[Senate Hearing 115-277]
[From the U.S. Government Publishing Office]



 
  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2019

                              ----------                              


                         THURSDAY, MAY 10, 2018

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 10:04 a.m. in room SD-124, Dirksen 
Senate Office Building, Hon. Roy Blunt (chairman) presiding.
    Present: Senators Blunt, Alexander, Moran, Capito, 
Lankford, Kennedy, Rubio, Hyde-Smith, Murray, Durbin, Shaheen, 
Merkley, Schatz, Baldwin, Murphy, and Manchin.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                        Office of the Secretary

STATEMENT OF THE 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.
    I'm certainly pleased, Secretary Azar, to have you here 
this morning. I'm sure we're going to have a number of 
questions about your budget, and I'd preface that by saying 
that we understand that the final congressional action and 
Administration action on fiscal year 2018 occurred after you 
were asked to submit your budget. Still, there are things we 
need to talk about.
    The actual budget you submitted was $1.9 billion or 2.1 
percent lower than the bill we just passed. And then in 
addition to that there's another $5.6 billion that shifts from 
the mandatory side to the discretionary side in your budget. I 
think when you add all this up, the budget is actually more 
like 16 percent lower than the budget we just voted on, and I'm 
sure we're going to talk about that and look at that.
    The budget request had to be submitted when it had to be 
submitted. But throughout the bill, looking at some of our 
priorities--medical research, early childhood education, the 
preparedness programs--are programs there will be questions on. 
I certainly agree that we ought to look everywhere we can for 
savings. We should look for programs that aren't working and 
make that decision that this is just an idea that wasn't 
necessarily a bad idea, but it didn't work; look for programs 
that we can combine to where we eliminate both redundancy and 
administrative cost, but at the same time the committee will 
want to be heard on what we think should happen.
    Senator Murray and I worked hard to craft a bill for your 
department this year that I think reflected the priorities of 
our members, of the Department itself, and the Administration. 
We provided a $3 billion increase for the National Institutes 
of Health, and over the past 3 years we've increased NIH 
(National Institutes of Health) research, that budget, by 23 
percent. We'll have Dr. Collins in, in a few days, to talk 
about that.
    I also, Mr. Secretary, understand there are some questions 
from OMB about the way we believe that money should be spent, 
and we'll be insisting on the way we believe that money should 
be spent. The President agreed to this budget. Management from 
OMB is one thing. Trying to decide what the congressional 
priorities should be from OMB would be another thing.
    We're committed and will remain committed, along with you, 
to addressing the opioid epidemic. Opioids have passed car 
accidents as the number-one cause of accidental death in the 
country. That budget was increased by $2.55 billion, a 244 
percent increase. At some point I think we want to look pretty 
carefully and be sure we're not increasing that budget faster 
than the money can reasonably be spent, but a lot of that 
increase, a little over half of that increase, $1.5 billion, is 
flexible funding for the states, and I would also think that 
right now is a good time to let the states help us figure out 
what works and what doesn't work, and where it works and where 
it may not work. It's a great advantage of our system, and this 
is a crisis that needs to be dealt with quickly but needs to be 
dealt with in a way that allows states to try as many things as 
they think might work.
    I know in Missouri we're doing the medication first 
approach, combined with counseling. Other states are doing 
that, and other states are looking at this in a different way. 
But that flexibility, I think, at least initially, is going to 
be very important, and it may turn out to be very important 
throughout this crisis because it's a big country with lots of 
different issues to be addressed.
    I think it's important, and our committee has gone on 
record thinking it's important, to treat mental health just 
like we treat any other health problem. I think as those issues 
are coupled with opioid dependency, the mental health efforts 
are clearly an integral part of whether we are successful in 
the opioid issue, but they're also, I think, critically 
important as we look to overall health.
    We have made a big increase in mental health funding in the 
omnibus. In fact, it was $306 million; $160 million of that 
increase went to the mental health block grant, and another 
$100 million went to a new program targeted at certified 
community behavioral health clinics. I'm pleased that both the 
medical research and funding to combat the opioid epidemic were 
reflected in your budget, but I was disappointed that we didn't 
see as strong a commitment in your budget as we just made in 
our spending bill.
    I'm also concerned about the proposed elimination of LIHEAP 
(Low Income Home Energy Assistance Program), which is the 
heating/air conditioning assistance program. The children's 
hospital graduate medical education, I actually don't know 
where that money is supposed to come from if it doesn't come 
from discretionary. I'd like to figure out a way that graduate 
medical education for children's hospitals has a dedicated 
source, just like all other graduate medical education has. 
Zeroing it out would not be the way to solve that problem 
unless you've got a better replacement, and I'd like to see a 
permanent replacement.
    Also, I have concerns that some of the health workforce 
programs are not as supported in this budget as I think they 
will be in a product that comes out of this committee.
    But you have a big job. We appreciate the job you do. I 
personally appreciate the great expertise you bring to it, 
having been in the Department before, having worked in this 
area for so long, and I appreciate that. But our job is to work 
together to try to make what we do better, and I'm pleased to 
get to work with Senator Murray as we do that.
    [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 2019 budget request. This is your first time 
testifying before this Subcommittee and we look forward to hearing your 
testimony.
    The fiscal year 2019 discretionary budget request for the 
Department is $1.9 billion, or 2.1 percent, lower than the Omnibus 
passed in March. However, the request includes shifting nearly $5.6 
billion in funding from the mandatory side of the budget to the 
discretionary side, and provides $10 billion in multi-year funding for 
opioids, of which $7 billion is unallocated. Adjusting for these to 
make an apples-to-apples comparison, the request for the Department is 
$14 billion, or 16 percent, lower than fiscal year 2018. These 
decisions artificially inflate the budget request and forced you to 
significantly cut or eliminate programs unnecessarily.
    While this budget request is an improvement over the one we 
received last year, it still had you making difficult decisions and 
balancing competing priorities throughout the bill--from medical 
research, to early childhood care and education, to preparedness 
programs. In addition, you had to submit your request for fiscal year 
2019 before Congress had finished its work on the fiscal year 2018 
bill. That required many decisions before you knew which programs 
Congress would set as priorities.
    I agree that there are many places in the Department's budget we 
should look to for savings. You bring a fresh perspective to the HHS 
budget and I hope we can work together to identify programs that are 
ineffective or no longer needed and put that funding to better use 
elsewhere.
    The Omnibus that Senator Murray and I helped craft set the 
Department on a strong path forward for this year. We worked very hard 
to ensure that it reflected the priorities of our Members, the 
Department and this Administration, and the best needs of the country. 
Importantly, it provided significant investment to three of my 
priorities.
    First, the Omnibus provided a $3 billion increase for the National 
Institutes of Health. Over the last 3 years I have been Chairman, we 
have provided a 23 percent increase for medical research. This is 
particularly important because without Federal investment, we would not 
be able to continue to make progress on life-saving treatments and 
cures that affect millions of Americans.
    Second, I remain committed to addressing the opioid epidemic. Many 
families across the country never thought they would need to worry 
about someone they love overdosing on opioids just 10 years ago. Now, 
opioid overdoses surpass motor vehicle accidents as the number one 
accidental death in the country. The Omnibus provided an increase of 
$2.55 billion, or 244 percent, for health programs focused on opioid 
abuse. In particular, it provided $1.5 billion in flexible funding for 
States, focused funding on States with the highest mortality rate 
related to opioid use disorders, improved surveillance efforts in all 
50 States, and targeted funding towards rural communities that are 
hardest hit by this epidemic. I hope that with your leadership, the 
Department will allocate funding quickly so that States and communities 
can continue their efforts to address the crisis.
    Finally, it is important to address mental health as we would any 
other physical condition. Nearly one in five American adults suffer 
from a diagnosable mental disorder and less than half of adults with 
any mental illness receive mental health treatment. This is 
particularly critical now that mental health issues are often coupled 
with an opioid use disorder, making these individuals more likely to 
use drugs than those not affected. As Chairman of this Subcommittee, we 
increased funding for mental health programs by $306 million in the 
Omnibus, including $160 million for the Mental Health Block Grant and 
$100 million for a new program targeted at Certified Community 
Behavioral Health Clinics whose sole focus is to expand access to 
comprehensive mental health services.
    I was pleased that both medical research and funding to combat the 
opioid epidemic were reflected in your budget request. I understand you 
had to make tough choices, but was disappointed there was not a 
stronger commitment to mental healthcare which I understand is a 
priority of yours as well. I am also concerned about the eliminations 
of LIHEAP (pronounced lie-heap), Children's Hospitals Graduate Medical 
Education, and the majority of the health workforce training programs. 
While I understand difficult choices had to be made, I believe it's 
unlikely this Subcommittee will support these eliminations.
    However, I think you submitted a budget that is a good place to 
begin negotiations. My goal is for us to work together to identify 
priorities and find common ground while responsibly allocating 
taxpayers' resources.
    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, if you have some opening 
comments, we'll turn to those right now.

                   STATEMENT OF SENATOR PATTY MURRAY

    Senator Murray. All right. Well, thank you very much, 
Chairman Blunt.
    Welcome, Secretary Azar. Glad to see you back and recovered 
and with us today.
    I'm interested to hear your testimony about the 
Department's fiscal year 2019 budget request, though I have to 
tell you there are a lot of things in it that concern me. While 
I know you were not part of this administration when they 
started working on this budget request, you have made it clear 
that you do plan to continue some of the alarming ideological 
approaches this administration has taken since day one.
    A budget isn't just a set of numbers. It's actually a 
statement of values and priorities, and this budget seems to 
have been written by an administration that believes the goal 
of the Department of Health and Human Services is to raise 
families' healthcare costs and undermine patients' access to 
care, and it is not. It's clear instead of fighting to make our 
healthcare system stronger, instead of prioritizing ways to 
make it more affordable or accessible or effective for our 
families and patients, this administration is continuing to 
prioritize healthcare sabotage.
    It's clear instead of proposing solutions to make sure 
everyone can get the healthcare they need regardless of their 
background or a preexisting condition, this administration will 
continue to put in place policies that weaken patients' 
protections, take coverage away from people, and put their 
needed healthcare further out of their reach.
    And this budget does take an alarming step backwards when 
it comes to women's healthcare, continuing a much larger trend 
we've seen from the Trump-Pence Administration. Time after 
time, the Trump-Pence approach has put ideology over women's 
health and reproductive freedom, like the recent moves to 
undermine the Title X family planning program and the 
healthcare providers that offer very important services to 
women across the country who might not get the care they need 
otherwise.
    And then I'm very concerned about the way you've handled 
the Teen Pregnancy Prevention Program, terminating grants in 
the middle of a 5-year cycle, a decision that was made with 
little rationale and apparently at the direction of political 
appointees against the advice of career staff, and 
significantly changing the focus of that program to promote a 
single ideological approach, a decision which is contrary to 
congressional intent, which is to support, and I quote, 
``programs that have been proven effective through rigorous 
evaluation.''
    Page after page of this budget request raises new red 
flags: proposals to cut CDC (Centers for Disease Control and 
Prevention) by over $2 billion, which would devastate the 
agency's crucial work to promote immunizations, combatting 
emerging infections, preventing chronic disease, and keeping 
our communities healthy.
    The budget eliminates safety net programs and critical 
assistance to millions of people, like the LIHEAP program the 
Chairman mentioned, and the Community Service Block Grant, 
which gives States resources to address the challenges of 
poverty.
    It eliminates the Social Services Block Grant and reduces 
Temporary Assistance for Needy Families, programs that help 
families face adversity and keep their heads above water.
    It cuts $975 million from the Health Resources and Services 
Administration workforce programs, which support training for 
every type of healthcare provider.
    It eliminates funding for Preschool Development Grants, 
which we recently authorized and funded on a bipartisan basis 
to provide high-quality preschool to tens of thousands of 
families.
    So this is not the budget of an administration that values 
fighting to keep our communities healthy. It's not the budget 
of an administration that values evidence, science, and good 
policy-making practice. And it is actually not the direction 
this committee chose to take in our recent bipartisan spending 
bill.
    As you know, that 2-year bipartisan budget agreement we 
reached in February provided major new investments to address 
the opioid crisis, childcare and early learning needs, and 
more. We now hear that the Administration is going to submit a 
second rescission package and undo many of these investments. I 
want to make it clear today that we will vigorously oppose any 
effort to undo the bipartisan deal the President signed into 
law. Both sides made a commitment to that deal. Our side didn't 
get everything we wanted, and neither did the Republicans, but 
a deal is a deal. Any attempt by the Administration to break 
its promise by rescinding or failing to spend the omnibus 
funding would be a major breach of faith.
    So, in addition to asking about your budget request, I'm 
very interested in hearing how you plan to implement the 
funding increases we did include in the omnibus, especially in 
responding to the opioid crisis and childcare. I was glad to 
see your budget at least maintains the level of funding 
Congress directed the Administration to spend, $10 billion in 
multi-year funding, for activities related to the opioid 
crisis. Of that amount, you're proposing to allocate $2.8 
billion in 2019 to agencies funded within the bill.
    As you know, Chairman Blunt and I agreed to increase 
funding for the Childcare and Development Block Grant by over 
$2.3 billion, almost double what we spend now, to help improve 
childcare options for struggling families, and agreed to 
increase Head Start by over $600 million. I have heard from 
families in Washington State and around the country about their 
struggle to find and afford quality childcare, so I'm really 
glad we were able to take a step in the right direction, and I 
hope we can keep working to increase investments in childcare 
and early learning so every parent can afford childcare and 
every child is prepared to succeed in kindergarten and beyond.
    It's not only the right thing to do, it is a smart 
investment for families, communities, and our economy. It is 
one of the many urgent issues facing our families that 
Democrats and Republicans should be able to come together to 
address, like the alarmingly high maternal mortality rate, or 
the epidemic of gun violence and the lack of research into this 
issue which you yourself, Mr. Secretary, has said is a 
priority.
    And Democrats are going to keep making the case that we 
should take steps to actually help families address these 
problems instead of proposing cuts that do the opposite. And we 
will keep urging Republicans to work with us to make that 
happen.
    So, Mr. Secretary, I look forward to hearing what you have 
to say on these issues and discussing my concerns further 
during the questions and answers.
    Thank you very much, Mr. Chairman.
    Senator Blunt. Thank you, Senator Murray.
    As I've said already today, Secretary Azar, we're pleased 
that you bring your skills and your dedication in this area to 
the job you're doing, and you've done a lot of things that 
other people would not have been able to accomplish even in the 
last few months. We're glad you're here and look forward to 
your testimony.

                  SUMMARY STATEMENT OF HON. ALEX AZAR

    Secretary Azar. Chairman Blunt and Ranking Member Murray, 
and members of the committee, thank you very much for inviting 
me to discuss the President's budget for the Department of 
Health and Human Services for fiscal year 2019, and also my 
personal thanks for being willing to reschedule in light of my 
recent illness. Thank you for that accommodation.
    It's an honor to be here, and it's an honor to serve as the 
Secretary of HHS (Health and Human Services). Our mission is to 
enhance and protect the health and well-being of all Americans. 
It's a vital mission, and the President's budget clearly 
recognizes that.
    The budget makes significant strategic investments in HHS' 
work. Among other targeted investments, the budget requests 
$34.8 billion for the National Institutes of Health, $5.8 
billion for the Food and Drug Administration, and $2.8 billion 
for priority bio-defense and emergency preparedness programs.
    The President's budget especially supports four particular 
priorities that we've laid out for the Department, issues that 
the men and women of HHS are hard at work on already: first, 
fighting the opioid crisis; second, increasing the 
affordability and accessibility of health insurance; third, 
tackling the high price of prescription drugs; and fourth, 
transforming our healthcare system into a value-based 
direction.
    In addition, it strongly supports the ongoing work HHS does 
to keep Americans safe from natural disasters and infectious 
diseases.
    First, the President's budget brings a new level of 
commitment to fighting the crisis of opioid addiction and 
overdose that is stealing more than 100 American lives from us 
every single day. Under President Trump, HHS has already 
disbursed unprecedented resources to support access to 
addiction treatment. This budget would invest $3.5 billion in 
fiscal year 2019 to further address the opioid epidemic and 
serious mental illness. Within that allocation, for example, 
the budget dedicates $1.2 billion to the State targeted 
response to the opioid crisis grants, and invests $150 million 
specifically to confront the crisis in high-risk rural 
communities. Recognizing that we need new tools and private-
sector innovation to defeat this epidemic, the budget proposes 
$500 million to continue the NIH public/private partnership to 
develop new addiction treatments and non-addictive approaches 
to pain management.
    The budget also supports programs that have a proven record 
of improving the lives of Americans who suffer from serious 
mental illness. We at HHS are pleased that Congress, including 
members of this committee, responded to the President's call 
for these investments, choosing to significantly boost HHS 
funding to confront the opioid crisis in the recent omnibus 
spending bill.
    The second priority I will highlight is our commitment to 
breaking down the skyrocketing cost of health insurance, 
especially in the individual market. The budget proposes an 
historic transfer of resources and authority from the Federal 
Government back to the States, empowering those who are closest 
to the people and who can best determine their needs, while 
also bringing balance to the Medicaid program.
    Third, prescription drug costs in our country are simply 
too high. List prices are too high. Seniors in government 
programs are overpaying due to lack of negotiating tools. Out-
of-pocket costs are too high, and foreign governments are 
freeloading off of our investments in innovation.
    To address these problems, the budget proposes a five-part 
reform plan to further improve the already successful Medicare 
Part D program by straightening out incentives that too often 
serve middlemen more than they do our seniors or the government 
program.
    The budget also proposes Medicaid and Medicare Part B 
reforms to save patients money on drugs and provide strong 
support for FDA's (Food and Drug Administration) efforts to 
spur innovation and competition in the generic drug market.
    We also want Medicare and Medicaid and our entire system to 
pay for health and outcomes rather than procedures and 
sickness. Our fourth departmental priority is to use the powers 
we have at HHS to drive value-based transformation throughout 
the entire healthcare system. This budget takes steps toward 
that shift, laying the groundwork for the value-based vision 
that I announced this spring. Our system may be working for 
entrenched incumbents, but it isn't working for patients or the 
taxpayer, and that has to change.
    Finally, I want to highlight this budget's investments in 
HHS efforts to keep Americans safe from a range of threats, 
from natural disasters to international infectious threats like 
Ebola and pandemic flu. The budget funds a continuation of the 
successful public/private partnership such as the Biomedical 
Advanced Research and Development Authority, which has already 
launched 35 FDA-approved products since its establishment in 
2006. The budget also provides U.S. support for the Global 
Health Security Agenda, an effort to build other countries' 
response capacity so we can prevent infectious threats from 
ever reaching our shores in the first place.
    The President's budget will make the programs we run really 
work for the people they are meant to serve, including by 
making healthcare more affordable for all Americans. It will 
make sure our programs are on a sound fiscal footing that will 
allow them to serve future generations too, and it will make 
the investments we need to keep Americans safe. Delivering on 
these goals, as the President's budget does, is a sound vision 
for the Department of Health and Human Services, and I'm proud 
to support it.
    Thank you, and I look forward to the committee's questions 
this morning.
    [The statement follows:]
               Prepared Statement of Hon. Alex M. Azar II
    The mission of the Department of Health and Human Services (HHS) is 
to enhance and protect the health and well-being of the American 
people.
    President Trump and all of us at HHS take that charge seriously. 
So, when programs are not as effective as they can be, or cost more 
than they ought to, or fail to deliver on their promise, change and 
reform are necessary.
    The President's fiscal year 2019 Budget applies this reform mindset 
to the work of the Department, making thoughtful and strategic 
investments to protect the health and well-being of the American 
people, while addressing the opioid crisis, promoting patient-centered 
healthcare, strengthening services for American Indians and Alaska 
Natives, encouraging innovation in America's healthcare future, 
addressing high drug prices, reforming the Department's regulations, 
and generally focusing resources toward proven and effective 
initiatives. The Budget also recognizes the fiscal challenges our 
country faces today, and the need to focus our investments and update 
them to meet the needs of a rapidly changing world.
    The President's Budget for HHS also reflects proposals to meet the 
President's comprehensive Government-wide Reform Plan through a 
Department initiative called ReImagine HHS. ReImagine HHS, through a 
range of initiatives, aims to identify opportunities to improve the 
work HHS does for the American people, in terms of its efficiency, 
quality, and cost-effectiveness. In particular, ReImagine HHS offers a 
unique opportunity for the experienced career staff of the Department 
to lead initiatives that will advance the work of the Department and 
revamp outdated processes and structures.
    Across all of HHS's priorities, the Budget makes clear that 
business-as-usual will not suffice, and that the substantial 
investments made every year at HHS ought to be allocated with 
efficiency and toward programs that work.
                      tackling the opioid epidemic
    One of the Department's top priorities is fighting the scourge of 
opioid addiction facing our country.
    Due to skyrocketing numbers of opioid overdoses, deaths by drug 
overdose have become the leading cause of injury death in the United 
States. In 2016, 174 Americans died each day from drug overdoses. 
American life expectancy has dropped for the second year in a row--a 
tragic development not seen in more than a half century.
    The President's Budget recognizes the devastation caused by this 
crisis in communities across America, by providing a historic new 
investment of $10 billion in HHS funding to address the opioid crisis 
and serious mental illness, and building upon the work started under 
the 21st Century Cures Act.
    The Budget's targeted investments advance the Department's five 
part strategy, which complements work being done elsewhere in the 
Administration and covers:
  --Access: Improving access to prevention, treatment, and recovery 
        services, including medication-assisted treatment;
  --Overdoses: Targeting availability and distribution of overdose-
        reversing drugs;
  --Data: Strengthening our understanding of the epidemic through 
        better public health data and reporting;
  --Research: Supporting cutting edge research on pain and addiction; 
        and
  --Pain: Advancing better practices for pain management.
    The Budget proposes to improve ways in which the Federal Government 
helps communities respond to the opioid epidemic. As just one example, 
the Budget directs resources to the Substance Abuse and Mental Health 
Services Administration to improve access to medication-assisted 
treatment services, boost State capacity to establish and operate 
comprehensive prevention systems, and disseminate high-quality 
resources on best practices for treatment.
    The Budget includes a total of $126 million to support efforts by 
the Centers for Disease Control and Prevention (CDC) to prevent the 
abuse and overdose of opioids. This investment supports key public 
health and surveillance activities at the State level, recognizing that 
States can best determine their unique needs. CDC will also continue to 
increase the awareness and adoption of the CDC Guideline for 
Prescribing Opioids for Chronic Pain. In all of these activities, CDC 
will endeavor to support and execute programs that have a proven track 
record of success.
    We recognize that government at the Federal, State, and local 
levels cannot defeat the opioid crisis alone, so HHS will continue to 
leverage the resources and expertise of the private sector and academia 
to develop new tools to end the epidemic. This includes a $500 million 
investment in a National Institutes of Health (NIH) public-private 
partnership to accelerate the development of new treatments for pain 
and addiction.
    To help address the drivers of the epidemic, current practices for 
pain management must also be rethought, including in the work of 
Federal agencies that prescribe painkillers. The fiscal year 2019 
Budget will support the Pain Management Best Practices Inter-Agency 
Task Force, which will determine whether there are gaps or 
inconsistencies in pain management best practices among Federal 
agencies; propose recommendations on addressing gaps or 
inconsistencies; provide the public with an opportunity to comment on 
any proposed recommendations; and develop a strategy for disseminating 
information about these best practices.
              effectively treating serious mental illness
    Serious mental illness, such as a psychotic or major depressive 
disorder, afflicts nearly 10 million American adults each year, and 
remains one of the Nation's most difficult healthcare challenges. 
Without treatment, many of these individuals cycle repeatedly among the 
health, behavioral health, and criminal or juvenile justice systems, 
with each system insufficiently prepared to meet their needs. According 
to one report, 10 times as many Americans with serious mental illness 
are in jail or prison than in inpatient psychiatric treatment, and 
tragically, Americans with serious mental illness live lives at least 
10 years shorter, on average, than others.
    The Budget recognizes that there are effective, proven forms of 
treatment for those struggling with serious mental illness, which have 
not always received the necessary support. One is ``assertive community 
treatment,'' which places individuals in the care of a 
multidisciplinary behavioral health staff to deliver comprehensive 
services and treatment and has been shown to reduce hospitalization and 
improve patient satisfaction compared with other interventions of the 
same cost. The Budget fully funds a new Assertive Community Treatment 
for Individuals with Serious Mental Illness program, authorized by the 
21st Century Cures Act.
    Another effective approach to serious mental illness is the 
Budget's support of Certified Community Behavioral Clinics, funded as 
part of the new $10 billion investment to address the opioid epidemic 
and serious mental illness. The Budget also continues to direct 10 
percent of State allocations from the Community Mental Health Services 
Block Grant to bring care more quickly to those experiencing a first 
episode of psychosis, a proven intervention.
                   advancing health reform that works
    A Washington-centric, one-size-fits-all approach to healthcare --
especially in insurance markets most affected by Obamacare--is simply 
not working and must change. The President's Budget proposes a bold 
plan to redirect a significant amount of healthcare funding back to the 
States and individuals, where healthcare decisions should be made, 
while also taking major steps to encourage innovation and better 
quality of care.
    The Budget supports repealing Obamacare and replacing the law with 
flexibility for States to create a free and open healthcare market 
tailored to their citizens' needs. The two-part approach is modeled 
closely after the Graham-Cassidy-Heller-Johnson amendment to H.R. 1628, 
the American Health Care Act of 2017, and also includes additional 
reforms to put healthcare spending on a sustainable fiscal path.
    The proposed Market-Based Health Care Grant Program will help 
States stabilize their insurance markets and provide for a smooth 
transition away from Obamacare. The Budget would also fix the perverse 
incentive structures created by Obamacare, by ending the disparity 
between States that expanded Medicaid to new populations and those that 
did not and providing States with a choice between a per capita cap and 
a block grant.
    The Budget also proposes reforming our broken medical liability 
system, to ensure it is not driving excess costs. Finally, the Budget 
proposes consolidating the byzantine system of graduate medical 
education funding into a single, direct grant program that will 
streamline incentives and better serve patients and providers.
Bringing Down Drug Prices
    As President Trump has repeatedly made clear, the prices Americans 
pay for prescription drugs are simply too high. The Budget proposes a 
range of legislative measures to build on the proven success of the 
Medicare Part D prescription drug program, including through giving 
drug plans more tools to negotiate with manufacturers and encourage use 
of higher value drugs.. In addition, the Budget discourages rebate and 
pricing strategies that increase spending for both beneficiaries and 
the Government and, for the first time in the program's history, 
provides beneficiaries with more predictable annual drug expenses 
through the creation of a new out-of-pocket spending cap for seniors 
with especially high drug costs.
Sustainable Medicaid and Medicare Reforms
    Millions of Americans rely on Medicaid and Medicare to meet their 
everyday healthcare needs. Together, Federal healthcare programs 
comprise the largest portion of the Federal budget. The President's 
Budget proposes several legislative solutions to improve the programs, 
promote greater efficiencies, advance patient-centered care, and reduce 
government-imposed burden on providers.
    The Administration recognizes that the over-50-year-old structure 
of the Medicaid program has failed to create a sustainable Federal-
State partnership that is capable of controlling costs. In fact, its 
outdated design incentivizes cost increases without delivering 
commensurate benefits or allowing for much-needed local health 
innovation.
    Our Budget proposes a new future for Medicaid that will restructure 
Medicaid financing, provide States with new flexibilities to better 
serve their communities, improve the State plan and waiver processes, 
and provide the right incentives to preserve the program for future 
generations.
                   boosting upward economic mobility
    There is no more effective anti-poverty program than helping 
someone find a job. Recognizing this common-sense approach, the 
President's Budget re-focuses HHS's public assistance programs on 
helping low-income Americans find gainful employment, providing them 
with a sense of purpose, personal dignity, and independence.
    Importantly, the Budget proposes key reforms to the Temporary 
Assistance for Needy Families program that reinforce its focus on 
promoting work as the best pathway to self-sufficiency. Specifically, 
the Budget strengthens the program's accountability framework related 
to work requirements and ensures that States allocate sufficient funds 
to work, education, and training activities.
    The Budget also proposes establishing Welfare to Work Projects that 
will allow States to streamline funding from multiple public assistance 
programs and redesign service delivery to meet their constituents' 
specific needs. Importantly, these Welfare to Work Projects would be 
rigorously evaluated, expanding the evidence base that informs how 
assistance programs can be most effectively structured to help 
Americans achieve self-sufficiency.
    In January, for the first time in the history of the Medicaid 
program, the Federal Government indicated openness to State-led 
innovations that promote work or community engagement activities for 
working age, able-bodied enrollees. Productive work and community 
engagement is associated with improved health and well-being, meaning 
this reform can achieve the goals of the Medicaid program while also 
supporting independence and economic self-sufficiency for millions of 
able-bodied adults.
         promoting efficiency and innovation in scientific work
    Supporting and encouraging scientific research is a longstanding 
Federal priority, one that results in both a growing economy and longer 
lives. Executing this responsibility demands that the Federal 
Government regularly consider how to organize such support in the most 
efficient manner possible.
    The administration believes it is a priority to support NIH, a 
crown jewel of American science, and proposes to do so not just through 
continued financial investments but also through innovative 
partnerships with non-Federal entities, administrative reforms, and 
better coordination and planning.
    Among other efforts to derive maximum benefit from the substantial 
Federal investments made in NIH research, the Budget supports expanding 
public-private partnerships that will challenge private sector partners 
to match Federal investments; increasing coordination across NIH's 
Institutes and Centers; focusing grant awards on projects with the 
highest potential to accrue benefits for public health; assessing new 
and current strategic investments in research; curtailing the rate at 
which high researcher salaries at private institutions are reimbursed 
with taxpayer dollars; and implementing burden reduction measures to 
reduce costs for grant recipients.
    The Budget also supports administrative reforms for NIH, including 
efforts to harmonize operational functions and break down silos within 
the agency. In addition, the Budget proposes to consolidate three other 
major HHS research institutions in NIH to maximize the effectiveness of 
their research.
    The Food and Drug Administration (FDA) is another crown jewel of 
American science. But its needs and priorities must change as the face 
of medical innovation changes, too. The Budget includes investments for 
FDA to speed the development and approval of new drugs and medical 
devices, and to increase the quality and safety of next generation 
manufacturing practices, including approximately $500 million to 
strengthen medical product safety development and access.
            investing in our biodefense, preparedness, and 
                    global health security programs
    The President's Budget aims to improve our Nation's preparedness 
for, and capabilities to respond to, chemical, biological, 
radiological, and nuclear threats; pandemic influenza; natural 
disasters; emerging infectious diseases; and cybersecurity challenges.
    In each area, smart investments that empower the private sector and 
our global partners will help keep our country safe.
Chemical, Biological, Radiological, and Nuclear Threat Preparedness
    The Budget includes $512 million for the Biomedical Advanced 
Research and Development Authority (BARDA) and $510 million for Project 
BioShield, which fund successful public-private partnerships that 
support the development and procurement of new medical products crucial 
to defending our country against chemical, biological, radiological, 
nuclear, and infectious disease threats. Prior HHS investments in these 
programs have resulted in more than 190 medical countermeasure 
candidates, 34 FDA-approved products from BARDA, and the procurement of 
14 new products for the Strategic National Stockpile. Funding will also 
be available for exercises to build preparedness for threats such as 
emerging infectious diseases, natural disasters, and manmade 
biological, chemical, nuclear, and radiation threats
    The Budget proposes to transfer the Strategic National Stockpile to 
the Office of the Assistant Secretary for Preparedness and Response, to 
boost operational efficiencies and streamline development and 
procurement of medical countermeasures. It also provides $575 million 
to maintain and replenish the stockpile, the Nation's largest supply of 
life-saving medical countermeasures that can be deployed in the event 
of a public health emergency. .
Natural Disaster Preparedness
    Following the powerful hurricanes and historic wildfires of 2017, 
HHS remains ready to respond to any and all hazards when disaster 
strikes. The Budget ensures the Department is able to support essential 
emergency preparedness activities to refine our disaster responses. In 
particular, Hospital Preparedness Program resources will continue to be 
allocated to States and localities according to risk, ensuring 
communities with more risk have the necessary coordination and 
resources. The Budget also continues to provide $50 million to support 
the National Disaster Medical System. Through this cost-effective and 
successful program, HHS trains and deploys teams of American healthcare 
professionals from across the country to provide medical care to our 
fellow Americans in the event of an emergency.
Global Health Security
    One of the most effective ways to protect Americans from the threat 
of infectious diseases is to enable other countries to follow through 
on their own commitments to contain and respond to disease threats. 
Such investments are far less expensive than mounting an international 
public health response to control an epidemic.
    To support this goal, the Budget provides a total of $409 million 
for CDC's global health activities, which strengthens CDC's 
international preparedness and response capabilities. The Budget would 
also build on substantial progress that has been made toward global 
health security goals under the Global Health Security Agenda (GHSA), 
including a $59 million investment that provides funding for CDC to 
continue this work into fiscal year 2020.
Cybersecurity
    The Budget recognizes that HHS must continue robust operations to 
meet today's cybersecurity needs and includes $68 million to ensure the 
Department is able to protect sensitive and critical information in an 
ever-changing threat landscape. The Department will also focus on 
support for and coordination with the healthcare and public health 
sectors in close coordination with the Department of Homeland Security, 
to promote information and resource sharing across levels of government 
and the private sector.
                strengthening the indian health service
    Through the Indian Health Service (IHS), HHS is responsible for 
providing quality healthcare services to more than 2.2 million eligible 
American Indians and Alaska Natives. The Budget prioritizes funding for 
this agency, and in particular for direct health services. The Budget 
also makes significant investments to assist IHS facilities with 
meeting CMS quality health standards.
    Looking forward, and consistent with our statutory authorities, we 
recognize that how we provide quality healthcare in Indian Country and 
beyond must change to achieve and ensure the high quality of these 
services. More Tribes have assumed the responsibilities of providing 
healthcare for their members with support from the IHS, and investments 
in the Budget reflect our support for the growth of tribal self-
governance in the provision of healthcare.
                              *  *  *  *  *
    The President's 2019 Budget for HHS recognizes the importance of 
focusing government spending on programs that work and reforming our 
Nation's healthcare programs for a fast-changing world. This Budget 
recognizes that securing America's future demands sound fiscal 
management and responsible decisions about our priorities. If we are 
serious about fulfilling HHS's mission of enhancing and protecting the 
well-being of all Americans, we must adopt the bold innovation and 
direction espoused by the President's Budget.

