[Senate Hearing 114-680]
[From the U.S. Government Publishing Office]



 
  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2017

                              ----------                              


                        THURSDAY, MARCH 3, 2016

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee me at 9:59 a.m., in room SD-138, Dirksen 
Senate Office Building, Hon. Roy Blunt (chairman) presiding.
    Present: Senators Blunt, Moran, Cochran, Alexander, 
Cassidy, Capito, Lankford, Murray, Durbin, Mikulski, Shaheen, 
Merkley, and Schatz.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                        Office of the Secretary

STATEMENT OF SYLVIA M. BURWELL, SECRETARY


                 opening statement of senator roy blunt


    Senator Blunt. Good morning. Thank you, Secretary Burwell, 
for appearing before the subcommittee today to discuss the 
Department of Health and Human Services' fiscal year 2017 
budget request. We look forward to hearing your testimony.
    We have many shared priorities in this budget proposal--
cancer research, combating opioid abuse, increasing access to 
mental healthcare. I was disappointed, however, that many of 
these investments are not part of the discretionary budget 
request, something that we want to talk about today, that I at 
least want to talk about today. This is a precarious position I 
think for the department to be in.
    The request leans heavily on new mandatory spending 
proposals that bypass the current budget caps and bypass the 
discretionary allocations in the committee. If the committee 
would follow the recommendation from the department, we would 
cut almost $2 billion for programs currently funded by 
discretionary spending in this bill and I guess you would 
expect, and the administration would expect, new currently 
unauthorized mandatory funding to fill those holes. It is one 
thing if that happens, another significant thing if it does 
not.
    My view would be that we need to figure out how to 
prioritize, that everything cannot be a priority, so this 
should be a discussion between us on the committee and with you 
as to where we need to allocate the money we have to spend in 
your department. It seems to me the department submission just 
assumes that we will solve this problem by mandatory spending 
and new resources that I have no particular reason to believe 
the Congress is likely to agree with.
    The subcommittee needs to look at what you have suggested, 
look at the cuts that would happen if we just simply would 
adopt your budget. For instance, with discretionary spending, 
we would eliminate children's hospital medical education 
dollars. That would theoretically come from somewhere else, but 
if we assume that is going to happen, there would be no 
graduate medical education in children's hospitals.
    The administration's proposed funding increases can only be 
achieved by mandatory increases. My overarching concern is that 
whether the department would truly be prepared for the budget 
you submitted if those mandatory programs do not happen.
    I think it is something we should all be very thoughtful 
about, because once we get through this process and those do 
not occur, that would mean a $1 billion cut in the National 
Institutes of Health. It would mean, as I just suggested, no 
money for graduate medical education at children's hospitals.
    So I do not agree with the approach, but maybe you can 
assure us on how that approach is going to have more success 
than I think it is likely to have.
    But I do want to complete my opening remarks by saying I 
think you bring great capacity to this job. I appreciate your 
openness to discuss these and other issues, not only here today 
but you have really been extraordinary in reaching out to talk 
about the challenges that the department faces. And I look 
forward to continuing that discussion.
    I am pleased now to recognize Senator Murray for her 
opening comments.


                   statement of senator patty murray


    Senator Murray. Thank you very much, Mr. Chairman.
    Secretary Burwell, thank you for being here today and for 
all that you do every day to improve the health and well-being 
of our families and communities across the country.
    I look forward to your testimony today and the discussion 
about the department's funding needs for the fiscal year 2017. 
While I know you are going to be highlighting the department's 
request in your statement, I do want to note how pleased I was 
to see that it proposes a significant increase for early 
learning and child care. That includes $161 million to 
implement the safety and quality improvements that were 
contained in the reauthorization of the Child Care and 
Development Block Grant, which the Senate approved 16 months 
ago with overwhelming bipartisan support, 88-1, due in no small 
part to the leadership of Vice Chairwoman Mikulski.
    And I thank you as well for that.
    Those investments really support working families and help 
make sure our kids start kindergarten ready to learn.
    I was also pleased the budget maintains support for the 
Affordable Care Act, which has expanded health insurance 
coverage to millions of people and helped a lot more families 
pay less for better quality care. We need to keep working 
toward more coverage, not less; more affordability, not less; 
and better quality, not less. That is something I know that, on 
this side, Democrats will continue to be focused on.
    Overall, there is much to like in the President's HHS 
budget request. It builds on the bipartisan spending bill that 
Congress passed late last year, a bill that was possible 
because Democrats and Republicans were able to come together 
and break through the gridlock and reach a budget agreement 
that allowed us to provide needed discretionary investments in 
NIH, CDC, worker training, child care, early learning programs, 
just to name a few.
    That agreement showed that, once again, when we work 
together to find common ground, we can deliver results to the 
families and communities we serve. I am hopeful that we can 
build on last year's momentum to do the same again this year.
    Many of the challenges facing us remain the same as when 
Secretary Burwell testified before the subcommittee last 
spring. There is still much more we need to do to continue work 
started in the Affordable Care Act to expand access to quality, 
affordable healthcare.
    The intense competition for NIH grants means that fewer 
than 20 percent of applications get funded, leaving lots of 
promising science without support.
    And the epidemic of opioid and prescription drug abuse 
continues to hurt families and communities nationwide.
    Secretary Burwell, as you well know, our broken mental 
healthcare system is yet another ongoing challenge we have to 
tackle. I know this is a priority that many members here today 
as well as on the HELP Committee share, and it is a focus for 
the administration as well.
    So I am very hopeful that the bipartisan momentum we are 
seeing on this can continue, and that we can work together on 
some solutions that expand access to quality, effective mental 
healthcare so many families are struggling to find.
    We will be challenged to find ways to address these and 
other persistent needs while also taking into account the new 
policies laid out in the Every Student Succeeds Act that 
Senator Alexander and I helped write and signed into law in 
December.
    As everyone here knows, the 2-year budget agreement rolled 
back the automatic cuts and allowed us to restore key 
investments, but it did not go as far as many of us had hoped. 
That means, as it often does, difficult choices will be 
unavoidable in 2017, as they were last year. Even so, I believe 
that our subcommittee can find a way to write a bipartisan bill 
once again. But doing so depends on this subcommittee getting 
an allocation that will allow us to make the needed investments 
in education and medical research and drug treatment and 
support for working families and a lot more. I know Chairman 
Blunt would like to work on this bill in a bipartisan manner as 
well, and build on the progress that we have made.
    So I look forward to working with you, Secretary Burwell, 
and all of our colleagues who are here today, in the coming 
weeks and months. Thank you very much.
    Senator Blunt. Thank you, Senator Murray. We do hope to be 
able to work on this bill together.
    Secretary Burwell, again, we are delighted you are here. We 
look forward to your testimony.


              summary statement of hon. sylvia m. burwell


    Secretary Burwell. Thank you. Chairman Blunt, Chairman 
Cochran, and Ranking Member Murray, and Ms. Mikulski as well, 
and all the members of the committee, I want to thank you for 
this opportunity to discuss the President's Department of 
Health and Human Services budget for this year.
    As many of you all know, I believe that all of us share 
common interests and that we can find common ground. In the 
last legislative session, this Congress made timely investments 
in programs to improve the health and welfare of the American 
people, and I thank you all and this committee for that.
    The budget before you today is the final budget for this 
administration, and my final budget. It makes critical 
investments to protect the health and well-being of the 
American people. It helps ensure that we do our job to keep 
people safe and healthy, accelerates the progress in scientific 
research and medical innovation, and expands and strengthens 
our healthcare system. And it helps us continue to be 
responsible stewards of the taxpayer dollars.
    For HHS, the budget proposes $82.8 billion in discretionary 
budget authority. Our request recognizes the constraints in our 
budget environment, and includes targeted reforms to Medicare, 
Medicaid, and other programs.
    Over the 10 years, these reforms to Medicare would result 
in savings of $419 billion.
    In order for Americans to benefit from recent breakthroughs 
in medical science, we need to ensure that all Americans have 
access to quality, affordable healthcare.
    The Affordable Care Act has helped make historic progress. 
Today, more the 90 percent of Americans have health coverage, 
the first time in our Nation's history that this has been true. 
This budget seeks to build on that progress by improving both 
the quality of the care that patients receive, spending our 
healthcare dollars more wisely, and putting engaged and 
empowered individuals at the center of their care.
    It proposes investments to improve the access to care for 
underserved groups across the United States, including many 
living in rural communities. With $5.1 billion in health center 
funding and nearly $14 billion over the next decade proposed 
for our Nation's healthcare work force, even more Americans 
will be able to get the care they need.
    By advancing and improving the way we pay doctors, 
coordinate care, and use health data and information, we are 
building a better, smarter healthcare system.
    Let me turn to an issue we have been working on here at 
home and abroad. As we work aggressively to combat the spread 
of Zika, the administration is requesting $1.9 billion in 
emergency funding, including $1.5 billion for the Department of 
Health and Human Services.
    We appreciate Congress' consideration of this important 
request as we implement the essential strategies to prevent, 
detect, and respond to this disease.
    I know the rise in opioid misuse and abuse and overdose has 
affected many of your constituents. Every day in America, 78 
people die from opioid deaths. That is why this budget proposes 
significant funding, over $1 billion, to combat the opioid 
epidemic.
    Research shows that early learning programs can set a 
course for a child's success throughout his or her life, and 
that is why over the course of this administration and together 
with congressional support, we have more than doubled access to 
Early Head Start and services for infants and toddlers. Our 
budget proposes a total of $9.6 billion for the Head Start 
program and an investment in child care services that would 
allow us to serve over 2.6 million children.
    Today, too many of our Nation's children and adults with 
diagnosable mental health disorders do not receive the 
treatment that they need. So this budget proposes $780 million 
in new mandatory and discretionary resources over the next 2 
years.
    While we invest in the safety and health of Americans 
today, we must also relentlessly push forward the frontiers of 
science and medicine. This budget invests in the Vice 
President's cancer initiative. Today, we are entering a new era 
in medical science, and with the proposed increase of $107 
million in the Precision Medicine Initiative, and $45 million 
for the administration's BRAIN Initiative, we can continue that 
progress.
    Finally, I just want to thank the employees of HHS. In the 
past year, they have helped with the Ebola outbreak in West 
Africa; they have helped millions of Americans enroll in health 
coverage; and they have done the quiet day-to-day work that 
makes our Nation healthier and stronger. And I am honored to be 
a part of their team.
    As members of this committee know, I am personally 
committed to working closely with you and your staff to find 
common ground and deliver impact for the American people.
    With that, I welcome your questions.
    [The statement follows:]
              Prepared Statement of Hon. Sylvia M. Burwell
    Chairman Blunt, Ranking Member Murray, and Members of the 
Committee, thank you for the opportunity to discuss the President's 
fiscal year 2017 Budget for the Department of Health and Human Services 
(HHS). In fiscal year 2016, the Congress made timely investments in 
programs to improve the health and welfare of American citizens, such 
as programs to address opioids abuse and expanding access to healthcare 
centers and Head Start. The fiscal year 2016 appropriation also made 
important investments in many research frontiers like precision 
medicine and research to combat antibiotic resistant bacteria. We thank 
you for your leadership on these important issues and look forward to 
building on these investments in fiscal year 2017.
    The Department has made historic strides towards ensuring that all 
Americans have access to the building blocks of healthy and productive 
lives--a priority that I know we share. Thanks to the Affordable Care 
Act, we have helped millions of Americans find quality, affordable 
insurance, and slowed the growth in healthcare costs for families and 
taxpayers. At the same time, we have worked to improve the quality of 
coverage--with more protections and benefits, like wellness visits and 
some cancer screenings now offered at no extra cost--no matter where 
you get your insurance. Alongside this work, we have responded to a 
number of national and global health challenges. In coordination with 
our partners across the Federal Government, we led a response to the 
Ebola outbreak in West Africa and prepared our infrastructure here at 
home, and have helped to unite global health leaders to prevent and 
respond to future outbreaks. We convened state leaders in our fight 
against prescription opioid misuse and overdose as part of a nationwide 
three-pronged strategy to drive progress. And we advanced the frontier 
of medicine through cutting-edge research in genomics and technology. 
Through all these efforts, we have worked to ensure the responsible 
stewardship of taxpayer dollars by taking steps to further strengthen 
program integrity, saving money for the taxpayer and making sure our 
programs deliver in the best possible way for those we serve.
    The President's fiscal year 2017 Budget for HHS builds on this 
progress through critical investments in healthcare, science and 
innovation, and human services. The Budget proposes $82.8 billion in 
discretionary budget authority, and additional mandatory funding to 
further support specific initiatives in the discretionary budget. This 
includes investments in critical priorities that I know we share--
cancer research, opioids abuse prevention and treatment, healthcare 
access, and behavioral health efforts. The Budget recognizes our 
continued commitment to balancing priorities within a constrained 
budget environment through legislative proposals that, taken together, 
would save on net an estimated $242 billion over 10 years.
         building upon the successes of the affordable care act
    The fiscal year 2017 Budget advances access, affordability, and 
quality in our Nation's healthcare system--goals that we share with 
Congress and this Committee. Through targeted investments, the Budget 
expands access to care, particularly for rural and other underserved 
populations, and supports primary and preventive care.
    Investing in Health Centers.--For 50 years, health centers have 
delivered comprehensive, high-quality, cost-effective primary 
healthcare to patients regardless of their ability to pay. Today, more 
than 1,300 health centers operate over 9,000 sites and provide 
healthcare services to 1 in 14 people in the United States, including 
to approximately 454,000 patients at 217 service delivery sites in 
Missouri and 910,000 patients at 298 service delivery sites in 
Washington. Health centers also play a role in reducing the use of 
costlier care through emergency departments and hospitals. The Budget 
invests $5.1 billion in health centers, including $3.75 billion in 
mandatory resources, to serve approximately 27 million patients across 
the country in fiscal year 2017.
    Increasing Access to Health Care for Minority and Underserved 
Populations.--The Department is investing in several initiatives that 
will improve access to care for underserved groups across the United 
States, including those living in rural areas. We know that this is a 
priority for many of you on this Committee. The Budget includes 
investments of nearly $14 billion over 10 years in our Nation's 
healthcare workforce to improve access to healthcare services, 
particularly in rural and other underserved communities. This includes 
support for over 10,150 National Health Service Corps clinicians 
serving the primary care, mental health and dental needs of more than 
10.7 million patients in areas with limited access to care. The request 
includes additional funding to place providers in rural areas and other 
underserved communities in order to expand access to treatment for 
prescription opioid and heroin abuse and to improve access to crucial 
mental and behavioral health services. In addition, the Budget will 
allow the Health Centers Program to serve an estimated 9.7 million 
rural Americans, an increase of approximately 1.5 million more rural 
patients than are served today.
    The Department also takes steps to close health disparities for 
minorities and Native Americans. The fiscal year 2017 Budget provides 
an estimated $13 billion, a $382 million increase above fiscal year 
2016, for programs and services to improve the health of minority 
communities and reduce health disparities. In addition to the 
investments in the Health Centers Program, where over 60 percent of 
patients are from racial or ethnic minorities, the Budget also extends 
$14 million in funding for the Health Career Opportunities Program to 
increase the diversity and cultural competence of the health 
professions workforce.
    The fiscal year 2017 Budget more than doubles available funding 
across the Department to help close the gap in behavioral health 
disparities experienced by American Indians and Alaska Natives through 
preventive and crisis response, an increase of $87 million above fiscal 
year 2016 for a total of $141 million. This funding would support 
targeted efforts within the Indian Health Service (IHS), Substance 
Abuse and Mental Health Services Administration (SAMHSA) and Centers 
for Disease Control and Prevention (CDC) to reduce rates of substance 
abuse, improve access to mental health services, and prevent suicide. 
The Budget also increases funding for the IHS by $402 million to 
continue progress and reduce health disparities in Indian Country, as 
well as fully funding contract support costs, which provides critical 
overhead funding to tribes who operate facilities under self-
determination and self-governance agreements. The Budget removes the 
cap on funding to Medicaid programs in the U.S. territories to better 
align territory Medicaid programs with those of States and expands 
eligibility to 100 percent of the Federal poverty level in territories 
currently below this level. This proposal would gradually increase the 
share of Medicaid costs covered by the Federal Government as 
territories modernize their Medicaid programs--providing critical 
healthcare funding to Puerto Rico and helping to mitigate the effects 
of its fiscal crisis.
    Expanding Access to Health Insurance Coverage. The Affordable Care 
Act is expanding access to care for millions of Americans who would 
otherwise be uninsured, improving quality of care for people no matter 
how they get their insurance, while slowing the growth in healthcare 
costs nationwide. To encourage more States to expand Medicaid, the 
Budget would give any State that chooses to expand Medicaid eligibility 
3 years of full Federal support, no matter when the State expands. The 
Budget also funds the Children's Health Insurance Program through 
fiscal year 2019 to ensure comprehensive and affordable coverage for 
beneficiaries as well as budget stability for States.
                   healthcare delivery system reform
    At HHS, we are focused on moving towards a healthcare system that 
delivers better quality of care, spends dollars in a smarter way, and 
keeps people healthy. The Budget advances the Department's work in 
three critical areas: improving the way providers are paid, finding 
better ways to deliver care, and creating better access to healthcare 
information for providers and patients.
    Improving the Way Providers Are Paid.--Rather than paying for the 
quantity of tests and screenings that providers order--a common 
practice--the Department is moving toward paying for the quality of 
care given. For patients, this can lead to more frequent communication 
with their care provider and fewer unnecessary trips back to the 
hospital. The Budget includes proposals to establish competitive 
bidding for Medicare Advantage payments and introduce value-based 
purchasing for certain Medicare providers. The Budget also encourages 
participation in alternative payment models through a number of 
proposals, including creating a bonus payment for hospitals that 
collaborate with certain alternative payment models. The Department has 
already committed to moving Medicare fee-for-service payments to 30 
percent in alternative payment models by the end of 2016, and 50 
percent by 2018. We believe that we are on track to meet our goal, and 
look forward to working with Congress to build on this progress.
    Improving Care Delivery.--To drive progress in the way care is 
provided, HHS is focused on improving the coordination and integration 
of healthcare, engaging patients more fully in decisionmaking, and 
improving the health of patients--with an emphasis on prevention and 
wellness. As part of that, we are focused on improving access to care 
by investing in and supporting telehealth, especially for rural areas. 
The Budget proposes to expand the ability of Medicare Advantage plans 
to deliver services via telehealth, and to enable rural health clinics 
and federally qualified health centers to qualify as originating 
telehealth sites under Medicare. By integrating face-to-face care with 
remote access care in both rural and urban areas, this proposal could 
improve care coordination, provide for more timely exchanges between 
specialists, and facilitate beneficiary access to care.
    Improving Access to Information.--In an effort to promote 
transparency on price, cost, and billing for consumers, the Budget 
supports the standardization of billing documents and elimination of 
surprise out-of-network charges for privately insured patients 
receiving care at an in-network facility. The Budget also provides 
continued investments to achieve secure, seamless data interoperability 
in order to better serve individuals, providers, and payers, including 
a funding increase and new authorities for the Office of the National 
Coordinator for Health Information Technology.
    Building Evidence to Drive Systemic Improvement.--Reforming the 
delivery system requires an evidence base of effective practices. The 
Budget proposes an increase of $24 million for health services research 
at the Agency for Healthcare Research and Quality (AHRQ) to advance and 
improve the performance of the healthcare system. For example, AHRQ 
data show that 87,000 fewer patients died in hospitals due to hospital-
acquired infections and conditions from 2010 to 2014--saving nearly $20 
billion. While we are encouraged by this progress, substantial 
challenges remain to build a health system that meaningfully involves 
patients in decisionmaking, and consistently uses high quality evidence 
to provide safe and high quality care for all.
                    keeping people healthy and safe
    The President's Budget builds on the Department's strategy to 
address prescription drug abuse, invests in crucial behavioral health 
services, and strengthens our Nation's public health infrastructure.
    Preventing Prescription Opioid Misuse and Overdose.--Prescription 
drug abuse impacts the lives of millions of people across the country--
with 78 Americans dying in opioid-related deaths every single day. The 
Budget proposes significant new discretionary and mandatory funding 
totaling nearly $1.1 billion to build on investments funded by Congress 
in fiscal year 2016 and to execute on the Department's three-pronged 
evidence-based approach to combat the opioids crisis:
  --Expanding the Use of Medication-Assisted Treatment.--The new two-
        year, $1 billion mandatory funding investment will help ensure 
        that every American who wants to get treatment for an opioid 
        addiction will be able to. These funding levels will enable 
        individuals with opioid use disorder to get treatment in fiscal 
        year 2017 and fiscal year 2018 by reducing costs, engaging 
        patients, and expanding access to treatment.
  --Improving Prescribing Practices.--The Budget invests in programs 
        that support improved prescribing practices, including by 
        supporting improved uptake of CDC's upcoming opioid prescribing 
        guidelines for providers. The Budget also proposes to require 
        States to track high prescribers and utilizers of prescription 
        drugs in Medicaid--saving $770 million over 10 years--and 
        bolsters other critical efforts to support providers with the 
        tools they need.
  --Expanding the Development and Use of Naloxone.--Responders to an 
        overdose have little time to effectively reverse the effects of 
        an opioid and save a life. To best prepare communities and 
        first responders, the Budget includes a total of $22 million 
        for programs that support the use of naloxone--a lifesaving 
        overdose reversal drug. Among other critical programs, the 
        Budget invests $10 million in the Rural Opioid Overdose 
        Reversal Grant program to target rural areas hit hardest by 
        opioid abuse.
    Expanding Access to Mental and Other Behavioral Health Care.--
Despite the expanded behavioral health coverage for millions of 
Americans by the Affordable Care Act, less than half of children and 
adults with diagnosable mental health disorders receive the treatment 
they need. To address this gap, the Budget proposes a total of $999 
million, including a new 2-year $500 million investment in mental 
healthcare, to help engage individuals with serious mental illness in 
care, improve access to care by increasing service capacity through 
certified community behavioral health clinics, boost the behavioral 
health workforce, and ensure that behavioral healthcare systems work 
for everyone. A portion of the 2-year, $500 million mandatory 
initiative will allow six additional States to participate in the 
Certified Community Behavioral Health Clinic Demonstration--established 
by section 223 of the Protecting Access to Medicare Act of 2014.
    Combating Antibiotics Resistant Bacteria.--The emergence of 
antibiotic-resistant bacteria continues to be a significant public 
health concern. The fiscal year 2017 Budget includes $877 million to 
continue expanding the Nation's ability to protect patients and 
communities by implementing interventions that reduce the emergence and 
spread of antibiotic-resistant pathogens. This funding will also 
support ongoing ground-breaking research to aid the development of new 
drugs and diagnostic products, building the Nation's treatment options 
for these dangerous pathogens.
    Investing in Domestic and International Preparedness.--The 
Department leads critical efforts to strengthen our public health 
infrastructure here at home and bolster the Nation's preparedness 
against chemical, biological, nuclear and radiological attacks. The 
Budget invests $915 million, an increase of $2 million, for domestic 
and international public health infrastructure, including funding to 
expand implementation of the Global Health Security Agenda (GHSA) to 
strengthen capacity in Phase 2 countries to address public health 
emergencies. Over the next 5 years, the United States will work with 
more than 30 partner countries--representing over four billion people--
to help them prevent, detect, and effectively respond to infectious 
disease threats. I am pleased to share that work with many of these 
countries has already begun. We appreciate the funding provided by 
Congress last year for this crucial priority.
    As we work aggressively to combat the spread of Zika, the 
Administration is requesting $1.9 billion in emergency funding, 
including $1.5 billion for HHS, to enhance our ongoing efforts both 
domestically and internationally. The requested resources will build on 
our ongoing preparedness efforts and will support essential strategies 
to combat this virus, such as rapidly expanding mosquito control 
programs; accelerating vaccine research and diagnostic development; 
enabling the testing and procurement of vaccines and diagnostics; 
educating healthcare providers, pregnant women and their partners; 
improving epidemiology and expanding laboratory and diagnostic testing 
capacity; improving health services and supports for low-income 
pregnant women, and enhancing the ability of Zika-affected areas to 
better combat mosquitoes and control transmission. We appreciate the 
Congress's consideration of this important request.
    Serving Refugees and Unaccompanied Children.--In light of a global 
displacement crisis, the Administration has committed to expanding the 
Refugee Admissions Program in fiscal year 2016 and fiscal year 2017. 
All refugees are subject to the highest level of security checks of any 
category of traveler to the United States. At HHS, the Administration 
for Children and Families' role is to link newly-arrived humanitarian 
populations, including refugees, asylees, Cuban entrants, and special 
immigrant visa-holders, to key resources necessary to becoming self-
sufficient, integrated members of American society. The Budget provides 
initial financial and medical assistance for an estimated 213,000 
entrants, including 100,000 refugees, consistent with the 
Administration's commitment to admitting at least 100,000 refugees in 
fiscal year 2017.
    In addition to serving the populations discussed above, HHS is also 
legally required to provide care and custody to all unaccompanied 
children apprehended by immigration authorities until they are released 
to appropriate sponsors to care for them while their immigration cases 
are processed. Based upon the increase in unaccompanied children 
apprehended at the Southwest border this fall, ACF has taken prudent 
steps to identify temporary capacity so that we are adequately prepared 
if additional shelter space is needed. To ensure that HHS can provide 
appropriate care for unaccompanied children in fiscal year 2017, the 
Budget includes the same amount of total base resources available in 
fiscal year 2016, as well as a contingency fund that would trigger 
additional resources only if the caseload exceeds levels that could be 
supported with available funding.
           building blocks for success at every stage of life
    The Budget request supports the Department's efforts to serve 
Americans at every stage of life, including by promoting the safety and 
well-being of our Nation's children, and helping older Americans live 
as independently as possible.
    Investing in Child Care and Early Learning.--Research has shown the 
significant positive impact that early learning programs can have on a 
child's development and lifelong well-being. The Budget proposes 
strategic investments to make affordable, quality child care available 
to every low- and moderate-income family with young children; to build 
on investments to expand access to high quality early learning programs 
including both Head Start and the newly authorized Preschool 
Development Grant program; and to invest in voluntary, evidence-based 
home visiting programs that have long-lasting, positive impacts on 
child development.
    With congressional support, the Administration's investment in Head 
Start services has more than doubled access for infants and toddlers 
over the course of the Administration, and significant investments have 
been made to strengthen the quality of services that Head Start 
provides. The fiscal year 2017 Budget provides a total of $9.6 billion 
for the Head Start program, which includes the resources necessary to 
maintain this expansion of services. In addition, the Budget builds on 
the investments made in fiscal year 2016 to expand the number of 
children attending Head Start programs that offer a full school day and 
year program, which is proven to be more effective than programs of 
shorter duration and helps meet the needs of working parents. In 
collaboration with the Department of Education, the Budget includes 
$350 million for Preschool Development Grants to support States in 
building and expanding high-quality preschool systems.
    The President's Budget continues the historic proposal to provide 
$82 billion over 10 years in additional mandatory funds for child care 
to ensure that all low- and moderate-income working families with young 
children have access to high-quality child care. This proposal will 
increase the number of children served to a total of 2.6 million by 
2026 and raise the quality of care children receive. In addition, the 
fiscal year 2017 Budget includes almost $3.0 billion in discretionary 
child care funding, an increase of about $200 million, to support 
States, tribes, and territories as they implement the new health, 
safety, and quality requirements of the bipartisan child care 
reauthorization, and to create pilots that will test and evaluate 
strategies for addressing the child care needs of working families in 
rural areas and families working non-traditional hours.
    Supporting Child Welfare.--The Department plays a critical role in 
supporting child welfare, particularly among vulnerable populations. 
The Budget includes $1.8 billion over 10 years to ensure that child 
welfare professionals have the right training and skills--proven to be 
linked to better outcomes for children across a range of measures. The 
Budget also includes a package of investments designed to do more to 
prevent the need for foster care and assist children and families so 
that children can either be reunited with their biological parents or 
placed in a permanent home.
    Supporting Older Adults.--As members of this Committee are aware, 
the population age 65 and over is projected to more than double to 98 
million in 2060. In fiscal year 2017, HHS continues to make investments 
to address the needs of older Americans, many of whom require some 
level of assistance to live independently and remain in their homes and 
communities for as long as possible. The Budget continues to propose 
reforms that help to protect older Americans from identity theft, to 
support access to counseling, respite, and nutrition services that will 
allow States to provide approximately 205 million meals to over 2 
million older Americans nationwide. The Budget also continues the 
Department's commitment to support effective Alzheimer's disease 
research, education, and outreach, as well as patient, family, and 
caregiver services.
              leading the world in science and innovation
    The fiscal year 2017 Budget builds on the historic gains the 
Department has made in medical and scientific research and lays the 
ground work for scientific and technological breakthroughs for the 21st 
century. Thanks to biomedical research, including NIH investments, 
cardiovascular death rates in the United States have fallen by more 
than 70 percent in the last 60 years. Cancer death rates are now 
falling 1-2 percent per year; each 1 percent drop saves approximately 
$500 billion. Breakthroughs in HIV therapies enable people in their 
20's to live a full life span. The fiscal year 2017 Budget includes 
$33.1 billion for the NIH, an increase of $825 million, to build on the 
funding provided by this Congress in order to advance our shared 
commitment to support research that promotes economic growth and job 
creation, and advances public health.
    Launching the Cancer Moonshot.--Investments in research have led to 
significant developments in the prevention, screening, and treatment of 
cancer. To support the Vice President's Cancer Moonshot, the Budget 
includes a multi-year $755 million initiative that accelerates the 
Nation's fight against cancer by expanding access to clinical trials, 
pursuing new vaccine technology, and funding exceptional opportunities 
in cancer research. These investments will drive scientific advances 
that aim to understand the causes of cancer, discover new prevention 
strategies, improve early detection and diagnosis, and develop 
effective treatments.
    Advancing Precision Medicine.--Recent breakthroughs in genomics, 
computing, and molecular medicine have ushered in a new era where more 
treatments are based on the genetic characteristics of each patient. 
The Budget increases funding for the Precision Medicine Initiative by 
$107 million to a total of $309 million to support critical new studies 
on therapies, and to continue to scale a cohort study to gather data on 
the interplay of environmental exposures, physical parameters, and 
genetic information.
    Investing in the BRAIN Initiative.--Despite the advances in 
neuroscience in recent years, the underlying causes of most 
neurological and psychiatric conditions remain largely unknown due to 
the vast complexity of the human brain. To further revolutionize our 
understanding, the Budget provides an increase of $45 million, for a 
total of $195 million within NIH, for the BRAIN Initiative. This 
research has the potential to discover underlying pathologies in a vast 
array of brain disorders and provide new avenues to treat, cure, and 
even prevent common conditions, such as Alzheimer's disease, autism, 
depression, schizophrenia, and addiction.
                     making the department stronger
    One of my top priorities as Secretary is to position the Department 
to most effectively fulfill its core mission by investing in key 
management priorities, including program integrity and cybersecurity. I 
appreciate the Committee's interest in these critical issues.
    Strengthening Program Integrity.--The Budget continues to make 
cutting fraud, waste, and abuse a top Administration priority by 
requesting $199 million in new program integrity investments in fiscal 
year 2017. The Budget fully funds the Health Care Fraud and Abuse 
Control (HCFAC) discretionary cap adjustment. In fiscal year 2015 alone 
the HCFAC program returned over $2.3 billion to the Federal Government 
and private citizens. The Budget includes proposals that will expand 
and strengthen the tools available to CMS and States to combat fraud, 
waste, and abuse, including in State Medicaid programs. In total, 
proposed program integrity investments and authorities in the Budget 
will yield an estimated $25.7 billion in scorable and non-scorable 
savings to Medicare and Medicaid over 10 years.
    Focusing on Stewardship.--To improve the efficiency of the Medicare 
appeals system and reduce the backlog of appeals awaiting adjudication 
at the Office of Medicare Hearings and Appeals (OMHA), HHS has 
developed a comprehensive strategy that involves additional funding, 
administrative actions, and legislative proposals. The Budget includes 
resources at all levels of appeal to increase adjudication capacity and 
advances new strategies to alleviate the current backlog. The Budget 
also includes a package of legislative proposals that provide new 
authority and additional funding to address the backlog.
                               conclusion
    Members of the Committee, thank you for the opportunity to testify 
today and for your continued leadership on these important issues. I am 
grateful to have you as partners as we make the investments critical 
for today while laying a stronger foundation for tomorrow. I want to 
conclude by thanking the men and women of our Department, who work 
tirelessly every day to deliver impact for those we serve--the American 
people. I welcome your questions.

