[Senate Hearing 114-680]
[From the U.S. Government Publishing Office]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2017
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THURSDAY, MARCH 3, 2016
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee me at 9:59 a.m., in room SD-138, Dirksen
Senate Office Building, Hon. Roy Blunt (chairman) presiding.
Present: Senators Blunt, Moran, Cochran, Alexander,
Cassidy, Capito, Lankford, Murray, Durbin, Mikulski, Shaheen,
Merkley, and Schatz.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
STATEMENT OF SYLVIA M. BURWELL, SECRETARY
opening statement of senator roy blunt
Senator Blunt. Good morning. Thank you, Secretary Burwell,
for appearing before the subcommittee today to discuss the
Department of Health and Human Services' fiscal year 2017
budget request. We look forward to hearing your testimony.
We have many shared priorities in this budget proposal--
cancer research, combating opioid abuse, increasing access to
mental healthcare. I was disappointed, however, that many of
these investments are not part of the discretionary budget
request, something that we want to talk about today, that I at
least want to talk about today. This is a precarious position I
think for the department to be in.
The request leans heavily on new mandatory spending
proposals that bypass the current budget caps and bypass the
discretionary allocations in the committee. If the committee
would follow the recommendation from the department, we would
cut almost $2 billion for programs currently funded by
discretionary spending in this bill and I guess you would
expect, and the administration would expect, new currently
unauthorized mandatory funding to fill those holes. It is one
thing if that happens, another significant thing if it does
not.
My view would be that we need to figure out how to
prioritize, that everything cannot be a priority, so this
should be a discussion between us on the committee and with you
as to where we need to allocate the money we have to spend in
your department. It seems to me the department submission just
assumes that we will solve this problem by mandatory spending
and new resources that I have no particular reason to believe
the Congress is likely to agree with.
The subcommittee needs to look at what you have suggested,
look at the cuts that would happen if we just simply would
adopt your budget. For instance, with discretionary spending,
we would eliminate children's hospital medical education
dollars. That would theoretically come from somewhere else, but
if we assume that is going to happen, there would be no
graduate medical education in children's hospitals.
The administration's proposed funding increases can only be
achieved by mandatory increases. My overarching concern is that
whether the department would truly be prepared for the budget
you submitted if those mandatory programs do not happen.
I think it is something we should all be very thoughtful
about, because once we get through this process and those do
not occur, that would mean a $1 billion cut in the National
Institutes of Health. It would mean, as I just suggested, no
money for graduate medical education at children's hospitals.
So I do not agree with the approach, but maybe you can
assure us on how that approach is going to have more success
than I think it is likely to have.
But I do want to complete my opening remarks by saying I
think you bring great capacity to this job. I appreciate your
openness to discuss these and other issues, not only here today
but you have really been extraordinary in reaching out to talk
about the challenges that the department faces. And I look
forward to continuing that discussion.
I am pleased now to recognize Senator Murray for her
opening comments.
statement of senator patty murray
Senator Murray. Thank you very much, Mr. Chairman.
Secretary Burwell, thank you for being here today and for
all that you do every day to improve the health and well-being
of our families and communities across the country.
I look forward to your testimony today and the discussion
about the department's funding needs for the fiscal year 2017.
While I know you are going to be highlighting the department's
request in your statement, I do want to note how pleased I was
to see that it proposes a significant increase for early
learning and child care. That includes $161 million to
implement the safety and quality improvements that were
contained in the reauthorization of the Child Care and
Development Block Grant, which the Senate approved 16 months
ago with overwhelming bipartisan support, 88-1, due in no small
part to the leadership of Vice Chairwoman Mikulski.
And I thank you as well for that.
Those investments really support working families and help
make sure our kids start kindergarten ready to learn.
I was also pleased the budget maintains support for the
Affordable Care Act, which has expanded health insurance
coverage to millions of people and helped a lot more families
pay less for better quality care. We need to keep working
toward more coverage, not less; more affordability, not less;
and better quality, not less. That is something I know that, on
this side, Democrats will continue to be focused on.
Overall, there is much to like in the President's HHS
budget request. It builds on the bipartisan spending bill that
Congress passed late last year, a bill that was possible
because Democrats and Republicans were able to come together
and break through the gridlock and reach a budget agreement
that allowed us to provide needed discretionary investments in
NIH, CDC, worker training, child care, early learning programs,
just to name a few.
That agreement showed that, once again, when we work
together to find common ground, we can deliver results to the
families and communities we serve. I am hopeful that we can
build on last year's momentum to do the same again this year.
Many of the challenges facing us remain the same as when
Secretary Burwell testified before the subcommittee last
spring. There is still much more we need to do to continue work
started in the Affordable Care Act to expand access to quality,
affordable healthcare.
The intense competition for NIH grants means that fewer
than 20 percent of applications get funded, leaving lots of
promising science without support.
And the epidemic of opioid and prescription drug abuse
continues to hurt families and communities nationwide.
Secretary Burwell, as you well know, our broken mental
healthcare system is yet another ongoing challenge we have to
tackle. I know this is a priority that many members here today
as well as on the HELP Committee share, and it is a focus for
the administration as well.
So I am very hopeful that the bipartisan momentum we are
seeing on this can continue, and that we can work together on
some solutions that expand access to quality, effective mental
healthcare so many families are struggling to find.
We will be challenged to find ways to address these and
other persistent needs while also taking into account the new
policies laid out in the Every Student Succeeds Act that
Senator Alexander and I helped write and signed into law in
December.
As everyone here knows, the 2-year budget agreement rolled
back the automatic cuts and allowed us to restore key
investments, but it did not go as far as many of us had hoped.
That means, as it often does, difficult choices will be
unavoidable in 2017, as they were last year. Even so, I believe
that our subcommittee can find a way to write a bipartisan bill
once again. But doing so depends on this subcommittee getting
an allocation that will allow us to make the needed investments
in education and medical research and drug treatment and
support for working families and a lot more. I know Chairman
Blunt would like to work on this bill in a bipartisan manner as
well, and build on the progress that we have made.
So I look forward to working with you, Secretary Burwell,
and all of our colleagues who are here today, in the coming
weeks and months. Thank you very much.
Senator Blunt. Thank you, Senator Murray. We do hope to be
able to work on this bill together.
Secretary Burwell, again, we are delighted you are here. We
look forward to your testimony.
summary statement of hon. sylvia m. burwell
Secretary Burwell. Thank you. Chairman Blunt, Chairman
Cochran, and Ranking Member Murray, and Ms. Mikulski as well,
and all the members of the committee, I want to thank you for
this opportunity to discuss the President's Department of
Health and Human Services budget for this year.
As many of you all know, I believe that all of us share
common interests and that we can find common ground. In the
last legislative session, this Congress made timely investments
in programs to improve the health and welfare of the American
people, and I thank you all and this committee for that.
The budget before you today is the final budget for this
administration, and my final budget. It makes critical
investments to protect the health and well-being of the
American people. It helps ensure that we do our job to keep
people safe and healthy, accelerates the progress in scientific
research and medical innovation, and expands and strengthens
our healthcare system. And it helps us continue to be
responsible stewards of the taxpayer dollars.
For HHS, the budget proposes $82.8 billion in discretionary
budget authority. Our request recognizes the constraints in our
budget environment, and includes targeted reforms to Medicare,
Medicaid, and other programs.
Over the 10 years, these reforms to Medicare would result
in savings of $419 billion.
In order for Americans to benefit from recent breakthroughs
in medical science, we need to ensure that all Americans have
access to quality, affordable healthcare.
The Affordable Care Act has helped make historic progress.
Today, more the 90 percent of Americans have health coverage,
the first time in our Nation's history that this has been true.
This budget seeks to build on that progress by improving both
the quality of the care that patients receive, spending our
healthcare dollars more wisely, and putting engaged and
empowered individuals at the center of their care.
It proposes investments to improve the access to care for
underserved groups across the United States, including many
living in rural communities. With $5.1 billion in health center
funding and nearly $14 billion over the next decade proposed
for our Nation's healthcare work force, even more Americans
will be able to get the care they need.
By advancing and improving the way we pay doctors,
coordinate care, and use health data and information, we are
building a better, smarter healthcare system.
Let me turn to an issue we have been working on here at
home and abroad. As we work aggressively to combat the spread
of Zika, the administration is requesting $1.9 billion in
emergency funding, including $1.5 billion for the Department of
Health and Human Services.
We appreciate Congress' consideration of this important
request as we implement the essential strategies to prevent,
detect, and respond to this disease.
I know the rise in opioid misuse and abuse and overdose has
affected many of your constituents. Every day in America, 78
people die from opioid deaths. That is why this budget proposes
significant funding, over $1 billion, to combat the opioid
epidemic.
Research shows that early learning programs can set a
course for a child's success throughout his or her life, and
that is why over the course of this administration and together
with congressional support, we have more than doubled access to
Early Head Start and services for infants and toddlers. Our
budget proposes a total of $9.6 billion for the Head Start
program and an investment in child care services that would
allow us to serve over 2.6 million children.
Today, too many of our Nation's children and adults with
diagnosable mental health disorders do not receive the
treatment that they need. So this budget proposes $780 million
in new mandatory and discretionary resources over the next 2
years.
While we invest in the safety and health of Americans
today, we must also relentlessly push forward the frontiers of
science and medicine. This budget invests in the Vice
President's cancer initiative. Today, we are entering a new era
in medical science, and with the proposed increase of $107
million in the Precision Medicine Initiative, and $45 million
for the administration's BRAIN Initiative, we can continue that
progress.
Finally, I just want to thank the employees of HHS. In the
past year, they have helped with the Ebola outbreak in West
Africa; they have helped millions of Americans enroll in health
coverage; and they have done the quiet day-to-day work that
makes our Nation healthier and stronger. And I am honored to be
a part of their team.
As members of this committee know, I am personally
committed to working closely with you and your staff to find
common ground and deliver impact for the American people.
With that, I welcome your questions.
[The statement follows:]
Prepared Statement of Hon. Sylvia M. Burwell
Chairman Blunt, Ranking Member Murray, and Members of the
Committee, thank you for the opportunity to discuss the President's
fiscal year 2017 Budget for the Department of Health and Human Services
(HHS). In fiscal year 2016, the Congress made timely investments in
programs to improve the health and welfare of American citizens, such
as programs to address opioids abuse and expanding access to healthcare
centers and Head Start. The fiscal year 2016 appropriation also made
important investments in many research frontiers like precision
medicine and research to combat antibiotic resistant bacteria. We thank
you for your leadership on these important issues and look forward to
building on these investments in fiscal year 2017.
The Department has made historic strides towards ensuring that all
Americans have access to the building blocks of healthy and productive
lives--a priority that I know we share. Thanks to the Affordable Care
Act, we have helped millions of Americans find quality, affordable
insurance, and slowed the growth in healthcare costs for families and
taxpayers. At the same time, we have worked to improve the quality of
coverage--with more protections and benefits, like wellness visits and
some cancer screenings now offered at no extra cost--no matter where
you get your insurance. Alongside this work, we have responded to a
number of national and global health challenges. In coordination with
our partners across the Federal Government, we led a response to the
Ebola outbreak in West Africa and prepared our infrastructure here at
home, and have helped to unite global health leaders to prevent and
respond to future outbreaks. We convened state leaders in our fight
against prescription opioid misuse and overdose as part of a nationwide
three-pronged strategy to drive progress. And we advanced the frontier
of medicine through cutting-edge research in genomics and technology.
Through all these efforts, we have worked to ensure the responsible
stewardship of taxpayer dollars by taking steps to further strengthen
program integrity, saving money for the taxpayer and making sure our
programs deliver in the best possible way for those we serve.
The President's fiscal year 2017 Budget for HHS builds on this
progress through critical investments in healthcare, science and
innovation, and human services. The Budget proposes $82.8 billion in
discretionary budget authority, and additional mandatory funding to
further support specific initiatives in the discretionary budget. This
includes investments in critical priorities that I know we share--
cancer research, opioids abuse prevention and treatment, healthcare
access, and behavioral health efforts. The Budget recognizes our
continued commitment to balancing priorities within a constrained
budget environment through legislative proposals that, taken together,
would save on net an estimated $242 billion over 10 years.
building upon the successes of the affordable care act
The fiscal year 2017 Budget advances access, affordability, and
quality in our Nation's healthcare system--goals that we share with
Congress and this Committee. Through targeted investments, the Budget
expands access to care, particularly for rural and other underserved
populations, and supports primary and preventive care.
Investing in Health Centers.--For 50 years, health centers have
delivered comprehensive, high-quality, cost-effective primary
healthcare to patients regardless of their ability to pay. Today, more
than 1,300 health centers operate over 9,000 sites and provide
healthcare services to 1 in 14 people in the United States, including
to approximately 454,000 patients at 217 service delivery sites in
Missouri and 910,000 patients at 298 service delivery sites in
Washington. Health centers also play a role in reducing the use of
costlier care through emergency departments and hospitals. The Budget
invests $5.1 billion in health centers, including $3.75 billion in
mandatory resources, to serve approximately 27 million patients across
the country in fiscal year 2017.
Increasing Access to Health Care for Minority and Underserved
Populations.--The Department is investing in several initiatives that
will improve access to care for underserved groups across the United
States, including those living in rural areas. We know that this is a
priority for many of you on this Committee. The Budget includes
investments of nearly $14 billion over 10 years in our Nation's
healthcare workforce to improve access to healthcare services,
particularly in rural and other underserved communities. This includes
support for over 10,150 National Health Service Corps clinicians
serving the primary care, mental health and dental needs of more than
10.7 million patients in areas with limited access to care. The request
includes additional funding to place providers in rural areas and other
underserved communities in order to expand access to treatment for
prescription opioid and heroin abuse and to improve access to crucial
mental and behavioral health services. In addition, the Budget will
allow the Health Centers Program to serve an estimated 9.7 million
rural Americans, an increase of approximately 1.5 million more rural
patients than are served today.
The Department also takes steps to close health disparities for
minorities and Native Americans. The fiscal year 2017 Budget provides
an estimated $13 billion, a $382 million increase above fiscal year
2016, for programs and services to improve the health of minority
communities and reduce health disparities. In addition to the
investments in the Health Centers Program, where over 60 percent of
patients are from racial or ethnic minorities, the Budget also extends
$14 million in funding for the Health Career Opportunities Program to
increase the diversity and cultural competence of the health
professions workforce.
The fiscal year 2017 Budget more than doubles available funding
across the Department to help close the gap in behavioral health
disparities experienced by American Indians and Alaska Natives through
preventive and crisis response, an increase of $87 million above fiscal
year 2016 for a total of $141 million. This funding would support
targeted efforts within the Indian Health Service (IHS), Substance
Abuse and Mental Health Services Administration (SAMHSA) and Centers
for Disease Control and Prevention (CDC) to reduce rates of substance
abuse, improve access to mental health services, and prevent suicide.
The Budget also increases funding for the IHS by $402 million to
continue progress and reduce health disparities in Indian Country, as
well as fully funding contract support costs, which provides critical
overhead funding to tribes who operate facilities under self-
determination and self-governance agreements. The Budget removes the
cap on funding to Medicaid programs in the U.S. territories to better
align territory Medicaid programs with those of States and expands
eligibility to 100 percent of the Federal poverty level in territories
currently below this level. This proposal would gradually increase the
share of Medicaid costs covered by the Federal Government as
territories modernize their Medicaid programs--providing critical
healthcare funding to Puerto Rico and helping to mitigate the effects
of its fiscal crisis.
Expanding Access to Health Insurance Coverage. The Affordable Care
Act is expanding access to care for millions of Americans who would
otherwise be uninsured, improving quality of care for people no matter
how they get their insurance, while slowing the growth in healthcare
costs nationwide. To encourage more States to expand Medicaid, the
Budget would give any State that chooses to expand Medicaid eligibility
3 years of full Federal support, no matter when the State expands. The
Budget also funds the Children's Health Insurance Program through
fiscal year 2019 to ensure comprehensive and affordable coverage for
beneficiaries as well as budget stability for States.
healthcare delivery system reform
At HHS, we are focused on moving towards a healthcare system that
delivers better quality of care, spends dollars in a smarter way, and
keeps people healthy. The Budget advances the Department's work in
three critical areas: improving the way providers are paid, finding
better ways to deliver care, and creating better access to healthcare
information for providers and patients.
Improving the Way Providers Are Paid.--Rather than paying for the
quantity of tests and screenings that providers order--a common
practice--the Department is moving toward paying for the quality of
care given. For patients, this can lead to more frequent communication
with their care provider and fewer unnecessary trips back to the
hospital. The Budget includes proposals to establish competitive
bidding for Medicare Advantage payments and introduce value-based
purchasing for certain Medicare providers. The Budget also encourages
participation in alternative payment models through a number of
proposals, including creating a bonus payment for hospitals that
collaborate with certain alternative payment models. The Department has
already committed to moving Medicare fee-for-service payments to 30
percent in alternative payment models by the end of 2016, and 50
percent by 2018. We believe that we are on track to meet our goal, and
look forward to working with Congress to build on this progress.
Improving Care Delivery.--To drive progress in the way care is
provided, HHS is focused on improving the coordination and integration
of healthcare, engaging patients more fully in decisionmaking, and
improving the health of patients--with an emphasis on prevention and
wellness. As part of that, we are focused on improving access to care
by investing in and supporting telehealth, especially for rural areas.
The Budget proposes to expand the ability of Medicare Advantage plans
to deliver services via telehealth, and to enable rural health clinics
and federally qualified health centers to qualify as originating
telehealth sites under Medicare. By integrating face-to-face care with
remote access care in both rural and urban areas, this proposal could
improve care coordination, provide for more timely exchanges between
specialists, and facilitate beneficiary access to care.
Improving Access to Information.--In an effort to promote
transparency on price, cost, and billing for consumers, the Budget
supports the standardization of billing documents and elimination of
surprise out-of-network charges for privately insured patients
receiving care at an in-network facility. The Budget also provides
continued investments to achieve secure, seamless data interoperability
in order to better serve individuals, providers, and payers, including
a funding increase and new authorities for the Office of the National
Coordinator for Health Information Technology.
Building Evidence to Drive Systemic Improvement.--Reforming the
delivery system requires an evidence base of effective practices. The
Budget proposes an increase of $24 million for health services research
at the Agency for Healthcare Research and Quality (AHRQ) to advance and
improve the performance of the healthcare system. For example, AHRQ
data show that 87,000 fewer patients died in hospitals due to hospital-
acquired infections and conditions from 2010 to 2014--saving nearly $20
billion. While we are encouraged by this progress, substantial
challenges remain to build a health system that meaningfully involves
patients in decisionmaking, and consistently uses high quality evidence
to provide safe and high quality care for all.
keeping people healthy and safe
The President's Budget builds on the Department's strategy to
address prescription drug abuse, invests in crucial behavioral health
services, and strengthens our Nation's public health infrastructure.
Preventing Prescription Opioid Misuse and Overdose.--Prescription
drug abuse impacts the lives of millions of people across the country--
with 78 Americans dying in opioid-related deaths every single day. The
Budget proposes significant new discretionary and mandatory funding
totaling nearly $1.1 billion to build on investments funded by Congress
in fiscal year 2016 and to execute on the Department's three-pronged
evidence-based approach to combat the opioids crisis:
--Expanding the Use of Medication-Assisted Treatment.--The new two-
year, $1 billion mandatory funding investment will help ensure
that every American who wants to get treatment for an opioid
addiction will be able to. These funding levels will enable
individuals with opioid use disorder to get treatment in fiscal
year 2017 and fiscal year 2018 by reducing costs, engaging
patients, and expanding access to treatment.
--Improving Prescribing Practices.--The Budget invests in programs
that support improved prescribing practices, including by
supporting improved uptake of CDC's upcoming opioid prescribing
guidelines for providers. The Budget also proposes to require
States to track high prescribers and utilizers of prescription
drugs in Medicaid--saving $770 million over 10 years--and
bolsters other critical efforts to support providers with the
tools they need.
--Expanding the Development and Use of Naloxone.--Responders to an
overdose have little time to effectively reverse the effects of
an opioid and save a life. To best prepare communities and
first responders, the Budget includes a total of $22 million
for programs that support the use of naloxone--a lifesaving
overdose reversal drug. Among other critical programs, the
Budget invests $10 million in the Rural Opioid Overdose
Reversal Grant program to target rural areas hit hardest by
opioid abuse.
Expanding Access to Mental and Other Behavioral Health Care.--
Despite the expanded behavioral health coverage for millions of
Americans by the Affordable Care Act, less than half of children and
adults with diagnosable mental health disorders receive the treatment
they need. To address this gap, the Budget proposes a total of $999
million, including a new 2-year $500 million investment in mental
healthcare, to help engage individuals with serious mental illness in
care, improve access to care by increasing service capacity through
certified community behavioral health clinics, boost the behavioral
health workforce, and ensure that behavioral healthcare systems work
for everyone. A portion of the 2-year, $500 million mandatory
initiative will allow six additional States to participate in the
Certified Community Behavioral Health Clinic Demonstration--established
by section 223 of the Protecting Access to Medicare Act of 2014.
Combating Antibiotics Resistant Bacteria.--The emergence of
antibiotic-resistant bacteria continues to be a significant public
health concern. The fiscal year 2017 Budget includes $877 million to
continue expanding the Nation's ability to protect patients and
communities by implementing interventions that reduce the emergence and
spread of antibiotic-resistant pathogens. This funding will also
support ongoing ground-breaking research to aid the development of new
drugs and diagnostic products, building the Nation's treatment options
for these dangerous pathogens.
Investing in Domestic and International Preparedness.--The
Department leads critical efforts to strengthen our public health
infrastructure here at home and bolster the Nation's preparedness
against chemical, biological, nuclear and radiological attacks. The
Budget invests $915 million, an increase of $2 million, for domestic
and international public health infrastructure, including funding to
expand implementation of the Global Health Security Agenda (GHSA) to
strengthen capacity in Phase 2 countries to address public health
emergencies. Over the next 5 years, the United States will work with
more than 30 partner countries--representing over four billion people--
to help them prevent, detect, and effectively respond to infectious
disease threats. I am pleased to share that work with many of these
countries has already begun. We appreciate the funding provided by
Congress last year for this crucial priority.
As we work aggressively to combat the spread of Zika, the
Administration is requesting $1.9 billion in emergency funding,
including $1.5 billion for HHS, to enhance our ongoing efforts both
domestically and internationally. The requested resources will build on
our ongoing preparedness efforts and will support essential strategies
to combat this virus, such as rapidly expanding mosquito control
programs; accelerating vaccine research and diagnostic development;
enabling the testing and procurement of vaccines and diagnostics;
educating healthcare providers, pregnant women and their partners;
improving epidemiology and expanding laboratory and diagnostic testing
capacity; improving health services and supports for low-income
pregnant women, and enhancing the ability of Zika-affected areas to
better combat mosquitoes and control transmission. We appreciate the
Congress's consideration of this important request.
Serving Refugees and Unaccompanied Children.--In light of a global
displacement crisis, the Administration has committed to expanding the
Refugee Admissions Program in fiscal year 2016 and fiscal year 2017.
All refugees are subject to the highest level of security checks of any
category of traveler to the United States. At HHS, the Administration
for Children and Families' role is to link newly-arrived humanitarian
populations, including refugees, asylees, Cuban entrants, and special
immigrant visa-holders, to key resources necessary to becoming self-
sufficient, integrated members of American society. The Budget provides
initial financial and medical assistance for an estimated 213,000
entrants, including 100,000 refugees, consistent with the
Administration's commitment to admitting at least 100,000 refugees in
fiscal year 2017.
In addition to serving the populations discussed above, HHS is also
legally required to provide care and custody to all unaccompanied
children apprehended by immigration authorities until they are released
to appropriate sponsors to care for them while their immigration cases
are processed. Based upon the increase in unaccompanied children
apprehended at the Southwest border this fall, ACF has taken prudent
steps to identify temporary capacity so that we are adequately prepared
if additional shelter space is needed. To ensure that HHS can provide
appropriate care for unaccompanied children in fiscal year 2017, the
Budget includes the same amount of total base resources available in
fiscal year 2016, as well as a contingency fund that would trigger
additional resources only if the caseload exceeds levels that could be
supported with available funding.
building blocks for success at every stage of life
The Budget request supports the Department's efforts to serve
Americans at every stage of life, including by promoting the safety and
well-being of our Nation's children, and helping older Americans live
as independently as possible.
Investing in Child Care and Early Learning.--Research has shown the
significant positive impact that early learning programs can have on a
child's development and lifelong well-being. The Budget proposes
strategic investments to make affordable, quality child care available
to every low- and moderate-income family with young children; to build
on investments to expand access to high quality early learning programs
including both Head Start and the newly authorized Preschool
Development Grant program; and to invest in voluntary, evidence-based
home visiting programs that have long-lasting, positive impacts on
child development.
With congressional support, the Administration's investment in Head
Start services has more than doubled access for infants and toddlers
over the course of the Administration, and significant investments have
been made to strengthen the quality of services that Head Start
provides. The fiscal year 2017 Budget provides a total of $9.6 billion
for the Head Start program, which includes the resources necessary to
maintain this expansion of services. In addition, the Budget builds on
the investments made in fiscal year 2016 to expand the number of
children attending Head Start programs that offer a full school day and
year program, which is proven to be more effective than programs of
shorter duration and helps meet the needs of working parents. In
collaboration with the Department of Education, the Budget includes
$350 million for Preschool Development Grants to support States in
building and expanding high-quality preschool systems.
The President's Budget continues the historic proposal to provide
$82 billion over 10 years in additional mandatory funds for child care
to ensure that all low- and moderate-income working families with young
children have access to high-quality child care. This proposal will
increase the number of children served to a total of 2.6 million by
2026 and raise the quality of care children receive. In addition, the
fiscal year 2017 Budget includes almost $3.0 billion in discretionary
child care funding, an increase of about $200 million, to support
States, tribes, and territories as they implement the new health,
safety, and quality requirements of the bipartisan child care
reauthorization, and to create pilots that will test and evaluate
strategies for addressing the child care needs of working families in
rural areas and families working non-traditional hours.
Supporting Child Welfare.--The Department plays a critical role in
supporting child welfare, particularly among vulnerable populations.
The Budget includes $1.8 billion over 10 years to ensure that child
welfare professionals have the right training and skills--proven to be
linked to better outcomes for children across a range of measures. The
Budget also includes a package of investments designed to do more to
prevent the need for foster care and assist children and families so
that children can either be reunited with their biological parents or
placed in a permanent home.
