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



 
  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2021

                              ----------                              


                       TUESDAY, FEBRUARY 25, 2020

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 10:34 a.m. in room SD-124, Dirksen 
Senate Office Building, Hon. Roy Blunt (chairman) presiding.
    Present: Senators Blunt, Shelby, Alexander, Kennedy, Hyde-
Smith, Rubio, Murray, Durbin, Shaheen, Merkley, Schatz, 
Baldwin, Murphy, and Leahy.


                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                        Office of the Secretary

STATEMENT OF HON. ALEX AZAR, SECRETARY


                 opening statement of senator roy blunt


    Senator Blunt. The Appropriations Subcommittee on Labor, 
Health and Human Services, Education, and Related Agencies will 
come to order.
    Thank you, Secretary Azar, for being here. It has turned 
out to be a more eventful day and week than we might have 
anticipated when we set this hearing up. But we are grateful 
that you have shown up as we asked you to at the time we asked 
you to.
    The budget you suggested requests many of the same kinds of 
cuts that occurred in fiscal year 2020 and I am sure we will 
have questions about that.
    It is not unexpected and I think you will recall when I 
called you with the final budget numbers from the 2020 budget 
my first comment was that the good news is you did not get what 
you asked for and, hopefully, that will be the case again this 
time.
    But you propose a 10 percent cut, similar cuts that you 
proposed in the past in programs that I think we would be very 
reluctant to do, especially in the healthcare workforce 
programs, the medical research programs, the preparedness 
programs, all of which have been talked about even earlier 
today at the members briefing on COVID-19. Home energy, rural 
health care--these programs are unlikely to be cut.
    I, frankly, hope some of the cuts you suggested we can look 
at and decide that there are areas where we can reprioritize 
because we are going to need a little more money this year, in 
my view, than the top line number is likely to give us.
    I do appreciate that in this budget, unlike some in the 
past, the administration has actually tried to focus on 
priorities where we would increase spending, Ending the HIV 
Epidemic, the effort to do that, the effort to improve maternal 
health, to fight the opioid epidemic, also to maintain some of 
the other investments we have made.
    But the budget request also looks at high-quality child 
care, Head Start, and child care development block grants and 
really suggests that they appreciate what they have been 
allowed in budgets in the past to happen there.
    Many of the increases in this budget request were financed, 
again, let me say, by unrealistic cuts, cuts that we do not 
want to make, in my opinion, and cuts that at the end of the 
day you probably would not really want us to make like 
eliminating children's hospitals graduate medical education.
    That is not going to happen. Eliminating LIHEAP (Low Income 
Home Energy Assistance Program)--highly unlikely to happen. It 
slashes healthcare research, an area the subcommittee has 
prioritized the last 5 years that I have chaired this 
committee. And this is an area Senator Murray and I have worked 
together on.
    We are not likely to cut healthcare research and I hope we 
can continue our pattern of increasing healthcare research at 
this incredible time.
    I think we are making a difference. We have seen life 
expectancy numbers go up and quality of life efforts for 
Americans go up because of what is happening with the real 
innovative opportunity in healthcare.
    Americans' life expectancy rose for the first time since 
2014. Last year cancer death declined. They first declined in a 
long time on opioid overdose deaths were part of that.
    New treatments, screening tools, vaccines all make a 
difference and this is such an incredible time to move forward 
in all of those areas based on what we know now and what we 
think is out there in the future with CRISPR technology and 
other things.
    I know you had to make difficult decisions with the budget 
number you had and we will have to do the same thing. 
Hopefully, we can work together to identify priorities and find 
common ground and, hopefully, our committee will be able to 
work together, as I think we have made a real effort to do for 
several years now.
    Two years ago, this subcommittee created an Infectious 
Disease Fund to provide flexibility funding for the department 
for immediate response. You have used that money as intended. 
That first $105 million lets you respond to the coronavirus in 
ways that you would not have been able to respond otherwise.
    However, you know, responding to this particular effort not 
only takes a rapid response, but if we are going to be your 
partners in this, it takes a lot of sharing of information and 
I encourage you to continue to do that.
    We gave you broad authority, for instance, in the 
Infectious Disease Fund. But broad authority also includes 
broad responsibility to be forthcoming with information. When 
we give you this kind of authority to spend money, I think 
everyone on this committee would like a similar kind of 
treatment in your response to how that money is being spent.
    We have asked virtually every day for the department to 
give us specifics on spending money with the proposal that came 
out last night that you and I had a chance to talk about 
yesterday. I think we have a better sense of the path forward 
than we would have had before.
    But whether it is your department or OMB (Office of 
Management and Budget) that makes it hard for you to share 
information, I would just encourage you once again that this is 
going to work better if we have the kind of sharing that allows 
you to have then the kind of flexibility that you would like to 
have.
    One of those things comes with, in my sense, an obligation 
for the other thing, the sharing of information, to be part of 
that flexibility that we have given you.
    We are going to talk a lot today, I suspect, or at least I 
am this morning about the virus, about the supplemental, the 
time that you think that supplemental fills the gap and what 
the backup plan would be if it is not adequate.
    I appreciate, Mr. Secretary, your strong leadership at both 
CDC (Centers for Disease Control and Prevention) and NIH 
(National Institutes of Health) as well as overall at HHS 
(Department of Health and Human Services). I look forward to 
your testimony today. We have both the Chairman and the Vice 
Chairman of the Full Committee with us and I know that Senator 
Murray and I are glad to have both of them there. I think they 
will have some comments to make.
    [The statement follows:]
                Prepared Statement of Senator Roy Blunt
    Good morning. Thank you, Secretary Azar, for appearing before the 
Subcommittee today to discuss the Department of Health and Human 
Services' fiscal year 2021 budget request. We look forward to your 
testimony.
    The fiscal year 2021 budget request mirrors the fiscal year 2020 
budget request in many ways--which isn't unexpected.
    It proposes a $9.7 billion, or 10 percent, cut to the Department. 
Similar cuts that you have proposed before--to healthcare workforce 
programs, medical research, preparedness programs, home energy 
assistance, and rural healthcare--are once again part of this year's 
request.
    I do appreciate that this budget, unlike many in the past, reflects 
specific priorities from the Administration.
    The budget builds off investments this Subcommittee has made to 
support the ``Ending the HIV Epidemic'' initiative, improve maternal 
health outcomes, and prioritize resources to fight the opioid epidemic. 
The budget also maintains the significant recent investments this 
Subcommittee has made in other areas, like supporting high-quality 
child care for working families, including through Head Start and the 
Child Care and Development Block Grant.
    However, many of the increases in this budget request are financed 
by unrealistic cuts. Cuts we cannot take and ones that you would not 
want us to take--like eliminating Children's Hospitals Graduate Medical 
Education or LIHEAP.
    And we know by this point in my chairmanship that I will never 
write a bill that slashes the investment in medical research as the 
budget proposes.
    It is clear that National Institutes of Health-funded research has 
raised life expectancy and vastly improved the quality of life for all 
Americans.
    This fact was reinforced by a recently released report from the 
Centers for Disease Control and Prevention that announced that 
Americans' life expectancy rose for the first time since 2014.
    Smart investments in medical research have brought about new 
treatments, screening tools, and vaccines, particularly in cancer, 
leading to the largest 1 year decline in cancer deaths ever reported.
    But your budget strategy, like many Secretaries before you, puts 
pressure on the Subcommittee to find savings in real ways to try to 
reflect some of your priorities because we simply will not cut the 
programs you did.
    I understand you had to make difficult decisions under a tight 
fiscal year 2021 budget number. We will have to do the same. And my 
goal for fiscal year 2021 remains the same as it has been during my 5 
years as chairman--for us to work together to identify priorities and 
find common ground while responsibly allocating taxpayers' resources.
    Before I finish, I want to touch on the Department's response to 
the coronavirus.
    Two years ago, this Subcommittee created an Infectious Disease Fund 
to provide flexible funding for the Department to immediately respond 
to an infectious disease outbreak. For the ongoing coronavirus 
response, you have used this money as intended.
    I support your efforts to act quickly to contain the effects in the 
United States. However, responding to a potential epidemic like this 
not only takes effective communication between agencies, but a 
recognition that Congress is an important partner throughout the 
response.
    This Committee has provided necessary flexibility to you and your 
Department, but what gives me pause about the Infectious Disease Fund 
in particular, and these flexible pots of funding in general, relates 
to both the broad authority the Department has to use them and the lack 
of accountability that seems to accompany them.
    Since we were initially notified of the use of the Infectious 
Disease Fund on January 25, 1 month ago, the Subcommittee has asked, 
virtually every day, how fast the Department is spending money from the 
Fund and what, specifically, you're spending it on. I know the response 
is rapidly changing and that obligations have a lag time, but I am not 
asking difficult questions or questions that this Subcommittee should 
not receive complete and timely answers to.
    We need transparency into what you are spending now and a 
recognition that the funding flexibility we provide comes with an 
expectation of open communication even during an ongoing response.
    Yesterday evening, the Office of Management and Budget transmitted 
a supplemental request for the coronavirus. This Committee will take 
that request seriously and I hope will quickly act upon it.
    As we work to assess whether the request provides the resources 
needed for a complete response, I hope you will work to provide timely 
answers.
    I want to make sure funding is not a limitation to the response. I 
want to ensure that State and local communities have the resources they 
need.
    And I want to make certain that we are looking at our response 
capabilities for the long game--and not, as we seem to do, leaping from 
one disease outbreak to the next.
    I appreciate your strong leadership, along with the expertise CDC 
and NIH bring to this response. We must continue to work together as we 
protect the homeland.
    Mr. Secretary, I look forward to hearing your testimony today and 
appreciate your dialogue with us about these important issues. Thank 
you.

    Senator Blunt. Senator Murray, let us go to you for your 
opening comments.

                   STATEMENT OF SENATOR PATTY MURRAY

    Senator Murray. Well, thank you very much, Chairman Blunt.
    Secretary Azar, welcome. Thank you for being here.
    Mr. Secretary, let me just say at the top that I am alarmed 
by the recent developments that we have seen in the Office of 
Refugee Resettlement and how it has handled children in its 
care following President Trump's inhumane family separation 
policy.
    I have raised questions with you about that before. I hope 
we can continue that conversation today as well as we review 
this administration's budget proposal and I hope today, we can 
get a straightforward answer on many of the other healthcare 
issues that I am hearing about from my constituents in 
Washington State.
    Because when it comes to helping families across the 
country who are struggling today to afford healthcare, this 
administration has continually said one thing and done the 
opposite, and at the end of the day none of the president's 
empty promises say as much about his healthcare priorities, 
frankly, as his decision to champion a partisan lawsuit that 
could be catastrophic for families.
    Because if Republicans get their way in court they will 
strike down protections for preexisting conditions, strip away 
healthcare families that got their healthcare through exchanges 
and Medicaid expansion and give power back to the insurance 
companies to offer low-quality coverage and leave patients, of 
course, with higher healthcare costs.
    And much like that partisan lawsuit, President Trump's 
partisan budget exposes the truth behind that spin. Despite his 
promise to the contrary, this budget would slash $500 billion 
from Medicare and nearly a trillion from Medicaid, threatening 
millions of families' access to high-quality affordable care.
    In fact, on seemingly every page this budget proposes 
taking huge steps backward on our Nation's most urgent 
challenges including the ones that the administration says they 
care about.
    It proposes a small step forward with additional 
investments to fight HIV transmissions. But it takes an 
enormous leap backwards with the cuts to Medicaid which, by the 
way, covers more than two-fifths of the patients with HIV care, 
not to mention slashing investments in combating HIV overseas.
    These Medicaid cuts would take us in the wrong direction 
when it comes to addressing mental and behavioral health 
challenges like the ongoing drug overdose crisis or the 
increasing suicide rate by making it harder for people to get 
the care they need.
    In some States that have expanded Medicaid the program 
covers four out of five people receiving treatment for opioid 
addiction. To make matters worse, for behavioral health the 
budget eliminates funding for the new suicide prevention 
initiative at the Centers for Disease Control and Prevention, 
which Congress included last year in our bipartisan spending 
bill.
    And then there is the maternal mortality rate, which is 
worse here in the United States than in any developed country 
in the world. Each year 700 women in our country die from 
pregnancy-related issues. Those deaths are mostly preventable 
and the impacted women are disproportionately black and Native 
American.
    Instead of treating this like the emergency that it is, 
this budget actually offers a sleight of hand. It proposes 
expanding the maternal mortality initiative Congress created in 
2018 by $75 million and I appreciate that.
    But, unfortunately, that pales in comparison to the 
proposal to cut over a hundred times that amount from Medicaid, 
which actually pays for nearly half the births in this country.
    And if that were not bad enough news for women and 
families, this budget continues the Trump/Pence 
administration's harmful trend of putting ideology over 
evidence and patient health by excluding Planned Parenthood 
from Federal funding and eliminating the teen pregnancy 
prevention program.
    At a time when our Nation is facing a health professional 
shortage, this budget proposes cutting nearly $800 million from 
programs that support tuition assistance, loan forgiveness, and 
training for several hundred thousand health professionals 
annually.
    And at a time when too many families are already forced to 
choose between paying for healthcare or other basic needs, this 
budget seems to go out of its way to make things worse for 
people living on the brink of poverty.
    It eliminates safety net programs and critical assistance 
to millions of people like the Low-Income Home Energy 
Assistance Program which, as we know, helps families afford 
heating and cooling, and the community services block grant, 
which gives states resources to address the challenge of 
poverty.
    It eliminates the social service block grant and greatly 
reduces programs, which help families facing adversity from 
keeping their heads above water. And as it continues the strong 
bipartisan investments in child care and Head Start Congress 
secured in our last spending bill, this budget eliminates 
funding for preschool development grants, which provide high-
quality preschool to tens of thousands of families.
    Finally, Mr. Secretary, as you know, I have been in close 
contact with health experts dealing with the 2019 novel 
coronavirus outbreak, which you declared a public health 
emergency last month.
    As we work to bring hundreds of Americans from China's 
Hubei Province and affected cruise ships safely back home and 
quarantine them for 2 weeks at a cost of, roughly, $6 million 
per flight, I have been pressing for more information on what 
resources are needed.
    I sent a letter to you and the Office of Management and 
Budget Director Mick Mulvaney earlier this month expressing my 
deep concerns about this.
    Now, you finally sent an emergency supplemental request 
last night, like I have been urging, and I am very concerned 
this request is not enough to ensure that we are putting all 
the necessary resources towards this emerging threat including 
making sure our States and local public health departments have 
what they need to respond to this crisis and being reimbursed 
for those costs.
    And I am very concerned about how thin the details on that 
are because, despite what this budget proposes, not a single 
public health expert has told me the thing we really need to do 
right now is cut the CDC's program by 9 percent or cut critical 
global health programs by $80 million or cut the Infectious 
Disease Rapid Response Reserve Fund by $35 million or cut 
public health preparedness and response programs by $120 
million.
    This is not going to help us deal with this. So while I 
recognize the efforts happening across your department to 
contain this virus, I have to say this is unacceptable. It is 
important that we stay ahead of this crisis and we are ready 
when additional cases are detected in the U.S., meaning we 
cannot plan on the cheap or at the last minute.
    I have always said a budget is a reflection of our values 
and that applies here. While President Trump may not always 
tell the truth about his values, this budget speaks volumes to 
all of us.
    It leaves no doubt that the president is not serious about 
fighting for women's or for families' healthcare or addressing 
national crises like drug addiction, maternal mortality, or 
suicide.
    He is serious about cutting Medicaid and Medicare and 
cutting critical public health programs and safety net programs 
and healthcare workforce programs, and more.
    Families across the country should know that we, as 
Democrats, have no intention of letting those cuts happen. We 
are going to continue to fight for patients and against these 
attacks.
    Senator Blunt. Thank you, Senator.
    Chairman Shelby.

                 STATEMENT OF SENATOR RICHARD C. SHELBY

    Senator Shelby. Thank you. Thank you, Senator Blunt.
    Dr. Azar, you bring a lot of experience at the right time 
in your job. I thank you for your service. I would like to 
focus on the current crisis that we have that face us in the 
world and could be here and how you are going to deal with it 
and so forth.
    To many people--I think the American people are very 
concerned and should be. I am concerned. This is a serious, 
serious disease that if it keeps spreading nobody knows better 
than you what it could do here. It could be an existential 
threat to many people in this country.
    This is not politics. This is doing our job for the 
American people. I know the requests you made, the supplemental 
$1.25 billion and some others. But money should not be an 
object. We should be trying to contain and eradicate as much as 
we can this in the U.S. Make sure it does not spread in the 
U.S. but help our friends all over the world because it is to 
our advantage.
    Some people believe this is a lowball number here. I do not 
know. But I would like to hear from you on this because this is 
not the time to try to shortchange the American people on 
anything or say OMB has done this and that, whoever it is or 
whatever administration it is, Democrat or Republican.
    This is the time to step up. I think you know this probably 
better than I do. But there is a lot of concern in America 
today and will be is this going to spread. You know, we brought 
some people into this country. Where is it going to go? How are 
we going to contain it?
    I am looking forward to your testimony. I am sure you do 
not have all the answers but you have probably got more than a 
lot of people.
    Thank you for your service again.
    Senator Blunt. All right. Well, thank you, Chairman.
    And, Senator Leahy, do you want to wait for your question 
time or do you have an opening?
    Senator Leahy. I have a--I do have a question on a proposal 
made most recently, which is vague at best, on the coronavirus.
    Senator Blunt. All right. Well, let us go ahead and, 
Secretary Azar, again, we are glad you are here. We are glad 
you are here and look forward to your opening statement and 
maybe you can answer some of these questions even in that 
statement.

                  SUMMARY STATEMENT OF HON. ALEX AZAR

    Secretary Azar. Great. Thank you very much, Chairman Blunt, 
Ranking Member Murray, and Chairman Shelby and Ranking Member 
Leahy--Vice Chairman Leahy.
    Thank you very much for having me and 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 the third time, especially after the 
remarkable year of results that the HHS team has produced.
    With support from this committee, this past year we saw the 
number of drug overdose deaths decline for the first time in 
decades, another record year of generic drug approvals from 
FDA, and historic drops in Medicare Advantage, Medicare Part D, 
and Affordable Care Act exchange premiums.
    The president's budget aims to move toward a future where 
HHS programs work better for the people we serve, where Human 
Services programs put people at the center and where America's 
healthcare system is affordable, personalized, puts patients in 
control, treats you like a human being, not like a number.
    HHS has the largest discretionary budget of any non-Defense 
Department, which means the difficult decisions must be made to 
put discretionary spending on a sustainable path. This 
committee has made important investments over the years in some 
of the HHS's large discretionary programs including at the 
National Institutes of Health and we are grateful for that 
work.
    The president's budget proposes to protect what works in 
our healthcare system and make it better. I will mention two 
ways that we do that. First, facilitating patient-centered 
markets and, second, tackling key impactable healthcare 
challenges.
    The budget's healthcare reforms aim to put the patient at 
the center. It would for instance, eliminate cost sharing for 
colonoscopies, a lifesaving preventive service. We would reduce 
patients' costs and promote competition by paying the same for 
certain services regardless of setting, and the budget endorses 
bipartisan bicameral drug pricing legislation.
    These combined reforms will improve Medicare and extend the 
life of the Hospital Insurance Fund by 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 America's rural health crisis including telehealth 
expansions and new flexibility for rural hospitals.
    The budget increases investments to combat the opioid 
epidemic including SAMHSA's (Substance Abuse and Mental Health 
Services Administration) State Opioid Response Program and we 
appreciate this committee's work with us to give States 
flexibility in that program to address stimulants like 
methamphetamines.
    We request $716 million for the president's initiative to 
end the HIV epidemic in America by using effective evidence-
based tools. Thanks to funding appropriated by this committee, 
we have already begun implementing this initiative.
    The budget reflects how seriously we take the threat of 
other infectious diseases such as the China coronavirus by 
prioritizing funding for CDC's infectious disease programs and 
maintaining investments in hospital preparedness.
    We now have 14 cases of the China coronavirus detected in 
the United States involving travel to China or close contacts 
with those travelers, three cases among Americans repatriated 
from Wuhan and 40 cases among American passengers repatriated 
from the Diamond Princess.
    While the immediate risks to individual members of the 
American public remains low, there is now community 
transmission in a number of countries including outside of 
Asia, which is deeply concerning. We are working closely with 
State, local, and private sector partners to prepare for 
mitigating the virus's potential spread in the United States, 
as we will likely see more cases here.
    Today, NIH will announce the launch of the first U.S. 
clinical trial for an investigational antiviral at the 
University of Nebraska Medical Center.
    Yesterday, OMB sent a request to make $2.5 billion in 
funding available for preparedness and response including for 
therapeutics, the vaccines, personal protective equipment, 
State and local support, and surveillance, and I look forward 
to working closely with Congress on that.
    Lastly, when it comes to human services the budget cuts 
back on programs that lack proven results while reforming 
programs like TANF (Temporary Assistance for Needy Families) to 
drive State investments and supporting work and the benefits it 
brings for well-being.
    We continue the fiscal year 2020 investments Congress made 
in Head Start and childcare programs, which promote children's 
well-being and adults' independence.
    This year's budget aims to protect and enhance Americans' 
well-being and deliver Americans a more affordable personalized 
healthcare system that works better rather than just spends 
more.
    I look forward to working with this committee to make that 
common sense goal a reality.
    Thank you, Mr. Chairman.
    [The statement follows:]
                  Prepared Statement of Hon. Alex Azar
    The President's Fiscal Year 2021 Budget (Budget) is built around a 
vision for HHS and a vision for American healthcare. We are building 
toward a future where HHS's programs work better for the people we 
serve; where America's healthcare 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 healthcare 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 two 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 fiscal year 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 healthcare 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 healthcare 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 healthcare 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 & 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 healthcare options in the world, 
rising healthcare 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 healthcare 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 healthcare 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 healthcare system 
into one that better pays for value and promotes care coordination. 
These proposed rules reduce unnecessary regulatory burden on physicians 
and other healthcare 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 healthcare 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 healthcare 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 healthcare system. In 
addition, the Emergency Triage, Treat, and Transport Model provides 
greater flexibility to ambulance care teams to address emergency 
healthcare 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, 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 fiscal year 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 fiscal year 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 healthcare 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 D.C. 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 fiscal year 
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 healthcare 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 Healthcare.
    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 healthcare 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 healthcare, 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 healthcare 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 healthcare 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 fiscal year 2019, ACF 
cared for 69,488 children, the highest number in the program's history. 
To ensure adequate shelter capacity and care in fiscal year 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 fiscal year 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 fiscal year 2017 to 
more than 63,000 in fiscal year 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 fiscal year 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 healthcare as we shift from a fee-for-service 
to a value-based healthcare 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 fiscal year 
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 decisionmaking across the enterprise.
    In fiscal year 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 fiscal year 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 
healthcare, while poorly designed regulations can come between doctors 
and patients, reducing the quality of care and the essential trust to 
that relationship. From fiscal year 2017 to fiscal year 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.

    Senator Blunt. Thank you, Mr. Secretary.
    I will say for the members that there are votes scheduled 
at 11:30 and we will try to keep the hearing going through at 
least the first two of those votes, and so there will be some 
effort made for members to leave and take the first vote and 
come back and we will see if we cannot make that work.

                        LIVER ALLOCATION POLICY

    Glad to have you. Glad to have your time. I want to ask two 
questions. One is on the liver allocation policy. Senator Moran 
and I sent you a letter on January 21st urging that you step in 
to prevent what we thought was a shortsighted and ill-thought-
out policy.
    Roughly, 40 percent of the country will be harmed by the 
new process, which goes from a regional allocation to a 
nationwide allocation.
    We have already seen, Mr. Secretary, increased cost per 
transplant, increased waste in what was already a complex 
system and organs that were discarded because people had to 
travel too far to get the organs to bring back to the 
recipient.
    Even the Federal judge in the litigation referred to what 
would be a regional bias here. The government contractor on 
this effort provides no information to the committee on how the 
decision was made.
    They overruled experts in their own Liver and Intestine 
Committee. Now they want to continue to have all the evidence 
in the litigation under seal.
    So, my question to you is, one, what made you determine 
after our January letter that you could not do anything, and 
two, are you willing to do something to work to get the 
evidence and what supposedly should have been available to this 
outside contractor to make that evidence public?
    Secretary Azar. So, Chairman, I share your concerns and 
frustrations, and HHS has actually requested OPTN (Organ 
Procurement Transplant Network) to reconsider their decision to 
ensure a full consideration of the comments that they received 
from Kansas and Missouri.
    As you know, HHS does not make decisions on organ 
allocation policy. The Organ Procurement Transplant Network is 
responsible for organ allocation policy, and while we are 
charged with oversight of OPTN, those decisions by statute are 
delegated to the OPTN and I do not have the ability to change 
those decisions.
    We continue to look for authorities that might do that and 
we certainly look forward to working with you if there were 
legislative proposals that might give me authority. But those 
have actually been walled off from the secretary.
    Of course, the number-one thing we can do is increase the 
number of livers available and that is why we are working to 
reform our organ procurement policies and our oversight 
policies and practices regarding the organ procurement 
organizations in the country so that we can dramatically 
increase the number of organs available in this country.
    But I am happy to keep working with you on this liver issue 
but my degrees of freedom are limited, quite frankly, by 
Congress in my ability to influence the OPTN.
    Senator Blunt. Well, let us continue to see if we cannot 
find ways to help you have more ability in that oversight 
process to have oversight.

                    CORONAVIRUS SUPPLEMENTAL REQUEST

    Let us go to the supplemental request, the emergency 
supplemental. I understand it to be $2.5 billion. About half of 
that would be counted as emergency spending and the other half 
would be paid for in various ways like the $105 million that 
you will soon have gone through.
    The fund I mentioned earlier today, the Infectious Disease 
Response Fund--the infectious disease reaction ability you did 
not have before--talk to us a little about putting that 
together, your thoughts for internal transfers.
    We are always concerned, as we should be, about big amounts 
of money being transferred under the secretary's authority in 
different ways than this committee and with the president's 
signature decided that money should be spent.
    Secretary Azar. Yes. So, first, let me be clear. We would 
like to focus on the top line of the $2.5 billion in terms of 
the key strategic needs. We have, of course, put forward a 
supplemental that would allow offsets and transfers to pay for 
about half of that.
    But, of course, that is Congress's decision and we look 
forward to working with you if those choices make sense to you 
or if there are other sources or offsets or approaches that you 
would like to take.
    In terms of the top line, that $2.5 billion, I focused my 
energies here in five key critical success factors. The first 
is we need to expand our surveillance system in the United 
States for the China coronavirus to be comparable to our flu 
surveillance system. This is the backbone of our effective 
public health response at the State, local, and Federal level 
to have that surveillance.
    Second, we need support for State and local governments. 
While we provide almost half of the funding of State and local 
public health departments and $675 million a year for emergency 
preparedness by those departments, we do believe we need more 
money to support contract tracing, communications with impacted 
individuals, and laboratory test work, and we have that in 
here.
    Third, we have to take advantage of telehealth and other 
innovation. And fourth, we need to support the research, 
development, and procurement of vaccines and therapeutics, and 
so there is money in there to support both of those.
    Then, finally, we need to support the acquisition of 
personal protective equipment, especially masks, into the 
Strategic National Stockpile. So those five key areas are where 
the funding is directed.
    Senator Blunt. Thank you, Mr. Secretary.
    Based on, again, the other challenges we are facing this 
morning, I am going to keep my questions to 5 minutes and hope 
everybody will do their best to keep theirs, and if there is 
time for a second round and people want to stay for that we 
will have that. But be sure everybody gives everybody else the 
ability to have a first round.
    Senator Murray.

                        CORONAVIRUS PREPAREDNESS

    Senator Murray. Thank you, Mr. Chairman.
    At the administration's briefing this morning on the 
coronavirus, we were told by the experts at NIH and CDC that 
there is a very strong chance of an extremely serious outbreak 
of the coronavirus here in the United States.
    So I want to talk about the preparations of this 
administration and what you have been doing. You have had more 
than a month now to prepare for this increasing likelihood and 
I want to ask you is our country ready?
    Secretary Azar. So our country is preparing every day and 
the effective aggressive containment measures that we have 
taken at our borders as well as working with our public health 
departments.
    Senator Murray. I meant----
    Secretary Azar. So I bought us time to continue 
preparedness. One is always advancing preparedness. Every day 
one advances those activities and the emergency supplement 
would help that.
    Senator Murray. Okay. Mr. Secretary, I only have a few 
minutes. Let me be really clear, because you sent over a 
supplemental that was not clear to me at all. You just 
mentioned a number of things from tracing, State and local 
governments needing their health cares and hospitals ready for 
this.
    You have talked about protective masks. You talked about 
surveillance system. I did not see anything in that request 
that specifically says how much each of those are going to 
cost. And we know--we have seen this outbreak in China now. We 
know it is going to other countries.
    It quickly overwhelms a healthcare system. It puts patients 
who do not have the virus at risk, who suffer from other 
conditions. We know that medications become very difficult.
    Did you stockpile any of these critical supplies that we 
are told we need--masks, protective suits, ventilators, 
anything? Is that stockpiled and ready?
    Secretary Azar. So we do have in the Strategic National 
Stockpile ventilators. We have masks. We have all the 
appropriate----
    Senator Murray. Enough?
    Secretary Azar. Well, of course not or we would not be 
asking for a supplemental to seek more money to procure more of 
that for this circumstance. This is a very--this is an 
unprecedented potential severe health challenge globally and 
will require these additional measures.
    Senator Murray. Okay. Well, I did not see any numbers in 
your request.
    Secretary Azar. We will be briefing committee staff and 
members. This just came over last night and we will be briefing 
you on those details and supporting you with technical 
assistance.

                      LONG-TERM COSTS OF RESPONSE

    Senator Murray. You just gave us a very long list of things 
that are needed, most of which we do not have, which you cannot 
just buy tomorrow. And I am very concerned that this is not 
only inadequate in terms of numbers but in terms of specifics 
of what we are going to need and we need to know that from your 
experts.
    You know, health experts including your own tell us that 
this outbreak could be very long lasting and this is a very 
vague request for supplemental money and I just think it is a 
Band-Aid and I want to know why.
    We know this is coming. We have been watching in China. 
Everybody has been telling this. What are the long-term costs 
of a sustained response? Do we know that? Including the 
manufacturing, by the way, of diagnostics that we know we are 
not ready for right now.
    Secretary Azar. Well, we have the details. We will be 
providing them to the committee and the committee staff and we 
want to work with you on this to ensure that it is an effective 
supplemental that meets your needs.
    This funding request is for 2020 money only at this point. 
It would have a permission for carryover into 2021 spend. But 
then we would work with the Congress, the appropriators, on 
adjusting any 2021 needs as we learn.
    We are really learning day by day and week-by-week here of 
the contours of this disease as well as the spread of the 
disease and its potential impact and that will help inform 
those 2021 discussions that we would, of course, have with this 
committee, going forward, in the next couple of months.
    Senator Murray. Well, I just have to say I am very 
concerned about this administration's attitude towards this.
    If a pandemic is coming and we are disregarding scientific 
evidence and relying on tweets and an emergency supplemental 
without details and we are not stockpiling those things right 
now that we know we might possibly need for this or for any 
future pandemic. I am deeply concerned that we are way behind 
the eight ball on this.
    Secretary Azar. Well, we actually have been aggressively 
moving. It has been a month and a half since this situation 
arose and we have enacted the most aggressive containment 
measures in the history of our country in terms of our borders.
    I have used the first Federal quarantine authority in 50 
years of an HHS secretary. We have worked with our State and 
local partners----
    Senator Murray. Can you assure every single American today 
that if this pandemic hits our shores that we have everything 
available and we have stockpiled it and we are ready to go?
    Secretary Azar. That is precisely why we need to work with 
Congress for additional appropriations to enable procurement. 
But right now--and we have been very clear. Dr. Fauci has told 
you just this morning we do not have a vaccine. One cannot have 
a vaccine for--one cannot--well, the--

                            DIAGNOSTIC TESTS

    Senator Murray. No, I am not asking about--I am asking 
about diagnostics and testing, which we are not--we do not have 
enough currently.
    Secretary Azar. Well, one--well, yes, we have a diagnostic. 
CDC invented a diagnostic in historic time, within one week of 
the sequence arriving.
    Senator Murray. But it is not available to the 137 CDC----
    Secretary Azar. It is available now at CDC and then 12 
sites have been able to validate it. We are working with--CDC 
and FDA (Food and Drug Administration) are working together on 
a modified version of the test that would enable qualified 
control at the third reagent stage or elimination of that if 
possible to enable further spread of the diagnostic.
    Senator Murray. Mr. Secretary, I am out of time. But I am 
told that the diagnostic does not work.
    Secretary Azar. That is incorrect. That is simply flatly 
incorrect. The diagnostic works at CDC and at 12 sites it has 
been validated. At other sites, we are working to get them 
validated.
    This is a working diagnostic. In the areas of the 170 labs 
where it was sent, there was a problem in the third reagent 
stage of it that led to inconclusive results against control.
    We are assessing right now with FDA whether that actual 
step is needed in the process and we have 70 private sector 
diagnostic manufacturers who are working to bring forward 
diagnostics and we will work with those on emergency use 
authorization.
    Senator Murray. Working to bring forward. But we are not 
there yet.
    Secretary Azar. We are now, what, 50 days into it. This is 
historic. No administration, no CDC in American history, has 
delivered like this.
    Senator Murray. I do not question that at all but I do 
question our ability with a very small unspecified supplemental 
and the lack of preparedness that we have to be ready for this.
    Thank you, Mr. Chairman.
    Senator Blunt. Senator Shelby.

                    CORONAVIRUS SUPPLEMENTAL REQUEST

    Senator Shelby. Mr. Secretary, I want to follow up on what 
Senator Murray was talking about.
    One, it seems to me at the outset that this request for the 
money, the supplemental, is low-balling it possibly and you 
cannot afford to do that. I hope the--we want to help the 
administration.
    We want to help you do your job. But if you low-ball 
something like this you will pay for it later. But you are not 
only dealing with the crisis. You are dealing with the 
perception and the concern of the American people, right. Both, 
at the same time.
    I know you cannot develop a vaccine and immunize everybody 
in America from something that has just fallen on us all at 
once, and the world, really, coming at you. But what are you 
specifically doing--what are your guidelines and this 
administration to contain this in America?
    We do not want this to spread. If it spreads, it is going 
to be hard to contain. What are you doing and what do you 
propose to do?
    Secretary Azar. So we are taking----
    Senator Shelby. And what is your message to the American 
people that may be watching this hearing?
    Secretary Azar. So the steps that the president has taken 
are the most aggressive containment measures ever in history in 
terms of travel restrictions at our borders, funneling 
passengers, restricting foreigners from coming into our country 
if they have been in China, travel restrictions and advisories 
to countries, in addition to, of course, the solid State and 
local public health response which actually identified all but 
one of the 14 cases here in the United States. One of them was 
identified through our aggressive screening measures at the 11 
funneling airports.
    So that is part of it. But then the aggressive measures we 
need now are we have a historic opportunity with the vaccine. 
We have developed a vaccine candidate. That should--Dr. Fauci 
talked about that in the Wall Street Journal today going to 
clinical trials we hope within 3 months from development.
    That would be a historic development of a product. We are 
supporting and working with manufacturers on potential 
therapeutics that could be cures or mitigation for individuals 
who contract this.
    So we work to contain as much as possible but at some point 
if there is sustained human-to-human transmission we also work 
to mitigate through our traditional public health tools and 
those are the steps that we would take.
    I was very clear when we enacted our containment measures 
at the border. We cannot hermetically seal off the United 
States to a virus.
    Senator Shelby. No, I know.
    Secretary Azar. And we need to be realistic about that. And 
so this virus we will have----
    Senator Shelby. Life goes on in some form.
    Secretary Azar. It does, and we will have more cases in the 
United States and we have been very transparent about that and 
we will then work to mitigate the impact of those.
    Senator Shelby. And when does it get to the point in the 
U.S.--you say we will have more cases and I think that is 
logical--where we are over concerned? We are really concerned. 
Is it because it is spread city to city?
    Secretary Azar. Well, we always look for sustained human-
to-human transmission----
    Senator Shelby. But you have got to have these models and--
--
    Secretary Azar. We do. We do. So what we look for is 
sustained human-to-human transmission especially that is 
unidentified.
    That is what is particularly concerning about Iran and 
Italy right now is we have apparently sustained human-to-human 
transmission with no identifiable connection to existing cases. 
That is very, very concerning to see that in other countries 
and that is what we would certainly look for here.
    Right now, it is important to remember the 14 cases that we 
have that are in the U.S. as well as the 40 from the 
repatriated individuals from China and Japan, in every single 
instance we know why that person has the novel coronavirus. We 
know.
    That is a product of the world's finest public health 
system, which allows us to have that level of knowledge on this 
rapidly developing situation.

                         CORONAVIRUS TREATMENTS

    Senator Shelby. Well, what is the treatment for it?
    Secretary Azar. Right now, one has to simply--because there 
is no treatment, one treats the symptoms as one does for other 
therapies.
    There are some experimental products and clinical trials. 
One is a Gilead product known as remdesivir that some 
individuals have been treated under an IND (Investigational New 
Drug) protocol for a clinical trial.
    We have--that product is being tested in two trials in 
China, two 500-person arm trials in China as well as now, as I 
mentioned this morning, in the University of Nebraska and I 
believe also in Japan.
    Senator Shelby. Mr. Secretary, I believe that this 
committee--Senator Leahy is here, Senator Blunt and Senator 
Murray are the leaders of this subcommittee. I believe that we 
will be able to mindset to fund this crisis, not to underfund 
it in any way, and I hope the administration will look at this 
as something that they cannot afford to let get out of hand, 
period, or the perception that it is getting out of hand.
    Secretary Azar. Well, Chairman, I want to assure you that I 
am fully supportive of this $2.5 billion request. I was part of 
architecting it. It is what I believe we need for 2020.
    But, of course, if Congress differs with the power of the 
purse, we will work with you, provide technical assistance to 
try to make sure it meets what you view as the needs are.
    Senator Shelby. Whatever. Thank you, Mr. Chair.
    Senator Blunt. Thank you, Chairman.
    Senator Leahy.
    Senator Leahy. Thank you, Mr. Chairman, and welcome, 
Secretary.

                    FISCAL YEAR 2021 BUDGET REQUEST

    Like so many others up here, both Republicans and 
Democrats, I am concerned with the budget the administration 
has put forward for the Department of Health and Human 
Services.
    Obviously, you were involved with it but it seems to have 
been drafted to hit an arbitrary target to slash funding 
without any realization of real-world impact of the proposed 
cuts.
    In fact, a move that is completely confounding in the midst 
of the novel coronavirus outbreak you wanted to slash funding 
in fiscal year 2021 to varied programs to help us combat 
dangerous infectious diseases.
    And while we might talk about having a vaccination for the 
virus that is still about 2 years away, it has spread to 30 
countries. It has infected more than 79,000 people. It has 
caused at least 2,600 deaths.
    Hundreds of Americans are restricted to U.S. military bases 
under a Federal government quarantine, and that is the first 
time in 50 years.
    But you proposed to cut $3.1 billion from the National 
Institute of Health, nearly $700 million from Centers for 
Disease Control and Prevention programs, roughly, $100 million 
from public health preparedness and response programs. These 
are the very programs we are going to have to rely on to combat 
coronavirus and other infectious diseases.
    If Congress went along and made the cuts that you and the 
administration has asked for, you would not be able to keep the 
public safe when the next threat emerges, and one will. So why 
would you propose such cuts? How does it make any sense?
    Secretary Azar. Well, Vice Chairman, as you know, we have a 
tight budget environment but we prioritized actually the 
infectious disease preparedness and emergency response. So, for 
instance, at CDC those three activities were prioritized and 
actually increased the propose funding by $135 million in the 
2021 budget.
    Now, of course----

                 INFECTIOUS DISEASE RAPID RESPONSE FUND

    Senator Leahy. Well, the CDC's Infectious Disease Rapid 
Response Reserve Fund, which we had created to help you, is 
running out of money, including the number--and now we see an 
increased number of infectious people, 53 in the U.S.
    Secretary Azar. We estimate----
    Senator Leahy. How is that being careful with these--and 
this has been going on for months and last night we get this 
somewhat vague request for emergency funding. If I was cynical, 
and Vermonters never are, I might think it was rushed over just 
in time for your appearance before this committee this morning 
and that is why it is vague enough.
    Secretary Azar. So the Infectious Disease Rapid Response 
Fund at CDC was funded by Congress in 2020 as well as 2019 and 
so it is current year money.
    We are running out of that money, which is why we have sent 
over that we plan to do transfer and reprogramming using the 
existing authorities for 2020 appropriations and precisely why 
we are asking for an emergency supplemental.

