[Senate Hearing 114-534]
[From the U.S. Government Publishing Office]





                                                        S. Hrg. 114-534

                     PRESIDENT'S FISCAL YEAR 2017 
                         HEALTH CARE PROPOSALS

=======================================================================

                                HEARING

                               before the

                          COMMITTEE ON FINANCE
                          UNITED STATES SENATE

                    ONE HUNDRED FOURTEENTH CONGRESS

                             SECOND SESSION

                               __________

                           FEBRUARY 11, 2016

                               __________

                                     
    
    
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            Printed for the use of the Committee on Finance
                               ______

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                          COMMITTEE ON FINANCE

                     ORRIN G. HATCH, Utah, Chairman

CHUCK GRASSLEY, Iowa                 RON WYDEN, Oregon
MIKE CRAPO, Idaho                    CHARLES E. SCHUMER, New York
PAT ROBERTS, Kansas                  DEBBIE STABENOW, Michigan
MICHAEL B. ENZI, Wyoming             MARIA CANTWELL, Washington
JOHN CORNYN, Texas                   BILL NELSON, Florida
JOHN THUNE, South Dakota             ROBERT MENENDEZ, New Jersey
RICHARD BURR, North Carolina         THOMAS R. CARPER, Delaware
JOHNNY ISAKSON, Georgia              BENJAMIN L. CARDIN, Maryland
ROB PORTMAN, Ohio                    SHERROD BROWN, Ohio
PATRICK J. TOOMEY, Pennsylvania      MICHAEL F. BENNET, Colorado
DANIEL COATS, Indiana                ROBERT P. CASEY, Jr., Pennsylvania
DEAN HELLER, Nevada                  MARK R. WARNER, Virginia
TIM SCOTT, South Carolina

                     Chris Campbell, Staff Director

              Joshua Sheinkman, Democratic Staff Director

                                  (ii)





















                            C O N T E N T S

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                           OPENING STATEMENT

                                                                   Page
Roberts, Hon. Pat, a U.S. Senator from Kansas....................     1

                         ADMINISTRATION WITNESS

Burwell, Hon. Sylvia Mathews, Secretary, Department of Health and 
  Human Services, Washington, DC.................................     2

               ALPHABETICAL LISTING AND APPENDIX MATERIAL

Burwell, Hon. Sylvia Mathews:
    Testimony....................................................     2
    Prepared statement...........................................    41
    Responses to questions from committee members................    47
Hatch, Hon. Orrin G.:
    Prepared statement...........................................   110
Roberts, Hon. Pat:
    Opening statement............................................     1
Wyden, Hon. Ron:
    Prepared statement...........................................   111

                             Communication

National Association of Chain Drug Stores (NACDS)................   113

                                 (iii)
 
                     PRESIDENT'S FISCAL YEAR 2017 
                         HEALTH CARE PROPOSALS

                              ----------                              


                      WEDNESDAY, FEBRUARY 11, 2016

                                       U.S. Senate,
                                      Committee on Finance,
                                                    Washington, DC.
    The hearing was convened, pursuant to notice, at 10:05 
a.m., in room SD-215, Dirksen Senate Office Building, Hon. 
Orrin G. Hatch (chairman of the committee) presiding.
    Present: Senators Grassley, Crapo, Roberts, Thune, Burr, 
Isakson, Portman, Toomey, Coats, Scott, Wyden, Schumer, 
Stabenow, Cantwell, Nelson, Menendez, Carper, Cardin, Bennet, 
Casey, and Warner.
    Also present: Republican Staff: Chris Armstrong, Deputy 
Chief Oversight Counsel; Brett Baker, Health Policy Advisor; 
Kimberly Brandt, Chief Health-care Investigative Counsel; Chris 
Campbell, Staff Director; Jay Khosla, Chief Health Counsel and 
Policy Director; Katie Meyer Simeon, Health Policy Advisor; 
Jeff Wrase, Chief Economist; and Jill Wright, Detailee. 
Democratic Staff: Laura Berntsen, Senior Advisor for Health and 
Human Services; Elizabeth Jurinka, Chief Health Advisor; Matt 
Kazan, Health Policy Advisor; and Joshua Sheinkman, Staff 
Director.

            OPENING STATEMENT OF HON. PAT ROBERTS, 
                   A U.S. SENATOR FROM KANSAS

    Senator Roberts [presiding]. The committee will come to 
order. It is going to be my distinct privilege to introduce 
Secretary Burwell.
    It would appear that Senator Wyden, Senator Grassley, 
Senator Crapo, and the indomitable Senator Schumer are not 
here. They have conflicts, none intended, and I am going to ask 
unanimous consent that the statements by the distinguished 
Senator from Oregon and ranking member, Senator Wyden, and our 
distinguished chairman, Senator Hatch, be inserted in the 
record at this point. Without objection----
    [The prepared statements of Chairman Hatch and Senator 
Wyden appear in the appendix.]
    Senator Roberts. Our witness today is Health and Human 
Services Secretary Sylvia Mathews Burwell. Secretary Burwell 
has been leading the Department of Health and Human Services 
since June of 2014.
    Ms. Burwell has a long history of public-sector service, 
including in her previous position serving as Director of the 
Office of Management and Budget under President Obama. In the 
Clinton administration, Ms. Burwell served as the Deputy 
Director of OMB, the Deputy Chief of Staff to the President, 
Chief of Staff to the Treasury Secretary, and Staff Director at 
the National Economic Council. She has not served as the 
Secretary of Agriculture, however.
    She also has extensive private-sector experience, including 
serving as the president of the Walmart Foundation and, before 
that, as the president of the Global Development Program at the 
Bill and Melinda Gates Foundation.
    Ms. Burwell received her bachelor's degree from Harvard 
University and a second bachelor's degree from Oxford 
University, where she was a Rhodes Scholar.
    Thank you, Madam Secretary, for being here today. We would 
invite you to please proceed with your 5-minute opening 
statement.
    We have inserted the statements by the ranking member and 
the chairman for the record. We will proceed with questions 
following the Secretary's statement.
    Please proceed.