Supporting Older Adults.--As members of this Committee are aware,
the population age 65 and over is projected to more than double to 98
million in 2060. In fiscal year 2017, HHS continues to make investments
to address the needs of older Americans, many of whom require some
level of assistance to live independently and remain in their homes and
communities for as long as possible. The Budget continues to propose
reforms that help to protect older Americans from identity theft, to
support access to counseling, respite, and nutrition services that will
allow States to provide approximately 205 million meals to over 2
million older Americans nationwide. The Budget also continues the
Department's commitment to support effective Alzheimer's disease
research, education, and outreach, as well as patient, family, and
caregiver services.
leading the world in science and innovation
The fiscal year 2017 Budget builds on the historic gains the
Department has made in medical and scientific research and lays the
ground work for scientific and technological breakthroughs for the 21st
century. Thanks to biomedical research, including NIH investments,
cardiovascular death rates in the United States have fallen by more
than 70 percent in the last 60 years. Cancer death rates are now
falling 1-2 percent per year; each 1 percent drop saves approximately
$500 billion. Breakthroughs in HIV therapies enable people in their
20's to live a full life span. The fiscal year 2017 Budget includes
$33.1 billion for the NIH, an increase of $825 million, to build on the
funding provided by this Congress in order to advance our shared
commitment to support research that promotes economic growth and job
creation, and advances public health.
Launching the Cancer Moonshot.--Investments in research have led to
significant developments in the prevention, screening, and treatment of
cancer. To support the Vice President's Cancer Moonshot, the Budget
includes a multi-year $755 million initiative that accelerates the
Nation's fight against cancer by expanding access to clinical trials,
pursuing new vaccine technology, and funding exceptional opportunities
in cancer research. These investments will drive scientific advances
that aim to understand the causes of cancer, discover new prevention
strategies, improve early detection and diagnosis, and develop
effective treatments.
Advancing Precision Medicine.--Recent breakthroughs in genomics,
computing, and molecular medicine have ushered in a new era where more
treatments are based on the genetic characteristics of each patient.
The Budget increases funding for the Precision Medicine Initiative by
$107 million to a total of $309 million to support critical new studies
on therapies, and to continue to scale a cohort study to gather data on
the interplay of environmental exposures, physical parameters, and
genetic information.
Investing in the BRAIN Initiative.--Despite the advances in
neuroscience in recent years, the underlying causes of most
neurological and psychiatric conditions remain largely unknown due to
the vast complexity of the human brain. To further revolutionize our
understanding, the Budget provides an increase of $45 million, for a
total of $195 million within NIH, for the BRAIN Initiative. This
research has the potential to discover underlying pathologies in a vast
array of brain disorders and provide new avenues to treat, cure, and
even prevent common conditions, such as Alzheimer's disease, autism,
depression, schizophrenia, and addiction.
making the department stronger
One of my top priorities as Secretary is to position the Department
to most effectively fulfill its core mission by investing in key
management priorities, including program integrity and cybersecurity. I
appreciate the Committee's interest in these critical issues.
Strengthening Program Integrity.--The Budget continues to make
cutting fraud, waste, and abuse a top Administration priority by
requesting $199 million in new program integrity investments in fiscal
year 2017. The Budget fully funds the Health Care Fraud and Abuse
Control (HCFAC) discretionary cap adjustment. In fiscal year 2015 alone
the HCFAC program returned over $2.3 billion to the Federal Government
and private citizens. The Budget includes proposals that will expand
and strengthen the tools available to CMS and States to combat fraud,
waste, and abuse, including in State Medicaid programs. In total,
proposed program integrity investments and authorities in the Budget
will yield an estimated $25.7 billion in scorable and non-scorable
savings to Medicare and Medicaid over 10 years.
Focusing on Stewardship.--To improve the efficiency of the Medicare
appeals system and reduce the backlog of appeals awaiting adjudication
at the Office of Medicare Hearings and Appeals (OMHA), HHS has
developed a comprehensive strategy that involves additional funding,
administrative actions, and legislative proposals. The Budget includes
resources at all levels of appeal to increase adjudication capacity and
advances new strategies to alleviate the current backlog. The Budget
also includes a package of legislative proposals that provide new
authority and additional funding to address the backlog.
conclusion
Members of the Committee, thank you for the opportunity to testify
today and for your continued leadership on these important issues. I am
grateful to have you as partners as we make the investments critical
for today while laying a stronger foundation for tomorrow. I want to
conclude by thanking the men and women of our Department, who work
tirelessly every day to deliver impact for those we serve--the American
people. I welcome your questions.
Senator Blunt. Thank you, Madame Secretary, for your
comments.
We will have time for a second round of questions, so with
the exception of Chairman Cochran and Senator Mikulski, I am
going to run a pretty tight clock here. They can, by the way,
talk as long as they want to. But we will then have time for a
second round. So hopefully we will all think about everybody
else's time, and I will try to limit my own time in exactly the
same way.
SUPPLANTING DISCRETIONARY FUNDING
What about the question I suggested in my opening
statement, Secretary Burwell? What if you get the budget you
asked for and the mandatory funding that you hope happen do not
happen? What would you have to come back and ask us to do that
would not be happening, if you got your budget and the
mandatory supplements do not occur?
Secretary Burwell. So as we put the budget together, we put
it together as a budget. We put it together in terms of what we
think are the right needs and the right trade-offs. I think it
is important to reflect the mandatories that we proposed are
paid for.
When we look at the issue of discretionary funding, as we
think about----
Senator Blunt. They are paid for out of noncurrent sources
of revenue, right?
Secretary Burwell. I think we proposed the revenue choices
and other choices in terms of cuts. As I said, there is $419
billion in Medicare savings that we have, and there are a bunch
of other things that we put in our budget to do the appropriate
savings.
When we put forth a budget, it is about choices. And within
our budget, we made the choices that we think we should make. I
think it relates to the issue of the overall level of
discretionary funding. That is something that I think, in the
world that we live in--where we have issues like opioids,
behavioral health, the research that we all want to do--that
when we think that we are going to end up in a place where our
discretionary spending as a percentage of GDP (Gross Domestic
Product) is at some of the lowest levels we have ever seen as a
Nation, is that where we want to be?
So we wanted to make sure that we are abiding by the deal
but also reflecting what we believe are the right choices in
terms of that spending.
Senator Blunt. The mandatory funding is paid for out of tax
increases that the Congress would have to approve. Is that
right?
Secretary Burwell. There are a combination of things
throughout our budget. Some of those are revenue issues, but
other things are on the other side in terms of some of the
Medicare savings. In addition, there are other things in our
budget alone--and some may bring this up--we have actually cut
spending on a number of things in terms of programs. And it is
not a popular cut we do, but we have cut funding in terms of
the CDC and vaccines that we believe are now being taken care
of through the Affordable Care Act, because people have that
coverage, and that there is lower demand on those programs.
So we put together a combination of things to pay for those
investments that we believe are necessary for the country's
health.
OPIOID EPIDEMIC
Senator Blunt. On opioids, we increased spending last year
by almost 300 percent. I think we got slightly above the number
that you asked for. I think we went from about $31 million or
$32 million to $123 million, which was a big increase. I think
your proposal here is $1 billion more over 2 years?
Secretary Burwell. Yes. It would take us to $1.2 billion. I
think in the area of opioids, it is related to an issue that I
know you have been an incredible champion on, which is
behavioral health. We all know that one of the issues around
behavioral health is that it is actually paid for at the State
and local level.
In terms of the capacity, one of the things that is most
important in a strategic approach for opioids is medication-
assisted treatment. That needs to occur on the ground in the
communities in States like our home State of West Virginia, and
all across the Nation.
So the idea that we are going to be able to provide the
capacity for treatment for the numbers of people we have is why
we have proposed the increase.
The vast majority of the increase that we proposed in
opioids is for medication-assisted treatment that will go to
the States and local communities.
Senator Blunt. Just to help us make that case a little
better, as we discuss it, what is your view of what has
happened. This is a problem that we were allocating $31 million
to 18 months ago and one that we would now be looking at
something in the neighborhood of a half billion dollars a year?
Secretary Burwell. I think it is the demand and the need.
When 78 Americans are dying every day, I think we are at a
point where it is a crisis in our Nation. I think you know,
when I got to the Department, I asked for an evidence-based
strategy to build on the work that we had been doing with very
specific areas of focus that could have measurable results with
regard to the reduction in the number of addictions and
reduction in the number of overdoses and a reduction in the
number of opioid deaths.
That strategy had three parts to it, and one of the parts
is costly, but I think the more conversations we have--I know
you all are having them with law enforcement officials, that
they have become the healthcare and social services system. So
we have to have a place for those folks to go, and we have so
many of them now that the needs are great.
Senator Blunt. Senator Murray.
Senator Murray. Mr. Chairman, I know that the vice
chairwoman has to leave to go chair another committee, so I am
happy to switch spots with her and let her go first.
Senator Mikulski. Thank you, Senator Murray.
There is a lot going on today. In addition to the Labor-HHS
hearing with this fantastic attendance, CJS will be meeting in
30 minutes, and MilCon-V.A. is also meeting.
So I want to thank Senator Cochran for really mandating
such a quick-paced schedule that we have our hearings and do
our job and look forward to, again, working with both he and
Senator McConnell to follow the budget agreement, get our
302(b)s and get going. So thank you very much for your
leadership.
Secretary Burwell, we do want to thank you for your
leadership and the way you have run the department. I think you
brought stability to the work force, confidence in the
Congress. Your responsiveness to us I think is very much
appreciated.
As we look at President Obama's last budget, we know what
your agency does, with its 73,000 people, touches every aspect
of American lives. We need to be able to do what we need to do
to really be able to help American lives.
I have to my right a champion of NIH, as so many of us are
here, the chairman, the vice chairman of this committee. We
have to recognize that the defense of the needs of our country
are not only in the Defense Department, and this is why we need
to look at domestic discretionary spending and maintain parity
with those two.
We are going to get to my questions. Senator Murray and I
conferred. She will be asking a lot of the questions that I
have in mind, like the opioid issue, the early childhood issue,
and so on.
ZIKA SUPPLEMENTAL
Let me get to the Zika supplemental. The chairman raised
the issue of his concern about mandatory funding. I am
concerned about that, too, and what could get cut. But you
know, we just had a robust debate yesterday on a supplemental
on opioids offered by Senator Shaheen. You have here before us
the Zika supplemental. I am concerned that we just do not have
enough to meet the emerging needs of our country.
And with the Zika supplemental, one, is it a big threat?
And number two, why can't we use the money that has been left
over from Ebola? And number three, is it that we really need to
look at CDC in the same way we have to look at our preparedness
for a bio-attack, a chemical weapons attack, and so on?
We have to come to grips with the Zika supplemental. I
talked to Dr. Frieden, Dr. Fauci.
Dr. Fauci, we are turning to him once again. We are
grateful to have him at NIH. But he is grateful to have our
help.
So could you comment on the Zika supplemental? Is this the
way we are going to do government, mandatory spending,
supplementals? Or do we need an appropriations that America can
count on and its Secretary can count on?
Secretary Burwell. With regard to that broader question of
where caps should be for discretionary funding, I could wear my
old hat at OMB and we could discuss. And I certainly have
opinions, but I will address directly this Zika question.
On the issue of Zika, every day I get a report, and we have
more and more people. We have now in the United States more
cases confirmed of sexual transmission. When we think about
Zika, and thinking about it at your level, I think there are
three very important things to focus on. I think right now our
most important focus is on making sure that fewer pregnant
women get Zika and have the consequences of babies with very
serious birth defects, microcephaly.
So, one, we need to protect those pregnant women.
Number two, there are many knowns and unknowns. Right now,
as I am sure Dr. Frieden and Dr. Fauci have shared with you, we
do not know the answers as to how quickly this spreads, in
terms of whether or not it stays in semen for an extended
period of time, or how long that is. So right now, we have to
give guidance telling pregnant women to be extremely careful.
We do not know what point in a woman's pregnancy that it
has impact. There are many unknowns.
The money we are asking for is to make sure we can do the
research and prepare the homeland. Right now, Puerto Rico has
cases that are transmitted in Puerto Rico, not travel-related
cases.
So with regard to the issue of Zika, the money and the
needs are urgent as we prepare our Southern States especially
for the summer for a mosquito that can breed in a capful of
water, that is indoors, and can bite four people in one meal.
So we are working very hard and have a plan to do that. The
funding needs to come and is time-sensitive.
EBOLA
Senator Mikulski. Why can't you use the money that is left
over from Ebola? That has been my position.
Secretary Burwell. With regard to the issue of the Ebola
money----
Senator Mikulski. In other words, why do we need a
supplemental?
Secretary Burwell [continuing]. I think it is important to
reflect that the monies that are left are for very important
things.
In Sierra Leone, after it had been declared transmission-
free, 48 days later, we found another case of Ebola on a dead
body, because we were still swabbing, testing the dead bodies.
That is how we found it, and that is why we did not have
another large outbreak in Sierra Leone after we had been told
we did not have any cases.
This is a disease where we are not done.
In addition, a big portion of the money is for Global
Health Security Agenda. That is money Congress gave us. You
told us to put together 5-year plans to make countries meet
their marks before we would put the money out.
We have worked with those countries. They have put together
those plans, and we are going to put the money out on that
timetable.
It is important, because right now in Nigeria, there is a
Lassa outbreak. Lassa is related to Ebola. It is not the same
disease, but similar.
Last year, I did not come to talk to you all about it, but
we had the most cases of the Middle East Respiratory Syndrome,
which is even quicker to spread--respiratory--outside of Saudi
Arabia. It was in Korea. We were able to handle it because we
were prepared.
That Global Health Security Agenda money and those
countries' preparedness is our preparedness, because we are
only as prepared as that weakest link. And we do not know where
it is coming from. MERS, we have had a case in Indiana 2 years
ago.
We are in a world where it is our own domestic security
that we are concerned about.
Senator Blunt. The chairman of the full committee, Chairman
Cochran.
Senator Cochran. Mr. Chairman, thank you very much. This is
an excellent hearing.
Madam Secretary, we appreciate your cooperation with us in
reviewing the options for the funding levels in the bills that
come under the jurisdiction of our committee. It is a big
responsibility. It is a big problem, and States like mine,
where we have a higher number of people who have a hard time
getting access to and affording and paying for healthcare or
hospitals or doctor fees or education programs.
There are a lot of places where we can do a lot of good in
helping to make life more tolerable and enjoyable. That is what
really moves us.
CRITICAL ACCESS HOSPITALS
We get tangled up sometimes in the procedures and forget
what the big picture is. But money, for example, like critical
access hospitals, I am disappointed that the administration is
not requesting more funding for those facilities, where those
facilities are less than 10 miles away from the nearest
hospital. I hope we can look for opportunities to be more
sensitive and generous, and that means stretching dollars and
providing the bulk of the money where people would not have
access.
So what is your response to that? Are we doing the right
thing? Are we overdoing this? Are we denying emergency services
in life-and-death situations?
Secretary Burwell. So with regard to the issue of critical
access hospitals, I think it falls into the larger category of
rural health in America. That is something I am specifically
focused on too because where I am from, in terms of being from
West Virginia.
So there are a number of things in our budget that we are
doing to focus specifically on how we are supporting those
rural hospitals across the country. One of the things is our
proposal on community health centers. Thanks to all of you for
your support previously on this issue, because those community
health centers are disproportionately in the communities that
we are talking about. 38 percent of them are in rural America.
In addition, the proposal that we have in front of us will
increase the number of those with the same dollars from last
year, but we will be able to increase the numbers.
In addition, our National Health Service Corps, 40 percent
of the National Health Service Corps serves rural America. We
have proposed to increase the number of people that will be
serving there.
In addition, our proposal and some of the proposals we were
just talking about in the area of opioids are specifically
targeted to rural America. We also have some telemedicine
proposals that I think will particularly help rural America.
And I will say, in many States, the expansion of Medicaid
has made a huge difference to hospitals. What we see is that
the majority of hospital closures, and especially those rural
hospital closures, are closing in States where expansion has
not occurred.
There are many things that contribute. As we know, it is
about providers. It is about population density. But we are
already seeing those statistics. So those are a number of
things.
With regard to the specifics of the critical access
hospital issue, I think we believe those hospitals will still
receive disproportionate Medicare payments, and our analysis
says that hopefully that will be something that can help them.
Senator Cochran. I appreciate very much your personal
attention to that challenge.
Thank you, Mr. Chairman, for providing these increases that
we are submitting in our committee.
Senator Blunt. Thank you, Chairman.
Senator Murray.
PRESCHOOL DEVELOPMENT GRANTS
Senator Murray. Thank you very much.
Secretary Burwell, I really was pleased to see that you
have requested $100 million increase for preschool development
grants. As you know, the bipartisan Every Student Succeeds Act
marked for the very first time that our Nation's primary
education law authorized dedicated funding to improve access to
preschool for children from low-income and disadvantaged
families.
Now, the program will be funded at HHS, but it is going to
be jointly administered by HHS and the Department of Education.
The Department of Education has done great work in
collaboration with you to help States develop and sustain
strong early learning programs.
I wanted to ask you how is HHS planning to take advantage
of the expertise at the Department of Education with regard to
its early learning programs?
Secretary Burwell. We plan to work on the relationship that
we have had historically in this specific area in terms of how
we have jointly worked on it before when it was sitting at
Education, as well as how we work on a number of issues,
whether that is joint letters in the space that the Secretary
of Education and I do regularly in terms of when we want to
communicate or do policy efforts.
In order to make it so that it is more formal in terms of
making sure that we are going to follow that path and that
there are set parameters, we are actually working on a
memorandum of understanding, so that when the programs
switches--not in this fiscal year, but the next fiscal year, as
directed by Congress--when it moves to us, there is a
memorandum of understanding that will lay out specifically the
ways that we ensure that we are getting appropriate input from
our colleagues and run the program in a joint fashion.
Senator Murray. So you will be working in lockstep with
them?
Secretary Burwell. Yes. That memorandum of understanding is
something we will develop together, so that we put in place
processes that are formalized, because we want to build on what
I think has been more informal. But we would like to go ahead
and formalize it, because we think that will help us make sure
we succeed.
UNACCOMPANIED CHILDREN
Senator Murray. Great. Thank you.
As you know, there was a surge late last year in the number
of unaccompanied children crossing our southern border and
referred to the custody of HHS. Your department has used the
resources this subcommittee has provided to find temporary bed
space for those children should this trend continue.
Yet at the same time, the Associated Press and the Senate
Committee on Homeland Security and Governmental Affairs found
that your department did not adequately protect these children
after they were released to sponsors. Some of those children
were victims of abuse, neglect, and human trafficking.
In my view, HHS should be doing more than just finding bed
space for these children. Can you talk a little bit about what
changes in policies you have instituted since these stories
came out, that will help make sure that these vulnerable
children are protected?
Secretary Burwell. Yes. The safety of these children is our
priority. As you know, that is our role in this process. We are
tasked with placing the children as quickly as possible in safe
settings.
I think it is important to reflect what they were looking
at is a case in Ohio. That is a case where people broke the
law. As soon as we had any knowledge of that, we started
working with the Justice Department quickly to make sure that
we worked to prosecute to the fullest extent of the law with
those children. It is an awful situation that should not happen
again.
There were other accusations that a whistleblower made. We
looked into them. Our IG (Inspector General) has looked into
them. Our IG found that there was no substantiating evidence
that they had in front of them with regard to that.
Having said that, we have put in more what we consider
policies that will help address some of the issues to make sure
we are doing as much as we can. One, any adult in the home
where a child is being placed will go through a background
check. In any place where a child is placed in a nonrelative or
a distant relative setting, those are places where we are going
to work hard to make sure we are doing appropriate checks, some
of those even in the home and making sure we do home visits. In
addition, for anyone that is placed in a nonfamily member
setting, there will be follow-up services.
We have put in place an 800-number for the children
themselves, if they have concerns, so they can reach out.
One of the things about the funding though, and we had this
conversation last year, why we would actually like flexibility
in the funding is because we do not know the numbers and they
fluctuate. I think you all know it was 17,000 children in the
first quarter of this year. We have to make sure we have
funding to get the children off the border and have the beds.
The contingent fund that we have proposed would allow us
the flexibility to make sure that we know that we could provide
beds, but at the same time could think about other ways we can
enhance services. Right now, we are doing all of those things.
I think the question of us doing more is related to funding.
Senator Murray. Thank you.
Thank you, Mr. Chairman.
Senator Blunt. So the list I have, we will start with
Senator Alexander, then Senator Merkley, Senator Capito,
Senator Durbin, Senator Moran, Senator Shaheen, Senator
Cassidy, Senator Lankford.
Senator Alexander.
Senator Alexander. Thanks, Mr. Chairman.
Madam Secretary, first, let me thank you for the way you
work with the committee and with me and our office. Some of us
here in the Senate are in the results business, and a lot of us
are on this committee, and we like working with a Secretary who
works the same way, so thank you for that.
I have given you a letter about the so-called Medicaid
bump-up. I do not want to take my time with it here, but it
comes from our entire delegation. I believe there may be some
unintended consequences from a well-intended effort to
encourage more doctors to see Medicaid patients. So if you
would look at that, I would appreciate it.
Secretary Burwell. I will look into it.
Senator Alexander. Madam Secretary, I want to talk about
one subject. I want to ask for your advice and as much support
as you can give to the idea.
PRECISION MEDICINE INITIATIVE
This is an exciting time for science. Many of us believe
that here. There is an opportunity to help almost every
American with biomedical research. The President is for a lot
of things but among the few things he is really for is his
Precision Medicine Initiative. I know that, and I talked with
him about it a year ago. I attended his Precision Medicine
events, and I pledged to him that I would do my best to help
him create an architecture here in the next year that will put
us on a path toward the Precision Medicine, personalized
medicine, that he correctly talks about.
So the budget throws us a little curve. Senator Blunt
talked about that. It is not surprising. I mean, it happens
every year, really. For example, the Army Corps of Engineers,
the administration know we are going to put money back in, so
the administration cuts it way back.
But the idea that you would, in the discretionary fund
after we worked very hard--Senator Murray, Senator Blunt,
Senator Durbin, several of us--to have a significant increase
in discretionary funding to get on a path toward better funding
for the National Institutes of Health and you come in with a
lower amount of money in discretionary funding with the hope
that somehow some committee might authorize mandatory funding
or pass new taxes or something else, that is not very
encouraging.
So since we are in the results business, let me suggest a
path forward, and I will try to do this quickly, so you will
have a little time to answer.
The most important legislation in the committee that
Senator Murray and I chair is our biomedical innovation
legislation. It is a companion to the House 21st century cures
legislation. We have talked about it many times.
We are moving very well on it. We have 50 proposals that
are bipartisan, and we hope by early April to approve those in
the committee in a bipartisan way.
That is a train that should get to the station for the
Precision Medicine Initiative, the Cancer MoonShot, electronic
medical records, and anything that has to do with mandatory
funding for NIH. The only way I can see to get that there is to
approve these 50 proposals, most of them. That would be one
vehicle. And that would be bipartisan. I think we can do that.
The second vehicle would be a bipartisan consensus on
mandatory funding. I think about it a little differently than
just a big block of money. I want to see this committee
continue to increase our discretionary funding. I would like to
see the mandatory funding not be a substitute but to be in
addition, a surge of funding for such things as Cancer
MoonShot, Precision Medicine, and Big Biothink.
I think we could agree on that, find a way to pay for it,
and take those two bills to Senator McConnell, the 50 proposals
and the bipartisan proposal on mandatory funding in mid-April.
If we did that, I believe he would put it on the floor. I
believe we would pass it. I believe we could merge it with a
House bill. And the President would gladly sign it, because it
has so many things that are important to the future of our
country.
Now my question is, will you help us figure that out,
particularly with your budget background? And do you have any
advice?
Secretary Burwell. So I think we are completely aligned,
and I think you know, and we have had the conversation with
members of this committee, about the idea and the work on the
companion to 21st Century Cures here in the Senate. And we are
very appreciative for the work you are doing, especially in
electronic health records. We did an announcement on that as
recently as Monday that I think very much aligns with the
legislation that you all are considering blocking.
So that whole range of substantive issues that you are
focusing on, I think we are aligned on. We want to continue to
provide any technical assistance that we can and support for
figuring out how you get a companion that could be conferenced.
I think it is great that you are focused on the issue. I know
these are complicated issues, but the idea of mandatory funding
as the means by which we can move forward on these incredibly
important things--you listed them, Precision Medicine, the
issue of as we think through NIH, cancer----
Senator Alexander. Young Investigators, perhaps.
Secretary Burwell. I think it will probably also touch on
the BRAIN, in terms of----
Senator Alexander. Yes, absolutely. The BRAIN Initiative.
Secretary Burwell. So I think what I pledge to do is work
with you and the committee on figuring out how we can.
I understand the tough questions on what mandatory
discretionary caps, how we do this. I think what we want to do,
and what we are excited to do, there is agreement. These are
priorities for the Nation. And so how we can figure out ways to
get that funding, and to get the legislation, because that is
the other part of what you are speaking about on things like
blocking, on things like making sure that we can do our
investigations at NIH in more efficient ways, those are all
things that we are excited to work on.
Senator Alexander. Thank you, Mr. Chairman.
Senator Blunt. Senator Merkley.
Senator Merkley. Thank you, Madam Secretary.
Thank you, Mr. Chairman.
CHILDREN'S HEALTH
I want to raise two issues related to children's health.
One is a topic that I probably have had more discussions about
than anything else. And it will not surprise you that I wanted
to check in on the deeming rule.
The thing that concerns me so much is that, between 2013
and 2014, use of e-cigarettes by our middle schoolers and high
schoolers tripled. Addiction to nicotine is a pathway to a
lifetime of disease, a huge impact on quality-of-life for our
children, huge cost to the healthcare system. We have the
potential to do it differently.
But the rule has to emerge someday. While it is not
emerging, more and more children are being targeted by the
fancy flavors, the candy flavors, so on and so forth.
Is there any hope?
Secretary Burwell. Yes. In terms of moving the rule, I
think you know it had 135,000 comments, a complex rule with a
number of different pieces and parts to it. The one we are
focused on, e-cigarettes, certainly I think is the anchor
portion of the rule.
It is something that we will move. I feel confident that
this will occur. With regard to the specifics of the timing, I
am not sure that I can predict that. I think you know we do
rulemaking in partnership. So we will continue. I think you
know, and you and I have discussed my intent to make sure that
we do that.
At the same time, a number of steps have been taken in
addition. For the first time, we have actually done a no-sale
order on tobacco where we have providers who are not abiding by
the regulations. For the first time ever, we have said that
there will be providers who, because they have gone through a
number of times not abiding by the law, that they can no longer
sell.
In addition, I think you also know, with regard to liquid
nicotine, that we have an NPRM (Notice of Proposed Rulemaking)
that we are working on to continue to move forward.
So there is that rule. There are the other pieces that we
are continuing to work on in this space.
Senator Merkley. I know you have a lot of issues you are
concerned about, and this is one you do care about. I know it
is out of your hands in terms of OMB, but it is still in
partnership with your department. It is the potential for an
important healthcare win, so please stay at it, as you have
been.
Secretary Burwell. I will.
HIV NETWORK
Senator Merkley. Thank you.
Second, I want to turn to the HIV network. There is a group
of 18 research sites that participate in the HIV research
network that was established in the year 2000. It collects data
on 25,000 children, adolescents, and adults with HIV from
across the United States. Together, these sites provide a
unique source of information on delivery, disparities, cost-
effectiveness, the quality of HIV care. It has helped to get a
lot of insights about how we can address this disease more
effectively. Oregon Health Sciences University is one of those
18 sites.
