[Senate Hearing 117-595]
[From the U.S. Government Publishing Office]
S. Hrg. 117-595
THE PRESIDENT'S FISCAL YEAR 2022 HHS BUDGET
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HEARING
BEFORE THE
COMMITTEE ON FINANCE
UNITED STATES SENATE
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
__________
JUNE 10, 2021
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[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Finance
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U.S. GOVERNMENT PUBLISHING OFFICE
51-268 PDF WASHINGTON : 2023
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COMMITTEE ON FINANCE
RON WYDEN, Oregon, Chairman
DEBBIE STABENOW, Michigan MIKE CRAPO, Idaho
MARIA CANTWELL, Washington CHUCK GRASSLEY, Iowa
ROBERT MENENDEZ, New Jersey JOHN CORNYN, Texas
THOMAS R. CARPER, Delaware JOHN THUNE, South Dakota
BENJAMIN L. CARDIN, Maryland RICHARD BURR, North Carolina
SHERROD BROWN, Ohio ROB PORTMAN, Ohio
MICHAEL F. BENNET, Colorado PATRICK J. TOOMEY, Pennsylvania
ROBERT P. CASEY, Jr., Pennsylvania TIM SCOTT, South Carolina
MARK R. WARNER, Virginia BILL CASSIDY, Louisiana
SHELDON WHITEHOUSE, Rhode Island JAMES LANKFORD, Oklahoma
MAGGIE HASSAN, New Hampshire STEVE DAINES, Montana
CATHERINE CORTEZ MASTO, Nevada TODD YOUNG, Indiana
ELIZABETH WARREN, Massachusetts BEN SASSE, Nebraska
JOHN BARRASSO, Wyoming
Joshua Sheinkman, Staff Director
Gregg Richard, Republican Staff Director
(II)
C O N T E N T S
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OPENING STATEMENTS
Page
Wyden, Hon. Ron, a U.S. Senator from Oregon, chairman, Committee
on Finance..................................................... 1
Crapo, Hon. Mike, a U.S. Senator from Idaho...................... 3
ADMINISTRATION WITNESS
Becerra, Hon. Xavier, Secretary, Department of Health and Human
Services, Washington, DC....................................... 4
ALPHABETICAL LISTING AND APPENDIX MATERIAL
Becerra, Hon. Xavier:
Testimony.................................................... 4
Prepared statement........................................... 45
Responses to questions from committee members................ 51
Crapo, Hon. Mike:
Opening statement............................................ 3
Prepared statement........................................... 100
Wyden, Hon. Ron:
Opening statement............................................ 1
Prepared statement........................................... 101
Communication
Center for Fiscal Equity......................................... 103
(III)
THE PRESIDENT'S FISCAL YEAR 2022
HHS BUDGET
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THURSDAY, JUNE 10, 2021
U.S. Senate,
Committee on Finance,
Washington, DC.
The hearing was convened, pursuant to notice, at 10:07
a.m., via Webex, in Room SD-215, Dirksen Senate Office
Building, Hon. Ron Wyden (chairman of the committee) presiding.
Present: Senators Stabenow, Cantwell, Menendez, Carper,
Cardin, Brown, Bennet, Warner, Cortez Masto, Warren, Crapo,
Thune, Burr, Portman, Toomey, Scott, Cassidy, Lankford, Young,
and Sasse.
Also present: Democratic staff: Shawn Bishop, Chief Health
Advisor; Eva DuGoff, Senior Health Advisor; and Joshua
Sheinkman, Staff Director. Republican staff: Kellie McConnell,
Policy Director; Gregg Richard, Staff Director; and Connor
Sheehey, Health Policy Advisor.
OPENING STATEMENT OF HON. RON WYDEN, A U.S. SENATOR FROM
OREGON, CHAIRMAN, COMMITTEE ON FINANCE
The Chairman. The committee will come to order. This
morning the Finance Committee welcomes Secretary Becerra to
discuss the President's 2022 budget proposal for the Department
of Health and Human Services.
There is much to talk about. I am going to begin with out-
of-
control prescription drug prices. Far too many Americans are
getting clobbered with every trip to pick up their medications
at the pharmacy window. The latest drug pricing news is the
approval of Aduhelm, a new medication for Alzheimer's disease,
one of the chronic diseases that now defines Medicare in the
modern day.
The drug's approval is controversial. There is little data
showing it actually does what the company says it will do.
Despite that, Aduhelm has an unconscionable list price of
$56,000 per year. Let us understand. It is not a cure like some
other recent breakthrough drugs have been. Patients could be on
Aduhelm for years at a time after their diagnosis, multiplying
the overall cost of treatment.
Setting aside the lack of clear evidence that this new
Alzheimer's drug actually works, medical science today is
clearly capable of miracles. The speedy development of highly
effective coronavirus vaccines is just one example. Every
single member of the Finance Committee welcomes and cheers
those advances. However, Americans are terrified by the status
quo on prescription drug pricing. Not only are too many
Americans foregoing or rationing their prescriptions, sky-high
drug prices could bust Americans' health-care budgets.
I am working now to update the Finance Committee's
prescription drug legislation from the last Congress, and I
welcome the ideas of all members of the committee. I believe
that it is long past time to give Medicare the authority to
negotiate better prices for prescription drugs on behalf of
more than 50 million seniors. Overwhelmingly, the American
people support this idea.
President Biden, during his speech in April to the Joint
Session, called on Congress to get it done. We are all hungry
for genuine medical breakthroughs, but, Senators, I would
simply say, what does it mean if the vast majority of Americans
cannot afford them?
A few other issues relating to the budget proposal and the
administration's priorities at the Department of Health and
Human Services. It is very welcome to see proposals on mental
health, because mental health care is a major priority for the
committee. We will have a lot more to say on mental health
during our Finance Committee hearings on that issue next week.
As I discussed with Secretary Becerra, I look forward to
continuing to work with his team on further implementation of
the CHRONIC Care Act, specifically expanding its benefits to
those who receive traditional Medicare. That way, the law that
we passed in 2018 will continually be able to update the
guarantee that is Medicare. I am also pleased that the
administration is continuing to make progress on the issue of
transparency and sunlight with respect to health-care prices.
It is important to make sure that progress is useful to
consumers as part of an overall effort to make health care more
affordable.
The budget also includes a landmark investment of $400
billion to expand access to home and community-based services
through Medicaid. This will be an absolute game-changer
resulting in more choices and better care for millions of
seniors and those with disabilities. Senator Casey and I, along
with a number of members of this committee, are working long
hours to get this done. We are also interested in building up
the care workforce to make sure those changes deliver on their
enormous potential.
Finally, I will close on the subject of child welfare. A
few years ago, this committee, on a bipartisan basis, put
together the Family First law. It was designed to help more
families stay together safely, instead of relying on foster
care. One of the key goals of the Finance Committee--and there
are a number of Senators here who were involved in this--was to
get more help to black and Native American families whose kids
are disproportionately represented in the child welfare system.
Unfortunately, the Trump administration gave short shrift
to the implementation of this law, and it is not living up yet
to its promise for a lot of those vulnerable youngsters. The
Biden administration has an opportunity to change that. It is
also proposing a new grant program that ought to help address
racial disparities in the foster care system.
So, we look forward very much to working with Secretary
Becerra. And there are a lot of kids and families who can
benefit tremendously from the Family First law.
With that, I will turn it over to our friend, Senator
Crapo, for his remarks, and then we will hear from the
Secretary.
[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, Mr. Chairman. And welcome,
Secretary Becerra.
The events of the past year have emphasized the importance
of the Department of Health and Human Services. Last year, the
efforts of HHS and its subagencies ensured safe access to
crucial health-care services, even at the height of the
pandemic, through telehealth expansion and other emergency
flexibilities. HHS also proved itself pivotal in partnering
with private-sector innovators to help bring several safe and
effective COVID-19 vaccines to the public in record time.
In the months ahead, the administration should work with
Congress to build on these successes, as well as to address
some of the challenges the past year has created or
exacerbated. Certain aspects of the President's budget request
seem aligned with these aims. The proposal describes the
concerted effort to build on our program integrity efforts to
tackle waste, fraud, and abuse, which harm taxpayers, patients,
and families. Program integrity represents a clear area of
common ground.
The budget request also highlights the importance of value-
based care, which will prove indispensable as we work to lower
health care costs while increasing health care.
Unfortunately, other aspects of the President's proposal
raise serious questions and concerns. Medicare trust fund
solvency remains a pressing crisis, jeopardizing benefits for
tens of millions of seniors. And yet, this budget request
proposes no meaningful policies to contain unsustainable
spending growth.
In fact, apart from outlining trillions of dollars in tax
increases and spending hikes, the budget proposal offers few
policy details at all. Much of the blueprint focuses on vague
references to agenda items with no meaningful discussion of how
to pay for them. These policies stray substantially from the
promise of unity and bipartisanship initially advertised by
this administration.
Proposals to lower the Medicare eligibility age, for
example, would likely crowd out private coverage without moving
the needle on access or affordability, all on the American
taxpayer's dime. The budget request also suggests using
Medicare dollars to expand Obamacare, just as we saw with the
original passage of the ACA more than a decade ago.
Rather than champion the market-based reforms that have
made Medicare Advantage and Part D such resounding success
stories for our Nation's seniors, the budget proposes a
convoluted price control scheme for prescription drugs that
would reduce access to life-saving cures in the years ahead.
For the roughly four in 10 seniors enrolled in Medicare
Advantage plans, the policies referenced in the budget request
could also mean drastic cuts which could jeopardize
supplemental benefits like dental and vision.
The document also affirms prioritization of $400 billion to
increase access to home and community-based services. Home and
community-based services are a key lifeline for scores of
Americans, and Congress should consider bipartisan policies to
expand availability. This should include ensuring that States
have the workforce necessary to meet demand. Unfortunately,
media reports suggest that this $400 billion may be used to
establish certain labor reforms that fail to address the gaps
in patient services that States have experienced for decades.
That being said, I am confident that we can find areas of
common ground, and I look forward to working with you, Mr.
Becerra and Mr. Chairman, to advance consensus-driven policies
on a range of health-care issues from telehealth to value-based
care.
Mr. Secretary, it is good to see you again, and I look
forward to your testimony and discussing these and other
vitally important issues with you today.
Thank you, Mr. Chairman.
[The prepared statement of Senator Crapo appears in the
appendix.]
The Chairman. Thank you, Senator Crapo.
Mr. Secretary, we look forward to your remarks.
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.
The Department of Health and Human Services is at the
center of many challenges facing our country today. The COVID-
19 pandemic has shed light on how health inequities and
inefficient Federal funding can leave communities vulnerable to
crisis. Now, more than ever, we must ensure that the Department
has the resources to achieve its mission and to build a strong
public health system and a healthier America.
For HHS, the budget proposes $131 billion in discretionary
budget authority and $1.5 trillion in mandatory funding. This
budget underscores the administration's commitment to prepare
the Nation for the next public health crisis, to expand access
to affordable health care, to address health disparities, to
tackle the opioid and other drug crises, and to invest in other
priority areas like maternal health, tribal health, and early
childhood education.
Now, we know the fight against COVID is not yet over, but
even as HHS works to beat this pandemic, we must also prepare
for the next public health challenge. To start, the budget
makes significant investments in our preparedness and response
capabilities, including by investing in the Strategic National
Stockpile and the public health workforce.
It provides a new mandatory funding stream for the
manufacture of medical countermeasures here at home to protect
Americans from future pandemics, and to create U.S. jobs. The
budget includes the largest fiscal year investment in the CDC
in almost 2 decades.
The budget reflects the President's commitment to expanding
access to quality, affordable health care for all Americans. It
builds on the groundbreaking reforms introduced in the American
Rescue Plan by permanently extending the enhanced premium
subsidies that put affordable health-care coverage within reach
for millions of Americans. The budget also expands access to
home and
community-based services under Medicaid, critical services that
allow older Americans and our loved ones with disabilities to
live independently in their homes and communities. And the
budget calls on Congress to take additional steps this year to
lower the cost of prescription drugs and further expand and
improve health coverage through additional benefits and public
coverage options.
Health care must be a right, not a privilege, and we will
work hard to ensure that families across the Nation are able to
secure the health care they need. As we work to expand access
to affordable health care and address the challenges of COVID-
19 and future pandemics, we need to address public health
crises that are already here, like violence in our communities
and climate change.
The President's budget increases funding to support
domestic violence survivors. It addresses gun violence by
doubling funding for firearm violence prevention research, and
it allows HHS to play a major role in the administration's
government-wide efforts to tackle the climate crisis by
supporting research and programs identifying the human health
impacts of climate change, and establishing an office of
climate change and health equity.
To ensure that HHS is equitably serving all Americans, the
budget invests in reducing maternal mortality and morbidity,
which disproportionately impact women of color. It builds on
the American Rescue Plan's State option to extend Medicaid
post-partum coverage. It funds a range of rural health-care
programs and expands the pipeline for rural health providers.
It includes a dramatic funding increase and advance
appropriations for the Indian Health Service. And it invests in
improving access to vital reproductive and preventative care
services through title X.
To support families and build the best possible future for
our children, the budget makes major investments to ensure
high-
quality child care is affordable to low- and middle-income
families, and to provide high-quality pre-K for all 3- and 4-
year-olds. We know our experiences as children shape who we are
as adults. Support for children in their childhood leads to
success in the future for all of us.
To address COVID-19's unprecedented acceleration of
substance abuse and mental health disorders, the budget
provides historic investments in SAMHSA to support research,
prevention, treatment, and recovery services. To support
innovation and research, the budget increases funding for NIH
by $9 billion, $6.5 billion of which will go to establish the
Advanced Research Project's Agency for Health, ARPAH, with an
initial focus on cancer and other diseases such as diabetes and
Alzheimer's. This major investment in Federal research and
development will leverage ambitious ideas to build
transformational innovation to help research and the
application and implementation of health breakthroughs.
Finally, to ensure our funds are used appropriately, the
budget invests in program integrity, including efforts to
combat fraud, waste, and abuse in Medicare, Medicaid, and
private insurance.
Mr. Chairman, I would like to close by recognizing the
women and men at HHS for their outstanding and tireless work
fighting COVID-19 to protect the health of their fellow
Americans. To build back a prosperous America, we need a
healthy America. We have taken important steps over the past
few months to beat back this pandemic, to expand access to
quality, affordable health care, to lower health premiums, and
to protect women's health at home and abroad.
President Biden's budget builds on that progress. Thank
you.
[The prepared statement of Secretary Becerra appears in the
appendix.]
The Chairman. Thank you very much, Mr. Secretary. We will
just go to 5-minute rounds on questions of members.
Now if only a fraction of seniors suffering from
Alzheimer's were prescribed Aduhelm, Medicare Part B spending
would double overnight. Seniors taking the drug would be asked
to pay more than $11,000 in co-insurance each year.
Now the President has called on the Congress to lower the
cost of prescription drugs through negotiations. And you, to
your credit--I just learned this at the Ways and Means
Committee--you basically said, ``Just give me the authority. I
want the authority. I want to go to work.''
Tell us, if you would, what kind of tools would be most
useful to you in using that authority? For example, one that
comes to my mind would be finding a way to get analysis of
prescription drugs to determine which ones were the best, and
you could factor that into your decision-making.
But I would be curious, because people say, ``All right, we
hear from Senators Medicare should negotiate.'' Tell us a
little bit about what kind of tools you would use, if you got
the authority you were talking about yesterday at the Ways and
Means Committee.
Secretary Becerra. Mr. Chairman, I can go on forever, but I
will keep it brief. I will tell you that one of the things that
is always helpful is oversight. The more we can have eyes on
what is going on to make sure the industry is doing the right
thing, that providers are handling these medications and
medical supplies properly, the more we know that we are getting
good bang for the buck for the American people. But there are
other ideas.
You have had ideas in your legislation that I know you are
trying again to move forward with. Maybe the negotiation of
drug prices. You can talk about providing drug rebates in the
event that a manufacturer tries to increase the price of a
prescription drug by more than inflation. There are any number
of good ideas that are out there.
As I said, give us the authority and we will go to work.
The Chairman. Very good. And you are going to get questions
from my colleagues about that as well.
I would like to talk to you about the CAHOOTS law. We, as
you know, were able to procure a billion dollars in Medicaid
funding for the States for an approach that I believe is a
pioneering strategy with respect to mental health.
We know that we have enormous challenges as it relates to a
lot of what goes on on the streets of this country, and the
CAHOOTS law has brought together mental health officials and
law enforcement officials in an unparalleled kind of way. What
happens is, when a 911 call comes in, a similar call is made to
the mental health people, and law enforcement people coordinate
what is the right kind of approach.
Now we are in the administrative stage, and I would be
interested in how the Department is preparing to work with the
States so these dollars can really get out there quickly for
something that I know in Eugene, OR--which has the original
CAHOOTS program, gave me the idea for it--is making a
difference. Your thoughts?
Secretary Becerra. Mr. Chairman, we want to get that out
there as quickly as possible. If I could just mention that, as
the Attorney General for California these last several years,
one of the things that we were trying to do is work closer with
all of our local law enforcement agencies, with our county
health offices and mental health offices, so we could do
exactly what you are trying to do through CAHOOTS.
And so we are getting ready to issue some guidance. We are
hoping to move quickly, fairly quickly, to issue those
regulations so we can get this on the ground and let that
mobility that you provide in CAHOOTS help us address the mental
health needs of so many Americans.
The Chairman. Let me ask you one other question. Especially
a couple of my colleagues are up here on the dais who joined me
some years ago in an effort to modernize employer-based health
coverage, which we all know came from the 1940s when there were
wage and price controls and just put it on the employer.
So these two gutsy colleagues, years ago--and I think they
will remember this--joined me in an effort to try to modernize
the system. We wanted to say that for those who wanted
employer-based coverage, great. But we ought to have more
options.
Now the American Rescue Plan made health insurance through
the exchanges more affordable. For many families, there are no
premiums. No matter what you make in a year, you are not paying
more than 8.5 percent of your income. But if your employer
offers you health insurance, different rules apply. Only when
the premiums for your employer's plan are 10 percent of your
income can you go to the exchanges to get affordable health
insurance. This is what is known as the ``health insurance
firewall.'' The practical effect is families paying thousands
more per year for their health insurance, when more affordable
options exist just out of reach.
So my question, Mr. Secretary--and I am not sure you have
been asked about this in public, but we have talked about it--
is, do you agree that the definition of ``affordability''
should be the same in the exchange and for employer coverage?
Secretary Becerra. You are right: I have not been asked
that question. And what I would tell you is that I think most
Americans would tell you they only have one definition of
affordability. Can they pull money out of their pocket and
afford the health care they need for their kids?
And so what I would tell you is, we have to work together
to make sure that we end up with a uniform response that says
affordability, regardless of how you define it in the statute
in one code section or another, has to mean it is affordable
for the American people.
And so I would tell you that we will work with you to make
sure that, at the end of the day, the definition is the one the
American people want to see.
The Chairman. Well, I think that is a very constructive
response. I think health insurance should not cost anyone more
than 8.5 percent of income, which is, in effect, what the
concept would be all about. And I look forward to working with
you on it.
Senator Crapo?
Senator Crapo. Thank you, Mr. Chairman.
Mr. Secretary, during your nomination hearing process, you
expressed support for State-led innovation advanced through
waivers. The two waivers receiving the majority of this
committee's attention are the 1115 and 1332 waivers, which
empower the States to better target their Medicaid and
individual marketplace populations.
Since your confirmation, the administration has taken the
unprecedented step of rescinding an 1115 waiver previously
granted to Texas. And as you know, there has been quite a bit
of furor over that. And that would have allowed the State of
Texas to expand its services for mental health coverage, in
addition to other things.
Like many of my colleagues on this committee, I believe
that this type of action raises profound concerns. I understand
that there is now attention to looking at the 1332 waiver that
Georgia recently received, and that the administration is
apparently moving into a pattern of reviewing existing waivers
to withdraw them.
First of all, is the administration currently considering
rescinding additional waivers? And do you believe that, if that
is the case, there should be a very open, transparent process
where the public is not only involved but aware of the
administration's efforts in these areas?
Secretary Becerra. Senator, thank you for the question. I
know this is an important one for the members, and it is also
an important one for us because these waivers are, as you said,
crucial. We want to make sure the goals of the Medicaid program
are fulfilled. We want to make sure that we get more people
into health coverage.
And when we review these waivers--again, waiving existing
law so that States can try to do it more innovatively and
hopefully save money and get more people coverage and care--we
want to make sure that is the ultimate goal. And so, when we
look at some of these waivers, or we put any on hold, it is
because we want to make sure that the goals of getting more
people covered at a better price are being achieved.
And we are currently in discussions with the State of
Texas--also with the State of Georgia--and we are working
closely with the State of Texas. They are in the process of
resubmitting a waiver request. They have a waiver that exists
today that still runs until probably about mid-next year. And
so we are going to make sure that we are working with States
who want to innovate to make sure that, if they need a waiver
or have a waiver, that we can continue forward.
Senator Crapo. Does the administration intend to outline
its authority for these reviews and provide the opportunity for
public comment and involvement and awareness of what the
rationale of the agency's actions are?
Secretary Becerra. A great question. I think when we had
our discussion, I mentioned to you that we are looking at
transparency and accountability first and foremost. So if there
is a notice and comment period so that everyone--stakeholders,
the consumers--have a chance to make a comment about a proposed
waiver, we want everyone to be able to weigh in so when we make
a decision on granting a waiver, it is based on all of the
information necessary.
Accountability--we want to make sure that, at the end of
the day, when you are talking billions, or in many cases tens
of billions of dollars, that it is used properly. Because these
are taxpayers who are helping these States move forward with
their innovative projects.
Senator Crapo. Well, thank you.
I would like to move to the Medicare trust fund. The Social
Security Act, as you know, established the Medicare board of
trustees to oversee the financial operations of the trust fund.
And you are a member of that board. The Medicare trustees'
report is 71 days late. As a member of the board, do you know
what the revised exhaustion date is of the hospital insurance
trust fund?
Secretary Becerra. Senator, I know that there have been
revisions in the past on the date. We are now being told that
it is imminent in the next several years. We will find out soon
if there have been any adjustments. But the most important
thing here is that we have to work together to continue
Medicare moving forward for the tens of millions of seniors who
depend on it.
Senator Crapo. Do you have any information about when the
trustees' reports will be released?
Secretary Becerra. Let me get back to you on that, because
I have not been given any particular date.
Senator Crapo. All right; thank you. And if the upcoming
2021 Medicare trustees report does show--and I hope it comes
out soon--that the trust fund will be depleted earlier than
2026, do you know whether you and the President will
immediately propose a detailed plan, including policy
specifications and corresponding cost estimates that extend the
life of the trust fund?
Secretary Becerra. I know the President has had many ideas
during his long tenure in service on these issues, and that at
HHS we have been working on some of these as well. We will be
more than happy to work with you and your colleagues to try to
come up with a plan.
Obviously, anything we propose will require, for the most
part, congressional approval. So, we will look forward to
working with you to make sure that we keep Medicare strong.
Senator Crapo. Well, I encourage you to do so, because I
expect we will face that situation.
Let me, in my last question here, say quickly, the
President's health-care and human services budget before us
does not include policy specifications or cost estimates
regarding a number of the health-care proposals, such as
lowering the Medicare age of eligibility to 60. Mr. Secretary,
when will we see a policy outline and scoring estimates for
these administration requests?
Secretary Becerra. And, Senator, there I think the
President has signaled very strongly. We need to continue to
try to extract as much value out of every dollar for health
care. And certainly as the chairman has said with regard to
prescription drugs, I think everyone agrees that the prices are
way too high.
And so, there are any number of ideas. Rather than outline
a specific approach, we have indicated, for example,
negotiating Medicare drug prices would save us several hundred
billions of dollars. We could do something similar to what
Senator Wyden and Senator Grassley had proposed where you push
on rebates so that, if a drug company tries to increase prices
too quickly, you get a rebate back from them. That saves tens
of billions of dollars.
The numbers are out there, whether from CBO or OMB. We are
willing to sit down and come up with a solution. We know that
you need to get the votes to pass something, but we are game
and ready to go.
Senator Crapo. All right; thank you.
The Chairman. I thank my colleague.
Senator Stabenow?
Senator Stabenow. Thank you, Mr. Chairman, and welcome, Mr.
Secretary. It is wonderful to see you. I appreciate all the
work that you are doing and that the Department is doing on
really, really important things that affect people in Michigan,
and people across the country, every single day.
It will be no surprise that I want to talk to you about
health care above the neck, as well as health care below the
neck. Because when we look at the fact that, during the
pandemic, mental health and substance abuse issues have
increased substantially--and they are going to linger long
after everything is done here. And we appreciate all the
outstanding work you have done on the pandemic, and on
vaccinations, to bring us out of this crisis.
But the good news is, as you know, that we are making
significant progress with high-quality, comprehensive mental
health and addiction treatment in the community around the
country with the expansion of Certified Community Behavioral
Health Clinics. And the fact that this is funded through the
health-care system, not just grants--I appreciate that startup
grants are in the budget, that is great, but it is not enough.
We need to fund health care above the neck the same as health
care below the neck.
So, we now have these services in 40 States, and in DC. And
they do include 24-hour psychiatric crisis services, working
with law enforcement, and programs like the chairman has
championed with CAHOOTS. So could you talk about the--because I
know in your budget, you lay out the positive impacts these
clinics are having around the country.
Secretary Becerra. Senator, I am preaching to the choir. In
fact, you are the conductor on some of these things, and so,
thank you very much for the work that you have done over the
years.
We are not going to stop, because, as you have said, we
have not fulfilled our commitment to make sure we treat mental
health with parity to other physical health conditions. And so,
you did us a great favor with the American Rescue Plan. You
provided us with some resources. About 3 weeks ago we announced
the launch of an initiative of $3 billion to help, half of it
going to mental health services, half of it going to substance
use disorder services. That would not have been possible
without your help.
We continue to work with you. This budget increases the
funding and the efforts to try to tackle this. But you are
absolutely right: we are behind on this, and we hope to catch
up as much as you will let us.
Senator Stabenow. Well, thank you. And as you know, there
are concrete results. I mean, we are seeing 60 percent fewer
people going to jail, just because there was no place else for
them to go and they needed services; 63 percent fewer people
sitting in emergency rooms waiting for help that is not there;
41 percent fewer people in homeless shelters. And so, some real
differences--concrete, measurable differences.
And I think that is why we have such strong bipartisan
support. So I would just urge you on, as Senator Blunt and I
are introducing the next step, which is really to allow States
across the country to be able to put these clinics in place.
Chairman Wyden is working closely with us. We have
Republicans and Democrats on this committee working with us,
and I hope that you will work with us to get this done. Can we
count on you to do that?
Secretary Becerra. You had me at ``hello'' on that one.
Senator Stabenow. Thank you. Let me also just ask, as I am
looking here at--I think I have gone over my time here, but I
am going to ask one other thing. That is, when we look at the
new Alzheimer's drug cost, and I have been very involved in
bipartisan efforts over the years. We have put a lot more into
research. But if people cannot afford the products ultimately
that come out of the research, we have not done our job.
And so, I was appalled that Biogen priced their Alzheimer's
drug that was approved by the FDA at $56,000 per year. I am not
going to debate whether this is effective or not, but I can
just say this is more than double the median household income
for Michiganders over 65. It is double the Social Security
yearly income, more than the average income, and I am extremely
concerned about where this is going in terms of cost to
seniors.
So, as somebody who authored the amendment to provide you
the authority to negotiate under Medicare, I hope that you will
continue to look for every possible way in order for us to
bring prices down. $56,000 a year is impossible for people.
Secretary Becerra. Senator, innovation is effective only if
patients can afford it. And so I look forward to working with
you so we have that ability.
Senator Stabenow. Thank you.
The Chairman. I thank my colleague. Senator Cassidy is
next. And, colleagues, there are a number of people who signed
up to be on the web and we cannot reach them, so we are just
going to constantly be trying to get people in order of their
appearance. And Senator Cassidy is here, and we cannot get the
folks on the web.
Senator Cassidy?
Senator Cassidy. Mr. Secretary, how are you?
Secretary Becerra. Very well.
Senator Cassidy. Mr. Secretary, it is my understanding that
HHS is still working at 25-percent capacity, limited capacity.
Now, I keep on thinking of the folks back home paying our
salaries, and they are going to wonder, if CDC has said that we
can go back to work, why isn't HHS back to work?
And I looked at the workplace safety plan for HHS, and it
says 25 percent of normal capacity during periods of
significant or high community transmission, but DC, Loudoun
County, and Prince George's are all at 1 percent of testing
positive, which is moderate at most.
How come you are still at 25-percent capacity and my folks
back home are paying for the salaries for folks who are not in
place?
Secretary Becerra. Senator, probably the best way to
respond to that is to say that in the time that we have been in
charge or in office, we have seen the number of COVID
infections dramatically drop. The number of people vaccinated
has dramatically increased. We are doing our job. That not
everybody is back, coming into the office, is not a signal that
we are not at 100-percent capacity in terms of the work
product.
We continue to produce and----
Senator Cassidy. I expect that, but still there is kind of
a general expectation that people show up to work. And granted,
some would be able to work from home, but I have also learned
that some cannot work from home. There have been people 14
months at home who could not work because their work could not
be gone over online.
So, I understand there is at least a portion of those
employees. And knowing that the CDC has given their updated
recommendations, when might we expect that new recommendation
to come in?
Secretary Becerra. Senator, I think you are seeing that we
are doing the work, as you see from this committee hearing room
that there are only a certain number of Senators here as well
during this hearing. Everyone is doing their work. We may not
be doing it as we physically saw it done a year and a half ago,
but----
Senator Cassidy. That might be, but is that to say that you
never intend to come back to full work capacity?
Secretary Becerra. Oh, of course we are going to go back to
giving people an opportunity to come back physically. But the
transition will take a little time. There are families who have
kids, who have to take care of their children. There are people
who, for whatever reason, cannot be vaccinated, who have to be
very careful.
The issue of public transportation, as you know--here in
Washington, DC especially, a lot of folks take public
transportation. So, as we transition back to a more normal way
of doing business, I think what you are going to find is that
people will appreciate the chance to come back safely. But we
are doing more than 100-
percent capacity of work in the performance that is required of
HHS.
Senator Cassidy. Although, if you are like other agencies,
there are people who have not done anything for 14 months, just
because the nature of their work could not go home with them
because it was too secure. I have learned that, with Social
Security, there is a whole group of people, the union workers,
who are not able to take their work home, and so they literally
have done nothing in terms of work.
So anyway, just to move on. Looking at your budget, the
trust fund is going--I am not talking about B or D, but the
trust fund is going bankrupt in 2040. And I see that you have
some plans to at least shore it up. But one of my concerns is
that a significant portion of the revenue is basically double-
counted. It is being used not only to strengthen the trust
fund, but also to finance the American Family Act.
These are some of the tax provisions that are changed. And
according to one projection I have read, the net effect of what
is happening will only strengthen--if we do not include
transfers from the general fund but only the new revenue coming
in from other sources--the net effect only extends the lifespan
of the trust fund to 2029. Now that is you and me, man
[laughing], you know.
So, what comments do you have on that? And are we going to
begin to count increasingly upon transfers from the general
fund in order to strengthen the Part A program?
Secretary Becerra. Senator, I think I can say this with
confidence that you and I, and pretty much every member in
Congress and in this administration, will do everything
necessary to keep Medicare strong. It has worked too well. Tens
of millions of Americans depend on it. They paid for it. I will
note, it can never go bankrupt because of the way the law is
written. It can never spend more than it gets.
And so, the concept of bankruptcy does not apply to Social
Security and Medicare.
Senator Cassidy. It doesn't, but by that same law it means
that payments to providers will decrease to the proportion that
is coming in. And if you speak to a physician and you say to
her, listen, you are only going to get paid 80 percent of what
you currently receive from Medicare, she would say, ``I will
not see a Medicare patient. I cannot afford it.'' You cannot
make up by volume when you lose on every case.
So, what are the kind of, if you will, what are the
significant plans, for example, to decrease expenditures within
the Medicare program?
Secretary Becerra. And to the point, that is why we will
not let this occur. Because I do not think any one of us wants
to expect a physician or other health-care provider to do the
services expected for far less than would be reasonable.
And the number of solutions that are out there, that have
been out there for years--I remember when I was in Congress,
many people had proposed a number that involve things like what
we did with the Affordable Care Act, which added years to the
life and solvency of the Medicare system.
It could be reducing the cost of prescription drug
medication----
Senator Cassidy. But I am speaking specifically about Part
A, not B or D. Just the hospital trust fund.
Secretary Becerra. There are still efficiencies that we can
extract in the way we reimburse hospitals when it comes to the
current system of fee-for-service, and also Medicare Advantage.
We will be working with you on any number of those solutions.
But at the end of the day, when Congress decides it wants to
come up with the big solution, we will be there working with
you to make sure we can implement it.
Senator Cassidy. Thank you. I yield back.
The Chairman. I thank my colleague.
Senator Thune is next.
Senator Thune. Thank you, Mr. Chairman.
Secretary Becerra, you and I had a conversation during your
confirmation hearing about the issue of abortion, and you
testified that you understood that there are differing views on
the issue, and expressed hope for finding common ground.
Recent polling suggests that 60 percent of Americans oppose
using tax dollars to pay for abortions, which the Hyde
Amendment prevents. And that seems to me like an area of common
ground. Yet, in your and the President's budget, you propose to
eliminate the Hyde Amendment.
And so I guess my question is, if maintaining Hyde is not
your idea of common ground, what is?
Secretary Becerra. Senator, at the end of the day we have
to try to make sure that we are providing the best health-care
services to all Americans as possible. I think the law of the
land does say that women, just like a man, are entitled to have
the health-care services that they need. And so we would try to
move forward to make sure that we provide access to good
quality care as affordably as possible. And we are going to
move forward to try and fulfill that area of the law. And we do
know there is great support for Roe v. Wade and trying to
protect the woman's right to decide how to treat her own body
and her health-care services. And so, I hope that what we will
do is achieve common ground on how we can get that done.
Senator Thune. And I would just say in response to that,
the Hyde Amendment goes back to the 1980s, and it always has
been understood, even by the President of the United States
when he was a member of the U.S. Senate, that that is an area
of--you know, having tax dollars, American tax dollars used to
support that is a bridge too far, and something that both sides
have agreed through the years, in legislation, not to cross.
And it is very, I think, disappointing for one, but two,
inconsistent with what has been long-held bipartisan policy on
that issue, to try and do away with Hyde. And so, I cannot
disagree more with you, or with the administration on their
view on that. It has consistently been--on a very controversial
issue, granted--the area where there has been broad bipartisan
agreement through the years.
On the issue of telehealth, I notice that the budget does
not contain Medicare-related legislative proposals to address
the telehealth flexibilities that have been available
throughout the pandemic. What has the Department been working
on to ensure that progress is not lost? And have you identified
any specific telehealth policies that you want to see Congress
work on?
Secretary Becerra. Great question, Senator. It is something
that is important to so many Americans. We look forward--having
taken the lessons of COVID-19 and how telehealth became so
important to so many communities--to then put that into
practice moving forward. We will need some authorities to have
flexibility to do some of these things within Medicare. And we
hope that Congress will help us move forward in ways that
really do harness the types of things that we learned from
COVID-19.
We want to make sure that broadband is accessible in all
communities. We do not want to leave anyone behind as we move
toward more telehealth. And we are learning that you can do a
lot of good health care without ever having to even see the
person that you are providing treatment to.
So there are any number of lessons that we have learned
from COVID, and we hope that Congress gives us some broader
authority and some resources to make it happen.
Senator Thune. Thank you.
As you know, many of us on this committee are interested in
how HHS and Treasury are verifying eligibility for the newly
expanded ACA subsidies. And I think we would welcome any
commentary that you can share now in response to the letter
that we sent last month.
Additionally, in light of the budget's proposal to make
these expanded subsidies permanent, what analysis has been done
by the Department to understand the effect of the proposal on
premiums and enrollment in the large and small group markets
where most Americans get their coverage?
Secretary Becerra. Senator, we will look forward to working
with you and sharing that data. What we are trying to do is
avoid, obviously, those families, mostly middle-class families,
who all of a sudden hit this cliff when it comes to coverage,
and fall off the cliff simply because they may have gotten a
small raise in their work and now, all of a sudden, that health
care that they were able to afford now becomes unaffordable,
eats up all that modest raise they may have received.
We do not want folks falling off that cliff. And so we will
share that data with you as we work towards a solution.
Senator Thune. For years we have heard about adverse
selection, the risk it poses to insurance markets for
individuals to wait to purchase health coverage until they need
it. The budget highlights the special enrollment period for the
ACA exchanges that will have been ongoing for half of 2021 by
the time it ends in August. What analysis has the Department
done on how this affects the risk pool? And can we expect to
see the administration continue to pursue such a drastically
extended enrollment period moving forward?
Secretary Becerra. We will share data on that as well. But
I am pretty sure that most of the insurers will tell you--the
fact that more than a million people have taken up the call to
sign up for health care means today we have more than 31
million Americans receiving their health care as a result of
the Affordable Care Act.
That helps insurers because, as you know, you have to
spread your risk as an insurance company. Well, the more people
who come into the system, the less risk you have that one of
those people will be very sick. And so at the end of the day, I
think this is going to be not just good for the providers and
the insurers, but certainly for the Americans who are getting
health care.
Senator Thune. My time has expired.
The Chairman. I thank my colleague. Our next three, in
order of appearance, are Senator Carper, who I believe is on
the web; Senator Toomey, who is on the web--and we need Senator
Toomey to turn his camera on; and then Senator Cardin, who is
now here. So we will begin with Senator Carper.
Senator Carper. Thanks, Mr. Chairman [faintly].
The Chairman. Senator Carper? There you are. Let's see if
we can hear you.
Senator Carper. Mr. Secretary---- [faintly].
The Chairman. Tom, it is the same problem that you had
yesterday, my friend.
Senator Carper. Okay. All right. Can you hear me now?
The Chairman. There you are. Now we can hear you.
Senator Carper. [Garbled speech.]
The Chairman. Now we cannot make anything out.
Why don't we come back to you as soon as we can, Tom?
Senator Carper. Yes, that's good.
The Chairman. Okay; we will do that.
Senator Toomey is next, and he is on the web.
Senator Toomey. Thank you, Mr. Chairman. Can you hear me
okay?
The Chairman. Perfectly.
Senator Toomey. Okay; thank you. Mr. Secretary, welcome
back.
