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




 
  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2020

                              ----------                              


                        THURSDAY, APRIL 4, 2019

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 10:05 a.m. in room SD-124, Dirksen 
Senate Office Building, Hon. Roy Blunt (chairman) presiding.
    Present: Senators Blunt, Alexander, Moran, Capito, Kennedy, 
Hyde-Smith, Rubio, Murray, Durbin, Shaheen, Merkley, Schatz, 
Baldwin, Murphy, and Manchin.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                        Office of the Secretary

STATEMENT OF HON. ALEX AZAR, SECRETARY


                 opening statement of senator roy blunt


    Senator Blunt. The Appropriations Subcommittee on Labor, 
Health and Human Services, Education, and Related Agencies will 
come to order.
    Secretary Azar, thank you for being here this morning and 
for our efforts to work together. While they could always be 
better, I think we are about to get you staffed up to a point 
that will no longer be the excuse. So we will think of what 
comes as the next reason that this is not working the way it 
should. But I wanted to encourage you to continue to do that.
    Obviously, this is a difficult budget for us to talk about, 
and frankly, I think it is a difficult budget for you to 
defend. And we will see what we have to do here.
    The Budget Control Act has impact on this. In the case of 
the budget that you have been asked to submit, there is a 
reduction of 14 percent. The Budget Control Act would require 
an overall reduction in the non-defense discretionary spending 
of 9 percent. So this budget exceeds even that.
    I would say for the 9 percent, as I mentioned last week 
with the Education Secretary, President Trump did not sign the 
Budget Control Act. President Obama did. And you did not vote 
for it, and most of us who were here when we did the Budget 
Control Act did. So there is some shared responsibility where 
that decision has led us. But there will be a number of 
concerns that I imagine you have to share about what this 
budget asks for.
    We made a top priority, in the years I have been Chairman 
of this committee, to ensure that medical research has the 
resources it needs at this particular time of real breakthrough 
potential to do what it does in a way that saves lives, 
improves lives, and frankly benefits taxpayers as we find more 
solutions. As an example, if we could find a way to identify 
Alzheimer's and delay onset by 5 years, we would cut the 
projected cost for Alzheimer's by a third between now and 2050. 
The cuts that you are proposing for NIH would be an overall cut 
of 12.6 percent in research, or almost $5 billion. I am sure 
that this is not going to happen. But for that not to happen, 
we have to have a number to work with that you did not have to 
work with yet. And I believe we will have that number.
    You know, we are not going to eliminate LIHEAP (Low Income 
Home Energy Assistance Program) funding that provides 6 million 
households with heating and cooling assistance. This budget 
cuts resources to train a lot of people for medical professions 
and behavioral health and pediatric dentistry. And we are not 
likely to do any of those things.
    I understand you had to make difficult decisions here.
    I do appreciate the two new initiatives that you proposed, 
I will be supportive, and I believe the committee will be 
supportive of those. One, to eliminate the transmission of HIV 
in the United States by 2030. Phase one of the 10-year plan 
would infuse the hardest hit States and communities--Missouri 
is one of those--with additional resources, additional 
expertise, additional diagnostic, and treatment options. And I 
am pleased to see the new pediatric cancer program to provide 
$50 million a year over the next decade to launch a major data 
project on childhood cancer. Now, that runs pretty dramatically 
in the face of cutting overall NIH funding. But I do think it 
gives us the opportunity to look even closer at pediatric 
cancer and factor that in as we continue to, hopefully, improve 
NIH funding.
    In addition to these new programs, I believe that mental 
health treatment needs to be treated as any other health issue. 
And the budget request includes level funding for the certified 
community behavioral health clinics. Missouri is one of the 
eight pilot States treating behavioral health like all other 
health, and we need to do more to encourage that. The head of 
Barnes-Jewish Hospital told me just last week--he said, ``I 
cannot treat a person's diabetes until their schizophrenia is 
under control.'' And I believe we are going to find that if you 
do treat behavioral health like all other health, you actually 
save more money on the other healthcare costs than you spend 
doing the right thing in behavioral health.
    Finally, the administration's commitment to ending the 
opioid epidemic is well reflected in this request. According to 
the Council of Economic Advisors, the total economic cost of 
the opioid epidemic in 2017 was $684.6 billion. The cost to our 
economy, the cost to families of the opioid epidemic was that. 
According to the Missouri Hospital Association, this estimate 
suggests the epidemic costs the U.S. nearly $1.6 billion every 
day, $21,700 every second of every day through 2017. Over the 
past 4 years, this subcommittee has increased funding to combat 
the epidemic by more than $3.5 billion, and we have had great 
bipartisan leadership on both sides of where I am sitting who 
understand how this has impacted their States and have 
forcefully made that case.
    Mr. Secretary, I appreciate what you had to do to try to 
prioritize limited resources. We will try to do things that 
make those resources more realistic. I am glad you are here 
today and glad you bring all the expertise and ability you 
bring personally to this job.
    [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 2020 budget request. We look forward to your 
testimony.
    The Department's budget request is $77.6 billion, a reduction of 
$12.8 billion or 14 percent. I understand that the President's budget 
request adhered to the Budget Control Act. However, most of the 
proposed reductions are simply not realistic.
    My number one priority as Chairman is to ensure our medical 
research community has the resources necessary to continue to make 
breakthroughs that will save countless lives, improve the health of all 
Americans, and ultimately save our Federal Government billions of 
dollars in healthcare costs. For example, if budget cuts were applied, 
Alzheimer's research would by cut by $326 million.
    Further, this Subcommittee is not going to eliminate LIHEAP 
(pronounced lie-heap) which provides 6 million households with heating 
and cooling assistance; cut resources to train tens of thousands of 
medical professionals in behavioral health and pediatric dentistry; or 
diminish our investments to States for critical public health issues 
such as heart disease, strokes, and diabetes.
    I understand you had to make difficult decisions under a tight 
budget. While there are many funding reductions I fundamentally 
disagree with, there are two new initiatives you have proposed that I 
think we should seriously consider this year.
    First, there is a proposal to eliminate the transmission of HIV in 
the United States by 2030. Phase one of the 10 year plan would infuse 
the hardest-hit States and communities, Missouri being one, with 
additional resources, expertise, and diagnostic and treatment options.
    Second, there is a new pediatric cancer program to provide $500 
million over the next decade to launch a major data project on 
childhood cancer. While researchers have made remarkable gains in 
improving the survival rate for childhood leukemia, survival rates for 
some pediatric cancer types have not increased.
    In addition to these new programs, as someone who believes mental 
health should be treated like all other health concerns, I am pleased 
that the budget request includes level funding for Certified Community 
Behavioral Health Clinics. In Missouri, this renewed focus for mental 
health has made a significant difference in reducing wait times and 
getting people the help they need. However, CCBHCs are not the only 
answer to treating mental and behavioral health issues and the budget 
cuts other important programs focused on integrating mental healthcare 
into primary care settings. As the head of Barnes-Jewish hospital told 
me just last week, ``I can't treat a person's diabetes until their 
schizophrenia is under control.'' Mental health is fundamental to a 
person's overall well-being and we must recognize and treat it that 
way.
    Finally, the Administration's commitment to ending the opioid 
epidemic is well reflected in the request. According to the Council of 
Economic Advisors, the total economic cost of the opioid epidemic in 
2017 was $684.6 billion. According to the Missouri Hospital 
Association, this estimate suggests the epidemic costs the U.S. nearly 
$1.9 billion every day, or $21,700 every second of every day during 
2017. Over the past 4 years, the LHHS Subcommittee has increased 
funding to combat the epidemic by more than $3.5 billion. I am 
committed to continuing to ensure there is adequate funding and 
flexibility for States and communities to respond.
    While I appreciate the Department prioritizing limited resources, 
this hearing is an opportunity for us to fully understand whether you 
made many of these cuts because you believe these programs are 
ineffective and not necessary or because your topline budget level 
forced you to do so.
    Mr. Secretary, I look forward to hearing your testimony today and 
appreciate your dialogue with us about these important issues. Thank 
you.

    Senator Blunt. And I would like to turn to my partner here 
in this effort, Senator Murray.

                   STATEMENT OF SENATOR PATTY MURRAY

    Senator Murray. Well, thank you very much, Chairman Blunt.
    Welcome, Secretary Azar.
    People across the country made pretty clear last November 
that they want us to fight for their healthcare and make sure 
families get the care they need. That means fighting for 
protections that allow people with preexisting conditions to 
get quality, affordable health coverage. It means fighting to 
bring down the skyrocketing healthcare costs. It means fighting 
for public health investments that keep our communities safe 
and address crises like the HIV and opioid epidemics. And it 
means fighting for investments in research that can help 
discover new treatments, save lives.
    But instead of fighting to defend people's healthcare, 
President Trump is fighting in court to take healthcare away 
from millions of people who are covered through the exchanges, 
covered through Medicaid, and are covered by their parents' 
plan. Instead of fighting to bring those costs down and help 
people get the care they need, he is fighting in court against 
protections for over 130 million people with preexisting 
conditions; for bringing back annual and lifetime caps on 
benefits, even for people who get their insurance through their 
own job; and for letting insurance companies offer plans that 
do not cover essential services like maternity care or 
prescription drugs.
    And President Trump's budget before us is cut from that 
same cloth. It bulldozes right over the concerns of families 
with proposals that would make it harder for people to get care 
and cuts that would undermine the well-being of families across 
the nation.
    Overall, this budget proposes a deep $12.7 billion cut to 
the Department of Health and Human Services, slashing it by 14 
percent. I always say a budget is a reflection of your values. 
Well, like many of his actions, this budget tells a very 
different story about President Trump's healthcare priorities 
than his empty promises. Despite claiming time and time again 
he would fight for people's healthcare and despite his recent 
claim Republicans would be the party of healthcare, President 
Trump is continuing to push for harmful policies that would 
weaken patient protections, take coverage away from people, and 
put needed healthcare further out of reach.
    This budget includes Trump Care, which the Congressional 
Budget Office estimates would kick tens of millions of people 
off their health insurance. When it comes to curbing the HIV 
and opioid epidemics, President Trump promised to fight the 
fire, but his budget actually fans the flames. It would make 
these crises far worse by cutting over $1 trillion from 
Medicaid over the next decade and repealing Medicaid expansion. 
Medicaid is the largest source of insurance coverage for people 
with HIV, covering more than 40 percent of people with HIV and 
care. And the 37 States that expanded Medicaid show how it can 
play an important role in addressing the opioid crisis as well. 
In some of these States, as many as four out of five people 
receiving treatment for opioid addiction are insured by 
Medicaid.
    The Centers for Disease Control and Prevention also plays a 
very important role addressing these public health crises and 
many others. Yet, the Trump administration proposes cutting its 
budget by a tenth. This proposes cutting immunization efforts 
by $78 million, even amid an alarming measles outbreak in my 
home State and several others. It proposes cutting work on 
birth defects and disabilities by $44 million and proposes 
cutting efforts to combat antibiotic-resistant pathogens and 
emerging infectious diseases by $103 million despite the World 
Health Organization labeling AMR, ``one of the biggest threats 
to global health.''
    And when it comes to medical research, this budget is a 
small step forward and a marathon sprint back. I do applaud the 
administration's call for more pediatric cancer research. For 
every new penny President Trump proposes for pediatric cancer 
research, however, he proposes cutting a dollar from the 
National Institutes of Health. Cutting medical research by 13 
percent, as he proposed, would slow our efforts to advance our 
understanding of Alzheimer's disease, develop vaccines for HIV 
and flu, and treatments and cures for every other kind of 
cancer.
    And at a time when our Nation is facing a health 
professional shortage, it is proposing to cut almost $800 
million from healthcare workforce training programs that 
support tuition assistance, loan forgiveness, and training for 
several hundred thousand health professionals annually.
    This budget also continues the Trump-Pence administration's 
harmful trend of putting ideology over women's health and 
reproductive freedoms. Its language specifically excluding 
Planned Parenthood from Federal funding is just one of the many 
alarming steps backwards for women's healthcare from this 
administration.
    Another is the recent announcement stripping Title X family 
planning funds from several qualified Planned Parenthood 
affiliates, despite their proven record helping millions of 
people struggling to make ends meet, get birth control, cancer 
screenings, and other basic health services.
    Another example is the administration's gag rule, which 
will push Planned Parenthood out of the program altogether, 
interfere with patients' ability to learn about their full 
range of reproductive care options and prevent people from 
across the country from getting the care they need with the 
providers that they trust.
    Once again, the Trump administration proposes eliminating 
safety net programs that provide critical assistance to 
millions of vulnerable families, like the Low-Income Home 
Energy Assistance Program, which helps families afford heating 
and cooling, and the Community Services Block Grant, which 
gives States resources to address the challenge of poverty, and 
eliminating funding for preschool development grants, which 
provide high-quality preschool to tens of thousands of 
families. It is clear that we are facing a childcare crisis in 
this country. Parents struggle every day to find and pay for 
high-quality programs. We need more investments in that, not 
cuts in early childhood education.
    And this budget continues to show disregard for families 
fleeing violence and extreme poverty in Central America. This 
budget proposes a gimmicky $2 billion contingency fund on the 
mandatory side for the unaccompanied children program, in 
addition to the base discretionary appropriation. Let me be 
clear. I want to make sure that every child in HHS custody is 
well cared for, but I have been deeply disappointed in 
President Trump's treatment of migrant children, from 
heartlessly separating children from their parents to 
attempting to undermine protections for migrant children. And I 
have been frustrated with your Department for failing to sound 
the alarm on the lasting damage that family separation would 
cause, sharing information with the Department of Homeland 
Security so they can target potential sponsors for deportation, 
and relying heavily on unlicensed temporary facilities which 
are three times as expensive as permanent beds in licensed 
centers, to say nothing of my concern that the Office of 
Refugee Resettlement was tracking young women's reproductive 
health and that former Director Scott Lloyd was personally 
interfering with young women's decisions about their bodies.
    Finally, Mr. Secretary, I am concerned by a recent proposal 
you outlined in a letter to my office to restructure the Office 
of the Assistant Secretary for Health. That restructuring would 
impact programs that serve adolescents, women, low-income 
communities, and more, and I am very concerned that that 
proposal, much like this budget proposal, would serve very 
little purpose beyond prioritizing ideology over the health 
needs of families in this country.
    Mr. Secretary, finally, I just want to note it is 
inaccurate to claim the Budget Control Act requires the 
President to submit his budget at sequestration levels. In 
fact, just 2 years ago, President Trump's budget proposed an 
increase to the caps for defense spending. So I hope you do not 
rely on that excuse for decisions in this budget.
    Thank you very much, Mr. Chairman.
    Senator Blunt. Thank you, Senator Murray.
    So, Secretary, you and I have talked about the--oh, I am 
sorry. I am so eager. I have so many questions I want to ask 
here. Maybe you want to waive your opening statement.
    [Laughter.]
    Senator Blunt. Go ahead with your opening statement.

                  SUMMARY STATEMENT OF HON. ALEX AZAR

    Secretary Azar. Well, thank you very much, Chairman Blunt 
and Ranking Member Murray. Thank you for inviting me to discuss 
the President's budget for fiscal year 2020.
    It is an honor to have spent the year since I last appeared 
before this committee leading the Department of Health and 
Human Services. The men and women of HHS (Department of Health 
and Human Services) have delivered remarkable results during 
that time, including record new and generic drug approvals, new 
affordable health insurance options, and signs that the trend 
in drug overdose deaths is beginning to flatten and decline.
    The budget proposes $87.1 billion in fiscal year 2020 
discretionary spending for HHS while moving toward our vision 
for a healthcare system that puts American patients first. It 
is important to note that HHS had the largest discretionary 
budget of any non-defense department in 2018, which means that 
staying within the caps set by Congress has required difficult 
choices that I am sure many will find quite hard to 
countenance. I know that members of this committee have 
delivered strong investments in HHS' discretionary budget in 
the past, especially at the National Institutes of Health, and 
I want to be clear that HHS appreciates this work over the 
years.
    Today I want to highlight how the President's budget 
supports a number of important goals for HHS.
    First, the budget proposes reforms to help deliver 
Americans' truly patient-centered affordable care. The budget 
would empower States to create personalized healthcare options 
that put you as the American patient in control and ensure you 
are treated like a human being and not like a number. 
Flexibilities in the budget would make this possible while 
promoting fiscal responsibility and maintaining protections for 
people with preexisting conditions.
    Second, the budget strengthens Medicare to help secure our 
promise to America's seniors. The budget extends the solvency 
of the Medicare trust fund for 8 years while the program's 
budget will still grow at a 6.9 percent annual rate. In three 
major ways, the budget lowers cost for seniors and tackles 
special interests that are currently taking advantage of the 
Medicare program.
    First, we propose changes to discourage hospitals from 
acquiring smaller practices just to charge Medicare more.
    Second, we address overpayments to post-acute care 
providers.
    And third, we will take on drug companies that are 
profiting off of seniors and Medicare. Through a historic 
modernization of Medicare Part D, we will lower seniors' out-
of-pocket costs and create incentives for lower list prices. I 
believe there are many areas of common ground on drug pricing 
where we can work together to pass bipartisan legislation to 
help people.
    The efforts we proposed around taking on special interests 
in the Medicare program are so sensible and bipartisan, in 
fact, that even the ``New York Times'' editorial board praised 
these ideas last week.
    We also protect seniors by transferring funding for 
graduate medical education and uncompensated care from Medicare 
to the general Treasury fund so that all taxpayers, not just 
our seniors, share these important costs.
    Finally, the budget fully supports HHS' five point strategy 
for the opioid epidemic: better access to prevention, 
treatment, and recovery services; better targeting the 
availability of overdose-reversing drugs; better data on the 
epidemic; better research on pain and addiction; and better 
pain management practices. The budget builds on appropriations 
made by this committee and provides $4.8 billion towards these 
efforts, including the $1 billion State Opioid Response 
Program, which we have focused on access to medication-assisted 
treatment, behavioral support, and recovery services.
    The budget also invests in other public health priorities, 
including fighting infectious disease at home and abroad. It 
proposes $291 million in funding for the first year of 
President Trump's plan to use the effective treatment and 
prevention tools that we have today to end the HIV epidemic in 
America by 2030.
    HHS also remains vigilant on other public health 
challenges, including the current epidemic of teen use of e-
cigarettes. In fact, I am pleased to announce that today the 
FDA (Food and Drug Administration) is issuing warning letters 
to companies for making, selling, or distributing liquids used 
for e-cigarettes that have misleading labeling or advertising 
that resembles prescription cough syrups. The Trump 
administration supports a comprehensive balanced policy 
approach to regulating e-cigarettes, closing the on-ramp for 
kids to become addicted to nicotine, while allowing for the 
promise of an off-ramp for adult smokers of combustible tobacco 
products.
    This year's budget will advance American healthcare and 
help deliver on the promises we made to the American people, 
and I look forward to working with this committee on our shared 
priorities and I look forward to your questions today. Thank 
you very much.
    [The statement follows:]
                  Prepared Statement of Hon. Alex Azar
    The mission of the U.S. Department of Health and Human Services 
(HHS) is to enhance and protect the health and well-being of all 
Americans by providing for effective health and human services and by 
fostering sound, sustained advances in the sciences underlying 
medicine, public health, and social services. This work is organized 
into five strategic goals, and is unified by a vision of our 
healthcare, human services, and public health systems working better 
for the Americans we serve. By undertaking these efforts in 
partnerships with States, territories, Tribal governments, local 
communities, and the private sector, we will succeed at putting 
Americans' health first.
    Since I testified before this committee in 2018, the HHS team has 
delivered impressive results. This past year saw HHS, the Department of 
Labor, and the Department of Treasury open up new affordable health 
coverage options, at the same time the Affordable Care Act (ACA) 
exchanges were stabilized, with the national average benchmark premium 
on HealthCare.gov dropping for the first time ever. According to a 
report by the Council of Economic Advisers, actions taken by the 
Administration, along with the elimination of the individual mandate 
penalty, are estimated to provide a net benefit to Americans of $453 
billion over the next decade.
    Congress worked with the Administration to deliver new resources 
for fighting the opioid crisis, allowing HHS to make more than $2 
billion in opioid-related grants to States, territories, Tribes, and 
local communities in 2018. Prescriptions for medication-assisted 
treatment options and naloxone are up, while legal opioid prescribing 
is down. HHS also worked to bring down prescription drug prices, 
including by setting another record for most generic drug approvals by 
FDA in a fiscal year and working with Congress to ensure pharmacists 
can inform Americans about the lowest-cost prescription drug options.
    The President's Fiscal Year 2020 Budget supports HHS's continued 
work on these important goals by prioritizing key investments that help 
advance the Administration's commitments to improve American 
healthcare, address the opioid crisis, lower the cost of drugs, and 
streamline Federal programs, while reforming the Department's programs 
to better serve the American people.
    The Budget proposes $87.1 billion in discretionary budget authority 
and $1.2 trillion in mandatory funding for HHS. It reflects HHS's 
commitment to making the Federal Government more efficient and 
effective by focusing spending in areas with the highest impact.
    HHS's Fiscal Year 2020 Budget reflects decisions not just to be 
prudent with taxpayer dollars, but also to stay within the budget caps 
Congress created in the Budget Control Act. With the largest non-
defense discretionary appropriation of any cabinet agency in 2019, HHS 
must make large reductions in spending in order to stay within 
Congress's caps, set a prudent fiscal course, and provide for other 
national priorities. This budget demonstrates that HHS can prioritize 
its important work within these constraints, and proposes measures to 
reform HHS programs while putting Americans' health first.
   reform, strengthen, and modernize the nation's health care system
Reforming the Individual Market for Insurance
    The Budget proposes bold reforms to empower States and consumers to 
improve American healthcare. These reforms return the management of 
healthcare to the States, which are more capable of tailoring programs 
to their unique markets, increasing options for patients and providers, 
and promoting financial stability and responsibility, while protecting 
people with pre-existing conditions and high healthcare costs.
    The Budget includes proposals to make it easier to open and use 
Health Savings Accounts and reform the medical liability system to 
allow providers to focus on patients instead of lawsuits.
Lowering the Cost of Prescription Drugs
    Putting America's health first includes improving access to safe, 
effective, and affordable prescription drugs. The Budget proposes to 
expand the Administration's work to lower prescription drug prices and 
reduce beneficiary out-of-pocket costs. The Administration has proposed 
and, in many cases, made significant strides to implement bold 
regulatory reforms to increase competition, improve negotiation, create 
incentives to lower list prices, reduce out-of- pocket costs, improve 
transparency, and address foreign free-riding. Congress has already 
taken bipartisan action to end pharmacy gag clauses, so patients can 
work with pharmacists to lower their out-of-pocket costs. The Budget 
proposes to:
  --Stop regulatory tactics used by brand manufacturers to impede 
        generic competition;
  --Ensure Federal and State programs get their fair share of rebates, 
        and enact penalties to prevent the growth of prescription drug 
        prices beyond inflation;
  --Improve the Medicare Part D program to lower seniors' out-of-pocket 
        costs, create an out-of-pocket cap for the first time, and end 
        the incentives that reward list price increases;
  --Improve transparency and accuracy of payments under Medicare Part 
        B, including imposing payment penalties to discourage pay-for-
        delay agreements; and
  --Build on America's successful generic market with a robust 
        biosimilars agenda, by improving the efficient approval of safe 
        and effective biosimilars, ending anti- competitive practices 
        that delay or restrict biosimilar market entry, and harnessing 
        payment and cost-sharing incentives to increase biosimilar 
        adoption.
Reforming Medicare and Medicaid
    Medicare and Medicaid represent important promises made to older 
and vulnerable Americans, promises that President Trump and his 
administration take seriously. The Budget supports reforms to make 
these programs work better for the people they serve and deliver better 
value for the investments we make. This includes a plan to modernize 
Medicare Part D to lower drug costs for the Medicare program and for 
Medicare beneficiaries, as well as proposals to drive Medicare toward a 
value-based payment system that puts patients in control. The Budget 
also provides additional flexibility to States for their Medicaid 
program, putting Medicaid on a path to fiscal stability by 
restructuring its financing, reducing waste, and focusing the program 
on the low-income populations Medicaid was originally intended to 
serve: the elderly, people with disabilities, children, and pregnant 
women.
Paying for Value
    The Administration is focused on ensuring Federal health programs 
produce better care at the lowest possible cost for the American 
people. We believe that consumers, working with providers, are in the 
best position to determine value. The Budget supports an expansion of 
value-based payments in Medicare with this strategy in mind. That 
expansion, along with implementation of a package of other reforms, 
will improve quality, promote competition, reduce the Federal burden on 
providers and patients, and focus payments on value instead of volume 
or site of service. Two of these reforms are: (1) a value-based 
purchasing program for hospital outpatient departments and ambulatory 
surgical centers; and (2) a consolidated hospital quality program in 
Medicare to reduce duplicative requirements and create a focus on 
driving improvements in patients' health outcomes. Advancing value in 
Medicare along with the other reforms in the Budget will extend the 
life of the Medicare Trust Fund by 8 years, while also helping to drive 
value and innovation throughout America's entire health system. 
Furthermore, in December the administration released a report entitled 
Reforming America's Healthcare System Through Choice and Competition, 
which contains a series of recommendations to improve the healthcare 
system by better engaging consumers and unleashing competition across 
providers.
 protect the health of americans where they live, learn, work, and play
Combating the Opioid Crisis
    The Administration has made historic investments to address opioid 
misuse, abuse, and overdose, but significant work must still be done to 
fully turn the tide of this public health crisis. The Budget supports 
HHS's five-part strategy to:
  --Improve access to prevention, treatment, and recovery services, 
        including the full range of medication-assisted treatments;
  --Better target the availability of overdose-reversing drugs;
  --Strengthen our understanding of the crisis through better public 
        health data and reporting;
  --Provide support for cutting edge research on pain and addiction; 
        and
  --Improve pain management practices.
    The Budget provides $4.8 billion to combat the opioid overdose 
epidemic. The Substance Abuse and Mental Health Services Administration 
(SAMHSA) will continue all opioid activities at the same funding level 
as fiscal year 2019, including the successful State Opioid Response 
Program and grants, which had a special focus on increasing access to 
medication-assisted treatment--the gold standard for treating opioid 
addiction. At this level, the Budget also provides new funding for 
grants to accredited medical schools and teaching hospitals to develop 
substance use disorder treatment curricula.
    In fiscal year 2020, the Health Resources and Services 
Administration (HRSA) will continue to make investments to address 
substance use disorder, including opioid use disorder, through the 
Rural Communities Opioid Response Program, the National Health Service 
Corps, behavioral health workforce programs, and the Health Centers 
Program.
    Medicare and Medicaid policies and funding will also play a 
critical role in combating the opioid crisis. The Budget proposes 
allowing States to provide full Medicaid benefits for 1 year postpartum 
for pregnant women diagnosed with a substance use disorder. The Budget 
also proposes to set minimum standards for Drug Utilization Review 
programs, allowing for better oversight of opioid dispensing in 
Medicaid. Additionally, it proposes a collaboration between the Centers 
for Medicare & Medicaid Services and the Drug Enforcement 
Administration to stop providers from inappropriate opioid prescribing.
                   the ending hiv epidemic initiative
    Recent advances in HIV prevention and treatment create the 
opportunity to not only control the spread of HIV, but to end this 
epidemic in America. By accelerating proven public health strategies, 
HHS will aim to reduce new infections by 90 percent within 10 years, 
ending the epidemic in America. The Budget invests $291 million in 
fiscal year 2020 for the first phase of this initiative, which will 
target areas with the highest infection rates with the goal of reducing 
the number of new diagnoses by 75 percent in 5 years.
    This effort focuses on investing in existing, proven activities and 
strategies and putting new public health resources on the ground. The 
initiative includes a new $140 million investment in the Centers for 
Disease Control and Prevention (CDC) to test and diagnose new cases, 
rapidly link newly infected individuals to treatment, connect at-risk 
individuals to Pre-exposure prophylaxis (PrEP), expand HIV 
surveillance, and directly support States and localities in the fight 
against HIV.
    Clients receiving medical care through the Ryan White HIV/AIDS 
Program (RWHAP) were virally suppressed at a record level of 85.9 
percent in 2017. The Budget includes $70 million in new funds for RWHAP 
within HRSA to increase direct healthcare and support services, further 
increasing viral suppression among patients in the target areas. The 
Budget includes $50 million in HRSA for expanded PrEP services, 
outreach, and care coordination in community health centers. 
Additionally, the Budget also prioritizes the reauthorization of RWHAP 
to ensure Federal funds are allocated to address the changing landscape 
of HIV across the United States.
    For the Indian Health Service (IHS), the Budget includes $25 
million in new funds to screen for HIV and prevent and treat Hepatitis 
C, a significant burden among persons living with HIV/AIDS. The Budget 
also includes $6 million for the National Institutes of Health's 
regional Centers for AIDS Research to refine implementation strategies 
to assure effectiveness of prevention and treatment interventions.
    In addition to this effort, the Budget funds other activities that 
address HIV/AIDS including $54 million for the Minority HIV/AIDS Fund 
within the Office of the Secretary and $116 million for the Minority 
AIDS program in SAMHSA. These funds allow HHS to target funding to 
minority communities and individuals disproportionately impacted by HIV 
infection.
Prioritizing Biodefense and Preparedness
    The Administration prioritizes the Nation's safety, including its 
ability to respond to acts of bioterrorism, natural disasters, and 
emerging infectious diseases. HHS is at the forefront of the Nation's 
defense against public health threats. The Budget provides 
approximately $2.7 billion to the Public Health and Social Services 
Emergency Fund within the Office of the Secretary to strengthen HHS's 
biodefense and emergency preparedness capacity. The Budget also 
proposes a new transfer authority that will allow HHS to enhance its 
ability to respond more quickly to public health threats. Additionally, 
the Budget supports the government-wide implementation of the 
President's National Biodefense Strategy.
    The Budget supports advanced research and development of medical 
countermeasures against chemical, biological, radiological, nuclear, 
and infectious disease threats, including pandemic influenza. The 
Budget also funds late-stage development and procurement of medical 
countermeasures for the Strategic National Stockpile and emergency 
public health and medical assistance to State and local governments, 
protecting America against threats such as anthrax, botulism, Ebola, 
and chemical, radiological, and nuclear agents.
 strengthen the economic and social well-being of americans across the 
                                lifespan
Promoting Upward Mobility
    The Budget promotes independence and personal responsibility, 
supporting the proven notion that work empowers parents and lifts 
families out of poverty. To ensure Temporary Assistance for Needy 
Families (TANF) enables participants to work, the Budget includes a 
proposal to ensure States will invest in creating opportunities for 
low-income families, and to simplify and improve the work participation 
rate States must meet under TANF. The Budget also proposes to create 
Opportunity and Economic Mobility Demonstrations, allowing States to 
streamline certain welfare programs and tailor them to meet the 
specific needs of their populations.
    The Budget supports Medicaid reforms to empower individuals to 
reach self-sufficiency and financial independence, including a proposal 
to permit states to include asset tests in identifying an individual's 
economic need, allowing more targeted determinations than are possible 
with the use of a Modified Adjusted Gross Income standard alone.
Improving Outcomes in Child Welfare
    The Budget supports implementation of the Family First Prevention 
Services Act of 2018 and includes policies to further improve child 
welfare outcomes and prevent child maltreatment. The Budget also 
expands the Regional Partnership Grants program, which addresses the 
considerable impact of substance use, including opioids use, on child 
welfare.
Strengthening the Indian Health Service
    Reflecting HHS's commitment to the health and well-being of 
American Indians and Alaska Natives, the Budget provides $5.9 billion 
for IHS, which is an additional $392 million above the fiscal year 2019 
Continuing Resolution. The increase supports direct healthcare services 
across Indian Country, including hospitals and health clinics, 
Purchased/Referred Care, dental health, mental health and alcohol and 
substance abuse services. The Budget invests in new programs to improve 
patient care, quality, and oversight. The Budget fully funds staffing 
for new and replacement facilities, new Tribes, and Contract Support 
Costs, ensuring Tribes have the necessary resources to successfully 
manage self-governance programs.
            foster sound, sustained advances in the sciences
Promoting Research and Prevention
    NIH is the leading biomedical research agency in the world, and its 
funding supports scientific breakthroughs that save lives. The Budget 
supports strategic investments in biomedical research and activities 
with significant national impact.
    NIH launched the Helping to End Addiction Long-term (HEAL) 
initiative in April 2018 to advance research on pain and addiction. 
Toward this goal, NIH announced funding opportunities for the historic 
HEALing Communities Study, which will select several communities to 
measure the impact of investing in the integration of evidence-based 
prevention, treatment, and recovery across multiple health and justice 
settings. The Budget provides $500 million to continue the HEAL 
initiative in fiscal year 2020.
    The Budget supports a targeted investment in the National Cancer 
Institute to accelerate pediatric cancer research. Cancer is the 
leading cause of death from disease among children in the United 
States. Approximately 16,000 children are diagnosed with cancer in the 
United States each year. While progress in treating some childhood 
cancers has been made, the science and treatment of childhood cancers 
remains challenging. Through this initiative, NIH will enhance drug 
discovery, better understand the biology of all pediatric cancers, and 
create a national data resource for pediatric cancer research. This 
initiative will develop safer and more effective treatments, and 
provide a path for changing the course of cancer in children.
    The new National Institute for Research on Safety and Quality 
(NIRSQ) proposed in the Budget will continue key research activities 
currently led by the Agency for Healthcare Research and Quality. These 
activities will support researchers by developing the knowledge, tools, 
and data needed to improve the healthcare system.
Addressing Emerging Public Health Challenges
    CDC is the Nation's leading public health agency, and the Budget 
supports its work putting science into action.
    Approximately 700 women die each year in the United States as a 
result of pregnancy or delivery complications or the aggravation of an 
unrelated condition by the physiologic effects of pregnancy. Findings 
from Maternal Mortality Review Committees indicate that more than half 
of these deaths are preventable. The Budget supports data analysis on 
maternal deaths and efforts to identify prevention opportunities.
    The United States must address emerging public health threats, both 
at home and abroad, to protect the health of its citizens. The Budget 
invests $10 million to support CDC's response to Acute Flaccid Myelitis 
(AFM), a rare but serious condition that affects the nervous system and 
weakens muscles and reflexes. With this funding, CDC will work closely 
with national experts, healthcare providers, and state and local health 
departments to thoroughly investigate AFM.
    The Budget also provides $100 million for CDC's global health 
security activities. Moving forward, CDC will implement a regional hub 
office model and primarily focus their global health security capacity 
building activities on areas where they have seen the most success: lab 
and diagnostic capacity, surveillance systems, training of disease 
detectives, and establishing strong emergency operation centers. In 
addition, CDC will continue on-going efforts to identify health 
emergencies, track dangerous diseases, and rapidly respond to outbreaks 
and other public health threats around the world, including continuing 
work on Ebola response.
    The Budget also strengthens the health security of our Nation by 
continuing CDC's support to State and local government partners in 
implementing programs, establishing guidelines, and conducting research 
to tackle public health challenges and build preparedness.
    Innovations in the Food and Drug Administration
    FDA plays a major role in protecting public health by assuring the 
safety of the Nation's food supply and regulating medical products and 
tobacco. The Budget provides $6.1 billion for FDA, which is an 
additional $643 million above the fiscal year 2019 Continuing 
Resolution. The Budget includes resources to promote competition and 
foster innovation, such as modernizing generic drug review and creating 
a new medical data enterprise. The Budget advances digital health 
technology to reduce the time and cost of market entry, supports FDA 
opioid activities at international mail facilities to increase 
inspections of suspicious packages, strengthens the outsourcing 
facility sector to ensure quality compounded drugs, and pilots a 
pathogen inactivation technology to ensure the blood supply continues 
to be safe. FDA will continue to modernize the food safety system in 
fiscal year 2020.
       promote effective and efficient management and stewardship
    Almost one quarter of total Federal outlays are made by HHS. The 
Department employs more than 78,000 permanent and temporary employees 
and administers more grant dollars than all other Federal agencies 
combined. Efficiencies in HHS management have a tremendous impact on 
Federal spending as a whole.
Advancing Fiscal Stewardship
    HHS recognizes its immense responsibility to manage taxpayer 
dollars wisely. HHS ensures the integrity of all its financial 
transactions by leveraging financial management expertise, implementing 
strong business processes, and effectively managing risk.
    In an effort to operate Medicare and Medicaid efficiently and 
effectively, both to rein in wasteful spending and to better serve 
beneficiaries, HHS is implementing actions such as enhanced provider 
screening, prior authorization, and sophisticated predictive analytics 
technology, to reduce improper payments in Medicare and Medicaid 
without increasing burden on providers or delaying Americans' access to 
care or to critical medications. HHS continues to work with law 
enforcement partners to target fraud and abuse in healthcare, and the 
Budget increases investment in healthcare fraud and abuse activities. 
The Budget includes a series of proposals to strengthen Medicare and 
Medicaid oversight, including increasing prior authorization,enhancing 
Part D plans' ability to address fraud, and strengthening the 
Department's ability to recoup overpayments made to States on behalf of 
ineligible Medicaid beneficiaries.
Implementing ReImagine HHS
    HHS eagerly took up the call in the Administration's Government-
wide Reform Plan to more efficiently and effectively serve the American 
people. HHS developed a plan --``ReImagine HHS''--organized around a 
number of initiatives.
    ReImagine HHS is identifying a variety of ways to reduce Federal 
spending and improve the functioning of HHS's programs through more 
efficient operations. For example, the Buy Smarter initiative 
streamlines HHS's procurement process by using new and emerging 
technologies.
                               conclusion
    Americans deserve healthcare, human services, and public health 
programs that work for them and make good use of taxpayer dollars. The 
men and women of HHS are committed, innovative, hardworking public 
servants who work each day to improve the lives of all Americans. 
President Trump's fiscal year 2020 Budget will help advance us toward 
that goal, accomplish the Department's vital mission, and put 
Americans' health first.

