail to do a more rigorous analysis and compare
marijuana's abuse potential against all Schedule I drugs?
Answer. The scheduling review documents reflect HHS's evaluation of
the scientific and medical evidence and its scheduling recommendation
to DOJ.
Question. The Centers for Medicare and Medicaid Services have
proposed significant changes to the Medicaid Drug Rebate Program. The
savings from these changes have nothing to do with patient
affordability; they are simply increases in the rebates realized by the
Medicaid program at the Federal and State levels. Despite broad
concerns being voiced about the concept, implementation, and legality
of the proposals, the agency has indicated that it will move forward
this June.
Will you commit that policies will not be finalized until
stakeholders' concerns are addressed adequately? Specifically:
Manufacturers, distributors, and others in the supply chain have
indicated that the operationalization of the stacking provision is not
possible with current technology and within the current system and is
not permitted under the Medicaid statute.
The survey proposed is intended to collect proprietary information
from manufacturers with no clear government use articulated for the
information gathered, but the implication is that the information may
be shared publicly in some way.
The shift of inpatient drugs into the outpatient category is a
violation of the statute and congressional intent.
The definition of vaccine that CMS included in the proposed rule is
out of alignment with other agencies and could create barriers to
access by the Medicaid population. The MDRP definition of a vaccine
should be based on whether a product is either recommended by ACIP for
adults and is included in the VFC program.
Answer. CMS is currently in the rulemaking process and cannot
comment on or speculate about any potential changes to the proposed
policies or when a final rule may be issued. As always, we are closely
reviewing the comments received in response to the proposed rule. Input
from stakeholders is an important contribution to CMS's policymaking
process, and we are now considering the abundance of comments we
received during the public comment period.
______
Questions Submitted by Hon. John Thune
Question. I have been a long-time supporter of establishing
permanent access to telehealth services.
And now that we're on the other side of the public health
emergency, I hope that all of us can agree that the pandemic
demonstrated the value of telehealth and the benefit it can afford to
patients across the Nation, in particular those in rural areas that
would otherwise be forced to travel hundreds of miles for doctor's
appointments.
Congress extended many of the COVID-era flexibilities for Medicare
telehealth services through 2024, and earlier this year, I joined some
of my colleagues in sending a letter to you highlighting the critical
role of telehealth in the delivery of health care and the importance
for these telehealth services to be made permanent before they expire
at the end of this year.
Do you commit to working with Congress on this effort and
advocating for permanent telehealth policies that would ensure Medicare
beneficiaries maintain access to these vital services?
Furthermore, what measures is the department taking to minimize
fraud as we seek to ensure telehealth services remain available?
Answer. HHS and CMS continually consider how to best ensure access
to medically necessary items and services and makes changes where
appropriate and permissible under our statutory authority. We recognize
the vital role that telehealth can play in the delivery of care,
particularly among populations that are underserved. We implemented
section 4113 of the Consolidated Appropriations Act, 2023, which
extended many telehealth flexibilities adopted during the public health
emergency for COVID-19 through December 31, 2024. Additionally, through
notice-and-comment rulemaking, the CMS solicited public comment and
implemented regulatory changes that have permanently expanded certain
telehealth policies that are within the agency's authority to modify.
Some changes to Medicare telehealth policy would require legislative
action to amend the statute, and we look forward to our continued work
with Congress on this crucial issue.
CMS recognizes the importance of analyzing the impact of these
changes, and, as such, immediately evaluated the waivers and
flexibilities issued by the agency to determine the potential for
fraud, waste, and abuse in the Medicare program. This process included
identifying program integrity risks and vulnerabilities associated with
the waivers and flexibilities; prioritizing those with the largest
potential for financial loss, beneficiary harm and/or likelihood of
occurrence; and creating mitigations that addressed these program
integrity risks and vulnerabilities, including those related to
telehealth.
One such mitigation strategy was the continued use of data
analytics to identify potential program integrity risks. During and
after the PHE, CMS has continued to analyze claims data to monitor,
trend, and respond to existing telehealth fraud schemes and to detect
and respond to potential new emerging fraud schemes. CMS uses a robust
program integrity strategy to reduce and prevent Medicare improper
payments, which includes the use of the Fraud Prevention System (FPS).
The FPS is a predictive analytics technology that runs sophisticated
algorithms against Medicare Fee-for-Service (FFS) claims nationwide.
When FPS models identify aberrant activity or patterns, the system
automatically generates and prioritizes leads for further review and
investigation by Unified Program Integrity Contractors (UPICs). Based
on the results of all information collected, the UPICs coordinate with
CMS and the Medicare Administrative Contractors in taking appropriate
administrative action to recover improper payments and prevent future
loss of funds, or the UPICs refer the case to law enforcement.
Additionally, CMS has supported our Federal law enforcement
partners during and after the PHE on various fraud schemes including
those related to telehealth. CMS continues to meet regularly with law
enforcement to discuss new cases, fraud referrals, active UPIC and law
enforcement cases, and paths for various administrative actions.
CMS has also taken action to prevent improper Medicare payments by
educating health-care providers and suppliers on proper billing. For
example, CMS has undertaken a number of stakeholder calls including
open door forums and Medicare Learning Network calls, as well as
published numerous pieces of subregulatory guidance designed to educate
practitioners on the additional telehealth flexibilities, including how
to appropriately bill for these services.
Question. There are many features to this administration's
disastrous handling of the border and their own created crisis. One of
them is under your responsibilities to handle the care and placement of
unaccompanied minors encountered at the border.
By your department's own data, there have been approximately
400,000 unaccompanied minors released into the country just in the past
3 years.
Can you tell this committee the number of individuals who have
presented at the border over the past year who have posed as minors yet
are adults?
Can you tell this committee the number of minors who have presented
at the border over the past year with a known gang affiliation?
Answer. HHS defers to the Department of Homeland Security (DHS) on
encounters with adults posing as minors who are identified before DHS
makes a referral to HHS. HHS may make additional age determinations of
individuals transferred to HHS's Office of Refugee Resettlement (ORR),
if there is a reasonable suspicion that they are 18 years or older. The
Homeland Security Act of 2002 and the Trafficking Victims Protection
Reauthorization Act of 2008 (TVPRA) instructs HHS to devise age
determination procedures for individuals without lawful immigration
status in consultation with DHS. The TVPRA requires that age
determination procedures take into account multiple forms of evidence.
If an individual's age is questioned at the time of admission to an
HHS-funded care provider facility, the case manager must consult with
the Federal Field Specialist (FFS) to make the age determination. In
the event there is conflicting evidence, the FFS makes the age
determination based on their review of multiple forms of available
evidence, as set forth in section 1.6 of the UC Program Policy Guide.
DHS fingerprints all children 14 years old or older before making
any referral to ORR, and if there is criminal history based on those
biometrics, that history is reported to ORR, as required under the 2021
HHS and DHS Memorandum of Agreement (MOA). This MOA also creates an
affirmative obligation for DHS to provide to ORR, the age of the
unaccompanied child, along with any criminal history gang affiliation,
or court documents, and any other related information. Per ORR policy,
all children entering ORR custody undergo a variety of assessments,
including the Initial Intakes Assessment, the Unaccompanied Child (UC)
Assessment, Case Review, and clinical assessments, and children meet
weekly with a trained clinician and case manager who are regularly
assessing the children for issues that may impact their placement with
a vetted sponsor. These assessments probe for human trafficking
indicators and other vulnerabilities.
In accordance with section 3 of the ORR UC Program Policy Guide,
various assessments determine, among other things, if unaccompanied
children in ORR's custody and care may be a danger to themselves or
others. In the event an unaccompanied child is assessed by ORR to be a
danger to themselves or others, have a criminal history, or require
close supervision, ORR may place the child in a restrictive facility.
Restrictive facilities provide a heightened level of staff supervision,
increased communication among staff, and services to prevent a child
running away, among other measures and procedures to ensure safety and
security.
Question. Last month's cyberattack against UnitedHealth Group has
had wide-ranging repercussions on health systems in rural and urban
areas across the Nation.
As the fallout from the cyberattack continues, can you please speak
to what steps HHS is taking to support providers that were impacted by
the cyberattack?
And specifically, what steps is your staff taking or planning to
take to help health systems that are attempting to change
clearinghouses for which their claims are processed but are facing
frustrating delays in doing so? Is there any technical assistance that
HHS is providing to health systems?
Answer. CMS recognizes the impact the Change Healthcare cyberattack
has had on providers, particularly many small providers and those in
rural areas. We are working expeditiously to do our part to ease the
impact of the cyberattack.
Specifically, CMS has taken several key actions to support the
provider community during this difficult situation. CMS announced the
availability of accelerated and advance payments for affected Medicare
providers of services and suppliers. Providers and suppliers should
reach out to their Medicare Administrative Contractors for more
information or visit CMS's website for Frequently Asked Questions and
Answers. CMS has also provided flexibility for certain Medicare
reporting deadlines. We encourage Medicare Advantage and Medicare Part
D plans to offer advance funding to providers, and to remove or relax
certain timely filing and prior authorization requirements. We have
provided flexibility for certain Medicare reporting deadlines.
Similarly, we strongly encourage Medicaid and CHIP managed care plans
to remove or relax prior authorization and utilization management
requirements, and to consider offering advance funding to providers, to
the extent permitted by the State. Furthermore, in March, CMS provided
States with guidance to help coordinate efforts to avoid disruptions to
care.
CMS has maintained frequent communications with UnitedHealthcare
and will continue to press them to communicate with the health-care
sector and to offer assistance to providers and suppliers to ensure
continuity of operations for all health-care providers and suppliers
impacted by the incident.
Question. Nursing homes across the Nation are facing a number of
challenges that have forced many long-term care facilities to close or
reduce the number of patients they can care for.
This is acutely problematic for rural States like South Dakota
where the next available nursing home bed could be hundreds of miles
away from home and away from friends and family.
The minimum staffing standards for long-term care facilities
proposed rule from CMS that would slap onerous and unworkable staffing
mandates on our Nation's nursing homes would exacerbate this problem
and undoubtedly force more facilities to close their doors.
I am fearful that many nursing homes, including those in rural
States like my State of South Dakota, would be forced to close as a
result of this one-size-fits-all Federal staffing mandate.
Do you recognize the bipartisan concerns with this proposed rule
and the reality that nursing homes would not be able to comply with an
inflexible staffing mandate given the shortage of individuals in the
nursing field today?
Answer. Staffing in LTC facilities is a persistent concern,
especially among low-performing facilities that are at most risk for
providing unsafe care. Numerous studies have shown that staffing levels
are closely correlated with the quality of care that LTC facility
residents receive.\44\ CMS believes that national minimum nurse
staffing standards in LTC facilities are necessary at this time to
protect resident health and safety and ensure residents' needs are met.
We intend to promote safe, high-quality care for all residents
regardless of geographic location. At the same time, CMS acknowledges
the unique challenges that rural LTC facilities face, especially
related to staffing, and recognizes the need to strike an appropriate
balance that considers the current challenges some LTC facilities are
experiencing.
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\44\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive Report. Report prepared for the Centers for Medicare and
Medicaid Services.
In developing the proposed staffing requirements for LTC
facilities, CMS sought to identify minimum standards that, when applied
across all LTC facilities, would significantly lower the risk of unsafe
and low-quality care for residents, while being implementable. We
believe we are proposing achievable goals that are informed by the
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totality of the evidence.
While we fully expect that LTC facilities will be able to meet our
proposed minimum staffing standards, we recognize that in some
instances, external circumstances may temporarily prevent a facility
from achieving compliance despite the facility's demonstrated best
efforts. Therefore, we proposed to allow for a hardship exemption. If
finalized, LTC facilities could qualify for a hardship exemption from
the minimum nurse staffing standards if they met several criteria,
which are discussed in the proposed rule. The facility would have to be
located either in an area where the supply of health-care personnel was
insufficient, or at least 20 miles away from another LTC facility.
Facilities also would have to meet other criteria including
demonstrating good faith efforts to hire and retain staff and not be
subject to disqualification.
Given the challenges rural communities face, CMS is proposing later
implementation dates for rural facilities. Rural facilities will have 3
years to meet the proposed 24/7 Registered Nurse (R.N.) requirement and
5 years to meet the proposed minimum staffing standards. In addition,
CMS is maintaining the current statutory waiver process for facilities
for R.N. onsite requirements under qualifying circumstances. Facilities
seeking relief from the proposed 24/7 R.N. requirement in the proposed
rule would follow the applicable existing waiver process, as required
by statute, and set out in the current regulations. As the LTC sector
continues to recover from the COVID-19 pandemic, the proposed standards
take into consideration local realities in rural and underserved
communities.
Question. Improving the transparency, management, and hiring
practices of the Indian Health Service has been a priority of mine for
many years, and it's a big focus of the legislation I introduced with
Senator Barrasso, the Restoring Accountability in the IHS Act.
Can you please update this committee on the actions HHS has taken
or plans to take to improve IHS and bring more accountability to the
agency, because clearly more needs to be done?
Answer. IHS leadership is committed to providing improved
transparency on initiatives that are being undertaken by the IHS, as
well as in coordination with our partnering agencies, by enhancing
dialogue with tribal and urban Indian organization partners to ensure
our actions are sustainable and impactful. To keep everyone informed on
IHS Work Plan priorities, IHS provides quarterly updates on our
progress through the IHS Work Plan Status Report, which is posted to
the IHS website.
The 2024 Agency Work Plan outlines steps the IHS is taking to
address priorities as well as mitigate risks. The plan details critical
actions that will ensure safe, quality, and patient-centered care, as
well as improve IHS operations and communication. This plan builds
internal capacity to design, implement, and evaluate actions and
processes by applying principles of a learning organization that will
lead to sustainable improvements in the management and oversight of our
programs and services. The IHS will achieve these goals through
rigorous management and oversight of resources to ensure the health-
care needs of American Indians and Alaska Natives are met.
The IHS is currently reviewing its Human Resources procedures and
moving from a segregated Area by Area approach to a one Human Resource
``warehouse'' approach. This will allow the IHS to streamline its
processes resulting in a more efficient hiring process. The IHS also
has several legislative proposals in the current FY 2025 President's
budget request for IHS. For example, we have a legislative proposal
aimed at addressing some of the time requirements for IHS scholarship
and loan repayment recipients to entice such recipients to remain with
the IHS. We also seek parity with certain Veteran's Affairs hiring
authorities, such as the title 38 authorities, that will allow IHS to
be competitive in offering higher salaries to potential health-care
providers seeking to work for the IHS. The IHS is also prioritizing
human resource information technology optimization and modernization.
System optimization will streamline and more easily allow for efficient
information flow. IHS, in concert with OASH, is also strategizing
improvements in the placement and hiring of Public Health Service
Officers.
______
Questions Submitted by Hon. Tim Scott
Question. In February of this year, I joined Senator Blackburn in
sending a letter to the Centers for Medicare and Medicaid Services on
the proposed Ensuring Access to Medicaid Services rule. The rule
mandates that at least 80 percent of reimbursements for home services
must be directed toward front-line worker wages and benefits. States
can determine their percentages for payments on direct-care workers but
there are currently no States that have an 80-percent requirement. The
letter expresses concerns regarding no official data analysis on how
this proposal would impact the Medicaid system. States, such as my home
State of South Carolina, have flagged that they expect it will harm
provider networks and beneficiary access. The South Carolina Home Care
and Hospice Association has weighed in on the rule and has said, ``This
blanket, one-size-fits-all approach will likely force agency closures,
unfortunately reducing access to care.'' In the agency's response to
this letter, CMS claims that this rule was based upon feedback from
States.
Can you please tell me which States thought this rule would be a
good idea and would not risk access to rural care for seniors during an
already dire workforce shortage?
Answer. On April 27, 2023, CMS issued the Ensuring Access to
Medicaid Services proposed rule. A substantive component of this
proposed rule focuses on improving access to, and the quality of, home
and community-based services (HCBS). Over the past several decades,
HCBS have become a critical component of the Medicaid program and are
part of a larger framework of progress toward community integration of
older adults and people of all ages with disabilities that spans
efforts across the Federal Government. The changes proposed in this
rule are intended to strengthen necessary safeguards to ensure health
and welfare, promote health equity for people receiving Medicaid-
covered HCBS, and achieve a more consistent and coordinated approach to
the administration of policies and procedures across Medicaid HCBS
programs. CMS presumes that references to the ``80/20 proposal'' are
references to the HCBS payment adequacy policy CMS proposed in this
rule, as further described below.
Access to most HCBS generally requires hands on and in-person
services to be delivered by direct care workers. However, direct care
worker shortages are impacting beneficiaries' access to services. In an
effort to address direct care workforce shortages, CMS proposed to
require that States ensure that providers spend at least 80 percent of
Medicaid payments for homemaker, home health aide, and personal care
services on compensation for direct care workers. We believe that this
proposal would not only benefit direct care workers but also
individuals receiving Medicaid HCBS. We believe supporting and
stabilizing the direct care workforce will result in better qualified
employees, lower turnover, and a higher quality of care.
This proposal was based on feedback from States that have
implemented similar requirements for payments for certain HCBS, such as
Minnesota and Illinois. These States reported to us through various
public engagement activities that similar requirements have had their
intended effect of ensuring that a sufficient portion of the payment
for Medicaid HCBS goes to compensation for the direct care workforce.
These States also indicated an 80-percent threshold is an appropriate
threshold that takes into account the expected portion of payments that
are necessary for provider administrative and other costs, aside from
direct care worker compensation. CMS proposed compensation to be
defined as salary, wages, and other remuneration as defined by the Fair
Labor Standards Act and implementing regulations; benefits (such as
health and dental benefits, sick leave, and tuition reimbursement); and
the employer share of payroll taxes for direct care workers delivering
HCBS.
Additionally, this proposed rule would require the establishment of
an Interested Parties Advisory Group, to advise and consult with the
State on payment rates for direct-care workers. This group would
include, at a minimum, direct-care workers, beneficiaries and their
authorized representatives, and other interested parties.
Input from stakeholders is an important contribution to CMS's
policymaking process and CMS is carefully considering all comments
received during the comment period on this proposed rule as we work to
develop a final rule.
Question. In 2023, I, along with other members of the Senate
Finance Committee, sent a letter to the Centers for Medicare and
Medicaid Services expressing concerns with several policies included in
the proposed rule ``Misclassification of Drugs, Program Administration
and Program Integrity Updates Under the Medicaid Drug Rebate Program''
(NPRM). The NPRM fails to provide a patient-oriented justification for
its proposed price verification survey. The NPRM seeks to establish a
drug price verification survey process for certain ``high-cost''
covered outpatient drugs, including cell and gene therapies. In mid-
February Senate Finance Committee members received a response that was
simply an acknowledgement of our letter.
I still would like to know--what could be the unintended
consequences of the proposed Medicaid Drug Rebate policy? CBO has said
in past reports that changes in pricing regulations would likely change
prices to other purchasers.
Do you see any instances where patients may be adversely affected?
My concern is that manufacturers may pull back discounts from certain
entities to mitigate the ``stacking'' effect. Won't that result in
patients paying more out of pocket?
Answer. CMS is currently in the rulemaking process and cannot
comment on or speculate about any potential changes to the proposed
policies or when a final rule may be issued. As always, we are closely
reviewing the comments received in response to the proposed rule. Input
from stakeholders is an important contribution to CMS's policymaking
process, and we are now considering the abundance of comments we
received during the public comment period.
Question. Cell and gene therapies have the potential to transform
health-care delivery, offering treatments and cures for previously
incurable diseases, such as sickle cell disease. With the recent Food
and Drug Administration approval of two gene therapies for sickle cell
disease, the Medicaid Drug Rebate policy risks disclosing proprietary
information without remedying the underlying statutory and regulatory
barriers to value-based coverage arrangements for gene and cell
therapies under Medicaid.
How are you ensuring that changes and requirements proposed in the
``Misclassification of Drugs, Program Administration, and Program
Integrity Updates Under the Medicaid Drug Rebate Program'' will not
limit Medicaid beneficiary access to gene therapies, especially those
approved in December for sickle cell disease, and ensuring that changes
do not undermine the operation or intent of the CMMI Gene and Cell
Therapy Access Model?
How would the proposed rule impact Medicaid's ability to enter into
value-based payment arrangements for novel, curative treatments that
have recently been approved?
Answer. In the proposed rule, CMS proposed to use this authority
now because of the introduction of higher-cost drugs and therapies to
the market, such as cell and gene therapies, which have significantly
impacted States' Medicaid budgets. Our proposal to survey manufacturers
for certain information on specific covered outpatient drugs (CODs),
and our proposal to make certain manufacturer information publicly
available in a central location (unless it is proprietary), would make
the manufacturer pricing process more understandable to CMS and to
States as they establish and negotiate payment for Medicaid CODs
consistent with section 1902(a)(30)(A) of the act. It also would give
States another tool with which to help manage these extremely expensive
drugs. This information should allow a State to understand the value of
the drug as compared to its price, and better understand the impact of
the drug on its budget. In addition, the use of this authority may help
assure Medicaid beneficiary access to these important therapies.
We proposed to exclude those CODs that are subject to other CMS
drug pricing initiatives in which participating manufacturers would
negotiate directly with Medicare or Medicaid. Therefore, the CODs of
manufacturers participating in the Center for Medicare and Medicaid
Innovation's Cell and Gene Therapy Access Model (which is a result of
the President's signed executive order) would not be subject to the
price verification survey. In addition, when choosing the drugs subject
to the survey, CMS will consider narrowing the list based on State-
specific Medicaid program input regarding manufacturer efforts to lower
drug prices (including through mechanisms such as subscription models,
value-based purchasing arrangements under the multiple best price
approach, or other purchasing arrangements favorable to the Medicaid
program).
We note that CMS continues to review comments received on the
proposed rule as we work toward issuing a final rule.
Question. Regarding drug shortages, the Finance Committee released
a white paper in January in which we found that generic drugs typically
make up two-thirds of all drug shortages in the U.S. And, in December
of 2023, the committee held a hearing on drug shortages, during which
we heard extensive testimony indicating that race-to-the-bottom pricing
for generic drugs serves as the primary underlying driver of many of
the ongoing drug shortages faced by patients in America today. Generic
manufacturers seem to be facing intense pressure to reduce prices and
often face contract terms from purchasers that render revenue
unpredictable. As a result, generic prescription drug supply chains can
experience manufacturer exits, low production, or stoppages required by
regulators. This concern seems to be underscored by the recent Federal
Trade Commission RFI that examines the market concentration of health-
care group purchasing organizations (GPOs) and drug wholesalers and how
they ``impact the overall generic pharmaceutical market,'' including
how both entities may influence the pricing and availability of
pharmaceutical drugs.
What steps is the Department taking to address the issue of drug
shortages and, more specifically, have you contemplated any payment or
contracting changes in Medicare or Medicaid that would address the
precarious economic position of generic drug manufacturers?
Answer. HHS recognizes the severe patient impact from the
persistent problem of chronic drug shortages that have most frequently
impacted inexpensive generic drugs, particularly sterile injectables.
HHS is taking a coordinated approach to help address economic root
causes of shortages.
In November 2023, HHS announced the establishment of a new Supply
Chain Resilience and Shortage Coordinator role responsible for
coordinating efforts across the Department that advance the resilience
of medical product and food supply chains and accelerate the
Department's response to related shortages. Institutionalizing this
coordination across the Department will help HHS meet its long-term
supply chain resilience and shortage mitigation goals. In addition, FDA
on an ongoing basis works to identify shortage risks and determines
actions that can prevent or mitigate patient impact, such as
prioritizing review of manufacturer submissions or working with
manufacturers to increase supply. ASPR also led the development of an
Essential Medicines Supply Chain and Manufacturing Resilience
Assessment to identify supply chain vulnerabilities in a critical
medicines list and has invested, through the Industrial Base Management
and Supply Chain (IBMSC) Office, targeted funds to bolster domestic
manufacturing capabilities for essential medicines.
CMS is also taking steps to help align certain incentives to
bolster supply chain resilience and further promote adoption of
resilient supply chain practices. As discussed in the Calendar Year
2024 Outpatient Prospective Payment System (OPPS) final rule, CMS
solicited public comment on providing separate payment under the
Medicare Inpatient Prospective Payment System (IPPS), and potentially
the OPPS, for establishing and maintaining access to a buffer stock of
essential medicines to foster a more reliable, resilient supply (88 FR
82127-30).
CMS also noted in the CY 2024 OPPS final rule that as part of the
agency's initial efforts, CMS intends to propose new Conditions of
Participation in forthcoming notice and comment rulemaking addressing
hospital processes for pharmaceutical supply (88 FR 82130). CMS
continues to review the comments received to consider ways the Medicare
program can promote hospital resilient supply chain practices to help
mitigate the impact of drug shortages on patients.
Question. Related to drug shortages, the committee found in its
January white paper that Medicaid payment for prescription drugs may be
putting unintended, downward pressure on generic medicines, including
those that are prone to shortages. More specifically, there is some
concern that the application of inflation penalties placed on generics
under the Medicaid Drug Rebate Program (MDRP) presents challenges for
manufacturers in addressing shortages given many of the broader
economic issues they face, which have been raised by this committee and
the Federal Trade Commission.
Has the Department explored the extent to which reforms of certain
aspects of the MDRP can relieve drug shortages?
Answer. CMS administers the Medicaid Drug Rebate Program (MDRP) in
accordance with Federal statute and regulations. With limited
exceptions, if a drug manufacturer wants payment to be available under
Medicaid for their covered outpatient drugs (CODs), the manufacturer
must participate in the MDRP, and agree to pay rebates for CODs
dispensed and paid for under the Medicaid State Plan. The amount of the
rebate is determined by a formula set forth in section 1927(c) of the
Social Security Act. Generally, the formula to calculate the rebate
that applies to a particular drug depends on whether the drug is
classified as (1) a single source drug or innovator multiple source
drug (commonly referred to as a brand-name drug); or (2) other drugs,
which include non-innovator multiple source drugs, commonly referred to
as generic drugs, among others. In accordance with section 1927(c) of
the act and Federal Regulations at 42 CFR 447.509, the rebate
calculation for a particular COD may also include an additional
inflationary component to account for increases in the drug's Average
Manufacturer's Price.
Question. I'm very concerned about the proposed cuts to the
Medicare Advantaged program in CMS Rate Notice for Plan Year 2025.
According to a recent study by the Berkley Research Group, seniors who
chose Medicare Advantage over Fee-for-Service will on average
experience a $33 per month benefit cut. In January of this year, I
coled a letter with Senator Cortez Masto with over 60 cosigners from
both sides of the aisle supporting Medicare Advantage.
I strongly encourage HHS and CMS to reconsider cuts to this
program, and to work with these groups to make the MA program stronger
and more sustainable for the 51 percent of Medicare beneficiaries that
have chosen MA for their health coverage.
CMS released proposed negative Medicare Advantage rates that do not
keep up with inflation or rising medical costs. CMS proposed a -.16-
percent overall payment environment for 2025. As part of the proposed
negative payment environment, CMS incorporated a 2.44-percent growth
rate into the payment methodology. Both external and government
analyses show that medical costs are increasing and far above CMS's
estimates, such as CMS's Office of the Actuary projects an average
Medicare annual expenditure growth of 7.5 percent for the period 2022
through 2031 and specifically calls out that in 2025 Medicare spending
growth will be 8.9 percent. Along with this, the Congressional Budget
Office projects that Medicare spending is expected to grow by 8 percent
in 2024.
It seems important to ensure the Medicare Advantage payment
environment reflects these increased cost pressures, especially now
that Medicare Advantage serves more than 50 percent of Medicare
beneficiaries. Are you accounting for these increased cost pressures in
the 2025 Medicare Advantage final notice?
For 2024, CMS finalized a negative payment environment and enacted
the most significant changes to the program in a decade, including
changes to Medicare Advantage payment through the implementation of a
new risk adjustment model. CMS is phasing in the new Risk Adjustment
Model over a 3-year period and the full impact is yet to be realized.
For 2025, CMS is proposing another year of negative rates.
Are you concerned these year-over-year cuts to the Medicare
Advantage program will negatively impact seniors' benefits and
premiums? What is being done to prevent negative impacts to seniors?
Answer. CMS's release of the Calendar Year 2025 Advance Notice
continues to build on our actions to keep the MA program strong while
improving MA payment accuracy. Medicare Advantage payments from the
government to MA plans are expected to increase by 3.7 percent on
average from 2024 to 2025, as proposed. This is over a $16-billion
increase in expected MA payments for the next year. This expected
increase includes consideration of various elements that impact MA
payment, such as growth rates of underlying costs, 2024 Star Ratings
for 2025 quality bonus payments, continued phase-in of risk adjustment
model updates that were implemented in CY 2024, and increases to risk
scores because of MA risk score trend, which can be driven by a number
of factors including MA demographics and coding patterns. This increase
represents the average expected payment update across plans, and thus,
there will be variation among plans in terms of their plan-specific
payment impacts, including plans that would see a larger or smaller
impact year over year. As in past years, the projected change in
payment can change between the Advance Notice and Rate Announcement,
published no later than April 1, 2024.
If finalized, CMS anticipates stable premiums and benefits for
individuals for CY 2025, as was the case for offerings in CY 2024,
which was the first year of the updated risk adjustment model
implementation. For CY 2024, average premiums and benefits for MA
remained stable. The MA average monthly plan premium remained stable
with an increase of less than $1 on average, while plan choice and
average supplemental benefit offerings across plans increased.
Question. The Inflation Reduction Act (IRA) made changes to
Medicare Part D that will increase plan sponsors' liability for costs
in the catastrophic phase beginning in 2025. As a result, plans have
additional incentive to apply utilization management, including step
therapy, in order to limit their expenditures and such actions could
adversely impact patients access to timely and appropriate care. It is
critical that CMS takes proactive steps to protect beneficiaries,
including providing clear direction to health plans and pharmacy
benefit managers, to ensure timely patient access to therapy. The
magnitude of adverse impacts could be far reaching to millions of
patients when you consider how many enrollees depend on medication to
treat a range of conditions.
How is CMS monitoring changes in formulary design to ensure that
beneficiaries maintain timely access to appropriate therapies?
Answer. CMS is continuing to work to improve the Medicare Advantage
and Part D prescription drug programs and maintain high-quality health-
care coverage choices for all Medicare enrollees.
CMS maintains, and will continue to maintain, a robust clinical
formulary review process to ensure that all Medicare Part D plans meet
applicable formulary requirements. Consistent with the requirements at
Sec. Sec. 423.120(b)(2) and 423.272(b)(2)(i), CMS evaluates formularies
based on the sufficiency of categories and classes, tier placement, and
utilization management restrictions. This review process is based in
part on section 1860D-11(e)(2)(D)(i) of the Social Security Act, which
authorizes CMS to approve a prescription drug plan only if the agency
``does not find that the design of the plan and its benefits (including
any formulary and tiered formulary structure) are likely to
substantially discourage enrollment by certain Part D eligible
individuals under the plan.'' In addition, under Sec. 423.272(b)(2)(i),
``CMS does not approve a bid if it finds that the design of the plan
and its benefits (including any formulary and tiered formulary
structure) or its utilization management program are likely to
substantially discourage enrollment by certain Part D eligible
individuals under the plan.'' Furthermore, Sec. 423.120(b)(2)(iii)
requires each Part D plan formulary to ``include adequate coverage of
the types of drugs most commonly needed by Part D enrollees, as
recognized in national treatment guidelines.'' In addition,
Sec. 423.120(b)(1)(v) requires that in making decisions about formulary
design, the entity designing the formulary must base ``clinical
decisions on the strength of scientific evidence and standards of
practice.''
Additionally, CMS requires Part D sponsors to submit utilization
management requirements applied at point of sale, such as prior
authorization, step therapy, and quantity limits not based upon the
FDA's maximum daily dose limits, as part of their Health Plan
Management System formulary submission. Sponsors must perform adequate
oversight of their PBMs and other delegated entities to verify that
they are complying with all CMS requirements and not causing
beneficiary harm due to impermissible delayed or denied access to Part
D drugs.
We will continue to monitor year-over-year formulary and
utilization management changes to assess if changes from the redesigned
Part D benefit have the potential to reduce access to vital
medications.
Question. For the first time since the enactment of the Bayh-Dole
Act in 1980, the Biden administration has discovered an authority to
use so-called ``march-in rights'' as a mechanism for government-imposed
price controls. No previous administration, including the current one,
has ever found a basis for doing this. In fact, Senators Bayh and Dole
wrote ``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.''\45\
---------------------------------------------------------------------------
\45\ Birch Bayh and Robert Dole, ``Our Law Helps Patients Get New
Drugs Sooner,'' The Washington Post (April 11, 2002) Available at:
https://www.washingtonpost.com/archive/opinions/2002/04/11/our-law-
helps-patients-get-new-drugs-sooner/d814d22a-6e63-4f06-8da3-d9698552f
a24/.
Where does the administration believe it gets the authority for
---------------------------------------------------------------------------
this radical rewrite of existing law?
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 fully committed to implementing the law to uphold these aims
and support the innovation needed to deliver new safe and effective
drugs to patients. To that end, HHS has partnered with the Department
of Commerce to review cases in which the use of march-in authority, as
laid out in the Bayh-Dole Act, would be appropriate by clearly
articulating the guiding criteria and processes for making
determinations where different factors, including price, may be a
consideration in the agencies' assessments.
Question. In 2020, you organized a letter signed by 36 Attorneys
General urging the Secretary of Health and Human Services to exercise
march-in rights on the drug Remdesivir even though the patents
associated with that drug lacked the requisite Federal Interest
Statement required under the Bayh-Dole Act. In fact, the Chief Patent
Counsel for the U.S. Army Medical Research and Development Command,
said ``[a]lthough USAMRIID performed extensive and critical screening
and testing for Gilead, testing a compound and finding that it is
indeed an effective antiviral compound does not qualify USAMRIID as a
joint inventor of the compound.''\46\ The Government Accountability
Office reported ``[f]ederally supported Remdesivir research conducted
by CDC, DOD, NIH, and NIH-funded universities has not resulted in
government patent rights, because, according to agency and university
officials, Federal contributions to the research did not generate new
inventions. In addition, Gilead entered research collaborations with
Federal agencies and universities with a portfolio of existing patents
and patent applications, including for the remdesivir compound, which
would have left little room for the agencies to generate their own
patents.''\47\
---------------------------------------------------------------------------
\46\ Christopher Rowland, ``Taxpayers Paid to Develop Remdesivir
but Will Have No Say When Gilead Sets the Price,'' The Washington Post
(May 26,2020) Available at: https://www.washingtonpost.com/business/
2020/05/26/remdesivir-coronavirus-taxpayers/.
\47\ Government Accountability Office, ``Biomedical Research:
Information on Federal Contributions to Remdesivir,'' GAO-21-272 (March
31, 2021) Available at: https://www.gao.gov/products/gao-21-
272#::text=Remdesivir%20was%20the%20first%20drug,and%20related%20agency
%2
0patent%20rights.
It's a simple matter to look up a patent and determine whether it
has a Federal interest statement making it subject to march-in. Did you
---------------------------------------------------------------------------
or any member of your staff bother to check? If not, why not?
Do you now acknowledge that your demand that HHS march-in on
Remdesivir was made without any basis in law or fact?
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 the agencies' assessments.
Question. There are very few drugs where all the associated patents
have a Federal interest statement enabling the government to march in
and license another party to make a copy.
Has the Biden administration determined how many drugs would be
subject to march-in if the law allowed it to be used in this manner? If
so, could you share that information with the committee?
Answer. NIST is the agency with authority to interpret and
promulgate implementation of the march-in authority. HHS is working
with NIST, through the Department of Commerce, to finalize the
implementation framework described above.
______
Questions Submitted by Hon. Benjamin L. Cardin
Question. As you know, our oral health is closely tied to our
physical health. Over the last 3 years, the Biden-Harris administration
has taken significant steps to promote access to oral health care.
While Medicare dental coverage remains considerably limited, in 2023,
CMS clarified that in certain situations Medicare beneficiaries can
access medically necessary treatments for oral health. This was a move
Senator Stabenow and I long advocated for.
I was also pleased to see that CMS created a process to evaluate
clinical evidence for additional dental services to determine whether
they are medically necessary for beneficiaries, and I look forward to
CMS continuing to examine the data to ensure coverage for all medically
necessary oral health services.
Will you continue to use existing HHS authorities to ensure that
oral health care is accessible to Medicaid and Medicare beneficiaries
when it is medically necessary and work to reduce access disparities,
including at-risk populations like communities of color, low-income
individuals, and those living in rural communities?
What strategies is your agency implementing to ensure that children
on Medicaid and CHIP are receiving the appropriate oral health
screenings and treatment, particularly children with disabilities?
With all of this new activity, is CMS working to expand upon its
dental expertise and resources within the agency to support
implementation? What additional support is needed to help implement,
oversee, and monitor CMS's dental efforts?
Answer. CMS believes that dental health is an important part of
people's overall health. Medicare statute generally precludes payment
under Medicare Parts A or B for any expenses incurred for coverage,
items, and services in connection with the care, treatment, filling,
removal, or replacement of teeth or structures directly supporting
teeth, but there are some exceptions. Medicare has paid for dental
services in some clinical circumstances when the dental services are
inextricably linked to the clinical success of covered medical
services. The Centers for Medicare and Medicaid Services codified that
policy in the agency's regulations. CMS also adopted a set of examples
of clinical scenarios under which Medicare payment under Parts A and B
can be made for certain dental services furnished in either the
inpatient or outpatient setting, including for dental exams and
necessary treatments prior to the treatment for head and neck cancers,
beginning in CY 2024.
In the CY 2024 Medicare Physician Fee Schedule final rule, CMS
added more examples in regulations of clinical scenarios under which
Medicare Part A and Part B payment can be made for dental services.
Additionally, CMS finalized to make payment for certain dental services
inextricably linked to covered services used to treat cancer, including
chemotherapy services, Chimeric Antigen Receptor T- (CAR-T) Cell
therapy, and the use of high-dose bone modifying agents (antiresorptive
therapy). These policies increase access to important dental care that
can improve the success of these cancer-related treatments. CMS will
continue to explore whether there are additional clinical scenarios
where dental services are inextricably linked to the clinical success
of covered medical services.
Medicaid covers dental services for eligible child enrollees as
part of a comprehensive set of benefits, referred to as the Early and
Periodic Screening, Diagnostic and Treatment (EPSDT) benefit. Dental
services covered as part of EPSDT must include relief of pain and
infections, restoration of teeth, and maintenance of dental health. The
EPSDT benefit requires that all services the State could cover under
section 1905(a) of the Social Security Act (Act) must be covered for an
EPSDT-eligible child if determined medically necessary. States
determine medical necessity. If a condition requiring treatment is
discovered during a screening, the State must cover any necessary
services to treat that condition, whether or not such services are
covered for adults or included in a State's Medicaid plan, as long as
the services could be covered under section 1905(a) of the act. Each
State is required to develop a dental periodicity schedule in
consultation with recognized dental organizations involved in child
health care. Dental services may not be limited to emergency services
for children entitled to EPSDT.
States that provide CHIP coverage to children through a Medicaid
expansion program are required to cover the EPSDT benefit. Dental
coverage in separate CHIP programs is required to include coverage for
dental services ``necessary to prevent disease and promote oral health,
restore oral structures to health and function, and treat emergency
conditions.'' States are also required to post a listing of all
participating Medicaid and CHIP dental providers and benefit packages
on InsureKidsNow.gov.
Improving oral health outcomes for children and adolescents in
Medicaid and CHIP is a priority for CMS. Tooth decay is one of the most
common chronic conditions of childhood, can have long-lasting effects
on healthy growth and development, and is more prevalent among children
who are from low-income families. In recognition of this priority, CMS
reports on quality improvement efforts and progress in this area each
year. Furthermore, the Core Set of Children's Health Care Quality
Measures for Medicaid and CHIP (Child Core Set) includes three measures
that focus on measuring access to high quality and appropriate dental
and oral health services. These measures include comprehensive or
periodic oral evaluation, receipt of dental sealants and receipt of
topical fluoride. States began reporting this information on voluntary
basis in 2022, and reporting becomes mandatory in 2024.
States also have flexibility to determine what dental benefits are
covered for adult Medicaid enrollees. While most States cover at least
emergency dental services for adults, less than half of the States
currently cover comprehensive dental care. There are no minimum
requirements for adult dental coverage in Medicaid. In order to help
ensure that children on Medicaid and CHIP are receiving appropriate
oral health screenings and treatment, CMS launched the Oral Health
Initiative (OHI) in 2010 and set national and State-specific goals to
improve Medicaid-enrolled children's use of preventive dental care, and
invited State Medicaid agencies to develop State Oral Health Action
Plans (SOHAPs) as a roadmap to achieving their goals. In 2020, CMS
announced the next phase of the OHI to support continued progress and
drive further quality improvement, and continued to offer technical
assistance to States on refreshing or developing SOHAPs and identifying
best practices to help States move toward their OHI goals. From 2020-
2023, a CMS learning collaborative, Advancing Oral Health Prevention in
Primary Care, supported State Medicaid and CHIP agencies' efforts to
improve children's oral health. CMS looks forward to working with both
States and Congress to continue improving access to important oral
health-care services.
Question. According to HRSA, there are over 103,000 men, women, and
children on the national waiting list, and around 17 people die each
day while waiting for an organ transplant. This problem is even more
acute for people of color and people in rural communities. For example,
Black Americans are less likely to be given opportunities to consider
donation, contributing to the shortage of available organs.
Over the last 2 years, Congress has worked with HHS, including CMS
and HRSA to make historic reforms to the organ procurement transplant
network (OPTN). I was pleased to hold a subcommittee hearing and colead
legislation to modernize the transplant system, which President Biden
signed into law last fall, titled the Securing the U.S. Organ
Procurement and Transplantation Network Act. My colleagues, Chairman
Wyden, Senators Grassley, Young, and Cassidy have been excellent
partners in our effort to make our transplant system work for all
Americans.
The President's budget takes steps in this direction by investing
for a more fair, well-managed, and high functioning organ transplant
system in this country, and highlighting priority issues in organ
donation, including transparency.
Can you comment on what policies HHS and HRSA will support to
require OPOs to be more transparent, including whether HRSA will
require OPOs to publish data about donated organs, so we can tackle
health disparities around organ donation?
Answer. HHS is taking transformational steps to modernize the
critical organ matching technology while increasing transparency and
accountability by issuing new data reporting requirements to better
address pre-waitlist and organ procurement practices. In February, HRSA
directed the current OPTN vendor to standardize and update data
reporting on referral to transplant center, time-to-patient assessment,
time-to-organ procurement, and other data to allow for greater
accountability in organ procurement and transplant practices across
geography and populations and facilitate improved system performance.
Additional details on this data directive are provided on the OPTN
website.
This important work on pre-waitlist practices will help address
inequities in the transplant waitlist process by reducing racial and
ethnic variation both in patient referrals and in organ procurement.
Question. In 2020, HHS finalized a new rule to hold organ
procurement organizations (OPOs) accountable for their performance,
meaning that failing OPOs will lose their contracts to higher
performers who can better serve patients. Since HHS finalized this
rule, OPOs have continued to lobby against enforcement of the rule,
including through misinformation campaigns.
Will HHS commit today to enforcing the OPO rule, without any delay
or weakening, at the end of the current OPO contract cycles, so that
every part of the country can be served by a high-performing OPO?
Answer. The role of OPOs is critical to ensuring that the maximum
number of transplantable organs are available to seriously ill people
who are on a waiting list for an organ transplant. The 2020 OPO final
rule was an important step forward in improving OPO performance and
increasing accountability for these organizations to ensure lifesaving
organs reach potential recipients.
CMS established and implemented two new outcome measures in the
2020 OPO final rule in accordance with the authorizing legislation to
drive improved organ procurement that results in increased
transplantation, reduces organ nonuse, and increases the number of
lives saved. These outcome measures are based on objective and reliable
data that compares each OPO's performance to the top-performing OPOs,
and then stratifies OPOs into three different tiers based on their
performance, with the lowest performers (those in tier 3) being
decertified from the program. As specified in the final rule, CMS will
conduct annual assessments of OPO performance. This will provide more
frequent feedback to OPOs on their performance. The outcome assessments
will be based on the most recent 12 months of data. For the first 3
years of the certification cycle, CMS will identify any low performing
OPOs (those below the top performing rate) and these entities are
required to revise their quality assessment and performance improvement
program in order to improve their performance. CMS will also provide
OPOs with feedback on their performance annually allowing time to make
the needed changes to drive improvements. While the certification cycle
is at least 4 years, we expect OPOs to continuously improve year over
year in order to maximize the number of available organs for potential
recipients. CMS provides data every year on the OPOs' tier status in
order for them to continue to improve performance and address any
barriers that they may have. However, the agency bases recertification
on the most recent 1 year of performance data.
Additionally, CMS is offering technical assistance to chronically
low-performing OPOs to help them in improving performance. CMS is
currently providing OPOs the opportunity to participate in the End-
Stage Renal Disease Treatment Choices Learning Collaborative, a joint
quality improvement program from CMS in collaboration with the Health
Resources and Services Administration. The learning collaborative is
based on the success of the 2003 Organ Donation Breakthrough
Collaborative and the 2016-2018 Organ Procurement and Transplantation
Network Collaborative Innovation and Improvement Network project. The
program provides technical assistance to several stakeholders,
including OPOs, with three aims: to increase the number of deceased
donor kidneys transplanted, to decrease the current national organ non-
use rate of all procured kidneys, and to increase the percentage of
change for kidneys recovered for transplant with a high kidney donor
profile index.
While CMS is working closely with OPOs in an effort to boost their
performance, we will take necessary action at the end of the current
certification period if they fail to meet established performance
benchmarks. CMS will enforce requirements during the recertification
process that will occur in 2026. While there is currently no formal
appeals process for tier assignment, CMS provides OPOs the opportunity
to preview their tier assignment and raise any concerns if they believe
the information is incorrect. If an OPO were to be decertified for any
reason, CMS provides the OPO an opportunity to appeal the
decertification on substantive and procedural grounds. CMS continues to
work to improve the overall organ donation and transplantation system
to ensure that all lifesaving organs reach potential recipients.
As stated in the Fall 2023 Unified Agenda of Regulatory and
Deregulatory Actions, we are developing a proposed rule regarding the
standards used to evaluate and recertify OPOs. Since the OPO final
rule, CMS has received feedback from stakeholder listening sessions and
continued public comment on the rule, including comments received from
a CMS Request for Information on OPO and transplant system concerns
published in December 2021. As a result of the feedback, we are
reviewing our OPO competition and decertification processes, and any
changes would be made through future rulemaking. Any revisions will
continue to hold OPOs responsible for improved performance.
Question. At the end of the second quarter of 2023, the American
Society of Health-System Pharmacists identified 309 active, ongoing
drug shortages--the highest number in nearly a decade.
In 2022, legislation I championed with Senator Collins was
incorporated in the FY 2023 Omnibus, which requires FDA to update its
guidance on stability testing tied to shelf-life expiration dates. One
part of my proposal that was not included was the authority for FDA to
levy civil money penalty if a manufacturer fails to comply. I look
forward to continuing to work with you on that issue.
Can you talk about the broader efforts across HHS and partnerships
across government you are implementing to mitigate and prevent drug
shortages?
Answer. HHS recognizes the severe patient impact from the
persistent problem of chronic drug shortages that have most frequently
impacted inexpensive generic drugs, particularly sterile injectables.
HHS is taking a coordinated approach to help address economic root
causes of shortages.
In November 2023, HHS announced the establishment of a new Supply
Chain Resilience and Shortage Coordinator role responsible for
coordinating efforts across the Department that advance the resilience
of medical product and food supply chains and accelerate the
Department's response to related shortages. Institutionalizing this
coordination across the Department will help HHS meet its long-term
supply chain resilience and shortage mitigation goals. In addition, FDA
on an ongoing basis works to identify shortage risks and determines
actions that can prevent or mitigate patient impact, such as
prioritizing review of manufacturer submissions or working with
manufacturers to increase supply. ASPR also led the development of an
Essential Medicines Supply Chain and Manufacturing Resilience
Assessment to identify supply chain vulnerabilities in a critical
medicines list and has invested, through the Industrial Base Management
and Supply Chain (IBMSC) Office, targeted funds to bolster domestic
manufacturing capabilities for essential medicines.
CMS is also taking steps to help align certain incentives to
bolster supply chain resilience and further promote adoption of
resilient supply chain practices. As discussed in the Calendar Year
2024 Outpatient Prospective Payment System (OPPS) final rule, CMS
solicited public comment on providing separate payment under the
Medicare Inpatient Prospective Payment System (IPPS), and potentially
the OPPS, for establishing and maintaining access to a buffer stock of
essential medicines to foster a more reliable, resilient supply (88 FR
82127-30).
CMS also noted in the CY 2024 OPPS final rule that as part of the
agency's initial efforts, CMS intends to propose new Conditions of
Participation in forthcoming notice and comment rulemaking addressing
hospital processes for pharmaceutical supply (88 FR 82130). CMS
continues to review the comments received to consider ways the Medicare
program can promote hospital resilient supply chain practices to help
mitigate the impact of drug shortages on patients.
Question. On President Biden's first day in office, he signed an
executive order directing a whole-of-government approach to addressing
racial equity and disparities among underserved communities. The
President built on that through an additional executive order shortly
after.
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 elevated 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.
How is the administration working to promote health equity and
eliminate health disparities across HHS programs?
Answer. The National Institutes of Health (NIH) are advancing
health equity by supporting research to improve minority health and
reduce health disparities. These efforts are led by the National
Institute on Minority Health and Health Disparities (NIMHD). Through an
agency-wide plan, NIMHD coordinates research and activities on minority
health and health disparities, supports training and capacity building,
and fosters collaborations and partnerships. Research projects totaling
approximately $5 billion across NIH support minority health and health
disparities science.
NIH prioritizes minority health and health disparities research
through collaborative initiatives and programs. For example, the
Community Engagement Alliance (CEAL) initiative focuses on community-
engaged research, which is a key component of the initiative's
effectiveness in providing critical support on vaccination,
therapeutics, and participation in clinical trials among those
disproportionately affected by the COVID-19 pandemic. Moving forward,
NIH is applying the CEAL research models, resources, lessons learned,
and best practices to other important areas of population health such
as prevention and management of chronic diseases.
