[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
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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.
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\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.
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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.
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______
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.]