    Senator Blunt. Thank you, Madame Secretary, for your 
comments.
    We will have time for a second round of questions, so with 
the exception of Chairman Cochran and Senator Mikulski, I am 
going to run a pretty tight clock here. They can, by the way, 
talk as long as they want to. But we will then have time for a 
second round. So hopefully we will all think about everybody 
else's time, and I will try to limit my own time in exactly the 
same way.

                   SUPPLANTING DISCRETIONARY FUNDING

    What about the question I suggested in my opening 
statement, Secretary Burwell? What if you get the budget you 
asked for and the mandatory funding that you hope happen do not 
happen? What would you have to come back and ask us to do that 
would not be happening, if you got your budget and the 
mandatory supplements do not occur?
    Secretary Burwell. So as we put the budget together, we put 
it together as a budget. We put it together in terms of what we 
think are the right needs and the right trade-offs. I think it 
is important to reflect the mandatories that we proposed are 
paid for.
    When we look at the issue of discretionary funding, as we 
think about----
    Senator Blunt. They are paid for out of noncurrent sources 
of revenue, right?
    Secretary Burwell. I think we proposed the revenue choices 
and other choices in terms of cuts. As I said, there is $419 
billion in Medicare savings that we have, and there are a bunch 
of other things that we put in our budget to do the appropriate 
savings.
    When we put forth a budget, it is about choices. And within 
our budget, we made the choices that we think we should make. I 
think it relates to the issue of the overall level of 
discretionary funding. That is something that I think, in the 
world that we live in--where we have issues like opioids, 
behavioral health, the research that we all want to do--that 
when we think that we are going to end up in a place where our 
discretionary spending as a percentage of GDP (Gross Domestic 
Product) is at some of the lowest levels we have ever seen as a 
Nation, is that where we want to be?
    So we wanted to make sure that we are abiding by the deal 
but also reflecting what we believe are the right choices in 
terms of that spending.
    Senator Blunt. The mandatory funding is paid for out of tax 
increases that the Congress would have to approve. Is that 
right?
    Secretary Burwell. There are a combination of things 
throughout our budget. Some of those are revenue issues, but 
other things are on the other side in terms of some of the 
Medicare savings. In addition, there are other things in our 
budget alone--and some may bring this up--we have actually cut 
spending on a number of things in terms of programs. And it is 
not a popular cut we do, but we have cut funding in terms of 
the CDC and vaccines that we believe are now being taken care 
of through the Affordable Care Act, because people have that 
coverage, and that there is lower demand on those programs.
    So we put together a combination of things to pay for those 
investments that we believe are necessary for the country's 
health.

                            OPIOID EPIDEMIC

    Senator Blunt. On opioids, we increased spending last year 
by almost 300 percent. I think we got slightly above the number 
that you asked for. I think we went from about $31 million or 
$32 million to $123 million, which was a big increase. I think 
your proposal here is $1 billion more over 2 years?
    Secretary Burwell. Yes. It would take us to $1.2 billion. I 
think in the area of opioids, it is related to an issue that I 
know you have been an incredible champion on, which is 
behavioral health. We all know that one of the issues around 
behavioral health is that it is actually paid for at the State 
and local level.
    In terms of the capacity, one of the things that is most 
important in a strategic approach for opioids is medication-
assisted treatment. That needs to occur on the ground in the 
communities in States like our home State of West Virginia, and 
all across the Nation.
    So the idea that we are going to be able to provide the 
capacity for treatment for the numbers of people we have is why 
we have proposed the increase.
    The vast majority of the increase that we proposed in 
opioids is for medication-assisted treatment that will go to 
the States and local communities.
    Senator Blunt. Just to help us make that case a little 
better, as we discuss it, what is your view of what has 
happened. This is a problem that we were allocating $31 million 
to 18 months ago and one that we would now be looking at 
something in the neighborhood of a half billion dollars a year?
    Secretary Burwell. I think it is the demand and the need. 
When 78 Americans are dying every day, I think we are at a 
point where it is a crisis in our Nation. I think you know, 
when I got to the Department, I asked for an evidence-based 
strategy to build on the work that we had been doing with very 
specific areas of focus that could have measurable results with 
regard to the reduction in the number of addictions and 
reduction in the number of overdoses and a reduction in the 
number of opioid deaths.
    That strategy had three parts to it, and one of the parts 
is costly, but I think the more conversations we have--I know 
you all are having them with law enforcement officials, that 
they have become the healthcare and social services system. So 
we have to have a place for those folks to go, and we have so 
many of them now that the needs are great.
    Senator Blunt. Senator Murray.
    Senator Murray. Mr. Chairman, I know that the vice 
chairwoman has to leave to go chair another committee, so I am 
happy to switch spots with her and let her go first.
    Senator Mikulski. Thank you, Senator Murray.
    There is a lot going on today. In addition to the Labor-HHS 
hearing with this fantastic attendance, CJS will be meeting in 
30 minutes, and MilCon-V.A. is also meeting.
    So I want to thank Senator Cochran for really mandating 
such a quick-paced schedule that we have our hearings and do 
our job and look forward to, again, working with both he and 
Senator McConnell to follow the budget agreement, get our 
302(b)s and get going. So thank you very much for your 
leadership.
    Secretary Burwell, we do want to thank you for your 
leadership and the way you have run the department. I think you 
brought stability to the work force, confidence in the 
Congress. Your responsiveness to us I think is very much 
appreciated.
    As we look at President Obama's last budget, we know what 
your agency does, with its 73,000 people, touches every aspect 
of American lives. We need to be able to do what we need to do 
to really be able to help American lives.
    I have to my right a champion of NIH, as so many of us are 
here, the chairman, the vice chairman of this committee. We 
have to recognize that the defense of the needs of our country 
are not only in the Defense Department, and this is why we need 
to look at domestic discretionary spending and maintain parity 
with those two.
    We are going to get to my questions. Senator Murray and I 
conferred. She will be asking a lot of the questions that I 
have in mind, like the opioid issue, the early childhood issue, 
and so on.

                           ZIKA SUPPLEMENTAL

    Let me get to the Zika supplemental. The chairman raised 
the issue of his concern about mandatory funding. I am 
concerned about that, too, and what could get cut. But you 
know, we just had a robust debate yesterday on a supplemental 
on opioids offered by Senator Shaheen. You have here before us 
the Zika supplemental. I am concerned that we just do not have 
enough to meet the emerging needs of our country.
    And with the Zika supplemental, one, is it a big threat? 
And number two, why can't we use the money that has been left 
over from Ebola? And number three, is it that we really need to 
look at CDC in the same way we have to look at our preparedness 
for a bio-attack, a chemical weapons attack, and so on?
    We have to come to grips with the Zika supplemental. I 
talked to Dr. Frieden, Dr. Fauci.
    Dr. Fauci, we are turning to him once again. We are 
grateful to have him at NIH. But he is grateful to have our 
help.
    So could you comment on the Zika supplemental? Is this the 
way we are going to do government, mandatory spending, 
supplementals? Or do we need an appropriations that America can 
count on and its Secretary can count on?
    Secretary Burwell. With regard to that broader question of 
where caps should be for discretionary funding, I could wear my 
old hat at OMB and we could discuss. And I certainly have 
opinions, but I will address directly this Zika question.
    On the issue of Zika, every day I get a report, and we have 
more and more people. We have now in the United States more 
cases confirmed of sexual transmission. When we think about 
Zika, and thinking about it at your level, I think there are 
three very important things to focus on. I think right now our 
most important focus is on making sure that fewer pregnant 
women get Zika and have the consequences of babies with very 
serious birth defects, microcephaly.
    So, one, we need to protect those pregnant women.
    Number two, there are many knowns and unknowns. Right now, 
as I am sure Dr. Frieden and Dr. Fauci have shared with you, we 
do not know the answers as to how quickly this spreads, in 
terms of whether or not it stays in semen for an extended 
period of time, or how long that is. So right now, we have to 
give guidance telling pregnant women to be extremely careful.
    We do not know what point in a woman's pregnancy that it 
has impact. There are many unknowns.
    The money we are asking for is to make sure we can do the 
research and prepare the homeland. Right now, Puerto Rico has 
cases that are transmitted in Puerto Rico, not travel-related 
cases.
    So with regard to the issue of Zika, the money and the 
needs are urgent as we prepare our Southern States especially 
for the summer for a mosquito that can breed in a capful of 
water, that is indoors, and can bite four people in one meal.
    So we are working very hard and have a plan to do that. The 
funding needs to come and is time-sensitive.

                                 EBOLA

    Senator Mikulski. Why can't you use the money that is left 
over from Ebola? That has been my position.
    Secretary Burwell. With regard to the issue of the Ebola 
money----
    Senator Mikulski. In other words, why do we need a 
supplemental?
    Secretary Burwell [continuing]. I think it is important to 
reflect that the monies that are left are for very important 
things.
    In Sierra Leone, after it had been declared transmission-
free, 48 days later, we found another case of Ebola on a dead 
body, because we were still swabbing, testing the dead bodies. 
That is how we found it, and that is why we did not have 
another large outbreak in Sierra Leone after we had been told 
we did not have any cases.
    This is a disease where we are not done.
    In addition, a big portion of the money is for Global 
Health Security Agenda. That is money Congress gave us. You 
told us to put together 5-year plans to make countries meet 
their marks before we would put the money out.
    We have worked with those countries. They have put together 
those plans, and we are going to put the money out on that 
timetable.
    It is important, because right now in Nigeria, there is a 
Lassa outbreak. Lassa is related to Ebola. It is not the same 
disease, but similar.
    Last year, I did not come to talk to you all about it, but 
we had the most cases of the Middle East Respiratory Syndrome, 
which is even quicker to spread--respiratory--outside of Saudi 
Arabia. It was in Korea. We were able to handle it because we 
were prepared.
    That Global Health Security Agenda money and those 
countries' preparedness is our preparedness, because we are 
only as prepared as that weakest link. And we do not know where 
it is coming from. MERS, we have had a case in Indiana 2 years 
ago.
    We are in a world where it is our own domestic security 
that we are concerned about.
    Senator Blunt. The chairman of the full committee, Chairman 
Cochran.
    Senator Cochran. Mr. Chairman, thank you very much. This is 
an excellent hearing.
    Madam Secretary, we appreciate your cooperation with us in 
reviewing the options for the funding levels in the bills that 
come under the jurisdiction of our committee. It is a big 
responsibility. It is a big problem, and States like mine, 
where we have a higher number of people who have a hard time 
getting access to and affording and paying for healthcare or 
hospitals or doctor fees or education programs.
    There are a lot of places where we can do a lot of good in 
helping to make life more tolerable and enjoyable. That is what 
really moves us.

                       CRITICAL ACCESS HOSPITALS

    We get tangled up sometimes in the procedures and forget 
what the big picture is. But money, for example, like critical 
access hospitals, I am disappointed that the administration is 
not requesting more funding for those facilities, where those 
facilities are less than 10 miles away from the nearest 
hospital. I hope we can look for opportunities to be more 
sensitive and generous, and that means stretching dollars and 
providing the bulk of the money where people would not have 
access.
    So what is your response to that? Are we doing the right 
thing? Are we overdoing this? Are we denying emergency services 
in life-and-death situations?
    Secretary Burwell. So with regard to the issue of critical 
access hospitals, I think it falls into the larger category of 
rural health in America. That is something I am specifically 
focused on too because where I am from, in terms of being from 
West Virginia.
    So there are a number of things in our budget that we are 
doing to focus specifically on how we are supporting those 
rural hospitals across the country. One of the things is our 
proposal on community health centers. Thanks to all of you for 
your support previously on this issue, because those community 
health centers are disproportionately in the communities that 
we are talking about. 38 percent of them are in rural America.
    In addition, the proposal that we have in front of us will 
increase the number of those with the same dollars from last 
year, but we will be able to increase the numbers.
    In addition, our National Health Service Corps, 40 percent 
of the National Health Service Corps serves rural America. We 
have proposed to increase the number of people that will be 
serving there.
    In addition, our proposal and some of the proposals we were 
just talking about in the area of opioids are specifically 
targeted to rural America. We also have some telemedicine 
proposals that I think will particularly help rural America.
    And I will say, in many States, the expansion of Medicaid 
has made a huge difference to hospitals. What we see is that 
the majority of hospital closures, and especially those rural 
hospital closures, are closing in States where expansion has 
not occurred.
    There are many things that contribute. As we know, it is 
about providers. It is about population density. But we are 
already seeing those statistics. So those are a number of 
things.
    With regard to the specifics of the critical access 
hospital issue, I think we believe those hospitals will still 
receive disproportionate Medicare payments, and our analysis 
says that hopefully that will be something that can help them.
    Senator Cochran. I appreciate very much your personal 
attention to that challenge.
    Thank you, Mr. Chairman, for providing these increases that 
we are submitting in our committee.
    Senator Blunt. Thank you, Chairman.
    Senator Murray.

                      PRESCHOOL DEVELOPMENT GRANTS

    Senator Murray. Thank you very much.
    Secretary Burwell, I really was pleased to see that you 
have requested $100 million increase for preschool development 
grants. As you know, the bipartisan Every Student Succeeds Act 
marked for the very first time that our Nation's primary 
education law authorized dedicated funding to improve access to 
preschool for children from low-income and disadvantaged 
families.
    Now, the program will be funded at HHS, but it is going to 
be jointly administered by HHS and the Department of Education. 
The Department of Education has done great work in 
collaboration with you to help States develop and sustain 
strong early learning programs.
    I wanted to ask you how is HHS planning to take advantage 
of the expertise at the Department of Education with regard to 
its early learning programs?
    Secretary Burwell. We plan to work on the relationship that 
we have had historically in this specific area in terms of how 
we have jointly worked on it before when it was sitting at 
Education, as well as how we work on a number of issues, 
whether that is joint letters in the space that the Secretary 
of Education and I do regularly in terms of when we want to 
communicate or do policy efforts.
    In order to make it so that it is more formal in terms of 
making sure that we are going to follow that path and that 
there are set parameters, we are actually working on a 
memorandum of understanding, so that when the programs 
switches--not in this fiscal year, but the next fiscal year, as 
directed by Congress--when it moves to us, there is a 
memorandum of understanding that will lay out specifically the 
ways that we ensure that we are getting appropriate input from 
our colleagues and run the program in a joint fashion.
    Senator Murray. So you will be working in lockstep with 
them?
    Secretary Burwell. Yes. That memorandum of understanding is 
something we will develop together, so that we put in place 
processes that are formalized, because we want to build on what 
I think has been more informal. But we would like to go ahead 
and formalize it, because we think that will help us make sure 
we succeed.

                         UNACCOMPANIED CHILDREN

    Senator Murray. Great. Thank you.
    As you know, there was a surge late last year in the number 
of unaccompanied children crossing our southern border and 
referred to the custody of HHS. Your department has used the 
resources this subcommittee has provided to find temporary bed 
space for those children should this trend continue.
    Yet at the same time, the Associated Press and the Senate 
Committee on Homeland Security and Governmental Affairs found 
that your department did not adequately protect these children 
after they were released to sponsors. Some of those children 
were victims of abuse, neglect, and human trafficking.
    In my view, HHS should be doing more than just finding bed 
space for these children. Can you talk a little bit about what 
changes in policies you have instituted since these stories 
came out, that will help make sure that these vulnerable 
children are protected?
    Secretary Burwell. Yes. The safety of these children is our 
priority. As you know, that is our role in this process. We are 
tasked with placing the children as quickly as possible in safe 
settings.
    I think it is important to reflect what they were looking 
at is a case in Ohio. That is a case where people broke the 
law. As soon as we had any knowledge of that, we started 
working with the Justice Department quickly to make sure that 
we worked to prosecute to the fullest extent of the law with 
those children. It is an awful situation that should not happen 
again.
    There were other accusations that a whistleblower made. We 
looked into them. Our IG (Inspector General) has looked into 
them. Our IG found that there was no substantiating evidence 
that they had in front of them with regard to that.
    Having said that, we have put in more what we consider 
policies that will help address some of the issues to make sure 
we are doing as much as we can. One, any adult in the home 
where a child is being placed will go through a background 
check. In any place where a child is placed in a nonrelative or 
a distant relative setting, those are places where we are going 
to work hard to make sure we are doing appropriate checks, some 
of those even in the home and making sure we do home visits. In 
addition, for anyone that is placed in a nonfamily member 
setting, there will be follow-up services.
    We have put in place an 800-number for the children 
themselves, if they have concerns, so they can reach out.
    One of the things about the funding though, and we had this 
conversation last year, why we would actually like flexibility 
in the funding is because we do not know the numbers and they 
fluctuate. I think you all know it was 17,000 children in the 
first quarter of this year. We have to make sure we have 
funding to get the children off the border and have the beds.
    The contingent fund that we have proposed would allow us 
the flexibility to make sure that we know that we could provide 
beds, but at the same time could think about other ways we can 
enhance services. Right now, we are doing all of those things. 
I think the question of us doing more is related to funding.
    Senator Murray. Thank you.
    Thank you, Mr. Chairman.
    Senator Blunt. So the list I have, we will start with 
Senator Alexander, then Senator Merkley, Senator Capito, 
Senator Durbin, Senator Moran, Senator Shaheen, Senator 
Cassidy, Senator Lankford.
    Senator Alexander.
    Senator Alexander. Thanks, Mr. Chairman.
    Madam Secretary, first, let me thank you for the way you 
work with the committee and with me and our office. Some of us 
here in the Senate are in the results business, and a lot of us 
are on this committee, and we like working with a Secretary who 
works the same way, so thank you for that.
    I have given you a letter about the so-called Medicaid 
bump-up. I do not want to take my time with it here, but it 
comes from our entire delegation. I believe there may be some 
unintended consequences from a well-intended effort to 
encourage more doctors to see Medicaid patients. So if you 
would look at that, I would appreciate it.
    Secretary Burwell. I will look into it.
    Senator Alexander. Madam Secretary, I want to talk about 
one subject. I want to ask for your advice and as much support 
as you can give to the idea.

                     PRECISION MEDICINE INITIATIVE

    This is an exciting time for science. Many of us believe 
that here. There is an opportunity to help almost every 
American with biomedical research. The President is for a lot 
of things but among the few things he is really for is his 
Precision Medicine Initiative. I know that, and I talked with 
him about it a year ago. I attended his Precision Medicine 
events, and I pledged to him that I would do my best to help 
him create an architecture here in the next year that will put 
us on a path toward the Precision Medicine, personalized 
medicine, that he correctly talks about.
    So the budget throws us a little curve. Senator Blunt 
talked about that. It is not surprising. I mean, it happens 
every year, really. For example, the Army Corps of Engineers, 
the administration know we are going to put money back in, so 
the administration cuts it way back.
    But the idea that you would, in the discretionary fund 
after we worked very hard--Senator Murray, Senator Blunt, 
Senator Durbin, several of us--to have a significant increase 
in discretionary funding to get on a path toward better funding 
for the National Institutes of Health and you come in with a 
lower amount of money in discretionary funding with the hope 
that somehow some committee might authorize mandatory funding 
or pass new taxes or something else, that is not very 
encouraging.
    So since we are in the results business, let me suggest a 
path forward, and I will try to do this quickly, so you will 
have a little time to answer.
    The most important legislation in the committee that 
Senator Murray and I chair is our biomedical innovation 
legislation. It is a companion to the House 21st century cures 
legislation. We have talked about it many times.
    We are moving very well on it. We have 50 proposals that 
are bipartisan, and we hope by early April to approve those in 
the committee in a bipartisan way.
    That is a train that should get to the station for the 
Precision Medicine Initiative, the Cancer MoonShot, electronic 
medical records, and anything that has to do with mandatory 
funding for NIH. The only way I can see to get that there is to 
approve these 50 proposals, most of them. That would be one 
vehicle. And that would be bipartisan. I think we can do that.
    The second vehicle would be a bipartisan consensus on 
mandatory funding. I think about it a little differently than 
just a big block of money. I want to see this committee 
continue to increase our discretionary funding. I would like to 
see the mandatory funding not be a substitute but to be in 
addition, a surge of funding for such things as Cancer 
MoonShot, Precision Medicine, and Big Biothink.
    I think we could agree on that, find a way to pay for it, 
and take those two bills to Senator McConnell, the 50 proposals 
and the bipartisan proposal on mandatory funding in mid-April. 
If we did that, I believe he would put it on the floor. I 
believe we would pass it. I believe we could merge it with a 
House bill. And the President would gladly sign it, because it 
has so many things that are important to the future of our 
country.
    Now my question is, will you help us figure that out, 
particularly with your budget background? And do you have any 
advice?
    Secretary Burwell. So I think we are completely aligned, 
and I think you know, and we have had the conversation with 
members of this committee, about the idea and the work on the 
companion to 21st Century Cures here in the Senate. And we are 
very appreciative for the work you are doing, especially in 
electronic health records. We did an announcement on that as 
recently as Monday that I think very much aligns with the 
legislation that you all are considering blocking.
    So that whole range of substantive issues that you are 
focusing on, I think we are aligned on. We want to continue to 
provide any technical assistance that we can and support for 
figuring out how you get a companion that could be conferenced. 
I think it is great that you are focused on the issue. I know 
these are complicated issues, but the idea of mandatory funding 
as the means by which we can move forward on these incredibly 
important things--you listed them, Precision Medicine, the 
issue of as we think through NIH, cancer----
    Senator Alexander. Young Investigators, perhaps.
    Secretary Burwell. I think it will probably also touch on 
the BRAIN, in terms of----
    Senator Alexander. Yes, absolutely. The BRAIN Initiative.
    Secretary Burwell. So I think what I pledge to do is work 
with you and the committee on figuring out how we can.
    I understand the tough questions on what mandatory 
discretionary caps, how we do this. I think what we want to do, 
and what we are excited to do, there is agreement. These are 
priorities for the Nation. And so how we can figure out ways to 
get that funding, and to get the legislation, because that is 
the other part of what you are speaking about on things like 
blocking, on things like making sure that we can do our 
investigations at NIH in more efficient ways, those are all 
things that we are excited to work on.
    Senator Alexander. Thank you, Mr. Chairman.
    Senator Blunt. Senator Merkley.
    Senator Merkley. Thank you, Madam Secretary.
    Thank you, Mr. Chairman.

                           CHILDREN'S HEALTH

    I want to raise two issues related to children's health. 
One is a topic that I probably have had more discussions about 
than anything else. And it will not surprise you that I wanted 
to check in on the deeming rule.
    The thing that concerns me so much is that, between 2013 
and 2014, use of e-cigarettes by our middle schoolers and high 
schoolers tripled. Addiction to nicotine is a pathway to a 
lifetime of disease, a huge impact on quality-of-life for our 
children, huge cost to the healthcare system. We have the 
potential to do it differently.
    But the rule has to emerge someday. While it is not 
emerging, more and more children are being targeted by the 
fancy flavors, the candy flavors, so on and so forth.
    Is there any hope?
    Secretary Burwell. Yes. In terms of moving the rule, I 
think you know it had 135,000 comments, a complex rule with a 
number of different pieces and parts to it. The one we are 
focused on, e-cigarettes, certainly I think is the anchor 
portion of the rule.
    It is something that we will move. I feel confident that 
this will occur. With regard to the specifics of the timing, I 
am not sure that I can predict that. I think you know we do 
rulemaking in partnership. So we will continue. I think you 
know, and you and I have discussed my intent to make sure that 
we do that.
    At the same time, a number of steps have been taken in 
addition. For the first time, we have actually done a no-sale 
order on tobacco where we have providers who are not abiding by 
the regulations. For the first time ever, we have said that 
there will be providers who, because they have gone through a 
number of times not abiding by the law, that they can no longer 
sell.
    In addition, I think you also know, with regard to liquid 
nicotine, that we have an NPRM (Notice of Proposed Rulemaking) 
that we are working on to continue to move forward.
    So there is that rule. There are the other pieces that we 
are continuing to work on in this space.
    Senator Merkley. I know you have a lot of issues you are 
concerned about, and this is one you do care about. I know it 
is out of your hands in terms of OMB, but it is still in 
partnership with your department. It is the potential for an 
important healthcare win, so please stay at it, as you have 
been.
    Secretary Burwell. I will.