The NIH Science collaborative for Health disparities and artificial
intelligence bias Reduction (ScHARe) initiative, led by NIMHD in
collaboration with the National Institute of Nursing Research, is an
innovative cloud-based platform for population science, including
social determinants of health (SDOH) and data sets designed to
accelerate research on health disparities, health and health-care
delivery outcomes, and artificial intelligence (AI) bias mitigation
strategies. ScHARe aims to promote broad participation among data
science researchers, including those from underrepresented racial and
ethnic groups and women, provide opportunities for collaborations,
trainings, and mentorship, and advance health disparities research by
leveraging big data and ethical AI.
The NIH Common Fund Community Partnerships to Advance Science for
Society (ComPASS) program is supporting multilevel structural
interventions in community-driven research projects focused on SDOH and
fostering collaborative partnerships between communities and
researchers. In FY 2023, the ComPASS program made 25 awards directly to
community organizations and funded a coordinating center, totaling
approximately $171 million over 5 years, pending the availability of
funds. Examples of ComPASS-supported research projects that focus on
populations experiencing health disparities include: increasing access
to healthy foods in underserved rural communities; improving telehealth
models for preventative screening and disease management among
agricultural workers; and investigating early childcare strategies to
improve mental health for children and caregivers.
In addition to these select research activities and efforts, NIH
remains committed to working with HHS partners to ensure that
eliminating health disparities remains a priority for NIH and across
HHS.
Question. The last 4 years have shown the benefits of telehealth
for people across the United States. 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 the
Senate Finance Committee Working Group on telemental 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 equal access to high quality care through telehealth?
As we look to make permanent telehealth policies, what additional
tools do you need from Congress?
Answer. HHS and CMS continually consider how to best ensure access
to medically necessary items and services and makes changes where
appropriate and permissible under our statutory authority. We recognize
the vital role that telehealth can play in the delivery of care,
particularly among populations that are underserved. We implemented
section 4113 of the Consolidated Appropriations Act, 2023, which
extended many telehealth flexibilities adopted during the public health
emergency for COVID-19 through December 31, 2024. Additionally, through
notice-and-comment rulemaking, the CMS solicited public comment and
implemented regulatory changes that have permanently expanded certain
telehealth policies that are within the agency's authority to modify.
Some changes to Medicare telehealth policy would require legislative
action to amend the statute, and we look forward to our continued work
with Congress on this crucial issue.
Question. Gun violence is an issue that plagues communities across
the country, including many in my home State of Maryland. Aside from
the obvious devastating human impact of this violence, according to
Everytown for Gun Safety, gun deaths and injuries cost Maryland over
$10 billion each year.
I am proud to be working on a bill that would provide guidance to
States regarding Medicaid reimbursement for furnishing community
violence prevention services and treatments that aim to ease the burden
this traumatic violence places on communities. Hospitals in my State,
including Shock Trauma and University of Maryland Capital Region
Medical Center, are doing great work, partnering with the community to
reduce gun violence.
Do you see gun violence as a threat to the health of our
communities and how will the proposed budget support communities to
reduce and prevent it?
Answer. Violence is a serious public health problem that impacts
the health and safety of Americans. Firearm injury is among the 5
leading causes of death for people aged 1-44 in the United States and
is the leading cause of death among children and teens ages 1-19.\48\
In 2022 there were approximately 24,867 homicide-related deaths.
Approximately 19,657 of these were firearm homicides.\49\ In addition,
more people suffer nonfatal than fatal firearm-related injuries. More
than 7 out of every 10 medically treated firearm injuries are from
firearm-related assaults.\50\ The total cost of firearm related
injuries and deaths in the U.S. was $493.2 billion in 2020.\51\
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\48\ Centers for Disease Control and Prevention, National Center
for Injury Prevention and Control. WISQARS--Web-based Injury Statistics
Query and Reporting System. https://www.cdc.gov/injury/wisqars/
index.html.
\49\ Centers for Disease Control and Prevention. WONDER--Wide-
ranging Online Data for Epidemiologic Research. Provisional Mortality
Statistics. https://wonder.cdc.gov/mcd.html
\50\ Dahlberg LL, Haileyesus T. Victimization from gun violence.
in: Schildkraut J, Carter GL, Guns in American Society: An Encyclopedia
of History, Politics, Culture, and the Law. 3rd ed. ABC-CLIO
Publishers, Santa Barbara, CA2022: 885-891.
\51\ Miller GF, Barnett SBL, Florence CS, Harrison KM, Dahlberg LL,
Mercy JA. Costs of Fatal and Nonfatal Firearm Injuries in the U.S.,
2019 and 2020. American Journal of Preventive Medicine, 2024; 66(2):
195-204.
Community violence can cause mental health conditions such as
depression, anxiety, and post-traumatic stress disorder (PTSD). Living
in a community experiencing violence is also associated with increased
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risk of developing chronic diseases.
Community violence is preventable, and CDC is working with partners
and communities to disseminate, implement, and scale-up strategies
based on the best available evidence to create safer communities. CDC's
Resources for Action help communities and States sharpen their focus on
prevention activities with the greatest potential to prevent multiple
forms of violence and their consequences.
The proposed FY 2025 budget provides a total of $2.5 billion over
10 years in mandatory and discretionary funds for Youth and Community
Violence Prevention, including CDC's Community Violence Intervention
initiative. Of this total, the budget assumes $100 million in
discretionary funding per year and $150 million in mandatory funding
per year to support scaling up existing community violence prevention
efforts and implementing and evaluating programs, policies, and
practices based on the best available evidence. With an annual
investment of $250 million, CDC will fund up to 75 cities and
communities in geographic areas with the highest number of homicides or
highest number of homicides per capita to (1) establish a
collaborative, community-driven public health approach to reduce
community violence, and (2) provide technical assistance and support to
these communities. Increased funding for community and youth violence
prevention will also allow CDC to fund additional National Centers of
Excellence in Youth Violence beyond the five currently funded to
develop, implement, and rigorously evaluate innovative strategies to
prevent violence and create safer, healthier family and community
environments for youth.
In addition, the $60 million proposed in the FY 2025 President's
budget for firearm injury and mortality prevention research across NIH
and CDC will be used to fund additional research and evaluation
projects to better understand and prevent firearm-related injuries and
deaths in the United States, and continue efforts to strengthen data at
the local, State, and national level. CDC would also use this increased
funding to expand the very successful near real-time data collection
through the Firearm Injury Surveillance Through Emergency Rooms:
Advancing Violence Epidemiology in Real-Time (FASTER: AVERT) program
nationwide.
Question. I have long been a champion of our country's global
health initiatives, and I am glad to see that this budget requests $10
billion to strengthen health systems globally. After the pandemic, it
became clearer to many how interconnected all of the world's health
systems are.
The U.S. Centers for Disease Control and Prevention play a key role
in global health systems strengthening by exchanging scientific
expertise and data with other nations, working alongside other
agencies, such as the U.S. Agency for International Development and the
State Department.
How will investments from the FY 2024 budget allow HHS to
contribute to global health systems strengthening as a critical
component of pandemic preparedness and global health security?
Answer. CDC is 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 advances
the U.S. Government's newly released Global Health Security Strategy
and National Biodefense Strategy by leading the U.S. Government
response to public health emergencies. CDC experts work alongside
local, regional, and global partners across our global health portfolio
to provide unparalleled expertise in disease data and surveillance,
laboratory systems, public health workforce and institutions, disease
prevention and response, innovation and research, and policy,
communication, and diplomacy.
The most effective and least expensive way to protect Americans
from infectious diseases and other health threats that begin overseas
is to prevent, detect, and respond to outbreaks before they spread to
the United States. Due to CDC's global presence and decades of building
peer-to-peer partnerships, collaboration, and public health networks,
CDC staff are often the ``first call'' by partners abroad about signs
of a potential disease outbreak event. The earlier a disease threat is
identified, the sooner the response can begin to prevent further
spread, including to the United States. In this way, CDC's global staff
further CDC's mission by serving as the United States' first line of
defense against infectious disease threats and their potential
importation.
With the sustained funding, CDC will continue to:
Maintain its role in serving as the U.S. Government's lead agency
for infectious disease outbreak response to keep Americans safe from
the next emerging disease threat.
Prevent, detect, and respond to high consequence threats to the
United States. This includes 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, et cetera),
respiratory pathogens, and vector-borne diseases (diseases from
pathogens spread by mosquitos, ticks, fleas, et cetera). CDC will also
continue to help build and support laboratory and surveillance networks
that can be leveraged to respond to new and emerging global threats to
contain spread.
Work alongside countries and partners to strengthen global public
health systems, including developing and enhancing disease surveillance
systems that enable disease detection, tracking and reporting, as well
as helping to build more effective public health laboratories. In
addition, through CDC's focused efforts to modernize and expand front-
line disease detective training and emergency response capabilities,
CDC will continue help building and supporting global public health
systems to improve health security and protect the health and
livelihoods of the American people.
Build strong cadres of international disease detectives through
training in surveillance, leadership and management, and emergency
response, through the Field Epidemiology Training Program (FETP), and
assist countries in building sustainable public health emergency
preparedness and response capacity through the International Career
Epidemiology Field Officer (I-CEFO) program.
Help countries establish their own public health emergency
management programs to prepare for, respond to, and recover from public
health threats. CDC's programs train government leaders and a country's
public health workforce on emergency management principles, helping to
establish public health emergency operations centers from which
responses are managed, and assisting in the development of plans and
processes that guide response actions. CDC will scale and adapt its
emergency management technical assistance to provide prioritized
support across regions and to countries at their national and sub-
national levels.
Support global and country-level outbreak readiness and response
efforts to address emerging outbreaks and health threats. CDC global
health security efforts, in-country presence, and global leadership are
critical to prevent, detect, and respond to disease threats, including
mpox, Ebola, Marburg, cholera, and more.
Help ensure the efficacy of vaccines for influenza and meningitis,
maintain the primary global resource of respiratory laboratory reagents
for outbreaks, and support global efforts to prevent, detect, and
respond to respiratory disease threats. CDC continuously adapts to an
evolving environment that includes persisting threats of COVID-19,
influenza, respiratory viruses, and changing perspectives on global
pandemic preparedness. Our global approach supports and advances CDC's
global health goals to achieve health impact, health security, and
public health science leadership.
Question. I was disappointed to learn last Friday about the failure
of a promising ALS treatment in its final trials. My heart is heavy for
all of the ALS patients and family members who were holding out hope
for new therapies for this cruel and relentless disease. While we may
be disappointed right now, we cannot let up on efforts to find new
treatments for ALS. And the FDA's support in using its Accelerated
Approval Program to achieve this is more important now than ever.
I have heard from companies across the country, including one in my
home State of Maryland, about exciting therapies with promising results
in clinical trials to address a range of neurodegenerative diseases. As
you know, the Accelerated Approval Program is an important tool to get
innovative treatments to patients facing the most serious health
conditions.
Will you commit to ensuring that the Accelerated Approval Program
remains a viable option for new ALS treatments?
Does your Department believe that any drug that demonstrates the
``clinical benefit'' of ``survival'' in a disease like ALS that is
always fatal (where patients typically live 2 to 5 years after
diagnosis) is by definition reasonably likely to predict an effect on
mortality and should therefore be open for consideration under the
Accelerated Approval Program?
Answer. I recognize the terrible impact of ALS on patients, their
families, and caregivers, and I remain committed in all efforts to
advance ALS drug development. I recognize the continued unmet need for
treatments for patients living with ALS, and I am committed to engaging
with companies and the patient community to facilitate the development
of treatments for this disease. I can also assure you that FDA is
exercising the regulatory flexibility described in FDA's 2019 guidance
for industry titled Amyotrophic Lateral Sclerosis: Developing Drugs for
Treatment (ALS Guidance), and I continue to commit to doing so.
Despite years of research and the availability of some approved
therapies, I know the lack of new treatments for ALS is deeply
frustrating for patients and their families and caregivers. Gaps in
disease characterization, the heterogeneity of the ALS patient
population, and a lack of fit-for-purpose biomarkers, among other
things, all create significant scientific challenges across all
clinical phases of ALS drug development. It is critical that we work
with all stakeholders to further advance the scientific understanding
of ALS, encourage the development of treatments for ALS, support
patient involvement in clinical trials for ALS treatments, and
facilitate patient access to investigational treatments when
appropriate.
FDA and I are committed to facilitating product development for
rare diseases, including ALS. We recognize that certain aspects of drug
development used for common diseases may not be feasible for rare
diseases, including ALS, and that development challenges are often
greater in diseases with very small populations. FDA exercises
regulatory flexibility in these situations to address unique challenges
posed by each disease, such as in trial design, while applying
statutory standards. A higher degree of uncertainty is common in drug
development programs for ALS, where the prevalence of disease, and
consequent limitations on study size, can limit the precision of safety
and efficacy characterizations. We recognize that when a drug is
developed to treat a serious disease for which there are few or no
approved therapies, greater uncertainty or greater risks may be
acceptable for a drug to be approved, provided that the approval
standard has been met. Consequently, FDA often exercises regulatory
flexibility in these cases. It is important to note that this
flexibility applies to rare disease drug development programs that
utilize both the traditional approval pathway and the accelerated
approval pathway. FDA applies flexibility in these situations to
address specific challenges posed by each disease and works with drug
developers to consider the optimal development pathway.
I will note that Qalsody (tofersen) for ALS was approved via the
Accelerated Approval pathway in April 2023. FDA approved Qalsody to
treat individuals with ALS associated with a mutation in the superoxide
dismutase 1 (SOD1) gene (SOD1-ALS). The approval was based on a
reduction in plasma neurofilament light (NfL), a blood-based biomarker
of axonal (nerve) injury and neurodegeneration.
To the question of whether we would consider a drug that has
demonstrated the ``clinical benefit'' of ``survival'' in a disease like
ALS under the accelerated approval pathway, I note accelerated approval
is designed to provide an approval pathway for drugs based on surrogate
endpoints or intermediate clinical endpoints that can be measured
earlier than mortality and are reasonably likely to predict clinical
benefit, such as improved survival. A drug that demonstrates this
benefit may be eligible for traditional approval and would not need to
leverage the accelerated approval pathway. Importantly, we have a
number of programs that can speed the development and approval of
promising drugs regardless of the regulatory approval pathway (i.e.,
traditional versus accelerated approval), including breakthrough
therapy designation, fast track, and priority review. If a drug meets
the criteria for one or more of these expedited programs, we will work
with the sponsor to expedite development of the drug, with the goal of
approving the drug swiftly when evidence supports approval.
______
Questions Submitted by Hon. Bill Cassidy
Question. As I stated in the hearing, I am grateful to the National
Association of ACOs for using VRDC data to find the $2 billion in
Medicare catheter fraud. But I am disappointed this fraud was allowed
to go on for so long and at such a high level without CMS discovering
it.
How does CMS plan to improve their billing auditing to ensure this
cannot happen again?
Does CMS use AI or similar tools to retrospectively review payment
rates and trends?
What is HHS's total budget for technology and data modernization?
Can you please provide a list of technology vendors, contractors,
and subcontractors performing work for HHS along with a list of work
being performed by each broken out by project size, cost, and timeline.
Does CMS require Quality Assurance Surveillance Plans (QASPs) for each
contract?
How does HHS ensure that new technology systems are developed with
a focus on end users, and an eye towards future upgrades? How are those
who develop these systems held accountable for these goals?
Answer. CMS takes Medicare and Medicaid fraud and abuse seriously,
and we are committed to taking swift and aggressive action to identify
and investigate fraud, in support of law enforcement agencies. In early
2023, CMS identified a concerning rise in urinary catheter billings.
CMS identified 11 Durable Medical Equipment (DME) suppliers responsible
for 89 percent of all urinary catheter claims that appeared to be
allowable between January 1, 2023, and March 11, 2024. We quickly
suspended Medicare payments to these suppliers. In most cases, CMS
placed suspensions within days after learning about the billing spikes.
From January 1, 2023, and March 11, 2024, $3.56 billion of catheter
claims made it through most of our payment system checks and were
considered ``payable'' for all suppliers. The 11 top suppliers
represented $3.16 billion of this amount. CMS did not pay $3.16 billion
to the 11 suppliers because we had them on payment suspensions. This
amount would not be reflected on data.cms.gov. In addition, CMS revoked
Medicare enrollments of these suppliers to prevent future improper
billings. Revocations prevent the provider/supplier from reenrolling in
Medicare for up to 10 years.
In general, Medicare regulations allow CMS to suspend payment to a
provider when there is reliable information of an overpayment or when a
credible allegation of fraud exists against a provider. According to
federal Medicare regulations, a credible allegation of fraud is an
allegation from any source, including fraud hotline tips verified by
further evidence, claims data mining, patterns identified through
provider audits, civil false claims cases, and law enforcement
investigations. CMS is required by regulation to consult with law
enforcement prior to suspending payment when we believe there is a
credible allegation of fraud.
When CMS approves a payment suspension, we suspend payment for
allowable claims submitted during the period of payment suspension.
Providers can still submit Medicare payments while under suspension and
these payments may be recorded as Medicare billings, although they have
not actually been paid to a suspended provider. When a payment
suspension is lifted, withheld funds are first applied to any Medicare
overpayment assessed on the provider and second to other CMS or HHS
obligations. If there is no legal financial obligation to another
entity, any excess payments held in suspense are released to the
provider.
Question. I am encouraged to hear you are willing to reconsider the
VRDC transition in order to ensure data access for researchers and
academic institutions. Medicare and Medicaid data are public goods
which we must preserve access to.
Can you please provide additional details on how you intend to make
the system affordable for researchers and students who use this CMS
data, along with an analysis of how many researchers, academic
institutions, and students you believe will be impacted by the change.
Additionally, it is my understanding the VRDC system is currently
very cumbersome to use. Can you please provide a roadmap of how you
intend to streamline and modernize the VRDC system to improve its
utility in the future.
Answer. Due to growing data security concerns and an increase in
data breaches across the health-care ecosystem, CMS is making changes
to the policies around how CMS data is accessed for research. The
agency updates the fees for research data requests periodically to
account for changes in the costs CMS incurs supporting researcher
access to CMS data. Costs associated with maintaining the RIF Data Use
Agreement (DUA), conducting data privacy and security reviews, and
providing Research Data Assistance Center (ResDAC) help desk support
are built into a new Project Fee.
In March, CMS released an updated request for information (RFI)
expanding the solicitation of researcher feedback to include two
additional topics: data access fees and the timing for these changes to
further aid CMS in planning for the implementation of these
changes.\52\ CMS also extended the due date for RFI feedback to May 15,
2024. CMS will be sending out additional guidance later this year and
final guidance prior to requiring researchers to transition their
ongoing research studies to the Chronic Conditions Warehouse Virtual
Research Data Center.
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\52\ https://www.cms.gov/files/document/request-information-
research-data-request/access-policy-changes.pdf.
Question. There is a pressing need to update the CMS 2014 National
Coverage Determination (NCD) for screening of hepatitis C to reflect
the USPSTF 2020 recommendations. The USPSTF covers a broader range of
people who can get the test. In addition, an important update, should
also include testing in non-primary care settings, where a large number
of people of HCV get seen (opioid treatment programs, mobile clinics,
emergency departments, et cetera). There is a precedent for CMS
expanding to non-primary care settings in the CMS 2015 HIV NCD
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Screening for the Human Immunodeficiency Virus (HIV) Infection.
When can CMS get the NCD reupdated to reflect the USPTF 2020
recommendations for screening of Hepatitis C and expand screening to
non-primary care settings?
Answer. Under Sec. 1861(ddd) of the Social Security Act, the CMS
has the authority to add coverage of additional preventive services if
certain statutory requirements are met. Medicare Part B pays for
additional preventive services not described in paragraph (1) or (3) of
the definition of ``preventive services'' under 42 CFR Sec. 410.2, that
identify medical conditions or risk factors for individuals if the
Secretary determines through the national coverage determination
process (as defined in section 1869(f)(1)(B) of the act) that these
services are all of the following: (1) reasonable and necessary for the
prevention or early detection of illness or disability, (2) recommended
with a grade of A or B by the United States Preventive Services Task
Force, and (3) appropriate for individuals entitled to benefits under
Part A or enrolled under Part B.
While CMS has accepted a request to reconsider this NCD, we have
not been able to act on it yet due to our internal capacity restraints.
As CMS indicated in the August 2013 Federal Register notice, ``In the
event that we have a large volume of NCD requests for simultaneous
review, we prioritize these requests based on the magnitude of the
potential impact on the Medicare program and its beneficiaries and
staffing resources.'' 78 Fed. Reg. 48168 (August 7, 2013). This is not
meant to minimize the importance of this request; it only reflects the
limitations of our available resources. This request will be considered
in the future as we prioritize the requests for NCDs.
Question. According to a July 2023 Joint Economic Committee Report,
``Obesity is one of the largest contributors to Medicare and Medicaid
spending.'' Further, the report suggests that in light of such
spending, identifying diseases [in Medicare and Medicaid] ``. . . that
impose the largest financial burden, or which offer the most practical
means of cost reduction . . .'' should be addressed. Obesity and
obesity-related diseases fit both categories. The JEC economists
project that the combined Medicare and Medicaid spending on obesity and
obesity-related diseases will total $4.1 trillion.
What needs to be done to modernize comprehensive obesity care in
Medicare and Medicaid?
Answer. 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.
Currently, 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. The statutory definition of a covered Part D
drug at section 1860D-2(e)(2) of the Social Security Act excludes
certain drugs and medical uses--specifically, those that may be
excluded by Medicaid under section 1927(d)(2) of the Act. This includes
``agents when used for anorexia, weight loss, or weight gain.'' Since
the beginning of the Part D program in 2006, all drugs when used for
weight loss have been excluded from basic coverage. However,
antiobesity medications that receive FDA approval for an additional
medically accepted indication, as defined by section 1927(k)(6) of the
act, can be considered a Part D drug for that specific use.
Medicaid and the Children's Health Insurance Program (CHIP) can
play a role in reducing the rate of obesity in the United States by
improving access to health-care services that support healthy weight.
For eligible children enrolled in Medicaid, the Early and Periodic
Screening, Diagnostic and Treatment (EPSDT) benefit covers all
medically necessary services described in section 1905(a) of the Social
Security Act, which can include obesity-related services. For adults,
the States can choose which services to provide, with most States
choosing to cover at least one obesity treatment.
Question. We've heard concerns from providers that MACs have not
been expediting provider Part B claims, despite not only CMS guidance
but CMS having to go back to the MACs in response to provider
complaints. For example, one MAC posted a notice on their site that
paper claims may take 29 days to process, could not be expedited, and
that each claim had to be accompanied by written documentation
demonstrating the need to file by paper.
What is CMS doing to require MACs to expedite Medicare Part B
claims until Change Healthcare is fully operational and back on line?
Does this outage show that there is a MAC problem in not adhering
to CMS guidance, especially in crisis situations like the current
Change cyberattack?
Answer. Due to the unprecedented impact of the Optum Insight/Change
Healthcare Cyber Incident, CMS is making Change Healthcare/Optum
Payment Disruption CHOPD accelerated or advance payments for a limited
time period to help alleviate financial strain attributed to the
disruption in the claims submission to and payments from Medicare
Administrative Contractors. The CHOPD payment is intended to cover up
to 30 days of Medicare claims and providers/suppliers have 90 days to
repay the payment. MACs are aiming to review requests and will notify
most providers/suppliers of the outcome of their request within 5
business days of receipt.
At the time of this testimony, CMS does not have a projected end
date for the CHOPD accelerated and advance payment program. CMS expects
these payments will no longer be available upon resolution of the
disruptions to Change Healthcare/Optum's Electronic Data Interchange
(EDI). CMS is actively monitoring the Incident and will issue further
guidance if it becomes necessary.
______
Questions Submitted by Hon. Sherrod Brown
Question. I appreciate this administration's continued support to
fund this critical program, which trains the majority of our pediatric
provider workforce.
The President's budget proposes $385 million for CHGME. Robust
funding for this program is what is needed to ensure the longevity of
the pediatric workforce and that children have access to the best care.
Will you continue to work with me and other CHGME champions to make
sure that we continue to grow this essential program for our Nation's
children's hospitals?
Answer. Yes. Thank you for your support of this critical program
for ensuring children have access to the care they need. The FY 2025
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.
Question. As artificial intelligence (AI) technologies continue to
integrate into the health-care system, I am concerned about patient
protections that are in place. The FY 2025 budget includes funding to
oversee HHS's use of AI and mitigate risks, as well as advancing the
responsible use of AI in health care.
Does HHS have a strategy to educate patients on how AI might
utilize their personal health information?
How is HHS ensuring that AI technologies used in health-care
settings does not exacerbate existing disparities?
How is HHS working to ensure AI does not contribute to barriers to
care or denials of services?
What metrics are being considered by HHS to track patient
confidence when engaging with AI technology?
Answer. On October 30, 2023, President Biden issued an executive
order \53\ to help ensure the safe, responsible deployment and use of
AI in the health-care, public-health, and human-services sectors. Among
other items, the EO requires the Secretary of HHS, in consultation with
the Secretary of Defense and the Secretary of Veterans Affairs, to
establish an HHS AI Task Force that shall, within 365 days of its
creation, develop a strategic plan that includes policies and
frameworks--possibly including regulatory action, as appropriate--on
responsible deployment and use of AI and AI-enabled technologies in the
health and human services sector (including research and discovery,
drug and device safety, health-care delivery and financing, and public
health), and identify appropriate guidance and resources to promote
deployment. CMS is actively participating in HHS's efforts and building
our knowledge and capabilities in this space. We are reviewing the
feedback we have received on this issue for potential future
rulemaking. In this way, we are positioning ourselves to respond
agilely to any developments which could negatively impact beneficiaries
of CMS programs and provide guard rails that will enable our programs
to safely reap the benefits of these technological innovations.
---------------------------------------------------------------------------
\53\ Available at https://www.whitehouse.gov/briefing-room/
presidential-actions/2023/10/30/executive-order-on-the-safe-secure-and-
trustworthy-development-and-use-of-artificial-intelligence/.
---------------------------------------------------------------------------
medicaid managed care
CMS is committed to partnering with States to help strengthen the
monitoring and oversight of Medicaid managed care programs. The
increased prevalence of the use of managed care delivery systems over
the past several years underscores the continued need for strong
Federal and State oversight of Medicaid managed care. CMS has taken a
number of steps to support States, including developing a series of
technical assistance tools and toolkits that States are encouraged to
use to improve the monitoring and oversight of their managed care
programs.
The regulations at 42 CFR Sec. 438.210 allow managed care plans to
implement prior authorization processes, so long as certain
requirements are met. Managed care plans must also comply with the
grievance and appeal system requirements laid out in 42 CFR part 438,
subpart F, including the requirement that they can only have one level
of appeal at the plan level before a beneficiary has access to a State
fair hearing under 42 CFR part 431, subpart F. The 2016 Medicaid and
Children's Health Insurance Program (CHIP) Programs; Medicaid Managed
Care, CHIP Delivered in Managed Care, and Revisions Related to Third
Party Liability Final Rule (CMS-2390-F) clarified that States could
offer enrollees the option of an external medical review, as long as
the review is provided at the enrollee's option, is not a requirement,
and is not used as a deterrent to proceeding to the State fair hearing.
Further, if States want to offer enrollees the option of an external
medical review, it must be independent of both the State and managed
care plan and must be offered without any cost to the enrollee. Some
States have utilized this flexibility and chose to offer an external
medical review to enrollees when the managed care plan upheld the
initial prior authorization denial. In addition, CMS, in January,
finalized the CMS Interoperability and Prior Authorization (CMS-0057-F)
rule that requires managed care plans, beginning in 2026, to publicly
report certain metrics about prior authorization, including the percent
of prior authorization requests that were approved, denied, or approved
after appeal. The rule also requires managed care plans to make
detailed information about prior authorization requests and decisions
for items and services (excluding drugs) available to providers
electronically, significantly shortens response times for the managed
care plan to respond to a prior authorization request and requires that
the prior authorization status be made available to enrollees
electronically within one business day. In the case of a prior
authorization denial, the managed care plan must provide a specific
reason for all denied requests.
medicare advantage
An algorithm or software tool can be used to assist MA plans in
making coverage determinations, but it is the responsibility of the MA
organization to ensure that the algorithm or artificial intelligence
complies with all applicable rules for how coverage determinations by
MA organizations are made.
CMS will conduct both routine and focused program audits of
organizations in 2024 to assess compliance with the coverage and
utilization management (UM) requirements finalized in the CY 2024 final
rule. For Medicare Advantage organizations (MAOs) that have routine
program audits scheduled for 2024, these audits will follow our
standard process similar to prior years, covering all applicable
program areas, but will target the new UM requirements during the Part
C Organization Determinations, Appeals, and Grievances (ODAG) review,
as well as the Compliance Program Effectiveness (CPE) review. In
addition, CMS is also adding new focused audits for plans that don't
have routine scheduled audits, which are limited to ODAG and CPE, and
are designed specifically to target compliance with the coverage and UM
policies in the CY 2024 final rule. Through this combination of routine
and focused audits in 2024, CMS expects to evaluate the UM-related
performance of plans serving approximately 88 percent of people with
MA. This expansion of our audit activity will help make sure that MA
beneficiaries get the care they need without excessive burden or delays
and have access to the benefits and services to which they are
entitled. During both the routine and focused program audits, CMS will
utilize physician reviewers to review denied requests to assess whether
MAOs are meeting clinical coverage requirements, such as following
coverage and benefit conditions included in Medicare laws, National
Coverage Determinations (NCD), or Local Coverage Determinations (LCD),
and when permissible, applying internal coverage criteria only when
coverage criteria are not fully established in statute, regulation,
NCDs, and LCDs.
CMS program audits will also ensure that internal coverage criteria
are publicly available and otherwise meet regulatory requirements, MAOs
are only using physicians (or other appropriate health-care
professionals) with appropriate expertise in the field of medicine for
the service at issue when issuing adverse medical necessity decisions,
and MAOs have established UM committees in accordance with regulatory
requirements, including who the members of the committee are and the
responsibilities they are required to complete.
We will be monitoring closely whether MA plans are utilizing and
applying internal coverage criteria that are not found in Medicare
laws, NCDs, or LCDs, and whether the internal coverage criteria are
publicly accessible and coverage policies meet the regulatory
requirements.
CMS has a number of tools it can use to address non-compliance with
the new requirements, including issuing compliance and enforcement
actions. Compliance actions include Notices of Non-Compliance, Warning
Letters, and Requiring Corrective Action Plans.
Question. COVID-19 pandemic-era legislation allowed for the
continuous enrollment in Medicaid for beneficiaries, creating greater
access to health-care coverage. Since these policies expired, over
106,000 Ohio children have lost Medicaid coverage (as of December
2023). I am deeply concerned about these coverage losses and want to
ensure that this process goes smoothly, and that children and families
are not inaccurately being disenrolled from Medicaid.
How is HHS working with States to provide guidance and oversight of
this unwinding process?
What more can be done to help connect Ohio families to care and
ensure children are reenrolled in affordable coverage, as soon as
possible?
Answer. The Biden-Harris administration is committed to using every
available lever to protect and expand coverage for children. As States
undertake Medicaid unwinding, CMS has encouraged them to adopt a range
of options to help ensure that otherwise eligible individuals do not
lose coverage solely for procedural reasons. CMS has been actively
working with States and urging them to adopt all options that we have
offered to help eligible individuals and families maintain their health
coverage during the unwinding process and to work with State partners
to support individuals and families with the renewal process.
As outlined in the March 3, 2022 State Health Official (SHO) letter
#22-001, CMS may approve time-limited authority under section
1902(e)(14)(A) of the Social Security Act to permit States to implement
strategies that are necessary to ensure that States establish income
and eligibility determination systems that protect beneficiaries. CMS
has approved a number of section 1902(e)(14)(A) waivers in relation to
unwinding-related challenges that States face. These include:
Strategies to Increase Ex Parte Renewal Rates; Strategies to Support
Enrollees with Renewal Form Submission or Completion to Reduce
Procedural Terminations; Strategies to Update Contact Information, and
Strategies to Facilitate Reinstatement of Eligible Individuals for
Procedural Reasons. Additional information on section 1902(e)(14)(A)
waivers and other strategies to prevent procedural terminations can be
found here: https://www.medicaid.gov/resources-for-states/coronavirus-
disease-2019-covid-19/unwinding-and-returning-regular-operations-after-
covid-19/covid-19-phe-unwinding-section-1902e14a-waiver-approvals/
index.html.
HHS continues to work to increase access to health-care services
for children. Continuous coverage for children has been shown to reduce
financial barriers to care for low-income families, promote health
equity, and provide States with better tools to hold health plans
accountable for quality care and improved health outcomes. Stable
coverage also enables health-care professionals to develop
relationships with children and their parents, track a child's health
and development, and help a family avoid expensive emergency room
visits. As of January this year, all States across the country are
required to provide children in Medicaid and CHIP with uninterrupted
eligibility over the course of a year. In addition, the budget includes
proposals that would expand continuous eligibility for Medicaid and
CHIP, and HHS is working with States interested in providing multiple
years of continuous coverage, such as up to age 6.
Question. Diagnostic tests are important for timely and effective
health care. Laboratory tests are critical to early diagnosis of
cancer, access to appropriate treatments, and genetic testing.
Unfortunately, Medicare reimbursements to laboratories have not changed
since 2016 and while Congress has continued to prevent devastating cuts
to labs, we need a long-term solution to ensure continued access to
laboratory services, especially those living in rural and underserved
communities. I have bipartisan legislation with Senator Tillis to
update Medicare's payment system for clinical diagnostic laboratory
services to ensure beneficiaries continue to have access to vital lab
services and innovative tests and treatments.
Do you agree that long-term stable payments for laboratory services
is critical to maintaining access to these needed tests, especially in
rural and underserved communities?
Answer. We share your goal of ensuring access to clinical
laboratory services for Medicare beneficiaries. CMS follows the statute
with respect to the Clinical Laboratory Fee Schedule (CLFS). Consistent
with the law, for CYs 2025 through 2027, payment may not be reduced by
more than 15 percent as compared to the amount established for the
preceding year.
Question. The President's budget proposes an increase in funding
for Federally Qualified Health Centers (FQHCs) to support their role in
caring for the most vulnerable in communities across Ohio and the
country.
Do you agree that community health center funding is essential in
increasing access to care? Would you support an increase in funding for
FQHCs in FY 2025?
Answer. Yes. Thank you for recognizing the important work the
Health Center Program plays in ensuring health care to the most
vulnerable communities. In 2022, health centers served more than 30
million patients. The FY 2025 President's budget requests $8.2 billion
for the Health Center Program. The proposed mandatory investments
continue progress on the President's plan to put the Health Center
Program on a pathway to doubling. Health centers provide cost-
effective, high-quality care. The health center model of care has been
shown to reduce the use of costlier providers of care, such as
emergency departments and hospitals. Investing in this program is
essential to maintaining primary care services in underserved and rural
communities.
______
Questions Submitted by Hon. James Lankford
Question. Because the CMS 2022 DIR rule is being implemented
without full transparency and clear ``reasonable and relevant''
reimbursement requirements, pharmacies are currently being hit with a
double whammy. They are still paying retroactive DIR fees from the last
several months of 2023 while also being reimbursed significantly less
on the front end for each prescription filled.
CMS has provided pharmacies facing financial troubles in light of
this DIR transition with an email address to share complaints to CMS
about their treatment from PBMs. Instead of offering appropriate
oversight over PBM actions harming Medicare Part D beneficiaries'
access to pharmacies, pharmacists receive a bounce back email from CMS
telling them that they have no oversight authority nor are they able
``to directly intervene in disputes related to Part D plans'
reimbursement rates.''
Why has CMS offered to receive information about pharmacy financial
struggles if they are not fully willing to provide assistance to
pharmacies?
What is CMS doing with the information submitted to them from
pharmacies about the DIR transition?
Does CMS plan to act to further ensure Medicare beneficiaries'
access to independent pharmacies?
Answer. Section 1860D-11(i) of the Social Security Act generally
prohibits CMS from interfering in negotiations between drug
manufacturers, pharmacies, and prescription drug plan sponsors or from
instituting a price structure for the reimbursement of covered Part D
drugs. Consequently, CMS cannot prohibit PBMs from charging any
retroactive DIR fees.
Nonetheless, we continue to encourage Part D plan sponsors to work
with pharmacies to address cash flow concerns. On November 6, 2023, we
published a memo to all Part D plan sponsors via CMS's Health Plan
Management System (HPMS) titled ``Application of Pharmacy Price
Concessions to the Negotiated Price at the Point of Sale Beginning
January 1, 2024,'' which reiterates and emphasizes several key points
related to this issue that CMS also stated in the Medicare Program;
Contract Year 2023 Policy and Technical Changes to the Medicare
Advantage and Medicare Prescription Drug Benefit Programs final rule.
Within the memo, we strongly encouraged Part D plan sponsors to
consider options such as payment plans or alternate payment
arrangements in advance of the January 1, 2024, effective date. CMS
additionally emphasized that Part D plan sponsors must meet the prompt
payment requirements at Sec. 423.520 and pharmacy access standards at
Sec. 423.120.
More recently, we reiterated these points in our December 14, 2023,
``CMS Letter to Plan Sponsors and Pharmacy Benefit Managers,'' where we
identified several concerns about practices by some plans and PBMs that
threaten the sustainability of pharmacies and impede access to care. We
encouraged plans and PBMs to work with pharmacies to alleviate these
issues and safeguard access to care. To view this letter, please visit
here: https://www.cms.gov/newsroom/fact-sheets/cms-letter-plans-and-
pharmacy-benefit-managers.
CMS uses existing monitoring and enforcement operations to ensure
that Part D plan sponsors comply with the access requirements
prescribed in Sec. 423.120 and prompt payment requirements in
Sec. 423.520. CMS conducts quarterly analyses of all Part D plan
sponsors' networks for the contract year to identify Part D plan
sponsors that are not meeting the pharmacy access standards as required
by Sec. 423.120(a)(1). Part D plan sponsors that do not meet the
standards will receive compliance actions, where the level of the
compliance action escalates when there is repeated noncompliance in
consecutive quarters. CMS monitors the status of Part D sponsors'
complaints from beneficiaries and providers, such as pharmacies. Prompt
payment or pharmacy access violations that come to CMS' attention can
result in a compliance action.
We are committed to ensuring beneficiaries have access to necessary
health services. We value the critical role pharmacies play in health-
care delivery and recognize that we must address the needs of
pharmacies to serve our beneficiaries effectively. We will continue to
engage with stakeholders and consider policies for inclusion in future
rule-making that would lower prescription drug costs for beneficiaries,
address challenges that pharmacies face, and improve the quality of
pharmacy care.
Question. In March 2022, the HHS OIG released a report titled
``Medicare Part D and Beneficiaries Could Realize Significant Spending
Reductions with Increased Biosimilar Use.'' One of the findings of the
report notes that if plans treated biosimilars like they do generics,
beneficiaries could save 22 percent in out-of-pocket costs in a single
year, and Medicare Part D could save nearly one-third in biologic
product spending.
As you know, there are now a number of approved biosimilar products
for the blockbuster drug Humira, most of which offer more than an 85
percent discount to the branded product. However, the branded Humira
biologic maintains a 98-percent market share. Patients are not gaining
cost-saving access to lower-priced biosimilars due to PBM formulary
manipulation.
My bill, the Ensuring Access to Lower-Cost Medications for Seniors
Act, would allow patients to have greater access to and lower cost
sharing for lower priced generics and biosimilars.
How is HHS addressing this issue to ensure that lower cost
alternatives are available on formularies and accessible to patients?
Will you commit to ensuring Medicare beneficiaries are able to gain
access to low-cost biosimilars and generics by continuing to push PBMs
to prioritize patient access and affordability over rebates?
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. CMS
monitors submitted formularies for appropriate inclusion of all drug
classes to ensure Part D sponsors' benefit structures meet statutory
and regulatory requirements for the program. However, under current
law, with some limited exceptions, CMS does not have statutory
authority to require that biosimilar biological products be included on
a Part D sponsor's formulary, placed on a particular tier, or offered
at a particular cost-sharing amount.
CMS's regulatory requirements with respect to formulary changes
take into consideration Part D sponsors' formulary flexibility, out-of-
pocket savings for Part D plan enrollees, and maintaining formulary
stability for Part D plan enrollees throughout a plan year. Part D
sponsors may add biosimilars to their plan formularies at any time as a
formulary enhancement. In a proposed rule issued on November 6, 2023
entitled ``Contract Year (CY) 2025 Policy and Technical Changes to the
Medicare Advantage Plan Program, Medicare Prescription Drug Benefit
Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care
for the Elderly, and Health Information Technology Standards and
Implementation Specifications Proposed Rule'' (CMS-4205-P), CMS
proposed to permit Part D sponsors to treat formulary substitutions of
biosimilar biological products other than interchangeable biological
products for their reference products as ``maintenance changes'' that
would not require prior approval by CMS. Under our current guidance,
plans must obtain explicit approval prior to substituting with
biosimilar biological products other than interchangeable biological
products, and these substitutions apply only to enrollees who begin
therapy after the effective date of the change--delaying enrollees'
access to cheaper options. Treating these substitutions as maintenance
changes would also mean that any substitutions would apply to all
enrollees (including those already taking the reference product prior
to the effective date of the change) following a 30-day notice, so that
enrollee access to equally effective, but potentially more affordable,
options would be available sooner.
Additionally, within the December 2022 proposed rule entitled
``Medicare Program; Contract Year 2024 Policy and Technical Changes to
the Medicare Advantage Program, Medicare Prescription Drug Benefit
Program, Medicare Cost Plan Program, Medicare Parts A, B, C, and D
Overpayment Provisions of the Affordable Care Act and Programs of All-
Inclusive Care for the Elderly; Health Information Technology Standards
and Implementation Specifications'' (CMS-4201-P), CMS proposed to
permit Part D sponsors to immediately substitute: (i) a new
interchangeable biological product for its corresponding reference
product; (ii) a new unbranded biological product for its corresponding
brand name biological product; and (iii) a new authorized generic for
its corresponding brand name equivalent.
HHS will continue to use 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.
Question. In December of 2023, the Senate Finance Committee held a
hearing on drug shortages, during which we heard extensive testimony
indicating that the current prescription drug pricing structure that
incentivizes patient access to high-cost drugs is a driver of many of
the ongoing drug shortages faced by patients in America today. Generic
manufacturers face intense pressure to reduce prices to a point below
the cost of production. As a result, generic prescription drug supply
chains can experience manufacturer exits, low production or stoppages
required by regulators.
What steps is the Department taking to address the issue of drug
shortages and, more specifically, have you contemplated any payment or
contracting changes in Medicare or Medicaid that would address the
precarious economic position of generic drug manufacturers?
Answer. HHS recognizes the severe patient impact from the
persistent problem of chronic drug shortages that have most frequently
impacted inexpensive generic drugs, particularly sterile injectables.
HHS is taking a coordinated approach to help address economic root
causes of shortages.
In November 2023, HHS announced the establishment of a new Supply
Chain Resilience and Shortage Coordinator role responsible for
coordinating efforts across the Department that advance the resilience
of medical product and food supply chains and accelerate the
Department's response to related shortages. Institutionalizing this
coordination across the Department will help HHS meet its long-term
supply chain resilience and shortage mitigation goals. In addition, FDA
on an ongoing basis works to identify shortage risks and determines
actions that can prevent or mitigate patient impact, such as
prioritizing review of manufacturer submissions or working with
manufacturers to increase supply. ASPR also led the development of an
Essential Medicines Supply Chain and Manufacturing Resilience
Assessment to identify supply chain vulnerabilities in a critical
medicines list and has invested, through the Industrial Base Management
and Supply Chain (IBMSC) Office, targeted funds to bolster domestic
manufacturing capabilities for essential medicines.
CMS is also taking steps to help align certain incentives to
bolster supply chain resilience and further promote adoption of
resilient supply chain practices. As discussed in the Calendar Year
2024 Outpatient Prospective Payment System (OPPS) final rule, CMS
solicited public comment on providing separate payment under the
Medicare Inpatient Prospective Payment System (IPPS), and potentially
the OPPS, for establishing and maintaining access to a buffer stock of
essential medicines to foster a more reliable, resilient supply (88 FR
82127-30).
CMS also noted in the CY 2024 OPPS final rule that as part of the
agency's initial efforts, CMS intends to propose new Conditions of
Participation in forthcoming notice and comment rulemaking addressing
hospital processes for pharmaceutical supply (88 FR 82130). CMS
continues to review the comments received to consider ways the Medicare
program can promote hospital resilient supply chain practices to help
mitigate the impact of drug shortages on patients.
HHS looks forward to continuing to work with Congress on future
steps, including potential changes to CMS programs, needed to
comprehensively address economic root causes of shortages.
Question. A recent study published in Psychological Medicine found
that 30 percent of young men who have schizophrenia could have
prevented it by averting cannabis use disorder. Another recent study
published in the Journal of the American Heart Association found that
daily use of cannabis was associated with a 25-percent increased
likelihood of heart attack and a 42-percent increased likelihood of
stroke when compared to non-use of the drug. Marijuana has also been
linked to depression, anxiety, and thoughts of suicide. Another recent
study found that smoking cannabis during pregnancy is linked to lower
birth weight. Both the CDC and NIDA have published that 30 percent of
those who use marijuana have marijuana use disorder.
Was the HHS recommendation to DEA that marijuana be moved from
Schedule I to Schedule III based on new science or public acceptance of
the drug?
Answer. The scheduling review documents reflect HHS's evaluation of
the scientific and medical evidence and its scheduling recommendation
to DOJ.
Question. Why did HHS decide to use a new two-part test to
determine whether marijuana has a currently accepted medical use
instead of the well-established five-part test that was used in the
2016 evaluation of marijuana (that concluded that it had no accepted
medical use).
Answer. The scheduling review documents reflect HHS's evaluation of
the scientific and medical evidence and its scheduling recommendation
to DOJ.
Question. Part 1 of the new test ``considered whether there is
widespread current experience with medical use of marijuana in the
United States by licensed HCPs operating in accordance with implemented
State-authorized programs, where such medical use is recognized by
entities that regulate the practice of medicine under these State
jurisdictions.'' Many of these States legalized medical marijuana
through ballot measures and votes in State legislatures, not through a
scientific and medical process.
Why does HHS consider the popularity of a drug as evidence for its
medical use?
Answer. HHS did not consider popularity of a drug as evidence for
determining if a drug has a ``currently accepted medical use'' under
the Controlled Substances Act (CSA). The scheduling review documents
reflect HHS's evaluation of the scientific and medical evidence and its
scheduling recommendation to DOJ.
Question. Missing Data: HHS agreed to provide us with monthly data
regarding safety and well-being calls for UACs and with monthly data
regarding the Category 2 initiative. This agreement was made in
December 2022 in exchange for Senator Lankford lifting his hold on
Robert Gordon, the nominee for the Assistant Secretary for Financial
Resources at HHS. HHS has failed to provide us with information since
June, and what HHS provided in June was only partially responsive. The
most recent Safety and Well-Being Call data we received was dated
February 2023, and the most recent category 2 sponsor data we received
was labeled November 2022, with the data within the document only going
to September 10, 2022.
Can you advise why we have not received this information? This was
an agreement made in exchange for confirmation. Does HHS not believe
this is an agreement worth abiding by any longer?
When will Congress receive the data requested?
Answer. HHS is committed to working in good faith to address
congressional oversight requests in a timely manner. Already this
Congress, HHS has provided several briefings to both members and their
staff, provided testimony to Congress on several occasions, and
provided thousands of pages of documents detailing how ORR is working
to promote the well-being and safety of unaccompanied children in our
care. We regularly provide briefings to Congress on new developments
and are committed to being responsive to letters that we receive. HHS
looks forward to continuing our productive relationship with Congress--
to ensure that unaccompanied children in our custody receive
appropriate care.
Question. In February 2024, the HHS IG released an analysis of the
sponsor screening and follow-up services HHS provides to UACs. Here is
a summary of the report's findings:
In 16 percent of children's case files, one or more required
sponsor safety checks lacked any documentation indicating that the
checks were conducted.
For 19 percent of children who were released to sponsors with
pending FBI fingerprint or State child abuse and neglect registry
checks, children's case files were never updated with the results.
In 35 percent of children's case files, sponsor-submitted IDs
contained legibility concerns.
ORR failed to conduct mandatory home studies in two cases and four
other cases raise concerns about whether ORR guidance on discretionary
home studies should offer more specificity.
In 5 percent of cases, sponsor records within ORR's case management
system were not updated with child welfare outcomes or sponsorship
history. In 22 percent of cases, ORR did not conduct timely Safety and
Well-Being Follow Up Calls, and in 18 percent of cases, the follow-up
calls were not documented in children's case files.
We know from public sources, like The New York Times, that at least
some, if not the vast majority, of the 16 percent of children whose
case files did not have sponsor safety checks were placed into labor
trafficking situations or sex trafficking situations. What concrete
steps, like changes in policy, has HHS taken to stop this trafficking
and conduct background checks?
We know from these public sources that at least some, if not the
vast majority, of the 19 percent of children who were released to
sponsors with pending FBI fingerprint or State child abuse and neglect
registry checks, children's case files were never updated with the
results. What concrete steps, like changes in policy, has HHS taken to
stop this trafficking and follow-up with sponsors whose pending FBI
fingerprint and State Child Abuse and Neglect registry checks came back
with negative results?
The HHS IG reported that ORR failed to conduct mandatory home
studies in certain cases and that the guidance needed to have more
specificity. Do you agree that HHS's guidance needs to prioritize more
mandatory home studies? If so, when will we see new policies? If not,
why not?
Answer. The HHS Office of the Inspector General (OIG) February 2024
report, reviewed March through April 2021, during one of the most
challenging periods in ORR's history amid a historic number of
unaccompanied children placed in ORR care, the largest and fastest
expansion of emergency capacity, and in the midst of the COVID-19
pandemic. ORR agrees with the report's recommendations, which
correspond with many of the improvements to processes and procedures,
enhanced data systems, and new and updated policies we have put in
place and developed over the last 3 years. These changes simultaneously
prioritize child welfare and safety and minimize the time children
spend in congregate care settings--in line with child welfare best
practices and ORR's legal requirements to release children without
undue delay.
Since April 2021, ORR has made substantial process improvements
based on child-welfare principles to ensure the safety and well-being
of unaccompanied children through comprehensive case management and
enhanced technology, data gathering, and analytics. For instance, ORR
provides 7-day-a-week case management, specifically for family
unification services, and ORR has updated the UC Portal, the UC
Program's data system, to enhance usability and search functionality.
These updates and new features ensure that sponsors' records are
accurately and comprehensively obtained and accessible across the
entire network of care providers. The improvements build in safeguards
and make it easier to identify and flag potential child welfare
concerns during sponsor suitability assessments and aid case managers
in making informed decisions, including regarding home studies.