You know, back in February of 2020 we thought the bottom
was going to fall out on State tax revenue. And so Congress
increased the FMAP for Medicaid, the Federal Matching
Percentage, by 6.2 percentage points across the board. Of
course it is worth reminding everyone that, when Congress does
that with a Federal contribution, it does not help
beneficiaries or health-care providers. It does not change
benefits or payment amounts to them. It simply results in
States paying less for the same expenditures that would have
occurred anyway, and the Federal Government pays more for
those.
Now it was, as I say, intended to deal with the risk we
perceived that State revenues were going to be extremely hard-
hit by the COVID shutdowns. But in fact it was very poorly
targeted. The biggest benefits go to States simply with the
most generous Medicaid programs, irrespective of any impact of
COVID. The main drivers of how much a State would benefit from
this would be the percentage of Medicaid enrollees in that
State, and the spending per Medicaid beneficiary. In addition
to that, and more fundamentally, of course we were wrong.
Happily, we were wrong. State governments did not have a
collapse in revenue. In fact, they had all-time record highs in
tax revenues in 2020. And that is without considering the
hundreds of billions of dollars we sent them in 2020. And then
our Democratic colleagues said, ``Let's send them another $350
billion,'' back in March I think it was, of this year, which we
did.
And you know what is happening with States. Your State of
California has got so much cash it is sitting on, it does not
know what to do with it. It is literally sending checks out to
people, irrespective of need. New York is looking to send
checks to people, including illegal immigrants--why not?--they
have so much money.
Well, the fact is that this enhanced FMAP is costing
Federal taxpayers over $3 billion per month. And it will
continue under the statute as long as the public health
emergency is declared.
So here is my question. If the administration does not end
the public health emergency in July--which is another entire
question--would you agree that at least it makes sense to end
this policy that is extremely expensive, extremely poorly
targeted, and as it turns out, given the record-high State
revenues, was never actually necessary in hindsight?
Secretary Becerra. Senator Toomey, it is great to see you.
Let me--you posed some really good questions, and I hope we
have an opportunity to discuss this further, because with FMAP
and the whole Medicaid program, it is crucial that we get these
things right. But on the first question about the public health
emergency, I think it is important to segregate that, because
I----
Senator Toomey. I do not have much time, so if we could, I
would love to avoid a discussion about the public health
emergency and whether or not it gets extended, and focus just
on this particular policy of the enhanced FMAP.
Secretary Becerra. So first I think I and many others would
thank the Congress for taking action swiftly to make sure that
States and communities did not go under. We are now seeing the
recovery from COVID.
Whether or not there is a change in the policy with regard
to FMAP, we are willing to work with you. But that is going to
be a decision that Congress makes on where we go with FMAP
moving forward. We are going to go ahead and implement the law,
as you all saw fit. And what we hope is that we can continue to
see more Americans get the coverage they need for their health.
Senator Toomey. So, I hope I can understand that to mean
that you are open to ending this extremely badly targeted,
extremely expensive, and totally unnecessary policy, because I
think that is where that should go.
One last question here--I think I am going to run out of
time. One of the exacerbating factors in this FMAP situation is
the massive estimated improper payment rate. According to
government auditors, the estimated improper payment rate in
Medicaid is 21 percent--really, completely unacceptable.
So not only are States receiving money they do not need
because they are awash in cash, but they are receiving money
with respect to payments that in many cases should never have
been made in the first place. That is how bad this is.
So here is my question. Could you commit to providing the
State-by-State estimate of the improper payment rates,
including a breakout of the eligibility component in that--
because not all improper payments are driven by ineligible
beneficiaries, but we need this information in order to reduce
an unacceptably high improper payment rate. Would you commit to
providing that data?
Secretary Becerra. Senator, I will commit to work with you
to make sure that the data that we have available that is
releasable, we will try to make available to the committee
where possible.
Senator Toomey. Would there be some kind of data you have
that it is not releasable for the Senate?
Secretary Becerra. I do not know that, and I would have to
check. I do not want to promise you something that I cannot
give you, but I will do everything I can to make sure we get
back to you and respond to that question.
The Chairman. The time of the gentleman has expired.
Senator Toomey. Thank you.
The Chairman. Two points. We are going to go back to
Senator Carper. But I would also like to remind Finance members
that we have votes on four Treasury nominees. They will be off
the floor during the upcoming votes. So please go to the
hallway outside the President's Room to vote on those nominees.
We have only a handful of Senators here now, so staff will also
spread the word.
So now I believe we have Senator Carper rejoining us, and
he believes that he is going to be able to get through. Senator
Carper, how are we doing?
[No response.]
The Chairman. That tells me how we are doing. Senator
Carper?
Senator Cardin?
Senator Cardin. Thank you, Mr. Chairman. Secretary Becerra,
it is good to see you. I want to start with prescription drugs.
I know the chairman mentioned that as the first thing off
the bat today, the high cost of prescription drugs. And Senator
Stabenow mentioned it, and I agree with that. So I want to go
from a different perspective, and that is, drug shortages.
We have high-cost prescription drugs, and then we have
drugs that are not terribly expensive that are not available
because the profit motive is not there. And as a result, we
have extremely important drugs, some used to deal with cancer
treatment, that are not as available as they should be.
I was happy to see the President's budget included $22
million for a new resilient supply chain and shortage program.
Could you just share with us how those funds, if appropriated
by Congress, would be used to deal with this drug shortage
issue?
Secretary Becerra. Senator, what we are hoping to do is
find that we have always a stockpile, that we are better
prepared, that we are telegraphing where things will go. In my
opening statement, I mentioned how we are right now in the
process of preparing for the next pandemic, the next health
crisis. And so in addressing that, one of the things we will
have to do is make sure we have the medicines necessary to
address that. So we are going to try to do what we can to try
to boost the supply, including, if possible, through domestic
manufacture of that supply.
Senator Cardin. And we have had bipartisan support on this
committee, and in the Senate, to deal with the drug shortages.
Will you commit to work with us as you develop the strategy to
make sure that America has drugs available for its population,
and we are not in drug shortage because of the supply chain
issues?
Secretary Becerra. Absolutely. And in my work as Attorney
General in California, we fought against the types of collusive
arrangements that were often made by the industry to avoid
putting more of that product on the market.
Senator Cardin. Thank you.
I was the author of the Prudent Lay Person Standard when I
was in the House with you in regard to emergency care, to make
sure that a person who has the symptoms that require them to go
to an emergency room will be reimbursed even if the final
diagnosis was not an emergency circumstance. The symptoms would
lead a prudent layperson to seek urgent care.
In 2018, I asked Secretary Azar at the time to look at
potential violations by Anthem in regards to their policies.
Well, it surfaced today that it looks like United Health Care
is also using a program that could violate the Prudent Lay
Person Standard.
And I am concerned we could see an erosion, if we do not
have the strict enforcement, so that individuals who should be
seeking urgent care are hesitant because they are concerned as
to whether their health insurance will cover that cost. Will
you be aggressive in this matter?
Secretary Becerra. Absolutely. And I am hoping that the
more we see Americans sign up for health care through the
Affordable Care Act, that fewer people will be reluctant to use
the ER.
Senator Cardin. I hope so. But we have just got to be
careful that when they say that they are not going to pay the
bill after the fact, and then maybe they could win in appeals,
et cetera, unless there is clear direction to use urgent care
when it is needed, we are liable to lose some people who are
hesitant to go to emergency care. I just urge you to be
aggressive in this and not let the insurance carriers carry the
day. We were very clear on the Prudent Lay Person Standard.
Secretary Becerra. I look forward to working with you on
this.
Senator Cardin. Then on minority health and health
disparities, President Biden has been very clear about his
commitment to deal with historic challenges we have had.
Included in the Affordable Care Act was the National Institute
for Minority Health and Health Disparities that I authored. I
was pleased to see that the President's budget includes an
increase of $261 million for the National Institute for
Minority Health and Health Disparities. Could you tell me more
about the importance of expanding HHS's investment and research
to address longstanding inequities?
Secretary Becerra. Senator, first, thanks for all the work
that you have done on this. And as you have mentioned, we are
going to put real money behind this effort. What that will
produce, I think, are not just lives saved but better outcomes
for kids in the future. The fact that, for example, in America
we still have pockets where women often die delivering a child,
that our maternal mortality rates are out the roof, higher than
any other industrialized nation--we are putting money behind
efforts to try to address that.
We are going to do everything we can to put equity at the
front of everything we do and think about when it comes to
health care. But we look forward to working with you, because
there is some real money--and thank you, by the way, for the
help during the American Recovery Plan to make sure that we
have resources to get behind that.
Senator Cardin. Well, thank you. I will just conclude by
acknowledging that your budget includes an expansion of
Medicare for dental, hearing, and vision. I have been pushing
for particularly the dental aspect to that. There is bipartisan
support here again, and we look forward to working with you in
that regard.
Secretary Becerra. Thank you.
The Chairman. Thank you, Senator Cardin. Our next two
questioners will be Senator Grassley, and then Senator
Menendez.
Senator Grassley?
Senator Grassley. I know that you have a big interest, and
President Biden has a big interest, in reducing drug prices.
There are a lot of Republicans in the United States Senate who
want to do it. And I would conclude that if President Biden and
his staff feel it can be done by reconciliation, then I think
that I would quit talking and not ask any questions.
But if they would come to the conclusion that possibly some
of the things that are being talked about on the Democratic
side cannot get 60 votes in the U.S. Senate, I think it would
lead you to the work that Senator Wyden and I have done over
the last 2 years on reducing the price of drugs, and probably
could easily get 65 to 70 votes in the U.S. Senate, and maybe
even more than that. We did have 10 House Democrats who wrote
to Speaker Pelosi worried about getting something done on
prescription drugs, if it was not a bipartisan prescription
drug bill.
So that kind of brings me to this dialogue with you. Can I
infer from the fact that the President's budget does not assume
passage of H.R. 3, that the administration accepts that there
is no path forward on H.R. 3? Would you be willing--if that is
something you might agree to, would you recommend to President
Biden that he instead focus efforts towards supporting a
bipartisan bill that can get 60 votes in the United States
Senate and then get something done big time in this area,
because big pharma does not like what Grassley and Wyden have
been working on for 2 years?
Secretary Becerra. Senator, first, thank you for all the
work that you have done with the chairman to try to get this
done. I think we are anxious to work with the two of you, and
members on both sides of the aisle and in both chambers, to try
to get something done.
The President has said plainly that he wants to get behind
some reforms to reduce drug prices. He has said he is open to
and supports negotiating prices. He has said he supports the
idea of seeking rebates when prices are too high. And I think
what the President has signaled in his budget is that we are
open to make sure that what we end up doing is reducing the
price of prescription drugs for Americans. And so, we look
forward to working with you and all of your colleagues to get
something done.
Senator Grassley. On another item, I worked with Senator
Warren for over 4 years to provide access to over-the-counter
hearing aids. Since the 2017 law passed, the FDA has not issued
regulations to establish an over-the-counter hearing aid
market. By the way, I hope Senator Warren did not bring this
up. If she did, I do not want to----
The Chairman. Senator Warren has not brought it up, but I
have known that you and she have this important bill, so go
ahead.
Senator Grassley. Okay. Well, I did not want to take time
if she had done that. Anyway, since the 2017 law passed, the
FDA has not issued regulations to establish an over-the-counter
hearing aid market.
Recently, the FDA authorized Bose to sell its over-the-
counter hearing aid products, but there is no market for Bose
to sell its product. So my question to you is, can you provide
a timeline on FDA issuing over-the-counter hearing aid
regulations? If not, what is the current status of a draft
regulation? And what barriers are there to preventing FDA from
issuing regulations in that area?
Secretary Becerra. Senator, I know that we are in the
works. I asked about this myself. I asked because my mother
asked me when we were going to deal with this, because she is
one of those victims of those hearing aid commercials, and so
forth, and she is fed up with what happened with her. And she
is out some money. But I will tell you this: we are trying to
work diligently to put this regulation out there.
We know millions of Americans will benefit if we can help
them make sure they are good consumers of hearing aids.
Senator Grassley. This is something--this will have to be
my last question. I have written two letters, March 8th and May
26th, to the Department asking what, if any, oversight was done
on the virus grants that Dr. Fauci's unit sent to EchoHealth
Alliance. I am going to skip some of that intro on that
question.
Did the Department--so here is the question--did the
Department of Health and Human Services specifically identify
Dr. Fauci's unit? Did you do any oversight of the taxpayers'
money sent to the Wuhan Institute of Virology? If so, can you
say with certainty that the money was not misused by the
Chinese Government? And if no oversight was done, please
explain, if that is the case.
Secretary Becerra. Senator, thank you. And as you know, the
principals at the NIH, and obviously Dr. Fauci among them, have
made it very clear: the NIH never approved of funding for the
Wuhan Institute of Virology. And what we are doing is
continuing the accountability work that is out there that the
President has called for. I made a call for that about a month
and a half ago. And I think you all are now making a call for
that in this recent legislation that came out of the Senate to
make sure we get to the bottom of this.
And so, at the end of the day, I think we are going to get
to the bottom of how things happened with regard to this
coronavirus. But I can guarantee you that the NIH never
approved any money to go directly to the Wuhan clinic.
The Chairman. The time of my colleague has expired.
Senator Menendez?
Senator Menendez. Mr. Secretary, good to see you. I did not
intend to talk about this, but I just want to make a point that
when we talk about prescription drug reform, there are many
ways to try to seek it. What I am concerned about is, I
consistently see that we take revenue from the pharmaceutical
industry, but we do not lower the cost of prescription drugs.
So I do not quite get it, that if you keep taking revenue from
the industry but you do not lower the cost of prescription
drugs, how does that help the consumer?
So for me, the bottom line is going to be: show me how you
are going to lower the cost for consumers on prescription
drugs, and do so in such a way that--and we just saw in the
midst of this pandemic how important this industry is to
produce a life-saving vaccine. So I think we have to get our
priorities right in that regard, and that is going to be my
bottom line.
Let me ask you something. While official 2020 data on all
gun deaths is not yet available, every analysis of data from
the Gun Violence Archive shows that gun-related deaths in 2020
will likely exceed 40,000, a rate of 12.3 gun deaths per
100,000 people. This translates to the highest rate of gun
deaths in the last 2 decades.
So my question to you: do you believe that gun violence is
a public health epidemic?
Secretary Becerra. Senator, of course. And I agree with the
American Public Health Association that believes it is a public
health issue as well.
Senator Menendez. As such, will you commit to ensuring that
the CDC funding is used to study gun violence as a public
health epidemic?
Secretary Becerra. Not only will we commit to that, but we
are asking for funding to make sure we can do this well.
Senator Menendez. All right. I look forward to supporting
that.
Now, as you and I had discussed before in this committee,
our country is facing a projected shortage of up to 124,000
physicians by 2034. Increased Federal investment in physician
training is a key piece of helping to address the physician
shortage. And prior to the end of last year, Medicare support
for GME had been effectively frozen for nearly 25 years, a
quarter of a century.
My bipartisan legislation, the Resident Physician Shortage
Reduction Act, will build upon the 1,000 Medicare-supported GME
slots that I secured last year by providing another 14,000
targeted slots over 7 years.
So, looking at the needs of our population, how will the
1,000 slots that Congress provided last year, in addition to
future additional training slots, address the physician
shortage? And how will you ensure their expeditious
implementation?
Secretary Becerra. First, Senator, thank you for that work.
I think those of us who have--when I represented that community
in the past as a member of Congress, we too fought to preserve
those residency slots in areas of need. And so what we are
going to do is, we are going to go out and talk to the provider
community to make sure that we know exactly where there are
shortages.
We are going to try to encourage a lot of incoming
physicians to consider working in those areas of shortage in
rural areas, in low-income communities, and we are going to try
to make sure that the residency slots will be there to meet
them when they are ready to come work in those areas that need
new physicians.
Senator Menendez. All right. Well, we look forward to
working with you on that.
We are finishing twin pandemics of pervasive racism and
COVID-19, which have laid bare health inequities facing many
minority communities. According to the CDC, women of certain of
these communities are two or three times more likely to die
from pregnancy-related causes than white women. The budget
proposes some significant investments in addressing the
maternal mortality, which is great, but how specifically do you
plan to combat the crisis, including reaching and working with
these at-risk communities? And what workforce investments have
to be made to improve maternal mortality?
Secretary Becerra. Well first, you all helped us
tremendously with the American Rescue Plan, and you made some
funds available for us to target some of this. We are focusing
a lot on maternal health, because it is embarrassing to say
that the richest country in the world has some of the worst
outcomes when it comes to maternal mortality.
We have an investment in a program called the Improving
Maternal Health Initiative which would help us go into these
communities where we see mostly women of color being the ones
who experience the terrible outcomes, in some cases including
death. And if we are able to, with your help, secure passage of
the American Families Plan, we will have an additional
investment of some $3 billion to really target communities that
have been left behind.
Senator Menendez. All right.
And finally, the President's budget supports eliminating
the current Medicaid funding structure for territories, and
proposes treating our citizens, U.S. citizens who live in the
territories, the same as citizens living in States. Will you
commit to working with me and the committee--I am thinking
about Puerto Rico, but it is not the only one--on a path
forward for parity?
Secretary Becerra. Senator, I absolutely look forward to
working with you. The President has made it very clear, every
American citizen should have access to quality health care,
regardless of where you live, what your ZIP code might be.
Senator Menendez. Thank you.
The Chairman. I thank my colleague.
I think we are going to see if Senator--let's see. Senator
Cantwell is here in person. Senator Cantwell, would you like to
go next, because you are here early?
Senator Cantwell. Thank you. Mr. Secretary, good to be with
you.
Obviously, one of the concerns we have moving forward on
health care, as we have expanded access to care which we saw
was so important during COVID--but pre-COVID we still had
issues of affordability. What are your ideas for how we put
more affordability into the system?
Secretary Becerra. Well, we continue to improve the
Affordable Care Act versus trying to dismantle it. That would
be one of the best things. We have seen how Americans, when
given a choice, when they see what their options really are,
will sign up. We have had over a million people sign up to get
new coverage under the Affordable Care Act in the last few
months as a result of the President's special enrollment
period.
We are now at 31 million Americans who have taken advantage
of the Affordable Care Act and today have coverage as a result.
And so, if we can continue to expand coverage, what we will
find is that we will be able to provide it at a more affordable
rate, instead of watching people walk into an emergency room to
get their primary care services.
And so there are any number of ways we can continue to
extract greater cost efficiencies as we continue to expand
care, and we are looking forward to working with you on some of
the ideas that I know are percolating in Congress to make that
happen.
Senator Cantwell. So, you know I am a big fan of the basic
plan, which New York implemented, so a $500 annual coverage for
a family of four, versus what you would have in the Silver
Plan, so $1,000 in savings. So I am a big fan at least at that
income level, expanding the market because, you know, I keep
trying to explain it as the Costco model, because you are
buying in bulk and they are giving you a discount, both on
prescriptions and for health care. So we are a pretty big fan
of that.
I also wanted to bring up--we feel that we need to continue
to drive down costs as we have expanded our access to
telemedicine. So not only do we need to do our side on the
broadband expansion to make sure that the telehealth can be
delivered, but we also need to get the right reimbursement
rates.
How do you suggest we should look at that so that we can
get the actual system to expand more into telemedicine?
Secretary Becerra. So COVID-19 taught us a great deal on
telemedicine. And what we are finding is that the more
flexibility we offer, the greater the chance that something
like telemedicine will be used, and used well.
We need to have some basics in place. We have to make sure
that broadband is available in all communities. We do not want
to leave people behind simply because broadband has not caught
up to them. But we know that once you have access to good
technology, then it is a matter of making sure we can implement
in ways that make sense.
In some cases it will be virtual, with video. In some
cases, it might be just audio. We want to be flexible, but we
want to extract accountability. We want to make sure that if we
are going to extend something like telehealth and telemedicine,
we are ensuring that, at the end of the day, we are getting
real value for the dollars we are providing for that service.
So accountability will be crucial.
Senator Cantwell. I think there is real value here, and I
am happy to work with you and others at the University of
Washington, which has been a leader in this. And we think there
are efficiencies and savings.
Another area of efficiencies and savings is in the area of
home health, the money follows the person concept. My
colleague, Senator Portman, and I have worked on this. This is
to basically allow older adults and people with disabilities to
leave the institutional setting and receive community-based
care. Your budget has a $400-billion investment in community-
based services. So we appreciate that. But we think we have to
continue to move forward on having established community-based
health-care services for individuals, and delivering that care
at home.
Secretary Becerra. You had me at ``hello'' on that. My
father died in my home. We cared for him in his last months,
and he lived with me. My mom and he lived with me for the past
4 years, and we were able to provide him the best care he could
get because he was with family, and he died with his family
surrounding him.
I think everyone would like to know that they can receive
care, including hospice care if possible, at home. But one way
or the other, we have to make sure it is good care, community
care; family care, obviously, is among those.
Senator Cantwell. Well, I am sorry to hear about your loss
of your father, so my thoughts are with you. It is a tough
challenge for all of us as our parents age.
One last thing that I wanted to bring up is, yesterday we
had a hearing on NCAA sports issues and NIL rights. One of the
things that we want to make sure of is that health-care
standards are there for athletes. Some of the testimony
revolved around the number of deaths in college athletics as it
relates to heat exposure, and the practices juxtaposed to
professional football that did not have those same numbers. So
clearly people have made decisions about the environment, and
so we want to work with you on what we think are health
standards for our collegiate athletes. And if you could find us
the right person, we would appreciate it.
Secretary Becerra. I look forward to working with you.
The Chairman. The time of my colleague has expired. We are
still going in the order of appearance, so I believe the next
would be Senator Brown and then followed by Senator Casey, who
has been very patient.
Senator Brown, are you there?
Senator Brown. Yes, I am. Thank you, Mr. Chairman, for
holding this hearing. Secretary Becerra, it is good to see you
again. And thank you for appearing here fairly regularly.
Thanks for the work you have done to implement the Rescue Plan.
Thanks for coming to Columbus recently to see some of the
great work that we are doing in Ohio. We expect you, and hope
to invite you back to other places around Ohio.
I want to thank you for including such robust funding for
CDC in this year's budget request. As you know, the U.S. has
underfunded public health for decades. The President's budget
proposal to increase funding to $8.7 billion, the largest
budget authority increase in the CDC in 2 decades, is long
overdue.
If you would, just sort of paint the picture for us, Mr.
Secretary, why this funding is so important to help prepare for
future global pandemics. We essentially surrendered before by
underfunding public health. What does this mean for us?
Secretary Becerra. Senator, as you know very well, when
COVID hit, even though we have the most sophisticated health-
care system in the world, we found that there were clearly
pockets in America where that health care was not reaching. And
the result was devastating. We have had more people die in
America--we are 6 percent of the world population, but no
country, including India, has suffered greater numbers of
deaths.
And so, we know that we have to change that. And public
health is that safety net. It is that fabric that protects us
from falling through the cracks. And we know we must invest
more in making sure that we are ready to deal with what is a
community issue. It is not just that you caught the flu and now
you just take care of yourself. No, every one of us is at risk
if you catch the COVID-19 virus.
So, it is important for us build the infrastructure that
public health is to make sure that we are protecting all of our
families.
Senator Brown. Well, thank you. The President's budget--let
me shift to another issue. So, I was in Toledo over the
Memorial Day week, and Lucas County Children's Services has
been working to address issues about child welfare. The
President's budget includes a new request for $100 million to
address racial disparities in the child welfare system. Child
protection interventions, as you know, disproportionately
impact black and American Indian and brown children and
families.
As I talked to some people from the Lucas County Children's
Services in Toledo, they talked to me about wanting to know the
goals for this funding. What you are planning to do? And I
would like you to commit to my office, and to these parents,
that you will talk to us and work with us in the future funding
opportunities in this space. So talk about the $100 million and
where you expect to go with it.
Secretary Becerra. Senator, the most important thing I can
tell you is that we are not going to come up with the
solutions, or the ways to drive the money. We are going to work
with you and those local communities so that you put before us
the best uses of the dollars.
We know that these inequities are out there. And we know
that folks back home understand what it takes to address them.
And so we want to work with the folks that you know who are the
professionals who know how to do this, so when we use those
monies, it is targeted and it is effective.
Senator Brown. Thanks. And I want to raise--I probably will
not use my whole 5 minutes--I want to raise one other issue.
Mr. Secretary, you and I worked on this in the House together.
We came up together--with you in Ways and Means and me in
Energy and Commerce--with funding for children's hospital
graduate medical education. The peculiarity of the way we fund
that education left out children's hospitals, because the
dollars came from expenditures on seniors, essentially, or on
middle-aged people, not on children.
Your budget has--I am concerned your budget has eliminated
the CHGME program and lumped its finding in with that of other
graduate medical education programs. We had started this in the
mid-90s. It has worked. Every President has tried to underfund
it. We have restored it.
But I would like for you, if you would, to say something
positive to this committee about the importance of children's
hospital graduate medical education and the training that we
have done well in this country for the last 25 years.
Secretary Becerra. Senator, I think, as you remember, for
24 years when I served in the House, Los Angeles Children's
Hospital was based in my district. And I saw some of the
miracles that were performed there by the people at the
children's hospital.
We are not going to--I commit to you this--we are not going
to let those who care for our kids suffer because of the way
that we sometimes distribute the slots for medical education.
We have to continue--and we know this, that we need to provide
more physicians in areas of primary care, children's care, and
some of the specialty cares. So I commit to you that, at least
under my watch, we are going to do everything at HHS that we
have to do to ensure that we provide for the funding of
graduate medical education to make sure we have the physicians
we need.
The Chairman. I thank my colleague. And again, we are going
by order of appearance, so we can get three more in at least
before the vote: Lankford, Bennet, and Casey. I might want to
tell my colleague from Pennsylvania, I know he has been very
patient, but that is the order of appearance.
Senator Lankford. Thank you, Mr. Chairman.
Mr. Becerra, it is good to see you, and good to be able to
check in with you again. I sent a request to your office that I
have not received a reply on, so I just want to be able to
remind your team of a request. It deals with the unaccompanied
children coming across the border, and some of the data that we
have requested. We know this is data that is collected. I have
been down to visit, in three different areas, some of the HHS
facilities along the border in the last 3 months. I know all
this data is collected, but we are not able to get access to
it.
For instance, the number and percent of category 1, 2, and
3 sponsors for the UACs; the ages of the UACs. There is a
record that is kept of how many have been sexually assaulted on
their journey, and how we are providing medical care for those.
None of those things we have been able to get access to that we
have made numerous requests for. Can you help us actually get
that done? We are not asking for extraneous information that is
not already collected. We are asking for the information you
already have.
Secretary Becerra. Senator, let me get back to my team and
find out where that request is on your letter that you sent us.
Senator Lankford. That would be very helpful; thank you.
At your nomination hearing, you and I talked about
conscience and freedom, and freedom of faith, all those
protections that are there. I was surprised to see the language
in the budget had stripped out much of that language that had
existed in previous budgets about freedom of conscience,
freedom of religion. And it also seems that you are eliminating
the Conscience and Religious Freedom Division. Is that true? In
your budget, are you eliminating the Conscience and Religious
Freedom Division?
Secretary Becerra. We are going to continue to do the work
to protect the religious, civil, constitutional rights of all
Americans under HHS's purview. And we are going to continue to
be a solid organization, through the Office of Civil Rights
that we have, to make sure that we are protecting everyone's
rights, including religious conscience rights.
Senator Lankford. But you are taking away that division as
a priority and putting it under something else? Or where is it
going?
Secretary Becerra. It continues to function. The work
continues to be functioning under the Office of Civil Rights.
Senator Lankford. Okay, so it has not changed? Or it has
changed?
Secretary Becerra. The work will not change. I mean, we
continue to have a responsibility to protect the religious
freedom of all Americans when it comes to any of the health-
care programs that are out there. We will continue to provide
protections for the civil and constitutional rights of all
Americans, including those that involve religion. And so
nothing there changes.
Senator Lankford. Okay. We will follow up on that in the
days ahead to be able to see how that office moves, and how
that shifts. I also noticed you changed a term in your budget
work. You shifted from, in places, using the term ``mother'' to
``birthing people'' rather than ``mother.'' Can you help me get
a good definition of ``birthing people''?
Secretary Becerra. Well, I will check on the language
there, but I think if we are talking about those who give
birth, I think we are talking about--I do not know how else to
explain it to you other than----
Senator Lankford. I was a little taken aback when I just
read it and saw it, that the term ``mother'' was gone in spots
and it was replaced with ``birthing people.'' And I did not
know if this was a direction that you were going, if there were
shifts or regulatory changes that are happening related to
that, or what the purpose of that is.
Secretary Becerra. I think it is probably--and again I
would have to go back and take a look at the language that was
used in the budget, but I think it simply reflects the work
that is being done.
Senator Lankford. I definitely get that. I would only say
the language is important always. We do not want to offend in
our language. I get that. But would you at least admit calling
a ``mom'' a ``birthing person'' could be offensive to some
moms, that they do not want to get like a ``happy birthing
person'' card in May? I mean, can you at least admit that that
term itself could be offensive to some moms?
Secretary Becerra. Senator, I will go back and take a look
at the terminology that was used, and I can get back to you.
But again, if we are trying to be precise in the language----
Senator Lankford. ``Mom'' is a pretty good word. That has
worked for a while, and I think that it is pretty precise as
well.
In 2015, NIH paused funding for the human/animal hybrids
chimeras--and you are familiar with the term--and had done
research back before that, and you are aware that China is now
advancing in chimera work.
In 2015, NIH paused and said, ``We are not going to do
that.'' Is NIH going to continue that moratorium or are you
going to lift the moratorium and attempt to use tax dollars,
Federal tax dollars, for chimera research here or to fund
chimera research in other countries?
Secretary Becerra. So I know that NIH has taken a close
look at where it is placing its money, the type of research
that is being used. I think you will understand and respect the
fact that we give NIH a great deal of latitude because they
take action based on the science, not on the politics. And so
you will understand when I say to you that what NIH will do
tomorrow is not because the Secretary of Health and Human
Services has told them to go in a particular direction, it is
because the science takes them there.
And we can make sure we give you a better response more
directly by NIH on where they plan to go. But I would not want
to infer to you that I could--that I will dictate to NIH what
they will or will not do.
Senator Lankford. Please. We would be glad to get that
information back, because this is not just science; this is an
ethics and moral issue as well.
The Chairman. Colleague, thank you. With the thoughtfulness
of Senator Daines, we will go with Senator Bennet, Senator
Casey, and then Senator Daines. We are going to do all that
before the vote.
Senator Bennet, on the web.
Senator Bennet. Thank you, Mr. Chairman. And, Secretary
Becerra, it is great to see you. Can you hear me?
Secretary Becerra. I can.
Senator Bennet. Great. Then I hope you and your family are
well, and that you are settling into your new role. The last
time you were here we spoke about the importance of a public
option that would finish the work of the Affordable Care Act.
And I am thrilled that the budget makes the changes we made in
the American Rescue Plan to the premium tax credit--made those
changes permanent. And as you know, this is an important
provision in the Medicare Choice Act, my bill with Senator
Kaine, to create a public option.
In Colorado, we have seen premium decreases as a result,
anywhere from 17 percent, even much more than that, depending
on where people live. For example, a family of four in Summit
County, CO are going to see average savings of $151 a month,
which is a tremendous accomplishment. And that is why we should
make these credits permanent, to allow for continued savings
for America's working families.
I am really concerned that, without establishing a public
option alongside these credits, there will be many Americans
who will not have a quality plan offered in the area that they
live. Many of those are rural areas, but not only. In Colorado,
there are 10 counties where there are no plans, or only one
plan in the individual market. This obviously reduces quality
and competition and increases costs.
Could you discuss your views on a public option, and
provide a timeline on when we can begin working in earnest
together on refining our proposal?
Secretary Becerra. Senator, thank you for the question.
Actually, my views on the public option are fairly well known.
When I was a member of the House, I was active in those issues
on the public option, and in my votes.
Certainly President Biden, who is perhaps the more
important person to concentrate on here, has said he is very
supportive of a public option as a way to help reduce the cost
of coverage for all Americans. And the President has said he is
very open to working with the House and Senate to try to come
up with a solution which could include the public option. And
we look forward to working with you and other members who have
been trying to formulate a good plan that could get votes.
I will simply tell you that, on the cost side, the public
option has been shown--whether it is through the Congressional
Budget Office or the Office of Management and Budget, the score
keepers for the Congress and for the executive--to produce
savings. And as you mentioned, what we want to do is provide
greater access. The public option is one of those opportunities
that gives Americans a great chance to get coverage at a lower
cost.
Senator Bennet. I hope we will work on it. As you know, the
President ran on this. And you are right, you are absolutely
right: it saves the Federal Government money while creating
universal health care through a choice that every American can
have.
I mean, I think this would be an extremely successful
initiative, and a popular one with the American people,
especially after the pandemic. So anything we can do to help
with that, I would hope you would let me know.
Let me, in the last couple of minutes I have, turn to
another part of your budget. The budget includes $400 billion
in funding for home and community-based care through the
American Jobs Plan, which will transform the way that we care
for individuals in their homes and communities. This funding,
through Medicaid, will take care of the most vulnerable
Americans, especially children and youth, and this type of care
was absolutely critical in Colorado over the course of the
pandemic.
I am concerned with the increased rates of mental health
illness that young people are experiencing, leading to death by
suicide, substance abuse, or other mental and behavioral health
challenges.
How should we use this funding to help address these mental
health challenges? And how can mental health be integrated in
home and community-based services for children receiving these
services?
Secretary Becerra. Senator, I know that there are a lot of
folks back home in Colorado, and in my State of California, and
throughout the country, who would chime in and tell us what has
worked, the best practices. But what I will tell you is this.
The closer we get to someone's home, their family, in providing
that service, the more likely we will see success. The more you
farm out people to these institutional settings, I think less
caring, it seems, and less loving care would be provided.
So I think the home and community-based setting is crucial.
And to the degree that we have innovative programs that are out
there that we can help support, I think that is what we will
try to do at SAMHSA. Working with folks that you know back in
your home State, I think we will try to do the best we can, not
just in Colorado but throughout the country. But really it is
pretty straightforward. It is not rocket science to try to
provide the treatment that people need as quickly as you can,
hopefully to prevent things from getting worse, and to try to
do it with someone who is as dear to that person as possible,
to make it a loving setting. And then to try to make sure that
you are implementing some of the innovation that is out there,
providing resources to those who have shown a different way
that is working well for others.
The Chairman. The time of the gentleman has expired.
The very patient Bob Casey, and then Senator Daines, also
patient.
Senator Casey. Mr. Chairman, if I cut my time in half, can
Senator Warren go after?
The Chairman. We are going to do our best, because you all
have been such good sports.
Senator Casey. I will try to keep the first question brief.
Mr. Secretary, it is great to be with you. You have been asked
a couple of times about home and community-based services,
which are a huge priority for me, but more importantly for the
people who will benefit from them: seniors, people with
disabilities, and of course the workforce who does heroic work.
You have your own personal experience with your dad, so I
know you understand the necessity of it. I am not going to ask
you a question. I just want to commend the President and the
administration, and you and others, for making it such a
priority. I would just highlight one individual in my home
State in Lancaster County, Katelyn Montanez, who has provided
care for her father Louis, who has had younger-onset
Alzheimer's. She is one of those great examples of a family
caregiver out there who is doing that important work.
For so many families, home and community-based service,
just like child care, is their bridge to work. They may need a
bridge, a physical bridge to work, but the bridge to work for
so many families is home and community-based services. So we
have to get that done as part of the caregiving infrastructure.
I wanted to ask you about junk plans. I know that the
administration has included on the order of $163 billion in the
budget to help Americans access affordable health care. These
dollars will permanently extend changes that were implemented
in the American Rescue Plan to provide access to health
insurance for about 3.6 million more Americans.
I applaud these changes and improvements to the ACA. But I
am also concerned that Americans understand the options that
are available to them. In 2019, my office conducted an
oversight report on online ads for health insurance, finding
that consumers who search for insurance online are at risk of
being funneled into a non-ACA-compliant junk plan by misleading
ads that appear in some search results.
I know the administration is committed to defending access
to quality affordable care, particularly your efforts to
reinvest in ACA enrollment and outreach efforts. I would like
to see what more steps we can take to protect consumers.
Mr. Secretary, could you talk about ways in which the
fiscal year 2022 budget request will support efforts to protect
consumers from misleading ads?
Secretary Becerra. Senator, thanks for the question and
your work on this issue. Perhaps the most important thing we
can do is prevent consumers from ever applying for or paying
for any of these junk insurance plans. And that is why we are
putting in an investment of some $80 million into the Navigator
program, which helps people understand the plans that are out
there, what plans actually service their needs. And so that
way, when they make a decision to start enrolling and paying
for a plan, they are making the right decision from the
beginning.
We are also going to expand the funding for the outreach
and the education that it takes to make sure that people
understand health insurance and what they need, if they are a
family of four, or they are a single individual, they are 20
years old, 30 years old, or they are 80 years old. Those are
the kinds of things that you want to know about a person so you
can direct them.
But aside from that, we are also going to do more
accountability as well, to find out who those industry players
are that are trying to take advantage of the American consumer
the wrong way.
Senator Casey. Mr. Secretary, thank you. I will say to the
chairman, I am going to yield back some time here. I just want
to--I will send you a statement about a nursing home bill that
Senator Toomey and I have, a bipartisan bill, on nursing homes.
But I will yield back the last minute. Thank you, Mr.
Secretary.
Secretary Becerra. Thank you.
Senator Crapo [presiding]. Next, I am told, we have Senator
Carper, who was online, and we had trouble earlier. Are you
back, Senator Carper?
Senator Carper. Yes, I am back. Can you hear me?
Senator Crapo. Yes.
Senator Carper. Great. Thanks so much. Welcome, Mr.
Secretary.
In 2019, then-Ranking Member Ron Wyden and then-Chairman
Chuck Grassley led this committee in passing bipartisan
legislation, as you know, to reduce prescription drug prices
for Medicare beneficiaries. The legislation also would have
lowered drug prices for seniors, lowered drug prices for
Medicare and Medicaid, and required the drug companies to make
price increases publicly available. I spoke with you recently
about your willingness to explore whether that Finance
Committee bipartisan bill might be pulled off the shelf, dusted
off, and maybe used as a base on which to build for future
legislative efforts in this space.
I do not know if you have had a chance to think about this
at all, but I would welcome your thoughts, if you have them.
Secretary Becerra. First, I appreciated that conversation
we had, and I enjoyed your thoughts. And what I would say to
you is, we would like to see these projects launch, and we know
that----
Senator Carper. Mr. Secretary? Mr. Secretary, can you hear
me? Hello?
Secretary Becerra. Senator, we can hear you. Can you hear
me?
Senator Carper. I don't hear anyone speaking. I hear
Sheldon laughing.