                              HIV NETWORK

    Senator Merkley. Thank you.
    Second, I want to turn to the HIV network. There is a group 
of 18 research sites that participate in the HIV research 
network that was established in the year 2000. It collects data 
on 25,000 children, adolescents, and adults with HIV from 
across the United States. Together, these sites provide a 
unique source of information on delivery, disparities, cost-
effectiveness, the quality of HIV care. It has helped to get a 
lot of insights about how we can address this disease more 
effectively. Oregon Health Sciences University is one of those 
18 sites.
    This particular network is slated for elimination in the 
2017 budget, which I think caught many of us by surprise. So I 
just wanted to check in with your team. My impression is that 
the valuable insights of tracking this disease and the routes 
it is taking, so on and so forth, has contributed a lot to 
treatment and care management.
    I am hoping you can take a look at it and see if we get 
your support to keep this network alive.
    Secretary Burwell. I will look into this one. This is one I 
am not familiar with, in terms of the change, so I will look 
into it.
    Senator Merkley. Thank you.
    And I will just close with a comment. I appreciated the 
ongoing funding for the National Institute of Nursing Research. 
The NINR typically allocates about 7 percent of its budget to 
research training to help develop more researchers who often 
serve as future nurse faculty, which is facing a growing 
shortage. They sometimes are able to address some of the pieces 
that get left out of pure disease, science side--end-of-life 
events, directives, bedside support, so on and so forth, 
palliative care. I appreciate that the budget does provide $146 
million to continue the institute. Thank you.
    Secretary Burwell. Thank you.
    Senator Blunt. Thank you, Senator Merkley.
    Senator Capito.
    Senator Capito. Thank you, Mr. Chairman.
    Welcome to the Secretary, my fellow West Virginian. We are 
very proud of you in West Virginia. I think that I said that 
last year, and it continues to be so. Thank you for your great 
representation and for your great communication with all of us.

                                OPIOIDS

    I have a couple things quickly. President Obama came to 
Charleston, West Virginia, to talk about the opioid issue. You 
have put a lot of emphasis on it. You have mentioned this 
medical-assisted treatment, greater emphasis in the budget on 
that. Some of it is targeted toward rural areas. Am I correct 
in that?
    Secretary Burwell. That is correct. We already, in our 
current funding that we have that you gave us last year, 
communities with high need, and many of those are rural, so we 
are using existing funds to do some of that targeting as well.
    Senator Capito. The budget that was bumped up in December 
with I believe it was an additional $100 million, have those 
dollars been spent yet? We are working a bill through the 
Senate right now.
    Secretary Burwell. With regard to that, those monies are 
going against the three priorities that we have articulated. 
One is medication-assisted treatment. The second is making sure 
that we do the appropriate work on prescribing. CDC, I think 
you know, is about to issue new guidelines. We want to make 
sure those guidelines get to the right people. The third area, 
and this is where money is moving right now, is naloxone and 
Narcan. So when you get to that situation where a person has 
overdosed, we can try to save their lives.
    Senator Capito. On the prescribing issue, I have been 
working on an amendment to have the protocol set up for acute 
pain, so if you have a toothache or something, what are 
protocols for pain medications on that?

                              ALZHEIMER'S

    Alzheimer's is another area of interest for me, just 
formerly being a family caregiver for both of my parents, it is 
emotionally challenging, and it is very expensive. I do not 
think the training is in place. What kind of arenas are you 
going into to try to help families and caregivers who are not 
really trained for this to meet this enormous challenge?
    Secretary Burwell. There is the money that is at NIH that 
is more focused on the science, which I think gets to a little 
bit of the caregiver issues in terms of, if we are better able 
to do prevention and care for the individuals.
    But the piece in terms of the caregivers themselves is more 
at the Administration for Community Living. Last year, at the 
White House Conference on Aging, I think it is every 5 years, 
maybe every 10. But last year's conference, we spent a lot of 
time, and we actually did regional meetings across the country. 
This was one of the issues that we focused on, both in terms of 
getting input for what would be the agenda when we came to 
Washington, D.C., but also trying to make sure that we are 
putting out as much information as we have as easily as we can.
    But it is a place where I will say I think we can do more 
and better.
    Senator Capito. Yes, I would say, definitely. As the 
population ages, it hits every family. It is very difficult.
    I think the BRAIN Initiative is terrific. I know West 
Virginia University is participating in part of that, and I am 
very pleased about that.

                                HOSPICE

    The other issue I wanted to talk to you about was hospice. 
I am not sure, I think we have written to you. We understand 
the need to audit Medicare providers, but some of our hospices 
have a backlog of appeals at the Office of Medicaid Hearings 
and Appeals, for hundreds of thousands of dollars. The local 
hospice in my area, you are holding like over $1 million worth 
of payments while they go through the appeals.
    That is difficult on a nonprofit organization that I think 
really has great services.
    Is this a function of not enough administrative law judges? 
What is the backlog here?
    Secretary Burwell. So the backlog that we have in Medicare 
appeals is related to a number of issues. It is related to 
administrative law judges. We asked for the funding. We put 
together a three-part strategy to reduce the backlog.
    Number one is administrative actions that we can take to 
create a process that works more quickly. We have taken those 
steps.
    Number two, we have legislation. And on the Senate side, 
the Finance Committee actually has passed portions of that 
legislation. We need statutory changes. It would be helpful to 
get that.
    And the third is money so we can actually increase our 
numbers of administrative law judges.
    Senator Capito. Have you asked for that in this budget?
    Secretary Burwell. We have. We have.
    Senator Capito. Lastly, you have mentioned two or three 
times about a $419 billion savings in Medicare. When I was 
looking through your statement, I noticed that you referred to 
alternative payment models. What is an alternative payment 
model, simply?
    Secretary Burwell. An alternative payment model is 
sometimes called an accountable care organization. These 
alternative payment models are places where we pay for value, 
not for volume.
    So what that means is, instead of paying for the number of 
services, you pay for an episode of care or the result for the 
individual. We do that in working with providers and insurers 
and others across the country.
    The Center for Medicare and Medicaid Innovation is where we 
do these demonstrations and experiments. We are already seeing 
results. We have seen over $400 million in savings in terms of 
these accountable care organizations.
    So they focus on, you get the benefit if you get well 
people, and you treat them for their wellness and the results, 
versus service by service.
    Senator Capito. Well, we will have to have an extended 
discussion on that. It is very complicated.
    Thank you very much.
    Secretary Burwell. Thank you.
    Senator Blunt. Senator Durbin.
    Senator Durbin. Thanks a lot, Mr. Chairman.
    Madam Secretary, thanks for being here. In this room at 
this table sit some people who have done some amazing things in 
this year's spending when it comes to medical research. And I 
give special credit, of course, to the chairman and to Senator 
Murray on this committee, Senator Alexander on the HELP 
Committee.
    Virtually 5 percent real growth at the National Institutes 
of Health. It is a shot in the arm and an encouragement to 
medical researchers that we are serious about our commitment to 
biomedical research.
    CDC, similar increases. I think CDC is our Nation's first 
line of defense when it comes to national health security. We 
should start describing it as such, because day in, day out, 
year in, year out, that is their mission.
    I was disappointed with your budget. I will accept Senator 
Alexander's analysis that sometimes you cut in areas where you 
know Congress is going to step in and fill the void. I hope 
that is the case here.
    But what the chairman said at the outset, counting on 
mandatory spending to make up the difference is a risk I hope 
we never take. We should do our part on the discretionary side, 
and hope, as Senator Alexander described it, that we can 
supplement that with some commitments on the mandatory side.
    I just think we make a serious mistake--and Dr. Collins has 
told me as much; I am sure he has told you--if we do not have 
constancy in our commitment to biomedical research. There is 
just a real question by researchers as to whether they ought to 
take the risk and continue in the field, if there is 
uncertainty about funding in the future.
    So I am looking forward to working with you and Senator 
Murray who bridges both committees, HELP and the Appropriations 
Subcommittee, and Senator Blunt, to achieve that goal.

                           PRESCRIPTION DRUGS

    I would like to ask you, if I might, on the issue of 
opioids and heroin, 80 percent of heroin users start with 
opioid prescription drugs. That is a number that has been 
repeated many times. I would like to ask you about two things.
    What is the responsibility of pharma when it comes to this 
current challenge? They are generating, I am told, 14 billion 
pills a year, opioid pills, enough to provide a 1-month 
prescription to every adult American. Clearly, they are 
flooding the market with product.
    That has to be part of our calculation about why we find 
ourselves in the position we are in.
    Secondly, what are we doing in this world of pain 
management? You and I have talked about this on the phone. 
Understanding physicians have a responsibility when it comes to 
pain management, understanding it is a subjective statement as 
to whether I feel good or do not feel good, I think there is 
still a question that should be raised as to whether there is 
proper management by the physician when it comes to pain.
    Handing someone 40 or 50 pills, as we have heard in 
testimony in other committees, is overkill in many instances, 
and putting more pills out into the potential illegal market.
    So in those two areas, pharma's responsibility and the 
responsibility of physicians, what would you suggest?
    Secretary Burwell. So in regard to pharma, I think two of 
the most important things that pharma can do right now is 
develop true abuse-deterrent products for existing opioids. The 
other thing is that they need to develop products for pain that 
are not addictive, in terms of the research and the work that 
they need to do in these spaces, at the same time making sure 
that in all of their work that they are making clear the 
dangers of addiction.
    That brings us really to the bridge to the second issue, 
which is the prescribing, and how the prescribing goes.
    Ms. Capito mentioned bills and approaches to limiting that. 
I think we believe right now one of the most important things 
we can do is put out new prescribing guidelines and then make 
sure people are trained in them.
    I am sure you all have the same conversations I have with 
physicians. When you talk to a physician and you say, how much 
time did you spend in training on pain, and usually the answer 
is a very small number of hours, if at all. So making sure that 
we make the advances in terms of that.
    At the same time at NIH, we need to continue our research 
both on the opioid and the treatment of pain side and what work 
we can do there.
    So prescribing, though, is an essential key, as you 
reflected. That large number pills, they are going out time and 
time again. We want to make sure that we are doing everything 
we can to do that.
    The NGA (National Governors Association) just put out a 
number of proposals that we think align with our three-part 
strategy, and we are going to continue working with them as 
well.
    Senator Durbin. Some States are monitoring this, and others 
are not. Shouldn't we have a national standard, if we are 
dealing with a national crisis here? Why would we have 
reporting in some States, so we can monitor abuses, and in 
other States not have it?
    Secretary Burwell. So prescription drug monitoring programs 
exist in all States but one in the union. They are, as you are 
reflecting, at varying levels of quality. And the other thing 
that is a problem with them is their ability to talk to each 
other.
    I did speak with the Governors at the recent NGA about 
getting regional compacts, so we can get some alignment. I have 
2 years running have brought together representatives from each 
of the Governors, all 50 States, so that we start sharing best 
practices, so we can start to raise the level of these 
prescription drug monitoring programs, because that is the 
other thing if you talk to physicians. They say it is hard to 
use--different technologies, number of clicks, those kinds of 
things.
    So working to get best practices and working to get them to 
communicate across State lines, and I think in the Northeast, 
we will get a regional compact.
    Senator Durbin. Thank you.
    Senator Blunt. Thank you, Senator Durbin.
    Senator Moran.
    Senator Moran. Mr. Chairman, thank you very much.
    Secretary, thank you for joining us. Thank you for your 
phone call inquiring about anything we were interested in 
visiting with you about.
    I am always interested in a number of issues that face 
rural hospitals, community pharmacists. I would again express 
my gratitude for the times that CMS, in particular, but your 
department, has worked with us to try to solve individual 
issues that create what appears to be insurmountable problems 
for a community attempting to deliver healthcare to patients in 
the region. I just would thank you for the past cooperation and 
ask if you would continue that and encourage the folks who work 
with you to understand the distinction and the difficulties 
that many small town, rural providers face.
    Let me focus for a moment on NIH. I apologize that I was in 
the Commerce Committee, but perhaps you have addressed this.
    But the mandatory issues that your budget raises are 
troublesome to me, particularly in light of what occurred last 
year. Congress is stepping up and increasing the support under 
the leadership of this subcommittee and our full committee. I 
would encourage you to work with us on budget solutions that 
are likely to occur once--you continue to propose, in some 
instances, user fees.
    I chair the subcommittee on the FDA budget. User fees 
there, mandatory spending here, are unlikely to be solutions to 
the budget challenges that you believe your department faces.

                            WELDON AMENDMENT

    Then I want to ask you a specific question related to the 
State of California. This involves the issue of healthcare 
provider coverage for abortion. Religious entities, as you 
would know, have moral objections. They are protected by 
something called the Weldon Amendment.
    You were asked a year ago about this issue and indicated 
that an ongoing investigation was occurring. The allegation is, 
as you know, that California requires its providers to provide 
abortion services. That presumably violates the Weldon 
Amendment that prohibits that requirement.
    Your answer a year ago was that the investigation was 
occurring, and it would be completed expeditiously. It is now a 
year later, and my question is, is it the opinion of the 
department that the order of California is a violation of the 
Weldon Amendment?
    Secretary Burwell. With regard to this issue, I think you 
know when it was raised with me, raised both externally but 
raised by Members of Congress, we opened the investigation with 
the concerns that have been expressed. The investigation is 
still open, so my ability at this point to comment specifically 
on the question you asked, we need to wait for the completion 
and the finalized investigation for me to comment on the 
specifics of what the outcome of that investigation is.
    So we are not there yet. When we are, we will make sure we 
communicate.
    Senator Moran. That investigation has been ongoing for how 
long?
    Secretary Burwell. The investigation has been ongoing for 
well over a year.
    Senator Moran. Do you have any opinion as to when that will 
be concluded?
    Secretary Burwell. My hope is that it will be soon. I wish 
I could give you a timetable, but I do not want to do that 
because it is an open investigation.
    Senator Moran. I will let my question stand for my concern, 
criticism. I am worried that this is an issue, as you know, 
that has differences of opinion about the outcome. But in my 
view, the law is clear and California is violating the law. It 
is the administration's responsibility to enforce the law. And 
I worry that there may be a plan afoot in which this just 
continues to the end of your term and the end of the 
administration, as compared to fulfilling your 
responsibilities.
    Secretary Burwell. I hear your concerns, Senator.
    Senator Moran. Thank you, Secretary.
    Thank you, Mr. Chairman.
    Senator Blunt. Thank you, Senator Moran.
    Senator Schatz.
    Senator Schatz. Thank you, Mr. Chairman.
    Secretary Burwell, thank you for being here.

                               TELEHEALTH

    The last we spoke, we were talking about telehealth, and we 
were talking about the sort of two tracks to move on. Since 
then, we have had some pretty good legislative collaboration. 
Senators Wicker, Cochran, Cardin, Thune, Warner, and myself, as 
well as a bipartisan group on the House side, introduced the 
CONNECT for Health Act, which attempts to amend 1834(m) in such 
a way that does not cost any money to the Treasury but also 
improves outcomes and reduces cost.
    My question for you is, we also talked about what you 
thought you could do within the existing statutory authorities 
to expand the use of telehealth. I wonder if you have an update 
for me?
    Secretary Burwell. We have expanded the number of 
categories, that we will pay for in that space, so I think that 
is one of the advances that we have made. We are also using 
telehealth in situations right now with the tribes. Right now, 
tribal suicide in the Great Plains is a very serious issue. Our 
ability to get providers there for those children--it is child 
suicide. So we are also working there in new ways to do that.
    In addition to the administrative actions, though, there 
are two important statutory actions that are part of this 
budget that I think are important to highlight because we would 
like to get these authorities. One is, in this budget, you will 
see money for HRSA, and this gets to the rural issues that we 
are focused on. HRSA, some of our federally qualified clinics, 
can actually be the sites to do the telemedicine, so we can get 
that access in rural America. There is money for that in this 
budget.
    The second area is in Medicare Advantage and helping us 
make some changes statutorily so we can use Medicare Advantage 
funding to pay for telehealth, because one of the prohibitions 
to the growth of telehealth is the ability for it to be paid 
for, so the question of whether providers will provide it or 
not.
    So we are doing things administratively. There is 
legislative movement. Thank you for your leadership. And we do 
have two very specific things in the budget that we think will 
make a difference.
    Senator Schatz. We will continue to support you on that. 
Some of those provisions are included in our legislation, so 
whichever vehicle ends up succeeding, I think we are on the 
same page.
    Are there additional administrative actions that are on 
deck, or do you think you have pushed your authorities to their 
limits?
    Secretary Burwell. I think we have pushed our authorities, 
although we continue to look and examine where we can continue 
to add, as we have in terms of adding conditions. But I think 
we need a little help in terms of the payment issues.

                           MEDICARE ADVANTAGE

    The other place that we are working on, in terms of 
administratively, I should mention, is as we are working with 
accountable care organizations, coming back to Ms. Capito's 
question, a number of the accountable care organizations are 
using telemedicine as means by which they can serve their 
patients better. So there are ACOs that are doing it.
    Senator Schatz. Yes. Can you talk about the Medicare 
Advantage proposed change? I think it is an important way to 
make sure we can--for Hawaii, it is 40 percent, 50 percent of 
the market. It makes a big difference, and it potentially 
addresses some of the CBO concerns. So can you flesh that out 
for us?
    Secretary Burwell. Just the idea that if we can get to the 
space, as you said. Medicare Advantage continues to grow, and 
the coverage of Medicare Advantage across the country, not just 
in Hawaii, there is deep penetration. So once we can change 
that payer model, in terms of having Medicare Advantage, we 
think we can lead as a government as a payer, and then others 
will follow in terms of if we can set a standard and have that 
access to do that.
    Senator Schatz. Thank you.
    Last week, CMS announced a partnership with Hawaii to help 
navigate how to best leverage Medicaid in the effort to reduce 
homelessness. We are encouraged by this partnership, and we are 
thankful for working with the State of Hawaii.
    We have a terrible problem with homelessness. It is unique 
among the States, because of our geographic isolation and 
because of our cost of living, in particular the cost of 
housing.
    As you know, a lot of these individuals are more likely to 
have complex medical needs. Can you describe how HHS is 
supporting efforts to permanently house medically fragile 
individuals?
    Secretary Burwell. Yes. So in addition to the work we are 
doing directly on homelessness with Hawaii, the broader issue 
that I think gets to issues that each of you probably face in 
your State, in terms of the medically frail and other issues, 
is right now as part of the Center for Medicare and Medicaid 
Innovation--and this is just such an important place where you 
all give us authorities and money--right now, we are actually 
doing a demonstration to understand when people are coming into 
the healthcare system, if you can establish whether there are 
certain other needs that you can connect them to the services, 
that then you can reduce healthcare costs.
    What we know is so many people, the emergency room visits 
have to do with other complications in people's lives. So what 
we have seen in some work in the private sector is, when you 
actually ask the question about if the person is homeless, do 
they need connections, sometimes to behavioral health services 
or other services, that we can actually reduce the cost, 
because they become more adherent to the drugs. Sometimes they 
are not taking the drug because they do not have food. If you 
can get them connected to the right place to get the food, they 
can take the drugs.
    So there are a number of things that we think, as part of 
what you all gave us in those monies, we will have to measure 
and show that there are results financially and that you do not 
reduce quality of care and hopefully you increase it.
    So those are the places we are working on it.
    Senator Schatz. Thank you very much.
    Senator Blunt. Thank you, Senator Schatz.
    Senator Cassidy.
    Senator Cassidy. Hey, Secretary Burwell, how are you?
    Secretary Burwell. Hello.
    Senator Cassidy. It seemed to be a special pleasure when 
you said it would be the last budget that you will present.
    You know, we only have 5 minutes so if at any point I 
interrupt, it is not to be rude. It is just to expedite.
    A week ago, before Energy and Commerce, you were asked, 
regarding the fact that the administration appears to be giving 
$2 billion to the reinsurance program under the ACA (Affordable 
Care Act), which CRS says contradicts a plain reading of the 
law, knowing that you know that, knowing that you know of which 
I speak, just for context, I think it is Section 1341. It is 
the bottom of page 92, but it is 91 through 93, where this is.
    On the Energy and Commerce Committee, they pointed out a 
CRS memo that said that you were given this $2 billion 
``appears to conflict with the statute.'' You said that you had 
not had time to read the CRS report, but they gave it to you. 
That was a week ago.
    So any thoughts now, after having had a chance to review as 
regards to why the administration appears to be conflicting 
with the statute?
    Secretary Burwell. Senator, we believe that we have the 
authorities. As I mentioned in that hearing, we actually 
published for comment and notice the approach that we were 
going to take to use those authorities, and did not have any of 
the concerns raised as part of that public process.
    Senator Cassidy. Just to point that out, I can tell you I 
have seen comments in which it is buried within a huge Federal 
Register, so sometimes it is not seen until actually 
implemented.
    But it says, ``notwithstanding any other provision.'' I 
think maybe that is what CRS focused upon. Let me see if I can 
find it exactly here.
    But nonetheless, it is very explicit. Money remaining 
unexpended should be used to make--notwithstanding the 
preceding sentence, any contribution shall be deposited into 
the general fund of the Treasury.
    So the fact that $2 billion, which explicitly was said to 
be put into the general fund--do you have a legal memorandum, 
which would justify your position as opposed to that assumed by 
CRS?
    Secretary Burwell. With regard to the decision that we 
made, I know that any of our rulemakings and any of this would 
have gone through our Office of General Counsel. With regard to 
the question of a memo, I do not know if it was done in that 
form.
    I would say that we believe we have the authorities. And as 
one looks at this question, it is an issue that I think we are 
all concerned about, which is downward pressure on health care 
costs.
    Senator Cassidy. Now, if I may interrupt, again, we have 
limited time. And that is what you mention on the Energy and 
Commerce Committee.
    There is a certain letter of the law and spirit of the law. 
I think you are arguing now that that we, by the spirit of the 
law, would want to decrease, et cetera. But the letter of the 
law said that, notwithstanding any other provision, the money 
shall be put back into the Treasury.
    If your attorneys have had the chance to review that CRS 
memo, could you share that with us, because if we are a Nation 
of laws, whatever we think about the ACA, if we are a Nation of 
laws, it cannot just be expediency. It has to be what Congress 
passed. I voted against it, but Congress passed it.
    There is a sense right now that it is expediency. It is not 
the letter of the law, not even a kind of plain reading of the 
law, CRS would put it.
    If I may pause and move to something else, and I do not 
mean to be rude, but there is just such limited time.
    Next, I understand there is going to be a demonstration 
project which would decrease--you mentioned earlier value-based 
reimbursement for drugs. And currently, as we know, there is 
the average sales price plus 6 percent. I think the fear in the 
administration is that might be incentivizing the use of more 
expensive medicines.
    I am told there is a demonstration project that will be 
rolled out in which that will be modified, if you will. You 
know far more about this than I, so if you tell me I am wrong, 
I will accept that.
    What I do not know is, will it just be a decreased 
percentage? Will it be ASP-plus 2 or ASP-plus 4? Or will there 
be a different model in which value-based purchasing is going 
to somehow be used to judge what should be the reimbursement or 
the percent reimbursement on a drug being used.
    Secretary Burwell. With regard to the specific of rolling 
out a proposal, I want to be very careful. This is obviously 
market-moving information, so I won't speak to the specific.
    But with regard to the general point, I think there is 
general bipartisan, actually, support for the fact that when 
you pay someone based on X plus 6 percent, that you actually 
are going to encourage the person in terms of their own 
economic well-being to do that. So I can speak to the broader 
issue.
    With regard to the specifics, we will have more to say 
soon.
    Senator Cassidy. Okay. Got you.
    My gosh, rarely do I exhaust my questions before the end of 
my time, but we were so efficient, thank you.
    I yield back.
    Senator Blunt. Thank you, Senator Cassidy.
    And there will be time for a second round here.
    Senator Lankford.
    Senator Lankford. I ask unanimous consent for his 39 
seconds left over.
    Senator Blunt. Denied.
    Senator Lankford. Secretary Burwell, good to get a chance 
to visit with you again. Thanks for the way you always come 
through and answer our questions. I have many questions as 
well.

                         HOSPITAL REIMBURSEMENT

    Hospital Consumer Assessment of Healthcare Providers and 
Systems survey, one of our favorite surveys when you are 
checking out of the hospital to be able to kind of score your 
own hospital, which is part of the ranking. You have mentioned 
multiple times about the opioid issue. I have a concern, 
hospitals have a concern, that they are being graded and 
reimbursed based on how they treat pain in the hospital, and 
that if someone leaves a hospital, which, frankly, by 
definition, when you leave a hospital, you are going to 
experience pain--you don't go there because of the spa 
treatments--that if you leave the hospital with pain or feel 
like the pain is not being taken care of while at the hospital, 
which incentivizes the hospital to overprescribe, that they get 
a bad score and they are not reimbursed as high.
    The simple question is, have you looked at that language 
lately? Have you evaluated the possibility that CMS is 
incentivizing hospitals to overprescribe pain medicine, so they 
get a higher reimbursement because their scores do not go down?
    Secretary Burwell. Yes, we have looked into it. Mr. 
Alexander raised this issue with me, and we have actually done 
a look at it.
    I think what is important to reflect is we are in the 
middle of the look at it. An initial look in terms of the 
analytics, the money is not enough. It is a very, very small 
percentage. Having said that, I believe, and have gone back to 
the team, that even if it is not about the economics, it may be 
about prescriber's belief. And it may be that they behave in 
ways that are not economically driven and, therefore, we need 
to go at this again.
    So yes, we have looked at it.
    Senator Lankford. I would agree on that, and I would tell 
you that hospitals do not tell me that the money is not enough. 
Right now, they are counting every single penny. To them, that 
is a significant issue, and there seems to be an incentive to 
be able to push doctors--I am not saying that hospitals are 
forcing them, but it is one of the questions they are going 
back to make sure everyone--is everyone treating pain, because 
we are going to ask them when they leave? That creates a very 
perverse incentive.

                       RECOVERY AUDIT CONTRACTORS

    Now let me talk about your favorite subject, RAC (Recovery 
Audit Contractors) audits. I cannot imagine anything we would 
want talk about more fun than RAC audits.
    I questioned one of our hospitals of many just about how 
RAC audits are going and what is happening with that. They sent 
me 49 denials that they have. Thirty-nine of the 49 have so far 
been overturned. All of these are related to a signature that 
was not there, or a date or time was not there.
    The question goes back to you, ``Was it medically 
necessary?'' Yes, they were shown to be medically necessary.
    But the RAC audit proposal and what we are trying to 
approach with RAC audits, my understanding was this is going 
after fraud and medical necessity. It seems to be a tremendous 
amount of money. Just this one group is at $650,000 that was 
about signatures and date and time.
    Secretary Burwell. So we have changed our policy since our 
last conversation that I hope in ways that will take care that.
    So an audit, if one of these is overturned, as you just 
indicated those were, people will not be paid. The other thing 
is, if it is over 30 days, they will not be paid.
    So much of the feedback that we have received from folks 
like you and your constituents, we have taken into account and 
now have different policies in place.
    Senator Lankford. Is there a possibility to have a 
financial incentive on the auditors themselves, that if they 
are pulling files that are then overturned, that there is a 
financial penalty on them?
    Secretary Burwell. I think the economics for them in terms 
of spending time on something you will not receive anything for 
is an economic incentive. Is it enough----
    Senator Lankford. Even if there is a small penalty in there 
just to incentivize them to pay attention to it does help, 
because if they scoop up a bunch and only 20 percent get 
pulled, the incentive is to pull up a larger amount, because 
then if only 20 percent are going to actually go all the way 
through, get a larger amount with 20 percent.
    There is a whole series of issues that are here. Dealing 
with the contingency fee structure versus flat fee. Reducing 
the lookback period so not as long. I think it is 5 years now, 
if I remember that correctly. Lowering that a year, 6 months, 
whatever it may be, so there is not this perpetual sense of a 
long lookback on it. Trying to deal with good actors. When a 
provider has consistently shown they have been good at it, not 
pulling as large of a group. Trying to coordinate between the 
RAC audits and ZPICs (Zone Program Integrity Contractors) to 
make sure they are not getting both at the same time that are 
coming at them.
    A lot of issues that are out there that I would love to be 
able to just send you some of these things. I know you are 
working on them.
    The issue about the reimbursement, they are not paid for 
it. I understand that. That was taken care of a long time ago.
    But there is still more to go. We are still creating a 
hostile environment.
    Secretary Burwell. So we welcome your suggestions and 
thoughts, and I think one of the things we all want to do, 
though, is make sure that we are eliminating fraud in the 
Medicare system.
    Senator Lankford. I would totally agree. That was the 
intent at the beginning. Not giving the date, time, and a 
signature in the right spot on the right sheet is not taking 
care of fraud. That was medically necessary, but we are now 
holding large files for it.

