[Senate Hearing 116-486]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 116-486
                     PRESIDENT'S FISCAL YEAR 2021 
                         HEALTH CARE PROPOSALS

=======================================================================

                                HEARING

                               BEFORE THE

                          COMMITTEE ON FINANCE
                          UNITED STATES SENATE

                     ONE HUNDRED SIXTEENTH CONGRESS

                             SECOND SESSION
                               __________

                           FEBRUARY 13, 2020
                               __________

                                     
                  [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
                  
                                                                      
            Printed for the use of the Committee on Finance
            
                             ___________

                    U.S. GOVERNMENT PUBLISHING OFFICE
                    
45-465-PDF                WASHINGTON : 2021   





                          COMMITTEE ON FINANCE

                     CHUCK GRASSLEY, Iowa, Chairman

MIKE CRAPO, Idaho                    RON WYDEN, Oregon
PAT ROBERTS, Kansas                  DEBBIE STABENOW, Michigan
MICHAEL B. ENZI, Wyoming             MARIA CANTWELL, Washington
JOHN CORNYN, Texas                   ROBERT MENENDEZ, New Jersey
JOHN THUNE, South Dakota             THOMAS R. CARPER, Delaware
RICHARD BURR, North Carolina         BENJAMIN L. CARDIN, Maryland
ROB PORTMAN, Ohio                    SHERROD BROWN, Ohio
PATRICK J. TOOMEY, Pennsylvania      MICHAEL F. BENNET, Colorado
TIM SCOTT, South Carolina            ROBERT P. CASEY, Jr., Pennsylvania
BILL CASSIDY, Louisiana              MARK R. WARNER, Virginia
JAMES LANKFORD, Oklahoma             SHELDON WHITEHOUSE, Rhode Island
STEVE DAINES, Montana                MAGGIE HASSAN, New Hampshire
TODD YOUNG, Indiana                  CATHERINE CORTEZ MASTO, Nevada
BEN SASSE, Nebraska

             Kolan Davis, Staff Director and Chief Counsel

              Joshua Sheinkman, Democratic Staff Director

                                  (ii)


                            C O N T E N T S

                              ----------                              

                           OPENING STATEMENTS

                                                                   Page
Grassley, Hon. Chuck, a U.S. Senator from Iowa, chairman, 
  Committee on Finance...........................................     1
Wyden, Hon. Ron, a U.S. Senator from Oregon......................     3

                         ADMINISTRATION WITNESS

Azar, Hon. Alex M., II, Secretary, Department of Health and Human 
  Services, Washington, DC.......................................     5

               ALPHABETICAL LISTING AND APPENDIX MATERIAL

Azar, Hon. Alex M., II:
    Testimony....................................................     5
    Prepared statement...........................................    45
    Responses to questions from committee members................    56
Grassley, Hon. Chuck:
    Opening statement............................................     1
    Prepared statement...........................................   126
Wyden, Hon. Ron:
    Opening statement............................................     3
    Prepared statement...........................................   126

                             Communications

American Academy of Audiology....................................   129
American Speech-Language-Hearing Association.....................   131
Center for Fiscal Equity.........................................   136
Health Industry Distributors Association.........................   141

                                 (iii)

 
                     PRESIDENT'S FISCAL YEAR 2021 
                         HEALTH CARE PROPOSALS

                              ----------                              


                      THURSDAY, FEBRUARY 13, 2020

                                       U.S. Senate,
                                      Committee on Finance,
                                                    Washington, DC.
    The hearing was convened, pursuant to notice, at 9:30 a.m., 
in Room SD-215, Dirksen Senate Office Building, Hon. Chuck 
Grassley (chairman of the committee) presiding.
    Present: Senators Crapo, Roberts, Enzi, Cornyn, Thune, 
Burr, Portman, Toomey, Scott, Cassidy, Lankford, Daines, Young, 
Sasse, Wyden, Stabenow, Cantwell, Menendez, Carper, Cardin, 
Brown, Bennet, Casey, Warner, Whitehouse, Hassan, and Cortez 
Masto.
    Also present: Republican staff: Brett Baker, Chief Health 
Policy Director; Erin Dempsey, Deputy Health Policy Director; 
Evelyn Fortier, General Counsel for Health and Chief of Special 
Projects; Ryan Martin, Senior Human Services Advisor; Stuart 
Portman, Health Policy Advisor; and Jeffrey Wrase, Deputy Staff 
Director and Chief Economist. Democratic staff: Anne Dwyer, 
Senior Health Counsel; Michael Evans, Deputy Staff Director and 
Chief Counsel; Elizabeth Jurinka, Chief Health Advisor; Kristen 
Lunde, Health Policy Advisor; Joshua Sheinkman, Staff Director; 
Beth Vrable, Deputy Chief Counsel and Senior Health Counsel; 
and Arielle Woronoff, Senior Health Counsel.

 OPENING STATEMENT OF HON. CHUCK GRASSLEY, A U.S. SENATOR FROM 
              IOWA, CHAIRMAN, COMMITTEE ON FINANCE

    The Chairman. Good morning, everybody. I think before I 
give my statement--we have several votes at 10:30, and I think 
we have worked it out with Senator Wyden and other people that 
we will keep this meeting going. So I am going to leave at 
10:30 and vote once and then come back--and I think the first 
vote always takes a long time. And then when Senator Wyden gets 
back--no, then he will--in other words, for the second and 
third votes I am going to stay over there and do them together. 
You know how it works out. I may not explain it very well. 
[Laughter.]
    I want to welcome our witness, our Secretary of Health and 
Human Services, the Honorable Alex Azar. I appreciate, 
Secretary Azar, your appearing before the committee to discuss 
the budget, the new budget.
    Secretary Azar oversees a very sprawling department with 
programs that are crucial to the health and well-being of many 
Americans, and maybe you would say all Americans. The budget 
represents the administration's recommended funding for those 
programs, as well as key policy proposals.
    While Congress decides funding levels and program changes, 
we have a duty, of course, to review the administration's 
budget proposal. And Secretary Azar is here to help us do that.
    As with any budget submission, I disagree with some of the 
proposals, but I do want to speak to a few issues where it 
reflects priorities that I have. And a lot of these priorities 
are shared by a lot of Democrats, and particularly with Senator 
Wyden. So as I mentioned, Senator Wyden's and my working to 
lower prescription drug prices is a very top priority.
    President Trump's focus on this issue has been a real game 
changer, particularly because, in the State of the Union 
message, he has brought attention to that.
    Secretary Azar has been a point person in this effort as 
well. The Secretary has also helped greatly with our 
legislative effort, again referring to prescription drugs, 
because your team, as well as you, have provided guidance and 
technical assistance as we developed and refined the bipartisan 
bill the committee reported out 19 to 9 in July of last year.
    I am pleased that the budget calls on Congress to quickly 
pass a bipartisan bill and includes a prescription drug place-
holder for $135 billion in reduced taxpayer subsidy to drug 
companies. I will ask the Secretary to expand on this when we 
have questions. For now, I will say that I look forward to 
continuing to work with the Secretary, the ranking member, and 
other Senators to provide relief on prescription drugs to these 
consumers.
    The budget also contains a number of proposals to improve 
health care in rural communities. Ensuring access to health 
care in Iowa and other rural areas has long been a priority for 
me, but also for most of the members of this committee. It has 
not really been a controversial issue in most cases. The 
ranking member and I continue to discuss how to help rural and 
other under-served areas. The administration's budget further 
bolsters those efforts.
    I would like to also take a moment to highlight efforts to 
help HHS be more effective in executing its mission. I 
understand that HHS's Office of National Security is forging 
new ground with the intelligence community to leverage 
technology in innovative ways to better streamline intelligence 
operation procedures and to mitigate counterintelligence 
threats.
    I encourage the intelligence community to provide even 
broader access to the Office of National Security as it relates 
to its products and database, and to then allow HHS to access 
vital information that it needs to mitigate threats to the 
Department, its funded partners, and its interagency 
colleagues.
    As you are aware, via my oversight efforts I have worked to 
make sure that the Office of National Security receives access 
to certain intelligence community-related material, and that 
you have gained access to some but not all that you want. 
However, more work needs to be done then.
    Recently I sent two classified letters to the intelligence 
community components to help bridge the gap between the Office 
of National Security and the IC counterparts. As I have said 
before, the left hand and right hand work together for the 
taxpayers. As we have found out, 9/11 may not have happened if 
we had had more cooperation between the intelligence people and 
the FBI, as one example. Now of course, hopefully that is 
better, but I will bet it is not as good as it should be.
    I will conclude by noting that HHS has many important 
challenges. Some are longstanding, like the high cost of 
prescription drugs; others appear with little notice, such as 
the novel coronavirus. While there are sure to be disagreements 
on many items in the budget, the issues I have highlighted are 
a reminder that we can work together in a bipartisan way to get 
things done for the American people.
    [The prepared statement of Chairman Grassley appears in the 
appendix.]
    The Chairman. Senator Wyden?

             OPENING STATEMENT OF HON. RON WYDEN, 
                   A U.S. SENATOR FROM OREGON

    Senator Wyden. Thank you very much, Mr. Chairman. I 
appreciate your scheduling this so quickly, and I appreciate 
your working with me on a host of issues.
    Mr. Secretary, we appreciate your being here, and that you 
are willing to come right after the budget comes out while 
these issues are ones we will all face when we are on our way 
home tonight and over the next week.
    President Trump's health-care agenda, in my view, rips 
scores of new holes in the safety net that vulnerable Americans 
are sure to fall through. And the textbook example is Medicaid. 
Right now the administration is trying to do, on its own, what 
it failed to get through Congress: block-grant Medicaid. It is 
a policy, colleagues, we debated in this very room back in 
September 2017. It did not make it out of the committee. It did 
not get a vote on the floor. It did not go anywhere because it 
is really horrible policy--horrible policy that would hurt our 
people.
    That said, the Trump administration does not seem to mind. 
Now it is trying to pull an administrative end-run around the 
Congress to push the dirty work of Medicaid block grants onto 
the States.
    You hear a whole lot of Washington lingo now about 
flexibility. They even gave it a name that goes into the George 
Orwell Hall of Infamy. It is called ``Healthy Adult 
Opportunity.'' Let us make no mistake. The Trump administration 
proposal to block-grant Medicaid, led by CMS Administrator 
Seema Verma, in my view would be the beginning of the end for 
the health-care safety net.
    It is not about flexibility. It is certainly not about 
opportunity for healthy adults. It is about harsh, Draconian 
cuts. And it comes in addition to the other cuts the Trump 
administration has proposed for Medicaid. So I am going to take 
just a minute--and I see my good friend Bob Casey, who is so 
eloquent on this subject--and talk about what Medicaid really 
means for the American people.
    Medicaid pays for two out of three nursing home beds in 
this country. That is because growing older in America costs a 
lot of money. Before I was elected to Congress, I was the co-
director of the Oregon Gray Panthers, an organization for the 
elderly. I spent a lot of time visiting the seniors in their 
homes. And the majority of them were folks who had to stretch 
every last penny to get by.
    So this is an issue I take very personally. And even when 
our people do everything right, when they scrimp and they save 
over decades, when they give up vacations--they did not buy a 
boat, they lived modestly, they do everything they can to 
prepare for retirement--people run out of money when they get 
older. All it takes is one surprise illness or injury for the 
bills to start stacking up, or a family emergency, or damage to 
a home. Your savings dry up. That is the way real life is.
    And that is on top of those who do not have savings, the 
millions who could not save just because they had to walk an 
economic tightrope. And half of our people struggle to come up 
with $400 if they have an emergency. That does not mean that 
they have no right to see a doctor or get long-term care.
    Protecting those people is what Medicaid and the nursing 
home guarantee--and that is what it is; it is a guarantee--that 
is what Medicaid is all about. Without it, where do seniors 
turn when their savings dry up? How are nursing homes supposed 
to stay open without cutting the services down to frightingly 
poor levels? How are low-income seniors who want to stay in 
their homes going to afford their health care?
    So when you hear all this talk, colleagues, about 
flexibility, innovative solutions, holding the States 
accountable, in my view it is code for big Medicaid cuts. The 
consequences are dangerous, and they are personal.
    A couple of other points. The Trump administration has gone 
to court to have the entire Affordable Care Act thrown out. 
Protections for pre-existing conditions--gone. Tax credits for 
health care--gone. Rules banning the worst insurance company 
abuses--gone. Millions of people kicked off their health care.
    And it would just be devastating for young people like 
Jasper, pictured on this card in front of me. He is a little 
guy, but he's got a really big heart. And he was born with 
serious medical issues. Jasper, one of my constituents, has 
cystic fibrosis, cardiac and pancreatic problems, and hearing 
loss. He gets a lot of costly treatment. And for them, he and 
his family, the Affordable Care Act is a lifeline to the peace 
of mind they absolutely consider vital.
    Donald Trump has no backup plan for Jasper and his family 
if he successfully repeals the Affordable Care Act. That did 
not stop the President from saying during his State of the 
Union address that he had made an ironclad pledge to always 
protect seniors with pre-existing conditions.
    Donald Trump protects pre-existing conditions like sea 
lions protect salmon on our mighty Columbia River. It is the 
kind of protection that comes with an uptick in the mortality 
rate.
    So I am going to close with some comments about 
prescription drug prices. The President has had a lot of 
curtain-raising events on this. He was going to force big 
pharma to list drug prices on TV. That policy was blocked. He 
has talked about requiring rebates to go directly to patients. 
No follow-through. He was going to tie drug prices in the U.S. 
to drug prices abroad. Nothing there. He had a policy to speed 
approval of generics. No apparent effect. The reality is, 
patients are still getting mugged at the pharmacy counter. Drug 
prices are up again in 2020.
    Now, the Senate Finance Committee has worked long and hard 
on the prescription drug issue, as has the House of 
Representatives. And as I have said on a number of occasions, 
Chairman Grassley has been a good partner on this, and I hope 
that we can find a way to move all this good work forward.
    The bottom line is, the President has been making promises 
about bringing down drug prices for 3 years, and it has not 
gotten done.
    Again, Mr. Secretary, we appreciate your being here, 
particularly coming so quickly. There is a lot for us to talk 
about, so I look forward to hearing from the members.
    [The prepared statement of Senator Wyden appears in the 
appendix.]
    The Chairman. Before I call on the Secretary, to repeat for 
some people who have just come in, we are going to keep things 
going while we have votes. So come back if you want to ask 
questions, because the Secretary has to leave at 12:30.
    Mr. Azar is Secretary of the Department, as I have said. 
Prior to his current position, he served as general counsel at 
HHS for 4 years, 2001 to 2005, and Deputy Secretary from 2005 
to 2007. Secretary Azar earned his bachelor's degree from 
Dartmouth College, and has a law degree from Yale University.
    Proceed, sir. Welcome.