Senator Whitehouse. Yes, I hear you. I do not know----
Senator Crapo. We all hear you, Senator Carper.
Senator Carper. Mr. Secretary? Earth calling Mr. Secretary?
Secretary Becerra. I'm here, Senator.
Senator Crapo. Senator Carper, can you hear me? This is
Senator Crapo.
Senator Carper. Is anybody out there?
Senator Crapo. Senator Carper?
Senator Carper. All right, Mr. Chairman, I am not sure what
we do in this case, but this is the third time I have tried to
ask this question. I am 0 for 3.
Senator Crapo. Well, we have the Secretary here, and he is
responding, but apparently, you can't hear him. Is that
correct?
Senator Whitehouse. It seems like the committee feed is
down. I just see the clock.
Senator Crapo. Senator Carper, I apologize, but I guess we
are going to have to move on again. I apologize for this.
We are going to go to Senator Daines.
Senator Daines. Thank you, Senator Crapo. Mr. Secretary,
thanks for being here today to discuss the President's proposed
HHS budget.
The proposed budget is concerning in several ways, Mr.
Secretary, but I'd like to start with the omission of the Hyde
Amendment, the protections that we have had bipartisan
agreement on for decades. Abortion, as you know, is a violent
procedure that destroys the life of innocent, pre-born
children. Because of this brutal fact, every year since 1976,
Democrats and Republicans in Congress have banned taxpayer
funding for abortion through the Hyde amendment. Even though it
saved more than 2.45 million lives, which by the way is enough
to fill 36 NFL stadiums, your budget calls for completely
eliminating the Hyde Amendment and its protections.
Mr. Secretary, under your proposed budget, do you know how
many taxpayer-funded abortions would be performed on children
who can feel pain?
Secretary Becerra. Senator, let me see if I can try to
respond, because I know that this is a question that has arisen
many times. We have deeply held beliefs in this regard, and
sometimes we differ--and I respect that.
My job is to make sure that I follow the law. And when it
comes to a woman's reproductive rights, we will make sure that
we follow the law.
Senator Daines. Regarding the law, yesterday in the House
hearing, you were asked a question about, is partial-birth
abortion illegal? What is your--that's a question: is it
illegal?
Secretary Becerra. What I can tell you is that women in
this country under Roe v. Wade have a right----
Senator Daines. Is partial birth abortion legal or illegal
in the United States?
Secretary Becerra. Senator, again, we are going to get into
this technical discussion----
Senator Daines. It is not a technical discussion, it is a
question that's pretty simple. Is it legal or illegal?
Secretary Becerra. A woman has a right to receive an
abortion here----
Senator Daines. So are you saying it is legal, a partial-
birth abortion?
Secretary Becerra. What I can tell you without question is
that a woman has a right to exercise her----
Senator Daines. As Secretary of HHS, I would hope you would
understand that title XVIII of the U.S. code, section 1531,
signed into law in 2003, States that partial-birth abortion is
illegal. Do you agree with that?
Secretary Becerra. Senator, I could talk to you about the
legal cases that have arisen as a result of that particular
statute, but what it is probably better, again, to say to you
is that a woman has a right in this country to exercise
reproductive choice, and we will defend that in every respect--
--
Senator Daines. That does not mean breaking the law on
which the code is very clear on partial-birth abortion.
Secretary Becerra. We will never break the law. On my
watch, we will never break the law.
Senator Daines. Okay, so the question is, is partial birth
abortion legal or illegal? It is not a trick question or a
complicated question.
Secretary Becerra. Senator, I will direct you, then, to the
decisions that the courts have issued with regard to that
particular statute, if you like. And that is why I continue to
repeat to you that what is the law is the right of a woman
under Roe v. Wade to receive reproductive health-care services.
Senator Daines. How many late-term abortions would you fund
involving children who can live outside the womb, based on your
budget?
Secretary Becerra. Senator, we are going to make sure that
we follow the law and provide women access to the health-care
services that they need.
Senator Daines. Let the record reflect that the budget you
have presented to Congress will force taxpayers to send a blank
check to the abortion industry to pay for abortions without
limit, and you do not even know how many, or what it would
cost, and are not even sure if partial-birth abortions are
legal, even though the code is clear, or how many might be
late-term abortions on children who can feel pain and can
survive outside the womb.
Frankly, this is abortion extremism. I would ask that you
please follow up on the record with these figures with the
budget you have proposed.
I want to shift gears and talk about the border crisis.
This year alone more than 700,000 migrants, including more than
60,000 unaccompanied minors, have illegally entered the
country, the vast majority of them since February. This week,
Vice President Harris was in Guatemala and Mexico, meeting with
leaders to discuss the root causes of migration. She was
appointed by the President 78 days ago to lead the
administration's response to the border crisis, yet she still
has not taken a trip to the southern border.
Mr. Secretary, if the Vice President and this
administration are serious about finding the root causes of
migration, shouldn't you be looking at your own policies which
have clearly driven this problem to an unsustainable level?
Secretary Becerra. Senator, again, the law requires that we
address the issues at the border. At HHS, again, we have
responsibility for the care of those unaccompanied migrant
children. I will not speak to the issues that are under the
jurisdiction of the Department of Homeland Security, but what I
can tell is that, if there is a child who is unaccompanied who
comes across the border, it is my responsibility under HHS to
make sure that we provide, for the time that that child is
here--and again, I do not make the decision on whether the
child is sent back or not----
Senator Daines. Do you believe any of your policies have
created incentives and been part of the problem we are seeing
on our southern border?
Secretary Becerra. We are following the law, Senator. The
law was created by Congress. We are going to continue to follow
that law.
Senator Daines. Do you believe any of the changes in policy
of the Biden administration which occurred the first few months
of his administration, have contributed to the crisis we are
seeing on the border?
Secretary Becerra. I appreciate that the President wants us
to follow the law. If we have a broken immigration system, I do
not think you can blame that on the new President, President
Biden. President Biden already put before this Congress a
proposal to reform our immigration laws. A broken system has
created what we find at the border, and we are going to
continue to follow the law we have, especially at HHS, where
our care and our concern is children.
Senator Daines. Thank you, Mr. Chairman.
Senator Crapo. Thank you. And I am told that we might have
a chance to go back and connect with Senator Carper.
Senator Carper, are you available?
Senator Carper. I can hear all of you. The question is, can
you hear me?
Senator Crapo. We can hear you. And I think the Secretary
knows your question. Would you like him to answer the one you
asked before?
Senator Carper. I want to make sure he knows it. I was
saying, a couple of years ago, Mr. Secretary, this committee,
led by Senators Wyden and Grassley, passed bipartisan
legislation to reduce prescription drug prices for Medicare
beneficiaries, lower drug prices for seniors, lower drug prices
for Medicare and Medicaid. It also required drug companies to
make price increases publicly available.
You may recall I spoke with you recently about your
willingness to maybe explore whether or not that bipartisan
agreement, which enjoyed a lot of Democrat support and quite a
bit of Republican support, might be pulled off the shelf,
dusted off in this Congress, and be used to build on for future
legislative efforts in this space. Have you had a chance to
give that any thought, and would you just share your thoughts
on that?
Secretary Becerra. Senator, yes. I appreciate the question.
I have given it a great deal of thought, and we are actually
working right now to try to be supportive of the work that you
are doing, and certainly the work that Senator Wyden and
Senator Grassley have done, so that we can try to see progress
made.
There are any number of proposals that are out there. The
President has made it clear he is supportive of making progress
in reducing the price of prescription drugs. He has been
supportive of negotiating drug prices. He has been supportive
of the efforts in the Wyden and Grassley legislation to try to
deal with high prices through rebates.
We are open. We are ready. We are waiting to see where you
all wish to go as well. And we will be good partners as we try
to help Americans pay less for their prescription medication.
Senator Carper. Well, that is encouraging. I would urge you
to be proactive. There is an option--there is a possibility we
could do something again and build on what we agreed to 2 years
ago.
The second follow-up question is also with respect to
prescription drug prices, Mr. Secretary. The President's budget
calls on Congress to pass legislation to lower prescription
drug prices in part by allowing you, the Secretary of Health
and Human Services, to negotiate directly with pharmaceutical
manufacturers.
However, there has been debate among my colleagues on what
negotiations would actually look like. And as the principal
negotiator in this proposal, share with us some insights as to
what kind of approaches you would take in negotiating to lower
drug prices, and what authorities would you be looking to us in
the Congress for to make this happen?
Secretary Becerra. Senator, the last point you made is
where I think we should start, which is that we will look to
Congress to see how we can get this done. We may have ideas,
and we certainly can provide technical assistance, but there
are any number of approaches when it comes to how you would
negotiate those prices.
H.R. 3, legislation that passed in the House last year,
provides one means. Others have other ideas. All I know is that
the President is anxious to work with Congress to reduce the
cost of prescription medication.
Senator Carper. Thank you so much. Good to see you.
Secretary Becerra. Thank you.
Senator Crapo. Thank you.
And now we have Senator Whitehouse and Senator Warren, in
that order. Senator Whitehouse is online, I hope----
Senator Whitehouse. I am online. Thank you very, very much.
Welcome, Mr. Secretary.
I want to add to the conversation about a public option.
Senator Brown and I actually wrote the original public option
that we came one vote away from getting into the Affordable
Care Act. And we are delighted with Senator Bennet's and
Senator Kaine's activities in this space as well.
And my ask would be that when you have your team assembled
to deal with the public option and look at the specifics of
eligibility and actuarial solvency, that we have a meeting,
that you convene a meeting with your operating people and all
four of our offices so that we can get to the detailed work of
drafting legislation that you and the President could support.
Secretary Becerra. Senator, we will be available to you
whenever you call.
Senator Whitehouse. Do you have a team yet assigned to
public option?
Secretary Becerra. We have a team that has been working on
a number of these different proposals, because we want to be
ready whenever you all might launch.
Senator Whitehouse. All right. Great. Okay. Well, we will
organize the meeting then, and I appreciate it.
You and I have had this conversation before, and you
mentioned it just now, regarding your dad passing away and how
important it was to your family to have him home and to have
support from the health-care system. I had, as you know, the
exact same experience, and it was meaningful to me.
You also talked about local leadership and models. I just
wanted to point out to you that, for the better part of a
decade now I have been working on a model for end-of-life care
that we have pretty well teed up in Rhode Island.
It would be approved through CMMI, because we are asking
for a number of waivers that, while they may be useful--while
the underlying rule may be useful in the abstract, when applied
to an end-of-life population it becomes ridiculous, like the 3-
day/2-night rule, or the ``you've got to commit granny to the
hospital to get respite care'' rule. And what we want to do is
to get a Rhode Island project up and going that combines all
the waivers.
And I think, as you have talked about local leadership and
models, this is a really important thing to me. I know that
CMMI and Ms. Fowler report to you through CMS and Ms. Brooks-
LaSure, but I wanted to mention here the importance of this
committee. I have worked on it for a long time. We are ready to
go. The problem has been, really, turnover at CMMI as
administrations change and personnel have changed.
So I have been in ``Groundhog Day'' with new start after
new start after new start. And this is the moment when I am
actually quite determined to finally land this thing after
circling, and circling, and circling, and circling.
So, I urge you to let your team know that this is important
to me. And I think it is a good project. And if you will take a
close look at it yourself, I think you will see that this is
the kind of thing that you and Ms. Brooks-LaSure and Ms. Fowler
should all give a thumbs-up to.
So, I flag that for your attention, if you don't mind.
Secretary Becerra. Senator, we look forward to working with
you on that. I flagged it for my staff. We will follow up.
Senator Whitehouse. Great. I have been through enough
Groundhog Days on this. I hope you can appreciate that
impatience comes at some point.
The last thing that I wanted to mention to you--and this is
part of a much bigger conversation, I understand--is that we
are hitting in 2024 Medicare insolvency for the first time. We
have massive cost savings from my favorite graph that I have
shown you before, and showed in the committee all the time,
that occurred with the ACA compared to previous projections.
I think that has to do with a lot of the work that we did
in the ACA. The unsung heroes of the ACA were in fact CMMI and
the ACOs. And in Rhode Island we have two particularly stellar
ACOs that are like national best-in-class. So, I am really
eager to make sure that the delivery system reform effort
continues. Because to the extent we can save money through the
famous triple aim by improving care, improving the experience
of patients, and reducing costs--not just the old, you know,
bending the cost curve down, but actually reducing costs--I
think we have shown we can do that. And I am a little bit
discouraged that that delivery system reform emphasis does not
really appear in the budget anywhere. And I really hope that
this is something that we can get serious attention on from
your organization to make sure that we are expanding the ACO
program, expanding the delivery system reform, expanding
payment reform, and making the whole health-care system more
responsive to patients in ways that will actually bring down
costs because it will keep people healthier.
Secretary Becerra. Senator, I can only say that we will
look forward to working with you on any number of those
subjects, and it probably will bring back memories of the work
that I did when I was in the House.
Senator Whitehouse. So we should not take it as a bad
signal, the failure to mention it in the budget?
The Chairman. I thank my colleague from Rhode Island.
The Senator from New Hampshire.
Senator Hassan. Well, thank you, Mr. Chair. I thank you and
the ranking member for this hearing. And thank you, Secretary
Becerra, for being here today.
Secretary Becerra. Thank you.
Senator Hassan. Mr. Secretary, I am pleased to see that the
President's budget requests a 50-percent increase in funding
for State opioid response grants. Since 2017, I have worked
with my colleagues to secure an increase in funding for these
grants, including more than $86 million for New Hampshire. This
funding has enabled States to begin to make progress on
addressing the opioid epidemic by expanding access to life-
saving treatment and services for those struggling with
substance use disorder.
Earlier this year, you and I spoke about ensuring that
States do not experience dramatic cuts in funding from the
State opioid response program, cuts that could jeopardize
critical State initiatives. Unfortunately, the Department of
Health and Human Services has not provided clarity on this
issue in the months since. So the continuity of funding to
States remains uncertain. So let me start by asking this: do
you agree that this uncertainty is problematic? And as
Secretary, will you ensure that States do not experience
dramatic funding cliffs in their State opioid response grants
from one year to the next?
Secretary Becerra. I absolutely agree that it would be
problematic to not address this. But here is the rub: to
address it, we need the funding. And that is where we hope that
the Congress will act on the President's budget request.
Senator Hassan. I hear you on the need for additional
funding as the problem gets worse in some other places, but
let's be clear. You have the authority to adjust these grants
within your current authorization. So, let's just go through
what you think you have the authority to do, and what I think
you have the authority to do, so we can be clear.
Do you agree that HHS has the authority to modify the
number of hardest-hit States in the State opioid response grant
funding formula set-aside?
Secretary Becerra. Senator--and again, thanks to your staff
as well for working with my team. We have a number of
authorities. I think it is easier said than done to say that we
have the authority to make those modifications. Each of those
modifications would have consequences that would impact a
number of other programs and services in States as well.
Senator Hassan. But what we are talking about is States
with very modest reductions in mortality rates from the opioids
having made some progress, and then the possibility of a
dramatic cut really sending them backwards.
So let me tell you what I think you have the authority for,
and then perhaps our staff can follow up on this. I believe you
have the authority to modify the number of hardest-hit States
in the State opioid response grant funding formula set-aside. I
believe you have the authority to ensure that the formula
avoids significant funding disparities between States with
similar mortality rates. That is what we are really talking
about here. And I believe you have the authority to ensure that
States do not experience dramatic cuts in your year-over-year
State opioid response grant funding.
So what I would like to have happen is your team to follow
up with mine, if they differ with our analysis of what
authorities you have.
Secretary Becerra. We will absolutely sit down with your
team, continue to sit down with your team to try to evaluate
those things.
Senator Hassan. Okay. Do you agree we need a solution to
help ensure that States do not face funding cliffs in this
program?
Secretary Becerra. You can see a clear example of that in
the work that we are doing to try to extend the subsidies that
we are providing under the ACA for people who fall over this
cliff because they no longer qualify to get those subsidies for
the ACA coverage.
So we agree absolutely that these cliffs are tremendously
harmful not just to the individuals, but they are harmful to
the system, because regressing is not a good solution.
Senator Hassan. Right. So understanding that you agree we
need a solution, what I would like a commitment from you about
today is that you will provide us with a concrete written plan
to prevent funding cliffs in the State opioid response grants,
and that you will share it with my office.
Secretary Becerra. We will work with your office where we
can head in that direction. Again, I do not know what the
ultimate outcome will be, but we will certainly work with your
staff.
Senator Hassan. Well, what I am looking for is a commitment
to provide a solution. I hope we can do it by the end of this
month. And I am going to be just very frank here. You all have
put forward a wonderful qualified nominee to be the head of
SAMHSA. But if your nominee does not have the backing of the
leadership in her department to make commitments and use the
authority that is in law to prevent States from experiencing a
cliff in their funding, it is going to be really problematic.
So I am hoping that we can get this ironed out and
straightened out in the near future, because it would be a real
shame--without the Department committing to this, what is going
to happen is, we are going to play Whac-A-Mole with our
capacity to deal with the substance use disorder. And I am
concerned that it does not get the same level of commitment,
for instance, that the COVID-19 pandemic got because of the
stigma associated with addiction.
So I would really like to drill down on this, and I would
really like the Department to commit to preventing these
funding cliffs from happening.
Thank you, Mr. Chair.
The Chairman. I thank my colleague. We are going to do
everything we can to get everybody in on this round as we deal
with the second vote. I think Senator Warner is available on
the web?
[No response.]
The Chairman. Senator Warner?
[No response.]
The Chairman. Senator Cortez Masto, on the web.
Senator Cortez Masto. Thank you, Mr. Chair. Secretary
Becerra, thank you. It is great to see you again. And let me
just say this: I really appreciate our conversations we have
had about the lack of access to mental health services across
this country. So I am going to start there with the need for
more mental health and crisis services. And I appreciate the
requested increase in the amount of response grant funding to
help meet the growing need.
I believe--and I know my colleagues are looking at this as
well--we should be looking at funding beyond patchwork grants
and appropriations. We have to improve accessibility to
services under the programs where Americans get their help.
That is why Senator Cornyn and I have introduced the Behavioral
Health Crisis Expansion Act to do just that. It would establish
a continuum of coverage of crisis services, and ensure coverage
of those services.
The bill is with your team right now for technical
assistance. So I look forward to working with you to get this
over the finish line. But let me focus on a piece of the mental
health issue that I am just as concerned about when it comes to
our kids.
In April, MACPAC looked at access to behavioral health
services for children and youth. Their work underscored the
findings in your budget that children are struggling with
increasingly serious mental health challenges. And MACPAC found
that in 2018, 20 percent of adolescent Medicaid beneficiaries
experienced a lifetime major depressive episode and 12 percent
had suicidal thoughts. Nearly 4 percent attempted suicide. So
MACPAC made two recommendations, both of which can be carried
out by HHS at no cost.
They suggest that the agencies at HHS tasked with caring
for kids' mental health--CMS, SAMHSA, and ACF--collaborate to
issue joint guidance and technical assistance to States on
improving access to services. So my question to you is, does
the agency have plans to carry out those recommendations? And
if not, what do you intend to do to really bring the necessary
services to our children?
Secretary Becerra. Senator, thanks for your concern and
interest on this issue, long-term concern and interest. You may
have heard, about a month ago I announced that, within HHS, we
were establishing the Behavioral Health Coordinating Committee
so that we would take the various agencies involved--whether it
is SAMHSA, whether it is CMS with Medicaid, whether it is the
Children and Families Administration--and we are going to work
together to coordinate those services so that we do this as
MACPAC suggested, with one goal in mind, and not having
disparate agencies doing different things. We have also got a
coordinating committee within that that will focus on children
and youth.
Senator Cortez Masto. Secretary Becerra, thank you. That is
great news. Can I add one more thing, that IT is essential?
After being home and talking with, not only students but our
school districts and our State department of education--and
this follows up on a letter that I sent to both you and
Secretary Cardona to work together to ensure that--listen, we
made significant investment over this last year to various
COVID relief packages, and most recently, the American Rescue
Plan. And part of that money is going into our schools. And my
goal is to ensure that some of that funding goes to really
ensure that we are providing effective mental health support
for our students.
And so my hope is that, as part of the American Rescue Plan
dollars now getting distributed, working with the Department of
Education, you are tracking those dollars to ensure that
schools are investing in mental health support.
So my question to you: is that something that you are also
looking at? And if not, I hope that you do, and that
collaboration with the Department of Education is going to be
key.
Secretary Becerra. Senator, you will pleased to know that
next week Secretary Cardona and I are going to be doing a joint
event where we are going to try to really push on the whole
idea that these investments that we are making could just be
tremendously helpful for so many families and our children.
I should also mention that we are asking for additional
funding within our budget for the Community Mental Health
Services Block Grant to try to address this. And you are
probably aware that, about a month ago, we announced a $3-
billion let-out of money, half of it for mental health
services, half of it for substance use disorders, to try to
address the services that we need back home.
Senator Cortez Masto. Thank you. I know my time is running
out. I will submit the rest of my questions for the record that
include so many other things, but thank you again.
[The questions appear in the appendix.]
The Chairman. I thank my colleague for her thoughtfulness.
Now Senator Warren, who has also been very patient.
Senator Warren. Thank you very much. Thank you, Mr.
Chairman, and thank you for being here, Mr. Secretary.
So President Biden's budget proposes a historic investment
in the American people. When it comes to health care, the
President has called on Congress to do more, especially for
Medicare. Now Medicare is very popular, but it is not perfect,
especially when it comes to covering the services that older
Americans need.
For example, 50 percent of people aged 75 or older have a
disabling hearing loss. But Medicare does not offer a
comprehensive hearing benefit. It also does not cover full
dental or vision services, even though 70 percent of seniors
have no dental insurance, and older Americans are at increased
risk for severe eye problems.
So that is why the President, as part of his budget, called
on Congress to, quote, ``improve access to dental, vision, and
hearing coverage in Medicare.''
So, Secretary Becerra, let me ask you, how would expanding
Medicare coverage to include vision, dental, and hearing
services improve the health and well-being of Medicare
beneficiaries, especially low-income beneficiaries and seniors
in medically underserved groups?
Secretary Becerra. Well, Senator, I think, as we have
discussed in the past and I think the President has made very
clear, we have ways that we can expand these services, and in
fact we must, because we know it is to our own benefit to
provide these preventative services as early as possible to our
seniors.
What I can tell you is that there are ways to pay for these
additional services. We have discussed some of those as well in
the past. If you were to save money on prescription drug
medication by negotiating prices, or providing that the
industry must provide rebates when it increases prices too
quickly, you start to develop the resources you need to pay for
things like providing access to dental health services, vision
services, hearing services.
So, we are looking forward to working with you to make sure
that we continue to make Medicare even better. And where we go,
I know that will really depend on Congress, but we are ready.
Senator Warren. Good. I am glad to hear that. I think that
is terrific. Expanding Medicare to cover health conditions that
affect seniors is an obvious move, and it is the right thing to
do, which is why the President has called on Congress to do it.
But it is not just people 65 and over who need better
access to care. There are plenty of people just shy of Medicare
age who need better hearing, dental, and vision coverage, along
with all the other benefits that Medicare has to offer.
President Biden's budget also calls on Congress to give
people aged 60 and up the option to enroll in Medicare, a
policy that some analysts predict would give 23 million people,
including nearly 2 million previously uninsured people, access
to the program.
So, Mr. Secretary, why is it so important that Congress
follows through on this proposal?
Secretary Becerra. Senator, for all the reasons we now know
as a result of COVID. We have too many Americans who do not
have any coverage, and too many Americans who do not have
enough coverage. And the worst thing we can do is allow our
family members who are reaching the age of qualifying for
Medicare but are not quite there, who typically are going to be
more at risk of suffering from a health condition, the lack of
access to the kind of care that they will need.
The President, as you mentioned, has been supportive of
having the public option of having those 60 and older apply for
Medicare. He has mentioned on many occasions that he is open to
considering so many different ideas. But what he wants is for
us to get something done.
Senator Warren. Good. I like that. I strongly agree with
President Biden. Congress should expand Medicare to include
vision, hearing, and dental coverage. And it should lower the
age of Medicare. In fact, I think we should go lower than the
President proposed to age 55.
Now President Biden also wants Congress to let Medicare
negotiate payments for high-cost Part D drugs, something you
referred to earlier, Mr. Secretary. But big pharma is lobbying
hard to maintain the status quo.
So let me ask you, Mr. Secretary, as Congress crafts
legislation to lower drug prices, the pharmaceutical lobbyists
are out there fear-mongering and pressing us to pass some
watered-down bill that fails to tackle drug pricing head-on.
How do you think Congress should respond? Are we going to go
with these half measures? Or do you think we should pass a
strong negotiation bill that implements the President's agenda?
Secretary Becerra. Senator, I think COVID-19 has taught us
so many different things, and continues to teach us. And we see
what happens when we are not prepared. I do not think anyone
wants the American public to not be prepared to face down,
whether it is a pandemic or something as serious as making sure
that all of us have access to the prescription medication we
need.
We will leave it to Congress, but we think this is an
opportunity to make a generational change in how we do business
when it comes to prescription medication.
Senator Warren. Good. I am glad to hear that, Secretary
Becerra. I agree. The time for delays, and half measures, and
equivocating, and industry-friendly legislating, is over. It is
time for Congress to step up and put President Biden's Medicare
priorities into action.
And I do not just mean some of the priorities. I mean all
of them: authorizing drug price negotiation with real muscle,
expanding Medicare benefits, and lowering the eligibility age.
As you say, we have an opportunity here to dramatically improve
the Medicare program, and we should not waste it by being
afraid to take on interest groups that are profiting off our
current system.
I appreciate your being here today, Mr. Secretary.
The Chairman. The time of my colleague has expired.
Senator Scott, I believe you are next.
[No response.]
The Chairman. Senator Scott, one more time?
[No response.]
The Chairman. Senator Young, or Senator Burr?
[No response.]
The Chairman. All right, let me just do one more check.
Senator Warner, are you on the web?
[No response.]
The Chairman. Can staff report that any colleagues are
seeking to ask questions, either on the web or in person?
Democratic side? Republican side?
[No response.]
The Chairman. Okay.
Mr. Secretary, you gave us a number of pieces of positive
news. Vaccinations have taken off during the Biden
administration. Now half, approximately, of Americans have been
vaccinated. The Affordable Care Act enrollments are up, with 30
million now covered. And the Biden administration has made a
commitment to something I have been interested in since the
days when I was co-
director of the Gray Panthers, and that is a real seamless
system of home and community-based services.
And Senator Casey has been our champion on this here in the
committee, and I look forward to the day when families can
really have access to a wide array of choices for their
relatives. They may decide on home care. They may decide on
traditional nursing home care. Some will need, for perhaps
short periods of time, nursing home care that is almost like a
hospital. Some will look at assisted living. But we are very
interested in working closely with you on that.
Now, having mentioned what strikes me as clearly good news
and moving in the right direction, we still have some very
serious challenges. And they have really been highlighted by
this Alzheimer's drug approval. Because here you have
essentially skimpy evidence for a drug that, in one big bite,
is going to cost so much that it will gobble up the Medicare
Part B budget, gobble it up and then some, raising the question
of course that we are going to have breakthroughs--and not
something with skimpy evidence. But we are going to have
scientific breakthroughs, and we want to make sure the American
people can afford to actually get them, that the fruits of that
spectacular work by the scientists are actually available.
Today I have been just flooded with questions with respect
to the FDA nominee. And it is possible to have an acting
Commissioner a bit longer. I think it is critically important
that we get that nominee, because there are questions that the
American people have with respect to the evidence and how we
are going to make sure these medicines are affordable.
But you and I have worked together for a long time, and we
enjoyed service in the Congress, and I think we know some
practical steps forward. In this committee, Senator Grassley
and I were able to get Senators to say that when the
pharmaceutical companies are price-gouging on drugs like
insulin, which has gone up 12-fold in price in recent years,
and the drug is not 12 times better, they are going to lose
their subsidies, and there is going to be a rebate. And I also
strongly support the idea that, with Medicare and 50 million
seniors, we ought to lift that restriction, and Medicare should
negotiate.
Now, as I tried to find common ground with my colleagues, I
talked to Senator Crapo and Republicans and Democrats alike; I
welcomed their ideas here in this committee. We will work
closely with you on it, Mr. Secretary, and we look forward to
continuing our work with you and to build on the positive news
that you gave us today, recognizing we have some very heavy
lifting, particularly in terms of taking on some of the big,
entrenched lobbies in health care so that we can make real
changes that help people by lowering drug prices, and we will
look forward to working with you in the future.
With that, the Finance Committee is adjourned.
[Whereupon, at 12:23 p.m., the hearing was concluded.]
A P P E N D I X
Additional Material Submitted for the Record
----------
Prepared Statement of Hon. Xavier Becerra, Secretary,
Department of Health and Human Services
Chairman Wyden, Ranking Member Crapo, and members of the committee,
thank you for the opportunity to discuss the President's Fiscal Year
(FY) 2022 budget for the Department of Health and Human Services (HHS).
I am pleased to appear before you, and I look forward to continuing to
work with you.
HHS is at the center of many challenges facing our country today--
the COVID-19 pandemic, safely caring for unaccompanied children at our
southern border, the overdose and addiction epidemic, gun violence,
racial inequality, and more--and we are rising to meet those
challenges. I am honored to be given the responsibility to lead HHS at
this time.
COVID-19 has shed light on how health inequities and insufficient
Federal funding can leave communities vulnerable to crises. The
President's budget invests in America, demonstrates a conscious effort
to address racial disparities in health care, tackles the opioid and
other drug crises, and puts us on a better footing to take on the next
public health crisis.
Now more than ever, we must ensure that HHS has the resources to
achieve its mission and tackle these challenges after years of
underfunding. The President has put forward a budget that does just
that. The FY 2022 budget proposes $131.8 billion in discretionary
budget authority and $1.5 trillion in mandatory funding. The Labor-HHS
total is $119.5 billion, an increase of $23 billion. Investments in the
budget support families in areas such as behavioral health (mental
health and substance use), maternal health, emerging health threats,
science, data and research, tribal health, early child care and
learning, and child welfare.
To build back a prosperous America, we need a healthy America, and
President Biden's budget builds on that vision while investing in the
many programs housed at HHS to save lives.
preparing for and responding to public health crises
The fight against COVID-19 is not yet over. Even as HHS works to
beat this pandemic, we are also preparing for the next public health
crisis. The FY 2022 budget makes significant investments in our
preparedness and response capabilities.
The Strategic National Stockpile, within the HHS Office of the
Assistant Secretary for Preparedness and Response, has served a
critical role in the COVID-19 response, permitting rapid deployment of
personal protective equipment, ventilators, and medical supplies to
States, cities, tribes, and territories across the country. The budget
provides $905 million for the stockpile, $200 million above FY 2021, to
ensure that the stockpile is ready to respond to future pandemic events
and any other public health threats while maintaining a robust
inventory of critical medical supplies, enhancing visibility of the
domestic supply chain, and modernizing the stockpile's distribution
model. In addition, the budget provides $823 million, $227 million
above FY 2021, for the Biomedical Advanced Research and Development
Authority, which has supported the development of new vaccines,
therapeutics, and diagnostics for the COVID-19 response. Additional
resources will support improved medical countermeasure platforms that
will enable quicker, more effective detection and public health and
medical responses to health security threats. The budget also supports
a strong public health workforce, and addresses gaps in the existing
public health infrastructure, including at the State and local levels.
In addition to discretionary investments, the budget includes $30
billion over 4 years in mandatory funding for HHS, the Department of
Defense, and the Department of Energy to protect Americans from future
pandemics and create U.S. jobs through major new investments in medical
countermeasures manufacturing; research and development; and related
biopreparedness and biosecurity investments.
During this pandemic, we have seen the critical role of the Centers
for Disease Control and Prevention (CDC). To ensure that CDC is well
positioned to address current and emerging public health threats, the
budget restores capacity to the world's preeminent public health agency
by investing an additional $1.6 billion over the FY 2021 level for a
discretionary funding total of $8.7 billion. This is the largest budget
authority increase for CDC in almost 2 decades. A core function of CDC
is partnering with State, tribal, local, and territorial entities, and
this funding will enhance those partnerships. The budget will also
provide CDC with additional resources to further develop and expand
teams of highly trained and deployable public health experts to support
preparedness at the local level.
The COVID-19 pandemic has also shown the importance of producing
reliable data. Bad inputs lead to bad outputs, and without good data,
CDC cannot effectively prepare for, or respond to, public health
threats and make well-informed decisions to protect the American
people. With funding provided in the FY 2022 budget, CDC will build
upon previous investments in the data infrastructure to date and
continue efforts to modernize public health data collection and
analysis nationwide.
Public health threats know no borders, and CDC is working to
prevent, detect, and respond to epidemic threats at home and abroad.
With CDC experts embedded in countries around the world, CDC is
supporting global COVID-19 response by leveraging core public health
capacities and relationships built through decades of CDC global health
activities. As we continue to confront new and emerging COVID-19
variants, as well as a surge of cases in India, support for CDC's work
is even more important. CDC is working closely with U.S. government
agencies, ministries of health, and other partners to assist countries
in responding to COVID-19, while simultaneously developing and
implementing adaptations to interventions for malaria, HIV, and
vaccine-preventable diseases. With the President's proposed FY 2022
investments, CDC will not only address preparedness within the United
States, but will also support core public health capacity improvements
overseas and strengthen global health security by improving our ability
to deploy experts internationally and support efforts to prevent,
detect, and respond to emerging global biological threats. CDC will
invest in global health security and continue to fight health threats
worldwide while simultaneously enhancing domestic preparedness to
address threats here at home. Domestic health is increasingly impacted
by global factors and CDC's global health security efforts include
conducting research to ensure efficient disease response.
The Assistant Secretary for Preparednes and Response (ASPR) and CDC
investments complement preparedness activities across HHS including
basic and clinical research within National Institutes of Health (NIH)
and activities within the Food and Drug Administration (FDA) to advance
regulatory science and mitigate potential supply or drug shortages.
While we prepare for future pandemic threats, we are also facing a
public health crisis that is already here: violence in our communities.
The current public health emergency has shone a light on the issue of
domestic and gender-based violence. More than one in four women and
more than one in 10 men have experienced contact sexual violence,
physical violence, or stalking by an intimate partner and reported
significant impacts. The budget provides $489 million for the
Administration for Children and Families (ACF) to support and protect
domestic violence survivors, which is more than double the FY 2021
enacted levels. The budget also provides $66 million for victims of
human trafficking and survivors of torture, more than 45 percent above
FY 2021 enacted levels.
We have also seen the devastating impact of gun violence in
communities across the country. Almost 40,000 people die as a result of
firearm injuries in the United States every year, while homicide is the
third leading cause of death for people ages 10-24. This is a public
health issue, and one that disproportionately impacts communities of
color. The budget addresses this crisis by doubling CDC and NIH funding
for firearm violence prevention research. The budget provides $100
million in discretionary funding to CDC to start a new Community
Violence Intervention initiative, in collaboration with the Department
of Justice, to implement evidence-based community violence
interventions at the local level. In addition to the discretionary
investment for the Community Violence Intervention initiative, the
budget includes a total of $5 billion in mandatory funding for CDC and
the Department of Justice, beginning in FY 2023 and continuing through
FY 2029.
The climate crisis has real public health impacts, and HHS's
mission depends on healthy and sustainable environments. HHS thus has a
major role to play in the administration's government-wide effort to
tackle this crisis. HHS's investments to combat climate change in the
FY 2022 budget will advance health equity, lay the foundations for
economic growth, and ensure that benefits from tackling the climate
crisis accrue to tribal communities, communities of color, low-income
households, and disadvantaged communities that have been marginalized
or overburdened. The budget includes a $100 million increase in NIH
funding to support research aimed at understanding the health impacts
of climate change, as well as an additional $100 million investment in
CDC's Climate and Health program to support efforts to understand and
identify potential health effects, including children's environmental
health considerations associated with climate change and implement
plans to adapt to a changing environment. The American Jobs Plan also
would invest $1.5 billion to increase the resilience of hospitals and
critical infrastructure, fund health emergency preparedness cooperative
agreements, and build resilience including in relation to the effects
of a changing climate.
caring for all americans through health and human services
Central to the HHS mission is the charge to enhance the health and
well-being of all Americans. The budget invests in areas across HHS to
ensure that we are equitably serving the American people. As Secretary,
I will ensure that this focus is fundamental to all of our work.
A critical part of this is investing in civil rights enforcement to
ensure that all people receiving services from HHS-conducted or HHS-
funded programs, no matter who they are, or where they live, can
receive health care free from discrimination.
The FY 2022 budget makes expanding affordable health-care access a
priority across Centers for Medicare and Medicaid Services programs. A
recently released report titled ``Health Coverage Under the Affordable
Care Act: Enrollment Trends and State Estimates'' shows that the
Affordable Care Act (ACA) has expanded health insurance coverage to
millions of Americans, and the budget goes even further. It builds on
the groundbreaking reforms introduced in the American Rescue Plan Act
by extending the enhanced premium subsidies that put affordable health-
care coverage within reach of millions more Americans. These
improvements in the American Rescue Plan Act are lowering premiums for
more than 9 million current enrollees by an average of $50 per person
per month. In addition, due to the COVID-19 pandemic, an ongoing
opportunity to apply for enrollment in marketplace health-care coverage
is available on HealthCare.gov through August 15th. This extension
provides individuals and families a desperately needed opportunity to
get quality, affordable health insurance coverage. As of May 10th, over
1 million additional Americans have signed up for health insurance
through the marketplace, and an additional 2 million obtained improved
benefits through the marketplace, benefiting from both reduced premiums
and more affordable cost sharing.
The FY 2022 budget also expands access to critical home and
community-based services (HCBS) under Medicaid, critical health-care
services that allow older people and people with disabilities to live
independently in their homes and communities. The budget builds on the
additional Medicaid funding included in the American Rescue Plan that
not only expands access to these important services but also
strengthens State HCBS programs by allowing States to use the
additional money to, for example, provide additional benefits, like
mental health and substance use services, to beneficiaries, as well as
to raise wages and provide paid leave for home care workers.
I look forward to working with the Congress to achieve the
administration's goal of lower costs and expanded and improved coverage
for all Americans. This includes reforms to lower the costs of
prescription drugs, such as allowing Medicare to negotiate payment for
certain high-cost drugs, and requiring manufacturers to pay rebates
when drug prices rise faster than inflation. We will also work to
improve Medicare, Medicaid, CHIP, and private insurance coverage, by
pursuing changes such as improving access to dental, hearing, and
vision coverage in Medicare, making it easier for eligible people to
get and stay covered in Medicaid, promoting Early and Periodic
Screening, Diagnostic and Treatment (EPSDT) requirements for eligible
youth, and reducing out-of-pocket costs for individuals in private
insurance coverage obtained through the marketplace. The administration
also supports additional public coverage options, including a public
option that would be available through the insurance marketplaces.