This particular network is slated for elimination in the
2017 budget, which I think caught many of us by surprise. So I
just wanted to check in with your team. My impression is that
the valuable insights of tracking this disease and the routes
it is taking, so on and so forth, has contributed a lot to
treatment and care management.
I am hoping you can take a look at it and see if we get
your support to keep this network alive.
Secretary Burwell. I will look into this one. This is one I
am not familiar with, in terms of the change, so I will look
into it.
Senator Merkley. Thank you.
And I will just close with a comment. I appreciated the
ongoing funding for the National Institute of Nursing Research.
The NINR typically allocates about 7 percent of its budget to
research training to help develop more researchers who often
serve as future nurse faculty, which is facing a growing
shortage. They sometimes are able to address some of the pieces
that get left out of pure disease, science side--end-of-life
events, directives, bedside support, so on and so forth,
palliative care. I appreciate that the budget does provide $146
million to continue the institute. Thank you.
Secretary Burwell. Thank you.
Senator Blunt. Thank you, Senator Merkley.
Senator Capito.
Senator Capito. Thank you, Mr. Chairman.
Welcome to the Secretary, my fellow West Virginian. We are
very proud of you in West Virginia. I think that I said that
last year, and it continues to be so. Thank you for your great
representation and for your great communication with all of us.
OPIOIDS
I have a couple things quickly. President Obama came to
Charleston, West Virginia, to talk about the opioid issue. You
have put a lot of emphasis on it. You have mentioned this
medical-assisted treatment, greater emphasis in the budget on
that. Some of it is targeted toward rural areas. Am I correct
in that?
Secretary Burwell. That is correct. We already, in our
current funding that we have that you gave us last year,
communities with high need, and many of those are rural, so we
are using existing funds to do some of that targeting as well.
Senator Capito. The budget that was bumped up in December
with I believe it was an additional $100 million, have those
dollars been spent yet? We are working a bill through the
Senate right now.
Secretary Burwell. With regard to that, those monies are
going against the three priorities that we have articulated.
One is medication-assisted treatment. The second is making sure
that we do the appropriate work on prescribing. CDC, I think
you know, is about to issue new guidelines. We want to make
sure those guidelines get to the right people. The third area,
and this is where money is moving right now, is naloxone and
Narcan. So when you get to that situation where a person has
overdosed, we can try to save their lives.
Senator Capito. On the prescribing issue, I have been
working on an amendment to have the protocol set up for acute
pain, so if you have a toothache or something, what are
protocols for pain medications on that?
ALZHEIMER'S
Alzheimer's is another area of interest for me, just
formerly being a family caregiver for both of my parents, it is
emotionally challenging, and it is very expensive. I do not
think the training is in place. What kind of arenas are you
going into to try to help families and caregivers who are not
really trained for this to meet this enormous challenge?
Secretary Burwell. There is the money that is at NIH that
is more focused on the science, which I think gets to a little
bit of the caregiver issues in terms of, if we are better able
to do prevention and care for the individuals.
But the piece in terms of the caregivers themselves is more
at the Administration for Community Living. Last year, at the
White House Conference on Aging, I think it is every 5 years,
maybe every 10. But last year's conference, we spent a lot of
time, and we actually did regional meetings across the country.
This was one of the issues that we focused on, both in terms of
getting input for what would be the agenda when we came to
Washington, D.C., but also trying to make sure that we are
putting out as much information as we have as easily as we can.
But it is a place where I will say I think we can do more
and better.
Senator Capito. Yes, I would say, definitely. As the
population ages, it hits every family. It is very difficult.
I think the BRAIN Initiative is terrific. I know West
Virginia University is participating in part of that, and I am
very pleased about that.
HOSPICE
The other issue I wanted to talk to you about was hospice.
I am not sure, I think we have written to you. We understand
the need to audit Medicare providers, but some of our hospices
have a backlog of appeals at the Office of Medicaid Hearings
and Appeals, for hundreds of thousands of dollars. The local
hospice in my area, you are holding like over $1 million worth
of payments while they go through the appeals.
That is difficult on a nonprofit organization that I think
really has great services.
Is this a function of not enough administrative law judges?
What is the backlog here?
Secretary Burwell. So the backlog that we have in Medicare
appeals is related to a number of issues. It is related to
administrative law judges. We asked for the funding. We put
together a three-part strategy to reduce the backlog.
Number one is administrative actions that we can take to
create a process that works more quickly. We have taken those
steps.
Number two, we have legislation. And on the Senate side,
the Finance Committee actually has passed portions of that
legislation. We need statutory changes. It would be helpful to
get that.
And the third is money so we can actually increase our
numbers of administrative law judges.
Senator Capito. Have you asked for that in this budget?
Secretary Burwell. We have. We have.
Senator Capito. Lastly, you have mentioned two or three
times about a $419 billion savings in Medicare. When I was
looking through your statement, I noticed that you referred to
alternative payment models. What is an alternative payment
model, simply?
Secretary Burwell. An alternative payment model is
sometimes called an accountable care organization. These
alternative payment models are places where we pay for value,
not for volume.
So what that means is, instead of paying for the number of
services, you pay for an episode of care or the result for the
individual. We do that in working with providers and insurers
and others across the country.
The Center for Medicare and Medicaid Innovation is where we
do these demonstrations and experiments. We are already seeing
results. We have seen over $400 million in savings in terms of
these accountable care organizations.
So they focus on, you get the benefit if you get well
people, and you treat them for their wellness and the results,
versus service by service.
Senator Capito. Well, we will have to have an extended
discussion on that. It is very complicated.
Thank you very much.
Secretary Burwell. Thank you.
Senator Blunt. Senator Durbin.
Senator Durbin. Thanks a lot, Mr. Chairman.
Madam Secretary, thanks for being here. In this room at
this table sit some people who have done some amazing things in
this year's spending when it comes to medical research. And I
give special credit, of course, to the chairman and to Senator
Murray on this committee, Senator Alexander on the HELP
Committee.
Virtually 5 percent real growth at the National Institutes
of Health. It is a shot in the arm and an encouragement to
medical researchers that we are serious about our commitment to
biomedical research.
CDC, similar increases. I think CDC is our Nation's first
line of defense when it comes to national health security. We
should start describing it as such, because day in, day out,
year in, year out, that is their mission.
I was disappointed with your budget. I will accept Senator
Alexander's analysis that sometimes you cut in areas where you
know Congress is going to step in and fill the void. I hope
that is the case here.
But what the chairman said at the outset, counting on
mandatory spending to make up the difference is a risk I hope
we never take. We should do our part on the discretionary side,
and hope, as Senator Alexander described it, that we can
supplement that with some commitments on the mandatory side.
I just think we make a serious mistake--and Dr. Collins has
told me as much; I am sure he has told you--if we do not have
constancy in our commitment to biomedical research. There is
just a real question by researchers as to whether they ought to
take the risk and continue in the field, if there is
uncertainty about funding in the future.
So I am looking forward to working with you and Senator
Murray who bridges both committees, HELP and the Appropriations
Subcommittee, and Senator Blunt, to achieve that goal.
PRESCRIPTION DRUGS
I would like to ask you, if I might, on the issue of
opioids and heroin, 80 percent of heroin users start with
opioid prescription drugs. That is a number that has been
repeated many times. I would like to ask you about two things.
What is the responsibility of pharma when it comes to this
current challenge? They are generating, I am told, 14 billion
pills a year, opioid pills, enough to provide a 1-month
prescription to every adult American. Clearly, they are
flooding the market with product.
That has to be part of our calculation about why we find
ourselves in the position we are in.
Secondly, what are we doing in this world of pain
management? You and I have talked about this on the phone.
Understanding physicians have a responsibility when it comes to
pain management, understanding it is a subjective statement as
to whether I feel good or do not feel good, I think there is
still a question that should be raised as to whether there is
proper management by the physician when it comes to pain.
Handing someone 40 or 50 pills, as we have heard in
testimony in other committees, is overkill in many instances,
and putting more pills out into the potential illegal market.
So in those two areas, pharma's responsibility and the
responsibility of physicians, what would you suggest?
Secretary Burwell. So in regard to pharma, I think two of
the most important things that pharma can do right now is
develop true abuse-deterrent products for existing opioids. The
other thing is that they need to develop products for pain that
are not addictive, in terms of the research and the work that
they need to do in these spaces, at the same time making sure
that in all of their work that they are making clear the
dangers of addiction.
That brings us really to the bridge to the second issue,
which is the prescribing, and how the prescribing goes.
Ms. Capito mentioned bills and approaches to limiting that.
I think we believe right now one of the most important things
we can do is put out new prescribing guidelines and then make
sure people are trained in them.
I am sure you all have the same conversations I have with
physicians. When you talk to a physician and you say, how much
time did you spend in training on pain, and usually the answer
is a very small number of hours, if at all. So making sure that
we make the advances in terms of that.
At the same time at NIH, we need to continue our research
both on the opioid and the treatment of pain side and what work
we can do there.
So prescribing, though, is an essential key, as you
reflected. That large number pills, they are going out time and
time again. We want to make sure that we are doing everything
we can to do that.
The NGA (National Governors Association) just put out a
number of proposals that we think align with our three-part
strategy, and we are going to continue working with them as
well.
Senator Durbin. Some States are monitoring this, and others
are not. Shouldn't we have a national standard, if we are
dealing with a national crisis here? Why would we have
reporting in some States, so we can monitor abuses, and in
other States not have it?
Secretary Burwell. So prescription drug monitoring programs
exist in all States but one in the union. They are, as you are
reflecting, at varying levels of quality. And the other thing
that is a problem with them is their ability to talk to each
other.
I did speak with the Governors at the recent NGA about
getting regional compacts, so we can get some alignment. I have
2 years running have brought together representatives from each
of the Governors, all 50 States, so that we start sharing best
practices, so we can start to raise the level of these
prescription drug monitoring programs, because that is the
other thing if you talk to physicians. They say it is hard to
use--different technologies, number of clicks, those kinds of
things.
So working to get best practices and working to get them to
communicate across State lines, and I think in the Northeast,
we will get a regional compact.
Senator Durbin. Thank you.
Senator Blunt. Thank you, Senator Durbin.
Senator Moran.
Senator Moran. Mr. Chairman, thank you very much.
Secretary, thank you for joining us. Thank you for your
phone call inquiring about anything we were interested in
visiting with you about.
I am always interested in a number of issues that face
rural hospitals, community pharmacists. I would again express
my gratitude for the times that CMS, in particular, but your
department, has worked with us to try to solve individual
issues that create what appears to be insurmountable problems
for a community attempting to deliver healthcare to patients in
the region. I just would thank you for the past cooperation and
ask if you would continue that and encourage the folks who work
with you to understand the distinction and the difficulties
that many small town, rural providers face.
Let me focus for a moment on NIH. I apologize that I was in
the Commerce Committee, but perhaps you have addressed this.
But the mandatory issues that your budget raises are
troublesome to me, particularly in light of what occurred last
year. Congress is stepping up and increasing the support under
the leadership of this subcommittee and our full committee. I
would encourage you to work with us on budget solutions that
are likely to occur once--you continue to propose, in some
instances, user fees.
I chair the subcommittee on the FDA budget. User fees
there, mandatory spending here, are unlikely to be solutions to
the budget challenges that you believe your department faces.
WELDON AMENDMENT
Then I want to ask you a specific question related to the
State of California. This involves the issue of healthcare
provider coverage for abortion. Religious entities, as you
would know, have moral objections. They are protected by
something called the Weldon Amendment.
You were asked a year ago about this issue and indicated
that an ongoing investigation was occurring. The allegation is,
as you know, that California requires its providers to provide
abortion services. That presumably violates the Weldon
Amendment that prohibits that requirement.
Your answer a year ago was that the investigation was
occurring, and it would be completed expeditiously. It is now a
year later, and my question is, is it the opinion of the
department that the order of California is a violation of the
Weldon Amendment?
Secretary Burwell. With regard to this issue, I think you
know when it was raised with me, raised both externally but
raised by Members of Congress, we opened the investigation with
the concerns that have been expressed. The investigation is
still open, so my ability at this point to comment specifically
on the question you asked, we need to wait for the completion
and the finalized investigation for me to comment on the
specifics of what the outcome of that investigation is.
So we are not there yet. When we are, we will make sure we
communicate.
Senator Moran. That investigation has been ongoing for how
long?
Secretary Burwell. The investigation has been ongoing for
well over a year.
Senator Moran. Do you have any opinion as to when that will
be concluded?
Secretary Burwell. My hope is that it will be soon. I wish
I could give you a timetable, but I do not want to do that
because it is an open investigation.
Senator Moran. I will let my question stand for my concern,
criticism. I am worried that this is an issue, as you know,
that has differences of opinion about the outcome. But in my
view, the law is clear and California is violating the law. It
is the administration's responsibility to enforce the law. And
I worry that there may be a plan afoot in which this just
continues to the end of your term and the end of the
administration, as compared to fulfilling your
responsibilities.
Secretary Burwell. I hear your concerns, Senator.
Senator Moran. Thank you, Secretary.
Thank you, Mr. Chairman.
Senator Blunt. Thank you, Senator Moran.
Senator Schatz.
Senator Schatz. Thank you, Mr. Chairman.
Secretary Burwell, thank you for being here.
TELEHEALTH
The last we spoke, we were talking about telehealth, and we
were talking about the sort of two tracks to move on. Since
then, we have had some pretty good legislative collaboration.
Senators Wicker, Cochran, Cardin, Thune, Warner, and myself, as
well as a bipartisan group on the House side, introduced the
CONNECT for Health Act, which attempts to amend 1834(m) in such
a way that does not cost any money to the Treasury but also
improves outcomes and reduces cost.
My question for you is, we also talked about what you
thought you could do within the existing statutory authorities
to expand the use of telehealth. I wonder if you have an update
for me?
Secretary Burwell. We have expanded the number of
categories, that we will pay for in that space, so I think that
is one of the advances that we have made. We are also using
telehealth in situations right now with the tribes. Right now,
tribal suicide in the Great Plains is a very serious issue. Our
ability to get providers there for those children--it is child
suicide. So we are also working there in new ways to do that.
In addition to the administrative actions, though, there
are two important statutory actions that are part of this
budget that I think are important to highlight because we would
like to get these authorities. One is, in this budget, you will
see money for HRSA, and this gets to the rural issues that we
are focused on. HRSA, some of our federally qualified clinics,
can actually be the sites to do the telemedicine, so we can get
that access in rural America. There is money for that in this
budget.
The second area is in Medicare Advantage and helping us
make some changes statutorily so we can use Medicare Advantage
funding to pay for telehealth, because one of the prohibitions
to the growth of telehealth is the ability for it to be paid
for, so the question of whether providers will provide it or
not.
So we are doing things administratively. There is
legislative movement. Thank you for your leadership. And we do
have two very specific things in the budget that we think will
make a difference.
Senator Schatz. We will continue to support you on that.
Some of those provisions are included in our legislation, so
whichever vehicle ends up succeeding, I think we are on the
same page.
Are there additional administrative actions that are on
deck, or do you think you have pushed your authorities to their
limits?
Secretary Burwell. I think we have pushed our authorities,
although we continue to look and examine where we can continue
to add, as we have in terms of adding conditions. But I think
we need a little help in terms of the payment issues.
MEDICARE ADVANTAGE
The other place that we are working on, in terms of
administratively, I should mention, is as we are working with
accountable care organizations, coming back to Ms. Capito's
question, a number of the accountable care organizations are
using telemedicine as means by which they can serve their
patients better. So there are ACOs that are doing it.
Senator Schatz. Yes. Can you talk about the Medicare
Advantage proposed change? I think it is an important way to
make sure we can--for Hawaii, it is 40 percent, 50 percent of
the market. It makes a big difference, and it potentially
addresses some of the CBO concerns. So can you flesh that out
for us?
Secretary Burwell. Just the idea that if we can get to the
space, as you said. Medicare Advantage continues to grow, and
the coverage of Medicare Advantage across the country, not just
in Hawaii, there is deep penetration. So once we can change
that payer model, in terms of having Medicare Advantage, we
think we can lead as a government as a payer, and then others
will follow in terms of if we can set a standard and have that
access to do that.
Senator Schatz. Thank you.
Last week, CMS announced a partnership with Hawaii to help
navigate how to best leverage Medicaid in the effort to reduce
homelessness. We are encouraged by this partnership, and we are
thankful for working with the State of Hawaii.
We have a terrible problem with homelessness. It is unique
among the States, because of our geographic isolation and
because of our cost of living, in particular the cost of
housing.
As you know, a lot of these individuals are more likely to
have complex medical needs. Can you describe how HHS is
supporting efforts to permanently house medically fragile
individuals?
Secretary Burwell. Yes. So in addition to the work we are
doing directly on homelessness with Hawaii, the broader issue
that I think gets to issues that each of you probably face in
your State, in terms of the medically frail and other issues,
is right now as part of the Center for Medicare and Medicaid
Innovation--and this is just such an important place where you
all give us authorities and money--right now, we are actually
doing a demonstration to understand when people are coming into
the healthcare system, if you can establish whether there are
certain other needs that you can connect them to the services,
that then you can reduce healthcare costs.
What we know is so many people, the emergency room visits
have to do with other complications in people's lives. So what
we have seen in some work in the private sector is, when you
actually ask the question about if the person is homeless, do
they need connections, sometimes to behavioral health services
or other services, that we can actually reduce the cost,
because they become more adherent to the drugs. Sometimes they
are not taking the drug because they do not have food. If you
can get them connected to the right place to get the food, they
can take the drugs.
So there are a number of things that we think, as part of
what you all gave us in those monies, we will have to measure
and show that there are results financially and that you do not
reduce quality of care and hopefully you increase it.
So those are the places we are working on it.
Senator Schatz. Thank you very much.
Senator Blunt. Thank you, Senator Schatz.
Senator Cassidy.
Senator Cassidy. Hey, Secretary Burwell, how are you?
Secretary Burwell. Hello.
Senator Cassidy. It seemed to be a special pleasure when
you said it would be the last budget that you will present.
You know, we only have 5 minutes so if at any point I
interrupt, it is not to be rude. It is just to expedite.
A week ago, before Energy and Commerce, you were asked,
regarding the fact that the administration appears to be giving
$2 billion to the reinsurance program under the ACA (Affordable
Care Act), which CRS says contradicts a plain reading of the
law, knowing that you know that, knowing that you know of which
I speak, just for context, I think it is Section 1341. It is
the bottom of page 92, but it is 91 through 93, where this is.
On the Energy and Commerce Committee, they pointed out a
CRS memo that said that you were given this $2 billion
``appears to conflict with the statute.'' You said that you had
not had time to read the CRS report, but they gave it to you.
That was a week ago.
So any thoughts now, after having had a chance to review as
regards to why the administration appears to be conflicting
with the statute?
Secretary Burwell. Senator, we believe that we have the
authorities. As I mentioned in that hearing, we actually
published for comment and notice the approach that we were
going to take to use those authorities, and did not have any of
the concerns raised as part of that public process.
Senator Cassidy. Just to point that out, I can tell you I
have seen comments in which it is buried within a huge Federal
Register, so sometimes it is not seen until actually
implemented.
But it says, ``notwithstanding any other provision.'' I
think maybe that is what CRS focused upon. Let me see if I can
find it exactly here.
But nonetheless, it is very explicit. Money remaining
unexpended should be used to make--notwithstanding the
preceding sentence, any contribution shall be deposited into
the general fund of the Treasury.
So the fact that $2 billion, which explicitly was said to
be put into the general fund--do you have a legal memorandum,
which would justify your position as opposed to that assumed by
CRS?
Secretary Burwell. With regard to the decision that we
made, I know that any of our rulemakings and any of this would
have gone through our Office of General Counsel. With regard to
the question of a memo, I do not know if it was done in that
form.
I would say that we believe we have the authorities. And as
one looks at this question, it is an issue that I think we are
all concerned about, which is downward pressure on health care
costs.
Senator Cassidy. Now, if I may interrupt, again, we have
limited time. And that is what you mention on the Energy and
Commerce Committee.
There is a certain letter of the law and spirit of the law.
I think you are arguing now that that we, by the spirit of the
law, would want to decrease, et cetera. But the letter of the
law said that, notwithstanding any other provision, the money
shall be put back into the Treasury.
If your attorneys have had the chance to review that CRS
memo, could you share that with us, because if we are a Nation
of laws, whatever we think about the ACA, if we are a Nation of
laws, it cannot just be expediency. It has to be what Congress
passed. I voted against it, but Congress passed it.
There is a sense right now that it is expediency. It is not
the letter of the law, not even a kind of plain reading of the
law, CRS would put it.
If I may pause and move to something else, and I do not
mean to be rude, but there is just such limited time.
Next, I understand there is going to be a demonstration
project which would decrease--you mentioned earlier value-based
reimbursement for drugs. And currently, as we know, there is
the average sales price plus 6 percent. I think the fear in the
administration is that might be incentivizing the use of more
expensive medicines.
I am told there is a demonstration project that will be
rolled out in which that will be modified, if you will. You
know far more about this than I, so if you tell me I am wrong,
I will accept that.
What I do not know is, will it just be a decreased
percentage? Will it be ASP-plus 2 or ASP-plus 4? Or will there
be a different model in which value-based purchasing is going
to somehow be used to judge what should be the reimbursement or
the percent reimbursement on a drug being used.
Secretary Burwell. With regard to the specific of rolling
out a proposal, I want to be very careful. This is obviously
market-moving information, so I won't speak to the specific.
But with regard to the general point, I think there is
general bipartisan, actually, support for the fact that when
you pay someone based on X plus 6 percent, that you actually
are going to encourage the person in terms of their own
economic well-being to do that. So I can speak to the broader
issue.
With regard to the specifics, we will have more to say
soon.
Senator Cassidy. Okay. Got you.
My gosh, rarely do I exhaust my questions before the end of
my time, but we were so efficient, thank you.
I yield back.
Senator Blunt. Thank you, Senator Cassidy.
And there will be time for a second round here.
Senator Lankford.
Senator Lankford. I ask unanimous consent for his 39
seconds left over.
Senator Blunt. Denied.
Senator Lankford. Secretary Burwell, good to get a chance
to visit with you again. Thanks for the way you always come
through and answer our questions. I have many questions as
well.
HOSPITAL REIMBURSEMENT
Hospital Consumer Assessment of Healthcare Providers and
Systems survey, one of our favorite surveys when you are
checking out of the hospital to be able to kind of score your
own hospital, which is part of the ranking. You have mentioned
multiple times about the opioid issue. I have a concern,
hospitals have a concern, that they are being graded and
reimbursed based on how they treat pain in the hospital, and
that if someone leaves a hospital, which, frankly, by
definition, when you leave a hospital, you are going to
experience pain--you don't go there because of the spa
treatments--that if you leave the hospital with pain or feel
like the pain is not being taken care of while at the hospital,
which incentivizes the hospital to overprescribe, that they get
a bad score and they are not reimbursed as high.
The simple question is, have you looked at that language
lately? Have you evaluated the possibility that CMS is
incentivizing hospitals to overprescribe pain medicine, so they
get a higher reimbursement because their scores do not go down?
Secretary Burwell. Yes, we have looked into it. Mr.
Alexander raised this issue with me, and we have actually done
a look at it.
I think what is important to reflect is we are in the
middle of the look at it. An initial look in terms of the
analytics, the money is not enough. It is a very, very small
percentage. Having said that, I believe, and have gone back to
the team, that even if it is not about the economics, it may be
about prescriber's belief. And it may be that they behave in
ways that are not economically driven and, therefore, we need
to go at this again.
So yes, we have looked at it.
Senator Lankford. I would agree on that, and I would tell
you that hospitals do not tell me that the money is not enough.
Right now, they are counting every single penny. To them, that
is a significant issue, and there seems to be an incentive to
be able to push doctors--I am not saying that hospitals are
forcing them, but it is one of the questions they are going
back to make sure everyone--is everyone treating pain, because
we are going to ask them when they leave? That creates a very
perverse incentive.
RECOVERY AUDIT CONTRACTORS
Now let me talk about your favorite subject, RAC (Recovery
Audit Contractors) audits. I cannot imagine anything we would
want talk about more fun than RAC audits.
I questioned one of our hospitals of many just about how
RAC audits are going and what is happening with that. They sent
me 49 denials that they have. Thirty-nine of the 49 have so far
been overturned. All of these are related to a signature that
was not there, or a date or time was not there.
The question goes back to you, ``Was it medically
necessary?'' Yes, they were shown to be medically necessary.
But the RAC audit proposal and what we are trying to
approach with RAC audits, my understanding was this is going
after fraud and medical necessity. It seems to be a tremendous
amount of money. Just this one group is at $650,000 that was
about signatures and date and time.
Secretary Burwell. So we have changed our policy since our
last conversation that I hope in ways that will take care that.
So an audit, if one of these is overturned, as you just
indicated those were, people will not be paid. The other thing
is, if it is over 30 days, they will not be paid.
So much of the feedback that we have received from folks
like you and your constituents, we have taken into account and
now have different policies in place.
Senator Lankford. Is there a possibility to have a
financial incentive on the auditors themselves, that if they
are pulling files that are then overturned, that there is a
financial penalty on them?
Secretary Burwell. I think the economics for them in terms
of spending time on something you will not receive anything for
is an economic incentive. Is it enough----
Senator Lankford. Even if there is a small penalty in there
just to incentivize them to pay attention to it does help,
because if they scoop up a bunch and only 20 percent get
pulled, the incentive is to pull up a larger amount, because
then if only 20 percent are going to actually go all the way
through, get a larger amount with 20 percent.
There is a whole series of issues that are here. Dealing
with the contingency fee structure versus flat fee. Reducing
the lookback period so not as long. I think it is 5 years now,
if I remember that correctly. Lowering that a year, 6 months,
whatever it may be, so there is not this perpetual sense of a
long lookback on it. Trying to deal with good actors. When a
provider has consistently shown they have been good at it, not
pulling as large of a group. Trying to coordinate between the
RAC audits and ZPICs (Zone Program Integrity Contractors) to
make sure they are not getting both at the same time that are
coming at them.
A lot of issues that are out there that I would love to be
able to just send you some of these things. I know you are
working on them.
The issue about the reimbursement, they are not paid for
it. I understand that. That was taken care of a long time ago.
But there is still more to go. We are still creating a
hostile environment.
Secretary Burwell. So we welcome your suggestions and
thoughts, and I think one of the things we all want to do,
though, is make sure that we are eliminating fraud in the
Medicare system.
Senator Lankford. I would totally agree. That was the
intent at the beginning. Not giving the date, time, and a
signature in the right spot on the right sheet is not taking
care of fraud. That was medically necessary, but we are now
holding large files for it.
WELDON AMENDMENT
One last thing I want to get a chance to get to is going
back to something that Senator Moran had mentioned before on
California and the Weldon Amendment issues. Have you gone to
the Office of General Counsel to ask a legal opinion about
California and the Weldon Amendment? Has that been done?