  STATEMENT OF HON. ALEX M. AZAR II, SECRETARY, DEPARTMENT OF 
           HEALTH AND HUMAN SERVICES, WASHINGTON, DC

    Secretary Azar. Chairman Grassley and Ranking Member Wyden, 
thank you for inviting me to discuss the President's budget for 
fiscal year 2021. I am honored to appear before this committee 
for budget testimony as HHS Secretary for now the third time, 
especially after the remarkable year of results that the men 
and women at HHS have produced.
    With support from this committee in many respects, this 
past year we have seen the number of drug overdose deaths begin 
to decline for the first time in 2 decades, another record year 
of generic drug approvals from FDA, and historic drops in 
Medicare Advantage, Medicare Part D, and insurance exchange 
premiums.
    The President's budget aims to continue delivering these 
kinds of results and move toward a future where HHS's programs 
work better for the people we serve, where our human services 
programs put people at the center, and where America's health-
care system is affordable, personalized, puts patients in 
control, and treats you like a human being and not like a 
number.
    That is the vision behind this budget. I want to note that 
HHS has the largest discretionary budget of any non-defense 
department, which means that there are, again this year, 
difficult decisions made in order to put discretionary spending 
on a sustainable path. The President's budget proposes to 
protect what works in our health-care system and make it 
better. And I will mention two ways we do that: first, by 
facilitating patient-centered markets and health care, and 
second, by tackling key intractable health challenges.
    The health-care reforms in the President's budget aim to 
put the patient at the center. It would, for instance, 
eliminate cost sharing for colonoscopies after discovery of a 
polyp, a life-saving preventive service. We would reduce 
patient co-insurance and promote competition by paying the same 
for certain services in hospitals and out-patient settings.
    The budget endorses bipartisan, bicameral drug pricing 
legislation, like the plans formulated by Chairman Grassley and 
Ranking Member Wyden and supported by many members of this 
committee, as well as price transparency efforts that many of 
you have championed.
    These reforms will improve Medicare and extend the life of 
the Hospital Insurance Trust Fund for at least 25 years. We 
propose investing $116 million in HHS's initiative to reduce 
maternal mortality and morbidity, and we propose reforms to 
tackle the rural health crisis in America, including expansions 
of telehealth and new flexibility for rural hospitals.
    The budget increases investments to combat the opioid 
epidemic, including the State Opioid Response Program, which we 
have focused on providing medication-assisted treatment while 
working with Congress to give States flexibility to address 
stimulants like methamphetamines.
    We request $716 million to expand implementation of the 
President's initiative to end the HIV epidemic in America by 
using the effective evidence-based tools we have at our 
disposal, as we have already begun doing, with Congress's help, 
in four jurisdictions.
    Finally, the budget reflects how seriously we take the 
threat of other infectious diseases such as the China 
coronavirus, which has been a top priority for me as I have led 
the Federal Government's coordinated response as chairman of 
the President's Coronavirus Task Force.
    The budget prioritizes funding for CDC's infectious disease 
programs and maintains effective investments in hospital 
preparedness. Last night we announced the 14th confirmed case 
of the China coronavirus in the U.S., and this morning CDC will 
be announcing the 15th, both of whom came from Wuhan and are in 
quarantine.
    As of today, I can announce that the CDC has begun working 
with health departments in five cities to use its flu 
surveillance network to begin testing individuals with flu-like 
symptoms for the China coronavirus. Many questions about the 
virus remain, and this effort will help see whether there is 
broader spread than we have been able to detect so far.
    On the human services side, the goals of the budget are 
similar. We cut back on programs that lack proven results while 
reforming programs like TANF to drive State investments in 
supporting work and all the benefits it brings for well-being.
    This year's budget aims to protect and enhance Americans' 
well-being and deliver Americans a more affordable, 
personalized health-care system that works better rather than 
just spends more. I look forward to working with this 
committee, as always, to make that common-sense goal a reality.
    Thank you, Mr. Chairman.
    [The prepared statement of Secretary Azar appears in the 
appendix.]
    The Chairman. We will have 5-minute rounds of questioning. 
I am going to start out with what you probably would expect me 
to start out with. I referred to it in my opening statement. In 
that statement I commended you for your leadership in the 
effort to lower prescription drug prices, and particularly 
helping us with our legislation.
    Can you speak to the proposal in the budget to reduce 
prescription drug costs and its notation of $135 billion in 
reduced spending? Also, include in your answer your general 
thoughts on how this could be helpful to me and Senator Wyden 
and all the people on this committee who support our bill.
    Secretary Azar. Well, thank you, Mr. Chairman. And I have 
been delighted to work with you and Ranking Member Wyden on 
this legislation. This package is a reasonable package. It is 
bipartisan, and it can really help in terms of helping to 
control list price increases, to decrease out-of-pocket 
spending by patients--especially by our seniors--and to fix the 
incentives in the Part D program to really give the plans the 
incentive to really negotiate hard against big pharma.
    I do not understand why big pharma is not supporting it. 
These are important reforms. Packages like this and other 
bipartisan efforts are important at saving seniors money, 
stopping list price increases, and getting better negotiations. 
And I think these are some of the best reforms that we can work 
on together.
    The Chairman. Thank you.
    I am interested in rural health care. This committee has 
been in the middle of that for at least 3 decades. It is 
difficult to keep high-quality medical care in those 
environments.
    Over the past decades, I championed landmark rural health-
care legislation. We have had some successes, but things change 
rapidly--well, maybe not ``rapidly,'' but they slowly change in 
rural America. So we have problems still developing.
    I am very pleased to see in the President's budget that it 
contains a renewed focus on rural health care. While the HHS 
budget material provides a broad outline of past 
accomplishments and future goals, it does not contain specific 
details about the policy.
    That is why today I wanted to give you, Secretary Azar, an 
opportunity to explain in some detail how the administration 
plans to build rural delivery models, leverage technology, and 
create appropriate rural provider payments.
    Secretary Azar. Thank you, Mr. Chairman. And thank you for 
your decades-long advocacy supporting rural health care. It has 
been a passion of mine also. I am the product of rural health 
care in America. And rural health care is suffering, and we 
have developed a comprehensive agenda. And I am delighted to 
see how prominent it is in this year's budget, and you will be 
seeing a lot of activity this year.
    Some of the changes that we do propose in our budget--one 
of them is to help stop rural hospital closures. So what we 
would do is ask Congress to allow critical access hospitals in 
rural areas to voluntarily convert to emergency hospitals so 
that they do not have to comply with the regulatory 
requirements of also offering in-
patient beds. They would get the same Medicare payment rates as 
other emergency departments paid under the out-patient, 
prospective payment system, plus an additional payment.
    We also are working to advance telehealth and telemedicine 
in our proposal, expanding regulatory flexibility for providers 
who participate in Medicare Advanced Payment Models by lifting 
telehealth restrictions. And we also want to modernize payments 
for rural health clinics.
    These FQHCs in rural America deserve more money. We want to 
increase flexibility for critical access hospitals to convert 
to these out-patient-only facilities and continue serving their 
communities.
    The Chairman. Ranking Member Wyden, Senators Young, Cardin, 
and I sent a letter to the United Network on Organ Sharing 
questioning the adequacy of their oversight. And I know you 
appreciate this as a problem. There are more than 600 people in 
Iowa waiting for organ transplants, and 113,000 nationwide. 
About 20 die a day without getting the help.
    What is HHS doing to take a more active role in providing 
oversight over this system, to hold this government contractor 
and procurement organizations accountable? Because we think, 
except in a few cases, there is not really a very good effort 
made to harvest organs.
    Secretary Azar. So, Mr. Chairman, in regard to the 
particular issue of liver allocation policy, I just want you to 
know, as I have said before, that I share your concerns and 
other members' concerns and frustrations with UNOS and the 
decision-making process there.
    I have been rebuffed also in my efforts. The oversight 
there that we have, as HHS, is limited by statute to protect 
the independence of the organ allocation policies. But we are 
happy to work with Congress, if it ever saw fit to address that 
question. More broadly, though, around the supervision of the 
organ procurement organizations, we have proposed a 
comprehensive rule bringing first-time-ever real accountability 
and metrics to these OPOs to get more organs procured, and more 
of them successfully transplanted.
    So that is a major focus of our efforts there through the 
OPO accountability regulation that we have now proposed.
    The Chairman. Senator Wyden?
    Senator Wyden. Thank you, Mr. Chairman.
    Mr. Secretary, I am going to walk through a few facts that 
I think are on the record, and then I have a particular 
question for you.
    The President talks about health care in terms of his 
vision. And yet, when I look at the specifics, it really looks 
like a nightmare to me. First, I touched on the Graham-Cassidy 
bill, in addition to the punitive approach to Medicaid. It 
would have gutted pre-
existing condition protections. We have witnesses who actually 
said that at the witness table. The waivers, the 1332 waivers, 
basically are green-lighting junk insurance. Burdensome 
paperwork requirements led to thousands losing coverage in one 
State alone. And what do we have to show for it?
    The uninsured rate has gone up each year since 2017, and 
the rate of uninsured kids is up for the first time in a 
decade. So to me, this ``vision'' looks more like a nightmare. 
And that is because we are going to have worse health care and 
for fewer people.
    Now I want to ask a specific question with my time about 
women's health under TrumpCare. Since day one, the 
administration has taken aim at women's health by making it 
harder and harder for women to access the health care they 
need.
    Last month the administration approved Federal Medicaid 
funding for a Texas program that excludes qualified family 
planning providers like Planned Parenthood. So the 
administration has a clear agenda, making it harder for 
patients to see the providers they trust, and the 
administration is now proposing a budget that would gut even 
more women's health protections.
    Medicaid is a lifeline for so many women. It is the 
Nation's primary payer of essential family planning services, 
and it would be slashed to the bone, putting coverage for 
millions of women and girls in jeopardy.
    President Trump's ACA repeal lawsuit would end the ironclad 
protections for pre-existing conditions--again, vital for 
women--taking America back to the day when a woman could be 
charged more for health care just for being a woman.
    So my question, Secretary Azar, is why should the 
Department of Health and Human Services be in the business of 
telling women which doctors they can go and see?
    Secretary Azar. So, Senator Wyden, of course we do not have 
any role in telling women or men where they should go in terms 
of which doctors they would see. In our programs we grant 
flexibilities to States in running the Medicaid program. And we 
have made major investments, and we continue to make major 
investments, in direct health care service delivery for women's 
health. It is a major priority of ours to ensure access to 
health care for women and girls across their entire lifespan, 
including community health centers, where 58 percent of our 
clients in community health centers are female, and 62 percent 
are racial and ethnic minorities. We are going to spend in this 
budget approximately $137.5 billion on women's health, and I 
look forward to working with you on ways we can keep advancing 
women's health care.
    Senator Wyden. What I will say, Mr. Secretary, because I 
think I have outlined that the Medicaid cuts--I just would 
respectfully disagree with you on that particular point. You 
all are telling the States that they can tell women which 
doctors they are going to see, and that is what I think is 
particularly unfortunate.
    It seems to me that women in this country, particularly 
women of modest means, should not in effect be excluded from 
the kind of health-care choices that millions of other 
Americans have. And you are basically green-lighting that kind 
of opportunity for the States.
    And one last question, talking about how Medicaid and 
health care is, in my view, paying for tax cuts. Now confirm 
some of the numbers in the President's budget for me. Let us 
just stick to the numbers.
    Is it right that the President's budget reduces Medicaid 
spending by $920 billion?
    Secretary Azar. So the President's budget has changes to 
Medicaid that would actually result, every single year, in an 
increase in Medicaid. Right now, Medicaid increases 5.4 percent 
per year, which is twice what the average worker makes in a pay 
increase per year. We would change that to a 3.1-percent 
increase every year, putting it in line----
    Senator Wyden. Secretary Azar, doesn't the budget say that 
it would be $920 billion less than it would be without the 
budget? Yes or no?
    Secretary Azar. That is less in the rate of growth. But it 
again grows every single year----
    Senator Wyden. That is a ``yes.''
    Is it also correct that the President's budget reduces the 
net Medicare spending by $450 billion?
    Secretary Azar. Again, Medicare spending is growing at 
7.8--I believe it is 7.3 percent per year. We would reduce the 
rate of growth to 6.3 percent by making some common-sense 
changes that MedPAC and others have recommended, like moving 
graduate medical education and uncompensated care to general 
tax revenues, site-neutral payments, finally bringing some 
control to post-acute payments--nothing that impacts 
beneficiaries.
    Senator Wyden. My time is up, because I have two or three 
other kinds of examples. What I am concerned about is paying 
for unpaid breaks to professionals and big pharma on the backs 
of low-income Americans, and I think that is what this budget 
adds up to.
    Thank you, Mr. Chairman.
    The Chairman. Senator Portman, and then Senator Stabenow.
    Senator Portman. Thank you, Mr. Chairman,
    First of all, Mr. Secretary, I appreciate the job you are 
doing. And I wanted to comment on a few things in the budget. 
There is a lot in there. I wish I had more time. But first on 
prescription drugs, let me just make this comment.
    We voted, as you know, on a bipartisan package, I think 19 
of us voted for it. I was one of them. And you put a 
placeholder in the budget, I noticed, that is roughly 
equivalent to the amount of savings that we would have through 
the prescription drug cost reductions that we passed in this 
committee. I thank you for that, and I urge you to continue 
working with us on a bipartisan basis to find a solution. It is 
really important to the constituents all of us have back home. 
And prescription drug prices is an area where I think we have 
the potential to find some common ground.
    I also noticed that in the opioid area you have increased 
funding for the State opioid grant program, and also for the 
Comprehensive Addiction Recovery Act, which I appreciate. We 
need it badly. I would love to say that we have been victorious 
in this battle and that we are turning the tide.
    We do have fewer overdose deaths, but the reality is that 
crystal meth and cocaine, which are psycho-stimulants, have 
come back with a vengeance. And so I really appreciate the 
flexibility you are providing in the State Opioid Response 
Grants, because that is what we are hearing back home in Ohio.
    I just finished another round of visits in Ohio talking to 
folks about this, and unfortunately we had a spate of overdose 
deaths just in the last couple of weeks with this mixture of 
fentanyl, cocaine, and crystal meth. So, thank you for that 
flexibility.
    I have a question for you on Money Follows the Person. This 
is a great program. Ohio is one of the leaders in it, as you 
may know. It is a demonstration program right now. We want to 
make it permanent. We keep trying to do that, unsuccessfully. 
You have put in the budget that it should be permanent. And it 
is a great program, because it is a win/win. It actually 
provides better care to get people out of institutional care 
into home care, but it also saves the government money. You 
know, what's wrong with that?
    And so I would hope that, for our seniors in Ohio and 
people with disabilities in Ohio, your budget actually is 
successful in making it permanent. It has already transitioned 
90,000 Americans from institutional care to home and community 
care.
    You have a report from HHS saying this lowers hospital 
readmission rates among those who are coming out of nursing 
care, which is one of our great objectives. Additionally, it 
says that the average per-person monthly cost decreases from 
$13,500 per month to $9,500 per month. So it is providing 
better care, and it is also less expensive.
    One of our challenges, frankly, has been that CBO is 
skeptical of the cost savings. Can you talk about that for a 
second and also commit to working with CBO to try to come up 
with more realistic costs based on the data you have given us?
    Secretary Azar. Yes, we certainly will work with them. I 
struggle with actuaries and how they do their calculations in 
terms of savings, because we have seen the MFP program. It is 
popular. The results of this demonstration have been positive, 
just as you said. And thank you for your leadership on that.
    It is time for us to convert this from being a grant 
program, with the lack of predictability that comes with a 
grant program, to a State option where they can build that into 
the intrinsic fabric of their program. So we are happy to keep 
working with you on that.
    Senator Portman. Great. Thank you.
    On hospice, I am a big supporter. Ohio is at the cutting 
edge of hospice. We were one of the States that pushed hard for 
Medicare coverage for hospice back in the day.
    I am told that, based on a MedPAC study, that 2017 marked 
the first time ever that a majority of Medicare beneficiaries 
selected hospice services for their end-of-life care. And I 
think that is a good thing. In my own family, we have used 
hospice, to be sure. With end-of-life challenges, people are 
able to have the dignity that they deserve.
    And yet, there are some hospice organizations that are not 
meeting the quality standards that we all want. Senator Cardin 
and I have been working on this issue. We have legislation we 
have introduced. Again, it is something I see in your budget, 
because you have said that you would like to see some similar 
penalties to the ones we have for bad actors in this space.
    And so, what my request today would be is, would you be 
willing to work with us to provide more input into our 
legislation, specifically some technical assistance that 
apparently we have had a tough time getting? I know HHS is 
busy, but we really want to move this forward. We think it 
would be a good bipartisan accomplishment of this committee 
and, most importantly, can help so many constituents back home 
who are looking for that dignity at the end of life, but also 
high-quality care.
    Secretary Azar. Absolutely; we would be happy to help you 
on that. We, in our budget, proposed that we have greater 
ability to make transparent the accreditation surveys for 
accredited facilities so that people can really make informed 
choices.
    We also make a major investment, with $442 million, in the 
survey and certification work to ensure that we are doing our 
job with the expanding number of providers.
    And then finally, with regard to hospice in particular, we 
are proposing one of the OIG's recommendations there of how we 
can bring modified payments to hospice providers so that they 
reduce the incentives for hospice to actually seek out 
beneficiaries in nursing facilities.
    Senator Portman. We look forward to working with you on 
that, and again, to hopefully passing some legislation that 
will give you some statutory authority to do that.
    Thank you. Thanks, Mr. Chairman.
    The Chairman. Senator Stabenow?
    Senator Stabenow. Thank you, Mr. Chairman and Ranking 
Member. Welcome, Secretary Azar.
    I want to first start expressing concerns about the 
Medicare, Medicaid cuts, and other cuts. But then I want to 
transition to something that you and I have talked about a 
number of times where we can work together and actually improve 
people's quality of life and access to care. And we have an 
opportunity to do that this year.
    But first I just want you to see Henry. This is Henry. He 
is 9 years old. He lives in Grosse Pointe, MI. He loves people. 
He greets everybody with a big hug. He loves performing. He is 
in dance class and sings karaoke at home. The challenge is, he 
is also living with a number of pre-existing conditions, 
including Down syndrome, autism, and severe reflux.
    As you can imagine, he has been in and out of the 
hospital--a lot of challenges. And his mom Kera said, ``If we 
did not have access to affordable health coverage, we would 
have been bankrupt before Henry was 1 year old.''
    And so first let me say, in addition to all of the cuts on 
Medicare and Medicaid, as well as health research--which I am 
very concerned about--that are in the budget, there is nothing 
that stops the lawsuit on the ACA going through the courts that 
would take away coverage on pre-existing conditions and 
everything else under the ACA.
    And I am very concerned that when the court initially 
agreed with the fact that the ACA should be repealed, including 
pre-
existing conditions, the President tweeted, ``Great news for 
America.'' Not great news for Henry. And so I am very, very 
concerned about that.
    The area where we have the opportunity to work together and 
to really make a difference is in the area of community mental 
health and addiction services. And when you said grants are not 
enough, boy, are you right. We have champions in this committee 
for efforts around addiction and opioid treatment and so on. It 
is always a grant, and when the grant runs out, so sorry.
    So the only folks who are asked to do that in health care 
are the mentally ill and people with addiction. And so as you 
know, Senator Blunt and I--and now we have 12 members--10 
Democrats, 10 Republicans. We are adding people in pairs, and 
we expect to add more people. We have a House bipartisan effort 
to expand an eight-State demonstration project that was set up 
that literally shows that we save money. People are not in 
jails. They are not in emergency rooms. But when you do quality 
community mental health out-patient care and addiction 
services, you not only save lives, you save money.
    And so we want to expand that. The chairman is very 
supportive, the ranking member, many people. There are 19 
States that actually meet the quality standards now and are 
ready to take that next step. And we are also doing grants to 
help every State be able to get ready.
    But I wonder--there has been a study that has shown, in the 
last 2 years, some of the results, the positive impacts that 
have happened as a result of what has been done in the 
Excellence in Mental Health and Addiction Treatment Act. And I 
wonder if you might share some of those, if you are aware of 
the results that we have seen in just 2 years?
    Secretary Azar. Absolutely, Senator. And thank you for your 
leadership on the CCBHC issues. This program, the Certified 
Community Behavioral Health Clinics program, has already served 
over 24,000 individuals as of August of 2019.
    These are clinics, as you said, that provide a 
comprehensive, coordinated range of evidence-based treatment 
and behavioral health services to individuals. And the results 
show that we see that they are making services more convenient. 
They are introducing more frequent appointments, tailoring 
services offered to diverse populations, such as school-aged 
youth and veterans. And they are expanding access to care in 
our communities.
    So in our budget, we proposed to extend this program 
through fiscal year 2021 for the eight current participating 
hospitals, because we are believers in this program, and 
obviously we are happy to continue working with you as we think 
about expansion to other States.
    Senator Stabenow. Well, thank you, Mr. Secretary. And I 
want to thank Chairman Grassley and Ranking Member Wyden for 
putting the full extension across the country to the States 
that have met the quality standards into your health-care bill 
that has come forward on health-care extenders.
    We have a chance in May to do this right. I will also say 
that, if you want to talk to folks who are excited about this, 
talk to a sheriff in one of the communities where folks are no 
longer going to the jail. They are now getting community out-
patient treatment. Talk to the hospital folks who are running 
emergency rooms who no longer have folks sitting in their 
emergency room, but they are getting care through the 24-hour 
psychiatric emergency centers that have been set up.
    And the final thing I would say, Mr. Chairman, is that this 
is actually a good news story in that CBO, which we all 
struggle with around health-care savings, has actually dropped 
more than in half their original estimate on what it would take 
for us to pass the Excellence Act this year.
    And so I hope you will lean in heavily with us, because it 
is my intent to make sure the mentally ill and people with 
addiction are not left behind this year. Thank you.
    The Chairman. I will pass over Senator Menendez and go to 
Senator Carper.
    Senator Carper. Mr. Secretary, welcome. Thank you for 
taking on a tough job. And we appreciate that and the work that 
you are doing. We do not always agree, but we appreciate it 
nonetheless.
    I think Senator Grassley has already raised the issue of 
bipartisan legislation that he and Senator Wyden and others on 
this committee crafted in order to try to reduce prescription 
drug prices for Medicare beneficiaries.
    It is not every day that we have the kind of consensus that 
we had in this committee on this issue, but we are encouraged 
by that. As you know, the legislation would lower drug prices 
for seniors, and it would lower drug prices for Medicare and 
Medicaid and require drug companies to publicly justify the 
prices for their products, in a day and age when we are trying 
to find ways to save money with respect to pharmaceutical costs 
and other health-care costs in ways that are humane to the 
people.
    I think this is a very good effort, and we are proud of it. 
Let me just ask, do you and the President support the Finance 
Committee's bipartisan bill to reduce drug prices?
    Secretary Azar. So, we have been very active in working 
with the bipartisan leadership of this committee to try to 
advance this legislation. If we want to get this or some other 
comparable bipartisan package through, we need to do this. This 
is certainly one that fits the bill.
    If there are other approaches that we need to take to try 
to get this to the floor and get it passed, we are open to 
that. But we have been very deeply engaged with the Democrats 
and Republicans on this committee to advance the Grassley-Wyden 
legislation.
    Senator Carper. Thank you. Some of our Republican 
colleagues believe that the Finance bill would amount to price 
controls in the pharmaceutical industry and jeopardize 
innovation for new therapies. And as a former CEO, a native I 
think of Salisbury, MD, who was a former CEO of a major drug 
company, do you agree with these concerns?
    And the second half of that question would be, do you think 
drug companies can continue to innovate under the Finance 
Committee's bill?
    Secretary Azar. With all respect, I fundamentally disagree 
with the notion that the inflation penalty provisions that are 
in the Grassley-Wyden bill constitute price caps or price 
controls.
    These are reasonable restrictions on price increases that 
create, basically, a financial disincentive to the year-after-
year price increases that we see. And as long as those 
incentives are in the system, we will continue to see year-
after-year price increases, and the Grassley-Wyden package 
would contain that.
    It is important to remember, these drug companies already 
sign contracts with the middlemen with long-term price 
predictability guarantees. So this is not an alien concept to 
the drug companies. It exists as a commercial practice already. 
We would just get the benefit for our seniors and our taxpayers 
through this program.
    And I am sorry, Senator, was there a second part to your 
question? I want to make sure I get that.
    The Chairman. Senator Carper, before you repeat that second 
question--without taking time away from you--would not another 
way of saying it be, since we pay $138 billion of taxpayers' 
money for Medicare drugs, that we would be just capping the 
subsidy that we give to pharmaceutical companies?
    Secretary Azar. Well, it does. And that is one of the 
really important innovations of the Grassley-Wyden package: it 
actually changes the dynamic. Right now, interestingly, the 
middlemen who run these drug plants have every incentive 
actually for the drug companies to jack up their list price 
because it raises the senior to what is called ``the 
catastrophic phase'' where the government pays most of the cost 
of that insurance through the reinsurance.
    This would be fixed by Grassley-Wyden.
    The Chairman. Senator Carper?
    Senator Carper. Thank you, Mr. Chairman. The second half of 
my question I do not think you got to was, do you think drug 
companies can continue to innovate under the Finance 
Committee's bill?
    Secretary Azar. Oh, absolutely. The changes here still 
leave plenty of room for profit margin, innovation, and 
investment. There would be no material impact in any way to the 
R&D enterprise in the United States, which we are all committed 
to.
    Senator Carper. All right. My colleagues hear me quote from 
time to time Matthew 25, which goes something like this: ``When 
I was hungry, did you feed me? When I was naked, did you clothe 
me? When I was thirsty, did you give me to drink?''
    It does not say anything about, when I desperately needed 
pharmaceuticals, it saved my life. It does not say anything 
about, did you provide that? But I think the intent is clear.
    And sadly, with respect to the President's budget, the 
answer to these questions is, ``not entirely,'' but too often, 
``no.'' A hundred million Americans have, as you have heard, as 
you know, 100 million of our fellow Americans have pre-existing 
conditions. These folks depend on you for protections and 
delivery of health care and the promise of affordable health 
insurance regardless of their health conditions.
    The President has doubled down, though, on the Texas 
lawsuit against the ACA, and this budget contains no plans, as 
far as I can tell, to replace the ACA if the court strikes down 
the law, which will leave millions of additional Americans 
stranded without health insurance, Medicaid, and high 
prescription drug costs, all while cutting taxes for the 
wealthiest among us.
    My question, Mr. Secretary: how will the President protect 
Americans with pre-existing conditions if the ACA is struck 
down in the courts?
    Secretary Azar. So the President has been very clear that 
he will never sign legislation that does not--that would 
replace the Affordable Care Act if it does not have adequate 
protections for those with pre-existing conditions.
    It is important to remember, though, that even under the 
ACA there is a statement of protecting against pre-existing 
conditions, but let us say you are a two-person family making 
$70,000 a year in Missouri. You are going to pay over $30,000 a 
year for premiums, and you are going to have over $10,000 out-
of-pocket.
    So I do think we have to not over-glamorize the current 
situation in terms of the protection of those with pre-existing 
conditions, because for those people, that insurance card is in 
some respects a meaningless protection for pre-existing 
conditions. And we want to work with Congress, if there is the 
opportunity to replace it with something that really would work 
for people.
    Senator Carper. My time has expired. Let me just conclude 
with this quick comment, if I could. My understanding is, if 
the ACA is struck down in the courts, the President will not 
have to sign anything. That will be it. And I want us to keep 
our minds and our eyes on that. Thank you.
    The Chairman. Senator Menendez?
    Senator Menendez. Thank you, Mr. Chairman.
    Mr. Secretary, you are a named defendant in Texas vs. U.S., 
correct?
    Secretary Azar. Yes; I am one of them, yes.
    Senator Menendez. Is it true that this administration has 
taken the position that it will not defend the Affordable Care 
Act in court and supports striking down the entire law?
    Secretary Azar. The position of the Justice Department is 
that the individual mandate is unconstitutional, and that as a 
result the other provisions in it are not severable from that 
individual----
    Senator Menendez. So in essence, it would strike down the 
entire law, and the Justice Department is part of this 
administration, is it not?
    Secretary Azar. Yes. They represent the administration in 
the Federal courts, yes.
    Senator Menendez. So therefore it is the administration's 
view that the entire law of the Affordable Care Act should be 
struck down.
    So if it is struck down, what is your immediate plan to 
replace it? If tomorrow the court decides that in fact the 
entire law is struck down--millions have health insurance who 
did not have it before. Many under Medicaid expansion have 
health insurance who did not have it before. Millions have 
protections against pre-
existing conditions who did not have those protections before. 
Millions have no more lifetime cap or ceiling on the 
expenditures that they have, especially if they have a serious 
illness.
    So what is the administration's plan? I have not seen it 
yet, and I think this committee has jurisdiction.
    Secretary Azar. So the litigation still has a very long way 
to proceed. The Fifth Circuit, as you know, has remanded the 
case to the District Court for a very searching, detailed 
analysis of every provision----
    Senator Menendez. Why are we going to wait? Why would you 
wait, with the health care of millions of Americans and their 
fate, to see what the court decides? It seems to me we have 
been hearing about killing Obamacare since it was created. 
There have been years to have your own version of what it is.
    Why would you wait till there is a disaster to then deal 
with the millions of Americans who have health-care insurance? 
Do you see this young man? He is alive today because of the 
Affordable Care Act. And like him, millions in my State and 
across this country are alive because of it.
    I do not know what you are waiting for. If you have a 
better idea, show us. But I have yet to see one plan that the 
administration has put forward for the health care of millions 
of Americans. What are you waiting for?
    Secretary Azar. We would wait until there is a final 
judgment by the final court of authority. In this case, it 
would obviously be the Supreme Court.
    There is a very long process to go through to even see 
whether the statute is struck down, or even in part is struck 
down by the Supreme Court. These are hypotheticals at this 
point. We are faithfully administering the ACA now----
    Senator Menendez. Well, let me say, Mr. Secretary, these 
are hypotheticals that we do not play with. This is not some 
abstract consequence, if it happens--not an abstract 
consequence, if it happens.
    Let me ask you this. The President's 2021 budget calls for 
zeroing out CDC funding for gun violence research. Did the NRA 
tell the administration to do this? Did you have influence from 
the NRA to zero out funding for gun violence research?
    Secretary Azar. I have no idea about any interactions 
there. I can tell you why we did not put that in the budget is, 
we have a tight budget. We have a 9-percent cut at HHS, because 
the caps, the discretionary caps for this year go from, I 
think, 7.5 percent in 2020 to a +1.05-percent or a 1-percent 
increase. In 2021, we are one of the--we are the largest non-
Defense discretionary part. We absorb a disproportionate share 
of that.
    And so we had to prioritize. I prioritized towards 
infectious disease, global----
    Senator Menendez. Well, if we did not have $1.5 trillion in 
tax cuts unpaid for, driving huge debt, and we were not further 
plussing up the military beyond everything that has been done, 
you would have some money.
    It seems to me that understanding the consequences of gun 
violence, how we get around it, would save lives here in the 
United States. One of the priorities of a government is to save 
its people.
    Let me just ask you one final question in the less than a 
minute that I have. The Remain in Mexico policy misleadingly 
called ``The Migrant Protection Protocol'' has forced over 
60,000 asylum seekers to wait in dangerous conditions in Mexico 
for their U.S. immigration court hearing. Over 800 cases of 
murder, rape, torture, kidnaping, and other violent assaults 
against asylum seekers returned to Mexico have been reported.
    What mechanism or process is there in the Office of Refugee 
Resettlement used to identify and track children affected by 
the MPP? What does ORR systematically notify when an MPP-
affected child is identified?
    Secretary Azar. Well, as you know, HHS and ORR have no role 
in determining eligibility for the MPP, which aliens are 
enrolled in that, or whether an alien is allowed to enter into 
the United States.
    And if a child comes in unaccompanied, then it would follow 
the usual unaccompanied alien children program protocols. If a 
child returns with their family to Mexico as part of the MPP, 
that is not subject to the statute and ORR's jurisdiction.
    Senator Menendez. Yes, but to the part where the child is 
unaccompanied and ultimately is returned to family in Mexico, 
are you doing any tracking?
    Secretary Azar. If children are determined to be enrolled 
in the MPP and ORR and DHS determine the child's parents are in 
DHS custody, or if they return to Mexico and leave the child 
here, we collaborate to ensure that we can safely reunify the 
child.
    DHS determines whether there is a criminal history that 
would preclude reuniting. We coordinate to--DHS informs ORR's 
intake teams that the child's referral is with a family 
enrolled in the MPP so that we try to keep track of everybody. 
If a child comes to us at the family's request, that they 
decide to return to Mexico and leave the child here, we work 
with DHS to keep them in contact, as we do with any child in 
our care, to make sure they are in telephonic contact with the 
parents as regularly as possible.
    So we track that between them, whenever we receive a 
referral like that.
    The Chairman. Senator Cardin?
    Senator Cardin. Thank you, Mr. Chairman, and thank you, Mr. 
Secretary, for your service.
    I want to follow up on prescription drugs first, if I 
might. You talked about the middle-person, the pharmaceutical 
benefit manager, who is supposed to be there to protect the 
patients. In reality, they are not doing that.
    We have a chance of really passing a prescription drug bill 
in this Congress. So I hope we can follow the leadership of our 
chairman and ranking member and get a bill to the finish line.
    But I want to tell you one of my pet peeves. We are the 
wealthiest nation in the world. We spend by far the most on 
prescription drugs, and we have 200-plus common drugs that are 
in shortage in America. These are relatively inexpensive drugs, 
and they are critically important for care.
    We are talking about newborn babies, the drops that they 
need. We are talking about bladder cancer patients who need the 
therapy drug that is not available for treatment. That is 
outrageous! No one is speaking out in regards to these 
necessary drugs being available to consumers in this country.
    We need your help to make sure that we include this, so 
that we do look after the people in this country, and we 
recognize today that the pharmaceutical benefit managers are 
not protecting the patients of this country.
    Secretary Azar. Thank you, Senator. First, I am happy to 
talk about shortages. But I did want to give you a little bit 
of good news. You have been an advocate for many years of 
ensuring that CMS has a Chief Dental Officer. I am very pleased 
to announce that CMS is working through an interagency 
agreement with HRSA to bring onboard a Chief Dental Officer. 
So, thank you for your continued leadership there.
    Senator Cardin. Wonderful way to dodge my question, so----
[Laughter.]
    Secretary Azar. But thank you for your leadership. I 
completely share your passion around dental health and its 
central importance.
    In terms of drug shortages, there are several legislative 
proposals in our budget that would help us better prevent or 
mitigate medical product shortages. One of them would enhance 
FDA's ability to assess critical manufacturing infrastructure 
so we could collect better and more accurate information about 
supply chain management.
    We have--the FDA task force on drug shortages has three key 
recommendations, though. One of them is to create a shared 
understanding of the impact of the shortages and the 
contracting practices, particularly on generics, that may be 
contributing to them--sole-source procurements, low pricing, et 
cetera, that may be driving that.
    We also want to create a rating system around manufacturing 
quality, so that we could actually perhaps have a race to the 
top in generic quality on these drug shortages.
    And the third is to really promote sustainable private 
contracting practices. We have had a bit of a race to the 
bottom, I am afraid, in terms of generic procurements. And it 
has led to these types of sole-source generic providers.
    Senator Cardin. I think every one of those suggestions are 
what you need to do. But you can get congressional backup to 
what you are doing in legislation that is moving through here.
    Help us create the legislative mandates so we do not have 
drug shortages in America, of particularly essential drugs that 
are not being produced solely because they are not as 
profitable as other drugs. No one would argue that the 
pharmaceutical community is not making enough money. So why 
should we not have these drugs available?
    So let us look for a legislative backup. Your budget is 
really good on telehealth; I appreciate that very much. We have 
bipartisan support here to expand telehealth into Medicare. We 
need technical assistance from your agency so that we can give 
you, again, the legislative backup to expand telehealth 
services in this country. That is another area where I think we 
can work together and provide a permanent legislative basis to 
make sure we do not have drug shortages and expand telehealth. 
So I welcome your help.
    I want to cover one other issue. Yes, I have heard your 
explanation on the Medicaid cut that you call just a reduction 
in growth. I can tell you that, in Maryland and in every State 
in the Nation, in poorer neighborhoods it is difficult to get 
providers to provide the access of care that we need.
    And the block grant-type proposal you are making could very 
well lead to lower reimbursement rates for Medicaid patients, 
fewer services being provided, and less eligibility, which 
means there will be additional pressure for providers not 
locating in under-served communities.
    I just urge you, as you look at this, to develop the 
accountability system to make sure that we are providing top 
care to all communities in this country. Because today, we are 
not meeting that goal, and I am afraid that if you turn 
Medicaid into a block-grant program, you are going to find a 
much more difficult circumstance for under-served communities 
to have adequate health care.
    Secretary Azar. Yes.
    Senator Thune. Mr. Chairman, can you tell us what the plan 
is for the vote series, in terms of questions? Are we going to 
keep rolling?
    Senator Roberts [presiding]. We are going to keep rolling.
    Senator Thune. Okay; I would like to submit questions for 
the record.
    [The questions appear in the appendix.]
    Senator Roberts. Senator Hassan?
    Senator Hassan. Thank you, Senator Roberts. And I want to 
thank the chairman and Ranking Member Wyden for having this 
hearing. And thank you, Secretary Azar, for being here today.
    As others have noted, this committee has passed bipartisan 
legislation addressing the high cost of prescription drugs, and 
Senator Cassidy and I have been working with our colleagues on 
the HELP Committee to end the practice of surprise medical 
bills.
    The administration's focus should be on working with us to 
get those bills across the finish line to bring relief to 
patients and families, not on cutting Medicare and Medicaid.
    Secretary Azar, according to the Kaiser Family Foundation, 
nearly four in 10 adults with opioid use disorder receive their 
care through Medicaid. State Medicaid programs cover the cost 
of naloxone, medication-assisted treatment, residential 
rehabilitation, and out-patient therapy.
    Simply put, Medicaid saves lives. Moreover, according to 
your department, quote, ``The evidence is strong that treatment 
in managing substance use disorders provides substantial cost 
savings,'' close quote.
    Secretary Azar, this is a woman named Ashley Raymond who 
lives in Enfield, NH. This is a picture of her with her husband 
and her two children. She started using opioids at age 14 and 
was unable to access treatment until getting coverage through 
Medicaid.
    I met Ashley last year when I visited Dartmouth-Hitchcock 
Medical Center's Moms in Recovery program for pregnant or 
parenting moms grappling with substance use disorder, where 
Ashley is a client. Without Medicaid, she would be unable to 
afford her treatment or her prescription medication.
    Mr. Secretary, your own department recognizes the savings 
both in lives and in Federal spending achieved through a 
strong, sustained investment in Medicaid funding for treatment 
and recovery. How does that square with a budget that would cut 
almost $1 trillion from Medicaid?
    Secretary Azar. So, thank you. I hope that we will have 
your support for a new State option in the budget that would 
actually extend Medicaid coverage for pregnant women who are 
suffering from substance abuse disorder from 60 days to 1 year 
post-partum.
    Senator Hassan. But how does an almost $1-trillion cut 
square with our understanding that Medicaid saves dollars and 
saves lives? Because according to the CBO, your proposed cuts 
would cause States to start the process of ending their 
Medicaid expansion programs, which would put 17 million 
Americans at risk of losing coverage, including 57,000 people 
in New Hampshire.
    Your budget does not slow the Medicaid growth rate by 
addressing the rising cost of health care; it does so by 
cutting funding and eliminating access to coverage.
    Secretary Azar. So I may be incorrect, but I think the CBO 
analysis relates to previous budget proposals as opposed to 
this one, which is a broader allowance in the budget for us to 
work together with Congress to address how we can fix some of 
the perverse incentives in Medicaid that, for instance, have an 
incentive towards able-bodied adults in the system over 
pregnant women, aged, blind, disabled, and children of 
traditional Medicaid.
    Senator Hassan. Let me say this. I will follow up with you, 
but those proposals too essentially are cutting eligibility and 
keeping people away from health care, as opposed to looking at 
the rate of growth in health-care costs.
    So let us move on to a second question. As others have 
mentioned, your administration continues to support efforts to 
repeal the Affordable Care Act, including backing the lawsuit 
that would strike down the law in its entirety.
    The President claims that he wants to protect patients with 
pre-existing conditions. Yet, if the Affordable Care Act is 
repealed, health plans will once again be able to deny coverage 
to individuals struggling with substance use disorder.
    Now, in response to Senator Carper and Senator Menendez, 
you said that those protections were somehow meaningless. I 
will tell you, to the people in my State who have pre-existing 
conditions who can now get health care and do not face 
bankruptcy if they get sick, this is not ``meaningless,'' and 
this is not ``abstract.''
    Can you point to specific policies in your budget that 
would explicitly protect, not just patients struggling with 
substance use disorder, which would become a pre-existing 
condition, but also pregnant women or people with diabetes or 
heart disease, from receiving a coverage denial based on what 
their plan could once again deem a pre-existing condition?
    Are there specific elements in your budget that provide 
those protections?
    Secretary Azar. There would be no change to the Affordable 
Care Act that does not protect pre-existing conditions. So, 
even if at some remote date, in the remote possibility of the 
Supreme Court's final decision around the Affordable Care Act, 
the President--he will not allow there to be any statute come 
out that--he will veto it if it does not have adequate 
protections for pre-existing conditions. That is stated in our 
budget.
    Senator Hassan. And we would be a lot further along in the 
process of strengthening this bill, strengthening our health-
care system, if you all were not in court trying to tear it up. 
To echo what Senator Menendez said, you have had 3 years to 
come up with proposals.
    I am out of time. I will follow up with you and your office 
about some of the recent settlements that we have seen, and 
things we can do to prevent adverse incentives in terms of 
electronic health records and misuse of them. Thank you.
    Senator Roberts. Senator Cornyn?
    Senator Cornyn. Thank you, Mr. Chairman. Thank you, Mr. 
Secretary, for doing an outstanding job, and please convey our 
appreciation to the good folks at HHS who do the work day in 
and day out, which we very much appreciate.
    So I guess I am going to take the bait. Many of our 
colleagues have talked about the lawsuit involving the 
constitutionality of the individual mandate in the Affordable 
Care Act. And as you correctly point out, it could be years 
before that litigation is finally concluded by the Supreme 
Court.
    In the meantime, the leading candidate for the Democratic 
nomination for President of the United States is proposing to 
do away with all private health insurance, including the 
Affordable Care Act, and replace it with Medicare for All.
    So if you are a member of a labor union and you have 
negotiated a good health-care coverage, you would be prohibited 
from keeping that coverage and everybody would be forced into 
Medicare, without having even paid the premiums over your 
lifetime to be able to help contribute to the cost of it.
    What would be the consequence to our public health system 
in America if Medicare for All became the law of the land?
    Secretary Azar. Medicare for All would be devastating to 
America's seniors, and the American people. You know, right now 
America's seniors get a real benefit through Medicare, and that 
is what we call cross-subsidization. Basically Medicare 
underpays doctors and hospitals, and as a result, commercial 
insurance has to overpay providers just to keep them in 
business.
    If we move to Medicare for All, or even things like 
Medicare options that rely on Medicare rates, that gig will be 
up for America's seniors. That benefit will be gone. And what 
it will cause is, like we see in other socialist and European 
systems, a two-tier system of health care--the better 
hospitals, the better doctors will flee from that system and go 
off the books. And so it will reduce access for America's 
seniors.
    And as you said, it would take away what people like: 180 
million Americans have private insurance through their employer 
or through their labor union. That would be stolen away from 
them. People want improvement in health care, but they like 
their settled expectations there. That is why the President's 
philosophy is to protect what works and make it better. Do not 
take away what works for people.
    Senator Cornyn. Secretary Azar, talking about prescription 
drug reform and bringing down the cost to consumers and to the 
government, I supported the Finance Committee bill, the 
bipartisan Finance Committee bill, and look forward to 
continuing to work on that as well as other proposals. But we 
actually have a couple of bills that have made their way out of 
the Judiciary Committee with regard to patent gamesmanship, one 
that addresses the patent thicket problem where drug companies, 
for example, that make the drug Humira, have over 120 separate 
patents which block competitors and preclude lower prices for 
American consumers.
    Meanwhile, in Europe there are five different competitors 
available for consumers in Europe. We have this bill that I 
have introduced with Senator Blumenthal that was voted 
unanimously out of the Senate Judiciary Committee. We have 
tried to bring it up on the floor several times, but the 
Democratic leader has objected to it and blocked it on multiple 
occasions, even though he admits it is a good bill. He says it 
does not do as much as he wants to do, and I am willing to do 
more, but let us bank what we have in hand right now.
    If the Senate were to pass it and it were to come to the 
President's desk, would the President--would you recommend to 
the President that he sign that into law?
    Secretary Azar. So, I do not know if we have a formal 
statement of administration position on that piece of 
legislation. I will have to check on it, and I will get back to 
you on that. But your leadership on ending these patent 
thickets is vital. We need to address them.
    So the particulars on that statute, I want to get back to 
you on, but you are absolutely correct. Just one drug alone, 
the savings from biosimilar market entry would be billions of 
dollars of savings, but they layer patent upon patent upon 
patent, late-filed patents, manufacturing process patents, just 
added, added, added, extending beyond anything that one would 
have thought of as the original deal for intellectual property 
when the original products are approved. And it is what is 
stopping us from having a robust biosimilar market here in the 
United States.
    We are approving historic levels of biosimilars, but they 
have to get to market. They have to be reimbursed. There has to 
be a financial incentive to use them.
    Senator Cornyn. Mr. Secretary, the Medicaid Fiscal 
Accountability Regulation is a concern to my Governor, and to 
the State. We are worried--their stakeholders are worried that 
the rule, as proposed, could lead to hospital closures, 
problems of access to care, and threats to the safety net.
    I would just ask for your commitment here to continue to 
work with us and stakeholders in my State and around the 
country to make sure these concerns are addressed. Would you 
make that commitment?
    Secretary Azar. Absolutely. We, with the MFAR rule--we will 
work with States to help them recreate their practices in ways 
that are in conformity with the statute and try to be fair and 
equitable in all of our dealings with States.
    Senator Roberts. Senator Casey?
    Senator Casey. Thank you, Mr. Chairman.
    Mr. Secretary, it is good to be with you again. Thank you 
for being here. I am holding a picture, as a lot of our 
colleagues have, of folks whom we represent. These are the 
children of Erin Gabriel. She is from Beaver County. You were 
born in Cambria County, about five counties away to the west.
    The three children--and you may be able to see it from a 
distance, but I think you can see at least the outlines of the 
picture--the three children in here are Abby, who is in the 
wheelchair; Bridget; and Colin. Each one of these children--all 
three of them have autism. They all receive the benefit of 
Medicaid. Thank God for that.
    Erin's children depicted in the picture represent, I think, 
why we have a Medicaid program. Here is what Erin Gabriel said 
to me, quote, ``My children's health and lives are so much 
better because of the Medicaid services they receive, and they 
need to see their doctors and specialists much less because 
they receive these services early.''
    So their lives are much better. But because they got 
services early through Medicaid, they need to see their doctors 
and specialists much less.
    When we debate either the new regulation that Senator 
Cornyn just referred to, which is the subject of a lot of 
debate and real concern, or whether we debate the budget cuts 
to Medicaid, I, and I know so many colleagues on both sides of 
the aisle, will be thinking about families like Erin's.
    I am also thinking about a part of my State that you are 
familiar with, and I think a lot of people are. I represent a 
State that has 67 counties, but 48 of them are rural. I can 
show you a map of the State, but when you look at most of the 
State, it is a State of rural counties. We have I think, at 
last count, the largest rural population of any State in the 
Nation. We have about 3.5 million people who live in rural 
Pennsylvania. Some States have a huge rural population, they 
just do not have as many people.
    So when I think of rural Pennsylvania and rural America, we 
are of course thinking about rural hospitals. And you spoke to 
some of the concerns you have about rural communities.
    I think about the jobs at those hospitals. In my State, in 
25 to 30 counties, the first or second largest employer in the 
county is the hospital. And they are already operating under 
very tight margins.
    We know that rural children use Medicaid and CHIP at a 
higher rate than urban kids. It is actually a fact. Forty-five 
percent of rural and small-town kids get their health care 
through Medicaid and CHIP.
    Rural children were 29 percent more likely than urban kids 
to live in poverty. So if you are a child in a rural community, 
the Medicaid program takes on even greater significance than it 
does for other children. We know that in 2018, the uninsured 
rate for children actually went up for the first time, as 
Senator Wyden said, in a decade.
    So those are concerns that we have. And then we read the 
details of this year's budget, and the Medicaid cut is $920 
billion. And then you have the regulation that, not only 
Senator Cornyn's Governor, but a lot of other Governors in a 
bipartisan way, have real concerns with. In fact, the NGA 
letter dated January 29th says, quote, ``We're concerned that 
the proposed rule, as drafted, would significantly curtail the 
longstanding flexibility States have to fund and pay for 
services in their Medicaid programs.''
    So I ask you, on behalf of Erin Gabriel and lots of other 
families and the worries that they have that the Medicaid cuts 
will hurt their family, and the changes to Medicaid expansion, 
the 17 million who were covered by Medicaid expansion, many of 
them with an opioid or addiction problem, how do you--the 
number one question is--how do you justify those cuts? And 
number two, can you guarantee Erin Gabriel that her children 
will never lose their coverage under Medicaid as long as you 
are the Secretary of Health and Human Services?
    Secretary Azar. Well obviously, any changes to Medicaid are 
going to have to be done on a bipartisan basis, given the 
makeup of both houses of Congress. And so these are proposals 
that we think actually fix some of the poor incentives for 
children in our system.
    You know, the Medicaid expansion created a very perverse 
financial incentive for States to focus on able-bodied adults 
over the traditional children, aged, blind, disabled, and 
pregnant women in those programs. And so, part of our budget is 
a focus on actually, how do you restore the focus there and 
make sure Medicaid is there for them?
    Senator Casey. But just answer the question about the 
children. Will they lose coverage, those children with autism? 
Will they lose coverage?
    Secretary Azar. There is nothing in our budget that 
proposes to change the mandatory eligibility categories of 
traditional Medicaid.
    Senator Casey. I just hope you could at least guarantee the 
three kids with autism will never lose coverage as long as you 
have power.
    Thank you, Mr. Chairman.
    The Chairman. Senator Roberts?
    Senator Roberts. Thank you very much, Mr. Chairman. Thanks 
for coming back.
    Mr. Secretary, thanks for coming. I think you are doing a 
good job. It is an even-numbered year, so you get adjectives 
and adverbs that are a little tough from the other side of the 
aisle. Maybe here too. But I think you are doing a good job.
    I have 105 counties, by the way, and there are about 6 that 
are not rural. And we have 82 critical access hospitals in 
Kansas, and we are facing difficult situations way out there. 
And you are proposing a new model to allow these hospitals to 
convert to what we call ``an emergency facility'' that does not 
maintain in-patient beds. And we have seen this type of 
proposal recommended by MedPAC and other groups in the past, 
but it is new to the budget this year.
    And the budget proposes these newly converted hospitals be 
reimbursed at Medicare out-patient rates, plus an additional 
payment to assist with capital costs.
    Now last year, along with the rest of the Kansas 
delegation, we sent a letter to you--well, not to you, but to 
CMS--requesting that the agency work with Kansas hospitals in 
developing a pilot program for this type of model. They were 
just in to see me yesterday. And I told them I was going to see 
you.
    So I am going to ask you in their behalf and my behalf for 
an update on when we can expect to see a new model from the 
agency.
    Secretary Azar. So I--I am afraid I do not know the details 
on that Kansas model. I would be happy to ask the CMS 
Administrator----
    Senator Roberts. Well, there are several models, and you 
are working on yours. I am just--can you give me a time frame 
of those 86--I would imagine there are 10 to 12 on the edge. If 
we could just get some certainty and predictability, that is 
really what I am asking for.
    Secretary Azar. So the big change, the one that I am very 
supportive of, and I know you have been supportive of, the one 
you mentioned around critical access hospitals, boosting 
payments and allowing them to focus as emergency hospitals and 
not have to support the in-patient beds if they are not 
financially viable to them, that would require legislation, not 
models. So that would actually----
    Senator Roberts. I have a bill on it, and I think a bunch 
of people are on it just as well.
    Let me move really quickly. The 96-hour rule. If there is 
anything that I think our rural health care delivery system 
folks out there do not care for, it is that. And that requires 
our critical access hospitals as well to have a physician 
certify in writing for each admission that the patient is 
expected to discharge or transfer within 96 hours.
    On top of the requirement to keep patients' average length 
of stay to 96 hours or less, this is a very burdensome and 
redundant regulation that can force hospitals to transfer or 
turn away patients. That is being done. They could have been 
provided with high-quality care. I know of several situations 
that have happened when a person came in with a diagnosis that 
was not correct, not the fault of the folks there, just the way 
it happened. Obviously, they could not come back in until 3 
days, even though the situation was very dramatic.
    Can you explain the decision process to include this policy 
in the last two budgets, considering the proposal was not 
included in budget requests prior to last year? Last year's 
budget indicated that repealing the decision for certification 
requirement would have zero budget impact. This year the 
request states that the budget impact for this policy is just 
not available.
    So if you could--you know, what happened in the last year 
that accounts for this change?
    Secretary Azar. I do not know the difference in modeling 
there, but thanks to your leadership, our budget does propose 
to get rid of that 96-hour rule. It has all the absurdities 
that you have talked about. And so, we are going to keep 
pushing.
    We want to make sure that providers can spend more time 
with their patients instead of complying with unduly burdensome 
regulations. And one of them includes removing this 96-hour 
physician certification requirement. That is an excess burden. 
I think even as you describe it there, it causes people to tilt 
their head and say, you have to be able to predict before 
somebody can come in exactly how it is going to work?
    So we want to keep working with you to get rid of that.
    Senator Roberts. I really appreciate that. Thank you again 
for doing that good work.
    And, Mr. Chairman, I yield back 30 seconds.
    The Chairman. Before Senator Whitehouse asks his questions, 
for the staff of people who are not here, I need to know if 
there are people coming back. Because we have to let Secretary 
Azar go by 12:30 anyway, but between now and 12:30 there is no 
sense of keeping him here if people do not have questions.
    Senator Whitehouse?
    Senator Whitehouse. Thank you very much.
    Mr. Secretary, I want to raise with you a Rhode Island 
situation that continues to bedevil me. For a while Rhode 
Island has been in kind of a reimbursement hole, with lower 
reimbursement rates than nearby Connecticut and Massachusetts.
    We were not a high-cost reimbursement area. We were already 
under-compensated. Then came October of 2018. In October of 
2018, your CMS Administrator, Ms. Verma, unilaterally undid a 
rule, something called ``the imputed rural floor,'' which made 
our payment discrepancy to neighboring Connecticut and 
Massachusetts worse by 20 to 25 basis points.
    She created this situation where, here in Rhode Island 
[pointing to a map], we have Westerly Hospital at a 1.05, 
roughly, reimbursement rate, and half an hour down the road, at 
Lawrence and Memorial Hospital in Connecticut, 1.3525. Do the 
math. What's the difference between 1.05 and 1.35? It is a 30-
damn-percent discrepancy.
    And if you go over here to St. Anne's Hospital in 
Massachusetts, which is literally 5 minutes from the Rhode 
Island border, they are at 1.28, compared to 1.03. Do the math. 
That is a 25-percent discrepancy.
    And what we got told at the time is, ``Do not worry, there 
is going to be this big reform that is going to smooth it all 
out.'' I feel I was lied to. I do not think there has been any 
sign of this ``reform.''
    And then comes this budget. In this budget, not only is 
there no reform, there is a demonstration project, which is the 
kind of thing that gets put together in 5 minutes overnight 
when you do not have a real plan. And guess what the 
demonstration project has the nerve to say? That it is going to 
be the purpose--here is the language from your budget: ``The 
demonstration aims to reduce sharp differences in the wage 
index and Medicare payments between nearby hospitals.''
    Does that not mean that your organization knows, that Ms. 
Verma knows, that sharp differences in the wage index and 
Medicare payments between nearby hospitals are a bad thing?
    Secretary Azar. So, Senator, I share your anger and 
frustration about these disparities that are very--that are 
impossible to explain simply by geography.
    Senator Whitehouse. This one you created.
    Secretary Azar. In fact, I--I keep--I keep this chart, 
because I do--I do share that concern with you. The way they 
index----
    Senator Whitehouse. Be specific to my question. You do 
agree that sharp differences in the wage index and Medicare 
payments between nearby hospitals, your language, are a bad 
thing. And that is why you want to reduce them?
    Secretary Azar. I do agree.
    Senator Whitehouse. Great.
    Secretary Azar. I would like to work with Congress to get--
--
    Senator Whitehouse. Well, could you please get Ms. Verma to 
undo what she did over a year ago? She unilaterally made these 
sharp differences in the wage index and Medicare payments 
between nearby hospitals worse by a factor of 20 to 25 percent. 
And we were already under-reimbursed. Lifespan Hospital reports 
a $25-million loss in the last fiscal year because of the 
decision that she made.
    You can go to other hospitals with similar patient mixes 
around the country, and they would be making money because of 
the way in which they are reimbursed. We had our reimbursement 
hole unilaterally dug deeper by 20 to 30 percent by your CMS 
Administrator. We were not told the truth about what was going 
on at CMS. We now have this bogus demonstration project coming 
out of no place, as best we can tell, that admits that it is 
wrong to be doing just what she did.
    This is a real consequence for our hospitals. They are in 
real pain as a result of this. And it is tiresome to no end 
that your bureaucracy just sits around doing nothing about 
this, making it worse, actually making a problem that you 
identify as a purpose to solve, deliberately and unilaterally 
worse.
    Secretary Azar. And I--Senator, thank you. I just--I do 
want to say neither of us, the Administrator or myself, has the 
unilateral control over regulations on these policies. But----
    Senator Whitehouse. You did this one. She did. She did it.
    Secretary Azar. Even within the administration, none of us 
has the unilateral control. And the challenge with the wage 
index--and you and I, we have had such a good partnership, you 
and I, I enjoy working----
    Senator Whitehouse. I do not blame you. I blame her. I want 
you to fix it.
    The Chairman. Senator Cassidy?
    Senator Cassidy. Hello, Mr. Secretary. How are you?
    The antibiotic market is your wheelhouse as a person very 
familiar with the challenges in the pharmaceutical industry. We 
have these very resistant organisms, and you want to have an 
antibiotic that covers them, but you are going to use it on 
very few people. And most of the people whom you use it on are 
either on Medicare or Medicaid. If you throw in VA, it is going 
to be probably at least two-thirds, maybe four-fifths public 
payers.
    One idea has been to carve out these extraordinarily 
important but rarely used antibiotics from the DRG and to put 
them into Medicare Part B, but making sure you had the 
accountability associated with the stewardship program.
    Knowing that we may end up saving money if you have a 
shorter hospital stay--and of course lives if you have a more 
effective antibiotic--any thoughts about that? And maybe you 
cannot be official, but just because of your expertise?
    Secretary Azar. No, you actually put your finger on exactly 
the problem with antimicrobial resistance in the next 
generation antibiotics that we are developing, and it is 
something that I am actually wrestling with with our team right 
now.
    We have essentially a market failure, as you describe it so 
rightly. We want drug companies to invent an antibiotic that 
will not get used.
    Senator Cassidy. Yes.
    Secretary Azar. That is an economic problem. So I am 
looking at different approaches. One of them could be----
    Senator Cassidy. More properly, it will be used rarely and 
appropriately.
    Secretary Azar. Exactly, as opposed to broadly. One 
approach could be around our payment policies, as you 
mentioned--direct pass-through payments. We--I will look at 
that. The other is, it is increasingly resembling our 
bioterrorism countermeasures programs where the government 
basically is the only purchaser for value of certain products.
    Senator Cassidy. Yes.
    Secretary Azar. It is almost a stockpiling, government 
purchase issue. I have actually commissioned work to look at 
this. We have tools to deal with market failures, and we need 
to look at how those tools could be used here for AMR.
    Senator Cassidy. And I will say that there is at least one 
antibiotic that the United States taxpayer invested hundreds of 
millions of dollars into the development of, and it was sold 
for like $16 million to a company from India because the 
business model did not work. As you say, it is very expensive 
to develop but rarely used.
    Secretary Azar. Right. We have to ensure that there is 
either a commercial marketplace that is viable to sustain 
these, or a government market that will make them sustainable.
    Senator Cassidy. Now, you just said something which of 
course perks my ear up, that you are actually working perhaps 
on a solution regarding this. Now would this solution be in the 
offing? At what stage is this work?
    Secretary Azar. So it is still foundational, so I would 
love to hear your ideas, and we could work together offline 
about that. I have my teams working on this. I have identified 
with some of the recent things you've seen in The Wall Street 
Journal, some of the recent challenges of manufacturers of 
these novel products, and them even not surviving necessarily. 
And it is an economic problem.
    Senator Cassidy. And we will make an appointment to bring 
some ideas in to you, if you do not mind.
    Secretary Azar. Thank you. Thank you.
    Senator Cassidy. Next, another issue I am interested in is 
the mentally ill. Currently they lose their Medicaid when they 
go into a jail setting. And so, even before they are 
adjudicated, they lose their Medicaid. Now if they are on a 
mood stabilizer, for example, that works for them but is not on 
the jail formulary, they may get either not placed on 
something, or placed on something inadequate, and then they 
decompensate, and their behavior worsens, or when they are 
released they are now kind of wandering on the streets as 
opposed to holding a job and paying taxes.
    I think the budget--the administration's budget allows them 
to continue coverage for 6 months while in jail, but I would 
ask, since the definition of a jail is that you stay there 
until you are adjudicated, basically, and that can be up to a 
year, why not extend it for an entire year? And if not for the 
entirety of the Medicaid coverage of care, at least for the 
mental health issue? I think that would go a long way to 
addressing the revolving door of the mentally ill going in and 
out of jail with disruption of care.
    Any thoughts on that?
    Secretary Azar. So it is an important question. We were 
able to get in the budget this year this prohibition of States 
terminating Medicaid coverage for the first 6 months of 
incarceration and requiring that process to facilitate the 
enrollment on release, so that we can avoid relapse and other 
health crises. So we got that far.
    But you raise an important issue about whether one should 
go further. I am happy to work with you on that. I share the 
concern around serious mental illness and incarceration, and 
that transition, that handoff, both in the incarceration as 
well as the handoff from incarceration out to community 
integration.
    Senator Cassidy. Yes. There is at least some suggested data 
out of Los Angeles that the mentally ill are cycling through 
jails. And to the degree that we stabilize that, I think, is 
the degree to which we begin to fundamentally address the issue 
of homelessness.
    I yield back, and thank you.
    The Chairman. Senator Warner?
    Senator Warner. Mr. Chairman, Mr. Secretary, great to see 
you.
    I am going to start on a question that has already been 
asked, but I want to give a slightly different frame on that, 
and that is the Medicaid Fiscal Accountability Regulation. Let 
me acknowledge on the front end, I get the goals of 
transparency, and I get the goals also that perhaps not 
everybody comes with fully clean hands. This has been a 
challenge that has been going on for some time.
    In Virginia, where we finally expanded Medicaid a year ago, 
we have 375,000 people who have gained access to health care--
critically, critically important. I absolutely agree with the 
bipartisan letter of the National Governors and the former 
Governor, myself.
    I really want to make sure--you said you will work with the 
States. But, as you are probably aware, all States are going 
through the budgeting process right now. And the way I read 
this regulation is, it could potentially come out sometime 
later this year and dramatically affect Medicaid eligibility 
and the payment plans that are in place.
    And that will wreak havoc in budgets, red States and blue 
States, all across the country. So I hope that you will also 
commit to working to make sure that we work with the States, 
but we do so to make sure that we limit the impact. Because 
this regulation will not be, I do not think, finished by the 
time most States have actually put forward their budget--and 
they are actually a little bit better than we are in terms of 
meeting their deadlines. They will mostly be done by mid- to 
late-spring.
    Secretary Azar. Yes. So we understand the changes that 
would be implicated here. I want to be fair and equitable, and 
we understand also the budget cycles of States and commit to 
working with the States to be reasonable in our approaches.
    You know, not every State has these improper 
intergovernmental transfers. Some of this is transparency to 
even identify what is going on to make sure real money is being 
spent in the program. And we will work with States also to help 
them design ones that are compliant. In the future, we are 
going to try to be very reasonable. These are our partners in 
this program. We are in this together. We are not trying to cut 
Medicaid through the MFAR regulation. It is just to try to make 
sure it is the right kind of spending.
    Senator Warner. There are--having visited with some of the 
Governors--there are grave concerns, candidly, that that is 
part of the role of the administration, and I hear this from 
both Democratic and Republican Governors. And I think it is 
reflected a little bit in the President's budget.
    So I hope you will--you know I am going to be following 
this very, very closely. And if there is a new systemic 
approach to this that allows everybody to bring a little 
cleaner hands, I get it.
    Let me move in my 2 minutes left to your interoperability 
rule. I think we talked about this at one point. I think one of 
the grave mistakes--again, when there was large bipartisan 
agreement, the one piece around Obamacare was, you know, we 
need to move to EHR. We need to make sure we have better use of 
the data. And one of, I think, the major mistakes that we did 
make is, we spent all that money without any interoperability. 
My background was in cellphones. We would have never had a 
wireless industry in America if we had not required 
interoperability between systems.
    So I support the effort. But we have also seen, in the 
years since it has been put in place, the privacy, 
cybersecurity concerns, the vulnerabilities of this approach 
that we have really got to be thoughtful about. And I, frankly, 
do not believe--you know, I took great exception to your CMS 
Administrator who said that, you know, technology companies are 
doing a good job of protecting this information.
    I do not think that they are. It is not just the Equifaxes 
of the world that are grossly screwing up. And I think we have 
seen lots and lots of history amongst the health-care 
providers.
    So I want to make sure you move forward with this ruling, 
but I also want to make sure that consumers have rights, for 
example, to delete information, to have privacy protections. 
How do we make sure, in this last 30 seconds--this is a much 
longer question, and I have other questions for the record on 
this topic--that we get this right and that we do not--I agree 
with you, we are getting to the goal of interoperability, but I 
am really concerned that we are not taking the cyber and 
privacy protections fully into consideration.
    Secretary Azar. So first, thank you for creating the 
cybersecurity caucus. If you would ever like to come see our 
cyber work, we would be very happy to host you with that.
    Senator Warner. One thing I should say is, we have had 
contact with almost all the health-care systems, and you would 
be amazed at how they will acknowledge--and we will share with 
the Department--how unprepared they are.
    Secretary Azar. For hospital and other health-care CEOs, I 
think cybersecurity is probably the number one risk management 
issue for them.
    In the interoperability rules, we absolutely hear you. And 
we want to make sure the patients at the center of consenting 
to disclosure, interoperability use, transfer of their 
information--that is actually core to everything we are doing, 
is patient ownership of their information and that transfer, 
consenting to that.
    So as we work on final rules on interoperability and 
information blocking, that kind of protection and patient 
ownership is the centerpiece of what we are trying to work 
towards.
    Senator Warner. My time is up. I just want to simply say, 
we want to work with you on that, because I think there are 
some very mixed signals coming from the administration.
    Thank you, Mr. Chairman.
    The Chairman. Senator Brown?
    Senator Brown. Thank you, Mr. Chairman. Mr. Secretary, 
welcome. It is good to see you.
    Colorectal cancer is the second leading cause of cancer 
death among men and women combined in the U.S. On top of that, 
the American Cancer Society estimates there will be more than 
100,000 new cases of colon cancer diagnosed just this year.
    The good news is, we can prevent or treat it successfully 
if we catch it early enough. Thanks to the ACA, colorectal 
cancer screenings are considered a preventive service, and as a 
result, they are available at no cost, no co-pay, no 
deductible--another thing that is important in the Affordable 
Care Act, in spite of your boss's efforts to repeal it.
    Unfortunately, due to a glitch in the law, if you are a 
Medicare beneficiary and you get that cancer screening--I know 
you know this issue well--and polyps are removed to prevent the 
potential for cancer, you wake up with a hefty co-pay.
    It does not make sense. It discourages folks from getting 
the life-saving screenings. I say all this because I am 
thankful the President's budget includes my legislative 
proposal to eliminate the unexpected out-of-pocket costs some 
beneficiaries experience when they get the screening. My bill, 
Removing Barriers to Colorectal Cancer Screening Act, ensures 
that preventive colorectal cancer screenings are fully covered 
by waiving the Medicare cost-sharing requirements for 
preventive colonoscopies, even if a polyp or tissue is removed.
    My legislation has 61 co-sponsors--obviously, a lot on each 
side; 339 supporters on the House side. I would like to ask 
publicly, Mr. Secretary, for your commitment to working with me 
and with the chairman and Ranking Member Wyden in getting this 
done.
    Secretary Azar. Well, absolutely. You know--and I wanted to 
thank you, Senator. You were the one who brought this real 
anomaly in the statute to my attention. It is really absurd 
that a senior goes in for a colonoscopy expecting to have no 
co-pay, and if they happen to find a polyp--which is exactly 
what we are screening for--they come out of anesthesia and they 
get a bill, because then it is converted from a screening into 
a procedure.
    So you raised this to my attention, and I have worked to 
champion that. I am just so delighted it is in the budget, and 
we are going to work with you to get this passed.
    Senator Brown. Good. And I thank Chairman Grassley and 
Senator Wyden for their interest too.
    Two other issues, really quickly. At last year's budget 
hearing, I asked you to commit to a number of things related to 
FDA efforts to curb e-cigarette use. When I asked if you would, 
quote, ``commit to reducing nicotine in cigarettes to 
nonaddictive levels,'' you answered, and I quote, ``Absolutely. 
That is the nicotine rule we will be working on.'' You went on 
to say you would be driving forward with the effort to restrict 
flavors in e-cigarettes ``with full vigor''--your words--that 
you would not hesitate to take, again your words, ``more 
aggressive action if necessary to curb youth use.''
    Despite these strong commitments, HHS dropped its nicotine 
reduction proposal from the Unified Agenda. HHS also 
backtracked on its promise to remove all non-tobacco-flavored 
e-cigarettes from the market.
    The final guidance, instead, released last month exempted 
disposable flavored vaping products and flavored e-liquids. 
Thousands of flavors of e-liquids, e-cigarettes remain on the 
shelves. The huge progress we made for 50 years, bipartisanly, 
is in jeopardy because of that.
    Just, if you would, please tell me why has the Department 
decided to cave to the industry and political pressures and 
stepped back from those efforts?
    Secretary Azar. So actually, on the e-cigarettes and 
flavored e-cigarettes, where we ended up was at an even more 
aggressive posture than when we spoke last year about this 
issue, actually requiring that those child-friendly and child-
used flavors come off the market pending PMTA authorization.
    So we actually advanced to a more aggressive posture than 
even when we spoke before. Because at the time, Commissioner 
Gottlieb had only been speaking about site-of-sale restrictions 
there.
    So I want to be very aggressive on this one. February 6th, 
the enforcement date, has hit us. In terms of disposable 
flavored cigarettes, if we see utilization there in 
disposables, a shift into that--we had seen really the pod-
based items with the replaceable charge driving this. If we see 
movement there, we will certainly take enforcement action. 
Nothing has to be set in stone in terms of our enforcement 
policies here.
    We want to keep these away from kids, even as we try to 
make the other products available for adults to move off 
combustibles.
    Senator Brown. Well, I appreciate your answer, and I do 
believe you are sincere and genuine. I also believe there is a 
White House that on Thursdays and Fridays looks like a retreat 
for tobacco executives. But I am so concerned about the 
flavored disposable products that are out there on the shelves, 
and you need to do better, and we need to do better.
    The last point, Mr. Chairman, quickly. The President's 
budget recommends a cut of more than 9 percent to HHS. You can 
claim the budget prioritized spending on direct services, but 
the primary payer of direct services is Medicaid. The budget 
cuts more than $900 billion from this essential program, 
contrary to a presidential promise in his campaign.
    Whether it is the flu, addiction, coronavirus, or another 
public health threat that we do not even know about yet, 
Medicaid is the most important tool States have to prepare for 
the inevitable and ensure that people get care.
    You may also try to argue that the budget is not for 
proposed cuts to Medicaid, but instead to slow the growth rate. 
That does not mean much to the hundreds of thousands of Ohioans 
who get left out.
    Cutting Medicaid by hundreds of billions of dollars will 
cause hundreds of thousands, maybe millions of people to lose 
health care.
    I remember chapter and verse working with Governor Kasich, 
a Republican in my State, to expand Medicaid. That meant so 
much for our State. The President claims to care about 
protecting pre-
existing conditions. His support of the ACA repeal lawsuit, 
combined with his health-care vision in this budget proposal to 
slash Medicaid, all to pay for huge tax cuts for the wealthy, 
just does not work for public health in our country.
    Secretary Azar. Well again, I just want--as we close, I 
just wanted to thank you for your support and work on the 
colorectal cancer issue. I just think that is going to be a 
huge event for patients if we can get this passed out of 
Congress.
    Senator Brown. I guess that means you do not want to say 
much about----
    Secretary Azar. To talk about Medicaid, on the Medicaid 
program, as you--we are reducing the rate of growth from 5.3 
percent to 3.1 percent. In every single year of the budget 
outlook, Medicaid will increase its expenditures. And what we 
tried to do was, we set an allowance there to work with 
Congress together on how we can grant flexibility to States 
related to expansion populations of able-bodied adults, how we 
can control the rates of growth there, and how we can also fix 
the perverse incentive where we favor able-bodied adult 
coverage over kids and pregnant women, and aged, blind, and 
disabled--the traditional Medicaid beneficiaries that we now 
actually prejudice against in the system.
    So that is sort of at the heart----
    Senator Brown. And the last statement, Mr. Chairman. Would 
you, the next time you are at a Cabinet meeting, or the next 
time you see the President--I do not know if he knows he is 
lying about this, or if he is just used to doing it, but would 
you correct him when he says he is supporting the consumer 
protections for pre-
existing conditions? Because he is trying to take them away 
with the Texas lawsuit.
    He tried to take them away legislatively here. And I assume 
it will not change him. He will still go on the campaign trail 
and talk about how he supports pre-existing conditions, but if 
somebody of your stature tells him he is lying, maybe that 
would be helpful.
    The Chairman. Senator Hassan, you have one question, I was 
told.
    Senator Hassan. Yes, sir. Thank you.
    The Chairman. And then we have to have members speak, other 
staff speak up here, because we are going to adjourn this 
meeting. I have to go vote too. Go ahead.
    Senator Hassan. And so do I. And, Secretary Azar, thank you 
again for being here.
    One note: we are already hearing from pediatricians in New 
Hampshire that 1 week after the ban on pods, flavored pods, 
teenagers are already migrating to the disposables. They 
discovered they are cheaper in the bargain.
    So it has taken 1 week for teenage behavior to begin to 
change, and they are still using these devices, and the harm is 
still happening. So I would like to follow up with you on that.
    But the question I had was about transparency and recent 
anti-kickback settlements, because I think it is something we 
could work on together.
    The Department of Justice recently announced a settlement 
with an electronic health records vendor that was paid by 
Purdue Pharma to display inaccurate data to providers so that 
they would unknowingly over-prescribe Oxycontin.
    Patients and providers have to be able to rely on 
electronic health records as a source of accurate clinical 
information. What steps are you taking to keep this kind of 
misbehavior, to put it lightly, this illegal behavior from 
happening again?
    Secretary Azar. So, I just want to make sure I am 
understanding this, because I am not familiar with the 
particular aspects of litigation. Is this an issue where a drug 
company got basically in the electronic medical record, 
essentially an edit in there that coached towards a certain 
product?
    Senator Hassan. Well, no. It prompted physicians to 
prescribe an opioid again to a patient when the patient might 
not otherwise have needed it. So they were overprescribing, and 
the prompt was essentially paid for by Purdue to the electronic 
records.
    Secretary Azar. I would like to get back to you, if I 
could, on this one to make sure that I am correct. But I 
believe we have actually had efforts working with the major EMR 
vendors--Epic, et cetera, Cerner--to try to get them to 
actually put the non-opioids at the top of the list in terms of 
pain medication, so it is not right there.
    But I am happy to----
    Senator Hassan. And this is really about the integrity of 
electronic health records. We have to be able to depend on 
them. Doctors do too.
    There was a second settlement which goes to some of the 
same issues, about making sure that we are policing the drug 
companies correctly. A second settlement announced in January--
a nonprofit co-pay assistance program was found to have taken 
money from the drug company Insys for the sole purpose of 
paying Medicare co-pays for their fentanyl-based pain 
medication. Of particular concern, this nonprofit knowingly 
facilitated access to this highly dangerous drug for off-label 
use.
    We have seen an increasing number of these settlements in 
recent years as drug companies become more sophisticated in 
their efforts to drive over-utilization. One way to protect 
beneficiaries and save taxpayer dollars is to leverage 
transparency in order to identify these illegal relationships 
before they can take hold in the Medicare program.
    So does your department collect data on payments from drug 
companies to nonprofit co-pay assistance programs, or payments 
to electronic health record vendors, that could help identify 
this costly and dangerous behavior in real time?
    The Chairman. Can you give a short answer to that?
    Senator Hassan. I appreciate that, Mr. Chairman.
    Secretary Azar. I do not know for sure what level of 
disclosure there is. Let me check and get back to you on 
whether they submit that to Medicare and Medicaid on the price 
reporting. It may be in that context.
    Senator Hassan. All right; I would love to work more with 
you on it. Thank you.
    And thank you for your indulgence, Mr. Chair.
    The Chairman. Senator Daines?
    Senator Daines. Secretary Azar, thank you for being here 
today.
    Like many of my colleagues, I hear from seniors across my 
home State of Montana who are struggling with high out-of-
pocket costs when it comes to their prescription drugs. And 
that is why I am working across the aisle of this committee to 
lower the cost of prescription drugs and establish an out-of-
pocket maximum in Medicare Part D in order to provide Montana's 
seniors with some badly needed relief.
    I am glad the administration voices support for such a 
proposal in the President's budget. My question, Mr. Secretary, 
is: can you explain how an out-of-pocket cap would affect the 
average senior in Montana?
    Secretary Azar. Thank you, Senator. And thank you for being 
willing to be part of this bipartisan effort on drug prices.
    Let me give you a made-up example--because I do not have 
Betty's actual name--but let us say there is a Betty in Helena 
who uses a drug called Revlimid. This is used to treat multiple 
myeloma. Under the current Medicare Part D benefit, she would 
have to pay $6,350 before she would hit what is called the 
``catastrophic cap'' in Medicare Part D.
    Once she hits that cap, after over $6,000, she is going to 
pay 5 percent on all drug costs after that point, to infinity. 
That can add up to a lot when you are talking about these kind 
of expensive therapies.
    Now, those costs also would be front-loaded in the benefit 
year. So she is going to pay more when she is in deductible and 
the doughnut hole period. She would likely move quickly through 
that deductible period and get to the catastrophic, that 5 
percent.
    Now in the plan, the Grassley-Wyden legislation out of this 
committee that you have supported, that is going to provide two 
important benefits to her.
    First, because of the savings we get from the inflation 
penalty cap, we create a new catastrophic cap at $3,100. And at 
that point, it is a complete cap. She will never pay again for 
drug expense during that year.
    In addition, a critical innovation that has been made is to 
allow her the option of spreading that catastrophic cap over a 
12-month period. She could elect to never pay more than $258 a 
month for her drugs, no matter what her drug expense is. It is 
an incredible out-of-pocket change for the American senior, if 
we can do this.
    Senator Daines. Thank you. It is a great example, and it is 
an important policy that I am going to continue to advocate 
for, certainly in this committee and getting the vote here on 
the floor of the U.S. Senate.
    I want to shift gears and talk about meth for a moment. 
Many States have been hit hard by the opioid epidemic, but in 
Montana we are facing a meth crisis. That is why it has been 
one of my top priorities in Congress to ensure that our 
communities, our families, Indian reservations, law 
enforcement, have the resources they need to help combat meth 
use.
    In fact, I had the Vice President--the Vice President and 
Karen Pence came out to Montana in June to see firsthand what 
is going on when we visited Billings.
    Efforts include, in States like Montana--we need to make 
sure we target these available resources where they are needed 
to prevent drug overdoses. In fact, I am pleased the 
President's budget increases funding for State opioid response 
programs and allows States to use these funds to address the 
abuse of meth in addition to, of course, discouragement of 
opioids.
    My question, Mr. Secretary, is: can you speak to the 
importance of allowing States and tribes to address their 
unique community needs when it comes to combating substance 
abuse and drug overdoses?
    Secretary Azar. Absolutely, Senator. As you said, each 
State is going to be different. Some are facing more of an 
opioid problem, and some are increasingly facing a meth 
problem. In 15 of the 36 States that report overdose deaths by 
drug type, meth use is responsible for more deaths than 
synthetic opioids even.
    Between 2017 and 2018, we have seen a 30-percent rise in 
deaths from methamphetamine. So as you say, it is a very big 
issue. These gangs out of Mexico that brought us so much of the 
opioid crisis, as we have pressured them down on the opioids, 
they have expanded into commercial-grade and commercial-scale 
production and importation of methamphetamine.
    So I was delighted when Congress, in the 2020 
appropriation, allowed State opioid response grant money to be 
used by States also for stimulant methamphetamines. We have 
continued that policy recommendation in our budget for this 
year, that flexibility for States to address meth, to hopefully 
keep it from being the fourth wave of the addiction crisis.
    Senator Daines. And, Secretary Azar, in the time I have 
remaining, I want to thank you also for calling out the Mexican 
cartels. This is the shift that we are seeing in my home State 
of Montana. We are a northern border State with a southern 
border crisis.
    And that is, once upon a time the home-grown meth had 
purities in the 20-, 30-percent range. This Mexican cartel 
meth, as you know, has purities north of 95 percent. So it is 
far more potent. Price has gone down. Distribution has 
increased. And this is why this is the battle that we have to 
fight right now back home as it relates to meth.
    And thank you for your help in that effort. I am out of 
time, and I believe, Senator Lankford, you are up next.
    Senator Lankford. Okay; thank you.
    Secretary Azar, thank you for being here. Thanks for all 
the work. You have done a lot of work to be able to help folks 
have opportunities to get greater health care and greater 
health-care options. I appreciate that very much.
    I want to bring up something that is new that you proposed, 
that my State actually was first in line to be able to engage 
in, and that is the Healthy Adult Opportunity initiative, to be 
able to allow greater flexibility on Medicaid so they can 
tailor it.
    Oklahoma is not the same as Alaska. It is not the same as 
Illinois. It is not the same as New York. And so, allowing some 
greater flexibility--so where does that stand at this point for 
the Healthy Adult Opportunity initiative?
    Secretary Azar. So we have put the guidance out to the 
States and are now really open to working with States. I think 
it is very important to remember, because a lot has been said 
about this opportunity for States to apply for this 
flexibility, this would preserve--the insurance would have to 
cover essential health benefits. No individual would be deemed 
ineligible. The eligibility requirements for the Medicaid 
expansion under the Affordable Care Act would remain. There 
would not be other partial expansion or partial de-expansion.
    So this really would be for States to come up with ways in 
which they can provide a more integrated approach for these 
able-bodied adults. This is the expansion population, not 
traditional Medicaid that is subject to this--and again, only 
if the State wishes to be doing this.
    Senator Lankford. Right. Somebody in my State is currently 
exploring being able to go through that process.
    You have also put out some proposals on Part D generic 
tiering to allow, basically, a secondary preferred specialty 
tier for drugs to try to get better benefits out there.
    If there is any recommendation I can make on that, it is 
that we continue to be able to lean in on that, and to be able 
to target generics and biosimilars to be able to make sure it 
is not just a benefit across the board, but it is really a 
benefit to those folks who are the consumers, who are the 
purchasers.
    Where does that rule stand at this point? And what are your 
thoughts on that?
    Secretary Azar. So we have proposed that, as part of the 
Part D regulations, to allow the drug plans to have this second 
tier for specialty drugs. Those are the more expensive drugs--
--
    Senator Lankford. Right.
    Secretary Azar. The specialty tier right now may be around 
$660 a month that triggers that. Right now, the regulations 
actually somewhat disable the insurance companies from 
negotiating bigger discounts from pharma because it has just 
the one tier.
    This proposal would allow there to be a more favorable 
tier--so not more restrictive for patient access, but a more 
favorable one to entice drug companies to give even more 
discounts in order to secure access to that tier. And it would 
lower cost-sharing for the patient.
    Senator Lankford. It is one of the things that several of 
us on this committee are working through right now to provide 
multiple tiers and some other options for that, and block some 
of the companies that are preventing drugs from going on the 
generic tier and pushing them onto the higher-priced tier. That 
is something we are trying to work out legislatively.
    Several of us have mentioned things about the rural 
hospital relief. My State has seen seven rural hospitals that 
have closed of late. This is a big issue. Senator Durbin and I 
are actually working on some legislation dealing with critical 
access hospitals, and getting greater flexibility there.
    I know you are also, in a regulation, trying to deal with 
that as well, to allow them to be out-patient, emergency 
hospital access, and that critical access. Where does that 
stand at this point?
    Secretary Azar. So I am actually very happy that it is in 
the President's budget this year to have Congress authorize us 
to allow that kind of flexibility so that a critical access 
hospital could have emergency function, out-patient, but not be 
subject to all the requirements of in-patient.
    In addition, the budget proposes that we would have 
enhanced payments for those critical access hospitals that 
would elect for emergency, so they could be reimbursed at the 
regular emergency rate as well as a supplemental amount of 
payment for them.
    Senator Lankford. Right. Well, we look forward to getting a 
chance to be able to walk through that, because that will be 
very important for all of us in rural States. And Senator 
Durbin and I will continue on with our legislation, trying to 
be able to solve this legislatively long-term.
    The University of Vermont Medical Center made a decision to 
have a nurse during an elective abortion be forced against her 
conscience to be able to participate in the abortion, even 
though there were other nurses who were available and willing 
to do it. She was compelled to participate, that against her 
conscience.
    Your team has reached out to the University of Vermont 
Medical Center and has made requests of them to be able to find 
out where they are, what their standards are. It has been 
months on that.
    Has there been a response back in that process?
    Secretary Azar. So as you know, we--with any of these cases 
in our Office for Civil Rights, we try to actually work towards 
resolutions that bring them into compliance.
    The University of Vermont Medical Center refused to work 
with us on that. And, reluctantly, we had to issue a Notice of 
Violation in order to try to get their attention. Where things 
stand now--because that is a law enforcement matter, I could 
not go into detail about the back-and-forth on that. But the 
critical issue is, we try to work with providers so that they 
commit to bring themselves into compliance.
    Senator Lankford. Right. Well, we will continue to watch 
for that and to see what we can do.
    One last quick question is dealing with nicotine levels in 
vaping. There is not a standard level of nicotine. Obviously, 
several of the vaping devices choose to have very, very high 
levels of nicotine, which they know is the most addictive 
portion of this. The scenario that we have raised to FDA 
before, the year before, is to ask, is there a way to get a 
standard for nicotine so that these devices do not 
intentionally load them up with high levels of nicotine to 
increase addiction?
    Where does that stand?
    Secretary Azar. So there is not a regulation under the 
PMTA. That is the authorization process for e-cigarettes that 
we have for novel tobacco products, a regulation setting a 
nicotine level. But in the course now of the May 2020 deadline 
that the court has set for these e-cigarettes to come in and 
apply for approval or authorization under the PMTA, looking at 
appropriate nicotine levels will be one of the factors that we 
can examine at FDA in determining if an e-cigarette's entry 
into the marketplace is supportive of furtherance of the public 
health.
    So that would be one of the criteria that we can look at 
for the nicotine level.
    Senator Daines [presiding]. Senator Cortez Masto?
    Senator Cortez Masto. Thank you.
    Secretary Azar, thank you for being here; so appreciated. 
Like my colleagues, many of us are concerned about the cuts to 
Medicaid. Similar to what I have heard earlier, in the State of 
Nevada we are one of the States that, thanks to the Affordable 
Care Act, was able to expand Medicaid.
    And many, like this young gentleman here--Alex Cambaris, 
who is 28 years old--are alive today because of Medicaid. My 
concerns are similar to what you have heard from my colleagues.
    One, why are we making these cuts to Medicaid? Most 
importantly, why are we pitting vulnerable groups against one 
another? And how can you make those decisions to decide what 
life to save and what life not to save? Those are the concerns 
you are hearing from us to this administration.
    But let me take this even further. I am also concerned 
about what I have seen happening in Indian country. And let me 
put this on your radar, because I know there is some good work 
that is being done, but I do not think people appreciate the 
impact that the ACA has had on Indian country.
    The law designates IHS as the payer of last resort, helping 
stretch those dollars further. Medicaid expansion, the premium 
tax credits, have boosted coverage and care quality and enabled 
IHS to collect reimbursements that have allowed them to hire 
more providers and specialists. It has helped them to ensure 
that their facilities meet all required standards, including 
those required for ongoing accreditation, or to undertake any 
needed maintenance such as repairing roofs and heating systems.
    The reality is that we know, right now in a court of law, 
this administration is trying to repeal and take away the 
Affordable Care Act, including coverage for pre-existing 
conditions. That is the law. That is what is happening. That is 
reality. It is not conceptual; it is reality.
    And if that happens, I guess my question to you is: what 
happens to Indian country? How do we address their needs if we 
take away the Affordable Care Act? If we take away coverage, 
what are we going to do to help them move forward and continue 
to have access to care?
    Secretary Azar. So again, in terms of the litigation 
position, this has now been sent back to the District Court for 
a searching analysis, provision by provision. This is going to 
take a considerable time, go back to the Fifth Circuit, and 
then maybe the Supreme Court eventually. So this is a rather 
remote item.
    And this point----
    Senator Cortez Masto. Well actually, let me stop you there, 
because I am an attorney. I was an Attorney General for 8 
years. I know what litigation is about. And when you go into 
litigation, you are setting forth your values and your 
principles as part of that litigation.
    So this administration has clearly said they think it is 
unconstitutional, and they want to take away the Affordable 
Care Act and pre-existing conditions, no matter how long it 
takes through that course of litigation.
    You cannot sit here and tell me today that the 
administration's position is that they support the Affordable 
Care Act and they want to keep that coverage and pre-existing 
conditions. So do not try to walk around it somehow by saying 
this is going to be prolonged, so we do not care--it does not 
really matter right now.
    It does matter. That is what this administration values, 
and it sets it out. And the American public needs to know that. 
So please do not start with that.
    My concern is, if it is taken away right now--let us assume 
there is a ruling and it is taken away; what are we doing for 
Indian country?
    Secretary Azar. It is not going to be taken away right now. 
That cannot happen. And unless you decide to work with us on 
reforming or----
    Senator Cortez Masto. So I get that. So tell me, if it is 
taken--listen, let us speculate. Hypothetical. If it is taken 
away, what do we do for Indian country? What is the Plan B?
    Secretary Azar. So this administration actually has had 
historic funding for Indian country and Indian Health Service. 
So we have actually increased the budget by 10 percent since 
fiscal year 2018. We have an additional 3 percent in 2021.
    We are making critical investments in the Indian Health 
Service. We have put $85 million in this budget into quality 
improvement programs. We actually have created the first-ever 
quality office within IHS trying to bring better outcomes.
    What I am trying to drive is--and I hope we will get 
Admiral Weahkee confirmed as our IHS Director--I want to bring 
a complete quality, safety, cultural transformation within the 
Indian Health Service. We owe this to Indian country to deliver 
the finest quality service to our beneficiaries there, and it 
is not just about getting various facilities to meet their CMS 
certification, which of course is a baseline, but it is 
actually, rather, quality that is ingrained in the culture and 
every aspect of what we do in the organization.
    That is a part of what we are doing in our budget, but 
also, what Admiral Weahkee will bring, I hope, if confirmed as 
the IHS Director.
    Senator Cortez Masto. Good. Because I agree with you, and I 
have had conversations with the nominee. I think he is the 
prefect person for the job, and I think we have to work 
together to really address the needs of Indian country.
    So I am glad to hear you say that, and I look forward to 
working with you on those issues.
    Another area that I talk about is Alzheimer's research. In 
2018 the President signed into law the BOLD Infrastructure for 
Alzheimer's Act. It was a bill that I co-sponsored. And it 
actually takes a public health approach to Alzheimer's by 
tasking the CDC with overseeing preparedness and surveillance 
associated with the disease.
    In December, Congress funded the BOLD Act grants, and the 
CDC is now getting ready to send that money out to States and 
local centers of excellence. Those funds are going to support 
Alzheimer's intervention focused on increasing early detection.
    This budget, in my understanding, proposes to discontinue 
CDC's work on chronic disease management and instead tasks 
States with that work using the new America's Health Block 
Grant.
    It does not appear to include Alzheimer's activities, so I 
guess my question to you is, does it?
    Secretary Azar. So the America's Health Block Grant would 
actually create flexibility to States to fund the areas of 
highest concern. Right now, CDC's chronic disease programs are 
very siloed, micro-managed by this area, this area, this area. 
The America's Health Block Grant, if adopted by Congress, of 
course would grant flexibility for States to go where they find 
the greatest need; for instance, perhaps Alzheimer's 
surveillance, as you are talking of, through that program.
    Senator Cortez Masto. Okay, so----
    Secretary Azar. I believe that is correct. If I am making--
--
    Senator Cortez Masto. If I could, because we have been 
fighting for this funding, and I just want to make sure, 
pursuant to the Act, that the money is still going in and being 
targeted by the CDC. That would be very, very helpful. I 
appreciate that.
    Thank you for being here.
    Senator Daines. Senator Wyden?
    Senator Wyden. Mr. Secretary, we have a vote on, so you can 
count on my being really brief. I am going to try to see if I 
can cover two things very quickly.
    As you know, I have been strongly opposed to the Department 
allowing taxpayer-funded faith-based foster care agencies to 
refuse to work with otherwise qualified parents because they 
are Jewish or Catholic. Eight months later, your department 
expanded this taxpayer-funded discrimination in announcing it 
would allow all of your funded grantees to deny services to 
people on the basis of sex or religion.
    So now, not only could vulnerable kids in the foster care 
system be denied access to qualified and loving parents, an 
early childhood center could turn away a child from their 
program because that child's parents are Jewish--or LGBTQ 
people could be refused domestic violence services, and you can 
go on and on.
    How can you claim that this is protecting the religious 
liberty of Americans?
    Secretary Azar. So first, we believe all individuals should 
be treated with dignity and respect, whether it is in our 
health-care programs or our human services programs. That 
should be our expectation of every aspect of our programs.
    But we also enforce discrimination laws that are passed by 
Congress, and we want to vigorously enforce those. The 
regulation that you mentioned was promulgated, really singling 
out one particular Supreme Court case imposing that as an 
obligation and also, violating, or at least risking the 
violation of the Regulatory Flexibility Act in its 
implementation.
    And so, we did not feel we could enforce that. We have a 
proposed regulation out that would require our grantees to 
comply with all Supreme Court case law, not singling one 
particular rule out, and also require compliance with the anti-
discrimination laws as passed by Congress.
    But at our core, we believe everybody should be treated 
with respect in our health and human service programs.
    Senator Wyden. All I can tell you, Mr. Secretary, is, as I 
read the law, you went from essentially a pilot project to 
saying that all HHS-funded grantees could deny services to 
people on the basis of sex or religion.
    I think that is a horrendous precedent for this department 
that is so important to people. And we are not going to get 
parents that we need for these foster care programs.
    Let me ask you about one other thing, and that is, as you 
know, I have felt very strongly that we are in the middle of an 
enormous transformation in the Medicare program. Back when I 
was director of the Gray Panthers, it was about acute care. Now 
it is about chronic disease--cancer, and diabetes, and heart 
disease, and strokes. And here in this committee--Senator 
Daines will certainly remember this--we passed, on a bipartisan 
basis, the CHRONIC Care Act, which took a number of 
constructive steps.
    It helped the Medicare Advantage programs. It helped 
technology, telehelp programs. And you could have programs, for 
example Medicare Advantage programs, be able to pay for safety 
bars in a bathroom for those at risk of a fall.
    My question to you--because time is so short--is, what can 
you tell us is being done to make sure that this program gets 
extended to traditional Medicare? Because as you know, that has 
been an area where we said, look, there is a lot more to do. 
But the future of Medicare is not what I was dealing with when 
I was director of the Gray Panthers: broken ankles. The future 
of Medicare is cancer, diabetes, heart disease, strokes, and 
people who have two or more of these conditions.
    So what is being done to address traditional Medicare and 
expand services there?
    Secretary Azar. Absolutely. So with the CHRONIC Care Act 
that you led, it is a really important advance in thinking 
about Medicare for chronic care and also thinking about 
telehealth as part of that.
    I would say, actually longer-term in traditional Medicare, 
this is where I would encourage you to look at what we are 
doing at the Center for Medicare and Medicaid Innovation around 
direct contracting for total cost of care.
    If we can get providers, whether integrated systems or 
primary care providers--and the applications are due very 
soon--if we can get them to actually assume total cost of care, 
we can get out of micro-managing them on the procedures, the 
individual procedures. Instead, paying for that longer-term 
outcome and them having the financial upside of effective, 
long-term management, I believe long-term that is what causes 
the investments in real chronic care management like what you 
are talking about.
    They may decide--because they will have skin in the game--
to put the bar in the bathroom, for instance, or the ramp at 
the house, or the air conditioner to lead to a better long-term 
chronic care outcome, because they will actually have skin in 
the game.
    Senator Wyden. Let us do this. What you are talking about 
sounds constructive to me. If you could, for the record, give 
us a brief report about what the Department has done since you 
all took office there, and what are the projects that you plan 
to do in the next year, I think that would give us a little 
something to point at.
    You have always taken my calls to discuss this, and I look 
forward to working with you. Thank you, Mr. Chairman.
    Senator Daines. Senator Wyden, that was a very uplifting 
finish to the hearing.
    Senator Wyden. There we are.
    Senator Daines. That is good. Thank you, Secretary Azar, 
for your attendance and participation today. I ask that any 
member who wishes to submit questions for the record please do 
so by close of business Thursday, February 27th.
    With that, the hearing is adjourned.
    [Whereupon, at 11:43 a.m., the hearing was concluded.]

                            A P P E N D I X

              Additional Material Submitted for the Record

                              ----------                              


        Prepared Statement of Hon. Alex M. Azar II, Secretary, 
                Department of Health and Human Services
    The President's Fiscal Year (FY) 2021 Budget is built around a 
vision for HHS and a vision for American health care. We are building 
toward a future where HHS's programs work better for the people we 
serve; where America's health-care system is affordable, personalized, 
and puts patients in control; and where our human services programs put 
people at the center.

    The budget reflects the administration's commitments to delivering 
on this vision and other important themes of HHS's work: advancing a 
patient-centered health-care system, protecting the lives of the 
American people, promoting independence, and making HHS the healthiest 
organization it can be.

    Over the past year, under President Trump's leadership, the men and 
women of HHS have delivered remarkable results. Beginning in 2018 and 
through 2019, the number of drug overdose deaths in America began to 
decline for the first time in nearly 2 decades, thanks to huge 
expansions, assisted by HHS, in access to evidence-based addiction 
treatment. The Food and Drug Administration (FDA) approved a record 
number of generic drugs and biosimilars in FY 2019. We launched new 
payment models in Medicare that pay for health and outcomes, rather 
than sickness and procedures. We finalized a requirement, effective 
January 2021, that hospitals provide patients with useful price 
information, and proposed measures to give patients control over their 
own health data through interoperability. We launched President Trump's 
initiative to end the HIV epidemic in America within 10 years, and 
worked with Congress to secure funding for it. The Department played a 
vital role in responding to an Ebola outbreak in the eastern Democratic 
Republic of the Congo and the humanitarian crisis in Latin America. We 
took unprecedented steps to expand access to treatment for Americans 
with serious mental illness and worked to help seniors remain in their 
homes. The latest data from the Administration for Children and 
Families shows a record number of adoptions with child welfare agency 
involvement, and reductions in the number of children entering foster 
care. The budget proposes to continue work on these priorities, while 
also identifying new areas for action, such as maternal and rural 
health.