    Senator Blunt. Well, thank you.
    Now we will get to those questions. I am hopeful that we 
can get through most of our questions by the vote and leave 
sometime shortly after 11:45. But if we do not, I will come 
back. And there will be a second round of questions for anybody 
that wants it. So I would ask everybody, including me, to stick 
with their time limit.

                     ORGAN/LIVER ALLOCATION POLICY

    So the first question I almost got into a moment ago is 
about the new liver allocation policy, the solid organ 
allocation policy, something that Senator Moran and I have been 
very interested in. We had one meeting with the Organ 
Transplant Procurement Network group, and frankly our view of 
that meeting was very different than what they finally did. 
Both the University of Kansas and Washington University in St. 
Louis are really among the leading stakeholders in this in 
terms of the transplants that they are part of.
    I guess the problem is that States in the Midwest, States 
in the South, States that have lots of small communities tend 
to be much greater organ donors. And obviously, as long as we 
had a regional view of this, that was a benefit to their 
neighbors.
    There has been a dramatic decrease in availability of lung 
and liver transplants at Barnes-Jewish Hospital in St. Louis 
since the new lung policy went into effect.
    I think there will certainly be a lawsuit filed here. Will 
you commit today that you will ask OPTN (Organ Procurement and 
Transplantation Network), the transplant group, not to move 
forward with this controversial policy until that lawsuit has 
been dealt with?
    Secretary Azar. Well, Mr. Chairman, I am concerned about 
the liver allocation policy issues you raised. Frankly, any 
transplant organ allocation policy issues are quite difficult 
politically and as a matter of public health. I received a 
letter from you and many others about the most recent organ--
the liver transplantation allocation policies out of OPTN. And 
we requested of them to think again and to ensure--I believe it 
was--was it the Kansas and Missouri providers that we wanted to 
ensure, especially that comments that came in at the last 
minute or perhaps came in late were fully considered by OPTN.
    We recently received a letter back in response to my 
challenge to them, which I believe your staff has access to, 
where basically they said they went through the procedures. 
They considered all of the comments, and they remained 
steadfast in their conclusion regarding the science and 
technical aspects of the allocation decision they made.
    I do believe my cards are played out here. Congress 
deliberately set up the OPTN system to keep people like me from 
actually dictating the policy allocations. But I am happy to 
work with the committee on any other solutions here to look at 
and ensure that the fair and scientifically valid treatment has 
been given here.
    Senator Blunt. Well, I would think that one of the reasons 
the old system worked was that people were more encouraged to 
be donors if they believed that people in their community would 
benefit from that.
    On liver transplants under the new policy, we think there 
would be 32 percent fewer transplants in Missouri. I think 
Barnes-Jewish Hospital is number four or five in the country in 
transplants. And they have told me since this started, they are 
now having to send teams of doctors across the country to get 
organs that would have been available under the old policy 
locally. I think it has further complicated and added expense 
and precious time to the system.
    We are going to continue to watch that.

                      UNACCOMPANIED ALIEN CHILDREN

    Let me ask one more question here on a big issue, and that 
is your role in providing security and taking care of 
unaccompanied children. You have nothing to do with border 
security, but you wind up with a great responsibility. Would 
you talk about how that has changed in the last few months?
    Secretary Azar. Absolutely, Mr. Chairman.
    We are in a tremendous crisis at the border right now. We 
are getting 300 to 350 unaccompanied alien children crossing 
the border and referred to HHS every single day right now. 
These are 10, 12, 13, 15-year-old kids. They are not coming 
with parents. They are coming across the border by themselves. 
And these are historic levels for us. That is a 97 percent 
increase in February from the previous year February. It is 
just not sustainable at this rate.
    I know the ranking member raised in her opening statement 
concern about temporary influx facilities. I will work with 
this committee to do anything we can to take care of the 
children appropriately, any ideas you have how to ensure that 
we are doing that well. I would love to enhance our fixed 
permanent capacity. It is cheaper. It is more economical. We 
have been working on that. It is slow to do. You understand 
government procurements and government contracting around 
leasing is slow.
    We need help. We need help, and at this rate, the funding 
even for this year will not be satisfactory. And I want to be 
transparent with this committee in particular about that. We 
are working with OMB (Office of Management and Budget) on what 
that total funding needs could be at the current rate, but it 
would exceed where we are even with the transfer and 
reprogramming that I notified the committee about. It is beyond 
belief, the level of children that are coming across the border 
right now.
    Senator Blunt. And in your case, the unaccompanied 
children.
    Secretary Azar. These are unaccompanied children. These are 
kids just coming across. They do not have a parent with them. 
They are coming by themselves.
    Senator Blunt. All right. I have more questions on this, 
but I am going to stick with my time restraint. I have a 
feeling they will be asked by others. If not, I will ask them 
when we get to another round.
    Senator Murray.
    Senator Murray. Thank you. Thank you, Mr. Chairman.
    Mr. Secretary, despite continued assertions that your 
budget guarantees affordable healthcare and protects people 
with preexisting conditions, the fact is that the 
administration is doing everything it can to actually sabotage 
healthcare. And this budget appears to be just more of the 
same. This budget continues to push harmful policies that 
undermine healthcare for millions of people across the country.

                          AFFORDABLE CARE ACT

    Your budget calls for repealing and replacing the ACA 
(Affordable Care Act) with the failed Trump Care bill, which 
was rejected last Congress, and in his clearest message yet to 
patients and families, that he sees their healthcare coverage 
as nothing more than some kind of political football, last week 
President Trump sided with the ruling that all of the ACA 
should be struck down. All of it.
    Now, according to reports, you initially opposed President 
Trump on that and issued a statement of support.
    So I wanted to ask you today, did you initially object to 
the President's decision to side with the Texas court? Because 
you know the impact that this would have. It would be 
devastating for so many families.
    Secretary Azar. As you can appreciate, the advice of a 
cabinet member to the President of the United States is highly 
confidential and it would not be appropriate for me to comment 
on that.
    What I would say is the position the administration took in 
the Affordable Care Act litigation is an appropriate position, 
supporting a district court's decision. Reasonable minds can 
differ on this question of legal issues.
    This is not our policy position. That is a legal conclusion 
about the ACA, and that litigation, which we did not bring--we 
are a party. I am the party in the litigation, but we want to 
protect preexisting conditions, if the litigation ends up in 
that position. We want to work with you to secure better care 
for people and make sure all the types of issues you have 
raised are taken care of in any kind of new legislation.
    Senator Murray. Well, let me just ask you. As Secretary of 
Health, do you agree that if this ruling is upheld, as the 
administration is arguing for, it will result in tens of 
millions of people losing their coverage and allow insurers to 
discriminate against people with preexisting conditions if it 
is upheld?
    Secretary Azar. Well, the burden would be on us to work 
together to actually come up with a better care plan.
    Senator Murray. That is not the question. The question if 
the court goes through with the ruling, as you have requested 
them to, will it result----
    Secretary Azar. Well, you would not have Medicaid expansion 
and you would not have the exchange subsidies, and we would 
work with you to come up----
    Senator Murray. And preexisting conditions.
    Secretary Azar [continuing]. With a better system that 
actually we hope delivers better care for people.
    Senator Murray. I have heard that before. But it would mean 
that people with preexisting conditions would lose their----
    Secretary Azar. The President will never agree to any 
legislation that does not protect people with preexisting 
conditions.
    Senator Murray. I am not asking about legislation. I am 
asking about the court decision.
    Secretary Azar. A legal interpretation of a court case is 
not a policy position about what we want to have happen for 
people with preexisting conditions. We are going to fight for 
people with preexisting conditions under all circumstances, but 
a legal judgment filed by the Justice Department is different 
than a policy position to work with you to protect people with 
pre-ex.
    Senator Murray. Well, it is pretty clear if the 
administration goes after this in court and wins, people will 
lose their preexisting conditions at that point.

                                TITLE X

    So let me just go on. I wanted to ask you about Title X. As 
you know, I am really concerned about this administration's 
constant efforts to undermine the historically bipartisan Title 
X family planning program. It is the only Federal program 
dedicated to contraceptive healthcare and family planning 
services and actually helps 4 million people annually get 
services like cancer screenings, contraception, crucial 
preventive health services.
    Your Title X domestic gag rule will take effect very soon, 
and it will bar providers from talking to their patients about 
all the family planning options. The American Medical 
Association has actually called that rule, ``a violation of 
patients' rights under the Code of Medical Ethics.'' And they 
have actually joined Planned Parenthood to fight that in court.
    You also announced the Title X grant recipients for 2019, 
dropped five Planned Parenthood affiliates, make it harder for 
tens of thousands of women to get the care they need, instead 
have ordered funding to an ideologically driven organization 
that does not even offer FDA-approved birth control. And you 
notified, as I mentioned earlier, your intent to reorganize the 
offices that administer both the Title X and teen pregnancy 
prevention.
    So I just have a few seconds left. If you can answer yes or 
no. I wanted to ask you, is birth control an evidence-based 
family planning option?
    Secretary Azar. We support the full range of family 
planning. That is why we fully funded and kept the Title X 
program flat funding even as we cut other parts of the budget. 
So we do support access to contraception and birth control and 
the full range of family planning options.
    Senator Murray. And you believe birth control is an 
evidence-based family planning program.
    Secretary Azar. It is part of the Title X program and we 
support that.
    Senator Murray. Well, should HHS award scarce Federal 
funding family planning dollars to entities that do not 
prescribe or provide birth control?
    Secretary Azar. So the one entity that you are referring to 
actually as part of its grant is required to have--there are 
going to be seven federally qualified health centers that are 
actually part of their--these are always done as a program with 
a grantee and sub-grantees. So they have to offer across the 
program the full range of family planning alternatives required 
by statute.
    Senator Murray. Including birth control.
    Secretary Azar. Yes. So they will have other providers in 
there, the seven FQHCs (federally Qualified Health Center) that 
are a----
    Senator Murray. So it will make it harder for women. They 
got to get pushed around. I get it. Okay.
    And my time is out.
    Senator Blunt. Thank you, Senator Murray.
    Senator Alexander.
    Senator Alexander. Thank you, Mr. Chairman.
    Welcome, Mr. Secretary.

                              NIH FUNDING

    Let me first pass a compliment to Senator Blunt and Senator 
Murray, the ranking member, and other members of the 
subcommittee for 3 consecutive years of significant--4 
consecutive years of significant increases of funding for the 
National Institutes of Health. We see the results of that 
everywhere, and I fully support it. And I thank you for your 
leadership. Senator Murray, Senator Durbin, and you have been 
consistent supporters of that.

                   ENDING THE HIV EPIDEMIC INITIATIVE

    Second, to the President, to you, I am proud of the 
initiative that seeks to reduce HIV infections by 75 percent in 
the next 5 years, 90 percent in the next 10 years. I hope you 
will focus especially on those parts of the country where that 
is a special problem. African Americans account for 43 percent 
of HIV diagnoses. In 2016, more than 84 percent of the people 
in Memphis in HIV were African American. And of the estimated 
new HIV diagnoses in Tennessee, more than 25 percent were in 
Memphis alone.

                          MEDICARE WAGE INDEX

    And I want to call to your attention the Medicare area wage 
index, which I will not ask you a question about, but that is 
continuing to be a reason why hospitals, especially in rural 
Tennessee and other parts of rural America, close because of 
the unfairness of that index.

                          AFFORDABLE CARE ACT

    Now, Mr. Secretary, I heard the question by the Senator 
from Washington about the Affordable Care Act. I think it is a 
pretty far-fetched case in my opinion, but I am not the judge. 
I am pretty sure that if there were any decision that resulted 
in the Affordable Care Act being overturned, that the court 
would stay the effect of the decision, giving Congress and the 
President time to do whatever they wanted to do.
    Let me ask you this question. Have you made any changes in 
the way you are administering the Affordable Care Act as a 
result of the Department of Justice's position on this 
litigation?
    Secretary Azar. We have and will not make any changes to 
how we administer the Affordable Care Act in light of the 
litigation. It could be a year, 2 years before we get any final 
ruling by an ultimate--final court of jurisdiction. I have 
instructed my team, my organization. We continue to implement 
the Affordable Care Act faithfully and fully across the board 
without regard to litigation positions taken by the 
administration in court.
    Senator Alexander. So whether you like it or not, you 
recognize it is the law.
    Secretary Azar. Absolutely.
    Senator Alexander. On a separate question, the committee 
that I am Chairman of and Senator Murray is the ranking member, 
the Health Committee, has been working with the Finance 
Committee, Senators Grassley and Widen, for the last several 
months to see if we could identify a series of steps to reduce 
healthcare costs. Testimony before our committee is that up to 
half of healthcare costs are unnecessary. We are working on 
that the same way we worked on opioids, which means Democrats 
and Republicans working together, various committees working 
together, staffs working together. So far, so good. Our goal in 
the HELP (Health, Education, Labor and Pensions) Committee is 
to see if we can produce a recommendation, a markup for the 
full Senate by June or July.
    Are you and the administration willing to work with us and 
support our efforts to address these issues like surprise 
medical bills, prescription drugs, direct primary care, 
transparency, rebates, and other issues? If we are going to 
work in a bipartisan way, is the administration willing to 
support our efforts to get a result in this way?
    Secretary Azar. We are fully supportive of the efforts of 
you, Senator Murray, Chairman Grassley, and Senator Wyden 
working together on a bipartisan basis across all of those 
issues.

                                OPIOIDS

    Senator Alexander. On opioids, President Trump asked the 
president of China to make all forms of ethanol illegal in 
China, and China has announced that it will do that starting 
May 1st. I want to congratulate you and the President for that 
and thank the officials of China for that because our Drug 
Enforcement Agency has told us that, one way or the other, most 
of the fentanyl that comes into the United States starts in 
China. I do not have time for you to answer a question.
    But as we think about opioids, I hope that you will keep an 
eye on the effect it is having on people with pain while we are 
getting rid of opioids that are used inappropriately. We want 
to make sure that they are used appropriately by doctors. And 
the CDC (Centers for Disease Control and Prevention) 
guidelines, about which there will be a report in May, and the 
FDA report in August should be seen as advice and guidelines, 
leaving the decisions in the hands of individual doctors, and I 
hope you will help us do that.
    Thank you, Mr. Chairman.
    Senator Blunt. Thank you, Senator Alexander. And I want to 
say that having you and Senator Murray on this committee to 
speak on things like the healthcare issues and moving forward 
on NIH research makes a real difference, having both of you 
here as the leaders of the authorizing committee, and your 
leadership has really mattered particularly on what we have 
been able to do at NIH (National Institutes of Health). And 
nobody has been more involved in that than Senator Durbin.
    Senator Durbin.
    Senator Durbin. And congratulations to you and Senator 
Murray. This 4 years consistent 5 percent real growth at NIH is 
saving lives. The President's recommendation of making a cut in 
medical research I believe will be roundly dismissed by both 
political parties, and I hope that that is the outcome soon. I 
thank you all, including Senator Alexander.
    So, Mr. Secretary, I have so many questions and so little 
time, as they say.

                      UNACCOMPANIED ALIEN CHILDREN

    Let me go to this unaccompanied children issue for a 
minute. When I asked the Inspector General to investigate the 
zero tolerance policy of the Trump administration, which 
forcibly removed over 2,800 children from their parents when 
they came to the United States, we were told that in fact the 
public announcement of this program actually postdated the 
initiation by as much as a year, that there could have been 
thousands that had not been disclosed prior to the 
announcement.
    When did you first become aware, Mr. Secretary, of the 
President's zero tolerance policy?
    Secretary Azar. So I became aware of the Attorney General's 
zero tolerance initiative basically when he announced it in the 
public. I learned of it in the media in April when the zero 
tolerance was announced at that point. Then subsequently as we 
have been going through this I believe in the summer or late 
summer, whenever--maybe it actually might have even been 
through the Inspector General's work that you asked for--
learned of some of the previous piloting or demonstration work 
that may have been occurring, a lot of it prior to my even 
arriving at HHS.
    Senator Durbin. How many children were affected by this 
piloting or demonstration effort?
    Secretary Azar. Well, as the Inspector General said, there 
was a surmise there only of numbers. The Inspector General just 
said that there could be a couple of thousand but did not know 
how many in that case.
    Senator Durbin. Did you play any role in crafting this 
policy of zero tolerance?
    Secretary Azar. No. How could I if I learned about it in 
April when it was announced?
    Senator Durbin. So let me ask you about unaccompanied 
children now. You say there is an inflow or 300 to 350 
unaccompanied children a day coming into the system. Your 
website says that you have facilities for placement of up to 
14,000 children and currently some 12,000 are placed in your 
facilities. Is that correct?
    Secretary Azar. So as of this morning, we have 12,340 
children in our care. We have got 428 available beds, with 
another 1,314 beds subject to--that could be available but are 
usually--it is an issue of getting adequate staffing to be able 
to bring them online. We are very tight right now, Senator.
    Senator Durbin. Understood.
    And what is the outflow of children who are actually sent 
to families or placed outside your facilities?
    Secretary Azar. So our discharge rate has been quite high 
lately actually. We have really been prioritizing and working 
on that. Our discharge rate on a 30-day reference has been 2.0 
children per 100 children on discharge, and on the 7-day, we 
are actually 2.4 children per 100. I think as I have looked in 
the last couple of weeks, we are essentially adding almost 70 
to 80 children per day just because of the inflow and outflow 
rates.
    Senator Durbin. So is it true, as we have been reading, 
that these children are primarily coming from three countries?
    Secretary Azar. That is absolutely correct. It is 
Guatemala, El Salvador, and Honduras. One of the particular 
challenges lately has been we have been getting--it is a lot 
easier for us to place children out where they have one parent 
here in the United States or a close relative because with the 
TVPRA (Trafficking Victims Protection Reauthorization Act), we 
can make that a faster process to check on them. Some of the 
children--we have been getting an increasing mix of Guatemalan 
male teenagers who have no family connections here. Those 
become extremely difficult for us to try to place out.
    Senator Durbin. I understand that part of it.
    It is interesting to note that these children are coming 
from three countries, not Nicaragua, not Costa Rica, not 
Mexico, but these three countries that the President now says 
he wants to cut off all foreign aid to these countries, 
believing in his mind that that is somehow going to solve the 
problem. I think it will make it much worse.
    I think it is also important to note that this 
administration eliminated the program where children could go 
through the screening in home country at the local Embassy, the 
U.S. Embassy and consulate. And now many of these families in 
their desperation have no other recourse to test their asylee 
status than come to the border of the United States and present 
themselves.
    So would you not believe that it would be helpful if we had 
a system restored, as it was under the Obama administration, 
for screening that begins in country?
    Secretary Azar. Senator, I am not an immigration law 
expert. I had not known about that program in country. It 
actually seems consistent with the discussions that I have 
heard from Secretary Nielsen about the desire to have asylum 
claims adjudicated while people are in country. I will be happy 
to raise that with her and see.
    Senator Durbin. Please do. She was part of the group that 
eliminated it. And so I hope that you will raise it.

                              DRUG PRICING

    I have a lot of really good questions on prescription drug 
pricing.
    Secretary Azar. I hope we can keep working together, you 
and I, and I really appreciate your support on direct-to-
consumer advertising.
    Senator Durbin. Listing the price is favored by 88 percent 
of the American people. Thank you, on a regulatory basis, for 
moving on this. We did include it in the appropriation bill in 
the last round.
    Secretary Azar. We got close.
    Senator Durbin. We got close. It was killed in the 
conference in the House, but I am hoping and praying that 
Senator Blunt and others will stand behind restoring that.
    Secretary Azar. I would encourage you to take a look in the 
Office of Management and Budget's ROCIS system which is where 
regulations are filed when sent over to OMB for review. There 
is a rule with a title referring to a final rule related to 
direct-to-consumer advertising pending at OMB.
    Senator Durbin. Thank you.
    Senator Blunt. Thank you, Senator Durbin.
    Senator Moran.
    Senator Moran. Chairman Blunt, thank you very much.
    Secretary, thank you for being here.
    Let me raise just a topic, and then I want to continue 
where Senator Blunt left off in regard to the transplant 
program.

               FRAUD AND ABUSE/CRITICAL ACCESS HOSPITALS

    I want to highlight for you that we have three hospitals in 
Kansas, Horton, Hillsborough, and Oswego, small rural 
hospitals, all of them critical access hospitals. The thing 
they have in common: they are owned by a company called 
EmpowerHMS. EmpowerHMS has been investigated by CMS (Centers 
for Medicare & Medicaid Services) for billing fraud, but as a 
result of that and other factors, business factors, management 
factors, those three hospitals are in various conditions, 
either shut down or have a trustee in bankruptcy attempting to 
operate those hospitals.
    And I would, first of all, encourage you not to change your 
enforcement procedures or not to in any way pursue fraudulent 
behavior any less, but recognize there is a consequence to a 
community hospital that, regardless of who the owner of the 
hospital is who can be gone that night, the community is left 
in a circumstance in which their hospital is no longer 
functioning.
    And so I would hope that CMS and others at Health and Human 
Services, perhaps in conjunction with our State and others, can 
have a plan in place that when you are creating a circumstance 
that forces a business out of business because of fraud, the 
end result is that the person who committed the fraud, the 
company who committed the fraud is who pays the price, not the 
community who no longer has a hospital. And I would welcome any 
thoughts that you or your folks at CMS could provide in this 
particular case, but just generally, there is a consequence for 
this bad behavior.
    And I hope that whatever bad behavior is determined, if you 
determine that, that if appropriate, it is referred to the 
Department of Justice because the consequences for this 
behavior is long-term generational consequences to communities 
and the people who live there just of significant challenges 
now as a result of--in addition to the challenges we just have 
in keeping hospital doors open generally in communities across 
Kansas.

                        LIVER ALLOCATION POLICY

    In regard to the liver allocation issue, Mr. Secretary, let 
me ask just a couple of questions and then express my concern 
and dissatisfaction.
    Let me first ask if you believe that enough is being done 
to help individuals with end stage liver disease who are not 
yet on the wait list. So there is another population, those who 
are on a wait list waiting for a liver transplant. There are 
those who are not on the wait list yet. Is enough being done to 
advance their well-being?
    Secretary Azar. I think the number one thing that we can 
all be doing is working, as the Chairman referred to earlier, 
to increase the supply of livers that we have for 
transplantation. That is the most important thing we could do 
to help with advancing individuals.
    I hope we are doing everything that we can with regard to 
care for individuals suffering from liver disease awaiting 
transplant. If there are things that we could be doing 
differently, please do let me know. I would want to make sure 
we are doing that.
    Senator Moran. Would you commit the Department to a full 
public disclosure, a transparent public debate on this organ 
allocation transplant process?
    Secretary Azar. I am happy to work with you on what that 
might look like. As I mentioned to the Chairman, the challenge 
with this OPTN organ allocation issue is that Congress 
deliberately took that out of my hands to make it a non-
political issue. And so when we do not like a conclusion, I am 
fairly restricted in what I can do. But I believe the OPTN 
process was a public process with a public record, but I am 
happy to work with you and your staff on any vehicle to ensure 
that.
    Senator Moran. Mr. Secretary, you are moving me to my 
complaining aspect by your comments----
    [Laughter.]
    Senator Moran [continuing]. Because it was only after a 
lawsuit was filed, as I understand it, that this allocation 
process was then considered for change. And when you tell me 
that we constructed the ground rules for you to be removed from 
the process, you do appoint the HRSA (Health Resources and 
Services Administration) director. The HRSA director is one who 
has written a letter to OPTN encouraging them to quickly 
implement the decision that they made and encouraging them.
    I would also tell you that while, from time to time in this 
job, people tell me something that does not always turn out to 
be true. But in our meeting Senator Blunt and I had with the 
HRSA director, the request was that we make certain that our 
constituencies, transplant programs in our States, submit not 
just comments but please bring us a proposal because we are so 
interested in listening to the proposal. Do not just complain 
about the proposal that is out there. Tell us how to do it 
better.
    And I can tell you that the end result of our programs 
doing that--they were not considered. And in fact, the decision 
was made before those comments were submitted, before that 
proposal was submitted by our constituents. I wrote down what 
you said in a last minute or late, the computer program shut 
down because there were so many comments. The only lateness of 
our programs supplying their comments and proposals was because 
the computer was shut down because of commentary. And the 
decision was made before these were ever read, and then they 
were approved with no changes thereafter.
    The original decision was made by the Liver and Intestine 
Committee and without ever seeing the comments of our 
constituents. Then secondly, it was approved immediately with 
no change even though you can claim, perhaps correctly, that 
the comments were then read after the initial decision was 
made.
    My point is that while I am often--perhaps I misunderstand 
what has been requested of me or what my instructions are of 
how I can be of help to my constituents. What I think we did 
was exactly what we were told to do with no beneficial thing 
happening as a result of following those instructions.
    So this process has been flawed and it is a flaw that 
arises out of the fear of a lawsuit. And after a long period of 
time--I know what you are saying, Chairman Blunt.
    [Laughter.]
    Senator Moran. After a long period of time, the policy in 
place was changed almost overnight in response to a lawsuit.
    And you are right. The issue is more organ donation and the 
policy that is being developed is contradictory to what you 
said is the goal.
    I will be back for the second round.
    Senator Blunt. Senator Merkley.
    Thank you, Senator Moran.
    Senator Merkley. Thank you very much.

                      UNACCOMPANIED ALIEN CHILDREN

    You mentioned that there is a big influx of unaccompanied 
minors crossing the border. And are you referring to people 
crossing between ports of entry?
    Secretary Azar. We will receive the 300 to 350 children 
from wherever they show up. If they show up at a border 
crossing alone, if they show up at a non-border crossing alone, 
they are UACs (unaccompanied alien children) how they came 
across. Or even if they were already resident and come into 
Federal authorities and they are unaccompanied alien children, 
they will be referred to us no matter what. So I do not know 
where they crossed the border.
    Senator Merkley. So they are in Tijuana where you are 
saying that youth can walk up to the port of entry and present 
themselves?
    Secretary Azar. If a child comes up to the border, presents 
himself and is a 12-year-old, a minor, say, a 12-year-old, and 
is an unaccompanied alien child, I believe at that point, 
subject to whatever the rules of DHS (Department of Homeland 
Security) are--I am not DHS. We would have to ask Secretary 
Nielsen. I believe that once they cross the border and if they 
are not immediately repatriatable, that they are sent to us.
    Senator Merkley. So this is not the way it works, and I 
would encourage you to learn a lot more about this. Right now, 
if an unaccompanied minor comes to the border in San Diego, 
they are not allowed to present themselves at the border. 
Everyone who is 18 and up is instructed to return to Mexico to 
get into the book. This is the metering process. But if you are 
under 18, you are not allowed to get into the book and you are 
not allowed to cross the border.
    So we are leaving these children permanently exiled in 
Tijuana with really no choice about how to proceed that is a 
good choice. If they present themselves to the Mexican 
authority DIF, they are deported back into horrific 
circumstances. If they stay in Tijuana, they are subject to 
gangs and the sex predators that have a big sex industry there. 
And so their best option is to cross the border illegally.
    So while the President of the United States is telling the 
world do not cross between ports of entry, we are blocking the 
minors from crossing in the ports of entry. Do you think that 
that is acceptable?
    Secretary Azar. I do not know border law----
    Senator Merkley. Well, I encourage you to find out because 
you are very directly affected by it. And it is why so many 
minors are crossing between ports of entry rather than at ports 
of entry because they are being blocked. And the fact that you 
have not educated yourself about this horrific treatment of 
children at the hands of the U.S. Government really is 
unacceptable.
    Second, you said that you have sent a letter to Congress to 
fund an expansion of the child prison system under this 
administration. What expansion level are you planning to go to?
    Secretary Azar. So we sent a funding and reprogramming 
request that--not a request, but basically a transfer message 
that we were transferring $286 million using the Secretary's 15 
percent transfer authority and then reprogramming $99 million 
of money that is not needed for the refugee program within ORR 
as part of the transfer and reprogramming----
    Senator Merkley. So $385 million on top of the $266 
million----
    Secretary Azar. And at this current rate, as I mentioned to 
the Chairman, that will not prove adequate for this year.
    Senator Merkley. What is the capacity of the child prison 
system that you are seeking with this money?
    Secretary Azar. So that actually is supportive of our 
current rates of about 14,000 beds I believe, as well as our 
expected added--we are trying to add as many fixed beds as we 
can to care for them.
    You keep saying ``prison system.'' If you got an 
alternative approach to how to care for these children, please 
tell us because it would be nice if you told us how to do that.
    Senator Merkley. Let me explain it to you.
    Secretary Azar. If there is a better way, we want to be 
compassionate and deliver a safe, secure----
    Senator Merkley. Yes, okay. Well, you asked me. We will 
have a little dialogue here. It is called sponsors. And the 
reason it is so hard to get sponsors right now is the 
administration is telling potential sponsors that all their 
information will be shared with ICE (Immigration and Customs 
Enforcement). Therefore, people are not coming forward to be 
sponsors because they do not want to be stuck into our criminal 
examination system.
    Secretary Azar. I believe the Congress actually passed an 
appropriations rider limiting the use of any information that 
would get to DHS as part of the background checking that we do 
as part of our sponsorship checks. So I think that is probably 
dated information.
    Senator Merkley. But unfortunately, the families are still 
being told that their information could be used in this 
capacity. So as long as you are still telling families that, 
then they are discouraged from coming forward.
    Secretary Azar. I will be happy to look at that to see. I 
was not aware they were being told that. I will be happy to 
look at that for you.
    Senator Merkley. These children belong in homes----
    Secretary Azar. They do.
    Senator Merkley [continuing]. And schools and parks, not 
locked up. I call them prisons because they are locked up. I do 
not know if you have visited these facilities, but I have.
    Secretary Azar. I do frequently.
    Senator Merkley. Okay. Well, then you understand what I am 
talking about.
    Secretary Azar. I completely agree with you. I do not want 
any child in our custody. I want every child out with an 
appropriate, safely vetted sponsor in the community.
    Senator Merkley. Then please examine the reasons why it is 
so hard to recruit sponsors because that will facilitate. And 
it is also costing a huge expense, this temporary influx, $750 
a day for a for-profit operator to run a former air base 
facility when a permanent facility costs much less. And with 
sponsors, it costs a fraction, just a fraction to have a case 
worker working with those families. So not only is it much 
better for the children as they wait an asylum process, it is 
much better for the American taxpayer. And maybe it means less 
profits for these for-profit companies you are hiring to run 
Homestead, but should you not watch out for the taxpayers and 
the children instead?
    Secretary Azar. Senator, I completely share your goal and 
my goal and the government's goal that these children should be 
with sponsors and not in our care.
    Senator Merkley. Good.
    Secretary Azar. If we can work together to make that 
happen, I will be delighted to work with anyone to make that 
happen.
    Senator Merkley. Let us just note that they are in 
Homestead in Florida. They have not undertaken to address the 
child abuse and neglect checks for the staff members so that 
they can make sure that the individuals they hire working with 
these kids do not have a record as a sexual predator. And that 
is unacceptable.
    Thank you.
    Senator Blunt. Thank you, Senator Merkley.
    Senator Kennedy.

                      UNACCOMPANIED ALIEN CHILDREN

    Senator Kennedy. Thank you, Mr. Chairman.
    Thank you, Mr. Secretary.
    Mr. Secretary, do you believe in the rule of law?
    Secretary Azar. Yes, I do especially as a trained lawyer. I 
do, indeed.
    Senator Kennedy. Is it illegal to come into our country 
illegally?
    Secretary Azar. It is, indeed, illegal to come into our 
country illegally.
    Senator Kennedy. Do you dislike children?
    Secretary Azar. I love children, and I want to care 
compassionately for any child I am ever entrusted with.
    Senator Kennedy. Are you trying to hurt children who are 
coming into our country at the border?
    Secretary Azar. No. I am proud to lead an organization of 
people and have grantees that are some of the most 
compassionate, caring child welfare people that I have ever 
interacted with who love these children and care deeply for 
them.
    Senator Kennedy. I read where in March we had about 100,000 
folks, mostly from Central America, mostly family units and 
children come into America illegally across our southern 
border. Does that sound about right?
    Secretary Azar. That is my information is it is about 
100,000 coming across now in family units per month, and it has 
created an absolute crisis for my colleagues at the Department 
of Homeland Security.
    Senator Kennedy. Ten times more than--or double what it was 
I think 10 years ago, something like that.