ORR continuously reviews its vetting policies and procedures for
ways to improve its processes to promote the safety and well-being of
children and to be more efficient and effective. For instance, on June
2, 2023, HHS released the results of its audit of the vetting process
for potential sponsors who have previously sponsored an unaccompanied
child, to ensure all necessary safeguards are in place without
unnecessarily keeping children in government-funded, congregate care
settings. In October 2023, ORR awarded a contract to an outside entity
to conduct future in-depth reviews of random samples of case files by
sponsor category for all children released from ORR care from January
2021-December 2022. The external review is anticipated to be completed
in the summer of 2024. Also, on June 2, 2023, HHS announced additional
efforts to protect the safety and well-being of unaccompanied children,
including a new ORR program and accountability team, now termed the
Integrity and Accountability team, which will further enhance ORR's
work to assess and address potential exploitation risks faced by
unaccompanied children.
Moreover, on February 13, 2024, ORR published policy and procedure
revisions that enhance its sponsor vetting requirements. Among other
enhancements, these revisions require parents and legal guardians
(Category 1) sponsors to provide proof of address documentation
(already a requirement for all other sponsors) and also require, at
minimum, sex offender registry checks for all adult household members
and adult caregivers, including in Category 1 cases. Further, the
revisions require, at minimum, proof of identity and, before the
release of a child, the results of criminal history public records
background checks for all adult household members and adult caregivers,
with a narrow exception for certain Category 1 cases such as where
there are no safety concerns. These recent revisions strengthen and
expand home study policies and guidance to include mandatory home
studies for potential sponsors of more than two children, regardless of
the potential sponsor's relationship to the children.
Question. The VAWA reauthorization in 2013 required ORR facilities
to comply with PREA (Prison Rape Elimination Act) standards for
juvenile facilities. ORR promulgated an IFR to begin implementation of
this requirement in 2014; however, ORR has not taken the steps
necessary to implement this requirement.
An October 2021 investigative report by Senators Grassley and Wyden
found that ORR kept very little data regarding significant incident
reports, which are what ORR uses to classify and monitor sexual assault
and abuse incidents against children in its custody. Their report found
that between 2016 and 2020, nearly 900 allegations of sexual abuse
lodged against staff in its facilities. Based on the IFR above, ORR
should have reached full compliance with PREA standards during this
window.
A 2020 GAO examination had a recommendation that ORR develop a plan
to comply with the IFR and with PREA standards; however, that
recommendation is still listed as ``open.''
Can you share with me whether each ORR facility is now compliant
with PREA standards for juvenile facilities? Has each ORR facility now
completed its initial PREA inspection?
A bipartisan Senate Finance Committee report in October 2021 found
that ORR keeps very little data regarding significant incident reports,
which is how ORR classifies and monitors sexual assault and abuse
against children in its custody. Has ORR updated policy since that
report and, if so, how it has updated its policies? How many SIRs have
been filed regarding sexual assault and abuse in ORR facilities since
2021? How has ORR investigated these reports?
Answer. ORR conducts monitoring to ensure that care provider
facilities meet appropriate standards for the care and timely release
of unaccompanied children and abide by Federal and State laws and
regulations and ORR regulations and policies, including the Interim
Final Rule (IFR), Standards to Prevent, Detect, and Respond to Sexual
Abuse and Sexual Harassment Involving Unaccompanied Children. The
compliance audit process required by the IFR applies to nonemergency
care provider facilities. ORR's secure care provider facilities must
comply with, and are subjected to audit process under the Department of
Justice's (DOJ) National Standards to Prevent, Detect, and Respond to
Prison Rape, 28 CFR part 115 (The Prison Rape Elimination Act). All
other ORR facilities (not including traditional foster homes) must
comply with the HHS Standards to Prevent, Detect, and Respond to Sexual
Abuse and Sexual Harassment Involving Unaccompanied Children, 45 CFR
part 411. This compliance auditing process does not apply to long-term
foster care, secure facilities, and influx care facilities. ORR
monitoring activities include routine site visits, monitoring visits,
and site visits in response to Project Officer (PO), Federal Field
Specialist (FFS), Prevention of Sexual Abuse Team, and other requests.
In compliance with ORR's IFR, in FY 2019, ORR initiated external
audits of care providers. The audit process can typically take up to 9
months to conclude and encompasses a review of care provider files,
staff member personnel records, trainings, and other documentation. The
audit process also includes pre-audit activities, such as reviewing
SIRs that are sexual in nature and having the program complete a pre-
audit questionnaire, and on-site visit. Post-audit activities, include
a report submission to ORR, report review by ORR, submission of a
corrective action plan as applicable to care providers developed in
conjunction with ORR, and final corrective action plan approval.
ORR has a zero-tolerance policy for all forms of sexual misconduct
at all care provider facilities and makes every effort to prevent,
detect, and respond to allegations of such conduct, taking every
incident seriously to ensure every child in care is housed in a safe
environment. In addition to providing required training for staff,
contractors, and volunteers, ORR care provider facilities are required
to provide an orientation to every unaccompanied child on topics
related to preventing, detecting, reporting, and responding to sexual
abuse and harassment. This is in coordination with an on-site
Prevention of Sexual Abuse Coordinator who is able to support children
at all times. Care provider facility staff, volunteers, and contractors
must immediately report allegations to all appropriate investigating
entities in accordance with ORR policy, mandatory reporting laws, State
licensing requirements, and Federal laws and regulations. Since FY
2021, ORR has dedicated significant resources to improve policy and
practices and strengthen collection of data regarding prevention of
sexual abuse incidents such as hiring and reorganizing ORR's Prevention
of Sexual Abuse Team; centralizing reviews, categorization, tracking,
and reporting of Significant Incident Reports; implementing a new data
visualization platform; and implementing new trainings, including in
partnership with HHS OIG's Office of Investigations.
As part of HHS's continuing commitment to assess and improve the UC
Program, since January 2022, ORR has reorganized, recategorized, and
centralized of Significant Incident Reports (SIR) response and
monitoring as part of ORR's effort to better track and trend incident
report information. These improvements allow for more efficient and
effective program oversight so that HHS's ORR and care providers can
focus on incidents that effect immediate child safety and well-being,
thereby strengthening program reporting and response efforts.
The SIR reorganization includes the addition of new categories and
subcategories to improve reporting on incidents that occur in ORR care.
SIR categories and subcategories have nearly doubled to capture a
larger range of relevant incidents that occur in ORR care, and
categories like ``other'' were removed to ensure the most serious
incidents receive appropriate attention based on severity. The overhaul
also streamlined incident notification and escalation through HHS ORR's
new Significant Incident Report Triage Team, as well as referrals to
legal service providers following incidents or disclosures that can
affect a child's immigration case.
Question. As we discussed during the hearing, the Department of
Health and Human Services has cut off access to vital health-care funds
for Oklahoma over political disagreements over Oklahoma's desire to
protect life. This is in direct violation of several laws including the
law that authorizes the grants which prohibits funds from being ``used
in programs where abortion is a method of family planning.'' The same
sentiment is reiterated each year as a condition of title X
appropriations, which states that title X funds ``shall not be expended
for abortions.'' Additionally, the Weldon Amendment, an annual rider
that has been included in every LHHS appropriations bill since 2004,
that prohibits the government from discriminating against entities that
refuse to provide, pay for, provide coverage of, or refer for abortion.
Compliance by the Oklahoma State Department of Health would have
compelled the agency to violate Oklahoma State law. The
administration's radical proabortion policies are disproportionately
impacting rural communities that are already struggling with access to
quality health care.
Oklahoma previously received $4.5 million in title X funds, which
the State typically distributes to local county health departments. It
is my understanding that despite ongoing court cases and administrative
appeals, your agency has rerouted Oklahoma's funding to two entities,
one of which is in Missouri, not Oklahoma. The Missouri Family Health
Council, Inc. received $3.25 million and Community Health Connection
received $216,000, for a total $3.466 million, which is more than $1
million short of the $4.5 million that was supposed to provide health
care for low-
income Oklahomans.
Can you confirm for the record that HHS is denying public health
funds to my State because they refuse to break State law and use
Federal dollars to refer for abortions?
Does this administration prioritize abortion access over the
provision of actual health-care services?
With the rescission of the funds to the Oklahoma State Department
of Health, how does HHS plan to ensure that low-income individuals in
rural communities can still access title X services? The previous award
provided the State with more than $1 million than the additional
grantees received. Further, those grantees are either in urban areas or
in Missouri, and from what I can tell, they do not offer the breadth of
services that OSDH provides. How is this meeting the needs of
Oklahomans?
Is your belief that it would be better for the Oklahoma State
Department of Health not to provide any health services if they refuse
to also provide or refer for abortion, even if low-income and rural
communities are disproportionately impacted?
Answer. In September 2023, HHS awarded nearly $3.5 million to two
title X programs to provide services to residents of Oklahoma, ensuring
that rural and low-income Oklahomans have access to title X services.
Earlier in 2023, HHS notified the previous title X program, the
Oklahoma State Department of Health, that they were out of compliance
with Federal title X regulatory requirements and, therefore, the terms
and conditions of its grant award. The title X program was given an
opportunity to come into compliance but did not, and as a result it no
longer receives title X funding. Oklahoma has since filed suit against
HHS--litigation that is currently underway.
HHS has made great progress in restoring access to title X services
nationwide. In 2022, with new regulations and services restored in all
50 States, Washington, DC, and eight U.S. Territories and Freely
Associated States, the title X family planning network expanded and
increased access to almost 1 million more clients compared to the year
before. In 2022, the number of title X service sites increased by 26
percent and title X providers served 937,490 more family planning
clients in 2022 (a 56-percent increase over the 1.6 million clients
served in 2021).
The Biden-Harris administration is deeply committed to public
health and will continue to champion access to affordable, high-
quality, client-centered health services, including reproductive health
information and care. The $390 million proposed for title X in the FY
2025 budget would expand services to additional clients and additional
communities. We look forward to working with Congress to achieve the
important vision that there are enough title X funds to support quality
family planning, sexual health, and preventive care across our Nation.
Question. An internal workplace guidance document with your
signature on it was brought to my attention regarding transgender
participation in the HHS workforce. The guidance was accompanied by an
unlisted YouTube video announcing the guidance with senior HHS
officials talking about the contents in the leaked guidance I received.
The guidance indicates that refusal to use preferred pronouns could
lead to disciplinary actions, up to and including termination. The
guidance also establishes a policy that anyone can use any bathroom,
locker room, or lactation room that they desire--and no one is allowed
to question their use of those facilities or require proof of any sort
of transition.
Further, if any employees are made uncomfortable by having to share
bathrooms, locker rooms, or lactation rooms with individuals using the
wrong space, they will be directed to use other facilities because,
``employees will not be barred from using the restroom consistent with
their gender identity.'' This raises obvious concerns for the safety
and privacy of women, protection of speech, religious freedom, and
more.
This guidance also makes no attempt to address clear and
longstanding court precedent about compelled speech. There is also no
mention of the obligations placed on HHS by the first amendment, title
VII of the Civil Rights Act, or RFRA.
When my office attempted to schedule a time for you and me to speak
on the phone about these concerns, your office told my team it was not
appropriate for us to connect on it.
Has this guidance or any substantively similar guidance gone into
effect?
Do you intend to issue this guidance or any substantively similar
guidance?
Is it the position of the Department that individuals who persist
in refusing to used preferred pronouns will have their employment
terminated?
What religious and conscience protections do you intend to put in
place?
Has the guidance been modified to ensure it does not violate
existing religious freedom laws and to protect speech and conscience?
Will you commit to working with me to address the serious concerns
I have with the guidance?
Answer. HHS embraces diversity and strives to maintain an inclusive
workplace where all employees have a sense of belonging and can work
effectively to achieve the HHS mission. HHS is committed to an
inclusive environment for all employees, including transgender and
nonbinary employees, to address workplace changes (e.g., changing
official personnel records or staff directories) and to provide
workplace procedures safeguarding gender expression. HHS has begun
implementation of its Gender Identity Non-Discrimination and Inclusion
Guidance (The guidance). The guidance is available on our website:
https://www.hhs.gov/sites/default/files/hhs-gender-identity-non-
discrimination-inclusion-policy.pdf
Question. Do you intend to issue this guidance or any substantively
similar guidance?
Answer. See response above.
Question. Is it the position of the Department that individuals who
persist in refusing to use preferred pronouns will have their
employment terminated?
Answer. HHS believes that all of our employees, including our
transgender and nonbinary employees, must be treated with dignity and
respect when they come to work. To that end, the Department is
committed to providing a workplace free of harassment and where
everyone is safe to come to work.
Question. What religious and conscience protections do you intend
to put in place?
Answer. HHS has preexisting protections for employees based on
their religion. The guidance does not change any of those protections.
Question. Has the guidance been modified to ensure it does not
violate existing religious freedom laws and to protect speech and
conscience?
Answer. See response above.
Question. Will you commit to working with me to address the serious
concerns I have with the guidance?
Answer. HHS is willing to engage with you as HHS works to ensure
that all employees have a safe and productive working environment.
These are important issues, and we are therefore of course willing to
work with all stakeholders on these issues.
Question. Regarding the Change Healthcare February cyberattack, why
did HHS take several weeks before making a public statement after being
made aware of the attack? How does HHS plan to provide immediate
flexibilities to providers, pharmacies, health plans, and State
Medicaid agencies should a similar attack happen in the future?
Answer. CMS recognizes the impact the cyberattack on Change
Healthcare, owned by UnitedHealth Group, has had on providers,
particularly many small providers and those in rural areas. We are
working expeditiously to do our part to ease the impact of the
cyberattack. Specifically, CMS has taken several key actions to support
the provider community during this difficult situation. CMS announced
the availability of accelerated and advance payments for affected
Medicare providers of services and suppliers. Providers and suppliers
should reach out to their Medicare Administrative Contractors for more
information or visit CMS's website for Frequently Asked Questions and
Answers. CMS has also provided flexibility for certain Medicare
reporting deadlines. We encourage Medicare Advantage and Medicare Part
D plans to offer advance funding to providers, and to remove or relax
certain timely filing and prior authorization requirements. We have
provided flexibility for certain Medicare reporting deadlines.
Similarly, we strongly encourage Medicaid and CHIP managed care plans
to remove or relax prior authorization and utilization management
requirements, and to consider offering advance funding to providers, to
the extent permitted by the State.
CMS has maintained frequent communications with UnitedHealthcare
and will continue to press them to communicate with the health care
sector and to offer assistance to providers and suppliers to ensure
continuity of operations for all health care providers and suppliers
impacted by the incident.
______
Questions Submitted by Hon. Michael F. Bennet
Question. In a white paper that I wrote with Senator Cornyn, we
raised the importance of a unified strategy for Federal mental and
behavioral health programs to reduce barriers and cut red tape. We need
a clear strategy on how the Federal programs will collectively advance
our Nation's mental and behavioral health. I know there are a lot of
initiatives within your agency that address a wide array of issues like
youth access, postpartum depression, workforce shortages, and mental
health in schools.
What is the agency doing to coordinate these initiatives to
maximize our resources and make sure that the programs are
complementary to each other?
How do you plan to cut regulatory red tape so that schools,
doctors, counselors, and families can better access these services and
programs?
Answer. Addressing the country's behavioral health crisis is also a
key priority for CMS. Medicaid and the Children's Health Insurance
Program (CHIP) are the largest national payers for behavioral health
services, financing more than a quarter of the country's behavioral
health services. As a part of the agency's Cross Cutting Behavioral
Health initiative, CMS has issued guidance to States on Medicaid and
CHIP coverage and direct reimbursement for interprofessional
consultations, making it easier to integrate behavioral health into a
wider variety of settings and to more effectively involve current
practitioners. CMS released a school-based services guide and fact
sheet, which include guidance on how States can expand access to
Medicaid-covered health services in schools. CMS is also awarding
Medicaid grant awards to States and established a technical assistance
center in coordination with the Department of Education to expand
school-based health coverage and services. CMS has also issued guidance
for States and examples on ways that Medicaid and CHIP payments, 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. This year, CMS has finalized policies related to changes in law
allowing marriage and family therapists and mental health counselors to
enroll in and bill Medicare. Medicare also now pays for clinical
psychologists, licensed clinical social workers, marriage and family
therapists, and mental health counselors to provide behavioral health
integration services in primary care settings.
Question. I appreciate your commitment to make sure that insurance
plans cover mental health visits, including through coordination with
the Departments of Labor and the Treasury to increase enforcement of
mental health parity laws.
Can you outline what gaps in statutory authority for enforcement
may exist, which, if filled, would help address the barriers that
children, adults, and seniors face when trying to access the full
continuum of mental and behavioral health services?
Answer. Nearly a quarter of all adults experienced some form of
mental illness in the last year. The FY 2025 President's budget
strengthens and improves consumer protections by requiring all plans
and issuers, including group health plans, to provide mental health and
substance use disorder benefits in parity with medical and surgical
benefits. The budget seeks to improve compliance with behavioral health
parity standards by requiring plans and issuers to use medical
necessity criteria for behavioral health services that are consistent
with the criteria developed by nonprofit medical specialty
associations, as well as putting medical necessity at the forefront of
care decisions instead of profit. It also authorizes the Secretaries of
HHS, the Department of Labor, and the Department of the Treasury to
regulate behavioral health network adequacy, and to issue regulations
on a standard for parity in reimbursement rates based on the results of
comparative analyses submitted by plans and issuers.
The FY 2025 budget further strengthens consumer protections by
closing various loopholes that have resulted in disparate coverage
practices and providing additional funding for enforcement of mental
health parity requirements. It also makes health care more affordable
by requiring coverage of three behavioral health visits and three
primary care visits without cost sharing. To support equitable
treatment and increased access of covered mental health and substance
use disorder services, the budget also supports a standardized
definition of mental health and substance use disorders, as well as a
permanent expansion of telehealth and other remote care services. In
addition, the budget provides $125 million in mandatory funding over 5
years for grants to States to enforce mental health and substance use
disorder parity requirements. Any funds States do not expend at the end
of 5 fiscal years would remain available to the Secretary to make
additional mental health parity grants.
Additionally, in July 2023, the Departments of HHS, Labor, and the
Treasury proposed a rule that reinforces the Mental Health Parity and
Addiction Equity Act's fundamental goal of ensuring that individuals
have the same access to mental health and substance use disorder
benefits as they do medical and surgical benefits. The proposed rules,
if finalized, would make it easier to get in-network care for mental
health and substance use disorders and eliminate barriers to access
that keep people from getting the care for mental health and substance
use disorders they need, when they need it.
DOL has advised that, with the loss of supplemental funding and
without an increase in the Employee Benefits Security Administration's
(EBSA) base appropriation, the agency faces a precipitous drop in
resources that will require the reduction of its staff from
approximately 850 to 720 and will sustain the loss of about a third of
its enforcement budget by calendar 2025. EBSA is responsible for all
the private employer-sponsored retirement, health, disability, and
other welfare plans in this country, covering approximately 153 million
people and 4.1 million plans. Without additional resources, DOL has
informed us that it will not be able to sustain its MHPAEA and NSA
implementation enforcement efforts without also dramatically reducing
its focus on financial abuse in the retirement context and other
categories of health violations (e.g., fraudulent and mismanaged
Multiple Employer Welfare Arrangements, and systemic claims process
violations, among others).
In addition, the 2022 MHPAEA report to Congress states that EBSA
believes that authority for DOL to assess civil monetary penalties for
parity violations has the potential to greatly strengthen the
protections of MHPAEA. In the absence of the authority to impose civil
monetary penalties, DOL is limited in its ability to ensure appropriate
corrective action in response to findings of noncompliance with MHPAEA.
In 2016, a report issued by the Mental Health and Substance Use
Disorder Parity Task Force concluded that authority to impose civil
monetary penalties for MHPAEA violations, similar to the authority
granted to DOL for enforcement of other laws relating to group health
plans, would lead to more meaningful penalties for noncompliance and
would incentivize compliance.
Question. The number of unaccompanied children arriving at the
southwestern border continues to increase. This strains resources,
which reduces quality of services for these children.
What specific steps is HHS taking to ensure that the
infrastructure, personnel, and other resources are adequately scaled to
manage this surge, especially in terms of providing care and finding
suitable placements for unaccompanied children?
As of 2 weeks ago, 8,800 children are in government care or custody
and the average referral rate is 316 children per day.
How is HHS addressing the challenges related to capacity,
resources, and the overall well-being of these children to ensure they
receive appropriate care?
Given the average length of stay for children in HHS care is 29
days, what strategies or programs is HHS implementing or considering to
reduce this duration?
What strategies or programs are needed to minimize the potential
negative effects on children's well-being and expedite their transition
to more appropriate environments?
Answer. HHS's Office of Refugee Resettlement (ORR) applies child
welfare best practices when placing children in its custody into care
provider facilities, with a preference to place them within ORR's
standard care provider facilities, including State-licensed shelters
and shelters meeting State licensing standards in those States that
refuse to license ORR facilities, group homes, and transitional and
long-term foster care, while sponsorship suitability determinations
proceed and immigration cases are adjudicated. ORR has actively worked
to build its network to ensure that ORR has sufficient standard shelter
capacity that can adapt to the changing needs of the program and that
influx care facilities are used only when needed to ensure ORR can
quickly accept all referrals from Department of Homeland Security (DHS)
in a timely manner.
ORR is focused on initiatives aimed at bringing more standard beds
online, including adding beds to existing grants and funding new
grants. For example, ORR has issued five standing notices of funding
opportunities since December 2021 that will add thousands of additional
standard beds to its network through licensed shelters, group homes,
and/or transitional foster care. ORR continues to prioritize bringing
online State-licensed beds for children placed in ORR care. ORR also
continues to work closely with DHS partners to track migration trends
and patterns and plan ORR capacity needs as far in advance as possible.
This administration inherited a significantly underresourced
Unaccompanied Children (UC) Program with less than half of the needed
shelter capacity in 2021. The prior administration imposed a months-
long hiring freeze on ORR and its grant recipients, severely
restricting the capacity to serve children referred to ORR care and to
address the needs of the UC Program in 2021. In FY 2020, ORR's bed
capacity was insufficient to serve even 8,000 children in care. ORR
continues to enhance its ability to manage emergency response efforts
by expanding standard network bed capacity and minimizing the amount of
time children stay in congregate care settings. As of March 2024, ORR
has updated its infrastructure to have a standard network capacity with
more than 12,000 beds and the ability to activate influx care
facilities more quickly, so that it can care for all children referred
to ORR custody. In addition to drastically expanding its capacity to
serve a historic increase in unaccompanied children, ORR has made
multiple improvements to its case management system. These include
modernizing the UC Portal--the UC Program's data system--with child
safety improvements, such as standardizing addresses and sponsor's
names; making it easier to identify and flag potential child welfare
concerns during sponsor suitability assessments, aid case managers in
making informed decisions regarding home studies; providing 7-day-a-
week case management for family unification services; entering into a
Memoranda of Agreement with the Office of Trafficking in Persons,
National Center for Missing and Exploited Children, and Department of
Labor; and expanding access to post-release services (PRS) to children
released from ORR care from just over 20 percent in FY 2021, to
offering access to PRS to approximately 59 percent of children released
from ORR care in FY 2023.
ORR understands that the best place for a child is in a community
setting and is committed to placing children with vetted sponsors
without undue delay. To reduce the length of stay in ORR's care, ORR--
in collaboration with interagency partners CBP and ICE--launched the
Category 1 and 2 Sponsor Initiatives in August 2022 and May 2022,
respectively. These two initiatives were designed to promote family
unity and to safely streamline sponsor vetting where appropriate to do
so. The Category 1 Sponsor Initiative aims to quickly unify
unaccompanied children with their parent or legal guardian already in
the U.S. The Category 2 Sponsor Initiative (also referred to by DHS as
the Trusted Adult Relative Program) aims to improve processing for
certain Category 2 family groups by allowing for more efficient sponsor
vetting and reunification of children traveling with adult relatives,
who are referred to ORR as unaccompanied.
Question. The budget includes ``antimicrobial subscriptions'' to
encourage the development of innovative antimicrobial drugs--a proposal
that aligns with the bipartisan, bicameral PASTEUR Act that I
introduced with Senator Young.
What are HHS's plans to advance this critical new $9-billion AMR
subscription proposal and realize the goals outlined in the budget?
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. 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 2025 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
the U.S. Department of Health and Human Services (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 of 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.
This proposal complements other HHS and Federal activities under
Goal 4 of the U.S. National Action Plan for Combating Antibiotic-
Resistant Bacteria (CARB), which aims to accelerate basic and applied
research and development for new antibiotics, other therapeutics, and
vaccines. For example, NIH/NIAID is funding and conducting research on
many aspects of AMR, including basic research on how microbes develop
resistance, development of new and faster diagnostics, and clinical
trials designed to find new vaccines and treatments effective against
drug-resistant microbes, and ASPR/BARDA supports the end-to-end
development of products (early research through licensure and
commercialization) and providing capital and technical expertise to
pharmaceutical companies with novel antimicrobial drug candidates.
However, while these ongoing activities are essential to get new
candidates for FDA review, they do not address the market challenges
facing product sponsors after FDA approval. The FY 2025 President's
budget proposal would protect these existing investments by the U.S.
Government by helping to sustain product sponsors and keeping their
products available for patients, while supporting stewardship and
appropriate use.
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.
Question. Patients in Colorado are being harmed by insurers who
refuse to correctly apply the No Surprises Act's clear coverage
protections, including cases where insurers denied coverage for care
related to newborns in NICUs in which the reason for the denial given
by the insurers is that the clinician providing the care was out of
network. Neonatal care provided by an out-of-network clinician at an
in-network facility is explicitly named in the NSA as always subject to
the law's coverage protections; any attempt to deny such care is
unequivocally against the law. Enforcing compliance with the NSA is a
massive undertaking with meaningful opportunities to protect patients
and their access to care.
Does HHS have all of the necessary tools in its toolbox to compel
strict adherence to the law?
Are there opportunities to improve the enforcement mechanisms
within the NSA, especially with these types of insurer violations that
can result in patient harm in mind?
Answer. CMS and States work closely to ensure compliance with the
health insurance accountability and consumer protections in Federal law
including those in the No Surprises Act (NSA). Many States, including
Colorado, have established their own protections against surprise
medical billing before the NSA was enacted. CMS is responsible for
enforcement of provisions of the NSA and Transparency provisions
applicable to providers, facilities, and providers of air ambulance
services in a State, if CMS determines that the State is not
substantially enforcing one or more of the applicable NSA requirements.
CMS operates the No Surprises Help Desk (NSHD) that allows
consumers, and other interested parties to get answers about whether
the NSA applies or to submit a complaint through a webform for
electronic submission or by phone at 1-800-985-3059. After the NSHD
receives a complaint, the complaint is reviewed in its entirety and is
sent to the agency with the appropriate enforcement jurisdiction for
further review. This could be CMS, the Department of Labor, the
Department of the Treasury, or OPM, depending on the details of the
complaint and which agency has jurisdiction over the plan or health
insurance coverage. If the State has enforcement authority, the NSHD
provides the appropriate contact information for that State so that the
State may assist them with their specific situation. CMS is actively
investigating and addressing complaints under our jurisdiction, and if
a violation is found, CMS will not hesitate to enforce the requirement
for payment and will ensure that future payments are made within the
federally required time frame.
Through the CMS investigation process, CMS has directed plans,
issuers, providers, health-care facilities, or providers of air
ambulance services to take remedial and corrective actions to address
instances of non-compliance, which has resulted in approximately
$3,018,432 in monetary relief paid to consumers or providers, as of
October 31, 2023.
Question. There are reports that insurers are refusing to pay or
stalling payments to providers long past the 30-day statutory deadline
after losing in the arbitration process.
Are you aware of long delays in IDR award payments, and what
enforcement activity does HHS have available with respect to these
violations?
I hear from providers that they have no choice but to go to the
dispute resolution process--where I understand they are overwhelmingly
winning--because they are being dramatically underpaid by payers.
What are you doing to ensure payers are paying appropriately up
front?
Answer. The Departments of Health and Human Services, Labor, and
the Treasury (the Departments) understand that the enforcement of the
timeline for non-
prevailing parties to make outstanding payments following a certified
IDR entity's payment determination is an issue and we have received
complaints regarding late payments after a payment determination has
been made. We are actively investigating these complaints and we take
the issue of late payments after IDR payment determinations very
seriously. Additionally, based on our investigations, we have made
operational changes to help mitigate issues we have identified. These
changes include developing a new payment determination template for
certified IDR entities to use which includes claim line-level details
and developing a process for sending these templates through the
Federal IDR portal. While we believe these operational enhancements
should help mitigate some of the identified issues related to missing
information, we continue to investigate complaints as they are
received. In 2022, we provided guidance for certified IDR entities and,
additionally, last fall the Departments proposed a rule to address
specific issues critical to improving the functioning of the Federal
IDR process in response to feedback and challenges noted by interested
parties. In general, the Departments are seeing progress in payers
making timely payments following a payment determination when we reach
out to payers in response to complaints. As we continue to work with
all parties to improve this process, we encourage parties who use the
Federal IDR process and who are not receiving timely payments on closed
determinations to submit complaints.
The Departments have also established a process for parties to an
IDR dispute to submit complaints regarding the other party's non-
compliance with the No Surprises Act's Qualifying Payment Amount
requirements to the No Surprises Help Desk (NSHD). In general, after
the NSHD receives a complaint, the complaint is reviewed in its
entirety and is sent to the agency with the appropriate enforcement
jurisdiction for further review. If the State has enforcement
authority, the NSHD provides the appropriate contact information for
that State so that the State may assist the provider with their
specific situation. The Centers for Medicare and Medicaid Services
(CMS) is actively investigating and addressing complaints under its
jurisdiction, and if a violation is found, CMS will not hesitate to
enforce the requirement.
Question. In August of 2023 HHS recommended to the DEA that
cannabis be reclassified from Schedule I to Schedule III. Since that
transmission we have heard little from your counterparts at the DEA. On
March 9, 2024, a Wall Street Journal article \54\ came out indicating
some internal opposition to the rescheduling process within the DEA.
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\54\ https://www.wsj.com/politics/policy/biden-push-to-ease-
marijuana-restrictions-sparks-tensions-051759f7.
Would you describe your most recent conversations with the DEA and
elaborate as to why HHS has asked the Office of Legal Counsel to weigh
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in on the issue of rescheduling?
What resources does HHS need to help get this process over the
finish line?
Answer. HHS did not request that the Office of Legal Counsel
conduct an analysis of legal issues related to rescheduling marijuana.
As HHS has stated before, the Department concluded its independent
review, guided by the evidence. The scheduling review documents reflect
HHS's evaluation of the scientific and medical evidence and its
scheduling recommendation to DOJ. The scheduling review remains with
DOJ.
Question. Do you feel that your local 988 systems have the capacity
to meet current demand, and does the system overall have adequate
resources to withhold a significant uptick in use as more people learn
about this service, including for
Spanish-speaking populations? If not, where do you lack the resources?
Answer. Since its launch in July 2022, the 988 Suicide and Crisis
Lifeline has received about 9.1 million calls, texts, and chats, with
total overall contacts trending upwards. Despite the increasing volume
of contacts, the average response time across modalities remains below
1 minute and has decreased every year, with the most recent data
showing an answer rate of 91 percent and an average response time of 42
seconds. For Spanish language response thus far in FY 2024, the
Lifeline has received an average of just over 8,000 contacts per month,
with an answer rate of 88 percent and an average response speed under
35 seconds.
The Lifeline's ability and capacity to handle and respond to
increasing volume hinges on its network of national backup centers that
answer contacts when local centers do not have capacity. In FY 2025,
SAMHSA anticipates receiving approximately 7.5 million calls, texts,
and chats to 988. SAMHSA will continue supporting States as they build
local capacity to meet demand; however, if volume significantly exceeds
the FY 2025 projected forecast, it could be challenging for the Network
to maintain current performance levels without additional funding.
______
Questions Submitted by Hon. Steve Daines
Question. Since Day One, the Biden administration's misguided
policies and priorities at the southern border have led to the worst
border crisis in our country's history. Now, rather than take steps to
secure the border, the administration has proposed a rule that would
use taxpayer dollars to fund abortions for minors at the border. Issued
by the Office of Refugee Resettlement, the ``Unaccompanied Children
Program Foundational Rule'' would continue the practice of directing
ORR staff to submit requests to transfer pregnant minors to ORR
facilities in other States in order to circumvent State laws to protect
life while continuing the practice of distributing dangerous chemical
abortion drugs without direct medical supervision to vulnerable
children. Additionally, the proposed rule would now include abortion to
the definition of ``medical services requiring heightened ORR
involvement,'' to prioritize the taking of unborn life rather than
prioritizing the interests of the Unaccompanied Alien Child (UAC).
Does ORR's ``Unaccompanied Children Program Foundational Rule''
conform with the Hyde Amendment's restrictions on HHS funding elective
abortions?
Will ORR's final rule explicitly explain how ORR staff will be able
to avail themselves of protections under Federal conscience protection
laws, such as the Weldon and Coats-Snowe amendments?
Will ORR's final rule explicitly acknowledge protections provided
to employees by title VII of the Civil Rights Act of 1964 and explain
the accommodation request process for employees?
Will ORR's final rule explicitly acknowledge that protections under
the Religious Freedom Restoration Act would apply to individual
employees, as well as organizations and contractors who serve UACs and
object on religious grounds to the taking of unborn life via abortion?
Is ORR considering adding additional medical procedures, such as
gender-
affirming surgery, to the definition of ``medical services requiring
heightened ORR involvement?''
Please provide an estimate and cost analysis on how many abortions
HHS would facilitate under this proposed rule, including whether such
abortions would be chemical or surgical and where such abortions would
take place, as well as each State and locality that HHS would transport
UACs to in order to facilitate abortions.
Please provide a cost analysis for the funding that has been or
would be spent on facilitating abortions for minors including staff
time, transportation, and accommodation costs as a result of this
proposed rule.
Answer. HHS's Office of Refugee Resettlement (ORR) has a moral and
legal obligation to safely and humanely care for all youth referred to
its care and works with its partners across the government to ensure
that children and youth are safe and provided appropriate health care.
HHS complies with Federal law and nothing in the Unaccompanied Children
Program Foundational Rule undermines HHS's compliance with all
applicable laws. In addition, ORR operates the UC Program in compliance
with the requirements of Federal religious freedom and conscience laws.
HHS may make accommodations, including for religious exercise, with
respect to the application of a particular program requirement on a
case-by-case basis in accordance with such laws.
ORR provides accommodations to care providers who maintain a
sincerely held religious objection to abortion. If a care provider has
a religious objection to abortion, and an unaccompanied child in the
care of such a provider is discovered to be pregnant, ORR field staff
will personally deliver any legally required notice to the youth
verbally and in writing, along with other pregnancy-related information
required by ORR policy. Faith-based providers are critical partners for
ORR's mission and to the Unaccompanied Children (UC) Program. ORR
operates in partnership with approximately 95 different faith-based
providers in at least 19 States.
Question. President Biden claims that he supports putting America
first, and that he prioritizes American jobs and American-made
products. The manufacturing capacity for essential medical devices in
the U.S. is at serious risk due to organized efforts by Chinese
manufacturers entering the U.S. market and taking advantage of the
inflationary pressures felt by American manufacturers, distributors,
and providers. This current trend toward purchasing Chinese-made
medical devices is significant and occurring at a pace that will likely
leave U.S. hospitals dependent on Chinese-supplied devices.
During the COVID pandemic, CMS set new payment adjustments to
hospitals for their share of additional cost incurred for domestically
produced N95 respirators. Will CMS take similar action for American-
made essential medical devices and ensure access to these products for
Medicare beneficiaries?
Answer. The COVID-19 pandemic has illustrated how overseas
production shutdowns, foreign export restrictions, and shipping delays
can jeopardize the availability of raw materials and components needed
to make critical public health supplies. CMS is committed to
strengthening the Medicare program using the lessons learned from the
COVID-19 PHE and ensuring beneficiaries have access to the care and
medical devices they need. We look forward to continuing to engage with
the public and Congress on this issue, including potential payment
policies.
Question. One of the hallmark health-care polices of this
administration is the partisan Medicare ``price negotiation'' program,
which effectively sets government-determined prices in Part D. It was
interesting to have seen all 10 of the companies compelled to
participate in this program reject the initial round of government-
proposed prices last week. In the same week, you were quoted saying the
``administration is committed to improving transparency and competition
in health care.'' Government price-setting is the furthest thing from
competition, and it is overly simplistic to think that price setting
will bring down costs. On the contrary, in fact Medicare premiums are
increasing despite the law's attempt to artificially cap them, with the
average premium for a standalone Part D plan rising 21 percent.
Americans want more affordable coverage. What do you have to say
about the expectations that seniors will have to pay higher premiums or
risk losing their drug coverage?
Answer. CMS is committed to ensuring the Medicare Part D program
works for people enrolled in Part D, that benefits remain strong and
stable, and that payments to plans are accurate. Thanks to the
Inflation Reduction Act (IRA), people with Medicare Part D prescription
drug coverage will continue to have improved and more affordable
benefits, including a $35 cost-sharing limit on a month's supply of
each covered insulin product, recommended adult vaccines at no cost,
and additional savings on their Medicare Part D drug coverage costs in
2024. These savings include the expansion of the Low-Income Subsidy
(LIS) program, which helps eligible enrollees afford their premiums and
cost sharing, as well as a cap on out-of-pocket (OOP) costs for
millions of people with very high drug costs in the catastrophic phase
of the Part D benefit. Notably, the IRA additionally provides for Part
D premium stabilization. For CY 2024 through CY 2029, the annual
increase in the base beneficiary premium, which is a component of the
plan-specific basic Part D premiums, is capped at 6 percent.
Last year, CMS announced that the average total monthly premium for
Medicare Part D coverage is projected to be approximately $55.50 in
2024. This expected amount is a decrease of 1.8 percent from $56.49 in
2023. Stable premiums for Medicare Part D prescription drug coverage in
2024 are accompanied by improvements to the Part D program made by the
IRA that allows enrollees to benefit from reduced costs this year.
In CY 2025, the structure of the Part D benefit will be updated to
reflect provisions of the IRA that become effective on January 1, 2025.
The CY 2025 updates include a newly defined standard Part D benefit
design consisting of three phases: annual deductible, initial coverage,
and catastrophic coverage; the lower annual OOP threshold of $2,000;
the sunset of the Coverage Gap Discount Program and establishment of
the Manufacturer Discount Program; and changes to the liability of
enrollees, sponsors, manufacturers, and CMS in the new standard Part D
benefit design.
With regard to Part D premiums for 2025, Part D plans have yet to
submit their bids for the 2025 plan year. The deadline for Part D plans
to submit their bids for the 2025 plan year is June 3, 2024. As a
result, until these bid submissions are received, CMS does not yet have
information on Part D premiums for the 2025 plan year. CMS will be
keeping a close watch on the 2025 Part D premiums.
______
Questions Submitted by Hon. Robert P. Casey, Jr.
Question. The Fiscal Year 2025 President's budget request includes
$150 billion in funding for home and community-based services. An
investment in these services will improve the lives of our loved ones
who need long-term services and supports, their families, and their
caregivers, while filling gaping holes in our care economy. That is why
I was proud to introduce a trio of bills--the Better Care Better Jobs
Act, the HCBS Access Act, and the HCBS Relief Act--to make a
generational investment in home care, enabling older adults and people
with disabilities to receive care in their homes and communities, while
also increasing pay and improving benefits for the caregivers who
provide this life-sustaining care. We have a responsibility to our
communities by investing in excellent HCBS and caregiving economy.
Why is securing the total $150 billion critical to improving and
expanding HCBS for all families?
Answer. The FY 2025 budget proposal to invest $150 billion over 10
years in Medicaid home and community-based services would enable
seniors and people with disabilities (including children) to remain in
their homes and stay active in their communities. At the same time, the
proposal would promote better quality jobs for direct care workers
furnishing HCBS and enhance 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. This investment builds on the short-term HCBS
funding that passed as part of the American Rescue Plan Act of 2021.
Question. The President's Fiscal Year 2025 budget proposes to
provide $492 million for survey and certification activities conducted
by State survey agencies to improve their oversight of nursing homes.
State Survey Agencies are critical to holding nursing homes accountable
in delivering safe and high-quality care. As Chairman of the Senate
Aging Committee, I released a report last year showing how
underinvestment and understaffing at State survey agencies has resulted
in poorer quality of care for nursing home residents. We need to
continue investing in our Nation's nursing homes and in good quality
care for our loved ones.
How would increased investment in survey and certification
activities for State survey agencies improve health and safety for
nursing home residents?
Answer. Despite the tens of billions of federal taxpayer dollars
flowing to nursing homes each year, too many facilities continue to
provide poor, substandard care that leads to avoidable resident harm,
abuse, and neglect. Since 2018, most nursing homes (approximately
13,000) were cited for an infection prevention and control
noncompliance deficiency in 1 or more years. The overall number of
nursing home complaints has sharply increased in recent years, creating
a backlog of more than 30,000 complaint cases as of FY 2023. CMS
expects that States would need to conduct over 90,000 nursing home
complaint surveys in FY 2025, a 13-percent increase over FY 2022.\55\
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\55\ FY 2025 Budget in Brief, https://www.hhs.gov/sites/default/
files/fy-2025-budget-in-brief.pdf.
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 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
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representatives worked on 164,299 resident complaints.
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 complaints against
facilities. Complaint surveys, especially those alleging immediate
jeopardy or actual harm to patient health and safety are the primary
oversight provided, outside of statutory recertification surveys. In
recent years, CMS has established priorities in light of flatlined
budgets to support the inspection of complaint cases, which has limited
the program's capacity to perform standard initial, recertification,
and validation surveys. CMS remains committed to surveying every
Medicare and Medicaid nursing home, every year to ensure these
facilities fulfil their obligations to protect the health and safety of
residents. CMS strongly supports this call for additional survey and
certification activities.
Additionally, flat funding has made it difficult for many States to
offer competitive wages to the health-care personnel who work as
surveyors, leading to surveyor workforce shortages in some areas.\56\
These factors make it challenging for States to complete all
statutorily required nursing home surveys and complaint visits and can
place nursing home residents at increased risk of abuse and neglect.
That is why the FY 2025 Biden-Harris budget proposes to shift funds for
nursing home surveys from a discretionary appropriation to a mandatory
appropriation and increase the funding to a level necessary to achieve
a 100 percent survey frequency, adjusted annually for inflation,
effective in FY 2026. This proposal will guarantee sufficient funding
to promote the health and safety of the Nation's nursing home
residents.
---------------------------------------------------------------------------
\56\ FY 2025 Budget in Brief.
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. As
chair of the Senate Special Committee on Aging, I have used my position
to examine compliance with this law. Following your March 22, 2023,
testimony to the Finance Committee for the FY 2024 budget, I submitted
a series of questions about section 508 at the Department of Health and
Human Services. I appreciate your answers and have follow-up questions
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about the Department's section 508 compliance.
In your 2023 response, you reported that the scanning tools used by
HHS scan about 8 percent of Internet webpages and 0.3 percent of
intranet webpages for accessibility errors. Those numbers are troubling
and unacceptably low, given that HHS websites include critical public
health data and information for key health-care programs. However, I am
pleased that, in your response, you related that the HHS Digital
Accessibility Program was in the process of establishing a new services
contract that was expected to allow for the scanning of all Operating
Division homepages.
Please provide an update on the new services contract for automated
website scanning. Is that contract in place? If so, how long has it
been in place, how long is the contract for, and which company received
the new contract?
Answer. The previous contract expired in December 2023, and the new
contract is expected to be awarded by April 22, 2024. The new contract
is s sole source to Level Access for the Amp Continuum enterprise tool.
This tool has more capabilities then our previous Deque Axe Suite, is
less expensive, and is FedRAMP-certified. The HHS section 508
operations board is scheduling a demonstration for all potential users
tentatively scheduled for April 17th, to begin a transition.
Question. Please detail what percentage of HHS internal websites
and external websites are routinely scanned for accessibility errors as
of March 14, 2024.
Answer. The previous HHS web crawler was not resourced to
centralize the scans of HHS OpDiv websites. Therefore, licenses were
provided but the full list of websites was not able to be aggregated.
Since content is currently federated, there was no central list of HHS
websites available for scanning. Furthermore, internal websites were
not routinely scanned due to configuration challenges.
The HHS Digital Accessibility Program awarded a contract in
September 2023 with a task to ensure all HHS OpDiv homepages are
routinely scanned, and metrics are tracked for accurate reporting.
Under this new task, the program will be better positioned to assist
HHS OpDivs with routine measurement of website conformance. The HHS
program continued to scan websites until December 2023 when the
licenses expired. Scanning will resume when the new tool is
implemented, expected delivery in April 2024.
However, we did routinely scan 19 websites, which included all
OpDiv homepages and department-level websites. For details of the
department-level websites, see the response to the next question.
Question. Although automated website scans are a useful tool, they
do not catch all accessibility errors. The Office of Management and
Budget, on pages 8 to 9 of its December 21, 2023 memorandum on digital
accessibility,\57\ recommended that Federal departments and agencies
pair automated website scanning with manual testing for accessibility
errors.
---------------------------------------------------------------------------
\57\ https://www.whitehouse.gov/wp-content/uploads/2023/12/M-24-08-
Strengthening-Digital-Accessibility-and-the-Management-of-Section-508-
of-the-Rehabilitation-Act.pdf.
Does HHS currently engage in manual testing for website
---------------------------------------------------------------------------
accessibility errors?
Answer. HHS has a federated website environment. So, reporting for
each website's manual testing is not currently provided. However, under
the new HHS Digital Accessibility services contract to be awarded by
April 22, 2024, all OpDiv home pages will be routinely scanned and
accompanied with manual testing. Furthermore, all HHS owned, and
managed websites will be routinely scanned and manually tested. HHS has
conducted several manual tests of high-profile websites such as:
1. The new simplified grants website.
2. Administration of Strategic Preparedness and Response's (ASPR)
Technical Resources, Assistance Center, and Information Exchange
(TRACIE).
3. Youth.gov and engage.youth.gov.
4. Treatments.hhs.gov.
5. Health.gov.
6. Geospatial Health Systems.
7. Opa.hhs.gov.
8. Inflation Reduction Act website.
These websites utilized tools and manual investigation to provide
the site owners with a full accessibility conformance report indicating
defects. After the defects are remediated, another full test will be
conducted to determine the level of conformance.
Question. If so, please describe (a) the process for determining
which HHS websites are subject to manual testing, (b) the number of HHS
websites that were manually tested for accessibility errors from
January 1, 2023, through December 31, 2023, and (c) how many FTEs or
contractors are devoted to manual testing of HHS websites as of March
14, 2024.
Answer. All websites that go through the HHS Office of the
Secretary IT governance process are automatically selected for manual
testing. In addition, all HHS OpDiv homepages will receive automated
scanning and manual inspection on a routine basis to ensure process on
conformance defects. HHS OpDivs maintain the ability to establish their
own processes for HHS OpDiv owned and managed websites.
Due to the federated environment for websites, the HHS OpDivs can
manage their own manual tests and do not currently have a reporting
requirement to provide that data. In addition, our previous web crawler
did not provide an administrative capability to gather this level of
details. However, for HHS OS owned and managed websites, a total of 9
websites (going at least 4 levels down) were manually tested.
HHS Digital Accessibility Programs use a matrixed environment, so
resources are dedicated across all program areas. Furthermore, HHS
OpDivs can resource and manage their digital accessibility risk
assessments as needed. However, the new task for web crawler
administration and scanning calibration awarded in September 2023, for
all HHS OpDiv homepages requires 1,900 contractor resource hours. This
is a blended estimate that includes data analytics and a digital
accessibility subject matter expert. The HHS Digital Accessibility
Program Director monitors and directs the task as part of other duties.
Question. In December, the General Services Administration released
a government-wide analysis of section 508 compliance.\58\ I am pleased
that HHS received a ``high'' section 508 conformance rating on page D-
87 of the analysis. Nevertheless, the analysis also shows that
important work remains to be done on section 508 conformance at HHS.
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\58\ https://assets.section508.gov/files/reports/cr-2023/
FY%2023%20Governmentwide%20
Section%20508%20Assessment%20Report.pdf
One area where HHS could improve is on its section 508 program
maturity. HHS is rated as having a ``moderate'' section 508 program
maturity level. It is also rated as having ``low'' maturity outcomes in
four section 508 program dimensions: (a) communications; (b) human
capital, culture, and leadership; (c) acquisition and procurement; and
---------------------------------------------------------------------------
(d) training.
Please describe the steps that HHS will take to improve maturity in
those areas.
Answer. Communications: The HHS Digital Accessibility Program is
reevaluating and updating the program's communications strategy and
plan. The strategy outlines the mission, vision, communication
objectives, and stakeholders for the HHS Digital Accessibility Program.
The plan provides a more technical approach for achieving the
overarching communication objectives. In addition, the HHS Digital
Accessibility Operations Board is drafting a communication strategy and
plan to establish communication objectives and a plan to achieve those
objectives.
Human Capital, Culture, and Leadership: The HHS Digital
Accessibility Program and the HHS Office of Human Resources (OHR) have
entered a partnership to provide OHR dedicated resources for ensuring
content is conformant. The first initiative was to bring the time and
attendance system (including associated training) into full section 508
conformance. The expected completion data is July 2024. Furthermore,
the HHS Digital Accessibility Program Director is included as a
critical partner in the development of the HHS IT Strategic Plan and
included HHS OpDiv Digital Accessibility program metrics in the annual
portfolio reviews.
Acquisition and Procurement: The HHS Digital Accessibility
Operations Board is reviewing and updating the policy to include
procurement language required in all contracts in which section 508 is
applicable.
Training: The HHS Digital Accessibility Operations Board is
exploring options to make section 508 awareness training mandatory. In
addition, the tools contract referenced above has an optional task to
procure a section 508 learning portal. This portal would provide
extensive training opportunities to all HHS employees. Should funding
become available to execute this optional task, the program stands
ready to increase the learning opportunities for all HHS employees.
Question. Despite the ``high'' section 508 conformance rating at
HHS as a whole, I am troubled that page D-88 of GSA's analysis reports
``low'' section 508 conformance for the Administration for Community
Living. ACL's own mission statement, from its website, is to ``maximize
the independence, well-being, and health of older adults, people with
disabilities across the lifespan, and their families and caregivers.''
That mission makes it particularly important for ACL's electronic
resources to be accessible for people with disabilities.
How will HHS improve section 508 conformance at ACL?