                             PHARMACY COSTS

    Senator Blunt. Well, thank you, Secretary.
    We'll have time for a second round of questions. Other 
members will come later. So, as much as possible, let's try to 
stay within 5 minutes on our first round, and if you have more 
questions and want to stay, that would be great. And if you 
have more questions you want to submit for the record that 
would be acceptable as well.
    Let's just start with pharmacy costs. You mentioned some 
key principles there. I know the Administration is going to 
have a major announcement tomorrow. Can you put a little more 
detail on the points that you've already made today, how those 
could be used, Medicare Part D and otherwise, the middleman 
issue? Anything you want to explain to us further there would 
be helpful.
    Secretary Azar. You bet. Thank you, Mr. Chairman. What we 
want to do is, of course, we want to balance the need to 
support innovation and the development, as this committee is 
very committed to, of the next generation of therapies for our 
people and the people of the world, but we want to balance that 
with access for patients, and very importantly, we want to make 
sure those prescription drugs are affordable.
    On that affordability front, we're trying to address four 
key problems. The first is list prices. Every incentive in the 
system is towards higher list prices. How might we help reverse 
the incentives on list prices?
    The second is ensuring that our programs are up to date in 
ensuring that we get the best deal possible for these drugs, so 
negotiating the best deals possible and ensuring our programs 
have those tools.
    The third is ensuring that there's adequate competition. At 
the end of the day, multiple products, multiple generics, 
multiple branded products, swift entry of generics, ending any 
kind of patent gaming that prevents generic entry is critical 
to long-term price reduction in our system.
    And then the fourth area is our patients' out-of-pocket 
expenses. As we've seen changes and transformations in 
insurance design over the last decade, patients are being asked 
to assume more of the cost of drugs when they show up at the 
pharmacy or get the bill at the hospital or doctor's office for 
those drugs, and how do we address that out-of-pocket.
    So those are the areas we're going to be focused on 
tomorrow when the President rolls out his game plan.
    Senator Blunt. I would say on the list price versus the net 
price issue, that whatever we do here needs to always also keep 
in mind people who aren't on any government program, people 
who, for whatever reason, haven't been able to afford or have 
chosen not to have an insurance plan that they thought didn't 
meet their needs. They're the ones who, more often than not, at 
least initially, are asked to pay the list price that virtually 
nobody else is paying, and we need to be sure we're aware of 
that at the same time.

                       DURABLE MEDICAL EQUIPMENT

    On durable medical equipment, Mr. Secretary, you've been 
forward leaning in trying to help solve that problem. In our 
State, in Missouri, there are a lot of urban Missourians, 
suburban Missourians who live in communities that have lots of 
options. They can shop. There's competition. There are lots of 
Missourians that don't have that at all, and I think in June of 
2013 we had 199 suppliers of durable medical equipment, many of 
them the only suppliers in rural communities. We're down now to 
152.
    I think the Office of Management and Budget just released a 
rule that you sent them last year. What will that do to 
encourage people to continue to provide the kind of medical 
equipment that allows people to stay at home rather than their 
other option, which is much more expensive for taxpayers in 
most cases or for the nursing home that leads to Medicaid and 
all kinds of Federal costs, where durable and medical equipment 
being available often can make the difference in whether that 
happens or not, available and supported by somebody who is able 
to really support the upkeep and servicing of the equipment?
    Secretary Azar. Well, Mr. Chairman, thanks to you and other 
members of the Senate and the House, we appreciate always being 
aware of the concern on rural durable medical equipment and the 
impacts that the reimbursement program was having on them, and 
that inspired us to act with the rule that we put out yesterday 
that we hope will provide some relief to rural DME (Durable 
Medical Equipment) providers. Ensuring that access for reasons 
you said is absolutely vital. To not do so can be pennywise and 
pound foolish.
    Senator Blunt. I think you've established a rate for most 
of the rest of this year. What do you expect to happen after 
that?
    Secretary Azar. So what we're going to do is we want to 
take the learnings. We had been on track for 2019, but we've 
actually put a pause on that to make sure we take the learnings 
from this experience of what we've seen in terms of what's 
happened to rural durable medical equipment. Of course, in the 
rule that came out yesterday we've come up with a 50-50 blended 
rate that we think will provide a lot of relief to these rural 
DME providers.
    We've also, in the budget, asked for two changes to how 
competitive bidding can work, and I hope we'll get support from 
Congress on this. The first is that we would pay winning 
suppliers, winning bidders, at their bid amounts rather than 
just at the lowest bid. There had been some bottom-feeding 
behavior going on that was actually making it unsustainable in 
rural communities to be a DME supplier even if you won the bid. 
And the second is to expand competitive bidding to all areas so 
that the bids are localized. So a rural provider isn't being 
judged and paid on, for instance, whatever an urban community 
bidding process would have resulted, which was the challenge 
under the current system.
    So we are very open-minded. We want to make sure this 
program works. Rural DME is very important, so we would seek 
any input and want to work collaboratively with both sides of 
the aisle to just make sure 2019 works better than it has.
    Senator Blunt. Thank you, Mr. Secretary. I'll have some 
more questions later.
    Senator Murray.

                                TITLE X

    Senator Murray. Thank you very much.
    Again, thank you for being here today.
    I wanted to ask about Title X. It is the only Federal 
program dedicated to providing family planning and related 
preventive care, including birth control and life-saving cancer 
screenings to uninsured or under-insured and low-income people. 
Every year Title X providers serve more than 4 million women, 
men, and young people.
    Now, while your budget does maintain the level funding for 
Title X at $286 million, as Democrats and Republicans agreed to 
in the spending deal we just reached and sent to the President, 
your budget actually would undermine access to care by 
attempting to exclude Planned Parenthood from participation in 
this. They provide basic healthcare service to 2.4 million 
patients every year. They serve more of the program's targeted 
population than any other Title X-funded provider, including 
four out of ten patients who receive contraceptive care through 
the program.
    So, Mr. Secretary, do you think the Federal Government 
should be in the business of telling women which doctors they 
can and can't see?
    Secretary Azar. So, Senator, we share your prioritization 
and concern for the Title X program, as you said, in our 
budget. We funded it at a level amount, and we want to ensure 
that that program works for the women and men who are able to 
make use of it. We want to make sure we've got a robust group 
of providers that are available that are able to reach people 
so they get the services. We want to ensure that it reaches a 
broad range of family planning services, which, of course, is 
the mandate in the Title X statute. So we want to have a 
diverse group of suppliers, of grantees, and we want to make 
sure that we have the full broad range of family planning 
services available per the statute.
    Senator Murray. Okay. Can you commit to maintaining a 
network of safety-net providers that will deliver the full 
range of high-quality family planning services to 4 million 
people nationwide?
    Secretary Azar. So, we believe that whatever we would do 
with Title X will ensure appropriate access to Title X 
services, as well as broader services more generally. Our grant 
process is actually seeking out a broad reach of providers and 
grantees who would be available for individuals.
    Senator Murray. Okay. Well, I hope that you will make the 
commitment to not remove a provider that actually provides 41 
percent of the currently served, and we'll be watching that 
very carefully.

                          AFFORDABLE CARE ACT

    Let me ask you about ACA (Affordable Care Act) while you're 
here. As you know, President Trump campaigned on the promise to 
guarantee affordable healthcare for everyone and protect people 
with preexisting conditions. It has been really disconcerting 
to see this Administration sabotage the healthcare system in 
many ways, driving up premiums. A recent study showed that 
millions more people are becoming uninsured.
    So I'm concerned that now, in another attack on patients' 
healthcare, HHS is proposing to expand the sale of short-term 
junk plans that allow insurance companies to deny coverage to 
people with preexisting conditions and exclude essential 
healthcare benefits, like cancer treatment or maternity care. 
Many of these junk plans spend as little as 50 cents of every 
premium dollar they collect on actual medical care, spending 
the rest on executive compensation, marketing, and overhead.
    Federal protections ensure that no one can be denied 
coverage or charged more based on their health status. So I 
want to be very clear, your proposed rule actually undermines 
those critical protections. Do you agree that the short-term 
plans your rule is promoting are allowed to actually deny 
coverage for individuals with preexisting conditions or charge 
them higher premiums or exclude these critical benefits?
    Secretary Azar. Senator, we share the goal. We want people 
to have access to competitive, affordable health insurance. 
Unfortunately, the Affordable Care Act is not delivering on 
that. We want to keep working with you on changes to make 
insurance affordable for individuals. But pending legislative 
changes, we want to make available to individuals who have been 
the 28 million men and women who have been forgotten and forced 
out of that market some kind of option. It may not be the right 
option for everybody, and we want to be very transparent about 
that. For some individuals, it may be better than nothing.
    So these same short-term plans are what the Obama 
Administration had for 8 years----
    Senator Murray. Well, those were short term, and the short-
term plans guarantee none of the critical consumer protections 
that are included in the individual insurance market, coverage 
for hospitalization, mental health and substance use disorder. 
Actually, a recent report found one that doesn't cover hospital 
stays on weekends. So your proposed rule would extend those 
very short-term plans which deny these coverages to a full 
year.
    So I'm really concerned that part of what is driving up 
premiums today is this rule, and I'm very concerned that 
families who enroll in these plans will have no idea and will 
be stranded without coverage when they are sick. So again, this 
is something we'll be following very carefully.
    Thank you, Mr. Secretary.
    Senator Blunt. Senator Alexander.

                            INSURANCE RATES

    Senator Alexander. Thank you, Mr. Chairman.
    Welcome, Mr. Secretary. Senator Murray and I agree on many 
things. One thing we do not agree on is health insurance. For 
example, as you just said, the short-term plan she's talking 
about is the same short-term plans that existed throughout 
almost the entire Obama Administration, and I want to 
congratulate the Administration on the associated health plan 
proposal which has the prospect of letting employees of small 
businesses have a chance to have the same kind of insurance 
that an IBM employee might have at much less of a cost and with 
the same protections. You couldn't be charged more because of a 
preexisting condition. You couldn't have your coverage denied 
because of a preexisting condition. You'd have to give coverage 
to your kids up to age 26, and there couldn't be lifetime 
limits.
    And in addition, rates didn't start going up with President 
Trump. They started going up with President Obama. In 2013, 
with the beginning of Obamacare, they went up 176 percent in 
Tennessee since 2013. We had a proposal which a month ago 
President Trump asked Speaker Ryan and Senator McConnell to put 
in the omnibus spending bill. They agreed. It was said it would 
reduce rates by 40 percent. It wouldn't have changed essential 
health benefits. It would have allowed coverage for preexisting 
conditions, no lifetime limits, so the Democrats blocked it. So 
that's a difference of opinion we have about who is responsible 
for the high rates which are coming because of Obamacare, and 
Democrats blocked our proposal a month ago.

                        OPIOID EPIDEMIC RESPONSE

    Now, one area we agree on is the urgent need for response 
to the opioid epidemic. Senator Murray and I in our health 
committee unanimously, after several hearings, reported a bill 
a few weeks ago, with contributions from 38 Senators with more 
than 40 proposals, to attempt to give States and communities 
and doctors and hospitals and judges more tools to deal with 
our largest public health epidemic.
    Have you had a chance to review that bill, and does the 
Administration support it?
    Secretary Azar. Thank you, Senator, and thank you for your 
commitment around helping to make options more affordable for 
individuals under the Affordable Care Act. And also we thank 
the committee and the Congress for the bipartisan work on 
opioids.
    I have reviewed some of the elements of the bill, been 
briefed on them. The Administration doesn't yet have a formal 
position, as you know, on the legislation, but there are so 
many very good things in there that I'm sure we'll continue to 
work together through the process of deciding on the 
Administration's position.
    Senator Alexander. May I ask you to give it your priority? 
Because the House of Representatives is working on opioids this 
month. They hope to produce a bill. I hope that our bill could 
go to the floor this summer, have contributions from other 
Senators. We invited many of them from other committees to meet 
the witnesses at ours, and we would hope to be able to deal 
with this problem this summer.

                        MEDICARE AREA WAGE INDEX

    Let me move to something called the Medicare Area Wage 
Index. This is an index which has a big effect on how hospitals 
are reimbursed, the 5,500 hospitals in the country, and from 
our way of thinking there is a big unfairness. Because of the 
wage index, for example, if a hospital in Connecticut billed 
$100 to Medicare next year, it would receive about $126. But if 
a hospital in Tennessee billed Medicare for $100, it would 
receive $82.
    As a result of that, a number of us in States, because of 
that discrimination, have introduced legislation to try to 
adjust the Hospital Area Wage Index because it's causing 
hospitals to close. CMS (Centers for Medicare and Medicaid 
Services) announced a rural hospital initiative, but it didn't 
include any relief from the Area Wage Index.
    Have you thought of ways to adjust the Area Wage Index to 
make it fairer, and especially to focus on rural hospitals?
    Secretary Azar. Senator, thanks for raising that issue. The 
wage index is one of the more vexing issues in Medicare, and 
challenging, in part because of the budget neutrality and 
adjustment. For any one State on the wage index actually hurts 
other States and leads to this constant back and forth of 
winners and losers there. We have and the prior administration 
had suggested to Congress that we would like to work together 
to actually come up with statutory changes to adjust the wage 
index approach to ensure better equity. Every year we are 
dealing with challenges in many States, in particular some 
rural areas, but we have issues constantly in certain East 
Coast States. So we would welcome the chance to work with you 
and others on appropriate reforms.

                              NIH FUNDING

    Senator Alexander. My time is up, but I want to conclude by 
saying one other area we agree on in this committee. Senator 
Blunt and Senator Murray deserve great credit for their 
leadership as they focus on biomedical research and funding for 
the National Institutes of Health, and we hope to continue 
that.
    Senator Blunt. Thank you, Senator Alexander.
    Senator Durbin.

                        MEDICAL RESEARCH FUNDING

    Senator Durbin. Following up on that, thank you, Mr. 
Secretary, and I want to thank the three Senators to my left 
for their leadership on medical research. I'm disappointed that 
the President's budget calls for a reduction of 6.2 percent in 
spending at the National Institutes of Health. I hope that we 
have the wisdom to ignore that suggestion and continue to move 
forward in critical medical research.
    The 32.5 percent decrease suggested by the President's 
budget for the Centers for Disease Control is equally vexing 
when you consider what we face now across this country in terms 
of public health challenges. So I'm counting on the three 
colleagues to my left, who have shown real leadership in this 
area. I hope Congress can show a better approach to the 
Administration.

                           TOBACCO ADDICTION

    Let me ask you to join with me in thinking for a moment 
about the issue of addiction today and how it has changed. I 
spent a major part of my congressional career fighting big 
tobacco for personal reasons, for family reasons, and for 
obvious public health reasons, and there are indicators that we 
started moving just slightly in the right direction, and the 
best indicator was the fact that we've seen a decrease in 
tobacco smoking among kids, from 28 percent in the year 2000 to 
8 percent in the year 2016. That's dramatic, because we learned 
that if you don't hook kids early while they're making the 
wrong decisions and are immature, it's very difficult to 
convince them to become cigarette smokers later in life. Good 
news.

                            OPIOID ADDITION

    Now let's talk about the sobering bad news that we face. We 
know from the opioid crisis that it strikes everywhere, not 
just in the inner city but in wealthy suburbs and small towns. 
I can prove it in my State. Everyone sitting here can prove it 
in their own State. It is an insidious epidemic, the worst drug 
epidemic we have faced in America, period. Now it is morphing 
into a new version of that epidemic that is even more 
frightening with the use of these synthetic narcotics like 
fentanyl, which can be produced, sadly, in a laboratory over a 
span of 48 hours in the United States. It's no longer a 
question of the poppy fields growing somewhere around the 
world. It's our backyard, and the opportunity people have to 
make fentanyl, to addict people, and to kill them with this 
synthetic drug.

                        E-CIGARETTE CONSUMPTION

    But it's not the only addiction. There is another one that 
I want to call to your attention that on your watch is becoming 
alarming. Between 2011 and 2015 the use of e-cigarettes, 
vaping, among high school kids increased more than 10-fold, 
from 1.5 percent to 16 percent. In my State of Illinois, 27 
percent of high school students are using vaping devices and e-
cigarettes. I talked to Dr. Gottlieb about this. When we 
confront the industry they say, no, this is about getting 
people off of cigarettes, on to vaping, which is not as 
dangerous.
    Well, that might make sense. Maybe that argument might have 
some merit until we look at the products that are for sale. Let 
me show you some of those products for the record.
    These are vaping products available, supposedly for adults 
to get off of using tobacco products.
    Jam Monster, a blueberry packaging flavor, which they say 
is the same as jam, butter, and toast.
    Here's another good one here, soft-serve ice cream flavors.
    Then when it comes to the flavoring, cupcakes, and 
raspberry yogurt cupcakes. Raspberry jelly if you don't like 
raspberry yogurt. Maybe you're lactose intolerant.
    [Laughter.]
    Senator Durbin. But the difficulty we have is that these 
are becoming so pervasive, so insidious, and so fast that when 
the FDA says we'll get around to this in 4 or 5 years, we don't 
have the time, Mr. Secretary. We don't have the time. We need 
to commit ourselves now to stop this.
    Did you read the Washington Post this morning? They're 
talking about the kids in the schools in the suburbs here can't 
bring flash drives to school anymore because it looks too much 
like a vaping product and they mistake one for the other. 
They're taking doors off the bathroom stalls in schools because 
kids are going into those stalls to vape during the course of a 
day.
    This is a galloping addiction and one that is affecting 
children across our country. My obvious question to you is 
what's this Administration going to do about it?
    Secretary Azar. Well, thank you. We share your goals here, 
totally. In fact, just last week the FDA went after--I don't 
know if it's those precise products. If not, they will be. 
These products that are clearly being marketed towards and 
aimed towards children, we are going after them, we will go 
after them.
    While the Commissioner has laid out an agenda that tries to 
balance having alternative nicotine delivery devices available 
as a means for exiting combustible addiction from cigarettes 
and other devices, we must ensure that these alternative 
nicotine delivery devices are not marketed for or become an 
entry point into tobacco, exactly the concern that you were 
expressing, and we will be very vigorous in going after any bad 
actors that are trying to market or aiming towards entry points 
for children or others into addiction.
    So I think we're completely aligned. We need to just talk. 
We want to ensure that we get adequate regulation and that we 
develop this space of the exit path for combustible tobacco. We 
want to make sure that that develops but that it's done the 
right way, uncompromising in terms of any kind of entry path 
for children or others into tobacco addiction. We would share 
that goal completely, Senator.

                        E-CIGARETTE CONSUMPTION

    Senator Durbin. I will tell you that while the jury is out 
on this conversion from combustible tobacco to vaping, as to 
whether that actually is a legitimate purpose for this product, 
while the jury is out, the vigor and commitment of the industry 
in hooking our kids is unmatched, and I don't think there's a 
sense of urgency or emergency in this Administration yet for 
something that could end up being, sadly, part of your legacy, 
to have stood by and watched as the percentage of kids in 
America became addicted, hopelessly addicted to nicotine 
through these products.
    Senator Blunt. Thank you, Senator Durbin.
    Senator Lankford.
    Senator Lankford. Thank you, Mr. Chairman.
    I appreciate the comments, and I agree completely on the 
issue on the vaping and things that are targeted towards 
children, what's going on in the opioid epidemic, and I look 
forward to working with the Secretary and with all of Congress 
on that issue, as well as what I would raise as an issue.

                         MARIJUANA LEGALIZATION

    Congress has been kind of double-minded on the issue of one 
point of promoting marijuana legalization, and the other point 
of trying to be able to go after vaping. So I would hope that 
we would speak with a consistent voice on these issues, that 
encouraging more people to use marijuana doesn't exactly help 
us either long term, and that we should be consistent on our 
message to not say opioids are bad but marijuana is good.

                       PHARMACY BENEFIT MANAGERS

    Let me go back to one of your comments earlier you made in 
your opening statement. You talked about the middleman in 
prescriptions. I assume you're talking about the PBMs (pharmacy 
benefit managers). That has been a big issue and a major driver 
of cost. Obviously, when the EpiPen conversation came out for 
the first time, millions of Americans heard about PBMs for the 
first time and started asking questions about it. It's been a 
big issue for a while.
    Where is that going right now in the ongoing conversation 
about how the dollars for any of those prescriptions are 
getting to the producer or dealing with the consumer or the 
person delivering it in the pharmacy but not to the PBM in the 
middle?
    Secretary Azar. Thank you for asking about that. That will 
be a focus of the President's announcement tomorrow, addressing 
every element of the pharmaceutical pricing channel, including 
those who negotiate for so many of us, the pharmacy benefit 
managers, and their role. They serve a very important purpose.
    Senator Lankford. Sure they do.
    Secretary Azar. But I think it's very important that we 
address the incentives in the system, who are they working for, 
who are they being paid by, and where do the savings go to.
    Senator Lankford. Well, it's been clear that insurance 
companies are purchasing pharmacies and such to get access to 
the PBMs in the middle. Seeing that that becomes the pathway to 
actually greater profits is actually being able to own that 
PBM. But it's also, as you mentioned in your opening statement, 
questions about competition. If competition is important, local 
pharmacies are important.

                            RURAL PHARMACIES

    Let me ask for your perspective on this, as well. For the 
local pharmacist, especially a rural pharmacist, and the DIR 
fees that are coming back, trying to recapture some of these, 
how do we protect the local pharmacy in rural areas to make 
sure that we still have those local pharmacies, that not 
everything is mail order but patients have the opportunity to 
be able to ask face-to-face questions on it, but we're not 
trying to go back 6 months later and trying to recapture things 
from a DIR fee?
    Secretary Azar. Senator, I'm glad you raised this issue. It 
is something that's been on my radar and is a concern for me, 
and I'm going to actually ask our Inspector General to ensure 
that he's looking into this question. The issue you're raising, 
as I understand it, is often when you have these large pharmacy 
benefit managers that own their own mail-order specialty 
pharmacy but they also have to interact with local or non-owned 
specialty pharmacies, are these DIR fees essentially taxes 
imposed differentially and unpredictably on those independent 
pharmacies in a way that puts them at a competitive 
disadvantage from the owned ones.
    I think this is an important issue worthy of study because, 
as you said, there should be a level playing field and there 
should be good competition. So I'm going to ask the IG 
(Inspector General) at HHS to look into this issue.
    Senator Lankford. Thank you. I appreciate that very much 
because that is an issue, and it shouldn't be months later when 
they actually find out about the DIR fees. So a local pharmacy 
will charge a client $10 for a pharmaceutical, and then a DIR 
fee comes back later that's a $9 clawback on it 6 months later. 
That pharmacy is obviously long gone. They're now going to go 
back to their customer and say I undercharged you on this. It's 
become a big issue for them, and it's related to what Senator 
Alexander was talking about before with the wage index.

                               WAGE INDEX

    If you've got a cardiologist in Oklahoma doing a procedure, 
the wage index becomes a big issue because the device they may 
put in, whether it be a pacemaker or any other valve, whatever 
it may be, the device is the same cost whether you're in 
Oklahoma or New York City. But in Oklahoma, the cardiologist 
makes a tiny amount because most of the cost of reimbursement 
is the device, while in New York City the device, which has the 
same cost, the cardiologist gets a very large amount. So what 
happens is if you're a cardiologist, your tendency is to move 
to the East Coast where you can get paid more for the same 
procedure. If we want to have fair medical treatment for 
everyone across the country, we've got to also be able to 
balance out not just the cost of the device and reimbursement 
but also what the doctors themselves are being reimbursed on 
it.

                            RURAL HOSPITALS

    Let me also mention to you as well about the rural 
hospitals. We've got multiple layers I'm going to try to chat 
with you about because some of them are issues that you all are 
dealing with, like the abortion surcharge that's ongoing. 
Obamacare, in the very earliest days, said that has to be a 
separate billing amount, but it obviously has proved not to be 
so and is one of those things I want us to be able to work on 
to be able to establish.
    But for rural hospitals, in 2015, 15 hospitals were 
designated as vulnerable rural hospitals. By 2016, we had 42 
hospitals that were designated as vulnerable. By 2017, we had 
41 hospitals, but in the same time four of those hospitals are 
closed. We have major issues that are rolling out with the 
Affordable Care Act which disproportionately hit those rural 
hospitals.
    I know you all are making some recommendations on this. I 
just want to be able to say this is of epic importance to rural 
hospitals, that we do resolve some of the issues that we have 
there in reimbursements, telehealth, all of those things that 
become so important. We're losing emergency rooms, and we're 
losing access in rural areas, and it will be exceptionally 
important to deal with that.
    Thank you, Mr. Chairman.
    Senator Blunt. Thank you, Senator Lankford.
    Senator Manchin.
    Senator Manchin. Thank you very much, Mr. Chairman.
    Thank you, Secretary. It's good to be with you.

                              JESSIE'S LAW

    First of all, we finally got a bill called Jessie's Law, 
and I think I sent you a letter on that. I want to follow up on 
that because it's such a commonsense piece of legislation. This 
little beautiful girl, Jessie Grubb, as you know, had an 
injury, and she was an addict, and she was trying to clean up, 
and she was doing very well in rehab. She had a running injury 
and went to the Michigan hospital and told the doctors. Her 
parents were with her. She was so proud of being a recovering 
addict and wanted to be very careful about the markings on all 
of her transcripts as far as her admission to the procedure she 
was going to need.
    To me, I just thought it was commonsense, are you allergic 
to penicillin, something very critical. It wasn't. She got 
discharged, the doctor didn't see it, gave her a prescription 
of OxyContin, and she had overdosed by that evening and died.
    So what we're saying is this piece of legislation, you all 
have it now to set some guidelines and rules, making sure about 
the procedure. So I think what I need, and I know you feel the 
same, committing your agency to begin work on these standards 
and disseminating it as quickly as possible. Medical 
professionals all over the country are going to have guidelines 
of how they mark if there was a patient coming in identifying 
themselves of this nature.
    Have you all started, or have you received that in the 
office?
    Secretary Azar. I have not been briefed in our efforts in 
response yet, but I can assure you that will be a high priority 
for us as we share the goal. We want to make sure that gets 
all----
    Senator Manchin. This was all preventable. Senator Capito 
was a co-sponsor with me on this. It should have never 
happened, and they just want to make sure this beautiful little 
girl didn't die in vain, and saving others. So for all your 
staff here, it's called Jessie's Law. It was in the omnibus 
bill. You have a letter on that. We'd be happy to work with 
you. I know that Senator Capito's staff would be the same, 
anything we can help you with.

                              DRUG PRICING

    Let me go right into--because people say how come I can 
order drugs from Canada and get them so much cheaper? Why are 
the drugs so expensive? Why are pharmaceuticals charging so 
much? Why are drugs protected for such a long period of time 
before they're able to be sold as cheaper generic drugs?
    The whole pricing structure, the PBMs, the purpose of PBMs, 
are you all looking at that? They're telling me that it's the 
pricing structure and how we sell drugs to the consumer is why 
the cost is so much different than anyplace else in the world.
    Secretary Azar. Tomorrow the President will be rolling out 
a comprehensive plan around drug pricing that addresses all 
aspects of the channel, including the role of the pharmacy 
benefit managers, drug companies, others in the system, 
highlighting exactly the types of issues you're raising, and 
also going after this question of foreign governments that free 
ride off of American investments.
    Senator Manchin. Would you say, Secretary, that a lot of 
the pricing in America, being some of the highest cost in the 
world for life-saving drugs and drugs that are needed for 
quality of care for people, is it because of the pricing, the 
way we sell it, the way we get it to market that's causing 
that?
    Secretary Azar. I don't believe it's the selling and 
marketing is the reason. It's basically government structures 
and payer systems. What happens in the United States, some of 
our plans and some of our approaches actually drive as good or 
better deals as some of the socialist systems abroad, and then 
in other parts of programs and for other medicines foreign 
governments, socialist single-payer systems get a better deal.
    Now, often that deal comes at the cost of rationing and 
access, and patients who are suffering from cancer or HIV/AIDS 
or MS or rheumatoid arthritis, they can't get access to the 
medicines that you can here in the United States because that's 
exactly what the socialist systems do. So it is a balance.
    But what the President is going to be trying to do is 
trying to tackle the elements of our program, how do we make 
them better so that we pay less and of course, get foreign 
governments to pay more.

                            OPIOID EPIDEMIC

    Senator Manchin. I have to hurry up real quick. I look 
forward to that report tomorrow, and if we can start down the 
path and get cheaper drug prices and access to cheaper drugs on 
the market in America, it's going to be very helpful to West 
Virginia.
    We have in West Virginia the largest per capita economic 
burden in the country as far as opiate deaths, as you know. The 
amount of money, how it was being disbursed out before, was not 
based on the amount of rate of per capita deaths that you had. 
It was based on population, and I think Senator Capito and I 
both have been working on this.
    So what we need is you working with us, a commitment to 
work with us to make sure the money is getting to the front 
line. You have a war on drugs. We are the front line. We are on 
the battlefield every day, and States like us in different 
parts of the country. Have you all recognized that? Are you 
directing the money to come to the areas of need?
    Secretary Azar. Yes, and thank you for that concern. We 
appreciate the flexibility that this committee and Congress 
gave us in the omnibus to actually target money towards the 
highest-burden States on opioids, and we will faithfully----
    Senator Manchin. We have a 15 percent set-aside, but that 
depends on how quickly and how capably you all are able to 
administer it to make sure it gets to that front line, because 
we're in need. We're very much in need.
    Thank you, Mr. Chairman.
    Senator Blunt. Thank you, Senator Manchin.
    Senator Kennedy.
    Senator Kennedy. Thank you, Mr. Chairman.
    Mr. Secretary, how are you?

                          MEDICAID ENROLLMENT

    How many people are on Medicaid?
    Secretary Azar. The actual numbers on Medicaid--you know, 
Senator, I want to make sure I've got that exactly--70 million. 
I'm sorry.

                       MEDICAID WORK REQUIREMENTS

    Senator Kennedy. Okay. Do you know anybody on Medicaid who 
is able to work, or on any social program who is able to work--
and by ``able to work,'' I mean not elderly and not disabled--
who doesn't want to work?
    Secretary Azar. I certainly hope all would. I hope all 
would. I view those as being able to work and working, when one 
is able, as such a fundamental aspect of one's own dignity, as 
well as, we think, healthcare----
    Senator Kennedy. We can agree with all that. I don't know 
anybody. I mean, I'm not saying there aren't folks out there, 
but I've never talked to a person on Medicaid who was able to 
work that didn't appreciate that he or she would be better off 
with a job and being able to buy their own health insurance.
    I've seen numbers that show we have 28 million people on 
Medicaid who are not elderly and not disabled, who could work 
if they could find a job but don't work. I've seen numbers that 
show we spend about $150 billion a year on that subset. I've 
seen numbers that say about 40 percent of those 28 million 
don't have children.
    I think part of the problem is that many of these folks-- 
I'm not saying all. I mean, I'm not naive. But many of these 
folks would like to know the dignity of work, but they need a 
little help about getting that job.
    Now, the economy is rocking. I think it's because of our 
tax bill. I know there are some who disagree with that. I don't 
understand why the Administration does not loudly and 
aggressively say, look, the free market--and by that I mean 
being able to get a job--has done more to lift people out of 
poverty than all the social programs put together, and if you 
don't believe me, I give you China. It's not the Communist 
Party that lifted so many of the people in China out of 
poverty. It was because they adopted a form, anyway, of 
capitalism.
    And I don't understand why the Administration--and I wish 
you would take this back to the President, because I think 
he'll agree with me--doesn't say, look, we don't want to throw 
people out in the cold, but we want to help them understand the 
dignity of work. It's a win/win. It's better for our fellow 
Americans to know the dignity of work, and it's better for the 
American taxpayer. And let's put together an aggressive program 
that's not optional for the States. My governor doesn't want to 
do it. My governor--I believe in more freedom. My governor 
believes in more free stuff. That's just the way it is. I'm not 
criticizing him, I'm just describing him.
    But put together a program not to throw people out in the 
cold but just to say, look, let us help you get a job. You can 
keep your benefits, but let us help you get a job. If your 
children were older, we'll help you get that job. We'll point 
you in the right direction. We'll help you find a way to get to 
work. You've got to do it for 20 hours a week. You can keep 
your benefits. You'll feel better about yourself, and let's do 
it.
    I appreciate that CMS is willing to grant waivers, but why 
don't we take the next step? Why don't you take the lead on 
that?
    Secretary Azar. I believe the President has led boldly here 
with the welfare reform executive order, with what we're doing 
in Medicaid----
    Senator Kennedy. How about if we pass a bill?
    Secretary Azar. Well, we would work with Congress. SNAP 
(Supplemental Nutrition Assistance Program), the SNAP program, 
the President has wanted work requirements in there.
    Senator Kennedy. But they're optional.
    Secretary Azar. Yes, but then----
    Senator Kennedy. Sorry to interrupt, and I'm not trying to 
be rude, I'm really not, but I'm down to 11 seconds. We don't 
need to make it optional, and we need you to take the lead, and 
the President. I mean, the President is kind of busy right now. 
He's working on a lot of stuff. I'd like you to take the lead, 
and CMS to take the lead and say this is a win/win, and we're 
not going to kick people out in the cold. We're going to help 
them know the dignity of work. Taxpayers will be better off. 
They will be better off. And it's not going to be optional for 
governors.
    Sorry, Mr. Chairman.
    Senator Blunt. Thank you, Senator Kennedy.
    Senator Murphy.
    Senator Murphy. Thank you very much, Mr. Chairman.