                    CORONAVIRUS SUPPLEMENTAL REQUEST

    Senator Leahy. But you would take a half a billion dollars 
out of the money appropriated for the Ebola threat.
    Secretary Azar. Those would be proposed offsets or trade 
offs for the emergency supplemental. If the appropriators do 
not want to do that--that is just an option for the 
appropriators for the----
    Senator Leahy. Did you have any of your requests for 
supplemental funds, any requests that you made to OMB, were 
there any of them that were denied by OMB?
    Secretary Azar. Well, I am not going to discuss internal 
deliberations.
    Senator Leahy. Why not?
    Secretary Azar. That is not proper to discuss internal 
deliberations.
    Senator Leahy. Why is it not proper? I have heard that 
question asked by--during Democratic administrations and 
Republican administrations over my 40 year on this committee 
and it has been answered.
    Secretary Azar. I would never answer internal deliberations 
with the White House. But I will tell you I am completely 
supportive of the $2.5 billion request. It does exactly what I 
want, which is to focus on those five critical to success 
factor areas.
    Senator Leahy. Okay. So what you want is a proposal that 
would divert $135 million from other important programs 
including $37 million from LIHEAP, millions from substance 
abuse, $7 million from Medicare and Medicaid programs.
    So I will not ask you deliberation but you just want to cut 
a whole lot of things that we rely on.
    Secretary Azar. Well, those are options for funding half of 
the cost of the emergency supplemental. But if Congress makes a 
different choice Congress makes a different choice. These are 
the top line.
    Senator Leahy. Where does the other half come from?
    Secretary Azar. That would be emergency supplemental. New 
money that you would have to come up with.
    Senator Leahy. Okay. So the things you want--some of the 
NIH funding, the Ebola funding--your recommendation, and you 
are the expert in this, is to cut that out.
    Secretary Azar. It is a proposal of how to fund half of the 
cost of the total response.
    Senator Leahy. It is your proposal.
    Secretary Azar. That is our proposal. But if Congress 
disagrees with other approaches there are other ways to get 
there.
    Senator Blunt. Thank you, Senator Leahy.
    Senator Alexander.
    Senator Alexander. Thank you, Mr. Chairman.

                 NATIONAL INSTITUTES OF HEALTH FUNDING

    Mr. Secretary, welcome. Before I ask--get into coronavirus 
I want to congratulate Senator Blunt and Senator Murray and 
Senator Durbin and Leahy and Shelby and members of the 
subcommittee for the last 5 years of funding for the National 
Institutes of Health.
    Over that 5 years, discretionary spending, which is about a 
third of our budget that the Federal Government spends, has 
gone up 20 percent.
    But funding for the National Institutes of Health has gone 
up 39 percent and, I might add, the subcommittee that deals 
with the Office of Science in the Department of Energy that 
Senator Feinstein and I work on has gone up 38 percent. So one 
of the best kept secrets in Washington is the big increase in 
funding for biomedical research and science and I want to 
congratulate this committee for its part of it.

                              CORONAVIRUS

    I think one of our responsibilities as members of the 
Senate is to help the American people get a fair view of 
exactly how threatening to them individually the coronavirus 
is.
    Looking around the world, there is reason for alarm. Ten 
days ago, for example, there were 49,000 confirmed cases in the 
world. Ten years ago in China there were 48,000 confirmed 
cases.
    Today in China there are 79,000 confirmed cases in the 
world and there are 77,000 in China, and we read about problems 
and popping up in Italy, which could get across their borders, 
and in Iran and other places, South Korea.
    And not only do we have the problem of a rapidly spreading 
virus, which could jump into our country. We have to think 
about what items manufactured in those countries could mean for 
us with 13 percent of our prescription drugs--our drugs being 
manufactured in China, for example.
    Are we going to have shortages? And even beyond that with a 
quarter or so of everything that we use in this country being 
made in China will we have supplies for our automobiles and our 
other things that we make in this country and what will it do 
to our economy.
    So looking around the world, there is a reason to be 
alarmed. But, now, looking at home, let me go through what the 
facts are at home. We have known about this for about 2 months, 
right, about 50 days.
    Secretary Azar. Yes, about 50 days.
    Senator Alexander. And 10 days ago, if I am right, we had 
detected 14 cases in the United States.
    Secretary Azar. I believe that is correct, yes.
    Senator Alexander. And today we have detected 14 cases in 
the United States----
    Secretary Azar. That is correct.
    Senator Alexander  [continuing]. In addition to the 39 
cases of Americans who have been brought home from overseas and 
isolated in this country because they might have been infected 
there.
    Secretary Azar. Exactly. The imported cases.
    Senator Alexander. And during that time, you have begun to 
develop a vaccine, which will not be ready for a year or longer 
but you are doing that more rapidly than any other time in the 
history of our country.
    Secretary Azar. That is correct.
    Senator Alexander. And my question is going to be with this 
alarming situation in the world, what have you been doing right 
at home that caused us to see a situation where this huge 
country of ours we only have 14 cases a year ago--a mean, 10 
days ago and 14 today?
    My guess is, is 20 years of preparation by Democrats and 
Republicans on this committee and Democrats and Republican 
presidents to be ready for pandemics, number one. Number two, 
it is the extraordinary health system we have in this country, 
State and local, doing their job.
    And number three, it is the first and most aggressive 
quarantine requirements that you have done in 50 years.
    So if we are alarmed about what has gone on around the 
world, what can we learn about the last 50 days in this country 
that you have been doing right that makes us be able to say 10 
days ago there were 14 cases and today there are 14 cases at a 
time when around the world cases are going up?
    Secretary Azar. So we are bearing the fruits, actually, of 
our pandemic flu preparedness activities, which I was one of 
the architects of in the Bush administration and that Congress 
funded.
    We are seeing the public health infrastructure from that 
that is coming to fore. One of the most important things we did 
as soon as alerted to this and as soon as we had a genetic 
sequence and understood the nature of the symptoms of this 
disease was to alert our State and local public health partners 
and our health professionals, and that is why 13 of those 14 
cases were identified by healthcare professionals, astutely 
seeing that these were individuals who had been in Hubei 
Province and presented with flu-like symptoms, got into the 
system and took advantage of that one-week-developed CDC test 
to confirm results.
    So that is the--that kind of public health infrastructure, 
the world's best, is the backbone of our response activities 
here.
    In addition, we worked on aggressive border containment 
measures and we have worked with China to try to get 
transparency and get information. We still do not have, 
unfortunately, solid information to take to the bank on 
severity, on transmissibility, on incubation period, on 
asymptomatic transmission.
    Senator Alexander. I am out of time. But I think what I am 
hearing you say you would do more of what you have already 
done, properly funded?
    Secretary Azar. Yes.
    Senator Blunt. Thank you, Senator Alexander.
    Senator Schatz.
    Senator Schatz. Thank you, Mr. Chairman.

       FISCAL YEAR 2021 BUDGET REQUEST FOR PREPAREDNESS PROGRAMS

    Thank you, Secretary, for being here. This committee has a 
long tradition of bipartisanship and I know Secretary, you and 
I have had a couple of disagreements in private and in public. 
So I want to kind of see whether we can find some common ground 
in fighting the coronavirus.
    The president's budget cuts the Infectious Disease Rapid 
Response Reserve Fund, the Public Health Preparedness and 
Response Fund, Hospital Preparedness Program, and the 
Epidemiology and Laboratory Capacity Program.
    So given everything that has happened over the last 50 days 
I want to give you an opportunity, and given the context here, 
which is last night you proposed a $2.5 billion supplemental, 
do you want to rescind those cuts to the base budget of your 
agencies that deal with this problem?
    Secretary Azar. Well, it is a good question, Senator. As I 
mentioned to Chairman Blunt, this is a request focused on 2020 
money, so money to be spent----
    Senator Schatz. Not--hold on.
    Secretary Azar. Well----
    Senator Schatz. Hold on. I am not asking you about the 
supp. I am asking you about the president's budget, which cuts 
all those programs which I described, and the question is a 
simple one, because I have a couple of other questions I would 
like to get to.
    Will you rescind those cuts? Will you ask us to restore 
those programs or will you not?
    Secretary Azar. So as I said to Chairman Blunt, we will 
work with you over the coming months as we learn more about 
this disease on whether to modify the 2021 appropriation 
request in light of that. We do increase by $135 million CDC's 
budget around preparedness, emergency response, infectious 
disease, and global health security.
    Senator Schatz. I am not going to get too much into the 
weeds there but I will just offer that actually is a shell 
game. There are four key programs that deal with this problem. 
They are being cut.
    The CDC overall is being cut by 9 percent. And so you may 
have increased a line item or two but that is a talking point. 
That is not the fact of the matter.
    And this committee will very likely reject these cuts. But 
it is absurd to me that you are proposing cuts at the same time 
that you are proposing a supplemental on the same topic.

                           MASKS IN STOCKPILE

    So moving on, how many masks do we need in our strategic 
stockpile and how much will that cost?
    Secretary Azar. So we would need to determine through 
procurement what the cost would be of additional masks. I know 
that this morning in the briefing there was a reference to 
possibly as many as 300 million masks needed in the U.S. for 
healthcare workers.
    We want to define that better through procurement criteria. 
We have to, frankly, establish supply here in the United 
States, ability to manufacture as well as to find sourcing of 
active ingredients such as the filtration, even the nickel and 
copper nose joints that go on the N95 masks.
    Senator Schatz. I got it. So for the----
    Secretary Azar. So if we get--if we get the money we can 
actually make that market and get capacity built here in the 
U.S.
    Senator Schatz. Understood.
    Secretary Azar. We want to work with you on----
    Senator Schatz. But for the $2.5 billion, the masks and the 
strategic stockpile, the test kits, all of your five lines of 
effort, it seems to me you do not quite know how much each line 
of effort is going to cost. Is that accurate?
    Secretary Azar. We would have to do procurements to find 
out exactly what we would--our per unit cost would be on the 
masks----
    Senator Schatz. So that is a yes?
    Secretary Azar  [continuing]. Because, again, we would be 
scaling up domestic production that does not fully exist right 
now. So one does not know until one actually procures those.

                        CORONAVIRUS SUPPLEMENTAL

    Senator Schatz. So how do you get to $2.5 billion not 
knowing how to compile--you have five lines of effort. You do 
not know how much the--the first one I am asking about you say 
you have to go through procurement.
    You have to build a market. I understand all that. So then 
how do you get to $2.5 billion with any degree of specificity 
or reliability? Is $2.5 billion sort of pulled out of a hat?
    Secretary Azar. No, not at all. The $2.5 billion actually 
reflects----
    Senator Schatz. Well, then but one of the major cost items 
you do not know how much it is going to cost.
    Secretary Azar. You do not know the precise per unit cost 
but in the range of the hundreds of millions of dollars we are 
dealing with that, clearly, would be sufficient.
    I think right now acquisition costs for N95 masks tends to 
be under a dollar. So that gives you a rough approximation. But 
we have to scale up domestic production. That might be----
    Senator Schatz. So do you have that--do you have back of 
the envelope numbers that you have not yet provided to the 
committee?
    Secretary Azar. Yes, because I have----
    Senator Schatz. Because it sounds like you have--well, but 
it sounds like you have ballpark numbers. I was told by a staff 
person that the supp--now, I have not gone through it with a 
fine-tooth comb yet but I have been told that this is the least 
detailed supplemental that they have ever seen.
    Secretary Azar. Well, you have--yes.
    Senator Schatz. And so should we just consider this a 
marker and you will get us the details later?
    Secretary Azar. Not in the least. There is a letter that 
went up last night which has the number--the basic numbers in 
it and, as I have told both the chairman and the vice 
chairwoman, we will work with your staffs to get you the 
details behind that. There is detail behind that. Just last 
night you got the initial letter.

                          DIAGNOSTIC TEST KITS

    Senator Schatz. Okay. Final question on test kits. They 
were deployed into a bunch of locations. They did not function 
properly. Why in the world do we have test kits--do we have 
tests that operate in Atlanta but cannot be--and the country of 
Japan has test kits that are reliable.
    Other places--first of all, other States but also other 
countries have operating test kits. And given all of the 
preparedness work that you say you have been doing and all of 
the extraordinary work of all of our agencies, why cannot we 
deploy test kits that function and why does it have to be mid-
March before States and especially ports of entry have 
functioning test kits?
    Secretary Azar. So as I mentioned before, the CDC test was 
developed with historic speed. It has three reagent phases on 
it. The third one, it is unclear whether it is actually 
necessary.
    But what we do whenever it deploys out into the field or at 
CDC one has to do the quality control and validate those 
results. That validation failed at the third stage not for 
false positive or false negative but simply for inconclusive 
results against control in one of the 92 reagent slots. We are 
now----
    Senator Schatz. Thank you, and my--I am sorry----
    Secretary Azar  [continuing]. Working on streamlining that 
process with FDA. So we hope to get those revised ones out very 
quickly.
    Senator Schatz. Thank you.
    Senator Blunt. Thank you, Senator Schatz.
    Senator Kennedy.
    Senator Kennedy. Thank you, Mr. Chairman.
    Thank you, Mr. Secretary, for being here.

                              CORONAVIRUS

    We have 14 active cases now, excluding the 39 that were 
imported.
    Secretary Azar. That is correct. We have 14 and then we, at 
the moment, are at a total of 43 imported. Forty from the 
Diamond Princess, three from Wuhan. Yes.
    Senator Kennedy. How did the 14 contract the virus?
    Secretary Azar. The 14 contracted the virus. Twelve of them 
contracted it by travel in Wuhan, China, and the other two were 
spouses of infected--of those 12.
    Senator Kennedy. How is the virus transmitted?
    Secretary Azar. I do not want to play doctor on this. It is 
transmitted generally by respiratory symptoms. But I would like 
to defer, if I could. We will be happy to get you, from 
scientists, the best assessment of transmissibility of the 
disease.
    Senator Kennedy. Can it be transmitted through food?
    Secretary Azar. We do not believe that there would be 
fomite transmission through food. But we still are trying to 
learn of the sustainability of the virus on surfaces. That is 
what we call fomite transmission is, and Dr. Fauci has said he 
does not believe that there is a reason to believe it should 
survive more than a couple of hours on hard surfaces.
    Senator Kennedy. So it can survive a couple of hours 
outside the body?
    Secretary Azar. That is what Dr. Fauci has said is the 
working assumption. But, of course, we do not have firm trial 
data on that yet. That is one of the things we are hoping to 
learn from the WHO (World Health Organization) team in China.
    Senator Kennedy. How is severity determined?
    Senator Azar. Severity is determined usually by fatality 
rate against the number of people infected.
    Senator Kennedy. Right, obviously. Let me rephrase that. 
That was not a very artful question. Some people get really 
sick. Others do not.
    Secretary Azar. Right.
    Senator Kennedy. Why the difference?
    Secretary Azar. Well, we do not know. That will depend on 
the nature of this disease. For instance, with the 1918 flu, 
the so-called Spanish flu, it was interestingly your healthier 
young middle-aged adult males that seemed to have the worst 
reaction and greatest severity.
    Senator Kennedy. Let me stop you, Doctor.
    Secretary Azar. Yes.
    Senator Kennedy. I do not want to get too far afield here. 
The short answer is we do not know, right?
    Secretary Azar. We do not know right now, no.

                           MASKS IN STOCKPILE

    Senator Kennedy. Okay. How many face masks do we have?
    Secretary Azar. We currently have 30 million N95 
respirators in the Strategic National Stockpile.
    [The information follows:]

    
    

    Senator Kennedy. How many do we need?
    Secretary Azar. Dr. Kadlec mentioned to the Senate this 
morning needing approximately 300 million for healthcare 
workers.
    Senator Kennedy. We have 300 million healthcare workers in 
America, do we?
    Secretary Azar. No, that would be assuming the need to swap 
out used ones.

                       CORONAVIRUS CASE MODELING

    Senator Kennedy. Okay. What do your models show about how 
many cases we are anticipating?
    Secretary Azar. Well, we do not know because we do not know 
the full attack rate in China. So, for instance, we have seen a 
high of 30 percent infection on the Diamond Princess, 
approximately, which was, frankly, seemed to be an incubator.
    In Wuhan, China, it is very hard to know what the total 
accurate number of cases are.
    Senator Kennedy. We do not know then?
    Secretary Azar. We do not know.
    Senator Kennedy. Okay. Do you have models to try to answer 
this question?
    Secretary Azar. Well, we can only extrapolate based on the 
data we get from China at this----
    Senator Kennedy. Is China telling you the truth?
    Secretary Azar. We are getting data from China, as the 
world is. But whether that information is full and transparent 
we just do not know.

                            MORTALITY RATES

    Senator Kennedy. What is the mortality rate of the 
coronavirus?
    Secretary Azar. It is showing right now anywhere between 1 
and 2 percent. But, again, that is based on a denominator. 
There may be many, many more cases in China that are low 
symptomatic or have not secured treatment and, hence, are not 
in the Chinese reported cases.
    Senator Kennedy. What is the mortality rate of influenza?
    Secretary Azar. Seasonal influenza tends to be .1 percent 
mortality.
    Senator Kennedy. Okay. So we are talking about a 
substantially higher mortality rate?
    Secretary Azar. It could be, again, dependent on what that 
denominator is. That is why we need to use great caution in 
making predictions about the severity of this.

                          CORONAVIRUS VACCINE

    Senator Kennedy. How soon will we have a vaccine?
    Secretary Azar. Well, as I mentioned, Dr. Fauci in the Wall 
Street Journal today talked about this going into clinical 
trial, amazingly, within 3 months after discovery. We could, 
within a year, have a vaccine.
    But we want to, through the supplemental, put multiple 
vaccine candidates out there. We have a billion dollars of 
proposed investment in vaccine through the supplemental.
    Senator Kennedy. The secretary of the Department of 
Homeland Security, which is charged with keeping us safe, just 
testified about 10 minutes ago a month and a half. Which is it?
    Secretary Azar. One could not develop a vaccine in a month 
and a half. That would--that has never happened in human 
history.
    Senator Kennedy. Maybe you ought to talk to the secretary 
of Homeland Security before he spreads that too far.
    Are we getting the cooperation that we need from countries 
other than China and, obviously, Iran?
    [Laughter.]
    Secretary Azar. Well, obviously, not Iran. But for other 
countries, yes, we believe so.
    Senator Kennedy. That is all I had, Mr. Chairman.
    Senator Blunt. Thank you, Senator.
    Senator Baldwin.
    Senator Baldwin. Thank you, Mr. Chairman.

                              DRUG PRICING

    Secretary Azar, I want to tell you about a couple of 
constituents. Mary from Franklin, Wisconsin, attended a 
roundtable I had over the President's Recess Week on the price 
of medications, and she worked for Kenosha County for over 20 
years, retiring as a child support caseworker. She has diabetes 
and the cost of her medications including insulin are over 
$1,500 a month.
    She said to me, I am just one of millions of people that 
have this problem. There are people who are not getting their 
medication who are dying because they cannot get their 
medication who are deciding on food or medication or paying 
mortgages.
    At that same roundtable, I met a father whose son--young 
son had a severe allergic reaction. He was treated at the 
hospital and then the physician prescribed epinephrine. Because 
of the child's tender age and weight, an EpiPen was not 
appropriate because it would contain too high of a dose, and 
when he went to fill the alternate prescription that had the 
right dose, the out-of-pocket cost would have been $5,000.
    Now, my--I was in disbelief when I heard that. He explained 
a little bit more, and what he ended up doing was buying an 
EpiPen and praying that his son will gain at least seven pounds 
before he next has any type of allergic reaction. But how 
frightening.
    So in December, the House of Representatives passed a 
comprehensive prescription drug pricing bill that included my 
bipartisan Fair Drug Pricing Act. The Fair Drug Pricing Act, as 
you recall, passed out of the Senate Health, Education, Labor, 
and Pensions Committee last June.
    You noted in your testimony that the budget supports 
bipartisan drug pricing proposals. However, it does not support 
explicitly either the House-passed bill or my bipartisan Fair 
Drug Pricing Act.
    We have talked a lot about transparency in this industry. 
Do you think pricing transparency would make it harder or 
easier for Congress to oversee the drug corporations and enact 
sensible policy that would bring down prices?
    Secretary Azar. We do support notions of drug price 
transparency. In fact, I tried to get--and you all supported 
me, thanks in particular to Senator Durbin's great work--tried 
to get specific authorization to explicitly require that drug 
companies disclose their pricing in their direct to consumer 
advertising and we are now having to, rather astonishingly, 
litigate that issue in courts----
    Senator Baldwin. Yes.
    Secretary Azar  [continuing]. Because the drug companies 
are embarrassingly ashamed to talk about their prices.
    Senator Baldwin. Right. So the drug--a Fair Drug Pricing 
Act would say if you want to raise the price you issue a report 
to your agency with justification and full transparency.
    We talked probably around a year ago about whether we are 
even capable of showing a follow-the-dollar chart when you, 
say, have a drug that is priced right now--list price is set by 
the drug corporation at a hundred dollars what piece does the 
manufacturer take, what piece does the PBM (Pharmacy Benefit 
Managers) take, what piece does everyone along the way take of 
that.
    And then when they double it, how does that change? Where 
does the extra $100 go? We do not even know that, and so I urge 
you to work with us to pass the bipartisan Fair Drug Pricing 
Act. I think it will so help our ability to rein in these 
prices.

                   SHORT-TERM HEALTH INSURANCE PLANS

    In my few seconds left, I want to switch gears and talk 
about the vast expansion of junk plans that has occurred under 
this administration.
    There was a study released just shortly ago that found 
these junk plans impose extraordinary costs on very vulnerable 
populations--those newly diagnosed with cancer.
    According to the study, a patient that is newly diagnosed 
with lymphoma and covered by one of these junk plans could pay 
anywhere from $23,000 to $45,000 in out-of-pocket expenses in 
the first 6 months following their diagnosis.
    The other issue that I wanted to point out is we are 
talking about coronavirus. We just had reporting out of Florida 
that somebody who had recently traveled to China presented for 
concerns that he might have contracted the coronavirus may be 
charged thousands of dollars in out-of-pocket costs for seeking 
care because he is covered by a junk plan.
    How does the expansion of junk plans by this administration 
help us during severe outbreaks like the one we are currently 
experiencing and is very frightening as the--as we move forward 
and how does it help somebody who incurs cancer, who is 
diagnosed with cancer?
    Secretary Azar. So short-term limited duration plans are 
not right for everyone. We have been very transparent about 
that, and they existed under the Obama administration at the--
--
    Senator Baldwin. They were 3 months. Now they are 3 years.
    Secretary Azar. Actually, no. At the--in a midnight----
    Senator Baldwin. You are right.
    Secretary Azar. In a midnight regulation, they shortened 
them to 3 months and we restored that. They are not right for 
everyone.
    Senator Baldwin. Because of the impact on the rest of the 
market.
    Secretary Azar. Well, they are not right for everybody and 
we have enhanced actually the consumer protection notices, even 
from what the Obama administration had.
    But some insurance for some people might be better than not 
being able to afford any insurance. These are 60 percent off 
and cheaper than Affordable Care Act plans for people who are 
not subsidized. So it is an option but it is not the right 
option for everybody and we have tried to be very transparent 
about that.
    Senator Blunt. Thank you, Senator Baldwin.
    Senator Rubio.

                              CORONAVIRUS

    Senator Rubio. First, I want to acknowledge how difficult 
this issue has been because of where it originated, in China. 
They are less than transparent. Whatever numbers they put out 
every day I can assure you the numbers are higher as to the 
actual number of cases.
    But to date, at least unless they shared it with the World 
Health Organization, they have not shared the original viral 
sample.
    I know they put the code up online but they did not share 
the sample. They have not really been forthcoming about best 
practices on a host of issues.
    Our response is complicated by the fact that we are dealing 
with a totalitarian government that is more interested, 
apparently, in PR (Public Relations) and in their image than 
they are in actually dealing with this the way we would if we 
had an outbreak of this kind. That is most certainly impeding 
our ability to develop things like a vaccine and so forth.
    Secretary Azar. We need full transparency and full 
cooperation from China as well as every country, and the WHO 
needs to hold every country accountable as they would the 
United States for that type of transparency and cooperation.

               CORONAVIRUS EFFECTS ON DEVELOPING NATIONS

    Senator Rubio. Well, the second question is have we done 
any estimates or do you have any view on what would happen if 
this virus makes itself to a underdeveloped country with poor 
or no public health, for example, Haiti or Central America, and 
some nations in Central America, in particular?
    The impact that would have on those societies, not to 
mention many nations in the African continent, what it would 
mean for migration flows, for the global economy.
    Have we viewed--have we--do you have any thoughts about how 
destructive it would be. One thing is that it shows up in Italy 
or the Canary Islands or--another thing is that is shows up in 
a country that already lacks any sort of basic public health 
and the ability to address it.
    Secretary Azar. Obviously, it would be very concerning if 
this virus spreads, say, to Africa or other areas that have 
less developed public health infrastructure because they won't 
be able to take the steps towards mitigation and containment 
that we can take here in the United States.
    And so it would spread quite rapidly. This is why it is 
actually so critical to get better data out of China so that we 
know the severity and the--what the mortality rates really are 
here so we know what we are dealing with in terms of impact.

                        PHARMACEUTICAL SHORTAGES

    Senator Rubio. Now, we know that 80 percent of active 
pharmaceutical ingredients in the United States come from 
China, and I wrote a letter about this to the FDA commissioner. 
And I know there is a lot going on but we have yet gotten a 
response.
    So I wanted to know a few things. Does the FDA have tools 
and information to track potential medical device or 
pharmaceutical shortages?
    Secretary Azar. We do under FDASIA (Food and Drug 
Administration Safety and Innovation Act) for--to be able to 
track with pharmaceuticals. They have to report to us if there 
is any potential shortage and we have not received any 
reporting yet about potential shortages connected to the China 
situation.
    The medical device companies do not have to make those same 
kinds of proactive reports and that is actually part of what we 
have suggested in legislation.
    Senator Rubio. What can we do or what would we do to 
mitigate shortages of particularly critical medicines if in 
fact we saw one coming?
    Secretary Azar. It is a very difficult challenge because 
the supply chains with drugs as with the rest of our economy 
are very much globalized and entwined with China and elsewhere 
and one does not--one cannot stand up a manufacturing facility 
for pharmaceuticals just overnight.
    And so if a drug company happened to have multiple 
manufacturing facilities that were qualified we would--they 
could transfer their manufacturing and we would certainly work 
at FDA to expedite any type of inspection regulatory approval 
to support that.
    Senator Rubio. Well, have we coordinated with any non-
Chinese suppliers of products at least in an effort to sort of 
think forward about what we would do if in fact suddenly we 
face--again, we are not dealing with the most transparent 
government in the world in China.
    So if this thing came upon us fairly quickly what option 
would we have to work with non-Chinese suppliers of these key 
ingredients?
    Secretary Azar. Well, we can work with any supplier that is 
FDA approved. One cannot just secure FDA approval overnight for 
either a generic ANDA (abbreviated new drug application) or for 
the manufacturer, of course, of an innovative product. And so 
we would work with those companies that hold licensing and hold 
patent rights to be able to expand their--in this country.
    Senator Rubio. But have we done any work just sort of 
putting some of that in place just in case this comes on 
quickly?
    Secretary Azar. Well, we are aggressively and proactively 
working with all of the drug companies and device companies and 
we have made it clear we are available to help them.
    None of them has singled any potential problems in terms of 
supply. There are a couple manufacturers that do work in Hubei 
Province, the epicenter. But they report that they have large 
stockpiles of supply already--of product already.
    But we are aggressively working on this because it is a 
concern when one has this global supply chain that is 
intermingled throughout the world including in China.
    Senator Rubio. Just as a last point, I think this instance 
calls to mind that perhaps it is not the greatest idea for the 
health--for Americans in need of healthcare to have 80 percent 
of our active ingredients come from one place in the world 
where it can potentially serve as strategic leverage at some 
point down in the future but is vulnerable to this sort of 
disruption.
    At a minimum, you would agree that this is sort of a wakeup 
call that perhaps we are overly dependent on the supply chain 
so heavily concentrated in one place in the world?
    Secretary Azar. It is and has been, and you have been at 
the forefront of calling attention to this issue. The challenge 
is what the appropriate remedies are for that because if we 
start dictating where companies make product, that could 
increase costs, which would increase healthcare, and drug costs 
in the United States.
    But we are happy to work with you and Congress on if there 
are supply chain management approaches that we should take that 
are more directive than Congress would want to authorize.
    Senator Alexander [presiding]. Thank you, Senator Rubio.
    Senator Murphy.

                          CORONAVIRUS RESPONSE

    Senator Murphy. Thank you very much. Good morning, Mr. 
Secretary.
    We can agree that when you are dealing with a response to a 
pandemic days and weeks matter, correct?
    Secretary Azar. We try to take advantage of every day we 
have been able to buy through our aggressive containment 
efforts and our public health response, absolutely.
    Senator Murphy. You presented a briefing to members of the 
Senate 3 weeks ago in which many of us expressed alarm that the 
administration had not sent a supplemental request to Congress 
at the outset of this epidemic.
    We were told in that briefing that the administration 
believed that it had ample existing resources to handle this 
epidemic. That did not make sense to many of us who saw what 
was coming.
    Last night, you sent word that you are now requesting that 
supplemental funding and we are hopeful to get some meat put on 
the bone so that we can get to work very quickly. That was a 
mistake now in retrospect to not request that funding weeks ago 
at the beginning of this pandemic, correct?
    Secretary Azar. No, not at all. We had $105 million that we 
are spending from the Infectious Disease Rapid Response Fund. 
We have not even started on the $136 million from the transfer 
authority that I have sent over to--I think last night we sent 
notice of the reprogramming and transfer plans that we have for 
that.
    Three weeks ago was just 2 weeks into even knowing about 
this virus, which we have been very transparent, we are 
briefing and working with you on.
    One cannot know the contours or nature of the disease or 
its progression to even know what to request at that point and 
what that would involve and, indeed, today we have seen one of 
your colleagues was questioning if we even know enough to make 
a request at this point.
    And so we are making the request. We believe we know enough 
to do that now. We have not run out of money.
    Senator Murphy. Well, I think his point was in response to 
your statement regarding your inability to create a market 
until you have the funding, which speaks to the long process 
from the request of funding to Congress to the creation of a 
market that would answer some of the concerns that Senator 
Rubio has.
    And so what was knowable 3 weeks ago is that when you make 
a request of Congress the money does not occur and be created 
overnight.
    It is a process to come up with that legislation, and then 
you acknowledge yourself that even once you get that funding 
you then need to go out and create markets for some of the 
products that have shortages.
    And so many of us did see the need early on because we knew 
that it would take a long time in order to get this funding 
through the process and I think we have lost critical days and 
weeks, and there were many people in that briefing who were 
asking you to present this earlier.

                         GLOBAL HEALTH SECURITY

    Can I ask you about a program that the CDC was running I 
think, largely, with previous supplemental dollars that was--I 
have heard it referred to as an epidemic prevention account, 
Global Health Security Initiative, operating in about 50 
countries.
    Reports from about a year and a half ago suggest that as 
that money ran out and the CDC did not replace it with other 
funds, the number of countries in which we were forward 
deployed trying to train local public health staffs to identify 
pandemics and respond to them were reduced from 49 countries to 
10 countries.
    At the time, you received a letter from about 200 different 
public health organizations asking you to back fill and request 
new resources to make sure that those programs remained open.
    You may not have an answer today. But can you confirm that 
that program is only running today in 10 countries compared to 
the 49 that it was running in--when that supplemental funding 
was still available?
    Secretary Azar. So what has happened is the--as the Ebola 
supplemental money was going down we were increasing the Global 
Health Security agenda funding through CDC. So, for instance, 
for 2021 appropriation we have requested $175 million, which is 
a $50 million increase there as we slope that up.
    In terms of the countries, we are very committed to the 
Global Health Security agenda, as are you. The number of 
countries--our focus has moved to try to have a regional 
footprint and also to--as we have built labs and built 
capacities in countries, they stand on their own and we moved 
to other countries or moved our regional approach.
    We can get you the precise countries where we are operating 
in now. But that has been the philosophy. It has not been a 
retrenchment. It has, though, been to have a regional 
deployable force instead of permanent infrastructure in every 
single country.
    Senator Murphy. The chairman is not here but I think the 
answer is that we are operating today in perhaps one-fifth the 
number of countries that we were several years ago and we were 
operating in 50 countries because we recognized we had a lot of 
work to do to train up staffs, especially in developing 
countries, to identify these outbreaks and treat them at the 
outset so they did not ultimately reach our shores.
    And many of us have been, I think, sounding this alarm for 
years that budget cut after budget cut, proposed budget cut 
after proposed budget cut to the CDC was going to have an 
effect.
    And I do not think today we can draw a straight line 
between the number of countries that have been cleaved off of 
this global pandemic prevention program and the outbreak that 
we are dealing with today.
    But it is another alarm bell for us. We cannot continue to 
close our eyes to these developing pandemics. We are going to 
have to be partnering with many other countries and under this 
administration, unfortunately, we are going the wrong way. We 
are operating in less countries abroad, not more countries.
    But I will appreciate hearing the more detailed information 
from you in the coming days.
    Senator Alexander. Thank you, Senator Murphy.
    Senator Hyde-Smith.
    Senator Hyde-Smith. Thank you, Mr. Chairman.

                        LIVER ALLOCATION POLICY

    Secretary Azar, thank you so much for being here today and 
I want to start by making a few comments before I go to my 
question.
    First, I know you have heard from Chairman Blunt repeatedly 
about his concerns regarding the allocation of livers for 
transplant.
    I share the chairman's concerns. Our only transplant 
program in Mississippi at the University of Mississippi Medical 
Center just completed its 250th liver transplant this past 
Friday, which is a very important milestone for us.
    Since the program started in 2013, it has meant so much to 
critically ill Mississippians to be able to get this lifesaving 
care close to home and I am worried now the new liver policy 
will undercut that UMMC (University of Mississippi Medical 
Center) program.
    I hope you will work with us to address these concerns and 
ensure the continued viability of new liver transplant programs 
just like the ones that we have in Mississippi.

                               DRUG COSTS

    Secondly, I want to thank you for your focus on lowering 
the cost of prescription drugs for all Americans. Whenever I am 
in Mississippi, I constantly hear from constituents who are 
concerned about high out-of-pocket costs for their prescription 
drugs. But both you and the president have made this a issue of 
priority and I certainly thank you for that.

                               TELEHEALTH

    Third, I was very pleased to see your budget request 
include legislative provisions from the Connect for Health Act 
to help expand telehealth at community health centers, rural 
health clinics, and Indian Health Services facilities.
    As one of the six senators on the Senate Telehealth Working 
Group, I was very glad to be able to introduce this bill and I 
am working to get it enacted into law. Your support is 
extremely critical in that.

                            RURAL HOSPITALS

    At this hearing last year, you and I discussed struggling 
rural hospitals in Mississippi. This continues to be a problem 
not only in my State but across the Nation.
    The most recent data just released from 2019 shows that 
nearly 50 percent of rural hospitals are still operating in the 
red.
    Last year, I was so pleased when you testified that, in 
part, because of some efforts from my office you had 
established a Rural Health Task Force at HHS to find all ideas 
to help address the crisis in access in rural America.
    I have also been pleased to support some of the early work 
on the task force including changes to the Medicare wage index 
that meant so much to our rural hospitals in Mississippi.
    But I know the task force has been working very hard in 
recent months to do even more. Can you provide us with an 
update on the task force work and, specifically, how this 
subcommittee can help support you and your office in that?
    Secretary Azar. Thank you, Senator.
    And yes, on the Rural Task Force we have now matured into 
the point that rural healthcare is a centerpiece of the 
president's healthcare agenda and a centerpiece on the budget 
proposals.
    There are really four pillars to it. The first is rural 
healthcare has to have a sustainable business model. We cannot 
just patch over it. It has to be something that economically 
works in our rural communities.
    Second, we have to have prevention and health promotion in 
rural communities.
    Third, we have to take advantage of telehealth and other 
innovation, and fourth, we need health professionals such as 
PAs--physician assistants--nurse practitioners, and others who 
are able to practice at the full extent of their training and 
licensure in these rural communities where we cannot often find 
just doctors to practice.
    So we have many proposals in the budget. One of them which 
I am very excited about that would help with rural hospital 
closures would allow critical access hospitals to convert to 
emergency facilities with an emergency room and outpatient and 
not have to bear the burden of continuing inpatient bed 
facilities, and also get payment supplements on that.
    So I think that could be a real lifeline to our rural 
communities if we can get that approved. We also have several 
provisions we have proposed on expanding access to telehealth 
and compensation both in rural America but also in Indian 
Country for facilities there.
    And then we also want to modernize our payment for rural 
health clinics because our community health centers in rural 
health areas, in rural areas, can be an important backbone of 
our system also.
    So we have got a whole suite of legislative proposals in 
there for rural health and combined with our budget increases 
that we would love to work with you on.
    Senator Hyde-Smith. Thank you very much.
    Senator Alexander. Thank you, Senator Hyde-Smith.
    Senator Shaheen.
    Senator Shaheen. Thank you, Mr. Chairman.

                          CORONAVIRUS BRIEFING

    Secretary Azar, thank you for being here. I do not have any 
questions about the coronavirus because I was at the briefing 
this morning and I appreciated your comments to clarify some 
things.
    The question that I have for you and whoever else in the 
administration or in the Senate is why that briefing was 
closed. I have met with a number of constituents--in fact, 
right after the briefing--who were very concerned that they did 
not have information, and I think it would be very helpful to 
the public to be able to hear what is being said, and I did not 
hear anything this morning that I have not read in the 
newspaper already.
    So I think to have some of those briefings open so the 
public can hear them would be a great benefit and I hope there 
will be something on websites to help companies prepare their 
employees to help the public understand what is going on.
    So I give that to you to take back.
    Secretary Azar. And, actually, if I might, my understanding 
is Chairman Burr, the chairman of the Senate Intelligence 
Committee, asked that that briefing be held at the top secret 
level to ensure complete transparency with members of the 
Senate on any information.
    I think what was found was in the discussion we are not 
relying on classified information.
    Senator Shaheen. Right.
    Secretary Azar. We have tried to have radical transparency. 
And so I think by the end of it, it was realized nothing 
classified had been discussed and so that label was taken off 
of it.
    But yes, we have tried to be completely transparent about 
what we know so and we----
    Senator Shaheen. I think that would be helpful.
    Secretary Azar  [continuing]. Absolutely support that kind 
of public disclosure----
    Senator Shaheen. And I do not want to cut you off but I am 
about out of time. So my clock is running.

                             MEDICAID CUTS

    New Hampshire has been really hard hit by the opioid 
epidemic, as you know, and it has become very clear that the 
Medicaid expansion has been our best tool in combating the 
epidemic.
    According to the most recent data available, 23,000 Granite 
Staters have accessed substance use disorder treatment through 
the Medicaid expansion.
    But your HHS budget proposal would slash Medicaid funding 
by $920 billion, including $744 billion in cuts that appear to 
gut the Medicaid expansion.
    On page 112 of your budget it says that, and I quote, ``As 
part of the president's health reform vision, Medicaid spending 
will grow at a more sustainable rate by ending the financial 
bias that currently favors able-bodied working adults,'' end 
quote.
    So the only way I can read that is that you are suggesting 
that Congress should eliminate the match that are--is currently 
provided to States who participate in the Medicaid expansion. 
Am I reading that correctly?
    Secretary Azar. We do believe--I have said this for a 
couple years--that the enhanced match for Medicaid expansion 
for able-bodied adults actually prejudices against pregnant 
women, children, aged, blind, and disabled in traditional 
Medicaid and we think that needs to be corrected.
    So yes, you are reading that correctly.
    Senator Shaheen. And so are you suggesting that we should 
eliminate the match that can go to Medicaid expansion for 
States to use for treatment for substance use disorders, for 
example?
    Secretary Azar. So what we have suggested in the budget is 
an allowance that would have us work with Congress to look at 
issues like that around what is the appropriate Federal 
matching rate for expansion compared to traditional Medicaid 
populations and what is a sustainable growth in that expansion 
population as well as what flexibility States would require.
    So it is meant to be collaborative with--working with 
Congress. But there is a problem here, which is there is a real 
prejudice in the Medicaid system now in favor of able-bodied 
adults and State support of them because of the 90 percent 
match versus the average 60 percent Federal match for those 
core traditional populations of Medicaid like pregnant women, 
children, aged, and blind and disabled there. It is a real 
disparity in the system that we need to address.
    Senator Shaheen. Well, I hear that. To address it in a way 
that would eliminate the match certainly puts at risk those 
thousands of people in States like New Hampshire, across this 
country, where they are getting their treatment for opioid 
disorders and without that Medicaid they would not be getting 
treatment. There is no alternative in a place like--in States 
like New Hampshire for providing that treatment.
    So I am not going to ask you to comment on that. But just--
I hope that that is something that you will think about and you 
will share with States like New Hampshire before making any 
changes, and I am sure Congress will want to weigh in.
    Secretary Azar. And I do not believe we have suggested 
eliminate but, rather, regularizing it compared to traditional 
Medicaid.

                        E-CIGARETTES AND VAPING

    Senator Shaheen. I want to go now to the issue with e-
cigarettes and vaping because I have been very disappointed at 
the flip flop that we have really seen from the FDA and from 
the effort to try and scale back on what e-vaping products are 
available to young people and to the public.
    And, you know, I thought initially the FDA was pretty clear 
that it was going to take all flavored vaping products off the 
market, including menthol, and yet they have failed to do that.
    So I wonder if you can talk about what you are seeing in 
addressing vaping.
    Secretary Azar. So I share your passion on the e-cigarette 
challenge and keeping these away from kids. Just to explain why 
there was a change in what we initially announced in September 
the 11th, we, with our original data set that we had, which was 
the National Youth Tobacco Survey, had tobacco flavor in one 
category and mint and menthol together, showing mint and 
menthol as a group was being used by kids.
    That actually troubled our public health people because we 
have significant menthol combustible users and want to make 
sure there is an exit avenue for them that is available.
    We then got after the announcement the Monitoring the 
Future Survey that finally gave us a breakdown of mint and 
menthol showing it was really mint driving it and menthol was 
comparable to tobacco flavors.
    And so we were able to leave menthol on the market, go 
after the mint there, and so that was the basis for why we made 
that change.
    Senator Shaheen. Well, my time is up. But as I am sure you 
know, there is legislation that would mirror what is in the 
budget with respect to fees on e-cigarette companies and I hope 
that we can enact that as part of the budget this year.
    Secretary Azar. And we support that also.
    Senator Shaheen. Thank you.
    Senator Alexander. Thank you, Senator Shaheen.
    We will go to Senator Merkley. But on your comment about 
the briefing this morning, as the secretary said, the request 
for a briefing--a top secret briefing was made at the request 
of the chairman of the Intelligence Committee and other 
senators who wanted to make sure that senators knew there were 
not any secrets we were not being told.
    And we were both there, but as a result of that I think 
what we learned was that everything we were told had already 
been available to the public. So that was the motive. That was 
the motive for it.
    Senator Merkley.
    Senator Merkley. Thank you, Mr. Chairman, and welcome, Mr. 
Secretary.