The GSA analysis reported that resources were unavailable to test
ACL's top internal and external webpages, public electronic documents,
and videos.
How will HHS ensure that ACL is able to report on the accessibility
of those electronic resources for GSA's next government-wide section
508 analysis in December 2024?
Answer. HHS is committed to ensuring the accessibility of our
online resources are consistent with Federal laws and regulations,
including section 508 of the Rehabilitation Act. All of HHS is
committed to making our online resources as accessible as possible to
all users, with and without disabilities, and to complying with all
laws and regulations, including section 508 of the Rehabilitation Act.
All materials produced by ACL--including ACL authored reports, budget
requests, and programmatic guidance--meet or exceed section 508's
accessibility requirements, and ACL conforms to the U.S. Access Board's
broader Revised 508 Standards. In addition, ACL requires its
contractors and grantees to produce materials that comply with section
508 requirements, and ACL confirms compliance before posting these
materials on its websites.
Despite ACL's ongoing success in ensuring its materials are
accessible, ACL scored lower in GSA's government-wide section 508
assessment due to the relatively few resources, including staff,
dedicated to the agency's 508 program. For example, ACL's two FTE fall
short of the average number of FTE for an organization at a similar
maturity level (6.05). Similarly, ACL's score reflected a lack of
adequate scanning and testing of its public-facing and internal
Information and Communications Technology (ICT) for compliance.
Historically, ACL relied on the Department for this function, but this
option was not available at the time of GSA's analysis, and ACL lacked
resources to secure these services elsewhere. ACL's score reflected
this change.
ACL is taking critical steps to strengthen its section 508
conformance program. First, ACL is working closely with the HHS 508
program as a member of the HHS Section 508 Operations Board. This
ensures that ACL is engaged in all aspects of 508 and accessibility
policy and planning at the HHS enterprise level. Further, ACL will be
involved in testing and adopting new scanning and reporting tools and
processes for the Department. ACL also will participate in the new HHS
enterprise accessibility program; ACL's internet and intranet sites
will again be included in the HHS enterprise scanning and reporting
processes.
ACL has also backfilled a position with responsibilities for 508
compliance, and with the additional resources received in its FY 2023
appropriation, the agency has strengthened the statement of work for
508 compliance in its new IT services contract. The expected award for
the new contract is late summer 2024. The new contract requires monthly
deliverables specifically focused on 508 conformance and user
experience. In addition, the contractor will use both automated and
manual tools to test both 508 conformance and overall accessibility and
user experience for ACL-managed systems on both computers and mobile
devices, with tests including multiple browser types and versions.
In addition, ACL continues to provide training to staff and works
with contractors and grantees to help them improve their ability to
produce materials that are fully accessible to people with
disabilities.
With these additional steps, ACL is confident that its score will
improve in the next GSA 508 assessment.
Question. The Fiscal Year 2025 President's Budget includes a
request for $10 million for the Countermeasures Injury Compensation
Program. I am pleased to see both the request for additional funding
and the progress that has been made to review more claims and speed up
the pace of reviews, so that eligible claimants can be compensated
faster. One step that would support faster reviews would be publication
of an injury compensation table that identifies injuries associated
with certain covered countermeasures. I understand, based on my staff's
prior conversations with staff at the Health Resources and Services
Administration, that the development of such an injury compensation
table is underway.
Could you please provide an estimate for when this injury
compensation table will be published in the Federal Register?
Answer. As reflected in the Office of Management and Budget Unified
Agenda of Regulatory and Deregulatory Actions, HHS intends to issue a
proposed rule to establish a COVID-19 Countermeasures Injury Table. By
statute, the Secretary ``may only identify such covered injuries, for
purpose of inclusion on the table, where the Secretary determines,
based on compelling, reliable, valid, medical and scientific evidence
that administration or use of the covered countermeasure directly
caused such covered injury,'' 42 U.S.C. Sec. 247d-6e(b)(5)(A). The
proposed table will be published in the Federal Register with an
opportunity for public comment. The number and type of public comments
received will affect the amount of time required to issue a final rule.
If a Countermeasures Injury Table is published or amended and the
effect is that such a new Table or amendment may enable a requester who
previously could not establish a Table injury to do so, the requester
may file a new Request Form within 1 year after the effective date of
the establishment of, or amendment to, the Table, 42 U.S.C. Sec. 247d-
6e(b)(5)(B) (incorporating 42 U.S.C. Sec. 239b(a)(2)). While the COVID-
19 Covered Countermeasures Injury Table is established through the
Federal rulemaking process, requesters should still timely file COVID-
19-related claims, and the CICP will make eligibility determinations as
to whether a covered countermeasure directly caused a serious injury or
death based on compelling, reliable, valid, medical and scientific
evidence (42 U.S.C. 247d-6e(b)(4)).\59\
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\59\ https://www.govinfo.gov/link/uscode/42/247d-6e.
Question. I am grateful for the administration's commitment to
addressing maternal mortality through the additional funding for
research, prevention, and access to perinatal health services. Too many
individuals are dying during pregnancy or in the postpartum period, and
we must do everything that we can to prevent even a single maternal
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death.
Could you elaborate on how the funding in the President's budget
will tackle this public health crisis affecting every community in the
Nation?
Answer. The FY 2025 President's budget includes several investments
to respond to this crisis and improve maternal health outcomes. For
example, the FY 2025 budget dedicates $215 million across HRSA to
support initiatives to address maternal mortality, a $51-million
increase from FY 2024 levels. New investments include growing the
nursing workforce to support maternal care, building an obstetric
safety net in health-care settings that do not offer obstetric care,
including in maternity care deserts, and growing the doula workforce to
provide direct support before, during, and after childbirth. Other
initiatives focus on social determinants of maternal health, including
screening and connection to services, expanding the uptake of
evidence-based models of maternity care, and investment in State data
collection and innovation to improve local response strategies. Lastly,
the budget includes grants aiming to improve access and continuity of
maternal and obstetrics care in rural communities.
______
Questions Submitted by Hon. Todd Young
Question. Last Fall, CMS hosted what it called ``patient listening
sessions'' to gain a patient perspective on the so-called drug
negotiation program in the Inflation Reduction Act (IRA). My
understanding is that CMS held these sessions virtually, did not show
up on camera, and little direction was provided to the patients
presenting their views. Speakers had a maximum of 3 minutes to present,
but there was no time-keeping mechanism available, it was unclear how
the speaker order was determined, and they did not know how CMS
selected the speakers. There was also no way of knowing if more patient
groups registered to share their views than the time allowed.
This lack of transparency and organization means that the true
impacts of the IRA on the patients it was allegedly designed to serve
are still unclear.
What are your plans to improve CMS's process so that patient
concerns with the IRA changes are fully heard and addressed?
Answer. Public feedback has been instrumental in implementing the
Inflation Reduction Act so far, and CMS will continue this engagement
moving forward. CMS received more than 7,500 comment letters in
response to the Medicare Drug Price Negotiation initial guidance,
representing a wide range of views from academic experts and thought
leaders, consumer and patient organizations, data vendors/
software technology entities, health plans, health-care providers,
health systems, individuals, labor unions, pharmaceutical and
biotechnology manufacturers, pharmacies, pharmacy benefit managers
(PBMs), State governments, trade associations, venture capital firms,
and wholesalers.
Additionally, since enactment of the IRA in August 2022, CMS has
engaged with interested parties through various platforms, including
small and large group meetings and written materials and emails via the
IRA mailbox (IRARebateandNego
tiation@cms.hhs.gov). Between September 2022 and June 2023, CMS held
over 140 meetings with interested parties representing the views of
consumer and patient organizations, health-care providers, health
plans, PBMs, pharmaceutical and biotechnology manufacturers,
pharmacies, researchers and academic experts, and wholesalers. CMS also
received 161 written materials before publishing the initial guidance.
CMS leadership participated in 31 speaking engagements on IRA
implementation hosted by interested parties. In addition to meetings
with interested parties on specific issues, CMS has held monthly calls
open to all pharmaceutical and biotechnology manufacturers since
December 2022. During these monthly calls, CMS staff provide an
overview of recent IRA activities and take questions from manufacturer
participants. Finally, in 2023 CMS also held quarterly strategic calls
with trade associations, health plans, pharmacies, and patient groups;
and strategic bi-annual calls with academia/think tanks, and providers/
hospitals.
In the Medicare Drug Price Negotiation Program revised guidance,
CMS outlined additional opportunities for engagement during the
negotiation process. CMS established a web application through which
patients and other interested parties were able to submit data by
October 2, 2023, on each selected drug, such as data on therapeutic
alternatives, and other relevant information. In addition, CMS hosted
meetings with manufacturers of selected drugs in Fall 2023, and CMS
hosted
patient-focused listening sessions for the selected drugs. The patient-
focused listening sessions brought together patients, beneficiaries,
caregivers, and patient/public advocacy organizations as well as other
interested parties to share their patient-
focused feedback with CMS on the selected drugs and their therapeutic
alternatives and other relevant information, such as unmet medical need
and impacts on a wide variety of diverse populations, as CMS develops
initial offers to the manufacturers for each of the selected drugs.
We believe that these sessions were important in helping to inform
CMS as the negotiation process goes forward. On the website for the
patient-focused listening sessions, CMS described the discussion topics
for each selected drug. The sessions were live streamed, so that
patient groups and other stakeholders could listen to the comments
being made by the participants. Information about these patient-
focused opportunities can be found at: https://www.cms.gov/inflation-
reduction-act-and-medicare/medicare-drug-price-negotiation-program-
patient-focused-listening-sessions.
Based on CMS's tracking of meeting agendas and materials provided,
interested parties commonly provided feedback on key Negotiation
Program topics including how to identify qualifying single source drugs
for negotiation, how to apply the orphan drug exclusion to selected
drugs, how to operationalize requests by a biosimilar sponsor to delay
selection and negotiation of a biological product that is a reference
product for biosimilar market entry, and how to effectuate the maximum
fair price (MFP). CMS remains committed to ongoing engagement efforts
with interested parties.
Question. The structure of the IRA drug price negotiations will
change the landscape for the way drugs are developed, especially cancer
drugs. New oncology drugs usually start in smaller populations,
allowing innovators to bring medicines to the market quickly while they
work on application for broader patient populations. The IRA starts the
clock on negotiation with that first approval, which means that
discovery could have a target on its back if it works really well.
How will you make sure that new oncology discoveries are encouraged
and not discouraged by the law you supported?
Answer. CMS supports innovation and believes it is vitally
important that beneficiaries have access to innovative new therapies.
There's a serious issue now with millions of Americans being unable to
afford the drugs that are currently on the market. If patients cannot
afford the drugs they need, they cannot benefit from innovations.
Through negotiations with participating drug manufacturers, CMS is
striving to make drugs more affordable for people with Medicare. The
drug manufacturing industry is strong and thriving. The U.S. market is
the largest in the world--with a track record of fostering innovation.
We pay more for prescription drugs than anywhere else. This will always
be an environment to innovate. We also expect negotiation to encourage
drug makers to create business models to stay competitive, fostering
the development of new treatments and delivery methods.
This FY 2025 Biden-Harris budget builds on the success of the
Inflation Reduction Act by significantly increasing the pace of
negotiation, bringing more drugs into negotiation sooner after they
launch, expanding inflation rebates and the $2,000 out-of-pocket
prescription drug cap beyond Medicare and into the commercial market,
and other steps to build on the Inflation Reduction Act drug
provisions. Expanding the Medicare Drug Price Negotiation Program and
inflation rebates would accelerate the gains in access for Medicare
beneficiaries to innovative, lifesaving treatments enacted in the
Inflation Reduction Act, generating lower costs for people with
Medicare and savings to the Medicare program.
Question. The Inflation Reduction Act implemented a new government
price-
setting policy that includes an excise tax to compel participation by
drug manufacturers. In the statute, the language describes the
applicable tax percentage as between 65 and 95 percent, but tax experts
have clarified that tax liability could be as high as 1,900 percent of
a product's sales price. CMS is responsible for implementing the
program, but has been unclear about how much such a tax penalty could
be if levied.
Please provide an illustrative example of a scenario where a drug
manufacturer has not agreed to the CMS-set price and is out of
compliance for over 270 days. How much tax would they owe on each sale
of a $100-dollar drug? Please consult relevant agencies (e.g., the
Internal Revenue Service) as needed to ensure a complete response.
Answer. A Primary manufacturer may be subject to excise tax
liability under several circumstances, including: (1) the primary
manufacturer decides not to enter into an agreement to participate in
the negotiation program, (2) the primary manufacturer fails to provide
certain required information, or (3) the primary manufacturer does not
agree to a maximum fair price by the statutory deadline. To end a
period of excise tax liability, the primary manufacturer can take the
necessary steps to remedy the reason for the excise tax liability
(enter into an agreement, provide certain required information, or
agree to an MFP), or terminate all its applicable agreements under the
Medicare and Medicaid programs.
The provisions enacted at 26 U.S.C. Sec. 5000D give the primary
manufacturer choices with regard to the negotiation program. The
primary manufacturer may participate in the negotiation program. The
primary manufacturer may opt out of the negotiation program and pay the
excise tax on the sale of the selected drug during defined periods.
Alternatively, the primary manufacturer may opt out of the negotiation
program and avoid the excise tax on sales of the selected drug during
the period for which the manufacturer does not have applicable
agreements with the Medicare and Medicaid programs and none of its
drugs are covered by an agreement under section 1860D14A or section
1860D-14C of the Act.
As described in section 90.1 of the revised guidance, during the
negotiation period, CMS will track and monitor progress during all
steps of the process and engage in direct communications with each
primary manufacturer. To facilitate successful negotiation program
operations and support manufacturer compliance with program
requirements, CMS will issue reminder letters prior to manufacturer
deadlines with warnings of potential applicability of excise taxes,
written notification that a primary manufacturer is in an excise tax
liability period, and written confirmation that a primary manufacturer
has taken the necessary steps to end a period of excise tax liability.
The IRS will administer the excise tax.
Question. The world is facing an antimicrobial resistance crisis.
Superbugs make us all more vulnerable and undermine treatment of
everything from common ear infections to cancer treatments and routine
surgeries. We see more resistant infection now than ever before.
In this budget, President Biden signaled an ongoing commitment to
implementation of a subscription-style incentive program for the
development of novel antimicrobial drugs. That aligns with legislation
that Senator Bennet and I introduced, the PASTEUR Act, which would
create a new payment model for antimicrobials that address an unmet
need. As this issue continues to grow in severity, attention is needed
from HHS to promote policies that will improve stewardship and promote
innovation in drug development.
As Congress deliberates on the policy, what other administrative
actions will the Department be implementing to address the public
health crisis that faces us in antimicrobial resistance?
Answer. HHS cochairs, with USDA and DoD, the Federal interagency
Task Force on Combating Antibiotic-Resistant Bacteria (CARB), which is
charged with working toward the U.S. National Action Strategy for CARB.
The CARB Strategy outlines five goals to combat antimicrobial
resistance (AR) in bacteria and fungi through a One Health approach to
(1) infection prevention and control and antibiotic stewardship; (2)
surveillance; (3) diagnostic testing; (4) antibiotic, antifungal, and
other product development; and (5) global leadership. Since the launch
of CARB in 2015, these coordinated efforts have included more than
doubling the proportion of U.S. acute-care hospitals that have high-
quality antibiotic stewardship programs, from 48 percent in 2015 to 97
percent in 2022;\60\ phasing out the use of medically important
antibiotics for growth promotion in food-producing animals and moving
other uses of these drugs under veterinary oversight; providing support
to move dozens of promising new diagnostics and treatments from the lab
into clinical trials and into health care; and working with global
partners to raise awareness of AR and support best practices across
settings.
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\60\ https://arpsp.cdc.gov/profile/stewardship.
These coordinated efforts contributed to an overall 18-percent
reduction in deaths from resistant infections and a 30-percent
reduction in hospital-acquired resistant infections between 2012 and
2017.\61\ Unfortunately, this work has been complicated by the COVID-19
pandemic, which caused disruptions and delays in actions to combat AR
at the Federal, State, local, and health-care facility levels. CDC saw
sustained high levels of inappropriate antibiotic use in many U.S.
health-care facilities in 2020, as well as higher rates of some
hospital-acquired resistant infections and resulting deaths.\62\
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\61\ https://www.cdc.gov/drugresistance/biggest-threats.html.
\62\ https://www.cdc.gov/drugresistance/covid19.html.
HHS is committed to getting back on course through evidence-based
interventions that reduce the spread and impact of AMR, and that can
also prevent other infections, including COVID-19. These efforts
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include:
HHS is collaborating with EPA and USDA in an interdisciplinary and
One Health effort to improve assessments of potential risks to human
and animal health where the use of certain pesticides could potentially
result in antimicrobial resistance.
FDA is supporting antimicrobial stewardship in veterinary settings
by drafting guidance for industry on a potential approach for defining
durations of use for approved medically important antimicrobial drugs
fed to food-producing animals where none currently exist.
CDC is building health equity into AR efforts by collecting more
comprehensive patient demographic data through the AR Lab Network and
the National Healthcare Safety Network, and by training health-care
workers from diverse backgrounds through Project Firstline. CDC is also
working to enhance public reporting and surveillance of antibiotic and
antifungal use and antimicrobial-resistant infections, through an
upcoming requirement for about 4,500 hospitals in the U.S. to report
information into the National Healthcare Safety Network.\63\
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\63\ https://www.cdc.gov/nhsn/.
CDC and FDA are exploring new developmental and regulatory approval
pathways for novel pharmaceutical agents that can prevent
---------------------------------------------------------------------------
antimicrobial-resistant infections.
NIH continues to support scholars through the Antibiotic Resistance
Leadership Group, which recently published results showing that short
course antibiotic treatment is superior to standard treatment for
community acquired pneumonia in children (< 5 years old) and reduces
the risk of developing bacterial resistance to antibiotics.
BARDA, within ASPR, recently recommitted CARB-X up to $300 million
over the next 10 years. CARB-X has had a huge impact on the
antimicrobial pipeline, with 92 innovative projects in 12 countries,
and 12 of those products have progressed to clinical trials, since its
launch in 2016.
These investments in support for the basic understanding of AR as
well as the discovery, development, and regulatory review of innovative
products, has been critical for addressing the inevitable evolution of
resistance to currently effective treatments. However, these efforts
have not been enough to substantially change the ongoing challenges to
the antimicrobial product development pipeline. President Biden's FY
2025 budget includes a proposal to encourage the development of
innovative antimicrobial drugs by creating a novel payment mechanism
where product sponsors would enter into contracts with HHS that provide
annual payments independent volume of sales. The contracts would help
companies stay solvent and keep products that address critical needs
available, without driving overuse and therefore resistance.
HHS is leading the CARB Task Force in preparations for the UN
General Assembly High-Level Meeting on Antimicrobial Resistance, to be
held in September 2024. This meeting provides a powerful opportunity
for the United States to demonstrate global leadership and express
political commitment to combating AMR and underscore the urgency of
addressing this global threat collaboratively at all levels and across
sectors and regions.
HHS, USDA, and DoD will lead the CARB Task Force in developing a
new National Action Plan for CARB, to be implemented between 2025 and
2030, and which will build on the foundational investments and progress
of the past 10 years.
Question. As you know, I've been working with members of this
committee on an investigation into organ donation and transplantation
and have been advocating for HHS to take meaningful steps to provide
transparency and accountability to the system.
Given HRSA's recent announcements with the Organ Procurement and
Transplantation Network (OPTN) Modernization Initiative, does HRSA plan
to implement any internal policy changes to play a more active role in
OPTN oversight and performance improvement initiatives going forward?
Given expected changes with the OPTN contracts, HRSA will need to
have the capacity and expertise to direct the contractors accordingly,
particularly with the new IT contract. Understanding the funding
requests included in the budget, how is HRSA creating sustainable
staffing expertise and oversight within the agency for this OPTN
contract shift?
Answer. HRSA is taking historic steps as part of its OPTN
Modernization Initiative to improve transparency, performance,
governance, and efficiency of the U.S. transplant system. HRSA has
proactively taken action over the past 2 years to increase oversight
and ensure the security of the OPTN system. This includes conducting
site visits to review the current OPTN IT system management and
processes; conducting penetration tests to identify and correct
potential areas of concern; developing new OPTN security requirements
for all OPTN member transplant programs and organ procurement
organizations; and requiring the OPTN contractor to take corrective
actions on identified security issues.
In addition, HRSA is working to improve oversight of the OPTN and
OPTN contractor, dedicate staffing to increase HRSA's technical and
contractual expertise, and establish a new project management office to
coordinate efforts in this space.
The FY 2025 President's budget request of $67 million would ensure
that resources are available to support all of this critical work. HRSA
will utilize all applicable Federal procurement law, regulation, and
policy to ensure accountability from new vendors, as we do with other
vendors that currently implement IT or other technical functions
through Federal contract for other parts of the agency. HRSA will embed
accountability requirements and performance expectations in the
solicitation process for each OPTN vendor and actively monitor and
evaluate contractor performance. In addition, HRSA is pulling together
a staff with informatics and data expertise, clinicians and organ
experts to strengthen in-house expertise on patient safety and organ
policies, and working with Federal partners to engage the
technologists, project management office roles, and acquisition
managers necessary to oversee a modern, multivendor environment.
HHS is committed to ensuring lifesaving transplantation continues
without disruption as we advance our efforts to create a more
equitable, transparent, and accountable OPTN and higher-performing
transplant system.
Question. Funding for Long COVID research was appropriated by
Congress in December 2020, followed by additional funding directed by
the Biden administration in February 2024. Patient groups and industry
publications have criticized the slow pace of clinical trial design and
enrollment. As of March 2024, only three
RECOVER-sponsored trials have started enrolling patients: RECOVER-VITAL
began enrolling in July 2023; RECOVER-NEURO in September 2023; and
RECOVER-AUTONOMIC in March 2024. The RECOVER trials have estimated
completion dates ranging from the end of 2024 to March 2026. By
comparison, Stanford University's STOP-PASC trial launched in November
2022 and completed in September 2023.
Please explain the multiyear delay between funding being
appropriated to NIH and the clinical trials beginning enrollment?
Please describe the actions being taken to expedite RECOVER
clinical trial enrollment and completion.
Please provide a timeline for when the remaining RECOVER trials,
such as
RECOVER-SLEEP, will begin enrollment.
Answer. The National Institutes of Health (NIH) has launched a
comprehensive research program addressing Long COVID, which represents
a new post-viral disorder which is highly complex and heterogenous,
with over 200 potential symptoms that vary across the lifespan and
demographic groups. NIH is supporting critical basic and clinical
research to understand the fundamental aspects of Long COVID, such as
its clinical spectrum, underlying biology, risk factors, and clinical
sub-phenotypes. This provides the foundation to design scientifically
and medically based clinical trials to determine which interventions to
test, and who to test them in with the goal of generating meaningful
results that would advance treatments for the millions of people
experiencing these disorders. To understand the basics of Long COVID,
NIH has taken a multifaceted and national-scale approach in order to
understand and address the full range of conditions in all patient
groups (adults, pregnant persons, and children) as well as communities
severely impacted by the COVID-19 pandemic. It was critical that NIH
first launch observational and pathobiology studies to identify the
types and frequency of symptoms and their impact on patients' quality
of life; elucidate the root causes and the biologic underpinnings of
these symptoms; and identify biomarkers of disease and potential
therapeutic targets. These studies are already informing diagnosis,
appropriate monitoring and care, and importantly, have already informed
the selection of the initial interventions targeted to specific symptom
clusters and other key aspects of clinical trial design.
Within a year of receiving congressional funding for the study of
Long COVID, NIH designed and implemented the world's most comprehensive
and diverse
patient-centered research program to understand, treat, and prevent
Long COVID. Over the past 2 years, NIH has shared crucial information
about Long COVID from RECOVER that is helping patients by informing
diagnosis, monitoring, and preventive measures. This includes: findings
about the spectrum of clinical symptoms in adults and children; risk
factors for developing Long COVID; impact of viral variants on the risk
for and severity of Long COVID; impact of vaccination on Long COVID;
risk of developing new-onset conditions and/or worsening of preexisting
conditions; and health disparities in Long COVID. Initial results from
the RECOVER adult observational cohort published in the Journal of the
American Medical Association describe clinical sub-phenotypes; provide
a clinical research tool for identifying PASC patients according to the
specific symptom-based criteria; further characterize the impact of
different viral variants and of vaccinations; and define PASC
prevalence in adults. Another 53 scientific papers have been published
or accepted for publication in prestigious peer reviewed journals, 15
are under journal review, and another 80 reports are in preparation.
With a fundamental understanding of certain key aspects of Long
COVID, NIH was able to design and launch evidence-based clinical trials
that focus on the symptoms described as most burdensome by people
experiencing Long COVID. To date, RECOVER has established 5 adaptive
clinical trial platforms, designed 8 clinical trials, opened 4 trials
to enrollment, and planned the launch of an additional 4 trials in the
coming months, resulting in collectively testing 13 active
interventions for Long COVID.
While the current RECOVER trials are Phase 2 clinical
investigations, which typically have a limited number of participants,
these trials are generally more comprehensive than many other clinical
studies. For example, there are key differences in the design of the
Stanford STOP-PASC trial compared to the RECOVER VITAL (Phase 2 trial),
both of which are studying the effects of the antiviral Paxlovid on
Long COVID symptoms. The RECOVER VITAL trial is designed to enroll 900
participants and test two different dosing regimens then following the
participants for 6 months. The Stanford STOP-PASC trial enrolled 168
participants, tested a single dosing regimen, and followed patients for
less than 4 months.
NIH is supporting an array of steps to optimize the design of
RECOVER clinical trials, achieve diversity among trial participants and
meet enrollment targets, and facilitate timely completion of clinical
trials:
Patients participate in the design of clinical trials and
participate on trial governance committees. Their input has
contributed significantly to the selection of interventions and
trial design, which should aid with general patient acceptance
of the trials and willingness to participate in the studies.
Clinical trial sites are selected for their ability to
provide broad and diverse reach, including enrollment in rural
and underserved communities. Sites actively prescreen through
reviews of medical records and medical history to identify
potential participants for inclusion in the trials.
RECOVER clinical trial study teams work to support rapid
site start-up training and completion of mandated regulatory
requirements. This helps to minimize delays in the launch and
implementation of protocols and supports rapid enrollment in
and completion of clinical trials.
Clinical trial sites maintain contact with study
participants, which is critical for retention and adherence to
the interventions tested within each platform trial, as trials
may engage patients for many months either on treatment or for
follow-up.
Patient enrollment for RECOVER-SLEEP is scheduled to begin in
Summer 2024. This study will test interventions for hypersomnolence
(excessive sleepiness during major waking episodes) and for changes in
sleep patterns or ability to sleep after having COVID-19.
Patient enrollment in RECOVER-ENERGIZE is scheduled to begin in
Summer 2024. This protocol focuses on studying exercise intolerance and
fatigue among patients with Long COVID.
Question. Patient groups, experts, and industry publications have
raised concerns around existing Long COVID funding being spent on
observational research. In particular, criticism was directed towards
RECOVER funding being used to duplicate existing findings, instead of
funding trials for treatments or diagnostics.
Will the administration provide assurances that, going forward, the
remaining uncommitted RECOVER funding will be directed primarily
towards trials or novel research directions, and not replicating
existing observational research?
Answer. RECOVER funds have not been and are not being applied to
replicate existing observational research. Long COVID is highly complex
and heterogenous, with over 200 potential symptoms that vary across the
lifespan and demographic groups. RECOVER observational studies are
designed and conducted on a national scale and across the lifespan in
diverse populations. This is essential to generate the necessary
breadth of meaningful results about this heretofore unseen and highly
diverse set of Long COVID conditions, as well as to provide the
necessary robust evidence base for developing diagnostics, safe and
effective treatments, and preventive strategies. While other
observational studies have been conducted outside of RECOVER, they
frequently lacked appropriate controls, were not conducted at a
national scale, lacked the necessary diversity, and did not collect
data in a standardized manner that enables robust conclusions about the
range of heterogeneous conditions associated with Long COVID.
To bolster Long COVID research efforts, HHS invested an additional
$515 million in February 2024, to build on and extend the scope of
RECOVER's work over the next 4 years by:
Testing additional interventions in clinical trials to find
effective treatments to reduce the burden of Long COVID, in
both adults and children;
Increasing our understanding of how SARS-CoV-2 affects each
part of the body as it triggers Long COVID and identifying
potential biomarkers for diagnosis and therapeutic targets for
treatment;
Supporting additional Electronic Health Record (EHR)-based
studies to answer specific questions about the course and
effects of Long COVID and to understand patterns of patient
care as well as clinical practice outcomes;
Supporting critically important follow-up of observational
study and clinical trial participants to assess the long-term
health outcomes of SARS-CoV-2 infection, factors underlying
recovery from Long COVID, and risk factors for long-term
adverse sequelae; and
Maintaining support for secure data management and research
infrastructure to continue the collection, integration,
analysis, storage, and sharing of many diverse types of
clinical data and biospecimens necessary to further understand
the long-term effects of COVID-19 and inform diagnosis,
monitoring, and treatments.
These clinical studies will provide important insights into Long
COVID and will improve our understanding of other infection-associated
chronic conditions with similar symptoms to inform treatments.
Question. Artificial intelligence (AI) in medical imaging has
proven to be an important modernization that is benefiting patients and
will continue to provide valuable innovation in the future. However,
Medicare policy needs to keep pace with appropriate use of AI. In
addition to Congress, a range of Federal agencies are undertaking
important steps to properly address and harness the use of AI and
support continued innovation that benefits patients. Given the
meaningful progress within the medical technology sector, patients,
providers and innovators require updated clarity on CMS's coverage and
reimbursement for AI in medical imaging. Specifically:
What plans are in place for appropriate reimbursement of AI in
medical imaging devices?
Do existing Medicare payment pathways adequately support
innovation, provider adoption, and beneficiary access to health-care
services that are improved with AI?
Has CMS encountered or been made aware of barriers to innovation
for developers and manufacturers of medical imaging devices that
incorporate AI?
Answer. Medicare payment policy is set by Congress, and CMS works
within the confines of the law to establish payment polices. The
Hospital Outpatient Prospective Payment System (OPPS) pass-through and
Inpatient Prospective Payment System (IPPS) New Technology Add-on
Payment (NTAP) collectively incentivize hospitals to quickly adopt and
promote beneficiary access to innovative technologies through
additional payments. Section 1886(d)(5)(K) of the Act requires the
Secretary to establish a mechanism to recognize the costs of new
medical services and technologies under the IPPS. The OPPS transitional
pass-through provisions are established under section 1833(t)(6) of the
Act. The intent of the OPPS transitional device pass-through payment is
to facilitate access for beneficiaries to the advantages of new and
truly innovative devices by allowing for adequate payment for these new
devices while the necessary cost data is collected to incorporate the
costs for these devices into the overall procedure payment rate (66 FR
55861). A criterion for both NTAP and OPPS pass-through is that the
device represents an advance that substantially improves, relative to
technologies previously available, the diagnosis or treatment of
Medicare beneficiaries. In the CY 2020 and FY 2021 annual rulemaking
processes for the OPPS and IPPS, we finalized an alternative pathway
for devices that are granted a Breakthrough Device designation, under
which these devices are not evaluated in terms of the current
substantial clinical improvement criterion for the purposes of
determining device pass-through status or NTAP.
CMS strives to improve patient care and innovation while
maintaining robust safeguards for the Medicare population. As part of
our further efforts to streamline the national coverage process, on
June 22, 2023, CMS announced a proposed procedural notice outlining a
new Medicare coverage pathway, the Transitional Coverage for Emerging
Technologies (TCET) pathway for Breakthrough Devices. This pathway is
intended to offer more timely and predictable access to new medical
technologies for people with Medicare (88 FR 41633). In addition to the
proposed TCET procedural notice, CMS issued an updated proposed
Coverage with Evidence Development (CED) guidance document and a
proposed Evidence Review guidance document. CMS also issued the first
in a series of guidance documents that outline our current thinking on
health outcomes within priority therapeutic areas. These documents
offer insight into how CMS reviews clinical evidence and transparency
regarding CED. We sought comments from stakeholders on the proposed
TCET procedural notice and the proposed guidance documents. We will
respond to comments when we finalize the documents.
______
Question Submitted by Hon. Maggie Hassan
Question. As we have discussed in this committee, hospitals have
been buying physician practices and as a result patients can see prices
double for the same service, at the same location--all because the
hospitals have applied a so-called ``facility fee.'' Patients should
not be paying double what they used to pay for basic health-care
services just because their doctor's office was bought by a hospital.
I have been working across the aisle to end unfair hospital
facility fees in order to bring down health-care costs, save taxpayers
and employers money, and make health care more accessible for more
Americans.
The President's budget proposes to end unfair facility fees for
routine care like office visits, mental health visits, and telehealth
visits.
Can you speak to how this proposal would help patients and families
afford their care?
Answer. As hospitals expand ownership of outpatient and physician
office settings, consumers are seeing an uptick in fees for more than
just the care provided to them. These ``facility fees'' are
increasingly a driver of health-care costs in America and are leading
to consumers being charged as though they received treatment in a
hospital even if they never entered one. This proposal would prohibit
hospitals from billing unwarranted facility fees for telehealth
services and for certain other outpatient services.
______
Questions Submitted by Hon. Thom Tillis
Question. I want to thank you for the Frequently Asked Question CMS
released last month which clarified that critically and chronically ill
Medicare Advantage beneficiaries are entitled to the same access to
Long-Term Care Hospital (LTCH) services as traditional Medicare
beneficiaries. As Senator Murphy and I expressed to you in a letter
last year, Medicare Advantage beneficiaries should have the same access
to LTCH services as traditional Medicare beneficiaries, as required by
law.
Can you describe the enforcement steps HHS/CMS will continue to
take to ensure that bureaucratic red tape will not delay or prevent
care which seniors are entitled to?
Answer. CMS is committed to ensuring that MA enrollees receive
Medicare covered long-term health care. MA organizations must provide
enrollees with access to all medically necessary Medicare Part A and
Part B benefits available under traditional Medicare (with some limited
exceptions), as provided in accordance with section 1852(a)(1) of the
Social Security Act (the Act).
As part of the CY 2024 Policy and Technical Changes to the Medicare
Advantage and Medicare Prescription Drug Benefit Programs Final Rule
(88 FR 22120), CMS clarified existing requirements and established new
requirements affecting MA organizations' coverage criteria and the
relation of such criteria to traditional Medicare coverage policies. We
clarified the existing requirements that MA organizations must comply
with National Coverage Determinations, Local Coverage Determinations,
and general coverage and benefit conditions included in traditional
Medicare statutes and regulations. CMS also established that when
applicable Medicare coverage criteria are not fully established, MA
organizations may create internal coverage criteria based on current
evidence in widely used treatment guidelines or clinical literature
made publicly available, consistent with Sec. 422.101(b)(6). The CY
2024 final rule also finalized additional enrollee protection
requirements to improve continuity of care and integration of health-
care services and to increase MA organizations' compliance with regard
to UM policies.
Furthermore, CMS regulations at Sec. 422.101(b)(2) state that MA
organizations must comply with coverage and benefit conditions included
in traditional Medicare laws, which includes payment criteria for
inpatient admissions at Sec. 412.3. As described in the February 6,
2024, memorandum ``Frequently Asked Questions Related to Coverage
Criteria and Utilization Management Requirements in CMS Final Rule
(CMS-4201-F),'' if a patient is being discharged from an acute-care
hospital to a post-acute-care facility that would be covered under
traditional Medicare and the patient's attending physician orders post-
acute care in the specific type of facility (i.e., Skilled Nursing
Facility (SNF), Long-Term Care Hospital (LTCH)) and the patient meets
all applicable Medicare coverage criteria for admission into that
facility type, the MA organization cannot deny admission to that post-
acute setting and/or redirect the care to a different setting.
Regarding enforcement of regulatory requirements, CMS has a well-
established, robust, and successful process for ensuring organizations
that offer MA and prescription drug plans are complying with applicable
requirements. When an MA plan is not in compliance, CMS may require the
plan to correct the non-compliance by submitting and completing a
corrective action plan (CAP), hiring an independent auditor to test the
corrections, and successfully completing a validation audit that
demonstrates correction of the issues identified in the CAP. CMS can
issue an enforcement action when an MA plan is noncompliant with
existing program requirements. This could also include situations where
an MA plan improperly denies a service, including when a denial is
based on UM criteria that does not comply with CMS's requirements, or
the MA plan is out of compliance with either approving or covering
required items and services.
Question. In the proposed rule on compensation rates, CMS said that
the agency lacks the data to quantify the impact the proposed changes
will have on the more than 30 million beneficiaries enrolled in
Medicare Advantage. The information that CMS relied on to draft the
proposed changes has not been publicly released for review.
Will CMS publish for public comment the sources that CMS relied on
prior to making a final determination on the Medicare Advantage broker
compensation proposal?
Answer. We agree that it is critical to ensure that as the MA
program continues to grow, it remains viable and that seniors and
individuals with disabilities eligible for Medicare can make informed
decisions about their health-care coverage, and, when appropriate,
enroll in the plan that is best suited to their personal health-care
needs. As discussed in the CY 2025 MA and Part D proposed rule, section
1851(j) of the Social Security Act requires that CMS develop guidelines
to ensure that the use of compensation creates incentives for agents
and brokers to enroll individuals in the MA plan that is intended to
best meet their health-care needs. We have learned, however, that many
MA and stand-alone prescription drug plans (PDP), as well as third-
party entities with which they contract (such as field marketing
organizations (FMO)), have structured payments to agents and brokers
that have the effect of circumventing existing CMS regulations that
limit agent and broker compensation to specified fair market value
(FMV) levels. CMS has also received complaints from different
organizations, including State partners, beneficiary advocacy
organizations, and MA plans to this effect. A common thread to the
complaints is that agents and brokers are being paid, typically through
various purported administrative and other add-on payments, amounts
that cumulatively exceed the maximum compensation allowed under the
current regulations. Moreover, CMS has observed that such payments have
created an environment, not dissimilar to what originally prompted us
to set limits on agent and broker compensation in 2008, where the
amounts being paid for activities that do not fall under the umbrella
of ``compensation,'' are rapidly increasing.
We understand that FMOs help millions of Medicare beneficiaries to
learn about and enroll in Medicare, Medigap, MA plans, and PDP plans by
providing guidance on plan options, including comparisons of relative
costs and coverage, as well as assisting beneficiaries with applying
for financial assistance.
In our proposed rule, CMS is focused on current payment structures
among MA organizations, agents, brokers, and third-party marketing
organizations (TMPO), including FMOs, that may incentivize agents or
brokers to emphasize or prioritize one plan over another, irrespective
of the beneficiary's needs, leading to enrollment in a plan that does
not best fit the beneficiary's needs and a distortion of the
competitive process. In this rule, CMS has proposed to: (1) generally
prohibit contract terms between MA organizations and agents, brokers,
or other TMPOs that may interfere with the agent's or broker's ability
to objectively assess and recommend the plan which best fits a
beneficiary's health-care needs; (2) set a single agent and broker
compensation rate for all plans, while revising the scope of what is
considered ``compensation;'' and (3) eliminate the regulatory framework
which currently allows for separate payment to agents and brokers for
administrative services. The public comments received on the CY 2025 MA
and Part D proposed rule, including those received on the proposals
related to agent and broker compensation, are available for public
reviewing on Regulations.gov.
Question. According to the Health and Human Services Office of the
Inspector General, more than 50,000 Medicare Part D beneficiaries
experienced an opioid overdose in 2021.
When it comes to treating acute pain with nonopioid alternatives,
what direction are you giving as HHS agencies to ensure that patients
will have access and incentives to move to alternative nonopioid
medicines once approved by the FDA?
Has HHS analyzed factors that might steer patients towards lower-
risk acute pain management options, such as nonopioid alternatives, and
the potential effects of successful steering along these lines?
Do you believe that cost sharing requirements could be a
disincentive and even a burden for patients who may benefit from
nonopioid alternatives?
Answer. Substance use disorders (SUD) impact the lives of millions
of Americans, including individuals who are enrolled in the Medicare
program. CMS is committed to ensuring that Medicare beneficiaries who
have an opioid use disorder (OUD) have access to appropriate treatment,
including medications for opioid use disorder (MOUD). Ensuring access
to these benefits and addressing equity concerns is an important part
of combating the Nation's opioid epidemic, and CMS has been actively
engaged in the work necessary to meet these goals.
CMS is pleased to note that the OIG report entitled, ``The
Consistently Low Percentage of Medicare Enrollees Receiving Medication
to Treat Their Opioid Use Disorder Remains a Concern, OEI-02-23-00250''
found a 36-percent increase in the number of enrollees receiving
naloxone through Medicare from 2021 to 2022 and found that indicators
of misuse and diversion of prescription opioids in Part D continued to
decline. However, CMS also recognizes there is more work to do in
increasing access to OUD treatment and addressing health equity.
Several recent changes have expanded Medicare beneficiaries' access
to MOUD. First, on January 1, 2020, Medicare began paying Medicare-
enrolled Opioid Treatment Programs (OTPs) with a bundled payment to
deliver OUD treatment services to Medicare beneficiaries as required by
the Substance Use Disorder Prevention that Promotes Opioid Recovery and
Treatment for Patients and Communities (SUPPORT) Act. Medicare
Advantage plans must also include the Medicare OTP benefit and can
contract with OTP providers in their service area, or agree to pay an
OTP on a non-contract basis. To further promote continuity of care, in
addition to on-site treatment, OTPs may also provide beneficiaries with
unsupervised take-home doses of medication in accordance with certain
time in treatment standards.
Second, effective December 29, 2022, providers with a current Drug
Enforcement Administration (DEA) registration no longer need the DATA-
Waiver (X-Waiver) from the Substance Abuse and Mental Health Services
Administration (SAMHSA) to prescribe buprenorphine, a type of MOUD,
strengthening Medicare providers' ability to care for beneficiaries
with OUDs.
Finally, in March 2023, the Food and Drug Administration (FDA)
announced that Narcan, a brand-name formulation of the opioid overdose
reversal drug naloxone, would be available without a prescription.
While Medicare Part D generally does not cover over-the-counter
medications, this change will remove barriers to access by allowing
beneficiaries to purchase the medication without first meeting with a
provider. Other options for Medicare-covered naloxone will remain
available, such as other formulations or dosages of naloxone that
remain prescription drugs, as well as other overdose reversal
medications.
CMS will continue to monitor use of, and access to, these
medications. CMS monitors prescription drug use in Part D (including
over-utilization and/or under-utilization of opioids, buprenorphine,
and MOUD) through prescription drug event (PDE) data to oversee
sponsors' compliance with drug utilization review (DUR) requirements as
described in 42 CFR Sec. 423.153. CMS also monitors complaints in the
Complaints Tracking Module (CTM) in the Health Plan Management System
to identify potential access issues. CMS may follow up with Part D plan
sponsors that are outliers, or share information with Departmental
partners, as appropriate.
Combating the opioid epidemic is a top priority for CMS, and CMS
remains committed to ongoing examination of its payment and coverage
policies to ensure health-care providers are enabled to execute best
practices with respect to pain management and treatment of OUDs.
CMS continues to support opioid alternatives offered by traditional
Medicare, MA plans, and Part D plans, including the coverage of
acupuncture to address lower back pain and educating providers on other
non-opioid alternatives.
Question. You know how important a diagnostic test is for timely
and effective health care. During COVID, we saw how critical access to
diagnostic tests were and how quickly our laboratories stepped up to
the plate for public health. But it's not just COVID when testing is
needed, tests are critical to early diagnosis of cancer, patients
finding the right treatment for their disease, and couples trying to
start a family who need to know their genetics. Unfortunately,
reimbursements to laboratories have not changed since 2016 and while
Congress has prevented damaging cuts to labs annually, we need a long-
term solution to ensure continued access to laboratory services for
Americans, especially those living in rural and underserved
communities.
Do you agree that long-term stable payments for labs is critical to
maintain access to laboratory services, especially in rural and
underserved communities across this country?
Answer. We share your goal of ensuring access to clinical
laboratory services for Medicare beneficiaries. CMS follows the statute
with respect to the Clinical Laboratory Fee Schedule (CLFS). Consistent
with the law, for CYs 2025 through 2027, payment may not be reduced by
more than 15 percent as compared to the amount established for the
preceding year.
Question. I want to bring to your attention to an important
initiative at the Department called the National Correct Coding
Initiative (NCCI). It is an important program working to reduce fraud
and abuse in the Medicare billing system. However, it is not always a
transparent and collaborative process for stakeholders, which can lead
to decisions that would restrict access to necessary decision-making
tools for providers and patients. For example, last year, the NCCI
proposed a coding policy edit critical to testing for substance use
disorders. They made this decision without appropriately consulting
relevant stakeholders and contradicting the American Medical
Association (AMA) coding guidelines.
We are working to require more transparency in the NCCI program
through legislation. Can you commit to assisting us in increasing
transparency in the NCCI program?
What steps are you taking to proactively ensure that patients have
access to drugs in the 6PC considering significant forthcoming changes
to Part D plan benefit design?
Do you have the internal data and analysis systems to accurately
evaluate access before and after implementation? Can you provide a list
of all initiatives and the major actions taken or planned for each,
including any improvements to data collection?
Answer. CMS's mission for program integrity is to prevent, detect,
and combat fraud, waste, and abuse across its programs. CMS works with
providers, plan sponsors, States, and other stakeholders to support
proper provider enrollment and accurate billing practices. NCCI
promotes national correct coding methodologies and reduces improper
coding that may result in inappropriate payments in Medicare Part B
claims. The coding decisions for these edits are based on coding
conventions defined in the American Medical Association's Current
Procedural Terminology (CPT) Manual, Medicare policies, coding
guidelines developed by national societies, and the coding decisions
for these edits are based on coding conventions defined in the American
Medical Association's Current Procedural Terminology (CPT) Manual,
Medicare policies, coding guidelines developed by national societies,
and standards of medical and surgical practice. NCCI edit tables are
refined and updated quarterly to address changes in coding guidelines
and additions, deletions, and modifications of Healthcare Common
Procedural Coding System (HCPCS)/CPT codes.
Question. The Institution for Mental Diseases (IMD) exclusion
prohibits Medicaid funding for residential behavioral health treatment
with more than 16 beds. This rule has been applied to Qualified
Residential Treatment Programs (QRTPs), a
trauma-informed placement for foster youth with assessed need, a CMS
decision which has helped create the youth behavioral health bed
shortage and workforce crisis we're in today.
Can you explain how youth placed in QRTPs with 17 beds fare worse
than those in QRTPs with 15 beds?
The Biden administration has made clear that time-limited
residential placements for children with assessed need should be phased
out, despite the fact that Congress enshrined these settings in the
Family First Prevention Services Act just 6 years ago. In your FY25
budget, you call for even further reductions in reimbursement rates for
QRTPs--which would limit States' ability to provide qualified,
accredited, and therapeutic care for foster youth with behavioral
health needs.
Can you speak to where children should be placed instead of QRTPs,
particularly if they have been unsuccessfully and disruptively shuffled
between multiple foster family homes already?
Answer. Strengthening behavioral health care is a top priority for
the Biden-
Harris administration. CMS has worked within the confines of the law to
provide States with flexibility to increase access to services for
certain individuals residing in institutions for mental disease (IMDs),
including foster youth in Qualified Residential Treatment Programs
(QRTPs) that are IMDs. CMS has approved Medicaid section 1115
demonstrations that allow State Medicaid programs to pay for services
provided to certain individuals in QRTPs that are IMDs. Similarly,
managed care plans are permitted to pay for up to 15 days per month of
treatment in QRTPs that are IMDs as an in-lieu of service--that is, a
service that is not included under the State plan, but is a clinically
appropriate, cost-effective substitution for a similar covered service.
Children in foster care should receive the medical care that they
need and to which they are entitled, without disruption, in a safe and
nurturing setting that fosters their growth and development. CMS is
committed to ensuring children with unique health needs receive high-
quality care in the most appropriate setting permissible under the law,
and CMS has worked within the confines of the law to provide States
with flexibility to increase access to these services.
The FY 2025 budget proposes a set of comprehensive child welfare
proposals that, combined, seeks to reduce the number of children
entering foster care and, for those children who do need to enter care,
expands the provision of kinship placements and discourages the use of
congregate care. The budget seeks to align Federal financing with child
welfare best practices and research that shows that most children do
best with kin or in another foster family home and experience worse
outcomes when in a group setting.
Question. With the Inflation Reduction Act's changes to Part D set
to take effect in 2025, I am concerned that Part D plans will be
incentivized to more broadly apply utilization management tools such as
step therapy in ways that could restrict and delay seniors' access to
care. It is important that the Centers for Medicare and Medicaid
Services (CMS) get ahead of this issue before seniors are harmed.
What action is CMS taking now to protect seniors from adverse
impacts, including by ensuring greater transparency of plans'
utilization management policies? Will you ensure that adequate
protections for beneficiaries are in place before 2025?
Answer. CMS is continuing to work to improve the Medicare Advantage
and Part D prescription drug programs and maintain high-quality health-
care coverage choices for all Medicare enrollees.
CMS maintains, and will continue to maintain, a robust clinical
formulary review process to ensure that all Medicare Part D plans meet
applicable formulary requirements. Consistent with the requirements at
Sec. Sec. 423.120(b)(2) and 423.272(b)(2)(i), CMS evaluates formularies
based on the sufficiency of categories and classes, tier placement, and
utilization management restrictions. This review process is based in
part on section 1860D-11(e)(2)(D)(i) of the Social Security Act, which
authorizes CMS to approve a prescription drug plan only if the agency
``does not find that the design of the plan and its benefits (including
any formulary and tiered formulary structure) are likely to
substantially discourage enrollment by certain Part D eligible
individuals under the plan.'' In addition, under Sec. 423.272(b)(2)(i),
``CMS does not approve a bid if it finds that the design of the plan
and its benefits (including any formulary and tiered formulary
structure) or its utilization management program are likely to
substantially discourage enrollment by certain Part D eligible
individuals under the plan.'' Furthermore, Sec. 423.120(b)(2)(iii)
requires each Part D plan formulary to ``include adequate coverage of
the types of drugs most commonly needed by Part D enrollees, as
recognized in national treatment guidelines.'' In addition,
Sec. 423.120(b)(1)(v) requires that in making decisions about formulary
design, the entity designing the formulary must base ``clinical
decisions on the strength of scientific evidence and standards of
practice.''