Secretary Burwell. The Office of General Counsel will be
involved. The Office of Civil Rights does the investigation.
Senator Lankford. Correct. Has that formal request already
been made of them to give a legal opinion to you on it?
Secretary Burwell. With regard to the question, the General
Counsel's Office is a part of any of the conversations with
OCR. I am not sure when you say ``formal request.''
Senator Lankford. Just to be able to make sure--this is a
legal question that is out there that seems pretty cut and dry.
Yes, it is clear California is violating the law. I cannot
seem to find any wiggle room. And 18 months later, we are still
getting, ``We are still investigating.'' We want to find out
how thorough is this investigation after 18 months and a clear
violation of law.
Secretary Burwell. The General Counsel is deeply involved.
Senator Lankford. So can we get a copy of some of those
reports that are coming in, so we can track what is happening?
Secretary Burwell. We are in the middle of an
investigation, and when the investigation closes, we will
communicate----
Senator Lankford. Which you would expect by when?
Secretary Burwell. As I said to Senator Moran, at this
point, I do not have a timetable, but I do expect us to come to
closure.
Senator Lankford. Eighteen months is a long time to look at
something.
Secretary Burwell. I appreciate that.
Senator Lankford. So it is still unknown. It could be
another 18 months.
Secretary Burwell. I do not think it will be another 18
months, because I will not be here.
Senator Lankford. So it ends at the point?
Secretary Burwell. I do not want to commit to a time table,
but I think your question is, is this an issue that will become
resolved, I think it is your question.
Senator Lankford. Yes.
Secretary Burwell. And I look forward to doing that.
Senator Lankford. In your time.
Thank you. I yield back.
Senator Blunt. We will start our second round with Senator
Murray.
NALOXONE
Senator Murray. Thank you again, Madam Secretary.
We have talked a lot about opioids. You spoke about the
need to increase medication-assisted treatment to solve the
opioid crisis, the importance of naloxone.
Could you talk a little bit about how your budget increases
access to that lifesaving drug?
Secretary Burwell. With regard to naloxone or what some
refer to as Narcan, we are using some of the monies that we
have available right now. But a portion of the money, of the
$1.1 billion that we have asked for, would be for those.
What we would want to do is get that money to communities
so that first responders can get those treatments and get that
out. Some of the money would need to be used for training, so
we make sure people know how to use it. But we want to get the
money out.
In addition, we are complementing those efforts. The FDA
just approved recently the most recent nasal naloxone or
Narcan, which will mean that others can be able to give it out
in terms of people who are trained in terms of injections. So
we are working on that side of it as well.
Senator Murray. That is part of your budget?
Secretary Burwell. It is. The FDA, has already approved it
and is moving forward. But we want to make sure that the monies
will go toward whatever types of access people want, whether it
is injection or nasal.
ANTIBIOTIC RESISTANCE
Senator Murray. Okay.
As I said in my opening statement, I am concerned about
many pressing needs facing the subcommittee, but one area I did
not talk about that really worries me is combating antibiotic
resistance.
As you know, we face the prospect of living in a world
where antibiotics are no longer effective. Your request
includes an additional $40 million at CDC for the second year
of an initiative to address antibiotic resistance, which brings
the total to I believe to $200 million. I applaud that
increase. It is significantly less than you requested last
year, which was $264 million, and you are not requesting an
increase at NIH or BARDA for addressing antibiotic resistance.
So I wanted to ask you, where do we stand in our fight
against antibiotic resistance? And are NIH and BARDA developing
promising new drugs in the pipeline? Is there more to come?
Secretary Burwell. Yes. In terms of where the money is
focused, NIH is focused on making sure that we are developing
the antibiotics that are not resistant. At the same time,
diagnostics are also a very important part of this, in terms of
our ability for people to go and be tested and, no, you do not
need an antibiotic. Many people demand it because they think
that is what they need, and our diagnostics are not fast and
quick enough. So that is part of the research.
BARDA is deeply involved as the drugs and things are coming
through, and the research gets to the place where we can work
with the private sector to move those along. That is the part
that BARDA is playing.
I think with regard to our effort, it is both research and
there is the other part of the effort, which has to do with
animals and the question of prescribing in animals. Through FDA
rulemaking, we are working to get to a place where people only
prescribe actually for conditions in animals where there is
something wrong with them versus using these kinds of
antibiotics for growth and other issues.
Also making sure that when they are going to be used in
animals, that they are going to be used with a veterinarian, in
terms of prescribing and making sure that it is being used in
an appropriate form.
Senator Murray. So it is not blanket.
Secretary Burwell. That is right. So working on all of
those fronts.
The other place that I think that is very important--I am
glad you raised the issue. I just had the Global Health
Security Initiative group of countries that President Bush
started after 9/11. This is a group that met in October 2011 to
address--and it is our partners like Japan, Mexico, the G-7.
They are many of the partners.
This is an issue that we talked about specifically. There
is a lot of energy on antibiotic resistance, and I think we may
even hear conversations about it at this year's United Nations
General Assembly.
Senator Murray. Because it is an international discussion.
Secretary Burwell. Yes. So we have our plan. We have a
strategy as the United States, but we are also working around
the world and in partnership with others. The British have a
leadership role. The Germans have a leadership role here, too.
Senator Murray. Good. I really appreciate that. In talking
to doctors at the Children's Hospital in Seattle and hearing
that kids are born today resistant, and there is nothing they
can do when they are 4 or 5 days old. This is an increasing
problem.
WOMEN'S HEALTH
Finally, I wanted to ask you, for a lot of women, the
Affordable Care Act expanded coverage of all FDA-approved
contraceptives has reduced their out-of-pocket costs and given
them access to more effective methods. In fact, we know that
women have saved nearly $500 million because of this provision.
But unfortunately, we are still hearing from women
experiencing difficulty in getting guaranteed no-cost coverage
from their plans. I understand some insurance carriers are not
adhering to the requirements. I wanted to ask you if you knew
which carriers are requiring cost-sharing, are declining
coverage, or are otherwise limiting coverage for
contraceptives?
Secretary Burwell. Since we last spoke, we put out
additional guidance to the insurers to make sure they know. If
there are cases that you are hearing from your constituents, if
you can let us know, because then it becomes an enforcement
matter.
Senator Murray. Okay. That is really important, and we will
do that. I hope you will follow up on that.
Secretary Burwell. Yes.
Senator Murray. Great.
Senator Blunt. Thank you, Senator Murray.
Just as an aside, this is not really a question, but on the
mandatory funding issue, which I have great confidence that
Senator Alexander and Senator Murray and their committee are
going to look at in a way that does not slow us down with
discretionary funding, I will say the history of mandatory
funding would discourage you on that front.
Congress added mandatory funding for community health
centers. There has been no increase in that discretionary
account since that happened.
We had mandatory funding for the National Health Service
Corporation. There has been no discretionary funding at all for
that, since it went mandatory. I noticed in your budget this
year you are asking for discretionary funding again for the
National Health Service Corps.
It probably does not have to be that way, but I will tell
you it has been that way. Whenever there is a mandatory
component that steps in, the history has been that the whole
focus is on maintaining the mandatory component, not on what
used to be the discretionary funding. And I would hope that
would not happen again.
PAIN MANAGEMENT
Senator Murray had a question about antibiotics that led me
to another thought on pain I meant to make. Is there any
advance being made in trying to find less addictive pain
alternatives? What can we do to encourage that?
Secretary Burwell. It can happen in a number of different
ways.
One is the pharmacy question and making sure that
pharmaceutical companies are developing drugs that actually are
not addictive that can be treatments for pain.
Another place where we can make probably some advances is
actually in how anesthesia is done, because if anesthesia is
done in a way that a person does not have acute pain in the
first 24 to 48 hours after surgery--and it can depend on
anesthesia that was used to put you under.
I recently had a conversation with medical providers about
that issue. The Governors, actually, are the ones who brought
up that issue.
But I think the other place where we are as a government
working on it is actually the Veterans Administration. The
V.A., as I am sure you know, has a lot of patients with a lot
of pain. And one of the things that Secretary McDonald is
focusing on are alternative approaches to pain, whether it is
approaches like acupuncture or other issues that people can use
as alternative approaches to pills for pain.
So working across that whole suite of how we can treat pain
at the same time we reduce the prescribing, I think we need to
do both of those steps at once.
RAC AUDITS
Senator Blunt. I hope we can find solutions there and in
other places.
On the RAC audit topic, I appreciate what you have had to
say about that. I think clerical errors are not what we should
be headed for here. We obviously should discourage needless
clerical errors, but that should not become a reason to hold
somebody's money for multiple months at a time.
Last year, we provided a $20 million increase. It was a
little less than you asked for, but this year you have asked
for $90 million more. What do you think $90 million gets you
beyond where we are today?
Secretary Burwell. I think it gets us a major reduction in
the numbers. As I said, we want to work across a three-part
strategy. Our success is going to be dependent on the funding
of the administrative law judges, as well as some of the
statutory changes. If you get both of those together, I think
we can reduce this backlog much more quickly. So the
interaction of how much the money will help, but at a minimum,
we know we are increasing the productivity of our
administrative law judges by having the administrative changes
we are doing. We are increasing what is going to come in and
what we can process. Some of that has to do with settlements
and moving things through more quickly.
We have asked for the money that we think can put us on a
path to get that backlog down. I think you know, right now, it
is hundreds of thousands.
Senator Blunt. And what are you gaining by now looking at
clerical errors different than fraud, in terms of the backlog.
Secretary Burwell. I will have to go and check on the
specific issue of things like signature and how they go through
the system. I apologize, I do not know the answer.
Senator Blunt. Whatever you do there I think will be very
well-received by all of the people who are impacted, including
the committee, because we are constantly hearing from the
healthcare providers that we represent that they are winning
case after case after case, but the money is held for a long
time. By the time they get it, other problems have been created
because of the fact they did not have the reimbursement that
they were qualified for.
It sounds like to me, hopefully, we are headed in a much
better direction there.
I have a couple other questions, but Senator Cochran.
Senator Cochran. Mr. Chairman, there is some concern about
whether or not the Appropriations Committee's prerogatives are
being supported not by the administration in its totality. But
a review suggests that they are requesting funding through
legislation under the jurisdiction of the legislative
committees instead of through the Appropriations Committee.
Is this accurate or is my staff confused?
Secretary Burwell. Are they referring to the mandatory
requests?
Senator Cochran. Yes.
Secretary Burwell. I think this is a question, and we have
seen it. Mr. Blunt just gave the examples of where these issues
have crossed over. I think your point, Mr. Blunt, was not
successfully for the long term, I think.
But we have seen it occur on either side. I think this
comes to the question of where we want to be as a Nation with
regard to our levels of discretionary spending. And I think the
important issue that we try to meet in terms of the standard
that we know people care about is making sure things are paid
for, in terms of as we put the stuff on mandatory, we did not
just add to the deficit. We put in mechanisms overall that we
believe are paying for it.
The question of how we get there with the partial buyback
of sequester in already what were probably, some might say,
tighter levels before the sequester and how we do it, I think
it can be done in any number of ways. I think we are trying to
do it in a way that is paid for, but also sticks with the
sequester and the caps that are given.
How it works and whether or not the caps can go up, we
could move to a different place and pay for that again, as we
have starting with Ryan-Murray a number years ago, I think we
are open to the conversation. We try to provide monies so that
it can be covered. I think that is one of the most important
things, whether it is on the mandatory or discretionary side,
how it impacts the deficit.
Senator Cochran. Thank you.
Senator Blunt. Senator Alexander.
Senator Alexander. Thanks, Mr. Chairman.
I want to go back just for a moment to the question of
discretionary and mandatory funding again, particularly while
these three Senators are here and I am here and you are here.
NATIONAL INSTITUTES OF HEALTH
I agree with Senator Blunt. There is a real risk in
depending on mandatory funding for the increase we want to see
in a bipartisan way for the National Institutes of Health. Some
will want to see more and some will think we can afford less,
but there is an unusual consensus right now that we want to
take advantage of this period of time, this exciting period of
time in science that has the opportunity to help so many
people. And for my part, I am not interested in seeing
mandatory funding replace discretionary funding. I would like
to see us have a goal.
We did this in the Energy and Water bill to deepen our
harbors. We saw that as a national imperative and Congress said
this is the funding goal that we want over the next several
years, and we have met it for the last 2, and we are making
pretty good progress on deepening our harbors before the Panama
Canal widens.
Now this is a different and I would think more urgent
issue. So I would like to not think about mandatory funding as
a replacement for what we should be doing with discretionary
funding. I think we should build on the 5 percent increase of
this past year's discretionary funding and continue to move
upward and forward, if we possibly can.
That is hard to do, but that is our job to set priorities.
So I think about mandatory funding, and I am being a little
repetitive here, as in addition to that. When I think about it
that way, I want to make it hard for people to think of
mandatory funding as a substitute.
So one way, and several of us have talked about this, is to
have this innovation fund to take several areas where Dr.
Collins, you, the President have said these are urgent areas,
and they have a timeline and they have a beginning and an end.
So for example, we might add to the Precision Medicine
launch X billion dollars for X years. When that was over, it
would be gone. You could not say that is going to replace
discretionary funding.
The same with 650 more young investigators for a period of
time. Congress could replace that, but wouldn't have to. The
Big BioThink Award, Dr. Collins has talked about that, giving
each of the institutes an amount of money for the biggest idea
in their field to see what that turns up.
The Cancer Moonshot, we have yet to hear exactly what that
is, but we look forward to that.
Or let's take the BRAIN Initiative, Senator Cassidy even
suggested this the other day, and I thought it was interesting.
He said perhaps one way to think about it is as a surge of
funding. The mandatory funding would be a surge on top of the
discretionary funding.
So we would have the discretionary going up every year.
That would be our goal. But we can move there more rapidly if
we had a mandatory surge going on for the first 4 or 5 years,
and then they come together and we would be closer. I thought
that was pretty interesting.
So that is the way I am thinking about it, and I just
wanted to say those things while we are all here.
Secretary Burwell. Building on that thought and that
approach, as you think about medication-assisted treatment and
getting that initial capacity, the idea that what you need to
do because behavioral health and many of these issues are taken
care of at the State and local, and what we do is actually
jumpstart the State and local communities' ability to get to a
place where they have the capacity and then they take it on.
So to build on your idea, I think there are approaches that
we can think through that might work in terms of your approach
to thinking of it as additive, but not replacing.
Senator Alexander. If I may interrupt, if you did it that
way, let's say we had a 5-year surge to help launch Precision
Medicine, we would not have to spend the same amount every
year. In fact, that may be a waste of money. We might spend
some this year, some next year, the most the third year, less
the fourth year, and back down the fifth year. That might be
the most effective use of money.
That can be done with mandatory. That can be done with
mandatory funding.
So then I just want to reiterate the obvious. There is a
lot in the legislation that Senator Murray and I are working on
in support of Precision Medicine in addition to the money. The
electronic healthcare records that you have given a lot of
attention to, giving NIH researchers the authority to share
their data, more flexibility so you can have more arrangements
like the Google Vanderbilt arrangement that you announced the
other day, strengthen privacy protections.
That plus the electronic medical records are absolutely
essential to the Precision Medicine Initiative, as well as the
money.
I just want to reiterate, none of that is likely to happen
unless it is part of this bill we are doing.
So we have to get a result. We have to come to some
consensus. And I hope we do it by about mid-April.
Senator Blunt. Well, Secretary Burwell, on the research
component and, in fact, on many of the things we are talking
about, I think there is a commonality of goals here, shared
goals, that hopefully we can figure out how to take advantage
of. Our increase in NIH research was actually 6.6 percent. That
is 5 percent plus inflation.
That is a goal that Senator Durbin said that if we just had
that as our goal from now on, that would do a lot for families
that would do a lot for taxpayers.
A statistic that gets anybody's attention when I use it is
our projection that, on Alzheimer's alone, we are spending a
quarter of $1 trillion annually right now. We will be spending
$1.1 trillion of today's dollars by 2050, which is more than
twice the defense budget. Most people, including me, when you
say $1.1 trillion, that does not trigger a whole lot in my mind
that is more scary than some lower number than that. When you
say twice the defense budget, obviously, whatever we learn from
what will be relatively small investment in research is
important.
But if you are going to have a pattern, the second year of
a pattern is really important. So we did $2 billion, added $2
billion to the $30 billion last year. This would be a terrible
year to wind up cutting that by $800 million. This would be a
great year to add another 5 percent plus inflation, in addition
to whatever else we can do for short-term ways to move us
forward there.
MENTAL HEALTH
My last question is going to be on just mental health. I do
appreciate your stepping forward and looking at Excellence in
Mental Health.
Again, I will do just exactly what Senator Alexander did,
while I have Senator Alexander and Senator Murray here, I would
say when we were able to pass the demonstration projects on
Excellence in Mental Health, which has been very well-received
by the mental health community, the goal that Senator Stabenow
and I had when we introduced that legislation was that the
initial problem to be solved is having somewhere to go.
Having providers is really important. Various different
ways to handle privacy issues that might relate to your support
group is important. But if you do not have anywhere to go, none
of those things really matter.
I know you are looking at a way we can move from 8 to 14
States. We are talking to CBO about some numbers that might let
us move further than that, because I think, and this is the
question for you, I think what is generally believed to be the
case, and what initial studies have indicated, is that really
is it not only the right thing to do, but it really does not
cost anything in total healthcare dollars to treat behavioral
health like all other health because it is so much easier to
deal with every other problem that someone has that has a
behavioral health problem. And I will let you comment on that.
Secretary Burwell. Yes, I think it gets to the part of the
conversation that we had with the Senator from Hawaii in terms
of the importance of how these issues interact with our overall
healthcare cost whether it is behavioral health issues or also
the issues of homelessness, other kinds of things that inhibit
people from getting to the health they do.
I think you know we had put the money in to build on the
project that you and Senator Stabenow and Ms. Matsui on the
House side have been very engaged in. I think you know we have
worked with you to implement it faster than the statutory
deadline in terms of getting everything out, because we want to
shift very quickly to what you said. Where there is equity in
terms of behavioral health issues and places for people to go
to do it, we think we can do that in ways, as I think you
indicated, that can move us to a place where we have delivery
system reform, too, the way you have done it in terms of
quality measures, access for people, and getting to a base
where you get better quality at a more affordable price.
Senator Blunt. I think the way we have required the law
enforcement community and emergency rooms to become the go-to
place for behavioral health is outrageous.
Secretary Burwell. It is.
Senator Blunt. Just outrageous.
Also, on the opioid problem, and Senator Shaheen, we are
coming right to her, and this is an issue that she has been
very engaged in, in telehealth, I have an amendment that I
believe will be accepted on that bill that would allow
telehealth to also be part of the mix of things coming together
for dealing with opioids.
Senator Shaheen.
Senator Shaheen. Thank you, Mr. Chairman.
Thank you very much, Secretary Burwell, for being here
today.
Just to pick up on the comments about behavioral health, as
you both know, and the committee knows I am sure, that is a
critical piece of addressing the substance abuse problem that
we have in the country. We are not talking about just treating
overdoses and heroin and opioid abuse, but often there is a
mental health issue that accompanies that. So we have to start
looking at this as an integrated system that treats the whole
person.
DRUG ABUSE EPIDEMIC
I very much appreciate what you have put in and the
administration has put in to address the heroin and opioid--I
call it a pandemic, because that is what it really is. We are
losing 47,000 people a year. In New Hampshire, we are losing
more than a person a day due to drug overdoses.
The chairman talked about the emergency supplemental
funding that we tried to pass yesterday as we were trying to
get the Comprehensive Addiction and Recovery Act through. I was
disappointed that that did not pass, because as I have traveled
around, what I hear, whether it is the treatment providers or
whether it is families who have lost someone or are trying to
get someone into treatment or law enforcement professionals,
the issue is the same. And that is that they are looking for
funding because they do not have the resources they need.
Just to give one example, I do not know if you have talked
about this, but we have chronically underfunded the accounts
within Health and Human Services that allow us to provide
treatment and prevention. In fiscal year 2017, it would take
$483 million just to bring SAMHSA prevention and treatment
block grants back to the levels in 2006.
With that as a little background, can you talk about how
your budget will address the drug abuse epidemic and how you
are coordinating with other agencies within the Federal
Government to address this huge problem that so much of the
country is facing?
Secretary Burwell. Thank you for your leadership,
especially in the area of the funding issue, which I think you
know we think is critical and have discussed, because it is
what you just said, Mr. Blunt, in terms of, if people cannot
get access to the care, and if that is not available, and that
is the issue. As I said, I have talked to the sheriffs who say,
``I do not want to be a healthcare provider, and I do not want
to be a social worker, but I see this person again and again
and again. I have young men who are trained to do the law
enforcement, but not trained to help a person get off of their
addiction. We apply the Narcan, but then I am going to see them
again.''
So having that access and that is what the vast bulk of
that money goes toward, in terms of the medication-assisted
treatment. We need to build the capacity.
It is related to our behavioral health issues, that we do
not have the capacity that we need across the country. That is
why I am happy and open to thinking about, is it a one-time
shot to get the capacity?
But as you reflected, the budgets of SAMHSA and other parts
of our organization that deal with these issues have not grown
with inflation over the past years.
That is why I think it is a critical moment for the
increases that we need to see. I think more than anything, it
is about the problem and the magnitude of the problem, because
I do not know that one should argue that you should just grow.
I do not believe that, having come from OMB. So I don't believe
it is just about growth year over year. It is about need. So
that is where I would focus the issue of the money.
With regard to our coordination with others, we obviously
coordinate very closely with the Office of the National Drug
Coordinator, Mr. Botticelli at the White House, and also with
our partners. As I mentioned, V.A. is working on the pain
issue, so I have met with Secretary McDonald, so that they can
make progress in that space. I spent time with the Attorney
General.
The PDM piece that we discussed earlier, the Prescription
Drug Monitoring programs that I think it was Senator Durbin
raised. Much of that work is actually done out of Justice. The
other thing is drug takebacks are done out of Justice.
The other issues around heroin, we have talked about them
in conjunction with the opioids and the transition that people
make, but there is also the heroin coming into our country.
That is more a Justice Department issue.
So working coordination, those are the main pieces. But
also, as you know, Secretary Vilsack has become engaged on the
rural part of this and is helping us in that space as well as a
voice, a convener, and getting to one of the other attenuated
issues, which is economics. USDA's sole focus is on rural
economic development, so they are a part of that solution as
well.
Senator Shaheen. Thank you.
Mr. Chairman, my time is up. Can I ask one more question?
Senator Blunt. Go ahead.
ZIKA VIRUS
Senator Shaheen. Okay. Thank you.
I know that you are also focused on the Zika virus, and
what we need to do to get in front of that. As you pointed out,
it is very scary to think of what the potential impact of that
could be. We just had a woman in New Hampshire who was
diagnosed as having the Zika virus. Fortunately, she was not
pregnant, but she had gotten it through sexual transmission
with her partner who had been in the Caribbean.
Can you speak to the role of family planning, and the
accounts that are included in the budget and the role that they
play in the life of women and families as we look at something
like a potential Zika outbreak?
Secretary Burwell. I think one of the things we are very
focused on is making sure that everyone has the information
that they need to make the choices and decisions that they need
to make, and that they have access to the tools that they need
and want with regard to family planning and contraception.
Our budget, the supplement, proposes no changes to our
approaches in terms of making sure that there is access. We
talked a little bit about that access issue in terms of the
Affordable Care Act and the idea that you can do this without
copayments in terms of not being charged. So we are very
focused on making sure that people have the right information
to make the right choices for them, especially in the area of
contraception and protection.
I think you know we have recommended that there be no
unprotected sex for pregnant women who have partners who have
traveled to the region. That is the guidance that we have
offered from CDC during the entire time of the pregnancy. So as
we learn more, we will continue to put out updated guidance, as
soon as we get the research back.
I am hopeful that in the next bit, we will see more
research in terms of women and their pregnancies and
understanding if there is a more acute impact in that first
trimester, like we have seen with measles and rubella. Does it
follow that pattern or not? We do not know yet.
But as we get more information, people can make the choices
across-the-board with regard to prevention, as well as uses of
contraception during pregnancy.
Senator Shaheen. Thank you.
Thank you, Mr. Chairman.
Senator Blunt. Senator Murray.
Senator Murray. Madam Secretary, thank you. I just want to
clarify one thing, and then conclude. So your recommendation
from CDC is that even if a man travels in October and his wife
is pregnant, for 9 months, unprotected sex, coming back from
traveling to a foreign country?
Secretary Burwell. We recommend that they are careful
because right now we cannot determine how long Zika lives in
semen. We know that Zika lives in blood. Our research to date
has shown Zika lives in a person's blood system, in terms of
that, we think it is about a week after you have had finished
to the disease.
But remember, for 80 percent of the people, you do not know
if you have had it or not, because you are not symptomatic.
With regard to semen, we do not know yet.
Senator Murray. So it could be much longer.
Secretary Burwell. We do not know.
Senator Murray. All right.
With that, thank you very much. I do have additional
questions I will submit for the record.
But thank you very much, Mr. Chairman.
ADDITIONAL COMMITTEE QUESTIONS
Senator Blunt. Well, the record will be open for additional
questions.
One question I will ask for the record, but I want to be
sure it was heard today is, I have heard lots of concerns about
round three of the competitive bidding for durable medical
equipment, with some concern that we are rushing through those
changes too quickly and that they will have a negative impact
on seniors living in rural Missouri. I will have two or three
questions on that topic, and several others on other topics.
The record will stay open for 1 week for additional questions.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted by Senator Roy Blunt
risk corridor program
Question. The Risk Corridor program was designed to be budget
neutral over 3 years. In the first year of the program, insurers paid
$362 million into the Risk Corridor program while submitting $2.87
billion in payment claims. Had the Labor/HHS bill not continued a
general provision requiring the program to operate in a budget neutral
manner, the Federal Government would have lost $2.5 billion. Yet, the
budget request includes, for a second year, a request to eliminate this
provision. Why does the Department propose to eliminate this provision
when HHS has issued guidance stating the program should be implemented
in a budget neutral manner?
Answer. As in prior years, the Administration remains opposed to
including policy riders in appropriations bills because they are an
unwarranted limitation on Administrative flexibility.
It is important to note that we have made payments for the first
program year of the 3-year program. Additional risk corridors payments
for program year 2014 will be paid out of program year 2015 risk
corridors collections, and if necessary, program year 2016 collections.
We will not know the total loss or gain for the program until the fall
of 2017, when the data from all 3 years of the program can be analyzed
and verified. As we have said previously, in the event of a shortfall
at the conclusion of the 3-year risk corridors program, the agency will
work with Congress to provide necessary funds for outstanding payment.
Question. If the Risk Corridor account faces a shortage in its
final year, do you intend to use discretionary dollars to make payments
to insurers? Is that why you want the prohibition on using
discretionary funding contained in the Labor/HHS bill removed?