                            WELDON AMENDMENT

    One last thing I want to get a chance to get to is going 
back to something that Senator Moran had mentioned before on 
California and the Weldon Amendment issues. Have you gone to 
the Office of General Counsel to ask a legal opinion about 
California and the Weldon Amendment? Has that been done?
    Secretary Burwell. The Office of General Counsel will be 
involved. The Office of Civil Rights does the investigation.
    Senator Lankford. Correct. Has that formal request already 
been made of them to give a legal opinion to you on it?
    Secretary Burwell. With regard to the question, the General 
Counsel's Office is a part of any of the conversations with 
OCR. I am not sure when you say ``formal request.''
    Senator Lankford. Just to be able to make sure--this is a 
legal question that is out there that seems pretty cut and dry.
    Yes, it is clear California is violating the law. I cannot 
seem to find any wiggle room. And 18 months later, we are still 
getting, ``We are still investigating.'' We want to find out 
how thorough is this investigation after 18 months and a clear 
violation of law.
    Secretary Burwell. The General Counsel is deeply involved.
    Senator Lankford. So can we get a copy of some of those 
reports that are coming in, so we can track what is happening?
    Secretary Burwell. We are in the middle of an 
investigation, and when the investigation closes, we will 
communicate----
    Senator Lankford. Which you would expect by when?
    Secretary Burwell. As I said to Senator Moran, at this 
point, I do not have a timetable, but I do expect us to come to 
closure.
    Senator Lankford. Eighteen months is a long time to look at 
something.
    Secretary Burwell. I appreciate that.
    Senator Lankford. So it is still unknown. It could be 
another 18 months.
    Secretary Burwell. I do not think it will be another 18 
months, because I will not be here.
    Senator Lankford. So it ends at the point?
    Secretary Burwell. I do not want to commit to a time table, 
but I think your question is, is this an issue that will become 
resolved, I think it is your question.
    Senator Lankford. Yes.
    Secretary Burwell. And I look forward to doing that.
    Senator Lankford. In your time.
    Thank you. I yield back.
    Senator Blunt. We will start our second round with Senator 
Murray.

                                NALOXONE

    Senator Murray. Thank you again, Madam Secretary.
    We have talked a lot about opioids. You spoke about the 
need to increase medication-assisted treatment to solve the 
opioid crisis, the importance of naloxone.
    Could you talk a little bit about how your budget increases 
access to that lifesaving drug?
    Secretary Burwell. With regard to naloxone or what some 
refer to as Narcan, we are using some of the monies that we 
have available right now. But a portion of the money, of the 
$1.1 billion that we have asked for, would be for those.
    What we would want to do is get that money to communities 
so that first responders can get those treatments and get that 
out. Some of the money would need to be used for training, so 
we make sure people know how to use it. But we want to get the 
money out.
    In addition, we are complementing those efforts. The FDA 
just approved recently the most recent nasal naloxone or 
Narcan, which will mean that others can be able to give it out 
in terms of people who are trained in terms of injections. So 
we are working on that side of it as well.
    Senator Murray. That is part of your budget?
    Secretary Burwell. It is. The FDA, has already approved it 
and is moving forward. But we want to make sure that the monies 
will go toward whatever types of access people want, whether it 
is injection or nasal.

                         ANTIBIOTIC RESISTANCE

    Senator Murray. Okay.
    As I said in my opening statement, I am concerned about 
many pressing needs facing the subcommittee, but one area I did 
not talk about that really worries me is combating antibiotic 
resistance.
    As you know, we face the prospect of living in a world 
where antibiotics are no longer effective. Your request 
includes an additional $40 million at CDC for the second year 
of an initiative to address antibiotic resistance, which brings 
the total to I believe to $200 million. I applaud that 
increase. It is significantly less than you requested last 
year, which was $264 million, and you are not requesting an 
increase at NIH or BARDA for addressing antibiotic resistance.
    So I wanted to ask you, where do we stand in our fight 
against antibiotic resistance? And are NIH and BARDA developing 
promising new drugs in the pipeline? Is there more to come?
    Secretary Burwell. Yes. In terms of where the money is 
focused, NIH is focused on making sure that we are developing 
the antibiotics that are not resistant. At the same time, 
diagnostics are also a very important part of this, in terms of 
our ability for people to go and be tested and, no, you do not 
need an antibiotic. Many people demand it because they think 
that is what they need, and our diagnostics are not fast and 
quick enough. So that is part of the research.
    BARDA is deeply involved as the drugs and things are coming 
through, and the research gets to the place where we can work 
with the private sector to move those along. That is the part 
that BARDA is playing.
    I think with regard to our effort, it is both research and 
there is the other part of the effort, which has to do with 
animals and the question of prescribing in animals. Through FDA 
rulemaking, we are working to get to a place where people only 
prescribe actually for conditions in animals where there is 
something wrong with them versus using these kinds of 
antibiotics for growth and other issues.
    Also making sure that when they are going to be used in 
animals, that they are going to be used with a veterinarian, in 
terms of prescribing and making sure that it is being used in 
an appropriate form.
    Senator Murray. So it is not blanket.
    Secretary Burwell. That is right. So working on all of 
those fronts.
    The other place that I think that is very important--I am 
glad you raised the issue. I just had the Global Health 
Security Initiative group of countries that President Bush 
started after 9/11. This is a group that met in October 2011 to 
address--and it is our partners like Japan, Mexico, the G-7. 
They are many of the partners.
    This is an issue that we talked about specifically. There 
is a lot of energy on antibiotic resistance, and I think we may 
even hear conversations about it at this year's United Nations 
General Assembly.
    Senator Murray. Because it is an international discussion.
    Secretary Burwell. Yes. So we have our plan. We have a 
strategy as the United States, but we are also working around 
the world and in partnership with others. The British have a 
leadership role. The Germans have a leadership role here, too.
    Senator Murray. Good. I really appreciate that. In talking 
to doctors at the Children's Hospital in Seattle and hearing 
that kids are born today resistant, and there is nothing they 
can do when they are 4 or 5 days old. This is an increasing 
problem.

                             WOMEN'S HEALTH

    Finally, I wanted to ask you, for a lot of women, the 
Affordable Care Act expanded coverage of all FDA-approved 
contraceptives has reduced their out-of-pocket costs and given 
them access to more effective methods. In fact, we know that 
women have saved nearly $500 million because of this provision.
    But unfortunately, we are still hearing from women 
experiencing difficulty in getting guaranteed no-cost coverage 
from their plans. I understand some insurance carriers are not 
adhering to the requirements. I wanted to ask you if you knew 
which carriers are requiring cost-sharing, are declining 
coverage, or are otherwise limiting coverage for 
contraceptives?
    Secretary Burwell. Since we last spoke, we put out 
additional guidance to the insurers to make sure they know. If 
there are cases that you are hearing from your constituents, if 
you can let us know, because then it becomes an enforcement 
matter.
    Senator Murray. Okay. That is really important, and we will 
do that. I hope you will follow up on that.
    Secretary Burwell. Yes.
    Senator Murray. Great.
    Senator Blunt. Thank you, Senator Murray.
    Just as an aside, this is not really a question, but on the 
mandatory funding issue, which I have great confidence that 
Senator Alexander and Senator Murray and their committee are 
going to look at in a way that does not slow us down with 
discretionary funding, I will say the history of mandatory 
funding would discourage you on that front.
    Congress added mandatory funding for community health 
centers. There has been no increase in that discretionary 
account since that happened.
    We had mandatory funding for the National Health Service 
Corporation. There has been no discretionary funding at all for 
that, since it went mandatory. I noticed in your budget this 
year you are asking for discretionary funding again for the 
National Health Service Corps.
    It probably does not have to be that way, but I will tell 
you it has been that way. Whenever there is a mandatory 
component that steps in, the history has been that the whole 
focus is on maintaining the mandatory component, not on what 
used to be the discretionary funding. And I would hope that 
would not happen again.

                            PAIN MANAGEMENT

    Senator Murray had a question about antibiotics that led me 
to another thought on pain I meant to make. Is there any 
advance being made in trying to find less addictive pain 
alternatives? What can we do to encourage that?
    Secretary Burwell. It can happen in a number of different 
ways.
    One is the pharmacy question and making sure that 
pharmaceutical companies are developing drugs that actually are 
not addictive that can be treatments for pain.
    Another place where we can make probably some advances is 
actually in how anesthesia is done, because if anesthesia is 
done in a way that a person does not have acute pain in the 
first 24 to 48 hours after surgery--and it can depend on 
anesthesia that was used to put you under.
    I recently had a conversation with medical providers about 
that issue. The Governors, actually, are the ones who brought 
up that issue.
    But I think the other place where we are as a government 
working on it is actually the Veterans Administration. The 
V.A., as I am sure you know, has a lot of patients with a lot 
of pain. And one of the things that Secretary McDonald is 
focusing on are alternative approaches to pain, whether it is 
approaches like acupuncture or other issues that people can use 
as alternative approaches to pills for pain.
    So working across that whole suite of how we can treat pain 
at the same time we reduce the prescribing, I think we need to 
do both of those steps at once.

                               RAC AUDITS

    Senator Blunt. I hope we can find solutions there and in 
other places.
    On the RAC audit topic, I appreciate what you have had to 
say about that. I think clerical errors are not what we should 
be headed for here. We obviously should discourage needless 
clerical errors, but that should not become a reason to hold 
somebody's money for multiple months at a time.
    Last year, we provided a $20 million increase. It was a 
little less than you asked for, but this year you have asked 
for $90 million more. What do you think $90 million gets you 
beyond where we are today?
    Secretary Burwell. I think it gets us a major reduction in 
the numbers. As I said, we want to work across a three-part 
strategy. Our success is going to be dependent on the funding 
of the administrative law judges, as well as some of the 
statutory changes. If you get both of those together, I think 
we can reduce this backlog much more quickly. So the 
interaction of how much the money will help, but at a minimum, 
we know we are increasing the productivity of our 
administrative law judges by having the administrative changes 
we are doing. We are increasing what is going to come in and 
what we can process. Some of that has to do with settlements 
and moving things through more quickly.
    We have asked for the money that we think can put us on a 
path to get that backlog down. I think you know, right now, it 
is hundreds of thousands.
    Senator Blunt. And what are you gaining by now looking at 
clerical errors different than fraud, in terms of the backlog.
    Secretary Burwell. I will have to go and check on the 
specific issue of things like signature and how they go through 
the system. I apologize, I do not know the answer.
    Senator Blunt. Whatever you do there I think will be very 
well-received by all of the people who are impacted, including 
the committee, because we are constantly hearing from the 
healthcare providers that we represent that they are winning 
case after case after case, but the money is held for a long 
time. By the time they get it, other problems have been created 
because of the fact they did not have the reimbursement that 
they were qualified for.
    It sounds like to me, hopefully, we are headed in a much 
better direction there.
    I have a couple other questions, but Senator Cochran.
    Senator Cochran. Mr. Chairman, there is some concern about 
whether or not the Appropriations Committee's prerogatives are 
being supported not by the administration in its totality. But 
a review suggests that they are requesting funding through 
legislation under the jurisdiction of the legislative 
committees instead of through the Appropriations Committee.
    Is this accurate or is my staff confused?
    Secretary Burwell. Are they referring to the mandatory 
requests?
    Senator Cochran. Yes.
    Secretary Burwell. I think this is a question, and we have 
seen it. Mr. Blunt just gave the examples of where these issues 
have crossed over. I think your point, Mr. Blunt, was not 
successfully for the long term, I think.
    But we have seen it occur on either side. I think this 
comes to the question of where we want to be as a Nation with 
regard to our levels of discretionary spending. And I think the 
important issue that we try to meet in terms of the standard 
that we know people care about is making sure things are paid 
for, in terms of as we put the stuff on mandatory, we did not 
just add to the deficit. We put in mechanisms overall that we 
believe are paying for it.
    The question of how we get there with the partial buyback 
of sequester in already what were probably, some might say, 
tighter levels before the sequester and how we do it, I think 
it can be done in any number of ways. I think we are trying to 
do it in a way that is paid for, but also sticks with the 
sequester and the caps that are given.
    How it works and whether or not the caps can go up, we 
could move to a different place and pay for that again, as we 
have starting with Ryan-Murray a number years ago, I think we 
are open to the conversation. We try to provide monies so that 
it can be covered. I think that is one of the most important 
things, whether it is on the mandatory or discretionary side, 
how it impacts the deficit.
    Senator Cochran. Thank you.
    Senator Blunt. Senator Alexander.
    Senator Alexander. Thanks, Mr. Chairman.
    I want to go back just for a moment to the question of 
discretionary and mandatory funding again, particularly while 
these three Senators are here and I am here and you are here.

                     NATIONAL INSTITUTES OF HEALTH

    I agree with Senator Blunt. There is a real risk in 
depending on mandatory funding for the increase we want to see 
in a bipartisan way for the National Institutes of Health. Some 
will want to see more and some will think we can afford less, 
but there is an unusual consensus right now that we want to 
take advantage of this period of time, this exciting period of 
time in science that has the opportunity to help so many 
people. And for my part, I am not interested in seeing 
mandatory funding replace discretionary funding. I would like 
to see us have a goal.
    We did this in the Energy and Water bill to deepen our 
harbors. We saw that as a national imperative and Congress said 
this is the funding goal that we want over the next several 
years, and we have met it for the last 2, and we are making 
pretty good progress on deepening our harbors before the Panama 
Canal widens.
    Now this is a different and I would think more urgent 
issue. So I would like to not think about mandatory funding as 
a replacement for what we should be doing with discretionary 
funding. I think we should build on the 5 percent increase of 
this past year's discretionary funding and continue to move 
upward and forward, if we possibly can.
    That is hard to do, but that is our job to set priorities. 
So I think about mandatory funding, and I am being a little 
repetitive here, as in addition to that. When I think about it 
that way, I want to make it hard for people to think of 
mandatory funding as a substitute.
    So one way, and several of us have talked about this, is to 
have this innovation fund to take several areas where Dr. 
Collins, you, the President have said these are urgent areas, 
and they have a timeline and they have a beginning and an end.
    So for example, we might add to the Precision Medicine 
launch X billion dollars for X years. When that was over, it 
would be gone. You could not say that is going to replace 
discretionary funding.
    The same with 650 more young investigators for a period of 
time. Congress could replace that, but wouldn't have to. The 
Big BioThink Award, Dr. Collins has talked about that, giving 
each of the institutes an amount of money for the biggest idea 
in their field to see what that turns up.
    The Cancer Moonshot, we have yet to hear exactly what that 
is, but we look forward to that.
    Or let's take the BRAIN Initiative, Senator Cassidy even 
suggested this the other day, and I thought it was interesting. 
He said perhaps one way to think about it is as a surge of 
funding. The mandatory funding would be a surge on top of the 
discretionary funding.
    So we would have the discretionary going up every year. 
That would be our goal. But we can move there more rapidly if 
we had a mandatory surge going on for the first 4 or 5 years, 
and then they come together and we would be closer. I thought 
that was pretty interesting.
    So that is the way I am thinking about it, and I just 
wanted to say those things while we are all here.
    Secretary Burwell. Building on that thought and that 
approach, as you think about medication-assisted treatment and 
getting that initial capacity, the idea that what you need to 
do because behavioral health and many of these issues are taken 
care of at the State and local, and what we do is actually 
jumpstart the State and local communities' ability to get to a 
place where they have the capacity and then they take it on.
    So to build on your idea, I think there are approaches that 
we can think through that might work in terms of your approach 
to thinking of it as additive, but not replacing.
    Senator Alexander. If I may interrupt, if you did it that 
way, let's say we had a 5-year surge to help launch Precision 
Medicine, we would not have to spend the same amount every 
year. In fact, that may be a waste of money. We might spend 
some this year, some next year, the most the third year, less 
the fourth year, and back down the fifth year. That might be 
the most effective use of money.
    That can be done with mandatory. That can be done with 
mandatory funding.
    So then I just want to reiterate the obvious. There is a 
lot in the legislation that Senator Murray and I are working on 
in support of Precision Medicine in addition to the money. The 
electronic healthcare records that you have given a lot of 
attention to, giving NIH researchers the authority to share 
their data, more flexibility so you can have more arrangements 
like the Google Vanderbilt arrangement that you announced the 
other day, strengthen privacy protections.
    That plus the electronic medical records are absolutely 
essential to the Precision Medicine Initiative, as well as the 
money.
    I just want to reiterate, none of that is likely to happen 
unless it is part of this bill we are doing.
    So we have to get a result. We have to come to some 
consensus. And I hope we do it by about mid-April.
    Senator Blunt. Well, Secretary Burwell, on the research 
component and, in fact, on many of the things we are talking 
about, I think there is a commonality of goals here, shared 
goals, that hopefully we can figure out how to take advantage 
of. Our increase in NIH research was actually 6.6 percent. That 
is 5 percent plus inflation.
    That is a goal that Senator Durbin said that if we just had 
that as our goal from now on, that would do a lot for families 
that would do a lot for taxpayers.
    A statistic that gets anybody's attention when I use it is 
our projection that, on Alzheimer's alone, we are spending a 
quarter of $1 trillion annually right now. We will be spending 
$1.1 trillion of today's dollars by 2050, which is more than 
twice the defense budget. Most people, including me, when you 
say $1.1 trillion, that does not trigger a whole lot in my mind 
that is more scary than some lower number than that. When you 
say twice the defense budget, obviously, whatever we learn from 
what will be relatively small investment in research is 
important.
    But if you are going to have a pattern, the second year of 
a pattern is really important. So we did $2 billion, added $2 
billion to the $30 billion last year. This would be a terrible 
year to wind up cutting that by $800 million. This would be a 
great year to add another 5 percent plus inflation, in addition 
to whatever else we can do for short-term ways to move us 
forward there.

                             MENTAL HEALTH

    My last question is going to be on just mental health. I do 
appreciate your stepping forward and looking at Excellence in 
Mental Health.
    Again, I will do just exactly what Senator Alexander did, 
while I have Senator Alexander and Senator Murray here, I would 
say when we were able to pass the demonstration projects on 
Excellence in Mental Health, which has been very well-received 
by the mental health community, the goal that Senator Stabenow 
and I had when we introduced that legislation was that the 
initial problem to be solved is having somewhere to go.
    Having providers is really important. Various different 
ways to handle privacy issues that might relate to your support 
group is important. But if you do not have anywhere to go, none 
of those things really matter.
    I know you are looking at a way we can move from 8 to 14 
States. We are talking to CBO about some numbers that might let 
us move further than that, because I think, and this is the 
question for you, I think what is generally believed to be the 
case, and what initial studies have indicated, is that really 
is it not only the right thing to do, but it really does not 
cost anything in total healthcare dollars to treat behavioral 
health like all other health because it is so much easier to 
deal with every other problem that someone has that has a 
behavioral health problem. And I will let you comment on that.
    Secretary Burwell. Yes, I think it gets to the part of the 
conversation that we had with the Senator from Hawaii in terms 
of the importance of how these issues interact with our overall 
healthcare cost whether it is behavioral health issues or also 
the issues of homelessness, other kinds of things that inhibit 
people from getting to the health they do.
    I think you know we had put the money in to build on the 
project that you and Senator Stabenow and Ms. Matsui on the 
House side have been very engaged in. I think you know we have 
worked with you to implement it faster than the statutory 
deadline in terms of getting everything out, because we want to 
shift very quickly to what you said. Where there is equity in 
terms of behavioral health issues and places for people to go 
to do it, we think we can do that in ways, as I think you 
indicated, that can move us to a place where we have delivery 
system reform, too, the way you have done it in terms of 
quality measures, access for people, and getting to a base 
where you get better quality at a more affordable price.
    Senator Blunt. I think the way we have required the law 
enforcement community and emergency rooms to become the go-to 
place for behavioral health is outrageous.
    Secretary Burwell. It is.
    Senator Blunt. Just outrageous.
    Also, on the opioid problem, and Senator Shaheen, we are 
coming right to her, and this is an issue that she has been 
very engaged in, in telehealth, I have an amendment that I 
believe will be accepted on that bill that would allow 
telehealth to also be part of the mix of things coming together 
for dealing with opioids.
    Senator Shaheen.
    Senator Shaheen. Thank you, Mr. Chairman.
    Thank you very much, Secretary Burwell, for being here 
today.
    Just to pick up on the comments about behavioral health, as 
you both know, and the committee knows I am sure, that is a 
critical piece of addressing the substance abuse problem that 
we have in the country. We are not talking about just treating 
overdoses and heroin and opioid abuse, but often there is a 
mental health issue that accompanies that. So we have to start 
looking at this as an integrated system that treats the whole 
person.

                          DRUG ABUSE EPIDEMIC

    I very much appreciate what you have put in and the 
administration has put in to address the heroin and opioid--I 
call it a pandemic, because that is what it really is. We are 
losing 47,000 people a year. In New Hampshire, we are losing 
more than a person a day due to drug overdoses.
    The chairman talked about the emergency supplemental 
funding that we tried to pass yesterday as we were trying to 
get the Comprehensive Addiction and Recovery Act through. I was 
disappointed that that did not pass, because as I have traveled 
around, what I hear, whether it is the treatment providers or 
whether it is families who have lost someone or are trying to 
get someone into treatment or law enforcement professionals, 
the issue is the same. And that is that they are looking for 
funding because they do not have the resources they need.
    Just to give one example, I do not know if you have talked 
about this, but we have chronically underfunded the accounts 
within Health and Human Services that allow us to provide 
treatment and prevention. In fiscal year 2017, it would take 
$483 million just to bring SAMHSA prevention and treatment 
block grants back to the levels in 2006.
    With that as a little background, can you talk about how 
your budget will address the drug abuse epidemic and how you 
are coordinating with other agencies within the Federal 
Government to address this huge problem that so much of the 
country is facing?
    Secretary Burwell. Thank you for your leadership, 
especially in the area of the funding issue, which I think you 
know we think is critical and have discussed, because it is 
what you just said, Mr. Blunt, in terms of, if people cannot 
get access to the care, and if that is not available, and that 
is the issue. As I said, I have talked to the sheriffs who say, 
``I do not want to be a healthcare provider, and I do not want 
to be a social worker, but I see this person again and again 
and again. I have young men who are trained to do the law 
enforcement, but not trained to help a person get off of their 
addiction. We apply the Narcan, but then I am going to see them 
again.''
    So having that access and that is what the vast bulk of 
that money goes toward, in terms of the medication-assisted 
treatment. We need to build the capacity.
    It is related to our behavioral health issues, that we do 
not have the capacity that we need across the country. That is 
why I am happy and open to thinking about, is it a one-time 
shot to get the capacity?
    But as you reflected, the budgets of SAMHSA and other parts 
of our organization that deal with these issues have not grown 
with inflation over the past years.
    That is why I think it is a critical moment for the 
increases that we need to see. I think more than anything, it 
is about the problem and the magnitude of the problem, because 
I do not know that one should argue that you should just grow. 
I do not believe that, having come from OMB. So I don't believe 
it is just about growth year over year. It is about need. So 
that is where I would focus the issue of the money.
    With regard to our coordination with others, we obviously 
coordinate very closely with the Office of the National Drug 
Coordinator, Mr. Botticelli at the White House, and also with 
our partners. As I mentioned, V.A. is working on the pain 
issue, so I have met with Secretary McDonald, so that they can 
make progress in that space. I spent time with the Attorney 
General.
    The PDM piece that we discussed earlier, the Prescription 
Drug Monitoring programs that I think it was Senator Durbin 
raised. Much of that work is actually done out of Justice. The 
other thing is drug takebacks are done out of Justice.
    The other issues around heroin, we have talked about them 
in conjunction with the opioids and the transition that people 
make, but there is also the heroin coming into our country. 
That is more a Justice Department issue.
    So working coordination, those are the main pieces. But 
also, as you know, Secretary Vilsack has become engaged on the 
rural part of this and is helping us in that space as well as a 
voice, a convener, and getting to one of the other attenuated 
issues, which is economics. USDA's sole focus is on rural 
economic development, so they are a part of that solution as 
well.
    Senator Shaheen. Thank you.
    Mr. Chairman, my time is up. Can I ask one more question?
    Senator Blunt. Go ahead.

                               ZIKA VIRUS

    Senator Shaheen. Okay. Thank you.
    I know that you are also focused on the Zika virus, and 
what we need to do to get in front of that. As you pointed out, 
it is very scary to think of what the potential impact of that 
could be. We just had a woman in New Hampshire who was 
diagnosed as having the Zika virus. Fortunately, she was not 
pregnant, but she had gotten it through sexual transmission 
with her partner who had been in the Caribbean.
    Can you speak to the role of family planning, and the 
accounts that are included in the budget and the role that they 
play in the life of women and families as we look at something 
like a potential Zika outbreak?
    Secretary Burwell. I think one of the things we are very 
focused on is making sure that everyone has the information 
that they need to make the choices and decisions that they need 
to make, and that they have access to the tools that they need 
and want with regard to family planning and contraception.
    Our budget, the supplement, proposes no changes to our 
approaches in terms of making sure that there is access. We 
talked a little bit about that access issue in terms of the 
Affordable Care Act and the idea that you can do this without 
copayments in terms of not being charged. So we are very 
focused on making sure that people have the right information 
to make the right choices for them, especially in the area of 
contraception and protection.
    I think you know we have recommended that there be no 
unprotected sex for pregnant women who have partners who have 
traveled to the region. That is the guidance that we have 
offered from CDC during the entire time of the pregnancy. So as 
we learn more, we will continue to put out updated guidance, as 
soon as we get the research back.
    I am hopeful that in the next bit, we will see more 
research in terms of women and their pregnancies and 
understanding if there is a more acute impact in that first 
trimester, like we have seen with measles and rubella. Does it 
follow that pattern or not? We do not know yet.
    But as we get more information, people can make the choices 
across-the-board with regard to prevention, as well as uses of 
contraception during pregnancy.
    Senator Shaheen. Thank you.
    Thank you, Mr. Chairman.
    Senator Blunt. Senator Murray.
    Senator Murray. Madam Secretary, thank you. I just want to 
clarify one thing, and then conclude. So your recommendation 
from CDC is that even if a man travels in October and his wife 
is pregnant, for 9 months, unprotected sex, coming back from 
traveling to a foreign country?
    Secretary Burwell. We recommend that they are careful 
because right now we cannot determine how long Zika lives in 
semen. We know that Zika lives in blood. Our research to date 
has shown Zika lives in a person's blood system, in terms of 
that, we think it is about a week after you have had finished 
to the disease.
    But remember, for 80 percent of the people, you do not know 
if you have had it or not, because you are not symptomatic.
    With regard to semen, we do not know yet.
    Senator Murray. So it could be much longer.
    Secretary Burwell. We do not know.
    Senator Murray. All right.
    With that, thank you very much. I do have additional 
questions I will submit for the record.
    But thank you very much, Mr. Chairman.