                           CMS REIMBURSEMENT

    I know that Senator Alexander isn't here, but I just want 
to make a note for the committee and for the Secretary on the 
reason why we have the wage differential. I say it because 
Senator Alexander referenced the difference in payments to 
Connecticut and to Tennessee.
    We're a big country. We have different costs of living. We 
have different rates of pay from State to State, and that is 
the reason why Medicaid and Medicare reimburses slightly 
differently. It, of course, results in the average Connecticut 
taxpayer sending $14,000 to the Federal Treasury and the 
average Tennessee taxpayer sending about $8,000 to the Federal 
Treasury. If we are interested in equity and parity, then we'd 
be more than happy to adjust tax rates to send $8,000 to the 
Federal Treasury instead of $14,000. And if that was the deal, 
then maybe we'd be happy to accept less in Medicare 
reimbursement. But there's a reason why you pay a little bit 
more for Medicare in Connecticut. That's also the same reason 
why the Federal Treasury gets a lot more from Connecticut. I'd 
point that out for the record.

                            INSURANCE RATES

    I want to continue along the line of questioning from 
Senator Murray, Mr. Secretary, on this campaign of sabotage 
that's been waged by the Administration, driving up rates all 
across the country. This is a quote from the head of the 
largest health insurance company in Maryland, talking about why 
they were going to be dramatically increasing rates, especially 
for plans that tend to be used by sicker patients.
    He attributed these rate increases to the continuing 
actions on the part of the Administration to systemically 
undermine the market and make it almost impossible to carry out 
our mission. In making that statement, he talked specifically 
about PPO plans, which are favored by sicker patients, people 
with chronic illness. In fact, in one of those plans in the 
recent rate filing, premiums went up by 90 percent in Maryland.

                            INSURANCE PLANS

    So it gets me to this question of the short-term plans, the 
junk plans, what we would call the short-term plans and the 
effect that it will have on the market. The worry, of course, 
as you know, and the reason why President Obama moved the time 
duration down to 3 months, is that because these plans are not 
subject to the requirements that you cover people with 
preexisting conditions the same, that you have a minimum 
standard of benefits, you'd have a migration of healthy people 
to these plans and you'd leave all the sick people, people with 
preexisting conditions, behind. I think you're already seeing 
that in the price increases on the exchanges. So that's the 
reason why the Obama Administration said, listen, we're going 
to make these short-term plans actually short term, 3 months.
    So how do you gauge what insurance companies are already 
predicting, that there will be a massive migration of healthy 
people into these short-term plans that are now effectively a 
complementary option to the exchanges, driving rates up for 
people with preexisting conditions, people who simply can't go 
on those plans if they don't cover everything that they need?
    Secretary Azar. Senator, first, good to see you again.
    I would say first it's important to remember that what's 
been proposed--nothing is final, but what's been proposed on 
the short-term plans is to restore what President Obama had in 
place until the eve of his retirement from office. He kept 12 
months in place the entirety of his presidency in the program.
    It's next important to remember that of the about 10 
million people in the individual market, over 82 percent of 
them, we're buying their insurance for them. They're 
subsidized. People are not going to be leaving subsidized 
insurance with the full slate of benefits for these short-term 
plans. The individuals that these plans are going to be 
available for and it's going to make sense for are the folks 
who have been left out in the cold by the Affordable Care Act 
now, those 28 million folks who are sitting out there who can't 
afford these skyrocketing price increases that happened under 
President Obama in his own plan. We're just trying to make 
options available. They're not going to be right for everybody. 
We're being very transparent about that, but we want those for 
options for those if it makes sense for them.
    But what we really have to be working on together is fixing 
what is wrong, what's not working here, which is the Affordable 
Care Act. It's not delivering. The price increases were 
happening before President Trump. They're continuing. It's not 
functioning, and we want to work together to come up with a new 
system.

                             ACA ENROLLMENT

    Senator Murphy. With all due respect, it's just not true 
that it's not functioning. Even with this deliberate campaign 
of sabotage, even with the Administration cutting the open 
enrollment period, even with the Administration stopping the 
marketing of these plans, even with the Administration refusing 
to pay for the navigators, the same number of people signed up 
last year that signed up the year before. I don't think that 
will continue because at some point 90 percent price increases 
are going to force people off no matter how big the subsidies 
get.
    So I'm very worried, Mr. Chairman, about the separation of 
the market into very healthy and very sick as these short-term 
plans now become true, viable options right next to the 
exchanges. I look forward to continuing the dialogue. Thank 
you, Mr. Chairman.
    Senator Blunt. Thank you, Senator Murphy.
    Senator Capito.
    Senator Capito. Thank you, Mr. Chairman.
    Thank you, Mr. Secretary, for being here.

                           21ST CENTURY CURES

    I'd like to follow up on a question that my fellow Senator 
from West Virginia talked about, and you and I have talked 
about this, and that is trying to target the 21st Century Cures 
dollars to the tip of the spear where we have the highest age-
adjusted mortality rate in the country.
    I just want to ask for a clarification, because my 
understanding when we talked about this was that the last 
tranche of money that went out, it went out on the old formula 
basis, but the next tranche of money that's coming out in 
September or October will have this target adjusted.
    Could you kind of confirm that for me and maybe explain a 
little bit?
    Secretary Azar. Yes, absolutely. Thank you, Senator. As I 
mentioned to Senator Manchin, we appreciate both. There's the 
targeted holdback from the omnibus of, I think, 15 percent, if 
I remember correctly.
    Senator Capito. Right.
    Secretary Azar. That is deliberately targeted to the 
highest-burden States. But in addition, we appreciate the 
flexibility that Congress gave us now on the remainder of the 
money that we would put out in September to also, with regard 
to that money, try to focus it on the highest-burden areas of 
the country. So I think on both sides of the fence there would 
be our goal to target where most needed in the country.
    Senator Capito. Well, I think that makes a lot of sense. To 
those of us in States who are not as highly affected as our 
States are at the very beginning, if we don't nip this in the 
bud where we are and find best practices, unfortunately I think 
it's going to cascade in the numbers that we see in our area.
    Another area of concern that I have, we see a lot of money 
going into this, we see a lot of recovery and treatment and a 
spectrum of solutions, and I welcome all of that, from drug 
courts to naloxone to medication-assisted treatment to help 
with foster families, et cetera, et cetera.

                        OPIOID RECOVERY CENTERS

    I do have in the back of my mind a concern, and we've seen 
some news reports where recovery centers have sort of sprouted 
up without the proper oversight as to what type of treatment is 
being offered, what kind of recovery programs. In some cases, I 
believe there was a case where in the treatment program, the 
person who was in charge of that, or the owner of it, was 
actually giving the users more drugs to keep them sort of at 
bay.
    So I don't know where your quality control is on this. Is 
it more at the State? Is it at your level? And what you all are 
doing about that.
    Secretary Azar. So, I'm glad you raise that. It's a really 
important question, and that's something that even on the last 
round of funding that went out, the $495 million that went out 
just a couple of weeks ago, SAMHSA (Substance Abuse and Mental 
Health Services Administration), with Dr. Ellie McCance-Katz, 
imposed conditions there, for instance, that the money could 
only go to treatment centers that used medication-assisted 
therapy, because we know that works and it ought to be 
available if the precious money that the Congress has allocated 
is being spent there.
    We're going to keep looking as we move forward to September 
again on best practices, best approaches. We want to be 
collaborative, but we also want to make sure this money doesn't 
just get spent any which way but goes towards the real 
approaches that are going to work to help solve this problem, 
so exactly the kind of situation you're talking about. The 
learning process for us is primarily State regulation. But we, 
of course, through the grant process as we release the money, 
can impose conditions on that, on how that should be spent. And 
as we learn, get input from you and others, what's working and 
not working and where there are risks of abuse, we want to take 
advantage of the opportunity.
    Senator Capito. I welcome that. I would also say our 
local--in West Virginia, we also have Recovery Place, and we 
also have Rea of Hope that are abstinence treatment, and they 
have some success here, a lot of success. So we just need 
quality reassurance that we're not getting pop-ups to solve a 
very deep and devastating problem.

                    ALZHEIMER'S FUNDING AND RESEARCH

    The other area of concern for me in health, and it's such a 
large area in general, is Alzheimer's and what we're doing in 
terms of treatment research, helping caregivers, palliative 
care, all the things. I'm personally touched by this in my own 
family, as many of us are.
    So from the Department's perspective, I know you're doing 
research. I know Medicare is trying to help with some of these 
issues. What perspective can you bring to us today?
    Secretary Azar. Well, of course, we've got a comprehensive 
and deep commitment around Alzheimer's, just as you do. At NIH, 
with the money that this committee allocates to us, I think 
we're currently supporting over 140 clinical trials in that 
space. It's an area I happen to be quite familiar with also. We 
need to keep looking in the Medicare and Medicaid space to see 
ways that, again, my theme of not being pennywise and pound 
foolish, are there ways that we can support caregivers and 
others and non-traditional ways, I think, to ensure that we 
avoid perhaps early institutionalization of individuals.
    Senator Capito. Right.
    Secretary Azar. So I'm open for any ideas and best 
approaches that we can take across the board. In addition to 
our research support, also on our payment side, how we can help 
the families who are dealing with this devastating disease.
    Senator Capito. Thank you.
    Thank you, Mr. Chairman.
    Senator Blunt. Thank you, Senator Capito.
    Senator Schatz.
    Senator Schatz. Thank you, Mr. Chairman.

                         CONNECT FOR HEALTH ACT

    Secretary Azar, thank you for the conversation the other 
day. I want to follow up on it. I want to talk about something 
rare, something we all agree on, and that is telehealth. You 
said you're a big supporter of telehealth. I'm pleased to be 
able to work with you on the implementation.
    We still have a bill called the Connect for Health Act, 
which is bipartisan and bicameral. About half of it was enacted 
in the last CR (Continuing Resolution). So we're going to make 
good progress in that space, lifting certain restrictions 
around Medicare. But the last piece, and for me the Holy Grail, 
is to give the Secretary waiver authority, assuming his or her 
actuaries determine that waiving barriers to telehealth around 
Medicare would pay for itself.
    So I'd like you to talk about how you would use that waiver 
authority and how we would expand access and reduce cost.
    Secretary Azar. Senator, again, thank you for the 
discussion we had on this. I do think this is a very bipartisan 
area where we can all get together, whether it's in rural 
health, remote frontier health, or just containing cost and 
being efficient. That's the world of telehealth. The biggest 
challenge, of course, is that our payment systems are sort of 
frozen in the 1960s so often in Medicare and Medicaid.
    If I were to be given that authority, probably the single 
biggest countervailing pressure we have is, of course, 
integrity and ensuring program integrity there through 
telehealth, that we don't see abuse. I mean, I think so many of 
the rules that we have is some bad provider did something, and 
so you put a rule in place. Obviously, we have to do it with 
respect to the taxpayer, program integrity, but I would want to 
be very forward leaning here on implementing any authority; 
again, pennywise and pound foolish. Using telehealth, expand 
the network of providers, expand the reach to communities, 
really help in rural and frontier communities, and lower the 
cost of care. So I'm with you on this one.
    Senator Schatz. Thank you. I think reaching veterans, 
reaching people in rural communities, helping with the opioid 
crisis, asthma, psychiatric/psychological treatment, all of it 
can be done through telehealth. And I think the transformation 
in our society is that if 10 years ago you were instructed to 
interact with your clinician through a device, you would be 
irritated, and now there is a category of clients or patients 
who, if they are not able to interact with their clinician 
through a device, they are irritated. So this is 
transformational, and I know the Chair and Ranking Member are 
very supportive.

                         STATE ACA FLEXIBILITY

    I want to ask you another question. Clearly, your 
philosophy--I'm not sure if it's fair to call it Federalism, 
but you want to provide maximum flexibility to States in terms 
of interpreting ACA and other statutes and in terms of 
configuring the healthcare system that makes most sense either 
through the State insurance commissioner or through the 
legislature.
    So I want to ask you maybe a ticklish question, a tough 
one, which is it is one thing to provide flexibility if it is 
in the interests of your view of where healthcare should go. 
What if a State comes to you and says we want to do a Medicaid 
public option? What if a State comes to you and says we want to 
do something left leaning, progressive leaning, more coverage, 
and more government involvement?
    I am assuming, because of my brief interactions with you 
and your reputation, that you would provide the same 
flexibility as it relates to a progressive proposal that you 
would provide to anything that is designed to, in my view, 
evade or undermine ACA.
    Secretary Azar. I think you've seen that with our 
behaviors. For instance, our collaborative approach working 
with the State of Maryland on their all-payer program that 
they've had, which some would have a lot of concern depending 
on ideology, but we've tried to work with them to see if it's a 
model of value-based payment that they're approaching, and 
we've tried to be very collaborative in working with them.
    We also, in our budget proposal, have a proposal to 
Congress that we would offer up to five States the opportunity 
to negotiate directly drug pricing through their Medicaid 
programs to test and see if that can deliver better results 
than the rebate program.
    So we try to be open-minded. We have certain restraints 
around Medicare and Medicaid waiver, of course, protecting the 
public fist. There are certain budget neutrality requirements 
that, depending on what one wanted to try to do at a State 
level, might also run contrary to that, and that might be an 
outer-limit barrier, certainly.

                           INDIVIDUAL MANDATE

    Senator Schatz. And I'll just have one final question. Tom 
Price said that repealing the individual mandate will harm the 
pool and likely have individuals younger--you know this. You 
know the quote. It's adverse selection. It will drive costs up. 
Do you agree with Tom Price? Do you think he misspoke?
    Secretary Azar. I think he--my understanding is he backed 
away from that statement a little bit later.
    Senator Schatz. I understand he backed away.
    Secretary Azar. But I will tell you my view on the 
individual mandate, which is I really do not believe that it 
will have a significant impact on our risk pool, the repeal of 
that. We already had 6.7 million Americans paying $3.1 billion 
of taxes a year, 80 percent of them earning $50,000 or less, 
because they can't afford this insurance, it doesn't work for 
them. I think the people who were getting in that pool, as I 
mentioned earlier to Senator Murphy, are people who we're 
basically subsidizing access to. It's not the mandate that's 
gotten them there. It's that we are basically giving them 
insurance. That's why they're in there. So I don't see the 
premium----
    Senator Schatz. It just seems you're such a person who 
relies on data and expertise in so many instances, but you are 
disagreeing with the consensus among actuaries and healthcare 
experts of exactly what the individual mandate did.
    But my time has expired. Thank you.
    Senator Blunt. It has. There will be time for a second 
round if anybody wants to ask more questions.
    Senator Moran.
    Senator Moran. Senator Blunt, thank you.
    Mr. Secretary, thank you for being here. I don't know you 
as well as I'd like, and I look forward to developing a strong 
relationship. There are so many things within your Department 
that are so important to the citizens I represent.
    This may be me doing more talking than you, and I apologize 
for that, but I want to highlight some things in your budget 
request that are, in my view, worthy of my reaction.

                              NIH FUNDING

    First of all, NIH. The budget that is before us is a $6 
million reduction in NIH funding. I would indicate to my 
colleagues, and certainly to the Ranking Member and Chairman of 
this committee, that we ought to continue our efforts in 
finding ways to fund NIH at increasing rates and certainly 
without reductions.
    In a broader sense, I think we as a Congress for a long 
time have focused on who is going to pay for healthcare, as 
compared to how can we make healthcare less expensive. The 
focus is how we shift unaffordable healthcare to someone else 
who it is still unaffordable for. So it seems to me that the 
underlying cause of why healthcare is expensive is where we 
ought to focus, and you are doing that, and I appreciate that.
    NIH, in my view, is one of those things. Not only does it 
improve people's quality of life and longevity, it's wonderful 
for families. But if we could find the delay to the onset of 
Alzheimer's, if we can eliminate cancer, reduce diabetes, all 
those things have a tremendous cost consequence, and we ought 
to be pursuing them.

                           GLOBAL HEALTH FUND

    In regard to the CDC, I would advocate for continued 
funding of the Global Health Fund. One of the things that was 
said recently in the rescission discussion from OMB (Office of 
Management and Budget) was that Ebola, in a sense they were 
saying that Ebola has been taken care of, no reports of Ebola. 
There were two reports from Congo shortly thereafter. But I 
also would say that regardless of reports of Ebola, we need to 
continue to have the funding necessary for the infrastructure 
so that we don't start anew, we don't have the crisis that we 
had when Ebola arrived. And for us, this is not just a problem 
in Africa or elsewhere in the world. The consequences of Ebola 
and other highly contagious, deadly diseases has a huge 
consequence upon Americans, and we saw that with Ebola.
    So I would highlight the importance of not eliminating the 
infrastructure that's in place to fight these highly dangerous 
and contagious diseases even though there may not be a report 
of that particular disease at the moment.
    So those two things I wanted to mention.

                       PHARMACY BENEFIT MANAGERS

    I walked in as Senator Lankford from Oklahoma was talking 
about drug pricing transparency, PBMs. Senator Capito and I 
have long been supporters of legislation that requires 
transparency in the PBM world. I can tell you our legislation 
has not advanced very rapidly, and I would look forward to 
hearing from you, knowing from you how we could be of 
assistance to you in your department's efforts.
    But this issue of rebates that's now front and center, I 
think maybe our conversation is better had once the 
announcement from the Administration occurs as to what your 
plan, what your policies are going to be. But this, again, is 
an example of if we can find ways to reduce unnecessary costs 
in healthcare and the cost of healthcare, we can reduce the 
unnecessary cost of healthcare.
    So I applaud the Department's efforts in regard to drug 
reform, and particularly as it relates to PBM transparency and 
the rebate issue. I'm encouraged.

                                 340(B)

    You and I visited on the phone, I guess it's now last week. 
I would highlight for you once again the importance of the 
340(b) program. Our hospitals, from our largest in our most 
urban settings to our critical access hospitals, all of them 
are fragile. This is a funding source that helps the patient as 
well as the provider, and in your alterations, if there are 
any, of 340(b), I guess we're now waiting on the courts to tell 
us some direction, provide us some direction, but I would 
highlight the importance of this 340(b) program.
    There are 127 hospitals in Kansas; 80-some of them are 
critical access hospitals. Almost without exception, they're 
hanging on by a thread, and any alteration in their 
reimbursement rate means that there is going to be less access 
to healthcare in rural places in particular, but in urban 
places as well, and particularly the core center of urban 
centers. We have both in Kansas. Johnson County is our suburbs 
of Kansas City. One of the smallest towns in our State is 
Johnson City. So from east to west, this is a huge issue.
    It highlights for me--I didn't realize when sequestration 
was passed that we had across-the-board cuts as they affected 
critical access hospitals. I thought sequestration would not 
apply to critical access hospitals. I didn't vote for 
sequestration, but as a bad policy, it's the wrong way to 
approach the appropriations process. But I would have never 
thought that we would reduce across-the-board funding that 
affects critical access hospitals that are to be paid on a cost 
basis. This 2 percent across-the-board cut, my view, my 
colleagues and I need to make sure that this is not extended 
even further and look for opportunities for its demise.

                     TRIBAL MEMBERSHIP DESIGNATION

    Perhaps the only last point I would make, Mr. Chairman, is 
tribal labor sovereignty, the words I use. CMS, the Center for 
Medicare and Medicaid Services, has taken upon themselves to 
declare Native Americans to be classified as a racial group 
rather than as citizens of a tribe. I think you're wrong. I 
think tribes should be treated and deserve the sovereignty that 
they are entitled to by our Constitution and our longstanding 
understanding that Tribes are governmental, not racial, and I 
hope that CMS will take a look at that issue once again on 
behalf of the Tribes.
    Thank you for answering all my questions.
    [Laughter.]
    Senator Moran. At least I can say thank you for listening 
to my comments.
    Secretary Azar. If I might, Mr. Chairman, we did just 
earlier this week revise that guidance on CMS, so we'll be 
happy to get that to you.
    Senator Moran. With regard to Tribes?
    Secretary Azar. With regard to the community engagement, 
and if you're talking about the community engagement 
participation in States that have received those waivers and 
Tribal connectivity to that, we have actually issued modified 
guidance on that this week.
    Senator Moran. I'll take a look. Thank you very much.
    Senator Blunt. Thank you, Senator Moran.
    Senator Baldwin.
    Senator Baldwin. Thank you, Mr. Chairman.

                              DRUG PRICING

    Welcome, Secretary Azar. I want to start with the issue of 
the high price of prescription drugs.
    Reports showed last year that the pharmaceutical industry 
spent over $170 million in lobbying, deploying over 880 
lobbyists to influence Washington policymakers. This investment 
paid off for their CEOs and shareholders. First-quarter 
earnings saw seven of the largest drug companies in aggregate 
receiving $12.1 billion in profits. This is since the beginning 
of this year.
    Meanwhile, large drug corporations received a tax cut from 
the Republican tax bill, and have spent a combined $50 billion 
on new stock buybacks, and enriched shareholders and executives 
while still continuing to increase prices on existing drugs.
    Now, I understand that the President will be outlining a 
plan to address drug prices. We've been anticipating it since 
his big announcement at the State of the Union address, and 
I'll be very interested in hearing what will be included.
    At your confirmation hearing before the HELP committee, we 
had an exchange on this issue of the ever-increasing price of 
particular prescription drugs, and you blamed, and I quote, 
``the system'' for the rising cost of prescription drugs, but 
you never singled out the role that drug corporations play in 
this system.
    So I want to know whether the Administration's plan is 
going to include actions that hold drug companies specifically 
accountable for their role in setting the price of drugs and 
increasing the price of drugs. Yes or no?
    Secretary Azar. Oh, yes it will.
    Senator Baldwin. Okay.
    Secretary Azar. All players will be impacted. As I said, 
it's a systemic issue which requires a systemic, multi-
factorial solution. That's what the President will be rolling 
out tomorrow, absolutely.

                         FAIR DRUG PRICING ACT

    Senator Baldwin. I sent a letter with Senator McCain to the 
President asking that he look at and support our Fair Drug 
Pricing Act. That requires basic transparency for drug 
companies when they plan to increase the price of their drugs. 
Will a component of the President's plan be a call for basic 
transparency for drug corporations particularly, but across 
that system generally?
    Secretary Azar. Senator, I'm sure you'll understand I'm not 
in a position to preempt the President of the United States 
tomorrow by saying what he will and won't announce. So I 
apologize, but I'm happy to get back to you after that and 
discuss the issue of transparency. But in terms of any 
particulars of the President's announcement, I'm afraid I do 
need to demure until tomorrow. My apologies, though.
    Senator Baldwin. Well, then we will follow up on that. I 
think for us as policymakers, that's one of the most key 
aspects, and certainly as we advocate on behalf of our 
constituents.

                        SHORT-TERM HEALTH PLANS

    I want to turn to the issue of the short-term health plans. 
During the partisan repeal debate last year, thousands and 
thousands of Wisconsinites called on Washington to protect 
their care. The Administration, in my opinion, continues to 
undermine and sabotage the Affordable Care Act and create more 
instability in the marketplace.
    That is what I view as a pretty radical proposal to expand 
the ability of companies to sell these skimpy short-term health 
plans that don't include basic consumer protections that are 
required, of course, in participation in the Affordable Care 
Act, particularly things like preexisting condition coverage, 
and they exclude basic health benefits like maternity care or 
substance abuse treatment.

                         PREEXISTING CONDITIONS

    I think some of my colleagues know that when I was a child 
I was branded with the label ``preexisting condition'' after a 
childhood illness, and my family couldn't find a health plan 
that would cover me. Your plan would take us back to those days 
by allowing more junk plans and for longer periods of time. One 
of those plans sold in Wisconsin today excludes coverage for 
preexisting conditions and refuses to cover non-emergency 
hospital services on the weekend.
    Do you believe that insurance companies should be allowed 
to deny coverage or charge more for those with preexisting 
conditions?

                       SHORT TERM INSURANCE PLANS

    Secretary Azar. So, these plans, which are only a 
compensation for the failure of the Affordable Care Act markets 
for those for whom it's not working, the 28 million people who 
do not have insurance because they've been shut out of that 
market, they can't afford what's there, we're trying to bring 
back something that President Obama had, which are these short-
term plans. People need to go in with their eyes open. They are 
not right for everybody. They will help in transitional cases. 
They might be available for those who cannot afford care. We're 
trying to just make more options available there. The Labor 
Department----
    Senator Baldwin. But you make them from 3 months to----
    Secretary Azar. To 12, exactly what President Obama had up 
until the eve of the end of his presidency. Twelve months is 
what is the proposal, just to restore what President Obama had 
the entirety of his presidency.
    Senator Baldwin. So this is, right now, 3 months.
    Secretary Azar. Three months he changed in October of 2016, 
reverted it to put it back to 3 rather than 12. It's an option. 
It's not meant to be the be-all and end-all. It's just for--
we're trying to help those forgotten men and women who are 
sitting there with any options we can make available to them.
    Senator Baldwin. Why don't you add a requirement that those 
cover preexisting conditions?
    Secretary Azar. Well, if we start making them the 
equivalent of the Affordable Care Act, we'll end up with the 
same pricing regimes. We'd be replicating that. We just want to 
make other options available for those for whom it makes sense. 
Again, we're being very transparent. These will not make sense, 
necessarily, for all people. It's for folks for whom it makes 
sense. We want to have options available and let them choose.
    Senator Blunt. Thank you, Mr. Secretary.
    Thank you, Senator Baldwin.
    Senator Hyde-Smith.
    Senator Hyde-Smith. Thank you, Mr. Chairman.
    And thank you, Secretary Azar, for testifying today.

                             RURAL AMERICA

    I'm from Brookhaven, a small town in southwest Mississippi, 
so I'm well aware of the challenges that a rural State presents 
in healthcare. But I was pleased to learn that the CMS recently 
released the agency's very first rural health strategy intended 
to improve the quality of life for Medicare beneficiaries who 
live in rural areas. So I thank you for working to ensure that 
the voices of rural patients and healthcare providers are 
heard, and when your department considers payment policies and 
regulations, also that consideration.
    Secretary Azar, can you discuss further how your fiscal 
year 2019 budget request will support health in rural America?
    Secretary Azar. Thank you very much, Senator, and it was a 
pleasure to meet you over the phone. Thank you for that.

                        COMMUNITY HEALTH CENTERS

    First, the budget has $5.1 billion for community health 
centers. The community health centers serve 1 in 12 Americans 
around the country, but in particular 86 million patients, 1 in 
6, living in rural areas. So our bipartisan support for the 
community health center program is, of course, vital to 
healthcare in the rural communities.
    We also, with the opioid epidemic, we've added something 
very novel in here, which is a $150 million program for opioid 
treatment focused in rural areas. And then, of course, we have 
the program that you mentioned that we've just laid out, the 
CMS rural health agenda. We have programs there, for instance, 
that would allow Medicare Advantage programs to deliver 
telehealth services and other services in a rural area more 
economically.
    I also want to look if you or others can identify where we 
have barriers in our payment regimes or regulations that impede 
alternative or innovative methods of care delivery in a rural 
setting. We know the issue in Mississippi of rural hospitals 
suffering and closing. Maybe traditional hospital models aren't 
the best way to deliver care or economically feasible. Are we 
getting in the way of the creativity of new models for 
delivering the kind of care that's needed in those communities?

                            RURAL PHYSICIANS

    Senator Hyde-Smith. Thank you. Also, rural America has 20 
percent of the population and 9 percent of physicians. When I 
was in the Mississippi legislature, we worked to establish the 
Mississippi Rural Physicians Scholarship Program to help 
address the shortage of physicians in the rural areas in the 
State, and it was a great benefit. We're still reaping those 
benefits today. But how does your budget request support 
physician workforce in rural places like Mississippi?
    Secretary Azar. So what we've tried to do is prioritize the 
programs that we believe work the best, especially in getting 
providers to go to underserved areas, and those are the 
scholarship and tuition reimbursement programs. As you look at, 
say, the HRSA (Health Resources and Services Administration) 
budget, our focus there is direct service care delivery, and 
then workforce training that is based on scholarship and 
tuition reimbursement. We just find that those programs deliver 
health professionals, and they also have service obligations 
connected to them that help us get people into remote areas, 
underserved areas, to be able to deliver, as opposed to the 
programs that we have that are, for instance, just more subsidy 
payments to institutions. The individual targeted ones, we 
think there are decades of evidence to show that those really 
do work in delivering. We want to focus in that space.
    Senator Hyde-Smith. Right. Thank you.
    Senator Blunt. Thank you, Senator Hyde-Smith.
    Senator Merkley.
    Senator Merkley. Thank you very much. I wanted to follow up 
on that question about physicians and the shortage, because it 
seems like we're all competing everywhere, our rural areas, our 
Veterans' Administration, as so many practitioners are Baby 
Boomers and retiring, and so many of us are Baby Boomers and we 
need more healthcare.

                   GRADUATE MEDICAL EDUCATION FUNDING

    So in that context, I was somewhat surprised at the $48 
million cut to graduate medical education, and also on the 
nursing program a $145 million cut for nursing workforce 
development. All I'm hearing from my medical community is we 
need to train more doctors and more nurses and more PAs, so why 
does it make sense to cut these programs?
    Secretary Azar. So, with regard to the second program that 
you mentioned, the nursing program, that would get to the 
comment I was just making around the types of programs. The 
ones that support scholarship tuition reimbursement that are 
individually focused we think really can deliver. The 
institutional subsidy ones, in a scarce environment, we think 
are less effective.
    In terms of graduate medical education, what we've proposed 
is to combine the children's graduate medical education, 
Medicare and Medicaid graduate medical education into a single 
program funded by general fund revenue rather than focused on 
Medicare and Medicaid. Of course, we all benefit from the 
training of these physicians and nurses through the GME 
program, and then allowing us to--right now, we're frozen in 
1996. This would give us flexibility to actually target 
specialties, as well as areas that most need GME (Graduate 
Medical Education) training.
    Senator Merkley. Because I have so little time, I'm going 
to cut you off there and just note that it appears that even 
when those are added together, there's less money for physician 
training, and there's a lot less money for nurse training. 
While providing grants to go to rural areas is something that 
benefits my rural areas, it doesn't increase the overall 
numbers, and that's the core problem. Otherwise, everyone is 
just competing for a pool that's way too small.

                           HEPATITIS B AND C

    Let me turn to hepatitis B and C. This is Hepatitis 
Awareness Month. I'm just going to keep this very short. 
There's been a big increase in hepatitis B and C. Are you aware 
of it, and will you support helping to take on this issue as 
we're here in this month when our attention is supposed to be 
focused on it?
    Secretary Azar. Absolutely, and so much of it is connected 
to this opioid epidemic. So we look forward to working with you 
on that.

                            MEDICARE FOR ALL

    Senator Merkley. It is very connected, absolutely.
    When you talked about the junk plans you said, well, it's 
nice to provide as many options to people as possible, let them 
choose their options. Well, why not let people choose Medicare 
as an option? Senator Chris Murphy and I and several of my 
colleagues have introduced a bill that says let people choose a 
Medicare policy if they want, a public option. We created a 
public option in Oregon under Worker's Comp that cut the cost 
in half. Rhode Island copied Oregon's model with a public 
option, cut the cost of care in half.
    So under your philosophy, why not allow a Choose Medicare 
option?
    Secretary Azar. The challenge with the Medicare for All 
type approach is that we already have sustainability issues for 
our senior citizens in Medicare, and we thought that----
    Senator Merkley. Okay, I'm just going to cut you off there, 
because this is a program separate from the existing pool for 
Medicare. This would be Medicare Part E, and it spends the 
money people spend on an exchange but lets them choose a better 
organized option that competes with the regular insurance 
options. If you're really for competition, why not support a 
public option? I certainly think that citizens--and we see this 
in polling--would overwhelmingly like to see that they could 
have this choice on the exchange, or enable their employers to 
be able to choose this.
    Secretary Azar. You're not going to be able to afford 
Medicare without a subsidy, and that would undermine already 
the fiscal sustainability of Medicare. We heavily subsidize 
Medicare----
    Senator Merkley. Just stop there, because you obviously 
haven't read the bill or you wouldn't say that, because this is 
a stand-alone competition on a level playing field parallel to 
the way we do it in Oregon for Workers Compensation. Take a 
look at it. Look for things that are market-based that actually 
work rather than undermining Medicare for all citizens across 
this country, as embedded in your current budget.