                      UNACCOMPANIED ALIEN CHILDREN

    The administration has proposed a rule that would scrap the 
Flores agreement that sets humanitarian standards for the 
treatment of refugee children, and one of those changes instead 
of requiring 72 hours to move a child to the least restrictive 
setting would allow the indefinite detention of a child. Is not 
indefinite imprisonment of a child a human rights abuse?
    Secretary Azar. So, Senator, I appreciate your concern 
there. That would be a DHS (Department of Homeland Security) 
regulation. The HHS Flores regulation, I believe, largely 
tracks our requirements under the Flores settlement agreement. 
So I can speak to that. I cannot really speak to the DHS 
regulation.
    Senator Merkley. Well, okay. We will leave that there then 
but I will follow up with you.
    I want to switch to--when my team alerted your team I was 
going to ask you about a situation where a child has been 
trapped in ORR's (Office of Refugee Resettlement) custody for 6 
years now, and originally it was approved for her to go to live 
with her aunt in 2014.
    She finally, after 6 years, signed an agreement to be 
deported, without ever being informed that her family, extended 
family, was still waiting and happy to accommodate her.
    Many things about this bother me. But one is that 6 years 
in detention is an incredible impact on a child. Just it is a 
whole childhood disrupted or destroyed.
    Second is that essentially by not informing her that her 
family wanted her it was extraordinarily misleading on top of 
everything else she has gone through. She should have at least 
had the basic information for that decision.
    I am not asking you to comment on this individual case. But 
I am asking you, outside of this hearing, to put this case on 
the top of your stack. Because there is just every now and then 
a situation arises that is so horrific where someone has fell 
between the cracks and been treated in such a manner that none 
of us would want this for anyone we know or any child anywhere 
at any time.
    Would you be willing to take a close look at this case and 
try to make sure that we do not continue this--that we get 
some, perhaps, really high-level attention and fair treatment 
for this child?
    Secretary Azar. Absolutely. In fact, thank you. I am glad 
you--I had not seen the media report until you and your staff 
raised this to us about this and I, of course, validate 
anything in the media report.
    But I have asked the team. I want to dig in on this one, 
find out what is going on. I completely agree with you. We 
certainly do not ever want a child to be with us for that 
length of time.
    But there are sometimes--and I cannot speak to this 
individual circumstance--there are cases where sometimes there 
either is not family, family may not be willing to take someone 
in.
    There may be an unsuitability there. But the shorter time a 
kid is with us--we have talked about this before--the better it 
is for the child and we want kids with us for as short a time 
as humanly possible, consistent with their safety.
    So I will dig in on that personally to find out. I want to 
make sure she is treated fairly and her family is treated 
fairly.
    Senator Merkley. I would like to be able to get weekly 
updates on where this case stands, if that is something you can 
commit to.
    Secretary Azar. I want to make sure I am able to do that 
consistent with the child's privacy, individual rights here. 
But we will work to get you as transparent information as we 
can about her situation because I do want to make sure she is 
treated well.
    Senator Merkley. Okay. I wanted to turn back to the Flores 
agreement. One of the proposed rule features in addition to 
indefinite imprisonment is to replace a hearing before a 
Department of Justice immigration judge with a hearing before 
an HHS officer but only if the child requests it.
    How would any child ever know that they could request such 
a hearing?
    Secretary Azar. Well, all of our kids have the right to 
legal counsel and I believe there actually are phone banks as 
part of the counseling and case management process at the 
grantee facilities to ensure connectivity with counsel.
    This is one of the changes that was made in the regulation 
compared to the way it is set up in the Flores agreement and I 
believe it has to do with a modification.
    We can get you more information about this, but a 
modification in terms of the Justice Department and what they 
believe they are actually legally able to do in terms of 
administering hearings.
    But we are happy to get you more information about that. It 
was not--it really was, I think, just a response to where DOJ 
(Department of Justice) felt they had to be on these hearing 
processes.
    Senator Merkley. Okay. I have visited the children in 
internment camps, I have visited the children in the child 
prisons, and they have no idea that they would have this kind 
of right. Most of them did not have access to counsel.
    Many of them do not speak the same language. You know, it 
is a fantasy to think a child would, except in rare 
circumstances, know to request such a hearing. So that disturbs 
me because it strips a fundamental protection in the system 
away from these children.
    My time is expiring so I will just note this is the thing 
that the Flores settlement said it could be replaced by a 
regulation that implements the Flores settlement. But this 
regulation crushes it, strips it, scraps it, shreds it. It does 
not implement it
    And thus, as you could imagine, on behalf of these refugee 
children, I will be opposing it in every possible way and I 
hope that as you study it you might come to the same point of 
view. Thanks.
    Senator Alexander. Thank you, Senator Merkley.
    Mr. Secretary, Senator has indicated we should go ahead and 
wrap up the hearing at this point, which I will do in just a 
moment. But I want to ask you a question and make a couple of 
comments and then we will conclude the hearing.

                       LOWERING HEALTHCARE COSTS

    You are familiar with the lower healthcare costs bill that 
passed the HELP committee 20 to 3 and I think you are very well 
aware that the House Energy and Commerce Committee and the HELP 
committee worked on an agreement and we pretty well came 
together between the House and the Senate committees on a 
version of that bill, which includes ending surprise billing, 
and about 40 more provisions that would lower healthcare costs, 
focusing on competition, transparency, and prescription drugs 
costs.
    The House Education and Workforce Committee, chaired by 
Bobby Scott with Virginia Foxx, the ranking member, came up 
with basically a similar proposal. And now the Ways and Means 
Committee in the House has also come up with a version that is 
a little different on ending surprise billing.
    So we have two House committees and the HELP committee in 
agreement. We have the Ways and Means Committee headed in the 
same direction. We have the president's support, which is the 
question I am coming to.
    So when you have the HELP committee 20 to 3--it was the 
chairman and Senator Murray--when you have Chairman Pallone and 
Ranking Member Walden, when you have Bobby Scott and Virginia 
Foxx all agreeing with the president's support and you have the 
Ways and Means Committee headed in the same direction, it seems 
to me that is a good candidate for action to lower healthcare 
costs, especially since ending surprise billing, the other 40 
provisions or so that would encourage competition, 
transparency, and lower drug costs and save enough money to 
fully fund community health centers for 5 years, that could all 
be done by the end of May when the community health center 
funding expires.
    So my question for you, is this high on the president's 
priority list and will you continue to work with this committee 
and the three House committees to get a result on ending 
surprise billing, which includes the air ambulance and other 
provisions as well as the community mental health centers--
community health centers?
    Secretary Azar. This is the--so as you know, this is a very 
high priority for the president--ending surprise medical 
bills--and we are very happy that we actually have consensus 
about the core, which is protecting the patient from surprise 
medical bills.
    And what we are just trying to do is work with the 
committees on who then bears that cost--insurers, providers, 
hospitals, et cetera, on the back side, and we want to work 
with you to try to bridge that because you are right, it does 
need to get through. We want to get a bipartisan bicameral 
solution passed.
    Senator Alexander. Thank you, and now here are my comments, 
and you do not need to respond to these if you do not want. I 
see the chairman is here and I will let him have his own 
committee back. But he made the mistake of giving me the chair.

                   PATIENT ACCESS AND PATIENT PRIVACY

    So genomic information of newborn babies--blood taken from 
them--is used, importantly, in research and many members think 
that parents ought to give informed consent to that.
    Some of the researchers are afraid that will limit the 
opportunity for research. My own view is I think the 
researchers are wrong about that. I think when parents go into 
the hospital and fill out all their forms and one of the forms 
says can the blood that we get from your newborn baby be used 
for research I think overwhelmingly they are going to agree to 
that.
    And I would hope you would take a look at that and try to 
help us balance the privacy right and the research opportunity. 
I think it helps the researchers to go ahead and do this 
because that locks in the steady supply of that blood for 
research and avoids coming up and having a big problem with it 
sometime later.
    And the other issue was interoperability. We dealt with 
that over in our authorizing committee. We had a whole lot of 
hearings about medical information blocking, and make it easier 
for patients to get their own healthcare data.
    And the two things I would like to ask you to focus on is 
the one area where we had a lot of concern had to do with 
third-party people getting information from these things 
without us thinking about that very much.
    And the final rules need to balance patient access and the 
privacy that needs to be addressed. In other words, we did not 
think the existing Federal rules really dealt with that issue 
very expertly.
    We want to go ahead and give patients that access but we 
want to make sure that we deal with the privacy question. And 
then the other--and this is my own bias about interoperability.
    I tried to get the Obama administration to slow down on 
implementing the various rules, and expanding about medical 
healthcare information because I thought it involved too many 
people and they were going too fast. We all want to get to the 
same place.
    So I hope that you will not try to do too much too fast. I 
think our goal with the interoperability is to get there. But 
if we try to go too fast to get there we may create more 
problems than we solve.
    So that is just admonitions from having dealt with this for 
several years. I just wanted to take this opportunity to 
mention those two issues to you.
    Now, I will ask the Chairman if he wants to have his 
committee back.
    Senator Blunt [presiding]. Let us see. I think I got the 
critical information.
    Senator Alexander. Yes, and thank him for----
    Senator Blunt. Maybe not. I think I am good.
    Senator Alexander. No, I do--yes, I do have critical.
    Senator Blunt. Thank you, Senator Alexander.
    Senator Alexander. My pleasure, Senator Blunt.
    Senator Blunt. Well, if you were going to pick any 
individual on our committee who had a wide enough range of 
interest to keep you answering questions for the time everybody 
was gone, you would start with Senator Alexander.
    So thank you. We got a few people that may come back. We 
are not going to go a whole lot longer here, Secretary.

                             MENTAL HEALTH

    Let me talk a little about mental health. One of the things 
I have been interested in, as you know, is trying to get mental 
health on a truly even basis with all other kinds of health.
    We have a pilot program that Senator Stabenow and I worked 
on establishing a few years ago in eight States. The fiscal 
year 2020 bill included $200 million for certified community 
behavioral health clinics to support this pilot.
    You have actually proposed that that be increased by $25 
million. I was pleased to see that increase. Also, something 
that we asked for in that bill was more information about what 
changes we are seeing in overall health costs when people's 
mental health is being treated like all other health.
    My goal with this pilot was not to have the Federal 
Government takeover mental health but to try to create the kind 
of whole health information that would make it easier for 
States to determine what this really meant.
    Are they spending no money extra when they treat mental 
health like all other health, which I think may be possible? 
Are they saving money, which may be possible, or are they 
spending only a little more money when they treat mental health 
like all other health?
    It has just always seemed, Mr. Secretary, totally logical 
to me that if you are dealing with somebody's mental health 
problem that you are more likely to be able to deal with any 
other health problem they have in a much more cost effective 
way.
    I do know that on the opioid effort in our State and the 
other seven States that have Excellence in Mental Health pilots 
that the ability to have mental health assistance unlimited by 
14 days or 7 days or whatever it would have been is certainly 
making a difference in people's ability to deal with their 
opioid problem.
    If you do not have a mental health problem when you become 
addicted to drugs, you certainly have one after you become 
addicted.
    So what I really need from you all is as quick a response 
as you can give. We ask for a response to that in 30 days.
    It has been about 67 days, I think, now. But the reason 
that I would like to see that is to see if we are headed in the 
right direction and if there is another way we need to be 
compiling information so that you and I both have, and the 
Congress and State governments have, what they need to look at 
to know the difference it really makes.
    Do you want to respond to that a little bit?
    Secretary Azar. We certainly agree that taking care of 
mental health is critical to overall health, and we will work 
on getting you that information as soon as possible.
    As you know, and I think you alluded to this, the 
president's budget proposes a major change here, which would be 
to lift the IMD (Medicaid Institutions for Mental Disease) 
exclusion at a State option for serious mental illness of 
inpatient mental health facilities beyond the current IMD 
limit.
    And so as we have done for substance use disorder but 
actually make it a State option to get into that, and that 
would make so that I think it would then be exempted from 
budged neutrality and some other restrictions that we have.
    So very excited about that possible change for mental 
health in the United States.
    Senator Blunt. Thank you.

                        ENDING THE HIV EPIDEMIC

    I do not know if you have had a chance to talk about the 
president's HIV initiative much today with everything else that 
is going on. But we did fully fund--Senator Murray and I worked 
together with our colleagues in the House to fully fund the 
request last year.
    What kind of progress are you making there in the End HIV 
Initiative and what should we be thinking about, as we look at 
the number you asked for this year?
    Secretary Azar. So what we did up until the appropriation 
came out in December was supporting in the target counties the 
preparation activities. So we have got, of course, most of your 
new--half of our new cases are occurring in 57 target 
jurisdictions and so we worked there to get their plans in 
place and ready.
    We had four jump-start jurisdictions that we were able to 
start moving on. Now that you funded it, we are now actually 
implementing the initiative in terms of diagnosing, treating, 
preventing, and responding.
    The new money, so for 2021 would be year two of the full 
initiative, and that would be $716 million for year two. That 
is just the scale up--the $450 million scale up as we know 
implement those plans.
    So that is expanding for the community health centers that 
are in the 57-target jurisdictions, expanding their ability to 
treat as well as to prescribe PrEP (Pre-Exposure Prophylaxis) 
and get people on PrEP.
    It involves outreach to individuals and adherence programs 
to ensure people take their PrEP and get on it, stay on it, and 
that individuals who are diagnosed get on their anti-
retrovirals, expanding Ryan White capabilities in the target 
jurisdictions, also at CDC having the Rapid Response Team able 
to go and deploy into clusters where we see new clusters of 
HIV--of HIV coming out.
    So, really, across that at CDC and HRSA is now its 
implementation. So with the money you got us in December, we 
are beginning that State-by-State implementation and this would 
be the second year with just full-scale up into that.
    Senator Blunt. So in a meeting yesterday in my office where 
the topic came up on HIV, if you had said get on PrEP and stay 
on it, would this be an area where some kind of time-released 
medication where you took it once a week or once a month and it 
released on its own would have some real potential?
    Secretary Azar. Certainly, any kind of long acting on PrEP 
would be great. I do not know if the manufacturers are pursuing 
that. I have not seen if that is a formulation that they are 
working on. But yes, you would see--if you saw monthly, for 
instance, that would be fantastic.
    Senator Blunt. Yes.
    Senator Durbin.
    Senator Durbin. Thanks, Mr. Chairman.
    Dr. Azar, thank you for your patience in waiting with the 
roll calls.

                        E-CIGARETTES AND VAPING

    You and I have had so many good conversations about the 
issue of vaping and e-cigarettes. The President and First Lady, 
in the Oval Office in mid-September of last year, made some 
very strong encouraging statements about dealing with this.
    Unfortunately, a few months later when the policy was 
announced there were some things in there that concerned me. 
The president's promise to remove all flavored e-cigarette 
products from the market within a matter of weeks did not 
happen.
    Instead, the president decided to exempt cheap disposable 
e-cigarettes like Mr. Fog's bubble gum flavor, Puff--I cannot 
keep up with the names of these things--Puff Bar's O.M.G. 
flavor, and Stig's Mango Bomb flavor, not necessarily a product 
for people who are hardened smokers trying to quit.
    It is a product to attract kids, and over 80 percent of 
kids are attracted to that kind of junk and end up with a 
nicotine addiction.
    I think it was a mistake to exempt these cheap disposable 
products from the president's so-called flavor ban. I am 
concerned about his decision to exempt more than 15,000 flavors 
in the open tank vaping system.
    I would like to get on the record what you have told me 
personally and privately about monitoring what is going to 
happen next and what the response would be from you and the FDA 
if it turns out that the extent of the ban, the extent of the 
restrictions are not adequate to stop this youth epidemic.
    Secretary Azar. Yes. First, Senator Durbin, thank you for 
your partnership on the e-cigarette issue. You have been--
really, it has been wonderful to work with you to just keep 
this focus on keeping these e-cigarettes away from children.
    In terms of the disposables, as we talked about, NJOY, 
which I believe is the largest disposable manufacturer, did 
pull of its flavored disposable products from the marketplace, 
respecting the spirit of what we were trying to do here.
    These other products, if they are targeted at kids and as 
we get--if we get data showing that they are--that kids are 
using these products we are going to go after them with 
enforcement with the full weight that we have got.
    We have even talked to companies like Google to use 
advanced analytics that they have to help us get even earlier 
warning signs than, for instance, the National Use Tobacco 
Survey, which is more retrospective so we can see trends there.
    Senator Durbin. Let me ask you this. By court order, in May 
the FDA is going to have to--is going to receive applications 
for those who want to keep their devices and flavors on the 
market.
    Do you believe that an e-cigarette application should be 
rejected by the FDA unless the company proves with scientific 
and medical evidence that the product actually helps adults 
quit smoking tobacco cigarettes, does not cause youth to start 
smoking and does not harm the user?
    Secretary Azar. So on the first part of your question, 
which is smoking cessation, that would be imposing a drug 
approval criteria in there because, of course, a smoking 
cessation device is an NDA, a new drug approval, that would be 
a different bar than what the Tobacco Control Act has, and I 
believe the standard is that it promotes public health. I 
believe it is something like that in terms of the standard for 
FDA.
    Senator Durbin. Not appropriate for the protection of 
public health is at least one reference.
    Secretary Azar. Right. Right.
    Senator Durbin. But, of course, is not that the marketing 
message of folks in e-cigarettes and vaping to quit tobacco 
cigarettes?
    Secretary Azar. If they use a smoking cessation messaging 
without drug approval for their product, we will enforce 
against them and in fact, we did issue a warning letter against 
a major manufacturer that was putting smoking cessation claims 
or implicit claims connected with their product.

                      UNACCOMPANIED ALIEN CHILDREN

    Senator Durbin. If I could switch to a much different 
topic. Thanks for your kind words on DTC. I want to talk about 
the zero tolerance issue and the fact that I joined with 
Senator Murray and others dealing with what happened to the 
kids who were forcibly separated from their parents at the 
border.
    And there was a study done at our request, but it came back 
and said we cannot even find many of these kids or their 
parents. Can you tell me at this point how many children are 
currently still separated from their parents pursuant to that 
zero tolerance policy or the preceding policy which had the 
same impact?
    Secretary Azar. So I want to make sure, and I will ask if 
we could get you for the record. I want to be sure of this. But 
I believe that we do not have in our care at ORR any children 
that remain as a result of the zero tolerance family--the zero 
tolerance policies.
    So I believe that to be the case. I thought we were down to 
zero of them. But I want to make--we will make sure and get you 
that information for the record.
    Senator Durbin. And so as you sit there you believe that 
every parent whose child was taken into HHS custody has been 
reunited with their child?
    Secretary Azar. They have either been reunited or they have 
not been parents or they are unfit for reunification or they 
have disclaimed their rights to reunification. I want to be 
careful because I know there was one instance where there was 
an individual I think in Guatemala that we were still having 
trouble finding the parent.
    But I believe that was resolved. That is why I want to be 
very careful to get back to you on the record to make sure we--
I have got every bit correct.
    Senator Durbin. My closing point, and I hope we look into 
this. I hope we are sensitive to this. There remain in Mexico a 
program which is now--involves thousands of people and 
children.
    There have been reports from human rights organizations 
about terrible abuse including sexual abuse of children and 
adults who are on the Mexican side of the border waiting for 
some sort of resolution of their status here in the United 
States.
    Do you accept some responsibility to monitor that program 
in terms of its impact on these people?
    Secretary Azar. So I am not involved in the DHS Mexico 
migration policy. That is not--our authority does not go to 
that. Our authority really is just the unaccompanied children 
if they come across by themselves or if a parent leaves a child 
here on that returning to Mexico side of things.
    Senator Durbin. I understand the jurisdictional issue. But 
I just hope, and I know you are a caring person, that you 
understand that when we turn away asylees--people seeking 
asylum and leave them in Mexico, we at least have some role in 
this and should accept some moral responsibility for the 
outcome.
    Thank you, Doctor.
    Senator Blunt. Senator Durbin, if you want to stay for a 
minute we are going to wrap up. But if you have another 
question we could----
    Senator Durbin. I do not. Thank you.
    Senator Blunt. Okay. Senator Murray.

                      UNACCOMPANIED ALIEN CHILDREN

    Senator Murray. Mr. Secretary, I want to follow up on what 
Senator Durbin brought up, because I am really frustrated by 
the department's failure to protect migrant children against 
harmful policies, especially when it comes to sharing 
information with the Department of Homeland Security.
    Over the past couple of months, we have learned from news 
reports the White House hatched a plan to embed ICE agents 
within the Office of Refugee Resettlement and use information 
from unaccompanied children's potential sponsors to target them 
for deportation.
    And then we heard reports that ICE (Immigration and Customs 
Enforcement) is implementing a widespread policy to fingerprint 
unaccompanied children who turn 14 while they are in HHS 
custody without legal representation present.
    And now we are hearing another bombshell that HHS has been 
sharing migrant children's confidential therapy notes with ICE, 
who has then used them to weaponize that information to deny 
asylum claims.
    Now, I am extremely worried about this. In the past, the 
care and protection of children was purposely separated from 
immigration and enforcement, and this is really alarming to me 
that these actions are being taken.
    So just one question and I will follow up with you later. 
But I understand children were told that the conversations with 
their therapists were confidential.
    Is the department now making clear anything children say in 
these sessions will be shared with ICE?
    Secretary Azar. Those notes from therapists or mental 
health counselors talking to children should not be disclosed 
absent the child's consent or the limited--the most limited 
information possible in the event of a threat to themselves or 
others that is disclosed. The sharing----
    Senator Murray. Who decides that?
    Secretary Azar. So that would be the therapist.
    The sharing of that information that occurred we discovered 
this is August of 2019 that there had been a problem since a 
guidance that was issued in 2016 where some of our--where 
therapist notes were being provided over.
    What should happen properly is limited information about 
the child's protection or about the child's threat to others 
should go into a serious incident report in the system. That 
should be the minimal information needed.
    We found that some of our therapists were--grantee 
therapists were cutting and pasting notes, putting them in the 
SIRs or incorrectly the full notes.
    Senator Murray. So are you telling your therapists now that 
they cannot share information with ICE or, conversely, are you 
telling the children that anything they say in those 
confidential therapies will be shared?
    Secretary Azar. No. So as of--as of August 2019, we 
clarified our instructions that these notes should not be 
shared with anybody absent a child's consent and that any--
well, and any or, of course, but that is not----
    Senator Murray. How do you ask a child, is it okay if I 
share this with somebody you had never met? Yes.
    Secretary Azar. No, they do not. That would not--I would 
not hang up on that. They are not being shared unless a child 
were to consent. The information in these serious incident 
report would be if they threatened themselves or others.
    Senator Murray. How do you ask a child if----
    Secretary Azar. That would be put in the SIR and that would 
go over--that is a legal requirement.
    Senator Murray. Okay. I will just tell you, saying to a 
child that this may be shared means nothing to them.
    Secretary Azar. No, we are not saying it may be shared. We 
are saying it is the standard mental health professional 
requirements that if you threaten yourself or others that fact 
is discloseable and that would be disclosed.
    Senator Murray. Well, I am deeply----
    Secretary Azar. But we stopped this. This was in error that 
those notes were going over and that was stopped in August of 
2019, long before it became a media story.
    Senator Murray. Okay. I hear that. But you also said that 
if the child consents, then they will be shared. How can a 
child consent? I would ask my attorney over here.
    Senator Durbin. It has been a long time since I practiced 
law. But if you are a child and do not have the capacity, how 
are you going to make this consent and what does it mean to a 
child?
    Secretary Azar. Well, it would be working--our children 
have legal counsel and so they would--that we pay for and so it 
would be working with them on that.
    I will get back to you about that if----
    Senator Durbin. Would you please? I certainly think you may 
have----
    Secretary Azar. Certainly. But the most important issue is 
that this was a mistake. It should not have been happening as 
it was identified. It was stopped. We do respect the privacy of 
these mental health conversations.
    As Chairman Blunt knows, we--I am very passionate about 
access to mental healthcare. We want to make sure this happens 
and that kids are protected, and it was a mistake. We fixed it 
and on a going forward basis it should not be happening.
    Senator Murray. Okay. Can you get back to Senator Durbin 
and I as quickly as possible what the policy is on how you ask 
a child and when they are shared?
    Secretary Azar. You bet.
    Senator Blunt. Well, Secretary, thank you for staying with 
us. Thank you for the time you spent today in your leadership 
at the agency.

                     ADDITIONAL COMMITTEE QUESTIONS

    The record will stay open for 1 week for additional 
questions. I would like to be included on any response on that 
last question. I think that probably is something that when you 
look back at your answer there is a--we need some clarification 
on that.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]
                 Questions Submitted to Hon. Alex Azar
                Questions Submitted by Senator Roy Blunt
                             ebola response
    Question. When this Subcommittee developed the fiscal year 2020 
bill, with your Department's technical assistance, we added funding and 
continued authority to the Infectious Disease Fund to be used for the 
ongoing Ebola response in the Democratic Republic of the Congo. How 
will the replenishment of the Infectious Disease Fund allow HHS to 
respond to both the coronavirus and Ebola outbreak simultaneously? How 
much does HHS expect to allocate to Ebola response in fiscal year 2020?
    Answer. The Infectious Diseases Rapid Response Reserve Fund 
(IDRRRF) has been a critical resource for the initial response to the 
COVID-19 pandemic. For the COVID-19 response, this fund was utilized 
for immediate planning and response needs, enhanced laboratory 
capacity, communication and education efforts, medical screening, and 
surge capacity for ports of entry. As CDC is responding to COVID-19, we 
have also continued our response for the Ebola Outbreak that began in 
August 2018. In fiscal year 2020, $30 million was transferred from 
IDRRRF for Ebola Response, of which $7.68 million has been obligated. 
Infectious disease emergencies are unpredictable and can emerge at any 
time. Rapidly evolving outbreaks require flexibility to respond with 
the latest information. The IDRRRF will allow CDC to respond 
immediately and effectively in the future.
                                opioids
    Question. The CDC recently announced that Americans' life 
expectancy rose for the first time since 2014. This is certainly 
encouraging news, particularly because it speaks to the fact that the 
number of opioid deaths has declined for the first time in a long time. 
What can you say about the latest trends in opioid overdoses and what 
we need to do to keep up this positive momentum?
    Answer. While the problem persists, overall total opioid 
prescriptions and overdoses are down from the preceding year, which 
demonstrates positive developments in this epidemic and underscores the 
need for sustained effort. More providers are trained to diagnose and 
treat substance use disorder since the opioid epidemic began. 
Prevention of overdose deaths through naloxone distribution, treatment 
capacity expansion for medication assisted treatment for opioid 
treatment programs and office based treatment, and provider education 
efforts through SAMHSA's Provider Clinical Support System, among other 
Federal efforts, have all contributed to the reversing trend. 
Individuals who enter substance use disorder treatment often engage in 
other beneficial behaviors such as obtaining primary healthcare, 
decreased transmission of infectious diseases, decreased criminal 
justice involvement, and higher rates of employment. Quite simply, if 
substance use frequency has decreased, more individual resources can be 
used for healthier living like better nutrition and compliance with 
healthcare. Facilities and providers for treatment of opioid use 
disorder are often the catalyst for some of these other healthy 
behaviors. While there are several initiatives that should be pursued, 
continued commitment to the initiatives of provider education, 
treatment expansion, as well as both primary and overdose prevention is 
essential to maintain and build upon these successes. In addition, HHS 
launched a comprehensive 5-Point Strategy to empower local communities 
on the frontlines. The opioid epidemic is one of the Department's top 
priorities; through the 5-Point Strategy and HHS's Agency Priority Goal 
of Reducing Opioid Morbidity and Mortality, the Department continues to 
focus on most effective efforts for addressing opioid use disorder.
    Question. Mr. Secretary, the $1.5 billion State Opioid Response 
grant is provided directly to States through a flexible grant so States 
can use funds as they see fit. Unfortunately, we continue to hear that 
States are not spending those funds in a timely manner. Does HHS know 
why this is the case? What can be done to increase the spending rates?
    Answer. The State Opioid Response (SOR) grant was awarded to each 
State and territory to combat the current opioid epidemic. Funds have 
been used to provide evidence-based prevention, treatment and recovery 
support services. However, some States are having trouble with spending 
down their funds in a timely manner due to multiple barriers and 
challenges faced in their respective jurisdictions. Here are some 
examples of these barriers:
  --Contract Procurement: Grantees have identified contract procurement 
        as one of the biggest challenges that hinder their rapid 
        spending of the SOR funds. The solicitation, contracting and 
        purchasing process can be lengthy, which results in most of 
        their SOR activities starting several months into the grant 
        year.
  --Workforce Development: Grantees have also indicated that they are 
        having difficulty identifying, recruiting, and retaining 
        qualified staff for treatment and recovery programs due to the 
        lack of workforce in the field.
    Many of these issues are at the local level. SAMHSA works regularly 
with grantees to provide increased training and education of providers 
to ensure that the workforce development needs are being addressed to 
the greatest extent possible.
                   ending the hiv epidemic initiative
    Question. The fiscal year 2021 budget requests $716 million for the 
``Ending HIV'' initiative, more than double the first year of funding. 
The Committee is aware that this is a multi-year initiative that will 
continue to require resources in future years. Can we expect the 
request to more than double next year as well? What factors will drive 
future funding request?
    Answer. Future funding requests will be developed through the 
annual budget process, which takes into consideration the current 
budget environment and other Departmental priorities. Out-year costs 
for the Ending the HIV Epidemic (EHE) Initiative depend on several 
factors, including rates of infection, finding and linking those with 
HIV to care and treatment, and our ability to prevent new HIV 
infections by using evidence-based comprehensive prevention tools such 
as pre- exposure prophylaxis (PrEP). Future estimates will be driven by 
the ability to prevent new HIV transmissions, which will result in 
potential cost savings in later years of the EHE Initiative. Based on 
economic modeling, the primary drivers of costs associated with 
successfully meeting the EHE goals--a 75 percent reduction in HIV 
incidence in 5 years and a 90 percent reduction within 10 years--
include:
    Diagnosis/Prevention: Critical to the success of the Initiative 
will be our ability to test and diagnose people with HIV as early as 
possible and link them to care. Of the estimated 1.1 million people 
with HIV in the U.S., an estimated 1 in 7 do not know they are HIV-
positive. For those who receive a negative test result, but who are at 
increased risk for HIV, the key to reaching the goals of the initiative 
will be to ensure they have access to comprehensive HIV prevention 
including PrEP medications and services. We estimate of the 
approximately 1.1 million people who have an indication for PrEP 
medications, fewer than 20 percent are currently being prescribed PrEP. 
Costs associated with this pillar include testing, referrals, and 
systems necessary to reach the number of individuals who are estimated 
to have indications for PrEP, but for whom PrEP is not currently 
prescribed.
    Treatment: Success will depend on our ability to treat people with 
HIV rapidly and effectively so that they achieve and sustain viral 
suppression. Scientific evidence shows that individuals who are virally 
suppressed cannot transmit the virus to others, also known as 
Undetectable= Untransmittable (U=U). Costs associated with this 
activity include the costs of antiretroviral therapies and wrap around 
services to ensure individuals stay in care and maintain viral 
suppression.
                          alzheimer's research
    Question. Over the past 5 years, the Labor/HHS Subcommittee has 
prioritized the investment in Alzheimer's research. One of the main 
reasons why is because Alzheimer's is currently the most expensive 
disease in the U.S., and by 2050, the cost to treat an individual with 
Alzheimer's is expected to be $1.1 trillion. But, even without a cure, 
the effect of a research breakthrough that delays onset by 5 years 
would reduce the number suffering from the disease by 42 percent and 
cutting costs by one-third. When I spoke to the National Institute on 
Aging's Director most recently, Dr. Richard Hodes, he said that we are 
at least several years away from a preventative treatment. Mr. 
Secretary, why did you cut funding to Alzheimer's research? Even if you 
felt like you had to cut NIH funding, why would you not safeguard high-
priority research in your budget request?
    Answer. 5.8 million Americans are currently estimated to have 
Alzheimer's disease (AD), and many thousands more have a related form 
of dementia (ADRD). The physical and emotional toll these diseases 
exact upon family, caregivers, and friends can be significant. 
Scientists agree that the number of affected individuals could increase 
significantly if current population trends continue--unless an 
effective treatment or preventive intervention can be identified.
    We have now passed the halfway point between the establishment of 
the National Plan to Address Alzheimer's Disease and the target date of 
effectively preventing and treating AD/ADRD by 2025. We have made 
significant progress towards this goal, and we are enthusiastic about 
the new scientific directions that we are now able to take as a result 
of recent discoveries.
    Our drug discovery efforts have expanded to include both 
``traditional'' (e.g., amyloid and tau proteins) and ``non-
traditional'' AD/ADRD targets, including inflammation, neuroprotection, 
cell metabolism, viruses, pathogens, growth factors, oxidative stress 
and vascular targets. Investigators with the Accelerating Medicines 
Partnership-AD have identified over 500 novel candidate drug targets 
for AD/ADRD, and this data is shared openly for researchers to begin 
target validation and preclinical testing. Therapeutic strategies being 
pursued through the NIA-supported Alzheimer's Drug Development Program 
and other initiatives include small molecule, immune, regenerative, and 
gene therapies.
    The Institute currently supports about 230 active clinical trials, 
including early- and late-stage drug trials; studies of potential 
treatments for the often troubling neuropsychiatric symptoms of 
dementia, such as agitation, apathy, and psychosis; and trials of care 
and caregiver interventions. More than 100 of these trials are testing 
non-pharmacological interventions for both dementia patients and their 
caregivers, including (but not limited to) diet, exercise, and 
cognitive training, and are backed by improved data from cohort studies 
that span the life course and suggest--but don't definitively prove--
the power of lifestyle choices to support cognitive health. We 
anticipate that a number of our large, late-stage (phase II/III) trials 
will be complete before 2025--some by 2021/2022.
    Highly promising results recently came from the SPRINT-MIND study, 
which compared the effects of intensive blood pressure control--i.e., 
targeting a systolic blood pressure of less than 120 mmHg--with 
standard treatment toward a target of less than 140 mmHg on cognition 
and new cases of dementia among 9300 adults ages 50 and older at high 
risk of cardiovascular disease. The investigators found that intensive 
lowering of blood pressure significantly reduced mild cognitive 
impairment (MCI), a well-established risk factor and often a precursor 
to dementia. This is the first randomized clinical trial demonstrating 
that an intervention significantly reduces the occurrence of MCI. 
SPRINT-MIND was co-sponsored by NIA, the National Institute of 
Neurological Disorders and Stroke, the National Institute of Diabetes 
and Digestive and Kidney Diseases, and the National Heart, Lung, and 
Blood Institute.
    Finally, NIA recently established the AD/ADRD Health Care Systems 
Research Collaboratory, which promotes development of pragmatic trials 
and disseminates best practices and guidelines with the goal of 
improving care for persons with dementia and their caregivers through 
health and long-term care systems.
                 2020 physician fee schedule final rule
    Question. Under the 2020 Physician Fee Schedule Final Rule, the 
agency finalized a policy regarding reimbursement regarding billing E/M 
by providers. Some physicians, due to the nature of their specialty, 
will face a Medicare reimbursement cut as a result. Was the impact of 
this policy change on seniors' access to specialty physician services, 
particularly in rural and underserved areas, taken into account when 
creating this change?
    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.
    CMS included a table that shows the estimated specialty level 
impacts of these changes, exclusive of any other changes finalized for 
CY 2020. Those specialties that see the greatest decreases are those 
that do not generally bill office/outpatient E/M visits. These 
estimates can provide insight into the magnitude of potential changes, 
but do not take into account other changes to payment rates finalized 
for CY 2020. Any potential coding changes and recommendations in 
overall valuation for new and existing codes between the CY 2020 and 
the CY 2021 final rules could impact the actual change in the overall 
valuation of office/outpatient visits relative to the rest of the PFS.
                                 ______
                                 
             Question Submitted by Senator Lamar Alexander
                tennessee medicaid block grant proposal
    Question. On November 20, Tennessee submitted its final Medicaid 
block grant proposal to the Center for Medicare and Medicaid Services 
(CMS). Tennessee already administers the Medicaid program, known as 
TennCare, under an 1115 waiver. This new proposal will give Tennessee 
more control over how to operate TennCare and allow the State to 
improve health outcomes for Tennesseans. If approved, the proposal will 
also save billions of dollars in healthcare spending. Tennessee has 
made clear that the State does not intend to reduce the benefits that 
current TennCare members receive, and that no changes to benefits for 
children under age 21 are contemplated as part of the block grant 
proposal. If the block grant is approved, Tennessee has already 
identified specific priorities to improve health outcomes. These 
priorities include investments in prenatal and postpartum health; 
covering additional populations through Medicaid; addressing other 
State-specific health crises, including the opioid epidemic and 
healthcare access in rural and underserved areas. CMS recently 
announced new flexibilities for States to better design and administer 
their Medicaid program. Many of these flexibilities are included in 
Tennessee's proposal currently under review by CMS.
    What is the review process for Tennessee's Medicaid block grant 
proposal and when can Tennessee expect a response?
    Answer. As you may be aware, section 1115 of the Social Security 
Act (Act) gives the Secretary of Health and Human Services authority to 
approve experimental, pilot, or demonstration projects that are found 
by the Secretary to be likely to assist in promoting the objectives of 
the Medicaid program. The purpose of these demonstrations, which give 
States additional flexibility to design and improve their programs, is 
to demonstrate and evaluate State-specific policy approaches to better 
serve Medicaid populations.
    As with all demonstrations authorized under section 1115 of the 
(Act), CMS plays an important role in reviewing and approving any 
project designs. Specifically, CMS performs a case-by-case review of 
each proposal to determine whether its stated objectives are aligned 
with those of Medicaid. CMS also considers whether proposed waiver 
expenditures are appropriate and consistent with Federal policies, 
including the degree to which they supplant State-only costs for 
existing programs or services and can and should be supported through 
other Federal and non-Federal funding sources. You asked specifically 
about Tennessee's recent application. We are working through 
Tennessee's application, which was submitted after CMS began 
development of the Healthy Adult Opportunity guidance, announced 
January 30, 2020. We are committed to working with Tennessee and any 
State that would like to put forward an innovative idea for improving 
their Medicaid program.
                                 ______
                                 