Health care is a right, not a privilege, and I will work to ensure that
families across the Nation are able to secure this right.
The United States has the highest maternal mortality rate among
developed nations, with an unacceptably high mortality rate for black
and American Indian/
Alaska Native women. Addressing this critical public health issue is a
major priority of this administration, as evidenced by the American
Rescue Plan's State option to extend Medicaid postpartum coverage.
Building on HHS's longstanding efforts to improve maternal health,
including the Department's recent Medicaid postpartum waiver approvals,
the budget provides more than $220 million in discretionary funding to
reduce maternal mortality and morbidity by implementing evidence-based
interventions to address critical gaps in maternity care service
delivery and improve maternal health outcomes. This includes increased
funding to CDC's Maternal Mortality Review Committees and the Health
Resources and Services Administration's (HRSA) Rural Maternity and
Obstetrics Management Strategies program. HRSA also prioritizes
maternal health through its title V Maternal and Child Health Block
Grant and Alliance for Innovation on Maternal Health programs. As with
all our public health work, collecting good data will be critical. In
addition to these discretionary resources, the budget includes $3
billion in mandatory funding over 5 years, to invest in maternal health
and reduce the maternal mortality rate and end race-based disparities
in maternal mortality.
HRSA's work is central to our focus on serving all Americans, given
their mission to improve health outcomes and address health
disparities. HRSA-funded health centers provide access to care for low-
income and marginalized populations, and they serve one in 11 people in
the Nation. The President's budget increase to workforce diversity
programs highlights HRSA's commitment to supporting health-care
providers dedicated to working in underserved areas and building toward
a workforce that reflects the communities it serves and is able to
provide culturally relevant care.
The budget provides $670 million across HHS to continue efforts to
end the HIV epidemic in the United States by working closely with
communities that have high rates of HIV transmission to implement
effective prevention, diagnosis, and treatment strategies, including
ones that address the disproportionate impact of HIV and hepatitis C
infections in tribal communities. HHS programs have already made major
progress in combating the HIV epidemic. HRSA ensures equitable access
to services and supports for low-income people with HIV through health
centers as well as the Ryan White HIV/AIDS Program. In 2019, 88.1
percent of those served under the Ryan White HIV/AIDS Program had
achieved viral suppression, a record level that exceeds the national
average of 64.7 percent. HHS will build on this work to end the
epidemic once and for all.
Also, directly connected to the HHS mission is the need to provide
access to high-quality care, no matter where you live. HHS will
continue to focus on the unique needs of rural communities. HHS
administers a range of programs that address rural health, from those
that serve large populations such as health centers, to those serving
targeted populations such as the Black Lung Clinics Program. The FY
2022 budget serves active, inactive, retired, and disabled coal miners
and their families through high-quality medical, outreach, educational,
and benefits counseling services. It also provides funding to increase
the number of individuals receiving training and serving in health
professions in rural communities, as research has shown that providers
are likely to remain in the communities where they train as residents.
HHS will also address the stark health disparities that persist in
tribal communities by investing in the Indian Health Service (IHS),
which serves over 2.6 million American Indians and Alaska Natives. The
COVID-19 pandemic's devastating impact on tribal communities has
demonstrated the real human toll of these disparities. The budget
provides a $2.2 billion, or 36 percent, increase for IHS in order to
take a historic step to address chronic underfunding, expand access to
high-quality health care, and address critical facilities and
information technology infrastructure deficiencies across Indian
country. For the first time, the budget also proposes advance
appropriations for IHS to provide stability for the Indian health
system and parity with how other Federal health agencies are funded. I
am committed to strengthening the nation-to-nation relationship between
the United States and Indian tribes. To this end, the budget supports
self-determination through a consultative process to consider long-term
solutions, including mandatory funding, to ensure adequate and stable
funding for IHS.
The budget also provides an 18.7-percent increase to the title X
family planning program to improve access to vital reproductive and
preventive care and to advance gender equity. Over the last 2 years,
nearly half of the programs supported by title X lost providers as a
result of the 2019 regulation which added burdensome restrictions
inconsistent with quality care guidelines and ultimately resulted in
many highly qualified, longstanding health-care entities to exit title
X. The budget allows title X to not only restore highly qualified
providers, but also to expand its essential services to meet increased
demand as a result of the global pandemic and resulting recession. In
2019, title X-funded clinics served almost 3.1 million Americans, 66
percent of whom had incomes at or below the Federal poverty level and
41 percent of whom were uninsured. This is nearly 1 million fewer
people served than in 2018.
investing in children's futures
Our experiences as children shape the adults we become, and support
in childhood can mean success in the future. As Frederick Douglass
wrote, ``It is easier to build strong children than to repair broken
men.'' High-quality early care and education lay a strong foundation so
that children can take full advantage of education and training
opportunities later in life. The American Jobs Plan and the American
Families Plan invest in school and child care infrastructure and
workforce training, and ensure that low and middle-income families pay
no more than 7 percent of their income on high-quality child care.
These investments include $200 billion over 10 years for a national
partnership with States to offer free, high-quality, accessible, and
inclusive preschool to all 3- and 4-year-olds, benefiting 5 million
children. The budget also invests $250 billion over 10 years to make
child care affordable.
The budget also provides $19.8 billion in discretionary funding for
the Department's early care and education programs in ACF, $2.8 billion
over FY 2021 enacted. This includes $11.9 billion for Head Start, which
helps young children enter kindergarten ready to learn. Head Start
programs deliver services through 1,600 agencies in local communities,
and they provide services to more than a million children and pregnant
women every year, in every U.S. State and territory. In addition, the
budget provides $7.4 billion for the Child Care and Development Block
Grant, $1.5 billion over FY 2021 enacted, to expand access to high-
quality child care for families in all corners of the country. Over a
million children receive child care subsidies every month funded by the
Child Care and Development Fund, and nearly half of the families
receiving child care subsidies reported income below the Federal
poverty level. These investments will improve outcomes for children
across the country.
The budget also invests in improvements to the child welfare
system, particularly to address its racial inequity. The budget
provides $100 million in new competitive grants for States and
localities to advance reforms that would reduce the overrepresentation
of children and families of color in the child welfare system and
address the disparate experiences and outcomes of these families. This
funding will also give more families the support they need to remain
safely together. The budget also provides $200 million for States and
community-based organizations to respond to, and prevent, child abuse,
over 30 percent above FY 2021 enacted.
combating mental health and substance use crises
HHS must address the public health crises associated with mental
health and substance use disorders. This need is especially urgent
given that both crises have accelerated during the COVID-19 pandemic.
Calls to mental health helplines have increased across the country as
Americans struggle with increased anxiety, depression, risk of suicide,
and trauma-related disorders resulting from the pandemic. Younger
adults, racial minorities, essential workers, and unpaid adult
caregivers are particularly impacted. Similarly, preliminary data from
2020 suggests that overdose deaths, which were already increasing,
accelerated at an unprecedented rate during the pandemic. Provisional
data suggest that over 90,000 drug overdose deaths occurred in the
United States in the 12 months ending in September 2020. That
represents a year-over-year increase of close to 29 percent.\1\ This
crisis is also evolving--overdose deaths involving substances other
than opioids are also increasing. HHS will ensure that our work is
responsive to the needs of communities across the country.
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\1\ Centers for Disease Control and Prevention. (2021). Vital
Statistics Rapid Release: Provisional Drug Overdose Death Counts.
Retrieved May 6, 2021 at https://www.cdc.gov/nchs/nvss/vsrr/drug-
overdose-data.htm.
The budget addresses these crises through investments in the
---------------------------------------------------------------------------
Substance Abuse and Mental Health Services Administration.
In a historic investment, the budget provides $1.6 billion to the
Community Mental Health Services Block Grant to respond to the systemic
strain on our country's mental health care system--more than double the
FY 2021 level. To address the undeniable connection between the
criminal justice system and mental health, the discretionary request
will also invest in programs for people involved in the criminal
justice system. HHS will also focus on the behavioral impact of COVID-
19, including on children. When children and young people face Adverse
Childhood Experiences (ACEs) such as trauma, it can continue to affect
them across their lifespan, so it is critical we intervene now to
support their social, emotional, and mental well-being.
The budget also takes action to address addiction and the overdose
epidemic, investing $11.2 billion across HHS, $3.9 billion more than in
FY 2021, including $3.5 billion for the Substance Abuse Prevention and
Treatment Block Grant, which has historically failed to keep up with
increases in the cost of providing substance use care to America's
neediest citizens. For the first time, the budget includes a 10-
percent set-aside for recovery support services, a critical step for
building and sustaining the Nation's recovery support services
infrastructure. The block grant remains a critical source of funding
for States, tribes, and territories to provide prevention, treatment,
and recovery support services to their citizens. The impact of this
epidemic is felt in our communities, and the budget will direct funding
to States and tribes to increase community-level response. The budget
will also increase access to medications for opioid use disorder and
expand the behavioral health provider workforce, particularly in
underserved areas. I greatly appreciate the investments the American
Rescue Plan Act provided to the Substance Abuse Prevention and
Treatment Block Grant, Mental Health Block Grant, and Certified
Community Behavioral Health Centers, and HHS will continue to build on
these efforts.
promoting biomedical research
HHS's work is responsible for major scientific breakthroughs, and
we are committed to supporting innovative science and research in order
to advance the health and well-being of our Nation. As the world's
premier biomedical research agency, NIH will continue to be at the
forefront of scientific advancements. The budget includes $52 billion
for NIH, a $9-billion increase or 21-percent increase over FY 2021
enacted. Included in this increase is $6.5 billion to establish the
Advanced Research Projects Agency for Health (ARPA-H). With an initial
focus on cancer and other diseases such as diabetes and Alzheimer's,
this major investment in Federal research and development will leverage
ambitious ideas to build transformational platforms, capabilities, and
resources to speed the application and implementation of health
breakthroughs and shape the future of health and medicine in the U.S.
This bold new approach will complement NIH's existing research
portfolio, which is a vital contributor to longer and healthier lives,
supports and trains world-class scientists, and drives economic growth.
Outside of ARPA-H, the remaining $2.5-
billion increase will allow NIH to continue investing in basic research
and translating research into clinical practice to address the most
urgent challenges, such as HIV/AIDS and ending the opioid crisis.
restoring america's promise to refugees
HHS plays a critical role in promoting the wellbeing of those
seeking refuge or relief in the U.S. The FY 2022 budget provides over
$4.4 billion to the Office of Refugee Resettlement (ORR)--an increase
of over $2.5 billion above FY 2021 enacted. This funding would allow
ORR to support an increase in the refugee admissions ceiling to 62,500
this fiscal year and to continue to rebuild the resettlement
infrastructure in order to resettle up to 125,000 refugees in FY 2022.
This funding increase also reflects a commitment to ensuring that
unaccompanied children are provided with care and services that align
with child welfare best practices while they are in ORR's custody, and
unified with relatives and sponsors as safely and quickly as possible.
Despite significant challenges posed by COVID-19 and policies from the
previous administration, HHS is humanely caring for unaccompanied
children while working to unite them with a vetted sponsor. Working
across government and in close partnership with the Department of
Homeland Security, we have substantially increased our ability to
quickly facilitate the transfer of children out of U.S. Customs and
Border Patrol custody and into child-appropriate settings, including
with fully vetted sponsors.
funding core program operations
It is simply not possible to meet the HHS mission and address all
these key changes without sufficient funding to cover our operational
needs. The FY 2022 budget invests to bolster operations. It strengthens
administrative and operational resources throughout the Department
needed to ensure proper stewardship of resources entrusted to HHS by
Congress.
providing oversight and program integrity
Given the magnitude of HHS's work--and the taxpayer dollars used to
fund it--it is critical that we ensure that our funds are used
appropriately. The budget invests in program integrity, including
efforts to combat fraud, waste, and abuse in Medicare, Medicaid, and
private insurance.
conclusion
I want to thank the committee again for inviting me to discuss the
President's FY 2022 budget for HHS, which offers a comprehensive fiscal
vision for the Nation that reinvests in America's health, supports
future growth and prosperity, and meets U.S. commitments in a fiscally
sustainable way. I look forward to continuing to show how HHS helps
fulfill that vision.
______
Questions Submitted for the Record to Hon. Xavier Becerra
Questions Submitted by Hon. Ron Wyden
Question. On a bipartisan basis, the Senate Committee on Finance
worked tirelessly to get the Family First Prevention Services Act of
2018 (FFPSA) into law so that more families could stay together and not
need foster care when it is unnecessary. Congress intended the
prevention services funded under FFPSA to help address the alarming
overrepresentation of black and American Indian children in our
Nation's child welfare system. Unfortunately, the limited number of
programs and services currently rated by the title IV-E Prevention
Services Clearinghouse and allowable for Federal reimbursement under
FFPSA prevents States from utilizing culturally sensitive programs that
are best equipped to support families of color. I was encouraged to see
that the President's budget includes a new $100-million competitive
grant to address racial inequity in our child welfare system.
How will this new competitive grant support FFPSA implementation?
Answer. FFPSA implementation is a key component in maximizing early
supports to advance the health and well-being of families and prevent
involvement in the child welfare system and HHS is focused on
supporting implementation. HHS has encouraged child welfare agencies to
engage in broad based planning with other child and family serving
agencies in designing their title IV-E Prevention Plans. The
opportunity to implement prevention services under FFPSA opened the
possibility for jurisdictions to assess their service array to
determine how to better meet the needs of communities, and to do so in
partnership across programs, many of which are serving the same
populations. The proposed competitive grant program to advance racial
equity in child welfare and reorient systems towards a prevention-first
model would incentivize State, local, and tribal child welfare agencies
to partner with other government and community stakeholders across the
education, health, human services, and early childhood sectors to
implement prevention services with a focus on advancing equity in child
welfare, including through culturally sensitive programs that might not
yet be rated by the Clearinghouse. This budget proposal complements the
goals of FFPSA and HHS looks forward to working with the committee to
continue to improve outcomes for all children.
Question. What other activities or efforts is your department
considering to increase the number of evidence-based programs that have
demonstrated positive outcomes for families of color and to ensure
States have access to FFPSA dollars for the culturally sensitive
programs and services they want to use?
Answer. Ensuring that our programs have positive outcomes for
communities of color and that States have access to funding to help
promote and implement culturally sensitive programs and services is a
priority for the Department. The Department is undertaking several
steps to work towards equity in our programs and services. Part of this
work is ensuring that we have rules that protect access and promote
nondiscrimination in our programs and services. Further, we have the
Prevention Services Clearinghouse, whose goal is to review and rate as
many programs and services as quickly as possible to support States'
efforts to improve outcomes for children and families through
implementation of the FFPSA. The Prevention Services Clearinghouse
website includes the working list of programs and services that are
currently under review. This information can be found on the About page
of the Prevention Services Clearinghouse website.
Please note that the Children's Bureau released Information
Memorandum ACYF-CB-IM-21-04 to support the need for prevention services
in Indian country as native children are the most overrepresented
minority population in foster care in the United States. Nationally
native children are three times more likely to enter foster care than
white children. Native communities have been among the hardest hit by
the pandemic nationally and are suffering disproportionately with
illness, high mortality rates, and economic distress. All of these
heighten the need and urgency for prevention services in Indian
country. The purpose of the Information Memorandum is to clarify how
allowable adaptations to evidence-based programs and services that have
been rated by the Prevention Services Clearinghouse can be used to
provide flexibility for tribal communities under State title IV-E
prevention programs, and to encourage State IV-E agencies to identify
with tribes which services will be most helpful and to work with tribes
to make allowable adaptations to services that will be responsive to
tribal culture.
The Children's Bureau continues to receive and respond to
recommendations from the field regarding the evidence-based programs
that can be reviewed by the Prevention Services Clearinghouse. The
Children's Bureau is also engaged in efforts that may further explore
and be responsive to underserved populations to address longstanding
equity issues that have been well documented in child welfare services
through discretionary and formula grant programs. HHS and the
Children's Bureau welcomes the continued partnership of the committee
as we implement FFPSA and focus on advancing equity in child welfare.
Question. I have long opposed a harmful rule finalized by the Trump
administration (RIN 0991-AC16) that would remove Obama-era
nondiscrimination protections from HHS-funded grant awards (45 CFR
75.300 (c) and (d)). This final rule would allow sweeping taxpayer-
funded discrimination based on sex (including sexual orientation and
gender identity) and, in the case of foster and adoptive parents,
religion. These regulatory changes could make it difficult for
vulnerable populations, like LGBTQIA+ communities and religious
minorities, from accessing vital programs and services funded by the
Department of Health and Human Services (HHS). The final rule was set
to go into effect on February 11, 2021, and I applaud HHS for
consenting to a court order staying its effective date until August 11,
2021. Yet, at the same time as this rulemaking was announced in 2019,
HHS under the Trump administration issued a Notification of
Nonenforcement immediately stopping enforcement of 45 CFR 75.300 (c)
and (d). To date, HHS has not rescinded the Notification of
Nonenforcement.
What is your plan to reverse the Notification of Nonenforcement,
initiate new rulemaking to retain robust nondiscrimination protections
for HHS-funded programs and services, and eliminate other
discriminatory policies in place at HHS (such as waivers for specific
States to nondiscrimination requirements in 45 CFR 75.300 (c) and (d)
based on sexual orientation and gender identity and on religion)?
Answer. In response to President Biden's Executive Order 13988
(Preventing and Combating Discrimination on the Basis of Gender
Identity or Sexual Orientation), issued on his first day in office, the
Department of Health and Human Services is reviewing all of its
regulations, policies, and agency actions that prohibit sex
discrimination. Pursuant to this order and review, HHS will ``revise,
suspend, or rescind such agency actions, or promulgate new agency
actions, as necessary to fully implement statutes that prohibit sex
discrimination and the policy set forth'' in section 1 of the order.
The Department is happy to keep you apprised of this work as it moves
forward.
Question. The Department of Health and Human Services (HHS) has
begun publishing facility-level COVID-19 vaccination rates for nursing
home residents and staff in response to a letter sent by bipartisan
members of the Senate Finance Committee (Chair Wyden, Ranking Member
Crapo, Senator Casey, Senator Scott) on March 24, 2021. HHS's decision
to collect and publish this data is an important transparency measure
for consumers that Senator Casey and I first called for in December
2020. However, key steps remain to make these data accessible to the
public, and provide researchers a clear picture of how the vaccine
rollout proceeded.
First, regarding the vaccination data that the Centers for Disease
Control and Prevention (CDC) has begun collecting through the National
Health Care Safety Network (NHSN) for both residents and workers, and
that the Centers for Medicare and Medicaid Services has begun
publishing in the COVID-19 Nursing Home Dataset. The dataset has become
so large that it is unwieldly for most people to handle unless they
have access to powerful computers with specialized data analysis
software. The Excel file containing the data is now more than 400
megabytes, and contains more than 200 columns and hundreds of thousands
of rows. I am concerned that in its current State, the dataset has been
rendered nearly useless for most members of the public, and is falling
short of goals laid out in the Federal Data Strategy, among which are
to ``design new data collections with the end uses and users in mind .
. . promote wide access . . . [and] diversify data access methods,'' to
ensure that cooperating agencies, stakeholders and the public can use
the data the Federal Government is collecting.
How does HHS plan to make the raw data more readily accessible than
it currently is to members of the public and policymakers who don't
have the same level of computing/analytics power that a university
researcher or think tank might have?
In doing this, how will HHS ensure that longitudinal nature of the
files will be maintained (for example, by breaking up the number of
columns by subject matter, e.g., a vaccine file; a PPE/staffing
shortages file; an infection/death file in addition to a master file)?
In March 2021, the Associated Press reported of continued problems
with the COVID-19 data site, noting that an AP a project manager with
the National Consumer Voice using the site's map had recently ``put in
a facility's name, and a popular chain restaurant came up,'' while an
AP reporter ``turned up an animal hospital, after entering the name of
a nursing home and the community it was located in.'' What steps does
HHS plan to take to improve the search capability of the nursing home
map, which is currently the only way the public can effectively find
vaccination data for individual nursing homes?
Answer. Nursing homes and long-term care facilities are the homes
for some of our most vulnerable, and we must do everything we can to
work to protect them and ensure that they are receiving high quality
health care. I have asked CMS to review the nursing home map to improve
the information available to consumers. I have also asked CMS to find
both short term improvements to the data site to make vaccination data
for nursing home residents and staff more accessible. It is a top
priority to improve transparency, evaluation, and accountability,
including increasing the available data regarding vaccinations in
nursing homes. The Department will keep you apprised of these efforts
moving forward.
Question. The bipartisan letter from Finance Committee members
called on HHS to publicly release data, including information dating
back to December 2020, that have been provided to the Federal
government by CVS and Walgreens in regards to the Long-Term Care
Partnership (LTC Partnership). The LTC Partnership data is the only
real time accounting of the rollout, and experts have told the Finance
Committee that it is critical understanding the racial, economic and
geographic equity of vaccine distribution. As the letter noted,
releasing such information retrospectively will help researchers and
policymakers analyze issues such as the speed and equity of vaccine
distribution, and the vaccine's role in reducing disease and death in
nursing homes. Moreover, the HHS has been sharing the LTC Partnership
data with States and used the data for its own public-facing research.
Given that HHS has refused to release this data publicly in
response to the Finance Committee's request, please provide me with all
facility-level vaccination data that has been transmitted to HHS by the
LTC Partnership since December 2020. Please provide these data no later
than July 15, 2021.
Answer. We would be pleased to work with your staff on your
questions related to facility-level vaccination data.
______
Question Submitted by Hon. Sherrod Brown, Hon. Benjamin L. Cardin,
and Hon. Robert P. Casey, Jr.
Question. Currently, Medicare has a statutory exclusion on Medicare
coverage of dental care and routine dental services like x-rays and
cleanings. For the two-thirds of elderly beneficiaries and individuals
with disabilities under Medicare, this means their access to care is
incomplete.
Establishing a Medicare dental benefit has been a priority of mine
for a number of years, and earlier this year I introduced legislation
again along with Senators Cardin and Casey that would create a dental
benefit under Part B to improve the health of our Medicare
beneficiaries. We also recently wrote to President Biden urging that
Medicare benefits be expanded to include dental care. I am also pleased
that the President Biden's budget supports strengthening Medicare by
improving access to dental, hearing, and vision coverage for
beneficiaries.
What are the administration's next steps to establish a dental
benefit in Medicare?
Answer. Thank you for your leadership on this important issue. Oral
health is a critical part of overall health and I look forward to
working with you on these issues. President Biden supports making
dental coverage a standard benefit in Medicare.
Question Submitted by Hon. Robert P. Casey, Jr.
Question. The COVID-19 pandemic has underscored the urgent need to
enhance quality in our Nation's nursing homes. The profound loss of
life we have experienced over the last year is a tragedy within the
broader tragedy of this pandemic. More than 183,000 residents and
workers have died of COVID-19 in nursing homes and other long-term care
facilities. Well before the pandemic, I worked alongside Senator Toomey
to shed light on cases of abuse and neglect in underperforming nursing
homes, those facilities that consistently fail to meet the standards of
care we have set forth. These nursing homes are part of what's known as
the Special Focus Facility program.
My 2019 investigation with Senator Toomey found that this subset of
nursing homes consistently fails to provide quality care, and yet not
every nursing home that needs it is receiving intervention. We have an
obligation to use every tool available to ensure that the residents who
live in these homes receive the highest standard of care, the standard
we would expect for our own loved ones.
That is why, Senator Toomey and I reintroduced our bipartisan bill,
the Nursing Home Reform Modernization Act (S. 782). This bill would
ensure that every facility that qualifies for the program receives
assistance and strong oversight.
Can you elaborate on the administration's proposal to put
additional funding towards oversight of these poor-performing nursing
homes?
Answer. The budget requests $472 million for Survey and
Certification. This level of investment will strengthen health, quality
and safety oversight for over 75,000 participating Medicare or Medicaid
provider facilities. Survey workloads and costs are increasing due to a
growing volume of facilities, serious complaints, and enforcement
activities once a deficiency is identified. Further, the COVID-19
pandemic has underscored the need for the Survey and Certification
program's oversight role for holding nursing homes and other facilities
accountable to meeting minimum infection control standard and
protecting public health for beneficiaries in these facilities from
COVID-19.
Building on lessons learned during COVID-19, the budget enables CMS
to make system improvements and technology upgrades, ensuring that
real-time information on compliance trends and quality indicators are
readily available to better target survey actions. To mitigate public
long-term health risks, CMS plans to focus further on conducting in
depth, proactive certification surveys that ensure quality issues are
detected early, avoid patient harm, and result in less severe
enforcement action over time rather than reactively responding to
complaints.
Questions Submitted by Hon. Tim Scott
Question. Secretary Becerra, 18 States (CA, DE, DC, GA, GU, HI, IL,
MD, MA, MO, NJ, OH, PA, PR, RI, SC, TX, and VI) are facing a reduction
in their TANF block grant as penalty for not meeting the Federal 90-
percent paternity establishment requirement in the child support
enforcement program. States had challenges meeting the requirement
during COVID due to limited operations and delays for DNA testing and
paternity establishment and adjudication.
Since States were unable to meet these requirements due to forces
outside of their control, will the administration commit to working
with us on a narrow fix that will hold States harmless from their
inability to meet the Paternity Establishment Percentage during the
pandemic?
Answer. The administration is willing to work with Congress on a
statutory fix that would address this penalty issue. However, HHS has
also placed on its Spring 2021 Unified Agenda a regulation that will
propose to modify the Paternity Establishment Percentage performance
requirements in child support regulations under 45 CFR part 305 to
provide relief from financial penalties to States impacted by the
COVID-19 pandemic. More about the proposed rule is available here:
https://www.reginfo.gov/public/do/eoDetails?rrid=186762.
Question. President Biden, as well as CDC officials, tout that this
budget reflects the President's commitment to close health disparities
and expands access to quality care for communities in need. In 2018, a
bill led by myself and Senator Cory Booker, the Sickle Cell Disease and
Other Heritable Blood Disorders, Research, Surveillance, Prevention,
and Treatment Act of 2018 was signed into law. Over 60 percent of
sickle cell patients are Medicaid recipients. In FY 2021, Congress
appropriated $2 million to the CDC for this program and $7.205 million
to HRSA for the Sickle Cell Disease Treatment Demonstration Program.
In this budget proposal, you only request $2 million for the CDC's
Sickle Cell Data Collection program. In last year's Budget
Justification, CDC Officials estimated that the agency would need $25
million to effectively operate the CDC's Sickle Cell Data Collection
program. Was last year's Justification taken into account when
preparing this year's budget?
Answer. CDC's Sickle Cell Data Collection (SCDC) program, has
afforded CDC the knowledge and ability to align with Public Law 115-
327. Comprehensive surveillance provides the necessary evidence for
research, policy and practice advancements to increase access to
adequate care and treatment for people with Sickle Cell Disease (SCD).
Prior to FY 2021, funds from HHS, CDC and the CDC Foundation supported
11 State-based programs to participate in SCDC, covering an estimated
36 percent of the Nation's SCD population. The $2 million FY 2021
appropriations along with other one-time, one-year funds, have helped
sustain CDC's program in these 11 States to collect and synthesize data
and produce a complete picture of SCD in their States.
Question. What policies advanced through this budget increase
access to quality care for Sickle Cell Disease patients?
Answer. The FY 2021 appropriation of $2 million in addition to
other funding sources has enabled CDC to continue funding 11 State-
based programs to participate in SCDC, which implements innovative data
linkage to produce a modern, comprehensive, and dynamic data source for
SCD surveillance. This network of State-based programs makes it
possible to identify inequities in access to care and provide a
science-based approach for directing policy initiatives for improving
care.
SCDC program findings have enabled two State-based awardees to
address access to care issues; we anticipate more reports of impact as
other States develop and establish their systems.
As SCDC continues to capture data and conduct analyses, CDC looks
forward to sharing impactful findings resulting from this population-
based, longitudinal network of State-based surveillance for SCD.
Additionally, the SCDC program is working to address health equity by
using data to inform local, State, and Federal efforts to reduce health
outcome and health resource disparities.
Question. What policies do you envision in relation to value-based
arrangements (VBAs), new models of care, or access to innovative
therapies?
Why is this not reflected in the budget?
Answer. Innovation is important to advancing goals in health care,
including for those with Sickle Cell Disease. Sickle Cell Disease (SCD)
affects approximately 100,000 Americans and continues to be a major
cause of morbidity and mortality. Given the gravity of the disease, in
2018, HHS convened the HHS Sickle Cell Disease Workgroup to address the
transition from pediatric to adult care for this population and to lead
efforts to expand data collection. In September 2020, CMS issued a data
highlight entitled ``At a Glance: Medicaid and CHIP Beneficiaries With
Sickle Cell Disease.'' This data brief found that in 2017, 41,995
people enrolled in Medicaid and CHIP were identified with SCD, most of
whom were under age 65. CMS also released a SCD indicator in the CMS
Chronic Conditions Warehouse in order to support further research. In
addition, two awardees of the 2016 4-year Pediatric Quality Measures
Program (PQMP) grants are currently testing the feasibility of
reporting the two sickle-cell measures developed through the PQMP at
the State level. The awardees are working with five State Medicaid
programs; an External Quality Review Organization; the American Academy
of Pediatrics; and the Pacific Regional Sickle Cell Collaborative, made
up of four western States. I look forward to expanding on this
important work and keeping you informed.
Question. According to the estimates published in the 2018
Physician Fee Schedule, CMS estimated that by 2020, 50,000
beneficiaries would be enrolled annually in the Medicare Diabetes
Prevention Program, at an average estimated savings of over $2,000 per
person over 3 years.
As noted in CMS's first evaluation report on the program in April
of 2021, only 2,200 people cumulatively have enrolled. One recognized
problem, which has been flagged for you before, is that CMS only
allowed in-person delivery of Diabetes Prevention Program (DPP) to
Medicare beneficiaries. You also know there are no in-person DPP sites
in many locations, including many areas in South Carolina, and there
are no virtual locations in Alabama at all.
Senate supporters of this program have also heard CMS believes it
lacks the legal authority to expand MDPP beyond in-person delivery.
Assuming that we gave you that authority right now, how fast could
CMS expand the program and how much could this save the Medicare trust
fund, 3 years after the proposed expansion took effect?
If CMS expanded the DPP program to include virtual and video
programs, would it reach more non-white beneficiaries?
Answer. Innovation is important to advancing goals in health care,
and the CMS Innovation Center is integral to the administration's
efforts to promote high-value care and encourage health-care provider
innovation, including virtual and digital health innovation. With
respect to the Medicare Diabetes Prevention Program (MDPP) expanded
model, I understand that CMS issued regulatory flexibilities in
response to the COVID-19 pandemic, including waiving the limit on
virtual sessions that can be provided by MDPP suppliers when in-person
classes are not safe or feasible. MDPP suppliers must remain prepared
to resume delivery of MDPP services in-person to start new cohorts and
to serve beneficiaries who wish to return to in-person services when
the flexibilities granted during the pandemic are no longer in effect.
Question. New data has just been released by the National Opinion
Research Center (NORC) at the University of Chicago, finding that
nearly two-thirds of assisted living facilities reported no deaths from
COVID-19 in 2020. Despite this positive data, I am concerned about
inequalities in the distribution of the Provider Relief Fund (PRF).
Assisted living providers caring for nearly 2 million elderly
individuals--the population most vulnerable to COVID--have received
less than 1 percent of all provider relief funding to date.
Assisted living providers often went above and beyond by adapting
to new building layouts, policies, rules, and changing reporting
requirements while also working to secure scarce PPE and testing
supplies. In addition, many operators increased pay, provided extra
benefits, and made operational changes to staffing in order to limit
exposure and possible COVID-19 spread. We now know that assisted living
caregivers will suffer $30 billion in losses through June 2021 due to
these efforts.
It appears the provider relief fund has a remaining balance of
about $24.5 billion. We anticipate your department will be announcing
an allocation shortly to help those providers who have yet to receive
funding for quarters three and four of 2020, as well as quarters one
and two of 2021 for expenses and revenue loss. It is critical that
these funds be allocated quickly, since it was during this time period
when COVID was at its worst. I am concerned that some provider groups
have not received to date what I consider an equitable level of
assistance for their extraordinary efforts and that is the assisted
living communities.
According to the GAO, they were allocated $627 million out of the
$175-billion fund. These senior living providers took on a very similar
role as other care providers who served on the front lines of this
pandemic such as hospitals and nursing homes, and yet they have not
being treated equitably in terms of relief.
Can you assure me that these front-line assisted living operators
will be allocated a meaningful level of funding in Phase 4?
Over half of assisted living facilities nation-wide are operating
at a loss and many say they will not be able to sustain operations for
another year if they do not receive Federal relief. How do you envision
implementing an equitable PRF distribution to these assisted living
providers who need immediate assistance?
Where are the latest HHS reports related to the status of assisted
living centers and nursing homes?
What has occurred now that the American Rescue Plan of 2021 has
been administered?
What is the take-up rate in vaccinations among this patient
population?
What collaboration efforts are ongoing between CMS and other
agencies?
Where are the current COVID relief dollars being directed to
support this sector?
Answer. Thank you for raising this important issue. I appreciate
the care being given to seniors across the Nation and recognize that
some nursing homes are still experiencing financial burdens related to
the pandemic.
As you know, to respond to the urgent needs of the nation's health
care providers in the wake of COVID-19, Congress established the
Provider Relief Fund (PRF)--an investment to stabilize the U.S. health
care system facing unprecedented financial losses. In addition,
Congress also appropriated an additional $8.5 billion for providers and
suppliers of rural Medicare, Medicaid, and Children's Health Insurance
Program (CHIP) services. HHS appreciates the support of Congress,
State, and local governments; health-care providers; and countless
others in this unprecedented coalition to defeat this virus.
HHS is committed to distributing PRF payments as quickly and
equitably as possible while utilizing effective safeguards to protect
taxpayer dollars. In order to distribute PRF funding as rapidly as
possible at the beginning of the pandemic, HHS began by making
automatic payments to providers who billed Medicare on a fee-for-
service basis. In June 2020, HHS began making payments to Medicaid and
CHIP providers, dentists, and assisted living facilities as well. In
October 2020, HHS opened Phase 3 of the PRF to all eligible providers
based on actual lost revenues and incurred expenses attributable to
coronavirus, as well as to behavioral health providers who had not been
eligible previously.
With a number of facilities being particularly susceptible to lost
revenues or increased health care expenses as a result of the pandemic,
HHS has obligated approximately $13 billion in PRF payments to long-
term care facilities and senior housing, including assisted living
facilities, custodial care facilities, nursing homes, and skilled
nursing facilities. These payments cover lost revenues and increased
costs to maintain safe environments for residents and staff.
To promote transparency in the PRF program, HHS also plans to
release detailed information about the methodology utilized to
calculate Phase 3 payments. Providers who believed their Phase 3
payment was not calculated correctly according to the methodology will
be given an opportunity to request a reconsideration. All PRF Phase 3
reconsiderations are subject to the availability of funds.
HHS appreciates the care being given to communities across the
nation and recognizes that, in doing so, some providers still have
difficulties meeting their financial responsibilities. As HHS continues
to distribute funds, your feedback informs our ability to administer
the PRF in a manner that bolsters the health care system and helps
providers experiencing COVID-related financial hardships during this
crisis.
With regard to vaccinations, CMS is seeking comment on
opportunities to require Medicare and Medicaid certified facilities to
educate and offer the COVID-19 vaccine, with the goal of helping
vaccine uptake. Unlike skilled nursing facilities or long-term
facilities, CMS does not certify assisted living facilities. As part of
CMS's commitment to protecting nursing home residents, Medicare and
Medicaid certified facilities are now required to report vaccinations
of residents and staff. CMS has posted resident and staff vaccination
rates for Medicare and Medicaid certified facilities on the CMS COVID-
19 Nursing Home Data webpage.
Question. Medicare Advantage (MA) represents a market-oriented,
competitive, more affordable, and more comprehensive alternative to
fee-for-service for seniors. Average monthly MA premiums declined
substantially from 2010 to 2019, falling from $44 to $29. Both in South
Carolina and at the national level, Medicare Advantage (MA) enrollment
has increased dramatically in recent years, rising from 12 percent of
Medicare beneficiaries in South Carolina in 2009 to 27 percent in 2019,
and from 23 percent of total beneficiaries nationally in 2009 to 34
percent in 2019.
In the FY 2022 HHS budget, you propose payment reductions for MA
plans and propose using offsets similar to rules from the Obama
administration. Could you please elaborate and expand on why this
payment reduction would help the Medicare Advantage program?
Answer. The administration supports efforts to ensure that Medicare
Advantage is serving the needs of beneficiaries with affordable and
high-quality care, particularly as it continues to serve more
Americans. In CY 2022, Medicare Advantage enrollment will total about
29.2 million beneficiaries, or 49.1 percent of all Medicare
beneficiaries who have both Parts A and B. Between 2012 and 2021,
private plan enrollment grew by 13.8 million or 102 percent, compared
to growth in the overall Medicare population of 25 percent for the same
period. CMS data confirm 99 percent of Medicare beneficiaries have
access to at least one Medicare Advantage plan in CY 2021.
Question. Outdated coverage restrictions have long inhibited access
to telehealth services for many of the nation's roughly 61 million
Medicare beneficiaries. For years, rigid rules around patient location
(geographic and site of service), eligible services and provider sites,
and other components of care have created substantial barriers to
telehealth utilization. In February 2020, for instance, just prior to
the COVID-19 public health emergency (PHE), only 0.1 percent of
Medicare fee-for-service (FFS) primary care visits were delivered via
telehealth. In any given week before the PHE, an average of just 14,000
Medicare beneficiaries received a telehealth service.
While these Medicare access gaps predated the pandemic, the spread
of COVID-19 highlighted the urgency of updating telehealth coverage
rules, prompting Congress to provide authority for pivotal emergency
waivers designed to ensure safe access to care for seniors and other
vulnerable populations. As the pandemic raged, Medicare beneficiaries
turned to telehealth services to minimize viral exposure risk and
receive medically necessary care in safe and accessible settings. In
April 2020, more than two-fifths (43.5 percent) of Medicare FFS primary
care visits were provided through telehealth, and from mid-March
through early July of that year, more than 10.1 million beneficiaries
accessed telehealth services.
With all of this information in mind, as well as the claim from
this administration that their priorities reflect closing gaps to high
quality care, why did you not include any telehealth priorities in the
proposed budget?