STATEMENT OF HON. SYLVIA MATHEWS BURWELL, SECRETARY, DEPARTMENT 
          OF HEALTH AND HUMAN SERVICES, WASHINGTON, DC

    Secretary Burwell. Thank you, Senator Roberts, and thank 
you, members of the committee. I want to thank you for the 
opportunity to present the President's budget for the 
Department of Health and Human Services.
    As many of you all know, I believe that we have common 
interests and share common ground. In the last legislative 
session, this committee embraced that view of bipartisanship 
and leadership when it took historic steps to pass the Medicare 
Access and CHIP Reauthorization Act of 2015. I want to just 
thank the committee for that leadership on what is a very 
important piece of legislation, for a number of reasons.
    The budget before you today is the final budget for this 
administration and my final budget. The budget makes critical 
investments to protect the health and well-being of the 
American people. It helps ensure that we can do our job to keep 
people safe and healthy, accelerates our progress in scientific 
research and medical innovation, and expands and strengthens 
our health-care system. And it helps us continue to be 
responsible stewards of the taxpayers' 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, as well as other programs. Over the next 10 years, 
these reforms to Medicare would result in savings of $419 
billion.
    This budget invests in the safety and health of all 
Americans. Let me start with an issue we have been working on 
here at home and abroad as we work to stop the spread of zika 
virus. The administration is requesting about $1.8 billion in 
emergency funding, with $1.48 billion of that for the 
Department of Health and Human Services. We appreciate 
Congress's consideration of this important and timely request 
as we implement the essential strategies to fight this virus.
    I know that the rise in opioid misuse and abuse has also 
affected many Americans as well. Every day in America, 78 
people die opioid-related deaths. That is why this budget 
proposes significant funding, over $1 billion, to combat the 
opioid epidemic.
    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 
to try to close that gap.
    Research shows that early intervention can set the course 
for a child's success, and that is why we propose extending and 
expanding the home visiting program to help even more families 
in need to support their child's growth.
    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. This is a vital investment for 
our future. Each 1-percent drop in cancer deaths saves our 
economy approximately $500 billion, not to mention the comfort 
and security it brings to families across the country.
    Today, we are entering a new era in medical science. With 
proposed increases of $107 million for a precision medicine 
initiative and $45 million for the administration's brain 
initiative, we can continue that progress. But for Americans to 
benefit from these breakthroughs in medical science, we need to 
ensure that all Americans have access to quality, affordable 
care. The Affordable Care Act has helped us make historic 
progress. Today, more than 90 percent of Americans have health 
coverage--the first time in the Nation's history that this has 
been true.
    The budget seeks to build on that progress by improving the 
quality of care that patients receive, spending our health-care 
dollars more wisely, and putting an engaged, empowered, and 
educated consumer at the center of their care. By advancing and 
improving the way we pay doctors, coordinate care, and use 
health data and information, we are building a better, smarter, 
healthier system.
    Finally, I want to thank the employees of HHS, who, in the 
past year, have helped to end the Ebola outbreak in West 
Africa, have advanced the frontiers of medical science, and 
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. I am honored to be a part of 
that team. As members of this committee, I think, 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 would be happy to take your questions. Thank 
you.
    [The prepared statement of Secretary Burwell appears in the 
appendix.]
    Senator Roberts. Thank you very much for your statement, 
Madam Secretary.
    You recently stated that you believe we have more work to 
do with the Affordable Care Act, but the marketplace is stable. 
I am going to take the opportunity to remind you that one of 
the five insurers offering coverage in the marketplace in my 
home State of Kansas left the exchange this year, and that 
insurer provided coverage for nearly half of all Kansans last 
year.
    When we hear stories like this, when we say we have assured 
stability, it becomes a problem. I think that data your own 
department released late last year showed that premiums for the 
benchmark plan will increase 16 percent this year in Kansas, 
and that is an increase that is causing great concern.
    So, with insurers already pulling out of the marketplace, I 
am troubled that CMS is taking steps to increase government 
control of the plans available on the exchanges and ultimately 
reduce consumer choice through the new notice of benefit and 
payment parameters. The notice claims that an excessive number 
of health-care plan options make consumers less likely to make 
a selection that leaves them satisfied.
    So my question is, does CMS believe there are too many plan 
choices available on the exchanges? I cannot imagine you would 
say anything else but ``no.''
    Secretary Burwell. With regard to the question of the 
stability in the marketplace, in the marketplace this year, 
most of the folks who came into the marketplace, 9 out of 10 
actually had an ability to be in a market where there are three 
or more issuers, and that is where we believe competition 
occurs. So that was the situation. As I have said and as you 
quoted me, I believe we continue to take steps to further 
stabilize and make sure the market stays stable. We are stable 
now with those numbers, but we need to take steps.
    With regard to the payment notice, I think you know we are 
in the middle of that, and we will be completing that payment 
notice.
    Our objectives today are not about limiting choices for the 
consumer, but instead, making it easier for the consumer to 
make choices, and a number of the steps that we took this year 
in open enrollment are about that.
    We created tools. In the marketplace this year, you could 
actually search plans and understand if the providers that you 
were looking for were a part of that. The other part of what we 
did was create a tool called the ``total cost'' tool, and it is 
a tool that allows you to figure out your deductibles and 
premiums for the year.
    So our objectives in our rulemaking, which we will 
complete, are to continue to promote stability in the market 
and to make sure that there is consumer choice, not to limit 
it.
    Senator Roberts. I appreciate that Acting Administrator 
Slavitt recently announced the creation of a Rural Health 
Council----
    Secretary Burwell. Yes.
    Senator Roberts [continuing]. Whose job will be to review 
all regulations the agency promulgates for their impact on 
rural providers. I know that you have not had time to get up to 
speed on all the details, but I would appreciate any more 
information you could provide to the committee after this 
hearing. I am very much interested in how you see this new 
effort functioning.
    The distinguished Senator Franken is the co-chairman of the 
Rural Health Care Caucus. We would like to know how this new 
council will coordinate with or utilize the work already done 
by the HHS Rural Health Task Force and the HHS National 
Advisory Committee on Rural Health and Human Services. We have 
a lot of folks interested, but there may be some duplication, 
and I hope we can pull that together.
    Secretary Burwell. With regard to the council, the council 
that Acting Administrator Slavitt has pulled together, I think, 
is a response to topics that we have discussed in this 
committee.
    I think you know my personal interest in rural issues. So 
with any regulation that was coming through CMS to me, there 
were a series of questions about rural America that I would ask 
every time. I think what we are now doing is formalizing a 
process by which those analytics that I think are important for 
us to understand are taken into account, because I believe 
rural markets and sometimes urban markets in our country are 
different, and, as we consider our rulemaking, we need to 
consider both.
    So it is formalizing a process that we have been doing 
informally over the past year in terms of that rulemaking. I 
think you hear that it is an issue of interest. We would like 
to work with the Congress in making sure we are considering the 
right things as we ask these questions about the impact on 
rural America.
    Senator Roberts. I appreciate that. Thank you very much.
    Senator Cantwell?
    Senator Cantwell. Thank you, Mr. Chairman.
    Secretary Burwell, it is always good to see you, and thank 
you for all your work on the budget.
    I want to go over a couple of things: one, the 
implementation of the basic health plan, which now some States 
have taken up. I want to get your commitment that you are going 
to implement those plans across America. My understanding with 
New York is, it is already targeting lower premiums and plans 
that are better drivers of driving down cost in the 
marketplace. So I definitely want to get your commitment on 
that.
    Secretary Burwell. Yes. I think you know, in the time that 
I have been here, we have engaged in a number of these, and now 
with New York and Minnesota in terms of the two places. But we 
look forward to other States coming forward with proposals that 
do a number of things. One, they have to meet the basics of 
making sure that the number of people who would have access 
would have access. They need to meet the requirements of the 
health benefits that are required already and in terms of 
deficit neutrality for the Federal Government. But at the same 
time, we know these plans are about access, but they are also 
about States that are doing delivery system reform and thinking 
of more efficient ways to provide quality care.
    So we look forward to working with States as they come 
forward with their plans.
    Senator Cantwell. Well, I think it is very telling when you 
look at this model, because clearly we are talking about the 
lower-
income population that was always hard to serve, in general, 
getting them on an affordable plan, maybe because their 
employer did not offer it or did not have market leverage.
    So to look at New York, with low monthly premiums of only 
$20, it is quite astounding to see that we can provide great 
coverage for a huge population and, as I have always been a 
fan, focus more on managed care, which drives down the cost as 
well. So I look forward to your commitment to working with 
other States on that.
    As the administration also looks at alternative payment 
models to properly incentivize care providers, how are we 
making sure that we are moving ahead, particularly for low 
Medicare rate States like Washington that want to see the 
improvements and not to be penalized, but to be rewarded from 
that? So how are we making sure that we are transitioning off 
of fee-for-service and onto this payment model in a rapid 
fashion?
    Secretary Burwell. There are a number of things we are 
doing. I think you all know that last year, in January, we 
committed, as an administration and at HHS, that we would 
transfer by the end of 2016 30 percent of our payments in 
Medicare to payments based on value, not volume, and that by 
2018, it would be 50 percent of the payments.
    What we are doing is, we are on track to meet that goal for 
this year, which is important. It is important because we are a 
large portion of the dollars, but it is important because of 
the signal that it has sent the market in terms of other people 
coming to that space, whether that is private players or 
Medicaid, like the State of New York, where, in Medicaid, that 
happened.
    Additionally, to your point of rewarding those who are 
making advances in quality and affordability, we also, with our 
Accountable Care Organizations, took the feedback that we have 
received, and, in the next round of those, we have put forward 
changes that hopefully will protect and reward those who are 
already leading in the space.
    Senator Cantwell. On graduate medical education, there is 
something that you guys have entailed on setting the standards 
for emerging needs in health care as it relates to medical 
education.
    What are those standards going to entail?
    Secretary Burwell. What we are trying to do--and this is on 
the Medicare side--is, we do want to make sure that the moneys 
that are for graduate education in the Medicare space are 
targeted toward those who are serving that population, the 
Medicare population. In addition, we want to make sure that we 
are focusing on primary care, where we know we need more 
services, as well as the issue of specialties where we do not 
have enough people.
    So what we are going to try to do is create standards that 
target the money and guide it to the places where (a) it serves 
the population it is supposed to in terms of Medicare, but (b) 
it is targeted to the places where we have shortages.
    Senator Cantwell. Right. I think the problem that we have 
that we really need to focus on is that, given a State 
criteria, you can be in Seattle and be well-served but be in 
Spokane and have a shortage. So we need to focus on the fact 
that, even within a State, you can have great geographic 
differences in what you are doing to serve graduate medical 
education. So it is a very big priority for us to have that 
graduate medical education in Spokane.
    Then my colleague, I am sure, is going to ask you about 
Puerto Rico, but the bottom line is, our colleagues here have 
to understand that, while there is a cap on Medicaid rate 
expenses right now in Puerto Rico, if tens of thousands of 
people come to the United States, there is no cap on that. So 
we are just digging a deeper and deeper hole in our budget by 
not fixing the problem in Puerto Rico.
    Thank you. I will let my colleague, when he gets to that, 
address it.
    Senator Roberts. Senator Coats?
    Senator Coats. As you know, CBO recently came out with an 
estimate that said that in 10 years, without addressing 
mandatory spending and other issues, the mandatory spending and 
interest will consume 99 percent of all Federal revenues. 
Obviously, that is unsustainable.
    You and I have been together in rooms talking about budget 
issues when you were OMB Director. We were not able to reach an 
accommodation on going big, so I decided if we could not do 
that, I would go small. So every week, I would go down to the 
Senate floor and talk about waste, fraud, and abuse and how we 
can save taxpayers money and better use it.
    One of the issues that I am going to be talking about 
actually today is the IG's report regarding improper payments 
through CMS. It is my understanding that the Inspector General 
listed 25 unimplemented recommendations for improvement in 
protecting taxpayers' dollars with CMS. CMS has said it wants 
to address this, but it is short on resources. This is kind of 
a catch-22, because there is an estimate that CMS could have 
saved $1.76 billion if it had followed the recommendation of 
improving automated claims and a number of other things.
    So my question here is, you are asking for more resources. 
I would just like to bring this to your attention. There are 
ways to free up money for absolutely necessary functions for 
CMS, and some of these recommendations or all of these 
recommendations, if they are implemented, can help with that 
process.
    So I wanted to bring that to your attention. I would like 
to get your response to that in terms of the ability to go 
forward and get these recommendations implemented.
    Secretary Burwell. We agree, and I think you probably know 
the 7-to-1 statistic in terms of, for every $1 invested, we 
believe we can save $7, and that is the average over the most 
recent period of time. And last year, together with the Justice 
Department, we had the largest take-down we have had in the 
fraud area. It was over $700 million in one take-down.
    So it is a combination, I think, of things we can do, the 
technology portion of it. We do believe we need finances to 
change and do some of that automation. We have asked for those 
resources.
    In terms of Acting Administrator Slavitt, who I think has 
taken on these issues, I think you may have even had an 
opportunity to speak with him about it. It is an issue that is 
on our regular dashboard of things we are talking about, 
because we believe--just, I think, as you articulated--fraud is 
a very important part that I think we can go at aggressively, 
with data, getting ahead of it instead of chasing it.
    The other part that I think we need to consider is, within 
improper payments, there is fraud and then there is that whole 
category where people are not providing the right data and 
information. We have tightened the requirements in order to do 
things like requiring paperwork before payment so that we get 
in front of it. We find that we are seeing greater numbers of 
people not giving the right paperwork. So we are focused on 
that technical assistance to providers to get the information 
to us, but that is also a place where the resources are 
important.
    Senator Coats. Well, given your experience as OMB Director, 
I know that this is something right in your wheelhouse.
    So, as Secretary of HHS and overseeing CMS, I think you are 
exactly the right person in the right place to get this done, 
and we wish you success in getting these things implemented 
here, because it can free up funds, necessary funds, for 
programs that may be waiting for those funds.
    Secretary Burwell. Absolutely, and that is why we are 
hopeful that our budget request--that particular part of the 
budget request--results in greater savings. The 7-to-1 number 
is what we have seen on the average of the last 3 years.
    Senator Coats. Thank you.
    Mr. Chairman, I have 40 seconds left, which I yield back in 
the interest of a vote coming up.
    The Chairman. Well, you are just great to do that. Who is 
next?
    Senator Wyden?
    Senator Wyden. Thank you, Mr. Chairman.
    I will only ask one question on this round, given 
colleagues being here. We are very pleased the Secretary is 
here. Secretary Burwell, in my view, gives public service a 
good name. We are glad that she is here.
    The issue of opioid abuse is widespread across the country, 
and it is of particular concern to Oregon. I think colleagues 
know that I have opened an investigation into potential 
conflicts of interest between opioid manufacturers and the pain 
industry. The concern here is that the manufacturers may be 
trying to influence opioid prescribing practices, and we will 
have more to say on that in the days ahead.
    Now, Oregon has been among the States with the highest non-
medical use of prescription pain relievers. The CDC estimates 
that 1 in 15 people who take prescription pain killers for non-
medical purposes are going to try heroin within 10 years. 
Nationally, health care providers write enough prescriptions 
for opioid pain relievers for every adult American to have a 
bottle of pills.
    Many studies and experts have found that physicians are 
inadequately trained on pain management. This past week, I sent 
a letter to the CDC Director to offer my support for the CDC's 
draft Guideline for Prescribing Opioids for Chronic Pain, which 
will help prescribers have consistent evidence-based guidance 
for appropriate opioid prescribing.
    So set aside, for purposes of this morning, Madam 
Secretary, this question of the investigation into potential 
conflicts of interest. We will talk more about that in the 
future. But for purposes of this morning, what does HHS plan to 
do to ensure that opioids are prescribed more appropriately, 
and what is the plan to reduce the number of people using 
prescription pain relievers for non-medical purposes?
    Secretary Burwell. When I came to HHS in June of 2014, this 
was one of the priorities that I chose as a Secretary, because 
I am from the State of West Virginia, where I think many of you 
know the problem is acute, as in neighboring States, but also 
all over the country. I have visited in Colorado, Pennsylvania 
too--across the country.
    So we put together a three-part strategy based on the 
evidence that we had seen to date in terms of the most 
important levers that the Federal Government and HHS have. It 
was three parts, with number one being the issue you just 
touched on, and that is prescribing. Prescribing is how this 
starts. It is how it starts in terms of the prescription 
medication.
    As you reflected, so many people who do heroin, it is after 
they have done prescription drugs. In Colorado, I met a young 
woman who said after 3 months, heroin was cheaper, easier to 
get, and a better high. So we see that. And she had started 
with her wisdom teeth being pulled and taking the drugs.
    So, first, prescribing practices, that is the work that CDC 
is doing.
    Second, medication-assisted treatment, and this is the 
approach that I think there is broad bipartisan support for, 
and it is supported at the State level, with the Governors, 
with sheriffs, with everyone, in terms of making sure that we 
are getting the treatment for the people, because right now, in 
our State, across the country, we have so many people who are 
already addicted.
    That is what the vast majority of the moneys that we have 
in this proposal, in our budget, do. It is important to note 
that is money that will go to States and communities. It will 
go through SAMHSA and it will go through HRSA, but the vast 
majority of those dollars are to get out so that we can build 
that capacity in States and communities to do medication-
assisted treatment.
    The third part of the strategy is naloxone, and, sadly, we 
do have a situation where many people overdose, and you all 
know the numbers. As I mentioned in my testimony, 78 people a 
day in the country are dying an opioid-related death. That 
overdose can be prevented from being a death by applying 
naloxone, sometimes called Narcan.
    So part of the moneys are about making sure that we are 
able to help and support communities to get access to that 
drug, to their first responders, as well as, we recently saw 
organizations like CVS and Walgreens working to make this drug 
an over-the-counter drug in States.
    Senator Wyden. With so many other colleagues waiting to ask 
questions, Mr. Chairman, I will ask some others on future 
rounds.
    The Chairman. Thank you, Senator.
    Senator Thune is next.
    Senator Thune. Thank you, Mr. Chairman.
    Madam Secretary, welcome; nice to have you here. I 
appreciate that I have been able to discuss some of these 
issues with you previously. But I want to raise some concerns 
we have had about the Great Plains Area Indian Health Service. 
The reports coming out of there have been unacceptable. 
Unfortunately, there has been a failure to deliver on the 
promises to fix health-care services in this area.
    Reports of IHS's failings were issued in 2010, 2011, and 
2013, and in 2014 I was informed that a contractor was in place 
to strengthen the link between external oversight and the 
development of effective patient care processes. Report after 
report, it covers the same issues. Yet, when it comes to fixing 
these issues, the administration seems to continuously fail.
    So I would like to know from you what the administration 
has done in the past few years to engage with tribes in the 
Great Plains area to make meaningful reforms to the system and 
to ensure that patients receive the quality care that they 
deserve.
    So, if you could, talk a little bit about that.
    Secretary Burwell. Yes. Thank you, Senator. I share your 
concerns in terms of the progress that has not been made that 
needs to be made.
    There are a number of changes that we are making right now 
in terms of trying to get a different result from where we are. 
I think it was important, though, that when CMS said that we 
did not have safety and quality issues, that we acted upon that 
to protect the health and well-being of the folks. That still 
means they need access to quality and how do we get there.
    First, in the region itself, we actually, I think you know, 
have changed the leadership in the region. In addition, we are 
supporting that by sending some of our Public Health Commission 
Corps officers who work on quality issues in to supplement the 
IHS folks on the ground.
    In addition, at the Department itself, we are doing quality 
and management changes, because I think it is both about 
meeting the quality standards and management and cultures that 
we need to make some changes in. And we have hired a Deputy, 
Dorothy Dupree, who has come from the field to work on the 
quality issues, and brought in Mary Smith as another Deputy to 
work on the management issues.
    In addition, I think you saw in the hearing which you were 
in--and I thank this committee for her hearing--I specifically 
asked the Acting Deputy, Dr. Mary Wakefield, to actually put 
together an interagency group within the Department of Health 
and Human Services, which met yesterday, to set specific goals 
of what we can achieve during our time.
    Senator Thune. Thank you. We will look forward to 
continuing to follow up on those issues.
    I want to change gears for just a moment and ask about--and 
this is kind of more forward-looking, I hope--how we can make 
reforms at the IHS. I would like to follow up on at least an 
issue that I have addressed with the officials at IHS.
    Late last year, I requested an update on when the 
administration would finalize a regulation that was initially 
published in December of 2104 which would expand Medicare-like 
rates for physician and non-hospital-based services under the 
Purchased and Referred Care program.
    I understand from the budget proposal that this regulation 
is awaiting approval at OMB, and I am encouraged by what we are 
hearing about the progress, and I am interested in when you 
believe that this regulation will be posted. And, additionally, 
I would like to know how the administration plans to conduct 
its consultation with the nine tribes in South Dakota.
    Secretary Burwell. With regard to the specific regulation 
that you are speaking of, yes, it is at OMB under its review 
process, and that is generally a 90-day process.
    The comments come back to us, and the question is how 
extensive those are in terms of the timing. But it is at a late 
stage of the regulatory process, and it is one that is a 
priority for us in terms of those that we have gotten to OMB.
    So we are hopeful that soon we will get it out. I think it 
is also related to the issue that I think you know about, 
because your State and your Governor have been an important 
part, as has Alaska, of changing the way we do some other 
payment issues that are not a part of that regulation, but I 
think are important to the payment system and how we provide 
health care.
    So we are working on the regulatory front, but we are also 
working on something that does not, I think you know, require 
the same process in terms of the payment. And I think you know 
we are changing some of the matching rates.
    Senator Thune. Right. I appreciate the effort there and 
would just encourage you to continue to push OMB to be able to 
move forward with the finalization of that regulation.
    I have written you in the past too regarding one area of 
improvement, which is the electronic mechanisms used to 
exchange information in the claims and payment process, and in 
the Purchased and Referred Care program, claims are still being 
mailed back and forth. My understanding is, the administration 
is considering a move to electronic claim payments, and we 
would be interested in an update, if that is something that the 
administration believes is feasible.
    Secretary Burwell. With regard to the specifics of where 
that one is, I would like to get back to you on it. But the 
overall concept, I think you know, with the emphasis in our 
delivery system reform--one of the anchors of the strategy 
there--is electronic health benefits and data and information 
and the ability to move that more quickly so we improve quality 
and we improve affordability.
    So it fits within that overall strategy of all that we are 
trying to do. Where it specifically is at this moment, I will 
need to get back to you on.
    Senator Thune. We appreciate that. Thank you.
    My time is up. Thank you, Mr. Chairman.
    The Chairman. Thank you.
    Senator Nelson?
    Senator Nelson. Under the ACA, 17.6 million people now have 
health care. Louisiana is expected to expand Medicaid in their 
legislative session. That is another 400,000 people. That is 18 
million.
    The Republican Governor States that have refused to expand 
Medicaid and will eventually is another 4 million. So 18 
million plus 4 million is 22 million--22 million people will 
have health care out of an eligible population of 34 million 
that did not have health care. That is two-thirds. To use the 
lexicon of today, that is a huge success. I do not think that 
that story is really understood, how successful the ACA is.
    Now, if you wonder where I got the 34 million, I am taking 
45 million, which was the population that did not have health 
care, and I am subtracting those who are here illegally, 11 
million, to get 34 million--22 out of 34 million will have 
health care. That is a success.
    I want you to chronicle that story.
    Secretary Burwell. I think when we think about the issue of 
the success, it is around affordability, access, and quality. 
And, as you appropriately reflect on the access point, as I 
mentioned in my opening testimony, we are now at a place where 
over 90 percent of Americans have insurance in the country, and 
that is a very big change from where we were.
    For Medicaid, 14 million additional folks are in Medicaid 
from 2013 to now, and we know in the marketplace that 17.6 
million, as well as other numbers in terms of that reduction.
    The other thing that I think it is important to reflect is, 
when we have low unemployment, people have health insurance 
through that as well.
    So all those things are coming together to put that 
downward pressure, but I do not think we can forget the other 
things, like preexisting conditions, and so many Americans know 
people who have had cancer, who have asthma, and that has been 
a very important change that I think many people think is very 
beneficial, as well as preventative care.
    That gets a little bit to what Senator Cantwell said and 
some of the issues we have all discussed about downward 
pressure on price.
    Senator Nelson. Puerto Rico, the mosquito that is in Puerto 
Rico that has spread a lot of dengue fever is the same mosquito 
that carries the zika virus. Now, fortunately, the zika virus 
produces a flu-like symptom that is relatively moderate. But 
where it is having these tragic results is on pregnant women 
with children who are deformed.
    Puerto Rico needs help, and, lo and behold, if Puerto Rican 
pregnant women are being exposed and they have this tragic 
result of these defective births, that is going to be an 
additional expense upon the health-care system to take care of 
these babies. I know you put $250 million in your budget to 
curb what is expected to be, in Puerto Rico, this outbreak of 
zika. Do you want to comment about this?
    Secretary Burwell. Yes. With regard to the zika virus, the 
concern that we have right now, and the plan that we have put 
in place, is about preventing further damage and focusing 
specifically on pregnant women. What we know is that, on the 
island of Puerto Rico, this mosquito is a very dominant 
presence. It is a mosquito that will sometimes bite four humans 
in one feeding and, therefore, it spreads the disease quickly.
    So also, because 80 percent of the people actually are not 
symptomatic, you do not necessarily know if you have had it. So 
it is important to get resources to Puerto Rico in terms of 
pregnant women, taking care of and protecting them, and us 
doing mosquito control.
    It is not just for Puerto Rico. Puerto Rico is the place 
where we expect that we will see the most cases, and we have 
had mosquito transmission already. But in the continental U.S., 
in States like Florida and Texas, we are also concerned, 
because this mosquito is prevalent as well, and we want to make 
sure that we are putting the resources against preventing as 
much spread as we can of the zika virus.
    The Chairman. Senator Bennet?
    Senator Bennet. Thank you, Mr. Chairman.
    Thank you, Madam Secretary, for your public service and 
your leadership.
    I want to continue along the lines that Senator Nelson was 
talking about, with respect to zika virus, and broaden the 
question a little bit. As you know, the CDC's Division of 
Vector-Borne Diseases in Fort Collins, CO has been on the 
frontline of studying and monitoring the issue of this disease 
for years.
    The President, as you mentioned in your opening 
presentation, has proposed $1.8 billion to respond to the zika 
virus. Can you give us more detail about how you propose to 
spend that money and what role the Division of Vector-Borne 
Diseases would play in responding to the virus?
    Secretary Burwell. We are very appreciative of the work 
that they have done to date. Because the issue of testing for 
zika is something that is occurring mainly with the CDC and 
there in Fort Collins, that is where a lot of the testing is 
occurring. We are trying to move the testing out to States so 
it will be more proximate to those in need.
    That is a part of what that money is about, making sure 
that States will have the capacity to test, because for any 
woman who has gone to Mexico--and we know the estimates are 
about 450,000 pregnant women travel to these regions where zika 
is--if they come back infected, they will not necessarily know, 
because 80 percent of people do not know they have the disease.
    So if you are pregnant and come back, you most likely will 
be tested, and we recommend you are tested if you have gone to 
this region. Therefore, a lot of the money is about making sure 
that the States are going to have that testing capability.
    Senator Bennet. Thank you. I want to shift gears a little 
bit. Senator Grassley and I, along with Senators Nelson, Brown, 
and Portman, introduced the ACE Kids Act. Our bill now has 30 
cosponsors. It would improve care for children with medically 
complex conditions like cancer, congenital heart disease, and 
Down syndrome. Approximately two-thirds of the 3 million 
children with medically complex conditions in the U.S. are 
covered by Medicaid. These children account for an estimated 6 
percent of Medicaid enrollees and nearly 40 percent of Medicaid 
costs for kids.
    Our bill would create a national framework of world-class 
providers and hospitals in the Medicaid program that would 
coordinate care across State lines on behalf of these children. 
I know HHS has worked within certain States to test these types 
of models. We hope to develop it nationally and work across 
State lines.
    Senator Grassley and I are working with our Finance 
Committee cosponsors and Senators Hatch and Wyden to try to 
pass the bill.
    I am bringing it to your attention because, as you know, 
operating Medicaid across State lines is not easy, the way it 
is designed, and we are going to need assistance from your team 
at CMS to pass the law this year.
    Is this something that you would be willing to prioritize?
    Secretary Burwell. Yes. We want to work with the authority 
we have to do some of the things that we can do that are ideas 
and concepts, and we want to work with you on ensuring that we 
can do all the work that we can to make sure that these kinds 
of children are served.
    Senator Bennet. Great. I appreciate that. I think we could 
do a much better job of providing better care at a lower cost 
if we could coordinate it. So thank you.
    With that, Mr. Chairman, I will yield back, because I know 
there is a vote. Thank you.
    The Chairman. Thank you. I appreciate it.
    We are going to go to Senator Portman. I apologize to you, 
Madam Secretary; I will be back, but the bill on the floor is 
my bill, and I am going to have to at least go vote on it.
    Senator Portman will take over, and then my staff will say 
who is next. If any Republican Senator is here, they can direct 
who is next.
    Senator Portman?
    Senator Portman [presiding]. Thank you, Mr. Chairman. It is 
a privilege to have the gavel. I will not abuse it.
    Thank you, Madam Secretary, for reaching out before this 
hearing and seeking my counsel. Of course, I had none for you, 
except to say that we have differences on this budget.
    I agree with what Senator Bennet just said about the 
importance of our Kids Health Act, which is called the ACE Act, 
which will help, as he said, improve care, but also reduce 
costs. I would love to work with you on that.
    We do have some differences on the big picture: $3.3 
trillion in new taxes. You and I have talked about some of 
these fiscal challenges we face that are not resolved in this 
budget.
    But I want to talk about something that I like in the 
budget, and that is the work on opioid addiction. So 
prescription drug and heroin addiction is at epidemic levels in 
my State and around the country, and we are losing, as you 
indicate, lives every single day. We lost over 2,300 in Ohio in 
this last year alone.
    We have, over the last 3 years, been working on legislation 
that is bipartisan and comprehensive. We have had over a dozen 
meetings up here with experts from around the country. We tried 
to bring in the best people to figure out how to get at this 
problem. You and I have talked about it, and you have reached 
out to me, and I appreciate that, over the last several years 
on this issue.
    That legislation, called CARA, Comprehensive Addiction and 
Recovery Act, just passed the Judiciary Committee while you 
were testifying, and it passed, as I understand it, by a voice 
vote. In other words, it was unanimous. That does not happen 
around here.
    So I am going to thank you for what is in the budget, 
because what you put in the budget is consistent with CARA and 
provides more funding specifically for treatment.
    One of the things I like about your budget is, it also 
provides some funding to look at--and I am reading from your 
budget--``evaluating the effectiveness of treatment programs.'' 
So it is research at the Federal level and best practices, 
because not all medication and treatment programs are equal. 
Some work better than others, and some that I have visited in 
Ohio have incredible results. Others, frankly, are struggling.
    So I think that is important too, at the Federal level, to 
provide that. So I encourage you to continue to do that. I know 
you have a personal interest in this and a passion for it.
    Senator Whitehouse is the other co-author of this, but we 
have a bipartisan group. We have over 120 groups from around 
the country that have now supported us on this, including the 
National Association of District Attorneys, the Attorneys 
Generals--I think 38 of them now endorse the bill--the groups 
who represent the people who work in the trenches every day in 
the States, they have endorsed it.
    This is one that we can actually get done, and I know that 
the White House has said generally good things about the bill 
but has not been willing yet to say that they support it. I 
hope you will support it. I hope you will get behind it. We 
understand there has to be funding that goes along with it, and 
that is why I think the budget is a step in the right 
direction.
    The funding that we got in at year-end will help, but we 
will need additional funding to be sure that the legislation, 
which is authorization, can actually be implemented in the 
proper way.
    I wonder if you have any thoughts on CARA you could share 
with us today.
    Secretary Burwell. First, thank you for your leadership in 
this space. It is important to the progress that I think we can 
make in terms of a number of folks, and you certainly have been 
a strong leader. And I appreciate our conversations about these 
issues as well.
    I think, as you said, it aligns with the strategy that I 
articulated earlier in this hearing, which the bill addresses. 
I think we want to continue to work, and I am hopeful. I think 
you know I just have 11 months, and I hope that we will start 
to see the results of our efforts, but it is going to take 
longer. But the idea is that we can put in as many as possible 
of the things that I think we need to do and that support for 
the medication-assisted treatment, as well as these prescriber 
issues that we are going to face when we get the new 
guidelines.
    So we look forward to continuing to work with you on it. I 
am glad to hear about the vote. I, obviously, was here, so I 
did not know.
    Senator Portman. Thank you. We are encouraged by the vote 
and also by the amount of support we are getting from around 
the country on this. I think the administration weighing in 
more precisely on this legislation would help us to get it 
through the process without what often happens around here, 
which is political games. And we are going to see it. People 
will offer amendments to it to try to kill it. People will say 
this is about politics.
    It has never been about politics. We have been working on 
this for years. We have kept it not just bipartisan, but 
nonpartisan. But we would love your help to get this to the 
President's desk, where I believe he would be very pleased to 
sign it to start this new strategy to be able to have the 
Federal Government play a more important role, a better 
partnership role, with State and local governments and 
nonprofits to address what is a crisis in our communities.
    There is other legislation, as you know, that Senator 
Toomey and myself, Senator Brown, and others, have introduced. 
It is called the Stopping Medication Abuse and Protecting 
Seniors Act. This helps us to be able to save lives by reducing 
the likelihood that patients in Medicare are doctor-shopping, 
getting prescriptions for pain medications from multiple 
doctors, multiple pharmacies.
    We have cosponsors on both sides of the aisle. We know 
these programs work in the private plans. The CMS Administrator 
testified several weeks ago that Medicare is prohibited from 
using this important tool.
    I know your budget touches on this, but I wonder if you 
could comment on that legislation and your view on this and 
whether we can also move that legislation forward to avoid some 
of this prescription drug abuse that is causing the problem.
    Secretary Burwell. As was commented by CMS, in terms of our 
ability to do it, I think you know, it would come statutorily. 
We see Medicaid programs in States doing it, as well as the 
private sector.
    I think the one concern we just want to make sure of is 
that we do not make access too hard. Pain is an important issue 
in terms of the issuance. So I think we agree we can do a much 
better job, which I think is what the objective of the bill is, 
in terms of controlling this access to these drugs in terms of 
providers and pharmacies. We just want to make sure we do it in 
a way that does not inhibit access for those who actually need 
it.
    Senator Portman. Thank you, Madam Secretary. I look forward 
to working with you on that as well, because it does require a 
statutory change.
    Thank you, Mr. Chairman.
    Senator Menendez?
    Senator Menendez. Thank you, Mr. Chairman. We have rotating 
chairmanships today, so I am getting confused.
    Madam Secretary, thank you for your service to our country. 
I think you do an outstanding job.
    As you know, Congress passed the Autism CARES Act in August 
of 2014, which I wrote to continue the research, the 
intervention, the support programs that existed under the old-
named Combating Autism Act. While the CARES Act contains 
requirements that HHS conduct research into key areas impacting 
the autism community, chief among them is a report focused on 
young adults and youth with autism who are transitioning out of 
school-based support services into the larger community.
    According to the CDC data, one in 68 children nationally 
and, unfortunately, one in 45 in my home State of New Jersey is 
identified with autism spectrum disorder. Early diagnosis and 
interventions have come a long way to support these children, 
but, unfortunately, youth and adults do not have the same 
access to support and services after they leave the schools. So 
the happenstance of a date on the calendar changes their lives 
dramatically.
    After the law's passage, I convened a roundtable discussion 
with key autism community leaders in New Jersey. This issue of 
aging out and transitioning to community-based services was 
something that was consistently mentioned as an area in dire 
need of attention, which is exactly why I mandated this report, 
which would provide Congress, the agencies, researchers, and 
providers with a comprehensive understanding of not only what 
services are currently available, but what we need to do to 
ensure that every individual with an autism spectrum disorder 
can succeed in adulthood.
    Now, the report on young adults and transitioning youth is 
due to Congress this upcoming August, 2 years after the Autism 
CARES Act was signed into law. Can you provide us with an 
update on the progress of the report and confirm that it will 
be completed by the statutory deadline?
    Secretary Burwell. First, thank you for your leadership in 
this space, because it is important to helping us do the work 
that we do.
    We are working on this report, and I will find out in terms 
of the specific question you are asking on August exactly and 
come back to you.
    Senator Menendez. I am concerned because I understand, and 
my understanding may be wrong, that this has not even been 
started. So, if that is the case, I do not know how we make the 
August deadline. But I hope I am wrong and you will give me 
better news than that. But if not, then I would like to give it 
a sense of urgency.
    Now, I know many of my colleagues have talked about the 
opioid epidemic, and, of course, it deserves that attention. 
Last year, in New Jersey, heroin deaths in our State were up 
160 percent since 2010, and we suffered more than 1,200 
overdose-related deaths. So this is really an epidemic.
    Now, I recently held a listening session with key addiction 
treatment stakeholders in New Jersey to address this growing 
crisis, and, to a person, the issue that came up most 
frequently--there were many, but the one that came up across 
the spectrum as the most substantial barrier to addiction 
treatment was the limitation on a provider's ability to conduct 
medication-assisted treatment.
    As you may know, these limitations cap a provider's ability 
to treat, at most, 100 patients. Now, with the number of people 
seeking treatment far outpacing the number of providers who can 
help, it seems to me that this is an outdated limitation tying 
providers hands and limiting treatment to those who need it the 
most.
    So I would certainly like to see a broader provider 
universe, but when something is an epidemic, you need to figure 
out that maybe an artificial cap set at some time past is now 
not appropriate for the moment.
    So while I appreciate the administration's bold request for 
additional funds in this area--and I intend to be as vigorously 
supportive of it as I can--what can we do to increase the 
access to medication-assisted treatment, and what further 
efforts can the Department take under its current authorities?
    Secretary Burwell. I think that is specifically 
buprenorphine, that specific drug, in terms of the medication, 
and that specific type of medication-assisted treatment. Right 
now, we are actually in the middle of changing our regulations 
and proposals and using as much of our administrative authority 
as possible to change that.
    So that is something that I would expect to happen this 
year. With buprenorphine, as Senator Portman indicated, it is a 
place where the questions of diversion of it and use are the 
things that we want to make sure of. I think we believe that we 
can expand those caps and move those numbers without creating 
that problem, but that is what we are working on right now, 
using our administrative authority.
    I would also reflect that as part of the budget, in the 
budget, there is a proposal to actually expand the ability for 
trained people in correct settings--in other words, making sure 
that others beyond physicians might be able to use it, meeting 
certain criteria.
    So there are two fronts we are working on. One is within 
the budget; the other is administrative action we are taking 
where we think we can get to this.
    Senator Menendez. I would appreciate it if your staff would 
keep us abreast of how that administrative function is moving.
    Finally, I just want to mention, if I may, Mr. Chairman, I 
know my colleagues have brought it up, but I hope that your 
department will do everything you can to take the 
administrative steps that are possible within your wherewithal 
on the health-care crisis in Puerto Rico.
    I listen to the stories from people on the island, and I 
listen to their families in New Jersey, and it is getting way 
out of hand. There are other issues that they have in terms of 
their finances, but this is an issue that is of increasing 
concern. I hope that you will see what administrative powers 
you have to help the people, the 3.5 million American citizens 
who just happen to live in Puerto Rico.
    Secretary Burwell. We are very focused in terms of the 
administrative actions we can take, and have taken a number of 
those in the Medicare space.
    I think, as you know, the Medicaid space is where large 
dollars and large amounts of care are very important, and it is 
on unequal footing. I am sure this committee spent time 
yesterday with my colleague, Secretary Lew, on important 
legislation that needs to occur in this area.
    But I would be remiss if I did not emphasize the importance 
of some of the help, and what we are trying to do is make sure 
that Americans in Puerto Rico have equitable care with regard 
to Medicaid in terms of those rates, and that is what the 
proposal is in the budget. At the same time, we will do 
everything we can from an administrative perspective.
    I also think the issue that was just raised about zika is 
particularly important. When one thinks about the costs that 
Senator Nelson was mentioning, CDC estimates that for children 
who are born with some of these severe birth defects, depending 
on the severity, that the cost is $1 million to $10 million per 
child.
    So making sure that we are doing everything we can right 
now to help and assist and support Puerto Rico in preventing 
cases of zika in pregnant women that could, in turn, lead to 
these additional issues, is a place that is a priority focus.
    I think you probably heard--I have spoken to that in the 
past several days, in terms of the urgency of the need, of the 
financial assistance to it.
    Senator Menendez. I appreciate your answers. We are ready 
and willing to do whatever we can from this side of the Capitol 
to be helpful in your efforts there.
    Secretary Burwell. Thank you.
    Senator Menendez. Thank you, Mr. Chairman.
    Senator Isakson [presiding]. Thank you, Senator Menendez.
    Secretary Burwell, welcome.
    Secretary Burwell. Thank you.
    Senator Isakson. Let me just say in public what I told you 
in private 2 days ago on the phone. I want to tell you how much 
I appreciate your accessibility, your willingness to work to 
solve problems, and I appreciate everything you have done for 
us in Georgia. Thank you very much.
    You are on the Moonshot Task Force for cancer cures, is 
that not correct?
    Secretary Burwell. I am.
    Senator Isakson. I have a homework assignment for you.
    Secretary Burwell. All right.
    Senator Isakson. The Surgeon General, in 2014, said skin 
cancer was the fastest-growing killer of all cancers, and 
melanoma the fastest-growing of the skin cancers.
    As one who has survived two melanomas in my life, I took 
that on as a call to action and started investigating what was 
happening at FDA and found out there was a 13-year backlog of 
ingredients that had been submitted to FDA for approval in 
sunscreen that had been delayed in terms of the processing of 
their approval. So we passed the Sunscreen Innovation Act out 
of the Health, Education, Labor, and Pensions Committee, passed 
it on the floor, passed it by the House, and got it signed by 
the President. Fourteen months later, none of those ingredients 
has been approved yet. Nothing has moved forward.
    To quote the President, he has asked you to identify and 
address any unnecessary regulatory barriers and consider ways 
to expedite administrative reforms. Would you please make the 
first item on your agenda the Sunscreen Innovation Act and 
getting those backlogged sunscreen additives approved?
    Secretary Burwell. With regard to the issue, we have had 
time, and, since last year, I have spent time on this issue. 
One of the things in terms of those ingredients is, we actually 
need the data and information from the actual manufacturing 
companies.
    I think you know we are working with them, being very clear 
about, here is what we would need to meet the standard of 
approval, and that is part of what the Act did, in terms of the 
new Act: making sure that we meet the standards.
    The sunscreens, and I think everyone knows, now we put them 
on every day because we know what you said is a true thing. On 
our children, our 8- and our 6-year-old, every day in the 
summer, those sunscreens are going on. The question of what 
that sunscreen does in terms of absorption in the skin and 
whether it causes other issues, that is what we want to just 
make sure. We just want to get to a base level of safety.
    We are being very clear. We heard you when you talked to us 
last year about this issue, and we are trying to work with the 
companies to be very clear about, this is the data we need. And 
for us, if they are saying that it was approved in another 
place, then can we just see the data, can we just see the 
analytics, to make sure that we know what we are putting on 
children is safe?
    So this is one we will continue to work on. We want to make 
progress on it too. We are trying to work with industry to make 
sure that we are being clear, that we make it as simple as 
possible to get the information we need to make sure it is 
safe.
    Senator Isakson. I will do a favor for you. If you will get 
me the information that I need to call them to tell them to 
expedite getting submitted to you, I will do that if--and I 
have just been handed this, so I take responsibility for the 
accuracy of this, but I have a great staff. [Laughter.]
    It says FDA has moved the goalpost and is now requiring a 
new test that no one has ever heard of. So I will check on what 
that is if you will check on that too, and we can see if we can 
get the barrier removed, because I think it is important to get 
these done as fast as possible.
    On the zika virus, I know Tom Frieden and I talked last 
week. I think the estimated request is $1.48 billion; is that 
correct?
    Secretary Burwell. That is correct, $1.48 billion for HHS.
    Senator Isakson. In another hearing I was a part of, I 
heard there was money left in the Ebola fund that had not been 
spent yet, and somebody had suggested using some of that to go 
toward zika until we can get the bill through the Congress on 
zika.
    That would be fine, but please do one thing for me. There 
were private hospitals that assisted the administration in 
responding to the Ebola crisis. They were told they would be 
reimbursed for their costs as they responded, so make sure they 
have all been reimbursed before you spend that on something 
else.
    Secretary Burwell. Yes, sir, Senator. One of the things I 
think we want to make sure of is that we finish the job on 
Ebola. That is a very important thing for us to do. We know 
that just this last week, a new case in Sierra Leone has 
occurred.
    So even when we had declared it clean, we have a new case. 
And the good news is, they were swabbing dead bodies to 
continue watching for it, and that is how we found it. We were 
able to do the contact tracing and everything. So we need to 
make sure we finish the job on Ebola, including making sure we 
pay those communities, hospitals like Emory and others, that 
helped with this issue.
    Senator Isakson. CDC did a marvelous job in responding to 
it, and the administration is great in what they did. I just 
want to make sure everybody who was going to get reimbursed 
gets reimbursed.
    Lastly, one of the companies in my State is Equifax. 
Equifax is a provider, I think, to CMS to verify income and 
eligibility for Medicaid eligibility and things of that nature.
    Make sure that you all are utilizing those people. They are 
not the only provider. I know we have a lot of things fall 
through the cracks, and things are paid that should not have 
been paid because people really were not eligible when they 
claimed they were.
    I understand there is an underutilization of those 
verifications. If you would, follow up on that to make sure we 
are using the available resources, which are cost-free to us, 
to make sure that those eligible for Medicaid are, in fact, 
eligible and getting the benefits.
    Thank you very much.
    Secretary Burwell. Thank you.
    The Chairman. Senator Casey, I have not asked my questions 
yet, nor have I even greeted our distinguished Secretary. If I 
can just greet her, and then I will ask my questions after you.
    Welcome.
    Secretary Burwell. Thank you. Thank you, Mr. Chairman.
    The Chairman. Sorry. The big bill on the floor is mine----
    Secretary Burwell. That is all right.
    The Chairman [continuing]. And I have been running back and 
forth. I had a bill in the Judiciary Committee as well.
    I just want to welcome you to the committee, and I am sorry 
it is belated. But I am very pleased with the hard work that 
you are doing. It is a tough job, and I think you are doing it 
in about as straightforward and good a way as I could expect.
    So I just want to let you know that I am proud of you and 
want to keep working with you. So listen to our side too, and 
we may be able to get a lot done here if we do.
    But we are happy to have you here. I will have some 
questions for you after Senator Casey.
    Secretary Burwell. Thank you.
    Senator Casey. Mr. Chairman, thank you very much.
    Secretary Burwell, thank you for being here, and thanks for 
your stellar public service at a difficult time.
    I have two questions, and I will get to them quickly, but I 
hate to pass up the opportunity to report some good news. We 
need that around here once in a while. Someone has to talk 
about good news.
    Just some numbers. You do not have to respond, but I was 
struck by some of these. Between 2010 and 2014, 87,000 fewer 
patients died in hospitals due to hospital-acquired 
infections--that is a good number; there were 150,000 fewer 
readmissions, which is good for the individual and good for 
saving money.
    But in the budget presentation, I was happy to see a lot of 
things, but I will just hit some highlights--and this will not 
be fair to every priority--but a couple of things.
    Requiring coverage of the Early Periodic Screening, 
Diagnosis, and Treatment program for children's inpatient 
psychiatric treatment facilities; providing full Medicaid 
coverage for pregnant and post-partum beneficiaries; extending 
the Children's Health Insurance funding through 2019; and the 
new initiative or, I should say, the new dollars for an 
existing initiative, the Maternal, Infant, and Early Childhood 
Home Visiting program, a $15-billion investment over 10 years. 
It is voluntary, and it is evidence-based home visiting, which 
is good for the new baby and good for the mom and the family.
    So all that by way of good news, in addition to the 17.6 
million, is it, newly covered by ACA since the enactment. So 
that is all good news.
    On the bad news side, you have been asked, I know, several 
times about the opioid problem, a terribly significant problem 
in our State. We have the ranking now of Pennsylvania being 
third highest in heroin deaths. The Coroners Association--every 
one of our 67 counties has a coroner reporting on how people 
die, and that number has gone up from about 47 a few years ago 
to hundreds of deaths every year, and thousands if you look at 
it over several years.
    So it is a huge issue and a huge problem. I know you have 
been working on it, and the administration's new initiative is 
welcome.
    I guess one subset of this is, I have heard anecdotally 
that child welfare agencies are reporting an increase in foster 
care placements due to the heroin and prescription opioid abuse 
epidemic. How is HHS taking into account the needs of the child 
welfare population as it coordinates its response to this 
epidemic?
    Secretary Burwell. I think in a number of ways. One of the 
most important ways is actually making sure that the mother 
gets into coverage and health care before she has the baby, 
because this is also about the health of the baby and making 
sure that we do everything we can for an addicted mother.
    Actually, in Colorado, I did visit one of the successful 
programs--so it is important to make sure that we have that 
coverage, the coverage that has occurred through the ACA in 
terms of people coming in through the marketplace. But in your 
own State, with the expansion of Medicaid, we believe we are 
going to reach more women.
    So step one is making sure they have the coverage. Step two 
is making sure they are willing to come in.
    I hope that the conversations we are all having publicly 
destigmatize women coming in, because that is the other problem 
that is a barrier. So you do not have health insurance, so you 
cannot pay for it, is a barrier; then, the question of, you are 
stigmatized if you come in.
    So these are some of the issues that we are working on to 
make sure that we start at the beginning of the child's life, 
in terms of a healthy birth and a mother who feels connected to 
that child and is willing to care for it in an appropriate way.
    Senator Casey. I appreciate your work on this.
    My last question is on the complex rehab accessories issue 
that came up at the end of the year, where we legislated. But 
now we are in a situation where for the first 6 months of the 
year, providers will face the same payment difficulties they 
would have faced if we had not passed legislation.
    CMS, as you know better than I, performs these quarterly 
updates. We had some discussion with Dr. Wakefield when she was 
here, but I am just asking that you work with CMS to ensure 
that the congressionally mandated payment change for complex 
rehab accessories is included in the April update.
    Secretary Burwell. We will work to implement that as 
quickly as possible. I think you know this was at the end of 
the year, and I think Administrator Slavitt is planning on 
coming up and having a conversation directly with you about it.
    Senator Casey. Yes.
    Secretary Burwell. So we will follow up in that way.
    Senator Casey. Thank you very much. I appreciate your work.
    The Chairman. Thank you, Senator Casey.
    I think I will take time now to ask my questions, because I 
may have to leave again. I have so many things I am doing today 
that it is hard for me to keep up with it all.
    But welcome, again, and I appreciate the work that you are 
doing down there. It is very meaningful and very difficult. It 
is almost an impossible agency to run. So you are doing well.
    An area of great concern on the topic of executive 
overreach is the Medicare Part D program. There have been 
rumblings that the President may issue an executive order that 
would allow the Federal Government to negotiate prescription 
drug prices in the Medicare Part D program.
    Now, such an executive order would be in violation of the 
law, as the statute explicitly prohibits such interference in 
private negotiations. And despite this fact, I take the 
possibility of an executive order very seriously. I am a strong 
supporter of the biopharmaceutical industry as a source of 
innovation and intellectual property that produces life-saving 
drugs and therapies.
    The Part D program gets these needed drugs to Medicare 
beneficiaries, and we need to keep the program as it was 
originally structured, because it works. Everybody knows that 
Part D is one of the most important things that really works. 
Beneficiaries have a choice of prescription drug plans. Private 
entities negotiate to keep costs down. Overall spending is 
significantly less than originally projected. Beneficiary 
satisfaction is very high. In fact, it has been a tremendous 
success.
    Moreover, allowing the government to, quote, ``negotiate'' 
prices is not a new idea. Congress has considered this policy 
and has chosen against it. The President's budget proposal 
states that it has no budgetary impact. The Congressional 
Budget Office does not see it as a big saver.
    So having said all that, my question is, Secretary Burwell, 
is anyone at HHS working on or has HHS worked with the White 
House on an executive order that would allow the government to 
negotiate prices or on any other changes related to drug 
prices?
    Secretary Burwell. With regard to the issue of drug prices, 
I think you know we are focused on both sides of the issue of 
drugs. It is not just a crisis. It is about innovation, which 
is why we actually brought everyone in for a conversation about 
both of those issues at the end of last year so that we could 
hear from industry, as well as consumers, in terms of the 
issue.
    As we think about it and the steps that we have taken, we 
are focused on both: that innovation as well as that 
affordability.
    I think you know--and certainly Senator Portman raised the 
issue--of deficits and entitlement and mandatory spending, and 
we take that very seriously and are looking for the 
opportunities that we can find in terms of drug prices, because 
it is becoming an increasing percentage of our overall health 
costs. We saw great increases in 2014, the most that we have 
seen in many, many years, in terms of the drug prices. So that 
is why we are focused on the issue.
    The steps that we have taken to date, though, include the 
session that we did, include closing the donut hole, which was 
a part of the ACA, which, at this point, has saved seniors $20 
billion, 10 million seniors. Then the third step that we have 
taken to date is on the issue of trying to provide 
transparency, because we do believe that puts downward pressure 
on prices, and we have created a Medicare----
    The Chairman. Let me interrupt you. I am very concerned 
about this, because I think that they fouled it up on data 
exclusivity with regard to the TPP, the Trans-Pacific 
Partnership. And frankly, if you do not have a data exclusivity 
time of 12 years, which we negotiated--Senator Kennedy and I 
negotiated that, because we know that we have to get enough 
data exclusivity time for the companies to recoup their costs.
    On bio, in the TPP, where we can actually get cures, it 
takes about 15 years and $2 billion, so you need some time to 
be able to recoup that money. With the 5 years that they have 
in that provision, the costs are going to be so high that 
everyone will be screaming, and the bio industry will go down 
the drain, and that is where we are going to find some cures 
that might really save health-care costs over the long run.
    In the case of pharmaceuticals--I am sure if they get that 
5-year figure in the TPP, they will try to do something similar 
with pharmaceuticals, which cost $1 billion and take 15 years 
to develop. This would be problematic, as manufacturers need to 
recoup those funds in order to go on and create newer drugs.
    So I am concerned about it, and I hope that you will weigh 
in, because we have to have some economic sense on these things 
or we will lose the whole pharmaceutical and certainly the 
whole bio industry because of what I consider to be a stupid 
provision in the TPP.
    My time is up. I think Senator Cardin is next.
    Senator Cardin. Thank you, Mr. Chairman.
    Secretary Burwell, thank you for your service. We very much 
appreciate your career service to the public.
    We have talked earlier, but let me just point out that the 
extension of access to emergency psychiatric care, which was 
included in the omnibus--I authored it, along with Senators 
Toomey and Collins--is a logical extension of the program 
through September, but it allows you to extend it through 2019.
    It is revenue-neutral. But we need the guidance, and I know 
you are working on it. It is very important, particularly for 
those from 18 to 64 years of age. So I would just urge you to 
stay focused on that. We think it is critically important for 
access to psychiatric care.
    I also thank you for being willing to look at the pediatric 
oral health care issues. We provided coverage under the 
Affordable Care Act, but the OIG report indicates that far too 
many American children are not getting access to dental care. 
So we need to figure out a strategy to get beyond just 
coverage--make sure coverage is adequate and make sure that 
there is access to qualified dental services.
    I want to follow up on the Psychiatric Care Act, but also 
to deal with the community mental health needs. This past week, 
I had a roundtable discussion at Sheppard Pratt in Baltimore 
with experts on mental health and addiction services.
    We have talked about this several times in the committee: 
the need for greater community access to mental health and 
addiction services. What came out at this meeting was a couple 
of very interesting facts, but the number-one priority still is 
the reimbursement structure that does not take into 
consideration care managers.
    So, if you are a hospital trying to deal with psychiatric 
care--someone comes in to your emergency room--do you really 
know how to triage that person into the most effective, least 
expensive care setting; do you have that capability? If you are 
a qualified health center, are you able to deal with walk-ins 
and referrals, and do you have 24/7 capacity to do this? And 
the reimbursement structure is not terribly friendly toward 
those who understand that they must have those types of 
capacities in their facilities.
    I know that you invited comment last July on how we could 
make the reimbursement structure more effective, and I know 
Congress has taken some actions in regard to programs in 
several States. Can you just update us as to how we are moving 
forward to encourage community-based models for integrated 
collaborative care for mental health services?
    Secretary Burwell. Section 223 allows for the 
implementation of an approach where we are trying to experiment 
both with different payment models and build on the backs of 
the behavioral health centers that are already in communities, 
as well as our Federally Qualified Health Centers, and that is 
a step that we took. Certainly, Senators Stabenow and Blunt and 
Ms. Matsui on the House side have been very engaged in this 
issue. We are ahead of our schedule with regard to 
implementation, as you reflected, in terms of doing the 
demonstrations.
    In the budget that came up on Tuesday, we would like to 
extend those demonstrations so more of those who applied can 
start doing the types of things that you are talking about. So 
we are hopeful that our budget proposal is accepted, and I 
think Senator Stabenow and Senator Blunt are both supportive of 
actually even going beyond what we have in our budget.
    Senator Cardin. I strongly support that, strongly support 
it, and thank you. Thank you for doing that. That is very 
important. My colleagues have been incredible.
    I would just suggest that we need system-wide changes in 
the reimbursement structure so that we can deal with mental 
health. I know you are looking at that, because it is part of, 
I believe, your July inquiry.
    We should take what we have learned--we know that for every 
$1 we spend in these settings, we are going to save $6. Yet, 
the reimbursement structure does not allow creative ways of 
using care managers in communities that may not be part of this 
program. So I just urge us to think broader as to how we can 
make the system work for mental health, because historically it 
has not and today it is still not.
    Secretary Burwell. I think we are hopeful that we can get 
the examples and the models to scale in terms of the changes 
that we will do.
    The other way that what you are talking about can happen is 
through our Accountable Care Organizations. And having visited 
some of those in New York and seeing the progress they make 
with integrated behavioral health care, we are funding those 
both through 223, as well as through our Accountable Care 
Organizations where we are creating models. We need to have the 
analytics.
    Senator Cardin. I am glad that Senator Stabenow showed up, 
because I know I have one of our real champions on this issue--
--
    Secretary Burwell. Yes.
    Senator Cardin. Thank you, Mr. Chairman.
    The Chairman. Senator Scott?
    Senator Scott. Thank you, sir.
    Good morning, Madam Secretary.
    Secretary Burwell. Good morning.
    Senator Scott. It is good to see you again. Just a couple 
questions for you this morning. I happen to be the co-chair of 
the Prescription Drug Abuse Caucus. I know that there is a lot 
of funding throughout the budget for opioid abuse.
    There was one account that was zeroed out. I assume the 
access to recovery account was zeroed out by the 
administration, and my assumption is that there are other 
resources in other parts of the budget, realizing the fact that 
more people are dying because of overdose than from auto 
accidents or gun violence.
    Would you speak to that so that would help some of the 
folks I am hearing from in their concerns?
    Secretary Burwell. Yes. I think this gets to one of the 
topics we have talked a little bit about: making sure there is 
not overlap in programs and that we are reducing that. In the 
proposal and the money that we have asked for in the opioid 
space, there is specifically money around naloxone and Narcan, 
and even last year with existing funding, we have moved those 
moneys out.
    We are trying to work on this on two fronts in terms of 
helping people with the overdose portion of this, and that is 
through our funding and helping communities, but we are also 
working with the private sector to make sure that it is taking 
steps to be able to access it. I think you probably know that 
in a number of States, we see pharmacies, like CVS and 
Walgreens, working with the State to pass regulations to make 
it over-the-counter so that that access can occur not just for 
first responders, but, sadly, sometimes family members need it 
too.
    The other thing that we are doing across the Department in 
this space is, FDA has approved the first nasal naloxone, 
making it easier for regular people to be able to give it to 
their loved one if they need to, so they do not need to do a 
jab.
    Senator Scott. Very good. Thank you. Next question for you: 
I know that you have spent some time in South Carolina, and we 
appreciate that--and you should come back more often. I am sure 
they would like to see you in Charleston.
    In 2013, each State was provided with a CMS liaison to 
contact with questions and issues, and these were removed 
recently and replaced with a generic e-mail account, and it is 
causing some challenges in South Carolina. It seems to be 
nearly impossible, according to the Department of Insurance, 
for States like South Carolina to get quality answers, 
especially answers that are necessary from a timely 
perspective.
    What I have been told by the DOI is that the respondent 
they are talking to many times does not list their name, just 
e-mail contacts, and it is signed basically from the FFM 
response team. When they do identify themselves, it almost 
never includes the individual's e-mail or contact information.
    So the long story short is that it is--from the South 
Carolina DOI--very difficult to have an actual conversation via 
e-mail or by phone with a specific person that leads to an 
immediate response that is clear.
    Secretary Burwell. Two things. One, I will follow up on 
that. The responsiveness and customer service in this space is 
something that is important to our relationships with the DOI. 
I need to find out exactly which part. Does it have to do with 
the FFM, the Federal market?
    Senator Scott. Yes.
    Secretary Burwell. I will follow up in terms of that.
    The other thing is, this does get to the issues of 
resources for CMS. I think you probably know that the question 
of funding for these things--in this particular type of 
service, we cannot use the fees. In our budget this year, fees 
that are coming in from the FFM will far exceed what we are 
asking for in appropriations, which is a good thing, and we are 
happy about it.
    Senator Scott. Yes.
    Secretary Burwell. But there are certain services the fees 
cannot pay for, including some of these. So as you are 
reviewing the budget, if you will look at that----
    But let me follow up specifically on, have we changed 
something and do we need to figure out how people know whom to 
contact? I hear very clearly that you need to be able to follow 
up with someone, is what I am hearing in your question.
    Senator Scott. Exactly. Exactly. Someone as opposed to a 
department; with a specific person, they get a more immediate 
response.
    I assume that in your budget there is some flexibility to 
shuffle some of the resources around.
    Secretary Burwell. We do and we have done so, but I am sure 
you probably know that the funding for CMS over the past few 
years has certainly been an issue that has been a challenge for 
us, and we are hopeful we are at a different place this year.
    Senator Scott. Last question for you: I know you have 
already answered a couple questions about the challenges around 
the CO-OPs. The Federal Government has distributed about $2.4 
billion in loans to 23 CO-OPs around the country. However, 
recently, including in my home State of South Carolina, we have 
seen CO-OP closures, which will likely result in lost coverage, 
higher premiums, and perhaps even higher deductibles.
    In my State alone, about 67,000 South Carolinians could 
lose their insurance. Sadly, South Carolina is not alone. As we 
have heard so far this morning, CO-OPs in 22 of the 23 States 
where they operate are suffering large losses, according to 
last year's results, and there are very few signs that these 
CO-OPs will actually be successful into the future.
    What is your next step?
    Secretary Burwell. With regard to the CO-OPs, in terms of 
our next steps, the consumer is at the center of our strategy 
and our approach to making sure that we take care of those 
consumers. That is why a number of CO-OPs came out before open 
enrollment, and we will continue to monitor the situation with 
the States, which are the lead regulators, I think, as you 
know.
    Having said that, most recently, one of the steps we have 
taken is clarity in our guidance so that the CO-OPs can 
actually seek a broader range of capital for them to have in-
flows as they try to work through any issues they have.
    The consumer is at the center. We support the States, and 
we continue to monitor this closely so that we understand if 
there are changes in the facts that they have given us.
    Senator Scott. Thank you. My time is up, but thank you very 
much.
    The Chairman. Thank you, Senator Scott.
    Senator Schumer, you are next.
    Senator Schumer. Thank you. First, let me thank you, 
Secretary Burwell. I think you are a superlative Secretary. I 
have seen a lot of them in the many years I have been around 
here, and nobody has a greater grip on what is going on, 
understands the policies, understands the practicalities, and 
is able to get things done. So kudos and accolades, at least 
from this Senator, and I know from many more.
    So what I wanted to talk to you about is two things. One is 
the zika virus. I do not know if that has come up so far, but I 
apologize if it has. But your administration--our 
administration--has sent us $1.8 billion in emergency 
supplemental requests for funding to address the zika virus.
    We have a window here. We have time, because the mosquitoes 
that carry it, Aedes aegypti and even a related one that is in 
New York, the Asian tiger mosquito, are not going to come for 
several months yet. So we have time, and we are pretty good if 
we get a handle on intercepting mosquito-borne diseases--
witness what we have done with yellow fever and malaria here in 
the United States.
    So I am glad you have asked for these moneys, and, again, 
to our Republican colleagues, I am going to plead with them not 
to just talk the talk, but walk the walk. You cannot combat 
these crises, whether it is zika or opioids or mental health or 
security in our country, without a lean, effective government. 
The private sector is not going to fight zika, and cutting CDC, 
cutting all the agencies, FDA, makes no sense.
    But what some are trying to do is say that we should not 
have any new moneys; we will use the moneys that were set aside 
for Ebola, which have not all been spent yet, to fight the zika 
virus, which seems to me like robbing Peter to pay Paul. Ebola, 
thank God, is not here now, but it could come back.
    So would you please explain to me why we should not do that 
and rather have a new allocation of money for zika, what the 
moneys for Ebola are being used for, why they are still needed 
even though the Ebola crisis, for the moment, has subsided both 
here and in Africa?
    Secretary Burwell. With regard to our Ebola moneys, there 
are three main pots, and one, in the reports that we send to 
the Congress, is fully obligated, but I think as many of you 
know, much of the money, we are in the middle of negotiating 
contracts for and using.
    The biggest pot of the money that is left from the Ebola, 
is about $500 million, and that has to do with the global 
health security agenda. The Congress gave us that money, and we 
have committed to 17 countries to help and invest over a 5-year 
period, so we spend it wisely. Our moneys go down as their 
moneys go up. We are negotiating plans so that we have 
implementation. We are working on that together, and those 
moneys were set over 5 years to do this.
    The reason that is so important in terms of, why would you 
take that money, is that one of the conversations we did not 
have this year was Middle East Respiratory Syndrome. Last year, 
we had more cases outside of Saudi Arabia than we have ever had 
in history, but we did not talk about it because Korea was able 
to handle it.
    Each year we have something. We have to get these countries 
ready. And actually, zika started in Africa, and we did not 
know. We do not know if they have microcephaly in Africa 
because there was no ability to provide a detection response.
    Senator Schumer. So some of the money goes to stop Ebola 
from spreading to other countries----
    Secretary Burwell. That is another portion.
    Senator Schumer [continuing]. And dealing with it in 
existing countries, because----
    Secretary Burwell. That is another portion.
    Senator Schumer [continuing]. We all know it will come here 
if it is there.
    Secretary Burwell. That is another portion of the money, 
and we know that just recently, in Sierra Leone, a case came 
back. We were able to detect the case, Sierra Leoneans were, 
because they were still swabbing. We are still supporting them. 
So dead bodies they swab and test was how it was found. So it 
did not spread more.
    So we need to get the job done in the three West African 
countries and continue our commitment to prevention of not just 
zika or Ebola, but MERS and other respiratory viruses.
    Senator Schumer. Got it. And is not some of the money also 
to develop a vaccine or some kind of preventative measure?
    Secretary Burwell. That is the other piece of it, and BARDA 
and BioShield and our efforts there, together with the NIH, are 
moving the research.
    Senator Schumer. So we would be robbing Peter to pay Paul. 
We would be making ourselves less safe against Ebola to make us 
safer with zika if we just did not put some new dollars into 
zika and used the Ebola money for that, and you think that 
would be a serious health mistake. Is that fair to say?
    Secretary Burwell. It would be a mistake.
    Senator Schumer. Next, quickly, because I am running out of 
time here: Puerto Rico.
    We have been talking about Puerto Rico and the dire 
situation. As you know, I have sponsored, along with many of my 
colleagues, some of whom are here--Senator Cantwell has played 
a leading role in this--legislation to deal with the problems 
of Puerto Rico, and we need bankruptcy as number one, and 
Senator Hatch has been trying to be very, very helpful on this, 
and we appreciate it.
    But in addition to bankruptcy--in bankruptcy, no money 
should be a substitute for allowing a territory to declare 
bankruptcy. We need other moneys to help, and those would be 
additional.
    My question is, how long do you estimate Puerto Rico's 
current Medicaid allotment will last, and what would happen if 
Congress fails to provide additional money to their Medicaid 
program or, as we have both proposed, to grant them State-like 
treatment?
    Secretary Burwell. We will continue to analyze the 
situation. We worry that things, in terms of that allotment or 
that cap on using it, could happen as soon as this year, and 
that is part of why we have the proposal that we currently have 
in the budget to make sure that we treat Puerto Rico equitably 
in terms of how other Americans are treated with regard to 
Medicaid.
    It is an important financial issue. It is an important 
health issue for the island.
    Senator Schumer. Mr. Chairman, I thank you for that extra 
minute and appreciate your holding this hearing and always your 
courtesies.
    The Chairman. Thank you, Senator Schumer.
    Senator Carper is next. Senator Carper, could you wait just 
a second?
    Senator Carper. Sure.
    The Chairman. Hold that time; put the time back up.
    I have to leave. So let me just thank Secretary Burwell for 
being here, as well as all of our colleagues who have 
participated in this hearing. It is my hope that the issues 
that we have discussed here today can be addressed as we work 
to improve the Nation's health-care system and to ensure that 
taxpayer dollars are used efficiently and effectively. Now, we 
owe that to the dedicated taxpayers and citizens of this great 
country.
    But I would also ask that any written questions for the 
record be submitted by Thursday, February 25, 2016. If we can 
do that and you can answer them as quickly as you can, we would 
appreciate it.
    Sorry to interrupt you, but I wanted to do that.
    Senator Carper. Thank you.
    Madam Secretary, welcome. It is great to see you, great to 
talk with you this week. Your dad and my mom spent some time in 
nursing home care, my mom for dementia, and I think your dad as 
well.
    I shared with you the other day that on Monday, I visited 
Presbyterian Village Nursing Home, just outside of Dover, DE--
lovely facility--and they are doing something I thought was 
very encouraging. They have stopped prescribing--I will call 
them antipsychotic medications. I am used to going in nursing 
homes and seeing particularly the dementia patients, they are 
drugged out. They do not know who they are, where they are, are 
not very responsive.
    There are a lot of people in this nursing home in their 90s 
and even in their 100s. They have a fitness center there, they 
are doing yoga, but they do not take those medicines. They 
reported to me on the number of falls. The number of falls now 
as compared to what it used to be, it is dramatically reduced. 
I think they have currently, of their long-term residents, zero 
percent of them on antipsychotic drugs.
    On a personal level, but really on a professional level, I 
just want to know if the Department of Health and Human 
Services, with everything else you are doing, if this is 
something that you are thinking about?
    We have worked on this issue with respect to trying to stop 
or at least reduce the prescribing of these mind-altering drugs 
for foster kids. That has been an important issue. This is 
something for your grandparents or great-grandparents. I think 
they are on to something at Westminster Village.
    Any thoughts?
    Secretary Burwell. I think it aligns very much with what we 
are trying to do to get an educated, empowered, engaged 
consumer at the center of their care. And when we pay people 
for actually the outcome instead of paying for fee-for-service 
and the transaction, that is, I think, when we get to that.
    That is when, in a place like that, on a regular basis, 
there is a meeting of the caregivers with the family to have 
the conversations about these things, to talk about them so you 
can reduce those medications. So I think it is all part of the 
delivery system reform that we are doing and the shifting of 
the payment system in Medicare.
    I think the other place where we will be pushing on this 
kind of specific issue is as we try, through our Innovation 
Center, to do our experiments in home-based care, which Senator 
Wyden certainly has spent a lot of time promoting.
    It is a lot about payment incentive as well. Certainly, 
opioids are a separate category, but the type of drugs you are 
talking about, I think have a lot to do with how we pay 
physicians to care for people and how we pay providers to care 
for people. It is about the quality of their care, defining 
that and defining that the outcome is value, not volume, not 
how many pills you prescribe, not how much they are taking, but 
what the situation is for the individual.
    Senator Carper. Good. Thank you. For us, this one is 
personal. So I very much appreciate what you just said.
    During the last Congress, I worked with Dr. Coburn and with 
you and some of your colleagues in the administration on issues 
including improper payments and something called the PRIME Act, 
which dealt with preventing and reducing improper Medicare and 
Medicaid expenditures. Over the last two Congresses, we passed 
bits and pieces, but we have now enacted, I think, the entire 
PRIME Act, which is just a wonderful thing, I believe.
    I am going to ask you, for the record, to respond to me 
about the implementation of the new law, which has been 
implemented in pieces, and how we are doing in this effort to 
curb waste and fraud, but not here at this forum; we just do 
not have time.
    I would ask, though, that on the reducing opioid and pain 
killer additions, as I understand it, the folks who are, in 
some cases, physician assistants, nurse practitioners, are able 
to prescribe medication for opioid addiction to help increase 
the number of health-care providers who could help us address 
this epidemic.
    Could you just talk about--I think there is a pilot, and I 
may be confused on this, but I think there is a pilot program 
that would focus on this area, allowing them, not throughout 
the country to prescribe medicines for opioid addiction, but to 
do it on a pilot.
    The question is, is that something we ought to do on a 
pilot or is it something that we should allow them to do 
nationwide? Do we need the pilot, I guess is my question?
    Secretary Burwell. With regard to the issue of medication-
assisted treatment and broadening the number of prescribers 
that can do it, we actually have a proposal in our budget that 
would allow broadening.
    I think there are two separate issues. There is the issue 
of broader medication-assisted treatment, and there are 
different categories of it. One particular issue is 
buprenorphine, which is a drug that has limits and caps. Right 
now we are in the middle of reviewing that and using our 
administrative authorities to raise those caps. That drug, 
distinct from some others--there are concerns that it may have 
greater diversion. So we want to make sure that, as we are 
creating access to it, we do it in ways so that we do not have 
diversion.
    So I think there are two different categories as we think 
about when we scale things. Where we have the evidence that we 
are not going to create an unintended consequence, we move more 
quickly and more broadly. In the cases where we need some more 
evidence to make sure that there are reasonable questions being 
asked, we would do that in smaller settings.
    Senator Carper. Thanks. Thanks for your leadership. It is 
great to see you. Thanks.
    Senator Wyden [presiding]. Senator Stabenow?
    Senator Stabenow. Thank you very much.
    Secretary Burwell, obviously we thank you for all your 
wonderful leadership. I do want to follow up on behavioral 
health, mental health, and substance abuse. But before doing 
that, I want to thank you for all of the efforts of your 
department and the administration in helping us with the 
incredible public health emergency in Flint.
    The person you have put on the ground, Dr. Nicole Lurie, is 
really tremendous, and so is the work that is going on there. I 
know you will be going next week to Flint. So we appreciate 
your personal attention.
    As you know, we have a community of 100,000 people who, 
through no fault of their own, have seen their water system 
poisoned and basically, in many parts of it, destroyed because 
of a lack of corrosion treatment before switching to the poor 
quality Flint River water, and up to 9,000 of those are 
children under the age of 6 who are now exposed. Some of the 
houses have lead levels as high as a toxic waste dump. So this 
is extremely serious. We are still hopeful. We have had 
difficulty coming together and getting bipartisan support here 
to help rebuild the pipes and so on, but we are still working 
and still hopeful we will be able to come together and do 
something. But thank you for your help.
    I do want to talk about, as you know, another passion of 
mine we spent a lot of time on, and that is implementing what 
Senator Blunt and I were able to get passed in the new law to 
create the structure so that we are not just funding mental 
health and substance abuse services from grants that ebb and 
flow up and down, but implementing a structural change in 
payments that recognizes when a behavioral health specialist, a 
psychiatrist, psychologist, social worker, does work that meets 
quality standards, that they should be reimbursed like we 
reimburse other health professionals under a Federally 
Qualified Health Center.
    We have known actually since President Kennedy passed the 
Community Mental Health Act over 50 years ago, that we needed a 
structure in place so that we were providing comprehensive 
health care in the community. That is really the final gap: 
mental health parity.
    So, as you know, under the direction of legislation passed 
by the Congress, we now have qualified community behavioral 
health clinics and definitions of what quality is, like we do 
for FQHCs, Federally Qualified Health Centers.
    The question is, how do we get that available in every 
community in every State? So the Congress was willing to 
provide enough funding for eight States, with planning grants 
for States interested to see if they could meet those 
qualifications in order to apply to be one of the eight States, 
under your direction and SAMHSA and all of the wonderful folks 
who have been involved in your whole team: HHS, CMS, everyone.
    You have the program ready to go, and 24 States have gotten 
planning grants. Twenty-four Governors, 24 States have said, 
``We want to do this.'' We are planning how we meet those 
quality standards, and we currently only can accommodate eight 
States, even though to do anything else we want to do--opioids, 
mental health, and so on--it all comes back in the end to 
having community services, so people are not going to jail or 
the emergency room at the hospital. They are getting the 
service in the community.
    So first, I noticed that in the President's budget, you 
expand the number of States from the eight we are talking about 
to 14. There are 24 States that are getting ready to go.
    I wonder if you might speak to what is our joint effort, 
Senator Blunt and I, a bipartisan effort to actually allow 
every State that is working to be ready to go, to have the 
opportunity to provide the resources so that we really have 
mental health and substance abuse services in the community.
    Secretary Burwell. Thank you for your leadership in this 
space, Senator. You know, you and I have spent time, Senator 
Blunt and I have spent time, through your leadership, moving 
forward on that establishment of the quality standards and then 
the implementation, because it is about the infrastructure to 
implement, and that is why it is so important in these 
communities across the country that lack access. So many 
communities across our Nation actually lack basic access to 
psychologists, psychiatrists, or other behavioral health 
professionals, and we do have an infrastructure in place.
    So now what we need to do is take those quality standards 
and make sure we pay, and that is what I think we believe that 
the eight demonstrations that we are doing are going to do. So 
we believe it is taking that step, and our budget is proposing 
that we do more, because we think that is the right thing to 
do, to build on this, to get that transitioned to where we 
finally treat behavioral health issues on par.
    It is not just about saying we are going to do it, it is 
about having providers to do it and quality measures to pay 
for. So this is the direction we are pushing hard in. I think 
you know we are meeting our statutory deadlines in terms of 
some of this work, because we believe in it strongly.
    Senator Stabenow. Yes. And I want to just take another 
minute to thank you for doing that, because you are working 
hard to meet those standards, and you have proposed expanding 
that.
    We want to take it to every State that is interested and, 
frankly, listen to the sheriffs across the country who are 
tired of having people in jail who ought to be receiving mental 
health or substance abuse services, or hospital administrators 
who are treating people.
    I will never forget talking to the Cook County Sheriff, 
whose director of his jail is a psychiatrist. And when we ask 
why, it is because over a third of the people in his jail need 
psychiatric help.
    So, under the quality standards that we have now put in 
place, 24-hour emergency psychiatric help would be required as 
part of this quality certification, and hopefully Congress this 
year will decide to give the 24 States who have stepped forward 
the opportunity to put services in place.
    Secretary Burwell. We look forward to working with you on 
it.
    Senator Wyden. Senator Warner?
    Senator Warner. Thank you, Mr. Chairman.
    Thank you, Secretary Burwell. Thank you for your 
responsiveness. If I can get my questions out quickly, you may 
be done for the day. I have a three-piece statement. One, a 
thank you; secondly, a concern; and third, a question, and I 
will try to make sure I give you time to respond.
    On the thank you, an issue that we have talked about a 
number of times is the Gabriella Miller Kids First Act, which 
deals with pediatric cancer and celebrates the life story of an 
extraordinary young woman from Leesburg, VA, who passed, but 
advocated for research in pediatric cancer. I was very glad to 
see that it was fully funded in the President's budget 
proposal. I know we had to work through some things to get that 
done, and I am grateful for that.
    I was also glad that the President's Cancer Moonshot 
included elements targeted at pediatric cancer, since pediatric 
cancer is so different from adult cancer. So thank you for 
that.
    On the concern issue--and this is just to put it on your 
radar screen; we are working with CMS--we know that due to 
budgetary constraints, a number of the community-based care 
transition programs that initially folks thought might last for 
5 years have been cut to 4 years.
    We have a successful program in Virginia under the aegis of 
Bay Aging that does this coordinated transition care. 
Unfortunately, they were cut back without being able to make 
the full transition to sustainability.
    We are working with CMS, and this is a concern, but I am 
not asking you to do a one-off here. We are working with CMS; 
they have been cooperative. But when we see successful programs 
that can and should make the transition to economic viability--
I think we have one here--I, again, would just appreciate the 
collaboration and cooperation from CMS to try to make this a 
successful program and make this transition.
    Finally, a subject, again, that we have talked about at 
times, and it is one I think, candidly, that the American 
public is ahead of most of our elected officials on, and that 
is around care planning and end-of-life issues. I think that we 
still remain the only industrial nation in the world that has 
not had this kind of adult conversation about care planning, 
about trying to make sure that issues around end-of-life are 
dealt with respectfully, recognizing that this is not about 
limiting choices, but it is about expanding choices.
    I was pleased to see that CMS introduced a payment form for 
physicians to have those kind of conversations about advanced 
directives and POLST * and the other legal entities that come 
out of those conversations. Those conversations should include 
family members, loved ones, religious advisors.
---------------------------------------------------------------------------
    * Physician Orders for Life-Sustaining Treatment form.
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    Senator Isakson and I have been working on this for some 
time, and we are gaining broader-based bipartisan support, and 
there is not a member of the Senate whom I have talked to who 
does not have a personal story. Mine was that my mom had 
Alzheimer's for 11 years, 9 years of which she did not speak, 
and I was a relatively well-informed citizen, yet we did not 
have all those conversations before it was too late.
    We are working on it. I guess I would just like to assure 
you of our commitment that we will continue to work with your 
staff on the care planning codes, how we look at more 
wraparound services. We are trying to work to make sure that 
these types of advanced directives can actually travel across 
State lines, and I know this is something Senator Wyden has 
been engaged and involved in, as well. When mom or dad or aunts 
and uncles move, we need to make sure that those documents 
travel with them, built into their EMR.
    I guess I would just like your comments in this space and, 
again, acknowledging that I think, for the most part, elected 
officials have to move beyond kind of some of the horrific 
language that may have been used 6 or 7 years ago. This is a 
part of everyone's life, and it needs to be dealt with with 
respect and dealt with appropriately. My hope is with the Care 
Planning Act, we actually may get this done.
    So, Secretary Burwell, if you would like to make a couple 
of comments on that----
    Secretary Burwell. First, thank you for your leadership, 
because your leadership and Senator Isakson's and others', it 
helped to create this space where we could go forward and make 
the changes that we have made in terms of paying, and we think 
that is an incredibly important first step.
    But we know it is a first step, and now the question is, 
how do you implement this so this is useful to the people and 
meets the goals and objectives that I know we share?
    So we are going to continue to work in that space. We 
welcome the comments. We welcome continuing to work with you on 
this issue. We did this because we believe it is an important 
change and a change that is about quality of care for people 
across this country and their families. So we take seriously 
the next steps that we need to do, and we look forward to 
working with you on that. I think being able to pay makes a 
very big difference.
    Senator Warner. And I would simply say, Senator Wyden, not 
only being able to pay but to have that conversation, and also 
to recognize that people's wishes ought to be respected.
    It is, again, I know, an issue that we have talked about, 
and you have been a leader on this for many years. But my sense 
is, on the good side, that this is an issue where the American 
people are, candidly, ahead of their elected officials, and 
there is not a single member in this body who, if you sit down 
and have an honest conversation with them, has not had some 
experience either with a family member or friend. And it just 
breaks your heart sometimes when you see--I recall one 
Virginian who had to go twice, as a daughter, to make sure that 
her mother's wishes at 102 of not being resuscitated when she 
had chosen not to be were honored.
    I, again, appreciate the Secretary's sensitivity on this 
issue. It is a hard issue to talk about, but it is one that I 
think, in America, we need to address. And it is not about 
limiting choices, it is about expanding choices.
    Thank you.
    Senator Wyden. Thank you, Senator Warner.
    It is striking. I was going to talk to Secretary Burwell 
just for a few minutes about the future, and how appropriate it 
is that Senator Warner, who, along with Senator Isakson, has 
really been in the vanguard of laying out some new policies to 
expand choices for end-of-life care, raised this issue.
    One of the areas I am very proud of took years, and is 
now--as a result of the Secretary's good work--a demonstration 
finally put in place called Medicare Care Choices. So for the 
first time, older people participating in this demo do not have 
to give up the prospect of curative care in order to receive 
their hospice benefit. I have been hearing about that since the 
days when I had a full head of hair and rugged good looks and 
was director of the Gray Panthers.
    Senator Warner. Mr. Chairman, was that back in the early 
part of the 20th century? [Laughter.]
    Senator Wyden. It is impossible to calculate. But the point 
is, what Senator Warner has been talking about is creating more 
choices. This is not about Washington, DC producing another 
Federal cookie-cutter program where you are going to have to do 
A, B, C, and D. What Senator Warner is talking about is, the 
centerpiece of end-of-life care should be about empowering 
patients and their families, and it is high time.
    Senator Warner, you and I and Senator Isakson have been 
prosecuting this case, and I am very appreciative of it. 
Medicare Care Choices starts us down the path, but Senator 
Warner is absolutely right about several of the next steps, and 
I am with you.
    Secretary Burwell, one of the assessments I would make as 
we wrap up is that, because of the good work that you have been 
doing, you and your colleagues, America is not going to turn 
back the clock. America is not going to turn back the clock on 
the Affordable Care Act.
    You have talked about the increased enrollment. I am 
particularly pleased that you are making this point that the 
heart of the ACA, right at the center of it, is making sure 
that people do not get discriminated against for preexisting 
conditions.
    I always thought that as long as you allowed that, which 
was the history of American health care for just eons, you 
basically had health care in America for the healthy and the 
wealthy, because if you had a preexisting condition and you 
were wealthy, you could pay for it. If you did not have one at 
all, you were in clover.
    So you all have, I think, now made it clear that the 
Affordable Care Act is not going to be repealed. We are not 
going to go back to the days when you could beat the stuffing 
out of people who had a preexisting condition, and I think it 
is appropriate to talk about the future.
    So I am going to spend just a couple of minutes doing that. 
First, Newt Gingrich and Tom Daschle wrote an op-ed piece here 
a few days ago. I do not think you see that happen every single 
day: the past Republican Speaker, the past Democratic Leader 
writing an op-ed piece, and they said, let us have a bigger 
role for the States, let us have a bigger role for the States 
in the Affordable Care Act.
    They had a variety of ideas: pulling the Governors together 
to look at approaches, making sure that the various funding 
sources were more integrated. I guess in the lingo of your 
agency, those are funding streams, but to me, it is taking the 
various funds and trying to find a way to coordinate them.
    What do you think about that? What are our opportunities 
for--and, as I ask the question, I want to be clear, this is 
not talking about anybody trying to duck the coverage 
requirements and the consumer protections and the law. This is 
about whether people across the political spectrum can figure 
out how to test various approaches at the State level.
    What are the possibilities?
    Secretary Burwell. I think that there are possibilities 
across a number of different places, in terms of where the 
authorities lie for us to work with States to do the things 
that they want.
    We actually earlier spoke with Senator Cantwell about the 
basic health program and the steps that New York took in terms 
of how they wanted to approach that. And as you mentioned at 
the end, one of the things I think that is fundamental and so 
important is that there is a basic baseline with regard to what 
the benefits need to look like in terms of making sure that the 
access that has been gained is not lost and that we are also 
watching the finances in terms of the Federal Government.
    So when we think about that, there are ways, like the basic 
health plan, where progress has been made, and there are 
different alternatives and approaches to that.
    Also, I would just highlight that the Governor of Alabama 
this week announced that he is working with us and has come to 
closure on a waiver that will do regional care organizations, 
like Accountable Care Organizations. He has created an approach 
in his State that is innovative and is working toward the kind 
of care that we were just talking about at end-of-life: an 
educated, empowered, and engaged consumer at the center of 
their care throughout their entire life, and those are the 
kinds of things we want to work with.
    The constraints, in terms of where the boundaries are, have 
to do with affordability and access. With regard to 1332, we 
have put out guidelines that articulate the standards that have 
been met. We have not put further constraints on because we 
want to hear innovative ideas.
    Senator Wyden. The second question I would just like to 
touch on is a committee project. I am very appreciative of 
Chairman Hatch's interest in this, and he knows that I have 
been interested in this for years.
    Medicare of 2016 is not the Medicare of 1965. The Medicare 
of 1965 was, people stayed in hospitals a lot longer, and if 
you hurt your ankle and it was not a really serious injury, it 
was Part B of Medicare. If it was really serious, you were in a 
hospital for a few days.
    That is not Medicare today. Medicare today is cancer, 
diabetes, heart disease, strokes. That is most of the spending. 
And we now have a task force, which, fortunately, is led by 
Senator Isakson and Senator Warner, with their interest in 
these issues, and it is really stunning what you come up with 
when you look at this.
    After seniors, particularly in areas where you do not have 
Medicare Advantage, get that free physical--thank you, 
Affordable Care Act--so often their care or kind of the non-
system that exists just sort of leads them off the rails, and 
they end up in a hospital emergency room and when they are 
about to be discharged, nobody even knows who to send a record 
to, because the care is so fragmented and splintered.
    You, in putting together the HHS budget, obviously, have 
taken a look at this whole question of chronic illness. What do 
you think is ahead there?
    Secretary Burwell. I think as you are reflecting, with 
chronic care, both in terms of quality and in terms of costs, 
we know that about 80 percent of our total health care costs 
come in those chronic situations, whether that is diabetes, 
heart disease, other things. So both from a quality-of-life 
perspective and a cost perspective, taking these issues on is 
important.
    I think the other thing is, as we think through the 
strategic approach that then guides all the tools and levers 
that we have from a policy and payment perspective, at the 
center of that is more integrated care.
    We need to change the way that we deliver care in the 
country, and we are on a pathway to do that, whether that is in 
prevention, as you highlighted, the importance of the 
preventative care services that are required without additional 
cost through the Affordable Care Act, or making sure that you 
have a primary care home, where that person is responsible for 
making sure that the pieces and parts of your care are 
connected in a way that serves you.
    I think that connects to a point we discussed earlier, 
which is making sure that we are paying for value, not volume. 
So we are paying for the outcome of your health care, and 
whether that is that prevention up front or when you do have 
something, making sure we get the outcome you want, connecting 
those things together. And that is why the payment system is a 
very important part of the tools we have at hand to drive this 
change, in terms of care that is more integrated and focused on 
the individual with them engaged as part of that care, in terms 
of the choices we were discussing at the end of life, but well 
before then, in terms of your everyday care.
    Senator Wyden. I can tell you that, of course, the popular 
wisdom is that this is an election year and nothing is going to 
get done and the like, but I have been very appreciative of 
Chairman Hatch's interest in this, and he is telling us we are 
supposed to pull out all the stops to pull together a 
bipartisan bill to set what I think are reasonable principles 
we ought to work around.
    So buckle up for that one. We are going to push very hard 
to advance that this year.
    Let me turn briefly to some questions with respect to some 
of the other issues that are within your jurisdiction.
    First, I want to make sure that we formally acknowledge the 
improvements to the TANF program, the improvements that you all 
have made. TANF, of course, again, outside of Washington, is 
public assistance. I think we have made some real progress, 
most recently in the tax bill in December with respect to the 
Earned Income Tax Credit. That is a very substantial victory.
    We have more to do to help struggling parents find work, 
and I think you all have some promising proposals. So that is 
as much a reflection on your good work as a question.
    With respect to foster care, I thought that--and I just 
heard about it from the staff--Senator Casey made a very good 
point with respect to the new spike in foster care, and 
certainly a factor in that is the opioid epidemic.
    Chairman Hatch and I have spent the better part of the last 
year working on a proposal called Family First that would allow 
States to use their foster care dollars on programs that we 
know to be effective--drug treatment or mental health--and help 
prevent the need for foster care by keeping families together.
    I think the premise is that these types of programs not 
only save money for the overall system, but they also improve 
the health and well-being of vulnerable youngsters.
    Now, you all have a similar proposal, as I understand it, 
perhaps not with the same role for substance abuse treatment 
programs but as a foster care prevention tool.
    Now, you pointed out there is certainly a role here for 
Medicaid, and that is important. Chairman Hatch and I feel 
strongly that child welfare foster care dollars can also be 
used more efficiently in this space, and I would be interested 
in whether you share that view.
    Secretary Burwell. I think you know that we do share the 
view of trying to make sure we are doing the things so that 
children can stay in their home setting as much as possible, as 
long as that is safe and appropriate--there are ways to 
encourage that--and many of our proposals do that.
    So we welcome the opportunity to talk about what are the 
key ways that you do that in terms of supporting a parent or 
parents so that they are able to care for that child 
appropriately and then the question of where the funding stream 
is. We welcome that conversation.
    Senator Wyden. We started the vote on a bill that is in 
this committee's jurisdiction, the Trade Enforcement Act, and I 
am just going to leave you with one last thought.
    We are going to be relying on your counsel and your 
expertise a whole lot during this remaining year, and what I 
have always sensed about your agency and handling the 
responsibilities there is that doing your job well is a contact 
sport.
    I admit that I went to school on a basketball scholarship, 
so that is kind of my world, but I see you constantly reaching 
out to legislators, to State officials, to the advocates, and 
these are people who often do not have the power and clout. I 
just want you to know I really appreciate that, because I think 
you are kind of writing a sort of manual for how you ought to 
do this job at this incredibly important agency, which is sort 
of the people's agency for kids and seniors and the disabled.
    I wish there was more time to get into some additional 
issues, but we are going to come back to you on some big 
questions, because I know you and I have talked briefly about 
the 18-month investigation that Senator Grassley and I did into 
the hepatitis C drugs. There is a piece out this morning that 
indicates that the States are rationing hepatitis C drugs, that 
they cannot afford to take care of people, and, by the way, 
when you ration hepatitis C drugs, people get sicker and sicker 
and have these very serious liver illnesses, which cost even 
more money.
    So we are having problems today handling just a small 
percentage of those who have hepatitis C, and we are likely to 
end up with bigger expenses as a result of care being rationed.
    I think, and it is a question we are going to start 
examining here, we are on the cusp in the United States of 
having a policy that says we are going to have spectacular 
cures for illnesses--and the hepatitis C drugs are cures, 
talking about Sovaldi and Harvoni--and we are going to have 
spectacular cures I suspect for diabetes, a variety of cancers, 
and the like. The question will be, will Americans be able to 
afford to get those cures, and that is going to certainly be a 
debate that would not be for the fainthearted.
    So I am really glad that we are going to get to have you 
for close to an additional year, and I so appreciate 
particularly the way you constantly come back to pulling people 
together. You do not get this job done well and come up with 
policies that pick up bipartisan support by osmosis. You get it 
done because you are constantly reaching out to people and 
saying, ``Look.'' Bipartisanship is not about accepting each 
other's bad ideas. Bipartisanship is about taking good ideas, 
and I think you handle that very well.
    I think Chairman Hatch indicated we have some colleagues 
who may ask additional questions for the record.
    With that, the Finance Committee is adjourned.
    [Whereupon, at 12:10 p.m., the hearing was concluded.]

