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[Senate Hearing 114-476]
[From the U.S. Government Publishing Office]

 
  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2016

                              ----------                              

                        THURSDAY, APRIL 23, 2015

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

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                        Office of the Secretary

STATEMENT OF HON. SYLVIA M. BURWELL, SECRETARY

                 OPENING STATEMENT OF SENATOR ROY BLUNT

    Senator Blunt. The Appropriations Subcommittee on Labor, 
Health and Human Services, and Education, and Related Agencies 
will come to order. We are certainly pleased to have the 
Secretary with us today.
    Secretary Burwell, thank you for taking your time to be 
here. One of my concerns that we have already talked about is 
finding out what spending number we actually have to work with 
and how we can work within the proposal that we have from the 
department, which is substantially higher than last year's 
level. I hope we can find common ground, so that we can really 
prioritize the concerns that we share with you and get the 
information, and understand where we need more information to 
figure out why we need to look at this a different way, when we 
need to look at this a different way.
    The bill that the Congress has passed on the SGR I think 
gives you some ongoing capacity to look at how doctors deliver 
care in different ways, certainly the community health center 
element of that bill, the ability to fund the shortfall, and 
where the health centers would have been and where they have 
been for the last 5 years, was a significant part of that bill.
    There are 23 million patients in 9,000 communities that are 
now served by those community health centers. The $150 per 
encounter cost is obviously a whole lot less than many of the 
alternatives, particularly the emergency room as an 
alternative. And this committee and the Senate generally have 
been very supportive of the community health center concept, 
and we look forward to you continuing to work with us and us 
working with you to be sure we are fully taking advantage of 
that.
    Last year, the Congress overwhelmingly passed 
reauthorization of the Child Care and Development Block Grant 
to improve health and safety standards and overall quality of 
childcare programs.
    This is another area where the Congress has spoken. We look 
forward to working with you to see what we can do to meet the 
goals in that.
    And finally, as we continue to work with the limited 
resources we are likely to have, funding should be targeting 
programs that have shown proven and effective results or 
programs that we all become convinced have that effective 
result potential out there. I am pleased that the department 
has requested a billion-dollar increase for NIH, the focal 
point of our Nation's medical research capacity.
    One of the things that happened when I was in the House was 
a doubling of that funding, but then once we got to the 
doubling goal, that seemed to be the place to stop. I know that 
Dr. Collins and you and me and others don't want that same 
experience to repeat itself, that we set a worthy goal but 
don't understand the importance of having that goal extend 
beyond achieving the first marker in the goal. So we will 
continue to work with you and NIH on that as well.
    I am pleased to be working on all these issues with Senator 
Murray. We are also lucky on this committee to have Senator 
Mikulski, the vice chairman of the committee, Senator Cochran 
the committee chairman often attends, as does Senator 
Alexander, the chairman of the authorizing committee. So a lot 
of people here very interested in what you are doing and 
appreciative of the work you have done in the time you have 
already been there.
    So, Senator Murray.

                   STATEMENT OF SENATOR PATTY MURRAY

    Senator Murray. Mr. Chairman, thank you very much. Good to 
be here with you again.
    I am really pleased to welcome Secretary Burwell today to 
discuss the fiscal year 2016 budget request for the Department 
of Health and Human Services. I really want to thank you for 
all you do to improve health and well-being for our families 
and communities across the country.
    There is really no question that when it comes to 
healthcare, we have taken historic steps forward in the last 
few years. As a result of the Affordable Care Act, more 
families are getting the quality, affordable coverage they 
need.
    But the work didn't end with the law that was passed. Far 
from it. I am focusing on continuing to build on the progress 
made so far, to make sure we do keep moving forward with more 
coverage, not less, more affordability, not less, and more 
quality, not less.
    Secretary Burwell, I know that continuing to make our 
healthcare system work better for families is a top priority 
for you as well. The role of your department is, of course, 
absolutely essential in this effort. The programs administered 
by the department impact families in a lot of important ways, 
from supporting biomedical research, to fighting public health 
threats, to expanding access to quality healthcare coverage for 
millions of workers and their families. Each of these 
investments and others is necessary if we want to improve our 
healthcare system and ensure that it puts patients first.
    So I am disappointed that the budget resolution passed in 
the House and Senate really double down on the harmful 
sequestration cuts that are set to kick back in now.
    Last Congress, as you know, I was very proud to work with 
Democrats and Republicans to break through the gridlock and 
dysfunction and reach an agreement that rolled back those 
harmful automatic sequestration cuts for 2 years, 2014 and 
2015. And I really believe we have to build on that agreement 
now and lift the caps, so we can invest responsibly in areas 
that are so important to our country's health, education, jobs, 
and defense.
    The President's budget, I was very pleased to see, does 
exactly that. It rolls back the unsustainable cuts to both 
defense and nondefense discretionary spending and is, 
therefore, able to support critical efforts to help our 
families and communities stay healthy.
    The department's budget request for programs within this 
subcommittee's jurisdiction totals $76 billion. That is an 
increase of $4 billion, or 6 percent over last year. It 
proposes additional sensible investments in biomedical 
research, in public health, in programs that provide access to 
affordable healthcare as well as learning programs and 
affordable childcare for working programs.
    I am looking forward to learning about many elements of the 
department's budget request in this hearing today. These 
include an increase of $1 billion for NIH, which would support 
a new precision medicine initiative and help maintain our 
country's leadership in biomedical innovation.
    And there are other investments proposed in the 
department's budget that are also important to strengthening 
our economy now and over the long term.
    I was really pleased that the budget includes a $1.5 
billion increase for Head Start. That increase includes $1.1 
billion to make sure every Head Start program serves children 
for a full school day and a full year, which will help make 
sure kids start kindergarten ready to learn.
    I am also pleased to see the President's budget includes an 
increase of $370 million for the Child Care and Development 
Block Grant. This includes $266 million to implement the safety 
and quality improvements that were contained in last year's 
reauthorization, which the Senate approved last November with 
an overwhelming bipartisan vote of 88-1, due in no small part 
to the leadership of Vice Chairwoman Mikulski. We thank her for 
that.
    Mr. Chairman, this bipartisan support shows that we all 
agree that quality childcare is essential to children's 
learning and their development, and it also helps parents to 
work, attend school, or pursue job training. So I hope we can 
all agree that that funding is needed to help working families 
to succeed.
    The budget also requests $490 million in new funding for a 
department-wide initiative to address the growing problem of 
antibiotic resistance.
    As you know, Virginia Mason Hospital in Seattle experienced 
a resistant outbreak earlier this year, which sickened over 30 
people, possibly contributing to several deaths. These superbug 
outbreaks in hospitals are tragic and concerning.
    Secretary Burwell, I applaud your proposal to address this 
very serious and increasing threat. I am also pleased that the 
President's budget maintains investments in helping families 
getting high-quality, affordable healthcare through the ACA, 
including $629 million to operate health insurance marketplace 
functions in over 30 States. This will allow Congress to 
continue working to improve quality, expand coverage, and drive 
down costs for our families.
    The department's request also takes important steps forward 
in terms of helping seniors get the care that they need. Every 
year, over 4 million Americans, an average of 10,000 a day, 
turn 65. The growing Medicare population is straining CMS's 
operating budget, so I am glad the budget proposes additional 
resources to support that increasing workload.
    Your budget also includes $875 million in funding for the 
Administration for Community Living nutrition services. That is 
a $60 million increase, which provides really vital support for 
older Americans nationwide, many of whom are low income.
    I believe strongly that all families should be able to get 
the healthcare they need when and where they need it, which is 
why health centers and the National Health Service Corps are 
priorities of mine.
    The agreement the President signed into law to fix the 
broken SGR system offered important support for health centers 
and the National Health Service Corps. And I'm glad the 
President's budget would help further expand access to these 
important resources for families across our country.
    Now while I strongly support many of the priorities 
reflected in this budget, I do want you to know I am very 
concerned by the proposal to cut funding for breast and 
cervical cancer screenings for women. The Affordable Care Act 
expanded preventive services to millions of working women and 
has helped them save $483 million in out-of-pocket costs. But 
there are still today an estimated 4.5 million women who remain 
uninsured and are eligible for the cancer screening services 
that that program funds.
    Mr. Chairman, I hope we can work together on a way to avoid 
cutting that extremely important program.
    Our country has come a long way toward providing 
affordable, quality healthcare but there are many challenges 
ahead when it come to making our healthcare system work for 
families and put their needs first. Families have made it very 
clear that they don't want to go back to the bad old days when 
lobbyists and insurance companies, not patients, not the 
families themselves, had the power in our healthcare system.
    Secretary Burwell, I know you share my hope that both 
parties can work together to build on the progress we have made 
so far and continue making improvements. That is certainly 
something I hope we can do in this committee, and I look 
forward to working with you and all of my colleagues today and 
in the coming weeks and months.
    With that, I will turn it back over to you, Mr. Chairman, 
and thank you.
    Senator Blunt. Thank you, Senator Murray.
    Secretary Burwell, we are pleased you are here and look 
forward to your opening statement.

                 SUMMARY STATEMENT OF SYLVIA M. BURWELL

    Secretary Burwell. Thank you so much, Chairman Blunt, 
Ranking Member Murray, and members of the committee. Thank you 
all for having me up today to have an opportunity to talk about 
the HHS budget.
    We saw the power of common ground in our recent bipartisan 
SGR repeal, and I applaud all of your efforts and hard work 
that got that passed.
    The President's budget proposes to end sequestration, fully 
reversing it for domestic priorities in 2016, matched by equal 
dollar increases for defense funding. Without further 
congressional action, sequestration will return in full in 
2016, bringing discretionary funding to its lowest level in a 
decade, adjusted for inflation.
    We need a whole-of-government solution, and I hope that 
both parties can work together to achieve a balanced, common-
sense agreement.
    The budget before you makes critical investments in 
healthcare, science, innovation, and human services. It 
maintains our responsible stewardship of the taxpayers' 
dollars. It strengthens our work together with Congress to 
prepare our Nation for key challenges both at home and abroad.
    For HHS, the budget proposes $83.8 billion in discretionary 
budget authority, $75.8 billion of which is for activities 
funded by this subcommittee. This $4.8 billion increase will 
allow our department to deliver impact today, as well as lay a 
strong foundation for tomorrow.
    It is a fiscally responsible budget, which in tandem with 
accompanying legislative proposals would save taxpayers a net 
estimated $250 billion over the next decade. In addition, it's 
projected to continue slowing the growth in Medicare spending. 
It can secure $423 billion in savings as we build a better 
system that is smarter and a healthier delivery system.
    In terms of providing all Americans with access to 
affordable, quality healthcare, it builds on our historic 
progress in reducing the number of uninsured and improving 
coverage for families who already had insurance. We saw a 
recent example of this progress with about 11.7 million 
Americans signing up or re-enrolling in health insurance 
through the marketplaces during this open enrollment.
    The budget covers newly eligible adults in 28 States plus 
D.C., which expanded Medicaid, and it improves access to 
healthcare for Native Americans.
    To support communities throughout the country, including 
underserved communities, it invests $4.2 billion in health 
centers and $14.2 billion to bolster our Nation's health 
workforce. It supports more than 15,000 National Health Service 
Corps clinicians serving nearly 16 million patients in high-
need areas, and it helps address health disparities.
    To advance our common interest in building a better, 
smarter, healthier delivery system, it supports improvements to 
the way care is delivered, providers are paid, and information 
is distributed.
    To advance our shared vision for leading the world in 
science and innovation, the budget increases funding for NIH by 
$1 billion to advance biomedical and behavioral research, among 
other priorities.
    In addition, it invests $215 million in the Precision 
Medicine Initiative, a new cross-departmental effort focused on 
developing treatments, diagnostics, and prevention strategies 
tailored to the genetic characteristics of individual patients.
    To further a common interest in providing Americans with 
the building blocks of success in every stage of life, this 
budget outlines an ambitious plan to make affordable, quality 
childcare available to every working- and middle-class family 
with young children. It supports evidence-based interventions 
to protect youth in foster care. And it invests to help older 
Americans live with dignity in their homes and communities, to 
protect them from identity theft.
    To keep Americans healthy, the budget strengthens our 
public health infrastructure with $975 million for domestic and 
international preparedness, including critical funds to 
implement the global health security agenda and its core 
strategy of prevention, detection, and response.
    It also invests in behavioral health services and substance 
abuse prevention. It includes more than $99 million in new 
funding to combat prescription opioid and heroin abuse, 
dependence, and overdose.
    This is a top priority for our department, and I want to 
thank many members of this committee for your leadership in 
this area.
    Finally, as we look to leave our department stronger, the 
budget invests in our shared priorities of cracking down on 
waste, fraud, and abuse, initiatives that are projected to 
yield almost $22 billion in gross savings from Medicare and 
Medicaid over the next decade. We are also addressing our 
Medicare appeals backlog with a coordinated approach.
    I also want to assure you that I am personally committed to 
responding promptly and thoroughly to concerns and 
communication with and from Members of Congress, and close by 
taking a moment to say how proud I am of our HHS employees, 
from their work combating Ebola, to assisting the unaccompanied 
children at the border, to the commitment they show day in and 
day out, as they routinely go above and beyond the call of 
their work to help their fellow Americans obtain the building 
blocks of healthy and productive lives.
    I look forward to working closely with all of you as we 
advance our common interests on behalf of the American people. 
Thank you, and with that, I look forward to your questions.
    [The statement follows:]
                Prepared Statement of 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 2016 Budget for the Department of Health and Human Services 
(HHS).
    I want to begin by thanking members of this Subcommittee and your 
colleagues in the Senate and the House of Representatives for the 
bipartisan, bicameral efforts you have just undertaken in passing the 
Medicare Access and CHIP Reauthorization Act of 2015. As you know, this 
Act establishes a long-term policy solution to fix Medicare's flawed 
Sustainable Growth Rate (SGR) formula, replacing a broken system with 
one that offers predictability and advances value-based payments that 
reward quality and efficiency. The legislation also includes similar 
policies that were proposed in the President's Budget, such as 
requiring that Social Security numbers be removed from Medicare 
identification cards, increasing income-related premiums for Medicare 
beneficiaries, and reforming payments to post acute providers. These 
policies, along with other changes in the legislation, will help 
protect the integrity of Medicare and contribute to slowing healthcare 
cost growth.
    I also want to express my gratitude for continued funding for the 
Children's Health Insurance Program, which provides comprehensive and 
affordable health coverage to millions of children. In addition, thank 
you for your continued support for critical safety net programs, 
including our Nation's health centers, the Home Visiting Program, the 
National Health Service Corps, and Teaching Health Centers Graduate 
Medical Education Program. These programs will ensure that millions of 
Americans will continue to have access to the healthcare and services 
they need to lead healthy and productive lives.
    Five years ago, another major piece of legislation was enacted. And 
today, thanks to the Affordable Care Act (ACA), middle class families 
have more security, and since the passage of the ACA, about 16.4 
million uninsured people have gained health insurance coverage.. In the 
private market, millions more now have access to expanded coverage for 
preventive healthcare services, such as a mammogram or flu shot, 
without cost sharing. At the same time, as a Nation we are spending our 
healthcare dollars more wisely and starting to receive higher quality 
care.
    In part due to the ACA, households, businesses, and the Federal 
Government are now seeing substantial savings. Today, healthcare cost 
growth is at exceptionally low levels, and premiums for employer 
sponsored health insurance are about $1,800 lower per family on average 
than they would have been had trends over the decade that preceded the 
ACA continued. Across the board, the Department has continued its 
commitment to the responsible stewardship of taxpayer dollars through 
investments in critical management priorities. We have strengthened our 
ability to combat fraud and abuse and advance program integrity, 
further driving savings for the taxpayer while enhancing the efficiency 
and effectiveness of our programs.
    The Department has done important work addressing historic 
challenges, including the coordinated whole-of-government responses to 
Ebola both here at home and abroad and to last year's increase in 
unaccompanied children crossing the Southwest border into Texas.
    The President's fiscal year 2016 Budget for HHS builds on this 
progress through critical investments in healthcare, science and 
innovation, and human services. The Budget proposes $83.8 billion in 
discretionary budget authority, an increase of $4.8 billion from fiscal 
year 2015 appropriations. This additional funding will allow the 
Department to make the investments that are necessary to serve the 
millions of American people who count on our services every day, while 
laying the foundation for healthier communities and a stronger economy 
for the middle class in the years to come. The Budget also further 
strengthens the infrastructure needed to prevent, prepare for, and 
respond to future challenges effectively and expeditiously.
    The Department's Budget request recognizes our continued commitment 
to balancing priorities within a constrained budget environment through 
legislative proposals that, taken together, would save the American 
people a net estimated $228.2 billion in HHS programs over 10 years. 
The Budget builds on savings and reforms in the ACA with additional 
measures to strengthen Medicare and Medicaid, and to continue the 
historic slow-down in healthcare cost growth. Medicare proposals in our 
Budget, for example, more closely align payments with the costs of 
providing care, encourage healthcare providers to deliver better care 
and better outcomes for their patients, improve access to care, and 
create incentives for beneficiaries to seek high value services.
Providing all Americans with Access to Quality, Affordable Health Care
    The President's fiscal year 2016 Budget request builds on progress 
made to date by focusing on access, affordability, and qualit--goals 
that we share with Congress and hope to work on together, in 
partnership, moving forward. The Budget also continues to make 
investments in Federal public health and safety net programs to help 
individuals without coverage get the medical services they need, while 
strengthening local economies.
    Expanding Options for Consumers through the Health Insurance 
Marketplaces.--The ACA is making quality, affordable health coverage 
available to millions of Americans who would otherwise be uninsured. As 
of March more than 11 million consumers selected a plan or were 
automatically re-enrolled through the Health Insurance Marketplaces for 
coverage in 2015. At the same time, consumers are seeing more choice 
and competition. There are over 25 percent more issuers participating 
in the Marketplace in 2015 compared to 2014. Not only that, in 2015, 
nearly 8 in 10 Federal Marketplace customers can get coverage for $100 
or less per month after applicable tax credits.
    Partnering with States to Expand Medicaid for Low-Income Adults.--
The ACA provides full Federal funding to cover newly eligible adults in 
States that expand Medicaid up to 133 percent of the Federal poverty 
level through 2016, and covers no less than 90 percent of costs 
thereafter. This increased Federal support has enabled 28 States and 
the District of Columbia to expand Medicaid coverage to more low-income 
adults many of whom are employed individuals. Just recently we saw 
another State, Indiana, join us to bring much needed access to 
healthcare coverage to a State-estimated 350,000 uninsured low-income 
residents. Across the country, as of January 2015, nearly 11.2 million 
additional individuals are now enrolled in Medicaid and CHIP compared 
to the summer of 2013. As Secretary, I am personally committed to 
working with Governors across all 50 States to expand Medicaid in ways 
that work for their States, while protecting the integrity of the 
program and those it serves.
    Improving Access to Health Care for American Indians and Alaska 
Natives (AI/AN).--Reflecting the President's commitment to improving 
health outcomes across tribal nations, the Budget includes $6.4 billion 
for the Indian Health Service to strengthen programs that serve over 
2.2 million American Indians and Alaska Natives at over 650 healthcare 
facilities across the United States. The request fully funds estimated 
Contract Support Costs in fiscal year 2016 and proposes to modify the 
program in fiscal year 2017 by reclassifying it as a mandatory 
appropriation, creating a longer-term solution.
    Bolstering the Nation's Health Workforce.--The Budget includes a 
$14.2 billion investment in our Nation's healthcare workforce to 
improve access to healthcare services, particularly in rural and other 
underserved communities. That includes support for over 15,000 National 
Health Service Corps clinicians, who will serve the primary care, 
mental health, and dental needs of nearly 16 million patients in high-
need areas across the country. Nearly half of all current Corps 
providers work in rural communities. The Budget also creates new 
funding for graduate medical education in primary care and other high-
need specialties, which will support more than 13,000 residents over 10 
years, and advance the Administration's goal of higher-value healthcare 
that reduces long-term costs.
    To continue encouraging provider participation in Medicaid, the 
Budget invests $6.3 billion to extend the enhanced Medicaid 
reimbursement rate for primary care services, and makes strategic 
investments to encourage primary care by expanding eligibility to 
obstetricians, gynecologists, and non-physician practitioners. A 
January 2015 study by University of Pennsylvania and Urban Institute 
researchers found that the share of Medicaid enrollees who successfully 
got appointments with primary care providers grew by nearly 8 
percentage points between 2012 and 2014, when the program was fully 
implemented.
    Investing in Health Centers.--Health centers are essential sites 
where America's most vulnerable populations can access the healthcare 
they need. This is true for over 442,000 individuals in Missouri and 
over 836,000 individuals in Washington. Health centers are also key in 
reducing the use of costlier care through emergency departments and 
hospitals. The Budget includes $4.2 billion for health centers to serve 
approximately 28.6 million patients in fiscal year 2016, including an 
estimated 10.6 million rural Americans at more than 9,000 sites in 
medically underserved communities throughout the country. The Budget 
also provides the resources to open 75 new health center sites in areas 
of the country where they currently do not exist, including 30 
projected new sites in rural areas.
Delivering Better Care and Spending our Health Care Dollars Wisely
    If we find better ways to deliver care, pay providers, and 
distribute information, we can receive better healthcare and spend our 
dollars more wisely, all the while supporting healthier communities and 
a stronger economy. To build on and drive progress on these priorities, 
we are focused on the following three key areas:
    Improving the Way Care is Delivered.--The Administration 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. HHS believes 
that incentivizing the provision of preventive and primary care 
services will improve the health and wellbeing of patients and slow 
cost growth over the long run through avoided hospitalizations and 
additional office visits. The Administration's efforts around patient 
safety and quality have made a difference--reducing hospital 
readmissions in Medicare by nearly eight percent, translating into an 
estimated 150,000 fewer readmissions between January 2012 and December 
2013 and reducing hospital-acquired conditions by 17 percent from 2010 
to 2013, saving an estimated 50,000 lives and decreasing healthcare 
spending by approximately $12 billion according to preliminary 
estimates.
    Improving the Way Providers are Paid.--The Administration is 
testing and implementing new payment models that reward value, quality, 
and care coordination--rather than volume. HHS has seen promising 
results on cost savings with alternative payment models: already, 
existing Accountable Care Organizations (ACOs) programs have generated 
combined total program savings of $417 million to Medicare. To shift 
Medicare reimbursement from volume to value, and further drive progress 
in the healthcare system at large, the Department has announced its 
goal of making 30 percent of traditional, or fee-for-service, Medicare 
payments value providers through alternative payment models by 2016 and 
50 percent by 2018.
    Improving the Way Information is Distributed.--The Administration 
is working to create transparency of cost and quality information and 
to bring electronic health information to the point of care--enabling 
patients and providers to make the right decisions at the right time to 
improve health and care. The Centers for Medicare & Medicaid Services 
(CMS) is making strides to expand and improve its provider compare 
websites, which empower consumers with information to make more 
informed healthcare decisions, encourage providers to strive for higher 
levels of quality, and drive overall health system improvement. To 
improve communication and enhance care coordination for patients, the 
fiscal year 2016 Budget also includes a substantial investment ($92 
million) in efforts supporting the adoption, interoperability, and 
meaningful use of electronic health records.
Leading the World in Science and Innovation
    Investments in science and innovation have reshaped our 
understanding of health and disease, advanced life-saving vaccines and 
treatments, and helped millions of Americans live longer, healthier 
lives. With the support of Congress, there is more that we can do 
together. The President's fiscal year 2016 Budget request lays the 
foundation to maintain our Nation's global edge in medical research. 
This Budget for the National Institutes of Health (NIH) supports 
ongoing research and provides real investments in innovative science.
    Advancing Precision Medicine.--The fiscal year 2016 Budget includes 
$215 million for the Precision Medicine Initiative, a new cross-
Department effort focused on developing treatments, diagnostics, and 
prevention strategies tailored to the genetic characteristics of 
individual patients. This effort includes $200 million for NIH to 
launch a national research cohort of a million or more Americans who 
volunteer to share their information, including genetic, clinical and 
other data to improve research, as well as to invest in expanding 
current cancer genomics research, and initiating new studies on how a 
tumor's DNA can inform prognosis and treatment choices. The Department 
will work to modernize the regulatory framework to aid the development 
and use of molecular diagnostics, and develop technology and define 
standards to enable the exchange of data, while ensuring that 
appropriate privacy protections are in place. With the support of 
Congress, this funding would allow the Department to scale up the 
initial successes we have seen to date and bring us closer to curing 
the chronic and terminal diseases that impact millions of Americans 
across the country.
    Supporting Biomedical Research.--The fiscal year 2016 Budget 
includes $31.3 billion for NIH, an increase of $1 billion over fiscal 
year 2015, to advance basic biomedical and behavioral research, harness 
data and technology for real-world health outcomes, and prepare a 
diverse and talented biomedical research workforce. This research is 
critical to maintaining our country's leadership in the innovation 
economy, and can result in life-changing breakthroughs for patients and 
communities. For example, that NIH estimates it will be able to spend 
$638 million under this Budget request on Alzheimer's research, an 
increase of $51 million over fiscal year 2015, which will position us 
to drive progress on recent advances in our understanding of the 
genetics and biology of the disease, including drugs currently in 
clinical trials, and those still in the pipeline.
Ensuring the Building Blocks for Success at Every Stage of Life
    As part of the President's plan to bolster and expand the middle 
class, the Budget includes a number of proposals that help working 
Americans meet the needs of their families--including young children 
and aging parents.
    Investing in Early Learning.--High-quality early learning 
opportunities both promote children's healthy development and support 
parents who are balancing work and family obligations. Across the 
United States, many American families face real difficulties finding 
and affording quality child care and early education. In 2013, parents 
on average paid more than $10,000 per year for full-time care for an 
infant at a child care center--higher than the average cost of a year's 
in-State tuition and fees at a public 4-year college. The Budget 
outlines an ambitious plan to make affordable, quality child care 
available to every low-income and middle-class family with young 
children; to expand access to high-quality early learning opportunities 
through the Head Start and Early Head Start programs; and to invest in 
voluntary, evidence-based home visiting programs that have been shown 
to leave long-lasting, positive impacts on parenting skills, children's 
development, and school readiness. These investments complement 
proposals at the Department of Education to provide high-quality 
preschool to all 4 year olds from low-and moderate-income families and 
expand programs for middle-class children as well.
    The President's child care proposal builds on the reforms passed by 
Congress in the bipartisan reauthorization of the Child Care and 
Development Block Grant enacted last fall. The proposal makes a 
landmark investment of an additional $82 billion over 10 years in the 
Child Care and Development Fund (CCDF), which by 2025 would expand 
access to more than 1 million additional children under age four, 
reaching a total of more than 2.6 million children overall in the 
program. At the same time, the proposal provides resources to help 
States raise the bar on quality, and design programs that better serve 
families facing unique challenges in finding quality care, such as 
those in rural areas or working non-traditional hours.
    The Budget includes an additional $1.5 billion above fiscal year 
2015 to improve the quality of Head Start services and expand access to 
Early Head Start, including through Early Head Start--Child Care 
Partnerships. The proposal will ensure that all Head Start programs 
provide services for a full school-day and a full-school-year and 
increase the number of infants and toddlers served in high-quality 
early learning programs. It will also ensure that program funding keeps 
pace with inflation and that the program can restore enrollment back to 
the 2014 level.
    Research by the President's Council of Economic Advisors indicates 
that investments in high-quality early education generate economic 
returns of over $8 for every $1 spent. Not only that, studies show 
high-quality early learning programs result in better outcomes for 
children across the board--with children more likely to do well in 
school, find good jobs and greater earnings, and have fewer 
interactions with the criminal justice system. These programs also 
strengthen parents' abilities to go to work, advance their career, and 
increase their earnings. That is why the Administration has outlined a 
series of measures, including tax cuts for working families, to advance 
our focus on improving quality, while also dramatically expanding 
access.
    Supporting Older Adults.--The number of older Americans age 65 and 
older with severe disabilities--defined as 3 or more limitations in 
activities of daily living--that are at greatest risk of nursing home 
admission, is projected to increase by more than 20 percent by the year 
2020. With 2015 marking the year of the White House Conference on 
Aging, the Department's Budget request includes $1.7 billion for Aging 
Services within the Administration for Community Living for investments 
that address the needs of older Americans, many of whom require some 
level of assistance to continue living independently or semi-
independently within their communities. The Budget includes common-
sense reforms that help to protect older Americans from identity theft, 
while supporting increased funding to support family caregivers and to 
expand home and community-based services and supports.
    Improving Child Welfare.--The Department's Budget also proposes 
several improvements to child welfare programs that serve children who 
have been abused and neglected or are at risk of maltreatment. The 
Budget includes a proposal that has generated bipartisan interest that 
would provide $750 million over 5 years for an innovative collaboration 
between the Administration for Children and Families (ACF) and CMS that 
would assist States to provide evidence-based interventions to youth in 
the foster care system to reduce the over-prescription of psychotropic 
medications. There is an urgent need for action: ACF data show that 18 
percent of the approximately 400,000 children in foster care were 
taking one or more psychotropic medications at the time they were 
surveyed. It also requests $587 million over 10 years in additional 
funding for prevention and post-permanency services for children in 
foster care, most of which must be evidence-based or evidence-informed. 
It includes savings of $69 million over 10 years to promote family-
based foster care for children with behavioral and mental health needs, 
as an alternative to congregate care, and provides increased oversight 
of congregate care when such placements are determined to be necessary.
Keeping Americans Healthy
    The President's fiscal year 2016 Budget strengthens our public 
health infrastructure, invests in behavioral health services, and 
prioritizes other critical health issues.
    Investing in Domestic and International Public Health 
Preparedness.--The health of people overseas directly affects America's 
safety and prosperity, with far-reaching implications for economic 
security, trade, the stability of foreign governments, and the well-
being of U.S. citizens abroad and at home. The Budget includes $975 
million for domestic and international public health preparedness 
infrastructure, including an increase of $12 million for Global Health 
Security Agenda implementation to build the capacity for countries to 
detect and respond to potential disease outbreaks or public health 
emergencies and prevent the spread of disease across borders.
    As new infectious diseases and public health threats emerge, HHS 
continues to invest in efforts to bolster the Nation's preparedness 
against chemical, biological, nuclear, and radiological threats. This 
includes a $391 million increase for Project BioShield to support 
procurements and replenishments of new and existing countermeasures and 
to advance final stage development of new products, and an increase of 
$37 million to replace expiring countermeasures and maintain current 
preparedness levels in the Strategic National Stockpile.
    Combatting Antibiotic Resistant Bacteria.--The Centers for Disease 
Control and Prevention estimates that each year at least two million 
illnesses and 23,000 deaths are caused by antibiotic-resistant bacteria 
in the United States alone. The Budget nearly doubles the amount of 
Federal funding for combating and preventing antibiotic resistance 
within HHS to more than $990 million. The funding will improve 
antibiotic stewardship; strengthen antibiotic resistance risk 
assessment, surveillance, and reporting capabilities; and drive 
research innovation in the human health and agricultural sectors.
    Addressing Prescription Drug and Opioid Misuse and Abuse.--The 
misuse and abuse of prescription drugs impacts the lives of millions of 
Americans across the country, and costs the American economy tens of 
billions of dollars in lost productivity and increased healthcare and 
criminal justice expenses. In 2009, total drug overdoses overtook every 
other cause of injury death in the United States, outnumbering 
fatalities from car crashes for the first time. In 2012 alone, 259 
million opioid prescriptions were written--enough for every American 
adult to have a bottle. As part of a new, aggressive, multi-pronged 
initiative, the Budget includes more than $99 million in new funding 
this year in targeted efforts to reduce the prevalence and impact of 
opioid use disorders. The Budget also includes improvements in Medicare 
and Medicaid, including a proposal to require States to track high 
prescribers and utilizers of prescription drugs in Medicaid, which 
would save $710 million over 10 years and bolster other efforts to 
reduce abuse of prescription drugs.
    Improving Access to Mental Health Services.--Mental and medical 
condition comorbidity results in decreased length and quality of life, 
and increased functional impairment and cost. Patients diagnosed with a 
serious mental illness die as much as 25 years earlier than other 
Americans, and they are also among the least likely to seek treatment. 
The Budget includes an increase of $35 million, a total of $151 million 
for the President's Now is the Time initiative to focus on prevention 
and treatment of mental health issues among students and young adults. 
Reaching 750,000 young people per year and training thousands of 
additional behavioral health professionals and paraprofessionals, this 
investment represents a substantial step toward reducing barriers for 
individuals seeking care. The additional funds will be used to increase 
workforce capacity across the Nation by expanding an existing 
partnership between SAMHSA and HRSA that addresses the number of 
licensed behavioral health professionals available and by creating a 
Peer Professionals program to provide training for individuals who have 
experienced their own behavioral health issues to help reach those in 
need of treatment. In addition, this increase will raise awareness 
about mental and substance use disorders and increase Americans' 
willingness to seek help through a social media campaign and other 
outreach efforts. The Budget also supports ongoing research at the 
National Institutes of Mental Health to prevent the first break of 
serious mental illness and change the trajectory of these disorders. 
Finally, the Budget proposes the elimination of Medicare's 190-day 
lifetime limit on inpatient psychiatric facility services, removing one 
of the last obstacles to behavioral health parity in the Medicare 
benefit.
Leaving the Department Stronger
    The fiscal year 2016 Budget request positions the Department to 
most effectively fulfill our core mission by investing in a number of 
key management priorities that will strengthen our ability to combat 
fraud, waste, and abuse, strengthen program integrity, and enable 
ongoing cybersecurity efforts, among other areas.
    Strengthening Program Integrity.--The fiscal year 2016 Budget 
continues to build on progress made by the Administration to eliminate 
excess payments and fraud. The Budget includes new investments in 
program integrity totaling $201 million in fiscal year 2016 and $4.6 
billion over 10 years. This includes, for example, the continued 
funding of comprehensive efforts to combat healthcare fraud, waste, and 
abuse through prevention activities, improper payment reductions, 
provider education, audits and investigations, and enforcement. We 
thank this Committee for providing the full Health Care Fraud and Abuse 
Control (HCFAC) discretionary cap adjustment in the final fiscal year 
2015 appropriation. The fiscal year 2016 Budget again requests the full 
discretionary cap adjustment be provided. This investment builds on 
important gains over the course of the past several years: from 2009 to 
2014, programs supported by HCFAC have returned over $22.5 billion in 
healthcare fraud related payments. Together, the Department's proposed 
program integrity investments will yield $22 billion in gross savings 
for Medicare and Medicaid over 10 years.
    Reforming the Medicare Appeals Process.--Between fiscal year 2009 
and fiscal year 2014, the number of appeals received by the Office of 
Medicare Hearings and Appeals has increased by more than 1300 percent, 
which has led to a backlog that is projected to reach 1 million appeals 
by the end of fiscal year 2015. The Department has undertaken a three-
pronged strategy to improve the Medicare Appeals process: (1) Take 
administrative actions to reduce the number of pending appeals and more 
efficiently handle new cases that are entering the appeals process; (2) 
Request new resources to invest at all levels of appeal to increase 
adjudication capacity and implement new strategies to alleviate the 
current backlog; and (3) Propose legislative reforms that provide 
additional funding and new authorities to address the appeals volume. 
The fiscal year 2016 Budget includes a comprehensive legislative 
package of seven proposals aimed both at helping HHS process a greater 
number of appeals and more efficiently handle new cases that are 
entering the appeals process, and requests additional resources for 
CMS, OMHA, and the Departmental Appeals Board to enhance their capacity 
to process appeals.
    Protecting Unaccompanied Children.--HHS is responsible for ensuring 
that unaccompanied children who are apprehended by immigration 
authorities are provided shelter while their immigration cases are 
adjudicated. In the summer of 2014, the Administration responded to 
significant increase in the number of apprehended children with an 
aggressive coordinated Federal response focused on providing 
humanitarian care for the children as well as on stronger deterrence, 
enforcement, foreign cooperation, and border security. The number of 
unaccompanied children placed in ACF's custody thus far in fiscal year 
2015 is below the fiscal year 2014 level for the comparable period, and 
HHS, DHS, and the other agencies with responsibilities for 
unaccompanied children expect arrival levels to remain stable. To 
ensure that ACF can care for all children referred from DHS in fiscal 
year 2016, and to promote the responsible stewardship of taxpayer 
dollars, the Budget includes level base funding from fiscal year 2015 
of $948 million and creates a contingency fund that would only trigger 
additional resources if the fiscal year 2016 caseload exceeds levels 
that could be supported with existing program funds.
    Improving Federal Spending Transparency.--A key Congressional 
priority is implementation of the Digital Accountability and 
Transparency Act of 2014 (DATA Act) which seeks to improve the 
transparency of Federal spending. HHS plays a critical, government-wide 
role in its implementation promoting transparency, facilitating better 
decisionmaking, and improving operational efficiency. The HHS Budget 
request includes $10 million to begin implementing new data standards, 
assessing impacts, facilitating long term policies, processes, and 
systems, and establishing the Section 5 grants pilot in coordination 
with OMB.
Conclusion
    Members of the Committee, thank you for the opportunity to testify 
today. The President's fiscal year 2016 Budget request for HHS makes 
the investments critical for today while laying the foundation for a 
stronger economy for the middle class. I am looking forward to working 
closely with Congress and Members of this Committee on these priorities 
moving forward so that together we can best deliver impact for those we 
serve--the American people. I welcome any questions you may have.