    The budget proposes $94.5 billion in discretionary budget authority 
and $1.3 trillion in mandatory funding. Within our discretionary 
programs, it prioritizes funding for programs that have demonstrated 
effectiveness, proposes to end programs that have not, and focuses on 
direct services provided to the American people. On mandatory spending, 
the budget proposes commonsense reforms that will pave a path to fiscal 
sustainability and make these important programs work better for the 
people they serve.
                    facilitate patient-centered care
Providing Price and Quality Transparency
    President Trump's executive order on Improving Price and Quality 
Transparency in American Healthcare to Put Patients First directs HHS 
to make health-care prices transparent, laying the foundation for a 
patient-driven and value-based health system. HHS has acted swiftly to 
require hospitals to publish the prices they negotiate with insurers 
and is working to do the same for issuers, so patients can understand 
their own out-of-pocket costs. CMS has also required Part D 
prescription drug plans to develop tools that allow beneficiaries to 
determine plan benefits and formularies.

    The executive order calls for the development of a Health Quality 
Roadmap that aligns and improves reporting on data and quality measures 
across Medicare, Medicaid, the Children's Health Insurance Program, and 
other Federal health programs. The Roadmap will include a strategy for 
establishing, adopting, and publishing common quality measures; 
aligning hospital inpatient and hospital outpatient measures; and 
eliminating low-value or counterproductive measures.

    HHS legislative proposals increase price and quality transparency 
in Medicare. For instance, the budget would eliminate coinsurance or 
copayments for a screening colonoscopy when a polyp is found, saving 
lives and supporting the President's policy to reduce out-of-pocket 
costs for this common procedure.

    The budget also invests funding in programs that promote 
transparency. The budget requests $51 million for the Office of the 
National Coordinator for Health IT, which includes funding to develop, 
promote, and adopt common standards to integrate health information and 
product transparency while protecting privacy. In addition, the new 
National Institute for Research on Safety and Quality within the 
National Institutes of Health (NIH) supports the administration's 
efforts to move health-care organizations from volume to value by 
focusing on improving outcomes, reducing cost, and expanding choices 
for consumers. Research investments will focus on developing knowledge, 
tools, and data needed to improve the health-care system.
Lowering the Cost of Prescription Drugs
    The United States is first in the world in biopharmaceutical 
investment and innovation. But too often, this system has not put 
American patients first. We have access to the greatest medicines in 
the world, but access is meaningless without affordability. The budget 
supports quick congressional action to pass comprehensive legislation 
to address these flaws in our current drug pricing system and provide 
needed relief to the American people.

    The budget delivers on President Trump's promise to bring down the 
high cost of drugs and reduce out-of-pocket costs for American 
consumers by pursuing policies that align with the four pillars of the 
President's American Patients First Blueprint: increased competition, 
better negotiation, incentives for lower list prices, and lowering out-
of-pocket costs.

    The budget includes an allowance for bipartisan drug pricing 
proposals. The administration supports legislative efforts to improve 
the Medicare Part D benefit by establishing an out-of-pocket maximum 
and reducing out-of-pocket costs for seniors. The administration also 
supports changes to bring lower cost generic and biosimilar drugs to 
patients. These efforts would increase competition, reduce drug prices, 
and lower out of pocket costs for patients at the pharmacy counter.

    The budget includes an allowance for savings of $135 billion over 
10 years to support the President's commitment to lower the cost of 
prescription drugs.
Protecting and Improving Medicare for Our Nation's Seniors
    Over 60 million American seniors are in the Medicare program, and 
they are overwhelmingly satisfied with the care they receive through 
traditional Medicare and Medicare Advantage. The President is 
continuing to strengthen and improve these programs.

    The budget continues to implement the President's executive order 
on Protecting and Improving Medicare for Our Nation's Seniors, building 
on those aspects of the program that work well, while also introducing 
market-based approaches to Medicare reimbursement. The administration 
seeks to protect and reform Medicare with proposals that strengthen 
fiscal sustainability and deliver value to patients. To drive reform, 
the Centers for Medicare and Medicaid Services (CMS) is modernizing the 
Medicare Advantage program, unleashing innovation, expanding telehealth 
options, and driving competition to improve quality among private 
Medicare health and drug plans. The administration is expanding 
flexibility for these Medicare Advantage plans to maximize choices for 
seniors, and taking action to ensure fee-for-service Medicare is not 
promoted over Medicare Advantage.
President's Health Reform Vision Allowance
    While Americans have the best health-care options in the world, 
rising health-care costs continue to be a top financial concern for 
many Americans. President Trump's Health Reform Vision will protect the 
most vulnerable, especially those with pre-existing conditions, and 
provide the affordability, choice, and control Americans want and the 
high-quality care that all Americans deserve.

    The President's Health Reform Vision would build on efforts 
outlined in the executive order, Improving Price and Quality 
Transparency in American Healthcare to Put Patients First to provide 
greater transparency of health-care costs and enshrine the right of a 
patient to know the cost of care before it is delivered. It focuses on 
lowering the price of medicine, ending surprise medical bills, breaking 
down barriers to choice and competition, and reducing unnecessary 
regulatory burdens. The Health Reform Vision will also prioritize 
Federal resources for the most vulnerable and provide assistance for 
low-income individuals. Medicaid reform will restore balance, 
flexibility, integrity, and accountability to the State-Federal 
partnership. Medicaid spending will grow at a more sustainable rate by 
ending the financial bias that currently favors able-bodied working-age 
adults over the truly vulnerable.

    The budget includes savings of $844 billion over 10 years for the 
President's Health Reform Vision Allowance.
Paying for Outcomes
    The administration is committed to advancing a personalized and 
affordable health-care system that puts the patient at the center by 
ensuring Federal health programs produce quality outcomes and results 
at the lowest possible cost.

    In part, this will be achieved by our continued focus on paying for 
outcomes rather than procedures. For instance, the budget seeks to 
improve Medicare primary care services by ensuring payments more 
accurately reflect clinician time, resources, and outcomes. The budget 
also implements a value-based purchasing program for hospital 
outpatient departments, ambulatory surgical centers, and post-acute 
care facilities, offering incentives to improve quality and health 
outcomes. Finally, the budget proposes a set of reforms that improve 
the physician experience and participation in the Quality Payment 
Program by eliminating reporting burdens for clinicians participating 
in the Merit-Based Incentive Payment System, CMS's largest value-based 
care payment program.

    The administration issued proposed rules to modernize key 
regulations that advance the movement to value-based care and paying 
for outcomes. Specifically, the administration proposed reforms to the 
Anti-Kickback Statute, the Physician Self-Referral regulations (Stark 
Law), and 42 CFR Part 2. These proposed rules are part of HHS's 
Regulatory Sprint to Coordinated Care, which aims to reduce regulatory 
barriers and accelerate the transformation of the health-care system 
into one that better pays for value and promotes care coordination. 
These proposed rules reduce unnecessary regulatory burden on physicians 
and other health-care providers while reinforcing their statutory 
intents of protecting patients from unnecessary services, and limiting 
fraud waste and abuse. This includes adding flexibilities with respect 
to outcomes-based payments and part-time arrangements. These rules 
would allow physicians and other health-care providers and suppliers to 
design and enter into value-based arrangements that improve quality 
outcomes, produce health system efficiencies, and lower costs.

    The CMS Center for Medicare and Medicaid Innovation (Innovation 
Center) launched a number of innovative payment and service delivery 
models to test ideas to shift our health-care system toward payment for 
outcomes and health rather than sickness and procedures. This effort 
includes Direct Contracting and Primary Care First, a new suite of 
payment model options that will transform primary care to deliver 
better value for patients throughout the health-care system. In 
addition, the Emergency Triage, Treat, and Transport Model provides 
greater flexibility to ambulance care teams to address emergency health 
care needs of Medicare beneficiaries following a 911 call, rather than 
delivering them to the hospital or emergency department for an 
unnecessary and expensive visit.
                         protect life and lives
Combating the Opioid and Methamphetamine Crisis
    In 2018, drug overdose deaths declined for the first time since 
1990. A reduction in deaths from prescription opioid painkillers is 
almost entirely responsible for this decline. To maintain and build on 
this progress, HHS continues to advance the Department's five-point 
strategy to:

        Improve access to prevention, treatment, and recovery 
services, including the full range of medication-assisted treatments;
        Better target the availability of overdose-reversing drugs;
        Strengthen our understanding of the crisis through better 
public health data and reporting;
        Provide support for cutting edge research on pain and 
addiction; and
        Improve pain management practices.

    The budget requests $5.2 billion to address the opioid overdose 
epidemic and methamphetamine use, including $169 million in new 
resources. Funding expands State Opioid Response grants in the 
Substance Abuse and Mental Health Services Administration (SAMHSA) to 
provide treatment, recovery support services, and relapse prevention. 
The budget provides funding to the Health Resources and Services 
Administration (HRSA) for Addiction Medicine Fellowships to support 
approximately 60 fellows annually in underserved, community-based 
settings that integrate primary care with mental health and substance 
use disorder prevention and treatment services.

    While opioids have been at the forefront of the drug landscape, the 
crisis continues to evolve, and many public health experts believe we 
are entering into the fourth wave of the crisis, which is underscored 
by increases in overdose deaths involving cocaine and methamphetamine.

    HHS is leveraging current efforts to address the opioid epidemic to 
combat the rising mortality and morbidity associated with 
methamphetamines and other stimulants. To allow flexibility to most 
effectively combat substance use in whatever form it takes, SAMHSA's 
State Opioid Response grant program has the flexibility to also address 
stimulants. HHS would direct $50 million within NIH for research to 
develop medication-assisted treatment and evidence-based psychosocial 
treatment for methamphetamines and other stimulants.
Ending the HIV Epidemic: A Plan for America
    In the 2019 State of the Union address, President Trump announced a 
bold new initiative to reduce new HIV infections by 75 percent in the 
next 5 years and by 90 percent in the next 10 years, averting more than 
400,000 HIV infections in that time period. This initiative focuses on 
four key strategies:

        Diagnose all individuals with HIV as early as possible after 
infection;
        Treat the infection rapidly and effectively after diagnosis, 
achieving sustained viral suppression;
        Protect individuals at risk for HIV using proven prevention 
approaches; and
        Respond rapidly to detect and respond to growing HIV clusters 
and prevent new HIV infections.

    The budget invests $716 million in dedicated funding for the second 
year of the Ending the HIV Epidemic: A Plan for America initiative, an 
increase of $450 million from FY 2020. This funding expands activities 
in the 57 target jurisdictions to increase HIV testing and access to 
prevention and treatment services.

    With $371 million, the Centers for Disease Control and Prevention 
(CDC) transitions from planning to implementation and intensifies work 
begun in FY 2020 in the 57 target jurisdictions. CDC grants to affected 
communities will drive additional testing with the goal in the second 
year of doubling the number of new HIV diagnoses rapidly treated with 
antiretroviral therapy to maintain health and prevent additional HIV 
transmissions. Funded jurisdictions will use pharmacy data, telehealth, 
mobile testing, and new science-based networks to ensure individuals 
enter and adhere to care.

    With $302 million, HRSA expands HIV prevention services to all 
community health centers in the targeted initiative areas and serves 
28,000 additional HIV positive people through the Ryan White Program. 
HHS also requests $27 million for the Indian Health Service (IHS) to 
enhance HIV testing and linkages to care for American Indians and 
Alaska Natives.

    NIH directs $16 million to leverage pilot data from 17 Centers for 
AIDS Research to design and evaluate effective, sustainable systems to 
implement HIV prevention and treatment interventions and rapidly 
implement strategies at scale that will be most effective.

    These investments build on ongoing HIV activities supported across 
the Department and an announcement in 2019 to make pre-exposure 
prophylaxis medication available free of charge for up to 200,000 
uninsured individuals each year for up to 11 years. The donation by 
Gilead Sciences, in partnership with HHS, will help reduce the risk of 
HIV infections, particularly for individuals that may be at the highest 
risk.
Improving Maternal Health
    Approximately 700 women die each year in the United States from 
pregnancy-
related complications, and more than 60 percent of these deaths are 
preventable. In fact, women in the United States have higher rates of 
maternal mortality and morbidity than in any other industrialized 
nation--and the rates are rising. In addition to rising mortality 
rates, severe maternal morbidity affects more than 50,000 women and 
adds significant costs to the health-care system.

    Cardiovascular disease is now the leading cause of death in 
pregnancy and the postpartum period, constituting nearly 30 percent of 
pregnancy-related deaths. Chronic hypertension--which is diagnosed or 
present before pregnancy or before 20 weeks gestation--may result in 
significant maternal, fetal, and neonatal morbidity and mortality. The 
rate of chronic hypertension increased by 67 percent from 2000 to 2009, 
with the largest increase (87 percent) among African American women. 
CDC points to hypertensive disorders, cerebrovascular accidents, and 
other cardiovascular conditions as some of the leading causes of 
maternal deaths, all potentially preventable conditions. It is 
imperative to identify risk factors prior to pregnancy in order to 
prevent poor pregnancy and postpartum outcomes.

    HHS's Improving Maternal Health in America initiative is addressing 
this significant public health problem. This initiative focuses on four 
strategic goals:

        Achieve healthy outcomes for all women of reproductive age by 
improving prevention and treatment;
        Achieve healthy pregnancies and births by prioritizing quality 
improvement;
        Achieve healthy futures by optimizing postpartum health; and
        Improve data and bolster research to inform future 
interventions.

    The budget provides a total of $116 million for this initiative 
across the National Institute for Research on Safety and Quality 
(NIRSQ), CDC, HRSA, and IHS. This includes $7 million for NIRSQ to 
improve service data, advance data evaluation, and expand medical 
expenditure surveys to ensure policy makers have timely and accurate 
data. The budget also invests $24 million in CDC to expand the Maternal 
Mortality Review Committees to all 50 States and DC to ensure every 
case of pregnancy-related death is examined. The budget provides $80 
million in HRSA to improve the quality of maternal health services, 
expand access to care, and reduce disparities in care. The budget 
invests $5 million in IHS to help improve health outcomes by 
standardizing care, increasing cultural awareness, and improving care 
for pregnant women.
Advancing American Kidney Health
    Today's status quo in kidney care carries a tremendous financial 
cost. In 2016, Medicare fee-for-service spent approximately $114 
billion to cover people with kidney disease, representing more than one 
in five dollars spent by the traditional Medicare program. In July 
2019, the President signed an executive order launching an initiative 
to transform care for the estimated 37 million Americans with kidney 
disease. The Advancing American Kidney Health initiative tackles the 
challenges people living with kidney disease face across the stages of 
kidney disease, while also improving the lives of patients, their 
caregivers, and family members.

    The budget includes $39 million across multiple HHS agencies and 
requests new legislative authority in support of the initiative's three 
goals:

        Reduce the number of Americans developing End-Stage Renal 
Disease (ESRD) by 25 percent by 2030.
        Have 80 percent of new ESRD patients in 2025 receive dialysis 
at home or a transplant.
        Double the number of kidneys available for transplant by 2030.

    This funding also supports transplantation activities for other 
organs.

    To achieve these goals, HHS is scaling programs nationwide to 
optimize screening for kidney disease and educate patients on care 
options. HHS is also supporting innovation and groundbreaking research 
to inform the next generation of targeted therapies and accelerate 
development of innovative products such as an artificial kidney. New 
and pioneering payment models are also being developed to increase both 
value and quality of care for the patient.

    The budget also targets new funding towards HRSA's Organ 
Transplantation Program to remove financial disincentives for living 
organ donors. The budget invests $31 million in HRSA for the Organ 
Transplantation program, including $18.3 million for the Organ 
Procurement Transplantation Network, Scientific Registry of Transplant 
Recipients, and public and professional education efforts to increase 
public awareness about the need for organ donation. In addition, the 
proposed rule to increase accountability and availability of the organ 
supply--announced in December 2019--would improve the donation and 
transplantation rate measures, incentivize Organ Procurement 
Organizations (OPOs) to ensure all viable organs are transplanted, and 
hold OPOs to greater oversight, transparency, and accountability while 
driving higher OPO performance.

    HHS is working to accelerate innovation in the prevention, 
diagnosis, and treatment of kidney disease through the Kidney 
Innovation Accelerator (KidneyX), a public-private partnership between 
HHS and the American Society of Nephrology. The HHS Office of the Chief 
Technology Officer will continue the KidneyX competition in FY 2021 by 
challenging individuals, teams, and companies to build and test 
prototype solutions, or components of solutions, that can replicate 
normal kidney functions or improve dialysis access.

    The budget proposes to establish a new program within the Office of 
the Assistant Secretary for Preparedness and Response (ASPR) that will 
advance kidney health. The Preparedness and Response Innovation program 
will support advanced research and development, prototyping and 
procurement of revolutionary health security products, technologies and 
other innovations. The program's first project will focus on portable 
dialysis equipment for emergency response. This will ensure that 
individuals with kidney failure have access to dialysis during a 
disaster.

    The budget also advances legislative proposals to revolutionize the 
way patients with chronic kidney disease and kidney failure are 
diagnosed, treated, and supported. This effort includes extensions of 
both the NIH Special Diabetes Program and IHS Special Diabetes Program 
for Indians to address chronic conditions, such as diabetes, that can 
lead to kidney disease.

    For patients who lose Medicare coverage at 36 months post-
transplant and who do not have another source of health-care coverage, 
the costs of continuing immunosuppressive drug therapy may be 
prohibitive. Without these drugs, the patient's body rejects the 
transplant, reverts to kidney failure, and requires dialysis. To 
prevent transplant rejection and reversion to dialysis, the budget 
proposes to establish a new Federal program that provides lifetime 
coverage of immunosuppressive drugs for certain kidney transplant 
recipients until they are otherwise eligible for Medicare coverage. The 
budget also proposes to increase competition among, and oversight over, 
Organ Procurement Organizations to improve performance and increase the 
supply of organs for transplant. In addition, the budget advances new 
innovative kidney care payment models to encourage home dialysis, 
increase access to kidney transplants, and incentivize clinicians to 
better manage care for patients with kidney disease.
Transforming Rural Health
    There are 57 million Americans living in rural communities. Rural 
Americans face many unique health challenges, including hospitals that 
are closing or in danger of closing; difficulty recruiting and 
retaining physicians, nurses, and other providers; and increased 
likelihood of dying from many leading causes of avoidable death such as 
cancer and heart disease.

    HHS's 4-Point Strategy to Transform Rural Health builds on current 
HHS initiatives in the following areas:

        Build a Sustainable Health Model for Rural Communities;
        Leverage Technology and Innovation;
        Focus on Preventing Disease and Mortality; and
        Increase Rural Access to Health Care.

    The budget supports rural communities through programs such as the 
Rural Communities Opioids Response Program and the Telehealth Network 
Grant Program at HRSA, which supports substance use prevention, 
treatment, and recovery services, and promotes telehealth technologies 
for health-care delivery in rural communities. Project AWARE (Advancing 
Wellness and Resiliency in Education) will increase mental health 
awareness training in rural communities. In response to American Indian 
and Alaska Native communities' demand for telebehavioral services, IHS 
expands the Telebehavioral Health Center of Excellence with funding for 
new space, updated equipment, and additional behavioral health 
providers.

    Telehealth services strive to make rural health programs more 
effective, increase the quality of health care, and improve health 
outcomes. The budget seeks to remove barriers to telehealth services in 
rural and underserved areas through a proposal to expand telehealth 
services in Medicare fee-for-service advanced payments models with more 
than nominal financial risk. This proposal broadens beneficiary access 
to Medicare telehealth services and addresses longstanding stakeholder 
concerns that the current statutory restrictions hinder beneficiary 
access. The proposal expands the telehealth benefit in Medicare Fee-
for-Service and provides authority for Rural Health Clinics and 
Federally Qualified Health Centers to be distant site providers for 
Medicare telehealth services. It also permits IHS and tribal facilities 
to be originating and distant site providers, even if the facility does 
not meet the requirements for being located in certain rural or 
shortage areas, and allows for coverage across State lines. The budget 
also proposes to modernize payments to Rural Health Clinics to ensure 
equitable payment for these health clinics and help rural communities 
maintain access to these crucial services. Finally, the budget proposes 
to allow Critical Access Hospitals to voluntarily convert to an 
emergency hospital that does not maintain inpatient beds.
Addressing Tick-borne Diseases
    Tick-borne diseases, of which Lyme Disease is the most common, 
account for 80 percent of all reported vector-borne disease cases each 
year and represent an important emerging public health threat in the 
United States. With 59,349 reported cases in 2017, the annual number of 
reported cases has more than tripled over the last 20 years; due to 
under-reporting, this number substantially under-represents actual 
disease occurrence. The geographic ranges of ticks are also expanding, 
which leads to increased risk for human exposure to the bites of 
infected ticks. Most humans are infected through bites from very small 
young ticks, hosted by deer or mice.

    To address critical gaps in knowledge, diagnostics, and preventive 
measures for tick-borne diseases, HHS is proposing an action plan that 
will prioritize and advance the most promising candidates and 
technologies for diagnosing and preventing Lyme and other tick-borne 
diseases. This plan, led by the Office of the Assistant Secretary for 
Health in partnership with NIH, CDC, and FDA, will address four primary 
areas: innovations in diagnosis and advanced detection, developing 
vaccine-based prevention, ensuring robust domestic surveillance of 
vector borne diseases, and providing additional knowledge to advance 
the best treatment and prevention options. These efforts will improve 
outcomes for those affected by Lyme Disease symptoms. This plan builds 
on the Kay Hagan Tick Act, enacted through the Consolidated 
Appropriations Act for 2020, to improve research, prevention, 
diagnostics, and treatment for tick-borne diseases.

    The budget requests $189 million, an increase of $58 million, to 
address tick-borne diseases. This amount includes $115 million for NIH 
to expand its research on of tick-borne disease, including in the 
prevention, diagnosis, and treatment; and $66 million for CDC to 
address vector-borne diseases, focusing on tick-borne diseases, 
including tick surveillance, insecticide resistance activities, and 
development of improved diagnostics. FDA will ensure the safety and 
efficacy of products developed to prevent, diagnose, and treat vector-
borne diseases.
Focusing on Influenza
    Influenza is a serious disease that can lead to hospitalization and 
sometimes death, even among healthy people. In the United States, 
millions of people are sickened, hundreds of thousands are 
hospitalized, and tens of thousands die from influenza every year. In 
September 2019, the President signed Executive Order 13887, Modernizing 
Influenza Vaccines in the United States to Promote National Security 
and Public Health. The executive order recognized influenza as a public 
health threat and national security priority, and directed HHS to 
prepare and protect the Nation.

    The budget invests $998 million to continue on-going influenza 
activities as well as targeted increases to support this directive. 
This amount includes $306 million for ASPR to modernize influenza 
vaccine manufacturing infrastructure and advance medical countermeasure 
research and development. Activities include additional clinical 
studies on licensure of pre-pandemic recombinant-based influenza 
vaccine and the advanced development of novel diagnostics, respiratory 
protective devices, and alternative vaccine delivery technology. The 
budget also funds the Office of Global Affairs to support U.S. 
leadership of international efforts on pandemic influenza preparedness.

    The budget requests $216 million for CDC's Influenza program, an 
increase of $40 million. CDC will expand influenza vaccine 
effectiveness monitoring systems and develop and characterize candidate 
vaccine viruses for vaccine manufacturers, and efforts to improve the 
evidence-base on non-egg-based vaccines. CDC will support whole genome 
characterization of more than 10,000 influenza viruses. All of these 
activities help build domestic capacity. CDC will also increase 
influenza vaccine use by removing barriers to vaccination and enhance 
communication to health-care providers about the performance of 
influenza vaccines.

    The executive order also calls for the development of novel 
technologies to speed seed vaccine development, targeted development of 
vaccines that protect against multiple types of virus for multiple 
years, and to improve adjuvants. In support of this goal, the budget 
includes $49 million for FDA to support regulatory science research and 
clinical assessments to promote development and access to safe and 
effective influenza vaccines, and $423 million for NIH to accelerate 
influenza research, including universal flu vaccine development.
                         emergency preparedness
    HHS plays a key role in supporting domestic and international 
preparedness and response to ensure our Nation's safety. The budget 
invests $2.6 billion in ASPR to expand efforts to prevent, prepare for, 
respond to, and recover from, the adverse health effects of public 
health emergencies. This amount includes $562 million for the 
Biomedical Advanced Research and Development Authority to maintain a 
robust pipeline of innovative medical countermeasures that mitigate 
health effects of infectious diseases and chemical, biological, 
radiological, and nuclear agents. It also includes $535 million for 
Project BioShield to support procurement of medical countermeasures 
against these threats, and $705 million for the Strategic National 
Stockpile to sustain and increase inventory of high-priority 
countermeasures such as antibiotics to treat anthrax exposure and 
vaccine to prevent smallpox. These investments will help HHS advance 
progress towards national preparedness goals.

    NIH supports a robust research portfolio to develop vaccines and 
therapeutics that enable rapid response to public health threats 
including emerging microbial threats, such as extensively drug-
resistant tuberculosis, emerging viral strains such as Zika, and viral 
hemorrhagic fevers such as Ebola. The budget continues investments in 
NIH in scientific research on these new threats, and invests $120 
million in FDA to facilitate medical countermeasure development and 
availability to respond in the event of a microbial or other public 
health threat.
Strengthening the Indian Health Service
    The administration is committed to improving the health and well-
being of American Indians and Alaska Natives. This population continues 
to experience significant health disparities, and the budget includes 
key investments to ensure quality of care. The budget invests $6.2 
billion in IHS, which includes $125 million for electronic health 
record modernization, provides funding to support IHS Services, Ending 
the HIV Epidemic, and Maternal Health, and includes $125 million for 
high-
priority health-care facilities construction projects. The budget 
proposes a new, indefinite discretionary appropriation and reforms for 
IHS to address Indian Self-
Determination and Education Assistance Act section 105(l) lease costs.
Reforming Oversight of Tobacco Products
    The budget proposes to move the Center for Tobacco Products out of 
FDA and create a new agency within HHS to focus on tobacco regulation. 
A new agency with a mission focused on tobacco and its impact on public 
health would have greater capacity to respond rapidly to the growing 
complexity of new tobacco products. Additionally, this reorganization 
will allow the FDA Commissioner to focus on its traditional mission of 
ensuring the safety of our Nation's drug, food, and medical products 
supply.
Providing Shelter and Services for Unaccompanied Alien Children
    The Administration for Children and Families (ACF) provides 
shelter, care, and support for unaccompanied alien children apprehended 
by the Department of Homeland Security or other Federal Government 
department or agency. The number of unaccompanied alien children 
requiring care is inherently unpredictable. In FY 2019, ACF cared for 
69,488 children, the highest number in the program's history. To ensure 
adequate shelter capacity and care in FY 2021, the budget requests a 
total of $2 billion in discretionary funds to support capacity of 
16,000 licensed permanent beds, depending on operational needs, and 
includes a mandatory contingency fund to provide up to $2 billion in 
additional resources if needed.
                          promote independence
Promoting Upward Mobility
    In the human services work at HHS, the overarching goal is to 
promote personal responsibility, independence, and self-sufficiency--to 
help Americans lead flourishing, fulfilling, independent lives. HHS 
programs for low-income Americans achieve this goal by supporting work, 
marriage, and family life. HHS seeks to better align our social safety 
net programs with the booming economy, and focus on work as the means 
to lift families out of poverty.

    Many Americans are joining the workforce as the administration's 
policies continue to strengthen the economy and produce historically 
low unemployment rates. The administration supports working families by 
investing in child care, an important work support that helps families 
achieve independence and self-sufficiency. The administration is 
working to implement policies that increase access to high-quality, 
affordable child care.

    The budget proposes to improve the Temporary Assistance for Needy 
Families (TANF) program by restoring its focus on employment and work 
preparation, and by targeting funds to low-income families. The 
proposal fundamentally changes the way the program measures success by 
moving to measures that focus on employment outcomes, phasing out the 
ineffective work participation rate. In addition, the budget 
establishes Opportunity and Economic Mobility Demonstrations that allow 
for the streamlining of funding from multiple safety net programs to 
deliver coordinated and effective services. The budget also seeks to 
improve consistency between work requirements in TANF and Medicaid by 
requiring that able-bodied individuals participate in work activities 
at least 20 hours per week in order to receive welfare benefits.
Supporting Child Care
    Child care is an investment in both present and future generations 
of the workforce. However, it is also one of the biggest expenses for 
families and can be a barrier to work. Funding plays a critical role in 
helping families achieve self-sufficiency by providing parents access 
to a range of child care options. In FY 2018, the most recent year for 
which preliminary data are available, over 1.3 million children from 
about 813,000 low-income families received a monthly child care subsidy 
from the Child Care and Development Fund. The budget provides $5.8 
billion for the Child Care and Development Block Grant and $4.2 billion 
in mandatory child care funding for a total investment of $10.0 billion 
in child care. The mandatory funding includes a one-time $1 billion 
fund for competitive grants to States to increase child care services 
for underserved populations and stimulate employer investment in child 
care. The budget will serve 1.9 million children.
Promoting Adoption
    Adoption gives children stability and love during their childhood, 
and also a safe and stable environment in which to grow into 
responsible adults who flourish. Approximately 20,000 youth exit or 
``age out'' of foster care each year without the safety net of a 
forever family, and their outcomes are often concerning. A longitudinal 
study found that only 58 percent graduated from high school, and only 
half found employment by age 24. More than a third of youth in one 
study had experienced homelessness at least once by age 26. Children 
and young adults in foster care cannot be expected to achieve the 
independence they need to thrive and flourish on their own--but finding 
them a loving forever family could change all that.

    According to ACF, the number of children adopted with help from 
public child welfare agencies rose from 59,000 in FY 2017 to more than 
63,000 in FY 2018. To sustain this momentum, ACF has launched a Call to 
Action for States and other stakeholders, which aims to develop and 
sustain key partnerships across public and private groups, including 
faith-based groups, with the goal of reducing the number of children in 
foster care and increasing the number of children who find a forever 
family, through adoption or otherwise.

    The Adoption Assistance and Guardianship Assistance programs will 
provide $4.1 billion in FY 2021 in mandatory funding to provide monthly 
support payments to families adopting sibling groups or other children 
with special needs. Under existing law, Adoption Assistance funding 
will keep pace with the number of qualifying children adopted each 
year.

    HHS promotes adoption through administrative actions and funding 
incentives to promote adoption, and to identify and address barriers to 
adoption. Initiatives include family-finding programs, focusing on 
identifying the barriers that exist in the recruitment and development 
of foster and adoptive families, and the development and dissemination 
of court-related practice improvements addressing barriers to timely 
adoptions.
Supporting Families and Preventing the Need for Foster Care
    Helping families receive the care and services they need before the 
involvement of a child welfare agency can help prevent a child from 
entering foster care. The administration has focused on primary 
prevention, as well as adoption, and we are starting to see better 
results. HHS is implementing the Family First Prevention Services Act 
(Family First Act), which supports services to prevent child 
maltreatment and the need for foster care. This groundbreaking new 
legislation provides the opportunity for substantial improvements in 
outcomes for children and families. The budget proposes to streamline 
the process for evaluating evidence-based prevention services programs 
under the Family First Act to give States and tribes access to more 
programs that help prevent the need for foster care and assist kinship 
caregivers.

    The budget invests $510 million for discretionary child welfare 
activities in ACF, including services that allow children to remain 
safely with their families and education and training vouchers for 
youth aging out of foster care. In collaboration with CMS, the budget 
proposes that Qualified Residential Treatment Programs (QRTPs) be 
exempted from the institution for mental diseases (IMD) payment 
exclusion allowing children in foster care to have Medicaid coverage in 
these placements even if a QRTP qualifies as an IMD.

    The budget provides $197 million to ACF for child abuse prevention 
grants. These grants support increased use of evidence-based prevention 
programs, allowing States to explore new research opportunities and to 
adapt more rigorous evaluations of existing programs; demonstration 
projects to test the effectiveness of partnerships that strengthen 
family capacity and prevent child abuse through the co-location of 
services; and State plans for safe care of infants affected by 
substance use disorders.

    The budget also proposes to expand the Regional Partnership Grant 
program by $40 million each year, which will increase funding for 
grants that help courts, child welfare agencies, and other government 
and community entities work together and improve practices to address 
the impact of substance abuse, including opioids, on child welfare. The 
budget proposes an increase of $30 million each year for the Court 
Improvement Program to help courts improve practices and comply with 
new mandates in the Family First Act.
Strengthening Efforts to Treat Serious Mental Illness and Serious 
        Emotional Disturbances
    In 2018, more than 11 million adults in the U.S. were living with a 
serious mental illness. More than 7 million children and youth 
experienced a serious emotional disturbance. They faced a greater risk 
of suicide and life expectancy 10 years shorter than the general 
population.

    The budget provides $1.1 billion to SAMHSA for serious mental 
illness and serious emotional disturbances, which includes funding to 
support Assertive Community Treatment for Individuals with Serious 
Mental Illness, Community Mental Health Services Block Grant, and 
Children's Mental Health Services. These programs provide comprehensive 
and coordinated mental health services for some of the Nation's most 
vulnerable populations and increases access to mental health services 
in schools. The budget will also provide targeted flexibility for 
States to provide inpatient mental health services to Medicaid 
beneficiaries with serious mental illness.

    The budget also invests in programs that address the Nation's 
alarming rates of suicide. Suicide is the 10th leading cause of death 
in the United States--responsible for more than 47,000 deaths in 2017--
and suicide rates have increased steadily for individuals of all ages. 
The budget provides $93 million for suicide prevention activities, 
including additional funding to expand Zero Suicide initiatives to 
focus on adult suicide prevention and allow communities and States to 
tailor strategies to prevent suicide in their local jurisdictions.
Supporting Independence for Older Adults and People With Disabilities
    The administration prioritizes community living for older adults 
and people with disabilities to ensure that they can maintain 
independence and live fully integrated in their communities. The budget 
invests $1.5 billion in the Administration for Community Living for 
critical direct services that enable seniors and people with 
disabilities to live independently, such as senior meals, in-home chore 
assistance, independent living skills training, employment training, 
and information and referral services. These programs empower older 
adults and people with disabilities to live independently and make 
critical choices about their own lives.
       promote effective and efficient management and stewardship
    HHS is responsible for more than one-quarter of total Federal 
outlays. The Department administers more grant dollars than all other 
Federal agencies combined. HHS is committed to responsible stewardship 
of taxpayer dollars, and the budget continues to support key reforms 
that improve the efficiency of Departmental operations.
Advancing Fiscal Stewardship
    The administration recognizes its immense responsibility to manage 
taxpayer dollars wisely. HHS ensures the integrity of all its financial 
transactions by leveraging financial management expertise, implementing 
strong business processes, and effectively managing risk.

    As the Department overseeing Medicare and Medicaid, HHS is 
committed to exercising proper oversight of these programs to protect 
the millions of impacted beneficiaries and the taxpayers in general. In 
accordance with the direction in the executive order on Improving and 
Protecting Medicare, HHS is investing in the newest technological 
advancements, such as Artificial Intelligence, to enhance our ability 
to detect and prevent fraud, waste, and abuse.

    The Department is committed to reducing improper payments in 
Medicare, Medicaid, and Children's Health Insurance Program (CHIP). HHS 
continues to enhance existing program integrity tools to address 
improper payments and prevent fraud, including provider screening, 
prior authorization, and auditing providers and plans. New methods and 
technologies will allow HHS oversight to reduce improper payments and 
adapt to the changes in health care as we shift from a fee-for-service 
to a value-based health care payment system.

    The budget advances new legislative and administrative proposals to 
strengthen the Department's ability to address weaknesses in Medicaid 
beneficiary eligibility determination processes, while providing tools 
to facilitate the recovery of overpayments made by States. HHS also 
continues to support updates to Medicaid information systems that offer 
critical support to program integrity efforts, including the 
Transformed Medicaid Statistical Information System (T-MSIS) and a new 
Medicaid drug rebate system. In addition, HHS includes proposals that 
enhance oversight of Medicare Advantage and Part D plans, increase the 
period of enhanced oversight on new providers, and expand Medicare fee-
for-service prior authorization.
                       implementing reimagine hhs
    HHS supports the President's Management Agenda through ReImagine 
HHS, the Department's robust reform and transformation effort, 
organized around core goals to streamline processes, reduce burden, and 
realize cost savings. The effort takes an enterprise approach, 
affecting activities across the Department. For example, the Buy 
Smarter initiative plans to use new and emerging technologies to 
leverage the enormous purchasing power of HHS and streamline the end-
to-end procurement process. The Maximize Talent initiative addresses 
modern-day human capital management and human resources operational 
challenges, resulting in key achievements: HHS's simplified recruitment 
process resulted in a significant increase in the number of new hires 
on-boarded since implementation, and HHS was rated the ``Best Place to 
Work in the Federal Government'' out of all executive departments in 
2019. As part of the Bring Common Sense to Food Regulation initiative, 
FDA is working to increase collaboration between food regulatory 
programs to minimize dual jurisdiction and improve State product 
safety. As a result, 48 States and territories participate in the 
Produce Safety Implementation Cooperative Agreement Program, which 
increased State large farm inspections over 400 percent in FY 2019.

    ReImagine HHS efforts are also making HHS more innovative and 
responsive. Under the Optimizing Regional Performance initiative, HHS 
developed a Regional Facilities Utilization Model with $150 million in 
potential savings and a footprint reduction of more than 62 percent 
within 10 years. For the first time since 1974, HHS completed a 
comprehensive assessment of regions to better align with administration 
priorities and improve HHS's ability to serve Americans across the 
country. In addition, under the Optimize Coordination Across HHS 
initiative, HHS configured a new cloud environment for an 
administrative data hub to provide dashboarding capabilities for 
Operating Divisions, bringing together human resources, travel, and 
facilities data to inform better decision-making across the enterprise.

    In FY 2021, all ReImagine HHS projects will reside in their 
permanent offices within HHS. This ensures that their work can 
sustainably continue going forward.
Grants Management
    HHS continues to drive change for grants management government-
wide. Leveraging the efforts and success of the HHS ReImagine Grants 
Management initiative. The Office of Management and Budget pre-
designated HHS as the Grants Quality Services Management Office (QSMO) 
to create and manage a marketplace of solutions for grants management; 
govern its long-term sustainability; institute a customer engagement 
model; and drive the implementation of standards and solutions to 
modernize grants management processes and systems. Guided by a 
government-wide governance board, QSMOs are tasked with offering 
solutions that, over time, will improve quality of service and customer 
satisfaction; modernize and automate processes and supporting 
technology; standardize processes and data; and achieve efficiencies in 
government-wide operations and maintenance.

    In FY 2018, the government awarded over $750 billion in grants to 
approximately 40,000 recipients across more than 1,500 programs.

    Full designation as the Grants QSMO is contingent upon approval of 
a 5-year implementation plan and budget estimate in alignment with the 
published QSMO Long-term Designation Criteria. HHS is developing a 
vision and strategy to inform the Grants QSMO 5-year implementation 
plan, with significant engagement with stakeholders to ensure the 
Grants QSMO can meet their diverse needs.
Regulatory Reduction
    HHS is committed to streamlining the regulatory process and 
evaluating necessary steps to eliminate or change regulations that 
impose unnecessary burden. Burdensome regulations can drive up costs of 
health care, while poorly designed regulations can come between doctors 
and patients, reducing the quality of care and the essential trust to 
that relationship. From FY 2017 to FY 2019, HHS succeeded in cutting 
the economic burden of its regulations by $25.7 billion through 46 
deregulatory actions. HHS had the largest deregulatory impact of any 
Cabinet agency during this time period.

    HHS is using the power of new cognitive technologies for greater 
operational effectiveness and research insights, including regulatory 
reduction. HHS used an artificial intelligence-driven regulation 
analysis tool and expert insight to analyze the Code of Federal 
Regulations, seeking potential opportunities to modernize regulations. 
HHS since launched a Department-wide Regulatory Clean-Up Initiative to 
implement changes based on these findings, by reviewing and--where a 
change is warranted--addressing incorrect citations and eliminating the 
submission of triplicate or quadruplicate of the same citation.

    HHS is working to implement the provisions of the executive order 
on Promoting the Rule of Law through Improved Agency Guidance 
Documents. This executive order will accomplish important policy goals 
that will improve HHS guidance practices in the long term. Prior to the 
issuance of this executive order, several Federal agencies issued 
internal memoranda regarding the appropriate use of guidance. The 
executive order requires agencies to now go a step further and codify 
certain good guidance practices and policies into Federal regulations. 
By August 27, 2020, each agency must finalize regulations to set forth 
processes and procedures for issuing guidance documents. In addition, 
by February 28, 2020, Federal agencies must establish a single, 
searchable database on its website that contains, or links to, all of 
the agency's guidance documents currently in effect. Any guidance 
document not included in the guidance website is deemed rescinded. HHS 
is committed to meeting the President's timelines.

                                 ______
                                 
       Questions Submitted for the Record to Hon. Alex M. Azar II
               Questions Submitted by Hon. Chuck Grassley
    Question. Are there any proposals in the President's budget to 
change how Medicare benefit determination formulae, or to change how 
Social Security retirement of disability benefits are calculated?

    Do proposals in the President's budget aimed at programmatic budget 
savings, relative to the budget baseline, through program integrity 
measures, for example, lead to absolute cuts in Medicare or Social 
Security benefit payments? Or, rather, including projected effects of 
the budget proposals, are Medicare and Social Security benefits 
projected to continue to rise relative to the budget baseline?

    Regarding so-called cuts to Medicare, consider the views of the 
nonpartisan Committee for a Responsible Federal Budget. That 
nonpartisan group says that claims that the President's budget cuts 
Medicare benefits are false and misleading. They also say:

        The President's Medicare proposals would improve the value of 
        each Medicare dollar, reduce the unsustainable growth of the 
        program, and lower costs for seniors and other households. 
        These policies would not represent reductions in benefits, but 
        instead reductions in cost for roughly the same level of 
        benefits. Indeed, the policies would actually reduce costs for 
        individuals by lowering premiums and out-of-pocket costs.

    Reducing costs for individuals is also at the heart of my drug-
pricing bill with Ranking Member Wyden. And I don't view our approach 
as benefit cuts either, and if we all focus on the intent and substance 
of proposals, rather than whether we can make statements for political 
purposes, I think we will all be better off. Do you agree that the 
President's budget proposals would lead to reductions in costs for 
roughly the same level of benefits for Medicare, and not ``cuts to 
Medicare benefits''?

    Answer. Under President Trump's leadership, the administration has 
taken significant steps to improve health-care markets and streamline 
insurance rules. The President's vision for health-care reform will 
further strengthen and protect Medicare, including through proposals 
that extend the solvency of the Medicare Hospital Insurance Trust Fund 
for at least the next 25 years.

    President Trump's 2019 executive order, Protecting and Improving 
Medicare for Our Nation's Seniors, builds on those aspects of the 
Medicare program that work well, including market-based approaches in 
the current system. The budget furthers these goals for the Medicare 
program and saves proposes approximately $756 billion in gross Medicare 
savings over 10 years.

    Question. I've heard some people say that the President's budget 
involves ``cuts'' to Social Security. There are program integrity 
measures in the budget and proposals to test new approaches to increase 
labor force participation, but there are no proposals to change how 
Social Security retirement or disability benefits are calculated, as 
far as I can tell.

    Several of the program integrity proposals in the President's 
budget were also proposed in budgets from President Obama. Things like 
using death data to prevent improper payments. The only things to cut 
there are improper payments.

    President Obama's budgets claimed budget savings from those types 
of provisions, on the order of tens of billions of dollars. Yet, during 
hearings on President Obama's budgets, I didn't hear anyone from either 
side calling them cuts, or claiming that President Obama was out to cut 
Social Security or destroy its programs.

    Instead, I heard that the proposals were designed for program 
integrity. For example, in a hearing before the Senate Finance 
Committee President Obama's fiscal year 2015 budget, which included 
some of the same proposals on Social Security that are in President 
Trump's fiscal year 2021 budget, then-Treasury Secretary Lew said:

        What our budget does is, it lays out a program of program 
        integrity to make sure that people who apply for disability are 
        eligible for it, and we would work together with the kinds of 
        changes we need to protect that critically important program.

    I disagree with people calling things cuts now that they didn't 
call out as cuts when a Democrat was in the White House.

    Are there Social Security program-integrity proposals in President 
Trump's Fiscal Year 2021 budget that are the same or substantively 
similar to any proposed in past budgets by President Obama?

    Do any of the proposals in President Trump's Fiscal Year 2021 
budget entail any changes in how Social Security retirement or 
disability benefits for eligible beneficiaries are calculated that lead 
to cuts in those benefits that are determined by statutory formulae?

    Answer. HHS defers to the Social Security Administration.

                                 ______
                                 
                Questions Submitted by Hon. John Cornyn
                                  mfar
    Question. In November, CMS proposed the Medicaid Fiscal 
Accountability Rule that is supposed to bring greater transparency and 
accountability to the Medicaid program. As you may know, Texas is 
subject to extensive Medicaid reporting requirements under its 1115 
waiver, and the additional reporting requirements in the rule will 
ensure we are protecting taxpayer dollars. But many providers have 
expressed concern that the rule, as proposed, could lead to hospital 
closures, problems with access to care, and threaten the safety net.

    Given stakeholder responses, how is HHS planning to balance the 
need for additional reporting of supplemental payments with timelines 
that prevent undue State burden or access issues for beneficiaries?

    If you move forward with finalization and implementation of the 
rule, what assurances can you provide to make sure substantive concerns 
are addressed?

    Answer. The Medicaid Fiscal Accountability Regulation (MFAR), CMS-
2393-P, was published in the November 18, 2019, issue of the Federal 
Register, with a 60-day comment period that closed on January 17, 2020, 
which was subsequently extended by 15 days and closed on February 1, 
2020. During this time, CMS also conducted numerous calls with States 
and other stakeholders to receive substantive feedback to help us 
understand the potential impact of the proposed rule.

    The policies proposed within the rule are intended to ensure 
accountability of State financing, transparency of payments, and the 
fiscal integrity of the Medicaid program, including through numerous 
clarifications to Medicaid financing and oversight rules. Specifically, 
this proposed rule would impact States' reporting on payment methods 
and procedures to assure consistency with efficiency, economy, and 
quality of care as required by section 1902(a)(30)(A) of the act. CMS, 
and other Federal oversight entities, have found that current 
regulations and guidance do not adequately ensure that States are 
complying with the efficiency, economy and quality of care requirements 
of section 1902(a)(30)(A) of the act, and this proposed rule is 
intended to address those deficiencies. However, we have listened 
closely to concerns that have been raised by our State and provider 
partners about potential unintended consequences of the proposed rule, 
which require further study. Therefore, CMS has withdrawn the rule from 
the regulatory agenda.
                              biosimilars
    Question. There has been bipartisan, bicameral legislation advanced 
this Congress to implement an access measure to incentivize Medicare 
Advantage and Part D plans to improve access to biosimilars on their 
formularies and therefore increase utilization of these lower-cost 
products.

    Has HHS considered pursing this on its own? If not, would you be 
able to look into that and get back to this committee?

    Answer. The administration supports changes to bring lower cost 
generic and biosimilar drugs to patients. Since the administration 
issued American Patients First, its blueprint to lower drug-pricing 
costs, FDA has promoted competition in drugs and biologics, advanced a 
strong framework for biosimilars, and modernized regulatory oversight 
of generic drugs. The administration finalized a policy in which each 
biosimilar for a given biologic gets its own billing and payment code 
under Medicare Part B, to incentivize development of additional lower-
cost biosimilars. Prior approaches to biosimilar coding and payment 
would have created a race to the bottom of biosimilar pricing, while 
leaving the branded product untouched, making it an unviable market 
that few would want to enter.

    Question. Secretary Azar, I appreciate your focus on improving 
access to generics and biosimilars. You previously stated, ``I am very 
much aware of these rebate walls that can prevent competition and new 
entrants into the system. . . . I don't like that practice. I think 
it's using their market power in ways that is not appropriate.''

    Can you explain what you're referencing in this quote--why aren't 
biosimilars penetrating the market?

    Answer. There are a number of reasons why biosimilars have not 
taken off here in the United States. In so many cases, today's rebate 
system not only distorts pricing signals--it also discourages the 
introduction of new competition. Pharmacy benefit managers and payers 
are happy to continue receiving a big rebate on a biologic, rather than 
go to the trouble of covering a biosimilar competitor with not just a 
lower net price, but a lower list price too. What is standing in the 
way of that competition is sometimes referred to as the ``rebate 
wall.'' It is only a good deal for defenders of the status quo, whether 
that's manufacturers selling certain drugs or pharmacy benefit managers 
negotiating big rebates.

    Question. There are proposals in both the House and Senate to 
increase the add-on payments for biosimilars.

    Have you considered a similar approach through CMMI? Or 
implementing 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?

    Answer. We are focused on a long-term solution that increases the 
competitiveness of biosimilar drugs in the Medicare program. One action 
CMS has provided MA plans is the option of applying step therapy for 
physician-administered and other Part B drugs.
              radiation oncology alternative payment model
    Question. Last year, CMMI proposed a mandatory Radiation Oncology 
Alternative Payment (RO-APM) Model to include 40 percent of Medicare 
episodes across 17 cancer types with a bundled payment. The radiation 
oncology stakeholder community is very supportive of value based care 
and worked hard to submit a proposal to CMS before the CMMI proposal 
was released although the community's proposal seems to have been 
largely ignored. I am concerned that the RO-APM proposed by CMMI will 
disrupt patient care and so are radiation oncologists. A paper soon to 
be published in the Radiation Oncology journal, ``Impact of Patient 
Stage and Disease Characteristics on the proposed Radiation Oncology 
Alternative Payment Model (RO-APM) at a Large Academic Cancer Center'' 
found that the RO Model will be detrimental to the care of vulnerable 
populations with complicated cancers that were caught late and 
therefore require care that costs more than the model was designed for.

    Would you be open to amending the proposed RO-APM to ensure that 
the disruption predicted to radiation oncology for our Nation's seniors 
does not happen?

    Has HHS considered a smaller, targeted model to test out the 
bundled payment in radiation oncology to ensure patient care is 
enhanced?

    Answer. CMS is committed to promoting higher quality of care and 
improving outcomes for Medicare beneficiaries while reducing costs, 
including among beneficiaries with cancer. We have undertaken a number 
of initiatives to improve cancer treatment, most notably with our 
Oncology Care Model. We believe that a model in radiation oncology 
would further these efforts to test ways to improve cancer care for 
Medicare beneficiaries and reduce Medicare expenditures. On September 
29, 2020, CMS finalized a new Innovation Center model, the Radiation 
Oncology (RO) Model. The RO Model is expected to improve the quality of 
care for cancer patients receiving radiotherapy and reduce Medicare 
expenditures through bundled payments that allow providers to focus on 
delivering high-quality treatments. The new model creates simpler, more 
predictable payments that incentivize cost-efficient and clinically 
effective treatments to improve quality and outcomes. On October 21, 
2020, in response to feedback from stakeholders, CMS announced that it 
would delay the start of the model to July 1, 2021.

    In response to comments received during the public comment period, 
CMS made the following key changes to the final RO Model design:

        Delayed the start date until July 1, 2021 (from the proposed 
start of January 1st or April 1, 2020).
        Reduced required participation from 40 percent to 30 percent 
of eligible RO episodes annually that are furnished by RT providers and 
RT suppliers located in a random sample of CBSAs. This is the smallest 
possible model size that CMMI could test in order to demonstrate 
statistically significant savings.
        Reduced the discount from 4 percent for the Professional 
Component (PC) of the RO Model payment to 3.75 percent, reduced the 
discount from 5 percent for the Technical Component (TC) of the RO 
Model payment to 4.75 percent; and reduced the incorrect payment 
withhold from 2 percent to 1 percent.
        Reduced the 17 included cancer types in the RO Model to 16 
included cancer types; as kidney cancer is not commonly treated with 
radiotherapy, it does not meet the criteria for inclusion in this 
model.
        Changed to allow the second half of the RO Model payment to be 
made when radiation treatment has ended before the end of the 90-day RO 
episode, but no earlier than 28 days after the initial treatment 
planning service was furnished.
        Revised to allow MIPS adjustments for the professional 
component of the RO Model payment.
        Added an annual opt-out option for low-volume entities, which 
allows any physician group practice, freestanding RT center, or HOPD 
that furnishes less than 20 episodes within one or more of the randomly 
selected CBSAs in the most recent year with available claims data to 
opt-out of the RO Model.
        Added a stop-loss limit of 20 percent for RO participants that 
do not qualify to receive an historical experience adjustment and that 
were furnishing included RT services at the time of the effective date 
of the final rule in a CBSA selected for participation.

    CMS will continue to work with stakeholders to ensure that 
beneficiaries continue to have adequate access to these important 
services, and that providers have the tools and resources they need to 
implement the changes required by the RO Model.
                      strategic national stockpile
    Question. The Strategic National Stockpile (SNS) can make 
purchases, as needed via Indefinite Delivery/Indefinite Quantity (IDIQ) 
contracts and SNS maintains IDIQ contracts for emergency purchases, 
such as pandemic preparation and response. It is my understanding that 
the Biomedical Advanced Research and Development Authority (BARDA) is 
not currently buying any syringes and has not received any funds to 
procure syringes at this time.

    In light of the COVID-19 outbreak and the concerns from CDC of a 
possible spread, do you believe it is necessary for the SNS to begin 
purchasing necessary supplies like syringes?

    Answer. Operation Warp Speed is taking a holistic view of vaccine 
administration supplies (vaccine, vials, syringes, etc.) to ensure we 
have ample quantities to meet demand. We are working closely with 
needle and syringe manufacturers to ensure sufficient supply remains 
available throughout the duration of the vaccine administration 
campaign.

    Specifically, BARDA, in coordination with the SNS, FEMA, and DoD, 
has initiated procurement contracts with ancillary manufacturers to 
acquire stockpiles of ancillary supplies such as needle and syringes. 
BARDA is supporting ASPR/SNS efforts to place additional ancillary 
manufacturers under contract to bolster the manufacturing base. 
Finally, BARDA is working with FEMA and the DoD using DPA Title III to 
incentivize ancillary manufacturing capacity increases at multiple 
locations as well as recently awarded projects funding vial 
manufacturing in two locations. BARDA and its partners will continue to 
identify worthy projects as we acquire more information about the state 
of manufacturing in the health care sector. BARDA is currently 
collecting information on production capacity, including the 
availability of materials needed for fill/finish (e.g., vials) and 
administration (e.g., needles, syringes). BARDA assesses the need for 
COVID-19-related ancillary supplies above what is needed to administer 
other life-saving medications, with the intention that the 
administration of a COVID-19 MCM will not burden the regular demand of 
other critical domestic health-care needs.

    Question. Given the uncertainty in supply chain, should the SNS 
diversify their sources of these necessary products?

    Answer. Please see answer above.

    Question. In existing IDIQ contracts SNS has set minimum purchasing 
amounts with suppliers. Does SNS take into account the production 
capability of manufacturers in setting these minimum purchase amounts?

    Answer. Please see the response above. BARDA is leading these 
efforts, in coordination with DoD and other Federal partners.

    Question. What appropriations account (identified by Treasury 
Account Symbol) are the IDIQ contracts funded out of?

    Answer. Please see the response above. BARDA is leading these 
efforts, in coordination with DoD and other Federal partners.

                                 ______
                                 
                 Questions Submitted by Hon. John Thune
    Question. As you know, quality and access issues continue at Indian 
Health Service (IHS) facilities in South Dakota. The President's budget 
request includes $12 million for recruitment and retention strategies 
and also references legislative proposals to help build and support a 
competent and caring IHS workforce. What are the legislative proposals 
the administration is seeking?

    Answer. The administration is seeking the following legislative 
proposals:

        To provide the Indian Health Service discretionary use of all 
title 38 personnel authorities.
        To provide half-time basis service obligation option for the 
Indian Health Service scholarship and loan repayment program.
        To seek an income tax exclusion for the Indian Health Service 
scholarship and loan repayment programs.
        To seek a waiver of Indian preference when there is an urgent 
staffing issue and specific conditions are met.
        To seek a withholding annuity and retiree pay for retired 
civil service employees convicted of moral turpitude.

    IHS Congressional Justifications can be viewed and downloaded here: 
https://www.ihs.gov/budgetformulation/congressionaljustifications/.

    Question. Former IHS pediatrician, Stanley Weber, has been 
convicted and sentenced for multiple sexual abuse charges. I understand 
the Department awarded a contract last year to an outside company to 
investigate whether IHS protocol had been followed in handling these 
allegations, so I'd like to inquire if that investigation has concluded 
and what information will be shared with Congress?

    Answer. On May 10, 2019, IHS awarded a contract to an external 
contractor to conduct a medical quality assurance (MQA) review to 
examine whether laws, policies, and procedures have been followed with 
regard to protecting patients from sexual abuse. The report included a 
retrospective MQA review to evaluate actions taken from 1986 (when 
former IHS pediatrician Stanley Weber began working at IHS) to the 
present. The report by the external contractor was submitted to IHS in 
January 2020. Congress established specific restrictions regarding 
confidentiality and privilege of MQA records, pursuant to 25 U.S.C. 
1675(e)(2). IHS made the redacted report available to certain 
congressional staff, including representatives from the South Dakota 
congressional delegation, at HHS headquarters on February 28, 2020 and 
March 2, 2020. The Government Accountability Office (GAO) received a 
redacted copy from IHS on March 16, 2020. The information that was 
redacted was in accordance with provisions of the Privacy Act, the 
Indian Healthcare Improvement Act, the Health Insurance Portability and 
Accountability Act, and applicable law regarding attorney-client 
privilege.

    Question. In your response for the record last year, you stated 
that IHS implemented a new credentialing and privileging system for new 
applicants and re-applicants at IHS, and that privileging and 
performance evaluations would eventually also be tracked there. Have 
the performance evaluations been fully integrated into the new system? 
How does the system work to identify issues with existing providers, 
and not just providers in the application process?