                            A P P E N D I X

              Additional Material Submitted for the Record

                              ----------                              


     Prepared Statement of Hon. Sylvia Mathews Burwell, Secretary, 
                Department of Health and Human Services
    Chairman Hatch, Ranking Member Wyden, and Members of the Committee, 
thank you for the opportunity to discuss the President's FY 2017 Budget 
for the Department of Health and Human Services (HHS). Last legislative 
session, this Committee took historic steps to pass the bipartisan 
Medicare Access and CHIP Reauthorization Act of 2015. We thank you for 
your leadership on that important issue and look forward to working 
with you on implementation in the year ahead.

    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 health care 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 convenedstate leaders in our fight 
against prescription drug abuse 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 FY 2017 Budget for HHS builds on this progress 
through critical investments in health care, 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, 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 FY 2017 Budget advances access, affordability, and quality in 
our nation's health care system--goals that we share with Congress and 
this Committee. Through targeted investments, the Budget expands access 
to care, particularly for rural and underserved populations, 
strengthens services for American Indians and Alaska Natives, and 
supports primary and preventive care.

    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 FY 
2019 to ensure comprehensive and affordable coverage for beneficiaries 
as well as budget stability for states. We look forward to working with 
Congress to extend this program for the millions of children who depend 
upon it.

    Investing in Health Centers. For 50 years, health centers have 
delivered comprehensive, high-quality, cost-effective primary health 
care to patients regardless of their ability to pay. Today, more than 
1,300 health centers operate over 9,000 sites and provide health care 
services to 1 in 14 people in the United States, including at 52 
centers in Utah and 216 centers in Oregon. 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 over 27 
million patients across the country in FY 2017.

    Bolstering the Nation's Health Care Workforce. The Budget includes 
investments of nearly $14 billion over 10 years in our Nation's health 
care 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 requestincludes 
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. We know this is a priority for 
many of you on this Committee.

    Strengthening Health Outcomes in Indian Country. The FY 2017 Budget 
continues the Administration's commitment to support and strengthen 
services in Indian Country. The Budget funds the Indian Health Service 
(IHS) at $6.6 billion, an increase of $402 million over FY 2016, to 
bolster programs that serve over 2 million American Indians and Alaska 
Natives at over 650 health care facilities across the United States. 
The Budget includes $67 million in new investments in the critical area 
of behavioral health to address high rates of mental illness, substance 
abuse, and suicide in tribal communities. The Budget also fully funds 
contract support costs, which provides critical overhead funding to 
tribes who operate facilities under self-determination and self-
governance agreements.

    Strengthening Health Programs in the Territories. 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.
                   health care delivery system reform
    At HHS, we are focused on moving towards a health care 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 health care 
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% in 
alternative payment models by the end of 2016, and 50% 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 health care, engaging patients more fully in decision-making, 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 ofMedicare 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.

    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 patient 
harms 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 decision making, 
and consistently uses high quality evidence to provide safe and high 
quality care for all.

    Reducing the Cost of Prescription Drugs in Medicaid and Medicare. 
Nationally, prescription drug spending growth has accelerated to its 
highest rate since 2002 and is projected to drive overall healthcare 
cost growth. New therapies and cures change lives, but too many 
Americans struggle to afford the medications they need. The Department 
is focused on improving patient access to affordable prescription 
drugs, developing innovative purchasing strategies, and incorporating 
delivery system reform concepts like value- and outcome-based models 
into drug purchasing arrangements. The Budget includes a number of 
proposals, including Medicare Part D negotiation, aimed at improving 
access to necessary treatments and increasing the value that Americans 
are getting from their medications, while continuing to encourage 
important and lifesaving innovations.

    Improving Health Care for Dual-Eligible Beneficiaries. As members 
of this Committee are aware, people enrolled in both Medicaid and 
Medicare have complex and often costly health care needs. The Budget 
includes legislative proposals to improve access for dual-eligible 
beneficiaries, while decreasing overlap and inefficiencies that 
currently exist between the two payers.
                    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 Drug Abuse. 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 FY 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 2-
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 FY 2017 and FY 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 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. To best prepare 
communities and first responders, the Budget includes a total of $22 
million for programs that support the use of naloxone--a life-saving 
drug. Among other critical programs, the Budget invests 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 
health care, 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 health care systems work 
for everyone. A portion of the two-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 under 
this Committee's leadership.

    Combating Antibiotic-Resistant Bacteria. The emergence of 
antibiotic-resistant bacteria continues to be a significant public 
health concern. The FY 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 ampleased 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 more than $1.8 billion in emergency 
funding, including $1.48 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 health care 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 
countries 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 FY 2016 and FY 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 as well as 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, 100,000 of which are refugees, consistent with the 
Administration's commitment to admitting at least 100,000 refugees in 
FY 2017.

    HHS is legally required to provide care and custody to all 
unaccompanied children apprehended by immigration authorities until 
they are released to an appropriate sponsor to care for them while 
their immigration cases are processed. Based upon the recent increase 
in unaccompanied children apprehended at the Southwest border, ACF is 
taking prudent steps to add temporary capacity so that we are 
adequately prepared. To ensure that HHS can provide care for all 
unaccompanied children in FY 2017, the Budget includes the same amount 
of total base resources available in FY 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 newlyauthorized Preschool Development 
Grant program; and to invest in voluntary, evidence-based home visiting 
programs that have long-lasting, positive impacts on child development.

    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 FY 
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 FY 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 
FY 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.

    Modernizing the Approach for Addressing Poverty. Finally, the 
Budget seeks to strengthen the nation's safety net to meet our 21st 
century poverty challenges. A total of 15.5 million children lived in 
poverty in 2014, a staggering number that translates into lost 
opportunity, productivity, quality of life, and lifespan. Twenty years 
after creating the Temporary Assistance for Needy Families (TANF) 
program, funds are proposed to reform and strengthen this critical 
program that serves approximately 3 million children per month. The 
Budget increases funding for TANF to help offset some of the erosion to 
the block grant, while laying out the basic principles for reform--
including moving towards a stronger accountability framework for states 
coupled with increased flexibility, ensuring better targeting of TANF 
funds, and creating a renewed focus on reducing child poverty. We look 
forward to working with lawmakers to strengthen the program's 
effectiveness in accomplishing its goals.

    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 FY 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 FY 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% in the last 60 
years. Cancer death rates are now falling 1-2% per year; each 1% drop 
saves approximately $500 billion. Breakthroughs in HIV therapies enable 
people in their 20's to live a full life span. The FY 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 FY 17. 
The Budget fully funds the Health Care Fraud and Abuse Control (HCFAC) 
discretionary cap adjustment. In FY 14 alone the HCFAC program returned 
over $3.3 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.

                                 ______
                                 
   Questions Submitted for the Record to Hon. Sylvia Mathews Burwell
               Questions Submitted by Hon. Orrin G. Hatch
                           program integrity
    Question. In a recent response to this committee's inquiries into 
the recovery audit program, CMS indicated they were shifting the focus 
of the recovery audit program. The new focus will be on providers who 
have high error rates. With $60 billion misspent last year alone, it 
seems that you would want your auditors to recover monies wherever they 
are in jeopardy. That certainly was what the Tax Relief and Health Care 
Act of 2006 envisioned. I would like to know how recovery auditing 
works in the commercial sector and why we are not applying those 
practices to the Medicare recovery auditors as TRHCA envisioned.

    Answer. Senator, I know that you and this committee care deeply 
about program integrity. I agree that good stewardship of taxpayer 
dollars is important, and that is why I consider it a top priority as 
Secretary. From FY 2010-2014, RACs returned $7.1 billion to the 
Medicare Trust Funds. The Medicare Fee-for-Service Recovery Audit 
Program is a valuable tool, and we believe ongoing enhancements to the 
program can allow CMS to use Recovery Auditors to more effectively 
recover and address improper payments by focusing on the highest risk 
providers. At the same time, these enhancements will increase 
transparency, improve provider fairness, and lead to better provider 
and Recovery Auditor communication. The Recovery Auditing Program uses 
techniques similar to commercial sector recovery auditing principles, 
such as using data analysis to identify improperly paid claims, 
requesting medical documentation to help identify possible improper 
payments, affording debtors a dispute or appeals process, and recovery/
collection processes payments. In addition, also similar to commercial 
sector recovery auditing, Recovery Auditors must pay back contingency 
fees for review determinations that are overturned on appeal and are 
paid on a contingency fee basis. As part of the procurement for the 
next Recovery Auditor contractors, CMS performed several rounds of 
market research and found that requirements vary among commercial 
sector recovery auditors.

    CMS balances its responsibility to protect the Medicare Trust Funds 
with its responsibility to protect providers from inappropriate claim 
denials that impede access to patient care. To that end, CMS has 
established controls over our contractors' performance, such as 
approving all audit topics prior to widespread review, and independent 
validation of claim reviews to determine contractor accuracy.

    Question. I'd also like to know how you intend to define what a 
high error rate is; is it 10%? We already have an error rate for the 
Medicare program that is over 12% and it is costing us $60 billion 
every year in waste. How you will identify providers with high error 
rates and why do you think having recovery auditors review these error 
prone providers is appropriate rather than some of the other actions 
and tools Congress has given you?

    Answer. CMS plans to adjust a provider's additional documentation 
request (ADR) limit by comparing a provider's own claim denial rate to 
CMS' national target improper payment rate. A provider's claim denial 
rate will be calculated by the number of claims found by the Recovery 
Auditor to be improperly paid, divided by the number of claims reviewed 
by the Recovery Auditor during a particular time period. This will 
allow for broader reviews of claims in these areas, and for CMS to 
better target reviews of providers that pose the greatest risk to the 
Medicare program. Additionally, in those cases where CMS specifically 
directs the Recovery Auditors to review a specific topic or provider, 
the ADR limit will not apply.

    CMS is continuously working to improve collaboration between 
auditing contractors to promote accurate and efficient auditing of 
Medicare claims while reducing provider burden and ensuring beneficiary 
access to health care/health services. CMS is planning to share the 
details on this new, risk-based approach to adjusting ADR limits soon.

    Question. If recovery auditors are severely limited in the number 
of claims they are allowed to review for inpatients claims, what other 
areas has CMS approved them to review? What are CMS's plans for 
broadening the types of improper payments that can be reviewed and 
targeted for recovery?

    Answer. During the time period that patient status reviews were 
statutorily prohibited, CMS has continued to allow the review of 
inpatient claims for issues not related to the inpatient/outpatient 
status of the patient, such as to determine if the claim was coded 
correctly. Additionally, during this time, CMS approved a number of 
audit topics for various provider types, such as Skilled Nursing 
Facilities, Outpatient Hospitals, Physicians, Hospice providers, and 
Durable Medical Equipment suppliers. Recovery Auditors have almost 700 
different review topics available for their review.

    Question. What is the timeline CMS expects to adhere to in terms of 
finalizing the procurement for the next round of Recovery Audit 
contracts?

    Answer. CMS is actively engaged in the procurement process for the 
next round of Recovery Auditor contracts and expects to award the new 
contracts this summer.
                            risk adjustment
    Question. The former CMS actuary, Rick Foster, recently wrote a 
paper indicating that the risk adjustment mechanism in the exchanges 
disincentivizes the enrollment of young and healthy individuals. That 
doesn't seem to bode well for the program. What are you doing to 
address this? We also hear regularly that the Medicare Advantage risk 
adjustment system does not adequately recognize certain conditions 
prevalent in the Medicare population. Shouldn't there be a close 
assessment of these risk adjustment programs to ensure they are well 
supported by medical evidence and promote coordinated care?

    Answer. The risk adjustment program is important to protect against 
potential effects of adverse selection inside the Marketplaces. It 
protects consumers' access to a range of robust coverage options by 
reducing the incentive for insurance companies to seek to insure only 
healthy individuals. This year, 3 million people ages 18 to 34 were 
signed up for coverage nationwide. The overall percentage of plan 
selections for those ages remains stable.

    As the Marketplace continues to mature, we are working to further 
refine the risk adjustment model. For example, in the 2017 Notice of 
Benefit and Payment Parameters Proposed Rule, published in December 
2015, we sought comment on a proposal to recalibrate the risk 
adjustment model to incorporate preventive services into the simulation 
of plan liability for the 2017 benefit year. We expect that the 
incorporation of preventive services will increase the risk scores of 
plans with healthier enrollees and more accurately compensate risk 
adjustment covered plans with enrollees who use preventive services. We 
have also taken a number of steps to strengthen the risk adjustment 
program more broadly speaking.

    CMS decides whether to include a condition category in the model 
after balancing several considerations, including each category's 
ability to predict costs for Medicare Parts A and B benefits, whether 
the diagnostic classifications measure disease burden, and whether 
diagnosis codes that are subject to discretionary or inappropriate 
coding should be excluded. Although not all conditions are included in 
the CMS-HCC model, the model still predicts beneficiaries' expected 
costs for all A and B benefits, including costs associated with chronic 
and mental health conditions. Given the goal of managed care 
organizations, we expect plans will appropriately manage chronic 
conditions and mental health conditions for their beneficiaries, 
irrespective of model refinements.

    We also take very seriously the concerns raised by stakeholders 
that the Medicare Advantage risk adjustment model may 
disproportionately affect specific populations, particularly dual 
eligible beneficiaries. In response to feedback about the accuracy of 
the Medicare Advantage CMS-HCC risk adjustment model for predicting 
costs of dual eligible beneficiaries, in 2015 CMS undertook an 
evaluation to assess how well the model performs for these 
beneficiaries. In October 2015 CMS invited public comment on Proposed 
Changes to the CMS-HCC Risk Adjustment Model for Payment Year 2017.
                       special enrollment periods
    Question. CMS has taken action to reduce the number of qualifying 
events that allow an individual to use a Special Enrollment Period for 
coverage, but there are still nearly 30 qualifying events while 
Medicare only has five. Does CMS plan to take further steps to reduce 
the number of qualifying events that allow for a Special Enrollment 
Period?

    Answer. Special enrollment periods (SEPs) are one way to make sure 
that people who lose health insurance during the year or who experience 
major life changes like getting married have the opportunity to enroll 
in coverage outside of the annual Open Enrollment period. SEPs are a 
longstanding feature of employer insurance. We are committed to making 
sure that SEPs are available to those who qualify for them, while also 
putting in place measures to protect SEP program integrity.

    We continue to review the rules around SEPs in order to keep them 
fair for issuers and for consumers. On January 19 CMS announced several 
changes \1\ including:
---------------------------------------------------------------------------
    \1\ https://www.regtap.info/uploads/library/
ENR_RetiredSEPs_011916_v1_5CR_011916.pdf.

          Clarifying the definitions of SEPs to ensure the rules are 
        clear to everyone,
          Reviewing all SEPs and eliminating those that are no longer 
        necessary, such as:
              Consumers who enrolled with too much in advance 
        payments of the premium tax credit because of a redundant or 
        duplicate policy;
              Consumers who were affected by an error in the 
        treatment of Social Security Income for tax dependents;
              Lawfully present non-citizens that were affected by 
        a system error in determination of their advance payments of 
        the premium tax credit;
              Lawfully present non-citizens with incomes below 
        100% FPL who experienced certain processing delays;
              Consumers who were eligible for or enrolled in COBRA 
        and not sufficiently informed about their coverage options;
              Consumers who were previously enrolled in the Pre-
        Existing Condition Health Insurance Program; and
          Providing stronger enforcement so that SEPs serve their 
        intended purpose and do not create unintended loopholes.

    We will continue to monitor how special enrollment periods are used 
and we anticipate that we may make changes in the future.
                              chronic care
    Question. Secretary Burwell, as you know, CMS has taken steps to 
improve care and outcomes for Medicare beneficiaries with multiple 
complex chronic conditions. Alzheimer's disease is a progressive, fatal 
condition affecting an estimated 5.1 million American seniors. Medicare 
beneficiaries with Alzheimer's and other dementias pose a unique 
challenge in terms of utilization and spending to the Medicare program. 
Seventy-four percent of seniors with Alzheimer's disease have at least 
one additional chronic condition such as hypertension, heart disease 
and diabetes. High rates of co-morbidity among seniors with Alzheimer's 
and other dementias are helping to drive the rapidly rising cost of 
care for this population. Alzheimer's disease complicates the ability 
for individuals and families to manage these other chronic conditions, 
resulting in 3 times as many hospitalizations and higher rates of 
Medicare spending than beneficiaries who do not have dementia. 
Additionally, estimates show that about 1-in-5 Medicare dollars will be 
spent on someone with Alzheimer's disease or other dementia in 2015, a 
total Medicare spend of about $113 billion. Absent the development of 
an effective treatment or cure, this number is expected to grow to 
around $589 billion by 2050 (not adjusted for inflation), representing 
a significant threat to the Medicare program. Until a cure is found, we 
must work together to improve care for Medicare beneficiaries and their 
families facing this devastating disease.

    Responding to the growing threat that Alzheimer's and other 
dementias poses to Medicare spending, the Senate Finance Committee's 
Bipartisan Working Group on Chronic Care recognizes that more time is 
needed by clinicians to discuss the diagnosis of serious or life-
threatening illnesses, like Alzheimer's disease, with their patients. 
As a result, the Working Group has proposed a one-time visit code in 
Medicare for beneficiaries who have received a diagnosis of Alzheimer's 
or another dementia to allow for a discussion about the disease and its 
progression, existing treatment options, and the availability of other 
resources that would reduce risks to the beneficiary and promote 
disease self-management. In light of this proposal, as well as the 
National Plan to Address Alzheimer's Disease's Goal 2: Enhance Care 
Quality and Efficiency, can you help us to identify and address gaps in 
care planning for those beneficiaries with Alzheimer's disease and 
other dementias to ensure they (and their families and caregivers) are 
receiving appropriate and comprehensive care planning services 
following a diagnosis?

    Answer. HHS has made extensive investments to address the 
challenges of Alzheimer's disease and related dementias (ADRD). The 
President's FY17 Budget proposes a total funding level of $4.7 billion 
for these diseases, including an increase of $275.5 million over FY16 
enacted levels, the majority of which is Medicare spending. The Budget 
continues the Department's commitment to support effective research, 
education, and outreach, as well as patient, family and caregiver 
services.

    I would like to thank you and your colleagues for your leadership 
on this issue and continued support of the National Alzheimer's Project 
Act (NAPA). NAPA offers an important opportunity to build on and 
leverage HHS programs and other Federal efforts to help change the 
trajectory of ADRD. In coordination with other Federal partners, HHS is 
working to carry out NAPA's charges to address gaps and improve 
coordination between HHS agencies on issues such as research and 
services, acceleration and development of ADRD treatments, improvement 
in early diagnosis and coordination of care, including care planning, 
reduction of ethnic and racial disparities in rates of ADRD, and 
coordination with international partners.

    Although finding a cure for ADRD is an important part of our NAPA 
work, over the past year the discussion at NAPA Advisory Council 
(Council) meetings has gradually evolved from a sole focus on 
increasing the research budget toward the topics of care and services 
for individuals who have dementia and support for their family 
caregivers. Among the Council's new initiatives is planning a Care and 
Support for Dementia Summit, which is intended to provide an overview 
of care and services issues, existing care models, and the future of 
care.

    The expansion in the Council's focus is consistent with HHS 
agencies' progress in improving services for people with dementia and 
their caregivers. Work includes programs by HRSA to educate physicians 
and providers about how to talk to families about dementia diagnoses 
and long-term care options. The Administration for Community Living has 
funded dementia-capable and evidence-based service systems for people 
in the community with dementia and their family caregivers, including 
improving the Aging Network, which provides caregivers with resource 
materials and support programs. Additionally, NIH has ramped up funding 
for research--its investments grew 25% between FY11 and FY14.

    Through a Chronic Care Management Services code, effective on 
January 1, 2015, Medicare will pay separately under the Medicare 
Physician Fee Schedule for non-face-to-face care coordination services 
furnished to Medicare beneficiaries with multiple chronic conditions by 
qualifying practices. This provides payment for at least 20 minutes of 
clinical staff time provided during a month for patients with the 
following requirements: multiple chronic conditions expected to last at 
least 12 months, or until the death of the patient; and chronic 
conditions which place the patient at significant risk of death and/or 
decline. It requires the establishment, implementation, revision, or 
monitoring of a comprehensive care plan. Alzheimer's disease and 
related dementias are among the chronic conditions listed that would 
fall under the Chronic Care Management Services.
                             failed co-ops
    Question. What steps is CMS taking to ensure stakeholders are made 
whole and consumers held harmless from incurred costs of failed CO-OPs? 
How many total consumers are impacted through the failed CO-OPs? What 
percentage of the total exchange enrollment has been impacted through 
the closures? What is the impact of the CO-OP closures on the wider 
market including insurers, providers, and agents/brokers?

    Answer. The primary focus of all our efforts is to ensure that CO-
OPs are meeting the needs of their consumers. CMS continues to help CO-
OPs identify and correct issues and improve their insurance plans.

    Each of the consumers in the CO-OPs that closed at the end of 2015 
maintained coverage until the end of the year, and nearly three-
quarters \2\ of the CO-OP Marketplace consumers have continued their 
coverage in a new plan in 2016. Affected CO-OP enrollees had access to 
a special enrollment period, and are able to shop for 2016 coverage on 
the Marketplace until February 28, 2016. In all cases, CMS is focused 
on making sure consumers continue to receive medical services.
---------------------------------------------------------------------------
    \2\ Does not include consumers who enrolled in new plans outside 
the Marketplace.

    The CO-OP program is only one part of the Affordable Care Act's 
overall approach to encourage competition and to give consumers a 
variety of affordable coverage choices. Whether consumers are getting 
coverage from a CO-OP, another issuer, or Medicaid, millions of 
Americans who were previously uninsured now have access to affordable, 
high quality health care coverage. As several of the Affordable Care 
Act's coverage provisions took effect, an estimated 17.6 million 
Americans gained coverage through the third quarter of 2015. In the 
years since the passage of the Affordable Care Act, we have seen 
increased competition among health plans and more choices for 
consumers.\3\ During the third Marketplace Open Enrollment, 9 out of 10 
returning customers were able to choose from 3 or more issuers for 2016 
coverage, up from 7 in 10 in 2014.\4\
---------------------------------------------------------------------------
    \3\ www.hhs.gov/about/news/2015/07/30/competition-and-choice-in-
the-health-insurance-marketplace-lowered-premiums-in-2015.html.
    \4\ www.hhs.gov/about/news/2015/07/30/competition-and-choice-in-
the-health-insurance-marketplace-lowered-premiums-in-2015.html.

    Question. What steps will CMS take to recoup losses from CO-OPs 
that appear unlikely to repay their loans? Who will be responsible for 
loan repayment once a CO-OP ceases operations? How much money has been 
---------------------------------------------------------------------------
lost?

    Answer. We take our obligation to taxpayers very seriously. The 
U.S. Department of Justice is responsible for collecting any debts owed 
the U.S. Government. While it is too early to tell how much money can 
be recovered, we are working in close collaboration with the Department 
of Justice and will use all available tools to recover money from these 
companies.

    The 12 CO-OPs currently winding down received $1.24 billion in 
total loan funding; $1.05 billion of that was awarded before coverage 
began on January 1, 2014.

    Question. In the NBPP for 2017 CMS repeats their proposal for 
individuals to opt for automatic reenrollment into a different issuer 
if the costs are lower. What steps would CMS take to ensure individuals 
are not auto reenrolled into a CO-OP that is no longer selling due to 
enrollment caps or closure?

    Answer. All Marketplace plans available to consumers for plan year 
2016 were certified for sale on the Marketplace prior to the start of 
Open Enrollment on November 1, 2015. As you may recall, announcements 
that CO-OPs were winding down were also made before the start of Open 
Enrollment, so those CO-OP plans were never certified, and were not 
available, for sale on HealthCare.gov for 2016. Because the auto re-
enrollment process takes place after the start of Open Enrollment, 
consumers could not be auto re-enrolled into a closed CO-OP. State 
Departments of Insurance, as the primary regulators of insurance, may 
authorize a freeze on new enrollment for any issuer, including CO-OPs, 
however, such a freeze does not impact members continuing with the 
plan. Consumers enrolled in a CO-OP who did not make an active plan 
selection for 2016 were auto re-enrolled into their plan for the 2016 
plan year.

    Question. How many CO-OPs are participating in the OPM Multi-State 
Plan Program and how many States do they cover?

    Answer. The CO-OP operating in Connecticut, HealthyCT, is the only 
CO-OP participating in the OPM Multi-State Plan Program for the 2016 
coverage year.
                            existing co-ops
    Question. What is CMS doing to make sure CO-OPs are priced 
adequately? Is CMS reviewing how many months of operating capital the 
remaining CO-OPs have available to determine if they will remain 
solvent for the entire calendar year of 2016? Does CMS expect any CO-
OPs to close in 2016 during the benefit year? Since closing CO-OPs 
during the benefit year is disruptive to consumers because they will 
need to select new coverage, possibly restart their deductible or find 
a new doctor, what oversight metrics is CMS using and how is CMS 
coordinating with States ensure no other CO-OPs will close during the 
benefit year? What are DOIs doing to address issues before problems 
occur? How do HHS and the DOI validate financial stability?

    Answer. CMS has obligations to operate as a proper steward of the 
taxpayer dollars issued through the loan program and to administer the 
CO-OP Program for the benefit of consumers. Since awarding both start-
up and solvency loans, CMS has been closely monitoring and evaluating 
the CO-OPs to assess performance and compliance, and has engaged 
regularly with State Departments of Insurance (DOIs), which are the 
primary regulators of insurance issuers in the States. As the primary 
regulators of insurance, States retain responsibility for regulating 
CO-OPs, analyzing and actuarially certifying rates and surplus levels.

    CMS uses a stringent oversight process. All CO-OPs are subject to 
standardized, ongoing reporting to CMS and interactions with CMS that 
include weekly, biweekly, or monthly calls to monitor goals and 
challenges; periodic on-site visits; performance and financial 
auditing; and monthly, quarterly, semi-annual, and annual reporting 
obligations. During site visits, CMS reviews management structure and 
staffing, financial status, business strategy, the policies and 
procedures of the CO-OP, marketing and sales information, and 
operations, including vendor management and oversight. CMS also reviews 
whether a CO-OP is meeting their obligations for medical management and 
member relations. CMS also collaborates with State Departments of 
Insurance (DOIs) concerning each CO-OP loan recipient.

    CMS also monitors the CO-OPs' overall financial condition using 
several factors of the Federal Deposit Insurance Corporation's Uniform 
Financial Institutions Rating System. CO-OPs have monthly, semi-annual, 
and annual reporting requirements, including financial statements, 
balance sheets, income statements, statements of cash flow, and 
enrollment statistics. Last year, CMS increased the data and financial 
reporting requirements for CO-OPs. Each CO-OP is required to provide a 
semi-annual statement of its compliance with all relevant State 
licensure requirements, and, if necessary, an explanation of any 
deficiencies, warnings, additional oversight, or any other adverse 
action or determination by DOIs received by the CO-OP. If the CO-OP is 
experiencing compliance issues with State regulators, the CO-OP is 
required to describe the steps being taken to resolve those issues. CMS 
meets monthly with the State insurance regulators regarding each CO-OP. 
This additional financial data has helped CMS to identify 
underperforming CO-OPs, providing CMS the opportunity to work with the 
CO-OPs and DOIs to help correct issues.

    Finally, CMS can terminate its loan agreement with a CO-OP if it 
determines that the CO-OP is no longer viable, sustainable, or serving 
the interests of the community. CMS works closely with DOIs and shares 
information to assist in their assessments of CO-OPs. If a loan 
agreement is terminated, CMS works with the State DOI and the CO-OP 
board to wind down operations in an orderly way to mitigate impact to 
the consumer.

    While CO-OPs are primarily responsible for their own success, CMS 
will continue to help them identify and correct issues and make 
improvements. CMS is committed to continuing its work with the CO-OPs 
offering coverage this year to facilitate progress and expand into new 
markets when appropriate. CMS has also clarified our policies on 
important topics \5\ and is exploring what changes could be made to 
help CO-OPs diversify their boards and grow and raise capital, while 
still preserving the fundamentally member-run nature of the CO-OP 
program.
---------------------------------------------------------------------------
    \5\ https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/
Downloads/CO-OP-Questions-Final-1-27-16.pdf.

    Question. How much funding remains within CMS that has been 
allocated but not drawn down by CO-OPs? What happens to funds that are 
---------------------------------------------------------------------------
returned to CMS?

    Answer. As of December 31, 2015 $2.378 billion had been disbursed 
of a total $2.459 billion. Any funds paid back by the CO-OPs or 
recouped by the Department of Justice are returned to the Treasury.
                   health reimbursement arrangements
    Question. Historically, many small business owners reimburse 
employees for medical care and services through Health Reimbursement 
Arrangements (HRAs). However, due to a Department of Treasury 
regulation, since July 1, 2015, these businesses, which are voluntarily 
providing financial assistance to help employees pay for health care 
through an HRA, are now subject to a $100 per day, per employee fine--
totaling $36,500 per employee annually, up to $500,000 total. This is 
18 times more than the $2,000 employer mandate penalty for not 
providing any coverage. These small businesses are trying to help their 
workers--but the Internal Revenue Service says they should be fined for 
doing so.

    The Small Business Healthcare Relief Act (S. 1697) is a bipartisan, 
common-sense bill before my committee that would allow small businesses 
with less than 50 employees to continue to provide employees with an 
HRA without being subject to outrageous IRS fines. Small businesses 
should be allowed to do the right thing: Help employees pay for health 
insurance and medical expenses without being subject to excessive 
financial punishment.

    I don't understand how this administration can claim they want to 
make health care more accessible and affordable and yet impose a 
$36,500 per employee penalty on an employer that wants to help their 
employees afford coverage. While I will continue to work with my 
colleagues to advance this legislation, you could make legislation 
unnecessary by rescinding this outrageous IRS ruling.

          Why is the IRS punishing employers who are simply trying to 
        offer assistance to their employees?
          What kind of impact do you think the IRS ruling on HRAs is 
        having on employers and employees?
            1.  Are employers dropping HSAs as a benefit?
            2.  What types of cost increases are employees seeing as a 
        result of the ruling?

    Answer. We are willing to work with Congress on any proposal that 
improves access, affordability, quality, and health of the economy. 
Because this proposal could have substantial revenue effects, it does 
not meet this test without including an offset. I would defer you to my 
colleagues at the Department of Treasury for specifics around their 
regulations.
                    employer reporting requirements
    Question. The ACA reporting requirements compel employers to report 
significant amounts of data detailing information about employees, 
their health plans and who had access to employer sponsored insurance 
to the IRS after the end of each year. This information will be used to 
levy the individual mandate penalties. It will also be used to levy 
penalties on low incomeworkers who were erroneously granted an advanced 
premium tax credit by the Exchanges when the employee had an existing 
offer of employer sponsored insurance.

    Unfortunately, because employers are reporting information on the 
availability of employer sponsored insurance up to 17 months after the 
exchange granted the erroneous advanced premium tax credit, these lower 
income employees could be left with a shocking tax bill over a year and 
a half later.