          Questions Submitted by Senator Shelley Moore Capito
                          alzheimer's disease
    Question. Can you share how the Department is beginning to 
implement the BOLD Infrastructure for Alzheimer's Act across the 
country?
    Answer. CDC has published two funding opportunities in fiscal year 
2020, the BOLD Public Health Programs to Address Alzheimer's Disease 
and Related Dementias (CDC-RFA-DP20-2004) Notice of Funding Opportunity 
and the BOLD Public Health Centers of Excellence to Address Alzheimer's 
Disease and Related Dementias (CDC-RFA-DP20-2005) Notice of Funding 
Opportunity, to carry out actions from the Building Our Largest 
Dementia (BOLD) Infrastructure for Alzheimer's Act PL 115-406. 
Applications are due on May 26, 2020.
    Question. What steps is the Department taking to screen, detect, 
and diagnose Alzheimer's and related dementias in their earliest 
stages? Are there existing opportunities, such as the Welcome to 
Medicare initial exam and Medicare annual wellness which could be 
utilized to help achieve this?
    Answer. Both the Welcome to Medicare and the Medicare Annual 
Wellness visit can be utilized to screen, detect, and diagnose 
Alzheimer's disease and related dementias. In addition, CDC has created 
tools and training to fill knowledge gaps. These include the Healthy 
Brain Initiative State and Local Public Health Partnerships to Address 
Dementia: The 2018-2023 Road Map to assist State and local public 
health in creating dementia-friendly communities. The Road Map includes 
25 actionable steps States can take to ensure their communities are 
prepared to meet the challenges ahead. These steps include screening, 
detecting, and diagnosing Alzheimer's disease and related dementia.
    In addition, to address educational gaps in healthcare provider 
training, CDC worked in partnership with the Alzheimer's Association 
and the American College of Preventive Medicine and developed the 
online brain health curriculum for healthcare providers and students of 
public health. A Public Health Approach to Alzheimer's and Other 
Dementias is an introductory curriculum that is intended to increase 
awareness of the impact of Alzheimer's disease and other dementias as 
well as the role of public health.
                       childhood cancer star act
    Question. Can you provide an update on the work being done by the 
Department on the implementation of the Childhood Cancer STAR Act of 
2018?
    Funding was specifically included in the Childhood Cancer STAR Act 
to be awarded to State cancer registries to enhance and expand 
infrastructure to track cancer in children, adolescents, and young 
adults. Is progress being made in this area?
    Answer. Progress is being made on the implementation of the 
Childhood Cancer STAR Act. Activities being carried out by CDC include:
  --Awarded a contract on September 29, 2019 to develop a software tool 
        that will aid pediatric cancer reporting facilities with 
        rapidly submitting cancer incidence to Central Cancer 
        Registries (CCRs).
  --Convened a roundtable meeting on Feb. 12th-13th to provide an 
        overview of the STAR project, clarify expectations of the 
        participating pilot States and gather information/input from 
        States regarding features that would be optimal for the STAR 
        tool that is being developed. This included 15 CCRs and two 
        hospital facilities from the following States: LA, OH, GA, CA, 
        NE, NE, MN, TX, RI, NH, KY, FL, and UT.
  --Conducting individual calls with 14 CCRs to better understand their 
        staff, data collection methods, State laws, software, 
        challenges, successes, and interest in the project.
  --Contacting experts from pediatric cancer organizations, pathology 
        labs, children's hospitals, and other subject matter experts to 
        gather information relative to use and dissemination of data.
  --Establishing a set of criteria to select the CCR who will pilot the 
        new software tool in December.
  --Determining the histology and data elements that will be used for 
        data collection.
  --Working closely with the contractor to ensure scalability.
    The following text summarizes progress in implementing sections of 
the Childhood Cancer STAR Act directed toward the National Institutes 
of Health (NIH), including those directed specifically to the National 
Cancer Institute (NCI).
    Section 101: Children's cancer biorepositories and biospecimen 
research.
    NCI convened a meeting in May 2019 of more than 60 extramural 
researchers and advocates, along with NCI scientific staff, to discuss 
challenges and opportunities to enhance biobanking for childhood 
cancers. Informed by this discussion, in fiscal year 2019 NCI provided 
a grant supplement award to Nationwide Children's Hospital to support 
immediate enhancements to the Children's Oncology Group Biorepository. 
NCI scientific leadership has identified additional opportunities to 
enhance and expand childhood cancer biospecimen collection and 
biobanking resources in fiscal year 2020 and will soon be moving 
forward to solicit applications.
    Section 111: Inclusion of at least one pediatric oncologist on the 
National Cancer Advisory Board. There are currently two pediatric 
oncologists appointed to the National Cancer Advisory Board (NCAB). Dr. 
Peter Adamson of the Children's Hospital of Philadelphia was appointed 
to NCAB in 2015 and his term concludes in 2020. In October 2019, 
President Trump announced the appointment of Dr. Andrea Hayes-Jordan, 
Surgeon-in-Chief at the University of North Carolina Children's 
Hospital. Dr. Hayes-Jordan's appointment is pending final approval, and 
her NCAB term is expected to conclude in 2024.
    Section 112: Sense of Congress regarding pediatric expertise at the 
National Cancer Institute. In addition to pediatric oncology expertise 
on NCAB, other NCI advisory boards, groups, and committees continue to 
include pediatric oncologists, scientists with pediatric expertise, and 
patient advocates. This includes more than 40 subject matter experts 
with pediatric expertise across three relevant NCI National Clinical 
Trials Network Steering Committees, with a patient advocate serving on 
each committee.
    Section 121: Reporting on childhood cancer research projects. NCI 
and NIH reporting on childhood cancer research projects will continue 
to include the annual NIH Pediatric Research Initiative Report to 
Congress, as well as the NIH Triennial Report. After the close of each 
fiscal year, NIH also makes estimates of funding for various Research, 
Condition, and Disease Categories (RCDC) available on its website, 
including a ``Pediatric Cancer'' category, which links through to a 
list of hundreds of research projects supported by several NIH 
Institutes and Centers. NCI also reports on activities across its 
childhood and adolescent and young adult (AYA) cancer research 
portfolio on its website through several pages focused on childhood and 
AYA cancer research and resources for patients and families.
    Section 202: Grants to improve care for pediatric cancer survivors. 
NCI continues to conduct and support critical ongoing childhood and AYA 
survivorship research efforts, including NCI's long-standing investment 
in the Childhood Cancer Survivor Study. In fiscal year 2019 NCI also 
supported several new childhood and AYA survivorship research projects, 
including three new projects funded through a request for applications 
(RFA) developed to align with Section 202 of the STAR Act. The second 
receipt date for this RFA was in January 2020. Peer review is currently 
underway for this second round of applications, and NCI expects to make 
several awards in fiscal year 2020. Additionally, in December 2019, 
NCI's Board of Scientific Advisors approved a new RFA aligned with 
Section 202 of the STAR Act. This RFA is expected to post to the NIH 
Guide for Grants and Contracts later this year, with application 
receipt dates scheduled for 2021 and 2022.
         samsha interagency task force on trauma-informed care
    Question. The ``SUPPORT for Patients and Communities Act'' created 
the Interagency Task Force on Trauma-Informed Care. I understand that 
the Task Force has met a number of times over the past year and is 
moving forward with its operating plan which should be released in 
April or May. Can you explain the role stakeholders are playing in the 
creation of this operating plan? Are other opportunities for public 
engagement being planned in regards to the Task Force?
    Answer. Stakeholders will play a major role in the development of 
the National Strategy and in the development of the website. Through a 
human centered design approach, SAMHSA's Center for Mental Health 
Services (CMHS), with assistance from the United States Digital 
Services, will engage the stakeholders specified in the legislation.
        non-opioid alternatives in surgery/post-surgery settings
    Question. It has been brought to my attention that current Medicare 
payment systems may incentivize the use of opioids over proven non-
opioid alternatives--such as continuous peripheral nerve blocks and 
other treatments. Are you considering any further changes to Medicare's 
payment systems in order to incentivize doctors and healthcare 
providers to use alternative methods over opioids?
    Answer. In the calendar year (CY) 2019 final rule for the Medicare 
outpatient prospective payment system (OPPS) and ambulatory surgical 
center (ASC) payment system, we finalized a policy to unpackage and pay 
separately at average sales price (ASP) +6 percent for the cost of non-
opioid pain management drugs that function as surgical supplies when 
they are furnished in the ASC setting for CY 2019 due to an observed 
decrease in utilization of these drugs in the ASC setting.
    As required under section 6082 of the SUPPORT Act, for purposes of 
the CY 2020 OPPS/ASC proposed rule, CMS conducted an evaluation of its 
payment policies for opioids and evidence-based non-opioid alternatives 
under these systems. The goal of this analysis was to determine whether 
our packaging policies reduced the use of non-opioid alternatives and 
incentivized the use of opioids. We believed that if CMS packaging 
policies discouraged the use of these non-opioid alternatives or 
impeded access to these products, our analysis would show a decline in 
utilization of non-opioid alternatives over time.
    In our evaluation, we looked at several devices used in covered 
medical procedures to determine if the current packaging policy 
represented a barrier to access. For each product, the most recently 
available Medicare claims data as well as medical literature relating 
to use of these products being used as an alternative to opioids was 
examined. All of the alternatives examined showed consistent or 
increasing utilization in recent years, with no products showing 
decreases in utilization in the OPPS setting, suggesting that current 
payment policy does not present a barrier to access of these products.
    Drugs that function as surgical supplies were examined over a 6-
year time period (CYs 2013 through 2018). During our evaluation, we did 
not observe significant declines in the total number of units used in 
the hospital outpatient department for a majority of the drugs included 
in our analysis. In fact, under the OPPS, we observed the opposite 
effect for several drugs that function as surgical supplies. Similar to 
the findings associated with devices above, this trend indicated 
appropriate packaged payments that adequately reflect the cost of the 
drug and are not prohibiting beneficiary access.
    The results of this review and evaluation of medical literature and 
claims data did not support evidence to indicate that our packaging 
policies had the unintended consequence of discouraging the use of non-
opioid treatments for postsurgical pain management in the OPPS setting, 
including drugs that function as a surgical supply, nerve blocks, or 
neuromodulation products.
    To broaden our analysis, the CY 2020 OPPS/ASC proposed rule also 
sought public comment on other non-opioid treatments for acute pain 
that might be affected by OPPS and ASC packaging policies and warrant 
separate payment. However, the public comments and data that CMS 
received regarding specific products did not provide sufficient 
evidence-based support that the current packaged payment policies for 
these non-opioid alternatives presented a barrier to access to care and 
warranted revised, separate payment to reduce incentives. We provide 
further analysis of our review of these specific products in the CY 
2020 OPPS/ASC final rule (CMS-1717-FC) released on November 1, 2019.
    We will continue to analyze the issue of access to non-opioid 
alternatives in the OPPS and the ASC settings for any subsequent 
reviews we conduct under Section 6082 of the SUPPORT Act. We are 
continuing to examine whether there are other non-opioid pain 
management alternatives for which our payment policy should be revised 
to allow separate payment under the OPPS.
                        fast act implementation
    Question. The FAST Act, which was enacted in December 2015, 
mandated that HHS issue technical guidelines for the adoption of hair 
testing as a federally-accepted alternative drug testing method within 
1 year of the bills enactment. Unfortunately, that deadline, which was 
December 4, 2016, is now well over 3 years past due. Will you commit 
HHS to providing DOT guidelines that will provide trucking companies an 
extremely effective safety tool, as mandated by Congress in the FAST 
Act, to ensure that their drivers are not using prohibited substances?
    Answer. The proposal for Mandatory Guidelines for Federal Workplace 
Drug Testing Programs-Hair is currently under Executive Branch and 
interagency review and coordination. When this process is complete, we 
anticipate publishing the proposed Guidelines in a Federal Register 
Notice.
                              biosimilars
    Question. The President's budget states support for changes to 
bring lower-cost generic and biosimilar drugs to patients, as a way to 
lower out-of-pocket costs for patients.Are there specific actions, 
regulatory or legislative, that you propose to improve uptake of 
biosimilars and ensure patients have access to these lower-cost 
treatment options?
    Answer. FDA will continue to play a critical role in facilitating 
increased access to biosimilars. FDA continues to implement the 
Agency's Biosimilars Action Plan (BAP), first announced in July 2018, 
to promote competition and affordability across the market for 
biologics and biosimilar products. The BAP applies many of the lessons 
learned from our experience with generic drugs to accelerate biosimilar 
competition with four key strategies including: (1) improving the 
efficiency of the product development and review process; (2) 
maximizing scientific and regulatory clarity for the product 
development community; (3) developing effective communications to 
improve understanding among interested parties; and (4) supporting 
market competition by reducing attempts to unfairly delay market 
competition. The Agency is also supporting uptake by educating 
clinicians, payors, and patients about biosimilar products and the 
rigorous evaluation they must go through. FDA is modernizing regulatory 
policies to accommodate new scientific tools that can better enable 
comparison between biosimilars and reference products that may reduce 
the need for clinical studies.
    Relatedly, FDA has also taken steps to ensure a smooth regulatory 
transition aimed at increasing patient access to insulin products used 
daily by millions of Americans to maintain stable blood glucose levels, 
as well as certain other biological products set to transition 
regulatory pathways in March. On March 23, 2020, each application for a 
biological product approved under the Federal Food, Drug, and Cosmetic 
Act (FD&C Act), including applications for insulins and other 
biological products, was deemed to be a license for the product under 
the Public Health Service (PHS) Act. For the first time, thi enabled 
submission of applications for products that are proposed as biosimilar 
to, or interchangeable with, the transitioned products. As such, the 
transition of insulin products from approved drug applications to 
deemed biological product licenses will open up those products to 
potential biosimilar and interchangeable competition.
    The availability of approved biosimilar and interchangeable insulin 
products is expected to increase patient access, adding more choices 
and potentially reducing costs of insulin products.
                                 ______
                                 
            Questions Submitted by Senator Cindy Hyde-Smith
    Question. Secretary Azar, I was encouraged by the Administration's 
2019 Executive Order on Modernizing Influenza Vaccines in the United 
States to Promote National Security and Public Health. Many of the 
vaccines we use today are produced overseas, creating a national 
security vulnerability during a global influenza pandemic. The White 
House Council of Economic Advisors also issued a report, which detailed 
the significant health and economic impacts of a potential influenza 
pandemic as well as the advantages that new vaccine manufacturing 
technologies have by developing vaccines faster and better matching the 
influenza virus strains circulating in a given year. As we are 
considering fiscal year 2021 appropriations, please provide the 
Committee a copy of the National Influenza Vaccine Task Force report 
required in the Executive Order within 30 days.
    Answer. The Task Force report is due June 2020, and is in the final 
stages of drafting at this time. We will provide the Committee with a 
copy as soon as the report is finalized.
    Question. Secretary Azar, I was disappointed to see the 
Administration's 2021 budget request propose a $200 million cut to 
BARDA's Special Reserve Fund (SRF). As you know, the SRF funds 
procurement of medical countermeasures (MCMs) under FDA Emergency Use 
Authorization. Over the last 15 years, this successful program has 
stockpiled millions of doses of vaccines and treatments to prepare the 
United States against a chemical, biological, radiological, or nuclear 
(CBRN) event. It is a critical national security asset and has broad 
bipartisan support in this committee and the entire Congress. This 
stunning cut you've proposed--which would amount to 27 percent of the 
SRF budget--flies in the face of this year's professional budget 
estimate prepared by the experts in the Public Health Emergency Medical 
Countermeasure Enterprise (PHEMCE). It also defies logic--why would we 
sacrifice preparedness against the most serious threats we face as a 
Nation?
    Do you understand the national security consequences of gutting the 
SRF?
    Answer. HHS identified an immediate need in fiscal year 2020 to 
promote the development of an Ebola medical countermeasures product. 
Congress provided an additional $535 million via supplemental 
appropriation in fiscal year 2020 directly for this purpose. The 
decision to reduce the SRF in the fiscal year 2021 budget request was 
based on the forward-funding of this Ebola candidate. At the diminished 
level, there are no long-term, significant impacts to the SRF of 
Project BioShield investments.
    In fiscal year 2020, Congress appropriated $535 million in 
emergency supplemental funding to the PHSSEF to support procurement of 
Ebola vaccines, therapeutics and diagnostics. BARDA will use this 
funding to move forward with procurement of at least one vaccine, one 
therapeutic and potentially two diagnostics for the Ebola Zaire strain. 
BARDA will obligate an additional $200 million provided through the 
fiscal year 2020 PBS appropriations to support additional late-stage 
development activities to support licensure of the various medical 
countermeasures. These activities could include phase IV post-marketing 
requirements or commitments.
    Question. Have you considered the long-term impact this cut will 
have on the Department's partners in the private sector who are working 
on MCM research and development?
    Answer. HHS identified an immediate need in fiscal year 2020 to 
promote the development of an Ebola medical countermeasures product. 
Congress provided an additional $535 million via supplemental 
appropriation in fiscal year 2020 directly for this purpose. The 
decision to reduce the SRF in the fiscal year 2021 budget request was 
based on the forward-funding of this Ebola candidate. At the diminished 
level, there are no long-term, significant impacts to the SRF of 
Project BioShield investments.
    In fiscal year 2020, Congress appropriated $535 million in 
emergency supplemental funding to the PHSSEF to support procurement of 
Ebola vaccines, therapeutics and diagnostics. BARDA will use this 
funding to move forward with procurement of at least one vaccine, one 
therapeutic and potentially two diagnostics for the Ebola Zaire strain. 
BARDA will obligate an additional $200 million provided through the 
fiscal year 2020 PBS appropriations to support additional late-stage 
development activities to support licensure of the various medical 
countermeasures. These activities could include phase IV post-marketing 
requirements or commitments.
    Question. Will you commit to reevaluating the Administration's 
proposed 2021 funding level for the SRF?
    Answer. Based on what was described in the response above, there is 
no benefit or need to reevaluate the fiscal year 2021 proposal at this 
time.
    Question. Secretary Azar, while this novel coronavirus has become 
an unexpected global epidemic, the emergence of deadly new viruses are 
one of the most predictable public health threats we face. As the 
saying goes, it's not a matter of if but when the next outbreak will 
occur. I believe Congress should provide additional emergency funding 
to battle the coronavirus outbreak. And I worry that if we don't, HHS 
and other agencies will be forced to pull funding from other accounts 
in the biodefense and pandemic preparedness space. The long term 
solution to this problem is a sustained response fund at HHS.
    Can you share with us the consequences of not properly funding HHS' 
response to the coronavirus outbreak?
    Answer. Prior to the enactment of the Coronavirus Preparedness and 
Response Supplemental Appropriations Act, 2020, HHS was considering 
reallocating program funds to support a response. On February 2, 2020, 
HHS notified Congress of its intent to transfer funds to support COVID-
19 activities. The notification included a transfer of up to $75 
million to support CDC, up to $52 million to support the Public Health 
and Social Services Emergency Fund, and up to $8.5 million to other 
parts of the HHS Office of the Secretary. After the enactment of the 
Coronavirus Preparedness and Response Supplemental Appropriations Act, 
2020, the transferred funding was returned to the original appropriated 
accounts.
    Question. What other accounts at HHS--such as SNS and BARDA--would 
suffer as a result of having to divert resources to the coronavirus 
response?
    Answer. The Strategic National Stockpile (SNS) has met and 
continues to meet requests for personal protective equipment (PPE) from 
States. While the SNS has significant materiel on hand, HHS will also 
use supplemental funding for replenishment.
    Question. How important is it to have a dedicated response fund at 
HHS/ASPR moving forward?
    Answer. The Public Health Emergency (PHE) Fund is authorized to 
fund rapid response to immediate needs resulting from a PHE, or to 
rapidly respond to a potential PHE when the Secretary determines that 
there is a significant potential for a PHE; however, this fund has not 
received an appropriation in over twenty years.
    Question. Secretary Azar, I believe the Strategic National 
Stockpile (SNS) will play a critical role in the U.S. response to the 
coronavirus outbreak. In the short-term, the SNS needs to distribute 
critical medical supplies to hospitals and other first responders. Over 
the long- term, the SNS will play a role in the purchase a distribution 
of medical countermeasures including vaccines and treatments.
    Can you speak the role the SNS will play in HHS' response to the 
coronavirus outbreak?
    Answer. The Strategic National Stockpile (SNS) holds millions of 
face masks, N95 respirators, gloves and surgical gowns that are being 
deployed as State and local supplies are diminished due to the current 
the COVID-19 response and commercial supplies are exhausted. The SNS 
has met and continues to meet requests for PPE from States. The SNS is 
filling these orders as quickly as possible to ensure the healthcare 
system is prepared and able to respond.
    Recently, the SNS issued a request for proposals for 500 million 
N95 respirators plus additional personal protective equipment to 
protect frontline healthcare workers and first responders, with the 
goal of maintaining the resiliency of the American healthcare system. 
The intent behind the request for proposals is to surge domestic 
personal protective equipment manufacturing capabilities.
    Question. Does the SNS need additional resources to carry out this 
role?
    Answer. The funding provided by the supplemental will aid in the 
replenishment of supplies within the SNS.
    Question. If so, what are the consequences to not providing these 
additional resources to the SNS?
    Answer. No response needed as supplemental funding was provided.
    Question. Secretary Azar, over the past few weeks, I have become 
concerned with China's response to the coronavirus outbreak. Among 
other issues, I worry that China has taken an aggressive stance 
regarding the development of novel vaccines and therapeutics to combat 
the outbreak. China has stated publicly they intend to aggressively 
pursue the intellectual property and manufacturing capacity of 
coronavirus treatments.
    How do we ensure the availability to new coronavirus treatments in 
the United States given this aggressive posture from China?
    Answer. FDA is committed to working with medical product developers 
and other researchers and manufacturers, including those very early in 
the development process, to help expedite the development and 
availability for U.S. patients of medical products such as vaccines, 
antibodies, and drugs to prevent and treat COVID-19. As part of these 
discussions, FDA is willing to consider different strategies, as 
appropriate, to help facilitate and expedite development of novel 
vaccines and therapeutics. This includes not only pre-clinical and 
clinical trial design strategies, but also working closely with 
companies on manufacturing issues to allow them to scale up as 
necessary. With respect to vaccines, the Agency encourages developers, 
to the extent they are not already doing so, to leverage previous 
development work, including platform technologies from vaccines already 
in advanced development, in the development of COVID-19 vaccines.
    We are leveraging all domestic resources to aid the development of 
safe and effective vaccines and therapeutics. BARDA has made five 
awards thus far; two vaccine candidates, two therapeutics, and one 
diagnostic. Additionally, the SNS recently launched a public-private 
partnership to create a U.S.-based, high-speed, high-volume emergency 
drug packaging solution. The new consortium for Rapid Aseptic Packaging 
of Injectable Drugs, or RAPID, will enable the SNS to fill and finish, 
on a rapid basis, hundreds of millions of prefilled syringes to respond 
quickly and efficiently to widespread health emergencies, such as the 
novel coronavirus outbreak. Projects are under evaluation to expedite 
this process and could yield results within 6 months.
    Question. Can you speak to the importance of a dedicated U.S. 
manufacturing capacity for coronavirus vaccines and treatments?
    Answer. The increasing number of active pharmaceutical ingredient 
(API) manufacturing sites in China and other countries suggests that 
the United States' reliance on Chinese and other foreign sources of API 
is growing. FDA has been working diligently in collaboration with 
industry and other Federal agencies to ensure that our reliance on 
foreign manufacturing does not pose a national security risk. While FDA 
cannot tell industry where they can and cannot manufacture APIs, the 
Agency can work with industry to utilize new technologies and new 
manufacturing methods to further incentivize domestic production of 
drugs and APIs. These new ways of making drugs could, with the proper 
strategies, revitalize pharmaceutical manufacturing in the United 
States.
    Advanced manufacturing has the potential to bring greater 
efficiency and accuracy to the pharmaceutical manufacturing process. 
With increased U.S. investment, advanced manufacturing can help 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. Furthermore, advanced 
manufacturing can help improve the agility, flexibility, reliability, 
and reduce the cost of manufacturing processes for vaccines, cell and 
gene therapies, and other complex biological products. Advanced 
manufacturing can help to create a more robust manufacturing process 
with fewer interruptions in production, fewer product failures (before 
or after distribution), and greater assurance that the biologic 
products manufactured will provide the expected clinical performance. 
For example, with advanced manufacturing methods the vaccine supply 
could be more easily ramped up on short notice, and certain vaccines 
could be rapidly modified so that, once FDA-approved, they can be used 
to address emerging infectious diseases. The application of this kind 
of enabling technology to vaccine production has long been a strategic 
priority for the U.S. to help address both seasonal influenza and 
emerging infectious diseases.
    In fiscal year 2019, Congress approved appropriations to promote 
domestic manufacturing with the intent that FDA advance modern drug and 
biological product technologies. The spending plan for these additional 
resources builds on FDA's goals to improve overall staff understanding 
and expertise in advanced manufacturing by expanding support for these 
innovative technologies in assessment, policy, surveillance, and 
research, as well as by making programmatic improvements. In addition, 
this funding is used to reinforce extramural outreach with stakeholders 
via planned technology forecasting activities with the National 
Academies of Sciences, Engineering, and Medicine and other forums. 
Additionally, to support the application of novel technologies for 
advanced manufacturing, FDA enhanced its work on advanced manufacturing 
in its intramural regulatory science program and made several awards to 
support new efforts to foster innovation in the development and 
creation of more modern, domestically-based manufacturing of complex 
biologics. These efforts help encourage the establishment of high-tech 
manufacturing platforms in the U.S. and help bridge the knowledge and 
experience gaps in the adoption of emerging manufacturing technologies 
in the biological product sector.
    It is important to reduce our reliance on foreign manufacturers. 
BARDA has supported domestic manufacturing capabilities for over a 
decade. Domestic manufacturing capabilities ensures we can develop 
products, as soon as they are available, without depending on 
international partners. In past outbreaks like H1N1 in 2009, we 
witnessed firsthand international partners shutting boarders and not 
supplying products.
    Question. Secretary Azar, as we ramp up the U.S. response to this 
coronavirus outbreak, I hope we keep in mind the lessons of past 
response efforts. The Zika outbreak is a good example. As Zika became a 
significant public health threat in the U.S., Congress appropriated a 
small, one-time supplemental funding package. This funding was enough 
to sustain the initial response effort and begin a few clinical trials 
for a Zika vaccine. But after the Zika outbreak began to subside, this 
funding quickly expired. As a result, we still don't have an approved 
Zika vaccine and we don't have commercial partners to help develop one.
    What progress have we actually made in developing a Zika vaccine if 
the virus were to come back?
    Do you think this is an example of how we need to have sustained 
funding for emerging infectious diseases, even when they aren't on the 
evening news?
    Answer. The National Institute of Allergy and Infectious Diseases 
(NIAID), a component of the National Institutes of Health, supports a 
comprehensive portfolio of basic, translational, and clinical research 
on emerging and re-emerging infectious diseases, including Zika virus. 
In fiscal year 2019, NIAID committed $131.9M for research on Zika and 
other related viruses, like dengue and West Nile virus, including 
$54.6M specifically for research on the Zika virus. The outbreak of 
Zika virus in the Americas and the response by the scientific and 
public health communities provided important lessons on how to prepare 
for and confront emerging and re- emerging pathogens in the future, and 
to make sure we are prepared for the next outbreak with critical 
diagnostics, vaccines, and therapeutics.
    NIAID conducts and supports research on platform technologies that 
can quickly be modified for use during outbreaks of pathogens like Zika 
virus or the recent novel coronavirus that causes COVID-19. One such 
platform was used by the NIAID Vaccine Research Center to modify an 
investigational DNA vaccine for West Nile virus that had shown promise 
in initial testing to protect against Zika virus. NIAID is currently 
supporting a large, multi-national Phase II B clinical trial of this 
vaccine candidate, VRC5283, for Zika virus in the Americas with results 
expected within the next year. VRC5283 was recently shown to 
significantly reduce viral infection, and subsequently reduce adverse 
pregnancy outcomes, in a non-human primate model of Zika virus disease. 
NIAID also recently completed a Phase I clinical trial of a live, 
attenuated Zika virus candidate vaccine, rZIKV/D4?30-713, in 
flavivirus-naive adults. NIAID scientists have also developed a live, 
attenuated dengue virus vaccine candidate, TV003, that has shown 
promise in several Phase II clinical trials and is being evaluated in a 
large Phase III study. A single vaccine that protects from both dengue 
and Zika virus, developed by NIAID scientists, is currently in 
preclinical testing.
    NIAID also is supporting research to better understand the 
manifestations of Zika virus infection. NIAID, along with the Eunice 
Kennedy Shriver National Institute of Child Health and Human 
Development and the National Institute of Environmental Health 
Sciences, is supporting a large, prospective cohort study on Zika virus 
infection during pregnancy, called the Zika in infants and pregnancy 
study (ZIP). The ZIP study followed Zika virus-infected women and their 
infants, in ten sites in six countries, for at least 1 year after 
birth, and monitored for pregnancy outcomes, congenital anomalies, and 
other developmental abnormalities. A follow-up study is now enrolling 
that will follow these individuals for an additional one to 3 years and 
compare them to a matched Zika virus uninfected group.
    Despite the lower numbers of Zika virus cases observed recently, 
NIAID expects to see periodic outbreaks and cases of this virus in 
areas where its insect vector, the Aedes aegypti mosquito, thrives. 
NIAID will continue to prioritize this research.
    BARDA was able to support FDA clearance of four diagnostic or blood 
assay devices. In addition, BARDA supported two vaccine candidates.
    Question. Secretary Azar, I am concerned about all global health 
threats, including the threat of Ebola in the DRC and its potential to 
spread. We cannot afford to take our eye off the ball with Ebola. 
Please provide the Committee a 5 year spend plan for Ebola 
therapeutics, diagnostics and vaccines to counter this material threat.
    Answer. Future funding requests will be developed through the 
annual budget process, which takes into consideration the current 
budget environment and other Departmental priorities. NIAID supports 
development and testing of candidate products to prevent or treat viral 
hemorrhagic fevers, including those caused by Ebola. The NIAID Vaccine 
Research Center (VRC) developed a protective Ebola vaccine in 2000 and 
conducted the first Phase I clinical trial in 2003. NIAID's investments 
in vaccine development and testing supported the 2014-2016 Ebola 
outbreak response. These investments also allowed NIAID to rapidly 
launch a robust research response to this most recent outbreak in the 
Democratic Republic of the Congo (DRC). The monoclonal antibody mAb114 
(ansuvimab) was isolated from a survivor of the 1995 Ebola outbreak in 
Kikwit, DRC, and further developed by scientists at the NIAID VRC in 
partnership with the DRC's Institut National de Recherche Biomedical 
(INRB) and the U.S. Department of Defense (DoD). Ansuvimab has been 
used to successfully treat and cure hundreds of patients in the 2018-
2020 Ebola outbreak in the DRC. Critical components of the recent 
response came from products and protocols developed through the PREVAIL 
studies, which enabled the evaluation of candidate vaccines and 
therapeutics during the 2014-2016 outbreak. These NIAID-supported Ebola 
studies demonstrated the feasibility of conducting scientifically and 
ethically sound clinical research during a major public health 
emergency.
    NIAID supports the development of novel therapeutics targeting 
Ebola viruses as well as clinical trials to test the safety and 
efficacy of these treatments. NIAID worked closely with partners at 
DoD, BARDA, and the Food and Drug Administration (FDA) to advance the 
development and testing of ZMapp\TM\, and during the West African 
outbreak led a clinical trial to test the safety and efficacy of 
ZMapp\TM\ in infected people at sites in Liberia and the United States. 
Ansuvimab and ZMapp\TM\, along with the broad-spectrum antiviral 
remdesivir and a cocktail of mAbs known as REGN-EB3, were recently 
assessed in a randomized controlled trial, the Pamoja Tulinde Maisha, 
which is Swahili for ``Together Save Lives,'' (PALM) trial, in the DRC 
through a partnership between NIAID, the World Health Organization 
(WHO), and the DRC's INRB. This study was stopped early due to the 
observed safety and efficacy of REGN-EB3 and ansuvimab. An extension 
phase of the study is enrolling patients who received one of these two 
effective therapeutics. Final results from the primary study 
demonstrated statistically significant improvements in mortality for 
REGN-EB3 relative to ZMapp\TM\ and for ansuvimab relative to ZMapp\TM\.
    Safe and effective Ebola vaccines are crucial tools in the response 
to future Ebola outbreaks, especially for situations like the most 
recent outbreak, in which conflict or other factors limit the 
healthcare response. Since 1999, NIAID has pursued the development of 
multiple Ebola vaccine candidates. One such vaccine candidate, 
supported by NIAID extramural funding, rVSV-EBOV (ERVEBO(r)), a 
vesicular stomatitis virus vector expressing Ebola virus proteins, was 
used in a ring vaccination campaign in the DRC during the most recent 
outbreak to immunize frontline workers, people potentially exposed to 
Ebola virus, and individuals who may have been in contact with them. 
The NIAID supported PREVAIL 1 study also evaluated immunogenicity and 
safety of the ERVEBO(r) vaccine during the 2014-2016 West Africa 
outbreak. Another vaccine, ChAd3-EBO, was advanced by the NIAID VRC in 
Phase I clinical trials and is currently being developed by the Sabin 
Vaccines Institute. The ChAd3-EBO and ERVEBO(r) vaccines have been 
evaluated by Phase I safety testing in the United States (along with 
the Walter Reed Army Institute of Research).
    NIAID also supported the preclinical development and Phase I 
clinical evaluation of another Ebola vaccine candidate using 
Ad26.ZEBOV, which is based on an adenovirus vector expressing an Ebola 
virus protein, followed by MVA-BN(r)-Filo, a modified vaccinia virus 
expressing proteins from multiple hemorrhagic viruses. This vaccine 
regimen along with the ERVEBO(r) vaccine was evaluated in a Phase II 
study called Partnership for Research on Ebola VACcination (PREVAC) in 
Liberia, Sierra Leone, Guinea, and Mali. The ERVEBO(r) vaccine has been 
approved by the FDA and represents the first vaccine approved in the 
U.S. for use against Ebola. The data needed to support licensure of the 
Ad26.ZEBOV/MVA-BN-Filo vaccine candidate was submitted to the European 
Medicines Agency at the end of 2019 and is expected to be submitted to 
the FDA in 2021.
    NIAID is advancing the development of diagnostics capable of 
detecting an array of viruses including Ebola. Many use novel 
technologies like aptamer-based capture molecules, microfluidics, 
optofluidics, nanohole biosensors, nanophotonics, and real-time 
monitoring. NIAID investigators, have worked with collaborators at the 
DRC's INRB to implement assays developed with support from NIAID and 
partners, including the Xpert(r) Ebola PCR test and an immunoassay for 
vaccine studies.
    NIAID remains committed to supporting highly meritorious research 
on Ebola virus countermeasures. The research performed during the most 
recent outbreak will help us to rapidly respond to future outbreaks of 
Ebola and other emerging infectious diseases.
    Together with academia, industry, and national and international 
partners, NIAID will leverage lessons learned during prior outbreaks to 
continue to conduct and support high- priority research leading to 
diagnostics, therapeutics, and vaccines for Ebola. NIAID will continue 
to work closely with our global partners to gain a better understanding 
of the pathophysiology of Ebola virus infection and develop safe and 
effective medical countermeasures to treat and prevent Ebola.
    Question. Secretary Azar, I was delighted to see the Administration 
put forward a request for almost $2.5 billion last night to help combat 
coronavirus, which we know is threatening the health and safety of all 
Americans. However, I'm concerned about the suggestion in the 
administrations letter that we offset some of the funds by using 
unspent Ebola funds. I understand the desire to be fiscally responsible 
but I believe that we must not take our eye off of the threat of Ebola 
just because it's off of the front pages. We know that a global health 
threat somewhere is a health threat to all Americans so I hope we in 
Congress can find other sources of funds.
    Answer. HHS is not redirecting Ebola funds at this time. 
Appropriated funding for Ebola will continue to support investment in 
vaccines and therapeutics as planned.
    Question. Secretary Azar, Last year, the fiscal year 2020 
appropriations bill included language expressing the concern of the 
Committee that relapse following opioid detoxification is a 
contributing factor to the overdose crisis. SAMHSA has previously 
included language in grant notices stating that if funds are used to 
support detoxification it must be done in conjunction with relapse 
prevention medications. I applaud SAMHSA's action on this, however 
there was concern that this recommendation was limited to a small 
number of patients undergoing detoxification. The committee directed 
SAMHSA to go beyond just this narrow grant population and emphasize 
that all patients undergoing opioid detoxification should be made aware 
of the benefits of relapse prevention. Can you provide an update as to 
what the Department is doing to disseminate this recommendation and 
ensure that all patients, including those in rehabilitation and 
criminal justice settings, are aware of the recommendation?
    Answer. SAMHSA's grant programs that directly respond to the opioid 
crisis increase access to medication-assisted treatment using FDA-
approved medications for the treatment of opioid use disorder (OUD) 
with appropriate behavioral supports, reduce unmet treatment need, and 
reduce opioid overdose related deaths through the provision of 
prevention, treatment and recovery activities for OUD. In addition, 
SAMHSA requires that its Center for Substance Abuse Treatment's 
services programs addressing substance use disorders and co-occurring 
mental disorders--including its criminal justice programs--support 
medication-assisted treatment and other clinically appropriate services 
to achieve and maintain abstinence. Regarding the use of naltrexone 
following opioid detoxification, SAMHSA updates its website to ensure 
that the most up-to-date information on naltrexone--to include its uses 
and applicable settings--is available to consumers and practitioners. A 
video for practitioners on the use and benefits of naltrexone is also 
being developed.
    Question. Secretary Azar, as you know, independent community 
pharmacies serve on the front lines as healthcare providers and play an 
integral role as part of the Medicare Part D benefit. These small 
business providers are plagued with retroactive ``pharmacy DIR fees''. 
This creates severe difficulties in terms of business operations and 
cash flow. In fact, CMS has recognized the issues with how DIR fees are 
reported by part D plan sponsors, how these fees impact pharmacy 
business, and the resulting challenges they create for Part D 
beneficiaries. In addition, a new report by XIL Consulting, which is 
run by a former Express Scripts executive, focuses on how PBMs are 
gaming the system with these fees that are hurting pharmacies and 
patients. According to the report, payers and PBMs are profiting from 
these obscure pharmacy fees at a rate in excess of 500 percent per 
prescription as compared to the average PBM administration fee. PBMs 
are exploiting a loophole in the Part D program rather than offsetting 
prescription costs for seniors.
    The report points out that in 2017, PBMs used the fees to squeeze 
more than $4 billion out of pharmacies. That practice, according to a 
recent National Community Pharmacists Association survey, is the main 
reason 58 percent of local pharmacists are not sure they can survive 
the next 2 years. Given the fact that these ``fees'' are detrimental to 
Part D beneficiaries and Part D pharmacy care providers, how will you 
work to resolve these concerns?
    Answer. In the CY 2020 Medicare Advantage and Part D Drug Pricing 
Proposed Rule (CMS-4180-P) CMS solicited comment on a policy that would 
re-define negotiated price as the baseline, or lowest possible, payment 
to a pharmacy. The negotiated price for a drug is the price reported to 
CMS at the point of sale, which is used to calculate beneficiary cost-
sharing and generally adjudicate the Part D benefit. Although CMS did 
not implement this policy for 2020, the agency appreciates the over 
4,000 comments that were received on this potential policy approach. 
CMS is continuing to carefully review these comments and to consider 
policies that would lower prescription drug costs, address challenges 
that independent pharmacies face, and improve the quality of pharmacy 
care.
    Question. Secretary Azar, Pharmacy DIR fees have been the subject 
of the drug pricing debate and their reform has been touted as a 
possible solution to lower out of pocket costs for beneficiaries. CMS 
has recognized it has the authority to regulate whether these pharmacy 
price concessions can be included in the negotiated price at point of 
sale in Medicare Part D in order to lower out of pocket costs. Do you 
support this proposal? Further, do you support CMS' authority to 
regulate the negotiated price in Medicare Part D by requiring all 
pharmacy price concessions be included at the point of sale of the 
drug? Do you also support the complete elimination of pharmacy DIR 
fees?
    Answer. In the CY 2020 Medicare Advantage and Part D Drug Pricing 
Proposed Rule (CMS-4180-P) CMS solicited comment on a policy that would 
re-define negotiated price as the baseline, or lowest possible, payment 
to a pharmacy. The negotiated price for a drug is the price reported to 
CMS at the point of sale, which is used to calculate beneficiary cost-
sharing and generally adjudicate the Part D benefit. Although CMS did 
not implement this policy for 2020, the agency appreciates the over 
4,000 comments that were received on this potential policy approach. 
CMS is continuing to carefully review these comments and to consider 
policies that would lower prescription drug costs, address challenges 
that independent pharmacies face, and improve the quality of pharmacy 
care.
    Question. Secretary Azar, The President and your agency have 
specifically focused on concerns with the ``middlemen'' in the drug 
supply chain, also known as Pharmacy Benefit Managers or PBMs. Over 
time, these companies have morphed into under-regulated entities that 
exploit their strategic position in the middle of nearly all drug 
transactions in the U.S. to extract profits from upstream and 
downstream trading partners while providing questionable value to the 
consumer. PBMs are also heavily involved in and reap enormous profits 
from their involvement in Federal supported or subsidized healthcare 
programs, while the government has very little oversight over PBM 
actions. Do you support more regulation of PBMs in government programs 
and what does that regulation look like?
    Answer. We are open and eager to work with legislators on both 
sides of the aisle to address the high cost of prescription drugs.
  --We would support a bipartisan and bicameral plan that would bring 
        down the high costs of prescription drugs.
  --Our priorities remain: (1) Lowering drug prices, (2) Lowering 
        patients' out-of-pocket costs, (3) Improving competition, and 
        (4) Creating better conditions for negotiation.
  --We share Congress's goal of increasing transparency in the 
        healthcare system.
  --The status quo cannot remain and we will continue to offer 
        technical assistance to lawmakers as they work to find a path 
        forward.
    Question. Secretary Azar, Many States have increased their 
oversight and regulation of Medicaid managed care programs, realizing 
that Pharmacy Benefit Managers or PBMs are pocketing billions in 
``spread'' to the detriment of State funded programs, providers, 
patients and taxpayers. Currently, there are Federal legislative 
proposals to ban ``spread'' in all Medicaid managed care programs and 
reimburse providers to cover their acquisition cost of drugs and 
related dispensing costs. Do you support these proposals?
    Answer. We are open and eager to work with legislators on both 
sides of the aisle to address the high cost of prescription drugs.
  --We would support a bipartisan and bicameral plan that would bring 
        down the high costs of prescription drugs.
  --Our priorities remain: (1) Lowering drug prices, (2) Lowering 
        patients' out-of-pocket costs, (3) Improving competition, and 
        (4) Creating better conditions for negotiation.
  --We share Congress's goal of increasing transparency in the 
        healthcare system.
  --The status quo cannot remain and we will continue to offer 
        technical assistance to lawmakers as they work to find a path 
        forward.
    Question. Transparency is critical. COVID-19 has taught us that 
understanding genomic sequencing and the origins of emerging infectious 
diseases as soon as they emerge is critical for effective vaccine 
development. However, it has come to our attention that although the 
CDC largely makes the RNA sequence of influenza viruses available, the 
antigenic information including detailed source data is not made 
available to researchers for use outside the agency. The availability 
of this information could lead to faster and more effective vaccine 
development. We have additionally learned that similar information is 
shared publicly in the UK by its public health agency.
    Why does the CDC not share this information with the broader 
research community?
    Answer. CDC is committed to publicly sharing influenza data in a 
timely manner for the benefit of the broader scientific community. As 
recognized, influenza genetic sequence data is now shared rapidly 
because the CDC has moved to a 'Sequencing First' paradigm to rapidly 
disseminate this information to the community via public databases. 
This genetic data is available because of arrangements with domestic 
and international partners to share the data, including through a 
specific database (GISAID/EpiFlu https://www.gisaid.org/) that 
recognizes originating laboratory contributions.
    CDC also shares influenza antigenic data publicly in the form of 
scientific publications and other publicly available reports. To 
provide information to the broader scientific community, antigenic 
information is incorporated into a publicly available analysis (https:/
/nextstrain.org/flu/seasonal ) through a collaboration supported by the 
CDC. This analysis shows the real-time tracking of influenza viruses 
based on a variety of different parameters, including genetic and 
antigenic data, using analytic and visualization tools to aid 
epidemiological understanding and improve outbreak response. The source 
information, or strain name (e.g., A/Pennsylvania/1020/2019), 
associated with each data point is available in the analysis; however, 
some source information is deemed Personally Identifiable Information, 
and is therefore not included in public reports.
    Question. Does CDC have plans to be more transparent in the future?
    Answer. CDC is committed to transparency and communication of 
available data to inform evidence- based public health decisions, as 
evidenced by its collaboration with NextStrain to provide real- time 
tracking of influenza viruses to aid epidemiological understanding and 
effective control of influenza. Further, CDC continues to improve its 
frequency of publications to make data available more rapidly and to 
leverage technological advances and collaborations to enhance its data 
sharing capabilities, including through creating better online user 
interfaces.
                                 ______
                                 