                     ADDITIONAL COMMITTEE QUESTIONS

    Senator Blunt. Well, the record will be open for additional 
questions.
    One question I will ask for the record, but I want to be 
sure it was heard today is, I have heard lots of concerns about 
round three of the competitive bidding for durable medical 
equipment, with some concern that we are rushing through those 
changes too quickly and that they will have a negative impact 
on seniors living in rural Missouri. I will have two or three 
questions on that topic, and several others on other topics. 
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
                         risk corridor program
    Question. The Risk Corridor program was designed to be budget 
neutral over 3 years. In the first year of the program, insurers paid 
$362 million into the Risk Corridor program while submitting $2.87 
billion in payment claims. Had the Labor/HHS bill not continued a 
general provision requiring the program to operate in a budget neutral 
manner, the Federal Government would have lost $2.5 billion. Yet, the 
budget request includes, for a second year, a request to eliminate this 
provision. Why does the Department propose to eliminate this provision 
when HHS has issued guidance stating the program should be implemented 
in a budget neutral manner?
    Answer. As in prior years, the Administration remains opposed to 
including policy riders in appropriations bills because they are an 
unwarranted limitation on Administrative flexibility.
    It is important to note that we have made payments for the first 
program year of the 3-year program. Additional risk corridors payments 
for program year 2014 will be paid out of program year 2015 risk 
corridors collections, and if necessary, program year 2016 collections. 
We will not know the total loss or gain for the program until the fall 
of 2017, when the data from all 3 years of the program can be analyzed 
and verified. As we have said previously, in the event of a shortfall 
at the conclusion of the 3-year risk corridors program, the agency will 
work with Congress to provide necessary funds for outstanding payment.
    Question. If the Risk Corridor account faces a shortage in its 
final year, do you intend to use discretionary dollars to make payments 
to insurers? Is that why you want the prohibition on using 
discretionary funding contained in the Labor/HHS bill removed?
    Answer. It is not possible to know whether or not other sources of 
funding will be necessary. Additional risk corridors payments for the 
2014 program year will be paid out of program year 2015 risk corridors 
collections, and if necessary, program year 2016 collections. As we 
have said previously, in the event of a shortfall at the conclusion of 
the 3-year risk corridors program, the agency will work with Congress 
to provide necessary funds for outstanding payment. We will not know 
the total loss or gain for the program until the fall of 2017, when the 
data from all 3 years of the program can be analyzed and verified.
    Question. Will the Risk Corridor program be budget neutral over 3 
years?
    Answer. Risk corridor payments and charges are based on many 
factors, including how issuers price their premiums compared to the 
costs they incur, as well as any reinsurance and risk adjustment 
payments or charges. Risk corridor collections from subsequent years 
can be used to make payments for prior year shortfalls. We will not 
know the total loss or gain for the program until the fall of 2017, 
when the data from all 3 years of the program can be analyzed and 
verified.
                           project bioshield
    Question. Madam Secretary, in fiscal year 2016, the Subcommittee 
provided $510 million for Project Bioshield, $136 million below the 
President's request. For fiscal year 2017, you requested $350 million, 
$160 million below fiscal year 2016. Why was there such a dramatic 
funding reduction to this key national preparedness program?
    What priorities changed?
    Specifically, what happened to the 12 medical countermeasures that 
were waiting to be purchased for Project Bioshield?
    How will this reduction in funding impact our national 
preparedness? Will the Department be able to purchase enough medical 
countermeasures to protect the public?
    Answer. Thank you for your ongoing leadership on this critical 
national security issue. Project BioShield is a shared national defense 
priority. The fiscal year 2017 President's Budget will enable us to 
make meaningful progress on vital medical countermeasure procurements. 
Unlike a grant or research program that supports a steady and recurring 
level of effort, the Project BioShield budget is made up of a different 
set of discrete procurements in any given year when medical 
countermeasures are mature enough in development to meet FDA 
requirements for accessibility under Emergency Use Authorization.
    In addition to the fiscal year 2017 Budget request of $350 million, 
the Department has obligated nearly $50 million already for the 
purchase of anthrax antibodies out of the $510 million from the fiscal 
year 2016 appropriation and has plans to obligate the remaining balance 
on new medical countermeasures (new anthrax vaccine, lyophilized 
smallpox vaccine, and radiation-related point-of-care biodosimetry 
devices) in the coming months. In fiscal year 2017 the new resources 
will enable the Department to procure small quantities of a few 
additional chemical, biological, radiological and nuclear medical 
countermeasures sufficiently mature for procurement, including:
  --New Ebola vaccines and immunotherapeutics for the prevention and 
        treatment of Ebola infections.
  --New high throughput biodosimetry devices to measure internal 
        radiation exposure following a detonation.
  --New antibiotics for the treatment of bacterial biothreats and high 
        priority antimicrobial resistant bacteria.
  --New diagnostics for the detection of anthrax in exposed persons.
  --Replenishment of anti-neutropenia cytokines for the treatment of 
        radiation-induced blood illnesses.
    In fiscal year 2014-2015, BARDA purchased five new medical 
countermeasures under Project BioShield and anticipates purchasing 
three new medical countermeasures in fiscal year 2016. Through its 
advanced research and development program, BARDA has built a robust 
portfolio of candidate products.
    Additional candidates have the potential to transition to 
procurement under Project BioShield in the future.
    BARDA and the Public Health Emergency Medical Countermeasures 
Enterprise (PHEMCE) are committed to maintaining our national 
preparedness and making sure that medical countermeasures are available 
when needed. Maintaining stockpiles of medical countermeasures 
typically entails large procurement costs and is associated with 
substantial carrying costs. In an era of constrained resources, BARDA 
and its PHEMCE partners are mindful of the need to meet established 
requirements, sustain preparedness, and be good stewards of the 
taxpayers' investments. To this end, the PHEMCE is currently working to 
refresh the material threat assessments that form the foundation for 
our requirements, many of which have not been reassessed in years. 
BARDA, for its part, emphasizes innovative approaches to total 
lifecycle cost-containment and strives to decrease the long-term costs 
of stockpiling medical countermeasures.
  --One method is repurposing of commercial products and taking 
        advantage of their commercial market, under vendor managed 
        inventory (VMI). This method is currently being leveraged for 
        cytokines to address neutropenia resulting from exposure to 
        ionizing radiation.
  --Another method that BARDA is employing is stockpiling of bulk 
        intermediates. Bulk products do not have expiry associated with 
        them like final drug products and can be maintained for longer 
        periods of time. Stockpiling of bulk intermediates also allows 
        BARDA to cut manufacturing times if additional product is 
        necessary for a larger event.
          recovery audit contractors/medicare appeals process
    Question. Madam Secretary, your budget provides significant support 
for several levels of the Medicare Appeals Process but what are you 
doing to address the root of the problem: the Recovery Audit 
Contractors (RACs) who serve as the gatekeepers to the process? What is 
the status of the RAC contracts that include the new requirements to 
address these problems?
    Answer. Recovery Auditors are important partners as we work to 
identify and correct Medicare improper payments. In 2014, in response 
to stakeholder and industry feedback, CMS took several steps to improve 
the Recovery Audit Program to increase transparency and reduce provider 
burden. For example:
  --Hospitals should not be the only provider type subject to review by 
        Recovery Auditors. Recently announced additional documentation 
        request (ADR) limits will require diversification of ADRs 
        across all facility claims in proportion to the provider's 
        types of bills and will be based on provider risk, being 
        adjusted up or down based on a provider's denial rate.
  --CMS established a requirement that Recovery Auditors must complete 
        complex reviews within 30 days, and failure to do so will 
        result in the loss of the Recovery Auditor's contingency fee, 
        even if an error is found.
  --CMS has required Recovery Auditors to wait 30 days before sending a 
        claim to the MAC for adjustment. This 30-day period allows the 
        provider to submit a discussion period request before the MAC 
        makes any payment adjustment.
  --Recovery Auditors will not receive a contingency fee until after 
        the second level of appeal is exhausted. This delay in payment 
        helps assure providers that the decision made by the Recovery 
        Auditor was correct based on Medicare's statutes, coverage 
        determinations, regulations, and manuals.
    In addition, CMS is implementing a risk-based approach that will 
allow Recovery Auditors to focus their reviews on providers who 
demonstrate a high denial rate or have not changed their billing 
patterns despite additional education, while focusing less on providers 
following Medicare's rules. These and other program improvements to 
reduce provider burden, enhance oversight and review accuracy, and 
increase program transparency can be found here: https://www.cms.gov/
Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-
Compliance-Programs/Recovery-Audit-Program/Downloads/Recovery-Audit-
Program-Enhancements11-6-15-Update-.pdf.
    As of November 16, 2015, all current Recovery Auditors signed 
contract modifications that implemented enhancements to the Recovery 
Audit program. The current Recovery Auditors will continue recovery 
auditing activities at least through July 31, 2016 while CMS continues 
the procurement process for new Recovery Audit Program contracts, which 
will implement the remaining program enhancements.
    Although the growth of Recovery Auditor appeals has contributed to 
the Medicare Appeals backlog, the other types of workload are also 
contributing to growth in appeals, and subsequently the backlog, in 
significant ways. The increase in the backlog has resulted from growth 
in each of the three workloads that HHS measures--Recovery Auditor, 
traditional workload (Medicare Part A and B; Durable Medical 
Equipment), and dual eligible workload, also known as the Medicaid 
State Agency workload. Further, with administrative actions undertaken 
by the Department to address the backlog, the current appeals in the 
backlog that were generated by Recovery Audit activities represent only 
a small fraction of the backlog.
    My budget request for OMHA, the Department Appeals Board, and CMS 
is an important component of the comprehensive strategy the Department 
has developed to significantly reduce the backlog of Medicare appeals. 
Taken together, the additional funding, administrative initiatives and 
legislative proposals will help make sure beneficiaries and providers 
have timely resolution of appeals.
       world health organization guidelines for milk consumption
    Question. In January, the World Health Organization (WHO) issued 
draft guidance on milk consumption by young children. The guidance 
proposes the establishment of significant new restrictions and 
prohibitions on the promotion and marketing of milk products for young 
children. It is my understanding that this proposal received little 
public input and that when several Member States requested more time to 
review the proposal, they were given four weeks. What is the Department 
doing to ensure that such examination takes place and that U.S. 
concerns about this proposal are properly taken into account by the 
WHO?
    Answer. At the request of Member States, the World Health 
Organization (WHO) developed draft guidance on ending the inappropriate 
promotion of foods for infants and young children, and presented it to 
the WHO Executive Board for potential endorsement. This draft guidance 
aims to support countries in protecting and promoting optimal nutrition 
for children during the first 3 years of life, a critical window for 
health and nutrition outcomes.
    The WHO developed the draft guidance using a Scientific and 
Technical Advisory Group process. Convened in 2013, the Scientific and 
Technical Advisory Group produced several reports, including a draft of 
the guidance that they presented to WHO in 2015. Following online and 
in-person public consultations, the WHO presented a revised draft 
guidance to Member States at the WHO Executive Board meeting in January 
2016. Following the meeting, the WHO opened an additional consultation 
period in February 2016 to allow time for further Member State comment. 
The guidance is not binding on Member States.
    The WHO draft guidance advises Member States on ending 
inappropriate promotion to consumers of foods for infants and young 
children. The draft does not seek to prohibit the marketing of all milk 
products consumed by young children, to limit product availability, or 
to revise recommendations for optimal infant and child feeding 
practices. The document does recommend that countries prohibit the 
promotion of breast-milk substitutes marketed for feeding children up 
to 3 years of age.
    In February 2016, HHS led a process to solicit input from relevant 
Federal agencies and prepare a technical comment submission to the WHO. 
HHS also met with multiple stakeholders, both individually and with 
other agencies, on the matter. HHS transmitted comments and discussed 
them with the WHO Nutrition Department, conveying that revisions are 
needed to present Member States with clear, evidence-based 
recommendations. The HHS Office of Global Affairs continues to monitor 
the development of the draft guidance and will continue dialogue with 
U.S. agencies and stakeholders in developing a U.S. position on the 
issue for the World Health Assembly this May.
    Question. It is my understanding the Department provided technical 
comments to the WHO on the guidance. Please provide a copy of the 
comments to the Subcommittee.
    Answer. Please see attachment ``U.S. comments on WHO Guidance on 
Ending the Inappropriate Promotion of Foods for Infants and Young 
Children.''
                            weldon amendment
    Question. The Weldon Amendment has been Federal law for over a 
decade. It prohibits any State government receiving funds we 
appropriate to discriminate against a health insurance plan that does 
not cover abortion. Can you tell me how it is possible that 
California's refusal to license such a plan is not discrimination in 
violation of the Weldon Amendment?
    Answer. The Department takes our responsibilities under the Weldon 
Amendment seriously, and HHS supports clear provider conscience clause 
protections. As you know, the Office for Civil Rights currently has 
open investigations related to complaints of Weldon Amendment 
violations. We cannot comment on the status of this particular 
investigation because it is still an open case.
    Question. The Weldon Amendment violations have been pending since 
September 2014. Why is the investigation taking more than a year when, 
fundamentally, this is a legal question? The Weldon Amendment is what 
it is and California has issued its order.
    Answer. I take our responsibilities under the Weldon Amendment 
seriously. We cannot comment on the status of this particular 
investigation because it is still an open case.
    Question. Have you asked the Office of the General Counsel to 
provide an opinion?
    Answer. As expected given the legal issues involved, the Office of 
General Counsel is involved in the issue.
                 strategic national stockpile purchases
    Question. Since 2005, the CDC has stockpiled enough antivirals to 
treat at least 25 percent of the U.S. population. This amount came from 
recommendations outlined in the National Strategy for Pandemic 
Preparedness. The budget requests $77 million for new asset purchases, 
which is on top of the $345.5 million requested for expiring asset 
replacement. Can you provide details on CDC's planned replacement 
purchases, for both new and expiring assets?
    Answer. CDC collaborates with the Public Health Emergency Medical 
Countermeasures Enterprise (PHEMCE) to prioritize and adjust the 
Strategic National Stockpile (SNS) formulary annually based on current 
clinical practice, threats, market availability and available funding. 
CDC also uses PHEMCE recommendations to prepare the SNS Annual Review 
Report that informs HHS budget formulation for influenza antiviral 
drugs and the other medical countermeasures held in the SNS.
    The current PHEMCE recommendations for stockpiling goals represent 
a shift in antiviral drug stockpiling from a shared Federal and State 
responsibility to a solely Federal responsibility. Prior to 2014, the 
goal was for the Federal Government to stockpile 50 million 5-day 
treatment courses of influenza antiviral drugs with the remaining 31 
million courses met through State stockpiling. PHEMCE recognized that 
States were unlikely to continue contributing to stockpiling goals due 
to:
  --Limited funding;
  --Decreases in staffing;
  --Reduced risk perceived by States due to the presence of a Federal 
        stockpile; and
  --Low ranking of influenza antiviral stockpiling as a preparedness 
        priority.
    With the change to sole Federal responsibility, CDC is working 
towards meeting the 80 million course stockpiling goal by increasing 
Federal inventories.
    The following table displays the stockpiling goals for influenza 
antiviral drugs, as well as the SNS on-hand and on-order inventory 
through February 2016.

----------------------------------------------------------------------------------------------------------------
                                                                                         Difference
  Medical countermeasure treatment* in the SNS (courses in        SNS      SNS on-hand    between      On-order
                          millions)                           Stockpiling   inventory   goal and on-  inventory
                                                                goal \1\                    hand
----------------------------------------------------------------------------------------------------------------
Oseltamivir (Tamiflu) 75 mg capsules.......................         38.1         38.0         -0.1            0
Oseltamivir (Tamiflu) 45 mg capsules.......................         4.83          3.2        -1.63            0
Oseltamivir (Tamiflu) 30 mg capsules.......................         16.8         11.8         -5.0            0
Oseltamivir (Tamiflu) Oral Suspension** 6 mg/ml, 60ml               1.61        0.99*        -0.62            0
 bottle.....................................................
Zanamivir (Relenza) 5 mg blisters..........................         19.2         16.4         -2.8          3.4
    Total...................................................        80.54        70.39       -10.15          3.4
----------------------------------------------------------------------------------------------------------------
* One treatment course = twice daily administration for five days
** Does not include 500K of old suspension formulation that is expired and is in quarantine and awaiting
  disposal.
\1\ The U.S. National Antiviral Strategy was updated in Jan 2014 and based on this revision, the target SNS
  goals for influenza antiviral stockpiling increased from 50M treatment courses to 80M treatment courses.

    This table shows current influenza antiviral products expiring 
between fiscal year 2016 and 2022 as well as the projected replacement 
costs for each fiscal year.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Product in               Projected replacement costs (millions of dollars)
                                                                  inventory ----------------------------------------------------------------------------
                                                                  expiring
                Medical countermeasure treatment                  2016-2022
                                                                 (treatment     2016       2017       2018       2019       2020       2021       2022
                                                                  courses)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Oseltamivir (Tamiflu) 75 mg capsules...........................       38.0M        .00        .00        .10      20.14      33.98     251.83     184.03
Oseltamivir (Tamiflu) 45 mg capsules...........................        3.2M        .00        .00        .65       1.33        .77       1.26       1.31
Oseltamivir (Tamiflu) 30 mg capsules...........................       11.8M        .00        .00       1.27       1.76       3.29       1.67       4.27
Oseltamivir (Tamiflu) Oral Suspension 12 mg/ml, 25ml bottle....       0.99M        .00       7.73        .00        .48        .00        .56       1.55
Zanamivir (Relenza) 5 mg blisters..............................       16.4M      90.64      72.95      31.81        .00        .00      37.19     122.37
    Total......................................................  ..........      90.64      80.68      33.83      23.71      38.04     292.51     313.53
--------------------------------------------------------------------------------------------------------------------------------------------------------

               strategic national stockpile replenishment
    Question. The initial efforts to prepare for and fund the National 
Strategy for Pandemic Influenza cost billions. How does the CDC 
envision paying for the cost of replenishing the antiviral stockpile? 
What is the cost estimate to replenish?
    Answer. Projections for expiring product are incorporated into the 
Public Health Emergency Medical Countermeasures Emergency (PHEMCE) 
Multiyear Budget to inform enterprise decisionmaking and allow for 
effective prioritization of medical countermeasure procurement in the 
Strategic National Stockpile (SNS) and across the participating PHEMCE 
agencies. These recommendations help inform the President's Budget 
request for the SNS, while recognizing that the request must balance a 
number of competing priorities. This will allow CDC to maintain SNS 
Readiness to support response to pandemic influenza and other threats 
to health security.
    This table shows current influenza antiviral products expiring 
between fiscal year 2016 and 2022 as well as the projected replacement 
costs for each fiscal year.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Product in               Projected replacement costs (millions of dollars)
                                                                  inventory ----------------------------------------------------------------------------
                                                                  expiring
                Medical countermeasure treatment                  2016-2022
                                                                 (treatment     2016       2017       2018       2019       2020       2021       2022
                                                                  courses)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Oseltamivir (Tamiflu) 75 mg capsules...........................       38.0M        .00        .00        .10      20.14      33.98     251.83     184.03
Oseltamivir (Tamiflu) 45 mg capsules...........................        3.2M        .00        .00        .65       1.33        .77       1.26       1.31
Oseltamivir (Tamiflu) 30 mg capsules...........................       11.8M        .00        .00       1.27       1.76       3.29       1.67       4.27
Oseltamivir (Tamiflu) Oral Suspension 12 mg/ml, 25ml bottle....       0.99M        .00       7.73        .00        .48        .00        .56       1.55
Zanamivir (Relenza) 5 mg blisters..............................       16.4M      90.64      72.95      31.81        .00        .00      37.19     122.37
    Total......................................................  ..........      90.64      80.68      33.83      23.71      38.04     292.51     313.53
--------------------------------------------------------------------------------------------------------------------------------------------------------