    When will the IRS notify individuals of their potential tax 
liability and wouldn't it help low income individuals and improve tax 
administration if the administration used up-to-date information about 
the availability of employer sponsored insurance at the time 
individuals were applying for tax credits rather than 17 months later?

    Answer. As you know, applicable large employers (ALEs) must report 
to the IRS information about the health care coverage, if any, they 
offered to full-time employees. ALEs are also required to furnish a 
statement to each full-time employee that includes the same information 
provided to the IRS. The IRS will use this information to administer 
the employer shared responsibility provisions and the premium tax 
credit, and individuals who purchased health insurance coverage through 
the Marketplace may use this information to verify their eligibility 
for employer-
sponsored coverage. Like other information reporting, this information 
is provided after the conclusion of the year, reflecting that coverage 
and other related information may change over the course of the year.

    Advance payments of the premium tax credit (APTC) are payments 
during the year to an individual's insurance provider that pays for 
part or all of the premiums for a qualified health plan covering the 
individual and his or her family. APTC eligibility is based on the 
Marketplace's estimate of the premium tax credit the individual will be 
able to take on his or her tax return. If APTC is paid for an 
individual or a member of his or her family, the individual must 
reconcile (or compare) the APTC with the premium tax credit at the time 
that the individual files his or her tax return. If the APTC is more 
than the premium tax credit, the individual must repay the excess APTC, 
which occurs as part of the individual's tax filing process. However, 
the amount that an individual is required to repay may be limited based 
on the individual's household income and filing status. Individuals 
calculate the amounts they are owed or owe a result of reconciliation 
themselves on their tax returns.

    Several tools are used to help determine whether an individual 
enrolling in Marketplace coverage is eligible for employer-sponsored 
coverage. First, CMS has provided an employer coverage tool to enable 
consumers to get information about employer coverage to which they have 
access, available at:
https://www.healthcare.gov/downloads/employer-coverage-tool.pdf.

    In addition, starting in 2016, the FFM will notify certain 
employers whose employees enrolled in Marketplace coverage with APTC 
because the employee attested that he or she was neither enrolled in 
employer sponsored coverage nor eligible for employer coverage that is 
affordable and meets the minimum value standard. The FFM will send 
notices to employers if the employee received APTC for at least one 
month in 2016 and if the FFM has a complete address for the employer. 
Employers receiving this notice may appeal the Marketplace's 
eligibility determination.

    We will continue to work with consumers so that they understand the 
eligibility requirements for coverage and financial assistance. I would 
refer you to my colleagues in the Department of Treasury for further 
specifics around the premium tax credit reconciliation process and the 
employer reporting requirements.
                  aca social security number reporting
    Question. The ACA reporting requirements require employers to 
report dozens of new data elements to the IRS, including private 
information such as dependent and spouse social security numbers.

    In an era where even the Federal Government's most private personal 
data has been breached, how can you ensure employers and Americans that 
their private information will be safe guarded?

    Answer. At HHS, we vigilantly monitor, test, and strengthen our 
systems against cyberattacks, in order to prevent, detect and respond 
to any potential vulnerabilities. We are continually updating physical 
and cybersecurity controls for our systems, including High Value 
Assets, defined as systems, facilities, data and datasets deemed of 
particular interest to potential adversaries, at all of our Divisions. 
HHS has in place teams that constantly work to identify potential 
issues and risks, share best practices and lessons learned, and focus 
on cybersecurity policy and monitoring, training and awareness.

HHS Computer Security Incident Response Center (CSIRC) scans against 
new indicators of compromise--the unique fingerprints of an incident--
immediately upon receipt and notifies all operating divisions within 24 
hours. HHS has multiple layers of cybersecurity, including:

          Required use of a hardware-based Personal Identity 
        Verification (PIV) cards or alternative forms of strong 
        authentication; this requirement is one of the most significant 
        steps that can be taken to reduce the risk of adversaries 
        penetrating networks and systems.
          Continuing to work on ensuring employees use strong 
        authentication to access HHS networks and have access to only 
        those resources that are required for their job function.
          Through the Trusted Internet Connection (TIC) initiative, 
        HHS reduced its number of Internet connections from 
        approximately 150 to 3. This allows us to better deploy cutting 
        edge tools to detect and block Internet-based attacks while 
        minimizing the potential network entrance points that could be 
        exploited.

    HHS also continues to enhance training and awareness activities to 
better educate HHS employees on threats such as phishing.

    In addition, the HHS Office for Civil Rights (OCR) administers and 
enforces the HIPAA Privacy, Security, and Breach Notification Rules, 
which require covered health care entities (health plans, health care 
clearinghouses, and most health care providers) and their business 
associates to protect the privacy and security of individuals' health 
information and establish individual rights with respect to that 
information. Covered entities--including components of certain Federal 
entities that are health care providers and/or health plans--and 
business associates must implement reasonable and appropriate 
administrative, physical, and technical safeguards to protect the 
information they maintain from unauthorized uses and disclosures. In 
the case of a breach, covered entities are obligated to notify affected 
individuals, HHS, and in certain cases the media, of the breach. 
Importantly, entities can avoid breaches and the attendant breach 
notification requirements by implementing appropriate protections.

    OCR opens investigations based on individual complaints and certain 
breach reports as well as information about potential noncompliance 
obtained by other means, such as through media reports. All HIPAA 
covered entities and their business associates, including those that 
may be Federal entities, could be subject to civil money penalties for 
noncompliance with the HIPAA Rules. Moreover, OCR refers complaints and 
breach reports that implicate the criminal provisions of HIPAA to the 
Department of Justice (DOJ), as DOJ has criminal jurisdiction under 
HIPAA. DOJ determines whether or not to pursue any potential criminal 
violations of HIPAA.

    I defer to IRS and Treasury for more information about their 
systems.
                         aca tax credit notices
    Question. Obamacare requires HHS to send a notice to an employer 
when an employee is deemed eligible for an advanced premium tax credit. 
These notices are important because they allow employers to warn 
employees that they may be subject to a surprising tax bill when the 
employer has already offered the employee health coverage.

    Would a more up-to-date and substantiated data base help decrease 
the number of erroneous advanced premium tax credit determinations?

    Employers expected to receive notices beginning in 2015. What date 
will you begin sending employers notices so they can help their low 
income workers avoid unexpected tax penalties?

    Answer. HHS has previously discussed the challenges in building a 
new database for checking employer sponsored coverage information--
while we do support reducing reporting burden by consolidating and 
streamlining reporting, if feasible, building the functionality 
required to collect and retain information regarding employer-sponsored 
insurance coverage will be time and resource-intensive. Starting in 
2016, the FFM will notify certain employers whose employees enrolled in 
Marketplace coverage with APTC because the employee attested that he or 
she was neither enrolled in employer sponsored coverage nor eligible 
for employer coverage that is affordable and meets the minimum value 
standard. The FFM will send notices to employers if the employee 
received APTC for at least one month in 2016 and if the FFM has a 
complete address for the employer. The IRS will independently determine 
any liability for the employer shared responsibility payment without 
regard to whether the Marketplace issued a notice. We will continue to 
work with consumers so that they understand the eligibility 
requirements for coverage and financial assistance. I would refer you 
to my colleagues in the Department of Treasury for more specifics 
around the employer reporting requirements.
                               pace plans
    Question. The Program of All-Inclusive Care for the Elderly (or 
PACE) has a proven track record of providing the highest quality of 
care to some of our most vulnerable seniors--those who need a nursing 
home level of care but wish to continue living in the community. In 
Medicare, Medicaid and the private sector, health care delivery and 
payment systems are seeing significant and accelerating change. Yet the 
PACE, which pioneered so many of the features we now seek to build into 
our health care system, is being constrained by regulations that are 
almost a decade old.

    What is the administration doing to update those regulations and 
provide more flexibility to PACE so that our seniors can have greater 
access to its gold-standard, proven and replicable model of integrated, 
community-based and person-centered care?

    Answer. I share your support for the PACE program, and CMS is 
taking steps to modernize and streamline PACE enrollment and services.

    PACE has proven successful in keeping frail elderly individuals in 
the community, and we agree that we should revise certain regulatory 
provisions to afford more flexibility as a means to encourage the 
expansion of the PACE program to more States, increase access for 
participants, and further enhance the program's effectiveness at 
providing care while reducing costs. CMS is proposing to revise and 
update policies to reflect subsequent changes in the practice of caring 
for PACE participants and changes in technology based on our experience 
implementing and overseeing the PACE program. CMS has received numerous 
suggestions from PACE organizations, beneficiaries, members of 
Congress, and other stakeholders and looks forward to continuing to 
work with all stakeholders throughout the rulemaking process.

    CMS is dedicated to continuing to explore new opportunities and 
ideas to further strengthen PACE programs and services.

    Question. Recently, Congress gave the Department authority to 
develop pilots for extending the PACE model to new populations. How is 
the administration proceeding in the development of those pilots and 
when can we expect CMS to announce the opportunity to participate in a 
pilot?

    Answer. The PACE Innovation Act of 2015 expands the Department's 
authority to allow waivers in order to conduct demonstration projects 
that involve PACE. We are excited about these new opportunities, and 
CMS is developing options for moving forward.

    The 2016 President's Budget includes a legislative proposal to 
create a pilot demonstration to test whether the PACE program can 
effectively serve a younger (55 and under) population without 
increasing costs. This proposal was removed from the 2017 President's 
Budget because the recently passed PACE Innovation Act grants HHS the 
authority to test this expansion and other PACE models under the CMS 
Innovation Center authority.

    CMS is actively working with stakeholder and advocacy groups to 
determine how the PACE comprehensive care approach can be expanded to 
reach a broader population. We will keep your staff apprised of the 
status of the pilot.

    Question. Currently Medicare beneficiaries who enroll in the 
Program of All-
Inclusive Care for the Elderly (or PACE) do not have the option to keep 
the Part D plan of their choice. For many, this is a disincentive to 
enroll in PACE. What steps would CMS require to allow Medicare 
beneficiaries to have a choice in the Part D plan they enroll in if 
they choose to enroll in PACE?

    Answer. Beneficiaries who join a PACE program get Part D-covered 
drugs and all other necessary medication from the PACE program. 
Similarly, in most cases, beneficiaries who choose to join a Medicare 
Advantage Plan that includes prescription drug coverage must take the 
drug coverage that comes with the Medicare health plan if it's offered. 
While we believe coordination between medical and drug benefits under 
the current system is beneficial, we would be happy to provide 
technical assistance on any proposals you may have in this area.
             world health organization milk marketing rules
    Question. I have become aware of a measure moving through the World 
Health Organization that seeks to prohibit the marketing of any milk 
consumed by young children. My understanding is this was developed with 
little or no public input. This measure carries significant public 
health, trade and economic implications for the U.S. dairy industry 
that need to be further examined.

    Will you commit to working with this committee and all impacted 
stakeholders to halt this process until these implications are fully 
understood?

    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,\6\ and presented it 
to the WHO Executive Board (EB) 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.
---------------------------------------------------------------------------
    \6\ As presented in report EB138/8: Maternal, infant and young 
child nutrition. Available at http://apps.who.int/gb/ebwha/pdf_files/
EB138/B138_8-en.pdf (accessed March 14, 2016).

    WHO developed the draft guidance using a Scientific and Technical 
Advisory Group (STAG) process. The STAG was convened in 2013 and 
produced several reports, including a draft of the guidance that was 
presented to WHO in 2015. WHO held online and in-person public 
consultations in August 2015, revised the guidance, and presented it to 
Member States for the WHO Executive Board (EB) meeting in January 2016. 
During the EB meeting, WHO agreed to hold an additional consultation 
from February 1-29, 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, not to limit product availability. The draft does not seek to 
prohibit the marketing of all milk products consumed by young children, 
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.

    HHS is working with other relevant Federal agencies to prepare a 
technical comment submission to WHO, and has had multiple conversations 
with stakeholders on the matter. HHS will continue to work with the 
other agencies and discuss remaining concerns with stakeholders.
      physician-focused payment model technical advisory committee
    Question. The bipartisan Medicare Access and CHIP Reauthorization 
Act of 2015 established the ``Physician-Focused Payment Model Technical 
Advisory Committee'' to consider alternative payment models proposed by 
stakeholders. The Technical Advisory Committee is to evaluate the 
proposed models against criteria established by the Secretary through 
notice and comment rulemaking. The Technical Advisory Committee is to 
then make comments and recommendations to the Secretary as to the 
extent the proposed models meet the criteria. The Secretary is required 
to provide a detailed response to those recommendations that is made 
public on the CMS website. While nothing in the statute requires the 
Secretary to implement alternative payment models recommended by this 
Technical Advisory Committee, the committee is meant to expand the 
Secretary's ability to evaluate models. Some stakeholders are 
interpreting comments by CMS officials pointing out that the statute 
does not require the agency to implement Technical Advisory Committee 
recommended-models as a lack of interest in the committee's 
deliberations. How do you envision that HHS and CMS will use the 
Technical Advisory Committee to maximize its utility?

    Answer. CMS looks forward to receiving recommendations for new 
physician-
focused payment models from the Physician-Focused Payment Model 
Technical Advisory Committee (the PTAC). We will need robust 
stakeholder engagement with the PTAC, including physicians and other 
clinicians, to suggest well designed, robust alternative payment 
models, including eligible alternative payment models under MACRA. 
Although the statute does not require CMS to test models that are 
recommended by the PTAC, CMS will give serious consideration to 
proposed physician-focused payment models recommended by the PTAC. The 
PTAC serves an important advisory role in the implementation of 
alternative payment models.

    In addition, section 1115A of the Social Security Act authorizes 
the Center for Medicare and Medicaid Innovation (Innovation Center) to 
test innovative payment and service delivery models to reduce program 
expenditures while preserving or enhancing the quality of care. Under 
this authority, the Innovation Center is able to pursue new physician-
focused payment models, including ones that could incorporate the 
recommendations of the PTAC. We believe such models hold great promise 
for achieving better care, smarter spending, and healthier people.
                      continuous glucose monitors
    Question. In your comments regarding the administration's budget, 
you mentioned that the department is working to give Americans the 
tools to lead healthy and productive lives. While that is a laudable 
goal, I point out that there are tools on the market right now that 
would help Americans greatly but yet are inaccessible due to Medicare's 
lack of coverage. I am speaking in particular about continuous glucose 
monitors. Approved by FDA more than 10 years ago, these devices are 
covered by more than 95% of all private plans yet Medicare still does 
not cover them for beneficiaries with insulin-dependent diabetes. I ask 
that you work with CMS to find a way to resolve this issue so that our 
seniors, who stand to benefit the most from this important technology, 
have access and can continue to lead healthy and productive lives.

    Answer. Thank you for raising this question. Providing Americans 
the tools to live healthy lives is a shared goal of ours. However, for 
items and services to be covered by Medicare, the law requires that 
they must be eligible for coverage under a defined benefit category, be 
reasonable and necessary for the diagnosis or treatment of an injury or 
illness, and meet all applicable statutory and regulatory requirements. 
The Medicare statute provides coverage for broad categories of 
benefits, including durable medical equipment (DME). For a device to 
qualify as DME, it must, among other requirements, be primarily and 
customarily used to serve a medical purpose. ``Precautionary'' 
equipment, however, has long been considered nonmedical in nature, and 
therefore is not covered as DME. Consistent with current guidance, 
including from the FDA and continuous glucose monitor (CGM) 
manufacturers, CGMs are not intended to replace a patient or 
beneficiary's traditional blood glucose monitoring via fingerstick, 
test strip, and glucometer. Consequently, the functionality of a CGM--
at least at this time in the device's development--is precautionary. A 
CGM is used to indicate when a fingerstick and glucose meter reading 
may be necessary, so that a beneficiary can, after getting an accurate 
reading, make a therapeutic decision; while the CGM supplements that 
process, it does not replace it.

                              puerto rico
    Question. Secretary Burwell, the President's budget calls for 
roughly $30 billion in additional Medicaid funding for Puerto Rico. 
You, along with Secretary Lew and NEC Director Zients, sent a letter 
last year to Congress with a somewhat presumptuous reminder to us about 
our responsibilities, and identified that additional health funding 
should be provided in a ``fiscally responsible manner.'' I have two 
questions about the funding called for in the President's budget.

    First, given that I have been asking the administration how much 
Medicare funding you'd like for Puerto Rico and how you'd propose to 
pay for it, why have you not provided a direct and complete answer to 
date?

    Answer. HHS is committed to continuing our work to strengthen 
Puerto Rico's health care system and improve health outcomes on the 
island using available administrative authorities. With regard to the 
Medicare program specifically, HHS has explored several changes to 
expand resources for health care providers and ensure beneficiary 
access to care on the island.

          Provide a More Robust Accounting for Low Income Patients and 
        Uncompensated Care--The FY17 Budget proposes to give the 
        Secretary authority to adjust Medicare's disproportionate share 
        (DSH) payments to better account for the higher costs of low 
        income patients in Puerto Rico. Both DSH and uncompensated care 
        payments depend, in part, on patients being eligible for 
        Supplemental Security Income (SSI) which Puerto Ricans do not 
        receive. As indicated in the FY 2016 Inpatient Prospective 
        Payment System (IPPS) final rule, HHS expects to further 
        address the distribution of uncompensated care payments to 
        Puerto Rico in the 2017 rulemaking process.
          Increasing Payment Rates for Hospitals in Puerto Rico--HHS 
        is moving forward with accelerated implementation of new 
        legislation passed by Congress at the end of last year that 
        aligns the formula to pay hospitals in Puerto Rico with the 
        formula used in the 50 States, increasing hospital payment 
        rates in the Commonwealth by approximately 5 percent.

    More detail on additional administrative actions will be made 
available as part of ongoing rulemaking activity.

    That said, the single most impactful step we can take is reforming 
Puerto Rico's Medicaid program. As part of the President's FY17 Budget, 
the administration detailed its proposal to improve health care 
outcomes in Puerto Rico and prevent hundreds of thousands of Americans 
from losing access to health care. The proposal would lift the Federal 
cap on Medicaid funding to Puerto Rico and other U.S. territories, 
raise the Federal Medicaid rate from 55 percent to 83 percent over time 
as territories strengthen and modernize their Medicaid programs, and 
expand eligibility to 100 percent of the Federal poverty level over 
time. These reforms are integral to the administration's broader 
roadmap to financial stability for Puerto Rico.

    A true solution for the 3.5 million Americans living in Puerto 
Rico, including reforms to strengthen Puerto Rico's Medicaid program, 
would require legislation. We are happy to work with you as you develop 
legislative proposals.

    Question. And, second, if you were to put the administration's $30 
billion of Medicaid funding increase in stand-alone legislation, please 
offer specific ways in which you propose to fund it in a ``fiscally 
responsible manner.''

    Answer. The President's budget includes a package of HHS 
legislative proposals that on net saves $242 billion over 10 years, and 
our initiative to strengthen Medicaid in the territories must be viewed 
in that context. Specifically, the budget proposal provides additional 
resources to territory Medicaid programs in a fiscally responsible 
manner by requiring improved financial management and program integrity 
capacity and full mandatory benefits to receive full Federal financial 
support. We believe that these reforms are integral to the 
administration's broader roadmap to financial stability for Puerto 
Rico.

    We are happy to work with you as you develop legislative proposals.
                        medicare part d program
    Question. An area of great concern on the topic of executive 
overreach is the Medicare Part D program.

    There have been rumblings that the President may issue an executive 
order that would allow the Federal Government to negotiate prescription 
drug prices in the Medicare Part D program. Such an executive order 
would be in violation of the law as the statute explicitly prohibits 
such interference in private negotiations.

    Despite this fact, I take the possibility of an executive order 
very seriously. I am a strong supporter of the biopharmaceutical 
industry as a source of innovation and intellectual property that 
produces life-saving drugs. The Part D program gets these needed drugs 
to Medicare beneficiaries. We need to keep the program as it was 
originally structured because it works. Beneficiaries have choice of 
prescription drug plans. Private entities negotiate to keep costs down. 
Overall spending is significantly less than originally projected. 
Beneficiary satisfaction is very high.

    Moreover, allowing the government to ``negotiate'' prices is not a 
new idea. Congress has considered this policy and chosen against it. 
The President's budget proposal States that it has no budgetary impact. 
The Congressional Budget Office doesn't see it as a big saver.

    So, having said all that, my question is: Secretary Burwell, is 
anyone at HHS working with, or has HHS worked with, the White House on 
an executive order that would allow the government to negotiate prices 
or on any other changes related to drug prices?

    Answer. To my knowledge, we are not working with the White House on 
an executive order that would allow the government to negotiate prices.

    Having said that, drug costs are not just the State and Federal 
governments' fastest growing cost, but are a real kitchen table issue 
for working families and retirees. Per capita Part D costs increased by 
11 percent in 2014, driven primarily by increased spending on high cost 
drugs in the catastrophic phase of the benefit, which grew much faster 
than any other part of the program.\7\ The extremely high cost of 
certain specialty drugs raises issues about whether beneficiaries have 
access to the drugs that they need most. The President's FY 2017 budget 
proposes one potential solution for this issue: allowing the Secretary 
to negotiate prices for high-cost drugs.
---------------------------------------------------------------------------
    \7\ https://blog.cms.gov/2015/11/20/remarks-of-cms-acting-
administrator-andy-slavitt-at-the-hhs-pharmaceutical-forum-innovation-
access-affordability-and-better-health/.

    Over the past several months, HHS has engaged with consumers, 
physicians, clinicians, employers, manufacturers, health insurance 
companies, representatives from State and Federal Government, and other 
stakeholders to discuss ideas on how the health care system can meet 
the dual imperatives of encouraging drug development and innovation, 
---------------------------------------------------------------------------
while ensuring access and affordability for patients.

    We welcome continued engagement and feedback as we work together to 
address this rapidly growing cost center, while continuing to support 
innovation and access.

                                 ______
                                 
               Questions Submitted by Hon. Chuck Grassley
    Question. Chairman Hatch and I wrote to CMS in June 2015 about an 
issue with Obamacare. The concern was in regards to the inaccuracy of 
advance premium tax credit (APTC) payments made to Qualified Health 
Plans (QHP).

    In December 2015, the Department of Health and Human Services (HHS) 
Office of Inspector General (OIG) found that CMS was making payments on 
behalf of people who may not have qualified to receive them.

    It appears that CMS is not obtaining payment data on an enrollee-
by-enrollee basis when making APTC payments. In addition, CMS is not 
providing APTC payment data to the IRS during the course of the year.

    The lack of controls in place at CMS and the lack of communication 
with the IRS to track payments made to individuals is concerning 
because billions of taxpayer dollars are at stake.

    When HHS OIG issued the December report, CMS was using an ``interim 
plan'' to manage the flow of information between the QHPs and CMS. CMS 
claimed that the interim plan would only be used until January 2016 
when CMS would require all issuers to use a new automated computerized 
system for payment based on 
enrollee-by-enrollee tracking. In addition, HHS OIG recommended that 
CMS share more APTC payment data with the IRS in order to allow IRS to 
``verify the data reported on each individual's Form 1095-A.''

    Do you know if CMS has launched the new automated policy-based 
payment process that will track APTC payments on an enrollee-by-
enrollee basis? If not, please explain the delay.

    If the new payment process has been launched, how many QHP issuers 
are using it? How many are not using it?

    Answer. In January 2016, CMS launched an automated payment 
approach, called policy-based payments, in determining an issuer's 
advance payment using enrollment and payment data in the Federally-
Facilitated Marketplace (FFM). This system calculates and tracks APTC 
on an enrollee-by-enrollee basis. As of December 2015, 93 percent of 
enrollees were enrolled with an issuer deemed ready to transition to 
policy-based payments.

    Question. If you have not launched the new automated system, have 
you implemented new policies and procedures to calculate and verify 
APTC payments that are independent of the attestations and assurances 
of QHP issuers? If not, why not?

    If so, please provide an explanation and any supporting 
documentation of these new policies.

    Answer. As stated above, CMS launched the policy-based payment 
system in January 2016.

    Question. Do you believe that HHS OIG's recommendation with respect 
to sharing APTC data with the IRS is unreasonable? If so, please 
explain.

    Do you plan on implementing HHS OIG's recommendation to share APTC 
data with the IRS for it to have the chance to independently verify 
this information? If not, why not?

    If so, how will you communicate this information to the IRS?

    Answer. Treasury regulations require each Marketplace to provide 
information to the IRS on a monthly basis about who is enrolled and the 
amount of APTC paid on the enrollees' behalf. Pursuant to these 
regulations, CMS provides this information regarding the Federal 
Facilitated Marketplace, and each State-based Marketplace provided this 
information about its own enrollees. This information is provided to 
the IRS securely through the Data Services Hub, which CMS maintains.

                                 ______
                                 
                 Questions Submitted by Hon. John Thune
    Question. I meet with members of South Dakota's nine tribes 
frequently and one of the main issues they have with the Indian Health 
Service (IHS) and the Federal Government at-large pertains to the lack 
of meaningful consultation by the Federal Government with the tribe. 
Please provide me with a copy of the IHS's policy for conducting 
consultation with tribal governments.

    If there is no official policy, please explain why and whether the 
IHS will create one within the next 6 months.

    Answer. IHS is committed to engaging with Tribal Governments and to 
transparency in the consultation process. Consistent with that 
commitment, our policy for conducting tribal consultation is publicly 
available at: https://www.ihs.gov/IHM/
index.cfm?module=dsp_ihm_circ_mainˆ=ihm_circ_0601.

    Question. In 2010, the Senate Committee on Indian Affairs released 
a report regarding the then-Aberdeen Area IHS office and detailed many 
issues regarding IHS interference with its employees speaking with 
members of Congress and members of tribal government. Often times, we 
hear stories of IHS employees being told that they are unable to speak 
directly to members of Congress or members of tribal government. During 
a recent hearing, the Director of the IHS indicated that there is a 
process in place to facilitate these conversations. As you know, 5 
U.S.C. Sec. 7211 prohibits interference with a Federal employee's 
communication with members of Congress.

    Please provide this committee with a copy of the policy in place 
regarding the facilitation of employee communication with Congress.

    Additionally, please provide an explanation from the Office of 
General Counsel regarding how this complies with 5 U.S.C. Sec. 7211.

    Answer. Consistent with 5 U.S.C. Sec. 7211, IHS policies and 
procedures do not prevent or prohibit any individual employee from 
providing information to Congress. IHS is committed to ensuring that 
the Congress receives timely, complete, and accurate information 
regarding IHS. Consistent with that commitment, and like most agencies, 
IHS routes requests from Congress through the IHS Congressional and 
Legislative Affairs Staff (CLAS) and/or the Office of theHHS Assistant 
Secretary for Legislation (ASL). The role of IHS legislative staff--
like legislative staff at other agencies--is to facilitate and 
coordinate responses, which may require input from different parts of 
IHS Headquarters, IHS Area Offices, or Service Units, and to ensure 
that the Congress receives timely, complete, and accurate information.

    Question. Please detail, by fiscal year, the amount of carry over 
funding for each fiscal year from 2010 to 2015.

    Answer. See attached table titled ``Indian Health Service No-Year 
Balance Authority.''

    Question. Do these funds return to IHS headquarters or are they 
retained at the regional offices?

    Answer. At the end of each fiscal year, unobligated balances in no-
year, or ``x,'' accounts are carried over to the next fiscal year. 
These carried over funds remain at the applicable organizational level 
that received or collected the funding. Third party collections are an 
example of no-year funds that are carried over from year to year and 
remain available to the organizational level that collected the funds.

    Question. Is there a policy in place for how this carry over 
funding is to be utilized in future fiscal years? If yes, please 
provide the committee with a copy of that policy.

    Answer. The use of carryover funds is directed by the relevant 
appropriations bills--no-year funds continue to be used for the 
purposes for which they were appropriated--and other authorizing 
legislation (e.g., the Social Security Act, IHCIA, etc.). In 
particular, the IHCIA states that health care service payments under 
the Social Security Act, from the VA, and from third party providers 
are credited to the account of the program that provided the services 
and must be used to maintain accreditation and compliance with CMS 
conditions and requirements for participation.

    Question. Of the total amount of IHS Equal Employee Opportunity 
(EEO) complaints filed, how many result in mediation?

    Answer. From FY 2010 through FY 2015, of the total number of EEO 
complaints filed, 30 (2%) resulted in mediation, a method of 
Alternative Disputes Resolution (ADR).

    Question. Following mediation, is the complaint noted within the 
employee record?

    Answer. Information related to EEO complaints is not made a part of 
the official employee file to assure the confidentiality of the EEO 
process. EEO case information is to be safeguarded and the 
confidentiality maintained of those who participate in the EEO process 
to avoid having an adverse effect on the EEO process, as well as lead 
to the distinct possibility of giving rise to a claim of retaliation. 
IHS notes in the EEO Complaint File that ADR was conducted, and also 
notes the results of the ADR. If the parties reach an agreement, then 
the case is closed and entered into the Diversity Management/Equal 
Employment Opportunity (DM/EEO) database as a Settlement Agreement.

    Question. Anecdotally, I have been informed that many of these 
mediations result in a settlement in which the complainant signs a 
nondisclosure agreement. Please provide the committee with any 
information regarding mediations that have resulted in these 
nondisclosure agreements.

    Answer. All Settlement Agreements entered into between the 
Complainant and IHS are private and confidential and not subject to 
disclosure. Specific portions of the confidential Agreement may be made 
available to the parties responsible for implementation of specific 
terms of the Agreement.

    Question. Please provide the committee with the most recent data 
available regarding the amount of Federal funds used to reach a 
settlement agreement following an EEO complaint.

    Answer. The amount of Federal funds used to resolve informal and 
formal complaints is provided in the following table.


----------------------------------------------------------------------------------------------------------------
     FY 2010            FY 2011            FY 2012            FY 2013            FY 2014            FY 2015
----------------------------------------------------------------------------------------------------------------
$313,991.00             $433,372.59        $396,748.20        $880,225.46        $888,448.00        $385,300.15
----------------------------------------------------------------------------------------------------------------


    Question. Please provide the committee data regarding any and all 
moving expenses reimbursed by IHS to employees that are relocated 
subsequent to an EEO complaint.

    Answer. From FY 2010 through FY 2015, the total amount of moving 
expenses reimbursed by IHS to employees was $27,537.

    Question. Which funding sources within the GPA IHS are used for 
mediation settlements?

    Answer. The Department of Justice Judgment Fund (Fund) is the 
initial funding source. However, the amount paid by the Fund must be 
reimbursed by the Indian Health Service (IHS). IHS recovers the funds 
from the specific Area where the Complainant was employed (i.e., where 
the EEO complaint was filed). Specific funding sources include private 
insurance collections, Hospitals and Clinics, Alcohol and Substance 
Abuse, and Facilities Support.

    Question. Please provide data (most recent available) and 
information for the following questions related to performance-based 
awards/bonuses and recruitment incentives paid to employees by the IHS:

    Answer. All responses are based on CY 2015 recruitment incentive 
data and bonus award data paid in CY 2015 for the 2014 employee 
performance year. The attached document provides guidance on awards. 
Bonus awards are allocated by the Department and are subject to 
collective bargaining and Federal performance management policy and 
regulation.

    Question. How many IHS employees received performance-based awards/
bonuses?

    Of the total, how many members of the Senior Executive Service 
(SES) of the IHS received such awards/bonuses?

    Of the total, how many employees within the Great Plains Area (GPA) 
IHS received such awards/bonuses?

    Of the total, how many SES members within the GPA IHS received such 
awards/bonuses?

    Answer. For the CY 2014 employee performance based evaluation 
period, a total of 4,441 IHS employees received performance-based 
awards. Of this total,

          Twelve SES members in IHS received such awards.
          Four hundred eighty three employees in the GPA IHS received 
        such awards.
          No SES members within the GPA IHS received any awards.

    Question. What is the average amount of a performance-based award/
bonuses paid to (i) IHS employees, (ii) SES members, (iii) employees 
within the GPA IHS, and (iv) SES members within the GPA IHS?

    Answer. For the CY 2014 employee performance based evaluation 
period, the average performance-based awards paid to IHS employees was 
$1,028.

    For the CY 2014 employee performance based evaluation period, the 
average performance-based awards paid to SES members (their evaluation 
period is FY) in IHS was $9,159.

    For the CY 2014 employee performance based evaluation period, the 
average amount of a performance-based awards paid to employees within 
the GPA IHS was $1,000.

    For the CY 2014 employee performance based evaluation period, no 
SES members in the GPA IHS received any performance-based awards.

    Question. What is the total amount of appropriated funds allocated 
to performance-based awards/bonuses within IHS?

    What is the total amount of appropriated funds allocated to such 
bonuses for SES members?

    What is the total amount of appropriated funds allocated to such 
bonuses for employees within the GPA IHS?

    What is the total amount of appropriated funds allocated to such 
bonuses for SES members within the GPA IHS?

    Answer. The total amount of appropriated funds allocated for CY 
2014 employee performance based awards within IHS was $8,228,261.

    The total amount of appropriated funds allocated to such 
performance-based awards for SES members was $143,900.

    The total amount of appropriated funds allocated to such 
performance-based awards for employees within the GPA IHS was 
$1,255,291 for awards.

    The total amount of appropriated funds allocated to such 
performance-based awards for SES members within the GPA IHS was $7,600, 
however, these funds were not awarded.

    Question. Which funding sources within the GPA IHS are used for 
employee bonuses?

    Answer. The GPA IHS employee bonuses are funded by either the 
Hospitals and Clinics or Direct Operations appropriations lines 
depending on which account is used to pay the employee's salary.

    Question. To what extent does IHS use authority (e.g., 5 U.S.C. 
Sec. 5753) to provide recruitment incentives to employees?

    Answer. IHS uses this authority to the maximum extent possible. It 
is critical for recruiting clinicians to IHS sites in isolated and 
remote locations.

    Question. Please describe (and provide relevant documents on) the 
policies on recruitment incentives for (i) employees and (ii) members 
of the SES at IHS.

    Answer. IHS follows the Recruitment, Retention, and Relocation 
policy located in the Indian Health Manual for the payment of 
recruitment incentives for all employees, including SES positions. This 
policy may be found at https://www.ihs.gov/ihm/
index.cfm?module=dsp_ihm_ pc_ p7c8.

    Question. How many IHS employees received a recruitment incentive?

    Of the total, how many members of the SES received a recruitment 
incentive?

    Of the total, how many employees within the GPA IHS received a 
recruitment incentive?

    Of the total, how many SES members within the GPA IHS received a 
recruitment incentive?

    Answer. For CY 2014, 258 IHS employees received a recruitment 
incentive.

    For CY 2014, no (0) SES employees (their performance period is on 
the FY) received a recruitment incentive.

    For CY 2014, 25 employees within the Great Plains Area (GPA) Indian 
Health Service (IHS) received a recruitment incentive.

    For CY 2014, no (0) SES employee within the GPA IHS received a 
recruitment incentive.

    Question. What is the average amount of a recruitment incentive 
paid to (i) IHS employees, (ii) SES members, (iii) employees within the 
GPA IHS, and (iv) SES members within the GPA IHS?

    Answer. The average recruitment incentive paid to IHS employees was 
$11,169.

    No recruitment incentives were paid to SES members.

    The average recruitment incentive paid to employees within the GPA 
IHS was $12,190.

    No recruitment incentives were paid to SES members within the GPA 
IHS.

    Question. If recruitment incentives have not been paid within the 
last 3 years to (i) IHS employees, (ii) SES members, (iii) employees 
within the GPA IHS, and (iv) SES members within the GPA IHS, please 
provide a detailed explanation as to the reasons why not.

    Answer. Recruitment incentives were not paid within the last 3 
years to SES members of IHS nor to SES members within the GPA IHS 
because IHS did not hire anyone from outside the Federal Government and 
IHS has been able to fill its positions within the basic salary rates 
for members of the SES.

                                 ______
                                 
               Questions Submitted by Hon. Johnny Isakson

    Question. CBER, or the Center for Biologics Research and 
Evaluation, has issued a series of Untitled Letters related to product 
classification of tissue products. FDA's Regulatory Procedures Manual 
explains that an Untitled Letter ``cites violations that do not meet 
the threshold of regulatory significance for a Warning Letter. 
Therefore, the format and content of an Untitled Letter should clearly 
distinguish it from a Warning Letter.'' Unfortunately, several of these 
recent CBER Untitled Letters are not distinguishable at all from 
Warning Letters. Because CBER posts these documents on its website and 
they are read exactly like Warning letters, these Untitled Letters have 
caused great disruptions and uncertainty for industry including damage 
to companies.

    Why has FDA begun issuing Untitled Letters rather than trying to 
have a dialogue with the company first about the product 
classification?

    Answer. HHS is committed to minimizing disruption and uncertainty 
for industry while balancing safety concerns for consumers. In this 
vein, FDA's Untitled Letters often serve as the initial communication 
with regulated industry concerning regulatory violations. But, FDA also 
uses other means to communicate and resolve questions with 
manufacturers.

    One example of these communications is the Center for Biologics 
Evaluation and Research's (CBER) Tissue Reference Group (TRG), which 
assists stakeholders on questions regarding human cell tissues and 
cellular and tissue based products (HCT/Ps). The purpose of the TRG is 
to provide a single reference point for product specific questions 
received by FDA concerning jurisdiction and applicable regulation of 
HCT/Ps. FDA has publically posted information on how manufacturers can 
submit inquiries to the TRG and publically discloses information 
related to TRG recommendations on the CBER website.

    If FDA issued an Untitled Letter subsequent to an establishment 
inspection, the FDA investigator may have already informally discussed 
the situation, though the investigators are not required to do so. In 
determining whether to issue an Untitled Letter, FDA officials 
generally consider whether evidence shows that a firm, product, and/or 
individual is in violation of the law or regulations. Such evidence may 
have been obtained during a routine or directed inspection, or other 
means of surveillance, such as Internet website surveillance.

    FDA issues Untitled Letters to serve as correspondence with 
regulated industry for violations that do not rise to the threshold of 
a warning letter, but which do merit mention. Untitled Letters are not 
limited to potential product classification issues but are generally a 
mechanism to communicate and to provide notice of a violation. These 
letters ordinarily provide the factual basis regarding the violation 
and serve to communicate the concern without committing FDA to 
enforcement action if the violation is not corrected.

    Question. Why is FDA insistent that such letters must be posted on 
their website?

    Answer. FDA has Center-specific policies as to whether to post 
Untitled Letters, except to the extent that it overlaps with FDA's 
approach to proactive posting under the Freedom of Information Act 
(FOIA). We are committed to minimizing disruption and uncertainty for 
industry while balancing safety concerns for consumers.

    FDA's posting approach under FOIA requires the posting of any FDA 
record subject to the FOIA, such as an Untitled Letter if:

          FDA has received three or more FOIA requests for a copy of 
        the record, or

          If the matter is of significant public interest and we 
        expect to receive multiple FOIA requests for it.

    This approach is consistent with Federal law, guidelines from the 
Department Justice, President Obama's January 21, 2009 FOIA Memorandum, 
and Attorney General Holder's March 19, 2009 Memorandum.

    Question. In light of the above, are you willing to review your 
process for Untitled Letters, especially as it relates to product 
reclassifications, and examine ways to make issuance of these letters 
fairer, more effective and more consistent?

    Answer. FDA is currently reviewing processes for issuing and 
posting Untitled Letters for FDA and each of the Centers. Specifically, 
it is reviewing ways that Agency and Center policies could be made more 
accessible and transparent. We will keep your staff informed as this 
process progresses.

    Question. What are some procedural protections the agency might 
consider in this space?

    Answer. FDA believes in transparency and consistency in its 
procedures. Although FDA recognizes that some stakeholders want greater 
uniformity in practices related to posting Untitled Letters, our 
product centers need to maintain some specific procedures to address 
the particulars of the products they regulate, taking into account 
available Center resources. Currently, a group with representatives 
from each of the product centers in FDA is collecting and analyzing the 
policies and looking for common practices to examine ways to create 
consistent policy here while allowing flexibility where needed for each 
Center or program.

    Question. The American Association of Tissue Banks (AATB) made CBER 
aware on numerous occasions that it was preparing a homologous use 
guidance proposal for FDA's consideration. That AATB proposal was to be 
discussed at the AATB-FDA liaison meeting on October 29, 2015. Given 
the exchange of agendas and meeting materials in the weeks leading up 
to the meeting, the agency was well aware of this scheduled discussion. 
However, around 5 PM on October 28th, FDA posted its own homologous use 
draft guidance. This had the effect of rendering any substantive 
conversation about the AATB guidance impossible, as the subject matter 
was now part of an open docket which FDA cannot discuss while the 
comment period remains open.

    Why did FDA choose to release this guidance just hours before the 
scheduled discussion with AATB, which limited the ability to have a 
meaningful discussion?

    Will FDA evaluate AATB's proposed guidance document during the 
comment period?

    In what area is there alignment between the AATB proposed guidance 
and FDA's draft guidance?

    Answer. Thank you for your question. The guidance was released as 
soon as it was ready for release. FDA was receptive to the comments 
from the American Association of Tissue Banks (AATB) regarding the 
proposed guidance and looks forward to AATB's contributions through 
written comments on the guidance and at the upcoming public meeting.

    As always, FDA will evaluate all comments regarding this guidance 
that are received, including AATB's proposed guidance, which FDA 
encouraged AATB to submit to the docket.

    Both AATB's and FDA's documents share the goal of developing better 
clarity to help facilitate the development of HCT/Ps. FDA will 
carefully review the AATB proposal, as well as other comments received. 
In addition, FDA is having an open public hearing in 2016. Information 
on the hearing, including date, location and registration information, 
will be made available on FDA's website and will be published in the 
Federal Register.

    Question. Trauma remains the leading cause of death under age 45. 
You received a comment letter that proposed to test and model, at least 
on a short-term basis, establishing three HCPCS codes specifically for 
trauma: (1) trauma high severity potentially life threatening; (2) 
trauma high severity life threatening; and (3) trauma critical care. 
This methodology would fold in the existing G0390 code for trauma team 
activation.

    Has CMS modeled this proposal or does CMS have plans to do so and 
share publically?

    Answer. We appreciate the importance of ensuring that individuals 
have access to quality trauma care. The Center for Medicare and 
Medicaid Innovation (Innovation Center), as authorized by section 1115A 
of the Social Security Act, tests innovative payment and service 
delivery models to reduce program expenditures while preserving or 
enhancing the quality of care. The Innovation Center is always open to 
new ideas for testing models. We would be happy to learn more about the 
trauma proposal.

    Question. (Submitted jointly for Senators Isakson and Warner) The 
Medicare program appears to be missing opportunities to adopt 
approaches that have been proven in the private sector to both save 
money and promote community-based care. A good example of this is home 
infusion therapy, which is widely covered by commercial payers as a 
means of keeping patients out of institutions for their infusion 
treatments. Home infusion therapy, as opposed to some other sites of 
care, allows patients the opportunity to receive treatment in a more 
cost effective, convenient and clinically beneficial setting. Private 
payers also have reaped the benefits of reducing hospital acquired 
infections, which HHS has devoted substantial resources to curb. We 
have introduced the Medicare Home Infusion Site of Care Act of 2015 to 
address the lack of coverage for home infusion. This year we are 
working with CMS to address logistical and operational issues to ensure 
that the legislation can be implemented effectively and efficiently.

    We ask for your agency's continued cooperation and support on this 
legislation for Medicare coverage of infusion treatments in the home.

    Answer. Thank you for raising this important issue. Coordinating 
care is a cornerstone of the work the Department is doing around 
delivery system reform. Our goal is to foster a health care system that 
leads in innovation, delivers the most affordable, highest quality 
medicines and results in healthier people. We are happy to continue to 
work with you and provide technical assistance on the legislation.

    Question. I understand that appropriated funding has not been 
adequately directed toward providers for preparedness at levels that 
Academic Health Centers (AHCs) feel are clinically necessary. Further, 
I understand that the Zika virus falls into the preparedness bucket, 
which the Federal Government has been underfunding.

    Can you tell me specifically how this will be addressed/corrected?

    How do we redirect funding already appropriated to address the 
emerging Zika virus public health emergency?