              Questions Submitted by Senator Patty Murray
                     cdc suicide prevention program
    Question. The budget eliminates a suicide prevention program at the 
CDC that was established in the fiscal year 2020 Bill. This elimination 
is particularly disturbing in light of the recent CDC National Center 
for Health Statistics Report on life expectancy, which showed that 
suicide rates continue to increase and serve as a major contributor to 
the leading causes of death in the U.S. This suicide prevention program 
supports a comprehensive public health approach to suicide prevention 
focused on these vulnerable populations, including veterans, rural 
communities, tribal populations, LGBTQ youth and the homeless, all of 
which have suicide rates higher than the general population. Suicide is 
a national public health crisis that requires a comprehensive evidence-
based prevention approach and yet this budget eliminates the 
initiative. Please provide CDC's analysis of how many people, 
representing which vulnerable populations, will be affected if the 
agency eliminates this suicide prevention program in fiscal year 2021.
    Answer. CDC has prioritized suicide prevention for many years. With 
a dedicated funding line for suicide in fiscal year 2020, CDC is 
expanding its ability to provide data for States and communities to 
understand who dies by suicide, why, and how to prevent it. Towards 
that goal, CDC published a new notice of funding opportunity forecast 
on grants.gov that will fund States and emphasize vulnerable 
populations. CDC will not know which populations, including vulnerable 
populations will be the focus of this funding, until after applications 
are received and funded.
                             hiv initiative
    Question. The budget expands the initiative Congress started last 
year aimed at ending our Nation's HIV epidemic in the next decade 
through modest, but focused, increases for the Centers for Disease 
Control and Prevention, the Indian Health Service, and the Ryan White 
HIV/AIDS Program. However, the budget's deep cuts to the Medicaid 
program would undermine efforts to eliminate new infections. The 
President's efforts to repeal the Affordable Care Act and more than 
$1.5 trillion in cuts to Medicaid and Medicare would greatly reduce 
access to healthcare for people living with HIV, hurting efforts to end 
the epidemic domestically. Ending the HIV epidemic will require 
affordable, comprehensive health coverage and a robust and sustainable 
healthcare system, which are at odds with the Administration's 
proposals and efforts. Please provide HHS' analysis of how many people 
living with HIV/AIDS will be affected if the Administration is 
successful at striking down the ACA and Medicaid expansion?
    Answer. The Budget does not propose cutting Medicaid, but rather 
maintains funding to at least fiscal year 2020 levels and slows annual 
growth of the program from 5.4 percent to 3.1 percent. The Ending the 
HIV Epidemic Initiative ensures that those who need treatment get 
treatment, and those who need prevention tools get those as well. The 
Budget proposes $716 million for fiscal year 2021, an increase of $450 
million, to expand HIV testing and access to prevention and treatment 
services. This additional $450 million is disbursed between the 
following agencies: a $231 increase to CDC's community partnerships to 
effectively diagnose, prevent, and respond to HIV infections; a $182 
million increase to HRSA's Health Center and Ryan White activities to 
increase access to treatment, prevention services, and retain people 
with HIV in care; a $27 million increase for IHS activities, including 
treatment, medication, public health surveillance, and data 
infrastructure efforts; and a $10 million increase to NIH to lead 
evaluation efforts to identify effective interventions to treat and 
prevent HIV. Additionally, last December HHS launched Ready, Set, PrEP, 
a national program that makes these PrEP medications available at no 
cost to individuals who lack prescription drug insurance coverage.
                            maternal health
    Question. The budget expands the initiative Congress created in 
2018 aimed at ending our Nation's maternal mortality crisis, which 
kills approximately 700 women each year. Every mother is at risk here, 
however Black and Native American, women are disproportionately at 
risk. Despite these risks, the budget's deep cuts to the Medicaid 
program would undermine efforts to eliminate this largely preventable 
public health crisis, as nearly half of all U.S. births are covered by 
Medicaid. The President's efforts to repeal the Affordable Care Act and 
more than $1.5 trillion in cuts to Medicaid and Medicare would greatly 
reduce access to healthcare for women seeking maternal health services. 
How can communities fight the maternal mortality crisis if you 
undermine programs so many families rely on for care? Please provide 
HHS' analysis how many women will lose access to maternal health 
services affected if the Administration is successful at striking down 
the ACA and Medicaid expansion?
    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.\1\
---------------------------------------------------------------------------
    \1\ 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.\2\
---------------------------------------------------------------------------
    \2\ 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.\3\
---------------------------------------------------------------------------
    \3\ 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, wellbeing, 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).\4\ 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 (Public Law 115-123), 
State reporting of the Child Core Set, including maternal and infant 
health measures, will become mandatory beginning in 2024.
---------------------------------------------------------------------------
    \4\ 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.\5\ 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.
---------------------------------------------------------------------------
    \5\ Available at: https://www.medicaid.gov/state-overviews/
scorecard/index.html.
---------------------------------------------------------------------------
         global health/public health preparedness and response
    Question. This budget cuts funding to the CDC by nearly $700 
million and while it increases funding for Global Health Security, it 
comes at the cost of deep funding cuts to other global health and 
public health preparedness and response programs. In 2019, the U.S. 
experienced several large measles outbreaks. Ultimately, there were 
1,261 cases in thirty-one States linked to travelers who brought 
measles back from other countries. Since 2000, when measles was 
declared eliminated from the U.S., nearly all domestic cases have been 
linked to international travel. We know that vaccines are cost-
effective and that Americans remain at risk from other vaccine-
preventable diseases like polio and pertussis. Yet, this budget cuts 
the global immunization program by $20 million. How many countries and 
international partnerships are supported by the global immunization 
program? How many children and adults are served by these programs? 
Please provide CDC's analysis of how many children and adults would 
lose access to immunizations services if the global immunization 
program were cut by $20 million.
    Answer. CDC's global immunization program provides support to 64 
countries as part of two international partnerships, the Global Polio 
Eradication Initiative (GPEI) and the Measles and Rubella Initiative 
(M&RI). To address increases of vaccine-derived polio outbreaks, CDC is 
intensifying focus-deploying an additional 97 technical experts since 
2019. To address global measles outbreaks, CDC experts work with in-
country and other global partners to analyze data, plan and implement 
outbreak response immunization campaigns, conduct laboratory analysis, 
and build surveillance capacity to detect and contain outbreaks 
quickly. In 2019, CDC supported measles activities in 14 countries, 
leading to 26 million people receiving measles vaccine. In February 
2020, CDC's Center for Global Health activated the Measles Incident 
Management System (MIMS) to focus additional effort on countries with 
large measles outbreaks and a high number of deaths.
    In fiscal year 2019, CDC provided approximately 75 million doses of 
oral polio vaccine, 1 million doses of inactivated polio vaccine, and 
72,800 doses of measles-containing vaccine totaling $15.1 million. CDC 
reached another 18.5 million children through an effort to provide 
vaccines to children for $1 per child ($18.5 million).
    On March 17, 2020, the Administration transmitted an fiscal year 
2021 Budget Amendment to Congress to increase funding for CDC to ensure 
that the Agency has the resources beginning October 1, 2020, to 
continue its critical public health mission. This amendment requests a 
total fiscal year 2021 funding level of $8,329,102,000 for CDC, which 
is $1,328,196,000 above the fiscal year 2021 Budget request. The 
additional funding will support priority CDC activities, including 
global health.
    Question. Our public health preparedness and response programs 
build and maintain the infrastructure necessary to protect Americans 
during public health emergencies. This budget cuts CDC's Public Health 
Preparedness and Response programs by $25 million. These cuts risk 
undermining the agency's ability to support efforts to detect, respond 
to, and contain epidemic threats like the novel coronavirus. Please 
provide CDC's analysis of how a $25 million cut to Public Health and 
Preparedness programs would affect our preparedness and response 
capabilities to support rapid analysis and exchange of syndromic data, 
medical countermeasures, biosurveillance, community resilience, 
incident management, information management, and surge management.
    Answer. On March 17, 2020, the Administration transmitted an fiscal 
year 2021 Budget Amendment to Congress to increase funding for CDC to 
ensure that the Agency has the resources beginning October 1, 2020, to 
continue its critical public health mission. This amendment requests a 
total fiscal year 2021 funding level of $8,329,102,000 for CDC, which 
is $1,328,196,000 above the fiscal year 2021 Budget request. The 
additional funding will support priority CDC activities, including 
preparedness and response.
    CDC will continue to focus on evaluation and program improvement 
through PHEP program activities such as Operational Readiness Reviews, 
and after-action reports on CDC response activities. CDC will continue 
to fund research for both CDC and its state and local partners to 
efficiently and effectively prepare for, respond to, and recover from 
public health emergencies and disasters. This research focuses on three 
broad areas: preparedness and response capabilities, emergency 
management activities, and factors affecting individual and community 
resilience to disasters and other adverse public health events.
    CDC's request for Preparedness and Response Capabilities will 
continue to support critical infrastructure and research to facilitate 
prevention of and response to public health emergencies. These 
activities include:
  --Developing and exercising the preparedness capabilities upon which 
        responses are built. This preparation impacts CDC's ability to 
        surge to meet new and emerging threats.
  --CDC's intramural preparedness and response program. Examples of 
        recent work funded through this program include:
    --Researching the most effective use of medical countermeasures to 
            inform clinical guidance and national decisionmaking for 
            prevention and treatment.
    --Improvement of surveillance systems, processes, and strategies to 
            increase the efficiency and effectiveness of the emergency 
            response structure.
    --The Children's Preparedness Unit, which serves as a key asset in 
            addressing children's needs in public health emergencies.
  --Applied research to help protect first responders, such as 
        evaluating personal protective equipment effects and 
        capabilities to protect against newly identified chemical and 
        radiological threats.
  --Chemical terrorism response including maintaining and upgrading CDC 
        laboratory response capacity.
  --Training for laboratories regulated under CDC's Select Agent 
        Program, to support them in improving compliance and increasing 
        biosafety and biosecurity.
  --Inspections of these laboratories and other facilities that import, 
        store, and manage infectious biological agents, to support 
        essential research continuing with as little risk as possible.
  --Continuing to build and develop preparedness for nuclear or 
        radiological incidents. This includes training, exercising, and 
        equipment to ensure CDC is ready to provide the expertise and 
        guidance that State, local, and territorial health departments 
        will need following this type of emergency.
  --Smallpox research, including ensuring the availability of 
        diagnostics that would be critical for early detection and 
        recognition of smallpox if it were to be reintroduced.
                       child care and head start
    Question. President Trump's fiscal year 2021 budget re-proposes a 
one-time, $1 billion investment for building the supply of child care 
in underserved communities. In order to be eligible for a grant, States 
would be required to identify and describe steps they will take to 
reduce regulatory requirements. Would the funds in this one-time 
proposal be subject to the health, safety and quality standards that 
were agreed to on a bipartisan basis in the Child Care Development 
Block Grant Act of 2014?
    Answer. The one-time, $1 billion, investment is not intended to 
provide child care subsidies and direct services. Rather, the supply 
building activities specifically support the development of licensed 
family child care providers as a small business and entrepreneurship 
opportunity, provide incentives for businesses to develop cost 
effective models to offer child care support to their employees, and 
promote innovation and modernization of the child care business model. 
Health and safety requirements and quality standards will continue to 
apply to any subsidies/direct services funded by the Child Care and 
Development Fund (CCDF). Eliminating regulations and barriers are 
needed to maintain quality and reduce costs.
    Question. On January 30, 2020, the Secretary exercised his 
authority to reduce service duration requirements for Head Start 
programs. The Secretary lowered the required percentage of a program's 
center-based slots that must operate for 1,020 hours or longer per year 
from 100 percent of slots to 45 percent of slots. The Office of Head 
Start assessed that 78 percent of Head Start center-based programs 
currently operate at least 45 percent of their slots at 1,020 hours per 
year. What steps is the Department taking to ensure that Head Start 
programs that are not currently meeting this requirement are able to 
meet the new service duration requirements by August of 2021? How much 
does the Department estimate that it would cost to bring these 
remaining programs up to the required 45 percent threshold?
    Answer. The Office of Head Start (OHS) is working to make sure 
grantees are aware that the requirement has been lowered from 100 
percent to 45 percent of a program's center-based slots needed to meet 
1,020 annual hours. In addition to officially lowering the requirement 
through the Federal Register Notice, OHS issued Program Instruction 
(PI) to grantees to further explain the lowered requirement. In the PI, 
OHS reminded programs that if they do not believe longer service 
duration best fits the needs of their community, then they can submit a 
waiver with an appropriate rationale to justify this, as required in 
the Head Start Program Performance Standards. OHS is also clarifying 
the requirement verbally for grantees as well as through alternate 
paths (waivers, locally designed options, etc.) conference 
presentations, webinars, and other formats. In addition, OHS is 
communicating to grantees that the fiscal year 2020 quality funding can 
be used to extend service duration for children, as allowed under the 
Head Start Act.
    We estimate that it would cost approximately $150 million to bring 
up the remaining grantees to meet the 45 percent requirement. In this 
estimate we adjusted for recent funding increases such as the fiscal 
year 2020 COLA and quality funding.
    Question. Has the Department provided any guidance directly to 
child care providers, Head Start grantees, families, and other social 
service providers about how they can prepare to respond to COVID-19?
    Answer. OHS sent two e-blasts on March 6th and March 12th to all 
Head Start grantees regarding the Coronavirus Prevention and Response. 
The e-blasts provide prevention strategies, preparedness, and treatment 
information as it relates to COVID-19. OHS also held a conference call 
on March 3rd with the OHS Regional Program Managers (RPMs) where OHS 
Director Dr. Deborah Bergeron and Deputy Director Ann Linehan provided 
guidance to the RPMs regarding how the Regional Offices should be 
responding to grantee inquiries. The content aligned with the attached 
emails informing grantees to review CDC resources, reach out to their 
State and local health authorities, and work with their Health Services 
Advisory Committee.
  --OHS updated its website's landing page, the Early Childhood 
        Learning and Knowledge Center, with information grantees and 
        families can easily access.
  --OHS is also directing grantees to an Information Memorandum 
        published last year that answers questions about how they may 
        use flexibilities and waivers in the Head Start and Early Head 
        Start program to address the impact of the COVID-19 (General 
        Disaster Recovery Flexibilities ACF-IM-HS-19-01).
  --Dr. Bergeron recorded a VLOG for grantees, highlighting resources, 
        good health and safety practices, and linking to the General 
        Disaster Recovery Flexibilities for reference.
  --In addition, OHS is sharing information from the CDC with grantees 
        regarding COVID-19, such as this helpful resource: https://
        www.cdc.gov/coronavirus/2019-ncov/specific-groups/guidance-for-
        schools.html.
    The Office of Child Care (OCC) has received questions from States, 
territories, and tribes regarding how they may use flexibilities and 
waivers in the CCDF program to address the impact of the coronavirus. 
We have been referring these grantees to an existing Information 
Memorandum on Flexibility in Spending CCDF Funds in Response to Federal 
or State Declared Emergency Situations (CCDF-ACF-IM-2017-02; https://
www.acf.hhs.gov/occ/resource/im-2017-02). This Information Memorandum 
outlines the options available to Lead Agencies to use CCDF funds to 
address emergencies, which include:
  a.  Changing eligibility or priority criteria to permit uninterrupted 
        child care;
  b.  Defining income and setting the income threshold for purposes of 
        CCDF eligibility;
  c.  Waiving family co-payment requirements for families that meet 
        criteria established by the Lead Agency--which may include, for 
        example, families impacted by Federal or State declared 
        emergency situations; and
  d.  Using quality dollars to provide immediate assistance to impacted 
        families. In some cases, States may need to enact State 
        legislation or regulation in order to take advantage of these 
        flexibilities.
    OCC has also received questions about steps that should be taken by 
local child care programs and providers. We have referred these 
inquiries to guidance from the Centers for Disease Control and 
Prevention (CDC) as well as State and local public health officials.
    OCC is preparing to issue an announcement through its email 
distribution list to remind CCDF Lead Agencies and stakeholders of 
these resources.
    OCC is sharing input with CDC regarding the informational needs of 
child care grantees and stakeholders to inform future messaging.
                                  uac
    Question. The President's fiscal year 2021 budget request includes 
additional funding to ``support a capacity of 16,000 licensed permanent 
beds, depending on the operational need, as well as the periodic 
activation of influx shelter sites if they are needed''. How does ORR 
plan to create additional capacity in its permanent network? What steps 
will ORR take to open additional licensed shelters and to recruit 
additional licensed transitional foster care families?
    Answer. ORR is using the Funding Opportunity Announcement (FOA) 
process to expand its network of State-licensed shelters and 
transitional foster care (TFC) programs. ORR just awarded grants for 
basic shelter and TFC from the FOA advertised in November 2019. In 
total, ORR approved grants for 6,300 shelter and transitional foster 
care bed capacity with a total grant budget of $728 million. ORR will 
have additional FOAs for specialty bed and long term foster care 
capacity this spring. ORR will seek to maintain original awarded 
capacity levels for specialty beds and long term foster care.
    Question. The fiscal year 2020 explanatory statement that 
accompanied the final conference report directed ORR to provide in the 
fiscal year 2021 Congressional Justification information on efforts to 
ensure developmentally appropriate care for tender age children, 
including placement options, services and staff training, as well as an 
assessment of circumstances under which very young children are 
referred to ORR. This information was not adequately provided.
    Answer. ORR's efforts to ensure developmentally appropriate care 
for tender age children begins when ORR receives the initial referral 
of the child. ORR Intakes critically reviews the information provided 
by the referring agency and uses that information to determine the most 
appropriate placement in ORR's care provider network. ORR programs that 
accommodate all children, including tender age children, are licensed 
by the State in which they operate to provide a safe and 
developmentally appropriate environment for children of this age group. 
ORR Intakes only places children in programs that are licensed to care 
for children of their age and any special care needs known at the time 
of referral. Young children are prioritized for placement in 
Transitional Foster Care programs, following ORR policy.
    Question. What changes is ORR making to ensure that young children 
in ORR care are receiving care that is developmentally appropriate, 
especially for children under the age of 5?
    Answer. All children who are admitted into ORR care are interviewed 
by care provider staff who are trained to interview children in a child 
friendly, culturally sensitive way. Consistent with the Flores 
Settlement Agreement (FSA), all children receive appropriate routine 
medical and dental care, including a complete medical examination 
(including screening for infectious diseases) within 48 hours of 
admission.
    Additionally, children receive an individualized needs assessment, 
which includes the various initial intake forms, when they arrive at an 
ORR shelter. This includes collection of essential data relating to the 
identification and history of the child and his or her family, 
identification of the child's special needs including any specific 
problems that appear to require immediate intervention, an educational 
assessment and plan, an assessment of family relationships and 
interaction with adults, peers and authority figures. Also included is 
a statement of religious preference and practice; an assessment of the 
child's personal goals, strengths and weaknesses; identifying 
information regarding immediate family members, other relatives, 
godparents or friends who may be residing in the United States and may 
be able to assist in connecting the child with family members. While in 
ORR care, and in accordance with the principles and provisions 
established by the FSA, each child also receives an individual service 
plan (ISP) that identifies placement and case outcome goals, tailored 
to their needs and age, with the child's best interests in mind.
    Furthermore, children receive at least one individual counseling 
session per week conducted by trained social work staff with the 
specific objective of reviewing the child's progress, establishing new 
short-term objectives, and addressing both the developmental and 
crisis- related needs of each child. For complete information on the 
services children receive, please see 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). All services are provided in a manner that is appropriate to 
the age and individualized needs of the child, by care providers who 
are State-licensed to provide appropriate care.
    Question. Please also provide an assessment of circumstances under 
which very young children are referred to ORR.
    Answer. ORR receives referrals for very young children (e.g. under 
5) in a variety of circumstances. In fiscal year 2020, ORR received 373 
referrals of children between 0-5 years of age. Examples of frequently 
encountered situations are outlined below:
  --Babies of teen UAC, who are placed in ORR care together with their 
        parent.
  --Children who have been separated from a parent by DHS for reasons 
        such as parent's criminal history, the parent was referred for 
        prosecution, or the parent required hospitalization.
  --Children who were apprehended with an adult who is not their parent 
        or legal guardian (e.g. an aunt or grandmother).
  --Groups of minors that include a young UAC (e.g., sibling groups).
                                capta/ao
    Question. Across the country, there is an urgent need to reduce the 
number of child fatalities and near fatalities that occur due to child 
abuse and neglect. In 2016, the Commission to Eliminate Child Abuse 
Fatalities recommended that the establishment of uniform definition 
standards for child fatalities from maltreatment to be used by States 
to report more accurate and consistent data to the National Child Abuse 
and Neglect Data System (NCANDS).
    What is the Secretary doing to improve the quality of child 
fatality and near fatality data collection efforts, and how will the 
Department hold States and local child welfare systems accountable for 
improving public reporting?
    Answer. The National Child Abuse and Neglect Data System (NCANDS) 
was established as a voluntary system. States report certain data 
elements to the Children's Bureau via NCANDS ``to the extent 
practicable,'' meaning there are not any fines or penalties for not 
reporting one or more fields. Each year the States report data to the 
Children's Bureau, via NCANDS, about children known to child welfare 
agencies, including children who died due to maltreatment. NCANDS does 
not specifically identify near fatalities.
    To improve the child fatality data quality, States consult sources 
outside of their Child Protective Services systems for deaths 
attributed to child maltreatment. States are asked during the annual 
data submission to confirm the child fatality counts and to provide 
information about which external agencies were sourced for the 
additional fatality data. The Child and Family Services Improvement and 
Innovation Act (Public Law 112-34) lists the following additional data 
sources, which States must include a description of in their State plan 
or explain why they are not used: State vital statistics departments, 
child death review teams, law enforcement agencies, and offices of 
medical examiners or coroners. Some States also collect child fatality 
data from hospitals, health departments, juvenile justice departments, 
and prosecutor and attorney general offices. After the passage of 
Public Law 112-34, several States mentioned that they implemented new 
child death reviews or expanded the scope of existing reviews. Some 
States began investigating all unexplained infant deaths regardless of 
whether there was an allegation of maltreatment. Information about 
child fatality reviews and which additional agencies are sourced for 
fatality data may be found in the annual Child Maltreatment report in 
Appendix D, State Commentary.
    The child fatality counts in NCANDS reflects the fiscal year in 
which the deaths were determined as due to maltreatment. The year in 
which a determination is made may be different from the year in which 
the child died. The time needed to conclude if a child was a victim of 
maltreatment often does not coincide with the timeframe for concluding 
that the death was a result of maltreatment due to multiple agency 
involvement and multiple levels of review for child deaths. NCANDS 
added a field called ``maltreatment death date'' to differentiate the 
year in which the death was reported to NCANDS from the year in which 
the child died. States began reporting this field in fiscal year 2013 
data. Approximately 85.0 percent of child fatality reviews determine 
whether the death is due to maltreatment within 2 years.
    The Children's Bureau and the NCANDS Technical Team work with State 
child welfare agencies to continuously improve data quality. Webinars, 
technical bulletins, virtual meetings, email, listserv discussions, and 
phone conferences are used regularly to facilitate information sharing 
and to provide technical assistance. Upon receipt of data from each 
State, a technical validation review assesses the internal consistency 
and identifies probable causes for any missing data. If the reviews 
conclude that corrections are necessary, the State may be asked to 
resubmit its data.
    Question. Describe the Department's efforts to implement 
recommendations from the Commission's report, Within Our Reach: A 
National Strategy to Eliminate Child Abuse and Neglect Fatalities, and 
outline Congressional actions that are required to achieve the 
recommendations in the report.
    Answer. HHS provided a report to the Congress in 2016 describing in 
detail our responses to the Commission's report. That report may be 
found here: https://aspe.hhs.gov/system/files/pdf/208766/
ResponseReport.pdf. Since that report was developed, HHS has continued 
to make progress on the issues raised by the Commission. Highlights of 
these efforts include the following (organized under the topics focused 
on in the original report):
Promoting Prevention
    The Children's Bureau within ACF has made the prevention of child 
abuse and neglect a significant emphasis of their recent work. 
Implementation of the Title IV-E Prevention Services Program have been 
a particular focus. Three States and the District of Columbia currently 
have approved Title IV-E Prevention Plans and plans for another eight 
States are under review. In addition, the Children's Bureau funded 13 
Community Collaborations to Strengthen and Preserve Families in fiscal 
year's 2018 and 2019. These cooperative agreements support the 
development, implementation, and evaluation of primary prevention 
strategies to improve the safety, stability, and well- being of 
families through a continuum of community-based services and supports.
    CDC's Essentials for Childhood emphasizes the primary prevention of 
child abuse and neglect by promoting safe, stable, and nurturing 
relationships and environments. This 5-year cooperative agreement began 
in September 2018. It focuses on preventing child abuse and neglect by 
supporting State health departments (CA, CO, KS, MA, NC, UT, and WA) to 
implement complementary strategies that provide safe, stable, nurturing 
relationships and environments for all children.
    Recipients are implementing statewide comprehensive strategies and 
approaches designed to reduce child abuse and neglect (CAN) along with 
other adverse childhood experiences (ACEs) and related health 
consequences and disparities. Recipients use funding to implement 
projects that aim to decrease CAN risk factors and increase CAN 
protective factors by leveraging multi-sector partnerships and 
resources. Additionally, States have received supplemental funding to 
implement prevention strategies and activities to address risk and 
protective factors associated with opioid misuse, ACEs and CAN. Several 
recipients are partnering with and working on their State's child 
fatality review boards, taskforces, and with their State legislatures 
to communicate how their work in upstream prevention of ACEs and CAN is 
essential in eliminating child abuse and neglect fatalities.
    CDC is also working with partners to promote the use of strategies 
to plan and implement prevention of child abuse and neglect. For 
example, CDC collaborates with partner organizations to build capacity 
on INSPIRE: Seven Strategies to End Violence Against Children, a 
collection of strategies that represents the best available evidence to 
reduce violence against children. CDC's technical expertise helps 
partners and stakeholders select, plan, adapt, plan, and implement 
INSPIRE programs and strategies to address child abuse and neglect.
Finding New Solutions
    Authorized under the Family First Prevention Services Act, the 
Title IV-E Prevention Services Clearinghouse is reviewing evidence on 
the effects of programs that offer services to children at imminent 
risk of foster care entry and their families. Additional evaluations of 
programs implemented by states that have ratings less than ``well-
supported'' by the Clearinghouse will add to our evidence base about 
prevention programs. Additionally, 19 Regional Partnership Grants were 
awarded in fiscal years 2018 and 2019. These grants are intended to 
increase well-being, improve permanency, and enhance the safety of 
children who are in, or at risk of, an out-of-home placement as a 
result of a parent's or caregiver's opioid or other substance use.
    The 2016 Report to Congress had noted that the U.S. Preventive 
Services Task Force had underway a review of primary care interventions 
to prevent maltreatment. That review has been completed (available 
here: https://www.ncbi.nlm.nih.gov/books/NBK534927/) and found that, 
``overall, the evidence on interventions provided in or referable from 
primary care to prevent child maltreatment does not consistently 
demonstrate benefit.'' Additional research and program development is 
therefore needed to identify more effective interventions.
    CDC is building the evidence base for the primary prevention of 
child abuse and neglect. In fiscal year 2018, CDC funded two 
cooperative agreements that are rigorously evaluating whether previous 
or current Federal, State, local, or organizational policies are 
effective at reducing or preventing multiple forms of violence that 
affect children, youth, and/or families (i.e., child abuse and neglect, 
youth violence, intimate partner violence, sexual violence, and/or 
suicide). In addition, CDC funded four rigorous evaluations or programs 
and policies to prevent ACEs in fiscal year 2019. The projects will 
rigorously evaluate the effectiveness of a trauma-informed youth 
resiliency program, an enhanced home visiting program, low income 
housing tax credits, and family economic policies on child abuse and 
neglect.
    In addition, CDC supports existing evidence-based strategies with 
funding to 23 State health departments through Core State Violence and 
Injury Prevention Program (Core SVIPP). These efforts help States 
implement, evaluate, and disseminate evidence-based strategies that 
address the most pressing injury and violence issues including child 
abuse and neglect. The overall goal is to decrease injury and violence 
related morbidity and mortality and increase sustainability of injury 
prevention programs and practices. In addition, Core SVIPP enables 
three States to enhance their surveillance information by supporting 
data collection through the Adverse Childhood Experiences module of the 
Behavioral Risk Factor Surveillance System.
Improving Child Death Statistics
    Efforts to improve child death statistics continue on a number of 
fronts. In particular, the National Center for Health Statistics (NCHS) 
is working with medical examiners and coroners (ME/C) to improve the 
detail and consistency of vital statistics data gleaned from death 
certificates so that these data consistently and reliably identify 
deaths related to maltreatment. More generally, the Division of Vital 
Statistics at NCHS has worked on collaborations, including providing 
support for pilot programs for improvements in ME/C data systems, such 
as better interoperability between ME/C case management systems and 
electronic death registration systems. NCHS also works with other 
Federal partners to improve understanding about death investigation 
practices, data collection and automation, and death certification. For 
more details on these efforts, see the answer to item (d) in this 
series of questions.
Modernizing the Regulatory Infrastructure for Child Welfare Data and 
        Information Systems
    At the time of the 2016 report to Congress, ACF had issued final 
regulations governing Comprehensive Child Welfare Information Systems 
(CCWIS). Since then, 46 States plus the District of Columbia, and 
Puerto Rico have expressed the intent to develop or transition to CCWIS 
systems; many of those systems are currently operational and will 
support the exchange of information among State agencies to improve 
responses to child abuse and neglect.
Addressing Disproportionality (particularly by strengthening Tribes' 
        capacity to prevent and address child maltreatment)
    In August of 2017, the Children's Bureau funded the Center for 
Native Child and Family Resilience. This Quality Improvement Center 
(QIC) will gather, generate, and disseminate knowledge regarding 
effective practice models for strengths-based, culturally relevant, 
trauma-informed, and preventive services and interventions for all 
forms of child maltreatment. A total of five projects have agreed to 
partner with the QIC to build and enhance their culturally-based 
prevention and intervention efforts. Each of the projects will 
implement and assess practice models that show promise in preventing 
child abuse and neglect, and that can be implemented or adapted in 
other tribal child welfare systems. Additional information is available 
here: https://cncfr.jbsinternational.com/. In addition, in fiscal year 
2018, the Children's Bureau funded seven tribal court improvement 
programs, intended to strengthen these courts' handling of child 
welfare cases.
    HHS has included in recent Budget submissions several proposals to 
streamline and provide additional flexibility to tribes in operating 
Federal child welfare programs. To date, Congress has not acted on 
these proposals.
    Question. Describe the Department's efforts to collect more 
accurate and complete data regarding the nature of fatalities and near 
fatalities due to child abuse and neglect, including supporting 
alignment across the Department in regards to the activities of the 
National Center for Fatality Review and Prevention, which is funded by 
the Health Resources Services Administration (HRSA), Maternal and Child 
Health Bureau (MCHB), the Centers for Disease Control's National 
Violent Death Reporting System, and the National Center for Health 
Statistics.
    Answer. Efforts from the HRSA/MCHB National Center for Fatality 
Review and Prevention include the following:
  --In 2017, the National Center for Fatality Review and Prevention 
        (National Center) convened an international group of CAN 
        experts to create a guide for multidisciplinary fatality 
        reviews. The group of experts included representatives from 
        State/local child fatality (death) review, State child welfare 
        agencies, private business, child advocates, medical examiners, 
        epidemiologists, Citizen Review Panels, child abuse 
        pediatricians and child welfare organizations. Additionally, 
        the Department of Defense participated in this meeting. The 
        Administration for Children and Families (ACF) and HRSA 
        provided feedback on the written guidance prior to publication. 
        The guidance was released to the field in September 2018 and is 
        available here: https://protect2.fireeye.com/url?k=3ac1341c-
        66943d0f-3ac10523-0cc47adb5650-d6851b52efbee07f&u=https://
        www.ncfrp.org/wp-content/uploads/NCRPCD-Docs/CAN_Guidance.pdf.
  --The National Center disseminated the guidance to its network of 
        more than 1,500 local and State fatality review teams. Child 
        death review teams are comprised of multidisciplinary 
        membership often including law enforcement, coroners/medical 
        examiner, pediatricians, child welfare, public health and many 
        others. Additionally, this guidance has been used extensively 
        by Within Our Reach, a program of the Alliance for Strong 
        Families and Communities. Within Our Reach (described below) is 
        funded by Casey Family Programs to implement the 
        recommendations from the 2016 Commission Report.
  --Since the release of this guidance, the National Center has held a 
        webinar and released an infographic on CAN deaths using data 
        from the National Fatality Review-Case Reporting System. The 
        National Center promotes the CAN Guidance on its website, 
        social media and training/technical assistance work. 
        The webinar is archived and available here: https://
        protect2.fireeye.com/url?
        k=0b723585-57273c96-0b7204ba-0cc47adb5650-
        063308d21810623e&u=https://
        www.ncfrp.org/tools_and_resources/archived-webinars-
        presentations/ and the infographic is available here: https://
        protect2.fireeye.com/url?k=6340058d-3f150c9e-634034b2-
        0cc47adb5650-1cd1983d909f65f3&u=https://www.ncfrp.org/
        resources/quick-looks/. The National Center continues to be an 
        integral part of the National Coalition to End Child Abuse 
        Deaths.
  --The National Center has presented on the CAN guidance at numerous 
        State and national conferences, including the National 
        Children's Alliance conference, CityMatCH, the Association for 
        Maternal Child Health Programs conference and PREVCON. 
        Additionally, the National Center has shared this guidance at 
        the annual Department of Defense Fatality Review Summit and the 
        Federal Interagency Workgroup on Child Abuse and Neglect.
  --In 2019, the U.S. Department of Justice funded Within Our Reach to 
        provide intensive training and technical assistance to five 
        demonstration sites who are developing multidisciplinary 
        strategies and responses to address serious or near- death 
        injuries as a result of CAN. The ultimate goal of this project 
        is to reduce CAN fatalities. The National Center is part of the 
        technical assistance team supporting this project. The guidance 
        will be an integral part of this work.
    In addition, CDC's National Violent Death Reporting System (NVDRS) 
collects data from death certificates, coroner/medical examiner 
reports, law enforcement reports, and toxicology reports. These data 
provide valuable context about violent deaths, such as relationship 
problems; mental health conditions and treatment; toxicology results; 
and life stressors, including recent money- or work-related problems. 
In 2013, CDC added a variable to identify cases where abuse or neglect 
of a child led to death, in order to more readily report data on these 
cases. Further, Child Death Review/Child Fatality Review reports are 
often used by States as supplemental sources of information to add 
detail to NVDRS child death cases.
    CDC's efforts have focused on improving death statistics as 
reported by medical examiners and coroners. They have a number of 
ongoing and long-standing efforts to improve the quality and 
consistency of information reported on death certificates, with the aim 
of improving information for all causes, and some of these activities 
are focused on medical examiners and coroners (ME/C) and the critical 
role they play in providing information from investigations. The 
Division of Vital Statistics at NCHS has worked on collaborations, 
including the examples below:
  --Participating in professional conferences and workgroups with ME/C, 
        and serving as co-leads the Federal Medicolegal Death 
        Investigation Working Group (MDI-WG). This group identifies 
        both short and long term goals to develop and implement 
        programmatic activities that support the MDI system, and in 
        turn, support Federal public safety and public health national 
        initiatives.
  --Facilitating learning opportunities for ME/C on public health 
        topics like drug overdose, suicides, infectious diseases, and 
        more.
  --Providing support for pilot programs for improvements in ME/C data 
        systems, such as better interoperability between ME/C case 
        management systems and electronic death registration systems.
  --Participating in several Federal initiatives focusing on medical 
        examiners and coroners and other forensic sciences, including: 
        Member of the subcommittee on Medicolegal Death Investigation 
        https://www.nist.gov/topics/organization-scientific-area-
        committees-forensic-science/medicolegal-death-investigation 
        National Commission on Forensic Science http://www.justice.gov/
        ncfs. and DOJ's Needs Assessment of Forensic Laboratories and 
        Medical Examiner/Coroner Offices.
  --NCHS also works with other Federal partners to improve 
        understanding about death investigation practices, data 
        collection and automation, and death certification.
  --CDC is currently in the process of validating several syndrome 
        definitions, which can be used to query near real-time 
        electronic medical record data from approximately 70 percent of 
        emergency departments (EDs) across the U.S. for ED visits 
        related to CAN, child sexual abuse (CSA), and ACEs. Once 
        validated and finalized, these definitions will be disseminated 
        through the National Syndromic Surveillance Program's 
        Electronic Surveillance System for the Early Notification of 
        Community-based Epidemics (ESSENCE) platform, allowing 
        epidemiologists across the U.S. to easily query their local and 
        State-level syndromic surveillance data to identify CAN, CSA, 
        and ACEs-related ED visits.
    All of these efforts seek to improve reporting, not necessarily for 
a specific cause, but for all causes.
    Question. The President's fiscal year 2021 budget includes an 
increase of $16 million for Child Abuse Discretionary Activities to 
support demonstration projects focused on primary prevention of child 
abuse and neglect. What are the intended goals and outcomes for these 
demonstration projects? Consistent with these efforts, please provide 
examples of the type of guidance and technical assistance that the 
Department will issue to grantees receiving funding under CAPTA in 
order to meet these goals.
    Answer. An additional $16 million in funding will support 
demonstration projects in an initiative to shift and expand the focus 
of child welfare toward primary prevention of child maltreatment. The 
goal of the projects is to improve the safety and stability of all 
families by enhancing the capacity of communities to offer broad-based 
family supports; to use data to inform and align strategies across 
sectors to address site-specific barriers; and to support strategic 
collaborations with traditional family serving agencies and non- 
traditional partners (such as libraries, the business community, 
foundations, community colleges or vocational education providers, and 
philanthropies).
    Demonstration projects will provide services and resources for 
families that are voluntary; place-based and centrally located to 
ensure accessibility; coordinated with other public, faith-based, 
nonprofit, or private service providers that operate separate from 
government (but may receive funding from State or county sources); 
available universally and in non-stigmatizing ways; aimed at enhancing 
parental protective factors; and may include concrete supports such as 
limited financial, food, or housing assistance and/or legal and 
clinical services.
    Projects will implement, test, and evaluate the effectiveness of a 
multi-system approach to primary prevention, including strengthening 
family capacity and preventing child abuse and neglect before more 
formal intervention is necessary. The demonstration projects will be 
partnerships of public and private agencies, parents, community members 
with lived experiences, nonprofits, faith-based organizations, and 
others to implement effective community-based prevention approaches. 
Strategies and outcomes will be coordinated, monitored, and reported 
across multisector partners. A cross-site evaluation will be conducted 
and technical assistance on program implementation and local evaluation 
will be provided.
    Question. Research demonstrates that lesbian, gay, bisexual, 
transgender, and queer (LGBTQ) youth are overrepresented in the child 
welfare system, and that these youth are more likely to experience 
child abuse and neglect than their non-LGBTQ peers. What activities, 
technical assistance, and grant opportunities has the Department 
undertaken or considered to prevent child abuse and neglect 
specifically for lesbian, gay, bisexual, transgender, and queer youth?
    Answer. We are working to gain an understanding of the scope of 
LGBTQ representation in foster care by proposing to require Title IV-E 
agencies to report whether family conflict related to the child's 
expressed or perceived sexual orientation, gender identity, or gender 
expression was a circumstance at the child's removal. We proposed that 
Title IV-E agencies report this to the Adoption and Foster Care 
Analysis and Reporting System in the 2019 Notice of Proposed Rulemaking 
(84 FR 16595). The Unified Agenda estimates the final rule will be 
published in May 2020.
    Question. What steps is the Department taking to promote adoption 
permanency and improve outcomes for lesbian, gay, bisexual, 
transgender, and queer youth in the child welfare system, including 
under programs supported through the Adoption Opportunities Act?
    Answer. The Department has created a National QIC on Tailored 
Services, Placement Stability & Permanency for LGBTQ Children and 
Youth. The QIC is conducting 4-6 projects in public child welfare 
system sites to test a set of interventions that support the 
permanency, well-being, and stability of LGBTQ, as well as two-spirit, 
children and youth in the foster care system. The QIC will complete an 
evaluation of each of the project sites and a cross-site evaluation to 
produce evidence-informed or evidence-based models of engagement, 
services, and interventions that demonstrate improved well-being 
outcomes and provide permanency and placement stability for LGBTQ 
children and youth in foster care. The target population is children 
and youth in foster care who identify as LGBTQ within the service area 
of the selected State, county, or tribal child welfare systems.
    Expected outcomes for the QIC include:
  --Development and implementation of four to six research projects in 
        State, county, and tribal child welfare systems that commit to 
        building effective practice models to improve permanency, well-
        being, and placement stability outcomes for LGBTQ children and 
        youth in foster care;
  --Integration of identified practice models within the project site 
        system, including the policies, programs, and practices that 
        impact LGBTQ children and youth in foster care;
  --Promising practices and evidence-informed/evidence-based models of 
        engagement, appropriate collective and individual services and 
        intervention that can be linked to improved outcomes for the 
        target population;
  --Improved permanency, well-being, and placement stability outcomes 
        for LGBTQ children and youth in foster care in selected project 
        sites;
  --Through comprehensive, project-specific evaluation activities, 
        development of a catalogue of LGBTQ-responsive strategies and 
        practices to lay the groundwork for further development of 
        evidence-informed/evidence-based models of intervention for 
        LGBTQ children and youth in foster care, with supporting 
        protocols, tools and products that child welfare systems 
        seeking to implement improved LGBTQ services can look to for 
        guidance, insight, and replication; and
  --A cross-site evaluation that will build a body of knowledge 
        regarding the appropriate elements to consider and address when 
        building and implementing a comprehensive model of effective 
        engagement, services, and interventions for LGBTQ children and 
        youth in care.
    Question. It is vital to support Indian Tribes in strengthening 
families to prevent child abuse and neglect in Indian Country. Please 
provide a list of resources and activities developed or supported by 
the Department to address complex issues like child abuse and neglect 
prevention in Indian Country, and a description of the outreach 
conducted by the Department to make Indian Tribes and Tribal 
Organizations aware of such resources and activities. What efforts has 
the Department undertaken to identify, develop, or support culturally-
based child abuse and neglect prevention programs and activities?
    Answer. The Children's Bureau recognizes the vital need to provide 
support to Indian Country to strengthen families to prevent child abuse 
and neglect. The Children's Bureau provides this support in several 
different ways, including:
Community-Based Grants for the Prevention of Child Abuse and Neglect 
        Tribal and Migrant Programs
    The Children's Bureau oversees the award and implementation of 
Community-Based Grants for the Prevention of Child Abuse and Neglect 
Tribal and Migrant Programs. The purpose of this grant is to provide 
financial support to selected tribes, tribal organizations, and migrant 
programs for child abuse prevention programs and activities that are 
consistent with the goals outlined by Title II of the Child Abuse 
Prevention and Treatment Act. This legislation specifies that 1 percent 
of the available funding from Title II will be reserved to fund tribes, 
tribal organizations and Head Start migrant programs.
    The goal of the programs and activities supported by these funds is 
to prevent child abuse and neglect within tribal and migrant 
populations. The funds must support more effective and comprehensive 
child abuse prevention activities and family support services that will 
enhance the lives and ensure the safety and well-being of migrant and 
Native American children and their families. Grants were awarded in 
September 2016 for a 5-year grant period. The current grantees are: 
Child Abuse Prevention Services, Inc. (IA); Yakima Valley Farm Workers 
Clinic (WA); and Kickapoo Tribe in Kansas (KS).
National Quality Improvement Center (QIC) for Preventive Services and 
        Interventions in Indian Country
    The Center for Native Child and Family Resilience (Center), 
originally named the ``National Quality Improvement Center (QIC) for 
Preventive Services and Interventions in Indian Country,'' is a 
Children's Bureau 5-year cooperative agreement awarded to JBS 
International, Inc. in August 2017.
    The Center provides support to enhance resilience-related 
approaches to Tribal child welfare by developing evidence-based 
standards for programs aimed at the prevention and intervention of 
child abuse and neglect in American Indian/Alaska Native communities. 
The Center promotes awareness and use of culturally relevant child 
welfare programs grounded in community-based evaluation to demonstrate 
the effectiveness of these efforts, designed to improve holistic 
services for children and families who have experienced or are at risk 
of child abuse or neglect.
    The Center team works to gather, generate, and disseminate 
knowledge and information regarding effective practice models for 
strengths-based, culturally relevant, and trauma- informed preventive 
services and interventions for child maltreatment, supporting the 
transfer of knowledge from the Center projects to the field.
                                 ______
                                 