                          AFFORDABLE CARE ACT

    Let me ask you about the Affordable Care Act. I remember 
when Congress passed it. We were promised--we meaning I am 
American like you are. We were promised two things. We were 
promised, number one, that it would make health insurance 
cheaper, more affordable. Has it done that?
    Secretary Azar. No, it has not. We were promised that 
health insurance would cost half what it cost at the time. In 
fact, during President Obama's tenure, it doubled in cost for 
people having to buy insurance.
    Senator Kennedy. I remember vividly because I watched it on 
C-SPAN. I remember Congress also promised us that it would make 
health insurance more accessible. Has it done that?
    Secretary Azar. No, it has not. In fact, it has restricted 
choices for individuals now with a large percent of States 
having only one carrier in the individual market.
    Senator Kennedy. All right. Now, let me ask you this. The 
President has expressed his disappointment with the Affordable 
Care Act. Does he support getting rid of it before we have a 
replacement?
    Secretary Azar. The President has always supported 
replacing the Affordable Care Act with something else that is 
better, never that there should be nothing.
    Senator Kennedy. I want to be sure I understand because 
there has been some innuendo here. Does he support getting rid 
of the Affordable Care Act without a better plan in place?
    Secretary Azar. Absolutely not. He insists there be a 
better plan in place for people.
    Senator Kennedy. Do you know of anyone on Capitol Hill, 
Republican or Democrat, who supports a healthcare insurance 
program or a healthcare delivery system that would not cover 
preexisting conditions?
    Secretary Azar. I have not met them.
    Senator Kennedy. Does the President support a replacement 
plan for Obamacare that would cover preexisting conditions?
    Secretary Azar. He does, indeed, and he will never sign any 
other plan that does not take care of people with preexisting 
conditions.
    Senator Kennedy. I want to look at the healthcare system 
from 30,000 feet for a second. Here is what I do not 
understand. I keep reading that 10 percent of the American 
people spend about 67 percent of the healthcare dollars, which 
makes sense because we all know that the chronically ill spend 
more money than others. And when you run the numbers, when you 
consider that we have got 320 million people, really 330 
million people, so 10 percent of that is 33 million people. And 
we got a $21 trillion dollar--that is 12 zeros--GDP (gross 
domestic product), and we spend 18 percent of that on GDP and 
you take two-thirds of that 18 percent and then you divide it 
by 33 million. What you come out with is $80,000 a person. So 
for these 33 million people out of 333 million, we are spending 
about $80,000 a person.
    Why can we not identify those 33 million? I did not say 
$8,000. $80,000. I am going to land this plane on time, Mr. 
Chairman.
    [Laughter.]
    Senator Kennedy. Why can we not identify those people and 
with $80,000 a person manage their care better?
    Secretary Azar. You know what, Senator. In fact, we can and 
we can do that through vehicles like either invisible or 
visible reinsurance pools. For instance, even under the ACA, I 
have approved seven State reinsurance plans that have brought 
premiums down in those States by anywhere from 9 percent to 30 
percent by cleaving off the risk for those higher risk people 
and separately reinsuring that so that the burden is not borne 
by all the other healthier people in that pool. Absolutely.
    Senator Kennedy. Thank you, Mr. Chairman.
    Senator Blunt. Thank you, Senator.
    Senator Schatz.
    Senator Schatz. Thank you, Mr. Chairman, Ranking Member.
    Secretary, thank you for being here.

                           YOUTH TOBACCO USE

    I am worried about tobacco use among our young people, and 
that is why I am about to introduce the Tobacco to 21 Act with 
Senator Young. Our bill would raise the minimum age from 18 to 
21 for the purchase of tobacco products, and that includes the 
sale of combustible cigarettes and e-cigarettes. The Institute 
of Medicine has found that raising the tobacco age of sale to 
21 would reduce tobacco initiation especially among kids 15 to 
17. It would also lead to a 12 percent decrease in smoking 
prevalence. Nine States, including Hawaii and hundreds of 
localities have already taken this action.
    Do you agree that tobacco use among youth is a severe 
public health problem? And do you commit to me that we can work 
together on this legislation?
    Secretary Azar. Senator, thank you very much for that 
question, and thank you for your work in this area.
    Like you, I am extremely concerned about tobacco use and 
specifically the e-cigarette epidemic among our youth. I am 
committed to working with you and with other Members of 
Congress on legislation to address tobacco use among youth, as 
well as taking any necessary regulatory action.
    Commissioner Gottlieb--his last day is today--and I have 
been very clear that while e-cigarettes may offer a lower risk 
alternative for adult smokers who still want access to 
nicotine, we cannot allow e-cigarettes to be an on-ramp to 
combustible cigarette use or nicotine addiction for an entire 
new generation.
    FDA is proposing to prioritize enforcement of flavored e-
cigarettes that are offered for sale in ways that pose a 
greater risk for minors to access the products. For instance, 
FDA will consider whether the products are sold under 
circumstances without heightened age verification.
    And while we pursue changes to regulatory policy, we call 
on the industry, manufacturers, and retailers, to step up with 
meaningful measures to reduce the access and appeal of e-
cigarettes to young people. The epidemic level rise in youth e-
cigarette use has also prompted a series of escalating actions 
by the FDA in both enforcement and public education.
    So thank you very much, sir, for your help, and I look 
forward to working with you on this.
    Senator Schatz. Thank you.

                               TELEHEALTH

    Let us move to telehealth. I know you are a big supporter 
of telehealth and that you have noted that the regulatory and 
payment barriers can limit telehealth services. One section of 
the Connect for Health Act would give you the authority to 
waive barriers to traditional Medicare reimbursement under two 
circumstances, if the telehealth services would reduce spending 
while maintaining quality or if the telehealth services would 
improve healthcare quality without increasing spending.
    Can you talk about what that waiver authority would mean in 
terms of public health and especially expenditures regarding 
public health?
    Secretary Azar. So as you mentioned, I have been passionate 
in my advocacy of telehealth. I think it is vitally important 
for States like Hawaii, for States that are rural for expanding 
access to care and also for expanding just the quality of care 
even where we have care delivery and to make sure that all of 
America shares in centers of excellence through telehealth.
    The Social Security Act, unfortunately, was written in the 
1960s before telehealth existed. And so there are many barriers 
to that. And I look forward to working with you on any ways in 
which greater flexibility could appropriately be brought to me 
especially in ways that do not open the door to fraud, abuse, 
or of course, waste of precious taxpayer beneficiary resources.
    Senator Schatz. We got a lot done with Senator Hatch's 
leadership and with a big bipartisan group on telehealth. There 
are a few more things to do. This is not the only one. But the 
waiver authority is sort of the holy grail. So for the members, 
we really got to get this done.
    Secretary Azar. I hope perhaps this could be included in 
the work that Senator Murray and Senator Alexander are leading 
on cost work.
    Senator Schatz. Yes.

                      UNACCOMPANIED ALIEN CHILDREN

    And then just a final comment and question. I was struck by 
the exchange between Senator Merkley and you in one particular 
way. Obviously, it got contentious because this is, frankly, 
the kind of thing that should cause people to be emotional.
    But to the extent that there is a statute that provides for 
confidentiality for potential sponsors but in the moment where 
a decision is being made, sponsors are not aware of that 
statute, that seems to me to be a light bulb going off for all 
of us, that we need to do a better job of communicating to 
sponsors that their confidentiality is protected, that their 
family situation is protected, and that we in fact, as a matter 
of government policy, whatever we think about the border wall, 
whatever we think about whose fault is what and what we ought 
to consular offices and all these other arguments, that at a 
minimum these kids need sponsors. And to the extent that 
potential sponsors are afraid to do so because they are afraid 
they are going to end up in some database, we need to do a 
better job of telling them that there is a law that protects 
their confidentiality. And I am hoping we can work together to 
follow up on that.
    Secretary Azar. Thank you. Of course.
    Senator Schatz. Thank you very much.
    Senator Blunt. Thank you, Senator Schatz.
    Senator Hyde-Smith.
    Senator Hyde-Smith. Thank you, Mr. Chairman.
    And I certainly appreciate Secretary Azar being here today 
and answering the questions the way that you are doing this.

                            RURAL HOSPITALS

    I am, obviously, the Senator from Mississippi. And we have 
so many rural hospitals in Mississippi that are really 
struggling. A recent report found that half of all rural 
hospitals in Mississippi are at high financial risk of closing. 
I just read an article that Mississippi has more rural 
hospitals at risk of closing than any other State in this 
country.
    When a hospital closes, obviously the whole community is 
affected in so many ways, not only the employment there but 
mainly--and what is most important--it means no more access to 
emergency care for the community's residents. In an emergency, 
timely care is of essence, and having close-by access to them 
can truly mean life or death. We just recently had a young lady 
in Mississippi just a few weeks ago that died of an asthma 
attack.
    So I guess my question is, what is HHS doing to respond to 
these rural hospital closures that is very critical in my 
State?
    Secretary Azar. Well, thank you. You have repeatedly raised 
with me the concerns about rural hospital access in 
Mississippi, and in part because of your efforts, I have 
created a task force across HHS to help come up with all ideas 
that we can around how we can help address the hospital crisis. 
Let me give you some ideas.
    One of them we just were discussing, which is telehealth. 
How can we help make sure that we are expanding access into 
rural America? Because we will end up consolidating everyone 
living in urban areas if we cannot provide them healthcare in 
rural America. So telehealth is important.
    We have to make sure that providers are able to practice to 
the maximum of their licensure so that we are not having 
artificial restraints on trade and competition that are 
blocking access in rural America.
    And we also have to make sure that our regulations at CMS 
or otherwise are not creating artificial barriers to 
economically viable models of hospitals in rural America. Are 
we trying to force the 1960s model of hospitals through our 
payment systems and other regulations onto rural America? So we 
are looking at how do we even re-conceive the needs of rural 
America from a hospital perspective.
    You said ER, for instance. I was talking with the leader of 
a critical access hospital yesterday. I learned about a 
requirement that we have which is that to be a CAH (Critical 
Access Hospital), you have to have a surgeon on staff who might 
do 20 surgeries a year. One has to ask, does that requirement 
still hold in the modern era, and is that part of making that 
facility economically viable long-term to be able to provide 
access in that community?
    So this is a deep passion of mine. We are working on this. 
Any ideas you have of things we can do to be helpful, certainly 
we want to be there.
    Senator Hyde-Smith. Thank you very much.
    Senator Blunt. Thank you, Senator.
    Senator Baldwin.
    Senator Baldwin. Thank you, Mr. Chairman.

                          AFFORDABLE CARE ACT

    Secretary Azar, I want to tell you about Zoe from Seymour, 
Wisconsin. Zoe was born with a congenital heart defect, and she 
had actually open heart surgery at 5 days old. She will be able 
to continue to get coverage and the care that she needs, thanks 
to the Affordable Care Act and its protections for people with 
preexisting health conditions.
    When the Republicans were working to repeal the Affordable 
Care Act legislatively, I got a letter from Zoe's mom, Chelsea. 
And Chelsea wrote to me and she said to me it is like they 
taking the American dream from her, referring to her daughter 
Zoe. She wrote, I am pleading with you as a mother to fight for 
those with preexisting conditions. Kids in Wisconsin with 
preexisting conditions are counting on you to protect that 
right.
    The administration, your administration, recently decided 
to support a lawsuit aimed at striking down the Affordable Care 
Act in its entirety and all of its protections.
    So how do I explain a decision like that to Zoe and her 
mom? Zoe, by the way, just celebrated her sixth birthday. And 
this is more or less a rhetorical question because I have some 
specifics. But how do you tell a little girl like that what is 
going to happen to her?
    So I want to just confirm my understanding that if the 
Affordable Care Act is struck down in its entirety in court, a 
position your administration is supporting, what protections 
preventing insurance companies from discriminating against 
those with preexisting conditions will still remain in law, if 
it is struck down?
    Secretary Azar. So, of course, there are the existing ERISA 
(Employee Retirement Income Security Act) protections and HIPAA 
(Health Insurance Portability and Accountability Act) 
protections around preexisting conditions that would not be 
impacted by that for those of us----
    Senator Baldwin. But the marketplace insurance----
    Secretary Azar [continuing]. Employer-sponsored insurance. 
And then as I was mentioning with Ranking Member Murray, we 
will be working then with Congress to ensure that any new 
better care has protection for preexisting conditions.
    Senator Baldwin. So in other words, if it is struck down, 
for a time there will be nothing in place to protect Zoe and 
kids like her.
    The truth is that there is not a plan right now to protect 
Zoe or people like her with preexisting conditions, and not 
only would this lawsuit take away these protections, but 
President Trump has broken his promise by expanding the use of 
junk health plans. That is what I call them because they do not 
have to cover preexisting conditions.
    And I just want to share a couple of examples in Wisconsin.
    One of the plans currently available in Wisconsin from 
Companion Life--the very first sentence of their policy states, 
``preexisting conditions diagnosed within the 60-month period 
immediately preceding such covered person's effective date are 
excluded for the first 12 months of coverage.''
    Another plan sold in Wisconsin now says, ``no benefits are 
payable for expenses for a preexisting condition described as a 
condition that, would have caused an ordinarily prudent person 
to seek medical advice, diagnosis, care, or treatment within 12 
months immediately preceding the date of coverage.''
    So explain to me how this decision not only to join this 
lawsuit to try to totally repeal and overturn the Affordable 
Care Act but this decision to proactively expand the use and 
availability of these junk plans is not a broken promise to 
protect people with preexisting conditions.
    Secretary Azar. So I assume you are referring to the short-
term limited duration plans which we restored to use as the 
Obama administration had. These plans are not for everyone. And 
if a plan like that--and I am quite glad that the consumer 
disclosure--enhanced consumer disclosures that we have are 
making it so apparent that if you had a preexisting condition, 
those would not be plans that you should choose. You would very 
well want to be getting an exchange-based plan that would cover 
your preexisting conditions or a short-term----
    Senator Baldwin. Well, but you are arguing----
    Secretary Azar [continuing]. That does cover preexisting 
conditions.
    Senator Baldwin [continuing]. In court to overturn the 
Affordable Care Act. So there will not be a marketplace.

                              DRUG PRICING

    Now I want to move on to something that you and I have 
discussed at length, which is drug prices. If the 
administration is successful in the lawsuit and the Affordable 
Care Act is struck down, the law's prescription drug price 
reforms would also be gone.
    Secretary Azar, your own Medicare prescription drug price 
proposal would be wiped out, and that is because your own pilot 
program is being tested through the Center for Medicare and 
Medicaid Innovation, CMMI, which was created under the 
Affordable Care Act. So yes or no, Secretary Azar. If the 
lawsuit succeeds and the Affordable Care Act is struck down in 
court, CMMI will cease to exist and so will this pilot. Is that 
true or false?
    Secretary Azar. There are a great deal of ifs in there. But 
CMMI is part of the Affordable Care Act, and my hope would be 
that any better care system we set up would similarly give me 
authorities to do demonstrations and pilots such as the one 
that we are firmly committed to there----
    Senator Baldwin. So it would cease to exist.
    Secretary Azar. We would have to find additional authority.
    Senator Blunt. Thank you, Senator.
    Senator Capito.
    Senator Capito. Thank you, Mr. Chairman.
    Thank you, Mr. Secretary, for being here.

                              OPIOIDS/HIV

    My first question from the State of West Virginia--Senator 
Manchin--we are both lucky enough to be on this subcommittee--
have been ravaged by the opioid epidemic. But we are starting 
to look at some of the ripple effects. And I know that you in 
your statement addressed the increase of hep C and B and also 
HIV.
    Could you just tell me just briefly how you are meeting 
those challenges working with our public health officials in 
our State? Some of them I think have been very forward leaning 
in trying to master this.
    Secretary Azar. Absolutely. So first off, the ending HIV 
epidemic will be very helpful with the additional funding and 
the focused efforts there. We see 10 percent of new HIV cases 
are coming out of injectable drug use. And so the efforts there 
where we hope we will actually completely stop the spread of 
HIV in this country would tackle that.
    In addition, we have special funding as part of the budget 
in the opioid initiative that we have requested to help with 
HIV spread and hep C infectious disease spread connected to the 
opioid problem that we have in the country.
    Senator Capito. Well, in my conversations with the head of 
the CDC just recently, he did tell me that with the new 
availability of different metrics that you are able to identify 
clusters quicker and be more effective with that. So that is 
very important to us.

                            CHILDHOOD CANCER

    I am going to shift to another issue that I am very 
passionate about, and that is Senator Reed and I--he is a 
member of the subcommittee as well--worked together to pass the 
STAR Act, which is the Childhood Cancer Survivorship, 
Treatment, Access, and Research. We got $30 million in the 
budget for that. I would like to know what your Department is 
doing on that and where you think it will lead to.
    Secretary Azar. Well, first, thank you for your support of 
the STAR Act and getting that passed.
    We have already begun implementation at the National Cancer 
Institute of the NCI-specific sections there.
    One of the most important parts here is enhancing the 
biospecimen collection and biorepositories that really aid us 
in the research programs needed to focus on pediatric cancer. 
That is vital to just building the evidence base and 
information we need. And also to conduct and support childhood 
cancer survivorship research efforts.
    At CDC, we are working to implement the CDC cancer 
registries there. So we look forward to their continued 
successful early case capture program that lets us identify 
children right away. So that also helps us with the research 
programs by getting that type of information and making that 
available.
    Senator Capito. So does the budget reflect next year a 
continuation of that funding?
    Secretary Azar. So, as you know, our budget proposes an 
additional $50 million to NIH for the pediatric cancer research 
program as part of a $500 million 10-year program with a focus 
on pediatric cancer research. You know, pediatric cancer has 
been neglected for a long time.
    Senator Capito. Right. I know that.
    Secretary Azar. And thanks to the STAR Act, thanks to the 
President's initiative here on pediatric cancer, I hope we will 
get a greater focus there.
    Senator Capito. I hope so too. Some of our leading 
hospitals, research hospitals, in our State are putting a great 
focus on this.

                           MATERNAL MORTALITY

    Lastly, I would like to ask you another thing. A statistic 
that I found rather surprising because I do not think we think 
of ourselves like this as a country, but the rising statistics 
of maternal mortality. And I think you are quoted in your 
statement as saying over 700 women died in and around 
associated with childbirth. We did pass with a bipartisan 
effort the Maternal Mortality Accountability Act for us to get 
good statistics on what is actually going on here because you 
state that these deaths are actually--many of them--very 
preventable.
    What steps is your Department taking to take charge of this 
issue?
    Secretary Azar. Well, as you mentioned, maternal mortality 
rates in the U.S. have more than doubled over the past few 
decades.
    Senator Capito. I mean, do you have any idea why?
    Secretary Azar. Well, so much of it is about prenatal care 
and labor and delivery care and access. You know, in rural 
America, we have a real labor and delivery crisis.
    Senator Capito. Yes.
    Secretary Azar. And associated that is appropriate prenatal 
care. And of course, the immigration crisis is bringing in so 
many individuals in terms of getting adequate prenatal and 
labor and delivery care also. I do not know the full 
demographic breakdown on that.
    But I appreciate, obviously, Senator Murray's leadership in 
this space also.
    Our budget proposes the $58 million for the Maternal 
Mortality Prevention and Surveillance at CDC, which you just 
mentioned. And that includes $12 million to support data 
collection and research to understand even better the causes of 
these deaths so we really can aim at the problem and then 
tailor solutions towards that.
    Senator Capito. Well, I think you will find both Senator 
Murray's leadership and others--you will have a very supportive 
Senate and probably Congress in this effort. Obviously, the 
President is supporting this as well. Thank you so much.
    Secretary Azar. Thank you.
    Senator Blunt. Thank you, Senator Capito.
    Senator Murphy.
    Senator Murphy. Thank you very much, Mr. Chairman.
    Thank you, Mr. Secretary, for being here today.
    I want to thank the Chairman and the ranking member for 
acknowledging at the outset what is the reality here. This 
budget is not going to be reflected in the one that Congress 
ultimately passes. We would never support the kind of draconian 
cuts that are in it to people in need, to very sick people, to 
very vulnerable populations. And so I understand that we are 
going to work together, Republicans and Democrats, to make sure 
that this budget never ever sees the light of day.
    But I think for the good of the order, it makes sense to 
repeat why this budget is so offensive to many of us. It is not 
just the cuts. It is that they stand in contrast to a giant 
gift-wrapped present that this Congress gave to the very, very 
wealthy in this country about a year ago, a $2 trillion unpaid-
for tax cut that was promised to increase wages by $4,000 per 
person. That simply has not done that. It, when fully 
implemented, will deliver 80 percent of the benefits to the top 
1 percent of income earners, and now we are seeing who is being 
asked to pay for it, frail seniors in Connecticut who are going 
to have their heating shut off in the winter because the Trump 
budget does not fund the Low-Income Heating Assistance Program. 
So I think that is at the heart of our frustration. It is not 
just that this budget does not reflect our values. It is that 
it stands in contrast with a tax cut that just is not going to 
deliver results for the majority of Americans.

                                OPIOIDS

    Mr. Secretary, I wanted to talk to you about the effect of 
this budget on the opioid epidemic. In your testimony, you 
point to about $5 billion in funding that is directly dedicated 
to the opioid epidemic. That is largely money that was already 
in the budget. But it stands in contrast to $1.5 trillion in 
Medicaid cuts in this budget, including the wholesale 
elimination of the Medicaid expansion. Four out of 10 non-
elderly adults that are dealing with opioid addiction today are 
on Medicaid. And so when you put $5 billion in essentially flat 
funding for specific opioid treatment next to $1.5 trillion in 
cuts to the insurance program that actually allows States to 
pay for treatment, the result is a devastating net negative, a 
dramatic contraction of Federal dollars out of the opioid 
treatment system.
    And I guess I just want to be honest what we are doing 
here. I know you may say, well, we are still going to spend 
more money in real dollars, but this is a $1.5 trillion cut 
compared to what we expected States to spend. And I feel like 
we should just be honest that what this budget asks is for 
States to pick up a much bigger share of the burden for caring 
for people with addiction and that this national emergency we 
declared comes with it an expectation that the Federal 
Government would do less and States will do more. Connecticut 
will try to scramble to come up with the money when we lose 
100,000 people off of the rolls of our Medicaid program. Other 
States may not be able to come up with those dollars.
    I just want to ask you that. Is this not what we are doing? 
Are we not just asking States to essentially pick up the burden 
of the opioid epidemic, given the comparison of the Medicaid 
cuts in this bill to the $5 billion in specific opioid funding?
    Secretary Azar. I do not think so. Well, you are right. We 
have a $1.5 trillion reduction that is in the budget for the 
Medicaid expansion and the Affordable Care Act exchange 
subsidies. We add back a $1.2 trillion program that would be 
State-based flexibility. My hope is that it would actually 
correct--one of the things I worry about with the opioid crisis 
and many other public health issues we deal with is that the 
Medicaid expansion, with its focus on able-bodied adults, has 
taken away from our--it has actually incentivized coverage 
there away from the aged, disabled, children, pregnant mothers, 
those for instance, opioid-addicted that are part of the core 
Medicaid.
    And my hope is that with the $1.2 trillion program and the 
complete flexibility for the States on that money, that they 
actually would focus that in areas like you just talked about 
where the needs are greatest and really prioritize in those 
areas. And it might actually enhance coverage and access for 
those individuals that we all care so much about.
    Senator Murphy. Yes. We have heard this for a long time, 
that flexibility will allow States to enhance and greater focus 
their coverage, but in the end, it is a whole lot less money 
than they were getting today. And States are begging for 
additional dollars to care for people with the opioid epidemic. 
Asking them to just focus better with less money I just think 
ignores the feedback that all of us are getting, Republicans 
and Democrats, about the realities on the ground.
    Thank you, Mr. Chairman.
    Senator Blunt. Thank you, Senator.
    Senator Manchin, followed by Senator Shaheen. Senator 
Manchin.
    Senator Manchin. Thank you, Mr. Chairman. I appreciate it.
    And thank you, Secretary, first of all, for being here and 
also for your service.

                                OPIOIDS

    You and I have talked briefly. I am asking for the help 
that we need in our little State of West Virginia. We face the 
largest per capita economic burden in the country, and I think 
my dear friend, Senator Shaheen, is right behind us on this. 
The epidemic of opioids is costing our economy in our little 
State $8.89 billion a year and forcing us to dedicate the 
largest share of GDP of any State to costs related to the 
crisis, which is 12 percent.
    I appreciate what you all have done. And everybody is 
concerned about the cutting. I think we will work through this. 
Okay.
    But the 15 percent set-aside that you have for hard-hit 
States I am asking, through your rules and regulations, if you 
can do this. You have to take in consideration the deaths per 
capita not just the total deaths. I got counties that this is 
enormous. But if you look at the total deaths and offsetting 
the 15 percent, we cannot help them that much. Does that make 
sense?
    Secretary Azar. There is a lot of sense to that, and I 
appreciate your raising that issue. One thing would be where--
and you all helped us a lot with not just the SUPPORT Act but 
with your appropriations funding on opioids with helping us 
with the formulas to allow a focus of money on the highest 
burden States. If that issue of deaths versus incidence per 
capita is in there, obviously I need you to fix that.
    Senator Manchin. We can fix it. If not, if you can----
    Secretary Azar. And there may be some allocation issues 
within the States, for instance, rural versus urban within the 
State. I am happy to work with you and the government in West 
Virginia to educate and focus on that area.
    Senator Manchin. I have two very quick ones and my final 
comment.
    The Jessie's Law. We talked about that. And you might want 
to expand on what can be done and how quickly you can make this 
happen. I know there is some hoops that we have to draw 
through, but all of us have agreed that Jessie's Law is 
something that is extremely needed and it can save lives. And 
it is so simple, but yet we are running into so many 
complications as far as privacy, HIPAA, and all these other 
things. Can you just briefly state----
    Secretary Azar. Absolutely. And thank you for prioritizing 
the work in this area. I am going to be speaking with our head 
of the Office of National Coordinator, as well as SAMHSA 
(Substance Abuse and Mental Health Services Administration), to 
make sure it is a priority to share these best practices that 
are part of the Jessie's Law that are in the SUPPORT Act.
    We do have to examine issues like 42 CFR, part 2 to make 
sure that there are not unintended consequences, for instance, 
where providers do not put information about somebody's 
addiction status in the electronic medical record for fear of 
additional regulatory complications there. And so we need to 
work on that and make sure that is not standing in the way of 
appropriate care and treatment because what happened to Jessie 
should not happen.
    Senator Manchin. Absolutely. You understand it, and I 
appreciate your diligence towards that because it just means so 
much to all of us.
    Very quickly. Funding for this horrible, horrible disease 
of addiction. I have introduced LifeBOAT year after year after 
year. LifeBOAT basically says that all pharmaceuticals that are 
producing opiates should pay 1 penny per milligram for 
production fees. That would give us the permanent funding. I 
know it is a tough one. It is a heavy lift for some of my 
friends. I am not looking at that as a tax. If you want to make 
this product, if you think we need all these products, then you 
ought to pay a production fee to make sure that we have a 
constant stream of money. This goes to the areas that are hit 
the hardest. It will not put anybody out of business.
    Secretary Azar. The genesis of this crisis were the legal 
opioids, and that is why I am so glad that we have gotten legal 
opioid prescribing down by 20 percent. And I think the MME, the 
morphine----
    Senator Manchin. If you can talk to the President on this 
one, this would be a great LifeBOAT Act. 1 penny per milligram 
would be a tremendous help.

                          AFFORDABLE CARE ACT

    Finally on the Affordable Care Act, the President says he 
is not going to do anything till after 2020. So we are going to 
have it depending on what the courts do. Let us say the court 
kind of abdicate from this and we still have it. You have a lot 
of expertise and you bring an awful lot to the table. How would 
you fix what you have in front of you if that is all you had, 
nothing new, not reinventing the wheel? I was not here in 2000. 
I would have been hard-pressed to vote for what was in front of 
me. I would have worked like heck to change a few things, but 
what we have is integrated into our system, one-sixth of our 
economy. How would you recommend to fixing?
    Secretary Azar. I believe there are tremendous deep 
problems in the ACA in just how the insurance benefit is 
structured there, issues around--I will give you one example 
which is the 3 to 1 rating. Essentially, you have made 
insurance for individuals who are healthy and young, 
unaffordable and they walk from the market. And that created 
this kind of downward spiral that we have seen.
    Senator Manchin. Got you. You are saying because we are 
preventing higher than a 3 to 1 rate on the people that are 
very sick.
    Secretary Azar. Right.
    Senator Manchin. But that is where we get into it. Our 
differences with our Republican friends--they cannot come up 
with how do you protect preexisting conditions. You can say, 
oh, yes, we are going to make it illegal for anyone, any 
insurance company not to sell. And by definition you said they 
cannot deny your preexisting condition. You can charge us out 
of the market that I cannot afford or my aunt cannot afford, 
and it will break the family and they go without because back 
home in West Virginia, they will say I do not want to be a 
burden to my family. That means they cannot afford what is out 
there.
    You are preventing them from being denied. You are not 
preventing from being able to afford it.
    Secretary Azar. Right. And there are ways that one can 
actually make sure that insurance for people with preexisting 
conditions is affordable. Senator Kennedy and I had a bit of a 
discussion earlier about that, about reinsurance vehicles that 
are actually quite well established and work very well.
    Senator Manchin. We have a bill called--it was the Collins-
Nelson, and I am going to be introducing that with Susan now 
since Bill is not here. And we would love to have your support 
on that because we think that would be a big fix and reducing 
from the private pay. It could reduce anywhere from 20 to 40 
percent overnight.
    Secretary Azar. We would be happy to work with you on that, 
especially if we could do that in conjunction, as we had 
before, with what was going to be the Alexander-Murray-Collins-
Nelson package that would have CSR (cost-sharing reduction) 
funding attached to that.
    Senator Manchin. Those two bills have been laying on the 
Majority Leader McConnell's desk for close to 2 years.
    Secretary Azar. We would be happy to work with you on 
those.
    Of course, I think where we have got a stumbling block, 
Senator Murray, was around ensuring that the funding on the 
CSRs would have appropriate Hyde Act protections, and that 
ended up I think being the stumbling block for us at the end of 
the day there.
    Senator Manchin. I am sure she would like----
    Senator Blunt. Thank you, Senator. If you want to stay for 
a minute, there will be time for more questions if you have 
more to ask.
    Senator Shaheen.
    Senator Shaheen. Well, thank you, Mr. Secretary, for being 
here.

                          AFFORDABLE CARE ACT

    I would say that there was actually an agreement between 
both sides on the Alexander-Murray legislation and a strong 
list of bipartisan sponsors, and it is unfortunate that because 
there was opposition from the White House, because there was 
opposition from the leadership in the Senate, that bill was not 
able to come to the floor. And I would encourage you. I think 
everybody who has been in the Senate since we passed the 
Affordable Care Act recognizes that we need to improve some 
things that some things are not working.
    But the response is not to refuse to come to the table. It 
is not to overturn the law so that people have no alternatives. 
The answer is to work together to get it done. And I am very 
disappointed that we have not seen that kind of leadership 
either from the Senate leadership or from the White House. So I 
hope you will share your views that you think there are things 
we could do together because so far that has been missing from 
the conversation.

                                OPIOIDS

    I want to agree with Senator Manchin of the importance of 
the set-aside on the opioid funding. It has been critical in a 
State like New Hampshire where, as you know because you are 
familiar with it, we have a huge problem. We are behind West 
Virginia in terms of the overdose death rate, but way too high 
for our State. We have way too many families who are affected, 
and the pain is--you cannot talk to anybody in New Hampshire 
who does not know someone or has not been affected personally 
by this epidemic.
    And those set-aside dollars that have been used for the 
State opioid response grants have made a huge difference in New 
Hampshire. It has allowed us to set up a hub and spoke system 
that keeps people within an hour from a place where they can 
get treatment, which has been very important. We are still 
waiting to see exactly how this is going to work, but it is an 
improvement and something that would not have been done without 
those dollars.
    We had a hearing here a couple of weeks ago--and I was 
talking to you about it at the start of this hearing--where 
there were people from States across this country who were 
directors of programs to respond to the opioid epidemic. And I 
asked them all a question. One was from New Hampshire. She 
heads a recovery center. I said what happens if these Federal 
dollars go away. And she said, well, I will go back to bake 
sales. Some of the other folks were a lot more direct. They 
said people will die.
    In New Hampshire, the expansion of Medicaid has been one of 
the things that has been most critical to ensuring that people 
can get treatment and that we can prevent some of those deaths. 
And yet, I share the concerns that Senator Murphy was raising 
about what this budget does to repeal the Medicaid expansion 
and replace it with block grants because not only does it cut 
the amount available to States, but it assumes then every State 
is going to come up with the funding to replace that. And I 
think that is a huge question in a lot of the country.
    So can you talk about what we should say to those people 
who are running the programs to address the opioid epidemic 
about what they should do if these Federal dollars go away?
    Secretary Azar. Well, I appreciate your concern. The 
President is adamant. Our budget reflects this about the 
funding and support for the opioid epidemic and the work that 
we have together. And we want to keep working with you to 
ensure the States that have the highest burden are getting the 
share of resources that they need to deal with this.
    In addition, our budget proposes with Medicaid that we 
would actually expand access for women postpartum for 1 year, 
to have eligibility postpartum, who are suffering from 
addictions. That is one of the changes we have got in the 
budget. We continue to process the IMD exclusion waivers to 
ensure that we have inpatient capacity and expanded capacity 
for inpatient in communities. So we are continuing to drive 
forward fully engaged, fully focused around the opioid 
epidemic. We are seeing the results. We targeted the State 
opioid response grants actually to ensure access to medication-
assisted treatment, you know, the gold standard. And I think we 
are helping to really just expand capacity by making it quite 
clear that this is the most evidence-based approach to people 
for treatment and lifelong recovery.
    Senator Shaheen. Well, I appreciate those changes. I think 
they are very important. But if the fundamental funding source 
and coverage source for people to get treatment goes away, then 
those will make a small difference but they will not address 
the underlying problem.
    Can I ask one more question, Mr. Chairman?