    Answer. A total of $208 million of Ebola emergency funding 
appropriated to the Public Health and Social Services Emergency Fund 
was allocated to support the Hospital Preparedness Program to health 
care system preparedness and response to Ebola virus in the U.S. While 
the primary focus of the Hospital Preparedness Program Ebola funding is 
on preventing, preparing for, and responding to Ebola, as required by 
title VI of Division G of the Consolidated and Continuing 
Appropriations Act, 2015, it is likely that preparedness for other 
novel, highly pathogenic diseases will also be enhanced through these 
activities. While HHS provides funds and provides guidance, ultimately 
decisions on the levels of funding for Ebola treatment centers are made 
by the program's 62 awardees, the health departments in all 50 States, 
the District of Columbia, Chicago, Los Angeles County, New York City, 
and all U.S. territories and freely associated States. Funding 
allocations for HPP's Ebola funds were based on a formula that 
accounted for population and Ebola risk. The hospital preparedness 
supplemental funding also provided significant resources to establish 
nine regional Ebola and other special pathogen treatment centers. These 
facilities have enhanced capabilities to ensure they are the leading 
providers of care and treatment for Ebola patients in the U.S. and have 
the capabilities needed to manage other high containment, Ebola-like 
infectious diseases in the future.

    With the funding provided, States will be able to support treatment 
facilities, including academic health centers and other hospitals, 
support a broad range of preparedness activities such as caring for 
clinical complex patients; maintaining enhanced readiness through 
increased training; increasing capacity to handle highly contaminated 
infectious waste; receiving and participating in training, peer review, 
and assessment of readiness to ensure adequate preparedness, develop 
strategies to ensure health care worker readiness and safety; and 
integrate behavioral health considerations for patients and staff.

    In order to respond to the Zika virus both domestically and 
internationally, the administration has requested $1.9 billion in FY 
2016 emergency supplemental funding. This supplemental includes a 
requested $1.5 billion to support domestic and international activities 
across HHS. This funding would support immediate response activities to 
prevent the spread of, prepare for and respond to Zika virus 
transmission; fortify domestic public health systems to prevent, 
detect, and respond to Zika virus transmission; speed research, 
development, and procurement of vaccine, therapeutics, and diagnostics; 
provide emergency assistance to States and the U.S. territories to 
combat the virus; provide additional Federal Medicaid funding in Puerto 
Rico and the other U.S. territories for health services for pregnant 
women at risk of infection or diagnosed with Zika virus, and for 
children with microcephaly, and for other health care costs; and 
enhance the ability of Zika-affected countries to better combat 
mosquitoes, control transmission, and support affected populations. In 
addition, the supplemental Zika funds would allow HHS to complete the 
ongoing work being supported.

    Question. I understand FDA is now requiring that manufacturers of 
over-the-counter sunscreen products perform a Maximum Use Trial (MUsT) 
in order to gain product approval. It is also my understanding that 
MUsT has never been required for sunscreen products in the past.

    Answer. FDA is committed to preventing and treating skin cancer, 
and is implementing the Sunscreen Innovation Act (SIA) with the goal of 
providing consumers with access to sunscreen products that are safe and 
effective. The combination of a large increase in the amount and 
frequency of sunscreen usage, together with advances in scientific 
understanding and safety evaluation methods, has given rise to the need 
for additional data to support FDA's determination that an over-the-
counter (OTC) sunscreen active ingredient is generally recognized as 
safe and effective for use in OTC sunscreen products.

    FDA is recommending that sponsors of currently pending and future 
sunscreen active ingredients reviewed under the pathway provided by the 
SIA perform a human absorption study/maximal usage trial (MUsT) as part 
of the safety data submitted to show that an active ingredient is 
generally recognized as safe and effective (GRASE) for use in 
nonprescription sunscreen products and can be included in the OTC 
sunscreen monograph. Once FDA has determined that a given ingredient is 
GRASE on the basis of a MUsT and other safety and efficacy data, we do 
not expect that additional MUsT studies would be necessary for OTC 
products formulated using that ingredient and otherwise complying with 
monograph conditions.

    The purpose of the MUsT is to evaluate whether and the extent to 
which a topically applied active ingredient is absorbed into the body. 
This is a critical safety consideration for nonprescription sunscreens 
because they are intended for chronic use, i.e., they are applied 
regularly over a large portion of the body whenever consumers are 
exposed to the sun throughout their lifetimes. The information from a 
MUsT can help identify potential safety concerns and help determine 
whether an adequate safety margin exists for an active sunscreen 
ingredient to be included in the OTC sunscreen monograph.

    The FDA has required a MUsT for the new drug applications (NDA) 
approval of a nonprescription sunscreen product containing ecamsule, 
performed according to the science as understood at the time the NDA 
was approved in 2006. The MUsT approach is consistent with how 
consumers use these products, and also with FDA's review of both 
nonprescription and prescription topical drugs intended for chronic 
use. In particular, it is the same approach FDA proposed in December 
2013 for safety testing of OTC consumer antiseptic washes marketed 
under the OTC monograph system, and in May 2015 for OTC health care 
antiseptics marketed under the OTC drug monograph system. MUsT data 
also have been relied on since the mid-1990s to support FDA's clinical 
pharmacology/bioavailability assessment approval of new drug 
applications (NDAs) for chronic-use topical products.

    Question. Please detail the requirements that need to be met in the 
MUsT Test.

    Answer. FDA's current thinking about the conduct and evaluation of 
sunscreen MUsTs is described in draft guidance and proposed sunscreen 
orders issued in 2015 by requirement of the Sunscreen Innovation Act 
(SIA). Copies of the draft guidance and proposed sunscreen orders can 
be found at: http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/ucm434843.htm.

    Question. What is it that companies must show in the MUsT test that 
cannot be shown in existing data collected by sunscreen manufactures?

    Answer. Even though the protective action of sunscreen products 
takes place on the surface of the skin, current evidence suggests that 
at least some sunscreen active ingredients may be absorbed through the 
skin into the body, making it important to complete studies to 
determine whether, and to what extent, absorption occurs. If more than 
a minimal amount of absorption is observed, additional studies may be 
needed to determine whether there is a risk of long-term health effects 
that would offset the sun protection benefits of sunscreen products 
using that ingredient. This is particularly important because we 
recognize that sunscreens are used very broadly by the whole 
population, even on children as young as 6 months of age and in 
pregnant and lactating women.

    The existing data collected by the sunscreen manufacturers does not 
adequately assess the extent of absorption in humans and thus enable an 
accounting of human systemic exposure for risk assessment.

    FDA has evaluated the existing data and communicated 
recommendations for additional studies for eight sunscreen active 
ingredients through proposed sunscreen orders under the SIA. In 
addition, FDA met with all sponsors of these ingredients who requested 
a meeting to discuss the studies necessary to support a GRASE 
determination for their specific ingredients, including the importance 
of a MUsT and the limitations of alternative approaches proposed to 
date. The data submitted as of February 11, 2016, do not provide 
sufficient information for FDA to evaluate whether and the extent to 
which an ingredient is absorbed into the body.

    Question. Making the MUsT Test a pre-requisite for approval of a 
sunscreen ingredient through the TEA process means delays in consumer 
access to products already available all over the world to protect 
against skin cancer. How does HHS plan to address the risk-benefit 
balance between additional testing of products already in use against 
the need for more tools to protect against the growing public health 
threat of skin cancer, the most common form of concern in the world?

    Answer. Given the recognized public health benefits of sunscreen 
use, the FDA is committed to finding ways to facilitate the marketing 
of sunscreen products that include additional OTC sunscreen active 
ingredients. To do so, the FDA must balance the public health benefits 
of access to a broader range of sunscreen active ingredients against 
the importance of providing an adequate margin of safety for products, 
such as sunscreens, that are marketed for regular use. Although 
sunscreens are regulated as cosmetics in the European Union and 
elsewhere, in the U.S., they are classified as drugs because they are 
intended to decrease the risk of sunburn. Sunscreens marketed under the 
OTC monograph system that meet certain final formulation efficacy 
requirements are permitted to be labeled for use to decrease the risks 
of skin cancer and early skin aging caused by the sun when used as 
directed with other sun protection measures. Drug products marketed to 
American consumers must satisfy safety and effectiveness requirements 
that Congress established under the Federal Food, Drug, and Cosmetic 
Act.

    FDA's data requests are in line with the safety data the agency 
currently seeks for topical drugs in general under both new drug 
reviews and the OTC monograph process. Understanding whether and to 
what extent a drug is absorbed into the body is a key element in the 
benefit-risk determination for all drugs, including those administered 
via the topical route. Of note, MUsT studies are not long-term clinical 
trials; for most ingredients, it is expected that the duration of the 
MUsT will be only a few days, depending on the metabolism of the 
particular drug. With respect to the extent of delay potentially 
created by the recommendation to conduct a MUsT, based on prior 
experience with other topical drug products FDA believes that the 
approximate time needed for a sponsor to conduct a MUsT and submit a 
completed report is less than 6 months, a timeframe shorter than that 
which has already elapsed since manufacturers received FDA's 
recommendations. We also note that, although the SIA imposes strict 
time frames for FDA's review of safety and efficacy data, it does not 
address the timing of data submissions by active ingredient sponsors or 
other interested parties. As a result, the timing of FDA's final GRASE 
determinations for pending and future sunscreen active ingredients will 
largely be determined by how quickly sponsors are able to provide the 
data necessary to support a finding that a sunscreen containing a 
particular active ingredient would be GRASE.

                                 ______
                                 
             Questions Submitted by Hon. Patrick J. Toomey
                              opioid abuse
    Question. In its FY 2017 budget request, HHS seeks authority from 
Congress to authorize Medicare prescription drug plans to ``lock in'' 
beneficiaries who are abusing prescription opioids to a single provider 
and pharmacy. Senators Brown, Portman and I have introduced the 
bipartisan Stopping Medication Abuse and Protecting Seniors Act to give 
CMS this authority. It would affect only a small number of 
beneficiaries--less than 1 percent--who have a record of frequenting 
multiple prescribers to obtain excessively high, unsafe amounts of 
prescription painkillers. This legislation will help to address a 
growing problem in my State.

    The intention of our bipartisan legislation is to stop fraudulent 
diversion and help improve the quality of care for those who are 
addicted. It also allows the at-risk beneficiary to select a pharmacy 
they would like to use. Beneficiaries are ``locked in,'' not out, from 
a pharmacy. As you may know, this ``lock-in'' approach is successfully 
utilized by nearly all State Medicaid programs and commercial insurers. 
It has reduced fraud and improved care. For example, those in 
Oklahoma's ``lock in'' programs used fewer narcotics and saw declines 
in emergency department visits.

    When a pharmacy is unable to fulfill a Medicare prescription, a 
Part D plan sponsor can make a ``point of sale'' edit to allow the 
beneficiary to use another pharmacy. Such would be the case in the rare 
circumstance that a beneficiary could not access narcotics from their 
preferred pharmacy under S. 1913.

    At your appearance, you referenced the need to ensure beneficiaries 
with legitimate pain medication needs maintain access to controlled 
substances. Were you speaking about the broader issue of pharmacies 
that have imposed their own restrictions on opioid dispensing in order 
to mitigate possible attention from law enforcement, and if so, does 
HHS plan to take any action in this area?

    Answer. First, I would like to thank you and Senator Brown for your 
leadership on this issue. As you note, this proposal is included in our 
budget and we would be happy to work with you on it. HHS is working 
with many partners, including pharmacies, to address the problem of 
opioid overdose, death, and dependence. When HHS developed its Opioid 
Initiative, we were keenly aware of the necessity to balance the needs 
of patients living with pain with the public health goals of reducing 
opioid overdose, death, and dependence. Chronic pain impacts the lives 
of millions of Americans and we must support evidenced-based treatment 
of pain. However, there has been an over-reliance on prescription 
opioid pain medications and this has resulted in alarming increases in 
prescription drug overdose, death, and dependence. We know that certain 
patients do benefit from these powerful medications, so our efforts to 
reduce opioid overdose must not create barriers for them.

    There are many reasons for our over-reliance on prescription 
opioids but one is the lack of provider education and clinical tools to 
help guide safe and appropriate opioid prescribing. Our Initiative at 
HHS is making investments to provide clinicians with the education and 
tools they need to make informed prescribing and treatment decisions. 
This is a critical first step in driving down the opioid problem and 
ensuring that patients living with pain receive the most effective and 
appropriate care.

    The 2016 CDC Guidelines for Opioid Prescribing for Chronic Pain, 
currently under development, is one example of the tools we are 
developing for providers. These guidelines, which are targeted for 
primary care providers treating chronic pain in adults outside end of 
life care, aim to improve pain management and safety for patients and 
provide clinicians with factors to consider when determining the 
appropriate treatment for their patient, which includes the use of 
prescription opioids. They will provide clinicians with important 
information that can facilitate safer treatment and maximize the 
benefits their patients receive from their pain treatment regimen.

    To address the issue of pain more broadly, HHS is also in the 
process of developing a National Pain Strategy that outlines priorities 
for population level research on pain, enhancing provider education on 
pain and its management, improving patient access to evidence-based 
multidisciplinary pain prevention and care approaches, and implementing 
payment incentives that provide for quality pain care.

    Pharmacies are also important partners in our efforts, particularly 
around training and education as well as naloxone access. In October 
2015, the President announced Federal, State, local and private sector 
efforts aimed at addressing the prescription drug abuse and heroin 
epidemic. This announcement included commitments from pharmacy chains 
and several pharmacy organizations:

          The American Pharmacists Association, with an outreach 
        capability of more than 250,000 individuals, will educate 
        pharmacists, student pharmacists, and stakeholders through a 
        new Resource Center on opioid use, misuse, and abuse.
          The American Society of Health-System Pharmacists will 
        provide training and resources to 40,000 pharmacists, student 
        pharmacists, and pharmacy technicians.
          The National Association of Boards of Pharmacy will enhance 
        access to prescription drug monitoring program data for 
        thousands more physicians and pharmacists in Arizona, Delaware, 
        Kentucky, and North Dakota in 2016.
          CVS Health will allow CVS/pharmacy to dispense naloxone 
        without patients needing to present an individual prescription 
        pursuant to a standing order from a physician or collaborative 
        practice agreement in an additional 20 States in 2016 and will 
        launch a new drug abuse prevention program called Pharmacists 
        Teach, where its pharmacists will make 2,500 presentations in 
        high school health classes.
          Rite Aid will train 6,000 pharmacists on naloxone use over 
        the next 12 months, and expand their naloxone dispensing 
        program to additional States.
          The National Association of Chain Drug Stores will continue 
        to educate their 125 chain member companies (40,000 pharmacies 
        with 175,000 pharmacists) about opioid overdose and naloxone.
          The National Community Pharmacists Association, representing 
        23,000 pharmacies with over 62,000 pharmacists, will be 
        distributing inserts to community pharmacists that highlight 
        safe drug disposal and naloxone.

    It should also be noted that HHS continues to work closely with the 
White House Office of National Drug Control Policy, as well as our 
colleagues at the Department of Justice to ensure a coordinated Federal 
response that best leverages our resources to effectively implement 
strategies that reduce the impact of opioid use disorders and overdose.
                          the 25 percent rule
    Question. In 2013, Congress enacted a new set of criteria for 
patients receiving care at long-term acute care hospitals. Congress 
also continued to prohibit CMS from adopting a 2007 regulation that 
would require LTCHs to rely upon at least four feeder hospitals who 
would be discharging or transferring patients. This is known as the 25% 
rule. Congress was concerned that many LTCHs would be unable to comply 
given that their communities do not have four major hospitals. Thus, 
LTCHs, especially in Pennsylvania, would be forced to close and 
critically ill seniors would be without high-quality post-acute care. 
As you may know, the statutory prohibition on the 25 percent rule 
expires in July.

    In a congressionally directed report on LTCH payment policy from 
July 2015, CMS stated that ``given the significant payment changes to 
the LTCH PPS . . . we believe it would be advantageous to analyze the 
impact of the implementation of a revised payment system including the 
introduction of site neutral payment rates to the LTCH PPS prior to 
considering further extensions (or modifications of the extensions) of 
the suspension of the 25 percent policy.'' In this context, the 
operative policy is the 50 percent rule enacted by Congress since the 
25 percent rule has not been in effect since 2007.

    Furthermore, CMS goes on to state that any extensions or 
modifications would be dependent on analyzing admissions data under the 
revised payment system (i.e., site neutral).

    Given CMS's reasonable view of the change in the LTCH sector, and 
the establishment of site-neutral, criteria-based reimbursement for 
LTCHs, why would CMS choose to implement a regulation that has been 
dormant for nearly a decade?

    I've introduced legislation along with Senator Michael Bennet to 
maintain the existing 50 percent rule for two more years, giving CMS 
the time needed to evaluate admissions data in the current LTCH 
environment. Our bill is the Preserving Patient Access to Post-Acute 
Hospital Care Act (S. 2108). I would welcome technical assistance from 
HHS-CMS on our legislation as Congress and the Executive Branch 
consider whether the 25 percent rule is even necessary given the new 
patient criteria requirements.

    Answer. Being from West Virginia, rural health is a priority for me 
as Secretary. HHS remains dedicated to improving access to quality 
health care for rural Americans.

    As you know, the new clinical criteria for long-term care hospitals 
(LTCHs) just took effect in fiscal year 2016. In considering the 
potential policy proposals, CMS recognized that there is a current 
statutory moratorium on the full implementation of the 25-percent 
threshold payment adjustment policy under the statute that is scheduled 
to expire in FY 2016. The 25-percent threshold payment adjustment 
policy was implemented based on analyses of Medicare discharge data 
that indicated that patterns of patient shifting appeared to be 
occurring more for provider financial advantage than for patient 
benefit. In order to discourage such activity, a payment adjustment was 
applied to LTCH discharges of patients who were admitted to the LTCH 
from the same referring hospital in excess of an applicable percentage 
threshold CMS believes that the site neutral payment rate will not 
address these patient shifting concerns unless the 25-percent threshold 
payment adjustment is applied to site neutral payment rate cases in the 
same manner as it is applied to LTCH PPS standard Federal payment rate 
cases.

    The policy also provides for special treatment of rural, urban 
single, and Metropolitan Statistical Area (MSA)-dominant hospitals. In 
the case of an LTCH that is located in a rural area, the applicable 
threshold is set at 50 percent instead of 25 percent. For an LTCH that 
admits Medicare patients from the only other hospital in the MSA or 
from a MSA-dominant hospital, the payment threshold can vary between 25 
percent and 50 percent, and would be equal to the percentage of total 
Medicare discharges in the MSA from the MSA-dominant hospital during 
the LTCH's cost reporting period.

    It is too early to know whether these criteria will accomplish the 
goals of the new payment system. We need some experience under the new 
system first before we revisit the 25 percent rule. CMS believes it is 
prudent to maintain these policies as they currently exist while the 
agency gains experience and finalizes its proposal to apply the 25-
percent threshold policy to site neutral payment rate cases. In the 
event that policy modifications are warranted, CMS would address them 
through future rulemaking.

    We are happy to work with you and provide technical assistance on 
the legislation.
                            federal exchange
    Question. CMS stated in its Notice of Benefit and Payment 
Parameters for 2017 that user fee collections will not be sufficient to 
cover Exchange operations in 2017, and was seeking an OMB waiver so CMS 
could use other monies to finance the Exchange. In the FY17 budget 
request, HHS estimated the need for $535 million in appropriations to 
help operate the Exchange.

    Please provide any advisory opinions, memorandums, or communication 
from the CMS Office of General Counsel about the use of user fees for 
exchange operations versus Secretarial activities that could not be 
covered by user fees.

    Answer. Eligibility for user fees is determined under Office of 
Management and Budget (OMB) Circular A-25R and must ``cover all Federal 
activities that convey special benefits to recipients beyond those 
accruing to the general public.'' The preamble to the Notice of Benefit 
and Payment Parameters explains how Marketplace user fee policy 
complies with this guidance, and this language is reviewed and cleared 
by HHS OGC as part of the regular regulatory review process. The $535 
million requested in the President's budget funds the cost of 
conducting activities that cannot be funded by the user fee. These 
activities provide services to all Marketplaces and SHOPs whether they 
are operated by the State or CMS, and therefore do not meet the 
``special benefit'' test. Activities that are not eligible to be funded 
through user fees include: payment of financial assistance to issuers, 
eligibility verification services provided through the Data Services 
Hub (DSH), quality reporting, and some eligibility appeals. CMS 
regularly reviews allocable activities that provide support to both 
eligible and non-eligible activities to ensure all eligible activities 
are appropriately funded via the user fee. CMS, however, will always 
require some amount of discretionary appropriated budget authority to 
conduct non-eligible activities.

    Question. In Medicare, Medicaid and the private sector, health care 
delivery and payment systems are witnessing significant and 
accelerating change. Yet the Program of All-Inclusive Care for the 
Elderly (or PACE), which pioneered so many of the features we now seek 
to build into our health care system, is being constrained by 
regulations that are almost a decade old. What is the administration 
doing to update those regulations and provide more flexibility to PACE 
so that seniors can have greater access to this model of integrated, 
community-based and person-
centered care?

    Answer. I share your support for the PACE program and CMS is taking 
steps to modernize and streamline PACE enrollment and services.

    PACE has proven successful in keeping frail elderly individuals in 
the community, and we agree that we should revise certain regulatory 
provisions to afford more flexibility as a means to encourage the 
expansion of the PACE program to more States, increase access for 
participants, and further enhance the program's effectiveness at 
providing care while reducing costs. CMS is proposing to revise and 
update policies to reflect subsequent changes in the practice of caring 
for PACE participants and changes in technology based on our experience 
implementing and overseeing the PACE program. CMS has received numerous 
suggestions from PACE organizations, beneficiaries, members of 
Congress, and other stakeholders and looks forward to working with all 
stakeholders throughout the rulemaking process.

    CMS is dedicated to continuing exploring new opportunities and 
ideas to further strengthen PACE programs and services.

    Question. Recently, Congress enacted S. 1362 authored by Senator 
Carper and me. Our legislation gave the Department authority to develop 
pilot programs for extending the PACE model to new populations so 
additional frail individuals can live in the comfort of their home and 
receive the care they need instead of having to be transferred to a 
nursing home setting. How is the administration proceeding in the 
development of those pilots and when can we expect CMS to announce the 
opportunity to participate in a pilot?

    Answer. First, I would like to thank you and Senator Carper for 
your leadership on this issue. The recently enacted PACE Innovation Act 
of 2015 expands the Department's authority to allow waivers in order to 
conduct demonstration projects that involve PACE. We are excited about 
these new opportunities, and CMS is developing options for moving 
forward.

    The 2016 President's budget includes a legislative proposal to 
create a pilot demonstration to test whether the PACE program can 
effectively serve a younger (55 and under) population without 
increasing costs. This proposal was removed from the 2017 President's 
budget because your recently passed legislation grants HHS the 
authority to test this expansion and other PACE models under the CMS 
Innovation Center authority.

    CMS is actively working with stakeholder and advocacy groups to 
determine how the PACE comprehensive care approach can be combined with 
community care models and expanded to reach a broader population. We 
will keep your staff informed as this work proceeds.
                         fda opioid er/la rems
    Question. The FDA has an Extended Release/Long-Acting Opioid Risk 
Evaluation and Mitigation Strategy. In implementing the REMS, FDA set a 
goal of having one-quarter of 320,000 prescribers being trained under 
the medical education requirements of the REMS by March 2015. Within 4 
years' time, 60% of prescribers were to be trained. Did FDA hit its 
goal for March 2015, and how many prescribers have completed the 
training today?

    Answer. We are making significant strides in our efforts to reduce 
opioid dependence, overdose, and death, but more needs to be done. The 
President's FY17 budget continues to expand the fight against opioid 
abuse, misuse, and overdose with significant investments in 
interventions that will make the most impact. The budget includes a $10 
million increase, for a total of $77 million, 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 DC through the Prescription Drug Overdose Prevention to States 
program, as well as $5 million to harmonize technical standards in 
support of Prescription Drug Monitoring Programs, improve clinical 
decision-making, and further the adoption of electronic prescribing of 
controlled substances.

    Regarding your specific question, as of February 28, 2015 the 
number of ER/LA opioid analgesic prescribers trained at this milestone 
was 37,512, which is slightly less than half the 80,000 prescriber 
training goal with 2 years. FDA subsequently received updated 
information on these numbers, which shows a total of 38,370 ER/LA 
prescribers trained as of May 28, 2015. Of note, over 100,000 
healthcare professionals completed the CE training; but cannot be 
counted towards the training goal due to either not prescribing an ER/
LA opioid analgesic in the past 12 months or not being DEA registered.

    We intend to share these results with a joint public meeting of the 
Drug Safety and Risk Management Advisory Committee and the Anesthetic 
and Analgesic Drug Products Advisory Committee to assess its impact on 
preventing the misuse and abuse of opioids. The agency will training 
and expansion of the REMS program to include immediate-release opioids. 
For more information on the upcoming advisory committee meeting, please 
see the Federal Register notice at: https://federalregister.gov/a/2016-
05573.
                                 gdufa
    Question. Until enactment of the Generic Drug User Fee Act, FDA's 
facilities database lacked accurate information on facilities involved 
in the manufacture of drugs. Today, over 4,220 facilities supporting 
generic drug applications have annually self-identified improving FDA's 
visibility into the global drug supply chain. As a result we know that 
China is now the world's largest supplier of Active Pharmaceutical 
Ingredients (API) and also has the largest number of foreign, FDA-
registered drug manufacturing facilities, about 700, followed by India.

    Of over 4,000 facilities registered through GDUFA program, how many 
have been inspected within last 3 years?

    Answer. Ensuring safety in these facilities is a priority for the 
FDA. The chart below is the total number of all human drug inspections, 
both domestic and foreign (excludes State Contract and State 
Partnership Inspections), conducted by FDA investigators for Fiscal 
Years 2013-2015:


                                          FDA Human Drug Inspections *
----------------------------------------------------------------------------------------------------------------
           Fiscal Year (FY)                     Domestic Inspections                 Foreign Inspections
----------------------------------------------------------------------------------------------------------------
FY 2013                                                              1,851                                  827
FY 2014                                                              1,869                                  993
FY 2015                                                              1,775                                1,072
----------------------------------------------------------------------------------------------------------------
* This data was generated on 12/10/2015 and excludes State Contract and State Partnership Inspections.
NOTE: The ORA database for drug inspection counts is not coded to separate out GDUFA inspections from other drug
  firm inspections.


    Question. More than 900 new employees in the office of Generic 
Drugs have been hired since GDUFA began. Of these new hires, how many 
inspectors are assigned to foreign and domestic drug manufacturing 
facilities?

    Answer. Field investigators are actually within the Office of 
Regulatory Affairs (ORA) rather than the Office of Generic Drugs (OGD). 
One-hundred forty people have been hired in ORA under the Generic Drug 
User Fee Act (GDUFA) from 2013-2015 with 80 hired as field 
investigators to perform both foreign and domestic drug inspections.

                                 ______
                                 
                Questions Submitted by Hon. Pat Roberts
    Question. In 2011, the president issued an Executive Order 
directing each agency to periodically review its existing significant 
regulations to determine whether any such regulations should be 
modified, streamlined, expanded, or repealed so as to make the agency's 
regulatory program more effective or less burdensome. During these 
reviews, what were some of the regulations that, according to public 
comments, were most burdensome?

    Answer. The Department of Health and Human Services has made 
significant progress in its retrospective review activities since 
President Obama's January 2011 Executive Order 13563 on Improving 
Regulation and Regulatory Review. In the Executive Order, the President 
recognized the importance of a streamlined, effective, efficient 
regulatory framework to achieve economic growth, increased investment, 
job creation, and competition. HHS is committed to identifying and 
reviewing existing regulations in order to eliminate those that are 
obsolete, unnecessary, burdensome, or counterproductive or to modify 
others to increase their effectiveness, efficiency, and flexibility.

    The Executive Order calls not for a single exercise, but for 
``periodic review of existing significant regulations,'' with close 
reference to empirical evidence. It explicitly states that 
``retrospective analyses, including supporting data, should be released 
online wherever possible.'' Consistent with the commitment to periodic 
review and to public participation, HHS continues to assess its 
existing significant regulations. Since the President's Executive Order 
on Improving Regulation and Regulatory Review, HHS has made significant 
progress in its retrospective review activities.

    Since January 2012, HHS has posted biannual progress updates on its 
retrospective review initiatives; for instance, in the July 2014 
update, HHS highlighted the completion of a series of rules from the 
Centers for Medicare and Medicaid Services (CMS) to reform existing 
regulations to reduce unnecessary costs and increase flexibility for 
health care providers. This final rule reduced the burden of outmoded 
Medicare rules concerning numerous daily practices in hospitals, 
thereby increasing the ability of health care entities to focus 
resources on providing high-quality patient care.

    It is estimated that the overall national cost savings created by 
this rule is between approximately $230 million to $830 million per 
year annualized before 2019. Additionally, HHS invites the public to 
suggest additional items for retrospective review (for reasons 
including regulatory burden) at www.hhs.gov/retrospectivereview.

    Question. In 2014, a CMS spokesperson said that regarding the 
Affordable Care Act's risk corridor's program, ``the policy, modeled on 
the risk corridor provision in Part D was estimated to be budget 
neutral, and we intend to implement it as designed.'' However, since 
then, HHS has said that they will ``explore other sources of funding 
for risk corridors payments.'' Given the shortfall of about $2.5 
billion shortfall for 2014, what ``other sources of funding'' was this 
statement referring to or is HHS considering?

    Answer. As noted in previous guidance, additional risk corridors 
payments for program year 2014 will be paid out of 2015 risk corridors 
collections, and if necessary, 2016 collections. Since this is a 3 year 
program, we will not know how collections compare to payments for the 
program until the end of FY 2017, when the data from all 3 years of the 
program can be analyzed and verified. In the event of a shortfall over 
the life of the 3-year Risk Corridors program, the agency will work 
with Congress to provide necessary funds for outstanding payment.

    Question. HHS's National Vaccine Program Office (NVPO) recently 
finalized the National Adult Immunization Plan (NAIP). What steps does 
your department plan to take in the short-term and long-term to advance 
and monitor progress in NAIP implementation through both Federal and 
non-Federal stakeholders?

    Answer. The National Adult Immunization Plan (NAIP) is a 5-year 
strategic plan developed through the HHS National Vaccine Program 
Office (NVPO) to address the goals of (1) strengthening the adult 
immunization infrastructure; (2) improving access to adult vaccines; 
(3) increasing community demand for adult immunizations; and (4) 
fostering innovation in adult vaccine development and vaccination-
related technologies. As a national plan, it will require engagement 
from a wide range of Federal and non-Federal stakeholders to achieve 
these goals. The plan emphasizes collaboration and prioritization of 
efforts that will have the greatest impact. The NAIP is intended to 
facilitate coordinated action by Federal and non-Federal partners to 
protect public health through vaccination of adults, and includes 
indicators to draw attention to and track progress against core goals, 
such as adult vaccination coverage and percentage of adults over 18 who 
are vaccinated against various diseases.

    In developing the Plan, NVPO sought input from the adult 
immunization community, particularly regarding their role in reaching 
the Plan's goals and objectives. Looking forward, NVPO is developing an 
accompanying implementation plan, planned for release in 2017. This 
implementation plan will outline a set of concrete actions that can be 
taken by different stakeholders to support plan objectives and goals.

    NVPO, in partnership with other Federal agencies, will regularly 
track and annually summarize progress on achieving the goals and 
indicators in the NAIP and present them to the Assistant Secretary for 
Health and to the National Vaccine Advisory Committee, which recommends 
ways to prevent infectious diseases through vaccine development and 
provides direction to prevent any adverse reactions to vaccines, in an 
effort to highlight the impact of NAIP implementation activities, as 
well as to identify any areas where progress is lagging and propose 
corrective action where needed.

    Question. Please describe CMS's approach to adverse event tracking 
for biosimilars in both Part B and Part D. Are PBMs and insurers 
capable of tracking product-specific biosimilar adverse events in Part 
B given the current code modifier process proposed by CMS?

    Answer. Patient safety is a top priority at HHS. In the final CMS 
rule finalizing Part B payment policy on biosimilars issued late last 
year, CMS addressed concerns about the need to track the particular 
biosimilar a beneficiary receives. CMS noted that it was developing an 
approach for using manufacturer-specific modifiers on claims to assist 
with pharmacovigilance, and would be providing guidance on mechanisms 
for tracking drug use through claims information in the near future. 
Since the publication of the final rule, CMS has implemented a 
requirement that claims for biosimilars must include a modifier that 
identifies the manufacturer of the specific product and has published 
guidance on the use of the modifier. Each biosimilar, as CMS begins to 
pay for it, will be assigned a unique modifier to identify that 
particular biosimilar. This unique HCPCS-modifier combination allows 
the tracking of exactly which biosimilar a beneficiary receives. PBMs, 
insurers, the FDA and other bodies interested in pharmacovigilance will 
be able to identify the biosimilar each beneficiary received.

    Question. CMS recently announced its intent to test new payment 
methods for Medicare Part B drugs through CMMI. What additional payment 
changes is CMS considering beyond modifications to the ASP 
reimbursement rate? Will these payment methods go through regular 
notice and comment rulemaking, and what is the timeline for beginning 
this demonstration? How will CMS select the drugs to which these 
additional payment modifications will apply?

    Answer. We are examining potential ways to support increased access 
to information, drive innovation, and strengthen incentives to improve 
quality care. We continue to look at a number of options in this area.

    Last fall, HHS convened a forum that brought together consumers, 
providers, employers, manufacturers, health insurance companies, 
representatives from State and Federal government, and other 
stakeholders to discuss ideas on how our country can meet the dual 
imperatives of encouraging drug development and innovation while 
protecting access and affordability. We came away with feedback to 
address these challenges in a holistic fashion addressing three 
important areas: (1) increasing access to information to support better 
health care decisions, (2) driving innovation that improve and save 
lives, (3) and strengthening incentives in the delivery system to 
reward quality care to patients and encourage value-based and outcomes-
based decision making.

    Coming out of that forum, we have identified several areas of 
potential opportunity for consideration and collaborative policy 
development. The need for better information about drug prices and 
impacts on patients and providers in making better health care 
decisions was one theme that we heard across multiple panels. To that 
end, in December, we took a first step forward by providing more 
detailed information on Medicare spending on prescription drugs, for 
both Part B (primarily drugs administered in doctors' offices and other 
hospital outpatient settings) and Part D (primarily drugs patients take 
themselves) to better inform decision making. The Medicare Drug 
Spending Dashboard provides important information to the public in an 
accessible format, and also serves as a first step to provide other 
information that can enrich the picture.\8\
---------------------------------------------------------------------------
    \8\ All responses are accurate as of February 11, 2016.

                                 ______
                                 
              Questions Submitted by Hon. Michael B. Enzi
    Question. Please detail what the Department of Health and Human 
Services' plan and steps for implementing the recommendations made by 
the Government Accountability Office (GAO) in their report published 
February 23, 2016. It should be concerning to every taxpayer that the 
undercover work done by GAO went forward with largely no check by the 
Department.

    In the GAO report, they highlighted eight recommendations. The 
Department has agreed that those changes should be made. You provided 
comments on those recommendations to GAO, please outline what process 
will be put in place to effect those changes.

    In your response please include the Department's understanding of 
the problem, what policies will be changed to address the problems, 
what kind of action plan will be put in place, what kind of steps will 
need to be taken by the agency--including any changes in guidance or 
rulemaking, what other entities or sectors will be impacted by these 
changes, and a timeline for when the problems will be solved.

    Answer. We look forward to receiving the final report and 
recommendations from GAO and take seriously our responsibility to 
implement these findings. As with all GAO reports, we will continue to 
work with the GAO to improve HHS programming.\9\
---------------------------------------------------------------------------
    \9\ All responses are accurate as of February 11, 2016.

    Question. GAO found an opportunity to reduce duplication and 
achieve greater results in their ``2015 Annual Report: Additional 
Opportunities to Reduce Fragmentation, Overlap, and Duplication and 
Achieve Other Financial Benefits,'' making the following 
---------------------------------------------------------------------------
recommendation:

        Please help ensure that the eight Federal agencies 
        administering over 100 programs supporting individuals with 
        serious mental illness are able to develop an overarching 
        perspective in order to understand the breadth of programs and 
        resources used--including any potential gaps or overlap--
        greater coordination of Federal efforts is needed from the 
        Department of Health and Human Services, and within it, the 
        Substance Abuse and Mental Health Services administration, 
        which is required to promote coordination of programs relating 
        to mental illness throughout the Federal Government.

    Please detail what HHS currently does to coordinate this work and 
what steps, if any, are being considered to improve that work? Please 
include any gaps that the Department has identified, any areas that 
require additional authority to take coordinating action, and what 
formal or informal processes are in place to work with other agencies.

    Answer. HHS has been working to build upon and expand intra- and 
inter-agency Federal coordination efforts related to individuals with 
serious mental illness (SMI). The primary mechanism for intra-agency 
coordination is the Behavioral Health Coordinating Council's (BHCC) 
Subcommittee on Serious Mental Illness, which is comprised of 22 
members and 24 contributors from more than 15 Federal offices and 
agencies, including Substance Abuse and Mental Health Services 
Administration (SAMHSA); National Institutes for Health (NIH), 
including the National Institute for Mental Health (NIMH), the National 
Institute on Drug Abuse (NIDA), and the National Institute on Alcohol 
Abuse and Alcoholism (NIAAA); Assistant Secretary for Planning and 
Evaluation (ASPE); Assistant Secretary for Community Living (ACL); 
Health Resources and Services Administration (HRSA); Agency for Health 
Care Research and Quality (AHRQ); Assistant Secretary for Financial 
Resources (ASFR); Centers for Medicare and Medicaid Services (CMS); 
Food and Drug Administration (FDA); Centers for Disease Control and 
Prevention (CDC); Office of Civil Rights (OCR); Office of the National 
Coordinator (ONC); and Office of the Assistant Secretary for Health 
(OASH).

    In 2015, the Subcommittee produced a comprehensive compilation of 
Federal programs that specifically target and/or support individuals 
with SMI. In support of its overall mission, the SMI Subcommittee has 
established the Secretarial Initiative on SMI to address the needs of 
Americans living with SMI. The aim of this initiative and the HHS 
Action Plan will center on improving outcomes for people with SMI and 
support for their families. HHS prioritizes action in three areas 
reducing the duration of untreated SMI in individuals through early 
engagement in care soon after these conditions arise; improving the 
quality of care through stronger measurement and accountability; and 
increasing access to evidence-based and community-based treatment and 
support services. These Priorities are reflected in the President's 
budget proposal.

    SAMHSA continues to advance the three priority SMI priority areas 
(Early Engagement in Care, Increased Quality of Care, and Availability 
of Community Based Supports), as well as other priority behavioral 
health issues, through its leadership of several other Federal efforts, 
including:

          Working closely with the U.S. Interagency Council on 
        Homelessness (USICH), which I currently chair, and the 
        Departments of Housing and Urban Development (HUD) and Veterans 
        Affairs (VA) to implement the Federal strategic plan to prevent 
        and end homelessness called ``Opening Doors.''
          Expanding the Behavioral Health Treatment Court 
        Collaborative working with the Department of Justice, courts, 
        and criminal justice agencies to enable more courts and 
        providers to collaborate on supporting individuals with SMI in 
        their communities.
          Continuing to collaborate with the Departments of Education 
        and Labor, and States on supported employment grants that 
        enhance a State's ability to sustain and bring to scale the use 
        of evidence-based supported employment programs for adults with 
        SMI.
          Leading, in partnership with many Federal departments such 
        as the Department of Defense, Veterans Affairs, Interior, and 
        HHS agencies such as the CDC, ACL, Indian Health Service (IHS), 
        and the Office of the Surgeon General, the National Strategy 
        for Suicide Prevention and the National Action Alliance for 
        Suicide Prevention to reduce the number of suicides. Continuing 
        to promote supportive housing services through Projects for 
        Assistance in Transition from Homelessness (PATH) collaborating 
        with HUD.

                                 ______
                                 
                Questions Submitted by Hon. Rob Portman
                          cmmi demonstrations
    Question. Last fall, CMS's Center for Medicare and Medicaid 
Innovation (CMMI) released two model test announcements related to 
Medicare Advantage and Part D to be implemented in 2017. The first 
relates to testing value-based insurance design (VBID) and the second 
relates to testing enhanced medication therapy management (MTM) 
strategies. As I understand it, applications for both demonstrations 
were due to CMMI last month. How many plan sponsors applied to 
participate in each demonstration? How many applications do you 
anticipate will be approved for each demonstration? What is CMMI doing 
to ensure that the operation of these demonstrations are aligned with 
the regular preparations for the 2017 bid cycle and plan year?

    Answer. As part of the Health Plan Innovation Initiatives, in 2015, 
CMS announced two models that will test different innovations in 
Medicare health and prescription drug plans, and the impact they have 
on improving health outcomes and lowering expenditures for plan 
enrollees. As you know, applications for the Medicare Advantage VBID 
model were due in November 2015, and applications for the Part D 
Enhanced MTM model were due in January 2016. CMS is currently 
evaluating applications received.

    The model timelines were established to align with the annual bid 
cycle process in Parts C and D and information related to these models 
will be included in the 2017 Call Letter.
                                 samhsa
    Question. SAMHSA administers the Now is the Time Project AWARE 
program which gives out grants to Local Educational Agencies (LEAs) to 
support training of school personnel to detect and respond to mental 
illness in our youth. However, these Federal dollars have been 
interpreted to narrowly only apply to one specific type of mental 
health awareness program, in lieu of other ones listed in their 
National Registry of Evidence-Based Programs and Practices (NREPP). In 
December, the Mental Health Awareness and Improvement Act, passed the 
Senate by unanimous consent. In this bill, we reauthorized mental 
health awareness training programs that will help train our country's 
educators to recognize and understand mental illness and we did so in a 
way that allows States to choose the type of training programs that 
will best suit the needs of their schools and communities. Can you 
state the reasons why SAMHSA currently restricts the eligibility for 
Project AWARE dollars to only one program administered by one 
organization in lieu of others listed in their Registry? Do you believe 
State and local agencies should be able to choose the evidence-based 
and proven program that works best for their school and community?

    Answer. Mental health is a priority that we share with you and your 
colleagues in Congress. As part of SAMHSA's overall efforts to improve 
the behavioral health awareness among school-age youth and their 
communities, SAMHSA administers three Project AWARE grant programs: one 
at the local level as you note, one at the State level, and another at 
a broader community level.

    As you know, the Project AWARE program expands the capacity of 
State and local education agencies to increase awareness of mental 
health issues, train school personnel and other adults, and connect 
children and families who may experience behavioral health issues with 
appropriate services.

    SAMHSA has implemented Project AWARE following Congress's 
direction. To provide appropriate flexibility within the Mental Health 
First Aid program, grantees at the State level are able to use funds to 
support implementation of a range of other evidence-based programs to 
improve student behavioral health according to the needs of their State 
and communities. In general, language in SAMHSA's Mental Health First 
Aid funding opportunity announcement is designed to give grantees 
flexibility to choose the practices that meet the goals of the grant 
program and meet the unique needs of the grantee in question.
                           medicare advantage
    Question. The President's budget calls for $77 billion in cuts to 
the Medicare Advantage program by establishing a competitive bidding 
program. After years of rate reductions and changes to the payment 
system, further cuts to the program will create more uncertainty at a 
time when beneficiaries need stability in Medicare Advantage. How will 
CMS ensure that competitive bidding will not jeopardize beneficiary 
choice of and access to health plans, or the current availability and 
generosity of supplemental benefits?

    Answer. Medicare Advantage represents a growing part of the 
Medicare program with more than a third of all Medicare beneficiaries 
enrolled in a Medicare Advantage plan. If recent growth in the program 
continues, a majority of Medicare beneficiaries could be enrolled in 
Medicare Advantage by 2030. According to MedPAC analysis, net program 
spending by MA plans is approximately 2 percent above spending for fee-
for-service, on average. Paying more for Medicare Advantage is not 
sustainable--for beneficiaries or taxpayers. As the proportion of 
Medicare beneficiaries who are enrolled in Medicare Advantage 
increases, the current financing model for the Medicare Advantage 
program that overpays relative to fee-for-service threatens the long-
term fiscal sustainability of the overall Medicare program.