    Senator Blunt. Thank you, Madam Secretary. We have votes 
scheduled at 11:45, so it will be my intention to be done when 
those votes occur. We will do 5-minute rounds, and we will go 
with Senator Murray and I, and the ranking member and the 
chairman of the full committee, and then we will alternate by 
order of arrival after that. And I should have time for a 
second round. And of course, there will be a week to submit 
questions in writing, if we don't get to those questions today.

                      EXCELLENCE IN MENTAL HEALTH

    To start, I am going to ask a couple of questions about 
mental health and hope to get other questions in later, so that 
everybody has time to ask questions here.
    First of all, we were able to get passed last year the 
Excellence in Mental Health Act, that Senator Stabenow and I 
cosponsored, in a way that allows States to be part of an 
eight-State pilot. I just want to thank you and your staff for 
working with us on those guidelines.
    There was one late thing that still hadn't been decided 
that was decided yesterday, about what the boards of groups 
that apply need to look like. And hopefully we will have not 
only a number of States apply, but some sense that there are 
more States out there, and the country is ready to begin to 
treat these mental health issues like all other health issues.
    I think that is a very important place for us to go, and 
hopefully we can do what we can in this committee to help us 
get there.
    On the GAO report on mental health, as it relates to the 
department, could have been better. I believe just in the last 
few days, the department is going to move forward and look at 
those GAO recommendations. Of the 30 mental health programs out 
there, 13 are under SAMHSA. Four of those, apparently, there 
was no real plan to evaluate those, and that was one of the 
criticisms in the GAO report.
    I'm just wondering, as you look at that report, as you look 
at SAMHSA, as you look at mental health generally as it relates 
to healthcare, one, your response to the GAO report, and two, 
is there anything else you want to say about the direction you 
hope to go with these mental health issues?
    Secretary Burwell. I think it is an important and critical 
time with the passage of the Affordable Care Act, the 
legislation that you passed, and mental health parity. I 
believe that, as a Nation, we are poised to take the biggest 
step we have taken in a very long time, to put these issues, 
behavioral health and mental health issues, on parity and to 
make progress on them. We look forward to doing that.
    With regard to our conversations with you and Senator 
Stabenow, and thank you both for your leadership, we are going 
to try to beat the statutory deadlines that have been put in to 
implement your bill. The idea is that we can get that done and 
done quickly and get these things in place, so we have those 
eight States up and running, and continuing to do the work that 
it takes to implement mental health parity.
    And that is about payment systems. That's about stigma. 
That's about how we implement our grant programs, which brings 
me to the GAO issue.
    In the GAO report, I think there were two fundamental 
issues that we take very seriously. One has to do with the 
issue of coordination and making sure that we are coordinating 
across the government. I asked SAMHSA and the Assistant 
Secretary for Planning and Evaluation to come together to help 
do that inter- and intra-government coordination.
    With regard to the question of our grant-making abilities 
and the question of that evaluation, I think you all know we 
have a new acting Deputy Secretary, Dr. Mary Wakefield, who is 
the highest ranking nurse in the Federal Government. And she 
comes from HRSA. So HRSA has made a lot of progress, with 
regard to this question of grants and evaluation. And we are 
going to see if we can share some of the best practices from 
our department and see how we can continue to make progress on 
this issue of evaluation.
    Senator Blunt. Thank you. And I think we want to look at 
what we can do to help enable you to do exactly that.
    Secretary Burwell. Thank you.
    Senator Blunt. If there are things that need to be said in 
report language or moved around in the budget, let's talk about 
that and be sure we get on that track where this happens.
    I am going to go ahead and go to Senator Murray. A lot of 
questions that I might ask will be asked by others. We'll see 
what's left when we get back to me.

                         CONTRACEPTIVE COVERAGE

    Senator Murray. Okay, thank you, Mr. Chairman.
    Madam Secretary, for many 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 of contraception. In fact, women have saved 
over $483 million because of that provision.
    Unfortunately, there have been some ongoing reports of 
women across the country experiencing difficulties in securing 
guaranteed no-cost coverage from their plans. The Kaiser Family 
Foundation just released a report showing that there is still 
variation in how insurance carriers are adhering to the ACA 
requirement, and that not all methods may be covered without 
cost-sharing by women policyholders. As someone who cares very 
deeply about ensuring women have access to comprehensive 
healthcare, that is very concerning.
    [The link to the report follows:]

http://kff.org/womens-health-policy/report/coverage-of-contraceptive-
services-a-review-of-health-insurance-plans-in-five-states/

    Senator Murray. Has HHS identified the carriers that are 
requiring cost-sharing or declining coverage or otherwise 
limiting coverage for some of these contraceptive methods?
    Secretary Burwell. The issue has been brought up broadly to 
us, and it is an issue we continue to work to make sure that 
our guidelines are very clear about the requirements of the 
ACA. We have seen some of these issues arise in certain 
pharmaceuticals and drugs for HIV and other things. We are 
taking the steps to reinforce and be much clearer about our 
guidelines.
    With regard to the specific cases, as they come in--the 
Kaiser report was a general report--it is about us 
understanding where those specific issues are. And where there 
are those specific issues, we will take them and follow up.
    Senator Murray. And you plan to follow up on those?
    Secretary Burwell. We do plan to follow up, but it is a 
matter of the specifics being brought to us.
    We understand the general problem, and it is one of the 
things I continue to have conversations to make sure people 
know, making sure that whether it is providing the transparency 
of information about what you do and do not cover, or making 
sure there are things like this issue of the coverage, that we 
are being clear about what the law is and our guidelines.
    Senator Murray. Thank you very much. I really appreciate 
that.

                         ANTIBIOTIC RESISTANCE

    I was really pleased to see that you are requesting $490 
million to expand the multiagency effort to address antibiotic 
resistance. I talked about this in my opening remarks.
    Outbreaks of these dangerous superbugs are occurring more 
frequently in hospitals around the country. I talked about 
Virginia Mason Medical Center in my home State. In February, I 
sent a letter to the Food and Drug Administration, urging them 
to take action to improve safety for patients and a follow-up 
letter in March calling for a review of FDA's practices 
surrounding the type of scopes that were involved at Virginia 
Mason and other places.
    But we have to do more to prevent these infections from 
becoming resistant in the first place and to detect them as 
soon as possible. How would the additional resources that you 
have requested in your budget help with an outbreak at Virginia 
Mason or at any of these that we are seeing?
    Secretary Burwell. The Combating Antibiotic-Resistant 
Bacterial program, the CARB program, as we call it in our 
budget, has a number of elements in terms of what it is going 
to do.
    We put out a strategy in 2014. And in 2015, we put out the 
action plan to go with that strategy. And our budget is the 
budget to support the action plan.
    The elements are making sure that we are reducing the 
overuse, and that overuse is in both humans and animals. So my 
partner is Tom Vilsack at USDA, because the issue of 
antibiotics is an animal issue as well.
    First, some of the funds will be used to support the 
reduction of that, in terms of both humans prescribing as well 
as in terms of animals.
    Second, epidemiologically, we need to recognize quickly, as 
in the case of Virginia Mason. So CDC and others need the 
funding to make sure we have the epidemiologists to recognize 
when we have an outbreak, and we do it quickly.
    The third thing we need to do is make sure that we are 
actually continuing to do the research to develop things that 
aren't resistant as we go forward.
    Those are elements of the core strategy that the funds will 
go----
    Senator Murray. So it is a multipronged approach?
    Secretary Burwell. It is a multipronged approach. And much 
of this sits with the Department of Health and Human Services, 
but we work across the other departments as appropriate and as 
necessary, with USDA being our primary partner, because of the 
animal connection.
    Senator Murray. What about the issue of public health, like 
public health programs in Washington State? What role can they 
play?
    Secretary Burwell. That is a place where CDC is going to 
continue to work, and education is an important part of that. 
CDC is working with public health organizations as well as 
medical centers and training facilities to make sure people 
know about not overprescribing.
    So as part of the public health and population health, 
CDC's ability to go in, make sure of the training and education 
and tracking is very important.
    That's the other thing. We need better monitoring.
    Senator Murray. I think this is really important, and we 
are going to see a growing number of cases similar to what we 
saw with other arenas, unless we take this head on.
    So thank you for that.
    Secretary Burwell. It is millions already, so everyone has 
a sense--23,000 people died last year, but there are millions 
and millions of people who are contracting resistant disease. 
And much of that is occurring in hospitals, as you reflected 
with the situation at Virginia Mason.
    Senator Murray. Thank you, Mr. Chairman.
    Senator Blunt. Thank you, Senator.
    Senator Cochran says he will speak in order of arrival, but 
I would want him to know, when it comes to allocate 
subcommittee amounts, that you can talk in this committee 
anytime you want to, no matter what they say anywhere else.
    So on this side, I have Mr. Lankford, Mr. Alexander, Mr. 
Cassidy, Ms. Capito, and Senator Cochran. Over here, I have 
Senator Mikulski, Senator Reed, Senator Schatz, Senator 
Baldwin, and Senator Merkley.
    Senator Lankford.

                       RECOVERY AUDIT CONTRACTORS

    Senator Lankford. Thank you, Senator.
    Madam Secretary, thank you for being here and thanks for 
the engagement on this. Let me just go through a couple of 
questions quickly.
    There is a lot of conversation about the RAC audit process. 
That is not a new conversation to you at all. In your 
testimony, you even note that, starting in 2009, there is a 
1,300 percent increase in Medicare and the auditing, and what 
is happening in the appeals process. There is obviously a 
problem that has happened.
    So while you are accelerating the appeals process on this, 
I would like to get down to some of the root causes. There have 
been multiple changes to the RAC audit process. What is pending 
right now to continue to reform the RAC audit process in the 
days ahead, beyond just the appeals process, which we can talk 
about separately, but the root cause of this?
    Secretary Burwell. With regard to the RAC process, I think 
it is important to step back. What RACs were put in place to do 
was to work on program integrity issues in terms of Medicare 
spending. This is something that Dr. Coburn and others helped 
us focus on, and this was put in place so that we could do the 
tracking. It has tracked many, and returned quite a bit of 
money to the Federal Treasury, in the billions of dollars.
    There were negative unintended consequences that occurred. 
Congress has put a hold on certain parts of the RAC process.
    Administratively, we have taken steps to change the RAC 
process.
    Senator Lankford. So you all have made some changes. That 
is what I was trying to get at. What is next, of the changes 
that are pending still?
    Secretary Burwell. There are constraints that have been put 
on by the Congress in terms of our ability to go forward with 
RACs. That is something we want to do.
    There is also contracting. We have had challenges to 
contracting.
    So we need to get through those challenges and go through 
the regular process. We need to get the RACs back up and 
running, and we need to put in place and be able to implement 
the administrative changes, changes like, if it is not resolved 
within 90 days. We have these changes. We have done them 
administratively, but we are not being able to act on them 
fully as we like, because the process is not up and running. It 
is only on Part D.
    The other thing is it actually does interact. So there are 
a number of changes. If the RAC case does not go forward and is 
not successful, there will be nothing paid. So we tried to fix 
some of the incentive issues that were causing problems.
    It is related to the backlog issue, and the place where we 
believe we need some help from the Congress, and have had these 
conversations across a number of committees, are in that 
backlog process.
    Senator Lankford. So the recovery audit data warehouse, 
putting that in place to make sure you don't have duplication 
of contracting and such is happening, and your contractors 
doing multiple claims. Last year, there was a statement that 
came out to say that is in the process, trying to reform that 
to make sure contractors actually--do you know if there has 
been any progress?
    Secretary Burwell. That is one I have to get back to you 
on.
    [The information follows:]

    The recovery audit data warehouse was built to make sure that a 
particular claim is not selected for review by two or more review 
contractors. However, the warehouse was not designed to keep a 
particular provider or issue from being selected for review by multiple 
review contractors. That will be one of the jobs of CMS's redesigned IT 
system, the Provider Compliance Reporting System.
    The Provider Compliance Reporting System will combine data 
currently stored in the recovery audit data warehouse with several 
other data sources to provide CMS a single source of information about 
Medicare review programs from a provider perspective (e.g. when a 
provider received education on an issue, which claims were reviewed by 
the Medicare Administrative Contractor, Recovery Audit Contractor, or 
Supplemental Medical Review Contractor). Future plans include linking 
the Provider Compliance Reporting System to the Unified Case Management 
System. CMS plans to use this new system, among other tools, to ensure 
that the same provider/issue is not being reviewed by different 
contractors at the same time.
    Here is the timeline for getting Provider Compliance Reporting 
System up and running:
Completed Work
    March 13: CMS posted a pre-solicitation
     April 9: CMS/Office of Financial Management staff presented the 
Provider Compliance Reporting System to the CMS/Office of Informational 
Services Technical Review Board
Planned Work
    June 2015: Issue a Request for Proposal to ``8A'' firms
    Summer 2015: Accept and review bids
    September 30, 2015: Award the contract

    The statement of work requires bidders to build the Provider 
Compliance Reporting System on an existing CMS system that is connected 
to the CMS network (e.g. already has connectivity to all our 
contractors). Thus we can get it up and running faster than usual. I am 
hopeful that this module of the system will be operational by April 1, 
2016.

    Senator Lankford. Okay. That is one I know is pending. 
Dealing with good providers, obviously, they don't need to have 
this continuous RAC process coming through them, as frequent, 
or at least have smaller number pulled. Any kind of consequence 
for any contractor that is pulling a lot of files that are 
being overturned? So on both sides of this, there is an 
incentive for the contractors to also be good in the way they 
do it?
    Secretary Burwell. And the providers.
    Senator Lankford. And the providers also.
    Secretary Burwell. The provider review is something that we 
have put in place in these administrative changes.

                                 ICD-10

    Senator Lankford. Okay. Let me ask about another issue not 
near as contentious as RAC audits. It has been very smooth in 
the process, the ICD-10 and the transition to that. Let's do 
something simple, as well.
    This process transition, everyone is concerned about it, 
obviously. You all have dealt with it a long time in trying to 
work toward that transition. A lot of conversation about the 
advanced payments, what happens in the transition, how many 
small providers will be vulnerable during that time period?
    It is the same issue with the RACs. The RACs can be managed 
by large providers. By small providers, it is very, very 
difficult for them to have large files that are pulled. The 
concern is out there as well for ICD-10. What happens in the 
transition there, the in-between?
    The discussion has been out there on advanced payments. Is 
there a policy in place? Is there a process? Are there details 
coming out how it will be handled, or is that still being 
considered?
    Secretary Burwell. We now plan to go forward in October. I 
think you probably know there was a delay that was legislated. 
But right now, the plan is to go forward this October, in terms 
of moving to ICD-10.
    Senator Lankford. Right.
    Secretary Burwell. As part of that process, we have been 
doing testing and communication with large players and small 
players. Most of the large players have been ready and are 
ready.
    The question of any type of delay has to do with both cost, 
as well as the question of fairness and equity for those who 
are prepared to make the switch.
    The hospital associations have done surveys, and we have 
very high percentages of people reporting that they are ready. 
For any of those who are not, we are still in the process, for 
anyone, we will provide the technical assistance. We will go in 
to try to do the training.
    Senator Lankford. What about the advanced payments side of 
it? Is that still being discussed, to be able to help some of 
those individuals who are in the process?
    The concern is there is not going to be a smooth transition 
from one to the other. Is it your confidence that there will be 
a very smooth transition? There is not going to be a gap for 
the small providers?
    Secretary Burwell. We are hearing, that they are ready, and 
that there is only a very small group that is not ready. But 
during the period from now until October, we want to continue 
to work with that group.
    If you are hearing from those, it would be helpful to us--
--
    Senator Lankford. I think it is just important for us to 
know you are confident there is not going to be a gap in 
payments that are going to further expose some of these smaller 
providers.
    Secretary Burwell. We are planning to make sure that we can 
go through and that people will be ready, so that there won't 
be those kinds of problems.
    Senator Lankford. Okay.
    Senator Blunt. Senator Mikulski.
    Senator Mikulski. Thank you very much, Mr. Chairman.
    And of course, we welcome Secretary Burwell.
    Before I go to my questions to her, Mr. Chairman, I would 
like to bring to your attention and the committee's attention 
that a very dedicated staff member of this committee for 13 
years, who has worked for Senator Harkin, then worked for me, 
was also respected by Senator Specter, will be leaving. 
Adrienne Hallett who has worked for the committee for 13 years 
will be leaving to go to the executive branch. Actually, she is 
leaving to go to NIH, not for a clinical trial, but to again 
help Dr. Collins.
    So I would like the committee, if we could, to give 
Adrienne a round of applause.
    Secretary Burwell. And I will say thank you. Thank you to 
the committee.

                    AFFORDABLE CARE ACT DESIGNATION

    Senator Mikulski. Madam Secretary, of course, I'm glad to 
see you. So many of the great Federal assets of HHS are in 
Maryland, NIH, FDA, CMS, just to name the big three. And they 
have a tremendous impact on our economy, the jobs they provide 
and the jobs they stimulate.
    We could not have the robust biotech community we have in 
Maryland without you. So we will of course be talking about 
those issues, but I am going to go right to a Maryland issue in 
a part of the State that is very familiar to you, my mountain 
counties up in Appalachia.
    I have a situation where, due to the census, they are 
telling me that Allegany County, right next to our colleagues 
in West Virginia, you are a daughter of West Virginia, has lost 
their designation for Federal funding to qualify for the 
Affordable Care.
    I wrote you a letter in February. Your staff has been 
calling back and forth, but we have been told recently there is 
nothing you can do.
    Madam Secretary, I need you to look into this. You know 
Western Maryland. You know those mountain counties. You know 
they have lost population. You know that they have lost jobs. 
We don't want them to lose hope in their government.
    The loss, the impact is $2 million. That might not be a lot 
by our spending up here, but that enabled them to attract 
doctors. It enabled them to harness volunteers, like Mercy, 
that reduced dental visits.
    Could I have your assurance that you will actually look 
into this and not just have a lot of bureaucratic phone calls 
back and forth where they just say no?
    Secretary Burwell. Senator, I will look into it and see 
what the opportunities are for us to try and support this 
county.
    Senator Mikulski. And not just a list of grants they can 
apply for. They are not an urban county.

                   CHILDCARE DEVELOPMENT BLOCK GRANT

    So let me go on, though, to another issue, which really was 
a source of great exuberance among many of us, the fact that we 
worked together on a bipartisan basis to pass the Child Care 
Development Block Grant, working so closely with Senators 
Alexander and Burr, Senator Harkin and myself.
    Could you tell us what now, because we passed an 
authorization, what you are doing to implement it, and 
particularly where we worked so hard on the quality provisions? 
Sure, we wanted more money. Sure, we wanted more slots. But we 
really focused on a bipartisan basis.
    Could you tell us what is in the money to implement the 
law, and then enhance the quality and safety of our children?
    Secretary Burwell. Quality and safety are a large part of 
the implementation and what the money is for, and that is 
actually implementing the standards you all put in.
    The second part of the money--and thank you all for your 
leadership on this--is are funds, because one of the other 
things we were asked to do is to make sure that childcare for 
unusual circumstances, for parents who work different hours, 
for places that are not receiving and hard to reach.
    And this cuts across the entire suite as one looks at the 
continuum for children, home visiting, childcare in terms of 
implementing the authorization that you gave us. Also, in the 
budget is the childcare expansion that Senator Murray 
mentioned, the $82 billion over the 10-year period that would 
be for making sure that working families have access to 
childcare. And we don't want to forget Head Start and Early 
Head Start and those partnerships.
    So this is a continuum. We work to implement that piece in 
the context of improving quality and safety across all of those 
pieces.
    Senator Mikulski. But in a nutshell, it is a $370 million 
increase from last year. Is that correct?
    Secretary Burwell. That is correct.
    Senator Mikulski. Of that $370 million, about $270 million 
is for the new quality provision.
    Secretary Burwell. That is correct.
    Senator Mikulski. Do you feel that is adequate?
    Secretary Burwell. We do, to get us started. I think what 
we want to do is get the implementation started. And as we look 
at next year's budget, we will understand more.
    Senator Mikulski. And then you also have $100 million for 
pilot programs for this gap in care.
    Secretary Burwell. That is right.
    Senator Mikulski. I say to my colleagues, when we think of 
shift work, the days of factories are one thing, but, for 
example, we have nurses who are working the night shift.
    I have the National Security Agency that works 24/7. Many 
are women who are cryptographers keeping America safe, often 
single mothers.
    So I think we are on the right track. I also hope--my time 
is up--but that we could have additional conversation on the 
work that you are doing on both foster care and also on the 
unaccompanied children. Though the children seem to not be at 
the border the way they were, they are in our country and could 
continue to come. We cannot turn away from this very important 
issue.
    So I look forward to dialogue with you, and with the 
chairman and the ranking member.
    Secretary Burwell. Thank you.

                       ELECTRONIC HEALTH RECORDS

    Senator Blunt. Senator Alexander.
    Senator Alexander. Thanks, Mr. Chairman.
    Welcome, Madam Secretary. Senator Murray and I on the HELP 
Committee are trying to get a few things actually done. We have 
reported a bill on elementary and secondary education. We are 
moving ahead on higher education. As you know, we are going to 
get into innovation in medicine.
    One other area where I believe we could get something done 
is electronic health records, and you and I have talked about 
that. You talked about the year and 9 months left for you, and 
what I would like to do is to move up toward the top of your 
list and our list doing something about electronic health 
records.
    The government spent $28 billion subsidizing electronic 
health records. It sounded like a wonderful idea. But half the 
doctors have either tried and failed or are choosing not to 
participate in the program. Instead, they'll face Medicare 
penalties this year.
    Doctors don't like their electronic medical record systems, 
by and large. They say they disrupt the workflow and interrupt 
the doctor-patient relationship, and they haven't been worth 
the effort.
    An AMA commissioned study found electronic health records 
are the leading cause of physicians' dissatisfaction. A Medical 
Economics survey last year found nearly 70 percent of 
physicians say their electronic health records haven't been 
worth it.
    Now I have met already with Andy Slavitt. At your 
suggestion, I am meeting with Dr. DeSalvo. And what I would 
like to do, with the committee here listening--well, one other 
thing. Senator Murray and I have formed a bipartisan working 
group on the HELP Committee to identify five or six problems in 
the electronic health records system that we could address 
administratively. In other words, you could do it, or 
legislatively, if we have to, we can do it.
    So what I would like to ask you is will you commit to 
putting on your list of things you would like to get done in 
the year and 9 months that you plan to be here, working with 
us, identifying five or six things that would make this promise 
of electronic health records something that physicians and 
providers look forward to instead of something they endure?
    Secretary Burwell. Yes. After our meeting and our 
conversation, I think we got a working group of staff ready to 
go, and we are committed to do that.
    I think this is extremely important in and of itself, but 
also because of all the things it touches. We are going to talk 
about so many things that touch this. I'm sure I'm going to get 
a question, hopefully, about opioids and heroin. Electronic 
records touch that issue. The precision medicine issues that we 
are talking about, electronic records touch that issue. 
Delivery system reform, creating a system of healthcare 
delivery that has better quality and is more effective and 
efficient, it touches that.
    And so we should focus on it, in and of itself. Where 
healthcare is going and where everything is going in terms of 
our ability to serve the consumer, the patient, in the way we 
need to, this is a core part.
    So I welcome the opportunity and look forward to putting 
the list together and look forward to getting it done. We will 
look at our administrative things, and we want to work with you 
all on what we need legislatively as well. There may be some 
things there.
    Senator Alexander. Great. There is a lot of interest on the 
committee. Senator Cassidy has expressed that. He is a 
physician himself. Other members on the Democratic side have 
expressed that.

                             OVERREGULATION

    And one other area where I think we should work together, 
and we have talked about it, Senator Mikulski and I and Burr 
and Bennet asked some higher education folks to give us a 
report on the cost of overregulation. And they gave us 59 
recommendations about what to do.
    We are putting it together in legislation, and we are going 
to incorporate these ideas as much as we can in the Higher 
Education Act.
    At the same time, the National Academy of Sciences has said 
that principal investigators of federally sponsored research 
projects spend 42 percent of their time on administrative tasks 
instead of research.
    Now, we do a lot of talking here about needing more money 
for research. Taxpayers spend $30 billion a year on research 
and development at colleges and universities. NIH spends about 
$24 billion. Vanderbilt University hired the Boston Consulting 
Group to tell it how much it costs Vanderbilt to comply with 
Federal rules and regulations, and the answer was $150 million 
for 1 year, and a lot of that had to do with research.
    Now that is not all in your department, and it is not all 
in education, but my question is, will you work with us and 
help us work with other agencies to see if we can work with the 
national academies and take that 42 percent down, releasing 
hundreds of millions or maybe billions of dollars, which could 
be used for important research of the kind that all of us hope 
there should be more of.
    Secretary Burwell. Yes, I think it is an important issue. I 
think we can make progress. When I was at the Bill and Melinda 
Gates Foundation and we were doing grant-making, our grantees 
would always ask us to pay the administrative level that the 
Federal Government would.
    So I believe we need to work on it. We need to work on it 
from our end in the Federal Government. But across, it will 
help even beyond the work that we do.
    And I think for some of these things, we need to figure out 
where we are willing to take certain risks. Some of the 
administrative costs have to do with very important things, 
like tracking conferences and provisions that are put in. So I 
think this is a place that is ripe for us to have quality 
conversations about what are the things we can do to reduce 
some of that burden. And we want to make sure we are all clear 
what it means when we do the changes that we do.
    So I welcome that chance, and I know our NIH colleagues, 
there are a number of things that are already on their list 
that they would like to talk about.
    Senator Alexander. Thank you, Madam Secretary.
    Thanks, Mr. Chairman.

                                 LIHEAP

    Senator Blunt. Senator Reed.
    Senator Reed. Thank you, Mr. Chairman.
    And thank you, Madam Secretary, for your testimony and for 
your great leadership.
    Let me focus on the topic of LIHEAP. Senator Collins and I 
have been, as you know, for years, committed to ensuring we 
have adequate resources. I am pleased to see your budget 
request is a slight increase from previous years, but still 
$200 million below the previous authorization and 
appropriation.
    So what can we do to get LIHEAP further funded?
    With weather patterns as they are, it is not just cold in 
the Northeast and families dealing with that. It is 
increasingly hot summers where air-conditioning is essential 
for people in the Southeast, Southwest, and the West Coast.
    So can you help us?
    Secretary Burwell. In the budget proposal, what we did was 
propose the base level of LIHEAP at last year's level. We also 
proposed a contingency fund, and this actually gets to the 
issue of the variability, and what LIHEAP is about, and that we 
are having these huge changes.
    What we were trying to do is create a fiscally responsible 
way to respond to the type of increasingly erratic weather that 
we are seeing, and the contingency fund needs to be put in the 
budget, so that we have the contingency fund. But it would 
allow us to have some flexibility.
    So funding at the base level, but then add a contingency 
fund that could help us. So that was our approach to working to 
get additional LIHEAP funding.
    Senator Reed. I commend you for, again, the increase. I 
think we have to do more. Senator Collins and I both--I will 
speak for her I think--look forward to work with you on this.
    There is a related issue, and that is you have 
discretionary authority to move aside about 1 percent of 
appropriated funds and you consistently do that with LIHEAP. 
Today, there is about $34 million of LIHEAP funding that has 
not been spent. And there is, certainly, the need out there. 
Can you work to release those funds or commit them to make sure 
they are committed to LIHEAP?
    Secretary Burwell. I think at this point in time, we are 
doing the final review to understand if and when those funds 
will go. So we will work with you on that issue. We are 99 
percent there with $3.3 billion spent. And the $34 million is 
the outstanding amount at this point.

                    SECTION 317 IMMUNIZATION PROGRAM

    Senator Reed. Thank you very much, Madam Secretary.
    Let me turn quickly to another topic, and that is the CDC 
Section 317 immunization program. It buys the vaccine for many 
middle- and low-income families. It provides the structure for 
vaccination, which is to critical public health--in fact, I'm 
going to argue one of the most critical public health 
initiatives that we have taken in the history of public health.
    It is somewhat disappointing that your budget is going to 
cut this program by $50 million next year, and particularly 
disconcerting because we are seeing the outbreak of some 
contagions we thought were--in my youth, like measles. And this 
Section 317 is also used to track that and respond to that.
    So looking at all these issues, why are we cutting this 
program?
    Secretary Burwell. Like you, we agree and are very 
concerned about the vaccination issue, especially in the 
context of the measles outbreak that we have seen.
    With regard to 317, there is also the additional 
complementary program. This is the children's vaccine fund. 
When you combine the two of those programs together, there is a 
net increase of $58 million in the budget overall.
    With regard to 317, as we are implementing the Affordable 
Care Act, parts of 317 were used for those that were 
underinsured. And because when the ACA was passed, it was 
actually required that all plans do no cost-sharing.
    So when I take my child in for the wellness visit, that 
vaccination doesn't have a co-pay.
    Because of that reduction, the 317 money for vaccine 
purchase is being reduced because we have people who are now in 
a fully insured space.
    With regard to the funding in 317 that does the kinds of 
things that are very important that you mentioned, that is 
something we are doing more and more of through the CDC; none 
of those funds were cut as part of this.
    Senator Reed. You are doing analysis to ensure that there 
is no gap, that, in fact, children are getting the vaccines 
through the ACA mechanism?
    Secretary Burwell. The problem that Senator Murray raised 
with regard to contraception we have not seen with regard to 
vaccination, which is that people are in any way not covering 
that.
    If that is something people are hearing about, please let 
us know. It is when we hear that we go back out with the 
guidance. We have not heard that from anyone at this point. 
That is the part that seems to be being implemented correctly. 
But if you are hearing something different, we want to know, 
because, obviously, this is an extremely important issue.
    Yesterday, I did the formal swearing-in of the surgeon 
general. And as you all probably know, measles is one of the 
issues that he has been deeply focused on, including the public 
service announcement with Elmo. We are trying to do everything 
we can, work with the States directly, epidemiologically, 
educate, anything we can.
    Senator Reed. I think Elmo is a good point to cease 
questioning. Thank you.
    Senator Blunt. I agree.
    Secretary Burwell. My children now understand my job. When 
I took home the picture of me with Elmo, that they appreciated.
    Senator Blunt. That is the moment they knew you arrived.
    Secretary Burwell. Yes.

                      UNACCOMPANIED ALIEN CHILDREN

    Senator Blunt. Senator Cassidy.
    Senator Cassidy. Secretary Burwell, how are you?
    Secretary Burwell. Good morning, Doctor.
    Senator Cassidy. A couple of things. First, you had 
mentioned--this question has bugged me for a year. So when you 
mentioned the effort that CMS had made for those unaccompanied 
children coming to the board, when I was in the House last 
year, there was a roundtable, an oversight hearing.
    Now as I recall, CMS had $800 million in the regular budget 
last year to care for the expected surge of unaccompanied 
children. And there was a physician there, and she had the 
Public Health Service uniform on. And I was a little critical 
because the response had been so poor. And she said, I am the 
first doctor, and I was just hired 2 weeks ago, and this is 
like July.
    Now I don't expect you to have the answer as to how that 
$800 million now with you, but expect a question for the 
record. CMS or HHS had $800 million, and the first doctor was 
hired in the middle of the summer when they had requested a 
bump-up in anticipation of a surge of unaccompanied children.
    So just to make that point, and I would like to follow up, 
and you can follow with that, because, again, I don't expect 
you to have that. But nonetheless, when you mentioned it, oh my 
gosh, it just popped up. It has bugged me ever since.
    She was a dedicated physician, but she had been hired as 
the first physician. She said there were two or three nurses 
working on it, but never a physician, and only two or three 
nurses to handle the whole program. No offense against the 
nurses. It was just so few of them.

                                 ICD-10

    Secondly, you had mentioned the ICD-10 effects. I am going 
to speak for that physician who is in a smaller practice. The 
big hospital chains are of course ready, but what I am reading 
here from athenahealth, but quoting CMS, CMS estimates that in 
the early stages of implementation, denial rates will rise by 
100 percent to 200 percent, and days in accounts receivable 
will grow from 20 percent to 40 percent. It goes on to explain 
why.
    So I will just say, according to your own Web site, that 
urologist in South Louisiana, who is in a one- or two-person 
practice, she cannot afford to have denials go from 100 percent 
to 200 percent and her AR growing by 20 percent to 40 percent.
    Personally, I think the reasonable thing to do would be to 
delay the penalty phase for 2 years as people transition, 
because it is that doc who is just struggling to see however 
many patients she has a day and also comply with EHR, who 
suddenly is going to have her denials grow by 100 percent to 
200 percent. Not because she's not doing it right, but because 
the system has changed.
    Unless we are sympathetic, we are going to drive her out of 
practice. And that is what is happening.

                          AFFORDABLE CARE ACT

    I also will put that plug in just as a kind of an esprit de 
corps for all those physicians who right now just feel--now 
this is something that perhaps you can address.
    In February 2013, the CBO projected the per person cost of 
Medicaid for just that portion getting acute care, for example, 
the expansion population under the Affordable Care Act, would 
be $2,500 in 2014, only including estimates for the fully 
eligible.
    Last month, the CBO projected an average per person cost of 
Medicaid for $3,460, including both partial eligible and fully 
eligible. Now this is a jump of $1,000 per beneficiary over the 
entire Nation, which is almost a 40 percent increase.
    What is going on with Medicaid? We will disagree, but the 
Affordable Care Act is unaffordable for the taxpayer, if from 
year to year we have had a 40 percent jump in per person 
Medicaid costs.
    Secretary Burwell. So I will want to go look at exactly 
what that CBO references is, because across the Affordable Care 
Act in the system, Medicaid, as you probably know, is generally 
the least expensive option, in terms of service and care for 
individuals. So I am surprised by that CBO number, because as 
you and I had the chance to discuss in terms of the net and 
overall costs, we have seen that not happening.
    So I apologize, I have not seen that particular number, and 
it is not indicative of what my understanding of what the cost 
curve is.
    Senator Cassidy. Sounds great.
    Then one more thing let me just squeeze in, again, because 
you started off I think extolling the Affordable Care Act. I 
will point out that, apparently, only 2 percent of those with 
400 percent or above income--i.e., not eligible for subsidies--
only 2 percent of those eligible have signed up for insurance 
through the exchanges.
    So the middle class is getting hosed by premiums, which 
have increased dramatically, and we are just going to leave the 
middle class behind when it comes to affordable health 
insurance.
    Secretary Burwell. So with regard to premiums in the 
employer-based market----
    Senator Cassidy. No, this is in the exchanges. Only 2 
percent of those eligible for insurance through the exchanges 
have signed up for insurance.
    Secretary Burwell. I think with regard to the number that 
we have seen in terms of those eligible to receive insurance 
through the marketplace, as we have talked about, it is about 
16.4 million people is the reduction, which is the largest 
reduction we have seen as a Nation in decades.
    Senator Cassidy. We can debate that, because, again, as we 
talked about, CBO reduced their baseline of those insured. And 
the numbers I have looked at, is that most of those newly 
insured have signed up through Medicaid, not through the 
exchanges.
    Secretary Burwell. CBO reduced their baseline of those 
uninsured.
    Senator Cassidy. Correct.
    Secretary Burwell. CBO recently reduced the estimated cost 
of the Affordable Care Act by approximately $300 billion.
    Senator Cassidy. Just for truth in advertising, that is 
because States didn't do the Medicaid expansion.
    Secretary Burwell. It was a combination.
    Senator Cassidy. And not as many people----
    Secretary Burwell. States didn't do the expansion, costs of 
healthcare cost increases were much smaller, and premiums were 
much lower than they had expected in their original. Fewer 
people moved from employer-based care to the marketplace than 
what was in CBO's original.
    It was the combination of those three things that had the 
reduction. And CBO went from a number of about 55 million being 
uninsured--and that is total; that is not eligible for the 
marketplace--to 52 million. So what CBO did was actually reduce 
the number and, therefore, the percentage of uninsured that we 
now have, did.
    So with regard to the question of number of people in the 
marketplace, we want that to continue to go up. We want to do 
everything we can. I think you saw we worked hard to have an 
open enrollment that served the consumer. It actually is 
important for us to have the conversation, so I welcome it.
    Senator Cassidy. Yes.
    Secretary Burwell. So we were trying to serve the consumer. 
And I think we saw and continue to see growth.
    Can it be more? Can it be better? We would like to do that, 
and we would like to work on the ways that we can make more of 
those consumers come in and find that affordability.
    Having traveled around the country and met the woman who 
said to me, you know how you treat MS? This is a working woman, 
three children. You get sick enough until you go to the 
emergency room, and they'll treat you. And she said, now I have 
a card, and now I'm going to learn how to treat MS.
    Senator Cassidy. We are 3 minutes over, but I will finish 
by the woman I spoke to who says I'm 56-years-old.
    Senator Blunt. We actually are 3 minutes over.
    Senator Cassidy. And I am paying $500 more a month for 
insurance, and I don't need what I'm getting with a $6,000 
deductible.