                              DRUG PRICING

    Yesterday, a study from the Kaiser Family Foundation found 
that Medicare Part D spending on insulin grew by 840 percent 
between 2007 and 2017. As you know, diabetes is one of the most 
expensive chronic illnesses we have in this country, and 
figuring out how to help patients with the cost of insulin at 
the pharmacy counter is very critical. But it is also a 
question about how can we be most effective with our public 
dollars to address illness.
    So I know that your Department has proposed new rules to 
limit the impact of pharmacy benefit manager rebates that have 
helped to drive up the cost of Part D drugs. Can you tell us 
whether you think removing that link is going to help address 
things like those insulin costs, or do we need to be doing 
something else?
    Secretary Azar. Well, I would defer on the something else 
side. But I can tell you that the rule that we have proposed to 
get these rebates out of the system and instead have those go 
as discounts to the patient at the pharmacy level would be 
revolutionary for the patients in the situation you are talking 
about, especially classes like insulins or arthritis medicines 
or high-cost cholesterol medicines that are very highly rebated 
now. You might have in some of those classes, average 70 
percent rebates.
    Imagine January 1 of 2020. When that patient walks in the 
pharmacy, if this rule goes forward, they will get a 70 percent 
discount every time they fill that prescription. It is a 
revolutionary change for patient access and affordability if we 
can get this through. And I pray that we will have your support 
to help do that. It is $29 billion of rebates that are going to 
the pharmacy benefit managers now that would go to patients 
starting January 1, 2020 if we can make this happen.
    Senator Shaheen. Well, I look forward to hearing more about 
it. Thank you.
    Senator Blunt. Senator Murray.
    Senator Murray. Thank you very much, Mr. Chairman. And 
thank you for allowing us to ask one more question.

                      UNACCOMPANIED ALIEN CHILDREN

    Mr. Secretary, I did want to express my serious concerns 
about what is going on in the unaccompanied children program. 
Most shelters, as you know, are working to provide excellent 
care to this very vulnerable population. HHS, as you know, is 
charged with the welfare of every child in its care, and I am 
deeply troubled by some of the reports of forced drugging, 
sexual abuse, and substandard conditions at some of the 
temporary facilities. And I was especially appalled by the 
great lengths that former ORR (Office of Refugee Resettlement) 
Director Scott Lloyd went to prevent minors in ORR custody from 
accessing reproductive care, including cases where pregnancies 
were the result of sexual assault.
    And despite the fact that a Federal judge issued an 
injunction in March of 2018, barring ORR from obstructing 
access to abortion, a recently released spreadsheet shows that 
ORR continued to track minors' private reproductive health 
information through June 2018. And there is no indication that 
the information collected in that spreadsheet is being used to 
ensure access to reproductive care.
    I wanted to ask you, does ORR still keep a spreadsheet 
containing the reproductive health information of pregnant 
minors?
    Secretary Azar. I am not aware of any centralized 
spreadsheet. I could not answer for him, but I believe the 
intention--this was the last menstrual period date, which of 
course for any of us who have had children know is vital to 
prenatal care, just to know gestational age of the child, not 
ongoing cycle information or otherwise. And that is my 
understanding. I am not aware whether there would be--and I 
doubt there is any type of central repository.
    We have actually ensured now the delegation from the ORR 
Director of all decisions on significant medical procedures for 
our unaccompanied alien children to the ORR career staff. And I 
believe we are fully compliant with the court's order and 
injunction and faithfully executing on that.
    Senator Murray. Well, what are you doing to make sure that 
ORR complies with the court order?
    Secretary Azar. I have and always will make clear that when 
there is a court order in place, we are to faithfully apply 
that. And so the order that you are referring to--I believe 
that we are in full compliance with it. If we are not, I would 
like to know. But I certainly would give instruction always 
that we should be in compliance with court orders.
    Senator Murray. When were you first aware that Director 
Lloyd was being regularly briefed on pregnant minors' health 
information and actually was personally contacting pregnant 
minors to discourage them from seeking abortions? Do you 
believe that is an appropriate role for the Director, and when 
did you know?
    Secretary Azar. I think you and I spoke about this actually 
during the confirmation process, if I remember correctly, back 
in my first hearing in early December, before I was in office. 
So I think probably this was an issue of some controversy even 
then--public controversy. So I think probably around then. 
Goodness. I cannot quite remember.
    The issue of a 12-year-old girl who was pregnant in our 
care--we are the custodian of that child, and we are delegated 
to make the serious medical decisions as the parent of that 
child, but in consultation, if we can, with the parents of that 
child.
    Senator Murray. This is really, important information. 
Senator Feinstein and I sent last week a letter to you asking 
you to have your staff brief us fully on what you were doing, 
where that information is, and how it is being used, and would 
like you to commit to having----
    Secretary Azar. We will certainly work with you on that. 
Absolutely.
    Senator Murray. Thank you.
    Senator Blunt. Thank you, Senator.
    I have two quick things. There will be more for the record, 
I am sure.

                           BEHAVIORAL HEALTH

    First, we are nearing the end of the 2-year pilot period of 
excellence in mental health. Our goal to come up with all the 
information we can about the impact of treating behavioral 
health like all other health and what is the impact on other 
health cost.
    So my request to you, as we talk about a 2-year extension 
to just get more information for States to look at in the 
future, it would be very helpful if you could commit to provide 
us any early CMS data before that program expires.
    Secretary Azar. I will work with the Administrator to get 
you any information. We have data to help support the analysis 
to support that legislative effort.
    Senator Blunt. You understand what I am saying. If you have 
got early data----
    Secretary Azar. Any data. Exactly.
    Senator Blunt [continuing]. To show one thing or another 
here, it would be helpful for us to say we believe this is 
where this is headed. And we would like to compile a little 
more information. The goal here again is to put the information 
out there that shows not only is this the right thing to do, 
which everybody already knows, but it is the fiscally smart 
thing to do as well.

                      UNACCOMPANIED ALIEN CHILDREN

    And my other question, on the sponsor criteria on the 
unaccompanied children that you talked about, who sets that 
sponsor criteria in terms of what the sponsor has to provide 
and how that is shared or not shared? Is that you or is that 
Homeland Security?
    Secretary Azar. So it would be statute as well as us. So 
the sponsorship criteria are set in the--I believe it is the 
Trafficking Victims Protection Act, largely the categories of 
category 1, 2, 3, and 4 sponsors. Our preference is always a 
category 1 sponsor, which would be a parent or guardian here in 
the United States already that we can place them with. Then 
category 2 would be our other relatives, aunts, uncles, 
brothers, sisters, that we would place them with. And then the 
3 would be more distant relatives that we could place.
    There are certain mandates in the statute, for instance, 
where there are various red flags. We have to do home visits 
and home inspections. We always have the right to and do do 
fingerprints and other biometric checking to confirm identify 
or to assist with background checking of any individuals. That, 
to my knowledge, has long been the case.
    We have had some heightened requirements, in part driven 
by--if you remember your colleague on the Permanent 
Subcommittee on Investigations did some work, Senator Portman 
and Senator Carper, on children who got placed with traffickers 
or ended up with traffickers in Ohio at the eggplant.
    So it is always a balance. We want to make sure we are 
balancing keeping children in congregate care as short a time 
as possible, but also making sure when they are placed out, we 
are placing them into a safe environment. And so we are always 
assessing any discretionary aspects of that balance to strike 
that. So we have required fingerprints at various times of all, 
say, household members for a level 2 sponsor.
    We decided in December that we were not seeing enough hits 
there in terms of information, added information that merited 
the delay from people coming in as these household members. And 
so we pulled back on that. We are always assessing what the 
needs are.
    Senator Blunt. I believe in your earlier response to 
Senator Merkley, you said you believed your direction from the 
Congress was that that information is not to be shared with the 
Immigration Service.
    Secretary Azar. No, no. If I could clarify. That 
information is shared with immigration services so that we can 
confirm identity, do background checking, and also get 
immigration status. We have long, previous administrations 
included, gotten immigration status. That is part of our 
placement decisions, not that they are precluded by being 
illegally in the country. We do not do that, but rather if 
somebody, for instance, is just about to be deported, they 
would not be an adequate long-term sponsor for someone. So we 
want to make sure of that information.
    Senator Blunt. If you find out someone is illegally in the 
country and not about to be deported, what do you do with that?
    Secretary Azar. If the person is within the categorization 
of sponsors and an appropriate sponsor from a child welfare 
perspective, we place the child. Most of our children are 
placed probably with individuals who are illegally in the 
country.
    That information at DHS--my understanding is that there is 
an appropriations rider that was passed as part of the large 
budget deal to end the closure of the government that actually 
restricts the use of that information over at DHS. But I would 
have to defer to DHS and its lawyers on that question.
    Senator Blunt. Thank you, Secretary.
    Senator Moran.
    Senator Moran. I will attempt to be brief, Mr. Chairman. 
Thank you for the second round.

                            LIVER ALLOCATION

    Mr. Secretary, I want to highlight--you and I would agree 
this is a significant issue affecting liver transplants. This 
policy has consequences and it is significant. That is true. 
Correct?
    Secretary Azar. Yes. The issue of liver transplants are 
very important to all of us. Absolutely.
    Senator Moran. And I got involved or interested in this 
topic after a conversation with a liver transplant program in 
my State. But as a result of that activity, I have been amazed 
at the number of people, individuals in Kansas and elsewhere, 
who come to me to talk about the importance of this liver 
transplant policy, people who have had a liver transplant, 
people who are waiting for a liver transplant, people who want 
to be on a list for a liver transplant.
    And again, you and I both would highlight and I would use 
this opportunity to highlight the importance of people being 
organ donors. We need more organs to meet the demands.
    But this is not just about the consequences to a particular 
transplant program. This issue has significant consequences, in 
fact, life and death consequences for people across the 
country.
    And finally, I would remind you that Senator Grassley, 
along with almost half the Senate, sent a letter to you, which 
I do not believe--at least I have not seen a response, and I 
would encourage you to respond.
    Secretary Azar. Thank you. And I do want you to know that I 
take that letter very seriously. It has my personal attention, 
and that is what prompted me to actually ensure that we went to 
OPTN and asked them to think again and to ensure the full 
consideration of the comments out of Kansas and Missouri 
providers. That was, even in spite of the computer glitch--and 
I understand the process here was bad in terms of the 
interactions with you. And on behalf of the Department, I 
apologize to you for any lack of courtesy and also just any 
problems in that process.
    My understanding is those comments, in spite of the 
computer glitch, were summarized to the OPTN board in their 
decisionmaking. So at least it was part--the summary was a part 
of the original decision-making and then presented in full to 
the liver committee later.
    I understand that is not necessarily everything you want to 
hear in terms of it would have been nice if they had been 
presented in full before any initial presumptive decision was 
made. That is why I went back and said please think again. 
Please, look at these comments. Look at these concerns. 
Obviously, I have got tremendous respect for every signatory on 
that letter.
    I hope if you do not have it, we will get it to you, the 
letter of response that I got. And if there are further avenues 
that are appropriate, legally justifiable to ensure appropriate 
process and consideration, I am most happy to consider them.
    Senator Moran. I have not been discourteously treated, but 
I failed to get the results I am looking for even when 
courteously treated. And it is results that I am looking for on 
behalf of folks who desperately need a liver transplant and 
other organs.
    Thank you.
    Senator Blunt. Thank you, Senator Moran.
    Thank you, Secretary Azar.

                     ADDITIONAL COMMITTEE QUESTIONS

    The record will stay open for 1 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
                                  acf
Family First Prevention Services Act Implementation
    Question. Please provide an update on ACFs implementation of the 
Family First Act, and specifically its evaluation of evidence-based 
programs newly eligible for funding under Family First for prevention 
related activities. When does ACF plan to include the first list of 
programs and models eligible for funding in the national clearinghouse? 
What challenges are ACF facing in timely evaluating programs and models 
for inclusion in the clearinghouse and how can Congress support ACFs 
work in this area?
    Answer. The Children's Bureau (CB) and the Office of Planning, 
Research and Evaluation (OPRE) have taken the opportunity, 
requirements, and timelines within the Family First Prevention Services 
Act (FFPSA) with regard to establishing the Title IV-E Prevention 
Services Clearinghouse (Clearinghouse) very seriously. Our goal has 
been, and remains, to review and rate as many services and programs as 
quickly as possible through the Clearinghouse to support States' 
efforts to improve outcomes for children and families through 
implementation of FFPSA.
    In November, CB released ACYF-CB-PI-18-09, which provides 
instructions on the requirements State title IV-E agencies must meet 
when electing the title IV-E prevention program. The Program 
Instruction includes a description of the HHS initial practice criteria 
and first list of services and programs selected for review as part of 
the Clearinghouse.
    The Clearinghouse has developed standards and procedures in 
accordance with the statutory requirements detailed in the FFPSA. The 
specific statutory requirements mean that these standards and 
procedures are unique, and do not precisely match those of any existing 
clearinghouse. The Clearinghouse will provide additional information, a 
more detailed description of the revised initial criteria, procedures 
for systematic review and re-review, and definitions of key terminology 
in the Prevention Services Clearinghouse Handbook of Standards and 
Procedures, which was published on April 26.
    We also released ratings for the first list of programs of services 
and will select additional programs and services for review later this 
summer.
    Below is a more comprehensive timeline of events that have occurred 
and estimated dates for the release of additional information:

------------------------------------------------------------------------
        EVENT              ESTIMATED DATE             DESCRIPTION
------------------------------------------------------------------------
ENACTMENT OF FFPSA         February 2, 2018   The President signed the
                                               Bipartisan Budget Act of
                                               2018, including FFPSA.
rrrrrrrrrrrrrrrrrrrrrr
PUBLICATION OF FRN            June 22, 2018   The CB published a FRN
                                               soliciting comments on
                                               the initial criteria and
                                               potential programs and
                                               services for review and
                                               inclusion in the
                                               Clearinghouse.
rrrrrrrrrrrrrrrrrrrrrr
CLOSE OF FRN COMMENT          July 22, 2018   The CB received and
 PERIOD                                        reviewed over 360 unique
                                               comments on the FRN.
rrrrrrrrrrrrrrrrrrrrrr
AWARD OF                     September 2018   The CB awarded the
 CLEARINGHOUSE                                 Clearinghouse contract to
 CONTRACT                                      Abt Associates.
rrrrrrrrrrrrrrrrrrrrrr
TITLE IV-E PREVENTION     November 30, 2018   The CB published program
 SERVICES PPROGRAM                             instructions on the title
 INSTRUCTION                                   IV-E prevention program
                                               for States and title IV-E
                                               Tribal agencies. The CB
                                               concurrently published
                                               program instructions on
                                               the kinship navigator
                                               program and the revised
                                               title IV-E financial
                                               reporting form.
rrrrrrrrrrrrrrrrrrrrrr
PREVENTION SERVICES             Spring 2019   Release of the Prevention
 CLEARINGHOUSE                                 Services Clearinghouse
 HANDBOOK OF                                   Handbook of Standards and
 STANDARDS AND                                 Procedures, which will
 PPROCEDURES                                   include (1) procedures
                                               for identifying programs
                                               and services and
                                               associated research
                                               studies for review or re-
                                               review, (2) standards for
                                               assessing the design,
                                               execution, and findings
                                               of research studies and
                                               rating programs and
                                               services, and (3)
                                               definitions of key terms.
rrrrrrrrrrrrrrrrrrrrrr
WEBINAR ADDRESSING              Spring 2019   The Clearinghouse project
 CLEARINGHOUSE                                 team will provide an
 STANDARDS AND                                 overview of the standards
 PROCEDURES                                    and procedures and answer
                                               questions about elements
                                               of review processes.
rrrrrrrrrrrrrrrrrrrrrr
PROGRAM AND SERVICE             Spring 2019   Release of the ratings of
 RATINGS                                       programs and services
                                               (may be rated as
                                               ``promising,''
                                               ``supported,'' ``well-
                                               supported,'' or ``does
                                               not currently meet
                                               criteria.'')
rrrrrrrrrrrrrrrrrrrrrr
NEXT PROGRAMS AND            August 8, 2019   Release of additional
 SERVICES TO BE                                programs and services
 REVIEWED                                      selected for systematic
                                               review.
------------------------------------------------------------------------


Challenges to the timely review of programs and services for inclusion 
        in the Clearinghouse:
  --The need to award and start-up a new contract to establish and 
        maintain the Clearinghouse's independent, systematic evidence 
        review. We explored all options for the most expeditious path 
        to awarding the contract, while complying with the requirements 
        of Federal contract law and policy;
  --The need to develop standards and procedures. There were key 
        differences between the statutory requirements of FFPSA and the 
        standards and procedures used by other clearinghouses;
  --Time to engage stakeholders and experts (both through the Federal 
        Register Notice and targeted outreach) to ensure the 
        Clearinghouse is relevant and responsive to the field expert 
        and stakeholder participants have given accolades to the Abt 
        Associates project team for their rapid progress establishing 
        the Clearinghouse; and
  --The large number of programs and services, across broad topical 
        areas, that might be considered for review.
  --The capacity of the Clearinghouse to review these services. FFPSA 
        provides a $1 million annual appropriation for the 
        Clearinghouse and other related technical assistance. The 2020 
        Budget proposed increasing this appropriation to $8 million 
        annually in order to better meet the needs of the Clearinghouse 
        and of States seeking technical assistance in implementing the 
        law.
Supporting Children and Families Affected by Substance Use Disorder
    Question. The fiscal year 2018 and fiscal year 2019 Labor/HHS 
appropriations bills each included $100 million in additional funding 
at ACF for supporting children and families affected by the opioid 
epidemic and substance use, including funding for implementing plans of 
infant safe care under CAPTA, Regional Partnership Grants, and Kinship 
Navigators. What is ACF doing to support parents and caregivers of all 
types affected by substance use, including helping keep families 
together successfully when appropriate? What guidance and technical 
assistance is HHS providing to States and local service providers, 
including making sure they're aware of funding opportunities, and new 
opportunities under Family First? What is ACF doing to help build the 
evidence-base of what works in supporting children and families 
affected by substance use, and how can Congress support these efforts?
    Answer. CB is committed to supporting children and families 
affected by the opioid epidemic in accordance with the current 
statutory structure for doing so. We are also committed to using 
technical assistance resources and tools to address the problems of 
opioid addiction and its impact on infants, children and families. With 
your partnership, we hope to continue and expand these effective 
programs. Thank you again for your interest and we hope that this 
overview of CB activities and programs to support children and families 
affected by substance misuse is responsive to your concerns.
Regional Partnership Grant Program
    The Regional Partnership Grant (RPG) program provides competitive 
grants that support collaborative partnerships between providers of 
child welfare services, substance use disorder treatment, and other 
family support services. Grantees are responsible for implementing 
regional partnerships aimed at improving the well-being, permanency, 
and safety outcomes of children who were in, or at risk of, out-of-home 
placement as a result of a parent's or caregiver's substance use 
disorder, including opioid use disorder. To comply with the 
requirements of the legislation and contribute knowledge to the fields 
of child welfare and substance use disorder treatment, all RPG grantees 
are required to conduct well-designed local evaluations and participate 
in the national cross-site evaluation. Grantees are required to 
identify and use appropriate evidence supported or emerging (evidence-
informed) programs or practices and encouraged to consider adapting 
these practices for their target populations if needed.
    In fiscal year 2018, ACF received $40 million for the RPG Program, 
including an additional $20 million appropriation above the authorized 
funding level. Funding went to provide continued support to the 17 5-
year RPG grants (in 17 States) that were awarded in September 2017. In 
addition, the funding supports the vital programmatic technical 
assistance (through the National Center on Substance Abuse and Child 
Welfare (NCSACW)) and the cross-site evaluation and evaluation 
technical assistance that supports the efforts of RPG grantees and 
allows the field to learn from their work. In September 2018, CB 
awarded an additional 10 RPG grants in 8 States for a 3-year period.
    In fiscal year 2019, ACF again received $40 million for the RPG 
Program, including an additional $20 million appropriation above the 
authorized funding level. Similar to the prior year, this funding goes 
to on-going support of previously awarded grants, as well as 
programmatic and evaluation technical assistance, and the cross-site 
evaluation. In November 2018, ACF posted a funding announcement for an 
anticipated 7 RPG projects.
Technical Assistance to States and Local Communities
    The NCSACW is one of the primary ways CB provides technical 
assistance to support to communities working to support families 
affected by substance use disorders. The mission of the NCSACW is to 
improve family recovery, safety and stability by advancing practices 
and collaboration among agencies, organizations and courts working with 
families affected by substance use and co-occurring mental health 
disorders and child abuse or neglect.
    NCSACW provides no-cost consultation, training, and technical 
assistance to child welfare agencies, substance use disorder treatment 
agencies, courts, and their allied systems including healthcare, and 
early childhood providers to improve outcomes for children and families 
affected by substance use disorders, including opioid use disorders. 
NCSACW's technical assistance helps these different systems come 
together to develop or enhance policies, practices, and procedures that 
benefit families. Technical assistance methods and strategies include 
phone, email or web based individualized consultation to provide 
information and resources; long term technical assistance programs; 
NCSACW Website, which hosts a variety of materials, publications and 
resources, including free online tutorials and a Child Welfare Training 
Toolkit aimed to improve knowledge and competencies on relevant and 
pressing issues of the field; and information dissemination through 
national webinars and conference presentations.
    For example, the NCSACW has implemented a specialized 18-24 month 
In-Depth Technical Assistance (IDTA) program focused on improving the 
safety, health, permanency in their relationships, and well-being of 
infants with prenatal substance exposure and the recovery of pregnant 
and parenting women and their families. States who are currently 
receiving IDTA include New York, North Carolina, Maryland, and West 
Virginia. It is anticipated that several new communities will be 
starting the IDTA program in the summer of 2019. For more information, 
please visit https://ncsacw.samhsa.gov/.
Plans of Safe Care
    The CB issued Program Instruction (PI) ACYF-CB-PI-18-06 on May 31, 
2018. Within that PI, CB notified States of the $60 million increase in 
the fiscal year 2018 appropriation for the Child Abuse Prevention and 
Treatment Act (CAPTA) State grant. The PI informed States that the 
funds were to be prioritized for the development, implementation and 
monitoring of plans of safe care for substance-exposed infants, 
consistent with the requirement found at 42 U.S.C. 5106a(b)(2)(B)(iii) 
(section 106(b)(2)(B)(iii) of CAPTA), as amended by the Comprehensive 
Addiction and Recovery Act of 2016 (CARA). The CB also directed States 
to include information on their plans for using the increased funding 
when submitting the Annual Progress and Services Report and CAPTA State 
Grant Annual Report that was due June 30, 2018.
    To provide technical assistance to support these implementation 
efforts by States, CB has provided technical assistance in several 
different ways. The CB has tasked the NCSACW to provide technical 
assistance related to CAPTA Plans of Safe Care on several different 
levels, including responding to technical assistance requests from 
States, creating technical assistance tools for States and communities 
to use, and supporting CB technical assistance efforts.
    On January 29-30, 2019, CB and its regional office in Region 9, 
with the support of the NCSACW, brought together State and county level 
teams from Arizona, California, and Nevada to attend a two day 
convening to advance the capacity of State and county capacity to 
improve the safety, permanency, recovery and well-being of infants with 
prenatal substance exposure and their families. State and county teams 
included representatives from child welfare, substance use treatment, 
court improvement projects, maternal and child health and others. 
Participant teams heard from experts from the field, other States 
sharing best practices, as well as engaging State and county teams, 
with technical assistance support from the NCSACW, to complete concrete 
action planning.
    In addition, in May 2018, the NCSCAW provided technical assistance 
for 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 in Regions 4, 
6 and 7. The convening provided all States with a similar knowledge 
base on pregnant and parenting women with substance use disorders and 
support the implementation of Plans of Safe Care, including issues 
related to identification, notification and monitoring of plans of safe 
care for infants affected by substance abuse. The sessions provided 
opportunities for peer-to-peer discussion on model programs, for 
information exchange among peers on States' efforts to implement plans 
of safe care, and to highlight resources available to States on these 
topics.
    CB Central and Regional Office staff have also conducted site 
visits to State child welfare agencies in New Jersey, Oregon, 
Louisiana, and Ohio in August and September 2018 to gain a greater 
understanding of the States' policies and practices related to their 
implementation of the CARA amendments to the CAPTA Plans of Safe Care. 
NCSACW staff also supported these site visits. Technical assistance 
needs were identified through this process, and resources were provided 
to States in follow-up. CB is currently in the process of planning 
several site visits to be completed in summer of 2019.
Kinship Navigator Program
    When parents struggle with opioid addiction and other substance use 
disorders, it is often grandparents and other relatives who take 
primary responsibility for the care of children in need of a safe and 
stable placement. Kinship navigator programs represent an important 
strategy to help grandparents and other kin caregivers to learn about 
and access programs and services to meet their own needs and the needs 
of the children they are raising.
    As you know, the FFPSA authorized the use of funding under title 
IV-E of the Social Security Act to support kinship navigator programs 
that meet criteria as a promising, supported or well- supported 
program. On November 30, 2018, the Children's Bureau issued guidance to 
States, territories and Tribes participating in the title IV-E program 
on the requirements for participating in the title IV-E Kinship 
Navigator Program. That guidance included information on the initial 
practice criteria being used to assess programs and identified two 
initial kinship navigator models identified for review by the Title IV-
E Prevention Services Clearinghouse.
    To prepare States, territories and Tribes to participate in that 
program, the Congress also appropriated funds under title IV-B of the 
Social Security in fiscal years 2018 and 2019 to be used to develop, 
expand or evaluate kinship navigator programs. Using the fiscal year 
2018 funds, HHS awarded $19 million to 57 State, territorial and Tribal 
title IV-E agencies in September 2018. The CB issued guidance on the 
actions required to apply for the fiscal year 2019 funding provided 
under title IV-B by the Appropriations Committee. The CB is currently 
reviewing the applications for funding received and expects to make 
awards later this fiscal year.
    In addition to the efforts described, the CB has in the past and 
will continue to provide information and technical assistance on new 
initiatives, funding opportunities, policy changes, other key 
information on these programs, through webinars, the maintenance of 
related listservs and other outreach activities.
                                  acl
Administration for Community Living
    Question. The budget includes cuts to the Developmental 
Disabilities Act programs for fiscal year 2020, including a 26 percent 
reduction for the State Councils on Developmental Disabilities and 9 
percent reduction to the Projects of National Significance. The 
Projects of National Significance funding supports data collection and 
funding for small, innovative projects that lead to best practices. How 
do these cuts compare to the reductions across ACL--are they 
commensurate? How would these cuts affect ACL's mission to maximize the 
independence, well-being, and health of people with disabilities across 
the lifespan?
    Answer. The overall requested Program Level is 7 percent below the 
fiscal year 2019 Enacted level. While every budget requires difficult 
decisions, the requested level prioritizes direct services for older 
adults and people with disabilities that help them to remain 
independent and participate fully in their communities. At the 
requested level, ACL will continue to work to maximize the 
independence, well-being, and health of people with disabilities across 
the lifespan.
Centers for Disease Control and Prevention
    Mr. Secretary, the budget takes unsustainable cuts to the Centers 
for Disease Control and Prevention. I'm particularly concerned about 
the 20 percent reduction to CDC chronic disease initiatives. While I 
support providing States with flexibility to allocate resources to best 
suit their needs, I am concerned that these cuts, combined with the 
elimination of the Preventive Health and Health Services Block Grant, 
will only reduce a States' ability to prevent diseases that make up the 
vast majority of our Nation's healthcare costs.
    Why did the Department cut important resources that go to States 
for some of the most critical chronic conditions like heart disease, 
stroke, and diabetes?
    Answer. In this constrained budget environment, difficult decisions 
had to be made across the Federal Government, including at CDC. The 
fiscal year 2020 President's Budget request for CDC focused resources 
on the highest priority public health activities.
    The fiscal year 2020 President's Budget carries forward the fiscal 
year 2019 President's Budget proposal to eliminate funding for the 
Preventive Health and Health Services Block Grant (PHHSBG). When the 
PHHSBG was first authorized in 1981, there were minimal resources 
within CDC's budget allocated for categorical programs such as heart 
disease, diabetes, immunizations, and obesity, and many States did not 
receive funding from CDC to support prevention of chronic disease.
    The Budget continues the proposal of the new 5-year block grant 
program, America's Health, which will provide flexibility to grantees 
and focus on the leading public health challenges faced by States, 
Tribes, localities, and territories.
  --With block grant funding, States and Tribes have the flexibility to 
        organize prevention and control efforts and deploy evidence-
        based interventions in a manner that makes the most sense to 
        their jurisdictions and circumstances.
  --Grantees could implement customized strategies to:
    --Improve the health and quality of life of people living with 
            heart disease, diabetes, obesity, and arthritis.
    --Help people manage and control their high blood pressure.
    --Help people who use tobacco to stop using and people who don't 
            use tobacco to stay tobacco-free.
    --Help people make sensible, healthy food and beverage choices 
            wherever they are.
    --Increase opportunities for people to be physically active at 
            home, at work, in communities, and throughout the day.
    CDC will continue to conduct critical science and provide health 
information that protects our Nation against health threats, and 
respond when these arise.
                                  nih
National Institutes of Health
    The fiscal year 2020 budget request reduces funding for the 
National Institutes of Health by $4.9 billion or 12.6 percent. I 
understand that your budget adheres to the budget cap level and that 
required significant reductions across the Department. NIH makes up 
nearly half of the Department's budget, so you had to make a difficult 
choice with this account. However, has the Department done any analysis 
to understand what the impact of these cuts would mean to medical 
research? How many grants would be reduced? What research programs 
would end? How many labs across the country would close? How many 
clinical trials would stop? Simply put, does the Department fully 
understand the impact this decision would have on the millions of 
Americans suffering from illness and the thousands of scientists trying 
to help them?
    Answer. NIH estimates that the number of new and competing Research 
Project Grants (RPGs) awarded would decrease from about 11,675 in 
fiscal year 2019 to 7,894 in fiscal year 2020. In addition, funding for 
noncompeting RPGs would be reduced; the size of the reduction to 
specific awards would depend on the Institute involved. Similar 
reductions to other types of research grants would also be expected. In 
general, NIH seeks to avoid reductions of a magnitude that would end 
programs or close labs, so that existing research activities can 
continue on a smaller scale or slower timeline.
  --Research Project Grants (RPGs).--The fiscal year 2020 President's 
        Budget would provide $18.6 billion for RPGs, which is $2.9 
        billion less than the fiscal year 2019 estimate. This amount 
        would fund 7,894 Competing RPGs, or 3,781 less than for the 
        fiscal year 2019 estimate. It would also support 28,760 
        Noncompeting RPGs, 1,268 more than the fiscal year 2019 
        estimate. In addition, the projected average cost for Competing 
        RPGs of approximately $472,000 would be 12.7 percent below the 
        fiscal year 2019 projected average cost of nearly $540,600.
  --Small Business Innovation Research/Small Business Technology 
        Transfer (SBIR/STTR).--The fiscal year 2020 President's Budget 
        would provide $921.1 million for SBIR/STTR program grants, 
        which is $163.0 million below the fiscal year 2019 estimate. 
        The minimum set-aside requirement of 3.65 percent is achieved 
        in fiscal year 2020.
  --Research Centers.--The fiscal year 2020 President's Budget would 
        provide $2,218.0 million for Research Centers, which is $470.2 
        million less than the fiscal year 2019 estimate. This amount 
        would fund 1,155 grants, 180 less than the fiscal year 2019 
        level.
  --Other Research.--The fiscal year 2020 President's Budget would 
        provide $2,209.7 million for this mechanism, which is $280.0 
        million less than the fiscal year 2019 estimate. This amount 
        would fund 6,244 grants, which is 752 less than the number of 
        awards projected for fiscal year 2019.
  --Training.--The fiscal year 2020 President's Budget would provide 
        $801.9 million for training, which is $87.1 million below the 
        fiscal year 2019 estimate. This amount would fund 14,992 Full-
        Time Trainee Positions (FTTPs), which is 1,674 fewer than 
        planned for fiscal year 2019.
                                  oash
HIV Initiative
    Question. Your ``Ending HIV'' initiative would dedicate $291 
million with the goal of reducing HIV infections by 75 percent in 5 
years and 90 percent in 10 years. Please provide a detailed description 
of how the Department identified that these resources would have this 
kind of impact on reducing infections over 10 years.
    What specific evidence can you point to that this type of 
initiative is effective in reducing HIV infections?
    It is my understanding that the fiscal year 2020 investment is a 
down payment on an initiative that will require additional resources in 
future years. What is your best estimate of resources needed over the 
next 5 years? Please provide your estimate by fiscal year and Operating 
Division.
    Answer. As was noted by HHS leadership in an editorial in the 
Journal of the American Medical Association (JAMA), scientific advances 
over the last four decades suggest that, theoretically, the HIV 
epidemic in this country could be ended quickly by expanding access to 
treatment to all persons with HIV and pre-exposure prophylaxis (PrEP) 
to all those at high risk. Accordingly, the Administration has 
developed a practical, achievable plan to focus on hotspots of HIV 
infection, both demographic and geographic. Lessons learned and 
effective strategies emanating from this initiative would ultimately be 
applied to profoundly reduce HIV incidence nationwide through Federal, 
State, and local health departments and nongovernmental organizations.
    The strategic initiative includes 4 pillars:
  --diagnose all individuals with HIV as early as possible after 
        infection;
  --treat HIV infection rapidly and effectively to achieve sustained 
        viral suppression;
  --prevent at-risk individuals from acquiring HIV infection, including 
        the use of pre- exposure prophylaxis (PrEP); and
  --rapidly detect and respond to emerging clusters of HIV infection to 
        further reduce new transmissions.\1\
---------------------------------------------------------------------------
    \1\ https://jamanetwork.com/journals/jama/fullarticle/2724455.
---------------------------------------------------------------------------
    The fiscal year 2020 budget request is part of a multi-year 
initiative focused on ending the HIV epidemic in America by 2030.
Opioids
    Question. Secretary Azar, this Subcommittee has worked in a bi-
partisan way to provide $3.8 billion in fiscal year 2019 to address the 
opioid epidemic. In fact, fiscal year 2020 will mark the fifth year 
that this Subcommittee has dedicated significant resources to address 
the epidemic. What data does HHS have to show that these funds are 
effective in solving this crisis?
  --Where should we prioritize future resources?
  --What programs are working and what programs are not?
    $1.5 billion is provided directly to States through a flexible 
grant so States can use funds as they see fit. Unfortunately, we 
continue to hear that States are not spending those funds in a timely 
manner. Does HHS know why this is the case? What can be done to 
increase the spending rates?
    Answer. As noted in the Department's 2018 Annual Report, dedicated 
efforts from the Federal Government to communities and individuals have 
begun to show promising signs: from 2016 to 2017, according to the HHS-
run National Survey on Drug Use and Health, the number of Americans 
initiating heroin use dropped significantly.
    From January 2017 through November 2018, there has been a 26 
percent decrease in total morphine milligram equivalents dispensed 
monthly by pharmacies; a 338 percent increase in naloxone 
prescriptions; a 22 percent increase in number of patients receiving 
buprenorphine, one form of medication-assisted treatment (MAT) for 
opioid addiction, per month; and a 47 percent increase in number of 
naltrexone prescriptions, another form of MAT, per month. In addition, 
HRSA-funded community health centers saw a 64 percent increase in MAT 
patients and 75 percent increase in MAT providers from 2016 to 2017; 
SAMHSA's Medication Assisted Treatment--Prescription Drug and Opioid 
Addiction program achieved a 62 percent abstinence rate at 6 month 
follow-up, exceeding its target rate.
    The Department is constantly evaluating its programs, and we look 
forward to working with Congress as it determines the best allocation 
of resources to fight the opioid epidemic.
    In regards to States spending down their grants, the Department 
proactively provides technical assistance and stands ready to help in 
any way possible.
                                 samhsa
Hair Testing
    Question. Secretary Azar, the last surface transportation bill (the 
FAST Act) mandated that HHS issue technical guidelines for the adoption 
of hair testing as a federally-accepted drug testing method by December 
4, 2016. This deadline is now more than 2 years overdue. What is the 
reason for the delay? Will you commit to expeditiously completing these 
guidelines?
    Answer. In August of 2015, the Substance Abuse and Mental Health 
Services Administration's (SAMHSA) Drug Testing Advisory Board (DTAB) 
recommended that SAMHSA pursue hair as an alternative testing specimen 
with the caveats that `` . . . performance standards that sufficiently 
address external contamination and hair color impact . . . '' be 
established before using hair as a specimen in Federal drug testing 
programs. In addition, Section 5402(b) of the Fixing America's Surface 
Transportation (FAST) Act, enacted on December 4, 2015, required HHS to 
``issue scientific and technical guidelines for hair testing as a 
method of detecting the use of a controlled substance for purposes of 
section 31306 of title 49, United States Code.''
    SAMHSA has critically examined the current state-of-the-science and 
technology concerning hair drug testing and the utility of hair as a 
specimen for use in Federal programs. During this process, SAMHSA 
consulted with subject matter experts including hair testing 
researchers; laboratory practitioners and laboratory directors; medical 
review officers (MROs); and toxicologists with expertise in workplace 
drug testing regulations, programs, technologies, specimens, policy and 
is currently completing several studies. As a result of this 
evaluation, SAMHSA identified a number of unresolved issues that 
currently may limit the feasibility of hair testing for federally 
regulated programs.
    Due to the complex scientific and legal issues associated with hair 
testing, it has taken longer than anticipated to develop the guidelines 
required by the FAST Act. HHS has developed a draft proposal of the 
Mandatory Guidelines for Federal Workplace Drug Testing using hair, 
which is in its final review stages. Once finalized, HHS plans to 
submit this proposal to the Office of Management and Budget (OMB) in 
the second quarter of 2019 for review.
                                 ______
                                 