    While the average Medicare Advantage plan margin per beneficiary 
may decrease under the proposal, projected increases in enrollment will 
continue to make Medicare Advantage attractive for private plans. This 
proposal would also reduce the rate of growth in overall Medicare 
spending, resulting in lower growth in Part B premiums for all 
beneficiaries. Additionally, the budget proposal is structured so that 
the majority of beneficiaries will maintain access to supplemental 
benefits and will allow higher quality plans to provide more 
supplemental benefits if they bid at the same rate as lower quality 
competitors. Implementing competitive bidding in the Medicare Advantage 
program would reduce the rate of growth in Medicare Advantage payments 
and premiums, contributing to a sustainable program over the long term.
            implementation of complex rehab technology delay
    Question. At the end of 2015, I worked with my colleague Senator 
Casey to pass S. 2425, the ``Patient Access and Medicare Protection Act 
(PAMPA).'' The bill included a provision that directed CMS from 
applying the competitive bidding pricing structure to complex 
rehabilitative equipment until 2017 and instead allow individuals who 
rely on complex rehabilitative equipment to maintain access to these 
products. However, on January 22, 2016 CMS announced that it cannot 
implement section 2 of the ``Patient Access and Medicare Protection Act 
(PAMPA)'' until July 1, 2016. I am very concerned with the impact this 
will have on providers and beneficiaries who rely on these complex 
rehab accessories. Paying at the reduced amount for 6 months of the 12 
month delay creates the same financial hardship that would be in place 
without the delay.

    I understand that CMS performs regular updates to its software and 
systems. While I understand that this bill was not signed into law 
until December 28, 2015, I know when Congress has approved last minute 
delays in the past CMS has been able to prioritize revised updates and 
guarantee that providers were paid appropriately.

          Can you explain why it will take CMS over 6 months to 
        implement this provision?

          This access issue for people with disabilities was 
        identified by Congress and communicated to CMS in early 2015. I 
        joined 25 other Senators and 101 House members in a letter to 
        CMS highlighting the need for a ``fix'' of this issue early in 
        2015. CMS's refusal to accept the recommendation in the 
        congressional letters necessitated the passage of this 
        legislation. Was CMS unaware of Congress's concerns of this 
        issue?

    Answer. We are aware of and appreciate your concerns regarding this 
issue. CMS began working on implementation of the Patient Access and 
Medicare Protection Act of 2015 (PAMPA) when it first passed Congress 
in late December. Since PAMPA was signed into law at the end of 
December, it would not have been feasible for us to implement it on 
January 1, 2016. Given the amount of system changes required and the 
testing involved, the soonest we are able to implement this change is 
July 1, 2016. Until these changes are implemented, payments for these 
items will be based on the adjusted Durable Medical Equipment (DME) fee 
schedule amounts. The DME adjusted fee schedule rates are currently in 
a 50/50 blend during this six month transition period. The average 
reductions for these Group 3 complex rehabilitative wheelchair 
accessories are about 10 percent. On or after July 1, 2016, suppliers 
can adjust previously paid claims to receive the full fee schedule 
amount.

    To ensure beneficiary access to these accessories particularly for 
vulnerable populations, CMS recently posted on DME Spotlight web page 
of their website that advance payment may be available for suppliers. 
According to our regulations, an advance payment means a conditional 
partial payment made by the contractor in response to a claim that is 
unable to process within established time limits. Suppliers are able to 
submit a single advance payment request to their Medicare 
Administrative Contractor for multiple claims during this period. These 
advance payments may be issued if certain regulatory requirements are 
met.

    CMS will be monitoring beneficiary access closely during this time 
to ensure that beneficiaries receive the wheelchairs and accessories 
that they need.
            workers compensation medicare set-aside program
    Question. The Workers Compensation Medicare Set-Aside (WCMSA) 
program requires the Centers for Medicare and Medicaid Services (CMS) 
to review workers' compensation settlements submitted to CMS to 
determine Medicare's interest in future medical amounts that may have 
been included in workers' compensation settlements involving Medicare 
beneficiaries.

    As a sponsor of S. 1514, the Medicare Secondary Payer and Workers' 
Compensation Settlement Agreements Act, I look forward to working with 
you to improve the CMS process of reviewing Workers' Compensation Set-
aside Arrangements and establishing a clear, predictable, and efficient 
system. S. 1514 also includes a provision that would authorize payment 
of amounts for future medical in workers' compensation settlements to 
be paid directly to meet Medicare Secondary Payer (MSP) future medical 
obligations.

    The administration's Fiscal Year (FY) 2017 budget request includes 
a provision under which CMS would be authorized to accept lump sum 
certain payments to satisfy MSP obligations. The language specifically 
provides:

        Allow Beneficiaries to Pay a Sum Certain to Medicare for Future 
        Medical Items and Services Medicare beneficiaries are unable to 
        satisfy Medicare Secondary Payer ``Future Medical'' obligations 
        at the time of settlement, judgment, award, or other payment 
        because the current law does not specifically permit the 
        Secretary to deposit such payment in the Medicare Trust Funds. 
        Future Medical is defined as Medicare covered and otherwise 
        reimbursable items and/or services furnished after the date of 
        settlement, judgment, award, or other payment. This proposal 
        expands current Medicare Secondary Payer statutory authority to 
        permit the Secretary to deposit into the Medicare Trust Funds a 
        lump sum, upfront payment from beneficiaries when they obtain 
        liability insurance, no-fault insurance, and workers' 
        compensation settlements, judgments, awards, or other payments. 
        [$65 million in savings over 10 years]

    Will your office work with me to review data and assumptions and 
determine the savings that can be identified through direct payment 
options, including those proposed in S. 1514?

    Answer. We are happy to provide technical assistance on the 
legislation you mentioned.

    Currently, individuals involved in certain workers' compensation 
situations are able to use Medicare's formal, yet voluntary, Medicare 
Set-Aside Arrangement (MSA) review process in order to determine if a 
proposed set-aside amount is sufficient to meet their MSP obligations 
related to ``future medicals.'' Medicare beneficiaries are currently 
unable to satisfy their Medicare Secondary Payer Future Medicals 
obligations at the time of settlement, judgment, award, or other 
payment. Beneficiaries and their legal representatives have requested 
the opportunity to resolve a beneficiary's Medicare Secondary Payer 
obligation with respect to Future Medicals by paying a lump sum to 
Medicare, perhaps at a time close to or contemporaneous with the 
settlement, judgment, award, or other payment at issue.

    As you noted, the President's FY 2017 Budget request includes a 
proposal to expand current Medicare Secondary Payer statutory authority 
to permit the Secretary to deposit into the Medicare Trust Funds a lump 
sum, upfront payment from beneficiaries when they obtain liability 
insurance, no-fault insurance, and workers' compensation settlements, 
judgments, awards, or other payments. This would benefit the 
beneficiary as he/she would have no need to track and administer the 
funds at issue, thereby avoiding administrative costs for the 
beneficiary as well as the Medicare program.

                                 ______
                                 
                 Questions Submitted by Hon. Tim Scott
    Question. In response to my question about the solvency of State 
healthcare CO-OPs, you mentioned that HHS has sought to provide clarity 
in guidance issued to State directors. Could you expand on that and 
provide my office with the guidance you've issued? Have you gotten 
feedback on said guidance from the State directors?

    Answer. On January 27, 2016 CMS issued additional guidance through 
Frequently Asked Questions (FAQs) about the CO-OP program.\10\
---------------------------------------------------------------------------
    \10\ https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/
Downloads/CO-OP-Questions-Final-1-27-16.pdf.

    Question. Furthermore, when considering the future solvency of the 
CO-OPs, what steps is CMS taking to ensure stakeholders are made whole 
and consumers held harmless from costs incurred by the failed CO-OPs? 
What is the impact of the CO-OP closures on the wider market including 
---------------------------------------------------------------------------
insurers, providers, and agents/brokers?

    Answer. The primary focus of all our efforts is to ensure that CO-
OPs and other Marketplace plans are meeting the needs of their 
consumers and building for a successful future. Each of the consumers 
in the CO-OPs that closed at the end of 2015 maintained coverage until 
the end of the year, and nearly three-quarters \11\ of the CO-OP 
Marketplace consumers have continued their coverage in a new plan in 
2016. Affected CO-OP enrollees had access to a special enrollment 
period, and are able to shop for 2016 coverage on the Marketplace until 
February 28, 2016. In all cases, CMS is focused on making sure 
consumers continue to receive medical services.
---------------------------------------------------------------------------
    \11\ Does not include consumers who enrolled in new plans outside 
the Marketplace.

    The CO-OP program is only one part of the Affordable Care Act's 
overall approach to encourage competition and to give consumers a 
variety of affordable coverage choices. Whether consumers are getting 
coverage from a CO-OP, another issuer, or Medicaid, millions of 
Americans who were previously uninsured now have access to affordable, 
high quality health care coverage. As several of the Affordable Care 
Act's coverage provisions took effect, an estimated 20 million 
Americans gained coverage. In the years since the passage of the 
Affordable Care Act, we have seen increased competition among health 
plans and more choices for consumers.\12\ During the third Marketplace 
Open Enrollment, 9 out of 10 returning customers were able to choose 
from 3 or more issuers for 2016 coverage, up from 7 in 10 in 2014.\13\
---------------------------------------------------------------------------
    \12\ www.hhs.gov/about/news/2015/07/30/competition-and-choice-in-
the-health-insurance-marketplace-lowered-premiums-in-2015.html.
    \13\ www.hhs.gov/about/news/2015/07/30/competition-and-choice-in-
the-health-insurance-marketplace-lowered-premiums-in-2015.html.

    Question. States have been told there are sufficient funds in the 
temporary Reinsurance program to pay all reinsurance money owed to 
individual market issuers. For CO-OPs that are in a receivership but 
that have made all required payments to be eligible to participate in 
the reinsurance program, is the Federal Government considering 
offsetting amounts owed to CO-OPs through the Reinsurance program by 
---------------------------------------------------------------------------
payments owed by CO-OPs for their solvency/startup loans?

    Answer. We take our obligation to taxpayers very seriously. The 
U.S. Department of Justice is responsible for collecting any debts owed 
the U.S. Government. While it is too early to tell how much money can 
be recovered, we are working in close collaboration with the Department 
of Justice and will use all available tools to recover money from these 
companies.

    Question. If CMS intends to set off any amounts owed to failed CO-
OPs to recoup the amounts provided under the loan agreements, this set-
off will likely mean that State insurance directors will need to 
utilize guaranty associations (where available) to help pay providers 
for covered claims. Is CMS aware that it would then ultimately be 
recouping these funds from the taxpayers of the States in which these 
programs were operating? Do you believe that to be fair to taxpayers?

    South Carolina law provides for a guaranty association. The South 
Carolina Life and Accident and Health Insurance Guaranty Association 
will help pay some covered claims for South Carolina members and 
providers up to the limits provided under South Carolina law. What will 
happen to the providers and members with CO-OP claims in States where 
there is no guaranty fund protection? How will those CO-OP members be 
protected? How are States with no guaranty funds supposed to protect 
their citizens from this failed experiment?

    Answer. As the primary regulators of insurance, States have their 
own laws that govern the orderly wind-down of any insurance company 
that goes out of business in their State. During closeout, most CO-OPs 
exiting the market were placed into a receivership or supervisory 
status that controls assets, expenses, and contractual rights and 
obligations including ongoing operating costs and claims payment. These 
arrangements protect remaining funds. As you mentioned, the 
availability of guaranty funds does impact the run-out of outstanding 
claims. CO-OP wind-downs are treated like the wind-downs of other 
health insurers and are overseen by State Departments of Insurance. 
Each State determines whether insurers participate in a guaranty 
association and HHS has no role in that decision.

    Question. I understand that the purpose of the enrollment periods 
in Obamacare are to enroll people on a consistent basis and prevent 
those who would enroll immediately before they would actually need to 
use insurance. The latter scenario seems to place a significant cost 
burden on private insurers participating in the exchanges. At the same 
time, it seems that, in a way, HHS is essentially undercutting the 
purpose of the enrollment periods by allowing ``special enrollment 
periods'' for a wide variety of purposes, some of which may not be 
related to someone's health condition. These special enrollment periods 
seem to again, place a lot of costs on the private insurers in the 
exchanges, and therefore make the exchanges much less sustainable and 
attractive for private insurers. How do we create consistency in 
enrollment so that the exchanges may be more attractive to private 
insurers?

    Answer. Special enrollment periods (SEPs) are one way to make sure 
that people who lose health insurance during the year or who experience 
major life changes like getting married have the opportunity to enroll 
in coverage outside of the annual Open Enrollment period. SEPs are a 
longstanding feature of employer insurance. We are committed to making 
sure that SEPs are available to those who qualify for them, while also 
putting in place measures to protect SEP program integrity.

    We continue to review the rules around SEPs in order to keep them 
fair for issuers and for consumers. We have announced several changes 
including:

          Clarifying language to make the rules of the road are clear 
        to everyone,
          Reviewing all SEPs and eliminating those that are no longer 
        necessary, such as:
              Consumers who enrolled with too much in advance 
        payments of the premium tax credit because of a redundant or 
        duplicate policy;
              Consumers who were affected by an error in the 
        treatment of Social Security Income for tax dependents;
              Lawfully present non-citizens that were affected by 
        a system error in determination of their advance payments of 
        the premium tax credit;
              Lawfully present non-citizens with incomes below 
        100% FPL who experienced certain processing delays;
              Consumers who were eligible for or enrolled in COBRA 
        and not sufficiently informed about their coverage options;
              Consumers who were previously enrolled in the Pre-
        Existing Condition Health Insurance Program; and providing 
        stronger enforcement so that special enrollment periods serve 
        the purpose for which they are intended and do not provide 
        unintended loopholes.

    We will continue to monitor how special enrollment periods are used 
and we anticipate that we may make changes in the future.

    Question. As you know, the President has proposed additional--and 
costly--incentives for the remaining States to expand Medicaid. This is 
in addition to the Medicaid expansion we have already seen under the 
ACA. Because of this rapid growth, the quality of care that the program 
is able to offer has diminished greatly. For example, even once they 
have coverage, it continues to be difficult for Medicaid beneficiaries 
to find a doctor that participates, particularly in underserved areas 
without lots of physicians to choose from. The system is overburdened. 
Given this, do you still think that Medicaid expansion, and the 
President's request for additional incentives for further expansion, 
are responsible or in the best interest of millions of Americans?

    Answer. For five decades, Medicaid has helped facilitate access to 
needed health services and provided financial security through 
protection from high out-of-pocket costs for millions of low-income 
Americans. We continue to see Democratic and Republican governors and 
bipartisan coalitions across the country working hard to expand. We 
know that Medicaid has played an important role in providing 
comprehensive care for children that helps support their growth, school 
readiness, and development. Medicaid has also supported working 
families whose employers do not offer affordable health insurance, and 
fostered better health for pregnant women and positive birth outcomes 
for their babies by facilitating access to critical prenatal services. 
It has helped address the frequently complex health needs of people 
with disabilities, and supported them in living independently. And it 
has covered long-term care services and supports for millions of 
America's seniors and works in concert with Medicare to meet critical 
health needs.

    You raise financial incentives for States, and your concerns around 
cost. Studies show that Medicaid expansion is a net positive for State 
budgets, even after the Federal match falls below 100 percent.\14\ 
Medicaid expansion brings additional Federal resources into State 
economies, which creates jobs and supports economic growth, ultimately 
improving State budgets. In Kentucky, expansion is projected to add 
40,000 jobs and $30 billion to the State economy through 2021. 
Expansion reduces the uncompensated care burden on States' health care 
providers. In 2014, uncompensated care was reduced by $7.4 billion, 
compared to what it would have been had coverage remained at 2013 
levels.
---------------------------------------------------------------------------
    \14\ http://kff.org/report-section/the-effects-of-the-medicaid-
expansion-on-state-budgets-an-early-look-in-select-states-appendix-d/.

    Importantly, expansion increases access to needed care. A recent 
Health Affairs study comparing two States that expanded Medicaid to one 
that did not found that the expansion States saw an increase in 
residents with chronic conditions getting regular medical care, and a 
decrease in residents skipping medications because of cost or having 
trouble paying medical bills.\15\
---------------------------------------------------------------------------
    \15\ http://www.commonwealthfund.org/publications/issue-briefs/
2015/jun/does-medicaid-make-a-difference.

    Multiple surveys show that Medicaid beneficiaries are satisfied 
with their coverage. According to a survey by Kaiser, two-thirds of 
those currently covered by Medicaid (65 percent) report that it is 
working well for most low-income people covered by the program. With 
respect to the concern you raise regarding providers, most providers 
accept Medicaid patients. According to the National Center for Health 
Statistics 93 percent of primary care physicians accept Medicaid and 72 
percent of physicians accept new patients. Those numbers are similar to 
---------------------------------------------------------------------------
the private insurance industry.

                                 ______
                                 
                Question Submitted by Hon. Richard Burr
    Question. It is important that the regulations implementing the 
Protecting Access to Medicare Act (PAMA) are consistent with the 
Clinical Laboratory Fee Schedule reforms envisioned by Congress. PAMA 
required the outdated payment methodology to be replaced with a process 
in which Medicare reimbursement rates will be determined based on the 
reporting of private market rates by clinical laboratories. These 
changes should be implemented in a manner consistent with congressional 
intent to ensure that all sectors of the clinical laboratory market are 
included in the reporting of private market rates. CMS has indicated 
that the agency received a number of public comments citing concerns 
that the definition of applicable lab does not represent the whole 
clinical laboratory market. How is CMS addressing these concerns and 
ensuring that the finalized definition of ``applicable lab'' captures 
the complete picture of the clinical laboratory industry?

    Answer. On October 1, 2015, CMS published a proposed rule to 
implement Section 216 of the Protecting Access to Medicare Act of 2014 
(PAMA) requiring applicable clinical laboratories to report on how much 
private insurers pay for laboratory tests, which will be used as the 
basis for new Medicare payment rates. In the proposed rule, CMS 
proposed to define the term ``laboratory'' according to the definition 
used in the Clinical Laboratory Improvement Amendments (CLIA) 
regulations. We also addressed how to meet the statutory requirement 
that an ``applicable laboratory'' receive a majority of its Medicare 
revenues from the clinical laboratory fee schedule or the physician fee 
schedule. In addition, we proposed a low expenditure threshold to 
reduce the reporting burden on small laboratories, as authorized by 
PAMA.

    CMS is currently reviewing the public comments received in response 
to the proposed rule, including many comments regarding the definition 
of an ``applicable laboratory.'' We will carefully consider those 
comments in developing a final rule implementing PAMA Section 216.

                                 ______
                                 
                 Questions Submitted by Hon. Mike Crapo
                                 part b
    Question. On February 5, 2016, CMS posted and then removed a 
notification to contractors of its intent to implement a new Part B 
drug payment model through the Center for Medicare and Medicaid 
Innovation (CMMI).

    CMS's new Part B CMMI demo appears to cover almost all Part B 
beneficiaries and almost all Part B drugs which treat a variety of 
complex conditions and illnesses in the selected regions. In what 
regions will CMS test the model, and how will CMS determine which areas 
will serve as testing versus control groups?

    Answer. We are examining potential ways to support increased access 
to information, drive innovation, and strengthen incentives to improve 
quality care. For any model tested by the Innovation Center, we 
carefully consider the most appropriate design for implementing the 
model so that patients are protected while quality and spending can be 
meaningfully evaluated.\16\
---------------------------------------------------------------------------
    \16\ All responses are accurate as of February 11, 2016.

    Question. Does CMS plan to expand any existing Phase I models? If 
so, how would CMS determine if the model met the statutory criteria 
that the model improves quality of care without increasing spending or 
---------------------------------------------------------------------------
reduces spending without reducing quality of care?

    Answer. We conduct a robust evaluation of all of our models on an 
ongoing basis throughout the life of the model. In every model 
evaluation, we strive to determine the impact of the innovation on the 
experiences of patients and providers, outcomes and quality of care, 
and program expenditures. We make sure that our models are well 
designed--and we use all appropriate scientific and statistical methods 
to study the impact of the model test relative to what would have 
happened in the absence of that model test. We study these results 
carefully in making decisions about models. Prior to any expansions, 
CMS's Chief Actuary must certify that an expansion would not result in 
any increase in net program spending. Using this information, the 
Secretary (or the Secretary's delegate) ultimately determines whether a 
model has met the statutory criteria. To date, the Secretary has 
determined that the Pioneer ACO program has met these criteria.

    Question. Many of the patients who use Part B drugs are patients 
with COPD, cancer, autoimmune conditions and other serious illnesses 
who have few or no other treatment options. Won't the abrupt 
reimbursement changes that will be implemented through this model 
negatively impact access to needed care for these patients? What steps 
are you taking to protect patient access and care quality?

    Answer. Making certain that our beneficiaries receive high quality 
health care--and that the quality of their care improves over time--is 
one of our most important goals. For every model tested, CMS does this 
in two ways--real-time monitoring and rapid-cycle evaluation. First, 
each model has a monitoring strategy that is customized to the specific 
circumstances and model financial structure. Before launching a model, 
CMS carefully considers unintended consequences, such as care stinting, 
and designs monitoring strategies that actively check for such adverse 
outcomes. By receiving regular updates from 1-800-MEDICARE, a model 
team can quickly learn of any potential issues as they arise. Other 
monitoring strategies include: analysis of claims data to identify 
abnormal billing patterns, audits of participants, and analysis of EHR-
based quality measures.

    Second, every model has a rigorous, yet rapid-cycle, evaluation 
conducted by an independent team that unfolds concurrently with model 
implementation. A key component of each evaluation is measuring care 
quality. While each model is different and requires a customized 
evaluation approach, common components include: regular surveys of 
beneficiary experience of care, analysis of claims-based quality of 
care outcomes, and qualitative data collection, such as patient and 
caregiver focus groups. By conducting these activities as the model is 
implemented, the evaluation can quickly identify potential issues with 
care quality and access and allow CMS to take action.
                              biosimilars
    Question. The Patient Protection and Affordable Care Act (PPACA) 
created a carefully balanced formula for biosimilar reimbursement. 
Under the PPACA, Medicare reimburses innovator biological products 
covered under Part B at the average sales price (ASP) plus 6 percent. 
Reimbursement for a biosimilar is the biosimilar's ASP, plus 6 percent 
of the ASP of the reference biologic. However, CMS recently finalized a 
rules stating its intent to change Congress' formula by blending 
reimbursement for biosimilars that share the same reference product. 
CMS finalized the rule even after health care providers, health plans 
and manufacturers expressed significant concerns that this policy would 
harm the emerging biosimilar market.

    Have you considered the potential for this policy to discourage new 
biosimilars from entering the market?

    Answer. We believe the new policy puts appropriate incentives in 
place for new development while helping to contain spending. 
Biosimiliars hold great promise for all Americans, including Medicare 
beneficiaries, and CMS is committed to a payment approach that will 
provide a fair payment in a healthy Marketplace. Competition fosters 
innovations which redefine markets. Overall, the availability of 
generic drugs, in competition with each other and with branded 
products, has improved price and availability of drugs. Competition 
among biosimilars can do the same for Medicare beneficiaries--improving 
quality, price, and access.

    After considering the many comments CMS received on this proposal, 
they finalized a proposal for a biosimilar payment approach that groups 
biosimiliars with a common reference product. They both have 
significant similarities with their predecessor product (a reference 
product for biosimilars and an innovator product for generics) and they 
are both approved through an abbreviated pathway. We believe that 
biosimilars and multiple source drugs will have similar Marketplace 
attributes; like generics, biosimilars will compete for market share 
with each other as well as with the reference product.
                           medicare advantage
    Question. We have seen dramatic volatility between CMS's proposed 
growth rates in Advance Notices and CMS's final growth rates in the 
final Rate Notices over the last few years. For example, for the 2015 
plan year, CMS released a preliminary Medicare Advantage (MA) growth 
rate of -0.1 percent in December, a -1.9 percent growth rate in 
February in the Advance Notice, and a -3.4 percent growth rate in the 
Final Rate Notice in April. For the 2016 plan year, CMS released a 
preliminary MA growth rate of +2.1 percent in December, a +1.7 percent 
growth rate in February in the Advance Notice, and a +4.2 percent 
growth rate in the Final Rate Notice in April.

    What assurances are there that for the 2017 plan year, the +3.0 
percent growth rate proposed by CMS in both December and February will 
remain in the Final Rate notice released in April?

    Answer. Transparency is important and we have taken steps to 
increase transparency, including attaching economic assumptions and 
publishing additional information like the ``Early Preview'' of the 
growth rates 2 to 3 months before the release of the Advance Notice, 
with the aim of providing additional transparency and sharing the 
latest information available about growth rates, as we did on December 
1, 2015. Beginning with the 2015 Advance Notice, we have also included 
historical and projected United States Per Capita Costs values by trust 
fund and year. We welcome your feedback on these issues.

    Question. CMS has failed to provide full transparency on how the 
growth rate is calculated and what components are included. What, if 
any, plan does CMS have to improve the transparency and predictability 
of the growth rate?

    Answer. Key economic assumptions underlying the USPCCs are included 
in an attachment to the annual rate notice. We publish additional 
information regarding the trends for the prior 5 years on our website, 
and we discuss this material on an actuarial user group call.

    Question. Despite support from both parties and from the 
Administration for Quality Incentive Payments in Medicare Advantage, 
those payments have been reduced or eliminated for many 4- and 5-star 
plans because of the PPACA MA benchmark cap. This is a case where a 
strict reading of the law undermines the intent of the PPACA to pay for 
value in Medicare Advantage.

    Will you re-examine your interpretation to find a way that you can 
exclude the quality payments from the calculation of the cap?

    Answer. As part of a larger Medicare Advantage proposal, the 
President's budget would standardize quality bonus payments across 
counties by removing the doubling of the quality bonus payment which is 
only available in certain areas and lifting the cap on benchmarks for 
plans that are entitled to receive a quality bonus payment. This is 
also consistent with MedPAC's unanimous March 2016 recommendations.
                              foster youth
    Question. Can you tell me how CMS is working with States to ensure 
that youth aging out of foster care get continued access to health 
care? What is the data for such coverage and how is CMS working with 
States to identify former foster care youth in need of coverage?

    Answer. As you know, the Affordable Care Act requires each State to 
extend Medicaid coverage to individuals who were in foster care in the 
State but have aged out, and who were enrolled in the State Medicaid 
plan while in foster care. Medicaid coverage on this basis continues 
until age 26. This ensures continuity of Medicaid coverage for children 
aging out of foster care for physical and behavioral health services 
the children might need to live independently.

    CMS has employed several different strategies to help youth aging 
out of foster care retain access to health care. In December 2013, we 
issued guidance to States that explained the ACA requirement for 
coverage of former foster care children. We encouraged child welfare 
agencies and State Medicaid agencies to begin incorporating as soon as 
practicable coverage for this group in the transition planning for 
foster care youth turning 18 that is required of Title IV-E/B agencies. 
CMS has used its State Operations and Technical Assistance (SOTA) 
initiative, as well as the Eligibility Technical Advisory Group, to 
allow States an opportunity to clarify the policy and share best 
practices about its implementation.

    We have required States to include, on their single streamlined 
application for Medicaid, a question about an individual's potential 
eligibility as a former foster youth. We have also confirmed, via 
consultation with States, that their eligibility and enrollment systems 
have the required functionality to determine individuals eligible for 
coverage in this group and, if not, that they have implemented 
appropriate manual processes in the interim. CMS regulations also 
require that States seamlessly transition individuals already enrolled 
in the State Medicaid program while in foster care into coverage under 
this group when they turn 18 or age out of foster care at an older age, 
and we have reinforced this requirement with every State, both 
individually and on all-State audio-conferences.

    CMS has also worked with consumer advocacy and support 
organizations, and with other organizations engaged with vulnerable 
youth, to ensure that they are able to facilitate the application and 
enrollment of individuals who may be eligible as former foster youth. 
In 2015, through our Connecting Kids to Coverage Campaign, CMS 
conducted webinars for application assistors and other outreach workers 
about this coverage, to provide them with the information they need to 
assist young adults formerly in foster care in obtaining coverage.

    States have not yet reported data to CMS on the number of former 
foster care children enrolled in this new Medicaid eligibility 
category. We anticipate that the Transformed Medicaid Statistical 
Information System (T-MSIS), once fully operational with updated 
information from all States, will include these data and enable CMS to 
provide reliable information about the extent of coverage of this 
population.

    Question. Some States, like New Jersey, have coordinated child 
welfare and behavioral health programs to help youth get services they 
need and safely stay with their families. What is CMS doing to 
highlight the success of such coordination and encourage more States to 
collaborate?

    Answer. HHS is committed to supporting States' efforts to 
coordinate child welfare and behavioral health programs. CMS has issued 
several Informational Bulletins on children's mental health services 
and substance use disorder treatment services offered through Medicaid, 
as well as several informational bulletins focused on addressing trauma 
for children and youth who are at risk of placement in the foster care 
system. These policy guidance documents describe how various Medicaid 
programs and services help children live more successfully in the 
community and with their families. These Informational Bulletins may be 
accessed at www.
medicaid.gov.

    For example, we have worked closely with our Federal and State 
partners to address the needs of children and youth, especially those 
in the foster care, who have experienced trauma, which is closely tied 
to the over-prescription of psychotropic medications. This has included 
information to States regarding the interventions that address trauma 
and the various Medicaid authorities that are available to States for 
covering these services. In addition, the President's 2017 budget 
includes a demonstration program to address the use of these 
medications among youth in foster care. This demonstration is a joint 
program with Administration for Children and Families that would 
provide the tools and incentives for States to increase access to 
services that address trauma and over-prescription of psychotropic 
medications.

                                 ______
                                 
              Questions Submitted by Hon. Robert Menendez
                  marketplace out-of-pocket calculator
    Question. I applaud HHS for including an out-of-pocket (OOP) cost 
calculator tool to HealthCare.gov this past open enrollment season. 
This tool has the potential to allow those shopping for coverage to 
have a more complete understanding of the costs they could incur on the 
various Marketplace plans available to them, ensuring that they enroll 
in the best plan for them and their family. This is especially 
important when it comes to prescription drug costs. However, in its 
current form, the OOP calculator tool has not reached that potential 
and does not allow enrollees to get results personalized to their 
specific prescriptions. This lack of personalization could end up 
providing enrollees with misleading information, and lead them to 
enrolling in the least optimal plan. While I understand that some 
limitations could exist to make providing such personalization 
difficult, that functionality has been part of the Medicare Part D Plan 
Finder tool since it's launch in 2006. This would indicate that 
providing all beneficiaries with the ability to gauge the actual OOP 
based on their specific prescription medication needs.

    Why do federally-facilitated Marketplaces lack the same 
personalized OOP calculators as those available for Part D plans? Does 
HHS expect this level of personalization to be available starting with 
next year's open enrollment period? If not, why?

    Answer. Based on consumer feedback about the information they want 
to help pick the right health plan, a number of new features have been 
developed for HealthCare.gov. As you note, a new Out of Pocket Cost 
calculator has helped consumers better estimate the cost of their 
health insurance based on their own personal situation. The feature 
provides consumers with an estimate of what their premiums, 
deductibles, and co-pays may be, based on their own anticipated level 
of health care service utilization, for each specific plan. 
Understanding total out of pocket costs for any given coverage option 
is essential for consumers to select the most affordable plan. In 
addition to the out-of-pocket cost calculator we also added a 
prescription-drug lookup feature for the 2016 Open Enrollment, where 
consumers can check whether a plan covers their prescription drug. 
Consumers can get this information before they select a plan. The 2016 
Open Enrollment was the first year for both of these features and we 
expect that as the Marketplace matures that these tools will continue 
to be refined and improved over time.
                              puerto rico
    Question. As you know, section 601 of the Consolidated 
Appropriations Act of 2016 (Pub. L. 114-113) updated the Medicare 
hospital Inpatient Prospective Payment System (IPPS) to provide some 
reimbursement equity to hospitals in Puerto Rico. Prior to this law 
being enacted, hospitals in Puerto Rico were reimbursed under the IPPS 
at a blended rate--25 percent based on a Puerto Rico-specific rate, 
with the remaining 75 percent based on the Federal rate. Thanks to this 
new law, hospitals in Puerto Rico will be reimbursed at a full 100 
percent Federal rate, just like their counterparts in the 50 States and 
District of Columbia. It has been brought to my attention that CMS 
recently issued guidance on this provision and is only applying the 100 
percent Federal rate to the hospital operational costs, while 
maintaining the 25/75 blended rate for the capital expenses. While this 
continued inequity was clearly not the intent of Congress, I recognize 
that the capital expense calculations are done in regulations under the 
broad authority provided to HHS by section 1186(g) of the Social 
Security Act. However, it is imperative that hospitals in Puerto Rico 
receive the full equity in IPPS payments intended by Congress as soon 
as possible.

    To that end, can you confirm that the upcoming IPPS rule will 
include updates to the special capital rate for Puerto Rico hospitals, 
effective October 1, 2016, to bring it inline with the 100 percent 
Federal rate mandated by Congress? In the meantime, what immediate 
steps will be taken to provide hospitals in Puerto Rico with the full 
equity in reimbursements prior to an October 1st effective date in the 
IPPS rule?

    Answer. HHS has taken a number of steps to help residents of Puerto 
Rico access quality and affordable health care and a more sustainable 
future and we will continue to look for additional opportunities. CMS 
is reviewing its rulemaking authorities to address this issue and will 
keep your staff updated when relevant rules are issued.

                                 ______
                                 
               Questions Submitted by Hon. Sherrod Brown
                       combating infant mortality
    Question. Ohio ranks 45th in the Nation in infant mortality--and 
even worse among the States that collect data on African American 
infant mortality. Many organizations in Ohio have partnered with 
community leaders and providers to address this issue, and I am 
encouraged by their creative and innovative approaches to improve the 
infant mortality rate in our State.

    A specific example is the Community Health Access Project (CHAP) in 
my hometown of Mansfield, OH. CHAP utilizes a ``Pathways'' model, which 
allows community health workers (CHWs) to connect expectant mothers 
with nurses, doctors, and social workers. Through CHWs, CHAP is able to 
ensure that patients' needs--health, behavioral, housing, educational, 
and emotional--are met in a coordinated fashion.

    CHAP's initial focus was on at-risk pregnant women--with a goal of 
reducing the number of babies born at a low birthweight. The results 
have been impressive. In 1999, nearly a quarter (22.7%) of babies in 
Mansfield were born at low birth weights (less than 5l bs, 8 oz). By 
2008, that number had been reduced to 8 percent.

    CHWs are integral to the success of CHAP, and have already been 
invaluable in Ohio's effort to reduce infant mortality. The Affordable 
Care Act has helped expand opportunities for CHWs to contribute to 
increased value and care coordination, however, we should continue to 
evaluate ways in which CHW can be leveraged to improve health outcomes.

    What resources are available through this proposed budget to ensure 
that we are maximizing the potential of CHWs, and ensuring that CHWs 
have adequate resources and funding to fulfill their vital role?

    Answer. I appreciate your leadership on the critical issue of 
infant mortality, and I am glad to learn more about the Community 
Health Access Project in Mansfield. The Health Resources and Services 
Administration's Maternal and Child Health Bureau (MCHB) FY 2017 budget 
request supports the use of Community Health Workers (CHWs) in the 
Maternal, Infant, and Early Childhood Home Visiting (Home Visiting) and 
Healthy Start programs. Details on each of these programs, and their 
support for CHWs, are included below.

    The Home Visiting Program supports voluntary, evidence-based home 
visiting services for at-risk pregnant women and parents with young 
children up to kindergarten entry in all 50 States, the District of 
Columbia, and five territories. The Ohio Department of Health, a grant 
recipient of the Federal Home Visiting Program since 2010, has 
implemented Healthy Families of America, an evidence-based model that: 
aims to reduce child maltreatment; improve parent-child interactions 
and children's social-emotional well-being; increase school readiness; 
promote child physical health and development; promote positive 
parenting; promote family self-sufficiency; increase access to primary 
care medical services and community services; and decrease child 
injuries and emergency department use. The model requires home visitors 
(family support staff) have a minimum of a high school diploma, as well 
as experience working with culturally diverse communities, and 
providing services to children and families, and have the ability to 
establish trusting relationships. These staff requirements and 
qualifications are consistent with the requirements for community 
health workers (CHWs).

    The Healthy Start (HS) program aims to reduce disparities in infant 
mortality and adverse perinatal outcomes by: (1) improving women's 
health; (2) promoting quality services; (3) strengthening family 
resilience; (4) achieving collective impact; and (5) increasing 
accountability through quality improvement, performance monitoring, and 
evaluation. HRSA funds five HS communities in Ohio (Cincinnati, 
Cleveland, Columbus, Dayton, and Toledo). Since its establishment in 
1991, HS has had a strong commitment to the use of CHWs. CHWs provide 
outreach and client recruitment, case management, and follow up and 
referral services; and enroll eligible women and their families into 
health insurance.

    Question. How will HHS work with States, localities, and other 
stakeholders to promote the inclusion of CHWs in various health care 
programs? Has HHS considered proposing reimbursement models to support 
the role of CHWs in team based care?

    Answer. HRSA supports community health workers (CHWs) through 
grants or cooperative agreements, which are a form of Federal financial 
assistance. Grants and cooperative agreements provide funding to 
address an identified public need, and are not a form of reimbursement.

    The Healthy Start and Home Visiting programs are examples of how 
HHS currently works with States, localities, and other stakeholders on 
health care programs targeted toward mothers and babies that include 
CHWs. Further, State title V programs support the use of CHWs to 
provide outreach/health education and to assist the maternal and child 
health (MCH) population in gaining access to needed services. Based on 
their identified MCH priority needs, States have discretion in 
determining the types of activities that they support under their title 
V MCH Block Grant funds, which include support for CHWs, based on the 
needs of the State's MCH population and the availability of other 
resources.

    HHS also utilizes CHWs across the Department. The Federally 
qualified health center or health center network teams include CHWs to 
coordinate patient education, link families to community resources, and 
make referrals to social services such as Supplemental Nutrition 
Assistance Program (SNAP) and Women, Infants, and Children (WIC). The 
Center for Medicare and Medicaid Innovation has also fostered the use 
of CHWs through their Health Care Innovation Awards, State Innovation 
Models, and Multi-Payer Advanced Primary Care demos to provide support 
to CHWs and to encourage their integration into care delivery. 
Additionally, Community Health Representatives have been part of the 
Indian Health Service delivery system model for decades.

    Question. Will you come visit CHAP so you can see first-hand the 
impact these individuals have on the health of many Ohioans?

    Answer. Thank you for the invitation to visit your hometown and for 
your leadership in fighting for access to health care for all 
Americans. My staff has been working with your office to determine 
whether this trip will be possible.
                     third party premium assistance
    Question. After CMS released its Interim Final Rule entitled Third 
Party Payment of Qualified Health Plan Premiums in March 2014, a 
growing number of insurance carriers have refused to accept third party 
payments from non-profit organizations on behalf of low-income people 
with high-cost conditions who are enrolled in Marketplace plans.

    As you know, the Interim Final Rule allows marketplace insurance 
plans to prohibit the acceptance of health insurance premium assistance 
from non-profit organizations. This means that charitable organizations 
such as the Rotary Club, churches, the American Kidney Fund, and 
Patient Services Inc., are excluded from providing third party premium 
assistance. However, the rule recognizes the value of many 
organizations that provide premium assistance and therefore mandates 
that health insurance providers in the State and Federal insurance 
marketplaces must accept third party premium assistance from certain 
entities, including State AIDS Drug Assistance Programs (State ADAPs), 
Indian Tribes/Tribal Organizations, and any other State and Federal 
assistance programs.

    Why does HHS require insurers to accept third party premium 
assistance for certain categories of coverage (Federal, State, tribal 
and Ryan White HIV/AIDS programs), but permits insurer discretion to 
deny all other third-party payments from non-profits on behalf of 
insured people with chronic conditions? Is there anything in the 
statute that bars you from requiring Marketplace plans to accept 
premium assistance from charitable organizations?

    Answer. In the Interim Final Rule with comment ``Patient Protection 
and Affordable Care Act: Third Party Payment of Qualified Health Plan 
Premiums,'' issued in March 2014, CMS required QHP issuers to accept 
payment from entities such as the Ryan White HIV/AIDS Program, tribes, 
tribal organizations and urban Indian organizations, in part because 
Federal or State law authorizes, or policy specifically envisions third 
party payment of premium and cost-sharing amounts by these entities.

    For example, section 402 of the Indian Health Care Improvement Act 
and the relevant regulations, which implement the Affordable Care Act, 
provide that Marketplaces may permit Indian tribes, tribal 
organizations and urban Indian organizations to pay aggregated QHP 
premiums on behalf of qualified individuals, subject to terms and 
conditions determined by the Marketplace.

    In addition, the Ryan White HIV/AIDS Program has been authorized to 
provide insurance assistance for low-income people living with HIV 
since 1990 under the Ryan White Comprehensive AIDS Resources Emergency 
(CARE) Act. States have the authority to use AIDS Drug Assistance 
Program grant funds to purchase or maintain health insurance or plans 
when the coverage includes the relevant therapeutics and the cost of 
such coverage does not exceed the costs of otherwise providing the 
therapeutics directly. This provision was added in 2000 by the Ryan 
White CARE Act Amendments of 2000.

    As noted in the November 4, 2013 FAQ, it has been suggested that 
hospitals, other health care providers, and other commercial entities 
may be considering supporting premium payments and cost-sharing 
obligations with respect to qualified health plans purchased by 
patients in the Marketplaces. HHS has significant concerns with this 
practice because it could skew the insurance risk pool and create an 
uneven field in the Marketplaces.

    CMS later clarified that the concerns addressed in the November 4, 
2013 FAQ would not apply to payments from private, not-for-profit 
foundations if they are made on behalf of QHP enrollees who satisfy 
defined criteria that are based on financial status and do not consider 
enrollees' health status. In such situations CMS would expect that 
premium and any cost sharing payments cover the entire policy year.

    Question. Due to the restrictions on charitable organizations like 
those listed above, CMS's regulations are--in some ways--undermining 
the Affordable Care Act's reform to the pre-existing condition. In 
fact, insurers in more than 30 States--including Ohio--have announced 
their intention to reject premium assistance payments from charitable 
organizations. This has given insurers the ability to reject payment 
assistance for individuals with pre-existing conditions, discouraging 
those individuals from seeking coverage. In addition, insurers are now 
migrating these discriminatory practices to Medigap, COBRA, and other 
types of insurance as well.

    What appropriate guardrails could be put in place that would both 
protect patients' access to qualified premium assistance plans--while 
also addressing insurer concerns about the risk pool?

    Answer. The Affordable Care Act reformed the health insurance 
marketplace to ensure that individuals with pre-existing conditions are 
able to access care and to prohibit non-grandfathered insurance plans 
from discriminating against consumers with pre-existing conditions or 
charging them more because they got sick or placing annual or lifetime 
limits on their insurance. In addition, with respect to the Marketplace 
specifically, the ACA provides for both tax credits to help consumers 
afford their premiums, and reduced cost-sharing for consumers who 
qualify. These market reforms and financial assistance work together to 
ensure access to care.

    As noted in the HHS Notice of Benefit and Payment Parameters for 
2017 proposed rule, HHS is considering whether to expand the list of 
entities from which issuers are required to accept payment to include 
not-for-profit charitable organizations in future years. If such not-
for-profit charitable organizations were included, HHS would also 
intend to include guardrails aimed at minimizing the impact on the risk 
pool, such as limiting assistance to individuals not eligible for other 
Minimum Essential Coverage and requiring assistance until the end of 
the calendar year.

    Question. Non-profit organizations have a long and proven track 
record of helping people with chronic conditions maintain affordable 
health coverage. For example, for individuals who have been diagnosed 
with end-stage renal disease (ESRD), where average out-of-pocket costs 
are $7,000, enrollment in a Marketplace plan--even if a Marketplace 
plan is their preferred choice--remains out of reach and not a 
meaningful option without premium assistance.