                               TELEHEALTH

    Senator Blunt. Mr. Schatz.
    Senator Schatz. Thank you, Mr. Chairman.
    Thank you, Secretary Burwell.
    I have a question about telehealth. I am a big believer in 
telehealth. I think the VA has done a lot of good work in this 
space. The DOD has done good work. Private healthcare providers 
are really expanding their services as a way to improve 
clinical outcomes. It's also a way to save money in systems.
    And I just want to know what Medicare, in particular, is 
doing, what you think you can do additionally within the 
confines of 1834(m) and whatever kind of statutory restrictions 
you may have.
    Could you just sort of divide the question into those two 
categories: where you think the law really needs to be changed 
and you're stuck, and what you think you could be doing within 
the confines of the statute that you are not doing yet.
    Secretary Burwell. I think the places where we can do more 
are in our innovation center. In the funding we receive for the 
innovation, and that was part of the Affordable Care Act, there 
we are seeing and doing a number of innovative projects 
including telehealth. So that is one place where we are acting.
    Several of the things that we have funded that include 
telehealth components that we think are important. And I think 
you all know the statutory requirements with regard to it 
meeting success are very high, so it will take time and 
measurement to get there and prove that. But we want to work to 
do that, hit those measures, because that's when you can scale 
them.
    We have to be able to show, quality and cost. So we have to 
get there and do that.
    The other place, in terms of the authorities we currently 
have, have to do with some of the ACO work we are doing, 
Pioneer ACOs and others, accountable care organizations.
    Actually, we just recently put out a sort of a version 2.0 
and telemedicine was increased in that.
    With regard to statutory issues, I think we need to have 
conversations about places we can talk about where there might 
be changes that would free us to do more telehealth. And that 
is on the Medicaid payment side.
    Senator Schatz. Right. Okay, so let's do two things. First 
of all, let's work together, and I know Senator Wicker as the 
chairman of the subcommittee on telecommunications, had a 
really good bipartisan hearing on the potential for telehealth. 
I think there were 17 members of the subcommittee who attended. 
There was broad and deep enthusiasm on a bipartisan basis.
    I want to work with him. I know a lot of other members are 
anxious to get going in that space. And I think he's going to 
work on legislation to introduce in this Congress in that 
space.
    So first of all, we have to work on whatever changes in the 
law are necessary. I also would encourage you, because during 
that hearing, the national organization for telehealth, I think 
that is what they are called, but in any case, the national 
organization that advocates in this space thinks that you can 
be doing more even within the constraints of 1834(m). So I know 
you did this next gen ACO, but some my staff and others are 
saying you could move a little quicker in store and forward, 
and some other areas.
    So I am anxious. I know you believe in this. I know the 
administration believes in this. And I know there are other 
executive branch agencies that are moving faster.
    Now some of that is because of the law itself. But some of 
it may not be. So if you could just check with your staff to 
see that we are doing absolutely everything that we can 
possibly be doing to advance the ball on this? You are one of 
the biggest payers around.
    And so on the telecom subcommittee, a lot of the questions 
were logistical and clinical, and setting up markets and the 
rest of it. And in my view, a lot of those problems downstream 
get solved if the payer comes to the table. That all gets 
settled, because there will be a built-in market. I think you 
can make some additional incremental progress, as we work on 
legislation together.
    Secretary Burwell. That's great, because I think you know 
the payment has to do with, is it something that exists? Or 
does it have a certain proof point?
    Those are the places where I think there is room to see if 
we can push our authorities. If you all have ideas, we welcome 
that.
    Senator Schatz. Thank you very much.

                        HRSA BLACK LUNG CLINICS

    Senator Blunt. Senator Capito.
    Senator Capito. Thank you, Mr. Chairman.
    And if it's not lost on anybody on this committee to know 
that we are both daughters of West Virginia, and I'm very proud 
of the Secretary. She does a great job representing our State 
and our Nation.
    Secretary Burwell. Thank you.
    Senator Capito. So it is an honor for me to be here with 
you for the first hearing.
    The question I had specifically, and I mentioned this the 
other day when we were talking, is about the Black Lung 
clinics. HRSA made a change in their allocation to cap it at 
$900,000, which actually costs West Virginia some Federal 
dollars, trying to make sure that we meet the challenge of 
ridding ourselves and treating Black Lung disease, which, 
unfortunately, we have.
    What is the rationale for this per grantee cap? Is this 
going to continue? We were able to sort of recover a little bit 
through another grant process, but I am concerned about this 
because of the deep need that we have in our home State.
    Secretary Burwell. Following our conversation, I went and 
had some conversations about why the changes were made. And the 
changes were made in the program to make sure--we were 
fulfilling the statutory obligations with regard to the quality 
of grant-making. I think that was a very large portion.
    There were two elements. One, the question of making sure 
we are getting to quality, but the second issue was getting 
closer to the communities. When all of the money was being 
funneled through State grantees, there were also other grantees 
in States that actually were serving communities as well.
    I went to look at our State to see what had happened. And I 
think in the year before, the State, received a grant of $1.4 
million. And in the end, what happened was that two grantees, 
one was the State and one was another player, came to one, too. 
So it was a $200,000 reduction, in terms of what the State 
received.
    But the objectives were to try and improve quality and get 
some grantees that are closer to the local communities.
    Senator Capito. So is the interpretation that I am making, 
that the $900,000 cap is just the cap that would go to the 
actual State government, and if there are other grantees, you 
could apply through this?
    Secretary Burwell. That is right.
    Senator Capito. Okay.
    Secretary Burwell. And in West Virginia, we did. We 
actually were very fortunate. Actually, someone also raised 
this last year with me, and I had actually asked, could another 
grantee come forward in the State.
    Senator Capito. Okay. Because I mean, I think the money 
needs to flow to the need, obviously. And the quality issue I 
understand.
    Secretary Burwell. I did follow up on that issue, too. I 
did ask them about the question of need, because being from 
West Virginia, I argued that everything, from our type of coal 
to the population that we have, would be greater need.
    Senator Capito. Right.
    Secretary Burwell. I think there is difficulty in 
measurement, and we do need to work and get people to a 
standard where they are able to measure these things, so we can 
make decisions better based on that.
    Senator Capito. Sounds good. Thank you. And we will be 
following up with you on that.
    Secretary Burwell. Yes. And that's a place where we may 
need some help, the measurement.

                            OPIOID ADDICTION

    Senator Capito. Okay. You mentioned opioid addiction, and 
what you are doing in that area.
    Again, all across America, but we seem to be having a 
difficult problem with illegal prescription drug abuse and 
heroin, the rise in heroin, and poisonings, and desperate 
population.
    Help me out here. How can we stop this? I mean, what are 
you doing in the department?
    Secretary Burwell. When I arrived last June, this was one 
of the first things that I asked the team to come together on.
    There were many things going on in the Department and we 
have made that into a consolidated strategy with three 
priorities, because we have a short period of time and we need 
to be focused. We need to be focused with you all, the 
Congress. We need to be focused with Governors.
    It has three basic elements to it. The first is 
prescribing. That is where much of this starts. That is the 
only one that addresses prescription opioids and not heroin. 
The other two elements address both.
    We need to get to a better place, in terms of prescribing. 
Overprescription is occurring, and that is driving a large part 
of it. We need to make sure doctors have the right guidance. 
The head of the AMA was speaking with me about this issue at 
the SGR event, in terms of they need the right guidance. We 
need to work on that.
    But prescribing is number one.
    Number two is access to naloxone. That is an important part 
of the budget conversation we're having right now, because we 
need to give the States the money so they can access the 
naloxone.
    Senator Capito. Our State just passed a State law to allow 
them to carry that.
    Secretary Burwell. West Virginia is good. Massachusetts is 
as well. I'm doing an event next week with Governor Baker, the 
new Republican Governor in Massachusetts who has made this a 
big priority, even in his state of the State. We are going to 
do an event together. They have good things going on there.
    The third thing has to do with medicated assisted 
treatment. Because, sadly, for both heroin and opioids, we have 
so many people addicted that we are going to have to use 
medication as part of the treatment.
    Those are priorities that I think we all need to work on 
together.
    With regard to our work with Congress, it is about funding, 
in terms of the conversation we are currently having. It is 
also about something called buprenorphine, which is also part 
of treatment, and how we prescribe and how we control 
prescribing.
    But at this point in time, there is general agreement it is 
a little too controlled, but the changes we need to make I 
think we need to make in conjunction with Congress.
    The other thing is working with the States and making sure 
they have the prescription drug monitoring plans--PDMPs is what 
they are referred to--put in place and are strong.
    Eventually, we need to make sure those plans are going 
across States. To us in West Virginia, the border with Kentucky 
is porous. And if we can't know what that person in Pike County 
is prescribing, in Mingo County, people are going across.
    So those are the kinds of steps we need to take.
    Senator Capito. Okay, good. Thank you.
    Senator Blunt. Thank you.
    Senator Baldwin.

                            OPIOID ADDICTION

    Senator Baldwin. Thank you, Mr. Chairman and Ranking 
Member.
    I am going to follow on Senator Capito's questions in just 
a moment. But before I do, I want to thank you, Secretary 
Burwell, for being here and sharing with the committee, and I 
am hopeful that we can find relief from the Budget Control Act 
to allow this subcommittee to draft a bill that provides the 
funding that HHS needs for its critical programs and to carry 
out its mission and serve the very people that we all represent 
in our home States.
    And as another side note, as someone who was raised by an 
NIH-funded scientist, my grandfather, I am certainly a strong 
supporter of our research and NIH budget. But in particular, 
knowing the impact that our scarce funding has had on young 
researchers, I am especially concerned that the Budget Control 
Act continues to put our next generation of researchers at 
risk.
    But as I said, I want to focus in on the opioid 
prescription initiatives that are in your budget. This is an 
issue that obviously impacts many of our States, I would dare 
say all of our States.
    And so I am interested in hearing a little bit more about 
the CDC's plan to develop opioid-prescribing guidelines. In 
particular, I want to ask some specific questions about that.
    Number one, we have seen in Wisconsin some particularly 
tragic cases involving our VA system, a number of tragic deaths 
of patients who were treated at our VA center in Tomah.
    So part of my question is, will these guidelines be 
applicable to systems like the VA system? And then secondly, 
guidelines are just that, guidelines. They are not mandates. 
And so we have had challenges when best practice and, when 
guidelines have been articulated before, in getting the 
widespread adoption of those in our medical and prescribing 
community. Please speak to that, too.
    Secretary Burwell. So with regard to the guidelines, one of 
the things I think people feel is that they do need more 
clarity, because there are important issues of pain that need 
to be treated, and treated with the types of drugs we are 
talking about.
    So we don't want to deny those who depend on these drugs 
for their daily living. CDC will work with FDA, with NIH, with 
all the other parts to provide those guidelines.
    With regard to the issue that you just articulated with 
guidelines, this is another space that I actually think we may 
need to have a conversation about potential legislative help. 
And that has to do with training, because even if we put the 
guidelines out, whether or not those existing physicians, and 
even those coming through, will be trained in these mechanisms 
and trained in these guidelines, is a question that I think is 
an extremely important one.
    And so how that and where that occurs may be a conversation 
that we need to continue. That is how we thought about this 
strategy. That, actually, is a very specific issue that is on 
our list, to continue to have a dialogue and conversation with 
you all about.
    Senator Baldwin. I would welcome that follow-up, because 
the tragedies we have seen in our States, that I have seen in 
my own State, deserve a response of the utmost seriousness. In 
fact, I think we are coming very late to this issue.
    Your testimony, Secretary Burwell, highlights that, in 
2009, total drug overdoses overtook every other cause of injury 
deaths in the United States. And we have yet to implement a 
comprehensive strategy.
    So in addition to working together on future perhaps 
legislative measures, what I want to ask you is, how will the 
administration's proposed initiatives that address this growing 
nationwide emergency be impacted if your budget request is not 
funded?
    Secretary Burwell. It will be extremely important. The 
funding is very important to the States. That is one of the 
most important parts of this, because it is implemented on the 
ground. So the funding goes to SAMHSA and CDC. Those are the 
places where the money is going directly to the States, so 
having that money available for training and the purchase and 
use of naloxone.
    States are providing the legislation so that more and more 
people can use it, because there was a question of what type of 
EMT did you have to be to use it in a number of States. But 
West Virginia, Massachusetts, and Kentucky, are places making 
good progress. But even when they make that progress, there are 
funding issues. So it becomes very important that we make 
progress this year on these issues.
    I also think it is important to reflect that this is done 
completely in coordination with ONDCP, the Office of National 
Drug Control Policy in the White House. That is our policy 
counsel for these issues, to make sure that we are coordinated 
at HHS, DHS, and Department of Justice. It is mainly us and the 
Department of Justice that are the two places that interact, 
because it is mainly law enforcement officials who are the 
people who need to know how to apply naloxone. They are the 
people on the scene when there is a drug overdose.
    So we need to make sure we are closely tied, and the funds 
are a part of that.
    Senator Blunt. On your thoughts about legislative help 
there for connecting these people and places and spaces with 
what they need to know, do you think you need more authorizing 
language? Or is this the kind of help you've asked for in the 
appropriating budget?
    Secretary Burwell. It's not just money. I think it is about 
how people are willing to implement the guidelines, and make 
sure that people are trained. The question of continuing 
medical education and how this touches upon that are the kinds 
of questions we need to talk about.
    I think the AMA and others are thinking through this. But I 
think it is an important enough issue that we as a Nation at 
this particular point in time need to make sure that if we have 
the guidelines, that people are being educated.
    Senator Blunt. Chairman Cochran.

                        317 IMMUNIZATION PROGRAM

    Senator Cochran. Mr. Chairman, even though I know this 
question has already been asked by one of our members, it 
relates to the immunization program.
    Funds are provided to all States to help provide vaccines 
to those who are not able to buy them, because of their own 
difficult economic challenges. And there is a majority of funds 
that are available for childhood vaccinations. And our State 
has to win the prize as the highest childhood vaccination rate 
in the country. We are proud of that, because a lot of people 
spend a lot of time and effort in making that possible.
    But it all depends on funding from the program. So in 
looking at the budget request, we are disturbed that over $50 
million in advance funding is recommended. To reduce funding 
for that amount would be devastating, we think, to the 
Affordable Care Act.
    What is your reaction to that? Do you have any thoughts 
about what we can do?
    Secretary Burwell. What we have tried to do is design a 
vaccine budget that included both the children's vaccine and 
immunization, which actually increased close to $70 million. 
The increases in the children's vaccine fund that we made were 
greater than the decreases in 317. So net-net, it was about a 
$50 million increase.
    What we were trying to do is make sure the places where we 
did do decreases were for funding for those who were 
underinsured. And those who were underinsured, because of the 
Affordable Care Act, that is not occurring, because it is 
covered.
    If you have insurance now, there isn't an uninsurance issue 
in that you would have to pay a co-pay for your child's 
vaccination. You no longer will have to do that.
    So that is where we were. The cost of the vaccines we were 
purchasing for use in the facilities that you are talking 
about, that is what has been reduced. That is because we 
believe, because of the Affordable Care Act, that is being 
taken care of through private insurance now.
    So we have tried to implement a policy that actually 
increases overall vaccination funding but decreases it in a 
place that, because of the Affordable Care Act, those people 
who were underinsured, had insurance but it didn't pay for 
this, it now does. That is the objective of the policy.
    Senator Cochran. Okay. Thank you.
    Thanks, Mr. Chairman.
    Senator Blunt. Thank you, Mr. Chairman.
    Senator Merkley.

                      AFFORDABLE CARE ACT COVERAGE

    Senator Merkley. Thank you very much, Mr. Chair.
    Thank you, Madam Secretary, for your testimony.
    As I read your testimony, the number that was higher than I 
had seen before was that 16.4 million Americans who were 
previously uninsured have now gained health insurance coverage 
through the different facets of the ACA.
    Am I interpreting that correctly?
    Secretary Burwell. Because I always want to be careful with 
numbers, we think the vast majority of that includes all ACA 
provisions. But I think the economy has recovered and so some 
of those people may be people who gained insurance because they 
have jobs now that have insurance.
    So I want to be clear. I think the vast majority gained 
coverage because of the ACA, and we know that because of the 
marketplace. But a portion of that could be from something that 
I think is a very positive thing, which is people who have 
employer-based care.
    Senator Merkley. So you go on to have numbers that 11.2 
million additional individuals are now enrolled through 
Medicaid and CHIP. So I assume the large balance, or roughly 5 
million of the 11 million who are on the exchange, are folks 
who previously didn't have insurance, in ballpark numbers?
    Secretary Burwell. Yes. Those have to be derived, because 
we don't ask anyone when they come in, because there are no 
pre-existing conditions.
    Senator Merkley. Yes. Is that roughly the right ballpark of 
your estimates?
    Secretary Burwell. I am not sure. I don't think we have put 
out a number of exactly the number in the marketplace who were 
uninsured.
    Senator Merkley. Okay, let me continue then.
    I was very struck by the statement in the testimony that 
eight of 10 of those who go to the exchange after tax credits 
get health insurance for less than $100 per month.
    Secretary Burwell. That is correct.
    Senator Merkley. So that is out of that 11 million, 80 
percent of those.
    Secretary Burwell. That's right.
    Senator Merkley. Well, it has been a huge change in the 
uninsured rate in Oregon. Our hospitals are seeing a dramatic 
drop in the coverage of the uninsured, which gives them more 
dollars to provide healthcare, and stops the transition in 
which folks who have insurance had to pay through their rates 
for folks who do not have insurance, if you will, the 
uncompensated care.

                              E-CIGARETTES

    I want to turn to another area I have concern about. A year 
ago, when Commissioner Hamburg was testifying, I raised the 
issue here of concern over the explosion in the use of e-
cigarettes or vaping. These are the electronic devices that 
vaporize liquid nicotine. It comes in little bottles like this. 
And I showed these same two bottles, JJuice Scooby Snacks 
labeled, and JJuice Gummie Bear.
    This now has changed dramatically in a single year. We have 
a new report from the CDC, and it is titled, ``E-Cigarette Use 
Triples Among Middle and High School Students in Just 1 year.'' 
It goes on to detail that for high schoolers, it has gone from 
4.5 percent to 13.4 percent. Middle schoolers, from 1.1 percent 
to 3.9 percent, so almost a quadrupling for middle school.
    All the CDC studies show that nicotine for adolescent 
brains is a very bad combination. Thus, it is very important 
that we regulate this. Back in 2009, Congress gave power to the 
FDA to regulate flavors and basically all aspects of tobacco 
products.
    So now we are here 6 years later, and we don't have those 
regulations yet. And I very much appreciated your call to 
update me on the process.
    The process goes from FDA, and then it goes to OMB. And has 
that transition occurred yet? Is OMB now reviewing? Has FDA 
shipped its draft final regulation to OMB?
    Secretary Burwell. We are still reviewing the comments at 
our end, at HHS.
    Senator Merkley. At HHS. So it has yet to go to the final 
review within OMB?
    Secretary Burwell. That is correct.
    Senator Merkley. Or is that simultaneous?
    Secretary Burwell. No, we complete the process of the 
review.
    Senator Merkley. You know I was going to ask you about 
this, but when do you anticipate that will be completed?
    Secretary Burwell. So the question is the overall process 
of the rulemaking. I think everyone knows that we have a notice 
of proposed rulemaking. We have a rulemaking that we are in the 
middle of receiving comments on.
    It is our hope that, at some point this summer, we will get 
to a final stage.
    Senator Merkley. Well, I hope that it is more than hope. I 
hope it is a reality. I appreciate your personal efforts to 
accelerate this process.
    But I still am deeply disturbed by the fact that this has 
taken this long. Had this taken 2 years less, 4 years instead 
of 6 years, and I don't think anybody thought it needed to take 
4 years, then we would have many thousands of high school and 
middle school students who are not being basically brought into 
the nicotine addiction world through these flavors designed 
specifically to appeal to children.
    I mean, you have Chocolate and you have Strawberry and you 
have Gummie Bear and you have Scooby-Doo.
    And the statistics show that 90 percent of smokers first 
began smoking, and I am including vaping in this, as teens. 
Three out of four teen smokers continue smoking as adults.
    In other words, the industry understands that it is in 
childhood, in the teenage years, that you must secure the 
addiction, which then has huge consequences for the quality-of-
life of the next generation and huge consequences for the cost 
of our healthcare system.
    So this is one of those opportunities to make a dramatic 
improvement that makes a tremendous amount of sense from every 
direction. And for every month of delay, it is additional 
Americans who are damaged.
    And it's not just in the smoking. It is also in the 
poisonings. The poisonings have exploded in the space of time 
since 2011 until now. It's a 14-fold increase in the 
poisonings, because these little things, jars look very 
appealing. They look very appealing, and they are labeled juice 
and they are called Gummie Bear. It must be something good to 
drink.
    And do you consider it irresponsible that people are making 
these things and not putting them in childproof bottles?
    Secretary Burwell. With regard to that, I think the 
question of how everything will be regulated once we get to the 
deeming, I think those are the questions we are going to have 
to work to answer and answer quickly.
    Senator Blunt. Time is up.
    Senator Merkley. Am I over time?
    Senator Blunt. Yes, you are.
    Senator Merkley. Okay. Thank you very much.
    Senator Blunt. Senator Moran.
    Secretary Burwell. Thank you.

                       EARLY CHILDHOOD EDUCATION

    Senator Moran. Mr. Chairman, thank you. Congratulations to 
you and Senator Murray for your leadership on this 
subcommittee.
    And, Secretary Burwell, welcome. Thank you for reaching out 
to me this week, to see if we could have a conversation on the 
phone. It's my fault it didn't happen.
    But I am very appreciative of the efforts that you make to 
stay in touch and have conversations.
    I think I will have time for a couple of questions. Let me 
ask first an early childhood education question.
    This committee last year allocated $500 million to be used 
to expand access to infant-toddler services through Early Head 
Start. And the goal was to expand childcare partnerships. 
Please tell me about implementation and particularly assure me 
that rural communities where even licensed childcare is a rare 
commodity, that they are being considered appropriately for 
those services.
    Secretary Burwell. We have worked toward implementation, 
and I think because the program had both Early Head Start and 
childcare partnerships, that expanded our ability to serve in 
communities where various types of care would be provided.
    We want to make sure we are meeting standards, that are 
working.
    The issue of rural America and these issues of rural access 
to these types of programs is something I think you probably 
know is deeply important to me, as someone who participated in 
Head Start many, many years ago. I understand the limited 
access that some have to quality early education.
    So they're issues that we are working toward. If there are 
things you are hearing that aren't consistent with that, could 
you please make sure we know? We haven't heard this issue, so 
if there is something you have heard from your State, I really 
would like to know about it.
    Senator Moran. What is the status of implementation?
    Secretary Burwell. Grant-making is occurring. I would have 
to check on exactly what stage of the grant-making we are in. I 
can remember the point at which the announcements went out to 
solicit the grants, but I'm not sure exactly where we are in 
the process. But we can get back to you on that.
    Senator Moran. I would welcome that.
    [The information follows:]

    All of the Early Head Start-Child Care Partnership grants were 
awarded by March, 2015.
    The Administration for Children and Families categorized grantees 
as serving rural areas using the Rural-Urban Commuting Area (RUCA) 
codes established by USDA and approximated by the University of North 
Dakota. According to the Census Bureau, urban cities and towns have 
populations greater than 2,500. RUCA defines rural as an area that does 
not fall under the Census Bureau urban category.
    Each grantee funded under the new EHS-CC grants program must report 
a main street address. Our review indicates that approximately 90 
percent of grantees' main offices are located in an urban zip code and 
10 percent of grantees' main offices are located in rural zip codes. We 
believe that the number of grantees serving rural areas is actually 
higher because some grantees with main offices located in an urban area 
serve rural communities, as well. In addition, some grantees are still 
finalizing the sites of their EHS-CC partners. Once grantees solidify 
their partnerships and are operational, we will be able to provide 
urban and rural classifications based on the service area of the 
grantees. The percentage of EHS-CC grantees in rural areas is similar 
to the percentage of Head Start grantees in rural areas.

                           DIETARY GUIDELINES

    Senator Moran. Let me change topics now and talk to you 
about dietary guidelines. You and Secretary Vilsack, Secretary 
of Agriculture Vilsack, are charged with developing dietary 
guidelines. And in that process by which you develop those 
guidelines, you have an advisory committee, the Dietary 
Guidelines Advisory Committee.
    They have issued a report, and at least to many of us, it 
is a very controversial report, because it includes, in their 
recommendations, and they admit they are taking into account 
topics outside nutrition and diet, and specifically considering 
environmental sustainability. So dietary guidelines, which in 
and of themselves are hard to determine what the right answers 
are, at least by your advisory committee, is now being expanded 
to include consideration of environmental sustainability, 
contrary to the statutory framework by which you and Secretary 
Vilsack are instructed to develop the guidelines.
    I have had conversations with Secretary Vilsack in person 
in my office, as well as in the hearing in front of the 
Appropriations Subcommittee on Agriculture, in which he 
indicated to me that he will color within the lines. By that, I 
assume he's assuring me that he is going to abide by the 
statutory framework for those guidelines.
    I have also asked him if he's had conversations with you 
about this topic and what interface is occurring. And my 
impression is, at this point, that is probably not occurring, 
at least at the secretarial level.
    So my question to you is the same as to the Department of 
Agriculture. I want to make certain that you agree with the 
sentiment expressed by the Secretary of Agriculture. I want you 
to assure me that you intend to, in developing the final 
guidelines, that you will disregard areas that are outside your 
instructions in developing the dietary guidelines, that you 
will stay true to the issues of diet and nutritional science, 
and not expand the dietary guidelines to something beyond its 
intended scope.
    Secretary Burwell. Actually, the Secretary and I have 
spoken. It was about an issue he took up with me, and then I 
think I received your letter after. We received two different 
letters.
    And we extended the period of comment, because right now, 
we are in a period where it has been put out.
    Senator Moran. Thank you for that.
    Secretary Burwell. So we have extended that.
    I have talked to the Secretary. The first issue that faced 
us, the process issue, he and I had a chance to talk about it, 
agree, and very quickly, extend it by 30 days, for the reasons 
you have stated. We want to see what the comments are, and we 
want to see what we get back.
    When the process comes to HHS, we receive what the advisory 
committee does. But we will have the full spectrum of our 
health participants, as well as the surgeon general and the 
Office of the Assistant Secretary of Health, be part of the 
conversation as we develop with USDA what will be the final.
    With any issue, I will always want to abide by the statute. 
And as we work to implement that, that is what we will do.
    Senator Moran. I gave you too easy of an out, because, of 
course, you would say you want to abide by the statute that 
governs your actions.
    So the follow-up question would be, do you share my view or 
the view, let me say it this way, do you share the view that 
the dietary guidelines are to be developed around dietary and 
nutritional science, and nothing more?
    Secretary Burwell. I have to be honest and say I have not 
reviewed the statute closely enough to be able to answer that 
question, in the specific way that you have posed it.
    As I think I was indicating, the people that are involved, 
in terms of our issues around science and health, are FDA, and 
NIH. That is where our sweet spot is. Those are the things that 
are probably where we have the most----
    Senator Moran. Does that suggest you are going to color 
within the lines?
    Secretary Burwell. It suggests that I need to read the 
statute, because I shouldn't answer a question--I apologize--
until I actually know what the statute says. I do want to 
actually abide by the statute.
    That is something at this point in the process, I 
apologize, I haven't gotten to. But I hear and understand that 
is something you will be following up on.
    Senator Moran. Thank you, Secretary.
    Senator Blunt. Senator Durbin.

                     NATIONAL INSTITUTES OF HEALTH

    Senator Durbin. Thank you, Madam Secretary, for being here. 
Let me associate myself with the remarks of Senator Merkley. As 
we delay this implementation of deeming as to e-cigarettes, 
more and more children are getting addicted. It is time. So I 
don't know where this has come to a halt, whether it's in your 
agency, or OMB, or some other place, but I am going to try to 
find out and move it along.
    Secondly, I met with Dr. Francis Collins a couple of years 
ago out at NIH. And I said to him, we can't aspire, sadly, to 
those glory days when Harkin and Specter and Porter doubled the 
budget for the NIH.
    Secretary Burwell. And I was at OMB.
    Senator Durbin. And you were at OMB.
    But what can we do that will make a difference? He said, I 
would tell you, 5 percent real growth for 10 straight years, he 
said, will light up the scoreboard. We will provide cures that 
more than pay for the cost of this research, and alleviate the 
human suffering involved.
    So I have been watching that standard, and I have to tell 
you that we are falling short of it. Over the last 10 years, we 
have fallen short by 23 percent of keeping up with inflation at 
NIH. So the number of grants awarded have been cut in half. 
That has discouraged researchers from staying.
    When I look at the President's budget request for NIH and 
CDC, I find for each of them roughly a 3 percent increase over 
last year. If you assume 2 percent inflation--and I understand 
OMB no longer assumes inflation. I guess that is how they avoid 
that conversation.
    But if you assume 2 percent inflation, you can see the 
minuscule amount that we are increasing NIH and CDC. I don't 
ever quote, and I rarely ever praise, Newt Gingrich but I am 
going to. He ends up writing in the New York Times this week: 
What are we thinking? We are spending a fortune on all the 
medical care associated with illness, disease, and yet we are 
not putting money into the research to alleviate it, as we 
should.
    I would just go a step beyond that and say he fell short of 
suggesting how we would pay for that, which would be the 
important ending to his story.
    But I just would like to say for the record--I have spoken 
to Senator Murray, to Senator Blunt, to Senator Alexander, and 
to others about this--I think it is time for us to step up as 
Congress and do something truly bipartisan that the American 
people will applaud, and say we are going to start a commitment 
of 5 percent plus inflation to key medical research. And we are 
going to do it on a bipartisan basis, no ifs, ands, or buts 
about it.
    I would just say, for the record, since I am the ranking 
member on the Defense Appropriations Subcommittee, if there is 
going to be some conversation about OCO money riding to the 
rescue of the Pentagon, I want to be part of that conversation, 
too. But I want to stick to the basic rules that Paul Ryan and 
Patty Murray came up with, that it is shared equally with non-
defense, that we make sure there is money coming back into the 
nondefense side of the equation, which is so important to 
Labor-H.
    So I hope that the administration will take the same 
position, that if we can find OCO money to help the Pentagon, 
I'm for that. But let us not do that at the expense of 
nondefense.
    And I hope, I hope, that we can come to a conclusion that 
we are going to make our mark in bipartisanship when it comes 
to biomedical research. Can't think of a more bipartisan issue.
    I open it to any comments you'd like to make.
    Secretary Burwell. I would just make two. One is that we, 
too, believe that, in terms of the numbers and the investments 
and the tradeoffs and the choices, we need to make those in 
terms of getting the Nation to function right now but preparing 
for the future in the way that you are talking about. That is 
why we make the choices that we do in the President's budget.
    And I would also repeat what you just said with regard to 
the match of increases in defense spending and nondefense 
spending.
    In terms of the health and security of our Nation, I think 
we saw what happens when Ebola comes to our border and that 
that is a health and national security issue, but it is one 
that is funded on the nondefense discretionary side.
    So making sure that we keep these two things moving and 
moving together is something that I think we think is extremely 
important.

                              WIC PROGRAM

    Senator Durbin. One other unrelated issue, the WIC program, 
I believe in it. I hope we can find ways to expand it, make it 
better.
    Do you have any idea what the eligible income is for 
qualifying for WIC is in the State of Iowa?
    Secretary Burwell. No, I do not.
    Senator Durbin. $90,000 a year. It turns out that when we 
coordinate the eligibility for Medicaid and WIC, that there is 
a great disparity among the States as to whether or not you 
qualify for WIC. I would like to suggest that the statutory 
standard that we used to have is somewhere near $45,000 as a 
maximum income that you could qualify for WIC. And because of 
this coordination of the Medicaid eligibility and WIC 
eligibility, there appears to be some gross disparities in some 
of the States.
    Would you look at that?
    Secretary Burwell. I would be happy to. I will work with 
Secretary Vilsack on these issues. But certainly, this is a 
number I have never seen, so I want to look into it and 
understand it.
    Senator Durbin. Thank you.

                           DIETARY STANDARDS

    Senator Blunt. Thank you. We have a little more time on the 
vote than we thought we had, so there is time for a second 
round here, and 11:55 is the scheduled time for the vote. So 
hopefully, we can work with that time.
    On the issue of dietary standards that Senator Moran 
brought up, he brought that same issue up at the FDA hearing 
and Commissioner Hamburg stated that she really didn't have a 
direct role in this and she was an adviser. Today, you have 
stated that you hadn't really looked at the law yet.
    Seems like there is a certain running for the hills here. 
Secretary Vilsack said that sustainability falls outside the 
guidelines.
    So the one person we have talked to who has looked at the 
law appears to think that sustainability is not an issue. You 
may want to argue it should be. All you have to do is change 
the law for that to happen, but not add it to the law.
    So we will be watching that, I am sure.

                             RISK CORRIDORS

    I have a couple of questions for the record. On risk 
corridor--the risk corridor program, Secretary, the Affordable 
Care Act--or at least last April. Let me be sure I am right 
here. The department released guidance stating that the risk 
corridor program would be implemented in a budget neutral 
manner.
    My impression from the discussions I am hearing now is that 
somehow the risk corridor program would find revenues somewhere 
else to make up the difference.
    Is that your view?
    Secretary Burwell. When the guidance was put out I was, 
going between. But with regard to risk corridors, a program 
that is about making sure we have premium control and downward 
pressure on premiums, something we all think is important, we 
believe it will be budget neutral. CBO has scored it as budget 
neutral.
    I think your follow-up question will be, what if it is not? 
And at this point in time, what we have said is, it is our 
expectation it will be budget neutral. CBO agrees with us, that 
it should be budget neutral. Certainly, in this year, what 
would happen if it weren't is it would fall into the next year, 
in terms of payments that come in to pay that.
    But if in the end, and the end, so we are clear of when the 
end is, is 2017, there were any issues, I think the insurers 
believe that commitments have been made. And at that point, one 
would have to find appropriated funds.
    Senator Blunt. And 2017 is the end of the program?
    Secretary Burwell. Yes. These are temporary----
    Senator Blunt. The theory being, by then, insurance 
companies should have figured out how to set up the structure 
and the marketplace and profile.
    Secretary Burwell. That is correct. So with regard to the 
three Rs, the risk corridors, reinsurance, and risk adjustment, 
two of those go away on that timetable.
    One of them was based on what we used to Medicare Part D 
that actually didn't go away in that kind of short time frame. 
But, yes, the idea is, by that time, people will understand the 
marketplace well enough to get this.
    Senator Blunt. Well, money from discretionary dollars, if 
that's necessary, would be something we would talk about next 
year, you would think? Or how would you fill in the gap?
    Secretary Burwell. I don't know that we are going to have 
any signals. We certainly won't have a signal even about this 
year until about the end of the summer, and then we will know 
on the first year, because it is a 3-year program. And right 
now, all the data is starting to come in.
    Senator Blunt. Designed in the scoring of the Affordable 
Care Act not to cost money.
    Secretary Burwell. Budget neutral is where it has been, at 
this point in time.
    Senator Blunt. We will see.