                          MEDICAID BLOCK GRANT

    And speaking of that, the Medicaid block grant strategy 
that you've laid out based on Graham-Cassidy, this would cut 
about $2,500 per recipient in Oregon. We have one of the lowest 
uninsured rates in the country, and you just referred to your 
concern about those who don't have insurance. We have a very 
low rate because we've really actively worked on Medicaid 
expansion, and it's helped everyone in rural Oregon, and urban, 
because the uncompensated care has dropped dramatically, 
meaning our clinics are thriving, or at least doing far better 
than in States that didn't expand Medicaid.
    I was just in a State that had three rural hospitals shut 
down because they didn't expand Medicaid and they didn't have 
the finances to go forward. So why go to a program that will 
produce the closing of rural clinics and rural hospitals 
desperately needed across America?
    Secretary Azar. So, the Affordable Care Act Medicaid 
expansion as it is, is an open-ended entitlement that is not 
going to be sustainable for us as taxpayers or for our 
government in the future, and what we try to do is focus that 
on the individuals who for now there is a significant 
disincentive towards the children, disabled, and the aged in 
Medicaid towards able-bodied adults through the expansion. It's 
financial. It's basic math in terms of the incentive structure 
of how the Affordable Care Act was structured. So we're trying 
to put Medicaid on a more sustainable path forward for 
taxpayers and for the future of the program.
    Senator Merkley. Sustainable means cutting healthcare for 
poor people and damaging rural America, and that's just 
unacceptable.
    Senator Blunt. Thank you, Senator Merkley. If you want to 
have a second round of questions, we'll have those.
    Senator Rubio.
    Senator Rubio. Thank you.
    Thank you, Mr. Secretary, for being here today. We got a 
chance to briefly talk about this, so I wanted to explore it 
further with you.

                           MADE IN CHINA 2025

    So, there's a program that China is undertaking. It's 
called Made in China 2025. The plan is to dominate the 10 
biggest technologies of the future. One of those 10 is the 
pharmaceutical industry, in particular biopharma. In fact, it 
was the second largest investment in China last year.
    And the way they do it is twofold. One is they block off 
their own market to foreign competition, and they do this in 
other industries. They're doing it now with biopharma. But the 
other is, frankly, they just steal intellectual property, and 
they do that through a number of methods, the foreign-domestic 
partnerships they require in the pharmaceutical industry. If 
you go do business in China, you have to partner with one of 
their companies. They have a track record of stealing 
intellectual property. Obviously, if you're not paying for the 
research and are benefitting from it, it's not just unfair and 
illegal, it's an incredible advantage.
    The other is they buy small companies, including here 
domestically, that have key research components of other 
industries. We should anticipate the same in pharmaceuticals.
    And the third, frankly, is they just steal it. They break 
into computers through a cyber attack, they buy a business, or 
they go after the researchers, and that's the part that I'm 
most concerned about. You know, we spend a lot of money through 
NIH to fund biomedical research, and a lot of that is done 
through universities, and I'm concerned about that because 
universities are soft targets, and they're soft targets for two 
reasons. First, universities don't think this way. They operate 
in collaborative environments with other people, and they're 
not used to an adversarial set-up that this proposes.
    But the other is I wonder whether they have the systems set 
up to protect themselves for intellectual property theft, and 
that could be ranging from cyber all the way to actually being 
able to identify individuals and partners they're working with 
who ultimately are really just transferring intellectual 
property back to a Chinese company or the Chinese government to 
give them a competitive advantage.
    I would just say that if their growth in this field and 
advances were being driven by better innovation, more 
investment and all these sorts of things, then it would be on 
us to become more innovative and invest more. But when a 
significant part of their advances on technology in general, 
and biomedicine in particular, is driven by intellectual 
property theft, I also believe this has significant national 
security implications for our country. I challenge people to 
think for a moment what the world would look like if the 
latest, greatest cures for diseases, including potentially 
things like Alzheimer's that are going to have a very 
significant impact on our budgets for years to come, were 
controlled by China, the amount of leverage that that would 
provide them geopolitically and the like.
    So I was curious whether anyone at these agencies is 
thinking about this, thinking about how to protect our 
research, knowing that this industry is the target of a nation 
with a long track record of stealing intellectual property.
    Secretary Azar. Senator, thank you very much for raising 
and highlighting what is a very important issue. It is one that 
is on our radar. It is one we are working, and I'd be happy to 
work with you offline also in appropriate settings to discuss 
this. But I think you have hit on a really quite important 
issue.

                         EMERGENCY PREPAREDNESS

    Senator Rubio. All right. The second question is more 
local, and it has to do with preparedness. During the 2017 
hurricane season, my office at one point became, in many ways, 
a triage center, largely centered on getting Federal agencies 
to communicate with each other and States. This was 
particularly problematic in Puerto Rico, where there were 
delays in getting supplies and HHS medical teams to the island. 
I want to say there were multiple occasions in which FEMA 
(Federal Emergency Management Agency) or the Department of 
Defense caused delays in being able to get HHS supplies to 
Puerto Rico.
    FEMA took days to approve flights for HHS medical teams and 
some medical supplies. They took a week, the DOD (Department of 
Defense) took a week to respond to the initial request for 
medical teams to Puerto Rico.
    Have we learned any lessons from Puerto Rico, from the 
hurricanes in 2017? Because I think this has applicability not 
just because we're entering hurricane season now, but I think 
this has applicability for natural disasters in the future or, 
quite frankly, biological attacks or any other mass public 
health threat we might face.
    Secretary Azar. Again, thank you for raising what is an 
issue very much on my radar. We actually just had a session 
with DOD and other interagency partners on lessons learned from 
the last season preparing for this, with a focus in particular 
on transportation resources and our ability to deploy, because 
we are, of course, often dependent on others for transport. So 
there is a major focus on lessons learned from the 
unprecedented cycle of hurricanes that really taxed our system, 
and I'm hopeful that we have systems worked out better, and 
connectivity even better, to make sure we serve our people 
well.
    Senator Rubio. Thank you.
    Senator Blunt. Senator Shaheen.
    Thank you, Senator Rubio.
    Senator Shaheen. Thank you, Mr. Chairman.
    Mr. Secretary, thank you for taking time to speak with me 
yesterday. I appreciated the call and the conversation.

                        OPIOID EPIDEMIC FUNDING

    As I told you, one of the biggest challenges we are 
grappling with in New Hampshire is the opioid epidemic and how 
to respond to that. I have been very concerned about making 
sure that the small States like New Hampshire, like West 
Virginia--I understand Senators Capito and Manchin asked about 
this--are able to get help because of the overdose rate, not 
just based on our population but because of the high overdose 
death rate. New Hampshire ranks third in the country right now, 
first when it comes to fentanyl overdoses, and we have 
additional impacts that are not felt in some of the bigger 
States.
    So I'm hoping that you will commit to working with me and 
with the committee to ensure that those States that are hardest 
hit by the epidemic, not just in terms of population but based 
on overdose death rate, will get some additional assistance to 
help us.
    Secretary Azar. Thank you for raising this important issue, 
and thank you for your leadership in the committee's work on 
this, because it has been a concern of ours, and we've heard 
that. In the coming grant cycle coming out of the omnibus, not 
only did the Congress give us a 15 percent set-aside for the 
hardest-hit States but in addition has given us the 
flexibility, which we intend to use, on the remainder of our 
grant programs to also target those based on the burden of this 
crisis.
    Senator Shaheen. And do you have any sense of when the 
decision will be made about that $142 million, which is the 
set-aside?
    Secretary Azar. I know generally the next round is expected 
in September, to get out in September. I don't know if, on the 
set-aside amount, if that's on a different timeline. I'd be 
happy to get back to you on that.
    Senator Shaheen. Thank you.

                              DRUG PRICING

    We also talked about drug pricing, which I think is a huge 
issue. It's not just an issue for families who can't afford 
drugs, particularly senior citizens, but also in terms of 
driving up the cost of healthcare.
    One of the issues that I'm most concerned about, having 
attended the Aging Committee hearing on the cost of insulin, is 
what's happening with the price of insulin. I don't know if you 
can see this. You can probably just see the trajectory of 
pricing, but this is insulin prices, this line, and we should 
have had it blown up.
    Mr. Chairman, can I ask that this be entered into the 
record?
    Senator Blunt. Without objection.
    [The information follows:]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    

    Senator Shaheen. But what it shows is that these insulin 
prices started going up dramatically in 2003, after we passed 
Medicare Part D. So clearly there is a correlation, or I 
believe there is a correlation between what's happening with 
the cost of insulin, and I'm sure other drug prices, and our 
failure to negotiate with pharmaceutical companies.
    But can you talk about what you can do at HHS to help 
address the cost of insulin? Which is not an option for people 
who need it; it's life or death.
    Secretary Azar. I'd like to, if I could, speak generally 
about what we need to do around the drug issue. First, in the 
budget proposal that we have in this fiscal year 2019 budget, 
we actually have a five-part plan that we would propose to 
Congress around restructuring many elements of the successful 
Part D drug program, but taking learnings from the last 15 
years, and I think you've highlighted one, which is the 
incentives in the system towards higher list price.
    Given that we as taxpayers sit at what's called the 
catastrophic period, at the end there, if the drug with its 
list price can march on through there and get to the 
catastrophic period, we the taxpayers bear 80 percent of that 
cost, and the drug plan only bears 15 percent of that. We've 
proposed to Congress to flip that around to give those drug 
plans more of an incentive to cram down those list prices. So 
that's an important part of what we're driving towards.
    Of course, tomorrow the President will lay out even more 
focused on these issues of list prices that you so rightly 
raised.
    Senator Shaheen. Well, thank you. I appreciate that and 
look forward to hearing the announcement.

                            TITLE X FUNDING

    HHS recently issued a funding opportunity announcement for 
Title X family planning grant dollars that really alters the 
focus from selection of grantees who have focused on 
contraceptive care towards abstinence-only approaches. Now, we 
have the lowest teen pregnancy rate ever in this country's 
history right now, and most of the data that I've seen indicate 
that that's because we have focused on contraceptive care, on 
access to reproductive healthcare for not just young people but 
for everyone.
    So I don't understand why we are fooling around with 
something that's been working to address the issue of unplanned 
pregnancy, and particularly teen pregnancy, to focus on an 
approach that all of the data that I've seen shows doesn't 
work.
    Secretary Azar. Senator, in the funding announcement that 
we did there, the intention was to comply with the statutes, 
the mandate of a broad range of family planning services, so 
not just contraception but natural family planning, which is, 
in fact, called out expressly in the statute. So not meant to 
favor one over the other but ensure the broad range of 
availability, streamline our grant-making processes to make it 
more efficient. So the intention there is a broad range of 
providers, as well as serve the full range of services that 
Title X asks us to provide.
    Senator Shaheen. Thank you. I have a follow-up, but I'll do 
that for the record.
    Thank you, Mr. Chairman.
    Senator Blunt. Thank you, Senator Shaheen. If you want to 
ask your question in a second--well, go ahead and ask it right 
now.
    Senator Shaheen. Well, again, do I misunderstand when I 
look at this funding opportunity announcement? As I said, my 
interpretation is that it focuses more on abstinence-only 
approaches. Do I misunderstand?
    Secretary Azar. It offers natural family planning as one 
part of comprehensive or a broad range of family planning but 
doesn't set aside, I don't believe, or preference one over the 
other but rather has the full range of availability and says 
that if a provider wishes to provide in the one category, they 
can. But there's nothing that says that one is disadvantaged by 
providing in the non-natural family planning, the contraceptive 
type arena. So I think it's meant to encourage the broad range, 
which is exactly the language of Title X, the broad range of 
family planning services. So I believe it's meant to be 
ecumenical, agnostic.
    Senator Blunt. I think there will be follow-up questions, 
obviously, for the record. Let me mention a handful of them 
that I'm going to be asking to make sure that both you and our 
staff know I want to ask these questions, at least. There will 
be other questions to be asked.
    I would suggest that I believe our communication has gotten 
better under your leadership. I think it can always be better, 
and hopefully we continue to do that.

                         UNACCOMPANIED CHILDREN

    On the unaccompanied children issue, I'm not comfortable 
with what we know from the Department. So if you can help us 
with information so we can have a little more ability to think 
about that and plan that.

                            RECOVERY AUDITS

    We'll be asking a question about the recovery audits. I 
know the U.S. District Court recently ruled that HHS needs to 
pay the backlog of claims by 2021, which is important because 
particularly small and rural hospitals generally can't afford 
to have a staff of auditors and lawyers fight these. The longer 
they stay in this line and don't get their issue decided, the 
more challenging it is for them. I know your budget requests an 
additional $70 million for this purpose. One of the questions 
will be whether you think that actually meets the court 
deadline that by the end of 2020 everybody currently in this 
long list of recovery audits is going to have their situation 
dealt with.

                             MENTAL HEALTH

    Also, on the mental health side, I would hope that you 
continue to look at excellence in mental health, this eight-
State pilot, and determine how that can become, if the pilot 
produces what I believe it will, how that can become a part of 
our future policy and our future funding for treating mental 
health like all other health.

                       BEHAVIORAL HEALTH CLINICS

    We have a certified community new investment of $100 
million for behavioral health clinics to provide treatment for 
Americans that suffer on a clinic and community basis where 
they can ask for part of that $100 million. That's a new 
program, but we'll be asking to see if that program is working.

                             HHS TRANSFERS

    On another topic of transferring responsibilities to NIH, I 
would just say that one of us is not understanding the 
discussion here. We have the same request as last year to 
transfer a bunch of things like National Institute of 
Occupational Safety and Health, the National Institute of 
Independent Living and Rehabilitation Research to NIH. It's 
been the view of the committee that NIH has enough to do, and 
that's a priority, and those other things bog them down. We 
probably need to be sure we understand your argument on the 
transfer. It's the second time you've made it. Let's see that 
we give you a chance to make that case.
    So from me and the committee you'll get those and other 
questions.
    Senator Murray.
    Senator Murray. Thank you very much, Mr. Chairman. Let me 
just make comments on two things, and I do have one more 
question for you.

                       TEEN PREGNANCY PREVENTION

    On the teen pregnancy prevention program Senator Shaheen 
referenced, actually I was in Washington State a couple of 
weeks ago and I spoke to the Director of the King County Public 
Health Department. They operate a program called FLASH. It's 
the Family Life and Sexual Health program. It was one of the 
previous TPP grantees whose funding was terminated by your 
office in the middle of their 5-year grant. My understanding is 
that widespread use of the FLASH curriculum has had really 
great results. The teen birthrate in King County fell by 63 
percent since 2008, and despite that, your office terminated 
it.
    I just want you to know that you're effectively throwing 
away really valuable data that these grantees have collected 
over the past 3 years that could really help us inform 
pregnancy prevention. Actually, I want you to know, too, that 
the bipartisan Commission on Evidence-Based Policymaking, which 
was established by myself and Speaker Paul Ryan, highlighted 
the TPP program, Teen Pregnancy Prevention, as an example of a 
Federal program developing increasingly rigorous portfolios of 
evidence.
    So I know this is a subject of litigation right now in 
terms of our grantee and you can't comment, but I will continue 
to follow this, and I'm really concerned that we're throwing 
away valuable research with the changes you proposed.

                           MATERNAL MORTALITY

    The other issue I just want to highlight for you is 
maternal mortality. I am really troubled that greater 
proportions of women in this country are now dying of 
pregnancy-related complications, more than any other developed 
country in the world, and the U.S. is the only country where 
the rate of these deaths has been rising. That is really 
troubling to me, and it is just so critical that we improve 
systems of maternity care, including both clinical and public 
health systems. We've got to work on eliminating this really 
preventable maternal mortality and severe morbidity rate that 
we're seeing across the country, so I will be talking with you 
about that.

                         GUN VIOLENCE RESEARCH

    And then I do have one final question, and that is on gun 
violence research. The last time you and I spoke and met, we 
talked about the Centers for Disease Control and Prevention 
reengaging in gun violence research. I've spoken with Dr. 
Redfield, the new CDC Director, about that, and since then 
Kaiser Permanente actually announced it will invest $2 million 
to start working on this issue, along with a group of seven 
bipartisan governors who launched a consortium to study it. 
That just reinforced for me that it's time for CDC to return to 
do the same.
    Dr. Redfield actually had the best quote. He said, ``The 
CDC is the best science-based, data-driven agency in the world. 
We should be using them.''
    So I wanted to ask you, do you intend to--actually, can you 
reprogram or transfer funds today from HHS to CDC to begin this 
work?
    Secretary Azar. I don't know about that, but I've spoken to 
Dr. Redfield, as I had previously with Dr. Shulkin, to make 
clear our understanding of the Dickey Amendment, which is that 
we're not prevented from using appropriated funds if we 
appropriated funds for research on violence, including gun 
violence research. We do that at NIH today. We've got ongoing 
programs and past programs on violence and gun violence 
research at NIH, as you know, because you appropriated the 
money. NIH's pools of money are much more fluid and open for 
peer-reviewed funding of programs. But CDC is not that way. We 
are very directed in where the money goes there.
    Senator Murray. But can't you reprogram? If this is a 
priority for you, I believe that you can reprogram or transfer 
funds directly for this reason.
    Secretary Azar. I'm not aware. I'd have to look into that.
    Senator Murray. Okay. If you could do that and get back to 
me?
    Secretary Azar. Will do.
    Senator Murray. Or I'll ask you, are you intending to 
include gun violence research funding in your next budget 
submission?
    Secretary Azar. That would be a matter between the 
Department and OMB on the budget submissions. I couldn't 
comment on where we will be as an administration on the 
funding.
    Senator Murray. Well, as Secretary, would you be willing to 
ask for that in the next budget?
    Secretary Azar. Again, I cannot reveal my deliberative work 
with the White House on that.
    Senator Murray. Okay. Let me say, would you please look at 
that as a priority?
    Secretary Azar. I absolutely appreciate your concern there. 
Thank you.
    Senator Murray. Thank you.
    Senator Blunt. Thank you, Senator Murray.
    And thank you, Mr. Secretary, for being here.

                     ADDITIONAL COMMITTEE QUESTIONS

    The record will stay open for one week for additional 
questions.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]
                Questions Submitted by Senator Roy Blunt
                      national institute of health
    Question. Last year, the budget proposed moving the Agency for 
Healthcare Research and Quality to the NIH. That proposal was rejected. 
This year, the budget once again proposes this move, as well as also 
moving the National Institute of Occupational Safety and Health and the 
National Institute of Independent Living and Rehabilitation Research to 
NIH. I am concerned that the addition of these new Institutes takes NIH 
out of its defined role as a biomedical research agency. The budget 
proposal appears to have taken any ``research'' related organization 
and moved it to the NIH. I do not think that is in the best interest of 
NIH.
    What is the goal of these moves?
    Answer. The goal of consolidating targeted research programs from 
across HHS--AHRQ/NIRSQ, NIOSH (from CDC), NIDILRR (from ACL)--into NIH 
is to focus resources on the highest priority research so these 
programs benefit from the NIH research infrastructure, which we 
anticipate will improve coordination and outcomes. NIH will continue to 
implement strategies to increase operational efficiencies and 
administrative reforms.
    Question. What are the benefits to NIH in adding these new centers?
    Answer. The fiscal year 2019 Budget proposes consolidating HHS 
research programs into three new institutes within the NIH. The Budget 
provides $256 million for the activities of the Agency for Healthcare 
Research and Quality (AHRQ), consolidated into the National Institute 
for Research on Safety and Quality. The National Institute for 
Occupational Safety and Health (NIOSH), including the Energy Employees 
Occupational Illness Program (EEOCIPA), currently administered by the 
Centers for Disease Control and Prevention, and the National Institute 
on Disability, Independent Living, and Rehabilitation Research 
(NIDILRR), currently administered by the Administration for Community 
Living, are also proposed for consolidation into the NIH.
    Consolidating targeted research programs from across HHS--AHRQ/
NIRSQ, NIOSH, NIDILRR--into NIH allows high priority research programs 
to benefit from focused resources and NIH research infrastructure, 
which we anticipate will improve coordination and outcomes. NIH will 
continue to implement strategies to increase operational efficiencies 
and administrative reforms.
                  unaccompanied alien children program
    Question. The Department of Justice recently announced it would 
criminally prosecute all undocumented individuals apprehended 
attempting to enter the country illegally between points of entry. How 
many children does the Administration expect will be referred to HHS as 
a result of this policy change?
    Answer. HHS is closely working with our DHS partners to anticipate 
and plan for the potential number of unaccompanied alien children (UAC) 
referrals and their length of stay in our care. Historically, the 
timing and number of UAC referred to HHS each year for care and custody 
has been difficult to predict with any certainty and we assess need for 
capacity growth or decline on an ongoing basis.
    Question. What if any preparations has HHS made to properly care 
for additional children referred to them as a result of this policy 
change?
    Answer. When there are concerns about having adequate capacity to 
receive referrals of unaccompanied alien children, HHS seeks out 
additional bed space to meet increased demand. HHS first expands the 
number of beds available with existing state licensed grantee care 
provider facilities. If necessary, HHS seeks bed space with a state 
licensed facility that is not currently housing UAC. In the event of an 
influx, defined as a period where the number of UACs exceeds the 
standard capabilities of Federal agencies to process, transport, or 
shelter with existing resources, HHS may open a temporary emergency 
shelter, which we call an Influx Care Facility. During recent months, 
HHS has taken all of these steps, adding over 2,300 beds since early 
May by increasing bed capacity at permanent grantee shelters, expanding 
the temporary shelter in Homestead, FL, and seeking additional capacity 
at a temporary influx site.
    Question. HHS and DHS recently signed a Memorandum of Agreement 
(MOA) modifying existing data collection and sharing procedures related 
to reviewing the suitability of potential sponsors. DHS also recently 
issued a proposed regulation on the same issue. How does HHS expect 
this MOA to impact HHS' administration of the UAC program?
    Answer. Some changes will be made related to information gathering 
and sharing to implement the MOA between HHS and DHS. HHS has created 
new policies and procedures as a result. We will receive from DHS more 
detailed information about UAC that will enable HHS to better respond 
to gang affiliation. We also believe that the partnership with DHS will 
enable HHS to conduct improved background checks of potential sponsors 
to support our efforts to ensure the well-being of UAC when they are 
released from our care.
    Question. Does HHS expect this will increase the length of time 
children are in HHS' custody?
    Answer. The implementation of the MOA is still in the early stages, 
so its impact on the length of time children are in HHS' custody is 
unclear at this time. If the length-of-stay did increase, one factor 
would be the result of HHS receiving more comprehensive information 
related to ensuring sponsor suitability and the safety of UACs.
    Question. Regarding both policy changes described above, does HHS 
have any revised estimates of funding needs for the UAC program in 
fiscal year 2018 or fiscal year 2019, relative to fiscal year 2018 
enacted appropriations and the fiscal year 2019 budget request?
    Answer. HHS is closely monitoring its shelter capacity needs in 
coordination with our interagency partners, evaluating its resource 
needs and, if necessary, will seek to maximize currently available 
resources and authorities. As always, we will continue to work with 
Congress as we learn more.
                            coldwater creek
    Question. The community in St. Louis, particularly those near the 
Coldwater Creek area, have been waiting for a report to be released by 
the Agency for Toxic Substances and Disease Registry. This report will 
assess whether hazardous materials such as radioactive waste and other 
chemicals have migrated from storage sites into the Coldwater Creek 
area. ATSDR originally expected to file a final assessment in 2016, but 
have yet to receive a report. I am concerned this report is 2 years 
delayed and want to ensure it is provided quickly.
    Will HHS commit to issuing this report this summer?
    Answer. HHS is committed to releasing the report on Coldwater Creek 
as soon as we can practically do so. The report currently in the final 
stages of scientific review with CDC/ATSDR's standard process. ATSDR 
has been working closely with the community in St. Louis to inform them 
of its work to assess exposures to radiation contamination at Coldwater 
Creek. We recognize the importance of the assessment to the community 
members and we want to make sure it is as accurate and thorough as 
possible. The report will be posted on the ATSDR website for comment 
once it has completed the scientific clearance process.
                            medicare appeals
    Question. HHS has been working for years to reduce the backlog of 
Medicare appeals, but continues to project a backlog of over 500,000 
appeals. What will be the impact of the additional $75 million provided 
in the fiscal year 2018 Omnibus?
    Answer. The additional $75 million provided in the fiscal year 2018 
Omnibus will help OMHA expand its adjudication capacity by acquiring 
additional ALJ teams to hear currently pending and newly filed appeals. 
When fully staffed in fiscal year 2019, OMHA will have approximately 
170 ALJ teams with the ability to adjudicate approximately 170,000 
appeals annually. In fiscal year 2019, HHS projects receipts at OMHA to 
exceed 100,000 appeals and continuing to rise in subsequent years. The 
fiscal year 2018 Omnibus funding level will finally allow OMHA to 
steadily adjudicate pending cases. At this level, OMHA projects to 
eliminate the backlog in approximately 7 years.
    Question. How has HHS created a more consistent process at the 
Office of Medicare Hearings and Appeals to discourage continued 
appeals?
    Answer. OMHA has implemented a number of measures to improve and 
expedite the appeals process. OMHA has established a National 
Substantive Legal Training Program for new ALJs and attorneys, with 
yearly judicial education to increase consistency in decisionmaking and 
address program integrity issues. Regulations effective March 20, 2017 
have expanded OMHA's ability to process Level 3 appeals by providing 
for review of certain appeals by attorney adjudicators rather than 
ALJs, implemented processing efficiencies at OMHA, and resolved many 
areas of confusion among stakeholders. In addition, beneficiary appeals 
have been prioritized to optimize timely adjudication. The OMHA Case 
Processing Manual (OCPM) initiative is establishing OMHA-wide common 
business practices for the adjudicative process, and OMHA is using 
strategic case assignments to assign appellants with a large number of 
filings to a single ALJ, facilitating potential consolidated 
proceedings and more efficient adjudication. These ``big box'' 
assignments are then rotated among ALJs in accordance with the 
Administrative Procedure Act. OMHA has a Statistical Sampling Pilot to 
resolve large groups of appeals, and its Settlement Conference 
Facilitation initiative is providing a less costly alternative to ALJ 
hearings. Thanks to these efforts, and CMS's efforts implemented at 
appeal levels 1 and 2, the Department has seen a drop in OMHA's annual 
receipt levels since the peak in fiscal year 2014 which saw OMHA 
receive over 470,000 appeals in 1 year.
    Question. Your budget requests an additional $70 million over 
fiscal year 2018 to work through the backlog of appeals. If this 
request is appropriated, how quickly will the backlog be reduced?
    Answer. HHS projects that, with current administrative actions in 
place, the fiscal year 2018 funding, and additional resources and 
authorities requested in fiscal year 2019, once OMHA is fully staffed, 
the backlog could be eliminated in approximately 4 years.
    In addition, the fiscal year 2019 President's Budget and the Audit 
& Appeals Fairness, Integrity, and Reforms in Medicare Act of 2015 
(AFIRM), introduced by the Senate Finance Committee, propose additional 
authorities that would be useful in reducing the pending backlog of 
Medicare Appeals more efficiently, and allow for future receipts to be 
addressed at lower levels. These authorities include changing the 
Medicare Appeal Council's standard of review; remanding appeals to the 
redetermination level with the introduction of new evidence; increasing 
the minimum amount in controversy for Administrative Law Judge (ALJ) 
adjudication of claims to equal the amount required for judicial 
review; establishing magistrate adjudication for claims with amounts in 
controversy below the new ALJ amount in controversy threshold; 
expediting procedures for claims with no material fact in dispute; 
limiting appeals when no documentation is submitted; requiring a good-
faith attestation on all appeals; and establishing a post-adjudication 
user fee for unfavorable appeals at the third and fourth levels of 
appeal. With fiscal year 2018 Omnibus funding, the Department's current 
administrative actions, and these authorities in place, the Medicare 
Appeals process will be better structured to encourage resolution of 
cases earlier in the process and resolving a greater volume of appeals.
                             mental health
    Question. The fiscal year 2018 Omnibus included a new investment of 
$100 million for Behavioral Health Clinics to provide treatment to 
Americans that suffer from mental illness, particularly in areas 
impacted by the opioid crisis.
    The fiscal year 2018 Omnibus included a new investment of $100 
million for Behavioral Health Clinics to provide treatment to Americans 
that suffer from mental illness, particularly in areas impacted by the 
opioid crisis. How will these funds help those with mental illness 
receive treatment and when does HHS expect grants awards to be 
announced?
    Answer. The purpose of this program is to increase access to and 
improve the quality of community behavioral health services through the 
expansion of Certified Community Behavioral Health Clinics. The CCBHC 
Expansion grant program will provide access to services for individuals 
with serious mental illness (SMI) or substance use disorders (SUD), 
including opioid disorders; children and adolescents with serious 
emotional disturbance (SED); and individuals with co-occurring 
disorders (COD). SAMHSA expects that this program will improve the 
behavioral health of individuals across the nation by providing 
comprehensive community-based mental and substance use disorder 
services; treatment of co-occurring disorders; advance the integration 
of behavioral health with physical healthcare; assimilate and utilize 
evidence-based practices on a more consistent basis, and promote 
improved access to high quality care. CCBHCs provide a comprehensive 
collection of services that create access, stabilize people in crisis, 
and provide the needed treatment and recovery support services for 
those with the most serious and complex mental and substance use 
disorders. CCBHCs integrate additional services to ensure an approach 
to healthcare that emphasizes recovery, wellness, trauma-informed care, 
and physical-behavioral health integration. CCBHCs provide services to 
any individual, regardless of their ability to pay or their place of 
residence. Data is currently being collected on the program to gauge 
effectiveness and identify lessons learned. Grants will be awarded by 
September 30, 2018.
    Question. When does HHS expect to report preliminary and final 
results of the current Excellence in Mental Health pilot program?
    Answer. SAMHSA is responsible for producing an annual report to 
Congress in December of each year, until 2021. The reports will be 
based on an ongoing evaluation overseen by ASPE, drawing on multiple 
data sources including state reported quality measures, clinic cost 
reports, site visits, clinic progress reports and telephone interviews. 
In order to measure the impact of the program on utilization patterns 
and costs of a full range of mental health services compared to 
Medicaid beneficiaries with similar demographic and diagnostic 
conditions who do not receive CCBHC services during the demonstration, 
Medicaid claims data from four states will be used. This quantitative 
portion of the evaluation will examine changes in inpatient, 
outpatient, and emergency care for both physical and behavioral health 
conditions for four states with the strongest data and comparison 
groups. Because of the lag in the availability of the claims data we do 
not anticipate that all of the necessary data will all be available for 
analysis until at least 2 years after the second year of the pilot 
ends. As a result, the report on these impacts will be available in the 
final report in December, 2021. The remainder of the reports to 
Congress will utilize primarily qualitative data, and report on cost 
and quality measures as soon as they are available. A summary of the 
planned report content is highlighted below:
  --The first Report to Congress should be out shortly, and focuses on 
        the characteristics of state delivery systems and CCBHCs at the 
        beginning of the demonstration, planned partnerships, and plans 
        for service provision, including whether CCBHCs had to change 
        services or provide new services. The report will also discuss 
        state plans for monitoring the quality of CCBHC services, as 
        well as which PPS model the state selected.
  --The second Report to Congress, due in December, 2018, focuses on 
        how well CCBHCs established relationships with other providers, 
        including formal relationships. It discusses how well they were 
        able to bill and generate claims and encounter data, what types 
        of services and evidence-based practices are being implemented, 
        and whether they are using telehealth or other providing 
        services in other locations. It will also discuss care 
        coordination practices, staffing patterns, and staff training.
  --The third Report to Congress, due in December, 2019, will focus on 
        whether the CCBHCs sustained their partnerships and delivery of 
        required services, including whether they maintained staffing 
        levels and training. It will discuss information sharing 
        practices across providers to coordinate care, as well as the 
        use of evidence-based practices. Because the first year of the 
        demonstration quality measures and cost reports will be 
        available in time for this report, the report will also discuss 
        CCBHC performance on quality measures and whether CCBHCs used 
        the quality measures to improve care. The cost reports will 
        allow the report to address what the costs of care were, and 
        whether they deviated from expectations. It will also report on 
        whether states changed the payment rates based on the first 
        year of the demonstration's costs.
  --The four Report to Congress, due in December, 2020, will focus on 
        changes in the quality measures over the course of the 
        demonstration, as well as changes in costs, utilizing both 
        years of cost and quality data. It will investigate whether the 
        costs and performance data vary by state, depending on the 
        prospective payment used. It will also investigate whether 
        quality bonus payments were made to clinics.
  --The final Report to Congress, due in December, 2021, will include 
        information on service utilization patterns and costs of 
        Medicaid beneficiaries in the CCBHCs compared to a comparison 
        group. It will also summarize the findings of the previous 
        reports, and provide recommendations concerning whether the 
        demonstration program should be continued, expanded, modified 
        or terminated.
                      strategic national stockpile
    Question. I appreciate the Department's continued communication as 
HHS works to shift the Strategic National Stockpile (SNS) from CDC to 
ASPR.
    How will HHS continue to rely on CDC expertise when deciding the 
necessary products to purchase for the stockpile?
    Answer. CDC participates in and provides subject matter expertise 
to the ASPR-led Public Health Emergency Medical Countermeasures 
Enterprise (PHEMCE), which HHS created to provide a venue for sharing 
information across agencies with a role in medical countermeasures. CDC 
will remain an active participant in PHEMCE workgroups and committees 
as a forum to ensure important clinical, regulatory, laboratory, and 
scientific input is accounted for in decisions related to the life 
cycle of SNS products. ASPR has committed to continue to fund in fiscal 
year 2019 most of the subject matter expertise at CDC that has been 
providing support to SNS activities.
    Further, to continue to increase collaboration across the 
Department, ASPR requested, and CDC has assigned, a senior CDC staff 
member to work as a liaison within the ASPR Immediate Office. 
Additionally, ASPR is identifying an ASPR employee to serve as a 
liaison at CDC in Atlanta.
    Continued inclusion of CDC in PHEMCE ensures that CDC's scientific, 
epidemiological, clinical, and public health expertise helps inform 
decisionmaking related to Medical Countermeasures (MCMs), such as 
requirement setting and acquisition of MCMs for the Strategic National 
Stockpile, which can be most effectively used to significantly reduce 
morbidity and mortality from public health emergency threats. CDC 
expertise is also important to help inform the practical requirements 
of dispensing MCMs by public health departments, monitoring use of 
MCMs, and assessing MCM use. CDC also maintains strong partnerships and 
trust with State, Local, Tribal, and Territorial (SLTT) public health 
entities and clinicians, who serve as some of the frontline providers 
for MCMs. While the SNS transitions to ASPR management, CDC will 
continue to provide this expertise through the PHEMCE and the SNS 
annual review process.
    Question. Does HHS plan to keep any SNS related funding within CDC 
to cover CDC's ongoing SNS costs?
    Answer. In order to ensure a smooth transition with no degradation 
of operational capability, ASPR and CDC have set up several joint SNS 
transition workgroups to evaluate all aspects of this program 
transition. Ensuring CDC's continued ability to provide, in a 
collaborative and transparent fashion, scientific, clinical, 
regulatory, laboratory, and SLTT coordination expertise will be a 
critical component to ensuring the ongoing successful operations of the 
SNS. While some details are still under review, ASPR has committed to 
fund transition activities to meet costs CDC may incur related to the 
SNS itself. Once finalized, HHS would be pleased to provide a full 
briefing for Committee staff on the SNS transition details before the 
end of the fiscal year.
                                 ______
                                 