                        phemce multi-year budget
    Question. The PHEMCE Multi-Year Budget released last March proved 
very helpful in developing the fiscal year 2016 appropriations 
allocation for the Project BioShield Special Reserve Fund. Can you 
provide any details regarding when this year's Multi-Year Budget will 
be released? And will this year's Budget include much-needed 
information on pandemic influenza, which was not included last year?
    Answer. HHS develops the Multi-year Budget in response to the 
Reauthorization Act of 2013 (PAHPRA), which amended the Public Health 
Service Act to require the Assistant Secretary for Preparedness and 
Response to lead the development of a coordinated 5-year budget plan 
and annually update the plan. This report covers the Public Health 
Emergency Medical Countermeasures Enterprise (PHEMCE) estimates for 
spending in fiscal year 2015-fiscal year 2019 based on professional 
judgment on these programs. The report describes the importance of 
programs that address specified threats identified through the Material 
Threat Determination process used to set strategic requirements for 
medical products. Projected estimates are based on specific assumptions 
to maintain current preparedness efforts and projections are made 
without consideration of other competing priorities that are reflected 
in the formulation of the President's Budget. This year's multi-year 
budget on PHEMCE will include additional information on pandemic 
influenza. HHS is in the final phase of finalizing the report for 
transmission to Congress.
         zika virus response (genetically modified mosquitoes)
    Question. The Zika Supplemental requests funding for vector control 
activities. Is the Department exploring opportunities related to 
genetically modified mosquitoes to suppress the population of wild 
mosquitoes carrying Zika? Has the Department examined the possibility 
of deploying this technology in the United States, U.S. territories, or 
other countries?
    Answer. Yes, the Department is exploring opportunities related to 
using a genetically engineered (GE) line of the mosquitoe Aedes aegypti 
to help suppress the population of wild type mosquitoes known to 
transmit potentially debilitating human viral diseases, including Zika 
virus, dengue, yellow fever and chikungunya. As you know, there has 
been much interest in this proposal and we are working to ensure that 
we meet applicable National Environmental Policy Act (NEPA) 
requirements to ensure that the interested and affected public is 
informed.
    There has been public discussion about this new method to 
potentially help control mosquito populations through the use of a GE 
line of the mosquito Aedes aegypti (OX513A) developed by Oxitec, Ltd. 
The release of male Oxitec GE mosquitoes is intended to cause 
suppression of the mosquito population in a release area over time 
because the offspring resulting from the mating of male GE mosquitoes 
with wild type females do not develop to adulthood. Oxitec is seeking 
to conduct a field trial to determine whether the release of its GE 
mosquito will suppress the local Aedes aegypti mosquito population in 
the release area at Key Haven, Florida.
    The NEPA requires Federal agencies to assess the environmental 
impacts of certain actions. Pursuant to Food and Drug Administration 
(FDA) regulations, sponsors opening an Investigational New Animal Drug 
(INAD) file must submit either a draft environmental assessment (EA) or 
a claim of categorical exclusion from the EA requirement. The FDA also 
released a preliminary finding of no significant impact (FONSI) that 
agrees with the draft EA's conclusion that the field trial of such GE 
mosquitoes will not result in significant impacts on the environment.
    After the close of the required 30-day public comment period, FDA 
will review and consider relevant comments. The FDA will then either 
issue a final EA and FONSI, or prepare an environmental impact 
statement (EIS). The field trial cannot begin until the environmental 
assessment is complete. Once FDA has issued either a final EA and FONSI 
or an EIS, the company and its local partner (the Florida Keys Mosquito 
Control District) will decide when to begin the field trial.
            community behavioral health clinic demonstration
    Question. Madam Secretary, the budget's mental health initiative 
requests funding for six additional States to join the Community 
Behavioral Health Clinic Demonstration which is based on my Excellence 
in Mental Health Act. I believe that if you treat mental health like 
all other health, and if those suffering from a mental illness have 
access to care we would see overall healthcare costs go down. Can you 
speak to any healthcare savings we might see if we expanded access to 
care? How much cost savings would result in healthcare expenditures in 
the future by supporting all 24 States that currently have the planning 
grants?
    Answer. Thank you for your leadership on this legislation and your 
continued engagement in the demonstration project. We are excited about 
the Community Behavioral Health Clinic Demonstration and confident that 
it will promote high quality, community-based services for mental and 
substance use disorders. We are hopeful that the demonstration will 
show both the benefits of increased access to behavioral health 
services and coordination of behaviorial health services with primary 
care services, and the potential savings that could result from earlier 
treatment of a variety of conditions. However, at this stage in the 
demonstration, it is not possible to reliably predict the extent of any 
savings.
                       durable medical equipment
    Question. Rural providers of Durable Medical Equipment, 
Prosthetics, Orthotics, and Supplies (DMEPOS) are facing payment 
reductions between 30 and 50 percent from the Center for Medicare and 
Medicaid Services (CMS) under Round 3 of Competitive Bidding. These 
reductions are currently being phased in over a six month timeframe. In 
the past, CMS has provided multiyear transition. Why is CMS applying 
such an expedited phase-in for these suppliers who provide important 
medical equipment and services that allow patients to remain in their 
home?
    Answer. Section 1834(a)(1)(F)(ii) of the Social Security Act, as 
added by section 6410(b) of the Affordable Care Act of 2010, requires 
that CMS adjusts the DMEPOS fee schedule rates for competitive bid 
items using information from the DMEPOS competitive bidding program 
beginning January 1, 2016. We are phasing in these adjustments to the 
payment amounts to allow time for suppliers to adjust to the new 
payment rates and would allow time to monitor the impact of the change 
in payment rates on access to items and services. We believe a phase in 
of 6 months provides suppliers with an adequate amount of time to make 
adjustments to their businesses in light of the reduced payment 
amounts. In addition, CMS will be closely monitoring access and health 
outcomes using real time claims data and analysis during this period. 
If there are any issues identified through our monitoring, we will take 
appropriate actions depending on the situation.
    Question. As part of the final rule establishing the modified fee 
schedule, CMS indicated that they will monitor the impact of the rate 
reductions using real-time data. What specific data does CMS plan to 
use?
    Is there a delay in data and if so, how will CMS address that delay 
given the abbreviated phase-in timeframe?
    What specific criteria will CMS use to assess whether these 
reductions have interfered with patient access?
    Answer. CMS has been using a real-time claims analysis to monitor 
health status results in the DME competitive bidding program and other 
Medicare payment systems. The analysis for the DME competitive bidding 
program includes key indicators of the health status of beneficiaries 
and their access to DMEPOS items and services such as deaths, 
hospitalizations, emergency room visits, physician visits, admissions 
to skilled nursing facilities, average number of days spent 
hospitalized in a month, and average number of days in a skilled 
nursing facility in a month. We also monitor beneficiaries who no 
longer have claims for a competitively bid item after the program 
began, beneficiaries who may at some point need the item, and 
beneficiaries who currently have claims for competitively bid items. 
CMS is doing a similar type of analysis and monitoring for the adjusted 
DME fee schedule rates during the 6-month transition period and after 
this transition period. In addition, CMS will be monitoring assignment 
rates of suppliers. Assignment means that the suppliers have agreed to 
accept Medicare allowed rate as full payment for the DME item.
    Question. If suppliers are unable to continue caring for patients 
due to these reductions, will there be options for rural patients to 
continue to receive access to supplies and services in their home?
    Answer. CMS established a special rule for adjusting fee schedule 
amounts used in making payment for the item or service in areas within 
the contiguous United States that are defined as ``rural'' areas. For 
the purpose of implementing this rule, a rural area is defined as a 
geographic area represented by a postal zip code if at least 50 percent 
of the total area included in the zip code is outside any Metropolitan 
Statistical Area. In addition, a rural area includes a geographic area 
represented by a postal zip code that is a low population density area 
excluded from a competitive bidding area. For these areas, in no case 
will a fee schedule amount for any DMEPOS item furnished in the area be 
reduced below the national ceiling amount, which is 110 percent of the 
average of the regionally adjusted rates.
    CMS will be closely monitoring access and health outcomes using 
real time claims data and analysis during this period. If there are any 
issues identified through our monitoring, we will take appropriate 
actions depending on the situation.
            fiscal year 2017 medicare advantage rate notice
    Question. On February 19, 2016, as a part of the fiscal year 2017 
Medicare Advantage Rate Notice, the Center for Medicare and Medicaid 
Services (CMS) proposed a reduction to Medicare Advantage Employer 
Group Waiver Plans (EGWPs), also known as Medicare Advantage Retiree 
Coverage. 3.3 million seniors, including nearly 37,000 Missourians, 
receive their Medicare Advantage coverage through these plans. While 
producing an analysis of the impact of many provisions proposed in the 
Advance Notice, CMS did not provide an impact analysis on these 
proposed reductions. On March 7, 2016, CMS released an impact analysis 
confirming a negative 2.5 percent cut to Medicare Advantage Retiree 
Coverage. The information was released after the comment period was 
closed, which ensures that the public is unable to comment on the new 
information. A Milliman report and an Oliver Wyman Report both provided 
similar estimates to CMS's impact analysis. Did CMS consider the impact 
the reductions to Medicare Advantage Retiree Coverage would have on the 
3.3 million seniors who depend on this form of coverage when developing 
the Advance Notice?
    Answer. Employer Group Waiver Plans (EGWPs) serve specific employer 
groups, and are either offered through negotiated arrangements between 
Medicare Advantage plans and employer groups or by the employer 
directly. Because of the nature of these unique agreements, EGWPs do 
not compete against other plans through the bidding process, and 
therefore have little incentive to submit lower bids. CMS has 
previously waived bidding requirements for Part D for EGWPs and set 
payment amounts for Part D plans based on the competitive bids 
submitted for non-EGWP Part D plans. In the 2017 Draft Call Letter, CMS 
proposed a similar waiver and payment policy for EGWP Part C plans for 
2017. This proposal would provide Medicare Advantage EGWP plans with a 
fair benchmark, reflective of comparable local Medicare Advantage 
trends and prices. CMS believes that waiving the requirement to submit 
2017 Part C bids will facilitate the offering of Part C plans for 
employers and unions seeking to establish high quality coverage for 
their Medicare eligible retirees by avoiding the cost and 
administrative burden of submitting complex bids. CMS will consider 
comments we receive on this and other proposals in the draft Call 
Letter.
    Question. Why did CMS fail to include this cut in the agency's 
calculation of the overall Medicare Advantage Advance Notice impact 
analysis initially?
    Answer. In the Advance Notice of Methodological Changes for 
Calendar Year 2017 for Medicare Advantage Capitation Rates, Part C and 
Part D Payment Policies, which was released on February 19th, CMS 
proposed to change the methodology for Part C payments to Employer 
Group Waiver Plans (EGWPs) without providing an estimated impact. 
Impacts are not always provided for all proposed changes in the advance 
notice. In response to subsequent inquiries regarding the impact of the 
proposal, we provided an estimate of the expected impact of the 
proposed change for Part C payments to EGWPs.
                         unaccompanied children
    Question. In the summer of 2014 there was a sudden and significant 
increase in children coming to the United States from Central America. 
There was then a sudden decrease at the end of 2014 through most of 
2015, another significant increase at the end of 2015, and now a 
decrease through the beginning of 2016. What is causing these 
significant swings? Has the situation in Central America changed over 
this time? Has Mexico's enforcement strategy changed over this time?
    Answer. HHS receives regular briefings from the intelligence 
agencies on conditions in Central America. We know that many of the 
unaccompanied children crossing the U.S. border are fleeing poverty and 
violence, or seeking to rejoin their parents or close relatives. 
However, interagency partners' analysis on the situation on the ground 
does not indicate that conditions in these countries have changed in 
ways that can easily explain the volatile fluctuations in the number of 
children coming to the United States. The Office of Refugee 
Resettlement (ORR) is involved in ongoing operational communication 
with partners to monitor and analyze trends and works with several 
components of the Department of Homeland Security on a daily basis on 
the referral and transport of unaccompanied children from the border to 
ORR shelters.
    Question. These significant swings in the number of children coming 
to the United States from month-to-month makes it difficult for HHS to 
budget for the unaccompanied children program, but it also makes it 
difficult for this Committee to judge budget requests. How is the 
Department coordinating between different Departments to get a better 
grip of the trends driving the fluctuations in children coming into 
this country?
    Answer. The Office of Refugee Resettlement (ORR) continuously 
monitors and analyzes the trends of referrals of unaccompanied children 
to HHS custody. In addition, ORR engages with interagency partners on a 
regular basis to better understand migration trends and the 
sociopolitical dynamics currently existing within the home countries. 
ORR coordinates with interagency partners through the Unified 
Coordination Group (UCG) created in 2014 in response to a Presidential 
directive to ensure unity of effort across the executive branch in 
response to the sharp increase of unaccompanied children arriving at 
the southwest border at that time. Since then, the UCG has continued to 
meet regularly to continue coordinating to plan for and respond to 
shifts in numbers of unaccompanied children. ORR also works with 
several components of the Department of Homeland Security on a daily 
basis on the referral and transport of unaccompanied children from the 
border to ORR shelters. ORR also coordinates with staff at the 
Department of Justice (DOJ), the General Services Administration (GSA), 
the Department of Defense (DOD) and the State Department on various 
aspects of the unaccompanied children program that intersect with their 
operations and responsibilities. UCG members routinely compare trends 
with historic annual and seasonal patterns. Given how much the number 
of unaccompanied children has fluctuated in the last couple of years, 
it is difficult to accurately predict the number of children that would 
be referred to ORR.
    Given the range of external factors that may affect the number of 
children coming into HHS care, it would be prudent for Congress to 
provide access to additional funding that would allow ORR to 
accommodate higher than expected caseloads. For instance, referrals to 
the unaccompanied children program in fiscal year 2014 were the highest 
on record for the program, requiring the deployment of temporary 
shelter facilities as well as the expansion of standard shelter 
capacity. However, referrals to the program in fiscal year 2015, though 
still the second highest year on record, were substantially lower than 
the prior year, and allowed ORR to reduce the costs associated with 
shelter budgets during the low season referrals. Referrals in the first 
quarter of fiscal year 2016 were significantly higher than during the 
same period in previous years. While they decreased significantly in 
the second quarter of the current fiscal year, they still exceed second 
quarter referral levels for every prior year except for fiscal year 
2014. Since mid-March, we have begun to see the numbers rise again.
    These fluctuations in just this fiscal year alone underscore the 
unpredictable nature of referral numbers, and creates serious 
operational challenges for ORR as they budget for beds across the 
fiscal year. The President's fiscal year 2017 budget request creates a 
contingency fund that would trigger additional funds, not to exceed 
$400,000,000, if referrals were higher than could be supported with 
base program funds and any carry over funds for the program from the 
prior year. The Administration estimates that the cost of the 
contingency fund in fiscal year 2017 would be $95,000,000 based on the 
probability that additional funds would be outlayed.
    The lack of contingency funds in fiscal year 2016 has hindered 
HHS's ability to plan for a full range of scenarios including having 
the number of unaccompanied children coming into its care increase 
significantly during the latter part of the fiscal year. While base 
budgetary resources are sufficient to accommodate a significant 
increase over current referrals, if the number of referrals spiked 
suddenly to levels above those seen in fiscal year 2014, resources 
could prove inadequate. If such a spike were to occur late in the year, 
when it would be difficult for Congress to respond, HHS could be left 
with insufficient resources to house these children. This is why a 
contingency fund mechanism is so critical to ensuring that if an 
unexpected increase in referrals occurs, the Federal Government is 
equipped to provide appropriate care to children. We welcome the 
opportunity to explore these issues further with the Committee and 
discuss mechanisms that would ensure that HHS has the resources 
necessary should an unexpected increase, particularly one that occurs 
late in the year, arise.
             funding for early childhood care and education
    Question. The fiscal year 2017 budget request includes significant 
increases in funding for Head Start, the Child Care and Development 
Block Grant (CCDBG), and Preschool Development Grants. Particularly now 
that Preschool Development Grants are funded within HHS, what is the 
Department doing to ensure these programs are well coordinated at the 
Federal, State, and local level and that we aren't duplicating efforts?
    Answer. The Department of Health and Human Services (HHS) and 
Department of Education will continue to jointly administer the 
Preschool Development Grants program in 2017 and beyond HHS has worked 
closely with our colleagues at the Department of Education to ensure 
that our programs are coordinated, serve our Nation's children as best 
as possible, and create a continuum of high-quality early learning 
services beginning at birth and continuing through age five.
    The Departments have had success in the joint administration of 
Race to the Top-Early Learning Challenge and Preschool Development 
Grants in previous years and engage in numerous other activities to 
ensure coordination at all levels. For example, the Departments co-
chair an Interagency Policy Board on Early Learning, that coordinates 
policy, programs, research, and technical assistance across agencies 
and issues joint policy statements on key issues, including the 
inclusion of young children with disabilities in classrooms and 
programs with typically developing peers and preventing and eliminating 
the expulsion of young children from early childhood programs. Other 
examples of collaboration include the joint development of Birth to 
Five: Watch Me Thrive, which provides a toolkit to increase rates of 
developmental screening and follow-up and dissemination of materials 
highlighting how to utilize Medicaid to support creating school 
environments with physical and mental health supports.
    We appreciate the importance of close coordination in the joint 
administration of the Preschool Development Grants Program, and will 
continue to keep your staff updated as we proceed with planning and 
implementation.
    Question. The Department has proposed regulations that would 
increase the length of the Head Start school day and year, to increase 
the duration of services provided, which is consistent with research on 
what characteristics of early childhood education are most important. 
Similarly, the CCDBG Act of 2014 includes important reforms that 
require States to take steps to improve the quality of child care 
programs. In light of these important and costly proposed reforms, why 
has the budget proposed a $100 million increase for Preschool 
Development Grants, and not focused all available resources on changes 
underway in Head Start and CCDBG?
    Further, why has the budget proposed $40 million of the increase 
for CCDBG for a new competitive grant program instead of focusing those 
resources on State efforts to comply with the new requirements in the 
CCDBG Act?
    Answer. We appreciate your work on the passage of the Child Care 
and Development Block Grant Act of 2014 and your continuing support for 
implementing the law's new provisions. The fiscal year 2017 Budget 
includes an increase of about $200 million for the Child Care and 
Development Block Grant (CCDBG), and the majority of this increase is 
focused on helping States and communities to implement the new 
requirements of the law. Of the total increase, $40 million will be 
used for competitive grants to States, territories, tribes, local 
governments, and public entities to develop, implement, and evaluate 
approaches and innovative models of providing the types of care that 
working families need most. These grants are part of CCDBG, rather than 
a separate program. The focus will be on two areas: (1) care during 
non-traditional hours, and (2) care in rural areas. This funding is 
fully in line with the reauthorized CCDBG Act, which included a 
provision that requires States to develop and implement strategies to 
increase the supply and improve the quality of child care services for 
certain populations, including children in underserved areas (which may 
include rural areas) and children who receive care during 
nontraditional hours. The goal of these pilot grants is to help States 
and communities to meet this new provision, as well as other provisions 
in the law.
    Despite large numbers of families with non-traditional work hours, 
the National Survey of Early Care and Education found that only 8 
percent of center-based early care and education programs offered 
services during non-standard hours. Home-based providers are more 
likely to provide non-standard hour care, yet such care was only 
available from 34 percent of home-based providers who appear in 
official State and national lists of early care and education services. 
Families living in rural communities also face unique challenges when 
accessing high-quality child care due to the lack of affordable child 
care, lack of public transportation, and the longer distances families 
must travel between work, home, and child care settings.
    These pilots will provide dedicated resources that will support 
States and communities to identify and implement innovative solutions 
to serving these populations and populations specified by Congress as 
critical to address. The lessons learned from these pilots can then 
inform nationwide efforts to meet the goal of the CCDBG reauthorization 
legislation directing States to increase supply for underserved 
populations.
    The Budget also requests a total of $9.6 billion for Head Start, an 
increase of about $434 million from 2016. This increase includes $142 
million for a full cost-of-living adjustment for all grantees, 
including Early Head Start-Child Care Partnership grantees. This 
funding would ensure that Head Start and Early Head Start grantees can 
maintain the number of children served and the quality of their 
program. The increase also includes an additional $292 million over 
2016 to enable more Head Start programs to offer full school day and 
year services, which, as you mentioned, is based in high-quality early 
childhood education research.
    The increase in Preschool Development Grants is necessary to expand 
upon the efforts already underway in the 18 States that make up the 
first cohort of grantees. This additional funding would enable HHS and 
ED to fund new grants under the reauthorized Elementary and Secondary 
Education Act (ESEA) program in addition to supporting the final year 
of continuation grants for the first cohort. The new grants will 
improve the overall quality of preschool programs while improving 
coordination across early learning systems and increasing parent choice 
and knowledge about these programs. Ultimately, if all children are to 
have access to high quality pre-K programs, State efforts must be 
supported. This investment will also support and enhance many of the 
activities required under the reauthorized Child Care and Development 
Block Grant.
    The fiscal year 2017 Budget request reflects the Administration's 
overall strategy to expand access to high quality early learning 
programs by improving the quality of existing programs and expanding 
the availability of high quality pre-K opportunities. This means 
investing in Head Start and child care while helping States to build 
high quality pre-K opportunities for 4 year olds.
    Question. What does the Department estimate is the total cost to 
States in fiscal year 2017 to implement changes in the CCDBG Act?
    Answer. In December 2015, HHS proposed revisions to the program 
regulations to reflect the changes contained in the Child Care and 
Development Block Grant Act of 2014. The Notice of Proposed 
Rulemaking's regulatory impact analysis estimated the average annual 
cost of full implementation at $1.1 billion. Of this total, only $5 
million in costs stem from areas where HHS interpreted the statute and 
proposed clarifications through regulation, including applying 
background checks to regulated and registered child care providers and 
non-caregivers. As you know, the child care program is supported by a 
combination of Federal and State dollars, with, on average, 60 percent 
of the funds coming from the Federal funding streams. The Department is 
committed to supporting States through technical assistance and 
additional resources as they implement the law's requirements.
                                 ______
                                 
               Questions Submitted by Senator Jerry Moran
                hrsa telehealth resource centers program
    Question. What changes is HHS, specifically HRSA, considering to 
the HRSA Telehealth Resource Centers program, which supports regional 
Centers across the United States? If changes are being considered to 
this program and/or current Centers, what steps are being taken by HHS 
and HRSA to ensure the continuation of existing Centers and the 
integral role they have in helping expand access to underserved 
populations? Are there plans to maintain support for the current 
Telehealth Resource Centers and ensure any updates to the program build 
on important Federal investments already made to these important 
Centers across the U.S.?
    Answer. The fiscal year 2017 President's Budget includes $17 
million for Telehealth Grants. The Telehealth program expands the use 
of telecommunications technologies within rural areas that can link 
rural health providers and patients with specialists to increase access 
to, and the quality of, healthcare provided to rural populations. These 
grants support the Improving Rural Health Care Initiative by 
strengthening rural healthcare infrastructure. Of the $17 million 
total, $4.6 million will be used to maintain support of regional 
Telehealth Resource Centers, which provide technical assistance to 
communities striving to establish or enhance and expand telehealth 
services. HRSA does not plan to make major changes to the Telehealth 
Resource Centers program in fiscal year 2017, as it will continue to 
support the regional Centers.
                                 ______
                                 
              Questions Submitted by Senator Thad Cochran
          preventative health and health services block grant
    Question. I am concerned about the proposed elimination of the 
Preventative Health and Health Services Block Grant (PHHSBG). In 
Mississippi, we use these funds to fluoridate water and to fund health 
educators, among other things. What other resources at HHS would 
provide these important activities such as fluoridation and health 
educators if the PHHSBG is eliminated?
    Answer. As you stated, the fiscal year 2017 Budget request 
eliminates the Preventive Health and Health Services Block Grant 
(PHHSBG). We believe these activities may be more effectively and 
efficiently implemented through State and local chronic disease 
funding, which provides resources to States to coordinate activities 
across categorical funding streams. For example, the Centers for 
Disease Control and Prevention's (CDC) has requested $18 million for 
oral health programs to support fluoridation and other oral health 
activities, continuing the $2.25 million increase appropriated in 
fiscal year 2015. 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, oral health, immunizations, 
and obesity, and many States did not receive funding from CDC to 
support prevention of chronic disease. However, since 1981, categorical 
programs at CDC have grown and can better address these public health 
threats. Given the limited funding environment and our commitment to 
investing in the highest-priority, evidence-based programs, elimination 
of this program allows us to increase funding for key areas where CDC 
can have the greatest impact, including combating antibiotic-resistant 
bacteria and expanding the fight against opioid misuse, abuse, and 
overdose.
mobilization for health: national prevention partnership awards program
    Question. What types of programs were funded under the Mobilization 
for Health: National Prevention Partnership Awards Program administered 
by the Office of Assistant Secretary for Health? It is my understanding 
that this particular program was last competed in fiscal year 2014. 
What are the Department's plans for this program going forward?
    Answer. The Office of the Assistant Secretary for Health (OASH) 
made 13 grant awards in fiscal year 2014 through the Mobilization for 
Health: National Prevention Partnership Awards (NPPA) Program. This 
funding opportunity created a network of partnerships and resources to 
promote health and wellness, educate and train, and establish 
communication programs to all community populations, regardless of 
social and economic barriers, race, and ethnicity. These awards are for 
a 3 year project period
    NPPA projects addressed an array of OASH priorities, including: 
preventing teen pregnancy among Latino families by engaging community 
health workers/promotores; improving access to preventive healthcare 
services among limited English speaking families by strengthening links 
among school, home and medical settings; and improving clinical 
preventive services among the elderly by increasing the capacity of 
existing networks of community-based health, service, and business 
organizations.
    OASH will continue to monitor and assess these projects to 
determine future funding opportunities. We will keep your staff 
updated.
                           dme reimbursement
    I am concerned about the short timeframe that the Centers for 
Medicare and Medicaid Services (CMS) has laid out for expanding 
competitive bidding for durable medical equipment to rural areas. As 
you know, my State of Mississippi is largely rural and, as a result, 
Mississippians face many challenges in accessing healthcare. Why does 
HHS believe that these competitive bidding rates, which will cut DME 
reimbursement by 30 to 50 percent by July 1 of this year, will not 
further impede access to quality healthcare for Americans living in 
rural areas? What are CMS's plans, including the timeline, to collect 
pertinent data to determine effects on access?
    Answer. CMS has been using a real-time claims analysis to monitor 
health status results in the DME competitive bidding program and other 
Medicare payment systems. The analysis for the DME competitive bidding 
program includes key indicators of the health status of beneficiaries 
and their access to DMEPOS items and services such as deaths, 
hospitalizations, emergency room visits, physician visits, admissions 
to skilled nursing facilities, average number of days spent 
hospitalized in a month, and average number of days in a skilled 
nursing facility in a month. We also monitor beneficiaries who no 
longer have claims for a competitively bid item after the program 
began, beneficiaries who may at some point need the item, and 
beneficiaries who currently have claims for competitively bid items. 
CMS is doing a similar type of analysis and monitoring for the adjusted 
DME fee schedule rates during the 6-month transition period and after 
this transition period. In addition, CMS will be monitoring assignment 
rates of suppliers. Assignment means that the suppliers have agreed to 
accept Medicare allowed rate as full payment for the DME item. If there 
are any issues identified through our monitoring, we will take 
appropriate actions depending on the situation.
               non-invasive positive pressure ventilation
    Question. It is my understanding that the National Coverage 
Determination (NCD) currently in place covers Non Invasive Positive 
Pressure Ventilation (NIV) for patients with neuromuscular diseases, 
restrictive thoracic diseases, and/or chronic respiratory failure 
consequent to chronic obstructive pulmonary disease (COPD). CMS is 
currently requiring that a patient be on NIV machine 24/7 in order to 
for the NIV to be covered under Medicare. What is the medical 
justification for this requirement? Is there medical benefit to NIV for 
less than 24/7? Is CMS in violation of the NCD for patients with the 
specified conditions?
    Answer. A Medicare National Coverage Determination (NCD) is 
developed by CMS to describe the circumstances for Medicare coverage 
nationwide for an item or service. An NCD is binding on all Medicare 
contractors in making determinations on Medicare claims and on 
adjudicators during the Medicare claims appeal process. Under the NCD, 
ventilators are covered for treatment of neuromuscular diseases, 
thoracic restrictive diseases, or chronic respiratory failure 
consequent to chronic obstructive pulmonary disease, including both 
positive and negative pressure types. In making coverage 
determinations, the Medicare contractors may consider criteria that 
would account for the reasonable and necessary use of a ventilator in 
order to avoid risk to the patient's health in a claim by claim 
adjudication.
                       critical access hospitals
    Question. It is my understanding that, during the process of 
recertification, several CAHs in Mississippi have been asked to produce 
the original letters they received when they originally obtained the 
CAH status. This could be a substantial administrative burden on these 
small rural hospitals, requiring many of them to comb through decades 
of files. What is the justification for this requirement? Did CMS 
consider the burden on CAHs when instituting this requirement? Will CMS 
offer other alternatives to the original recertification letter?
    Answer. Response: Thank you for your ongoing leadership on this 
critical issue. I understand firsthand the challenges of healthcare in 
rural America. Critical access hospitals provide valuable services to 
Americans in rural areas, and we are committed to reducing 
administrative burdens while meeting requirements outlined in statute.
    Thank you for your ongoing leadership on this critical issue. I 
understand the challenges of healthcare providers in rural America. 
Critical access hospitals provide valuable services to Americans in 
rural areas, and we are committed to reducing administrative burdens 
while meeting requirements outlined in statute.
    Section 1820(c)(2)(B) of the Social Security Act (the Act) requires 
a Critical Access Hospital (CAH), other than a necessary provider CAH, 
to be located in a rural area, more than a 35-mile drive (or 15 miles 
in areas with only secondary roads or mountainous terrain) from a 
hospital or another CAH. CMS regulations repeat this statutory 
requirement.
    The Office of Inspector General (OIG) report entitled, ``Most 
Critical Access Hospitals Would Not Meet the Location Requirements if 
Required to Re-enroll in Medicare,'' recommended that CMS periodically 
reassess CAHs' compliance with all location-related requirements. CMS 
concurred with the recommendation. Also consistent with OIG 
recommendations, CMS determined to provide a 1 year transition period 
for any CAH that would have its CAH status revoked due to such a 
reassessment.
    The OIG subsequently called on CMS to maintain evidence that it is 
routinely re-evaluating the compliance of currently Medicare-certified 
CAHs with these status and location requirements. In order to 
facilitate this, CMS has developed the CAH Recertification Checklist: 
Rural and Distance or Necessary Provider Verification for use by the 
CMS Regional Office staff, which includes the requirement to retain the 
original letter.
    CMS Regional Offices use this checklist to determine if the CAH is 
located outside the Metropolitan Statistical Area (MSA) by consulting 
the OPM's latest MSA list. If the CAH had been certified as a Necessary 
Provider, it is exempt from the distance requirements.
    Question. Providers in my State have contacted me with their 
concerns about how slow the Medicaid credentialing process is with 
Managed Care Organizations (MCOs). Why can't MCOs accept a provider's 
State Medicaid credentialing? Has CMS examined the whether MCOs take 
too long in credentialing providers?
    Answer. Credentialing is the process the managed care organizations 
(MCOs) use to ensure that providers are qualified and meet the MCO's 
quality standards for healthcare providers. CMS regulations require 
States to establish a uniform credentialing and re-credentialing policy 
that each MCO must follow. Nothing prohibits a State and the MCOs from 
using a common credentialing process. CMS has not examined the length 
of time that it takes MCOs to credential providers; MCOs' credentialing 
process is an activity that falls within a State's normal contract 
oversight.
                        long-term care hospitals
    Question. The Senate report for the fiscal year 2016 appropriations 
bill included the following language on page 149:

      Severe Wounds.--The Committee directs the Secretary, in 
        consultation with relevant stakeholders, to conduct a study on 
        the treatment needs of individuals entitled to benefits under 
        part A, or enrolled under part B, of Medicare, requiring 
        specialized wound care, and the cost, for such individuals and 
        the Medicare program, of treating severe wounds in rural and 
        urban areas. The study shall include an assessment of: (A) 
        access of such individuals to appropriate levels of care for 
        such cases; (B) the potential impact that section 
        1886(m)(6)(A)(i) of the Social Security Act (42 U.S.C. 
        1395ww(m)(6)(A)(i)) will have on the access, quality, and cost 
        of care for such individuals; and (C) how to appropriately pay 
        for such care under the Medicare program. The Secretary shall 
        submit the report within 1 year after enactment of this act to 
        the Committees on Appropriations of the House of 
        Representatives and the Senate with recommendations for such 
        legislation and administrative actions as the Secretary 
        determines appropriate.