Answer. It is not possible to know whether or not other sources of
funding will be necessary. Additional risk corridors payments for the
2014 program year will be paid out of program year 2015 risk corridors
collections, and if necessary, program year 2016 collections. As we
have said previously, in the event of a shortfall at the conclusion of
the 3-year risk corridors program, the agency will work with Congress
to provide necessary funds for outstanding payment. We will not know
the total loss or gain for the program until the fall of 2017, when the
data from all 3 years of the program can be analyzed and verified.
Question. Will the Risk Corridor program be budget neutral over 3
years?
Answer. Risk corridor payments and charges are based on many
factors, including how issuers price their premiums compared to the
costs they incur, as well as any reinsurance and risk adjustment
payments or charges. Risk corridor collections from subsequent years
can be used to make payments for prior year shortfalls. We will not
know the total loss or gain for the program until the fall of 2017,
when the data from all 3 years of the program can be analyzed and
verified.
project bioshield
Question. Madam Secretary, in fiscal year 2016, the Subcommittee
provided $510 million for Project Bioshield, $136 million below the
President's request. For fiscal year 2017, you requested $350 million,
$160 million below fiscal year 2016. Why was there such a dramatic
funding reduction to this key national preparedness program?
What priorities changed?
Specifically, what happened to the 12 medical countermeasures that
were waiting to be purchased for Project Bioshield?
How will this reduction in funding impact our national
preparedness? Will the Department be able to purchase enough medical
countermeasures to protect the public?
Answer. Thank you for your ongoing leadership on this critical
national security issue. Project BioShield is a shared national defense
priority. The fiscal year 2017 President's Budget will enable us to
make meaningful progress on vital medical countermeasure procurements.
Unlike a grant or research program that supports a steady and recurring
level of effort, the Project BioShield budget is made up of a different
set of discrete procurements in any given year when medical
countermeasures are mature enough in development to meet FDA
requirements for accessibility under Emergency Use Authorization.
In addition to the fiscal year 2017 Budget request of $350 million,
the Department has obligated nearly $50 million already for the
purchase of anthrax antibodies out of the $510 million from the fiscal
year 2016 appropriation and has plans to obligate the remaining balance
on new medical countermeasures (new anthrax vaccine, lyophilized
smallpox vaccine, and radiation-related point-of-care biodosimetry
devices) in the coming months. In fiscal year 2017 the new resources
will enable the Department to procure small quantities of a few
additional chemical, biological, radiological and nuclear medical
countermeasures sufficiently mature for procurement, including:
--New Ebola vaccines and immunotherapeutics for the prevention and
treatment of Ebola infections.
--New high throughput biodosimetry devices to measure internal
radiation exposure following a detonation.
--New antibiotics for the treatment of bacterial biothreats and high
priority antimicrobial resistant bacteria.
--New diagnostics for the detection of anthrax in exposed persons.
--Replenishment of anti-neutropenia cytokines for the treatment of
radiation-induced blood illnesses.
In fiscal year 2014-2015, BARDA purchased five new medical
countermeasures under Project BioShield and anticipates purchasing
three new medical countermeasures in fiscal year 2016. Through its
advanced research and development program, BARDA has built a robust
portfolio of candidate products.
Additional candidates have the potential to transition to
procurement under Project BioShield in the future.
BARDA and the Public Health Emergency Medical Countermeasures
Enterprise (PHEMCE) are committed to maintaining our national
preparedness and making sure that medical countermeasures are available
when needed. Maintaining stockpiles of medical countermeasures
typically entails large procurement costs and is associated with
substantial carrying costs. In an era of constrained resources, BARDA
and its PHEMCE partners are mindful of the need to meet established
requirements, sustain preparedness, and be good stewards of the
taxpayers' investments. To this end, the PHEMCE is currently working to
refresh the material threat assessments that form the foundation for
our requirements, many of which have not been reassessed in years.
BARDA, for its part, emphasizes innovative approaches to total
lifecycle cost-containment and strives to decrease the long-term costs
of stockpiling medical countermeasures.
--One method is repurposing of commercial products and taking
advantage of their commercial market, under vendor managed
inventory (VMI). This method is currently being leveraged for
cytokines to address neutropenia resulting from exposure to
ionizing radiation.
--Another method that BARDA is employing is stockpiling of bulk
intermediates. Bulk products do not have expiry associated with
them like final drug products and can be maintained for longer
periods of time. Stockpiling of bulk intermediates also allows
BARDA to cut manufacturing times if additional product is
necessary for a larger event.
recovery audit contractors/medicare appeals process
Question. Madam Secretary, your budget provides significant support
for several levels of the Medicare Appeals Process but what are you
doing to address the root of the problem: the Recovery Audit
Contractors (RACs) who serve as the gatekeepers to the process? What is
the status of the RAC contracts that include the new requirements to
address these problems?
Answer. Recovery Auditors are important partners as we work to
identify and correct Medicare improper payments. In 2014, in response
to stakeholder and industry feedback, CMS took several steps to improve
the Recovery Audit Program to increase transparency and reduce provider
burden. For example:
--Hospitals should not be the only provider type subject to review by
Recovery Auditors. Recently announced additional documentation
request (ADR) limits will require diversification of ADRs
across all facility claims in proportion to the provider's
types of bills and will be based on provider risk, being
adjusted up or down based on a provider's denial rate.
--CMS established a requirement that Recovery Auditors must complete
complex reviews within 30 days, and failure to do so will
result in the loss of the Recovery Auditor's contingency fee,
even if an error is found.
--CMS has required Recovery Auditors to wait 30 days before sending a
claim to the MAC for adjustment. This 30-day period allows the
provider to submit a discussion period request before the MAC
makes any payment adjustment.
--Recovery Auditors will not receive a contingency fee until after
the second level of appeal is exhausted. This delay in payment
helps assure providers that the decision made by the Recovery
Auditor was correct based on Medicare's statutes, coverage
determinations, regulations, and manuals.
In addition, CMS is implementing a risk-based approach that will
allow Recovery Auditors to focus their reviews on providers who
demonstrate a high denial rate or have not changed their billing
patterns despite additional education, while focusing less on providers
following Medicare's rules. These and other program improvements to
reduce provider burden, enhance oversight and review accuracy, and
increase program transparency can be found here: https://www.cms.gov/
Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-
Compliance-Programs/Recovery-Audit-Program/Downloads/Recovery-Audit-
Program-Enhancements11-6-15-Update-.pdf.
As of November 16, 2015, all current Recovery Auditors signed
contract modifications that implemented enhancements to the Recovery
Audit program. The current Recovery Auditors will continue recovery
auditing activities at least through July 31, 2016 while CMS continues
the procurement process for new Recovery Audit Program contracts, which
will implement the remaining program enhancements.
Although the growth of Recovery Auditor appeals has contributed to
the Medicare Appeals backlog, the other types of workload are also
contributing to growth in appeals, and subsequently the backlog, in
significant ways. The increase in the backlog has resulted from growth
in each of the three workloads that HHS measures--Recovery Auditor,
traditional workload (Medicare Part A and B; Durable Medical
Equipment), and dual eligible workload, also known as the Medicaid
State Agency workload. Further, with administrative actions undertaken
by the Department to address the backlog, the current appeals in the
backlog that were generated by Recovery Audit activities represent only
a small fraction of the backlog.
My budget request for OMHA, the Department Appeals Board, and CMS
is an important component of the comprehensive strategy the Department
has developed to significantly reduce the backlog of Medicare appeals.
Taken together, the additional funding, administrative initiatives and
legislative proposals will help make sure beneficiaries and providers
have timely resolution of appeals.
world health organization guidelines for milk consumption
Question. In January, the World Health Organization (WHO) issued
draft guidance on milk consumption by young children. The guidance
proposes the establishment of significant new restrictions and
prohibitions on the promotion and marketing of milk products for young
children. It is my understanding that this proposal received little
public input and that when several Member States requested more time to
review the proposal, they were given four weeks. What is the Department
doing to ensure that such examination takes place and that U.S.
concerns about this proposal are properly taken into account by the
WHO?
Answer. At the request of Member States, the World Health
Organization (WHO) developed draft guidance on ending the inappropriate
promotion of foods for infants and young children, and presented it to
the WHO Executive Board for potential endorsement. This draft guidance
aims to support countries in protecting and promoting optimal nutrition
for children during the first 3 years of life, a critical window for
health and nutrition outcomes.
The WHO developed the draft guidance using a Scientific and
Technical Advisory Group process. Convened in 2013, the Scientific and
Technical Advisory Group produced several reports, including a draft of
the guidance that they presented to WHO in 2015. Following online and
in-person public consultations, the WHO presented a revised draft
guidance to Member States at the WHO Executive Board meeting in January
2016. Following the meeting, the WHO opened an additional consultation
period in February 2016 to allow time for further Member State comment.
The guidance is not binding on Member States.
The WHO draft guidance advises Member States on ending
inappropriate promotion to consumers of foods for infants and young
children. The draft does not seek to prohibit the marketing of all milk
products consumed by young children, to limit product availability, or
to revise recommendations for optimal infant and child feeding
practices. The document does recommend that countries prohibit the
promotion of breast-milk substitutes marketed for feeding children up
to 3 years of age.
In February 2016, HHS led a process to solicit input from relevant
Federal agencies and prepare a technical comment submission to the WHO.
HHS also met with multiple stakeholders, both individually and with
other agencies, on the matter. HHS transmitted comments and discussed
them with the WHO Nutrition Department, conveying that revisions are
needed to present Member States with clear, evidence-based
recommendations. The HHS Office of Global Affairs continues to monitor
the development of the draft guidance and will continue dialogue with
U.S. agencies and stakeholders in developing a U.S. position on the
issue for the World Health Assembly this May.
Question. It is my understanding the Department provided technical
comments to the WHO on the guidance. Please provide a copy of the
comments to the Subcommittee.
Answer. Please see attachment ``U.S. comments on WHO Guidance on
Ending the Inappropriate Promotion of Foods for Infants and Young
Children.''
weldon amendment
Question. The Weldon Amendment has been Federal law for over a
decade. It prohibits any State government receiving funds we
appropriate to discriminate against a health insurance plan that does
not cover abortion. Can you tell me how it is possible that
California's refusal to license such a plan is not discrimination in
violation of the Weldon Amendment?
Answer. The Department takes our responsibilities under the Weldon
Amendment seriously, and HHS supports clear provider conscience clause
protections. As you know, the Office for Civil Rights currently has
open investigations related to complaints of Weldon Amendment
violations. We cannot comment on the status of this particular
investigation because it is still an open case.
Question. The Weldon Amendment violations have been pending since
September 2014. Why is the investigation taking more than a year when,
fundamentally, this is a legal question? The Weldon Amendment is what
it is and California has issued its order.
Answer. I take our responsibilities under the Weldon Amendment
seriously. We cannot comment on the status of this particular
investigation because it is still an open case.
Question. Have you asked the Office of the General Counsel to
provide an opinion?
Answer. As expected given the legal issues involved, the Office of
General Counsel is involved in the issue.
strategic national stockpile purchases
Question. Since 2005, the CDC has stockpiled enough antivirals to
treat at least 25 percent of the U.S. population. This amount came from
recommendations outlined in the National Strategy for Pandemic
Preparedness. The budget requests $77 million for new asset purchases,
which is on top of the $345.5 million requested for expiring asset
replacement. Can you provide details on CDC's planned replacement
purchases, for both new and expiring assets?
Answer. CDC collaborates with the Public Health Emergency Medical
Countermeasures Enterprise (PHEMCE) to prioritize and adjust the
Strategic National Stockpile (SNS) formulary annually based on current
clinical practice, threats, market availability and available funding.
CDC also uses PHEMCE recommendations to prepare the SNS Annual Review
Report that informs HHS budget formulation for influenza antiviral
drugs and the other medical countermeasures held in the SNS.
The current PHEMCE recommendations for stockpiling goals represent
a shift in antiviral drug stockpiling from a shared Federal and State
responsibility to a solely Federal responsibility. Prior to 2014, the
goal was for the Federal Government to stockpile 50 million 5-day
treatment courses of influenza antiviral drugs with the remaining 31
million courses met through State stockpiling. PHEMCE recognized that
States were unlikely to continue contributing to stockpiling goals due
to:
--Limited funding;
--Decreases in staffing;
--Reduced risk perceived by States due to the presence of a Federal
stockpile; and
--Low ranking of influenza antiviral stockpiling as a preparedness
priority.
With the change to sole Federal responsibility, CDC is working
towards meeting the 80 million course stockpiling goal by increasing
Federal inventories.
The following table displays the stockpiling goals for influenza
antiviral drugs, as well as the SNS on-hand and on-order inventory
through February 2016.
----------------------------------------------------------------------------------------------------------------
Difference
Medical countermeasure treatment* in the SNS (courses in SNS SNS on-hand between On-order
millions) Stockpiling inventory goal and on- inventory
goal \1\ hand
----------------------------------------------------------------------------------------------------------------
Oseltamivir (Tamiflu) 75 mg capsules....................... 38.1 38.0 -0.1 0
Oseltamivir (Tamiflu) 45 mg capsules....................... 4.83 3.2 -1.63 0
Oseltamivir (Tamiflu) 30 mg capsules....................... 16.8 11.8 -5.0 0
Oseltamivir (Tamiflu) Oral Suspension** 6 mg/ml, 60ml 1.61 0.99* -0.62 0
bottle.....................................................
Zanamivir (Relenza) 5 mg blisters.......................... 19.2 16.4 -2.8 3.4
Total................................................... 80.54 70.39 -10.15 3.4
----------------------------------------------------------------------------------------------------------------
* One treatment course = twice daily administration for five days
** Does not include 500K of old suspension formulation that is expired and is in quarantine and awaiting
disposal.
\1\ The U.S. National Antiviral Strategy was updated in Jan 2014 and based on this revision, the target SNS
goals for influenza antiviral stockpiling increased from 50M treatment courses to 80M treatment courses.
This table shows current influenza antiviral products expiring
between fiscal year 2016 and 2022 as well as the projected replacement
costs for each fiscal year.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product in Projected replacement costs (millions of dollars)
inventory ----------------------------------------------------------------------------
expiring
Medical countermeasure treatment 2016-2022
(treatment 2016 2017 2018 2019 2020 2021 2022
courses)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Oseltamivir (Tamiflu) 75 mg capsules........................... 38.0M .00 .00 .10 20.14 33.98 251.83 184.03
Oseltamivir (Tamiflu) 45 mg capsules........................... 3.2M .00 .00 .65 1.33 .77 1.26 1.31
Oseltamivir (Tamiflu) 30 mg capsules........................... 11.8M .00 .00 1.27 1.76 3.29 1.67 4.27
Oseltamivir (Tamiflu) Oral Suspension 12 mg/ml, 25ml bottle.... 0.99M .00 7.73 .00 .48 .00 .56 1.55
Zanamivir (Relenza) 5 mg blisters.............................. 16.4M 90.64 72.95 31.81 .00 .00 37.19 122.37
Total...................................................... .......... 90.64 80.68 33.83 23.71 38.04 292.51 313.53
--------------------------------------------------------------------------------------------------------------------------------------------------------
strategic national stockpile replenishment
Question. The initial efforts to prepare for and fund the National
Strategy for Pandemic Influenza cost billions. How does the CDC
envision paying for the cost of replenishing the antiviral stockpile?
What is the cost estimate to replenish?
Answer. Projections for expiring product are incorporated into the
Public Health Emergency Medical Countermeasures Emergency (PHEMCE)
Multiyear Budget to inform enterprise decisionmaking and allow for
effective prioritization of medical countermeasure procurement in the
Strategic National Stockpile (SNS) and across the participating PHEMCE
agencies. These recommendations help inform the President's Budget
request for the SNS, while recognizing that the request must balance a
number of competing priorities. This will allow CDC to maintain SNS
Readiness to support response to pandemic influenza and other threats
to health security.
This table shows current influenza antiviral products expiring
between fiscal year 2016 and 2022 as well as the projected replacement
costs for each fiscal year.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product in Projected replacement costs (millions of dollars)
inventory ----------------------------------------------------------------------------
expiring
Medical countermeasure treatment 2016-2022
(treatment 2016 2017 2018 2019 2020 2021 2022
courses)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Oseltamivir (Tamiflu) 75 mg capsules........................... 38.0M .00 .00 .10 20.14 33.98 251.83 184.03
Oseltamivir (Tamiflu) 45 mg capsules........................... 3.2M .00 .00 .65 1.33 .77 1.26 1.31
Oseltamivir (Tamiflu) 30 mg capsules........................... 11.8M .00 .00 1.27 1.76 3.29 1.67 4.27
Oseltamivir (Tamiflu) Oral Suspension 12 mg/ml, 25ml bottle.... 0.99M .00 7.73 .00 .48 .00 .56 1.55
Zanamivir (Relenza) 5 mg blisters.............................. 16.4M 90.64 72.95 31.81 .00 .00 37.19 122.37
Total...................................................... .......... 90.64 80.68 33.83 23.71 38.04 292.51 313.53
--------------------------------------------------------------------------------------------------------------------------------------------------------
phemce multi-year budget
Question. The PHEMCE Multi-Year Budget released last March proved
very helpful in developing the fiscal year 2016 appropriations
allocation for the Project BioShield Special Reserve Fund. Can you
provide any details regarding when this year's Multi-Year Budget will
be released? And will this year's Budget include much-needed
information on pandemic influenza, which was not included last year?
Answer. HHS develops the Multi-year Budget in response to the
Reauthorization Act of 2013 (PAHPRA), which amended the Public Health
Service Act to require the Assistant Secretary for Preparedness and
Response to lead the development of a coordinated 5-year budget plan
and annually update the plan. This report covers the Public Health
Emergency Medical Countermeasures Enterprise (PHEMCE) estimates for
spending in fiscal year 2015-fiscal year 2019 based on professional
judgment on these programs. The report describes the importance of
programs that address specified threats identified through the Material
Threat Determination process used to set strategic requirements for
medical products. Projected estimates are based on specific assumptions
to maintain current preparedness efforts and projections are made
without consideration of other competing priorities that are reflected
in the formulation of the President's Budget. This year's multi-year
budget on PHEMCE will include additional information on pandemic
influenza. HHS is in the final phase of finalizing the report for
transmission to Congress.
zika virus response (genetically modified mosquitoes)
Question. The Zika Supplemental requests funding for vector control
activities. Is the Department exploring opportunities related to
genetically modified mosquitoes to suppress the population of wild
mosquitoes carrying Zika? Has the Department examined the possibility
of deploying this technology in the United States, U.S. territories, or
other countries?
Answer. Yes, the Department is exploring opportunities related to
using a genetically engineered (GE) line of the mosquitoe Aedes aegypti
to help suppress the population of wild type mosquitoes known to
transmit potentially debilitating human viral diseases, including Zika
virus, dengue, yellow fever and chikungunya. As you know, there has
been much interest in this proposal and we are working to ensure that
we meet applicable National Environmental Policy Act (NEPA)
requirements to ensure that the interested and affected public is
informed.
There has been public discussion about this new method to
potentially help control mosquito populations through the use of a GE
line of the mosquito Aedes aegypti (OX513A) developed by Oxitec, Ltd.
The release of male Oxitec GE mosquitoes is intended to cause
suppression of the mosquito population in a release area over time
because the offspring resulting from the mating of male GE mosquitoes
with wild type females do not develop to adulthood. Oxitec is seeking
to conduct a field trial to determine whether the release of its GE
mosquito will suppress the local Aedes aegypti mosquito population in
the release area at Key Haven, Florida.
The NEPA requires Federal agencies to assess the environmental
impacts of certain actions. Pursuant to Food and Drug Administration
(FDA) regulations, sponsors opening an Investigational New Animal Drug
(INAD) file must submit either a draft environmental assessment (EA) or
a claim of categorical exclusion from the EA requirement. The FDA also
released a preliminary finding of no significant impact (FONSI) that
agrees with the draft EA's conclusion that the field trial of such GE
mosquitoes will not result in significant impacts on the environment.
After the close of the required 30-day public comment period, FDA
will review and consider relevant comments. The FDA will then either
issue a final EA and FONSI, or prepare an environmental impact
statement (EIS). The field trial cannot begin until the environmental
assessment is complete. Once FDA has issued either a final EA and FONSI
or an EIS, the company and its local partner (the Florida Keys Mosquito
Control District) will decide when to begin the field trial.
community behavioral health clinic demonstration
Question. Madam Secretary, the budget's mental health initiative
requests funding for six additional States to join the Community
Behavioral Health Clinic Demonstration which is based on my Excellence
in Mental Health Act. I believe that if you treat mental health like
all other health, and if those suffering from a mental illness have
access to care we would see overall healthcare costs go down. Can you
speak to any healthcare savings we might see if we expanded access to
care? How much cost savings would result in healthcare expenditures in
the future by supporting all 24 States that currently have the planning
grants?
Answer. Thank you for your leadership on this legislation and your
continued engagement in the demonstration project. We are excited about
the Community Behavioral Health Clinic Demonstration and confident that
it will promote high quality, community-based services for mental and
substance use disorders. We are hopeful that the demonstration will
show both the benefits of increased access to behavioral health
services and coordination of behaviorial health services with primary
care services, and the potential savings that could result from earlier
treatment of a variety of conditions. However, at this stage in the
demonstration, it is not possible to reliably predict the extent of any
savings.
durable medical equipment
Question. Rural providers of Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies (DMEPOS) are facing payment
reductions between 30 and 50 percent from the Center for Medicare and
Medicaid Services (CMS) under Round 3 of Competitive Bidding. These
reductions are currently being phased in over a six month timeframe. In
the past, CMS has provided multiyear transition. Why is CMS applying
such an expedited phase-in for these suppliers who provide important
medical equipment and services that allow patients to remain in their
home?
Answer. Section 1834(a)(1)(F)(ii) of the Social Security Act, as
added by section 6410(b) of the Affordable Care Act of 2010, requires
that CMS adjusts the DMEPOS fee schedule rates for competitive bid
items using information from the DMEPOS competitive bidding program
beginning January 1, 2016. We are phasing in these adjustments to the
payment amounts to allow time for suppliers to adjust to the new
payment rates and would allow time to monitor the impact of the change
in payment rates on access to items and services. We believe a phase in
of 6 months provides suppliers with an adequate amount of time to make
adjustments to their businesses in light of the reduced payment
amounts. In addition, CMS will be closely monitoring access and health
outcomes using real time claims data and analysis during this period.
If there are any issues identified through our monitoring, we will take
appropriate actions depending on the situation.
Question. As part of the final rule establishing the modified fee
schedule, CMS indicated that they will monitor the impact of the rate
reductions using real-time data. What specific data does CMS plan to
use?
Is there a delay in data and if so, how will CMS address that delay
given the abbreviated phase-in timeframe?
What specific criteria will CMS use to assess whether these
reductions have interfered with patient access?
Answer. CMS has been using a real-time claims analysis to monitor
health status results in the DME competitive bidding program and other
Medicare payment systems. The analysis for the DME competitive bidding
program includes key indicators of the health status of beneficiaries
and their access to DMEPOS items and services such as deaths,
hospitalizations, emergency room visits, physician visits, admissions
to skilled nursing facilities, average number of days spent
hospitalized in a month, and average number of days in a skilled
nursing facility in a month. We also monitor beneficiaries who no
longer have claims for a competitively bid item after the program
began, beneficiaries who may at some point need the item, and
beneficiaries who currently have claims for competitively bid items.
CMS is doing a similar type of analysis and monitoring for the adjusted
DME fee schedule rates during the 6-month transition period and after
this transition period. In addition, CMS will be monitoring assignment
rates of suppliers. Assignment means that the suppliers have agreed to
accept Medicare allowed rate as full payment for the DME item.
Question. If suppliers are unable to continue caring for patients
due to these reductions, will there be options for rural patients to
continue to receive access to supplies and services in their home?
Answer. CMS established a special rule for adjusting fee schedule
amounts used in making payment for the item or service in areas within
the contiguous United States that are defined as ``rural'' areas. For
the purpose of implementing this rule, a rural area is defined as a
geographic area represented by a postal zip code if at least 50 percent
of the total area included in the zip code is outside any Metropolitan
Statistical Area. In addition, a rural area includes a geographic area
represented by a postal zip code that is a low population density area
excluded from a competitive bidding area. For these areas, in no case
will a fee schedule amount for any DMEPOS item furnished in the area be
reduced below the national ceiling amount, which is 110 percent of the
average of the regionally adjusted rates.
CMS will be closely monitoring access and health outcomes using
real time claims data and analysis during this period. If there are any
issues identified through our monitoring, we will take appropriate
actions depending on the situation.
fiscal year 2017 medicare advantage rate notice
Question. On February 19, 2016, as a part of the fiscal year 2017
Medicare Advantage Rate Notice, the Center for Medicare and Medicaid
Services (CMS) proposed a reduction to Medicare Advantage Employer
Group Waiver Plans (EGWPs), also known as Medicare Advantage Retiree
Coverage. 3.3 million seniors, including nearly 37,000 Missourians,
receive their Medicare Advantage coverage through these plans. While
producing an analysis of the impact of many provisions proposed in the
Advance Notice, CMS did not provide an impact analysis on these
proposed reductions. On March 7, 2016, CMS released an impact analysis
confirming a negative 2.5 percent cut to Medicare Advantage Retiree
Coverage. The information was released after the comment period was
closed, which ensures that the public is unable to comment on the new
information. A Milliman report and an Oliver Wyman Report both provided
similar estimates to CMS's impact analysis. Did CMS consider the impact
the reductions to Medicare Advantage Retiree Coverage would have on the
3.3 million seniors who depend on this form of coverage when developing
the Advance Notice?
Answer. Employer Group Waiver Plans (EGWPs) serve specific employer
groups, and are either offered through negotiated arrangements between
Medicare Advantage plans and employer groups or by the employer
directly. Because of the nature of these unique agreements, EGWPs do
not compete against other plans through the bidding process, and
therefore have little incentive to submit lower bids. CMS has
previously waived bidding requirements for Part D for EGWPs and set
payment amounts for Part D plans based on the competitive bids
submitted for non-EGWP Part D plans. In the 2017 Draft Call Letter, CMS
proposed a similar waiver and payment policy for EGWP Part C plans for
2017. This proposal would provide Medicare Advantage EGWP plans with a
fair benchmark, reflective of comparable local Medicare Advantage
trends and prices. CMS believes that waiving the requirement to submit
2017 Part C bids will facilitate the offering of Part C plans for
employers and unions seeking to establish high quality coverage for
their Medicare eligible retirees by avoiding the cost and
administrative burden of submitting complex bids. CMS will consider
comments we receive on this and other proposals in the draft Call
Letter.
Question. Why did CMS fail to include this cut in the agency's
calculation of the overall Medicare Advantage Advance Notice impact
analysis initially?
Answer. In the Advance Notice of Methodological Changes for
Calendar Year 2017 for Medicare Advantage Capitation Rates, Part C and
Part D Payment Policies, which was released on February 19th, CMS
proposed to change the methodology for Part C payments to Employer
Group Waiver Plans (EGWPs) without providing an estimated impact.