               Questions Submitted by Senator Jerry Moran
Global Health Security Agenda
    Question. The ongoing Ebola outbreak and other infectious disease 
threats, such as Zika, and antibiotic resistance, help reinforce the 
importance of the Global Health Security Agenda (GHSA)--a growing 
partnership of over 64 nations and stakeholders to help create a world 
safe and secure from infectious disease threats. Across multiple 
agencies, including CDC, USAID, and NIH, $1 billion in GHSA funding 
between 2014 and 2019 has supported efforts to build global health 
capacity to effectively combat infectious diseases. As you may know, 
this pool of funding expires in 2019. Can you speak to the importance 
of GHSA funding and commit to work with the members of this committee 
to support this vital initiative?
    Protecting Americans through building the health security capacity 
globally is a core mission of the CDC. The fiscal year 2020 President's 
Budget request includes $100 million for CDC for global health 
security, which will help to build a sustainable platform as CDC 
transitions these activities from supplemental balances to base 
appropriations. These funds will allow CDC to continue targeted 
bilateral support to countries that are building critical public health 
capacity to detect and respond to global health threats, enhance 
regional cooperation on priority threats such as viral hemorrhagic 
fevers and respiratory diseases, address cross-cutting vulnerabilities 
such as access to diagnostic tests and laboratory reagents, and 
facilitate rapid deployment of technical support to address emerging 
public health challenges.
    The United States Government remains committed to the Global Health 
Security Agenda (GHSA) and CDC continues to be an active partner 
through the next phase, GHSA 2024. The focus of this next phase 
includes enhancing accountability for delivering on commitments, 
measuring progress, and increasing domestic support for health 
security, including through enhanced partnerships with the non-
governmental sector.
Early Career Researchers
    The researchers who develop new vaccines, diagnostics and 
therapeutics are a vital tool against emerging infectious diseases. The 
21st Century Cures Act provided the National Institutes of Health (NIH) 
with the means to launch the Next Generation Researchers Initiative. 
Can you explain what steps your institute is taking to support early 
career researchers? Should any additional steps be taken to ensure the 
U.S. has the scientific workforce necessary to meet the needs presented 
by emerging threats?
    Answer. New scientists and innovative ideas are vital to the health 
of the biomedical research enterprise, including efforts to develop 
diagnostics, therapeutics, and vaccines to address emerging infectious 
diseases. Consistent with the NIH-wide efforts under the Next 
Generation Researchers Initiative (NGRI), the National Institute of 
Allergy and Infectious Diseases (NIAID) has prioritized support for 
early-career researchers and has created special programs and used 
other funding approaches to ensure a robust biomedical research 
workforce for the future.
    When applications for NIH research grants are reviewed for 
scientific and technical merit, NIH prioritizes funding for early State 
investigators with meritorious scores. NIH established this policy to 
allow reviewers to evaluate new researchers in the context of the early 
stage of their career, when reviewers may expect fewer preliminary data 
and publications from such researchers. In addition, when NIAID sets 
its payline for investigator-initiated research grants, it typically 
sets a second, higher payline for grants supporting new investigators. 
As a result, the cut-off point for funding applications is higher for 
those seeking support for new investigators than for the general 
application pool, making it easier for promising new investigators with 
a shorter history of successful research to receive support from an 
award. In addition to this preferential payline for grants supporting 
new investigators, NIAID also uses ``select pay'' to fund applications 
that receive good evaluations but would not otherwise meet the funding 
payline. In this case, NIAID may select `high risk, high reward' or 
other high priority projects, including those to support early-career 
researchers, for funding. Early-career researchers can be supported by 
bridge awards as well. Bridge awards are designed to provide short-term 
support for scientists who fall just outside the funding limits. NIAID 
uses bridge awards to allow time for scientists to gather additional 
data in support of a revised funding application. Early-career 
researchers may particularly benefit from these types of support as 
they move from training to begin their independent research endeavors.
    NIH research training grants provide another important resource for 
young scientists transitioning to research independence. These training 
grants include National Research Service Award institutional research 
training grants and the research career ``K'' development awards. NIAID 
funds two ``K'' research career development transition awards to 
support early-stage investigators, the K22 and the K99. NIAID has 
recently expanded its K99 program to target physician-scientists, with 
the goal of improving the retention of these individuals in research- 
oriented careers. In addition, NIAID recently established its R25 
research education program to support educational activities that 
complement and enhance research training of early-stage investigators 
in NIAID mission areas including emerging infectious diseases.
    Lastly, NIAID is implementing a New Innovator Award Pilot Program. 
The NIAID Pilot Program would use a `high risk, high reward' funding 
mechanism to support applications addressing NIAID research areas, 
including biodefense and emerging infectious diseases. The Pilot 
Program would encourage innovation by allowing early-stage 
investigators to propose bold new ideas with a minimal requirement for 
supporting data. NIAID released a request for information in 2018 to 
seek input on the Pilot Program from stakeholders throughout the 
scientific research community and the general public. The Institute is 
now reviewing the public input and finalizing the design of the Pilot 
Program. NIAID anticipates that the Pilot Program will help advance 
innovations in NIAID research, including promising approaches for 
emerging and re-emerging infectious diseases. These NIAID activities 
will help ensure support for the scientific workforce necessary to 
address emerging public health threats.
    The FAST Act mandated that HHS issue technical guidelines for the 
adoption of hair testing as a federally-accepted drug testing method 
within 1 year of the bills enactment. Unfortunately, that deadline is 
now more than 2 years overdue. Will you commit HHS and SAMHSA to 
completing the required technical guidelines for hair testing that will 
provide trucking companies with an extremely effective tool in 
protecting highway safety this year?
    Answer. In August of 2015, the Substance Abuse and Mental Health 
Services Administration's (SAMHSA) Drug Testing Advisory Board (DTAB) 
recommended that SAMHSA pursue hair as an alternative testing specimen 
with the caveats that `` . . . performance standards that sufficiently 
address external contamination and hair color impact . . . '' be 
established before using hair as a specimen in Federal drug testing 
programs. In addition, Section 5402(b) of the Fixing America's Surface 
Transportation (FAST) Act, enacted on December 4, 2015, required HHS to 
``issue scientific and technical guidelines for hair testing as a 
method of detecting the use of a controlled substance for purposes of 
section 31306 of title 49, United States Code.''
    SAMHSA has critically examined the current state-of-the-science and 
technology concerning hair drug testing and the utility of hair as a 
specimen for use in Federal programs. During this process, SAMHSA 
consulted with subject matter experts including hair testing 
researchers; laboratory practitioners and laboratory directors; medical 
review officers (MROs); and toxicologists with expertise in workplace 
drug testing regulations, programs, technologies, specimens, policy and 
is currently completing several studies. As a result of this 
evaluation, SAMHSA identified a number of unresolved issues that 
currently may limit the feasibility of hair testing for federally 
regulated programs.
    Due to the complex scientific and legal issues associated with hair 
testing, it has taken longer than anticipated to develop the guidelines 
required by the FAST Act. HHS has developed a draft proposal of the 
Mandatory Guidelines for Federal Workplace Drug Testing using hair, 
which is in its final review stages. Once finalized, HHS plans to 
submit this proposal to the Office of Management and Budget (OMB) in 
the second quarter of 2019 for review.
                                 ______
                                 
          Questions Submitted by Senator Shelley Moore Capito
                                  cms
Non-Opioid Alternatives in Surgery/Post-Surgery Settings
    Question. The ``SUPPORT for Patients and Communities Act,'' 
included Section 6082 to encourage you to review Medicare payment 
systems that may incentivize the use of opioids over proven non- opioid 
alternatives--such as continuous peripheral nerve blocks and other 
treatments. I know HHS took a small step forward last year with limited 
coverage of an injectable alternative, but it seems like a lot more can 
and should be done here.
    Are you considering any further changes to Medicare's payment 
systems in order to incentivize doctors and healthcare providers to use 
alternative methods over opioids?
    Answer. The Administration has made historic investments to address 
opioid misuse, abuse, and overdose, but significant work must still be 
done to fully turn the tide of this public health crisis. The 
President's Fiscal Year 2020 Budget supports HHS's five-part strategy 
to:
  --Improve access to prevention, treatment, and recovery services, 
        including the full range of medication-assisted treatments;
  --Better target the availability of overdose-reversing drugs;
  --Strengthen our understanding of the crisis through better public 
        health data and reporting;
  --Provide support for cutting edge research on pain and addiction; 
        and
  --Improve pain management practices.
    As you noted, based on recommendations from the President's 
Commission on Combatting Drug Addiction and the Opioid Crisis, CMS 
reviewed its payment policies for certain drugs, specifically non-
opioid pain management treatments, which are bundled into larger 
surgical payments in the hospital outpatient setting and ambulatory 
surgical centers. In response to this recommendation as well as 
stakeholder requests and peer-reviewed evidence, for calendar year 
2019, CMS finalized a policy to unbundle and pay separately for non-
opioid pain management drugs that function as a supply when used in a 
covered surgical procedure performed in an ambulatory surgical center.
    In addition, CMS sought feedback in the Calendar Year 2019 Hospital 
Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical 
Center (ASC) proposed rule on whether other non-opioid alternatives for 
acute or chronic pain, such as drugs and devices, have demonstrated 
decreases in opioid prescriptions and whether they warrant separate 
payment under the OPPS and ASC payment systems. CMS is continuing to 
analyze this issue as the agency implements section 6082 of the SUPPORT 
for Patients and Communities Act, which requires review and revisions 
to payments under the OPPS and ASC payments systems to avoid financial 
incentives to use opioids instead of non-opioid alternatives for pain 
management.
42 CFR Part 2
    Question. Leadership at HHS has commented on more than one occasion 
on the need to modernize 42 CFR Part 2 which sets requirements limiting 
the use and disclosure of patients' substance use records from certain 
substance use programs. Is your Department planning to initiate such a 
rulemaking process?
    Answer. The Part 2 regulations were established in order to protect 
Americans with substance use disorders from facing threats to their 
privacy or encountering discrimination in the provision of their 
healthcare, among other negative consequences. But the law underlying 
Part 2 was adopted more than 40 years ago in a less complex healthcare 
environment, and the Department now believes it can be perceived as a 
barrier to patients' receiving high quality, coordinated medical care.
    Part 2 has become a bigger challenge because more medical 
professionals than ever are getting involved in the provision of 
treatment for substance use disorders. That's a great thing, and it's 
not something we want our regulations to stand in the way of. Reforming 
Part 2 and clarifying the many points of confusion around both Part 2 
and HIPAA will be a boon to all providers who want to provide better 
quality, more coordinated care.
Comprehensive Opioid Recovery Centers (CORCs)
    Question. The ``SUPPORT for Patients and Communities Act,'' 
[Section 7121] authorized $10 million per year for the next 5 years to 
establish Comprehensive Opioid Recovery Centers in at least 10 of the 
States that have been most hard hit by the opioid crisis. The 
President's fiscal year 2020 budget includes $786 million for the 
implementation of the SUPPORT Act, but does not provide additional 
information on the specific funding levels of the various programs 
authorized by the SUPPORT Act. Does HHS intend to fund the 
implementation of the Comprehensive Opioid Recovery Centers out of this 
$786 million in funding and at the full $10 million authorized by 
Congress?
    Answer. The Budget sustains $4.8 billion in critical investments to 
combat the opioid crisis using HHS's five-part strategy focused on 
surveillance, addiction prevention, treatment, and recovery services, 
access to overdose reversal drugs, pain management, and research. We 
look forward to working with Congress in our implementation of the 
SUPPORT Act.
SAMSHA Interagency Task Force on Trauma-Informed Care
    Question. Section 7132 of the ``SUPPORT for Patients and 
Communities Act'' created the Interagency Task Force on Trauma-Informed 
Care and established SAMSHA Assistant Secretary McCance-Katz as the 
chairperson. Section 7132 required that the Task Force membership be 
appointed within 60 days of enactment of the law, which occurred on 
December 24, 2018, with the first meeting to occur sixty days later. It 
is my understanding that the Task Force is not yet organized and 
operational, is this correct? If so, why has this delay occurred and 
what is the timeline for this to be rectified?
    Answer. The Interagency Task Force on Trauma-Informed Care held its 
first meeting on March 31 and again on July 12 with strong 
representation from across Federal agencies. SAMHSA has begun 
organizing the Task Force to address the requirements in the law.
                                 ______
                                 
            Questions Submitted by Senator Cindy Hyde-Smith
                                  ahrq
    Question. The current President of the American Osteopathic 
Association Dr. Bill Mayo is from Mississippi, and we also have a 
relatively new osteopathic school of medicine at William Carey 
University. Compared to their MD counterparts, DOs participate less in 
Federal research programs. How can the Department of Health and Human 
Services work with osteopathic medical schools to ensure that DOs are 
included in Federal research projects, particularly as it relates to 
primary care?
    Answer. AHRQ and other HHS OPVIVs are happy to meet with 
organizations new to getting grants and answer any questions. More 
information about AHRQ's Funding opportunities can be found at (https:/
/www.ahrq.gov/funding/policies/foaguidance/index.html) In addition, 
AHRQ has a number of opportunities to engage in collaborations aimed at 
increasing the uptake of evidence in practice and improving quality and 
outcomes of care. Two current opportunities are our Cardiac 
Rehabilitation Initiative which aims to reduce rates of heart attack 
and strokes in people who have had a cardiac event by engaging 
hospitals across the Nation (https://www.ahrq.gov/news/newsroom/press-
releases/cardiac-rehabilitation-project.html) and our AHRQ evidence-
based Care Transformation Support (ACTS) Initiative which is seeking to 
learn how to best use informatics to make it easier to access evidence 
at the point of care (https://healthit.ahrq.gov/acts).
                                  cdc
    Question. Secretary Azar, I am concerned that the special 
conditions around Prescription Drug Monitoring Programs that the 
Centers for Disease Control has included in the recent notice of 
funding opportunity for the Overdose Data to Action funding this 
Committee provided. Those conditions, which require that States connect 
to the Department of Justice's RxCheck system in addition to the 
National Association of Boards of Pharmacies' PMP Interconnect system, 
impose long-term costs on States and appear duplicative. I have a few 
questions about this decision:
  --It is my understanding that States have had the option of using 
        RxCheck for several years now, but most States have chosen not 
        to. Why have States not adopted RxCheck voluntarily? Why does 
        CDC need to force States to adopt RxCheck?
  --What is the need for two separate interstate data sharing hubs that 
        do the same thing?
  --What is the expected timeline for RxCheck to be fully operational 
        as an interstate data sharing hub for all 50 States, DC, Puerto 
        Rico, and the Defense Health Agency?
  --How will HHS help States and their end-users (pharmacy benefit 
        systems, EHRs, HIEs, etc.) rebuild their integration 
        capabilities to accommodate RxCheck and PMP Interconnect?
  --How many States have connected to RxCheck and are live (i.e. using 
        RxCheck to send and receive interstate data queries)?
  --How many interstate data sharing requests are currently being 
        processed monthly through RxCheck?
  --Does the CDC plan to provide funding for the ongoing annual 
        maintenance costs associated with connecting to RxCheck after 
        the 3-year grant period of the Overdose Data to Action funding 
        is over?
    Answer. The Bureau of Justice Assistance (BJA) included grant 
condition language within their Notice of Awards under their Hal Rogers 
PDMP program. In the interest of Federal collaboration and stewardship, 
CDC included similar language within its fiscal year 2019 Overdose Data 
to Action Notice of Funding Opportunity (D2A NOFO). The award 
conditions reflect CDC's commitment to preserving State flexibility in 
selecting technology solutions that best address a State's needs. CDC 
is committed to ensuring that States have access to multiple platforms 
to support interstate and intrastate integration, regardless of vendor 
used. This includes providing options for prescription drug monitoring 
program (PDMP) interstate data sharing as well as supporting PDMP 
integration within electronic health records (EHRs) and health 
information exchanges (HIEs). The aim is to maximize interconnectivity 
of all innovative resources that exist within this space.
    The award conditions require that
  --States maintain ownership of the PDMP data they collect. This will 
        help ensure that the State (or the State entity that operates 
        the PDMP) maintains control over its data, including the 
        ability to promptly access the data from subrecipients or 
        contractors;
  --States must establish and maintain access to the Bureau of Justice 
        Assistance's (BJA's) designated PDMP data sharing system, the 
        RxCheck Hub. The intent is to give states an optional platform, 
        and therefore greater flexibility, when initiating and/or 
        responding to a data-sharing request.
    A State will not be required to switch its data sharing and 
integration work to RxCheck hub. The award conditions allow each State 
to determine its preferred hub for initiating interstate data sharing 
requests with another State or States. The award conditions do require 
a State to receive and respond to requests received using the preferred 
hub of the initiating State. A State that wishes to initiate queries 
using, for example, PMP Interconnect is fully compliant with the award 
conditions if the state initiates queries using PMP InterConnect. 
States remain free to use proprietary solutions such as the PMP 
Interconnect--Gateway connection for interstate data sharing and 
intrastate integration work. CDC will continue to support States in 
maximizing and enhancing the use of PDMPs.
    Question. What is the need for two separate interstate data sharing 
hubs that do the same thing?
    Answer. Currently, there are a limited number of national platforms 
that facilitate bilateral exchange of data across State lines. The 
first is RxCheck Hub from the U.S. Department of Justice's Bureau of 
Justice Assistance and the second is PMP Interconnect from the National 
Association of Boards of Pharmacy (NABP), which was developed and is 
operated by Appriss, Inc. CDC is committed to ensuring that States have 
access to both the RxCheck hub and PMP Interconnect to support 
interstate and intrastate integration, regardless of State vendor used. 
The special conditions are designed to support State flexibility in 
moving toward interstate and intrastate interoperability. This includes 
providing options for PDMP interstate data sharing as well as 
supporting PDMP integration with electronic health records (EHRs) and 
health information exchanges (HIEs). The aim is to maximize 
interconnectivity of all innovative resources that exist within this 
space. CDC wants to ensure that all States have options to advance 
interstate and intrastate data sharing in a manner best suited for the 
State and the health systems within a State.
    The special conditions require recipients to maintain an active 
connection to the RxCheck hub, and States remain free to use 
proprietary solutions such as the PMP Interconnect--Gateway connection 
for interstate data sharing and intrastate integration work. The award 
conditions allow each State to select their preferred solution to 
initiate interstate data sharing queries. A State that wishes to 
initiate queries using PMP Interconnect is fully compliant with the 
grant conditions if they initiate queries using PMP InterConnect. The 
grant condition requires a State to receive and respond to requests 
received using the preferred hub of the initiating State.
    Question. What is the expected timeline for RxCheck to be fully 
operational as an interstate data sharing hub for all 50 States, DC, 
Puerto Rico, and the Defense Health Agency?
    Answer. As outlined above, CDC is requiring its grantees to be able 
to connect to RxCheck. We defer to BJA to address technical questions 
regarding operability of RxCheck.
    Question. How will HHS help States and their end-users (pharmacy 
benefit systems, EHRs, HIEs, etc.) rebuild their integration 
capabilities to accommodate RxCheck and PMP Interconnect?
    Answer. CDC award conditions do not require States to change 
preferred platforms for intrastate integration efforts. Rather, the 
award conditions apply to interstate data sharing and require that a 
State maintain a connection to RxCheck in order to respond to States 
initiating interstate data sharing requests via RxCheck. Having largely 
addressed interstate data sharing, many States are moving towards a 
broader policy goal of integrating their PDMP with EHRs and HIEs. CDC's 
interest is in working alongside Federal partners to support all States 
by creating open-source pathways towards integration that are scalable, 
financially sustainable, and affordable to all users, including under-
resourced communities and health systems.
    CDC is committed to ensuring that States have access to both the 
RxCheck hub and PMP Interconnect to support interstate and intrastate 
integration. These are CDC priorities, in that they advance the 
meaningful use of PDMPs by making them easier to use and more 
accessible, regardless of vendor used. The aim is to maximize 
interconnectivity of all innovative resources that exist within this 
space. These special conditions may expand the interconnectedness of 
States and bring on additional States as information sharing partners.
    In response to fiscal year 2018 omnibus report language, CDC is 
working with the Office of the National Coordinator for Health 
Information Technology to enhance integration of PDMPs and EHRs. For 
example, CDC/ONC are launching demonstrations in six healthcare systems 
to enable effective integration into clinical workflow and will provide 
technical assistance and resources to States to scale integration 
efforts based on the results of the demonstration.
    Question. How many States have connected to RxCheck and are live 
(i.e. using RxCheck to send and receive interstate data queries)?
    Answer. Twenty-six States are either live, undergoing testing, or 
in the process of authorizing their memorandum of understanding (MOU) 
and connecting with RxCheck. An additional seven States have expressed 
interest in using RxCheck. BJA maintains a map that was most recently 
updated in April 2019, which is located here: http://
www.pdmpassist.org/pdf/RxCheck_states_map_20190411.pdf.
    Question. How many interstate data sharing requests are currently 
being processed monthly through RxCheck?
    Answer. CDC defers to BJA, which administers RxCheck, to address 
this technical question.
    Question. Does the CDC plan to provide funding for the ongoing 
annual maintenance costs associated with connecting to RxCheck after 
the 3-year grant period of the Overdose Data to Action funding is over?
    Answer. Connection to the RxCheck hub is free. Although there is no 
direct cost to connect to RxCheck hub, Overdose Data to Action award 
recipients can use the first year of PDMP enhancement funds to assist 
in complying with these special conditions if connection fees are 
instituted by vendors. CDC will include a $215,000 enhancement in the 
award to cover vendor fees associated with connecting to RxCheck. 
Overdose Data to Action is a 3-year funding award. CDC is poised to 
continue to support states with resources for opioid overdose 
prevention, contingent upon Congressional intent and appropriation.
    Question. Last fall, I joined several of my colleagues in a letter 
urging the Department to utilize its existing authority and extend the 
time window needed to fully develop medical residency programs. This 
additional time, commonly referred to as ``cap flexibility'', can 
greatly aid a program in the midst of recruiting residents and faculty 
members needed to keep pace with a community's changing public health 
needs.
    Can you describe in detail how the Department intends to carry out 
this authority as granted back in 1997, under Public Law 105-33?
    Secretary Azar, research indicates that the location of a 
physician's residency and/or fellowship program is predictive of their 
ultimate practice location. This holds true in rural areas whereby 
graduates are three times more likely to stay in the region than urban 
residency program graduates. Knowing of this trend, can we get your 
commitment to cap flexibility as an additional physician retention tool 
tailored for areas facing workforce disparities?
    Answer. We share your goal of improved support for hospitals' 
efforts to train more residents in underserved areas. To this end, the 
President's Fiscal Year 2020 Budget includes a proposal that would 
consolidate Federal GME spending from Medicare, Medicaid, and the 
Children's Hospitals GME program into a single grant program for 
teaching hospitals. Under this proposal, the Secretary would have the 
authority to modify the amounts distributed based on the proportion of 
residents training in priority specialties or programs (e.g., primary 
care, geriatrics) and based on other criteria identified by the 
Secretary, including addressing healthcare professional shortages and 
educational priorities. This program will be more responsive to rural 
health workforce needs. Patients and providers would be well served by 
these commonsense reforms. The new grant program would be operated 
jointly by CMS and the Health Resources and Services Administration 
Administrators.
                                  hrsa
    Question. Secretary Azar, how many hospitals have already been 
helped so far through the HRSA project with the Delta Regional 
Authority? Do you have any success story you can share at this time?
    Answer. There are currently twelve hospitals receiving technical 
assistance through the HRSA project with the Delta Regional authority. 
It is anticipated that ten more hospitals will be selected to receive 
technical assistance in the upcoming year, which will expand the 
program's reach to all eight States in the Delta region.
    Each of the twelve hospitals receiving technical assistance have a 
broad range of challenges to address with some more severe than others. 
While it does take time to see quantitative outcomes through this type 
of project, there are two hospitals in Missouri that were on the brink 
of closure and have remained open after receiving technical assistance. 
The first hospital, the Iron County Medical Center, received a 
Financial Operational assessment and Primary Care Option assessment 
within three weeks of participating in this program. This quick action 
allowed the hospital to avoid closure and instead seek debt relief 
through Chapter 9 Bankruptcy, which will allow the hospital time to 
build financial stability. Additionally, the Primary Care Options 
assessment found consolidation opportunities that will add over 
$500,000 to the hospital's bottom line.
    Another example is the Pemiscot Memorial Hospital. Through the 
technical assistance program, the hospital leadership developed and 
implemented policies and procedures to ensure corporate compliance, 
especially with regard to physician payment, as well as physician 
contracts that now target quality and productivity. The hospital 
leadership now has control of payment to physicians through sound 
contracting and payment processes, which helps to ensure future 
financial success of the organization. The hospital executive team 
cites specific changes in culture and they are now driving performance 
improvements with the Board of Director's support and engagement.
    Question. Secretary Azar, both Mississippi and South Carolina are a 
part of the President's proposed HIV initiative. HRSA's Centers of 
Excellence in Telehealth also located in Mississippi and South 
Carolina. How can telehealth be used to provide linkages to care for 
HIV patients, especially for patients in rural States? How can HRSA use 
its Centers of Excellence, especially those with existing sites in 
FQHCs, to develop a model of using technology to reach those rural HIV 
patients?
    Answer. The HRSA Telehealth Centers of Excellence (COEs) are 
located in academic universities in Mississippi and South Carolina 
(University of Mississippi Medical Center and Medical University of 
South Carolina, respectively) and have implemented a wide range of 
telehealth projects. The programs can focus on the delivery and impact 
of telehealth across a variety of areas, some of which include:
  --Diagnosis based programs--diabetes care, hypertension, chronic 
        obstructive pulmonary disease (COPD), stroke, and HIV
  --Care access--telemergency care; primary care, including federally 
        Qualified Health Centers (FQHCs); school based settings; and 
        correctional facilities
  --Telehealth education--distance education for medical and nursing 
        students and clinicians
    In addition to a varied program focus, the COE's integrate a wide 
range of technology and modalities including direct-to-consumer, remote 
monitoring, mobile carts and video conferencing. Also, as part of their 
program goals, the COEs continue to partner with primary care sites and 
rural community hospitals to incorporate telehealth programs and 
networks to improve access to healthcare services in rural and 
underserved communities, particularly those with high rates of poverty 
and chronic disease. The Centers of Excellence can examine applications 
and approaches to apply telehealth to rural HIV patients. In their role 
as telehealth service testbeds, the Centers are able to test the most 
promising ways to virtually bring the expertise of Ryan White treatment 
centers into FQHCs which are not currently enabled for HIV treatment. 
They can also examine telehealth as a way to incorporate pre-exposure 
prophylaxis management or TelePrEP into FQHCs and will test 
opportunities for compliance assessment and monitoring of patients in a 
non-traditional treatment center, lowering stigma and increasing 
convenience in access, as well as assess how the ECHO model may be used 
for HIV training in FQHCs. These partnerships afford the COEs a unique 
position to support a comprehensive approach to the care of patients 
living with HIV.
    Question. Secretary Azar, physician workforce is so important in my 
State, where we have the worst physician shortage in the country. 
Experts project a national physician shortage ranging between 40,800 to 
104,900 by 2030. These projections are hitting underserved areas 
throughout Mississippi particularly hard, causing an even greater 
impact when one of our local hospitals closes. Separate from 
consolidating graduate medical education programs, as outlined in the 
Fiscal Year 2020 Budget Proposal, please describe the steps that agency 
officials are taking to address this patient care crisis.
    Answer. HRSA works to foster a healthcare workforce that is able to 
address current and future needs. Below are some of the many steps HRSA 
has taken through its programs to address the shortage of physicians in 
rural and underserved communities.
  --National Health Service Corps (NHSC) ($415 million in fiscal year 
        2020): The NHSC provides loan repayment and scholarships to 
        clinicians in exchange for their working in underserved 
        communities in urban, rural, and Tribal areas.
    --Across the Nnation, NHSC clinicians serve patients in Health 
            Professional Shortage Areas (HPSAs)--communities with 
            limited access to healthcare. As of September 30, 2018, 
            there were 10,939 primary care medical, dental, and mental 
            and behavioral health practitioners providing service 
            nationwide via the NHSC.
  --Teaching Health Center Graduate Medical Education (THCGME) program 
        ($126.5 million in fiscal year 2020): Bolsters the primary care 
        workforce through support for new and expanded primary care and 
        dental residency programs. Unlike most residency programs that 
        train in hospitals, the THCGME Program was created to 
        specifically increase physician training in community-based 
        settings such as federally Qualified Health Centers.
  --Since the THCGME program began, 880 new primary care physicians and 
        dentists have graduated and entered the workforce.
  --64 percent of THCGME gradate physicians and dentists are currently 
        practicing in a primary care setting and approximately 58 
        percent are currently practicing in a medically underserved 
        community and/or rural setting. In comparison, the national 
        average of physicians going into primary care is only 
        approximately 33 percent.
  --National Center for Health Workforce Analysis ($4.6 million in 
        fiscal year 2020): Through the National Center for Health 
        Workforce Analysis, HRSA collects and analyzes health workforce 
        data and information to inform targeted workforce investments.
                                 ______
                                 
              Question Submitted by Senator James Lankford
    Question. An Obama administration rule change that took effect on 
January 11, 2017 expanded the non-discrimination clause of Title IV-E 
of the Social Security Act, which has resulted in faith-based Child 
Placing Agencies being faced with the dilemma of no longer considering 
religious beliefs when placing children in homes at the risk of losing 
funding and possibly their CPA license.
    On January 23, the Administration issued an exception to South 
Carolina as it relates to this rule, so that its faith-based child 
welfare organizations can continue to help children and families across 
the State. But as you know, there are many more faith-based adoption 
agencies in the country. What is the plan moving forward in regard to 
this rule or additional waivers?
    Answer. The rule in question has been challenged in litigation and 
it would be inappropriate to comment on it at this time. With respect 
to future RFRA exceptions, the Department will consider requests from 
fund recipients for exceptions from certain Departmental requirements, 
as South Carolina and Miracle Hill so requested from the religious non-
discrimination provision of 45 CFR Sec. 75.300(c), or requirements from 
any other HHS regulation they believe substantially burden their 
religious exercise or reduce the scope of available foster and adoption 
care providers. No case is prejudged and each request is considered on 
its own merits in light of the facts and the law. The Department's 
Office for Civil Rights may also consider complaints under its 
authority that a Departmental requirement violates a person's or 
entities' religious beliefs or moral convictions. Such conscience 
complaints are also independently considered on the basis of their own 
factual and legal circumstances.
                                 ______
                                 