    Madame Secretary, has HHS begun to prepare this report? If so, what 
steps have been taken and what future steps have been identified?
    Answer. HHS is reviewing the language, and will work to provide the 
report as directed. We will share the report with you as soon as it is 
completed.
   physician shortages and graduate medical education in rural areas
    Question. Mississippi faces physician shortages across the State, 
particularly in our small towns and rural communities. Research has 
shown that doctors most often practice in close proximity to where they 
complete their residency training, yet across the Nation, our physician 
residency slots are concentrated in metropolitan areas. What is HHS 
doing to increase the number of resident physicians training in small 
towns and rural communities? What role can Community Health Centers 
(CHCs) play in addressing this challenge? What is HHS doing to build 
the capacity for residency training within CHCs in our most rural 
underserved areas?
    Answer. HHS is committed to improving access to quality healthcare 
for rural Americans, and to expanding and strengthening the health 
workforce. The Budget provides a total of $1.3 billion for Health 
Resources and Services Administration (HRSA) workforce programs, 
including $715 million in mandatory funding to provide access to high-
quality healthcare professionals, particularly those living in areas 
across the country with shortages of providers. This funding includes 
investments in graduate medical education, the National Health Service 
Corps, and workforce diversity efforts. By addressing the shortage of 
primary care professionals that exists in certain parts of the country, 
HRSA health workforce programs play a critical role in making sure all 
Americans have access to high-quality healthcare.
    As you suggest, rural training track residency programs are a 
proven model for addressing rural physician workforce shortages. Rural 
training track residency programs provide graduate medical education to 
prepare resident physicians broadly for rural family medicine. As part 
of our efforts to strengthen the health workforce and connect skilled 
professionals to communities in need, HRSA operates two residency 
training programs that train and place healthcare providers in 
underserved areas across the Nation, including rural communities: the 
Teaching Health Center Graduate Medical Education Program and the 
Primary Care and Enhancement Program.
Teaching Health Center Graduate Medical Education Program
    The Teaching Health Center Graduate Medical Education Program 
provides funding for residency training in primary care medicine and 
dentistry in community-based, patient caresettings. In addition to 
increasing the number of primary care residents training in these 
community-based patient care settings, the Teaching Health Center 
Graduate Medical Education Program seeks to improve healthcare quality 
and increase overall access to care, especially in rural and 
underserved communities.
    Since the program's inception, nearly all residents received 
training in a medically underserved community, and just over 1 out of 
every 5 received training in a rural area.
    Of the 98 residents who completed the program in Academic Year 
2014-2015, approximately 34 percent intended to practice in a medically 
underserved area. This is an important programmatic accomplishment 
toward increasing the numbers of those practicing in rural areas, since 
physicians trained in rural areas tend to practice in rural areas.
    In fiscal year 2014, the East Central Mississippi Health Network, 
Inc. (EC-HealthNet), in Decatur, Mississippi, became a Teaching Health 
Center Graduate Medical Education awardee. The purpose of the EC-
HealthNet Residency Consortium is to train physicians in rural areas to 
increase the likelihood that they will 1) choose to practice in a rural 
area and 2) have the clinical philosophy and skills to care for rural 
residents. In fiscal year 2015, EC-HealthNet Residency Teaching Health 
Center received $880,099 in Teaching Health Center Graduate Medical 
Education funding to train 12 resident FTEs.
    The fiscal year 2017 President's Budget includes $60 million in 
already enacted mandatory funding in fiscal year 2017 and a request of 
$527 million for fiscal year 2018 through fiscal year 2020 to support 
876 residents, the currently approved number of residents in Teaching 
Health Center Graduate Medical Education programs. The funding request 
through fiscal year 2020 is critical for the sustainability of primary 
care residency programs which require up to 3 to 4 years per resident 
to complete training.
Primary Care Training and Enhancement Program
    The Primary Care Training and Enhancement Program focuses on 
training for transforming healthcare systems, and supports the clinical 
training experience of trainees in rural and underserved areas, as well 
as encourages interprofessional primary care education. In fiscal year 
2015, 49 percent of our Primary Care Training and Enhancement grantees 
were located in rural counties.
    The fiscal year 2017 Budget requests $38.9 million for the Primary 
Care Training and Enhancement Program to improve the quality of primary 
care providers, increase the capacity of physician assistant education 
programs, promote interprofessional practice, enhance medical education 
through curriculum innovations and improve the distribution and 
diversity of the healthcare workforce.
    The Primary Care Training and Enhancement Program includes a 
funding preference for applicants that demonstrate a high rate for 
placing graduates/program completers in medically underserved 
communities or a significant increase in the rate of placing graduates/
program completers in medically underserved community settings over the 
preceding 2 years. Applicants receiving the preference are placed in a 
more competitive position compared to other eligible applicants.
                              chronic pain
    Question. People across the country suffer from chronic pain, and 
there are some with pain so severe that opioid medication pills are no 
longer effective for them or put them at risk for addiction or 
diversion. For these patients, treatment with opioid medications via an 
implanted infusion pump is often a good alternative for pain 
management. These implanted infusion pumps slowly administer pain 
medication solutions into a patient's intrathecal space to control pain 
and reduce the need for opioid pain pills. CMS implemented Change 
Request (CR) 7397 in 2013, despite feedback from patients, physicians, 
and pharmacies across the country. This CR eliminated pharmacies' 
ability to bill Medicare Part B for pain medication solutions used to 
refill a patient's implanted infusion pump while in a doctor's office. 
The change in policy contained in CR 7397 prohibits pharmacies from 
billing Medicare for these solutions and requires that physicians ``buy 
and bill'' these solutions in order for Medicare to cover them for 
beneficiaries.
    Are you aware that many State boards of pharmacy, including 
Mississippi's, do not allow the practice of pharmacies selling 
compounded solutions to physicians or other third parties for resale to 
patients
    In your opinion, would the use of intrathecal pain pumps reduce the 
quantities of oral pain medication prescribed?
    Patients across the country have lost and are losing access to this 
treatment option since pharmacies can no longer bill Medicare directly 
and cannot legally sell the compounded medications to physicians. Would 
you be willing to publish a new Change Request implementing this 
change?
    Answer. HHS is committed to ensuring that the many Medicare 
beneficiaries across the country that suffer from chronic pain have 
access to the medications and treatments they need. In the Calendar 
Year 2013 Medicare Physician Fee Schedule final rule, CMS clarified 
longstanding policy that drugs used by a physician to refill an 
implanted item of DME were considered to be ``incident to'' a 
physician's services and not in the DME benefit category. Therefore, 
for the drug to be paid under Part B, the physician must buy and bill 
for the drug, and a non-physician supplier that has shipped the drug to 
the physician's office may not bill CMS separately. It was our 
understanding at the time the rule was written, that the majority of 
pharmacies in the country were in compliance with the physicians' ``buy 
and bill'' approach. We have not received reports that the situation 
has changed, nor have we received reports of significant access 
problems. CMS will continue to monitor this situation.
    As additional background, in order to be covered by Medicare Part A 
or Part B, an item or service must fall within one or more benefit 
categories within such Parts, and must not be otherwise excluded from 
coverage. Drugs and biologicals paid under Medicare Part B fall into 
three basic categories:
  --Drugs furnished ``incident to'' a physician's services. These are 
        typically injectable drugs that are bought by the physician, 
        administered in the physician's office, and then billed by the 
        physician to the Medicare Administrative Contractor (MAC). By 
        definition, ``incident to a physician's professional service'' 
        requires the item or service to be billed by the physician.
  --Drugs administered through a covered item of durable medical 
        equipment (DME). These drugs are supplies necessary for the 
        effective use of DME and are typically furnished to the 
        beneficiary by suppliers that are pharmacies (or general DME 
        suppliers that utilize licensed pharmacists) for administration 
        in a setting other than the physician's office. Most DME drugs 
        are billed to the DME MAC.
  --Other drugs specified by the statute, including a variety of drugs, 
        such as certain oral immunosuppressives and vaccines.
  --Depending on the circumstances, drugs used to refill an implanted 
        intrathecal pump can be paid under either ``incident to'' a 
        physician's services under Part B, under the DME benefit 
        category, or under Medicare Part D. We note that payment to 
        pharmacies (or suppliers) for drugs used to refill an implanted 
        pump can be made under the DME benefit category where the drug 
        is directly dispensed to a patient and the implanted pump is 
        refilled without a physician's service. However, it is our 
        understanding that implanted pumps are rarely refilled without 
        utilizing the service of a physician.
                         antibiotic resistance
    Question. Language was included in the fiscal year 2016 Senate 
report that highlights the significant effect of animal/human 
interactions on antibiotic resistant bacteria. I believe our strategies 
to combat antibiotic resistance must include both animals and humans. 
What are your immediate plans to develop such an effort to stimulate 
the synergy among academic medical centers and colleges of veterinary 
medicine to advance the science related to antibiotic resistance?
    Answer. I share your concern regarding the development of 
antimicrobial-resistant bacteria and agree this is a critically 
important public health issue. Over the past several years, HHS has 
taken important steps toward fundamental change in how medically 
important antibiotics can be legally used in feed or water for food 
producing animals.
    FDA is engaging in efforts to foster the advancement of education 
and research focused on antimicrobial resistance. As an example, FDA 
served in an advisory role to a task force that the Association of 
American Veterinary Medical Colleges (AAVMC) and the Association of 
Public and Land-grant Universities (APLU) formed to identify education 
and research needs. FDA's Center for Veterinary Medicine is also 
continuing to collaborate with AAVMC/APLU in the context of a working 
group convened to develop core competencies related to antimicrobial 
resistance for students at various levels. FDA believes that detecting 
and controlling antibiotic-resistance requires the adoption of a ``One-
Health'' approach to disease surveillance that recognizes that 
resistance can arise in humans, animals, and the environment. 
Collaborations with academic organizations are of critical importance 
for advancing good antibiotic stewardship principles that impact both 
human and animal health.
                          community pharmacies
    Question. It is my understanding that Medicare Part D prescription 
drug plan sponsors may contract auditing of pharmacies to large 
pharmacy companies like CVS Caremark. I am concerned that these 
contracts may present a conflict of interest as a pharmacy chain's 
parent company audits prescriptions filled by its competitors. Does CMS 
approve these contracts, or are they purely at the discretion of the 
Medicare Part D prescription drug plan sponsor? What CMS policies are 
in place to ensure that there is no conflict of interest in these 
auditing contracts?
    Answer. The Part D regulations obligate Part D plan sponsors to 
adopt and implement an effective compliance program, which must include 
measures that prevent, detect, and correct a sponsor's non-compliance 
with Part D program requirements as well as prevent and detect fraud, 
waste, and abuse. A sponsor's compliance program must include a plan 
for the performance of internal and external audits. In Chapter 9 of 
the Medicare Prescription Drug Benefit Manual (``Compliance Program 
Guidelines''), CMS provides guidance to sponsors on the effective 
administration of their compliance plans, including the conduct of 
audits. In particular, CMS instructs sponsors that they must ensure 
that their auditors are independent and do not engage in self-policing. 
Also, CMS instructs sponsors to develop a strategy for auditing their 
first tier entities to make certain that such entities are monitoring 
their downstream entities properly.
    Many Part D sponsors contract with large pharmacy benefit managers 
(PBMs) to perform, among other things, claims processing and network 
contracting functions, on their behalf. In some instances, these PBMs 
are the corporate relatives of large pharmacy chains. In these 
arrangements, the PBMs are first tier entities to the Part D sponsor, 
while the sponsor's network pharmacies are downstream entities to the 
PBMs. Plan sponsors may also include in their PBM contracts provisions 
requiring the PBM to audit the operations of the pharmacies 
participating in the sponsor's Part D plans. CMS does not review or 
approve these contracts.
    Sponsors using their PBM to conduct their pharmacy audits are 
responsible for ensuring that the PBM will conduct their audits in an 
independent manner. Since sponsors remain accountable to CMS for their 
compliance with all Part D requirements, it is in their interest to 
ensure pharmacy audits provide the full picture of their contracted 
pharmacy operations. Also, the Part D program's capitated payment 
structure places the financial burden on the sponsors to scrutinize 
closely the claims paid at all its contracted pharmacies, without 
exceptions. Further, to comply with Part D program requirements 
described above, sponsors need to conduct their own ``audit of the 
auditor'' to confirm that the first tier auditing entity (e.g. the PBM) 
is providing a fair account of the performance of downstream network 
pharmacies. Finally, CMS, as part of its administration of the Part D 
program, conducts audits of selected sponsors' Part D operations each 
year, including a review of the audit strategies sponsors have 
implemented to meet the compliance program requirement.
                       early childhood education
    Question. The fiscal year 2017 budget request, in line with the 
authorization included in the Every Student Succeeds Act (ESSA), 
proposes to transition funding for the Preschool Development Grants 
program from the Department of Education to the Department of Health 
and Human Services. Can you provide more detail as to how this 
transition will occur? How will the Department of Health and Human 
Services work with the Department of Education to support high-quality 
preschool programs?
    Answer. The Department of Health and Human Services (HHS) and 
Department of Education will continue to jointly administer the 
Preschool Development Grants program in 2017 and beyond HHS has worked 
closely with our colleagues at the Department of Education to ensure 
that our programs are coordinated, serve our Nation's children as best 
as possible, and create a continuum of high-quality early learning 
services beginning at birth and continuing through age five.
    The Departments have had success in the joint administration of 
Race to the Top-Early Learning Challenge and Preschool Development 
Grants in previous years and engage in numerous other activities to 
ensure coordination at all levels. For example, the Departments co-
chair an Interagency Policy Board on Early Learning, that coordinates 
policy, programs, research, and technical assistance across agencies 
and issues joint policy statements on key issues, including the 
inclusion of young children with disabilities in classrooms and 
programs with typically developing peers and preventing and eliminating 
the expulsion of young children from early childhood programs. Other 
examples of collaboration include the joint development of Birth to 
Five: Watch Me Thrive, which provides a toolkit to increase rates of 
developmental screening and follow-up and dissemination of materials 
highlighting how to utilize Medicaid to support creating school 
environments with physical and mental health supports.
    We appreciate the importance of close coordination in the joint 
administration of the Preschool Development Grants Program, and will 
continue to keep your staff updated as we proceed with planning and 
implementation.
    Question. The fiscal year 2017 budget requests $350,000,000 for 
Preschool Development Block Grants, including $100,000,000 for new 
awards. It is my understanding that these grants are intended to build 
State and local capacity to implement preschool for underserved 4-year 
olds. What steps does the Department plan to take to ensure that 
funding awarded through Preschool Development Block Grants is awarded 
to States where Federal support for early childhood education can meet 
the needs of rural, minority, and low-income students?
    Answer. The creation of the Preschool Development Grants program in 
2014, consistent with the President's Preschool for All mandatory 
proposal, provides funding to States to build and expand high-quality 
preschool for children from low- and moderate-income families in a 
mixed delivery system of providers. This mixed delivery includes 
schools, licensed child care centers, Head Start, or other community-
based organizations prepare low-income and disadvantaged children to 
enter kindergarten.
    The fiscal year 2017 request would allow HHS to work with the 
Department of Education to issue 18 continuation grants for the fourth 
and final year of the existing initiative, which enables existing 
Preschool Development Grant grantees to continue building and expanding 
preschool in their States. Working in over 200 high need communities, 
the current grantees have demonstrated tremendous success in building 
the fundamental components of a high quality preschool system and 
expanding high quality preschool models. For example, Arizona is 
providing early childhood mental health consultation and intervention 
as part of the comprehensive supports to Preschool Development Grant-
funded programs, which are located in high-need communities. The 
increase in 2017 will allow for new grants under the ESSA to improve 
the overall quality of preschool programs while improving coordination 
across early learning systems and increasing parent choice and 
knowledge about these programs.
    The PDG expansion is one of several efforts the Budget supports to 
expand access to high quality early learning to children in underserved 
communities. The fiscal year 2017 Budget also includes an increase of 
approximately $200 million for the Child Care and Development Block 
Grant (CCDBG), including $160 million to support implementation of the 
changes required by the recent bipartisan reauthorization and $40 
million to test innovative strategies to address the child care needs 
of working families, such as care during non-traditional hours and in 
rural areas. Increases are also requested in Head Start and Home 
Visiting.
                                 ______
                                 
             Questions Submitted by Senator Lamar Alexander
          interdepartmental review of early learning programs
    Question. On November 19, 2014, the President signed the Child Care 
and Development Block Grant Act into law. This law required the 
Secretary of Health and Human Services to conduct, within 1 year of 
enactment, an interdepartmental review of all early learning and care 
programs to identify overlapping programs and make recommendations to 
Congress for elimination and consolidation. We are nearly 3 months past 
the mandated deadline of this report. When does the Department plan to 
issue this report?
    Answer. The Departments are currently in the process of finalizing 
the joint report and are working to get the completed report to 
Congress. The Departments will provide the joint report to Congress as 
soon as the process is complete.
            child care and development block grant vouchers
    Question. The Child Care and Development Block Grant (CCDBG) Act 
stipulates that nothing shall ``favor or promote the use of grants and 
contracts for the receipt of child care services under this subchapter 
over the use of child care certificates.'' Report language reinforces 
Congressional intent that the primary goal of CCDBG is to promote 
parental choice through the use of vouchers. Any requirements through 
regulations to mandate States to use grants and contracts, in any 
capacity, interferes with a State's ability to maintain the use of 
vouchers. As your department continues to develop proposed regulations 
for the Child Care and Development block grant, how do you intend to 
maintain the use of vouchers, as well as State discretionary authority 
to decide how and when to use grants and contracts to deliver services?
    Answer. We agree that parental choice is important to the Child 
Care and Development Block Grant (CCDGB) program and the families it 
serves. Under the December 2015 Notice of Proposed Rulemaking, States 
must continue to offer every family receiving a subsidy the option to 
use a certificate/voucher. The proposal did not require the option of a 
grant- or contract-funded slot for every family, rather each State 
would determine the extent to which it will use grants and contracts. 
We believe that parents are in the best position to choose the care 
that best fits their families' needs. Child care certificates (or 
vouchers) are important because they give parents the opportunity to 
select from a range of child care options.
    Some communities lack an adequate supply of child care providers, 
particularly of high-quality providers, and particularly for certain 
types of care, such as infant and toddler care. A lack of supply limits 
parent choice because there are simply no quality providers from which 
to choose. For example, the National Survey of Early Care and Education 
found that while 89 percent of centers served 4-year old children, only 
36 percent of centers served babies less than a year old. Without an 
adequate supply of providers, a certificate or voucher is ineffective 
because a family cannot use it. The 2014 bipartisan reauthorization of 
the CCDBG Act recognized this problem by including important supply-
building provisions. Where States have used grants and contracts in a 
targeted manner, they have helped stabilize the supply and quality of 
care for specified populations of children.
    In our December 2015 Notice of Proposed Rulemaking, we proposed 
that every State make some use of grants and contracts, with the extent 
of use determined by the State, in order to address supply gaps for 
high-quality care in communities. We are currently reviewing public 
comments received in response to this proposal will give the comments 
careful consideration as we develop the final rule.
                  preschool development grants program
    Question. As part of the Every Student Succeeds Act, Congress 
authorized a new Preschool Development Grants program to be jointly 
administered by the Department of Health and Human Services and the 
Department of Education. How do you intend to preserve the 
Congressional intent outlined in the program purposes, which call for 
collaboration and coordination among existing programs and new 
partnerships in order to maximize parental choice in a mixed delivery 
system of early childhood education programs? How will you promote the 
continuation of coordination efforts past the initial planning year 
through the lifetime of the grant and beyond?
    Answer. Consistent with the statute, the purpose of the Preschool 
Development Grants program is to coordinate early childhood education 
programs in a mixed delivery system of providers including schools, 
licensed child care centers, Head Start, or other community-based 
organizations that will prepare low-income and disadvantaged children 
to enter kindergarten and to improve the participation of children in 
high-quality programs in this system. These goals are consistent with 
our efforts to align all early learning programs and ensure a continuum 
of services for children birth to school entry. We are working 
collaboratively with the Department of Education to ensure that the 
purposes as defined in the statute are clearly articulated and promote 
coordination beyond the initial planning year through the lifetime of 
the grant and beyond. Although we are early in the process, we are 
working to identify how these goals and principles will be articulated. 
Additionally, we are working to ensure that we remove any barriers for 
States to implement and provide services through a mixed-delivery 
system and through better alignment of policies and regulations that 
cross the departments and funding sources.
                           fda generic drugs
    Question. On November 13, 2013 the FDA released a proposed rule 
that would require generic drug manufacturers to make unilateral 
changes to the labels for generic drugs, even if the manufacturer of 
the corresponding brand name drug has not implemented the same labeling 
change. If finalized, this rule would impose new regulatory burdens and 
potentially expose generic drugmakers to significant new State law tort 
liability.
    The President's fiscal year 2017 budget request includes several 
proposals that, according to the Administration, would ``address the 
rising cost of pharmaceuticals.'' At the same time, the proposed 
generic labeling rule imposes significant new burdens that could be 
passed on to consumers in the form of higher drug prices. By some 
estimates, the rule could increase spending on generic drugs by as much 
as $4 billion, $1.5 billion of which would be borne by taxpayers 
through government healthcare spending. In contrast, the cost estimate 
in the proposed rule States that it is expected to generate little 
cost.
    Given the potential impact on consumers and taxpayers, it is 
critical that we have an accurate cost estimate. Please describe the 
process by which the Department of Health and Human Services analyzes 
the economic impact of new requirements, including a description of 
which factors are and are not considered as part of that analysis. 
Please also explain why the cost estimate included in the proposed 
generic labeling rule is billions of dollars less than other cost 
estimates, and describe whether and how the Department is considering 
revisions to its prior estimate.
    Answer. The proposed rule is intended to improve the communication 
of important drug safety information to healthcare professionals and 
patients. FDA has received a great deal of public input from 
stakeholders during the comment period on the proposed rule regarding 
the best way to accomplish this important public health objective.
    FDA is carefully considering comments submitted to the public 
docket established for the proposed rule from a diverse group of 
stakeholders including: consumers and consumer groups, academia 
(including economists), healthcare associations, drug and pharmacy 
associations, brand and generic drug companies, law firms, State 
governments, and Congress, including comments proposing alternative 
approaches to communicating newly acquired safety-related information 
in a multi-source environment (see Docket No. FDA-2013-N-0500). These 
comments include a summary of FDA's meeting with the Generic 
Pharmaceutical Association (GPhA) on September 8, 2014, to listen to 
their comments and views regarding the proposed rule. In addition, FDA 
held a public meeting on March 27, 2015, at which any stakeholder had 
the opportunity to present or comment on the proposed rule, or on any 
alternative proposals intended to improve communication of important, 
newly acquired drug safety information to healthcare professionals and 
the public. In the February 18, 2015, notice announcing the public 
meeting, FDA reopened the docket for the proposed rule until April 27, 
2015, to allow the submissions of written comments concerning proposals 
advanced during the public meeting. FDA will determine next steps based 
on our analysis of comments on the proposed rule and additional 
information submitted as part of the public meeting.
    Any final rule that is adopted will reflect FDA's consideration of 
public comments, including the varying perspectives related to the 
potential economic impact, and would be accompanied by an analysis of 
the economic impact of the regulatory change described in the final 
rule. This regulatory impact analysis would be based on the framework 
described in Executive Orders 12866 and 13563, and use the best 
available techniques to quantify anticipated present and future 
benefits and costs. The regulatory impact analysis would help ensure 
that any regulation is adopted only upon a reasoned determination that 
its benefits justify its costs, and is tailored to impose the least 
burden on society, consistent with obtaining regulatory objectives.
               fda budget authority for medical products
    Question. I am disappointed that the President's budget request for 
the Food and Drug Administration does not acknowledge the exciting time 
in science by requesting a meaningful increase in budget authority for 
medical products. An additional $25 million was requested this year 
after the $104 million in additional funds was provided to the agency 
last year for food safety activities, while an increase of only $3.196 
million was requested for medical product safety and availability. FDA 
involvement in patient focused drug development, next generation 
sequencing, and biomarkers is integral to Precision Medicine and the 
Cancer Moonshot Initiatives. Can you explain?
    Answer. The President's Budget requests $2.8 billion for Medical 
Product Safety, an increase of $116 million when accounting for all 
resources above fiscal year 2016 enacted levels, and includes $75 
million in new mandatory funding for the Vice President's Cancer 
Moonshot. Patient focused drug development, next generation sequencing, 
and biomarkers continue to be important priorities to FDA. The request 
considered various priorities when deciding on the requested increase 
for medical product safety and availability.
                                 ______
                                 
                Questions Submitted by Senator Mark Kirk
                         smart card technology
    Question. In several meetings, you and I have discussed the 
potential for smart card technology to reduce administrative 
procedures, eliminate fraudulent spending, and protect identity in 
healthcare spending, specifically in Medicare. You conveyed your 
support for broadly addressing this very issue across all agencies from 
your previous post at OMB. Recent GAO reports support the use of smart 
cards for identity protection and recovering improper payments.
    Please name which programs within HHS that would benefit from this 
technology and how they would benefit.
    Answer. MACRA directed HHS to review the cost effectiveness and 
technological viability of use electronic Medicare beneficiary and 
provider cards (such as cards that use smart card technology, including 
an embedded and secure integrated circuit chip), as presented in the 
Government Accountability Office report required by the conference 
report accompanying the Consolidated Appropriations Act, 2014 (Public 
Law 113--76). This work is currently underway. Given that analysis is 
still underway for Medicare, we have not at this time determined how 
this technology would be viable or benefit other HHS programs.
    Question. If a pilot program could be conducted to demonstrate the 
effectiveness of the smart card technology, what would the structure of 
the pilot look like?
    Answer. MACRA directed HHS to review the cost effectiveness and 
technological viability of using electronic Medicare beneficiary and 
provider cards (such as cards that use smart card technology, including 
an embedded and secure integrated circuit chip), as presented in the 
Government Accountability Office report required by the conference 
report accompanying the Consolidated Appropriations Act, 2014 (Public 
Law 113--76). This work is currently underway.
    In 2011 and 2012, CMS conducted a pilot program in which physicians 
and suppliers were issued electronically readable cards that they 
swiped when referring or fulfilling medical supply orders. When swiping 
the cards, they entered the last four digits of the beneficiary's 
Medicare number into credit card readers. CMS used information from the 
card transactions, including the date and beneficiary Medicare numbers, 
to match the transactions to submitted claims. The pilot only studied 
the ability to match card transactions with submitted claims, and did 
not involve any changes to claims processing systems or the 
adjudication process.\2\
---------------------------------------------------------------------------
    \2\ From March 2015 GAO report Potential Uses of Electronically 
Readable Cards for Beneficiaries and Providers.
---------------------------------------------------------------------------
    As a result of the pilot program, CMS found that many providers 
could not participate in the program because they did not have access 
to the necessary technology. Further, CMS was unable to assess any 
program integrity effect from use of the cards due to low provider 
participation in the pilot.
    Question. Specifically within the Centers for Medicare and Medicaid 
Services (CMS), could smart card technology reduce improper payments in 
outpatient billing in Medicare Parts A, B, C, or D?
    Answer. The GAO recently found that the use of smart cards could 
have affected about 22 percent (165 cases) of cases GAO reviewed in 
which the entire or part of the case could have been affected because 
they included schemes that involved the lack of verification of the 
beneficiary or provider at the point of care. However, in the majority 
of cases (78 percent), smart card use likely would not have affected 
the cases because either beneficiaries or providers were complicit in 
the schemes, or for other reasons. For example, the use of cards would 
not have affected cases in which the provider misrepresented the 
service (as in billing for services not medically necessary), or when 
the beneficiary and provider were not directly involved in the scheme 
(as in illegal marketing of prescription drugs).
    In these instances, the schemes would not have been affected by the 
smart cards because although the beneficiary and provider were present 
at the point of care, the provider misrepresented the services rendered 
after the smart cards would have registered their identities. These 
schemes included the following:
  --billing for services that were not provided along with services 
        that were provided legitimately,
  --billing for services that were not medically necessary,
  --upcoding,
  --unbundling of services,
  --billing for services that were not prescribed or not referred by a 
        physician, and
  --billing for services as if they were provided by a physician to 
        receive a higher payment rate when they were actually provided 
        by another provider in which the payment rate would have been 
        lower.
    In these schemes, smart cards would not be able to detect that the 
provider misrepresented the actual services provided even if the cards 
verified the beneficiary's and provider's presence. Similarly, schemes 
that involved a provider misrepresenting eligibility to provide 
services would not have been affected by smart cards, including schemes 
in which bills were submitted for services provided by an excluded 
provider or by an unlicensed, uncertified, or ineligible provider. Many 
of these schemes involved healthcare entities that billed for services 
provided by employees or contractors that were not licensed or were 
excluded from providing care.\3\
---------------------------------------------------------------------------
    \3\ From Jan 2016 GAO report Information on Most Common Schemes and 
the Likely Effect of Smart Cards.
---------------------------------------------------------------------------
    Medicare Advantage organizations and Prescription Drug Plan 
sponsors issue cards directly to their enrollees.
    Question. Similarly, could smart card technology reduce duplicative 
procedures and duplicative or fraudulent spending in Medicare Parts A 
and B combined?
    Answer. The GAO recently found that using electronically readable 
cards to authenticate beneficiary and provider presence at the point of 
care could potentially limit certain types of Medicare fraud. However, 
the GAO could not determine the extent to which authenticating 
beneficiaries and providers at the point of care could limit fraud 
because there is no reliable estimate of the extent or total dollar 
value associated with specific types of Medicare fraud schemes.
    According to the GAO, use of the cards would not prevent providers 
from mischaracterizing services, billing for medically unnecessary 
services, or adding a service that was not provided to a claim for 
otherwise legitimate services because such fraud does not involve 
issues related to authentication. Instead, these types of fraud 
typically involve providers that wrongly bill Medicare for the care 
provided, or misrepresent the level or nature of the care provided. The 
use of electronically readable beneficiary and provider cards would 
also have little effect on preventing fraud that involves collusion 
between providers and beneficiaries because complicit beneficiaries, 
including those who receive kickbacks, would likely allow their cards 
to be misused.\4\
---------------------------------------------------------------------------
    \4\ From Jan 2016 GAO report Information on Most Common Schemes and 
the Likely Effect of Smart Cards.
---------------------------------------------------------------------------
    Question. What about its effectiveness in Medicare Advantage?
    Answer. As noted above, Medicare Advantage organizations issue 
cards directly to their enrollees. The GAO has noted that Medicare 
beneficiaries who enroll in Part C or Part D plans receive separate 
cards from those plans, in addition to their traditional Medicare card.
    Question. Which parts of Medicare could CMS conduct a pilot in that 
includes insurers already utilizing smart card technology, thereby 
reducing burden on CMS?
    Answer. CMS regularly works in partnership with insurers and is 
frequently interested in exploring ways to work with the private sector 
to reduce waste, fraud and abuse. For example, the Healthcare Fraud 
Prevention Partnership (HFPP) is a voluntary public-private partnership 
between the Federal Government, State officials, law enforcement, 
private health insurance plans and associations, and healthcare anti-
fraud associations.
                                 ______
                                 
          Questions Submitted by Senator Shelley Moore Capito
                       fda labeling for anda rule
    Question. In 2013 the FDA released a proposed rule on labeling 
changes for ANDA holders. This proposed rule, titled Supplemental 
Applications Proposing Labeling Changes for Approved Drugs and 
Biological Products, Docket No. FDA-2013-N-0500, has not yet been 
finalized. Have you made a determination whether you are going to move 
forward with this rule?
    Answer. The proposed rule is intended to improve the communication 
of important drug safety information to healthcare professionals and 
patients. FDA has received a great deal of public input from 
stakeholders during the comment period on the proposed rule regarding 
the best way to accomplish this important public health objective.
    FDA is carefully considering comments submitted to the public 
docket established for the proposed rule from a diverse group of 
stakeholders including: consumers and consumer groups, academia 
(including economists), healthcare associations, drug and pharmacy 
associations, brand and generic drug companies, law firms, State 
governments, and Congress, including comments proposing alternative 
approaches to communicating newly acquired safety-related information 
in a multi-source environment (see Docket No. FDA-2013-N-0500). These 
comments include a summary of FDA's meeting with the Generic 
Pharmaceutical Association (GPhA) on September 8, 2014, to listen to 
their comments and views regarding the proposed rule. In addition, FDA 
held a public meeting on March 27, 2015, at which any stakeholder had 
the opportunity to present or comment on the proposed rule, or on any 
alternative proposals intended to improve communication of important, 
newly acquired drug safety information to healthcare professionals and 
the public. In the February 18, 2015, notice announcing the public 
meeting, FDA reopened the docket for the proposed rule until April 27, 
2015, to allow the submissions of written comments concerning proposals 
advanced during the public meeting. FDA will determine next steps based 
on our analysis of comments on the proposed rule and additional 
information submitted as part of the public meeting.
    The Unified Agenda, available at http://www.reginfo.gov/public/do/
eAgenda
ViewRule?pubId=201510&RIN=0910-AG94 currently lists an anticipated 
publication date of July 2016 for the final rule. The dates for rules 
in the Unified Agenda are projected dates that may be adjusted to 
reflect ongoing work on specific rules.
    Question. Is there evidence that the current reporting requirements 
are not being complied with by generic drug manufacturers or that they 
are inadequate?
    Answer. The proposed rule focuses on the obligation to update 
labeling to reflect newly acquired information, not on the legal duties 
to report adverse drug events to FDA or more generally to meet post-
market surveillance requirements associated with adverse event 
reporting obligations. The proposed rule neither cites nor is based on 
evidence that generic drug manufacturers are not submitting to FDA 
required reports of spontaneous adverse event reports that they 
receive.
    Question. Has the FDA estimated the impact the rule could have on 
prescription drug costs and access? If so, what is the impact?
    Answer. The proposed rule is intended to improve the communication 
of important drug safety information to healthcare professionals and 
patients. FDA has received a great deal of public input from 
stakeholders during the comment period on the proposed rule regarding 
the best way to accomplish this important public health objective.
    FDA is carefully considering comments submitted to the public 
docket established for the proposed rule from a diverse group of 
stakeholders including: consumers and consumer groups, academia 
(including economists), healthcare associations, drug and pharmacy 
associations, brand and generic drug companies, law firms, State 
governments, and Congress, including comments proposing alternative 
approaches to communicating newly acquired safety-related information 
in a multi-source environment. These comments include a summary of 
FDA's meeting with the Generic Pharmaceutical Association (GPhA) in 
September 2014, to listen to their comments and views regarding the 
proposed rule. In addition, FDA held a public meeting in March 2015, at 
which any stakeholder had the opportunity to present or comment on the 
proposed rule, or on any alternative proposals intended to improve 
communication of important, newly acquired drug safety information to 
healthcare professionals and the public. In the February 18, 2015 
notice announcing the public meeting, FDA reopened the docket for the 
proposed rule until April 27, 2015, to allow the submissions of written 
comments concerning proposals advanced during the public meeting. FDA 
will determine next steps based on our analysis of comments on the 
proposed rule and additional information submitted as part of the 
public meeting.
    Any final rule that is adopted will reflect FDA's consideration of 
public comments and would be accompanied by an analysis of the economic 
impact of the regulatory change described in the final rule. This 
regulatory impact analysis would be based on the framework described in 
Executive Orders 12866 and 13563, and use the best available techniques 
to quantify anticipated present and future benefits and costs. The 
regulatory impact analysis would help ensure that any regulation is 
adopted only upon a reasoned determination that its benefits justify 
its costs, and is tailored to impose the least burden on society, 
consistent with obtaining regulatory objectives.
                                 ______
                                 