Impacts are not always provided for all proposed changes in the advance
notice. In response to subsequent inquiries regarding the impact of the
proposal, we provided an estimate of the expected impact of the
proposed change for Part C payments to EGWPs.
unaccompanied children
Question. In the summer of 2014 there was a sudden and significant
increase in children coming to the United States from Central America.
There was then a sudden decrease at the end of 2014 through most of
2015, another significant increase at the end of 2015, and now a
decrease through the beginning of 2016. What is causing these
significant swings? Has the situation in Central America changed over
this time? Has Mexico's enforcement strategy changed over this time?
Answer. HHS receives regular briefings from the intelligence
agencies on conditions in Central America. We know that many of the
unaccompanied children crossing the U.S. border are fleeing poverty and
violence, or seeking to rejoin their parents or close relatives.
However, interagency partners' analysis on the situation on the ground
does not indicate that conditions in these countries have changed in
ways that can easily explain the volatile fluctuations in the number of
children coming to the United States. The Office of Refugee
Resettlement (ORR) is involved in ongoing operational communication
with partners to monitor and analyze trends and works with several
components of the Department of Homeland Security on a daily basis on
the referral and transport of unaccompanied children from the border to
ORR shelters.
Question. These significant swings in the number of children coming
to the United States from month-to-month makes it difficult for HHS to
budget for the unaccompanied children program, but it also makes it
difficult for this Committee to judge budget requests. How is the
Department coordinating between different Departments to get a better
grip of the trends driving the fluctuations in children coming into
this country?
Answer. The Office of Refugee Resettlement (ORR) continuously
monitors and analyzes the trends of referrals of unaccompanied children
to HHS custody. In addition, ORR engages with interagency partners on a
regular basis to better understand migration trends and the
sociopolitical dynamics currently existing within the home countries.
ORR coordinates with interagency partners through the Unified
Coordination Group (UCG) created in 2014 in response to a Presidential
directive to ensure unity of effort across the executive branch in
response to the sharp increase of unaccompanied children arriving at
the southwest border at that time. Since then, the UCG has continued to
meet regularly to continue coordinating to plan for and respond to
shifts in numbers of unaccompanied children. ORR also works with
several components of the Department of Homeland Security on a daily
basis on the referral and transport of unaccompanied children from the
border to ORR shelters. ORR also coordinates with staff at the
Department of Justice (DOJ), the General Services Administration (GSA),
the Department of Defense (DOD) and the State Department on various
aspects of the unaccompanied children program that intersect with their
operations and responsibilities. UCG members routinely compare trends
with historic annual and seasonal patterns. Given how much the number
of unaccompanied children has fluctuated in the last couple of years,
it is difficult to accurately predict the number of children that would
be referred to ORR.
Given the range of external factors that may affect the number of
children coming into HHS care, it would be prudent for Congress to
provide access to additional funding that would allow ORR to
accommodate higher than expected caseloads. For instance, referrals to
the unaccompanied children program in fiscal year 2014 were the highest
on record for the program, requiring the deployment of temporary
shelter facilities as well as the expansion of standard shelter
capacity. However, referrals to the program in fiscal year 2015, though
still the second highest year on record, were substantially lower than
the prior year, and allowed ORR to reduce the costs associated with
shelter budgets during the low season referrals. Referrals in the first
quarter of fiscal year 2016 were significantly higher than during the
same period in previous years. While they decreased significantly in
the second quarter of the current fiscal year, they still exceed second
quarter referral levels for every prior year except for fiscal year
2014. Since mid-March, we have begun to see the numbers rise again.
These fluctuations in just this fiscal year alone underscore the
unpredictable nature of referral numbers, and creates serious
operational challenges for ORR as they budget for beds across the
fiscal year. The President's fiscal year 2017 budget request creates a
contingency fund that would trigger additional funds, not to exceed
$400,000,000, if referrals were higher than could be supported with
base program funds and any carry over funds for the program from the
prior year. The Administration estimates that the cost of the
contingency fund in fiscal year 2017 would be $95,000,000 based on the
probability that additional funds would be outlayed.
The lack of contingency funds in fiscal year 2016 has hindered
HHS's ability to plan for a full range of scenarios including having
the number of unaccompanied children coming into its care increase
significantly during the latter part of the fiscal year. While base
budgetary resources are sufficient to accommodate a significant
increase over current referrals, if the number of referrals spiked
suddenly to levels above those seen in fiscal year 2014, resources
could prove inadequate. If such a spike were to occur late in the year,
when it would be difficult for Congress to respond, HHS could be left
with insufficient resources to house these children. This is why a
contingency fund mechanism is so critical to ensuring that if an
unexpected increase in referrals occurs, the Federal Government is
equipped to provide appropriate care to children. We welcome the
opportunity to explore these issues further with the Committee and
discuss mechanisms that would ensure that HHS has the resources
necessary should an unexpected increase, particularly one that occurs
late in the year, arise.
funding for early childhood care and education
Question. The fiscal year 2017 budget request includes significant
increases in funding for Head Start, the Child Care and Development
Block Grant (CCDBG), and Preschool Development Grants. Particularly now
that Preschool Development Grants are funded within HHS, what is the
Department doing to ensure these programs are well coordinated at the
Federal, State, and local level and that we aren't duplicating efforts?
Answer. The Department of Health and Human Services (HHS) and
Department of Education will continue to jointly administer the
Preschool Development Grants program in 2017 and beyond HHS has worked
closely with our colleagues at the Department of Education to ensure
that our programs are coordinated, serve our Nation's children as best
as possible, and create a continuum of high-quality early learning
services beginning at birth and continuing through age five.
The Departments have had success in the joint administration of
Race to the Top-Early Learning Challenge and Preschool Development
Grants in previous years and engage in numerous other activities to
ensure coordination at all levels. For example, the Departments co-
chair an Interagency Policy Board on Early Learning, that coordinates
policy, programs, research, and technical assistance across agencies
and issues joint policy statements on key issues, including the
inclusion of young children with disabilities in classrooms and
programs with typically developing peers and preventing and eliminating
the expulsion of young children from early childhood programs. Other
examples of collaboration include the joint development of Birth to
Five: Watch Me Thrive, which provides a toolkit to increase rates of
developmental screening and follow-up and dissemination of materials
highlighting how to utilize Medicaid to support creating school
environments with physical and mental health supports.
We appreciate the importance of close coordination in the joint
administration of the Preschool Development Grants Program, and will
continue to keep your staff updated as we proceed with planning and
implementation.
Question. The Department has proposed regulations that would
increase the length of the Head Start school day and year, to increase
the duration of services provided, which is consistent with research on
what characteristics of early childhood education are most important.
Similarly, the CCDBG Act of 2014 includes important reforms that
require States to take steps to improve the quality of child care
programs. In light of these important and costly proposed reforms, why
has the budget proposed a $100 million increase for Preschool
Development Grants, and not focused all available resources on changes
underway in Head Start and CCDBG?
Further, why has the budget proposed $40 million of the increase
for CCDBG for a new competitive grant program instead of focusing those
resources on State efforts to comply with the new requirements in the
CCDBG Act?
Answer. We appreciate your work on the passage of the Child Care
and Development Block Grant Act of 2014 and your continuing support for
implementing the law's new provisions. The fiscal year 2017 Budget
includes an increase of about $200 million for the Child Care and
Development Block Grant (CCDBG), and the majority of this increase is
focused on helping States and communities to implement the new
requirements of the law. Of the total increase, $40 million will be
used for competitive grants to States, territories, tribes, local
governments, and public entities to develop, implement, and evaluate
approaches and innovative models of providing the types of care that
working families need most. These grants are part of CCDBG, rather than
a separate program. The focus will be on two areas: (1) care during
non-traditional hours, and (2) care in rural areas. This funding is
fully in line with the reauthorized CCDBG Act, which included a
provision that requires States to develop and implement strategies to
increase the supply and improve the quality of child care services for
certain populations, including children in underserved areas (which may
include rural areas) and children who receive care during
nontraditional hours. The goal of these pilot grants is to help States
and communities to meet this new provision, as well as other provisions
in the law.
Despite large numbers of families with non-traditional work hours,
the National Survey of Early Care and Education found that only 8
percent of center-based early care and education programs offered
services during non-standard hours. Home-based providers are more
likely to provide non-standard hour care, yet such care was only
available from 34 percent of home-based providers who appear in
official State and national lists of early care and education services.
Families living in rural communities also face unique challenges when
accessing high-quality child care due to the lack of affordable child
care, lack of public transportation, and the longer distances families
must travel between work, home, and child care settings.
These pilots will provide dedicated resources that will support
States and communities to identify and implement innovative solutions
to serving these populations and populations specified by Congress as
critical to address. The lessons learned from these pilots can then
inform nationwide efforts to meet the goal of the CCDBG reauthorization
legislation directing States to increase supply for underserved
populations.
The Budget also requests a total of $9.6 billion for Head Start, an
increase of about $434 million from 2016. This increase includes $142
million for a full cost-of-living adjustment for all grantees,
including Early Head Start-Child Care Partnership grantees. This
funding would ensure that Head Start and Early Head Start grantees can
maintain the number of children served and the quality of their
program. The increase also includes an additional $292 million over
2016 to enable more Head Start programs to offer full school day and
year services, which, as you mentioned, is based in high-quality early
childhood education research.
The increase in Preschool Development Grants is necessary to expand
upon the efforts already underway in the 18 States that make up the
first cohort of grantees. This additional funding would enable HHS and
ED to fund new grants under the reauthorized Elementary and Secondary
Education Act (ESEA) program in addition to supporting the final year
of continuation grants for the first cohort. The new grants will
improve the overall quality of preschool programs while improving
coordination across early learning systems and increasing parent choice
and knowledge about these programs. Ultimately, if all children are to
have access to high quality pre-K programs, State efforts must be
supported. This investment will also support and enhance many of the
activities required under the reauthorized Child Care and Development
Block Grant.
The fiscal year 2017 Budget request reflects the Administration's
overall strategy to expand access to high quality early learning
programs by improving the quality of existing programs and expanding
the availability of high quality pre-K opportunities. This means
investing in Head Start and child care while helping States to build
high quality pre-K opportunities for 4 year olds.
Question. What does the Department estimate is the total cost to
States in fiscal year 2017 to implement changes in the CCDBG Act?
Answer. In December 2015, HHS proposed revisions to the program
regulations to reflect the changes contained in the Child Care and
Development Block Grant Act of 2014. The Notice of Proposed
Rulemaking's regulatory impact analysis estimated the average annual
cost of full implementation at $1.1 billion. Of this total, only $5
million in costs stem from areas where HHS interpreted the statute and
proposed clarifications through regulation, including applying
background checks to regulated and registered child care providers and
non-caregivers. As you know, the child care program is supported by a
combination of Federal and State dollars, with, on average, 60 percent
of the funds coming from the Federal funding streams. The Department is
committed to supporting States through technical assistance and
additional resources as they implement the law's requirements.
______
Questions Submitted by Senator Jerry Moran
hrsa telehealth resource centers program
Question. What changes is HHS, specifically HRSA, considering to
the HRSA Telehealth Resource Centers program, which supports regional
Centers across the United States? If changes are being considered to
this program and/or current Centers, what steps are being taken by HHS
and HRSA to ensure the continuation of existing Centers and the
integral role they have in helping expand access to underserved
populations? Are there plans to maintain support for the current
Telehealth Resource Centers and ensure any updates to the program build
on important Federal investments already made to these important
Centers across the U.S.?
Answer. The fiscal year 2017 President's Budget includes $17
million for Telehealth Grants. The Telehealth program expands the use
of telecommunications technologies within rural areas that can link
rural health providers and patients with specialists to increase access
to, and the quality of, healthcare provided to rural populations. These
grants support the Improving Rural Health Care Initiative by
strengthening rural healthcare infrastructure. Of the $17 million
total, $4.6 million will be used to maintain support of regional
Telehealth Resource Centers, which provide technical assistance to
communities striving to establish or enhance and expand telehealth
services. HRSA does not plan to make major changes to the Telehealth
Resource Centers program in fiscal year 2017, as it will continue to
support the regional Centers.
______
Questions Submitted by Senator Thad Cochran
preventative health and health services block grant
Question. I am concerned about the proposed elimination of the
Preventative Health and Health Services Block Grant (PHHSBG). In
Mississippi, we use these funds to fluoridate water and to fund health
educators, among other things. What other resources at HHS would
provide these important activities such as fluoridation and health
educators if the PHHSBG is eliminated?
Answer. As you stated, the fiscal year 2017 Budget request
eliminates the Preventive Health and Health Services Block Grant
(PHHSBG). We believe these activities may be more effectively and
efficiently implemented through State and local chronic disease
funding, which provides resources to States to coordinate activities
across categorical funding streams. For example, the Centers for
Disease Control and Prevention's (CDC) has requested $18 million for
oral health programs to support fluoridation and other oral health
activities, continuing the $2.25 million increase appropriated in
fiscal year 2015. When the PHHSBG was first authorized in 1981, there
were minimal resources within CDC's budget allocated for categorical
programs such as heart disease, diabetes, oral health, immunizations,
and obesity, and many States did not receive funding from CDC to
support prevention of chronic disease. However, since 1981, categorical
programs at CDC have grown and can better address these public health
threats. Given the limited funding environment and our commitment to
investing in the highest-priority, evidence-based programs, elimination
of this program allows us to increase funding for key areas where CDC
can have the greatest impact, including combating antibiotic-resistant
bacteria and expanding the fight against opioid misuse, abuse, and
overdose.
mobilization for health: national prevention partnership awards program
Question. What types of programs were funded under the Mobilization
for Health: National Prevention Partnership Awards Program administered
by the Office of Assistant Secretary for Health? It is my understanding
that this particular program was last competed in fiscal year 2014.
What are the Department's plans for this program going forward?
Answer. The Office of the Assistant Secretary for Health (OASH)
made 13 grant awards in fiscal year 2014 through the Mobilization for
Health: National Prevention Partnership Awards (NPPA) Program. This
funding opportunity created a network of partnerships and resources to
promote health and wellness, educate and train, and establish
communication programs to all community populations, regardless of
social and economic barriers, race, and ethnicity. These awards are for
a 3 year project period
NPPA projects addressed an array of OASH priorities, including:
preventing teen pregnancy among Latino families by engaging community
health workers/promotores; improving access to preventive healthcare
services among limited English speaking families by strengthening links
among school, home and medical settings; and improving clinical
preventive services among the elderly by increasing the capacity of
existing networks of community-based health, service, and business
organizations.
OASH will continue to monitor and assess these projects to
determine future funding opportunities. We will keep your staff
updated.
dme reimbursement
I am concerned about the short timeframe that the Centers for
Medicare and Medicaid Services (CMS) has laid out for expanding
competitive bidding for durable medical equipment to rural areas. As
you know, my State of Mississippi is largely rural and, as a result,
Mississippians face many challenges in accessing healthcare. Why does
HHS believe that these competitive bidding rates, which will cut DME
reimbursement by 30 to 50 percent by July 1 of this year, will not
further impede access to quality healthcare for Americans living in
rural areas? What are CMS's plans, including the timeline, to collect
pertinent data to determine effects on access?
Answer. CMS has been using a real-time claims analysis to monitor
health status results in the DME competitive bidding program and other
Medicare payment systems. The analysis for the DME competitive bidding
program includes key indicators of the health status of beneficiaries
and their access to DMEPOS items and services such as deaths,
hospitalizations, emergency room visits, physician visits, admissions
to skilled nursing facilities, average number of days spent
hospitalized in a month, and average number of days in a skilled
nursing facility in a month. We also monitor beneficiaries who no
longer have claims for a competitively bid item after the program
began, beneficiaries who may at some point need the item, and
beneficiaries who currently have claims for competitively bid items.
CMS is doing a similar type of analysis and monitoring for the adjusted
DME fee schedule rates during the 6-month transition period and after
this transition period. In addition, CMS will be monitoring assignment
rates of suppliers. Assignment means that the suppliers have agreed to
accept Medicare allowed rate as full payment for the DME item. If there
are any issues identified through our monitoring, we will take
appropriate actions depending on the situation.
non-invasive positive pressure ventilation
Question. It is my understanding that the National Coverage
Determination (NCD) currently in place covers Non Invasive Positive
Pressure Ventilation (NIV) for patients with neuromuscular diseases,
restrictive thoracic diseases, and/or chronic respiratory failure
consequent to chronic obstructive pulmonary disease (COPD). CMS is
currently requiring that a patient be on NIV machine 24/7 in order to
for the NIV to be covered under Medicare. What is the medical
justification for this requirement? Is there medical benefit to NIV for
less than 24/7? Is CMS in violation of the NCD for patients with the
specified conditions?
Answer. A Medicare National Coverage Determination (NCD) is
developed by CMS to describe the circumstances for Medicare coverage
nationwide for an item or service. An NCD is binding on all Medicare
contractors in making determinations on Medicare claims and on
adjudicators during the Medicare claims appeal process. Under the NCD,
ventilators are covered for treatment of neuromuscular diseases,
thoracic restrictive diseases, or chronic respiratory failure
consequent to chronic obstructive pulmonary disease, including both
positive and negative pressure types. In making coverage
determinations, the Medicare contractors may consider criteria that
would account for the reasonable and necessary use of a ventilator in
order to avoid risk to the patient's health in a claim by claim
adjudication.
critical access hospitals
Question. It is my understanding that, during the process of
recertification, several CAHs in Mississippi have been asked to produce
the original letters they received when they originally obtained the
CAH status. This could be a substantial administrative burden on these
small rural hospitals, requiring many of them to comb through decades
of files. What is the justification for this requirement? Did CMS
consider the burden on CAHs when instituting this requirement? Will CMS
offer other alternatives to the original recertification letter?
Answer. Response: Thank you for your ongoing leadership on this
critical issue. I understand firsthand the challenges of healthcare in
rural America. Critical access hospitals provide valuable services to
Americans in rural areas, and we are committed to reducing
administrative burdens while meeting requirements outlined in statute.
Thank you for your ongoing leadership on this critical issue. I
understand the challenges of healthcare providers in rural America.
Critical access hospitals provide valuable services to Americans in
rural areas, and we are committed to reducing administrative burdens
while meeting requirements outlined in statute.
Section 1820(c)(2)(B) of the Social Security Act (the Act) requires
a Critical Access Hospital (CAH), other than a necessary provider CAH,
to be located in a rural area, more than a 35-mile drive (or 15 miles
in areas with only secondary roads or mountainous terrain) from a
hospital or another CAH. CMS regulations repeat this statutory
requirement.
The Office of Inspector General (OIG) report entitled, ``Most
Critical Access Hospitals Would Not Meet the Location Requirements if
Required to Re-enroll in Medicare,'' recommended that CMS periodically
reassess CAHs' compliance with all location-related requirements. CMS
concurred with the recommendation. Also consistent with OIG
recommendations, CMS determined to provide a 1 year transition period
for any CAH that would have its CAH status revoked due to such a
reassessment.
The OIG subsequently called on CMS to maintain evidence that it is
routinely re-evaluating the compliance of currently Medicare-certified
CAHs with these status and location requirements. In order to
facilitate this, CMS has developed the CAH Recertification Checklist:
Rural and Distance or Necessary Provider Verification for use by the
CMS Regional Office staff, which includes the requirement to retain the
original letter.
CMS Regional Offices use this checklist to determine if the CAH is
located outside the Metropolitan Statistical Area (MSA) by consulting
the OPM's latest MSA list. If the CAH had been certified as a Necessary
Provider, it is exempt from the distance requirements.
Question. Providers in my State have contacted me with their
concerns about how slow the Medicaid credentialing process is with
Managed Care Organizations (MCOs). Why can't MCOs accept a provider's
State Medicaid credentialing? Has CMS examined the whether MCOs take
too long in credentialing providers?
Answer. Credentialing is the process the managed care organizations
(MCOs) use to ensure that providers are qualified and meet the MCO's
quality standards for healthcare providers. CMS regulations require
States to establish a uniform credentialing and re-credentialing policy
that each MCO must follow. Nothing prohibits a State and the MCOs from
using a common credentialing process. CMS has not examined the length
of time that it takes MCOs to credential providers; MCOs' credentialing
process is an activity that falls within a State's normal contract
oversight.
long-term care hospitals
Question. The Senate report for the fiscal year 2016 appropriations
bill included the following language on page 149:
Severe Wounds.--The Committee directs the Secretary, in
consultation with relevant stakeholders, to conduct a study on
the treatment needs of individuals entitled to benefits under
part A, or enrolled under part B, of Medicare, requiring
specialized wound care, and the cost, for such individuals and
the Medicare program, of treating severe wounds in rural and
urban areas. The study shall include an assessment of: (A)
access of such individuals to appropriate levels of care for
such cases; (B) the potential impact that section
1886(m)(6)(A)(i) of the Social Security Act (42 U.S.C.
1395ww(m)(6)(A)(i)) will have on the access, quality, and cost
of care for such individuals; and (C) how to appropriately pay
for such care under the Medicare program. The Secretary shall
submit the report within 1 year after enactment of this act to
the Committees on Appropriations of the House of
Representatives and the Senate with recommendations for such
legislation and administrative actions as the Secretary
determines appropriate.
Madame Secretary, has HHS begun to prepare this report? If so, what
steps have been taken and what future steps have been identified?
Answer. HHS is reviewing the language, and will work to provide the
report as directed. We will share the report with you as soon as it is
completed.
physician shortages and graduate medical education in rural areas
Question. Mississippi faces physician shortages across the State,
particularly in our small towns and rural communities. Research has
shown that doctors most often practice in close proximity to where they
complete their residency training, yet across the Nation, our physician
residency slots are concentrated in metropolitan areas. What is HHS
doing to increase the number of resident physicians training in small
towns and rural communities? What role can Community Health Centers
(CHCs) play in addressing this challenge? What is HHS doing to build
the capacity for residency training within CHCs in our most rural
underserved areas?
Answer. HHS is committed to improving access to quality healthcare
for rural Americans, and to expanding and strengthening the health
workforce. The Budget provides a total of $1.3 billion for Health
Resources and Services Administration (HRSA) workforce programs,
including $715 million in mandatory funding to provide access to high-
quality healthcare professionals, particularly those living in areas
across the country with shortages of providers. This funding includes
investments in graduate medical education, the National Health Service
Corps, and workforce diversity efforts. By addressing the shortage of
primary care professionals that exists in certain parts of the country,
HRSA health workforce programs play a critical role in making sure all
Americans have access to high-quality healthcare.
As you suggest, rural training track residency programs are a
proven model for addressing rural physician workforce shortages. Rural
training track residency programs provide graduate medical education to
prepare resident physicians broadly for rural family medicine. As part
of our efforts to strengthen the health workforce and connect skilled
professionals to communities in need, HRSA operates two residency
training programs that train and place healthcare providers in
underserved areas across the Nation, including rural communities: the
Teaching Health Center Graduate Medical Education Program and the
Primary Care and Enhancement Program.
Teaching Health Center Graduate Medical Education Program
The Teaching Health Center Graduate Medical Education Program
provides funding for residency training in primary care medicine and
dentistry in community-based, patient caresettings. In addition to
increasing the number of primary care residents training in these
community-based patient care settings, the Teaching Health Center
Graduate Medical Education Program seeks to improve healthcare quality
and increase overall access to care, especially in rural and
underserved communities.
Since the program's inception, nearly all residents received
training in a medically underserved community, and just over 1 out of
every 5 received training in a rural area.
Of the 98 residents who completed the program in Academic Year
2014-2015, approximately 34 percent intended to practice in a medically
underserved area. This is an important programmatic accomplishment
toward increasing the numbers of those practicing in rural areas, since
physicians trained in rural areas tend to practice in rural areas.
In fiscal year 2014, the East Central Mississippi Health Network,
Inc. (EC-HealthNet), in Decatur, Mississippi, became a Teaching Health
Center Graduate Medical Education awardee. The purpose of the EC-
HealthNet Residency Consortium is to train physicians in rural areas to
increase the likelihood that they will 1) choose to practice in a rural
area and 2) have the clinical philosophy and skills to care for rural
residents. In fiscal year 2015, EC-HealthNet Residency Teaching Health
Center received $880,099 in Teaching Health Center Graduate Medical
Education funding to train 12 resident FTEs.
The fiscal year 2017 President's Budget includes $60 million in
already enacted mandatory funding in fiscal year 2017 and a request of
$527 million for fiscal year 2018 through fiscal year 2020 to support
876 residents, the currently approved number of residents in Teaching
Health Center Graduate Medical Education programs. The funding request
through fiscal year 2020 is critical for the sustainability of primary
care residency programs which require up to 3 to 4 years per resident
to complete training.
Primary Care Training and Enhancement Program
The Primary Care Training and Enhancement Program focuses on
training for transforming healthcare systems, and supports the clinical
training experience of trainees in rural and underserved areas, as well
as encourages interprofessional primary care education. In fiscal year
2015, 49 percent of our Primary Care Training and Enhancement grantees
were located in rural counties.
The fiscal year 2017 Budget requests $38.9 million for the Primary
Care Training and Enhancement Program to improve the quality of primary
care providers, increase the capacity of physician assistant education
programs, promote interprofessional practice, enhance medical education
through curriculum innovations and improve the distribution and
diversity of the healthcare workforce.
The Primary Care Training and Enhancement Program includes a
funding preference for applicants that demonstrate a high rate for
placing graduates/program completers in medically underserved
communities or a significant increase in the rate of placing graduates/
program completers in medically underserved community settings over the
preceding 2 years. Applicants receiving the preference are placed in a
more competitive position compared to other eligible applicants.
chronic pain
Question. People across the country suffer from chronic pain, and
there are some with pain so severe that opioid medication pills are no
longer effective for them or put them at risk for addiction or
diversion. For these patients, treatment with opioid medications via an
implanted infusion pump is often a good alternative for pain
management. These implanted infusion pumps slowly administer pain
medication solutions into a patient's intrathecal space to control pain
and reduce the need for opioid pain pills. CMS implemented Change
Request (CR) 7397 in 2013, despite feedback from patients, physicians,
and pharmacies across the country. This CR eliminated pharmacies'
ability to bill Medicare Part B for pain medication solutions used to
refill a patient's implanted infusion pump while in a doctor's office.
The change in policy contained in CR 7397 prohibits pharmacies from
billing Medicare for these solutions and requires that physicians ``buy
and bill'' these solutions in order for Medicare to cover them for
beneficiaries.
Are you aware that many State boards of pharmacy, including
Mississippi's, do not allow the practice of pharmacies selling
compounded solutions to physicians or other third parties for resale to
patients
In your opinion, would the use of intrathecal pain pumps reduce the
quantities of oral pain medication prescribed?
Patients across the country have lost and are losing access to this
treatment option since pharmacies can no longer bill Medicare directly
and cannot legally sell the compounded medications to physicians. Would
you be willing to publish a new Change Request implementing this
change?