    Answer. In response to your first question, the IHS centralized 
credentialing and privileging software (ASM/MD-Staff) is being utilized 
in all facilities. The credentialing system implementation began in the 
IHS Phoenix Area in May 2017. The system automates aspects of the 
credentialing process, including the completion of initial and regular 
monthly verification of provider credentials, flagging any negatively 
changed items. This is an improved process that now provides real time 
situational awareness to governing boards on provider's status. In 
addition, while the system does provide a good resource for provider 
performance evaluation information, these evaluations are not created 
solely by, or stored within, the ASM/MD-Staff system.

    In response to your second question, performance management and 
evaluations are completed in accordance with IHS and Department 
policies and procedures. Performance management requirements are 
coordinated by human resources (HR) and evaluations are stored within 
the HR systems. IHS is working with the Department to establish an HHS 
enterprise-wide electronic performance evaluation system to manage and 
track provider performance throughout the year. IHS Medical staff peer 
evaluation (OPPE/FPPE) requirements are guided by CMS and accreditation 
organizations, and these records are maintained in accordance with CMS 
regulations and accreditation standards within the Medical Staff files 
at each facility.

    Question. Another former IHS provider, Pedro Ibarra-Perocier, was 
recently indicted on charges of sexual abuse. I understand he was 
placed on administrative leave while IHS investigated, but had been 
allowed to work at the local area office. It has also been reported 
that he had previously been accused of workplace harassment by other 
employees. These repeat problems with staff are unacceptable. As head 
of the Department that oversees IHS, what more can you do to drive 
major change there?

    Answer. As the administration continues to prioritize the health 
and well-being of American Indians and Alaska Natives, I am pleased to 
report that the IHS has made important strides to address and prevent 
sexual abuse in health-care facilities and strengthen policies on 
patient protections and staff reporting. Patients and employees should 
never face sexual harassment or abuse, and that includes our IHS 
providers. IHS continues to institute necessary reforms to create the 
high quality care environment that patients and employees should expect 
in IHS clinics and hospitals.

    IHS issued new policies that address the types of protections set 
forth by nationally recognized professional organizations and has made 
significant progress on implementation. IHS is committed to protecting 
patients from sexual abuse and is determined to hold anyone accountable 
who has abused patients or failed to protect them. IHS requires annual 
mandatory training to strengthen protections against the sexual abuse 
and exploitation of children. The training reinforces IHS policy and is 
designed to help employees identify and immediately respond to 
suspected child maltreatment. IHS has also implemented a centralized 
credentialing system,\1\ allowing credentialing staff now to access 
provider credentialing information in a single electronic database for 
all Federal IHS facilities. In addition, IHS recently announced the 
expansion of specialty care services, including behavioral health 
through telemedicine \2\ as recommended by the White House Task Force 
to Protect Native American Children in the Indian Health Service 
System.\3\ Several of the recommendations in the Task Force's report 
would require congressional action. As indicated in response to your 
first question, the IHS has already made legislative proposals in the 
agency's Fiscal Year 2021 Congressional Justification of Estimates for 
Appropriations Committees \4\ that would address several 
recommendations. The link to the congressional justifications can be 
found here: https://www.ihs.gov/budgetformulation/
congressionaljustifications/.
---------------------------------------------------------------------------
    \1\ https://www.ihs.gov/budgetformulation/
congressionaljustifications/.
    \2\ https://www.ihs.gov/newsroom/pressreleases/2020-press-releases/
indian-health-service-announces-expansion-of-specialty-care-in-
billings-area/.
    \3\ https://www.whitehouse.gov/wp-content/uploads/2020/07/Task-
Force-Report-Protecting-Native-American-Children-in-the-Indian-Health-
Service-System-April-2020.pdf.
    \4\ https://www.ihs.gov/sites/budgetformulation/themes/
responsive2017/display--objects/documents/FY_2021_Final_CJ-IHS.pdf.

    Question. As you know, I've been interested in the IHS electronic 
health record modernization since VA announced it would be 
transitioning its system in 2017. I appreciate that you provided a 2019 
timeline in responses to questions for the record last year, and thanks 
for the specific mention of this issue in the 2021 budget. While the 
budget provides a roadmap for additional steps to be taken, I'd like to 
know if there is a targeted end date for completion of this 
---------------------------------------------------------------------------
modernization project?

    Answer. The Health IT Modernization project will take 7-10 years to 
complete, including a nationwide rollout to over 400 sites. Please see 
the following timeline below.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Question. In 2018, CMS issued a much anticipated interim final rule 
that offered relief to durable medical equipment providers in some of 
the most rural areas, and CMS further extended that policy through 
subsequent regulation. This relief is scheduled to conclude at the end 
of 2020. Do you anticipate that CMS will further extend or expand this 
relief to ensure beneficiaries do not experience a disruption in access 
to needed equipment? Will you commit to continuing to work with my 
office on this?

    Answer. In November 2018, CMS published a final rule finalizing a 
fee schedule adjustment methodology for the Durable Medical Equipment, 
Prosthetics, Orthotics, and Supplies (DMEPOS) items and services 
furnished from January 1, 2019 through December 31, 2020 in areas that 
are not Competitive Bidding Areas and are either rural areas or non-
contiguous areas.\5\ In accordance with section 3712(a) of the 
Coronavirus Aid, Relief, and Economic Security (CARES) Act, CMS will 
continue to adjust the fee schedule amounts for items and services 
furnished in rural and non-contiguous non-competitive bidding areas 
within the U.S. based on a 50/50 blend of adjusted and unadjusted rates 
for the remainder of 2020 and through the remainder of the public 
health emergency, which could mean that this fee schedule adjustment 
methodology continues into 2021 if the public health emergency is still 
in effect after December 31, 2020. Also, as required by section 3712(b) 
of the CARES Act, CMS will provide higher payments for certain DMEPOS 
items and services furnished in non-rural, non-competitive bidding 
areas within the contiguous U.S. with dates of service on or after 
March 6, 2020, through the remainder of the public health emergency.
---------------------------------------------------------------------------
    \5\ Final rule available at: https://www.federalregister.gov/
documents/2018/11/14/2018-24238/medicare-program-end-stage-renal-
disease-prospective-payment-system-payment-for-renal-dialysis.

    We are available to work with your office to provide technical 
---------------------------------------------------------------------------
assistance on draft legislation.

    Question. Last year, several Finance Committee members sent a 
letter to the Department urging you to take administrative action to 
address the issue of retroactive DIR fees that pharmacists in all of 
our States find extremely challenging. Can you provide any insight as 
to what the Department's plans are in this area?

    Answer. The administration is committed to putting American 
patients first by addressing the rising cost of prescription drugs for 
the American consumer. We value the critical role pharmacies play in 
health-care delivery and recognize that we cannot serve our 
beneficiaries effectively without addressing the needs of pharmacies. 
We appreciate the feedback of the committee as we evaluate ways to 
address the high cost of prescription drugs.

    Question. As a proponent of value-based insurance design, I am 
hoping you would elaborate further on the demonstration referenced in 
the budget that aims to reduce the utilization of low-value care in 
Medicare. How do you plan to go about testing these options and what 
sort of options are you considering?

    Answer. Under this budget proposal, CMS will explore options within 
their current demonstration authority to test prior authorization of 
low-value services. The demonstrations or models may include, but are 
not limited to, testing prior authorization on spinal injections for 
low back pain, carotid artery disease screening in asymptomatic adults, 
and vertebroplasty. When implementing this proposal CMS will consider 
patient access and other quality concerns, in an effort to reduce 
burden on patients while ensuring appropriate provision of health care.

                                 ______
                                 
                 Questions Submitted by Hon. Tim Scott
                   on antimicrobial resistance (amr)
    Question. One of the most significant health and security threats 
facing Americans today is the rise of antimicrobial resistance, or 
``AMR.'' We have an urgent need for new antibiotics to combat growing 
resistance, but there has been a significant decline in the number of 
companies investing in antibiotic R&D. With more than 10 million deaths 
projected each year beginning in 2050, AMR requires action now. In 
South Carolina, when I speak with providers, patient advocates, public 
health groups, academics, innovative manufacturers, and those invested 
in our national defense, all agree that the present and future 
challenges posed by AMR demand proactive, nonpartisan public policy 
solutions.

    The fact is, investment in novel antibiotics has lagged, the 
pipeline is slim, and the threat is growing exponentially. We cannot 
afford to be reactive.

    What steps has the Federal Government taken, and what further steps 
is it considering taking, to encourage more industry investment on this 
front and to stabilize long-term development in novel antibiotics?

    Answer. HHS supports the implementation of the U.S. National Action 
Plan for Combating Antibiotic-Resistant Bacteria (CARB), which is a 
multifaceted strategy to improve how the United States addresses the 
threat of antibiotic resistance (AR) including the development of new 
antibiotics.

    CDC's AR Solutions Initiative invests in national infrastructure to 
detect, respond, contain, and prevent resistant infections across 
health-care settings, food, and communities. Data from CDC's AR 
surveillance systems and laboratory infrastructure is critical to 
highlighting national and international challenges related to 
resistance and informing areas of greatest need for research and 
development. Additionally, the CDC and FDA AR Isolate Bank supports 
therapeutic, vaccine and diagnostic development by sharing curated AR 
isolates with the private sector and academic researchers and makes 
CDC's sequencing data from AR pathogens publicly available to spur 
industry innovation. CDC will continue to encourage investment in 
antibiotic innovation through the next iteration of the U.S. National 
Action Plan for Combating Antibiotic-Resistant Bacteria (CARB 2.0) by 
working with partners across all sectors to further strengthen the 
collection of AR data, provide isolates, evaluate new agents, and 
update guidelines.

    Question. Do we have a sense, at this point, of how many Americans 
with coronavirus infections or seasonal influenza will contract a 
serious secondary infection from drug-resistant bacteria? Do we have 
the antibiotics needed to solve this problem?

    Answer. Preliminary CDC data show that bacterial and fungal 
infections in COVID-19 patients from 2020 do not appear to be more 
common than infections in patients with influenza-like illness (ILI) 
from 2019. The currently available data indicate that bacterial and 
fungal infections occur at about the same frequency overall in patients 
with COVID-19 as they do in patients with ILI. However, when analyzed 
by where the infection occurs based on onset, the data indicate that 
hospital-onset, secondary bacterial and fungal infections occur more 
frequently in COVID patients than ILI, emphasizing the importance of 
health-care infection control practices, while community onset 
infections occur less frequently. COVID-19 creates a perfect storm for 
AR infections in health-care settings with multiple issues likely 
driving their increased frequency: longer length of stay, crowding, 
severely ill patients, common antibiotic use, and infection control 
challenges like shortages of PPE.

    CDC is actively evaluating data related to bacterial and fungal 
infections in COVID patients and will be assessing if and how the type 
of patients impacted differs significantly from previous trends. Data 
from these analyses came during a period of decreased hospital 
utilization for non-COVID patient care and could shift with a return to 
elective procedures and other patient care. CDC is also working with 
States to respond to outbreaks of drug resistant infections in COVID 
units that appear to be related to lapses in infection control 
practices. To date, CDC and its AR Lab Network have identified at least 
10 outbreaks in COVID units around the country and is reaching out to 
health departments and health-care facilities to identify others. The 
pathogens identified in the outbreaks include pathogens listed as 
Urgent Threats in CDC's 2019 AR Threats Report, including multi-drug 
resistant Enterobacteriaceae such as Carbapenem-resistant 
Enterobacteriaceae, Candida auris, and multi-drug resistant 
Acinetobacter such as Carbapenem-resistant Acinetobacter (CRAB).

    CDC recently presented data on antibiotic use and secondary 
bacterial infections related to COVID-19 at the virtual meeting of the 
Presidential Advisory Council on Combating Antibiotic-Resistant 
Bacteria (PACCARB), on September 9 and 10, 2020. This Council meeting 
also included multiple other presentations from Federal, industry, and 
academic partners on the intersection between COVID-19 and antibiotic 
resistance. Presentations from this meeting are archived on the PACCARB 
website (https://www.hhs.gov/ash/advisory-committees/paccarb/meetings/
index.html).

    Question. An emerging consensus among diverse stakeholders points 
towards a robust pull incentive as a means of incentivizing the 
investment and innovative research and development necessary to ensure 
a sustainable pipeline of products that can adequately address both the 
short- and longer-term effects of AMR?

    Answer. HHS convened a workgroup in March 2019 to analyze existing 
incentives, potential proposals for new incentives as raised by non-
governmental, industry, and international groups, and other options to 
develop a strategic framework to further incentivize the development of 
new treatments for antibiotic-resistant infections. This analysis has 
included consideration of the current and future burden of AMR on both 
public health and the economy, as well as the dynamics of drug 
development that specifically impact relevant antibacterial and related 
products. This work is ongoing.
          on value-based arrangements for innovative therapies
    Question. We have discussed at length some of the various 
challenges facing innovative therapies, even after they receive FDA 
approval. Gene therapies, cell-based therapies, and a host of other 
diverse treatment options hold tremendous promise for patients, but 
traditional payment models lack the tools and flexibilities needed to 
ensure sustainable access to these novel products, injecting 
uncertainty into long-term investment forecasts and inhibiting 
patients' ability to benefit from them.

    In the case of sickle cell disease, for instance, despite nearly 20 
novel therapies on the horizon, which could save millions in the long 
term and enhance quality of life for many of the estimated 100,000 
American patients currently suffering from the condition, conventional 
payment structures would likely be a poor fit, whereas innovative 
frameworks that allow for payment over time, conditioned on the 
attainment of key clinical endpoints, would better reward value while 
sustainably absorbing costs.

    Unfortunately, outdated statutory and regulatory provisions create 
disincentives and barriers for these types of value-based arrangements, 
particularly with regards to price reporting and the Anti-Kickback 
Statute.

    Secretary Azar, in what ways might current price reporting rules, 
such as for Medicaid AMP and Best Price, create obstacles for robust 
value-based arrangements, both commercially and in our public health 
programs?

    I was encouraged by your Department's decision to move forward with 
new safe harbor protections for certain value-based contracts under the 
OIG rulemaking regarding AKS and Stark, but, as the rule explicitly 
explains, novel therapeutics and devices were excluded. What plans does 
your agency have for providing the regulatory protections necessary for 
robust VBAs for innovative therapies and other products not included in 
the recent rulemaking?

    Answer. Gene therapies are innovative new treatments that repair 
defects in a patient's genetic code. While the life-saving impact of 
these often curative therapies are profound, their costs are 
unprecedented. To ensure access to gene therapies and other 
groundbreaking medicines--the list price for which can approach or 
exceed a million dollars for one course of therapy--it is critical to 
shift the Nation's payment systems to reward value.

    Value-based payment in health care involves basing payment on 
improvements in patient outcomes. Hospital reimbursement and clinician 
reimbursement are moving from systems of payment based on the volume of 
care provided to payment based on value or outcomes. However, value-
based payment for prescription drugs is still in its infancy. Current 
CMS regulations do not readily accommodate value-based payment 
arrangements. For example, when reporting Medicaid Best Price, which is 
the lowest net price a manufacturer offers in the U.S. after factoring 
in all rebates and discounts, manufacturers face challenges accounting 
for rebates and discounts offered for these value-based payment 
arrangements under current regulations, which may inhibit wider use of 
such agreements.

    In June, as part of President Trump's longstanding commitment to 
lowering drug prices, HHS issued a proposed rule that would start to 
remove barriers to the development of payment models based on value for 
innovative new therapies. The proposed rule includes provisions that 
would support the health-care system's move to paying on the basis of 
value instead of volume and increasing accountability for outcomes, as 
payers (commercial and government) would be able to better negotiate 
discounts based on a drug's effectiveness. For example, the specific 
proposals in CMS's proposed rule would provide payers and manufacturers 
the flexibility to consider new value-based purchasing options while 
ensuring that Medicaid always gets the best deal, and would ensure that 
Best Price accurately captures both the prices that are paid in new 
types of payment models and the circumstances in which those prices are 
paid. In addition, more widespread adoption of payment arrangements 
based on value could lead to the collection of more evidence on 
clinical outcomes for a given therapy. This type of real-world, real-
time evidence could help providers use new medications and treatments 
in a more targeted fashion. Increasing the link between reimbursement 
and drug effectiveness will also encourage payers to facilitate 
patients' access to new therapies by easing more traditional 
utilization management practices.

    By offering more flexibility for payers and manufacturers to enter 
into value-based agreements while still ensuring that Medicaid always 
gets the best deal, HHS is continuing its efforts to foster innovation, 
increase access to the latest technologies, and ensure that the 
Medicaid program is sustainable and can continue to serve our most 
vulnerable populations.

    As part of the Department's Regulatory Sprint to Coordinated Care, 
which aims to reduce regulatory barriers imposed on health care 
industry stakeholders to advance the transition to value-based care and 
promote care coordination, both CMS and the Office of Inspector General 
(OIG) published proposed rules in October 2019 that would create new 
flexibilities for value-based arrangements under the physician self-
referral law and Federal anti-kickback statute, respectively, to 
account for the ongoing evolution of the health care delivery system, 
and in the case of the CMS rule, modernize the interpretation of the 
physician self-referral law.

    On November 20, 2020, CMS announced the final rule, ``Medicare 
Program; Modernizing and Clarifying the Physician Self-Referral 
Regulations,'' which was published in the Federal Register on December 
2nd (https://www.federalregister.gov/documents/2020/12/02/2020-26140/
medicare-program-modernizing-and-clarifying-the-physician-self-
referral-regulations). The final rule includes a comprehensive package 
of reforms to modernize the regulations that interpret the Stark Law 
while continuing to protect the Medicare program and patients from bad 
actors. This includes finalizing policies that advance the transition 
to a value-based health-care delivery and payment system that improves 
the coordination of care among physicians and other health-care 
providers in both the Federal and commercial sectors.

    In OIG's notice of proposed rulemaking, OIG indicated that value-
based contracting and outcomes-based contracting arrangements for 
pharmaceutical products raise unique program integrity issues from the 
arrangements that are addressed in the proposed rule. As a result, OIG 
has considered and continues to consider the development of future 
rulemaking to provide specifically tailored safe harbor protection for 
value-based contracting and outcomes-based contracting for the purchase 
of pharmaceutical products (and potentially other types of products).
                      on virtual providers in mdpp
    Question. Since coming to Congress, combating diabetes has been one 
of my top priorities. More than 576,000 South Carolinians have 
diabetes, comprising 14.1 percent of our adult population, and more 
than 1.3 million people across the State have prediabetes. We 
unfortunately have the eighth highest diabetes rate in the country.

    From a quality of life perspective and a cost perspective, diabetes 
is devastating. People who have it face medical expenses roughly 2.3 
times higher than folks who do not. I applaud your agency for moving 
forward with the Medicare Diabetes Prevention Program model, which 
strikes me as a meaningful and cost-effective way to empower Americans 
to take the steps necessary to reduce their own risk of diabetes, along 
with some of the other conditions that too often come along with it.

    That said, I know the uptake for MDPP has been lower than expected, 
which is why I partnered with Senator Warner and a bipartisan group of 
our colleagues to send a letter to CMMI requesting that CDC-recognized 
virtual providers be included. This would present an ideal avenue for 
expanding access through high-
quality, innovative programming.

    What role do you see virtual providers--and innovative technology 
more broadly--playing as we work to more effectively prevent and combat 
diabetes?

    Would you be willing to consider implementing an MDPP model that 
integrates and assesses the work of virtual health technology?

    In your department's budget request, there was a reference to 
``Innovative Alternatives to Durable Medical Equipment for Treatment 
and Management of Diabetes.'' Could you elaborate on how this might 
look in practice and what efforts your agency might be undertaking 
along these lines? To what extent might this area involve virtual 
health technology?

    Answer. During the COVID-19 Public Health Emergency (PHE), the 
Department, through an Interim Final Rule with comment (IFC), amended 
the Medicare Diabetes Prevention Program (MDPP) expanded model to 
modify certain MDPP policies during the PHE. Specifically, this IFC 
will permit certain beneficiaries to obtain the set of MDPP services 
more than once per lifetime, increase the number of virtual make-up 
sessions, and allow certain MDPP suppliers to deliver virtual MDPP 
sessions on a temporary basis. Our goal is to align MDPP model-specific 
changes as much as possible to what the Centers for Disease Control and 
Prevention (CDC) has released for the duration of the PHE.

    Regarding the budget request you mentioned, allowing coverage of 
non-durable medical equipment would provide beneficiaries innovative 
options for their health care not currently available in the Medicare 
benefit for DME. These alternatives may not meet the lifetime or 
repeatable use standard, but could improve beneficiary lifestyle and 
health outcomes, while not increasing costs to Medicare. Non-durable 
medical equipment may be more compact and not tethered to electrical 
cords, which increases patient mobility, and thus, may improve patient 
compliance with device use. Further, the non-durable medical equipment 
items may be safer for some beneficiaries than the covered DME item, 
for example: lower risk of infection due to disposable nature; non-
electrical so avoids electrical malfunction; and uses of safe 
alternative materials to avoid beneficiary allergic reaction.

    Additionally, it is possible that such features could improve 
patient compliance and clinical outcomes. Also, the benefit could allow 
potential coverage of additional treatment options for the patient that 
may offer a therapeutic advantage over durable alternatives (e.g., 
reduced treatment times).
                                on mfar
    Question. In South Carolina, we have a supplemental payment program 
that is used to help offset the cost of providing medical education at 
our teaching hospitals. Our State Medicaid agency projected that the 
MFAR rule would cut those payments by about 60 percent, with the cuts 
targeting hospitals that serve children and those with complex needs.

    For the past several years, CMS has talked about aligning Medicaid 
with the commercial market. Why is CMS now proposing to replace average 
commercial rates as the limit for Medicaid supplemental payments with 
arbitrary new limits that are tied to Medicaid base payments?

    South Carolina spends less money for each Medicaid beneficiary than 
nearly any other State in the country. I've seen reports showing that 
some other States spend nearly three times as much per-member as we do. 
I am concerned that MFAR disproportionately impacts SC, one of our most 
efficient States, by targeting its children's and teaching hospitals.

    I am also concerned about the procedural aspects of MFAR. In South 
Carolina, we have had Medicaid State plan amendments that were pending 
for 6 years before CMS approved them. MFAR would require that CMS 
immediately re-approve all supplemental payment programs and then 
approve them again every 3 years thereafter, whether States proposed to 
amend them or not. I support CMS's focus on cutting red tape, but all 
of these re-approvals would inevitably mean more paperwork.

    In light of ongoing backlogs and other labor-intensive approval 
processes, why would CMS add another expansive re-approval process into 
the mix, creating additional paperwork, particularly in the case of 
States not even making changes?

    Answer. The Medicaid Fiscal Accountability Regulation (MFAR), CMS-
2393-P, was published in the November 18, 2019, issue of the Federal 
Register, with a 60-day comment period that closed on January 17, 2020, 
which was subsequently extended by 15 days and closed on February 1, 
2020. During this time, CMS also conducted numerous calls with States 
and other stakeholders to receive substantive feedback to help us 
understand the potential impact of the proposed rule.

    The policies proposed within the rule are intended to ensure 
accountability of State financing, transparency of payments, and the 
fiscal integrity of the Medicaid program, including through numerous 
clarifications to Medicaid financing and oversight rules. Specifically, 
this proposed rule would impact States' reporting on payment methods 
and procedures to assure consistency with efficiency, economy, and 
quality of care as required by section 1902(a)(30)(A) of the Act. CMS, 
and other Federal oversight entities, have found that current 
regulations and guidance do not adequately ensure that States are 
complying with the efficiency, economy and quality of care requirements 
of section 1902(a)(30)(A) of the Act, and this proposed rule is 
intended to address those deficiencies. Please know that we have 
listened closely to concerns that have been raised by our State and 
provider partners about potential unintended consequences of the 
proposed rule, which require further study. Therefore, CMS has 
withdrawn the rule from the regulatory agenda.
                       on opioid co-prescription
    Question. On April 5, 2018, the Surgeon General released an 
advisory statement, emphasizing the importance of expanding access to 
naloxone. In December 2018, an FDA joint advisory panel recommended the 
co-prescribing of naloxone with opioids. Shortly thereafter, HHS 
released naloxone co-prescription guidelines, calling for ``co-
prescribing naloxone when a patient is considered to be at high risk of 
an overdose,'' as ``an essential element of our national effort to 
reduce overdose deaths'' that ``should be practiced widely.''

    In April 2019, CMS released the final 2020 Medicare Advantage and 
Part D Advance Notice Part II and Draft Call Letter, encouraging 
insurance plans to implement co-prescribing for beneficiaries at an 
increased risk for an opioid overdose. South Carolina is actively 
considering legislation in its House of Representatives to join 9 other 
States in implementing naloxone co-prescription policies. In short, the 
Surgeon General, HHS, CDC, CMS, SAMSHA, the AMA, AAFP, ASAM, a growing 
number of States including hopefully South Carolina, and FDA's advisory 
committee all support increasing access to naloxone through co-
prescription.

    Our current understanding is that, to date, no FDA action has been 
taken in response to the recommendation of its joint advisory committee 
or the growing consensus outlined above. Could you please provide an 
update on FDA consideration of recommending co-prescribing of naloxone 
with opioids for populations at elevated risk of opioid overdose?

    Answer. On July 23, 2020, FDA announced it is requiring that 
labeling for opioid pain medicine and medicine to treat opioid use 
disorder (OUD) be updated to recommend that as a routine part of 
prescribing these medicines, health care professionals should discuss 
the availability of naloxone with patients and caregivers, both when 
beginning and renewing treatment.

    The required labeling changes, announced in a Drug Safety 
Communication, also recommend that health-care professionals consider 
prescribing naloxone when they prescribe medicines to treat OUD. 
Additionally, the labeling changes recommend that health care 
professionals consider prescribing naloxone to patients being 
prescribed opioid pain medicines who are at increased risk of opioid 
overdose, including those who are also taking benzodiazepines or other 
medicines that depress the central nervous system; those who have a 
history of OUD; and those who have experienced a prior opioid overdose. 
A naloxone prescription should also be considered for patients 
prescribed opioids who have household members, including children, or 
other close contacts at risk for accidental ingestion or opioid 
overdose.

    The FDA is requiring that these recommendations be added to the 
prescribing information for opioid pain medicines and medicines to 
treat OUD, including buprenorphine, methadone, and naltrexone and for 
patients who may be at high risk of an opioid overdose like those with 
a prescription for sedatives like benzodiazepines.

    The FDA is working with other Federal, State, and local officials 
as well as health-care professionals, patients, and communities 
nationwide to help increase availability of naloxone and combat opioid 
overdoses. Patients should talk to their health-care professional about 
how to obtain naloxone according to their State's requirements or 
guidelines. The U.S. Department of Health and Human Services has 
ongoing efforts to fight the opioid crisis and expand the use of 
naloxone. This includes: better targeting of overdose reversing drugs 
as part of a 5-Point Strategy to Combat the Opioids Crisis.

    Planning is also underway within CDER's Office of Communications to 
promote additional naloxone communication and outreach among health-
care providers, including a webinar that may be eligible for a 
continuing education credit.

                                 ______
                                 
                Questions Submitted by Hon. Bill Cassidy
                     cmmi direct contracting model
    Question. My office has heard some concerns from providers in 
Louisiana that under the current structure of the Direct Contracting 
option, physicians will not be successful in the model. The benchmark 
calculation methodology penalizes providers who have been participating 
in coordinated care of their population, such as the Medicare Shared 
Savings Program or Next Generation ACO, by basing the payment amount on 
the cost of care over the previous 3 years, but weighted at 50 percent 
for the last year. The benchmark will be lower compared to newly 
entered entities with no previous care coordination of their 
population, thus skewing benchmarks to a higher value, giving them the 
chance to capture greater shared savings. If the Direct Contracting 
Model is going to be successful, CMS needs to attract both high 
performing groups and new entrants interested in taking on risk.

    What are some ways that CMS could take this into account to ensure 
the model offers opportunities for success for all varieties of 
physicians?

    Answer. Direct Contracting is a set of two voluntary participation 
options aimed at reducing expenditures and preserving or enhancing 
quality of care for beneficiaries in Medicare fee-for-service (FFS). 
The participation options available under Direct Contracting create 
opportunities for a broad range of organizations to participate with 
the Centers for Medicare and Medicaid Services (CMS) in testing the 
next evolution of risk-sharing arrangements to produce value and high 
quality health care. Building on lessons learned from initiatives 
involving Medicare Accountable Care Organizations (ACOs), such as the 
Medicare Shared Savings Program and the Next Generation ACO Model, the 
participation options available under Direct Contracting also leverage 
innovative approaches from Medicare Advantage (MA) and private sector 
risk-sharing arrangements.

    The participation options are anticipated to appeal to a broad 
range of physician practices and other organizations because they are 
expected to reduce burden, support a focus on beneficiaries with 
complex, chronic conditions, and encourage participation from 
organizations that have not typically participated in Medicare FFS or 
CMS Innovation Center models.

    A key aspect of Direct Contracting is providing new opportunities 
for a variety of different organizations (Direct Contracting Entities 
or DCEs) to participate in value-based care arrangements in Medicare 
FFS. Under Direct Contracting, there will be three types of DCEs with 
different characteristics and operational parameters. These three types 
of DCEs are:

        Standard DCEs--DCEs comprised of organizations that generally 
have experience serving Medicare FFS beneficiaries, including Medicare-
only and also dually eligible beneficiaries, who are aligned to a DCE 
through voluntary alignment or claims-based alignment. These 
organizations may have previously participated in section 1115A shared 
savings models (e.g., Next Generation ACO Model and Pioneer ACO Model) 
and/or the Shared Savings Program. Alternatively, new organizations, 
composed of existing Medicare FFS providers and suppliers, may be 
created in order to participate in this DCE type. In either case, CMS 
expects that clinicians participating within these organizations would 
have substantial experience serving Medicare FFS beneficiaries.
        New Entrant DCEs--DCEs comprised of organizations that have 
not traditionally provided services to a Medicare FFS population and 
who will primarily rely on voluntary alignment, at least in the first 
few performance years of the model. Claims-based alignment will also be 
utilized.
        High Needs Population DCEs--DCEs that serve Medicare FFS 
beneficiaries with complex needs, including dually eligible 
beneficiaries, who are aligned to the DCE through voluntary alignment 
or claims-based alignment. These DCEs are expected to use a model of 
care designed to serve individuals with complex needs, such as the one 
employed by the Programs of All-Inclusive Care for the Elderly (PACE), 
to coordinate care for their aligned beneficiaries.

    CMS recently issued the financial methodology and rate books for 
the Direct Contracting model, and has held numerous webinars and office 
hours for interested stakeholders. More information can be found on the 
Direct Contracting website at: https://innovation.cms.gov/innovation-
models/direct-contracting-model-options.
                              next gen aco
    Question. There are also concerns by primary care providers about 
the deductions and withholds built into this model. A 2-percent 
retention withhold to protect against early withdrawal seems excessive 
when applied to an experienced ACO that has a proven track records in 
value-based care.

    Can CMS forgo the 2-percent retention withhold for those Next Gen 
ACO's that have proven experience in shared risk contracting with 
Medicare?

    I have heard concerns from providers in my State regarding the 
continuation of the CMS Next Generation ACO Model. There have been 
reports that CMS may discontinue the model and require participants to 
transition to other risk-based models. Cumulatively over 2016-2017, 
Next Gen ACOs saved Medicare $123 million, however no savings once 
factoring in shared savings. However, changing policy with an intended 
budget neutral effect can have tremendous impacts on behavioral 
economics, and save the system money. The NGACO Model seems to be 
successfully aligning incentives around the patient, and changing the 
way doctors and systems care for Medicare beneficiaries. It may be 
shortsighted to discontinue the model just because it showed modest 
savings.

    Is CMS planning on making changes to the NextGen ACO Model, and if 
so, why?

    Answer. In response to the COVID-19 Public Health Emergency (PHE), 
CMS made adjustments to some Innovation Center models. This included 
extending the Next Generation ACO Model through December 2021. In 
addition to this extension, CMS reduced participants' downside risk by 
proportionally reducing shared losses based on the number of months 
that fall within the PHE and also removed certain episodes of care for 
the treatment of COVID-19 from the calculation of shared savings or 
shared losses.
                   aca and magi eligibility standard
    Question. The ACA greatly exacerbated improper payments and 
eligibility issues--the Modified Adjusted Gross Income (MAGI) 
eligibility rules prohibit States from conducting asset verification 
tests for the expansion population. Asset verification meanwhile is 
required for the traditional aged, blind, and disabled population. This 
creates an incentive to enroll able-bodied adults over truly needy 
populations. The budget provides States the option to apply asset tests 
to populations determined financially eligible by the MAGI standard, so 
States can refocus resources on the truly needy.

    How would allowing States to consider held assets in the MAGI 
determination process ensure the Medicaid program is serving the truly 
needy, and not some folks sitting on a relative fortune?

    Answer. Asset tests allow States to prioritize receipt of Medicaid 
for lower-income individuals by screening for assets and resources, 
such as savings accounts or vehicles. The ACA's Modified Adjusted Gross 
Income (MAGI) eligibility rules eliminated asset tests for most 
children and able-bodied adults, leaving asset tests only for aged, 
blind, and disabled Medicaid beneficiaries. The budget proposes to 
allow States the option to apply asset tests to populations determined 
financially eligible by the MAGI standard, such as able-bodied adults, 
so States can refocus Medicaid on the truly needy. This proposal also 
provides States with the option to apply asset tests to individuals 
eligible through the MAGI standard who are receiving long-term care.

    Greater flexibility to expand asset tests to MAGI populations could 
allow States to refocus Medicaid on the most vulnerable individuals by 
screening out individuals who have financial and other assets due to a 
windfall or savings and may be able to afford to pay for private 
insurance or medical expenses.

                                 ______
                                 
                 Questions Submitted by Hon. Todd Young
                    organ donation--opo competition
    Question. In your testimony, you mention how the administration is 
proposing to increase competition among Organ Procurement Organizations 
(OPOs) to improve performance and increase the supply of organs for 
transplant.

    Can you elaborate on your plans to increase competition?

    How do you plan to do this when these 58 OPOs are regional 
monopolies?
                     organ donation--unos oversight
    I joined Chairman Grassley, Ranking Member Wyden and Senator Cardin 
in a letter to the United Network for Organ Sharing (UNOS) questioning 
the adequacy of their oversight over our 58 OPOs. As the government 
contractor for nearly 40 years, UNOS is responsible for abiding by this 
vision of safety, transparency, and public trust which includes the 
close monitoring of OPOs. But, sadly, under their watch, numerous The 
HHS Office of the Inspector General (OIG) audits and news reports have 
found serious lapses in patient safety, misuse of taxpayer dollars, and 
tens of thousands of organs going unrecovered or not transplanted by 
various OPOs.

    What sort of oversight is HHS providing over UNOS to ensure they're 
living up to the requirements set out in statute?
              organ donation--opo use of taxpayer dollars
    The OIG and others have identified numerous inappropriate uses of 
Medicare funds by OPOs. This includes some OPOs using taxpayer dollars 
to buy sports tickets, charter private planes, and throw lavish 
parties. In one case, an OPO based in southern California used taxpayer 
dollars to throw a lavish New Year's Eve party, buy Rose Bowl tickets, 
and transport their executives in limousines. While OPOs spend taxpayer 
dollars on entertainment, lobbying, and gifts, patients are left 
waiting on a transplant list. This is simply unacceptable.

    How is it that our government contractors are allowing these types 
of expenses to be reimbursed by taxpayers?

    What does HHS plan to do about oversight of these types of 
reimbursements?
                    organ donation--opo performance
    HHS's own data suggests that the vast majority of OPOs are failing, 
and as a result, 1,000 patients die every month for lack of an organ 
transplant. This is simply unacceptable given research cited by the 
President showing that OPOs fail to recover up to 28,000 organs every 
year.

    The Centers for Medicare and Medicaid Services (CMS) has not 
decertified any OPO in decades. I applaud your leadership in changing 
regulations so that OPOs can be held accountable--noting that according 
to proposed rules, the majority of the country's OPOs are failing key 
performance metrics--that includes OPOs in Indiana, Iowa, Oregon, South 
Carolina, Idaho and so many other parts of the country. In the past, 
corrective action plans for OPOs have not worked.

    So what steps are HHS taking now to prepare to actually hold OPOs 
accountable?

    Answer. Several agencies regulate aspects of the U.S. organ 
transplant system. The Department's oversight of organ procurement 
organizations (OPOs) is provided by both the Health Resources and 
Services Administration (HRSA) and by the Centers for Medicare and 
Medicaid Services (CMS). The Organ Procurement and Transplantation 
Network (OPTN) is operated by contract between HRSA and the United 
Network for Organ Sharing (UNOS). Through the OPTN contract, HRSA 
requires the OPTN contractor to monitor and evaluate OPTN member 
compliance and identify potential patient safety threats.

    All OPOs are required to comply with the OPTN final rule (42 CFR 
part 121). OPOs are mandated members of the OPTN and must comply with 
the rules and requirements of the OPTN approved by the Secretary. The 
OPTN maintains bylaws and policies consistent with its authority 
through the National Organ Transplant Act of 1984, the OPTN final rule, 
and the OPTN contract, which includes maintaining a national list of 
individuals who need organs, establishing membership criteria, 
policymaking for allocating organs, and reviewing and evaluating OPTN 
member organizations. The authority of the OPTN does not extend to the 
financial management of OPTN members, but does include oversight of 
member procurement and allocation activities and member compliance. 
Through the OPTN contract, HRSA requires the OPTN contractor to monitor 
and evaluate OPTN member compliance and identify potential patient 
safety threats. Under Federal law, CMS is charged with conducting 
surveys of OPOs to determine whether they meet the Conditions for 
Coverage, including outcome and process measures. Facilities must 
correct any problems cited in surveys in order to be certified and 
continue receiving payment for services from Medicare and Medicaid for 
at least 4 years. If an OPO is decertified, the OPO's donation service 
area (DSA) is opened to competition from other OPOs. CMS then assigns 
one or more other OPOs to serve all or part of the decertified OPO's 
DSA. Existing regulations ensure a DSA is never without an OPO or 
access to organ procurement services, especially donated organs.

    On November 20, 2020, the Department issued a final rule that 
updates the OPO Conditions for Coverage to change the way OPOs are held 
accountable for their performance (https://www.federalregister.gov/
documents/2020/12/02/2020-26329/medicare-and-medicaid-programs-organ-
procurement-organizations-conditions-for-coverage-revisions-to). The 
final rule improves the current measures by using objective and 
reliable data, incentivizes OPOs to ensure all viable organs are 
transplanted, and holds OPOs to greater oversight while driving higher 
OPO performance.

    The rule is a directive of President Trump's executive order on 
Advancing American Kidney Health and would apply to procurement of all 
organs from deceased donors. As a key goal, the President's executive 
order and this final rule seek to help the more than 113,000 people in 
the United States currently on the wait list for a lifesaving organ 
transplant, which far exceeds the number of transplantable organs 
available.

    Under the final rule, all OPOs are encouraged to meet at least the 
donation and transplantation rates of the top 25 percent of OPOs, a 
ranking that will be publicly available. OPOs with performance rates 
that are below the top 25 percent will be required to take action to 
improve their rates through a quality assurance and performance 
improvement (QAPI) program, which CMS will assess at least every 12 
months.

    At the end of each re-certification cycle, each OPO will be 
assigned a tier ranking based on its performance for both the donation 
rate and transplantation rate measures and its performance on the re-
certification survey. The highest performing OPOs that are ranked in 
the top 25 percent will be assigned to Tier 1 and automatically 
recertified for another 4 years. Tier 2 OPOs are the next highest 
performing OPOs, where performance on both measures exceed the median 
but do not reach Tier 1. Tier 2 OPOs will not automatically be 
recertified and will have to compete to retain their donation service 
areas (DSAs). Tier 3 OPOs are the lowest performing OPOs that have one 
or both measures below the median. Tier 3 OPOs will be decertified and 
will not be able to compete for any other open DSA.

    These changes will hold OPOs to greater oversight, transparency, 
and accountability while driving higher OPO performance across the 
board to increase patients' access to needed organ transplants no 
matter where they live.
                     social determinants of health
    Question. A person's health should not be dependent on where they 
live or the economic challenges they face. But, these economic and 
social conditions, such as access to reliable transportation and stable 
housing, do have a profound effect on an individual's health and well-
being. Addressing these factors can have a meaningful impact on the 
prevention and management of chronic diseases in our communities.

    How does the administration plan on addressing these social 
determinants of health?

    Answer. An individual's health is influenced by many factors, 
including socioeconomic factors, physical environment, and their health 
behaviors. Addressing the social determinants of health at play can 
have significant implications on a person's well-being and their 
ability to access comprehensive health care. This has been of paramount 
importance to the administration, and is reflected throughout the 
countless programs aimed at bridging the gap so that Americans can 
access the health care that they need. The administration is actively 
engaged in addressing and promoting health for all; HHS is committed to 
addressing the social determinants of health in all of its programs and 
initiatives and to eliminating barriers to health care.
                             drug shortages
    Question. Drug shortages continue to be a problem for hospitals, 
physicians, and patients--most of whom are left with few alternatives. 
Last October, the Food and Drug Administration (FDA) released its Drug 
Shortage report that included a number of recommendations on how to 
prevent and reduce the impact of drug shortages. I noticed, however, 
that there was nothing specifically outlined in the President's budget 
that addressed this issue.

    Could you outline for us how FDA plans to work with CMS and 
industry to advance the policies outlined in that report?

    Do you believe FDA or CMS require any additional authorities in 
order to implement any of these goals?

    Answer. The U.S. Food and Drug Administration (FDA) continues to 
work to find ways to mitigate drug shortages and does everything within 
our authority to help prevent and alleviate shortages, for both adult 
and pediatric products. We have asked manufacturers to evaluate their 
entire supply chain, including active pharmaceutical ingredients, 
finished dose forms, and any components that may be impacted in any 
area of the supply chain due to the COVID-19 outbreak.

    Our public drug shortages lists are up-to-date with human and 
animal drugs and biological products that we have determined to be in 
shortage. These shortages are not all results of COVID-19, with many 
existing prior to the pandemic as results of market changes and supply 
challenges. We are updating these lists regularly and communicating in 
real-time so that patients and health-care providers have the most 
current information on product shortages in the U.S.

    When potential shortages or disruptions of medical products are 
identified by FDA, we use all available tools to react swiftly to help 
mitigate the impact to U.S. patients and health care professionals. We 
will quickly share that information with the public, as appropriate, in 
close coordination with our Nation's response partners. FDA is working 
closely with manufacturers to make sure that they notify the agency of 
any permanent discontinuance or interruption of drug and biological 
product manufacturing in a timely manner. On March 27, 2020, FDA 
published guidance about the importance of these notifications, the 
timelines that drug and biologic manufacturers should follow when 
notifying the FDA, and the details manufacturers should provide about 
the discontinuance or interruption in manufacturing.

    The FDA issued a report in October, 2019 \6\ entitled, ``Drug 
Shortages: Root Causes and Proposed Solutions.'' The report was the 
work of an inter-agency Drug Shortages Task Force of senior officials 
drawn from FDA's own ranks and several partner Federal agencies, 
including the Centers for Medicare and Medicaid Services (CMS). The 
agency invited public participation through a public meeting on 
November 27, 2018 with a docket to receive comments, and invited 
stakeholders to a series of listening sessions.
---------------------------------------------------------------------------
    \6\ The report was subsequently updated in February 2020.

    The report included three broad recommendations: (1) create a 
shared understanding of the impact of drug shortages and the 
contracting practices that may contribute to them, (2) create a rating 
system to incentivize drug manufacturers to invest in achieving quality 
management system maturity, and (3) promote sustainable private sector 
contracts. The report also proposed several legislative proposals and 
planned FDA initiatives that focus primarily on enabling FDA to help 
prevent supply disruptions from leading to shortages and mitigating 
shortages when they occur. FDA is implementing policies to prevent and 
---------------------------------------------------------------------------
mitigate shortages, including:

        Developing a pilot for a quality management maturity rating 
system.
        Working with international bodies to reduce regulatory 
barriers to making manufacturing changes with a view toward increasing 
production.
        Preparing to implement a requirement added by the CARES Act 
under which drug manufacturers will report annually to FDA on the 
amount of each drug, including finished dosage forms and active 
pharmaceutical ingredients, that they manufacture, prepare, propagate, 
compound, or process for commercial distribution. Under this new 
reporting requirement, that took effect in September 2020, FDA expects 
it will have more insight into the volume of product coming into the 
U.S. market and where supply chains are vulnerable.
        Issuing guidances on information FDA will be collecting as 
part of the ``notification'' process and on risk management plans.
        Supporting advanced manufacturing, which is generally less 
vulnerable to quality problems leading to supply disruptions and 
shortages.

    FDA continues to work with relevant stakeholders (e.g., other 
Federal agencies and drug manufacturers) to facilitate the adoption of 
advanced manufacturing technologies as one of the proactive approaches 
to prevent drug shortages and ensure continuous supply of critical 
drugs in the U.S. Advanced manufacturing technology, which can be more 
cost-effective and environmentally friendly than traditional 
manufacturing technology, may enable the United States to play a larger 
role in pharmaceutical manufacturing. These include initiatives to 
enhance the efficiency of drug manufacturing by utilizing technology 
(such as through the use of 3D printing, miniaturization, continuous 
manufacturing and other techniques). By supporting education for a 
domestic workforce trained in these areas, skilled U.S. workers would 
be able to be part of this emerging trend in drug manufacturing. By 
moving from batch-to-batch production to continuous manufacturing, 
drugs can be produced much more quickly, and the quality is much more 
uniform. As part of the COVID-19 response, the Department has engaged 
companies to help promote domestic manufacturing and additional sources 
of medical products.

    ``Drug Shortages: Root Causes and Proposed Solutions'' responds to 
the request from Congress to convene a task force to study the problem, 
prepare a report on the root causes of drug shortages, and make 
recommendations for enduring solutions. FDA, working in concert with 
the Task Force, fulfilled those objectives. As noted in the report, 
implementing the types of enduring solutions proposed will require 
multi-stakeholder efforts and rethinking of business practices 
throughout the health care system.

    In Appendix D of the report (pages 84-88), CMS raises policy issues 
related to each of their programs.

                                 ______
                                 
                 Questions Submitted by Hon. Ron Wyden
    Question. Please provide the basis for the estimates in the 
President's budget for each of the Medicaid legislative proposals 
including those contained in his ``health reform vision,'' to include 
baseline enrollment, baseline per member per month spending, and 
baseline trend rates, as well as projected changes in enrollment, 
projected per member per month spending, and projected year-to-year 
trend rates, along with all relevant assumptions.

    Answer. In general, estimating the impacts of proposals requires 
various data sources (Medicaid and non-Medicaid), input from health-
care and policy experts on the practical effects of changes to the 
programs, and informed assumptions about their impacts. The exact 
information needed depends heavily on the nature and specifics of the 
proposal. The attached file contains our projected expenditures, 
enrollment, and per enrollee expenditures from the President's FY 2021 
budget. This is the most recent set of projections we have completed, 
and it is important to note that it does not account for any impacts or 
legislation related to COVID-19. We have provided some notes along with 
these figures as well.

    Question. On page 117, the HHS Fiscal Year 2021 Budget in Brief 
states that Proposed Rule (CMS-2421-P) ``will allow States the option 
to conduct more frequent eligibility redeterminations, amongst other 
reforms to improve the integrity of State eligibility determination and 
renewal processes.''

    Will such more frequent redeterminations apply to all populations 
determined financially eligible by the Modified Adjusted Gross Income 
(MAGI) standard, including children and individuals with disabilities?

    Under the proposed rule (CMS-2421-P), how frequently would States 
be allowed to conduct eligibility redeterminations?

    Are there limits or requirements around how States would be able to 
conduct eligibility redeterminations?

    What are the proposed ``other reforms'' in the area of eligibility 
determination and renewal processes referenced in the budget in brief?

    Answer. Current regulations generally prohibit States from 
conducting Medicaid eligibility redeterminations more than once every 
12 months for individuals eligible based on financial criteria. The FY 
2021 budget includes an administrative proposal to remove the 
regulatory restriction limiting a State's ability to determine 
beneficiary eligibility to no more than once every 12 months for 
certain MAGI-eligible groups, absent information about a change in the 
beneficiary's circumstances that may affect eligibility. Such changes 
would allow States the option to more frequently determine whether an 
individual remains eligible for Medicaid or if their income has 
exceeded the income limits.

    HHS has not released the proposed rule ``Strengthening the Program 
Integrity of the Medicaid Eligibility Determination Process'' (CMS-
2421-P). If the Department moves forward with a proposal, we will 
follow standard rulemaking procedure, which includes an extensive 
comment period for public feedback. We welcome input from all of our 
stakeholders as we make important policy decisions to improve our 
programs.

    Question. On page 64, the Fiscal Year 2021 Analytical Perspectives 
budget document States that the President's budget ``proposes to allow 
States flexibility to more frequently assess beneficiary eligibility, 
while clarifying data matching requirements to ensure taxpayer 
resources are not supporting ineligible beneficiaries. This 
administrative proposal saves $17.1 billion over 10 years.''

    What are the clarifying of data matching requirements that you 
refer to?

    What is the year-by-year enrollment decline that is the basis of 
the spending reductions under this proposal, including breakouts by 
eligibility group?

    Answer. Current regulations generally prohibit States from 
conducting Medicaid eligibility redeterminations more than once every 
12 months for individuals eligible based on financial criteria. The FY 
2021 budget includes an administrative proposal to remove the 
regulatory restriction limiting a State's ability to determine 
beneficiary eligibility to no more than once per year, absent 
information about a change in the beneficiary's circumstances that may 
affect eligibility. Such changes would allow States to more frequently 
determine whether an individual remains eligible for Medicaid or if 
their income has exceeded the income limits.

                                 ______
                                 
               Questions Submitted by Hon. Maria Cantwell
                       novel coronavirus outbreak
    Question. In January, the first U.S. case of COVID was found in 
Washington State. Our health department has been working tirelessly to 
protect Washingtonians and prevent further outbreaks. However, 
Washington State has already spent over $1.6 million on response and 
expects significant costs going forward. In early February, CDC sent 
the Washington State Department of Health diagnostic test kits to begin 
testing our own patients for COVID. But the test kits reported 
inconsistent results, requiring the State to use more resources and 
request additional assistance from the CDC. This virus is not only 
affecting the health of people in America and globally--it is taking a 
toll on the economy. In January 2020 alone, Washington State 
experienced a 25-percent drop in Chinese tourism in the Seattle area. 
At this time, we need to ensure that the CDC, our frontline defense, is 
adequately funded.

    The budget includes over $145 million in cuts to CDC programs that 
have been directly responding to the coronavirus outbreak and the 
diagnostic test kit development. Do you think these cuts are in the 
best interest of the American people, who expect an effective response 
to this outbreak and any future infectious disease outbreaks?

    Answer. The President's initial FY 2021 request was formulated with 
consideration to overall budget caps for discretionary spending and 
thus included cuts for many discretionary programs.

    On March 17, 2020, the administration transmitted an FY 2021 budget 
amendment to Congress to increase funding for CDC to ensure that the 
agency had the resources beginning October 1, 2020, to continue its 
critical public health mission. This amendment requested a total FY 
2021 funding level of $8,329,102,000 for CDC, which is $1,328,196,000 
above the FY 2021 budget request. The additional funding would support 
priority CDC activities, including preparedness and response.

    The administration worked closely with Congress to ensure that 
State and local public health departments had necessary resources to 
respond to COVID-19.

    Question. The President has asked you to lead a Coronavirus Task 
Force. However, the Task Force does not include anyone from the 
Department of Defense, USAID, or the Department of Agriculture. Why are 
these agencies not a part of the task force? Do you believe the U.S. 
can properly respond to the COVID outbreak without their participation?

    Answer. The President announced the formation of the Coronavirus 
Task Force on January 29th to help lead the administration's efforts to 
monitor, contain and mitigate the spread of the virus. The Task Force 
is led by Vice President Mike Pence and is coordinated through the 
National Security Council. It is composed of subject matter experts 
from the White House and several other United State Government agencies 
chosen by the White House to lead the overall, whole-of-
government response. Throughout the pandemic, the White House has added 
new members to the Task Force as our response to the pandemic evolved. 
For example, on May 15th, the White House announced new individuals to 
the White House Coronavirus Task Force, including Secretary of 
Agriculture Sonny Perdue.

    The President has a team of experts advising him and overseeing the 
response that is without parallel anywhere in the world, and with the 
leadership of the task force we were able to take early, bold action to 
help stop the spread of the virus and launch Operation Warp Speed.

    Question. The budget proposes to cut over $900 billion in Medicaid 
funding over the next decade including through block grants and caps. 
The administration also continues to attack the Medicaid program 
through State waivers for work requirements. Medicaid plays an 
important role in assisting States and localities in responding to 
public health emergencies, like the COVID outbreak.

    Your new block grant guidance would cap Medicaid funding saying 
that States would have to ask CMS for permission for additional funding 
for a response to a public health emergency with no guarantee that they 
will receive it or that the request will be approved on a timely basis. 
Is it your view that States should have to ask for CMS permission 
before they can respond to a public health crisis like the coronavirus 
or risk being on the hook under this block grant system?

    Assuming CMS approves the additional funding for a public health 
emergency under the Healthy Adult Opportunity waiver, what formula will 
be used to determine the amount of funding States will receive?

    Answer. Federal statute allows, at the request of the Governor of 
an affected State, the President to declare a major disaster or 
emergency if an event is beyond the combined response capabilities of 
the State and affected local governments. Federal law also allows the 
Secretary of Health and Human Services (HHS) to declare that a public 
health emergency exists in the affected State, and authorize waiver or 
modification of certain Medicare (including EMTALA), Medicaid, and CHIP 
requirements under section 1135 of the Social Security Act.

    With a public health emergency and a Presidential declaration in 
effect, there are many things CMS can do to help. For example, the 
Section 1135 waiver determination enables CMS to waive or modify 
certain Medicare, Medicaid, CHIP, Stark Law, and EMTALA requirements, 
including certain deadlines, quality reporting requirements, conditions 
of participation, and certification requirements. During an emergency, 
CMS moves quickly to use the full breadth of the waiver authority to 
maintain access to care for Medicare and Medicaid beneficiaries. In 
addition to waivers, CMS works closely with States, providers, and 
other stakeholders to provide guidance, technical assistance, toolkits, 
and other resources to make sure the people served by our programs 
continue to receive high quality health care even in the face of an 
emergency. As stated in our guidance and recognizing the dynamic 
health-care landscape in which State Medicaid programs are operating, 
CMS will provide States with the opportunity to propose updates to an 
approved HAO demonstration to account for any changes to projected 
expenditures or enrollment in the current demonstration year due to 
unforeseen circumstances out of the State's control, such as a public 
health crisis or major economic event. This ability to modify waivers 
provides CMS with an opportunity to engage States in training, 
technical assistance, and guidance to maximize outcomes, and can help 
CMS and States identify potential new improvements to the unprecedented 
flexibility offered through an HAO waiver.

    Question. Do you disagree with State Medicaid directors, who have 
said that no amount of flexibility you want to give can compensate for 
the magnitude of cuts proposed in the Healthy Adult Opportunity 
waivers?

    Answer. HHS's proposed budget will have Medicaid spending grow at a 
more sustainable rate by ending the financial bias that currently 
favors able-bodied working-age adults over the truly vulnerable.

    The Healthy Adult Opportunity (HAO) is not a mandatory change in 
the Medicaid program's structure or financing--this is an optional 
demonstration opportunity, and no State is under any obligation to 
participate. It is also not permission for States to strip benefits or 
limit eligibility--under HAO, participating States must still meet 
minimum benefit requirements and cannot cap or limit adult enrollment 
while still receiving enhanced Federal funding.

    A number of States have already publicly expressed interest in HAO, 
and are supportive that the demonstration represents an innovative and 
historic approach to surmounting Medicaid's structural challenges while 
still providing rigorous protections for all Medicaid beneficiaries.
                      indian health services (ihs)
    Question. In Washington State, the Indian Health Service is a vital 
health-care provider to tribal and non-tribal communities throughout 
the State. Whether it is one of the six Indian Health Service 
facilities or a self-governance contract with one of our tribes, IHS-
supported health care can be the only health-care option for hundreds 
of miles. It is imperative these providers are funded and the 
facilities can effectively serve patients. Unfortunately, there is 
significant work to do to meet this mission. For example, the IHS Omak 
clinic is situated in a converted modular office building that was 
always intended to be temporary. The current space has limited exam 
room space and severely constrains the number of health providers the 
tribe can offer. The tribe is in need of a new clinic so it can double 
the current number of doctors, dentists, and health providers. A new 
clinic is incredibly important to the tribe and the surrounding 
community because the nearest level 3 emergency room is more than 100 
miles away. However, Washington State has not benefited from IHS 
facility construction programs like the rest of the country. The 
northwest Portland area IHS has had only one joint venture project 
since 1988. I am encouraged that the Colville Confederated Tribes in 
north central Washington are one of 10 finalists nationwide to be in 
the current round of joint venture applications.

    Does HHS have a long-term plan to address IHS facility needs 
outside of the Priority Construction list?

    Answer. IHS understands the health needs of the AI/AN population in 
Washington. The area has had many successes, such as:

        The Yakama facility has been renovated over the last few years 
using Medicaid and Medicare funding.
        The joint venture program is an opportunity for tribes and 
tribal organizations to receive funding to staff and operate a facility 
constructed or acquired by the tribe or tribal organization. 
Specifically, the Coleville application was awarded an opportunity to 
participate. We are looking forward to working with the Coleville 
Confederated Tribes in Omak, WA as they utilize this program.
        Smaller tribes and tribal organizations are able to get 
partial funding through the Small Ambulatory Program (SAP). This 
program selection process is also based on need and small populations 
have struggled with this program. IHS has amended the program to give 
more opportunities for smaller tribes to get awards. These changes will 
begin with the 2020 SAP offering.
        The Portland area IHS is working diligently to determine the 
ability to place an area-wide referral center near Seattle.