Answer. Telehealth is an important tool to address health equity
and improve access to health care. Health care should be accessible, no
matter where you live. HHS continues to examine the telehealth
flexibilities developed for the current public health emergency and
determine how we can build on this work to improve health equity and
improve access to health care. I look forward to working with Congress
to determine which flexibilities can be continued administratively and
what may need to be done through legislation.
______
Questions Submitted by Hon. John Barrasso
Question. As we previously discussed, rural hospitals continue
facing unique challenges. Ensuring hospitals in Wyoming and the rest of
rural America have the recourses they need is a high personal priority
of mine.
In particular, I've heard from some hospitals in Wyoming that they
are concerned they will not be able to meet the June 30th deadline to
utilize funding provided by the Provider Relief Fund.
With the June 30th deadline fast approaching, can you please
provide additional information about the types of flexibilities you
support and when you will communicate information to providers?
Answer. Please note that PRF recipients may use payments for
eligible expenses or lost revenues incurred prior to receipt of those
payments (i.e., pre-award costs) so long as the funds are to prevent,
prepare for, and respond to coronavirus. It is the obligation (or
incurred) date that determines whether the expense is an allowable
cost, not the date of possession. If the purchase occurred within the
period of availability, but the item was received after the period of
availability, it would still be considered an allowable cost. The
provider will need to maintain adequate supporting documentation to
show that the expense is attributable to coronavirus and was incurred
within the period of availability. Providers must retain supporting
documentation for 3 years.
HHS has also hosted webinars to provide technical assistance to
providers. The recordings are made available online at https://
www.hhs.gov/coronavirus/cares-act-provider-relief-fund/reporting-
auditing/index.html. We also encourage providers to contact the
provider support line--HHS will now provide second tier technical
assistance for providers and will communicate directly with them to
walk through their questions. The number is (866) 569-3522; for TTY
dial 711. Hours of operation are 7 a.m. to 10 p.m. Central Time, Monday
through Friday.
Question. The administration's budget proposal includes provisions
related to workforce programs. From our previous discussions, you know
my passion for addressing the shortages of health care providers in
rural communities.
Previously, I helped introduce both the Rural Physician Workforce
Production Act and Physician Shortage GME Cap Flex Act. These are both
bipartisan proposals to improve graduate medical education. This is
vital for rural States, which face the greatest shortages of
physicians.
Can you discuss the specific proposals in your budget related to
health-care workforce development?
Answer. HHS is committed to strengthening the health workforce and
connecting skilled providers with communities in need. The FY 2022
President's budget includes a number of proposals related to health-
care workforce development. For example, the budget requests an
increase of $47.3 million for the National Health Service Corps
programs to improve access to quality primary care, dental, and
behavioral health in underserved urban, rural, and tribal areas. In
addition, the American Rescue Plan (ARP) Act provided approximately
$330 million for Teaching Health Center Graduate Medical Education.
These funds will support the expansion of the primary care physician
and dental workforce in underserved communities through community-based
primary care residency programs in family medicine, internal medicine,
pediatrics, internal medicine-pediatrics, psychiatry, obstetrics and
gynecology, generally dentistry, pediatric dentistry, or geriatrics.
Teaching health centers specifically have been shown to attract
residents from rural or disadvantaged backgrounds who are more inclined
to practice in underserved areas than those from urban and economically
advantaged backgrounds. Most recently, using ARP Act funds, HHS
established several new health workforce programs, including two
programs supporting training activities that aim to reduce burnout and
address mental health problems experienced by health care workers. HHS
continues to develop the health care workforce in rural areas through
the Primary Care Training and Enhancement: Physician Assistant Rural
Training Program, among other programs. This particular program
increases the number of primary care physician assistants, particularly
in rural and underserved settings, and improves primary care training
in order to strengthen access to and delivery of primary care services
nationally.
Question. Will you work with Congress on proposals to reform
Medicare's Graduate Medical Education program?
Answer. Encouraging more health professionals to work in rural
hospitals and underserved areas, and the need to retain and train high-
quality physicians to help address access to health care in these
communities, is critically important. HHS is working hard to implement
the provisions of the Consolidated Appropriations Act, 2021 that
increase medical residency positions in hospitals in rural and
underserved communities to address workforce shortages. In the FY 2022
Inpatient Prospective Payment System proposed rule released in April,
CMS sought comments on implementation of these provisions and those
comments are under review.
Question. Medicare is a vital program for seniors in Wyoming and
across our Nation. As a doctor, I know the importance of protecting
Medicare for our current seniors and future generations.
Right now, according to the Medicare trustees, the trust fund will
run out of reserves by 2026. Under current law, this means the program
will not be able to pay out full benefits. This means within 5 years
seniors may not be able to get the care they need.
I am concerned the administration does not recognize the dire
situation facing the Medicare trust fund.
Do you believe we must address the solvency of the Medicare trust
fund before making any other substantial changes to the program?
Answer. Americans have paid for their Medicare. It has been a
lifeline and continues to be for 63 million people today. This is why I
want to work with you and the Congress to protect Medicare and find
bipartisan solutions to extend the life of the Medicare hospital
insurance trust fund. That's why the President's FY 2022 budget
includes the President's American Families Plan Medicare tax reforms
that would increase revenues to Medicare and extend the solvency of the
trust fund by roughly 11 years. We need to get this right to make sure
Medicare is strong for current and future beneficiaries.
Question. I help lead the bipartisan Comprehensive Care Caucus with
Senators Rosen, Baldwin, and Fischer. We work in a bipartisan manner to
improve hospice and palliative care.
We all support giving patients the option to receive the same
quality care, in various settings, including in their communities and
homes or wherever they may call home.
Can you discuss your priorities regarding hospice and palliative
care?
Answer. Ensuring that patient choices are respected, including the
ability to receive palliative/hospice care at home, is of utmost
importance. At the same time, in providing palliative/hospice care at
home, improving the safety and quality of care for patients is
critical. Across CMS programs, the agency is working to address the
significant and persistent inequities in health outcomes in the United
States, including within hospice care. For example, earlier this year,
CMS released a request for information to gather feedback from the
hospice industry on ways to enhance work to close the health equity gap
in the hospice quality reporting program. I look forward to working
with you to ensure that patients receiving palliative/hospice care have
access to high-quality care.
Question. My wife Bobbi and I are passionate about improving access
to mental health services. This pandemic has clearly impacted the
mental, as well as the physical health of our Nation.
For people living in rural America, getting help from a mental
health provider was challenging before the pandemic. This is why
Senator Stabenow and I have long supported professional counselors and
marriage and family therapists participating in Medicare. We believe
that increasing the number of mental health providers able to care for
our Nation's seniors is an important priority.
Next week, this committee will be holding our second hearing on
mental health. Many members of this committee are working in a
bipartisan manner to improve mental health.
Can you discuss your budgetary priorities regarding mental health?
Can you commit to working with me to expand the number of mental
health professionals able to care for Medicare patients?
Answer. This administration shares your commitment to making
quality mental health services available to all Americans, including
our Nations' seniors. Americans are experiencing increased mental
health challenges and greater barriers to receiving necessary
behavioral health care. The FY 2022 budget provides $2.9 billion for
SAMHSA's mental health activities, an increase of $1.1 billion over FY
2021 enacted. These investments will develop the behavioral health
infrastructure, expand suicide prevention activities, support the
success of 988 crisis services, address children's mental health, and
increase community-based mental health programs that provide services
to the nation's most vulnerable populations. I am committed to working
with you on increasing access to mental health services for our
Medicare beneficiaries.
Question. There is widespread agreement the advancements in
telehealth during COVID-19 have been critical for patients. Congress is
committed to working with you to make this a permanent part of health-
care delivery.
In Wyoming, most of our providers are part of smaller hospitals and
practices. We need to make sure government regulation is not making it
more difficult for these providers to serve their patients.
As you work with us to ensure access to telehealth, can you commit
to working to address needs of rural communities and small physician
practices?
Answer. Telehealth is an important tool to improve health equity
and improve access to health care. Health care should be accessible, no
matter where you live. HHS continues to examine the telehealth
flexibilities developed for the current public health emergency and
determine how we can build on this work to improve health equity and
improve access to health care. Through the course of the COVID-19
pandemic, the delivery of health care through telehealth technologies
greatly expanded. Telehealth technologies became an effective modality
for the delivery of mental and behavioral care, especially for those
seeking care in conjunction with substance use disorder. We have also
seen rural patients avoid long travel times and increased risk of
exposure to the coronavirus when telehealth technologies are used to
provide for care and coordination using a team-based approach care that
links the mental and behavioral health services to primary care. I look
forward to working with Congress to determine which flexibilities can
be continued administratively and what may need to be done through
legislation.
______
Questions Submitted by Hon. Todd Young
Question. The Federal contractors that run the organ donation
system--Organ Procurement Organizations (OPOs)--are massively failing
patients across the country. I have been championing oversight and
reform for OPOs for a few years now, including via an active,
bipartisan investigation from Senate Finance Committee into OPOs and
their oversight body, the United Network for Organ Sharing (UNOS). HHS
finalized reforms in November to ensure that OPOs will finally be held
accountable to objective data for the first time in 40 years, and that
failing OPOs will actually lose their contracts. This is projected to
save more than 7,000 lives every year as well as more than $1 billion
annually to Medicare in avoided dialysis costs through increased kidney
transplants.
The new regulation, however, currently does not allow HHS to
decertify a failing OPO until 2026. What actions will you take to
accelerate that timeline?
Answer. Thank you for your work through the years on improving
oversight and reform of Organ Procurement Organizations. We share your
desire to drive performance improvements in this area as quickly as
possible. While decertification based on the new performance measures
will not occur until 2026, the performance of each OPO will be assessed
annually. Each OPO will have an opportunity to improve their
performance and receive information about its performance following
those improvements. By identifying the performance of OPOs annually,
poor performing OPOs can appropriately change and adopt effective
practices that improve their performance in donation and make more
organs available for transplantation. OPOs identified as being lower
performing at the final assessment period in of the agreement cycle
would potentially be decertified or have their donation service area
open for competition in 2026. We anticipate OPO performance will
continue to improve when incentivized by more transparent and
accountable measures provided under the final rule.
Question. What oversight is HHS providing over UNOS to ensure
they're living up to the requirements set out in statute?
Answer. Thank you for your continued interest in organ procurement
and transplantation. UNOS serves as the HRSA contractor for the Organ
Procurement and Transplantation Network (OPTN). Organ Procurement
Organizations (OPOs) are required by statute to be members of the OPTN,
and there are numerous OPTN policies related to OPOs and their
performance. Currently, HRSA provides oversight of UNOS through
requirements of the Federal Acquisition Regulation (FAR) and specific
performance-based language contained in its contract. HHS
representatives meet weekly, or more often as needed, with the OPTN
contractor to receive updates on all aspects of the OPTN contract. In
addition, the OPTN contractor coordinates a separate weekly meeting
between HHS and the volunteer leadership of the OPTN Membership and
Professional Standards Committee, which is the OPTN committee that
oversees compliance, performance, and patient safety monitoring of
member organizations. Information obtained from the OPTN Membership and
Professional Standards Committee and the OPTN contractor is shared with
CMS per an information sharing agreement.
Question. Would you be willing to work with us on oversight of
these organizations and UNOS so we can hold these organizations
accountable?
Answer. Yes.
Question. I have worked with Senator Smith to improve public health
preparedness by ensuring Federal agencies advance a ``One Health''
approach--the idea that human and animal health are linked, and that
they should be studied together--to prevent and respond to disease
outbreaks. The COVID-19 pandemic illustrates how we must focus our
efforts on better understanding the connection between animal and human
health.
Our legislation, the Advancing Emergency Preparedness Through One
Health Act, would improve coordination among those studying animal and
human health by requiring the Department of Health and Human Services
(HHS), the Agriculture Department (USDA), and the Department of
Interior (Interior) to adopt a One Health framework with other
agencies.
What plans do you have in place to better coordinate with other
appropriate departments or agencies to prepare for future zoonotic
disease outbreaks?
Answer. In the House Appropriations Committee report that
accompanied the most recent appropriations bill, the committee directed
CDC to develop a national One Health framework to combat the threat of
zoonotic diseases and advance emergency preparedness. The committee
also directed CDC to work with the Department of Agriculture and
Department of Interior to develop a One Health coordination mechanism
at the Federal level to strengthen One Health collaboration related to
prevention, detection, control, and response for the prioritized
zoonotic diseases and related One Health work across the Federal
Government.
The CDC One Health Office is coordinating with a core group of
representatives from CDC, USDA, and DOI to draft a national One Health
framework that describes a common vision and goals in the One Health
space to prevent, detect, and respond to shared health threats at the
human-animal environment interface. The draft framework will be shared
with key Federal partners actively working in the human, animal, and
environmental health sectors for feedback.
Additionally, CDC is collaborating with the Federal Bureau of
Investigation and the United States Army Medical Research Institute of
Infectious Diseases (USAMRIID) to establish two new interagency
agreements that will support development, evaluation, and deployment of
novel diagnostic assays for biothreat agents and emerging infectious
diseases in both environmental samples and clinical specimens. Another
key partner is the Department of Homeland Security which through their
Countering Weapons of Mass Destruction Office have a Food, Agriculture
and Veterinary Defense Program, as well as the National Biosurveillance
Integration Center which monitors human, plant, animal, and food
security threats across the globe. Lastly HHS is a participant in the
interagency Defense Against Agroterrorism Working Group chaired by USDA
and DHS.
Question. The Social Impact Partnership to Pay for Results Act
(SIPPRA), bipartisan legislation I wrote and led with Senator Bennet
(and which went through your old House committee, Ways and Means), was
enacted in early 2018. It created a new Federal outcomes fund at the
Department of Treasury, with additional coordination and supervision
provided by an interagency Federal council that includes HHS.
Applications were due over 2 years ago (May 2019). State and local
jurisdictions across the country applied for SIPPRA funds, and after
thoroughly reviewing these applications, a bipartisan commission
recommended eight finalists for outcomes-based funding awards (October
2019).
Two of these projects, including one from my home State of Indiana,
and an additional project in Spartanburg, SC, would fund home visiting
services to improve health, education, and wellness outcomes for
infants, young children, and their families.
Yet despite a statutory deadline of late November 2019 for the
Federal Government to announce its first round of awards, as of this
month, only one award out of the eight finalists has been announced.
The Indiana project had to exit the process due to this delay. The
others, including the South Carolina project, have been waiting for an
answer now for over 2 years.
My understanding is the South Carolina project has now been
transferred to the Health Resources and Services Administration (HRSA)
within HHS, giving your department the primary lead in getting the
groundbreaking outcomes-driven project out the door.
What steps will you and your team take to avoid further unnecessary
delays, and ensure that this outcomes fund lives up to the full
potential envisioned in the bipartisan legislation I and others worked
together to enact?
Answer. As you know, Congress appropriated $100 million for the
SIPPRA program to implement ``Social Impact Partnership Demonstration
Projects'' and feasibility studies to prepare for those projects.
Through the Social Impact Partnership Demonstration Projects, the
Federal Government will pay for a project only if predetermined project
outcomes have been met and validated by an independent evaluator. The
SIPPRA program is administered by the Department of the Treasury, in
partnership with OMB. The Federal Interagency Council on Social Impact
Partnerships, chaired by OMB and made up of 10 Federal agencies
including HHS, plays a key consultative role in the SIPPRA review and
award process. The HHS representative to this Interagency Council is
the Assistant Secretary for Planning and Evaluation (ASPE).
Due to existing expertise in evidence-based home visiting, HRSA
participated in the review of two SIPPRA applications that proposed to
use evidence-based home visiting interventions in their projects in the
summer of 2019. The Interagency Council certified both projects in June
2020. At this time, Treasury and the Spartanburg, SC project team
continue discussions regarding the project and no final award or
transfer of project to HRSA has occurred. HHS continues to consult
actively with Treasury on SIPPRA implementation.
Question. I have serious concerns about the administration's recent
reversals of pro-life policies. These actions go against the principles
held by most Americans--and certainly most of my constituents in
Indiana.
Most recently, I have heard concerns from many of my constituents
regarding the elimination of the Hyde Amendment in the President's FY
2022 budget proposal. This provision protects the many Americans
opposed to abortion from being forced to pay for it using their
taxpayer dollars. It's a protection that has had bipartisan agreement
for decades--making its elimination now all the more alarming.
In light of the Hyde Amendment's elimination in the President's
budget proposal and other recent reversals of pro-life policies, do you
intend to use HHS's budget to advocate for policies that promote
abortion?
Answer. The Hyde Amendment disproportionately impacts the growing
number of low-income women of color who are enrolled in Medicaid, and
is a barrier to expanding access to health care. That is why the
President's first budget calls for Congress to remove the restriction
from government spending bills.
The Department of Health and Human Services (HHS) implements the
laws that Congress passes.
______
Questions Submitted by Hon. Maggie Hassan
Question. As you know, the opioid epidemic has devastated
communities and families across the country. Since 2017, I have worked
with my colleagues to secure funding for State Opioid Response grants,
including more than $86 million for New Hampshire. This funding has
enabled States to expand access to life-saving treatment and services
for those struggling with substance use disorder.
But I am concerned that hard-won progress may be in jeopardy. As we
discussed at the hearing, some of the hardest-hit States--including New
Hampshire--are at risk of a dramatic cut in State Opioid Response grant
levels under the program's current funding formula.
Does the Substance Abuse and Mental Health Services Administration
(SAMHSA) have the authority to make adjustments or modifications to the
funding formula currently used to determine State grant levels under
the State Opioid Response grant program?
Answer. HHS, through SAMHSA, has the discretion to make certain
adjustments and modifications to the funding formula currently used to
determine State grant levels under the State Opioid Response grant
program. I will work to ensure that our hardest-hit States can maintain
and build upon the progress they've made.
Question. Does SAMHSA have the statutory authority to change the
number of States that qualify for the up to 15-percent set-aside for
States with the highest age-adjusted drug overdose mortality rate based
on Centers for Disease Control and Prevention (CDC) data?
Answer. Yes. HHS, through SAMHSA, has the discretion to change the
number of States that qualify for the up to 15-percent set-aside.
Question. Does SAMSHA have the statutory authority to ensure that
the formula prevents a significant cliff in funding between States with
similar drug overdose mortality rates?
Answer. There is flexibility in the statute that could allow HHS,
through SAMHSA, to help avoid a significant funding cliff between
States with similar mortality rates consistent with the FY 2020 L-HHS
Report, which ``urges the Assistant Secretary to ensure the formula
avoids a significant cliff between States with similar mortality
rates.''
Question. Does SAMHSA have the statutory authority to prevent a
funding cliff in certain States when compared to prior year
allocations?
Answer. The statutory formula is based on mortality rates and
national survey results related to drug use and drug-related deaths.
The report language I referenced previously requests the Assistant
Secretary to avoid significant cliffs between States with similar
mortality rates and there is flexibility in the statute to help
accomplish this.
Question. Will you ensure that the funding formula for State Opioid
Response grants does not cause States to experience funding cliffs
beginning in fiscal year 2022?
Answer. The report language I referenced previously requests the
Assistant Secretary to avoid significant cliffs between States with
similar mortality rates and there is flexibility in the statue for
doing so.
______
Questions Submitted by Hon. Steve Daines
Question. Your proposed budget eliminates the longstanding Hyde
Amendment. This amendment prohibits funding under the Labor/HHS
appropriations bill for elective abortions and health benefits coverage
that includes coverage of elective abortions.
Please provide an estimate of how many abortions would receive
Federal funding, and what amounts of Federal expenditures and State
expenditures, respectively, would be incurred with respect to abortions
as a consequence of eliminating the Hyde Amendment, as your budget
proposes, for each fiscal year over 10 years.
Please disaggregate your estimates (1) by gestational age in weeks,
(2) by State, and (3) by Federal program (i.e., Medicaid, Medicare
disability, and any other applicable programs funded under the Labor/
HHS appropriations bill).
Answer. The FY 2022 President's budget carries out the President's
stated position regarding the Hyde Amendment. The Department follows
the current law when it comes to the use of Federal resources,
including the Hyde Amendment that Congress first passed in 1976 as a
part of the Department's appropriations.
Question. In Gonzales v. Carhart, 550 U.S. 124 (2007), the U.S.
Supreme Court upheld the Partial-Birth Abortion Ban Act of 2003 (18
U.S.C. Sec. 1531), the Federal ban on committing partial-birth
abortions.
Do you agree with the Supreme Court's decision to uphold the
Federal ban on partial-birth abortions?
Will you abide by this Supreme Court decision and enforce the
Federal law banning partial-birth abortion?
Answer. As HHS Secretary, my role is to implement the law. As I
have previously stated during confirmation hearings, the Department
will follow all applicable laws as they relate to abortion and any
other issue.
______
Questions Submitted by Hon. Rob Portman
Question. Last March, the Drug Enforcement Agency (DEA) and the
Centers for Medicare and Medicaid Service (CMS) issued key waivers
allowing providers to prescribe medication-assisted treatment (MAT) and
other necessary drugs via audio-only telehealth following an audio-
visual visit, and to bill Medicare for audio-only telehealth services
for substance use disorder. I've heard from behavioral health providers
in Ohio that these waivers have both helped to maintain access to care
safely at home as well as increased access to care for those that
didn't otherwise have access to in-person treatment. Therefore, Senator
Whitehouse and I introduced the Telehealth Response for E-prescribing
Addiction Therapy Services (TREATS) Act last summer to make these key
waivers permanent and increase overall access to MAT. Without action
from Congress, these important waivers will expire at the end of the
public health emergency, cutting off access to vital treatment at a
time when the country is once again battling a surge in overdose
deaths.
Will you commit to working with Congress before ending the
emergency so that we can pass key legislation, like the TREATS Act?
Answer. HHS is dedicated to the equitable provision of evidence-
based treatment to all patients. For those unable to attend treatment
or counseling sessions in person, telemedicine--whether it be delivered
via audiovisual platforms or an audio-only device--represents an
opportunity to provide or to continue services. In a recent publication
entitled ``Telehealth for the Treatment of Serious Mental Illness and
Substance Use Disorders,'' SAMHSA evaluated telehealth delivery
platforms in detail. The publication supports the use of these
services, as they: allow those in recovery to attend treatment or
counseling with minimal disruption to their daily activities; provide a
means for those living in rural or remote areas to expediently access
care; allow expansion of services beyond treatment facilities; improve
the
provider-client relationship through flexible scheduling; facilitate
care coordination activities; maximize workforce productivity, and
reduce burnout; and reduce service delivery costs by allowing remote
work and care provision.
Telehealth is an important tool to improve health equity and
improve access to health care. Health care should be accessible, no
matter where you live. HHS continues to examine the telehealth
flexibilities developed for the current public health emergency and
determine how we can build on this work to improve health equity and
improve access to health care. I look forward to working with Congress
to determine which flexibilities can be continued administratively and
what may need to be done through legislation.
Question. Additionally, we've been working to get technical
assistance for our bill from the DEA and SAMHSA but have been slowed
down over concerns with potential diversion of MAT under our bill. Can
you commit to working with us to get these concerns resolved in a
timely manner?
Answer. Expanding access to treatment for individuals with opioid
use disorder is a priority for the Biden-Harris administration, and I
commit to working with Congress to expediently address concerns
regarding potential diversion and other public safety issues.
Question. I'm excited to see the budget request include historic
levels of funding to help end the opioid epidemic. I have been
incredibly troubled by the once again rising trend in drug overdoses
we've observed over the past year--overdose deaths have risen by 29
percent nationwide and 24 percent within Ohio. It's all the more
heartbreaking because just a few years ago, we were making the first
real progress in turning the tide of this epidemic in decades, with
nationwide drug overdoses declining in 2018 for the first time since
1990. As such, this funding is more important than ever to end this
epidemic once and for all. I recently introduced my bipartisan
Comprehensive Addiction and Recovery Act (CARA) 3.0 legislation, which
invests additional funding into original CARA programs that are
providing evidence-based prevention, treatment, and recovery programs
to combat addiction. In fiscal year 2021 alone, CARA programs are
providing $782 million to communities to support these services. It is
more important than ever that our communities are well-equipped to
address substance use issues and so I appreciate your prioritization of
this issue.
I was pleased to see a new 10-percent set-aside included in the
Substance Abuse Prevention and Treatment Block Grant to direct funds to
States for recovery support services, which can include recovery
housing. Research on recovery support services, specifically, recovery
housing, consistently finds positive outcomes that meet or exceed those
of acute and medical model services. Recovery housing is an evidence-
based service that addresses both social determinants of health as well
as the chronic nature of substance use disorders. My CARA 3.0
legislation directs SAMHSA to develop guidelines that States can use to
promote the availability of high quality, evidence-based recovery
housing, as well as funding for States to implement the SAMHSA-
developed guidelines and promote recovery housing as a treatment model.
Can you elaborate as to how SAMHSA plans to implement this proposed
10-
percent set-aside and ensure local communities utilize this funding to
expand access to high-quality recovery housing programs?
Answer. HHS is pleased and excited to have the opportunity to build
upon SAMHSA's historic commitment to recovery support services,
including high-quality recovery housing programs, through our current
agency-wide planning and activities related to the robust
implementation of the proposed new 10-percent set-aside for the
Substance Abuse Prevention and Treatment Block Grant (SABG) to direct
funds to States for recovery support services.
SAMHSA will be working closely with recovery support services
partners, stakeholder groups, and technical assistance experts in
promoting and advancing high-quality, evidence-based recovery support
services, including those organizations that are at the forefront of
promoting quality standards and certifications for recovery housing
efforts. SAMHSA's efforts will include the comprehensive
identification, support, and promotion of evidence-based research,
literature, educational materials, training, and technical assistance
regarding recovery support services.
Question. I'd like to thank you for your support for the Money
Follows the Person program in the budget request. As you know, I've
supported this program since its inception and have fought year after
year to extend the program. In fact, I think its past time we make this
program permanent and so I am currently working with Senator Cantwell
on a bill to do just that. The lack of predictability that comes with a
grant program can be tough for States in terms of planning for the
future. This program works and its past time to make it permanent.
This program is a win-win--it provides better care to patients in a
more comfortable setting at home and it saves money. Since its
inception in 2007, the program has transition over 100,000 individuals
from an institutional setting to the community. Furthermore, according
to a 2017 Report to Congress from HHS, average per-beneficiary per-
month costs decreased from $13,469 per month to $9,456 per month when
beneficiaries used the MFP program to transition into home and
community-based care. The report also found that the program has
succeeded in lowering hospital readmission rates among those
beneficiaries that transition out of nursing home care.
While all of these findings are compelling in terms of the benefits
of the MFP program, one of our longstanding challenges in working on
this program from a legislative standpoint is that the Congressional
Budget Office is skeptical of the cost savings I just outlined.
Will you work with CBO to come up with a more realistic cost
assessment of expanding this program?
Answer. Thank you for your leadership on this important issue. The
Money Follows the Person (MFP) demonstration gives beneficiaries more
options for their care and allows them to choose to receive care in the
community, rather than institutions. This demonstration has shown
promising results, including improving participant quality of life and
lowering the cost of care. The administration supports a permanent
extension of MFP.
Question. We all saw the conditions at the convention centers and
other facilities used during the surge of migrants across the border.
What is the Biden administration doing to create better medium-term
solutions for the next surge?
Answer. The HHS Office of Refugee Resettlement (ORR) is utilizing
all available options to safely care for unaccompanied children,
including short-, medium-, and long-term solutions. In the short term,
ORR is working to ensure unaccompanied children do not spend more time
in border patrol facilities than necessary by: (1) safely increasing
capacity in its State-licensed network; (2) safely reducing the time it
takes to place unaccompanied children with their vetted sponsors; (3)
expanding influx care facilities that can meet the same standards of
care used in ORR's State-licensed network; and (4) utilizing temporary
Emergency Intake Sites that provide safe and appropriate care for
children when necessary, for short-term placements.
Over the medium to long term, ORR will continue to build back its
licensed capacity network through different avenues, working with
existing and new providers. ORR is also exploring a flexible bed
capacity model that will allow beds that are deactivated and held on
reserve during periods of low occupancy to be quickly reactivated
during surges of unaccompanied minors at the border.
Question. Recent data from the Centers for Disease Control and
Prevention (CDC) indicate that drug overdose deaths skyrocketed during
the COVID-19 crisis, demonstrating both the tremendous toll of this
epidemic within the pandemic and the importance of access to effective
opioid treatment services. Successful treatment relies in part on
clinical urine drug testing, an unbiased laboratory test, which is used
in identification of addiction, diagnosis, treatment, and recovery. In
particular, definitive urine drug testing provides the sensitivity and
specificity necessary to enhance substance use disorder (SUD)
treatment. In 2019, the Centers for Medicare and Medicaid Services
(CMS) finalized regulations that included definitive drug testing in
the new bundled payment for opioid treatment services. While the goal
of this policy is to expand access to treatment services, this fixed
payment method actually has prompted many treatment providers to forgo
drug testing. Providers rely on these timely, accurate, and clinically
actionable information and without the ability to utilize impartial
testing many patients do not have access to successful treatment
options.
Can you please speak to the importance of definitive urine drug
testing in SUD treatment and explain how your department will support
access to these services?
Answer. Urine drug screening is an important tool for SUD
treatment, as it speaks to the patient's treatment progress. However,
it is only one aspect of treatment and patient engagement for
treatment. It is also important to note that the majority of Opioid
Treatment Programs (OTP), housed in SAMHSA, undertake drug screening.
Drug screens are fast, inexpensive and provide timely information for
patient progress under their treatment program.
How is HHS encouraging providers to utilize a neutral based testing
solution to ensure both Medicare and Medicaid beneficiaries have access
to treatments, as well as receiving real-time reported data to help
combat this epidemic?
Answer. Thank you for bringing this issue to my attention. Under
SAMHSA certification standards, opioid treatment programs (OTPs) are
required to provide adequate testing or analysis for drugs of abuse,
including at least eight random drug use tests per year, per patient in
maintenance treatment in accordance with generally accepted clinical
practice. These drug use tests are used for diagnosing, monitoring and
evaluating progress in treatment. Medicare began covering opioid use
disorder treatment services furnished by OTPs on January 1, 2020. As
required by law, OTPs are paid a bundled payment for opioid use
disorder treatment services including toxicology testing. To determine
this weekly bundled payment, CMS included pricing for both presumptive
and definitive testing. CMS is monitoring beneficiaries' access to
medically necessary definitive testing under the bundled payment for
opioid use disorder treatment services. If CMS finds there are any
issues with beneficiary access, CMS may consider making changes to how
these tests are paid.
Regarding Medicaid, States work directly with providers, including
those delivering needed SUD services to Medicaid beneficiaries. There
also are various Federal authorities and CMS-led initiatives available
to assist States in their ongoing efforts to respond to the opioid
crisis. For example, in November 2017, CMS announced a new opportunity
under the authority of section 1115(a) of the Social Security Act for
States to demonstrate and test flexibilities to improve the continuum
of care for beneficiaries with substance use disorders including opioid
use disorder, as well address particular challenges raised by the
opioid epidemic in their State. In addition, CMS created similar
flexibility to test more comprehensive approaches to care for
beneficiaries with serious mental illness (SMI) or serious emotional
disturbance (SED). To date, 27 States and the District of Columbia have
an ongoing SUD and/or SMI/SED section 1115(a) demonstration.
______
Questions Submitted by Hon. Mark R. Warner
Question. One issue that has significantly impacted Virginia and
that I have been working to address is the significant increase of
black lung in our coal miners. Black lung disease is a debilitating,
potentially fatal disease caused by long-term exposure to coal dust.
If black lung is caught early, steps can be taken to help prevent
it from progressing to the most serious forms of the disease.
Currently, the Centers for Disease Control's National Institute of
Occupational Safety and Health offers free health screenings to miners
and the accessibility and confidentiality of these screenings enable
miners to get early screening for the disease.
Unfortunately, there are only two NIOSH Mobile Testing Units in the
Appalachian region. One of these units is not currently operating and
one unit is expected to be defunct within a couple of years.
This year, I am requesting that the Senate Appropriations Committee
provide at least $2 million to NIOSH for a new mobile screening unit
and to better maintain existing units. I am hopeful this request will
be granted, but will you also commit to working with me to ensure that
these units remain functional?
Answer. HHS and CDC are strongly committed to maintaining mobile
outreach services to bring respiratory health screening to coal miners.
The Coal Workers' Health Surveillance Program (CWHSP), operated by CDC,
provides respiratory health screening to coal miners in part through
mobile outreach. Mobile outreach has played an important role in
bringing screening consistent with requirements of the Federal Mine
Safety and Health Act and Federal regulations at 42 CFR part 37 to
geographical areas with low participation rates and areas at high risk
for Black Lung. Free, convenient, confidential mobile health screening
provided by CDC has proven itself as a way to markedly increase miners'
participation in CWHSP.
Question. Could we also work together on additional efforts to
address the increased incidence of black lung in coal miners?
Answer. The President's FY 2022 budget requests an additional
appropriation of $690,000 for the Black Lung Clinics Program (BLCP).
The additional appropriation will be distributed proportionally to 15
Black Lung Clinic Program grantees and will allow the clinics to
continue to provide high quality medical, outreach, educational, and
benefits counseling services to current, former, retired, and disabled
U.S. coal miners. COVID-19 has impacted these clinics, requiring
additional safety and cleaning protocols to reduce the risk of
transmission, to include the ability to purchase the necessary
equipment related to these protocols such rapid testing equipment,
installation of negative pressure rooms, UV lights and exhaust fans,
PPE, and sanitizing and disinfecting products to continue to screen,
diagnose, and treat coal miners in their facilities. I welcome the
opportunity to work with you to address this important issue for these
workers.
HRSA's BLCP and CDC's National Institute for Occupational Safety
and Health (NIOSH) continue to work with the U.S. Department of Labor's
(DOL) Office of Workers' Compensation Programs (OWCP) to align data
measures, enhance BLCP-funded clinics' ability to collect and report
patient-level data to HRSA, and improve HRSA's ability to monitor and
assess the burden of Progressive Massive Fibrosis.
______
Questions Submitted by Hon. Elizabeth Warren
Question. I was glad to see that HHS/FDA included the over-the-
counter (OTC) hearing aid proposed rule on its Spring 2021 unified
agenda. However, the FDA was supposed to put out a proposed rule no
later than August 2020--meaning the rule is over 8 months late.
Please provide a detailed timeline on when this proposed rule will
be released for public comment. Will you commit to making the release
of this rule a priority?
Answer. Thank you for your leadership on this important issue. As
you know, section 709 of the FDA Reauthorization Act of 2017 provides
certain rule-making process requirements to establish a category of OTC
hearing aids. Consistent with FDARA, FDA is a developing a proposed
rule which is a priority for the Department. The regulatory process
includes reviews at multiple levels of government. We believe that
facilitating access to hearing aids, while also ensuring patients can
depend on these products, is important. Establishing a category of OTC
hearing aids will help serve these interests by lessening regulatory
burdens and removing barriers for patients to have access to these
devices, while also ensuring that they are safe and effective.
Question. During your confirmation process, I submitted a question
for a record asking whether, as HHS Secretary, you would ``commit to
conducting a review of the Department's preexisting executive
authorities to determine how they can be used to lower the prices of
critical drugs . . . that millions of Americans rely on.'' In your
response, you said you would ``conduct a thorough review to identify
and analyze the tools at our disposal to reduce the price of drugs and
make treatments more affordable for the American people.'' Please
provide an update on this review.
What steps have you taken to analyze HHS's tools?
Which tools have you identified?
What analyses have you conducted on compulsory licensing and march-
in rights?
How is HHS planning on using these authorities to lower drug
prices, and which drugs is HHS considering targeting?
Answer. Making treatments more affordable for the American people
is a top priority of the administration. We are committed to doing a
thorough review to identify and analyze the tools available to HHS to
reduce the price of prescription drugs. The President supports reforms
that would bring down prescription drug prices, and our review of
authorities available to HHS is underway.
NIH's mission is to seek fundamental knowledge about the nature and
behavior of living systems and the application of that knowledge to
enhance health, lengthen life, and reduce illness and disability.
Essential to this mission is ensuring a continued high return on public
investment in research. There are numerous policies and regulations
surrounding the transfer of NIH technology to a company for commercial
development.
The Bayh-Dole Act was designed to address the absence of incentives
to commercialize government-funded inventions by allowing small
businesses or nonprofit organizations, such as universities, to claim
title to inventions generated during performance of a Federal grant or
contract. The Federal Government may grant a license to use the
intellectual property arising from government funding without the
permission of the rights-holder under certain circumstances, including
when ``action is necessary to alleviate health and safety needs which
are not reasonably satisfied'' or when the benefits of the patented
product are not ``available to the public on reasonable terms.''
HHS, NIH, and other agencies have been petitioned to take action
under these provisions, and HHS will continue to give such petitions
due considerations.\1\ HHS will also engage other government agencies
to address barriers to accessing government-funded inventions. The
statute provides clear constraints to these authorities, and HHS will
continue to explore opportunities to use these and other authorities in
ways that can lower the prices of medical products.
---------------------------------------------------------------------------
\1\ Another provision, 28 U.S.C. Sec. 1498, allows the Federal
Government to ``use or manufacture'' technologies protected under
current U.S. patents, while giving the patent owner ``recovery of his
reasonable and entire compensation for such use and manufacture'';
https://uscode.
house.gov/view.xhtml?req=granuleid:USC-prelim-title28-
section1498&num=0&edition=prelim.
Question. Does the CDC plan to extend the Federal eviction
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moratorium?
Answer. The CDC eviction moratorium took effect September 4, 2020
and was initially slated to extend through December 31, 2020. However,
it was extended legislatively through January 31, 2021, and extended
again by CDC through March 31, 2021. On March 29, 2021, CDC further
extended the moratorium until June 30, 2021.
Question. In releasing updated guidance on mask-wearing in May
2021, did the CDC consult with the Department of Labor, OSHA, labor
groups, or any workplace safety experts?
Is the CDC considering providing updated guidance with a focus on
the threat of workplace exposure, that addresses issues such as
mitigation measures needed to protect workers in workplaces where large
numbers of both vaccinated and unvaccinated people work in enclosed
spaces, and in workplaces where workers come into frequent contact with
coworkers or members of the public who are both vaccinated and
unvaccinated?
Answer. CDC is continuing to update guidance documents based on the
best available science and based on the trajectory of the pandemic in
the United States. CDC is also working to make them applicable to
multiple settings and scenarios. This will make it more efficient to
search and find relevant public health guidance.
The Occupational Safety and Health Administration (OSHA) updated
its guidance on mitigating and preventing the spread of COVID-19 in the
workplace in June 2021, and it remains a resource for businesses. CDC
and HHS assisted OSHA's development and review of the updated
information for business, employers, and workers that provides guidance
for all industries (excluding health care and certain other settings),
including information on vaccinations in the workplace and how varying
vaccination status among workers influences workplace control measures.