               Question Submitted by Senator Marco Rubio
    Question. CMS recently proposed a rule for 2019 Medicare hospital 
payments. This proposal mentioned revising the Medicare payments for 
the cutting edge immunotherapies, known as CAR-T therapy. Oncology 
drugs are often administered on an outpatient basis, but these new CAR-
T therapies must be given on an inpatient setting. Yet, the costs of 
these drugs are only really covered by CMS if administered on an 
outpatient basis.
    CMS' recent IPPS proposal would not go into effect until 2019, yet 
Moffitt Cancer Center is one of two NCI-designated cancer centers that 
is capable of administering both of these breakthrough CAR-T 
treatments. Because of Moffitt's commitment to patients, they are 
absorbing the difference between the price of the drug, which is either 
$373,000 or $475,000, and the $20,000 that Medicare reimburses. But 
Moffitt cannot do this forever.
    Would you be willing to work with cancer centers like Moffitt to 
address the reimbursement shortfalls that are taking place through 
2018, before CMS' proposed payment reforms go into effect?
    Answer. HHS/CMS is considering the potential challenges in Medicare 
payment structures for new treatments like CAR-T therapies. Two CAR T-
cell therapy drugs received FDA approval in 2017--Novartis's Kymriah 
and Kite Pharma's Yescarta. For Medicare, CAR-T therapy is paid for use 
in the hospital outpatient setting under the Outpatient Prospective 
Payment System (OPPS), and in the hospital inpatient setting under the 
Inpatient Prospective Payment System (IPPS).
    In the hospital outpatient setting, effective April 1, 2018, both 
Kymriah and Yescarta have been approved for transitional pass-through 
payment status under the OPPS. Drugs under pass-through status are 
generally paid at average sales price plus 6 percent.
    Under the IPPS, payment for CAR-T is currently bundled into the 
Medicare payment for the inpatient stay and thus there is no separate 
CAR-T payment rate. In the fiscal year 2019 Medicare IPPS proposed 
rule, CMS proposed the assignment of CAR-T related procedure codes to 
the bone marrow transplant diagnosis related group. CMS also invited 
comments on alternative approaches to establishing payments for fiscal 
year 2019.
    CMS has received applications for IPPS new technology add-on 
payments for Kymriah and Yescarta for fiscal year 2019. It is also 
seeking public comment on these applications in the fiscal year 2019 
IPPS proposed rule. Under the new technology add-on payment policy, one 
of the criteria for an additional payment is that the technology 
represents an advance in medical technology that substantially 
improves, relative to technologies previously available, the diagnosis 
or treatment of Medicare beneficiaries. The deadline for submitting 
comments on the fiscal year 2019 IPPS proposed rule is June 25.
    However, because Moffitt Cancer Hospital is a PPS-Exempt Cancer 
Hospital it is generally paid based on reported cost and not under the 
Inpatient Prospective Payment System.
                                 ______
                                 
              Questions Submitted by Senator Patty Murray
                           maternal mortality
    Question. It is deeply troubled that greater proportions of women 
in this country are dying of pregnancy-related complications than in 
any other developed country in the world, and the U.S. is the only 
country where the rate of these deaths has been has been rising. It is 
essential that we improve systems of maternity care, including both 
clinical and public health systems, to eliminate preventable maternal 
mortality and severe morbidity across the United States.
    What can HHS do to reverse the rising rates of maternal death, and 
what will it take for the Department to take greater leadership to 
address this issue?
    Answer. Since 2016, CDC has collaborated with CDC Foundation and 
the Association of Maternal Child Health Programs on a project to help 
state-based maternal mortality review committees (MMRCs) produce 
stronger data on maternal mortality. These data can be used to better 
understand and prevent maternal mortality. The project also works to 
foster information sharing between MMRCs.
    To support this effort, CDC developed the Maternal Mortality Review 
Information Application (MMRIA). MMRIA facilitates case abstraction to 
help MMRC members to (1) understand the story of a woman's life and the 
events leading to her death and (2) support routine analyses to inform 
prevention, and (3) share a common language that helps MMRCs to 
collaborate with each other in case review and reporting.
    Through this work, a Report from Nine Maternal Mortality Review 
Committees was released in February 2018. The report found that about 
60 percent of pregnancy-related deaths are preventable and highlighted 
key opportunities for prevention. Additional key findings include:
  --Nearly half of all pregnancy-related deaths were caused by 
        hemorrhage, cardiovascular and coronary conditions, 
        cardiomyopathy or infection.
  --Mental health conditions are a leading cause of death, and also an 
        important contributor.
  --Deaths from hemorrhage, cardiovascular conditions and preeclampsia/
        eclampsia are highly preventable.
  --The leading causes of maternal deaths vary by race. For example, 12 
        percent of maternal deaths among black women are due to 
        preeclampsia or related conditions, compared to only 5 percent 
        of white maternal deaths.
    CDC has invested in Perinatal Quality Collaboratives (PQCs) to 
improve outcomes for mothers and infants. PQCs are state networks of 
teams working on quality improvement. PQC members identify healthcare 
processes that need to be improved and use the best available methods 
to make changes as quickly as possible. PQCs have contributed to 
important improvements in healthcare and outcomes for mothers and 
babies, including reducing deliveries before 39 weeks of pregnancy 
without a medical reason and reducing severe pregnancy complications. 
As MMRCs have increased capacity, PQCs can work with them to address 
the prevention recommendations that emerge from the Review Committee 
process. CDC currently supports PQCs in 13 States (Colorado, Delaware, 
Florida, Georgia, Illinois, Louisiana, Massachusetts, Minnesota, 
Mississippi, New Jersey, New York, Oregon and Wisconsin). to improve 
population outcomes in maternal and child health.
    Question. Does HHS support increased investment in successful 
evidence-based programs to prevent maternal deaths, such as the Safe 
Motherhood Initiative, or the Alliance for Innovation in Maternal 
Health and Healthy Start?
    Answer. HRSA is committed to supporting continued investments in 
evidence-based strategies to prevent maternal deaths and leverages 
existing resources and programs to address this important issue. For 
example, earlier this year HRSA released a notice of funding 
opportunity for the Alliance for Innovation on Maternal Health 
Initiative. The goals of this award will be to facilitate widespread 
implementation of the current maternal safety bundles and/or resources 
by maintaining the existing 10 AIM state-based teams, and accepting 25 
new state-based teams; develop new maternal safety bundles and/or 
resources that address new topics in the quality and safety of 
maternity care practices; develop and implement a national campaign 
focused on the current state of maternal mortality and severe maternal 
morbidity that highlights the impact of AIM, and how the maternal 
safety bundles improve maternity care practices; and prevent 1,000 
maternal deaths and 100,000 cases of severe maternal morbidity in the 
United States by 2023. An award announcement will be made before the 
end of fiscal year 2018.
    HRSA also continues to support the Healthy Start program, which 
currently funds 100 competitive grants in 37 States and DC to reduce 
disparities in infant mortality and improve perinatal outcomes for 
women and children in high-risk communities throughout the nation. 
Healthy Start aims to reduce these disparities by empowering high-risk 
women and their families to identify and access needed services to 
improve the health of mothers and children before, during, and after 
pregnancy. The Healthy Start program will be recompeted in fiscal year 
2019 and will serve women and families across the nation through 
approximately 100 new grants. Prevention of maternal deaths remains a 
priority. HRSA plans to incorporate recommendations from the Maternal 
Mortality Summit in future HSRA activities on maternal mortality and 
will continue to explore opportunities to utilize existing resources to 
support evidence-based programs to address this important public health 
issue.
    In addition, HHS supports continued resources for the Safe 
Motherhood Initiative to support Maternal Mortality Review Committees 
to increase access to robust, accurate data gathered through a 
standardized approach that can inform strategic, data-driven actions to 
prevent maternal mortality.
    Question. Is the Department taking action to address the 
disparities that women of color face when it comes to maternal 
mortality? What steps are being taken?
    Answer. Considerable racial disparities exist with respect to 
maternal mortality, with black women almost 4 times more likely to die 
from pregnancy-related complications than white women. CDC is working 
to better understand the disparities through better data. Data from the 
Building U.S. Capacity Project Report from Nine Maternal Mortality 
Review Committees was released in February 2018 including important 
data to begin to better understand the disparities in maternal 
mortality. This report found that the leading underlying causes of 
death varied between non-Hispanic white and non-Hispanic black 
pregnancy-related deaths.
    Among non-Hispanic white pregnancy-related deaths, the leading 
underlying causes of death were:
  1. Cardiovascular and coronary conditions (at 15.5 percent),
  2. Hemorrhage (at 14.4 percent),
  3. Infection (at 13.4 percent),
  4. Mental health conditions (at 11.3 percent), and
  5. Cardiomyopathy (at 10.3 percent).
    These top five causes represent 64.9 percent of non-Hispanic white 
pregnancy-related deaths.
    Among non-Hispanic black pregnancy-related deaths, the following 
were the five leading underlying causes:
  1. Cardiomyopathy (at 14.0 percent),
  2. Cardiovascular and coronary conditions (at 12.8 percent),
  3. Preeclampsia and eclampsia (at 11.6 percent),
  4. Hemorrhage (at 10.5 percent), and
  5. Embolism (at 9.3 percent).
    These causes represent just 58.1 percent of non-Hispanic black 
pregnancy-related deaths, suggesting a broader diversity of pregnancy-
related causes of death among non-Hispanic black women than among non-
Hispanic white women.
    CDC is providing assistance to states to gather, analyze and use 
data to better understand how pregnancy-related mortality can be 
prevented in their states. Including data addressing both the clinical 
and non-clinical contributors to maternal deaths will allow states to 
fully address racial, geographic, and economic disparities in maternal 
mortality.
                        healthcare marketplaces
    Question. Last October the Trump Administration halted cost-sharing 
reduction (CSR) payments to qualified health plans, creating chaos in 
the individual insurance market at the exact time that most insurers 
were finalizing their premiums. The move resulted in increased premiums 
and reduced issuer participation for the 2018 plan year. This was one 
of many decisions the Administration made to sabotage our healthcare 
system and was in line with President Trump's statement that the best 
political course of action would be to let the marketplaces 
``explode.''
    Ending CSR payments was one of numerous other policies that 
contributed to an unstable market and rising premiums, including 
expanding the use of ``junk,'' short-term plans, slashing advertising 
and in-person assistance, and weakening the essential health benefits. 
That said, state regulators are stepping in to mitigate the damage.
    Most states across the country adopted a strategy called ``silver 
loading'' in which they allowed or required insurers to load the entire 
cost of CSR non-payment onto silver-level coverage. ``Silver-loading'' 
had the unintended effect of increasing the value of advance premium 
tax credits that enrollees receive while mitigating premium increases 
on bronze- and gold-level coverage. As a result, the Kaiser Family 
Foundation estimated that a 40-year-old with an annual income of 
$25,000 had access to at least one free bronze plan in 1,679 counties. 
That same study found that the lowest-cost gold plan was cheaper than 
the lowest-cost silver plan in 478 counties.
    Officials from the Department of Health and Human Services are 
consistently declining to Response questions regarding whether the 
Department will permit silver-loading for the 2019 plan year.
    Will HHS let states permit or require insurers to load the cost of 
CSR non-payment onto silver-tier plans for the 2019 plan year?
    Answer. CMS continues to look at a number of factors in the health 
insurance market impacting patient cost.
    Question. When will you advise issuers of this decision?
    Answer. CMS continues to look at a number of factors in the health 
insurance market impacting patient cost.
                               lymphedema
    Question. Many of my colleagues and I have been committed to 
helping patients suffering from chronic lymphatic system failure 
(lymphedema). This is not just one disease but a condition that can 
occur primary or secondary when the lymph vessels and/or nodes are 
compromised--a condition that does not have a cure. We hear about it 
now far more frequently due to increased cancer survivorship, but it 
can present in almost 40 different rare diseases or be acquired from 
over a dozen other traumatic causes. Given the expansive medical 
literature, which cites effectiveness of compression garment therapy 
and the cost savings associated with reductions in complications, 
hospitalizations, and physician and therapy visits, up to 3 million 
Medicare beneficiaries stand to benefit by better managing this chronic 
condition. The need for this was acknowledged and outlined originally 
by the Center for Medicare and Medicaid Services 2001 Decision Memo 
(CAG-00016N).
    Will HHS prioritize a rule providing coverage for these items and 
supplies this year?
    Answer. Medicare's coverage criteria and benefit categories has 
remained largely unchanged since the program was first established more 
than 50 years ago. It is important to make sure that we are not being 
short sighted and failing to cover a treatment or item that will 
improve health and save money simply because it does not fit into a 
benefit category in Medicare. I would be happy to work with you and 
with CMS to explore whether separate coverage of and payment for 
compression garments is possible under the Medicare Part B benefit 
categories established in the statute.
    Question. We are facing a child care crisis in this country, with 
parents struggling to find and pay for high-quality, early childhood 
education. I was proud to fight for a commitment in the fiscal year 
2018 Bipartisan Budget Act to double funding for child care for fiscal 
year 2018 and fiscal year 2019, and I look forward to working with my 
colleagues to ensure that we are able to sustain and build on these 
increases long term. The fiscal year 2018 Omnibus joint explanatory 
statement outlines the Committee's expectations that the Department 
should support states as they work to effectively use the $2.37 billion 
increase to the Child Care and Development Block Grant provided in 
fiscal year 2018. What are the Department's plans for meeting that 
expectation, especially when it comes to helping states accomplish the 
goals outlined in the explanatory statement and sustain those goals in 
the long-term?
    Answer. The additional $2.37 billion doubled the discretionary 
funding for the Child Care and Development Fund (CCDF), leading to an 
overall increase in CCDF funding of about 41 percent. With this 
increase, the Department will make about $8.1 billion available to 
states, territories, and tribes. Under the CCDF final rule published in 
September 2016, states must meet all statutory and regulatory 
requirements by October 1, 2018, with the exception of background check 
requirements, for which states may receive time-limited extensions. 
States and territories will be submitting their CCDF Plans for fiscal 
year 2019-fiscal year 2021 this summer. These plans will provide HHS 
with updated information about the status of implementation across the 
country.
    To help CCDF grantees accomplish the goals outlined in the 
explanatory statement and sustain those goals in the long-term, the 
Department will be issuing guidance outlining current requirements and 
priorities that align with the Joint Explanatory Statement, providing 
training and technical assistance through the early childhood and 
school-age training and technical assistance system in collaboration 
with the Office of Child Care and, sharing relevant research to inform 
state and local policymakers as they continue to implement CCDBG 
reauthorization and the increased funding through research reports and 
briefs posted online and sent to grantees and through webinars and 
presentations at conferences such as the CCDF State and Territory 
Administrators Meeting (STAM) . The Department will also use increased 
oversight to ensure compliance with CCDBG Act requirements. Oversight 
will be done through the review and approval of the fiscal year 2019-
2021 CCDF State and Territory Plans and the fiscal year 2020-2022 CCDF 
Tribal Plans and through onsite monitoring.
    Question. How does the Department plan on engaging with 
stakeholders as they spend the increased funds to ensure technical 
guidance and assistance is meeting their needs?
    Answer. The Office of Child Care (OCC) Regional Staff are the first 
point of contact for engaging with states, territories, and tribes as 
they plan for, and spend, the increased funds. They work closely with 
CCDF grantees to provide guidance, answer questions, track progress on 
implementation of reauthorization through the state plan amendment 
process, and direct issues to the Office of Child Care Central Office. 
The different centers in the early childhood and school-age training 
and technical assistance system engage with CCDF Lead Agencies through 
the OCC Regional Staff to assess their training and technical 
assistance needs and provide resources and supports that are responsive 
to individual grantee requests. Additional information about the 
technical assistance available to CCDF Lead Agencies is available at 
https://childcareta.acf.hhs.gov/about-acf-tta-system. OCC is hosting 
calls with CCDF Lead Agencies to provide updates and respond to 
questions from administrators. In person meetings with administrators 
will also provide the opportunity to discuss CCDF Lead Agency progress 
and challenges. These meetings include regional meetings, the national 
State and Territory Administrators Meeting (STAM) in August, and three 
Tribal conferences across the country this fall.
    Question. On April 10th, President Trump issued an executive order 
entitled ``Reducing Poverty in America by Promoting Opportunity and 
Economic Mobility.'' The executive order outlined ``Principles of 
Economic Mobility'', which included improving employment outcomes by 
strengthening work requirements. The executive order directed the 
Department of Health and Human Services to review all regulations, 
guidance documents, and work requirements in its public assistance 
programs to determine if they align with those principles of economic 
mobility. Most research, including reports done by the Center on Budget 
and Policy Priorities and the Urban Institute, shows that work 
requirements have not proven to be effective in helping families secure 
stable, well-paying jobs that get them off assistance for good. What 
data and evidence is HHS using to evaluate its regulations, guidance 
documents and public assistance programs as it pertains to the 
effectiveness of work requirements?
    Answer. The President's Executive Order states that ``bipartisan 
welfare reform enacted in 1996 was a step toward eliminating the 
economic stagnation and social harm that can result from long-term 
Government dependence.'' This success can be seen in the data. After 
welfare reform, the employment rate of single mothers rose from an 
average of 58.6 percent in the 5 years preceding welfare reform (1991-
1995) to an average of 70.2 percent in the 5 years after reform (1997-
2001).\1\ As a result, the official poverty rate among single mother-
led families fell from 44.0 percent in 1994 to 33.0 percent in 2000 and 
was still well below pre-welfare reform levels in 2016 (35.6 
percent).\2\ While the strength of the TANF program in promoting 
employment has faded over time, as part of this review, we intend to 
reinvigorate the focus on employment and personal responsibility 
throughout HHS programs in order to generate further increases in 
employment and reductions in poverty for all Americans.
---------------------------------------------------------------------------
    \1\ ASPE tabulations from the Current Population Survey, Annual 
Social and Economic Supplement.
    \2\ US Census Bureau, Historical Poverty Tables, Table 4, https://
www.census.gov/data/tables/time-series/demo/income-poverty/historical-
poverty-people.html.
---------------------------------------------------------------------------
    Question. What metrics will HHS be using as it evaluates programs 
in order to comply with the directives outlined in the executive order?
    Answer. While review of our programs, regulations, and guidance 
documents continues as directed by EO 13828, HHS intends to pursue 
policies that will help grow the capacity of low-income individuals to 
reduce their need for and dependency on safety net benefits--this is 
how we will evaluate the success of programs and policies. Our goal 
will never be solely to reduce caseloads in assistance programs, but to 
help recipients move beyond their need for that assistance.
    Question. The fiscal year 2018 Omnibus joint explanatory statement 
directs the Department to provide the necessary technical assistance, 
monitoring and oversight to assist and evaluate states' activities to 
improve infant plans of safe care for prenatally-exposed infants, as 
defined in the Child Abuse Prevention and Treatment Act. What are the 
Department's plans for fulfilling that directive?
    Answer. ACF has reserved a at least $25,000 of the $60 million 
increase in CAPTA State Grants to support monitoring of states' 
implementation of Plan of Safe Care (POSC). Due to the shortened 
timeframe for carrying out and developing a monitoring protocol in 
fiscal year 2018, the Children's Bureau plans to carry out a limited 
number of site visits to several states across the regions during the 
remainder of fiscal year 2018. The purpose of the CAPTA POSC Site Visit 
is to gain a greater understanding of the state's policies and 
practices related to the Comprehensive Addiction and Recovery Act of 
2016 (CARA) amendments to CAPTA POSC. The site visit will assist us in 
identifying promising practices, as well as the challenges and barriers 
to the implementation of POSC, and provides an opportunity to discuss 
potential technical assistance needs. Following the site visit, the 
Children's Bureau will provide summary information on the site visit, 
including identifying strengths of the state's implementation of POSC, 
existing challenges and barriers, as well as resources and technical 
assistance opportunities.
    Question. What technical assistance and guidance does the 
Department plan on providing to states regarding plans of safe care?
    Answer. The National Center on Substance Abuse and Child Welfare 
(NCSACW), which is an HHS initiative jointly funded by SAMHSA and ACF 
continues to provide technical assistance to states in a variety of 
ways to support their efforts in protecting infants born substance-
exposed and support the implementation of the CARA amendments to CAPTA. 
These efforts include:
  --Substance Exposed Infant In-Depth Technical Assistance (SEI IDTA): 
        The SEI IDTA is designed to advance the capacity of tribes, 
        states, and community agencies to improve the safety, health, 
        permanency, and well-being of substance-exposed infants (SEIs) 
        and the recovery of pregnant and parenting women and their 
        families. The program works with states and local communities 
        to strengthen collaboration among child welfare, substance use 
        disorder treatment, and the courts, as well as medical 
        communities, early care and education systems, home visiting, 
        and other key partners, including the implementation of plans 
        of safe care.
  --Regional Convenings--The NCSACW has worked to plan and facilitate a 
        regional convening of states working to implement comprehensive 
        and collaborative approaches to Plans of Safe Care for infants 
        with prenatal substance exposure and their families/caregivers.
    The NCSACW responds to a large number of technical assistance 
requests related to opioid-related issues, including medication-
assisted treatment, neonatal abstinence syndrome, prenatal substance 
exposure and plans of safe care. Requests for technical assistance are 
tailored to the specific needs of the state, as well as addressing the 
needs of multiple states when appropriate. Technical assistance may 
include: responding to requests for information; disseminating written 
materials and resources, and conducting webinars/conference calls.
    In addition, in September 2017, the Children's Bureau funded the 
National Quality Improvement Center for Collaborative Community Court 
Teams (QIC-CCCT) to support demonstration sites that establish or 
enhance collaborative community court teams to design, implement, and 
test approaches to address the rise of substance use disorder 
nationally and the increase in the number of infants and young children 
entering foster care and caregivers. In an effort to support data-
driven, multi-system collaborative team approaches across the country, 
the QIC-CCCT will support demonstration sites to improve or develop 
their capacities to collaboratively serve families; design, implement, 
and test approaches to support the needs of substance exposed infants, 
including addressing the provisions of CARA; and generate knowledge for 
the field. In April 2018, 15 sites in 9 States (Oklahoma, California, 
Alabama, Ohio, Georgia, Florida, Arizona, Alaska, and Texas) and tribal 
communities were selected to participate in the work of the QIC.
    Question. How will the Department continue to monitor States' 
progress in meeting the needs of this population and their families?
    Answer. To the extent funds are available for this purpose, we will 
continue to carry out the process described above. However, regardless 
of funding, we will continue to address CAPTA compliance.
    Responding to changes made by the CAPTA Reauthorization Act of 
2010, ACF issued guidance requiring all states to submit new CAPTA 
state plans, including state plan assurances signed by the governor. 
Once states provide the assurances, the state is in compliance with 
CAPTA.
    If ACF learns there may be a discrepancy between what a state 
submitted in its CAPTA state plan and the actual practices within the 
state, ACF will explore whether a problem actually exists. If the state 
fails to correct the deficiency within a specified timeframe, the state 
risks losing its CAPTA grant funds.
    Question. The fiscal year 2018 Omnibus provided an additional $260 
million for grantees to increase their program hours, in alignment with 
the requirement in the Head Start Program Performance Standards (HSPPS) 
that all programs offer extended duration services by 2021. What 
percentage of programs currently meet the HSPPS duration requirements 
with 100 percent, 50 to 100 percent, 1 to 50 percent, and zero percent, 
respectively?
    Answer:
            Head Start (HS) Center-Based (CB)
    Approximately 37 percent of HS CB programs operate 100 percent 
slots at 1,020 hours.
    Approximately 11 percent of HS CB programs operate between 50 
percent and 100 percent slots at 1,020 hours.
    Approximately 34 percent of HS CB programs operate between 1 
percent and 50 percent slots at 1,020 hours.
    Approximately 18 percent of HS center based programs operate no 
slots at 1,020 hours.
            Head Start (HS) Family Child Care (FCC)
    Approximately 88 percent of HS FCC programs operate 100 percent 
slots at 1,380 hours.
    Approximately 3 percent of HS FCC programs operate between 50 
percent and 100 percent slots at 1,380 hours.
    Approximately 9 percent of HS FCC programs operate no slots at 
1,380 hours.
            Early Head Start (EHS) Center-Based (CB)
    Approximately 80 percent of EHS CB programs operate 100 percent 
slots at 1,380 hours.
    Approximately 3 percent of EHS CB programs operate between 50 
percent and 100 percent slots at 1,380 hours.
    Approximately 2 percent of EHS CB programs operate between 1 
percent and 50 percent slots at 1,380 hours.
    Approximately 15 percent of EHS CB programs operate no slots at 
1,380 hours.
            Early Head Start (EHS) Family Child Care (FCC)
    Approximately 99 percent of EHS FCC programs operate 100 percent 
slots at 1,380 hours.
    Approximately 1 percent of EHS FCC programs operate no slots at 
1,380 hours.