    The Indian Health Service (IHS) Health Care Facilities Construction 
program is funded based on an IHS-wide list of priorities for 
construction projects. In the 1990s, the Health Facilities Construction 
Priority System (HFCPS) established one national list that prioritizes 
funding for the top ten inpatient and the top ten outpatient 
facilities. The Indian Health Care Improvement Act (IHCIA) requires 
that ``any project established under the construction priority system 
in effect on March 23, 2010, shall not be affected by any change in the 
construction priority system taking place after that date'' (25 U.S.C. 
Sec. Sec. 1631(c)(1)(D), (g)). The IHCIA ``grandfathered'' the HFCPS 
list, and the methodology used to add projects to the list is no longer 
in use. Appropriations for health care facility construction are 
allocated only to facilities on the HFCPS list until the grandfathered 
priority list completely funded. The 2019 facilities appropriation 
allowed IHS to partially fund all of the remaining projects on the 
grandfathered priority list.

    Pursuant to a congressional request in 2000, the IHS, working with 
tribes, advisory committees, and the Department of Health and Human 
Services, completed a new methodology for a construction project list 
that will go into effect when the grandfathered HFCPS list is 
completed. When the current priority list is completely funded, IHS 
will generate a new list under the new system. One of the aspects of 
the new priority selection process is that it would include an option 
to allocate funds to area offices to address high-priority needs.
                      urban indian health centers
    Question. There are 29 federally recognized tribes in Washington 
State and countless members of tribes from around the country. It is 
our Federal obligation to ensure all Washington State tribes and all 
tribal members have access to health care, no matter where they reside. 
To do this, it is critical tribal health-care providers have the 
recognition and resources they need to serve American Indians and 
Alaska Natives. This includes our urban Indian health-care providers.

    The Seattle Indian Health Board in Washington State is a critical 
health-care provider for urban Native Americans and Alaska Natives 
throughout the Pacific Northwest. The Seattle Indian Health Board 
provides health-care services for about 6,000 patients annually, two 
thirds of whom identify as Native Americans or Alaska Natives from more 
than 250 different tribes. However, urban Indian health programs are 
currently reimbursed at a lower Federal rate for Medicaid patients than 
other federally and tribally operated Indian Health Service facilities. 
This sets critical urban Indian organizations like the Seattle Indian 
Health Board at a financial disadvantage even though they serve a 
population that continues to increase in numbers. That's why I joined 
several of my colleagues in introducing the bicameral Urban Indian 
Health Parity Act to help expand services and improve the quality of 
care for Native Americans and Alaska Natives living in urban areas. 
This legislation gives Urban Indian health-care providers an equal 
voice.

    Are you aware that Urban Indian Health organizations that provide a 
significant amount of health-care services to our tribes in urban 
centers are reimbursed at a lower rate?

    Answer. Although Federal legislation, such as the Social Security 
Act and the Indian Health Care Improvement Act, authorizes urban Indian 
organization (UIOs) to bill and receive payment for the services they 
deliver, only two UIOs have obtained the All-Inclusive Rate (AIR) of 
$479 due to their unique status as Service Units.

    Question. Would you support our Urban Indian Health Organizations 
in receiving parity?

    Answer. IHS continuously assesses options to improve care delivery 
for UIOs.
                         medicaid block grants
    Question. As you know, managed care is the primary manner that 
benefits are delivered in the Medicaid program. Federal rules require 
that payments to plans be made in a way that is sufficient to guarantee 
the plans can pay doctors and hospitals adequately to deliver benefits 
to plan enrollees. CMS's Healthy Adult Opportunity (HAO) program would 
effectively negate those payment rules by eliminating CMS oversight of 
the rates to ensure they are actuarially sound. A Government 
Accountability Office (GAO) report found that some States were not 
complying with Federal actuarial soundness rules and actually 
recommended that CMS increase its oversight of State managed care rate 
setting.

    How do you justify reducing CMS review of actuarially sound rate 
setting in the HAO waivers when GAO has already identified States that 
are not using actuarially fair rates?

    Answer. States utilizing a managed care delivery system to serve 
populations under an HAO demonstration generally will be expected to 
meet the statutory requirements that managed care rates be actuarially 
sound, as well as the regulatory requirements pertaining to the 
development of capitation rates. States will also be expected to 
certify that their managed care plans have the capacity to meet the 
State's standards for access to care and availability of services. 
However, States will have the opportunity under this demonstration to 
adopt alternative approaches to ensuring actuarially sound rates, 
network adequacy, access to care, and availability of services to those 
required under 42 CFR 438.68.

    Regardless of the approach elected, all States implementing an HAO 
demonstration will be required to submit routine data reports to CMS. 
States seeking to implement managed care in a manner that differs from 
the statutory and regulatory requirements also may propose to exercise 
additional flexibilities in the administration of their managed care 
plan contracts, particularly for contract amendments, during the 
demonstration period for an HAO demonstration. A State would be 
expected to submit its initial managed care contracts to CMS for review 
and approval, and to submit subsequent amendments to CMS. Any 
amendments would be expected to be consistent with the terms of the HAO 
demonstration, as well as statutory and regulatory requirements that 
otherwise would apply to Medicaid coverage. CMS will monitor managed 
care contract amendments to ensure compliance with the terms of the 
demonstration and legal requirements. If the monitoring finds that a 
State's managed care contracts are not consistent with the terms of the 
demonstration, CMS would work with the State to bring it into 
compliance before initiating corrective action, which could include 
deferral or disallowance of costs, or termination of the demonstration. 
For States that would prefer the certainty that comes with approval, 
CMS also would allow States to seek formal approval for contract 
changes. Consistent with current requirements, States would be expected 
to incorporate the potential impact of substantive contract amendments 
into the capitation rates paid to managed care plans.

                                 ______
                                 
              Questions Submitted by Hon. Robert Menendez
                                covid-19
    Question. In 2018, the administration reduced the global health 
section at the Centers for Disease Control and Prevention (CDC). What 
impact did this have on the ability of the CDC to respond to the COVID-
19 outbreak?

    Answer. Reductions to CDC's global activities that were reported by 
the press in 2018 were inaccurate. CDC's global health funding in FY 
2018 and FY 2019 was $488.6 million, an increase of $54.5 million over 
the FY 2017 level, including $50 million each year for global health 
security. For over 60 years, CDC has used its scientific expertise to 
help people across the world live healthier, safer, and longer lives. 
CDC works 24/7 to protect Americans and save lives around the world by 
detecting and controlling outbreaks at their source. In addition, CDC 
helps other countries increase their ability to prevent, detect, and 
respond to health threats on their own. CDC's global health 
appropriations include funding for programs in global HIV/AIDS, global 
immunization, parasitic diseases and malaria, and global health 
protection--which includes global health security activities to 
prevent, detect, and respond to infectious disease outbreaks.

    Funds received for global health security in FY 2018 and FY 2019 
were available for multiple years and helped to transition CDC's Global 
Health Security Agenda activities from the original FY 2015 Ebola 
emergency supplemental funding to more stable, annual appropriations. 
In FY 2019, Congress also established the Infectious Diseases Rapid 
Response Reserve Fund with $50 million, and this funding was available 
to prevent, prepare for, or respond to an infectious disease emergency, 
domestic or international. In FY 2020, CDC received an increase of $75 
million to support global health security and an additional $85 million 
for the Infectious Diseases Rapid Response Reserve Fund.

    These investments have enabled CDC to build a stronger foundation 
to help selected partners build core public health capacity across the 
world in disease detection and response. CDC's strong partnerships with 
ministries of health and international partners, have enabled us to 
quickly respond to the outbreak through technical assistance, funding 
in emergency response, laboratory, surveillance, and epidemiology, 
border health and mitigation, infection prevention and control, and 
pandemic and vaccine preparedness planning. With the recent COVID-19 
outbreak, Congress appropriated CDC supplemental funding for global 
disease detection and emergency response: $300 million in Coronavirus 
Preparedness and Response Supplemental Appropriations Act (available 
through September 2022), and $500 million in the CARES Act (available 
through September 2024).

    Question. Are there plans in place to address the existing gaps in 
the administration's global health security teams?

    Answer. As the United States continues to support global health 
security as a priority for national and economic security, the U.S. 
government has been able to demonstrate strong leadership globally to 
advance health security priorities through a collaborative and 
multisectoral approach. Using the Global Health Security Agenda (GHSA) 
as a premier model of global health security engagement, these efforts, 
as outlined in the U.S. Global Health Security Strategy, focus on 
strengthening partner country capacities to prevent, detect, and 
respond to infectious disease threats, increasing international support 
for global health security, and ensuring a homeland prepared for, and 
resilient against, health threats.

    The U.S. Government approach to advance global health security 
priorities involves a truly government-wide approach that draws on the 
unique roles and strengths of many departments and agencies both at 
headquarters and in-country, including the Departments of Health and 
Human Services, State, Defense, and Agriculture, the Centers for 
Disease Control and Prevention, and the U.S. Agency for International 
Development, among others. Globally, this whole-of-government approach 
supports GHSA through U.S. leadership in the multilateral GHSA 2024 
initiative, which galvanizes commitment and action by other countries 
and advances priorities such as sustainable financing, and through 
bilateral technical collaborations with key GHSA partner countries, 
which addresses critical gaps and builds valuable partnerships.

    The GHSA Annual Report for 2020 (https://www.state.gov/wp-content/
uploads/2020/09/GHSA_ProgressImpactFY19_final.pdf) provides many 
concrete examples of what U.S. Government technical and financial 
support has done to help countries and partners achieve progress and 
the evidence of impact. Although this report covers progress prior to 
the COVID-19 pandemic, we do highlight in it the strong linkages 
between GHSA progress and COVID-19 response. Pre-COVID-19 capacity-
building efforts supported by the U.S. Government have been leveraged 
extensively by our partner countries to support their response efforts. 
We will continue to publish these annual reports on progress that 
highlight examples of life-saving capacity-building work and related 
progress to strengthen national, regional, and global health security.

    Question. Do you believe the FY 2021 budget's cuts to the CDC, in 
particular to the Public Health Emergency Preparedness Cooperative 
Agreement, CDC Preparedness and Response, Public Health Workforce are 
shortsighted in light of the ongoing global health threats that 
continue to emerge?

    Answer. The President's initial FY 2021 request was formulated with 
consideration to overall budget caps for discretionary spending and 
thus included cuts for many discretionary programs. In March of this 
year, the administration submitted a revised request for CDC that would 
have provided an additional $1.329 billion for the agency, an amount 
exceeding CDC's FY 2020 annual appropriation.

    Question. What additional investments must the United States make 
in public health infrastructure to address gaps in our response 
capabilities?

    Answer. The COVID-19 pandemic put a spotlight on the needs and 
disparities in public health infrastructure and highlighted the 
importance of public health-care capabilities across the country and 
throughout the world. These core capabilities form the backbone of 
CDC's capacity to protect America's health. A strong public health 
system includes robust data and analytics, laboratory capacity, a top-
tier workforce, rapid response capabilities and a broad global 
footprint to stop disease at its source. The administration worked 
closely with Congress to ensure that State and local public health 
departments had necessary resources to respond to COVID-19. The 
investments supported with COVID-19 Supplemental funds will help 
improve public health infrastructure at all levels across the country, 
including: (1) improvements to national health data infrastructure to 
allow for rapid bi-directional exchange of critical information between 
local, State, and Federal public health systems and health care 
systems; (2) lab capacity expansion to enable increased testing by 
State and local health departments, the frontline for detection for the 
public health system in the United States; (3) supporting a robust, 
deployable, and flexible workforce to trace and monitor contacts of 
infected people, support the quarantine of contacts, and use tools to 
expand the reach and efficacy of contact tracers; and (4) the creation 
of a national preparedness and response culture in which public health 
entities learn and continuously optimize practices with direct staff 
bidirectional engagement and assistance.

    Question. You recently stated there are 20 drugs made in China that 
have no substitutes, what can be done going forward to better secure 
our supply chain against reliance on foreign sole-source suppliers?

    Answer. By supporting the growth of advanced manufacturing in the 
United States, we can reduce our dependence on China and other overseas 
manufacturers for APIs (Active Pharmaceutical Ingredients) as well as 
improve the resilience and responsiveness of our manufacturing base and 
reduce drug shortages.

    Advanced manufacturing offers many advantages over traditional 
pharmaceutical manufacturing, and if the United States invests in this 
technology, it can be used to reduce the Nation's dependence on foreign 
sources of APIs, increase the resilience of our domestic manufacturing 
base, and reduce quality issues that trigger drug shortages or recalls. 
For example:

        Product quality can be precisely controlled with modern 
automation and control systems and can be closely monitored during 
production by using high-resolution analytics.
        High technology, computer-controlled production facilities are 
better able to rapidly respond to changes in demand because they 
typically do not have the equipment scale-up issues associated with 
traditional methods and can be capable of seamlessly producing a 
variety of dosages and even dosage forms.
        Advanced manufacturing platforms also have a much smaller 
footprint than traditional manufacturing platforms, and the equipment 
can be made portable so that it can be moved closer to markets, 
reducing the need for transcontinental shipping of components.
        Medicines can be produced at lower cost than by traditional 
methods.
        Environmental impact of manufacturing is significantly 
reduced.

    Restricting the supply chain of pharmaceutical products from a 
specific country or region may have the unintended consequence of 
reducing redundancy in the supply chain and creating significant 
shortages of critical drug products. It may overlook other issues 
impacting supply chain availability, such as sole-source drugs 
manufactured in other regions. For these reasons, as a matter of 
course, the agency's primary focus is on instilling redundancy in the 
supply chain of pharmaceuticals by diversifying the supply chain and 
looking for opportunities to encourage domestic manufacturing.

    We note that investments in advanced manufacturing technology and 
in strengthening the approach by which manufacturers assure the quality 
of their products can provide a safer and more secure drug supply chain 
and may promote domestic pharmaceutical manufacturing. Advanced 
manufacturing can be more cost-effective and environmentally friendly 
than traditional manufacturing technology and help prevent many quality 
problems from occurring in the first place.

    As part of the COVID-19 response, the Department has engaged 
companies to help promote domestic manufacturing and additional sources 
of medical products.

    In October 2019, the Drug Shortages Task Force released a report to 
Congress, Drug Shortages: Root Causes and Potential Solutions. The 
report found that in the United States, economic factors are the 
primary drivers of drug shortages. These factors relate to: limited 
incentives for drug manufacturers to produce certain drugs, i.e., those 
with low profitability; market does not recognize and reward mature 
quality management systems used to ensure supply reliability; and 
logistical and regulatory factors that make it expensive and time 
consuming for manufacturers to increase supply of a drug after a 
disruption occurs.
                               gun safety
    Question. The CDC considers its own data on non-fatal firearm 
injuries ``unstable and potentially unreliable.'' This makes it 
impossible to propose or study various programs and policies aimed at 
preventing gun deaths and injuries, including those among children. 
Recent budget allocations have increased support to improve upon the 
National Violent Death Reporting System (NVDRS), but how, specifically, 
will the CDC work to improve nonfatal firearm injury surveillance and 
reporting in 2020?

    Answer. CDC strives to provide the most timely, accurate data 
available--including data related to firearm injuries. A number of data 
systems exist that researchers have used to examine firearm injuries. 
CDC provides information on non-fatal injuries, including those related 
to firearms, on its publicly facing Web-based Injury Statistics Query 
and Reporting System (WISQARS). The underlying data WISQARS uses to 
provide this information comes from the National Electronic Injury 
Surveillance System--All Injury Program (NEISS-AIP). A key strength of 
using NEISS-AIP for WISQARS is that it captures emergency department 
visits for all injuries (such as falls or self-harm), and it is not 
specific to firearm-related visits. Additionally, it is usually more 
timely data than many other existing data sources, captures key 
narrative information on factors such as intent directly from the 
medical record, and is not dependent on administrative codes which 
often results in loss of more granular, contextual information. WISQARS 
will no longer show nonfatal national estimates that fail to meet 
strict quality standards. The suppression criteria are (1) fewer than 
20 cases (unweighted data), (2) national estimates less than 1,200 
(weighted data), or (3) when the estimate's coefficient of variation 
(CV) is greater than 30 percent.

    NEISS-AIP data are collected through an inter-agency agreement with 
the Consumer Product Safety Commission (CPSC) and represent a sub-
sample of about \2/3\ of the National Electronic Injury Surveillance 
System (NEISS). The data collected from selected hospitals are used to 
estimate national numbers. CDC is currently working with CPSC to look 
at the number and types of hospitals participating in NEISS and NEISS-
AIP. CPSC is utilizing an independent contractor to evaluate sampling 
methods, methods for re-sampling if hospitals drop out, and how to best 
address the variance of the estimates, including increasing the size of 
the NEISS-AIP sample. Understanding these factors will help identify 
strategies that may improve the stability of estimates in the future. 
The final report from the contractor is anticipated at the end of 
September 2020. Once complete, CPSC staff will review the assessment 
and work with CDC and other Federal partners to determine next steps.

    CDC is also undertaking efforts to strengthen nonfatal firearm 
injury data at the local and State level through the Firearm Injury 
Surveillance Through Emergency Rooms (FASTER) NOFO. CDC is funding 10 
State health departments as part of the competitively funded FASTER 
NOFO to provide surveillance data in near-real time on emergency 
department visits for nonfatal firearm injuries. Syndromic surveillance 
has the potential to address two key gaps in nonfatal firearm injury 
data: first, it can provide data in near-real time on nonfatal firearm 
injury that is currently not available from other data systems, which 
typically have a 2-3 year lag time before information is available. 
Second, it can provide local data on nonfatal firearm injuries that is 
currently not widely available.

    The first year of FASTER is funded with FY2020 money appropriated 
to CDC for firearm injury and mortality prevention research. CDC 
intends to fund 10 recipients. FASTER recipients were recently 
announced. Information about FASTER and the recipients are posted on 
CDC's website: https://www.cdc.gov/violence
prevention/firearms/funded-surveillance.html.

    Question. You correctly tweeted that ``suicide is one of the 
leading causes of death in the United States and is on the rise.'' 
Firearm suicide makes up half of all suicide, claiming the lives of 
nearly 23,000 Americans every year, including over 1,100 children and 
teens.

    The data shows that the choice of means for suicide matters. 
Firearms have a fatality rate of approximately 90 percent. Conversely, 
only 4 percent of people who attempt suicide using other methods will 
die.

    There are proven, effective methods to address access to lethal 
means and reduce suicide, including practicing secure gun storage and 
utilizing extreme risk laws that provide a method for families and law 
enforcement to temporarily prevent access to guns for someone who is in 
crisis.

    Please describe what the Substance Abuse and Mental Health Services 
Administration (SAMHSA), Centers for Disease Control (CDC), and 
National Institutes of Health (NIH) are doing to confront the firearm 
suicide crisis, including: how is lethal means counseling about firearm 
access integrated into programs supported by SAMHSA, including the 
National Suicide Prevention Hotline?

    Answer. The National Suicide Prevention Lifeline incorporates 
lethal means assessment and counseling into its expectations for 
participating crisis centers in the Lifeline network. All Lifeline 
centers sign a network agreement and agree to the Lifeline's Standards 
for Suicide Risk Assessment and Guidelines for Callers at Imminent 
Risk. The Standards for Suicide Risk Assessment includes, as one of its 
components, assessing for available means to die by suicide, including 
firearms. In addition, when responding to callers at imminent risk, 
crisis centers are expected to try to work collaboratively on a variety 
of potential ways to reduce the risk, including taking steps to 
minimize the availability of lethal means. The Lifeline also provides a 
simulation training that incorporates assessing and counseling on 
accessibility of lethal means. The SAMHSA funded Suicide Prevention 
Resource Center has created an online course, Counseling on Access to 
Lethal Means, which has been widely used across SAMHSA's suicide 
prevention grant program. In addition, SAMHSA's Zero Suicide grants 
also require engagement of those with identified suicide risk in 
collaborative safety planning including reducing access to lethal 
means.

    With FY2020 funds appropriated by Congress, CDC is supporting 
scientific research to understand and prevent firearm-related injuries, 
deaths and crime. Two research funding opportunities will be awarded by 
September 30, 2020. The first opportunity is Research Grants to Prevent 
Firearm-Related Violence and Injuries (R01): RFA-CE-20-006. The second 
research funding opportunity is Grants to Support New Investigators in 
Conducting Research Related to Preventing Interpersonal Violence 
Impacting Children and Youth (K01): RFA-CE-20-002.

    CDC will make information on this research publicly available 
through the NIH Reporter (https://projectreporter.nih.gov/
reporter.cfm). Descriptions of each funded study will also be available 
on CDC's website at https://www.cdc.gov/violenceprevention/firearms/
funded-research.html.

    CDC is also funding eight States and one university to implement 
and evaluate a comprehensive public health approach to suicide 
prevention with a focus on vulnerable populations. To support this 
program, CDC is committing approximately $7 million in FY 2020. The 
purpose of this program is to implement and evaluate a public health 
approach to suicide prevention, with attention to vulnerable 
populations that account for a significant proportion of the suicide 
burden and have suicide rates greater than the general population.

    Question. How does SAMHSA educate families about the need for 
secure gun storage to ensure children and teens cannot access a family 
firearm?

    Answer. SAMHSA helped develop and supports the National Strategy 
for Suicide Prevention. Goal 6 of the National Strategy is to ``promote 
efforts to reduce access to lethal means of suicide among people with 
identified suicide risk.'' SAMHSA's National Strategy for Suicide 
Prevention grants also include in the Funding Opportunity Announcement 
a requirement to ``incorporate efforts to reduce access to lethal means 
among individuals with identified suicide risk.'' This effort will be 
done consistently with all applicable Federal, State, and local laws. 
SAMHSA's Zero Suicide grants also require engagement of those with 
identified suicide risk in collaborative safety planning including 
reducing access to lethal means. SAMHSA suicide prevention grantees 
have also worked collaboratively with firearm retailers in a program 
called the ``Gun Shop Project.''

    Question. Does the administration supports extreme risk laws as a 
way to prevent suicide?

    Answer. Yes, the administration supports these laws as it relates 
to the health and safety of Americans in mental health crisis. An 
examination of the use of these laws as a best practice in mitigating 
self-harm or harm to others was a key component/recommendation of the 
administration's Federal Commission on School Safety report. This 
Commission was implemented by President Trump following the tragic 
school shooting in Parkland, FL.

    As a component of this report, both the Department of Health and 
Human Services and the Department of Justice reviewed extreme risk 
protective orders as a means of mitigating gun violence. These laws 
should have in place procedures to clearly report a concern to the 
authorities regarding access to lethal means by someone who may be 
having a mental health crisis.

    Question. How SAMSHA makes families and law enforcement aware of 
extreme risk laws in the 17 States and District of Columbia that have 
these laws on the books?

    Answer. SAMHSA suicide prevention grantees have the option of using 
funds to increase awareness of extreme risk protective orders.

    Question. What research is being conducted by the CDC and NIH on 
firearm suicide and prevention?

    Answer. With FY2020 funds appropriated by Congress, CDC is 
supporting scientific research to understand and prevent firearm-
related injuries, deaths and crime. Two research funding opportunities 
will be awarded by September 30, 2020. The first opportunity is 
Research Grants to Prevent Firearm-Related Violence and Injuries (R01): 
RFA-CE-20-006. The second research funding opportunity is Grants to 
Support New Investigators in Conducting Research Related to Preventing 
Interpersonal Violence Impacting Children and Youth (K01): RFA-CE-20-
002.

    CDC will make information on this research publicly available 
through the NIH Reporter (https://projectreporter.nih.gov/reporter.cfm) 
after the estimated start date, September 30, 2020. Descriptions of 
each funded study will also be available on CDC's website at https://
www.cdc.gov/violenceprevention/firearms/funded-research.html.

    CDC is also funding eight States and one university to implement 
and evaluate a comprehensive public health approach to suicide 
prevention with a focus on vulnerable populations. To support this 
program, CDC is committing approximately $7 million per year for 5 
years. The purpose of this program is to implement and evaluate a 
public health approach to suicide prevention, with attention to 
vulnerable populations that account for a significant proportion of the 
suicide burden and have suicide rates greater than the general 
population.
                       graduate medical education
    Question. The budget proposes to consolidate Medicare GME, Medicaid 
GME, and CHGME into a single capitated program. Can you please provide 
more information on the justification for this change?

    How will this consolidation into a single GME program, combined 
with a $52 billion reduction in support for teaching hospitals, address 
the growing physician shortage?

    Answer. Current graduate medical education funding is outdated, 
overly broad, and not sustainable in the long term due to its 
fragmented nature across multiple funding streams and lack of 
transparency and accountability. Effective in FY 2021, this proposal 
would consolidate Federal graduate medical education spending from 
Medicare, Medicaid, and the Children's Hospital Graduate Medical 
Education Program into a single grant program for teaching hospitals. 
Total funds available for distribution in FY 2021 would equal the sum 
of Medicare and Medicaid's 2017 payments for graduate medical 
education, plus 2017 spending on Children's Hospital Graduate Medical 
Education, adjusted for inflation. This amount would then grow at the 
CPI-U minus one percentage point each year. Payments will be 
distributed to hospitals based on the number of residents at a hospital 
(up to its existing cap) and the portion of the hospital's inpatient 
days accounted for by Medicare and Medicaid patients. The new grant 
program will be jointly operated by the Administrators of CMS and the 
Health Resources and Services Administration.

    This grant program would be funded out of the general fund of the 
Treasury. The Secretary would have authority to modify the amounts 
distributed based on the proportion of residents training in priority 
specialties or programs (e.g., primary care, geriatrics) and based on 
other criteria identified by the Secretary, including addressing 
health-care professional shortages and educational priorities. These 
changes would modernize graduate medical education funding, making it 
better targeted, transparent, accountable, and more sustainable.
                        remain in mexico policy
    Question. Does the Department of Homeland Security (DHS) 
affirmatively provide the Office of Refugee Resettlement (ORR) with 
information that a child's parent or other relative is in Migrant 
Protection Protocols (MPP), as well as that person's identifying 
information, when transferring the child from DHS to HHS custody?

    What information would ORR like to have from DHS if a child has 
been affected by MPP?

    Answer. In some instances the Department of Homeland Security (DHS) 
provides information regarding an unaccompanied alien child's (UAC) 
previous enrollment in the Migrant Protection Protocols (MPP) at the 
time of the UAC's referral. In other cases, ORR may discover that a UAC 
or the UAC's parents were previously processed under MPP during the 
UAC's admission into an ORR care provider through interviews with the 
child or the child's family, or while the child undergoes assessments 
at a later point. ORR seeks the following information from DHS after 
determining a child may have been enrolled in MPP: UAC and parent(s) 
biographical information; UAC and parent(s) country of origin; alien 
number; location of the UAC and parent(s) at the time they were 
classified as MPP cases; Notice to Appear (NTA); and, immigration court 
date, if applicable.

    Question. What mechanism is ORR using to identify and track 
children affected by MPP? How many children does ORR believe are 
currently in its custody who have a parent or family member in MPP?

    Answer. ORR has procedures to track and coordinate the care of 
children in the UAC program who are subject to MPP. Once ORR discovers 
that a UAC is subject to MPP, either through the intakes process or 
during the child's assessment, the ORR/Division of Unaccompanied 
Children's Operations (ORR/DUCO) case management team works with both 
the ORR/DUCO intakes team and ORR care providers to compile a list of 
all identified MPP cases. Every week, the ORR case management team 
sends the compiled master tracker list to DHS Immigration and Customs 
Enforcement (ICE) Juvenile and Family Residential Management Unit for 
further verification and additional information. Additionally, 
information regarding MPP cases are also entered as a Significant 
Incident Report (SIR) in the UAC Portal, ORR's UAC database.

    Question. How many children does ORR believe have ever been in its 
custody who have a parent or family member in MPP?

    Answer. As of August 31, 2020, there have been 624 UAC in ORR care 
whose parent(s) or legal guardian(s) were previously processed under 
MPP.

    Question. How many of those children are under age 12? How many are 
infants, if any?

    Answer. There were a total of 237 children under the age of 12. 
Specifically, a total of seven UAC were under 24 months of age; of 
those, only two children were under the age of 1. As of August 31, 
2020, 30 UAC whose parents were processed under the MPP remain in ORR 
care.

    Question. There are a number of reports documenting that children 
with serious health conditions are being subjected to MPP and that the 
discretionary medical exemption is not being used. Does HHS have a role 
in advising DHS decisions to grant medical exemptions to MPP?

    Answer. The processing of MPP cases is under the sole purview of 
DHS's Customs and Border Protection. ORR respectfully defers to DHS for 
the response to this question.

    Question. How many children with a parent or family member in MPP 
are currently in ORR care with a disability or serious health 
condition?

    Answer. Seven UAC with a parent or family member enrolled in MPP 
who are currently in ORR care (as of September 10, 2020) have 
significant health concerns or disabilities. These are medical 
conditions that fall under the spectrum of chronic medical issues or 
disabilities as opposed to acute serious medical concerns.

    Question. How many children total does ORR believe have been in its 
custody with a disability or serious health condition with a parent or 
family member in MPP?

    Answer. ORR collects information about significant health 
conditions or disabilities in narrative form in individual UAC case 
files. Compiling this information for close to 600 cases will take 
significant time. HHS can work with committee staff on the most 
expeditious way to provide this information or provide it on a rolling 
basis.

    Question. What changes has ORR made to its regular practices to 
facilitate communication between a child and his or her parent in MPP 
who likely have limited access to phones and/or electricity while in 
Mexico?

    Answer. ORR policy requires that UAC be provided the opportunity to 
make a minimum of two telephone calls per week (10 minutes each) to 
family members in a private setting. For more information on this 
policy and other policies regarding communication please see ORR Policy 
Guide, section 3.3.10 Telephone Calls, Visitation, and Mail, available 
here: https://www.acf.hhs.gov/orr/resource/children-entering-the-
united-states-unaccompanied-section-3#3.3.10. ORR care providers 
exhaust all the necessary avenues to facilitate UAC communication with 
their parents/relatives, including contacting shelters in Mexico, the 
Red Cross, and relatives in their home country, in Mexico, and in the 
United States.

    Question. Does HHS assess children with a parent in MPP with the 
same health and education screenings it would provide to any other 
unaccompanied child?

    Answer. Yes. Each UAC that enters ORR custody receives an initial 
medical examination (IME) conducted by a licensed primary care provider 
(e.g., physician, physician assistant, or nurse practitioner) within 
two business days of arrival to an ORR shelter. The IME is based on a 
well-child examination, adapted for the unaccompanied alien children 
population with consideration of screening recommendations from the 
American Academy of Pediatrics, the Centers for Disease Control and 
Prevention, and the U.S. Preventive Services Task Force. Furthermore, 
ORR complies with all minimum standards set forth by the Flores 
settlement agreement. ORR provides educational services appropriate to 
the UAC's level of development and communication skills. For more 
information on services provided to UAC in ORR custody please refer to 
the ORR Policy Guide, section 3.3 Care Provider Required Services 
available at: https://www.acf.hhs.gov/orr/resource/children-entering-
the-united-states-unaccompanied-section-3#3.3; and section 3.4 Medical 
Services available at: https://www.acf.hhs.gov/orr/resource/children-
entering-the-united-states-unaccompanied-section-3#3.4.

    Question. At what point is a child identified as having a parent in 
MPP returned to Mexico? What is the process for returning the child to 
Mexico?

    Answer. The majority of UAC who have been processed under MPP by 
DHS have been released to their vetted sponsors in the United States. 
In cases where repatriation to Mexico occurred, ORR coordinated with 
DHS on the repatriation efforts. Each case is unique and ORR 
coordinates extensively with DHS to determine the best approach for 
reuniting a child with a parent or legal guardian in these types of 
circumstances. In some cases, a UAC may request voluntary departure to 
return to their home country and be reunited with a parent, if the 
parent opted to return to their home country instead of remaining in 
Mexico. In other cases, DHS can cancel the NTA and allow reunification 
with a parent to occur at the border.

    Question. Has HHS made any determinations that it was not safe for 
a child to be returned to his or her family in Mexico? If so, please 
provide the details of that assessment.

    Answer. HHS does not make determinations on the safety of 
immigration cases, HHS respectfully defers this question to DHS or to 
the U.S. Department of Justice/Executive Office for Immigration Review 
(EOIR), the agency responsible for overseeing the U.S. immigration 
courts.
                           family separation
    Question. What further improvements have been made to the UAC 
system to improve the tracking of children who have been separated from 
his or her parents and the basis for separation? How is that 
information communicated to legal service providers and child 
advocates?

    Answer. ORR has several mechanisms for tracking UAC separated from 
an adult by DHS. ORR added a checkbox to the UAC Portal that is marked 
for any UAC separated from a parent or legal guardian, and can be used 
as means to quickly identify known separations for data reporting 
purposes. In addition, for children transferred to ORR custody 
subsequent to their separation from a parent or legal guardian, 
documentation of that separation is entered in the UAC Portal upon ORR 
learning of the separation (e.g., through the creation of an SIR). This 
information is included in the UAC's case file as part of recording the 
UAC's experiences during their journey to the United States and 
placement in an ORR care provider facility. On a weekly basis, ORR 
communicates with Customs and Border Protection (CBP) as well as ICE 
staff to jointly reconcile a running list of children from their 
parents/legal guardians.

    On a weekly basis, ORR communicates with ICE staff to jointly 
reconcile a running list of children separated from their parents or 
legal guardians. On a monthly basis, the list is further reconciled 
through consultation with CBP at the operator level and vetted for 
release to plaintiffs' counsel in ongoing litigation. These lists 
include information relating to reasons for the separation as provided 
by DHS. However, this information often requires reconciliation and 
vetting through communication between HHS and DHS. Through these 
mechanisms, ORR continues to monitor children separated from their 
parent or legal guardian and document when separations from their 
parents are brought to ORR's attention.

    All UAC in ORR custody meet with legal service providers (LSP) 
shortly after their placement in ORR custody. ORR notifies the LSP of a 
UAC separated from their parent after initial assessments are conducted 
and when possible, prior to the child's legal screening provided by the 
LSP. Child advocates are notified upon request or when appointed to a 
specific UAC in accordance with section 2.3.4 of the ORR Policy Guide 
available here: https://www.acf.hhs.gov/orr/resource/children-entering-
the-united-states-unaccompanied-section-2#2.3.4.

    Question. Does DHS always inform HHS of a family separation at the 
time of the child's referral to HHS custody? Does HHS receive specific 
details from DHS about reasons for separation at the time a child is 
transferred?

    Answer. HHS is not always informed of a family separation at the 
time of the UAC's referral. However, in some cases, DHS indicates that 
a child has been separated from a parent or legal guardian and includes 
that information in the referral note. Once HHS finds out about a 
separation, it requests further information from DHS about the specific 
details related to the separation such as the separated parent(s)' 
name, alien number, and reason for separation. As noted in the previous 
question, ORR communicates with DHS on a weekly and monthly basis to 
jointly reconcile a running list of children separated from their 
parents or legal guardians. These lists include information relating to 
reasons for the separation as provided by DHS. However, this 
information often requires reconciliation and vetting through 
communication between HHS and DHS.

    For any UAC, including those separated from an adult that is not 
child's parent or legal guardian, the ORR care provider includes 
information of that separation in the UAC's case file as part of 
recording the child's experiences during their journey to the United 
States and placement in an ORR care provider facility. ORR recognizes 
the oversight responsibilities of Congress and submits, as required by 
law, a monthly report to Congress on children separated from their 
parents or legal guardians by DHS and referred to ORR custody. This 
report includes, for example, the demographics of separated children as 
outlined in Senate Report 115-289. Each monthly report on separated 
children is available on HHS's website here: https://www.hhs.gov/
programs/social-services/unaccompanied-alien-children/index.html.
                      firefighter cancer registry
    Question. Can you provide an update on the implementation of the 
Firefighter Cancer Registry? In particular, does the program have 
sufficient funding to meet the program's goals?

    Answer. The National Institute for Occupational Safety and Health 
(NIOSH) National Firefighter Registry team met with and presented to 
over 30 fire departments, fire service organizations, incident record 
management companies, State cancer registries, and researchers to 
receive input and fully understand research gaps and needs. A website 
for the National Firefighter Registry was also established 
(www.cdc.gov/NFR). A prototype for the registration web portal was 
developed to focus on optimizing user experience prior to 
implementation. The NIOSH team prepared an application for an Assurance 
of Confidentiality (AoC), which is the highest level of protection 
available for identifiable data and includes a secure mechanism for 
sharing de-identified data with external researchers. The approval 
process is expected to begin in FY 2021.

    The NIOSH National Firefighter Registry team created an overall 
plan for the National Firefighter Registry (NFR), called a protocol, 
which included recruitment plans, the voluntary consent form, and 
enrollment questionnaire. It laid the foundation for how the registry 
would function and operate.

    In addition, the National Firefighter Registry Subcommittee (NFRS) 
was formed. This group of 13 experts comprised of active and former 
firefighters, emergency response associates, public health experts, 
epidemiologists, scientific advisors, clinicians and State departments 
of homeland security met twice and reviewed the draft protocol (https:/
/www.cdc.gov/niosh/bsc/nfrs/pdfs/DFSE_NI_NFR_Protocol_Draft
-CLEARED-508.pdf). After a careful review of the protocol, the NFRS 
published a report with advice and recommendations (see https://
www.cdc.gov/niosh/bsc/nfrs). The NFRS discussed and finalized the 
report with CDC/NIOSH's Board of Scientific Counselors (BSC).

    Based on this report, and additional input from fire service and 
research stakeholders, the NIOSH team made further enhancements to the 
NFR protocol, questionnaire, and supporting materials. To add to the 
team, a full-time health communication specialist was hired and a 
communications plan for firefighters has been drafted. This plan is 
currently being tested with a variety of firefighters in virtual focus 
groups.

    Question. What steps are the Centers for Disease Control and 
Prevention taking to ensure that the registry reflects the diversity of 
the firefighting profession, including women, minorities and 
volunteers?

    Answer. The NIOSH team established partnerships with key 
stakeholder groups, which included meeting with Women in Fire, the 
National Association of Hispanic Firefighters, and the National 
Volunteer Fire Council (NVFC) to raise awareness and seek input on the 
NFR. Additionally, a presentation on the NFR is scheduled for Women in 
Fire's November virtual conference. Focus groups have been scheduled 
with panels of female and Hispanic firefighters to discuss the 
communications plan and materials as they relate to reaching female and 
minority populations.

    A promotional campaign contract was recently awarded to focus on 
communication and recruitment of a diverse sample of firefighters. The 
NIOSH team published an article in NVFC's publication ``Firefighter 
Strong,'' which is mailed to all U.S. fire departments (https://
www.nvfc.org/latest-issue-of-firefighter-strong-now-available/). A 
sampling design was also included in the NFR protocol that includes a 
focused component specifically targeting fire departments with large 
female, minority, and volunteer workforces.

                                 ______
                                 
              Questions Submitted by Hon. Thomas R. Carper
    Question. The President's budget cuts more than $1 trillion from 
Medicaid and other safety net programs that support millions of low-
income Americans with food, heating, community and social services over 
the next decade. Since Medicaid is the largest payer for substance 
abuse treatment and covers roughly one in two pregnancies, these cuts 
to safety net programs far exceed any additional investments the budget 
outlines for addressing the opioid epidemic, mental health needs, or 
maternal health. What do you project to be the change in Medicaid 
enrollment as a result of these cuts? What do your department's 
analyses show about the effect of the Medicaid cuts on access to 
substance abuse treatment, mental health care, and maternal health 
care?

    Answer. Medicaid plays a pivotal role in ensuring access to 
quality, affordable health care for the most vulnerable Americans. The 
FY 2021 budget does not propose cutting Medicaid, but rather maintains 
funding to at least FY 2020 levels and slows annual growth of the 
program from 5.4 percent to 3.1 percent. HHS's proposed budget will 
have Medicaid spending grow at a more sustainable rate by ending the 
financial bias that currently favors able-bodied working-age adults 
over the truly vulnerable. This administration is committed to 
providing States with additional program financing options that will 
create opportunities for States to invest in their health-care 
infrastructure.

    Question. The United States and a growing number of countries have 
identified increasing cases of the coronavirus. What statutory changes 
are needed to increase CDC and public labs' capability and speed to 
test potential patients for the coronavirus?

    Answer. It is important to note that commercial diagnostic labs 
have primary responsibility for large scale diagnostic testing after 
the initial phase of the response to a large-scale outbreak involving a 
novel pathogen. Early in a response, CDC plays a key role in aiding and 
equipping State public health laboratories to gain the independent 
capacity to conduct diagnostic testing for the pathogen. However, 
commercial diagnostic manufacturers are necessary to provide large-
scale diagnostic testing for clinical purposes and to meet the needs of 
the entire health-care system. Ideally, public health laboratory 
testing capacity ramps up quickly and in parallel with large-scale 
commercial capacity, so that both the public health and health-care 
systems have the diagnostic capabilities needed.

    The administration worked closely with Congress to ensure that 
State and local public health departments had necessary resources to 
respond to COVID-19. The investments supported with COVID-19 
Supplemental funds will help improve public health infrastructure at 
all levels across the country, including lab capacity expansion to 
enable increased testing by State and local health departments, the 
frontline for detection for the public health system in the United 
States.

    Question. As much as 80 percent of one's health outcomes are 
effected by social determinants of health, such as access to clean 
water or having an air filter to help asthma. This is particularly true 
with Medicaid beneficiaries who are low-income. We know that addressing 
the root causes of unmet health care needs can improve overall health 
outcomes and, ultimately, lower costs for patients and providers, 
including the government. Medicare Advantage plans already have the 
flexibility to cover services to address social determinants of health. 
Is CMS collecting information from Medicare Advantage plans on the 
clinical and cost effectiveness of these services? What are your 
recommendations for providing seniors in fee-for-service Medicare with 
similar access to services that address social determinants of health?

    Answer. Social determinants of health can include housing, 
transportation, education, social isolation, and more. These factors 
affect access to care and health care utilization as well as outcomes. 
As we seek to foster innovation, rethink rural health, find solutions 
to the opioid epidemic, and continue to put patients first, we need to 
take into account social determinants of health and recognize their 
importance.

    Addressing the social determinants of health begins with 
identifying a patient's socioeconomic and environmental conditions and 
measuring the impact of those conditions on individual and community 
health. Organizations may measure these factors using a number of 
existing tools that can help in the identification process, including:

        Z codes from in the International Classification of Diseases 
(ICD-10-CM), which are a group of codes within the ICD-10 (diagnostic) 
codes that help clinicians capture a patient's socioeconomic and/or 
psychosocial needs (examples of Z-codes in table below),
        Accountable Health Communities (AHC) Health-Related Social 
Needs Screening Tool, which is used by organizations participating in 
the CMS AHC model to identify health-related social needs.
        PRAPARE tool (Protocol for Responding to and Assessing 
Patients' Assets, Risks, and Experiences), developed by the National 
Association of Community Health Centers for providers to collect the 
data needed to better understand and act on their patients' social 
determinants of health, and
        Health Leads Screening Toolkit, which is intended to be used 
by clinicians as a comprehensive way to assess patients for adverse 
social determinants.

    Data collection will help us strengthen our understanding of the 
relationship between social determinants of health and health-care use 
across diverse populations, allowing us to develop solutions and better 
connect patients to much needed services. CMS has begun this effort in 
several post-acute care provider settings this year by requiring that 
some data elements be collected on standardized patient assessment 
instruments. Some of the data elements are derived from questions from 
the Accountable Health Communities and PRAPARE tools mentioned above.

    In an effort to reduce expenditures and improve health outcomes, 
CMS is testing the Accountable Health Communities Model, which is the 
first model to include social determinants of health. The model is 
based on emerging evidence that shows addressing health-related social 
needs through enhanced clinical-community links can improve health 
outcomes and reduce costs.

    Medicare Advantage plans can offer expanded types of supplemental 
benefits to chronically ill enrollees, Special Supplemental Benefits 
for the Chronically Ill (SSBCI). Medicare Advantage plans can provide 
SSBCI which may include non-
primarily health related supplemental benefits that address chronically 
ill enrollees' social determinants of health so long as the benefits 
have a reasonable expectation of maintaining or improving the health or 
overall function of that chronically ill enrollee. Medicare Advantage 
plans may consider social determinants of health as a factor to help 
identify chronically ill enrollees whose health or overall function 
could be improved or maintained with SSBCI. CMS is also testing the 
Medicare Advantage Value-Based Insurance Design model, which allows 
participants to vary supplemental based on chronic condition or 
socioeconomic status or a combination of the two.

    Adequately and appropriately addressing social determinants of 
health will require the efforts of all stakeholders including 
beneficiaries, community groups, and health care providers. The CMS 
Office of Minority Health collaborated with the Health Resources and 
Services Administration Office of Health Equity on an event focused on 
social determinants of health. Participants heard from renowned 
speakers on how social determinants influence health outcomes, such as 
physical and mental health, and major chronic conditions that have high 
prevalence among several racial and ethnic minority groups.

    Question. According to a GAO report published late last year, 
administrative costs associated with implementing work requirements in 
Medicaid cost over $400 million across just five States, and the 
Federal Government covered over 80 percent ($331 million) of those 
administrative costs. By no means is this an efficient use of taxpayer 
dollars. Has the Department of Health and Human Services estimated the 
administrative costs of implementing work requirements across all 
Medicaid programs in the country? If so, what is it? And, what would be 
the Federal Government's share of the cost?

    Answer. Numerous States requested flexibility offered through 
community engagement demonstrations, and HHS supports them in their 
efforts to tailor their Medicaid programs to make them more efficient 
and sustainable for the enrollees who depend on them. While the program 
costs of the demonstration are subject to 1115 demonstration budget 
neutrality requirements, these demonstrations are not aimed at short-
term budget savings. HHS has encouraged States to leverage existing 
infrastructure in place for SNAP and TANF, but--as with any reform--
States will have to make some investments in updating their IT systems 
and training their staff.

    This administration's goal is to support State programs that help 
create a pathway out of poverty and a bridge to self-sufficiency. If an 
able-bodied, working age adult is purposefully remaining unemployed so 
that they can remain eligible for Medicaid, then we need to work 
together to address these perverse incentives and provide these 
individuals with an alternative way to access coverage that does not 
threaten the sustainability of a program that was never intended to 
provide coverage for that population.

    Question. The 2020 Medicare Physician Fee Schedule (PFS) Final Rule 
includes a policy to increase Medicare payments to primary care 
providers while also decreasing payments to providers that bill mostly 
for services. This policy could have a significant effect on patient 
access to health-care providers. What policies has CMS considered to 
ensure patient access to health-care providers such as physical 
therapists that bill mostly or entirely for services?

    Answer. This administration is committed to strengthening Medicare, 
and this requires making changes that will lower costs while ultimately 
improving health outcomes for beneficiaries. We know it is critical 
that beneficiaries have access to the services they need, and HHS is 
dedicated to ensuring our policies promote this goal. The 2020 Medicare 
Physician Fee Schedule was finalized after undergoing the standard 
rulemaking process, which includes an extensive period for the public 
to provide comments.\7\ HHS greatly relies upon the input we receive 
from the health-care community as we make final policy decisions, and 
we look forward to continuing our work to improve the program while 
ensuring beneficiaries have access to the care they need, including 
services provided by clinicians such as physical therapists.
---------------------------------------------------------------------------
    \7\ Final Rule available at: https://www.federalregister.gov/
documents/2019/11/15/2019-24086/medicare-program-cy-2020-revisions-to-
payment-policies-under-the-physician-fee-schedule-and-other.

    The 2020 Physician Fee Schedule (PFS) final rule adjusted the 
relative value units (RVUs) for office and outpatient evaluation and 
management (E/M) visit codes effective beginning in 2021. The 
Department finalized the proposal to establish values based on 
recommendations by the American Medical Association Specialty Society 
Relative Value Scale Update Committee (RUC), which were based upon a 
survey of more than 50 specialty societies. We generally believe that 
the RUC-
recommended values for these codes accurately reflect the resources 
involved in furnishing office and outpatient E/M visits and used them, 
---------------------------------------------------------------------------
with minor modifications, to establish values for these E/M visits.

    The Department received public comments on the 2020 PFS proposed 
rule in support of revaluing certain services relative to the new 
office/outpatient E/M visit values. In the 2021 PFS proposed rule, we 
are proposing to revalue the following services that include, rely upon 
or are analogous to the office/outpatient E/M visits commensurate with 
the increases in values finalized for office/outpatient E/M visits 
beginning in 2021: end stage renal disease monthly capitation payment 
services, transitional care management services, maternity packages, 
cognitive impairment assessment and care planning, the initial 
preventive physical examination and initial and subsequent annual 
wellness visits, emergency department visits, therapy evaluations 
(including services furnished by physical therapists, occupational 
therapists, and speech language pathologists), and psychiatric 
diagnostic evaluations and psychotherapy services. The proposed 
adjustments help to ensure that CMS is appropriately recognizing the 
kind of care where clinicians need to spend more face-to-face time with 
patients, like primary care and complex or chronic disease management. 
We are currently reviewing public comments on these proposals.

    Question. How will patients benefit from the administration's 
recent proposal in the annual Notice of Benefit and Payment Parameters 
Rule for 2021 to allow insurers to redirect manufacturer coupons from 
patients to the plan, particularly in instances when there are no 
generic or alternative medications available for that patient's 
condition?

    Answer. The Patient Protection and Affordable Care Act places an 
annual limit on the amount of cost sharing that can be incurred by an 
individual enrolled in a non-grandfathered health insurance plan or 
group health plan. In May 2020, CMS finalized a policy in the final 
Notice of Benefit and Payment Parameters Rule for 2021 that allows 
issuers to decide whether direct support given to enrollees by drug 
manufacturers--including through coupons--accrues toward an enrollee's 
annual limitation on cost sharing.\8\ The direct support provided by 
drug manufacturers reduces the amount that the enrollee is required to 
pay in order to obtain coverage for the drug. Under the policy, issuers 
have the flexibility to determine that the value of the coupon would 
not be considered a cost incurred by the enrollee, and will therefore 
not be required to be applied toward the annual limitation on cost 
sharing.
---------------------------------------------------------------------------
    \8\ Patient Protection and Affordable Care Act; HHS Notice of 
Benefit and Payment Parameters for 2021; Notice Requirement for Non-
Federal Governmental Plans, available at: https://
www.federalregister.gov/documents/2020/05/14/2020-10045/patient-
protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-
parameters-for-2021.

    HHS recognizes that copayment support may help enrollees in the 
short term by encouraging adherence to existing medication regimens, 
particularly when copayments may be unaffordable to many patients; 
however, the availability of a coupon or other direct support may cause 
physicians and enrollees to choose an expensive drug when a less 
---------------------------------------------------------------------------
expensive and equally effective alternative drug is available.

    The flexibility afforded under this policy gives plans and issuers 
the ability to address the cost of specific prescription drugs and 
lower the cost of health insurance overall. This final rule ensures 
that issuers and group health plans need not make changes to how they 
have historically handled direct drug manufacturer support amounts. HHS 
does not expect any significant increases in patient costs or non-
adherence to medications if issuers choose to continue their current 
behavior.

                                 ______
                                 
             Questions Submitted by Hon. Benjamin L. Cardin
                            nih budget cuts
    Question. Sufficiently funding the National Institutes of Health is 
one area where Congress has consistently reached bipartisan agreement. 
Robust funding is essential because of the scientific breakthroughs 
that NIH's exceptional American researchers have managed to create over 
the years.

    The President's FY 2021 budget request proposes devastating 
effects: slashing $30 million from minority health research, $190 
million from diabetes and kidney disease research, and $31 million from 
Drug Abuse programs--despite acknowledgement of the opioid crisis 
facing America and the increase in alcohol-related deaths in our 
country.

    The budget proposes to cut $440 million from biomedical research at 
the National Institute of Allergy and Infectious Diseases, which has 
been leading the research into potential new treatments and vaccines to 
address the novel coronavirus outbreak. The budget seems to miss the 
fact that it is impossible to cut funding for basic research and still 
make the kind of strides that our research community is known for.

    Secretary Azar, what was the reasoning behind cutting a significant 
amount of funding to the National Institute of Allergy and Infectious 
Diseases, which is tasked with combating deadly infectious diseases 
like the novel coronavirus?

    Answer. The budget continues to support biomedical research within 
NIH. Following the release of the President's budget, the NIH budget 
was amended to fund NIAID at a level that would be flat with the FY 
2020 enacted level and surpassing the FY 2021 budget over $400 million. 
Within this total for NIAID, the budget would maintain the FY 2020 
enacted level for NIAID's universal influenza vaccine research. These 
activities include innovative research regarding investigational 
products for the diagnosis, treatment, and prevention of influenza 
infection, and to protect against future pandemics. This research 
informs new and improved therapies, diagnostics, and vaccines which is 
conducted through NIAID.

    In addition, the administration's budget invests nearly $1 billion 
in influenza detection and surveillance, prevention research, and 
collaboration efforts across HHS to enhance pandemic preparedness. This 
large investment accounts for supporting activities across HHS, which 
includes ASPR modernizing influenza vaccine manufacturing 
infrastructure and advance medical countermeasure research and 
development, supporting CDC's Influenza Program which will expand 
influenza vaccine effectiveness monitoring systems and develop and 
characterize candidate vaccine viruses for vaccine manufacturers, and 
efforts to improve the evidence-base on non-egg-based vaccine, and for 
FDA to support regulatory science research and clinical assessments to 
promote development and access to safe and effective influenza 
vaccines.

    Question. Why does the budget not reflect additional funding for 
NIH, CDC, and other HHS agencies to address the novel coronavirus?

    Answer. The budget continues to support a wide range of 
preparedness and response activities across NIH, CDC, ASPR, and other 
HHS agencies. The President's budget was formulated in advance of the 
full scale COVID pandemic. The budget continued to propose funding for 
the Infectious Diseases Rapid Response Reserve Fund at CDC, which 
provided resources to fund critical and urgent activities at the 
earliest stages of the COVID outbreak. The scale and magnitude of the 
COVID response was closely monitored and lead to various COVID 
supplemental appropriations that provided significant funding to 
address the outbreak.

    Question. How did the President determine which of these NIH 
programs merited such drastic decreases in funding? Was any medical 
researcher, scientist, or NIH personnel consulted in making these 
decisions?

    Answer. The FY 2021 President's budget reflects the 
administration's commitments to advance a patient-centered health care 
system, protect the American people from public health threats, promote 
independence, and streamline Federal programs. NIH is constantly 
engaged with the budget formulation.
                 esrd medicare advantage proposed rule
    Question. Medicare Advantage is known to support very ill patients 
through care coordination and supplemental benefits not found in 
Medicare. As you know, individuals with ESRD have historically been 
unable to enroll in Medicare Advantage (MA) plans. In 2016, I led the 
effort to allow ESRD patients to have access to MA plans beginning in 
2021 and was thrilled that it passed as part of the 21st Century Cures 
Act.

    The Department of Health and Human Services released a proposed 
rule to implement this policy, though many patient groups and others in 
the kidney care community have raised concerns. For example, 
stakeholders have raised concerns that MA plans taking on high cost 
ESRD beneficiaries may increase costs, reduce supplemental benefits, or 
limit service areas--not just for ESRD patients, but for all MA 
enrollees. Weakening network adequacy requirements could allow insurers 
to structure plans that do not provide adequate providers and services 
for these ESRD and chronic kidney patients.

    Can you describe how the administration plans to ensure dialysis 
patients have a meaningful and real choice when selecting MA plans?

    Answer. The FY 2021 budget continues to implement the President's 
executive order on Protecting and Improving Medicare for Our Nation's 
Seniors, building on those aspects of the program that work well, while 
also introducing market-based approaches to Medicare reimbursement. The 
administration seeks to protect and reform Medicare with proposals that 
strengthen fiscal sustainability and deliver value to patients. To 
drive reform, the Centers for Medicare and Medicaid Services (CMS) is 
modernizing the Medicare Advantage program and expanding flexibility 
for Medicare Advantage plans to maximize choices for seniors. In CY 
2021, CMS data confirm 99 percent of Medicare beneficiaries had access 
to at least one Medicare Advantage plan in CY 2020, and there were an 
average 39 plan options in each county, an 18 percent increase from 33 
average plan options available in 2019.

    Through policies included in the Contract Year 2021 Policy and 
Technical Changes to the Medicare Advantage Program, Medicare 
Prescription Drug Benefit Program, and Medicare Cost Plan Program final 
rule issued in June 2020, CMS strengthened network adequacy rules for 
Medicare Advantage plans. The rule codified our existing network 
adequacy methodology and finalized new policies to provide support for 
more plan options in rural areas and encourage the use of telehealth in 
all areas. In rural areas, CMS reduced the required percentage of 
beneficiaries that must reside within the maximum time and distance 
standards from 90 percent to 85 percent. This may expand Medicare 
Advantage plan options for beneficiaries by helping Medicare Advantage 
organizations to build networks in these areas. To encourage and 
account for telehealth providers in contracted networks, we provided 
Medicare Advantage plans a 10-percent credit towards the percentage of 
beneficiaries that must reside within required time and distance 
standards when the plan contracts with telehealth providers for 
Dermatology, Psychiatry, Cardiology, Otolaryngology, Neurology, 
Ophthalmology, Allergy and Immunology, Nephrology, Primary Care, 
Gynecology/OB/GYN, Endocrinology, and Infectious Diseases. To take into 
account the adverse effects that Certificate of Need (CON) laws have on 
access, we codified that Medicare Advantage organizations may receive a 
10-percent credit towards the percentage of beneficiaries residing 
within published time and distance standards for affected provider and 
facility types in States that have CON laws, or other State imposed 
anticompetitive restrictions, that limit the number of providers or 
facilities in a county or State. To recognize greater competition and 
greater use of other dialysis treatment modalities in different 
communities, CMS provided for a more flexible approach to meeting 
network adequacy standards for Outpatient Dialysis than the current 
rigid time and distance requirements.