CDC has specific guidance for health-care settings which includes
comprehensive recommendations for protecting health-care personnel,
patients, residents, and visitors in a health-care setting from SARS-
CoV-2 transmission. CDC's health-care guidance also includes
information on modifications to existing infection control guidance
that might be implemented based on vaccination status. This guidance
has been updated regularly to reflect new information on the
epidemiology of current infections and the science underlying our
understanding of transmission.
______
Questions Submitted by Hon. Richard Burr
Question. This year's budget includes the largest increase for CDC
in almost 20 years. A funding increase on its own won't be enough to
achieve necessary structural and cultural reforms for the agency.
What are you and CDC leadership doing to encourage cultural shifts
that help the American people trust CDC leaders, data, and guidance
today and in the face of future threats?
Answer. HHS and CDC are working to ensure that public health
decisions are based on the highest-quality scientific information.
Looking to the future, I want to work within the administration and
with you to address longstanding vulnerabilities in our core public
health infrastructure, including data, workforce, laboratory, domestic
preparedness, and global health security. We must work together over
the months and years ahead to reinforce the foundations, partnerships,
modernizations, and innovations that we have initiated during this
pandemic--ensuring robust public health systems continue to be grounded
in science.
Question. Public-private partnerships have been the key to our
success in combating COVID-19. Leaders within our government agencies
should hear from innovators with novel technologies to understand what
is available to address some of our most challenging and complex
issues, especially in health care.
Is there any official policy preventing these types of meetings
between industry leaders and the heads of your non-regulatory public
health agencies?
Do you think it would be beneficial for principals of HHS agencies
to have the same opportunity to meet with these companies?
Answer. We will continue to partner with other Federal agencies,
States, and the private sector to execute a whole-of-America response
to this pandemic in accordance with current applicable Federal laws and
departmental and agency policies.
Question. The FDA user fee programs are critical to ensuring that
patients have access to medical products. These programs supplement
FDA's congressionally appropriated resources to keep pace with science
and bring cutting-edge medical treatments to patients who need them.
FDA's growing reliance on industry user fees results in less
accountability to Congress, and therefore, American patients and
families. How does your budget ensure that FDA is accountable to
patients and taxpayers?
Answer. I believe that FDA's user fee programs offer a strong
example of what can be achieved when Congress, FDA, industry, and other
stakeholders work together towards the same goal. The user fee programs
have allowed FDA to speed the application review process without
compromising the agency's high standards. The user fees provide a
critical way to ensure that FDA has the resources needed to conduct
reviews in a timely fashion.
Question. The budget proposal includes an increase of $37.5 million
(for a total of $347.6 million) for infrastructure, buildings, and
facilities at the FDA; $19.5 million for infrastructure, with $2.5
million for White Oak; and $18 million for buildings and facilities.
What will the $2.5 million for White Oak be spent on?
What will the $18 million for buildings and facilities go towards?
What proposed resources are included for activities like the
purchase of furniture, scientific equipment, or other materials and
supplies?
Answer. Funding for Infrastructure--GSA Rent, Other Rent and Rent-
Related (OR&RR), and White Oak Consolidation--and Buildings and
Facilities (B&F) provides the facilities, infrastructure, and utilities
required by FDA's workforce to carry out its public health mission,
respond to food safety and medical product emergencies, and protect and
promote the safety and health of American families. FDA facilities
directly support its strategic priorities by ensuring FDA staff have
the modern infrastructure and labs across the country to execute the
agency's vital public health mission. It is important that these
facilities provide safe, suitable and reliable work environments and to
support changing scientific and regulatory requirements and technology.
Question. Two of the COVID-19 vaccines use a messenger RNA (mRNA)-
based platform.
What resources in your budget are dedicated to improve the ability
for FDA to more efficiently review products that incorporate platform
technologies?
Answer. FDA undertakes preparations to respond to a wide variety of
natural and human-caused threats and public health emergencies (e.g.,
COVID-19) that involve, affect, or require the use of FDA-regulated
products to help keep the public safe. FDA carries out many activities
to protect and promote public health to prevent a public health
emergency, and, when one occurs, during a public health emergency.
Specifically, the President's FY 2022 budget includes $153,113,000 for
bioterrorism/medical countermeasures and $39,591,000 for pandemic
influenza.
FDA centers are committed to promoting development of innovative
products, including platform technologies. Throughout the pandemic the
agency has utilized significant resources towards meetings, guidance,
review, and surveillance of innovative products to treat and prevent
COVID-19. Specifically, we have dedicated significant resources to the
review and monitoring of mRNA products and other COVID-19 vaccines.
Question. During your confirmation process you indicated that you
share my goal of ensuring FDA and CMS are working more closely
together. The FDA's recent approval of a first-of-its-kind treatment
for Alzheimer's disease will put your words to the test.
Currently, Medicare won't provide coverage of the diagnostic
imaging necessary to determine whether a patient is a candidate for
this new treatment. How CMS approaches coverage of the treatment and
diagnostic is of critical importance for Alzheimer's patients and
caregivers.
What investments does the budget include to modernize CMS processes
to ensure more timely access to novel medical products?
I recently sent you a letter requesting that CMS reassess its
current policies and provide coverage of the necessary screening test
to remove barriers for patients accessing an approved treatment for
Alzheimer's disease. When can I expect a response to my request?
Answer. The FDA has approved Aduhelm for the treatment of
Alzheimer's disease and Medicare beneficiaries can begin receiving this
drug today as long as its use is reasonable and necessary under the
Medicare statute. Medicare Administrative Contractors make claim-by-
claim determinations regarding whether items or services are reasonable
and necessary. If a provider has questions about coverage of Aduhelm,
they should contact their local Medicare Administrative Contractor for
more information. It is my goal to respond to letters timely and I will
check in with my staff on the status of your letter.
Question. CMS recently announced that it would be reviewing an
approved 1332 waiver granted to the State of Georgia. The
administration cited changes in Federal law and administrative policies
as the reason for reviewing the already approved waiver. These Federal
policy changes apply to many States, however, not just Georgia.
Is the Department planning to review other approved 1332 waivers in
response to these shifts in Federal policy? If so, which States?
Answer. The Department of Health and Human Services and the
Department of the Treasury are reviewing all section 1332 waivers in
light of recent changes in Federal law and policies, including the
enactment of the American Rescue Plan Act of 2021 and the adoption of
Executive Order 13985 and Executive Order 14009. This administration is
committed to protecting and expanding Americans' access to quality,
affordable health care and making the health-care system easier to
navigate. Through section 1332 waivers, the Department aims to assist
States with developing health insurance markets that expand coverage,
lower costs, and ensure that health care truly is a right for all
Americans.
Question. A number of Medicare and Medicaid policies are currently
slated to remain in effect until the public health emergency ends. As
such, your budget model must assume an end date of the emergency to
accurately forecast spending.
When does the President's budget assume the emergency will end?
Answer. The PHE is assumed to continue at least through the 2021
calendar year in the FY 2022 President's budget baseline. The actual
timing will depend on progress against the pandemic. The Families First
Coronavirus Response Act (Pub. L. 116-127) provides a temporary
additional 6.2 percentage points to the Federal Medical Assistance
Percentage (FMAP) during the PHE and it expires at the end of the
quarter in which the PHE ends.
Question. Cyberattacks against the health-care sector have
dramatically increased over the past several years, spiking since the
onset of the COVID-19 pandemic.
What does your budget do to defend our health-care sector and
coordinate prevention and response efforts among the public and private
health sectors?
Answer. HHS plays a significant role in enhancing and protecting
the health and well-being of all Americans by preparing for and
responding to cybersecurity threats. This budget supports the
operations of the following HHS entities that are responsible
cybersecurity assistance to the health care and public health (HPH)
sector:
The HHS Office of the Assistant Secretary for Preparedness and
Response (ASPR) Critical Infrastructure Protection Division is the
sector risk management agency. It promotes resilience in the sector to
manage risk and coordinate an effective response to new cybersecurity
threats.
The Office of Information Security Cybersecurity Governance Risk
and Compliance Division supports the department's role as sector risk
management agency by coordinating efforts to improve the cybersecurity
of the sector with public and private industry partners. The division
manages and implements the requirements of section 405(d) of the
Cybersecurity Act of 2015, which directs HHS to improve cybersecurity
in the health-care industry by taking actions towards aligning health-
care industry security approaches.
The Health Sector Cybersecurity Coordination Center (HC3) enables
improved cybersecurity information sharing between HHS, its Federal
partners, and the HPH sector. HC3 collaborates with the HPH sector to
understand cyber threats, learn adversaries' patterns and trends, and
provide information and approaches on how the sector can better defend
itself.
Question. How is HHS coordinating with other Federal agencies in
their cybersecurity response and prevention?
Answer. As required by the Pandemic and All-Hazards and Advancing
Innovation Act of 2019, ASPR led the development of a ``strategy for
public health preparedness and response to address cybersecurity
threats.'' This strategy is in final clearance within the Department
and is anticipated to be delivered to Congress soon. Confronting
cybersecurity threats requires contributions from across the Federal
Government, including the Department of Homeland Security's
Cybersecurity and Infrastructure Security Agency, the Federal Bureau of
Investigation's National Cyber Investigative Joint Task Force, and
other Federal Government organizations such as the National
Cybersecurity Center of Excellence (NCCoE), as well as from other
stakeholders, to include States and the private sector with expertise
or authorities relevant to the cybersecurity and resiliency of the
health sector. This strategy identifies duties, functions,
preparedness, and response goals for which HHS is responsible for the
Healthcare and Public Health (HPH) Sector. It also includes strategies
to address identified gaps and strengthen public health emergency
preparedness and response capabilities.
______
Questions Submitted by Hon. John Cornyn
Question. More than 4 million Texans, including half of all
children in the State, depend on the stability of the State's Medicaid
program for themselves and their families. Over 50 percent of inpatient
days in our children's hospitals are paid for by Medicaid, and vital
mental health providers like Certified Community Behavioral Health
Clinics rely on funding through Medicaid and our 1115 waiver.
In April, the Biden administration rescinded approval of Texas's
1115 waiver extension. This unprecedented action by CMS threatens the
security of the State's Medicaid program, disrespects the continuity of
this agreement, and erodes the partnership between the State and CMS.
While our current waiver runs through September 2022, the extension
addressed a funding cliff that puts at risk access to vital services
for our most vulnerable.
The last time you came before this committee there was a discussion
about waivers and you committed to working with States in their efforts
to provide care for these vulnerable populations. It is my
understanding from CMS that the decision to review the waiver agreement
was made in February and neither Texas nor the congressional delegation
was informed of this until the waiver was rescinded.
Given your desire to work with States on these efforts, why was
Texas not informed that a review which ultimately led to the waiver
being rescinded was happening?
Is this the type of engagement we should expect from the
administration moving forward?
Can you commit to providing Texas with a fair and expeditious
review of a subsequent waiver application?
Answer. The partnership between States and the Federal Government
is central to Medicaid, and this administration is committed to working
with States to strengthen this vital program. HHS is committed to
supporting State innovation and States' ability to test different
models that meet the unique needs of their residents and to ensure
open, and timely communication with our State partners. Medicaid is an
important lifeline for many American families. It is important that
States' Medicaid section 1115 demonstrations promote the objectives of
the Medicaid program and comply with the requirements of section 1115
and its implementing regulations.
I agree that States need certainty and predictability from the
Federal Government, and it's important that HHS works closely with
States to help them explore ways to address the unique needs of their
residents. We look forward to continuing to work with Texas.
Question. I'd like to ask you about your budget request of $3.3
billion for the unaccompanied children program. Among its other
responsibilities, HHS is responsible for ensuring the well-being of
unaccompanied migrant children who are placed with sponsors.
I believe that we need to invest more resources in vetting these
sponsors and following up with the children who are placed with them. A
couple years ago, the HSGAC Permanent Subcommittee on Investigations
released a report that found that a number of children placed with
sponsors were forced to work on an egg farm in Ohio in 2015.
The subcommittee also uncovered a number of other instances of
abuse, including children were withdrawn from school and forced to work
long hours, and a sponsor who beat a child with an electrical cord.
In the case of the child who was beaten with an electrical cord,
the subcommittee concluded that HHS should have conducted a home study
before placing the child, but did not do so. Furthermore, in the first
3 months of this fiscal year, HHS has been unable to reach
approximately 20 percent of the children who are placed with sponsors
30 days after release.
Can you commit to using the funds requested for the unaccompanied
children program to enhance vetting of sponsors and services to ensure
that children are safe after they are placed with those sponsors?
Answer. Yes, the budget request includes expanding the scope of
post-release services and the number of children who receive them. The
budget request will also support the ongoing implementation of other
critical programmatic reforms, such as improved case management that
reduces the time it takes to safely unify children with their vetted
sponsors.
Question. The mental health and welfare of American citizens is
foremost on my mind these days. The United States spends enormous sums
of money each year to make services available to Americans struggling
with a mental or behavioral health medical condition. However, COVID-19
has laid bare an uncomfortable truth for policymakers--how we plan for
and spend these funds isn't working as well as it could.
There are unmet needs and other problems without our local health
systems that we need to begin solving for this year. For instance, our
medical workforces are unable to meet all of the crisis care needs that
exist in our communities today. The expected success of the 988 crisis
hotlines when they are up and running shortly will increase service
requests even more. These issues are immediate and work should be
undertaken to address them immediately.
However, this committee should not stop there.
I will be working with a bipartisan group of Senators to develop a
vision for reimagined systems of mental and behavioral health in
communities all across America. A legislative and regulatory initiative
that correctly considers mental well-being to be a basic and
foundational aspect of American society throughout all stages of life--
from birth to death. A modern system with a workforce capable of
managing the needs of its communities. A system designed to not only
improve the health-care response but also provide access to other
important resources like early and continued education. A Federal
approach to community support that properly balances the needs of local
communities with the national interests of the Federal Government.
We would like to work with you. This is a non-partisan problem in
need of bold solutions, and I believe the administration's support and
collaboration of our efforts could be extremely important for our
future success. Will you work with us, Mr. Secretary?
Answer. I commend your emphasis on the need for systems improvement
to address the behavioral health needs in America's communities,
particularly in the aftermath of COVID-19. HHS is in agreement that
mental well-being is a critical element in the health of the country
and that a number of factors which negatively impact health and well-
being need to be addressed simultaneously, including access to quality
care, building and sustaining a sufficient workforce and addressing
social determinants which intersect with health burden. SAMHSA's
implementation of the 988 suicide prevention and mental health crisis
hotline presents unique opportunities to transform the system of care
so that individuals receive help where and when they need it so that
adverse outcomes are minimized. I look forward to ongoing partnership
to realize the potential of this transformative moment.
Question. Along with Senator Bennet, I have introduced S. 1427, the
Increasing Access to Biosimilars Act. This proposal, which was
introduced in both the House and Senate, would implement a shared
savings program where Medicare savings associated with prescribing a
biosimilar would be shared with providers and more importantly patients
through reduced co-pays. We have previously spoken about the potential
of a shared savings approach to help reduce the cost of prescription
drugs and boost biosimilar uptake.
Is this something the administration has discussed through CMMI or
other avenues available?
If not, are you looking at other ways to incentivize the uptake of
lower-cost biosimilars?
Answer. Prescription drug costs are too high for American patients
and families. From the meetings I have had with Senators, I have seen
that lowering drug prices is a priority on both sides of the aisle. I
agree that patient access to lower-cost generics and biosimilars is
important. Competition in the market has helped control the growth in
spending on prescription drugs, and generics and biosimilars certainly
have a role to play in creating competition for reference products. I
look forward to working with you and others in Congress to lower the
cost of prescription drugs.
______
Questions Submitted by Hon. Chuck Grassley
Question. The Grassley-Warren Over-the-Counter (OTC) Hearing Aid
Act was signed into law in 2017 and required the Food and Drug
Administration (FDA) to issue draft rules by August 2020, but the
agency failed to do so. In November 2020, I sent a letter along with
Senator Warren to the FDA urging them to initiate overdue rulemaking.
To date, the FDA has taken no action. They have communicated the draft
regulations are under legal review. On June 9, 2021, Secretary Becerra
stated, ``I know that we are in the works. I asked about this myself.''
At a House Energy and Commerce Committee hearing on May 12, 2021, he
made similar comments, stating, ``It is still undergoing review.''
Given Secretary Becerra has been asked similar questions from
Congress over a 5-week period and had another week to provide an answer
I am asking again, what is the timeline for the FDA to issue the over-
the-counter hearing aids regulations?
If a timeline is not set or cannot be provided, what agency and
office in the executive branch is currently reviewing the draft
regulations?
Answer. Thank you for your leadership on this important issue. As
you know, section 709 of the FDA Reauthorization Act of 2017 provides
certain rulemaking process requirements to establish a category of OTC
hearing aids. Consistent with FDARA, FDA is a developing a proposed
rule which is a priority for the Department. The regulatory process
includes reviews at multiple levels of government. We believe that
facilitating access to hearing aids, while also ensuring patients can
depend on these products, is important. Establishing a category of OTC
hearing aids will help serve these interests by lessening regulatory
burdens and removing barriers for patients to have access to these
devices, while also ensuring that they are safe and effective.
Question. At the June 10, 2021 hearing, I asked you this question
but you failed to directly respond. On March 8, 2021, I wrote to the
Department of Health and Human Services (HHS) and asked several
questions relating to the origins of the coronavirus. I also asked
about what, if any, oversight was done on the coronavirus grants sent
by Dr. Fauci's unit within the National Institutes of Health to
EcoHealth Alliance which issued sub-grants to the Wuhan Institute of
Virology. According to reports, $600,000 to $826,000 was sent to the
Wuhan Institute of Virology by EcoHealth Alliance to study bat
coronaviruses. On May 21, 2021, the Department of Health and Human
Services responded to my letter but failed to answer whether any
oversight was done. On May 26, 2021, I wrote a follow-up letter to the
Department of Health and Human Services asking again what, if any,
oversight was done. I have not received a response yet, as of July 16,
2021.
Did the Department of Health and Human Services, specifically Dr.
Fauci's unit, do any oversight of the taxpayer money sent to the Wuhan
Institute of Virology?
If so, can you say with certainty that the money wasn't misused by
the Chinese government, including with gain-of-function research?
If no oversight was done, please explain why that's the case.
Answer. The application from EcoHealth Alliance was subjected to
NIH's two-stage review process in which both scientific review (i.e.,
rigorous peer review) and NIH review (Advisory Council review)
occurred. Once awarded, adherence to the NIH Grants Policy Statement
became a term and condition for funds to be disbursed and mechanisms
for monitoring awards are detailed in Chapter 8.4 of the NIH Grants
Policy Statement.\2\ Notably, the application submitted to NIH by
EcoHealth Alliance, did not propose research to enhance any coronavirus
to be more transmissible or virulent in the human population and NIH
would not have approved this research. The results of the approved
proposal and funded Wuhan Institute of Virology experiments were
published contemporaneously in peer-reviewed scientific literature to
inform the global scientific community of its findings in accordance
with NIH policies.
---------------------------------------------------------------------------
\2\ https://grants.nih.gov/grants/policy/nihgps/nihgps.pdf.
Question. In July 2020, as chairman of the Senate Finance
Committee, I held two hearings to discuss how the United States can
protect the reliability of our country's medical supply chain during
COVID-19. This hearing convened U.S. government officials and a panel
of industry experts to discuss the difficulties we faced securing PPE
and other critical medical supplies during the pandemic. (Many of these
goods are made abroad, in foreign countries like China.) On June 8,
2021, the Biden administration announced its plan to convene a task
force to address short-term supply chain issues. The plan focuses on
four critical products: semiconductor manufacturing, large capacity
batteries, like those for electric vehicles, critical minerals and
materials, and pharmaceuticals and active pharmaceutical ingredients
(API). However, this plan does not take into account supply chain
issues related to PPE and other medical equipment--items that hospitals
and other health care providers found impossible to source at the
beginning of the pandemic. This pandemic has made it abundantly clear
that we as a Nation can no longer count on other countries, like China,
---------------------------------------------------------------------------
to be the sole source of our medical supplies.
How does HHS plan to address supply chain vulnerabilities for PPE
and other medical supplies?
Does HHS have plans to work with its private sector partners to
onshore certain essential medical supplies and, if so, what supplies is
HHS targeting? If not, why not?
Answer. The global pandemic has highlighted the vulnerabilities of
the global supply chain. It is critical that steps are taken to invest
in expansion of U.S. domestic manufacturing capacity. To that end, the
Office of the Assistant Secretary for Preparedness and Response (ASPR)
is leveraging the authorities delegated to the Secretary under the
Defense Production Act (DPA) to ensure that private-sector partners
making life-saving products are able to acquire raw materials, retool
their machinery, scale their production facilities, train their
workforces, and ultimately deliver their product. Throughout the COVID-
19 response, ASPR has used the DPA authority to issue 46 priority
ratings for United States Government (USG) contracts for health
resources, eight priority ratings for USG contracts for industrial
expansion, 3 priority ratings for non-USG contracts to indirectly
support COVID-19 and/or mitigate the potential stockout of critical
lifesaving therapies. Going forward, ASPR will continue to build
capacity and partnerships with private industry toward the shared goal
of ending the COVID-19 pandemic.
ASPR is also working to support efforts in expanding the domestic
industrial base. These industrial base expansion (IBx) efforts seek to
reduce supply chain vulnerabilities and generate a domestic ``warm-
base'' for manufacturing that can be leveraged in a crisis. Consistent
with the shift towards onshoring essential medical supplies, since the
Spring of 2020, all 12 SNS contracts, worth approximately $380 million,
for N95 respirators were for products manufactured in the U.S.
Furthermore, with $10 billion received for industrial base expansion,
ASPR has been establishing and maintaining domestic capacity for
critical supplies. ASPR has invested funding to support PPE production;
active pharmaceutical ingredient manufacturing capacity; additional
COVID-19 testing supplies, to include swabs, tests, kits, and supplies
such as reagents and resins; and raw materials to support vaccine
industrial base expansion for raw materials, consumables, fill/finish
capacity, needles, vials, and syringes.
Lastly, ASPR's Hospital Preparedness Program (HPP) included two
requirements in the FY 2019-2023 funding opportunity announcement to
help address supply chain vulnerabilities. First, HPP recipients and
their health care coalitions must conduct a supply chain integrity
assessment to evaluate equipment and supplies that will be in demand
during emergencies and develop mitigation strategies to address
potential shortfalls. Second, each health care coalition must update
and maintain a regional resource inventory assessment.
Question. How is HHS working with its private-sector partners to
ensure that corporations have stockpiles of select medical equipment to
ensure resiliency in the future?
Answer. ASPR's Hospital Preparedness Program (HPP) supports
collaboration with private sector partners for broader health care
resiliency and readiness through its investment in health-care
coalitions (HCCs), which are groups of individual health care and
response organizations in a defined geographic location that play a
critical role in developing health-care delivery system preparedness
and response capabilities. HCC members actively contribute to strategic
planning, operational planning and response, information-sharing, and
resource coordination and management. As a result, HCCs collaborate to
ensure each member has what it needs to respond to emergencies and
planned events, including medical equipment and supplies, real-time
information, communication systems, and educated and trained health-
care personnel.
Question. On May 6, 2021, Senator Wyden and I wrote to Department
of Health and Human Services (HHS) in order to raise concerns related
to your joint investigation of HHS Office of Refugee Resettlement's
(ORR) unaccompanied alien children (UAC) program. In our letter, we
asked about recent instances of abuse and about the steps HHS is taking
to ensure that volunteers are properly trained and educated about the
history of safety hazards and child abuse at UAC facilities. The
response was due on May 20, 2021. On May 18, 2021, I led a group of
Senators in writing another letter to HHS asking for details about
HHS's effort to address personnel shortages at border facilities by
recruiting volunteers from other parts of the Federal Government,
including agencies such as NASA and the USDA. Our letter asked
questions about the nature, extent, and cost of the volunteer program.
The response to that letter was due on June 1, 2021. I have not
received a response to either letter.
When can my colleagues and I expect responses to our letters?
Answer. Thank you for your continued interest in the Unaccompanied
Children program. The Department is working to respond to your letters
and will have a response to you very shortly. I take congressional
inquiries and letters very seriously and hope moving forward the
Department is able to provide you with a more timely response.
According to the USA Jobs website, ORR's request for detailees from
outside agencies to assist at border facilities closed on May 21st. Is
it accurate that HHS is no longer seeking volunteers?
Answer. HHS continues to deploy Federal detailees who previously
applied through the detail solicitation process. While HHS is not
currently recruiting additional new detailees, HHS is still actively
deploying detailees who previously applied to EIS locations, to ORR
headquarters operations in Washington, DC, and for virtual assignments
in support of the UC mission.
Question. In total, how many Federal employees from outside of HHS
have received detail assignments to assist at border facilities? Which
agencies are they from?
Answer. As of June 10, 2021, a total of 2,263 Federal employees
were deployed to assist the Unaccompanied Children program, either in-
person or virtually. Please see the table below for a complete list of
Federal detailees' home agencies.
------------------------------------------------------------------------
Total Number of
Number of Federal Federal Personnel
Department Personnel Deployed Deployed From 3/1/
on 6/10/2021 21 to 6/10/2021
------------------------------------------------------------------------
ARMED FORCES RETIREMENT HOME - 1
------------------------------------------------------------------------
COUNCIL OF THE INSPECTOR - 1
GENERAL ON INTEGRITY AND
EFFICIENCY
------------------------------------------------------------------------
COURT SERVICES AND OFFENDER 5 14
SUPERVISION AGENCY FOR THE
DISTRICT OF COLUMBIA
------------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE 20 184
------------------------------------------------------------------------
DEPARTMENT OF COMMERCE 3 10
------------------------------------------------------------------------
DEPARTMENT OF DEFENSE 1 17
------------------------------------------------------------------------
DEPARTMENT OF EDUCATION 2 43
------------------------------------------------------------------------
DEPARTMENT OF ENERGY 6 37
------------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN 115 1,006
SERVICES
------------------------------------------------------------------------
DEPARTMENT OF HOMELAND 1 6
SECURITY
------------------------------------------------------------------------
DEPARTMENT OF HOUSING AND 4 47
URBAN DEVELOPMENT
------------------------------------------------------------------------
DEPARTMENT OF JUSTICE 7 48
------------------------------------------------------------------------
DEPARTMENT OF LABOR 7 69
------------------------------------------------------------------------
DEPARTMENT OF THE INTERIOR - 2
------------------------------------------------------------------------
DEPARTMENT OF THE TREASURY 3 23
------------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION 4 35
------------------------------------------------------------------------
ENVIRONMENTAL PROTECTION 13 147
AGENCY
------------------------------------------------------------------------
EQUAL EMPLOYMENT OPPORTUNITY 4 35
COMMISSION
------------------------------------------------------------------------
EXPORT-IMPORT BANK OF THE - 1
UNITED STATES
------------------------------------------------------------------------
FARM CREDIT ADMINISTRATION - 4
------------------------------------------------------------------------
FEDERAL DEPOSIT INSURANCE - 4
CORPORATION
------------------------------------------------------------------------
FEDERAL FINANCIAL INSTITUTIONS 1 1
EXAMINATION COUNCIL
------------------------------------------------------------------------
FEDERAL LABOR RELATIONS - 2
AUTHORITY
------------------------------------------------------------------------
FEDERAL MARITIME COMMISSION - 2
------------------------------------------------------------------------
FEDERAL MEDIATION AND - 4
CONCILIATION SERVICE
------------------------------------------------------------------------
FEDERAL MINE SAFETY AND HEALTH - 1
REVIEW COMMISSION
------------------------------------------------------------------------
FEDERAL TRADE COMMISSION 1 10
------------------------------------------------------------------------
GENERAL SERVICES 17 139
ADMINISTRATION
------------------------------------------------------------------------
INTER-AMERICAN FOUNDATION 1 3
------------------------------------------------------------------------
INTERNATIONAL BOUNDARY AND - 2
WATER COMMISSION: UNITED
STATES AND MEXICO
------------------------------------------------------------------------
NATIONAL AERONAUTICS AND SPACE 1 6
ADMINISTRATION
------------------------------------------------------------------------
OFFICE OF MANAGEMENT AND - 2
BUDGET
------------------------------------------------------------------------
OFFICE OF PERSONNEL MANAGEMENT 4 31
------------------------------------------------------------------------
PEACE CORPS 2 15
------------------------------------------------------------------------
RAILROAD RETIREMENT BOARD - 1
------------------------------------------------------------------------
SOCIAL SECURITY ADMINISTRATION 67 319
------------------------------------------------------------------------
U.S. AGENCY FOR INTERNATIONAL - 2
DEVELOPMENT
------------------------------------------------------------------------
U.S. COMMISSION ON 1 1
INTERNATIONAL RELIGIOUS
FREEDOM
------------------------------------------------------------------------
U.S. INTERNATIONAL TRADE - 4
COMMISSION
------------------------------------------------------------------------
U.S. POSTAL SERVICE - 2
------------------------------------------------------------------------
GRAND TOTAL 290 2,263
------------------------------------------------------------------------
Question. What steps has HHS taken to ensure that the individuals
responsible for training new volunteers are knowledgeable about ongoing
risks at UAC facilities, including the heightened risk of abuse and any
ongoing safety concerns at the specific facilities where volunteers are
being placed?
Answer. ORR's primary mission is to ensure the safety and well-
being of the unaccompanied children in its care. ORR recognizes that
children who enter ORR care may have experienced significant trauma not
only in their home country but also during their journey to the United
States. ORR staff have years of experience working with vulnerable
populations and are knowledgeable about the specific needs of children
in ORR care. Individuals responsible for providing new trainings for
detailees, such as the ORR's Prevention of Sexual Abuse (PSA) team,
have years of experience as well as child welfare expertise. The PSA
team is responsible for delivering trainings to all staff, detailees,
contractors, and anyone who may have direct contact with children in
ORR care.
Question. As you are aware, ORR is currently working to create of a
new software program to replace the ``Portal'' that it uses to track
reports of abuse and the movement of UAC through the system. When do
you expect the software to be implemented, and are you confident that
this program will address ongoing concerns with the Portal?
Answer. ORR has been working to improve the current system (the UC
Portal) and planning to migrate to the new platform (the UC Path). ORR
expects to begin a progressive, phased migration to a new environment
in the fall of 2021, finishing in 2022. This includes monitoring the
development and incorporation of data fields into the UC Path that will
improve tracking and trending capabilities to better safeguard minors
in ORR care. The UC Path is expanding the data point entries for
incident report information as compared to the UC Portal. Long term,
ORR is working with Department of Homeland Security (DHS) agencies in
the development of the Unified Immigration Portal (UIP), which will
connect DHS systems and ORR's UC Path system to strengthen interagency
cooperation and communication in support of ORR's mission.
Question. In 2019, I passed the bipartisan Advancing Care for
Exceptional (ACE) Kids Act with the help of Senator Bennet. It will
align Medicaid rules and payment to incentivize coordination and
improved health outcomes. This Congress, I am working with Senator
Bennet to build onto ACE Kids Act with the Accelerating Kids' Access to
Care Act that would streamline the screening and provider enrollment
process for Medicaid providers serving children with complex medical
conditions. The Centers for Medicare and Medicaid Services (CMS) noted
its interest in streamlining provider enrollment and screening by
acknowledging its ongoing Provider Enrollment, Chain, and Ownership
System (PECOS) 2.0 activities in CMS's fiscal year 2022 budget
justification (https://www.cms.gov/files/document/fy2022-cms-
congressional-justification-estimates-appropriations-committees.pdf).
Do you believe CMS's PECOS 2.0 efforts align with the goals of the
Accelerating Kids' Access to Care Act?
If so, can CMS provide technical assistance for the Accelerating
Kids' Access to Care Act?
Answer. PECOS is the system of record for all Medicare provider/
supplier enrollment data, which includes Part A, Part B, and DME. PECOS
2.0 is a ground-up redesign of the current system, and CMS is focused
on modernizing the system to create an enterprise resource that is a
platform for all enrollments across Medicare, Medicaid, and emerging
provider programs. We are always happy to work with you to provide any
requested technical assistance on legislation.
Question. The 2019 Advancing Care for Exceptional (ACE) Kids Act
requires the Centers for Medicare and Medicaid Services (CMS) to issue
guidance to State Medicaid directors on the coordination of care from
out-of-state providers for children with medically complex conditions.
CMS issued an request-for-information (RFI) in January 2020 to seek
public comment (https://www.federalregister.gov/documents/2020/01/21/
2020-00796/coordinating-care-from-out-of-state-providers-for-medicaid-
eligible-children-with-medically-complex). The RFI was reopened for an
additional 30 days in May and June 2020 (https://
www.federalregister.gov/documents/2020/05/04/2020-09392/coordinating-
care-from-out-of-state-providers-for-medicaid-eligible-children-with-
medically-complex).
In follow-up to the RFI, CMS is required to issue guidance to State
Medicaid directors, what is the status of CMS issuing guidance to State
Medicaid directors?
If a status update on the guidance cannot be provided, what is the
expected timeline to issue the guidance?
Answer. CMS is currently drafting guidance to States on the topics
listed at section 1945A(e)(1) of the Social Security Act. The guidance
is being informed by the information CMS received in response to its
January 2020 Request for Information (RFI) entitled ``Coordinating Care
From Out-of-State Providers for Medicaid-Eligible Children With
Medically Complex Conditions.'' We look forward to providing additional
updates related to this guidance as they become available.
Question. The Centers for Medicare and Medicaid Services (CMS)
reportedly only informs the public of fines imposed against nursing
homes after the nursing homes are compelled to begin paying the fines
(which can take some time, due to the availability of an appeals
process). The Iowa Capital Dispatch reported this month:
For most of the past year [CMS's] Care Compare website (https:/
/www.medicare.gov/care-compare/) has falsely reported that the
Dubuque Specialty Care nursing home in eastern Iowa had a
perfect, deficiency-free inspection in June 2020. In fact,
State inspectors found numerous, serious violations, and CMS
imposed a fine of $84,825, which was immediately reduced to
$55,136 once the home agreed to forego an appeal. . . .
[A]n agency spokesman in CMS' Office of Communications said
``human error'' had caused the agency to post a false
deficiency-free inspection report for the Dubuque home on its
website, though he was unable to say how or why such a report
was created. As for the website's separate claim that the
Dubuque home was never fined as a result of the June 2020
inspection, the spokesman attributed that assertion to the fact
that ``the facility has not yet begun to submit payments''
toward the fine. He said CMS' ``normal process'' in cases of
unpaid fines is to refer the matter to an administrative
contractor who will initiate collection by offsetting Medicare
payments owed to the home. ``Once this begins, the fine will be
reflected on the Care Compare website,'' the spokesman said.
My understanding is that the Department's Care Compare website
includes information about fines that are imposed against nursing homes
as a result of nursing home inspections that took place within the last
three years. It's also my understanding that the imposition of the
fines will typically remain undisclosed to the public during the
sometimes lengthy period in which nursing homes exhaust the appeals
process.
Is this an accurate statement of CMS's current policy?
If so, are there occasions on which nursing home fines may never be
reported to the public because the process of appealing a fine can take
more than 3 years to resolve?
If yes, how often does this actually occur in practice, that the
imposition of a fine will never be disclosed on the Care Compare
website?
What could CMS do to improve Care Compare to ensure that the public
eventually gets access to this information?
Answer. CMS is committed to ensuring that every nursing home
serving Medicare and Medicaid beneficiaries is meeting Federal
requirements to keep its residents safe and provide high-quality care.
A critical part of our efforts is providing the public with accurate
and meaningful information about nursing homes, including inspection
results and Federal fines or other penalties incurred as a result of a
nursing home receiving a serious health or fire safety noncompliance
citation. By using a Five-Star Quality Rating System, CMS's Care
Compare website strives to provide residents and their families with an
easy way to compare performance history between nursing homes and help
them make important decisions about their care. It is critical for this
information to be accurate and up-to-date, and CMS continues to improve
the Care Compare website and the Five-Star Quality Rating System.
As part of the provider's due process rights, States are required
to offer an opportunity for informal dispute resolution (IDR). The IDR
process was implemented to ensure that facilities receive a fair and
appropriate decision based on evidence. It is important to note that
while the IDR process generally takes about 60 days to complete,
enforcement actions and corrections of noncompliance are not delayed
during this period. CMS posts the results of surveys online after the
IDR is completed to allow the process to conclude and to ensure that
the findings reflected are accurate. In addition to initiating an IDR,
providers have the option to formally appeal the noncompliance citation
that led to enforcement actions. Although the process of appealing a
citation may take months or even years, CMS wins the vast majority of
these cases and posts deficiencies on Care Compare even while they are
being appealed. Like all complex data reporting systems, Care Compare
may occasionally experience data entry or display issues. Once CMS
becomes aware of these errors, including errors that prevent some
deficiencies from being properly displayed, the agency works to correct
them as quickly as possible. CMS has a robust quality assurance process
and is always looking to improve its systems. I look forward to working
with you and stakeholders across the industry to address these issues
and continue to improve the Care Compare website.
Question. The Iowa Capital Dispatch reported recently:
The list of the Nation's worst-performing nursing homes,
compiled by the Federal Centers for Medicare and Medicaid
Services (CMS), is known as the special-focus facilities list
(https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/CertificationandComplianc/Downloads/SFF
List.pdf), and is updated quarterly. The special-focus
facilities are those deemed by CMS to have ``a history of
serious quality issues'' and they are enrolled in a special
program that is intended to stimulate improvements in their
quality of care through increased oversight. However, five of
the 12 Iowa homes that are either currently designated special-
focus facilities or are eligible for that designation based on
their poor performance, have maintained that status for at
least two years.
Nationally, the number of facilities on the list remains
relatively constant: There are normally about 88 nursing
facilities, with one or two slots to be filled by each State.
The Iowa Department of Inspections and Appeals nominates the
Iowa facilities for inclusion on the list, and CMS selects two
from the State to be enrolled in the program. In addition to
Iowa's two special-focus facilities, there are 10 Iowa homes
that qualify for inclusion on the list based on their poor
performance. In order for any of those 10 to be designated a
special-focus facility and receive the added regulatory
oversight that comes with it, one of the two currently
designated homes first must graduate from the list. Typically,
homes that are eligible for the
special-focus designation have about twice the average number
of violations cited by State inspectors; they have more serious
problems than most other nursing homes, including harm or
injury to residents; and they have established a pattern of
serious problems that has persisted over a long period of time.