            Questions Submitted by Senator Richard J. Durbin
                         dtc price transparency
    Question. Secretary Azar, your budget request includes a $135 
billion ``allowance'' for savings from drug pricing legislation-
essentially a placeholder for what Congress is working to pass. As you 
know, I've been working for years on a simple measure to require 
pharmaceutical companies to put a price tag in their direct-to-consumer 
ads. The fiscal year 2019 Labor-HHS bill passed the Senate with an 
amendment from Senator Grassley and me to require this disclosure.
    When drug companies spend $6 billion to flood the air with ads that 
steer patients to the most expensive medications-more than the entire 
budget of the FDA by the way-I believe patients deserve to know how 
much the drug costs. We know the result otherwise, the 20 most- 
advertised drugs on television cost Medicare and Medicaid a combined 
$34 billion in 2018.
    Do you support including DTC language-similar to the Durbin-
Grassley language in the fiscal year 2019 Senate Labor-H bill-in the 
fiscal year 2021 Labor-HHS bill, or any other related larger package 
moving in the Senate?
    Answer. Since the Administration issued American Patients First, 
its blueprint to lower drugprices and out-of-pocket costs, FDA has 
promoted competition in drugs and biologics, advanced a strong 
framework for biosimilars, and modernized regulatory oversight of 
generic drugs. FDA does not set drug prices, but can help lower prices 
by bringing efficiencies to the drug development and review process and 
by promoting robust competition for established drugs. FDA-approved 
generic drugs now account for 90 percent of the prescriptions dispensed 
in the United States, and in 2018 competition from generic drugs saved 
the healthcare system an estimated $293 billion.
                            rural hospitals
    Question. Secretary Azar, the fiscal year 2021 budget request 
proposes to allow Critical Access Hospitals to voluntarily convert to 
an emergency outpatient clinic paid at the OPPS rate plus an add-on 
payment for capital costs, I think it is an idea that merits some 
consideration.
    But I am concerned that we may be several years away from 
developing that new payment and delivery model, yet we have a crisis 
right now with rural hospital closures. Illinois has thankfully been 
mostly spared, in part because we expanded Medicaid under the 
Affordable Care Act, but nationwide we have seen 120 rural hospitals 
close in the past decade. Last year was the worst year yet for this 
grim trend. A new report in February from the Chartis Center for Rural 
Health found that one in four rural hospitals are at risk of closure.
    Once a hospital closes, doctors leave, jobs disappear, businesses 
struggle, and families pull up roots. Senator Lankford and I have a 
bill to provide immediate relief by allowing a narrow set of 
vulnerable, rural hospitals to obtain Critical Access payment status, 
which is a model that works well for 57 hospitals already in my State.
    Do you support the intent of our effort (S.3103) to provide an 
immediate lifeline through a proven model for a universe of certain 
rural hospitals that need relief now and cannot afford to wait around 
to test new approaches to rural health delivery?
    Answer. 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 Healthcare.
    The Budget supports rural communities through programs such as the 
Rural Communities Opioids Response and the Telehealth Network Grant 
Program at HRSA, which supports substance use prevention, treatment, 
and recovery support services in high-risk rural communities, and 
promotes telehealth technologies for healthcare delivery. 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.
                   child trauma--update on task force
    Question. Last year's appropriations bill included $50 million in 
historic new funding for the NIH and CDC to conduct gun violence 
research. The Labor-HHS bill also dedicated nearly $4 billion for 
opioid treatment and response efforts. These are important investments, 
I commend the Chair and Ranking Member for their leadership. I believe 
prevention is an essential part of addressing these, and other, 
societal and health challenges.
    Experiencing serious traumatic events-such as witnessing violence 
or a parent's drug abuse--can have profound effects on a young person . 
. . creating stress that can harm brain and behavioral development. 
Decades of research, including the Centers for Disease Control and 
Prevention's Adverse Childhood Experiences (ACEs) study, have 
established the link between a child's exposure to trauma, its effect 
on neurological and behavioral development, and long-term negative 
outcomes. Exposure to trauma contributes to many of the societal 
challenges we face today, including the opioid crisis, chronic disease 
development, mental illness, violence, unemployment, and the academic 
achievement gap. If you've had four Adverse Childhood Experiences 
(ACEs) you are up to 10 times more likely to use heroin and 12 times 
more likely to attempt suicide.
    Scores of Federal grant programs provide services to children and 
families in each of these settings. Child- and family-serving 
professionals should have the tools and resources to prevent and 
mitigate the impact of trauma and ACEs. At the same time, our Federal 
Government needs an over-arching strategy to place the impact of trauma 
at the center of programmatic efforts-it will help to fulfill the 
missions of each member agency while mitigating costly, negative long-
term outcomes.
    In 2018, Senator Capito and I passed legislation as part of the 
SUPPORT Act to better train teachers, doctors, and social service 
providers to identify and support young people who have experienced 
trauma. One provision (Sec. 7132) created a task force of 26 Federal 
agencies to bring this understanding of trauma to every Federal grant 
program . . . including Head Start, Home Visiting, education, health, 
social services. The intent of Section 7132 is to bring the expertise, 
reach, and resources of the Federal Government to bear to enhance 
coordination, identify trauma-informed best practices, and promote 
models to prevent, screen, appropriately refer, and implement 
supportive interventions for children and their families who have 
experienced trauma.
    We believe this Trauma Task Force can transform the way that our 
Federal agencies address gun violence, addiction, mental illness, 
poverty, and many other challenges.
    So I was disappointed to see that your budget did not mention this 
effort-despite clear support from this Subcommittee in each of the past 
three Labor-HHS bills. Secretary Azar, can you provide an update on the 
activities of the Interagency Task Force on Trauma-Informed Care to 
date? Can you commit to implementing this Task Force in accordance with 
the statute's direction on timing and engagement with public 
stakeholders, letting us know if there is funding you need, and keeping 
our offices better informed on your progress?
    Answer. SAMHSA created an interagency Task Force to make 
recommendations regarding best practices to identify, prevent, and 
mitigate the effects of trauma on infants, children, youth, and their 
families, and to better coordinate the Federal response to families 
impacted by substance use disorders and other forms of trauma. The Task 
Force is required to develop a set of best practices regarding 
prevention strategies, identification of trauma, community-based 
practices, and State and local-level partnerships to support children 
and their families. Calls for a national strategy have been conducted 
on how Federal agencies can implement a coordinated response by 
coordinating existing Federal authorities and grant programs where 
trauma-informed practices have been implemented. SAMHSA is committed to 
implementing the Interagency Trauma Task Force as specified in 
legislation. The Task Force is developing the operating plan and will 
submit it by the deadline specified in the legislation (October 2020). 
Interagency Task Force in-person meetings were held on May 31, 2019, 
July 12, 2019, and February 3, 2020. Future in-person meetings are 
scheduled for May 1, 2020, August 14, 2020, and November 2, 2020. 
Monthly telephone calls are scheduled to fill in the gap months between 
in-person meetings. The Task Force is also committed to engaging public 
stakeholders and are identifying the best measures to take to achieve 
this effort. Moving forward, SAMHSA will continue to implement this 
Task Force in accordance with the statute's direction and will keep 
Congress informed on its progress.
                                 ______
                                 
                Questions Submitted by Senator Jack Reed
    Question. I am extremely disappointed that this Administration has 
continued to propose eliminating the Low Income Home Energy Assistance 
Program (LIHEAP), which helps low-income households and seniors with 
their energy bills. The number of households eligible for LIHEAP 
already exceeds the program's capacity, and for many who do receive 
energy assistance, the purchasing power of the grant has decreased over 
the past several years. These cuts have consistently been rejected by 
Congress and the program enjoys bipartisan support, including from 
members of this Committee. As such, I am deeply concerned that, 
although Congress increased LIHEAP funding by $50 million in fiscal 
year 2020 to help meet the needs of more Americans, the Department of 
Health and Human Services announced its intention to reprogram $37 
million from this account for coronavirus response. Diverting LIHEAP 
dollars that people depend on in the middle of winter is not the right 
approach. There are better ways to dedicate the necessary resources to 
protect Americans from the coronavirus threat. Do I have your 
commitment that you will not reprogram any LIHEAP funds in fiscal year 
2020 and will instead distribute them immediately to States so that 
they can be used for their intended purpose?
    Answer. Yes, funds originally transferred from LIHEAP for COVID-19 
response were returned to LIHEAP and released to States per the 
requirements of the Coronavirus Preparedness and Response Supplemental 
Appropriations Act, 2020 (Public Law 116-123).
    Question. Can you comment on your Department's proposed cuts to 
critical global health and public health programs and explain how those 
cuts will prepare us against new and emerging outbreaks like 
Coronavirus and Zika? We have all learned over the last several years 
that new disease outbreaks are not isolated incidents. Public health 
funding is an investment that needs to be made over the long term to 
build our public health infrastructure. In particular, can you explain 
the $7 million cut to NIH's Fogarty International Center, which helps 
train public health officials worldwide, build relationships between 
our public health officials and those in other countries, and stand up 
public health efforts internationally?
    Answer. The Fogarty International Center (FIC) plays an important 
role in global health research by strengthening the scientific 
workforce in the United States and abroad to address existing and 
future health threats that affect us all. To date, FIC grants have 
resulted in a cadre of over 6,000 trainee alumni throughout the world. 
Fogarty trains scientists for global health research, fosters 
international research networks, and strengthens the research 
infrastructure abroad. Notably, these programs are built on long-
standing partnerships between U.S. and developing country institutions.
    FIC invests strategically in future leaders and institutions, both 
here in the U.S. and abroad. FIC will continue to build public health 
research capacity where health problems are most prevalent. For 
example, FIC-supported programs are training scientists on the ground 
in developing countries to study emerging infections, epidemics and 
pandemics at their point of origin, which will help to quickly contain 
outbreaks and prevent or limit the spread of communicable diseases to 
the United States and globally. In addition, Fogarty's in-house 
research unit uses data-driven modeling and computational tools to 
improve the study of the spread of disease and inform policy. This team 
is currently focused on the urgent need to study the epidemiology and 
transmission dynamics of Coronavirus (COVID-19) in China. Plans are 
underway to model the impact of interventions like social/physical 
distancing and isolation.
    Question. Like many of my colleagues, I am deeply disturbed by the 
proposed cuts to Medicaid in the President's fiscal year 2021 budget 
request. This budget proposes cutting nearly $1 trillion from Medicaid. 
What's worse, this budget request provides no details for who these 
cuts would target. A cut of this magnitude would end Medicaid as we 
know it and deny access to care for millions of Americans, including 
our most vulnerable citizens. Can you provide estimates for how many 
seniors, children, and people with disabilities you expect to lose 
coverage because of this cut?
    Answer. HHS's proposed budget slows the average annual growth of 
Medicaid from 5.4 percent to 3.1 percent, never spending less than in 
fiscal year 2020. 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. Medicaid's open-ended 
financing structure and recent growth have made it the number 1 or 2 
budget item for most States, consuming an average of 30 percent of 
total State budgets; budget reforms ensure the program remains a safety 
net for generations to come. CMS does not have estimates regarding 
change in coverage due to these reforms; the intent of these reforms is 
not to reduce coverage, but rather to make the program fiscally 
sustainable and therefore available for generations to come.
    Question. As you know, the Childhood Cancer Survivorship, 
Treatment, Access, and Research (STAR) Act, which I authored and worked 
on a bipartisan basis to pass in 2019, included a number of provisions 
to help advance our understanding of the needs of survivors of 
childhood cancer and to improve treatment and quality of life for these 
childhood cancer survivors. In particular, Section 201(b) of this law 
requires HHS to conduct a review of Federal workforce development 
efforts for healthcare professionals who treat pediatric cancer 
patients and survivors and report to Congress by June 5, 2020. I look 
forward to reviewing the report later this year. In addition, Section 
201(a) authorizes pilot programs to explore model systems of care for 
pediatric cancer survivors. Can you provide an update on implementation 
of Section 201(a) and in particular, how much funding will be required 
to bring this effort to fruition?
    Answer. Progress is being made on the implementation of the 
Childhood Cancer STAR Act. Including the activities listed below, HHS 
is currently assessing how to fully implement Section 201. Activities 
being carried out by NIH and AHRQ include:
  --Section 101: Children's cancer biorepositories and biospecimen 
        research. NCI convened a meeting in May 2019 of more than 60 
        extramural researchers and advocates, along with NCI scientific 
        staff, to discuss challenges and opportunities to enhance 
        biobanking for childhood cancers. Informed by this discussion, 
        in fiscal year 2019 NCI provided a grant supplement award to 
        Nationwide Children's Hospital to support immediate 
        enhancements to the Children's Oncology Group Biorepository. 
        NCI scientific leadership has identified additional 
        opportunities to enhance and expand childhood cancer 
        biospecimen collection and biobanking resources in fiscal year 
        2020 and will soon be moving forward to solicit applications.
  --Section 111: Inclusion of at least one pediatric oncologist on the 
        National Cancer Advisory Board. There are currently two 
        pediatric oncologists appointed to the National Cancer Advisory 
        Board (NCAB). Dr. Peter Adamson of the Children's Hospital of 
        Philadelphia was appointed to NCAB in 2015 and his term 
        concludes in 2020. In October 2019, President Trump announced 
        the appointment of Dr. Andrea Hayes-Jordan, Surgeon-in-Chief at 
        the University of North Carolina Children's Hospital. Dr. 
        Hayes-Jordan's appointment is pending final approval, and her 
        NCAB term is expected to conclude in 2024.
  --Section 112: Sense of Congress regarding pediatric expertise at the 
        National Cancer Institute. In addition to pediatric oncology 
        expertise on NCAB, other NCI advisory boards, groups, and 
        committees continue to include pediatric oncologists, 
        scientists with pediatric expertise, and patient advocates. 
        This includes more than 40 subject matter experts with 
        pediatric expertise across three relevant NCI National Clinical 
        Trials Network Steering Committees, with a patient advocate 
        serving on each committee.
  --Section 121: Reporting on childhood cancer research projects. NCI 
        and NIH reporting on childhood cancer research projects will 
        continue to include the annual NIH Pediatric Research 
        Initiative Report to Congress, as well as the NIH Triennial 
        Report. After the close of each fiscal year, NIH also makes 
        estimates of funding for various Research, Condition, and 
        Disease Categories (RCDC) available on its website, including a 
        ``Pediatric Cancer'' category, which links through to a list of 
        hundreds of research projects supported by several NIH 
        Institutes and Centers. NCI also reports on activities across 
        its childhood and adolescent and young adult (AYA) cancer 
        research portfolio on its website through several pages focused 
        on childhood and AYA cancer research and resources for patients 
        and families.
  --Section 201: Section 201 directs HHS to conduct a review of Federal 
        workforce development efforts for healthcare professionals. 
        AHRQ is currently assessing how they could fully implement 
        Section 201. This includes assessing resources that would be 
        needed to implement the pilot programs and dedicate staff with 
        expertise in pediatric cancer and management of cancer 
        survivors. These pilots would be informed by ongoing AHRQ work 
        to conduct three separate evidence reviews focusing on the 
        transition of care from pediatric to adult services for 
        childhood and adolescent cancer survivors; models of pediatric 
        survivorship care; and disparities and barriers to survivorship 
        care and strategies that have been proposed to address these 
        barriers (Section 203). Section 201(b) of this law requires a 
        review of Federal workforce development efforts for healthcare 
        professionals.
  --Section 202: Grants to improve care for pediatric cancer survivors. 
        NCI continues to conduct and support critical ongoing childhood 
        and AYA survivorship research efforts, including NCI's long-
        standing investment in the Childhood Cancer Survivor Study. In 
        fiscal year 2019 NCI also supported several new childhood and 
        AYA survivorship research projects, including three new 
        projects funded through a request for applications (RFA) 
        developed to align with Section 202 of the STAR Act. The second 
        receipt date for this RFA was in January 2020. Peer review is 
        currently underway for this second round of applications, and 
        NCI expects to make several awards in fiscal year 2020. 
        Additionally, in December 2019, NCI's Board of Scientific 
        Advisors approved a new RFA aligned with Section 202 of the 
        STAR Act. This RFA is expected to post to the NIH Guide for 
        Grants and Contracts later this year, with application receipt 
        dates scheduled for 2021 and 2022.
                                 ______
                                 
             Questions Submitted by Senator Jeanne Shaheen
                         medicaid block grants
    Question. The Department recently proposed guidance to States that 
would allow States to waive Medicaid rules and convert their Medicaid 
expansion programs into a block grant that does not keep pace with the 
cost of providing care. If New Hampshire were to take up such a block 
grant, it could be devastating to our effort to combat the substance 
misuse epidemic through Medicaid expansion. The State would likely need 
to limit benefits, impose new costs on patients or cut payments to 
providers in order to keep within the block grant allotment.
    At a time when New Hampshire and so many other States that are 
hard-hit by the opioid epidemic are using the Medicaid expansion to get 
people the treatment they need, why is the Department of Health and 
Human Services (HHS) proposing block grants that would erode the 
Medicaid expansion?
    Answer. 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 permissible 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. It 
provides rigorous protections for all Medicaid beneficiaries, and for 
the first time it aligns financial incentives to improve quality of 
care and health outcomes for Medicaid adults by giving States 
unprecedented flexibility to administer and design their programs to 
meet this population's unique needs. In exchange for this flexibility, 
States accept greater accountability for managing the program and 
demonstrating real results. States have a long history of managing 
budgets. Every State has already accepted the risk of capped Federal 
funding, through either their CHIP program or an 1115 waiver.
    Question. As a part of questions for the record following Secretary 
Azar's appearance before the Subcommittee on April 4, 2019, I asked 
questions regarding Medicaid block grants, including a request for an 
explanation of the ``statutory authority you rely on to make such a 
change.'' At that time, you did not answer the statutory authority 
question and instead noted that ``this topic is still under 
development.'' Now that a proposal has been issued, I ask again: what 
statutory authority do you rely on to make this change?
    Answer. The Healthy Adult Opportunity (HAO) would use section 1115 
waiver and expenditure authority to allow States' proposed HAO 
demonstrations to go into effect.
    Under the demonstration authority granted by section 1115(a) of the 
Act, in the case of a demonstration that CMS determines is likely to 
assist in promoting the objectives of the Medicaid program, CMS can 
waive under section 1115(a)(1) of the Act, or not apply under section 
1115(a)(2) of the Act, many Federal requirements so that States can 
test new or existing ways to deliver and pay for healthcare services 
under the Medicaid program. CMS can provide expenditure authority under 
section 1115(a)(2) of the Act to allow States to provide coverage to 
individuals not eligible under the State plan, which can offer 
significantly more flexibility without the need for individual section 
1115 waivers. The HAO initiative will involve the use of section 
1115(a)(2) authority to provide coverage to individuals not eligible 
for benefits under the State plan, while affording States maximum 
flexibility in the administration of benefits for such individuals.
                  medicaid fiscal accountability rule
    Question. Healthcare providers across New Hampshire have expressed 
concerns to me that if finalized, your administration's ``Medicaid 
Fiscal Accountability Rule'' (MFAR), could severely curtail access to 
care in New Hampshire. The rule is expected to significantly alter 
hospital supplemental payments and cripple State Medicaid program 
financing. New Hampshire healthcare providers are concerned that rather 
than simply clarifying current policies regarding providers' roles in 
funding the non-Federal share of Medicaid, the rule would introduce 
vague standards that are unenforceable and inconsistent with the 
statutory authority of the Centers for Medicare and Medicaid Services 
(CMS).
    A recent study by Manatt Health analyzed the potential financial 
impact of the proposed rule and found that, nationally, the Medicaid 
program could face total funding reductions between $37 billion and $49 
billion annually, or 5.8 percent to 7.6 percent of total program 
spending. Hospitals specifically could see reductions in Medicaid 
payments of $23 billion to $31 billion annually, representing 12.8 
percent to 16.9 percent of total hospital program payments.
    For New Hampshire and other rural States, access to care is already 
in jeopardy. New Hampshire healthcare providers are concerned that this 
rule could compound those access issues.
    How do you plan to protect beneficiaries' access to care should 
this proposed rule be finalized? If a Medicaid beneficiary loses access 
to their providers or their coverage as a result of this rule, how will 
CMS ensure that the beneficiary's access to care is restored?
    Answer. CMS believes it is important to ensure a process for public 
notice and comment that provides for a meaningful level of public 
input, including input regarding the impact of the proposed rule on 
Medicaid beneficiary access to care. As you know, the proposed rule 
(CMS-2393-P) was issued on November 12, 2019 and published in the 
November 18, 2019 issue of the Federal Register, with a 60-day comment 
period that closed on January 17, 2020. The comment period, which was 
subsequently extended by fifteen days, and ultimately closed on 
February 1, 2020. We will take into consideration all relevant comments 
that were received during the extended public comment period.
    While we review the comments we received, I want to assure you that 
we are 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 comparable to those generally 
available. 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.
    We note that the proposed rule does not eliminate States' ability 
to make supplemental payments to inpatient and outpatient facilities 
under the Medicaid State plan. It also does not propose to prevent 
States from targeting necessary payments to important safety net 
providers. As such, we do not anticipate the proposed rule, once 
finalized, will impact beneficiary access to care.
    Question. Has your Department analyzed how beneficiaries would be 
affected by this rule given it will take billions of dollars out of the 
program? If not, how can CMS proceed with this major rule affecting how 
states finance their Medicaid programs without conducting any analysis 
of the impact of the rule?
    Answer. Nothing in our proposed rule would stop States from using 
supplemental payments, provided that they are used and financed in a 
way that is in compliance with Federal statute and regulations. This 
proposed rule is not intended to reduce Medicaid payments, we believe 
these estimates of funding loss and lower beneficiary access are 
overblown.
    If States have arrangements that need to evolve to comply with any 
final rule, we would work with them to make that a successful 
transition. HHS has a responsibility to answer the calls from oversight 
bodies and address practices that have allowed States to avoid 
contributing their fair share to the program, effectively increasing 
the Federal contribution above what the law provides. Failure to do so 
would be deeply unfair to the Federal taxpayers and to States that have 
played by the rules, and provide them little reason to continue their 
sound practices.
    In regards to impact analysis of the rule CMS believes effects may 
be limited and are hard to quantify due to a number of reasons, 
including:
  --Many of the proposals reflect clarifications of existing policy, 
        not new legal requirements, and would not be expected to have a 
        significant impact on State financing arrangements apart from 
        changes that may be necessary for certain States to come into 
        compliance with current Federal requirements.
  --The potential decrease in Medicaid reimbursements for providers 
        receiving supplemental payments could be mitigated if States 
        take action to increase Medicaid provider base payments, which 
        would thereby increase the amount that could be paid out in 
        Medicaid supplemental payments.
  --CMS does not have sufficient data to predict or quantify the impact 
        of the proposed provisions on health-care related taxes.
  --CMS expects that States may modify existing State tax policy or 
        arrangements where those taxes or arrangements would be newly 
        considered healthcare related under the proposed provisions, 
        reducing the fiscal effect of the rule.
              position on medicare drug price negotiation
    Question. When President Trump was running for office in 2016, he 
frequently expressed support for allowing Medicare to negotiate 
prescription drug prices. This is a proposal that I have also long 
supported. As recently as September, the President tweeted out his 
support for the House bill that would allow Medicare to negotiate the 
price of medications and would reduce prices for many common 
prescriptions, like insulin, by 55 percent on average. Those savings 
would mean the world to Granite Staters like Bob Slavin from Franklin, 
New Hampshire, who says he is maxing out credit cards to pay for the 
skyrocketing cost of insulin. Yet, in December when it came time for a 
House vote on the drug price negotiation bill, President Trump said he 
would veto the bill.
    Why did the President change his mind and decide to oppose 
legislation to allow Medicare to directly negotiate the price of 
prescription drugs?
    Answer. President Trump has made it clear how important tougher 
negotiation is. That is exactly what our Administration has been doing 
for Medicare, in an effective and targeted fashion. We are working to 
make negotiation more effective than it is today in our prescription 
drug program, Part D, and to bring negotiation to where it doesn't 
exist, in physician administered drugs, Part B.
    While some believe Medicare could save tons of money by negotiating 
directly for drugs, this just isn't true. If the government were to 
directly negotiate we would have to create a single formulary. This 
would be a highly restrictive uniform formulary for every senior 
citizen in America. One approach to this problem could be to replace 
negotiation with a price setting mechanism. For example, by setting a 
penalty so high that there really is no opportunity to negotiate. 
However, price setting does not get us closer to negotiation, and it 
will reduce access and innovation over time.
    We can see in Medicare Part D that negotiation works. Pharmacy 
Benefit Managers (PBMs) play an important role negotiating lower prices 
for America's seniors, and offer them to beneficiaries through a number 
of private plans. Having such a robust landscape means people can vote 
with their feet and choose the plan with the formulary that best meets 
their needs. We just need to ensure that these lower prices are being 
passed on to patients.
                     affordable care act court case
    Question. The HHS budget proposal has an increased focus this year 
on reducing maternal mortality and improving maternal health. I agree 
that this is an area where we must do more to improve health outcomes 
for so many women. However, at the same time, the Trump Administration 
is backing a lawsuit in Federal court that would strike down the 
Affordable Care Act (ACA) in its entirety.
    If the courts strike down the ACA, insurance companies will be able 
to return to the days when they can deny coverage to women for pre-
existing conditions. Insurers will be able to eliminate maternity care 
coverage. Insurers will even be able to charge women higher premiums 
than men.
    How does the Department square this budget's purported support for 
improving maternal health with this administration's support for a 
lawsuit that would tear down the ACA and eliminate the health 
protections that pregnant women and new mothers rely upon?
    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.\6\
---------------------------------------------------------------------------
    \6\ 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.\7\
---------------------------------------------------------------------------
    \7\ 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.\8\
---------------------------------------------------------------------------
    \8\ 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, wellbeing, 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).\9\ 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 (Public Law 115-123), 
State reporting of the Child Core Set, including maternal and infant 
health measures, will become mandatory beginning in 2024.
---------------------------------------------------------------------------
    \9\ 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.\10\ 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.
---------------------------------------------------------------------------
    \10\ Available at: https://www.medicaid.gov/state-overviews/
scorecard/index.html.
---------------------------------------------------------------------------
    The Supreme Court will consider in its next term whether the 
Affordable Care Act's individual mandate is unconstitutional and, if 
so, the status of the remainder of the Act. Meanwhile, HHS will 
continue administering and enforcing all aspects of the ACA as it had 
before the Fifth Circuit issued its decision. The appellate court 
decision does not require HHS to make any changes to any of the ACA 
programs it administers or its enforcement of any portion of the ACA at 
this time. The Trump Administration has consistently supported 
preserving protections for all Americans with pre-existing conditions, 
including pregnant women and new mothers. The administration stands 
ready to work with Congress on policy solutions like those in our 
Budget and increase access to maternal health services.
             non-opioid alternatives to post-surgical pain
    Question. In recent rulemakings for Medicare payments under the 
Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical 
Center (ASC) payment system, the administration has agreed to examine 
its packaging policies and pay separately for non-opioid pain 
management treatments. However, CMS has made it clear that it will only 
change its packaging policies if it finds that its own payment systems 
(either the OPPS or ASC) present a barrier to the use of non- opioids. 
The Department is effectively suggesting that it will only take action 
if it finds that its own packaging policy has unintentionally 
contributed to the opioid crisis.
    In response to a recent letter I wrote to CMS, the agency indicated 
between 2013 and 2018, it had not observed significant declines in the 
total number of units used in hospital outpatient departments for drugs 
and related items deemed to be non-opioid alternatives. CMS noted that 
in some cases the agency observed increases in the number of units used 
in hospital outpatient departments for certain non-opioid alternative 
drugs during the 6-year period. CMS suggests that the lack of decrease 
in the number of units of non-opioid drugs that were used in hospital 
outpatient departments between 2013 and 2018 is proof that Medicare 
payment policies do not deter the use of non-opioid alternatives. 
However, to date, CMS responses have not compared the change in overall 
units of non-opioid drugs used in hospital outpatient departments with 
changes in the overall number of surgeries performed in hospital 
outpatient departments where non-opioid drugs could be used to treat 
post-surgical pain.
    Can you provide data to show the rate of change in units of non-
opioid drugs used in hospital outpatient departments compared to the 
growth in hospital outpatient surgeries for which non-opioid 
alternatives could be a candidate for treating post-surgical pain?
    Answer. As required under section 6082 of the SUPPORT Act, for 
purposes of the calendar year (CY) 2020 proposed rule for the Medicare 
hospital outpatient prospective payment system (OPPS) and ambulatory 
surgical center (ASC) payment system, CMS conducted an evaluation of 
its payment policies for opioids and evidence-based non-opioid 
alternatives under these systems. The goal of this analysis, as 
articulated by law, was to conduct a review of payments for opioids and 
evidence-based non-opioid alternatives for pain management ensure that 
there are not financial incentives to use opioids instead of non-opioid 
alternatives. We believed that if CMS packaging policies discouraged 
the use of these non- opioid alternatives or impeded access to these 
products, our analysis would show a decline in utilization of non-
opioid alternatives over time.
    In our evaluation, we looked at several packaged drugs and devices 
used in covered medical procedures to determine if the current 
packaging policy represented a barrier to access. For each product, the 
most recently available Medicare claims data as well as medical 
literature relating to use of these products being used as an 
alternative to opioids was examined. All of the alternatives examined 
showed consistent or increasing utilization in recent years, with no 
products showing decreases in utilization, suggesting that current 
payment policy does not present a barrier to access of these products.
    Drugs that function as surgical supplies were examined over a 6-
year time period (CYs 2013 through 2018). During our evaluation, we did 
not observe significant declines in the total number of units used in 
the hospital outpatient department for a majority of the drugs included 
in our analysis. In fact, under the OPPS, we observed the opposite 
effect for several drugs that function as surgical supplies. Similar to 
the findings associated with devices above, this trend indicated 
appropriate packaged payments that adequately reflect the cost of the 
drug and are not prohibiting beneficiary access.
    The results of this review and evaluation of medical literature and 
claims data did not support evidence to indicate that our packaging 
policies had the unintended consequence of discouraging the use of non-
opioid treatments for postsurgical pain management in the OPPS setting, 
including drugs that function as a surgical supply, nerve blocks, or 
neuromodulation products.
    To broaden our analysis, the CY 2020 OPPS/ASC proposed rule also 
sought public comment on other non-opioid treatments for acute pain 
that might be affected by OPPS and ASC packaging policies and warrant 
separate payment. However, the public comments and data that CMS 
received regarding specific products did not provide sufficient 
evidence-based support that the current packaged payment policies for 
these non-opioid alternatives presented a barrier to access to care and 
warranted revised, separate payment to reduce incentives. We provide 
further analysis of our review of these specific products in the CY 
2020 OPPS/ASC final rule (CMS-1717-FC) released on November 1, 2019.
    We did not specifically analyze the rate of change in each unit of 
packaged drugs and devices relative to the number of aggregate hospital 
surgeries each year. We note that there are many factors that are 
independent of payment policy, including the availability of other 
treatment options, the clinical needs and profile of patients, and 
provider decisions regarding drug formularies and device purchasing, 
that could influence those trends. Therefore we determined that the 
changes in actual utilization of items and services is the best 
available indicator of whether existing payment policies pose a barrier 
to access to those products.
    We will continue to analyze the issue of access to non-opioid 
alternatives in the OPPS and the ASC settings for any subsequent 
reviews we conduct under Section 6082 of the SUPPORT Act. We are 
continuing to examine whether there are other non-opioid pain 
management alternatives for which our payment policy should be revised 
to allow separate payment under the OPPS.
    Question. Given the severity of the Nation's crisis, is it now time 
for the Department to take a more active role in promoting the use of 
non-opioids, by paying separately for non-opioid therapies with an Food 
and Drug Administration (FDA)-approved indication for pain reduction?
    Answer. As required under section 6082 of the SUPPORT Act, for 
purposes of the calendar year (CY) 2020 proposed rule for the Medicare 
hospital outpatient prospective payment system (OPPS) and ambulatory 
surgical center (ASC) payment system, CMS conducted an evaluation of 
its payment policies for opioids and evidence-based non-opioid 
alternatives under these systems. The goal of this analysis was to 
determine whether our packaging policies reduced the use of non-opioid 
alternatives and incentivized the use of opioids. We believed that if 
CMS packaging policies discouraged the use of these non-opioid 
alternatives or impeded access to these products, our analysis would 
show a decline in utilization of non- opioid alternatives over time.
    In our evaluation, we looked at several devices used in covered 
medical procedures to determine if the current packaging policy 
represented a barrier to access. For each product, the most recently 
available Medicare claims data as well as medical literature relating 
to use of these products being used as an alternative to opioids was 
examined. All of the alternatives examined showed consistent or 
increasing utilization in recent years, with no products showing 
decreases in utilization, suggesting that current payment policy does 
not present a barrier to access of these products.
    Drugs that function as surgical supplies were examined over a 6-
year time period (CYs 2013 through 2018). During our evaluation, we did 
not observe significant declines in the total number of units used in 
the hospital outpatient department for a majority of the drugs included 
in our analysis. In fact, under the OPPS, we observed the opposite 
effect for several drugs that function as surgical supplies. Similar to 
the findings associated with devices above, this trend indicated 
appropriate packaged payments that adequately reflect the cost of the 
drug and are not prohibiting beneficiary access.
    The results of this review and evaluation of medical literature and 
claims data did not support evidence to indicate that our packaging 
policies had the unintended consequence of discouraging the use of non-
opioid treatments for postsurgical pain management in the OPPS setting, 
including drugs that function as a surgical supply, nerve blocks, or 
neuromodulation products.
    To broaden our analysis, the CY 2020 OPPS/ASC proposed rule also 
sought public comment on other non-opioid treatments for acute pain 
that might be affected by OPPS and ASC packaging policies and warrant 
separate payment. However, the public comments and data that CMS 
received regarding specific products did not provide sufficient 
evidence-based support that the current packaged payment policies for 
these non-opioid alternatives presented a barrier to access to care and 
warranted revised, separate payment to reduce incentives. We provide 
further analysis of our review of these specific products in the CY 
2020 OPPS/ASC final rule (CMS-1717-FC) released on November 1, 2019.
    We will continue to analyze the issue of access to non-opioid 
alternatives in the OPPS and the ASC settings for any subsequent 
reviews we conduct under Section 6082 of the SUPPORT Act. We are 
continuing to examine whether there are other non-opioid pain 
management alternatives for which our payment policy should be revised 
to allow separate payment under the OPPS.
                       medicaid work requirements
    Question. Earlier this month a three-judge panel of the U.S. Court 
of Appeals for the District of Columbia unanimously struck down 
Medicaid work requirements in Arkansas. New Hampshire was headed for a 
similar outcome until the State delayed implementation of its program 
and after a Federal District Court blocked implementation of New 
Hampshire's ``work requirement'' program. As you likely also know, 
every lawsuit challenging CMS's approval of Medicaid work requirements 
has succeeded.
    Given that the courts keep rejecting Medicaid work requirements, 
why are you still promoting this illegal, expensive, and 
administratively burdensome initiative?
    Answer. The Department of Health and Human Services (HHS) supports 
States' efforts determine how to manage their Medicaids program, 
including the ability to test community engagement requirements. HHS is 
evaluating its options in seeking further review by the courts; no 
final decision has been made at this time. This Administration is 
committed to considering proposals that would give States more 
flexibility to engage with their working-age, able-bodied citizens 
through demonstrations that will help them rise out of poverty to 
create a better life for themselves and their families.
    Question. Does HHS plan to appeal the recent decision from the U.S. 
Court of Appeals for the District of Columbia to the United States 
Supreme Court?
    Answer. HHS is evaluating its options in seeking further review; no 
final decision has been made at this time.
                                 ______
                                 
              Questions Submitted by Senator Jeff Merkley
                fiscal year 2021 budget request for orr
    Question. Secretary Azar, the fiscal year 2021 Department of Health 
and Human Services (HHS) budget request notes an increase in funds for 
the Office of Refugee Resettlement. President Trump has cut the refugee 
admission ceiling to its lowest recorded level since the Refugee Act of 
1980. We are welcoming just 18,000 people for fiscal year 2020. This is 
less than 10 percent of how many new community members we were settling 
during the 1980 high water mark of over 207,000 new community members 
that came to America.
    At a time when over 70 million people around the world are 
displaced from their homes, do you feel that the United States is doing 
everything it can to show leadership and commitment to our ideals of 
freedom and peace by cutting off refugee admissions at just 18,000 
during this humanitarian crisis?
    Answer. The U.S. Department of State (DOS) is charged with 
overseeing the refugee admissions process. The DOS Report to Congress 
on Proposed Refugee Admissions for fiscal year 2020 states that the 
``...refugee admissions ceiling reflects the urgent need to address the 
border security and humanitarian crisis caused by the massive surge of 
aliens seeking protection at the U.S. southern border. It also reflects 
the backlog of nearly one million asylum-seekers who are awaiting 
adjudication of their claims inside the United States.''
    Question. When the President's refugee ceiling is set at 18,000--
why does the HHS fiscal year 2021 assumption state an estimated 91,000 
new arrivals?
    Answer. ORR is charged to serve the following eligible populations: 
refugees, asylees, victims of human trafficking, Special Immigrant Visa 
holders (SIVs), and Cuban/Haitian entrants. The HHS fiscal year 2021 
assumption estimates approximately 91,000 arrivals broken down in the 
following categories, including dependent family members:
  --18,000 refugees
  --45,600 asylees
  --920 victims of human trafficking
  --10,000 SIVs
  --16,000 Cuban/Haitian entrants
    Question. The number of unaccompanied children in your care has 
stabilized at a substantially lower number than last year. In February 
2019, you reported that you had an average of 11,473 children in your 
care. The most recent numbers released for this year show you have an 
average of 4,236 kids in your custody.
    Why does the HHS refugee resettlement budget requests a $680 
million increase in funding for unaccompanied children?
    Answer. Given the historic fluctuation in the number of children 
requiring shelter, there is no guarantee that the number of children in 
care has stabilized. The budget request reflects the level of funding 
we estimate will be necessary to support a capacity of 16,000 State-
licensed permanent beds, depending on operational need, as well as the 
periodic activation of temporary influx beds if they are needed.
    Question. Is this increase in funding going to be used to 
prioritize State-licensed not-for-profit care facilities, Flores 
protections, and quality legal services for kids?
    Answer. This funding will support care, compliance with the 
standards set forth in the Flores Settlement Agreement, and services 
for UAC, including legal services as well as home study, child 
advocate, and post-release case management. Both not-for-profit and 
for-profit youth care organizations are eligible to apply for grants to 
shelter UAC and provide transitional foster care and long term foster 
care services. ORR advertises these grants openly through Funding 
Opportunity Announcements.
                flores settlement agreement protections
    Question. On May 22, 2019, your team informed State-licensed 
facilities for refugee children that HHS would not pay for recreation 
or education, despite the fact that the 1997 Flores Settlement 
Agreement mandates these care standards. This is an apparent violation 
of Flores.
    Why does HHS believe that children in your care should not be 
provided education or recreation--a chance to go play soccer, or learn 
how to read and write?
    Answer. ORR complies with all minimum standards as set forth in the 
Flores Settlement Agreement. ORR provides educational services 
appropriate to the unaccompanied alien child's level of development and 
communication skills in a structured classroom setting Monday-Friday, 
which concentrates primarily on the development of basic academic 
competencies and secondarily on English Language Training. Basic 
academic areas of study include Science, Social Studies, Math, Reading, 
Writing and Physical Education. Educational services must provide 
children with appropriate reading materials in languages other than 
English for use during leisure time.
    In addition, care provider programs must provide daily outdoor 
activity, weather permitting, with at least one hour per day of large 
muscle activity and one hour per day of structured leisure time 
activities (that should not include time spent watching television). 
Activities should be increased to a total of three hours on days when 
school is not in session.
    For complete information on the minimum required services, please 
see 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).
    Question. Was this directive to cease recreation or education 
funding implemented?
    Answer. At the time, ORR entered deficiency status under the Anti-
Deficiency Act (ADA), which limited ORR's ability to make obligations 
for any activities that did not directly support life, health, and 
safety under the exception to the ADA. UAC education and recreation 
services did not qualify for the exception to the ADA.
    For grants awarded on or after May 22, 2019, ORR included a 
provision on the Notice of Grant Award that stated:
    ``RESTRICTION ON RELEASE OF FEDERAL FUNDS

    The Unaccompanied Children Program is currently operating under a 
        deficiency apportionment, as outlined in 31 U.S.C 1515. As a 
        result, all costs budgeted for recreational or educational 
        activities, including personnel associated with these 
        activities, are hereby restricted from drawdown. This 
        restriction applies only to funds awarded to grant 90ZU0208 on 
        or after May 22, 2019 and will remain in effect until further 
        notice from the awarding agency.''