    Beneficiary choice is important and beneficiaries with ESRD--like 
all other beneficiaries--should carefully consider their enrollment 
options when they become eligible for Medicare and during subsequent 
annual election periods. All beneficiaries who join a Medicare 
Advantage plan have opportunities to change plans or return to the 
original Medicare fee-for-service program during the annual election 
period (October 15th through December 7th) or the Medicare Advantage 
Open Enrollment Period (January 1st through March 31st for 
beneficiaries enrolled as of January 1st, and during the first 3 months 
of Medicare Part A entitlement and Part B enrollment for newly eligible 
beneficiaries). In some cases, such as when a beneficiary moves out of 
the service area or is in a plan that does not renew its contract, a 
special election period is available. Beneficiaries may also use 
special election periods for exceptional conditions,\9\ as appropriate, 
including the special election period for individuals with ESRD whose 
entitlement determination was made retroactively to enroll in an MA 
plan. Further, to the extent that there is an exceptional situation for 
an individual that is not addressed by our existing special election 
periods, we will have the ability to respond to the exceptional 
situation.\10\ Finally, there are special election periods available in 
situations where the MA plan fails to provide medically necessary 
services or the plan (or its agents) materially misrepresented the 
plan's provisions in marketing materials.
---------------------------------------------------------------------------
    \9\ Newly codified in Sec. 422.62(b)(4) through (25) and described 
in section 30.4.4 of Chapter 2, Medicare Managed Care Manual.
    \10\ Pursuant to Sec. 422.62(b)(26)
---------------------------------------------------------------------------
                     oral health training programs
    Question. In 2000, then-Surgeon General David Satcher reminded the 
Nation that oral health is essential to general human health. Since 
2000, we have made some huge strides in ensuring access to affordable 
dental care. Medicaid and CHIP have come together to provide dental 
benefits to 43 million children from economically vulnerable families. 
These kids are the most likely to have tooth decay, but now they are 
able to have the dental check-ups to help stop minor oral health issues 
from becoming something life altering.

    Key to the success of this program is having sufficient dentists in 
all communities across America. Unfortunately, 51 million Americans 
currently live in a designated dental health professional shortage area 
according to the Health Resources and Services Administration (HRSA).

    HRSA's Oral Health Training programs have trained thousands of 
primary care dental residents and oral health-care providers, many of 
whom choose to stay working in underserved communities. The President's 
budget proposes to cut the entire $41 million budget of these Oral 
Health Training Programs for 2020. While the FY 2021 budget makes a 
commitment to the National Health Service Corps, which provides 
scholarships and loan repayment to improve primary care, dental, and 
behavioral health in rural and underserved areas, it does not provide 
additional funding.

    If the Oral Health Training program was eliminated, do you believe 
we would still be able to attract oral health-care providers to these 
rural and underserved communities?

    Answer. The Oral Health Training Programs seeks to increase access 
to high-quality dental health services in rural and other underserved 
communities by increasing the number of oral health-care providers 
working in underserved areas and improving training programs for these 
providers. The FY 2021 President's budget prioritizes funding for 
health workforce activities that provide scholarships and loan 
repayment to eligible clinicians, including dentists and dental 
hygienists, in exchange for their service in areas of the United States 
where there is a shortage of health professionals.

                                 ______
                                 
               Questions Submitted by Hon. Sherrod Brown 
                     and Hon. Robert P. Casey, Jr.
                                 chgme
    Question. The budget proposes to merge several existing graduate 
medical education programs into a single capped grant program--
combining Medicare, Medicaid, and the Children's Hospital Graduate 
Medical Education program (CHGME), while cutting overall funding for 
GME at the same time. Pennsylvania and Ohio have nine children's 
hospitals with CHGME programs. We are concerned that a ``one size fits 
all'' program will not serve the unique needs of children. The health-
care needs of children are different than those of adults and the 
training needed to produce the pediatricians and other providers who 
provide that care are also different. CHGME is dedicated to supporting 
this training. In particular, CHGME plays a huge role in supporting the 
very specialized training that only occurs in many of our children's 
hospitals.

    We face national shortages of pediatric specialists and regional 
shortages of primary care pediatricians; going forward, how will HHS 
ensure that the needs of children will be met?

    Answer. Current graduate medical education funding is outdated, 
overly broad, and not sustainable long-term due to its fragmented 
nature across multiple funding streams and lack of transparency and 
accountability. Effective in FY 2021, this proposal would consolidate 
Federal graduate medical education spending from Medicare, Medicaid, 
and the Children's Hospital Graduate Medical Education Program into a 
single grant program for teaching hospitals. Total funds available for 
distribution in FY 2021 would equal the sum of Medicare and Medicaid's 
2017 payments for graduate medical education, plus 2017 spending on 
Children's Hospital Graduate Medical Education, adjusted for inflation. 
This amount would then grow at the CPI-U minus one percentage point 
each year. Payments would be distributed to hospitals based on the 
number of residents at a hospital (up to its existing cap) and the 
portion of the hospital's inpatient days accounted for by Medicare and 
Medicaid patients. The new grant program would be jointly operated by 
the Administrators of CMS and the Health Resources and Services 
Administration.

    This grant program would be funded out of the general fund of the 
Treasury. The Secretary would have authority to modify the amounts 
distributed based on the proportion of residents training in priority 
specialties or programs (e.g., primary care, geriatrics) and based on 
other criteria identified by the Secretary, including addressing 
health-care professional shortages and educational priorities. These 
changes would modernize graduate medical education funding, making it 
better targeted, transparent, accountable, and more sustainable.
                      social services block grant
    Question. The Social Services Block Grant (SSBG) has been a 
significant and important funding source for child welfare services. In 
Ohio, counties use SSBG to fill gaps in funding including child 
protection, adoption services, foster care and services to prevent 
child abuse. While communities grapple with the long-term impact of the 
opioid crisis, they face high rates of child maltreatment, foster care 
admissions, and child poverty. SSBG remains a critical resource for 
children and families, yet again the President's budget calls for the 
elimination of the $1.7 billion provided to States in the Social 
Services Block Grant.

    Child safety and well-being depends on significant investments in 
both child care and child protection. We do not make children safer by 
slashing funds from one program to boost another.

    Could you explain the rationale behind the elimination of SSBG to 
help offset an increase in the child care entitlement to States?

    Answer. Quality and affordable child care is important for both the 
health of the economy as well as the well-being of our Nation's 
children. We know the need for quality child care options is greater 
than the current supply and this budget reflects our commitment to 
working with States to increase the amount of affordable child care and 
ensure that children are cared for in safe settings that support their 
development.

    This budget proposes to maintain large increases to the Child Care 
and Development Block Grant (CCDBG) that were included in the FY 2019 
and FY 2020 appropriations. States are using these funds to increase 
supply, improve payment rates, and meet other new requirements of the 
Child Care and Development Fund (CCDF) program. Maintaining this 
increase will ensure that States can continue making key changes to 
improve their CCDF programs.

    This budget proposal also includes a significant increase to Child 
Care Entitlement (CCE), which, when combined with CCDBG funding, is 
estimated to serve approximately 1.8 million children and continue the 
progress made since reauthorization to improve the supply and quality 
of care and provide transparent information to both providers and 
parents. The CCE increase offsets changes made in other parts of the 
budget, including the Social Services Block Grant funding elimination 
and TANF program changes, to maintain investments in child care.

    There is also a proposed one-time investment of $1 billion in CCE 
funding for a competitive fund aimed at building the supply of care for 
underserved populations and to stimulate employer investment in child 
care. The funding, available for obligation for 5 years, will be 
awarded to States with the goal of building the supply of care by 
helping certain categories/types of providers enter and stay in the 
market. This would include home-based providers, providers serving 
student parents, and providers offering care during non-traditional 
hours.

    HHS is committed to helping low-income working families meet their 
child care needs, and this budget reflects this priority by supporting 
the tremendous work that States are already doing while also moving the 
field forward by increasing supply to better meet the needs of working 
parents and their children.

    Question. Have you or your office assessed how SSBG's elimination 
would impact children in Ohio and across the country, especially those 
in the child welfare system?

    Answer. The Social Service Block Grant (SSBG) provides funding that 
is duplicative of resources available through other Federal programs. 
In a 2011 Government Accountability Office duplicative program report, 
SSBG was identified as a duplicative program. In addition, the program 
has not demonstrated its effectiveness at achieving the main purposes 
of the program, which include reducing or eliminative dependency on 
public benefits and supporting self-sufficiency.

    The President's FY 2020 budget for the Administration for Children 
and Families (ACF) focuses on facilitating participation in American 
society through promoting work, shifting resources to prevention in 
child welfare, and maintaining support for early childhood education 
and care. The proposal to not include funding for SSBG is the same as 
the FY 2019 President's budget. However, the underlying authorization 
under title XX of the Social Security Act would remain to allow SSBG to 
be funded as a mechanism for rapid response in case of disasters and to 
receive Temporary Assistance for Needy Families transfer funding.

    According to a 2017 Congressional Research Service report entitled, 
Child Welfare: An Overview of Federal Programs and Their Current 
Funding, Federal child welfare support is provided via multiple 
programs, the largest of which are included in the Social Security Act. 
Title IV-B of the Social Security Act primarily authorizes funding to 
States, territories, and tribes to support their provision of a broad 
range of child welfare-related services to children and their families. 
Funding for child welfare programs are primarily administered by ACF's 
Children's Bureau. In addition, there are competitive grant programs 
(authorized by the Victims of Child Abuse Act) administered by the 
Office of Justice Programs within the Department of Justice.
                        tobacco and e-cigarettes
    Question. While I appreciate your stated shared goal of preventing 
a new generation of children from becoming addicted to nicotine through 
e-cigarettes and your responses to my questions during the budget 
hearing on February 13, 2020, I remain frustrated by the lack of 
leadership from this administration on addressing youth tobacco and e-
cigarette use.

    The administration's final policy, issued in January 2020, has left 
thousands of flavored e-cigarette products on the market in vape shops, 
convenience stores, and gas stations across the country. According to 
the Campaign for Tobacco Free Kids, more than 100,000 locations across 
the country continue to sell flavored disposable e-cigarettes, e-
liquids, and refillable devices.

    What specifics is the administration taking to eliminate all 
flavored e-cig products, including disposable e-cigarette and vape 
products, from the market?

    Answer. Protecting our Nation's youth from the dangers of tobacco 
products is among FDA's most important responsibilities, and HHS and 
the agency will continue to take aggressive steps to make sure tobacco 
products are not being marketed or sold to kids. Ensuring that tobacco 
products are not marketed, sold to, or used by youth and educating 
youth on the dangers of tobacco is a cornerstone of our comprehensive 
approach for the regulation of tobacco and are also the focus of FDA's 
Youth Tobacco Prevention Plan, which demonstrates the agency's 
commitment to protecting our children.

    On September 9, 2020, the FDA and the Centers for Disease Control 
and Prevention released new data from the 2020 National Youth Tobacco 
Survey (NYTS),\11\ which show 1.8 million fewer U.S. youth are 
currently using e-cigarettes compared to 2019. After 2 years of 
disturbing increases in youth e-cigarette use, HHS is encouraged by the 
overall significant decline reported in 2020. This is good news; 
however, the FDA remains very concerned about the 3.6 million U.S. 
youth who currently use e-cigarettes and we acknowledge there is work 
that still needs to be done to curb youth use.
---------------------------------------------------------------------------
    \11\ https://www.cdc.gov/mmwr/volumes/69/wr/
mm6937e1.htm?s_cid=mm6937e1_w.

    As stated in your question, in January 2020, FDA issued a guidance 
(``the January 2020 guidance'') outlining the agency's enforcement 
priorities for Electronic Nicotine Delivery Systems (ENDS) products 
that lack marketing authorization (subsequently revised in April 2020). 
[1] Beginning February 6, 2020, FDA began to prioritize enforcement 
against the following groups of illegally marketed ENDS products that 
do not have premarket authorization: any flavored, cartridge-based ENDS 
product (other than a tobacco- or menthol-flavored product); all other 
ENDS products for which the manufacturer has failed to take (or is 
failing to take) adequate measures to prevent minors' access; and any 
ENDS product that is targeted to minors or whose marketing is likely to 
---------------------------------------------------------------------------
promote use of ENDS by minors.

    FDA is actively investigating the illegal sale of these groups of 
products, and hundreds of warning letters have already been issued to 
violative entities. In addition, FDA is now prioritizing enforcement 
for any ENDS product that is offered for sale in the United States, and 
for which the manufacturer has not submitted a premarket application by 
the court-ordered September 9, 2020 deadline (or after a negative 
action by FDA on a timely submitted application).

    The September 9, 2020 deadline for submission of premarket 
applications for deemed, new tobacco products on the market as of 
August 8, 2016, was a milestone to ensure these products undergo a 
robust scientific evaluation by FDA. Scientific review of new products 
is a critical part of how FDA carries out its mission to protect public 
health from the harms associated with tobacco use.

    FDA's compliance and enforcement efforts include: conducting 
establishment inspections and online investigations to determine 
whether firms are continuing to distribute or sell deemed new tobacco 
products without premarket authorization; conducting compliance check 
inspections of retailers to ensure they are complying with the law, 
including not selling unauthorized tobacco products; checking online 
retailers; and performing other types of surveillance, including 
surveillance of imported products, to enforce the premarket 
authorization requirements informed by the agency's enforcement 
priorities. Please note that some of these activities have been 
temporarily postponed due to COVID-19, but they will resume when 
possible, guided by health and safety considerations.

    Generally, where FDA observes violations of the premarket 
requirements, the agency initially issues a warning letter. If 
companies fail to take corrective measures after receiving a warning 
letter, the Center for Tobacco Products (CTP) may pursue enforcement 
actions including civil money penalties, injunctions, no tobacco sale 
orders, or seizures.

    The agency is committed to addressing the public health crisis of 
youth e-cigarette use by, among other things, focusing product review 
and enforcement on youth-
appealing products and investing in campaigns to educate youth \12\ 
about the dangers of e-cigarette use. FDA will remain vigilant in 
monitoring the marketplace, expanding our public education efforts and 
using our regulatory authority--changing course as necessary--to 
further ensure all tobacco products, and e-cigarettes in particular, 
are not marketed to, sold to, or used by kids.
---------------------------------------------------------------------------
    \12\ https://www.fda.gov/tobacco-products/public-health-education/
real-cost-campaign#1.

    In line with FDA's enforcement priorities stated in the January 
2020 guidance, on September 9, 2020, FDA issued warning letters \13\ 
notifying three companies who sell or distribute unauthorized ENDS 
products that their products are illegally marketed. FDA issued a 
warning letter to XL Vape, LLC (doing business as Stig Inc.), a popular 
disposable e-cigarette brand among youth, warning the company to remove 
their disposable e-cigarettes from the market because they do not have 
the required premarket authorization. Additional warning letters were 
issued to Flavour Warehouse LTD (doing business as Vampire Vape) and 
Pretty Women UK LTD (T/A Coil2oil and Mad Kingdom Liquids) for 
illegally marketing unauthorized menthol-flavored e-liquids. The 
labeling and/or advertising of these products also features cartoon 
images, such as vampires and kings, that are commonly marketed and/or 
appeal to youth.
---------------------------------------------------------------------------
    \13\ https://www.fda.gov/inspections-compliance-enforcement-and-
criminal-investigations/compliance-actions-and-activities/warning-
letters.

    These warning letters are just the latest in the series of actions 
FDA has taken in the past weeks and months to ensure that youth do not 
begin using any tobacco product. In late July, the agency issued 
warning letters \14\ to 10 companies, including Puff Bar, warning the 
companies that their products are illegally marketed because they lack 
the required premarket authorization. The agency is working to ensure 
these illegally marketed products are no longer sold, and that the 
products will not be reintroduced on the market until the companies 
have applied for and received marketing authorization from FDA.
---------------------------------------------------------------------------
    \14\ https://www.fda.gov/news-events/press-announcements/fda-
notifies-companies-including-puff-bar-remove-flavored-disposable-e-
cigarettes-and-youth.

    HHS and FDA remain fully committed to protecting the public health 
of America's youth as demonstrated through the agency's efforts in 
compliance and enforcement, public education, regulatory science 
---------------------------------------------------------------------------
research, premarket review, and regulatory policy.

    [1] Final Guidance for Industry: Enforcement Priorities for 
Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products 
on the Market Without Premarket Authorization (revised), available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/enforcement-priorities-electronic-nicotine-delivery-system-
ends-and-other-deemed-products-market.

                                 ______
                                 
               Questions Submitted by Hon. Sherrod Brown
      national institute of occupational safety and health (niosh)
    Question. You have spoken before about how you believe the Centers 
for Disease Control and Prevention (CDC) is the envy of the world when 
it comes to public health. As you know, the CDC is currently working to 
update and replace two NIOSH facilities in Cincinnati, OH. The agency 
is currently undergoing site acquisition activities and, according to a 
meeting Senator Portman and I participated in with representatives from 
the CDC and General Services Administration (GSA) at the end of 2019, 
CDC is on track to award a contract for design services for the project 
this spring.

    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.

    Will you renew your commit to working with Senator Portman and me 
to keep this project moving forward under your leadership at HHS?

    Answer. CDC's National Institute for Occupational Safety and Health 
remains committed to construction and development of the Consolidated 
Cincinnati Research Facility. In August of 2020, the contract for the 
architectural and engineering design of the campus facilities was 
awarded. The facility will consist of 235,000 gross square feet (GSF) 
for office and laboratory building(s), surface parking lots for 
employees, a parking deck for visitors and employees, security 
infrastructure, landscaping, and other additional work at the new CDC/
NIOSH campus site. CDC expects the design phase to be complete in fall 
2021, with construction beginning in early 2022 and completion in 2024. 
As the project continues to accelerate, we are committed to working 
with you and Senator Portman to keep this project moving forward.
                         physician fee schedule
    Question. My office has received a number of meeting requests and 
comments from Ohio constituents regarding the 2020 Physician Fee 
Schedule Final Rule and proposals that may be included in the 2021 
Physician Fee Schedule Proposed Rule (yet to come out). While each 
stakeholder organization has its own priorities, many of them are 
frustrated by the Centers for Medicare and Medicaid (CMS) approach to 
gathering information and engaging with stakeholders throughout the 
rulemaking process.

    What will you do to ensure CMS provides stakeholders with 
sufficient opportunity to engage on proposals related to the 2021 
Physician Fee Schedule rule leading up to the CMS proposed rule and 
then, once proposed, during both the official comment period?

    What steps are you planning to take to ensure sufficient 
information and data is gathered to inform future policy changes?

    Answer. This administration is committed to working closely with a 
variety of stakeholders, including providers on the front lines of 
care, to ensure our policies are improving the health-care system. The 
Department follows standard rulemaking procedure, which includes an 
extensive comment period for public feedback, and engages in numerous 
efforts to obtain stakeholder input. This can include regular calls 
with States, provider, patient advocacy organizations, industry groups, 
and other experts to discuss potential changes and to explain new 
policy decisions. The best innovation comes from the front lines, and 
this administration relies greatly on the feedback we receive to inform 
our work.

    Each year CMS develops adjustments to the relative value units 
under the Physician Fee Schedule (PFS) based on our review of 
information that generally includes, but is not limited to, 
recommendations received from the American Medical Association/
Specialty Society Relative Value Scale Update Committee (RUC), the 
Health Care Professionals Advisory Committee , the Medicare Payment 
Advisory Commission, and other public commenters; medical literature 
and comparative databases; as well as a comparison of the work for 
other codes within the Medicare PFS, and consultation with other 
physicians and health care professionals within CMS and the Federal 
Government. We also assess the methodology and data used to develop the 
recommendations submitted to us by the RUC and other public commenters, 
and the rationale for their recommendations.

    CMS proposes to establish relative value units for each calendar 
year for the PFS to ensure that our payment systems are updated to 
reflect changes in medical practice and the relative value of services, 
as well as changes in the statute. CMS accepts comments from the public 
for 60 days following the publication of the proposed rule, which are 
used to inform our final policies. Following the publication of final 
rules for the PFS, we encourage stakeholders to submit information such 
as invoices or other information to improve the accuracy of pricing to 
CMS by February 10th of the following year for consideration in future 
rulemaking, similar our process for consideration of RUC 
recommendations. We also continue to engage with stakeholders outside 
of rulemaking to receive feedback to inform future policies.
                                  mfar
    Question. The recently proposed Medicaid Fiscal Accountability 
Regulation (MFAR) contains several provisions that would significantly 
impact the financing of Ohio's Medicaid program. If finalized, the rule 
would have a chilling effect on Ohio's program--potentially impacting 
enrollees and services offered.

    What plans does CMS have to engage in additional impact analysis 
related to the proposed rule?

    What engagement has CMS had with States that would be impacted by 
the proposed rule?

    Answer. The Medicaid Fiscal Accountability Regulation (MFAR), CMS-
2393-P, was published in the November 18, 2019, issue of the Federal 
Register, with a 60-day comment period that closed on January 17, 2020, 
which was subsequently extended by 15 days and closed on February 1, 
2020. During this time, CMS also conducted numerous calls with States 
and other stakeholders to receive substantive feedback to help us 
understand the potential impact of the proposed rule.

    The policies proposed within the rule are intended to ensure 
accountability of State financing, transparency of payments, and the 
fiscal integrity of the Medicaid program, including through numerous 
clarifications to Medicaid financing and oversight rules. However, 
please know that we have listened closely to concerns that have been 
raised by our State and provider partners about potential unintended 
consequences of the proposed rule, which require further study. 
Therefore, CMS has withdrawn the rule from the regulatory agenda.
                           maternal mortality
    Question. Each year, an estimated 700 women in the U.S. lose their 
lives due to pregnancy-related complications, with African American 
mothers dying at 2-4 times the rate of white mothers. Data from the 
Centers for Disease Control and Prevention (CDC) shows that more than 
60 percent of pregnancy-related deaths occur in the days between 
delivery and one year postpartum and research demonstrates that up to 
half of all maternal deaths may be preventable. Because Medicaid is our 
Nation's primary source of insurance for expecting moms and childbirth, 
experts agree that extending Medicaid coverage for new moms for a full 
year postpartum will help improve health outcomes for both moms and 
babies.

    The President's budget includes a proposal to extend Medicaid 
coverage for postpartum women with a substance use disorder for up to a 
full year after the birth of a baby. What more is your Department doing 
to help strengthen coverage and access to high-quality, comprehensive 
care for all mothers through Medicaid?

    Answer. As the single largest payer for maternity care in the 
United States, Medicaid plays an important role in perinatal and 
maternal health. In 2014, CMS launched its Maternal and Infant Health 
Initiative (MIHI) to explore program and policy opportunities to 
improve outcomes and reduce the cost of care for women and infants in 
Medicaid and CHIP. Since then, much work has been done, such as the 
Postpartum Care Action Learning Series, a learning collaborative of 
States to drive quality improvement around postpartum care.

    CMS is currently evaluating activities over the past 5 years, which 
includes publishing three issue briefs on March 9, 2020, to describe 
initiatives undertaken in the first phase of MIHI. These issue briefs 
are:

        Lessons Learned About Payment Strategies to Improve Postpartum 
Care in Medicaid and CHIP: This brief outlines the lessons learned 
about payment strategies to improve postpartum care visit rates and 
summarizes the changes three States made related to paying for 
maternity care in order to improve postpartum care under the Postpartum 
Care Action Learning Series.\15\
---------------------------------------------------------------------------
    \15\ Available at: https://www.medicaid.gov/medicaid/quality-of-
care/downloads/postpartum-payment-strategies.pdf.
---------------------------------------------------------------------------
        The Maternal and Infant Health Initiative Grant to Support 
Development and Testing of Medicaid Contraceptive Care Measures: The 
CMS MIHI grant program supported development and testing of Medicaid 
contraceptive care measures. This analytic brief discusses the MIHI 
grant program, describes the contraceptive care measures developed as 
part of this effort, summarizes data reported by the MIHI grantees, 
highlights uses of the data, and identifies lessons learned.\16\
---------------------------------------------------------------------------
    \16\ Available at: https://www.medicaid.gov/medicaid/quality-of-
care/downloads/mihi-contraceptive-measures.pdf.
---------------------------------------------------------------------------
        Improving Postpartum Care: State Projects Conducted through 
the Postpartum Care Action Learning Series and Adult Medicaid Quality 
Grant Program: This issue brief describes the quality improvement teams 
in the 10 States, their aims, the interventions they tested, their 
results, and lessons learned. In addition, this fact sheet provides 
summaries of the postpartum care-related projects that four States 
undertook as Adult Medicaid Quality grantees.\17\
---------------------------------------------------------------------------
    \17\ Available at: https://www.medicaid.gov/medicaid/quality-of-
care/downloads/postpartum-als-state-projects.pdf.

    In 2018, CMS announced the Maternal Opioid Misuse (MOM) model, 
which addresses the need to better align and coordinate care of 
pregnant and postpartum Medicaid beneficiaries with opioid use disorder 
(OUD) through State-driven transformation of the delivery system 
surrounding this vulnerable population. By supporting the coordination 
of clinical care and the integration of other services critical for 
health, well-being, and recovery, the MOM model has the potential to 
improve quality of care and reduce expenditures for mothers and 
infants. In December 2019, CMS announced the following 10 States were 
awarded MOM Model funding: Colorado, Indiana, Louisiana, Maine, 
---------------------------------------------------------------------------
Maryland, Missouri, New Hampshire, Tennessee, Texas, and West Virginia.

    Additionally, CMS is reconvening an expert workgroup to help chart 
a course for the future of maternal infant health quality measurement 
and improvement. The workgroup will represent a wide variety of key 
stakeholders and Federal agencies and will provide updated 
recommendations for measurement, quality improvement and technical 
assistance opportunities.

    In Medicaid and CHIP, the measures in the voluntary Child and Adult 
Core Sets assess the quality of care women receive at each step in 
their lifecycle and include quality measures associated with major 
drivers of pregnancy-related mortality and severe maternal morbidity. 
CMS has identified a subset of 11 Child and Adult Core Set measures for 
2020 that comprise a Core Set of Maternal and Perinatal Health Measures 
for Medicaid and CHIP (Maternity Core Set).\18\ The Maternity Core Set 
includes a measure of early elective delivery, along with measures that 
examine prenatal and postpartum care, low birth weight babies and well-
baby care. Since the core sets were established in 2010 and 2012, 
States have made significant progress reporting these measures. With 
the passing of the Bipartisan Budget Act of 2018 (Pub. L. 115-123), 
State reporting of the Child Core Set, including maternal and infant 
health measures, will become mandatory beginning in 2024.
---------------------------------------------------------------------------
    \18\ Available at: https://www.medicaid.gov/medicaid/quality-of-
care/downloads/performance-measurement/2020-maternity-core-set.pdf.

    The Medicaid and CHIP Scorecard is a central component of CMS's 
commitment to increase public transparency and accountability about the 
programs' administration and outcomes.\19\ The Scorecard currently 
includes one maternal health measure (Postpartum Care), as well as two 
other measures from the Maternity Core Set, Well-Child Visits in the 
First 15 Months of Life and Live Births Weighing Less Than 2,500 Grams. 
Over time, the Scorecard will evolve to include health outcome metrics, 
and we are considering how the Scorecard can address maternal and 
infant health. CMS continues to work with States to encourage greater 
reporting to improve consistency across States.
---------------------------------------------------------------------------
    \19\ Available at: https://www.medicaid.gov/state-overviews/
scorecard/index.html.
---------------------------------------------------------------------------
                  maximizing our health-care workforce
    Question. The President's FY 2021 proposed budget includes some 
language around supporting health-care professionals so that they may 
practice at the top of their license.

    Can you please clarify what non-physician health-care professionals 
you plan on including in this effort?

    Answer. The Fiscal Year 2021 Congressional Justification includes a 
description of the National Health Service Corps State Loan Repayment 
Program (SLRP) on pages 82 and 83. Specifically, the description says 
``States receiving funding from SRLP are encouraged to allow health 
professionals to practice to the full extent of their license.'' Apart 
from physicians, the health professional disciplines and specialties 
eligible to participate in SLRP, as referenced in this language 
include:

        Nurse Practitioners (specializing in adult, family, 
pediatrics, psychiatry/
mental health, geriatrics, women's health, and certified nurse-
midwives).
        Physician Assistants (specializing in adult, family, 
pediatrics, psychiatry/
mental health, geriatrics, or women's health).
        Dental professionals (general, pediatric, registered dental 
hygienists).
        Mental health professionals (health service psychologists, 
licensed clinical social workers, psychiatric nurse specialists, 
licensed professional counselors, marriage and family therapists).
        Registered Nurses.
        Pharmacists.
        Substance use disorder counselors (licensed/credentialed/
certified by their state of practice that meet educational requirements 
and master's degree requirement).

                                 ______
                                 
             Questions Submitted by Hon. Michael F. Bennet
    Question. I have been working with Senators Cassidy and Hassan to 
end surprise medical bills at the Federal level. It is outrageous that 
Americans can't easily identify which providers are in their network. 
Even when they do their research, they can still receive financially 
devastating bills, sometimes weeks or months later. Last year, Colorado 
took a strong step forward to protect patients from this predatory 
practice at the State level, but it doesn't protect all patients, so 
it's time for the Federal Government to do the same. The President also 
mentioned this issue in his budget.

    How is the administration directing resources to help address this 
problem and protect patients from surprise medical bills?

    Is the administration committed to our approach that includes an 
automatic payment with an option for providers to go to arbitration but 
only holds patients responsible for their in-network copay?

    Answer. For too long, surprise medical billing has left some 
patients with unexpected and unjustified charges for services they did 
not know were out of network. The Trump administration believes it is 
past time to put an end to these deceptive medical billing practices. 
In May 2019, the administration released its principles on surprise 
billing which are: patients receiving emergency care should not be 
forced to shoulder extra costs billed by a care provider but not 
covered by their insurer; patients receiving scheduled care should have 
information about whether providers are in or out of their network and 
what costs they may face; patients should not receive surprise bills 
from out-of-network providers they did not choose; and Federal health-
care expenditures should not increase.

    Since then, the administration has taken regulatory action that 
will increase price transparency by hospitals and insurers, making 
health care prices more accessible to patients and the general public. 
In addition, the administration used its authority to prohibit 
providers receiving reimbursement for COVID-19 services from the 
Provider Relief Fund from balance billing patients during the current 
public health emergency. This administrative action helps protect 
patients from surprise bills for COVID treatment as well as for non 
COVID-related services. However, the administration currently does not 
have the statutory authority to implement a more permanent and 
comprehensive solution to surprise billing; congressional action is 
needed. This is why the administration has repeatedly called on 
Congress to act to eliminate the burden of surprise medical bills for 
patients across the country. We look forward to continuing to work with 
Congress to end this practice for good and to protect American 
families.

    Question. Suicide is now the leading cause of death for teenagers 
in Colorado, and the State has the 11th worst suicide rate in the 
country. Some of the largest behavioral health providers in our State 
have also closed, which means that many families need to go out of 
State just to receive adequate mental health treatment. This can be due 
to a lack of beds or specialty care available. Medicaid covers about 40 
percent of all children and youth in Colorado and we know that the 
barriers to care for children who live in poverty are even higher.

    How would the budget's nearly $1-trillion cut in Medicaid affect 
mental and behavioral health services for children who receive care 
through the program?

    Although the budget contains some new investments, they amount to 
less than 1.5 percent of the funds we stand to lose if the 
administration repeals Medicaid expansion, a crucial program for 
Coloradans. One particularly troubling story belongs to a mother in 
Colorado and her young daughter, who at 6 years old attempted suicide.

    Will a $1-trillion cut to Medicaid help families and children in 
America like this mother and her daughter?

    Answer. Suicide is the 10th leading cause of death in the United 
States--responsible for more than 47,000 deaths in 2017--and suicide 
rates have increased steadily for individuals of all ages. HHS is 
committed to addressing this major health issue through public health 
surveillance, research, State and community based funding for mental 
health services, and supporting treatment. That's why the FY 2021 
budget proposes $93 million for suicide prevention activities, 
including additional funding to expand Zero Suicide initiatives to 
focus on adult suicide prevention and allow communities and States to 
tailor strategies to prevent suicide in their local jurisdictions. In 
addition, the FY 2021 budget does not propose cutting Medicaid, but 
rather maintains funding to at least FY 2020 levels and slows annual 
growth of the program from 5.4 percent to 3.1 percent.

    The FY 2021 budget will also provide targeted flexibility for 
States to provide inpatient mental health services to Medicaid 
beneficiaries with serious mental illness. Americans with serious 
mental illness face significant challenges getting the care they need. 
In 2018, 47.6 million adults had a mental illness, of whom 11.3 million 
suffered from serious mental illness, meaning their mental illness 
substantially interfered with or limited major life activities. More 
than one out of every three individuals with serious mental illness do 
not receive mental health care, and those who receive care often 
encounter a fragmented mental health system that is difficult to 
navigate.

    Longstanding Federal law has prohibited States from receiving 
Federal matching funds for providing services to Medicaid beneficiaries 
while residing in an institution for mental disease (IMD). In November 
2018, CMS announced a new Medicaid demonstration opportunity for States 
to receive authority to pay for short-term residential treatment 
services in an IMD for adults with serious mental illness and children 
with serious emotional disturbance. These demonstrations are allowing 
States to broaden access to treatment for individuals across the entire 
behavioral health spectrum. The FY 2021 budget includes a proposal that 
would build upon these efforts by allowing States the option of 
receiving Medicaid reimbursement for covered services in institutions 
for mental disease for adults with serious mental illness without a 
waiver, subject to meeting certain criteria.

    Question. I am hearing significant concerns about a potential loss 
of Medicaid access in rural counties of Colorado under the cap on 
supplemental payments that CMS proposed in the Medicaid Fiscal 
Accountability Rule (MFAR).

    Can you quantify the loss in coverage you expect if CMS implements 
this cap as proposed?

    Can you explain how CMS would mitigate this reduction in access?

    Answer. The Medicaid Fiscal Accountability Regulation (MFAR), CMS-
2393-P, was published in the November 18, 2019, issue of the Federal 
Register, with a 60-day comment period that closed on January 17, 2020, 
which was subsequently extended by 15 days and closed on February 1, 
2020. During this time, CMS also conducted numerous calls with States 
and other stakeholders to receive substantive feedback to help us 
understand the potential impact of the proposed rule.

    The policies proposed within the rule are intended to ensure 
accountability of State financing, transparency of payments, and the 
fiscal integrity of the Medicaid program, including through numerous 
clarifications to Medicaid financing and oversight rules. However, 
please know that we have listened closely to concerns that have been 
raised by our State and provider partners about potential unintended 
consequences of the proposed rule, which require further study. 
Therefore, CMS has withdrawn the rule from the regulatory agenda.

    HHS is committed to ensuring State compliance with section 
1902(a)(30)(A) of the Social Security Act, which requires Medicaid 
provider payments to be ``consistent with efficiency, economy, and 
quality of care and are sufficient to enlist enough providers'' to 
provide access to care and services at least to the extent available to 
the general population in the geographic area. We will continue to 
monitor access to care and services for Medicaid beneficiaries, and 
have announced a new comprehensive strategy for monitoring access to 
care in Medicaid on July 11, 2019. That strategy may be accessed here: 
https://www.medicaid.gov/sites/default/files/federal-policy-guidance/
downloads/CIB071119.pdf.

    Question. To justify the 50-percent cap on supplemental payments to 
practitioners in the MFAR, CMS cites concerns about oversight of the 
Average Commercial Rate (ACR).

    Why did CMS choose to propose elimination of the ACR that has been 
used in supplemental payment State Plan Amendments since at least 2005?

    Why didn't CMS instead propose providing better oversight of ACR 
calculations?

    If neither of these explain the 50-percent cap, then how did CMS 
choose the cap on supplemental payments?

    Answer. The Medicaid Fiscal Accountability Regulation (MFAR), CMS-
2393-P, was published in the November 18, 2019, issue of the Federal 
Register, with a 60-day comment period that closed on January 17, 2020, 
which was subsequently extended by 15 days and closed on February 1, 
2020. During this time, CMS also conducted numerous calls with States 
and other stakeholders to receive substantive feedback to help us 
understand the potential impact of the proposed rule.

    The policies proposed within the rule are intended to ensure 
accountability of State financing, transparency of payments, and the 
fiscal integrity of the Medicaid program, including through numerous 
clarifications to Medicaid financing and oversight rules. However, 
please know that we have listened closely to concerns that have been 
raised by our State and provider partners about potential unintended 
consequences of the proposed rule, which require further study. 
Therefore, CMS has withdrawn the rule from the regulatory agenda.

    Question. According to CDC data, overdoses involving opioids killed 
more than 47,000 people in 2017, and 36 percent of those deaths 
involved prescription opioids. Congress passed into law several 
initiatives to treat patients facing opioid addiction but also to 
prevent addiction from occurring in the first place. We are still far 
from ``solving'' the opioid crisis or other addiction crises like meth 
and alcohol, so we need to explore more options while also ensuring the 
initiatives we have passed into law are implemented in a timely manner.

    The SUPPORT for Patients and Communities Act (Pub. L. No: 115-271), 
which Congress passed and the President signed into law in October 
2018, included a broadly bipartisan provision requiring the use of e-
prescribing for all controlled substances under Medicare Part D by 
January 1, 2021, with reasonable exceptions based on similar State 
laws. Half of all States have already required e-prescribing, or will 
soon require it like Colorado, to combat the opioid epidemic.

    We see that several States have already implemented their laws 
without significant interruptions to care. Can you work with CMS 
Administrator Verma to engage with my office to update me in the next 
few weeks on your plan to fully implement e-prescribing for 
prescription opioids, as required by statute, by January 1, 2021?

    Answer. Section 2003 of the SUPPORT Act requires prescriptions for 
controlled substances covered under Medicare Part D to be submitted 
electronically by prescribers, unless a waiver applies, by January 1, 
2021. We recognize the importance of electronic prescribing of 
controlled substances (EPCS) and the statutory mandate. CMS is working 
hard to make sure plans have the resources and support they need to 
implement these new requirements and we encourage all prescribers to 
conduct EPCS as soon as is feasible for them. We understand that 
implementing EPCS takes additional time and resources for prescribers. 
We also recognize that the current public health emergency for the 
COVID-19 pandemic presents additional EPCS challenges for some 
prescribers. As part of the CY 2021 Physician Fee Schedule proposed 
rule (CMS-1734-P) issued on August 3, 2020, we proposed to require all 
prescribers to conduct electronic prescribing of Schedule II, III, IV, 
and V controlled substances under Medicare Part D using the NCPDP 
SCRIPT 2017071 standard by January 1, 2022, except in circumstances in 
which the Secretary waives the requirement. Based on comments received, 
CMS finalized the provision with an effective date of January 1, 2021 
and a compliance date of January 1, 2022 to encourage prescribers to 
implement EPCS as soon as possible, while helping ensure that our 
compliance process is conducted thoughtfully. We believe that this 
phased approach strikes a balance of adhering to the timeframe set 
forth in the SUPPORT Act, supporting more rapid implementation of EPCS, 
and giving prescribers adequate time to comply with the EPCS 
implementation requirement.

    In addition, on July 30, 2020, we issued a Request for Information 
(RFI) soliciting input from stakeholders around implementation of 
Section 2003--in particular, whether CMS should include exceptions to 
the EPCS and under what circumstances, and whether CMS should impose 
penalties for noncompliance with this mandate in its rulemaking, and 
what those penalties should be. The RFI sought input from stakeholders, 
including prescribers that CMS does not directly regulate under MA, 
and/or Part D, and who are not enrolled in Medicare or Medicaid. 
Responses to this RFI were due on October 5, 2020. The SUPPORT Act 
requires that CMS use rulemaking to determine any processes for 
enforcement, including on any prescriber waivers, penalties and 
appeals. CMS will continue to consider comments and recommendations 
received in response to both the proposed rule and the RFI and will 
propose any such processes in a future rule, to be effective no earlier 
than January 1, 2022.

    Question. The growing coronavirus outbreak is a stark reminder of 
the central role infectious disease (ID) physicians play in responding 
to emerging infectious diseases and other public health emergencies. 
Despite the vital contribution ID physicians make to patient care, 
research, and public health, their work continues to be undervalued. 
While 90 percent of ID physicians' care falls under evaluation and 
management (E/M), the current E/M codes do not reflect the increasing 
complexity of E/M work. The current reimbursement is driving fewer 
physicians to enter the field of ID at a time when we need these 
experts to respond to a host of threats including coronavirus. I was 
pleased that CMS significantly modified its payment for E/M services in 
the CY 2020 Medicare Physician Fee Schedule (PFS), but I don't believe 
the modifications address the underlying undervaluation of existing E/M 
services.

    To address this concern, would you be willing to establishing a 
Technical Expert Panel (TEP) at CMS to generate expert stakeholder 
input to refine E/M payment and policies? This could include outlining 
the specifications and objectives for conducting research regarding E/M 
codes.

    Answer. The calendar year (CY) 2020 Physician Fee Schedule (PFS) 
final rule issued on November 1, 2019, adjusted the relative value 
units (RVUs) for office and outpatient evaluation and management (E/M) 
visit codes effective beginning in CY 2021. The Department finalized 
the proposal to establish values based on recommendations by the 
American Medical Association Specialty Society Relative Value Scale 
Update Committee (RUC), which were based upon a survey of more than 50 
specialty societies. We generally believe that the RUC-recommended 
values for these codes accurately reflect the resources involved in 
furnishing office and outpatient E/M visits and used them, with minor 
modifications, to establish values for these E/M visits.

    Although we believe that the RUC-recommended values for the revised 
office/
outpatient E/M visit codes will more accurately reflect the resources 
involved in furnishing a typical office/outpatient E/M visit, we 
continue to believe that the typical visit described by the revised and 
revalued office/outpatient E/M visit code set still does not adequately 
describe or reflect the resources associated with primary care and 
certain types of specialty visits. Therefore, in the CY 2020 PFS final 
rule (84 FR 62856), we finalized the HCPCS add-on code GPC1X which 
describes the ``visit complexity inherent to evaluation and management 
associated with medical care services that serve as the continuing 
focal point for all needed health care services and/or with medical 
care services that are part of ongoing care related to a patient's 
single, serious, or complex condition.'' We stated that we were not 
restricting billing based on specialty, but that we did assume that 
certain specialties, including infectious disease, furnished these 
types of visits more than others.

                                 ______
                                 
            Questions Submitted by Hon. Robert P. Casey, Jr.
                                medicaid
    Question. The NPRM announced on December 20, 2019 entitled 
``Strengthening the Program Integrity of the Medicaid Eligibility 
Determination Process'' (CMS-2421-P) received a ``no'' designation when 
reviewed for economic significance. This is inconsistent with public 
statements by Administrator Verma (e.g., CMS.gov blog, June 25, 2019 
where the director States over $9.63 billion has been recovered through 
oversight efforts in just one State) or your own statements in response 
to my letters. Likewise, the President's budget calls for economically 
significant oversight through program integrity efforts in the amount 
of $34.2 billion in savings over 10 years.

    Explain how the proposals in the Strengthening the Program 
Integrity of the Medicaid Eligibility Determination Process are 
economically insignificant while the opposite is claimed in the FY 2021 
budget, comments from you and comments from Administrator Verma claim 
enormous fiscal cuts to the Medicaid program.

    Answer. HHS has not released the Proposed Rule ``Strengthening the 
Program Integrity of the Medicaid Eligibility Determination Process'' 
(CMS-2421-P). If the Department moves forward with a proposal, we will 
follow standard rulemaking procedure, which includes an extensive 
comment period for public feedback. We welcome input from all of our 
stakeholders as we make important policy decisions to improve our 
programs.
                          pandemic/coronavirus
    Question. The past few weeks have seen a significant increase in 
the threat of COVID-19 worldwide. The threat to the public health of 
Americans is significant, particularly for at-risk populations, like 
people with disabilities and older adults. Epidemics and pandemics are 
unpredictable and we need to be ready to respond quickly and to respond 
on a global level. As COVID-19 has shown, events 8,000 miles away can 
reach us overnight.

    The President's budget proposes to slash significant funds from CDC 
and HHS programs that prepare for and respond to public health 
emergencies such as COVID-19. One example is a proposed almost 20-
percent reduction in the Public Health and Social Services Emergency 
Fund. You have also proposed significant cuts to the CDC programs that 
address public health preparedness and response, including a $85 
million cut to efforts to address emerging infectious disease. You 
propose to reduce the overall CDC budget by over $1.2 billion or over 
18 percent. In a time when preparation and response to unanticipated 
diseases and health emergencies are so important, please detail why you 
have proposed cutting funding to programs that make it possible for the 
United States to prepare for these unexpected events and to respond 
with our global neighbors to the events, as well as how these cuts may 
impact the ability of ensuring that at-risk populations will be 
protected from illness.

    Answer. On March 17, 2020, the administration transmitted an FY 
2021 budget amendment to Congress to increase funding for CDC in FY 
2021 to ensure that the agency had the resources beginning October 1, 
2020, to continue its critical public health mission. This amendment 
requested a total FY 2021 funding level of $8,329,102,000 for CDC, 
which is $1,328,196,000 above the FY 2021 budget request. The 
additional funding would support priority CDC activities, including 
preparedness and response and emerging and infectious diseases.

    The PHSSEF FY 2021 President's Budget proposed a decrease of 
approximately $96 million relative to the FY 2020 enacted level (about 
-3.5 percent). The most significant reduction in the PHSSEF FY 2021 
President's Budget was to ASPR's Project Bioshield, however the 
decrease reflected Congress's forward funding of procurement of Ebola 
countermeasures through emergency supplemental funding in FY 2020.
                           organ transplants
    Question. There is a well-documented history of discrimination 
against people with disabilities in organ transplant programs. Despite 
the Americans with Disabilities Act (ADA) and section 504 of the 
Rehabilitation Act prohibiting discrimination on the basis of 
disability, a number of States have found it necessary to enact laws to 
address continued barriers to receiving this lifesaving care. These 
barriers are reported to include medical professionals and transplant 
centers refusing to approve organ transplants for people with 
disabilities who may need help in order to follow complicated post-
transplant treatment plans, or deciding that people with disabilities 
should be given a lower priority on waiting lists to receive an organ 
transplant. Additional barriers include the lack of evaluation and 
referral to organ transplant specialist for people with disabilities.

    What plans does HHS have to take action against disability 
discrimination in organ transplantation and other areas in which life-
sustaining care is inappropriately withheld from people with 
disabilities?

    In what ways does HHS ensure people with disabilities receive 
evaluations and referrals to organ transplant specialist? Do you 
anticipate guidance or regulation on this topic in the coming year?

    Answer. The Office for Civil Rights (OCR) is concerned with 
discrimination against persons with disabilities and recognizes that 
this discrimination can extend to the organ transplant context and 
other areas in which life-sustaining care is inappropriately withheld. 
Specifically, OCR has reviewed the National Council of Disabilities 
(NCD) bioethics series and the reports on Organ Transplant 
Discrimination Against People With Disabilities: Part of the Bioethics 
and Disability Series (September 2019) and The Danger of Assisted 
Suicide Laws: Part of the Bioethics and Disability Series (October 
2019).

    The National Council on Disability underscored the following: 
discrimination continues to occur in the nine States that have enacted 
laws explicitly prohibiting such discrimination; that disabilities 
unrelated to a person's need for an organ transplant generally have 
little or no impact on the likelihood that the transplant will be 
successful; and that many organ transplant centers have policies that 
bar or caution against placing people with HIV, psychiatric 
disabilities, or intellectual and developmental disabilities (I/DD) on 
the waiting list to receive an organ transplant.

    In the report on assisted suicide, the National Council on 
Disability explains that persons with disabilities are often coerced to 
end their lives when faced with life-threatening conditions, even if 
the conditions are treatable. OCR has also received letters from 
Congress and stakeholders concerned about invidious steering of persons 
with disabilities into assisted suicide instead of suicide prevention 
treatments or resources. Similarly, OCR is aware of examples where 
doctors unilaterally enter ``do not resuscitate'' orders for patients 
with disabilities but not for patients without disabilities.

    In the organ transplant context, OCR favorably resolved a case in 
North Carolina last year, where a medical provider deemed an individual 
ineligible to be on a heart transplant wait list by citing the 
individual's autism even though the disability was irrelevant to the 
odds of success of the procedure. OCR has also received letters from 
Congress and met with stakeholders who have addressed disability 
discrimination.

    To address these issues, OCR is exploring issuing guidance or 
developing a proposed rulemaking to address the rights to be free from 
discrimination on the basis of disability in these contexts.
   advisory committee on heritable disorders in newborns and children
    Question. I have been a consistent supporter of newborn screening, 
which can identify infants born with conditions like phenylketonuria 
(PKU); my father pushed for Pennsylvania's PKU newborn screening law 
when he was Governor, and it was one of the accomplishments of which he 
was most proud. State newborn screening programs are supported by the 
Federal law, the Newborn Screening Saves Lives Act, which authorizes 
the Advisory Committee on Heritable Disorders in Newborns and Children 
(ACHDNC). The ACHDNC is tasked with providing recommendations to the 
Secretary of Health and Human Services regarding what conditions should 
be included in the ``recommended uniform screening panel,'' which then 
informs State policy on what heritable disorders they test for. The 
ACHDNC has been in operation for almost 20 years, and provides valuable 
recommendations regarding technologies, guidelines and standards to 
improve infant health and prevent infant deaths. However, the ACHDNC's 
statutory authority lapsed in October 2019, and the committee has had 
to halt its activities, preventing the committee from completing work 
underway when its authority lapsed or from starting new work.

    I understand that you, as Secretary, have the authority under the 
Public Health Service Act to immediately restart the committee's 
activities by renewing its charter. Will you take immediate steps to 
reconstitute the ACHDNC as soon as possible so it can continue its 
lifesaving work?

    Answer. Thank you for your interest in the Advisory Committee on 
Heritable Disorders in Newborns and Children (ACHDNC). The ACHDNC 
provides important advice, technical information and recommendations 
regarding genetic disorders, newborn screening, and childhood screening 
to the Secretary. HRSA is working with the Secretary's office to 
continue ACHDNC's activities as a discretionary committee.
                         physician fee schedule
    Question. I have heard concerns from constituents about payment 
changes in the 2020 Physician Fee Schedule (PFS) Final Rule that will 
have a negative impact on providers who do not regularly utilize 
Evaluation and Management (E&M) codes due to the nature of their 
specialty. In calculating these payment changes, did HHS take into 
account the negative impact on those specialties, and has it considered 
possible ways to ameliorate that impact?

    Answer. This administration is committed to strengthening Medicare, 
and this requires making changes that will lower costs while ultimately 
improving health outcomes for beneficiaries. We know it is critical 
that beneficiaries have access to the services they need, and HHS is 
dedicated to ensuring our policies promote this goal. The 2020 Medicare 
Physician Fee Schedule was finalized after undergoing the standard 
rulemaking process, which includes an extensive period for the public 
to provide comments.\20\ HHS greatly relies upon the input we receive 
from the health-care community as we make final policy decisions, and 
we look forward to continuing our work to improve the program while 
ensuring beneficiaries have access to the care they need, including 
services provided by clinicians such as physical therapists.
---------------------------------------------------------------------------
    \20\ Final Rule available at: https://www.federalregister.gov/
documents/2019/11/15/2019-24086/medicare-program-cy-2020-revisions-to-
payment-policies-under-the-physician-fee-schedule-and-other.

    The 2020 Physician Fee Schedule (PFS) final rule adjusted the 
relative value units (RVUs) for office and outpatient evaluation and 
management (E/M) visit codes effective beginning in 2021. The 
Department finalized the proposal to establish values based on 
recommendations by the American Medical Association Specialty Society 
Relative Value Scale Update Committee (RUC), which were based upon a 
survey of more than 50 specialty societies. We generally believe that 
the RUC-recommended values for these codes accurately reflect the 
resources involved in furnishing office and outpatient E/M visits and 
used them, with minor modifications, to establish values for these E/M 
---------------------------------------------------------------------------
visits.

    The Department received public comments on the 2020 PFS proposed 
rule in support of revaluing certain services relative to the new 
office/outpatient E/M visit values. In the 2021 PFS proposed rule, we 
are proposing to revalue the following services that include, rely upon 
or are analogous to the office/outpatient E/M visits commensurate with 
the increases in values finalized for office/outpatient E/M visits 
beginning in 2021: end stage renal disease monthly capitation payment 
services, transitional care management services, maternity packages, 
cognitive impairment assessment and care planning, the initial 
preventive physical examination and initial and subsequent annual 
wellness visits, emergency department visits, therapy evaluations 
(including services furnished by physical therapists, occupational 
therapists, and speech language pathologists), and psychiatric 
diagnostic evaluations and psychotherapy services. The proposed 
adjustments help to ensure that CMS is appropriately recognizing the 
kind of care where clinicians need to spend more face-to-face time with 
patients, like primary care and complex or chronic disease management. 
We are currently reviewing public comments on these proposals.

                                 ______
                                 
            Question Submitted by Hon. Robert P. Casey, Jr. 
                         and Hon. Sherrod Brown
         children's hospital graduate medical education funding
    Question. The budget proposes to merge several existing graduate 
medical education programs into a single capped grant program--
combining Medicare, Medicaid, and the Children's Hospital Graduate 
Medical Education program (CHGME), while cutting overall funding for 
GME at the same time. Pennsylvania and Ohio have nine children's 
hospitals with CHGME programs. We are concerned that a ``one size fits 
all'' program will not serve the unique needs of children. The health 
care needs of children are different than those of adults and the 
training needed to produce the pediatricians and other providers who 
provide that care are also different. CHGME is dedicated to supporting 
this training. In particular, CHGME plays a huge role in supporting the 
very specialized training that only occurs in many of our children's 
hospitals. We face national shortages of pediatric specialists and 
regional shortages of primary care pediatricians; going forward, how 
will HHS ensure that the needs of children will be met?

    Answer. Current graduate medical education funding is outdated, 
overly broad, and not sustainable long term due to its fragmented 
nature across multiple funding streams and lack of transparency and 
accountability. Effective in FY 2021, this proposal would consolidate 
Federal graduate medical education spending from Medicare, Medicaid, 
and the Children's Hospital Graduate Medical Education Program into a 
single grant program for teaching hospitals. Total funds available for 
distribution in FY 2021 would equal the sum of Medicare and Medicaid's 
2017 payments for graduate medical education, plus 2017 spending on 
Children's Hospital Graduate Medical Education, adjusted for inflation. 
This amount would then grow at the CPI-U minus one percentage point 
each year. Payments would be distributed to hospitals based on the 
number of residents at a hospital (up to its existing cap) and the 
portion of the hospital's inpatient days accounted for by Medicare and 
Medicaid patients. The new grant program would be jointly operated by 
the Administrators of CMS and the Health Resources and Services 
Administration.

    This grant program would be funded out of the general fund of the 
Treasury. The Secretary would have authority to modify the amounts 
distributed based on the proportion of residents training in priority 
specialties or programs (e.g., primary care, geriatrics) and based on 
other criteria identified by the Secretary, including addressing 
health-care professional shortages and educational priorities. These 
changes would modernize graduate medical education funding, making it 
better targeted, transparent, accountable, and more sustainable.

                                 ______
                                 
               Questions Submitted by Hon. Maggie Hassan
                           medicaid expansion
    Question. Your budget would end the enhanced Federal funding for 
Medicaid expansion. The Congressional Budget Office has concluded that 
this policy change would lead States to begin ending coverage for their 
expanded Medicaid population, which according to the Kaiser Family 
Foundation would put approximately 17 million Americans at risk of 
losing coverage, including 57,000 in New Hampshire.

    You testified at the hearing that these estimates were based off 
the President's Fiscal Year 2020 budget, rather than the FY 2021 
budget, yet while the mechanics of the FY 2021 policy differ from what 
was proposed in FY 2020, analysis from groups such as the Center on 
Budget and Policy Priorities estimates that the impact on expanded 
Medicaid, and potential impact to beneficiaries currently receiving 
coverage through expanded Medicaid, remains the same.

    Can you provide the analysis and data your Department relied on in 
order to conclude that ending enhanced Federal funding for Medicaid 
expansion in your FY 2021 budget would not lead States to eliminate the 
expanded Medicaid program and eliminate coverage for beneficiaries 
currently covered by expanded Medicaid in expansion States?

    Answer. Medicaid plays a pivotal role in ensuring access to 
quality, affordable health care for the most vulnerable Americans. The 
Department seeks to provide States with additional program financing 
options that will create opportunities for States to invest in their 
health-care infrastructure. The Trump administration understands that 
reforming Medicaid requires giving States the opportunity to implement 
Medicaid financing reforms that spur change and innovation; this 
requires affording States the ability to design State-based solutions 
that prioritize Medicaid dollars for the most vulnerable and support 
innovation while eliminating inefficient Medicare spending.

    Under the FY 2021 budget proposal, Medicaid spending would grow at 
a more sustainable rate by ending the financial bias that currently 
favors able-bodied working adults over the truly vulnerable and by 
permitting States to select between a per capita cap or a block grant. 
The budget reflects HHS's commitment to protecting the fiscal health of 
Medicaid and ensuring it remains a safety net for generations to come.
              substance use disorder treatment in medicaid
    Question. Your Department's Medicaid website notes that ``the 
evidence is strong that treatment in managing SUDs provides substantial 
cost savings.'' Can you provide the data that your Department used to 
arrive at this conclusion, including the estimated savings per Medicaid 
beneficiary achieved through robust access to substance use disorder 
treatment through Medicaid?