                       RECOVERY AUDIT CONTRACTORS

    On RAC audits, I think what I heard you say in response to 
Senator Lankford, is one of the things you were looking at was 
the incentive structure to bring these cases?
    Secretary Burwell. Yes. What we are looking at is in terms 
of the incentive structure to bring the cases, and to bring any 
case you wouldn't win. So if you bring a case that you are not 
going to win, you are not getting anything. If you bring a case 
that you can't get done in a set period of time, you don't get 
anything either. So changing some of those incentive structures 
is important.
    Part of the backlog occurs because there is no real cost 
for a provider to bring all their cases, to appeal so many, 
because there is only upside, as a provider.
    So, the cutoff is very low. I think we need to look at 
questions of what should the cutoff be for how little money you 
can appeal for, because of the question of processing.
    And then the second question is what are the steps for you, 
and is there any bar in terms of you appealing everything?
    So there is the issue of the RACs. There is the issue of 
the providers. And there is the issue of our processing. I 
think for all three of those things we can put in place 
improvements to both reduce the backlog, which is essential and 
we have been working with the Congress and have been working 
with others in a bipartisan way to make those improvements.
    The funding will be important. I think you know that it is 
a judicial process, so we have to have a certain type of 
appeals judge that can review. So we have a strategy that is 
about taking administrative actions, things that can get rid of 
some of the backlog, additional hires that we need to do to 
process the cases that are before us, and creating prevention 
in the pipeline so people are not as encouraged to do certain 
types of things, some of it related to RACs, to come into the 
system.
    Senator Blunt. Are you allowing new cases to be brought 
while you have this huge backlog out there?
    Secretary Burwell. The issue is divided in terms of the way 
the legislation was passed and what it banned that RACs could 
do. There is a time limitation with regard to the RACs. So some 
things are coming through but portions are not.
    Senator Blunt. Senator Murray.

                               HEAD START

    Senator Murray. Thank you.
    As you know, this year marks the 50th anniversary of Head 
Start, which is very exciting. I am really pleased to see the 
administration's request for a significant investment to make 
sure that Head Start kids get access to full-day, full-year 
programs. Some of the early childhood research on this is 
incredible, that an extended day learning, full-day pre-K, and 
effective teaching practices, strongly suggesting that the 
current 3.5 hour day is inadequate.
    So this is really an important step in making sure that 
Head Start prepares our children for success in kindergarten 
and later in life.
    I wanted to ask you, what is the administration doing to 
improve quality and make Head Start more effective?
    Secretary Burwell. The quality progress has taken place 
over a number of years. Part of it is that we are reviewing 
grantees with regard to certain measures of quality, and people 
are going to have to reapply. We have seen that happen across 
the country, in terms of those who are not meeting those 
standards and we are enforcing the quality standards.
    That is in the Head Start space. In the childcare space, 
thank you for the work you all did, in terms of the 
authorization last year. It's also given us guidance in that 
space as well.
    Senator Murray. One of the things I am hearing at home in 
Washington State is the lack of finding and retaining quality 
teachers.
    What is the department doing to deal with that?
    Secretary Burwell. That is actually a part of the quality 
standards, in terms of what types of degrees and training that 
teachers do have. And that is a part of what we are trying to 
do.
    We are seeing some increase in quality, in terms of 
educational background of teachers. I know that is not the only 
measure of quality, but we are seeing some progress in that 
number.

                      HEALTH CARE FRAUD AND ABUSE

    Senator Murray. Okay. I think that is important.
    My last question, and one that is important, is the fiscal 
year 2015 Omnibus represented the first time that the Labor-HHS 
bill utilized the Budget Control Act cap adjustment to fight 
fraud and abuse in Medicare and Medicaid since it was enacted 
in 2011. Current data indicates that for every dollar spent to 
address fraud, $7.60 is recovered by Treasury.
    So utilizing that cap adjustment, the Omnibus alone should 
create over about $5 billion in deficit reduction. I think 
that's a goal we all think is critically important. So I don't 
understand why anyone who wants to cut the deficit would oppose 
additional dollars for that fund.
    I know neither the House nor Senate budget resolution 
included funds for that. You did. Can you talk about how you 
can use these targeted resources to help us save money?
    Secretary Burwell. In the budget, we estimate based on the 
return that we have been seeing and we have used the 
conservative end of that to do the estimates. It would be about 
$22 billion, in the proposal from the President, in terms of 
the savings, if we continue on our path, in terms of Medicare 
issues.
    As I mentioned to you all before we came in, I had the 
privilege to attend the Sammies, which are the awards for 
public servants across the entire Federal Government, and those 
awards went to the people who were pursuing this fraud, and 
when we can see that kind of success, that cross-government 
work, we want to do more of it.
    We also know the issues of fraud and improper payments in 
Medicare are a large portion of what we see in the entire 
government. Having come from OMB and having spent lots of time 
with Mr. Carper and Dr. Coburn on this issue I am happy to be 
at a place where hopefully we can bear down and make some 
progress.
    Senator Murray. So if the cap adjustment is not allowed to 
be utilized, we will see an increase in spending?
    Secretary Burwell. We won't see the benefits that we would 
have gotten. We see those benefits coming every year and we 
report the numbers every year.
    It was 1:8 ratio last year. This past year it has been a 
one to almost eight, 1:7 ratio, in terms of the return we are 
getting.
    Senator Murray. Okay, thank you very much.
    Thank you, Mr. Chairman.

                           MEDICAID EXPANSION

    Senator Blunt. Senator Capito.
    Senator Capito. Thank you, Mr. Chairman.
    I had an additional question. In your statement, you talk 
about the ACA provides full funding in the Medicaid area all 
the way through 2016. And then in 2017, the State share then 
goes to 10 percent or less.
    The State of West Virginia, the legislature this year 
before the expansion had to fill an $80 million hole in their 
Medicaid budget this year, with no cost of the 140,000 new 
expansion Medicaid recipients.
    I raised this question when this was going through, when we 
were voting on this, when it was passed. How are the States, my 
State, our State, going to be able to meet these budgetary 
expansions that they have taken on themselves because they have 
expanded Medicaid by 140,000 people when they are already short 
$80 million this year without expansion?
    Secretary Burwell. I think there are two things, as we 
think about the answer to the question of how you financially 
do the Medicaid expansion in a State.
    The first is, in Kentucky, they did a baseline study before 
Governor Beshear expanded Medicaid. He did a follow-up study 
with Deloitte and the University of Louisville. It was about 3 
months ago and look at what actually has happened with the 
Medicaid expansion and how you predict that out economically.
    In the State of Kentucky, what the study showed is that 
there would be 40,000 more jobs and $30 billion to the State's 
coffers, in terms of what the Medicaid expansion would result 
in, in terms of the economic growth. I think that is one part 
of the answer.
    I think the other part of the answer to the question, which 
is an important one, has to do with delivery system reform. 
That has to do with why we are so deeply focused on changing 
the way care is delivered and the quality of that care.
    You and I had an opportunity to talk about the fact that 
one of the things that drives this is emergency room use. And 
while the analytics are not strong enough yet, we are starting 
to see that decrease.
    What we are trying to do is to make sure we get to the 
place where people are not using the most expensive care and 
using the care in ways that we can save and have quality.
    That is an effort that right now we are very focused on 
with CMS and helping new people who have never been insured 
before to use the care in ways that, one, they understand how 
to access the care; two, they understand how to read their 
bills; and three, they understand that there are tools to keep 
them healthy.
    The diabetes numbers that we are seeing out of States that 
have expanded, are encouraging.
    Senator Capito. I would say that all sounds like it is 
going to solve this problem, but we are talking about, this is 
on the horizon here. An $80 million budget hole shortfall 
already without the expansion, you know, you are talking about 
changing behaviors, and we know it is not going to take a year. 
It is probably going to be a 5 or 10 year kind of thing.
    With the creation of 40,000 jobs, I wish I saw jobs growing 
in our State, but, unfortunately, that is not happening. We 
have a lot more people unemployed in higher paid areas, and you 
know what I am talking about. So we have a real problem here.
    I am very concerned about that. By this time, the President 
and you will be gone, by the time 2017 comes along. And we are 
going to have a new Governor in our State, and that is going to 
be a difficult challenge for that Governor.

                  CHILDREN'S HEALTH INSURANCE PROGRAM

    Last question, this should be a simple answer, and I think 
I am just not seeing the numbers correct. If you expand 
Medicaid, which we have in West Virginia, and you have asked 
for an increase in budget in Children's Health Insurance 
Program, sizable, $3.9 billion, it looks like if I am reading 
the numbers right. Somebody asked me this, I thought it was a 
great question and I didn't have the answer. If you are 
expanding Medicaid, which is pulling in those families and 
children, wouldn't the cost of the Children's Health Insurance 
Program go down because a lot of those children are being 
pulled into Medicaid expansion?
    Secretary Burwell. So the children covered by CHIP are 
staying in CHIP, and that was part of what the SGR bill just 
did. So those children are actually not moving over. That's 
why.
    Senator Capito. So if you are in CHIP and your family goes 
into Medicaid, your mom and dad go into Medicaid, you are not 
required to pull that child into Medicaid with you? You stay in 
the CHIP program?
    Secretary Burwell. That is correct.
    Senator Capito. I mean, I worked on the CHIP program as a 
State representative. I am a big believer in it. I have always 
voted for expansions of it, because it is important in our 
State.
    So I guess you have answered my question. I guess my 
follow-up question would be, from an economic standpoint, is it 
more beneficial to the State and the Federal Government to keep 
that child in CHIP financially--I am not talking about quality 
of care and all that because I believe in that--or to go into 
the Medicaid program? What is less costly?
    Secretary Burwell. That is a piece of work that I think is 
coming out in the next weeks, in terms of an analysis that we 
have been asked to do, with regard to the question of does CHIP 
cost more or does Medicaid cost more?
    That is something we are coming out with in the next weeks, 
as part of the follow-up to the ACA and one of the reports we 
have been asked to do.
    Senator Capito. I look forward to seeing the report. Thank 
you.

                            KING V. BURWELL

    Senator Blunt. So one last question, then there will be 
questions for the record. I will have them and others will as 
well.
    But my next thing on my schedule is to go to a meeting of 
Senators who are talking about what to do based on the result 
of King v. Burwell. In the past, you have said that, really, 
you are not looking at options if the Court rules that the 
subsidies aren't valid in a number of States.
    Is that still your position?
    Secretary Burwell. I think it is important for me to state 
we believe we will win the case and that based on both the 
letter and the intent of the law, that we hold the correct 
position.
    But with regard to if the Court decides for the plaintiffs, 
at that point the Court will have said we cannot provide those 
subsidies. And at the point at which that happens, our ability 
to have authorities to do the subsidies is not something that 
exists. So the real problem is people lose subsidies, and they 
then become uninsured, because they were insured because of the 
affordability. Then the question is of a death spiral in the 
marketplace because now sicker people are in, and that drives 
premiums up. And then the question is how that affects States, 
in terms of costs.
    All three of those things result from the loss of 
subsidies. That's the problem we are trying to solve. And the 
question is, if the Court says we don't have the authority, how 
do I have an authority the Court says I don't.
    So that is why, when asked about a plan to resolve the 
massive damage, that's not necessarily something, if the Court 
makes that kind of decision, that we have seen that we have an 
authority.
    Senator Blunt. We will see what the Court says.

                     ADDITIONAL COMMITTEE QUESTIONS

    The record will stay open for one week for additional 
questions.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]
                Questions Submitted by Senator Roy Blunt
           privacy of consumer information on healthcare.gov
    Question. In January of 2015, the Associated Press published an 
article stating that HHS was sharing sensitive personal information 
from applicants of Healthcare.gov. Why was HHS sharing personal 
consumer information with third party, Internet marketing vendors?
    Answer. No third-party tools have had access to names, addresses, 
Social Security Numbers, or any of the information entered into the 
application through HealthCare.gov, and no person or group has 
maliciously accessed personally identifiable information from the site. 
CMS does not sell or market any information entered into 
HealthCare.gov.
    Your question references the information that was available to 
third-party tools through a plain-text URL on the Window Shopping 
feature on the site used to estimate plan costs. The inputs that were 
unencrypted in the URL included zip code, age, smoking status, 
pregnancy status, and income. The URL never contained names, addresses, 
or Social Security Numbers. Immediately after these concerns were 
raised, CMS began reviewing its use of third-party tools and encrypted 
the text of the Window Shopping URL. We have found no evidence that any 
third-party tool misused the anonymous, unverified information entered 
into the Window Shopping feature. The issues raised about 
HealthCare.gov's use of third-party tools also prompted CMS to conduct 
a review of the third-party tools. We removed third-party tools we 
viewed as redundant.
    Additionally, we are in the process of updating our Privacy Impact 
Assessments (PIAs) and adding new PIAs to further strengthen our 
privacy procedures. This process and review includes looking to see how 
we could strengthen our contracts to further safeguard consumer 
information.
    Question. What types of information were shared with the vendors 
and how was it used?
    Answer. Your question references the information that was available 
to third-party tools through a plain-text URL on the Window Shopping 
feature on the site used to estimate plan costs. The inputs that were 
unencrypted in the URL included zip code, age, smoking status, 
pregnancy status, and income. The URL never contained names, addresses, 
or Social Security Numbers. Immediately after these concerns were 
raised, CMS began reviewing its use of third-party tools and encrypted 
the text of the Window Shopping URL. We have found no evidence that any 
third-party tool misused the anonymous, unverified information entered 
into the Window Shopping feature.
    Through Healthcare.gov, third-party tools continue to have access 
to computer information such as browser information or URLs, (as is the 
case when any computer user visits any Internet site). As is stated in 
the HealthCare.gov Privacy Policy, the third-party tools collect the 
following information:
  --Internet domains;
  --IP addresses;
  --Operating systems and browser information;
  --Date and time of visits;
  --URLs of the pages visited; and
  --Addresses of the websites that connected users to HealthCare.gov.
    CMS does not sell or rent any information entered into 
HealthCare.gov. We use third-party tools to better serve our consumers. 
Through the third-party tools, we work with private sector companies to 
provide insight into improving site performance, and, during Open 
Enrollment, conduct outreach efforts to eligible consumers. As is 
common for consumer-facing websites, we use third-party tools to 
analyze HealthCare.gov's technical performance and to measure the 
effectiveness and cost-benefit of our outreach efforts.
    Question. Did HHS make consumers aware that their information was 
going to be shared with a third party for marketing purposes?
    Answer. The website's privacy notice, which is publicly posted in 
plain language, describes the use of the third-party tools. The privacy 
notice also explains how consumers can ``opt out or disable'' cookies. 
The notice is linked through HealthCare.gov's home screen, as well as 
through several screens throughout the site. We are updating the 
HealthCare.gov privacy policy to more clearly describe the use of these 
tools.
    Question. Was proper consent obtained to share this type of 
information?
    Answer. The website's privacy notice, which is publicly posted in 
plain language, describes the use of the third-party tools. The privacy 
notice also explains how consumers can ``opt out or disable'' cookies. 
The notice is linked through HealthCare.gov's home screen, as well as 
through several screens throughout the site. We are updating the 
HealthCare.gov privacy policy to more clearly describe the use of these 
tools.
    Question. Is HHS continuing to share this type of information with 
third parties?
    Answer. Immediately after concerns were raised, CMS began reviewing 
its use of third-party tools and encrypted the text of the Window 
Shopping URL, so that the inputs for the Window Shopping tool were no 
longer available to third-party tools through the URL. The issues 
raised about HealthCare.gov's use of third-party tools also prompted 
CMS to conduct a review of the third-party tools. We removed third-
party tools we viewed as redundant. Additionally, we are in the process 
of updating our Privacy Impact Assessments (PIAs) and adding new PIAs 
to further strengthen our privacy procedures. This process and review 
includes looking to see how we could strengthen our contracts to 
further safeguard consumer information.
    Question. What is HHS doing to protect individuals' privacy?
    Answer. We are committed to the protection of consumer information 
entrusted with us at HealthCare.gov. We are continuing our ongoing 
review and are looking for additional ways to strengthen our privacy 
practices. We know that consumers put their trust in us when they visit 
HealthCare.gov, and that is why we are constantly strengthening our 
security and privacy controls. CMS developed the Marketplace systems 
relying on Federal statutes, guidelines, and industry standards that 
helped us to create standards, processes, and controls for the security 
and integrity of the systems and the data that flow through them. CMS 
has implemented measures to protect personal information, including 
ongoing penetration testing and automated scanning, consistent with 
FISMA requirements and industry best practices so that security 
controls are effective in safeguarding consumers' personal information.
                  gao report on serious mental illness
    Question. GAO recommended that HHS establish a mechanism to 
coordinate across all the programs that support individuals with 
serious mental illness and document which programs should be evaluated 
and how often. HHS disagreed with both of these recommendations stating 
that staff level coordination and other performance measures are 
undervalued in the study. How does HHS plan to correct this situation?
    Answer. Regarding GAO's recommendation related to coordination, HHS 
is strongly committed to promoting care coordination for people with 
serious mental illnesses (SMI). We believe more can be done at all 
levels to coordinate care for this vulnerable population. HHS is 
building upon and expanding intra- and inter-agency Federal 
coordination efforts related to individuals with SMI. In so doing, HHS 
is leveraging existing Federal coordination methods including the 
Behavioral Health Coordinating Council (BHCC) Subcommittee on Serious 
Mental Illness, the Interagency Task Force on Military and Veterans 
Mental Health, the National Action Alliance for Suicide Prevention, the 
U.S. Interagency Council on Homelessness, the Re-entry Policy Council, 
and senior-level communication.
    In addition to the existing coordination within HHS and with other 
Federal partners, SAMHSA and the Office of the Assistant Secretary for 
Planning and Evaluation (ASPE) will co-lead an effort to address the 
needs of individuals with SMI and their families, across the Federal 
Government. This effort will occur in conjunction with the SMI 
Subcommittee and include current work with the Department of Housing 
and Urban Development (HUD), the Department of Justice (DOJ), the 
Department of Defense (DOD), the Department of Veterans Affairs (VA), 
the Social Security Administration (SSA), the Department of Labor 
(DOL), the Department of Education (ED) and other Federal departments. 
SAMHSA and ASPE will work to engage these Departments in this effort, 
and specifically to identify additional programmatic and policy 
approaches to address critical, unmet needs for this population.
    I agree that evaluation of major programs is essential to 
understanding impact and improving services for consumers. I am working 
with ASPE to continue improving our efforts to identify which programs 
should be evaluated and how they should be evaluated, including the 
timing of those evaluations. Decisions regarding which programs to 
target for evaluation will be informed by a number of factors such as 
statutory requirements regarding reports to Congress, availability of 
funds for evaluation, impact, permanence of the program, and size of 
the program.
                 2015 dietary guidelines for americans
    Question. There are significant concerns that the Advisory 
Committee on Dietary Guidelines has gone outside its purview by 
recommending Americans eat less meat because it is better for the 
environment. Do you believe the recommendation to eat less meat falls 
outside the statutory authority?
    Answer. The Department understands there are concerns regarding the 
recommended level of meat that Americans eat. The 2015 Dietary 
Guidelines Advisory Committee's current recommendation for Americans to 
eat less meat is based on improving health and is consistent with 
previous recommendations. The Advisory Committee did not recommend that 
Americans eat less meat because it is better for the environment; 
rather they recommended eating less meat because it is better for the 
health of Americans.
    A recommendation to eat less red meat does not fall outside the 
statutory authority. We are aware that there is misunderstanding about 
what the Advisory Report recommends regarding meat consumption and 
health, with some mistakenly believing that the report recommends that 
lean meats (including lean red meats) not be included in the 2015 
Dietary Guidelines for Americans. This is not the case. To be clear, 
the Committee's quantitative recommendation for lean meats (see 
Advisory Report Table D1.32) is identical to the quantitative 
recommendation in the current Dietary Guidelines for Americans 2010 
(see 2010 Dietary Guidelines Appendix 7).
    The 2015 Advisory Committee's recommendation to lower intake of 
meat was in reference to the amount currently consumed--not a 
recommendation to lower the current Dietary Guidelines quantitative 
amount--and is consistent with the 2010 Dietary Guidelines 
recommendation to lower current intake. The Advisory Committee's 
decision to uphold the recommendation was based on current national 
intake data (National Health and Nutrition Examination Survey, What We 
Eat in America, 2007-2010) showing that almost 60 percent of persons 
aged 1 year and older eat more ``meat, poultry, and eggs'' than 
recommended, while approximately 20 percent meet this recommendation, 
and 20 percent have intake below the recommendation (see Advisory 
Report Figure D1.21). Thus, the Committee's statement to reduce meat 
consumption compared to current consumption is within the context of 
the need to move closer to meeting all food group recommendations and 
staying within calorie limits, and is unchanged from the current 
recommendation in the 2010 Dietary Guidelines for Americans.
    The Advisory Committee's recommendation to eat less red and 
processed meat was based on looking at research on various dietary 
patterns and health outcomes. For example, the Advisory Committee found 
that patterns associated with a decreased risk of cardiovascular 
disease are characterized by higher consumption of vegetables, fruits, 
whole grains, low-fat dairy, and seafood, and lower consumption of red 
and processed meat, and lower intakes of refined grains, and sugar-
sweetened foods and beverages relative to less healthy patterns. In 
addition as noted in the Advisory Report Figure D2.2 from the American 
Institute for Cancer Research, colon cancer is strongly linked to 
consumption of red meat.
    Question. It also appears the DGAC decided to go into areas far 
outside the scope required. For instance, the DGAC decided to address 
issues such as taxing soft drinks and limiting the types of food and 
beverages allowed for purchase using SNAP benefits. Do these areas fall 
outside the statutory authority?
    Answer. The 2015 Advisory Committee, similar to several previous 
advisory committees, included in its review food- and nutrition-related 
topics that go beyond dietary intake alone but are closely related, 
such as physical activity and food safety. The 2015 Committee did not 
review scientific evidence related to the interaction between tax 
policy and nutrition or health outcomes; rather, it identified taxation 
as one potential strategy, not a recommendation, to help people meet 
the Dietary Guidelines for Americans. The purpose of the Dietary 
Guidelines remains to provide food-based recommendations to help 
promote health and prevent disease and not to set policies in other 
realms, such as taxation.
    Question. Who will ultimately make the decision as to what is 
included in the 2015 Dietary Guidelines?
    Answer. The U.S. Departments of Health and Human Services (HHS) and 
Agriculture (USDA) are in the process of developing the eighth edition 
of the Dietary Guidelines. The Departments are reviewing the 
``Scientific Report of the 2015 Dietary Guidelines Advisory Committee'' 
along with comments from Federal agencies and the public to develop the 
Dietary Guidelines for Americans, 2015. Nutrition science and policy 
experts from HHS and USDA write this policy document. It then undergoes 
external peer review, and review and clearance within the Federal 
Government prior to being approved and released by HHS and USDA 
Secretaries.
    Question. The DGAC recommends separate labeling of ``added 
sugars,'' specifying such sugars should be limited to 10 percent of 
caloric intake. What research supported a listing of sugar as 
``added?''
    Answer. The 2015 Advisory Committee used the definition of added 
sugars from the Food and Drug Administration's proposed rule on the 
revision of the nutrition and supplement facts labels (docket no. FDA-
2012-N-1210), March 2014. As defined in the Committee's Advisory 
Report, added sugars are ``sugars that are either added during the 
processing of foods, or are packaged as such. They include sugars 
(free, mono-and disaccharides), syrups, naturally occurring sugars that 
are isolated from a whole food and concentrated so that sugar is the 
primary component (e.g., fruit juice concentrates), and other caloric 
sweeteners. Names for added sugars include: brown sugar, corn 
sweetener, corn syrup, dextrose, fructose, fruit juice concentrates, 
glucose, high-fructose corn syrup, honey, invert sugar, lactose, 
maltose, malt sugar, molasses, raw sugar, turbinado sugar, trehalose, 
and sucrose.''
    The 2015 DGAC found that added sugars are a significant source of 
calories in the American diet. The average intake is 13.4 percent of 
calories, with children, teenagers and young adults having a greater 
percentage of calories from added sugars at 15-17 percent. Many of the 
major food sources of added sugars supply calories but few or no 
essential nutrients (see Advisory Report figure D1.38).
    The DGAC focused its research on the relationship between the 
consumption of added sugars and health implications. As noted in its 
Scientific Report, the Advisory Committee concluded that strong and 
consistent evidence shows that intake of added sugars from food and/or 
sugar-sweetened beverages is associated with excess body weight in 
children and adults and with the development of type 2 diabetes in 
adults. There is moderate evidence that higher intake of added sugars 
is consistently associated with increased risk of hypertension, stroke, 
and coronary heart disease in adults and with dental caries in children 
and adults. The Advisory Committee also found that limiting the amount 
of added sugar in one's diet is necessary to meet the recommended food 
group and nutrient needs while staying within calorie limits (see 
Advisory Committee Report Part D Chapter 6, Question 6). The Advisory 
Committee's recommendation to reduce added sugars to no more than 10 
percent of total calories is consistent with, although more specific 
than the current Dietary Guidelines for Americans, 2010, which 
recommends that Americans reduce their intake of calories from added 
sugars in general and includes limits on ``calories from solid fats and 
added sugars'' that can be accommodated in the USDA Food Patterns to 
meet nutrient needs within calorie limits.
                  funding for medical countermeasures
    Question. What is the impact to our Nation's biodefense enterprise 
if the SRF, BARDA, and SNS are not fully funded?
    Answer. The fiscal year 2016 Budget funding level for Project 
BioShield keeps the program on track to procure twelve new medical 
countermeasures that will expand our current level of biodefense 
preparedness. This level will also enable Project BioShield to provide 
enhanced versions for at least three existing medical countermeasures 
to maintain our current level of biodefense preparedness for chemical, 
biological, radiological, and nuclear threats. These project goals are 
based on the $2.8 billion level, authorized under Pandemic and All 
Hazards Preparedness Reauthorization Act in 2013. The Project BioShield 
activities at this level were also outlined in the HHS Medical 
Countermeasure Multiyear Budget report submitted to Congress in March, 
2015.
    The fiscal year 2016 Budget level for BARDA would ensure the 
existing medical countermeasure development pipeline and the continued 
momentum and benefits of prior year investments, totaling hundreds of 
millions of dollars. Without BARDA funding, some industry partners may 
leave the biodefense and infectious disease sector for more secure 
returns on their investments in the pharmaceutical commercial market.
    If the Strategic National Stockpile (within the Centers for Disease 
Control and Prevention) is not funded at the fiscal year 2016 
President's Budget level, our ability to procure, maintain, and 
replenish existing or new medical countermeasures for biodefense may be 
inhibited.
    In the absence of full funding for these programs, we may not be 
able to continue replenishing existing medical countermeasures. Second, 
progress might not be made against existing gaps in preparedness which 
might otherwise be filled by new medical countermeasures (e.g., 
nuclear, chemical, and viral hemorrhagic fever). Third, medical 
countermeasure developers may, in time no longer see the U.S. 
Government as a reliable partner and may be encouraged to leave the 
biodefense sector completely.
    Question. What activities and MCMs will we lose?
    Answer. The U.S. may become increasingly less prepared for 
biodefense threats for which Project BioShield has already provided 
medical countermeasures (MCMs) (e.g., anthrax and smallpox). 
Additionally, the threat gaps to be filled by some of the new MCMs will 
remain open (e.g., nuclear, chemical, and viral hemorrhagic fever).
    At a funding level below the fiscal year 2016 Budget request, 
Project BioShield may no longer be on track to meet the goals of the 
fully authorized level of $2.8 billion. If underfunded, BARDA and the 
Public Health Emergency Medical Countermeasure Enterprise (which is an 
inter- and intra-Departmental advisory group) would re-prioritize the 
quantities of new and enhanced MCMs to be purchased, pending available 
funds. The result of prioritization efforts may be that some threats 
will be unaddressed (e.g., chemical nerve agents).
    Question. How will you pick and choose which MCMs and projects have 
to be scrapped?
    Answer. At a funding level below the fiscal year 2016 Budget 
request, BARDA and the Public Health Emergency Medical Countermeasure 
Enterprise will work together to re-prioritize the planned procurement 
quantities of new and enhanced medical countermeasures (MCMs) based on: 
(1) threat vulnerability; (2) the availability of a product already in 
the Strategic National Stockpile to address the threat; (3) the product 
stage of development; and (4) the cost. For BARDA Advanced Research and 
Development programs, prioritization for funding will be based on the 
maturity of the respective MCM program, availability of products 
procured under Project BioShield and already in the Strategic National 
Stockpile, threat vulnerability, and cost to develop the MCM for 
Project BioShield procurement. The launch more effective and universal 
influenza vaccines, influenza immunotherapeutics, and emerging 
infectious disease MCMs, would also be curtailed if funding is reduced.
    Question. How would ASPR try to soften the impact if SRF, BARDA, 
and SNS are not fully funded?
    Answer. If the fiscal year 2016 President's Budget levels for 
Project BioShield and the Biomedical Advanced Research and Development 
Authority (within the Office of the Assistant Secretary for 
Preparedness and Response) and the Strategic National Stockpile (within 
the Centers for Disease Control and Prevention) are not fully funded, 
the Public Health Emergency Medical Countermeasure Enterprise will 
reassess planned procurements and research priorities within the budget 
levels, and reprioritize as needed to maintain the highest levels of 
preparedness.
             national preparedness for a pandemic outbreak
    Question. Based on our experience to the domestic public health 
response to Ebola in this country, are we prepared to deal with a 
pandemic outbreak in the United States?
    Answer. For an influenza pandemic, HHS has made great strides since 
the H1N1 pandemic in 2009 to strengthen the Nation's preparedness for 
mild to severe pandemics. The number of approved products and 
requirements for antiviral drugs, ventilators, and respiratory 
protective devices are evidence of the improved coordination across the 
entire medical countermeasure continuum.
    Below are specific examples of the progress HHS has made towards 
improved pandemic preparedness:
  --CDC has improved global surveillance and virus characterization to 
        detect emergent influenza and other infectious disease strains 
        more quickly.
  --CDC and BARDA have established and maintained influenza antiviral 
        drug stockpiles for at least 20 percent of the Nation's 
        population.
  --Domestic influenza vaccine manufacturing capacity has increased 
        four to five fold to meet the U.S. demands for pandemic 
        influenza vaccine with new cell- and recombinant-based 
        vaccines, antigen-sparing vaccines using adjuvants, 
        retrofitting of older manufacturing facilities, and building of 
        new manufacturing facilities.
  --BARDA established the National Medical Countermeasure Response 
        Infrastructure to develop, manufacture, and test vaccines and 
        therapeutics rapidly and nimbly for pandemic influenza and 
        emerging infectious diseases.
  --BARDA established pre-pandemic H5N1 and H7N9 influenza vaccine 
        stockpiles to address needs for critical infrastructure.
  --BARDA incorporated technological improvements to speed production 
        of pandemic influenza vaccines (e.g. H7N9 vaccines in 2013) by 
        several weeks through the Influenza Vaccine Manufacturing 
        Improvement Initiative (a partnership between HHS, industry, 
        and academics), to improve vaccine seed candidates, potency 
        assays, and sterility assays for vaccines.
  --BARDA supported the development of more effective and universal 
        influenza vaccines that may provide longer and broader cross 
        protection across influenza virus strains and serve as primers 
        for single-dose pandemic influenza vaccines.
  --BARDA supported development of new influenza antiviral drug and 
        immunotherapeutic candidates to treat severe influenza cases.
  --BARDA supported development of rapid diagnostics to detect 
        influenza in point-of-care and high throughput laboratory 
        settings.
  --BARDA improved the systems for distribution, administration, and 
        monitoring of influenza vaccines during pandemics.
    HHS/ASPR has also developed a healthcare assessment tool to assess 
the impact an incident is having on the healthcare delivery system's 
ability to appropriately care for patients with conventional, 
contingency, and potentially crisis standards of care. Specifically, 
the ASPR healthcare assessment tool is a surge strategy designed to 
assess the increased stress on the healthcare system due to conditions 
prompted by public health incidents, such as influenza.
    In response to the recent Ebola crisis, HHS/ASPR and CDC are 
working together to fund and establish the National Ebola Training and 
Education Center (NETEC). The NETEC will increase the competency of 
healthcare and public health workers and the capability of healthcare 
facilities to deliver safe, efficient, and effective Ebola patient care 
through the nationwide, regional network for treatment of Ebola and 
other infectious diseases. Composed of staff from hospitals that have 
successfully evaluated and treated Ebola patients in the U.S., and in 
collaboration with staff from CDC and ASPR, the NETEC will offer 
expertise, education, training, technical assistance, peer review 
assessments, recognition, reporting, and, if feasible, certification to 
regional Ebola and other special pathogen treatment centers, State- and 
jurisdiction-based Ebola treatment centers, and assessment hospitals.
    HHS/ASPR, through the Hospital Preparedness Program's funding 
opportunity announcement, Ebola Preparedness and Response Activities, 
is developing a regional approach to caring for future patients with 
Ebola. This regional approach includes up to ten Ebola treatment 
centers, which will be designated to serve as Regional Ebola and Other 
Special Pathogens Treatment Centers, one in each of the ten HHS 
regions. These regional centers will have enhanced capacity and 
capabilities to care for patients with Ebola and other highly 
infectious diseases, and they will be ready within a few hours' notice 
to receive a patient with confirmed illness from their region, across 
the United States, or medically-evacuated from outside of the United 
States, as necessary.
          lessons learned from u.s. domestic response to ebola
    Question. There was a systemic public health failure in responding 
to the Ebola patient in Dallas. What have we learned from our mistakes 
there?
    Answer. HHS is actively working to identify lessons learned related 
to domestic preparedness and international response to Ebola Virus 
Disease; the review will focus on the strengths and opportunities for 
improvement in executing the capabilities required for a successful 
pandemic-like response. In its role as the Federal leader for health 
preparedness and response, ASPR has convened the major Department 
components involved in the response, and will continue to solicit their 
input. HHS is also looking to utilize a small panel of outside experts, 
with a chairperson from the Public Health and Medical community, to 
support the development of formal report. As corrective actions are 
identified, HHS will work with relevant stakeholders to implement 
actions to improve response going forward. One of the primary lessons 
learned from the overall national response to Ebola is that more 
flexible funding would have improved the response immensely. As such, 
the fiscal year 2016 President's Budget includes a new $110 million 
initiative that will provide funds which can be available immediately 
to responds to an urgent need, including a disease outbreak, a 
disaster, or an urgent or emergency public healthcare need. This 
funding could be provided to States quickly in an emergency as well as 
supplement Federal assets as needed.
                         risk corridors program
    Question. Why does HHS propose to eliminate the General Provision 
that this Subcommittee included in the fiscal year 2015 Omnibus to 
prohibit any discretionary funds for the Risk Corridor program?
    Answer. We do not believe the language is necessary based on 
projections of budget neutrality. The proposal does not reflect a 
change to the Administration's policy or expectations.
    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?
    Answer. The temporary risk corridor provision in the Affordable 
Care Act will play an important role in mitigating premium increases in 
the early years as issuers gain more experience in setting their rates 
for this new program.
    Although we cannot yet calculate the risk corridor payments for 
plan years 2014 through 2016, current budget projections, including 
those by the Congressional Budget Office, reflect that money collected 
from the risk corridor program will be sufficient for payments during 
the 3 years for which it is authorized. In the unlikely event of a 
shortfall for the 2016 program year, HHS recognizes that the Affordable 
Care Act requires us to make full payments to issuers. In that event, 
HHS will use other sources of funding for the risk corridors payments, 
subject to the availability of appropriations.
                       recovery audit contractors
    Question. Can you provide us with an update on the cross-agency 
working group?
    Answer. The Department created an interagency workgroup comprising 
representatives from the Centers for Medicare & Medicaid Services, the 
Office of Medicare Hearings and Appeals (OMHA), the Departmental 
Appeals Board, and the Office of the Secretary to conduct a thorough 
review of the Medicare appeals process and develop a series of 
initiatives to improve the efficiency of the Medicare appeals process 
and reduce the backlog of appeals. Below are several highlights of the 
administrative initiatives currently underway and legislative proposals 
included in the fiscal year 2016 President's Budget. The administrative 
initiatives and legislative proposals are designed to both reduce the 
current backlog of pending appeals and resolve claims at the lowest 
level.
Administrative Initiatives
  --Administrative settlement of high volume appeals
  --Settlement conference facilitation pilot
  --Voluntary statistical sampling pilot
  --Prior authorization of power mobility device demonstration
  --The Center for Medicare & Medicaid Innovation (CMMI) prior 
        authorization models
  --Provider education efforts administered by CMS
Legislative Proposals
  --Provide reimbursement for administration from recovery audit 
        program at all HHS appeal levels
  --Sample and consolidate similar claims for administrative efficiency
  --Establish a refundable filing fee for Medicare Parts A & B Appeals
  --Remand appeals to the redetermination level with the introduction 
        of new evidence
  --Increase minimum amount in controversy for administrative law judge 
        adjudication of claims to equal amount required for judicial 
        review
  --Establish magistrate adjudication for claims with amount in 
        controversy below new ALJ amount in controversy threshold
  --Expedite procedures for claims with no material fact in dispute
    Question. Specifically, what are they doing to address the RAC 
issue and current back log at the Office of Medicare Hearings and 
Appeals?
    Answer. The Department has a three-pronged approach to addressing 
the increasing number of Medicare appeals and the current backlog of 
claims to be adjudicated. First, invest new resources at all levels of 
appeal to increase adjudication capacity and implement new strategies 
to alleviate the current backlog. Second, take administrative actions 
to reduce the number of pending appeals and more efficiently handle new 
cases that are entering the appeals process. Third, pursue legislative 
proposals described in the President's fiscal year 2016 Budget that 
provide additional funding and new authorities to address this urgent 
need.
    Question. How will the budget request specifically help address the 
root problem with overaggressive RACs?
    Answer. The fiscal year 2016 Budget included a request for 
statutory authority to conduct Prior Authorization for Medicare Fee-
for-service Items. Items that are reviewed through Prior Authorization 
would be excluded from Recovery Auditor reviews.
    CMS has announced a number of future changes to the Recovery Audit 
Program in response to industry feedback. In the process of procuring 
new contracts, these changes will result in a more effective and 
efficient program, including improved accuracy, less provider burden, 
and more program transparency. A comprehensive list of the Recovery 
Auditor program improvements can be found at: http://www.cms.gov/
Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-
Compliance-Programs/Recovery-Audit-Program/Downloads/RAC-Program-
Improvements.pdf.
                         cdc laboratory safety
    Question. What is the status of the recommendations put forth by 
the new advisory committee?
    Answer. CDC concurs with the recommendations put forward by the 
external Laboratory Safety Workgroup of the Advisory Committee to the 
Director of CDC, has made progress towards implementing them, and 
reported to the Advisory Committee to the Director on that progress at 
its April 23, 2015 meeting. The external Laboratory Safety Workgroup is 
comprised of external experts in the fields of biosafety, laboratory 
science, and research, and it provides advice, recommendations, and 
guidance to CDC on establishing an operative and sustainable culture 
with regards to laboratory safety and quality at CDC. A copy of CDC's 
presentation to the Advisory Committee to the Director is available on 
CDC's website here http://www.cdc.gov/about/pdf/lab-safety/cdc-
labsafetyupdate-acdpresentation-5-05-2015.pdf. CDC will continue to 
work toward implementing the recommendations and will continue to 
engage the external Laboratory Safety Workgroup and the Advisory 
Committee to the Director, as well as provide updates on the agency's 
progress.
                     raise early treatment program
    Question. Are we seeing progress with the RAISE program in States 
such as Missouri, and is it effectively reaching the population it was 
designed to help?
    Answer. Evidence to date indicates the Recovery After an Initial 
Schizophrenia Episode (RAISE) program and efforts to further 
disseminate and implement initial research findings through the 
Substance Abuse and Mental Health Administration (SAMHSA) Mental Health 
Block Grant (MHBG) program are benefitting individuals who experience a 
first episode of psychosis. The Department will continue working to 
expand the number of community-based settings offering this model of 
coordinated specialty care.
    As you are aware, the National Institute of Mental Health (NIMH) 
launched the RAISE initiative in 2009 to test the effectiveness of 
coordinated specialty care programs for individuals experiencing a 
first episode of psychosis in the United States.\1\ Coordinated 
specialty care is intended to help people recover after an initial 
psychotic episode and reduce the likelihood of future episodes and 
long-term disability.
---------------------------------------------------------------------------
    \1\ See http://www.nimh.nih.gov/health/topics/schizophrenia/raise/
index.shtml.
---------------------------------------------------------------------------
    Two research investigations--the RAISE Early Treatment Program and 
the RAISE Connection Program--were funded to develop, test, and 
implement coordinated specialty care in community treatment settings. 
Initial results from the RAISE projects suggest that mental health 
providers across multiple disciplines can learn the principles of 
coordinated specialty care, and apply these skills to effectively 
engage and treat persons in the early stages of psychotic illness.\2\ 
For individuals in the coordinated specialty care program, both 
symptoms and quality of life improved significantly and more rapidly 
than those of individuals who received typical community care for first 
episode of psychosis. Additionally, individuals in the coordinated 
specialty care program were more likely to be working or going to 
school. These early findings, combined with the existing evidence 
supporting early intervention in psychosis, are compelling and have 
informed the Department's efforts to implement this intervention more 
broadly.
---------------------------------------------------------------------------
    \2\ Dixon LB, Goldman HH, Bennett, ME, Wang Y, McNamara KA, Mendon, 
SJ, Goldstein AB, Choi C-WJ, Lee RJ, Lieberman JA, & Essock SM. (2015). 
Implementing Coordinated Specialty Care for Early Psychosis: The RAISE 
Connection Program. Psychiatric Service. PubMed ID 25772764.
---------------------------------------------------------------------------
    The fiscal year 2014 Consolidated Appropriations Act provided funds 
to SAMHSA to support the development of early psychosis treatment 
programs across the United States through a 5 percent set-aside 
(approximately $25 million) within SAMHSA's MHBG program. This 
initiative is now continuing into 2015. SAMHSA and NIMH are working 
collaboratively on the implementation of this set-aside funding within 
MHBG, including on the dissemination of RAISE materials, webinars, 
presentations, and staff trainings.
    In 2013, only 16 States had one or more coordinated specialty care 
clinics; by September 30, 2015, we estimate that 27 States will have at 
least one coordinated specialty care clinic as a result of the MHBG 
set-aside opportunity.
    In Missouri, Burrell Behavioral Health, a non-profit community 
mental health organization, participated in the RAISE Early Treatment 
Program study between 2010 and 2014. Experience as a RAISE site was a 
critical factor in developing Missouri's response to the MHBG set-aside 
opportunity. Missouri is using its MHBG set-aside funds to implement a 
coordinated specialty care program for first-episode psychosis in its 
Southwest Block Grant Planning Region. The Burrell facility in 
Springfield, Missouri was selected to implement this new coordinated 
specialty care program, due in part to its successful experience in the 
RAISE Early Treatment Program study.
    implementation of the child care and development block grant act
    Question. Last year Congress overwhelmingly passed a 
reauthorization of the Child Care and Development Block Grant (CCDBG) 
Act. Before this reauthorization, the Administration was proposing 
administrative reforms to do many of the same things. Does the 
Administration have an estimate of how much it will cost States to 
implement the changes in the CCDBG Reauthorization Act?
    Answer. ACF is currently gathering information and input from 
States and other stakeholders, particularly around the cost of 
implementing the Child Care and Development Block Grant (CCDBG) 
reauthorization legislation, including provisions that improve 
continuity of care, strengthen health and safety standards, mandate 
comprehensive criminal background checks, and require annual 
monitoring. The Administration has requested $266 million in CCDBG 
discretionary funding as part of the fiscal year 2016 Budget to help 
States begin to implement the new law.
    The fiscal year 2016 Budget also includes $82 billion in additional 
mandatory funding over 10 years to ensure that all low- and moderate-
income working families (under 200 percent of the Federal Poverty 
Level) with children under age four have access to child care 
assistance that can help them afford high-quality care. By 2025, this 
investment will provide access to quality care for about 1.15 million 
additional children under the age of four each year, increasing the 
total Child Care and Development Fund caseload to a historic high of 
over 2.6 million children. This mandatory investment also includes 
funding to maintain access for about 1.5 million children as States 
implement the changes required by the CCDBG reauthorization. At the 
same time, this new funding will raise the quality of care for young 
children currently in care by closing the gap between the low subsidy 
provided in many child care programs today and the high cost of quality 
infant and toddler care.
    children's hospitals graduate medical education payment program
    Question. Currently, the Children's Hospital Graduate Medical 
Education program provides approximately 45 percent of the funds 
necessary to train a physician in pediatric care. The President's 
budget request reduces funding for this program by 62 percent, 
jeopardizing this critical training. What is the justification for this 
significant reduction that only pays for direct costs?
    Answer. The fiscal year 2016 Budget proposals for graduate medical 
education target the investments where they are needed most--in primary 
care (including pediatrics) and certain specialties--and to encourage 
practice in rural and other underserved areas.
    Direct medical education spending includes expenditures related to 
stipends and fringe benefits for residents; salaries and fringe 
benefits of supervising faculty; costs associated with providing the 
graduate medical education training program; and allocated 
institutional overhead costs. Indirect medical education spending 
includes expenditures associated with the treatment of more severely 
ill patients and additional costs associated with the teaching of 
residents, such as reduced productivity of the hospital staff because 
they are helping train residents and the processing of additional 
diagnostic tests that residents may order during their clinical 
experience. The Budget includes $100 million in discretionary funding, 
despite tight budgetary constraints, for the Children's Hospitals 
Graduate Medical Education program to fully support direct medical 
education expenses at children's hospitals. The Budget prioritizes 
funding for direct medical education over indirect medical education 
expenses because of the fact that indirect costs are not well-
documented; studies released by MedPAC and other experts indicate that 
indirect medical education costs may be overstated in certain programs.
    The Budget also proposes a new $5.25 billion program (Target 
Support for Graduate Medical Education) that would expand funding for 
residency training in primary care or other high-need specialties, 
including in pediatrics. Children's hospitals would also be eligible to 
compete for additional funding under this proposal.
    Question. Why is the Department opposed to training more physicians 
in pediatric care and specialty care?
    Answer. We support funding for medical residency training programs 
for pediatric and specialty care, and are committed to working with 
Congress to make sure our training hospitals have the resources they 
need to develop a strong workforce. The funding requested for the 
Targeted Support for Graduate Medical Education program provides an 
opportunity for the Children's Hospitals Graduate Medical Education 
programs and other entities to compete for additional funding to 
support pediatrics and other high-need specialty residency programs (a 
total of 13,000 residents over 10 years).
                   fiscal year 2016 budget priorities
    Question. The Department's overall request reflects an increase of 
$4.4 billion. This increase is far greater than anything the Committee 
could possibly provide within the constraints of the Budget Control 
Act. Given that it is difficult to discern your priorities with a 
request that breaks the budget caps, can you discuss what, 
specifically, are the Department's highest discretionary priorities in 
fiscal year 2016?
    Answer. The Department's fiscal year 2016 Budget proposes $83.8 
billion in discretionary budget authority, an increase of $4.8 billion 
from fiscal year 2015 appropriations. This additional funding will 
allow the Department to make the investments that are necessary to 
serve the millions of American people who count on our services every 
day, while laying the foundation for healthier communities and a 
stronger economy for the middle class in the years to come. The Budget 
also further strengthens the infrastructure needed to prevent, prepare 
for, and respond to future challenges effectively and expeditiously.
    The Department's Budget request recognizes our continued commitment 
to balancing priorities within a constrained budget environment through 
legislative proposals that, taken together, would save the American 
people a net estimated $228.2 billion in HHS programs over 10 years. 
The Budget builds on savings and reforms in the ACA with additional 
measures to strengthen Medicare and Medicaid, and to continue the 
historic slow-down in healthcare cost growth. Medicare proposals in our 
Budget, for example, more closely align payments with the costs of 
providing care, encourage healthcare providers to deliver better care 
and better outcomes for their patients, improve access to care, and 
create incentives for beneficiaries to seek high value services. In 
order to achieve these goals, it is critical that Congress fully fund 
the Department's fiscal year 2016 Budget request.
                    hhs' communications expenditures
    Question. Please provide a year-by-year summary of marketing and 
advertising expenses for the Department over the last three fiscal 
years, including the primary programs involved in such marketing 
activities and their primary objectives?
    Answer. HHS is responsible for promoting transparency, 
accountability and access to critical public health and human services 
information to the public, media, and constituency groups. Many of the 
Department's communications efforts are embedded in agency operating 
budgets and program operations, so a breakout of HHS-wide 
communications activity will take time to compile. HHS will work with 
Committee staff to provide this information.
    The Office of the Secretary's primary objectives include 
communicating the Department's mission, critical initiatives, and other 
activities to the general public through various channels of 
communication; and promoting transparency, accountability, and access 
to critical public health and human services information to the 
American people.