Additionally, CMS requires Part D sponsors to submit utilization
management requirements applied at point of sale, such as prior
authorization, step therapy, and quantity limits not based upon the
FDA's maximum daily dose limits, as part of their Health Plan
Management System formulary submission. Sponsors must perform adequate
oversight of their PBMs and other delegated entities to verify that
they are complying with all CMS requirements and not causing
beneficiary harm due to impermissible delayed or denied access to Part
D drugs.
We will continue to monitor year-over-year formulary and
utilization management changes to assess if changes from the redesigned
Part D benefit have the potential to reduce access to vital
medications.
Question. A primary focus of the Department is to reduce
longstanding disparities in health outcomes. The Centers for Medicare
and Medicaid Services (CMS) have attempted to address some of these
health equity issues through actions such as the Comprehensive Kidney
Care Choices (CKCC) model. CMS' modified approach for 2024 and future
years is through a retrospective trend adjustment (RTA), but the lack
of an RTA for 2022 and 2023 spending benchmarks will result in
financial losses for participating practices, jeopardizing the ongoing
operations of the care model.
Will you commit to working with CMS to examine actions that the
agency could take to ensure continued participation in the CKCC model?
Answer. One of CMS's top priorities is to expand access to quality,
affordable health coverage and care. As of January 2024, the Kidney
Care Choices (KCC) model includes 123 Kidney Contracting Entities
(KCEs) and CMS Kidney Care First (KCF) practices, which are accountable
for the quality of care of their aligned people with Medicare. The KCC
model has more than 9,227 participating health care providers and
organizations, a 10-percent increase from 2023, serving 282,335 people
with Medicare who have chronic kidney disease and end-stage renal
disease in 2024. The strong participation in our accountable care
models in 2024 will help more people access high-quality coordinated
health care that will improve their quality of life.
Question. In the FY 2025 the proposed budget, the administration
has included additional offices, programs, and funding for industrial
base expansion and strengthening our domestic supply chains. I have
been closely tracking the work the Administration for Strategic
Preparedness and Response has been doing regarding industrial base
expansion (IBx), particularly as it relates to nitrile gloves and other
PPE. Despite the administration purportedly prioritizing these efforts,
it's come to our attention that ASPR recently canceled some of these
IBx contracts, notwithstanding the significant Federal investment
already made. This is concerning from both a public health and national
security perspective. My staff recently asked the following questions
of your staff. The answer was largely nonresponsive. Accordingly, I am
now asking them of you.
With the $600-million Federal investment in domestic glove
manufacturing, to date, how many gloves have been produced
domestically? What is our current capacity for domestic production?
What will our domestic production capacity be by the end of 2024?
Answer. Using COVID-19 supplemental appropriations, ASPR's Office
of Industrial Base Management and Supply Chain (IBMSC) expanded the
country's domestic manufacturing infrastructure, including domestic
glove manufacturing infrastructure ASPR was grateful for the
congressional funding provided for this work.
As of the date of the hearing, there are two active contracts
supporting domestic glove manufacturing: U.S. Medical Glove Company and
Showa.
U.S. Medical Glove Company has produced a total of 30 million
gloves as of the date of this hearing and has a production capacity of
11 million gloves per month. Under the contract with Showa,
manufacturing and production is anticipated to come online in March
2024 with total capacity of 16.6 million gloves per month.
Question. Have any of the funds originally allocated for the
completion of these projects been repurposed? If so, for which specific
projects or programs?
Answer. No funds originally allocated for the completion of these
projects were repurposed. ASPR has utilized all funding provided to
date for these efforts and has made significant investments to support
and buildout domestic manufacturing capabilities. ASPR was appropriated
$10 million in FY 2024 for continuation of these efforts.
ASPR requested $95 million in the FY 2025 President's budget to
support sustained efforts in domestic manufacturing.
Question. Can you explain the contract modification process? Does
ASPR allow for contract modifications when temporal milestones are
missed as a result of governmental time constraints and delays?
Answer. ASPR adheres to and follows all contracting regulations and
processes as outlined within the Federal Acquisition Regulation (FAR).
Under required processes, any modification to existing contracts begins
either when the Contracting Officer's Representative (COR) or the
contractor initiates a written request to the Contracting Officer. If
the modification is deemed appropriate by the Contracting Officer,
supporting documents are required to execute the modification. During
this process, the Contracting Officer works closely with the COR to
examine circumstances (who, what, when, where, why) that resulted in
the need for the requested modification. In cases where a cost change
is required, the Contracting Officer requires a full description of the
work to be changed or modified and an independent cost estimate.
Question. Does ASPR allow for contract modification when temporal
milestones are missed as a result of governmental time constraints and
delays?
Answer. ASPR adheres to and follows contracting regulations and
processes as outlined within the Federal Acquisition Regulation (FAR).
Under these regulations, ASPR can allow for contract modification when
temporal milestones are missed as a result of governmental time
constraints and delays.
Question. What is ASPR's process for considering and subsequently
determining contract termination? What factors does ASPR consider in
process of terminating existing IBx contracts--those terminated for
cause or for convenience?
Answer. It took the U.S. economy decades for industries to leave
our shores and go overseas, and it will take time and continued
investment to bring them back. ASPR continues to balance supporting
domestic manufacturers and spending taxpayer dollars in a way that
ensures appropriate management and oversight of existing contracts.
When deciding whether to terminate an IBx contract, ASPR adheres to
and follows the contracting regulations and processes as outlined
within the Federal Acquisition Regulation (FAR).
For contract terminations for cause, this process is initiated when
the Contracting Officer becomes aware of a performance deficiency,
i.e., missed milestones/deliverables that constitute failure to perform
or failure to make progress as to endanger performance of the contract.
The Contracting Officer validates whether the contractor has failed to
make delivery of the supplies or services or has failed to make
progress as to endanger performance of the contract. Once the
Contracting Officer validates the performance deficiency, the
contracting officer may determine to send a written Letter of Concern
to the contractor, or a Cure Notice in anticipation of a termination. A
Letter of Concern describes the technical, cost, or schedule problem
being experienced under the contract, and directs the contractor to
respond to the letter with some type of ``corrective action plan'' by a
certain date. In a situation where the contractor fails to deliver
supplies or services, or some other of the provisions of the contract,
or fails to make progress as to endanger performance of the contract,
the Contracting Officer can instead send a written Cure Notice to the
contractor stating specifically what deficiency exists and providing
the contractor 10 days to ``cure,'' or explain how it will ``cure,''
the failure to deliver or failure to make progress. When making the
termination decision, ASPR considers the contractor's cure response,
whether the contractor has explained in sufficient detail how the
contractor will meet the terms and conditions of the contract, and the
likelihood of the contractor successfully completing the contract
requirements.
______
Questions Submitted by Hon. Marsha Blackburn
Question. Medicaid Program; Misclassification of Drugs, Program
Administration and Program Integrity Updates Under the Medicaid Drug
Rebate Program. In the proposed rule, the Center for Medicare and
Medicaid (CMS) redefines ``best price'' in Medicaid. For more than 30
years, ``best price'' has been defined statutorily as the single lowest
price available from a manufacturer.
Please explain why your agency is looking to upend 30 years of
legal and practical precedent in an attempt to rewrite the Medicaid law
without Congress.
Stakeholders throughout the health care supply chain have raised
operational questions about the agency's proposed rule and how it would
be implemented. Specifically, there doesn't appear to be any system in
place to capture--from the manufacturer all the way down to the
pharmacy counter--all the data on rebates required to comply with the
proposed rule. It also doesn't appear that all entities in the supply
chain would be compelled to share the necessary data.
Please describe how your agency plans to set up such a system.
Do you plan to request additional congressional funding to build
out such a platform?
Answer. CMS is currently in the rulemaking process and cannot
comment on or speculate about any potential changes to the proposed
policies or when a final rule may be issued. As always, we are closely
reviewing the comments received in response to the proposed rule. Input
from stakeholders is an important contribution to CMS's policymaking
process, and we are now considering the abundance of comments we
received during the public comment period.
Question. One of the main drivers behind the enactment of the No
Surprises Act (NSA) was to give patients certainty on what they owe for
out-of-network services. To that end, the NSA established a method for
calculating patient cost sharing for out-of-network services that is
based on the ``recognized amount,'' which is distinct from the ``out-
of-network rate.'' If the ``out-of-network'' rate later turns out to be
higher than the ``recognized amount'' on which cost-sharing was
initially based, the patient is not later affected. Instead, according
to the NSA, the plan has to make up the difference to the provider. The
very first NSA interim final rule expressly confirmed this basic
structure. This is one of the most basic concepts in the NSA, which,
together with banning balance billing, keeps patients out of the
``middle'' of payment issues. Unfortunately, it's been brought to my
attention that health plans are changing the patient cost-sharing
amounts extremely late in the process and calculating patient cost-
sharing amounts based on the ultimate outcome of the independent
dispute resolution process.
Has the Department received reports of these kinds of cost-sharing
adjustments by plans?
What is the Department doing to ensure that health plans are held
responsible if patients receive erroneous bills based on health plans
incorrectly calculating patient cost sharing?
Answer. Patient cost sharing cannot be adjusted based on the IDR
payment determinations. Plans are required to calculate the cost-
sharing requirement as if the total amount that would have been charged
for the services by such participating provider or participating
emergency facility were equal to the recognized amount for such
services, which (for disputes that are eligible for the IDR process)
will be the lesser of the provider's billed amount or the QPA. By
requiring plans and issuers to calculate the cost-sharing amount using
the recognized amount, rather than the amount the plan or issuer
ultimately pays the nonparticipating provider or nonparticipating
emergency facility for the furnished items or services, the No
Surprises Act and the interim final rules limit the effect of provider-
payer disputes about payment amounts on participant, beneficiary, or
enrollee cost sharing. Under the statute and the interim final rules,
the provider or facility and plan or issuer separately determine the
total payment amount for the furnished items or services, but that
amount generally does not affect the cost-sharing amount the individual
must pay.
As a reminder, under the NSA, providers are also prohibited from
billing more than the amount of cost sharing (calculated using the
recognized amount, or in the case of air ambulance services, the lesser
of the billed amount or QPA). We have heard from stakeholders regarding
this concern and are actively investigating the issue.
Question. The NSA established an independent dispute resolution
(IDR) process to resolve disputed payment amounts between insurance
companies and providers. Providers have repeatedly informed Congress
that, even after the provider prevails in the IDR, health plans fail to
actually pay the amounts owed in the time frames specified in law and
regulation. In some instances, the insurers pay incorrect amounts; in
others, they fail to pay at all. Although the agency has an online
portal for complaints about these issues, providers consistently report
never receiving a response or follow-up communication from the agency.
This behavior by the plans poses a significant issue for cash flow for
providers and eviscerates one of the most fundamental provisions in the
law Congress passed.
What concrete enforcement plan does the Department have to support
the integrity of the IDR process for providers regarding nonpayment by
health plans?
Answer. Through the CMS investigation process, as of October 31,
2023, CMS has directed numerous plans, issuers, providers, health-care
facilities, or providers of air ambulance services to take remedial and
corrective actions to address instances of noncompliance, which has
resulted in approximately $3,018,432 in monetary relief paid to
consumers or providers. To provide transparency into our processes, CMS
has begun to publish data on the resolution of certain consumer
complaints, including complaints related to NSA (see: https://
www.cms.gov/files/document/enforcement-report-11-23.pdf). CMS intends
to update this chart regularly. Most consumer submissions involve
requests for basic information about the NSA, complaints related to
potential balance billing in cases of nonemergency or emergency
services, or complaints that a good faith estimate was not provided for
scheduled care or upon request.
The Departments continue to receive provider complaints alleging
that payers are not complying with the Federal IDR process
requirements. Most provider complaints allege that payers have failed
to abide by the requirement to pay the prevailing party within 30 days
of a payment determination by a certified IDR entity, or that payers
incorrectly calculated QPAs. The Departments take the issue of late
payments and failures to pay after IDR payment determinations very
seriously. In general, the Departments have seen progress in payers
processing IDR payments when reaching out in response to complaints.
Additionally, based on our investigations, we have made operational
changes to help mitigate issues we have identified. These changes
include developing a new payment determination template for certified
IDR entities to use which includes claim line-level details and
developing a process for sending these templates through the Federal
IDR portal. While we believe these operational enhancements should help
mitigate some of the identified issues related to missing information,
we continue to investigate complaints as they are received. It is
important to note that to date, most complaints have come from a few
distinct provider groups that allege violations from a few distinct
plans and issuers. However, to ensure that the Departments are aware of
all issues related to timely payment, the Departments continue to
strongly encourage parties who use the Federal IDR process to submit
complaints to the No Surprises Help Desk (NSHD).
CMS is actively investigating and addressing complaints under its
jurisdiction. If a violation is found, CMS has the authority to enforce
the requirement.
Question. In August of 2023, a Federal court in Texas Medical
Association, et al. v. U.S. Department of Health and Human Services, et
al., Case No. 6:22-cv450-JDK (TMA III) invalidated the Department of
Health and Human Services (HHS) regulations governing how insurers
calculate Qualified Payment Amounts (QPAs) under the NSA. In response,
the Department indicated it would appeal the court's ruling and
exercise enforcement discretion to allow insurers to use invalidated
QPAs during the appeal process. On January 12, 2024, the Department
decided to withdraw its appeal regarding several important parts of the
court's ruling which prohibited insurers from (1) using any out-of-
specialty rates and (2) using the rates of other self-funded plans in
calculating QPAs. It's been more than 2 months since that decision, yet
the Department has failed to issue any guidance instructing insurers
and IDRs to follow the law.
When will the Department be issuing that update?
Answer. On August 24, 2023, the United States District Court for
the Eastern District of Texas (district court) issued an opinion and
order in TMA III vacating certain provisions of the July 2021 interim
final rules as well as certain portions of several No Surprises Act
guidance documents issued by the Departments. The district court in TMA
III held that several provisions of the regulations and guidance are
unlawful and vacated and remanded them for further consideration. On
October 6, 2023, the Departments released additional frequently asked
questions (FAQs) regarding implementation of certain provisions of
title I (the No Surprises Act) of Division BB of the Consolidated
Appropriations Act, 2021 (FAQs part 62), in light of the August 24,
2023, decision in TMA III. The decision in TMA III requires certain
changes to the methodology that is used to calculate a QPA. The Federal
Government appealed parts of the TMA III decision to the Fifth Circuit
and submitted a brief to the court in January 2024 (see: Brief of
Appellant Texas Medical Association v. U.S. Department of Health and
Human Services, No. 23-40605 (5th Cir. January 12, 2024), ECF No. 42).
Regulatory text that was not vacated remains in effect and is key to
operation of the Federal IDR process. Therefore, plans and issuers are
required to calculate QPAs in a manner consistent with the statutes and
regulations that remain in effect after the TMA III vacatur.
Accordingly, plans and issuers are expected to calculate QPAs using a
good faith, reasonable interpretation of the applicable statutes and
regulations that remain in effect after the TMA III decision.
Question. In the Contract Year 2025 Medicare Advantage (MA) and
Part D proposed rule, CMS proposes certain changes to agent and broker
compensation for enrolling individuals in MA plans. The proposed rule
has implications for Medicare beneficiaries, field marketing
organizations (FMOs), and agents and brokers who all play important
roles in helping seniors select and enroll in the MA plan that best
meets their needs, and it is important that there not be any unintended
consequences that could adversely impact beneficiaries.
Will you affirm that the proposed limit on fees for administration
services is intended to apply only to payments that agent and brokers
receive from MA plans, and not to payments that FMOs receive separately
from carriers?
Will you commit to making sure that this intent is clear in any
final rule to ensure there are no unintended consequences for seniors
in MA?
Will you commit to engaging FMOs and other relevant stakeholders
prior to issuing any future rulemaking that could affect the FMO
business model and FMOs' ability to enter into service contracts with
carriers to ensure there are no adverse impacts to our Nation's
seniors?
Answer. We agree that it is critical to ensure that as the MA
program continues to grow, it remains viable and that seniors and
individuals with disabilities eligible for Medicare can make informed
decisions about their health-care coverage, and, when appropriate,
enroll in the plan that is best suited to their personal health-care
needs. As discussed in the CY 2025 MA and Part D proposed rule, section
1851(j) of the Social Security Act requires that CMS develop guidelines
to ensure that the use of compensation creates incentives for agents
and brokers to enroll individuals in the MA plan that is intended to
best meet their health-care needs. We have learned, however, that many
MA and stand-alone prescription drug plans (PDP), as well as third-
party entities with which they contract (such as field marketing
organizations (FMO)), have structured payments to agents and brokers
that have the effect of circumventing existing CMS regulations that
limit agent and broker compensation to specified fair market value
(FMV) levels. CMS has also received complaints from different
organizations, including State partners, beneficiary advocacy
organizations, and MA plans to this effect. A common thread to the
complaints is that agents and brokers are being paid, typically through
various purported administrative and other add-on payments, amounts
that cumulatively exceed the maximum compensation allowed under the
current regulations. Moreover, CMS has observed that such payments have
created an environment, not dissimilar to what originally prompted us
to set limits on agent and broker compensation in 2008, where the
amounts being paid for activities that do not fall under the umbrella
of ``compensation,'' are rapidly increasing.
We understand that FMOs help millions of Medicare beneficiaries to
learn about and enroll in Medicare, Medigap, MA plans, and PDP plans by
providing guidance on plan options, including comparisons of relative
costs and coverage, as well as assisting beneficiaries with applying
for financial assistance.
In our proposed rule, CMS is focused on current payment structures
among MA organizations, agents, brokers, and third-party marketing
organizations (TMPO), including FMOs, that may incentivize agents or
brokers to emphasize or prioritize one plan over another, irrespective
of the beneficiary's needs, leading to enrollment in a plan that does
not best fit the beneficiary's needs and a distortion of the
competitive process. In this rule, CMS has proposed to: (1) generally
prohibit contract terms between MA organizations and agents, brokers,
or other TMPOs that may interfere with the agent's or broker's ability
to objectively assess and recommend the plan which best fits a
beneficiary's health-care needs; (2) set a single agent and broker
compensation rate for all plans, while revising the scope of what is
considered ``compensation;'' and (3) eliminate the regulatory framework
which currently allows for separate payment to agents and brokers for
administrative services.
The comment period for the CY 2025 MA and Part D proposed rule
closed on January 5, 2024. CMS sought comment on these proposals to
further inform our calculations and policy direction. We have received
feedback from many interested parties on our proposed policy, and we
will carefully consider these comments throughout this rulemaking
process.
Question. The administration has estimated a change in the national
per-capita MA growth percentage to 1.98 percent for 2025. This is a
lower than expected and inadequate update from the 2024 proposed (1.81
percent) and finalized rates (1.60 percent), and considerably lower
than the finalized rate for 2023 (4.75 percent). Similarly, the
estimation does not appear to be aligned with recent figures in the
2023 Medicare trustees report from CMS's Office of the Actuary 2025
that shows average incurred costs per beneficiary at 5.8 percent.
Additionally, recent projections from Berkeley Research Group also show
that MA medical cost inflation will increase by 4 to 6 percent in 2025.
How specifically did the administration arrive at this figure for
2025?
What justification is there for such low estimates over the last 2
years?
What explains the discrepancy with estimates provided by the
administration's own actuarial office?
Answer. As required by statute, the growth rates used in the
calculation of the MA rates reflect growth in per capita costs for non-
ESRD individuals enrolled in either Medicare FFS or Medicare health
plans. The growth rates are based on the expected change in United
States Per Capita Costs in Fee-for-Service (FFS USPCC) and in Medicare
overall (both FFS and MA) and, as such, are largely driven by trends in
per capita costs for individuals in Medicare FFS. The Effective Growth
Rate of 2.44 percent reported by the CY 2025 MA and Part D advance
notice is a national average of expected change in the per capita costs
year over year. The main driver of the Effective Growth Rate is the FFS
USPCC, with the total USPCC used to calculate the pre-ACA benchmark cap
amount for each county. The growth percentages are based on CMS's best
estimate of historical Medicare FFS program experience and projected
trends in Medicare FFS program payments using the most up-to-date data
available. CMS continues to consider it best practice to base the
growth rates on the most recent data and assumptions available at the
time those values are announced. Therefore, for each release of the
growth rates, CMS updates historical experience, as well as projection
factors, based on the most recent data.
Question. The Food and Drug Administration (FDA) has previously
recognized the importance of patient access to medicines during the
pandemic and granted enforcement discretion for compounded medications
in shortage. The list of medicines in shortage continues to limit
patient access to vital medications, but the agency has been slow to
respond. In fact, as of March 12, 2024, there were 144 products listed
on FDA's drug shortage database. There is widespread agreement among
health-care providers that there are problems with the current process
used by the FDA to establish the agency's drug shortage list. The FDA
list does not consider direct input from health-care practitioners.
What is the Administration's short-term and long-term plan to
alleviate drug shortages?
Answer. HHS recognizes the severe patient impact from the
persistent problem of chronic drug shortages that have most frequently
impacted inexpensive generic drugs, particularly sterile injectables.
HHS is taking a coordinated approach to help address economic root
causes of shortages.
In November 2023, HHS announced the establishment of a new Supply
Chain Resilience and Shortage Coordinator role responsible for
coordinating efforts across the Department that advance the resilience
of medical product and food supply chains and accelerate the
Department's response to related shortages. Institutionalizing this
coordination across the Department will help HHS meet its long-term
supply chain resilience and shortage mitigation goals. In addition, FDA
on an ongoing basis works to identify shortage risks and determines
actions that can prevent or mitigate patient impact, such as
prioritizing review of manufacturer submissions or working with
manufacturers to increase supply. ASPR also led the development of an
Essential Medicines Supply Chain and Manufacturing Resilience
Assessment to identify supply chain vulnerabilities in a critical
medicines list and has invested, through the Industrial Base Management
and Supply Chain (IBMSC) Office, targeted funds to bolster domestic
manufacturing capabilities for essential medicines.
CMS is also taking steps to help align certain incentives to
bolster supply chain resilience and further promote adoption of
resilient supply chain practices. As discussed in the CY 2024
Outpatient Prospective Payment System (OPPS) final rule, CMS solicited
public comment on providing separate payment under the Medicare
Inpatient Prospective Payment System (IPPS), and potentially the OPPS,
for establishing and maintaining access to a buffer stock of essential
medicines to foster a more reliable, resilient supply (88 FR 82127-30).
CMS also noted in the CY 2024 OPPS final rule that as part of the
agency's initial efforts, CMS intends to propose new Conditions of
Participation in forthcoming notice and comment rulemaking addressing
hospital processes for pharmaceutical supply (88 FR 82130). CMS
continues to review the comments received to consider ways the Medicare
program can promote hospital resilience practices and help mitigate the
impact of drug shortages on patients.
Going forward, HHS is working to identify opportunities to reduce
the risks of drug shortages. Examples of these include:
Gaining fuller insight into the supply chain. Interruptions or
problems in the drug supply chain can create or worsen drug shortages.
The Federal Food, Drug, and Cosmetic Act, as amended by the Coronavirus
Aid, Relief, and Economic Security Act, requires manufacturers to
notify FDA of active pharmaceutical ingredient (API) manufacturing
discontinuances or interruptions of certain drugs under certain
circumstances and includes a requirement for firms to report annually
the amount of listed drugs they manufacture for commercial
distribution, but it does not require reporting of shortages due to
increased demand. Expressly including this requirement would greatly
assist FDA's work to prevent and mitigate drug shortages.
Increasing the resilience of the drug supply chain. Drug
manufacturing in more than one facility and more than one geographic
region can provide agility that reduces the risk of drug shortages and
helps with resolution of shortages when they occur. For example, if a
manufacturing facility needs to temporarily close, or its operations
are curtailed by factors such as travel restrictions, quarantines, or
natural disasters, it is important to have alternative facilities
available to manufacture the drug or its API. FDA is ready to work with
manufacturers to address these needs. Furthermore, an express statutory
requirement that drug manufacturers provide data identifying the
suppliers they relied on to manufacture a listed drug, in reporting on
the annual amount of the drug manufactured for commercial distribution,
and the extent of such reliance, would help FDA identify
vulnerabilities in the supply chain that may be hidden.
Overall, important progress has been made in preventing drug
shortages from occurring, and FDA continues to work to ensure that
patients in the United States have access to the medicines they need.
FDA has put forth legislative proposals in its fiscal year 2025
proposed budget that address the example above (https://www.fda.gov/
media/176924/download?attachment). If enacted, these proposals would
greatly enhance the FDA's ongoing work to address potential drug
shortages.
Question. Would the FDA consider amending its definition of ``drug
shortage'' to include input from health-care practitioners to better
align the process used by the FDA to establish the shortage list, which
could expedite and improve the process at FDA?
Answer. FDA continues to welcome input from health-care
practitioners regarding drug shortages. In fact, March 2024 marks FDA's
launch of a new portal \64\ for patients, consumers, and health-care
practitioners to report potential drug shortages.\65\ The new public
portal allows anyone, including health-care practitioners, to submit
shortage information through an online form directly into FDA's Center
for Drug Evaluation and Research's NextGen system.
---------------------------------------------------------------------------
\64\ https://cdernextgenportal.fda.gov/publicportal/s/dsm-
submission.
\65\ https://www.fda.gov/drugs/drug-safety-and-availability/drug-
shortages.
Since 2017, NextGen has been a way for regulated industry to
communicate with FDA, including by submitting information on shortages,
discontinuations, and anticipated supply disruptions. Prior to the new
portal, nonindustry stakeholders have had to report information about
---------------------------------------------------------------------------
potential shortages to FDA's Drug Shortages Staff by email.
Expanding access to NextGen's shortage reporting beyond regulated
industry will allow for greater consistency and ease of reporting by
outside stakeholders, and greater efficiency in tracking and responding
to these reports. Early notification from health-care practitioners and
others about drug shortages or potential supply challenges can help FDA
staff take action to quickly resolve or reduce the duration of the
shortage. FDA staff investigate every notification submitted through
NextGen to determine if the nationwide demand for the drug exceeds
available supply. If the Drug Shortages team determines a shortage
exists, they will add that product to FDA's Drug Shortages Database.
Question. Ensuring that Medicare beneficiaries can obtain accurate
and timely diagnoses is critical to improved outcomes and quality of
life for seniors. From a Medicare spending perspective, accurate and
timely diagnoses are essential to avoid more expensive treatment
courses resulting from delayed diagnoses and repeat scans. To that end,
the HHS should ensure that Medicare's payment system for hospital
outpatient services does not create disincentives for hospitals to use
cutting-edge diagnostic radiopharmaceuticals, such as those used in PET
scans, to detect diseases in early stages, including prostate cancers
and other cancers. Last year, the Centers for Medicare and Medicaid
Services (CMS) sought information from stakeholders on Medicare payment
approaches that could avoid payment disincentives for these innovative
diagnostic radiopharmaceuticals, but the agency has not yet proposed a
policy path forward.
Will you commit to working with me and my office to help ensure
that Medicare payments provide the appropriate incentive for hospitals
to utilize innovative diagnostic radiopharmaceuticals for imaging
scans?
Answer. Under the OPPS, CMS packages several categories of nonpass-
through drugs, biologicals, and radiopharmaceuticals, regardless of the
cost of the products. In particular, under Sec. 419.2(b)(15), payment
for drugs, biologicals, and radiopharmaceuticals that function as
supplies when used in a diagnostic test or procedure is packaged with
the payment for the related procedure or service. Diagnostic
radiopharmaceuticals, which include contrast agents, stress agents, and
other products, are one specific type of product that is packaged under
this policy.
In the CY 2024 OPPS/ASC proposed rule, CMS solicited comment on a
number of potential new approaches to payment for diagnostic
radiopharmaceuticals that would enhance beneficiary access, while also
maintaining the principles of the outpatient prospective payment
system. Overall, commenters described clinical scenarios in which they
believed CMS's payment policies created the most significant access
issues, and accordingly, commenters urged CMS to reform payment policy
for diagnostic radiopharmaceuticals to address these concerns. However,
there was not a general consensus among commenters as to the most
effective way for CMS to reform its OPPS diagnostic radiopharmaceutical
payment policy.
CMS agrees this is a complex and important issue, and given the
wide array of information presented through the public comment process,
we intend to further consider these points and take them into
consideration for future notice and comment rulemaking. CMS welcomes
ongoing dialogue and engagement from stakeholders regarding suggestions
for potential future payment changes and would be happy to provide
technical assistance on any draft legislation.
Question. Despite the advancements in prevention, treatments, and
therapies, challenges to access and disparities in care persist in the
U.S. health system. Factors such as geographic inaccessibility,
economics, insurance, workforce shortages, and many other factors
contribute to this growing trend. In addition, for many conditions,
access to evidence-based first-line therapy is limited at best,
reducing care quality, negatively impacting population health, and
increasing total health-care costs. Many prescription digital
therapeutics offer clinically validated interventions for a variety of
mental health and substance use disorder conditions and can help fill
the gap for many beneficiaries. The very nature of prescription digital
therapeutics also provides opportunities to achieve access to evidence-
based care at scale, especially for underserved populations. However,
the lack of Medicare coverage has hindered the uptake of these much-
needed products and prevented Medicare beneficiaries from accessing
them. In the CY 2024 Physician Fee Schedule proposed rule, CMS took an
important step by including a request for information regarding
coverage for prescription digital therapeutics. Medicare's leadership
in covering and paying for these new medical technologies is key to
expanding access to care and helping to address provider shortages
across a wide range of professionals, including mental health provider
shortages that have driven the ongoing mental health crisis in the
United States and globally.
What is CMS doing to ensure beneficiary access to prescription
digital therapeutics?
Answer. As of April 2022, CMS has created 1 billable procedural
code for ``prescription digital behavioral therapy, FDA-cleared, per
course of treatment.'' CMS believes that establishing such a code may
facilitate options for non-Medicare payers to provide access to this
therapy in the home setting. CMS continues to be open to hearing from
manufacturers and payers about their experience in implementing this
code and is willing to work with Congress to increase access to care
through an emerging field.
In the CY 2023 PFS final rule, CMS noted that we accepted the
Relative Value Scale Update Committee's (RUC's) recommendation to
contractor price CPT code 98978, a PE-only code that describes
provision of a monitoring device for cognitive behavioral therapy (CBT)
and that we would work with our Medicare Administrative Contractors
(MACs) to better understand the kinds of devices and device costs they
are encountering as they review claims for payment for the services
described by this code. Additionally, in the CY 2024 Physician Fee
Schedule final rule, we noted that the existing codes described by CPT
codes 98978, 98980, and 98981 allow for the billing of remote
therapeutic monitoring services, including monitoring patient adherence
and therapy response for use with cognitive behavioral therapy. CMS
continues to be interested in any feedback from interested parties on
this topic, including feedback from interested parties about any
potential codes that we would review under those processes and
considerations we might need to take into account for future rulemaking
to improve the accuracy of coding and payment under the Medicare PFS
(88 Fed Reg 79103).
Question. I want to thank CMS for finalizing a National Coverage
Determination (NCD) for coverage of power seat elevation systems in
2023. As you know, I've long advocated for access to these important
systems for people with disabilities like paralysis, muscular
dystrophy, ALS, and spina bifida. Additionally, I've been asking CMS to
consider power-standing systems for these consumers as well. There is a
significant body of clinical evidence suggesting these systems can be
incredibly valuable to the medical and health outcomes of patients with
significant mobility impairments.
When do you plan to open the NCD for coverage of power standing
systems?
Answer. Millions of people with Medicare rely on medically
necessary assistive devices to perform daily tasks that directly impact
their quality of life. CMS remains committed to ensuring persons with
disabilities are receiving available benefits that improve their
health. CMS follows a longstanding process established by Congress to
determine whether a medical item or service can be covered nationally
by Medicare, including when an item or service is reasonable and
necessary for the diagnosis of and/or treatment of an illness or
injury.
Although CMS has accepted a request for a national coverage
determination for power standing systems, we have not been able to act
on it yet due to our internal capacity restraints. As CMS indicated in
the August 2013 Federal Register notice, ``In the event that we have a
large volume of NCD requests for simultaneous review, we prioritize
these requests based on the magnitude of the potential impact on the
Medicare program and its beneficiaries and staffing resources,'' 78
Fed. Reg. 48168 (August 7, 2013). This is not meant to minimize the
importance of this request; it only reflects the limitations of our
available resources. This request will be considered in the future as
we prioritize the requests for NCDs.
______
Questions Submitted by Hon. Elizabeth Warren
Question. Maximus contracts with the Federal Government to provide
call center operations for Medicare, Medicaid, and the Affordable Care
Act (ACA). Maximus's 9-year Contact Center Operations (CCO) contract is
valued at $6.6 billion and represents the company's single largest
contract. About 10,000 customer service agents are employed under this
contract at 10 call centers in 8 States. Employees at these call
centers are mostly women of color.
In response to reports of low wages, unacceptable working
conditions, and racial inequity at Maximus's Federal call centers, and
following some of the largest Federal call center worker strikes in
history, the Department of Health and Human Services (HHS) announced in
December 2023 that it would rebid Maximus's contract to include a labor
harmony provision. Yet according to the Communication Workers of
America (CWA), the union representing Maximus's Federal call center
workers, HHS, and the Centers for Medicare and Medicaid Services (CMS)
have claimed that the process of recompeting the call center contract
could take as long as 30 months. This is an unusually long timeline for
such a contract: for comparison, Maximus won the most recent CMS call
center contract in September 2022, roughly 15 months after proposals
were due to CMS in July 2021.
What are the steps HHS, CMS, or other agencies must take in the
rebidding process? What is the specific timeline for each step? At what
step of the process is HHS currently?
Why is the process for rebidding the CMS call center contract
expected to take 30 months?
What actions can HHS and CMS take to streamline the rebidding
process so as not to prolong call center workers' hardship? Has HHS or
CMS taken any such action to date?
Answer. Offering best-in-class customer service is a top priority
for HHS, and that includes service provided to American families
through 1-800-MEDICARE and the ACA marketplace call centers. In June
2023, CMS issued a Request for Information on the call center contract
requesting input in major areas, including a labor harmony requirement
(available at: https://sam.gov/opp/7c4e9a33081d44049ded7360
ae9ec7c9/view). In the interest of customer service and continuity of
operations, CMS will, under the legally required process, recompete its
contract for the Medicare and ACA marketplace call centers. CMS
anticipates issuing a ``Sources Sought'' notice to determine the
potential bidder pool in March 2024.
Question. The Department of Health and Human Services aims to
``achiev[e] universal legal representation for unaccompanied children
by 2027.'' Without legal counsel, it is virtually impossible for
unaccompanied children to navigate the complex and adversarial U.S.
immigration system and to understand and defend their legal rights.
Legal representation of children also prevents waste of judicial and
other government resources, given that attorneys can help screen out
inapplicable forms of protection, minimize unneeded court time, and
avert hearing postponements that would otherwise be necessary to afford
children an opportunity to obtain counsel. Furthermore, attorneys help
combat labor exploitation, sometimes serving as the only authority
figure in whom children feel safe confiding information about workplace
abuses.
Can you share in more detail the actions the Office of Refugee
Resettlement (ORR) will take in FY 2024 and beyond to expand legal
services for unaccompanied children?
How can Congress support ORR in its expansion of legal services for
unaccompanied children?
Answer. By statute, HHS's ORR is responsible for the care and
placement of unaccompanied children who are in Federal custody by
reason of their immigration status, from the moment they enter ORR
custody from the Department of Homeland Security (DHS) or other Federal
entity, to when they are safely placed with a vetted sponsor who has
undergone a robust screening process. See 6 U.S.C. 279; 8 U.S.C.
1232(b)-(c). As part of this mission, consistent with legal
requirements, ORR arranges legal services for some unaccompanied
children to assist them in their immigration proceedings and provides
legal information to each child upon entering ORR care. See 8 U.S.C.
Sec. 1232(c)(5).
ORR's Unaccompanied Children (UC) Program Policy Guide Section 3.7,
states that when in ORR custody, unaccompanied children should receive
``Know Your Rights'' (KYR) presentations on immigration law and the
children's rights and responsibilities and legal screenings within 10
business days of admission. ORR contracts with a legal service provider
to administer the KYR presentation and legal screenings. The contractor
also provides direct representation for a limited number of children in
ORR care and upon release from ORR. Direct representation means
attorneys enter into a representation agreement with unaccompanied
children to represent them before the immigration court, U.S.
Citizenship and Immigration Services and/or State court in the child's
defense against removal and application for affirmative petitions, such
as applications for asylum or adjustment of status through Special
Immigrant Juvenile Status.
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 CY 2027. Congress can support this effort
with additional funding and resources. Due to shortages of appropriate
legal service providers, ORR anticipates that it will take several
years to scale up to the capacity in the legal service field necessary
to serve all unaccompanied children, which will require investments in
attorney recruitment and training, mentoring programs and
opportunities, and technical support for the pro bono network. More
funding from Congress would help address issues identifying and
retaining legal service providers and build up contract capacity so
that more children have legal representation.
Currently, direct representation is prioritized for the most
vulnerable cases, including children who are expected to have a longer
stay in ORR care, such as those in long-term foster care or those who
do not have an identified sponsor, and children for whom courtroom
assistance does not satisfy the legal needs of the individual child,
such as those who are seeking voluntary departure or who otherwise have
complex legal needs.
In response to these needs, ORR awarded a 5-year legal services
contract in March 2022 and expanded that contract to invest in legal
service provider capacity building, by expanding to new, previously
unserved or underserved areas and bringing on new attorneys. ORR also
plans to award one or more new contracts for additional direct legal
representation capacity in FY 2024, which will also expand
representation for unaccompanied children who have been released from
ORR care, as current appropriations from Congress allow.
Question. In August 2023, the Department of Health and Human
Services recommended that the Drug Enforcement Administration (DEA)
reschedule marijuana from Schedule I of the Controlled Substances Act
to Schedule III. The recommendation explained that marijuana ``does not
produce serious outcomes compared to drugs in Schedules I or II,'' and
``the vast majority of individuals who use marijuana are doing so in a
manner that does not lead to dangerous outcomes to themselves or
others.'' Though HHS recommended placing marijuana in Schedule III, its
recommendation also explained that marijuana's rate of adverse outcomes
is lower than that of alcohol, which is not scheduled in the Controlled
Substances Act, and that the ``risks to the public health posed by
marijuana are low compared to other drugs of abuse,'' such as
benzodiazepines (a Schedule IV drug). The DEA is currently reviewing
HHS's recommendation. Additionally, according to a recent report, HHS
has asked the Justice Department's Office of Legal Counsel (OLC) to
provide input on legal issues related to rescheduling marijuana.
Relatedly, in 2022 the Medical Marijuana and Cannabidiol Research
Expansion Act directed HHS to report to Congress ``the potential
therapeutic effects of cannabidiol or marijuana on serious medical
conditions'' by December 2023.
Please describe how marijuana's abuse potential and risk to public
health compares to that of alcohol, which is not scheduled in the
Controlled Substances Act.
If HHS has sought OLC's input on the topic of rescheduling or de-
scheduling marijuana, what question(s) did HHS raise for OLC? Has HHS
received a response from OLC?
What is the status of the HHS report mandated by the Medical
Marijuana and Cannabidiol Research Expansion Act, and when should
members anticipate its release?
Answer. All drug use comes with risk, though different drugs pose
different potential health effects and associated harms. While many of
the health effects of alcohol have been well established through
decades of research, we do not have the same evidence base for cannabis
at present. Rigorous research on the potential risks, benefits, and
health effects of cannabis use is urgently needed.
Cannabis use among adults has increased in recent years, alongside
an increase in doses and regular patterns of consumption. At the same
time, there are well-
documented adverse health effects associated with cannabis use
including addiction, respiratory problems, accidents, psychosis, and
cardiovascular events. Using cannabis every day, or almost every day,
is associated with developing cannabis use disorder, cannabis-induced
psychosis, and other adverse mental health effects--especially if a
person starts using cannabis at a young age.
The U.S. Food and Drug Administration (FDA) has not approved a
product containing whole cannabis or marijuana plant material for any
purpose. However, the FDA has approved synthetic THC-based medications
(dronabinol and nabilone), to treat nausea and vomiting associated with
cancer chemotherapy and to treat anorexia and weight loss associated
with HIV/AIDS. The FDA has also approved a plant derived CBD-based
medication (cannabidiol) to treat seizures associated with rare forms
of epilepsy.
There is evidence that cannabis can be effective in treating some
forms of pain, and there is emerging evidence that it may have
additional therapeutic uses. Research will continue to explore
potential therapeutic effects of cannabis to help inform individual and
public health decisions, including strategies to minimize potential
harms associated with cannabis use.
HHS did not request that the Office of Legal Counsel conduct an
analysis of legal issues related to rescheduling marijuana.
The landscape of cannabis research and policy is complex. As with
any deliverable to Congress, the agency works as hard as possible to
meet the appropriate deadlines. The report will be submitted to
Congress as soon as it is completed.
Question. Medical neglect is rampant in jails, prisons, and
immigration detention facilities. The quality of medical, mental, and
dental care in these facilities routinely falls far below the community
standard of care. It is estimated that a person loses 2 years in life
expectancy for every 1 year spent behind bars. Meanwhile, individuals
in custody often have greater health needs than the general population.
An estimated 50 percent of individuals in State and Federal prisons
have had a chronic health condition and around 37 percent of
individuals in prisons have a mental illness--roughly double the share
in the general population. COVID-19 helped reveal the lack of health
infrastructure in custodial facilities, yet given the lack of health
data reporting, these facilities largely remain a black box.
What steps is HHS taking to help address the crisis of poor health
and substandard health care in jails, prisons, and immigration
detention facilities?
For prisons and jails that receive Medicaid funds pursuant to 1115
waivers of the Medicaid Inmate Exclusion Policy, what data on the
health status of individuals in custody or data on the provision of
health services will the Centers for Medicare and Medicaid Services
(CMS) ask facilities to report (if any)?
What additional health data is CMS considering collecting from
jails and prisons that receive Medicaid funds?
What health-related technical assistance does the Centers for
Disease Control and Prevention (CDC) currently provide in jails,
prisons, and/or immigration detention facilities?
What health-related data does CDC collect from such facilities?
What additional technical assistance or data collection is CDC
considering providing or performing in such facilities?
Answer. CMS understands data related to carceral status, release
and reentry details, Medicaid eligibility, and the health-care needs of
individuals who are incarcerated and returning to the community may
reside in fragmented systems, including nonelectronic systems. This may
present some challenges in data sharing for purposes of case management
and collection of data for the Reentry Section 1115 Demonstration
Opportunity.
To support monitoring activities, a State with an approved Reentry
Section 1115 Demonstration will be expected to include information in
its demonstration quarterly and annual monitoring reports that, among
other things, details performance measures representing key indicators
of progress toward meeting the milestones for the demonstration. CMS
expects such metrics to include, but not be limited to: administration
of screenings to identify individuals eligible for pre-release
services, participating pre-release services providers, utilization of
applicable pre-release and post-release services (e.g., primary,
behavioral, medications for opioid use disorder, case management),
provision of health or social service referral pre-release,
participants with established care plans at release, and takeup of data
system enhancements among participating carceral settings.
Additionally, the State will be expected to report quality of care and
health outcomes metrics known to be important for closing key quality
and health equity gaps in Medicaid/CHIP (e.g., the National Quality
Forum ``disparities-sensitive'' measures) and prioritizing key outcome
measures and their clinical and non-clinical (i.e., social) drivers of
health. Not all measures on the list will be applicable based on a
State's demonstration design. The State and CMS will collaborate to
determine the appropriate measures the State will report. The
monitoring reports will also be expected to include qualitative
information that will align with the milestones outlined above,
including but not limited to the State's progress on data development
and exchange. A State will also be expected to conduct independent and
robust interim and summative evaluations. Outcomes of interest could
include, but are not limited to, measurement of cross-system
communication and collaboration, connections between carceral settings
and community services, provision of preventive and routine physical
and behavioral health care, and avoidable emergency department visits
and inpatient hospitalizations, as well as all-cause deaths. To the
extent feasible, the State will be expected to collect data to support
analyses stratified by key subpopulations of interest (e.g., by sex,
age, race/ethnicity, primary language, disability status, geography,
and sexual orientation and gender identity).
______
Submitted by Hon. Marsha Blackburn,
a U.S. Senator From Tennessee
United States Senate
washington, dc 20510
April 27, 2023
The Honorable Xavier Becerra
Secretary
Department of Health and Human Services
Washington, DC 20528
Dear Secretary Becerra:
As I expressed when you appeared before the Senate Finance Committee
last month, I am deeply concerned regarding the recent reports that the
Department of Health and Human Services (HHS) has mishandled
unaccompanied migrant children by placing them with unvetted sponsors,
leading to their exploitation and forced labor.
President Biden's border crisis has placed illegal immigrants in
dangerous--and often deadly--situations, and the over 250,000
unaccompanied minors who have crossed our southern border over the last
2 years are no exception.\1\ As you know, many of these children who
have been placed with sponsors have been forced to work dangerous jobs
across the country in violation of child labor laws. By losing contact
with over 85,000 children, your Department has failed to uphold its
basic obligation to ensure that these children are placed with sponsors
who will protect them. Even more troubling, initial reporting indicated
that case management officers were aware of children in exploitative
situations, yet the Department did not act.\2\ Democrats have spent
years telling the American people that their immigration policies are
compassionate and humane, but there is nothing compassionate about
turning a blind eye to the victimization of children.
---------------------------------------------------------------------------
\1\ Hannah Dreier, Alone and Exploited, Migrant Children Work
Brutal Jobs Across the U.S., N.Y. Times (February 28, 2023), https://
www.nytimes.com/2023/02/25/us/unaccompanied-migrant-child-workers-
exploitation.html.
\2\ Id.
When questioned at the hearing, you indicated that you were not aware
that children were being forced to work in dangerous jobs for long
hours, nor were you familiar with the fact that 85,000 children had
gone missing under your watch. While you claimed you were uninformed
about this situation, reporting following your testimony indicates a
grave dereliction of duty. According to The New York Times, staffers
and outside contractors informed HHS multiple times that migrant
children appeared to be at risk of exploitation, and they even
presented evidence that allegedly reached your desk. Not only were
these individuals ignored, but they were punished for daring to
challenge you.\3\ This reporting directly contradicts your previous
testimony.
---------------------------------------------------------------------------
\3\ Hannah Dreier, As Migrant Children Were Put to Work, U.S.
Ignored Warnings, N.Y. Times (April 17, 2023), https://www.nytimes.com/
2023/04/17/us/politics/migrant-child-labor-biden.
html.
These allegations of the Department ignoring these concerns are deeply
troubling, but even if they are untrue, the Department is clearly
guilty of gross incompetence. I am requesting answers regarding the
abuse and exploitation of these children that were entrusted to your
Department, and I am committed to holding accountable every individual
---------------------------------------------------------------------------
responsible for this dereliction of duty.
Please respond to the following questions by May 4, 2023.
1. When did you learn of the mishandling and exploitation of
migrant children who were released by HHS to unvetted sponsors?
2. Are you aware that, under Federal law, it is a crime to
``knowingly and willfully'' make a ``materially false'' statement to
Congress? \4\
---------------------------------------------------------------------------
\4\ 18 U.S.C. Sec. 1001(a)(2).
3. Please provide any reports, correspondence, or other
documentation that you received regarding the potential exploitation of
---------------------------------------------------------------------------
these migrant children.
4. The Department's Office of the Inspector General released a
report indicating that several demotions and dismissals of individuals
who raised concerns about migrant child safety ``may have risen to the
level of whistleblower chilling.'' \5\ Did you personally approve these
demotions and dismissals?
---------------------------------------------------------------------------
\5\ U.S. Department of Health and Human Services, Office of
Inspector General, Operational Challenges Within ORR and the ORR
Emergency Intake Site at Fort Bliss Hindered Case Management for
Children (2023), https://oig.hhs.gov/oei/reports/OEI-07-21-00251.pdf.
5. An employee of the office of Homeland Security Investigations,
an investigative arm of the U.S. Department of Homeland Security,
stated, ``As the government, we've turned a blind eye to [the]
trafficking [of migrant children].'' \6\ Have you turned a blind eye to
your Department's role in child trafficking?
---------------------------------------------------------------------------
\6\ Hannah Dreier, Alone and Exploited, Migrant Children Work
Brutal Jobs Across the U.S., N.Y. Times (February 28, 2023), https://
www.nytimes.com/2023/02/25/us/unaccompanied-migrant-child-workers-
exploitation.html.
---------------------------------------------------------------------------
I look forward to your prompt and honest response.
Sincerely,
Marsha Blackburn
United States Senator
______
United States Senate
washington, dc 20510
September 20, 2023
The Honorable Xavier Becerra
Secretary
Department of Health and Human Services
Washington, DC 20528
Dear Secretary Becerra:
As I expressed when you appeared before the Senate Finance Committee in
March and again in my letter to you in April, I am appalled by reports
that the Department of Health and Human Services (HHS) has mishandled
unaccompanied minors by placing them with unvetted sponsors, leading to
their exploitation and forced labor.
Your agency's written response to my inquiry, which you did not even
take the time to write yourself, was completely inadequate and an
insult to the duty of oversight entrusted to the United States Senate.
I asked you specifically about your knowledge of this crisis and your
involvement in the alleged whistleblower retaliation that has taken
place under your watch, yet your Assistant Secretary declined to answer
a single question. Additionally, I asked you to provide the documents
you received regarding the potential exploitation of these migrant
children, but Assistant Secretary Hild failed to produce a single
document. Instead, over 5 months later, my inquiry was met with general
information about your failed policies. Your Department's lack of
urgency on this matter, and your continued refusal to provide
information about the amount of time you spent in California instead of
fulfilling your duties in-person, speaks volumes regarding your
mishandling of this crisis.
Democrats on the Senate Judiciary Committee, who refused to call any
government witnesses at a hearing entitled ``Ensuring the Safety and
Well-Being of Unaccompanied Children,'' seem content distracting and
deflecting from this administration's border crisis. In fact, they are
doing anything but ensuring the safety and well-being of these
children, and I will not join them in turning a blind eye to your
negligence. The American people, and the families of the 85,000 migrant
children that this administration lost, deserve answers about your role
in this grave dereliction of duty. I will allow you the opportunity to
respond to the questions I posed in April, and I expect to see you
before the Senate Judiciary Committee as soon as possible.
Please respond to the following questions by September 27, 2023.
1. When did you learn of the mishandling and exploitation of
migrant children who were released by HHS to unvetted sponsors?
2. Are you aware that, under Federal law, it is a crime to
``knowingly and willfully'' make a ``materially false'' statement to
Congress? \1\
---------------------------------------------------------------------------
\1\ 18 U.S.C. Sec. 1001(a)(2).
3. Please provide any reports, correspondence, or other
documentation that you received regarding the potential exploitation of
---------------------------------------------------------------------------
these migrant children.