                Questions Submitted by Senator Jack Reed
                             liheap program
    Question. Access to affordable home energy is a matter of health 
and safety for many low-income households, children, and seniors. 
Unfortunately, the average LIHEAP grant has declined over the last few 
years and now covers just a fraction of average home energy costs, 
leaving many low-income families and seniors with fewer resources 
available to meet other basic needs. There remains a significant gap 
between the need and the funding.
    What are the reasons why LIHEAP doesn't rate more highly among HHS 
priorities? How will HHS continue its commitment to providing our most 
vulnerable populations with vital home energy assistance?
    Answer. The budget proposes to fund LIHEAP through a combination of 
discretionary funds ($3 billion) and a proposed mandatory funding 
trigger providing additional resources in response to energy price 
spikes, increases in eligibility, and extreme cold at the beginning of 
winter ($769 million based on a probabilistic score). Total resources 
of $3.8 billion are requested, an increase of $379 million over fiscal 
year 2016.
    Question. Congress provided $3.39 billion for LIHEAP; however, only 
$3.02 billion has been released to date. This means approximately $372 
million has not yet been released for its intended purpose, to provide 
home energy assistance to the most vulnerable households in the 
country.
    What is the Department's plan for these funds? When can we expect 
to see the $372 million released to States under the LIHEAP formula?
    Answer. HHS expects to make another release of LIHEAP funding in 
the near future. We will keep your staff updated as that occurs.
          cdc healthy homes lead poisoning prevention program
    Question. As you know, I have been advocating for the full 
restoration of CDC's healthy homes/lead poisoning prevention program 
for many years. Almost 5 years ago, this program was nearly eliminated 
and since then I have been working with my colleagues to restore the 
funding. Given the situation in Flint, Michigan, I was disappointed 
that the President's budget request only flat funded the CDC program, 
given the considerable need. It seems to me that this is one program we 
would want to increase this year.
    How will we be able to effectively prevent situations like Flint if 
some States still don't have lead poisoning prevention programs?
    Answer. The recent events in Flint have highlighted the continued 
risk that lead poisoning presents to communities and children. CDC 
currently funds 29 States, Washington D.C., and five other cities 
through a lead poisoning prevention cooperative agreement. The 
cooperative agreement focuses on reducing children's blood lead levels 
through surveillance and primary prevention. These awards support 
grantees to:
  --Implement and/or improve lead surveillance systems and data 
        collection; and
  --Increase the use of surveillance data to guide population-based 
        prevention strategies (e.g., housing rehabilitation, 
        enforcement of housing and health codes, and early childhood 
        and other educational activities).
    These surveillance data can help grantees and other partners target 
testing and resources to the highest-risk children as well as identify 
and address emerging sources of exposure.
    However, most unfunded States are unable to collect lead 
surveillance data and/or report it to CDC. Without such data, States 
and cities are unable to target resources towards those with the 
greatest need or identify and address areas of concern. We would like 
to work with Congress to help ensure that States have the support 
needed to prevent lead poisoning.
    Regarding the Flint water crisis specifically, the Federal response 
in place is supporting State and local leaders identify the size and 
scope of the problem, and to make and execute a plan for mitigation of 
the short- and long-term health effects of lead exposure. Specific 
activities include:
  --HHS has deployed a total of 24 Commissioned Corps officers in 
        support of eight distinct mission elements of the Public Health 
        Assistance and Support Team, including mental health support, 
        psychological first aid training focusing on schools and faith 
        entities, and behavioral health support for community-based 
        health and human services providers.
  --On March 3, the Centers for Medicare & Medicaid Services (CMS) 
        approved the State of Michigan's 1115 demonstration to extend 
        Medicaid coverage and services to Flint, Michigan residents 
        impacted by the lead exposure. Approximately 15,000 additional 
        children and pregnant women will be eligible for Medicaid 
        coverage and 30,000 current Medicaid beneficiaries in the area 
        will be eligible for expanded services under this new waiver 
        agreement. Additionally, we are working with the State to 
        design and expeditiously process an alternative option through 
        a targeted and time-limited health services initiative under 
        title XXI of the Social Security Act for abatement activities 
        that would complement other State and local efforts to remove 
        lead hazards from the homes of Medicaid and CHIP eligible 
        children and pregnant women.
  --HHS awarded $500,000 in emergency supplemental funding to Hamilton 
        Community Health Network, Inc. and Genesee Health System, 
        Health Resources and Services Administration (HRSA)-funded 
        health centers, to hire additional personnel and provide more 
        lead testing, treatment, outreach, and education to meet the 
        increased need for health services in the Flint community.
  --ASPR is using existing resources to help State health officials 
        identify vulnerable populations in Flint who may need further 
        targeted outreach and assistance.
  --The Administration for Children and Families (ACF) and HRSA 
        continue working with their grantees in the area to disseminate 
        public health education through Head Start, Community Health 
        Centers, and other programs to help families understand the 
        risks of lead in the water. ACF and HRSA are working to 
        leverage Medicaid to ensure that children and pregnant women 
        have access to services to assist in treating exposure to lead.
  --The Disaster Distress Helpline, sponsored by the Substance Abuse 
        and Mental Health Services Administration (SAMHSA), is 
        available to provide crisis counseling and support to people--
        including children and families in Flint--who are experiencing 
        emotional distress related to natural or human-caused 
        disasters.
  --The Centers for Disease Control and Prevention (CDC)'s Agency for 
        Toxic Substances and Disease Registry (ATSDR) is providing 
        technical assistance to the State on lead exposure, water 
        sampling protocols, and home inspections. ATSDR is working with 
        the State to determine the number of children exposed to lead 
        in Flint to ensure that children who should be screened are 
        getting screened. After a formal request from the State to 
        investigate rashes and other skin concerns affecting Flint 
        residents, a team of experts from CDC and ATSDR began an 
        Assessment of Chemical Exposure investigation on February 22.
  --The Food and Drug Administration (FDA)'s Detroit District Office 
        assessed potential impacts on FDA-regulated industries in the 
        Flint area, including human food and animal feed production. No 
        impacts were found, and FDA continues to assess and monitor the 
        situation.
  --The National Institutes of Health (NIH)/National Institute of 
        Environmental Health Sciences (NIEHS) has an expedited process 
        for reviewing research proposals and funding grants to address 
        environmental emergencies, such as the lead-contaminated water 
        crisis in Flint. The NIEHS is soliciting these research 
        proposals now. Additionally, the new NIH Disaster Research 
        Response initiative is working to improve research tools, 
        protocols, and training necessary to conduct time-critical 
        health research in response to disasters, which can be found at 
        http://dr2.nlm.nih.gov/.
                           access to naloxone
    Question. While the Senate recently passed legislation to help 
prevent drug overdoses and expand access to treatment, more needs to be 
done, particularly to ensure new funding is made available immediately 
for these efforts. I have introduced legislation to provide communities 
access to naloxone--the overdose reversal drug--to prevent deaths and 
help move people into treatment options.
    What is HHS doing to expand access to naloxone and to help prevent 
overdose deaths?
    Answer. In March 2015, I announced the Department's plan for 
combatting opioid misuse, abuse, and overdose deaths, which includes a 
set of targeted strategies focused on stemming the rise in opioid-
related mortality and morbidity. One of the three priority areas of my 
plan is promoting the use of naloxone.
    I am grateful for the $12 million the Congress provided in fiscal 
year 2016 for the Substance Abuse and Mental Health Services 
Administration for grants to States to purchase naloxone, equip first 
responders in high-risk communities, and provide education and other 
materials to assemble and disseminate overdose kits. This funding and 
training support aims to allow States to target resources where it is 
most needed in their communities. The fiscal year 2017 President's 
Budget includes $12 million, the same level as fiscal year 2016, to 
continue support for this critical activity.
    I also thank you for the $1.8 million the Congress provided in 
fiscal year 2015 to support rural communities in reducing morbidity and 
mortality related to opioid overdoses through the Health Resources and 
Services Administration's Rural Opioid Overdose Reversal Grant Program. 
These awards were announced on September 17, 2015 to purchase naloxone, 
and training for its use by licensed healthcare professionals and 
emergency responders in rural areas. The fiscal year 2017 President's 
Budget requests an additional $10 million to support these activities, 
increasing the number of rural communities that will be served, and 
placing a stronger emphasis on prevention, education, referral and 
treatment.
    Further, HHS also continues to make progress in several other areas 
that will promote the use of naloxone. This past July, the Food and 
Drug Administration, in collaboration with other HHS agency partners, 
held a scientific workshop to initiate a public discussion about issues 
surrounding the uptake of naloxone in a variety of medical and non-
medical settings to reduce the incidence of opioid overdose fatalities. 
FDA continues to make naloxone a priority, having approved, on an 
expedited timeframe, both an auto-injector and an intranasal 
formulation. Both of these products are designed for use by lay 
bystanders, as well as first responders. FDA continues to explore 
alternative methods for making naloxone more available.
    HHS has also held two national meetings since 2014 where States 
were able to collaborate with one another to develop and share best 
practices for interventions to address the opioid epidemic, including 
those related to naloxone dissemination and utilization.
                                 ______
                                 
             Questions Submitted by Senator Jeanne Shaheen
                           zika supplemental
    Question. Unfortunately, New Hampshire had the State's first 
confirmed case of Zika this week. An adult female contracted the virus 
after sexual contact with a male who was symptomatic and had traveled 
to a country where Zika virus transmission is occurring. Thankfully, 
the patient has fully recovered and is not pregnant.
    I know that the Administration is seeking a $1.9 billion Zika 
supplemental to combat the spread of Zika.
    What funding sources does HHS currently have to work immediately on 
the Zika issue while we deliberate the supplemental funding?
    Answer. HHS is supporting Zika efforts through reprioritization of 
existing funding resources, including reprogramming fiscal year 2016 
funding for CDC's Public Health Emergency Preparedness program, 
transfer from CDC's fiscal year 2016 funding for the Strategic National 
Stockpile, and repurposing of prior-year balances from the Prevention 
and Public Health Fund. This funding will enable HHS to respond to 
urgent needs in the short-term; however this funding approach will not 
be sustainable and emergency funding, as requested, will be necessary 
for an effective response. To minimize the impact of the reallocations 
noted above, the Administration's emergency supplemental appropriations 
request includes a provision which would allow funds to reimburse HHS 
accounts for activities supporting Zika disease response that occurred 
prior to enactment. This authority is critical to maintain our 
preparedness and response capabilities.
    Question. What funds are available to help States address Zika, 
particularly to help with State public health laboratory testing 
capabilities and protocols?
    Answer. CDC is working with health departments across the country 
to ensure coordination and to expand capacity for detecting and 
responding to Zika virus. Surveillance is essential to monitor and 
quickly identify areas with mosquito-borne (local) Zika transmission. 
This includes multi-faceted surveillance for arboviruses, including 
Zika, through ArboNET, an integrated network which funds staff in 49 
States, Puerto Rico, and six large municipalities to conduct human case 
investigations, collect and test mosquitos, and perform laboratory 
analysis on arboviruses including Zika. Zika virus is now a nationally 
notifiable disease, meaning States report the virus to CDC, which will 
aid Zika surveillance efforts. CDC is also working with several States 
and Puerto Rico to determine a baseline prevalence of microcephaly so 
that any increase, should it occur, can be quickly and accurately 
identified.
    Additional funding, as requested in the Administration's emergency 
supplemental appropriations request, will be essential to supporting 
CDC's expansion of efforts to provide financial and technical resources 
to States and territories to strengthen their capacity to prepare for 
and respond to emerging insect-borne threats such as Zika virus. These 
resources will be used to help health departments expand their 
capability to manage cases of local Zika virus transmission in their 
areas and to implement community education and prevention programs to 
reduce human-mosquito contact and subsequently, the risk of Zika 
transmission. Resources will also be used to implement mosquito control 
strategies, including mosquito surveillance. Current mosquito 
surveillance capacity is uneven across the country, which makes our 
knowledge about the locations of the two mosquito vectors that transmit 
Zika virus potentially incomplete. To effectively track the spread of 
the outbreak, it is critical that States and territories receive 
specimens and test for Zika virus to diagnose and report travel-related 
and locally acquired cases of Zika. Under the supplemental request CDC 
will expand its efforts to assist public health labs nationwide with 
the tools necessary to test for Zika and to provide guidance on how to 
interpret test results.
    CDC is also currently distributing testing kits so that more health 
departments have the proficiency to perform testing, but will need to 
increase the existing capacity to meet the projected demand for Zika 
testing. Given that, last year, it is estimated that over 500,000 
travelers to areas of current Zika transmission were pregnant women and 
36,000 pregnant women are currently living in Puerto Rico, the 
expansion of testing capacity in public health labs nationwide, 
included in the request, is urgently needed in order to ensure that 
every pregnant woman needing testing for Zika virus has access.
    Question. How are you coordinating with other agencies working on 
Zika, and with other countries who are experiencing an outbreak?
    Answer. CDC is working in collaboration with other components of 
the Department of Health and Human Services (HHS), including the Office 
of the Assistant Secretary for Preparedness and Response (ASPR) and the 
Biomedical Advanced Research and Development Authority (BARDA), the 
National Institutes of Health, and the Food and Drug Administration. In 
addition, HHS is working with partners across the U.S. Government to 
communicate with travelers and healthcare providers; update travel 
alerts and clinical guidance; and develop improved mosquito-control 
methods.
    Through the Office of Global Affairs and CDC, HHS is also 
coordinating its response with the Pan American Health Organization 
(PAHO), the regional body of the World Health Organization (WHO), with 
other parts of WHO, and is collaborating with many international 
partners to learn more about this outbreak. ASPR and OGA also lead our 
efforts with the Global Health Security Initiative, a partnership with 
Canada, France, Germany, Italy, Japan, Mexico, the United Kingdom, the 
United States and the European Commission. CDC is also working with the 
Brazilian Ministry of Health on investigation and research 
partnerships. Research teams from CDC are also in other countries, 
including Colombia, to explore collaborations that will shed light on 
the risk of microcephaly in relation to Zika virus infection during 
pregnancy.
    In addition, CDC is offering support to all countries so that they 
can test samples from microcephaly cases for serologic evidence of Zika 
virus infection, and CDC is helping countries throughout the Americas 
establish in-country diagnostic capacity. To that end, we are 
currently, in conjunction with the PAHO, providing training to 
laboratorians in South and Central America on diagnostic tests, 
including two recent workshops in Brazil and Nicaragua.
    CDC's Central American office has also facilitated the verification 
of Zika cases in several countries throughout Latin America, including 
Colombia, Venezuela, and Nicaragua. At the request of the Department of 
State's Bureau of Medical Services, staff from CDC's Global Disease 
Detection Center in Guatemala has been involved in communication 
efforts to ensure that new information regarding Zika virus and its 
possible link to birth defects is communicated to U.S. Mission Health 
Unit staff throughout the Americas.
    Question. Could you specifically speak to family planning accounts 
included in the budget and the important role they play in the life of 
women and families, particularly as we face a potential Zika outbreak?
    Answer. The Title X family planning program is developing 
information resources for providers to use when educating clients and 
providing client-centered counseling. This includes hosting a webinar 
for providers and ensuring that providers have access to the full range 
of FDA-approved contraceptives, particularly long acting reversible 
contraceptives which can be offered to clients. Additionally, all CDC 
guidance is made available to grantees via a program listserv which is 
disseminated weekly or as needed for urgent information updates.
    The fiscal year 2017 request for family planning is $300 million 
and will expand family planning services to low income individuals by 
improving access to family planning centers and preventive services. 
The request is expected to support family planning services for 
approximately 4.3 million persons, with approximately 90 percent having 
family incomes at or below 200 percent of the Federal poverty level.
    Given our goal of preventing the risk of Zika virus to pregnant 
women, and women of childbearing age, we continue to support expanding 
access to preventive services such as contraception, and will closely 
monitor whether demand exceeds current funding in the context of our 
Zika response.
                   fiscal year 2017 opioid initiative
    Question. As you know, I believe that the opioid abuse and heroin 
epidemic is a public health emergency. I appreciate the efforts that 
the administration has made, but I do not think it is enough. In New 
Hampshire, we are losing a person a day, and nationwide each day 120 
people die from an overdose. More needs to be done.
    Everyone I meet with in New Hampshire tells me more resources are 
needed for law enforcement, prevention, intervention, recovery and 
treatment. We have chronically underfunded these accounts--and in fact 
$483 million dollars would need to be appropriated in fiscal year 2017 
to bring the SAMHSA prevention and treatment block grant back to fiscal 
year 2006 levels. I am disappointed that an emergency supplemental 
funding amendment to provide immediate funds to the States to address 
the crisis failed yesterday.
    Your budget addresses the drug abuse epidemic by providing $1.1 
billion in discretionary and mandatory funding.
    How will these funds will get to the healthcare providers and 
treatment and prevention professionals at the front lines?
    What in your proposal will assist those in recovery?
    How will you better coordinate your agencies resources at the State 
level and front lines of the crisis?
    Answer. Thank you for your continued support and leadership on this 
issue. The President's $1 billion opioids investment will expand the 
availability of opioid use disorder services by expanding access to 
treatment, reducing the cost of treatment, and engaging patients in 
treatment. Specifically, this new investment includes $920 million for 
new cooperative agreements to expand access to treatment services 
across the Nation. These funds will target areas of highest need and 
allow States to implement evidence-based strategies that help 
individual seek treatment, successfully complete treatment, and sustain 
recovery. These funds will meet local treatment needs like medication-
assisted treatment. States may also use these funds to further promote 
access to treatment services by expanding the availability of substance 
use disorder treatment providers and increasing use of health 
information technology. Eligible activities could also include care 
transition and care coordination services for those in recovery.
    The fiscal year 2017 President's Budget also includes $50 million 
for the National Health Service Corps to support additional behavioral 
health providers, including those with medication-assisted treatment 
training, in communities with healthcare provider shortages, and $30 
million for cohort monitoring and evaluation, to understand what works 
best and disseminate that knowledge.
    Coordination among Federal agencies and with our State and local 
partners has been a centerpiece of my strategy for combatting opioid 
misuse, abuse, and overdose, and is reflected in the investments 
proposed in the fiscal year 2017 President's Budget. This coordination 
begins within the Department. Senior staff led by the Office of the 
Assistant Secretary for Planning and Evaluation work assiduously to 
ensure that efforts at all stages from new research to developing new 
treatments to making grant awards and releasing prescribing guidelines 
are coordinated and leverage the expertise of the whole Department.
    In addition, we are coordinating this work with Federal agency 
partners through the Interagency Workgroup on Prescription Drug Abuse 
Prevention/Opioid Overdose Prevention, led by the White House's Office 
of National Drug Control Policy. One example of the Federal 
coordination taking place at this level is the $10 million fiscal year 
2017 President's Budget proposal to partner with the Department of 
Justice to implement a new Buprenorphine-Prescribing Authority 
demonstration to expand the types of providers who can prescribe 
Medication-Assisted Treatment.
    Coordination also continues between HHS and the States. For 
example, since 2014, HHS has held two 50-State meetings on the topic of 
opioids and has worked to engage our State and regional partners, 
including the National Governors Association, the Association of State 
and Territorial Health Officials, and the National Association of State 
Alcohol and Drug Abuse Directors in a variety of ways to advance 
efforts to prevent opioid use disorder and overdose death and to 
identify how best we can leverage our collective resources to bring us 
closer to ending this epidemic.
hospital consumer assessment of healthcare providers and systems survey
    Question. I recently joined Senator Collins in a letter to you with 
concerns about quality metrics, pain management and the move to value 
based purchasing.
    As you know, as CMS implements the Hospital Value-Based Purchasing 
Program, part of the payments will be based on performance of quality 
measures, based on patient feedback gleaned from the Hospital Consumer 
Assessment of Health Care Providers and Systems, or HCAHPS survey.
    I am concerned that the survey questions on pain management may not 
be adequate and may serve as an incentive for healthcare providers to 
over prescribe.
    What is CMS doing to address the inadequate survey questions and 
quality metrics related to opioid prescription and what more needs to 
be done to enhance provider education on pain management?
    Answer. HHS and the Centers for Medicare & Medicaid Services (CMS) 
share your concern about the misuse of prescription pain medications, 
especially opioids, and how survey questions, including those used on 
the Hospital Consumer Assessment of Healthcare Providers and Systems 
(HCAHPS) Survey, may affect pain management practices and opioid 
prescribing. Last fall, the Administration announced that it will 
undertake a review of how pain management is evaluated by patient 
experience surveys used by hospitals and other healthcare providers, 
including a review of how the questions these surveys use to assess 
pain management may relate to pain management practices and opioid 
prescribing. We typically test our survey questions on beneficiaries 
but we are also committed to consulting with physicians and hospital 
administrators as we explore possible changes to the survey. We look 
forward to updating you and other interested Senators when this work is 
completed. CMS has also launched several educational activities, 
including a national webinar in January, which will clarify the proper 
use of the HCAHPS Survey and its role in hospital payment, as well as 
call attention to revised instructions for proper opioid prescription 
practices.
    early intervention for misuse and abuse of prescription opioids
    Question. The misuse and abuse of prescription opioids and of 
illicit drugs has become a true public health crisis, with overdose 
deaths quadrupling since 1999. One area that often gets lost in this 
debate is primary prevention. This is a critical part of our efforts to 
address opioid abuse--stopping it before it starts. Research supported 
by the National Institute on Drug Abuse, Substance Abuse and Mental 
Health Services Administration and the Centers for Disease Control has 
found that early intervention, during pre-school or elementary school 
before problems emerge, can reduce risky behaviors during the teen 
years. These interventions will not only help reduce substance misuse, 
they will also improve academic performance and reduce bullying, 
depression, violence, suicide, unsafe sexual behavior and other 
problems.
    There is 40 years of research behind a prevention first approach 
and there are models underway right now that are working, but most 
prevention strategies are not in widespread use. My questions are:
    The Institute of Medicine has called for 10 percent of public funds 
spent on young people to be directed toward effective prevention 
interventions that promote healthy behaviors. Can you tell us what 
percentage of the President's opioids initiative would be directed 
toward prevention? Or what percentage from the overall HHS budget?
    Can you tell us how you plan to incorporate primary prevention into 
HHS' work addressing the opioid epidemic? How can we help communities 
to implement these interventions?
    There are multiple grant programs addressing prevention at the 
Department of Education, HHS and Justice. How is HHS coordinating with 
those departments to leverage resources?
    Answer. Again, thank you for your continued support and leadership 
on this issue. We know that preventing substance use during youth is a 
key factor in preventing future substance use, especially problematic 
substance use in adulthood. As noted, several NIDA-funded studies have 
found that universal, evidence-based prevention programs targeting 
youth such as the Iowa Strengthening Families Program can reduce future 
nonmedical use of prescription opioids in high school and early 
adulthood.
    In general, youth are doing the better than other age groups with 
respect to opioids. Rates of nonmedical use of prescription opioids 
among people 12-17 years old have been declining since 2002. In 2002, 
7.6 percent of individuals 12-17 years old reported nonmedical use of 
prescription opioids in the past year compared to 4.7 percent in 2014. 
Similarly, opioid-related mortality rates have also remained stable 
among 12-17 years since 2002.
    It is critical that we focus our resources on where we can have the 
greatest impact. As you know, my plan for combatting opioid misuse, 
abuse, and overdose is a coordinated, multi-faceted initiative that 
relies on education, prevention, and treatment strategies with the 
strongest evidence base, and the Department has been working diligently 
to develop and implement these strategies. The Department also agrees 
that prevention services are critical in addressing the opioid epidemic 
across the country. In addition to continuing support for ongoing work 
associated with Substance Abuse Prevention through SAMHSA's 20 percent 
set-aside for prevention within the Substance Abuse Prevention and 
Treatment Block Grant and their Strategic Prevention Framework, the 
fiscal year 2017 Budget includes improvements to prescribing practices 
as a key area where we can focus our efforts to prevent opioid misuse. 
While actions to address prescription opioid abuse must target both 
prescribers and high-risk patients, prescribers are the gatekeepers for 
preventing inappropriate access. Therefore, HHS is focused on 
increasing investments in State-based prescription drug monitoring 
programs and adoption of e-prescribing practices, disseminating 
guidelines for opioid prescribing, and training providers.
    The fiscal year 2017 President's Budget proposes a $13 million 
increase for Prescription Drug Overdose and Misuse Prevention, for a 
total of $80 million in discretionary resources, to support improved 
uptake of CDC's new ``Guideline for Prescribing Opioids for Chronic 
Pain'' among providers, and to provide ongoing support to all 50 States 
and D.C. through the Prescription Drug Overdose Prevention to States 
program. In addition, the budget proposes $5 million in new 
discretionary funding for the Office of the National Coordinator for 
Health Information Technology to harmonize technical standards in 
support of Prescription Drug Monitoring Programs, improve clinical 
decisionmaking, and further the adoption of electronic prescribing of 
controlled substances. In addition, the SAMHSA State Targeted Response 
Cooperative Agreement program, a $920 million effort, will enable 
States to identify primary prevention needs in their States. The 
program is designed to enable States to develop holistic approaches to 
addressing the opioid crisis.
    We must work across HHS, with our partner agencies and other 
stakeholders, as well as with Congress to identify and dismantle 
barriers as well as leverage our resources in order to effectively 
implement these strategies. Coordination of HHS activities addressing 
opioid use disorders is being led by the Office of the Assistant 
Secretary for Planning and Evaluation. In addition, HHS continues to 
coordinate its efforts to address opioid addiction and overdose with 
its Federal agency partners through the Interagency Workgroup on 
Prescription Drug Abuse Prevention/Opioid Overdose Prevention led by 
the Office of National Drug Control Policy. One example of the Federal 
coordination taking place at this level is the $10 million fiscal year 
2017 President's Budget proposal to partner with the Department of 
Justice to implement a new Buprenorphine-Prescribing Authority 
demonstration to expand the types of providers who can prescribe 
Medication-Assisted Treatment.
                                 ______
                                 
              Question Submitted by Senator Tammy Baldwin
                         national pain strategy
    Question. Secretary Burwell, it has been 9 months since HHS closed 
the public comment period for the draft version of the National Pain 
Strategy (NPS). The NPS was developed by four of HHS' agencies, in 
collaboration with the Department of Defense and the Department of 
Veterans Affairs, and is intended to provide a comprehensive, 
population health-level strategy for pain prevention, treatment, 
management, education, reimbursement, and research. In light of the 
Nation's opioid crisis, it is critical that the NPS is released and 
implemented in an effort to improve pain care with alternatives to 
addictive medications. I understand that a final version of the NPS is 
awaiting your approval.
    Do you have a release date for the NPS? What plans does HHS have in 
place to implement the NPS objectives?
    Answer. The National Pain Strategy was posted for a public comment 
period in April 2015, which generated a robust response. The comments 
were carefully considered and incorporated into the report, creating a 
stronger plan to improve pain care. Following that important, but time 
consuming step, all Department of Health and Human Services (HHS) 
agencies, the Department of Defense, and the Veterans Health 
Administration, which were involved in its development, carefully 
reviewed and revised the report. HHS expects to release the report in 
March 2016. Broad ranging efforts across the Government and with 
private partners will be needed to implement the objectives of the 
National Pain Strategy. The Office of the Assistant Secretary for 
Health, in conjunction with HHS operating and staff divisions, will 
develop a detailed implementation and evaluation plan after the release 
of the Strategy.

                          SUBCOMMITTEE RECESS

    Senator Blunt. And the subcommittee will stand in recess 
until 10 a.m. on Thursday, March 10.
    Thanks for being here, Secretary.
    [Whereupon, at 11:48 a.m., Thursday, March 3, the 
subcommittee was recessed, to reconvene at 10 a.m., Thursday, 
March 10.]