                               OFFICE OF THE SECRETARY COMMUNICATIONS EXPENDITURES
----------------------------------------------------------------------------------------------------------------
                                                                            Fiscal Year
                                                 ---------------------------------------------------------------
                                                       2013            2014            2015            2016
----------------------------------------------------------------------------------------------------------------
Communications..................................     $12,214,168     $11,647,765     $12,447,816     $15,890,147
Travel (Outreach)...............................          30,908          63,659          90,000          77,500
    Total.......................................     $12,245,076     $11,711,424     $12,537,816     $15,967,647
----------------------------------------------------------------------------------------------------------------
Includes all funding sources, GDM, ACA, SSF, and individual reimbursable agreements.

                             serco contract
    Question. There have been recent articles highlighting that Serco 
employees are playing games, reading, or doing nothing at all at the 
expense of taxpayers. Are these allegations true and what oversight is 
CMS providing to ensure taxpayer dollars are responsibly used?
    Answer. CMS takes seriously any issues involving our contractors, 
works quickly to address them, and holds them accountable. Over the 
last year, CMS has put in place additional measures to monitor Serco's 
performance and worker productivity, and Serco's employees have been 
cross-trained in multiple tasks to gain additional flexibility and to 
be as efficient as possible. CMS continues to work with Serco to 
monitor staffing levels and productivity so staffing can be adjusted.
    durable medical equipment, prosthetics, orthotics and supplies 
                      competitive bidding program
    Question. In November 2014 CMS published Final Rule 1614-F. This 
rule mandates that CMS use the knowledge it gleaned from the 
competitive bidding program for durable medical equipment, prosthetics, 
orthotics and supplies (DMEPOS) to adjust the fees Medicare pays for 
certain items in geographic areas not covered by the competitive 
bidding program. Within a geographic area of competitive bidding only 
those winning bidders are allowed to service Medicare beneficiaries. 
Clearly, anyone bidding under such a scenario would have an assumption 
that suppliers awarded competitive bidding contracts would have access 
to a greater volume of business. As such, it is logical to assume that 
they might be willing to accept a lower payment rate in return for 
higher volume. Providers of these items and services in non-bid areas 
cannot have such an expectation since any adjustment to the payment 
rates in non-bid areas does not reduce competition. Adjustments to 
reimbursement rates in non-bid areas must consider multiple factors 
including the cost of doing business in a specific geographic area, the 
existing provider landscape and their ability to service the needs of 
the market, and the data CMS has collected from its competitive bidding 
program. Why is CMS only using only competitive bidding pricing 
information?
    Answer. I understand that CMS has been monitoring access and health 
outcomes data of various types of beneficiaries in the competitive 
bidding areas, i.e., beneficiaries who have a claim for the product in 
the month of observation or any of the previous 3 months and patient 
access groups (beneficiaries with medical conditions that might warrant 
use of a particular device). CMS has found that payment based on the 
DMEPOS competitive bidding program has not reduced access to or quality 
of these items and services. In addition, CMS has not seen any negative 
impacts since the initial programs, contracts, and payment amounts took 
effect on January 1, 2011.
    CMS will be closely monitoring the impact of the reductions to the 
fee schedule amounts to determine the extent to which suppliers 
continue to accept the new amounts as payment in full in all areas 
where the adjusted fee schedule amounts are used in paying claims. This 
information, in addition to information on health outcomes in these 
areas, will allow CMS to assess whether reducing the amounts is causing 
any negative impacts for CMS beneficiaries.
    As your question alludes to, Sections 1834(a)(1)(F)(ii) and (iii) 
of the Social Security Act requires that payment information be used 
under the competitive bidding program to adjust the fee schedule 
amounts for covered items of Durable Medical Equipment in all non-
competitive bidding areas beginning January 1, 2016. Additionally, we 
are required to continuing to make such adjustments to the fee schedule 
amounts as additional covered items are phased in or information is 
updated as new contracts are awarded. CMS issued a final rule in 
November 2014 that sets forth a methodology for adjusting fee schedule 
payments using information from the Competitive Bidding Program as 
required by statute.
    Question. Congressional intent of the Medicare Improvements for 
Patients and Providers Act (MIPPA, 2008) was clearly and specifically 
to exclude complex rehabilitation wheelchairs and accessories from 
Competitive Bidding because access issues would occur as a result of 
such reimbursement cuts. This intent was reinforced in a letter 
recently sent to Acting Administrator Slavitt by 100 members of the 
House of Representatives. We understand that CMS, through final rule 
1614-F, intends to cut reimbursement rates for complex rehabilitation 
items, despite Congressional intent. What rationale or justification is 
CMS using to oppose Congressional intent and cut the reimbursement for 
complex rehab wheelchairs and accessories?
    Answer. CMS excluded Group 3 or higher complex rehabilitative power 
wheelchairs and related accessories furnished in connection with such 
wheelchairs from the competitive bidding programs as required by MIPPA. 
These items are not included in any competitive bidding programs in 
effect today, and suppliers do not need to compete for contracts for 
furnishing Group 3 or higher complex rehabilitative power wheelchairs 
and related accessories.
    However, Section 1834(a)(1)(F)(ii) of the Social Security Act 
mandates adjustments to the fee schedule amounts for durable medical 
equipment (DME) based on information from the competitive bidding 
programs. CMS is now establishing more reasonable payment rates for 
these items and services based on information related to the current 
costs of furnishing these items and services.
    A rule addressing this topic, which was issued in November 2014 (79 
FR 66120; CMS-1614-F),finalized a policy that the fee schedule amounts 
for accessories used with different types of base equipment included in 
competitive bidding programs would be adjusted based on information 
from the competitive bidding programs. The Healthcare Common Procedure 
Coding System (HCPCS) codes that describe wheelchair accessories are 
used interchangeably on different wheelchair bases. For example, a U1 
sealed lead acid battery is the same battery regardless of whether it 
is used on a standard power wheelchair or a complex rehabilitative 
power wheelchair. CMS will be using information from the competitive 
bidding program to adjust the fee schedule amounts for these types of 
HCPCS codes.
    CMS also established a phase-in for the adjustments from January 1, 
2016, through June 30, 2016, based on 50 percent of the non-adjusted 
fee schedule amounts and 50 percent of the adjusted fee schedule 
amounts. This approach will allow a 6-month transition period where CMS 
can closely monitor health outcomes data and issues related to access 
to quality items and services at these lower payment amounts.
                        missouri medicaid audit
    Question. The Department of Health and Human Services Inspector 
General recently conducted an audit in Missouri and found that in a 
number of cases Medicaid rebates were not collected properly through 
the Medicaid Drug Rebate Program. The audit states that Missouri owes 
$34 million to the Federal Government--which is the entire cost of the 
drugs rather than the amount not collected through the rebate, which is 
$7 million. Can you explain why Missouri would owe the entire cost of 
the drug and not just the amount they failed to collect?
    Answer. As you noted, the Office of Inspector General (OIG) 
examined the extent to which Missouri complied with Federal Medicaid 
requirements for billing manufactures for rebates for physician-
administered drugs. The Centers for Medicare & Medicaid Services (CMS) 
is currently reviewing the OIG audit to gain an understanding of the 
findings, recommendations and State response. CMS follows a 
deliberative process for conducting an independent assessment of the 
OIG report and findings to ensure that CMS is recovering Federal funds 
appropriately.
                      ryan white hiv/aids program
    Question. How many ACA enrollees also receive coverage under Ryan 
White?
    Answer. The Ryan White HIV/AIDS Program data systems collect data 
on the individuals living with HIV/AIDS served by the program, 
including their insurance status. Many Ryan White HIV/AIDS Program 
clients are newly-eligible for coverage under the federally-facilitated 
Marketplace, State-based or partnership marketplaces, or Medicaid 
expansion. At the end of 2015, data on insurance coverage for 2014, the 
first full year of ACA implementation, is anticipated to be available. 
However, while this information will provide the Department the number 
of Ryan White clients with healthcare coverage and will distinguish 
between types of coverage those individuals receive (e.g. Medicaid, 
Medicare, or private insurance), it will not be able to distinguish 
whether that coverage is the result of Medicaid expansion or ACA 
Marketplaces.
    The Department is working to understand the impact of the ACA on 
the Ryan White HIV/AIDS Program and the people it serves, as well as 
identify the types of medical and wrap-around services provided through 
the Ryan White HIV/AIDS Program that are not covered or fully covered 
by Medicaid, Medicare, and private insurance. For example, the Ryan 
White HIV/AIDS Program also provides oral healthcare, home healthcare, 
hospice services, medical case management, treatment adherence 
counseling, psychosocial support services, outreach and a host of other 
support services that are critical to identifying, linking and 
maintaining people living with HIV and AIDS in care, which may not be 
covered by the ACA insurance expansions or other insurance.
                     office of refugee resettlement
    Question. A comment letter was filed on February 20, 2015 by an 
array of faith-based organizations that provide caring services for 
populations like these: the Catholic bishops' migration and refugee 
services, World Relief, World Vision, National Association of 
Evangelicals, and Catholic Relief Services. They expressed concern that 
the Department's commitment to conscience rights is not found in the 
interim final rule, and they had specific concerns about the vagueness 
of the preamble. What steps are being taken to prepare a final rule 
that responds to those concerns?
    Answer. ACF released an interim final rule on standards to prevent, 
detect, and respond to sexual abuse and sexual harassment involving 
unaccompanied children. This rule comprehensively addresses the issues 
of sexual abuse and sexual harassment in Office of Refugee Resettlement 
(ORR) care provider facilities nationwide, and is particularly 
important, given the unaccompanied youth ORR serves. ORR is firmly 
committed to protecting children in its custody and treats reports of 
abuse or mistreatment seriously. The standards build upon existing 
State and local laws, regulations, and licensing standards.
    The interim final rule requires that, among other things, care 
provider facilities:
  --Properly assess and provide follow-up on case management to 
        unaccompanied children who have experienced prior sexual abuse, 
        including referrals to qualified medical and mental health 
        practitioners;
  --Provide unaccompanied children who are victims of sexual abuse 
        timely, unimpeded access to emergency medical treatment, crisis 
        intervention services, emergency contraception, sexual 
        transmitted disease prophylaxis, and ongoing medical and mental 
        health evaluations and treatment; and
  --Provide female victims of sexual abuse by a male abuser pregnancy 
        tests and timely information about and access to all lawful 
        pregnancy-related medical services.
    ACF is committed to continuing the strong partnership with the 
faith-based organizations that have been critical in delivering 
services to these vulnerable populations. ORR adheres to the ACF policy 
on grants to faith-based organizations (found online here http://
www.acf.hhs.gov/acf-policy-on-grants-to-faith-based-organizations). In 
instances where organizations have a conscience objection to 
requirements in the interim final rule, this policy suggests three 
specific ways of addressing objections. These are:
  --Serve as subgrantees: In many cases, subgrantees do not need to 
        provide every service for which the grantee is responsible as 
        long as the grantee ensures that their overall program provides 
        all required services.
  --Apply in a consortium: As long as all clients of the consortium 
        have timely access to all required services, a consortium may 
        be able to divide responsibility for providing those services 
        consistent with each member's principals.
  --Notify grantor: In some circumstances, the grantee can notify the 
        Federal office responsible for the grant if a client's needs or 
        circumstances may require services, including referrals, to 
        which the organization has a religious objection. It would then 
        be the Federal agency's responsibility to follow through with 
        the needed service, or transfer the case to another provider.
    The policy says that ACF will consider any combination of these 
approaches and ACF specifically requested comment on other approaches 
that would accomplish the goal of ensuring that people have access to 
the full range of services while enabling qualified faith-based 
organizations to participate in the delivery of those services in a 
manner consistent with their principals.
    The interim final rule was open for public comment through February 
23, 2015 and ACF is actively reviewing comments that were received and 
uploading them onto www.regulations.gov. ACF is carefully considering 
all comments and is planning to publish a final rule later this year.
                    u.s. domestic response to ebola
    Question. Moving forward, what's the plan?
    Answer. HHS has played a critical role in the U.S. Government 
response to the largest Ebola outbreak in history. Thanks to Congress, 
a total of $2.8 billion in emergency funding is strengthening the 
Department's ongoing response to control the Ebola virus outbreak. HHS 
is working with U.S. Government partners and the international 
community to ensure that the global response is coordinated and 
resources are allocated in a way that will improve our capacity to 
manage future outbreaks. Domestically, States and hospitals have 
played, and will continue to play, an important role in the ongoing 
domestic Ebola preparedness and response efforts.
    As of April 22nd, HHS has obligated a total of $464 million of the 
Ebola emergency funding. This funding is supporting specific activities 
domestically and internationally to improve the detection, prevention, 
and response to Ebola and other outbreaks by developing new medical 
countermeasures and strengthening public health and healthcare 
infrastructures. With input from the public health and hospital 
communities, the Department has developed a framework for a tiered 
approach for the U.S. healthcare system, which outlines the different 
roles facilities play in preparing to identify, isolate, evaluate, and 
treat possible Ebola patients. Building upon that framework the 
Department is working to establish a nationwide, regional treatment 
network for Ebola and other infectious diseases. This network will 
balance geographic need, differences in institutional capabilities, and 
account for the potential risk of needing to care for an Ebola patient. 
Additionally, the Department has established a claims process for 
reimbursement of treatment and transportation costs for those providers 
who have treated Ebola patients. Through the Biomedical Advanced 
Research and Development Authority and the National Institutes of 
Health, the Department is supporting Ebola vaccine and therapeutics 
efficacy clinical trials internationally, as well as similar safety 
trials domestically.
    HHS is moving aggressively to manage the Ebola outbreak in West 
Africa. Ongoing collaboration is occurring with international partners 
to optimize alignment of policy and planning moving forward. CDC is 
focused on ending the epidemic in West Africa, assessing the needs of 
countries at greatest risk for importation, and developing plans for 
building their capacity to prevent, detect, and respond today and in 
the future. Currently, CDC has plans in place for $1.2 billion in 
international response and preparedness and Global Health Security 
Agenda implementation, and continues to monitor the situation in West 
Africa and will adjust that plan accordingly if the situation changes. 
These funds will support networks in West Africa, and other parts of 
the world, to prevent an outbreak of this magnitude from happening 
again
    From lessons learned in the initial evaluation of the Ebola 
response, the fiscal year 2016 Budget includes a new proposal for $110 
million to support flexibility for immediate emergency response 
efforts. These funds would be available for quick response to emerging 
public health crises which are not eligible for Stafford Act funding 
and for instances where a sufficient emergency supplemental has not yet 
been provided. Funds could be used for activities such as the rapid 
deployment of epidemiologists; emergency response activities; purchase 
of countermeasures; and State and local response. This funding would 
bolster the Nation's capacity to plan for and manage the response to 
public health emergencies, including outbreaks of infectious disease 
that may require both domestic and international response capabilities.
   u.s. international response to ebola in sierra leone, guinea, and 
                                liberia
    Question. How will we address the three countries Ebola recovery 
plans?
    Answer. The Ebola epidemic has highlighted the importance of every 
country having core public health capacities in place to protect the 
health and safety of their people. Our first commitment to Liberia, 
Guinea, and Sierra Leone is to get to zero and stay at zero cases of 
Ebola. Going forward, we will be working with the three affected 
countries to identify the priority areas for recovery. These plans will 
be country-driven, and supported by technical assistance from CDC and 
other agencies. We are currently working with these countries to assess 
their public health systems to find out how they have been impacted, 
where there are gaps, and how to prevent future outbreaks and return 
public health services to the public. Public health system recovery in 
these countries will focus on how we prevent future infectious disease 
threats (by improving systems to prevent, detect and respond) as well 
as assisting in the re-establishment of public health services 
including maternal and child health, immunization, malaria prevention, 
as well as water and sanitation. Within 2015, CDC offices will be 
established in each of the three countries to engage with the 
Ministries of Health; cooperative agreements are being established to 
provide funding from CDC to Ministries of Health and partners for 
significant ongoing activities; and staff will be put in place to 
support ongoing operations.
                      aca state innovation waivers
    Question. Recognizing that this authority is not available until 
2017, has HHS taken any actions in advance for utilizing this authority 
under the ACA?
    Answer. Final regulations \3\ published jointly by the Department 
of Health and Human Services and the Department of Treasury in February 
2012 provided States with guidance about how to apply for a voluntary 
waiver under this authority. The final regulations set forth a process 
for States to submit applications and describe what an application from 
a State must contain. The regulation outlines how public notice and 
comment will work, including public hearings, to ensure a meaningful 
level of public involvement, input, and transparency. These 
requirements were designed to coordinate with the section 1115 
requirements, which were published on the same day. Finally, the 
regulations describe the requirements for post-award reporting and the 
standards under which post-award monitoring will take place.
---------------------------------------------------------------------------
    \3\ Federal Register, Vol. 77, No. 38, February 27, 2012, 
Application, Review, and Reporting Process for Waivers for State 
Innovation, http://www.gpo.gov/fdsys/pkg/FR-2012-02-27/pdf/2012-
4395.pdf.
---------------------------------------------------------------------------
    Question. If HHS intends to use this provision in the future, what 
are some of the ideas for implementing it?
    Answer. Section 1332 of the Affordable Care Act gives States the 
option to seek a State innovation waiver to pursue their own innovative 
strategies to improve healthcare for their residents while retaining 
the financial protections and insurance coverage achieved by the 
Affordable Care Act. The Department of Health and Human Services is 
committed to working with States that express interest in applying for 
a State innovation waiver.
                 acl's fiscal year 2016 budget request
    Question. ACL's request for 2016 places significant emphasis on the 
deployment of evidence-based programs and strategies. What is the 
Administration's recent history with the identification and 
dissemination of evidence-based programs to help older adults manage 
chronic diseases and prevent falls and their return on investment, 
particularly related to health costs?
    Answer. The Administration has a long history of identifying and 
disseminating cost-effective evidence-based programs to help older 
adults manage their chronic diseases and/or prevent their risk or fear 
of falling. This experience includes (1) administering formula grants 
that must be used only to fund evidence-based programs, (2) awarding 
and administering discretionary grants for evidence-based chronic 
disease self-management education programs, (3) awarding and 
administering discretionary grants for evidence-based falls prevention 
programs, (4) awarding and administering grants that expand the 
availability of evidence-based interventions and dementia-capable long 
term services and supports systems, and (5) managing a rigorous program 
that evaluates the strength of the evidence behind evidence-based 
programs.
    The Administration on Aging, now a part of the Administration for 
Community Living, has managed Title III-D of the Older Americans Act, 
titled Disease Prevention and Health Promotion Services, since 1987. 
This effort provides formula grants to States and Territories based on 
their share of the population aged 60 and over to educate older adults 
about the importance of healthy lifestyles and promote healthy 
behaviors. These programs can help to prevent or delay chronic disease 
and disability, thereby reducing the need for more costly medical 
interventions. In fiscal year 2012, ACL requested and Congress enacted 
appropriations language requiring States to use these funds only to 
support proven evidence-based models that enhance the wellness and 
fitness of the aging community. The same language has been included in 
each subsequent year's appropriation's language, and is also included 
in the language proposed for fiscal year 2016. Since the enactment of 
this language, ACL has provided guidance to States regarding what meets 
the evidence-based requirement. ACL developed a three tiered set of 
criteria for defining evidence-based interventions that can be funded 
with Title III-D funds. For now, States can use funds for programs that 
meet any of the three levels of evidence. Starting with fiscal year 
2017 funds, States can only fund evidence-based programs that meet the 
highest level of evidence. ACL also provides a cost-chart that lists 
some of the more common evidence-based programs for States' use, and 
promote the use of CDC's Compendium of evidence-based programs.
    Second, building on ACL's history of supporting evidence-based 
programs with Recovery Act funds, ACL awarded 22 grants using the 
Prevention and Public Health Fund to continue these activities. These 
3-year grants (now in their third year) are enabling States to provide 
chronic disease self-management education programs to over 80,000 
adults to help them better manage chronic conditions. The funding is 
not only increasing access to chronic disease self-management education 
programs, but also fostering the development of comprehensive, 
integrated delivery systems to embed and sustain these programs within 
the long-term supports and services and healthcare systems.
    Third, ACL funds falls prevention programs that provide evidence-
based programs to help older adults and adults with disabilities 
prevent falls and reduce their fear of falling, which is a significant 
risk factor for actually falling. ACL currently funds ten grants to 
States and four grants to tribes for falls prevention programs using 
PPHF funding.
    Fourth, ACL has years of experience with evidence-based programs 
and systems that have been proven to help individuals with Alzheimer's 
disease and their caregivers. These systems are able to identify those 
with dementia and their family caregivers, understand their unique 
circumstances, communicate appropriately with them, help them choose 
services that meet their needs, and provide supports to ease caregiver 
stress. The most recent grant projects are designed to ensure that 
States provide people with dementia and their family caregivers with 
access to a sustainable home and community-based services system that 
is dementia capable. There are presently fifteen States engaged in 
projects dedicated to the implementation of dementia-capable services.
    Finally, recognizing that the development of evidence-based 
programs is ongoing, ACL has invested in an Aging and Disability 
Evidence-Based Program and Practices review process that consists of a 
rigorous review of evidence-based interventions involving two panels of 
independent expert reviewers. One set of reviewers assess and rate the 
quality of research; the other reviewers rate the program on readiness 
for dissemination. Intervention summaries are made available on ACL's 
website. Aging and Disability Evidence-Based Program and Practices is 
one way that ACL is working to improve access to information on 
evaluated interventions and reduce the lag time between the creation of 
scientific knowledge and its practical application in the field.
    These programs are effective and save healthcare costs. One example 
of an evidence-based intervention is the New York University Caregiver 
Intervention, a spousal caregiver support program that in a randomized-
control trial delayed institutionalization of persons with dementia by 
an average of 557 days. Minnesota has translated this intervention and 
results are consistent with the original study. In addition, in 2013, 
CMS published a Report to Congress that retrospectively examined pre 
and post Medicare claims costs for participants in various evidence-
based programs that ACL funds. As described in the report, there were 
statistically significant total Medicare medical cost savings for the 
following programs: EnhanceFitness, Arthritis Foundation Exercise 
Program, Arthritis Foundation Tai Chi Program, and Matter of Balance (a 
falls risk reduction program). The Chronic Disease Self-Management 
Program from Stanford, which is provided by ACL's Chronic Disease Self-
Management grants, showed savings in Medicare inpatient hospital costs.
              funding for acl's family support initiative
    Question. How does this experience translate into the 
Administration's requests for a Family Support Initiative and 
modernizing senior nutrition programs?
    Answer. The ACL Family Support initiative arose from three 
motivations: a national crisis in the need for unpaid family caregiving 
that will be exacerbated by the aging of the baby boomer generation; 
the recognition that families can draw on and leverage local resources 
more effectively with better support, information and coordination, 
thus reducing their dependence on public programs; and a recognition 
that ACL can expand the experience with developing and maintaining 
evidence-based programs in the aging policy arena to family supports 
for people with disabilities. The intent of the Family Support proposal 
is to build on the success of existing programs that were developed and 
implemented under the Administration on Aging, requiring State 
applicants to leverage these existing resources, build partnerships 
across State agencies and link with private resources as well, 
utilizing community assets that are available to all citizens in the 
community. The goal is to create a comprehensive system to support 
family caregivers in the State that is demographically, economically 
and culturally appropriate for that State, providing the three prongs 
of support that research has identified as crucial: knowledge, training 
and skill development; emotional and social supports; and goods and 
services, as needed. In addition, ACL proposes to require States to 
conduct rigorous evaluations, including the use of rapid cycle 
learning, to make adjustments to their programs to most effectively and 
efficiently meet the needs of families within the constraints of State 
resources. The requirements for evaluation and data collection would 
enable ACL to build an evidence base to support our proposed approach.
    On the nutrition front, ACL is committed to working with State and 
local partners to modernize these services and to ensure that every 
dollar is spent effectively. As noted in the ACL budget justification, 
research clearly shows that providing nutrition services improves the 
health of participants and reduces their need for more expensive 
medical interventions and institutional care. Translating the knowledge 
generated by this research into evidence-based models for delivering 
services at the community level is essential to ensuring the continued 
efficacy of these programs and improving their efficiency. ACL will 
build on past experience in evidence-based program development and 
dissemination to help to prepare these programs to meet the changing 
demands of seniors as the baby boom generation ages, with priorities to 
include modernization of infrastructure and delivery systems, 
increasing meal and service quality, the use of new technology to 
improve efficiency and communication, and the development of innovative 
linkages between nutrition sites and health promotion activities.
                                 ______
                                 