Answer. HHS is committed to ensuring that the many Medicare
beneficiaries across the country that suffer from chronic pain have
access to the medications and treatments they need. In the Calendar
Year 2013 Medicare Physician Fee Schedule final rule, CMS clarified
longstanding policy that drugs used by a physician to refill an
implanted item of DME were considered to be ``incident to'' a
physician's services and not in the DME benefit category. Therefore,
for the drug to be paid under Part B, the physician must buy and bill
for the drug, and a non-physician supplier that has shipped the drug to
the physician's office may not bill CMS separately. It was our
understanding at the time the rule was written, that the majority of
pharmacies in the country were in compliance with the physicians' ``buy
and bill'' approach. We have not received reports that the situation
has changed, nor have we received reports of significant access
problems. CMS will continue to monitor this situation.
As additional background, in order to be covered by Medicare Part A
or Part B, an item or service must fall within one or more benefit
categories within such Parts, and must not be otherwise excluded from
coverage. Drugs and biologicals paid under Medicare Part B fall into
three basic categories:
--Drugs furnished ``incident to'' a physician's services. These are
typically injectable drugs that are bought by the physician,
administered in the physician's office, and then billed by the
physician to the Medicare Administrative Contractor (MAC). By
definition, ``incident to a physician's professional service''
requires the item or service to be billed by the physician.
--Drugs administered through a covered item of durable medical
equipment (DME). These drugs are supplies necessary for the
effective use of DME and are typically furnished to the
beneficiary by suppliers that are pharmacies (or general DME
suppliers that utilize licensed pharmacists) for administration
in a setting other than the physician's office. Most DME drugs
are billed to the DME MAC.
--Other drugs specified by the statute, including a variety of drugs,
such as certain oral immunosuppressives and vaccines.
--Depending on the circumstances, drugs used to refill an implanted
intrathecal pump can be paid under either ``incident to'' a
physician's services under Part B, under the DME benefit
category, or under Medicare Part D. We note that payment to
pharmacies (or suppliers) for drugs used to refill an implanted
pump can be made under the DME benefit category where the drug
is directly dispensed to a patient and the implanted pump is
refilled without a physician's service. However, it is our
understanding that implanted pumps are rarely refilled without
utilizing the service of a physician.
antibiotic resistance
Question. Language was included in the fiscal year 2016 Senate
report that highlights the significant effect of animal/human
interactions on antibiotic resistant bacteria. I believe our strategies
to combat antibiotic resistance must include both animals and humans.
What are your immediate plans to develop such an effort to stimulate
the synergy among academic medical centers and colleges of veterinary
medicine to advance the science related to antibiotic resistance?
Answer. I share your concern regarding the development of
antimicrobial-resistant bacteria and agree this is a critically
important public health issue. Over the past several years, HHS has
taken important steps toward fundamental change in how medically
important antibiotics can be legally used in feed or water for food
producing animals.
FDA is engaging in efforts to foster the advancement of education
and research focused on antimicrobial resistance. As an example, FDA
served in an advisory role to a task force that the Association of
American Veterinary Medical Colleges (AAVMC) and the Association of
Public and Land-grant Universities (APLU) formed to identify education
and research needs. FDA's Center for Veterinary Medicine is also
continuing to collaborate with AAVMC/APLU in the context of a working
group convened to develop core competencies related to antimicrobial
resistance for students at various levels. FDA believes that detecting
and controlling antibiotic-resistance requires the adoption of a ``One-
Health'' approach to disease surveillance that recognizes that
resistance can arise in humans, animals, and the environment.
Collaborations with academic organizations are of critical importance
for advancing good antibiotic stewardship principles that impact both
human and animal health.
community pharmacies
Question. It is my understanding that Medicare Part D prescription
drug plan sponsors may contract auditing of pharmacies to large
pharmacy companies like CVS Caremark. I am concerned that these
contracts may present a conflict of interest as a pharmacy chain's
parent company audits prescriptions filled by its competitors. Does CMS
approve these contracts, or are they purely at the discretion of the
Medicare Part D prescription drug plan sponsor? What CMS policies are
in place to ensure that there is no conflict of interest in these
auditing contracts?
Answer. The Part D regulations obligate Part D plan sponsors to
adopt and implement an effective compliance program, which must include
measures that prevent, detect, and correct a sponsor's non-compliance
with Part D program requirements as well as prevent and detect fraud,
waste, and abuse. A sponsor's compliance program must include a plan
for the performance of internal and external audits. In Chapter 9 of
the Medicare Prescription Drug Benefit Manual (``Compliance Program
Guidelines''), CMS provides guidance to sponsors on the effective
administration of their compliance plans, including the conduct of
audits. In particular, CMS instructs sponsors that they must ensure
that their auditors are independent and do not engage in self-policing.
Also, CMS instructs sponsors to develop a strategy for auditing their
first tier entities to make certain that such entities are monitoring
their downstream entities properly.
Many Part D sponsors contract with large pharmacy benefit managers
(PBMs) to perform, among other things, claims processing and network
contracting functions, on their behalf. In some instances, these PBMs
are the corporate relatives of large pharmacy chains. In these
arrangements, the PBMs are first tier entities to the Part D sponsor,
while the sponsor's network pharmacies are downstream entities to the
PBMs. Plan sponsors may also include in their PBM contracts provisions
requiring the PBM to audit the operations of the pharmacies
participating in the sponsor's Part D plans. CMS does not review or
approve these contracts.
Sponsors using their PBM to conduct their pharmacy audits are
responsible for ensuring that the PBM will conduct their audits in an
independent manner. Since sponsors remain accountable to CMS for their
compliance with all Part D requirements, it is in their interest to
ensure pharmacy audits provide the full picture of their contracted
pharmacy operations. Also, the Part D program's capitated payment
structure places the financial burden on the sponsors to scrutinize
closely the claims paid at all its contracted pharmacies, without
exceptions. Further, to comply with Part D program requirements
described above, sponsors need to conduct their own ``audit of the
auditor'' to confirm that the first tier auditing entity (e.g. the PBM)
is providing a fair account of the performance of downstream network
pharmacies. Finally, CMS, as part of its administration of the Part D
program, conducts audits of selected sponsors' Part D operations each
year, including a review of the audit strategies sponsors have
implemented to meet the compliance program requirement.
early childhood education
Question. The fiscal year 2017 budget request, in line with the
authorization included in the Every Student Succeeds Act (ESSA),
proposes to transition funding for the Preschool Development Grants
program from the Department of Education to the Department of Health
and Human Services. Can you provide more detail as to how this
transition will occur? How will the Department of Health and Human
Services work with the Department of Education to support high-quality
preschool programs?
Answer. The Department of Health and Human Services (HHS) and
Department of Education will continue to jointly administer the
Preschool Development Grants program in 2017 and beyond HHS has worked
closely with our colleagues at the Department of Education to ensure
that our programs are coordinated, serve our Nation's children as best
as possible, and create a continuum of high-quality early learning
services beginning at birth and continuing through age five.
The Departments have had success in the joint administration of
Race to the Top-Early Learning Challenge and Preschool Development
Grants in previous years and engage in numerous other activities to
ensure coordination at all levels. For example, the Departments co-
chair an Interagency Policy Board on Early Learning, that coordinates
policy, programs, research, and technical assistance across agencies
and issues joint policy statements on key issues, including the
inclusion of young children with disabilities in classrooms and
programs with typically developing peers and preventing and eliminating
the expulsion of young children from early childhood programs. Other
examples of collaboration include the joint development of Birth to
Five: Watch Me Thrive, which provides a toolkit to increase rates of
developmental screening and follow-up and dissemination of materials
highlighting how to utilize Medicaid to support creating school
environments with physical and mental health supports.
We appreciate the importance of close coordination in the joint
administration of the Preschool Development Grants Program, and will
continue to keep your staff updated as we proceed with planning and
implementation.
Question. The fiscal year 2017 budget requests $350,000,000 for
Preschool Development Block Grants, including $100,000,000 for new
awards. It is my understanding that these grants are intended to build
State and local capacity to implement preschool for underserved 4-year
olds. What steps does the Department plan to take to ensure that
funding awarded through Preschool Development Block Grants is awarded
to States where Federal support for early childhood education can meet
the needs of rural, minority, and low-income students?
Answer. The creation of the Preschool Development Grants program in
2014, consistent with the President's Preschool for All mandatory
proposal, provides funding to States to build and expand high-quality
preschool for children from low- and moderate-income families in a
mixed delivery system of providers. This mixed delivery includes
schools, licensed child care centers, Head Start, or other community-
based organizations prepare low-income and disadvantaged children to
enter kindergarten.
The fiscal year 2017 request would allow HHS to work with the
Department of Education to issue 18 continuation grants for the fourth
and final year of the existing initiative, which enables existing
Preschool Development Grant grantees to continue building and expanding
preschool in their States. Working in over 200 high need communities,
the current grantees have demonstrated tremendous success in building
the fundamental components of a high quality preschool system and
expanding high quality preschool models. For example, Arizona is
providing early childhood mental health consultation and intervention
as part of the comprehensive supports to Preschool Development Grant-
funded programs, which are located in high-need communities. The
increase in 2017 will allow for new grants under the ESSA to improve
the overall quality of preschool programs while improving coordination
across early learning systems and increasing parent choice and
knowledge about these programs.
The PDG expansion is one of several efforts the Budget supports to
expand access to high quality early learning to children in underserved
communities. The fiscal year 2017 Budget also includes an increase of
approximately $200 million for the Child Care and Development Block
Grant (CCDBG), including $160 million to support implementation of the
changes required by the recent bipartisan reauthorization and $40
million to test innovative strategies to address the child care needs
of working families, such as care during non-traditional hours and in
rural areas. Increases are also requested in Head Start and Home
Visiting.
______
Questions Submitted by Senator Lamar Alexander
interdepartmental review of early learning programs
Question. On November 19, 2014, the President signed the Child Care
and Development Block Grant Act into law. This law required the
Secretary of Health and Human Services to conduct, within 1 year of
enactment, an interdepartmental review of all early learning and care
programs to identify overlapping programs and make recommendations to
Congress for elimination and consolidation. We are nearly 3 months past
the mandated deadline of this report. When does the Department plan to
issue this report?
Answer. The Departments are currently in the process of finalizing
the joint report and are working to get the completed report to
Congress. The Departments will provide the joint report to Congress as
soon as the process is complete.
child care and development block grant vouchers
Question. The Child Care and Development Block Grant (CCDBG) Act
stipulates that nothing shall ``favor or promote the use of grants and
contracts for the receipt of child care services under this subchapter
over the use of child care certificates.'' Report language reinforces
Congressional intent that the primary goal of CCDBG is to promote
parental choice through the use of vouchers. Any requirements through
regulations to mandate States to use grants and contracts, in any
capacity, interferes with a State's ability to maintain the use of
vouchers. As your department continues to develop proposed regulations
for the Child Care and Development block grant, how do you intend to
maintain the use of vouchers, as well as State discretionary authority
to decide how and when to use grants and contracts to deliver services?
Answer. We agree that parental choice is important to the Child
Care and Development Block Grant (CCDGB) program and the families it
serves. Under the December 2015 Notice of Proposed Rulemaking, States
must continue to offer every family receiving a subsidy the option to
use a certificate/voucher. The proposal did not require the option of a
grant- or contract-funded slot for every family, rather each State
would determine the extent to which it will use grants and contracts.
We believe that parents are in the best position to choose the care
that best fits their families' needs. Child care certificates (or
vouchers) are important because they give parents the opportunity to
select from a range of child care options.
Some communities lack an adequate supply of child care providers,
particularly of high-quality providers, and particularly for certain
types of care, such as infant and toddler care. A lack of supply limits
parent choice because there are simply no quality providers from which
to choose. For example, the National Survey of Early Care and Education
found that while 89 percent of centers served 4-year old children, only
36 percent of centers served babies less than a year old. Without an
adequate supply of providers, a certificate or voucher is ineffective
because a family cannot use it. The 2014 bipartisan reauthorization of
the CCDBG Act recognized this problem by including important supply-
building provisions. Where States have used grants and contracts in a
targeted manner, they have helped stabilize the supply and quality of
care for specified populations of children.
In our December 2015 Notice of Proposed Rulemaking, we proposed
that every State make some use of grants and contracts, with the extent
of use determined by the State, in order to address supply gaps for
high-quality care in communities. We are currently reviewing public
comments received in response to this proposal will give the comments
careful consideration as we develop the final rule.
preschool development grants program
Question. As part of the Every Student Succeeds Act, Congress
authorized a new Preschool Development Grants program to be jointly
administered by the Department of Health and Human Services and the
Department of Education. How do you intend to preserve the
Congressional intent outlined in the program purposes, which call for
collaboration and coordination among existing programs and new
partnerships in order to maximize parental choice in a mixed delivery
system of early childhood education programs? How will you promote the
continuation of coordination efforts past the initial planning year
through the lifetime of the grant and beyond?
Answer. Consistent with the statute, the purpose of the Preschool
Development Grants program is to coordinate early childhood education
programs in a mixed delivery system of providers including schools,
licensed child care centers, Head Start, or other community-based
organizations that will prepare low-income and disadvantaged children
to enter kindergarten and to improve the participation of children in
high-quality programs in this system. These goals are consistent with
our efforts to align all early learning programs and ensure a continuum
of services for children birth to school entry. We are working
collaboratively with the Department of Education to ensure that the
purposes as defined in the statute are clearly articulated and promote
coordination beyond the initial planning year through the lifetime of
the grant and beyond. Although we are early in the process, we are
working to identify how these goals and principles will be articulated.
Additionally, we are working to ensure that we remove any barriers for
States to implement and provide services through a mixed-delivery
system and through better alignment of policies and regulations that
cross the departments and funding sources.
fda generic drugs
Question. On November 13, 2013 the FDA released a proposed rule
that would require generic drug manufacturers to make unilateral
changes to the labels for generic drugs, even if the manufacturer of
the corresponding brand name drug has not implemented the same labeling
change. If finalized, this rule would impose new regulatory burdens and
potentially expose generic drugmakers to significant new State law tort
liability.
The President's fiscal year 2017 budget request includes several
proposals that, according to the Administration, would ``address the
rising cost of pharmaceuticals.'' At the same time, the proposed
generic labeling rule imposes significant new burdens that could be
passed on to consumers in the form of higher drug prices. By some
estimates, the rule could increase spending on generic drugs by as much
as $4 billion, $1.5 billion of which would be borne by taxpayers
through government healthcare spending. In contrast, the cost estimate
in the proposed rule States that it is expected to generate little
cost.
Given the potential impact on consumers and taxpayers, it is
critical that we have an accurate cost estimate. Please describe the
process by which the Department of Health and Human Services analyzes
the economic impact of new requirements, including a description of
which factors are and are not considered as part of that analysis.
Please also explain why the cost estimate included in the proposed
generic labeling rule is billions of dollars less than other cost
estimates, and describe whether and how the Department is considering
revisions to its prior estimate.
Answer. The proposed rule is intended to improve the communication
of important drug safety information to healthcare professionals and
patients. FDA has received a great deal of public input from
stakeholders during the comment period on the proposed rule regarding
the best way to accomplish this important public health objective.
FDA is carefully considering comments submitted to the public
docket established for the proposed rule from a diverse group of
stakeholders including: consumers and consumer groups, academia
(including economists), healthcare associations, drug and pharmacy
associations, brand and generic drug companies, law firms, State
governments, and Congress, including comments proposing alternative
approaches to communicating newly acquired safety-related information
in a multi-source environment (see Docket No. FDA-2013-N-0500). These
comments include a summary of FDA's meeting with the Generic
Pharmaceutical Association (GPhA) on September 8, 2014, to listen to
their comments and views regarding the proposed rule. In addition, FDA
held a public meeting on March 27, 2015, at which any stakeholder had
the opportunity to present or comment on the proposed rule, or on any
alternative proposals intended to improve communication of important,
newly acquired drug safety information to healthcare professionals and
the public. In the February 18, 2015, notice announcing the public
meeting, FDA reopened the docket for the proposed rule until April 27,
2015, to allow the submissions of written comments concerning proposals
advanced during the public meeting. FDA will determine next steps based
on our analysis of comments on the proposed rule and additional
information submitted as part of the public meeting.
Any final rule that is adopted will reflect FDA's consideration of
public comments, including the varying perspectives related to the
potential economic impact, and would be accompanied by an analysis of
the economic impact of the regulatory change described in the final
rule. This regulatory impact analysis would be based on the framework
described in Executive Orders 12866 and 13563, and use the best
available techniques to quantify anticipated present and future
benefits and costs. The regulatory impact analysis would help ensure
that any regulation is adopted only upon a reasoned determination that
its benefits justify its costs, and is tailored to impose the least
burden on society, consistent with obtaining regulatory objectives.
fda budget authority for medical products
Question. I am disappointed that the President's budget request for
the Food and Drug Administration does not acknowledge the exciting time
in science by requesting a meaningful increase in budget authority for
medical products. An additional $25 million was requested this year
after the $104 million in additional funds was provided to the agency
last year for food safety activities, while an increase of only $3.196
million was requested for medical product safety and availability. FDA
involvement in patient focused drug development, next generation
sequencing, and biomarkers is integral to Precision Medicine and the
Cancer Moonshot Initiatives. Can you explain?
Answer. The President's Budget requests $2.8 billion for Medical
Product Safety, an increase of $116 million when accounting for all
resources above fiscal year 2016 enacted levels, and includes $75
million in new mandatory funding for the Vice President's Cancer
Moonshot. Patient focused drug development, next generation sequencing,
and biomarkers continue to be important priorities to FDA. The request
considered various priorities when deciding on the requested increase
for medical product safety and availability.
______
Questions Submitted by Senator Mark Kirk
smart card technology
Question. In several meetings, you and I have discussed the
potential for smart card technology to reduce administrative
procedures, eliminate fraudulent spending, and protect identity in
healthcare spending, specifically in Medicare. You conveyed your
support for broadly addressing this very issue across all agencies from
your previous post at OMB. Recent GAO reports support the use of smart
cards for identity protection and recovering improper payments.
Please name which programs within HHS that would benefit from this
technology and how they would benefit.
Answer. MACRA directed HHS to review the cost effectiveness and
technological viability of use electronic Medicare beneficiary and
provider cards (such as cards that use smart card technology, including
an embedded and secure integrated circuit chip), as presented in the
Government Accountability Office report required by the conference
report accompanying the Consolidated Appropriations Act, 2014 (Public
Law 113--76). This work is currently underway. Given that analysis is
still underway for Medicare, we have not at this time determined how
this technology would be viable or benefit other HHS programs.
Question. If a pilot program could be conducted to demonstrate the
effectiveness of the smart card technology, what would the structure of
the pilot look like?
Answer. MACRA directed HHS to review the cost effectiveness and
technological viability of using electronic Medicare beneficiary and
provider cards (such as cards that use smart card technology, including
an embedded and secure integrated circuit chip), as presented in the
Government Accountability Office report required by the conference
report accompanying the Consolidated Appropriations Act, 2014 (Public
Law 113--76). This work is currently underway.
In 2011 and 2012, CMS conducted a pilot program in which physicians
and suppliers were issued electronically readable cards that they
swiped when referring or fulfilling medical supply orders. When swiping
the cards, they entered the last four digits of the beneficiary's
Medicare number into credit card readers. CMS used information from the
card transactions, including the date and beneficiary Medicare numbers,
to match the transactions to submitted claims. The pilot only studied
the ability to match card transactions with submitted claims, and did
not involve any changes to claims processing systems or the
adjudication process.\2\
---------------------------------------------------------------------------
\2\ From March 2015 GAO report Potential Uses of Electronically
Readable Cards for Beneficiaries and Providers.
---------------------------------------------------------------------------
As a result of the pilot program, CMS found that many providers
could not participate in the program because they did not have access
to the necessary technology. Further, CMS was unable to assess any
program integrity effect from use of the cards due to low provider
participation in the pilot.
Question. Specifically within the Centers for Medicare and Medicaid
Services (CMS), could smart card technology reduce improper payments in
outpatient billing in Medicare Parts A, B, C, or D?
Answer. The GAO recently found that the use of smart cards could
have affected about 22 percent (165 cases) of cases GAO reviewed in
which the entire or part of the case could have been affected because
they included schemes that involved the lack of verification of the
beneficiary or provider at the point of care. However, in the majority
of cases (78 percent), smart card use likely would not have affected
the cases because either beneficiaries or providers were complicit in
the schemes, or for other reasons. For example, the use of cards would
not have affected cases in which the provider misrepresented the
service (as in billing for services not medically necessary), or when
the beneficiary and provider were not directly involved in the scheme
(as in illegal marketing of prescription drugs).
In these instances, the schemes would not have been affected by the
smart cards because although the beneficiary and provider were present
at the point of care, the provider misrepresented the services rendered
after the smart cards would have registered their identities. These
schemes included the following:
--billing for services that were not provided along with services
that were provided legitimately,
--billing for services that were not medically necessary,
--upcoding,
--unbundling of services,
--billing for services that were not prescribed or not referred by a
physician, and
--billing for services as if they were provided by a physician to
receive a higher payment rate when they were actually provided
by another provider in which the payment rate would have been
lower.
In these schemes, smart cards would not be able to detect that the
provider misrepresented the actual services provided even if the cards
verified the beneficiary's and provider's presence. Similarly, schemes
that involved a provider misrepresenting eligibility to provide
services would not have been affected by smart cards, including schemes
in which bills were submitted for services provided by an excluded
provider or by an unlicensed, uncertified, or ineligible provider. Many
of these schemes involved healthcare entities that billed for services
provided by employees or contractors that were not licensed or were
excluded from providing care.\3\
---------------------------------------------------------------------------
\3\ From Jan 2016 GAO report Information on Most Common Schemes and
the Likely Effect of Smart Cards.
---------------------------------------------------------------------------
Medicare Advantage organizations and Prescription Drug Plan
sponsors issue cards directly to their enrollees.
Question. Similarly, could smart card technology reduce duplicative
procedures and duplicative or fraudulent spending in Medicare Parts A
and B combined?
Answer. The GAO recently found that using electronically readable
cards to authenticate beneficiary and provider presence at the point of
care could potentially limit certain types of Medicare fraud. However,
the GAO could not determine the extent to which authenticating
beneficiaries and providers at the point of care could limit fraud
because there is no reliable estimate of the extent or total dollar
value associated with specific types of Medicare fraud schemes.
According to the GAO, use of the cards would not prevent providers
from mischaracterizing services, billing for medically unnecessary
services, or adding a service that was not provided to a claim for
otherwise legitimate services because such fraud does not involve
issues related to authentication. Instead, these types of fraud
typically involve providers that wrongly bill Medicare for the care
provided, or misrepresent the level or nature of the care provided. The
use of electronically readable beneficiary and provider cards would
also have little effect on preventing fraud that involves collusion
between providers and beneficiaries because complicit beneficiaries,
including those who receive kickbacks, would likely allow their cards
to be misused.\4\
---------------------------------------------------------------------------
\4\ From Jan 2016 GAO report Information on Most Common Schemes and
the Likely Effect of Smart Cards.
---------------------------------------------------------------------------
Question. What about its effectiveness in Medicare Advantage?
Answer. As noted above, Medicare Advantage organizations issue
cards directly to their enrollees. The GAO has noted that Medicare
beneficiaries who enroll in Part C or Part D plans receive separate
cards from those plans, in addition to their traditional Medicare card.
Question. Which parts of Medicare could CMS conduct a pilot in that
includes insurers already utilizing smart card technology, thereby
reducing burden on CMS?
Answer. CMS regularly works in partnership with insurers and is
frequently interested in exploring ways to work with the private sector
to reduce waste, fraud and abuse. For example, the Healthcare Fraud
Prevention Partnership (HFPP) is a voluntary public-private partnership
between the Federal Government, State officials, law enforcement,
private health insurance plans and associations, and healthcare anti-
fraud associations.
______
Questions Submitted by Senator Shelley Moore Capito
fda labeling for anda rule
Question. In 2013 the FDA released a proposed rule on labeling
changes for ANDA holders. This proposed rule, titled Supplemental
Applications Proposing Labeling Changes for Approved Drugs and
Biological Products, Docket No. FDA-2013-N-0500, has not yet been
finalized. Have you made a determination whether you are going to move
forward with this rule?
Answer. The proposed rule is intended to improve the communication
of important drug safety information to healthcare professionals and
patients. FDA has received a great deal of public input from
stakeholders during the comment period on the proposed rule regarding
the best way to accomplish this important public health objective.
FDA is carefully considering comments submitted to the public
docket established for the proposed rule from a diverse group of
stakeholders including: consumers and consumer groups, academia
(including economists), healthcare associations, drug and pharmacy
associations, brand and generic drug companies, law firms, State
governments, and Congress, including comments proposing alternative
approaches to communicating newly acquired safety-related information
in a multi-source environment (see Docket No. FDA-2013-N-0500). These
comments include a summary of FDA's meeting with the Generic
Pharmaceutical Association (GPhA) on September 8, 2014, to listen to
their comments and views regarding the proposed rule. In addition, FDA
held a public meeting on March 27, 2015, at which any stakeholder had
the opportunity to present or comment on the proposed rule, or on any
alternative proposals intended to improve communication of important,
newly acquired drug safety information to healthcare professionals and
the public. In the February 18, 2015, notice announcing the public
meeting, FDA reopened the docket for the proposed rule until April 27,
2015, to allow the submissions of written comments concerning proposals
advanced during the public meeting. FDA will determine next steps based
on our analysis of comments on the proposed rule and additional
information submitted as part of the public meeting.
The Unified Agenda, available at http://www.reginfo.gov/public/do/
eAgenda
ViewRule?pubId=201510&RIN=0910-AG94 currently lists an anticipated
publication date of July 2016 for the final rule. The dates for rules
in the Unified Agenda are projected dates that may be adjusted to
reflect ongoing work on specific rules.
Question. Is there evidence that the current reporting requirements
are not being complied with by generic drug manufacturers or that they
are inadequate?
Answer. The proposed rule focuses on the obligation to update
labeling to reflect newly acquired information, not on the legal duties
to report adverse drug events to FDA or more generally to meet post-
market surveillance requirements associated with adverse event
reporting obligations. The proposed rule neither cites nor is based on
evidence that generic drug manufacturers are not submitting to FDA
required reports of spontaneous adverse event reports that they
receive.
Question. Has the FDA estimated the impact the rule could have on
prescription drug costs and access? If so, what is the impact?
Answer. The proposed rule is intended to improve the communication
of important drug safety information to healthcare professionals and
patients. FDA has received a great deal of public input from
stakeholders during the comment period on the proposed rule regarding
the best way to accomplish this important public health objective.
FDA is carefully considering comments submitted to the public
docket established for the proposed rule from a diverse group of
stakeholders including: consumers and consumer groups, academia
(including economists), healthcare associations, drug and pharmacy
associations, brand and generic drug companies, law firms, State
governments, and Congress, including comments proposing alternative
approaches to communicating newly acquired safety-related information
in a multi-source environment. These comments include a summary of
FDA's meeting with the Generic Pharmaceutical Association (GPhA) in
September 2014, to listen to their comments and views regarding the
proposed rule. In addition, FDA held a public meeting in March 2015, at
which any stakeholder had the opportunity to present or comment on the
proposed rule, or on any alternative proposals intended to improve
communication of important, newly acquired drug safety information to
healthcare professionals and the public. In the February 18, 2015
notice announcing the public meeting, FDA reopened the docket for the
proposed rule until April 27, 2015, to allow the submissions of written
comments concerning proposals advanced during the public meeting. FDA
will determine next steps based on our analysis of comments on the
proposed rule and additional information submitted as part of the
public meeting.