4. The Department's Office of the Inspector General released a
report indicating that several demotions and dismissals of individuals
who raised concerns about migrant child safety ``may have risen to the
level of whistleblower chilling.'' \2\ Did you personally approve these
demotions and dismissals?
---------------------------------------------------------------------------
\2\ U.S. Department of Health and Human Services, Office of
Inspector General, Operational Challenges Within ORR and the ORR
Emergency Intake Site at Fort Bliss Hindered Case Management for
Children (2023), https://oig.hhs.gov/oei/reports/OEI-07-21-00251.pdf.
5. An employee of the office of Homeland Security Investigations,
an investigative arm of the U.S. Department of Homeland Security,
stated, ``As the government, we've turned a blind eye to [the]
trafficking [of migrant children].'' \3\ Have you turned a blind eye to
your department's role in child trafficking?
---------------------------------------------------------------------------
\3\ Hannah Dreier, Alone and Exploited, Migrant Children Work
Brutal Jobs Across the U.S., N.Y. Times (February 28, 2023), https://
www.nytimes.com/2023/02/25/us/unaccompanied-migrant-child-workers-
exploitation.html.
6. Please provide copies of your schedule, travel expense reports,
and any other relevant documents since the beginning of your tenure as
Secretary that you committed to sharing with Senate Finance Committee
---------------------------------------------------------------------------
members.
I look forward to your personal, prompt, and honest response.
Sincerely,
Marsha Blackburn
United States Senator
______
United States Senate
washington, dc 20510
May 3, 2024
The Honorable Xavier Becerra
Secretary
Department of Health and Human Services
200 Independence Ave., SW
Washington, DC 20201
Dear Secretary Becerra:
I am writing you today to follow-up on the false statements that you
made in your March 14th testimony before the Senate Finance Committee
and to set the record straight. Between fiscal years 2021 and 2023,
over 360,000 unaccompanied children at the southern border were
referred to the custody of the Department of Health and Human Services
(HHS) Office of Refugee Resettlement (ORR).\1\ Disturbingly, your
Department has lost track of over 85,000 of these unaccompanied migrant
children, many of whom have found themselves in dangerous trafficking
rings and forced labor networks.\2\
---------------------------------------------------------------------------
\1\ U.S. Department of Health and Human Services, Office of the
Inspector General, Gaps in Sponsor Screening and Followup Raise Safety
Concerns for Unaccompanied Children (2024), https://oig.hhs.gov/oei/
reports/OEI-07-21-00250.pdf.
\2\ Hannah Dreier, Alone and Exploited, Migrant Children Work
Brutal Jobs Across the U.S., N.Y. Times (February 28, 2023), https://
www.nytimes.com/2023/02/25/us/unaccompanied-migrant-child-workers-
exploitation.html.
At your March 14th appearance before the Senate Finance Committee, I
asked you whether your Department has a responsibility to follow-up
with these unaccompanied children once they have been placed with a
sponsor. To my astonishment, you responded though you and your
colleagues did not give us the authority to follow them after they
---------------------------------------------------------------------------
leave our care.'' But, to put it mildly, the facts indicate otherwise.
Federal law explicitly grants ORR with broad authority to ensure the
well-being and safety of these migrant children, specifically by
``coordinating and implementing'' their care and placement.\3\ ORR is
also tasked with ``implementing policies with respect to care and
placement of unaccompanied alien children.''\4\ Building off of that
broad authority, the reality is that your very own Department has
issued guidance stating that ``care providers must conduct a Safety and
Well Being Follow-up Call with an unaccompanied child and his or her
sponsor 30 days after the release date.'' \5\ That guidance also makes
clear that ``the purpose of the follow-up call is to determine whether
the child is still residing with the sponsor.'' ``If the care provider
believes that the child is unsafe, the care provider must comply with
mandatory reporting laws.'' \6\ Put simply, your Department has failed
to follow its own guidance for the sake of expediency, and you have
tried to shift the blame to Congress.
---------------------------------------------------------------------------
\3\ 6 U.S.C. Sec. 279(b)(1)(A).
\4\ 6 U.S.C. Sec. 279(b)(1)(E).
\5\ ORR Unaccompanied Children Program Policy Guide: Section 2,
Office of Refugee Resettlement, https://www.acf.hhs.gov/orr/policy-
guidance/unaccompanied-children-program
-policy-guide-section-2 (emphasis added).
\6\ Id. (emphasis added).
Your efforts to ensure that these children are safe with their sponsors
have been insufficient, so much so that the HHS Office of the Inspector
General (OIG) released a 62-page report in February 2024 titled ``Gaps
in Sponsor Screening and Followup Raise Safety Concerns for
Unaccompanied Children.'' \7\ In its findings, the OIG report notes
that in 22 percent of cases, ORR did not conduct timely Safety and Well
Being Calls, and in 18 percent of cases, the follow up calls were not
documented in children's case files.\8\ Given these shortcomings, it is
no surprise that the Biden administration has lost track of tens of
thousands of these migrant children.
---------------------------------------------------------------------------
\7\ U.S. Department of Health and Human Services, Office of the
Inspector General, Gaps in Sponsor Screening and Followup Raise Safety
Concerns for Unaccompanied Children (2024), https://oig.hhs.gov/oei/
reports/OEI-07-21-00250.pdf.
\8\ Id.
With President Biden's border crisis continuing to spiral out of
control, I urge you to recognize your direct role in ensuring the well-
being of unaccompanied children entrusted to your care and correct
---------------------------------------------------------------------------
ORR's failures in doing so thus far.
Thank you for your attention to this urgent matter.
Sincerely,
Marsha Blackburn
United States Senator
______
U.S.C. TITLE 6--DOMESTIC SECURITY
Sec. 279. Children's affairs
. . .
(b) Functions
(1) In general
Pursuant to the transfer made by subsection (a), the Director of
the Office of Refugee Resettlement shall be responsible for--
(A) coordinating and implementing the care and placement of
unaccompanied alien children who are in Federal custody by reason
of their immigration status, including developing a plan to be
submitted to Congress on how to ensure that qualified and
independent legal counsel is timely appointed to represent the
interests of each such child, consistent with the law regarding
appointment of counsel that is in effect on November 25, 2002;
. . .
(E) implementing policies with respect to the care and placement of
unaccompanied alien children;
______
ORR Unaccompanied Children Program
Policy Guide: Section 2
Safe and Timely Release from ORR Care
Current as of: April 1, 2024
2.1 Summary of the Safe and Timely Release Process
The Office of Refugee Resettlement (ORR) has policies and procedures in
place to ensure unaccompanied children in ORR care are released in a
safe, efficient, and timely manner. ORR's policies require the release
of unaccompanied children to parents, guardians, relatives, or
individuals designated by the child's parents, referred to as
``sponsors.'' Safe and timely release (also known as ``family
reunification'') must promote public safety and ensure that sponsors
are able to provide for the physical and mental well-being of children.
ORR evaluates potential sponsors' ability to provide for the child's
physical and mental well-being, as required by law. ORR also protects
children from smugglers, traffickers, or others who might seek to
victimize or otherwise engage the child in criminal, harmful or
exploitative activity. The process for the safe and timely release of
an unaccompanied child from ORR custody involves several steps,
including: the identification of sponsors; sponsor application;
interviews; the assessment (evaluation) of sponsor suitability,
including verification of the sponsor's identity and relationship to
the child (if any), background checks, and in some cases home studies;
and post-release planning.
In certain cases, ORR may begin vetting the potential sponsors of
unaccompanied children likely to enter ORR care prior to their physical
transfer to further diminish the time a child would remain in ORR care
(see UC Policy Guide Section 2.2 Sponsor Application Process).
Revised 2/22/24
2.2 Sponsor Application Process
As soon as a child is physically transferred to ORR custody, ORR begins
to assess potential sponsors, which may include interviewing the child,
their parent(s), legal guardian(s), or other primary caregiver(s), in
order to identify family members and others who may be qualify as
sponsors to care for the child. Sponsors may include parents,
relatives, close family friends, or other individuals, and any of these
individuals may apply to have the child released to their care (see UC
Policy Guide Section 2.2.1 Identification of Qualified Sponsors).
In addition, ORR may begin vetting potential sponsors of children
likely to be referred to ORR prior to their physical transfer, where
the Federal agency communicates they will likely be determined to be
unaccompanied children, in response to specific humanitarian missions
and other special operations. In these cases, ORR will not wait for
children to placed in an ORR care provider facility to begin its
reunification process, but will instead follow discrete guidance,
published as Field Guidance (https://www.acf.hhs.gov/orr/policy-
guidance/uc-program-field-guidance), tailored to the requirements and
legal authorities of the specific circumstance.
Revised 2/22/24
2.2.1 Identification of Qualified Sponsors
The ORR care provider (https://www.acf.hhs.gov/orr/policy-guidance/
unaccompanied-children-program-policy-guide-guide-
terms#Care%20Provider), the ORR funded facility that cares for the
child, interviews the child as well as parents, legal guardians, and/or
family members to identify qualified custodians (``sponsors'') (see the
section below on how ORR confirms relationship with child). If a child
is either too young or there are other factors that prohibit the care
provider from obtaining potential sponsor information from the
unaccompanied child, the care provider may seek assistance from the
child's consulate in collaboration with the ORR Federal Field
Specialist (ORR/FFS) or from a reputable family tracing organization.
Finding a sponsor for the child is an ongoing process that continues
during the unaccompanied child's stay in ORR care and custody in the
event that the primary potential sponsor or primary release plan is not
approved.
ORR releases children to a sponsor in the following order of
preference:\1\ parent; legal guardian; an adult relative (brother,
sister, aunt, uncle, grandparent or first cousin); an adult individual
or entity designated by the parent or legal guardian (through a signed
declaration or other document that ORR determines is sufficient to
establish the signatory's parental/guardian relationship); a licensed
program willing to accept legal custody; or an adult individual or
entity seeking custody when it appears that there is no other likely
alternative to long term ORR care and custody. ORR has grouped UC cases
into the following categories.\2\
---------------------------------------------------------------------------
\1\ As per the release order preference outlined in Flores v. Reno
Stipulated Settlement Agreement, No. 85-4544-RJK (Px) (C.D. Cal.,
January 17, 1997).
\2\ These categories were created for program use, to help identify
potential sponsors. They are not intended to replace the legal order of
preference established in Flores.
Category 1: Parent or legal guardian. This includes qualifying
---------------------------------------------------------------------------
step-parents that have legal or joint custody of the child or teen.
Category 2A: A brother; sister; grandparent or other immediate
relatives (e.g., aunt, uncle, first cousin) who previously served as
the UC's primary caregiver. This includes biological relatives,
relatives through legal marriage, and half-
siblings.
Category 2B: An immediate relative (e.g., aunt, uncle, first
cousin) who was not previously the UC's primary caregiver. This
includes biological relatives, relatives through legal marriage.
Category 3: Other sponsor, such as distant relatives and
unrelated adult individuals.
Category 4: No sponsor identified.
Although ORR gives preference to a parent or legal guardian when
determining release plans, there are instances when ORR does not
release an unaccompanied child to a parent or legal guardian. These
include:
There has been a court ordered termination of parental rights
over the child.
There is substantial evidence that the child would be at risk of
harm if released to the parent or legal guardian.
In some cases, a UC enters the United States with their biological
child. In those cases, ORR identifies a sponsor for the UC as well as
for the infant or toddler. In most instances, it is in the best
interest of the UC and the biological child to be released to the same
sponsor. In cases where the relationship between the UC parent and the
sponsor and the infant and the sponsor fall under different sponsor
categories, ORR assigns the sponsor category representing the closer
relationship in the infant's case. For example, if the relationship
between the UC parent and the sponsor falls under Category 2A and the
relationship between the sponsor and infant falls under Category 3,
then category assigned in the infant's case would be Category 2A.
Revised 03/8/2022
2.2.2 Contacting Potential Sponsors
The child's care provider is responsible for implementing safe
screening methods when contacting and communicating with potential
sponsors. These methods are to ensure that a potential sponsor does not
pose a risk to the unaccompanied child, to other children in the care
provider facility or to care provider staff.
Safe screening methods include:
Use of appropriate interpreters
Proof of sponsor's identity is obtained
Verification of family relationships
Coordination with the unaccompanied child's parents, legal
guardians, or closest relatives prior to contacting non-relative adult
potential sponsors
Screening for exploitation, abuse, trafficking, or other safety
concerns
Engaging the child to communicate openly with care provider
staff about their own sense of safety
Effective 02/13/24
2.2.3 The Family Reunification Application
All potential sponsors must complete an application in order for a
child to be released to them from ORR custody (the ``Family
Reunification Application'').
Within 24 hours of identification of a potential sponsor for a child or
youth, the care provider or the ORR National Call Center sends the
sponsor a package with the application and related documents (called
the Family Reunification Packet or FRP).
The application package includes the following documents:
Family Reunification Packet Cover Letter
Authorization for Release of Information
Family Reunification Application (FRA)
Sponsor Care Agreement
A flyer with contact information on organizations offering a
Legal Orientation Program for Custodians (LOPC)
A flyer with contact information for the UC Sexual Abuse Hotline
Fingerprint instructions
Sponsor Handbook
Letter of Designation for Care of a Minor (If parent or legal
guardian wishes to specify)
A flyer warning sponsors of potential fraud schemes
The care provider is available to help the potential sponsor complete
the application. ORR may require certain sponsors to fill out the FRA
and other documents based on concerns related to safety, including
sponsor motivation. ORR may in its discretion require the sponsor to
submit their own FRA if there has been a safety concern identified that
indicates that the sponsor should file the FRA without the case
manager's assistance OR if the sponsor indicates that they prefer to
submit the FRA by themselves.
The care provider case manager or other care provider staff or
volunteer may assist the sponsor by filling out the FRA with a sponsor
over the phone.
The case manager or other care provider staff or volunteer must read
the attestation of perjury that is found in the FRA to the sponsor. The
completed FRA is sent to the sponsor for verification. Sponsors must
verify and sign the FRA and submit back to the case manager with any
corrections. Copies, including photographs, and/or electronic
signatures are accepted.
Revised 03/8/22
2.2.4 Required Documents for Submission with the Application for
Release
In addition to completing and signing the Family Reunification
Application (FRA) and the Authorization for Release of Information
(ARI), potential sponsors must provide documentation of identity,
address, and relationship to the child they seek to sponsor.\3\
Potential sponsors must also submit documentation verifying the
identity of the children they seek to sponsor, and evidence verifying
the identity of all adults residing with the sponsor and all adult
caregivers identified in a sponsor care plan. In addition to their use
as evidence of the foregoing, all documentation submitted under this
section is used as part of the overall sponsor assessment process. See
Section 2.4 Sponsor Assessment Criteria and Home Studies. As a result,
ORR may in its discretion require potential sponsors to submit
additional documentation beyond the minimums specified below.
---------------------------------------------------------------------------
\3\ The care provider may offer assistance to potential sponsors in
securing necessary documentation, but it is ultimately the potential
sponsor's responsibility to find and submit them.
---------------------------------------------------------------------------
Proof of Sponsor Identity
To verify their identity, all potential sponsors must submit original
versions or legible copies of government-issued identification
documents. They may present either one selection from List A or two or
more documents from List B. If a potential sponsor presents selections
from list B, at least one selection must contain a legible photograph.
Expired documents are acceptable for the purpose of establishing
identity.
LIST OF ACCEPTABLE DOCUMENTS
_______________________________________________________________________
LIST A
U.S. Passport or U.S. Passport Card
Permanent Resident Card or Alien Registration Receipt Card (Form I-551)
Foreign Passport that contains a photograph
Employment Authorization Document that contains a photograph (Form I-
766)
U.S. Driver's License or Identification Card
_______________________________________________________________________
OR
_______________________________________________________________________
LIST B
U.S. Certificate of Naturalization
U.S. Military Identification Card
Birth Certificate
Marriage Certificate
Court order for name change
Foreign national identification card
Consular passport renewal receipt that contains a photograph
Mexican consular identification card
Foreign driver's license that contains a photograph
Foreign voter registration card that contains a photograph
Canadian border crossing card that contains a photograph
Mexican border crossing card that contains a photograph with valid Form
I-94
Refugee travel document that contains a photograph
Foreign driver's license that contains a photograph
Other similar documents (includes ORR Verification of Release form with
a photograph for individuals under the age of 21\4\
---------------------------------------------------------------------------
\4\ Potential sponsors, adult household members, and adult
caregivers identified in a sponsor care plan may submit an original
version or legible copy of an ORR Verification of Release form, but
only to verify the identity of adults under the age of 21, and only if
the form contains a photograph. ORR will not accept a Verification of
Release as proof of identity if it does not contain a photograph and/or
is for anyone 21 and older.
---------------------------------------------------------------------------
_______________________________________________________________________
Proof of identify of adult household members and adult caregivers
identified in a sponsor care plan
As a general matter, ORR prioritizes the placement of unaccompanied
children with parents and legal guardians available to provide care and
custody in the United States (i.e., Category 1 sponsors). Where there
are no safety concerns, ORR does not require proof of identify for
household members and adult caregivers of Category 1 sponsors, so long
as:
The child is not determined to be especially vulnerable through
ORR's screening and assessment process;
The child is not subject to a mandatory Trafficking Victims
Reauthorization Act (TVPRA) home study (See Section 2.4.2 Home Study
Requirement); and
There are no other safety concerns present in the case,
including relating to abuse or neglect.
When an individual is simultaneously sponsoring multiple closely
related children for whom they would be a Category 1 and Category 2A or
Category 2B sponsor, the proof of identity for HHM and adult caregiver
is not required so long as there are no safety concerns as described
above. All other potential sponsors that do not meet the criteria above
must submit documentation verifying the identity of non-sponsor adults
in their household and adult caregivers named in the sponsor care plan.
Potential sponsors must submit at least one identification document
that contains a photograph for all such adults. The document may be
from either List A or List B above and may be an original version or a
legible copy of the document. Expired documents are acceptable for the
purpose of establishing identity.
Proof of Address
All potential sponsors must submit at least one form of documentation
verifying their current address. Acceptable forms of documentation
include original versions or legible copies of:
A current lease or mortgage statement dated within the last 2
months before submission of the FRA;
A valid, unexpired State ID with current address and photo;
A utility bill, addressed in the sponsor's name and dated within
the last 2 months before submission of the FRA;
A bank statement dated within the last 2 months before
submission of the FRA;
A payroll check stub issued by an employer, dated within the
last 2 months before submission of the FRA;
A piece of mail from a county, State, or Federal agency (with
the exception of ORR) with the sponsor's name and residential address
and dated within the last 2 months before submission of the FRA;
A notarized letter from a landlord on the business stationary of
the real property owner confirming the sponsor's address; and
Other similar documents reliably indicating that the sponsor
resides at the claimed address, dated within the last 2 months before
submission of the FRA.
ORR may use alternative methods to verify address. For example, ORR may
send a letter containing specific instructions to the address given by
the sponsor and provide a timeline by which the sponsor must comply
with the instructions.
Proof of Child's Identity
The potential sponsor or child's family must provide the unaccompanied
child's birth certificate or a legible copy of the child's birth
certificate.
Proof of Sponsor-Child Relationship
The potential sponsor must provide at least one form of evidence
verifying the relationship claimed with the child.\5\ Acceptable
documents include original versions or legible copies of:
---------------------------------------------------------------------------
\5\ Verification of the potential sponsor's relationship to the
child is a minimum step required by the TVPRA to determine a potential
sponsor's suitability and capability of providing for the child's
physical and mental well-being. See 8 U.S.C. Sec. 1232. As a result, as
stated above, ORR may in its discretion require the submission of
multiple forms of evidence.
---------------------------------------------------------------------------
Birth certificates;
Marriage certificates;
Death certificates;
Court records;
Guardianship records;
Hospital records;
School records;
Written affirmation of relationship from Consulate; and/or
Other similar documents.
Category 2A potential sponsors providing evidence of ``primary
caregiver''
Category 2A sponsors who are not grandparents or adult siblings must
prove they are or were the child's primary caregiver. A primary
caregiver is defined as any person who is primarily entrusted with the
child's care and who lives with the child.
If the potential sponsor has any guardianship documents or other
documents from a state or foreign government, they must submit this
with the Family Reunification Application. ORR also accepts sworn
affidavits from potential sponsors in addition to corroborating
interviews the case manager has with the child, potential sponsor, and
other family members to establish whether the potential sponsor was a
primary caregiver to the child.
Category 3 potential sponsors without a bona fide pre-existing
relationship
Category 3 potential sponsors who are unable to provide verifiable
documentation of a familial relationship with the unaccompanied child
must submit evidence that reliably and sufficiently demonstrates a bona
fide social relationship with the child and/or the child's family that
existed before the child migrated to the United States. Care providers
must attain sufficient corroboration to be confident that they have
received needed verification of the relationship between the potential
sponsor and the child or child's family.
If a Category 3 potential sponsor does not submit evidence that
reliably and sufficiently demonstrates a bona fide preexisting social
relationship between the potential Category 3 sponsor and the child
and/or the child's family, ORR may take this into account when
determining the suitability of the case for release. In such cases ORR
may require that the potential Category 3 sponsor, the child, and the
child's family, establish ongoing regular contact while the child is in
ORR care, prior to a release recommendation.
Criminal History
If a potential sponsor has been charged with or convicted of any crime
or investigated for the physical abuse, sexual abuse, neglect, or
abandonment of a child, they must provide related court records and
police records, as well as governmental social service records or proof
of rehabilitation related to the incident where there has been a
substantiated finding or a conviction.
Fraud
If a sponsor, household member, or adult caregiver provides any false
information in the application of release and/or accompanying documents
or submits fraudulent documents for the purposes of obtaining
sponsorship of the child, ORR will report the incident to HHS/Office of
the Inspector General (OIG). Fraudulent documents include documents on
which the address, identity, or other relevant information is false or
documents that have been manufactured or altered without lawful
authorization. ORR may deny release if it is determined that fraudulent
documents were submitted during the application of release process.
Effective 02/13/24
2.2.5 Legal Orientation Program for Custodians
All potential sponsors of children and youth under the care of ORR
should attend a presentation provided by the Legal Orientation Program
for Custodians (LOPC). The purpose of this program is to inform
potential sponsors of their responsibilities in ensuring the child's
appearance at all immigration proceedings, as well as protecting the
child from mistreatment, exploitation, and trafficking, as provided
under the Trafficking Victims Protection Reauthorization Act of 2008.
The program also provides information about possible free legal counsel
(pro bono legal services) for the youth or child during the immigration
court process.
The Office of Legal Access Programs (OLAP), within the Executive Office
for Immigration Review (EOIR) at the U.S. Department of Justice,
manages the LOPC and contracts with legal service organizations around
the country to provide LOPC services to potential sponsors in their
local communities or in metropolitan areas served by the program. EOIR
is the entity in the Federal Government that is also responsible for
adjudicating immigration cases by fairly, expeditiously, and uniformly
interpreting and administering the nation's immigration laws.
The unaccompanied child's case manager is responsible for informing
potential sponsors about all procedures related to the child's case--
including attendance at an LOPC presentation. The Family Reunification
Packet (FRP) that goes to each potential sponsor includes an
Authorization for Release of Information that the sponsor must sign
before the case manager may schedule an appointment for LOPC services.
All potential sponsors should submit the Authorization for Release of
Information immediately and prior to submitting the complete FRP to
ensure timely scheduling of their LOPC session.
Upon receipt of the Authorization, the case manager schedules an
appointment for a potential sponsor to attend a presentation with one
of the LOPC providers around the country. Alternatively, the case
manager contacts the LOPC National Call Center at (888) 996-3848 and
arranges for the Call Center to schedule an LOPC appointment for the
potential sponsor or mail an LOPC Information Packet to the sponsor.
When evaluating family members and other potential sponsors, ORR
considers whether they have attended an LOPC presentation. Attendance
at an LOPC presentation is a factor in the release assessment.
Revised 12/4/17
2.2.6 Additional Questions and Answers about this Topic
Q: Will sponsors receive the Family Reunification Packet through the
mail or electronically?
A: Case managers will work with sponsors to identify the best way to
get the packets to them, whether electronically or by fax transmission
or postage paid overnight mail.
Q: Do sponsors need assistance from an attorney or a paid
representative to complete the packet?
A: No. The unaccompanied child's case manager will be able to help the
potential sponsor complete the form and explain the process.
Q: Is it possible for an unaccompanied child's spouse to be a sponsor?
A: ORR considers release to an unaccompanied child's adult spouse on a
case by case basis.
Q: Is it possible for family members in the United States to
proactively contact ORR about children who may have entered the country
unaccompanied?
A: Yes. Family members may call the ORR National Call Center, at (800)
203-7001.
Posted 01/27/15
2.3 Key Participants in the Release Process
ORR's sponsor assessment and release decision process requires
coordination among care provider staff, nongovernmental third-party
reviewers (Case Coordinators), ORR staff, other Federal agencies,
stakeholders, and Child Advocates, where applicable.
Case Managers communicate with potential sponsors, gather necessary
information and documentation, talk to any relevant stakeholders, and
assess sponsors to formulate a recommendation to the Case Coordinator.
Case Coordinators concurrently review all assessment information on an
unaccompanied child and sponsor to also make a recommendation. Once
Case Managers and Case Coordinators agree on a particular
recommendation for release, the ORR/FFS makes a final release decision.
If the Case Manager and Case Coordinator cannot agree on a
recommendation, the case is elevated to the ORR/FFS for further
guidance.
Revised 06/18/19
2.3.1 ORR/Federal Field Specialists (ORR/FFS)
ORR/FFS are ORR's field staff located regionally throughout the country
and are assigned to a group of care providers within a particular
geographic region. ORR has final authority on transfer and release
decisions. ORR/FFS act as agents of HHS/ORR to approve all
unaccompanied children transfer and release requests. In addition, ORR/
FFS have authority to oversee care providers to ensure all services are
properly provided and implemented and serve as a local liaison to
community stakeholders, including other Federal agencies, local legal
service providers, communities, Child Advocates, etc. ORR/FFS also
provide guidance, direction, and technical assistance to care
providers.
Acting as agents of HHS/ORR, ORR/FFS also make final decisions as to
whether home studies are conducted and/or post-release services are
provided.\6\ ORR/FFS coordinate all aspects of a child's case with care
provider staff, Case Coordinators, stakeholders, and other Federal
agencies.
---------------------------------------------------------------------------
\6\ The ORR Director delegates final authority for approving
discretionary home studies to ORR/FFS Supervisors who act as agents of
HHS/ORR. (See Section 2.4.2).
---------------------------------------------------------------------------
Revised 03/28/23
2.3.2 Case Managers
Care provider case managers perform a variety of duties, including
coordinating the completion of assessments of unaccompanied children,
completing individual service plans, assessing potential sponsors,
making transfer and release recommendations, and coordinating the
release of a child or youth from ORR care and custody. Care providers
are required to provide case management services, at minimum, during
normal business hours. ORR may also require care providers to extend
service hours to evenings and weekends (e.g., requiring availability of
case management services 7 days a week, including holidays, 8 am
through 10 pm local time). The care provider also provides a range of
services through other trained staff that are described in Section 3:
Services (https://www.acf.hhs.gov/orr/policy-guidance/unaccompanied-
children-program-policy-guide-section-3).
The role of the case manager within the release process is to initiate
and maintain ongoing communication with the potential sponsor, gather
sponsor information, and assess whether the potential sponsor is a
suitable sponsor who can safely provide for the physical and mental
well-being of the child or youth. When communicating with the potential
sponsor, the case manager:
Provides direct assistance on completing the sponsor application
packet and ensuring provision of supporting documentation;
Involves the sponsor in making a plan for individualized
services for the child, as appropriate;
Keeps the sponsor informed of the child's progress and current
functioning;
Provides the sponsor with detailed information about the child's
needs in order to fully assess the sponsor's ability to provide care
and services, including completing a sponsor care plan, when necessary;
Discusses services that are available in the sponsor's community
for the child; and
Shares relevant information on the UC in accordance with
applicable privacy and information-sharing policies, including policy
related to a child's pregnancy or abortion decision as found in Policy
Memorandum: Medical Services Requiring Heightened ORR Involvement
(https://www.acf.hhs.gov/sites/default/files/documents/orr/
garza_policy_memorandum.pdf), and in collaboration with the UC and the
child's clinician in a way that best serves the child's safety and
well-being.
The case manager's role is also to ensure that information is gathered
or shared with the appropriate staff and stakeholders during the
sponsor assessment process. The case manager participates in weekly
case management staffings with the child's assigned case coordinator
and ORR/FFS on the progress in achieving a safe and timely release with
family members as well as potential challenges that may delay a
release. The Child Advocate may attend case staffings, at the request
of the FFS. Case management staffings may occur monthly for children in
LTFC if they are not being considered for reunification to a sponsor.
The case manager provides weekly status updates (monthly for children
in LTFC if they are not being considered for reunification to a
sponsor) to the child on the child's case and provision of services,
preferably in person. The child may have their attorney of record and
Child Advocate present for these case management updates, if
applicable.
The case manager provides legal service providers (LSPs), attorneys of
record, and Child Advocates, if applicable, of the progress of a
child's case on a weekly basis on case management decisions, which
includes the following:
Notification that a child may not have a potential sponsor,
Change in sponsor categories,
Any final release decisions, and
When a child has been recommended for, has initiated, or is
pending transfer to a different level of care (specifically long-term
foster care), and when a child's transfer request has been approved.
LSP and attorneys of record information requests for a child's case
file information beyond these updates must go through the established
case file request process in Section 5.10.1 UC Case File Request
Process (https://www.acf.hhs.gov/orr/policy-guidance/unaccompanied-
children-program-policy-guide-section-5#5.10.1).
Case managers may share case information with ORR post-release and home
study providers and Unaccompanied Refugee Minors (URM) providers if a
child is being referred for those services.
Revised 08/07/2023
2.3.3 Case Coordinators
Case Coordinators are non-governmental contractor field staff assigned
to one or more care providers primarily to review unaccompanied
children cases and provide transfer and release recommendations to ORR
staff. The Case Coordinator is responsible for integrating all areas of
assessment from the Case Manager, Child Advocates, where applicable,
and other stakeholders into a release plan that will provide for the
unaccompanied child's physical and mental well-being. After staffing
and reviewing a case, Case Coordinators and Case Managers must agree on
a release recommendation. If there is a disagreement or a particularly
complex case, then the case will be elevated to the ORR/FFS for further
guidance.
Providing timely review and assessment of potential sponsors and
unaccompanied children to make recommendations for release to ORR in
conjunction with the Case Manager;
Assisting ORR in ensuring that children are placed in the least
restrictive setting while receiving all appropriate services;
Meeting with individual unaccompanied children and care provider
staff at designated ORR-funded care provider sites;
Providing targeted child welfare-based assistance to care
provider staff, as directed by ORR staff;
Making recommendations for home study and post-release services
for at-risk children;
Making placement recommendations for children who require more
specialized levels of care, such as long-term foster care and
residential treatment centers;
Participating in collaborative meetings with local stakeholders;
and
Participating in staffing of cases with care providers and
designated ORR staff.
Revised 08/1/16
2.3.4 Child Advocates
ORR may appoint Child Advocates for victims of trafficking and other
vulnerable children. Child Advocates are third parties who make
independent recommendations regarding the best interests of a child.
Their recommendations are based on information that is obtained from
the child and other sources (e.g., the child's parents, potential
sponsors, government agencies, and other stakeholders). Child Advocates
formally submit their recommendations to ORR and/or the immigration
court in the form of Best Interest Determinations (BIDs). ORR considers
BIDs when making decisions regarding the care, placement, and release
of unaccompanied children, but it is not bound to follow BID
recommendations.
As required by the TVPRA, ORR provides Child Advocates with access to
information necessary to effectively advocate for the best interests of
children with whom they are working. After providing proof of
appointment, Child Advocates have access both to their clients and to
their clients' records. Child Advocates may access their clients'
entire original case files at care provider facilities, or request
copies from care providers. Child advocates must keep the information
in the case file, and information about the child's case, confidential
from non-ORR grantees, contractors, and Federal staff. Further, they
may participate in case staffings.\7\
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\7\ Child advocates must keep the information in the case file, and
information about the child's case, confidential from non-ORR grantees,
contractors, and Federal staff.
Child Advocates and ORR maintain regular communication, informing each
other of considerations or updates that impact service provision and
---------------------------------------------------------------------------
release planning.
Child Advocates' duties include:
Client Visits: The Child Advocate meets with the unaccompanied
child regularly and speaks with the child's care provider staff in
order to understand the child's background and current situation.
Decision Making: The Child Advocate helps the unaccompanied
child understand legal and care-related issues, explains the
consequences of decisions made in response to those issues, and assists
the child in making decisions when the child requests such help.
Best Interests Advocacy: The Child Advocate develops a service
plan containing best-interest recommendations with respect to the care,
placement, and release options; and keeps the care provider, ORR, and
the legal service provider or attorney of record apprised of the plan
and advocacy efforts.
Case updates: The Child Advocate collaborates and regularly
communicates with the care provider, ORR, and other stakeholders in the
planning and performance of advocacy efforts. For children who have
been released from ORR care, Child Advocates provide timely updates as
appropriate or as requested by ORR.
In most cases, ORR appoints Child Advocates while children are in its
custody. However, in its discretion, ORR may appoint Child Advocates
for unaccompanied children after their release from ORR care.
Revised 08/07/2023
2.4 Sponsor Assessment Criteria and Home Studies
As noted in the Section 2.2 Application for Safe and Timely Release of
an Unaccompanied Child from ORR Care, the application process for
release of an unaccompanied child involves a number of steps, including
background checks (see Section 2.5 ORR Policies on Requesting
Background Checks) and submission of the application by the sponsor.
This section describes the criteria ORR uses to assess each potential
sponsor's ability to provide for the physical and mental well-being of
the unaccompanied child, and the role of home studies in the process.
The sponsor assessment reviews a sponsor's strengths, resources, risk
factors and special concerns within the context of the unaccompanied
child's needs, strengths, risk factors, and relationship to the
sponsor.
ORR also determines whether to conduct a home study, as required by the
law or as necessary to ensure the welfare of the child.
Revised 03/15/16
2.4.1 Assessment Criteria
ORR considers the following factors when evaluating family members and
other potential sponsors:
The nature and extent of the sponsor's previous and current
relationship with the child or youth and the unaccompanied child's
family, if a relationship exists.
The sponsor's motivation for wanting to sponsor the child or
youth.
The unaccompanied child's parent or legal guardian's perspective
on the release to the identified potential sponsor (for cases in which
the parent or legal guardian has designated a sponsor).
The child or youth's views on the release and whether he or she
wants to be released to the individual.
The sponsor's understanding of the unaccompanied child's needs,
as identified by ORR and the care provider.
The sponsor's plan to provide adequate care, supervision, access
to community resources, and housing.
The sponsor's ability to provide the child with a stable home
environment and a sense of permanency, to include whether the sponsor
has an outstanding order of removal.
The sponsor's understanding of the importance of ensuring the
unaccompanied child's presence at all future hearings or proceedings,
including immigration court proceedings, and the sponsor's attendance
at a Legal Orientation Program for Custodians (LOPC) presentation. See
Section 2.2.5 Legal Orientation Program for Custodians.
The linguistic and cultural background of the child or youth and
the sponsor, including cultural, social, and communal norms and
practices for the care of children.
The sponsor's strengths, resources, and mitigating factors in
relation to any risks or special concerns of the child or sponsor, such
as a criminal background, history of substance abuse, mental health
issues, or domestic violence and child welfare concerns.
The unaccompanied child's current functioning and strengths in
relation to any risk factors or special concerns, such as children or
youth who are victims of human trafficking; are a parent or are
pregnant; have special needs, disabilities or medical or mental health
issues; have a history of criminal, juvenile justice, or gang
involvement; or a history of behavioral issues.
Revised 01/30/23
2.4.2 Home Study Requirement
The care provider screens each case to determine whether to recommend a
home study of the potential sponsor as required under the Trafficking
Victims Protection Reauthorization Act of 2008 (TVPRA) (https://
www.govinfo.gov/content/pkg/BILLS-110hr7311enr/pdf/BILLS-
110hr7311enr.pdf) (as codified at 8 U.S.C. Sec. 1232(c)(3)(B)) or ORR's
policy. Information about the child is collected during initial
placement into an ORR facility and throughout their stay. The care
provider then uses the information collected about and from the child
and sponsor to determine whether to conduct a home study.
TVPRA Mandatory Home Studies
The TVPRA requires home studies in the following circumstances:
1. The child is a victim of a severe form of trafficking in
persons;
2. The child is a special needs child with a disability as defined
by the Americans with Disabilities Act of 1990, as amended (42 U.S.C.
Sec. 12102);
3. The child has been a victim of physical or sexual abuse under
circumstances that indicate that the child's health or welfare has been
significantly harmed or threatened; or
4. The child's sponsor clearly presents a risk of abuse,
maltreatment, exploitation, or trafficking, to the child based on all
available objective evidence.
ORR Mandated Home Studies
ORR requires a home study before releasing any child to a sponsor in
the following circumstances:
1. The potential sponsor is seeking to concurrently sponsor two or
more children (regardless of whether the potential sponsor has
previously sponsored or sought to sponsor a child) and at least one of
the children is unrelated to the potential sponsor;
2. The potential sponsor has previously been the sponsor of two or
more children and is now seeking to sponsor one or more additional
children (regardless of whether the previous or current children are
related to the potential sponsor); or
3. The potential sponsor is seeking to sponsor an unrelated child
who is 12 years or under.
DISCRETIONARY HOME STUDIES
In circumstances in which a home study is not required by the TVPRA or
ORR policy, the case manager, and case coordinator may recommend that a
home study be conducted if they agree that the home study may provide
additional information to determine that the sponsor is able to care
for the health, safety and well-being of the child. See Footnote 6.
The care provider must inform the potential sponsor whenever a home
study is conducted, explain the scope and purpose of the study and
answer the potential sponsor's questions about the process. In
addition, the care provider must provide the home study report to the
potential sponsor if the release request is denied. See also UC Policy
Guide Section 2.7.7, Notification of Denial.
Home Study Report and Final Recommendation
The purpose of a home study is to:
1. Assess the potential sponsor's ability to meet the child's
needs,
2. Educate and prepare the potential sponsor for the child's
release; and
3. Corroborate information gathered on the sponsor assessment.
A home study consists of interviews, a home visit, and a written report
containing the home study case worker's findings.
The final recommendation must present a comprehensive and detailed
assessment of the sponsor's ability to care for the needs of the child
and identify any information that emerges regarding the sponsor, the
sponsor's household or the child. This may include information that
raises child welfare concerns. The home study report may identify areas
where additional services, resources, or information are needed to
support a successful sponsorship. The home study provider makes a
recommendation to ORR about release to the sponsor. The ORR/FFS takes
the home study provider's recommendation into consideration when making
a release decision. ORR has final authority on release decisions. ORR/
FFS acts as agents of HHS/ORR to approve all unaccompanied children
release requests.
The home study provider must accept the home study referral from ORR
and staff the case with a case manager within three (3) calendar days
of ORR's referral. The home study provider must contact the care
provider within 24 hours of home study referral acceptance and contact
the sponsor to schedule the home visit within 48 hours of referral
acceptance.
The home study provider conducts the home visit in person. In
exceptional circumstances, where conducting the visit virtually would
be in the best interest of the child, the home study provider may
request ORR's case-by-case approval to conduct a virtual visit. The
home study provider submits the written report within 10 calendar days
of receipt of the referral. Any requests by the home study provider to
extend beyond 10 calendar days or to cancel a home study must be
submitted in writing to the ORR/FFS for consideration.
All releases following home studies require post-release services.
If the case manager learns new information that raises child welfare
concerns after the home study provider has submitted their final
report, the ORR/FFS has the authority to request a home study addendum
from the original home study provider to gather more information for an
informed release decision. The FFS may request an addendum any time
after the final home study report has been submitted, but in some
circumstances, it may be necessary to request a new home study if the
sponsor's circumstances have significantly changed or if the home study
was completed over a year prior to the current date. Home studies are
only valid for 1 year.
Must a child receive a Trafficking Eligibility or Interim Assistance
Letter from HHS prior to being referred for a
TVPRA-mandated home study under #1 above?
No, a child does not need to receive a Trafficking Eligibility Letter
from HHS prior to being referred for a home study. A care provider may
refer a child for a home study under #1 above if, during the assessment
for trafficking, the care provider determines the child is a victim of
a severe form of trafficking in persons.
In determining whether a TVPRA-mandated home study is required under #3
above, care providers consider the following questions:
What is physical abuse?
Physical abuse is an act that results in physical injury, such as red
marks, cuts, welts, bruises, broken bones, missing or broken teeth or
muscle strains. Acts of physical abuse include but are not limited to
punching, beating, kicking, biting, hitting (with a hand, stick, strap,
or other object), burning, strangling, whipping, or the unnecessary use
of physical restraint.
Is physical abuse intentional?
Generally, physical abuse is intentional; however, physical abuse can
occur when physical punishment goes too far. In other words, an
accidental injury of a child may be considered physical abuse if the
act that injured the child was done intentionally as a form of
punishment.
Must a child have physical injuries to meet the standard for physical
abuse under #3?
No, in some cases, a child may not have physical injuries at the time
the care provider makes an assessment. Children may be in various
stages of the healing process or thoroughly healed from the physical
abuse by the time they arrive in ORR care.
For the purposes of #3, who can physically or sexually abuse a child?
A parent, legal guardian, caregiver or other adult with a special
relationship to the child can physically or sexually abuse a child.
Who is considered to be a caregiver or adult with a special
relationship?
A caregiver is defined as any person who is entrusted with the child's
care and who lives with the child. Other adults with a special
relationship to the child could include a teacher, priest, or health-
care provider.
What is sexual abuse?
Sexual abuse of a child by a parent, legal guardian, caregiver or other
adult with a special relationship to the child includes any of the
following acts, with or without the consent of the child or youth:
Contact between the penis and the vulva or the penis and the
anus, including penetration, however slight;
Contact between the mouth and the penis, vulva, or anus;
Contact between the mouth and any body part where the adult has
the intent to abuse, arouse, or gratify sexual desire;
Penetration of the anal or genital opening, however slight, by a
hand, finger, object, or other instrument where the adult has the
intent to abuse, arouse, or gratify sexual desire;
Any other intentional contact, either directly or through the
clothing, of or with the genitalia, anus, groin, breast, inner thigh,
or the buttocks where the intent is to abuse, arouse, or gratify sexual
desire;
Any attempt, threat, or request by the adult to engage in the
activities described above;
Any display by the adult of his or her uncovered genitalia,
buttocks, or breast in the presence of the child; and
Voyeurism.
State laws on statutory rape are not the standard in assessing whether
a youth has been sexually abused for the purposes of #3. Care providers
use the definition from the ORR rule concerning sexual abuse and
harassment; however, for the purposes of determining when a home study
is required, the perpetrator is limited to a parent, legal guardian,
caregiver, or other adult with a special relationship to the child.
Under what circumstances is a child's health or welfare considered to
have been significantly harmed or threatened?
Care providers assess the totality of the circumstances in determining
whether a child's health or welfare has been significantly harmed or
threatened. In evaluating a specific case, care providers take into
consideration not only the definitions of physical and sexual abuse
listed above, but also the circumstances surrounding the incident and
any behaviors that the child or youth exhibits as a result of the
abuse. Circumstances to consider include but are not limited to: the
amount of time that has passed since the abuse, the period of time in
which the abuse occurred, the cultural context in which the abuse
occurred, the age of the child or youth at the time of the abuse, and
the relationship between the youth and the perpetrator.
Care providers take into consideration the situations and behaviors
listed below, but do not make a determination based solely on the
presence or absence of one of them.
The child experiences on-going medical issues from physical
injuries.
The child exhibits negative or harmful behaviors, thoughts or
emotions, such as, but not limited to, excessive hostility or
aggression towards others, fire setting, cutting, depression, eating
disorders suicidal ideation or substance abuse.
In evaluating difficult cases, the care provider should consult with
their ORR/FFS.
Effective 02/13/24
2.4.3 Additional Questions and Answers on This Topic
Q: What happens if a new sponsor is identified during the sponsor
assessment process?
A: If there are multiple potential sponsors, the ORR-funded care
provider will exhaust all efforts to facilitate a release to a parent
or legal guardian while also contacting and evaluating other potential
sponsors concurrently. ORR has release order preferences and will
evaluate sponsors concurrently in accordance with the preference orders
to determine the best placement for the child.
Q: Must a child receive a Trafficking Eligibility or Interim Assistance
Letter from HHS prior to being referred for a TVPRA-mandated home study
under #1 above?
A: No, a child does not need to receive a Trafficking Eligibility
Letter from HHS prior to being referred for a home study. A care
provider may refer a child for a home study under #1 above if, during
the assessment for trafficking, the care provider determines the child
is a victim of a severe form of trafficking in persons.
In determining whether a TVPRA-mandated home study is required under #3
above, care providers consider the following questions:
Q: What is physical abuse?
A: Physical abuse is an act that results in physical injury, such as
red marks, cuts, welts, bruises, broken bones, missing or broken teeth
or muscle strains. Acts of physical abuse include but are not limited
to punching, beating, kicking, biting, hitting (with a hand, stick,
strap or other object), burning, strangling, whipping, or the
unnecessary use of physical restraint.
Q: Is physical abuse intentional?
A: Generally, physical abuse is intentional; however, physical abuse
can occur when physical punishment goes too far. In other words, an
accidental injury of a child may be considered physical abuse if the
act that injured the child was done intentionally as a form of
punishment.
Q: Must a child have physical injuries to meet the standard for
physical abuse under #3?
A: No, in some cases, a child may not have physical injuries at the
time the care provider makes an assessment. Children may be in various
stages of the healing process or thoroughly healed from the physical
abuse by the time they arrive in ORR care.
Q: For the purposes of #3, who can physically or sexually abuse a
child?
A: A parent, legal guardian, caregiver or other adult with a special
relationship to the child can physically or sexually abuse a child.
Q: Who is considered to be a caregiver or adult with a special
relationship?
A: A caregiver is defined as any person who is entrusted with the
child's care and who lives with the child. Other adults with a special
relationship to the child could include a teacher, priest, or health
care provider.
Q: What is sexual abuse?
A: Sexual abuse of a child by a parent, legal guardian, caregiver, or
other adult with a special relationship to the child includes any of
the following acts, with or without the consent of the child or youth:
Contact between the penis and the vulva or the penis and the
anus, including penetration, however slight;
Contact between the mouth and the penis, vulva, or anus;
Contact between the mouth and any body part where the adult has
the intent to abuse, arouse, or gratify sexual desire;
Penetration of the anal or genital opening, however slight, by a
hand, finger, object, or other instrument where the adult has the
intent to abuse, arouse, or gratify sexual desire;
Any other intentional contact, either directly or through the
clothing, of or with the genitalia, anus, groin, breast, inner thigh,
or the buttocks where the intent is to abuse, arouse, or gratify sexual
desire;
Any attempt, threat, or request by the adult to engage in the
activities described above;
Any display by the adult of his or her uncovered genitalia,
buttocks, or breast in the presence of the child; and
Voyeurism.
State laws on statutory rape are not the standard in assessing whether
a youth has been sexually abused for the purposes of #3. Care providers
use the definition from the ORR rule concerning sexual abuse and
harassment; however, for the purposes of determining when a home study
is required, the perpetrator is limited to a parent, legal guardian,
caregiver, or other adult with a special relationship to the child.
Q: Under what circumstances is a child's health or welfare considered
to have been significantly harmed or threatened?
A: Care providers assess the totality of the circumstances in
determining whether a child's health or welfare has been significantly
harmed or threatened. In evaluating a specific case, care providers
take into consideration not only the definitions of physical and sexual
abuse listed above, but also the circumstances surrounding the incident
and any behaviors that the child or youth exhibits as a result of the
abuse. Circumstances to consider include but are not limited to: the
amount of time that has passed since the abuse, the period of time in
which the abuse occurred, the cultural context in which the abuse
occurred, the age of the child or youth at the time of the abuse, and
the relationship between the youth and the perpetrator.
Care providers take into consideration the situations and behaviors
listed below, but do not make a determination based solely on the
presence or absence of one of them.
The child experiences on-going medical issues from physical
injuries.
The child exhibits negative or harmful behaviors, thoughts or
emotions, such as, but not limited to, excessive hostility or
aggression towards others, fire setting, cutting, depression, eating
disorders suicidal ideation, or substance abuse.
In evaluating difficult cases, the care provider should consult with
their ORR/FFS.
Revised 03/28/23
2.5 Sponsorship Assessment Background
Check Investigations
One of ORR's priorities is ensuring the safe release of unaccompanied
children to an appropriate sponsor. Consistent with ORR's mission and
in compliance with requirements found at 8 U.S.C. 1232(c)(3)(A) to
perform an independent finding that a potential sponsor has not engaged
in any activity that would indicate a potential risk to the child, ORR
generally requires a background check of all potential sponsors and for
any of their adult household members, except where indicated below.
As a general matter, ORR prioritizes the placement of unaccompanied
children with parents and legal guardians available to provide care and
custody in the United States. Where there are no safety concerns, ORR
does not require background checks or proof of identify for household
members and adult care givers when the sponsor is a parent or legal
guardian, so long as:
the child is not determined to be especially vulnerable through
ORR's screening and assessment process;
the child is not subject to a mandatory TVPRA home study; and
there are no other safety concerns present in the case,
including relating to abuse or neglect.
A Category 2A or 2B sponsor who is simultaneously sponsoring multiple
children related to them undergo the background check requirements of
the child most closely related to them. For example, a sponsor who is
the parent to one child and an uncle to another child, undergo the
unification requirements as a Category 1 sponsor for both children.
All potential sponsors undergo a public records background check of
criminal history and sex offender registry databases. Adult household
members of potential sponsors in Categories 2A, 2B, 3, and in some
cases Category 1, must also undergo public records background check of
criminal history and sex offender registry databases. Sponsors in
Categories 2B and 3, as well as some Category 1 and 2A sponsors, adult
household members, and adult caregivers identified in a sponsor care
plan require fingerprint background checks that are processed through
the U.S. Department of Justice's (DOJ) Federal Bureau of Investigation
(FBI).
ORR transmits fingerprint submissions (if required) to the U.S.
Department of Justice's (DOJ) Federal Bureau of Investigation (FBI) to
perform criminal history checks.\8\ The FBI submits the results to the
U.S. Department of Health and Human Services/Program Support Center
(HHS/PSC). HHS/PSC provides the results and notifies ORR that the
biometric and biographic checks conducted by the FBI are complete. HHS/
PSC also provides copies of the results to ORR.