               Questions Submitted by Senator Jerry Moran
                       critical access hospitals
    Question. I would like to talk about an issue I have raised in 
previous HHS hearings over the past few years--the importance of 
Critical Access Hospitals and the proposed cuts to these hospitals 
contained in the President's 2016 budget request. Again, there are two 
specific changes proposed by the President's budget, reducing cost 
based reimbursement from 101 percent to 100 percent and changing the 
rules to eliminate CAH designations for those hospitals within 10 miles 
of another hospital.
    I am sure you are aware that rural hospitals across the country are 
struggling to remain open and financially viable. Since 2010, 50 
hospitals have closed and 283 are on the brink of closure. Currently, 
nearly 38 percent of Critical Access Hospitals are operating at a loss. 
A study by Health Affairs shows that if these changes are implemented 
that percentage will double to more than 75 percent. At the same time, 
Critical Access Hospitals account for only 5 percent of Medicare 
inpatient and outpatient payments. So, these policy changes would 
result in relatively nominal budgetary savings, but come at a huge cost 
to rural patients and their communities.
    Given the serious challenges these polices would create for many 
rural hospitals, are you concerned about how they would affect access 
to healthcare for Americans living in rural communities?
    Answer. I am committed to supporting rural America and putting 
policies into place that strengthen rural communities. The proposals in 
the President's Budget are carefully targeted to generate savings for 
the Medicare program without any significant adverse impact on rural 
access to care. Limiting Critical Access Hospital (CAH) designation to 
facilities located within ten miles of the nearest hospital will ensure 
that only facilities whose communities depend upon that facility alone 
for emergency and basic inpatient care will be designated as CAHs and 
receive cost-based reimbursement. CMS conducted an analysis of the 
impact of this proposal on access to services in rural communities.\1\ 
The analysis estimated that a maximum of 47 CAHs, out of a total of 
1,339 certified CAHs, might be affected by this proposal. Moreover, 
facilities losing their CAH designation would not necessarily close. 
Instead, it is anticipated that many of these CAHs would continue to 
participate in Medicare as hospitals paid under the applicable 
prospective payment system, and would continue to provide hospital 
services to their communities without reliance on CAH designation. 
Hospitals that transitioned from their CAH status would be eligible for 
the Hospital Value-based Purchasing Program, which provides financial 
incentives for high quality of care and improvement in quality.
---------------------------------------------------------------------------
    \1\ Centers for Medicare and Medicare Services, Report on Critical 
Access Hospitals, March 26, 2015.
---------------------------------------------------------------------------
    In the event that some of the potentially affected CAHs were to 
close, CMS analysis found that there likely is sufficient capacity in 
nearby facilities to provide the services any closed CAH had previously 
provided. CMS conducted an analysis of recent Medicare and cost report 
data for the potentially affected CAHs, as well as for the hospitals 
located within 10 miles of these CAHs. Overall, the data suggests that 
there would be no significant issues related to access to inpatient 
acute care services or skilled nursing services for the communities 
currently being served by the potentially affected CAHs should the CAH 
cease to provide services rather than convert its Medicare agreement to 
participate as a hospital. Additionally, HHS will continue to monitor 
rural communities to ensure that access to medical care is preserved.
    The President's fiscal year 2016 Budget also proposes changing 
reimbursement of CAHs to pay them for their actual costs of providing 
care. This change would generate savings to the Medicare program while 
protecting access to care by reimbursing CAHs for 100 percent of their 
costs.
    Question. Rural hospitals across the country, including those in 
Kansas, are facing an ever-increasing amount of Federal regulatory 
challenges--including meeting the direct supervision requirements for 
outpatient therapeutic services and keeping pace with their urban 
counterparts in meeting all of the requirements of the Medicare and 
Medicaid Electronic Health Care Record Incentive Programs. At the same 
time, the President has repeatedly called for cuts to Critical Access 
Hospitals in his budget requests, which are often one of the only 
sources of healthcare services in a community. Do you think your 
Department is doing all it can to make sure rural communities maintain 
access to necessary healthcare services that are vital to their 
survival and success?
    Answer. As you know, being from a small town in West Virginia, 
rural health is an important priority for me. I am personally committed 
to and focused on supporting the health of rural communities.
    CMS has a number of efforts to improve access to services for rural 
Medicare beneficiaries. CMS has rural health coordinators at each of 
our Regional Offices, who meet monthly with participation from CMS 
central office staff and the Health Resources and Services 
Administration (HRSA) to discuss emerging issues. Through the Rural 
Health Open Door Forum, CMS engages with stakeholders to provide 
current information on CMS programs, answer questions, and learn about 
emerging rural health issues. Through Medicare's telehealth benefit, 
Rural Health Clinics, and Critical Access Hospitals (CAHs), CMS is 
making sure that rural beneficiaries have access to physician and 
hospital services that may not otherwise be available in their 
communities. Moving forward, the Center for Medicare and Medicaid 
Innovation is testing new payment and service delivery models such as 
Accountable Care Organizations (ACOs) with a focus on how to explore 
and support efforts to make further strides in improving the quality of 
care in rural areas.
    A key focus of the Department is to increase access for rural 
Americans to a healthcare provider through health professional training 
programs. In fiscal year 2014, the Health Resources and Services 
Administration (HRSA) provided rural health exposure to students 
through 11,389 training sites in rural communities. In addition, HRSA's 
primary care, oral health, geriatrics, public health and behavioral 
health training grants supported 180,401 students from rural areas. The 
National Health Service Corps supports loan repayment and scholarships 
for primary care providers, with almost half of the participants 
serving in rural areas. As of September 30, 2014, 3,529 National Health 
Service Corps members, or 44 percent of the National Health Service 
Corps field strength, were working in rural communities and 75 NHSC 
clinicians were working at CAHs. Half of the nearly 5,000 active NHSC-
approved sites are located in rural communities.
    Rural communities have also benefited from the collaborative work 
of the White House Rural Council, which was created in July 2011. The 
Council is focused on enhancing the ability of Federal programs to 
serve rural communities through collaboration and coordination. For 
instance, through the work on the Council, HRSA expanded eligibility 
for the National Health Service Corps Program to CAHs in 2012. This 
resulted in 229 CAHs being designated as service sites for National 
Health Service Corps clinicians. The Council also worked with CMS and 
HRSA to include a number of rural provisions in a Regulatory Burden 
Reduction regulation that take into account the unique practice 
environment for clinicians in rural areas; this regulation was 
finalized May 2014. Beyond encouraging collaborations among Federal 
agencies, the Council initiated a public-private partnership with 
approximately 50 private foundations and trusts that focus on improving 
rural healthcare.
    Question. There is a clear push to move away from fee-for-service 
medicine and towards quality and value in healthcare. This transition 
requires hospitals to make up-front investments in health equipment and 
technology. As we know, many Critical Access Hospitals operate on 
little to no margins, with limited resources to make capital 
investments. The cost based reimbursements these hospitals receive are 
essential to their operations budgets. How are these Critical Access 
Hospitals supposed to make these investments to facilitate future 
quality improvements when the Administration's proposals would mean 
more than three-fourths of these facilities would be operating at a 
loss?
    Answer. Since their creation, Critical Access Hospitals (CAHs) have 
provided needed hospital services to millions of Medicare 
beneficiaries. HHS is committed to preserving the CAH program and 
believes in ensuring that CAHs provide quality care to isolated 
communities without another nearby source of acute inpatient and 
emergency care. Last year, CMS finalized a rule that included reforms 
to Medicare regulations identified as unnecessary, obsolete, or 
excessively burdensome on hospitals and other healthcare providers, 
which will save nearly $660 million annually, and $3.2 billion over 5 
years. This rule specifically outlined ways to reduce burdens on rural 
healthcare providers. For example, a key provision reduces the burden 
on very small CAHs, as well as Rural Health Clinics and federally 
Qualified Health Centers, by eliminating the requirement that a 
physician be held to a prescriptive schedule for being onsite. This 
provision seeks to address the geographic barriers and remoteness of 
many rural facilities, and recognizes telehealth improvements and 
expansions that allow physicians to provide many types of care at lower 
costs, while maintaining high-quality care.
    CMS appreciates the unique challenges that rural providers may 
confront as they move more towards quality and value. The Innovation 
Center is uniquely positioned to test and evaluate efforts to identify 
and address challenges to access and quality of care for rural 
communities. The Innovation Center is testing two models designed to 
support Accountable Care Organizations (ACOs) in rural areas. The 
Advance Payment ACO Model is meant to help entities such as smaller 
practices and rural providers with less access to capital participate 
in the Medicare Shared Savings Program. The ACO Investment Model is a 
new model of pre-paid shared savings that builds on the experience with 
the Advance Payment Model to encourage new ACOs to form in rural and 
underserved areas, and to support these types of ACOs that are already 
participating in the Medicare Shared Savings Program.
            funding for the u.s. domestic response to ebola
    Question. Are the emergency Ebola funds that Congress appropriated 
building capacity to address the next emerging infectious disease 
crisis? Or, are these funds primarily being used to reimburse for 
expenses incurred since last summer?
    Answer. As of April 22nd, HHS has obligated a total of $464 million 
of the Ebola emergency funding. This funding is supporting specific 
activities domestically and internationally to improve the detection, 
prevention, and response to Ebola and other outbreaks by developing new 
medical countermeasures and strengthening public health and healthcare 
infrastructures. With input from the public health and hospital 
communities, the Department has developed a framework for a tiered 
approach for the U.S. healthcare system, which outlines the different 
roles facilities play in identifying, isolating, evaluating, and 
treating possible Ebola patients. Building upon that framework the 
Department is working to establish a nationwide, regional treatment 
network for Ebola and other infectious diseases. This network will 
balance geographic need, differences in institutional capabilities, and 
account for the potential risk of needing to care for an Ebola patient 
based on geographic proximity to a funneling airport or diaspora 
community. Additionally, the Department has established a claims 
process for reimbursement of treatment and transportation costs for 
those providers who have treated Ebola patients. Through the Biomedical 
Advanced Research and Development Authority and the National Institutes 
of Health, the Department is supporting Ebola vaccine and therapeutics 
efficacy clinical trials internationally, as well as similar safety 
trials domestically.
        lessons learned from the u.s. domestic response to ebola
    Question. What lessons have HHS and CDC learned from the Ebola 
outbreak to make sure State and local health departments are better 
prepared for the next emerging infectious disease outbreak?
    Answer. As of April 22nd, HHS has obligated a total of $464 million 
of the Ebola emergency funding. This funding is supporting specific 
activities domestically and internationally to improve the detection, 
prevention, and response to Ebola and other outbreaks by developing new 
medical countermeasures and strengthening public health and healthcare 
infrastructures. With input from the public health and hospital 
communities, the Department has developed a framework for a tiered 
approach for the U.S. healthcare system, which outlines the different 
roles facilities play in preparing to identify, isolate, evaluate, and 
treat possible Ebola patients. Building upon that framework the 
Department is working to establish a nationwide, regional treatment 
network for Ebola and other infectious diseases.
    From lessons learned in the initial evaluation of the Ebola 
response, the fiscal year 2016 Budget includes a new proposal for $110 
million to support flexibility for immediate emergency response 
efforts. These funds would be available for quick response to emerging 
public health crises which are not eligible for Stafford Act funding 
and for instances where a sufficient emergency supplemental has not yet 
been provided. Funds could be used for activities such as the rapid 
deployment of epidemiologists; emergency response activities; purchase 
of countermeasures; and State and local response. This funding would 
bolster the Nation's capacity to plan for and manage the response to 
public health emergencies, including outbreaks of infectious disease 
that may require both domestic and international response capabilities.
                    cdc immunization program funding
    Question. The President's fiscal year 2016 budget request contains 
a $50 million cut to immunization funding at CDC. Considering recent 
challenges such as the ongoing measles outbreak in many States, how 
will your Department make sure that local health departments have the 
resources to work with physicians and other healthcare providers to 
ensure high rates of immunization?
    Answer. As the recent measles outbreak demonstrates, immunization 
is a critical component of public health infrastructure. Through the 
Affordable Care Act, non-grandfathered private health plans are now 
required to cover recommended immunizations without cost-sharing, which 
has expanded access to this important service. Therefore, the Budget 
proposes less funding for the 317 immunization program to reflect 
coverage expansions that reduce the CDC resources needed for vaccine 
purchase, while providing the infrastructure and program support to 
maintain record high immunization rates.
    The majority of the reduction to the 317 program reflects reduced 
vaccine purchase. The Budget also maintains funding to recruit and 
educate networks of immunization providers; provide continual quality 
assurance; promote public awareness of new and expanded vaccine 
recommendations; manage vaccine shortages; and respond to vaccine-
preventable disease outbreaks. Since 2009, CDC has invested funding to 
expand the capacity of public health departments to bill health 
insurers for immunization services in order to expand access for fully-
insured individuals in areas where there is not adequate in-network 
provider coverage. In fiscal year 2016, CDC will continue to support 
the capacity of public health departments to bill health insurers for 
immunization services.
    In addition, the Budget increases funding for the Vaccines for 
Children program, a mandatory program that helps families access 
vaccines. The investment in the Vaccines for Children Program, taken 
together with CDC's discretionary 317 activities and coverage 
expansions through the Affordable Care Act, will provide vaccines and 
the program support to reach uninsured and underinsured populations.
    CDC will work collaboratively with its awardees and partners to 
establish access points at complementary venues such as schools, 
pharmacies, and retail-based clinics; expand the network of Vaccines 
for Children providers through recruitment efforts; purchase and 
deliver vaccine for at-risk populations; and ensure those with 
insurance have access to immunization services through an in-network 
provider.
                           home health claims
    Question. The Affordable Care Act includes a provision that 
requires a Medicare beneficiary to have a face-to-face encounter with a 
physician who certifies the need for that beneficiary's Medicare home 
health services. I understand that this provision aims to make sure 
Medicare beneficiaries are accurately being referred to the proper care 
setting, while also reducing the potential for waste, fraud and abuse. 
However, implementation of this face-to-face requirement has raised 
many concerns. The rules around what information physicians must 
document have been unclear and auditors who review the information have 
applied inconsistent and often conflicting standards on what is deemed 
``satisfactory.'' This has resulted in an unprecedented level of home 
health claim denials and a significant backlog of appeals. As this 
experience is extrapolated across the sector, I understand that we 
would expect the number of pending appeals to be in the thousands. In a 
high percentage of cases, face-to-face claim denials are overturned on 
appeal. In the meantime, continued unpaid claims--for care that is 
otherwise medically necessary--are making it hard for smaller home 
healthcare providers, particularly those in rural and underserved 
areas, to meet payroll and keep their doors open.
    Does your Department have a plan to establish more consistent and 
uniform auditing rules regarding home health claims?
    In the meantime, how does HHS expect to reduce the home health 
backlog that has resulted from the problems associated with 
implementation of the face-to-face policy?
    Answer. CMS simplified the face-to-face encounter documentation 
requirements by eliminating the specific face-to-face narrative 
requirement, in order to reduce administrative burden, and provide home 
health agencies with additional flexibility. CMS will use documentation 
from the certifying physician's medical records, and/or the hospital or 
post-acute facility's medical records, for beneficiaries as the basis 
for certification of home health eligibility. This simplification was 
finalized after public comment in the Calendar Year 2015 Home Health 
Prospective Payment System final rule (79 FR 66031). The use of the 
template is voluntary and CMS believes the use of clinical templates 
may reduce burden on the physicians and practitioners who order home 
health services.
    The majority of CMS contractors at the first and second level of 
the appeals process are processing appeals timely and do not have 
backlogs. Although there are backlogs at the third and fourth levels, 
we cannot separately calculate the home health appeals backlog or 
confirm that the face-to-face requirement is at issue in all of the 
pending home health appeals without manual reviews of the case files.
    The Department has a three-pronged approach to addressing the 
increasing number of Medicare appeals and the current backlog of claims 
to be adjudicated. First, invest new resources at all levels of appeal 
to increase adjudication capacity and implement new strategies to 
alleviate the current backlog. Second, take administrative actions to 
reduce the number of pending appeals and more efficiently handle new 
cases that are entering the appeals process. Third, pursue legislative 
proposals described in the President's fiscal year 2016 Budget that 
provide additional funding and new authorities to address this urgent 
need.
                recovery audit contractor program (racs)
    Question. In response to feedback from hospitals and healthcare 
providers, the Centers for Medicare & Medicaid Services are making 
several changes to the Medicare Recovery Audit Contractor (RAC) 
program. CMS has stated it is ``confident that these changes will 
result in a more effective and efficient program, by enhanced 
oversight, reduced provider burden and more program transparency.''
    On August 29, 2014, CMS presented an offer to hospitals to resolve 
backlogged claims appeals. The period for submitting an intent to 
participate ended on October 31, 2014. Although over 2,000 hospitals 
have entered the process, it is unknown how many hospitals will 
complete the process and choose to accept a global settlement offer. 
Judge Nancy Griswold, the Chief Administrative Law Judge for the Office 
of Medicare Hearings and Appeals, noted that, as of July 1, 2014, there 
were 800,000 pending ALJ RAC appeals. If all of these hospitals were to 
complete the global settlement process, how many claims would 
potentially be cleared from the RAC appeal backlog?
    Answer. HHS is still in the process of verifying and completing the 
review of the claims submitted for settlement. Upon completion, HHS can 
provide this information to the Committee. The Department has a three-
pronged approach to addressing the increasing number of Medicare 
appeals and the current backlog of claims to be adjudicated. First, 
invest new resources at all levels of appeal to increase adjudication 
capacity and implement new strategies to alleviate the current backlog. 
Second, take administrative actions to reduce the number of pending 
appeals and more efficiently handle new cases that are entering the 
appeals process. Third, pursue legislative proposals described in the 
President's fiscal year 2016 Budget that provide additional funding and 
new authorities to address this urgent need.
    The settlement provides an opportunity for the government to reduce 
the pending appeals backlog by resolving a large number of homogeneous 
claims in a short period of time. In addition, it allows hospitals to 
obtain payment now for rendered services, rather than waiting an 
extended period of time, with the additional risk of not prevailing in 
the appeals process.
    Question. On December 24, 2014, CMS announced another extension of 
the Part A/B RAC contracts until December 31, 2015, and on December 30, 
2014, the agency announced various program improvements that would 
become effective for the new RAC contracts. According to CMS, the 
December 30 announcement ``marks the beginning of the new Recovery 
Audit contracts and is the start date of the implementation of many 
improvements to reduce provider burden and increase transparency in the 
program.'' Some of these changes offer real improvements to the RAC 
process by limiting the scope and burden of the RAC reviews and 
adjusting RAC incentive structure to encourage quality and accuracy of 
initial RAC decisions, but the practical significance of the program 
enhancements will be driven by the establishment of specific standards 
by CMS, as well as CMS' ability to enforce the program changes. 
Additionally, due to the delays in awarding the new Part A/B RAC 
contracts, providers may not experience the implementation of these 
changes for months or even until 2016.
    Not all of CMS's proposed reforms would require contractual 
changes. For example, CMS could act today to provide audit relief to 
providers that have low error rates. Why doesn't CMS institute some of 
these reforms today without waiting for the new contracts, so these 
improvements can be implemented immediately?
    This Subcommittee directed CMS to work with providers to address 
this issue. Will your Department work with providers on implementation 
of these various improvements, to ensure that they achieve their 
intended effect of reducing provider burden and increasing 
transparency?
    Answer. CMS has announced a number of future changes to the 
Recovery Audit Program in response to industry feedback. In the process 
of procuring new contracts, these changes will result in a more 
effective and efficient program, including improved accuracy, less 
provider burden, and more program transparency. A comprehensive list of 
the Recovery Auditor program improvements can be found at: http://
www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/
Medicare-FFS-Compliance-Programs/Recovery-Audit-Program/Downloads/RAC-
Program-Improvements.pdf.
    In addition, CMS will continue to work with providers on 
implementation of the improvements to ensure they are having the 
desired effects.
                     cms' civil monetary penalties
    Question. Some skilled nursing facilities in Kansas have told me 
they have recently noticed a dramatic increase in the dollar amount of 
fines assessed by CMS when violations are reported. After discussing 
this matter with some SNF administrators in my State, I understand that 
CMS has altered its policies regarding the setting of such fines in an 
attempt to increase consistency across States and facilities. There are 
concerns that this new policy has created inconsistency of effect on 
various facilities. Fines are now at such an astronomical level that 
they cannot reasonably be paid by smaller nursing facilities that 
provide a critical community service in rural communities.
    For example, a county-owned and privately-operated facility in 
Kansas with capacity for 36 residents located in a town with a 
population of less than 1,300 is currently facing a fine in excess of 
$200,000. There may be situations where a fine this large is 
appropriate and necessary to compel a nursing facility to comply with 
regulations, but the facilities in my State are generally small, 
Medicaid providers who most likely do not have the ability to pay a 
fine of this magnitude. While I recognize the importance of correcting 
legitimate deficiencies, I am concerned about CMS levying such punitive 
fines on facilities that have no possible way to pay them and remain 
viable in the communities they serve.
    Can you explain why CMS has increased these fines so dramatically?
    Has CMS considered that the effect of fines of this magnitude will 
be to cause smaller nursing facilities to cease operation?
    Does CMS take into account the size and location of a facility when 
issuing correction plans and related fines for skilled nursing 
facilities? If so, please explain this process and the factors the 
agency considers in working with these facilities.
    Answer. CMS continues to evaluate policies and procedures 
pertaining to the imposition of CMPs and is evaluating data in regard 
to CMPs and other enforcement remedies. CMS has recently finalized 
guidance (known as the Civil Monetary Penalty (CMP) Analytic Tool) to 
promote more consistent application of enforcement remedies for skilled 
nursing facilities, nursing facilities, and dually-certified 
facilities. The CMP Analytic Tool is a guide CMS Regional Offices use 
to assess the appropriate type of CMP to be imposed and to calculate 
the baseline CMP amount for all new enforcement cases when the CMS 
Regional Office determines that a CMP is an appropriate enforcement 
remedy.
    Beginning on April, 1, 2013, CMS Regional Offices began piloting 
the CMP Analytic Tool. In an effort to monitor and evaluate the 
usefulness and effectiveness of this tool, Regional Offices were asked 
to submit feedback and based on this feedback, we found that the use of 
this Tool helped with nationally consistent application and imposition 
of CMPs.
    The purpose of the CMP Analytic Tool was not to increase fines; 
rather, the intent of the CMP Analytic Tool was to promote national 
consistency and to ensure all statutory and regulatory factors were 
taken into consideration in determining the CMP amounts. The CMP 
Analytic tool takes several factors into account. The factors include: 
scope and severity, past non-compliance, facility history of non-
compliance, number of deficiencies, repeat deficiencies, substandard 
quality of care, facility culpability.
    CMS also considers the financial ability of a facility to pay the 
fine. When determining the CMP amounts, CMS may or may not take into 
account the size and location of the facility, but does consider the 
facility's financial status.
                                 ______
                                 
              Questions Submitted by Senator Thad Cochran
        funding for the office for the advancement of telehealth
    Question. Secretary Burwell, the budget requests level funding of 
$14.9 million for the Office for the Advancement of Telehealth at the 
Health Resources and Services Administration. Though Mississippi is 
considered to have some of the best telehealth capabilities in the 
country, there is currently no grantee in the State of Mississippi. 
There are programs throughout the Department of Health and Humans 
Services that seem to need a reexamination of priorities. What can 
States like Mississippi do to ensure that they are able to access 
Federal funds across your Department for the advancement of their 
innovative healthcare models? What steps has the Department taken to 
level the playing field for States like Mississippi when it comes to 
competitive grants?
    Answer. The Center for Medicare and Medicaid Innovation in the 
Centers for Medicare & Medicaid Services supports the development and 
testing of innovative healthcare payment and service delivery models in 
different States and communities, including healthcare facilities in 
Mississippi. For example, thirty-three locations are participating in 
one of the Bundled Payments for Care Improvement models, which link 
payments for multiple services beneficiaries receive during an episode 
of care. The Mississippi Primary Health Care Association received 
funding through the Strong Start for Mothers and Newborns Initiative, 
which aims to reduce preterm births and improve outcomes for newborns 
and pregnant women. It is partnering with eight local organizations to 
test the Maternity Care Home Approach, which includes enhanced prenatal 
care including psychosocial support, education and health promotion in 
addition to traditional prenatal care. Services provided will expand 
access to care, improve care coordination and provide a broader array 
of health services. Additionally, Health Care Innovation awardees are 
conducting work in Mississippi, with projects that include care 
navigation for Medicare beneficiaries with complex or advanced stage 
cancer. For more information on Innovation Center activities in 
Mississippi please visit: http://innovation.cms.gov/initiatives/map/
index.html#state=MS.
    In addition, there are opportunities for Mississippi to apply for 
fiscal year 2015 telehealth funding through the Office for the 
Advancement of Telehealth within the Health Resources and Services 
Administration. HRSA will soon release a Funding Opportunity 
Announcement for a telehealth program that focuses on children living 
in high poverty rural areas. The purpose of the Rural Child Poverty 
Telehealth Network Grant Program is to demonstrate how telehealth 
networks can expand access to, coordinate and improve the quality of 
healthcare services for children living in impoverished rural areas and 
in particular how such networks can be enhanced through the integration 
of social and human service organizations. HRSA will award up to three 
pilot grants for a total annual investment of $975,000 in fiscal year 
2015 and $2.9 million over 3 years. Applications from States with high 
levels of rural child poverty will be very competitive for this 
program. The Office for the Advancement of Telehealth can work with 
applicants from Mississippi and other States that may have an interest 
in this funding opportunity. Furthermore, the Federal Office of Rural 
Health Policy supports Telehealth Resource Centers, which are centers 
of telehealth excellence that provide technical assistance to rural 
communities, healthcare organizations, healthcare networks, and 
healthcare providers in the implementation of cost effective telehealth 
programs to serve rural and medically underserved areas and 
populations. The South Central Telehealth Resource Center serves 
communities in Mississippi, Arkansas, and Tennessee.
    Further, the Office of the National Coordinator for Health 
Information Technology (ONC) recently announced a Community 
Interoperability and Health Information Exchange Cooperative Agreement 
Program for $1,000,000. Earlier this year ONC announced funding 
opportunities to support healthcare across the continuum including 
grants to advance interoperability health information technology 
services to support health information exchange; workforce training to 
educate healthcare professionals in health information technology; and, 
funding to support community health peer learning programs.
                    combating antibiotic resistance
    Question. Secretary Burwell, antibiotic-resistant bacteria poses a 
serious public health risk and economic threat to our country. The 
Centers for Disease Control and Prevention estimates that 23,000 people 
die each year in the United States as a direct result of antibiotic-
resistant infection and that antibiotic resistance costs taxpayers $20 
billion or more per year in additional healthcare costs. There is also 
growing concern regarding the possible transmission of antibiotic 
resistance between animals and humans. Can you speak to the importance 
of investing in research to combat antibiotic-resistant bacteria, in 
particular being certain to focus on funding proposals that include 
both animal and human populations in their research?
    Answer. Antibiotics are recognized as one of the greatest advances 
in the history of medicine, representing extraordinary progress in 
safeguarding human and animal health. The rising tide of resistance has 
made medical practitioners and society more aware of the urgent need to 
reduce the use of antibiotics as much as possible. At the same time, 
there is need for investing more into new therapeutic approaches, and 
investigating alternative animal husbandry and patient management 
practices that will reduce our reliance on antibiotics.
    The White House's National Strategy for Combating Antibiotic 
Resistant Bacteria lists five goals, one of which is to accelerate 
research into new antibiotics and other therapeutics, including 
vaccines. In addition, the National Strategy emphasizes the importance 
of surveillance to track the changing face of resistance and to measure 
any interventions designed to reduce the prevalence of resistant 
pathogens. The fiscal year 2016 Budget strongly promotes the field of 
antibiotics research. The Budget proposes an almost $1 billion 
investment in fiscal year 2016--nearly double the 2015 funding level--
across HHS.
    Multiple environmental factors, in addition to antibiotic use in 
humans and food animals, likely play a role in antibiotic resistance. 
Research to identify those various factors and the additive or 
synergistic effects they may have must be conducted to fully understand 
how antimicrobial resistance changes over time.
    In the agriculture sector, research is critical to identifying 
novel technologies that can be used instead of antibiotics to keep 
animals healthy. This research includes feed and nutritional 
supplements, as well as immune modulators, that can strengthen the 
immune system; therapy using bacteriophage (viruses that infect and 
kill bacteria) or their gene products; prebiotics and probiotics to 
promote gut health; therapeutic antibodies and new vaccines. Research 
in this area can reduce the need for antibiotics in agricultural animal 
production. This effort does not obviate the need for continuous work 
to develop new antibiotics, especially those with activity against 
multi-resistant pathogens. Because there is a need for both new 
antimicrobial therapies and to promote less reliance on them at the 
same time, FDA needs to assess challenges associated with their 
commercialization and use, and provide clear processes to support their 
development.
    FDA is actively working to help accelerate development of 
antibacterial drugs. Currently, FDA is implementing the new provisions 
of the Generating Antibiotic Incentives Now Act passed as part of 
FDASIA, which was enacted to encourage the development of antibacterial 
and antifungal drugs to treat serious or life-threatening infections. 
As part of these efforts, the Generating Antibiotic Incentives Now Act 
provides for an additional 5 years of exclusivity, as well as priority 
review and fast-track status, for certain products that are designated 
as Qualified Infectious Disease Products. FDA has granted 71 Qualified 
Infectious Disease Product designations for 47 unique chemical entities 
(as of March 26, 2015). These efforts are already having an impact. 
Within the past year, five new antibacterial drugs with Qualified 
Infectious Disease Product designation have been approved. In contrast, 
only five new antibiotics had been approved in the previous 10 year 
period.
    FDA is also working on a number of different activities to 
facilitate the development of antibacterial drugs so that healthcare 
providers have new antibacterial drug therapies to treat their 
patients, including:
  --FDA is engaged with public-private partnerships on this topic and 
        has participated in meetings that address a number of important 
        topics associated with the development of new antibacterial 
        drugs. FDA also has held numerous workshops attended by, and 
        sometimes co-sponsored with, external stakeholders, which have 
        served as a venue to discuss the many challenging issues 
        related to antibiotic clinical trial design and development.
  --FDA is actively meeting with drug companies that are developing 
        antibacterial drugs to provide advice on antibacterial drug 
        development programs.
  --FDA is publishing and updating draft and final guidance documents 
        on recommended clinical trial designs to facilitate development 
        of antibacterial drugs.
                                 ______
                                 
             Question Submitted by Senator Lamar Alexander
                duplication of early childhood services
    Question. The Government Accountability Office and others have 
raised concerns that Federal funding directed towards early childhood 
programs has resulted in fragmentation and duplication of services. 
Recognizing the critical role that early childhood services play in 
helping kids enter the classroom prepared to learn, can you address how 
this overlap and duplication affects the delivery of these services? 
Can you speak to what the Department is doing to minimize duplication, 
and how the Department can more efficiently use Federal funds to 
prevent fragmentation?
    Answer. The fiscal year 2016 Budget proposes a series of 
investments across HHS and the Department of Education that will 
support a continuum of high-quality early learning for children, 
beginning at birth and continuing to age five. Thanks to bipartisan 
Congressional support, we have made substantial investments in early 
learning programs, including $500 million in Early Head Start-Child 
Care Partnerships. Each of these programs serves a different and 
complementary role and is structured to collaborate with other early 
care and education programs in their communities.
    There are three main ways that low-income children access quality 
early learning programs: Head Start, child care programs, and public 
pre-K. Many communities use funding from each of these programs to meet 
the needs of children in these areas, such as leveraging child care to 
ensure children in Head Start or public pre-K have access to a full 
workday of care. HHS works with our partners at the Department of 
Education to increase interagency collaboration, including through 
Preschool Development Grants, to achieve the common goal of increasing 
access to high-quality care.
    This collaboration also includes developing a full report to 
congress on early childhood coordination and duplication, as required 
by the Child Care and Development Block Grant Act of 2014.
    Furthermore, HHS is also implementing several programs and 
initiatives at the Federal, State and local level aimed at alignment 
and reducing duplication, including:
  --Early Head Start-Child Care Partnerships (EHS-CCPs).--Early Head 
        Start-Child Care Partnership grants promote greater 
        coordination between Early Head Start and child care, by 
        providing funding to Early Head Start providers to partner with 
        local child care programs. These Partnerships provide more of 
        our Nation's youngest children and their families with access 
        to high quality early learning experiences that will set them 
        up for success in school and beyond. The President's Budget 
        includes an additional $150 million to expand Early Head Start-
        Child Care Partnerships, which would expand access to high-
        quality early learning experiences for more infants, toddlers, 
        and their families, while simultaneously enabling greater 
        alignment across the two programs.
  --Technical Assistance.--We are transforming our technical assistance 
        system to maximize the impact of technical assistance funding 
        in Head Start and child care by aligning efforts across both 
        programs, eliminating any duplication, and ensuring that both 
        programs receive the high-quality technical assistance they 
        need to deliver the best services to children and families.
  --The State Advisory Councils for Early Care and Education (SAC).--
        HHS continues to encourage collaboration and coordination with 
        State Advisory Councils to develop high-quality, comprehensive 
        systems of early childhood development and care and increase 
        alignment between the various sectors within each State that 
        provide services to young children.
  --Intra- and Interagency Partnerships.--We have brought together 
        several operating divisions within HHS, including the 
        Administration for Children and Families, National Institutes 
        of Health, Centers for Disease Control and Prevention, Health 
        Resources Services Administration, Substance Abuse and Mental 
        Health Services Administration, and others to better coordinate 
        and align our early learning services. In addition, we have 
        worked with several other Federal agencies over the last 
        several months, including Departments of Defense, Agriculture, 
        Housing and Urban Development, and Education, on other 
        initiatives that help align our messages and services, and 
        share lessons learned across programs.
    The Department is making important strides in aligning, 
coordinating, and streamlining early childhood programs and services. 
However, too many children do not have access to high quality early 
learning programs that can help them thrive in school and beyond. For 
example, Early Head Start one of the largest Federal early childhood 
program for infants and toddlers, only serves about 5 percent of all 
eligible children. We will continue to work with our partners to 
minimize duplication and ensure strong alignment so that as many 
children as possible receive high quality early learning services that 
set them up to achieve their full potential, improving our Nation's 
competitive edge in a global economy.
                                 ______
                                 
              Questions Submitted by Senator Bill Cassidy
                         unaccompanied children
    Question. In 2013, DHS, HHS, and other Federal agencies anticipated 
a sharp increase in unaccompanied minors crossing into the United 
States from Mexico. Accordingly, HHS was given $1.8 billion to provide 
the appropriate care for unaccompanied children.
    In July, 2014, the Subcommittee on Oversight and Investigations in 
the Energy and Commerce Committee held a briefing in response to the 
border crossings being overwhelmed by unaccompanied children and 
inadequate medical services to help them. During that hearing, Dr. Curi 
Kim, Director of the Division of Refugee Health in the Office of 
Refugee Resettlement ORR) at HHS told the subcommittee that she had 
been transferred two weeks earlier from the Public Health Service. 
Prior to her transfer, the entire response had been handled by 2 
nurses. The hiring of Dr. Kim was part of a ramping up to address the 
crisis. Please answer the following questions
    What is the current volume of services provided by ORR to address 
the border crisis?
    Answer. Unaccompanied children are referred to ORR by another 
Federal agency, usually the Department of Homeland Security. ORR's 
statutory obligation is to place the child in the least restrictive 
setting that is in the best interest of the child, taking into account 
the child's potential danger to self or others, and risk of flight. 
Funding provided for unaccompanied children has increased as the number 
of children has risen. ORR received $948 million for unaccompanied 
children in fiscal year 2015 compared to $376 million in fiscal year 
2013.
    ORR's care and placement of unaccompanied children is governed by 
established child welfare protocols and other Federal statutes and 
obligations. ORR provides care for the majority of unaccompanied 
children referred to it through a network of State-licensed, ORR-funded 
care providers, most of which are located close to the areas where 
immigration officials apprehend the majority of children. ORR provides 
various types of care for the children, depending on the particular 
circumstances of the child involved, ranging from foster care, group 
homes, and shelters, to secure facilities, and residential treatment 
centers. ORR's providers operate under cooperative agreements and 
contracts, and provide children with classroom education, healthcare, 
socialization/recreation, vocational training, mental health services, 
help with access to legal services, case management, and facilitate the 
safe and timely release to a sponsor where appropriate.
    As you note in your question, there was a significant increase in 
the number of unaccompanied children apprehended on the southwest 
border last year. The Administration responded with an aggressive, 
coordinated Federal response focused on providing humanitarian care for 
the children as well as on stronger deterrence, enforcement, foreign 
cooperation, and capacity for Federal agencies to ensure that our 
border remains secure. In part due to Administration efforts, including 
increased border security and assistance to Central American 
governments to curb the flow of unaccompanied children, the current 
rate of referrals to ORR is well below fiscal year 2014 levels. In 
light of these efforts and the recent fall in the number of children 
placed in ACF's custody, DHS, HHS, and the other agencies responsible 
for monitoring and serving unaccompanied children expect arrivals to 
remain stable, though we remain vigilant and are making the appropriate 
preparations should we experience seasonal increases in migration in 
the coming months.
    ORR is continually evaluating its work on the Unaccompanied 
Children Program and is committed to implementing appropriate policy 
and operational improvements, including those that would enable the 
agency to serve higher than expected caseloads should arrivals 
unexpectedly increase. For example, since the increase in referrals 
during the summer of 2014, ORR has bolstered staff capacity in the 
Unaccompanied Children Program, through the addition of medical staff 
personnel and the implementation of an Unaccompanied Children 
Monitoring Team. To ensure unity of effort across the Executive Branch 
in response to the influx of unaccompanied children across the 
southwest border last year, the President directed the creation of the 
Unified Coordination Group, whose members include the Departments of 
Health and Human Services, Homeland Security, and Defense. Members meet 
regularly to monitor arrival levels and develop plans to ensure 
sufficient capacity is available if the number of children increases. 
ORR has also significantly increased the number of permanent shelter 
beds as well as the agency's ability to rapidly bring temporary 
capacity online, if such capacity is needed.
    Question. Are all of these services provided at the border or are 
services continually provided after transfer?
    Answer. Unaccompanied children are referred to ORR by other Federal 
agencies, usually the Department of Homeland Security. ORR does not 
generally provide services to unaccompanied children at the border. 
Instead, DHS provides initial services to the unaccompanied children it 
detains and ORR provides services after the children are transferred to 
its custody. Care is provided in a network of shelters located in 15 
States across the country, where shelter and services are provided 
until a child is released to the custody of an appropriate sponsor, 
usually a parent or family member, while their immigration case is 
adjudicated.
    Question. How many unaccompanied children are currently being 
served by ORR or will be served this year?
    Answer. In the first 6 months of fiscal year 2015, a total of 
11,706 children were referred to ORR. In part due to Administration 
efforts, including increased border security and assistance to Central 
American governments to curb the flow of unaccompanied children, the 
current rate of referrals to ORR is well below fiscal year 2014. In 
light of these efforts and the recent fall in the number of children 
placed in ACF's custody, DHS, HHS, and the other agencies responsible 
for monitoring and serving unaccompanied children expect arrivals to 
remain stable, though we remain vigilant and are making the appropriate 
preparations should we experience seasonal increases in migration in 
the coming months.
                   medicaid expenditures per enrollee
    Question. Every year, the nonpartisan Congressional Budget Office 
projects the Federal cost of adult enrollees in Medicaid. The CBO 
projects this cost to increase by about 6 percent every year. However, 
from 2014 to 2015 and after Medicaid expansion, the growth in Medicaid 
costs for adults is projected to be 36.5 percent.
    Now, I understand that the Federal Government pays more to Medicaid 
Expansion recipients- in fact, 70 percent more to each adult 
beneficiary. However, the Expansion population only comprises one in 
five of all Medicaid adult enrollees. Furthermore, these individuals 
are in better economic situations than the original Medicaid 
population, which suggests to me they should, on average, be healthier. 
The numbers simply don't add up here.
    Madam Secretary, my question to you is this: We know with every 
passing year, the Federal Government spends more and more money on each 
Medicaid enrollee. However, why are Federal costs per Medicaid enrollee 
going up even more rapidly than anticipated?
    Please give a State by State breakdown of average per person 
Medicaid payments by the Federal Government for the adult non-long-term 
care, non-disabled population. Please breakout payment on behalf of the 
dual eligible population separately.
    Answer. We understand that there have been important changes to the 
way in which CBO reports average Federal spending on benefit payments 
per adult Medicaid enrollee between the February 2013 baseline and the 
March 2015 baseline. As a result, it is not accurate to say that there 
has been a 36.5 percent jump in per person Medicaid costs because the 
increase largely reflects changes in methodology rather than an 
increase in per person costs.
    My understanding is that the March 2015 estimate of Federal 
spending per adult Medicaid enrollee in fiscal year 2014 reflects only 
those who were enrolled on an average monthly basis. The February 2013 
baseline, on the other hand, reflects those who were enrolled at any 
time during the fiscal year. The number of enrollees who ever enroll in 
Medicaid over the course of the year is much higher than the average 
number who are enrolled each month. As a result, shifting to average 
monthly enrollment made average spending higher, holding other factors 
constant. We understand this change was the overwhelming driver of the 
apparent increase in per adult Medicaid spending from the February 2013 
baseline.
    There were also two other notable changes between the February 2013 
baseline and the March 2015 baseline, the effects of which largely 
cancel each other out. First, the March 2015 baseline includes the 
average cost of all enrollees who receive any Medicaid benefit, 
including partial benefits such as family planning services or premium 
assistance. In prior years, including the February 2013 baseline, 
average per enrollee spending was reported only for those who received 
full Medicaid benefits. Including partial benefit enrollees reduced 
average spending per enrollee, holding other factors constant. Second, 
Medicaid enrollment in the newly eligible adult group during fiscal 
year 2014 was much higher than CBO assumed in the February 2013 
baseline. Because the coverage of newly eligible individuals was 
matched at 100 percent of cost, the average Federal spending on all 
adults was higher than predicted. In terms of magnitude, the revision 
for actual enrollment largely offset the revision from including 
partial benefit enrollees when calculating average spending.