    Answer. The monetary costs and associated collateral impact to 
society resulting from substance use disorders (SUDs) are very high. In 
2009, for example, health insurance payers spent $24 billion for 
treating SUDs. Of the $24 billion, Medicaid accounted for 21 percent of 
the spending. The evidence is strong that treatment in managing SUDs 
provides substantial cost savings.\21\, \22\ For instance:
---------------------------------------------------------------------------
    \21\ https://www.medicaid.gov/medicaid/benefits/behavioral-health-
services/substance-use-disorders/index.html.
    \22\ https://www.medicaid.gov/federal-policy-guidance/downloads/
cib-07-11-2014.pdf.

        Persons with untreated alcohol use disorders use twice as much 
health care and cost twice as much as those with treated alcohol use 
disorders; and medications treating substance use disorder in pregnant 
women resulted in significantly shorter hospital stays than pregnant 
women with opioid disorder not receiving medication-assisted treatment 
(MAT) (10.0 days vs. 17.5 days).
        For inpatients with alcohol dependence, MAT was associated 
with fewer inpatient readmissions. Total health-care costs were 30 
percent less for individuals receiving MAT than for individuals who are 
not receiving MAT.
        Medical costs decreased by 30 percent on average between the 
year prior to MAT and the third year following treatment, and these 
cost trends reflect a decline in expenditures in all types of health-
care settings including hospitals, emergency departments, and 
outpatient centers.
        Medication-assisted treatment using Methadone for opioid use 
disorder treatment has been found to generate $4 to $5 in returns on 
health-care expenditures for every $1 invested.
        Early intervention for younger individuals with substance use 
disorders can bring costs down as they have lower pre-treatment costs 
than older adults with substance use disorders.
                      transparency within medicare
    Question. As we discussed at the hearing, the Department of Justice 
announced two concerning settlements in January of this year. The first 
was with Practice Fusion, Inc, an electronic health records vendor 
found to have taken money from Purdue Pharma to incorporate alerts into 
their electronic health record system that were intended to influence 
physician prescribing of Oxycontin. The second settlement was with 
Patient Services Inc, a copayment assistance program that was found to 
have taken money from Insys to provide Medicare copayment assistance 
for their fentanyl-based drug Subsys, including for off-label use.

    What tools does your Department have in place to identify these 
financial relationships in real time, in order to assess whether they 
are being used to influence prescribing in ways that pose risk to 
patients or raise Medicare spending by steering utilization?

    Answer. Under current law, HHS OIG has no authority to require 
private-sector businesses to report data on financial relationships 
involving the exchange of information between such parties in a manner 
that would permit OIG to do real time monitoring. Accordingly, HHS OIG 
has neither systems nor tools in place through which we would be able 
to regularly access, collect, and analyze real time information on 
financial relationships between drug manufacturers and their business 
partners in order to identify potentially inappropriate activity. 
Generally OIG gains access to such information through use of an IG 
subpoena or a search warrant pursuant to a particular law enforcement 
investigation, but this would not be ``real time'' data.

    Question. Does your department collect any data on payments from 
drug companies to non-profit copayment assistance programs, or payments 
to electronic health records vendors, that studies increasingly show 
have been used to influence prescribing and spending within the 
Medicare program?

    Answer. OIG does not routinely collect data on payments from drug 
companies to non-profit copayment assistance programs or payments to 
electronic health records vendors. While engaged in law enforcement 
activities, OIG may receive such information on an ad hoc basis in 
connection with an investigation.

    Question. In order to ensure compliance with the Federal anti-
kickback statute, does your department require patient assistance 
programs to annually disclose data on the funding received from drug 
manufacturers; the prescription drugs this funding is used to provide 
copayment assistance for; the patient population for which the funding 
is used? Given the number of settlements announced by Department of 
Justice with drug companies and patient assistance groups regarding 
violations of the anti-kickback statute, what improvements to HHS 
authority would allow the Office of Inspector General to collect annual 
data on patient assistance programs that would allow for real-time 
analysis of whether these programs are not violating Federal law?

    Answer. OIG does not have direct programmatic relationships with 
patient assistance programs and does not require annual reporting of 
the types of data outlined above. Even if OIG received this sort of 
data, data analysis alone is unlikely to permit the identification of 
instances of non-compliance with the Federal anti-kickback statute. The 
settlements referenced above resulted from extensive investigations 
into the details of the arrangements between the pharmaceutical 
manufacturer donors and the patient assistance programs and the 
intentions of the parties. OIG would be happy to speak further about 
these issues.
         electronic health records disclosure and transparency
    Question. Given the increasing influence electronic health record 
systems have on the provider to patient relationship, do you believe 
your Department has sufficient disclosure requirements in place to 
detect potentially problematic financial relationships between 
electronic health records vendors and other health care stakeholders?

    What steps are currently in place within your Department, including 
at the Office of the National Coordinator for Health Information 
Technology, to ensure that the certification process for electronic 
health records includes safeguards that protect patients and providers 
from unknowingly using products that have been developed with input or 
financial influence from stakeholders such as drug companies? Do you 
believe adding electronic health records vendors to the Medicare Open 
Payments database would improve your ability to identify problematic 
relationships between vendors and drug companies and providers?

    Answer. Lack of seamless data exchange in health care has 
historically detracted from patient care, leading to poor health 
outcomes, and higher costs. CMS's Interoperability and Patient Access 
final rule, published on March 9, 2020, establishes policies that break 
down barriers in the Nation's health system to enable better patient 
access to their health information, improve interoperability and 
unleash innovation, while reducing burden on payers and providers. 
Patients and their health-care providers will have the opportunity to 
be more informed, which can lead to better care and improved patient 
outcomes, while at the same time reducing burden.

    In addition, this rule modified CMS conditions of participation to 
require those hospitals that are appropriately equipped, including 
psychiatric hospitals and critical access hospitals, to send electronic 
patient event notifications of a patient's admission, discharge, or 
transfer to another health-care facility or to another community 
provider or practitioner. We believe that the capability to send 
patient event notifications should be a fundamental feature of hospital 
medical record systems to support effective care transitions and 
promote patient safety during transitions. This will improve care 
coordination by allowing a receiving provider, facility, or 
practitioner to reach out to the patient and deliver appropriate 
follow-up care in a timely manner. This policy will be applicable 
beginning May 1, 2021.
                    maternal mortality and morbidity
    Question. The President's Proposed Budget for Fiscal Year 2021 
includes a commitment from this administration to address the maternal 
mortality and morbidity crisis in the United States. As you know, a 
large number of the maternal mortality and morbidity cases among 
Americans can be attributed to complications before, during, and after 
childbirth that can be prevented when patients have access to adequate, 
quality prenatal and postpartum health-care services.

    Quality, affordable prenatal, and postpartum care for pregnant 
patients is the key to addressing the maternal mortality and morbidity 
rates in the United States. It is also critical that patients who may 
experience pregnancy in the future have access to quality primary care 
services throughout their lifetime to ensure the healthiest possible 
pregnancy and childbirth experience.

    While the proposed budget includes several maternal health policies 
that could help address this crisis, this budget as a whole would cause 
far more damage in access to prenatal and postpartum health-care 
services.

    How do you square this administration's commitment to improving 
maternal health outcomes when, at the same time, this administration is 
limiting access to reproductive health-care services through policies 
such as the title X gag rule and the proposed rule on Medicaid Block 
Grant program, that together would limit access to health care services 
for hundreds of thousands of individuals of reproductive age?

    Answer. HHS is committed to improving maternal health outcomes for 
families across the Nation. The FY 2021 budget proposes a new Improving 
Maternal Health in America initiative to address this significant 
public health problem. This initiative focuses on four strategic goals: 
achieve healthy outcomes for all women of reproductive age by improving 
prevention and treatment; achieve healthy pregnancies and births by 
prioritizing quality improvement; achieve healthy futures by optimizing 
postpartum health; and improve data and bolster research to inform 
future interventions.

    The budget proposes a total of $116 million for this initiative 
across the National Institute for Research on Safety and Quality 
(NIRSQ), CDC, HRSA, and IHS. This includes $7 million for NIRSQ to 
improve service data, advance data evaluation, and expand medical 
expenditure surveys to ensure policy makers have timely and accurate 
data. The budget also invests $24 million in CDC to expand the Maternal 
Mortality Review Committees to all 50 States to ensure every case of 
pregnancy-related death is examined. The budget provides $80 million in 
HRSA to improve the quality of maternal health services, expand access 
to care, and reduce disparities in care. The budget invests $5 million 
in IHS to help improve health outcomes by standardizing care, 
increasing cultural awareness, and improving care for pregnant women.

    Separate from the initiative, the FY 2021 budget maintains title X 
Family Planning funding flat with FY 2020 enacted at $286 million.
                            patient matching
    Question. As part of the fiscal year 2020 appropriations agreement, 
Congress required the Department of Health and Human Services to submit 
a report on how to improve patient matching--which is the ability to 
link medical records for the same person across multiple sites of care.

    While there may be longer-term steps that can be taken, research 
has shown that the Department of Health and Human Services can take 
steps today to improve patient matching--specifically through the use 
of common standards and data elements. For example, if the Office of 
the National Coordinator required use of the US Postal Service standard 
for home addresses in electronic health record systems (EHRs), match 
rates could improve by several percentage points.\23\
---------------------------------------------------------------------------
    \23\ https://www.pewtrusts.org/en/research-and-analysis/articles/
2019/03/22/standardized-demographic-data-aids-patient-matching-rates-
study-shows.

    What steps is the Office of the National Coordinator taking to 
require greater standardization of data for matching, including through 
---------------------------------------------------------------------------
use of the U.S. Postal Service standard?

    Answer. The HHS Office of the National Coordinator for Health 
Information Technology (ONC) is taking numerous steps to increase 
standardization of data. This includes incorporating the United States 
Core Data for Interoperability (USCDI), which is a standardized set of 
health data classes and consistent data elements for nationwide and 
interoperable health information. ONC develops and maintains USCDI as 
part of the ONC Health IT Certification Program. Within the 
demographics section of USCDI, ONC certified health IT requires a 
number of additional data elements to assist with patient matching, 
including an individual's address, previous address, phone number, 
phone number type (e.g., mobile), and email address. This expanded set 
of demographic data elements is used to support more accurate patient 
matching.

    Also, in the recent Cures Act Final Rule, ONC adopted the USCDI and 
required its use across a range of certification criteria adopted 
within the ONC Health IT Certification Program. This includes both 
document-based exchange and exchange through standardized application 
programming interfaces. The USCDI demographic data elements can be used 
to assist with patient matching across settings and service providers 
within the health care industry. ONC is currently collecting 
submissions to consider in the next version of the USCDI.

    In our Final Rule, we encouraged health IT developers and standards 
development organizations to improve address data quality through 
standardization and validation and by other means. In addition, we will 
continue to work with standards development organizations to evaluate 
potential solutions to improve patient matching, including considering 
the potential adaptability of the U.S. Postal Service formats for 
health IT use cases. Please see ONC 21st Century Cures Act Final Rule 
for further information: https://www.healthit.gov/sites/default/files/
cures/2020-03/ONC_Cures_Act_Final_Rule_03092020.pdf.

    In December 2019, a Congressional Appropriations Agreement for 2020 
directed ONC to provide a report to Congress, in coordination with 
other appropriate Federal agencies, studying and evaluating current 
technological and operational methods to improve identity and matching 
of patients. ONC conducted two public stakeholder sessions collecting 
input for consideration in the report. Presentation topics varied but 
several presentations addressed standards for matching within and 
between domains. ONC collected public input for incorporation into the 
report through Friday, September 4, 2020. In addition, ONC conducted 
three Federal working sessions to discuss Federal identity and record 
matching efforts. Participating agencies have been given an opportunity 
to provide input to be incorporated into the report. A list of ONC's 
recent patient identity and patient matching efforts can be found on 
HealthIT.gov at https://www.healthit.gov/topic/patient-identity-and-
patient-record-matching.
             electronic health record best safety practices
    Question. The Centers for Medicare and Medicaid Services recently 
released regulations with questions on how the agency can improve the 
safety of electronic health records. As you know, electronic health 
records are now ubiquitous, and research suggests that the design and 
implementation of these systems--often referred to as usability--can 
contribute to patient harm.

    One study examining 9,000 medication safety events found that a 
third of them occurred, in part, due to the usability of electronic 
health records.\24\ Research has identified best practices that 
hospitals can take to improve electronic health record safety, and the 
Centers for Medicare and Medicaid Services can encourage adoption of 
these practices through its programs.
---------------------------------------------------------------------------
    \24\ https://www.healthaffairs.org/doi/full/10.1377/
hlthaff.2018.0699.

    What steps are being taken by the Centers for Medicare and Medicaid 
Services to prioritize adoption of electronic health record safety best 
---------------------------------------------------------------------------
practices by hospitals?

    Answer. Lack of seamless data exchange in health care has 
historically detracted from patient care, leading to poor health 
outcomes, and higher costs. CMS's Interoperability and Patient Access 
final rule, published on March 9, 2020, establishes policies that break 
down barriers in the Nation's health system to enable better patient 
access to their health information, improve interoperability and 
unleash innovation, while reducing burden on payers and providers. 
Patients and their health-care providers will have the opportunity to 
be more informed, which can lead to better care and improved patient 
outcomes, while at the same time reducing burden.

    In addition, CMS modified conditions of participation to require 
hospitals that are appropriately equipped, including psychiatric 
hospitals and critical access hospitals, to send electronic patient 
event notifications of a patient's admission, discharge, or transfer to 
another health-care facility or to another community provider or 
practitioner. We believe that the capability to send patient event 
notifications should be a fundamental feature of hospital medical 
record systems to support effective care transitions and promote 
patient safety during transitions. This will improve care coordination 
by allowing a receiving provider, facility, or practitioner to reach 
out to the patient and deliver appropriate follow-up care in a timely 
manner. This policy will be applicable 12 months after publication of 
this rule.
               application programming interfaces (apis)
    Question. Recent proposed regulations from the Office of the 
National Coordinator and the Centers for Medicare and Medicaid Services 
on interoperability have a common thread: patients have a right to 
their health data and should be able to obtain the information in their 
chosen format--including a smartphone application. The regulations 
successfully achieve this by proposing the use of standard application 
programming interfaces (APIs), which allow different systems to 
communicate.

    When will the proposed rules be finalized?

    Additionally, can you elaborate on why standardizing application 
programming interfaces is a priority for the administration and why 
patients can benefit from getting their full medical records as set 
forth in the regulations?

    Answer. On March 9, 2020, the Department released these two 
transformative final rules to give patients unprecedented secure access 
to their health data. The two rules, issued by the Office of the 
National Coordinator for Health Information Technology (ONC) and 
Centers for Medicare & Medicaid Services (CMS), advance 
interoperability and patient access consistent with the bipartisan 21st 
Century Cures Act (Cures Act) and support President Trump's 
MyHealthEData initiative. This initiative is designed to empower 
patients around a common aim: giving every American access to their 
medical information so they can make better health-care decisions.

    Ensuring the privacy and security of patient information is a top 
priority for HHS. Identifying the right standards can help data flow 
securely and efficiently. The Department has identified Health Level 7 
(HL7) Fast Healthcare Interoperability Resources (FHIR) Release 4.0.1 
as the foundational standard to support data exchange via secure 
application programming interfaces (APIs). ONC's 21st Century Cures Act 
rule, at 45 CFR 170.215, finalized interoperability and security 
standards for FHIR-based APIs. CMS's rule applies those standards to 
patient-access APIs that CMS-regulated payers are required to 
implement.

    CMS-regulated payers, specifically Medicare Advantage 
organizations, Medicaid fee-for-service (FFS) programs, Medicaid 
managed care plans, CHIP FFS programs, CHIP managed care entities, and 
qualified health plan (QHP) issuers on the Federally Facilitated 
Exchanges--excluding issuers offering only stand-alone dental plans 
(SADPs) and QHP issuers offering coverage in the Federally Facilitated 
Small Business Health Options Program (FF-SHOP)--are required to 
implement and maintain a secure, standards-based (HL7 FHIR Release 
4.0.1) API that allows patients to easily access their claims and 
encounter information, including cost, as well as a defined sub-set of 
their clinical information through third-party applications of their 
choice. Claims data, used in conjunction with clinical data, can offer 
a broader and more holistic understanding of an individual's 
interactions with the health-care system, leading to better decision-
making and better health outcomes. These payers are required to 
implement the Patient Access API beginning January 1, 2021 (for QHP 
issuers on the FFEs, plan years beginning on or after January 1, 2021).

    When individuals have access to their health information, they can 
better coordinate their care and have greater control over their health 
and well-being. ONC's interoperability efforts focus on improving 
individuals' ability to control their health information so they can 
shop for and coordinate their own care.

    While many patients can access their medical information through 
multiple provider portals, the current ecosystem is frustrating and 
cumbersome. The more providers they have, the more portals they need to 
visit, the more usernames and passwords they need to remember. In the 
end, these steps make it hard for patients to aggregate their 
information across care settings and prevent them from being empowered 
consumers.

    API-based exchanges have become commonplace in our everyday life, 
from mobile banking to booking a plane ticket, from downloading media 
to shopping online. Naturally, as adoption of electronic health records 
(EHRs) continues to expand, it is essential for APIs to play an 
increasing role with respect to health-care interoperability.

    The need is evident. We use technology in so many facets of life. 
We send email, buy airline tickets, keep up with friends and family on 
social media, and order food from the convenience of our smartphones. 
Yet, obstacles continue to be encountered by patients trying to access 
their own electronic health information (EHI). It is time to change 
that paradigm.

    ONC thanks Congress for the passage of the Cures Act and we look 
forward to implementing the ONC final rule, which promotes patient 
access to their electronic health information, supports provider needs, 
advances innovation, and addresses 
industry-wide information blocking practices. Placing patients at the 
center of care is critical to all that we do at ONC and the final rule 
continues to advance that goal, including through provisions that 
support the ability of patients to securely and easily obtain their EHI 
at no additional cost when electronically accessed (e.g., by using the 
smartphone application of their choice).
                         e-cigarette flavor ban
    Question. In the weeks since the administration's partial ban on 
flavored e-
cigarettes went into effect, there have been news reports, as well as 
information provided to my office by pediatricians and teachers in New 
Hampshire, suggesting that a migration to flavored single-use e-
cigarette cartridges has already occurred in response to the partial 
flavor ban.

    How is your department evaluating this information on an ongoing 
basis to inform subsequent modifications to the flavor ban policy, 
given that the early reports from experts in the field suggest it is 
not achieving its intended result, which is to curb youth use of e-
cigarettes, and how quickly after evaluating this information would FDA 
announce and implement a policy change?

    Answer. On September 9, 2020, the U.S. Food and Drug 
Administration, in partnership with the Centers for Disease Control and 
Prevention, released new data from the 2020 National Youth Tobacco 
Survey (NYTS), which show 1.8 million fewer U.S. youth are currently 
using e-cigarettes compared to 2019. After 2 years of disturbing 
increases in youth e-cigarette use, HHS is encouraged by the overall 
significant decline reported in 2020. This is good news; however, the 
FDA remains very concerned about the 3.6 million U.S. youth who 
currently use e-cigarettes and we acknowledge there is work that still 
needs to be done to curb youth use.

    As a science-based regulatory agency, FDA continuously monitors the 
tobacco product marketplace to identify emerging trends. The Center for 
Tobacco Products (CTP) also monitors the latest published research 
through multiple working groups that develop and maintain a 
comprehensive understanding of the science behind tobacco products, 
including ENDS. We will continue to monitor the scientific literature 
and emerging data from national surveys and adjust our enforcement 
efforts and regulatory approach as appropriate.

    FDA will take appropriate action regarding tobacco products that 
are marketed without premarket authorization, including as warranted 
based on changed or new information, or to better address minors' use 
of those products. FDA's January 2020 ENDS guidance did not alter the 
fact that it is illegal to market any new tobacco product without 
premarket authorization. The agency has discretion to pursue 
enforcement action at any time against any deemed new tobacco product 
marketed without premarket authorization, regardless of whether it 
falls within one of the categories of enforcement priorities outlined 
in our January 2020 ENDS guidance.

    As noted above, FDA will prioritize enforcement against any ENDS 
product that continues to be sold and for which the agency has not 
received a premarket application. Based on several factors--including 
the likelihood of youth use or initiation--FDA will make the best use 
of agency resources to enforce against any other deemed new tobacco 
product that does not have the required premarket authorization.

    We are committed to addressing the public health crisis of youth e-
cigarette use by, among other things, focusing product review and 
enforcement on youth-appealing products and also investments in youth 
education campaigns regarding the dangers of e-cigarette use. We will 
remain vigilant in monitoring the marketplace, expanding our public 
education efforts and using our regulatory authority to further ensure 
that all tobacco products, and e-cigarettes in particular, are not 
marketed to, sold to, or used by kids. If we see a product that is 
targeted to kids, we will not hesitate to target that product.

    In addition, it is important to emphasize that FDA's Premarket 
Tobacco Product Application (PMTA) review process is grounded in 
science and law. In order for a product to receive market 
authorization, an application must demonstrate through studies, data, 
and thorough product details, that the marketing of the product meets 
the applicable standard in the law, ``appropriate for the protection of 
the public health.'' FDA considers youth initiation and use of a 
tobacco product when reviewing premarket applications. During review of 
premarket applications for ENDS products, FDA considers information on 
youth appeal, youth use, and evaluates that information in determining 
whether a tobacco product meets the statutory standard. FDA then 
conducts a rigorous scientific review of the information contained in 
each applicant's PMTA. If, after this review, FDA finds the ENDS 
product meets the statutory standard for authorization, among other 
requirements, it will issue a marketing order.

    FDA may require that an applicant restrict the sale and 
distribution of its product authorized via the PMTA pathway, to ensure 
that its marketing of the product does not result in youth use. The 
agency may also require that applicants apprise FDA of efforts to 
prevent youth access and exposure. FDA also continues to monitor 
products after they receive a marketing authorization, including 
assessing the potential for increased use among youth. Ultimately, FDA 
can withdraw a marketing order if, among other reasons, it determines 
that the continued marketing of a product is no longer appropriate for 
the protection of the public health.
                          buprenorphine waiver
    Question. Bipartisan legislation in both the Senate and House would 
eliminate the buprenorphine waiver requirement that imposes lengthy 
training requirements that may limit the number of providers willing to 
obtain a waiver, which limits patient access to medication-assisted 
treatment, particularly in rural areas.

    Given the public health benefit to expanded access to MAT as part 
of a comprehensive approach to treatment and recovery, and the known 
barriers created by this waiver requirement, is this administration 
supportive of efforts to eliminate the waiver requirement?

    Answer. The administration is conceptually supportive of 
eliminating the DATA 2000 Waiver, but there are a number of issues that 
need to be addressed in order for all health practitioners who are not 
yet waived to begin to practice and at this time the bills 
congressional members have introduced do not sufficiently address the 
concerns of the Federal interagency. We, along with colleagues at ONDCP 
and DOJ are available to offer technical assistance or draft 
legislative language and we recommend coordinating this through ONDCP 
who can bring the right experts to the table from the three agencies on 
behalf of the White House.
                             transportation
    Question. There is bipartisan agreement that difficulty accessing 
transportation in rural and underserved areas keeps people across the 
country from accessing needed medical care. In addition to difficulties 
securing rides to and from appointments, either by car or via public 
transportation, patients with mobility issues face additional 
transportation barriers and require assistance when trying to safely 
exit their home prior to accessing transportation, or enter an 
appointment after receiving transportation to care. What efforts are 
underway at your Department to provide support to those patients for 
whom the transportation barriers they face at the beginning and end of 
their trip may keep them from accessing more widely available 
assistance such as ride share services covered by their insurance plan, 
or discounted public transit programs?

    Answer. Under Federal regulations, States must assure both 
emergency and non-emergency medical transportation to all Medicaid 
beneficiaries.
                               telehealth
    Question. As providers work to expand access to telehealth services 
through investments in technology and improvements to provider 
reimbursement, what efforts are underway at your Department to ensure 
that patients, particularly seniors, will have access to the hardware 
they need, and the required training to operate that hardware, in order 
to facilitate uptake of telehealth services, particularly in rural and 
underserved communities?

    Does your Department require additional support from Congress to 
ensure that Medicare patients for whom telehealth services may be 
beneficial have access to the equipment and training they need in order 
to utilize these services?

    Answer. Ensuring access to health-care services in rural areas is a 
top priority for the Trump administration, and expanding the 
availability of telehealth services is an important part of this 
effort. On August 3, 2020, President Trump signed Executive Order 
13941, Executive Order on Improving Rural Health and Telehealth Access, 
demonstrating this commitment.

    During the COVID-19 public health emergency (PHE), we have seen a 
substantial increase in the use of telehealth services as access to in-
person care was limited to prevent the potential spread of the disease. 
The Department's analysis shows a weekly jump in virtual visits for CMS 
beneficiaries, from approximately 14,000 pre-PHE to almost 1.7 million 
in the last week of April. Additionally, a recent report by the 
Department shows that nearly half (43.5 percent) of Medicare fee-for-
service primary care visits were provided through telehealth in April, 
compared with far less than one percent (0.1 percent) in February 
before the PHE. Importantly, the report finds that telehealth visits 
continued to be frequent even after in-person primary care visits 
resumed in May, indicating that the expansion of telehealth services is 
likely to be a more permanent feature of the health-care delivery 
system.

    As directed by President Trump's Executive Order on Improving Rural 
and Telehealth Access, through the calendar year 2021 Medicare 
Physician Fee Schedule proposed rule, CMS is taking steps to extend the 
availability of certain telehealth services after the PHE ends, giving 
Medicare beneficiaries more convenient ways to access health care 
particularly in rural areas where access to health-care providers may 
otherwise be limited.

    During the public health emergency, CMS added 135 services such as 
emergency department visits, initial inpatient and nursing facility 
visits, and discharge day management services, that could be paid when 
delivered by telehealth. CMS is proposing to permanently allow some of 
those services to be done by telehealth including home visits for the 
evaluation and management of a patient (in the case where the law 
allows telehealth services in the patient's home), and certain types of 
visits for patients with cognitive impairments. CMS is seeking public 
input on other services to permanently add to the telehealth list 
beyond the PHE in order to give clinicians and patients time as they 
get ready to provide in-person care again. CMS is also proposing to 
temporarily extend payment for other telehealth services such as 
emergency department visits, for a specific time period, through the 
calendar year in which the PHE ends. This will also give the community 
time to consider whether these services should be delivered permanently 
through telehealth outside of the PHE.
                           dementia screening
    Question. The Office of Disease Prevention and Health Promotion at 
HHS has stated that Alzheimer's and other forms of dementia are more 
frequently undiagnosed among patients living in rural and underserved 
communities. Access to dementia screening at no cost as part of the 
Medicare wellness visit would provide patients and caretakers with 
critical information that could allow them to begin making 
modifications to their homes or care plans in order to prepare for a 
change in health status. However, there is resistance to covering 
dementia screening as a diagnostic service for which there is no 
curative treatment.

    Given the recent advances in efforts to find curative therapies for 
dementia and Alzheimer's, and the importance that an early diagnosis 
can play for patients, family members and caretakers who wish to 
proactively establish care plans in response to a diagnosis, do you 
support coverage for dementia screenings as part of annual wellness 
visits for seniors and at-risk patient populations?

    Answer. ``Detection of any cognitive impairment'' is currently a 
statutorily required element of the Medicare annual wellness visit 
(AWV). CMS's Medicare Learning Network for the AWV directs physicians 
and other practitioners to the National Institute on Aging's 
Alzheimer's and dementia resources for professionals for information on 
structured, validated cognitive assessment tools.
                    coronavirus (covid-19) response
    Question. As one of the administration officials tasked by the 
President with overseeing our Nation's coronavirus preparedness and 
response efforts, you are playing a role in a multi-agency effort to 
ensure the safety of Americans domestically and abroad.

    According to recent reporting, there has been confusion and 
conflict between the Centers for Disease Control and Prevention (CDC), 
the State Department, and other government officials regarding the 
appropriateness of transporting patients who are at risk of, or have 
been diagnosed with, Coronavirus, from locations overseas back to the 
United States. Can you explain how those decisions are made, and how 
public health input from CDC is balanced with the need to get patients 
back to the United States? Additionally, given what little we know 
about Coronavirus transmission, what precautions are in place to ensure 
that individuals traveling with diagnosed or at-risk patients in 
airplanes or to and from quarantine locations are sufficiently 
protected?

    Answer. Under U.S. law, the U.S. Department of State (DOS) may fund 
the repatriation of private, destitute U.S. citizens abroad to the 
United States on a reimbursable basis. Further under U.S. law, the 
Department of State may fund the evacuation, when their lives are 
endangered by war, civil unrest, or natural disaster, of private U.S. 
citizens or foreign nationals, on a reimbursable basis to the maximum 
extent practicable. CDC offers public health recommendations when 
appropriate. For additional questions, please contact DOS.

    Question. In late January, CDC distributed several hundred 
Coronavirus test kits to domestic and international locations to be 
used by public health officials for more expedited testing. Two weeks 
after those kits were distributed, these test kits were recalled by 
CDC. What is the timeline for the distribution and validation of new 
test kits?

    Answer. In early February, one of the three major components in 
CDC's test kits was problematic and the tests had to be recalled. In 
response, CDC validated the test's effectiveness without the 
problematic component; re-manufactured the test kits; obtained 
enforcement discretion from FDA to distribute the authorized test 
without the problematic component; and successfully distributed the new 
test kits on February 27th. The FDA reissued a revised EUA for this 
test on March 15th.
                       support act implementation
    Question. Your department has yet to meet several of its statutory 
obligations under the SUPPORT Act, including provisions requiring the 
Centers for Medicare and Medicaid Services (CMS) to provide guidance to 
States seeking to promote innovative approaches to serving 
beneficiaries with substance use disorder. According to an article 
published by Inside Health Policy on February 24, 2020, CMS has 
produced only one of seven guidance documents that were due in calendar 
year 2019 regarding substance use disorder treatment and services for 
Medicaid beneficiaries. Specifically, these documents would provide 
States with guidance on topics such as:

        Reimbursement options for substance use disorder treatments--
including medication-assisted treatment--that can be delivered via 
telehealth.
        Opportunities to finance and improve family-focused 
residential treatment programs.
        Recommendations for improving care for infants with neonatal 
abstinence syndrome and their families.
        Best practices for ensuring Medicaid coverage of former foster 
youth.
        Best practices for prescription drug monitoring programs and 
privacy protections for Medicaid beneficiaries.

    Please provide an update on the status of these critical guidance 
documents, reasons for their delay, and the date by which you plan to 
provide this guidance to States as required by the SUPPORT Act.

    Answer. Combating the opioid epidemic is a top priority for the 
Trump administration. To date, the Department has taken significant 
steps to carry out provisions in the SUPPORT Act while advancing the 
goals of our Five-Point Strategy. This comprehensive, evidence-based 
strategy aims to: improve access to prevention, treatment, and recovery 
support services to prevent the health, social, and economic 
consequences associated with substance use disorders and to help 
individuals to achieve long-term recovery; strengthen public health 
data collection and reporting to improve the timeliness and specificity 
of data and to inform a real-time public health response as the 
epidemic evolves; advance the practice of pain management to enable 
access to high quality, evidence-based pain care that reduces the 
burden of pain for individuals, families, and society while also 
reducing the inappropriate use of opioids and opioid-related harms; 
target the availability and distribution of overdose-reversing 
medications to ensure the broad provision of these drugs to people 
likely to experience or respond to an overdose, with a particular focus 
on targeting high-risk populations; and support cutting-edge research 
that advances our understanding of pain and addiction, leads to the 
development of new treatments, and identifies effective public health 
interventions to reduce drug-related health harms.

    The SUPPORT Act has been an essential enabler of HHS efforts to 
confront the opioid crisis. Through new and expanded authorities 
granted by the SUPPORT Act, we have been able to expand the scope and 
effectiveness of our programs across nearly the entire Department in 
order to deliver meaningful results related to the substance use 
crisis.

    The Department is continuing to implement provisions of the SUPPORT 
Act during the COVID-19 public health emergency (PHE). For example, CMS 
published the Medicaid Program; Establishing Minimum Standards in 
Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based 
Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug 
Rebate and Third Party Liability (TPL) Requirements proposed rule in 
the Federal Register (85 FR 37286) on June 19, 2020. This proposed rule 
would amend this section of the regulation to implement new opioid-
related DUR standards that are required of States under section 1004 of 
the SUPPORT for Patients and Communities Act, as well as additional 
opioid-related DUR standards that CMS is proposing under the authority 
of section 1927 of the Social Security Act. Most recently, on September 
4, 2020, CMS issued guidance to States regarding opportunities to 
improve care for infants with Neonatal Abstinence Syndrome (NAS) and 
their families, as required by section 1005(a) of the SUPPORT Act. In 
addition, this has included a CMS informational bulletin issued on 
April 2, 2020, that provided State Medicaid agencies and other 
interested stakeholders information about options to facilitate access 
to services and treatment of substance use disorder through the use of 
telehealth delivery methods as outlined in section 1009(b) of the 
SUPPORT Act. The bulletin includes details and guidance on Medicaid 
coverage of assessment, medication-assisted treatment, counseling, and 
medication management using telehealth solutions.

                                 ______
                                 
           Questions Submitted by Hon. Catherine Cortez Masto
    Question. In 2018, the President signed into law the BOLD 
Infrastructure for Alzheimer's Act, and in December 2019, Congress 
funded BOLD Act grants. The budget proposes to discontinue CDC's work 
on chronic disease management and surveillance, and cut funding for 
Alzheimer's work conducted by CDC. How much less funding would this 
budget propose for such work? What activities that the CDC performs or 
funds would be discontinued as a result?

    Answer. The President's budget proposes funding the Alzheimer's 
disease program at $3,493,000, which is a reduction of $12 million from 
the FY 2020 enacted level. At this level, CDC would continue to fund 
national organizations to implement the National Healthy Brain 
Initiative's State and Local Public Health Partnerships to Address 
Dementia: The 2018-2023 Road Map. Activities for implementation with 
specific population groups and at the national level would have to be 
scaled back. The surveillance and analysis of data about cognitive 
decline and caregiving through the Behavioral Risk Factor Surveillance 
System (BRFSS) and the National Health and Nutrition Examination Survey 
(NHANES) would not continue. In addition, the new awards to implement 
the BOLD Act would not continue, which includes funding for three 
Public Health Centers for Excellence (Risk Reduction, Early Diagnosis, 
and Caregiving) and funding for programmatic activities in 14 States, 
one large county, and one tribal organization. Programmatic recipients 
are focusing on changing systems, environments and policies to promote 
risk reduction, to improve early diagnosis, to prevent and manage 
comorbidities, and to avoid hospitalizations.

    Question. Many of the entities who use title X in rural Nevada rely 
on registered nurses and public health nurses to serve patients. The 
recent rule excludes registered nurses from performing pregnancy 
counseling--a duty well within their scope of practice. As recently as 
December CMS wrote about the ``burden'' of Federal rules that ``limit 
health professionals from practicing at the top of their license.''\25\ 
Why is this case an exception to that principle?
---------------------------------------------------------------------------
    \25\ CMS.

    Answer. The Office of Population Affairs (OPA) recognizes that the 
clinical site workforce varies greatly across the title X network and 
continues to show flexibility when working with individual grantees to 
ensure quality patient care as well as compliance with the statutes, 
---------------------------------------------------------------------------
legislative mandates, and regulations associated with title X funding.

    Under the title X Final Rule, nondirective counseling may be 
provided by physicians and advanced practice providers. The final rule 
defines ``advanced practice providers'' as a medical professional who 
receives at least a graduate level degree in the relevant medical field 
and maintains a license to diagnose, treat, and counsel patients. The 
term Advanced Practice Provider includes physician assistants and 
advanced practice registered nurses (APRN). Examples of APRNs that are 
an Advanced Practice Provider include certified nurse practitioner 
(CNP), clinical nurse specialist (CNS), certified registered nurse 
anesthetist (CRNA), and certified nurse-midwife (CNM). These examples 
were selected as APPs due to their advanced medical degrees, licensing, 
and certification requirements.

    Question. Among the proposed ``major savings and reforms,'' this 
budget calls for the elimination of ``fourteen health professions 
training programs that provide funds to training institutions to 
improve the Nation's health workforce.'' One of the programs targeted 
for elimination appears to be the State Offices of Rural Health 
program. Why did you cut funding for State Offices of Rural health?

    What other programs do you envision would do the work that State 
Office of Rural Health is conducting?

    Answer. HHS has a four-point strategy to transform rural health: 
build a sustainable health model for rural communities; leverage 
technology and innovation; focus on preventing disease and mortality; 
and increase rural access to health care.

    The budget invests $6.5 billion, an increase of +$122 million or 2 
percent, above FY 2020 to increase quality care to rural areas through 
programs in HRSA, SAMHSA, and IHS.

    Question. Have you increased the programs that provide direct 
service delivery by the same amount?

    Answer. The budget includes proposals that enhance access to SUD 
treatment and policies that will lead to better outcomes for new 
mothers. The budget invests $1.1 billion in discretionary spending in 
FY 2021 in SAMHSA programs, a +$42 million increase above FY 2020. The 
budget also request $6.2 billion for the Indian Health Service (IHS). 
This investment is strategic to make the greatest impact on health 
outcomes across Indian Country.

    Question. Mental health is a major stated policy priority for you 
and the President. Would you call mental health parity an essential 
provision of mental health services access?

    Do you think insurance carriers are fulfilling their obligations to 
that end?

    If not, what is this administration doing to ensure compliance and 
hold them accountable?

    Answer. A key part of the administration's effort to improve access 
to mental health services is working with our partners across the 
Federal Government and, with States and the provider and plan community 
to make stakeholders aware of the requirements of the Mental Health 
Parity and Addiction Equity Act (MHPAEA), to promote compliance with 
and enforce the law and regulations. The Department provides technical 
assistance to States, issuers, and plans in response to numerous 
complex questions regarding Mental Health Parity requirements. The 
Department works closely with States both on a one-to-one basis and, 
with the Department of Labor, through participation in the National 
Association of Insurance Commissioners' Mental Health Parity and 
Addiction Equity Act (B) Working Group.

    Since the enactment of MHPAEA, Federal agencies have released 
additional regulations and guidance to assist consumers and State 
regulators in understanding MHPAEA requirements. The Department, along 
with the Departments of Labor and the Treasury, and other Federal 
agencies have issued regulations to implement the law and continue to 
issue guidance and publications to address discrete issues raised by 
stakeholders. For example, the Departments have clarified in previous 
regulations and guidance the breadth of disclosure required, as well as 
which documents participants, beneficiaries, and their authorized 
representatives have a right to receive (and generally may find 
helpful) under MHPAEA, the Employee Retirement Income Security Act of 
1974 (ERISA), and the PPACA. Moreover, in light of the ongoing opioid 
epidemic, FAQs also included clarifications related to commonly found 
non-quantitative treatment limits that reduce access to substance use 
disorder treatments in particular. Such guidance and publications also 
include documentation on State best practices to promote parity 
compliance, and tools for reporting parity violations. The Departments 
of Labor and HHS also released a document which identifies plan 
provisions and health insurance benefit design elements that are red 
flags for parity limitations that are potentially impermissible.

    In addition, Federal agencies have been committed to enforcing the 
law, promoting compliance, assisting consumers, and conducting 
investigations. With respect to health insurance issuers selling health 
insurance products in the individual and group markets, States have 
primary enforcement authority with respect to title XXVII of the Public 
Health Service Act (PHS Act). HHS only enforces a provision of title 
XXVII of the PHS Act in a State if the State is not substantially 
enforcing the provision (PHS Act Sec. 2723(a)(1) and (2)). Currently, 
HHS is responsible for the enforcement of MHPAEA with respect to 
issuers selling products in the individual and fully insured group 
markets in three States: Missouri, Texas, and Wyoming. The Department 
conducts market conduct examinations of health insurance issuers in 
these three States and in States that have a collaborative enforcement 
agreement with HHS if the State requests such an examination in order 
to obtain issuer compliance with a Federal requirement.\26\ In 
addition, the Department and the Department of Labor conduct 
investigations of MHPAEA complaints for non-Federal governmental plans 
and ERISA plans, respectively.\27\ The most recent report of the 
Department's and the Department of Labor's MHPAEA enforcement actions 
can be found at https://www.cms.gov/CCIIO/Resources/Forms-Reports-and-
Other-Resources/Downloads/mhpaea-enforcement-2019.pdf.
---------------------------------------------------------------------------
    \26\ HHS will enter into a collaborative enforcement agreement with 
any State that is willing and able to perform regulatory functions but 
lacks enforcement authority. If the State finds a potential violation 
and is unable to obtain voluntary compliance from an issuer, it will 
refer the matter to HHS for possible enforcement action.
    \27\ Sponsors of self-funded, non-Federal governmental plans may 
opt out of certain requirements of title XXVII of the PHS Act, 
including MHPAEA. In all States, HHS has authority to initiate an 
investigation or a market conduct examination to determine whether a 
non-Federal governmental plan that has not filed a valid MHPAEA opt-out 
is out of compliance with MHPAEA.

    Question. Relaxed oversight of the managed care organizations that 
would deliver Medicaid coverage under the proposed Medicaid block grant 
would at best keep the status quo of mental health parity, and at worst 
give license to MCOs to fail to meet that objective without 
---------------------------------------------------------------------------
ramification. Does this concern you?

    Answer. HHS's proposed budget will have Medicaid spending grow at a 
more sustainable rate by ending the financial bias that currently 
favors able-bodied working-age adults over the truly vulnerable.

    The Healthy Adult Opportunity (HAO) is not a mandatory change in 
the Medicaid program's structure or financing--this is an optional 
demonstration opportunity, and no State is under any obligation to 
participate. It is also not permission for States to strip benefits or 
limit eligibility--under HAO, participating States must still meet 
minimum benefit requirements and cannot cap or limit adult enrollment 
while still receiving enhanced Federal funding.

    Under the HAO demonstration, States will be given the opportunity 
to elect one of two options to measure and monitor access and 
availability of Medicaid services in a managed care delivery system. 
States generally will be expected to meet specified managed care 
statutory requirements that provide beneficiary protections, facilitate 
beneficiary decision making, support access to services, monitor 
program administration, and measure the quality of the delivery system. 
For example, States will be expected to certify that their managed care 
plans have the capacity to meet the State's standards for access to 
care and availability of services. However, States will have 
flexibility under this demonstration to propose alternative approaches 
to ensure network adequacy, access to care, and availability of 
services to those required in current Federal regulations. The State 
would need to develop and propose alternative standards subject to CMS 
approval and provide reasonable evidence of enrollee access to care and 
satisfaction. Regardless of the approach elected, all States 
participating in the HAO will be required to submit routine data 
reports described in the Monitoring and Evaluation section of the 
guidance.

    A number of States have expressed interest in HAO and are 
supportive of the demonstration, which represents an innovative and 
historic approach to surmounting Medicaid's structural challenges while 
still providing rigorous protections for all Medicaid beneficiaries. At 
this time, Utah and Tennessee have submitted applications to amend 
their section 1115 waiver demonstrations to seek flexibilities to test 
innovative Medicaid financing models similar to the flexibilities 
offered under HAO.

    Question. Section 208 of the Prescription Drug Pricing Reduction 
Act as approved by this committee allows States to enter into multi-
year contracts with pharmaceutical manufacturers for the purchase of 
multimillion-dollar drugs for Medicaid beneficiaries. If a State took 
advantage of the flexibility to waive coverage of certain drugs in the 
Healthy Adult Opportunity block-grant proposal, would you expect that 
same State to go to the trouble of contracting with a drug company to 
pay millions of dollars over several years for a drug that it doesn't 
have to cover in the first place?

    Answer. This budget endorses bipartisan, bicameral drug pricing 
legislation like the Prescription Drug Pricing Reduction Act (PDPRA). 
But it is difficult to opine on how the PDPRA would interact with the 
Healthy Adult Opportunity (HAO) until we would see more final bill text 
supported by both chambers of Congress.

    Question. This budget would cut and consolidate the graduate 
medical education programs that train physicians and calls for $50 
billion in cuts without any corresponding reinvestment in health 
workforce training. It does not propose to redistribute physician slots 
to areas of need, instead opting to make payments based on the number 
of physicians an institution is currently training. What solution would 
you offer to States like Nevada, Montana, Idaho, Alaska, Wyoming, or 
South Dakota, any of those States whose physician training programs are 
the smallest in the country? How do they build their programs?

    Various members of Congress on both sides of the aisle and the 
capitol have written to you asking that you provide special exceptions 
to GME rules that would support workforce development in rural and 
underserved areas--you haven't elected to use that authority. Do you 
expect to do so in the future?

    Answer. Current graduate medical education funding is outdated, 
overly broad, and not sustainable long term due to its fragmented 
nature across multiple funding streams and lack of transparency and 
accountability. Effective in FY 2021, this proposal would consolidate 
Federal graduate medical education spending from Medicare, Medicaid, 
and the Children's Hospital Graduate Medical Education Program into a 
single grant program for teaching hospitals. Total funds available for 
distribution in FY 2021 would equal the sum of Medicare and Medicaid's 
2017 payments for graduate medical education, plus 2017 spending on 
Children's Hospital Graduate Medical Education, adjusted for inflation. 
This amount would then grow at the CPI-U minus one percentage point 
each year. Payments will be distributed to hospitals based on the 
number of residents at a hospital (up to its existing cap) and the 
portion of the hospital's inpatient days accounted for by Medicare and 
Medicaid patients. The new grant program would be jointly operated by 
the Administrators of CMS and the Health Resources and Services 
Administration.

    This grant program would be funded out of the general fund of the 
Treasury. The Secretary would have authority to modify the amounts 
distributed based on the proportion of residents training in priority 
specialties or programs (e.g., primary care, geriatrics) and based on 
other criteria identified by the Secretary, including addressing 
health-care professional shortages and educational priorities. These 
changes modernize graduate medical education funding, making it better 
targeted, transparent, accountable, and more sustainable.

    Question. Do you believe that we can fully address care quality and 
abuse and neglect in nursing homes without paying more for the care 
that those facilities deliver?

    Answer. Within the Department, the Centers for Medicare and 
Medicaid Services (CMS) sets and oversees minimum health and safety 
requirements that nursing homes must meet to participate in the 
Medicare and Medicaid programs, including requirements for infection 
control and prevention. State Survey Agencies, under agreements with 
the Secretary, conduct inspections, known as surveys, to observe and 
certify to CMS a facility's compliance with these requirements. CMS's 
commitment to improving and protecting nursing home residents' health 
and safety has never been stronger, and this focus is not new. In 2019, 
the agency announced a five-part strategy for ensuring safety and 
quality in Medicare and Medicaid participating nursing homes. This 
strategy outlined the steps the agency has taken and plans to take to 
keep nursing home residents safe: strengthening oversight, enhancing 
enforcement, increasing transparency, improving quality, and putting 
patients over paperwork. This framework serves as the agency's guide to 
making enhancements and improvements in ensuring nursing home safety 
and quality.

    During the COVID-19 public health emergency, CMS has issued 
extensive guidance and tools for nursing homes to use to make sure they 
have the flexibilities they need to combat the COVID-19 pandemic while 
keeping residents safe. A chart listing all of CMS's guidance documents 
and updates for nursing homes during this pandemic can be accessed at: 
https://www.cms.gov/files/document/covid-guidance-and-updates-nursing-
homes-during-covid-19.pdf.

    In addition, CMS has also provided extensive individualized 
technical assistance to nursing homes in an effort to help reduce 
transmission and the risk of COVID-19 spread among residents. This has 
included work by the Quality Improvement Network-Quality Improvement 
Organizations (QIN-QIOs)--groups composed of health quality experts, 
clinicians, and consumers that CMS contracts with to improve the 
quality of care delivered to Medicare beneficiaries--that have directly 
contacted, visited and worked with nursing homes with a high number of 
infection control deficiencies. Beginning in July, the Department 
additionally deployed Federal Task Force Strike Teams to provide onsite 
technical assistance and education to nursing homes experiencing 
outbreaks. The Task Force Strike Teams were composed of clinicians and 
public health service officials from CMS, the Centers for Disease 
Control and Prevention, and the Office of the HHS Assistant Secretary 
for Health. HHS is coordinating the nursing home activities of QIN-QIOs 
and Task Force Strike Teams to avoid duplication of efforts at 
facilities with infection control deficiencies that are also 
experiencing outbreaks.

    Question. Can you say with certainty that seniors who rely on their 
State's Medicaid program for nursing home coverage will experience zero 
change in their coverage and benefit should their State adopt the 
Healthy Adult Opportunity plan?

    Answer. The Healthy Adult Opportunity (HAO) emphasizes the concept 
of value-based care while granting States with extensive flexibility to 
administer and design their programs within a defined budget. This 
State opportunity will enhance the Medicaid program's integrity through 
its focus on accountability for results and quality improvement, making 
the Medicaid program stronger for States and beneficiaries.

    HAO is available to all States, with a focus on a limited 
population--adults under age 65 who are not eligible for Medicaid on 
the basis of disability or their need for long term care services and 
supports, and who are not eligible under a State plan. Other very low-
income parents, children, pregnant women, elderly adults, and people 
eligible on the basis of a disability will not be directly affected--
except from the improvements that result from States reinvesting 
savings into strengthening their overall programs. Under HAO, 
beneficiaries will maintain all of the Federal due process and civil 
rights they have today, and HAO demonstrations will be expected to 
provide minimum benefit standards, eligibility protections, and limits 
on out-of-pocket expenses.

    Question. Last fall GAO published a report touting the huge 
benefits of third party revenue to IHS. Those dollars help IHS 
facilities to make system improvements from hiring new providers all 
the way to keeping the heat on.\28\ Would you agree with GAO's 
conclusion that expanded health insurance coverage is beneficial to IHS 
operations?
---------------------------------------------------------------------------
    \28\ GAO.

    Answer. GAO reported that increased collections have allowed IHS to 
expand services and service complexity provided offsite through the 
---------------------------------------------------------------------------
Purchased/Referred Care (PRC) program.

    Question. Do you think HHS could do more to increase enrollment 
among American Indians and Alaskan Natives in the health coverage for 
which they are eligible?

    Answer. HHS/IHS does its best to ensure that American Indian and 
Alaska Natives (AI/AN) are enrolled in health coverage for which they 
may be eligible. For many AI/AN consumers as well as enrollment 
assisters, locating and reviewing current information related to 
enrollment specific to AI/ANs can be overwhelming. One idea that has 
been raised by the National Indian Health Board, one of IHS' partners 
and the recipient of a 3-year cooperative agreement under the IHS 
National Indian Health Outreach and Education initiative, is to develop 
a single website that gathers all of the information in one central 
place which will improve efficiency and ease the enrollment process.

    Question. The coronavirus outbreak is a stark reminder of the need 
to be prepared for public health threats. I am concerned the 
administration is not heeding this lesson with regards to the growing 
crisis of antibiotic resistance. Without antibiotics, common medical 
procedures such as surgeries and cancer chemotherapy will carry 
significant risk of untreatable infections. However, the efficacy of 
current antibiotics and the volume of antibiotics in the development 
pipeline are not keeping up with current or future needs. In fact, two 
companies with a combined five antibiotics on the market filed for 
bankruptcy last year alone. The administration has yet to articulate a 
strategy for reversing this dangerous trend. Please describe your 
immediate shorter term plans to mitigate the effects of these 
bankruptcies and your longer-term plan to ensure a robust 
infrastructure to develop and commercialize antibiotics to meet urgent 
threats.

    Answer. Antibacterial resistance remains an important public health 
crisis. BARDA has provided over $1.2 billion in non-dilutive funding 
and technical support to early stage product developers, via our CARB-X 
project, and to clinical stage product developers under our Advanced 
Research and Development (ARD) portfolio. These resources have ensured 
product developers have access to the tools and support to bring 
innovative life-saving antibiotics from the bench to the market that 
overcome the evolving threat of antibiotic resistance. Importantly, 
with this funding, BARDA has established a robust portfolio composed of 
CARB-X, with over 30 candidates in development, and 16 advanced 
development public-private partnerships focused on the development of 
16 novel, small molecule candidates. Through Project BioShield (PBS), 
BARDA has entered into a partnership with Paratek Pharmaceuticals worth 
up to $285 million to support the clinical development and approval of 
omadacycline for post-exposure prophylaxis and treatment of a 
biothreat. Under this agreement, the USG will procure and stockpile 
omadacycline in the Strategic National Stockpile. Omadacycline is also 
active against multidrug resistant bacteria, and is thus promising for 
providing additional protection against antibiotic resistant bacteria 
such as those diagnosed in COVID-19 patients. Funding the development 
of new, life-saving antibiotics and their procurement under PBS, 
affirms our commitment to support the antibiotic industry and fulfills 
the mission of Project BioShield: to enhance the biomedical 
preparedness of the Nation by providing a market incentive that rewards 
successful medical countermeasure development.

                                 ______
                                 

                                                    Medicaid Projections: President's FY 2021 Budget
                                                              (Office of the Actuary, CMS)
 
                                       2018     2019     2020     2021     2022     2023     2024     2025     2026     2027     2028     2029     2030
 
1. Medical assistance payments
 (benefits)
 
Expenditures (in billions)
 
Total expenditures--HHS                588.2    608.6    657.2    679.2    716.4    761.9    801.2    848.3    910.1    964.8  1,023.7  1,097.0  1,166.5
Federal expenditures--HHS              368.9    386.0    410.2    425.4    448.4    476.5    500.7    529.8    567.4    601.1    637.3    682.1    724.6
 
Annual growth rates
 
Total expenditures                               3.5%     8.0%     3.4%     5.5%     6.4%     5.2%     5.9%     7.3%     6.0%     6.1%     7.2%     6.3%
Federal expenditures                             4.6%     6.3%     3.7%     5.4%     6.3%     5.1%     5.8%     7.1%     5.9%     6.0%     7.0%     6.2%
 
2. Enrollment
 
Enrollment (in millions of average
 annual enrollees)
Eligibility category
 
Aged enrollees                           6.0      6.1      6.3      6.4      6.7      6.9      7.1      7.3      7.5      7.7      8.0      8.2      8.4
Enrollees with disabilities             10.3     10.2     10.2     10.3     10.4     10.5     10.5     10.6     10.7     10.8     10.9     11.0     11.1
Children                                29.6     28.9     28.5     28.5     28.9     29.2     29.5     29.7     30.0     30.2     30.5     32.8     33.7
Adults                                  15.6     15.2     14.9     14.8     14.8     14.9     15.0     15.0     15.1     15.1     15.2     15.2     15.3
Expansion adults                        12.2     12.1     12.3     12.6     12.6     12.7     12.7     12.8     12.8     12.9     12.9     13.0     13.0
Territory enrollees                      1.4      1.4      1.4      1.4      1.4      1.4      1.4      1.4      1.4      1.4      1.4      1.4      1.4
Total                                   75.1     73.9     73.6     74.0     74.8     75.5     76.2     76.8     77.5     78.1     78.8     81.5     82.8
 
Annual growth rates
Eligibility category
 
Aged enrollees                                   1.7%     3.3%     1.6%     4.7%     3.0%     2.9%     2.8%     2.7%     2.7%     3.9%     2.5%     2.4%
Enrollees with disabilities                     -1.0%     0.0%     1.0%     1.0%     1.0%     0.0%     1.0%     0.9%     0.9%     0.9%     0.9%     0.9%
Children                                        -2.4%    -1.4%     0.0%     1.4%     1.0%     1.0%     0.7%     1.0%     0.7%     1.0%     7.5%     2.7%
Adults                                          -2.6%    -2.0%    -0.7%     0.0%     0.7%     0.7%     0.0%     0.7%     0.0%     0.7%     0.0%     0.7%
Expansion adults                                -0.8%     1.7%     2.4%     0.0%     0.8%     0.0%     0.8%     0.0%     0.8%     0.0%     0.8%     0.0%
Territory enrollees                              0.0%     0.0%     0.0%     0.0%     0.0%     0.0%     0.0%     0.0%     0.0%     0.0%     0.0%     0.0%
Total                                           -1.6%    -0.4%     0.5%     1.1%     0.9%     0.9%     0.8%     0.9%     0.8%     0.9%     3.4%     1.6%
 
3. Per enrollee spending
 
Federal expenditures per enrollee
 P(in dollars per enrollee)
Eligibility category
 
Aged enrollees                         8,665    8,695    9,264    9,641   10,030   10,446   10,870   11,315   11,789   12,294   12,820   13,371   13,980
Enrollees with disabilities           12,329   12,717   13,805   14,425   15,100   15,847   16,657   17,514   18,425   19,393   20,411   21,481   22,621
Children                               2,176    2,284    2,522    2,648    2,774    2,908    3,049    3,198    3,356    3,524    3,701    3,871    4,061
Adults                                 3,112    3,865    3,807    3,997    4,183    4,379    4,585    4,803    5,033    5,273    5,525    5,788    6,064
Expansion adults                       5,673    6,199    6,510    6,763    7,070    7,394    7,737    8,098    8,480    8,882    9,304    9,745   10,206
Total                                  4,816    5,183    5,542    5,810    6,082    6,376    6,689    7,020    7,373    7,746    8,138    8,425    8,820
 
Annual growth rates
Eligibility category
 
Aged enrollees                                   0.3%     6.5%     4.1%     4.0%     4.1%     4.1%     4.1%     4.2%     4.3%     4.3%     4.3%     4.6%
Enrollees with disabilities                      3.1%     8.6%     4.5%     4.7%     4.9%     5.1%     5.1%     5.2%     5.3%     5.2%     5.2%     5.3%
Children                                         5.0%    10.4%     5.0%     4.8%     4.8%     4.8%     4.9%     4.9%     5.0%     5.0%     4.6%     4.9%
Adults                                          24.2%    -1.5%     5.0%     4.7%     4.7%     4.7%     4.8%     4.8%     4.8%     4.8%     4.8%     4.8%
Expansion adults                                 9.3%     5.0%     3.9%     4.5%     4.6%     4.6%     4.7%     4.7%     4.7%     4.8%     4.7%     4.7%
Total                                            7.6%     6.9%     4.8%     4.7%     4.8%     4.9%     4.9%     5.0%     5.1%     5.1%     3.5%     4.7%
 
 
Notes:
1. Medical assistance payment expenditures exclude certain adjustments, such as claims incurred but not yet reported.
2. Expenditures per enrollee exclude the following expenditures: disproportionate share hospital (DSH) collections; other unallocated expenditures; and
  territory expenditures.
3. Expenditures per enrollee exclude the following enrollees: territory program enrollees.
4. Expenditures do not include administrative expenditures or other non-benefit expenditures.
5. Notes on trends:
i. Expenditures increase faster in 2029 due to the expiration of legislatively mandated DSH cuts.
ii. Children and total enrollment increase faster in 2029 (and per enrollee expenditure growth grows slower) due to exhaustion of CHIP allotments, and
  children in M-CHIP programs become eligible for CHIP.
iii. Adult per enrollee expenditures increase sharply in 2019 due to adjustments in reported expenditures related to expansion and non-expansion adults.