    Question. What is the estimated cost of meeting 100 percent Head 
Start center-based duration requirement by 2021?
    Answer. We estimate the cost of meeting the Head Start 100 percent 
center-based duration requirement by 2021 will be an additional $800 
million beyond the funding that has already been appropriated. This 
estimate assumes fiscal year 2019 funding, but costs can be expected to 
increase over time due to rising costs of living each year.
    Question. Research shows that continuous access to full-day, full-
year early childhood services improves the likelihood of successful 
outcomes for young children from low-income backgrounds. However, HHS 
recently waived the requirement that 50 percent of Head Start center-
based programs extend their services to the equivalent of full-day, 
full-year by August 2019. The notice of the waiver stated that this 
action was necessary due to insufficient funding. Given this, what is 
the rationale for the fiscal year 2019 President's Budget proposing a 
Head Start funding level that is $589 million below the fiscal year 
2018 enacted level (and only $22 million above the fiscal year 2017 
enacted level)?
    Answer. At the time, HHS made the determination to waive the 
requirement for 50 percent of Head Start center-based programs to 
extend their hours of program operation, only $294 million had been 
appropriated to support this service duration increase, which was 
significantly less than the estimated cost for all programs to meet the 
50 percent requirement. Rather than causing a large reduction in 
children served in Head Start programs as the result of a Federal 
requirement, HHS waived the requirement in order to allow programs 
flexibility to design program schedules that best meet their community 
needs. Head Start programs can still offer full-day, full-year services 
if that schedule meets their community needs and is approved through 
their grant application. The fiscal year 2019 request makes decisions 
about funding levels within responsible fiscal constraints; additional 
investments targeted to duration increases are not proposed.
    Question. What is the rationale for the budget request's proposal 
to merge funds for the Early Head Start-Child Care Partnerships into 
the Head Start base grants?
    Answer. The current appropriations language requires grantees to 
track and allocate regular Head Start and Early Head Start funding 
separately from Early Head Start Expansion and Early Head Start--Child 
Care (EHS-CC) Partnership funding across up to six accounts. This 
separate tracking and allocation is administratively burdensome and 
does not result in any benefit to grantees or the government. Merging 
the funding would allow these programs to continue to operate in the 
same way while eliminating unnecessary administrative work for grantees 
and the government.
    Given the increases Congress provided in fiscal year 2018 above the 
requested level for this program, some technical changes to the 
appropriations language are necessary to ensure the Department is able 
to meet the intended goals of the unrequested increases and retaining 
the extended period of availability for the new third round of grants.
    Question. Other than simplifying reporting requirements for 
grantees, will the requested bill language have effect on Early Head 
Start-Child Partnerships, Early Head Start expansion, or Early Head 
Start conversion?
    Answer. While a very small number of 3-year-olds served in EHS-CC 
Partnership family child care programs would need to be transitioned to 
Head Start or other settings if the funding were to be merged in 
appropriations language, the existing EHS-CC Partnerships, EHS 
conversion, and EHS expansion grants would all be able to continue in 
exactly the same way they are currently operating because these models 
and activities are all allowed under the Head Start Act and the Head 
Start Program Performance Standards.
    The current appropriations language states that funds appropriated 
specifically for EHS-CC Partnerships, EHS Expansion, and EHS conversion 
funds ``are available to serve children under age 4'' whereas funds 
used to operate Early Head Start under the base appropriation may serve 
``families with children under age 3'' (Section 645A(c)(2) of the Head 
Start Act). Currently, the flexibility to serve children up to age 4 
has been exercised only by a small number of family child care programs 
in EHS-CC Partnership grants, not by center-based EHS-CC Partnerships 
or EHS expansion programs. Based on 2017 Program Information Report 
(PIR) data, only 4 percent of children in EHS-CC Partnership and EHS 
Expansion programs are at least age 3 at enrollment. If the EHS-CC 
Partnerships funding were to be included in the base appropriation, any 
of those children who had not already aged out of the program once the 
consolidation occurs would need to transition into Head Start slots, 
which could be Head Start slots in centers or in family child care 
settings. Because EHS-CC Partnership grants receive their annual awards 
late in the fiscal year, grantees would operate most of the fiscal year 
2019 program year on their prior year funding, which would give them 
additional time to transition 3-year-old children into other settings 
before receiving fiscal year 2019 funding. OHS would work with grantees 
to ensure smooth transitions for these children in the event that 
language is included to merge funding for Early Head Start-Child Care 
Partnerships into the Head Start base appropriation.
    Question. Head Start programs are playing a unique and important 
role in addressing the effects of substance use disorders, including as 
a result of the opioid epidemic, on low-income young children and their 
parents. Infants born with prenatal exposure are at higher risk for 
short term and long-term effects, including related to growth, 
behavior, cognition, language, and achievement. (http://
pediatrics.aappublications.org/content/pediatrics/131/3/e1009.full.pdf) 
Head Start programs need more resources, including teacher and mental 
health consultants, to continue to respond to these effects, as well as 
the trauma young children are experiencing as a result of the epidemic. 
How is HHS leveraging Head Start and its existing local relationships 
to address the issue of prenatal drug exposure, including neonatal 
abstinence syndrome, as well as increased trauma?
    Answer. All Head Start programs are required to collaborate with 
numerous community partners to facilitate access to responsive services 
for their families to help meet family needs and goals. These partners 
include Healthcare providers, including child and adult mental health 
professionals, Medicaid managed care networks, dentists, other health 
professionals, nutritional service providers, providers of prenatal and 
postnatal support, and substance abuse treatment providers.
    Additionally, the ACF Office of Head Start (OHS) partners with the 
American Academy of Pediatrics to manage its National Center on Early 
Childhood Health and Wellness (NCECHW) and provide education, training 
and resources to its grantees. Grantees and their Health Services 
Advisory Committees partner with agencies in the community to provide 
resources to children and families at risk of impacts from substance 
misuse, including trauma. To date, the NCECHW has developed a substance 
misuse landing page where programs can obtain information and resources 
related to what staff should know, how programs can help, basics on 
opioids and substance misuse, reducing risks for neonatal exposure, 
caring for children exposed to substances, and preparing for sensitive 
conversations. For many years, Early Head Start programs have educated 
pregnant women on the dangers of substance misuse and all Head Start 
programs provide families with resources to educate them about the 
dangers of substance misuse and its impact. Family service workers and 
mental health consultants assist programs in responding to the needs of 
families and in leveraging resources including health and mental health 
resources in the community to provide additional support to families.
    In addition, OHS has a Memorandum of Understanding (MOU) to 
coordinate resources and align policies at the national level with the 
Health Resources and Services Administration, Bureau of Primary Health 
Care (HRSA/BPHC), as well as to foster a partnership at state and local 
levels, that will lead to an increase in access to quality, culturally 
and linguistically appropriate comprehensive primary healthcare 
services in states where programs exist. Under this agreement, HRSA and 
OHS will work collaboratively to support the development and 
strengthening of linkages between their programs at the local or state 
level and establishment of measures for evaluation of improved health, 
dental, and behavioral health outcomes and health center access and 
utilization.
    Question. How is the Department supporting the 1,600 Head Start 
grantees to address the increased workload and challenges as a result 
of the opioid epidemic?
    Answer. The Office of Head Start (OHS) is providing information and 
training and technical assistance related to substance misuse and 
specifically the opioid crisis. Through its website, Early Childhood 
Learning and Knowledge Center (ECLKC) resources are being disseminated 
to all grantees (https://eclkc.ohs.acf.hhs.gov/mental-health/article/
substance-misuse.) These materials include educational materials about 
opioids and substance misuse and impact on children and families.
    Head Start, home visitors, and child care staff often have a window 
into the real-life circumstances and needs of families. These programs 
may be the front-line in identifying issues that signal substance 
misuse. It can be hard to navigate these complex situations, but Head 
Start programs have unique opportunities to engage families and even 
prevent harm to children. Head Start programs can be a valuable 
resource to families by helping them to know what services are 
available in the community. A Head Start program's Health Services 
Advisory Committee (HSAC) can develop policies, guidelines, and 
community partnerships by knowing the eligibility requirements of 
programs that serve families impacted by opioid misuse. This 
information is necessary when discussing service and treatment options 
with families.
    In addition, this summer, OHS is holding an Expert Work Group on 
Substance Use Disorder with a focus on the opioid epidemic and its 
impact on young children and their families. The work group will be 
comprised of experts on substance use disorders, with a focus on the 
opioid crisis and its impact on young children and how to support local 
Head Start programs in responding to the opioid epidemic. Experts are 
expected to share their current research and knowledge with a focus on 
the types of strategies that would be most helpful to those serving 
children and families.
  --We anticipate the following outputs from this Work Group: 
        Summarized notes, proceedings, and key messages from the expert 
        work group will be shared;
  --Standardized PowerPoint presentations developed as an outgrowth of 
        the meeting that can be shared with grantees;
  --Increased knowledge of current and future work by each national 
        Training/Technical Assistance (T/TA) center that can be used or 
        modified across all T/TA centers to help to support grantees;
  --Repository of core documents that can be modified and supplemented 
        with information germane to a variety of recipients;
  --Stronger consensus in the field regarding the most effective 
        strategies for supporting young children, families, programs 
        and communities impacted by opioid use disorders; and
  --Increased knowledge of successful community-level pilots and 
        projects that may help other communities develop similar 
        programs and strategies.
    Question. Head Start programs have been tackling the issues 
resulting from the opioid epidemic for years, providing behavioral, 
mental health, and community supports to children affected by this 
crisis, as well as other drug crises. As HHS makes decisions about how 
to implement increased funds and address the opioid epidemic, how will 
HHS engage the Office of Head Start to share best practices with Head 
Start agencies and other early childhood education programs across the 
country?
    Answer. OHS has a long history of providing support and assistance 
to families impacted by substance misuse and other trauma. OHS utilizes 
existing systems and partners in order to bolster its response to the 
current crisis. For example, OHS is partnering with colleagues in HHS 
that include other ACF agencies such as the Children's Bureau, and 
other operating divisions such as SAMSHA, CDC, and NIH, and sharing 
information and resources that can be disseminated to Head Start 
grantees, child care providers, and early childhood programs across the 
country. OHS's website (ECLKC) is a resource for all early childhood 
programs; training materials and resources are available to everyone at 
no cost.
    In addition OHS, is a co-lead with HRSA and SAMHSA on the 
Interagency Workgroup on the Impact of Opioids on Young Children and 
Families, which includes a wide variety of participants across 
agencies. The purpose of the group is:
  --To share information and materials related to the impacts of opioid 
        misuse on pregnant women, infants, and their families, to 
        ensure that we all have access to the most up-to-date resources 
        and information;
  --To share resources and guidance that each agency or program is 
        developing for its grantees (or other audiences), to ensure 
        clarity and consistency across programs and agencies, to the 
        extent possible, and to reduce duplication;
  --To share what each agency/program is learning from its grantees and 
        the field (both in terms of challenges and strategies for 
        addressing the issue) that can be captured and shared more 
        widely in order to promote best practice and innovation; and
  --To share what each agencies is doing to address the issue so that 
        all involved agencies are more aware of the range of Federal 
        resources and activities being devoted to this crisis.
    Information from the workgroup helps to drive information that OHS 
can make available to grantees via the ECLKC substance misuse landing 
page.
    Question. Does the Department believe that HHS should fund adoption 
agencies that refuse to house children in loving homes because the 
adoption agency objects to children being raised by same-sex couples?
    Answer. Title IV-E of the Social Security Act provides Title IV-E 
agencies with significant latitude to determine how and under what 
conditions an agency will license or approve prospective foster or 
adoptive parents. The Act requires each state or tribe operating a 
Title IV-E program to designate or establish a licensing authority that 
establishes and maintains standards for foster homes and child care 
institutions that are reasonably in accord with nationally recommended 
standards. The Act does not apply the foster family home licensing 
standards to adoptive family homes, rather, an agency must place a 
child for adoption in accordance with applicable state, tribal, and 
local law.
    HHS does not impede the placement of children in eligible same-sex 
households and also does not impede the full participation of religious 
organizations in foster care and adoption. As a general matter, HHS 
supports the prompt placement of children in loving homes according to 
the best interests of the child and supports giving states flexibility 
in meeting that standard consistent with Federal law.
    Question. If HHS's position is that such type of discrimination 
should not be funded by taxpayer dollars, what course would the agency 
take if the adoption refuses to place children in same-sex households 
due to their religious beliefs?
    Answer. As a general matter, HHS supports the prompt placement of 
children in loving homes according to the best interests of the child 
and supports giving states flexibility in meeting that standard 
consistent with Federal law.
    Everyone deserves to be treated with respect and given every 
protection afforded by the Constitution and laws passed by Congress. We 
will examine any particular situation that arises on these issues with 
sensitivity and will apply the law to the facts of each particular case 
fairly, impartially, and appropriately. This means we cannot prejudge 
cases or hypothetical scenarios but must wait until a concrete 
complaint is brought before us.
    Question. Valid and reliable data on children involved in our child 
welfare system is critical for understanding and improving our nation's 
support for our most vulnerable children and families. Unfortunately, 
the Adoption and Foster Care Analysis Reporting Systems (AFCARS) data 
points have not been updated since they were first finalized in 1993. 
In December 2016, HHS finalized a critical rule to update these data 
points to align with congressional mandated provisions of laws such as 
the Fostering Connections to Success and Increasing Adoptions Act of 
2008 and the Preventing Sex Trafficking and Strengthening Families Act 
of 2014. I was particularly glad to see new information collected on 
educational stability for children and youth in foster care, which is 
critical for implementing the Every Student Succeeds Act with fidelity. 
On March 15th, HHS proposed to amend and delay these important updates 
for 2 years with reporting not expected until October of 2021. Please 
explain why HHS believes it is acceptable to delay the collection of 
congressionally-mandated data elements until 2021, especially in light 
of the fact that states have been planning for these upgrades since 
2016.'
    Answer. In response to EO 13777, the Department of Health and Human 
Services' (HHS) Regulatory Reform Task Force identified the AFCARS 
regulation as one where there may be areas for reducing reporting 
burden and where costs may exceed benefits. HHS published on March 15, 
2018 an Advance Notice of Proposed Rulemaking (ANPRM) seeking public 
suggestions for streamlining the AFCARS data elements and removing any 
undue burden related to reporting AFCARS, per the directive of the E.O. 
The delay allows HHS time to consider the comments to the ANPRM and, if 
necessary, use them to draft a NPRM proposing revisions to the AFCARS 
that are in line with the directive of the E.O. It will also allow 
title IV-E agencies ample time to consider the full impact the data 
reporting from the December 2016 AFCARS final rule and provide HHS with 
specific comments on the burden associated with the December 2016 final 
rule.
    Section 479 of the Social Security Act requires us to regulate the 
AFCARS requirements. There is no legislative deadline established in 
the Act for updating or issuing regulations. Thus, it is within our 
authority to issue regulations and revise the regulations as directed 
in the E.O. Title IV-E agencies will continue to submit AFCARS data per 
the requirements in regulations 45 CFR 1355.40 and the appendix to part 
1355 as they have been.
    Question. In February, Congress passed and the President signed 
into law the most significant reforms to our Nation's child welfare 
system in decades. The Family First Prevention Services Act (FFPSA) 
reorients our child welfare system toward prevention by allowing states 
to draw down Federal funds for evidence-based prevention services in 
two areas: (1) in-home parent skills-based programs; and (2) substance 
abuse and mental health treatment services, for children at ``imminent 
risk'' of entering foster care. Understanding the scope of programs 
that will meet the ``evidence-based'' standard and disseminating this 
information to states and child welfare agencies will take significant 
collaboration between the various agencies with jurisdiction over 
prevention services, including but not limited to the Administration 
for Children and Families, Substance Abuse and Mental Health Services 
Administration, and the Health Resources and Services Administration. 
How will you promote collaboration between the relevant agencies tasked 
with ensuring effective implementation of FFPSA, particularly before 
the October 1st deadline for HHS to release guidance on the practice 
criteria required for the prevention services as well as a pre-approved 
list of services and programs that meet the law's evidence standards?
    Answer. Over the next few months, the Administration for Children 
and Families intends to consult broadly across HHS and the field in the 
development of the criteria by which interventions will be assessed in 
determining which interventions are approved for funding under the 
title IV-E prevention services program. HHS has held an External 
Stakeholder meeting, including the National Governor's Association, 
National Association of Counties, and National Conference of State 
Legislators, and has met with county child welfare directors in 
Colorado and Minnesota. The Children's Bureau has also issued a Federal 
Register Notice seeking comment on proposed criteria for identifying 
evidence-based practices for implementation of FFPSA. Further meetings 
and listening sessions are planned for the coming months.
    Question. As Director of the Office of Refugee Resettlement, Scott 
Lloyd had denied young women, even those who are pregnant as a result 
of rape, of their constitutional right to access abortion. ORR has 
reportedly posted instructions for young women to seek counseling from 
crisis pregnancy centers that discourage abortions, and to provide 
brochures with misleading information including inaccuracies on the 
medical risks of abortion. At the House Appropriations hearing this 
past March, Secretary Azar stated that he will ``absolutely comply with 
the law and constitution as determined by the courts.'' A Federal judge 
has ordered the Department to stop blocking children in its care from 
obtaining abortions, and to post a notice in shelters to inform them of 
their right to decide whether to have an abortion. What is the 
Department doing to ensure that ORR complies with the court's order to 
stop blocking access to abortion care?
    Answer. ORR has already sent notice to all of its shelters 
informing them of the requirement to post the notice ordered by the 
district court, has followed up on its instruction, and has informed 
the minority of shelters with conscientious objections that corrective 
action is necessary. The Department expects full compliance with the 
district court's order. In addition, the Department has appealed the 
district court's order to the Court of Appeals for the D.C. Circuit, 
but will continue to comply with the district court's order as long as 
it stands.
    Question. How are you enforcing the requirement that all ORR-funded 
shelters post a notice informing minors of their rights?
    Answer. ORR monitors all care providers for compliance with ORR 
policies and, when applicable, court orders. Monitors have been 
informed of notice requirements and will ensure compliance with the 
court order from U.S. District Court Judge Tanya Chutkan. Programs 
subject to the court order have also been notified of the order. If ORR 
receives information that a program is not in compliance with the court 
order, ORR will investigate and act accordingly. Project Officers have 
been instructed to contact each of the facilities they oversee to ask 
about the facility's compliance with the court order. Federal Field 
Specialists that routinely visit facilities have also been instructed 
to ensure compliance with the court order. Facilities not in compliance 
are subject to corrective actions.
    Question. As the Office of Refugee Resettlement consolidates 
funding for refugee support services, how is it implementing the 
expectation in the fiscal year 2018 Omnibus that activities funded in 
the Social Services, Targeted Assistance, and Prevention Health be 
continued at the same funding levels as in fiscal year 2017?
    Answer. Under the proposal presented in the fiscal year 2018 Budget 
and adopted in the fiscal year 2018 Omnibus, ORR will ensure funding 
levels for Social Services, Targeted Assistance, and Refugee Health 
Promotion (formerly Prevention Health) will be funded as close as 
possible to fiscal year 2017 levels within the current budget.
    Question. In a United Nations panel on April 10th, Office of 
Refugee Resettlement Director Scott Lloyd said the Administration is 
trying to ``improve the legal framework whereby this [Unaccompanied 
Children] program can be more focused on those who have legitimate 
claims for asylum or Special Immigrant Juvenile Status.'' What options 
is ORR considering to achieve this stated goal of improving processing 
of unaccompanied children through the immigration system, including 
changes through Federal rulemaking as well as internal policies and 
procedures?
    Answer. ORR is currently working with DOJ and DHS to determine how 
the three agencies can improve the processing of UACs in the 
immigration system.
    Question. How do those changes align with the Trafficking Victims 
Protection Act, the Homeland Security Act, and the Flores settlement?
    Answer. Any changes will align with the William Wilberforce 
Trafficking Victims Protection Reauthorization Act of 2008, the 
Homeland Security Act of 2002, and the Flores settlement agreement.
                                 ______
                                 
            Questions Submitted by Senator Richard J. Durbin
                              child trauma
    Question. Experiencing traumatic events--such as witnessing 
violence or a parent's opioid addiction--can create toxic stress on a 
young child's developing brain and body. Exposure to these sorts of 
traumas (also known as adverse childhood experiences) at a young age 
increases the likelihood that children enter the foster care system, 
misuse substances, face mental health challenges, or develop chronic 
diseases--all health consequences that the Department seeks to address 
through various grant programs. Effective interventions and tools exist 
to mitigate the impact of trauma and to prevent long-term negative 
health outcomes, such as by strengthening protective factors, building 
nurturing environments, encouraging trauma-informed practices, and 
building strong two-generational interventions. It is imperative that 
these child-serving systems that may come into contact with children 
and families that have experienced trauma have the training and 
resources to identify and support such children with appropriate 
interventions and referral systems.
    Along with Senator Capito and leadership of this Subcommittee, I 
included report language in the fiscal year 2018 Senate Labor-HHS-ED 
appropriations bill, which was effectuated with enactment of the 
Omnibus appropriations bill addressing activities under the Department 
related to children exposed to trauma (bill-wide directive found on 
page 14 of Senate Report 115-150). The report language encourages the 
Department to ``examine practices already supported by Federal agencies 
and solicit public feedback in order to identify, recommend, and 
disseminate best practices for the identification, referral, and 
implementation of trauma-informed interventions in child and youth-
serving settings'' and ``promote programs that incorporate trauma-
informed best practices.'' Indeed, helping children and families cope 
with traumatic experiences can help uplift our communities and improve 
health outcomes, and is a cost-effective way to fulfill the mission of 
the Department.
    How is your Department implementing this report language to better 
support children who have faced traumatic experiences?
    Answer. The Department continues to enhance coordination, identify 
trauma-informed best practices, and promote programs to identify, 
appropriately refer, and implement supportive interventions for, 
children and their families who have experienced trauma.
    The HHS Strategic Plan, fiscal year 2018-2022 addresses trauma as 
part of our strategic goal to strengthen the economic and social well-
being of Americans across the lifespan. The Strategic Plan recognizes 
how trauma has lasting adverse effects on the individual's functioning 
and mental, physical, social, emotional, or spiritual well-being. HHS 
supports multiple trauma-informed care initiatives \3\ to integrate a 
trauma-informed approach into health, behavioral health, and related 
systems, to reduce the harmful effects of trauma and violence on 
individuals, families, and communities. HHS also works across the 
Federal Government, and with States, territories, Tribes, and faith-
based and community organizations, to address trauma associated with 
injuries and violence.
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    \3\ https://www.cdc.gov/injury/stateprograms/index.html.
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    The Office of the Assistant Secretary for Planning and Evaluation 
(ASPE) has initiated an informal interagency working group on child 
trauma that includes partners within HHS, such as Administration on 
Children and Families, the Health Resources and Services 
Administration, the Centers for Disease Control and Prevention, and the 
Substance Abuse and Mental Health Administration (SAMHSA), along with 
Federal partners in agencies outside HHS, including the Departments of 
Justice, Education, and Labor. ASPE hosts a monthly call of this 
working group for the purpose of coordination of Federal efforts on 
child trauma, and is working to understand both the scope of work 
across agencies and any coordination efforts on the ground in local 
communities receiving Federal funding for trauma-informed interventions 
for children, youth, and their families.
    HHS funds 23 State health departments through the Core State 
Violence and Injury Prevention Program,\4\ which helps States 
implement, evaluate, and disseminate strategies that address the most 
pressing injury and violence issues, including child abuse and neglect, 
traumatic brain injury, domestic violence, and sexual violence. HHS 
also works across the Federal Government, and with States, territories, 
Tribes, and faith-based and community organizations, to address trauma 
associated with injuries and violence.
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    \4\ https://www.cdc.gov/injury/stateprograms/index.html.
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    For example, we will expand bullying prevention and youth dating 
violence prevention partnerships to support safety and well-being. We 
will assess, and increase, the capacity of medical and behavioral 
health practitioners, nonprofits, faith-based and community 
organizations, licensed social workers, child welfare professionals, 
housing authorities, and public health agencies to provide 
comprehensive and survivor-informed services for victims of human 
trafficking. HHS will enhance the cultural competence of the workforce 
in the delivery of social services to children, youth, and families 
through research, technical assistance, and training, including 
information on addressing and mitigating the impact of trauma. We will 
also support the integration of trauma-informed, family-focused 
behavioral health services with pediatric primary care.
    Most recently, the HHS Substance Abuse and Mental Health Services 
Administration and the Administration of Children and Families co-
hosted a human trafficking and child trauma expert panel meeting on May 
2-3, 2018, to inform recommendations on how to strengthen prevention, 
clinical care and coordination, and the availability of resources and 
technical assistance to address both the impact of exploitation and to 
mitigate trauma that puts individuals at greater risk for human 
trafficking.
    HRSA supports several programs for healthcare, clinician training, 
and research to improve access for vulnerable and underserved 
populations, many of whom have experienced or witnessed trauma. HRSA 
supports programs that train pediatric primary care providers to 
recognize exposures to adverse childhood experiences, as well as 
programs that promote trauma informed care in school-based settings. 
The Bright Futures: Guidelines for Health Supervision of Infants, 
Children, and Adolescents provides evidence-driven recommendations for 
healthcare professionals to address during well-child visits, including 
social determinants of health such as poverty, parental mental illness 
or substance use, and parental incarceration. HRSA also leads a Federal 
interagency effort to improve emergency care for children experiencing 
mental health crisis in rural areas, which encourages identification, 
referral, and treatment of trauma. Additionally, HRSA has developed and 
adopted an agency-wide Strategy to Address Intimate Partner Violence, 
committing to making a systems-level impact on intimate partner 
violence and trauma awareness, screening, and treatment across the 
healthcare and public health sectors.
    ASPE is also funding research in the upcoming fiscal year that will 
formally scan Federal agencies to identify supported approaches and 
promote programs that incorporate trauma-informed best practices aimed 
at building resilience in children, youth and their families. 
Previously, as part of the Behavioral Health Coordinating Committee, 
ASPE participated in efforts to compile the HHS Guide to Trauma-
informed Human Services,\5\ an online compendium of Federal and 
federally supported resources that provides an introduction to the 
topic of trauma and a roadmap to information relevant to human services 
agencies.
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    \5\ https://www.acf.hhs.gov/trauma-toolkit.
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    The Children's Health Act of 2000 authorized the Substance Abuse 
and Mental Health Services Administration (SAMHSA) to develop a 
national grant program to focus on child and adolescent trauma, the 
National Child Traumatic Stress Initiative (NCTSI). The purpose of the 
NCTSI is to improve the quality of trauma treatment and services in 
communities for children, adolescents, and their families who 
experience or witness traumatic events, and to increase access to 
effective trauma-focused treatment and services for children and 
adolescents throughout the nation.
    The initiative addresses child trauma issues by creating a national 
network of grantees--the National Child Traumatic Stress Network 
(NCTSN) or Network--that works collaboratively to develop and promote 
effective trauma treatment and services for children, adolescents, and 
their families. The NCTSN is a unique network of frontline providers, 
family members, researchers, and national partners committed to 
changing the course of children's lives by improving their care and 
moving scientific gains quickly into practice across the United States.
    The NCTSN is comprised of three types of centers:
  --The National Center for Child Traumatic Stress (NCCTS)--(Category 
        I) develops and maintains the collaborative network structure, 
        supports resource development and dissemination, and 
        coordinates the Network's national child trauma education and 
        training efforts.
  --The Treatment and Service Adaptation Centers (TSA)--(Category II) 
        are intended to have broad geographic coverage and expertise in 
        a range of trauma areas, service systems, settings, and 
        populations. TSA centers provide training and consultation to 
        support the specialized adaptation and implementation of 
        effective evidence-based treatment and service approaches for 
        communities across the Nation.
  --The Community Treatment and Services Centers--(Category III) 
        provide and increase access to effective trauma-focused 
        treatment and services in community settings and youth-serving 
        systems.
    The NCTSN Learning Center for Child and Adolescent Trauma, https://
nctsn.org, offers over 300 web-based training resources that has 
supported approximately 200,000 users across the country. In addition, 
the Learning Center hosts live training events. The dissemination of 
standardized, effective, trauma-informed clinical interventions is a 
central means by which the NCTSN seeks to advance the standard of care 
for traumatized children and to increase the nation's capacity to meet 
the needs of these children. In recognition of the diverse needs of the 
child and adolescent populations served by NCTSN sites across the 
country, over 30 interventions and treatments developed or adapted by 
the NCTSN have spanned a continuum of evidence-based and evidence-
supported interventions ranging from rigorously evaluated interventions 
to promising and newly-emerging practices.
                     maternal and infant mortality.
    Question. The U.S. is one of only 13 countries in the world where 
new moms are dying at rates higher today than they were 25 years ago. 
Women of color are three to four times more likely to die from 
pregnancy-related complications than white women. Our babies are not 
faring better--in 1960, the U.S. ranked 12th among developed countries 
in infant mortality. Today, we rank 32nd out of 35. Black infants in 
America are twice as likely to die as white infants. We know that 
increasing women's access to healthcare would help--which is why we 
should not allow ``junk plans'' that exclude maternity benefits and why 
the 18 States who have refused to expand Medicaid should do so 
immediately.
    But, what else should HHS be doing to address this problem?
    Answer. HRSA is committed to improving the health of women, infants 
and children including addressing disparities in maternal and infant 
mortality and morbidity. The response to Q2A below includes additional 
descriptions of HRSA's ongoing investments to address maternal and 
infant mortality and morbidity. HRSA programs focus on continuous 
quality improvement and ways to improve our impact, as well as enhance 
the capacity of states and stakeholders to address these public health 
issues. For example, HRSA supports the Alliance for Innovation on 
Maternal Health and Safety Initiative, or AIM, a national data-driven 
maternal safety and quality improvement initiative that implements 
maternal safety bundles--small, straightforward sets of evidence-based 
practices that, when performed collectively and reliably, have been 
proven to improve patient outcomes--within birthing facilities to 
address leading causes of maternal death, such as hemorrhage and 
hypertension. Through AIM, HRSA works directly with women's health 
practitioners in birthing facilities reaching 1,780,000 annual births 
or 45 percent of all annual births in the U.S. In fiscal year 2018, 
HRSA is doubling the investment in AIM to $2 million to support the 
existing state teams and add 25 new state-based teams. Further 
expansion of evidence-based safety bundles in all states would increase 
the chances of improving outcomes such as those we've seen with AIM 
investment to date.
    As another example, HRSA is building on early successes from its 
Collaborative Improvement and Innovation Network (CoIIN) on Infant 
Mortality which seeks to reduce infant mortality in areas with high 
annual rates, as well as disparities in infant mortality and related 
perinatal outcomes, through support of collaborative improvement, 
collaborative innovation, and the spread and scale of best practices to 
reduce infant mortality. The CoIIN launched in 2012 at the request of 
southern state health officials, and was the first multi-state public 
health quality improvement initiative to address infant mortality. A 
recent study led by HRSA researchers evaluated data from 2011-2014, 
comparing outcomes before and after the CoIIN's original 18-24 month 
project period in the Department of Health and Human Services Regions 
IV/VI.\6\ Early elective delivery decreased by 22 percent in the South, 
versus 14 percent in other regions. Alabama and Louisiana showed the 
largest reductions in the nation at more than 40 percent. Results in 
the South also showed that the rates of stopping smoking during 
pregnancy increased by 7 percent, infant back sleep position increased 
by 5 percent, and preterm birth fell by 4 percent; other regions only 
showed improvements of 2 percent for each of the outcomes measured. 
Preliminary data indicating CoIIN's success in the South and in the 
subsequent national expansion to all states (2014-2017) led to current 
HRSA support of four IM CoIIN teams aiming to improve preconception 
health, increase use of early prenatal care, increase safe sleep 
practices, and address social determinants of health. Twenty-one States 
are participating in the current phase of IM CoIIN.
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    \6\ https://www.hhs.gov/about/agencies/iea/regional-offices/
index.html.
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    Question. What HHS programs are most important for improving 
maternal and infant health outcomes and addressing these stark racial 
disparities?
    Answer. HRSA supports several programs and activities to improve 
the health of America's mothers, infants, and children in order to 
ensure that all children and families are healthy and thriving, and 
have a fair shot at reaching their fullest potential. The HRSA-
supported Title V Maternal and Child Health Services Block Grant 
program, a Federal-state partnership, helps reduce health disparities, 
improves access to healthcare, and improve the quality of healthcare 
for mothers and children in 59 States and territories. Title V Federal 
funds, combined with state investments, support service systems that 
address maternal and child health needs identified by each state such 
as reducing infant mortality; assuring access to care for all mothers 
and children; providing comprehensive care for all women before, 
during, and after pregnancy and childbirth; providing preventive and 
primary care services for all infants, children, and adolescents; and 
providing comprehensive care for children and adolescents with special 
healthcare needs.
    HRSA also supports community-based strategies to reduce disparities 
in infant mortality and improve perinatal outcomes for women and 
children in high-risk communities through the Healthy Start program. 
Healthy Start empowers high-risk women and their families to identify 
and access comprehensive health and social services to improve the 
health of mothers and children before, during, and after pregnancy. 
Healthy Start targets communities with infant mortality rates that are 
at least 1\1/2\ times the U.S. national average and/or with high 
indicators of poor perinatal outcomes, particularly among non-Hispanic 
Black and other disproportionately affected populations. Healthy Start 
funds 100 competitive grants that reach 127 counties in 37 States and 
the District of Columbia.
    Another key program in improving maternal health outcomes is HRSA's 
Alliance for Innovation in Maternal Health Initiative (AIM). AIM seeks 
to prevent maternal deaths and cases of severe maternal morbidity by 
working with states and hospitals to implement maternal safety 
bundles--small, straightforward sets of evidence-based practices that, 
when performed collectively and reliably, have been proven to improve 
patient outcomes. AIM is working with 13 States and more than 667 
hospitals and targets complications including obstetric hemorrhage, 
severe hypertension, and venous thromboembolism, and also seeks to 
avoid low-risk primary cesarean births and reduce racial disparities 
associated with prenatal care. Additionally, HRSA is working to improve 
women's health prior to pregnancy by focusing on women's preventive 
services. Through a coalition of experts, HRSA maintains the Women's 
Preventive Services Guidelines which identifies certain preventive 
health screenings and services to be provided without cost-sharing. 
These guidelines help ensure women have access to standard level of 
care.
    Lastly, HRSA supports voluntary, evidence-based home visiting 
services during pregnancy and to parents with young children up to 
kindergarten entry through the Maternal, Infant and Early Childhood 
Home Visiting (MIECHV) Program. Among the ways the program seeks to 
improve the lives of children and families, the MIECHV program focuses 
on improving maternal and child health outcomes. In these voluntary 
programs, trained professionals meet regularly with expectant parents 
or families with young children in their homes, building strong, 
positive relationships with families who want and need support. MIECHV 
state and territory grantees provided nearly 4.2 million visits from 
fiscal year 2012 through fiscal year 2017. In fiscal year 2017 states 
reported serving more than 156,000 parents and children in 893 counties 
across all 50 States, the District of Columbia, and five territories. 
In addition, a recent report on maternal mortality review committee 
data showed mental health conditions (including substance use 
disorders) to be one of the leading causes of pregnancy-related death. 
The MIECHV Program supports mothers who experience depression by 
providing support, resources and referrals, as needed. In fiscal year 
2016, 44 States reported comparable data on maternal depression. The 
overall screening rate among these 44 States was 82 percent, with 15 
States reporting screening rates of 95 percent or more.
    Question. Do you believe that the Medicaid program should cover 
postpartum care for longer than the currently required 2 months?
    Answer. We are committed to making sure the right patient gets the 
right treatment at the right time. While the Federal Government 
establishes general guidelines for Medicaid, states design, implement 
and administer their own programs. HHS believes that States understand 
best the unique needs of their residents and has committed to restoring 
balance to the Federal and State partnership. Through our Maternal and 
Infant Health Initiative, which is designed to improve the rate and 
content of postpartum visits and increase the use of effective methods 
of contraception among women in Medicaid and CHIP, CMS works to provide 
States with the information they need to inform their policies. Through 
this initiative, CMS has offered states several reports, webinars, and 
opportunities to share best practices. In addition, to support HHS's 
maternal and perinatal health-focused efforts, CMS recently identified 
a core set of measures for voluntary reporting by state Medicaid and 
CHIP agencies that will be used by CMS to measure and evaluate progress 
toward improvement of maternal and perinatal health in Medicaid and 
CHIP.
                   opioids/cdc guidelines for doctors
    Question. Pharmaceutical companies bear the lion's share of blame 
for today's opioid epidemic--for misleading doctors and the public 
about the risks of opioids and for over-producing prescription 
painkillers (14 billion). But from there, opioids get to Americans from 
a prescription pad--for every 100 patients who receive a one-week 
opioid prescription, 9 of them will still be taking opioids 1 year 
later.
    Four out of five recent heroin initiates report prior nonmedical 
pain reliever use. The CDC recognizes that the medical community must 
be part of the solution and employ more responsible opioid prescribing. 
The CDC released the ``Opioid Prescribing Guidelines for Chronic 
Pain,'' a guideline that was sent to every practitioner nationwide. 
These guidelines are clear--they state: ``in general, do not prescribe 
opioids as the first line treatment,'' and recommend ``less than 3 day 
supply for acute pain.''
    Should opioid prescribers have to go undergo mandatory training on 
the latest knowledge about the risks and benefits of opioids?
    Answer. The Department is engaging on multiple fronts with respect 
to education of healthcare providers, and in particular, prescribers, 
on the risks and benefits of opioids.
    CDC supports the education of prescribers on the risks and benefits 
of opioids as well as safe and effective pain management, including the 
recommendations included within the CDC Guideline. While enacting and 
executing decisions around mandatory education of providers falls 
outside of CDC's purview as an agency, CDC would encourage the 
widespread dissemination and education of safer opioid prescribing 
practices given that such guidance is informed by the best available 
scientific data. The ways in which CDC encourages the uptake and use of 
the recommendations within the Guideline include the sharing of the 
Guideline document itself, as well as other resources developed through 
various channels. CDC has created an interactive training series and a 
webinar series for healthcare providers that offer the ability to earn 
continuing education credits. The interactive, web-based training 
features self-paced learning, case-based content, knowledge checks, and 
integrated resources to help healthcare providers gain a deeper 
understanding of the Guideline. Another way in which CDC is working to 
operationalize Guideline recommendations within clinical practice is 
through the development and piloting of Guideline-informed quality 
improvement (QI) measures. CDC has developed voluntary QI measures, 
aligned with the recommendations contained in the Guideline, which are 
intended to support practice improvement for primary care practices by 
tracking opioid prescribing and providing feedback to clinicians 
through a data dashboard.
    CDC-funded state health departments also are involved with a wide 
breadth of work related to provider outreach and education. One 
particular strategy to align opioid prescribing practices with 
Guideline recommendations is to implement academic detailing, a 
practice where unbiased and evidence-based information is presented to 
medical providers to affect behavior change. The in-person and one-on-
one academic detailing session is based on principles of social 
marketing and the health behavior model. Across CDC's program 
portfolio, each funded state has different programmatic goals and 
resources for planning and implementing provider outreach and 
education. Currently, about a third of the states funded through CDC's 
Prevention for States program are engaging in work that use the 
principles of academic detailing as a model to drive behavior change 
among providers.
    Specific to medical education, CDC sees a benefit in facilitating 
the use and uptake of the Guideline within curricula across the 
continuum of medical education, including medical education programs, 
residency training and transition into the clinical workforce, and 
continuing medical education. Shortly following the release of its 
Guideline, CDC engaged with 60 medical schools that previously had 
pledged to incorporate some aspect of the Guideline within their 
respective educational curricula for the forthcoming academic year. 
While the discussions were beneficial, CDC learned that each academic 
institution operates very differently and that there is inherent value 
for organizations to share and learn promising strategies from their 
peers, as opposed to from CDC as a Federal entity.
    To that end, CDC has newly initiated work toward the planning and 
implementation of a convening of leaders across the continuum of 
medical education, in order to highlight best practices and strategies 
in aligning curricula, training, and continuing education with safer 
opioid prescribing practices, including those enumerated within the 
Guideline. CDC aims to engage leaders and program directors who 
represent entities across undergraduate and graduate medical education, 
residency training programs, and faculty continuing medical education 
programs. Such individuals may include, but may not be limited to, 
those at the highest level of leadership (i.e., Deans of Medical 
Schools, Heads of Residency Programs), those who direct curricula 
development and implementation, and any others who make decisions on 
behalf of entities whom we would want to engage through this work. As a 
result of this convening, CDC would aim to have in place an 
implementation guide highlighting strategies across the continuum of 
medical education and clinical training that would be of value to the 
broader field. Additional outcomes would also include increasing CDC 
knowledge and insight on how current Guideline translational tools and 
resources are used and how CDC can address remaining gaps with future 
materials, as well as determining the needs of educators on the front 
lines of medical education on how best to integrate safer opioid 
prescribing practices within curricula.
    In addition to external entities mentioned above, CDC also 
regularly collaborates with Federal partners to implement the Guideline 
and to ensure alignment across the Federal landscape. For example, the 
Department of Veterans Affairs, Department of Defense, and the Indian 
Health Service released an updated clinical practice guideline for 
opioid therapy for chronic pain based in part on the CDC Guideline. The 
Centers for Medicare & Medicaid Services (CMS) has also changed program 
quality measures and Medicare's Merit-based Incentive Payment System 
quality measures to be consistent with the Guideline (e.g., on high-
dose opioid prescribing, review of PDMP data). CDC shares updated 
Guideline resources and educational materials with fellow agencies that 
can help inform their efforts. These collaborations extend to its 
partners in public safety as well. Earlier this year, DEA sent an email 
notification to 1.7 million registrants to encourage Guideline-
concordant care among providers.
    FDA's Opioid Policy Steering Committee is currently considering the 
issue of whether opioid prescribers should have to undergo mandatory 
training, taking into account comments it has received from two recent 
FDA public hearings on the opioid crisis. FDA recently announced its 
plans to expand the risk management plans (known as Risk Evaluation and 
Mitigation Strategies, or REMS)--with which it requires the 
manufacturers of certain opioids to comply--to incorporate, for the 
first time, all opioid analgesics that are intended for use in the 
outpatient setting, including the immediate-release formulations. FDA 
has revised the associated Blueprint for how providers should be 
educated about prescribing opioids, and it is requiring this training 
be made available to all providers likely to come into contact with 
patients who are prescribed these medicines, including nurses and 
pharmacists.
    In addition to changing their quality measures, CMS has undertaken 
a number of other steps to help decrease opioid prescribing and to 
educate providers about the risks to beneficiaries. In the 2019 
Medicare Parts C and D Final Call Letter, CMS finalized a new policy 
that requires Part D sponsors to implement a hard safety edit to limit 
initial opioid prescription fills for the treatment of acute pain to no 
more than a 7 days' supply for opioid naive beneficiaries. For chronic 
opioid users, CMS finalized the expectation that all sponsors implement 
real-time safety alerts at the time of dispensing as a proactive step 
to engage both patients and prescribers about overdose risk and 
prevention, including use of a new opioid care coordination edit at 90 
morphine milligram equivalent (MME) per day and additional soft safety 
edits to alert the pharmacist about duplicative opioid therapy and 
concurrent use of opioids and benzodiazepines. The care coordination 
edit and other opioid-related strategies implemented for Part D 
beneficiaries finalized in the Call Letter support adoption of the CDC 
Guideline for Prescribing Opioids for Chronic Pain. Through parallel 
rule-making, CMS also implemented the provisions of the Comprehensive 
Addiction and Recovery Act of 2016 (CARA) that provide for a drug 
management program under which Part D sponsors will be able to limit 
at-risk beneficiaries' coverage for frequently abused drugs to certain 
prescribers and pharmacies (``lock-in''). In addition, CMS has sent 
24,000 letters to Medicare physicians that were prescribing at higher 
rates than their peers. CMS is also working to promote effective, 
alternative pain treatments that are not as addictive as opioids, 
including by disseminating best practices guidance to state Medicaid 
agencies. These actions and many more will be taken as part of CMS's 
three part response to the opioid epidemic, focusing in prevention, 
treatment, and data.
    With the increases received in fiscal year 2018 for opioids, HRSA 
will support current Behavioral Health Workforce Education and Training 
grantees who partner with health centers to develop integrated, 
interprofessional care teams to improve access to opioid use disorder 
and other substance use disorder treatment.
                                 ______
                                 