My understanding is that the Nation's poorest performing nursing
homes are enrolled in the Department's ``special focus facilities
program,'' which is designed to help those facilities improve, and that
some of these poor performers will remain enrolled in the program for
years. It's also my understanding that other poorly performing nursing
homes may be eligible for the program, but cannot become a special
focus facility until another facility successfully completes the
program. The media also reported some time ago that a significant
number of the nursing homes that successfully emerge from the program
will later be cited for instances of serious harm to residents or for
placing residents in immediate jeopardy.
How many special focus facilities are there right now, how many of
those facilities have been enrolled in the program for more than a
year, and how many are eligible for inclusion in the program but are
not enrolled?
What can you tell me about this administration's plans, if any, to
improve the special focus facilities program?
Answer. Nursing homes' first obligation should be to their
residents, and every nursing home that participates in Medicare and
Medicaid must meet Federal health and safety standards. The Special
Focus Facility program was established to address facilities with
compliance history that have often not addressed the underlying
systemic problems that result in repeated cycles of serious
deficiencies. When a Special Focus Facility slot is open due to the
termination or graduation of a facility in the Special Focus Facility
program, the State agency must select a new facility from the candidate
list for the program supplied by CMS. The names of candidates are
issued monthly along with the Five-Star Quality Rating updates.
As of June 2021, there are currently 86 special focus facilities
and 51 of these facilities have been enrolled in the program for more
than a year. In addition, there are also 442 nursing homes considered
special focus facility candidates. This latest information is posted on
the CMS website at: https://www.cms.gov/Medicare/Provider-Enrollment-
and-Certification/CertificationandComplianc/Downloads/SFF
List.pdf. I am committed to working with you and your colleagues to
hold nursing homes accountable for providing high quality of care to
their residents.
Question. Access to emergency and primary health care services is a
basic quality of life issue for a resident of any sized community.
Section 125 of Public Law (Pub. L.) 116-260 established the Rural
Emergency Hospital (REH) voluntary Medicare payment designation. This
bipartisan solution will support struggling rural hospitals by allowing
them to voluntarily right-size their health-care infrastructure while
maintaining essential medical services for their rural communities. A
recent Government Accountability Office (GAO) report found more than
100 rural hospitals have closed in 28 different States since 2013. The
COVID-19 pandemic has only further strained rural hospital finances. If
nothing is done, more hospitals and rural Americans will continue
losing access to essential medical services resulting in poorer
outcomes and higher costs for patients and taxpayers. The REH
designation offers the flexibility to support rural hospitals that can
no longer support inpatient services while maintaining services that
better align with the specific needs of their patient population
including 24/7 emergency care, outpatient care, ambulance services, and
more. It is important that Federal regulations and guidance adequately
consider the needs of rural providers. Recently, Senator Klobuchar and
I sent a letter to the Centers for Medicare and Medicaid Services (CMS)
asking the agency to prioritize the implementation of this law by
establishing a project lead at CMS to ensure a timely and stakeholder-
driven implementation. In CMS' fiscal year 2022 budget justification it
stated, ``CMS will engage with stakeholders through the rulemaking
process in implementing this provision.''
Has CMS established a project lead at CMS to implement section 125
of Public Law (Pub. L.) 116-260?
If not, what is the timeline to establish a project lead or process
to implement section 125 of Public Law (Pub. L.) 116-260?
Answer. Section 125 of the Consolidated Appropriations Act (CAA) of
2021 requires that Rural Emergency Hospitals (REHs) be eligible for
Medicare payment for services furnished on or after January 1, 2023.
CMS continues to work diligently to ensure that the REH program is
fully implemented by the statutory date. CMS is coordinating with the
HHS Office of Rural Health Policy on the REH program and will be
issuing a request for information to better inform rulemaking. CMS
remains steadfast in its commitment to address the recent closures of
rural hospitals and ongoing access to health-care services in rural
communities and is focused on implementing the REH provision of the CAA
by the statutory deadline.
______
Questions Submitted by Hon. James Lankford
Question. On May 12, 2021, during a virtual hearing before members
of the House Energy and Commerce Committee, you repeatedly refused to
acknowledge that partial-birth abortions are illegal in the United
States, though they have been since 2003. My colleague, Senator Steve
Daines of Montana, asked you to clarify during the Finance hearing on
the FY 2022 budget. Unfortunately, you still refused to plainly State
that partial birth abortion is illegal. As such, please answer the
following questions, clearly, directly, and fully.
Do you agree that partial-birth abortion, as defined in 18 U.S.
Code Sec. 1531 is illegal and punishable by fine, imprisonment or both?
Do you agree with the Supreme Court decision to uphold the ban on
partial-birth abortions in Gonzales v. Carhart?
Do you agree that partial-birth abortions are a particularly
grotesque method of late-term abortions?
Will you commit, as Secretary of Health and Human Services, to
fully upholding and enforcing this law in conjunction with the
Department of Justice?
Answer. As stated during confirmation hearings, the Department will
follow all applicable laws as they relate to abortion and any other
issue.
Question. Current Federal law prevents funds from being used to pay
for abortions in most circumstances. Unfortunately, in the partisan
COVID response bill passed in March, my Democratic colleagues refused
to include the Hyde Amendment.
What specific steps you are taking to ensure that funds previously
enacted under FY21 appropriations and all of the COVID relief bills
that included Hyde restrictions are kept separate from all funding
passed under the American Rescue Plan?
Answer. As part of overall tracking of regular vs. emergency
appropriations, OMB directs agencies to separately track emergency
appropriations. HHS accomplishes that by fully segregating these funds
in its accounting records and grants systems.
Question. During the committee's hearing on the FY 2022 HHS budget,
and during your nomination hearing, I asked whether you intended to
maintain the Conscience and Religious Freedom Division within the
Office for Civil Rights. Your answers during both the nomination
hearing and FY 2022 budget hearings lacked clarity. As such, please
answer the following questions, clearly, directly and fully.
Will you commit to supporting and preserving the Conscience and
Religious Freedom Division's existing role, delegations, and
authorities in enforcing all conscience and religious freedom laws
applicable to HHS?
Will you respect the authority of the career professionals in the
Conscience and Religious Freedom Division to receive complaints,
investigate cases, and make findings independent of and without
interference or blocking from you or any personnel or political
appointees under you?
Will you commit to not dismantling, eliminating, or materially
diminishing the Conscience and Religious Freedom Division and to
prohibiting any personnel or political appointee under you from doing
the same?
Will you commit to not transferring, reassigning, or dismissing any
staff from the Conscience and Religious Freedom Division against their
will unless justified by bona fide and documented performance or
misconduct reasons?
Answer. As I stated during my hearing, HHS will continue to protect
the religious, civil, and constitutional rights of all Americans under
HHS's purview under our Office for Civil Rights. This means that we
will enforce conscience and religious freedom activities, including
receiving complaints, investigating cases, and making findings
consistent with the law.
Question. As you know, the previous administration disallowed $200
million in Medicaid funds from California because it was literally
forcing nuns to buy abortion insurance in violation of conscience
protection laws.
Will you commit to not reversing the findings made by career
professionals supporting the disallowance, and will you commit to not
restoring the money to California?
Answer. In my ethics agreement signed on January 17, 2021, and the
subsequent authorization issued on March 31, 2021, I have agreed not to
participate in any litigation involving the State of California that
was pending during my tenure as Attorney General. I understand that
there has been no litigation on this matter, however, as Attorney
General I did issue a public statement on the matter. After consulting
with the HHS Acting Designated Agency Ethics Official, I have
determined that it is prudent for me to recuse myself from this
Medicaid financing matter to avoid even an appearance of impropriety.
The U.S. Department of Health and Human Services (HHS) Office for
Civil Rights (OCR) completed a review of its January 24, 2020, Notice
of Violation (2020 NOV), against that the State of California and the
California Department of Managed Health Care (DMHC). On May 14, 2021,
CMS withdrew its January 15, 2021, Medicaid disallowance imposed on the
State due to an underlying finding of the State's ``continued non-
compliant status under the Weldon Amendment.'' As noted by CMS,
California's March 15, 2021, Request for Reconsideration of the
Medicaid disallowance raised issues related to OCR's underlying Weldon
violation determination; CMS thus referred the matter to OCR for
further review.
Having completed its review of the 2020 NOV, OCR withdrew its 2020
NOV and closed the complaints filed with OCR, on which the 2020 NOV was
based. More information on this matter can be found here: https://
www.hhs.gov/conscience/conscience-protections/ca-letter/index.html.
Question. During your nomination hearing, you acknowledged
potential conflicts of interest related to your activities as
California Attorney General, but did not provide the committee with an
explicit list of the relevant cases and matters to which you must be
recused.
As such, please list all cases and matters, including lawsuits,
amicus participation, investigations, administrative matters, regarding
which you have recused, or will recuse, yourself. Please include all
matters where you were a named respondent or were listed on the papers
and include full captions or titles, case, complaint, or matter
numbers, courts or agencies of jurisdiction and a full description of
the subject matter from which you will recuse yourself from in each
matter or case identified.
Answer. As Secretary, I provide leadership and direction for the
very talented employees of the Department who, at the working level,
handle the vast amounts of work, including specific litigation matters.
Pursuant to my ethics agreement signed on January 17, 2021, and the
subsequent authorization issued on March 31, 2021, I am not
participating in any litigation involving the State of California that
was pending during my tenure as Attorney General.
Question. A few weeks ago your agency announced, without going
through any sort of formal rule-making process, that HHS will interpret
prohibitions on sex discrimination in health care to include ``sexual
orientation and gender identity.''
Is it your intention to require doctors, hospitals, or medical
staff to participate in or perform gender transition procedures on any
patient, including a child, even if the doctor, hospital, or medical
staff believes the procedure would be harmful or it is against their
religious beliefs?
Will you protect the religious beliefs of doctors and medical staff
who object to participating in practices where they have a medical,
conscience or religious objection?
How does this interpretation impact the medical treatment of
patients in instances where biological sex is pertinent to treatment,
such as pregnancy and child birth?
Will you commit to ensuring taxpayer dollars are not used to fund
gender reassignment procedures, including puberty blockers and cross-
sex hormones on children?
Answer. As I stated during my hearing, HHS will continue to protect
the religious, civil, constitutional rights of all Americans under
HHS's purview under our Office for Civil Rights. This means that we
will enforce conscience and religious freedom activities, including
receiving complaints, investigating cases, and making findings
consistent with the law.
Question. While new purchases are being made by the administration
to send overseas, millions of Federal dollars invested in vaccine
development and distribution are being literally poured down the drain
due to States having more supply than demand.
What is the administration's plan to facilitate the redistribution
of vaccines currently in the hands of States before they expire?
Answer. FDA has continued to monitor the available data and has
announced shelf life extensions of COVID-19 vaccines numerous times.
HHS is also encouraging States to monitor their orders of vaccine and
utilize vaccines on hand prior to ordering additional doses.
Question. According to the fiscal year 2022 budget justification
estimate sent to Congress by HHS, pharmacy DIR fees increased by 91,500
percent between 2010 and 2019. This is unsustainable for community
pharmacies nationwide, many of whom serve underserved populations and
demands action by Congress and the administration. I recently
introduced bipartisan legislation with Senators Capito, Tester, and
Brown to address pharmacy DIR fees.
Can HHS provide us with more data to break down the yearly increase
of DIR fees so that we can better understand these dramatic increases
and their negative impact on small business pharmacies and the patients
they serve?
Moreover, are the cost increases over the last decade enough
justification for HHS to finalize reform of pharmacy DIR fees?
Answer. Given the significant growth in pharmacy price concessions
in recent years, when such amounts are not reflected in the negotiated
price, it has become increasingly difficult for consumers to know at
the point-of-sale what share, or approximate share, they are paying of
the plan's cost for their prescription drugs. I look forward to working
with Congress to improve transparency and competition in the Part D
program.
Question. I share your commitment to making prescription drugs
affordable for patients. Dating back to the Senate Finance drug pricing
markup in 2019, I have been working on policies that support
appropriate formulary placement of generics and biosimilars in Medicare
Part D. One of the key barriers to access to these affordable
medications is formulary design. I think this is a critical issue to
ensuring that generics and biosimilars are covered on Part D plans and
are included on the lower-cost sharing tiers so that beneficiaries
actually receive the benefit of these affordable medicines.
Last year, CMS finalized a policy to create a second specialty drug
tier with reduced cost-sharing for beneficiaries. This is an important
step forward, but more must be done to ensure newly approved generics
and biosimilars are added to lower-cost sharing tiers.
Will you commit to working with me on this issue to ensure Medicare
beneficiaries get access to these affordable medications and benefit
from the savings?
Answer. Prescription drug costs are too high for American patients
and families. From the meetings I have had with Senators, I have seen
that lowering drug prices is a priority on both sides of the aisle. I
agree that patient access to lower-cost generics and biosimilars is
important. Competition in the market has helped control the growth in
spending on prescription drugs, and generics and biosimilars certainly
have a role to play in creating competition for reference products. I
look forward to working with you and your colleagues to lower the cost
of prescription drugs.
______
Questions Submitted by Hon. Ben Sasse
Question. Two thousand, eight hundred providers in Nebraska have
received $873 million from the Provider Relief Fund, which many
providers continue to rely on to stabilize lost revenue from the early
days of the pandemic. I have heard from many who are grateful for last
week's announcement from the Health Resources and Services
Administration extending reporting timelines.
Could you share any information about where HHS is at on evaluating
the timing and formula for the remaining funds in the Phase 4
distribution?
Answer. HHS is working on approaches to distribute Provider Relief
Fund funding as quickly and equitably as possible while maintaining
effective safeguards for taxpayer dollars. HHS is considering feedback
from Congress and stakeholders, as well as operational lessons learned
from prior PRF payments, as part of this process. The Provider Relief
Fund also continues to make claims reimbursement to health-care
providers for COVID-19 testing, treatment, and vaccine administration
services for the uninsured, and COVID-19 vaccine administration for the
underinsured. Additional information on future distributions will be
published on HHS's Provider Relief Fund webpage, at www.hhs.gov/
providerrelief, as soon as it becomes available.
Question. At many points in last week's hearing you discussed the
administration's decision not to include the Hyde Amendment in the FY
2022 budget.
While we have already discussed our differences in opinion on this
decision, can you elaborate on the decision-making process that led to
this elimination and what data was used in that determination?
Answer. I am not in a position to share the pre-decisional
discussion with the Executive Office of the President.
Question. The FY 2022 budget calls for an increase in funding for
the National Institutes of Health, which I have supported in the past.
I am concerned, however, about the NIH's recent announcement that it
will no longer convene an Ethics Advisory Board to review research
applications seeking funding for projects which use human fetal tissue
and that projects using this tissue would resume without limitation.
These restrictions were put in place after serious ethical concerns
were brought to light, including one contract where researchers used
Federal funding to pay up to $2,000 for fully-intact infant bodies
aborted in the second trimester.
Without the Ethics Advisory Board, how will HHS determine whether
taxpayer dollars are being used for unethical or even illegal research
practices? Can you elaborate on this process?
Will you commit to working with Congress to ensure that the Ethics
Advisory Board is reinstated or that NIH policy governing research
using human fetal tissue is strengthened?
Answer. NIH's mission is to seek fundamental knowledge about the
nature and behavior of living systems and apply that knowledge to
enhance health, lengthen life, and reduce illness and disability. Under
its broad research mission, and as authorized by the Public Health
Service Act, NIH conducts and funds research involving the study,
analysis, or use of human fetal tissue for a range of diseases and
conditions. NIH also funds research to develop, demonstrate, and
validate experimental models that are alternatives to the use of human
fetal tissue.
On April 16, 2021, NIH published an Update on Changes to NIH
Requirements Regarding Proposed Human Fetal Tissue Research (NOT-OD-21-
111),\3\ stating that HHS was reversing its 2019 decision that all
research applications for NIH grants and contracts proposing the use of
human fetal tissue from elective abortions will be reviewed by an
Ethics Advisory Board. Accordingly, HHS/NIH will not convene another
NIH Human Fetal Tissue Research Ethics Advisory Board. Please note that
all other requirements described in NOT-OD-19-128 \4\ and updated in
NOT-OD-19-137 \5\ for extramural research remain unchanged.
Furthermore, NIH reminded the community of expectations to obtain
informed consent from the donor for any NIH-funded research using human
fetal tissue, and of continued obligations to conduct such research
only in accord with any applicable Federal, State, or local laws and
regulations, including prohibitions on the payment of valuable
consideration for such tissue.\6\ The same requirements apply to the
intramural program.
---------------------------------------------------------------------------
\3\ https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-
111.html.
\4\ https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-
128.html.
\5\ https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-
137.html.
\6\ https://grants.nih.gov/grants/guide/notice-files/not-od-16-
033.html.
All NIH-supported organizations certify that they will comply with
the NIH Grants Policy Statement,\7\ which summarizes NIH policies
regarding the use of human fetal tissue in research and incorporates
Federal statutory requirements for research with human fetal tissue
(sections 498A and 498B of the PHS Act, 42 U.S.C. 298g-1 and 298g-2).
---------------------------------------------------------------------------
\7\ grants.nih.gov/grants/policy/nihgps/HTML5/introduction.htm.
Question. On May 15, 2021, Politico reported that HHS took
approximately $2.13 billion in funding that Congress had primarily
appropriated for combating COVID-19 and redirected it to the crisis at
the southern border.\8\ These diverted funds included (1) $850 million
that was initially appropriated for rebuilding our Strategic National
Stockpile; (2) $850 million that was appropriated for expanding COVID-
19 testing; and (3) $436 million from ``a range of existing health
initiatives across the department.''\9\
---------------------------------------------------------------------------
\8\ Adam Cancryn, ``Biden administration reroutes billions in
emergency stockpile, COVID funds to border crunch,'' Politico (May 16,
2021), https://www.politico.com/news/2021/05/15/hhs-covid-stockpile-
money-border-migrants-488427.
\9\ Id.
On May 12, 2021, a few days before this news was released, you
testified before the House Energy and Commerce Committee's Subcommittee
on Health regarding HHS's budgetary needs for FY 2022. In this
testimony, you stated that HHS required $905 million for replenishing
the Strategic National Stockpile to ``ensure the stockpile is ready to
respond to future pandemic events and any other public health
threats.''\10\
---------------------------------------------------------------------------
\10\ The Fiscal Year 2022 HHS Budget Before the Subcommittee on
Health of the House Committee on Energy and Commerce, 117th Congress 2
(2021) (statement of Xavier Becerra, Secretary of Department of Health
and Human Services).
Did HHS divert $1.7 billion in COVID-19 testing and national
---------------------------------------------------------------------------
stockpile funds to assist the crisis at the southern border?
Answer. All HHS actions were carried out under explicit authority
provided by the Congress. For example, the discretionary COVID
supplementary appropriations included explicit authority to transfer
funds as necessary among certain Operating Divisions of HHS to cover
costs incurred as a result of COVID-19.
Question. If yes, how will these funds be replenished moving
forward?
Answer. The American Rescue Plan Act of 2021 provided $6.05 billion
for research, development, manufacturing, production, and the purchase
of vaccines, therapeutics, and ancillary medical products and supplies
to prevent, prepare, or respond to COVID-19 or any disease with
pandemic potential. Of this amount, $850 million was allocated to the
SNS to procure supplies to respond to the COVID-19 pandemic.
Question. Are the current resources in the Strategic National
Stockpile sufficient to meet our PPE and medical supply needs?
Answer. Using supplemental funding, the Strategic National
Stockpile has vastly increased its inventory of PPE, ancillary medical
supplies, pharmaceuticals, and ventilators to meet the national demand.
Funds continue to increase production capacity of PPE and other medical
supplies and treatments for acquisition into the Stockpile and to
support product distributions to impacted States.
Question. Was the $905-million budget request for the Strategic
National Stockpile calculated before or after the $850 million in
existing funds for the stockpile were repurposed to assist with the
crisis at the southern border?
Answer. The budget includes $905 million for the SNS to make
meaningful investments across a number of portfolios necessary to
ensure readiness for future public health emergencies. Funds would also
be used to support SNS's ongoing storage and distribution needs, which
were expanded and modified to meet the demands of the COVID-19
pandemic. These activities are separate from on-going COVID response
activities which have largely been supported by supplemental
appropriations.
Question. The budget also requests $3.3 billion for the
Unaccompanied Children Program, a $2-billion increase, or more than
double the previous amount.
Is the program currently housing more than double the number of
children as it was previously?
Answer. The Unaccompanied Children (UC) Program received an
unprecedented number of children in the spring of 2021. On April 28,
2021, ORR reported a census of nearly 23,000 children in care, and
migration trends continue to drive an increase in resource needs in
this program. The UC Program receives funding from Congress that is
available to obligate over a 3-year period, allowing unused funds in 1
year to be carried over and obligated in the next 2 years. About $1.3
billion was carried over from FY 2020 into FY 2021, primarily due to
the availability of 2019 supplemental appropriations during FY 2020.
While the budget is requesting a $2 billion increase in appropriations,
the budget also shows that year to year spending is expected to
increase from $2 billion in FY 2020 to $3 billion in FY 2021 and to
$3.5 billion in FY 2022. (See printed page 63, or pdf page 68 of the FY
2022 budget request: https://www.acf.hhs.gov/sites/default/files/
documents/olab/fy_2022_con
gressional_justification.pdf.)
Question. What is the current number of children in HHS custody?
Answer. As of June 10, 2021, there are 16,487 children either
physically resident in ORR programs or en route to ORR custody from
CBP.
Question. Will these funds be used to support the children without
a sponsor who end up in the U.S. foster care system?
Answer. No. Funds are not used to transfer unaccompanied children
into the U.S. domestic foster care system. While ORR long-term foster
care families are licensed by the State to serve as foster families,
and must adhere to State licensing regulations, ORR long-term foster
care programs are not State-funded and are not part of the State child
welfare system. Please see ORR Policy 3.6 ORR Long-Term Foster Care for
additional information. Further, the funding request is not related to
the ORR unaccompanied refugee minor (URM) program, which serves several
eligible populations including paroled unaccompanied Afghan minors.
______
Questions Submitted by Hon. Benjamin L. Cardin
Question. Currently, Medicare has a statutory exclusion on Medicare
coverage of dental care and routine dental services like x-rays and
cleanings. For the two-thirds of elderly beneficiaries and individuals
with disabilities under Medicare, this means their access to care is
incomplete.
Establishing a Medicare dental benefit has been a priority of mine
for a number of years, and earlier this year I introduced legislation
again, along with Senators Brown and Casey, that would create a dental
benefit under Part B to improve the health of our Medicare
beneficiaries. Recently, I and a number of my colleagues, including
Senators Stabenow and Sanders, wrote to President Biden urging that
Medicare benefits be expanded to include dental care. I am also pleased
that the President Biden's budget supports strengthening Medicare by
improving access to dental, hearing, and vision coverage for
beneficiaries.
What are the administration's next steps to establish a dental
benefit in Medicare?
Answer. Thank you for your leadership on this important issue. Oral
health is a critical part of overall health and I look forward to
working with you on these issues. President Biden supports making
dental coverage a standard benefit in Medicare. I know this is an
important issue to you, and I look forward to working with you on the
legislation needed to expand access to dental care in Medicare.
Question. I am glad the FY 2022 budget proposes $100 million for
the CDC to establish a new Community Violence Intervention (CVI)
initiative, in collaboration with DOJ, to support evidence-based
community violence interventions at the local level. Hospital-based
interventions are among the most effective within this category.
By providing services for victims of violent crime while they are
recovering from their injuries, these programs equip survivors to make
lifestyle changes that prevent them from being re-victimized and reduce
their likelihood of being involved in future violence. The program at
the University of Maryland Medical Center's Shock Trauma Center has
demonstrated impressive results. However, there are few Federal
resources available for this work.
I will introduce legislation, the End Cycle of Violence Act, which
would create HHS grants for hospital-based violence intervention or
prevention programs. The bill would use Federal funds to establish or
expand operations and study their effectiveness. The House of
Representatives last month passed a companion bill, introduced by my
colleague Congressman Ruppersberger, with strong bipartisan support.
Could you speak about the administration's decision to start this
new Community Violence Intervention Initiative?
Answer. The proposed Community Violence Intervention Initiative is
an opportunity to help create safe communities by meeting communities
where they are based on the needs and priorities they identify and
assisting them with the implementation of proven prevention strategies
that have been shown to reduce serious and lethal violence, arrests,
aggression, substance use, and other behavioral risks.
The additional $100 million in the President's Budget request will
be dedicated to a new evidence-based community violence intervention
initiative. CDC will support implementation of evidence-based and
innovative evidence-informed violence prevention strategies with the
greatest potential in communities most impacted by community violence
in four ways:
1. CDC will support implementation of evidence-based violence
prevention strategies with the greatest potential in the 25 cities with
the highest overall number of homicides and the 25 cities with the
highest number of homicides per capita.
2. Beyond the five National Centers of Excellence in Youth
Violence Prevention that CDC currently funds, CDC will fund an
additional 24 research awards using all available funding mechanisms to
further build the evidence base for preventing violence in those
communities experiencing the greatest burden of youth and community
violence, and to reduce the racial, ethnic, and economic inequities
that characterize such violence across our country.
3. Supporting up to five non-governmental organizations that have
expertise in partnering with communities most impacted by community
violence.
4. Modernize data systems to enhance the ability of States,
cities, and communities to monitor youth and community violence in real
time. This will include improvements to the National Violent Death
Reporting System.
Question. In light of estimates that gun violence costs taxpayers
billions of dollars annually, can you comment on the potential returns
on these investments?
Answer. Community violence interventions have a large potential for
return on investment. There are multiple sources for substantial
savings, including direct reductions in law enforcement costs, as well
as prosecution, corrections, medical, counseling, and employee
productivity costs, to less direct benefits for the educational system,
local business, and property values. These benefits are in addition to
reductions in the pain and suffering to victims, their families, and
friends. Studies to quantify returns on investment from violence
prevention strategies vary widely in their approaches but generally
find that the benefits outweigh the costs.
Question. In establishing new Federal funding sources for these
programs, why is it important to leave room for local flexibility?
Answer. Hospital-based violence prevention programs are a promising
strategy to reduce repeat and future risk of firearm victimization and
perpetration. By strengthening the connections between the acute
treatment of violence-related injuries and community services and
supports, these approaches help lessen trauma, increase situational
awareness and skills, and reduce co-occurring behavioral and social
risks. Tailoring a program to the local context helps ensure success.
These types of approaches produce better results when they can draw
upon credible messengers from the local community with training and/or
lived experience, when there is administrative support and resources
within the hospital to support the program, and when there are strong
partnerships between hospitals and organizations in the community
offering a wide array of services and supports to address the needs of
clients. Leaving room for local flexibility is important as it guards
against a one-size fits all approach which would be inconsistent with
the aims of these programs.
______
Questions Submitted by Hon. Michael F. Bennet
Question. Thank you for your, and Deputy HHS Secretary Palm's,
commitment to working with me to help support rural communities in
Colorado, including through regulatory and financial relief for rural
hospitals and providers. I also appreciate the funding for community
health and hospital resilience infrastructure in the FY 2022 budget
request. I am concerned that there was not specific funding for rural
hospital and provider infrastructure.
Can you explain how you intend to specifically support rural
hospitals' infrastructure needs, like that of Lincoln Health, in Hugo,
CO--which represents the only access to acute care services within a
70-mile radius, yet does not have private rooms and showering
facilities--through the FY 2022 HHS budget?
Answer. The Hospital Preparedness Program (HPP) supports efforts to
strengthen health-care sector readiness to provide coordinated, life-
saving care in the face of emergencies and disasters. The HPP portfolio
supports a comprehensive, national network for health-care preparedness
and response. The programs and activities within the HPP portfolio are
coordinated to address the many, complex facets of the Nation's health-
care system, creating mechanisms and infrastructure to improve
coordination between localities, States, and regions, as well as
developing new capabilities (e.g., telemedicine, specialty health care,
etc.) specific to key challenges within the modern threat landscape
(e.g., highly pathogenic disease, biological/chemical incidents, etc.).
As the primary source of Federal funding for health-care system
preparedness and response, HPP promotes a consistent national focus to
improve patient outcomes during emergencies and to enable rapid health-
care service resilience and recovery. Since 2002, investments
administered through HPP have improved individual health-care entities'
preparedness and have built a system for coordinated health-care system
readiness and response through health-care coalitions (HCCs) and other
partnerships, such as the Regional Disaster Health Response System
(RDHRS) demonstration project. With respect to infrastructure needs,
recipients of funding are expected to consider how to provide and plan
for uninterrupted care when faced with damaged or disabled health-care
infrastructure during an emergency response; however, the HPP
cooperative agreement does not allow for construction or major
renovation costs.
HPP provides cooperative agreement funding to States to support
health-care system preparedness efforts. Specific to Colorado, if
appropriated at the requested level in Fiscal Year 2022, it is
estimated that Colorado will receive $3,584,461 via the HPP cooperative
agreement. Colorado will delegate this funding within the State to
support such efforts, including enhancing rural capabilities.
Additional ASPR Programs and Tools Concerning Colorado and Rural
Health:
The Denver Health and Hospital Authority was also recently
awarded the Partnership for Disaster Health Response System Cooperative
Agreement to establish the Region 8 Mountain Plains RDHRS demonstration
site. To address gaps in regional health-care delivery during
disasters, ASPR developed the RDHRS: a tiered system that builds upon
and unifies existing health-care and ASPR assets within States and
across regions that supports a more coherent, comprehensive, and
capable health-care disaster response system able to respond to health
security threats. The RDHRS helps improve disaster readiness
capabilities and capacity, increase medical surge capacity, and extend
provision specialty care--including trauma, burn and infectious
disease, among others--during large-scale disasters or public health
emergencies.
Additionally, the Rural Health Care Surge Readiness Portal was
established in 2020 to provide the most up-to-date and critical
resources for rural health-care systems preparing for and responding to
a COVID-19 surge. The resources span a wide range of health-care
settings (including EMS, inpatient and hospital care, ambulatory care,
and long-term care) and cover a broad array of topics ranging from
behavioral health to health-care operations to telehealth. This portal
was developed by the COVID-19 Healthcare Resilience Working Group, a
partnership with the Department of Health NS Human Services, the
Department of Homeland Security, and other Federal agencies, to provide
support and guidance for health-care delivery and workforce capacity
and protection.
Question. I am also concerned with the revised reporting
requirements for the Provider Relief Fund (PRF) released by HHS on June
11, 2021. I appreciate the Department granting more flexibility to
providers who received funds after June 30, 2020, and the extension of
reporting requirement deadlines. However, the revised guidance fails to
address the concerns of providers we have heard from who received PRF
funds prior to June 30, and who will be required to repay those funds
if not utilized by June 20, 2021.
While the country is certainly making strides towards ending this
pandemic, it is not over. I have heard from rural providers across
Colorado who are still struggling to get back on their feet, and for
whom this crisis will continue long past June of this year. By leaving
in place the repayment requirement for unused funds, providers
(including rural hospitals, rural health clinics, and Federally
Qualified Health Centers) will have to repay the money intended to help
them navigate this once in a century pandemic, even when cases in
certain rural counties are rising.
The Department, June 16, 2021, has stated that, ``HRSA will not be
providing alterations to the [repayment] policy at this point.''
Can you explain how the FY 2022 HHS budget ensures that rural
hospitals, who may need these funds to support needs related to COVID-
19, will provide the hardest hit hospitals in Colorado with the support
they need?
Would you work with HRSA to amend this policy, especially for
rural hospitals and providers, who might need the regulatory and
financial relief that we talked about prior to your confirmation?
Answer. Please note that PRF recipients may use payments for
eligible expenses or lost revenues incurred prior to receipt of those
payments (i.e., pre-award costs) so long as the funds are to prevent,
prepare for, and respond to coronavirus. It is the obligation (or
incurred) date that determines whether the expense is an allowable
cost, not the date of possession. If the purchase occurred within the
period of availability, but the item was received after the period of
availability, it would still be considered an allowable cost. The
provider will need to maintain adequate supporting documentation to
show that the expense is attributable to coronavirus and was incurred
within the period of availability. Providers must retain supporting
documentation for 3 years.
HHS has also hosted webinars to provide technical assistance to
providers. The recordings are made available online at https://
www.hhs.gov/coronavirus/cares-act-provider-relief-fund/reporting-
auditing/index.html. We also encourage providers to contact the
provider support line--HHS will now provide second tier technical
assistance for providers and will communicate directly with them to
walk through their questions. The number is (866) 569-3522; for TTY
dial 711. Hours of operation are 7 a.m. to 10 p.m. Central Time, Monday
through Friday.
Question. Over the past year, I have been working with Senator Todd
Young on a proposal to address the issue of antimicrobial resistance.
According to the CDC, each year in the U.S., at least 2.8 million
people suffer from an antibiotic-resistant infection, and more than
35,000 people die--many of these are Medicare beneficiaries. Over the
course of the past year, secondary infections from COVID-19
hospitalizations and other types of infections in nursing homes became
a concern. In my mind, there are a few issues: the first is
stewardship--underusing or overusing antibiotics inappropriately. The
second is the lack of antibiotic development for drugs that treat
resistance infections. According to the World Bank, this could reduce
the global economy by trillions of dollars in less than a decade.
That is why Senator Young and I are working on the PASTEUR Act.
This legislation creates a new model on how to pay for novel
antibiotics for Americans who receive their health insurance through
Federal health programs. I am glad that the budget increases funding
for development of antibiotics, but, due to market failures and broken
reimbursement system, many of those companies receive FDA approval and
then have to shut down. I understand this was economic incentives for
antibiotic development was an important topic at the Group of Seven
Health Ministers meeting a few weeks ago.
Can you explain your commitment to address antimicrobial resistance
through economic incentives for development, including the model
proposed in the PASTEUR Act, and why this was not reflected in the FY
2022 budget?
Answer. Thank you for your leadership in this area. The increase in
serious antimicrobial drug resistant infections is a significant public
health threat. It jeopardizes many areas of progress in modern
medicine, such as cancer treatment, organ transplantation, and other
surgical procedures that are often associated with microbial infection
complications--and leaves some patients with few or no good treatment
options. Antimicrobial stewardship efforts can help slow the
development of new resistance and aggressive containment efforts can
help stem its spread. However, new antimicrobials are and will continue
to be needed to treat infections caused by resistant bacteria and
fungi.
Congress passed legislation as a part of the Food and Drug
Administration Safety and Innovation Act (FDASIA) and the 21st Century
Cures Act to incentivize antimicrobial development, facilitate
development of drugs for the most difficult to study infections, and
streamline the updating of breakpoints in antimicrobial labeling. Real
advances have occurred as a result of these initiatives. Unfortunately,
reports suggest companies focused on antimicrobial drug development are
struggling economically even after the approval of a new antibacterial
drug. The emerging consensus is that a multifaceted approach towards
antimicrobial drug development is needed, including incentives large
enough to overcome the economic realities of developing and marketing a
new antimicrobial drug.
The PASTEUR Act seeks to incentivize development of antimicrobial
products by establishing an antimicrobial subscription model to
encourage the development of innovative antimicrobial drugs and address
the economic issues that companies have grappled with in the
antibacterial space after approval by creating a guaranteed
reimbursement level for certain antimicrobial drugs. We are happy to
continue working with you on this important legislation.
______
Question Submitted by Hon. John Thune
Question. In Fall 2019, HHS published a report on strategies for IT
modernization for the Indian Health Service. This report included a lot
of key work that was projected to occur in 2020 and 2021. This budget
proposes to increase funding for updating IHS's electronic health
record system, which will be a key part of IT modernization.
Is the Department's strategic plan for modernization still on
track, or should we anticipate delays in progress due to the pandemic?
Answer. The 2019 Health IT Modernization Research Project informed
the Department of Health and Human Services (HHS) and Indian Health
Service (IHS) efforts to modernize the IHS Health Information
Technology (HIT) system. The research project identified estimated
timelines and approaches to HIT modernization. The final report
identified risks and challenges for IHS regarding recurring funding for
Health IT, (IHS HIT Final Report, pg. 15, pg. 26).
In 2020, IHS implemented the Project Management Office, released
the 2015 ONC Certified Edition of RPMS, and tested interoperability
with the VA. Additionally, IHS addressed COVID-19 testing surveillance
and vaccine reporting as part of the pandemic response.
IHS is currently developing the acquisition plan and will realign
the timeline estimates based on the completed planning, listening
sessions, and industry engagement. IHS does not expect significant
delays in the Project due to the COVID-19 response.
______
Questions Submitted by Hon. Catherine Cortez Masto
Question. Earlier this year I sent a letter to you and Secretary
Cardona asking about how HHS and the Department of Education plan on
working together to equip schools to address kids' mental health needs.
I appreciate the handful of examples in your response where your
agencies are collaborating, and I encourage you to continue working
closely with Ed to support students' mental health and well-being.
What will the administration deem as success in addressing kids'
mental health needs?
Answer. In deeming success in addressing kids' mental health needs,
HHS will prioritize having children and youth feel safe in their homes,
their schools, and their communities. In addition, the administration
will make investments so that children and youth receive mental health
literacy and prevention services through an integrated social emotional
learning curriculum within their school. Through the administration's
policies to expand access to health care, children and youth who need
clinical intervention will have access to community or school based
mental health services. Lastly, children and youth who need intensive
intervention, should receive intensive services so that they are able
to remain with family and thereby reducing the need for foster care,
inpatient, residential (juvenile justice and/or psychiatric)
placements.
Question. The end-of-year package that Congress passed in December
included 1,000 new graduate medical education slots to address
physician shortages across the country. The law directed HHS to focus
new slots in rural and underserved areas, but left the Secretary with
significant discretion in distributing slots.
What are the parameters that the administration will apply in
distributing those slots?
Answer. HHS is working hard to implement new laws increasing
medical residency positions in hospitals in rural and underserved
communities to address workforce shortages. Encouraging more health
professionals to work in rural hospitals and underserved areas, and the
need to retain and train high-quality physicians to help address access
to health care in these communities, is critically important.
In the fiscal year 2022 proposed rule (CMS-1752-P) for payment to
inpatient and long-term care hospitals just released in April, CMS is
proposing to implement provisions of the Consolidated Appropriations
Act (CAA) that relate to Graduate Medical Education (GME). CMS is
proposing to distribute the slots to qualifying hospitals, as specified
by the law, including those located in rural areas and those serving
areas with a shortage of health-care professionals.
Question. Nevada's Governor Sisolak signed into law legislation to
create the Nation's second-ever public option after Washington State.
That bill is the product of a lot of hard work by Nevada legislators
and advocates, Nevada's new coverage option will be made available to
people beginning in 2026, with implementation taking place in the
interim. And my State will be seeking a Federal 1332 innovation waiver
to enable us to provide more affordable coverage to Nevadans.
Can I get your commitment to work with me and my State on the
successful implementation of this new law?