---------------------------------------------------------------------------
\8\ An Authorization for Release of Information is not required for
sponsors, adult household members, or adult care givers identified in a
sponsor care plan undergoing a sex offender registry check. An
Authorization for Request of Information also is not required for
sponsors, adult household members and adult caregivers identified in a
sponsor care plan undergoing a public records check. However, sponsors
will receive notice that public records and sex offender registry
checks will be performed, and will have an opportunity to explain the
results of these checks to ORR. ORR will also provide a method for
disputing the results of checks. (See Section 2.5.3, Q4)
In some cases, ORR requires sponsors, adult household members, and
adult caregivers to undergo a background check search of State child
abuse and neglect (CA/N) registries maintained by individual States. In
these cases, HHS/PSC works with the relevant State agency or directs
the subject of the check to request results from the relevant State
agency in compliance with State law and regulation.
Effective 02/13/24
2.5.1 Background Check Requirements
To begin the background check process, the potential sponsor and adult
household members must first complete the Authorization for Release of
Information form (if applicable),\9\ and submit fingerprints and
provide a copy of a valid government issued photo identification (if
required). Adult caregivers identified in a sponsor care plan also
require background checks, as outlined in the chart below. The type of
background checks performed on a sponsor, adult household members, and
adult caregivers is dependent in part on the sponsor's relationship, if
any, with the child. See Section 2.2.1 Identification of Qualified
Sponsors for a description of sponsor categories.
---------------------------------------------------------------------------
\9\ As part of the FBI background check process, DHS databases are
searched. The FBI also forwards biographic information to ICE's Law
Enforcement Support Center (LESC). Neither HHS/PSC or ORR verify any
records produced by DHS for background check purposes.
The following table lists the types of background checks performed, and
explains when they are performed, based on the potential sponsor's
relationship to the unaccompanied child and other release
considerations. The table only indicates the minimum requirements for
the background check process for sponsors and others. ORR may require
additional checks, verifications, or procedures for sponsors and others
in any category if there are any unresolved issues or questions related
---------------------------------------------------------------------------
to the well-being of the child.
------------------------------------------------------------------------
TYPE OF
BACKGROUND CHECK PURPOSE PERSONS CHECKED WHEN PERFORMED
------------------------------------------------------------------------
Public Records Identifies Potential
Check arrests or Sponsors in
convictions of Categories 1-3
sponsors, adult
household
members, or
others. If a
check reveals a
criminal record
or safety issue,
it is used to
evaluate the
sponsor's
ability to
provide for a
child's physical
and mental well-
being
For all
------------------------------------------------------------------------
Sex Offender Identifies Potential
Registry Check, sponsors and Sponsors in
conducted others that have Categories 1-3
through the U.S. been adjudicated
Department of as sex offenders
Justice National through a
Sex Offender national search
Public Website and, if
available, a
local public
registry search
In all cases
------------------------------------------------------------------------
FBI National Determines Potential Where a public
Criminal History whether a Sponsors in records or sex
Check, based on sponsor or adult Category 1 and offender check
digital household member Category 2A reveals
fingerprints or (as applicable) possible
digitized paper has a criminal disqualifying
prints history, has a factors under
profile in DHS 2.7.4; or where
IDENT, has been there is a
convicted of a documented risk
sex crime, or to the safety
has been of the
convicted of unaccompanied
other crimes child, the
that compromise child is
the sponsor's especially
ability to care vulnerable, and/
for a child or the case is
being referred
for a home
study
------------------------------------------------------------------------
Potential In all cases
Sponsors in
Categories 2B
and 3
------------------------------------------------------------------------
Non-sponsor Where a public
adult household records or sex
members and offender check
adult reveals
caregivers possible
identified in a disqualifying
sponsor care factors under
plan 2.7.4; or where
there is a
documented risk
to the safety
of the
unaccompanied
child, the
child is
especially
vulnerable, and/
or the case is
being referred
for a home
study
------------------------------------------------------------------------
Child Abuse and Checks all Potential In cases that
Neglect (CA/N) localities in Sponsors in require a home
Check, obtained which the Categories 1-3 study, and
on a State by sponsor or cases where a
State basis as household member special concern
no national CA/N has resided in is identified
check repository the past 5 years
exists
------------------------------------------------------------------------
Non-sponsor In any case
adult household where a sponsor
members and is required to
adult undergo a CA/N
caregivers check
identified in a
sponsor care
plan
------------------------------------------------------------------------
State Criminal Assists in Potential
History locating police Sponsors in
Repository Check or arrest Categories 1-3
and/or Local records, or
Police Check other criminal
offense details,
as needed
Used on a case-
------------------------------------------------------------------------
Fingerprint Exception for Category 2B Cases with Qualifying Category 1
or 2A Sponsors
Fingerprints for a Category 2B sponsor of a case related to a Category
1 or Category 2A case may not be required, provided that all of the
following conditions apply:
1. The children are screened and determined to not be especially
vulnerable;
2. The children are not otherwise subject to a mandatory TVPRA
home study; and
3. There are no other red flags present in the case, including red
flags relating to abuse or neglect.
If one of the cases falls under one of these categories and the
other(s) does not, the case manager and case coordinator will make a
recommendation to the FFS whether to separate the cases for purposes of
processing. Case managers will document the exception in all children
in the family units? Release Request documents.
Effective 02/13/24
2.5.2 Results of Background Checks on Release Decisions
ORR uses the results from background checks to determine whether
release to a potential sponsor is safe. A potential sponsor may be
denied based on the results of a background check, and a release
decision may remain undecided until ORR obtains the results of a
potential sponsor's criminal history or child abuse and neglect
reports.
The biometric and biographical information, including fingerprints, are
shared with FBI to investigate criminal history through the National
Criminal Information Center and may be used consistent with their
authorities. Biometric and biographical information may be shared with
Federal, State or local law enforcement or State child welfare
agencies, as necessary, to conduct criminal history searches or search
for adverse child welfare findings.
Criminal History and Adverse Child Welfare Finding Results
In the event that a background check of a potential sponsor or, if
applicable, adult household member, reveals criminal history or a
safety risk, the care provider and ORR evaluate this information and
request the potential sponsor to provide any additional information
that may demonstrate the potential sponsor's ability to provide for the
child's physical and mental well-being.
If release is not barred by Section 2.7.4, the decision to release a
child or youth to a sponsor in these circumstances is based on all the
following considerations:
The severity of the criminal and/or child abuse/neglect history;
The length of time that has passed since the criminal act or
child abuse/neglect allegation occurred;
The relationship of the potential sponsor and other adult
household members to the child or youth; and
The evidence, if any, of rehabilitation since the criminal act
or child abuse/neglect allegation occurred.
In cases where the proposed sponsor or an adult household member has
been charged with, but not convicted of, a crime, ORR may postpone a
final release decision until the legal issue is resolved.
In cases where ORR has released a child and later obtains derogatory
information on a sponsor or sponsor household member, ORR determines
whether the information if known prior to release would have led to a
denial of sponsorship or presents some other high risk child welfare
concern. In these instances ORR contacts State CPS and/or local law
enforcement (as necessary) with jurisdiction over the sponsor's home
and provides them with ORR's findings. ORR may contact the sponsor in
certain situations to inform them of child welfare concerns post
release in these instances, especially where it concerns an individual
in the sponsor's home.
Summary Table of Results of Background Checks and Next Steps
The following table shows procedures following the results of
background checks.
------------------------------------------------------------------------
BACKGROUND CHECK
RESULTS NEXT STEPS
------------------------------------------------------------------------
No arrest record; Proceed with release decision-making process. See
check completed Section 2.7 Recommendations and Decisions on
Release.
------------------------------------------------------------------------
Criminal arrest Determine whether release is barred. See Section
record and/or 2.7.4 Deny Release Request. If release is not
substantiated barred, elevate safety issues for third party
adverse child review. For any findings that could affect safe
welfare findings; release, care provider and/or ORR will obtain
check completed additional documents to determine current
situation (e.g., sponsor is on probation,
criminal charges are resolved, etc.). Final
release decision shall take into account the
criminal records and all other relevant
information that is available.
------------------------------------------------------------------------
Criminal history ORR/FFS will provide instructions to care
pending results; provider.
check not complete
------------------------------------------------------------------------
CA/N pending results ORR may choose to release a child pending CA/N
results if there are no significant child welfare
concerns associated with the sponsor or an adult
in the sponsor's home, with the UC or other
children.
------------------------------------------------------------------------
Revised 06/18/19
2.5.3 Commonly Asked Questions on the ORR Background Check Process
Q1: Where can a sponsor get his or her fingerprints taken?
A1: ORR funds a network of digital fingerprint providers at locations
that are not affiliated with law enforcement entities. Sponsors may
also go to any local police department for paper fingerprinting
services in the event a digital fingerprint provider is not
conveniently located near a sponsor's location. Fingerprinting services
are not available at ORR headquarters or at HHS/PSC offices.
Q2: Are potential sponsors required to disclose to the care provider
that they have a record of a criminal charge or child abuse?
A2: Yes. The sponsor must immediately advise the care provider of this
situation and gather detailed documentation of the charges,
dispositions, police reports, and evidence of rehabilitation.
Q3: What happens if a public records or sex offender registry check
returns disqualifying findings for a sponsor, adult household member,
or adult caregiver identified in the sponsor care plan?
A3: The Case Manager informs the sponsor, and provides the sponsor with
a copy of the results. The sponsor and household member/adult caregiver
may dispute the results, and provide further evidence or information
that a check was not performed correctly (e.g., the wrong date of birth
was used, the individual's name was spelled incorrectly, etc.). The
Case Manager reruns the check using the corrected information. If
further information is required, such as additional background checks,
the Case Manager contacts the sponsor and household member/adult
caregiver to obtain the information, or make other arrangements so that
the safety risk to the unaccompanied child is mitigated (e.g., taking
steps so that the household member no longer resides in the sponsor's
home, identifying a new adult caregiver, etc.).
Q4: What happens if an adult household member refuses to cooperate with
a background check?
A4: ORR may deny release when an adult household member refuses to
cooperate with a background check. In such cases, ORR considers the
totality of the circumstances, including the adult household member's
refusal and all other relevant and available information to determine
whether the release process may continue. ORR determines the best
interests of a child and does not release any child to a sponsor until
ORR has determined that it is safe to do so.
Q5: Do background checks expire?
A5: Yes. The FBI National Criminal History Check, Child Abuse and
Neglect (CA/N) Check, and State Criminal History Repository Check and/
or Local Police Check all expire 270 days from the day results are
received. The Public Records Check and Sex Offender Registry Check
expire 90 days from the day ORR receives results. ORR requires new
background checks if the previous results have expired prior to ORR
approving the child's release; this includes obtaining a new set of
fingerprints (re-fingerprinting) when applicable.
Q6: Does ORR share the results of the FBI fingerprint checks with other
parties?
A6: ORR does not release the results of the FBI fingerprints to outside
organizations or individuals, or to ORR care providers. The FBI
searches DHS databases that may contain overlapping records. The FBI
system automatically initiates a notification to the DHS system if a
particular record has been searched.
Q7: Can DHS use information gathered from the ORR background check
process to enforce immigration policies against potential sponsors or
others?
A7: Until September 30, 2021, DHS is restricted from using a background
check subject's information for immigration enforcement actions such as
placing a subject in detention, removal, referring the individual for a
decision on removal, or starting removal proceedings. Generally stated,
they include: certain felonies; an association with a business that
employs minors and does not pay a legal wage or prevents the minor from
going to school; or an association with prostitution. The felonies
include: (A) an aggravated felony as defined in 8 U.S.C. 1101(a)(43);
(B) child abuse; (C) sexual violence or abuse; or (D) child
pornography. An aggravated felony, is defined at 8 U.S.C.
Sec. 1101(a)(43), and includes a listing of 21 different kinds of
crimes.
If the subject of a background check is concerned about having been
charged or convicted of a crime, Case Managers make a request that the
subject talk to an attorney about whether their criminal history would
fit the definition.
Revised 06/4/21
2.6 Sponsor Immigration Status and Release
of Unaccompanied Children
ORR does not disqualify potential sponsors based solely on their
immigration status or for law enforcement purposes.
ORR does not collect information on immigration status directly from
the sponsor. However, the Federal Bureau of Investigation (FBI)
searches Department of Homeland Security (DHS) databases as part of the
FBI national criminal background check (see Section 2.5 Sponsorship
Assessment Background Check Investigations, https://www.acf.hhs.gov/
orr/policy-guidance/unaccompanied-children-program-policy-guide-
section-2#2.5) and ORR may obtain immigration status information
through background check results. ORR does not share FBI background
check results, or any immigration status information contained therein,
with outside individuals or with ORR care providers (see Section 2.5.3
Commonly Asked Questions on the ORR Background Check Process). In
addition, ORR does not use or share any information for immigration
enforcement purposes (see Section 5.10 Information Sharing).
If ORR learns through background check results that the sponsor has an
outstanding or pending order of removal that is related to an
underlying criminal act, the decision to release a child to a sponsor
in these circumstances is based on the considerations described in
Section 2.5.2 Results of Background Checks on Release Decisions.
Revised 01/30/23
2.7 Recommendations and Decisions on Release
ORR care providers must make a recommendation to release a child to a
potential sponsor after the care provider has completed the full
assessment of the sponsor, including completed background checks, and
collected necessary documentation to prove the sponsor's identity and
relationship to the child. The recommendation must take into
consideration all relevant information, including the report from a
home study, if conducted; the child advocate's recommendation, if
appointed; DHUC's recommendation, if the child has a complex medical or
mental health related issue which implicates whether a child may be
released safely to a sponsor with available community supports; laws
governing the process; and other factors in the case. The ORR care
provider makes a recommendation for release if the care provider
concludes that the release is safe, and the sponsor is capable of
providing for the physical and mental well-being of the child.
The Case Manager and the Case Coordinator must make a
recommendation tothe ORR/FFS on the release of the unaccompanied child
to a particular sponsor. If the case manager and case coordinator
cannot agree on a particular recommendation, or if the case is
particularly complicated, they may refer the case directly to an ORR/
FFS for guidance on how to proceed.
After receiving the recommendation, the ORR/FFS and/or other
ORR/Headquarters staff reviews the recommendation.
Acting as an agent of HHS/ORR, the FFS makes a release decision
in consideration of the recommendations from the care provider, the
case coordinator, DHUC, and other stakeholders, including the home
study provider and the child advocate, where applicable.
Only ORR (or ACF) has the authority to make the final decision on a
release. FFS act as agents of HHS/ORR to approve unaccompanied children
release requests. The case manager, case coordinator, and other
stakeholders have an important role in making recommendations. In some
cases, the FFS may remand a case back to the case coordinator and case
manager to obtain additional information before they make a final
release decision.
The ORR/FFS must make one of the following release decisions:
Approve release to sponsor
Approve release with post-release services
Conduct a home study before a final release decision
Deny release
Remand for further information
Effective 02/13/24
2.7.1 Approve Release Decisions
A recommendation for a release without a home study or post-release
services is made after a thorough assessment of the sponsor, the
sponsor's family unit, and the needs of the child or youth are taken
into consideration. The ORR/FFS, acting as an agent of HHS/ORR, makes
this release decision when they determine that the release is a safe
release, the sponsor can care for the health and well-being of the
child, and the sponsor understands that the child is to appear for all
immigration proceedings.
Posted 03/28/23
2.7.2 Approve Release with Post-Release Services
The ORR/FFS, acting as an agent of HHS/ORR, may approve a release with
post-release services when the release is determined to be safe and
appropriate, but the unaccompanied child and sponsor need additional
assistance to connect them to appropriate resources in the community or
to address other concerns, such as mental health or other needs that
could benefit from ongoing assistance from a social welfare agency. The
sponsor must consent before services may be provided and may withdraw
his or her consent at any time after services have begun, since post-
release services are a voluntary service. See Section 6.2 Post Release
Services (https://www.acf.hhs.gov/orr/policy-guidance/unaccompanied-
children-program-policy-guide-section-6#6.2).
Revised 03/28/23
2.7.3 Conduct a Home Study Before a Final Release Decision Can Be Made
The Case Manager and Case Coordinator will recommend to the ORR/FFS
that a home study be conducted prior to making a release
recommendation. If the ORR/FFS agrees then, acting as an agent of HHS/
ORR, they will approve that a home study be conducted before a final
release decision can be made. The home study provider uses a
standardized template to complete the review; however, the provider may
include any additional supporting documentation regarding the sponsor
or the child or youth, as applicable.
Once the Case Manager and Case Coordinator receive the home study
results, they will review the case in light of the home study and make
a release recommendation to the ORR/FFS. (See Section 2.4.2 Home Study
Requirements, https://www.acf.hhs.gov/orr/policy-guidance/
unaccompanied-children-program-policy-guide-section-2#2.4.2)
Posted 03/28/23
2.7.4 Deny Release Request
ORR will deny release to a potential sponsor if any one of the
following conditions exists:
The potential sponsor is not willing or able to provide for the
child's physical or mental well-being;
The physical environment of the home presents risks to the
child's safety and well-being;
Release of the unaccompanied child would present a risk to him
or herself, the sponsor, household, or the community; or,
ORR may deny release to a Category 1 potential sponsor, and will deny
release to a Category 2A/2B or Category 3 potential sponsor, if any one
of the following conditions exists:\10\
---------------------------------------------------------------------------
\10\ ORR will also reject any sponsor care plans that identify an
adult care giver who has any of the disqualifying criteria.
---------------------------------------------------------------------------
The potential sponsor or a member of the potential sponsor's household:
Has been convicted of (including plea of no contest to) a felony
involving child abuse or neglect, spousal abuse; a crime against a
child or children (including child pornography); or a crime involving
violence, including rape, sexual assault or homicide;
Has been convicted within the last 5 years of a felony involving
physical assault, battery, or drug-related offenses;
Has been convicted of a misdemeanor for a sex crime, an offense
involving a child victim, or a drug offense that compromises the
sponsor's ability to ensure the safety and well-being of the child;
Has been convicted of alien smuggling or a crime related to
trafficking in persons; or
Has other criminal history or pending criminal charges or child
welfare adverse findings from which one could reasonably infer that the
sponsor's ability to ensure the safety and well-being of the child is
compromised;
or
A potential sponsor or a member of the potential sponsor's
household has one of the following substantiated adverse child welfare
findings:\11\
---------------------------------------------------------------------------
\11\ See U.S. Department of Health and Human Services, Children's
Bureau. Grounds for involuntary termination of parental rights, at 2.
Washington, DC: Child Welfare Information Gateway, January 2013.
---------------------------------------------------------------------------
Severe or chronic abuse or neglect;
Sexual Abuse or other sexual offenses;
Abuse or neglect of other children in the household;
Long-term mental illness or deficiency;
Long-term alcohol or drug induced incapacity; or
Involuntary termination of the parental rights to another
child.
Revised 06/18/19
2.7.5 Remand Release Request--Decision Pending
The ORR/FFS may remand the release request, which means that the ORR/
FFS is sending the recommendation back to the Case Manager for
additional information or additional actions before a final release
decision can be made. ORR records the date of the remand and the
decision will be pending further review until the documentation is
provided or actions are taken.
Posted 01/27/15
2.7.6 Issues Related to Recommendations and Decisions
Safety Plan
Case managers, in consultation with Case Coordinators, prepare a safety
plan, as needed, to address any outstanding needs the child may have
after they are released and to ensure the child's safe and successful
integration into the sponsor family unit and community. The goal of the
safety plan is to ensure the child's safety. The safety plan also has
guidance for sponsors on participating in post-release services and on
other areas of care critical to the child's adjustment in the family
and the community, such as maintaining mental health services for the
unaccompanied child, accessing any needed special education, helping
the child avoid drugs and alcohol, and using appropriate parenting
techniques.
Sponsor Care Plan
A sponsor care plan identifies an adult caregiver who will assume care
of an unaccompanied child if the sponsor becomes unable to care for the
child. ORR requires a sponsor care plan for all potential sponsors. The
goal is to ensure an unaccompanied child has a caregiver, despite any
complications that may arise after release to their sponsor.
The plan:
Identifies an adult caregiver, and their relationship to the UC
and sponsor, if any;
Includes copies of the adult caregiver's vetting information
(background check results, identifying documentation, etc.);
Includes the adult caregiver's contact information;
Discusses how the adult caregiver is notified that a transfer of
care is required, if required;
Provides that the adult caregiver will abide by the terms of the
Sponsor Care Agreement;
Includes the date the UC's Case Manager discusses the plan with
the child's sponsor and the adult caregiver identified in the plan;
and,
Includes additional information and materials (e.g., a Safety
Plan), as appropriate or when required by ORR.
A copy of the sponsor care plan is maintained in the UC's case file,
provided to the sponsor, and to the adult caregiver identified in the
plan.
Revised 01/30/23
2.7.7 Notification of Denial
If ORR denies the reunification application of a potential Category 1,
2A, or 2B sponsor, the ORR Director or their neutral and detached
designee sends that potential sponsor a Notification of Denial Letter
after receiving all the required information and documentation in a
specific case. If the sole reason for denial of release is related to a
concern that the unaccompanied child is a danger to themselves or the
community, the ORR Director sends to the child and their attorney of
record a copy of the Notification of Denial Letter that was sent to the
potential Category 1, 2A, or 2B sponsor.
The Notification of Denial Letter includes:
An explanation of the reason(s) for the denial;
Evidence and information supporting ORR's denial decision, with
instructions for obtaining a copy of the child's case file;
Instructions for requesting an appeal of the denial (see Section
2.7.8 Appeal of Release Denial, https://www.acf.hhs.gov/orr/policy-
guidance/unaccompanied-children-program-policy-guide-section-2#2.7.8);
Notice that the potential sponsor may submit additional
evidence, in writing before a Hearing occurs, or orally during a
hearing;
Notice that the potential sponsor may present witnesses and
cross-examine ORR's witnesses, if such witnesses are willing to
voluntarily testify; and
Notice that the potential sponsor may be represented by counsel
in proceedings related to the release denial at no cost to the Federal
Government.
If ORR denies sponsorship to a potential Category 3 sponsor, the care
provider notifies the potential sponsor, providing the reasons for the
denial verbally. If the sole reason for denial of release is a concern
that the unaccompanied child is a danger to themselves or the
community, the ORR Director sends a Notification of Denial Letter to
the child as described above.
Revised 07/21/23
2.7.8 Appeal of Release Denial
Category 1, 2A, or 2B sponsor applicants may seek an appeal of ORR's
denial decision by submitting a written request to the Assistant
Secretary, Administration for Children and Families, or their neutral
and detached designee within 30 business days of receipt of the final
decision from ORR. The appeal request must follow the instructions that
accompanied the Notification of Denial Letter that was sent to the
potential sponsor by the ORR Director or the ORR Director's designee.
The Notification of Denial Letter includes information as set forth in
Section 2.7.7 Notification of Denial.
The requestor may seek an appeal with a hearing or without a hearing.
The Assistant Secretary or their neutral and detached designee will
acknowledge the request for appeal within five (5) business days of
receipt. The appeal process shall be completed within 30 calendar days
of receipt of the appeal request unless an extension of time is
warranted to accommodate the schedule of either the potential sponsor
or the Assistant Secretary or their neutral and detached designee.
Without a Hearing:
If the requester seeks an appeal without a hearing, the Assistant
Secretary or their neutral and detached designee will consider only:
The Notification of Denial Letter and any information referenced
therein;
The appeal request; and
Any additional supporting materials or information submitted by
the requester.
The Assistant Secretary or their neutral and detached designee will
notify the requester of a decision within 30 calendar days of receiving
the request unless an extension was warranted to accommodate the
schedule of either the potential sponsor or the Assistant Secretary or
their neutral and detached designee. If more information is needed to
make a decision, or for good cause, the Assistant Secretary or their
neutral and detached designee may stay the request until they have the
information needed. In these cases, the Assistant Secretary or their
neutral and detached designee will send a written explanation to the
potential sponsor, communicating a reasonable process and timeframe for
addressing the situation and making a determination.
With a Hearing:
If the requester seeks a hearing, the Assistant Secretary or their
neutral and detached designee will schedule a teleconference or video
conference, per the potential sponsor's preference, at which time the
potential sponsor (or the potential sponsor's representative) may
explain the reasons why they believe the denial was erroneous. In
addition, the potential sponsor may offer evidence or additional
material in support of the request to reverse the release denial.
The Assistant Secretary or their neutral and detached designee will
consider the testimony and evidence presented at the hearing, in
addition to the original denial letter and information referenced
therein, to make a determination. The Assistant Secretary or their
neutral and detached designee will notify the requester of the decision
in writing within 30 calendar days of receiving the request for the
hearing unless an extension was warranted to accommodate the schedule
of either the potential sponsor or the Assistant Secretary or their
neutral and detached designee.
The Assistant Secretary or their neutral and detached designee makes a
determination based on the relevant law, regulations, and policies
concerning release decisions (see Section 2.7.4 Deny Release Request
for the basis of a release denial). Any evidence submitted to the
Assistant Secretary or their neutral and detached designee by ORR is
shared with the requester in compliance with privacy protections. The
Assistant Secretary or their neutral and detached designee conducts a
de novo review and may affirm or overturn the ORR Director's or their
designee's decision or send the case back to ORR for further action.
Appeal hearings are recorded, and the requester may request a copy of
the recording.
The Assistant Secretary's or their neutral and detached designee's
decision to affirm or overrule the ORR Director's or their designee's
decision to deny release to a potential sponsor is the final
administrative decision of the agency on the application that had been
under consideration. However, if there is new information or a change
in circumstances regarding the reunification application, or regarding
the unaccompanied child's circumstances, a new reunification
application may be submitted that highlights the change(s) and explains
why such changes should alter the initial decision. Similarly, if ORR
discovers new information or becomes aware of a change in the
circumstances of the potential sponsor and/or the unaccompanied child,
ORR may assess the case anew.
Denial for sole reason that the unaccompanied child is a danger to
themselves or the community
If the sole reason for denial of release is concern that the
unaccompanied child is a danger to themselves or the community, the
unaccompanied child may seek an appeal of the denial as described
above, provided the Category 1, 2A, or 2B potential sponsor is not
seeking an appeal (see Section 2.7.7 for Notification of Denial). If
the child expresses a desire to seek an appeal, ORR encourages the
child to consult with their attorney of record or a legal service
provider for assistance with the appeal. The unaccompanied child may
seek such appeal at any time after denial of release while the child is
in ORR custody.
Revised 10/27/22
2.7.9 90-Day Review of Pending Family Reunification Applications
ORR reviews the cases of all pending sponsor applications for
unaccompanied children (UC) in ORR custody for 90 days. The purpose of
this review is to identify and resolve the reasons that a family
reunification application remains pending in a timely manner. Upon
completion of the review, Case Managers will update the sponsor and UC
on the status of the case, highlighting the reasons that the family
reunification process is incomplete. In addition, the Case Manager will
work with the sponsor, relevant stakeholders, and the ORR/FFS on a plan
to address the portions of the application that remain incomplete in
accordance with Section 2.2.3 The Family Reunification Application.
For cases that are not resolved after the initial 90-Day Review, ORR
will conduct additional reviews every 90 days until the pending sponsor
application is resolved in accordance with Section 2.7 Recommendations
and Decisions on Release.
Posted 10/27/22
2.8 Release from Office of Refugee
Resettlement (ORR) Custody
Release from the ORR custody is a three-step process:
After care planning, which occurs during the entire safe and
timely release process.
Transfer of physical custody of the child, which occurs as soon
as possible once an unaccompanied child is approved for release.
Closing the case file, which occurs within 24 hours of the
unaccompanied child's discharge.
Posted 01/27/15
2.8.1 After Care Planning
Throughout the release process, care providers work with the child and
sponsor so that they can plan for the child's after care needs. This
involves working with the sponsor and the child to:
Prepare them for post-ORR custody
Assess the sponsor's ability to access community resources
Provide guidance regarding safety planning, sponsor care plans,
and accessing services for the child
Once the sponsor assessment is complete and a sponsor has been
approved, the sponsor enters into an agreement with the Federal
Government in which he or she agrees to comply with the following
provisions (see Sponsor Care Agreement, https://www.acf.hhs.gov/orr/
policy-guidance/unaccompanied-children-program#
Family%20Reunification%20Packet%20for%20Sponsors):
Provide for the physical and mental well-being of the child,
including but not limited to, food, shelter, clothing, education,
medical care and other services as needed.
Enroll the child in school and ensure their attendance,
following the requirements of the State in which you live, and
otherwise support their academic success. For example, the child may
benefit from supplemental classes or services, such as English as a
Second Language (ESL), tutoring, or summer school.
For those who are not the child's parent or legal guardian, make
best efforts to establish legal guardianship with the local court
within a reasonable time.
Attend a legal orientation program provided under the Department
of Justice/Executive Office for Immigration Review's (EOIR) Legal
Orientation Program for Custodians (Sponsors), if available where they
reside.\12\
---------------------------------------------------------------------------
\12\ Sponsors are provided a Legal Orientation Program for
Custodians Overview flyer as part of the Family Reunification Package
that contains further information.
Depending on where the child's immigration case is pending,
notify the local Immigration Court or the Board of Immigration Appeals
within five (5) days of any change of address or phone number of the
child by using DOJ's Change of Address form (Form EOIR-33). In
addition, if necessary, file a Change of Venue motion on the child's
behalf.\13\
---------------------------------------------------------------------------
\13\ ``Change of venue'' is a legal term for moving an immigration
hearing to a new immigration court location. The Change of Venue motion
must contain information specified by the Immigration Court. A Change
of Venue motion may require the assistance of an attorney. For guidance
on the ``motion to change venue,'' see the Immigration Court Practice
Manual at www.
justice.gov/eoir/reference-materials/ic. For immigration case
information please contact EOIR's immigration case information system
at 1-800-898-7180. Visit EOIR's website for additional information at:
www.justice.gov/eoir.
Notify the Department of Homeland Security (DHS)/U.S.
Citizenship and Immigration Services within 10 days of any change of
address by filing DHS's Change of Address Card (AR-11) or
electronically at www.uscis.gov/ar-11. Sponsors in need of assistance
may call or text the ORR National Call Center at 1-800-203-7001 or
---------------------------------------------------------------------------
email information@ORRNCC.com.
Notify ORR immediately if the child permanently leaves the
sponsor's custody and provide updated contact information for the child
by calling or texting the ORR National Call Center at 1-800-203-7001,
or emailing information@
ORRNCC.com.
Notify ORR within 30 days of any change of address and provide
updated contact information by calling or texting the ORR National Call
Center at 1-800-203-7001, or emailing information@ORRNCC.com. The
sponsor must continue to notify ORR of any change of address for a
period of three (3) years after the child is released into their
custody or while the sponsor is receiving post-release services,
whichever come later. However, if the child if the child turns 18,
their immigration case is resolved, or they permanently leave the
sponsor's custody before three (3) years, the sponsor does not need to
continue notifying ORR of address changes.
Ensure the child's presence at all future proceedings before the
DHS/Immigration and Customs Enforcement (ICE) and the DOJ/EOIR.
Ensure the child reports to ICE for removal from the United
States if an immigration judge issues a removal order or voluntary
departure order. The child is assigned to a Deportation Officer for
removal proceedings.
Notify the U.S. Department of Labor, Wage and Hour Division if
the sponsor or the child are being forced to work against their will,
to repay a debt, or in unsafe conditions by calling 1-866-4-USWAGE (1-
866-487-9243) or visiting https://webapps.dol.gov/contactwhd.
Notify local law enforcement or State or local Child Protective
Services if the child has been or is at risk of being subjected to
abuse, abandonment, neglect or maltreatment or if the sponsor learns
that the child has been threatened, has been sexually or physically
abused or assaulted, or has disappeared. Notice should be given as soon
as it is practicable or no later than 24 hours after the event or after
becoming aware of the risk or threat.
Notify the National Center for Missing and Exploited Children at
1-800-843-5678 and the ORR National Call Center at 1-800-203-7001 or
information
@ORRNCC.com if the child disappears, has been kidnapped, or runs away.
Notice should be given as soon as it becomes practicable or no later
than 24 hours after learning of the child's disappearance.
Notify ICE at 1-866-347-2423 if the child is contacted in any
way by an individual(s) believed to represent a smuggling syndicate,
organized crime, or a human trafficking organization. Notice should be
provided as soon as possible or no later than 24 hours after becoming
aware of the information.
In case of an emergency (serious illness, destruction of home,
etc.), temporarily transfer physical custody of the child to another
person who will comply with the terms of the Sponsor Care Agreement.
In the event that a sponsor who is not the child's parent or
legal guardian is no longer able and willing to care for the child and
is unable to temporarily transfer physical custody to an alternative
caregiver, and the child meets the definition of an unaccompanied
child, notify the ORR National Call Center at 1-800-203-7001 or
information@ORRNCC.com.
The agreement includes the notice that the release of the child to the
sponsor's care does not grant the child any legal immigration status
and that the child must present himself or herself for immigration
court proceedings.
The care provider also provides the sponsor with a Sponsor Handbook
that outlines the responsibilities in caring for the child's needs for
education, health, obtaining legal guardianship, finding support to
address traumatic stress, keeping children safe from child abuse and
neglect and from trafficking and exploitation. The handbook reiterates
the importance of continuing with immigration proceedings and includes
links to EOIR's website and forms. The handbook discusses laws related
to employment, such as the Federal law prohibiting minors under the age
of 18 from working in hazardous occupations.
After care planning includes the care provider explaining the following
to the child and the sponsor:
The U.S. child abuse and neglect standards and child protective
services that are explained on the Administration for Children and
Families Child Welfare Information Gateway (https://www.acf.hhs.gov/
orr/policy-guidance/unaccompanied-children-
program#Family%20Reunification%20Packet%20for%20
Sponsors) website.
Human trafficking indicators and resources.
Basic safety and how to use the 911 number in emergency
situations.
The care provider notifies all stakeholders of the child's discharge
date and change of address and venue, as applicable. Where applicable,
ORR also provides child advocates with access to their clients'
documents and forms, and helps child advocates to remain informed about
their clients' after-care plans and legal proceedings. The care
provider coordinates with the legal service provider or attorney of
record to help complete the necessary legal forms. Stakeholders
notified of the change of address and, if applicable, request for
change of venue for the immigration case include the U.S. Immigration
and Customs Enforcement (ICE) Office of Chief Counsel and the U.S.
Executive Office for Immigration Review (EOIR) Immigration Court
Administrator.
Revised 03/25/24
2.8.2 Transfer of Physical Custody
Once ORR approves an unaccompanied child for release, the care provider
collaborates with the sponsor to ensure physical discharge happens as
quickly as possible (within 3 calendar days after ORR approves the
release). The care provider notifies DHS prior to the physical release
to allow DHS an opportunity to comment on the imminent release as well
as time to prepare any DHS paperwork for the ICE Chief Counsel's
office.
The care provider ensures that all the child's belongings--including
those he or she had at the time they entered ORR custody and any they
acquired during their stay--are given to the child and sponsor at time
of release. The care provider also makes sure that the child and
sponsor have copies of files or papers needed for the child to obtain
medical, educational, legal or other services following release.
Whenever possible, sponsors are expected to come to the care provider
or to an offsite location designated by the care provider for the
transfer of physical custody of the child.
Escorting Children to a Sponsor
Under extenuating circumstances (e.g., a sponsor cannot travel due to a
medical condition), ORR may approve an unaccompanied child to be
escorted to a sponsor. Similarly, if a sponsor pick-up would result in
delay of a timely release of the child, ORR may approve an escort for
an unaccompanied child.
If an unaccompanied child's final destination involves air travel and
the sponsor will not be traveling with the child, the care provider
must follow the procedures in the table below concerning care provider
escorts and airline escorts.
Unaccompanied children who are under the age of 14 years old traveling
via air may only be escorted by care provider staff, unless an ORR/FFS
Supervisor has approved the use of an airline escort in advance.
Sponsors are not required to use a travel agent proposed or used by a
care provider if they are able to find lower airfare using another
agent or airline, provided escort conditions are met.
The following table summarizes procedures for each method of transfer.
------------------------------------------------------------------------
METHOD OF
TRANSFER PRE-TRANSFER STEPS AT POINT OF TRANSFER
------------------------------------------------------------------------
Sponsor pick-up Case manager Care provider checks the
at care collaborates with the sponsor's identification
provider sponsor on selecting a upon arrival by comparing
facility date and time for the it to the identification
sponsor to pick-up the previously submitted by
child the sponsor in the FRP
(see Section 2.2.4)
Case manager notifies If the sponsor's
the sponsor that he/she identification matches
is required to bring the the identification
same valid government previously submitted,
issued photo care provider gives the
identification previously sponsor the unaccompanied
submitted by the sponsor child's release documents
in the FRP (see Section and personal possessions
2.2.4)
Care provider advises
the sponsor, if traveling
by airplane, to check in
the child at the ticket
counter with a copy of
the child's DHS form I-
862, Notice to Appear
Care provider may not
release the child unless
the sponsor presents the
same valid government
issued photo
identification he or she
submitted in the FRP
Case manager If traveling by air, at
collaborates with the the departure airport,
sponsor in selecting a care provider escort
time and location for checks in the child at
transfer, and flights for the ticket counter with a
the child and care copy of the child's DHS
provider escort form I-862, Notice to
Appear
Case manager notifies At the transfer
the sponsor that he/she location, care provider
is required to bring the escort compares the
same valid government sponsor's identification
issued photo with the copy previously
identification previously submitted by the sponsor
submitted by the sponsor in the FRP. If the
in the FRP to the identification documents
transfer location correspond, care provider
escort releases the child
to the sponsor and
provides the sponsor with
the release documents and
the child's personal
effects and papers
Care provider Case manager arranges or Care provider escort may
escort to assists in arranging the not release the child
offsite child and care provider unless the sponsor
transfer escort's transportation, presents the same valid
location including airline tickets government issued photo
where applicable identification he or she
Case manager prepares a submitted in the FRP. If
copy of the sponsor's the sponsor does not
identification that was produce valid
submitted in the FRP, for identification, if the
the care provider escort care provider escort has
to take to the transfer concerns regarding the
location sponsor's identity, or if
the care provider escort
has concerns regarding
the safety of the
situation upon meeting
the sponsor, the care
provider escort will
return with the child to
the care provider
facility
Travel via Case manager contacts At the departure
airline's the airline to obtain airport, care provider
unaccompanied information on airline checks in the
minor escort escort requirements, in unaccompanied child at
policy (only order to ensure that they the ticket counter with a
for youth 14 are adequate to protect copy of the DHS form I-
years of age the safety of the child, 862, Notice to Appear,
and older) and to ensure that both and a copy of the
the sponsor and the care approved identification
provider can meet the of the sponsor picking up
requirements the child
Case manager arranges or At the departure
assists in arranging the airport, care provider
child and care provider gives the child their
escort's transportation, personal possessions and
including airline tickets documents and a copy of
where applicable the sponsor's approved
identification, and mails
an additional copy of the
release documents to the
sponsor
Case manager ensures At the destination
that the government airport, the sponsor
issued photo arrives 2 hours before
identification submitted the child's arrival time,
by the sponsor in the FRP and contacts the care
will be acceptable to the provider immediately to
airline to complete check in
custody transfer
The care provider The airline follows its
instructs the sponsor to standard procedures for
meet the unaccompanied escorting a child
child and escort at the traveling alone to the
airport with the designated parent or
identification they guardian
submitted in the FRP, and The care provider
to follow the contacts the sponsor
requirements of the shortly after the child's
airline's unaccompanied scheduled arrival time to
minors escort policy confirm the child's
transfer from the airline
representative to the
sponsor
If the sponsor fails to
arrive at the airport or
fails to contact the care
provider upon arrival at
the airport, the care
provider will notify the
ORR/FFS and the Project
Officer, and the child
will either be returned
to the care provider or
taken to another nearby
care provider facility
------------------------------------------------------------------------
When arranging for children to travel with airline escorts, care
providers should also refer to the U.S. Department of Transportation
recommendations for unaccompanied minors traveling by air (``When Kids
Fly Alone,'' https://www.
transportation.gov/airconsumer/when-kids-fly-alone).
Revised 01/10/22
2.8.3 Closing the Case File
The care provider completes a Discharge Notification form within 24
hours of the physical discharge of a youth, and then emails the form to
DHS and other stakeholders. Once a child is released to a sponsor,
ORR's custodial relationship with the child terminates.
Although the custodial relationship ends, the care provider keeps the
case file open for 30 days after the release date in order to conduct
the Safety and Well Being Follow Up Call (see Section 2.8.4) and
document the results of the call in the case file. The care provider
closes the case file record after completing the Safety and Well Being
Follow Up Call.
Revised 03/14/16
Section 2.8.4 Safety and Well Being Follow Up Call
Care providers must conduct a Safety and Well Being Follow Up Call with
an unaccompanied child and his or her sponsor 30 days after the release
date. The purpose of the follow up call is to determine whether the
child is still residing with the sponsor, is enrolled in or attending
school, is aware of upcoming court dates, and is safe. The care
provider must document the outcome of the follow up call in the child's
case file, including if the care provider is unable to contact the
sponsor or child after reasonable efforts have been exhausted. If the
follow up call indicates that the sponsor and/or child would benefit
from additional support or services, the care provider must refer the
sponsor or child to the ORR National Call Center and provide the
sponsor or child the Call Center contact information. If the care
provider believes that the child is unsafe, the care provider must
comply with mandatory reporting laws, State licensing requirements, and
Federal laws and regulations for reporting to local child protective
agencies and/or law enforcement.
Revised 03/14/16
2.8.5 Post-Release Services for UC with Zika Virus Disease or
Infection
[REPEALED]
2.8.6 Release for Children with Legal Immigration Status
Some unaccompanied children may obtain legal immigration status while
in ORR care. ORR may also discover during the process of placing and
providing services to a child that he or she already has legal
immigration status or is a U.S. citizen. By law, ORR is not authorized
to have custody of children with legal immigration status or U.S.
citizenship. Therefore, these children cannot remain in ORR's care, and
ORR must promptly release them from ORR-funded care provider
facilities.
As soon as ORR determines that an unaccompanied child may be eligible
for legal status, ORR begins development of a Post Legal Status Plan.
The case manager develops the plan, and ORR approves it, tailoring it
to the needs and pending immigration status of the child.
As is the case for all UC, ORR continually makes efforts to reunify
children who have promising immigration cases with family members.
However, if no parent, legal guardian, relative, or other suitable
adult is available, ORR and the care provider, as part of the
development of the Post Legal Status Plan, identify alternative
placements for the child, including specialized programs, State or
county entities or licensed nonprofit organizations that will take
custody of the child. In limited circumstances, children with certain
types of immigration status may be eligible for release into ORR's
Unaccompanied Refugee Minors (URM) Program. Placement in the URM
Program is limited by type of immigration status and the availability
of appropriate placement options. ORR will not release children on
their own recognizance under any circumstances.
Posted 05/8/17
2.8.7 Release of Saravia Class Members
Generally, ORR must release a UC to the previous sponsor within 3
calendar days of a successful Saravia hearing unless one of the
following exceptions applies:
The sponsor is physically unavailable (e.g., has been removed
from the United States, imprisoned, cannot be located, or is unwilling
to take the minor back);
There has been abuse or neglect (e.g., ORR has evidence that the
prior sponsor, or individuals in the sponsor's household, have abused
or neglected the UC or other children in the sponsor's home); or
The UC was previously released to a Category 2B or Category 3
sponsor but the child was not living with that sponsor immediately
prior to arrest. (For UC who are arrested by ICE after serving time in
a local jail, ORR releases to the previous Category 2B or Category 3
sponsor within 3 calendar days if the UC was living with that sponsor
immediately prior to their arrest by local authorities.)
Where release is not possible for one of the reasons above, ORR follows
the standard safe and timely release process (see Section 2 Safe and
Timely Release from ORR Care, https://www.acf.hhs.gov/orr/policy-
guidance/unaccompanied-children-program-policy-guide-section-2).
However, this process shall not take into account any prior allegations
of gang affiliation that existed at the time of a Saravia class
membership determination.
If a Saravia class member returns to ORR custody after not having
prevailed at his or her Saravia hearing, ORR follows its normal
policies and procedures for release of the UC.
Posted 02/12/21
2.9 Bond Hearings for Unaccompanied Children
Consistent with the Ninth Circuit Court of Appeals decision in Flores
v. Sessions, unaccompanied children have the opportunity to seek a bond
hearing with an immigration judge.
In a bond hearing, an immigration judge decides whether the child poses
a danger to the community.\14\ For the majority of children in ORR
custody, ORR has determined they are not a danger and therefore has
placed them in shelters, group homes, and in some cases, staff secure
facilities. For these children, a bond hearing is not beneficial.
---------------------------------------------------------------------------
\14\ Immigration judges also consider risk of flight. However, ORR
does not make a determination of flight risk for the purpose of
deciding whether a child is released. If an immigration judge offers an
opinion about a youth's risk of flight, ORR takes the judge's opinion
into consideration when assessing the child's placement and conditions
of placement, but the decision does not affect release.
The burden is on the requestor to demonstrate that the child can be
released because he or she is not a danger to the community. An
immigration judge's decision that the unaccompanied child is not a
danger to the community supersedes an ORR determination on that
question, unless the immigration judge's decision is overturned by the
Board of Immigration Appeals (BIA). However, even if an immigration
judge decides the child is eligible for bond (meaning the child does
not pose a danger to the community and need not remain in an ORR
facility for that reason), in all cases release from ORR custody cannot
occur until ORR has identified, evaluated and approved an appropriate
sponsor in accordance with Section 2 of this policy guide. An
---------------------------------------------------------------------------
immigration judge does not rule on any of the following:
release to a sponsor;
the unaccompanied child's placement or conditions of placement
while in ORR custody; or,
releasing the child on his or her own recognizance.
ORR also takes into consideration the immigration judge's decision in
the bond hearing about the youth's level of danger when assessing the
youth's placement and conditions of placement.\15\
---------------------------------------------------------------------------
\15\ Please see footnote above concerning risk of flight.
Although these hearings are known as ``bond hearings,'' ORR does not
require payment of any money in the event a court grants bond.
Requesting a Bond Hearing
A request for a bond hearing may be made by the child in ORR care, by a
legal representative of the child, or by parents/legal guardians on
their children's behalf. These parties may submit a written request for
a bond hearing to the care provider using the ORR form, Notice of Right
to Request a Bond Hearing, or through a separate written request that
provides the information requested in the form. ORR provides the Notice
of Right to Request a Bond Hearing to UC in secure and staff secure
facilities.
A request for a bond hearing must minimally include:
The full name and alien registration number (``A number'') of
the child;
If a parent or legal guardian, or an appointed legal
representative, is making the request, the parent/legal guardian's or
legal representative's name;
The location of the care provider facility;
The date of the request; and
The signature(s) of the requesting child, the parent/legal
guardian, and/or legal representative.
There is no filing fee to submit a request for a bond hearing to the
care provider.
A child (or his or her legal representative) may also request a bond
hearing by making an oral request in immigration court.
Bond Hearings Proceedings
Bond hearings are usually held at the immigration court where the
request for a bond hearing is filed.
If the immigration judge finds an unaccompanied child eligible for
bond, and ORR does not appeal, then ORR follows its sponsor assessment
and release procedures as described in Section 2 of this policy guide.
Appeals
Either party may appeal the immigration judge's decision to the BIA.
Because ORR cannot release a child until it identifies a suitable
sponsor, an immigration judge's finding that the unaccompanied child is
not a danger to the community does not necessarily result in a release
of the child while an appeal is pending.
Age Outs
If an unaccompanied child becomes 18 years old during the pendency of a
bond hearing or bond hearing appeal, ORR forwards the request for a
bond hearing and any relevant information to the local DHS/ICE Office
of Chief Counsel's office.
Further Requests for Bond Hearing
If an immigration judge (or BIA, when appealed) determines that an
unaccompanied child is ineligible for bond, such decision is final
unless the child can demonstrate a material change in circumstance to
support a second request for a bond hearing.
Revised 07/19/17
______
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.
Over the course of the past year, the Finance Committee has taken
bipartisan action to tackle a range of health-care challenges,
leveraging collaboration and consensus to advance common-sense
solutions for seniors and working families. Our pharmacy benefit
manager reforms would modernize Medicare's prescription drug benefits,
driving down costs at the pharmacy counter and netting billions in
savings for taxpayers. Moreover, the committee's mental health
proposals would build on previous efforts to shore up patient access to
critical services, especially in rural communities.
These policies received nearly unanimous support from across this
dais, all through regular order. Your department and its subagencies,
Mr. Secretary, have offered essential technical assistance throughout
these processes. That support has ensured alignment between our
legislation and its intended goals, and I thank you for that.
As we move forward, further action on these overdue, patient-
focused proposals must become an urgent priority not just for our
committee, but also for the administration. We have a responsibility to
patients, community pharmacies, and front-line health-care providers to
deliver on these commitments, regardless of policy differences on other
fronts.
The President's budget request, unfortunately, falls severely short
of that aim. On prescription drug affordability, for instance, the
document makes virtually no mention of the robust bipartisan, bicameral
efforts to reform PBM practices, instead opting to double down on price
control policies that polarize members in both chambers.
Bipartisan bills in the Senate and House would address unintended
consequences spurred by the Inflation Reduction Act's pricing
provisions, particularly for patients with rare diseases, who will
likely see fewer treatment options under the law. Rather than embrace
these avenues for viable reform, however, the budget seeks to expand
the program's scope, with no attempt at improved transparency,
certainty, or mitigation. Further, the President's budget request
affirms an overreaching mandate that will force more nursing homes to
close their doors and result in less access to home and community-based
services for Medicaid beneficiaries.
This document highlights divisions and misses vital opportunities
for productive, patient-driven partnerships with Congress.
We will continue engaging with your department on a host of health-
care hurdles that demand policymakers' attention. You have rightly
raised concerns, for instance, around the ongoing surge in medication
shortages, including for lifesaving therapies. The chairman and I
recently released a white paper outlining potential solutions to
prevent and mitigate this crisis, and we look forward to working with
HHS and CMS to develop legislation designed to achieve these goals.
We also stand ready to partner on proposals aligned with the
President's Cancer Moonshot, including by ensuring that seniors can
access innovations like multi-
cancer early detection screening tests. Earlier this Congress, I joined
Senator Bennet in reintroducing our bill to grant Medicare coverage for
these technologies, and bipartisan majorities in both chambers have
joined as cosponsors.