              Questions Submitted by Senator Patty Murray
Child Care
    Question. High-quality, affordable child care is crucial to 
ensuring that parents can go to work, school, or enroll in job training 
to increase their skills. It also helps children start school ready to 
succeed and grows our economy. Yet, analysis from HHS' Office of 
Planning, Research, and Evaluation shows that only 15 percent of 
children eligible for child care assistance under Federal rules 
receives it, whether through CCDBG or a related funding stream like 
TANF or SSBG. If child care is such a priority for you and this 
Administration, why doesn't your budget increase funding for CCDBG so 
that more children and families can get the help they need?
    Other than CCDBG, State expenditures on child care also come from 
TANF and SSBG, whether directly or through transfers. How does your 
Budget support families' child care needs, given that it eliminates 
SSBG and cuts funding for TANF?
    Answer. We agree that quality, affordable child care is important 
for both the health of the economy as well as the well-being of our 
Nation's children. We know that the need for quality child care options 
is greater than the current supply and this budget reflects our 
commitment to working with States to increase the supply of affordable 
child care and ensure that children are cared for in safe settings that 
support their development.
    Some additional context may be useful regarding the HHS Office of 
the Assistant Secretary for Planning and Evaluation's estimate that 15 
percent of eligible children are served. It should be noted that this 
figure:
  --reflects the latest available data and does not take into account 
        potential changes in the number of children served as a result 
        of funding increases in fiscal year 2018 and fiscal year 2019;
  --does not take into account that not all eligible families apply for 
        child care subsidies and may have children enrolled in other 
        programs/services, they may not be aware of the availability of 
        subsidies, or they may have trouble navigating the subsidy 
        system;
  --reflects the percent of eligible children served under Federal 
        eligibility rules, whereas the ASPE analysis also finds that 
        under State eligibility rules (which are narrower than Federal 
        rules), the percentage of eligible children served is 
        approximately 25 percent.
    This budget proposes to maintain the large increases to the Child 
Care and Development Block Grant (CCDBG) discretionary funding that 
were included in the fiscal year 2018 and fiscal year 2019 
appropriations. States are already using these funds to increase 
supply, improve payment rates, and meet other new requirements of the 
Child Care and Development Fund (CCDF) program. Maintaining this 
increase will ensure that States can continue making key changes to 
improve their Child Care and Development Fund (CCDF) programs.
    This budget proposal also includes a significant increase to Child 
Care Entitlement (CCE), which when combined with CCDBG funding, is 
estimated to serve approximately 1.8 million children and continue the 
progress made since reauthorization to improve the supply and quality 
of care and provide transparent information to both providers and 
parents. This CCE increase offsets changes made in other parts of the 
budget, including the Social Services Block Grant funding elimination 
and TANF program changes, to maintain investments in child care.
    There is also a proposed one-time investment of $1 billion in CCE 
funding for a competitive fund aimed at building the supply of care for 
underserved populations and to stimulate employer investment in child 
care. The funding, available for obligation for 5 years, will be 
awarded to States with the goal of building the supply of care by 
helping certain categories/types of providers enter and stay in the 
market. This would include home-based providers, providers serving 
student parents, and providers offering care during non-traditional 
hours.
    HHS is committed to helping low-income working families meet their 
child care needs, and this budget reflects this priority by supporting 
the tremendous work that States are already doing parents and their 
children.
                                  asa
HHS Employees
    Question. Last September, I wrote you a letter asking that HHS 
bargain in good faith with its employees instead of declaring an 
impasse and turning to the Federal Services Impasses Panel (FSIP) to 
impose a contract that the employees had no real say in. Now it appears 
that the FSIP has essentially sided with HHS and rolled back key 
provisions that HHS employees and their union had fought for over 
years--rolling back telework opportunities, shortening employee 
appeals, restricting leave and limiting the amount of official time 
available for use by union leaders.
    Why has the Department proceeded with the anti-worker provisions 
listed above? Why did HHS engage in classic ``surface'' bargaining, as 
outlined in my September 2018 letter? Do you agree that imposing a 
contract without employee input could have a significant impact on 
employee morale?
    Answer. Thank you for your questions concerning the Collective 
Bargaining Agreement (CBA) between the Department of Health and Human 
Services (HHS) and the National Treasury Employees Union (NTEU). The 
collective bargaining mandated by statute for the Federal sector is 
quite complex and very labor intensive. That being said, HHS represents 
the taxpayer and the acts as the fiduciary that is responsible for 
maintaining the efficient and effective government.
    HHS began bargaining with NTEU over the successor agreement in 
2015. Initially, NTEU was not interested in discussing the ``ground 
rules'' for the term agreement. After some time, NTEU negotiated on two 
separate occasions for a total of four (4) hours and then requested 
Federal Mediation Conciliatory Service Assistance. (FMCS) After four 
(4) hours with a mediator, NTEU moved the ``ground rules'' to the 
Federal Services Impasses Panel (FSIP) for final disposition, and FSIP 
issued the ground rules order to the parties in a manner favorable to 
NTEU.
    The measures HHS proceeded with were not anti-worker. Our goal was 
to negotiate an agreement that facilitated an efficient work process. 
HHS was ready, willing and available to ``quid pro quo'' bargain at the 
table, but it was clearly apparent that NTEU was not interested 
innegotiating. In this type of situation, the only available option in 
the Federal labor negotiating process is to seek FMCS assistance and 
finally have FSIP intervene and issue a final order.
    NTEU has filed a national grievance in which it raised four issues 
related to bargaining over the term bargaining agreement. Recently, a 
neutral arbitrator hearing this grievance issued an award in which he 
found that HHS did not bargain in bad faith and did not violate rule, 
law or regulation. The arbitrator also found that the facts did not 
support any of the grievances, and he dismissed the grievance in full.
    HHS is proud of our mission and our employees. As the second (2nd) 
highest ranked large Federal agency, as rated by our employees in the 
2018 Federal Employee Viewpoint Survey, it is quite clear that we are 
employee and efficiency focused.
                                  aspe
Foundations for Evidence-Based Policymaking Act
    Question. Earlier this year, the President signed into law a bill I 
co-wrote with former Speaker Paul Ryan called the ``Foundations for 
Evidence-Based Policymaking Act of 2018'' (Public Law 115-435).
    What steps is the Department of Health and Human Services taking to 
prioritize implementation of the bill's key provisions, including those 
related to developing a multi-year learning agenda, tapping senior 
leaders to fulfill the law's goals (i.e., the Chief Data Officer, 
Evaluation Officer, and Statistical Officer), improving coordination of 
data at the Department, and ultimately improving accessibility of 
health and human services data?
    Answer. The Department is currently evaluating the most appropriate 
approach for implementing the Foundations for Evidence-Based 
Policymaking Act of 2018 (Evidence Act). We are currently in the 
process of implementing a leadership and coordinating structure for 
implementation of all three titles of the Act in accordance with the 
law and per recent guidance from the Office of Management and Budget.
    The HHS Data Council was named as a best practice for coordinating 
data in the Commission on Evidence-Based Policymaking's 
Recommendations, and is actively participating in the Department's 
efforts to appropriately implement the Evidence Act. The HHS Data 
Council has formed three subcommittees to examine the best approaches 
to coordinate and share data for evidence-building purposes: models for 
building and maintaining a data catalogue; data governance models as 
well as issues pertaining to privacy, security, and confidentiality 
across HHS; and the data science workforce needed to ensure a 
coordinated approach to workforce capacity and issues. Additionally, 
HHS will be using the Evidence and Evaluation Council for 
implementation of developing multi-year evidence-building plans, 
evaluation plans, and conducting a capacity assessment.
    Question. The Department did not include a request for additional 
resources to support implementation; how does the Department intend to 
ensure the capacity exists to implement this new law?
    Answer. The date the bill was signed into law did not provide 
sufficient time to assess the impact of implementing the law. We will 
be reviewing fiscal year 2022 HHS budget guidance as part of 
implementation and we will work with the leadership and coordinating 
structure mentioned above.
    Question. What is the Department's timeline for designating the 
senior leaders?
    Answer. The Department anticipates designating the Evaluation, 
Statistical, and Chief Data Officers later this summer.
HIV Initiative
    The budget includes a new initiative aimed at ending our Nation's 
HIV epidemic in the next decade through modest, but focused, increases 
for the Centers for Disease Control and Prevention, the Indian Health 
Service, and the Ryan White HIV/AIDS Program. However, the budget's 
deep cuts to the Medicaid program would gravely compromise efforts to 
eliminate new infections. The President's renewed call for repealing 
the Affordable Care Act and over $2 trillion in cuts to Medicaid and 
Medicare would greatly setback access to healthcare for people living 
with HIV, hobbling efforts to end the epidemic domestically. The bottom 
line is ending the HIV epidemic requires affordable, comprehensive 
health coverage and a robust and sustainable healthcare system, which 
this Administration is working to undermine daily.
  --Has HHS evaluated how many people living with HIV/AIDS will be 
        affected if this Administration is successful at striking down 
        the ACA and Medicaid expansion?
  --How can communities fight the HIV epidemic if you cut billions from 
        Medicaid and large numbers of people living with HIV find 
        themselves unable to pay for care?
    Answer. The Ending HIV Epidemic initiative is funded solely through 
discretionary resources. The resources proposed in the budget will 
cover testing, diagnosis, PrEP, and treatment for individuals who are 
uninsured or under-insured. To the extent that reductions in HIV 
infections and the related cost of the treatment of disease are 
mitigated by these prevention efforts, we expect in actuality the cost 
burdens to programs like Medicaid, which covers a broad range of 
services for individuals living with HIV/AIDS, to be reduced.
Sexually Transmitted Diseases and HIV
    Question. According to the CDC, the rates of sexually transmitted 
diseases are at the highest levels ever recorded, with 2.3 million 
cases of chlamydia, gonorrhea, and syphilis diagnosed in 2017. If left 
untreated, STDs can lead to infertility, newborn death, and an 
increased risk of HIV transmission. I was also particularly alarmed to 
see the rise in congenital syphilis where 40 percent of the cases 
result in infant or newborn death.
  --How does your Department plan to address this growing public health 
        problem, particularly without any request for increased funding 
        to prevent the spread of these diseases?
  --Given that research studies indicate that having an STD makes it 
        easier to transmit HIV, how does your agency plan to address 
        STDs in the proposed initiative to end HIV?
    Answer. As you noted, rates of sexually transmitted diseases (STDs) 
are increasing rapidly in the United States. These increases are 
leading to adverse health effects, including infertility, ectopic 
pregnancy, stillbirth in infants, and increased HIV risk. In response 
to this public health concern, the Department is initiating a process 
to develop the first national action plan to address STDs.
    The Office of HIV/AIDS and Infectious Disease Policy (OHAIDP) has 
begun this process by launching an STD Action Plan Federal Steering 
Committee. The Federal Steering Committee will help oversee the 
development process and ensure that the final action plan will serve as 
a solid foundation to improve national efforts to address the alarming 
rise in STDs.
    The proposed HIV initiative will incorporate prevention strategies 
that build off the information we already know: STDs can increase the 
risk of spreading HIV; some activities can put people at increased risk 
for both STDs and HIV; and people who have STDs are more likely to get 
HIV, when compared to people who do not have STDs.
                            joint ocr/samhsa
HHS Office for Civil Rights (OCR)
    Question. HHS OCR fiscal year 2020 budget request for the Health 
Information Privacy (HIP) Division was $1,562,000, which is $2,525,000 
below the fiscal year 2019 Enacted Level. The budget request indicates 
that OCR plans to fund 20 FTEs for the HIP Division or 2 below the 
fiscal year 2019 level. The HIP Division is considered a high growth 
area for OCR that is actively working to implement provisions of the 
HITECH Act and the 21st Century Cures Act. Given that the rate of 
health information privacy cases increased 12 percent from fiscal year 
2017 and this trend is likely to grow, how will the HIP Division 
continue to investigate and resolve industry compliance with HIPAA 
privacy, security and breach notification regulations with a smaller 
budget and less FTE support?
    Answer. OCR's dedication to vigorous enforcement of health 
information privacy laws remains unwavering. OCR has access to 
carryover from HIPAA settlements that will enable OCR to continue 
accomplishing its vital mission of enforcing our health information 
privacy laws with the funds and authorities Congress has given it, 
while furthering all other aspects of OCR's mission, including vigorous 
civil rights and conscience and religious freedom enforcement.
                                  ocr
    Question. The HHS OCR Conscience and Religious Freedom Division 
(CRFD), established in fiscal year 2018 in response to the President's 
Executive Order to ``vigorously enforce Federal law's robust 
protections for religious freedom'' is the only division in OCR that 
features a substantial increase in the fiscal year 2020 budget request. 
OCR did not meet its target for half of the performance measures listed 
in its fiscal year 2019 overview of outputs and outcomes, including its 
target for investigated complaints resulting in corrective action, the 
number of covered entities making substantive policy changes, and the 
management of civil rights administrative closures. The CRFD 
discretionary budget request of $4,889,000 is $1,071,000 above the 
fiscal year 2019 Enacted Level, and this funding would be used to 
support an additional 6 FTEs as well as overhead costs. CRFD high 
impact cases in fiscal year 2018 only constituted 6 percent of the 
cases retained that year. Overall, OCR did not meet its target for half 
of the performance measures listed in its fiscal year 2019 overview of 
outputs and outcomes, including its target for investigated complaints 
resulting in corrective action, the number of covered entities making 
substantive policy changes, and the management of civil rights 
administrative closures.
    Given that OCR is projected to experience a 17 percent increase in 
complaint receipts from fiscal year 2017 to fiscal year 2018 and half 
of its performance measures were not met in the previous fiscal year, 
how does the Office justify increasing funding for CRFD at the expense 
of funding for other divisions like HIP, which investigates high 
profile cases as a substantial part of its enforcement work?
    Answer. HHS established the CRFD in order to ensure compliance with 
Federal conscience protection laws in HHS health and human services 
programs, including RFRA and the 25 Federal healthcare conscience and 
anti-discrimination laws identified in the proposed rule related to 
conscience protection released on January 26, 2018, as well as the need 
to provide education and guidance on the existence of, requirements 
imposed by, and rights created under, these laws. The need has been 
confirmed by the significant number of complaints received by OCR since 
the beginning of the Administration. The need is additionally sustained 
by and comports with Executive Order 13798, ``Promoting Free Speech and 
Religious Liberty'' (May 4, 2017), 82 FR 21675, which states that the 
Administration will vigorously enforce the Federal law's robust 
protections for religious freedom, as well as the Attorney General's 
Guidance on Federal Law Protections for Religious Liberty (October 6, 
2017), which interprets religious liberty protections in Federal law 
for Federal agencies and provides guidance to Federal agencies in 
conforming their programs to the requirements of such laws. OCR 
established the Conscience and Religious Freedom Division pursuant to 
Secretarial authorization as set forth in 83 FR 2802. This action 
follows previous OCR reorganizations including the establishment of the 
Health Information Privacy and Civil Rights Divisions. See 81 FR 95622 
(2016); 75 FR 60757 (2010); 74 FR 39325 (2009); 69 FR 48243 (2004); 65 
FR 19379 (2000); 57 FR 14723-01 (1992). CRFD carries out its mission 
through case investigation and enforcement, policy development, 
education and outreach, and compliance efforts. CRFD provides the 
organizational structure in OCR to elevate conscience and religious 
freedom to equal footing with OCR's civil rights and health information 
privacy programs. CRFD conducts OCR's nationwide investigation and 
enforcement activities under HHS's conscience and religious freedom 
authorities. The centralization of investigation and enforcement 
activities of conscience and religious freedom issues in Headquarters 
is similar to the model OCR used when it began administering its new 
health information privacy responsibilities in the early 2000s. This 
model maximizes OCR's ability to build expertise and capacity in 
handling complex, sensitive, and novel enforcement and policy questions 
of first impression.
    OCR stood up the division in the second quarter of fiscal year 2018 
and hired its first Deputy Director in the third quarter of fiscal year 
2018. Consequently, fiscal year 2019 is the first year for which OCR 
has set targets for its conscience and religious freedom cases.
    Question. CRFD anticipates that its fiscal year 2018 performance 
may not necessarily be indicative of future fiscal years, CRFD does not 
have historical data on which to base its fiscal year 2019 and fiscal 
year 2020 targets. Unlike CRD and HIP, no other Division in OCR handles 
case outreach, policymaking, processing, and investigation for laws 
assigned to the Division. While OCR's civil rights and health 
information privacy divisions have a many years of institutional 
knowledge to draw from, CRFD must dedicate the resources to build that 
knowledge base through experience and enforcement of conscience and 
religious freedom authorities, often in contested matters of first 
impression.
    According to the its fiscal year 2020 budget request justification, 
in fiscal year 2019 OCR will be on track to make substantial progress 
toward its staffing goals to hire career staff in CRFD equivalent in 
total to four FTEs. If a total of four FTEs are required to support 
CRFD, why does the budget request increase reflect the addition of 6 
FTEs? What associated overhead costs are accounted for in this 
increase?
    Answer. In fiscal year 2019, OCR is staffing CRFD primarily through 
contract support. OCR is working to bring on-board an appropriate 
number of Federal staff. It is important to note that FTE is a measure 
of work-hours, and not a count of employees. Two full-time employees 
brought on board April 1 in fiscal year 2019 would count as only one 
FTE in fiscal year 2019--but as two FTE in fiscal year 2020. Overhead 
costs include benefits such as Social Security contributions, costs of 
phones, computers, and space, and other such costs.
South Carolina Child Welfare Agencies Waiver
    Question. This past January, Secretary Azar granted a waiver from 
non-discrimination requirements to the State of South Carolina (SC), 
with respect to Miracle Hill and any other faith- based subgrantee in 
the SC Foster Care Program. In the March 14th Senate Finance Committee 
hearing, Secretary Azar testified that Miracle Hill is required to 
refer individuals with whom they cannot work to the State placement 
foster care authority or to another foster care provider. However, the 
waiver States that the referral is required ``on the understanding that 
Miracle Hill, and any other subgrantee making use of this exception, 
does not object on religious grounds to making such referrals and, 
therefore, the condition does not implicate additional RFRA concerns.'' 
Under this waiver, will child welfare agencies be required to refer all 
families with whom they are not willing to work?
    Answer. Yes. Under the exception Miracle Hill is permitted to work 
with foster parents who share Miracle Hill's religious beliefs but is 
required to refer potential foster parents with whom they do not 
partner with to other providers.
    Question. How is Secretary Azar's testimony not in conflict with 
the language in the waiver itself?
    Answer. Secretary Azar accurately described the exception during 
his testimony. Specifically, Secretary Azar testified,
    [W]e support as many providers as possible being engaged. And 
        faith-based providers are the bedrock of some of our most 
        difficult placements in terms of disabled, hard-to-place 
        children. They always, historically, have been. And that's why 
        the Roman Catholic Diocese of Charleston as well as the 
        Coalition for Jewish Values supported the accommodation that we 
        provided at the request of the Governor of South Carolina. It 
        was at the Governor's request to provide this exemption, this 
        waiver, to allow them to continue to work with co-religionists. 
        . . . In fact, they are required--if they cannot work with 
        individuals who come forward--this Miracle Hill organization--
        they would be required to refer those individuals to the State 
        foster care authority or to other foster care providers, of 
        which there are many in the State of South Carolina who would 
        be willing to work with them. Our focus is on the kids and 
        child welfare. We need more people as foster parents--not 
        fewer.
    The exception permits Miracle Hill to work with foster parents who 
        share Miracle Hill's religious beliefs and requires Miracle 
        Hill to refer potential foster parents with whom they cannot 
        work to other providers.
    Question. Does the exception to 45 CFR 74.300 [sic] that HHS 
granted to South Carolina apply to all religiously motivated 
exclusions?
    Answer. No. The exception applies only to similarly situated 
religious organizations that are operating under South Carolina's Title 
IV-E Foster Care Program (the ``SC Foster Care Program'') meaning 
entities that use similar religious criteria in selecting among 
prospective foster parents and, consistent with their beliefs, refer 
potential foster parents that do not adhere to the religious 
organization's religious beliefs to other providers. As the letter 
dated January 23, 2019, from Principal Deputy Assistant Secretary 
Steven Wagner to Governor Henry McMaster states,
    The exception applies with respect to Miracle Hill or any other 
        subgrantee in the SC Foster Care Program that uses similar 
        religious criteria in selecting among prospective foster care 
        parents. The exception applies on the condition that Miracle 
        Hill, or any other subgrantee making use of this exception, be 
        required to refer potential foster parents that do not adhere 
        to the subgrantee's religious beliefs to other subgrantees in 
        the SC Foster Care Program, or to refer them to the SC Foster 
        Care Program staff themselves, if the SC Foster Care Program 
        staff is equipped to refer those persons to other willing 
        subgrantees. This condition is added on the understanding that 
        Miracle Hill, and any other subgrantee making use of this 
        exception, does not object on religious grounds to making such 
        referrals and, therefore, the condition does not implicate 
        additional RFRA concerns.
    Question. For example, does it apply to religiously motivated 
exclusions of same-sex couples or does HHS deem Miracle Hill's 
religiously motivated exclusion of same-sex couples impermissible while 
agreeing with their ability to discriminate on the basis of religion? 
How does HHS plan to assure that the needs of LGBTQ-identified youth, 
who represent 4 out of 5 children in in foster care, will be addressed 
and that they are protected from harassment, discrimination and forms 
of conversion practices when being placed by an agency that professes a 
deeply held belief against being LGBTQ?
    Answer. The waiver granted by HHS applies to the religious non-
discrimination provision of 45 CFR Sec. 75.300(c) with respect to 
Miracle Hill's desire to recruit and work with co-religionists as 
potential foster parents. HHS has not granted waivers to other 
provisions of 45 CFR Sec. 75.300 and it would not be appropriate to 
speculate on hypotheticals or prejudge any particular factual and legal 
circumstance that has not been presented to the agency.
    In granting the exception requested by the State of South Carolina, 
HHS acted to preserve the participation of faith-based service 
providers for the State's foster care program. As the letter granting 
the exception itself states, ``this exception does not relieve the SC 
Foster Care Program of its obligation to comply with any other 
requirements of 45 CFR Sec. 75.300(c), of other paragraphs of 45 CFR 
Sec. 75.300, of 42 U.S.C. Sec. 671(a)(18), or of any provisions of 
civil rights statutes, including Title VI of the Civil Rights Act of 
1964, Title IX of the Education Amendments of 1972, the Age 
Discrimination Act of 1975, and section 504 of the Rehabilitation Act 
of 1973 that may apply.'' \2\ HHS will continue to assure that all 
eligible children are served without unlawful discrimination, including 
children who identify as LGBTQ.
---------------------------------------------------------------------------
    \2\ 42 U.S.C. Sec. 2000d et seq., 20 U.S.C. Sec. 1681 et seq., 42 
U.S.C. Sec. 6101 et seq., and 29 U.S.C. Sec. 794, respectively.
---------------------------------------------------------------------------
    The Children's Bureau at the Administration for Children and 
Families, Department of Health and Human Services, funded the National 
Quality Improvement Center (QIC) on Tailored Services, Placement 
Stability and Permanency for Lesbian, Gay, Bisexual, Transgender, 
Questioning, and Two-Spirit (LGBTQ2S) Children and Youth in Foster Care 
in 2016. This 5-year, $10 million grant was developed to improve the 
safety, well-being and permanency of LGBTQ2S children and youth through 
the development and implementation of: safe spaces in child welfare and 
provider facilities; tailored assessments and services in affirming and 
culturally sensitive environments; identification of data collection 
procedures that ensure confidentiality; placement stability supports to 
children, youth, and caregivers, including birth families in 
reunification cases; permanency innovations for those not reunified 
with families of origin; and increased LGBTQ competence and response by 
agency staff, foster and non-foster family caregivers, and service 
providers in congregate care settings.
    Question. In the President's fiscal year 2020 Budget there is a 
line item entitled ``Protect the religious liberty of child welfare 
providers'' (page 124). In February, the Washington Post reported that 
administration officials stated their intention to include this in the 
budget to allow federally funded agencies to ``reject LGBTQ parents, 
non-Christians, and others.'' What are the details of this proposal and 
how does it comply with Federal non-discrimination laws and 
requirements? What will be the impact on the 443,000 children currently 
in foster care?
    Answer. The Department believes faith-based providers are the 
bedrock of some of our most difficult placements in terms of children 
with disabilities and, historically, always have been. In the 
President's Fiscal Year 2020 Budget there is a line item entitled 
``Protect the religious liberty of child welfare providers'' (page 
124). This proposal is consistent with the Secretary's testimony and 
the Department's grant of an exception to the State of South Carolina. 
In light of the foster care crisis resulting from insufficient numbers 
of foster families, and the concurrent moves by some States to close 
foster care providers on the basis of the providers' religious beliefs, 
the Administration believes Congress should protect adoption and foster 
care providers from discrimination or from burdens imposed on their 
exercise of their faith that may eliminate them from contributing to 
the number of foster placements made in a State. Such an action by 
Congress would increase the scope of available foster and adoption care 
providers and help alleviate the present crisis.
                                  uac
ORR--Family Separations
    Question. A report released by HHS's Office of the Inspector 
General in January 2019 found that thousands of children may have been 
separated prior to implementation of zero tolerance, but were not 
tracked because there was no integrated data system between The 
Department of Homeland Security and HHS. While HHS has since updated 
its data system, the Inspector General found that DHS is providing 
``limited information about the reason for these separations'' when the 
child is transferred to HHS's care.
    Secretary Azar testified in the House LHHS Appropriations fiscal 
year 2020 hearing that he has asked for more information from DHS on 
the cause for any family separations. Has the information from DHS 
improved? If not, how are you pushing back on DHS to make sure your 
caseworkers have all the necessary information to make an appropriate 
determination on the child's placement?
    Answer. When U.S. Customs and Border Protection (CBP) determines 
that it is necessary to separate an alien child from his or her parent 
or legal guardian, the child is referred to HHS' Office of Refugee 
Resettlement (ORR). CBP generally provides ORR with the child's I-213, 
as well as general information regarding the reasons for the 
separation. CBP also generally provides ORR with biographical 
information about the separated parent/legal guardian. Additionally, 
CBP may provide additional information in a general ``notes'' section 
of their data push to HHS ORR. When additional information is needed, 
ORR staff can request it through email or phone communication.
    Question. What changes has ORR made in its data system since June 
2018 to better identify and track children that were apprehended with a 
family unit and subsequently referred to the UAC program?
    Answer. In July 2018, ORR added a ``YES/NO'' checkbox to the UAC 
Portal for ORR staff to complete when adding UAC referrals from CBP. 
This checkbox enables ORR to pull and track CBP-reported data on UACs 
who were separated from a parent or legal guardian in the UAC Portal. 
In general, ORR tracks and accounts for all UAC referred to ORR.
    Question. What changes have been made to integrate the DHS and HHS 
data systems?
    Answer. DHS and HHS do not have integrated data systems. HHS (ORR) 
receives referrals from DHS (CBP) through a data ``push'' from CBP's 
electronic systems of records into ORR's Portal, and possibly also 
following a phone call, or through an email. CBP provides information 
on separated UAC in a general ``notes'' section of the CBP data push.
    Question. Is HHS coordinating with DHS to ensure they have the 
identified the same children as ``separated''?
    Answer. Yes. HHS and DHS regularly exchange data regarding 
separated children and adults, and work to determine whether 
reunification may be appropriate in a particular case.
    Question. In addition to sharing general information about 
separations, is DHS sharing with HHS the location and contact 
information for the separated parent/legal guardian so that care 
providers can ensure timely communication, if appropriate?
    Answer. Yes. DHS and HHS regularly share information regarding 
separated children and parents/legal guardians. This information 
includes the location of the parent/legal guardian. If necessary, ORR 
case managers can also locate a detained parent's whereabouts in the 
ICE Detainee Locator (found on the ICE website), contact their local 
ICE Field Office Juvenile Coordinator, or contact the ICE Parental 
Interest Unit to initiate communication between the child and the 
parent (whether detained or not).
    Question. Under what circumstances are family separations happening 
today?
    Answer. DHS is the only agency which can describe the circumstances 
in which alien children are separated from their parents, as well as 
the processes or systems involved in such a decision. HHS does not 
separate children and is not involved in the decision to separate 
children from parents. At the same time, HHS has some information on 
the circumstances that result in family separations, as it is required 
to submit monthly reports to Congress on this matter. Please see May 
2019 Report here: https://www.hhs.gov/programs/social-services/
unaccompanied-alien-children/report-to-congress-on-separated-children/
index.html.
    Question. I understand DHS has written criteria on when a 
separation should occur, including on when it would be in the best 
interest of the child. Did DHS consult HHS in developing these 
criteria? Has HHS seen this document, and could you please share it 
with the Committee?
    Answer. HHS does not develop DHS policy. DHS is the only agency who 
can speak to developed written criteria on when separation should 
occur. HHS defers to DHS to share all DHS policies and procedures.
    Historically, separations of an alien minor from an adult parent or 
legal guardian (or an alien claiming to be the minor's parent or legal 
guardian) occurred in certain circumstances, such as (1) if DHS is 
unable to determine a custodial relationship, (2) when DHS determines 
the minor may be at risk with the adult (including for urgent medical 
issues), or (3) if the parent or legal guardian is transferred to 
criminal detention (as the result of a criminal charge or conviction).
    Current DHS policy regarding family separation is in accordance 
with the preliminary injunction in Ms. L v. ICE and the Trafficking 
Victims Protection Reauthorization Act. , CBP may separate an alien 
child from their parent when they enter the United States if the parent 
or legal guardian:
  --poses a danger to the child,
  --is determined to be unfit,
  --has a criminal history,
  --has a communicable disease,
  --or is transferred to a criminal detention setting (other than for 
        prosecution for
  --improper entry (8 U.S.C. Sec. 1325)).
    Outside of these circumstances, CBP generally keeps family units 
together in its short-term holding facilities.
    Question. What efforts is HHS undertaking or planning to undertake 
to continue facilitating family reunification for the remaining 
separated families, especially for the parents or adults who have 
already been deported back to their countries of origin? Please provide 
a detailed timeline.
    Answer. Of the 2,667 minors identified as potentially separated and 
certified as children of the original Ms. L class, all but one child 
are either reunified with parents and legal guardians, or discharged 
under appropriate standards--most through discharge to family member 
sponsors based on parents' waiving reunification. The one child still 
in ORR care is still waiting for a parent to provide an election to 
reunify or waive reunification.
    Within 24 hours of arriving at a UAC care facility, children and 
youth are given the opportunity to communicate with a verified parent, 
guardian, or relative (when contact information is available), whether 
they reside in the United States or abroad. If a minor's parents are in 
Federal custody, the child's case manager will engage with the parents' 
case managers and Federal law enforcement officials to verify their 
relationship, so that they may communicate with one another.
    UACs are allowed to make a minimum of two telephone calls per week 
(10 minutes each) to family members or sponsors, in a private setting. 
Some care providers facilitate video calls (through Skype, for example) 
between tender age children and their families. UACs are also allowed 
unlimited telephone access to their legal representatives. A minor may 
also speak with her or his consulate official, case coordinator, and 
child advocate. (Child advocates are third parties who make independent 
recommendations regarding the best interests of a vulnerable child.)
    For children with parents who are in ICE custody, ORR programs 
facilitate the twice-weekly calls with parents. For UACs who are tender 
age or otherwise nonverbal, program will utilize Skype and other video 
call technology.
    ORR headquarters staff help locate detained parents in ICE custody 
and pass that information on to the program to ensure the communication 
channels are open.
    ORR's care providers encourage visitation between UACs and family 
members (unless there is a documented safety concern) and have policies 
in place to ensure safety and privacy of children and staff. Care 
providers must have an alternative public place for visits, and visits 
must be supervised by staff in a way that ensures safety but respects 
the UAC's privacy and reasonably prevents the unauthorized absence of 
the child or youth.
    Care providers also ensure that all mail, letters, packages, 
baggage or any other items delivered to the care provider and addressed 
to the minor are promptly delivered and that UACs have access to 
postage, and if possible to email, in order to send letters to family 
members, sponsors, legal representatives, and others.
                    orr--sponsor information sharing
    An April 13, 2018, HHS and DHS agreement ``requires HHS to share 
the immigration status of potential sponsors and other adults in their 
households with ICE to facilitate HHS's background checks.'' As we 
know, initiating these background checks resulted in a deterrent effect 
on sponsors coming forward and children were staying longer on average 
in ORR care. On December 18, 2018, HHS announced that it would stop 
requiring fingerprinting of all household members of the sponsor in 
order to be able to release UAC to sponsors more quickly. The fiscal 
year 2019 DHS spending package prohibits DHS from using fingerprinting 
information shared from ORR about certain UAC sponsors and household 
members for purposes of immigration enforcement or deportation. And, in 
March 2019, ORR further announced that it would temporarily suspend the 
fingerprinting requirements for certain Category 1 sponsors.
    Question. What procedures are in place to comply with the fiscal 
year 2019 DHS prohibition?
    Answer. As of April 18, 2019, ORR has not instituted any new 
policies related to the DHS prohibition contained in the Consolidated 
Appropriations Act of 2019 (PL 116-6), and we defer to DHS for any 
procedures it implemented to comply with this provision. HHS notes that 
the prohibition could affect the UAC program in that some potential 
sponsors may be less apprehensive in coming forward to sponsor a child. 
However, the prohibition does not require a change to current ORR 
release policies.
    Question. What sort of facts must be gathered to verify any 
potential risks to the minor?
    Answer. The process for the safe and timely release of a child from 
ORR custody involves many steps, including: the identification of 
sponsors; the submission by a sponsor of the application for release 
and supporting documentation; the evaluation of the suitability of the 
sponsor, including verification of the sponsor's identity and 
relationship to the child, background checks, and in some cases home 
studies; and, planning for post-release.
    ORR care providers use information collected about and from the 
child in conjunction with the sponsor assessment process to determine 
whether to conduct a home study. Home studies are required under 
certain circumstances by the Trafficking Victims Protection 
Reauthorization Act of 2008 (TVPRA) and ORR policy. In circumstances in 
which a home study is not required by the TVPRA or ORR policy, the Case 
Manager and Case Coordinator may recommend that a home study be 
conducted if they agree that the home study will provide additional 
information required to determine that the sponsor is able to care for 
the health, safety and well-being of the child.
    Question. In a home study, what requirements must be met?
    Answer. A home study assesses the potential sponsor's ability to 
meet the child's needs, educates and prepares the sponsor for the 
child's release, and builds on the sponsor assessment conducted by the 
care provider staff to verify or corroborate information gathered 
during that process. The home study is conducted as a collaborative 
psycho-educational process in which the home study case worker 
identifies areas where additional support, resources, or information 
are needed to ensure a successful sponsorship, and provides 
corresponding psycho-educational assistance. The final recommendation 
must present a comprehensive and detailed assessment of the sponsor's 
ability to care for the needs of the child and address any additional 
information that emerges during the course of the home study regarding 
the sponsor, the sponsor's household or the child.