                MEDICAID EXPENDITURES PER ENROLLEE NON-DUAL NON-DISABLED ADULTS FISCAL YEAR 2011
----------------------------------------------------------------------------------------------------------------
                                                                                                        Federal
                                           Total        FMAP       Federal                  Total Per     Per
                State                  Expenditures     (%)     Expenditures    Enrollment   Enrollee   Enrollee
                                            ($)                      ($)                    Costs ($)  Costs ($)
----------------------------------------------------------------------------------------------------------------
AK..................................     208,467,861     68.1     141,891,657       22,237      9,375      6,381
AL..................................     369,755,926     74.7     276,160,670      141,463      2,614      1,952
AR..................................     182,278,647     77.3     140,900,145       84,898      2,147      1,660
AZ..................................   2,239,948,224     72.9   1,632,641,631      374,094      5,988      4,364
CA..................................   4,910,000,444     58.7   2,880,486,830    3,532,286      1,390        815
CO..................................     404,999,401     57.1     231,184,337      111,569      3,630      2,072
CT..................................   1,243,432,041     55.3     687,023,317      214,014      5,810      3,210
DC..................................     400,017,066     73.8     295,073,939       74,798      5,348      3,945
DE..................................     504,625,221     60.0     302,746,622       79,207      6,371      3,822
FL..................................   2,000,368,789     67.6   1,353,071,663      415,745      4,812      3,255
GA..................................   1,329,982,770     71.3     947,963,026      180,783      7,357      5,244
HI..................................     379,470,271     62.0     235,105,589       86,911      4,366      2,705
IA..................................     349,405,237     68.3     238,658,258      132,980      2,628      1,795
ID..................................     190,483,057     75.0     142,856,372       23,026      8,273      6,204
IL..................................   1,702,698,573     57.3     976,349,185      665,019      2,560      1,468
IN..................................     735,222,485     72.1     530,127,190      175,435      4,191      3,022
KS..................................     197,140,360     65.1     128,354,176       37,481      5,260      3,425
KY..................................     676,158,203     77.1     520,994,571       93,716      7,215      5,559
LA..................................     542,102,669     76.3     413,752,570      186,248      2,911      2,222
MA..................................   2,038,976,156     56.9   1,159,527,176      395,633      5,154      2,931
MD..................................   1,290,264,429     57.2     737,560,005      241,132      5,351      3,059
ME..................................     152,375,396     75.0     114,263,492       89,027      1,712      1,283
MI..................................   1,832,846,010     71.5   1,311,198,862      461,118      3,975      2,844
MN..................................   1,323,046,503     56.0     740,515,029      247,604      5,343      2,991
MO..................................     578,490,728     69.9     404,342,525      177,091      3,267      2,283
MS..................................     379,053,250     81.0     307,175,593       82,379      4,601      3,729
MT..................................      80,947,949     79.9      64,660,586       13,084      6,187      4,942
NC..................................   1,247,215,744     70.9     883,952,339      263,326      4,736      3,357
ND..................................      66,984,523     67.7      45,377,384       11,222      5,969      4,044
NE..................................     181,642,330     64.5     117,140,422       30,121      6,030      3,889
NH..................................      68,470,986     58.1      39,780,140       14,700      4,658      2,706
NJ..................................     596,224,059     56.5     336,967,325      124,488      4,789      2,707
NM..................................     625,080,778     76.9     480,834,413      103,384      6,046      4,651
NV..................................     168,544,911     59.2      99,783,166       45,429      3,710      2,196
NY..................................   9,845,134,760     57.5   5,657,875,667    1,826,757      5,389      3,097
OH..................................   2,508,881,299     69.5   1,743,556,007      463,997      5,407      3,758
OK..................................     480,052,216     73.2     351,169,665      134,281      3,575      2,615
OR..................................     969,417,749     69.0     669,253,158      157,102      6,171      4,260
PA..................................   1,736,112,903     62.8   1,089,788,414      396,911      4,374      2,746
RI..................................     162,760,730     59.7      97,130,350       34,350      4,738      2,828
SC..................................     747,374,985     75.7     566,038,147      166,576      4,487      3,398
SD..................................      85,435,845     72.7      62,122,183       14,632      5,839      4,246
TN..................................   2,196,265,388     71.6   1,572,824,967      239,511      9,170      6,567
TX..................................   1,668,973,573     66.6   1,110,774,811      373,828      4,465      2,971
UT..................................     246,176,054     76.7     188,887,883       57,921      4,250      3,261
VA..................................     693,902,213     57.6     399,750,984      118,683      5,847      3,368
VT..................................     254,738,538     65.1     165,791,610       63,931      3,985      2,593
WA..................................     870,748,402     58.2     506,695,203      200,079      4,352      2,532
WI..................................   1,061,801,563     66.7     708,312,475      357,494      2,970      1,981
WV..................................     245,858,758     78.8     193,695,052       40,107      6,130      4,829
WY..................................      62,525,900     59.1      36,936,374        8,381      7,460      4,407
----------------------------------------------------------------------------------------------------------------
Source: Medicaid Statistical Information System, Annual Person Summary.
Notes:
1. Expenditures and enrollment are calculated using the Medicaid Statistical Information System (MSIS) Annual
  Person Summary (APS) for 2011, which was the last year that data for most States is available in the APS. 2011
  data is incomplete or missing for Florida, Maine, and Montana. 2010 data is provided for these States.
2. MSIS does not contain all Medicaid expenditures, including supplemental payments to providers, prescription
  drug rebates, and Medicare premiums. These costs may have significant impacts on the total costs and per
  enrollee costs for these enrollees.
3. The FMAPs in 2010 and 2011 were affected by the temporary FMAP increases provided under the American Recovery
  and Reinvestment Act of 2009 and the 6-month extension through June 2011. The FMAPs shown reflect the
  estimated weighted average FMAP for adults' costs in 2010 and 2011.
4. Enrollment is in person-year equivalents (or average annual enrollment).
5. Expenditures and enrollment for adults include persons with basis of eligibility as adult, unemployed adult,
  and Breast and Cervical Cancer Act adults. Expenditures and enrollment based on the last value for basis of
  eligibility and dual status in MSIS.

              MEDICAID EXPENDITURES PER ENROLLEE DUAL ELIGIBLE NON-DISABLED ADULTS FISCAL YEAR 2011
----------------------------------------------------------------------------------------------------------------
                                                                                                        Federal
                                           Total        FMAP       Federal                  Total Per     Per
                State                  Expenditures     (%)     Expenditures    Enrollment   Enrollee   Enrollee
                                            ($)                      ($)                    Costs ($)  Costs ($)
----------------------------------------------------------------------------------------------------------------
AK..................................         639,805     68.1         435,477           72      8,886      6,048
AL..................................       1,971,671     74.7       1,472,588          293      6,729      5,026
AR..................................         861,417     77.3         665,869          157      5,487      4,241
AZ..................................      40,716,659     72.9      29,677,343        7,136      5,706      4,159
CA..................................      83,783,764     58.7      49,152,344       19,699      4,253      2,495
CO..................................       1,328,876     57.1         758,557          504      2,637      1,505
CT..................................      27,323,646     55.3      15,096,910        4,942      5,529      3,055
DC..................................       2,442,869     73.8       1,801,991          406      6,017      4,438
DE..................................       1,528,075     60.0         916,759          544      2,809      1,685
FL..................................       7,685,022     67.6       5,198,234        1,729      4,445      3,006
GA..................................       6,640,173     71.3       4,732,872          673      9,867      7,032
HI..................................       1,678,894     62.0       1,040,180          283      5,932      3,676
IA..................................       1,801,987     68.3       1,230,832          581      3,102      2,118
ID..................................       6,276,849     75.0       4,707,442          319     19,677     14,757
IL..................................      46,862,270     57.3      26,871,426       15,127      3,098      1,776
IN..................................       5,767,466     72.1       4,158,592          388     14,865     10,718
KS..................................         705,476     65.1         459,321          176      4,008      2,610
KY..................................       3,680,938     77.1       2,836,243          334     11,021      8,492
LA..................................       3,159,337     76.3       2,411,321          383      8,249      6,296
MA..................................       5,336,800     56.9       3,034,937          670      7,965      4,530
MD..................................      20,083,848     57.2      11,480,626        4,072      4,932      2,819
ME..................................       8,892,064     75.0       6,667,994        4,432      2,006      1,505
MI..................................     136,291,184     71.5      97,501,287        4,542     30,007     21,467
MN..................................      17,875,801     56.0      10,005,166        2,497      7,159      4,007
MO..................................       2,004,571     69.9       1,401,117          453      4,425      3,093
MS..................................       1,083,599     81.0         878,122          169      6,412      5,196
MT..................................       6,931,582     79.9       5,536,893        1,229      5,640      4,505
NC..................................       6,390,175     70.9       4,528,976          802      7,968      5,647
ND..................................         494,823     67.7         335,208           44     11,246      7,618
NE..................................         922,891     64.5         595,169           88     10,487      6,763
NH..................................       3,712,109     58.1       2,156,654          800      4,640      2,696
NJ..................................      17,762,091     56.5      10,038,582        1,266     14,030      7,929
NM..................................         528,439     76.9         406,494          172      3,072      2,363
NV..................................         831,754     59.2         492,421          195      4,265      2,525
NY..................................      96,163,929     57.5      55,264,206       12,901      7,454      4,284
OH..................................      41,234,788     69.5      28,656,263        4,394      9,384      6,522
OK..................................       3,647,313     73.2       2,668,097          371      9,831      7,192
OR..................................         370,102     69.0         255,506           33     11,215      7,743
PA..................................      11,835,648     62.8       7,429,443        1,524      7,766      4,875
RI..................................       2,647,990     59.7       1,580,235        1,327      1,995      1,191
SC..................................      21,607,989     75.7      16,365,207        1,961     11,019      8,345
SD..................................         399,687     72.7         290,621           66      6,056      4,403
TN..................................      31,713,357     71.6      22,711,080        4,166      7,612      5,452
TX..................................       7,110,421     66.6       4,732,296        1,018      6,985      4,649
UT..................................         682,330     76.7         523,543           92      7,417      5,691
VA..................................       2,830,893     57.6       1,630,853          414      6,838      3,939
VT..................................         694,045     65.1         451,706          143      4,853      3,159
WA..................................       3,445,979     58.2       2,005,242          649      5,310      3,090
WI..................................      24,578,667     66.7      16,396,073        5,939      4,139      2,761
WV..................................       1,771,716     78.8       1,395,812          272      6,514      5,132
WY..................................         195,825     59.1         115,681           29      6,753      3,989
----------------------------------------------------------------------------------------------------------------
Source: Medicaid Statistical Information System, Annual Person Summary.
Notes:
1. Expenditures and enrollment are calculated using the Medicaid Statistical Information System (MSIS) Annual
  Person Summary (APS) for 2011, which was the last year that data for most States is available in the APS. 2011
  data is incomplete or missing for Florida, Maine, and Montana. 2010 data is provided for these States.
2. MSIS does not contain all Medicaid expenditures, including supplemental payments to providers, prescription
  drug rebates, and Medicare premiums. These costs may have significant impacts on the total costs and per
  enrollee costs for these enrollees.
3. The FMAPs in 2010 and 2011 were affected by the temporary FMAP increases provided under the American Recovery
  and Reinvestment Act of 2009 and the 6-month extension through June 2011. The FMAPs shown reflect the
  estimated weighted average FMAP for adults' costs in 2010 and 2011.
4. Enrollment is in person-year equivalents (or average annual enrollment).
5. Expenditures and enrollment for adults include persons with basis of eligibility as adult, unemployed adult,
  and Breast and Cervical Cancer Act adults. Expenditures and enrollment based on the last value for basis of
  eligibility and dual status in MSIS.

                                 ______
                                 
          Questions Submitted by Senator Shelley Moore Capito
                       black lung clinics program
    Question. Last year, HHS allowed the State of West Virginia and the 
private West Virginia Primary Care Association to submit duplicative 
grant applications to essentially evade the newly imposed caps for the 
Black Lung Clinics program. During the hearing, the Secretary stated 
the cap was imposed as a result of a review regarding the quality of 
grant making and the need to get the funds closer to the local 
communities. By having to split these funds between the two, tens of 
thousands of dollars of administrative costs were incurred, and thus 
wasted. If the goal is to improve the quality of the grant, how can 
this duplication be a better way of managing the process?
    Answer. As you know, the incidence rate of black lung disease has 
increased across the country. To be responsive to this increase and 
emerging data from the National Institute for Occupational Safety and 
Health, HRSA modified the funding structure of the Black Lung Clinic 
program in fiscal year 2014. This structure took into account the $6.7 
million appropriation for the program in fiscal year 2014 and set a 
funding amount that each applicant could apply for in order to ensure 
that applications from a broad range of areas had the potential to 
receive support with the available resources. Collaboration was 
encouraged to better target resources and to best meet existing needs 
within States and communities. The addition of the primary care 
association as a grantee in West Virginia has helped broaden the reach 
of primary care providers across the State, providing opportunities to 
better serve the target population. In previous years, Kentucky, 
Illinois and Pennsylvania have all had more than one grantee in their 
State. In several States, HRSA has witnessed effective partnerships of 
State and community-based grantees working together to serve those with 
Black Lung disease. We look forward to continuing to work with you and 
grantees in West Virginia to promote similar collaboration and ensure 
that needs of this population are being met.
    Question. Wouldn't it make more sense to evaluate grantee 
applications based on the need for services and the grantees' ability 
to deliver those services, rather than imposing an arbitrary cap that 
has led to increased administration costs?
    Answer. The application review criteria did require applicants to 
demonstrate the need for the services and the ability to deliver the 
services. This took into account the number of miners in each State, 
along with the quality and breadth of services the applicant intended 
to provide.
    Question. During the budget hearing discussion on the Black Lung 
Program, the Secretary stated that there was difficulty in measurement 
and that ``We may need some help.'' What actions does HHS feel Congress 
should take in this regard to make the necessary improvements?
    Answer. There are several data challenges in serving this 
population. There are data on current or active coal miners, but 
finding data on the location of retired miners can be more challenging. 
There are also data on severity of black lung disease, but most of the 
data are at the national and State level with less available data at 
the sub-State level. HRSA's funding for the Black Lung Clinic program 
supports direct services and public health infrastructure rather than 
for broad data collection. However, HRSA is working with the National 
Institute of Occupational Safety and Health, located within CDC, and 
the Mine Safety and Health Administration, located within the 
Department of Labor, to identify ways to collect more accurate data on 
miners. We will also work with the current Black Lung Clinic grantees 
to collect data on miners to better inform the program moving forward.
    medicare part d: preferred cost sharing networks for pharmacies
    Question. Last year, as part of a much broader rulemaking, CMS 
released a proposed regulation that sought to address the issue of 
access to local pharmacies for rural seniors on Part D drug plans. That 
larger rule was ultimately withdrawn. Since that time, CMS released a 
study in December 2014 showing that at least some Part D plans are 
failing to meet pharmacy access requirements. With the proliferation of 
preferred pharmacy networks in Medicare Part D, what actions do you 
believe are necessary to preserve seniors' access to their local 
pharmacies?
    Answer. I understand your concern about access to independent 
pharmacies, and share your concerns about the transparency of preferred 
cost sharing networks for pharmacies. CMS is vigorously enforcing the 
statutory requirement that all pharmacies be offered a contract to 
participate in a Part D plan's standard network.
    Additionally, to help address concerns about beneficiary access to 
preferred cost sharing pharmacies, the 2016 Medicare Advantage & Part D 
Final Call Letter announced several steps to help beneficiaries 
understand whether a plan offers preferred cost sharing at their local 
pharmacy prior to selecting that plan.
                                 ______
                                 
             Questions Submitted by Senator James Lankford
                          transition to icd-10
    Question. The transition to ICD-10 is scheduled to take place on 
October 1, 2015. The American Medical Association recently wrote a 
letter to the Acting Director of CMS outlining several concerns and 
states, in part, that ``By CMS's own analysis, one of the most 
significant risks to moving to ICD-10 is the likelihood for claims 
processing and cash flow interruptions.'' The American Health 
Information Management Association, in its ``frequently asked 
questions'' document recommends that CMS ``grant `advance payments' to 
any physicians that do experience cash flow disruptions as a result of 
the ICD-10 transition.'' I understand that CMS has indicated that will 
use advance payments, but it has not yet made public this policy. Does 
CMS, in fact, plan to make advance payments? If not, why not? And, if 
so, please explain the policy and what steps CMS will take to educate 
providers to ensure they are aware of this policy.
    Answer. CMS is ready for ICD-10. And, thanks to many partners--
spanning providers, health plans, coders, clearinghouses, professional 
associations and vendor groups--the healthcare community at large will 
be ready for ICD-10 on October 1. I appreciate the tremendous efforts 
and achievements of health professionals as we work together to realize 
the benefits of ICD-10 and other advances toward the ultimate goal of 
improving the quality and affordability of healthcare for all 
Americans.
    If providers are unable to code using ICD-10, tailored training, 
resources, and tools are available specifically to help physicians and 
their staffs prepare for the ICD-10 transition. There is still time for 
providers to prepare. CMS has developed multiple tools and resources 
that are available on the ICD-10 website (http://www.cms.gov/ICD10), 
including ICD-10 implementation guides, tools for small and rural 
providers, and general equivalency mappings (ICD-9 to ICD-10 
crosswalk).
    CMS has the following options for providers who are unable to 
submit claims with ICD-10 diagnosis codes due to problems with the 
provider's system. Each of these options requires that the physician be 
able to code in ICD-10:
  --Free billing software that can be downloaded at any time from every 
        MAC;
  --Claims submission functionality on the MAC's provider Internet 
        portal; and
  --Submitting paper claims, if the requirements of section 1862(h) are 
        met.
    I understand that CMS is able to issue advance payments to 
physicians/suppliers furnishing Part B services only when CMS systems 
are unable to process valid Part B claims that contain ICD-10 codes 
beginning October 1, 2015. CMS has no authority to make advance 
payments if providers are unable to submit a valid claim using ICD-10 
codes. Therefore, our focus has been on ensuring that providers receive 
the education and tools they need to successfully submit claims. CMS 
has been conducting extensive testing to ensure Medicare claims 
processing systems are ready for ICD-10.
    Question. There are outstanding questions in the physician 
community concerning the specificity of codes required for inclusion on 
Medicare claims following the transition to ICD-10. According to the 
American Medical Association, ``CMS officials have stated that, absent 
indications of potential fraud or intent to purposefully bill 
incorrectly, CMS will not instruct its contractors to audit claims to 
verify that the most appropriate ICD-10 code was used.'' Has CMS 
conducted any stakeholder and contractor education to ensure that 
claims are not audited simply for code specificity? If yes, please 
provide those education materials to the Subcommittee. If no, will CMS 
conduct stakeholder and contractor education to prevent this kind of 
audit? If not, why not?
    Answer. CMS has issued guidance on the use of unspecified codes for 
Medicare Fee-for-Service claims. In both ICD-9 and ICD-10, signs/
symptoms and unspecified codes have acceptable, even necessary, uses. 
While specific diagnosis codes should be reported when they are 
supported by the available medical record documentation and clinical 
knowledge of the patient's health condition, in some instances signs/
symptoms or unspecified codes are the best choice to accurately reflect 
the healthcare encounter. Each healthcare encounter should be coded to 
the level of certainty known for that encounter. If a definitive 
diagnosis has not been established by the end of the encounter, it is 
appropriate to report codes for sign(s) and/or symptom(s) in lieu of a 
definitive diagnosis. When sufficient clinical information is not known 
or available about a particular health condition to assign a more 
specific code, it is acceptable to report the appropriate unspecified 
code (for example, a diagnosis of pneumonia has been determined but the 
specific type has not been determined). In fact, unspecified codes 
should be reported when such codes most accurately reflect what is 
known.
    All the Medicare claims audit programs will use the same approach 
under ICD-10 as is used under ICD-9. Physicians, like all providers, 
are expected to code correctly and have sufficient documentation to 
support the codes selected. For example, if a physician is treating a 
patient for diabetes, there should be an ICD-1 0 code on the claim for 
diabetes. The level of specificity of the diabetes code selected will 
not change the coverage and payment of services in most cases.
                recovery audit contractor program (racs)
    The purpose of an audit is to identify improper payments, not 
inaccurate coding. Will you direct CMS to issue guidance to its audit 
contractors to prohibit them from engaging in audits that are only 
predicated on code specificity? If not, why not? If yes, please provide 
a copy of that guidance to my office.
    Answer. CMS has announced a number of future changes to the 
Recovery Audit Program in response to industry feedback. In the process 
of procuring new contracts, these changes will result in a more 
effective and efficient program, including improved accuracy, less 
provider burden, and more program transparency. A comprehensive list of 
the Recovery Auditor program improvements can be found at: http://
www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/
Medicare-FFS-Compliance-Programs/Recovery-Audit-Program/Downloads/RAC-
Program-Improvements.pdf.
    Question. In July 2014, GAO found that CMS does not have sufficient 
information to determine whether its contractors conduct inappropriate 
duplicative claims reviews and that CMS has conducted insufficient data 
monitoring to prevent the RACs from conducting inappropriate 
duplicative reviews. GAO recommended that the Administrator of CMS take 
the following two actions:
  --Monitor the Recovery Audit Data Warehouse to ensure that all 
        postpayment review contractors are submitting required data and 
        that the data the database contains are accurate and complete; 
        and
  --Develop complete guidance to define contractors' responsibilities 
        regarding duplicative claims reviews, including specifying 
        whether and when MACs and ZPICs can duplicate other 
        contractors' reviews.
    GAO reported that taking these actions would help ensure that 
Medicare contractors conduct efficient and effective postpayment claims 
reviews and avoid inappropriate duplication, which is burdensome and 
costly to providers. In commenting on the July 2014 report on which 
this analysis is based, HHS stated it would update its guidance for 
contractors and would explore ways for HHS and contractors to be 
alerted when data are not entered into the Recovery Audit Data 
Warehouse within a certain timeframe. Has HHS updated its guidance for 
contractors? If not, please explain why not, and provide the 
Subcommittee with a date when we can expect HHS to update its 
contractor guidance. If yes, please provide a copy of that guidance.
    Answer. CMS has been making upgrades to the RAC Data Warehouse to 
enhance its capabilities. As noted in the GAO report, the RAC Data 
Warehouse works correctly when data is submitted. CMS has been running 
reports and validating that the contractors are submitting information 
about reviews they have on a timely basis to the RAC Data Warehouse. 
CMS is also working to establish performance metrics and award fee 
plans for timely and accurate submission of data.
    In addition, CMS is currently developing a reporting system that 
will provide CMS and its medical review contractors a single source of 
information on Medicare review programs from a provider perspective 
(e.g. when a provider received education on an issue, which claims were 
reviewed by the Medicare Administrative Contractor (MAC), Recovery 
Auditors, or Supplemental Medical Review Contractors). CMS plans to use 
the Provider Compliance Reporting System (PCRS) to ensure that the same 
provider/issue is not being reviewed by different medical review 
contractors at the same time.
    CMS will provide guidance on April 27, 2015; via contractor 
Technical Direction Letter (TDL) designating Recovery Auditors to delay 
sending Additional Documentation Requests until 60 days after the claim 
paid date. This delay is necessary to minimize the likelihood of 
Recovery Auditors reviewing a claim that had a prepayment review done 
by a MAC. MACs upload their complex reviews to the RAC Data Warehouse 
using a monthly system-generated file, which excludes the MAC-reviewed 
claims from potential re-review by a Recovery Auditor.
    Question. Please provide a list of all efforts undertaken by HHS to 
reform the RAC audit process--including draft, proposed, and final 
guidance or regulations.
    Answer. CMS has announced a number of future changes to the 
Recovery Audit Program in response to industry feedback. In the process 
of procuring new contracts, these changes will result in a more 
effective and efficient program, including improved accuracy, less 
provider burden, and more program transparency. A comprehensive list of 
the Recovery Auditor program improvements can be found at: http://
www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/
Medicare-FFS-Compliance-Programs/Recovery-Audit-Program/Downloads/RAC-
Program-Improvements.pdf.
                                 ______
                                 