              Prepared Statement of Hon. Chuck Grassley, 
                        a U.S. Senator From Iowa
    I appreciate Secretary Azar appearing before the committee to 
discuss President Trump's budget for fiscal year 2021. Secretary Azar 
oversees a sprawling department with programs that are crucial to the 
health and well-being of many Americans. The budget represents the 
administration's recommended funding for those programs, as well as its 
key policy proposals.

    While Congress decides funding levels and program changes, we have 
a duty to review the administration's budget proposal. Secretary Azar 
is here to help us in that regard. As with any budget submission, I 
disagree with a number of proposals. But I do want to speak to a few 
issues where it reflects my priorities.

    Ranking Member Wyden and I have made lowering prescription drug 
prices a top priority. President Trump's focus on the issue has been a 
game-changer. Secretary Azar has been the point person for the 
administration's efforts. The Secretary has also helped greatly with 
our legislative effort. He and his team have provided guidance and 
technical assistance as we developed and refined the bipartisan bill 
the committee reported out in July of last year.

    I am pleased that the budget calls on Congress to quickly pass a 
bipartisan bill and includes a prescription drug place-holder for $135 
billion in reduced taxpayer subsidies to drug companies. I will ask the 
Secretary to expand on this when we move to questions. For now, I will 
say that I look forward to continuing to work with the Secretary, the 
ranking member, and other Senators to provide relief to patients.

    The budget also contains a number of proposals to improve health 
care in rural communities. Ensuring access to health care in Iowa and 
other rural areas has long been a priority for me. Ranking Member Wyden 
and I continue to discuss how to help rural and other underserved 
areas. The administration's budget further bolsters our effort.

    I'd like to also take a moment to highlight an effort to help HHS 
be more effective in executing its mission. I understand that the HHS 
Office of National Security (ONS) is forging new ground with the 
intelligence community to leverage technology in innovative ways to 
better streamline intelligence operating procedures and to mitigate 
counterintelligence threats. I encourage the intelligence community to 
provide even broader access to ONS as it relates to its products and 
databases and to allow HHS to access vital information that it needs to 
mitigate threats to the Department, its funded partners, and its 
interagency colleagues.

    As you are aware, via my oversight efforts, I've worked to make 
sure that ONS receives access to certain intelligence community-related 
material and that it has gained access to some. However, more work 
needs to be done. Recently, I sent two classified letters to 
intelligence community components to help bridge the gap between ONS 
and its IC counterparts. As I've said before, the left hand and right 
hand must work together for the taxpayers.

    I will conclude by noting that HHS has many important challenges. 
Some are longstanding, like the high cost of prescription drugs. Others 
appear with little notice, such as the novel coronavirus. While there 
is sure to be disagreement on many items in the budget, the issues I 
have highlighted are a reminder that we can work together in a 
bipartisan way to get things done for the American people.

                                 ______
                                 
                 Prepared Statement of Hon. Ron Wyden, 
                       a U.S. Senator From Oregon
    President Trump's health-care agenda rips scores of new holes in 
the safety net that vulnerable Americans are sure to fall through. The 
textbook example is Medicaid. Right now, the administration is 
attempting to do on its own what it failed to do through the Congress: 
block-grant the Medicaid program.

    It's a policy the Finance Committee debated in this very room back 
in September 2017. It didn't make it out of the committee. It didn't 
get a vote on the floor. It didn't go anywhere--because it's a bad 
policy that hurts people.

    That said, the Trump administration doesn't seem to mind. It's 
trying to pull an administrative end-run around the Congress to push 
the dirty work of Medicaid block grants onto the States. You hear a 
whole lot of Washington lingo about ``flexibility.'' They even gave it 
a name that goes straight to the Orwellian Hall of Infamy: Healthy 
Adult Opportunity.

    Make no mistake: the Trump administration's proposal to block-grant 
Medicaid, led by CMS Administrator Seema Verma, would be the beginning 
of the end for the health-care safety net. It's not about flexibility, 
it's certainly not about opportunities for healthy adults--it's about 
draconian cuts. And it comes in addition to the other cuts the Trump 
administration has proposed for Medicaid. So let's talk about what 
slashing Medicaid really means for individual Americans.

    Medicaid pays for two out of three nursing home beds in this 
country. That's because in the United States, growing old is expensive. 
Before I was elected to Congress, I was the co-director of the Oregon 
Gray Panthers, a service organization for seniors. I spent a lot of 
time visiting with seniors in their homes, and the majority of them 
were folks who had to stretch every last penny to get by. So this issue 
goes way back for me.

    Even when people do everything right--when they scrimp and save 
over decades, when they skip vacations, when they live modestly and do 
every last thing they can to prepare for retirement--people still run 
out of money in old age. All it takes is one surprise illness or injury 
for the bills to accumulate. Or a family emergency. Or damage to a 
home. Savings dry up. It's a fact of life.

    And that's on top of all those who don't have savings--the millions 
and millions of people who go through their lives walking an economic 
tightrope. Nearly half of all American adults would struggle to come up 
with $400 in an emergency. That doesn't mean they have no right to see 
a doctor or get long-term care in old age.

    Protecting those people is what Medicaid and its nursing home 
guarantee is all about. Without that health-care safety net, what are 
seniors supposed to do when the savings dry up? How are nursing homes 
supposed to stay open without cutting their services down to 
frighteningly poor levels? How are low-income seniors who want to stay 
in their homes going to afford their health care?

    So when you hear all the talk about ``flexibility,'' ``innovative 
solutions,'' and ``holding States accountable,'' it's all a smokescreen 
for Medicaid cuts. The consequences are dangerous, and they are 
personal.

    The Trump administration has also gone to court to have the entire 
Affordable Care Act thrown out. Protections for pre-existing 
conditions--gone. Tax credits for health care--gone. Rules banning the 
worst insurance company abuses--gone. You're talking about tens of 
millions of people getting kicked off their health care.

    It would be devastating for people like Jasper. He's a young guy 
with a big heart and a lot of energy. But he was born with serious 
medical issues--cystic fibrosis, cardiac and pancreatic problems, 
hearing loss. He gets a lot of costly treatment, and his family relies 
on the Affordable Care Act for peace of mind that he will get the care 
he needs. Donald Trump has no backup plan for Jasper and his family if 
he successfully repeals the ACA.

    That didn't stop the President from saying during his State of the 
Union address that he had made an ``ironclad pledge'' to ``always 
protect patients with pre-existing conditions.'' Donald Trump protects 
pre-existing conditions like sea lions protect salmon on our mighty 
Columbia River. It's the kind of protection that comes with an uptick 
in the mortality rate.

    Let me turn to prescription drug prices. The President has held a 
whole lot of 
curtain-raising events for shiny new policies on prescription drugs. 
Let's recap a few. He was going to force Big Pharma to list drug prices 
on television ads--that policy was blocked. He's talked about requiring 
rebates to go directly to patients--didn't follow through. He was going 
to tie drug prices in the U.S. to drug prices abroad--still nothing. He 
had a policy to speed approval of generics--no apparent effect.

    So for all the Trump talk about drug prices over the last 3 years, 
patients are still getting mugged at the pharmacy counter. Drug prices 
are up again in 2020.

    The Finance Committee has worked hard on the prescription drug 
issue, as has the House. Chairman Grassley has been a good partner on 
this, and I hope that we can find a way to move all this good work 
forward.

    Bottom line, the President has been making promises about bringing 
down drug prices for 3 years, and he hasn't gotten it done.

                                 ______
                                 

                             Communications

                              ----------                              


                      American Academy of Audiology

                  11480 Commerce Park Drive, Suite 220

                            Reston, VA 20191

                       Contact: Susan Pilch, J.D.

The American Academy of Audiology appreciates the opportunity to 
provide these comments to the Committee as it seeks to gather 
information regarding the Administration's planned healthcare 
priorities from Health and Human Services Secretary Alex Azar. The 
Academy is the world's largest professional organization of, by and for 
audiologists. Representing the interests of approximately 14,000 
audiologists nationwide, the Academy is dedicated to providing quality 
hearing care services through professional development, education, 
research, and increased public awareness of hearing and balance 
disorders.

President's Budget Proposes Additional Five Percent Reduction to Non-
Primary Care/Services--Compounding Significant Reductions for Those 
Providers Planned for 2021

The Administration's budget proposal contemplates a monthly payment to 
providers who are eligible to bill for evaluation and management 
services (E/M) and who provide ongoing primary care to Medicare 
beneficiaries. To achieve budget neutrality, a five percent reduction 
to the valuations of all non-primary care services and procedures under 
the PFS would pay for these additional payments. While the Academy 
appreciates the importance of primary care services for Medicare 
beneficiaries, this five percent reduction would compound the already 
expected eight percent reduction contemplated for audiology in 2021. A 
combined thirteen percent reduction for audiology in Medicare would be 
unsustainable.

Expected 2021 Medicare Reimbursement Cuts to Providers that Do Not Bill 
E/M Codes Need Reevaluation to Ensure Equity Across Provider Types

In the 2020 Physician Fee Schedule (PFS) final rule, CMS accepted the 
AMA RUC recommendations for increased payment for the office/outpatient 
evaluation and management (E/M) codes. However, in an effort to 
maintain budget neutrality and offset the E/M increased payments, CMS 
also announced significant decreases in Medicare reimbursement in 2021 
that will directly impact providers with low utilization of E/M 
services and providers who do not bill office/outpatient E/M codes. 
Given the existing disparities between the actual reimbursement rates 
prior to the application of any reductions and the access or lack 
thereof to particular billing codes among different providers, the 
actual impact of the expected reductions will not be uniform across all 
providers.

Audiology-Specific Distinctions That Compound Planned Reimbursement 
Reductions

With respect to audiology, we would like to highlight some of the 
unique circumstances and distinctions that will compound the effect of 
the planned reimbursement reductions:

      Current regulations prohibit audiologists from billing Medicare 
for E/M codes.
      Audiologists are not permitted to use the new G codes for E/M 
services.
      Audiologists do not have any dedicated E/M codes at this time. 
In contrast, some other non-physician providers have created their own 
dedicated E/M codes.
      The AMA drafted a listing of E/M services performed by HCPAC 
providers. However, this listing only identified the word 
``evaluation'' in the code descriptor.
        Audiology codes identified are procedural services 
which have ``evaluation'' in the descriptor. This is an erroneous 
assumption as ``evaluation'' in these CPT codes defines cognitive work, 
not management.
        The closest approximation of audiology E/M codes 
may be based on payment for cognition within the RVU.

In light of the aforementioned considerations, the proposed 6% cut for 
budget neutrality and additional 2% sequestration cut will have a 
disproportionate effect on audiologists. Audiologists do not have 
access to E/M services to offset the expected 8% reimbursement 
reduction. We have concerns that these reductions will have an 
unfortunate impact on patient access to services and care. An 
additional 5% reimbursement reduction to audiologists, as proposed in 
the President's Budget, is untenable.

We have highlighted these concerns to CMS in hopes that the Agency will 
consider an alternate approach with respect to achieving budget 
neutrality to offset the E/M increases in a way that takes into account 
the inherent differences between provider types.

Improving Access to Hearing Healthcare in Rural Areas--the Medicare 
Audiology Access and Services Act of 2019 (H.R. 4056/S. 2446).

    The President's budget proposal lists improving access to rural 
healthcare as an overarching priority. To that end, untreated hearing 
loss is a significant concern in rural areas. Approximately 20% of the 
U.S. population reside in rural areas and adults within these areas 
represent a vulnerable population with barriers to accessing hearing 
healthcare.\1\ Untreated hearing loss can lead to depression, anxiety 
and social isolation and tends to be more prevalent in rural areas.\2\ 
In addition, hearing impairment prevalence is positively associated 
with poverty, reduced educational attainment, and manual labor 
occupations \3\--characteristics that are more prominent in rural 
communities.\4\ Untreated hearing loss also has profound implications 
to overall health and can impose significant financial burdens to the 
healthcare system. Individuals with even mild hearing loss are three 
times more likely to experience a fall and falls are the leading case 
of fatal injury for Americans over age 65.\5\ In addition, research is 
now emerging indicating that Seniors with hearing loss are more likely 
to develop cognitive decline up to 40% faster than those without 
hearing loss.\6\
---------------------------------------------------------------------------
    \1\ Chan S., Hixon B., Adkins M., Shinn J.B., and Bush M.L. (2017). 
Rurality and determinants of hearing healthcare in adult hearing aid 
recipients. The Laryngoscope, 127(10), 2362-2367.
    \2\ Brennan-Jones CG, et al. Self-reported hearing loss and manual 
audiometry: A rural versus urban comparison. Aust J Rural Health. 2015.
    \3\ Chou C., et al. Association of socioeconomic position with 
sensory impairment among U.S. working-aged adults. American Journal of 
Public Health. 2015;105(6):1262-1268.
    \4\ Chan S., Hixon B., Adkins M., Shinn J.B., and Bush M.L. (2017). 
Rurality and determinants of hearing healthcare in adult hearing aid 
recipients. The Laryngoscope, 127(10), 2362-2367.
    \5\ Centers for Disease Control and Prevention. (May 2018) Deaths 
from Falls Among Persons Aged 65 Years--United States, 2007-2016. 
https://www.cdc.gov/mmwr/volumes/67/wr/mm67
18a1.htm.
    \6\ Lin, Frank and Yaffe, Kristine. Journal of the American Medical 
Association: Hearing Loss and Cognitive Decline in Older Adults. 
(February 2013) https://jamanetwork.com/journals/jamainternalmedicine/
fullarticle/1558452.

Legislation has been introduced in both the House and Senate that would 
eliminate many of the current barriers to rural elderly patients being 
able to more efficiently access hearing healthcare. This legislation 
would reclassify audiologists under Medicare as ``practitioners,'' 
allow for direct access by Medicare patients to audiologists and allow 
---------------------------------------------------------------------------
audiologists to provide currently covered services beyond diagnostics.

Direct Access to Audiologist Services in Medicare Would Remove a 
Current Barrier to Rural Patient Screening and Treatment

Currently Medicare beneficiaries must first receive a physician 
referral to see an audiologist for hearing and balance diagnostic 
tests. The American Academy of Audiology strongly supports removing 
this barrier and favors giving beneficiaries the option to see either a 
physician or an audiologist first for hearing and balance-related 
health care. The Federal Employees Health Benefits Program (FEHBP), the 
Veterans Administration (VA) as well as many private health plans allow 
their enrollees direct access to audiologists without physician 
referral. The VA has had this policy in place since 1992. In a letter 
from VA Acting Deputy Under Secretary for Health, Michael Kussman, MD 
to Senator Grassley in 2004, he states that the VA direct access policy 
``provides high-quality, efficient and cost-effective hearing care.'' 
Dr. Kussman goes on to state that requiring all veterans with hearing 
loss complaints to see ENT physicians would result in unnecessary 
medical care, inefficient use of VA resources, and longer waits for 
veterans who need the specialized care of ENT physicians. ``The [direct 
access] policy is cost-effective because an unnecessary clinic visit is 
avoided.'' In addition, Dr. Kussman states that ``the VA has not 
experienced patient complaints or problems as a result of the direct 
access policy.''\7\
---------------------------------------------------------------------------
    \7\ https://www.audiology.org/sites/default/files/advocacy_files/
DeptofVeteranAffairs.pdf.

Rural Medicare beneficiaries in particular would benefit from being 
able to directly access the care of an audiologist. Given significant 
travel distances that exist in rural communities, removing an 
unnecessary physician visit would streamline access to care, provide 
needed interventions in a timely manner and save the patient and the 
---------------------------------------------------------------------------
Medicare program money.

The Department of Veterans Affairs Successfully Uses TeleAudiology to 
Reach Rural Patients; Medicare Should Follow Suit

Audiologists are currently classified as ``suppliers'' in Medicare and 
as such are not among the list of providers authorized to provide 
services via telehealth. However, if audiologists were to be 
reclassified as ``practitioners''--similar to how clinical 
psychologists and clinical social workers are classified in Medicare, 
they would be authorized to provide and be reimbursed for audiology 
services provided via telehealth.

As a model, the Department of Veteran Affairs has recognized that 
providing audiology services via telehealth is an effective way to 
reach rural veterans.\8\ ``Expanded use of innovative technology is 
increasing access points to hearing care in remote areas, enabling 
telehealth providers to expand their reach to patients and their 
families in satisfying and effective ways,'' said Chad Gladden, 
audiology telehealth coordinator for the Audiology and Speech Pathology 
National Program Office.\9\
---------------------------------------------------------------------------
    \8\ https://www.blogs.va.gov/VAntage/62446/audiology-telehealth-
helping-rural-veterans-access-hearing-evaluations/.
    \9\ https://www.blogs.va.gov/VAntage/62446/audiology-telehealth-
helping-rural-veterans-access-hearing-evaluations/.
---------------------------------------------------------------------------

Conclusion

The American Academy of Audiology appreciates this opportunity to 
provide our thoughts and suggestions on the President's 2021 budget 
proposal specifically as it relates to imminent Medicare reimbursement 
reductions for audiology, additional proposed reductions and ways in 
which to expand rural Medicare beneficiary access to hearing care 
services.

                                 ______
                                 
              American Speech-Language-Hearing Association

                        2200 Research Boulevard

                        Rockville, MD 20850-3289

                         [email protected]

                              301-296-5700

                         https://www.asha.org/

Chairman Grassley and Ranking Member Wyden: The American Speech-
Language-Hearing Association (ASHA) thanks you for the opportunity to 
submit this statement to the Committee on the President's Fiscal Year 
(FY) 2021 Budget. My name is Theresa H. Rodgers, MA, CCC-SLP, ASHA's 
President for 2020.

ASHA is the national professional, scientific, and credentialing 
association for 211,000 members and affiliates who are audiologists; 
speech-language pathologists; speech, language, and hearing scientists; 
audiology and speech-language pathology support personnel; and 
students.

Overview

Audiologists and speech-language pathologists (SLPs) are highly 
educated, trained, and certified health care professionals who are 
licensed in every state to provide diagnostic and treatment services. 
Audiologists and SLPs provide patient-centered care in the prevention, 
identification, diagnosis, and evidence-based treatment of hearing, 
balance, speech, language, cognitive-communication, and swallowing 
disorders in individuals of all ages. The dedicated individuals of both 
professions work tirelessly to help realize ASHA's vision of making 
effective communication, a human right, accessible and achievable for 
all.

ASHA members, including the more than 1,400 in Iowa and nearly 2,200 in 
Oregon, work in health care settings to help people learn, maintain, or 
improve skills and functional abilities that have not developed 
normally (habilitation), and to regain skills that have been impaired 
due to injury, illness, or condition(s) that have impacted normal 
functioning (rehabilitation).

Audiologists and SLPs provide services supporting the overall health 
and well-being of their patients to ensure that people of all ages--
especially older Americans--can properly manage and/or avoid costly 
conditions or impairments that could impact their ability to 
effectively communicate and result in costly post-acute care (PAC).

The President's FY 2021 Budget (Budget) request includes numerous 
provisions of interest and concern to ASHA that will impact the ability 
of audiologists and SLPs to provide essential hearing, balance, speech, 
language, and cognitive care, especially to individuals enrolled in 
Medicare and Medicaid. The following comments highlight several of 
these proposals and recommend improvements to ensure beneficiaries of 
these important programs have timely access to needed care provided by 
these licensed health care professionals.

Medicare

Medicare is the primary federal program seniors rely on for health 
care; therefore, ensuring that statute and regulations provide 
sufficient reimbursement and efficient administration to allow 
audiologists and SLPs to provide clinically appropriate care--at the 
proper time and in the right setting--is of paramount importance. ASHA 
is interested in the following Medicare proposals in the Budget and the 
impact on audiologists and SLPs to meet that mandate.
Lowering the Cost of Prescription Drugs
The budget includes an estimate of $135 billion in savings over 10 
years for enactment of comprehensive drug pricing reform. ASHA supports 
ensuring that Medicare beneficiaries have access to affordable 
prescription drugs and other benefits and services necessary to ensure 
their health and well-being. However, ASHA is disappointed that the 
budget proposal did not recommend reinvesting a portion of the savings 
from prescription drug reform to enhancing hearing benefits under the 
Medicare program.

ASHA supports Section 602 of H.R. 3, the Elijah E. Cummings Lower Drug 
Costs Now Act, which the House of Representatives passed on December 
12, 2019. Section 602 would enable audiologists to be reimbursed by 
Medicare for covered diagnostic and treatment services that they are 
licensed to provide and would reclassify audiologists as practitioners 
under Medicare giving seniors better access to hearing and balance care 
provided by audiologists. The provision also mandates a study to 
examine beneficiary direct access to audiologists and clarifies that 
the U.S. Secretary of Health and Human Services (HHS) has the authority 
to authorize audiologists to furnish services for reimbursement without 
requiring beneficiaries to first obtain a physician order.

These changes are necessary because Medicare precludes seniors from 
accessing the full range of services provided by audiologists in a 
timely manner by requiring a clinically unnecessary physician order and 
limiting reimbursement to diagnostic services, although audiologists' 
scope of practice includes auditory and vestibular treatment and 
neurological monitoring. Medicare currently covers these treatment 
services when furnished by clinicians, such as physicians or other 
nonphysician practitioners. In addition, most private health plans, 
Federal Employees Health Benefits (FEHB) Program plans, the U.S. 
Department of Veterans Affairs (VA), and some Medicare Advantage plans 
allow for direct access to audiology services, which is consistent with 
state laws.

The inability of most Medicare beneficiaries to receive both diagnostic 
and treatment services provided by an audiologist limits access to 
timely hearing health care and may increase health care costs. The 
National Academy of Sciences issued a report, ``Hearing Health Care for 
Adults: Priorities for Improving Access and Affordability,'' which 
recommends Medicare coverage of audiology treatment.\1\ In addition, 
research conducted by the Johns Hopkins Bloomberg School of Public 
Health has found that ``older adults with untreated hearing loss incur 
substantially higher total health care costs compared to those who 
don't have hearing loss-an average of 46%, totaling $22,434 per person 
over a decade.''\2\ Since individuals with mild hearing loss are three 
times more likely to experience a fall, and falls are the leading cause 
of fatal injury for Americans over 65, early diagnosis and timely 
treatment of hearing and balance impairments by audiologists helps 
older Americans avoid more serious and costly health care problems that 
undermine their quality of life. Seniors with hearing loss develop 
cognitive problems and experience cognitive decline up to 40% faster 
than those with normal hearing.\3\, \4\, \5\ 
Furthermore, untreated hearing loss leads to depression, anxiety, and 
social isolation.\6\
---------------------------------------------------------------------------
    \1\ National Academies of Sciences, Engineering, and Medicine. 
(2016). Hearing Health Care for Adults: Priorities for Improving Access 
and Affordability. Retrieved from http://nationalacademies.org/hmd/
reports/2016/Hearing-Health-Care-for-Adults.aspx.
    \2\ Reed, Nicholas S., et al. (2018). Trends in Healthcare Costs 
and Utilization Associated with Untreated Hearing Loss Over 10 Years. 
Retrieved from https://www.jhsph.edu/news/news-releases/2018/patients-
with-untreated-hearing-loss-incur-higher-health-care-costs-over-
time.html.
    \3\ Lin, Frank and Ferrucci, Luigi. (2012). Hearing Loss and Falls 
Among Older Adults in the United States. Retrieved from https://
www.ncbi.nim.nih.gov/pmc/articles/PMC3518403/.
    \4\ Centers for Disease Control and Prevention. (2018). Deaths from 
Falls Among Persons Aged 65 Years--United States, 2007-2016. Retrieved 
from https://www.cdc.gov/mmwr/volumes/67/wr/mm6718a1.htm.
    \5\ Lin, Frank and Yaffe, Kristine. (2013). Journal of the American 
Medical Association: Hearing Loss and Cognitive Decline in Older 
Adults. Retrieved from https://jamanetwork.com/journals/
jamainternalmedicine/fullarticle/1558452.
    \6\ Oxford Academic. (2012). Hearing-impaired adults are at 
increased risk of experiencing emotional distress and social engagement 
restrictions five years later. Retrieved from https://academic.oup.com/
ageing/article/41/5/618/47025/Hearing-impaired-adults-are-at-increased-
risk-of.

To address these deficiencies, ASHA has endorsed bipartisan 
legislation, S. 2446, the Medicare Audiologist Access and Services Act, 
introduced by Senators Elizabeth Warren and Rand Paul, along with 
Senators Roger Wicker and Sherrod Brown. S. 2446 addresses this issue 
by enabling audiologists to provide both diagnostic and treatment 
services; thereby, allowing beneficiaries direct access to audiologists 
without a physician order, and reclassifying audiologists as 
practitioners under Medicare, which would allow these licensed health 
---------------------------------------------------------------------------
care professionals to provide telehealth services.

ASHA encourages the Committee to include provisions from S. 2446 in any 
prescription drug bill advanced in the Senate and/or reconciled with 
H.R. 3. Reinvesting a portion of savings from enactment of 
comprehensive drug pricing reform in new hearing benefits under 
Medicare will improve hearing and balance care for America's seniors 
while lowering health care costs resulting from injuries sustained as a 
result of untreated hearing and balance related falls.
Expand and Enhance Access to Medicare Telehealth Services
The Budget proposes several budget neutral provisions to expand and 
enhance access to telehealth services under Medicare. ASHA appreciates 
Executive Order 13813, ``Protecting and Improving Medicare for Our 
Nation's Seniors'' and supports corresponding efforts to enhance access 
to Medicare-covered services through telehealth.

Medicare does not reimburse audiologists or SLPs for telehealth 
services. However, both audiologists and SLPs are qualified providers 
of telehealth services and provide such services under many state laws 
and other payer policies, including Medicaid. Twenty states have 
included provisions in licensure laws that specifically authorize 
audiologists and SLPs to perform services via telehealth.\7\ Private 
insurers in 30 states have established policies that allow audiologists 
and SLPs to provide services via telehealth.\8\ In addition, 27 state 
Medicaid programs authorize these clinicians to perform services via 
telehealth.\9\
---------------------------------------------------------------------------
    \7\ American Speech-Language-Hearing Association. (n.d.). Licensure 
Board Telepractice Requirements: Audiology and Speech-Language 
Pathology. Retrieved from https://www.asha.org/uploadedFiles/
Telepractice-Requirements-and-Reimbursement.pdf.
    \8\ American Speech-Language-Hearing Association. (n.d.). Private 
Insurance Laws and Regulations: Telepractice Reimbursement, Audiology 
and Speech-Language Pathology. Retrieved from https://www.asha.org/
uploadedFiles/Telepractice-Requirements-and-Reimbursement.pdf.
    \9\ American Speech-Language-Hearing Association. (n.d.). Medicaid 
Laws and Regulations: Telepractice Reimbursement, Audiology and Speech-
Language Pathology. Retrieved from https://www.asha.org/uploadedFiles/
Telepractice-Requirements-and-Reimbursement.pdf.

A growing body of research on the use of telepractice for communication 
disorders includes many studies demonstrating the comparability of 
telepractice and in-person services. For example, research conducted by 
the VA indicates that audiology services provided via telehealth are 
comparable to in-person delivery of care, while published studies also 
indicate that speech-language pathology services provided via 
telehealth are as effective as services provided in 
person.\10\, \11\, \12\
---------------------------------------------------------------------------
    \10\ Gladden, Chad. (2013). The Current Status of VA Audiology. 
Retrieved from https://www.ncrar.research.va.gov/Education/Conf_2013/
Documents/Gladden.pdf.
    \11\ Hayman M., Skinner L., and Wales D. (2017). The Efficacy of 
Telehealth-Delivered Speech and Language Intervention for Primary 
School-Age Children: A Systematic Review. Retrieved from https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC5546562/.
    \12\ Alvares, Robin, Grogan-Johnson, Sue, and Rowan, Lynne. (2010). 
A pilot study comparing the effectiveness of speech language therapy 
provided by telemedicine with conventional on-site therapy. Retrieved 
from https://journals.sagepub.com/doi/abs/10.1258/jtt.2009.090608.

ASHA supports enabling audiologists and SLPs to provide telehealth 
services to Medicare beneficiaries when clinically appropriate and the 
ability of the clinician to ensure that the quality of any services 
provided via telehealth matches the quality of services provided in-
person. Medicare coverage of audiology and speech-language pathology 
services would increase outlays by less than $2.5 million over five 
years and less than $10 million over 10 years.\13\
---------------------------------------------------------------------------
    \13\ Quantria Strategies. (2015). ASHA Telehealth Cost Study. 
Analysis of a Proposal to Extend Telehealth to Audiology and Speech-
Language Pathology Services. P. 3-4.

ASHA supports bipartisan legislation, S. 2741, the Creating 
Opportunities Now for Necessary and Effective Care Technologies 
(CONNECT) for Health Act of 2019, introduced by Senators Brian Schatz, 
along with Senators Roger Wicker, Ben Cardin, John Thune, Mark Warner 
and Cindy Hyde-Smith, co-chairs of the Senate Telehealth Caucus, among 
others. The bill, which has 33 bipartisan cosponsors and was referred 
to the Finance Committee, eliminates several barriers in Medicare that 
inhibit the ability of licensed health care professionals to provide 
---------------------------------------------------------------------------
telehealth services.

Of specific interest to ASHA, Section 3 of S. 2741 authorizes the HHS 
Secretary to waive certain restrictions on telehealth services, 
including those related to the types of providers who can provide 
telehealth services. In addition, Section 14 would permit demonstration 
programs that could allow audiologists and SLPs--and other licensed 
health care professionals--to provide telehealth services to Medicare 
beneficiaries.

ASHA encourages the Committee to consider S. 2741 and/or include these 
low to minimal cost provisions in any health-related legislation the 
Committee may consider this year.
Reprioritize Primary and Preventive Care in Medicare
The Budget proposes a budget neutral provision to create a risk-
adjusted monthly ``Medicare Priority Care'' payment for providers who 
are eligible to bill for outpatient evaluation and management (E/M) 
services and who provide ongoing primary care to Medicare 
beneficiaries. The proposal follows the release of the 2020 Medicare 
Physician Fee Schedule (MPFS) final rule, issued on November 15, 2019, 
in which the Centers for Medicare and Medicaid Services (CMS) proposed 
to increase reimbursement for office/outpatient E/M codes for 2021.

Unfortunately, CMS proposed steep and seemingly arbitrary reductions to 
services furnished by other physician and nonphysician professionals to 
ensure the budget neutrality of the MPFS as required by statute. CMS 
acknowledged the ``magnitude of redistributive adjustment necessary to, 
budget neutralize the increased values,'' while noting that future 
rulemaking would address the issue. The Budget proposal notes that a 5% 
annual reduction to the valuation of all non-primary care services and 
procedures, as determined by the Secretary under the MPFS, will achieve 
budget neutrality of the proposal.

ASHA supports coding and payment changes to office/outpatient E/M 
services and recognizes that CMS must meet statutory requirements to 
maintain budget neutrality by offsetting the E/M payment increases. 
However, ASHA is extremely concerned about the significant negative 
financial impact the budget neutrality requirement will have for many 
specialties--including audiology and speech-language pathology--that 
cannot report E/M services as part of their Medicare benefit category 
to help potentially offset the projected reductions in 2021.

On February 5, 2020, Representatives Buddy Carter and Lisa Blunt 
Rochester sent a letter to CMS that was signed by 99 members of the 
House of Representatives requesting additional information about the 
process CMS used to reduce the reimbursement for services furnished by 
the 37 specialty providers that would be negatively impacted by the 
proposed rule. On February 10, 2020, a group of 13 organizations 
representing providers of specialty services, including ASHA, submitted 
comments to CMS ahead of the publication of the FY 2021 proposed rule 
and recommended several alternative options for mitigating the proposed 
reductions.

However, as evidenced by the Budget proposal, CMS will likely note in 
its FY 2021 proposed rule that it lacks sufficient regulatory authority 
to fully address the fee schedule's budget neutrality requirement 
absent legislative intervention. Therefore, ASHA encourages the 
Committee to engage with CMS to better understand the impact such cuts 
would have on seniors' access to medically necessary services and 
explore legislative alternatives that could mitigate the negative 
impact of such reductions on audiologists, SLPs, and other specialty 
service providers.
Address Excessive Payment for Post-Acute Care Providers by Establishing 
        a Unified Payment System Based on Patients' Clinical Needs 
        Rather than Site of Care
The Budget proposes to reduce annual payment updates for skilled 
nursing facilities (SNFs), home health agencies, and inpatient 
rehabilitation facilities from FY 2021 to FY 2025, and institute a 
budget neutral unified payment system that would span all four PAC 
settings, including long-term care hospitals, with payments based on 
episodes of care and patient characteristics rather than the site of 
service. The proposal also would require a unified quality reporting 
program across all four settings.

As part of the effort to ensure program integrity across PAC settings, 
CMS implemented the new prospective payment system for SNFs, the 
Patient-Driven Payment Model (PDPM), on October 1, 2019. PDPM bases 
payment on patient characteristics rather than on the type and volume 
of services provided. CMS developed PDPM to address concerns of therapy 
overutilization to maximize reimbursement rather than meet patient 
needs under the previous payment system. CMS implemented a similar 
program known as the Patient-Driven Groupings Model (PDGM) for home 
health settings on January 1, 2020.

ASHA supports improving payment accuracy by basing payments on 
individual patient characteristics rather than service volume. However, 
we are monitoring the impact of PDPM implementation to ensure Medicare 
beneficiaries in SNFs continue to receive clinically appropriate 
therapy services provided by SLPs.

ASHA is troubled by reports from its members--and those from other 
therapy professions--about staffing reductions and changes in terms of 
employment that were attributed to the new payment model. SLPs have 
also shared that they were told the system requires group and 
concurrent therapy, establishes productivity requirements, and 
specifies which therapy professionals may provide care based on payment 
categories. None of these actions have basis in statute or regulation.

ASHA encourages the Committee to monitor ongoing implementation of PDPM 
and to request relevant CMS data to determine PDPM's and PDGM's impact 
on utilization relative to the previous payment model. Data on outcomes 
and quality improvement, hospital readmission rates, falls, and 
avoidable health conditions would be useful to determine the impact of 
PDPM implementation on Medicare beneficiaries' access to clinically 
appropriate care.

Medicaid

The Budget assumes a net savings to Medicaid of $920 billion over the 
next decade, which is realized through ``reforms'' designed to 
transform Medicaid financing. Unfortunately, the Budget assumes 
significant savings from several proposals focused on reducing Medicaid 
expenditures, rather than enhancing services or ensuring more robust 
provider networks. ASHA is especially interested in the following 
Medicaid proposal in the Budget and its impact on audiologists and SLPs 
to provide services to Medicaid beneficiaries.
Implement Medicaid Community Engagement Requirement
The Budget proposes to require certain Medicaid recipients to find 
employment, participate in work training programs, or volunteer at 
least 20 hours per week to receive statutorily mandated benefits.

This specific proposal is expected to reduce Medicaid spending by $152 
billion over the next decade, according to Budget documents.

CMS has also issued guidance to state Medicaid directors that allows 
states to shift some Medicaid program funding to block grants. Under 
the guidance, which CMS refers to as the Healthy Adult Opportunity 
program, the federal government would provide a set amount of funding 
to states for their Medicaid program and allow states to determine how 
the funding is used for different coverage groups. States could 
institute additional conditions of eligibility, such as work 
requirements, without federal approval.

Several states have implemented work requirements as a condition for 
enrolling in Medicaid. However, inappropriate application of these 
administrative requirements can result in wrongful termination from the 
program forcing reapplication, avoidable gaps in coverage, and delayed 
or denied medically necessary treatment. Imposing work requirements can 
significantly harm children, elderly, and individuals with 
disabilities, particularly for vulnerable individuals who cannot meet 
those requirements due to underlying health conditions, disabilities, 
or other functional impairments.

The administrative costs of monitoring and enforcing work requirements 
may undermine the financial savings theoretically realized by reducing 
enrollment and restricting access to health care coverage for those 
with medically necessary needs. In addition, determining whether HHS 
has authority to condition Medicaid coverage on compliance with work 
requirements without congressional authorization is the subject of 
ongoing judicial review. For example, on February 14, 2020, a three-
judge panel of the U.S. Court of Appeals for the District of Columbia 
Circuit unanimously agreed that the Secretary's authorization was 
indeed unlawful.\14\
---------------------------------------------------------------------------
    \14\ Gresham, et al. v. Azar et al., No. 19-5094 (D.C. Cir. 2020). 
Retrieved from https://www.courtlistener.com/pdf/2020/02/14/
charles_gresham_v._alex_azar_ii.pdf.

ASHA is opposed to substantial reductions in Medicaid funding and to 
requiring program participants (especially children, the elderly, and 
those with disabilities) to comply with so-called community engagement 
requirements, both of which are solely designed to reduce program 
expenditures and not to improve the health and well-being of those who 
rely on this important social safety net program. ASHA recommends that 
the Committee carefully consider how work requirements for Medicaid 
eligibility impact access to medically necessary care for low income 
---------------------------------------------------------------------------
American citizens in need of health care coverage.

If work requirements remain in place or are expanded, ASHA recommends 
that Congress require CMS to establish standards that avoid 
disenrollment of individuals without access to other health insurance 
coverage and ensure that the burden imposed on Medicaid beneficiaries 
and state Medicaid agencies for monitoring and enforcing work 
requirements do not ultimately reduce the availability of federal and 
state funds for providing medically necessary care to enrolled Medicaid 
beneficiaries.

Conclusion

ASHA encourages the Committee to consider with care the impact of the 
Budget proposal on the ability of those who rely on Medicare and 
Medicaid to access necessary health care services mandated by law, 
especially the hearing and balance care provided by audiologists and 
the speech, language, swallowing, and cognitive care provided by SLPs.

Thank you for the opportunity to provide this statement for the record. 
ASHA appreciates the Committee's examination of the Budget and looks 
forward to working with the Committee to ensure audiologists and SLPs 
can provide timely, quality, and clinically appropriate services to 
individuals throughout their lifespan in the proper setting as 
efficiently and cost effectively as possible. For more information, 
contact Jerry White, ASHA's director of federal affairs, health care, 
at [email protected].

                                 ______
                                 
                        Center for Fiscal Equity

                      14448 Parkvale Road, Suite 6

                          Rockville, MD 20853

                      [email protected]

                    Statement of Michael G. Bindner

Chairman Grassley and Ranking Member Wyden, thank you for the 
opportunity to submit these comments for the record to the Committee on 
Finance on the HHS FY 2021 Budget Request.

As we all know, the appropriations process for the next fiscal year 
takes place within the context of the Bipartisan Budget Act of 2019. In 
an election year, staying within the current parameters is the best 
course. Early passage makes transition easier for the next 
administration and Senate, regardless of electoral outcomes. Even if 
the President is reelected, staff turnover is to be expected in the 
Administration and the Committee. If changes are to be made due to 
changes in party, enactment before the election can always be 
supplemented with new legislation.

Health Insurance Reform is likely off the table, although a single-
payer plan is inevitable, as we discuss in Attachment One. Until then, 
the status of the Affordable Care Act is still at issue. The 
Administration believes that the Act is failing. It was not, but it 
will soon with the end of mandates. Rates will soon start going up as 
incentives for the uninsured are not adequate in the light of pre-
existing condition reform to make them less risk averse than investors 
in the private insurance market, the whole house of cards may 
collapse--leading to either single payer or the enactment of a 
subsidized public option (which, given the nature of capitalism, will 
evolve into single payer). While no one knows how the uninsured will 
react overtime, the investment markets will likely go south at the 
first sign of trouble.

It is likely that the Administration will have to deal with these 
issues next fiscal year, so whatever is budgeted for analytical support 
in the Department should likely be doubled. This is especially the case 
if a single-payer plan is sought by a new Administration. Please see 
Attachment One to see our previously submitted options for such a plan. 
The key to enacting any reform is funding, likely through tax reform 
Attachment Two discusses our most up to date treatment of this issue. 
The possibility of Wealth Taxes is discussed in Attachment Three. They 
are not a feasible option.

Retirement security for seniors and the disabled must always be 
addressed. 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 on the rich enacted 
by President Reagan, the Senate and just enough conservative Democrats 
in the House to do damage. They also gave us the ill-advised 1986 tax 
reform.

Now that the wealthy have to pay what they owe to the trust fund (or 
rather, the children of the wealthy of the 1980s), people are talking 
about means testing Social Security and were talking about making it 
attractive to upper classes by investing it. The latter non-sense 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.

Attachment One--Single-Payer, June 12, 2019

There is no logic in rewarding people with good genes and punishing 
those who were not so lucky (which, I suspect, is most of us). Nor is 
there logic in giving health insurance companies a subsidy in finding 
the healthy and denying coverage for the sick, except the logic of the 
bottom line. Another term for this is piracy. Insurance companies, on 
their own, resist community rating and voters resist mandates--
especially the young and the lucky. As recent reforms are inadequate 
(aside from the fact of higher deductibles and the exclusion of 
undocumented workers), some form of single-payer is inevitable. There 
are three methods to get to single-payer.

The first is 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.

The second option is Medicare for All, which I described in an 
attachment to yesterday's testimony and previously in hearings held May 
8, 2019 (Finance) and May 8, 2018 (Ways and Means). Medicare for All is 
essentially Medicaid for All without the smell of welfare and with 
providers reimbursed at Medicare levels, with the difference funded by 
tax revenue.

Medicare for All is a really good slogan, at least to mobilize the 
base. One would think it would attract the support of even the Tea 
Partiers who held up signs saying ``Don't let the government touch my 
Medicare!'' Alas, it has not. This has been a conversation on the left 
and it has not gotten beyond shouting slogans either. We need to decide 
what we want and whether it really is Medicare for All. If we want to 
go to any doctor we wish, pay nothing and have no premiums, then that 
is not Medicare.

There are essentially two Medicares, a high option and a low one. One 
option has Part A at no cost (funded by the Hospital Insurance Payroll 
Tax and part of Obamacare's high unearned income tax as well as the 
general fund), Medicare Part B, with a 20% copay and a $135 per month 
premium and Medicare Part D, which has both premiums and copays and is 
run through private providers. Parts A and B also are contracted out to 
insurance companies for case management. Much of this is now managed 
care, as is Medicare Advantage (Part C).

Obamacare has premiums with income-based supports and copays. It may 
have a high option, like the Federal Employee Health Benefits Program 
(which also covers Congress) on which it is modeled, a standard option 
that puts you into an HMO. The HMO drug copays for Obamacare are higher 
than for Medicare Part C, but the office visit prices are exactly the 
same.

What does it mean, then, to want Medicare for All? If it means we want 
everyone who can afford it to get Medicare Advantage Coverage, we 
already have that. It is Obamacare. The reality is that Senator Sanders 
wants to reduce Medicare copays and premiums to Medicaid levels and 
then slowly reduce eligibility levels until everyone is covered. Of 
course, this will still likely give us HMO coverage for everyone except 
the very rich, unless he adds a high-option PPO or reimbursable plan.

Either Medicare for All or a real single payer would require a very 
large payroll tax (and would eliminate the HI tax) or an employer paid 
subtraction value added tax (so it would not appear on receipts nor 
would it be zero rated at the border, since there would be no evading 
it), which we discus s below, because the Health Care Reform debate is 
ultimately a tax reform debate. Too much money is at stake for it to be 
otherwise, although we may do just as well to call Obamacare Medicare 
for All.

The third option is an exclusion for employers, especially employee-
owned and cooperative firms, who provide medical care directly to their 
employees without third party insurance, with the employer making HMO-
like arrangements with local hospitals and medical practices for 
inpatient and specialist care.

Employer-based taxes, such as a subtraction VAT or payroll tax, will 
provide an incentive to avoid these taxes by providing such care. 
Employers who fund catastrophic care or operate nursing care facilities 
would get an even higher benefit, with the proviso that any care so 
provided be superior to the care available through Medicaid or Medicare 
for All. Making employers responsible for most costs and for all cost 
savings allows them to use some market power to get lower rates.

This proposal is probably the most promising way to arrest health care 
costs from their current upward spiral--as employers who would be 
financially responsible for this care through taxes would have a real 
incentive to limit spending in a way that individual taxpayers simply 
do not have the means or incentive to exercise. The 
employee-ownership must ultimately expand to most of the economy as an 
alternative to capitalism, which is also unstable as income 
concentration becomes obvious to all.

The key to any single-payer option is securing a funding stream. While 
payroll taxes are the standard suggestion, there are problems with 
progressivity if such taxes are capped and because profit remains 
untaxed, which requires the difference be subsidized through higher 
income taxes. For this reason, funding should come through some form of 
value-added tax.

Timelines are also concerns. Medicare for All be done gradually by 
expanding the pool of beneficiaries, regardless of condition. Relying 
on a Public Option will first serve the poorest and the sickest, but 
with the expectation that private insurance will enlarge the pool of 
those not covered until the remainder can safely be incorporated into a 
single-payer system through legislation or bankruptcy.

Attachment Two--Tax Reform, Center for Fiscal Equity, November 13, 2019

Individual payroll taxes. These are optional taxes for Old-Age and 
Survivors Insurance after age 60 (or 62). We say optional because the 
collection of these taxes occurs if an income sensitive retirement 
income is deemed necessary for program acceptance. Higher incomes for 
most seniors would result if an employer contribution funded by the 
Subtraction VAT described below were credited on an equal dollar basis 
to all workers. If retained, the ceiling should be lowered to $75,000 
to reduce benefits paid to wealthier individuals and a floor should be 
established so that Earned Income Tax Credits are no longer needed. 
Subsidies for single workers should be abandoned in favor of radically 
higher minimum wages.

Income Surtaxes. Individual income taxes on salaries, which exclude 
business taxes, above an individual standard deduction of $75,000 per 
year, will range from 6% to 36%. This tax will fund net interest on the 
debt (which will no longer be rolled over into new borrowing), 
redemption of the Social Security Trust Fund, strategic, sea and non-
continental U.S. military deployments, veterans' health benefits as the 
result of battlefield injuries, including mental health and addiction 
and eventual debt reduction. Transferring OASDI employer funding from 
existing payroll taxes would increase the rate but would allow it to 
decline over time. So would peace.

Asset Value-Added Tax (A-VAT). A replacement for capital gains taxes, 
dividend taxes, and the estate tax. It will apply to asset sales, 
dividend distributions, exercised options, rental income, inherited and 
gifted assets and the profits from short sales. Tax payments for option 
exercises and inherited assets will be reset, with prior tax payments 
for that asset eliminated so that the seller gets no benefit from them. 
In this perspective, it is the owner's increase in value that is taxed. 
As with any sale of liquid or real assets, sales to a qualified broad-
based Employee Stock Ownership Plan will be tax free. These taxes will 
fund the same spending items as income or S-VAT surtaxes. This tax will 
end Tax Gap issues owed by high income individuals. A 24% rate is 
between the GOP 20% rate and the Democratic 28% rate. It's time to quit 
playing football with tax rates to attract side bets.

Subtraction Value-Added Tax (S-VAT). These are employer paid Net 
Business Receipts Taxes that allow multiple rates for higher incomes, 
rather than collection of income surtaxes. They are also used as a 
vehicle for tax expenditures including healthcare (if a private 
coverage option is maintained), veterans' health care for non-
battlefield injuries, educational costs borne by employers in lieu of 
taxes as either contributors, for employee children or for workers 
(including ESL and remedial skills) and an expanded child tax credit.

The last allows ending state administered subsidy programs and 
discourages abortions, and as such enactment must be scored as a must 
pass in voting rankings by pro-life organizations (and feminist 
organizations as well). An inflation adjustable credit should reflect 
the cost of raising a child through the completion of junior college or 
technical training. To assure child subsidies are distributed, S-VAT 
will not be border adjustable.

The S-VAT is also used for personal accounts in Social Security, 
provided that these accounts are insured through an insurance fund for 
all such accounts, that accounts go toward employee ownership rather 
than for a subsidy for the investment industry. Both employers and 
employees must consent to a shift to these accounts, which will occur 
if corporate democracy in existing ESOPs is given a thorough test. So 
far it has not.

S-VAT funded retirement accounts will be equal dollar credited for 
every worker. They also has the advantage of drawing on both payroll 
and profit, making it less regressive.

A multi-tier S-VAT could replace income surtaxes in the same range. 
Some will use corporations to avoid these taxes, but that corporation 
would then pay all invoice and subtraction VAT payments (which would 
distribute tax benefits. Distributions from such corporations will be 
considered salary, not dividends.

Invoice Value-Added Tax (I-VAT). Border adjustable taxes will appear on 
purchase invoices. The rate varies according to what is being financed. 
If Medicare for All does not contain offsets for employers who fund 
their own medical personnel or for personal retirement accounts, both 
of which would otherwise be funded by an S-VAT, then they would be 
funded by the I-VAT to take advantage of border adjustability. I-VAT 
also forces everyone, from the working poor to the beneficiaries of 
inherited wealth, to pay taxes and share in the cost of government. 
Enactment of both the A-VAT and I-VAT ends the need for capital gains 
and inheritance taxes (apart from any initial payout). This tax would 
take care of the low income Tax Gap.

I-VAT will fund domestic discretionary spending, equal dollar employer 
OASI contributions, and non-nuclear, non-deployed military spending, 
possibly on a regional basis. Regional I-VAT would both require a 
constitutional amendment to change the requirement that all excises be 
national and to discourage unnecessary spending, especially when 
allocated for electoral reasons rather than program needs. The latter 
could also be funded by the asset VAT (decreasing the rate by from 
19.5% to 13%).

As part of enactment, gross wages will be reduced to take into account 
the shift to S-VAT and I VAT, however net income will be increased by 
the same percentage as the I-VAT. Adoption of S VAT and I-VAT will 
replace pass-through and proprietary business and corporate income 
taxes.

Carbon Value-Added Tax (C-VAT). A Carbon tax with receipt visibility, 
which allows comparison shopping based on carbon content, even if it 
means a more expensive item with lower carbon is purchased. C-VAT would 
also replace fuel taxes. It will fund transportation costs, including 
mass transit, and research into alternative fuels (including fusion). 
This tax would not be border adjustable.

Attachment Three--Wealth Taxes

Senators Warren and Sanders have proposed wealth taxes to get our 
financial house in order. As expected, wealthy donors are not liking 
the idea of a wealth tax, nor are those who felt that President Trump 
will still be in office by election day. They under estimate the desire 
by Senate Republicans for self-preservation. Even without Trump on the 
ballot, 2020 is more like 1974 than 1984.

The bigger danger to enacting a wealth tax us that, even though Senator 
Warren is taking only small dollar donations, congressional candidates 
have no such qualms.

Wealthy taxpayers must want to pay more or they will stop higher taxes 
cold. They won't pay more to fund a higher child tax credit, a Green 
New Deal or Medicare for All.

Senator Warren is getting a raw deal on Medicare for All. Her funding 
solution was meant to fund the Sanders proposal. Critics are decrying 
her plan for being less specific, but the reality is that her plan 
dovetails off of his bill. Her proposal is an attempt to add meat to 
the revenue side, which Senator Sanders leaves open.

Broad based social services must be funded by a broad-based tax, such 
as our proposed subtraction VAT in Attachment Two. The reason that the 
Affordable Care Act came under attack was not objections to mandates 
(which is a creature of the Heritage Foundation proposal), but because 
it was funded by a payroll surtax on unearned income from dividends and 
capital gains from taxpayers in the top 2% of filers.

High income investors exercise monopsony power over their workers, it 
is likely that everyone shared the pain. A broad-based consumption tax 
would be an easier sell (were it not for President Obama's promise not 
to increase taxes on the bottom 98%). The cynical view us that Obama 
knew that attacks in ACA funding would make the Republicans demonstrate 
their fealty for the rich. If so, this stunt cost his party the 
Congress.

A wealth tax can be considered an ex post facto income tax, also making 
it unconstitutional. It could be established by constitutional 
amendment, but it would be far easier to create salary surtax 
prepayment bonds. This plays to why the wealthy would want to pay more 
and would save us a bundle on net interest payments.

Getting the wealthy on board is essential to reform. Social Security 
was passed because FDR played Wall Street against the threat if 
socialism. It is now time to fund socialism by helping Wall Street get 
out if the debt bomb it has created for itself.

                                 ______
                                 
                Health Industry Distributors Association

                         310 Montgomery Street

                       Alexandria, VA 22314-1516

                         Phone: (703) 549-4432

                          Fax: (703) 549-6495

                         https://www.hida.org/

The Honorable Chuck Grassley
Chairman
U.S. Senate
Committee on Finance
104 Hart Senate Office Building
Washington, DC 20510

The Honorable Ron Wyden
Ranking Member
U.S. Senate
Committee on Finance
221 Dirksen Senate Office Building
Washington, DC 20510

Dear Chairman Grassley and Ranking Member Wyden:

We are writing to express our support for full funding for the Public 
Health and Social Services Emergency Fund as part of the Fiscal Year 
2021 Labor, Health and Human Services, Education, and Related Agencies 
bill. As the funding source for the Assistant Secretary of Preparedness 
and Response (ASPR), full funding is necessary to fully equip our 
country to prepare for and respond to global pandemics such as the 
Coronavirus. These funding levels are vital to ensuring the U.S. is 
prepared for the next global pandemic. Additionally, the Section 301 
tariffs currently in place on certain medical product imports from 
China prevent our country from being fully prepared to address current 
and future public health challenges.

The reauthorization legislation included in the Pandemic and All-
Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAI), 
addressed for the first time, specific language regarding the security 
and capabilities of the healthcare supply chain. In order to ensure an 
elastic supply chain, capable of responding to all manners of public 
health emergencies including natural disasters, biological events, and 
pandemic diseases, adequate funding needs to be provided for the ASPR. 
Funding for these programs will help to strengthen public and private 
partnerships, as mandated by PAHPAI, before, during, and after public 
health emergencies. The provisions in PAHPAI supporting this initiative 
include:

      Sec. 302(a)
      Sec. 302(b)
      Sec. 403(a)(l)(B)(i)(II)
      Sec. 403(a)(4)(E)
      Sec. 319C-3(b)(1)(A)(ii)

Medical products are critical to any emergency or pandemic response. 
Just this year, our country was faced with a particularly severe 
influenza season while also managing the emerging Novel Coronavirus 
(COVID-19). These simultaneous events have placed a substantial 
increase in demand for vital supplies such as gloves and gowns which 
are essential to protecting the American people.

While coronavirus has been well contained domestically, the healthcare 
supply chain relies heavily on shipping containers from China to 
deliver safe, affordable and timely product to U.S. shores. As the 
world responds to coronavirus, it has become clear that the U.S. cannot 
rely so heavily on one foreign entity to meet its demand for healthcare 
supplies. It is essential that Congress fully fund programs, identified 
under PAHPAI, which support the partnership of government agencies with 
industry working toward the development of a domestic cushion of 
essential medical supplies as well as the diversification of their 
means of production.

Furthermore, the Section 301 tariffs on medical products such as gloves 
and gowns hinder our country's ability to fully prepare for and respond 
to global pandemics. Products such as gloves and gowns are essential to 
protect the American people as they prevent infection as medical 
professionals respond to infectious diseases such as flu and the 
Coronavirus, manmade terrorist incidents with biological pathogens, 
natural disaster responses such as hurricanes, earthquakes, and fires, 
and thousands of medical procedures every day. We have seen a 
substantial increase in demand for these supplies during infectious 
outbreaks, including the 2014 Ebola outbreak and the 2009 HIN1 
epidemic, and we are seeing similar increases during the current 
Coronavirus event.

Adequate funding for the Agencies responsible for preparing for and 
responding to public health emergencies is vital to ensuring our 
country is prepared to respond to the next coronavirus, Ebola, or SARS. 
As such, we strongly urge you to support full funding for the Assistant 
Secretary of Preparedness and Response as part of the Fiscal Year 2021 
Labor, Health and Human Services, Education, and Related Agencies bill. 
Furthermore, we appreciate your attention to the issue of Section 301 
tariffs as applicable to imported health product and their impact on 
the U.S. response to coronavirus. Your continued support helps ensure 
the availability of safe and affordable healthcare products during 
pandemics and other public health events.

Sincerely,

Linda Rouse O'Neill
Vice President, Government Affairs
Health Industry Distributors Association


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