    Question. Have any released children been returned to ORR care as a 
result of the enforcement actions?
    Answer. Children can be re-referred to ORR custody for a variety of 
reasons, including enforcement actions. ORR's database, the UAC Portal, 
does not have a data point that captures the reason for re-referral and 
ORR would need to conduct a lengthy case-by-case analysis to determine 
the reason behind each re-referral.
    Question. What, if any, guidance has ORR provided to grantees to 
ensure that potential sponsors receive accurate information on how 
their information can and cannot be used?
    Answer. Potential sponsors sign an Authorization for Release of 
Information, which states that their information may be shared with 
Federal, State, or local law enforcement agencies. Potential sponsors 
are also provided with a Privacy Notice that explains to whom and under 
what circumstances their information may be shared with other parties. 
The Authorization for Release of Information that is signed by sponsors 
as part of the application process includes language referencing the 
restrictions on DHS's ability to use a sponsor's information for 
immigration enforcement purposes. ORR grantee case managers explain 
these documents to the potential sponsor in a language they can 
understand and make themselves available to answer any questions the 
potential sponsor may have about these documents and the sponsorship 
process as a whole. These documents are also available in Spanish, the 
language spoken by the vast majority of potential sponsors. ORR is in 
full compliance with section 404 of Public Law 116-26.
    The Authorization for Release of Information and Privacy Notice, 
which are part of the Family Reunification Packet provided to all 
potential sponsors, are available on the ORR website at https://
www.acf.hhs.gov/orr/resource/unaccompanied-childrens-services.
    For more details on the sponsorship process, including how ORR 
assesses potential sponsors, background check requirements, the 
application process, and home studies, please see the ORR Policy Guide, 
Section 2: Safe and Timely Release from ORR Care, which can be found on 
the ORR website at https://www.acf.hhs.gov/orr/resource/children-
entering-the-united-states-unaccompanied.
                              orr--asylees
    On page 38 of fiscal year 2020 Justification for Congress by the 
Administration for Children and Families (ACF), ACF lists the 
precipitous rise of eligible asylee arrivals from 25,149 in fiscal year 
2016 to 30,257 in fiscal year 2017 to 39,988 in fiscal year 2018. The 
increase in asylee arrivals seem likely to continue rising in the 
future with the Administration continuing to report large numbers of 
pending asylum cases (e.g., USCIS reported that as of January 31, 2019, 
they have 325,277 pending affirmative asylum cases).
    Question. How many asylees do you project will become eligible for 
ORR services in fiscal year 2020 and fiscal year 2021? Please explain 
how you arrive at those projections?
    Answer. For fiscal year 2020, ORR is predicting 45,600 aslyees will 
be eligible to access ORR benefits. For fiscal year 2021, ORR is 
predicting 48,000 asylees will be eligible to access ORR benefits. ORR 
arrived at these estimates by analyzing information provided by U.S. 
Citizenship and Immigration Services (USCIS) on the number of pending 
asylum claims and information provided by ORR grantees on the number of 
asylees served.
    Question. How will ORR change and expand its outreach and services 
to successfully engage with this growing asylee population?
    Answer. ORR recently updated the ORR website with a new factsheet 
specifically for asylees. There is a section of the ORR website that is 
devoted to asylees and helping eligible people access benefits. The 
fact sheet and additional information specific to asylees is available 
here: https://www.acf.hhs.gov/orr/resource/asylee-eligibility-for-
assistance-and-services-0.
    In addition, ORR has provided annual asylee zip code distribution 
to State Refugee Coordinators (SRC) to facilitate more targeted 
outreach in support of services. SRCs have indicated this outreach has 
proved very effective in making the connection to asylees in need of 
services.
    ORR is also working closely with USCIS to improve outreach and 
service coordination. ORR Regional Representatives are engaging 
regularly with USCIS Community Liaisons to facilitate orientations at 
local asylum offices on services available and improve connections to 
refugee resettlement service providers.
                                 ______
                                 
            Questions Submitted by Senator Richard J. Durbin
    Question. HHS has been in discussions with the National Treasury 
Employees Union (NTEU) to reach a new collective bargaining agreement 
for HHS employees. What steps has HHS taken to address concerns raised 
by NTEU in the negotiation process? How many times did the agency meet 
with NTEU for bargaining and why did HHS refuse NTEU's requests for 
additional meetings?
    In developing proposals and contract language for bargaining, did 
HHS consider the impact of proposals on employee retention and 
recruitment? What evidence does HHS have that proposed contract changes 
will accomplish the goal of reducing agency costs and administrative 
burden? Did the HHS bargaining team consult with HHS management and 
executive personnel in developing the proposals? Please cite any 
studies or data supporting HHS' rationale for developing new proposals 
and contract language to include in negotiations.
    Answer. Thank you for your questions concerning the Collective 
Bargaining Agreement (CBA) between the Department of Health and Human 
Services (HHS) and the National Treasury Employees Union (NTEU). The 
collective bargaining mandated by statute for the Federal sector is 
quite complex and very labor intensive. That being said, HHS represents 
the taxpayer and the acts as the fiduciary that is responsible for 
maintaining the efficient and effective government.
    HHS began bargaining with NTEU over the successor agreement in 
2015. Initially, NTEU was not interested in discussing the ``ground 
rules'' for the term agreement. After some time, NTEU negotiated on two 
separate occasions for a total of four (4) hours and then requested 
Federal Mediation Conciliatory Service Assistance. (FMCS) After four 
(4) hours with a mediator, NTEU moved the ``ground rules'' to the 
Federal Services Impasses Panel for final disposition, and FSIP issued 
the ground rules order to the parties in a manner favorable to NTEU.
    HHS acted as a fiduciary that strives to maintain the efficiency 
and effectiveness of the Federal Government and the taxpayers that 
entrust us with their tax dollars. HHS was ready, willing and available 
to `quid pro quo'' bargain at the table, but the NTEU was not 
interested. After two eight hour sessions, the FMCS determined that the 
parties were at Impasse and released them, both were then free to seek 
the assistance of the FSIP. The only available option in the Federal 
negotiating process is to seek FMCS assistance and finally have FSIP 
intervene if the parties cannot reach agreement. The FSIP in this case 
then ordered the parties to these negotiations to the table for 30 days 
with the assistance of the FMCS regional director. HHS and NTEU reached 
agreement on resolving five additional articles but could not reach 
agreement on any of the others. During that 30-day period, HHS even 
offered to discuss the six (6) additional articles that the FSIP 
eventually remanded for further negotiation between the parties, but 
NTEU refused.
    NTEU has filed a national grievance in which it raised four issues 
related to bargaining over the term bargaining agreement that they 
believed were violations. Recently, a neutral arbitrator hearing this 
grievance issued an award in which he found that HHS did not bargain in 
bad faith and did not violate rule, law or regulation. The arbitrator 
also found that the facts did not support any of the grievance and he 
dismissed the grievances in full.
    HHS is proud of our mission and our employees. As the second (2nd) 
highest ranking large Federal agency, as rated by our employees in 2018 
Federal Employee Viewpoint Survey, it is quite clear that we are 
employee and efficiency focused.
    Question. In 2016, a report came out that Medicare, Medicaid, and 
private insurers wasted $3 billion each year on cancer drugs are 
literally thrown in the trash. This is because many expensive drugs are 
produced in single-use vials, with the dosage based off a patient's 
size and weight. The problem is that PhRMA companies produce them in 
excessively large vials with more medication than needed, and the 
doctor discards the rest. In 2016, I included report language directing 
CMS to study this drug vial waste and provide recommendations--despite 
including language each year since, your agency has refused to begin 
the study. Despite refusing to do the study, your fiscal year 2020 
budget request identifies this very problem, and proposes to shame drug 
wasters with public reports.
    Secretary Azar, why has CMS refused to conduct this study? Will you 
commit to ensuring this study gets done this year?
    Answer. CMS agrees drug vial size and wasted medication is a 
serious issue, and CMS is currently working on a study that will 
examine this important issue. Since January 1, 2017, providers and 
suppliers have been required to flag discarded drugs and biologicals 
for CMS on their Part B claims. Collecting data was the first, vital 
step CMS needed to take to be able to understand and provide evidence-
based analysis on this issue. As noted, the President's Fiscal Year 
2020 Budget also includes a proposal that would require CMS to make 
public which Part B drugs have the highest reported drug wastage using 
data gathered from these claims. Publicly reporting this information 
will allow for a better understanding of which drugs would benefit from 
different packaging to reduce wastage.
    Question. Too often in our country, new moms and infants--
especially women and babies of color--are dying from preventable health 
problems. Nationwide, more than 700 women die every year as a result of 
pregnancy--more than 70,000 others experience severe, near-fatal 
complications. In Illinois, 73 women die every year due to pregnancy-
related complications--70 percent of these deaths are deemed 
preventable. Not only are we losing new moms, we are also losing their 
babies. Annually, more than 23,000 babies die in the U.S., many due to 
preventable factors, such as pre-term birth and low birth weight. 
Secretary Azar, I have introduced a bill--the MOMMA's Act--to expand 
Medicaid coverage to new moms for a full year post-partum, versus 
current law of 60 days. I pay for this expansion by increasing the 
Federal tobacco tax and levying new taxes on e-cigarettes.
    Do you support this? What else can and should HHS be doing to 
address this public health crisis largely affecting women and babies of 
color?
    Answer. HHS is home to a range of agencies whose work touches the 
healthcare of pregnant women, mothers, and infants, as protecting 
maternal and infant health is one of our healthcare system's most 
important responsibilities.
    As the single largest payer for maternity care, Medicaid plays an 
important role in perinatal and maternal health and has a significant 
opportunity to improve maternal and infant health outcomes. The 
President's Fiscal Year 2020 Budget includes a number of proposals 
aimed at improving maternal mortality and morbidity rates in the U.S., 
including allowing States to extend Medicaid coverage to pregnant women 
with substance use disorders for a full year postpartum.
    Access to high quality prenatal care, reducing preterm births, and 
delivering high quality postpartum care lead to improved birth outcomes 
and decreases in maternal mortality. CMS measures the key drivers of 
maternal morbidity and mortality. For example, the measures in the 
Medicaid and CHIP Child and Adult Core Sets assess the quality of care 
women receive at each step in their lifecycle and include quality 
measures associated with major drivers of pregnancy- related mortality 
and severe maternal morbidity. In particular, CMS identified a 
Maternity Core Set of 12 measures for voluntary reporting by State 
Medicaid and CHIP agencies. This Core Set, which consists of eight 
measures from CMS's Child Core Set and four measures from the Adult 
Core Set, is used by CMS to measure and evaluate progress toward 
improvement of maternal and perinatal health in Medicaid and CHIP. 
Reporting of the Core Sets is currently voluntary for States. With the 
passing of the Bipartisan Budget Act of 2018 (Public Law 115-123), 
reporting of the Child Core Set, including maternal and infant health 
measures, will become mandatory beginning in 2024. Additionally, CMS 
has emphasized the importance of maternal infant health by including 
postpartum care and first 15 month well-child visit quality measures in 
the Medicaid and CHIP Scorecard.
    The President's Fiscal Year 2020 Budget also proposes to use CMS's 
Center for Medicare and Medicaid Innovation (Innovation Center) to test 
interventions to improve maternal mortality and morbidity. The 
Innovation Center is currently working on the recently released 
Integrated Care for Kids (InCK) and Maternal Opioid Misuse (MOM) 
payment and service delivery models. These models were designed to 
expand access to healthcare services for vulnerable Medicaid and CHIP 
beneficiaries, in particular those affected by the Nation's opioid 
crisis, and to improve quality of care and reduce expenditures for 
beneficiaries.
    CMS has launched several initiatives and pilot programs to improve 
the well-being of women and children. In 2012, CMS, the Health 
Resources and Services Administration, and the Administration for 
Children and Families launched the Strong Start for Mothers and 
Newborns (Strong Start) initiative to reduce preterm births and improve 
outcomes for pregnant women and newborns. The Strong Start initiative 
was comprised of two strategies. The first was a public- private 
partnership and awareness campaign to reduce the rate of early elective 
deliveries. The second was a 4 year initiative testing the 
effectiveness of three enhanced prenatal care models--Birth Centers, 
Group Prenatal Care, and Maternity Care Homes--among pregnant Medicaid 
and CHIP beneficiaries at high risk for preterm births. Strong Start 
funded 27 awardees and 211 provider sites across 32 States, the 
District of Columbia, and Puerto Rico. Birth Centers were the most 
successful of the models, and CMS determined that women who received 
prenatal care in Strong Start Birth Centers had better outcomes and 
lower costs compared to similar Medicaid beneficiaries not enrolled in 
the initiative.
    In 2014, CMS launched a 3-year Pilot Mobile Health Program to 
engage pregnant and postpartum women enrolled in Medicaid. The program 
delivers evidence-based health education messages and links these women 
to needed community-based resources, using a free text messaging 
service, Text4baby, as the core intervention. The pilot was implemented 
with Medicaid agencies in California, Louisiana, Ohio, and Oklahoma. 
These Medicaid agencies work to integrate Text4baby into their 
processes to complement their States' current maternal and infant 
health activities. In the first year, progress included a substantial 
growth in partnerships to support outreach. Additional information 
about the program and early results can be accessed at the following 
link: https://www.medicaid.gov/medicaid/quality-of-care/downloads/
pilot-mobile-health-program.pdf.
    Additionally, Section 1115 demonstration projects offer States 
additional freedom to test and evaluate innovative solutions to improve 
the quality, accessibility, and health outcomes of pregnant and 
postpartum women and infants in the Medicaid program.
    Several States have used section 1115 demonstration authority to 
implement other types of initiatives aimed at improving maternal health 
outcomes. A summary of those demonstration program initiatives are 
highlighted below.
  --California's Medi-Cal 2020 demonstration includes an initiative 
        called the ``Improved Perinatal Care Project'' that consists of 
        several multi-disciplinary and multi-stakeholder statewide 
        initiatives aimed at improving the health of women and 
        children, and to ensure these health services are delivered 
        safely, efficiently, and equitably. Through the Delivery System 
        Reform Incentive Payment (DSRIP) component of the 
        demonstration, financial incentives are authorized for quality 
        improvement outcomes.
  --New York Medicaid Redesign Team (MRT) demonstration includes 
        several optional projects focused on maternal care under: (1) 
        Domain 3 (Clinical Improvement) focused on increasing support 
        programs for maternal & child health; and, (2) Domain 4 (sub- 
        domain Healthy Women, Infants, and Children) related to the 
        State's Prevention Agenda, which aims to reduce maternal 
        morbidity and mortality. Through the Delivery System Reform 
        Incentive Payment (DSRIP) component of the demonstration, 
        financial incentives are authorized for quality improvement 
        outcomes.
  --Rhode Island's Comprehensive Demonstration includes a ``Family Home 
        Visiting Services Program'' that provides evidence-based 
        prenatal home visiting services through two partnerships. The 
        first is with the Nurse-Family Partnership (NFP) who serves 
        Medicaid beneficiaries who are first time, pregnant women who 
        enroll before 28-weeks gestation; and once enrolled can remain 
        eligible for the program until their child is 2 years of age. 
        The second is with Healthy Families America (HFA) who serves 
        Medicaid beneficiaries that are pregnant (does not have to be a 
        first time pregnancy) or are parents of children under 3 months 
        of age; and once enrolled can remain eligible until their child 
        is 4 years old and the parent remains a Medicaid beneficiary.
  --New Mexico's Centennial Care 2.0 demonstration includes a home 
        visiting pilot program that is operated in collaboration with 
        New Mexico Children, Youth and Families Department (CYFD) and 
        New Mexico Department of Health (DOH). This pilot provides 
        evidence-based, early childhood home visiting services focused 
        on pre-natal care, post- partum care and early childhood 
        development.
  --Maryland's Healthchoice demonstration includes an Evidence-Based 
        Home Visiting Services Pilot that provides visiting services by 
        licensed practitioners or certified home visitors to promote 
        health outcomes, whole person care, and community integration 
        for high-risk pregnant women and children up to 2 years old. 
        Services are provided through two partnerships:
    --Nurse Family Partnership (NFP) reinforces maternal behaviors that 
            encourage positive parent child relationship and maternal, 
            child, and family accomplishments and services are provided 
            until the child reaches 2 years old.
    --The Healthy Families America (HFA) HFA model targets parents 
            facing issues such as single parenthood, low income, 
            childhood history of abuse, SUD, mental health issues, and 
            domestic violence.
  --Illinois Behavioral Health Transformation demonstration includes an 
        evidence-based home visiting services pilot program that 
        provides postpartum home visiting services and child home 
        visits to postpartum mothers who gave birth to a baby born with 
        withdrawal symptoms and Medicaid eligible children up to 5 
        years old who were born with withdrawal symptoms.
    Question. In 2018, youth use of e-cigarettes increased by 78 
percent among high school students and 48 percent among middle-school 
students--today, nearly 4 million children are using e-cigarettes. This 
dramatic uptick is due to products like JUUL and kid-friendly flavors--
fruit medley, fruity pebbles, choco milkshake, smurf, gummy bear . . . 
81 percent of kids vaping started with a flavored product. After a 
rocky start, outgoing FDA Commissioner Gottlieb proposed a number of 
important steps to address youth vaping. Importantly, he wants gas 
stations and convenience stores selling e-cigarette flavors to check 
IDs before customers enter the stores. Secretary Azar, will this ID 
check requirement be effectuated under the next FDA Commissioner in a 
timely manner?
    Answer. HHS is very concerned about the use of e-cigarettes among 
children, which is one of our biggest public health challenges. This 
disturbing and accelerating trajectory of use in youth, and the 
resulting path to addiction, must end. We cannot allow the next 
generation of young people to become addicted to nicotine because of e-
cigarettes.
    The dramatic rise in youth e-cigarette use has prompted a series of 
escalating actions in both enforcement and public education. In March 
2019, FDA issued a draft guidance entitled ``Modifications to 
Compliance Policy for Certain Deemed Tobacco Products.'' Finalizing the 
compliance policy is one of the most critical public health steps that 
we can take to curb youth vaping and address youth use of flavored 
cigars, and the Department and FDA are committed to finalizing the 
draft guidance in a timely manner.
    Evidence shows that youth are especially attracted to flavored e-
cigarette products, and that minors are able to access these products 
from both brick-and-mortar retailers, as well as online, despite 
Federal restrictions on sales to anyone under 18. We also continue to 
be concerned about cigar use among youth--flavored cigars in 
particular--which our enforcement work shows are also being illegally 
sold to minors. We're proposing to prioritize enforcement of flavored 
ENDS products (other than tobacco-, mint-, and menthol-flavored) that 
are offered for sale in ways that pose a greater risk for minors to 
access the products. For instance, we'll consider whether the products 
are sold under circumstances, whether at retail or online, without 
heightened age verification.
    Our proposed policy provides examples of circumstances that we'll 
consider--for example, if flavored ENDS products are sold in locations 
where minors can enter at any time (e.g., the entire establishment or 
an area within the establishment); or, for online sales, if the 
products are sold without an appropriate limit on the quantity that a 
customer may purchase within a given period of time, and without 
independent, third-party, age- and identity-verification services that 
compare customer information against third-party data sources, such as 
public records. We're also considering, among other things, whether 
there are new technologies that can help prevent youth access at retail 
locations and intend to consider the use of those tools when we 
finalize the guidance.
    Our pledge to reduce youth use of e-cigarettes is deeply rooted and 
has broad support within the Trump Administration. Nobody wants to see 
children becoming addicted to nicotine. Our dedication to this effort 
will endure and our commitment to advancing our comprehensive framework 
will continue. Our policies have been announced and advanced through a 
careful and deliberate process that involved the formulation of a broad 
consensus among those whose efforts are needed in making sure that 
these rules and guidance come to fruition. We won't tolerate a whole 
generation of kids becoming addicted to nicotine as a tradeoff for 
enabling adults to have unfettered access to these same unreviewed 
products, and we'll continue to put the full scope of our regulatory 
tools against this mounting public health crisis.
                                 ______
                                 
                Questions Submitted by Senator Jack Reed
    Question. Increasing funding for the Low Income Home Energy 
Assistance Program (LIHEAP) has been a bipartisan priority in the 
Senate. As such, I have been disappointed that this Administration has 
continued to propose eliminating this vital program, which helps low- 
income households and seniors with their energy bills. The number of 
households eligible for LIHEAP already exceeds the program's capacity, 
and for many who do receive energy assistance, the purchasing power of 
the grant has decreased over the past several years. As such, I was 
deeply concerned to learn that although we increased LIHEAP funding by 
$50 million in fiscal year 2019 to help meet the needs of more 
Americans, HHS made the decision to transfer $37 million of LIHEAP 
funds to cover funding shortfalls in another program. Diverting 
critical LIHEAP funds to another program will only further strain these 
limited resources. Secretary Azar, the decision to reprogram LIHEAP 
funds was made in the midst of the winter heating season. Please 
explain the rationale behind your decision to reprogram these funds. Do 
I have your commitment that you will not reprogram any LIHEAP funds in 
fiscal year 2020 and will instead distribute them immediately to States 
so that they can be used for their intended purpose?
    Answer. HHS weighs heavily the factors in whether to transfer any 
program's funding to meet other exigent HHS needs. There have been 
years, such as fiscal year 2018, where HHS had been able to avoid 
transferring funding from LIHEAP to other HHS needs. In fiscal year 
2019, HHS determined that the 1 percent of LIHEAP funding served a 
critical gap in funding needed by our Office of Refugee Resettlement. 
HHS will continue to use cautious and prudent judgment in weighing any 
potential transfer of LIHEAP funding in future years.
    Question. CDC reported in June 2018 that the suicide rate has risen 
30 percent since 1999, but that data is still over 2 years old. What 
programs at CDC are helping to alleviate the suicide crisis and what 
could be done to improve data collection regarding suicide?
    Answer. Suicide is a serious public health problem. Many States and 
communities want to do more to prevent suicide and look to CDC 
expertise and leadership for assistance. For example, in the last year, 
CDC has been asked by multiple States to provide epidemiologic 
assistance or Epi-Aids to respond to suicide clusters. CDC works to 
collect and disseminate data about suicide, provide leadership and 
technical assistance to states to prevent suicide, including a resource 
document--Preventing Suicide: A Technical Package of Policies, 
Programs, and Practices--which outlines 7 key strategies for suicide 
prevention.
    CDC assists States and communities in tracking and monitoring 
suicide injuries and deaths and identifying factors that may have 
contributed to suicides through the National Violent Death Reporting 
System (NVDRS). The NVDRS is CDC's key source of data on suicide and is 
critical to the Nation's efforts to prevent violence. NVDRS is the only 
State-based surveillance system that pools information from multiple 
data sources into a usable, anonymous database in order to provide a 
complete picture on the circumstances of all types of violent 
deaths?including homicide and suicide (as well as opioid-related 
suicides). In 2018, CDC supported NVDRS programs in all 50 States, 
Puerto Rico, and the District of Columbia for a national level 
surveillance system; CDC will provide this same support in 2019 and the 
President's Fiscal Year 2020 Budget proposed to continue that level of 
support.
    NVDRS informs prevention efforts in States and communities to guide 
decisions about preventing violence and monitor progress over time. For 
example, Colorado conducted an analysis of State data to better 
understand suicide deaths among first responders. Colorado's data 
showed that suicide victims who were first responders were more likely 
to have been veterans, compared to the general population of suicide 
victims in their State. These findings helped Colorado direct their 
outreach services, and led them to promote resources focused on 
positive mental and physical health for first responders, active 
military personnel, veterans, and their families.
    In fiscal year 2020, CDC proposes to:
  --Support 52 recipients to collect data as part of the NVDRS system 
        and provide technical assistance to help recipients implement 
        the system, monitor and report data, and use these data to 
        inform prevention efforts.
  --Increase the use of NVDRS data for characterizing suicide at 
        different levels (national, State, and local) and in various 
        populations (ethnic, racial, rural, sexual minorities, etc.).
  --Work with data providers to identify ways to improve data 
        collection and timeliness.
    Question. The National Suicide Prevention Lifeline answered over 
2.2 million calls in 2018. By comparison, the Veterans Crisis Line is 
currently funded at $90 million and answers approximately 2.2 million 
calls per year. Why has the Administration neglected to ask for 
increased funding for the National Suicide Prevention Hotline from the 
current $12 million funding level, when SAMHSA has said that it would 
need approximately $50 million per year in order to simply keep up with 
the current level of calls? Advocates argue that the funding need is 
closer to $80 million to account for implementation of text chat, as 
well as the possibility of increasing calls due to greater public 
education around the hotline.
    Answer. HHS has worked diligently to implement the Garrett Lee 
Smith Youth Suicide Prevention program. The Department has also made 
efforts to implement the Zero Suicide program which focuses on adult 
suicide prevention. In a time of tight budget constraints, SAMHSA's 
suicide prevention efforts are fully funded in the Fiscal Year 2020 
Budget at the same total amount of funding as in fiscal year 2019. The 
SAMHSA programs that received increased funding in the fiscal year 2020 
Budget above the fiscal year 2019 enacted level were related to opioid 
funding, school safety, and funding for individuals with serious mental 
illness.
    HHS fully agrees with the need to adequately resource the National 
Suicide Prevention Lifeline and the fiscal year 2020 budget contains 
the increase in appropriations for the Lifeline that was enacted in 
fiscal year 2019. The $50 million per year figure that is referenced in 
the question is an estimate that SAMHSA included in its report to the 
Federal Communications Commission as part of our responsibilities under 
the National Suicide Hotline Improvement Act. That figure estimates the 
costs to accommodate a 100 percent increase in total Lifeline call 
volume, assuming that the rate of growth of calls to the Lifeline since 
2010 continues at approximately 15 percent. The chart below from the 
administrators of the Lifeline was also provided to the FCC.




                                 ______
                                 
             Questions Submitted by Senator Jeanne Shaheen
              advertising cuts for the affordable care act
    Question. The President's 2020 budget request for the Department of 
Health and Human Services (HHS) references a ``commitment to making the 
Federal Government more efficient and effective.'' I have trouble 
reconciling that objective with the Department's actions to make a 90 
percent cut to the advertising and outreach budget for the Affordable 
Care Act's (ACA's) Health Insurance Marketplaces. Advertising and 
outreach is an important component for increasing enrollment in the 
Marketplaces, particularly for younger and healthier people.
    Recent reporting from the Huffington Post \3\ indicates that prior 
to cutting the funding, senior staff for Centers for Medicare and 
Medicaid Services (CMS) Administrator Verma were presented with 
information suggesting that the advertising and outreach investments 
had been effective in increasing enrollment in prior years--and that 
the cut to the marketing funding would likely result in at least 
100,000 fewer people obtaining coverage on the ACA's Marketplaces.
---------------------------------------------------------------------------
    \3\ Cohn, Jonathan and Young, Jeffrey, ``Emails Show Trump 
Administration Was Told Obamacare Ad Cuts Could Hurt Enrollment,'' 
Huffington Post, December 14, 2018. 
Available online at: https://www.huffpost.com/entry/trump-verma-
obamacare-advertising-cut_
n_5c115061e4b084b082ff8dba.
---------------------------------------------------------------------------
    Do you stand by earlier assertions \4\ from HHS that ``no 
correlation has been seen between Obamacare advertising and either new 
or effectuated enrollment''?
---------------------------------------------------------------------------
    \4\ Id.
    \5\ Pradhan, Rachana and Diamond, Dan, ``Trump wants to bypass 
Congress on Medicaid plan,'' Politico, January 11, 2019. Available 
online at: https://www.politico.com/story/2019/01/11/trump-bypass-
congress-medicaid-plan-1078885
---------------------------------------------------------------------------
    Answer. The Administration remains committed to providing a 
seamless enrollment experience for HealthCare.gov consumers while 
focusing resources on cost-effective, high-impact outreach efforts. 
Data from the Health Insurance Exchanges 2019 Open Enrollment Report 
shows that plan selections for Exchange plans in the 50 States and D.C. 
remained steady at 11.4 million, a small decrease from the same time 
last year. Additionally, demographic data provided in the report also 
demonstrate stability on the Exchanges. The percentage of young adults 
between the ages of 18 and 34 who selected a plan through 
HealthCare.gov remained unchanged from the prior year, at 26 percent. 
Consistent with the 2018 Open Enrollment Period, the consumer 
satisfaction rate at the call center during the 2019 Open Enrollment 
Period remained at an all-time high--averaging 90 percent--throughout 
the entire Open Enrollment Period and, for the second year in a row, 
CMS did not need to deploy an online waiting room during the final days 
of Open Enrollment. As a result, HealthCare.gov consumers were able to 
shop and pick a plan with minimal interruption throughout the entire 
enrollment period.
    Similar to the 2018 Open Enrollment Period, the Administration 
committed resources to this year's Open Enrollment Period and increased 
outreach efforts as the plan selection deadline approached. For 
instance, CMS sent over 700 million reminder emails and text messages 
to consumers, as well as 3.2 million outreach emails to help 
Navigators, agents and brokers assist consumers. In addition, I, along 
with other senior Administration officials, including the CMS 
Administrator, encouraged people to enroll through television and radio 
interviews broadcast to more than 195 stations across the country.
    The Department of Health and Human Services has found efficiencies 
within the operating budget of the Exchanges and reduced the amount 
spent on consumer information and outreach with no harm to consumers 
and no reduction in customer service. To save Federal dollars and 
provide more tailored opportunities for consumers to shop for coverage, 
CMS continues to expand enrollment options for individuals through the 
private sector, including online and in- person agents and brokers as 
well as enrolling directly with health insurers.
    One of this Administration's priorities is to deliver affordable 
coverage options to the men and women left behind by the Patient 
Protection and Affordable Care Act (PPACA). We believe it is important 
that all Americans have access to high quality, affordable health 
coverage that meets their needs and the needs of their families. 
Unfortunately, the PPACA is not working for far too many Americans, 
particularly those middle-class Americans who cannot receive subsidies 
and are shut out from access to affordable coverage options. That's why 
under this Budget, we propose ways that will empower States while 
giving choice and control back to consumers.
     nerve block and non-opioid alternatives to post-surgical pain
    Question. As part of the ``SUPPORT for Patients and Communities 
Act,'' Congress included Section 6082 to encourage you to review 
Medicare payment systems that may incentivize the use of opioids over 
proven non-opioid alternatives--such as continuous peripheral nerve 
blocks and other treatments. I know HHS took a small step forward last 
year with limited coverage of an injectable alternative, but it seems 
like a lot more can and should be done here.
    Are you considering any further changes to Medicare's payment 
systems in order to incentivize doctors and healthcare providers to use 
alternative methods over opioids?
    Answer. The Administration has made historic investments to address 
opioid misuse, abuse, and overdose, but significant work must still be 
done to fully turn the tide of this public health crisis. The 
President's Fiscal Year 2020 Budget supports HHS's five-part strategy 
to:
  --Improve access to prevention, treatment, and recovery services, 
        including the full range of medication-assisted treatments;
  --Better target the availability of overdose-reversing drugs;
  --Strengthen our understanding of the crisis through better public 
        health data and reporting;
  --Provide support for cutting edge research on pain and addiction; 
        and
  --Improve pain management practices.
    As you noted, based on recommendations from the President's 
Commission on Combatting Drug Addiction and the Opioid Crisis, CMS 
reviewed its payment policies for certain drugs, specifically non-
opioid pain management treatments, which are bundled into larger 
surgical payments in the hospital outpatient setting and ambulatory 
surgical centers. In response to this recommendation as well as 
stakeholder requests and peer-reviewed evidence, for calendar year 
2019, CMS finalized a policy to unbundle and pay separately for non-
opioid pain management drugs that function as a supply when used in a 
covered surgical procedure performed in an ambulatory surgical center.
    In addition, CMS sought feedback in the Calendar Year 2019 Hospital 
Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical 
Center (ASC) proposed rule on whether other non-opioid alternatives for 
acute or chronic pain, such as drugs and devices, have demonstrated 
decreases in opioid prescriptions and whether they warrant separate 
payment under the OPPS and ASC payment systems. CMS is continuing to 
analyze this issue as the agency implements section 6082 of the SUPPORT 
for Patients and Communities Act, which requires review and adjustments 
to payments under the OPPS and ASC payments systems to avoid financial 
incentives to use opioids instead of non-opioid alternatives for pain 
management.
                         medicaid block grants
    Question. I was concerned by recent reporting indicating that the 
Administration is trying to bypass Congress and change how Medicaid is 
financed by giving block grants or per capita caps to States. This 
reporting suggests that CMS is ``drawing up guidelines'' under which 
State Medicaid programs ``would get spending limits, along with more 
flexibility to run the low-income health program that serves nearly 75 
million Americans.'' \5\
    Can you explain the nature of the reported guidance that would 
allow States to implement a block grant or a per capita cap, including 
the statutory authority you rely on to make such a change?
    Answer. The Administration is committed to empowering States and 
consumers to reform healthcare. Medicaid costs to States and the 
Federal Government are growing at an unsustainable rate and States do 
not have the flexibility they need to address the underlying drivers of 
these trends. The President's Fiscal Year 2020 Budget supports a two-
part approach to move away from Obamacare, starting with enactment of 
legislation modeled closely after the Graham-Cassidy- Heller-Johnson 
bill that include Market Based Health Care Grants. In Medicaid, this 
includes allowing States a choice between a per-capita cap or a block 
grant, and repealing Obamacare's Medicaid expansion, to modernize 
Medicaid financing and refocus the program on those it was originally 
intended to serve. The second part of the Budget proposal includes 
additional reforms to address unsustainable healthcare spending trends 
and builds upon the Graham-Cassidy- Heller-Johnson bill to make the 
system more efficient. This includes proposals to align the growth 
rates for the Market-Based Health Care Grant Program and Medicaid per 
capita cap and block grant with the Consumer Price Index for All Urban 
Consumers (CPI-U). This proposal would result in an estimated $1.4 
trillion in Medicaid savings over 10 years.
    This Administration believes strongly in the important role that 
States play in fostering innovation in program design and financing. We 
also believe that when States are held accountable to a defined budget 
they will be empowered to design individual, State-based solutions that 
prioritize Medicaid dollars for traditional Medicaid populations and 
support innovation. That is why the Administration has been looking 
into offering States the option under current authorities to innovate 
with respect to Medicaid financing; however, our guidance on this topic 
is still under development.
                           diabetes research
    Question. I am troubled by the proposal in the HHS budget that 
would cut funding for the National Institute of Diabetes and Digestive 
and Kidney Diseases (NIDDK) by more than 12 percent. Diabetes research 
from NIDDK is critical in driving forward the development of new 
treatments that improve the lives of people with diabetes.
    Given that diabetes is the most expensive chronic condition facing 
our country, can you explain why the Department felt it was a good idea 
to reduce vital funding for diabetes research?
    Answer. NIH's research plan will assure that the most valuable 
research is funded. The National Institute of Diabetes and Digestive 
and Kidney Diseases (NIDDK) leads NIH's research efforts in diabetes 
and, together with other relevant Institutes and Centers at NIH, will 
continue to support basic, translational, and clinical research on 
diabetes and its complications under the funding levels requested in 
the President's Budget, such as the programs described below. Diabetes 
is certainly an important health problem facing our country today and 
NIH will continue to support research in this area, including research 
to further the development of new prevention and treatment approaches 
for type 1 diabetes, type 2 diabetes, and gestational diabetes mellitus 
(GDM). In addition to increasing the risk of complications of vision 
loss, kidney failure, and amputation, diabetes doubles the risk for 
many other diseases, including heart disease, many forms of cancer, and 
some forms of dementia, underscoring the extensive health impacts of 
this condition.
    For example, research on GDM has shown that the disease increases 
risk of complications during pregnancy and birth for both mother and 
children and increases future type 2 diabetes risk for the mother and 
future obesity and type 2 diabetes risk for the offspring. These 
findings underscore the importance of research on GDM to improve these 
short- and long-term outcomes. Toward this goal, NIDDK is establishing 
a research consortium to recruit pregnant women in their first 
trimester to examine their blood glucose levels throughout pregnancy 
and characterize the development of abnormal glucose levels. Knowledge 
from this research is expected to lead to improved approaches for 
screening for GDM and inform the development of future clinical trials 
of interventions to decrease adverse outcomes for mothers and their 
children of future clinical trials of interventions to decrease adverse 
outcomes for mothers and their children.
    NIDDK will also continue to support studies through the Diabetic 
Foot Consortium. The goal of this research consortium is to validate 
biomarkers for diabetic foot ulcers that could be used to predict 
healing outcomes, guide treatment decisions, and monitor healing and 
response to treatment. The availability of biomarkers could foster the 
development of new therapies that can improve foot ulcer healing and 
prevent amputations.
    To continue to drive the development of new therapies, NIDDK also 
supports the ongoing development of novel preclinical models, including 
efforts to produce an ``islet on a chip.'' This chip incorporates or 
mimics diverse elements that support islets in the body, such as blood 
vessels, and thus better represents human islet physiology than 
conventional two-dimensional islets cultured on plastic dishes, for 
example. This model system has the potential to be transformative in 
terms of advancing studies in human islet biology, validating diabetes 
biomarkers, and performing drug and toxicity testing of diabetes 
therapies.
    NIDDK will continue its support of research toward developing 
improved glucose management technologies for people with type 1 
diabetes. For example, NIDDK plans to continue to support advanced 
artificial pancreas clinical trials, as well as research conducted by 
academic medical centers and small businesses to develop next-
generation diabetes management technologies. The goal of the research 
is the development of multiple devices so that people with diabetes and 
their healthcare providers can choose the technology that is right for 
them.
    NIDDK is also supporting the Glycemia Reduction Approaches in 
Diabetes: A Comparative Effectiveness Study (GRADE) clinical trial, 
which is comparing the effects of four different glucose-lowering 
medications when combined with metformin, the standard first-line 
therapy for type 2 diabetes. The results of this trial may provide 
better guidance to practitioners in the choice of medications and help 
with developing a personalized treatment program for individual 
patients.
    NIDDK is committed to advancing research in type 1, type 2, and GDM 
and to finding ways to improve the lives of individuals living with 
these diseases and their complications.
                                 ______
                                 