              Questions Submitted by Senator Patty Murray
    implementation of the child care and development block grant act
    Question. Congress reauthorized the Child Care and Development 
Block Grant last year, and we included many new provisions designed to 
improve the safety and quality of care, such as greater enforcement of 
licensing standards. These new requirements will come with new costs 
for States. I understand that a large part of the President's request--
$266 million--would provide States with additional resources to meet 
these new requirements. How are you working with States to make sure 
that, as they implement the new quality and safety provisions, children 
and families don't lose access to child care? What would be the impact 
if CCDBG did not get additional resources in 2016?
    Answer. The Administration for Children and Families and the Office 
of Child Care are committed to supporting States by providing technical 
assistance and guidance on key issues, including on ways to promote 
access, as States implement the new Child Care and Development Block 
Grant reauthorization. State Lead Agencies are currently developing 
State plans for Federal fiscal years 2017-2019, which are due March 1, 
2016. HHS provided an extension of the deadline (which was originally 
July 1, 2015) at the request of State Administrators to allow time for 
thoughtful planning and partnership-building across the early childhood 
agencies in States. Currently, we have policy guidance and relevant 
resources available at www.acf.hhs.gov/programs/occ/ccdf-
reauthorization. In order to help States develop strategies around the 
specifics of new policies required by reauthorization, we have also 
compiled a set of technical assistance resources available at https://
childcareta.acf.hhs.gov/ccdf-reauthorization. Some of the technical 
assistance resources aim to help States implement the new quality and 
safety provisions in an efficient, cost-effective manner, with the goal 
of ensuring that sufficient resources remain to promote access to child 
care services. For example, HHS recently published a white paper on 
Innovation in Monitoring in Early Care and Education that outlines 
options for States, including approaches that provide greater 
coordination across early care and education sectors, and that can 
result in administrative efficiencies as well. Additionally, HHS is 
using both a set of meetings this spring and our large national meeting 
with State administrators in July to provide training and guidance 
around the provisions in the new law.
    Even with this technical assistance and guidance, we recognize that 
States need additional new funding to implement reauthorization, which 
is why the fiscal year 2016 Budget includes a $266 million increase in 
discretionary funding to help States implement the new law. However, 
even with these new discretionary resources, funding for child care 
assistance would fall well short of need, which is why the President's 
Budget also calls for significant additional mandatory funding for 
child care.
    Access to CCDF-funded child care assistance fell to an all-time low 
in fiscal year 2013 due to funding constraints, with an average of only 
1.4 million children served each month and only a small percentage of 
children eligible for assistance receive it. To address this serious 
gap, the President's Budget proposes to invest an additional $82 
billion in mandatory funding over the next 10 years to ensure that all 
low- and moderate-income working families with children under age four 
have access to high quality, affordable child care.
                cdc's tips from former smokers campaign
    Question. This subcommittee has provided significant investments 
for several years to the Office on Smoking and Health at CDC. This 
investment in tobacco control has led to reduced rates of smoking, 
exposure to second hand smoke, and increased smoking cessation. One 
recent study concluded that tobacco control efforts have prevented 8 
million premature deaths in the U.S. since 1964. A critical component 
of CDC's recent work is the ``Tips from Former Smokers'' campaign, 
combined with expanded Quitline support.
    What have been the results of the Tips campaign to date, and what 
are the plans for fiscal year 2016?
    Answer. In March 2012, CDC launched the first-ever paid national 
tobacco education campaign--Tips From Former Smokers (Tips). During the 
first 3 years of the Tips campaign, ads featured real people living 
with heart attacks, amputations, and other serious health conditions. 
Their stories sent a powerful message: Quit smoking now--or better yet, 
don't start. These hard-hitting ads delivered resulted in an estimated 
1.64 million people attempting to quit smoking. Approximately 100,000 
are expected to quit for good. Based upon the number of quit attempts, 
the 2012 Tips campaign prevented at least 17,000 premature deaths. Tips 
is a ``best buy'' in public health, at a cost of $393 per year of life 
saved. The accepted benchmark for cost effective health programs is 
below $50,000 per year of life saved.
    In March 2015, CDC launched a new round of Tips advertisements 
featuring macular degeneration and colorectal cancer--two diseases that 
the 2014 Surgeon General's report found were caused by smoking. Early 
data show that calls to state tobacco quitlines increased by nearly 70 
percent in the first few weeks of the ads running. In fiscal year 2016, 
CDC plans to continue with the Tips campaign with a new round of ads 
featuring additional health conditions. CDC anticipates running these 
ads in the first quarter of 2016.
    Question. What effect will the rise in e-cigarette use among youth, 
documented in a CDC report released last week, have on our tobacco 
control gains?
    Answer. Recent increases in e-cigarette and hookah use, combined 
with declines in use of more traditional products such as cigarettes 
and cigars, resulted in no change in overall tobacco use between 2013 
and 2014. The report also concludes that because the use of e-
cigarettes and hookahs is on the rise among middle and high school 
students, it is critical that comprehensive tobacco control and 
prevention strategies for youth focus on all tobacco products, and not 
just cigarettes. FDA is working to finalize the proposed deeming rule 
on tobacco products and proposes extending its regulatory authority to 
cover additional products that meet the definition of a tobacco 
product, including e-cigarettes and hookah. Once the proposed rule 
becomes final, FDA will be able to take further action to reduce youth 
tobacco use and initiation through use its regulatory tools, such as 
age restrictions and rigorous scientific review of new tobacco 
products. FDA's regulation of tobacco products will complement other, 
proven tobacco control strategies to achieve our objective of 
prevention of all forms of youth tobacco use.
                          hiv/aids prevention
    Question. For several years, CDC has been emphasizing HIV testing 
to help control the transmission of HIV, as well as to connect people 
with HIV to treatment. These efforts have resulted in an increase in 
people with HIV who are aware of their condition from 75 percent in 
2001 to 86 percent a decade later. Yet the rate of new infections has 
remained stable in recent years, at about 50,000 new HIV infections per 
year. And some groups are affected more than others. Among races and 
ethnicities, African Americans continue to be disproportionately 
affected. So much more remains to be done to prevent HIV transmission. 
What factors are impeding our efforts to reduce the number of new cases 
below 50,000 each year? What more can we do to bring down the number of 
new cases?
    Answer. As the number of people living with HIV increases due to 
better, life-prolonging treatments, so do opportunities for HIV 
transmission. The number of new infections has remained stable even as 
the number of persons living with HIV has increased. CDC estimates that 
that there are only four transmissions per year for every 100 people 
living with HIV in the United States, an 89 percent decline since the 
mid-1980s; there was a 9 percent decrease between 2006 and 2010 alone. 
This achievement reflects the combined impact of investments in 
testing, prevention, and treatment.
    To continue efforts to reduce the number of new cases and achieve 
the national prevention goals of the National HIV/AIDS Strategy, we 
must continue working towards: improving the utilization of effective 
primary prevention tools designed to prevent HIV infection, including 
pre-exposure prophylaxis; diagnosing people with HIV early; linking 
newly-diagnosed people as soon as possible to HIV medical care; 
supporting HIV prevention partners to ensure patients receive ongoing 
HIV medical care and achieve viral suppression; gaining a better 
understanding of factors that drive health disparities; and ensuring 
that young people have the knowledge and skills to avoid infection and 
establish healthy behaviors for a lifetime.
    To further decrease the number of new cases, the fiscal year 2016 
Budget proposes to expand existing CDC research and surveillance 
efforts within the $6 million increase requested for HIV activities to 
better understanding the characteristics of persons at risk of 
transmitting HIV. This year, CDC released first-ever estimates of 
transmission at each stage of the HIV care continuum that showed:
  --Nine in 10 new HIV infections come from people not receiving care.
  --People who were successfully keeping the virus under control were 
        94 percent less likely than those who did not know they were 
        infected to transmit HIV.
    These data support CDC's efforts to prioritize funding for 
prevention services for persons living with HIV, including linkage to 
care, retention and re-engagement in care, and adherence to HIV 
treatments to achieve the ultimate goal of viral suppression, and in 
turn, fewer new HIV cases.
    To prevent acquisition of HIV, CDC is also investing in primary 
prevention efforts, including biomedical and behavioral risk reduction 
interventions, for persons at highest risk. These efforts--some of 
which would be funded with the increase requested in the fiscal year 
2016 Budget for HIV activities --include implementation of pre-exposure 
prophylaxis (e.g., planning, educational materials, risk reduction 
counseling, evaluation, and staffing). With pre-exposure prophylaxis, a 
person who does not have HIV takes medicine to prevent acquiring HIV. 
When used consistently, pre-exposure prophylaxis has been shown to 
greatly reduce acquisition of HIV infection in people who are at 
substantial risk. In 2014, CDC released clinical guidelines 
recommending pre-exposure prophylaxis. If targeted to the right 
populations (e.g., couples where one person is HIV-positive and one is 
HIV-negative) and used in the right way, pre-exposure prophylaxis has 
the potential to alter the course of HIV in the United States.
    Young people aged 13--24 accounted for a disproportionate 
percentage of all new HIV infections in the United States (26 percent 
in 2010), and adolescents report inconsistent use of condoms and may 
not seek health services because of unique barriers that particularly 
hinder use of sexual health services. The fiscal year 2016 Budget 
requests an additional $6 million above the fiscal year 2015 Enacted 
level to evaluate and improve school HIV prevention activities and 
increase outreach strategies and interventions for youth at 
disproportionate risk for HIV infection, including adolescent men who 
have sex with men.
       fiscal year 2016 budget request for cms program management
    Question. The President's budget maintains investments in CMS to 
help families get affordable healthcare through the ACA Health 
Insurance Marketplace. The CMS appropriation is also the primary 
account that operates the Medicare program, helping seniors get the 
care they need. Both the growing Medicare population and the important 
initiatives to encourage high-quality care are significant undertakings 
for the agency, which is why the budget proposes additional resources 
to support the increasing workload. Of the $4.3 billion requested for 
CMS, what proportion of the budget supports Medicare Operations and 
what are some of these critical functions? Significant growth in the 
long term care industry has not been matched with increased funding to 
support CMS' oversight activities that protect seniors. What will be 
the impact if the Survey and Certification program does not get 
additional funding this year?
    Answer. The fiscal year 2016 CMS Program Management request is $4.2 
billion, an increase of $270 million above fiscal year 2015. This 
request will enable CMS to enhance and continue to effectively 
administer Medicare, Medicaid, and the Children's Health Insurance 
Program, as well as health insurance reforms contained in the 
Affordable Care Act. Of this amount, CMS is requesting $3 billion for 
Program Operations, an increase of $200 million above the fiscal year 
2015 level. Approximately 30 percent, or $899 million, of the Program 
Operations request supports ongoing contractor operations such as 
Medicare claims processing. For fiscal year 2016, the Budget requests 
$784 million for CMS Federal Administrative costs, $51 million above 
the fiscal year 2015 enacted level. Of this total, $686 million will 
support a full-time equivalent (FTE) level of 4,671, an increase of 201 
FTEs over fiscal year 2015. This staffing increase will enable CMS to 
address the needs of a growing Medicare population, as well as oversee 
expanded responsibilities resulting from the Affordable Care Act and 
other legislation passed in recent years.
    The fiscal year 2016 Survey and Certification request is $437 
million, a $40 million increase over fiscal year 2015. The increased 
funding level supports survey frequency levels in response to 
increasing numbers of participating facilities and improved quality and 
safety standards. This increase also provides targeted funding for the 
most serious quality of care concerns by increasing nursing home 
special focus facility work and enhancing quality monitoring and 
oversight in the States, territories, islands, and IHS facilities 
within tribal nations. CMS expects States to complete over 25,000 
initial surveys and re-certifications and over 52,000 visits in 
response to complaints in fiscal year 2016. The Improving Medicare 
Post-Acute Care Transformation Act of 2014 increases hospice survey 
frequencies to no less than once every 3 years. Approximately 87 
percent of the request will go to State survey agencies. Surveys 
include mandated Federal inspections of long-term care facilities 
(i.e., nursing homes) and home health agencies, as well as Federal 
inspections of other key facilities. All facilities participating in 
the Medicare and Medicaid programs must undergo inspection when 
entering the program and on a regular basis thereafter. In addition, 
CMS is currently engaged in an effectiveness and efficiency strategy 
aimed at quality improvement while identifying risk-based approaches to 
surveying.
          teenage use of long-acting reversible contraception
    Question. Though teen pregnancy rates continue to decline, it is 
troubling that roughly 1 million teenage girls still become pregnant 
every year. The United States experiences much higher rates than many 
other developed nations. In fact, the rate of teen pregnancy in the 
U.S. is twice as high as in England and nine times as high as Japan and 
the Netherlands. According to a recent CDC report, nearly 90 percent of 
teens used birth control the last time they had sex. Unfortunately, 
very few teens are using the most effective forms of birth control, 
IUDs and implants, which are known as Long-Acting Reversible 
Contraception (LARC). What are the major barriers that prevent teens 
from using LARCs at higher rates? How is HHS working to increase 
awareness, access, and availability of these types of contraception 
among teens?
    Answer. Research has identified numerous barriers to adolescents' 
use of LARC (see citations below). Barriers include the fact that many 
teens know very little about LARC, and that some teens mistakenly think 
they cannot use IUDs because of their age. Clinics report many barriers 
to providing LARC to teens, including high upfront costs for supplies, 
lack of awareness among providers about the safety and effectiveness of 
LARC for teens, providers lack training on insertion and removal of 
LARC, and/or providers lack training on a client-centered counseling 
approach that includes discussing the most effective contraceptive 
methods first.
    HHS is taking several steps to remove these barriers to LARC, among 
teens and all women of reproductive age:
  --The Affordable Care Act removed many cost barriers to LARC when it 
        provided for inclusion in most health coverage of certain 
        women's preventive services without co-pay or deductibles. As 
        identified in comprehensive guidelines supported by the Health 
        Resources and Services Administration, these preventive 
        services required to be covered without cost sharing include 
        contraceptive services for women with reproductive capacity.
  --HHS supports the provision of confidential, low cost 
        contraception--including LARC--through the Title X program. 
        Since 1970, the Title X program has provided cost-effective and 
        confidential family planning and related preventive health 
        services for low-income women and men. Title X funded centers 
        serve approximately 4.7 million clients, including one million 
        teens each year (about 20 percent of clients are teens). The 
        program requires funded centers to encourage parent-child 
        communication, counsel minors about sexual coercion, and 
        observe all relevant State laws and any legal obligations, such 
        as notification or reporting of child abuse, child molestation, 
        sexual abuse, rape or incest, as well as human trafficking.
  --In 2014, the HHS Office of Population Affairs (OPA), which 
        administers the Title X program, partnered with the Centers for 
        Disease Control and Prevention (CDC) to publish national 
        guidelines about how to provide quality family planning 
        services, which clarify LARC is safe and effective for teens 
        and describe how to meet the unique needs of adolescent 
        clients. The guidelines also recommend counseling procedures 
        that ensure contraception is offered in a client-centered way. 
        Numerous efforts are being taken to increase awareness of these 
        clinical guidelines to all providers of primary care.
  --The Title X program funds five national training centers to ensure 
        that Title X providers (and others) have the skills and 
        knowledge needed to implement the guidelines for family 
        planning services. This effort includes training focused on 
        counseling about LARC, LARC insertion, and contraceptive 
        counseling among teens. More information about training 
        resources can be found at www.fpntc.org.
  --The Center for Medicaid and Children's Health Insurance Program 
        (CHIP) Services' (CMCS) Maternal and Infant Health Program 
        includes teens in its efforts to improve maternal and infant 
        health. Preventing unintended pregnancy is one of two key 
        strategies of this initiative. Several approaches to removing 
        barriers to LARC are being considered, including reimbursement 
        rates, expanding coverage for services such as immediate 
        postpartum insertion of LARC, removing barriers to same-day 
        provision of LARC such as prior authorization, and discouraging 
        medical management techniques such as requiring clients to 
        ``fail'' on another method before approving LARC. For more 
        information, see: http://www.medicaid.gov/Medicaid-CHIP-
        Program-Information/By-Topics/Quality-of-Care/Maternal-and-
        Infant-Health-Care-Quality.html.
  --OPA is also taking steps to develop/validate clinical performance 
        measures for contraceptive services, which can be used in the 
        context of quality improvement efforts to improve the quality 
        of contraceptive care that is provided. One of the measures 
        focuses on the percentage of adolescent women at risk of 
        unintended pregnancy that use LARC. While still under 
        development, OPA expects to submit these measures to the 
        National Quality Forum for endorsement this summer, and several 
        Federal programs that address teen pregnancy prevention have 
        already started using this measure on a developmental basis 
        (i.e., Title X, the Center for Medicaid and CHIP Services' 
        Maternal and Infant Health Program, and HRSA's Collaborative 
        Improvement and Innovation Network (CoIIN) to Reduce Infant 
        Mortality).
    References:
  --Kavanaugh ML, Frohwirth L, Jerman J, Popkin R, Ethier K. Long-
        acting reversible contraception for adolescents and young 
        adults: patient and provider perspectives. J Pediatr Adolesc 
        Gynecol 2013;26:86--95.
  --Kavanaugh ML, Jerman J, Ethier K, Moskosky S. Meeting the 
        contraceptive needs of teens and young adults: youth-friendly 
        and long-acting reversible contraceptive services in U.S. 
        family planning facilities. J Adolesc Health 2013;52:284--92.
  --Fleming KL, Sokoloff A, Raine TR: Attitudes and beliefs about the 
        intrauterine device among teenagers and young women. 
        Contraception 2010; 82:178.
  --Spies EL, Askelson NM, Gelman E, et al: Young women's knowledge, 
        attitudes, and behaviors related to long-acting reversible 
        contraceptives. Womens Health Issues 2010.
                      older americans act programs
    Question. Over the next 20 years, nearly 80 million baby boomers 
will reach retirement age and older Americans will comprise roughly 20 
percent of our population. It is unacceptable that Federal investments 
for critical programs that help older adults live safely at home and 
eat nutritiously have fallen significantly behind inflation and the 
increasing population. These programs, like Meals on Wheels, not only 
allow seniors to remain in their homes, but help avoid high medical and 
long term care costs that significantly impact Medicaid and Medicare. 
How will seniors in need of nutrition and supportive services be 
impacted if the budget for these Older Americans Act programs remains 
stagnate next year?
    Answer. ACL Nutrition Services programs, as well as ACL Home and 
Community-Based Supportive Services programs, help elderly Americans 
live at home for longer, delaying the need for much more expensive 
institutional services.
    ACL has requested $40 million in increased funding for Nutrition 
Services and $38 million in increased funding for Home and Community-
Based Supportive Services in fiscal year 2016 to counteract the 
negative impact on service levels of rising food, labor, and fuel 
costs.
    With regard to Nutrition Services, the Budget--in combination with 
State and local funding-- will support approximately 208 million home-
delivered and congregate meals to more than 2.3 million elderly 
Americans in fiscal year 2016, which will allow ACL to maintain 
approximately the same level of meals as is currently projected for 
fiscal year 2015, halting the decline in service levels for the first 
time since 2009-2010, when these programs received a one-time funding 
increase from the American Recovery and Reinvestment Act. If fiscal 
year 2016 funding for ACL Nutrition Services is ultimately held flat 
with fiscal year 2015 funding levels, however, millions of fewer meals 
may be served as a result.
    With regard to Home and Community-Based Supportive Services, the 
Budget--in combination with State and local funding--will support 
increases for a variety of services levels, including those for 
transportation services; personal care, homemaker, and chore services; 
and adult day care services. If fiscal year 2016 funding for Home and 
Community-Based Supportive Services is ultimately held flat with fiscal 
year 2015 funding levels, an estimated 500,000 fewer rides to doctors 
and grocery stores, 200,000 fewer hours of assistance to seniors unable 
to perform activities of daily living, and 100,000 fewer hours of care 
for dependent adults in supervised, protective group settings may 
ultimately be provided as a result.
    Without the additional resources requested in the Budget, more 
older adults will be at risk of no longer being able to live at home.
                                 ______
                                 
                Question Submitted by Senator Jack Reed
       cdc's healthy homes and lead poisoning prevention program
    Question. I have been advocating for the full restoration of CDC's 
healthy homes/lead poisoning prevention program. Addressing 
environmental causes of health can lead to improved health outcomes and 
major cost savings. Lead poisoning, for example, costs society $50 
billion annually in healthcare, education, and other costs. We have the 
know-how to prevent lead poisoning and I am pleased that Congress 
restored some of the funding for this program in fiscal years 2014 and 
2015.
    Can you tell us what your plans are for the program this year and 
what you would do with additional resources?
    Answer. Lead poisoning poses a health, social, and economic burden 
for families, communities, and the country. CDC's Healthy Homes and 
Lead Poisoning Prevention Program protects children from lead exposure 
and provides national expertise, guidance, and surveillance of 
childhood lead poisoning in the United States. The fiscal year 2016 
Budget includes $16 million for this program and will build on past 
success in reducing children's blood lead levels in the United States.
    In fiscal year 2016, CDC will fund 35 State and local lead 
poisoning prevention programs to implement proven primary prevention 
interventions that protect children who live in the highest-risk 
housing. Examples of these interventions include: housing 
rehabilitation, housing and health code enforcement, early childhood 
programs, and publishing guidelines to help healthcare providers 
identify and manage children with elevated blood lead levels. These 
interventions are based on CDC-funded data collection, and protect 
children who live in the highest-risk housing in buildings, blocks, and 
neighborhoods.
                                 ______
                                 
             Questions Submitted by Senator Jeanne Shaheen
                      prevention of opioid misuse
    Question. Prescription drug abuse is a serious public health 
problem in New Hampshire, and across the country. And we know that 
certain prescription drugs can lead to a variety of adverse health 
effects, including addiction. In New Hampshire, we are seeing the 
impact of addiction problems. I was pleased to see that your budget 
includes investments on prescription drug abuse and overdose 
prevention. I have introduced a bi-partisan, bi-cameral bill to 
reauthorize the National All Schedules Prescription Electronic 
Reporting Act which would improve prescription drug monitoring programs 
across the country.
    What role to do see prescription drug monitoring programs playing 
in addressing the prescription drug abuse, and what more is the 
administration doing to help educate healthcare providers about 
appropriate narcotic prescription drug dispensement?
    Answer. Prescription drug monitoring programs play an important 
role in combatting prescription drug abuse. The Department recently 
launched a targeted initiative aimed at reducing prescription opioid 
and heroin related overdose, death and dependence. The Department's 
fiscal year 2016 Budget provides $131 million, an increase of $99 
million above fiscal year 2015, to address this critical issue. The 
Budget includes $65 million, an increase of $45 million above fiscal 
year 2015, proposed in CDC to expand the Prescription Drug Overdose 
Prevention for States program to fund all 50 States and Washington, 
D.C. for a truly comprehensive response to the national epidemic. This 
funding will provide grants to help implement tailored, State-based 
prevention strategies such as maximizing the use of prescription drug 
monitoring programs, enhancing public insurer mechanisms to prevent 
overdoses, and evaluating their own policies and programs aimed at 
addressing the epidemic. This will be accomplished in part by promoting 
best practices in PDMPs among State grantees. For example, proposed 
systems improvements include:
  --Interstate prescription drug monitoring program interoperability;
  --Improved proactive reporting and links to other systems such as 
        Medicaid; and
  --National patient safety improvements and improvements in data 
        quality and monitoring, with an emphasis on real-time mortality 
        data.
    Also within this initiative, CDC will lead the development of new 
opioid prescribing guidelines for non-cancer chronic pain which will 
help prescribers know how and when to safely and appropriately 
prescribe opioids. CDC and SAMHSA will improve State prevention 
programs by helping States understand how to use prescription drug 
monitoring programs, strategic planning, and other existing data 
systems in prevention planning, and ONC will fund challenge awards to 
innovate the design and use of health information technology products 
to access prescription drug monitoring programs in live clinical 
applications.
                 diabetes prevention, research and care
    Question. I am concerned that we are missing the mark in 
translating the incredible diabetes research being done across the 
Federal Government into clinical care initiatives for healthcare 
providers use. Senator Collins and I have legislation to create a 
Diabetes Clinical Care Commission that would bring together experts in 
diabetes care, patients, and the agencies in the Federal Government 
that work on diabetes to work together on these issues of better 
clinical care for people with pre-diabetes, diabetes and the diseases 
that are complications of diabetes. I welcome your comments on such a 
commission, as well as what steps this budget takes to address the 
diabetes epidemic, which has such a huge humanitarian and financial 
toll on patients and the healthcare system.
    Answer. Diabetes research, prevention, and care are an important 
priority for the Department. About 29 million Americans have diabetes, 
and over 200,000 die each year of related complications. To foster 
collaboration among various Federal agencies addressing diabetes, the 
Diabetes Mellitus Interagency Coordinating Committee (DMICC) was 
established to ensure coordination across Federal efforts to prevent 
and treat diabetes. There are over thirty Federal agencies who are 
members in the DMICC. The missions of these agencies and approaches to 
the diabetes epidemic are complementary and informed by stakeholder 
input linking basic research; investigating the cause of diabetes and 
identifying targets for therapy; clinical trials; translation of new 
knowledge into clinical practice and health decisionmaking; delivery of 
healthcare services and public health interventions; and optimizing 
healthcare access, delivery and public health measures. The DMICC is 
one vehicle through which agencies within the Department of Health and 
Human Services provide leadership and coordination between government 
agencies in order to avoid duplication of efforts and to maximize 
scarce resources. The DMICC currently carries out the activities 
proposed under the National Diabetes Clinical Care Commission, but I 
would be happy to work with you on ways in which the DMICC's work could 
be further strengthened.
    The Budget request builds on recent progress made to address 
diabetes by including $10.9 billion in funding across the Department 
for diabetes care and related research, an increase of $1.1 billion 
over fiscal year 2015. Highlights of these investments include:
  --The fiscal year 2016 Budget proposes a 3-year extension of the 
        Special Diabetes Program for Type 1 Diabetes and for Indians 
        (through fiscal year 2018), at $150 million per year for each 
        of the two programs. These programs support research at the 
        National Institutes of Health and implementation of proven 
        interventions in Indian Country. The recently-enacted SGR law 
        (Medicare Access and CHIP Reauthorization Act of 2015, Public 
        Law 114-10) extended funding for these important programs 
        through fiscal year 2017.
  --The Budget continues support for CDC's National Diabetes Prevention 
        Program with an investment of $10 million, the same as fiscal 
        year 2015. The National Diabetes Prevention Program is an 
        evidence-based lifestyle intervention program for preventing 
        type 2 diabetes that teaches participants strategies for 
        incorporating physical activity into daily life and eating 
        healthy. NIH studies have shown that lifestyle changes, such as 
        diet and physical activity, can lower the risk of developing 
        type 2 diabetes by over 50 percent in adults at high risk for 
        the disease.
  --HRSA's Health Centers Program is making strides in diabetes care 
        and control for adult patients. The Budget's proposal to expand 
        the capacity of health centers will help drive greater strides 
        in diabetes care and control for adult patients. The recently-
        enacted SGR law extends funding for these health centers. In 
        2013, 69 percent of health center patients with diabetes had 
        their diabetes under control, exceeding the Medicaid HMO 
        average of 55 percent. For example, in New Hampshire, about 83 
        percent of diabetic health center patients have their diabetes 
        under control.
           low income home energy assistance program (liheap)
    Question. As you know, the Low Income Home Energy Assistance 
Program (LIHEAP) is the main Federal program to help low-income 
households and seniors with their energy bills, providing vital 
assistance during both the winter and summer months.
    I understand that HHS held back roughly $34 million in LIHEAP 
funding from fiscal year 2015. If true, will those be distributed to 
States soon? The funds could particularly help States like New 
Hampshire that are recovering from the tough winter we experienced this 
year.
    Answer. LIHEAP is a lifeline for many vulnerable Americans who 
often have to make tough choices within their household budgets. We 
expect that remaining LIHEAP funds will be distributed to States before 
the end of the third quarter of fiscal year 2015.
    Question. In this budget request, you are asking for $200 million 
to go toward a LIHEAP innovation program. I am concerned that this may 
take funds away from the core function of the program at a time when 
many households who are eligible for the program are not receiving 
funds. I am also concerned about the use of fuel switching in the 
innovation program. If you do move forward with this program, what 
steps will you take to ensure that it would be implemented in a way 
that my oil-heat constituent can still maximize their access to the 
program?
    Answer. The Utility Innovation Fund will support efforts to better 
reduce low-income households' utility bills over the long-term. ACF 
will provide $200 million in competitive grants to current LIHEAP 
grantees to encourage partnerships with utilities and community-based 
organizations to test innovative strategies to reduce the home energy 
burden of the highest burden low income households. For example, the 
competitive funds may support efforts to test strategies related to 
reducing energy burden, supporting more efficient and clean energy 
sources, and improving households' ability to pay utility costs. Each 
grantee will be required to conduct a rigorous evaluation to develop 
lessons learned and, to the extent possible, assess the efficacy of 
interventions. HHS does not prioritize specific fuel types nor is it 
our intent to designate a preferred fuel type. Instead grantees would 
assess the home's energy use and recommend cost-effective measures to 
make that home more energy efficient.
                                 ______
                                 
              Questions Submitted by Senator Brain Schatz
                 telehealth services and reimbursement
    Question. My understanding is that the CMS Innovation Center can 
waive Medicare restrictions on telehealth for various initiatives and 
experiments. For example, in the Next Generation ACO program, CMS 
waived the 1834(m) restrictions on geographic location and where the 
patient can be located during telehealth visits. However, CMS did not 
lift the restrictions on store-and-forward technologies, on provision 
of telehealth services by occupational and speech therapists, and more. 
Can you please tell me why not, and what more is being done to expand 
telehealth initiatives from the perspective of the Innovation Center?
    Answer. The telehealth waiver in the Next Generation ACO Model 
addressed the originating site requirement, which was the barrier most 
often cited by commenters in response to CMS' Request for Information 
on this payment policy. CMS remains open to exploring waivers of 
additional elements of payment for telehealth services in later years 
of the Next Generation Model and/or in other Innovation Center models, 
and will consult with the Office of the National Coordinator for Health 
Information Technology in these policy discussions.
    Question. The Medicare, Medicaid, and SCHIP Benefits Improvement 
and Protection Act of 2000, or BIPA, in Section 223, required HHS to 
conduct a study to identify several important topics within telehealth 
services and reimbursement. The law required that a report be submitted 
to Congress no later than 2 years after it was passed, but to our 
knowledge no report has been issued. Can we count on CMS to submit this 
report by January 19, 2017, before a new Administration begins?
    Answer. The Medicare, Medicaid, and SCHIP Benefits Improvement and 
Protection Act of 2000, or BIPA, requires HHS to study whether there 
are additional practitioners, settings or sites, or geographic areas 
that should be included under the telehealth benefit. The Centers for 
Medicare & Medicaid Services (CMS) has addressed this requirement 
through changes in law or regulations resulting in the addition of 
practitioners, settings, sites, and geographic areas to the telehealth 
benefit. For instance, Congress added telehealth originating sites 
through Section 149 of MIPPA 2008, which added Skilled Nursing 
Facilities, End Stage Renal Disease facilities, and Community Mental 
Health Centers. Medicare has continued to grow the telehealth program 
since its inception in 2004. There are now 75 services that can be 
furnished via telehealth. Since 2004, CMS has added numerous services 
to the list including preventive services, transitional care 
management, and new psychiatric services. In CY 2012, CMS also 
broadened our criteria for adding new services to the list. Effective 
July 5, 2011, CMS implemented rules to permit hospitals and Critical 
Access Hospitals (CAHs) to provide telemedicine services to their 
patients through written agreements with a distant-site hospital or a 
distant-site telemedicine entity. Further, CMS streamlined 
credentialing and privileging for telemedicine physicians and 
practitioners in CAHs, and effective in CY 2014, CMS modified our 
regulations regarding originating sites to define rural Health 
Professional Shortage Areas as those located in rural census tracts as 
determined by the Office of Rural Health Policy. Adopting the more 
precise definition of ``rural'' for this purpose expanded access to 
healthcare services for Medicare beneficiaries located in rural areas. 
Finally, in CY 2014, CMS revised our policy to so that geographic 
eligibility for an originating site would be established and maintained 
on an annual basis, consistent with other telehealth payment policies. 
We are happy to work with Congress on exploring additional 
practitioners and geographic areas that may be appropriate for 
inclusion under the telehealth benefit.
    Question. While Medicare has abundant regulations on telehealth 
reimbursement, Medicaid does not. As such, States have been able to 
experiment with multiple payment and incentive schemes in telehealth. 
What has CMS learned from the vast experience on the Medicaid side with 
telehealth that could apply to Medicare?
    Answer. Telemedicine is an important part of the healthcare 
delivery system and can improve access to care for all patients, 
particularly those rural or underserved populations. CMS is working 
across its programs to ensure access to high quality care through a 
variety of tools, including telemedicine.
    The Medicare program provides telehealth services for Medicare 
beneficiaries for a limited number of Part B (outpatient) services 
furnished through a telecommunications system by a physician or 
practitioner to an eligible telehealth individual, where the physician 
or practitioner providing the service is not at the same location as 
the beneficiary. The Medicare Shared Savings Program statute encourages 
accountable care organizations (ACOs) to coordinate care through the 
use of telehealth, remote patient monitoring, and other such enabling 
technologies. ACOs participating in the Shared Savings Program and the 
Pioneer ACO Model are encouraged to use these technologies.
    In Medicaid, States are encouraged to use the flexibility in the 
program law to create innovative payment methodologies for services 
that incorporate telemedicine technology.
    While the current Federal Medicaid statute does not recognize 
telemedicine as a distinct service, States have the option/flexibility 
to determine whether (or not) to cover telemedicine; what types of 
telemedicine to cover; where in the State it can be covered; how it is 
provided/covered; what types of telemedicine practitioners/providers 
may be covered/reimbursed, as long as such practitioners/providers are 
``recognized'' and qualified according to Medicaid statute/regulation; 
and how much to reimburse for telemedicine services, as long as such 
payments do not exceed Federal Upper Limits.
    To further facilitate the use of telemedicine, States are not 
required to submit a (separate) SPA for coverage or reimbursement of 
telemedicine services, if they decide to reimburse for telemedicine 
services the same way/amount that they pay for face-to-face services/
visits/consultations.
    CMS will continue to work across our programs and in collaboration 
with the Office of the National Coordinator for Health Information 
Technology to utilize technological advances, such as telemedicine to 
ensure all Americans have access to high-quality healthcare.
    Question. Hawaii faces significant issues with the impact of 
immigrants from the Compact of Free Association (COFA) States. 
Telehealth may be a mechanism to mitigate this impact by allowing 
potential immigrants to stay in their own countries. Has CMS examined 
the use of telehealth to mitigate the Compact impact?
    Answer. In limited circumstances, Federal law extends Medicaid 
eligibility to certain citizens of nations that have a Compact of Free 
Association (COFA) with the United States at a state's option. As you 
know, Hawaii has taken up that option and extends Medicaid benefits to 
lawfully residing children and pregnant women. Beyond Medicaid, COFA 
migrants are eligible to purchase health insurance and receive Federal 
tax credits and cost-sharing reduction (APTC/CSR) through the state's 
health insurance exchange, the Hawaii Health Connector.
    In Medicaid, States are encouraged to use the flexibility in the 
program law to create innovative payment methodologies for services 
that incorporate telemedicine technology and are not required to submit 
a (separate) State plan amendment (SPA) for coverage or reimbursement 
of telemedicine services, if they decide to reimburse for telemedicine 
services the same way/amount that they pay for face-to-face services/
visits/consultations.
    Question. In order for telehealth to expand, robust data on 
utilization and outcomes is needed. What mechanisms are currently 
underway to track telehealth utilization and outcomes in Medicare and 
Medicaid, and then to disseminate the findings?
    Answer. The Health Care Innovation Awards (HCIA) have several 
awardees that are using telehealth as part of their intervention. 
Telehealth is being used in different settings and targeting different 
acute and chronic conditions. Telehealth activities under Round 1 of 
HCIA are being evaluated by independent evaluation contractors. 
Findings to date are mostly qualitative and describe implementation 
experiences due to the availability of data. For awardees with a 
telehealth component in their interventions, the contractors will 
continue to collect telehealth utilization and selected outcome 
measures to the extent that the data is available. However, the 
findings will be limited by data availability and the sample size for 
most of these awardees. The Innovation Center anticipates releasing the 
next set of evaluation findings for Round 1 of HCIA next year. We look 
forward to learning about telehealth from future findings about these 
awards.
    In addition to the HCIA awards, the Innovation Center will be 
evaluating the Next Generation ACO Model, which includes a waiver of 
telehealth payment rules, yielding descriptive data on utilization of 
telehealth services, and not outcomes. We are happy to work with 
Congress on exploring additional ways to promote and/or expand 
telehealth services.
                                 ______
                                 
              Questions Submitted by Senator Tammy Baldwin
                      wisconsin's medicaid waiver
    Question. Instead of expanding Wisconsin's Medicaid program, 
BadgerCare, under the ACA, our Republican Governor kicked almost 63,000 
individuals off of their Medicaid coverage and into the ACA's 
Marketplace. As you know, I worked with CMS to include terms and 
conditions in Wisconsin's Medicaid waiver that required our Governor 
and CMS to track the Wisconsinites he kicked off BadgerCare to hold him 
accountable for those who may not have successfully obtained 
Marketplace coverage.
    Now that the second ACA open enrollment period has closed, when 
will you have the updated data on the number of Wisconsinites who have 
successfully made the transition to Marketplace coverage?
    Answer. My understanding is that, since the transition, CMS has 
shared Marketplace enrollment data with the State on two occasions and 
in between the period of those data matches, a Special Enrollment 
Period was provided for Wisconsinites who had lost Medicaid coverage 
and had not transitioned to Marketplace coverage.
    CMS in the process of working with the State to provide an 
additional Marketplace data set and the parameters around the use of 
that data, though CMS believes that the State has fulfilled its 
obligations under its 1115 Waiver Transition Plan and that no further 
data matches are required.
    As you note, as a requirement to meet its 1115 Waiver Transition 
Plan, Wisconsin conducted multiple rounds of outreach to the nearly 
63,000 individuals you mention to help provide for a seamless 
transition to coverage available through the Marketplace. As part of 
this effort, the State sent several letters to transitioning members 
that included information about enrolling in Marketplace coverage, 
conducted multiple rounds of outreach calls encouraging these 
individuals to apply to the Marketplace, and shared information through 
its ``Regional Enrollment Network.''
                 hhs' response to indiana hiv epidemic
    Question. I am alarmed by the recent, tragic situation in Indiana, 
where there have been 130 cases of HIV identified based on injection 
drug use in the last 3 months. According to the CDC, the majority of 
cases were linked to syringe-sharing partners injecting prescription 
opioids. Not only does this crisis highlight the urgency in addressing 
the prescription drug abuse epidemic, but the need to increase our 
efforts to contain HIV, including by expanding efforts to promote the 
use of clean needles.
    I have long supported ending the ban on the use of Federal funds 
for syringe exchange programs. Numerous studies have shown syringe 
exchange programs can be an evidence-based and cost-effective means to 
lower HIV and hepatitis infections, reduce the use of illegal drugs and 
help connect people to medical treatment, including substance use 
treatment.
    What is the CDC doing to help address the crisis in Indiana and to 
advance injection safety, particularly for individuals living with HIV?
    Answer. The Indiana State Health Department has the lead in the 
response effort to the HIV outbreak in Scott County, which appears to 
be driven by intravenous use of opioid prescription painkillers. 
Several HHS agencies including CDC, HRSA, SAMHSA and FDA, are working 
closely with Indiana officials and providing assistance.
    The Department, and the Administration, is committed to making the 
dream of an AIDS-free generation a reality through our efforts to 
better prevent and treat HIV. Because opioid use appears to be the main 
driver of the current Indiana outbreak, I also want to underscore that 
combatting opioid abuse is a top priority at the Department of Health 
and Human Services. We believe that through evidence-informed 
interventions and bipartisan solutions we can put a stop to opioid 
drug-related dependence and overdose.
    CDC is assisting with the Indiana investigation at the request of 
State health officials, who are leading the response and have reacted 
promptly to a severe, rapidly spreading-outbreak. CDC is leading 
epidemiological and surveillance efforts and is also assisting with HIV 
testing in the community. CDC currently has several experts in the 
field. CDC expects to continue to work closely on-the-ground with our 
colleagues in Indiana for as long as they need assistance. Specific CDC 
activities include:
  --Efforts to diagnose those infected with HIV and link them to needed 
        medical care, including collecting blood samples for the State 
        laboratory to use in testing for hepatitis (B and C), syphilis, 
        and tuberculosis;
  --Conducting interviews with those infected with HIV to identify 
        additional contacts who need to be reached with testing and 
        linked to care and treatment, if also infected;
  --Laboratory testing of specimens to help determine how recently 
        infections occurred and to identify clusters of infection; and
  --Educational efforts to reach healthcare providers and those at risk 
        with education efforts and referrals to prevention services, 
        including pre-exposure prophylaxis, post-exposure prophylaxis, 
        syringe exchange services, and drug treatment programs;
    Please also see:
  --CDC's Health Advisory: http://emergency.cdc.gov/han/han00377.asp
  --Morbidity and Mortality Weekly Report (MMWR): http://www.cdc.gov/
        mmwr/preview/mmwrhtml/mm6416a4.htm?s cid=mmmm6416a4 w
    Question. What are the consequences if Congress continues the ban 
on the use of Federal funds for syringe exchange?
    Answer. As you stated, Federal funding cannot be used for syringe 
exchange programs due to a Congressional ban. States may use other 
available sources of funding to support such programs in their States, 
consistent with State and local law.
    Scientific evidence has found that syringe exchange programs can 
reduce needle sharing among drug users, resulting in positive behavior 
change that can reduce transmission of HIV and other blood-borne 
infections. The evidence shows that syringe exchange programs do not 
result in negative consequences such as increases in injection 
frequency, in injection drug use, or in unsafe disposal of needles in 
the community. In fact, syringe exchange programs can provide a 
positive pathway to prevention for substance abusing persons. Many 
communities have found syringe exchange programs to be an effective 
component of their HIV prevention efforts for the injection drug user 
population.
    The Administration supports a consistent policy that would allow 
Federal funds to be used in locations where local authorities deem 
syringe exchange programs to be effective and appropriate. This policy 
is reflected again in the fiscal year 2016 President's Budget. Without 
Federal support for syringe exchange programs, HHS is not able to 
leverage all opportunities to reduce HIV and hepatitis C infections, 
prevent overdose deaths, and link people to drug treatment programs. A 
recent study from Bramson et al. published on January 15, 2015 in the 
Journal of Public Health Policy (Vol. 36, 2, 212-230) found that, in 
the States examined where State and local funding for Syringe Services 
Programs (SSPs) was provided, estimated HIV incidence remained low over 
time or decreased. We will continue to work with Congress on this 
important issue.
      national breast and cervical cancer early detection program
    Question. In 2007, I was the lead author of the National Breast and 
Cervical Cancer Early Detection Program Reauthorization Act in the 
House, with my colleague Vice Chairwoman Mikulski in the Senate. I am 
committed to protecting and enhancing this critical program so that 
vulnerable women have access to lifesaving screening services, and so I 
am extremely frustrated that your Budget--once again--requests 
significant cuts for this program.
    Despite increased access to screenings under the ACA, many women 
still face significant barriers to obtaining essential cancer 
screenings and remain eligible under the program, so why does the 
Administration continue to propose these harmful cuts?
    Answer. With the proposed funding level for fiscal year 2016, CDC's 
cancer screening programs will continue to complement the benefits 
provided through the Affordable Care Act. CDC will continue to support 
the provision of direct services to people who are not covered by 
insurance, but the Budget reflects an expected decrease in the number 
of women who will be eligible for these cancer screening services due 
to expanded insurance coverage under the Affordable Care Act. To 
maximize the impact of the new coverage expansions, the Budget 
continues the fiscal year 2015 policy to allow, but not require, all 
States to shift their funds from direct services to population-level 
interventions (such as outreach and education activities). CDC expects 
State support of population-level interventions will help improve 
access to cancer screenings available through the Affordable Care Act 
and CDC's cancer screening programs.

                          SUBCOMMITTEE RECESS

    Senator Blunt. The subcommittee stands in recess until 10 
a.m. Thursday, April 30.
    Thank you, Secretary.
    [Whereupon, at 11:57 a.m., Thursday, April 23, the 
subcommittee was recessed, to reconvene at 10 a.m., Thursday, 
April 30.]
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