    Why would it be acceptable to deny the same protections to people 
battling kidney disease and other high cost conditions--as you've 
applied to those with HIV/AIDS? Do you agree that both groups should be 
protected from discriminatory insurance practices?

    Answer. The Affordable Care Act reformed the health insurance 
marketplace to ensure that individuals with pre-existing conditions are 
able to access care by to prohibit non-grandfathered insurance plans 
from discriminating against consumers with pre-existing conditions or 
charging them more because they got sick or placing annual or lifetime 
limits on their insurance. In addition, the ACA provides for both tax 
credits to help consumers afford their premiums, and reduced cost-
sharing for consumers who qualify. These market reforms and financial 
assistance work together to ensure access to care.

    In the Interim Final Rule, CMS required QHP issuers to accept 
payment from entities such as the Ryan White HIV/AIDS Program, tribes, 
tribal organizations and urban Indian organizations, in part because 
Federal or State law authorizes, or policy specifically envisions third 
party payment of premium and cost-sharing amounts by these entities. 
Specifically, section 402 of the Indian Health Care Improvement Act and 
related regulations, which implement the Affordable Care Act, provide 
that Marketplaces may permit Indian tribes, tribal organizations and 
urban Indian organizations to pay aggregated QHP premiums on behalf of 
qualified individuals, subject to terms and conditions determined by 
the Marketplace.

    The Ryan White HIV/AIDS Program has been authorized to provide 
insurance assistance for low-income people living with HIV since 1990 
under the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act. 
The Public Health Service Act provides authority for States to use AIDS 
Drug Assistance Program grant funds to purchase or maintain health 
insurance or plans when the coverage includes the relevant therapeutics 
and the cost of such coverage does not exceed the costs of otherwise 
providing the therapeutics directly. This provision was added in 2000 
by the Ryan White CARE Act Amendments, and was subsequently 
renumbered.As noted in the November 4, 2013 FAQ, HHS has significant 
concerns with third party payments because they could skew the 
insurance risk pool and create an unlevel field in the Marketplaces.
                       medicaid and job readiness
    Question. Medicaid managed care plans--particularly non-profit 
community-based plans--play a unique role in its members' lives by 
helping connect beneficiaries not only to necessary healthcare 
services, but to other critical resources that help address health 
disparities across communities. Health plans are focusing on ways to 
increase access to affordable transportation, eliminate food deserts 
and improve nutrition, and even provide job readiness programs for 
their members.

    What funding exists within HHS that would support Medicaid health 
plans voluntarily engaging their members to determine work readiness, 
provide job skills and mentor their beneficiaries through employment?

    For example, in my home State of Ohio, there is an outstanding 
pilot that was launched using philanthropic funding, to do just this 
type of work and it's proving successful. We need to support this type 
of program to help lift people out of poverty and connect them with 
stable, living-wage employment opportunities.

    Can you please identify and report to the committee existing and 
potential means to support this program with the support of Federal 
programs and dollars?

    Answer. I would like to learn more about the specific pilot you 
mention here and encourage you to reach out to Jim Esquea, my Assistant 
Secretary for Legislation, to discuss it further. Additional 
information will help us determine whether the pilot would be eligible 
for funding opportunities.

    With respect to your question about support for States more 
broadly, CMS supports State efforts to provide supportive employment in 
both managed care and fee-for-service delivery systems. Supportive 
employment provides a wide array of services and supports to increase 
employment opportunities for individuals with disabilities. Medicaid 
provides Federal financial participation (FFP) for employment supports 
related to an individual's physical or mental condition that are not 
covered through other means (such as Vocational Rehabilitation or DOL 
funded supports) when a State elects to cover them under a long term 
care authority under either a managed care or fee for service payment. 
Specifically, States have the opportunity to provide Supported 
Employment Services through a 1915(c) Home and Community-Based Waiver 
authority and/or through the 1915(i) State Plan benefit. States also 
have the option to operate a 1915(c) or 1915(i) program under a managed 
care system. There are currently 288 1915(c) HCBS Waiver programs and 
18 1915(i) State Plan benefits operating nationwide. Under either 
authority the Federal Government will provide FFP for Supported 
Employment if the State elects to include the service. For more 
information on supportive employment, including best practices for 
States in implementing their programs is available at: https://
www.medicaid.gov/federal-policy-guidance/downloads/CIB-09-16-2011.pdf. 
Finally, consistent with current regulations, a State may also craft 
individual incentive arrangements for managed care plans that meet 
defined employment outcomes in its disabled and elderly populations.
             strategies to address prescription drug abuse
    Question. Ohio has seen devastation from the epidemic of 
prescription drug abuse. In 2014, Ohio was one of five States with the 
highest rates of death due to drug overdose and more than 2,700 Ohioans 
overdosed on drugs, including prescription opioids. Those are startling 
numbers.

    The situation is serious, but it isn't hopeless. There are steps we 
know we can take to reduce these numbers--and save lives. I was pleased 
to see that the President's budget included support for patient review 
and restriction programs. These programs reduce the likelihood that 
people will doctor shop and get multiple prescriptions from multiple 
providers or pharmacies. We know that they work in the private sector. 
But Medicare can't use this potentially lifesaving tool. The time has 
come to give Medicare this authority.

    That's why Senators Toomey, Kaine, Portman, and I have introduced 
the ``Stopping Medication Abuse and Protecting Seniors Act,'' which 
would let Medicare better protect seniors from dying from drug 
overdoses, and at the same time ensure that patients who need pain 
medication can get it.

    Will you work with my office and this committee to pass this 
important legislation?

    Answer. First, I would like to thank you and Senator Toomey for 
your leadership on this issue. We would be happy to work with you on 
this legislation, as a very similar proposal is included in the 
President's FY17 budget. The prescribing aspect of the opioid epidemic 
is an important part of this complex public health issue, and using all 
of the tools available to us within HHS is a key part of our Opioid 
Initiative. The Initiative is a coordinated, multi-faceted approach 
that relies on education, prevention and treatment strategies with the 
strongest evidence base. Assisting health care professionals in making 
informed prescribing decisions, increasing the use of naloxone and 
expanding access to medication-assisted treatment for opioid use 
disorder are the key areas where we are focusing our efforts through 
the initiative, to deliver the greatest impact. At the same time, it is 
critical to balance combatting opioid misuse with the use of these 
drugs for legitimate purposes and supporting appropriate pain 
management.

    The President's FY17 budget included critical investments to 
intensify efforts to reduce opioid abuse and overdose, including an 
increase of $1.1 billion in mandatory and discretionary funding to 
build on these and other investments proposed by the administration and 
funded by the Congress in FY 2016. Another proposal to prevent 
prescription drug abuse in Medicare Part D would give the HHS Secretary 
authority to establish a program in Medicare Part D that would require 
that high-risk Medicare beneficiaries only utilize certain prescribers 
and/or pharmacies to obtain controlled substance prescriptions, similar 
to requirements many States have implemented in Medicaid. The Medicare 
program would be required to ensure that Medicare beneficiaries retain 
reasonable access to Medicare services of adequate quality, and, in 
addition, the restricted period for a given beneficiary could only last 
for ``a reasonable period of time.''

    We have also seen some success in Medicare Part D where utilization 
review processes have reduced high end opioid use significantly. We 
continue to work across HHS, with our partner agencies and other 
stakeholders, and with Congress to identify and dismantle barriers as 
well as leverage our resources to effectively implement strategies to 
reduce the impact of opioid use disorder and overdose death.

    We are very pleased by Congress's continued interest and support, 
and we would be happy to provide technical assistance and work with 
your offices to continue the progress and ultimately turn the tide of 
this epidemic.

                                 ______
                                 
   Question Submitted by Hon. Robert Menendez and Hon. Sherrod Brown
   protecting access to medicare act--clinical laboratory provisions
    Question. In 2014, Congress passed the Protecting Access to 
Medicare Act (PAMA; Pub. L. 113-93) to make several needed updates and 
changes to the Medicare program. Included in this law was a substantial 
update to the way Medicare prices, and therefore reimburses, services 
provided to beneficiaries by clinical laboratories. Specifically, PAMA 
requires that laboratories report to the Centers for Medicare and 
Medicaid Services (CMS) the rates and volume of tests paid by private 
payers. CMS is then directed to use this information to calculate new 
Medicare reimbursement rates using the weighted median of the reported 
private payer rates.

    Late last year, we joined 17 of our colleagues in sending a letter 
to Acting CMS Administrator Andy Slavitt inquiring about CMS's actions 
on implementing this section of PAMA. The letter highlighted as the 
primary concern CMS's intent to use taxpayer identification numbers 
(TINs) to determine which laboratories are subject to the private payer 
reporting requirement. Based on CMS's own internal calculation they 
``do not expect hospital laboratories to meet the definition of an 
applicable laboratory, and . . . estimate that more than 50 percent of 
independent laboratories and more than 90 percent of physician offices 
will be precluded from providing private payer data.'' While Congress 
clearly intended on excluding many smaller and low-volume laboratories 
from the reporting requirement, CMS's exclusion of much of the 
laboratory industry, specifically hospital labs, will cause a 
potentially significant skewing of the pricing data. This will, in 
turn, result in inaccurate reimbursements throughout the Medicare 
clinical lab fee schedule.

    As we wait for a response to the previously mentioned letter, there 
are timely issues we want you to address in the meantime. Specifically, 
what steps is CMS taking now to ensure that the full breadth and depth 
of the clinical laboratory industry is represented in the incoming 
private payer data? Will CMS consider using the Medicare National 
Provider Identifier (NPI) instead of the TIN to better account for more 
labs? If not, what remediating measures will be taken to ensure the 
data, and ultimately the new reimbursements, are as accurate as 
possible and do not cause any disruption in Medicare laboratory 
services or beneficiary access to care?

    Additionally, under PAMA, CMS was required to issue final 
rulemaking on these updated reimbursements by June 30, 2015. This date 
was specifically chosen by Congress to ensure sufficient time for 
laboratories to properly report their private payer rates and to allow 
CMS time to create the necessary systems to collect, certify, report 
and calculate this new data in time for the statutorily-mandated 
January 1, 2017, effective date. Despite this statutory deadline, CMS 
didn't issue a proposed rule until October 1, 2015, and has yet to 
release a final rule. Given the ongoing delay in issuing a final rule, 
it seems implausible to assume everything will be ready for 
implementation by January 1, 2017.

    What is the status of the final rule and when does CMS expect it to 
be released? Does CMS plan on providing laboratories and other key 
stakeholders additional time to properly comply with the yet-unreleased 
final rule beyond the January 1, 2017 deadline?

    Answer. Senators, thank you for raising this issue. I believe CMS 
has responded to your letter, but will work with my staff to be sure 
you receive a copy if you have not already.

    As you noted, on October 1, 2015, CMS published a proposed rule to 
implement section 216 of the Protecting Access to Medicare Act of 2014 
(PAMA) requiring applicable clinical laboratories to report on how much 
private insurers pay for laboratory tests, which will be used as the 
basis for new Medicare payment rates. In the proposed rule, CMS 
proposed to define the term ``laboratory'' according to the definition 
used in the Clinical Laboratory Improvement Amendments (CLIA) 
regulations, and to define an ``applicable laboratory'' at the Taxpayer 
Identification Number (TIN) level rather than the National Provider 
Identifier (NPI) level. CMS also addressed how to meet the statutory 
requirement that an ``applicable laboratory'' receive a majority of its 
Medicare revenues from the clinical laboratory fee schedule or the 
physician fee schedule. In addition, we proposed a low expenditure 
threshold to reduce the reporting burden on small laboratories, as 
authorized by PAMA.

    CMS is currently reviewing the public comments received in response 
to the proposed rule, including many comments regarding the definition 
of an ``applicable laboratory'' and whether to use the TIN or NPI in 
defining such laboratories. We will carefully consider those comments 
in developing a final rule implementing PAMA section 2016, which we 
expect to be available soon.

                                 ______
                                 
    Questions Submitted by Hon. Bill Nelson and Hon. Mark R. Warner
    Question. As you know, prescription drug prices are of significant 
concern to millions of Americans. United States spending on 
prescription drugs is now growing at a rate faster than any other 
healthcare item or service, and, in 2014 alone, prescription drug 
spending rose by 12.2 percent.

    Your budget recognizes the roles that the U.S. Department of Health 
and Human Services (HHS) and Centers for Medicare and Medicaid Services 
(CMS) play in limiting the impact of these rising costs and exploring 
alternative payment mechanisms for prescription drugs. The squeeze of 
these rising costs is being felt by both American families and also the 
budgets of Federal programs and State governments. Investments in and 
development of innovative drugs can provide life-saving treatments, yet 
we must ensure there is a balance between the prices we pay for these 
prescription drugs and the value they provide.

    Given these roles, consider the following questions:

    What recent actions have HHS and CMS been taking to put in place 
initiatives to move to a value-based payment system for prescription 
drugs? What additional investments does the FY 2017 budget proposal 
make to conduct comparative effectiveness research of prescription 
drugs to facilitate approaches that pay for value?

    Answer. HHS has taken several steps to lay the groundwork to 
improve value in our health care system. Such steps include:

          Medicare Drug Spending Dashboard: In December, HHS announced 
        a new online dashboard to provide information on Medicare 
        spending on prescription drugs, for both Part B (drugs 
        administered in doctors' offices and other outpatient settings) 
        and Part D (drugs patients administer themselves) to provide 
        additional information and increase transparency. Having this 
        information available to the public in an accessible format 
        should inform health care decisions and policy considerations 
        as well as encourage collective problem solving around these 
        important issues.

          HHS Forum: In November, HHS convened a forum that brought 
        together consumers, providers, employers, manufacturers, health 
        insurance companies, representatives from State and Federal 
        Government, and other stakeholders to discuss ideas on how our 
        country can meet the dual imperatives of encouraging drug 
        development and innovation, while ensuring access and 
        affordability. The conversation touched on many ideas to 
        increase access to information, promote value, drive 
        innovation, strengthen incentives and promote competition.

          Payments for Biosimilars: In November, as part of the 
        Physician Fee Schedule, CMS finalized regulations clarifying 
        that the payment amount for a biosimilar biological product is 
        based on the average sale price of all biosimilar biological 
        products included within the same billing and payment code.

          Oncology Care Model: In the spring of 2015, Center for 
        Medicare and Medicaid Innovation developed a payment model for 
        physician practices administering chemotherapy. Under this 
        model, practices will enter into payment arrangements that 
        include financial and performance accountability for episodes 
        of care surrounding chemotherapy administration to cancer 
        patients. This model aims to provide higher quality, more 
        highly coordinated oncology care at a lower cost.\17\
---------------------------------------------------------------------------
    \17\ All responses are accurate as of February 11, 2016.

    Question. How does the agency propose to use comparative 
effectiveness information, claims data, electronic health records, and 
other available health data on diagnosis, utilization, and cost to 
---------------------------------------------------------------------------
improve the prescription drug payment system?

    Answer. We believe that data and information is key to supporting 
better decision making regarding prescriptions drugs on the part of 
patients, providers, policy makers, and others in the health care 
system.

    We have taken steps recently to support informed and value-based 
decision-
making specifically in Medicare. The Medicare Drug Spending Dashboard 
provided the first step towards improving access to information, by 
providing information on the high spend drugs in Medicare, along with 
links to available evidence on the efficacy of those drugs.

    With regards to the budget proposals, we include several that 
support the administration's broader strategy to encourage better care, 
smarter spending, and healthier people by paying for what works, 
improve care coordination and integration, and distribute information 
to providers, consumers, and others to support better decisions while 
maintaining privacy. For example, we propose to allow the Secretary to 
negotiate prices for biologics and other high cost drugs, which will 
help control spending.

    Question. The FY 2017 budget also proposes new transparency 
requirements that would help shine a light on factors that are driving 
drug pricing and costs. What does transparency mean in this case? How 
does HHS propose to ensure that patients and others are aware of this 
information, as well as the results of value-based evaluations?

    Answer. Providing access to information such as the factors that 
underlie drug pricing can help inform decision making by policy makers, 
providers, and patients, and shift the focus on drug pricing to the 
value the drug brings to the health care system. Working with various 
stakeholders across all sectors of the health care system will be 
important to make sure that such information is useful to and is used 
by patients and others.

    Question. The budget creates a new process for developing a 
``coverage with evidence development'' policy for Part D drugs, so that 
Part D plans can use additional evidence to improve clinical treatment 
guidelines and coverage policies. Please provide information on how HHS 
plans to develop this process, and which drugs and subpopulations are 
likely to be the focus of initial development.

    Answer. This proposal would be modeled in part after the coverage 
with evidence development process in Parts A and B of Medicare to 
ensure that Part D sponsors provide the highest value prescription drug 
benefits for high cost drugs.

    First, CMS would establish uniform criteria and a process for 
evaluating the value of new high cost drugs entering the market. Next, 
CMS would set up an advisory committee to assist with evaluating the 
value of specific high cost drugs.

    As a condition of coverage of these high cost drugs in Part D, 
manufacturers would be required to undertake further clinical trials 
and data collection to support use in the Medicare population, and for 
any relevant subpopulations identified by CMS. Evidence developed 
through this process would support plan management of these drugs 
through existing tools such as prior authorization and differential 
formulary placement.

                                 ______
                                 
                Questions Submitted by Hon. Bill Nelson
    Question. The most glaring example of Puerto Rico's critical 
underfunding of health care services is that U.S. citizens living in 
Puerto Rico are ineligible for the Medicare Prescription Drug Low-
Income Subsidy (LIS) Program. This is why I introduced S. 2342, the 
Territories Medicare Prescription Drug Assistance Equity Act, which 
will help low-income seniors living on the Island afford their 
prescription drugs by making them eligible for the Medicare Part D Low 
Income Subsidy program--a program that's already available to seniors 
living in the U.S. mainland.

    Since 2008, the administration has promised a similar fix to aid 
the citizens living in the U.S. Territories. Extending the Medicare 
Part D LIS program to the U.S. Territories would provide relief to 
approximately 60 percent of Puerto Rico's 730,000 Medicare 
beneficiaries. Does the administration believe that this type of 
solution is effective in alleviating some of the strain on Puerto 
Rico's health system?

    Would the administration support the solution proposed in the 
Territories Medicare Prescription Drug Assistance Equity Act to improve 
health care access in Puerto Rico?

    Answer. Senator, first let me thank you for your leadership on 
these issues. HHS is committed to helping Puerto Rico with the health 
aspects of its current fiscal challenges. Under statute, many HHS 
programs, including Medicare and Medicaid, are implemented differently 
in Puerto Rico. In addition, Puerto Rico has a unique health care 
market with many low-income individuals in both Medicare and Medicaid 
and a complex legal history that affects the health care system in many 
ways. We are cognizant of the particular challenges in not only Puerto 
Rico, but in all territories without Low Income Subsidy (LIS) and would 
support an additional analytical adjustment for contracts serving these 
areas exclusively to address the fact that the part D LIS is not 
available there. That said, we believe that the single most impactful 
step we can take is reforming Puerto Rico's Medicaid program. As part 
of the President's FY17 budget, the administration detailed its 
proposal to improve health care outcomes in Puerto Rico and prevent 
hundreds of thousands of Americans from losing access to health care. 
The proposal would lift the Federal cap on Medicaid funding to Puerto 
Rico and other U.S. territories, raise the Federal Medicaid match from 
55 percent to 83 percent over time as territories strengthen and 
modernize their Medicaid programs, and expand eligibility to 100 
percent of the Federal poverty level over time. These reforms are 
integral to the administration's broader roadmap to financial stability 
for Puerto Rico.

    I appreciate your ongoing leadership for the people of Puerto Rico, 
and look forward to working with you on this important issue.

    Question. I appreciate the thought and preparation that went into 
the President's request for emergency funding to combat Zika virus. I 
have a unique interest in this issue given Florida's long history with 
mosquito-borne illnesses. Florida last dealt with outbreaks of dengue 
fever and chikungunya, two diseases also transmitted by the same 
mosquito as Zika virus, in 2013 and 2014.

    The potential for Zika virus transmission is great. Currently, 
there are 32 travel-related Zika cases spread across 11 counties in 
Florida, including three pregnant women. There is no cure, vaccine, or 
treatment for Zika virus and current diagnostic tests are also 
inadequate.

    I joined Senators Brown, Isakson and Franken in introducing S. 
2512, the Adding Zika Virus to the FDA Priority Review Voucher Program 
Act. This bill would add Zika virus to the list of diseases included in 
the Tropical Disease Priority Review Voucher program at the FDA. You 
can take this important step on your own, without congressional action.

    Do you have any plans to add Zika virus to the list of tropical 
diseases?

    Answer. HHS is committed to doing all that it can to facilitate the 
development of, and access to, medical products to respond to the Zika 
virus outbreak as quickly as possible. We fully believe that the 
incentives currently available for Zika product development--such as 
funding for research and development and clinical trial costs from 
government and non-governmental organizations--as well as extensive HHS 
technical assistance for product developers, are sufficient to help 
bring Zika products to market. As demonstrated during the Ebola 
response, FDA will provide all the necessary support to product 
developers and use its authorities to the fullest extent appropriate to 
help facilitate and expedite development of Zika virus medical 
countermeasures. In addition, it is likely that Zika virus medical 
countermeasures will be eligible for FDA's proven mechanisms to speed 
the availability of medical products for serious diseases, such as 
priority review, fast track designation, and potentially accelerated 
approval.

    As you are aware, the Federal Food, Drug, and Cosmetic Act sets 
forth the conditions under which the Secretary of HHS is authorized to 
add infectious diseases to the list of tropical diseases that would 
qualify the developer of a licensed or approved product to prevent or 
treat an identified tropical disease to receive a Priority Review 
Voucher (PRV) under FDA's Tropical Disease PRV Program. The following 
conditions must be met: (1) there is no significant market in developed 
nations for the particular disease; and (2) the disease 
disproportionately affects poor and marginalized populations. This 
authority is delegated to FDA.

    FDA has provided a process for requesting that additional diseases 
be added to the PRV list. The process involves the submission of a 
request to a special docket set up to facilitate the consideration of 
such requests; the request is accompanied by information to document 
that the disease meets the statutory criteria required to be added to 
the PRV list.\18\ FDA has not received a request to add the Zika virus 
to the PRV list via the docket. While the agency does not want to 
foreclose anyone from following that process and is fully prepared to 
evaluate any submissions that are made with respect to the Zika virus, 
it does not appear--based on the information currently available to 
FDA--that the Zika virus meets the criteria set out in the statute. 
While it appears likely that the Zika virus disproportionately affects 
poor and marginalized populations, it also appears that there is a 
significant market for Zika virus medical products in developed 
nations, which would render the Zika virus ineligible for addition to 
the PRV list under the statute at this time. There is a significant 
market in the United States, a developed nation, where there is active 
Zika transmission by mosquitoes in Puerto Rico, the U.S. Virgin 
Islands, and American Samoa, and a threat of local spread by mosquitoes 
in the continental United States--though likely more limited due to 
protective factors such as air conditioning and screened windows.
---------------------------------------------------------------------------
    \18\  See http://www.regulations.gov, Docket No. FDA-2008-N-0567.

    Question. I am concerned about the adequacy of our physician 
workforce and our ability to care for an aging population. I see that 
the administration proposed significant reductions in Medicare support 
for Graduate Medical Education (GME), with $18 billion cuts over the 
---------------------------------------------------------------------------
10-year budget window.

    According to the Association of American Medical Colleges, our 
Nation is facing a workforce shortage of between 46,000 and 90,000 
physicians by 2025, with shortages most acute in surgical specialties--
the result of a growing, aging population.

    Medical schools in Florida, and across the country, have increased 
enrollment, and teaching hospitals are expanding training to address 
the physician shortage. Medical schools and teaching hospitals are also 
working hard to ensure that new doctors coming into the system are well 
trained to serve in new delivery models--such as ACOs--that focus on 
care coordination and quality improvement.

    As a long-time supporter of GME, I believe we need to invest in 
physician training to ensure an adequate number of physicians are 
available to serve an aging population. I am concerned that these 
proposed cuts would undermine our ability to do that.

    With the projected physician shortages, why is the administration 
proposing these types of cuts to GME that would affect patient care, 
physician and workforce training, and research?

    Answer. HHS recognizes the importance of graduate medical 
education. Nonetheless, like any other category of Medicare spending, 
payments to teaching hospitals must be justified by incurred costs. 
This proposal will help graduate medical education programs promote 
high quality primary care services that address relevant public health 
needs by allowing the Secretary to target funding to training 
activities specific to issues. HHS believes this proposal brings these 
payments closer to the appropriate level and provides incentives for 
promoting high-quality primary care. In addition, the Teaching Health 
Center Graduate Medical Education (THCGME) Program provides funding for 
residency training in primary care medicine and dentistry in community-
based, ambulatory settings. The THCGME Program seeks to not only 
bolster the primary care workforce through support for new and expanded 
primary care and dental residency programs, but also improve the 
distribution of this workforce into needed areas through emphasis on 
underserved communities and populations. The FY 2017 budget includes 
$60 million in funding appropriated in MACRA, as an additional $527 
million over FYs 2018-2020 to support up to 876 residents and restore 
the per resident payment to $150,000.

    Question. I remain concerned about prescription opioid abuse and 
how this crisis may be contributing to heroin use in our Nation. 
According to the Centers for Disease Control and Prevention (CDC), 
there was a 16 percent increase in the number of prescription opioid 
deaths in 2013 and 2014. In total, there were 19,000 prescription 
opioid overdoses in 2014, as well as 10,000 heroin-related overdoses.

    Several ideas have been proposed to address these issues, such as 
establishing prescription drug monitoring programs or improving how 
these prescriptions drugs are prescribed. On November 9, 2015, I joined 
several of my Senate colleagues in sending a letter to the CDC urging 
the agency to release its final guidelines for opioid prescribing. When 
does the CDC plan to release these guidelines?

    Answer. Thank you for your question and for your November letter 
expressing your support for the CDC Guideline for Prescribing Opioids 
for Chronic Pain. We agree that too many lives have been damaged by the 
opioid abuse and misuse epidemic. More than 16,000 deaths are due to 
prescription opioid overdoses each year. The goal of our draft 
guideline is to improve the safety of prescribing opioids and to 
curtail the harms associated with them.

    The guideline is intended for primary care providers treating 
patients 18 years of age and older for chronic pain in outpatient 
settings. It is not intended for patients in active cancer treatment, 
palliative care, or end-of-life care. The guideline's recommendations 
will primarily focus on the use of opioids in treating chronic pain 
(i.e., pain lasting longer than 3 months or past the time of normal 
tissue healing) outside of end-of-life care. Improving the way opioids 
are prescribed through clinical practice guidelines allows patients 
access to safer, more effective chronic pain treatment while reducing 
the number of people who misuse, abuse, or overdose from these powerful 
drugs.

    Since November, CDC released the Guideline for a 30 day public 
comment period and received more than 4,300 comments. The Injury 
Center's Board of Scientific Counselors (BSC) met and established an 
Opioid Guidelines Workgroup to review the draft Guideline and provide 
observations. That workgroup provided its recommendations to the BSC. 
The BSC voted unanimously to support the observations made by the BSC 
Opioid Guideline Workgroup; recommend adoption of the guideline 
recommendations that had unanimous or majority support; and recommend 
that CDC further consider the guideline recommendations for which the 
workgroup had mixed opinions. CDC has taken the BSC's recommendations, 
as well as comments received from the public, into consideration and is 
reviewing all of the information to determine what revisions might be 
necessary. Once this process is complete, the guidelines shall be 
finalized and released to the public. We expect the release to occur in 
the Spring of 2016.\19\
---------------------------------------------------------------------------
    \19\ All responses are accurate as February 11, 2016.

                                 ______
                                 
               Questions Submitted by Hon. Mark R. Warner
    Question. Fully leveraging the potential of the Digital 
Accountability and Transparency (DATA) Act of 2014 presents a unique 
opportunity for agencies to facilitate better management and reduce the 
compliance burden on Federal grantees. The Department of Health and 
Human Services plays a critical leadership role as the executing agent 
for the Grants Pilot under section 5 of the Act, and I am pleased that 
the Department's $10.3 million request for DATA Act implementation 
reflects that role. To that end, please answer the following questions.

    The pilot is required to facilitate the development of 
recommendations for ``standardized reporting elements across the 
Federal Government, the elimination of unnecessary duplication in 
financial reporting, and the reduction of compliance costs for 
recipients of Federal awards.'' The pilot has the potential to 
fundamentally transform and improve the Federal grants reporting 
process for both agencies and grantees, beyond merely the consolidation 
of forms. Such a broad vision to improve data quality reflects the 
legislative intent of the law. Can HHS fully commit to this vision of 
the pilot program?

    Answer. HHS is fully committed to implementing the section 5 Grants 
Pilot to support the pilot's vision to improve efficiencies within the 
grants process which will benefit all Federal agencies and their 
respective grant recipients. In order to fulfill its responsibilities 
as the Office of Management and Budget's (OMB) executing agent of the 
Pilot, HHS is working in close collaboration with OMB. In May 2015, HHS 
launched a Common Data Elements Repository Library and has deployed a 
``Learn Grants'' tab on Grants.gov. HHS has also coordinated with OMB 
to launch a National Dialogue in May 2015 that provides opportunities 
for recipient engagement in discussions on compliance costs and burden 
reduction and in addition, HHS has been collecting recipient feedback 
with these tools and additional outreach, which it has used to create 
the pilot test models. HHS has also created a section 5 Grants Pilot 
Framework which outlines how the six Test Models, used to conduct the 
pilot tests, collect data, and create the final report to OMB and 
Congress.

    Question. As you begin the collection of pilot data this spring, 
both Congress and the Office of Management and Budget should provide 
appropriate support to the HHS DATA Act Program Management Office. What 
congressional assistance or oversight role would be most of use to the 
PMO? How can OMB facilitate these efforts? Would the support of other 
Federal entities, such as the U.S. Digital Service or 18F, be of use?

    Answer. Execution of the section 5 Grants Pilot has been arranged 
into a series of phases--each designed to inform subsequent phases 
within the interconnected pilot activities. The Federal Government is 
the target audience for early phases of the Pilot, while grant 
recipients (or public) are engaged in later phases. Data collection 
involves focus groups, participant feedback, user experience, and 
analytics. The section 5 Grants Pilot launch schedule and Test Model 
planned activities (subject to the OMB concurrence and resource 
availability) will largely occur in the data collection phase. The 
passage of requested funding in my FY 2017 budget in support of these 
efforts would be beneficial. HHS believes that the test models as 
designed will provide significant improvements within the grants 
lifecycle and organizations such as the U.S. Digital Service or 18F 
would likely be able to advance the path forward based on 
recommendations resulting from this Pilot work.

    Question. With fully electronic grant reporting, as tested by the 
pilot, data fields in grantee forms that are standardized across the 
Federal Government would enable grantee software to generate reports 
automatically. Do you believe that focusing on data fields, rather than 
the forms containing them; can help to reduce grantee compliance costs?

    Answer. Under the PRA, burden is calculated based on the aggregate 
of elements required for reporting by the grantee versus individual 
data elements. However, by standardizing individual data elements, it 
could enable data elements to be automatically populated for the 
grantee, which would reduce burden for the required sets of data 
elements (forms) that grantees must report.

    Question. HHS provides grants to a wide range of recipients in a 
variety of fields. Under the pilot, the PMO has compiled the Central 
Data Element Repository Library, or CDER-L; does HHS plan to use the 
CDER-L data fields across its own grant reporting regardless of their 
adoption on a government wide basis?

    Answer. The Common Data Element Repository (CDER) Library is 
designed to be a repository for standards to facilitate consistency of 
Federal terminology for financial assistance terms and definitions for 
purposes of the Pilot. Through the Pilot, the CDER Library will be 
tested for its utility to reduce recipient burden with the goal of 
better managing or reducing forms necessary for information 
collections. Furthermore, HHS will be working with grant recipients to 
determine if this tool will help them in completing forms by using a 
single reference tool to ensure there is a solid understanding of the 
terminology which should result in more accurate information being 
provided and increase the speed in which that information can be 
provided. HHS will be gathering feedback on whether it is easy to for 
standard terminology provided and to identify duplicative use of 
information across financial assistance forms. HHS would need 
todetermine the sustainability and associated ownership costs to better 
determine the potential long-term uses of this tool. Based on the 
feedback to date from the private sector, other government agencies, 
and counsels, such as Council of Agency Officials for Paper Work 
Reduction, this appears to be a solid investment.

    Question. What elements of the DATA Act Grants Pilot Framework does 
the Department view as most promising for scaling up on a government 
wide basis, and to informing the changes needed to meet the DATA Act's 
reporting requirements? Which elements have been most challenging to 
implement, to date, or would be most challenging to implement on a 
government wide basis?

    Answer. The section 5 Grants Pilot framework takes a holistic 
approach to meeting the section 5 Pilot goals. HHS will integrate the 
components of the framework and collect grant recipient feedback 
through the National Dialogue tool and the Test Models. The Test Models 
will focus on five areas: the CDER Library, Consolidated Federal 
Financial Report (Consolidated FFR), Single Audit, Notice of Award, and 
Learn Grants. The Test Models will use existing technologies and tools 
during execution. The execution of each Test Model aligns with the 
requirement to conclude the pilot by May 2017. HHS will analyze the 
data collected during the pilot period and make recommendation based on 
an analysis of the data collected during the pilot testing phase. As 
the test models are still pending Paperwork Reduction Act clearance, it 
would be premature to make any determinations related to challenges 
surrounding implementation, but HHS views this as a promising approach 
given the preliminary feedback during our pre-test meeting with 
representatives from the grant recipients' community.

                                 ______
                                 
            Questions Submitted by Hon. Robert P. Casey, Jr.
    Question. The Department of Health and Human Services (HHS) is to 
be congratulated for publishing the 2015-2020 Dietary Guidelines for 
Americans, which are important to help guide Americans towards eating a 
healthier diet. However, there are specific vulnerable populations--
such as older adults, particularly those with chronic disease--who may 
have critical nutrition needs that are not addressed by these general 
population guidelines. Indeed, malnutrition has been identified as a 
new senior crisis which should be reflected in national health goals.

    How is HHS addressing the issue of older adult malnutrition as a 
public health crisis?

    Answer. Adequate and nutritionally balanced food is vitally 
important for promoting health, decreasing the risk of chronic disease, 
maintaining functionality, and helping older adults remain independent 
at home in their communities.

    The Administration for Community Living (ACL) manages the Older 
Americans Act (OAA) nutrition services programs which have been a core 
element of our national strategy for reducing food insecurity and 
delaying or avoiding adverse health conditions, including malnutrition, 
among older adults for over 40 years. The OAA requires that Meals on 
Wheels meals meet nutritional and safety standards. These community-
based programs, which serve persons aged 60 and over, provide access to 
meals in a group setting or delivered to the home, a service that is 
not provided by other Federal nutrition programs. In addition to 
providing access to nutritious meals, ACL's nutrition programs also 
provide nutrition education, counseling, and opportunities for 
socialization. Although the majority of the older adults who 
participate in these programs have low incomes, income alone is not an 
adequate measure of the need for nutritious food. For the majority of 
program participants, these meals provide more than one-half of their 
daily food intake.

    The President's budget request for OAA nutrition services is $13.8 
million above the FY 2016 enacted level. At this level, the budget 
request, combined with State and local contributions, would support an 
estimated 205 million home-delivered and congregate meals to more than 
2.2 million elderly individuals in a variety of community settings. 
While investments in nutrition services are clearly needed, it is also 
critical that we work with State and local partners to modernize these 
services and ensure that every dollar is spent effectively. Providing 
nutrition services improves the health of participants and reduces 
their need for more expensive medical interventions and institutional 
care. Translating research into evidence-based models for delivering 
services at the community level is important to ensuring the continued 
effectiveness of these programs. To that end, the FY 2017 budget would 
also allow for up to 1 percent of the appropriations provided for 
nutrition to be invested in evidence-based innovation projects, 
including efforts to address malnutrition.

    Question. What plans are there to include it in national public 
health goals such as updates to Healthy People 2020?

    Answer. HHS supports the inclusion of reducing older adult 
malnutrition as a national public health goal in the updates to Healthy 
People 2020 (HP2020). The work on HP2020 is winding down and the 
establishment of new and updated goals for HP2030 will soon start, so 
the timing is good for bringing needed attention to these issues.

                                 ______
                                 
             Questions Submitted by Hon. Michael F. Bennet
                      raise family caregivers act
    Question. Senators Ayotte and I lead the ACT Caucus here in the 
Senate. It represents the 42 million family caregivers in this country 
who sacrifice their time and energy to care for a loved one. We 
recently passed the RAISE Family Caregivers Act in the Senate to direct 
HHS to develop a National Family Caregiving Strategy.

    While we wait for the House to act, are there areas of this bill 
that HHS could start implementing today? Is this something you can 
prioritize this year?

    Answer. First, I would like to commend you and Senator Ayotte for 
your leadership and the Senate's efforts to support our Nation's family 
caregivers. The vast majority of long-term care support in the U.S. is 
provided by family, friends, and neighbors--almost 18 million Americans 
provide care for a chronically ill, disabled, or an aged family member 
or friend during any given year. We are committed to helping them meet 
the challenges of caregiving by identifying and expanding evidence-
based practices which better enable them to help take care of their 
loved ones.

    The FY17 budget requests increases for programs at ACL that support 
essential services for family and informal caregivers and improve 
quality of and access to respite care. Eighty percent of the caregivers 
served by OAA programs report that these services allow them to provide 
care longer than they otherwise could.

    Caregivers may also benefit from the home- and community-based 
services provided through ACL, such as nutrition programs, and through 
Medicaid. These can offer additional help that can make a difference in 
being able to keep a loved one at home and include:

          CMS has taken steps to enhance the quality of home and 
        community-based services, provide additional protections to 
        individuals that receive services under these Medicaid 
        authorities, and provide States with additional options to 
        expand home and community-based services and target services to 
        specific populations. States may choose to provide services 
        such as respite care, which can relieve caregivers of their 
        responsibilities for time periods of up to several days, or 
        services to care for beneficiaries during the day, such as 
        adult day health care services, enabling caregivers to maintain 
        employment. There are a number of additional services available 
        at State option that provide relief for the caregiver as well 
        as the individual requiring services and supports. CMS is 
        available to provide technical assistance to incorporate these 
        services into Medicaid programs.

          The National Family Caregiver Support Program was created 
        with the 2000 reauthorization of the OAA. It provides each 
        State and territory with formula grants to establish a base of 
        supports for family caregivers consisting of information, 
        assistance, counseling, training and support groups, respite, 
        and supplemental services, on a limited basis.

          The Alzheimer's Disease Supportive Services and the 
        Alzheimer's Disease Initiative Supportive Services programs 
        both work to advance capacities to meet the complex needs of 
        family caregivers of persons with Alzheimer's disease and 
        related dementias at State and local levels by enhancing the 
        dementia-capability of the systems and programs that serve 
        them.

          The Lifespan Respite Care Program provides funding to States 
        to enable them to develop and strengthen respite services for 
        family caregivers of persons with disabilities of all ages. 
        Under this program, States work with statewide respite 
        coalitions and in consultation with aging and disability 
        resource centers to create systems of accessible and high 
        quality respite services.

    Providing support that makes caregiving easier for family 
caregivers, such as information, counseling and training, respite care, 
or supplemental services, is critical to sustaining caregivers' ability 
to continue in that role. 80 percent of caregivers served by OAA 
programs report that these services allow them to provide care longer 
than they otherwise could.

    Question. In Colorado, we've seen huge price variations in what 
providers charge for services. In Eagle County, located in the mountain 
regions of Colorado, a person has a choice to have a knee surgery for 
$20,000 locally or in Denver for $6,000. In Lafayette, a knee 
replacement costs nearly $20,000, while the same procedure in Greeley 
costs $60,000. What can we do to address this kind of price variation?

    Answer. Researchers have conducted various studies on the 
geographic variation in hospital pricing. While Medicare pays hospitals 
pursuant to a formula set by statute, hospitals negotiate prices with 
commercial payers, which leads to variation in payment. Medicare is 
promoting more value in our health care system by paying providers on 
an episode basis such as through the Comprehensive Joint Replacement 
model, or holding them accountable to the costs and quality of care, 
such as through hospital participation accountable care organizations. 
In this way, we can encourage smarter spending and better care.

    Creating more transparency in price and quality is also important. 
Through Medicare, we regularly post information on provider charges. I 
look forward to working with you on further addressing this issue.

                                 ______
                                 
                Questions Submitted by Hon. Daniel Coats
    Question. The Medicare Competitive Bidding Program (CBP) has 
successfully reduced the amount Medicare spends on Durable Medical 
Equipment (DME), including diabetic testing supplies (DTS). However, a 
recent study (``CMS Competitive Bidding Program Disrupted Access to 
Diabetes Supplies with Resultant Increased Mortality,'' American 
Diabetes Association 75th Scientific Sessions, 5-7 June 2015, Boston, 
MA) reported that Medicare beneficiary testing compliance decreased, 
and that drop-off coincided with a higher number of deaths and 
hospitalizations among persons with diabetes. More recently, a November 
2015 report by the National Minority Quality Forum titled ``Centers for 
Medicare and Medicaid Services Competitive Bidding Program: Assessment 
of Impact on Beneficiary Acquisition of Diabetes Testing Supplies/and 
DMEPOS Associated Health Outcomes'' found that the CMS data supporting 
patient access claims was flawed. Have you reviewed these studies?

    Please provide evidence that Medicare beneficiaries will not suffer 
further disruptions in access to DTS or deterioration of health 
outcomes as a result of the CBP for diabetes testing supplies.

    Answer. The Durable Medicare Equipment, Prosthetics, Orthotics and 
Supplies (DMEPOS) competitive bidding program is an essential tool to 
help Medicare set appropriate payment rates for DMEPOS items by 
replacing the existing, outdated, excessive fee schedule amounts with 
market-based prices. The program has resulted in reducing beneficiary 
out-of-pocket costs, providing significant savings to the Medicare 
program and taxpayers, and reducing over-utilization and fraud. 
Additionally the program has ensured continued beneficiary access to 
high quality items and services without compromising beneficiary health 
and safety.

    CMS has reviewed the National Minority Quality Forum (NMQF) 
abstract with great interest, and we look forward to viewing the peer 
reviewed published study so we can better understand the methods 
leading to their conclusions. We take seriously any beneficiary access 
or health outcomes concerns, and that is the primary reason CMS has 
implemented a robust monitoring program to track and resolve any issues 
that might occur with DMEPOS competitive bidding program 
implementation. To the extent an issue arises, CMS will act promptly to 
address it.

    Our extensive real-time monitoring results differ from the 
conclusions of the study. Our monitoring identified no changes in 
health outcomes, including death, hospitalization and emergency 
department visits. In addition, we have found that prior to the DMEPOS 
competitive bidding program, it appears that some past mail-order 
suppliers routinely shipped diabetic testing supplies to beneficiaries 
every 90-days, regardless of need. We also note that there have been 
high improper payment rates and evidence of fraud and overutilization 
in the Medicare DME area, which CMS and Office of Inspector General 
have continued to address.

    Question. I'd like some more information on the coverage decision 
process at CMS. Specifically, can you please tell me how many requests, 
both internally at CMS and by outside stakeholders, for a National 
Coverage Decision (NCD) were made in 2015? Of those requests, how many 
were approved for review by CMS? How many NCDs were ultimately issued 
in 2015?

    Answer. Each year, as required by statute, CMS reports to Congress 
on the Medicare National Coverage Determinations (NCDs) implemented in 
the prior fiscal year. On February 3, 2016, CMS delivered its report 
for FY 2015 detailing the completion of five NCDs. Further detailed 
information on each NCD is available in the coverage indexes on CMS's 
website at https://www.cms.gov/medicare-coverage-database/indexes/
national-and-local-indexes.aspx, including a ``tracking sheet'' with 
links to the requestor's letter, proposed and final decision memoranda, 
public comments received when the NCD review was first initiated and in 
response to the proposed decision, and any other information relevant 
to the analysis of evidence that led to the NCD. Additional information 
on the coverage process is available on the ``Medicare Coverage 
Center'' website at https://www.cms.gov/Center/Special-Topic/Medicare-
Coverage-Center.html.