Answer. President Biden has made it very clear that his goals for
improving the American health-care system begin with building on the
successes of the Affordable Care Act. HHS is committed to working in
partnership with States on policies that affect health insurance
coverage in their States, including through applications for section
1332 State innovation waivers.
______
Questions Submitted by Hon. Sherrod Brown
Question. As noted in the President's FY 2022 budget proposal,
pharmacy DIR fees increased by more than 91,000 percent between 2010
and 2019. I continue to hear from pharmacists across Ohio about the
challenges these fees create for small businesses and the patients they
serve; the status quo is unsustainable for community pharmacies in Ohio
and nationwide.
Recently, I partnered with Senators Tester, Lankford, and Capito to
introduce bipartisan legislation to address this issue. Our legislation
would increase transparency and create a standardized set of pharmacy
performance/quality metrics to improve quality of care.
Does HHS have additional information on the increase in DIR fees
that could help illuminate the changing trends in Medicare Part D? If
so, please provide additional detail and any available data breaking
down the yearly increase in DIR fees, including the impact the increase
in fees has had on community pharmacies and the patients they serve.
Will you commit to working with myself, and Senators Tester,
Lankford, Capito, and others, to reform DIR in Medicare Part D by
increasing transparency, establishing standardized quality metrics, and
providing community pharmacies with more predictability so they can
better serve Medicare beneficiaries?
Answer. Given the significant growth in pharmacy price concessions
in recent years, when such amounts are not reflected in the negotiated
price, it has become increasingly difficult for consumers to know at
the point-of-sale what share, or approximate share, they are paying of
the plan's costs for their prescription drugs. I look forward to
working with Congress to improve transparency and competition in the
Part D program.
Question. Pediatric patients are underrepresented in clinical
trials and do not experience the same level of positive health outcomes
associated with clinical research advancement. Among pediatric
patients, the rate of clinical trial enrollment drops at the age of 15.
Unsurprisingly, adolescents--with the lowest enrollment in cancer
clinical trials--gain the least in terms of improvements to survival
rates. Additionally, approximately 50 percent of all medicines used in
children do not have FDA-approved labeling for pediatric patients.
During clinical trials for COVID-19 vaccine candidates, trials in
adolescent and pediatric populations enrolled participants less quickly
displaying the lack of priority, investment, and infrastructure to
conduct studies in this population.
The President's budget reflects strong investment in medical
research--how will you ensure Americans of all ages are able to
participate and therefore benefit from medical research and clinical
trials?
Senator Wicker and I sent a letter to the National Institutes of
Health in March 2021 requesting information and a meeting on this
issue, and we have yet to receive a response. What specific steps will
you take to ensure expanding access to clinical trials to
underrepresented populations, including adolescents and children,
remains a priority for this administration?
Answer. NIH received the letter from Senators Brown and Wicker and
will respond soon. The information presented here also may be found in
that response.
NIH is and remains committed to supporting clinical research that
benefits individuals of all ages. Current plans to achieve that goal
are focused on ensuring successful implementation of the NIH Inclusion
Across the Lifespan Policy by engaging the scientific community;
providing internal and external training, guidance, and communications;
and ensuring NIH systems allow for collection and publication of data
on participant age to help us better understand the distribution of
participants in NIH clinical research.
NIH's Inclusion Across the Lifespan Policy \11\ became effective in
January 2019 and ensures that individuals are included in clinical
research in a manner appropriate to the scientific question under
study, so that the knowledge gained from NIH-funded research is
applicable to all those affected by the researched diseases/conditions.
The policy expanded the Inclusion of Children in Clinical Research
Policy to require that all human subjects' research conducted or
supported by the NIH includes individuals of all ages unless there are
scientific, legal, regulatory, or ethical reasons to not include them.
The policy also requires that the age of each participant at the time
of enrollment be collected in progress reports.
---------------------------------------------------------------------------
\11\ https://grants.nih.gov/policy/inclusion/lifespan.htm.
In FY 2021, NIH began receiving data on participant age at
enrollment for the applications submitted under the Inclusion Across
the Lifespan Policy (for those applications submitted in 2019, awarded
in FY 2020, and reporting progress in FY 2021). NIH continues efforts
to enhance NIH systems to support submission, monitoring, and reporting
---------------------------------------------------------------------------
of these data.
Several NIH-wide initiatives are working to identify opportunities
for the inclusion of pediatric participants in research while
prioritizing the most promising science. In September 2020, NIH held
its second Inclusion Across the Lifespan Workshop \12\ to examine the
State of the science, discuss lessons learned, and share evidence-based
practical advice to consider going forward. NIH issued a Request for
Information to gather public input on potential topics for the
workshop, which included discussions of inclusion and exclusion
criteria; study design and metrics; recruitment, enrollment, and
retention; and data analysis and study interpretation. The full
workshop report details are published on an NIH website \13\ and
summarized in the NIH Deputy Director for Extramural Research's ``Open
Mike'' blog.\14\
---------------------------------------------------------------------------
\12\ https://www.nia.nih.gov/Inclusion-Across-Lifespan-2020.
\13\ https://grants.nih.gov/sites/default/files/IAL-II-Workshop-
Report.pdf.
\14\ https://nexus.od.nih.gov/all/2020/12/10/some-thoughts-
following-the-nih-inclusion-across-the-lifespan-2-workshop/.
The need to provide training and resources to researchers was among
the common themes discussed at the Inclusion Across the Lifespan II
workshop. In the fall of 2020, NIH held an NIH Virtual Seminar, with
more than 13,000 attendees. The Seminar included several events focused
on inclusion across the lifespan: a session on ``Including Diverse
Populations in NIH-funded Clinical Research;'' an ``Ask the NIH
Inclusion Policy Officer'' virtual discussion; a booth with resources
for investigators on Human Subjects, Clinical Trials, and Inclusion;
and opportunities for one-on-one discussions with NIH staff. NIH plans
---------------------------------------------------------------------------
to host another NIH Virtual Seminar from November 1-4, 2021.
Question. Due to a decade of CMS oversight, hospital-based nursing
schools across the country--10 of which are located in Ohio--are being
made aware of overpayments they received up to a decade ago that they
may be required to repay over the next year or so. Some have already
been contacted to reopen closed cost reports to claw back Federal funds
that were allocated and spent years ago. Hospital-based nursing schools
are already in crisis as a result of the COVID-19 pandemic, and now
they are being asked to repay the money they received due to no fault
of their own. If left unaddressed, this could result in closure or
scaling back of hospital-based nursing schools and other training
programs leaving fewer nurses and educational opportunities.
Will you work with my office on solutions to help prevent these
clawbacks and help preserve our hospital-based nursing schools through
the public health and financial crisis brought on by the COVID-19
pandemic?
Answer. Encouraging more health professionals to work in hospital-
based nursing schools and underserved areas, and the need to retain and
train high-quality health professionals to help address access to
health care in these communities, is critically important. These
institutions are critical to our Nation's health-care system and have
been especially important during the pandemic. I look forward to
working with you on this important issue.
Question. I appreciate the President's FY 2022 commitment to
maintaining funding for the Healthy Start program, which helps support
community-based strategies to reduce disparities in infant mortality
and improve perinatal outcomes for women and children in high-risk
areas. Ohio is home to five healthy start sites, which have helped
combat our State's significant infant mortality problem.
Are there lessons learned from the success of the Healthy Start
program that could help inform strategies to address disparities in
maternal mortality?
Answer. Healthy Start funding supports community-based
interventions that address some of the most vulnerable populations of
women, children, and families by providing a range of services
associated with improving maternal and infant health outcomes. These
services incorporate: (1) referrals and ongoing health-care
coordination for well-woman, prenatal, postpartum, and well-child care;
(2) case management and linkage to social services; (3) alcohol,
tobacco, and other drug use counseling; (4) nutritional counseling and
breastfeeding support; (5) perinatal depression screening and linkage
to behavioral health services; (6) inter-conception education and
reproductive life planning; and (7) child development education and
parenting support.
In FY 2019, Healthy Start began supporting a new initiative to
reduce maternal mortality through hiring of clinical service providers
(e.g., nurse practitioners, certified nurse midwives, physician
assistants, and other maternal-child advance practice health
professionals) to provide clinical services, such as well-woman care
and maternity care services, within program sites nationwide. In FYs
2020 and 2021, HRSA used $15 million to support these activities within
existing Healthy Start grants. To date, 92 grantees have received
clinician funding and hired 173 providers. Between November 2019 and
October 2020, there were 18,540 visits at participating sites.
The FY 2022 budget request of $128.0 million continues to include
$15 million to allow grantees to hire clinical service providers at
Healthy Start sites to provide direct access to well woman care and
maternity care services. In FY 2022, the program will continue to serve
women and families across the Nation through the 101 grants awarded in
the FY 2019 funding cycle. HHS looks forward to incorporating lessons
learned as we continue to strategize on ways to achieve health equity
and improve maternal health outcomes for racial and ethnic minorities.
Question. What specific actions is HHS taking to help strengthen
coverage and access to high-quality, comprehensive care for pregnant
and postpartum individuals to reduce infant mortality rates and address
disparities in outcomes?
I have legislation--the Healthy MOM Act--that would establish a
special enrollment period once an individual becomes pregnant. Would
you work with me on ways to strengthen coverage options for pregnant
women, including this idea?
Answer. Healthy Start programs have impacted families and
communities across the United States through a reduction in infant
mortality rates, increasing access to early prenatal care, and removing
barriers to health-care access. Close collaboration with local, State,
regional, and national partners is key to Healthy Start's success.
HHS recently approved multiple States' requests to test the effects
of providing full Medicaid benefits to women for 12 months postpartum,
significantly expanding coverage from the current 60-day postpartum
period. Importantly, the American Rescue Plan provides an easier
pathway for States to extend Medicaid postpartum coverage from 60 days
to 12 months, and CMS expects to provide additional guidance to States
on these provisions in the coming months. HHS also announced a Notice
of Funding Opportunity (NOFO) that will make $12 million available over
four years for the Rural Maternity and Obstetrics Management Strategies
(RMOMS) program that will allow awardees to test models to address
unmet needs for their target population. For the first time, applicants
are required to focus on populations that have historically suffered
from poorer health outcomes, health disparities, and other inequities.
I will continue to work tirelessly to reduce maternal and infant
mortality and morbidity, using the expertise and resources across the
many HHS agencies whose missions include ensuring maternal health. I am
committed to working with Congress, and with State and local partners
to make sure that we are improving maternal health; my team is happy to
work with you on the Healthy MOM Act and other ways to strengthen
coverage options for pregnant women.
Question. Thank you for your commitment to continuing efforts to
address youth smoking and e-cigarettes, and for the FY 2022 budget
proposal's commitment to preventing a new generation of children from
becoming addicted to nicotine through e-cigarettes. I look forward to
working with you to ensure this issue remains a top priority moving
forward. As your budget acknowledges, e-cigarette use among youth
increased by 78 percent among high school students and by 48 percent
among middle school students from 2017 to 2018. While the 2020 National
Youth Tobacco Survey showed a decline in youth e-cig use, youth use
remains a public health crisis that demands urgent action. Given the
fact that we do not yet have a confirmed Commissioner of the Food and
Drug Administration, I ask for your commitment to ensure we do not fall
behind on our efforts to address youth e-cig and tobacco use.
Can you please confirm that the FDA will meet the September 9, 2021
deadline to order the immediate removal of all deemed tobacco products,
including electronic nicotine delivery system components or parts, that
do not meet the criteria in 21 U.S.C. 387j to be appropriate for the
protection of public health and have not received a tobacco product
marketing order? What specific steps will you take to ensure the FDA
meets this deadline?
Answer. All new tobacco products on the market without the
statutorily required premarket authorization are marketed unlawfully
and are subject to enforcement at FDA's discretion. FDA's highest
enforcement priorities include products for which no application is
pending, including (for example) those with a Marketing Denial Order
and those for which no application was submitted.
As of June 10, 2021, FDA has received thousands of tobacco product
submissions covering millions of tobacco products, the vast majority of
which are for ENDS products. FDA has completed initial processing of
all timely submitted PMTAs--more than 6.5 million products submitted by
over 550 companies--and acceptance, filing, and substantive scientific
review of the applications is underway.
Due to the large number of applications moving into review at the
same time, the novelty of this review, the finite nature of our review
resources, and the necessarily rate-limiting effects of ensuring
consistency across reviews, FDA developed a process to determine the
review order for the applications. For PMTAs, the review order for most
of the products is determined using a computer-generated randomization
process. However, due to the large number of ENDS products currently
marketed and for which we received applications, FDA decided to
dedicate a portion of its resources to reviewing the products that
account for the vast majority of the current market.
The continued marketing of these widely used products has the
potential to have the greatest public health impact--either positively
or negatively--as they hold the largest overall market share and
therefore are likely used by the largest number of people. For this
reason, FDA pulled several applications into a separate review queue
and dedicated resources to their review. By identifying and ensuring
review of these applications, we believe we can achieve the greatest
public health impact most quickly. If FDA finds that a currently
marketed product is not appropriate for the protection of public
health--the standard in the law for marketing a new tobacco product
that is the subject of a PMTA--the agency will issue a No Marketing
Order (NMO) and the product must be removed from the market.
Conversely, if FDA finds that a currently marketed product does meet
the standard in the law for marketing, the agency will grant a
marketing order and the product may remain on the market subject to the
conditions in the order. In either case, earlier review of a currently
marketed product ensures a faster transition to a marketplace of
products that have been scientifically reviewed for their impact on
public health.
We are working to review applications as quickly as possible.
However, given the unprecedented number of applications and other
factors discussed above, reviewing all the applications by September 9,
2021, will be challenging. We will continue to allocate our resources
with the goal of working as quickly as possible to transition the
current marketplace for deemed products to one in which all new tobacco
products available for sale have undergone a careful, science-based
review by FDA. We will focus resources on products where scientific
review will have the greatest public health impact, including with
respect to youth use of ENDS products, based on their market share,
while also reviewing as many applications as possible from all
companies regardless of size, prior to September 9, 2021, at which time
they risk FDA enforcement.
FDA has commenced substantive scientific review on over a thousand
products submitted through the PMTA pathway. The agency continues to
review tobacco product applications through all applicable premarket
pathways and provide updates on its progress through FDA's Tobacco
Product Applications: Metrics and Reporting webpage.
Question. Will you commit to applying the appropriate for the
protection of the public health (APPH) standard for all new tobacco
products to ensure that no marketing orders are issued for any
product--including any liquid, solution, or other component part--that
contains a flavor unless the manufacturer has demonstrated that the
characterizing flavor: will increase the likelihood of smoking
cessation among current users of tobacco products; will not increase
the likelihood of youth initiation of nicotine or tobacco products; and
will not increase the likelihood of harm to the person using the
characterizing flavor?
Answer. Yes, I assure you that FDA will commit to applying the
appropriate standard for the public health standard.
Question. On April 29, 2021, the FDA announced that it would commit
to advancing a tobacco product standard to ban menthol as a
characterizing flavor in cigarettes. This step is long overdue.
Will you ensure the FDA moves forward quickly to finalize
rulemaking to set product standards that ban menthol in cigarettes and
cigars in order to protect public health and address racial and ethnic
health disparities?
Answer. On April 29, 2021, FDA announced its commitment to issue
two tobacco product standards: one to prohibit all characterizing
flavors, including menthol, in cigars; and a second to prohibit menthol
as a characterizing flavor in cigarettes. FDA aims to and remains on
track to issue both proposed rules by the end of April 2022.
Question. As you know, the CDC is currently working to update and
replace two NIOSH facilities in Cincinnati, OH. On May 12, 2021 the CDC
and GSA presented its schematic design for the new campus to local
stakeholders in Cincinnati; the proposal was met with a lot of
enthusiasm from the local community and interested parties are eager
for the project to move forward.
This project is not just about updating the NIOSH buildings--this
is about improving government efficiency and creating jobs in Southwest
Ohio. Last year you committed to continuing to move this project
forward. I again ask for your commitment to making this project a
priority for the administration and keeping this project on schedule,
despite the FY 2021 budget's proposed cuts to CDC.
Question. Has the CDC finalized its purchase of the properties
necessary to move forward with this project? If not, please provide an
update on the purchase timeline.
Answer. At this time, CDC has completed due diligence efforts such
as environmental assessments, appraisals, title searches, boundary
surveys, and cost negotiations. In addition, CDC has submitted
necessary title evidence to the Department of Justice (DOJ). Once an
acceptable preliminary title opinion is received from DOJ, CDC will
immediately move forward with formal closing on the property. The
estimated closing for the University of Cincinnati Foundation Holdings
owned parcels is August 2021 with the City of Cincinnati owned parcels
expected to close in December 2021.
Question. Please share an update on the timeline for the NIOSH site
consolidation and construction project in Cincinnati, Ohio. Do you
expect the completion of construction and occupancy of the facility by
NIOSH staff to take place by Summer 2024?
Answer. The architectural and engineering design is well underway
with an anticipated completion in December 2021. CDC will move forward
with the Construction phase in Summer 2022 with an anticipated
occupancy date of Fall 2024.
Question. I understand that the CDC anticipates awarding a contract
for the project to a General Contractor in late 2021. Please elaborate
on the resources HHS plans to spend on this project in FY22 to ensure
it continues to move forward according to plan.
Answer. Due to the extended property acquisition schedule
identified in the response above, CDC anticipates the award of the
construction phase in Summer 2022. In addition, CDC has assigned
senior-level staff to this project to ensure it continues on-schedule
to be completed in Fall 2024.
Question. Will you commit to working with Senator Portman and me to
keep this project moving forward under your leadership at HHS?
Answer. CDC remains committed to construction and development of
the Consolidated Cincinnati Research Facility. As the project continues
to accelerate, HHS is committed to working with you and Sen. Portman to
keep this project moving forward.
TB was the world's most deadly infectious disease until November
2020, now second only to COVID-19, and still ranking ahead of HIV/AIDS,
killing 1.4 million people annually. In the United States, TB remains a
serious problem with all 50 States continuing to report cases annually.
According to CDC, there were an estimated 7,163 new cases of TB
reported in the United States during 2020. The pandemic severely
impacted TB case notifications due to TB program staff being reassigned
to work on COVID-19 and patients being unable or unwilling to seek
testing and care under stay-at-home orders and similar policies.
The President's FY 2022 budget proposal states that the ``CDC
envisions a future free of . . . tuberculosis.''
Question. How will the proposed increase in funding for the CDC's
HIV/AIDS, Viral Hepatitis, Sexually Transmitted Infection and
Tuberculosis Prevention program help move us closer to the stated goal
of eliminating TB, and ensure the CDC is able to continue to make
progress toward eliminating TB in America?
Answer. CDC's domestic TB program drives TB elimination strategy in
the United States and globally. State, local, and international TB
programs depend on CDC for innovations that bring us closer to TB
elimination.
Through CDC's Tuberculosis Trials Consortium (TBTC), CDC supports
vital, unparalleled epidemiologic research and clinical trials that
have significantly impacted TB treatment. In FY 2022, CDC's newly
recompeted TBTC will continue to focus on improving treatment for TB
disease, particularly among children and people living with HIV/AIDS.
Additionally, in FY 2022 CDC will continue to support 50 States,
eight large cities, Washington, DC, and two territories to conduct TB
surveillance and oversee the medical and public health management of
persons with TB and their contacts. CDC will also continue to fund four
TB Centers of Excellence to provide training and technical assistance
for contact tracing, outreach, and case management, TB educational
materials, and medical consultation for health-care professionals
treating TB patients, particularly those with complex or drug-resistant
cases. CDC will offer state-of-the-art TB laboratory services to health
departments, free of charge. To expand targeted testing and treatment
for LTBI, CDC will continue to work with health departments,
professional associations, and other groups to explore ways to test
people who are currently unable to receive preventive TB services
through health departments.
Question. What are the CDC's plans to prioritize its global TB
efforts and sustain partner countries' efforts in addressing TB
globally?
Answer. CDC is on the frontlines in more than 25 countries working
with partner governments to find, cure, and prevent TB and sustain and
enhance global public health systems; CDC is also working with partners
to improve case-finding approaches and optimize use of diagnostics. CDC
collaborates with countries and the World Health Organization (WHO) to
conduct TB prevalence and drug resistance surveys to document the
global burden of disease. Data from these surveys allows countries to
target health interventions. CDC also focuses on optimizing TB and
multidrug-resistant TB treatment regimens, improving linkages to care
and treatment, improving treatment adherence and cure rates among
patients with drug-
resistant TB, and assessing costs and barriers to care. CDC is also
scaling up laboratory external quality assurance systems and training,
strengthening surveillance systems to improve TB and MDR-TB burden
estimates, improving track program performance, and training ministry
of health and national TB program staff. Additionally, CDC provides
laboratory technical assistance to partner countries through the
agency's Reference Lab to ensure the efficiency of diagnostic networks
and accuracy of laboratory and point of care testing. Working in tandem
with PEPFAR, CDC supports TB screening for people living with HIV and
leads in the PEPFAR effort to ensure people living with HIV have access
to latent TB treatment, significantly reducing the chance they will
become ill with TB.
Question. Under current law, Medicare covers short-term, inpatient,
respite care services for hospice patients if their primary caregiver
needs a break. Medicare will cover up to 5 days of respite care if the
hospice beneficiary's primary caregiver is ill, needs rest, or is
otherwise unable to care for the hospice patient at that time. However,
respite care may only be provided in an inpatient facility, such as a
hospital, hospice facility, or nursing home, and the benefit is limited
to just five days at a time.
The existing limitations on Medicare's hospice respite benefit have
made it difficult for family caregivers to utilize this important
benefit during the COVID-19 pandemic. Some families are reluctant to
utilize the respite benefit because doing so would mean moving their
loved one into a congregate living facility--such as a hospital or
nursing home--where there may be a greater risk of contracting the
virus. Additionally, some caregivers may need more than 5 days of
respite care if they believe they have been exposed to COVID-19 and
need to isolate for 2 weeks. COVID-19 has demonstrated to us the
importance of providing hospice patients and families much needed
respite care in various settings, including in their communities and
homes or wherever they may call home.
Senator Capito and I have introduced the COVID-19 Hospice Respite
Relief Act to strengthen Medicare respite care for some of our most
vulnerable Americans. Our legislation would allow the Secretary of HHS
to make the hospice respite care benefit more flexible during any
public health emergency, helping to meet the needs of both hospice
patients and their caregivers by: increasing the number of days a
patient can receive respite care from 5 days to 15 days; and making the
hospice respite benefit available to hospice patients in their place of
residence as an alternative to an inpatient setting.
While I understand that there may be existing flexibility under
hospice's routine home care benefit to provide respite care in the
home, I have heard concerns from community providers that the routine
homecare rate may not be sufficient to cover the care necessary to
truly provide respite care. In addition, patients are capped at 5 days
of care.
Will you work with Senator Capito and I to ensure access to
meaningful respite care for all those who need it by exploring existing
regulatory authority options and by working with us on legislative
solutions, if necessary?
Answer. Building on lessons learned during COVID-19, I look forward
to working with you to make sure hospice patients and their caregivers
can receive respite care services. As someone whose father passed away
at home, ensuring that patient choices are respected, including the
ability to receive care at home, is of utmost importance.
Question. Section 108 of the No Surprises Act, which passed into
law as part of H.R. 133, the Consolidated Appropriations Act of 2021,
contains a provision that requires HHS, along with the Departments of
Labor and Treasury, to promulgate rules on provider nondiscrimination.
My office has heard from stakeholders who are anxious to see this
section of law implemented.
Recognizing that this rulemaking may be a joint effort between HHS,
DOL, and Treasury, please provide a proposed timeline for
implementation of section 108.
Will HHS, DOL, or Treasury be taking the lead on this rulemaking?
Please provide an update on any efforts already underway at HHS to
promulgate this rulemaking.
Will you commit to finalizing the rule under this section this
year?
Answer. HHS is working collaboratively with the Departments of
Labor and the Treasury to ensure that the No Surprises Act, including
section 108, is implemented in a timely and effective manner.
Question. As you know, States are set to implement services under
the Family First Act by October 1st of this year.
Please describe how the Department's FY 2022 budget will ensure
States, including county-administered child welfare systems like Ohio,
can effectively implement the law?
Answer. Two of the important provisions of the Family First
Prevention Services Act (FFPSA) (as part of Public Law 115-123) were
provisions placing limitations on title IV-E foster care payments for
children placed in non-family-based foster care settings (i.e., child
care institutions) and the creation of the title IV-E Prevention
Services Program. FFPSA allowed a title IV-E agency to request a delay
of up to 2 years (until October 1, 2021) for the provisions of the law
limiting Federal financial participation for placements that are not in
foster family homes. Title IV-E agencies choosing to take a delay in
the provisions relating to foster care were required to delay
participation in the title IV-E Prevention Services for the same
period. Ten States and five tribes chose not to delay implementation of
these provisions. Most title IV-E agencies (36 of 53 States and
territories operating title IV-E, and six of 11 tribes directly
operating the title IV-E program) chose to take the maximum delay of 2
years to implement these provisions. The remaining 7 States requested
to delay for a period of less than 2 years. While participation in the
title IV-E Prevention Services Program is optional, many States and
tribes are actively working toward implementation. To date, 34 States,
the District of Columbia, and four tribal jurisdictions have submitted
Prevention Plans. Of those, 17 State plans (Utah, Maine, Maryland,
Arkansas, Kansas, Kentucky, North Dakota, West Virginia, Virginia,
Washington, Nebraska, Iowa, Ohio, Oklahoma, Oregon, Hawaii, and
Illinois), the District of Columbia plan, and one tribal IV-E plan
(Eastern Band of Cherokee Indians (North Carolina)) have received
approval.
The HHS FY 2022 budget provides increased resources to support the
capacity of the title IV-E Prevention Services Clearinghouse to conduct
its reviews of prevention programs, as well as technical assistance and
evaluation activities to expand the availability of rated programs and
practices for the title IV-E Prevention Services Program.
On behalf of the Children's Bureau, the Capacity Building Center
for States (the Center) assists State and territorial child welfare
agencies, including those that have county-administered systems, build
capacity to better serve youth and families by undertaking training and
technical assistance activities and promoting best practices in child
welfare such as those related to implementation of the requirements of
the Family First Prevention Services Act. The Child Welfare Information
Gateway (Information Gateway) develops, disseminates, and maintains
publications, website pages, general information, and guidance on a
variety of child welfare topics, including those supporting
implementation of the requirements of the FFPSA.
The Center provides customized support to jurisdictions in
developing more
prevention-oriented systems and leveraging the transformational
opportunities in the FFPSA to right-size residential care, address race
equity in child welfare, explore and implement evidence-based programs,
and shift resources to better support healthy families. In
collaboration with the State (and counties as appropriate) and the
Children's Bureau, the Center assists States in implementing FFPSA.
In addition to providing direct services to jurisdictions, the
Center facilitates peer-to-peer connections via peer groups. Two
groups, Transformational Child Welfare Leaders and Family First
Prevention Plan Leads directly support implementing FFPSA and moving
toward a prevention-oriented system. An additional peer group, County-
Administered State Partnership Peer Group, promotes collaboration and
problem solving among peers from county-administered State child
welfare programs.
Finally, Information Gateway and the Center develop tools,
resources, and products to build knowledge and support practice and
have prioritized publications supporting implementation of FFPSA.
Information Gateway is currently developing a web section to provide
information related to FFPSA.
______
Prepared Statement of Hon. Mike Crapo,
a U.S. Senator From Idaho
Thank you, Mr. Chairman. The events of the past year have
emphasized the importance of the Department of Health and Human
Services.
Last year, the efforts of HHS and its sub-agencies ensured safe
access to crucial health-care services, even at the height of the
pandemic, through telehealth expansion and other emergency
flexibilities. HHS also proved pivotal in partnering with private-
sector innovators to help bring several safe and effective COVID-19
vaccines to the public in record time.
In the months ahead, the administration should work with Congress
to build on these successes, as well as to address some of the
challenges the past year has created or exacerbated. Certain aspects of
the President's budget request seem aligned with these aims. The
proposal describes a concerted effort to build on our program integrity
efforts to tackle waste, fraud, and abuse, which harm taxpayers,
patients, and families. Program integrity represents a clear area of
common ground.
The budget request also highlights the importance of value-based
care, which will prove indispensable as we work to lower health-care
costs while increasing care quality. Unfortunately, other aspects of
the President's proposal raise serious questions and concerns.
Medicare trust fund solvency remains a pressing crisis,
jeopardizing benefits for tens of millions of seniors, and yet this
budget request proposes no meaningful policies to contain unsustainable
spending growth. In fact, apart from outlining trillions of dollars in
tax increases and spending hikes, the budget proposal offers few policy
details at all. Much of the blueprint focuses on vague references to
agenda items, with no meaningful discussion of how to pay for them.
These policies stray substantially from the promise of unity and
bipartisanship initially advertised by this administration. Proposals
to lower the Medicare eligibility age, for example, would likely crowd
out private coverage without moving the needle on access or
affordability--all on the American taxpayer's dime. The budget request
also suggests using Medicare dollars to expand Obamacare, just as we
saw with the original passage of the ACA more than a decade ago.
Rather than champion the market-based reforms that have made
Medicare Advantage and Part D such resounding success stories for our
Nation's seniors, the budget proposes a convoluted price control scheme
for prescription drugs that would reduce access to lifesaving cures in
the years ahead. For the roughly four in 10 seniors enrolled in
Medicare Advantage plans, the policies referenced in the budget request
could also mean drastic cuts, which could jeopardize supplemental
benefits like dental and vision. The document also affirms
prioritization of $400 billion to increase access to home and
community-based services.
Home and community-based services are a key lifeline for scores of
Americans, and Congress should consider bipartisan policies to expand
availability. This should include ensuring States have the workforce
necessary to meet demand.
Unfortunately, media reports suggest this $400 billion may be used
to establish certain labor reforms that fail to address the gaps in
patient services States have experienced for decades. That being said,
I am confident we can find areas of common ground, and I look forward
to working with you, Mr. Chairman, to advance
consensus-driven policies on a range of health-care issues, from
telehealth to value-based care.
Mr. Secretary, it is good to see you again. I look forward to your
testimony and to discussing these and other vitally important issues
with you today.
______
Prepared Statement of Hon. Ron Wyden,
a U.S. Senator From Oregon
This morning the Finance Committee welcomes Secretary Becerra to
discuss the president's 2022 budget proposal for the Department of
Health and Human Services. There's a lot to talk about this morning.
I'm going to begin with out-of-control drug prices.
Far too many Americans are getting clobbered with every trip to
pick up their medications at the pharmacy window. The latest drug
pricing news is the approval of Aduhelm, a new medication for
Alzheimer's disease--one of the chronic diseases that now define
Medicare in the modern day. The drug's approval was controversial.
There is little data showing it actually does what the company says it
will do. Despite that, Aduhelm has an unconscionable list price of
$56,000 per year. Let's understand, it is not a cure, like some other
recent breakthrough drugs have been. Patients could be on Aduhelm for
years at a time after their diagnosis, multiplying the overall cost of
treatment.
Setting aside the lack of clear evidence that this new Alzheimer's
drug actually works, medical science today is capable of miracles. The
speedy development of highly effective coronavirus vaccines is one
example. Everybody in this room welcomes and cheers those advances.
However, Americans are terrified by the status quo on drug pricing. Not
only are too many Americans forgoing or rationing their prescriptions,
sky-high drug prices could bust our health-care budgets.
I'm working to update the Finance Committee's prescription drug
legislation from the last Congress, and I welcome the ideas of all
members of the committee. I believe it's long past time to give
Medicare the authority to negotiate better prices for prescription
drugs on behalf of more than 50 million seniors. Overwhelmingly, the
American people support that idea. President Biden, during his joint
session speech in April, called on the Congress to get it done.
We are all hungry for genuine medical breakthroughs, but what does
it mean, Senators, if the vast majority of Americans cannot afford
them?
A few other issues related to the budget proposal and the
administration's HHS priorities. It's very welcome to see proposals on
mental health, because mental health care is a major priority for this
committee. We'll have a lot more to say on mental health during our
Finance Committee hearing on the topic next week.
As I've discussed with Secretary Becerra, I look forward to
continuing to work with his team on further implementation of the
CHRONIC Care Act, specifically expanding its benefits to those
receiving traditional Medicare. That way, the law Congress passed back
in 2018 will continue to update the Medicare guarantee.
I'm also pleased that the administration is going to continue
making progress on the issue of transparency and sunlight with respect
to health-care prices. It's important to make sure that progress is
useful to consumers as part of an overall effort to make health care
more affordable.
The budget includes a proposal for a landmark investment of $400
billion to expand access to home and community-based services through
Medicaid. This would be an absolute game-changer resulting in more
choices and better care for millions of seniors and people with
disabilities.
Senator Casey and I, along with a lot of other members on this
committee, are working nights and weekends to get this done. We're also
interested in building up the care workforce to make sure these changes
deliver on their huge potential.
On the subject of helping the most vulnerable Americans out there,
I'll close on child welfare. A few years ago this committee passed
legislation called the Family First Act to help more families stay
together safely instead of relying on foster care. One of our key goals
was to get more help to black and Native American families, whose kids
are disproportionately represented in the child welfare system.
However, the Trump administration gave short shrift to the
implementation of this law, and it is not living up to its promise for
a lot of those vulnerable youngsters.
The Biden administration has an opportunity to change that. It is
also proposing a new grant program that ought to help address racial
disparities in the foster care system. I'm looking forward to working
with Secretary Becerra on these issues. There are a lot of kids and
families who will benefit from it.
______
Communication
----------
Center for Fiscal Equity
14448 Parkvale Road, Suite 6
Rockville, MD 20853
[email protected]
Statement of Michael G. Bindner
Chairman Wyden and Ranking Member Crapo, thank you for the opportunity
to submit these comments for the record on the HHS FY 2022 Budget
Request. 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 and end protections for pre-existing
conditions and mandates. The public option would then cover all
families who are rejected for either pre-existing conditions or the
inability to pay. In essence, this is an expansion of Medicaid to
everyone with a pre-existing condition. As such, it would be funded
through increased taxation, which will be addressed below. A variation
is the expansion of the Uniformed Public Health Service to treat such
individuals and their families.
The public option is inherently unstable over the long term. The profit
motive will ultimately make the exclusion pool grow until private
insurance would no longer be justified, leading-again to Single Payer
if the race to cut customers leads to no one left in private insurance
who is actually sick. This eventually becomes Medicare for All, but
with easier passage and sudden adoption as private health plans are
either banned or become bankrupt. Single-payer would then be what
occurs when insurance companies are bailed out in bankruptcy, the
public option covers everyone and insurance companies are limited to
administering the government program on a state by state basis.
The financing of the Affordable Care Act should be broadened. It should
neither be funded by the wealthy or by loan sharking student loan
debtors. Instead, it should be funded by an employer-paid consumption
tax, with partial offsets to tax payments for employer provided
insurance and taxes actually collected funding a Public Option (which
should also replace Medicaid for non-retirees). Medicaid for retirees
and Medicare should be funded by a border adjustable goods and services
tax, which should be broad based.
Why the difference? The goal is to not need a public option as
employers do the right thing and cover every worker or potential
worker. Using an employer based tax is an incentive to maximize
employee coverage. Medicare, however, is an obligation on society as a
whole.
Our comments on Social Security administrative and capital costs
originated in our testimony to the Appropriations Subcommittee.
I submitted our testimony as an SSDI beneficiary, as well as for
retirees. Even before the pandemic, my SSDI was inadequate for food,
medicine, clothing and cable. If I owned a vehicle, there is no way I
could maintain it or even buy gas. I have an above average benefit,
high enough to be ineligible for SNAP or Medicaid. Many are not so
lucky, even on a good day.
In the last few months, days have not been so good. Were it not for
stimulus payments, I would be running out of food as I write this and
would not have just bought new clothes, from socks and underwear to a
jacket I can wear when the Committee finally asks me to testify in
person. As it is, I will need to use the last $600 from my December
payment (which should have come through Social Security) to attend my
upcoming high school reunion. Whale I have wifi, I cannot afford cable
and a car is still out of reach.
Let me underline a point. In most months, new underwear is not an
option, I rely on free bus rides due to the pandemic and subsidies from
Ride On and there is never enough money in that last week before the
check comes. When it does arrive, the cupboard is bare.
Food prices are skyrocketing. Part of the problem may be too much money
chasing too few goods, but retirees and the disabled find (our)selves
between a rock and a hard place. We need a COLA and we need it now.
Most of us cannot even afford cola. Because this is a short term
emergency due to the Pandemic, it should be funded out of the general
fund until the normal process kicks in for next year.
This brings us to the funding of Social Security administrative costs.
They are low--the most efficient in retirement savings. However, they
should not have any. This is especially the case responding to the
pandemic.
Use general revenues now to fund administration, improvements and more
office space. As the pandemic wanes, caution will still be necessary
for a while. It is time to build out some infrastructure in both
government and leased space. The same is the case for Medicare and
Disability Insurance costs.
The general fund already owes trillions of dollars to the Social
Security Trust Fund. Rather than trying to figure out how to extend the
fund for a 75 year balance at the expense of future retirees, fund n0n-
benefit costs immediately from the general fund.
State governments are under financial pressure as a result of the
pandemic, especially in the area of healthcare costs, most especially
for seniors in nursing homes who are ``dual eligibles.'' The heart of
President Reagan's 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.
For long term balance, any cuts must be avoided. Indeed, they are dead
on arrival. In the long-term, as we have stated recently as well, debt
will be a problem--but not within the next few years--as neither Europe
nor China will enact the same kind of consolidated income tax, debt and
monetary reserve system that allows us to be the world's currency
securitization provider.
Debt reduction must not be an excuse to cut entitlements. As we state
in our debt volume, Squaring and Setting Accounts: Who Really Owns the
National Debt? Who Owes It?--December 2019, the debt assets owed to the
bottom 40% are sacrosanct, as they paid for it with regressive payroll
taxes while they were working or by having to shift from the Civil
Service Retirement System to the Federal Employee Retirement System
which required savings rather than a defined benefit.
Forty years ago, the decision was made to advance-fund the retirement
of the baby boomers, rather than immediately begin subsidies from the
general fund. Doing so would have required repealing the tax cuts for
the rich enacted by President Reagan, the Senate and just enough
conservative Democrats in the House to do damage.
Now that the wealthy have to pay what they owe to the trust fund (or
rather, the children of the wealthy of the 80s), people are talking
about means-testing Social Security and were talking about making it
attractive to upper classes by investing it. The latter nonsense died
in 2008. The former would again make asset holders fix the debt
liability of the top 10%. It would also rob the bottom two quintiles of
their most effective voice--higher income taxpayers who do receive
benefits. As long as they get them, the program is safe.
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.
[all]