                Questions Submitted by Senator Jack Reed
    Question. Preserving funding for the Low Income Home Energy 
Assistance Program (LIHEAP) has been a bipartisan priority that I have 
been proud to work on each year with my colleague from Maine, Senator 
Susan Collins. While this Administration has proposed eliminating this 
vital program, I was pleased that the recent Omnibus appropriations law 
provided an additional $250 million, and that HHS promptly distributed 
those funds to states.
    Do you intend to continue HHS' longstanding commitment to ensuring 
that vulnerable households have access to home energy assistance? Will 
you also commit to distributing these funds to states as quickly and at 
as high a level as possible, based on Congressional appropriations?
    Answer. The HHS Budget proposed the elimination of this program to 
prioritize funding for other human services activities. LIHEAP is not 
the only program helping low-income households pay their heating and 
cooling bills. State and local governments provide significant funding 
assistance, and the majority of states prohibit utilities from 
discontinuing a household's energy in periods of severe weather.
    Once LIHEAP funds are appropriated, HHS is committed to 
distributing them as quickly as possible. The fiscal year 2018 Omnibus, 
included $3.6 billion for LIHEAP, an increase of $250 million above the 
fiscal year 2017 appropriation. All remaining fiscal year 2018 LIHEAP 
funding was released to states on April 23, 2018.
    Question. The child welfare community in Rhode Island is 
enthusiastic about the opportunity to transform the approach to foster 
care through the Families First Prevention Services Act. When does the 
Department plan to issue regulations or guidance to implement the new 
law?
    Answer. We intend to provide maximum flexibility to states in our 
implementation of Families First. As such, we will use subregulatory 
guidance in order to transmit instructions to states and tribes on how 
to comply with the changes whenever possible. We expect to issue such 
guidance in the form of Program Instructions (PI) as soon as July on 
the title IV-B and Chafee programs, the changes to the title IV-E 
Foster Care Maintenance Payments (FCMP) Program, the title IV-E 
Adoption Assistance phase-in delay, and the optional effective date 
delays. HHS will implement the title IV-E Prevention Services Program 
through PIs that we expect to publish in the first quarter of Federal 
fiscal year 2019, most likely near the end of this calendar year.
    Question. What are the plans for technical assistance to help 
states build the capacity and infrastructure to implement it?
    Answer. ACF's implementation plan includes the provision of 
training and technical assistance to states as we roll out guidance 
over the summer. For example, SAMHSA and ACYF jointly fund the National 
Center on Substance Abuse and Child Welfare, which is available to 
assist states with developing collaborative practices to expand access 
to family-centered treatment services on a system-wide basis.
    Question. There have been recent reports that the Department of 
Health and Human Services is making arrangements to house migrant 
children on military bases in anticipation of an increase of 
unaccompanied immigrant minors due to the Administration's new policy 
to separate children of asylum seekers from their parents. Please 
provide details of the Department's discussions with the Department of 
Defense and the Department of Homeland Security on these plans, 
including the legal authority to separate families, detain children, 
and hold them in custody in this manner.
    Answer. HHS's authority extends only to children that meet the 
legal definition of an unaccompanied alien child found at 6 U.S.C. 
279(2) as determined by DHS. HHS defers to DHS concerning the 
separation of families. HHS's authority for, and obligation with 
respect to, the care and custody of UAC is found in the Homeland 
Security Act of 2002 and the Trafficking Victims Protection 
Reauthorization Act of 2008. Under these statutes, and in accordance 
with the Flores v. Reno Settlement Agreement, HHS may place children in 
temporary emergency shelters, which may include temporary shelters 
located on a military installation, when there is a situation where 
HHS's normal bed capacity is overwhelmed. The policies governing an 
influx can be found in Section 1.7 of the ORR Guide: Children Entering 
the United States Unaccompanied. ORR will examine other available non-
DoD installation options before attempting to open an influx care 
facility on DoD property.
    Question. Has the Department estimated how many children will be 
placed in its custody?
    Answer. We are closely working with our DHS partners to plan for 
expansion of program capacity, similar to activities in past years when 
large numbers of unaccompanied alien children (UAC) were referred to 
ORR for care. The UAC program will consider potential impacts, 
including number of UAC referrals, length of stay in our care, capacity 
needs, and cost estimates. As always, this program is very 
unpredictable and we will continue to work with Congress as we learn 
more.
    Question. What accommodations are being considered for young 
children and minors with special needs?
    Answer. HHS has policies in place to ensure that all children in 
its care have their needs met. HHS does not place children under the 
age of 13 or a child with special needs in an emergency influx care 
facility.
    Question. What are the potential impacts on the children's health 
and well-being from being forcibly separated from their parents and 
detained on a military base? Does the Department have a plan to 
mitigate these impacts?
    Answer. HHS works to ensure that each UAC's needs are met while 
they are in the care of the agency. All care facilities have clinicians 
and case managers to provide support and counseling to UACs.
    Question. Does the department track and make available any data on 
negative health effects experienced by children who are separated from 
their parents and detained in this manner?
    Answer. ORR does not systematically track or make publicly 
available data on the health needs of UACs.
    Question. Do I have your commitment to spend these funds to expand 
the number of funded states and allow currently funded states to expand 
their lead poisoning prevention programs?
    Answer. The fiscal year 2018 Omnibus provided $35 million in 
funding for CDC's Childhood Lead Poisoning Prevention Program, 
representing an $18 million increase over fiscal year 2017. In fiscal 
year 2017, CDC funded a total of 48 funded programs from 38 States, 5 
large cities, 4 counties, and the District of Columbia. In fiscal year 
2018, CDC anticipates funding additional state, local, territorial, or 
tribal agencies, as well as providing supplemental funding to enhance 
activities for the 48 existing funded programs for the following four 
lead poisoning prevention strategic activities related to:
  1. Strengthening blood lead testing
  2. Strengthening surveillance
  3.  Strengthening linkages to ensure children exposed to lead receive 
        appropriate follow-up services
  4. Strengthening population-based interventions
    Question. My bipartisan legislation with Senators Capito and 
others, the Childhood Cancer Survivorship, Treatment, Access, and 
Research (STAR) Act, recently passed the Senate. Should this 
legislation be passed by the House and signed into law, as is expected, 
how do you plan to implement the STAR Act's provisions to do expand 
biorepositories, improve surveillance of childhood cancer, develop best 
practices for the treatment of late effects of childhood cancers, 
improve collaboration among providers so that doctors are better able 
to care for this population as they age, and create innovative models 
of care for childhood cancer survivors establish. Will you join us in 
supporting funding for the initiatives authorized in the legislation?
    Answer. Thank you and your colleagues for your leadership and 
support for childhood cancer research. HHS appreciates that the STAR 
Act aims to build upon and complement childhood cancer research and 
programs already underway with HHS support, including at the National 
Institutes of Health (NIH), the National Cancer Institute (NCI), and 
the Centers for Disease Control and Prevention (CDC). If the STAR Act 
is signed into law, HHS will certainly work to implement its provisions 
to the best of our ability with the funds made available to us by 
Congress.
    HHS remains committed to advancing progress for childhood, 
adolescent, and young adult cancer patients and survivors and their 
families. NIH and NCI will continue to support critical investments in 
childhood cancer survivorship research, including the Childhood Cancer 
Survivor Study; and pediatric biospecimen collection and related 
resources, including the Children's Oncology Group Biorepository and 
the Pediatric Cooperative Human Tissue Network. CDC will continue to 
support and improve surveillance on childhood, adolescent, and young 
adult cancers through its National Cancer Registries Program. Research 
supported by NCI and other NIH Institutes and Centers will continue to 
inform best practices in long-term pediatric cancer survivorship care, 
including the treatment and management of the late effects of cancer 
therapy. HHS will leverage pediatric oncology expertise across our 
operating divisions to review HHS activities related to workforce 
development for healthcare providers who treat pediatric cancer 
patients and survivors.
                                 ______
                                 
             Questions Submitted by Senator Jeanne Shaheen
    Question. I continue to be concerned by the Department's proposal 
to increase the availability of so-called ``short-term, limited-
duration insurance plans'' that are not required to meet consumer 
protection and comprehensive coverage requirements under the Affordable 
Care Act. These insurance policies are not required to cover 
preexisting conditions, are not required to cover essential health 
benefits and can charge sick patients more in premiums.
    Given the likelihood for consumer confusion resulting from the 
availability of these skimpy insurance products, will the Department 
consider restoring the advertising and consumer outreach funding for 
Health Insurance Marketplace coverage that was reduced by 90 percent 
last year?
    Answer. The federally-Facilitated Exchange will conduct its sixth 
Open Enrollment later this year. The Exchange is now an established 
marketplace for individuals seeking insurance. Last year we had our 
most cost effective and successful open enrollment to date. The 
Exchange has grown in visibility and become more familiar to Americans 
seeking health insurance. CMS spent more than $100 million on 
promotional activities during Open Enrollment 2017 (nearly double what 
was spent in 2015) but saw enrollments decline by 10 percent since the 
previous year.
    The Health Insurance Marketplace advertising budget is now 
consistent with its advertising spending for Medicare Part D and 
Medicare Advantage. As a comparison, 11.8 million consumers selected or 
were re-enrolled in an Exchange plan during Open Enrollment 2018, while 
41.3 million Americans are enrolled in Medicare Part D and another 19.1 
million are enrolled in Medicare Advantage. CMS's combined advertising 
budget for Medicare Parts C and D is $9.7 million.
    CMS will continue to leverage the capabilities of the private 
sector as well to ensure our partners, such as agents and brokers, are 
equipped with the necessary resources to educate consumers on their 
coverage options.
    Question. I worked with Senator Collins on the bipartisan National 
Clinical Care Commission Act, which President Trump signed into law 
last year. I appreciate the Department's recent efforts to approve the 
charter for the National Clinical Care Commission and to seek nominees 
for the Commission. Can you provide any additional information on the 
Department's timeline for finalizing Commission membership and 
providing additional regulatory guidance on the Commission's 
activities?
    Answer. The Office of Disease Prevention and Health Promotion is 
coordinating the efforts of the National Clinical Care Commission. The 
final nominations are expected by the end of June.
    Question. The fiscal year 2019 budget request would eliminate 
funding for the Prevention Research Center program within the Centers 
for Disease Control and Prevention (CDC). I am concerned about the loss 
of this funding and the potential impact on the important work 
conducted by academic and medical research centers in New Hampshire, 
especially in relation to seniors with health needs and individuals 
with mental health issues and substance use disorders. How does the 
Department of Health and Human Services (HHS) plan to fill this void if 
the funding is cut?
    Anwer. The fiscal year 2019 Budget eliminates funding for the 
Prevention Research Centers (PRCs), which work with academic 
institutions to conduct research and disseminate prevention 
interventions across the United States. In fiscal year 2018, CDC will 
fund PRCs at 26 universities in 24 States to study how individuals and 
communities can avoid or counter the risks for chronic illnesses. The 
PRC program has developed and evaluated many effective, practical 
public health strategies and programs, which can continue to be 
disseminated throughout the country. CDC's chronic disease prevention 
portfolio will continue to focus on implementation of the most 
effective existing interventions, working with community organizations 
and state and local public health agencies.
    Question. The role of HHS in administering global health funding, 
including HIV/AIDS funding, means that the Department is responsible 
for implementing components of the expanded ``global gag rule,'' also 
known as the ``Mexico City Policy.'' HHS participated in the State 
Department's initial review of the policy earlier this year, but the 
majority of HHS grants and cooperative agreements had not received new 
funding at the time of review. How are agencies within HHS monitoring 
the effect of this policy on women's access to healthcare, including a 
full range of family planning methods and counseling, rates of unsafe 
abortion and maternal mortality?
    Answer. To assess the impact of the policy on HIV/AIDS services, 
the President's Emergency Plan for AIDS Relief (PEPFAR) will continue 
its routine capture, monitoring, and use of age and sex disaggregated 
data, by partner and by site, to track precisely whether and to what 
extent the Protecting Life in Global Health Assistance (PLGHA) policy 
may affected life-saving activities related to HIV/AIDS. The Department 
of State has worked closely with USAID, HHS, and DoD to implement the 
policy consistently, examine progress in carrying it out, and monitor 
its effects.
    Question. I am very troubled that as of April 1st, halfway through 
the fiscal year, only 10,548 refugees have been resettled, just 23 
percent of this admissions determination and 73 percent fewer than the 
same time period last year. What measures are the Office of Refugee 
Resettlement (ORR) taking to maintain the capacity of refugee-serving 
organizations across the country to provide robust assistance for 
refugees and to ensure the long-term sustainability of the U.S. refugee 
resettlement network?
    Answer. ORR continues to use its current budget to support the 
resettlement agencies.
    Question. The fiscal year 2018 Consolidated Appropriations Act 
accepted the Administration's proposal to consolidate funding for 
Targeted Assistance, Refugee Health Promotion, and Refugee Social 
Services under one funding line. However, Congress explicitly stated 
that it expects activities previously funded under the three lines to 
continue in fiscal year 2018 at the same level as fiscal year 2017. How 
is ORR administering this funding to ensure that, in compliance with 
this Act, these programmatic activities continue at the same level as 
fiscal year 2017?
    Answer. ORR will ensure funding levels for Social Services, 
Targeted Assistance, and Refugee Health Promotion will be funded as 
close to possible to fiscal year 2017 levels within the current budget.
    Question. The fiscal year 2018 Consolidated Appropriations Act also 
includes language in Senate Report 115-150 strongly encouraging HHS to 
increase the percentage of eligible arrivals served by the matching 
grant program and to give matching grant organizations flexibility in 
administering their programs. How is ORR implementing this guidance 
from Congress?
    Answer. As a result of a lower number of refugee arrivals, grantees 
are able to offer enrollment to all eligible individuals at the 
locations where the program is available. Additionally, and for the 
first time since 2007, the per-capita funding amount has increased to 
$2,500 from $2,200. The required grantee match also increased to 
$1,250. Finally, ORR continuously assesses and makes adjustments to 
program guidelines to ensure enrolled individuals receive high quality 
services leading to economic self-sufficiency while affording the 
grantees the flexibility to innovate in service delivery.
    Question. Due to this Administration's newly-announced policy to 
separate all children from their parents when apprehended by Customs 
and Border Protection (CBP). How many additional children does ORR 
anticipate serving in fiscal year 2018 who have been separated at the 
border from their parents?
    Answer. We are closely working with our DHS partners to understand 
the potential impacts of their new policy on the UAC program including 
number of referrals, length of stay in our care, capacity needs and 
cost estimates. As always, this program is very unpredictable and we 
will continue to work with Congress as we learn more.
    Question. How does this number compare with ORR's existing capacity 
to serve unaccompanied children?
    Answer. ORR will expand its capacity to provide shelter and care to 
UACs as needed.
    Question. What is the estimated cost to the taxpayer of holding 
these additional children under ORR custody?
    Answer. We are closely working with our DHS partners to understand 
the potential impacts of their new policy on the UAC program including 
number of referrals, length of stay in our care, capacity needs and 
cost estimates. As always, this program is very unpredictable and we 
will continue to work with Congress as we learn more.
    Question. How does ORR plan to coordinate with DHS and DOJ to 
ensure continued communication and eventual reunification between 
parents and the children separated from them at the border and placed 
under ORR custody?
    Answer. ORR is collaborating with DHS and DOJ to make sure that 
children who can be reunified with their parents are reunified in a 
timely and safe manner. ORR and DHS havedeveloped and issued a notice 
to clearly inform parents about how to contact their children in ORR's 
custody. ORR is also working with care providers to help link children 
to parents in detention.
                                 ______
                                 
              Questions Submitted by Senator Jeff Merkley
    Question. In April, press reports indicated that the Center for 
Medicare and Medicaid Services had refused to grant requests from 
tribal governments to exempt tribal members from Medicaid work rules. A 
``Dear Tribal Leader'' letter and subsequent related statements made by 
HHS personnel on the issue of American Indian and Alaska Native (Al/AN) 
exemption from Medicaid work requirements revealed a startlingly poor 
understanding of the unique legal status of Indian tribes and their 
members under Federal law, the U.S. Constitution, treaties, and the 
Federal trust relationship.
    While I was encouraged to see that CMS dropped its erroneous claim 
that exempting tribes from work requirements raised civil rights 
issues, I remain concerned that CMS' deference to state agencies on 
this issue represents a further erosion of the principle of tribal 
sovereignty and an abdication of the Federal Government's trust 
responsibilities.
    I request that you provide the Committee with the following 
information:
    How much in Medicaid reimbursements did tribal and IHS providers 
receive in the last year for which data is available?
    Answer. IHS can only provide information about Federal Medicaid 
reimbursements. Tribal entities who have exercised self-determination 
directly receive their Medicaid reimbursements and are not required to 
report them to the IHS. For the most recent complete year, fiscal year 
2017, IHS' Federal Medicaid collections were: $259,886,004.
    Question. As you know, the U.S. Government has a trust 
responsibility to provide healthcare to Native Americans. If a state 
were to impose a work requirement and knock a significant population of 
Native Americans off of Medicaid, how would HHS address the resulting 
revenue gap for tribal and IHS providers and ensure that they can 
continue treating their patient populations?
    Answer. The Department is working with states that want to 
implement Medicaid community engagement requirements to ensure that the 
requirements are reasonable, achievable, and tailored to the goal of 
promoting positive health outcomes for beneficiaries. For instance, the 
Department has worked with states to include program features such as: 
permitting Medicaid beneficiaries to engage in a broad range of 
activities to satisfy the requirements (such as community service on or 
off tribal lands, participation in workforce participation programs 
including tribal workforce participation programs, caring for children 
or for family members with disabilities and medical conditions, or 
participating in substance abuse treatment); exempting from the 
requirements various individuals (such as those in substance use 
disorder treatment or rehabilitation, or those caring for family 
members); and requiring states to provide a range of reasonable 
accommodations to participants with disabilities so they can meet 
requirements or be exempted from them if they are unable to do so.
    Question. Given that providing healthcare to Indian people is a 
Federal responsibility, which is codified through numerous Federal laws 
and treaties, why is it appropriate that States determine how Indian 
people are treated?
    Answer. The Indian Health Service, a Federal program, is the 
healthcare system for many American Indians and Alaska Natives. Members 
and descendants of a federally recognized tribe are eligible to receive 
care at IHS facilities.
    Medicaid is also an important source of health coverage for 
American Indians and Alaska Natives, but that program is administered 
by states, subject to Federal approval. The Social Security Act allows 
states to propose Medicaid demonstration projects to test innovative 
ways of designing and administering their state Medicaid programs. 
Given that Medicaid is a state-administered program, the Department 
requires states to consult with tribes and seek their advice on how 
state demonstration projects, including any community engagement 
requirements, would be implemented with respect to tribal members who 
are Medicaid beneficiaries. This longstanding policy recognizes the 
sovereign nature of the tribes by requiring government-to-government 
consultation.
                                 ______
                                 
              Questions Submitted by Senator Brian Schatz
       expanding access to telehealth for medicare beneficiaries
    Question. I was pleased to hear that you would be ``very forward 
leaning'' if you were to receive the authority from the CONNECT for 
Health Act to waive barriers to Medicare fee-for-service reimbursement 
for telehealth.
    Please provide an update on how HHS plans to support and use 
telehealth to expand provider networks, improve access, and lower the 
cost of care.
    Answer. Telehealth can provide innovative means of making 
healthcare more flexible and patient-centric. Innovation within the 
telehealth space could help to expand access to care for Medicare 
beneficiaries, particularly within rural and underserved areas. We are 
working to implement the provisions of the Bipartisan Budget Act of 
2018 that support greater access to telehealth services for Medicare 
beneficiaries in the areas of home-based dialysis care, stroke care, 
and care from certain Accountable Care Organizations.
    The Centers for Medicare & Medicaid Services (CMS) has previously 
sought information regarding ways that it might further expand access 
to telehealth services within its current statutory authority, and pay 
appropriately for services that take full advantage of communication 
technologies. CMS has been reviewing comments and considering 
commenters' suggestions for future rulemaking and any appropriate sub-
regulatory changes. Furthermore, in their Calendar Year 2018 Medicare 
Physician Fee Schedule Final Rule \7\ released last November, CMS 
expanded access to Medicare telehealth services by paying for more 
services through new additions to the list of Medicare telehealth 
services and making it easier for physicians and practitioners to bill 
for these services.
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    \7\ https://www.gpo.gov/fdsys/pkg/FR-2017-11-15/pdf/2017-23953.pdf.
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    In addition, in May 2018, CMS released the agency's first Rural 
Health Strategy, intended to provide a proactive approach on healthcare 
issues to ensure that the nearly one in five individuals who live in 
rural America have access to high quality, affordable healthcare; one 
of the five objectives of this strategy is to advance telehealth and 
telemedicine. In continued collaboration with CMS, agencies across HHS, 
including the Health Resources and Services Administration (HRSA), will 
work to implement this strategy. Improving access to telehealth 
services reflects CMS's work to modernize Medicare payments to promote 
patient-centered innovations. HHS looks forward to continuing its work 
with Congress and other stakeholders to identify additional ways in 
which it can further expand access to telehealth services within 
Medicare and reduce the administrative burden for healthcare providers 
to bill for these services.
                   telehealth and medicare advantage
    Question. With the passage of CONNECT for Health Act provisions in 
the Bipartisan Budget Agreement of 2018, Medicare Advantage 
organizations can account for telehealth services in their 2020 bids. 
Currently, in the Medicare Managed Care Manual, the Centers for 
Medicare and Medicaid Services (CMS) lists ``Telemonitoring,'' ``Remote 
Access Technologies,'' and ``Enhanced Disease Management'' as examples 
of possible supplemental benefits.
    Are you planning to revise the Medicare Managed Care Manual to 
clarify that the use of remote monitoring and telehealth to deliver 
chronic care management services is a basic benefit rather than a 
supplementary benefit?
    Answer. As part of the Balanced Budget Act of 2018, Congress 
passed, and the President signed into law, changes that will allow 
Medicare Advantage (MA) plans to offer additional telehealth benefits 
beyond those currently paid for in Medicare Part B (Fee-for-Service), 
starting in 2020. CMS knows that it is important that plans and 
beneficiaries have accurate and timely information about these changes 
in time for the 2020 plan year. As it does regularly when there are 
changes in Medicare Advantage, CMS will update the Medicare managed 
care manual to reflect those changes, as well as announcing the policy 
changes in the annual MA Call Letter.
    Question. Please provide an update on how CMS plans to address this 
imbalance. Is CMS willing to make a case-by-case adjustment as it did 
with Puerto Rico?
    Since Medicare Advantage penetration continues to grow, will CMS 
correct the fee-for-service spending calculation for all Medicare 
Advantage organizations to be more accurately representative of the 
expected spending for Medicare Advantage beneficiaries?
    Answer. HHS is aware that areas of the country in which there are a 
higher proportion of beneficiaries who do not have Part B compared to 
the rest of the nation, such as Hawaii, face different challenges than 
those areas of the country that do not have a similar population. This 
Administration is committed to promoting healthcare choice and 
competition across the United States, and Medicare Advantage plays an 
important role in our efforts. HHS is open to having a conversation 
with stakeholders in Hawaii in order to better understand the unique 
challenges they face. CMS will continue to analyze this issue and 
consider whether any adjustments to the methodology on this point may 
be warranted in future years.
                                 ______
                                 