    Question. Additionally, has the coverage group identified the 
National Coverage Decisions it plans to conduct in FY 2017? If yes, 
what are they and how were they selected?

    Answer. CMS receives and considers requests for National Coverage 
Analyses (NCAs)--the first step in the NCD process--on an on-going 
basis. Once a request is determined to include the necessary 
information and supporting evidence needed for an NCA, the opening of 
the NCA is posted on the CMS website at https://www.cms.gov/medicare-
coverage-database/indexes/national-and-local-indexes.aspx, and is open 
to a 30 day public comment period, prior to development of a proposed 
coverage decision. Public comments are again invited when a proposed 
decision is issued, to help inform the development of a final NCD.

                                 ______
                                 

                                                                  INDIAN HEALTH SERVICE
                                                                No-Year Budget Authority
                                                    History of Unobligated Balances FY 2010--FY 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
             SERVICES--75  0390  Programs                  FY 2010         FY 2011         FY 2012         FY 2013          FY 2014          FY 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
Catastrophic Health Care                                       272,734       5,514,880         644,797       3,274,461         8,677,527      11,607,454
--------------------------------------------------------------------------------------------------------------------------------------------------------
Federal Medical Care Recovery Act                              592,390         614,213         766,279         570,312           729,491         700,274
--------------------------------------------------------------------------------------------------------------------------------------------------------
Domestic Violence Prevention Initiative                      7,436,629      12,279,341      17,006,209      13,511,120        13,802,681      11,435,589
--------------------------------------------------------------------------------------------------------------------------------------------------------
Indian Self-Determination                                       12,802          12,802          13,633          13,633            12,802          12,802
--------------------------------------------------------------------------------------------------------------------------------------------------------
Private Insurance Collections                               23,829,208      36,131,208      50,963,367      60,816,737        58,277,392      72,099,025
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medicare                                                    20,524,558      35,875,591      62,154,819      66,570,104        76,071,359      96,486,270
--------------------------------------------------------------------------------------------------------------------------------------------------------
EHR Incentives--Medicare                                                                            --       1,380,400         6,151,690       6,203,724
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medicaid                                                    44,296,964     109,267,945     165,129,546     197,706,432       216,119,796     264,016,198
--------------------------------------------------------------------------------------------------------------------------------------------------------
EHR Incentives--Medicaid                                                                        27,018      12,586,901        16,538,583      13,661,404
--------------------------------------------------------------------------------------------------------------------------------------------------------
IHS and VA Dual-Eligible Beneficiaries                                                                                           248,016       4,854,262
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diabetes                                                    44,161,096      29,209,247      44,703,803      46,261,076        48,737,462      50,472,501
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alcohol and Substance Abuse/Meth Prevention                  5,016,524       6,165,464      20,071,390      11,040,452        11,522,922       5,542,027
--------------------------------------------------------------------------------------------------------------------------------------------------------
Office for Victims of Crime (OVC) Reimbursement                                     --          85,000              --                --         254,016
--------------------------------------------------------------------------------------------------------------------------------------------------------
CHIPRA of 2009 Pub. L. 111-3                                                        --         418,457         163,318           101,548         101,548
--------------------------------------------------------------------------------------------------------------------------------------------------------
Buybacks                                                   134,972,002     107,950,426      62,388,999      68,844,691        58,563,030      51,929,889
--------------------------------------------------------------------------------------------------------------------------------------------------------
Crime Victim Equipment-Interagency Agreement with              162,558         514,936         500,036         420,273           328,968         114,587
 Department of Justice
--------------------------------------------------------------------------------------------------------------------------------------------------------
PRC Services--PY for California and Tucson Only                 39,210          39,210          39,210          39,210
--------------------------------------------------------------------------------------------------------------------------------------------------------
Indian Health Professions--Scholarship                       2,938,833       3,016,883      18,033,667      21,662,389         8,742,951       7,369,101
--------------------------------------------------------------------------------------------------------------------------------------------------------
Indian Health Professions--Loan Repayment                    1,849,145       1,968,942      13,582,469       7,315,123         8,032,928       1,146,905
--------------------------------------------------------------------------------------------------------------------------------------------------------
Purchased/Referred Care                                     55,439,426      80,106,327      43,162,641      48,272,657        43,753,885      70,007,963
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Services TOTAL                                         341,544,079     428,667,415     499,691,340     560,449,289       576,413,031     668,015,539
--------------------------------------------------------------------------------------------------------------------------------------------------------



--------------------------------------------------------------------------------------------------------------------------------------------------------
            FACILITIES--75  0391  Programs                 FY 2010         FY 2011         FY 2012         FY 2013          FY 2014          FY 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance and Improvement                                 46,485,826      54,347,347      57,607,439      49,616,278        48,300,125      46,114,304
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sanitation                                                   5,028,069       1,292,291       1,409,469       1,353,026         5,307,821       2,007,803
--------------------------------------------------------------------------------------------------------------------------------------------------------
Health Care Facilities Construction                         42,378,338      28,624,623      15,848,006      17,324,786         6,742,024      27,315,506
--------------------------------------------------------------------------------------------------------------------------------------------------------
Facilities and Environmental Health Support                 47,058,255      58,615,163      62,997,381      62,523,351        57,439,429      62,710,182
--------------------------------------------------------------------------------------------------------------------------------------------------------
Equipment                                                   21,522,272      22,941,083      25,597,070      21,349,923        22,080,753      19,675,038
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reimbursements                                              16,310,851       8,561,376      27,225,378       4,805,757         4,123,899       3,600,591
--------------------------------------------------------------------------------------------------------------------------------------------------------
Balancing Adjustments and Miscellaneous Budget                                               (795,619)          26,823            28,357          28,358
 Activity Programs
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Facilities TOTAL                                       178,783,611     174,381,883     189,889,124     156,999,944       144,022,408     161,451,782
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                 ______
                                 

                Awards Guidance on Spending Limitations

The Office of Personnel Management (OPM) and the Office of Management 
and Budget (OMB) are issuing this awards guidance that applies to 
awards paid during the Fiscal Year (FY) (e.g., FY15 is October 1, 2014, 
through September 30, 2015) and shall continue to remain in effect 
until further notice. This guidance is applicable to all departments 
and agencies (referred to collectively as agencies).

Budgetary Limitations for Individual Monetary Awards

These budgetary limits apply to agency spending for individual monetary 
awards only, which include rating-based performance awards and 
individual contribution (e.g., special act) awards.

Agencies must limit total awards spending on the following categories 
of awards:

      Agencies may spend no more than 4.8 percent of the aggregate 
salaries of their career executives at the end of the previous fiscal 
year on individual performance awards for career members of the Senior 
Executive Service (SES).

      Agencies may spend no more than 4.8 percent of the aggregate 
salaries * of their senior-level and scientific and professional 
employees (SL/ST) at the end of the previous fiscal year on individual 
performance awards for SL/ST employees.
---------------------------------------------------------------------------
    * These budgetary limitations do not apply to political appointees. 
Therefore, the salaries of political appointees are not included when 
calculating the awards funding. The President's August 3, 2010, 
memorandum freezing discretionary awards, bonuses, and similar payments 
for political appointees continues in effect until further notice. 
Agencies should continue to apply this freeze in accordance with OPM's 
guidance at http://www.chcoc.gov/Transmittals/
TransmittalDetails.aspx?TransmittaliD=3060.

      Agencies may spend no more than 0.96 percent of the aggregate 
salaries * of all employees at the end of the previous fiscal year on 
the combination of (1) individual performance awards for non-SES/SL/ST 
employees, and (2) individual contribution awards (e.g., special act 
---------------------------------------------------------------------------
awards) for all employees (i.e., SES/SL/ST and non-SES/SL/ST).

OPM and OMB will continue to monitor awards data that agencies provide 
to OPM under the agencies' regular reporting procedures for compliance 
with these limitations.

In addition, if overall Government-wide discretionary funding levels 
are reduced below the discretionary spending caps set forth in the 
Budget Control Act (the BCA) of 2011 (Public Law 112-25), each agency 
shall further reduce awards spending pools for SES and non-SES by an 
amount proportional to the Governmentwide reduction made from the 
original BCA discretionary spending cap, as determined and communicated 
by OMB.

Other Covered Awards

Consistent with previous awards guidance, the limitations on the 
following remain unchanged:

      Other awards and incentives, such as group awards, referral 
bonuses, or suggestion/invention awards, are frozen at FY 2010 spending 
levels. Travel savings and foreign language awards are not frozen.

      Time-off awards are not direct monetary expenditures and are not 
included in the 0.96 percent limit; however, agencies should continue 
to use time-off awards judiciously as they do represent a cost to the 
agency.

      Recruitment, relocation, and retention incentives are not awards 
and are not covered by the budgetary limits; however, agencies should 
ensure that spending on these incentives in the aggregate during the 
calendar year does not exceed calendar year 2010 levels.

      Quality step increases for General Schedule employees is another 
category of rating-based payment that does not constitute an award. 
These payments are not covered by the 0.96 percent budgetary limit; 
however, agencies may not exceed their FY 2010 spending levels on 
quality step increases granted during the fiscal year.

These budgetary limits apply to all Executive branch agencies for all 
members of the SES as well as non-SES civilian employees, including SL/
ST, General Schedule, wage grade and others, except political 
appointees covered by the freeze on discretionary spending. Agencies 
retain the flexibility, however, to apply these budgetary limits on 
awards programs to all employees, regardless of applicable pay 
authority, to accommodate current budget constraints, provided they 
meet all legal requirements and agency contractual obligations.

In applying these budget limitations, agencies should discuss their 
agency award programs in agency labor-management forums and should 
honor all collective bargaining obligations and existing agreements 
prior to implementation.

Additional Information

Agency Chief Human Capital Officers and/or Human Resources Directors 
should contact Stephen T. Shih, Deputy Associate Director for Senior 
Executive Services and Performance Management, in OPM's Employee 
Services, at (202) 606-8046 or [email protected] if they 
have any questions regarding this guidance. Employees should contact 
their agency human resources offices for assistance.

Agencies that did not spend anything in 2010 on the types of awards/
payments limited to 2010 spending should contact their Resources 
Management Officer at OMB to establish appropriate baseline spending 
amounts.

                                 ______
                                 

   DEPARTMENT OF HEALTH AND HUMAN SERVICES            OFFICE OF THE 
                               SECRETARY

_______________________________________________________________________
                             Assistant Secretary for Administration
                                          Office of Human Resources
                         Workforce Management and Vitality Division

                           November 18, 2014

MEMORANDUM FOR--SEE DISTRIBUTION

SUBJECT:  Supplemental Guidance on Awards for Non-Senior Executive 
Service (SES)/Senior Level and Scientific and Professional Employees 
Fiscal Year 2015

December 31, 2014 marks the end of the calendar year (CY) 2014 
Performance Management Appraisal Program (PMAP) Cycle for non-Senior 
Executive Service (SES)/Senior Level and Scientific and Professional 
employees. The attached guidance is provided to assist supervisors and 
managers with the closeout and awards process. All CY 2014 PMAP 
closeouts must be completed no later than February 17, 2015. Once your 
closeout has been completed, we ask that you submit your compliance 
with this requirement to [email protected]. PMAP policy information is 
available on the HHS intranet at (http://intranet.hhs.gov/hr/ohr/pmap/
policy.html).

On November 1, 2013, the Office of Management and Budget (OMB) and the 
Office of Personnel Management (OPM) issued a memorandum superseding 
their FY 2013 memoranda, which placed a moratorium on awards while 
under sequester. On January 8, 2014, the Department issued additional 
guidance on this matter. On February 27, 2014, the Department issued 
OMB guidance on revised performance awards spending caps. OMB's 
calculation results in a new cap of 0.96 percent for all employees for 
spending on non-SES/SUST performance awards and individual contribution 
awards. The previous cap of 1 percent is no longer in effect, and has 
been replaced by the lower cap.

As a result, the attached Awards Guidance is consistent with the 
previously-issued Guidance on Awards for Fiscal Year 2014 (M-14-02), 
with the following exceptions (1) the Guidance incorporates the reduced 
aggregate spending percentage caps (as reduced by the Budget Control 
Act and communicated to the CHCO community in February 2014) (2) the 
Guidance on Awards for Fiscal Year 2014 included a requirement stating 
``agencies may not exceed FY 2012 spending levels on either category of 
awards.'' This limitation is removed and agencies are expected to 
adhere only to the budgetary percentage limitations in the Awards 
Guidance.

Taken together, the OMB, OPM, and departmental supplemental guidance on 
discretionary awards, including awards in performance systems 
established by, or managed under, HHS authority is attached, along with 
the OPM and OMB memorandum.

Please ensure that all collective bargaining obligations are met prior 
to implementing any provisions contained herein. My point of contact 
for this matter is Mr. Nicholas Troilo and Mr. Zachasias Russell. You 
may contact Nicholas Troilo at [email protected] or (202) 725-
8872. Mr. Zachasias Russell may be contacted at 
[email protected] or (202) 619-0125

            Darrell R. Hoffman, SPHR
            Director, Workforce Management and Vitality

    Attachments:
    -  OPM and OMB Joint Guidance on Awards for Fiscal Year 2015, 
issued November 14, 2014
    -  OPM and OMB Joint Guidance on Awards for Fiscal Year 2014, dated 
November 1, 2013; OMB Guidance on Revised Performance Awards Spending 
Caps issued February 27, 2014 to HHS HR Directors and HR Deputies
    - Guidance on Awards for Fiscal Years 2011 and 2012, dated June 10, 
2011

                                 ______
                                 

Guidance on Awards for Non-SES/ST/SL Employees Fiscal Year 2015

1. References:

    a.  Continuance of Office of Personnel Management (OPM) and Office 
of Management and Budget (OMB) memorandum, Subject: Guidance on Awards 
for Fiscal Year 2014 (M-14-02), issued November 14, 2014; OPM and OMB 
Joint Guidance on Awards for Fiscal Year 2014, dated November 1, 2013; 
to include Departmental guidance dated January 8, 2014 and OMB Guidance 
on Revised Performance Awards Spending Caps issued February 27, 2014 to 
HHS HR Directors and HR Deputies.

    b.  Office of Personnel Management memorandum, Subject: Guidance on 
Awards for Fiscal Years 2011 and 2012, dated June 10, 2011.

2. In reference 1a above, OPM and OMB established that agencies must 
reduce performance award and individual contribution awards spending 
for all Non-Senior Executive Service (SES)/Senior Level and Scientific 
and Professional employees to no more than 0.96 percent of their 
aggregate salaries.\1\ Further, these award-spending targets apply for 
awards with effective dates during Fiscal Year 2014 and 2015. 
Accordingly, this memorandum provides the Department of Health and 
Human Services (HHS) guidance for individual awards in which include 
rating-based awards and individual special act awards for FYs 2014 and 
2015 and other categories as specified in the aforementioned guidance. 
This guidance is applicable to all non-
Senior Executive Service (SES)/Senior Level and Scientific and 
Professional civilian employees, including General Schedule, wage grade 
and others, except political appointees covered by the freeze on 
discretionary spending.
---------------------------------------------------------------------------
    \1\ Amounts budgeted for, or paid to, employees as recruitment, 
relocation, or retention incentives or the use of non-monetary rewards 
(to recognize performance and contributions to mission) are not 
included in the definition of an ``award'' and, thus, are not subject 
to the OPM/OMB awards limitation. Spending on these incentives in FY 
2015 can't exceed FY 2010 spending levels. (See Use of Non-Monetary 
Awards, pg. 4.)

The Office of Personnel Management, reference 1b, this memorandum 
provides the Department of Health and Human Services (HHS) guidance 
that placed aggregate spending caps on agency award spending for FYs 
2011 and 2012; agencies must limit award spending to no more than one 
(1) percent of total aggregate salaries for non SES performance awards 
plus individual contribution awards (e.g., special act, or spot) for 
all employees. The above referenced 1a supersedes the June 2011 
guidance that placed aggregate spending caps on agency award spending 
for FYs 2011 and 2012 to no more than one percent of total aggregate 
salaries for non-SES/SL/ST performance awards plus individual 
---------------------------------------------------------------------------
contribution awards (e.g., special act, or spot) for all employees.

3. It should be noted that reference 1a acknowledges that though agency 
executives retain flexibility, ``it is critical that agencies' use of 
performance awards be managed in a manner that is cost-effective and 
leads to increased employee performance and organizational results,'' 
you are expected to meet all legal requirements and agency contractual 
obligations to include collective bargaining obligations.

4. The recently revised OPM/OMB guidance requires that for FY 2014, 
agencies must reduce spending on performance awards and individual 
contributions awards for all employees to no more than .96 percent of 
aggregate base salary (base salary rate plus locality adjustment). This 
guidance is still in effect for FY 2015.

5. This policy guidance neither limits the sum of monetary performance 
award to a particular employee nor the percentage of employees 
receiving awards. A reduction in current award spending levels may be 
required to achieve the mandated cap of .96 percent in FYs 2014 and 
2015. Performance awards are discretionary and are based on the 
employee's rating of record. In this challenging economic environment, 
we must continue to maintain the high performance of our civilian 
workforce and recognize excellence; it is imperative that management 
officials fully utilize our awards system to fairly and meaningfully 
recognize our employees. There should be equitable distribution of 
awards between manager/supervisors and non-supervisory employees.

6. A quality step increase (QSI) may also be granted to a GS employee 
based on his/her rating of record. The quality step increase for a GS 
employee is another category of rating-based payment that does not 
constitute an award under this guidance. These payments are not covered 
by the .96 percent budgetary limit. However, when determining the 
previous QSI spending level, keep in mind agencies may not exceed their 
FY 2010 spending levels on quality step increases granted during FY 
2011, FY 2012, FY 2013, FY 2014 and, FY 2015. In other words, each 
location (OPDIV/STAFFDIV) award amount cannot exceed the CY 2010 dollar 
amount for the entire FY 2015 they gave in FY 2010. Agencies should be 
cautious in awarding these payments until final funding levels for FY 
2015 are determined.

Note: QSIs dollar amount is the difference in pay between the two 
steps.

OPDIV/STAFFDIV Heads and rating officials must continue to exercise due 
diligence in maintaining the integrity of the awards systems. A QSI 
should only be approved for employees who have demonstrated exceptional 
accomplishments that are expected to continue and warrant an ongoing 
increase in pay. OPDIV/STAFFDIV Heads should ensure that these awards 
are not used to circumvent the .96 percent limitation, and are expected 
to monitor awards nominations for anomalies. These payments must be 
managed carefully as they create ongoing financial obligations for the 
Department.

7. Non-Senior Executive Service/Senior Level and Scientific and 
Professional GS employees provide invaluable contributions to the 
Department mission. The goal of the Department Awards program is to 
foster mission accomplishment by recognizing excellence. OPDIV/STAFFDIV 
Heads are encouraged to consider the full range of the department 
incentive awards program, which includes honorary awards, time-off-
awards, etc., to recognize performance excellence.

8. HHS organizations must ensure all collective bargaining obligations 
are fulfilled prior to implementing any provisions of this guidance.

Applicability

For purposes of equity and fairness in their application, restrictions 
on discretionary monetary awards prescribed by OPM/OMB \2\ will apply 
to all performance awards programs in HHS with limited exceptions. The 
budgetary limits specified in this memorandum apply to spending for 
individual monetary awards only, which include rating-based performance 
awards and individual special act awards.
---------------------------------------------------------------------------
    \2\ The budgetary limits in this memorandum apply to all executive 
branch agencies for all members of the non-SES civilian employees. 
Agencies retain the flexibility, however, to apply these budgetary 
limits to awards programs for their employees to accommodate current 
budget constraints, provided that those flexibilities meet all legal 
requirements and agency contractual obligations

These restrictions include but are not limited to organizations whose 
employees are covered by provisions of title 5 United States Code 
(U.S.C.) and title 5 of the Code of Federal Regulations (CFR), 
regardless of the source of their funding.

Use of Non-Monetary Awards

A well-managed recognition program provides managers non-monetary 
options to recognize performance and contributions to the mission. 
Managers are strongly encouraged to make full use of the many honorary 
awards available throughout the Department to recognize and reward hard 
work. Recognition in any form should be done publicly to maximize 
awareness that good performance and solid contributions will be 
recognized.

Other awards and incentives, such as group awards, referral bonuses, or 
suggestion/invention awards, are frozen at FY 2010 spending levels, 
except travel savings and foreign language awards. Time-off awards \3\ 
are not direct monetary expenditures and are not included in the .96 
percent limit; however, agencies should continue to use time-off awards 
judiciously as they do represent a cost to the agency.
---------------------------------------------------------------------------
    \3\ Time-Off awards: Agencies are encouraged to leverage existing 
award programs to reward employees who identify improvements that 
result in documented, validated cost savings and productivity 
improvements. An emphasis on awards of this nature is particularly 
important in light of the fiscal challenges the Federal Government is 
currently experiencing.

The ``3 Rs''--recruitment, relocation and retention incentives are not 
awards and are not covered by the budgetary limits. At the same time, 
the memo states, ``spending on these incentives in calendar years 2014, 
---------------------------------------------------------------------------
or 2015 does not exceed calendar year 2010 levels.''

As stated in the OPM/OMB guidance, time-off awards are permitted. When 
granting time-off awards, management should remember that time-off 
awards:

      Cannot exceed 80 hours in one leave year or 40 hours for a 
single contribution (adjusted applicably for part-time employees).

      Cannot be converted to cash payment under any circumstances.

      May not be transferred to gaining Agencies.

Labor Relations

All collective bargaining obligations must be met prior to implementing 
the provisions of either OMB or this supplemental guidance. Collective 
bargaining agreements or past practices may provide for a structure and 
minimum award amounts or percentages based on the ratings received by 
employees. Management must reach agreement with the union prior to 
implementing a change to an agreement or past practice. Management 
cannot unilaterally change the agreement or practice based on the 
prescribed limitations.

DISTRIBUTION: OPDIVS/STAFFDIVS Covered by this Guidance

    ASA          Assistant Secretary for Administration
                  - EEO Compliance and Operations (EEOC)
                  - Office of Business Management and Transformation 
(OBMT)
                  - Office of Security and Strategic Information (OSSI)
                  - Office of Human Resources (OHR)
                  - Office of the Chief Information Officer (OCIO)
                  - Program Support Center (PSC)
    ASA IO       - Immediate Office of the Secretary
    ACF          - Administration for Children and Families *
    ACL          - Administration for Community Living *
    AHRQ        - Agency for Healthcare Research and Quality *
    ASFR         - Assistant Secretary for Financial Resources
    ASH          - Office of the Assistant Secretary for Health
    ASL          - Assistant Secretary for Legislation
    ASPA         - Assistant Secretary for Public Affairs
    ASPE         - Assistant Secretary for Planning and Evaluation
    ASPR         - Assistant Secretary for Preparedness and Response
    CDC          - Centers for Disease Control and Prevention **
    CFBNP       - Center for Faith-Based and Neighborhood Partnerships
    CMS          - Centers for Medicare and Medicaid Services **
    DAB          - Departmental Appeals Board
    FDA          - Food and Drug Administration **
    HRSA         - Health Resources and Services Administration **
    IEA           - Intergovernmental and External Affairs
    IHS           - Indian Health Service **
    NIH           - National Institutes of Health **
    OCR          - Office of Civil Rights
    OGA          - Office of Global Health Affairs
    OGC          - Office of General Counsel
    OHCR         - Office of Healthcare Reform
    OIG           - Office of Inspector General **
    ONC          -  Office of National Coordinator for Health 
Information Technology
    OMHA        - Office of Medicare Hearings and Appeals
    SAMHSA      - Substance Abuse and Mental Health Services 
Administration *

    (*)            -  OPDIVS serviced by National Capital Region Human 
Resources Center
    (**)           -  OPDIVS serviced by independent HHS Human 
Resources Center

                                 ______
                                 
              Prepared Statement of Hon. Orrin G. Hatch, 
                        a U.S. Senator From Utah
WASHINGTON--Senate Finance Committee Chairman Orrin Hatch (R-Utah) 
today issued the following opening statement at a hearing examining the 
Obama Administration's Fiscal Year (FY) 2017 budget request for the 
Department of Health and Human Services (HHS):

    It's a pleasure to welcome everyone to today's hearing, which will 
be our third and final hearing on the President's proposed budget for 
Fiscal Year 2017. We've already had the Treasury Secretary and the IRS 
Commissioner appear before us. Today, we'll be talking with the 
Secretary of Health and Human Services.

    Thank you Secretary Burwell, for being here today. It has been over 
a year since we last had the pleasure of seeing you before the 
committee, and we are glad to have you back, because, as you might 
expect, we have a lot to discuss.

    I'll begin with the most obvious topic that I think people will 
want to discuss today. I don't think anyone was surprised to see that, 
in his final budget, President Obama chose to continue bolstering the 
so-called Affordable Care Act.

    Secretary Burwell, I think you know my opinion on this matter. In 
my view, providing any further funding for Obamacare would simply be 
throwing good money after bad, because, quite simply, the law is just 
not working.

    Let me offer a few examples that demonstrate this point.

    Problem Number One: While the administration and its supporters in 
Congress like to tout the numbers of ``newly insured'' people under the 
health law, the vast majority of those people have gained coverage 
through Medicaid, not through the health insurance exchanges.

    The relative decline in the number of uninsured people under 
Obamacare cannot be attributed to supposed improvements in the private 
insurance market, or to the coverage mandates imposed on employers and 
individuals. In fact, any increases in enrollment we've seen in private 
insurance plans have been almost entirely offset by the number of 
people who have lost the insurance they obtained through their employer 
before the law went into effect.

    But, according to a recent report, more than 9 million people 
gained coverage through Medicaid in 2014, the vast majority of them in 
states that expanded their programs.

    This is problematic for a number of reasons, most notably because 
Medicaid, as it is currently constituted, is a fiscally unsound program 
that is crippling state budgets all over the country. And, in terms of 
the quality of care, Medicaid is one of the worst health insurance 
options in the country.

    Long story short, I'm not sure that the administration should be 
bragging about enrolling people into Medicaid.

    Problem Number Two: The State Exchanges are not working.

    To date, the Centers for Medicare and Medicaid Services, which 
oversees the exchanges, has issued more than $5.5 billion in grant 
money to build exchanges in 17 states. Yet, every single state exchange 
faces significant budgetary shortfalls. For example, CMS gave $733 
million to establish state exchanges in Hawaii, Nevada, New Mexico, and 
Oregon. All four of these exchanges failed to become self-
sustaining and were forced to transition consumers to the federal 
marketplace, and it is increasingly unclear whether the government will 
ever recoup that money.

    Problem Number Three: Premiums are going up.

    HHS recently announced that premiums for benchmark plans will rise 
by an average of more than 7 percent nationwide, and many communities 
across the country are experiencing much larger rate increases.

    For example, one prominent health insurance expert reported earlier 
this year that Care First Blue Cross of Maryland, which controls 80 
percent of the market in that state, requested a 34 percent rate hike. 
The Blue Cross plan in Tennessee, which controls 70 percent of that 
market, asked regulators to approve an increase of more than 36 
percent.

    One of the chief claims proponents of the Affordable Care Act made 
when the law was being drafted and passed was that it would reduce 
health care costs. Clearly, by its authors' own standards, Obamacare is 
failing.

    I've listed three specific problems here today. There are obviously 
many others. I'm sure we'll talk about quite a few of them during this 
hearing.

    I have one final item to mention with regard to Obamacare, 
specifically as it relates to Puerto Rico. In his budget, the President 
requests nearly $30 billion in Medicaid funds for Puerto Rico, partly 
to avert a coming cliff in the island's program funding.

    It needs to be specifically noted that this cliff--this steep drop 
in future Medicaid funds for Puerto Rico--was purposefully written into 
the Affordable Care Act by its authors. Many people--including many who 
supported the law that instituted this cliff--have been quick to tell 
us that we need act swiftly to fix this problem to help alleviate 
Puerto Rico's debt crisis. What they won't tell us is why the cliff was 
written into the law in the first place.

    What's even more puzzling, Secretary Burwell, is that I have 
repeatedly asked senior administration officials, including you, for 
their views on legislation pending before Congress to address this 
cliff, including legislation that would provide precisely the funds the 
President is now requesting with his budget. Yet, until the day before 
yesterday, no one in the administration would offer any specific views 
on the matter.

    We know that some members of Congress have been all too willing to 
turn Puerto Rico into a political football. The fact that the 
administration, including HHS, is so reluctant to provide basic 
information about its views demonstrates, at least to me, that it also 
is more interested in politics than solutions when it comes to Puerto 
Rico. This is unfortunate, to say the least.

    Before I conclude, I'll try to end on a happy note. While there are 
many parts of the President's budget I find disagreeable--and that's 
being generous--I think there are some areas where we can find common 
ground.

    For example, the budget proposes several steps to address the 
appeals backlog in the Medicare claims payment system. Over the past 
year, this committee has worked with HHS to finds ways to address this 
problem. As you know, we even reported legislation on this issue.

    Secretary Burwell, we appreciate your partnership on this important 
issue. I hope you'll continue working with us to get our legislation 
passed this year.

    The budget also proposes additional spending to combat opioid 
abuse. This is an issue of critical importance to many members of this 
committee, so I am glad to see a focus on it in the budget and hope we 
can find some common ground there as well. As you can see, we have a 
lot to talk about today.

    I just want to once again thank Secretary Burwell for being here 
today. As I've said many times before, I don't envy your position. You 
have a difficult job. And, I expect that we'll be making it a bit more 
difficult today. But, we do need to address these issues and get some 
answers. I look forward to hearing your views on these important 
matters.

                                 ______
                                 
                 Prepared Statement of Hon. Ron Wyden, 
                       a U.S. Senator From Oregon
    Thank you, Secretary Burwell, for appearing before the Finance 
Committee to outline President Obama's budget proposal for Health and 
Human Services one final time. Today I'd like us to begin to talk about 
how Congress and the administration can build on the Affordable Care 
Act. And I use that term because the list of the ACA's achievements is 
long and growing.

    People can no longer be discriminated against and denied health 
coverage because of a preexisting condition. The number of Americans 
without health insurance is at or near its lowest point in half a 
century.

    Expanding Medicaid has put a big dent in the cost of uncompensated 
care, which has long been a major economic drag on hospitals across the 
country and a cause of rising premiums. So beyond the fact that 
expanding Medicaid is an opportunity to extend coverage to millions of 
people who struggle to get by, the numbers show that it has proven to 
be a good economic deal for states.

    And although there is certainly more work to be done, the rate of 
growth in national health care costs--the line on the graph that used 
to have budget economists quaking in their boots--has dropped 
significantly from where it was a handful of years ago. The law is not 
perfect, but that is undeniable progress to build on in ways that 
address the next big challenges in health care.

    For example, there are going to be a lot of spectacular cures 
available in the future. You're already seeing it with certain cancer 
treatments and Hepatitis C drugs. There is a real question, after the 
bipartisan investigation Senator Grassley and I conducted that looked 
into the pricing of one Hepatitis C treatment, as to whether our health 
care system will be able to afford these blockbuster drugs. Solving 
this issue is going to take bipartisan work, but I strongly believe 
that Democrats and Republicans can work together on health care.

    I think you're seeing an opening for bipartisanship on an ACA 
initiative called section 1332. It was born out of a proposal I first 
authored with former Senator Bennett--Bennett with two Ts. It is all 
about fostering innovations in the states, and it says they should be 
allowed to forge their own paths on health care as long as they meet 
the high bar set by the ACA--bringing high-quality, affordable health 
care to millions of Americans who didn't have access before.

    A recent op-ed ran in the Washington Post calling for all sides to 
come together and make these State Innovation Waivers work wherever 
possible. That op-ed was co-authored by Senator Tom Daschle and Speaker 
Newt Gingrich, who nobody would accuse of being two peas in a pod on 
most issues.

    This committee is also making bipartisan progress with respect to 
Medicare. It comes down to this: Congress has a responsibility to take 
Medicare's historic guarantee and reinforce it for a new generation of 
Americans. Too many older people in the program are one serious 
accident or illness away from a huge medical bill. And seniors too 
often are weighed down by a mountain of paperwork having to coordinate 
their own care--particularly those with chronic conditions.

    I believe this committee is closing in on a bipartisan plan of 
attack when it comes to improving chronic care. I want to thank 
Chairman Hatch for his partnership and Senators Warner and Isakson for 
being at the forefront of this issue. Bottom line, it's time to move 
Medicare away from a one-size-fits-all approach and begin doing more to 
take into account the individual needs of patients with chronic 
diseases.

    Now to step away from health care, I'd like to address the 
administration's important efforts to reduce poverty and help families. 
There has been real success over the past few years helping people who 
can find work climb out of poverty. In particular, making the 
expansions of the Earned Income Tax Credit and Child Tax Credit 
permanent as part of last year's tax deal is right up there with the 
ACA as some of the biggest anti-poverty achievements in decades. 
However, there's more that needs to be done helping families who remain 
struggling to find work. I was pleased to see that the administration 
acknowledged this issue and boosted the Temporary Assistance for Needy 
Families program in the budget.

    Finally, I should also note there is a real effort underway on this 
committee to improve the child welfare system in a number of areas that 
need urgent attention. Last fall, I introduced the Family Stability and 
Kinship Care Act to prevent traumatic foster care stays by helping 
parents keep their children safely at home. Right now, Chairman Hatch 
and I are working to wrap that bill into a broader child welfare 
proposal to reduce unnecessary foster care stays, lessen congregate 
care stays, and put in place stronger protections to keep kids in 
foster care safe. It's about making sure the system works better for 
the children, and I hope the committee is able to act very soon.

    Thank you again for joining us here today, Secretary Burwell, and I 
look forward to working with you on all these important issues over the 
year ahead. And thank you once more, Chairman Hatch--particularly for 
scheduling these three budget hearings this week.

                             Communication

                              ----------                              


           National Association of Chain Drug Stores (NACDS)

                      1776 Wilson Blvd., Suite 200

                          Arlington, VA 22209

                              703-549-3001

                             www.nacds.org

Introduction

The National Association of Chain Drug Stores (NACDS) thanks Chairman 
Hatch and the members of the Committee on Finance for the opportunity 
to submit the following statement for the record regarding pharmacy-
related provisions contained within the Fiscal Year 2017 Department of 
Health and Human Services (HHS) Budget. NACDS and the chain pharmacy 
industry are committed to partnering with Congress, HHS, patients, and 
other healthcare providers to improve the quality and affordability of 
healthcare services.

NACDS represents traditional drug stores and supermarkets and mass 
merchants with pharmacies. Chains operate more than 40,000 pharmacies, 
and NACDS's chain member companies include regional chains, with a 
minimum of four stores, and national companies. Chains employ more than 
3.2 million individuals, including 179,000 pharmacists. They fill over 
2.9 billion prescriptions yearly, and help patients use medicines 
correctly and safely, while offering innovative services that improve 
patient health and healthcare affordability. NACDS members also include 
more than 850 supplier partners and over 60 international members 
representing 22 countries. For more information, visit www.NACDS.org.

As the face of neighborhood healthcare, community pharmacies and 
pharmacists provide access to prescription medications and over-the-
counter products, as well as cost-effective health services such as 
immunizations and disease screenings. Through personal interactions 
with patients, face-to-face consultations, and convenient access to 
preventive care services, local pharmacists are helping to shape the 
healthcare delivery system of tomorrow--in partnership with doctors, 
nurses and others.

Concerns With Budget Proposal

NACDS appreciates HHS's proposed goals to reduce healthcare costs and 
produce a more efficient healthcare system; however, we have concerns 
with some proposals contained in the FY 2017 HHS Budget. HHS has 
proposed excluding brand and authorized generic drugs from the 
calculation of average manufacture price (AMP), thereby calculating 
Medicaid Federal Upper Limits (FULs) based only on generic drug prices. 
While the goal of this provision may be to decrease Medicaid costs, we 
believe it may in fact reduce access to prescription drugs and pharmacy 
services for Medicaid patients, resulting in increased overall 
healthcare expenditures.

Given that AMP has not yet been used as a basis for pharmacy 
reimbursement, and that AMP-based FULs remain in draft form, we believe 
the FY 2017 budget proposals changing the calculation of FULs are 
premature. It is necessary for the Centers for Medicare and Medicaid 
Services (CMS) to meet its goal of ensuring that pharmacies are not 
reimbursed below their costs using the reimbursement formula created by 
the Affordable Care Act. Therefore, we urge Congress to reject this 
proposal that would conflict with CMS's objective of ensuring fair and 
adequate reimbursement for pharmacies so that the Medicaid population 
does not suffer a loss of access.

The FY 2017 HHS Budget also includes a number of proposals to cut 
waste, fraud and abuse in the Medicare and Medicaid programs, including 
the ability to suspend coverage and payment for questionable Part D 
prescriptions, the ability to impose civil monetary penalties for 
providers and suppliers who fail to update enrollment records, and the 
authority to establish a program that would require that high-risk 
Medicare beneficiaries only utilize certain prescribers and/or 
pharmacies to obtain controlled substance prescriptions (i.e., a 
pharmacy lock-in program). NACDS applauds HHS for working to eliminate 
fraudulent activities from federal programs. However, NACDS urges HHS 
to move forward in a cautious manner so as not to disrupt beneficiary 
access or jeopardize beneficiary health. This can be done by ensuring 
that overly burdensome requirements are not placed on providers to the 
point of interfering with the ability to treat and care for patients. 
For example, any potential program which limits a beneficiary's ability 
to obtain their prescription medications must ensure legitimate 
beneficiary access to needed medications is not impeded. Policies to 
reduce overutilization must be balanced with maintaining access to 
prescription medications by the beneficiaries who need them most.

We have specific concerns that a lock-in provision may actually be a 
barrier to care as supply chain issues exist around controlled 
substance medications that are beyond the pharmacy's control. If a 
pharmacy is unable to obtain the medication for a lock-in patient, then 
it creates a barrier that could result in harm to the patient's health. 
Mechanisms must be developed and executed to allow a pharmacy, in 
consultation with the prescriber, to fill legitimate prescriptions 
without needlessly delaying treatment for beneficiaries. To minimize 
any potential harm and address supply issues, a beneficiary should be 
allowed to use all locations for a pharmacy organization if that 
pharmacy uses a common database with an integrated patient profile. 
Additionally, to reduce the potential for further abuse and confusion, 
claim rejections should occur at the point of sale, otherwise 
pharmacies will have no way to determine whether a beneficiary is 
enrolled in a lock-in program.

The FY 2017 budget includes several provisions to increase the 
utilization of generic drugs. NACDS applauds the inclusion of these 
important provisions, which would encourage the use of generic 
medications by Medicare Low Income Subsidy beneficiaries, and promote 
generic competition for biologics. Increasing generic utilization is 
one of the most effective ways of controlling prescription drug costs, 
and the generic dispensing rate of retail pharmacies--83.5 percent--is 
higher than any other practice setting.

NACDS believes there are other opportunities to reduce program spending 
while vastly improving the health of Medicare beneficiaries; including 
improving access for underserved beneficiaries and the better use of 
medication therapy management (MTM) services.

Pharmacists as Providers

As the U.S. healthcare system continues to evolve, a prevailing issue 
will be the adequacy of access to affordable, quality healthcare. The 
national physician shortage coupled with the continued expansion of 
health insurance coverage in recent years will have serious 
implications for the nation's healthcare system. Access, quality, cost 
and efficiency in healthcare are all critical factors--especially to 
the medically underserved. Without ensuring access to requisite 
healthcare services for this vulnerable population, it will be very 
difficult for the nation to achieve the aims of healthcare reform.

The medically underserved population includes seniors with cultural or 
linguistic access barriers, residents of public housing, persons with 
HIV/AIDS, as well as rural populations and many others. Significant 
consideration should be given to innovative initiatives within the 
medically underserved population to enhance healthcare capacity and 
strengthen community partnerships to offset provider shortages and the 
surge in individuals with healthcare coverage.

Pharmacists play an increasingly important role in the delivery of 
services, including key roles in new models of care beyond the 
traditional fee-for-service structure. Pharmacists are engaged with 
other professionals and participating in models of care based on 
quality of services and outcomes, such as accountable care 
organizations (ACOs). Pharmacists now commonly provide immunizations 
and medication therapy management (MTM) services.

In addition to medication adherence services such as MTM, pharmacists 
are capable of providing many other cost-saving services (subject to 
state scope of practice laws). Examples include access to health tests, 
helping to manage chronic conditions such as diabetes and heart 
disease, plus expanded immunization services. However, the lack of 
pharmacist recognition as a provider by third-party payors, including 
Medicare and Medicaid, limits the number and types of services 
pharmacists can provide, even though fully qualified to do so. Retail 
pharmacies are often the most readily accessible healthcare provider. 
Research shows that nearly all Americans (94 percent) live within 5 
miles of a retail pharmacy. Such access is vital in reaching the 
medically underserved.

We urge you to increase access to much-needed services for underserved 
Medicare beneficiaries by supporting H.R. 592/S. 314, the Pharmacy and 
Medically Underserved Areas Enhancement Act, which will allow Medicare 
Part B to utilize pharmacists to their full capability by providing 
those underserved beneficiaries with services (subject to state scope 
of practice laws) not currently reaching them. This important 
legislation would lead not only to reduced overall healthcare costs, 
but also to increased access to healthcare services and improved 
healthcare quality.

The Benefits of Pharmacist-Provided MTM

Poor medication adherence costs the U.S. healthcare system $290 billion 
annually. Pharmacist-provided services such as MTM are important tools 
in the effort to improve medication adherence, patient health and 
healthcare affordability. Studies have shown that patients who are 
adherent to their medications have more favorable health outcomes, such 
as reduced mortality, and use fewer healthcare services (especially 
hospital readmissions and ER visits). These studies included patients 
with cardiovascular disease, chronic obstructive pulmonary disease 
(COPD), high cholesterol and diabetes. Current MTM restrictions require 
that Medicare Part D beneficiaries suffer from multiple chronic 
conditions, be prescribed multiple medications, and meet a minimum 
annual cost threshold of $3,138 in 2015 for their prescriptions before 
they are eligible for Part D MTM. According to the CMS MTM Fact Sheet, 
approximately 85% of programs opt to target beneficiaries with at least 
three chronic diseases in 2014. This is a contributing factor to the 
lower than projected eligibility levels in the MTM program.

NACDS has long been supportive of exploring new and innovative 
approaches to improve the Part D MTM program. One of the approaches we 
believe can be successful is the Enhanced MTM Model pilot allowing Part 
D plans the opportunity to utilize new and innovative approaches to 
MTM, such as more efficient outreach and targeting strategies and 
tailoring the level of services to the beneficiary's needs. The 
Enhanced MTM Pilot program presents an opportunity to create better 
alignment of program incentives and has the potential to lead to 
improved access to MTM services for beneficiaries and greater 
medication adherence. NACDS believes that the MTM Pilot program should 
include retail pharmacies, as a successful model test must include 
retail community pharmacists. Medication management services provided 
by community pharmacists improve patient care; improve collaboration 
among providers; optimize medication use for improved patient outcomes; 
contribute to medication error prevention; improve hospital and 
readmission cost avoidance; and enable patients to be more actively 
involved in medication self-management.

Since the pilot is scheduled to last for 5 years beginning in 2017, we 
also urge lawmakers to explore new and innovative approaches to 
improving the MTM program that could be implemented in the short term. 
NACDS believes one short term approach is more efficiently targeting 
beneficiaries who can most benefit from the services that will improve 
medication adherence and overall program effectiveness. Congress 
recognized the importance of MTM on a bipartisan basis, including it as 
a required offering in the Medicare Part D program. We urge Congress to 
build on this earlier action and strengthen the MTM benefit in Medicare 
Part D through support of legislation such as that introduced by 
Senator Pat Roberts (R-KS) and Senator Jeanne Shaheen (D-NH), S. 776, 
the Medication Therapy Management Empowerment Act of 2015, which will 
provide access to MTM for beneficiaries with diabetes, cardiovascular 
disease, COPD, and high cholesterol.

Conclusion

NACDS thanks the Committee for consideration of our comments. We look 
forward to working with policymakers and stakeholders on these 
important issues.

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