    On June 14, ORR issued additional information to care providers. 
State-licensed or federally- contracted facilities for the care of 
children could use any previously obligated funds for these services.
    Finally, on June 28, ORR issued Notice of Grant Award to lift this 
restriction on all grantees with passage of the supplemental 
appropriations.
    Question. Does the Office of Refugee Resettlement currently provide 
all kids in your care the Flores-protected right to education and 
healthy physical activity?
    Answer. Yes. ORR provides all Flores mandated services in 
compliance with the terms of the FSA and ORR policy.
    Question. Your recent proposed regulatory changes undermine the 
protections for kids that Flores established. Can we agree that the 
Flores protections are not optional, are necessary to uphold, and that 
regardless of where we come from or the color of our skin, all kids 
deserve a good childhood?
    Answer. The HHS provisions of the Flores Final Rule are consistent 
with mandatory service and placement requirements for UAC under the 
FSA, read together with subsequently enacted laws.
    Question. Your recent proposed regulatory changes include numerous 
instances where the mandatory protections in the Flores Settlement are 
replaced with discretionary language. For example, while Settlement 
para.11 states that the government ``shall place each detained minor in 
the least restrictive setting,'' the regulation states that the 
government ``places each UAC in the least restrictive setting.'' 45 
C.F.R. Sec. 410.201(a).
    Please explain how removing these protections is consistent with 
the government's obligations under the Flores Settlement.
    Answer. The provisions are read as mandatory. Under the regulation, 
the government is required to place children in the least restrictive 
setting.
    Question. Please explain why you think removing these mandatory 
protections helps to protect children's health, safety, and welfare.
    Answer. The provision does not remove mandatory protections, the 
language is not discretionary. In provisions that require the 
government to provide services or benefits to UAC, the regulatory text 
uses the words ''will,'' ''shall,'' and ''must.'' For example, in 
Sec. 410.402 that replicates the requirements of Exhibit 1 of the FSA, 
it clearly states that ``Licensed programs must. . .'' and then lists 
all required services. On the other hand, when it could benefit the UAC 
that the government not act in a strict manner, the regulatory text 
uses ''may.'' (See HHS response to comments related to 45 CFR 201 
available at: https://www.Federalregister.gov/documents/2019/08/23/
2019-17927/apprehension-processing-care-and-custody-of-alien-minors-
and-unaccompanied-alien-children).
    Question. Your recent proposed regulatory changes undermine the 
bond hearing protections for children established in Flores Settlement 
para.24A guarantees class members a ``hearing before an immigration 
judge in every case, unless the minor indicates on the Notice of 
Custody Determination form that he or she refuses such a hearing.'' The 
regulations replace immigration judges with HHS employees and requires 
children to affirmatively request a bond hearing. 45 C.F.R. 
Sec. 410.810.
    Please explain how replacing immigration judges with HHS employees 
is consistent with the Flores Settlement.
    Answer. HHS is responsible for the care and custody, as well as 
placement decisions for all unaccompanied alien children. Properly 
trained HHS personnel (who are neutral arbitrators, such as Federal 
career Administrative Law Judges or hearing officers with HHS' 
Departmental Appeals Board) would be able to provide more child 
friendly, trauma-informed hearings, designed by child welfare experts, 
while maintaining independence from ORR.
    Also, the Flores Settlement was entered into by the former 
Immigration and Naturalization Service (INS), within the Department of 
Justice (DOJ). Then as now, DOJ also oversaw the immigration courts, 
through the Executive Office for Immigration Review (EOIR). It is thus 
consistent with the Flores Settlement and child welfare interests for 
independent adjudicators within the same agency to preside over these 
hearings. Note, under the rule, HHS would provide independent bond 
hearings, but any immigration judges would continue to adjudicate UAC's 
removal proceedings.
    Question. Please explain how changing bond hearings from an opt-out 
to an opt-in process is consistent with the Flores Settlement.
    Answer. For policies related to requesting a Flores bond hearing, 
see ORR Policy Guide, section 2.9 Bond Hearings for Unaccompanied Alien 
Children (available at: https://www.acf.hhs.gov/orr/resource/children-
entering-the-united-states-unaccompanied-section-2#2.9). The Flores 
Final Rule's hearing process is consistent with the current process.
    Currently, the Flores bond hearing process for UAC is, effectively, 
an opt-in process. This is because, as a result of changes in the law 
since the Flores Agreement was signed, very few UAC actually benefit 
from them. In the ORR context, bond hearings only determine whether a 
child is a danger to self or others. Very few children are ever 
determined to be a danger to self or others such that this decision 
would impact their release from ORR custody. Therefore, in all other 
instances, the hearings would be uncontested with both parties agreeing 
that there was no issue of dangerousness to be decided by the 
immigration judge. Children that ORR determines are a danger to self or 
others are given instructions on how to request a Flores bond hearing. 
(Note, ORR does not make release decisions based on risk of flight).
    Question. Your recent proposed regulatory changes do not require 
that children receive ``instruction and educational and other reading 
materials in such languages as needed,'' as required by Flores 
Settlement Exhibit 1 (A)(4). Your agency's response to this omission 
was that ``[i]n practice, most educators who teach at FRCs are 
bilingual, typically in English and Spanish, and provide individualized 
education in a manner designed to be most effective for the minor.'' 84 
Fed. Reg. at 44,440. That response clearly misses the point- while a 
teacher may be bilingual in English in Spanish, that has nothing to do 
with the provision of instructional materials in the appropriate 
language, and many children in government custody do not speak either 
English or Spanish.
    Please explain how the regulation's language is consistent with the 
education requirements in the Flores Settlement.
    Answer. The provision referenced is part of the DHS portion of the 
final rule, related to educational requirements in Family Residential 
Centers (FRCs) managed by Immigration and Customs Enforcement (ICE). 
Because it does not refer to ORR, HHS defers to DHS for a response.
    Question. Please explain how flouting the Flores Settlement's 
education requirements is in the best of interest of children.
    Answer. See response to question 7(a). HHS defers to DHS for a 
response.
            fiscal year 2021 budget request for cdc and nih
    Question. In a bipartisan move last December, Congress approved a 
$25 million investment in research to prevent gun deaths with the 
Centers for Disease Control (CDC) and the National Institute of Health 
(NIH). You were tasked with the mission to help reduce the needlessly-
high rates of gun death. Gun violence and suicide continue to kill over 
40,000 people annually in the United States. Yet your budget 
justifications for the CDC and NIH appear to zero out continued funding 
to study this problem.
    Have the CDC and NIH already accomplished the mission of reducing 
gun deaths in the 3 months since funding was given to the CDC and NIH?
    Answer. On February 21, 2020, CDC released a new research funding 
opportunity announcement to solicit investigator-initiated research to 
understand and prevent firearm-related injuries, deaths, and crime. CDC 
anticipates supporting up to 20 research grant awards in fiscal year 
2020. The total amount awarded, and the number of awards will depend 
upon the number, quality, and cost of applications received and 
selected for funding.
    On March 20, 2020, NIH published two Funding Opportunity 
Announcements (FOAs) in the NIH Guide for Grants and Contracts \11\ and 
on Grants.gov--Search Grants.\12\ Research encouraged by these FOAs is 
consistent with a broad public health approach to firearm injury and 
mortality prevention including identifying those at risk for firearm 
injury and mortality (both victims and perpetrators), development and 
evaluation of theoretically-grounded programs to prevent firearm injury 
and mortality, and implementation research to explore the barriers and 
facilitators to support broader adoption of effective programs.
---------------------------------------------------------------------------
    \11\ https://grants.nih.gov/funding/index.htm.
    \12\ https://www.grants.gov/web/grants/search-grants.html.
---------------------------------------------------------------------------
    Question. If not, please explain why you've proposed to eliminate 
funding for this lifesaving research.
    Answer. We take our responsibility for supporting research on 
mental illness and causes of violence seriously. Congress provided 
funds in fiscal year 2020 for firearm mortality prevention research, 
and CDC and NIH are already underway to operationalize that funding. 
However, in drafting the fiscal year 2021 Budget we faced difficult 
choices in order to rein in spending and put America on a sustainable 
financial path, and we have prioritized programs that provide direct 
services and focus on infectious diseases and emergency preparedness 
and response activities.
    The Budget includes $24 million for the National Violent Death 
Reporting System (NVDRS). In fiscal year 2021, CDC will support 52 
recipients to collect NVDRS data. Since fiscal year 2018, CDC has 
expanded the NVDRS to all 50 States and DC. In addition, we invest in 
Project AWARE and other activities that seek to address youth and young 
adult mental health to help improve school safety., These activities 
receive an increase to $156 million (+$2 million above fiscal year 
2020) for mental health services and training to recognize signs and 
symptoms of mental disorders, particularly serious mental illness.
    NIH invests in research on a full range of threats to Americans' 
well-being, and that includes violence with firearms.
 fiscal year 2021 budget request for the bureau of primary health care
    Question. In fiscal year 2019 and fiscal year 2020 this committee 
included language in the conference report supporting the work of the 
Bureau of Primary Health Care (BPHC) in facilitating better 
coordination between health centers and home visiting programs, 
specifically encouraging BPHC to indicate how home visiting programs 
fit within health centers' scope of practice.
    We know that enhanced integration between healthcare providers and 
home visiting programs like Nurse-Family Partnership can help transform 
the lives of mothers working to lift themselves and their children out 
of poverty and the poor health outcomes that come along with living in 
poverty. These programs are skilled at reaching underserved populations 
and can serve as a worthwhile supplement to the primary care provided 
by health centers.
    Nurse-Family Partnership is an example of one of these programs. 
NFP partners first-time, at- risk mothers with registered nurses early 
in pregnancy, working with them through their child's second birthday 
to improve a range of health and child development outcomes. NFP 
currently partners with 22 health centers throughout the country--
including in my state--resulting in improved livelihoods for moms and 
babies who are enrolled in NFP.
    What progress has the Department made in improving coordination 
between health centers and home visiting programs? What is your 
perspective on how home visiting programs fit within the scope of 
practice for health centers?
    Answer. HRSA has convened health centers and HRSA-funded home 
visiting program participants to increase knowledge and awareness of 
the respective programs, build sustainable partnerships, and facilitate 
integration of the services they offer, to the extent possible, with 
the shared goal of improving maternal and child health outcomes. The 
following is an update on this collaboration:
  --In June 2019, HRSA hosted a webinar titled, ``Primary Care and Home 
        Visiting Partnerships to Promote Maternal and Children 
        Health''. The objective of the webinar was to provide an 
        overview of evidence-based home visiting programs and 
        demonstrate how health center and home visiting programs can 
        support one another in improving patient outcomes.
  --In September 2019, HRSA hosted a webinar titled, ``Strategies for 
        Addressing Maternal Depression through Primary Care and Home 
        Visiting Partnerships''. The objectives of this webinar were 
        to: (1) provide an overview of the scope and impact of maternal 
        depression; (2) discuss how primary care and home visiting 
        partnerships can enhance efforts to prevent, identify, and 
        treat maternal depression; and (3) share insights from maternal 
        depression subject matter experts from the HRSA-funded Home 
        Visiting Collaborative Improvement and Innovation Network (HV 
        CoIIN), administered through HRSA's Maternal and Child Health 
        Bureau (MCHB).
  --MCHB funded a cooperative agreement awarded to the National Nurse-
        Led Care Consortium (NNCC). NNCC partnered with the Nursing-
        Legal Partnership Model for Community Health Centers, funded 
        through MCHB, to facilitate a learning collaborative and 
        develop training and technical assistance resources for health 
        centers. This learning collaborative consists of health centers 
        and community partners to explore the efficacy of evidence-
        based home visiting programs, such as Nurse-Family Partnership 
        and Parents and Teachers, for health centers.
    Our HRSA collaboration activities to date have shown that health 
centers can work closely with evidence-based home visiting programs to 
ensure that a comprehensive range of supportive services are made 
available to the families and children that both programs serve.
                                 ______
                                 
              Questions Submitted by Senator Brian Schatz
                              coronavirus
    Question. Does the Department of Health and Human Services plan to 
fully reimburse States for the costs they are incurring as part of the 
Federal Government's coronavirus response?
    Answer. With funding appropriated through the Coronavirus Aid, 
Relief and Economic Security (CARES) Act and the Paycheck Protection 
Program and Health Care Enhancement (PPPHCE) Act, HHS is providing 
relief funds to hospitals and other healthcare providers on the front 
lines of the coronavirus response. This Provider Relief Fund (PRF) will 
be used to support healthcare-related expenses or lost revenue 
attributable to COVID-19 and to ensure uninsured Americans can get care 
related to COVID-19. HHS began issuing payments on April 10 and will 
continue making payments on a rolling basis until the funds are 
expended. While not directly linked to State coronavirus expenditures, 
relief payments are being provided to healthcare providers across all 
50 States and the District of Columbia. Information about disbursements 
will be posted on the HHS website and updated on a regular basis.
    For example, a State-by-State breakdown of the initial $30 billion 
distribution is available at: https://www.hhs.gov/sites/default/files/
state-by-state-breakdown-delivery-of-initial-30-billion- cares-act.pdf.
    Question. Has HHS provided guidelines to states on how they should 
track the costs they are incurring as part of the Federal government's 
coronavirus response? If not, when will HHS provide such guidelines?
    Answer. HHS has not issued any additional specific guidance to 
States to track costs they incur under COVID-19 emergency supplemental 
appropriations. Recipients are required to track and report costs per 
45 CFR 75 and are subject to Part F audit requirements, as is standard 
with all awards.
    Question. Secretary Azar stated that emergency supplemental funding 
would be used in five key areas of response. Please provide more 
information on each of those five areas, and how funding will be used 
in those areas.
    Answer. First, funds are being used to expand our surveillance 
work, building on existing systems we have within CDC's influenza 
surveillance network. Second, funds are supporting public health 
preparedness and response for State and local governments . Third and 
fourth, funds are supporting the development of therapeutics and the 
development of vaccines. Finally, funds are being used for the purchase 
of personal protective equipment for the Strategic National Stockpile.
                        tobacco and youth vaping
    Question. Given that the 2019 National Youth Tobacco Survey found 
that types of open-tank systems that can be filled with thousands of 
flavored e-liquids are among the most popular e-cigarette devices among 
high school students, what is the justification for leaving all open-
tank and menthol-flavored products on the market? Does HHS have 
evidence that youth will not simply switch to those products? If yes, 
please provide that evidence.
    Answer. FDA focused its enforcement priorities-consistent with the 
best available data-on flavored, cartridge-based ENDS products (other 
than tobacco- and menthol-flavored). Importantly, FDA is also 
prioritizing enforcement against all other products (both cartridge-
based or otherwise) including menthol-, tobacco-, and non-flavored ENDS 
products for which the manufacturer has failed to take adequate 
measures to prevent minors' access, as well as all ENDS products that 
are targeted to minors or likely to promote use of ENDS by minors. 
Additionally, should FDA become aware of an increase in youth using 
non-cartridge-based and menthol- and tobacco-flavored cartridge-based 
ENDS products, the Agency may revise its enforcement priorities.
    Additionally, under the policy tobacco- and menthol-flavored 
cartridge-based ENDS products, along with all other ENDS products, are 
subject to the September 9, 2020, submission date for marketing 
applications. FDA intends to prioritize enforcement of all ENDS 
products offered for sale after September 9, 2020, and for which the 
manufacturer has not submitted a premarket application.
    This approach strikes an appropriate balance between restricting 
youth access to such products, while maintaining the availability of 
potentially less harmful options for current and former adult smokers 
who have transitioned or wish to transition completely away from 
combusted tobacco products.
    FDA is continuously evaluating new information and adjusting its 
enforcement priorities in light of the best available data, and it will 
continue to do so with respect to these products. FDA will take 
appropriate action regarding tobacco products that are marketed without 
premarket authorization, including as warranted based on changed 
circumstances, new information, or to better address minors' use of 
those products.
    FDA is prioritizing cartridge-based ENDS products, in part because 
data from the 2019 NYTS indicate that youth overwhelmingly prefer these 
types of ENDS products,\13\ and the Agency has found that these 
products are easy to conceal, can be used discreetly, may have a high 
nicotine content, and are manufactured on a large scale. The 2019 
survey instrument included a measure for the ``usual brand'' of e-
cigarette used in the past 30 days. Most youth who were current e-
cigarette users reported a cartridge-based e-cigarette as their usual 
brand.\14\ In fact, the leading brand is a cartridge-based product that 
commands approximately 70 percent of the market.\15\
---------------------------------------------------------------------------
    \13\ Cullen, K.A., A.S. Gentzke, M.D. Sawdey, ``E-cigarette use 
among youth in the United States, 2019,'' JAMA, 322(21);2095-2103, 
2019.
    \14\ Id. Unpublished data from the 2019 survey list other brands 
that are used by youth, some of which are available in both cartridge-
based and non-cartridge-based forms.
    \15\ Nielsen Total US xAOC/Convenience Database & Wells Fargo 
Securities, LLC, in Wells Fargo Securities, Nielsen: Tobacco All 
Channel Data Thru 10/4--Cig Vol Declines Moderate, October 15, 2019.
---------------------------------------------------------------------------
    While FDA does not currently have data specific to youth switching 
to other products, the Agency will closely monitor the marketplace and 
make adjustments as necessary.
    Question. Since FDA's enforcement policy against certain 
unauthorized flavored e-cigarette products was announced, what has FDA 
done to monitor whether rates of e-cigarette use among youth are 
declining, or whether youth are switching to other flavored products? 
Please provide any data that is available.
    Answer. The Agency is closely monitoring the use rates of all types 
of e-cigarette products, including disposable products, tobacco, and 
menthol flavored e-cigarettes among youth. FDA utilizes multiple 
strategies for monitoring youth use of tobacco, including traditional 
surveillance (such as national surveys) as well as social media 
monitoring and monitoring complaints to reporting systems. National 
surveys and other monitoring approaches are on-going.
    On November 5, 2019, findings from the 2019 National Youth Tobacco 
Survey (NYTS) showed that more than 5 million youth were current (past 
30-day) e-cigarette users in 2019, reaching an alarming level for the 
second year in a row. The prevalence of current e-cigarette use was 
27.5 percent among high school students and 10.5 percent among middle 
school students. The data also showed that the majority of youth who 
currently only used e-cigarettes used a flavored e-cigarette. Among 
high school exclusive e- cigarette users, the NYTS measured a 
significant increase in the use of menthol- and mint-flavored e-
cigarettes from 2016-2019, however because the NYTS survey instrument 
groups mint- and menthol-flavored products together, it is not possible 
to differentiate youth use of mint and menthol flavors separately based 
on the NYTS data.
    Data from the 2019 Monitoring the Future Study (MTF) were also 
published on November 5, 2019. These data showed that approximately 
two-thirds of 8th, 10th, and 12th grade students who reported past 30-
day vaping of any nicotine product reported using JUUL in the past 30 
days. Among those who reported using JUUL in the past 30 days, the use 
of mango- and mint-flavored JUUL ranked highest, followed by fruit- 
flavored. The reported use of menthol and tobacco flavors were among 
the lowest ranked options.
    In January 2020, FDA finalized a guidance outlining our enforcement 
priorities for ENDS products and other unauthorized deemed tobacco 
products. The Agency is prioritizing enforcement against illegally 
marketed ENDS that appeal to children by focusing on flavored, 
cartridge-based ENDS products (other than tobacco- or menthol- 
flavored). Additionally, the Agency will prioritize enforcement against 
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.
    The 2020 National Youth Tobacco Survey (NYTS) is currently in data 
collection mode. FDA is working with CDC to get access to this data as 
soon as possible.
    Question. What steps has the FDA taken to monitor the marketplace 
for products that may be renamed as menthol products so that the 
enforcement policy does not apply?
    Answer. FDA will monitor the marketplace for products that may be 
renamed as menthol products to try to evade enforcement. FDA's decision 
as to whether to take action with respect to particular products will 
be determined on a case-by-case basis, informed by the enforcement 
priorities described in its compliance policy and any other relevant 
factors. Additionally, for all unauthorized ENDS products, including 
tobacco-, menthol-, or non- flavored e-cigarette products, FDA intends 
keep a close watch on--and prioritize enforcement against--products for 
which the manufacturer has not taken or is not taking adequate measures 
to prevent minors' access to these products.
    The final guidance also outlines FDA's intent to prioritize 
enforcement of any ENDS product that is offered for sale in the United 
States after May 12, 2020, and for which the manufacturer has not 
submitted a premarket application. The Agency also retains 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 these categories of enforcement priorities.
    Question. The FDA has promoted the use of its ``Age Calculator'' 
smartphone application as a tool for retailers to use in implementing 
the new tobacco to 21 policy. However, this age calculator does not 
verify the authenticity of driver licenses and other forms of 
identification. What steps has FDA taken to inform retailers that the 
age calculator does not authenticate identification?
    Answer. FDA has a number of tools to assist retailers in complying 
with the new Tobacco 21 legislation. This includes detailed training to 
help retailers calculate the age of tobacco purchasers and comply with 
the law. These resources include FDA's This is Our Watch retailer 
assistance materials that includes an age calculation calendar and the 
FDA Age Calculator smartphone application (app), as well as the Tobacco 
Retailer Training Programs guidance document \16\ and a ``Tips for 
Retailers'' compliance training webinar,\17\ which, among other things, 
help retailers determine whether identification is valid.
---------------------------------------------------------------------------
    \16\ This guidance does not reflect the new minimum legal sale age 
of 21 and is cited here as setting out nonbinding recommendations for 
how retailers can implement training programs to help with compliance.
    \17\ This webinar does not reflect the new minimum legal sale age 
of 21 and is cited here as setting out general tips on retailer 
compliance with Federal tobacco restrictions.
---------------------------------------------------------------------------
    The FDA Age Calculator app is available for free in both the Apple 
App Store and Google Play. The app is a voluntary smartphone 
application to help retailers comply with the Federal age restriction 
for selling tobacco products. Although the app does not help a retailer 
to determine the validity of the identification, it does assist 
retailers and their employees in accurately calculating the age of the 
purchaser based on the date of birth.
    FDA has promoted this app as a calculator to help retailers 
determine the age of a customer. The description of the app in the app 
stores and the disclaimer provided in the app both contain language 
that indicates that the app is a calculator to determine age and does 
not work in conjunction with third-party systems. As this app does not 
work in conjunction with third-party systems, it differs from software 
used to determine whether identifications are valid. That software must 
interface with national databases and contain a two-part verification 
process in order to validate the data. FDA is exploring additional ways 
to clarify for retailers that the app and calendar do not verify the 
authenticity of an ID. The Agency will keep your office informed of its 
work in this area.
    Although the app and calendar do not authenticate an ID, FDA does 
have other resources to help retailers determine whether identification 
is valid. FDA's Tobacco Retailer Training Programs guidance document 
and ``Tips for Retailers'' compliance training webinar both contain 
information on determining whether a photographic identification is 
valid or might have been altered.
    Question. What is the rationale for why a new agency within HHS to 
regulate tobacco products, instead of the FDA, would do a better job at 
regulation? How would creating such a new agency not create more 
disruption in the regulation of tobacco products at the same time that 
the country faces an epidemic of youth vaping?
    Answer. 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. In addition, this 
reorganization would allow the FDA Commissioner to focus on its 
traditional mission of ensuring the safety of the Nation's drug, food, 
and medical products supply.
    Question. The budget eliminates $230 million in funding for the 
National Tobacco Control Program, and instead proposes an America's 
Health Block Grant of $350 million for all chronic disease prevention 
activities. Mathematically, would this mean that states will spend less 
on tobacco control prevention activities?
    Answer. The fiscal year 2021 President's Budget combines funding 
for tobacco control and other chronic diseases into the America's 
Health Block Grant. States would have the flexibility to organize 
prevention and control efforts and deploy evidence-based interventions 
in a manner that makes the most sense to their jurisdictions and 
circumstances, which could result in some States deciding to spend more 
or less on tobacco prevention and control activities.
    On March 17, 2020, the Administration transmitted an fiscal year 
2021 Budget Amendment to Congress to increase funding for CDC to ensure 
that the Agency has the resources beginning October 1, 2020, to 
continue its critical public health mission. This amendment requests a 
total fiscal year 2021 funding level of $8,329,102,000 for CDC, which 
is $1,328,196,000 above the fiscal year 2021 Budget request. The 
additional funding will support priority CDC activities, including 
additional funding for the proposed America's Health Block Grant to 
allow States and localities to address their most pressing non-
infectious disease activities.
    Question. The CDC calls tobacco prevention a ``public health best 
buy,'' and the National Tobacco Control Program has been shown to 
reduce the number of people who smoke, reduce disease and death, and 
result in significant savings. Data show that every dollar spent on 
tobacco prevention means $55 in savings in tobacco-related healthcare 
savings. Will the elimination of this program and less funding devoted 
to tobacco prevention activities simply increase healthcare spending 
and result in poorer health outcomes?
    Answer. The fiscal year 2021 President's Budget proposes the 
America's Health Block Grant, which will provide flexibility to 
grantees and focus on the leading public health challenges faced by 
States, Tribes, localities, and territories. States that have made 
larger investments in comprehensive tobacco control programs have seen 
larger declines in cigarette sales than the United States as a whole, 
and the prevalence of smoking among adults and youth has declined 
faster as spending for tobacco control programs has 
increased.\18,19,20\
---------------------------------------------------------------------------
    \18\ Farrelly MC, Pechacek TF, Chaloupka FJ. The impact of tobacco 
control program expenditures on aggregate cigarette sales: 1981-2000. 
Journal of Health Economics 2003;22(5):843-59.
    \19\ Tauras JA, Chaloupka FJ, Farrelly MC, Giovino GA, Wakefield M, 
Johnston LD, O'Malley PM, Kloska DD, Pechacek TF. State tobacco control 
spending and youth smoking. American Journal of Public Health 
2005;954(2):338-44.
    \20\ Farrelly MC, Pechacek TF, Thomas KY, Nelson D. The impact of 
tobacco control programs on adult smoking. American Journal of Public 
Health 2008;89(2):304-9.
---------------------------------------------------------------------------
    On March 17, 2020, the Administration transmitted an fiscal year 
2021 Budget Amendment to Congress to increase funding for CDC to ensure 
that the Agency has the resources beginning October 1, 2020, to 
continue its critical public health mission. This amendment requests a 
total fiscal year 2021 funding level of $8,329,102,000 for CDC, which 
is $1,328,196,000 above the fiscal year 2021 Budget request. The 
additional funding will support priority CDC activities, including 
additional funding for the proposed America's Health Block Grant to 
allow States and localities to address their most pressing non-
infectious disease activities.
                 cdc cuts to chronic disease prevention
    Question. Have States requested that HHS combine all chronic 
disease prevention funding into one block grant?
    Answer. The fiscal year 2021 President's Budget carries forward the 
fiscal year 2019 and fiscal year 2020 President's Budget proposals of a 
new 5-year block grant program, America's Health, which will provide 
flexibility to grantees and focus on the leading public health 
challenges faced by States, Tribes, localities, and territories.
    Question. One of your priorities as HHS Secretary is value-based 
care. Every dollar invested in an evidence-based prevention program 
yields over $5 in savings. Therefore, how does this priority align with 
the budget's reduced funding for chronic disease prevention activities?
    Answer. Chronic disease prevention is an important public health 
issue and CDC is committed to continuing our efforts. In constrained 
budget environments difficult decisions must be made across Federal 
agencies, including CDC. CDC will continue to utilize resources 
strategically and effectively. The fiscal year 2021 President's Budget 
carries forward the fiscal year 2019 and fiscal year 2020 President's 
Budget proposals of a new 5-year block grant program, America's Health, 
which will provide flexibility to grantees and focus on the leading 
public health challenges faced by States, Tribes, localities, and 
territories.
    On March 17, 2020, the Administration transmitted an fiscal year 
2021 Budget Amendment to Congress to increase funding for CDC to ensure 
that the Agency has the resources beginning October 1, 2020, to 
continue its critical public health mission. This amendment requests a 
total fiscal year 2021 funding level of $8,329,102,000 for CDC, which 
is $1,328,196,000 above the fiscal year 2021 Budget request. The 
additional funding will support priority CDC activities, including 
additional funding for the proposed America's Health Block Grant to 
allow states and localities to address their most pressing non-
infectious disease activities.
                               telehealth
    Question. The fiscal year 2018 omnibus spending bill (Public Law 
115-141) required HHS to submit a report evaluating the use of 
telehealth under programs and pilots in Medicare, yet this report is 
almost 1 year overdue. When will this report be delivered? Given the 
administration's focus on telehealth, what is the reason for this 
report being so delayed?
    Answer. On May 7, 2020 HHS transmitted the Report to Congress on 
Telehealth in response to report language.
    Section 3704 of the Coronavirus Aid, Relief, and Economic Security 
Act (CARES Act, Public Law 116-136) allows FQHCs and RHCs to be 
eligible to furnish and be paid for distant site telehealth services 
during the COVID-19 public health emergency. In the March 30 IFC, CMS 
is revising Medicare payment rates to implement these changes. Section 
3703 increases Medicare telehealth flexibilities more generally during 
the public health emergency, including eliminating the requirement that 
the provider have an established relationship with a beneficiary before 
using telehealth services. Sections 3705, 3706, and 3707 enhance the 
ability for Medicare providers and beneficiaries to utilize telehealth 
for home dialysis, hospice, and home health during the emergency 
period.
    The fiscal year 2021 President's Budget proposed a comprehensive 
package of legislative proposals to promote rural access to care and 
telehealth in Medicare fee-for-service. We look forward to working with 
Congress on these and other legislative proposals that would further 
expand the availability of telehealth services:
  --Modernize the Medicare Telehealth Benefit to Promote Value-Based 
        Payment.--Medicare payment for telehealth services is 
        statutorily limited to circumstances where beneficiaries 
        receive those services at particular healthcare settings, known 
        as originating sites, and the originating site is located in a 
        rural health professional shortage area or a Federal 
        telemedicine demonstration project. Medicare also limits the 
        types of practitioners that can furnish telehealth services and 
        pays for such services at the same rates as in-person services. 
        This multifaceted proposal expands Medicare Fee-for-Service's 
        telehealth benefit by removing existing barriers to telehealth 
        services for providers participating in Medicare fee-for-
        service advanced Alternative Payments Models, which require 
        more than nominal financial risk. This proposal would also 
        require the Secretary to value telehealth services separately 
        from similar services provided face-to-face for purposes of 
        setting reimbursement rates in Medicare. This proposal broadens 
        beneficiary access to Medicare telehealth services and 
        addresses longstanding stakeholder concerns that the current 
        statutory restrictions hinder beneficiary access, while 
        ensuring Medicare is paying for value over volume.
  --Enhance Medicare Telehealth Services for federally Qualified Health 
        Centers and Rural Health Clinics.--Medicare only pays for 
        telehealth services if furnished by physicians or certain non-
        physician practitioners as the distant site providers to the 
        beneficiaries at certain originating sites located in certain 
        geographic areas. This proposal allows Rural Health Clinics and 
        federally Qualified Health Centers to be distant site providers 
        for Medicare telehealth and reimburses for these services at a 
        composite rate similar to payment for comparable telehealth 
        services under the Medicare Physician Fee Schedule. This 
        proposal levels the playing field by allowing these critical 
        healthcare facilities to participate in the existing Medicare 
        telehealth program. It also increases beneficiary access to 
        care in rural areas where these clinics and centers are often 
        the only source of primary care.
  --Extend Medicare Telehealth Services for IHS and Tribal 
        Facilities.--Medicare covers some types of telehealth services, 
        but does not expressly cover telehealth services provided 
        across State lines. In the Indian Health Service (IHS) system, 
        telehealth practitioners are often located in a different State 
        from the patient and are not licensed, registered, or subject 
        to the law of the State where the patient is located and 
        receiving such services. This IHS proposal allows all IHS and 
        tribal facilities to bill Medicare for telehealth services as 
        originating and distant sites under the Physician Fee Schedule, 
        even if the facility does not meet the requirements for being 
        located in certain rural or shortage areas, including coverage 
        for telehealth services provided across State lines. Explicitly 
        authorizing IHS and tribal health programs to receive Medicare 
        payment as originating and distant sites for telehealth 
        services will accommodate the unique structures and Federal 
        authorities that allow IHS and tribal health programs to 
        operate across State lines.
                              project echo
    Question. I and many of my Senate colleagues recently sent you a 
letter on Project ECHO and other technology-enabled collaborative 
learning and capacity-building models. The letter encourages the 
Department to explore ways to support and sustain the integration of 
these successful models into the healthcare delivery system. Does CMS 
plan to issue guidance to States on financing strategies for these 
models available through existing Medicaid authorities?
    Answer. The Department, including CMS, is always available to 
provide technical assistance to States about models comprised of 
specific services that can be covered and reimbursed by Medicaid. 
Fostering State innovation and pairing it with enhanced accountability 
and integrity can improve health outcomes for beneficiaries, and we 
look forward to hearing how States are exploring ways to successfully 
incorporate ECHO into their Medicaid programs and how participation in 
ECHO has improved beneficiary access to and quality of care.
                                 ______
                                 
           Questions Submitted by Senator Christopher Murphy
    Question. In fiscal year 2020, Congress provided $12.5 million each 
for the CDC and NIH to conduct research on gun violence. The fiscal 
year 2020 Appropriations bill required the Directors of CDC and NIH to 
report to our Committee within 30 days of enactment on implementation 
schedules and procedures for grant awards. I understand the CDC has, 
but the NIH has not yet done so.
    The CDC recently announced a funding opportunity of up to $8 
million for Research Grants to Prevent Firearm-Related Violence and 
Injuries. When will CDC roll out the funding to grantees? The agency 
was appropriate $12.5 million for this field of research. When will CDC 
issue the request for applicants for the remaining $4.5 million it was 
appropriated? When does the NIH plan to issue its request for 
applicants for funding?
    Answer. CDC is working diligently to ensure the research grants to 
prevent firearm-related violence and injuries will be awarded no later 
than September 2020. In addition to directly supporting research, CDC 
is also undertaking efforts to strengthen data at the local, State, and 
national level. Improving data to monitor the burden of firearm deaths 
and injuries and answer research questions is critical to advance 
Firearm Injury and Mortality Prevention efforts. CDC will also retain a 
portion of the Congressional appropriation for staffing and operations 
to support these efforts.
    The NIH Report to Congress on firearms research was sent to the 
Committee on January 31st.
    On March 20, 2020, NIH published two Funding Opportunity 
Announcements (FOAs) in the NIH Guide for Grants and Contracts \21\ and 
on Grants.gov--Search Grants.\22\ Research encouraged by these FOAs is 
consistent with a broad public health approach to firearm injury and 
mortality prevention including identifying those at risk for firearm 
injury and mortality (both victims and perpetrators), development and 
evaluation of theoretically-grounded programs to prevent firearm injury 
and mortality, and implementation research to explore the barriers and 
facilitators to support broader adoption of effective programs.
---------------------------------------------------------------------------
    \21\ https://grants.nih.gov/funding/index.htm.
    \22\ https://www.grants.gov/web/grants/search-grants.html.
---------------------------------------------------------------------------
  --NOT-OD-20-089, Notice of Special Interest: Competitive Revisions 
        for Firearm Injury and Mortality Prevention Research.\23\ This 
        Notice solicits competitive revision applications to support 
        the expansion of existing R01 and R21 programs well poised to 
        expand their focus to include firearms research.
---------------------------------------------------------------------------
    \23\ https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-
089.html.
---------------------------------------------------------------------------
  --PAR-20-143, Firearm Injury and Mortality Prevention Research (R61 
        Clinical Trial Optional).\24\ This Program Announcement with 
        special receipt, referral, and/or review considerations (PAR) 
        invites new research applications to improve understanding of 
        the determinants of firearm injury, the identification of those 
        at risk of firearm injury (including both victims and 
        perpetrators), the development and evaluation of innovative 
        interventions to prevent firearm injury and mortality, and the 
        examination of approaches to improve the implementation of 
        existing, evidence- based interventions to prevent firearm 
        injury and mortality.
---------------------------------------------------------------------------
    \24\ https://grants.nih.gov/grants/guide/pa-files/PAR-20-143.html.
---------------------------------------------------------------------------
    Please refer to the FOAs for a detailed description of priority 
areas. Awards will be funded by September 30, 2020.
    Question. The SUPPORT for Patients and Communities Act included 
``Sec. 1001. At-risk youth Medicaid protection'' to prevent a State 
from terminating a young person who is otherwise eligible for Medicaid 
because he or she is in the juvenile justice system. This allows a 
young person to continue treatments and other healthcare coverage 
immediately following release.
    What is the status of Medicaid guidance to assist States in 
adopting section 1001 of the SUPPORT for Patients and Communities Act?
    Answer. Guidance to States on section 1001 of the SUPPORT for 
Patients and Communities Act is under development. To support States in 
their efforts to implement the provision, CMS hosted a webinar for 
State staff on strategies for connecting justice involved populations 
to substance use disorder treatment. The webinar iterated the 
intersection of Medicaid and justice involved populations, including 
State Medicaid coverage initiatives.
    Question. Research shows that the early years of a child's life 
offer the best opportunity to shape key academic, social, and cognitive 
skills that lay the foundation for future success. Authorizing the 
Preschool Development Grant Birth through Five (PDG B-5) program 
through the Every Student Succeeds Act (ESSA) was critical to improve 
program quality, collaboration, and transitions within early learning 
and care programs. Although 46 States applied for funding this past 
year, only 20 States, including my home State of Connecticut, were 
awarded funding due to budget constraints. States rely on this funding 
to coordinate existing early childhood services and serve more children 
effectively in a mixed delivery system, and while there has been an 
increase in the number of children enrolled in preschool in the United 
States, children still have uneven access to quality, affordable 
programs.
    What is the administration's reasoning for proposing to eliminate 
the PDG B-5 program when there is overwhelming interest and need for 
these programs across the country? How would the department ensure that 
States are improving the overall quality of their early childhood 
education programs if this program were to discontinue?
    If PDG B-5 is funded in fiscal year 2021, how can the Federal 
Government leverage States' best practices for improving coordination 
of existing early childhood services and funding streams to improve the 
use of Federal funds and overall quality of early childhood education 
programs, while ensuring equitable access to early learning 
environments?
    Answer. We have already created a template for States to annually 
share best practices, efforts to blend and braid funding, new and 
improved partnerships, innovative practices or new procedures, new 
policies or legislation that has come about as a result of PDG B-5 
funding, successful efforts made to improve the access to and quality 
of early childhood care and education programs, any infrastructure, 
policy, governance and/or funding put in place to sustain the 
strategies and activities going forward, and improvements in meaningful 
parent engagement activities. As mentioned previously, we will be 
including all States in any upcoming webinars, sharing any new tools or 
resources developed, alerting them to other funding opportunities made 
available by other Federal agencies, and inviting all States to 
participate in any annual meetings or other learning events where they 
can share and learn about best practices and lessons learned with one 
another.
    Question. In 2016, the FDA proposed to ban electrical stimulation 
devices (ESDs) used for self-injurious or aggressive behavior because 
they present an inhumane and substantial risk to public health and they 
have been used on children with intellectual and developmental 
disabilities. The agency recognizes that these devices present 
substantial and unreasonable risks of illness or injury that cannot be 
corrected or eliminated by labeling or a change in labeling.
    When will the FDA issue the final ban of ESDs used to treat self-
injurious or aggressive behavior?
    Answer. On March 4, 2020, FDA published a final rule to ban 
electrical stimulation devices (ESDs) used for self-injurious or 
aggressive behavior because they present an unreasonable and 
substantial risk of illness or injury that cannot be corrected or 
eliminated through new or updated device labeling. More information is 
available on its website here: https://www.fda.gov/news-events/press-
announcements/fda-takes-rare-step-ban-electrical-stimulation-devices-
self-injurious-or-aggressive-behavior.
    The final rule is available here: https://www.regulations.gov/
document?D=FDA-2016-N-1111-1743.
    Question. The FDA has yet to formally begin the rulemaking process 
for medical gas, despite having the authority to do so since 1978. In 
2012, Congress enacted historic and bipartisan reforms for medical 
gases in the Food and Drug Administration Safety and Innovation Act 
(FDASIA Section 1112) that required FDA to promulgate new regulations 
for medical gases by July 9, 2016. When that statutory deadline was 
missed, the fiscal year 2017 Consolidated Appropriations Act pressed 
the agency to do so by July 2017. In 2018, the FDA convened three 
public meetings with stakeholders, with a proposed rule on medical 
gases included in all subsequent Unified Agendas.
    When does the FDA plan to issue the proposed rule for medical 
gases?
    Answer. FDA is actively working to revise Federal drug regulations 
with respect to medical gases. As you have noted, FDA has held three 
comprehensive public workshops that have covered several areas of FDA's 
regulation of medical gases, including labeling, current good 
manufacturing practice, postmarket safety reporting, certification of 
designated medical gases, and drug registration and listing. The Agency 
is also actively considering proposed regulatory changes submitted to 
the public docket by stakeholders as FDA develops revisions to the drug 
regulations that apply to medical gases. The proposed rule is listed on 
the public Unified Agenda which can be found at: https://
www.reginfo.gov/public/do/eAgendaViewRule?
pubId=201910&RIN=0910-AH96.
    The Agency understands the need for drug regulations to be better 
tailored to medical gases and intends to issue a comprehensive proposed 
rule.
    Question. The Department recently implemented reforms to how livers 
are allocated for transplant. In regions such as New England, there are 
sick patients who recently received liver transplants who would 
otherwise have died under the previous allocation system. The new liver 
distribution system is working and the most urgently ill patients are 
the beneficiaries.
    Will the Department continue to uphold the new policy that 
prioritizes the medical needs of patients?
    Answer. The Organ Procurement and Transplantation Network (OPTN) 
implemented the new liver and intestinal organ distribution policy, 
referred to as the Acuity Circles policy, on February 4, 2020. The new 
policy replaces the use of decades-old geographic boundaries of 58 
donation service areas and 11 transplant regions. It emphasizes the 
medical urgency of liver transplant candidates.
    The OPTN is responsible for organ allocation policy and Health 
Resources and Services Administration (HRSA) is charged with oversight 
of the OPTN. Please be assured that HRSA and the OPTN are committed to 
the equitable allocation of livers for transplantation for patients 
across the country and will carefully monitor the outcomes of the 
Acuity Circles policy.
                                 ______
                                 