More broadly, while the administration erred in rescinding
regulations aimed at expediting access to medical breakthroughs, your
department could take a range of steps to restore patients' trust in
reliable coverage for medical devices, including by expanding and
enhancing the proposed pathway that CMS published last year.
Before closing, let me emphasize the importance of timely
communication with respect to the cyberattack on Change Healthcare.
While your department has recently taken steps to issue guidance and
flexibilities to insurers, providers, and contractors to mitigate the
effects of the hack, the over 2-week delay resulted in avoidable
uncertainty.
Already financially vulnerable rural hospitals and providers, with
little to no cash reserves, required immediate action by the
administration to ensure payrolls could be met and services could
continue without interruption.
In the coming days and weeks, HHS should continue to update members
and stakeholders on efforts to limit further disruption.
We have an obligation to build on longstanding legacies of
bipartisanship to bolster the clinician workforce, drive value-based
care, improve broken payment systems, and ensure long-term access to
telehealth.
With these joint goals in mind, thank you again for being here
today, Mr. Secretary, and thank you, Mr. Chairman.
______
Prepared Statement of Hon. Ron Wyden,
a U.S. Senator From Oregon
Today, the Finance Committee meets to discuss the year ahead for
health care in our country. Thank you, Secretary Becerra, for joining
us.
I'm going to start us off today with a little history lesson. Topic
one: drug prices. In July of 2020, Donald Trump said, and I quote:
``Since the day I took office, I have made reducing drug prices one of
my highest priorities.'' For 4 straight years Donald Trump complained
about high drug prices, did lots of finger pointing about the problem,
and repeatedly talked about how he was a great friend to seniors who
depend on Medicare. What did he accomplish over his 4 years? Exactly
nothing.
Fast forward to the Biden administration. From the time he took
office, President Biden made it clear from Day One that he was
committed to lowering drug prices and health-care costs for families.
Two years later, he was signing the Inflation Reduction Act into law.
For the first time, under that law, Democrats and President Biden
gave Medicare the authority to negotiate better drug prices. Now, most
Americans have access to free vaccines. We capped insulin costs for
seniors at $35 a month. The commercial market caught on.
We created price-gouging penalties to hold big pharma accountable
for high drug costs. They're already benefiting patients and taxpayers.
And there's more for us to do. For example, it's essential that we get
pharmacy benefit manager, or PBM, reforms across the finish line this
Congress to lower drug costs for patients and protect community
pharmacies.
Topic two: health insurance. In March of 2019, Donald Trump
tweeted: ``The Republican Party will become `The Party of Health Care!'
'' With the help of Senate Republicans, his number one health-care goal
was repealing the Affordable Care Act. Thankfully, he failed.
Under President Biden's leadership, Democrats boosted tax credits
for health insurance, saving millions of Americans an average of $800
per year on their coverage and expanding access to care. When you look
at President Biden's health-care budget for the upcoming year, it's
clear Democrats are committed to building on the progress we've already
made. There's a lot more work to do for the American people.
So, with all these health-care challenges in mind, the next
question is, what do Donald Trump and Republicans have planned for
health care? The American people are wondering, because not once during
their ACA ``repeal and replace'' crusades did they offer up a serious
replacement.
Seven years after his efforts to repeal the ACA crashed and burned,
nothing has changed. Trump is still saying he wants to repeal it, and
he still lacks a plan to take care of all the people whose health
coverage he'd rip away. And now he's even talking about gutting
Americans' hard-earned Social Security and Medicare benefits. No plan
for how to keep seniors out of poverty and illness either. That, folks,
in a nutshell is the Republican health-care plan: shred the health-care
programs countless Americans rely on, and pretend there won't be
disastrous consequences.
So in my view, there's a clear contrast for the American people to
observe on health care. Since the day President Biden took office, he's
been laser-focused on bringing down costs and improving care. But for
all Donald Trump's bluster on various health-care issues, the gap
between his promises on health care and his actual record is as deep as
Crater Lake.
Democrats made promises to the American people, and we delivered.
Finally, here's another reason to get my bipartisan tax deal with
Congressman Smith passed in the Senate, and immediately lift 400,000
kids out of poverty. Dr. Ben Hoffman--a doctor at Oregon's very own
OHSU and president of the American Academy of Pediatrics--has said that
there's an ``inextricable link between poverty and child health,'' and
that passing my bipartisan Child Tax Credit expansion is essential to
lift kids out of poverty and improve their health. I'm all in to get
that done.
When I say that 16 million kids from low-income families--
particularly families with more than one kid--will be better off if the
Senate passes this bill, the health and well-being of those children is
a core part of what I'm talking about. If you don't want to take my
word for it, listen to the American Academy of Pediatrics.
I look forward to hearing from Secretary Becerra about how
President Biden will continue to lower costs and improve care for more
American families.
______
Communications
----------
Center for Fiscal Equity
14448 Parkvale Road, Suite 6
Rockville, MD 20853
240-810-9268
fiscalequitycenter@yahoo.com
mbindner@umd.edu
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 2025 Budget
Request.
General Approach
For obvious reasons, this year will be more hectic than the last. The
budget and appropriations process need to be simple. To do this, pass a
consensus caretaker budget with two draft partisan supplemental bills,
one of which can be enacted during the Lame Duck Session or at the
beginning of the next Congress for the
President-Elect to sign upon taking office, depending on who wins.
If such a budget is enacted, use it as the basis for spending caps for
a new Budget Control Act. Make the targets realistic and self-enforcing
for purposes of Appropriations Committee allocations.
Contingencies
In the event the majority in the House shifts due to early retirements
or insurrection indictments, the Senate majority and the House minority
should have legislation ready to enact a Public Option, including
reconciliation instructions for the FY24 budget year. Please see the
attachment for details.
As any such change in control will only last through the special
election cycle, this should be the second priority. The first must be
amending the Electoral Count Act and the jurisdiction of the Ethics
Committees to provide for the enforcement of the Fourteenth and
Twentieth Amendments, including provisions for removing and related
disability for members and the President-elect.
The President's Budget addresses the following two top line points:
Lowers Health Care Costs, making permanent the expanded premium tax
credits that the Inflation Reduction Act extended, providing Medicaid-
like coverage to individuals in States that have not adopted Medicaid
expansion, paired with financial incentives to ensure States maintain
their existing expansions.
Protects and Strengthens Medicare, extending the solvency of the
Medicare Hospital Insurance (HI) trust fund indefinitely by modestly
increasing the Medicare tax rate on incomes above $400,000, closing
loopholes in existing Medicare taxes, and directing revenue from the
Net Investment Income Tax into the HI trust fund as was originally
intended.
Regarding lowering health-care costs, the President is forgetting his
promise to create a Public Option.
We disagree with the President on how to shore up the HI trust fund and
expand the Affordable Care Act. 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 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.
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.
The way to fully fund health care is through an employer-paid
subtraction value-added tax.
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
veteran's health care and overseas military and ocean deployments.
The President's budget cites PHARMA profits as a rationale for
increasing business income tax rates. He proposes raising Tax Rates for
Large Corporations.
Instead, we suggest eliminating Corporate Profits taxes and taxation of
business income on Form 1040 with a Subtraction VAT (with offsets for
employee and retiree health care) and a credit invoice tax on both
labor and profit. The combined rates of these taxes will burden both
profits and labor costs, raising much more money.
This tax will be levied for all income earned in the country of
production (for subtraction VAT) and of sale (Credit Invoice VAT). A
new agreement on rate uniformity for our proposed Asset VAT will
prevent rate shopping for stock trading (see the second attachment).
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.
Funding Orphan Drugs and the issue of PHARMA profits
PHARMA justifies its profits because it is burdened with high
development costs for new and orphan drugs. We renew our call for a
more ``corporate approach'' for government research and testing of new
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 16th of this year,
we repeated our proposal in this area for NIH to retain ownership in
any such drug and contract out its further development and manufacture.
Keeping ownership in public hands ends the need for drug companies to
charge extreme prices or increase prices for its existing formulary to
fund development.
PHARMA would still make reasonable profit, but the government would eat
the risk and sometimes reap the rewards. NIH/FDA might even break even
in the long term, especially if large volume drugs which were developed
with government grants must pay back a share of basic research costs
and the attached profits, as well as regulatory cost.
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: 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 preexisting conditions and
mandates. The public option would then cover all families who are
rejected for either preexisting conditions or the inability to pay. In
essence, this is an expansion of Medicaid to everyone with a
preexisting 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 (were) under financial pressure as a result of the
pandemic, especially in the area of health-care costs, most especially
for seniors in nursing homes who are ``dual eligible.'' 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.
Asset VAT--The President's Fiscal Year 2023 Budget, June 7, 2022
There are two debates in tax policy: how we tax salaries and how we tax
assets (returns, gains and inheritances). Shoving too much into the
Personal Income Tax mainly benefits the wealthy because it subsidizes
losses by allowing investors to not pay tax on higher salaries with
malice aforethought.
Asset Value-Added Tax (A-VAT) is a replacement for capital gains taxes
and the estate tax. It will apply to asset sales, exercised options,
inherited and gifted assets and the profits from short sales. Tax
payments for option exercises, IPOs, inherited, gifted and donated
assets will be marked to market, with prior tax payments for that asset
eliminated so that the seller gets no benefit from them. In this
perspective, it is the owner's increase in value that is taxed.
As with any sale of liquid or real assets, sales to a qualified broad-
based Employee Stock Ownership Plan will be tax free. This change would
be counted as a tax cut, giving investors in public stock who make such
sales the same tax benefit as those who sell private stock.
The repeal of corporate profits taxes as part of the creation of a
subtraction value-added taxes and repeal of capital gains taxes in the
United States will lead to their repeal worldwide. If Asset Value-Added
Taxes are adopted, the rate should be negotiated so that investors who
are able do not market shop for the lowest rate. The recent OECD
compact on minimum rates is an example of how tax cooperation on
capital can work for other types of asset taxation. This tax will end
Tax Gap issues owed by high-income individuals. The base 20% capital
gains tax has been in place for decades. The current 23.8% rate
includes the ACA-SM surtax), while the Biden proposal accepted by
Senator Sinema is 28.8%. Our proposed Subtraction VAT would eliminate
the 3.8% surtax. This would leave a 25% rate in place.
Settling on a bipartisan 22.5% rate (give or take 0.5%) should be
bipartisan and carried over from the capital gains tax to the asset
VAT. A single rate also stops gaming forms of ownership. Lower rates
are not as regressive as they seem. Only the wealthy have capital gains
in any significant amount. The de facto rate for everyone else is zero.
With tax subsidies for families shifted to an employer-based
subtraction VAT, and creation of an asset VAT, taxes on salaries could
be filed by employers without most employees having to file an
individual return. It is time to TAX TRANSACTIONS, NOT PEOPLE!
The tax rate on capital gains is seen as unfair because it is lower
than the rate for labor. This is technically true; however, it is only
the richest taxpayers who face a marginal rate problem. For most
households, the marginal rate for wages is less than that for capital
gains. Higher income workers are, as the saying goes, crying all the
way to the bank.
In late 2017, tax rates for corporations and pass-through income were
reduced, generally, to capital gains and capital income levels. This is
only fair and may or may not be just. The field of battle has narrowed
between the parties. The current marginal and capital rates are seeking
a center point. It is almost as if the recent tax law was based on
negotiations, even as arguments flared publicly. Of course, that would
never happen in Washington. Never, ever.
Compromise on rates makes compromise on form possible. If the
Affordable Care Act non-wage tax provisions are repealed, a rate of 26%
is a good stopping point for pass-through, corporate, capital gains and
capital income.
A single rate also makes conversion from self-reporting to automatic
collection through an asset value-added tax levied at point of sale or
distribution possible. This would be both just and fair, although
absolute fairness is absolute unfairness to tax lawyers because there
would be little room to argue about what is due and when.
Ending the machinery of self-reporting also puts an end to the Quixotic
campaign to enact a wealth tax. To replace revenue loss due to the
ending of the personal income tax (for all but the wealthiest workers
and celebrities), enact a Goods and Services Tax. A GST is inescapable.
Those escapees who are of most concern are not waiters or those who
receive refundable tax subsidies. It is those who use tax loopholes and
borrowing against their paper wealth to avoid paying taxes.
For example, if an unnamed billionaire or billionaires borrow against
their wealth to go into space, creating such assets would be taxable
under a GST or an asset VAT. When the Masters of the Universe on Wall
Street borrow against their assets to avoid taxation, having to pay a
consumption tax on their spending ends the tax advantage of gaming the
system.
This also applies to inheritors. No ``Death Tax'' is necessary beyond
marking the sale of inherited assets to market value (with sales to
qualified ESOPs tax free). Those who inherit large cash fortunes will
pay the GST when they spend the money or Asset VAT when they invest it.
No special estate tax is required and no life insurance policy or
retirement account inheritance rules will be of any use in tax
avoidance.
Tax avoidance is a myth sold by insurance and investment brokers. In
reality, explicit and implicit value-added taxes are already in force.
Individuals and firms that collect retail sales taxes receive a rebate
for taxes paid in their Federal income taxes. This is an
intergovernmental VAT. Tax withheld by employers for the income and
payroll taxes of their labor force is an implicit VAT. A goods and
services tax simply makes these taxes visible.
Should the tax reform proposed here pass, there is no need for an IRS
to exist, save to do data matching integrity. States and the Customs
Service would collect credit invoice taxes, states would collect
subtraction VAT, the SEC would collect the asset VAT and the Bureau of
the Public Debt would collect income taxes or sell tax-
prepayment bonds.
______
Commissioned Officers Association of the
U.S. Public Health Service
P.O. Box 189
Cheltenham, MD 20623
Phone: 301-731-9080
https://www.coausphs.org/
July 10, 2023
The Honorable Kay Granger The Honorable Rosa DeLauro
Chair Ranking Member
U.S. House U.S. House
Committee on Appropriations Committee on Appropriations
The Honorable Patty Murray The Honorable Susan Collins
Chair Vice Chair
U.S. Senate U.S. Senate
Committee on Appropriations Committee on Appropriations
Dear Chairs Granger and Murray, Ranking Member DeLauro, and Vice Chair
Collins:
We the undersigned former and acting Surgeons General are writing to
bring to your attention the effect that the $84 million rescission,
enacted in the Fiscal Responsibility Act, will have on the training and
operations of the U.S. Public Health Service (USPHS) Ready Reserve and
Public Health Emergency Response Strike Team (PHERST) over the next 3
years.
If additional funds are not provided in the fiscal year 2024
appropriations bill, 206 officers and civilians will be relieved of
duty and/or reassigned. This workforce reduction will have detrimental
effects on the nation's ability to rapidly respond to public health
emergencies.
Since 1798, the USPHS Commissioned Corps has protected the health and
safety of the nation. Recently, USPHS Ready Reserve officers provided
direct support to the National Guard Bureau during COVID-19 pandemic;
they responded to the opioid crisis by training and assisting state and
local governments in the proper use of naloxone for the treatment of
drug overdoses; ensured evacuated Afghanis received proper medical care
during the Operation Allies Welcome Safe Haven and resettlement
missions; and met the health needs of vulnerable populations through
innovative readiness training missions.
We respectfully request that $48 million be provided in the FY24
appropriations bill for the USPHS Commissioned Corps Ready Reserve
Corps and PHERST ($20 million already requested in the President's
budget and an additional $28 million to restore the rescinded funds for
FY24). This funding will enhance the rapid response of the USPHS Ready
Reserve and Public Health Emergency Response Strike Teams to meet the
nation's public health needs.
Thank you for considering this request.
Respectfully,
(In order of term served)
Vice Admiral Antonia Novello, M.D.
14th Surgeon General of the United States
Rear Admiral Robert A. Whitney, D.V.M.
Acting
Rear Admiral Audrey Manley, M.D.
Acting
Admiral David Satcher, M.D.
16th Surgeon General of the United States
Rear Admiral Kenneth P. Moritsugu, M.D.
Acting
Vice Admiral Richard Carmona, M.D.
17th Surgeon General of the United States
Rear Admiral Steven Galson, M.D.
Acting
Rear Admiral Donald L. Weaver, M.D.
Acting
Vice Admiral Regina Benjamin, M.D.
18th Surgeon General of the United States
Rear Admiral Boris Lushniak, M.D.
Acting
Rear Admiral Sylvia Trent-Adams, R.N., Ph.D.
Acting
Vice Admiral Jerome Adams, M.D.
20th Surgeon General of the United States
______
NumbersUSA
1201 Wilson Boulevard, 27th floor
Arlington, VA 22209
703-816-8820
www.NumbersUSA.com
March 13, 2024
Distinguished Chair, Ranking Member, and all Members of the Committee,
it is a privilege to have the opportunity to speak out against one of
the largest scandals in the Biden Administration. It is a scandal that
trades childhood for cheap labor. It is a tragedy that transforms
children from a shining future into present day heartbreaking
headlines. The reason for this turn of events is no mystery. The New
York Times has a series of reports that make clear precisely who is to
blame for the exploitation of children: Secretary of Health and Human
Services Xavier Becerra. This statement for the record will catalog his
actions for posterity.
In February 2023, The New York Times wrote (emphasis added):
``His (Becerra) 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.
. . .
Concerns piled up in summer 2021 at the Office of Refugee
Resettlement, the H.H.S. division responsible for unaccompanied
alien children (UAC). 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.''\1\
---------------------------------------------------------------------------
\1\ Alone and Exploited, Migrant Children Work Brutal Jobs Across
the U.S., https://www.nytimes.com/2023/02/25/us/unaccompanied-migrant-
child-workers-exploitation.html.
In April of 2023, The New York Times continued their investigation of
---------------------------------------------------------------------------
child endangerment by the Biden Administration and Mr. Becerra:
``Again and again, veteran government staffers and outside
contractors told the Health and Human Services Department,
including in reports that reached Secretary Xavier Becerra,
that children appeared to be at risk. The Labor Department put
out news releases noting an increase in child labor. Senior
White House aides were shown evidence of exploitation, such as
clusters of migrant children who had been found working with
industrial equipment or caustic chemicals.
. . .
Under the law, the Department of Health and Human Services is
responsible for vetting sponsors to ensure they will provide
for children's well-being and protect them from trafficking or
exploitation. But as shelters filled with children, the
department began loosening some vetting restrictions and urging
case managers to speed the process along.
Longtime H.H.S. staff members complained that the changes
endangered children. White House aides and administration
officials grew exasperated, believing that these workers were
clinging to protocols that kept children in shelters when it
was better for them to be in a home with an adult.
``It was maddening,'' said Vivian Graubard, a White House
adviser who worked with Ms. Rice on migrant child issues.
At least five Health and Human Services staff members filed
complaints and said they were pushed out after raising concerns
about child safety.
Jallyn Sualog was the most senior career member of the H.H.S.
division responsible for unaccompanied migrant children when
Mr. Biden took office. She had helped build the program after
the passage of the 2008 law and, as a lifelong Democrat, had
celebrated Mr. Biden's win.
But soon, she said, she began to hear reports that children
were being released to adults who had lied about their
identities, or who planned to exploit them.
She warned her bosses in a 2021 email, ``If nothing continues
to be done, there will be a catastrophic event.'' She continued
to email about situations she described as ``critical'' and
``putting children at risk.''\2\
---------------------------------------------------------------------------
\2\ As Migrant Children Were Put to Work, U.S. Ignored Warnings,
https://www.nytimes.com/2023/04/17/us/politics/migrant-child-labor-
biden.html.
If you are wondering why Secretary Becerra would push vulnerable
children into domestic trafficking, an HHS spokesperson explained
---------------------------------------------------------------------------
(emphasis added):
``An H.H.S. spokeswoman said the department was aware that some
migrant children worked long hours because they are under
intense pressure to earn money, but the agency's legal
responsibility for children ends once they are released. Still,
the department is working to provide a few months of case
management to all unaccompanied migrant children, she said.
For now, most children released to sponsors have little support
aside from an H.H.S. hotline. According to internal documents
obtained by The Times, reports of trafficking to that hotline
increased by about 1,300 percent over the past 5 years.''
So the real motivation for a speedy assembly line of child placement
was to get the children out of the zone of legal interest for HHS. They
passed children to known traffickers so the kids would no longer be
their legal problem. Secretary Becerra would have brought more honor to
himself and the government if he had just left the children on the
doorstep of a known, trustworthy church or nonprofit.
This scandal cannot be overstated. Mr. Becerra has placed the political
interest of his boss, President Biden, over the welfare of the children
he is duty-bound to protect. The cost of Secretary Becerra's decision
has been staggering.
A Florida Grand Jury convened to investigate treatment of unaccompanied
alien children (UAC) and was horrified by what they found:
``If any resident of Florida exposed U.S.-born children to this
process, they would be justifiably arrested for child neglect
or worse. We do not think children should be less-protected
simply because they were born outside our borders and brought
here by a government agency.''\3\
---------------------------------------------------------------------------
\3\ THIRD PRESENTMENT OF THE TWENTY-FIRST STATEWIDE GRAND JURY
REGARDING UNACCOMPANIED ALIEN CHILDREN (UAC), https://acis-
api.flcourts.gov/courts/68f021c4-6a44-4735-9a76-5360b2e8af13/cms/case/
651d8f68-f322-4cd0-831f-74dc9b0d77a8/
docketentrydocuments/8437d6e2-1c46-4575-bd21-47de83302c61.
The Florida Grand Jury also observed a pattern of cover-up from
---------------------------------------------------------------------------
Secretary Becerra and his department:
``We stand in company with the United States Senate and House
members in being actively obstructed by this agency This
obfuscation extends beyond just ORR in the immigration context.
Last March, NBC News reported that Border Patrol agents and
officials, who had previously been responding to public record
and media inquiries about the number of border apprehensions
and conditions (including releasing videos), were subjected to
a gag order prohibiting any media requests or sharing data on
their own. We also learned that ORR actively discouraged its
employees, including case managers and those tasked with
conducting sponsor verifications, UAC interviews and post
release follow-up, and fingerprint and background checks, from
questioning the process even internally; some were transferred,
some terminated, some threatened, and some smeared simply for
not processing the UAC as quickly as possible. One was fired
for reporting a case of suspected human trafficking (of over
100 UAC shipped off to a single house in Texas) to a government
hotline because her ORR superiors refused to investigate the
matter. One facility went so far as to set up a ``reporting
station'' for employees to bring their concerns to; it was
purported to be staffed with FBI agents, but was later learned
to have simply other ORR employees--the agency was reporting
itself, to itself. In one memorable instance, a federal
employee was told by an ORR attorney to stop asking questions
about potentially unsafe sponsors because doing so caused
delay, and [W]e only get sued for keeping them too long. We
don't get sued by traffickers. Are we clear?''
It is clear that there is a pattern from the top down to systematically
shuffle children in HHS custody to the first adult willing to take
them. This is, in part, a response to the overwhelming numbers that
have arrived at the border during the Biden Administration. However,
lack of resources does not excuse abuse. It was Secretary Becerra's
duty to follow the law and protect the children in his custody. Instead
he clearly prioritized the political standing of his Administration
over the safety and security of the children under his control.
In essence, Secretary Becerra shifted the cost of President Biden's
campaign rhetoric on immigration from the government to the children
they encouraged to enter illegally. And pay, the children have.
Marcos Cux, 14, was profiled in The New York Times:
``The belt caught the sleeve of Marcos's baggy jacket and
pulled him across the floor. Hard plastic teeth ripped through
his muscles, tearing open his forearm down to the bone. By the
time someone heard his screams and shut off the power, his arm
was limp, a deep triangular gash running down the length of it.
A rope of white tendons hung from his elbow to his wrist,
horrifying the workers who gathered around him. He understood
from their faces that something was badly wrong but didn't feel
any pain as the wound began gushing blood and he started to
lose consciousness.''\4\
---------------------------------------------------------------------------
\4\ The Kids on the Night Shift, https://www.nytimes.com/2023/09/
18/magazine/child-labor-dangerous-jobs.html.
---------------------------------------------------------------------------
Marcos is one of the more fortunate:
``But as more children come to the United States to help their
families, more are ending up in these plants. Throughout the
company towns that stud the `broiler belt,' which stretches
from Delaware to East Texas, many have suffered brutal
consequences. A Guatemalan eighth grader was killed on the
cleaning shift at a Mar-Jac plant in Mississippi in July; a
federal investigation had found migrant children working
illegally at the company a few years earlier. A 14-year-old was
hospitalized in Alabama after being overworked at a chicken
operation there. A 17-year-old in Ohio had his leg torn off at
the knee while cleaning a Case Farms plant. Another child lost
a hand in a meat grinder at a Michigan operation.''
Thanks to the feckless assembly line policies of Secretary Becerra,
child trafficking in the United States is a billion dollar industry for
transnational criminal organizations.\5\ It is also helping
unscrupulous employers by providing a steady stream of vulnerable
labor.
---------------------------------------------------------------------------
\5\ Smuggling Migrants at the Border Now a Billion-Dollar Business,
https://www.nytimes.
com/2022/07/25/us/migrant-smuggling-evolution.html.
The examples of the booming Biden child labor market are voluminous,
---------------------------------------------------------------------------
but just a few examples will illustrate the impact:
March 6, 2024: OWNER OF 20 HWY 55 BURGERS, SHAKES & FRIES
RESTAURANTS ENTERS COMPLIANCE AGREEMENT, PAYS $11K IN PENALTIES FOR
CHILD LABOR VIOLATIONS.\6\
---------------------------------------------------------------------------
\6\ OWNER OF 20 HWY 55 BURGERS, SHAKES & FRIES RESTAURANTS ENTERS
COMPLIANCE AGREEMENT, PAYS $11K IN PENALTIES FOR CHILD LABOR
VIOLATIONS, https://www.dol.gov/newsroom/releases/whd/whd20240306.
---------------------------------------------------------------------------
February 28, 2024, US DEPARTMENT OF LABOR OBTAINS COURT JUDGMENT
ORDERING IDAHO FALLS RESTAURANT TO PAY $319K FOR ILLEGAL TIP SHARING,
CHILD LABOR, OVERTIME VIOLATIONS.\7\
---------------------------------------------------------------------------
\7\ https://www.dol.gov/newsroom/releases/whd/whd20240228-0.
---------------------------------------------------------------------------
Feb. 13, 2024, ADMINISTRATIVE LAW JUDGE UPHOLDS US DEPARTMENT OF
LABOR FINDINGS OF CHILD LABOR VIOLATIONS, $38K FINE FOR UPSTATE NEW
YORK WATER PARK.\8\
---------------------------------------------------------------------------
\8\ https://www.dol.gov/newsroom/releases/whd/whd20240223.
---------------------------------------------------------------------------
Feb. 21, 2024, US DEPARTMENT OF LABOR SEEKS INJUNCTION TO STOP
USE OF `OPPRESSIVE CHILD LABOR' BY FAYETTE JANITORIAL SERVICE AT MEAT
PROCESSING FACILITIES.\9\
---------------------------------------------------------------------------
\9\ https://www.dol.gov/newsroom/releases/whd/whd20240221-
0#::text=SIOUX%20CITY%2C
%20IA%20%E2%80%93%20The%20U.S.,while%20the%20department%20continues%20it
s.
---------------------------------------------------------------------------
Feb 7, 2024, ROOFING CONTRACTOR PAYS $117,175 PENALTY AFTER 15-
YEAR-OLD'S FATAL FALL AT ALABAMA WORK SITE.\10\
---------------------------------------------------------------------------
\10\ https://www.dol.gov/newsroom/releases/whd/whd20240207.
---------------------------------------------------------------------------
Feb 6, 2024, US DEPARTMENT OF LABOR FINES MICHIGAN POPEYES
FRANCHISE $48K; RESTAURANT ALLOWED CHILDREN TO WORK HOURS THAT VIOLATE
CHILD LABOR LAWS.\11\
---------------------------------------------------------------------------
\11\ https://www.dol.gov/newsroom/releases/whd/whd20240206-0.
---------------------------------------------------------------------------
Feb. 1, 2024, US DEPARTMENT OF LABOR INVESTIGATION FINDS
PENNSYLVANIA EMPLOYMENT SERVICE AGENCY EQUUS WORKFORCE SOLUTIONS
VIOLATED FEDERAL CHILD LABOR LAWS.\12\
---------------------------------------------------------------------------
\12\ https://www.dol.gov/newsroom/releases/whd/whd20240201.
Keep in mind, this is just a list of Department of Labor completed
investigations for March and February of this year. To list all
publicly available examples of child labor occurring in the United
States today would require expanding beyond the 10 page limit for
---------------------------------------------------------------------------
submissions for the record.
As this distinguished Committee and the Congress as a whole considers
the FY25 budget request from Secretary Becerra, they should keep in
mind the source. This is a man who has for over 3 years presided over
what has functioned as taxpayer-sanctioned child trafficking, leading
to the exploitation and death of innocent children.
Secretary Becerra has acted knowingly to pursue policies he was warned
would place children in dangerous situations where they would be forced
into hard labor. Some of these children have been killed and others
have been mutilated. Secretary Becerra has also been defiant in
retaliating against whistleblowers opposed to child endangerment, and
he has persisted in obfuscating and stonewalling any investigations
into his policies.
With all of this in mind, Secretary Becerra's budget must include clear
safeguards for the treatment of children entrusted into his custody.
Not one cent of taxpayer money should arrive in Secretary Becerra's
coffers without strings attached that ensure U.S. taxpayers are not
complicit in child exploitation.
If you can judge a society by how it treats children, then the United
States is worthy of severe condemnation at the moment. We need to unite
to stop this senseless child exploitation. This includes requiring HHS
to only deliver unaccompanied alien children to their parents or family
members verified by medical means or certified and retained
documentation, HHS should not deliver children to aliens already in the
country illegally.
Additionally, it makes no sense for vulnerable children to be placed
with sponsors who already have multiple children in their custody. HHS
has regularly placed children with strangers who already have sponsored
multiple children. This is clearly placing the children at risk of
exploitation.
Unless the Senate wants to provide a blank check to a Department with a
documented history of child abuse and cosign the calamity unfolding
under Secretary Becerra, it needs to rein him in and implement policies
to protect the children he has neglected.
James Massa
CEO
______
Reserve Organization of America
1 Constitution Avenue, NE
Washington, DC 20002-5618
www.roa.org
STATEMENT OF MAJ. GEN. JEFFREY E. PHILLIPS, U.S. ARMY (RET.)
The Reserve Officers Association of the United States, now doing
business as the Reserve Organization of America, is a military service
organization incorporated under Internal Revenue Service Code section
501(c)(19), and comprising all ranks of service members, veterans, and
family members of our nation's eight uniformed services separated under
honorable conditions. ROA is the only national military service
organization that solely and exclusively supports the reserve
components.
ROA was founded in 1922 by General of the Armies John ``Black Jack''
Pershing, during the drastic reductions of the Army after World War I.
It was formed to support a strong national defense and focused on the
establishment of a corps of reserve officers who would be the heart of
a military expansion in the event of war. Under ROA's 1950
congressional charter, our purpose is unchanged: To promote the
development and execution of policies that will provide adequate
national defense. We do so by developing and offering expertise on the
use and resourcing of America's reserve components.
Executive Director:
Maj. Gen. Jeffrey E. Phillips, U.S. Army (Ret.) 202-
646-7701
Director, Legislation and Military Policy:
Matthew L. Schwartzman 202-646-7713
_______________________________________________________________________
DISCLOSURE OF FEDERAL GRANTS OR CONTRACTS
The Reserve Officers Association of the United States, now doing
business as the Reserve Organization of America, has not received any
grants, contracts, or subcontracts from the federal government in the
past 3 years.
CURRICULUM VITAE
Jeff Phillips became the executive director of the Reserve Organization
of America (ROA) on December 8, 2014.
Now retired from the U.S. Army, Major General Phillips last served as
the deputy commanding general (U.S. Army Reserve) of the Army's
Training and Doctrine Command, at Fort Eustis, VA. In this position, he
was responsible for ensuring that the Army Reserve's requirements and
capabilities were reflected in Army training and training doctrine.
His decorations include the Distinguished Service Medal, two Legions of
Merit, two Bronze Star medals and the Army Parachutist Badge.
Chairman Wyden, Ranking Member Crapo, and distinguished members of the
Senate Committee on Finance, on behalf of the Reserve Organization of
America (ROA), the only national military organization that solely and
exclusively supports the uniformed services' reserve components, thank
you for the opportunity to submit a statement for the record on the
Fiscal Year (FY) 2025 budget request for the Department of Health and
Human Services (HHS).
HHS' FY 2025 budget request is significant, aiming at $130.7 billion in
discretionary and $1.7 trillion in mandatory proposed budget
authority.\1\
---------------------------------------------------------------------------
\1\ https://www.hhs.gov/about/budget/fy2025/index.html.
However, despite HHS advocating for needed benefits, programs, and
authorities for the Ready Reserve Corps (RRC) of the U.S. Public Health
Service (USPHS) in its FY 2025 Justification of Estimates for
Appropriations Committees, its FY 2025 budget request does not include
---------------------------------------------------------------------------
any resources to sustain the USPHS RRC.
In alignment with Resolution No. 23-02,\2\ Enact the Parity for U.S.
Public Health Service Ready Reserve Act, unanimously passed by our
members at our annual convention this past year, ROA urges the leaders
and members of this Committee to:
---------------------------------------------------------------------------
\2\ www.roa.org/resource/resmgr/legislation/resolution_no._23-
02_enact_t.pdf.
1) Ensure $28 million in funding is included in HHS' FY 2025
budget to sustain the USPHS RRC; and
2) Support S. 2297, the Parity for Public Health Service Ready
Reserve Act.
Despite a rich history dating back to 1798, the USPHS did not have a
functional RRC until the March 27, 2020, signing of Public Law No: 116-
136, the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
The USPHS RRC program, endorsed by 12 former and acting Surgeons
General,\3\ is part of a substantial modernization effort to enhance
the USPHS' capabilities and support the medical readiness of its
uniformed services counterparts. In particular, the USPHS RRC meets the
current challenges of maintaining the nation's health security by:
---------------------------------------------------------------------------
\3\ https://www.coausphs.org/common/Uploaded%20files/
Ready%20Reserve%20Legislation/Letter%20from%20SGs.pdf.
Supporting the USPHS' capacity to respond to
regional, national, and global health emergencies.
Improving access to health services and qualified
health professionals for the Total Force.
Preserving clinical care positions for USPHS Regular
Corps officers by maintaining a surge capability of personnel available
for deployment without jeopardizing the service of clinicians in hard-
to-fill roles.
Enabling access to highly specialized skill sets that
would be impractical in full-time active duty positions.
Providing an additional avenue of service for
mission-driven clinical and public health professionals who cannot
commit to a full-time position in the USPHS Regular Corps but can
provide a full-time capability.\4\
---------------------------------------------------------------------------
\4\ https://www.usphs.gov/ready-reserve.
SEC. 3214 of the CARES Act was successful in providing a preliminary
---------------------------------------------------------------------------
framework for the proper and effective usage of the USPHS RRC.
However, it failed to provide the RRC with a codified structure and
access to the proper ``tools'' for recruiting and retaining qualified
talent, including:
DUAL COMPENSATION
Under current law, workers cannot receive payment for two
separate federal jobs. While an exemption is granted for a
reserve component member of an armed force, it is not for a
reserve component member of a uniformed service.
As a result, USPHS RRC officers cannot work for the federal
government for their civilian job.
LEAVE
USPHS officers must be available for deployment or for
emergencies on extremely short notice. They are available for
activation 24 hours a day, 7 days a week.
The number of public health and emergency response missions
executed by the USPHS has increased by 44 percent over the last
decade.
Between 2013 and 2019, the USPHS deployed over 7,800 officers
for a cumulative total of over 139,000 deployment days.
Between 2020 and 2023, the USPHS deployed its officers over
6,400 times in support of over 1,000 missions, contributing to
187,000 deployment days.
As USPHS officers have more frequent and longer deployments
(responding to urgent public health demands across the nation)
leave becomes even more necessary to allow officers respite
time to recover and recuperate physically and psychologically.
However, leave time is important not just for rest and
recuperation, but also for emergencies and special needs.
Providing USPHS officers with the same leave opportunities as
those in the other uniformed services goes beyond parity. It
will also improve morale and officer performance, formally
recognize the pressures faced by USPHS officers in the line of
duty and provide USPHS officers with the means to meet the
needs of their personal life.
Several examples of leave not currently offered to officers of
the USPHS Commissioned Corps and its RRC include:
Parental leave (including primary and
secondary caregiver leave)
Convalescent maternity leave
Court appearance leave
Emergency leave
Child support leave
Marriage leave
Graduation leave
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Source: https://www.hhs.gov/sites/default/files/fy-2025-budget-
in-brief.pdf
TRICARE RESERVE SELECT, TRICARE DENTAL, AND TRICARE RETIRED RESERVE
Despite currently serving and retired members of the USPHS'
Regular Corps having access to TRICARE, members of the USPHS
RRC do not.
Extending TRICARE medical and dental coverage to currently and
formerly serving members of the USPHS RRC would show that the
government values all contributions of all the uniformed
services' and is willing to invest in the health of their
public health officers.
This will also ensure that all RRC officers receive healthcare
coverage, regardless of their civilian employment status.
TRICARE LINE OF DUTY CARE
The USPHS RRC is the only component of a uniformed service that
does not receive healthcare coverage for injuries sustained
when staying overnight before or during inactive-duty training
or while on funeral duty.
For example, a USPHS RRC officer would not receive healthcare
coverage in the following situation:
A USPHS RRC officer does their weekend inactive duty
training (IDT) at a site several hours away from their home.
The officer travels on a Friday (before training starts on
Saturday morning) and spends the weekend in a hotel. If the
officer sustains an injury (due to no fault of their own)
sometime Friday, the officer still would not be covered for any
healthcare associated with the injury. This would also apply if
the injury were to occur sometime Saturday night after IDT.
If an identical fact pattern occurred with a reserve component
member of an armed force, they would be provided with TRICARE
Line of Duty coverage.
TRICARE Line of Duty coverage pays for healthcare that is
needed due to an injury or illness that occurred during
required (and voluntary) military training days, such as IDT.
This disparity is especially egregious when considering that
the injury would likely have not been suffered if not for the
service requirement.
Further, additional danger may be posed to the officer if they
are forced to drive to and from their home to receive the care
they need.
GI BILL
USPHS RRC officers currently do not have access to vital educational
benefits, including the Post 9/11 GI Bill and Montgomery GI Bill
Selected Reserve (MGIB-SR). This is not the case for their armed forces
reserve component counterparts.
The good news is there is legislation that would resolve these
disparities and enable the USPHS Commission Corps to recruit, retain,
and mobilize RRC members: S. 2297, the Parity for Public Health Service
Ready Reserve Act.
ROA thanks Sen. Tammy Duckworth (IL) and you, Chairman Wyden, for your
sponsorship of S. 2297, which provides:
A codified reserve component structure.
Access to training exercises held by the other
uniformed services.
Access to medical and dental care under TRICARE
Reserve Select, the TRICARE dental program, and TRICARE Retired
Reserve.
Access to dual compensation and military leave
rights while deployed.
Access to the Post-9/11 GI Bill and MGIB-SR.
Representation on the Reserve Forces Policy
Board, a federal advisory committee making recommendations
directly to the Secretary of Defense to enhance reserve
component readiness.
$13.6 million in authorized annual funding for
programmatic sustainment.
The bad news is this legislation has not been signed into law.
As a result, the USPHS RRC has yet to achieve its desired end-strength
or realize its full capability.
This is presumably why funding for the USPHS RRC was eliminated by
Public Law No: 118-5, the Fiscal Responsibility Act (FRA).\5\ More
precisely, the FRA eliminated $84 million in funding over 3 FYs ($28
million per year) previously supplied by Congress via Public Law No:
117-2, the American Rescue Plan Act of 2021.\6\
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\5\ https://www.congress.gov/118/plaws/publ5/PLAW-118publ5.pdf.
\6\ https://www.congress.gov/117/plaws/publ2/PLAW-117publ2.pdf.
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To be clear:
ROA opposes the FRA's revocation of $84 million
in funding, which may eliminate the USPHS RRC.
ROA opposes HHS' exclusion of funding to sustain
the USPHS RRC in its FY 2025 budget request.
ROA supports restoring the USPHS RRC program with
$28 million in funding for FY 2025 (a .021% increase in HHS' FY
2025 discretionary budget authority request).
ROA supports S. 2297, the Parity for Public
Health Service Ready Reserve Act, which provides the USPHS RRC
with the tools it needs to further demonstrate its value and
potential to the Commissioned Corps, the Total Force, and the
nation.
That said, even without recruiting and retention tools, envisioned end-
strength, and a codified structure, the USPHS RRC has proven its
effectiveness and potential already by:
Augmenting the National Guard Bureau's medical
teams through delivering needed medical and public health
expertise during times of crisis, including the COVID-19
pandemic.
Supporting the Operation Allies Welcome safe
haven and resettlement missions to ensure evacuees received
medical care.
Providing medical care at the National Park
Service Yosemite clinic to avoid complete clinic closure.
Delivering no-cost healthcare to vulnerable
populations through the Department of Defense's innovative
readiness training missions.
As such, ROA urges your support for rapidly replenishing the response
capabilities of the UPSHS Commissioned Corps and Total Force medical
corps by restoring the USPHS RRC program with $28 million in funding
for FY 2025 and codifying S. 2297, the Parity for Public Health Service
Ready Reserve Act, in public law.
CONCLUSION
Thank you again for accepting ROA's statement for the record on HHS' FY
2025 budget request.
All too often military and veterans' law and policy are developed
without an understanding of or appreciation for the distinctions
between reserve and active duty service. The members of the Reserve and
National Guard invariably lose out. And so, too, their families. That
means America's military readiness loses out. We cannot afford that
loss.
ROA stands ready to provide added support to the issues covered in this
statement and looks forward to working with you further on other areas
of mutual interest.
______
Letter Submitted by Jesse P. Samluk, Ph.D.
Committee on Finance
United States Senate
219 Dirksen Senate Office Building
Washington, DC 20510
Re: The President's Fiscal Year 2025 Health and Human Services Budget
March 14, 2024
To Whom It May Concern:
I am writing this statement for the record regarding the President's
Fiscal Year (FY) 2025 Health and Human Services (HHS) Budget, with
respect to the hearing that was held on Thursday, March 14, 2024.
The dialog between Secretary Becerra and members on the Finance
committee surrounded various issues, including lowering prescription
drug costs, combating the opioid epidemic, cybersecurity, healthcare in
rural parts of the country, COVID-19, and unaccompanied minors at the
border. Some of these goals are laudable and should be pursued to the
fullest extent, and others are arguably solely for political gain.
Regardless of political views and other idealogues, there is one
important thing that Secretary Becerra and the rest of the committee
did not discuss; the Commissioned Corps of the United States Public
Health Service (USPHS). The lack of comment or any mere mention of this
vital service was as though this service branch never existed. Each
area of concern that the Secretary highlighted, a USPHS officer was
connected to in one way or another. However, it appears that all too
often this particular service is easy to forget about, even though the
service has been in existence since 1798--well before HHS was a
Department.
In that case, I will make it known that there are a multitude of issues
facing the service as a whole. Mainly, as a result of the Fiscal
Responsibility Act of 2023, funding for 2 components of the USPHS, the
Public Health Emergency Response Strike Team (PHERST) and the Ready
Reserve, were cut to the point that PHERST was all but discontinued,
and the Ready Reserve has also been impacted to the point that members
of that cadre are unsure if their component will survive. Training has
also been impacted for members of the Regular (Active) component.
While this is concerning for members of the service given financial
constraints and so forth, more importantly, the unfortunate wind down
of the PHESRT and Ready Reserve affects the areas and the people that
the USPHS serves. For example, the service was on the front lines of
HHS' COVID-19 response, which led the USPHS to experience its largest
deployment in history. The USPHS provided health care to our Native
American populations and served thousands of unaccompanied minors when
HHS was unable to obtain contractors. The Ready Reserve and PHERST
officers were some of the key players during these responses. Even with
all their success, out of the $1.7 trillion dollar budget for the
entirety of the HHS portfolio, there is $0 for PHERST, the Ready
Reserve, or Training (which is a Secretarial requirement stated in 42
U.S. Code Sec. 204a) Yes, $0. And this issue was not discussed--at all.
I'll close on this note. I know the Armed Forces provide a necessary
service to our country. So does the USPHS. Imagine, for example, if
NDAA discussions ``zeroed out'' the entire budgets of the Armed Forces
Reserves and National Guard. Of course every Congress member and
Secretary concerned would be very vocal about this situation. When it
comes to the USPHS, why is the same level of concern and urgency not
present?
Jesse P. Samluk, Ph.D., Esquire
LTJG, USPHS Ready Reserve
Assistant Engineer Officer
______
Transparency-Rx, American Pharmacy Cooperative, Inc.,
and the ERISA Industry Committee (ERIC)
March 13, 2024
The Honorable Ron Wyden The Honorable Mike Crapo
Chair Ranking Member
Senate Committee on Finance Senate Committee on Finance
219 Dirksen Senate Office Building 219 Dirksen Senate Office Building
Washington, DC 20510 Washington, DC 20510
Dear Chairman Wyden and Ranking Member Crapo,
On behalf of Transparency-Rx, APCI, and ERIC, we write collectively to
you to express continued support for the Senate Finance Committee's
(``Committee'') work and heightened attention on PBM reform as you
consider the Fiscal Year 2025 (FY25) Health and Human Services (HHS)
budget.
Our unique perspectives as employers, pharmacists, and pass-through,
transparent PBMs reflects our shared values and point view that
meaningful reform is both ripening and embraced in government and
commercial markets but must be prioritized.
Transparency-Rx \1\ is a non-profit coalition of pharmacy industry
experts led by transparent PBMs representing over 16 million covered
lives with operations, employers, patients, and plans in all fifty (50)
states. Transparency-Rx's members are committed to increasing
transparency in the prescription drug market and lowering costs.
Jointly, we offer these comments in the hopes that they are helpful to
the Committee in its work to rein in problematic practices of large
PBMs--a priority for both organizations' members. American Pharmacy
Cooperative, Inc.\2\ (``APCI'') is a member-owned cooperative
consisting of approximately sixteen hundred (1,600) independent
pharmacies in thirty (30) states and is committed to prescription drug
pricing transparency and lowering costs. ERIC is a national nonprofit
organization exclusively representing the largest employers in the
United States in their capacity as sponsors of employee benefit plans
for their nationwide workforces.
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\1\ Transparency-Rx: 20130 Lakeview Center Plaza, Ste. 400,
Ashburn, Virginia 20147, US.
\2\ American Pharmacy Cooperative, Inc.: 5601 Shirley Park Drive,
Bessemer, Alabama 35022.
We write to urge continued consideration of badly needed PBM reform and
transparency measures, at the administrative and legislative levels.
Without forceful action, contemplated in legislation including MEPA and
provisions in BETTER, Medicare beneficiaries and employers will
continue to face stifled choice and competition, degrading quality of
care and raising drug prices for America's seniors and working
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families.
It is now common knowledge that there is a high level of monopolization
or in the words of one of your Senate colleagues, ``cartels'' in the
commercial PBM marketplace, with the three biggest PBMs controlling
80% of the market. However, in Medicare, Part D, it is less well known
that levels of monopolization are far worse, nearing 100%. For
Medicare, this market-concentration and control has been disastrous for
seniors, pharmacists, and working families, driving unfettered use of
spread-pricing, junk fees, and increasingly other frowned upon
practices by big PBMs. Research shows, in fact, in seventy one percent
(71%) of Medicare Part D cases, net costs were highest from vertically
integrated PDPs to their vertically integrated pharmacies, meaning
that, for these cases, vertical integration likely have resulted in
higher costs to Part D and their enrollees.\3\ A second study focused
on Part D concluded despite Medicare being the largest buyer of
Eliquis, a leading cure preventing strokes, corporate spread pricing
PBMs hit seniors with the worst price increases, dramatically marking-
up what drug makers will sell it for. Moreover, large PBMs were found
to set drug prices higher when beneficiaries had out of pocket costs.
The study concluded large PBMs not manufacturers set drug prices for
patients at the counter, and created massive variability in drug prices
even when the benchmarks of acquisition cost set by CMS were stable.
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\3\ Chapter 2 of the MedPAC June 2023 report to Congress.
The pervasiveness and repetition of bad big PBM practices in Medicare,
commercial sectors, and Medicaid, call out a demand for clear and
comprehensive reform. Robust and actionable information on pricing,
rebates, fees, and discounts through the GPO, is essential for
employers, patients, and seniors to make informed decisions and
maintain a functioning and free market for prescription drugs. The
committee's initial introduction of MEPA and BETTER in 2023 are notable
as the Committee's combined legislative proposals set a pioneering
standard in the bubbling PBM reform debate. Specifically, the Committee
aimed to take concrete steps to ameliorate the burden of high list
prices that big PBMs have shifted onto patients, seniors and plans.
MEPA and BETTER would prohibit PBMs from linking rebates paid by
manufacturers to the list price of drugs, and instead implement a flat
service fee. This policy is otherwise known as ``delinking,'' and is
the very essence of a transparent approach, which transparent PBMs
along with local businesses already embrace. In a delinked or
transparent approach, fees are disclosed, reliable, and knowable, and
attempt to cure the drug affordability crisis in America, reducing
employers' health care costs on average by 15-20%. Without delinking in
Medicare and commercial markets, seniors and patients come second to
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PBM profits. We strongly support it in all markets.
Each of our organizations continues support the Finance Committee's
work to consider legislative proposals which increase transparency,
oversight, and enforcement of PBM practices, and we appreciate
heightened attention by the Biden Administration to PBM reform.
Despite increased Congressional interest, the prescription drug pricing
and reimbursement system remains opaque. If big PBM's bottom lines are
cushioned by higher drug prices extracted from the pockets of hard-
working Americans and seniors and job-creators, insurers or PBMs will
never lower drug prices, without an innovative policy proposal
advancing through Congress and the Executive Branch addressing their
misaligned incentives, market control, and many conflicts of interest.
We deeply appreciate your leadership. Please let us know if there is
anything we can do to help see your on-going impactful work succeed.
Sincerely,
Joseph M. Shields, Esq.
Managing Director
Transparency-Rx
20130 Lakeview Center Plaza, Ste. 400
Ashburn, VA
20147, US
Greg Reybold, Esq.
Director of Healthcare Policy & General Counsel
American Pharmacy Cooperative
5601 Shirley Park Drive
Bessemer, Alabama 35022
Melissa Bartlett
Senior Vice President, Health Policy
The ERISA Industry Committee
701 8th St., NW
Suite 610
Washington, DC 20001
Phone: (703) 304-9891
Fax: (202) 789-1120
[all]