              Questions Submitted by Senator Tammy Baldwin
    Question. President Trump recently signed my bipartisan RAISE 
Family Caregivers Act (Public Law115-119) into law, which I authored 
with my colleague Senator Collins. This new law would formally 
recognize and support the over 40 million family caregivers who are 
overlooked in our healthcare system. It helps ensure that older adults 
and loved ones with disabilities receive the highest quality care in 
their own homes. Every day, family caregivers do right by their loved 
ones, and I'm proud to say that we're now doing right by them. But, in 
order to fulfill this promise, it is essential that you begin swift 
implementation of the law by immediately establishing the Family 
Caregiving Advisory Council that is charged with providing you timely 
advice to inform the national Caregivers Strategy.
    Will you agree to work with me and Senator Collins to support 
family caregivers by swiftly and faithfully implementing this measure?
    Answer. The RAISE Family Caregivers Act requires the Department to 
promote improvement of the Federal, State and community systems that 
support family caregivers. The two primary functions of the RAISE Act 
are to: (1) establish a national Family Caregiving Strategy with 
recommendations for ensuring person- and family-centered care, 
assessment and service planning, information on accessing hospice and 
palliative care, respite options, financial security and workplace 
issues, and delivering service in an effective and efficient manner; 
and (2) establish a Family Caregiving Advisory Council of Federal and 
non-Federal representatives to provide recommendations and identify 
best practices to recognize and support family caregivers.
    The Act did not authorize the creation of new programs or services, 
and specified that work should be accomplished within existing 
resources. The Department has been exploring all options for 
implementing the Act with existing HHS authorities and appropriations.
    Question. Will you commit to establishing the Advisory Council 
immediately in fiscal year 2018?
    Answer. The RAISE Act did not authorize an appropriation for the 
creation of new programs or services, and specified that work should be 
accomplished within existing resources. HHS has sought but not yet 
identified existing authorities and appropriations that would allow the 
Department to proceed with implementation of the Act.
    Question. Last year in China, 192 people contracted the H7N9 strain 
of avian influenza and 79 died. While that virus is not jumping from 
birds to humans with a great rate of frequency, reports indicate that 
the CDC remains concerned. Recent studies show that the virus is only 
several mutations away from being able to easily spread from human to 
human, which could ignite a deadly global pandemic. It is essential--
and one of my top priorities to help ensure--that our country is 
prepared to take on this serious health threat before it arrives. The 
Assistant Secretary for Preparedness and Response recently released the 
Public Health Emergency Medical Countermeasure Enterprise budget, which 
called for $632 million for fiscal year 2019 for pandemic influenza. 
However, your HHS fiscal year 2019 Budget only requests $250 million. 
Can you explain this gap in requested funding, and what HHS is doing to 
ensure our Nation is prepared for this known health threat that may be 
only a plane ride away?
    Answer. The Public Health Service (PHS) Act, as amended by the 
Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 
(PAHPRA), requires the Office of the Assistant Secretary for 
Preparedness and Response (ASPR) to lead the development of a 
coordinated 5-year budget plan for medical countermeasure (MCM) 
development and to update the plan annually. The 2016--2020 PHEMCE 
Multiyear Budget was transmitted to Congress and made publically 
available in December 2017.
    The report includes spending estimates for the HHS PHEMCE agencies 
(ASPR, CDC, FDA, and NIH) that are equal to actual appropriations in 
fiscal year 2016 and fiscal year 2017, the fiscal year 2018 President's 
Budget, and use a professional judgment budget to estimate potential 
investments for two future years (fiscal years 2019--2020). The 
spending estimates for fiscal year 2019 are considered a professional 
judgment budget, which were developed without regard to the competing 
priorities that are considered in the budget development process. These 
priorities must be considered as future President's Budgets are 
developed. The spending estimates included in the Multiyear Budget are 
subject to change in the future.
    The fiscal year 2019 President's Budget was transmitted to Congress 
this past March. The request included $250 million for pandemic 
influenza activities funded from the Public Health and Social Services 
Emergency Fund. This funding level represents an increase of nearly 
$200 million over the fiscal year 2017 appropriated level. The 
Department greatly appreciates the $250 million appropriated to the 
PHSSEF for pandemic influenza in the fiscal year 2018 Omnibus.
    ASPR continues to monitor the H7N9 strain of avian influenza. 
Through BARDA, ASPR has:
  --Responded to the 2017 H7N9 crisis, awarding three contracts for 
        production of approximately 20 million regimens of vaccine 
        antigen for H7N9 influenza vaccine from the 2016--2017 Yangtze 
        River virus lineage candidate vaccine virus provided by CDC to 
        achieve National Pre-Pandemic Influenza Vaccine Stockpile 
        preparedness goals; and
  --Supported a clinical study to assess the safety and antigen-sparing 
        capacity of adjuvants that are maintained in the National Pre-
        Pandemic Influenza Vaccine Stockpile, when combined with 
        recombinant-based vaccine for the 5th Wave/Yangtze River 
        lineage H7N9 influenza virus circulating China.
    Question. How are you ensuring we are utilizing new cell-based 
pandemic influenza technologies?
    Answer. HHS is committed to development of new vaccine 
technologies, in order to improve the Nation's ability to respond to an 
influena pandemic, as well as to address seasonal influenza. Since 
2010, BARDA has supported the licensure of both cell-based and 
recombinant influenza vaccine technologies. The new technologies have 
the potential to increase the U.S.'s manufacturing capacity and shorten 
the manufacturing timelines for seasonal and pre-pandemic vaccines. 
BARDA both utilizes these investments from a readiness and procurement 
stance, as well as continues to make targeted investments to further 
improve the Nation's preparedness posture. As part of BARDA/ASPR's 
pandemic influenza preparedness strategy, contracts are in place with 
all US licensed influenza vaccine manufacturers, including the 
manufacturers of recombinant and cell-based influenza vaccines, to 
allow production and delivery of vaccine to the United States 
Government in the event of a pandemic. BARDA has also purchased cell-
based pre-pandemic influenza vaccine for the pre-pandemic influenza 
vaccine stockpile (2013 H7N9 vaccine), and is currently supporting 
production, stability testing, and clinical trial evaluation of 
recombinant and cell based pre-pandemic influenza vaccines to inform 
future purchases. Finally, BARDA continues to fund advanced development 
of these technologies, particularly cell-based pandemic influenza 
technologies. This funding has supported development of a more 
efficient manufacturing process, which if approved by FDA, will 
translate into greater seasonal vaccine output and faster pandemic 
response.
    Question. The opioid epidemic has far-reaching and deadly public 
health impacts including the spread of infectious diseases. We have 
seen reports across the country of spikes in HIV cases linked to 
injected drug use, and the CDC estimates a 133 percent increase in 
acute HCV infection due to opioid use. While I am encouraged by the 
budget provisions that speak to the opioid crisis, I am concerned that 
this plan does not prioritize evidence-based public health resources, 
including access to primary care and preventive services, which will be 
needed to address outbreaks of infectious diseases. Can you describe 
how the Administration will emphasize the public health interventions, 
research, and workforce support necessary to prevent, track, and treat 
opioid-related infectious diseases?
    Answer. The rising rates of infectious diseases associated with 
injection drug use are of great concern.
    CDC is working to address bloodborne infectious diseases linked to 
intravenous drug use by sharing the best available science and 
approaches to prevent the spread of these diseases, getting people 
treated, and reducing the injection drug use that puts people at 
greater risk of getting infected. CDC is building state and community 
capacity for comprehensive approaches for preventing, tracking, and 
combating infectious diseases stemming from the opioid crisis by:
  --Collaborating to help states and communities track disease 
        patterns, determine if they are at risk for disease outbreaks, 
        and implement proven prevention strategies.
  --Providing technical assistance to state and local health 
        departments and community-based organizations on the most 
        effective strategies to engage people who inject drug, and 
        connect them to treatment and prevention services for drug use 
        and infectious diseases.
  --Using molecular surveillance to identify clusters of viral 
        hepatitis and HIV infections. This information can direct 
        prevention activities to stop disease transmission
    With additional resources provided to CDC in fiscal year 2018 for 
opioids, HHS will continue to expand and enhance its comprehensive 
public health response to the opioids crisis by working with state, 
territorial, and tribal health departments to address the full range of 
public health consequences of opioids, including infectious diseases.
    Similarly, with the increases provided in fiscal year 2018, HRSA 
will expand and improve access to opioid and substance use disorder 
treatment through the Community Health Centers and National Health 
Service Corps programs.
    In April 2018, the NIH launched the Helping to End Addiction Long-
term (HEAL) Initiative,\8\ to speed scientific solutions to stem the 
national opioid public health crisis. This Initiative will build on 
extensive, well-established NIH research, including basic science of 
the complex neurological pathways involved in pain and addiction, 
implementation science to develop and test treatment models, and 
research to integrate behavioral interventions with medication-assisted 
treatment for Opioid Use Disorder (OUD).
---------------------------------------------------------------------------
    \8\ https://www.nih.gov/research-training/medical-research-
initiatives/heal-initiative.
---------------------------------------------------------------------------
    In fiscal year 2019, the President's Budget includes a request for 
$40 million within CDC to eliminate new infections, and where relevant, 
decrease the prevalence of HIV, hepatitis B virus, hepatitis C virus, 
STIs such as syphilis, and tuberculosis in select states and 
jurisdictions at high risk for these diseases, including those with 
high rates of opioid-related transmission.
    Question. On February 23, 2018, HHS issued a delayed Funding 
Opportunity Announcement (FOA) for the Title X Family Planning Program. 
I am concerned that the language in this announcement indicates a shift 
from evidence-based, comprehensive family planning services toward 
abstinence-only-until-marriage education. Why was this FOA delayed, and 
what organizations does HHS plan to prioritize in awarding Title X 
grants, given these shifting priorities?
    Answer. HHS recognizes the FOA was delayed, but the current funding 
announcement streamlines the application process. This improvement 
makes it easier and more efficient for a wide variety of organizations 
to submit quality applications, enabling more women and men to receive 
excellent care through the Title X program. This funding announcement 
is now closed. Applicants have submitted their proposals and each will 
be subject to the same, objective assessment process. In addition, this 
FOA is currently the subject of litigation. As a result of both the 
ongoing litigation and the ongoing grant review process, HHS cannot 
comment at this time on future plans regarding the grant process or 
future awards.
    Question. Last year before the HELP Committee, the National Academy 
of Sciences said that pharmaceutical companies could easily absorb 
revenue losses from lower prices by reducing buyback programs and 
executive compensation, instead of reducing R&D, which is often 
threatened. If drug prices fell, do you think it would be right for 
drug companies to cut more from R&D than from buybacks and executive 
compensation? What do you think the majority of executives would 
choose?
    Answer. HHS recognizes that the current drug ecosystem requires 
dramatic change. The Administration understands that the drug pricing 
problem is complex and has multiple parts: high list prices, overpaying 
in government programs, high out-of-pocket costs, foreign governments' 
underpaying for drugs. They are connected in a way that attempting to 
squeeze one end of the balloon won't lead to lasting change and 
requires a broad-based, systematic approach to the problem.
    Recognizing these challenges, in May, the Administration released 
the ``American Patients First'' Blueprint, which will bring immediate 
relief to American patients while also delivering long-term reforms. 
There are four strategies for reform set out in the administration's 
drug-pricing blueprint: improved competition, lowering out-of-pocket 
costs, enhanced negotiation, and incentives for lower list prices.
    Question. Pharmaceutical executives receive an inordinate amount of 
their compensation in the form of stock-based pay. Over the last 10 
years, the top pharmaceutical companies spent an average of ninety-nine 
percent of their profits buying back their own stock and issuing 
dividends. Pharma's financialized business model draws heavily on 
taxpayer-funded investment in research. Yet drug company profits 
overwhelming benefit executives and wealthy shareholders. How will you 
ensure that American drug companies serve the taxpayers who have 
subsidized them and the public interest instead of just their 
shareholders?
    Answer. HHS is committed to getting more value for the prescription 
drugs that patients and taxpayers purchase. The Trump Administration 
has already taken a number of significant administrative steps. It 
proposed in the President's fiscal year 2019 Budget, to improve 
competition and end the gaming of regulatory processes, support better 
negotiation of drug discounts through government insurance programs, 
create incentives for pharmaceutical companies to lower list prices, 
and reduce consumer out-of-pocket spending at the pharmacy and other 
care settings. For example, FDA approved or tentatively approved over 
1,000 generic drugs in 2017, which is the greatest number of FDA 
generic approvals in a calendar year by over 200 drugs. These generic 
approvals saved American consumers and taxpayers nearly $9 billion in 
2017.
    In May, the Administration released the ``American Patients First'' 
Blueprint, which will bring immediate relief to American patients, 
while also delivering long-term reforms. The Blueprint proposes new 
strategies and takes bold actions to improve competition and end the 
gaming of regulatory processes, supports better negotiation of drug 
discounts through government insurance programs, creates incentives for 
pharmaceutical companies to lower list prices, and reduces consumer 
out-of-pocket spending at the pharmacy and other care settings.
    Question. In February 2018, the Administration released ``Reforming 
Biopharmaceutical Pricing at Home and Abroad.'' That report makes the 
baffling claim that American drugs prices are too high because drug 
companies' global financial returns are ``unfairly low'' [because 
foreign governments set lower drug prices]. In response, the report 
recommends that the U.S. force foreign governments to raise their drug 
prices, to make financial returns to U.S. pharmaceuticals `fair.' It is 
very clear to me what U.S. drug companies would do with additional 
profits--they would give them to their shareholders. The 18 
pharmaceutical companies in the S&P500 spent an average of ninety-nine 
percent of their profits on buybacks and dividends over the last 10 
years. Why does the Administration think that if drug companies got 
additional cash they would do anything other than reward their 
shareholders?
    Answer. HHS is committed to getting more value for the prescription 
drugs patients and taxpayers purchase. In May, the Administration 
released the ``American Patients First'' Blueprint, which will bring 
immediate relief to American patients, while also delivering long-term 
reforms. The many interacting drivers in the current pharmaceutical 
market, including growth in international price controls, have created 
an environment of high list prices and increased consumer out-of-pocket 
spending. The blueprint identifies four key strategies to realign the 
system: improved competition, better negotiation, incentives for lower 
list prices, and lowering out-of-pocket costs. Short and long term 
actions the Administration is taking on all of these fronts will bring 
relief to American consumers and taxpayers.
    Question. WHO is currently pushing countries to implement its 2016 
guidance related to the promotion of foods for infants and young 
children. The guidance would restrict communication about and promotion 
of milk products for children up to age three. This contradicts 
international and US dietary guidelines that recognize dairy products 
as an excellent source of nutrition for toddlers. How is the United 
States working at the WHO to promote good nutrition of and role of 
dairy in nutritious diets, in keeping with U.S. nutrition guidelines?
    Answer. The Administration agrees that more balanced approaches are 
needed to address nutrition issues, including improving nutrition among 
infants and children. At the 71st World Health Assembly (WHA) this May, 
the U.S. delegation successfully advanced this view in negotiating a 
resolution on infant and young child feeding. The U.S. delegation 
emphasized developing, implementing and evaluating evidence-based 
recommendations; WHO technical support to Member States upon request; 
and the importance of taking into account national context in 
determining which voluntary approaches, policies, or mandatory 
approaches to apply. In addition, the U.S. delegation successfully 
negotiated out of the resolution any direct references to the 2016 WHO 
guidance.
    In 2016, the 69th World Health Assembly (WHA) adopted a resolution 
welcoming the World Health Organization (WHO) Guidance on Ending the 
Inappropriate Promotion of Foods for Infants and Young Children. In the 
U.S. statement on the resolution--and in subsequent interactions with 
WHO, with other Member States, and with other stakeholders--the United 
States government emphasized improving nutrition among mothers, infants 
and young children as an important public health priority; that 
children over 6 months of age need nutrient-rich complementary foods 
from a variety of sources; and the importance of this time period for 
child health and development.
    The WHO guidance does not seek to prohibit the marketing of all 
milk products consumed by young children, limit product availability, 
or discourage the general inclusion of age-appropriate dairy products 
such as milk, cheese and yogurt in the diets of young children. WHO 
intends the guidance to complement, not replace, domestic and global 
recommendations for feeding infants and young children, including 
current recommendations on feeding breastfed and non-breastfed infants 
and young children. The document does recommend that countries prohibit 
the promotion of breast-milk substitutes marketed for feeding children 
up to 3 years of age. The voluntary guidance is a technical document 
and is not binding on Member States or on other actors. U.S. 
departments and agencies regularly interact with WHO, other Member 
States, and stakeholders to urge the development of evidence-based 
guidelines, tools and recommendations, applied according to national or 
local context, in order to improve nutrition. HHS continues to lead 
processes, in coordination and collaboration with the U.S. interagency, 
to solicit and provide evidence-based feedback to WHO on its nutrition 
work, and to convey the importance of providing countries with clear, 
evidence-based recommendations.
    Question. Vaccines are among the most cost-effective clinical 
preventive services, however, outbreaks of diseases that were once 
nearly insurmountable in the U.S. are again threatening children's 
health due to inadequate vaccination rates. One measles outbreak in 
Minnesota last year exceeded the total number of cases in the entire 
U.S. for 2016. The CDC's Immunizations Program is critical to help 
improve our ability to prevent and respond to outbreaks of vaccine 
preventable diseases. The president's fiscal year 2019 budget proposes 
to cut funding for CDC's Immunizations Program by approximately $98 
million. How will the Administration ensure that adults and children 
are receiving the necessary vaccinations to protect them from outbreaks 
of measles and other vaccine-preventable diseases?
    Answer. At this funding level, CDC will continue to provide 
assistance to the 64 immunization awardees for state infrastructure 
awards and vaccine direct assistance. CDC will continue providing 
technical assistance and laboratory support to states and local 
communities responding to vaccine-preventable disease investigations, 
including outbreaks.
                                 ______
                                 
           Questions Submitted by Senator Christopher Murphy
    Question. I know that you have made delivery system reform a 
priority since coming back to HHS. You have laid out several times four 
broad shifts in policy that you think will accelerate the move toward a 
system that rewards value.
    Among those, you have said that the Federal Government needs to use 
Medicare to drive innovation faster as we move from volume to value-
based reimbursements. A natural way to do this would be to use the 
Center for Medicare and Medicaid Innovation (CMMI), which is tasked 
with the development and testing of innovative healthcare payment and 
service delivery models. Just last week, President Trump announced a 
rescission package that included an $800 million cut to the Innovation 
Center. This is despite the fact that the Congressional Budget Office 
has said that on average, the Innovation Center produces an almost four 
to one return in reduced Federal Medicare costs over a 10-year period.
    Do you support this proposed cut to CMMI?
    Answer. Given the long-term fiscal constraints facing our Nation, 
the President is committed to using all available tools to put our 
fiscal house back in order. As the first of several proposed 
rescissions packages, this Administration is fully committed to 
protecting taxpayers, and urges Congress to do the same.
    For CMMI, the rescission of $800 million is in excess of the funds 
needed by the Innovation Center in fiscal years 2018 and 2019. In 
fiscal year 2020, CMMI will receive a new mandatory appropriation of 
$10 billion.
    Question. Will this proposal hinder your ability to drive delivery 
system reform? Is there a statutory reason why this funding cannot be 
rolled over into the future?
    Answer. No, it will not. Under the Affordable Care Act, Congress 
appropriated $10 billion for fiscal years 2011 through 2019 for 
activities initiated under the Innovation Center's statutory authority, 
including for the Innovation Center to test new payment and service 
delivery models. The law appropriates an additional $10 billion for 
each subsequent decade.
    The Innovation Center was created to test innovative payment and 
service delivery models to reduce program expenditures under Medicare, 
Medicaid, and CHIP while preserving or enhancing quality of care.
    The initial years were focused on establishing and operationalizing 
the Innovation Center. With a few exceptions, most of the models the 
Innovation Center has tested or is currently testing launched after 
2015.
    For CMMI, the rescission of $800 million is in excess of the funds 
needed by the Innovation Center in fiscal years 2018 and 2019.
    Question. As you may know, around two-thirds of veteran suicides 
involve a firearm. The Veteran's Administration (VA) has funded 
research studies to determine the factors associated with Veteran 
suicide, including access to lethal means. VA researchers have looked 
at interventions to delay or reduce access to guns for individuals at 
risk of suicide. This research has led the VA to design and implement 
programs that effectively mitigate suicide risk in this population that 
include lethal means reduction. In the general population, more than 
half of suicides involve a firearm. Does the current funding landscape 
allow for research on lethal means reduction in high-risk groups and/or 
the general population?
    Answer. CDC works to prevent injuries and violence through a host 
of programs spanning surveillance, development and evaluation of 
recommendations, and implementation of effective strategies. CDC 
currently conducts and funds research on a variety of related topics, 
including youth violence, child maltreatment, domestic violence and 
sexual violence. These are the topical line items that are supported 
through CDC's annual appropriation for both research and non-research 
activities.
    CDC has, and continues, to support data collection (public health 
surveillance) activities to document the public health burden of 
suicide and firearm injuries and death in the U.S. Understanding the 
patterns, characteristics, and impact of firearm violence is an 
important step toward preventing firearm injuries and deaths in the 
United States.
    In addition, NIH is committed to understanding effective public 
health interventions to prevent suicide. Studies of lethal means 
restriction (i.e., limiting access to lethal methods used for suicide), 
including but not limited to access to firearms, are an important part 
of these efforts. More generally, NIH-supported research on the causes 
and prevention of firearm violence addresses a range of topics, such as 
understanding environmental and sociocultural risks for firearm 
violence; means restriction for people who are at-risk for suicide; and 
pediatrician counseling for parents on safety practices, including safe 
firearm storage.
    Suicide is the 10th leading cause of death in the United States, 
and in 2016, firearms accounted for more than half of all suicide 
deaths.\9\ To address this public health concern, the National 
Institute of Mental Health (NIMH) supports a diverse portfolio of 
suicide prevention research, including efforts to investigate means 
restriction for individuals who are at high risk for suicide. For 
example, one study examined emergency department means restriction 
counseling discharge practices for at-risk patients.\10,11\ This study 
incorporated input from hospital decision makers, leaders of law 
enforcement organizations, gun retailers, and shooting 
ranges.\12,13,14\ This project identified practical and temporary safe 
storage options for families with a member who is at high risk for 
suicide, laying the groundwork for the development of community-based 
firearm safety efforts.\15\ Currently, NIMH funds research that aims to 
develop and test a patient-centered, web-based firearm lethal means 
decision aid to augment clinician-delivered counseling by enabling at-
risk individuals and their families to determine how best to reduce 
home firearm access (e.g., through locking devices or temporary out-of-
home storage). This approach offers the potential to significantly 
enhance current care, reduce access to lethal means of suicide, and 
ultimately reduce suicides by firearm.\16\ Another NIMH-funded study is 
focused on preventing suicide in children and adolescents by enhancing 
the implementation of Safety Check, an evidence-based firearm means 
restriction intervention, in pediatric primary care across 13 
healthcare systems. Successful implementation strategies from this 
study may inform large-scale interventions to prevent suicides by 
firearm.\17\ In addition, NIMH supports a data linkage study to 
identify precursors of firearms injury and suicide among veterans, with 
the aim of reducing fatal and nonfatal traumatic injuries among 
veterans.\18\ Suicide prevention research is a high priority for NIMH, 
and near-term investments in suicide reduction strategies have great 
potential for long-term impact.
---------------------------------------------------------------------------
    \9\ https://webappa.cdc.gov/sasweb/ncipc/leadcause.html.
    \10\ https://projectreporter.nih.gov/
project_info_description.cfm?aid=8976244&icde=22718749.
    \11\ https://www.ncbi.nlm.nih.gov/pubmed/29248278.
    \12\ https://www.ncbi.nlm.nih.gov/pubmed/29704978.
    \13\ https://www.ncbi.nlm.nih.gov/pubmed/29436398.
    \14\ https://www.ncbi.nlm.nih.gov/pubmed/28933926.
    \15\ https://www.ncbi.nlm.nih.gov/pubmed/27842186.
    \16\ https://projectreporter.nih.gov/
project_info_description.cfm?aid=9513052&icde=37016442.
    \17\ https://projectreporter.nih.gov/
project_info_description.cfm?aid=9276816&icde=39675968.
    \18\ https://projectreporter.nih.gov/
project_info_description.cfm?aid=9321294&icde=38281695.
---------------------------------------------------------------------------
                                 ______
                                 
             Question Submitted by Senator Joe Manchin, III
                              jessie's law
    Question. In 2016, we lost a young woman with great potential named 
Jessica Grubb. Jessie was a great student, a loving daughter and 
sister, and an avid runner. She was also recovering from an opioid 
addiction.
    When she had surgery for an infection related to a running injury, 
both Jessie and her parents told her doctors and hospital personnel 
that she was a recovering addict and not to be prescribed opioids. 
Unfortunately, Jessie's discharging physician did not know that she was 
a recovering addict and sent her home with a prescription for 50 
oxycodone pills. That night, she overdosed and passed away in her 
sleep.
    That is why I introduced Jessie's Law to require HHS to establish 
standards for hospitals and medical professionals for prominently 
displaying substance use disorder history--just like any deadly 
allergy--in a person's medical record when that information is provided 
by the patient.
    This language was included in the fiscal year 2018 Omnibus.
    Secretary Azar, will you commit to me that your agency will 
immediately begin working on these standards and disseminate them as 
quickly as possible to medical professionals all over the country? This 
is just a commonsense step that will ensure that hospitals and medical 
professionals have access to the information that they need to provide 
medically appropriate care and keep us from losing more people like we 
lost Jessie Grubb.
    Answer. Yes, efforts are actively underway to ensure that substance 
use disorder data are more readily available to healthcare providers 
and practitioners. The Department is examining ways in which to better 
align 42 CFR Part 2 with HIPAA, in order to ensure that the sharing of 
information on SUDs is more comparable to other chronic diseases.
                                 ______
                                 
            Questions Submitted by Senator Patrick J. Leahy
                     patent system and drug prices
    Question. Brand drugs now account for more than three out of every 
four dollars spent on prescription drugs. The administration's 
blueprint to lower prescription drug costs notes that greater 
competition lowers prices, which in turn benefits patients. 
Unfortunately, abuse of the patent system is delaying patient access to 
new, more affordable, FDA-approved medicines. Examples of this practice 
include Humira, Restasis, and Revlimid and patent abuse are becoming an 
increasingly common practice.
    The fiscal year 2019 Budget and the American Patients First 
blueprint does not address, in any form, the increasing use of our 
patent system to extend monopolies and keep drug prices high for 
patients.
    How does the administration intend to identify and tackle clear 
abuses of the patent system to make sure that generics and biosimilars 
are able to enter the market according to the timeline Congress 
intended?
    Answer. In 2017, FDA Commissioner Gottlieb established the Drug 
Competition Action Plan. Through this plan, FDA is working to help 
ensure consumers can get the medicines they need at affordable prices, 
including by helping ensure access to safe and effective generic drugs. 
One of the three major components of the plan is reducing the so-called 
``gaming'' that frustrates and delays generic drug approvals and 
extends brand monopolies beyond what Congress intended with the Hatch-
Waxman Amendments of 1984.
    FDA has made significant progress in advancing the goals of the 
plan. For example, in July 2017, the Agency held a public meeting on 
``Administering the Hatch-Waxman Amendments'' to gain input on how FDA 
can ensure an optimal balance between encouraging innovation in drug 
development and accelerating the availability to the public of lower-
cost alternatives to brand name drugs. One of the specific issues FDA 
solicited input on was how the balance struck in the Hatch-Waxman 
Amendments has been affected by practices and trends related to 
patents. This was a well-attended and successful meeting, and over 90 
substantive comments were submitted to the public docket. The Agency is 
currently assessing these comments as it continues to actively identify 
new initiatives that can enhance efforts to provide more safe, 
effective, and high-quality generic medicines to the public, and 
address ``gaming,'' including abuses of the patent system, that 
exploits rules and loopholes in our system to delay generic approval 
and thereby extend a drug's monopoly beyond what Congress intended.
    The fiscal year 2019 Budget proposal also includes an important 
legislative fix to address gaming related to the Hatch-Waxman 
Amendments. As background, in the Hatch-Waxman Amendments, Congress 
provided a period of 180-day exclusivity for certain first generic 
applications as an incentive for generic manufacturers to challenge 
patents on innovator drugs that might otherwise prevent approval or 
delay generic entry into the market. This exclusivity, which is 
generally designed to reward certain generic drug sponsors with a 
finite period of marketing exclusivity, was intended to encourage 
generic drug development that might not have been undertaken otherwise. 
In some cases, however, the legal framework surrounding this 
exclusivity has delayed generic competition to an extent that was not 
intended by the Hatch-Waxman Amendments, and in ways that do not serve 
the public health. The fiscal year 2019 President's FDA Budget proposal 
would address some of these issues by enhancing generic competition in 
areas where 180-day exclusivity is blocking such competition for 
extensive periods of time in certain circumstances, including 
situations where first generic applicants may be deliberately parking 
their 180-day exclusivity to delay approval of subsequent generic 
applicants who have also challenged the patents on the innovator 
product.
    FDA also prioritizes its work to facilitate greater availability of 
biosimilar and interchangeable products. Increased access to these 
products should lead to greater price competition in the biological 
product marketplace and help bring down the costs of these important 
products. Although FDA has approved 10 marketing applications for 
biosimilars as of May 25, 2018, we are aware that many of these 
approved biosimilars have not yet been marketed. Although the 
challenges faced by the manufacturers in marketing of these products 
may be outside the Agency's control, FDA remains focused on creating 
and maintaining a rigorous, modern, and efficient review program for 
biosimilar and interchangeable products.
    Building on the success of the Drug Competition Action Plan, 
described above, FDA will soon be launching a comprehensive Biosimilars 
Action Plan that will outline a number of policies and actions the 
Agency intends to put forward to enhance the efficiency of FDA's review 
of marketing applications for biosimilar and interchangeable products; 
to increase regulatory certainty for biosimilar manufacturers and other 
stakeholders; to educate stakeholders about biosimilar and 
interchangeable products; and to reduce gaming of FDA regulations or 
other attempts to unfairly delay market competition.
                        lower drug costs abroad
    Question. It is well-documented that brand-name prescription drug 
prices in the United States exceed the costs for the same brand drug in 
other countries. For the top-selling brand drugs in the United States, 
the costs are two-to-three times the price of the same drug overseas. 
In the administration's blueprint on drug prices, HHS proposes to work 
in conjunction with the Department of Commerce and USTR to ``address 
the unfair disparity between drug prices in America and other developed 
countries'' through ``appropriate regulatory changes and seeking 
legislative solutions.''
    Is there any evidence of a pharmaceutical company lowering the 
price of a brand drug in the U.S. because of a price increase in 
another country?
    Answer. U.S. consumers and taxpayers generally pay more for brand 
drugs than do consumers and taxpayers in other OECD countries. In 
effect, other countries are not paying an appropriate share of the 
necessary research and development to bring innovative drugs to the 
market and are instead freeriding off of U.S. consumers and taxpayers. 
As part of President Trump's blueprint on drug prices, ``American 
Patients First,'' HHS is actively reviewing what can be done to reduce 
the pricing disparity and spread the burden for incentivizing new drug 
development more equally between the U.S. and other developed 
countries.
    Question. What policies, if any, are the administration considering 
that would compel pharmaceutical companies to lower drug prices in the 
United States as a result of our trade agreements?
    Answer. As part of President Trump's blueprint on drug prices, 
``American Patients First,'' HHS is actively reviewing what can be done 
to reduce the pricing disparity and spread the burden for incentivizing 
new drug development more equally between the U.S. and other developed 
countries.
                           family separation
    Question. The Department of Homeland Security (DHS) recently 
announced that it will implement a ``zero tolerance'' policy and refer 
100 percent of adults illegally crossing the border for criminal 
prosecution--even if they arrive with children. This will establish a 
de facto family separation policy, forcibly breaking up families and 
sending children into the custody of your agency. DHS has thus far 
refused to make public its memo outlining this new ``zero tolerance'' 
policy.
    Given your agency's formal role in housing and caring for children 
separated from their families at the border, has your agency issued any 
memoranda or guidance to accompany DHS' ``zero tolerance'' policy memo? 
If so, can you please provide all such documents to this Committee?
    Answer. ORR continues to implement the Unaccompanied Alien Children 
(UAC) Program in compliance with Federal law and the Flores settlement 
agreement, and to provide care to all UAC in its custody. ORR has not 
issued any guidance because additional guidance is not necessary.
    Question. Have you estimated how many additional children will end 
up in the care of the Office of Refugee Resettlement (ORR) as a result 
of the Trump administration's new ``zero tolerance'' policy?
    Answer. HHS is working closely with our DHS partners to anticipate 
and plan for the potential number of unaccompanied alien children (UAC) 
referrals and their length of stay in our care. Historically, the 
timing and number of UAC referred to HHS each year for care and custody 
has been difficult to predict with any certainty and the Department 
assesses need for capacity growth or decline on an ongoing basis.
    Question. Have you estimated the increased cost associated with 
this influx of children?
    Answer. We are working closely with our DHS partners to understand 
the potential impacts on the UAC program, including number of 
referrals, length of stay in our care, capacity needs, and cost 
estimates. As always, this program is very unpredictable and we will 
continue to work with Congress as we learn more.
    Question. Will you submit an updated budget request for ORR to 
reflect these costs?
    Answer. HHS is closely monitoring its shelter capacity needs in 
coordination with our interagency partners, evaluating its resource 
needs and, if necessary, will seek to maximize currently available 
resources and authorities. As always, we will continue to work with 
Congress as we learn more.
    Question. Please provide the average duration in ORR for 
unaccompanied children on a monthly basis for fiscal year 2014 through 
fiscal year 2018 (to date).
    Answer: [The information follows:]

------------------------------------------------------------------------
                                                                 Average
                       Fiscal Year 2014                          Length
                                                                 of Stay
------------------------------------------------------------------------
Oct...........................................................       40
Nov...........................................................       37
Dec...........................................................       33
Jan...........................................................       40
Feb...........................................................       35
March.........................................................       26
April.........................................................       24
May...........................................................       21
June..........................................................       16
July..........................................................       19
Aug...........................................................       25
Sept..........................................................       29
------------------------------------------------------------------------


------------------------------------------------------------------------
                                                                 Average
                       Fiscal Year 2015                          Length
                                                                 of Stay
------------------------------------------------------------------------
Oct...........................................................       31
Nov...........................................................       30
Dec...........................................................       30
Jan...........................................................       32
Feb...........................................................       34
March.........................................................       32
April.........................................................       29
May...........................................................       31
June..........................................................       31
July..........................................................       32
Aug...........................................................       35
Sept..........................................................       35
------------------------------------------------------------------------


------------------------------------------------------------------------
                                                                 Average
                       Fiscal Year 2016                          Length
                                                                 of Stay
------------------------------------------------------------------------
Oct...........................................................       33
Nov...........................................................       34
Dec...........................................................       32
Jan...........................................................       32
Feb...........................................................       35
March.........................................................       35
April.........................................................       33
May...........................................................       32
June..........................................................       35
July..........................................................       38
Aug...........................................................       39
Sept..........................................................       38
------------------------------------------------------------------------


------------------------------------------------------------------------
                                                                 Average
                       Fiscal Year 2017                          Length
                                                                 of Stay
------------------------------------------------------------------------
Oct...........................................................       34
Nov...........................................................       34
Dec...........................................................       34
Jan...........................................................       38
Feb...........................................................       43
March.........................................................       57
April.........................................................       77
May...........................................................       74
June..........................................................       61
July..........................................................       42
Aug...........................................................       35
Sept..........................................................       40
------------------------------------------------------------------------


------------------------------------------------------------------------
                                                                 Average
                       Fiscal Year 2018                          Length
                                                                 of Stay
------------------------------------------------------------------------
Oct...........................................................       42
Nov...........................................................       44
Dec...........................................................       44
Jan...........................................................       50
Feb...........................................................       56
March.........................................................       56
April.........................................................       52
------------------------------------------------------------------------


    Question. Reports confirm that your agency is inspecting four 
military instillations for their suitability to shelter unaccompanied 
minors and children separated from their families at the border. The 
Obama administration resorted to temporarily sheltering children in 
military installations after an unexpected surge in border crossings by 
unaccompanied minors. However, your agency is proactively searching for 
more space to house children. These inspections comes just weeks after 
the Trump administration announced a new ``zero tolerance'' prosecution 
policy that will separate potentially thousands of additional children 
from their families and send them into your agency's care. How many 
additional children is your agency expecting to shelter in these 
military installations as a result of the Trump administration's new 
``zero tolerance'' prosecution policy?
    Answer. HHS is closely working with our DHS partners to anticipate 
and plan for the potential number of unaccompanied alien children (UAC) 
referrals and their length of stay in our care.ORR uses influx care 
facilities only until space in a state-licensed care facility is 
available. Prudent planning requires HHS to proactively search for more 
space to house UAC during an influx situation. Similar to recent years, 
HHS is considering whether military facilities are a viable option for 
use as influx care facilities. No final decisions have been made at 
this time and HHS continues to evaluate the situation on an ongoing 
basis. As always, this program is very unpredictable and we will 
continue to work with Congress as we learn more.
    Question. Will these military installations be subject to the same 
regulations and standards applying to HHS facilities currently 
sheltering unaccompanied minors and children separated from their 
families at the border?
    Answer. HHS has policies in place for all influx care facilities 
that are in compliance with the Flores agreement. These policies are 
found in Section 1.7 of the ORR Guide: Children Entering the United 
States Unaccompanied. In the event a military base is used to house 
UACs, the policies in Section 1.7 would apply.
    Question. Will uniformed and armed military personnel be assigned 
duties that require them to interact with children sheltered at these 
military installations?
    Answer. No. HHS remains responsible for the care, supervision, and 
services for all UAC in HHS custody. Consistent with past practice, HHS 
only occupies unused portions of DoD installations.
                          refugee resettlement
    Question. For fiscal year 2018, the Trump administration 
established a refugee admissions level of 45,000--a historic low 
particularly when considering the scale of the global humanitarian 
crisis we face. But even more troubling, as of May--more than midway 
through the current fiscal year--only 12,000 or so refugees have been 
resettled. At this pace, the administration will not even resettle half 
of the 45,000 refugees it has committed to admitting this fiscal year.
    What are the Office of Refugee Resettlement's projections for the 
number of refugees it expects to serve and resettle for the remainder 
of fiscal year 2018?
    Answer. ORR does not have a role in the admission of refugees and 
is therefore not in the best position to estimate the number of 
refugees that will arrive. ORR will continue to provide services to all 
refugees who apply and meet eligibility requirements.
               low income home energy assistance program
    Question. In January of this year, 44 Senators and I wrote to the 
President in support of including funding for the Low Income Home 
Energy Assistance Program (LIHEAP) in the President's fiscal year 2019 
Budget. Unfortunately, the Administration chose to again eliminate this 
lifesaving program. In a response to our letter, Office of Management 
and Budget (OMB) Director Mulvaney cited a GAO report from 2010, which 
observed patterns of fraud and abuse in the program as one of the 
justifications for eliminating funding. OMB Director Mulvaney's letter 
contends that taxpayer dollars need to be spent efficiently and in an 
accountable manner and that LIHEAP is susceptible to fraud and abuse. 
GAO's 2010 report makes six recommendations which, according to GAO, 
were all implemented even before the report was released.
    If HHS has indeed implemented all of GAO's recommendations, as GAO 
has noted, what new examples can you provide regarding whether the 
program still susceptible to fraud and abuse, and how so?
    Answer. The program's susceptibility to fraud and abuse is only one 
of the reasons for not funding LIHEAP. LIHEAP is not the only program 
helping low-income households pay their heating and cooling bills. 
State and local governments provide significant funding assistance, and 
the majority of states prohibit utilities from discontinuing a 
household's energy in periods of severe weather.
    Question. Families in Vermont often have to make impossible choices 
between putting food on the table, medical care or home heating. Do you 
believe assisting low income families with heating costs is a worthy 
objective?
    Answer. LIHEAP is not the only program helping low-income 
households pay their heating and cooling bills. State and local 
governments provide significant funding assistance, and the majority of 
states prohibit utilities from discontinuing a household's energy in 
periods of severe weather.
    Question. Do you support elimination of the LIHEAP Program? If so, 
why?
    Answer. The HHS Budget reflects a commitment to exercising fiscal 
stewardship by streamlining government services and making the best 
possible use of taxpayer dollars. We are proposing the elimination of 
this program to prioritize funding for other human services activities. 
LIHEAP is not the only program helping low-income households pay their 
heating and cooling bills.

                          SUBCOMMITTEE RECESS

    Senator Blunt. The subcommittee will stand in recess.
    [Whereupon, at 12:04 p.m., Thursday, May 10, the 
subcommittee was recessed, to reconvene subject to the call of 
the Chair.]