            Questions Submitted by Senator Joe Manchin, III
                              coronavirus
    Question. Secretary Azar, the President sent a letter to Congress 
requesting an additional $2.5 billion to help combat the spread of 
coronavirus. This request includes $1.25 billion in new funding through 
the Department of Health and Human Services, as well as requests to 
shift other funding within HHS to prioritize response to this disease. 
With almost 79,000 cases in 30 countries, and 14 confirmed cases in 
seven States in the U.S., we need to ensure that our hospitals and 
local health departments are prepared. Our State and local health 
departments are on the front lines of the response to this virus, and 
major investments are needed to ensure the Nation's health. In West 
Virginia we have 31 Community health Centers that serve over 467,000 
people across the State, representing 1 in 4 West Virginians.
    Secretary, what is your estimate of the need for continued response 
at the Federal, state, and local level if this virus starts to spread 
among the community?
    To sustain this, do you think more funding is needed at each level?
    Answer. As you know, the President, HHS, and Congress worked 
closely together to create and pass an $8.3 billion supplemental 
funding package, the Coronavirus Preparedness and Response Supplemental 
Appropriations Act, 2020. On March 11, five days after the President 
signed the supplemental funding bill, HHS announced that over $560 
million will go to State, local, territorial, and Tribal governments. 
This funding will support surveillance, epidemiology, laboratory 
capacity, infection control, mitigation, communications, and other 
preparedness and response activities. The supplemental appropriation 
augments HHS's response and focuses on five priorities: (1) expanding 
our surveillance work; (2) providing funds to support public health 
preparedness and response for State and local governments; (3) 
developing therapeutics; (4) developing vaccines; and (5) funding the 
purchase and manufacture of personal protective equipment for the 
Strategic National Stockpile.
    The Department has received additional supplemental funding to 
support Coronavirus. The Second Coronavirus Preparedness and Response 
Supplemental Appropriations Act, 2020 in the Family First Coronavirus 
Response Act, enacted March 18, 2020 (Public Law 116-127), provided 
$1.314 billion in emergency supplemental funding to the Department of 
Health and Human Services (HHS) for Coronavirus preparedness and 
response activities. With these resources, HHS will support COVID-19 
testing capacity across the Indian Health system; provide nutritious 
meals via home-delivery, drive-thru, and grab-and-go options for 
vulnerable older adults; and reimburse providers for the cost of COVID-
19 testing for uninsured patients. The Coronavirus Aid, Relief, and 
Economic Security (CARES) Supplemental Appropriations Act provided 
$142.8 billion in emergency supplemental funding to the Department for 
Coronavirus preparedness and response activities. The Payback 
Protection Program and Health Care Enhancement Act provided $100 
billion, which includes $11 billion in awards to States, Territories, 
Tribes, and localities to develop, purchase, administer, process, and 
analyze COVID-19 tests, conduct surveillance, trace contacts and 
related activities. The Department continues to assess response needs 
as we monitor the development of COVID-19.
                         preexisting conditions
    Question. There are over 800,000 West Virginians and 133 million 
Americans living with a pre-existing condition. Their ability to access 
affordable healthcare literally hangs in the balance as the courts 
continue to review Texas V U.S. The healthcare laws on the books today 
include clear protections that prohibit insurance companies from 
discriminating against individuals with pre-existing conditions. With 
the future of the ACA in the balance, your budget provides no 
alternative, no replacement, no hope for the Americans with pre-
existing conditions. Additionally, your budget continues to push the 
sale of short-term or ``junk'' health plans that threaten access to 
quality and affordable care for Americans with pre-existing conditions. 
These plans make it easier for insurance companies to discriminate 
against people who desperately need prescription drugs, maternity care, 
and mental health or substance use disorder treatment.
    Secretary, will you commit to working with me to build on the 
successes of the ACA to protect and expand access to affordable 
healthcare for all Americans?
    Answer. The Trump Administration stands ready to work with Congress 
on policy solutions that increase affordability while continuing to 
protect individuals with pre-existing conditions. The Supreme Court 
will consider in its next term whether the Affordable Care Act's 
individual mandate is unconstitutional and, if so, the status of the 
remainder of the Act. Meanwhile, HHS will continue administering and 
enforcing all aspects of the ACA as it had before the Fifth Circuit 
issued its decision.
    Americans have the best healthcare in the world, but rising costs 
are an unsustainable financial burden for too many Americans and, 
increasingly, too many States. President Trump's Health Reform Vision 
will protect the most vulnerable, especially those with pre-existing 
conditions, while also providing the affordability, choice, and control 
that Americans want, along with the high-quality care that all 
Americans deserve. Right now, many Americans, particularly those who do 
not qualify for subsidies, are being priced out of insurance coverage 
or left with coverage options that do not fit their needs. This 
Administration's efforts to expand access to affordable coverage, such 
as short-term, limited- duration insurance, offer needed options, 
particularly for many middle-class Americans without employer-sponsored 
coverage who are not eligible for subsidies under the ACA. These plans 
may not work for everyone and may not offer the same benefits as other 
plans, but they can provide dramatically more affordable options, and 
for those Americans who are priced out of ACA-compliant plans, access 
to short-term, limited-duration insurance may mean the difference 
between some insurance and no insurance at all. In the final rule, we 
instituted robust notice requirements for informing consumers about the 
limits of this type of coverage so consumers can understand what they 
are purchasing. Both the CMS Office of the Actuary and the 
Congressional Budget Office estimate that this the expansion of short- 
term, limited-duration plans through this rule will increase the number 
of people with some type of health insurance coverage.
                             opioid funding
    Question. Secretary Azar, my State of West Virginia has been 
devastated by the opioid epidemic. We are the hardest hit State in the 
Nation and have the highest overdose death rate. Our State also faces 
the largest per-capita economic burden in the country: the opioid 
epidemic is costing our economy an estimated $8.8 billion per year, 
forcing us to dedicate the largest share of our GDP of any State to 
costs related to the crisis: 12 percent. This is a staggering cost for 
a small State like ours. That is why I pushed for and was glad to see 
the 15 percent set aside for the hardest hit states--those with the 
highest mortality rates like West Virginia. However, recent studies 
have shown that rural counties are still not getting their fair share. 
The study found a number of rural counties, including 40 of 95 in one 
State, received no direct Federal funding.
    Will you commit to working with me to ensure that rural counties 
with high mortality rates related to opioid overdoses get the share of 
the Federal resources that they need to address this crisis, including 
of Federal funding not subject to the 15 percent set aside requirement?
    Answer. SAMHSA is committed to ensuring all communities with need 
receive the necessary resources to provide the full array of substance 
use disorder prevention, treatment, and recovery support services. The 
2018 and 2019 State Opioid Response (SOR) funding was awarded to States 
via formula and State allocations were based on the following two 
elements weighted equally: 1. The State's proportion of people who meet 
criteria for dependence or abuse of heroin or pain relievers who have 
not received any treatment (NSDUH 2015-2016), and 2. The State's 
proportion of drug poisoning deaths (2016 CDC Wide-ranging ONline Data 
for Epidemiologic Research (WONDER)). States are expected to distribute 
the funds throughout their communities based on the needs assessment 
conducted for their State Targeted Response (STR) grant. Based on West 
Virginia's needs assessment, they have prioritized geographic areas and 
populations at higher risk for opioid use disorder (OUD) and on 
pregnant and parenting women. Grantees are specifically encouraged to 
use innovative telehealth strategies in rural and underserved areas to 
increase the capacity of communities to support OUD prevention, 
treatment and recovery. To accomplish this goal, most States contract 
with universities, community organizations, local governments, and 
other entities to provide the relevant services needed within the 
communities.
    In West Virginia specifically, individuals with OUD are eligible to 
receive free public transit to the States' treatment centers. The West 
Virginia Public Transit Association provides both urgent and non-urgent 
transport available within 24 to 72 hours. This initiative aims to 
improve access to treatment and recovery resources to individuals, 
families and communities across the State. West Virginia has also 
expanded its Comprehensive Opioid Addiction Treatment (COAT) program. 
The COAT program has developed four regional Hubs in addition to WVU's 
mega-hub and is standing up spokes to provide treatment and support 
services in geographically isolated and underserved areas of the State. 
To date, through SOR funding, the COAT program has added 14 facilities 
(spokes) to its treatment system. SAMHSA is engaged in several 
activities and is developing products specifically related to rural 
communities, including:
  --Rural Emergency Medicine Services Training Program
  --Rural Opioid Technical Assistance Program
  --SAMHSA Advisory: Addressing Opioid Use Disorder in Rural and 
        Frontier Communities
  --Partnering with USDA to Create Recovery Housing in Rural 
        Communities
    SAMHSA will continue to support efforts and explore ways to address 
OUD in underserved, including rural communities.
                      homeless children and youth
    Question. Secretary Azar, as you may be aware, most recent Federal 
data reports more than 1.5 million students experienced homelessness in 
the 2017-2018 school year. In my State of West Virginia, we had more 
than 10,500 students identified as homeless during the last school year 
alone. However, we know that both numbers are much higher due to 
challenges associated with identifying and reporting children and youth 
experiencing homelessness. The Administration of Children and Families 
(ACF) is tasked with promoting the economic and social well-being of 
families and children, including those experiencing homelessness. I am 
pleased to know that ACF hosted a number of listening sessions in 2019 
across this country to better understand the challenges and roadblocks 
that make it more difficult to assist families experiencing 
homelessness. As noted in the report summary of those sessions, family 
homelessness is still increasing in every region of this country, which 
contributes significant trauma for both parents and children. That is 
why I'm most concerned about the section outlining that ACF has 
numerous resources available to assist these families, but those 
resources are ``overlooked and under-appreciated''.
    Can you please outline how the President's budget request for the 
Administration for Children and Families enables and empowers them to 
better assist homeless children and youth along with their families?
    Specifically, how does this budget help expand access to the vital 
resources provided by ACF?
    Answer. The ACF budget promotes work, strong families, healthy 
marriage, strong social networks, and programs to reduce adolescent 
pregnancy, reduce family and youth homelessness, and increase self-
sufficiency. The budget also includes funding for community-based 
interventions that support primary prevention strategies to keep 
families together and reduce the number of children removed for abuse 
and neglect.
    One barrier for individuals and families seeking services is the 
fragmented nature of Federal and State funding. Funds come to States 
and localities primarily through program specific formula or 
discretionary grants appropriated or awarded to government entities, 
tribes, institutions of higher education, and faith-based and community 
organizations. Families and youth do not necessarily look to government 
first when in need of assistance, but many will seek assistance from 
local, community, or faith-based service providers who may or may not 
know about the various resources available unless they create 
intentional partnerships with other nonprofits and/or State agencies.
    Local departments of social services (government) do not generally 
provide services across the ACF continuum as programs are managed by 
the various entities that receive Federal funding including: workforce 
commissions, departments of education, departments of aging and 
disability services, child care providers, Head Start agencies, 
departments of agriculture (SNAP, WIC), health departments (Medicaid 
eligibility), domestic violence facilities, shelters for runaway and 
homeless youth, and others.
    One example of how ACF is working to expand access to resources is 
in the Runaway and Homeless Youth (RHY) program. The RHY program 
encourages grantees to connect youth with local resources including 
those in schools and education systems through McKinney-Vento (M-V) 
liaisons. These liaisons are required to make sure homeless youth are 
enrolled in school receive categorical eligibility for certain 
resources including free textbooks, transportation, and Title I 
services. ACF is also working with colleagues at Department of 
Education to connect the M-V liaisons with State child welfare 
directors, runaway sheltering programs, domestic violence sheltering 
programs, and service providers. ACF serves on the Department of 
Housing and Urban Development workgroup to inform their Foster Youth 
Initiative, a new opportunity for tenant vouchers for youth in need of 
transitional housing.
    Another example of expanding access to resources is the recent 
partnership between ACF's RHY program and Early Head Start. These two 
Federal programs worked together to communicate to their respective 
grantees that pregnant and parenting youth and their young children in 
RHY shelters have priority placement in Early Head Start programs. 
Early Head Start programs focus on teen parents and children 
experiencing homelessness through targeted outreach and facilitated 
enrollment. By combining the resources of both RHY and Early Head 
Start, pregnant and parenting teens, including fathers, receive many 
wrap around supporting services designed to lift them out of poverty 
and onto a trajectory for success.
    The President's Budget supports prevention of homelessness and 
funds systems to ensure that homelessness is temporary and short-term. 
Strategies include expanding access to services and increasing service 
capacity. Examples include:
  --A $1 billion competitive fund to increase the capacity of childcare 
        services for low income working families while stimulating 
        employer investment;
  --A flexible funding proposal for foster care that would allow States 
        to support more prevention services to keep families together 
        in their own homes;
  --Demonstration funding for improving permanency (adoption, 
        guardianship, kinship or other permanent connects) for youth in 
        foster care before they age out of the system and find 
        themselves homeless and in need of services;
  --Continued support for early childhood education by funding Head 
        Start and Child Care for low income working families at 
        historically high levels;
  --Improved enforcement tools to engage more parents in payment of 
        child support while encouraging father engagement and child 
        well-being;
  --Continued funding to develop a model intervention for young adults 
        with child welfare involvement who are at-risk of homelessness;
  --A $16 million increase in Child Abuse Discretionary grant funding 
        to support primary prevention to keep families in their homes 
        and reduce child removals;
  --Continued support ($132 million) for ACF Runaway and Homeless Youth 
        programs to provide comprehensive services to an estimated 
        63,401 homeless youth. The President's Budget also proposes to 
        create a performance-based contracting demonstration program 
        for the Transitional Living and Maternity Group Home programs 
        that will encourage grantees to focus more on outcomes in the 
        design and delivery of their services.
  --Continued support for domestic violence prevention services to 
        include development of safety plans, counseling, peer support 
        and referrals to community services both before and after 
        victims find themselves homeless;
  --Funding to aid foster youth in the successful transition to 
        adulthood including education and housing voucher programs;
  --Over $100 million in support of adolescent pregnancy prevention 
        programs to prevent pregnancy and support youth in setting 
        goals including completion of high school, getting a full time 
        job and waiting until marriage to have children, dramatically 
        reducing their risk of homelessness; and
  --A $40 million increase for Regional Partnership Grants to address 
        the significant problem of substance misuse and child welfare 
        involvement, which may lead to homelessness.
    One of the benefits of the ACF listening sessions on family 
homelessness, was the opportunity for service providers, local 
government agencies, and individuals to learn about the menu of ACF 
programs, meet program staff and regional nonprofit leaders, and 
network with other providers and government leaders. ACF is committed 
to continuing efforts to strengthen collaboration at the Federal, 
State, and local level to increase awareness of and access to ACF-
related services, and critical services provided by other Federal 
partners.
                     the jessica grubb's legacy act
    Question. Secretary Azar, as you know, the 42 CFR Part 2 
regulations govern the confidentiality and sharing of substance use 
disorder treatment records within our healthcare system. Unfortunately, 
at a time when we are working toward greater care coordination, this 
regulation has acted as a barrier to communication between healthcare 
providers serving individuals with substance use disorders. I 
introduced the Jessica Grubb's Legacy Act in honor of a young woman 
that we lost too soon to an opioid overdose because her medical records 
did not adequately indicate her past addiction and--while in recovery--
was sent home from a surgery with 50 oxycodone pills. This bill would 
simply align the privacy standards for substance use disorder treatment 
records with HIPAA--the privacy standard that governs all other 
physical and mental healthcare records. It would preserve patient 
privacy, but ensure that medical professionals have access to the vital 
information that they need to properly coordinate the care of their 
patients with substance use disorders. As the agency that oversees 42 
CFR Part 2, SAMHSA has said that they are encouraged that Congress is 
examining ``the benefits of aligning Part 2 with HIPAA'' because `` 
healthcare providers must have secure access to patient information, 
including substance use disorder information, in order to provide 
integrated and effective care.''
    Secretary Azar, will you commit to working with me to pass the 
Legacy Act (S. 1012) to align Part 2 with HIPAA and ensure that those 
recovering from substance use disorders are able to receive quality, 
coordinated healthcare?
    Answer. Yes, HHS supports the alignment of 42 CFR Part 2 and HIPAA 
Privacy Rule, 45 CFR Parts 160 and 164, Subparts A and E, and was 
pleased to see the Congressional action to align HIPAA and 42 CFR Part 
2 by passing similar language to your bill in the CARES Act. HHS is 
committed to working to reduce barriers to care for those with 
substance use disorders (SUD). HHS believes that the statutory 
provision that 42 CFR Part 2 implements, while well intended, may 
sometimes serve as a barrier to care and has contributed, in some ways, 
to the increased stigma around SUDs. HHS, through the Substance Abuse 
and Mental Health Services Administration (SAMHSA), has worked to 
modify 42 CFR Part 2 regulations through a Notice of Proposed 
Rulemaking Process. SAMHSA has proposed modifications to make it easier 
for primary care providers to receive information from SUD treatment 
facilities and document such information into the providers' records 
without additional burden to the primary care provider. SAMHSA 
proposals also make it easier to communicate in times of emergency and 
would further enhance the ability of patients to get needed benefits 
such as Social Security benefits without additional paperwork.
                              drug testing
    Question. Federal law requires trucking companies to drug test new 
drivers and randomly test existing drivers using methods established by 
the Department of Health and Human Services. FMCSA's newly established 
Drug and Alcohol Clearinghouse has received over 8,000 DOT drug and 
alcohol violations in less than 2 months, and many trucking companies 
have adopted hair testing as a tool to detect drug use into their 
company policies. Unfortunately, while hair testing provides employers 
a longer detection window, ease of collection, and makes it more 
difficult for testers to adulterate than urinalysis, it is not a 
federally-accepted alternative drug testing method. The FAST Act 
mandated that HHS issue technical guidelines for the adoption of hair 
testing as a federally-accepted alternative drug testing method within 
1 year of the bills enactment. While that deadline has long since 
passed, HHS submitted proposed guidelines for OMB review this past 
summer.
    Mr. Secretary, will you commit HHS to providing DOT guidelines that 
will provide trucking companies this safety tool mandated by Congress 
in the FAST Act to ensure that their drivers are not using prohibited 
substances?
    Answer. The Proposal for Mandatory Guidelines for Federal Workplace 
Drug Testing Programs.--Hair is currently under Executive Branch and 
interagency review and coordination. When this process is complete, we 
anticipate publishing the proposed Guidelines in a Federal Register 
Notice.
                                 ______
                                 
            Questions Submitted by Senator Patrick J. Leahy
                  opioid misuse and addiction research
    Question. Opioid abuse and addiction continues to debilitate 
millions of families throughout the United States, particularly in 
rural areas such as Vermont. Preliminary data from the Vermont 
Department of Health shows that in 2018, 110 Vermonters suffered an 
opioid-related fatality (17.6 fatalities per 100,000 Vermonters). 
Nationally, according to the National Institute on Drug Abuse (NIDA), 
the opioids were involved in more than two-thirds of all drug overdose 
deaths in 2017.
    Since fiscal year 2018, Congress has appropriated $1.5 billion to 
the National Institutes of Health (NIH) for research related to opioid 
addiction, development of opioid alternatives, pain management, and 
addiction treatment. In fiscal year 2020 alone, Congress appropriated 
$500 million to NIH for these purposes.
    What programs and initiatives are these funds are supporting, and 
how?
    Answer. The NIH Helping End Addition Long-term (HEAL) Initiative 
seeks to develop scientific solutions to the opioid crisis from all 
angles and disciplines, and across the full spectrum of biomedical 
research. In September 2019, NIH directed $945 million in funding 
towards more than 375 projects across 41 States through the HEAL 
Initiative. Research supported through the Initiative is working to 
discover safer and more effective treatment options for pain, and to 
expedite the development of therapies to treat opioid use disorder and 
overdose. Projects employ a range of approaches, including validation 
of new targets for pain therapeutics, identification of individuals 
most at risk of relapse and opioid overdose, and prevention of at-risk 
adolescents from developing opioid use disorder. Additionally, 
implementation science efforts will seek to integrate evidence-based 
interventions for opioid addiction in healthcare and justice settings 
and in communities in States most affected by the opioid crisis. As 
part of its response to this crisis, NIH intends to maximize the 
availability of HEAL research findings and publications as well as the 
sharing of underlying data to promote dissemination of new knowledge, 
enhance reproducibility, and accelerate research to develop scientific 
solutions to the opioid crisis through the NIH HEAL Initiative 
research.
    Question. What progress has been made at the NIDA and the National 
Institute of Neurological Disorders and Stroke (NINDS) on developing 
non-opioid chronic pain medications to alleviate pain and to treat 
addiction?
    Answer. Studies are underway to identify compounds that target 
receptors and ion channels integral to non-opioid pain pathways in the 
nervous system. Through the HEAL initiative, NIH is supporting 
discovery research on new targets for novel medications and devices to 
treat pain. Many of these studies focus on new receptors and channels 
for treatment of neuropathic pain such as diabetic nerve pain, and 
orofacial pain such as headache and temporomandibular joint pain. In 
addition, NIH supports studies on anti- inflammatory compounds to treat 
chronic pain conditions such as neuropathic pain and osteoarthritis. 
Through the NIH Blueprint Neurotherapeutics Program for drug discovery 
and development, the National Institute of Neurological Disorders and 
Stroke (NINDS) funds studies to develop non-addictive kappa opioid 
receptor antagonists for treatment of migraine and a safe, non-opioid 
analgesic, which is a soluble epoxide hydrolase inhibitor that can be 
taken orally to reduce diabetic nerve pain. NIH supported basic science 
research that led to the understanding of the role of calcitonin gene-
related peptide therapy for migraine and nerve growth factor therapy 
for inflammatory pain. Drugs that target these molecules' function are 
now approved by the FDA to treat migraine and osteoarthritis pain, 
respectively.
    As NIH works to develop new, non-addictive therapies for pain, 
efforts are also underway to find new ways to treat opioid addiction. 
NIDA leads efforts under the HEAL Initiative to support a series of 
targeted studies with the goal of submitting approximately 15 
investigational new drug and five new drug applications to the FDA for 
medications to prevent and treat opioid use disorder (OUD) and 
overdose. The program aims to accelerate the discovery and development 
of novel medications to treat all aspects of the opioid addiction 
cycle, including progression to chronic use, withdrawal symptoms, 
craving, relapse, and overdose. This includes novel formulations of 
existing medications for OUD such a buprenorphine and naltrexone and 
stronger, longer-duration formulations to counteract opioid overdose. 
The program also includes support to study novel medications to treat 
withdrawal, craving, progression and relapse and to identify new 
medication targets to treat OUD. Together, these studies will range 
from early stage drug development to Phase I and Phase II clinical 
trials of drugs. Some of the drugs under investigation target the 
opioid signaling system directly, while others affect novel targets in 
other signaling systems that can play a role in opioid addiction or 
withdrawal which could lead to the development of additional OUD 
treatments that may work better for some patients or have a more 
tolerable side effect profile.
    Question. Could you please explain, with specific examples, how NIH 
has expanded scientific activities related to research on non-opioid 
chronic pain therapies?
    Answer. Through the HEAL Initiative, NIH supports programs to 
accelerate development of new medications and devices to treat pain. To 
test new non-addictive pain treatments, newly established and highly 
innovative preclinical screening platforms will use animal-based and 
human cell-based models such as neural tissue chips for rapid screening 
of molecules or devices for analgesic relevant biological and 
behavioral activity. Through HEAL, NIH is also partnering with academia 
and industry to bring in promising new drugs and devices for early 
phase testing of novel therapeutics in the newly established Early 
Phase Pain Investigation Clinical research network (EPPIC-NET), which 
supports trials on the safety and efficacy of novel drugs and devices. 
This network also will support discovery research on different pain 
conditions. Through HEAL, NIH also established the Pain Management 
Effectiveness Research Network which supports phase III effectiveness 
trials on pharmacological and nonpharmacological therapies for many 
different pain conditions, including post-surgical pain, chronic 
musculoskeletal pain, knee osteoarthritis, and cancer pain.
    NIH is working with Federal partners to address research gaps for 
non-pharmacological treatments by providing the foundation for 
implementing these treatments into healthcare systems and leading 
ultimately to their broader dissemination. Through the HEAL 
initiative's PRISM (PRagmatic and Implementation Studies for the 
Management of Pain to Reduce Opioid Prescribing) program, NIH will 
support pragmatic clinical trials on how best to imbed effective non-
pharmacological treatments for pain into large healthcare settings. 
PRISM currently supports implementation trials to manage low back pain, 
fibromyalgia and post-operative pain.
    Question. Could you please provide Congress with the Department's 
timeline for developing these non-opioid alternatives?
    Answer. The timeline for developing a novel drug, from early stages 
to approval, can take many years. However, in considering the timeline 
for developing non-opioid alternatives, it is important to note that 
several potential drugs are already at various stages along the 
development pipeline in NIH and the private sector, including some 
industry-sponsored phase III clinical trials. Furthermore, drugs on the 
market for other conditions may prove effective as an opioid 
alternative for other specific pain conditions, and a variety of non- 
drug interventions are also at various stages of testing for pain. The 
HEAL Initiative is aggressively exploring all of these potential 
alternatives to make non-opioid options available as soon as possible.
                     headache disorders & migraine
    Question. Migraine is currently the second leading cause of all 
global disability. One in seven Americans will experience a migraine 
attack this year and cluster headache is widely reported to be the most 
severe pain that humans can experience.
    Unfortunately, due in part to limited research and treatment, 
inappropriate opioid prescriptions for migraine present Americans with 
ongoing risks of opioid use disorders and have worsened outcomes in 
patients. The NIH website on disease burden shows ``migraine'' to have 
received by far the lowest level of research funding in 2015, among 
those diseases with the highest burden. In 2017, only 53 extramural 
investigators were funded for headache research, compared to 315 for 
epilepsy and 385 for schizophrenia, each of which has far lower burden 
than migraine.
    In 2018, NIH announced the Helping to End Addiction Long-term 
(HEAL) initiative, a trans-agency effort to speed scientific solutions 
to stem the national opioid epidemic. While headache disorders and 
migraine grant proposals are eligible for consideration under the HEAL 
RFAs recently issued for pain research, I am very concerned that these 
will fail to attract enough investigators to this historically under-
funded research area.
    Does NIH have plans to issue specific RFA programs for headache 
disorders and migraine research, comparable in scope to the BACPAC 
group of RFAs for research on back pain?
    Answer. All HEAL solicitations called for research on any pain 
conditions including headache, and many specifically called for 
headache research. The few exceptions were targeted RFAs for low back 
pain and hemodialysis pain. Both of these pain conditions differ from 
headache disorders in that they are associated with high rates of 
opioid prescribing and lack essential research resources to move their 
fields forward. While opioids are sometimes used for chronic headaches 
and acute headaches in emergency room settings, prescribing rates are 
curbed by practice guidelines that recommend not using opioids in 
either situation. The NIH HEAL BACPAC program was established to meet 
objectives, not only to reduce reliance on opioids, but also to address 
the lack of essential research resources for low back pain, such as 
accurate diagnostic tools, meaningful clinical endpoints and case 
definitions needed to advance quality research. These research 
essentials for headache disorders are established, in part through NIH 
support, and widely accepted by the research community.
    An important HEAL objective is to improve pain management, and NIH 
recognizes that advancing headache research is needed to improve care. 
Therefore, the NIH staff aggressively promoted HEAL RFAs inclusive of 
all pain conditions to inform the headache research community of these 
opportunities. HEAL proposals for headache research were awarded to: 
(1) understand trigeminal nerve circuitry which is the nervous system 
component that underlies headache disorders, (2) discover markers that 
predict persistent headache after head trauma, (3) explore how 
dysfunction of an ion channel called TRESK mediates headache trigeminal 
pain and predisposes women to migraines, (4) explore the therapeutic 
potential of TRP channels for orofacial pain, and (5) study a novel 
CGRP receptor, AMY1, that mediates migraine induced behaviors. Many 
other compounds are being developed and tested as safe analgesics for a 
broad spectrum of chronic pain conditions, which might also be helpful 
in relieving headache and other trigeminal pain. In addition to the 
HEAL initiative, many NIH Institutes and Centers support initiatives 
whose scope includes headache disorders for a broad range of research, 
from neural mechanisms that cause headache, to development of 
treatments, to dissemination of effective therapies into the clinic. 
NIH continues to solicit research on pain mechanisms and pain 
management and has established communication channels to ensure that 
the headache research community is up to date on funding opportunities.
    Question. How many HEAL RFAs related to headache disorders and 
migraine grant proposal have been submitted since the launch of NIH's 
HEAL initiative? How many of those grant proposals have been awarded?
    Answer. Research on headache disorders, including migraine, is 
within the scope of research solicited by all prior and current HEAL 
RFAs for preclinical and clinical pain research, other than those for 
BACPAC and hemodialysis pain. For example, HEAL priorities include 
enhanced understanding of pain, discovery and validation of novel pain 
targets, testing therapies in clinical settings, and accelerating 
development of better therapies for patients. HEAL funding opportunity 
announcements relevant to pain and pain management called for research 
on all pain conditions and for a broad range of research proposals 
including biomarker discovery, analgesic device and drug optimization 
clinical trials to compare effectiveness of interventions, and studies, 
to determine how to bring effective therapies into real world 
healthcare settings. Headache research is within the scope of all these 
solicitations, and NIH engaged with the headache research community to 
inform them of such research opportunities and encouraged them to 
submit applications. HEAL proposals in headache research were awarded 
to: (1) understand trigeminal nerve circuitry which is the nervous 
system component that underlies headache disorders, (2) discover 
markers that predict persistent headache after head trauma, (3) explore 
how dysfunction of an ion channel called TRESK mediates headache 
trigeminal pain and predisposes women to migraines, (4) explore the 
therapeutic potential of TRP channels for orofacial pain, and (5) study 
a novel CGRP receptor, AMY1, that mediates migraine induced behaviors. 
Many other compounds are being developed and tested as safe analgesics 
for a broad spectrum of chronic pain conditions, which might also be 
helpful in relieving headache and other trigeminal pain. These awards 
will contribute to gap areas in headache research.
                                medicaid
    Question. The Department's fiscal year 2021 budget proposes to cut 
Medicaid by $920 billion over the next 10 years. The budget also 
proposes to overhaul the program into block grants and caps that would 
restrict States' abilities to respond to public health issues such as 
the opioid epidemic. Vermont, for example, has been able to utilize 
Medicaid to help create their Hub and Spoke approach to combat opioid 
addiction, which has become a national model in the fight against 
opioid misuse and addiction. Additionally, the administration's 
Medicaid block grant proposal includes vague guidelines on how the 
Federal matching dollars can be spent.
    How will these proposed cuts to Medicaid would help States such as 
Vermont be more responsive to public health issues that require 
increased health investments such as the opioid epidemic or 
coronavirus?
    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 President's Budget increases funding for the opioid and meth 
epidemic by $5.2 billion, an increase of $169 million or +3 percent, 
above fiscal year 2020 to combat the opioids and meth crisis. In 2018, 
overdose deaths declined for the first time since 1990, falling by 5 
percent and ending 3 decades of increases. HHS continues the fight 
against opioid addiction and is using our 5-part strategy to halt a 
rise in meth and other stimulants use.
    Question. How will the administration's Medicaid block grant 
proposal ensure continued access to health insurance and health 
services for the millions of Americans who obtained health insurance 
coverage under the Affordable Care Act's Medicaid expansion provision?
    Answer. 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.
    Question. What guardrails does the administration plan to put in 
place to ensure that the Federal matching dollars within the Medicaid 
block grant proposal are spent on health matters and not unrelated 
States priorities?
    Answer. Please see page 20 of the HAO SMD, if the State achieves 
certain performance metrics and spends less than its projected 
spending: After CMS determines that a State has qualified for shared 
savings under the demonstration, we anticipate exercising expenditure 
authority for reinvestment during the State's next demonstration year 
in programs which could include matching State expenditures up to a 
percentage for existing State-funded health programs that have not 
previously qualified for Federal funding (limited to 30 percent of the 
total amount eligible for shared savings reinvestment) or for new 
health-related initiatives targeting the demonstration population or 
other Medicaid beneficiaries that would not otherwise be eligible for 
matching funds under the State plan or another demonstration. Examples 
of initiatives that could be funded with matching funds through shared 
savings include providing Medicaid services for populations not 
currently covered by the State's State plan or another demonstration, 
such as supported work or service coordination; paying for services not 
included in the State plan or another demonstration for Medicaid 
beneficiaries, such as pre-vocational services; initiatives designed to 
improve the quality of and access to care provided to Medicaid 
beneficiaries; and allowable benefits and services designed to address 
certain social determinants of health. For programs or initiatives 
funded through shared savings to be eligible, CMS will need to 
determine that they will be likely to promote the objectives of the 
Medicaid program. Any shared savings for which a State may be eligible 
based on its performance in a particular demonstration year would be 
expected to be available to States for the next 3 years only, including 
into a new demonstration period if the 3-year period extends into a new 
demonstration period and CMS has approved a demonstration renewal. 
Shared savings should not be used to supplant or duplicate other 
Federal funding. In some cases, States may seek to use a portion of the 
shared savings expenditure authority to invest in existing State-funded 
programs. For example, the State may be operating State-funded tobacco 
cessation program that supports many Medicaid beneficiaries. Earning 
Federal share for investing in this program would free existing State 
resources that States could choose to reinvest in expanded services or 
benefits for other Medicaid enrollees, including mandatory State plan 
populations not covered under this demonstration.
    Question. Could you please explain how the Medicaid block grant 
proposal will expand patient access to health insurance coverage?
    Answer. As noted in the response above, States may seek to use a 
specified portion of any achieved shared savings expenditure authority 
to invest in existing State-funded programs. For example, the State may 
be operating a State-funded tobacco cessation program that supports 
many Medicaid beneficiaries. Earning Federal share for investing in 
this program would free existing State resources that States could 
choose to reinvest in expanded services or benefits for other Medicaid 
enrollees, including mandatory state plan populations not covered under 
this demonstration.
               low income home energy assistance program
    Question. The Low Income Home Energy Assistance Program (LIHEAP) 
provides essential assistance to Americans to heat or cool their homes. 
This is especially important in Vermont. It is extremely disappointing 
that the administration's budget again proposes the elimination of 
LIHEAP. Furthermore, the administration's proposal to remove funding 
from LIHEAP to support the coronavirus is shortsighted because of the 
very real immediate health consequences of home heating and cooling.
    This program provides benefits across the county, including to over 
20,000 households in Vermont. In cold weather States, home heating 
costs can be exceptionally high and LIHEAP benefits are often 
insufficient. Vermont families often expend their full annual benefits 
early in the heating season and depend on emergency funds to heat their 
homes for the remainder of the season. I am concerned that it took over 
2 months for the administration to allocate the remaining 10 percent of 
fiscal year 2020 LIHEAP funding.
    How can you more efficiently and expeditiously allocate final 
LIHEAP funding, should the government find itself receiving full year 
funding through a spending bill following a continuing resolution?
    Answer. HHS and the Office of Management and Budget (OMB) have 
worked in partnership for a number of years to ensure that LIHEAP 
receives as much of its funding as possible as early as possible in the 
fiscal year, as opposed to following a more typical quarterly 
allocation process.
    Whenever LIHEAP is subject to a continuing resolution, HHS has 
historically requested, and OMB has concurred, with releasing 90 
percent of the funding in the early fall. Absent a final appropriation, 
HHS is unable to issue 100 percent of LIHEAP funding without 
jeopardizing Congress' final funding prerogative or burdening grantees 
with returning funding that they may have already made legal 
commitments against.
    Even with receiving funding in October, grantees still make many 
program decisions prior to receipt of Federal funding in order to ramp 
up the start of their heating or year-round programs in the fall. This 
includes outreach activities, mailing applications to prior year 
recipients (particularly vulnerable households on fixed incomes), 
entering into agreements with subgrantees to prepare intake services, 
etc.
    For fiscal year 2020, HHS released 90 percent of LIHEAP funds 
available under the Continuing Resolution in November of 2019. 
Additional funds were released in February of 2020, after passage of 
the full year appropriation. All remaining LIHEAP funds provided by the 
full year appropriation have been released. Funds origionally 
transferred from LIHEAP for COVID-19 response were returned to LIHEAP 
and released per the requirements of the Coronavirus Preparedness and 
Response Supplemental Appropriations Act, 2020 (Public Law 116-123).
    Question. As the administration continuously--and cruelly--proposes 
elimination of the LIHEAP program, what would you say to the thousands 
of American families who rely on this assistance every year? Do you 
think they are just simply out of luck?
    Answer. LIHEAP does not require grantees to report on outcome 
metrics and the program is, therefore, unable to demonstrate strong 
performance outcomes, such as improved self-sufficiency. In addition, 
many State and local governments now provide significant heating and 
cooling assistance and the majority of States prohibit utilities from 
discontinuing heating during the winter months. With our limited 
resources and based on the review of local policies, we determined that 
continued funding of the LIHEAP program is not the best use of taxpayer 
dollars and have proposed eliminating future funding for this program.

                          SUBCOMMITTEE RECESS

    Senator Blunt. The committee will stand in recess.
    [Whereupon, at 12:37 p.m., Tuesday, February 25, the 
subcommittee was recessed, to reconvene subject to the call of 
the Chair.]