              Questions Submitted by Senator Tammy Baldwin
                                  onc
    Question. ONC recently released a proposed rule to implement a 
number of the provisions in the 21st Century Cures Act to improve the 
interoperability of health information.
    The proposed rules seek to improve electronic health record (EHR) 
quality by allowing providers to share screen shots to illustrate their 
concerns with certain systems. Enhancing transparency is essential to 
improving the quality and safety of patient care. However, we must 
guarantee that this does not unintentionally expose proprietary 
information that bad actors in other countries could exploit for their 
own gain or even malicious intent.
    Secretary Azar, how do we strike the appropriate balance here 
between HIT transparency and access to data while protecting US 
innovation and security?
    Answer. The 21st Century Cures Act (Cures Act) requires that health 
IT developers participating in the ONC Health IT Certification Program 
not prohibit or restrict communications regarding usability, 
interoperability, security, user experience, applicable developer 
business practices, and the way the technology is used when it comes to 
their certified health IT. This statutory prohibition recognizes that 
the sharing of these types of information is extremely important to 
address matters such as patient safety, system security 
vulnerabilities, and product performance. One resounding complaint we 
have heard from patient safety advocates is that health IT developers 
use gag clauses to inhibit the flow of essential information that could 
improve safety across systems. An Institute of Medicine (IOM) report 
found that such clauses discourage users from sharing information about 
patient safety risks, significantly limiting the ability of users to 
understand how health IT products impact patient safety. The report 
stressed the need for health IT developers to enable the exchange of 
information regarding user experiences, including the sharing of 
screenshots.\6\ Further, during a series of Senate HELP Committee 
hearings, stakeholders emphasized the lack of transparency around the 
performance of health IT in a live environment, noting that it can 
undermine a competitive marketplace, hinder innovation, and prevent 
improvements in the safety and usability of the technology.\7\
---------------------------------------------------------------------------
    \6\ IOM (Institute of Medicine), Health IT and Patient Safety: 
Building Safer Systems for Better Care (2012). Available at http://
www.nationalacademies.org/hmd/Reports/2011/Health-IT-and-Patient-
Safety-Building-Safer-Systems-for-Better-Care.aspx.
    \7\ HELP 6/10/15 pg. 12; Available at https://www.gpo.gov/fdsys/
pkg/CHRG-114shrg25971/pdf/CHRG-114shrg25971.pdf.
---------------------------------------------------------------------------
    The ONC proposed rule's approach to implementing the statutory 
requirements endeavored to address these concerns, while also taking 
into account market interests, such as innovation. The ONC proposed 
rule proposes to permit developers to limit the sharing of information 
about their products for both legitimate and reasonable circumstances. 
Specifically, ONC's proposed rule would permit, under defined 
circumstances and when certain conditions are met, health IT developers 
to prohibit or restrict communications that would infringe their 
intellectual property rights and third party intellectual property 
rights included in their health IT. However, ONC proposed that a health 
IT developer would not be able to prohibit or restrict communications 
that would be a ``fair use'' of any copyright work comprised in the 
developer's health IT. This would be true for screenshots in 
particular. Faithful reproductions of health IT screenshots are an 
important means for making accurate and coherent communications about 
the subject matters identified by the Cures Act, including safety and 
security concerns. ONC will consider all public comments submitted on 
the proposed rule in order to ensure that the final rule strikes an 
appropriate balance in carrying out statutory mandates with 
consideration of stakeholders' interests.
    The ONC proposed rule is also designed to support the increased 
electronic exchange of health information and help combat the practice 
of information blocking. It would inject competition and innovation 
into the healthcare delivery system by addressing both technical 
barriers and business practices that impede the secure and appropriate 
sharing of data. The proposed rule includes a certification condition 
calling for certified health IT developers to use secure, standards-
based APIs that facilitates patients' use of smartphones for accessing 
medical records at no cost. It also would support clinicians' ability 
to partner with third-party software developers that offer unique and 
competitive services. This would facilitate patient access to their 
electronic health information on their smartphone, growing a nascent 
patient- and provider-facing app economy. The proposed rule would 
foster innovation and competition on how patients and their providers 
can securely use and share their health data, rather than competition 
on data control.
    In recognition of the breadth of ONC's proposals and the importance 
of these rules on the healthcare industry, ONC extended the comment 
period for an additional 30 days. ONC will be considering public 
comments on all aspects of its proposals, and those comments will 
inform the final rule.
                                 ______
                                 
           Questions Submitted by Senator Christopher Murphy
    Question. Your budget states that you expect an increase in the 
number of certified trafficking victims in fiscal year 2020, an 
increase in the number of potential trafficking victims that are 
identified by the trafficking hotline, and an increase in the number of 
incoming communications received from victims and survivors of human 
trafficking by the hotline. Can you explain why you decided to cut 
funding for the Anti-Trafficking in Persons Programs even though your 
budget predicts an increase in the demand of services?
    Answer. The Department is committed to providing services for 
eligible victims of trafficking. The Budget balances the need for 
fiscal responsibility with the need to provide these services by 
including $17 million, $10 million below the fiscal year 2019 Enacted, 
to provide services for both foreign national and domestic (United 
States citizen and lawful permanent resident) victims of human 
trafficking. Funds are used to screen and identify victims and to 
provide them with services including case management, emergency 
services, and medical services. Funds also support a National Human 
Trafficking Hotline and raise awareness to prevent human trafficking. 
ACF provides services to victims of trafficking in coordination with 
the Department of Justice's Office of Victims of Crime. The fiscal year 
2020 Budget for that Office includes $83 million for both foreign and 
domestic victims of trafficking.
    Question. The SUPPORT for Patients and Communities Act included 
``Sec. 1001. At-risk youth Medicaid protection'' to prevent a State 
from terminating a young person who is otherwise eligible for Medicaid 
because he or she is in the juvenile justice system. This allows a 
young person to continue treatments and other healthcare coverage 
immediately following release.
    What is the status of Medicaid guidance to States to effectuate 
this statutory change? What type of coordination will this require 
between States, territories, and the District of Columbia, and the 
judicial system? How will the Federal Medicaid Program enforce this 
protection for otherwise eligible youth as they leave the juvenile 
justice system?
    Answer. CMS continues to make great strides in implementing the 
SUPPORT for Patients and Communities Act. Section 1001 prohibits States 
from terminating, and permits States to suspend, Medicaid eligibility 
for juvenile enrollees who become inmates of public institutions. 
States also are required to redetermine those enrollees' Medicaid 
eligibility before their release and restore their coverage upon 
release if they are eligible. States would be required to process 
Medicaid applications submitted by or on behalf of juvenile enrollees 
who are inmates in public institutions who were not enrolled in 
Medicaid before becoming inmates and ensure that Medicaid coverage is 
provided when they are released if they are found to be eligible.
    CMS is currently working on guidance to assist States in adopting 
section 1001 of the SUPPORT for Patients and Communities Act.
    More broadly, the Administration has also made historic investments 
to address opioid misuse, abuse, and overdose, but significant work 
must still be done to fully turn the tide of this public health crisis. 
The President's Fiscal Year 2020 Budget supports HHS's five-part 
strategy to:
  --Improve access to prevention, treatment, and recovery services, 
        including the full range of medication-assisted treatments;
  --Better target the availability of overdose-reversing drugs;
  --Strengthen our understanding of the crisis through better public 
        health data and reporting;
  --Provide support for cutting edge research on pain and addiction; 
        and
  --Improve pain management practices.
                                  fda
    Question. In 2016, the FDA proposed to ban electrical stimulation 
devices (ESDs) used for self- injurious or aggressive behavior because 
they present an inhumane and substantial risk to public health and they 
have been used on children with intellectual and developmental 
disabilities. This regulatory step was the result of deliberative 
discussion and consideration about the harmful nature of these devices. 
The proposed rule stated that the FDA determined that ESDs presented a 
number of psychological and physical risks, including depression, fear, 
panic, aggression, pain, burns and errant shocks from device 
misapplication or failure. Moreover, ESDs have been associated with 
additional risks such as suicidality, chronic stress, acute stress 
disorder and hypervigilance. I, along with a number of my Senate 
colleagues, wrote to then Commissioner Robert Califf to support this 
proposed ban. In addition, two dozen leading disability organizations 
and advocates also wrote in support of finalizing the proposed ban.
    Three years later the FDA has yet to issue a related final rule. 
What is the status of the proposed ban of ESDs used to treat self-
injurious or aggressive behavior?
    Answer. In the Fall 2018 Unified Agenda, FDA published notice of 
its intent to finalize the proposed rule Banned Devices; Proposal to 
Ban Electrical Stimulation Devices Used to Treat Self-Injurious or 
Aggressive Behavior (81 FR 24385), which would ban both new electrical 
stimulation devices (ESD) and devices already in distribution. The 
Unified Agenda, which was published on October 17, 2018, contains the 
top regulatory priorities of Federal agencies for the American public. 
FDA carefully reviewed the comments submitted to the public docket in 
connection with the proposed ban and associated issues and intends to 
issue a final rule in 2019. FDA has determined that these devices 
present substantial and unreasonable risks of illness or injury that 
cannot be corrected or eliminated by labeling or a change in labeling. 
Medical device safety is a key priority for the FDA, and we have sought 
to assure that the decision regarding these devices is in the best 
interests of patients.
    Question. The SUPPORT for Patients and Communities Act included a 
provision Sen. Capito and I authored, ``Sec. 7081. Program to support 
coordination and continuation of care for drug overdose patients.'' The 
program would provide those struggling with substance use disorders 
access to specially trained coaches who are in recovery themselves who 
can serve as a mentor, support for families, and help patients navigate 
treatment options. In Connecticut there is successful model that places 
recovery coaches in the emergency department. What is the status of 
implementation of that section?
    Answer. Because section 7081 was formulated as a free-standing 
provision rather than as an amendment to the Public Health Service Act, 
SAMHSA could fund the grants only if Congress added that program's 
authorization to the statutory language for SAMSHA's appropriations.
                                 ______
                                 
            Questions Submitted by Senator Joe Manchin, III
                     community services block grant
    Question. I was very disappointed to see that the President's 
Budget completely eliminated funding for the Community Services Block 
Grant. This block grant provides more than 7 million dollars to West 
Virginia to serve more than 110,000 low-income West Virginians. And, in 
2017, this funding helped my State leverage $4.35 from State, local, 
and private sources for every $1 in Federal funding. This funding is 
used to provide meals for seniors, fund early-childhood education, 
strengthen career training, and provide services for our veterans. The 
flexibility in this grant gives West Virginia to target the resources 
to those who need it the most.
    Secretary Azar, in recent years, West Virginia has struggled with 
budget deficits. We simply cannot replace these Federal dollars with 
State funding. What do you propose telling the children, veterans, and 
seniors who rely on the services that this block grant helps us 
provide?
    Answer. Continuing a proposal from the fiscal year 2019 President's 
Budget, the fiscal year 2020 budget request does not include funding 
for the Community Service Block Grant (CSBG). In a constrained budget 
environment, difficult funding decisions must be made to ensure that 
Federal funds are being spent as effectively as possible. The CSBG 
program does not use performance-based fundingdistribution formulas, 
and CSBG accounts for only 5 percent of the total funding received by 
eligible local agencies.
              state councils on developmental disabilities
    Question. Secretary Azar, I was disappointed to see that the 
President's budget completely eliminates funding for the State Councils 
on Development Disabilities. West Virginia has approximately 33,000 
people with a developmental disability, and we have the 3rd highest 
rate in the country of children needing special education. This funding 
is critically important to my constituents and to our efforts to ensure 
that every West Virginian is able to achieve independence, economic 
self-sufficiency, and inclusion in the community.
    Secretary Azar, with our State budget issues, the State of West 
Virginia cannot fill in where Federal funding goes away. Won't cutting 
these resources actually lead to greater costs in the future because 
without these supports individuals with developmental disabilities will 
have a harder time becoming independent and contributing to our 
economy?
    Answer. The fiscal year 2020 President's Budget continues funding 
for State Councils on Developmental Disabilities at $56 million. We 
agree that the State Councils on Developmental Disabilities program 
provides lifelong, significant support, by funding investment and 
innovation tailored to improving the quality of life of those with 
developmental disabilities. We are aware of the impact of the cuts and 
are eager to work with State Councils on Developmental Disabilities 
grantees to identify efficiencies in the operations of the councils to 
maximize funding for service provision.
Minden, West Virginia
    Question. Secretary Azar, as you may know, Minden, West Virginia 
has been listed as a Superfund site by the EPA since 1984 because the 
small rural community was contaminated with PCBs by an industrial 
facility related to coal mining. I am gravely concerned about the 
reports stating that cancer rates are significantly higher in Minden 
than the rest of Fayette County and the rest of the State. The National 
Toxicology Program ranks PCBs as ``reasonably anticipated to be human 
carcinogens'' and the EPA has classified PCBs as a probable human 
carcinogen. Both designations indicate that there is substantial 
likelihood that extended exposure to PCB contaminated sites could 
result in cancer. Yet, the EPA has found that PCB exposure from the 
superfund site is not responsible for these high cancer rates or for a 
cancer cluster in this small, rural Appalachia town. That is why it is 
so critical that we conduct additional research to fully understand the 
potential causal connection between PCB exposure and cancer rates.
    Secretary Azar, will you commit to directing the National 
Toxicology Program at NIH and the Agency for Toxic Substances and 
Disease Registry at CDC to promptly prioritize further research on PCB 
exposure and the link to cancer?
    Further, will you commit to ensuring that these agencies have the 
resources that they need to conduct this critical research?
    Answer. Starting in the late 1980s and again more recently, ATSDR, 
an independent agency within HHS, has worked collaboratively with the 
West Virginia State and local health departments in providing support, 
under its statutory mandate to address chemical exposure concerns in 
the Minden community.
    In 1989, the WV Bureau of Public Health requested that ATSDR 
conduct a public health assessment at the Shaffer Equipment Company 
site in Minden. ATSDR published a report reviewing environmental 
sampling and health outcome data related to exposure to PCBs. In 
addition to the 1993 public health assessment, ATSDR has participated 
in several public meetings to inform and educate the community about 
the health effects of PCBs, including two recent meetings hosted by EPA 
in 2017 and 2018. ATSDR has also summarized and published information 
on PCBs for health professionals, and has created fact sheets for the 
public to answer frequently asked questions regarding PCBs.
    Currently, ATSDR is working on a new public health assessment 
report evaluating the most recent EPA environmental data on exposures 
in the Minden community and including updated cancer statistics and 
community health reporting. ATSDR will continue to provide updates to 
the Senator as the public health assessment progresses.
                  rural health care and medicaid cuts
    Question. Secretary Azar, I am concerned about the impact that the 
President's budget request would have on access to rural healthcare. 
The budget proposes replacing Medicaid with a new Federal-State 
partnership that establishes per-person caps or fixed grants at reduced 
funding levels, and eliminates the Medicaid expansion. Let me share 
some numbers with you:
    In my State of West Virginia, uncompensated care reached $692.27 
million in 2013.The following year, after Medicaid expansion was 
enacted, the State's uncompensated care dropped 38.3 percent to $427.44 
million.
    That's because almost 200,000 West Virginians gained insurance 
coverage either on the exchanges or through the Medicaid expansion--
suddenly these rural healthcare providers were being reimbursed for 
services instead of absorbing the cost.
    I have heard from rural hospital CEOs, physicians, and other 
healthcare providers in West Virginia that these cuts would be 
devastating to rural hospitals and clinics in my State. Many of them 
would have to close leaving my constituents hours away from the closest 
emergency room.
    Secretary Azar, what is your plan to ensure that rural healthcare 
providers are able to continue to serve my constituents in rural West 
Virginia if those West Virginians lose their Medicaid coverage or 
private health insurance?
    Answer. Approximately 60 million people live in rural areas, 
including millions of Medicare and Medicaid beneficiaries. HHS 
recognizes the many obstacles that rural Americans face, including 
living in communities with disproportionally higher poverty rates, 
having more chronic conditions, being uninsured or underinsured, as 
well as experiencing a fragmented healthcare delivery system with an 
overworked and shrinking health workforce, and lacking access to 
specialty services.
    I share your concerns about preserving access to care in rural 
communities. The Federal Office of Rural Health Policy was created in 
1987 to examine healthcare issues impacting rural communities, 
including: access to quality healthcare and health professionals; 
viability of rural hospitals; and the effect of HHS's proposed rules 
and regulations, including Medicare and Medicaid, on access to and 
financing of healthcare in rural areas. The President's Fiscal Year 
2020 Budget requests $189 million for the Federal Office of Rural 
Health Policy for grants to enhance healthcare delivery in rural 
communities, conduct research on rural healthcare issues, and provide 
technical assistance, such as training and dissemination of best 
practices to rural communities and stakeholders. The President's Fiscal 
Year 2020 Budget includes proposals that target critical rural health 
activities and services such as Telehealth, Rural Health Policy 
Development, and Black Lung Clinics, and the Rural Communities Opioids 
Response Program (RCORP). The President's Fiscal Year 2020 Budget 
requests $120 million for RCORP, which supports treatment and 
prevention of substance use disorder, including opioid abuse, in the 
highest-risk rural communities.
    CMS developed the Rural Health Strategy (issued in May 2018) to 
focus on areas where the agency can better serve individuals in rural 
areas and avoid unintended consequences of policy and program 
implementation for these communities. The strategy applies a rural lens 
to new and ongoing activities of the Agency and informs the pathway by 
which CMS can achieve its rural health vision through intra-agency 
collaboration, stakeholder engagement, and the elevation of programs 
and policies that will advance the State of rural healthcare in 
America.
    This Administration believes strongly in the important role that 
States play in fostering innovation in program design and financing. 
States, as administrators of the program, are in the best position to 
assess the unique needs of their respective Medicaid-eligible 
populations, including those in rural areas, and to drive reforms that 
result in better health outcomes. The Budget returns control over 
healthcare back to the States, including replacing the Federal dollars 
currently spent on Medicaid expansion and premium tax credits with 
Market-Based Health Care Grants for States over 10 years. These reforms 
will put Medicaid on a more sustainable path for the future.
    CMS works with State Medicaid agencies and other State partners to 
advance rural health strategies for Medicaid eligible individuals, 
including people with disabilities, dual-eligible beneficiaries, and 
people with substance use disorders. We are also committed to ensuring 
that States have the flexibilities they need to administer their 
programs to fit their unique needs. CMS also has an established Rural 
Health Council, which is focused on improving access to care for those 
living in rural areas, supporting the economics of providing care in 
rural areas, and ensuring that new healthcare innovations also fit 
rural markets.
      food and drug administration's regulation of premium cigars
    Question. Secretary Azar, I commend you and your agency for your 
willingness to address and consider actionable steps in the 
comprehensive plan on tobacco that was announced last year. I am 
encouraged by the FDA's willingness to engage in a review and dialogue 
with industry on issues pertaining to the regulation of premium 
cigars--small business retail shops in my district remain very 
concerned about the regulations. Despite the agency's recent actions to 
solicit and review information on premium cigars and ultimately 
consider changing how it regulates the product, several current or 
pending requirements for premium cigar products remain in place. This 
includes the August deadlines for costlywarning labels on packaging and 
advertising. Even by FDA's own estimates, this will cost industry, 
including many small businesses, millions of dollars.
    If FDA is currently in a process that may change its approach to 
the premium cigar category, why does it not delay or suspend these 
deadlines and requirements, until it ultimately comes to a final 
decision?
    Answer. As part of the Agency's comprehensive plan for regulation 
of nicotine and tobacco, in March 2018, FDA issued an advance notice of 
proposed rulemaking (ANPRM) to provide an opportunity for the public to 
provide new information for the Agency to consider with respect to 
``premium'' cigars. In particular, the Agency sought comments and 
scientific data related to how a ``premium'' cigar might be defined and 
the patterns of use and resulting public health impacts from these 
products. The Agency is currently considering over 32,000 comments 
received in response to the ANPRM. In the meantime, all cigars remain 
subject to regulation based on FDA's previous determination that there 
was no appropriate public health justification to exempt ``premium'' 
cigars.
    Although the warning label requirements for cigars took effect last 
August, they are currently not being enforced pursuant to an order of 
the U.S. District Court for the District of Columbia in Cigar 
Association of America v. FDA, No. 16-1460 (D.D.C.). In that case, the 
court sustained the cigar warning requirements against First Amendment 
and other challenges, but enjoined FDA ``from enforcing the health 
warning requirements for cigars and pipe tobacco set forth in 21 C.F.R. 
Sec. Sec. 1143.3 and 1143.5 until 60 days after the final disposition 
of Plaintiffs' appeal.'' Cigar Ass'n of Am. v. FDA, 317 F. Supp. 3d 
555, 563--64 (D.D.C. 2018), appeal pending, No. 18-5195 (D.C. Cir.) 
(scheduled for argument October 24, 2019).
    FDA intends to comply with the court's order in Cigar Association 
of America and will not enforce the health warning requirements for 
cigars and pipe tobacco set forth in 21 C.F.R. Sec. Sec. 1143.3 and 
1143.5 until 60 days after the final disposition of Plaintiffs' appeal. 
In addition, the agency does not intend to enforce the labeling 
requirements under sections 903(a)(2) and 920(a) of the FDCA for cigars 
and pipe tobacco while the injunction remains in effect.
    In addition, with respect to assistance for small businesses, FDA 
is committed to providing assistance to regulated entities, including 
small businesses. FDA's Center for Tobacco Products has a dedicated 
Office of Small Business Assistance, which has responded to hundreds of 
questions since the deeming regulation published and continues to 
respond to questions from industry, including small businesses.
                   opioid-related infectious diseases
    Question. Secretary Azar, as you know, West Virginia has been 
devastated by the opioid epidemic. This means that we have also seen a 
significant increase in opioid-related infectious diseases. To put this 
in perspective, on an average year the United States sees roughly 1,600 
Hepatitis A cases, and West Virginia sees just 8 of those. Again, 
that's 8 total cases annually in West Virginia. Now today, in 2019, 
West Virginia is now at over 2,400 Hepatitis A cases. That's an over 
300 percent increase. In your budget, you requested significant cuts to 
programs like the National Institute on Drug Abuse. Research conducted 
at the National Institute on Drug Abuse helps to support communities 
suffering from the consequences of drug abuse, including outbreaks of 
HIV and Hepatitis A.
    Secretary Azar, can you tell me how cutting funding to programs 
like the National Institute on Drug Abuse will help in preventing 
further opioid-related infectious disease outbreaks?
    How is the Department of Health and Human Services responding to 
serious outbreaks like the one we're having in West Virginia?
    Answer. The Budget prioritizes biomedical research to confront the 
opioid crisis by targeting resources across the Department. NIH invests 
in the highest priority biomedical research to prevent, treat, and cure 
the Nation's most challenging diseases and conditions. Opioids and pain 
research within NIH receives $1.3 billion in fiscal year 2020 to 
develop long lasting preventive and therapeutic solutions to the 
opioids crisis that can be implemented across the country--solutions 
that will prevent opioid-related infectious disease outbreaks.
    State and local health departments typically lead the 
investigations of local outbreaks of hepatitis A. When requested by the 
health department, CDC can support health departments in these 
investigations by
  --communicating with public health officials from States with 
        reported cases and providing technical assistance;
  --gathering data reported by States on confirmed cases and evaluating 
        and monitoring these data from a national perspective;
  --providing support on vaccine supply and distribution and vaccine 
        response strategy development;
  --testing clinical specimens from suspected hepatitis A cases when 
        requested by States;
  --providing technical assistance and answering questions related to 
        molecular and serologic laboratory testing;
  --providing rapid assistance on the ground during outbreak 
        investigations, often through a formal request by the State 
        health department;
  --alerting clinicians, healthcare facilities, and public health 
        officials around the country about current outbreaks and 
        providing vaccine policy and clinical guidance for healthcare 
        providers; and
  --providing information to public and healthcare providers through a 
        variety of media.
      the budgeting for opioid addiction treatment (lifeboat) act
    Question. In 2017, more than 70,000 people died from heroin or 
prescription opioid overdose--that's about 130 people every day. That's 
more people dying annually from drug overdose than car crashes or HIV/
AIDS ever have in a single year in U.S. history. Unfortunately, a major 
barrier that those suffering from opioid addiction face is insufficient 
access to substance abuse treatment. In fact, between 2009 and 2013, 
only 22 percent of Americans suffering from opioid addiction 
participated in any form of addiction treatment. That is why I 
introduced the LifeBOAT Act. This bill would require pharma companies 
to pay a small fee--1 cent per milligram--on their opioid products. It 
would then direct this funding to Substance Abuse Prevention and 
Treatment Block Grant.
    Secretary Azar, will you support this commonsense proposal?
    Answer. While I cannot comment on this particular legislation, I 
certainly agree that opioid manufacturers, distributors, and 
prescribers all have a role to play in ensuring that patients do not 
fall victim to addiction. And when the system fails, patients need 
immediate access to sustained, evidence-based addiction treatment. I 
respectfully defer to Congress on the most appropriate way to fund such 
treatment.
    Question. We must increase funding for the many West Virginians and 
Americans who are struggling to recover. How do you propose we pay for 
treatment facilities to keep people from dying?
    Answer. As stated previously, I respectfully defer to Congress on 
the most appropriate way to fund treatment facilities.
                              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 bill passed in the SUPPORT for Patients 
and Communities Act last fall.
    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. The Substance Abuse and Mental Health Services 
Administration is working diligently to address the issues of sharing 
information among practitioners for the better care and treatment of 
individuals. We believe strongly that information must be readily 
accessible to providers in order to best provide holistic evidence-
based care to individuals living with substance use disorders. As such, 
my Department is working to revise the existing regulations around 42 
CFR Part 2 to remove barriers to coordinated care and permit additional 
sharing of information among providers. Our aim is to eliminate issues 
that led to the unfortunate consequence in this case. Once this 
revision is completed, the Department will provide clear training and 
technical assistance as well as clear guidelines on its implementation. 
In the meantime, we have launched a Privacy TA Center which produces 
training and technical assistance to all practitioners, individuals, 
and families on the sharing of patient information and confidentiality 
regulations.
                     the jessica grubb's legacy act
    Question. Secretary Azar, as you know, the 42 CFR Part 2 
regulations govern the confidentiality and sharing of substance use 
disorder treatment records within our healthcare system. Unfortunately, 
at a time when we are working toward greater care coordination, this 
regulation has acted as a barrier to communication between healthcare 
providers serving individuals with substance use disorders. I 
introduced the Jessica Grubb's Legacy Act in honor of a young woman 
that we lost too soon to an opioid overdose because her medical records 
did not adequately indicate her past addiction and--while in recovery--
was sent home from a surgery with 50 oxycodone pills. This bill would 
simply align the privacy standards for substance use disorder treatment 
records with HIPAA--the privacy standard that governs all other 
physical and mental healthcare records. It would preserve patient 
privacy, but ensure that medical professionals have access to the vital 
information that they need to properly coordinate the care of their 
patients with substance use disorders. As the agency that oversees 42 
CFR Part 2, SAMHSA has said that they are encouraged that Congress is 
examining ``the benefits of aligning Part 2 with HIPAA'' because `` 
healthcare providers must have secure access to patient information, 
including substance use disorder information, in order to provide 
integrated and effective care.''
    Secretary Azar, will you commit to working with me to pass the 
Legacy Act (S. 1012) to align Part 2 with HIPAA and ensure that those 
recovering from substance use disorders are able to receive quality, 
coordinated healthcare?
    Answer. The Department takes the sharing of patient information 
very seriously. We understand the need for physicians to be well 
equipped with the information they need to provide their patient the 
best possible care. The unfortunate case which prompted Jessie's law is 
a reminder of the need for physicians to have proper access to 
information. As such, HHS is working to revise the 42 CFR Part 2 
regulations to make it easier to share information while still ensuring 
patient confidentiality. The fiscal year 2020 Budget proposes that 
legislation be enacted to address this issue and enable HHS to more 
closely align the privacy regulation at 42 CFR Part 2 with the Health 
Insurance Portability and Accountability Act. I have asked my staff to 
review your proposal, and provide me advice.
               opioid funding for the hardest hit states
    Question. Secretary Azar, my State of West Virginia has been 
devastated by the opioid epidemic. We are the hardest hit State in the 
Nation and have the highest overdose death rate. Our State also faces 
the largest per-capita economic burden in the country: the opioid 
epidemic is costing our economy an estimated $8.8 billion per year, 
forcing us to dedicate the largest share of our GDP of any State to 
costs related to the crisis: 12 percent. This is a staggering cost for 
a small State like ours. That is why I pushed for and was glad to see 
the 15 percent set aside for the hardest hit states--those with the 
highest mortality rates like West Virginia. However, recent studies 
have shown that rural counties are still not getting their fair share. 
The study found a number of rural counties, including 40 of 95 in one 
State, received no direct Federal funding.
    Will you commit to working with me to ensure that rural counties 
with high mortality rates related to opioid overdoses get the share of 
the Federal resources that they need to address this crisis, including 
of Federal funding not subject to the 15 percent set aside requirement?
    Answer. I agree that rural communities are an area where resources 
to address the opioid crisis are especially needed. The Substance Abuse 
and Mental Health Services Administration (SAMHSA) has several programs 
that address this need. First, the Substance Abuse Block Grant allows 
States to identify areas of concern and address them in ways that make 
sense for their States and communities. West Virginia, for example, has 
identified prescription drugs as an area of focus for 2019. Another 
grant program, First Responders--Comprehensive Addiction and Recovery 
Act (FR-CARA), educates and trains first responders and members of 
other key community sectors to administer naloxone, an emergency 
treatment for opioid overdose. These grantees are also establishing 
processes, protocols, and mechanisms for referral to appropriate 
treatment and recovery communities. Of the 48 FR-CARA grants awarded, 
20 were set aside and awarded to entities serving rural communities 
with high rates of opioid abuse. Other opioid- related grant programs, 
including State Opioid Response, Strategic Prevention Framework--
Prescription Drugs, and Improving Access to Overdose Treatment, are 
awarded to both rural and non-rural communities. In an effort to 
distribute funds to communities, as well as States, SAMHSA has 
initiated a new funding opportunity, which will focus on community-
driven efforts to advance substance abuse prevention, allowing 
communities and counties to apply for funds directly. We expect rural 
counties to be in the recipient pool for these funds. Finally, SAMHSA 
funds 13 Rural Opioid Technical Assistance grantees, which develop and 
disseminate training and technical assistance for rural communities on 
addressing opioid issues affecting these communities. The grantees 
facilitate the identification of model programs, develop and update 
materials related to the prevention, treatment and recovery activities 
for opioid use disorder (OUD), and ensure that high-quality training is 
provided.
                                 ______
                                 
            Questions Submitted by Senator Patrick J. Leahy
                         unaccompanied children
    Question. There are allegations of sexual abuse against thousands 
of immigrant children at facilities run by private entities contracting 
with the Department of Health and Human Services (HHS). These private 
entities are engaged in fundamentally governmental functions--housing 
and caring for children in the custody of the Federal Government. 
However, these private entities are not subject to any of our Federal 
transparency laws like the Freedom of Information Act, which apply to 
government agencies engaged in the same functions.
    Do you support a proposal to apply the requirements of the Freedom 
of Information Act to private entities that contract with HHS to house 
and care for children in the agency's custody? If not, why not?
    Answer. ORR care provider facilities must report all allegations of 
sexual abuse, sexual harassment, or inappropriate sexual behavior 
immediately but no later than four hours after learning of the 
allegation. Care providers report to the Federal Bureau of 
Investigation (FBI) any allegations of sexual abuse that are subject to 
Federal reporting laws or could constitute violations of Federal law. 
Sexual abuse is defined at 34 U.S.C. 20341 and in ORR regulations at 45 
C.F.R. 411.6. Sexual abuse can include allegations such as touching of 
the buttocks or allegations of sexual assault, whether it was a minor-
on-minor or staff-on-minor allegation.
    Information about sexual misconduct is reported to ORR, the FBI, 
and HHS/OIG via a sexual abuse significant incident report (SIR). Care 
providers must submit an addendum to the sexual abuse SIR within 24 
hours of learning of incorrect, incomplete, or new information, 
including any information about a pending or complete investigation. 
ORR maintains SIRs and addendums, along with other records pertaining 
to each child in ORR custody, in an electronic database. The records in 
this database are already subject to FOIA.
    In fiscal year 2016 and 2017, care providers reported 612 
allegations of sexual abuse to the FBI. Of those 612 allegations, 105 
allegations involved a staff member at an ORR-funded care provider 
facility. In October 2017 through July 2018, care providers reported 
412 allegations of sexual abuse to the FBI. Of those 412 allegations, 
49 allegations involved a staff member at an ORR-funded care provider 
facility.
                       child sponsor information
    Question. The Consolidated Appropriations Act of 2019 contains a 
provision prohibiting the Department of Homeland Security from using 
information obtained from HHS about sponsors or potential sponsors of 
unaccompanied children to apprehend, detain, or remove such 
individuals--unless that information reveals that the individual is a 
danger to the child.
    What has HHS done to implement this provision of the law since the 
passage of the Consolidated Appropriations Act of 2019 (Public Law116-
6)? Has any guidance or memoranda been distributed within HHS regarding 
implementation of and compliance with this prohibition? If so, please 
provide the Subcommittee with copies of any such guidance or memoranda. 
If not, why not?
    Answer. As of April 18, 2019, ORR has not instituted any new 
policies related to the DHS prohibition contained in the Consolidated 
Appropriations Act of 2019 (PL 116-6), and we defer to DHS for any 
procedures it implemented to comply with this provision. HHS notes 
that, the prohibition could affect the UAC program in that some 
potential sponsors may be less apprehensive in coming forward to 
sponsor a child. However, the prohibition does not require a change to 
current ORR release policies.

                          SUBCOMMITTEE RECESS

    Senator Blunt. The subcommittee stands in recess.
    [Whereupon, at 12:00 p.m., Thursday, April 4, the 
subcommittee was recessed, to reconvene subject to the call of 
the Chair.]