Any final rule that is adopted will reflect FDA's consideration of
public comments and would be accompanied by an analysis of the economic
impact of the regulatory change described in the final rule. This
regulatory impact analysis would be based on the framework described in
Executive Orders 12866 and 13563, and use the best available techniques
to quantify anticipated present and future benefits and costs. The
regulatory impact analysis would help ensure that any regulation is
adopted only upon a reasoned determination that its benefits justify
its costs, and is tailored to impose the least burden on society,
consistent with obtaining regulatory objectives.
______
Questions Submitted by Senator Jack Reed
liheap program
Question. Access to affordable home energy is a matter of health
and safety for many low-income households, children, and seniors.
Unfortunately, the average LIHEAP grant has declined over the last few
years and now covers just a fraction of average home energy costs,
leaving many low-income families and seniors with fewer resources
available to meet other basic needs. There remains a significant gap
between the need and the funding.
What are the reasons why LIHEAP doesn't rate more highly among HHS
priorities? How will HHS continue its commitment to providing our most
vulnerable populations with vital home energy assistance?
Answer. The budget proposes to fund LIHEAP through a combination of
discretionary funds ($3 billion) and a proposed mandatory funding
trigger providing additional resources in response to energy price
spikes, increases in eligibility, and extreme cold at the beginning of
winter ($769 million based on a probabilistic score). Total resources
of $3.8 billion are requested, an increase of $379 million over fiscal
year 2016.
Question. Congress provided $3.39 billion for LIHEAP; however, only
$3.02 billion has been released to date. This means approximately $372
million has not yet been released for its intended purpose, to provide
home energy assistance to the most vulnerable households in the
country.
What is the Department's plan for these funds? When can we expect
to see the $372 million released to States under the LIHEAP formula?
Answer. HHS expects to make another release of LIHEAP funding in
the near future. We will keep your staff updated as that occurs.
cdc healthy homes lead poisoning prevention program
Question. As you know, I have been advocating for the full
restoration of CDC's healthy homes/lead poisoning prevention program
for many years. Almost 5 years ago, this program was nearly eliminated
and since then I have been working with my colleagues to restore the
funding. Given the situation in Flint, Michigan, I was disappointed
that the President's budget request only flat funded the CDC program,
given the considerable need. It seems to me that this is one program we
would want to increase this year.
How will we be able to effectively prevent situations like Flint if
some States still don't have lead poisoning prevention programs?
Answer. The recent events in Flint have highlighted the continued
risk that lead poisoning presents to communities and children. CDC
currently funds 29 States, Washington D.C., and five other cities
through a lead poisoning prevention cooperative agreement. The
cooperative agreement focuses on reducing children's blood lead levels
through surveillance and primary prevention. These awards support
grantees to:
--Implement and/or improve lead surveillance systems and data
collection; and
--Increase the use of surveillance data to guide population-based
prevention strategies (e.g., housing rehabilitation,
enforcement of housing and health codes, and early childhood
and other educational activities).
These surveillance data can help grantees and other partners target
testing and resources to the highest-risk children as well as identify
and address emerging sources of exposure.
However, most unfunded States are unable to collect lead
surveillance data and/or report it to CDC. Without such data, States
and cities are unable to target resources towards those with the
greatest need or identify and address areas of concern. We would like
to work with Congress to help ensure that States have the support
needed to prevent lead poisoning.
Regarding the Flint water crisis specifically, the Federal response
in place is supporting State and local leaders identify the size and
scope of the problem, and to make and execute a plan for mitigation of
the short- and long-term health effects of lead exposure. Specific
activities include:
--HHS has deployed a total of 24 Commissioned Corps officers in
support of eight distinct mission elements of the Public Health
Assistance and Support Team, including mental health support,
psychological first aid training focusing on schools and faith
entities, and behavioral health support for community-based
health and human services providers.
--On March 3, the Centers for Medicare & Medicaid Services (CMS)
approved the State of Michigan's 1115 demonstration to extend
Medicaid coverage and services to Flint, Michigan residents
impacted by the lead exposure. Approximately 15,000 additional
children and pregnant women will be eligible for Medicaid
coverage and 30,000 current Medicaid beneficiaries in the area
will be eligible for expanded services under this new waiver
agreement. Additionally, we are working with the State to
design and expeditiously process an alternative option through
a targeted and time-limited health services initiative under
title XXI of the Social Security Act for abatement activities
that would complement other State and local efforts to remove
lead hazards from the homes of Medicaid and CHIP eligible
children and pregnant women.
--HHS awarded $500,000 in emergency supplemental funding to Hamilton
Community Health Network, Inc. and Genesee Health System,
Health Resources and Services Administration (HRSA)-funded
health centers, to hire additional personnel and provide more
lead testing, treatment, outreach, and education to meet the
increased need for health services in the Flint community.
--ASPR is using existing resources to help State health officials
identify vulnerable populations in Flint who may need further
targeted outreach and assistance.
--The Administration for Children and Families (ACF) and HRSA
continue working with their grantees in the area to disseminate
public health education through Head Start, Community Health
Centers, and other programs to help families understand the
risks of lead in the water. ACF and HRSA are working to
leverage Medicaid to ensure that children and pregnant women
have access to services to assist in treating exposure to lead.
--The Disaster Distress Helpline, sponsored by the Substance Abuse
and Mental Health Services Administration (SAMHSA), is
available to provide crisis counseling and support to people--
including children and families in Flint--who are experiencing
emotional distress related to natural or human-caused
disasters.
--The Centers for Disease Control and Prevention (CDC)'s Agency for
Toxic Substances and Disease Registry (ATSDR) is providing
technical assistance to the State on lead exposure, water
sampling protocols, and home inspections. ATSDR is working with
the State to determine the number of children exposed to lead
in Flint to ensure that children who should be screened are
getting screened. After a formal request from the State to
investigate rashes and other skin concerns affecting Flint
residents, a team of experts from CDC and ATSDR began an
Assessment of Chemical Exposure investigation on February 22.
--The Food and Drug Administration (FDA)'s Detroit District Office
assessed potential impacts on FDA-regulated industries in the
Flint area, including human food and animal feed production. No
impacts were found, and FDA continues to assess and monitor the
situation.
--The National Institutes of Health (NIH)/National Institute of
Environmental Health Sciences (NIEHS) has an expedited process
for reviewing research proposals and funding grants to address
environmental emergencies, such as the lead-contaminated water
crisis in Flint. The NIEHS is soliciting these research
proposals now. Additionally, the new NIH Disaster Research
Response initiative is working to improve research tools,
protocols, and training necessary to conduct time-critical
health research in response to disasters, which can be found at
http://dr2.nlm.nih.gov/.
access to naloxone
Question. While the Senate recently passed legislation to help
prevent drug overdoses and expand access to treatment, more needs to be
done, particularly to ensure new funding is made available immediately
for these efforts. I have introduced legislation to provide communities
access to naloxone--the overdose reversal drug--to prevent deaths and
help move people into treatment options.
What is HHS doing to expand access to naloxone and to help prevent
overdose deaths?
Answer. In March 2015, I announced the Department's plan for
combatting opioid misuse, abuse, and overdose deaths, which includes a
set of targeted strategies focused on stemming the rise in opioid-
related mortality and morbidity. One of the three priority areas of my
plan is promoting the use of naloxone.
I am grateful for the $12 million the Congress provided in fiscal
year 2016 for the Substance Abuse and Mental Health Services
Administration for grants to States to purchase naloxone, equip first
responders in high-risk communities, and provide education and other
materials to assemble and disseminate overdose kits. This funding and
training support aims to allow States to target resources where it is
most needed in their communities. The fiscal year 2017 President's
Budget includes $12 million, the same level as fiscal year 2016, to
continue support for this critical activity.
I also thank you for the $1.8 million the Congress provided in
fiscal year 2015 to support rural communities in reducing morbidity and
mortality related to opioid overdoses through the Health Resources and
Services Administration's Rural Opioid Overdose Reversal Grant Program.
These awards were announced on September 17, 2015 to purchase naloxone,
and training for its use by licensed healthcare professionals and
emergency responders in rural areas. The fiscal year 2017 President's
Budget requests an additional $10 million to support these activities,
increasing the number of rural communities that will be served, and
placing a stronger emphasis on prevention, education, referral and
treatment.
Further, HHS also continues to make progress in several other areas
that will promote the use of naloxone. This past July, the Food and
Drug Administration, in collaboration with other HHS agency partners,
held a scientific workshop to initiate a public discussion about issues
surrounding the uptake of naloxone in a variety of medical and non-
medical settings to reduce the incidence of opioid overdose fatalities.
FDA continues to make naloxone a priority, having approved, on an
expedited timeframe, both an auto-injector and an intranasal
formulation. Both of these products are designed for use by lay
bystanders, as well as first responders. FDA continues to explore
alternative methods for making naloxone more available.
HHS has also held two national meetings since 2014 where States
were able to collaborate with one another to develop and share best
practices for interventions to address the opioid epidemic, including
those related to naloxone dissemination and utilization.
______
Questions Submitted by Senator Jeanne Shaheen
zika supplemental
Question. Unfortunately, New Hampshire had the State's first
confirmed case of Zika this week. An adult female contracted the virus
after sexual contact with a male who was symptomatic and had traveled
to a country where Zika virus transmission is occurring. Thankfully,
the patient has fully recovered and is not pregnant.
I know that the Administration is seeking a $1.9 billion Zika
supplemental to combat the spread of Zika.
What funding sources does HHS currently have to work immediately on
the Zika issue while we deliberate the supplemental funding?
Answer. HHS is supporting Zika efforts through reprioritization of
existing funding resources, including reprogramming fiscal year 2016
funding for CDC's Public Health Emergency Preparedness program,
transfer from CDC's fiscal year 2016 funding for the Strategic National
Stockpile, and repurposing of prior-year balances from the Prevention
and Public Health Fund. This funding will enable HHS to respond to
urgent needs in the short-term; however this funding approach will not
be sustainable and emergency funding, as requested, will be necessary
for an effective response. To minimize the impact of the reallocations
noted above, the Administration's emergency supplemental appropriations
request includes a provision which would allow funds to reimburse HHS
accounts for activities supporting Zika disease response that occurred
prior to enactment. This authority is critical to maintain our
preparedness and response capabilities.
Question. What funds are available to help States address Zika,
particularly to help with State public health laboratory testing
capabilities and protocols?
Answer. CDC is working with health departments across the country
to ensure coordination and to expand capacity for detecting and
responding to Zika virus. Surveillance is essential to monitor and
quickly identify areas with mosquito-borne (local) Zika transmission.
This includes multi-faceted surveillance for arboviruses, including
Zika, through ArboNET, an integrated network which funds staff in 49
States, Puerto Rico, and six large municipalities to conduct human case
investigations, collect and test mosquitos, and perform laboratory
analysis on arboviruses including Zika. Zika virus is now a nationally
notifiable disease, meaning States report the virus to CDC, which will
aid Zika surveillance efforts. CDC is also working with several States
and Puerto Rico to determine a baseline prevalence of microcephaly so
that any increase, should it occur, can be quickly and accurately
identified.
Additional funding, as requested in the Administration's emergency
supplemental appropriations request, will be essential to supporting
CDC's expansion of efforts to provide financial and technical resources
to States and territories to strengthen their capacity to prepare for
and respond to emerging insect-borne threats such as Zika virus. These
resources will be used to help health departments expand their
capability to manage cases of local Zika virus transmission in their
areas and to implement community education and prevention programs to
reduce human-mosquito contact and subsequently, the risk of Zika
transmission. Resources will also be used to implement mosquito control
strategies, including mosquito surveillance. Current mosquito
surveillance capacity is uneven across the country, which makes our
knowledge about the locations of the two mosquito vectors that transmit
Zika virus potentially incomplete. To effectively track the spread of
the outbreak, it is critical that States and territories receive
specimens and test for Zika virus to diagnose and report travel-related
and locally acquired cases of Zika. Under the supplemental request CDC
will expand its efforts to assist public health labs nationwide with
the tools necessary to test for Zika and to provide guidance on how to
interpret test results.
CDC is also currently distributing testing kits so that more health
departments have the proficiency to perform testing, but will need to
increase the existing capacity to meet the projected demand for Zika
testing. Given that, last year, it is estimated that over 500,000
travelers to areas of current Zika transmission were pregnant women and
36,000 pregnant women are currently living in Puerto Rico, the
expansion of testing capacity in public health labs nationwide,
included in the request, is urgently needed in order to ensure that
every pregnant woman needing testing for Zika virus has access.
Question. How are you coordinating with other agencies working on
Zika, and with other countries who are experiencing an outbreak?
Answer. CDC is working in collaboration with other components of
the Department of Health and Human Services (HHS), including the Office
of the Assistant Secretary for Preparedness and Response (ASPR) and the
Biomedical Advanced Research and Development Authority (BARDA), the
National Institutes of Health, and the Food and Drug Administration. In
addition, HHS is working with partners across the U.S. Government to
communicate with travelers and healthcare providers; update travel
alerts and clinical guidance; and develop improved mosquito-control
methods.
Through the Office of Global Affairs and CDC, HHS is also
coordinating its response with the Pan American Health Organization
(PAHO), the regional body of the World Health Organization (WHO), with
other parts of WHO, and is collaborating with many international
partners to learn more about this outbreak. ASPR and OGA also lead our
efforts with the Global Health Security Initiative, a partnership with
Canada, France, Germany, Italy, Japan, Mexico, the United Kingdom, the
United States and the European Commission. CDC is also working with the
Brazilian Ministry of Health on investigation and research
partnerships. Research teams from CDC are also in other countries,
including Colombia, to explore collaborations that will shed light on
the risk of microcephaly in relation to Zika virus infection during
pregnancy.
In addition, CDC is offering support to all countries so that they
can test samples from microcephaly cases for serologic evidence of Zika
virus infection, and CDC is helping countries throughout the Americas
establish in-country diagnostic capacity. To that end, we are
currently, in conjunction with the PAHO, providing training to
laboratorians in South and Central America on diagnostic tests,
including two recent workshops in Brazil and Nicaragua.
CDC's Central American office has also facilitated the verification
of Zika cases in several countries throughout Latin America, including
Colombia, Venezuela, and Nicaragua. At the request of the Department of
State's Bureau of Medical Services, staff from CDC's Global Disease
Detection Center in Guatemala has been involved in communication
efforts to ensure that new information regarding Zika virus and its
possible link to birth defects is communicated to U.S. Mission Health
Unit staff throughout the Americas.
Question. Could you specifically speak to family planning accounts
included in the budget and the important role they play in the life of
women and families, particularly as we face a potential Zika outbreak?
Answer. The Title X family planning program is developing
information resources for providers to use when educating clients and
providing client-centered counseling. This includes hosting a webinar
for providers and ensuring that providers have access to the full range
of FDA-approved contraceptives, particularly long acting reversible
contraceptives which can be offered to clients. Additionally, all CDC
guidance is made available to grantees via a program listserv which is
disseminated weekly or as needed for urgent information updates.
The fiscal year 2017 request for family planning is $300 million
and will expand family planning services to low income individuals by
improving access to family planning centers and preventive services.
The request is expected to support family planning services for
approximately 4.3 million persons, with approximately 90 percent having
family incomes at or below 200 percent of the Federal poverty level.
Given our goal of preventing the risk of Zika virus to pregnant
women, and women of childbearing age, we continue to support expanding
access to preventive services such as contraception, and will closely
monitor whether demand exceeds current funding in the context of our
Zika response.
fiscal year 2017 opioid initiative
Question. As you know, I believe that the opioid abuse and heroin
epidemic is a public health emergency. I appreciate the efforts that
the administration has made, but I do not think it is enough. In New
Hampshire, we are losing a person a day, and nationwide each day 120
people die from an overdose. More needs to be done.
Everyone I meet with in New Hampshire tells me more resources are
needed for law enforcement, prevention, intervention, recovery and
treatment. We have chronically underfunded these accounts--and in fact
$483 million dollars would need to be appropriated in fiscal year 2017
to bring the SAMHSA prevention and treatment block grant back to fiscal
year 2006 levels. I am disappointed that an emergency supplemental
funding amendment to provide immediate funds to the States to address
the crisis failed yesterday.
Your budget addresses the drug abuse epidemic by providing $1.1
billion in discretionary and mandatory funding.
How will these funds will get to the healthcare providers and
treatment and prevention professionals at the front lines?
What in your proposal will assist those in recovery?
How will you better coordinate your agencies resources at the State
level and front lines of the crisis?
Answer. Thank you for your continued support and leadership on this
issue. The President's $1 billion opioids investment will expand the
availability of opioid use disorder services by expanding access to
treatment, reducing the cost of treatment, and engaging patients in
treatment. Specifically, this new investment includes $920 million for
new cooperative agreements to expand access to treatment services
across the Nation. These funds will target areas of highest need and
allow States to implement evidence-based strategies that help
individual seek treatment, successfully complete treatment, and sustain
recovery. These funds will meet local treatment needs like medication-
assisted treatment. States may also use these funds to further promote
access to treatment services by expanding the availability of substance
use disorder treatment providers and increasing use of health
information technology. Eligible activities could also include care
transition and care coordination services for those in recovery.
The fiscal year 2017 President's Budget also includes $50 million
for the National Health Service Corps to support additional behavioral
health providers, including those with medication-assisted treatment
training, in communities with healthcare provider shortages, and $30
million for cohort monitoring and evaluation, to understand what works
best and disseminate that knowledge.
Coordination among Federal agencies and with our State and local
partners has been a centerpiece of my strategy for combatting opioid
misuse, abuse, and overdose, and is reflected in the investments
proposed in the fiscal year 2017 President's Budget. This coordination
begins within the Department. Senior staff led by the Office of the
Assistant Secretary for Planning and Evaluation work assiduously to
ensure that efforts at all stages from new research to developing new
treatments to making grant awards and releasing prescribing guidelines
are coordinated and leverage the expertise of the whole Department.
In addition, we are coordinating this work with Federal agency
partners through the Interagency Workgroup on Prescription Drug Abuse
Prevention/Opioid Overdose Prevention, led by the White House's Office
of National Drug Control Policy. One example of the Federal
coordination taking place at this level is the $10 million fiscal year
2017 President's Budget proposal to partner with the Department of
Justice to implement a new Buprenorphine-Prescribing Authority
demonstration to expand the types of providers who can prescribe
Medication-Assisted Treatment.
Coordination also continues between HHS and the States. For
example, since 2014, HHS has held two 50-State meetings on the topic of
opioids and has worked to engage our State and regional partners,
including the National Governors Association, the Association of State
and Territorial Health Officials, and the National Association of State
Alcohol and Drug Abuse Directors in a variety of ways to advance
efforts to prevent opioid use disorder and overdose death and to
identify how best we can leverage our collective resources to bring us
closer to ending this epidemic.
hospital consumer assessment of healthcare providers and systems survey
Question. I recently joined Senator Collins in a letter to you with
concerns about quality metrics, pain management and the move to value
based purchasing.
As you know, as CMS implements the Hospital Value-Based Purchasing
Program, part of the payments will be based on performance of quality
measures, based on patient feedback gleaned from the Hospital Consumer
Assessment of Health Care Providers and Systems, or HCAHPS survey.
I am concerned that the survey questions on pain management may not
be adequate and may serve as an incentive for healthcare providers to
over prescribe.
What is CMS doing to address the inadequate survey questions and
quality metrics related to opioid prescription and what more needs to
be done to enhance provider education on pain management?
Answer. HHS and the Centers for Medicare & Medicaid Services (CMS)
share your concern about the misuse of prescription pain medications,
especially opioids, and how survey questions, including those used on
the Hospital Consumer Assessment of Healthcare Providers and Systems
(HCAHPS) Survey, may affect pain management practices and opioid
prescribing. Last fall, the Administration announced that it will
undertake a review of how pain management is evaluated by patient
experience surveys used by hospitals and other healthcare providers,
including a review of how the questions these surveys use to assess
pain management may relate to pain management practices and opioid
prescribing. We typically test our survey questions on beneficiaries
but we are also committed to consulting with physicians and hospital
administrators as we explore possible changes to the survey. We look
forward to updating you and other interested Senators when this work is
completed. CMS has also launched several educational activities,
including a national webinar in January, which will clarify the proper
use of the HCAHPS Survey and its role in hospital payment, as well as
call attention to revised instructions for proper opioid prescription
practices.
early intervention for misuse and abuse of prescription opioids
Question. The misuse and abuse of prescription opioids and of
illicit drugs has become a true public health crisis, with overdose
deaths quadrupling since 1999. One area that often gets lost in this
debate is primary prevention. This is a critical part of our efforts to
address opioid abuse--stopping it before it starts. Research supported
by the National Institute on Drug Abuse, Substance Abuse and Mental
Health Services Administration and the Centers for Disease Control has
found that early intervention, during pre-school or elementary school
before problems emerge, can reduce risky behaviors during the teen
years. These interventions will not only help reduce substance misuse,
they will also improve academic performance and reduce bullying,
depression, violence, suicide, unsafe sexual behavior and other
problems.
There is 40 years of research behind a prevention first approach
and there are models underway right now that are working, but most
prevention strategies are not in widespread use. My questions are:
The Institute of Medicine has called for 10 percent of public funds
spent on young people to be directed toward effective prevention
interventions that promote healthy behaviors. Can you tell us what
percentage of the President's opioids initiative would be directed
toward prevention? Or what percentage from the overall HHS budget?
Can you tell us how you plan to incorporate primary prevention into
HHS' work addressing the opioid epidemic? How can we help communities
to implement these interventions?
There are multiple grant programs addressing prevention at the
Department of Education, HHS and Justice. How is HHS coordinating with
those departments to leverage resources?
Answer. Again, thank you for your continued support and leadership
on this issue. We know that preventing substance use during youth is a
key factor in preventing future substance use, especially problematic
substance use in adulthood. As noted, several NIDA-funded studies have
found that universal, evidence-based prevention programs targeting
youth such as the Iowa Strengthening Families Program can reduce future
nonmedical use of prescription opioids in high school and early
adulthood.
In general, youth are doing the better than other age groups with
respect to opioids. Rates of nonmedical use of prescription opioids
among people 12-17 years old have been declining since 2002. In 2002,
7.6 percent of individuals 12-17 years old reported nonmedical use of
prescription opioids in the past year compared to 4.7 percent in 2014.
Similarly, opioid-related mortality rates have also remained stable
among 12-17 years since 2002.
It is critical that we focus our resources on where we can have the
greatest impact. As you know, my plan for combatting opioid misuse,
abuse, and overdose is a coordinated, multi-faceted initiative that
relies on education, prevention, and treatment strategies with the
strongest evidence base, and the Department has been working diligently
to develop and implement these strategies. The Department also agrees
that prevention services are critical in addressing the opioid epidemic
across the country. In addition to continuing support for ongoing work
associated with Substance Abuse Prevention through SAMHSA's 20 percent
set-aside for prevention within the Substance Abuse Prevention and
Treatment Block Grant and their Strategic Prevention Framework, the
fiscal year 2017 Budget includes improvements to prescribing practices
as a key area where we can focus our efforts to prevent opioid misuse.
While actions to address prescription opioid abuse must target both
prescribers and high-risk patients, prescribers are the gatekeepers for
preventing inappropriate access. Therefore, HHS is focused on
increasing investments in State-based prescription drug monitoring
programs and adoption of e-prescribing practices, disseminating
guidelines for opioid prescribing, and training providers.
The fiscal year 2017 President's Budget proposes a $13 million
increase for Prescription Drug Overdose and Misuse Prevention, for a
total of $80 million in discretionary resources, to support improved
uptake of CDC's new ``Guideline for Prescribing Opioids for Chronic
Pain'' among providers, and to provide ongoing support to all 50 States
and D.C. through the Prescription Drug Overdose Prevention to States
program. In addition, the budget proposes $5 million in new
discretionary funding for the Office of the National Coordinator for
Health Information Technology to harmonize technical standards in
support of Prescription Drug Monitoring Programs, improve clinical
decisionmaking, and further the adoption of electronic prescribing of
controlled substances. In addition, the SAMHSA State Targeted Response
Cooperative Agreement program, a $920 million effort, will enable
States to identify primary prevention needs in their States. The
program is designed to enable States to develop holistic approaches to
addressing the opioid crisis.
We must work across HHS, with our partner agencies and other
stakeholders, as well as with Congress to identify and dismantle
barriers as well as leverage our resources in order to effectively
implement these strategies. Coordination of HHS activities addressing
opioid use disorders is being led by the Office of the Assistant
Secretary for Planning and Evaluation. In addition, HHS continues to
coordinate its efforts to address opioid addiction and overdose with
its Federal agency partners through the Interagency Workgroup on
Prescription Drug Abuse Prevention/Opioid Overdose Prevention led by
the Office of National Drug Control Policy. One example of the Federal
coordination taking place at this level is the $10 million fiscal year
2017 President's Budget proposal to partner with the Department of
Justice to implement a new Buprenorphine-Prescribing Authority
demonstration to expand the types of providers who can prescribe
Medication-Assisted Treatment.
______
Question Submitted by Senator Tammy Baldwin
national pain strategy
Question. Secretary Burwell, it has been 9 months since HHS closed
the public comment period for the draft version of the National Pain
Strategy (NPS). The NPS was developed by four of HHS' agencies, in
collaboration with the Department of Defense and the Department of
Veterans Affairs, and is intended to provide a comprehensive,
population health-level strategy for pain prevention, treatment,
management, education, reimbursement, and research. In light of the
Nation's opioid crisis, it is critical that the NPS is released and
implemented in an effort to improve pain care with alternatives to
addictive medications. I understand that a final version of the NPS is
awaiting your approval.
Do you have a release date for the NPS? What plans does HHS have in
place to implement the NPS objectives?
Answer. The National Pain Strategy was posted for a public comment
period in April 2015, which generated a robust response. The comments
were carefully considered and incorporated into the report, creating a
stronger plan to improve pain care. Following that important, but time
consuming step, all Department of Health and Human Services (HHS)
agencies, the Department of Defense, and the Veterans Health
Administration, which were involved in its development, carefully
reviewed and revised the report. HHS expects to release the report in
March 2016. Broad ranging efforts across the Government and with
private partners will be needed to implement the objectives of the
National Pain Strategy. The Office of the Assistant Secretary for
Health, in conjunction with HHS operating and staff divisions, will
develop a detailed implementation and evaluation plan after the release
of the Strategy.
SUBCOMMITTEE RECESS
Senator Blunt. And the subcommittee will stand in recess
until 10 a.m. on Thursday, March 10.
Thanks for being here, Secretary.
[Whereupon, at 11:48 a.m., Thursday, March 3, the
subcommittee was recessed, to reconvene at 10 a.m., Thursday,
March 10.]